id|nct_id|description
1825|NCT03542942|"~     Both toxicity and local relapse are major concerns in the treatment of locally advanced~     cervical cancer. The purpose of this study is to ameliorate both by integrating modern~     imaging (diffusion weighted magnetic resonance imaging; DW-MRI) into the treatment planning~     of modern radiotherapy. We want to evaluate the safety and effect of excluding the unaffected~     uterus (as determined on magnetic resonance imaging) from the treatment field. Meanwhile we~     want to explore the possible use of apparent diffusion coefficient values (DW-MRI) as~     biomarker of treatment response.~   "
1826|NCT03542929|"~     The type II diabetes is characterized by high levels of blood glucose followed by excessive~     insulin release so that the target cells become less sensitive and develop insulin~     resistance, maintaining hyperglycemic levels. The Whole body vibration session may improve~     the glucose metabolism in diabetic patients by reducing the peripheral blood sugar. Ten~     healthy elderly women and eight diabetic elderly women were allocated into two groups, and~     have made an acute whole body session.~   "
1827|NCT03542916|"~     The purpose of this study is to compare the pharmacokinetics and safety after a single~     subcutaneous or intravenous administration of CJ-40001 and NESP® in healthy male volunteers.~   "
1828|NCT03542903|"~     The effects of the ECT in schizophrenia ultra-resistant were studied in short times (4-6~     months in most studies with follow-up). The literature identified a high relapse rate of 32%~     in the weeks to months after ECT discontinuation. The use of the ECT in the prevention of the~     relapse is partially known. In an empirical way, experts recommend protocols of prevention of~     the relapse going from 6 to 12 months. Nevertheless, the profit of a long cure (12 months)~     compared with a short cure (6 months) was never determined. Therefore, the investigators~     decided to lead a prospective randomized controlled study in order to compare the response~     rates between the two strategies of clozapine and ECT combinations applied to URS patients.~     The treatment consisted either in a short therapy of six months or a longer course of therapy~     of twelve months. To the investigators' knowledge, it is the first study which compares two~     ECT strategies (both the short duration and the longer one) for the treatment of URS~     patients.~   "
1829|NCT03542890|"~     Baska® mask (Proact Medical Systems, Frenchs Forest NSW, Australia) is displayed in figure 1~     which is the latest addition to an array of supra-glottic airway devices in clinical use. It~     has a non-inflatable cuff, which is moulded to take up the shape of the supraglottic airway,~     potentially reducing the risk of oropharyngeal tissue and/or nerve damage induced by cuff~     over inflation, a known complication with other supraglottic airways. However, the cuff~     differs from other non-inflatable cuffs in that it is continuous with the central channel of~     the device. As the pressure increases with positive pressure ventilation ,the cuff itself is~     inflated which may improve the seal so reducing leak and make ventilation more efficient. The~     Baska mask has two ports (one for venting and other for gastric tube insertion ), so it~     incorporates an inlet that fits into the upper oesophagus and the dorsal surface of the cuff~     is moulded to direct any oropharyngeal contents away from the glottis and towards the side~     channels to which suction can be attached to facilitate aspiration of this space. These~     features may reduce the risk of pulmonary aspiration of secretions or gastric contents that~     accumulate in the supraglottic area. In addition, there is integrated bite-block, which~     reduces the risk of patients biting and blocking the airway. There is insertion tab which is~     an extended hand-tab attached to the cuff that permits the operator to control the degree of~     flexion of the device during the insertion. The Baska® mask is inserted in the neutral head~     position, which may reduce the need for neck manipulation. Initial experience with Baska®mask~     has demonstrated it to be a suitable airway device for procedures less than 2 hours or when~     endotracheal intubation is not required.~      I-gel airway (Intersurgical Ltd, Workingham, Berkshire,United Kingdom) is displayed in figure~     2 which is second generation supraglottic airway devices (SADs) that was introduced in 2007.~     The I-gel is a single use (SADs) composed of a soft ,gel-like, non-inflatable cuff made from~     a thermoplastic elastomer. It has a widened , flattened stem with a rigid bite block that~     acts as a buccal stabilizer to reduce axial rotation and mal-positioning and a port for~     gastric tube insertion. It is a latex free device that does not require digital insertion~     into mouth of patient. With an epiglottic rest and wider and shorter stem, the I-gel gives an~     optimal view of the glottis with a fiber- optic scope so a shorter tube is ideal for~     endotracheal tube placement. Moreover, I-gel can be inserted as fast as classic LMA~     (Laryngeal Mask Airway) with adequate ventilation in patients and has no major airway~     complications. Therefore, it could be a good alternative to classic LMA in emergency airway~     management or general anesthesia.~   "
1830|NCT03542877|"~     This study seeks to use Cabozantinib to treat those with Metastatic Colorectal Cancer who~     have not previously responded to treatment.~   "
1831|NCT03542864|"~     Medical Supervised Duodenal-Enteral Feeding for Overweight, Obesity and Increased Body Fat~     Percentage Treatment based on an intervention procedure performed by a Licensed Nutritionist~     Doctor for weight loss and loss of fat percentage in patients who need it.~   "
1832|NCT03542851|"~     This is a randomized, placebo-controlled, double-blind, crossover study of oral BTD-001 in~     adults with Idiopathic Hypersomnia.~   "
1833|NCT03542838|"~     This study evaluates the safety of resiniferatoxin in patients with moderate or severe knee~     pain due to osteoarthritis.~   "
1834|NCT03542825|"~     Iron supplementation during pregnancy is used to overcome the increased demand of the~     pregnant lady. Inorganic Iron has many drawbacks. Amino acid chelated iron is used as~     alternative with different bioavailability, side effect profile, and efficacy. Lactoferrin is~     recently studied as a prophylactic and treatment for Iron Deficiency during pregnancy. This~     study will compare the efficacy of these three available options.~   "
1835|NCT03542812|"~     Bronchopulmonary dysplasia (BPD) is a chronic lung disease that affects up to 35% of very low~     birth weight infants (VLBW < 1500 g). Based on the current numbers of VLBW infants born~     annually in the U.S., between 5,000-10,000 neonates will develop BPD each year. It is~     estimated that 8-42% of infants with BPD will develop pulmonary hypertension (PH). Moreover,~     it has been known since the 1980's that echocardiographic evidence of PH in infants with BPD~     is associated with up to 40% mortality.~      Treatment options to ameliorate PH in infants with BPD (BPD-PH) are limited. There have been~     no randomized clinical trials of any therapy in infants with BPD-PH. The standard care for~     the management of BPD-PH is to attempt to resolve the underlying lung disorder and the~     judicious use of oxygen as a potent pulmonary vasodilator. Using this management approach,~     which has not changed since the 1980's, the survival rates for infants with BPD-PH in the~     2000's has been reported to be 64% at 6 months and 53% at 2 years after diagnosis of PH. The~     lack of improvement in outcomes for the past 3 decades has led to the widespread agreement~     that novel and effective therapies are desperately needed for infants with BPD-PH.~      The goal is to develop oral L-citrulline clinically for the treatment of pediatric pulmonary~     hypertension associated with bronchopulmonary dysplasia (BPD-PH); before pursuing a large~     scale treatment trial, pharmacokinetic (PK) dose-finding, tolerability studies in patients at~     high risk of developing BPD-PH are warranted.~      The hypothesis is that oral L-citrulline will be well tolerated, without significant adverse~     effects in infants at high risk of developing pulmonary hypertension (PH) associated with~     BPD. The investigators propose to first characterize the PK profile of oral L-citrulline in~     order to define an appropriate dose range and treatment interval for infants at high risk of~     developing BPD-PH. Then using the doses and intervals generated by the PK profile, with a~     maximum dose of 3 g/kg/d, the investigators propose to evaluate the tolerability and ability~     to achieve the target study drug level (100-150 micromolar) in babies treated for 72 hours~     with oral L-citrulline. These studies will provide the data needed to design a full-scale~     randomized multi-center trial to evaluate the efficacy of oral L-citrulline therapy to~     ameliorate BPD-PH in human infants, a patient population that has a desperate need of new~     therapies.~   "
1836|NCT03542799|"~     This is a clinical study to observe the maximum tolerated dose (MTD) and the safety and~     feasibility of chimeric antigen receptor EGFR (EGFR -IL12 -CART) cells in metastatic patients~     with colorectal cancer.~   "
1837|NCT03542786|"~     The main purpose of this study is to evaluate a therapy for the inflammaging (premature~     aging).~   "
1838|NCT03542773|"~     To use 18F-DCFPyL imaging agent and PET/CT to detect none prostate cancer solid malignancies~     and schwannoma tumors.~   "
1839|NCT03542760|"~     This prospective, observational registry aims to collect real-world data regarding the safety~     and efficacy of ProvayBlue® (methylene blue 0.5%) used according to normal standard of care~     for the treatment of acquired methemoglobinemia. Methylene blue has been used for decades as~     a rescue medication for the treatment of methemoglobinemia, a rare and potentially~     life-threatening condition in which elevated levels of methemoglobin impede the delivery of~     oxygen from blood to body tissues. However, consistent prospective data about the safety and~     efficacy of this medication are sparse, simply because of the rarity of the disorder.~     ProvayBlue® received accelerated FDA approval for treatment of acquired methemoglobinemia in~     2016. This large, prospective, multi-center observational registry has been initiated to gain~     more information on the use of methylene blue in the treatment of acquired methemoglobinemia.~   "
1840|NCT03542747|"~     Comparison of time to ventilation based on the chest rising of the Airway Simulator between~     the iLTS-D and LMA Fastrach~   "
1841|NCT03542734|"~     The CIRCLE study is a single-center prospective observational study that enrolled individuals~     with cerebral small vessel disease (SVD), while free of known dementia or stroke (both~     cerebral infarction and hemorrhage). The patients will receive neuropsychological testing,~     retinal digital images and multimodal magnetic resonance imaging (MRI). Blood samples will~     also be collected. Recent small subcortical infarcts, lacunes, white matter hyperintensities,~     perivascular spaces, microbleeds, and brain atrophy will be evaluated on both baseline and~     follow-up brain MRIs. The investigators will explore the predictors of preogression of SVD~     and cognitive deficits.~   "
1842|NCT03542721|"~     The aim of the present clinical study is to evaluate the efficacy and safety of the DA-5515~     (Circulan Soft Cap.) in patients with chronic fatigue symptoms due to impaired blood~     circulation.~   "
1843|NCT03542708|"~     Premature ovarian failure is a loss of normal function before age 40, leading to infertility~     and hypoestrogenism. This study will involve only adult women with a diagnosis of POI.~     Participants will receive injections of autologous PRP in one randomly selected ovary.~   "
1844|NCT03542695|"~     This early phase I pilot trial studies how well 64Cu-DOTA-alendronate positron emission~     tomography (PET) imaging work in localizing and characterizing breast calcifications (small~     calcium deposits) in participants before undergoing mastectomy. Diagnostic procedures, such~     64Cu-DOTA-alendronate PET, may detect calcification and help doctors predict cancer~     associated calcification within breast tissue.~   "
1845|NCT03542682|"~     Rapid Action Insulin (RAI) absorption and action measured by time to reach maximum insulin~     concentration and glucose infusion rate.~   "
1846|NCT03542669|"~     This is a phase I clinical trial of cytotoxic T cell injection induced by dendritic cells~     loaded with 6B11 anti-idiotype minibody (6b11 - OCIK injection) for recurrent~     platinum-resistant epithelial ovarian cancer. Main purpose of this research is to determine~     the maximum tolerable dose (MTD) of 6B11-OCIK injection in the treatment of patients with~     epithelial ovarian cancer. Moreover, secondary purpose is to evaluate the safety and~     tolerance of autologous 6B11-OCIK injection in the treatment of patients with epithelial~     ovarian cancer. Thirdly, exploratory purpose is to obtain an initial understanding of effect~     of autologous 6B11-OCIK injection on patients with epithelial ovarian cancer, and evaluate~     the effect of autologous 6B11-OCIK injection on the immune system of patients with epithelial~     ovarian cancer.~   "
1847|NCT03542656|"~     In this project, we will try to enhance the diagnostic potentials of amyloid PET in CAA by~     combination of dynamic amyloid PET with MRI SWI and MR perfusion images. We will also try to~     investigate the roles of CAA in patients with drug-related ICH and validate the accuracy of~     clinical CAA diagnostic criteria. In addition, we will try to study the characteristics of~     long-term progression of amyloid deposition in CAA patients. This project will enroll 100~     patients with ICH, 30 patients with AD, and 30 control subjects. Each patient will receive~     the above image studies, followed by data analysis and comparison.~   "
1848|NCT03542643|"~     N-3 polyunsaturated fatty acids(N-3 PUFAs) is important in balancing the immune function and~     crucial for the developing brain. Deficiency in n-3 PUFAs might be linked to the poor~     cognitive performances resulting in inattention and hyperactivity in youth with attention~     deficit hyperactivity disorder (ADHD). N-3 PUFAs appears to be a promising treatment that is~     safe, beneficial to youth with ADHD. In this proposal, investigators aim the test the~     hypothesis that n-3 polyunsaturated fatty acids will be more effective than placebo in~     improving cognitive function in youth with ADHD after 12 weeks of intervention.~   "
1849|NCT03542630|"~     Despite the great progress in understanding the causes of infertility, the reason for the~     failure of pregnancy has not been discovered among 25% of infertile couples. Some studies~     have shown the negative impact of periodontal disease on the reproductive potential of women.~     It is known that there is an elevated level of matrix metalloproteinase 8 (MMP8) in the~     gingival fluid of patients with periodontitis. It is possible to establish a fast diagnosis~     of periodontitis by using a non-invasive assay based on monoclonal antibodies to two epitopes~     of MMP-8. The goal of the research is to use the above described assay in order to compare~     the level of MMP8 in the gingival fluid of infertile patients with the control group of~     fertile women, depending on the existence of periodontal disease. It is expected to find~     significantly higher values of MMP8 in infertile patients in relation to the fertile patient~     with/without periodontitis. The prompt treatment of periodontitis in preconception care of~     this group of women could have a significant impact on the improvement of fertility and~     ability to achieve pregnancy.~   "
1850|NCT03542617|"~     To compare the effects of preoperative intravenous Dexamethasone between 10 mg and 40 mg with~     placebo on Postoperative Pain After Primary Total Hip Arthroplasty~   "
1851|NCT03542604|"~     This is a randomized pilot study to better understand the relationships among insomnia,~     weight loss, and breast cancer. This study will assess the effectiveness of a sleep~     intervention prior to a web- and phone-based weight loss program.~   "
1852|NCT03542591|"~     500 participants of the vegan/vegetarian congress VegMed are to be included, which should~     answer once (cross-sectional study) a medicine socio-behaviorist questionnaire on the topic~     supplementation of critical nutrients in a plant-based diet at the VegMed congress on~     21/04/2018. The aim of the study is to understand how experts in this field behave and~     whether actions taken follow official recommendations.~   "
1853|NCT03542578|"~     This study will evaluate whether ultrasound performed during outpatient visit is effective in~     early diagnosis of fatty liver.~   "
1854|NCT03542565|"~     A prospective, randomized, controlled study designed to assess whether digital virtual~     reality (VR) models, created from existing CT scans and MRIs, provide surgeons with an~     improved understanding of their patients' anatomy, resulting in more efficient operations~     (robotic partial nephrectomy) and improved patient care.~   "
1855|NCT03542552|"~     Antepartum hemorrhage is defined as bleeding from or within the female genital tract,~     occurring from 28+0 weeks of pregnancy and till delivery of the fetus. it occurs in 3-5% of~     pregnancies and is an important cause of perinatal and maternal morbidity and mortality~     worldwide~   "
1856|NCT03542539|"~     Dermoscopy is a non-invasive method that allows evaluation of colors and microstructures of~     the epidermis, the dermoepidermal junction, and the papillary dermis not visible to the naked~     eye. These structures are specifically correlated to histologic features. The identification~     of specific diagnostic patterns related to the distribution of colors and dermoscopy~     structures can better suggest a malignant or benign pigmented skin lesion. The use of this~     technique provides a valuable aid in diagnosing pigmented skin lesions~   "
1857|NCT03542526|"~     To review the accuracy of electrocardiography in screening for left ventricular hypertrophy~     in patients with hypertension.~   "
1858|NCT03542513|"~     The aim of this study is to analyse biomarkers in first-void urine for improved follow-up of~     women treated for high grade cervical intraepithelial neoplasia (CIN).~   "
1859|NCT03542500|"~     Objectives:~      The objectives of this research proposal are to study the delivery of an evidence-based~     mental health intervention in the alternate setting of youth employment programs tied to~     regional economic development and to examine the use of an Interagency Collaborative Team~     Approach (ICTA) as an implementation scale-up strategy that addresses the human resource~     shortage and related access to care and capacity challenges in low- and middle-income~     countries (LMICs). Specifically, this study aims to examine the incorporation of the~     evidence-based Youth Readiness Intervention (YRI) into a program that promotes employment~     among youth through a pilot study and scale-up intervention study in Sierra Leone.~      Study population:~      The study population includes youth, ages 18-26, with elevated t-scores on assessments of~     functional impairment and emotional dysregulation, who live in the Kono, Koinadugu and~     Kailhun districts of Sierra Leone.~      Scale-up study design:~      For the scale-up study, a Hybrid Type 2 Effectiveness-Implementation Cluster Randomized~     Three-arm trial will be employed. We estimate the entire sample size for the scale-up study~     to be 3,630 participants, including 1200 youth, 10 agency heads, 20 intervention~     facilitators, and 2400 third-party informants. Upon enrollment into the study, youth will be~     assigned to community level sites based on geographical location. Each of these community~     level sites will make up one cluster. These clusters will be randomized into the three study~     conditions: the control condition - where youth do not receive the YRI or the EPP but are~     able to utilize as available resources in the community - the EPP-only condition, and the~     YRI+EPP condition. Data will be collected at baseline, 3-months, and 12-months follow-up.~      Scale-up study outcomes:~      Primary outcomes of the scale-up study are focused on process and implementation aspects~     including a costing analysis, measures of fidelity and the sustained delivery of the YRI~     within a Collaborative Team Approach to intervention delivery, training and supervision.~     Secondary outcomes are development of emotional regulation skills for healthy coping and~     assessment of the YRI's ability to improve youth's interpersonal skills and functional~     impairment.~   "
1860|NCT03542487|"~     This multi-site randomized tral aims to test methods of increasing adoption and integration~     of blood glucose monitoring into electronic medical records, and to measure the impact of~     widescale adoption on health status of patients with diabetes. To investigate determinants of~     adoption, the research will combine and test doctor and patient focused approaches to~     encouraging patient use of blood glucose flow sheets through the online patient portal,~     MyChart. Adoption will be measured on both the extensive and intensive margin: the number of~     patients who enter data into the flowsheets at all during the study period, and the mean~     number of entries per patient during the study period. Conditional on statistically~     significant increases in adoption, the study will examine corresponding intent-to-treat~     effects on patient A1c, and consider other indicators of possible mechanisms through which~     A1c improves or does not improve.~   "
1861|NCT03542474|"~     The overall objective of this study is to determine how high intensity endurance exercise~     affects both cognition and the signs and symptoms of Parkinson's disease as well as if~     certain brain structures and functions also change with this exercise.~   "
1862|NCT03542461|"~     The study's hypothesis is that using Nivolumab as early switch maintenance, after 4-6 cycles~     of standard first-line chemotherapy, might improve survival in patients with advanced stage~     squamous NSCLC.~   "
1863|NCT03542448|"~     Optical coherence tomography is a non-invasive and non-contact imaging modality that enables~     two-dimensional cross-sectional and three-dimensional volumetric imaging of tissue~     architecture.~   "
1864|NCT03542435|"~     This is a randomized, double-blind, placebo-controlled, multiple ascending dose study~     conducted at one study center in the United States. Safety and tolerability will be assessed~     throughout the study and serial blood samples and urine samples will be collected for the~     safety and pharmacokinetic assessment of SXC-2023.~   "
1865|NCT03542422|"~     An Exploratory study of Amapinib for patients with esophageal cancer .~   "
1866|NCT03542409|"~     This study evaluates the use of specialized magnetic resonance imaging (MRI) techniques~     including magnetic resonance (MR) perfusion and 2-hydroxyglutarate (2HG) spectroscopy in the~     surgical treatment of gliomas. Participants will undergo an MR perfusion scan or 2-HG~     spectroscopy prior to surgery and intra-operatively.~   "
1867|NCT03542396|"~     Physical activity can reduce symptoms of mental disorders like sleep disorders, anxiety~     disorders, major depression and ADHD. However, in Germany there are no group therapeutical~     exercise programs for psychotherapy patients in an outpatient context. The current study aims~     to examine the effectiveness of a manualized exercise program, named ImPuls, which consists~     of a supervised and non-supervised endurance training and group psychotherapeutic elements.~   "
1882|NCT03542201|"~     Participants will receive in random order on format of brief description of systematic review~     summary on health intervention. One group will receive standard plain language summary, while~     another will receive Cochrane blog shot, containing only few information about the efficacy~     of the intervention. After reading, their task will be to answer several questions about the~     material they have read.~   "
1945|NCT03541382|"~     The aim of this study is to determine the benefits, costs and safety of community-led~     delivery of HIV self-testing (HIVST) kits in rural Malawi, with a focus on testing and~     linkage to care and prevention services among defined population sub-groups: men, adolescents~     aged 15-19 years old, and adults aged 40 years or older.~   "
2341|NCT03536208|"~     This study aims to asses the effect of warfarin on markers of AXL pathway in patients with~     pancreatic adenocarcinoma.~   "
1868|NCT03542383|"~     A debilitating and common symptom in Gulf War Illnesses (GWI) is the inability to retrieve~     words. This affects one's conversations, ability to fluidly exchange information verbally and~     retrieve information from memory. The investigators have discovered 3 brain regions - the~     PreSupplementary Motor Area (preSMA), caudate nucleus, and the thalamus - that are essential~     for word retrieval. They have also detected abnormal EEG signals related to these regions in~     GWI patients who have problems retrieving words.~      The investigators have used their model of verbal retrieval to design a noninvasive,~     nonpharmacological treatment that uses High Definition transcranial Direct Current~     Stimulation (HD tDCS). Using HD tDCS, they deliver small amounts of electric current to areas~     of the head to stimulate specific brain regions. The objective is to determine if delivery of~     HD tDCS over the preSMA will improve performance in GWI veterans with a verbal retrieval~     deficit. The investigators will administer pre-treatment tests of verbal retrieval measures~     while recording brain electrical activity. They will then administer 10 sessions of HD tDCS~     over the preSMA (20 minutes a session) in half the veterans. The other half will go through~     the same procedures, except the current will not be turned on (called the sham condition).~     The investigators will then compare performance between the active and sham group and~     assess if the treatment had a significant effect on performing verbal retrieval tasks and if~     there is a change in the ERP markers to account for how the treatment worked. If the~     treatment is found to be effective it will be offered to those in the sham group at the~     study's end.~      The investigators predict this treatment regimen will lead to positive effects on a person's~     daily functions, especially improved conversational abilities, with few, if any, side~     effects. They hope to outline the standard procedures for physicians to perform the treatment~     by creating a manual on how to apply the treatment in a clinical setting so that it will be~     quickly available to use in multiple sites if the proposed study demonstrates that it is~     efficacious. This treatment can be made widely available for Warrior Transition Units,~     military clinics, and VA medical centers. In addition, if successful, this could potentially~     lead to development of other targets of stimulation to improve other cognitive deficits in~     GWI, and help alleviate verbal fluency deficits associated with other disorders.~   "
1869|NCT03542370|"~     The European Association for the Study of Diabetes (EASD) guidelines have not made any~     specific recommendations regarding the Dietary Approaches to Stop Hypertension (DASH) diet, a~     dietary pattern that emphasizes fruits and vegetables, low-fat or non-fat dairy, limiting~     saturated fat intake and usually also recommends limiting sodium intake. To update the~     recommendations, the Diabetes and Nutrition Study Group (DNSG) of the EASD commissioned an~     umbrella review of systematic reviews and meta-analyses using the Grading of Recommendations~     Assessment, Development, and Evaluation (GRADE) approach to summarize the available evidence~     from recent systematic reviews and meta-analyses of prospective cohort studies and randomized~     controlled trials of the relationship between the DASH dietary pattern and cardiometabolic~     risk.~   "
1870|NCT03542357|"~     To develop a pragmatic migraine model the investigators will induce headache in healthy~     volunteers and in patients with migraine without aura with aCalcitonine Gene Related Peptide~     (CGRP). If the headache responds to sumatriptan, the model can be used to test new drug~     candidates.~   "
1871|NCT03542344|"~     The primary objective of this trial is to investigate the safety and tolerability of BI~     1015550 in healthy male subjects following oral administration of single rising doses.~      Secondary objectives are the exploration of the pharmacokinetics (PK) including dose~     proportionality of BI 1015550 after single dosing.~   "
1872|NCT03542331|"~     The goal is to investigate whether endometrial flushing with Lipiodol enhances fertility.~     Therefore, anatomo-pathological, histochemical and transcriptional changes of the endometrium~     after Lipiodol bathing in a general population of healthy volunteers will be determined.~   "
1873|NCT03542318|"~     The inclusion of Pulmonary Rehabilitation (PR) as part of the management of pulmonary~     fibrosis although being highly recommended and recommended in guidelines still sees studies~     exploring the outcomes from such an intervention limited. The present study aims to~     contribute to the available literature by investigating the effects of a high intensity,~     12week PR programme on functional and quality of life measures in patients with a diagnosis~     of pulmonary fibrosis.~   "
1874|NCT03542305|"~     This is a Phase 1, open-label, multi-center, single treatment study in subjects with normal~     renal function and varying degrees of renal impairment.~   "
1875|NCT03542292|"~     In this randomized controlled study, 222 pregnant women who admitted to Zeynep Kamil Women~     and Children's Health Training and Research Hospital from December 2016 and July 2017 were~     included. They were randomized into study(111) or control(111) group when they delivered~     vaginally. In study group; umbilical cord was clamped from fetal side but unclamped from~     maternal side. After that unclamped side of umblical cord was left open to drain the blood~     until the flow ceased. In control group the umblical cord was clamped both sides.~   "
1876|NCT03542279|"~     The study is to explore the treatment effects and long-term prognosis (12 months and 24~     months after immunotherapy) by comparing the plasma exchange (PE) combined with medication~     therapy with the simple medication immunotherapy in autoimmune encephalitis (AE) patients, to~     make clear that the combination of PE and medication therapy can be more effective than the~     treatment of simple medication immunotherapy. As well as, the study is to explore whether PE~     is also effective in AE with autoantibody synthesis in the sheath, positive cerebrospinal~     fluid antibody and seronegative.~   "
1877|NCT03542266|"~     This is a phase II, multi-center study to determine the efficacy and safety of first-line~     CC-486 plus CHOP in patients with PTCL who have received no prior systemic therapy. The study~     has a sample size of 20, and follows two-stage minimax design for primary efficacy analysis.~   "
1878|NCT03542253|"~     This experiment has now collected 50 cases, all through CT chest scans and blood exosome~     detection. Twenty-two patients underwent surgical treatment and 14 tissue specimens were~     examined for cancer and paracancerous tissue exosomesWe found that exosomal micor-A was~     highly expressed in early stage lung cancer tissues and was significantly higher than~     paracancerous tissues. The micor-A in the adjacent tissues was significantly higher than that~     in peripheral blood exosomes~   "
1879|NCT03542240|"~     This study will investigate the effects of curcumin on the structure/function of the body by~     investigating whether targeted improvement of intestinal barrier function by supplementation~     with oral curcumin will result in attenuation of lipopolysaccharide (LPS) translocation~     and/or intestinal inflammation.~   "
1880|NCT03542227|"~     The aim of the study is to develop robust analytical protocols for first-void urine sample~     preparation and antibody assays to monitor vaccine induced immunity against HPV (Human~     Papillomavirus).~   "
1881|NCT03542214|"~     In this phase I study 6 patients with inoperable colorectal cancer is treated with calcium~     electroporation to establish safety and efficacy of the treatment.~   "
1946|NCT03541369|"~     Evaluate the safety and tolerability of AMG 427 in adult subjects with relapsed/refractory~     AML. Estimate the maximum tolerated dose (MTD) and / or a biologically optimal dose (eg,~     recommended phase 2 dose [RP2D]).~   "
3560|NCT03520270|"~     A multicenter point prevalence study in Turkish intensive care units.~   "
1883|NCT03542188|"~     Should we prioritize thrombectomy or thrombolysis in acute stroke? Finding the answer to this~     question will improve treatment and outcome for stroke patients only by changing triage and~     transportation. And it will have implications for stroke patients around the world.~      The investigators propose a national investigator-driven, multi-center, randomised~     single-blinded clinical trial to investigate which treatment strategy is superior in patients~     with acute stroke and suspected large vessel occlusion (LVO): direct transport to a~     comprehensive stroke center for early endovascular therapy (EVT) or to a primary stroke~     center for early IV thrombolysis followed by secondary transport to a comprehensive stroke~     center for EVT if needed.~      Effective reperfusion therapy marks a new era within stroke medicine and has been driving~     major changes in the organization of care within the last decade. Timely thrombolysis and/or~     EVT in acute ischemic stroke is a key factor for improved outcome. Major stroke occur in 25%~     of all cases and is caused by LVO. Major strokes have approximately 60% risk of severe~     disability or death at three months if not treated. EVT is superior to thrombolysis in~     strokes caused by a LVO, but EVT is only performed in specialized centers due to the~     complexity of the treatment and need for skilled neurointerventionalists.~      A simple stroke severity score has been developed, that can identify most patients with LVO~     in the pre-hospital setting. This enables selection of patients with a suspected LVO to be~     transported without delay directly to a comprehensive stroke center for EVT while potentially~     bypassing a nearer primary stroke center for IV-thrombolysis.~      Study results will have major impact of future acute stroke treatment and organization.~   "
1884|NCT03542175|"~     The purpose of this study is to test the safety of a study drug called Rucaparib,~     administered in combination with the type of radiation therapy that is usually given to women~     with your form of breast cancer.~   "
1885|NCT03542162|"~     To report the surgical results of primary rhegmatogenous retinal detachment (RRD) repaired by~     27G pars plana vitrectomy (PPV) combined with Healaflow patch and air tamponade, and do not~     need prone position postoperation.~   "
1886|NCT03542149|"~     A single-centre Phase 1b study to assess the safety, tolerability, pharmacokinetic profile,~     and antimalarial activity of single doses of coadministered artefenomel (OZ439) and~     piperaquine phosphate (PQP) against early Plasmodium falciparum blood stage infection in~     healthy adult volunteers.~   "
1887|NCT03542136|"~     Oxaliplatin is a cytotoxic platinum compound and is one of the chemotherapeutic agent used in~     advanced colorectal cancer. It is used combined with Fluorouracil (5 FU) and Leucovorin. The~     main and most suffering side effect of oxaliplatin is polyneuropathy. Oxaliplatin-induced~     polyneuropathy (OIPN) can be acute and/or chronic neurotoxicity.~      The early detection of the neurotoxicity and changing the medication dose and/or schedule can~     prevent its development. It has been used different neurotoxicity scales in grading OIPN. In~     this study the investigators try to investigate whether the evaluation of the vibrotactile~     perception VTP, by using a multi frequency tactilometry in a patients hand and foot is a good~     indicator and superior to the standard of care to detect the underlying OIPN in patients~     undergoing adjuvant chemotherapy treatment with FOLFOX, FLOX or XELOX regime.~   "
1888|NCT03542123|"~     A single-arm study to observe NeuroTronik Cardiac Autonomic Nerve Stimulation (CANS) Therapy~     System hemodynamic and other physiologic effects.~   "
1889|NCT03542110|"~     This is a phase IV, multi-center, double-blind, randomized, placebo- controlled study~     evaluating the effect of alirocumab on SVG atherosclerotic disease burden, as assessed by~     IVUS at baseline and following 78 weeks of treatment in subjects with at least one~     intermediate SVG lesion receiving optimal statin therapy. Subjects will be randomized 1:1~     into 2 treatment groups: alirocumab 150 mg subcutaneously every 2 weeks or placebo~     subcutaneously every 2 weeks.~   "
1890|NCT03542097|"~     This is a biological study in patients with advanced Ewing Sarcoma who received, according,~     clinical practice, temozolomide and irinotecan The O6-methylguanine-DNA methyltransferase~     (MGMT) methylation status, will be correlated with the disease clinical data and with the~     disease response~   "
1891|NCT03542084|"~     Diabetes currently affects 25.8 million people in the U.S. Patients with diabetes are~     generally managed, at least initially, by a primary care practitioner (PCP). As the~     prevalence of diabetes continues to rise, PCPs are under increased pressure to achieve~     recommended glycemic targets. Failure to achieve these targets has been shown to increase~     clinical complications and cost of care.~      Endocrinology referral is common for those patients not meeting A1c goals. Unfortunately,~     access to specialty endocrinology care is limited and patients routinely wait weeks or months~     before being seen. Electronic consultation (e-consult) is a new and innovative delivery model~     that has the potential to provide greater access to specialty care. The current system at~     Massachusetts General Hospital (MGH) allows PCPs to electively place an e-consult to solicit~     specialist input. Specialists in turn review the patients chart, relevant data and the~     clinical question and respond within the electronic medical record. E-consults have been well~     received by both patients and physicians, not only at MGH, but also across many centers in~     the US. With that said, the e-consult system remains in its infancy and current literature~     largely focuses on process metrics without hard clinical end-points.~      One way to optimize care for patients with diabetes is to automatically trigger an~     endocrinology e-consult for those not meeting A1c targets. The goal of this project will be~     to conduct a rigorous scientific evaluation of auto-triggered e-consults across Massachusetts~     General Hospitals affiliated primary care practices. The e-consults will be unsolicited and~     triggered based on inclusion criteria that include a1c and date of last PCP visit. This~     project will leverage an existing diabetes population health registry that is being used~     currently for ongoing diabetes care initiatives.~   "
1902|NCT03541941|"~     Patients usually experience some level of pain after their hernia repair. To control pain~     after the operation, surgeons have many options. One of them is to make some injections of~     pain blocker medications into the nerves that are responsible for the sensations the~     abdominal wall.This procedure is called TAP block (transversus abdominis place block). These~     medications are called local anesthetics, and there is a variety of medications that can be~     used. One of such medications is called Exparel® (Liposomal Bupivacaine). Exparel® has the~     potential benefit of lasting more hours than regular anesthetics. Although this drug is being~     used with increasing frequency, the investigators do not have good quality studies~     investigating the benefits of using this medication during a hernia repair, especially when~     compared to other types of local anesthetics (Bupivacaine Hydrochloride) or when compared to~     not injecting this medication at all. This study aim to investigate if Exparel®, when~     injected in the nerves of the abdominal wall during hernia repair can: (1) reduce the dose of~     additional opioid medications (morphine and similar) needed to achieve good pain control and~     (2) result in lower pain scores. The hypothesis is that Exparel® will result in a 30%~     decrease in the total requirements for opioid medications during the first 72 hours after~     surgery. Patients will be randomized to receive either Exparel®+Bupivacaine Hydrochloride,~     Bupivacaine Hydrochloride or Placebo (normal saline) during the operation through a TAP~     block. All patients will receive a patient controlled analgesia device after the operation,~     where patients can simply push a button every time they feel pain and the device will~     administer a dose of opioid medications. The investigators of the study will record the~     necessary amount of opioids used by the patients to achieve good pain control and also record~     pain scores several times during hospital stay.~   "
1903|NCT03541928|"~     This is a prospective phase II study to assess the efficacy and toxicity of HSV-tk+~     valacyclovir gene therapy in combination with androgen deprivation therapy, brachytherapy,~     external beam radiotherapy, and prostatectomy in previously untreated high-risk prostate~     cancer.~   "
1892|NCT03542071|"~     eMOM is a randomized, controlled trial to compare the effects of two different dietary~     interventions during pregnancy. The comparison is based on tissue glucose content (using~     continuous glucose monitoring system) in pregnant women and on neonate body composition. The~     recruited women (n=50) have early gestational diabetes mellitus (diagnosed before gestational~     weeks 13), are obese (BMI >30 kg/m²) and of Caucasian origin. Of the study diets, one is~     moderately carbohydrate restricted and the other one is high on plant-based protein with an~     emphasis on healthy Nordic foods. The study has three two-week study periods that are carried~     out on approximately gestational weeks 13-14 (period I), 24-25 (period II) and 34-35 (period~     III). Continuous glucose monitoring and other measurements (accelerometer, 3-day food record,~     gut microbiota, serum lipids, metabolomics, epigenetics etc.) are done during these study~     periods. At the beginning of the study, before study period I, the participants are~     randomized to either one of the intervention diets. The first study period consists of a~     crossover phase in which the participants receive three days' worth of food according to one~     of the intervention diets (according to the randomization) after which there is a three-day~     wash-out period. After the wash-out period, the participants receive three days' worth of~     food according to the other diet. After the first study period, a nutritionist advises the~     lastly followed intervention diet to the participant and the diet is followed until delivery.~     To ensure the diet is followed, the participant gets at least five personal counselling~     sessions, mobile reminders, recipes and food items. After delivery, the infant's body~     composition, epigenetic markers of cord blood and placenta, gut microbiome and urine~     metabolomics are measured.~   "
1893|NCT03542058|"~     The objective of this research is to describe the burden of subclinical anthracycline therapy~     related cardiac dysfunction( ATRCD) by applying international guideline on Uganda cancer~     patient and to evaluate the significance of treating subclinical ATRCD with carvedilol.~   "
1894|NCT03542045|"~     The study was designed as prospective, single-arm, multi-center which was intended to broadly~     capture all patients as the technology is adopted.~   "
1895|NCT03542032|"~     To compare the jaw thrust maneuver with the conventional technical methods to place the I-Gel~     laryngeal mask~   "
1896|NCT03542019|"~     Restoration of endodontically treated teeth requires a means to protect the cusps from the~     wedging forces of occlusion. When there is extensive loss of tooth structure, cuspal coverage~     is warranted. Usually this is in the form of indirect restoration. Traditionally, full~     coverage crowns have been used which would require further removal of sound tooth structure.~     Recently, adhesive alternatives have been introduced which allow for conservation of tooth~     structure.~      Different materials can be used for this purpose. The evidence on the long-term survival of~     these materials is scarce. This study aims to investigate the short and medium-long term~     survival rate of these prostheses.~   "
1897|NCT03542006|"~     Examine the efficacy of brinzolamide for the treatment of central serous chorioretinopathy~   "
1898|NCT03541993|"~     Background: Vaso-active polyphenols have been proposed to enhance cognitive performance. Oral~     administration with the non-flavonoid polyphenol, resveratrol, has been found to modulate~     cerebral blood flow (CBF); yet, this has not resulted in subsequent predicted benefits to~     cognitive performance in young, healthy samples. It has been argued that ageing populations~     who are noted suffer a reduction in CBF and cognition, may possess the subtle deficits to~     benefit from resveratrol administration. The use of hypoxia has been previously tested by~     this research group to mimic the decrease in cognitive functioning associated with ageing.~      Objectives: The current investigation aimed to further assess if a reduced fraction of~     inspired oxygen (12.7% FiO2) could provide an experimental model of aging in a young, healthy~     sample. Moreover, the current study also aimed to assess if resveratrol can attenuate the~     deficits elicited by the reduction in oxygen supply via increased CBF.~      Design: This repeated measures, double blind, placebo controlled, balanced design assessed~     the cognitive and CBF effects of resveratrol in hypoxia (equivalent to 4000 m above sea~     level) and normoxia (sea level).~      Methods: Twenty-four participants arrived fully fasted (except water) for 12 hours before~     completing a baseline measure of a cognitive task battery, and taking the treatment for the~     day (either 500 mg resveratrol or inert placebo). Following a 45 min absorption period,~     participants completed 3 full repetitions of a cognitive test battery. Changes in cerebral~     hemodynamics were measured by near-infrared spectroscopy throughout the full testing session.~   "
1899|NCT03541980|"~     The purpose of this study is to determine whether IV acetaminophen can decrease the need for~     subsequent opioid administration in the acute management of sickle cell crisis pain in the~     pediatric emergency room.~   "
1900|NCT03541967|"~     Main objectives~        -  The first main objective is to evaluate the non-inferiority of the ADHEAR system~          compared to the PONTO 3 SUPERPOWER softband system in terms of average tonal gain.~        -  The second main objective of the study is to evaluate the superiority of the ADHEAR~          system compared to the PONTO 3 SUPERPOWER softband system in terms of comfort.~      Secondary objectives~        -  Evaluate skin reactions with ADHEAR and PONTO 3 SUPER POWER on softband.~        -  Evaluate and compare perception in silence and noise with ADHEAR and PONTO 3 SUPER POWER~          on softband.~        -  Evaluate and compare the subjective auditory perception with ADHEAR and PONTO 3 SUPER~          POWER on softband.~        -  Evaluate the satisfaction and use of ADHEAR.~   "
1901|NCT03541954|"~     The purpose of this study is to assess and validate the clinical criteria of sensitization~     (Convergences PP criteria) selected by the expert consensus with neurophysiological sensory~     testing.~   "
1904|NCT03541915|"~      Postoperative nausea and vomiting (PONV) is commonly accompanied in patietns undergoing~     surgery under general anesthesia. The patients undergoing laparoscopic gynecologic surgery~     have multiple risk factors for developing PONV such as female gender, nonsmoker,~     postoperative opioids, and laparoscopic surgery. Thus, it is important to prevent PONV in~     these patients.~   "
1905|NCT03541902|"~     The goal of this clinical research study is to compare the safety and effectiveness of~     cabozantinib and sunitinib when given to patients with metastatic (has spread) variant~     histology renal cell carcinoma (vhRCC), a type of kidney cancer.~      This is an investigational study. Cabozantinib and sunitinib are both FDA approved and~     commercially available for the treatment of advanced kidney cancer, including vhRCC.~      The study doctor can explain how the study drugs are designed to work.~      Up to 84 participants will be enrolled in this study. All will take part at MD Anderson.~   "
1906|NCT03541889|"~     The primary objective is to evaluate whether an investigational nuclear medicine test (FLT~     imaging) distinguishes delayed engraftment from graft failure after hematopoietic stem cell~     transplantation (HSCT, which is when the patient's blood system is depleted and a new healthy~     blood system infused) and~      Objectives:Secondary:~        -  Map the cellular pathway to subclinical (before the new cells are present in the blood)~          engraftment after cord blood and haplo-identical engraftment through FLT imaging,~          identifying the earliest marrow site of settling.~        -  Evaluate the safety of FLT for patients at highest risk for graft failure.~        -  Determine whether levels of TK1, an investigational blood test to determine growth of~          new cells, correlate with graft failure or delayed engraftment, versus those of patients~          who had on-time engraftment.~        -  Explore other blood markers of subclinical engraftment.~   "
1907|NCT03541876|"~     Helicobacter pylori is a major human pathogen associated with significant morbidity. The~     treatment oriented by the antibiogram or PCR (Polymerase Chain Reaction) should be privileged~     in children. However, the optimal treatment for the eradication of pediatric H. pylori~     infection is still not established.~      No French consensus conference on the management of H. pylori infection in children taking~     into account the epidemiological data available for this infection has been published. The~     description of diagnostic and therapeutic management procedures has not yet been specifically~     described according to the country of birth of children. The main objective is to collect~     data enabling the establishment of a French observatory of Helicobacter pylori in children in~     order to provide a national database.~   "
1908|NCT03541863|"~     What Comes After Fulvestrant? A Real World Multicenter Retrospective Study-Treatment After~     Progression of Fulvestrant Among Metastatic Breast Cancer Patients in China.~   "
1909|NCT03541850|"~     This phase II trial studies how well stereotactic body radiation therapy works in treating~     patients with prostate cancer that has not spread to other parts of the body and have~     undergone surgery. Stereotactic body radiation therapy is a specialized radiation therapy~     that sends x-rays directly to the tumor using smaller doses over several days and may cause~     less damage to normal tissue.~   "
1910|NCT03541837|"~     Evaluation of the benefit effects of Peri-Operative analgesia by Continuous Bilateral Erector~     Spinae Plane block(ESP) for Open Cardiac Surgery: A case series prospective study with a~     comparison a retrospective case series (Before and after)~   "
1911|NCT03541824|"~     The purpose of this study is to examine the efficacy of an intervention aimed at promoting a~     healthy lifestyle and reducing risk factors associated with eating pathology, nonsuicidal~     self-injury, and suicidal behavior. We are also interested in assessing whether this~     intervention has the potential to prevent future symptoms of eating problems and self-harm~     urges and behaviors. The broader goal of this research is to identify factors that may help~     us better understand the prevention of self-harm behaviors and develop more effective~     treatments for these problems.~   "
1912|NCT03541811|"~     Hemophilia is an inherited disease caused by deficiency in varying degrees of clotting~     factors VIII and IX. Depending on the percentage of clotting factor in the blood the disease~     is categorized as severe (<1%, characterized by spontaneous bleedings), moderate (1-5%)~     and mild (>5%). If untreated, recurrent bleeding into the synovial joints often results in~     irreversible damage due to destruction of the cartilages and progressive joint impairment.~      3d-gait analysis has been demonstrated as valid method to assess abnormal gait patterns and~     to monitor disease progression in patients with hemophilia (PWH). Furthermore, its outcomes~     facilitate the design of individually tailored therapeutic programs. In contrast to~     radiological examinations, 3d-gait analyses take place under weight-bearing conditions, which~     is a relevant issue in terms of weight-induced pain.~      This study aims to explore the applicability of 3-d gait analysis as biomarker (gait~     deviation index) for functional impairments in PWH. Besides 3-d gait scores, secondary~     endpoints such as biomarkers reflecting cartilage damage and a laterality-ratio of leg muscle~     mass (in the case of one-sided target joints) will be tested for their ability to detect~     functional impairments in young adults with hemophilia.~      Based on sample size calculation, 24 subjects aged 16-45 years, able to walk without aids or~     assistance will be included in each of the two groups: control (healthy, male), PWH (severe~     or moderate, treated prophylactically). Subjects suffering from functional impairments caused~     by other conditions than hemophilia, patients with bleedings within 30 days prior to the~     examination, PWH treated with immune-tolerance therapy and/or not successfully treated~     present or past high-titer factor VIII or FIX inhibitor will be excluded.~      Subjects will pass through a set of examinations (medical history, clinical examination,~     3d-gait analysis, anthropometrics, body composition analysis, venipuncture, and urine~     sampling) and carry an accelerometer device for seven consecutive days.~      Confounder adjusted group differences will be assessed by ANCOVA with contrasts and~     Bonferroni correction. Correlations between the applied examination approaches will be~     assessed.~      An evidence based health promotion program including follow-up examinations, physical~     activity promotion, and tailored physiotherapy are being envisaged as a follow-up project~     (JOSEPHA phase 2).~   "
1913|NCT03541798|"~     85 patients were randomly allocated to the left lateral, squat and traditional sitting~     position for combined spinal-epidural anesthesia. In this study aimed at the orthopedic~     surgery patient comparison of the effect of the position given to a patient on the success of~     combined spinal-epidural anesthesia application.~   "
1914|NCT03541785|"~     This study follows a group of patients admitted to the PICU who are identified as being at~     risk for developing acute kidney injury. The investigators will use risk-stratification,~     biomarker testing, and a functional assessment to predict patients who will become fluid~     overloaded and develop acute kidney injury.~   "
1915|NCT03541772|"~     Nutritional supplements containing antioxidants seem to decrease toxicity associated with~     Radiotherapy (RT) and Chemotherapy (CT) in patients with malignant head and neck tumors.~     Oncoxin-Viusid® (OV) is a nutritional supplement with antioxidant, immunomodulator and~     antitumor effects.~   "
1916|NCT03541759|"~     Postoperative pain management plays an important role in elective shoulder surgery. The aim~     of this randomized quantitative study is to compare two frequently used postoperative pain~     regimes (hydromorphone versus piritramide) regarding onset and duration after the~     effectiveness of the single-shot interscalene block has diminished.~   "
1917|NCT03541746|"~     The aim of present study is to evaluate the effect of the use of platelet rich plasma in~     decreasing recurrence of intrauterine adhesions after its lysis.~   "
1918|NCT03541733|"~     Adequate bowel preparation is required for magnetic resonance enterography (MRE) which can be~     achieved by two methods including administering contrast solution after mid-gut tubing and~     taking contrast solution orally. We present the design of randomized controlled trial to~     compare the efficacy and compliance of bowel preparation through mid-gut tubing with taking~     contrast orally for MRE in patients with Crohn's disease (CD).~   "
2977|NCT03527901|"~     The aim of this study to evaluate the diagnostic accuracy of a new qualitative aMMP‐8 POC~     test in different periodontal health and disease and as compared to the established~     quantitative laboratory method (ELISA)~   "
1919|NCT03541720|"~     PET (positron emission tomography) scans combined with a radioactive tracer will be used to~     identify and analyze tumors. Currently, the most common tracer used to analyze neuroblastoma~     tumors is called 123I-mIBG. However, the picture it provides is not always clear enough to~     see the very small areas of the disease.~      18F-DA (18F-fluorodopamine) has been shown to be safe and more effective than 123I-mIBG in~     analyzing the tumor pheochromocytoma, which is closely related to neuroblastoma.~      With this research study, the investigators plan to meet the following goals:~        -  Investigate to see if 18F-DA is safe to administer to pediatric patients with known or~          suspected neuroblastoma or pheochromocytoma~        -  Examine where in the body 18F-DA goes.~        -  Obtain information comparing 18F-DA to 123I-mIBG to see if 18F-DA could replace~          123I-mIBG in the future.~      About 20 people, with known or suspected neuroblastoma or pheochromocytoma, will take part in~     this study at St. Jude.~   "
1920|NCT03541707|"~     This study is a randomized double blind placebo controlled EEG monitored study of deep rTMS~     treatment to treat adolescent depression.~      The present study is the first well controlled study to examine the possible clinical utility~     of deep TMS to treat a severe and life threatening disorder- depression, among adolescents.~      Patients will be allocated, based on chance, to receive active therapy or a as if~     stimulation, with no knowledge of patient or therapist who receives the active therapy. In~     addition, a simple and feasible monitoring of brain waves (EEG) will be conducted. This~     addition will enable us to evaluate the possibility to use biological markers to predict the~     course of therapy.~      Our hypothesis is that 1. patients receiving the active therapy will improve significantly~     more than those who received the as if treatment. 2. There will be no significant side~     effects. 3. The brain waves (as measured by the EEG) will predict treatment response.~   "
1921|NCT03541694|"~     This is a passive enhance safety surveillance (ESS) of Stamaril® vaccine in Korea. The~     objective is to collect suspected related adverse events following vaccination with Stamaril®~     in routine practice.~   "
1922|NCT03541681|"~     The main objective is to evaluate pain and muscle strength in the upper extremities after~     treatment with cervical transforaminal injection of glucocorticoid vs. transforaminal~     injection of local anesthetic injection in patients with cervical radiculopathy. The~     investigators hypothesizes that there are correlations between radiculopathy and muscle~     weakness.~   "
1923|NCT03541668|"~     This is a randomized, rt-PA controlled, open-label phase 3 clinical study to evaluate the~     efficacy and safety of human recombinant urokinase(rhPro-UK) versus rt-PA thrombectomy for~     patients with acute ischaemic stroke in 4.5 hours after stroke onset .~   "
1924|NCT03541655|"~     The safety and activity of a single, 3.5 mL dose of F14 (celecoxib) concurrent with standard~     of care analgesia administered following total knee replacement will be compared to standard~     of care analgesia alone.~   "
1925|NCT03541642|"~     This study will identify perceptions of PrEP in women who inject drugs (WWIDs) and develop~     and pilot test a targeted intervention that will be embedded in a large, urban syringe~     exchange program through an extensive formative evaluation process. Using perceptual mapping,~     an innovative marketing evaluation technique, WWIDs' PrEP perceptions will be incorporated~     into messaging in targeted counseling, materials, and text messaging to encourage PrEP~     adherence. This will then be tested in a pilot Randomized Controlled Trial (RCT) by comparing~     it to a general PrEP intervention to assess for uptake and adherence to PrEP, as well as~     improved self-efficacy and lower decisional conflict.~   "
1926|NCT03541629|"~     Objective. The objective of the study is to verify and validate the data collected in the~     Spanish EURECCA Esophagogastric Cancer Registry between January 2014 and December 2017~     through an audit process. It is also intended to describe the initiation and implementation~     of this Registry as well as its early outcomes.~      Methods. An audit of registered cases (esophageal, esophagogastric junction and gastric~     cancer resectable patients undergoing surgery) from 01/01/2014 to 12/31/2017 and a~     descriptive analysis of these data will be performed.~      Expected results. The study could show that the Spanish EURECCA Esophagogastric Cancer~     Registry is a reliable source of information, valid for carrying out specific and exhaustive~     analysis that may lead to high quality publications in indexed journals. It is also expected~     to generate a high impact based on the large number of cases included in the Registry,~     favoring new research projects.~      Relevance. The standardization of the data collection is essential to compare outcomes~     between different centers, regions and countries. This study will allows us to verify the~     integrity of the collected data as well as its accuracy, a critical aspect to gain~     credibility for future studies using the Registry data.~   "
1927|NCT03541616|"~     Multicentre, prospective cohort study in patients with a history of HF with preserved or~     reduced ejection fraction admitted to hospital with acutely decompensated HF. Eligible and~     consenting patients will be enrolled at 3 Hamilton, Ontario area hospitals and receive 28-day~     ECG monitoring implemented at the time of hospital discharge. Patients will be followed for a~     total of 1 year from hospital discharge.~   "
1928|NCT03541603|"~     Phase 2 study to evaluate the efficacy and safety of intermittent levosimendan compared with~     placebo in hemodynamic improvement with exercise in PH-HFpEF subjects~   "
1929|NCT03541590|"~     In a recently published meta-analysis (Sharaiha, Gastrointestinal Endoscopy, 2017), it is~     reported that percutaneous transhepatic biliary drainage (PTBD) is less clinical successful,~     causes more adverse events and needs more re-interventions than endoscopic ultrasound guided~     biliary drainage (EUBD) in patients with malignant, extrahepatic bile duct obstruction. The~     conclusion was, that EUBD should be prefered in this clinical setting in future.~      An improved technique of PTBD may provide better results for coming comparative studies.~      The investigators of this retrospective study therefore analyzed all PTBDs that were~     performed in a period of nine years in a tertiary referral hospital. In this cohort, the~     analysis focused on PTBDs with primary metal stent implantation by endoscopic luminal~     guidance.~   "
1930|NCT03541577|"~     TruePhysioTM Sensor-equipped Ultrathin Pressure Microcatheter (referred to as TruePhysioTM~     Microcatheter below) is a novel device for evaluating the functional significance of coronary~     stenosis. This study will compare the differences, if any, between the coronary fractional~     flow reserve (FFR) measured by the TruePhysioTM Microcatheter and the Pressure Wire.~   "
1931|NCT03541564|"~     This is a study to investigate the experimental medication BMS-986165 in healthy participants~     in order to study the effects it has on electrocardiogram results.~   "
1932|NCT03541551|"~     To the best of Investigator knowledge, no studies to this date have compared the safety and~     efficacy of ologen® Collagen Matrix in Primary congenital glaucoma (PCG) patients undergoing~     trabeculectomy. Given that filtration surgery is usually less successful in patients with~     developmental glaucoma; the purpose of this study is to compare combined trabeculectomy with~     trabeculotomy (CTT) with adjuvant ologen® Collagen Matrix versus CTT without ologen® in~     children with PCG. Investigator hypothesis is that CTT with ologen® Collagen Matrix would be~     as effective as CTT in IOP control, but with reduced scarring and long term healthier bleb~     morphology.~   "
1933|NCT03541538|"~     This study evaluates the hypoalgesic effect of global and specific cervical joint~     manipulation in healthy individuals. At first the participants received one of the~     interventions and after 48 hours, the other.~   "
1934|NCT03541525|"~     GR-Ex is a program labelled by Labex (Laboratory of Excellence) by the French Ministry of~     Higher Education and Research. This program aims to develop the means to improve knowledge in~     the physiology and pathologies of erythropoiesis, red blood cells and iron metabolism, and to~     develop new therapeutic protocols capable of providing added value in terms of innovation.~   "
1935|NCT03541512|"~     This is a study designed to learn more about the use of an online remote education and~     mindfulness practice program for the pain and anxiety associated with provoked localized~     vulvodynia.~   "
1936|NCT03541499|"~     This is a randomized, partially blind, placebo controlled, clinical trial evaluating a single~     intranasal dose of BPZE1 in healthy adults. The study will evaluate a lyophilized formulation~     of the product, with the goal of testing for the optimal dose for subsequent clinical trials.~     Fifty healthy adults, 18-49 years of age will be randomized to one of the four following~     treatment groups in a 3:3:3:1 ratio: 10^7 colony forming units (CFU) of BPZE1 administered by~     VaxINator device, 10^9 CFU of BPZE1 administered by VaxINator device, placebo administered by~     VaxINator device, 10^9 CFU of BPZE1 administered by needleless tuberculin syringe. Study~     duration will be approximately 12 months with a subject participation duration of~     approximately 6 months. The primary objective of this study is to assess the safety and~     tolerability of a single intranasal dose of either 10^7 or 10^9 CFU of lyophilized BPZE1~     vaccine.~   "
1937|NCT03541486|"~     This is a phase 2 study testing the initial efficacy of adding pharmacological ascorbate~     (vitamin C) to standard radiation and chemotherapy for treatment of pancreatic cancer.~   "
1938|NCT03541473|"~     The objective of this research project is to determine in elderly subjects (>50 year old) by~     31P-MRS the brain concentration of phosphorous metabolites species and fluxes, before and~     after consumption of 2 commercially available oral nutrition products~   "
1939|NCT03541460|"~     This study will systematically assess epigenome methylation changes in participants of the~     Israel multi-ethnic centenarian study cohort, which includes citizens of Israel aged 95 years~     and older, compared to their offspring and younger controls.~   "
1940|NCT03541447|"~     Autosomal Dominant Polycystic Kidney Disease (ADPKD) is a leading cause of End Stage Kidney~     Disease (ESKD) worldwide. Elevated levels of 3', 5' - cyclic AMP (cAMP) play a central role~     in the pathogenesis and progression of the disease. Vasopressin antagonists and somatostatin~     analogues, which indirectly reduce adenyl cyclase 6 activity, have been found to markedly~     reduce renal tubular cell proliferation and cyst growth in experimental models of ADPKD. In~     combination, the two treatments show a clear additive effect and may significantly reduce~     renal cystic and fibrotic volume as well as cAMP levels to wild type levels.~      The vasopressin antagonist Tolvaptan and the somatostatin analogue Octreotide share a similar~     renoprotective effect also in human disease.~      Both medications effectively slow total kidney and cystic volume (TKV and TCV, respectively)~     growth and glomerular filtration rate (GFR) decline in patients with ADPKD. The short-term~     effect of both medications appear to be larger when the GFR is normal or even higher than~     normal and kidney volumes are still relatively stable. On the basis of experimental data, it~     is conceivable that Tolvaptan and Octreotide LAR should have an additive effect also in human~     disease, during initial treatment as well as in the long-term. To address the working~     hypothesis of an additional short-term effect of Tolvaptan and Octreotide, we propose to run~     a pilot, explorative, randomized, placebo-controlled, clinical trial with a Cross-Over Design~     to compare the short-term effects of Tolvaptan monotherapy and Tolvaptan plus Octreotide LAR~     combination therapy on TKV as assessed by MRI, and on GFR as directly measured by the iohexol~     plasma clearance technique in ADPKD patients with normal (80 to 120 ml/min/1.73m2) kidney~     function or even kidney hyperfiltration (GFR ≥120 ml/min/1.73m2).~   "
1941|NCT03541434|"~     Adenotonsillar hypertrophy is the principal cause of obstructive sleep apnea of childhood,~     yet little is known with regard to its pathophysiologic and molecular mechanisms. The present~     trial examines potential bioclinical markers of the disease.~   "
1942|NCT03541421|"~     Background Medication administration errors occur in around 20% of administrations. Patient~     involvement (PI) is recommended and self-management support e.g. as self-administration of~     patient's own drugs during hospital stay is a central component of practising PI.~      Aim To investigate whether PI in administering drugs in hospital affects the number of~     medication errors, medication adherence and patient satisfaction and whether it is~     economically advantageously.~      Materials and methods The PhD Study is performed at the Department of Cardiology, Randers~     Regional Hospital.~      The study design is complex intervention and the PhD study therefore consists of three~     studies. In study 1 the intervention is developed, investigated for feasibility and~     pilot-tested in small scale. In study 2 and 3 the intervention is evaluated within a RCT with~     outcomes as medication errors, medication adherence, patient satisfaction and~     cost-effectiveness.~   "
1943|NCT03541408|"~     The current study aims to elucidate the effectiveness of a preventative delirium protocol in~     patients older than 65 years of age undergoing elective surgery.~   "
1944|NCT03541395|"~     The study is designed to identify and validate new protein biomarkers in blood related to~     testosterone activity. Thirty healthy young males underwent pharmaceutical castration to~     lower testosterone levels. After three weeks the subjects received an intramuscular injection~     of testosterone undecanoate. Blood samples from just before pharmaceutical castration, three~     weeks after castration, and one week after injection of testosterone undecanoate were~     collected representing normal testosterone levels, low testosterone levels, and testosterone~     at eugonadal levels.~   "
43673|NCT02995148|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
1947|NCT03541356|"~     This is a Phase IIa randomized, double-blind, placebo controlled, single ascending dose (SAD)~     study to compare the safety, tolerability and PK/pharmacodynamic of intranasal L-dopa~     following administration of INP103 to that of placebo in PD patients in the presence of~     benserazide during an OFF episode.~   "
1948|NCT03541343|"~     This is a multi-centre, prospective, open-label, single-arm, first-in-man clinical~     investigation. The patients enrolled in this clinical trial will undergo elective surgery for~     pelvic fusion. Following harvesting of autologous bone graft form the iliac crest, the donor~     site will be reconstructed with a new scaffold known as GreenBone.~      GreenBone is a ceramic reabsorbable scaffold which is obtained by the transformation of wood.~     It has a very similar structure to bone.~      The aim of the study is to evaluate the safety of using the GreenBone in humans and also to~     evaluate its capacity to promote new bone formation at the donor site.~   "
1949|NCT03541330|"~     The primary objective is to evaluate the experience with the information received on the~     disease by the healthy brothers and sisters of childrens with malignant haemopathy at the~     Centre Hospitalier Régional et Universitaire of Lille~   "
1950|NCT03541317|"~     The overarching goal of this study is to improve the delivery of an established,~     evidence-based intervention (cognitive-behavioral therapy-CBT) in Michigan schools through~     different implementation strategies designed to better educate school professionals.~     Specifically, the study will assist the ongoing Transforming Research into Action to Improve~     the Lives of Students (TRAILS) Program by evaluating different ways to educate school~     professionals (SPs) to improve their delivery of CBT to high school students and ultimately~     improve student mental health outcomes in the state of Michigan. The three educational~     approaches are Replicating Effective Programs (REP), Coaching, and Facilitation.~   "
1951|NCT03541304|"~     While surgery remains the standard treatment for rectal cancer, some patients still firmly~     refuse surgery for various reasons. Here, we conducted this retrospective observation study~     to discuss the feasibility of high-dose radiotherapy combined with chemotherapy in treating~     rectal cancer We retrospectively collect data of rectal cancer patients who were treated with~     high-dose radiotherapy plus chemotherapy in Sun Yat-sen University Cancer Center from April~     1st, 2006 to July 30th, 2017. Patients gave up surgery before any treatment would have~     received one course of high dose radiotherapy (GTV60-70Gy/30-35f). Patients with tumor~     residual after neoadjuvant chemoradiotherapy but insisted non-operative treatment would have~     received 2 courses of radiotherapy (1st: GTV 45-50Gy/25f, 2nd: GTV 30/15f). The chemotherapy~     regimens included Capox, FOLFOX, or capecitabine at the discretion of the treating physician.~      After treatment, patients were followed every 3 months for the first two years, at least~     every 6 months in the year thereafter. Recurrence, early and late toxicity were recorded.~      Analyses were performed using SPSS software, version 19.0 (SPSS, Chicago, IL). Local~     recurrence and distant metastasis rate, progression free survival, and overall survival were~     calculated using the Kaplan Meier Method and were compared by log-rank test.~   "
1952|NCT03541291|"~     We will test an ultrasound device that uses sound waves to detect the fetal heart beat, and~     use this device to tell the MRI scanner when to collect pictures of the fetal heart. This~     will help freeze motion of the fetal heart, to make MRI pictures sharper. This will be~     important for assessing human fetal heart disease, an active area of research at our~     institution.~   "
1953|NCT03541278|"~     Internal Mammary Lymph Node (IMLN) and Axillary Lymph Node (ALN) are regarded as the first~     station of lymphatic drainage in breast cancer, serving as an important reference for lymph~     staging and decision-making. Although the concept of Internal Mammary Sentinel Lymph Node~     Biopsy (IM-SLNB) has been included in the AJCC guidelines since the 6th edition, technical~     bottlenecks and clinical benefits still remained to be the main reasons limiting its clinical~     application:~      Technical bottlenecks: In previous clinical practice, the internal mammary visualization rate~     was very low (13% on average, 0% -37%) under the guidance of the traditional radionuclide~     injection technique, which became a technology bottleneck restricting the widespread of~     IM-SLNB. After continuous exploration, our center invented the modified injection technique~     of injecting the nuclide tracer into the mammary gland layer at 6 and 12 o'clock around the~     areolar under the guidance of ultrasound, as well as increasing the injection volume to~     increase the local tension. A high internal mammary imaging rate of 71% was obtained, which~     laid a foundation for the further study and clinical application of IM-SLNB.~      Clinical benefits: The IM-SLNB is a method to assess IMLN metastatic status in a minimally~     invasive way, which may improve the system of regional staging and guide precise IMLN~     treatment. However, based on the current IM-SLNB indication, the internal mammary metastasis~     rate was only 8%-15%, and it only had little influence on treatment strategy, which led to~     the controversy of its clinical application. Previous studies of extended radical mastectomy~     showed that in ALN positive patients the IMLN metastasis rate was 28-52%, while in ALN~     negative patients the metastasis rate was only 5-17%. Therefore, the continuation of the~     previous A-SLNB indication (clinical ALN negative) to IM-SLNB is apparently not in line with~     the current clinical practice, but further evaluation of internal mammary metastasis status~     in clinical ALN positive patients may receive greater benefit.~      This prospective multicenter study attempted to perform IM-SLNB with our modified injection~     technique both in clinical ALN negative and positive patients for the first time. Through~     analyzing metastasis rate of IMLN as well as the influences it had on decision making, we~     hoped to develop more accurate indication for IM-SLNB and guide the individualized precise~     treatment of IMLN.~   "
1954|NCT03541265|"~     Pain management after total knee arthroplasty is essential for optimized clinical outcomes~     and higher satisfaction. Exparel (Pacira Pharmaceuticals, Parsippany, New Jersey, USA) is a~     long-acting Bupivacaine extended release liposome compound that is injected peri-articularly~     or as regional block. The purpose of this study was to compare the analgesic efficacy of~     single administration of Exparel for local peri-articular infiltration versus adductor canal~     regional block.~   "
1955|NCT03541252|"~     A prospective clinical, uncontrolled, open-label, explorative phase IIa trial on patients~     with histologically- confirmed superficial and nodular basal cell carcinoma (BCC) . The study~     assesses tolerability and tumor clearance after laser-assisted topical delivery of two~     synergistic chemotherapeutic agents, cisplatin and 5-fluorouracil (5-FU) in BCC patients.~   "
1956|NCT03541239|"~     The aim of the study is to investigate how phosphorylation of STAT3, p38 MAPK, ERK and AKT~     reacts to remote ischemic conditioning (rIC) in healthy humans, which could point to~     mechanisms by which rIC may protect against ischemia-reperfusion injury (IRI), and if rIC~     affects immune reactivity.~   "
1957|NCT03541226|"~     The purpose of this study is to develop tools to detect, measure, monitor and predict axonal~     damage in the course of CIS and during Multiple sclerosis (MS), in order to be able to~     consider as early as possible an adaptation of the background treatment in patients with MS.~     patients with radiological criteria of poor long-term clinical course.~   "
2026|NCT03540316|"~     This study evaluates the use of short dental implants to support mandibular overdenture~     together with the use of laser therapy for treatment of patients with atrophic ridges. All~     participants will receive laser therapy; half of participants will receive two short implants~     and the other half will receive four short implants.~   "
43674|NCT02995135|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
1958|NCT03541213|"~     Iron is involved in essential functions of the body. It allows the transport of oxygen in the~     blood, via hemoglobin, at the muscular level, via myoglobin, and it is also involved in~     cellular metabolism in general, in particular for the production of ATP at the mitochondrial~     level, within the cytochromes and iron-sulfur proteins of the respiratory chain.~      Recently, iron deficiency has been identified as an important prognostic factor in heart~     failure patients. Iron therapy improves symptoms and physical performances of heart failure~     patients, even in the absence of anemia. As a result, the correction of iron deficiency is~     now proposed as one of the therapies for heart failure. However, the pathophysiology of the~     association between cardiac dysfunction and iron deficiency is still poorly understood.~      We previously developed a mouse model of iron deficiency without anemia, in which we observed~     impaired physical performances, a decrease of left ventricular ejection fraction, and a~     decrease in mitochondrial complex I activity. These abnormalities were normalized after iron~     injection. These animal data suggest that iron deficiency is responsible for left ventricular~     dysfunction secondary to mitochondrial I complex abnormalities, and that iron therapy~     corrects them.~      Iron deficiency is very common in the preoperative period of cardiac surgery, affecting 40 to~     50% of patients. During this surgery, it is possible to perform a myocardial biopsy without~     risk to the patient.~      The purpose of this study is to verify in patients requiring valvular heart surgery, if iron~     deficiency is responsible for a decrease in mitochondrial complex I activity and a decrease~     in cardiac function during the perioperative period, and to verify whether iron treatment~     improves these abnormalities.~   "
1959|NCT03541200|"~     An open-label, long term extension study of MT-8554 in postmenopausal women experiencing~     moderate to severe vasomotor symptoms who completed Study MT-8554-A01~   "
1960|NCT03541187|"~     Scientific evidence has shown that, over the past two decades, the combination of cockroach~     allergy and cockroach exposure is one of the most important factors contributing to the~     dramatic increase in asthma morbidity seen in inner city children with asthma. Therefore, a~     major goal of the Inner City Asthma Consortium (ICAC) is to evaluate the efficacy of~     cockroach immunotherapy in inner city asthma.~      The primary objective of the study is to determine if asthma severity can be improved by~     cockroach subcutaneous immunotherapy (SCIT) treatment.~   "
1961|NCT03541174|"~     The purpose of the study is to show the blood pressure lowering effect of aprocitentan, a new~     drug, when added to other anti-hypertensive drugs of patients with difficult to control~     (resistant) high blood pressure (hypertension), and to show that blood pressure reduction is~     kept for long period of time.~   "
1962|NCT03541161|"~     The purpose of the study is to find best post-operative rehabilitation protocol after total~     mastectomy and immediate reconstruction with tissue expander insertion. This study compared~     outcomes of two post-operative rehabilitation protocols ; conventional protocol, which~     immobilized shoulder and upper arm motion for a month and early rehabilitation protocol~     with short-term immobilization period and early mobilization.~   "
1963|NCT03541148|"~     Malignant melanoma, responsible for 75% of deaths from skin cancer. Current therapeutic~     options have poor response, many adverse events and high costs. For this reason, a study with~     nutritional supplement Oncoxin-Viusid was carried out. According to previous studies, it has~     an antitumor, immunomodulatory effect and to potentiate the antiproliferative effect of~     standard chemotherapeutic agents in different locations and stages of cancer.~   "
1964|NCT03541135|"~     Population aging makes it necessary to identify factors related to unhealthy aging. The~     purpose of this study is to examine the association between ideal cardiovascular health, diet~     and other lifestyles and biological risk factors (either clasical or emergent) and the risk~     of physical and cognitive function impairment and mortality in a cohort of community-living~     individuals aged 65 years and over.~   "
1965|NCT03541122|"~     Acetabular dysplasia often accompanies by acetabular bone hyperplasia and osteonecrosis of~     the femoral head. These pathological changes can alter the position of the center of the~     femoral head. Thus, measurement errors will be generated on the anteroposterior radiographs~     of the adult pelvis involving centre-edge angle, acetabular angle (Sharp angle), and~     acetabular head index, eventually resulting in the inaccurate diagnosis of acetabular~     dysplasia. Herein, the investigators describe the protocol to verify three novel X-ray~     indicators, including offshoring index (OFI), moving up index (MUI) and teardrop baseline~     offshoring index (TBOI) of the femoral head. All data will be expressed as relative ratios,~     as the investigators expect to make an accurate diagnosis through avoiding the generation of~     errors resulting from measurement angles.~   "
1966|NCT03541109|"~     Cardiovascular diseases (CVD) are the leading cause of mortality and morbidity worldwide. The~     most important aspect of CVD secondary prevention is adherence to guideline-indicated~     pharmacological therapy which globally remains low. In previous studies, a Polypill~     containing fixed dose combination of essential drugs have improved patient adherence to these~     drugs. The effect of such a strategy on pharmacological therapy uptake, cost-effectiveness,~     and CVD recurrence in our setting will be assessed in this study. Participants hospitalized~     in three referral hospitals in Isfahan, Iran because of an acute coronary syndrome (ACS) or~     revascularization procedure (PCI or CABG) will be randomized to either receiving Polypill or~     four components of Polypill separately. Patient recruitment will be carried out at the time~     of patient discharge from the hospitals.~   "
1967|NCT03541096|"~     This study investigates repetitive cold-water exposure on brown fat activity assessed using~     Positron Emission Tomography - Computed Tomography (PET/CT) scans and infrared thermography.~     Furthermore we will assess glucose control upon winter-swimming. Obese prediabetic men and~     women will be randomized to winter-swimming or control conditions for 4 months.~   "
2008|NCT03540550|"~     Inulin-type fructans (ITF) are fermentable dietary fibres that can confer beneficial health~     effects through changes in the gut microbiota. However, their effect on gut sensitivity and~     nutritional behaviour is a matter of debate.~      The investigators evaluated, in healthy individuals, the impact of shifting from their usual~     food habits towards a diet based on the daily consumption of ITF-rich vegetables on gut~     microbiota, gastro-intestinal symptoms and food-related behaviour.~   "
2027|NCT03540303|"~     Evaluation of the safety and efficacy of CAR19 T cells carrying cytoplasmic activated PD1 in~     patients with refractory relapsed B-cell lymphoma~   "
2978|NCT03527888|"~     To evaluate the safety and efficacy of patients with recurrent and metastatic bone tumors.~   "
1968|NCT03541083|"~     Blinatumomab is a new active bispecific monoclonal antibody for treatment of lymphoid~     malignancies, including ALL (acute Lymphoblastic Leukemia ) whose activity for remission~     induction needs to be explored in combination with standardized treatment in order to improve~     outcome of this disease which is still lethal in most adult patients. Ultimate proof of~     efficacy resides in an increase of reaching MRD ( minimal residual disease) negativity,~     prolongation of that response, and long-term survival. Since hematological response rate in~     adult ALL is high already and defining long-term survival in a large clinical trial takes~     many years, this trial aims to improve the strength of the MRD response as defined by~     achieving complete MRD negative response (ie, < 10^-4) after the first consolidation phase~     including blinatumomab. This MRD response will be assessed by Real-Time Quantitative~     Polymerase Chain Reaction (RQ-PCR) analysis of patient-specific Ig/TCR (T-cell receptor )~     gene rearrangements. When MRD data are missing, MRD positivity will be assumed. Although~     younger (up to 40 years of age) patients are treated more intensively than older patients~     (older than 40 years of age), the investigational questions concerning blinatumomab can be~     examined in both subgroups as both younger and older patients receive the same type of~     chemotherapy courses with dose adjustments for chemotherapeutic agents only for patients~     above 60 years of age.~   "
1969|NCT03541070|"~     Investigators investigated that the effects of kinesilogy taping on balance in patients with~     Duchenne Muscular Dystrophy~   "
1970|NCT03541057|"~     The aim of this Register Trial is to systematically study the epidemiology, risk factors,~     liver function as well prognosis of patients with vascular liver diseases. Furthermore,~     important clinical parameters will be assessed in order to evaluate patients' coagulation~     status and in order to develop new biomarkers derived from blood, urine, stool or ascites of~     patients as well as histological samples from the upper / lower GI-tract or the liver in~     order to better understand the natural history of vascular liver diseases.~   "
1971|NCT03541044|"~     This study will assess the bioequivalence of the test product (Nicotine Prototype Mini~     lozenge 2 milligrams [mg]) to a commercial reference product (nicotine polacrilex mini~     lozenge 2 mg) in healthy smokers under fasting conditions.~   "
1972|NCT03541031|"~     The purpose of the trial is to determine whether a 36-ingredient Micronutrient supplement~     (primarily vitamins and minerals) and Fish oil (omega-3 fatty acid) supplement improves~     nutritional status and allows lower doses of conventional medications to be effective for~     bipolar disorder with fewer side effects, when studied under randomized and fully blinded~     conditions and compared to a placebo. All participants must live in the vicinity of Bangor,~     Maine.~   "
1973|NCT03541018|"~     To investigate which treatment option (reposition maneuver) with the TRV chair that is the~     most effective in patients diagnosed with benign paroxysmal positional vertigo (BPPV).~     Subtypes of BPPV will be examined after randomization to specific treatments.~   "
1974|NCT03541005|"~     -  Obesity is an important and growing worldwide~        -  Obesity is highly related to the development of metabolic syndrome, diabetes,~          cardiovascular diseases and cancer~        -  Diverse adverse events have been reported with the use of antiobesity drugs.~        -  Several articles describe the beneficial effect of several specific components of the~          Obex® supplement on weight loss, in the reduction of waist circumference, suppression of~          appetite, decrease fasting glucose levels, improvement of insulin sensitivity and β~          cells function.~        -  Therefore, the administration of Obex in overweight and obese patients could be an~          excellent strategy to induce weight loss and ameliorate the metabolic disturbances~          related to obesity and overweight.~   "
1975|NCT03540992|"~     This study is a registry study to examine the clinical features, blood pressure control rate,~     and clinical prognosis of resistant hypertension in Koreans. This study will register~     patients with resistance hypertension in eight tertiary hospitals in Korea and follow up them~     for three years. The prognosis will be analysed according to etiologies, achieved blood~     pressure, and types of antihypertensive medication.~   "
1976|NCT03540979|"~     Comparison of protocols for frozen embryo transfer (ET): One protocol using Estrogen~     supplements and the second protocol using Letrozole~   "
1977|NCT03540966|"~     Vitiligo is a common depigmented skin disease characterized by destruction of functional~     melanocyte.The recent therapies to vitiligo are including oral or external glucocorticoids,~     antioxidants, calcineurin inhibitors or phototherapy. However, long treatment period and~     unsatisfactory curative effects still exist, which confer long-term psychological burden to~     patients. As above concerns, it is of great value to explore therapeutic methods that can~     effectively control disease, improve appearance, relieve patients' pain and improve their~     quality of life. Current problem is the lack of a vitiligo life quality evaluation scale with~     Chinese characteristics for us. Therefore, it is necessary for the investigator to compile a~     vitiligo quality of life scale that is simple, feasible and applicable to China's national~     conditions. Meanwhile the reliability analysis must be carried out to bring better quality of~     life assessment tools to patients with vitiligo in China. Previous studies recommended that~     CapulinTM showing a good cover effect on vitiligo, but the effects of camouflage on the QoL~     of patients with vitiligo in Chinese population is unknown. Thus, the investigators undergo a~     randomized open-label controlled study to estimate the effects of CapulinTM on QoL of~     patients with vitiligo.~   "
1978|NCT03540953|"~     Management of pharyngoesophageal stenosis (PES) in patients after head and neck cancer (HNC)~     treatment remains a challenge. There are some cases of strictures refractory to dilation~     sessions. This study aimed to evaluate the efficacy of Mitomycin C (MMC) endoscopic injection~     for the treatment of refractory pharyngoesophageal stenosis.~      Patients and methods: This is a prospective study in patients with dysphagia following head~     and neck cancer treatment, without evidence suggestive of tumor recurrence, and refractory to~     endoscopic treatment. Theses undergo endoscopic dilation of the stenotic segment with~     thermoplastic bougies, followed by the injection of MMC.~   "
1979|NCT03540940|"~     Positive end-expiratory pressure (PEEP) applied during induction of anesthesia prevents~     atelectasis formation and increases the duration of nonhypoxic apnea in obese and nonobese~     patients. PEEP also prevents atelectasis formation in pediatric patients. Because pediatric~     patients arterial desaturation during induction of anesthesia develops rapidly, we studied~     the clinical benefit of PEEP applied during anesthesia induction.~   "
2999|NCT03527615|"~     Initiative to improve direct anticoagulant utilization involving programmatic review by~     clinical pharmacists in collaboration with multidisciplinary team.~   "
1980|NCT03540927|"~     Conflict and unrest over three decades has resulted in significant economic decline in Khyber~     Pakhtunkhwa (KP) and Federally Administered Tribal Areas (FATA) of Pakistan and these now~     rank among the poorest regions in the country. The 2009-10 insurgency and subsequent security~     operations affected both regions and displaced an estimated 2 million people. The severe~     damage to infrastructure and livelihoods negatively impacted the social and economic fabric~     of the entire region. As peace has returned to the area, the Economic Revitalization of KP~     and FATA (ERKF) project, established in 2012 and supported by the World Bank, is working for~     the rehabilitation of small and medium enterprises (SMEs), with the aim of creation and~     restoration of jobs. This support is in the form of grants given to individuals who use the~     funds to establish and run a business in their locality.~      Epidemiological studies from the area have shown high rates of common mental disorder (eg.,~     depression, anxiety) in the general population (Husain et al, 2006, Khan et al 2016). Such~     conditions have a serious impact on the well-being, functioning and productivity of affected~     individuals (World Health Organization, 2000). For example, in the USA, Depressive Disorders~     have been estimated to cost the economy over US$210 billion per annum, largely due to reduced~     productivity (Greenberg et al, 2015). The economic rehabilitation of a population exposed to~     a humanitarian crisis, and therefore at greater risk of depression, must include~     interventions to reduce mental morbidity so the individuals are able to function better and~     potentially improve their long-term productivity.~      The Human Development Research Foundation, in collaboration with the World Bank, has adapted~     a 5-session group intervention from WHO Problem Management Plus program, tailored to the~     needs of small and medium enterprise owners affected by the prolonged conflict in KP and FATA~     areas of Pakistan. This intervention (Problem Management Plus adapted for entrepreneurs) is~     based on established cognitive behavioral strategies previously tested in Pakistan (Rahman et~     al, 2016). The goal of the intervention is to improve psychological capital,reduce~     psychosocial distress leading to, increased productivity in the long-term. The intervention~     will be evaluated using a two arm, single blind randomized controlled trial.~   "
1981|NCT03540914|"~     Randomized, placebo controlled trial evaluating efficacy of acetazolamide on right heart~     function at rest in lowlanders older than 40 years travelling from 760 m to 3'100 m.~   "
1982|NCT03540901|"~     This trial will evaluate the effect of acetazolamide (375 mg per day) vs. placebo on lung~     water content by ultrasound at acute altitude exposure in patients with Chronic Obstructive~     Pulmonary Disease (COPD).~   "
1983|NCT03540888|"~     Flexibility, agility and muscle strength are key factors to either win or lose a game.~     Recently the effect of a new technique, deep transverse friction massage (DTFM), on muscle~     extensibility, strength and agility and injury occurrence has been examined, as compared to~     traditional stretching techniques.~   "
1984|NCT03540875|"~     This study compares automated administration of propofol and remifentanil versus manual~     administration during general anesthesia for a surgery. The closed-loop coadministration of~     propofol and remifentanil is guided by qCon and qNox indexes from the Conox monitor.~   "
1985|NCT03540862|"~     Chronic obstructive pulmonary disease (COPD) is characterized by irreversible airflow~     obstruction with chronic airway inflammation and emphysematous changes in the lung~     parenchyma, thus leading to air-trapping, as well as extional dyspnea. We have previously~     observed that NPV used as an adjuvant to pulmonary rehabilitation improves lung function,~     exercise capacity, and reduces exacerbations. We now sought to determine whether long-term~     maintenance NPV improves long-term clinical outcomes and reduces mortality in COPD.~   "
1986|NCT03540849|"~     Despite a high recovery rate with chemotherapy and radiation therapy treatment, 15 to 30% of~     patients suffering from Hodgkin lymphoma are refractory or relapsed. Standard rescue~     treatment for these patients is chemotherapy followed by a hematopoietic stem cell auto-SCT.~     Despite a very good rate of complete sustainable response in 50% of the patients, another 50%~     of the patients relapse after increased therapy and require additional treatment.~     Consequently, one option for these patients is to offer a novel rescue therapy, enabling them~     to have partial or complete response, and offer them a hematopoietic stem cell allo-SCT. In~     the only prospective phase 2 study published by Sureda et al. assessing this therapeutic~     approach, the rate of mortality not linked to relapse was 8% at 100 days and 15% at 1 year.~     The progression-free survival rate was 48% at 1 year and 24% at 4 years. Relapse occurred~     between 3 and 35 months with a median of 6 months in 51% of the patients out of a total of 78~     patients. Cumulative incidence of relapse was 37% at 1 year and 59% at 5 years.~      Brentuximab Vedotin (Bv) is an anti-CD30 antibody-drug conjugate. This drug has shown its~     efficacy with very acceptable toxicity in patients suffering from advanced-stage Hodgkin~     lymphoma. Bv was consolidatively evaluated after an auto-SCT. 329 patients, at high risk of~     relapse after auto-SCT, received Bv (n=165) in a dose of 1.8 mg/kg every 3 weeks or a placebo~     (n=164) for 16 cycles. The progression-free survival median (validated by a panel of~     independent experts) was 42.9 months (95% CI 30,4-42 ; 9) for patients in the Bv group and~     24.1 months (11.5 not reached) in the placebo group.~      The purpose of our study is to reduce relapse rate by carrying out maintenance with Bv after~     allografting hematopoietic stem cells in a population of patients suffering from Hodgkin~     lymphoma with high risk of relapse after auto-SCT. Fifty eight patients have been slated for~     inclusion over a period of 2 years.~      This is an open-label, prospective, multicenter, phase II trial consisting of post allo-SCT~     maintenance Bv for Hodgkin lymphoma.~      Patients will be recruited over 24 months and be followed for 3 years after allo-SCT.~      A total of 58 patients will be included in the study. The duration of the treatment period is~     approximately 10.7 months for 12 cycles of Bv.~      End of study: end of study is defined by the last visit planned by the protocol of the last~     patient in follow-up, which means 3 years after allo-SCT.~   "
1987|NCT03540836|"~     This is an open-label, randomized, 3 treatment, 3-period, 6-sequence, crossover study~     conducted at a single study center to characterize the relative bioavailability of~     relacorilant administered as 3×100-mg softgel capsules (Treatment A), 3×100 mg hard-shell~     capsules (Treatment B), and 6×50-mg hard shell capsules (Treatment C/reference) in healthy,~     fasted, adult subjects.~      Eligible subjects will participate in 3 treatment periods. During each treatment period,~     subjects will receive a single 300-mg relacorilant dose. An equal number of subjects will be~     randomized to each of 6 sequences.~   "
1988|NCT03540823|"~     Studies in the literature have shown reduced effectiveness of influenza A (H3N2) virus~     vaccine (20-40%) when compared to A (H1N1) and influenza B. This reduction in efficacy may~     partly result of the need to propagate A (H3N2) virus into egg components for the preparation~     of the vaccine. Other factors that may also contribute to the reduction of efficacy against A~     (H3N2) viruses include the high level of genetic diversity and the rate of rapid evolution of~     this particular virus subtype and the modification of the immune response to the vaccine~     secondary of prior infection or vaccination.~      Vaccine efficacy studies are required to verify the immunogenicity of the H3N2 influenza~     vaccine in immunosuppressed patients with rheumatologic disease. In addition, it is relevant~     to evaluate the safety of the vaccine in this population as well as the possibility of~     reactivation of the rheumatologic disease itself. The objectives of this study are to~     evaluate the immunogenicity of the H3N2 component of the inactivated and fragmented influenza~     vaccine in patients with two systemic autoimmune rheumatic diseases (Systemic Lupus~     Erythematosus - Adult and Juvenile, Primary Sjögren's Syndrome).~   "
2028|NCT03540290|"~     To test the modification of the implant prosthesis, in order to facilitate access to biofilm~     control, in combination with decontamination of the implant surface by means of an ultrasonic~     device with a plastic tip and plastic curettes, in comparison with the decontamination of the~     implant surface by means of an ultrasonic device with a plastic tip and plastic curettes, and~     no modification of the implant prosthesis.~   "
3000|NCT03527602|"~     The purpose of this study is to determine whether enlarging the apical foramen causes~     postoperative pain in anterior teeth with necrotic pulp and apical periodontitis.~   "
1989|NCT03540810|"~     Antiphospholipid syndrome (APS) combines thrombotic (venous and/or arterial) and/or~     obstetrical manifestations, along with biological anomalies related to the presence of~     antiphospholipid antibodies. Despite actual treatment recommended by international~     guidelines, the relapse rate in APS is high and survival is 65% at 15 years.~     Hydroxychloroquine has demonstrated its efficacy and benefits in the treatment of Systemic~     Lupus Erythematosus, but there is no current consensus concerning the efficacy of this~     treatment in the secondary prevention of thrombotic events in primary APS, even though~     several in vitro experimental and animal model data, along with several clinical studies have~     suggested a beneficial effect of this drug in this indication. Considering the prevalence of~     primary APS in the general population and of the number of clinical events observed in~     patients with primary APS and receiving conventional treatment with vitamin K anticoagulants~     (VKA), the consortium expects a minimum clinically relevant difference of 70%. Considering a~     prevalence of thrombotic events for the entire studied primary APS population of 10% at 2~     years, the consortium expects a 70% decrease in thrombotic events under Hydroxychloroquine~     treatment administered in addition to VKA treatment in primary APS, i.e. a 3% prevalence in~     the Hydroxychloroquine group at 2 years. The consortium proposes a drug trial, phase III,~     national multicentric, comparative, randomized, superiority, double-blind, controlled with 2~     compared groups (Hydroxychloroquine versus placebo) study. The enrolment period will be 24~     months.~      The main aim of this trial is to comparatively assess at 24 months the number of new~     thrombotic events (venous and arterial) in primary antiphospholipid syndrome in patients~     treated with VKA plus Hydroxychloroquine versus VKA plus placebo, in a multicentre,~     prospective randomized, double-blind, versus placebo study.~   "
1990|NCT03540797|"~     This study is designed for septic patients, to isolate MDSCs and the correlation of prognosis~     of sepsis. The purpose of this study hopes to explore the phenomenon and possible mechanisms~     of MDSCs in patients with severe sepsis.~   "
1991|NCT03540784|"~     Patients with inflammatory bowel disease (IBD) often suffer from muscle weakness and a low~     bone mineral density as a consequence of systemic Inflammation and disease treatment limiting~     Quality of life in a considerable way. Exercise interventions to build up muscle mass and~     increasing physical function are promising Tools to improve the whole muscular Status of~     those patients. However, in the acute Phase of IBDs conventional Training methods may be too~     strenous, also because patients are suffering from acute gastrointestinal symptoms and feel~     fatigued. Due to those symptoms, patients present low Food intake and great loss of nutrients~     and energy especially by diarrhea. Individualized nutritional Support may be helpful to avoid~     malnutrition. The aim of this pilot study is to investigate the effect of a combined exercise~     and Nutrition Intervention using the gentle Training method of whole-body~     electromyostimulation (WB-EMS) combined with a individual high Protein nutritional Support on~     muscle mass, Body composition, physical function, Quality of life and gastrointestinal~     symptoms in outpatients with IBD.~   "
1992|NCT03540771|"~     This is a comparative effectiveness study of two pragmatic models aiming to introduce~     palliative care in care for end stage liver disease patients. The 2 comparators are:~      Model 1: Consultative Palliative Care (i.e. direct access to Palliative Care provider), Model~     2: Trained Hepatologist- led PC intervention (i.e. a hepatologist will receive formal~     training to deliver Palliative Care services)~      Primary Outcome: The change in quality of life from baseline to 3 months post enrollment as~     assessed by FACT-Hep (Functional Assessment of Cancer Therapy- Hepatobiliary).~      14 Clinical Centers across US are recruited to participate in this study.~   "
1993|NCT03540758|"~     The goal of this study is to understand how activating control centers of the brain with~     diazoxide can affect how much glucose (sugar) is produced by the liver. This is particularly~     important for people with diabetes who have very high production of glucose, since this could~     be at least in part due to impaired regulation of the liver by the brain.~   "
1994|NCT03540745|"~     The purpose of this research study is to determine whether Nexalin Trans-cranial Electrical~     Stimulation (TES) is a viable adjunctive treatment of substance use treatments.~   "
1995|NCT03540732|"~     The aim of this study is to evaluate the effect of early exercise by cycle ergometry and~     early targeted feeding in reducing muscle atrophy and improve functional outcomes in the~     older critically ill patient.~   "
1996|NCT03540719|"~     This protocol concerns an academic, multicentric, and prospective clinical trial. In this~     study the investigators will evaluate the recently approved WAVE-plate (7S Medical) for open~     reduction and internal fixation and buttressing of the posterior proximal tibial column via a~     posteromedial reversed L-shaped approach. The reversed L-shaped approach has been shown as a~     safe technique with adequate visualisation of the posterior tibial surface. The investigators~     will thoroughly evaluate all important clinical, radiological and functional variables. The~     functional outcome will be reported in patient reported outcome measures by means of the~     validated Knee injury and Osteoarthritis Outcome Score (KOOS).~   "
1997|NCT03540706|"~     Respiratory infections, including episodes of coughing with fever, are the leading cause of~     outpatient antibiotic prescription, while a minority of them are linked to bacterial~     infections requiring antibiotic. These prescriptions are often performed by general~     practitioners who see children and adults. These unnecessary antibiotic contribute to~     increased bacterial resistance, side effects and unnecessary costs. The campaigns of good use~     of antibiotic associated with the use of diagnostic tests have had a real but partial and /~     or transient success. Pneumonias are more common in patients with weak antibiotic prescribers~     (highlighting the difficulty of diagnosing bacterial pneumonia among respiratory infections)~     (1). Point-of-care tests such as the C-reactive protein micro-method (POCT-CRP) have been~     developed to help differentiate between viral and bacterial infections and thus contribute to~     the proper use of antibiotics. The decrease in prescription of antibiotics is likely to have~     an even stronger positive impact in countries like France, where prescription is high. The~     impact of this type of intervention is variable and depends on many factors, such as the~     training of doctors, their prescribing habits, the socio-economic level of populations~     treated and the national culture in terms of use of antibiotics.~   "
2022|NCT03540368|"~     Studies showed that in cases of gastrointestinal bleeding, injection tranexamic acid~     decreasing the risk of death and the need of surgical intervention. However, the quality of~     most clinical trials were not good and the results were not significant. Injection tranexamic~     acid does not become one of the treatment option in the international guidelines nor in~     national consensus, so the effectiveness and the safety of its use in the treatment of~     gastrointestinal bleeding remains unclear and not routinely used.~      In Indonesia, injection tranexamic acid in gastrointestinal bleeding is limitedly used and~     recorded. Therefore, a clinical trial study of injection tranexamic acid is required to~     assess the effectiveness and the safety in the treatment of gastrointestinal bleeding.~   "
2023|NCT03540355|"~     The purpose of this study is to evaluate the efficacy of Cipros 20 association in the~     treatment of dyslipidemia treatment.~   "
6327|NCT03484026|"~     This study evaluates the safety, tolerability, and activity of BioFe in the dietary~     management of iron deficiency in adults.~   "
1998|NCT03540693|"~     Fat is the most energy dense macronutrient and consuming fat has been positively correlated~     to obesity. Individuals afflicted with obesity crave fat more frequently, have a higher~     preference for fatty taste, and consume a higher quantity of fatty foods. People who have~     undergone Roux-en-Y Gastric Bypass (RYGB) or Sleeve Gastrectomy (SG) weight-loss surgeries~     dramatically decrease their fat preferences and consumption of fat, at least within the first~     year after surgery. These surgeries are very effective in helping people lose weight over the~     first couple of years; however, approximately 30% of those who undergo these surgeries start~     regaining weight after the second year mark. Why some people are able to keep the weight off~     long-term but others are unable to is unclear. In addition, it is well-known that fat can~     modify the flavor of foods and flavor plays a critical role in consumption, as well as in~     responses that gear up the body to consume the food. These are known as cephalic phase~     responses and include neural, physiological, and hormonal aspects. The main goals of the~     study are twofold: 1) To test the immediate effects of RYGB surgery, SG surgery, and~     laparoscopic gastric banding (LAGB) surgery (a weight loss control group) on fat preferences,~     sensory perception, and cephalic phase responses and 2) to compare fat preferences, sensory~     perception, and cephalic phase responses between those who are able to achieve sustained~     weight loss 2-5 years after RYGB or SG surgery and those who either regained weight or did~     not lose the desired amount.~   "
1999|NCT03540680|"~     The bronchopulmonary dysplasia (BPD) is a respiratory disease of the premature child which~     lead to a reduction of gas exchange surface and to a prolonged respiratory failure. This~     disease has morphologic and functional consequences at adulthood and is today considered to~     be an early determinant of respiratory diseases at adulthood.~      The physiopathology of BPD is not well known. Several mechanisms could be involved especially~     a reparation failure favored by an increase of cellular senescence which is a permanent stop~     of cellular proliferation. The transcription factor 16 Ink4a, considered as a marker of~     aging, is one of the essential markers of senescence. Its increase during prematurity was~     shown at the blood cells of the cordon, but its involvement in BPD and its evolution in child~     are not yet studied.~   "
2000|NCT03540667|"~     This multi-site, observational, prospective study aims to investigate current practice and~     associated outcomes for patients scheduled for elective unilateral total hip or knee~     arthroplasty in South Africa.This information will provide baseline values, against which~     effects of implementing a multidisciplinary enhanced care protocol for arthroplasty patients~     will be compared (the subsequent study).~   "
2001|NCT03540654|"~     Chronic myeloid leukemia (CML) is a model of targeted therapy for human malignancies. Over~     the past decade, a broad array of drugs designed to selectively inhibit protein tyrosine~     kinases (PTK) [i.e., tyrosine kinase inhibitors, (TKI)] have emerged as novel therapies for~     cancer patients. Hence, CML is an hematopoietic stem cell disorder in which a t(9;22)~     (q34;q11) reciprocal chromosomal translocation gives rise to Philadelphia chromosome (Ph) and~     generates the BCR-ABL1 fusion gene encoding a constitutively activated PTK. TKIs, such as~     imatinib by blocking BCR-ABL1 kinase activity, selectively eradicate CML cells and induce~     durable responses and prolong survival. CML patients treated with TKI are monitored by~     quantitative RT-PCR to detect leukemic BCR-ABL1 transcript performed from peripheral blood~     samples (1).~      Since TKI treated CML patients have a near-normal life expectancy two important issues must~     be considered in the future:~        1. the quality of life and ethical aspects of a lifetime treatment,~        2. the budget impact for healthcare providers of treating patients during lifetime.~      One of the best ways to consider these two points is to ask the question about stopping TKI~     in good responder patients. We first reported a pilot study where imatinib was withdrawn in~     12 CML patients treated and maintained in complete molecular remission (CMR), defined by~     undetectable residual disease (with sensitivity of 4.5 log) on quantitative RT-PCR, for at~     least two years. Then, we demonstrated in a multicenter study entitled STIM trial that~     imatinib could be safely discontinued in patients with CMR for at least 2 years (2). All~     molecular relapsing patients were sensitive when imatinib was re-challenged (3). Around 40%~     of these patients remain in a prolonged treatment-free remission (TFR) after treatment~     cessation (4). Taking into account the cost of imatinib and the number of months without~     treatment in STIM trial, the savings in France were estimated to be 9 million €. However,~     since only 40 % of patients are in treatment free remission, a study, assessing the real~     budget impact of stopping TKI in the eligible population seems necessary as no published~     study has ever addressed this question in France.~      Our aim is to assess the budget impact of discontinuing TKI treatment in patients with CML in~     deep molecular response since at least two years, compared with treatment during lifetime,~     from the French healthcare system point of view. This budget impact will be expressed as a~     net benefit and will be based on the difference between total costs incurred by this~     strategy and total costs avoided also.~      One of the originality of our study is to raise the issue of treatment cessation in the~     context of a chronic disease from an economic point of view.~      The other originality of this study is to use a decision model to perform this French budget~     impact analysis of TKI discontinuation, without setting up another trial. Besides the~     literature review and meta-analysis; the proposed probabilistic Markov model will use direct~     costs (including treatment costs and all health care related costs as well as costs related~     to relapse) extracted mainly from the French Health Insurance Databases.~   "
2002|NCT03540641|"~     This study evaluates de efficacy of 5Hz repetitive Transcranial Magnetic Stimulation (rTMS)~     applied on the left dorsolateral prefrontal cortex in patients with binge eating disorder.~   "
2003|NCT03540628|"~     The purpose of this research study is to determine whether patients who receive thiamine~     (vitamin B1), vitamin C and hydrocortisone while in septic shock have improved outcomes~     compared to hydrocortisone alone.~      A recently published article Hydrocortisone, Vitamin C and Thiamine for the treatment of~     Severe Sepsis and Septic Shock, suggested substantial mortality reduction (78%). We wish to~     test the hypothesis that mortality reduction is at least 25% in a prospective randomized~     trial. Other important sub-aims include the testing whether the protocol reduces the time on~     pressors agents, reduces the trajectory of the SOFA score, or reduces the trajectory of~     procalcitonin.~   "
2004|NCT03540615|"~     The primary objectives of this study are to investigate~        -  the safety and tolerability of increasing single oral doses of BAY 1830839 versus~          placebo under fasted conditions~        -  the pharmacokinetics after single ascending oral doses of BAY 1830839 under fasted~          conditions~   "
2005|NCT03540602|"~     Strength training is commonly used as an intervention to increase muscle mass, thus improving~     a person's ability to undertake activities of daily living, or enhance athletic performance.~     The strength training regimen itself, while ultimately having beneficial effects, causes~     muscle fibers to be damaged, which the body has to recover from. As the body recovers, it~     rebuilds the muscle tissue and after multiple consecutive bouts of strength training, the~     muscle eventually becomes larger and stronger. Thus, it is the recovery from strength~     training exercise that ultimately determines how well the body adapts. Where inadequate~     recovery could eventually lead to overtraining and/or injury, optimizing the recovery process~     from strength training could maximize strength training adaptations. This concept of~     optimizing recovery has led to development of many supplements, including antioxidants, which~     may reduce the damage associated with strength training activities and therefore enhance~     positive adaptations. The purpose of this study is to assess the ability of a polyphenol rich~     supplementation to aid the recovery process from a demanding bout of resistance exercise~   "
2006|NCT03540589|"~     Vaccine pain control is one of the actions suggested to support the delivery of vaccines that~     are on a vaccine schedule, since pain and anxiety associated with vaccines are among the main~     reasons why children and their parents fail to do them properly. Thus, it is very important~     to investigate which interventions can bring greater benefit in the control of pain.This is a~     randomized clinical trial aiming to assess the impact of video distraction and vibration~     device on pain during the vaccination of children between one and three years.~   "
2007|NCT03540563|"~     Tumours continually shed DNA into the circulation, where it can be accessed. This circulating~     tumour DNA (ctDNA) directly reflects tumour burden and has great potential to be a sensitive~     biomarker for treatment recurrence. These liquid biopsies could give a more real-time~     picture of the genomic status and evolution of a tumour and can be easily assessed for~     measurement of different biomarkers. However, in head and neck squamous cell carcinoma~     (HNSCC) patients treated with primary curative radiotherapy, data regarding ctDNA kinetics~     and its correlation with outcome are scarce. A new or additional tool for response evaluation~     next to or instead of conventional imaging after treatment would be beneficial to detect~     recurrences in an earlier stage, thereby increasing the chances of success of salvage~     therapy. More importantly, an early response parameter during treatment could help to~     identify patients that have a good treatment response and might benefit from treatment~     adaptation. With this study, we aim to reveal ctDNA as an effective tool for future dose~     (de)-escalation trials in HNSCC.~   "
2343|NCT03536169|"~     The purpose of this study is to investigate course of illness leading to reoperation after~     primary anti-reflux surgery and investigate the utilization of anti-reflux treatment, both~     medical and surgical, in the period 2000-2017~   "
2009|NCT03540537|"~     Pain after hepatectomy can interfere with the patients' recovery and may contribute to~     developing long term pain. Opioids, e.g. morphine, fentanyl, sufentanil, works well for~     postoperative analgesia, but have several side effects such as nausea, vomiting and itching~     which may be severe enough to affect patients' recovery. In some cases, opioids may cause~     constipation and uroschesis within the first 24 hours after surgery. Thus, several~     ultrasound-guided nerve block procedures have been applied to provide postoperative~     analgesia. Ultrasound-guided thoracic paravertebral block (TPVB) is one of the most used~     nerve block methods using for post-hepatectomy analgesia. However, in some cases,~     ultrasound-guided TPVB can cause pneumothorax, hemopneumothorax, and higher block level. The~     quadratus lumborum block (QLB) is a new developed nerve block which can provide a widespread~     analgesic effect from T7 to L1. Therefore, this study is to determine whether QLB or TPVB~     have a better pain control with fewer side effects and complications after laparoscopic and~     open hepatectomy. The adequate pain control will be assessed by their visual analogue score~     (VAS) and the postoperative quality of recovery scale (QoR-15, Chinese Version).~     Additionally, the side effect and complications profile of these two nerve block techniques~     will also be recorded and compared.~   "
2010|NCT03540524|"~     This is a Phase Ib, multi-center, open-label, nonrandomized multiple cohorts study to assess~     the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of a~     combination treatment of GLPG2451 and GLPG2222, with and without GLPG2737, in adult subjects~     with Cystic Fibrosis.~   "
2011|NCT03540511|"~     Elevated level of troponin is frequently observed among patients with renal dysfunction.~     Increase in troponin after cardiac surgery may predict postoperative outcome in cardiac~     surgery patients. However, the relationship between the increased troponin and outcome after~     cardiac surgery has not been fully elucidated in patients with renal dysfunction.~   "
2012|NCT03540498|"~     Study will follow a randomized, double-blind, split-mouth, placebo-controlled design with two~     groups in parallel,N of 40 patients in 60 days of follow up for the evaluation of two~     different posology models (daily consumption of probiotic gum, with or without previous~     professional oral cleaning). Probiotics have recently been used to combat oral diseases~     (plaque control, caries, halitosis, etc.), as a non-invasive natural therapy.~   "
2013|NCT03540485|"~     Phase I / II randomized, single-blind, placebo-controlled clinical trial to evaluate the~     safety and efficacy of melatonin administration in patients with Progressive Multiple Primary~     Sclerosis.~   "
2014|NCT03540472|"~     Pure red cell aplasia (PRCA) is a kind of anemia characterized by severe reticulocytopenia~     and obvious bone marrow erythroblastic cells decreased. Cyclosporine and /or steroids are the~     first line therapy but some patients were refractory or intolerance to the treatment. The~     effects of the second line therapy are also not satisfactory and sometimes not available. The~     investigators aim to explore the efficacy and side-effect of tacrolimus for refractory PRCA.~   "
2015|NCT03540459|"~     all patients with a left ventricular ejection fraction superior or equal to 50% less than 2~     years after an acute coronary event and receiving ticagrelor will undergo a sleep polygraphy~   "
2016|NCT03540446|"~     To prove the effectiveness of Percutaneous Electrical Neuro-stimulation therapy for the~     treatment of conditions associated with peripheral neuropathy, in a double-blind environment.~   "
2017|NCT03540433|"~     The purpose of this international, multi-centre observational study is to describe~     perioperative cognitive changes (pre-existing neurocognitive disorder [NCD], postoperative~     delirium [POD] and Postoperative Cognitive Dysfunction [POCD]) up to five years after~     elective surgery in a mixed cohort. Measurements and definitions of cognitive outcomes will~     be based on current consensus and used for further harmonization in future clinical studies~     on perioperative cognitive trajectories. This is a feasibility approach to identify an~     effective screening procedure and estimate loss to follow up rates for the planning of future~     intervention studies. Data from this trial may also serve to facilitate and implement time~     effective cognitive screening and risk stratification concerning postoperative cognitive~     decline in the anaesthesiological preoperative assessment.~   "
2018|NCT03540420|"~     Some patients with limited disease small-cell lung cancer (LD SCLC) are cured after~     chemo-radiotherapy, but the majority relapse and die from their cancer. Better therapy is~     needed. Immunotherapy represents the largest advance in cancer therapy in recent years and~     has demonstrated promising activity in SCLC. In this study we will investigate whether~     atezolizumab prolongs survival in LD SCLC patients who have undergone chemo-radiotherapy.~   "
2019|NCT03540407|"~     The purpose of this study is to evaluate the efficacy of oral solution Oncoxin-Viusid in the~     reduction of acute toxicity of Radiotherapy (RTP) and Chemotherapy (QTP) in patients with~     histological diagnosis of cervical cancer and endometrial adenocarcinoma. This is a phase II,~     prospective, randomized and double blind clinical trial, which will include 66 patients~     assigned to 2 treatment arms: 33 patients will receive conventional treatment, plus a placebo~     of the nutritional supplement and another 33 patients will receive along with the~     conventional treatment the Oncoxin-Viusid nutritional supplement produced by the Catalysis~     Laboratories of Spain. Patients will receive oral treatment throughout the onco-specific~     treatment and up to 3 weeks after completion.~   "
2020|NCT03540394|"~     The goal of this study is to review the etiology, diagnostic criteria, complications and~     outcome of acute pediatric compartment syndrome identified at The Children's Hospital of~     Western Ontario (CHWO) . Follow up with patients treated for compartment syndrome by~     fasciotomy will assist in determining the long term effects of compartment syndrome and~     surgical procedures on the patient quality of life and return to level of function of the~     affected limb.~   "
2021|NCT03540381|"~     The aim of this study is to evaluate the relation among cholesterol uptake capacity which~     measure HDL functionality, neoathrosclerosis and target-lesion revascularization.~   "
2024|NCT03540342|"~     The study is designed to evaluate the safety and effectiveness of the one-stop endovascular~     intervention strategy for patients with concomitant coronary artery disease and aortic~     atherosclerotic disease. It is a registration study, which will consecutively enroll at least~     50 patients with at least 30 subjects receiving one-stop strategy.~   "
2025|NCT03540329|"~     Distraction osteogenesis is a powerful technique for creating new bone during significant~     lengthening of the mandible without the need for bone grafting and associated donor site~     morbidity.~      The idea of distraction osteogenesis was largely abandoned by many until the 1950s. Ilizarov~     minimized complications by performing a corticotomy with minimal disruption of the~     surrounding blood supply and using a system of tension ring fixators to control the~     distraction in multiple planes. Through a series of experimental studies and clinical~     applications, Ilizarov established the foundation of distraction osteogenesis and its role in~     orthopedic management.~      Applications in craniofacial surgery were first seen in 1973, when Synder et al applied the~     approach to mandibular lengthening in a canine animal model. Almost another 20 years passed~     before McCarthy and colleagues published, in 1992, the first report of mandibular lengthening~     in 4 children with congenital mandibular deficiency, 3 with hemifacial microsomia, and 1 with~     Nager syndrome. Thereafter, its role rapidly expanded to the midface and nearly all classic~     approaches to craniofacial reconstruction.~      In general, mandibular distraction can be performed in the ramus for ramus lengthening, in~     the mandibular angle for downward and forward advancement, or in the mandibular body. Ramus~     or gonial angle distraction are mainly used to treat facial asymmetries as in hemifacial~     macrosomia.~      Severe mandibular retrognathia can be classified as congenital or acquired. Congenital~     abnormalities that are associated with severe mandibular retrognathia or micrognathia include~     craniofacial syndromes such as hemifacial microsomia, Pierre-Robin syndrome, Treacher-Collins~     syndrome, and Nager syndrome. Adult patients with craniofacial syndromes may have undergone~     previous surgery at an earlier age, but unfavorable postsurgical growth or skeletal relapse~     may have occurred.~      Severe mandibular retrognathia also can develop following maxillofacial trauma and mandibular~     fractures, which may have occurred in an adult or as a child Condylar fractures occurring at~     an early age can result in subsequent bony and/or fibrous temporomandibular joint ankylosis~     and/or deficient mandibular growth, also adult patients with complications from previous~     mandibular tumor resection and reconstruction can also present with acquired severe~     mandibular retrognathia that may require distraction osteogenesis as well.~      Despite the advantages of extra-oral distraction devices in the hands of clinicians~     (application for very small children, simplicity of attachment, ease of manipulation,~     bidirectional and multidirectional dis- traction), patients are apprehensive about wearing~     bulky external appliances because of the social inconvenience and the potential of permanent~     facial scars, these disadvantages and limitations were the primary force driving the~     evolution of mandibular lengthening and widening toward the development of intra-oral~     devices.~      However nowadays both internal and external distractors are used in a variety of indications~     in these cases each of the two types of distractor devices has its own advantages and~     disadvantages.~      Aim of the work:~      The aim of this study is to compare external and internal distraction devices for mandibular~     lengthening in terms of bone lengthening, patient comfort, and complications.~   "
2432|NCT03534999|"~     Fifty patients with hip arthroplasty were purposively recruited for the study. They were~     allocated into two groups randomly with equal number. One group had TEN, other served as~     control. Pain intensity was measured every day of the treatment.~   "
2029|NCT03540277|"~     Cluster-Randomized Clinical trial, which includes the development and activation of an~     intervention program among young adolescents and their parents. Study hypothesis is that the~     intervention program will yield improvement in adolescents whose parents participated in the~     program, in comparison with the adolescents whose parents weren't involved in the~     intervention. Results will be measured using the study questionnaire, to be filled out by the~     participants before, after, and three months after the completion of the program. The~     questionnaire will include validated questionnaires with good psychometric qualities. The~     study protocol was approved by Tel Hai College institutional review board. Parents of all~     participants, in the intervention and in the control group, received information about the~     program and the study and were asked to provide informed consent.~   "
2030|NCT03540264|"~     Tooth wear is a physiological process occurring from normal functioning of the dentition~     throughout lifetime.~      The studies in the current literature indicated that both techniques of tooth preparation and~     the materials used are appropriate for the treatment of this condition, but the tendency is~     to reduce tooth preparation as reasonably possible. In this clinical trial, the investigators~     will compare the outcomes of direct resin composite and indirect~     polymer-infiltrated-ceramic-network.~   "
2031|NCT03540251|"~     Object:The aim of this study was to investigate the effectiveness of sticking and massaging~     auricular points for the management of hot flashes in postoperative breast cancer patients.~   "
2032|NCT03540238|"~     Most gastrointestinal endoscopic procedures are now performed with sedation and analgesia.~     Sedation and analgesia affects the quality of the procedure, patient co-operation and~     compliance as well as endoscopist's satisfaction. A wide variety of procedures have been~     reported worldwide for anesthesia during gastrointestinal endoscopy in adults.~      The current survey was primarily designed to provide national data on the attidutes and~     behaviors of gastroentorologist on anesthesia procedures in endoscopy units in Turkey.~   "
2033|NCT03540225|"~     This trial is a randomised, multi-centre, 2 x 2 factorial designed pilot trial with two~     factors of 200mg vs. 400mg progesterone self-administered daily from 11-14 weeks' gestation~     vs. 20-24 weeks' gestation, to compare the median gestational age (in days) at delivery~     between the comparison groups.~   "
2034|NCT03540212|"~     This is an interventional Phase II/III, single center, single arm clinical trial to assess~     the pharmacokinetics, efficacy, safety and tolerance of daclatasvir plus sofosbuvir in~     treatment-naïve, non-cirrhotic adolescents with chronic HCV GT-4 infection.~      A single-arm evaluation of daclatasvir/sofosbuvir will focus on the pharmacokinetics,~     efficacy and safety~      All enrolled patients will receive daclatasvir 60 mg orally once daily plus sofosbuvir at a~     dose of 400 mg orally once daily for 12 weeks.~   "
2035|NCT03540199|"~     This is a phase II Randomized comparison clinical trial of activated CIK armed with~     anti-CD3-MUC1 bispecific antibody for advanced kidney cancer. And the aim of this research is~     to study the clinical efficacy and safety of activated CIK armed with anti-CD3-MUC1~     bispecific antibody for kidney cancer.~   "
2036|NCT03540186|"~     The study evaluates analgesic, antiinflammatory and metabolic effects of a supplement~     Epigenome-Antivir (extracts of glycyrrhiza roots, hippophae rhamnoides leaves, curcumin,~     green tea, and vitamin C) combined with acupuncture in patients with knee osteoarthritis (OA)~     and metabolic syndrome.~   "
2037|NCT03540173|"~     Some patients felt no pain or only mild discomfort with the unsedated colonoscopy. However,~     unsedated colonoscopy was thought to be an option for some but not for all. If we could able~     to identify which patients at high risk for painful colonoscopy in preoperational stage,~     targeted administration of sedatives or special techniques to these patients would be an~     attractive option.~   "
2038|NCT03540160|"~     Study of the long term safety of serlopitant for the treatment of pruritus in adults.~   "
2039|NCT03540147|"~     The impact of blood flow restriction (BFR) on exercise and hemodynamic responses will be~     studied. The use of BFR will be studied during yoga and low-intensity aerobic exercise in~     healthy subjects with no history of chronic illness ranging from 18-40 years of age. This~     study will evaluate several conditions related to cardiovascular physiology in order to~     determine the safety and efficacy of this type of exercise training. First, the effects of~     two distinct types of BFR cuffs (BStrong and Hokanson) will be studied during low-intensity~     aerobic exercise on vascular function. Second, the effect of yoga will be studied with and~     without the use of BStrong bands on vascular function. Outcome measures include acute effects~     on endothelial function i.e. flow-mediated dilation, arterial stiffness, beat-by-beat blood~     pressure, heart rate, RPE (rate of perceived exertion), and blood lactate. For this~     intervention, the BFR cuffs will be used during exercise to evaluate its safety and efficacy.~     Since BFR is becoming a widely popular method of exercise, it is important to study its~     safety and hemodynamic effects.~   "
2040|NCT03540134|"~     This is an open-label, single-arm, pilot study investigating the safety and feasibility of~     infusion-enhanced, MRI-guided DBS electrode placement. The investigators intend to enroll~     patients with Parkinson's disease and medically-refractory motor symptoms, who are already~     planned for MRI-guided DBS electrodes under general anesthesia. The hypothesis of the study~     is that a convective micro-infusion of autologous CSF will enhance the T2-weighted MRI~     visualization of the targeted nucleus during image-guided DBS surgery for Parkinson's~     disease. The investigators will record standard clinical measures of PD at baseline and 6~     months following DBS surgery. The study will recruit patients at a rate of approximately one~     a month and will take less than two years to complete.~   "
2041|NCT03540121|"~     This study aims to test the effectiveness of an electronic-based video intervention and~     behavioral contract on improving medication adherence among kidney transplant recipients.~   "
2089|NCT03539497|"~     The aim of the study is to determine prognostic value of plasma mitochondrial DNA and~     cytochrome C after cardiac arrest.~      The study will be conducted in three parts:~        1. Determine plasma concentrations of mitochondrial DNA and cytochrome C in healthy~          population.~        2. Determine release profile of mitochondrial DNA and cytochrome C to plasma after cardiac~          arrest.~        3. Determine plasma prognostic value of mitochondrial DNA and cytochrome C after cardiac~          arrest and compare it with established prognostic methods.~   "
3001|NCT03527589|"~     Prostatic artery embolization with Embosphere Microspheres is a relatively new procedure. The~     goal of this post market study is to evaluate long-term safety and effectiveness in a 'real~     world' setting.~   "
2042|NCT03540108|"~     Coronary heart disease (CHD) is one of the major causes of death and disability in~     industrialised countries. Results from several epidemiological and clinical studies indicate~     a positive correlation between elevated total serum cholesterol levels, mainly reflecting the~     LDL-cholesterol fraction, and risk of CHD. It is thought that a reduction in total plasma~     cholesterol levels in populations suffering from primary hypercholesterolemia (elevated~     cholesterol) can lower the incidence of coronary thrombosis. Currently, therefore there is~     extensive interest in the management of serum cholesterol and other blood lipids. Diet is~     viewed as a major influencing factor that can reduce levels. This is largely driven by the~     expense of drug therapy, the large numbers of individuals affected and unwanted side effects~     of such treatments. Dietary strategies for prevention of CHD implicate adherence to a~     low-fat/low-saturated fat diet. Although such diets may present an effective approach, they~     are difficult to maintain on a long-term basis and efficacy diminishes over time. As such,~     new approaches towards identification of other dietary means of reducing blood cholesterol~     levels have been evaluated. These include, among others, the use of probiotics. Probiotics~     are 'live microbial feed supplements that offer a benefit to health'. They are marketed as~     health or functional foods whereby they are ingested for their purported positive advantages~     in the digestive tract and/or systemic areas like the liver, vagina or bloodstream. The main~     goal of the study is to test the efficacy of the probiotic in degrading cholesterol as well~     as produce metabolites that interfere with its synthesis in the liver in adults with high~     cholesterol (>6mmol). The effect may also be partially ascribed to an enzymatic deconjugation~     of bile acids.~   "
2043|NCT03540095|"~     Continuous paravertebral analgesia and erector spinae plane blockade (ESP) are accepted~     techniques at University of Pittsburgh Medical Center (UPMC) for the management of thoracic~     pain following surgery and trauma. Recently, an increasing number of erector spinae plane~     blocks are being performed as it has been demonstrated in our institution and via case~     reports that they provide clinical effectiveness, but may have a better side-effect profile~     than the paravertebral nerve block. However, the relative efficacy of ESP and continuous~     paravertebral analgesia for patients with rib fractures remains to be established. This study~     will include 60 consecutive patients presenting to the UPMC Presbyterian Acute Interventional~     Perioperative Pain Service suffering from unilateral rib fractures and will be randomized to~     receive either nerve blocks via continuous paravertebral infusion or via erector spinae plane~     infusion. In addition, to treat breakthrough pain, the patients in both arms will receive~     multimodal adjunctive therapy per routine. Bupivicaine and ropivicaine are FDA approved for~     use in nerve block catheters. The primary outcome will be total opioid consumption in the~     first 3 days of nerve block. Secondary outcomes include highest visual analog pain score~     (VAS) with deep breathing and at rest, adverse events, and total number of nerve blocks.~     Other data points include time to readiness for discharge, and length of hospital stay.~   "
2044|NCT03540082|"~     The purposes of this project to examine whether older adults can learn safe landing strategy~     during a fall. The research hypotheses are three-fold: 1) To determine whether older adults~     can learn a safe landing strategy to reduce impact severity of falling; 2) To examine whether~     the training effect on the right side falls can be transferred to the left side falls; and 3)~     To examine 1-week and 3-month retention effect of fall strategy training in older adults.~   "
2045|NCT03540069|"~     This research project will investigate the determinants of cervical cancer screening uptake~     and sustained utilization in this region and develop and evaluate a context-specific peer~     education behavioral intervention to improve uptake. Research supports the effectiveness of~     peer education in increasing cancer screening rates but, currently, no cervical cancer~     screening peer education program specific to rural Senegal exists. To inform the~     participatory development of this program, the investigators will assess barriers and~     facilitators of screening at multiple levels: individuals (women aged 30 to 59), households~     (family or principle social unit of at-risk women), and the community (immediate village or~     neighborhood with common amenities of at-risk women). We hypothesize that a peer education~     program that adapts to changing contexts over time and is targeted at a multi-level audience~     will result in early, widespread uptake and sustained use of the VIA cervical cancer~     screening program. Study findings will inform programmatic planning in Kedougou and the peer~     education curriculum we develop can serve as a template for maximizing early impact of new~     cervical cancer screening services implemented in other areas of rural Senegal. Our long-term~     goal is to inform national-level policy to guide the implementation of cervical cancer~     screening programs in other rural Senegal regions.~   "
2046|NCT03540056|"~     Prospective observational study.~      A varicocele is defined as a dilatation of the veins in the plexus pampiniformis in the~     testicles. Varicoceles are a diagnostic dilemma and a therapeutic challenge. Most of the boys~     with a varicocele don't show any symptoms, but approximately 15-20% experience some sort of~     infertility later during their life. There still isn't any consensus on when treating the~     patient is the right choice. Reliable scientific research about parameters able to predict~     the later stages of the boy with a varicocele is therefore needed. The purpose of this study~     is to how testicular growth could predict the outcome of boys with a varicocele.~      During this study, testicular growth in boys with and without a left-sided varicocele will be~     examined in different schools using ultrasound to measure the testicular volumes, the PRF and~     the TAI to be able to collect sufficient data with the purpose to be able to predict whether~     testicular growth is a significant predictor on the progression of a varicocele.~   "
2047|NCT03540043|"~     A Phase 2, multicenter, double-blind, placebo control study evaluating the safety and~     efficacy of Thykamine in adult patient suffering of mild-to-moderate Atopic Dermatitis~   "
2048|NCT03540030|"~     Purpose of Study:~      To identify and provide a safe, opioid-free treatment pathway for shoulder arthroplasty with~     a focus on perioperative pain control and postoperative symptoms from treatment~   "
2100|NCT03539354|"~     To compare of atrial arrhythmia incidence in patients with coronary artery disease and atrial~     fibrillation history, undergoing either coronary artery bypass grafting plus temporary spinal~     cord stimulation or coronary artery bypass grafting alone~   "
2173|NCT03538392|"~     The objective of this registry is to collect observational data under local standard of care~     and evaluate safety and performance of the Serranator® Alto in treatment of peripheral artery~     disease (PAD), or dysfunctional native or synthetic arteriovenous dialysis fistulae in a~     real-world scenario.~   "
2049|NCT03540017|"~     The majority of women diagnosed with ovarian, fallopian tube and primary peritoneal cancer~     present with advanced stage III and IV disease. Despite aggressive surgery and systemic~     chemotherapy, the majority of patients will relapse. Five year survival remains only 20-35%~     for patients diagnosed with bulky stage IIIC and IV cancers. Patients who are not candidates~     for an initial cytoreductive surgery at the time of diagnosis form a particularly poor~     prognosis group. These patients are treated with neoadjuvant chemotherapy (NACT) and will~     ultimately undergo cytoreductive surgery provided there is a response to chemotherapy. New~     therapies for this cohort of women are urgently needed.~      The investigators have designed a pilot study to evaluate the feasibility of heated~     intraoperative peritoneal chemotherapy (HIPEC) given at the time of interval cytoreductive~     surgery after 3 cycles of NACT. Patients undergoing NACT for ovarian, fallopian tube or~     primary peritoneal cancer will be evaluated after their third cycle of chemotherapy for trial~     participation. Patient meeting eligibility criteria will proceed with cytoreductive surgery.~     HIPEC will be administered in those patients in whom optimal tumor cytoreduction is achieved.~     Primary objective of this study is to evaluate the feasibility, toxicity and tolerability of~     HIPEC administered after NACT.~   "
2050|NCT03540004|"~     This is a non-randomized evaluation for which 160 adult patients will be imaged at outpatient~     wound care clinics who present with a wound of unknown infection diagnostic status and are~     receiving standard treatment. The MolecuLight i:X Imaging Device will be used as an~     adjunctive tool in the assessment of the wound and may be used to guide the targeted sampling~     of a wound (using a conventional punch biopsy method).~   "
2051|NCT03539991|"~     The goal of this research study is to develop an electronic learning (eLearning) program and~     smartphone application (app) for Spanish and Portuguese speaking cancer care providers to~     use in tobacco counseling of their patients. Researchers also want to learn if this eLearning~     program and app can provide effective tobacco counseling and treatment.~   "
2052|NCT03539978|"~     This study focuses on the delivery of discharge education by clinical nurses to improve~     parent and family self-management in the home environment. This study tests an discharge~     method (SM-THINk protocol) designed to improve the quality of care for hospitalized pediatric~     patients at the time of discharge, enhance the child's and family's experience, and decrease~     length of stay and health care utilization (ED visit or re-admission). The SM-THINk protocol~     is an enhancement to the standard clinical practice and will be implemented for all subjects~     on two Children's Hospital of Wisconsin (CHW) nursing units. This enhancement will require~     additional training of the nurses prior to implementation of the research project. This~     research determines the effectiveness of the training enhanced discharge method. The training~     is independent from the research project and will evaluate effectiveness of this training.~     For the enhanced discharge method, clinical nurses on the study units will be trained to~     deliver the Self-Management Transition to Home (SM-THINk protocol), which is based on the~     family self-management discharge preparation previously developed and tested by the study~     team.~   "
2053|NCT03539965|"~     A single-institutional cohort to determine the prevalence of new immunohistochemical panel in~     advanced triple-negative submitted to neoadjuvant chemotherapy and its association with~     response and survival.~   "
2054|NCT03539952|"~     This is a multicenter, randomized, open-label study with an active standard-of-care~     comparator (penicillamine)~   "
2055|NCT03539939|"~     Cigarette smoking is a patient-related factor that can affect healing of periodontal tissues~     and the success rate of root-coverage procedures. Neither the nature nor the mechanisms of~     action of cigarette smoking on root coverage are fully understood. Therefore, the hypothesis~     that cigarette smoking has negative impacts on the outcomes of root coverage after CAF~     surgery in systemically healthy individuals with an initial gingival thickness of at least~     0.8 mm and who practice optimal oral hygiene was tested. It was also hypothesized that~     baseline analysis of disease-related biomarkers would shed light on the underlying mechanisms~     of a possible effect.~   "
2056|NCT03539926|"~     This study evaluates the superiority of daily self-pH monitorization of Lit-control®pH meter~     compared to the monitorization of reactive strips (standard of care).~   "
2057|NCT03539913|"~     -  Primary Objective:~           o To assess the efficacy of the probiotics in reducing the duration of diarrhea in~          children suffering from acute gastroenteritis.~        -  Secondary Objectives:~             -  To assess the efficacy of the probiotics in improving the frequency and consistency~               of stools.~             -  To assess the efficacy of the probiotics in avoiding recurrence of diarrhea.~             -  To assess the efficacy of the probiotics on the disease severity.~             -  To assess the safety and tolerability of the studied probiotics.~   "
2058|NCT03539900|"~     This study will test the efficacy of naltrexone HCI and bupropion HCI (NB) versus placebo in~     patients with binge-eating disorder (BED), with or without obesity.~   "
2059|NCT03539887|"~     This project aims to evaluate the potential rapid and sustained antisuicidal and~     antidepressant effects of a single intranasal dose of ketamine in inpatients during a mood~     episode in Major Depressive Disorder (MDD) or Bipolar Disorder (BD) with or without comorbid~     recent abuse of alcohol.~   "
2060|NCT03539874|"~     Oxidative stress (OS) is characterized by an imbalance between the production of reactive~     oxygen species (ROS) and the ability of the body to eliminate them. Such an imbalance can~     lead to lipid peroxidation, DNA damage and cell apoptosis. Studies have suggested that~     infertile men are more likely to have high concentrations of ROS in their seminal plasma. We~     hypothesize that a high level of oxidative stress (OS) in patients with abnormal sperm~     parameters could influence fertilization and / or pregnancy success. Our first goal is to~     compare OS levels to semen parameters, as defined by the World Health Organization in 2010,~     as well as DNA fragmentation and chromatin decondensation in sperm. Our second objective is~     to compare OS levels in sperm to fertilization and blastulation rates at first, and then~     measure the impact of OS levels on pregnancy success, both in intrauterine insemination (IUI)~     and in vitro fertilization (IVF). Sperm samples from men in 3 groups will be analyzed: a~     group of fertile men with confirmed paternity (n = 50), a group of men in IVF (n = 100) and a~     group of men in their first three cycles of IUI (n = 100). The static oxidation reduction~     index (sORP) will be measured by the MiOXSYS © system, a rapid sperm analysis system using~     electrochemical technology. A small portion of the fresh sperm sample will be deposited on a~     MiOXSYS sensor and the ORP will be measured. Sperm ROS will also be measured using the~     CellROX Deep Red probe. The sperm parameters will be measured by the techniques used~     routinely in the Fertilys Reproductive Health Center andrology lab. Regarding couples in IVF,~     fertilization and blastulation rates, embryo quality and pregnancy success will be noted.~     Pregnancy success will be noted for IUI couples. If the usefulness of sORP levels in~     predicting pregnancy and its outcome is demonstrated, it could be a new marker in the~     diagnosis of male infertility and act as a guide for clinicians to apply appropriate~     treatment.~   "
6459|NCT03482284|"~     The aim of the present study is to determine the effect of monosaccharides on intestinal~     barrier function in healthy subjects.~   "
2061|NCT03539861|"~     Hemodialysis is a therapy that filters waste, removes extra fluid and balances electrolytes.~     In hemodialysis, blood is removed from the body and filtered through a man-made membrane~     called a dialyzer, and then the filtered blood is returned to the body. Hemodialysis is~     associated with injury to the heart muscle called myocardial stunning. This may occur for~     many reasons, including removal of fluid during dialysis or low blood pressure. Initial~     ischemia and subsequent white blood cell infiltration into the injured myocardium play a~     critical role in the degree of myocardial ischemia reperfusion injury.~      In this study an additional man made membrane (selective cytopheretic device) and tubing will~     be added to the dialysis circuit. The device shifts the circulating white blood cells pool to~     a less inflammatory phenotype. Researchers believe the selective cytopheretic device will~     alter the phenotype of circulating white blood cells which play a role in myocardial~     stunning.~      The purpose of this study is to evaluate whether the selective cytopheretic device will~     reduce myocardial stunning events in hemodialysis patients. It will also report the rate of~     adverse events.~   "
2062|NCT03539848|"~     The purpose of this research study is to test whether a portable goggle system (I-PAS) is~     good at diagnosing mild traumatic brain injury (mTBI) in a community setting. The goal is to~     determine whether the IPAS goggle system can be used reliably in an urgent care or emergency~     department setting.~   "
2063|NCT03539835|"~     This study will begin to fill a knowledge gap by determine whether changes in kynurenine~     metabolism occur following Resistance Training (RT) and relate to reductions in inflammation~     and improved behavioral and physical function as this may identify potential targets for~     interventions to promote cancer recovery.~   "
2064|NCT03539822|"~     The investigators propose to evaluate cabozantinib in combination with durvalumab in~     previously treated patients with advanced gastroesophageal cancer and other gastrointestinal~     (GI) malignancies. Finding effective novel therapies after failing the current standard of~     care chemotherapy options for patients with advanced gastric cancer and other GI malignancies~     is an area or great unmet need. The investigators believe that modulating the tumor~     microenvironment with biologic agents like cabozantinib will have synergistic effect when~     combined with checkpoint-based immunotherapeutics like durvalumab in this patient population.~     This is a phase 1b, open label, single arm trial looking at safety, tolerability and~     preliminary efficacy endpoints.~   "
2065|NCT03539809|"~     This study will evaluate the branched-chain amino acids (BCAA) ratio in the medical foods~     formulated for Methylmalonic and Propionic Acidemias (MMA/PROP) patients. We will recruit 6~     healthy children between 6-10y (3 boys and 3 girls). They will be given amino acid-based~     shakes and protein free cookies. Using a minimally invasive stable isotope based technique,~     we will be able to determine the optimal ratio of BCAA to be added in the medical foods for~     the MMA/PROP subjects.~   "
2066|NCT03539796|"~     The main objective of this study will be to determine if the dural puncture epidural (DPE)~     provides superior analgesia and better patient satisfaction when compared to traditional~     epidurals for cesarean sections, and to also determine if patient satisfaction in the DPE~     group is comparable to that of the CSE technique.~   "
2067|NCT03539783|"~     Pediatric acute respiratory distress syndrome (PARDS) is a severe and diffuse lung injury~     that is a common cause of admission and mortality in the pediatric intensive care unit~     (PICU). PARDS can be secondary to many different causes, and there are few therapies that~     have been shown beneficial in PARDS. This study seeks to identify important PARDS subtypes~     using gene expression profiling of nasal and bronchial epithelial cells from endotracheally~     intubated control and PARDS subjects.~   "
2068|NCT03539770|"~     Adolescent Idiopathic Scoliosis (AIS) is a curvature of the spine that occurs in 1-2% of~     otherwise healthy children, and requires corrective surgery, posterior spinal fusion (PSF) in~     ~10% of cases. Some studies suggest that pulmonary function is reduced in AIS and that PSF~     improves pulmonary function. The lung is composed of a large number of branching airways that~     terminate in gas exchanging units called alveoli, and the number and structure of these~     alveoli are partially dependent upon lung volume and the forces to which they are~     exposed--two factors predicted to be altered in AIS. This study uses MRI imaging of inhaled~     helium to quantify alveolar structure in children with and without AIS before and one-year~     after PSF. The goals of the study are to determine if alveolar architecture or number are~     altered in AIS and whether PSF impacts these same measures.~   "
2069|NCT03539757|"~     In this research study, the investigators will conduct a prospective cross-sectional study of~     pediatric and adult Fontan patients that will correlate a variety of quantitative MRI~     biomarkers with histopathologic data.~   "
2070|NCT03539744|"~     A study designed to evaluate the safety and efficacy of venetoclax plus dexamethasone~     (VenDex) compared with pomalidomide plus dexamethasone (PomDex) in participants with~     t(11;14)-positive Relapsed or Refractory Multiple Myeloma.~      Subjects randomized to Arm 2 (PomDex) may elect, if eligible, to receive VenDex therapy after~     documented disease progression per International Myeloma Working Group (IMWG) criteria.~   "
2071|NCT03539731|"~     This phase I trial studies how well [18F]DASA-23 and positron emission tomography (PET) scan~     work in evaluating pyruvate kinase M2 (PKM2) expression in patients with intracranial tumors~     or recurrent glioblastoma and healthy volunteers. PKM2 regulates brain tumor metabolism, a~     key factor in glioblastoma growth. [18F]DASA-23 is a radioactive substance with the ability~     to monitor PKM2 activity. A PET scan is a procedure in which a small amount of a radioactive~     substance, such as [18F]DASA-23, is injected into a vein, and a scanner is used to make~     detailed, computerized pictures of areas inside the body where the substance is used. Tumor~     cells usually pick up more of these radioactive substances, allowing them to be found. Giving~     [18F]DASA-23 with a PET scan may help doctors evaluate PKM2 expression in healthy volunteers~     and in participants with intracranial tumors or recurrent glioblastoma.~   "
2072|NCT03539718|"~     To assess the efficacy of Taurolock-hep500™ as anticoagulant and antimicrobial catheter lock~     solution in comparison to unfractionated heparin as alock solution to improve performance of~     hemodialysis catheters and quality of hemodialysis .~   "
2073|NCT03539705|"~     This is a registry of participants who are interested in being screened for clinical trials~     at a single site.~   "
2074|NCT03539692|"~     This is a protocol for prescreening of participants who would like to be in clinical studies~     in our Center at Stanford.~   "
43034|NCT03003481|"~     Collect patient data and to monitor the clinical use (safety and efficacy) of the device~   "
2075|NCT03539679|"~     The most important goal is to create a cost-effective, stimulating model for improving the~     employee's quality of life, work ability, and job satisfaction in the military operating~     environment. This is achieved by finding out how to activate an individual with the~     phone-based gaming and web-based feedback system to improve his physical condition. This~     study also tries to find out the adequate amount of physical activity to maintain the~     physical health of workers.~      Personnel work ability, to work safe in service and effective operation capability of~     emergency forces require a worker's state of total well-being, in which the health and the~     physical condition are important parts. The changes in these affects the individual's fitness~     to military. This study develops a model to encourage an individual to carry out physical~     activity by himself. This will lead to reduce the sick leaves and improve the health and~     fitness.~      Physical activity reduces morbidity. Professional soldiers must maintain their physical~     condition and skills. The study explores the optimum amount of working-age physical activity.~     It helps to maintain the working ability and one's fitness to field operations. With the help~     of the developed model it is possible cost-effectively activate a large number of employees~     to move more and to live more healthily.~   "
2076|NCT03539666|"~     The project will characterize human gut microbiome response to two different diets and the~     possible physiological and biochemical implications of such response on cardiometabolic risk~     factors. The study will use controlled-feeding, systems-biology, metagenomic, and metabolomic~     approaches to examine American dietary patterns.~   "
2077|NCT03539653|"~     The purpose of this study is to investigate the effect of Gastric Antrum Ultrasonography on~     Early Stage of Enteral Nutrition in Critically Ill Patients.~   "
2078|NCT03539640|"~     This study evaluates the effect of positive end-expiratory pressure on the position, length~     and function of the diaphragm. During the first part of the study, physiological measurements~     of the diaphragm will be performed while participants receive non-invasive ventilation at~     different PEEP levels. During the second part of the study, MRI measurements of the diaphragm~     will be performed during a change in PEEP level.~   "
2079|NCT03539627|"~     One-center, observational, non-interventional, prospective study of the efficacy of~     azilsartan medoxomil in patients with arterial hypertension associated with stable ischemic~     heart disease and type 2 diabetes mellitus.~   "
2080|NCT03539614|"~     Posttraumatic stress disorder (PTSD) affects many individuals who experience a traumatic~     event. There are a variety of treatment options for PTSD, including psychotherapy (talk~     therapy) options, as well as medications, such as the drug prazosin. Each of the treatment~     options available is effective at significantly reducing the symptoms of PTSD in some, but~     not all, individuals with PTSD. However, investigators are not yet able to predict in advance~     who is likely to respond to which of the available treatments. Neither are the investigators~     able to explain what changes in the brain after exposure to a traumatic stressors, and why it~     results in persistent symptoms of PTSD for some people, but not for others.~      In this study, the investigators are testing two things: First, is testing whether two~     simple, easy tests of how an individual's blood pressure changes with standing and how an~     individual's eye reacts to a pulse of light may be able to predict whether that person is~     likely respond to the medication prazosin for PTSD. Second, is testing whether those who have~     been exposed to a traumatic stress show differences in how their body regulates the response~     to the stress-signal noradrenaline.~   "
2081|NCT03539601|"~     This 4-week study will evaluate the safety and efficacy of crisaborole ointment 2%;~     crisaborole vehicle; topical corticosteroid and topical calcineurin inhibitor, applied twice~     daily (BID) in subjects who are at least 2 years of age with mild-moderate AD.~   "
2082|NCT03539588|"~     trigger point dry needling with intramuscular electrical stimulation vs trigger point dry~     needling~   "
2083|NCT03539575|"~     The purpose of this research study is to determine whether the CB1R availability is lower in~     synthetic psychoactive cannabinoid subjects using the most widely available synthetic~     psychoactive cannabinoids at the time the study is initiated.~   "
2084|NCT03539562|"~     This will be a prospective study on obstetric and neonatal outcomes in women who accept and~     women who decline morphine as a form of pain management in labor. The study will also~     investigate patient satisfaction and cost effectiveness in these two groups of patients. Half~     of the participants will be those who accept morphine and the other half will be those who~     decline morphine for pain control.~   "
2085|NCT03539549|"~     The objective of this study is to evaluate abicipar for safety and treatment effect in~     patients with neovascular Age-related Macular Degeneration (AMD).~   "
2086|NCT03539536|"~     This study is designed to identify the target Non-Small Cell Lung Cancer (NSCLC)~     population(s) that over express c-Met (c-Met+) best suited for telisotuzumab vedotin therapy~     in the second line or third line setting (Stage 1) and then to expand the group(s) to further~     evaluate efficacy in the selected population(s) (Stage 2).~   "
2087|NCT03539523|"~     The aim of the study was to investigation of the validity and reliability of the L test in~     children with cerebral palsy. Eighty children with CP with mean age of 11.60±3.85 (56 boys,~     24 girls) were included in the study. ICC ((Intraclass Correlation Coefficient) was used to~     assess interclass, intraclass and test- retest validity of the L test. Two independent~     examiners made L test, for the inter-rater reliability, twice within 1 day for the~     test-retest reliability. The minimal clinical important difference at 95% confidence interval~     intra-class correlation coefficient and standard error of measurements were calculated. The~     correlations of L test with Timed up and Go Test (TUG) and Timed up and Down Stairs Test~     (TUDS) were assessed for concurrent validity.~   "
2088|NCT03539510|"~     This study evaluates the effectiveness of an interactive website on advance care planning for~     patients living with heart failure (HF-ACP website). The investigators will randomize~     patients to either the HF-ACP website or usual care to determine if the participants who use~     the HF-ACP website have higher advance care planning completion rates than participants~     assigned to usual care.~   "
2133|NCT03538925|"~     The focus of this investigation is to compare the effectiveness of the AAC Generative~     Language Intervention approach to an AAC Standard of Care condition on preschool sentence~     productions. All children will use existing AAC iPad applications.~   "
3348|NCT03523039|"~     This prospective single-centre randomized control trial aims at evaluating the safety and~     efficacy of hemoadsorption with CytoSorb® in 40 patients with Post-Cardiac Arrest Syndrome~     admitted to the ICU.~   "
2090|NCT03539484|"~     This study will determine the maximum-tolerated dose (MTD) and/or the optimal biological dose~     (OBD) as well as the optimal schedule for intravenous (IV) and subcutaneous (SC)~     administrations of RO7172508 as monotherapy in participants with locally advanced and/or~     metastatic carcinoembryonic antigen (CEA)-positive solid tumors who have progressed on~     standard of care (SOC) treatment, are intolerant to SOC, and/or are non-amenable to SOC. This~     study will be conducted in two parts. Part I of the study will consist of an IV single~     participant cohort/multiple-ascending dose-escalation to evaluate the safety of RO7172508.~     Part II is a multiple participant cohort/multiple-ascending dose-escalation to define the MTD~     and/or OBD of RO7172508 administered as single agent, IV and/or SC, in participants with~     tumors that are expressing high as well as moderate/low-CEA. The study will switch from Part~     I to Part II when the maximum planned dose for Part I is reached or the occurrence of a~     RO7172508-related Grade >= 2 adverse event (AE) or dose-limiting toxicity (DLT) is observed,~     whichever comes first. The Sponsor may decide to switch from Part I to Part II in the absence~     of an observed RO7172508-related Grade >= 2 toxicity or prior to maximum planned dose for~     Part I.~   "
2091|NCT03539471|"~     Agitation, paranoia, and suicide risk of the psychiatric patients made them difficult to be~     managed when they visited medical emergency services. The prolonged waiting time at medical~     emergency services and the stigmatization of psychiatric medicine also made the psychiatric~     emergency services full of challenges. However, in recent years, the random killings,~     celebrity suicide and other major social events attracted much attention to the emergency~     psychiatry.~      Following the establishment of the National Health Insurance, the law of mandatory admission,~     and the prevalence change of all psychiatric diseases, we are now dealing with totally~     different types of emergent psychiatric conditions, i.e., depression and suicide. However,~     the real epidemiological data need to be updated. Psychiatric emergency is one of the~     entrances of the psychiatric network. A comprehensive review of the psychiatric emergency~     would be needed for the base of further research.~      This study is aimed to investigate the prevalence of psychiatric diagnosis of patients who~     came to Emergency Department of National Taiwan University Hospital and needed a psychiatric~     consultation. The epidemiological data will be compared to those collected 30 years ago in~     the same hospital to examine the 30-year trend. On the other hand, the visiting time and the~     staying time will be analyzed. The stress of on-duty and the contributing factors will be~     assessed by a 2-hour in-depth interview with psychiatric residents.~   "
2092|NCT03539458|"~     This study is a prospective, single-arm, multi-center feasibility clinical study of the~     Tendyne Mitral Valve System for the treatment of subjects with symptomatic, severe mitral~     regurgitation and severe mitral annular calcification. Subjects satisfying the study criteria~     will undergo a procedure to implant the Tendyne mitral valve replacement device.~   "
2093|NCT03539445|"~     Butylphthalide, as a well-known neuroprotective medication, is a family of compounds~     initially isolated from the seeds of Apium graveolens Linn, of which active ingredient is~     dl-3-N-butylphthalide (dl-NBP). With the significant effects of reducing the cerebral~     ischemic damage and eventually improving patients' clinical outcomes, by the potential~     mechanisms of promoting microcirculation, as well as releasing oxidative stress,~     mitochondrial dysfunction and poststroke inflammation, dl-NBP has been widely applied in~     acute ischemic stroke as an anti-ischemic drug in China since 2002. While with the evolution~     of using iv. recombinant tissue plasminogen activator（rtPA ）and mechanical thrombectomy in~     acute ischemic stroke（AIS）patients, it is still undefined whether combination therapy with~     dl-NBP could enhance the curative effect. The primary purpose of this trial is to evaluate~     the recovery of neurological deficits in AIS patients who receive iv-rtPA and/or mechanical~     thrombectomy with the a 3-month regimen of Butylphthalide and Sodium Chloride Injection 100ml~     twice/day in the initial 14 days and Butylphthalide Soft Capsules 0.2g triple/day for the~     rest 15th to 90th day therapy versus a 3-month regimen of Butylphthalide Placebo Injection~     100ml twice/day in the initial 14 days and followed by Butylphthalide Placebo Soft Capsules~     0.2g triple/day for the rest 15th to 90th day therapy.~   "
2094|NCT03539432|"~     This study will examine the efficacy of the medication gemfibrozil in reducing alcohol~     consumption in individuals with an alcohol use disorder who are seeking treatment for~     alcohol-related problems. Twenty individuals will be randomized to receive four weeks of~     either gemfibrozil or placebo and retrospective reports of alcohol use will be collected~     throughout the trial. In addition, brain imaging measures will be collected at baseline and~     after two weeks of treatment to determine the effects of gemfibrozil on brain functioning.~   "
2095|NCT03539419|"~     Observational, prospective and multicenter study in approximately 30 sites nationwide. The~     investigators participating in this study will be dermatologists specializing in this~     pathology.~      The present study will include adult patients with moderate to severe plaque who have started~     apremilast treatment for first time 3 months (+/- 4 weeks) before their inclusion in the~     study, according to the specifications of the drug's prescribing information and under usual~     clinical practice. Recruitment will be consecutive and the reason for not including a~     potential candidate patient will be registered. The decision to prescribe apremilast~     treatment should be clearly dissociated from the inclusion of the patient in the study.~     Therefore, the choice of the therapeutic strategy will be made independently by the~     physician.~   "
2096|NCT03539406|"~     This study investigates an innovative treatment for recurrent ovarian cancer exploiting ex~     vivo-generated allogeneic natural killer (NK) cells with or without preceding~     non-myeloablative conditioning chemotherapy.~   "
2097|NCT03539393|"~     This expanded access program is designed to make fremanezumab available to patients with EM~     or CM who have successfully completed (per protocol) Teva-sponsored Study TV48125-CNS-30051~     or TV48125-CNS-30068 (prior studies) until fremanezumab becomes commercially available in~     their country.~   "
2098|NCT03539380|"~     This is an expanded access program (EAP) for eligible participants. This program is designed~     to provide continued access to TRx0237 to individual patients with mild-moderate Alzheimer's~     disease who do not qualify for participation in an ongoing clinical trial. Eligible~     participants must have previously completed participation in a clinical trial of TRx0237~     conducted by TauRx, among other criteria.~   "
2099|NCT03539367|"~     Randomized, placebo controlled trial evaluating the effect of acetazolamide on lung water~     content by ultrasound in lowlanders older than 40 years travelling from 760 m to 3'100 m.~   "
43675|NCT02995122|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
2101|NCT03539341|"~     Pilot design:~      The feasibility pilot of PLH for Young Children in Thailand has a single-site, pre-post~     design with no control group, with the aims of assessing programme implementation, cultural~     and contextual relevance, and study feasibility. Although there is no comparison group and it~     is not designed to test effects, the pilot also has a provisional goal of reductions in child~     physical and emotional abuse at one-month post-intervention.~      RCT design:~      The RCT of PLH for Young Children Thailand is a randomized, controlled, observer-blinded,~     single-site trial with two parallel groups and a primary endpoint goal of reductions in child~     physical and emotional abuse at one month and three-months post-intervention. Randomisation~     will be performed at the individual level with a 1:1 allocation ratio.~      Allocation: Using a 1:1 allocation ratio, the 120 participants will be randomly assigned to~     either the intervention or control group using the concealed computerized programme Sealed~     Envelope. An external researcher based at the Department of Social Policy and Intervention at~     the University of Oxford, and who is not directly involved in the study, will generate the~     random sequence. The Project Coordinator and Co-Investigator McCoy will notify participants~     of their allocation status via telephone following the collection of baseline data, in order~     to ensure that participants remain blind to their status during the initial assessment.~      Blinding: Due to the involvement of facilitators and coaches in the delivery of the~     programme, blinding will not be possible for deliverers; moreover, participants cannot be~     blinded to their allocation status following the initial assessment. However, the allocation~     status of other participants will be kept concealed from participants in order to reduce the~     risk of contamination. Data collectors gathering outcome and process evaluation data, as well~     as statisticians providing support in data analysis, will be blinded to participant~     allocation status for the purposes of minimizing assessment bias. Cases of compromised~     blinding will be immediately reported to the Research Manager, who will consult with the~     research team on an appropriate course of action. Un-blinding of participants will only be~     permitted if any instances of significant harm due to participation in the study are reported~     by a participant or any member of the project team at any stage of the study.~   "
2102|NCT03539328|"~     The study is designed to assess the therapeutic efficacy and toxicity of the combination~     chemotherapy with pembrolizumab in recurrent, platinum resistant OC patients. The main~     objective is to test whether the therapeutic intervention benefits the patients evaluating~     the increase in overall survival with respect to chemotherapy alone.~   "
2103|NCT03539315|"~     The primary purpose of this research is to conduct a brief project to adapt and evaluate an~     evidence-based intervention model to address reproductive coercion and unintended pregnancy~     (ARCHES - Addressing Reproductive Coercion within Healthcare Settings) to the Bangladesh~     cultural context and for use with abortion clients (i.e., develop ARCHES Bangladesh) so as to~     provide initial assessment of acceptability, feasibility and effectiveness in this high-need~     LMIC context. Globally, addressing violence and coercion from male partners is considered key~     to reducing unintended pregnancy among adult and adolescent women. This has led to multiple~     efforts to integrate IPV screening and counseling in health settings, particularly in the~     context of family planning, across a range of middle and low-income countries. However, to~     date, no existing model addressing reproductive coercion has demonstrated reduction in risk~     for unintended pregnancy, either for Bangladesh or any other country.~   "
2104|NCT03539302|"~     The study consists of 2 parts (Part A and Part B). Part A has an open-label, randomized,~     multi center design to evaluate the feasibility of administration of inhaled flecainide in~     two dosing regimens. Part B has a randomized, double-blind, parallel group,~     placebo-controlled, multi center design to evaluate the safety (including tolerability) and~     efficacy of inhaled flecainide compared to matched placebo in two dosing regimens.~   "
2105|NCT03539289|"~     The primary objective is to compare the incidence of gastrointestinal AEs in patients treated~     with IPF, initiating pirfenidone for the first time, according to the type of diet (MUFA vs~     SFA). Gastrointestinal AEs rates between study groups will be evaluated during the first 16~     weeks of pirfenidone treatment.~   "
2106|NCT03539276|"~     An education intervention to promote medication reviews and interdisciplinary discussions~     within long-term care facilities with the aim of improving medication regimen among residents~     with severe dementia~   "
2107|NCT03539263|"~     Recent demonstration that probiotics administration has positive effects on depressive~     feelings in healthy populations suggests its possible role as an adjuvant therapy for~     depression in clinical populations and as a non-invasive strategy to prevent depressive~     feelings in healthy individuals. The present study extends current knowledge on the~     beneficial effects of probiotics on psychological well-being, as measured by changes in mood~     (e.g., depression, anxiety, cognitive reactivity to sad mood), personality dimensions, and~     quality of sleep, which have been considered as related to mood. For this double-blind,~     placebo-controlled study healthy volunteers pseudo-randomly assigned to an experimental or~     control group assumed a daily dose of probiotic or placebo, respectively, for 6 weeks. Mood,~     personality dimensions, and sleep quality were assessed four times (before the beginning of~     the study, at 3 and 6 weeks, and at 3 weeks of washout).~   "
2108|NCT03539250|"~     Radiation-induced temporal lobe injury (TLI) is usually devastating to patients; however,~     there is a poor understanding of TLI in nasopharyngeal carcinoma (NPC) patients treated with~     IMRT. Knowledge of the dose tolerance of the TL is essential, in order to predict the safety~     of intensity-modulated radiotherapy (IMRT) treatment plans. In our previous studies, D1cc~     (the dose to 1ml of the TL volume) and Dmax (the maximum point dose) were the significant~     predictors of TLI development. The purpose of this study is to evaluate the feasibility of~     dose constraints based on D1cc and Dmax for the temporal lobes following IMRT for NPC.~   "
2109|NCT03539237|"~     This study examines the effect of a video-based intensity level demonstration on~     self-reported physical activity in individuals aged between 40 and 75 years. Aim of the video~     demonstration is to achieve a better concordance of physical activity reports with~     accelerometer-based measurements.~   "
2110|NCT03539224|"~     Phase IIa, open clinical trial, pilot, single arm and proof of concept.~   "
2111|NCT03539211|"~     This study evaluates the effect of a rotation based exercise program on core muscle~     thickness. Additionally, a second aim is to demonstrate the ability of a clinical assessment~     tool to identify muscle thickness changes. Half of participants receive the rotation based~     exercises, while the other half perform a traditional core exercise program. It was~     hypothesized that the rotation based exercises would result in greater changes in muscle~     thickness.~   "
2112|NCT03539198|"~     This study observes the clinical efficacy of combining proton SBRT with PD-1 blockade~     immunotherapy in both the locoregionally recurrent and metastatic settings.~   "
2144|NCT03538782|"~     Percutaneous transhepatic biliary drainage (PTBD) procedures are associated with an elevated~     radiation exposure for the patient. In the recently published guideline of the Federal Ofﬁce~     for Radiation Protection in Germany diagnostic reference levels (DRLs) for dose area products~     (DAP) are not defined for PTBD procedures due to insufficient data. The aim of this~     retrospective study is to give a nation-wide survey on patients radiation exposure in~     different PTBD procedures considering factors that may have an impact on increased radiation~     exposure like fluoroscopic-guided versus ultrasound-guided bile duct puncture.~   "
2113|NCT03539185|"~     The airway management is a vital act in anesthesia, but it's not always easy. The gold~     standard technique for planned very difficult intubation is nasotracheal fiberoptic~     intubation. The success rate with this procedure is 98.8%. However, learning this technique~     is difficult and it is considered uncomfortable by patients and practitioners.~      The Airtraq® videolaryngoscope is commonly used for difficult orotracheal intubation. Cases~     of awake intubation by Airtraq® have been described.~      Furthermore, the French Society of Anesthesia-Resuscitation, in its last formalized expert~     recommendations of 2017 on difficult intubation proposes the use of video laryngoscopes as an~     alternative to the fiberoptic broncoscope.~      We propose a non-inferiority study evaluating the use of Airtraq® for the realization of a~     awake intubation compared to the reference technique (fiberoptic broncoscope). This~     prospective and randomized study should include 78 patients in two groups. The purpose of~     this study is to improve the comfort of patient and practitioner during an awake tracheal~     intubation, to facilitate the learning of the technique.~   "
2114|NCT03539172|"~     This is a non-randomized, phase II, open label study of radiotherapy concurrent with Apatinib~     Mesylate after surgery in patients with advanced head and neck soft tissue and bone sarcomas.~     The primary purpose of this study is to evaluate the efficacy and safety of Apatinib Mesylate~     in patients with head and neck soft tissue and bone sarcomas.~   "
2115|NCT03539159|"~     Rationale: Serum eye drops (SEDs) are used to treat patients with severe signs and symptoms~     of dry eyes and other corneal defects. Serum is used in severe ophthalmic cases where~     conventional treatment and/or eye drops (artificial tears) have insufficient effect. The use~     of SEDs in dry eye patients usually has a rapid effect. Most patients claim the effect to be~     instantaneous, and most symptoms improve within 48-72 hours.~      There is evidence suggesting that substances in serum may help in the healing of epithelial~     defects, such as epidermal growth factor, fibroblast growth factor, fibronectin, and/or~     vitamin A. However, the precise serum factor responsible for alleviating the patient's~     complaints is currently not known.~      SEDs are considered as a blood product under EU blood legislation (Directive 2002/98/EC), as~     well as in New Zealand and Australia. Commonly, autologous SEDs are used, but they are~     replaced more and more by allogeneic SEDs prepared from donor serum. Allogeneic SEDs are~     derived from healthy voluntary, non-remunerated male donors with blood group AB, and have the~     benefit of blood bank controlled quality. They can be delivered from stock and are therefore~     quickly available for each patient.~      For application of eye drops, generally administration systems with a drop size of 40 to 50~     µl are used, further on referred to as conventional sized eye drops. From previous studies~     done with medicinal eye drops, it has been shown that smaller eye drops, so called micro~     drops, can be just as effective and sometimes even superior to conventional drops for~     treatment of eye disease. If micro drops are just as effective or maybe even superior to~     conventional sized eye drops is currently unknown for the use of SEDs. This study will~     compare the feasibility and effectiveness of allogeneic serum micro eye drops using the~     mu-Drop applicator to the conventional sized allogeneic eye drops using the Meise applicator.~     Both systems have a closed manufacturing system.~      Objective: The main objective is to determine whether the administration of allogeneic serum~     micro eye drops is non-inferior in terms of effectiveness and safety as compared to the~     conventional sized drops.~      Main study parameters/endpoints: The primary endpoint is the improvement in OSDI score by~     using SEDs (OSDI score after treatment minus OSDI score before treatment), independent of the~     drop size, showing non-inferiority for the use of micro drops as compared to conventional~     sized drops.~   "
2116|NCT03539146|"~     Coffee processing byproducts, such as coffee cascara (outer skin and pulp of the coffee~     berry), have potential health promoting properties due to the presence of bioactive~     compounds. Its use as a novel food ingredient is a means of valorizing this fractioin in the~     elaboration of functional yogurts. The addition of cascara extract in yogurt affects its~     texture quality. The addition of dietary fiber can help regain the structure of the yogurt's~     gel. However, secondary gastrointestinal effects associated with acute fiber ingestion must~     be considered.The aim of this clinical trial is to study the gastrointestinal tolerance,~     satiation and sensory acceptance of yogurts containing both coffee cascara extract and~     different doses of commercial soluble dietary fiber.~   "
2117|NCT03539133|"~     Despite progress in pre-hospital care, ambulance logistics, pharmacotherapy and PPCI~     techniques, ST-segment elevation myocardial infarction (STEMI) continues to confer a~     substantial burden of morbidity and mortality.~      Within the STEMI population, there is a spectrum of higher and lower risk patients. The aim~     of this registry is to collect prospectively and systematically clinical research data from~     STEMI patients. This registry is an open-end observational study to identify master switches~     in myocardial ischemia.~   "
2118|NCT03539120|"~     This is a retrospective data analysis of patients who underwent lower limb amputation and~     rehabilitation and follow up.~      Investigators analysed their survival outcomes in relation to various comorbidities i. e~     ischaemic heart disease, renal impairment, vascular interventions.~   "
2119|NCT03539107|"~     This study will compare voiding assessment based on a minimum spontaneous voided volume of~     150 cc with the standard retrograde fill approach in women after pelvic floor procedures.~   "
2120|NCT03539094|"~     This is a randomized controlled trial that will test the effects of intermittent fasting (IF)~     in subjects with relapsing-remitting MS (RRMS). The goal of this clinical trial is to acquire~     objective evidence regarding whether an IF diet has beneficial effects in MS patients.Two~     dietary regimens, IF and western diet, will be compared in a randomized, controlled,~     single-blinded 12 week trial in RRMS patients. This is a single-center study.~   "
2121|NCT03539081|"~     The overall goal of this proposed study is to evaluate the underlying mechanisms of neural~     control of blood flow in the lower extremities in humans with restless leg syndrome (RLS). At~     least 15% of the general public suffers from RLS and many more may go undiagnosed. This~     unfortunate disorder leads primarily to a disturbing sensation within the patient's lower~     extremities that requires movement for relief (1, 2). The central hypothesis of our study is~     that physiological changes in lower limb blood flow as a result of thoracolumbar epidural~     Spinal Cord Stimulation (SCS) lead to the relief of RLS.~   "
2134|NCT03538912|"~     Empirical antifungal therapy (EAT) is frequently prescribed to septic critically ill patients~     with risk factors for invasive Candida infections (ICI). However, among patients without~     subsequent proven ICI, antifungal discontinuation is rarely performed, resulting in~     unnecessary antifungal overuse.~      The investigators postulate that the use of fungal biomarkers could increase the percentage~     of early discontinuation of EAT among critically ill patients suspected of ICI, as compared~     with a standard strategy, without negative impact on day 28-mortality.~      To test this hypothesis, the investigators designed a randomized controlled open-label~     parallel-group study.~   "
2169|NCT03538444|"~     This double-blind, randomized, controlled trials will investigate the effect of accelerated,~     repeated transcranial magnetic stimulation on opiate craving and perceived pain .~   "
2433|NCT03534986|"~     The impact of high-frequency chest wall oscillation therapy on spirometry values (Forced~     Expiratory Volume, Forced Vital Capacity, Peak Expiratory Flow, Forced Expiratory Flow and~     Tidal Volume is investigated during use of several products and comparing to baseline values.~   "
2122|NCT03539068|"~     OEF/OIF/OND war Veterans have unique post-deployment care needs that the VA is striving to~     understand and address. Unfortunately, there is a significant disparity in utilization of~     mental health (MH) care and VA access as most war Veterans don't seek needed care. New~     interventions are urgently needed to address disparities in post-deployment MH treatment~     engagement for war Veterans and to support VA's efforts to provide them with optimal access~     and care. Online health interventions have been shown to be preferred by OEF/OIF combat~     Veterans and have the potential to promote access to VA MH care. The investigators' research~     team has developed a web-based interface (WEB-ED) evolved by feedback from Veterans that~     screens for common post-deployment MH and readjustment concerns, provides tailored education~     about positive screens, and facilitates linkage to VA resources. Data from the investigators'~     prior studies demonstrate WEB-ED can be successfully implemented within VA and activate~     Veterans to seek needed care. Furthermore, emerging evidence indicates that when patients are~     educated about their health conditions and treatment alternatives using shared~     decision-making (SDM), increased treatment participation and adherence, and better health~     outcomes result. Next steps include: linking Veteran WEB-ED screening results to a VA secure~     network so that a provider can access the results; and integrating a SDM interface to promote~     Veteran-Provider partnerships in patient-centered care. This study will improve the~     investigators' understanding of the most effective methods to reduce barriers to enrollment~     in VA/MHV and transferring important medical information using My HealtheVet (MHV).~     Furthermore, it will provide important information regarding how WEB-ED results can enhance~     the capability of VA providers and transition patient advocates to use Veterans' screening~     results to triage and engage Veterans in patient-centered MH care and promote VA provider~     adoption of WEB-ED+ to facilitate patient engagement. Online screening, tailored education,~     and links to geographically accessible VA resources has been shown to be preferred by~     Veterans, providing recognition of treatable post-deployment MH concerns, and education that~     reduces stigma. This study builds upon and augments this prior work with research to~     understand and evaluate the processes needed to integrate WEB-ED+ into current VHA systems to~     support efficient care delivery, facilitate patient-centered care, and address unmet need for~     MH care while also resolving disparities in VA and VA MH care access and engagement for war~     Veterans. WEB-ED+'s use of shared decision making is a key component for promoting these~     benefits. WEB-ED+ represents a readily implementable and cost-effective intervention that,~     with partner collaboration, can be integrated into VA systems through MHV. Findings have~     important policy implications for several operational partners heavily invested in the~     improved access and delivery of evidence-based mental health care for war Veterans.~   "
2123|NCT03539055|"~     Single arm, prospective unblinded study on post Watchman LAA closure device implant~     anti-coagulation management at a primary center (Vanderbilt Medical Center) and up to 5~     additional high volume LAA implant centers. This trial will be designed to evaluate the use~     of dabigatran for 90 days post implantation of an LAA closure device (Watchman LAA Closure~     Device, Boston Scientific Inc.) to prevent device related thrombus.~   "
2124|NCT03539042|"~     This study seeks to examine genome-wide DNA methylation patterns associated with physical~     activity and exercise capacity from peripheral blood collected from participants with chronic~     obstructive pulmonary disease (COPD) before and after participation in a structured 9-week~     outpatient pulmonary rehabilitation program.~   "
2125|NCT03539029|"~     The decision whether to operate an ankle fracture or not is often highly dependent on the~     surgeon's individual judgment. There is consensus that non-displaced Weber A-type fractures~     rarely require operative treatment, and that Weber C-type or grossly displaced fractures are~     unstable and therefore require surgery. The decision for appropriate treatment is less clear~     for minimally displaced Weber B-type ankle fractures, and especially Weber B1 fractures are~     treated either surgically or conservatively at our clinic.~      Conservative management of ankle fractures generally comprises immobilisation in a below-knee~     VacoPed or cast for six weeks to stabilise the fracture and allow osseous and soft tissue~     healing. Surgical treatment involves the reduction (if displaced) of the fractured fragments~     and fixation using various devices such as metal plates, screws, or intramedullary rods.~     While patients show changes in plantar pressure distribution during gait 18 months after~     surgical treatment of ankle fractures, to date the functional outcome regarding ankle joint~     mechanics during daily activities are unknown. Understanding gait function is important~     because compromised function may not only limit a persons daily activities but also may lead~     to secondary conditions such as osteoarthritis at the ankle or at adjacent joints.~      The primary objective is:~      • To compare differences in hindfoot and forefoot kinematics between level and uphill~     treadmill walking in relation to passive range of motion~      The secondary objectives are:~        -  To compare ankle biomechanics during overground walking and level and uphill treadmill~          walking between patients with Weber B1 fracture treated either surgically or~          conservatively and healthy control persons.~        -  To determine the relationship between passive ankle range of motion, lower leg muscle~          strength and dynamic ankle range of motion.~        -  To determine the relationship between lower leg muscle strength and balance.~        -  To determine the relationship between dynamic range of motion and the Foot and Ankle~          Outcome Score.~   "
2126|NCT03539016|"~     The study was conducted to observe the clinical features during pregnancy in women with~     chronic hepatitis B virus infection and mother-to-child transmission of hepatitis B virus.~   "
2127|NCT03539003|"~     The purpose of this study is to compare the changes of QTc, Tp-e interval, and Tp-e/QT ratio,~     Tp-e/QTc ratio on the ECG during robotic-assisted laparoscopic radical prostatectomy under~     sevoflurane, desflurane and total intravenous anesthesia~   "
2128|NCT03538990|"~     The objective of the study is to examine the effect of nutritional intake on hemodynamic,~     cardiometabolic, and inflammation markers in advanced heart failure patients with implanted~     hemodynamic monitoring device (CardioMEMS), using a one-group pre-post test design feeding~     trial. The pre-test condition is represented by participants' self-selected diet, and the~     post-test condition is represented by a prescribed Dietary Approaches to Stop Hypertension~     (DASH) diet.~   "
2129|NCT03538977|"~     Premature newborns (PTNB) often develop bronchopulmonary dysplasia (BPD) which can be related~     to an inability to maintain differences in tonus patterns (extensor and flexor) between the~     cervical muscles, upper and lower limbs. Babies who develop BPD remain in the neonatal~     intensive care unit (NICU) for a prolonged period of time, undergoing a large number of~     painful procedures. Exposure to pain in premature newborns (PTNB) is one of the most damaging~     factors in the extrauterine environment, also causing stress, which can also interfere with~     tonus pattern. Therefore, the aim of this study is to evaluate the effects of hydrotherapy on~     muscular activity, pain, sleep and wakefulness, stress, physiological conditions and the need~     for oxygen in PTNB with BPD during hospitalization in the neonatal unit. EXPECTED RESULTS:~     Hydrotherapy is expected to relieve pain, improve sleep quality and reduce oxygen therapy and~     ventilatory support in hospitalized PTNB babies with BPD.~   "
2130|NCT03538964|"~     Comparison of the astigmatism reducing effect of a toric IOL with a non toric IOL in eyes~     with low corneal astigmatism.~   "
2131|NCT03538951|"~     This is a Phase 2 clinical study in patients with actinic keratosis involving daily~     application of 1 of 2 strengths of VDA-1102 topical ointment for approximately 12 weeks (84~     days). This study has no placebo and the subjects enrolled in the study will know exactly~     what they are receiving. The objectives of the study are to evaluate the safety and benefit~     of these two strengths.~   "
2132|NCT03538938|"~     This study seeks to evaluate ways to improve outcomes for low-education, uninsured or~     Medicaid-eligible smokers who do not successfully quit with standard telephone quit line~     treatment. The study will use an efficient factorial study design to evaluate four~     evidence-based strategies to improve follow-up care offered by the Wisconsin Tobacco Quit~     Line (WTQL) to socioeconomically disadvantaged callers who report smoking four months~     following initial WTQL treatment comprising a single counseling call and 2-week supply of a~     single nicotine replacement therapy. These strategies include: increasing the intensity of~     nicotine replacement medication (among those medically cleared to use such medications),~     increasing the intensity of WTQL counseling, helping callers enroll in an evidence-based~     smoking cessation texting support program (SmokefreeTXT), and offering moderate financial~     incentives for engagement in counseling and SmokefreeTXT.~   "
2135|NCT03538899|"~     This study aims to determine if a new method can be used to treat Artemis-deficient Severe~     Combined Immunodeficiency (ART-SCID), a severe form of primary immunodeficiency caused by~     mutations in the DCLRE1C gene. This method involves transferring a normal copy of the DCLRE1C~     gene into stem cells of an affected patient. Participants will receive an infusion of stem~     cells transduced with a self-inactivating lentiviral vector that contains a normal copy of~     the DCLRE1C gene. Prior to the infusion they will receive sub-ablative, dose-targeted~     busulfan conditioning. The study will investigate if the procedure is safe, whether it can be~     done according to the methods described in the protocol, and whether the procedure will~     provide a normal immune system for the patient. A total of 15 patients will be enrolled at~     the University of California San Francisco in this single-site trial, and will be followed~     for 15 years post-infusion. It is hoped that this type of gene transfer may offer improved~     outcomes for ART-SCID patients who lack a brother or sister who can be used as a donor for~     stem cell transplantation or who have failed to develop a functioning immune system after a~     previous stem cell transplant.~   "
2136|NCT03538886|"~     The Nordic-Baltic Heart Team Initiative for improved long-term coronary artery~     revascularization outcome compares quality of life and survival after coronary bypass~     grafting (CABG) vs. percutaneous coronary intervention (PCI) in patients with 1-vessel~     disease and proximal stenosis of the anterior descending artery (LAD/in patients with~     isolated proximal left descending coronary artery (LAD) lesion~   "
2137|NCT03538873|"~     Considering the rapid increase of the elderly population in Brazil and the growing impact of~     depression, the third cause of global burden of diseases in the world, the relevance of~     depression prevention and treatment in older people tend to raise in future years. The~     investigators planned to screen 2,700 individuals, 60 years and older, from Basic Health~     Units in the west region of Sao Paulo city, for subsyndromic depressive and / or anxiety~     symptoms. The elderly will be assessed with a standardized psychiatric interview to calculate~     the prevalence of subsyndromic symptoms of depression and / or anxiety and the prevalence of~     depressive and anxiety disorders. Those who do not meet criteria for depressive disorders and~     / or anxiety will be invited to participate in a randomized clinical trial with 2 arms: a~     stepped-care prevention program with physical activity (n = 35) or usual care (n = 35). The~     primary outcome measure will be the cumulative incidence of major depressive disorder, or~     anxiety disorders, after 12 months.~   "
2138|NCT03538860|"~     There is a pressing national need to provide higher-quality, more effectively accessible~     language interpretation services to improve the health outcomes of Americans who have limited~     English proficiency (LEP). This project addresses a critical component of this problem: The~     need to improve access to high quality, mental health services for diverse populations by~     improving the flow of clinical work across care settings (primary care and specialty care)~     through the use of innovative online asynchronous methods of language interpretation and~     clinical communication. The investigators are conducting a two phase study. The first phase~     is completed and involved developing and testing the interpreting tool. The second phase of~     the research is a clinical trial to compare two methods of cross-language psychiatric~     assessment.~   "
2139|NCT03538847|"~     Postoperative pain (POP) is frequently underestimated in general and little data are~     available particularly for POP after vitreoretinal surgery (VRS). The investigators will~     conduct a 1-year retrospective study on patients undergoing VRS at Careggi Hospital . The~     aim of the study will be to observe the amount of POP, its time course, factors associated~     with its appearance and finally the efficacy of the pain protocol that is in use.~   "
2140|NCT03538834|"~     A high intake of fish is associated with positive health effects, including prevention and~     treatment of chronic non-communicable diseases, such as cardiovascular diseases (CVDs) and~     type 2 diabetes. These health effects have traditionally been attributed to the omega-3 fatty~     acids in fatty fish, but recent studies have suggested that also fish proteins may improve~     biomarkers of metabolic disease. Intake of cod fillet have previously shown beneficial~     effects on blood lipids, glucose regulation and body composition in adults with overweight or~     obesity. Health effect of cod residual material from fillet production (i.e., head, backbone,~     skin, cutoffs and entrails) have so far not been investigated, but residuals from other fish~     species have shown promising effects on glucose regulation in rats. The main aim of the~     current study is to investigate the effects of protein from cod fillet and cod residuals on~     serum lipids and glucose regulation in healthy, physically active adults.~   "
2141|NCT03538821|"~     A high intake of fish is associated with positive health effects, including prevention and~     treatment of chronic non-communicable diseases, such as cardiovascular diseases (CVDs) and~     type 2 diabetes. These health effects have traditionally been attributed to the omega-3 fatty~     acids in fatty fish, but recent studies have suggested that also fish proteins may improve~     biomarkers of metabolic disease. Intake of cod fillet have previously shown beneficial~     effects on blood lipids, glucose regulation and body composition in adults with overweight or~     obesity. Health effect of cod residual material from fillet production (i.e., head, backbone,~     skin, cutoffs and entrails) have so far not been investigated, but residuals from other fish~     species have shown promising effects on glucose regulation in rats. The main aim of the~     current study is to investigate the effects of protein from cod fillet and cod residuals on~     serum lipids, glucose regulation and inflammatory markers in healthy overweight or obese~     adults.~   "
2142|NCT03538808|"~     The current study will use the double-blind balanced placebo design to examine differences~     between expectancies versus the pharmacological effects of varenicline medication~     administered for two weeks to cigarette smokers. The double-blind balanced placebo design~     includes medication administration (active medication v. placebo) and medication information~     (told truth v. deception) resulting in four groups of smokers: (1) told therapeutic dose (TD)~     medication + received TD medication; (2) told TD medication + received placebo; (3) told low~     dose (LD) medication+ received TD dose medication; (4) told LD medication + received placebo.~     Ecological momentary assessments (EMA) in the form of Daily Dairies delivered via smartphone~     will assess real-time side effects, withdrawal symptoms, cigarettes smoked, medication use,~     and reasons for medication non-adherence.~   "
2143|NCT03538795|"~     This pilot study will examine a combination therapy for adults with chronic, severe motor~     impairment of an arm after stroke. The intervention will combine brain stimulation with~     physical rehabilitation of the arm on the side of the body more-affected by stroke.~   "
43676|NCT02995109|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
2145|NCT03538769|"~     Acute kidney injury (AKI) is a common clinical event with severe consequences. In the United~     States alone, greater than one million hospitalized patients per year are diagnosed with AKI.~     It has been independently associated with prolonged hospital stays, 25-80% risk of~     in-hospital death, and future progression to chronic kidney disease. While there has been an~     increase in awareness about the prevalence and significance of AKI, studies have uncovered~     systematic failure in the management of AKI, largely relating to the failure of clinicians to~     recognize and manage the condition appropriately. This is where we can use electronic health~     records (EHRs) and electronic alerts (e-alerts) to our advantage. In this study, the~     investigators plan to use e-alerts integrated into a clinical decision support (CDS) system~     to improve the care of and outcomes of patients with AKI. The aims are to study the~     prevalence of AKI and its progression among hospitalized patients using an 'AKI sniffer' (an~     EHR based automated system) and to prospectively study if introducing a complex intervention~     (an e-alert combined with a clinical decision support system) will reduce progression of AKI~     in children. The investigators have developed an AKI care bundle which provides simple~     guidelines for management of AKI along with specific discharge instructions to improve follow~     up care. The primary outcome is AKI progression. Secondary outcomes include morbidity,~     mortality, length of hospital stay, need for renal replacement therapy, and recovery of renal~     function by time of hospital discharge. The investigators will also look at documentation of~     AKI and if these participants get appropriate follow up.~   "
2146|NCT03538756|"~     The purpose of this study is to investigate the long-term effects of walkasins® use on~     clinical and subject-reported outcomes of balance and gait function, quality of life,~     physical activity/participation, pain, and medication use in persons with peripheral~     neuropathy who experience balance problems.~   "
2147|NCT03538743|"~     This is a dose-escalating study in patients with Type 2 diabetes on metformin. Participants~     will receive an investigational product or placebo for 28 days.~   "
2148|NCT03538730|"~     Pain is a common experience in childhood. Healthy children can undergo up to 20 painful~     procedures by the age of 5. Moreover, millions of children undergo surgery (e.g.,~     tonsillectomies) each year, which is commonly linked to pain and distress. Pain from, and~     fear of, medical experiences are not short lasting. Indeed, they can influence children long~     after the painful situation is over. Children's memories of pain after surgery can affect~     painful experiences in the future. Negative memories of pain (when children remember more~     pain than the actual level of pain experienced) are linked to higher pain and distress. As~     well, children who are more anxious and who experience greater pain are more likely to~     develop negatively biased pain memories, which then leads to greater fear and pain at~     subsequent pain experiences. It has been suggested that the ways in which parents and~     children talk about pain following painful events is important for how children remember the~     pain.~      This study will be one of the first to look at whether a parent-led memory reframing~     intervention can reduce children's negative memories of surgery.~      The study will include 100 children scheduled for a tonsillectomy and one of their parents.~     They will be recruited from the Alberta Children's Hospital. Parents will complete a survey~     1-3 weeks before their child's surgery, and then the child's pain and anxiety will be~     monitored on the day of surgery and for 2 weeks after surgery. Two weeks after surgery, the~     parent and child will come to the hospital and be assigned to a control group or a memory~     reframing session. Six weeks after surgery, parents and children will complete a telephone~     interview.~   "
2149|NCT03538717|"~     Retrospective study to collect data from Patients with advanced/metastatic renal cell~     carcinoma previously treated with Axitinib under standard clinical practice, to describe the~     clinical profile of the patients with a long response to Axitinib and to try to identify~     clinical factors which could be related with the long response to Axitinib, through the~     comparison between long responder patients and a group of refractory patients~   "
2150|NCT03538704|"~     The purpose of this study is to investigate the effect of Fertility-sparing Therapy of Early~     Endometrial Cancer.~   "
2151|NCT03538691|"~     Major depressive disorder (MDD) is a serious medical illness associated with significant~     suicidal risk and marked disability. Despite the availability of numerous treatments,~     achievement of consistent and favorable long-term outcomes remains challenging.~      This study will assess the safety, efficacy and tolerability of brexpiprazole as adjunctive~     therapy to protocol-specific open-label antidepressant therapy.~   "
2152|NCT03538678|"~     The intervention will be use of a smartphone app to support tobacco cessation. The app's main~     features include sending motivational messages, displaying money saved, and allowing the user~     to log cravings.~   "
2153|NCT03538665|"~     Background:~      Endometrial cancer is a common and deadly cancer for women. It is getting more common and~     deadly because risk factors like age and obesity are increasing. It is highly curable if it~     is identified early. But there may be no symptoms early or they may be missed. Also, this~     cancer is becoming more common and deadly for black women than white women. Researchers want~     to find better ways to take samples and test them for this cancer. They want to study this~     for a racially diverse population. One way to take samples might be from a tampon.~      Objective:~      To see if it is possible and acceptable to collect an endometrial sample from women by using~     a tampon placed in the vagina.~      Eligibility:~      Women at least 45 years old who are having a hysterectomy~      Design:~      Participants will put a tampon in their vagina at least 30 minutes before their surgery.~      Participants will take a short survey.~      The tampon will be collected during the surgery.~      A small piece of tissue will be collected from the uterus that is removed in surgery.~      Participants will give a blood sample.~      Before or after surgery, participants will answer questions. These will be about their~     medical history and basic data such as age and race.~      Researchers will follow participants medical records for up to 3 years after the study.~      Researchers will study the samples and tampons. They will compare how well cancer and other~     markers are detected between the samples....~   "
2170|NCT03538431|"~     This study will examine the effects of treatment with the anti-anxiety medicine buspirone on~     driving performance (eye tracking) in individuals with high-functioning autism spectrum~     disorder (HF-ASD).~      The study consists of an Assessment Visit at Massachusetts General Hospital (MGH), as well as~     two Driving Simulation visits that will take place at Massachusetts Institute of Technology~     (MIT). Subjects will be given buspirone and asked to take the medication for the two days~     preceding the Driving Simulation Visit.~   "
2154|NCT03538652|"~     Background:~      Many smartphone apps intend to help people with addictions. But not enough is known about how~     they should work. Researchers want to study an app that gives people the advice they need,~     just when they need it. This is a JITAI. It stands for Just-In-Time Adaptive Intervention. To~     create a good JITAI, researchers need to know what approaches work best at different moments.~      Objective:~      To develop ways to treat addiction with a smartphone app.~      Eligibility:~      Adults ages 18-75 who use heroin or other opioids~      Design:~      Participants will be screened in another protocol.~      Participants will visit a Baltimore clinic 3 days a week to give urine and breath samples.~      Some participants will get their treatment at this clinic.~      Participants will answer questions about their personality and stress.~      Participants will randomly be assigned to the JITAI group or a comparison group.~      Participants will have a training session on using the smartphone app. JITAI participants~     will also watch a video about the written messages they ll see in the app.~      Weeks 3-10: participants will carry a smartphone. Four times a day, it will beep and ask~     questions. These will be about the participant s activities and mood. The JITAI group will~     see a short message after. The message is meant to be helpful.~      For the first 16 evenings, JITAI participants will get more information on the phone.~      Answers to the app s questions will be transferred automatically from the smartphone to~     secure computers at the NIH.~      During the last week, participants can choose the kind of messages they see.~      Week 11: participants will return the smartphone and answer questions.~      Weeks 12-16, participants who are getting their medicine from the research clinic will be~     encouraged to transfer to other clinics. Otherwise, they will have their dose slowly reduced~     to zero.~   "
2155|NCT03538639|"~     Background:~      Some genetic diseases put increase the risk of heart and blood diseases, which are the number~     one cause of death and disability in the U.S. Researchers want to study diseases of the heart~     and/or blood vessels. They want to collect data and specimens from affected people, their~     family members, and healthy people.~      Objective:~      To study diseases of the heart and/or blood vessels.~      Eligibility:~      People age 2 and older who may have genetic disease affecting the heart and/or blood vessels~     Their relatives~      Healthy volunteers~      Design:~      Participants will be screened with a medical history, physical exams, and imaging tests.~     Participants may have a few visits or visits for 2 weeks or more. This will depend on their~     age and disease status. Visits may include:~      Photographs of the face and body~      Heart tests~      Samples taken of blood, urine, saliva, skin, and/or tissue~      Scans. For some, a dye may be injected into a vein.~      A six-minute walk test~      Lung tests. For some, participants will blow into a tube. For others, they will breathe in a~     gas from a mask, have a small injection, then have a scan.~      Stress tests while walking on a treadmill or riding a stationary bike~      Ultrasound of veins and arteries~      Devices outside the body testing the stiffness and function of arteries~      Eye exam and eye tests. For some, a dye may be injected in a vein.~      Blood pressure tests~      Measurements of blood flow under the skin and in the arms and fingernail blood vessels~      Devices outside the body testing flexibility of the blood vessels and skin, and skin~     temperature...~   "
2156|NCT03538626|"~     Background:~      Human Immunodeficiency Virus (HIV) infection is a serious disease. It has no cure or vaccine~     to prevent it. Using antibodies is one way to prevent HIV infection that seems promising.~     Antibodies are naturally made by the body to fight germs so people stay healthy. Researchers~     want to see if the antibody N6LS, made artificially in the lab, can prevent HIV infection.~      Objective:~      To see if the antibody N6LS is safe and well-tolerated.~      Eligibility:~      Healthy people ages 18 50~      Design:~      Participants will be assigned to 1 of 6 groups.~      Group 1 4 participants will have about 13 visits over about 24 weeks. They will get N6LS~     once.~      Group 5 6 participants will have about 26 visits over about 48 weeks. They will get N6LS 3~     times.~      Visits that involve receiving N6LS may be up to 8 hours. Follow up visits are about 30~     minutes. Female participants will have pregnancy tests at each one.~      Some participants will get N6LS through a thin tube in an arm vein. A pump will give N6LS~     directly into the vein for about 30 minutes. A tube in a vein in the other arm will collect~     blood.~      Some participants will get the antibody as an injection into the fatty tissue of the belly,~     arm, or thigh.~      Participants will have blood taken at every visit.~      Participants will get a measuring tool and thermometer. They will check their temperature~     every day for 3 days after they get N6LS. They will check the injection site and measure any~     redness, swelling, or bruising.~      Non-N6LS visits will be about 2 hours. Participants will report any health changes and how~     they have been feeling.~   "
2157|NCT03538613|"~     Background:~      The gene CISH can weaken immune cells called lymphocytes. It is found in all cells of the~     body but it most negatively impacts lymphocytes. This study may help people with certain~     cancers.Lymphocyte cells will be taken from their tumors, the CISH gene will be removed from~     those cells, then the cells will be returned to the person. Researchers hope this process~     will help the cells work better and fight the tumors.~      Objective:~      To see if cells with the CISH gene removed are safe and shrink metastatic gastrointestinal~     epithelial tumors.~      Eligibility:~      People 18 70 years old with metastatic gastrointestinal epithelial cancer~      Design:~      Participants will be screened with physical exam, scans, and heart, lung, blood, and urine~     tests.~      Participants will have cells collected in another protocol. They must tell their doctor of~     any antibiotic allergy.~      The cells will be changed in a lab. Participants will stop therapy 4 6 weeks before getting~     the cells back.~      Participants will have leukapheresis. Blood is sent by a needle in one arm into a machine~     that takes out the white blood cells. The blood is returned through a needle in the other~     arm.~      Participants will have an IV catheter inserted in their upper chest to receive medicines and~     the cells.~      Participants will stay in the hospital and:~        -  Have chemotherapy for 1 week~        -  Get the cells for about a half hour to a little over an hour~        -  Get a cell growth medicine about every 8 hours for up to 12 doses~        -  Get medicines to boost blood cells and fight side effects~        -  Recover for 1 3 weeks.~      Participants will have 2 follow-up visits within 12 weeks of treatment, then a couple visits~     each year. They will repeat screening tests.~   "
2171|NCT03538418|"~     This study aims to investigate the feasibility, acceptability, and preliminary effects of a~     Wearable Activity Tracker (WAT)-based exercise intervention to increase physical activity~     levels in frail or pre-frail older people. One group of participants will receive a WAT-based~     exercise intervention incorporated with the support of behavioral change techniques (BCTs)~     and technical issues, while the other group will receive only an exercise intervention~     incorporated with BCTs support.~   "
2172|NCT03538405|"~     This study investigated the short-term effect of both harmonic techniques and supporting~     cushions on muscle tone, range of motion, pain and daily care activities in 22 patients with~     moderate to severe paratonia. The study consisted of two parts, each part was conducted~     during one week. In the first part of the study the short-term effect of supporting cushions~     was examined; in the second part of the study the additional short-term effect of harmonic~     techniques was investigated.~   "
2158|NCT03538600|"~     Background:~      The Laboratory of Immune System Biology (LISB) works with other labs at the National~     Institutes of Health. They study how parts of living things come together to make a whole.~     LISB designs and improves research tests on human samples like blood and cells. In order to~     do its work, LISB needs to have a lot of these samples available.~      Objective:~      To collect biological specimens to use for designing and improving research tests. Specimens~     include blood, stool, saliva, and skin/mucosal swabs.~      Eligibility:~      Healthy people ages 18-70~      Design:~      Participants will be screened with an interview about their general health and their medical~     history. They will have a physical exam and blood tests.~      If the results of the screening are normal, participants will be asked to give one or more of~     these samples:~      Blood will be drawn from an arm vein with a needle and syringe.~      Mucus and skin will be collected by rubbing the area with a cotton swab. The areas may~     include the top of the tongue, inside the cheek, nostrils, behind the ear, elbow pit, or~     vagina.~      Participants will spit into a tube to collect saliva.~      Participants will pass stool into a plastic container that fits in the toilet under the seat.~     They will get sampling kits and instructions.~      Over the next 5 years, if more samples are needed, participants will be contacted to set up~     another visit to the NIH. These visits will each take about 1 hour.~      About every 2 years, when participants come to NIH for a visit, extra blood will be~     collected. It will be tested for HIV and hepatitis B and C.~   "
2159|NCT03538587|"~     Background:~      People cope with cancer in different ways. Mindfulness means focusing on the present moment~     with an open mind. Researchers want to see if this can help children with high-grade brain~     tumors and their caregivers.~      Objective:~      To learn if mindfulness is feasible and acceptable for young people with high-grade brain~     tumors and their caregivers.~      Eligibility:~      Children ages 5 17 with a high-grade brain tumor, with a caregiver who agrees to do the study~      Must have internet access (participants may borrow an iPod for the study)~      Must speak English~      Design:~      All participants will complete questionnaires. These will be about feelings, physical~     well-being, quality of life, and mindfulness.~      Researchers will review children s medical records.~      Participants will be randomly put in the mindfulness group or the standard care group.~      Participants in the standard care group will:~      Get general recommendations for coping with cancer~      Have check-in sessions 1 and 3 weeks after starting. These will last about 10 minutes each.~      After participants finish the standard care group, they may be able to enroll in the~     mindfulness group.~      Participants in the mindfulness group will:~      Attend an in-person mindfulness training session. The child participant will meet with one~     research team member for 90 minutes while the parent participant meets with another. Then~     they will come together for a half hour.~      Practice mindfulness exercises at least 4 days a week for 8 weeks.~      Be asked to respond to weekly emails or texts asking about their mindfulness practice~      Get a mindfulness kit with things to help them do their mindfulness activities at home.~      Have a 30-minute check-in with their coach 1 and 3 weeks after starting. This can be in~     person or by video chat.~      All participants (from both groups) will be asked to answer follow-up questions about 8 and~     16 weeks after starting the study. Participants will be paid $20 for each set of~     questionnaires they complete to thank them for their time.~   "
2160|NCT03538574|"~     Treatment of insomnia in caregivers is needed given that 60% of Alzheimer disease caregivers~     report sleep complaints, and insomnia may add to the burden of AD caregiving and contribute~     to morbidity and mortality risk. This is the first intervention trial in AD caregivers to~     target insomnia and also evaluate two mechanisms of chronic disease risk, inflammation and~     cellular aging~   "
2161|NCT03538548|"~     Cognitive-behavioral treatments for cocaine abuse could be improved by an increased~     understanding of factors that predict treatment outcomes. The objective of this protocol is~     to conduct a study examining the impact of client characteristics on the effects of~     cognitive-behavioral therapy for cocaine abuse.~   "
2162|NCT03538535|"~     This study will test a computational model reinforcement learning in depression and anxiety~     and test the extent to which the computational model predicts response to an adapted version~     of behavioral activation psychotherapy. The model will be based on a data from a computer~     task of reinforcement learning during 3T functional magnetic resonance imaging at baseline.~   "
2163|NCT03538522|"~     This study seeks to evaluate the efficacy and safety of NA-83 in subjects with mild cognitive~     impairment due to Alzheimer's Disease~   "
2164|NCT03538509|"~     This is a retrospective, multicenter, study including patients undergone to one or more~     percutaneous revascularization after OHT. The rate of restenosis, the kind of percutaneous~     revascularization, the feature of coronary disease and the medical therapy for positive~     vessel remodeling will be evaluated.~   "
2165|NCT03538496|"~     Erector Spinae Plane Block (ESPB) is a newly described and effective interfascial plane block~     for thoracic and abdominal surgery. It was first described by Forero et al. in 2016,~     effectiveness being reported in four cases. The paravertebral block has been successfully~     used in various surgical patient groups for purposes of anesthesia or postoperative pain~     management such as thoracotomy, breast surgery and abdominal surgery. The aim of this study~     is to compare the analgesic effects of erector spinae plane block and paravertebral block in~     patients undergoing video assisted thoracoscopic surgery.~   "
2166|NCT03538483|"~     Serratus plane block (SPB) was first described in 2013 by Blanco and designed to primarily~     block the thoracic intercostal nerves. And this block provides sufficient analgesia lateral~     anterior and posterior part of thoracic wall.Erector Spinae Plane Block (ESPB) is a newly~     described and effective interfascial plane block for thoracic and abdominal surgery. It was~     first described by Forero et al. in 2016, effectiveness being reported in four cases. The aim~     of this study is to compare Serratus plane block and erector spinae plane block on~     postoperative pain in patients undergoing modified radical mastectomy and axillary lymph node~     dissection~   "
2167|NCT03538470|"~     1. Primary outcome measure: measuring the effect of spa treatment in patients suffering~          from lower limb osteoarthritis or any other lower limb rheumatological condition.~           Percentage of patients with minimum 19,9 mm decrease in pain Visual Analogue Scale (VAS)~          or WOMAC score (Western Ontario and McMaster Universities Arthritis Index) increase of~          at least 9 points (minimal clinically important difference), 6 months after enrollment.~           Secondary outcome measures:~        2. Measuring the effect of spa treatment in patients with concomitant chronic lower back~          pain.~           Percentage of patients presenting clinical benefits according to the EIFEL score, with a~          decrease of at least 5 points, 6 months after enrollment.~        3. Quantitative evaluation of pain. Mean pain VAS comparison between enrollment and 6~          months after spa treatment.~        4. Quantitative evaluation of WOMAC score. Mean WOMAC score comparison between enrollment~          and 6 months after spa treatment.~        5. Quantitative evaluation of EIFEL score. Mean EIFEL score comparison between enrollment~          and 6 months after spa treatment.~        6. Impact of spa treatment on the patient's metabolism. Height and weight (BMI~          calculation), blood pressure and heart rate measured at enrollment and throughout the~          follow-up.~        7. 8. Quality of life. 36-Item Short Form (SF 36) and EuroQol 5 Dimensions (EQ5D)~          questionnaires at enrollment, 3 months and 6 months.~      9. Doctor and patient opinion. Semi-quantitative scale collected at enrollment, 3 months and~     6 months.~      10. Medicine consumption Daily medicine consumption evaluated upon the 72 hours preceding the~     medical visit at enrollment, 3 months and 6 months.~      11. Auto-evaluation of pain VAS pain evaluation by the patient every 6 weeks for a more~     precise time frame of the treatment's effect.~   "
2168|NCT03538457|"~     Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the~     pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the~     pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery.~     Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological~     availability of medication. In this study the pharmacokinetic effects of bariatric surgery on~     paracetamol are investigated.~   "
2174|NCT03538379|"~     Trauma is the leading cause of death for individuals ages 1-45 years old, within this cohort,~     and uncontrolled hemorrhage is the leading cause of preventable death.1,2 Tourniquets have~     been shown to be effective in dramatically decreasing death from uncontrolled hemorrhage on~     the battlefield and there is level 4 evidence that EMS application of tourniquets in the~     civilian sector is effective though not to the same degree as in the military.3,4 Multiple~     national groups have advocated that to further decrease preventable deaths from hemorrhage,~     laypersons should apply tourniquets before the arrival of professional first responders. To~     this aim, the Stop the Bleed campaign has trained over 100,000 individuals in the US in~     hemorrhage control techniques and tourniquet use with the Bleeding Control Basic (B-Con)~     course.5 The Stop the Bleed campaign informs course participants all commercial tourniquets~     are equivalent, and improvised tourniquets should be applied if a commercial tourniquet is~     not available.6 The investigators are evaluating the ability of the B-Con course participants~     to apply three different types of commercial tourniquets, the Rapid Application tourniquet~     (RAT), the Stretch-Wrap-And-Tuck tourniquet (SWAT-T), and the Sof Tourniquet (Sof-T) as well~     as participants ability to fashion an improvised tourniquet. The investigators hypothesize~     B-Con in its current form does not enable course participants to apply other commercial~     tourniquets beyond the specific one taught, the CAT tourniquet, and does not teach how to~     apply an improvised tourniquet.~   "
2175|NCT03538366|"~     Patients with chronic pouchitis are treated with fecal transplant from several unrelated,~     healthy donors. The treatment consists of enemas of 100 mL fecal suspension, applied for 14~     consecutive days.~   "
2176|NCT03538353|"~     The overall goal of this single session semi-structured interview project is to explore the~     validation and contradiction of the preexisting pain beliefs in patients with chronic pain.~      Aim 1: After patients watch an educational video, explore occurrences of perceived validation~     and contradiction and the impact of validation and contradiction on pain beliefs, emotion,~     and pain.~      Aim 2: Obtain patients' recommendations for improving the educational value of the video.~   "
2177|NCT03538340|"~     The ICE Study study will compare standard therapy (thoracic epidural) versus a novel approach~     (Cryoanalgesia combined with thoracic epidural) in subjects undergoing unilateral~     thoracotomy.~   "
2178|NCT03538327|"~     Background: Hypertensive patients with normal glucose tolerance (NGT) but 1-h post load~     plasma glucose >155 mg/dl (1-h high), during the oral glucose tolerance test (OGTT), show an~     unfavorable metabolic profile characterized by higher insulin resistance (IR), subclinical~     inflammation and multiple target organ damage. Experimental and clinical studies have~     demonstrated that silybin presents important anti-inflammatory and metabolic effects,~     improving IR and endothelial dysfunction. The present study aims to evaluate the effects of~     the complex silybin-vitamin E and phospholipids on inflammatory, metabolic and vascular~     parameters in NGT 1-h high hypertensive patients.~      Methods: This is a pilot, single arm, interventional, longitudinal study in which the~     investigators have planned to enroll 50 Caucasian never-treated hypertensive outpatients,~     showing normal glucose tolerance but 1-h post load plasma glucose >155 mg/dl, during the~     OGTT.~   "
2179|NCT03538314|"~     UV1 is a therapeutic cancer vaccine that has been explored in prostate and lung cancers, and~     in combination with ipilimumab in malignant melanoma. This study will explore the safety,~     tolerability and efficacy of UV1 administered with GM-CSF in melanoma patients who are also~     receiving pembrolizumab.~   "
2180|NCT03538301|"~     This phase 2 clinical study will be a randomized, double-blind, placebo-controlled,~     multicenter study to evaluate the safety, tolerability, biological activity, and~     pharmacokinetics (PK) of ND-L02-s0201 for Injection in subjects with IPF.~   "
2181|NCT03538288|"~     This small pilot trial will recruit 10 cannabis use disordered participants and apply 20~     sessions of rTMS in conjunction with a two session Brief Marijuana Dependance Counseling~     treatment paradigm. The investigators are primarily seeking to determine if the proposed~     paradigm is feasible and well tolerated.~   "
2182|NCT03538275|"~     An objective measure of treatment response could be a valuable new tool in the armamentarium~     of depression management, and this holds true for stimulation-based and pharmacological~     therapies alike. Hence, the Medibio Depression Monitoring Study will use the Medibio~     analytics platform to characterize autonomic, circadian, and sleep patterns before and during~     the initial 8 weeks of pharmacologic therapy for moderate-to-severe depression. The study~     will also explore any differences in these measures between treatment responders and~     non-responders, and between depression subtypes, including bipolar and unipolar depression.~     The study will also characterize longitudinal, ambulatory EEG measures throughout the~     observation period.~   "
2183|NCT03538262|"~     An observational study to characterize and compare long-term clinical outcomes data collected~     remotely through periodic tele-visits, interactive smartphone app sessions, and web-based~     surveys in individuals with Parkinson's Disease (PD) who have completed the interventional~     phases of the STEADY-PD3 and SURE-PD3 clinical trials.~   "
2184|NCT03538249|"~     Heart failure (HF) is a major public health problem. This is the first cause of~     hospitalization and mortality of about 65 years old. This syndrome is characterized by a poor~     prognosis and a high cost of care. Thus, new strategies for treatment and prevention of the~     HF are among the major challenges facing health sciences today.~      The management of HF requires multimodal approach it involves a combination of~     non-pharmacological and pharmacological treatment, Besides improvements in pharmacological~     treatment, supervised exercise programs are recommended for all patients with HF as part of a~     non-pharmacological management but many questions regarding exercise training in HF patients~     remain unanswered. Even simple questions such as the best mode of training for these patients~     are unclear.~      The aim of this study~        1. First, to characterize the physiological functions involved in the genesis of exercise~          intolerance and dyspnea especially muscle function (respiratory and skeletal), and~          cardiopulmonary patients suffering from chronic HF.~        2. Second, to study and compare the effects of different rehabilitation programs and prove~          the superiority of the combination of three training modalities program: aerobic~          training (AT), resistance training (RT) and inspiratory muscle training (IMT).~      These modalities are:~      Aerobic Training: It has been proven effective in improving muscle abnormalities on changing~     the ventricular remodeling, dyspnea, functional capacity, increasing the maximum performance~     and reducing hospitalization in subjects suffering HF.~      Resistance Training: It has been proven effective in improving skeletal muscle metabolism and~     angiogenesis; increasing capillary density and blood flow to the active skeletal muscles,~     promoting the synthesis and release of nitric oxide, and decreasing oxidative stress.~      Selective Inspiratory Muscle Training: It has been proven effective in improving the strength~     and endurance of the respiratory muscles and reduction of dyspnea during daily activities.~   "
2185|NCT03538236|"~     The primary objective of this study is to assess efficacy of intragastric balloon for weight~     loss in obese patients who also concurrently have NASH.~   "
2434|NCT03534973|"~     Investigate if caffeine accumulation in human lens epithelial cells after oral caffeine~     intake is sufficient to prevent from experimental ultraviolet radiation induced apoptosis~   "
2186|NCT03538223|"~     Music and music therapy are now widely used as non-pharmacological intervention techniques in~     different clinical and therapeutic settings.~      The present study includes the use of musical listening related to the concept of Music~     Medicine, a possibility of modifying the psycho-physiological state of the patient through~     the targeted use of musical pieces respondent to specific parameters and musical structures~     able to interact in particular conditions with the psycho-somatic imbalances to which the~     person is subjected.~      In particular, in this study, in addition to proposing a traditional listening method, the~     music used in one of the research arms will be composed of an artificial intelligence called~     Melomics-Health.~      The objective of the study is to verify whether the perception of anxiety and stress in~     cancer patients undergoing Radiotherapy is influenced by music listening (Melomics-Health~     music vs listening to favorite music). Sixty breast cancer surgical patients, candidates for~     post-operative radiotherapy with a healing purpose. Patients who will undergo Radiation~     therapy for the first time in their lives will be included.~      Patients will be recruited in this randomized controlled study with a sequential enrollment~     and, in the case of inclusion, will be assigned to one of the following 3 groups: a)~     Melomics-Health music listening group (n = 20); b) favorite music listening group (n = 20);~     c) no-music control group (n = 20). Music groups will undergo 15 minutes music listening~     immediately before the simulation and the first 5 sessions of radiotherapy.~      Patients will be subjected to a psychological assessment focused on anxiety (State-Trait~     Anxiety Inventory) and distress (Psychological Distress Inventory) dimensions at the baseline~     (T0), at the end of the treatments (T1) and at the Follow-up (T2, 2 weeks after the fifth~     session of Radiotherapy). A specific questionnaire will also be submitted to the patients~     included in music groups. This questionnaire will allow the music therapist to acquire~     specific qualitative information regarding the different types of music listening and the~     responses of the subjects to them.~      Descriptive statistics will be produced for all the variables detected.The effectiveness of~     musical listening in relation to the psychological aspects considered will be evaluated by~     applying analysis of variance models.~   "
2187|NCT03538210|"~     Obesity prevalence rapidly increased in the past decades in French population with multiple~     health consequences responsible for excess mortality. In the same period of time, the number~     of bariatric procedures have developed exponentially. Despite its great efficacy on weight~     loss but also on resolution of comorbidities, bariatric surgery is not without risks. Our~     hypothesis is that a better understanding of the physio-pathological consequences of obesity~     and bariatric surgery, notably on the gastrointestinal tract, may allow to improve the~     treatment of obesity and to find alternatives to bariatric surgery.~      The main objective of this cohort study is to systematize the collection and the conservation~     of biological samples (blood, stomach, liver, intestine, adipose tissue) obtained during~     bariatric surgery, in obese subjects undergoing surgery (including sleeve gastrectomy,~     Roux-en-Y gastric bypass, or revisional intervention for complication or weight regain) in~     the University Hospital group of Paris Nord Val de Seine (HYPNVS).~      The main projects that will build on this cohort will cover the physiopathology of obesity~     and its consequences, notably in the field of gastrointestinal tract including: modification~     of gastro-intestinal plasticity in severe obesity and after bariatric surgery and alterations~     of absorption of nutriments (lipids, proteins, carbohydrates) induced by obesity and~     bariatric surgery. The inclusion in this project of obese subjects before surgery, or lean or~     obese subjects after surgery will allow to distinguish the impact of weight loss and surgery~     on gastrointestinal remodeling. This cohort will also allow to characterize stomach and~     intestinal proteome in severe obesity and to precise the influence of tissue inflammation on~     metabolic disorders associated with obesity.~   "
2188|NCT03538197|"~     Suicide is the second leading cause of death among people aged 15 to 24 (WHO, 2014). After a~     first suicide attempt, the 18 to 25 years old would be very likely to repeat the act: 25 to~     31% would make a new attempt in the following year (Christiansen et al, 2007).~      Nevertheless the literature on this subject is not detailed. In this project, we hypothesize~     that young adults aged 18 to 25 who have made their first suicide attempt will repeat their~     act more frequently than younger or older populations. In addition, these young people would~     have identifiable risk factors (sociodemographic, clinical and biological) that differ from~     young people who do not enter this phenomenon.~      Our main objective is to measure the rate of suicidal reiteration in a population of young~     adults aged 18 to 25 years.~      Our secondary objectives are to identify sociodemographic, clinical and biological~     characteristics of a population of suicidal re attempt young people, to highlight potential~     risk factors~   "
2189|NCT03538184|"~     This study aims to evaluate the levels of cytokines, chemokines and growth factors in~     peri-implant sulcular fluid (PISF) during healing and osseointegration at osteotomy sites~     prepared either with piezosurgery (PS) or drills (D). Fourteen patients having bilateral~     partial edentulism in the posterior maxilla were enrolled and 38 osteotomies were prepared.~     Implants were placed with one-stage surgery. Insertion torque, early healing index, probing~     depth and modified gingival and plaque indices and crestal bone (CB) loss were measured. PISF~     was collected from 4 sites from each implant at weeks 2, 4, 8, 12 and 24. PISF samples were~     analysed by a 30-Plex immunoassay. Effect of time and osteotomy method on molecules employed~     Brunner-Langer method.~   "
2190|NCT03538171|"~     The purpose of this randomized phase III trial is to evaluate the clinical benefit of the~     addition of Entinostat to endocrine therapy (Exemestane) in Chinese patients with~     HR-positive, ER2-negative locally advanced or metastatic breast cancer who have previously~     progressed on a non-steroidal aromatase inhibitor (AI). In addition，the safety, tolerance and~     PK profile are evaluated.~   "
2191|NCT03538158|"~     The objectives of this study are to examine the usability and efficacy, for diverse older~     adults, of a new tablet-based dynamic system: the Fittle Senior System (FSS) that will~     provide: (1) personalized behavior-change programs for improved diet and increased physical~     activity and (2) online social interaction and support from small teams pursuing similar~     goals.~      The proposed study involves a two group randomized trial where participants will be~     randomized to the Fittle Senior System or to a paper-based psycho-educational control~     condition following a baseline assessment. The duration of the intervention phase will~     involve an active 12-week intervention phase followed by a 12-week maintenance phase. We will~     recruit and randomize 180 community dwelling adults aged 65+ years, who live alone and are at~     risk for social isolation. Participants will be assessed at baseline, 3mths post active~     intervention and 3mths post maintenance (6mths following active intervention) on measures of~     health and health behaviors, and indices of social support.~   "
2192|NCT03538145|"~     This study will aim to translate the original RS-14 (English version) into traditional~     Chinese. It will then test the psychometric properties of the newly translated RS-14 to~     examine its factorial structure using both exploratory factor analysis (EFA) and CFA.~   "
2193|NCT03538132|"~     The goal of this study is to collect the patients' opinion about the different types of bone~     graft, to assess which are the most rejected by the patients and if the demographic variables~     (such as the gender or the age) and the level of education influence their decision.~   "
3507|NCT03520959|"~     To assess if the CMB305 vaccine regimen may help the body's immune system to slow or stop the~     growth of synovial sarcoma tumor and improve survival.~   "
2194|NCT03538119|"~     The increase in the prevalence of cardiovascular diseases (CD), directly associated with the~     aging of the population, is a concern for public health in Portugal. Given the high~     prevalence of risk factors and the increasing number of cases of CD throughout Alentejo,~     where there is no cardiac rehabilitation (CR) coverage, there is an urgent need for the~     implementation of a CR program.~      CR has evolved over the past decades to multidisciplinary approaches focused on education,~     individualized training, modification of risk factors, and overall well-being of cardiac~     patients. Studies suggest that high intensity interval training (HIIT) allows greater patient~     benefits compared to moderate continuous training (MCT), reversal of DC and increased aerobic~     capacity in CR patients. This study intends to compare HIIT and MTC interventions~     investigating direct and indirect associations between informally performed physical activity~     (AF), sedentary behavior, cardiovascular fitness and quality of life (QoL) among patients~     enrolled in RC programs in phase III.~   "
2195|NCT03538106|"~     Introduction : Cesarean rate varies from 45% to 73% in the literature in patient with~     diabetes type 1. Having a prior C-section is the most important risk factor. The aim of this~     study was to identify risk factor of cesarean in this population.~      Methods: This study is an observational, retrospective and single-center study from the~     hospital of Montpellier. All the pregnancies, planned or not, with subcutaneous insulin~     infusion or multiple daily injections of insulin, in patients with diabetes type 1 between~     2009 and 2015, after 24 weeks of gestation were included. All the data were retrospectively~     collected by the principal investigator with computer and paper files.~   "
2196|NCT03538093|"~     The purpose of this study is to determine which type of lumbar stabilization exercise is more~     effective to improve functionality and reduce pain in patients operated with lumbar~     arthrodesis, to guide clinical practice in the rehabilitation of these patients.~   "
2197|NCT03538080|"~     Ultrasound marking of saphenous veins before varicose vein surgery or for saphenectomy for~     vascular or coronary artery bypass grafting is a long, tedious, low-grading examination,~     generating overconsumption of many consumables including marking markers that may damage the~     probes, of the modern and expensive ultrasound doppler. Augmented reality devices can~     visualize the superficial veins and hope to simplify the investigation, improve the comfort~     of the patient during the examination by significantly reducing the time of the examination.~     There is few data in the literature on the value of using augmented reality devices of this~     type. The AccuVein® system is a patient-friendly, non-contact, non-invasive technique that~     minimizes discomfort due to standing time and thus improves patient comfort.~   "
2198|NCT03538067|"~     This study will look at the effects of standardised balloon inflation times, pressure and~     balloon types and atherosclerotic plaque morphology on the procedural results of percutaneous~     coronary intervention (PCI).~   "
2199|NCT03538054|"~     The overall objective of this protocol is to evaluate if Dextromethorphan (DXM) can suppress~     symptoms associated with Fibromyalgia (FM). DXM is used in multiple over the counter cough~     suppressants. The investigators will be observing the effects of DXM on daily self-reported~     pain measures and activity within people who have fibromyalgia. If one of these medications~     help the symptoms of FM, it will give information about what is wrong in people with FM.~   "
2200|NCT03538041|"~     The purpose of this study is to evaluate the safety and efficacy of INCB050465 administered~     orally to participants with autoimmune hemolytic anemia (AIHA) who have decreased hemoglobin~     and evidence of ongoing hemolysis that requires treatment intervention.~   "
2201|NCT03538028|"~     The purpose of this study is to determine the safety, tolerability, and preliminary efficacy~     of INCAGN02385 in participants with advanced malignancies.~   "
2202|NCT03538015|"~     Type 1 diabetes mellitus (T1DM) can lead to cardiovascular, renal and neurological~     complications if left poorly-controlled over prolonged periods of time. However, lowering~     glycemic goals for diabetic patients increases their risk for hypoglycemia exposure.~     Hypoglycemia is associated with symptoms such as heart palpitations, fatigue, shakiness,~     anxiety, confusion, and blurred vision. Recurrent hypoglycemia leads to impairment of the~     body's autonomic and symptomatic responses to this condition, and can result in loss of~     awareness in the patient of the hypoglycemic state. Repeated incidences of hypoglycemia from~     loss of this awareness can result in even more hypoglycemic episodes and more severe~     outcomes, such as loss of consciousness, accidents, hospitalization and even death if left~     untreated.~      The aim of this study is to investigate whether adrenergic blockade through the use of~     low-dose carvedilol treatment can improve hypoglycemia awareness and the counterregulatory~     hormone responses to hypoglycemia in T1DM patients with impaired awareness of hypoglycemia.~   "
2203|NCT03538002|"~     The purpose of this study is to investigate if the blue-light filtering spectacle lenses~     promote myopia progression in schoolchildren.~   "
2204|NCT03537989|"~     This is a protocol for a trial carried out from 1999 to 2002. At that time, surgical patients~     received a large volume of intravenous saline during operations on the colon or the rectum,~     often so much fluid that their bodyweight increased by 4-6 kilograms. We hypothesized that a~     restricted fluid regimen could prevent the development of cardiopulmonary complications and~     improve wound healing including the healing of an anastomosis of the gut.~      We designed a clinical randomized assessor blinded multi centre trial comparing a restricted~     fluid regimen to a standard fluid regimen, the difference being the volume of saline~     administered to the patients. Patients undergoing surgery on the colon or the rectum were~     included after informed oral and written consent.~      The restricted regimen aimed at zero-fluid balance with allowance for a body weight increase~     of 1 kg. The standard regimen was a bit dryer than the actual standard; our patients in the~     standard group received saline causing a body weight increase of only 3-4 kg. The fluid~     therapy started at midnight the day of operation, went on through the operation and continued~     on the wards until discharge. The patients were encouraged to eat and drink as much and as~     soon as possible after the operation.~      The primary outcome was the number of patients who died or suffered a complication measured~     within 30 days of surgery. We looked at all complications, but especially heart and lung~     complications and complications related to the healing of wounds and anastomosis.~      The patients was examined in the out patient clinic after 30 days, and in addition blinded~     assessors were reviewing the medical files for registration of postoperative complications.~      The results are published in The Annals of Surgery 2003;238(5)641-48. The restricted regimen~     nearly halved the number of patients with complications, and heart and lung complications~     were allmost eliminated.~      Other investigators confirmed the results, and a more restricted approach to fluid therapy to~     surgical patients has been implemented world wide.~   "
2205|NCT03537976|"~     Using separate prospective cohorts of patients who have lip revision and lip repair surgery,~     the objective of this clinical trial is to both qualitatively and quantitatively assess how~     surgeons integrate the objective measures and visual aids of the Intervention with the~     systematic subjective assessment in order to determine decisions surgery.~   "
4510|NCT03507868|"~     The primer aim of the study was to investigate saliva and gingival crevicular fluid (GCF)~     YKL-40 and also interleukin-6 (IL-6) levels in chronic periodontitis pathogenesis.~   "
2206|NCT03537963|"~     The purpose of this study is to:~      To test a new intervention for sleep disturbance among hematopoietic cell transplant~     survivors. About 50 hematopoietic cell transplant (HCT) survivors will participate in this~     intervention.~      Preliminary Steps: To conduct qualitative interviews with patients, caregivers, and~     clinicians regarding sleep disturbance in hematopoietic cell transplant (HCT) survivors and~     on preferences for a new mHealth intervention for sleep disturbance. About 30 individuals (10~     HCT survivors, 10 caregivers and 5-10 clinicians) will participate in this part of the study.~   "
2207|NCT03537950|"~     This study investigates brain response to single acute dose of cannabidiol, cannabidivarin,~     and placebo in healthy men with and without autism spectrum disorder~   "
2208|NCT03537937|"~     Mechanical ventilation of ICU patients universally involves titration of the fraction of~     inspired oxygen (FiO2) to maintain arterial oxygen saturation (SpO2). Despite decades of ICU~     practice, however, the optimal SpO2 target remains unknown. Current guidelines offer~     divergent recommendations as to the optimal SpO2 target. Therefore, we propose a~     2,250-patient cluster-randomized cluster-crossover trial comparing a lower SpO2 target (90%;~     range 88-92%), an intermediate SpO2 target (94%; range 92-96%), and a higher SpO2 target~     (98%; range 96-100%) with regard to the outcome of days alive and free of invasive mechanical~     ventilation.~   "
2209|NCT03537924|"~     Randomized, placebo controlled trial evaluating efficacy of acetazolamide on right heart~     function during exercise in lowlanders older than 40 years travelling from 760 m to 3'100 m.~   "
2210|NCT03537911|"~     This study evaluates the feasibility and preliminary efficacy of a brief~     cognitive-behavioural program designed to improve cognitive functioning in people with brain~     metastases.~   "
2211|NCT03537898|"~     The administration of intravenous fluids is ubiquitous in the care of the critically ill.~     Commonly available isotonic crystalloid solutions contain a broad spectrum electrolyte~     compositions including a range chloride concentrations. Recent prospective, randomized trials~     have shown improved patient outcomes with the use of balanced crystalloids compared to~     saline. There have not been large randomized studies comparing acetate buffered balanced~     crystalloids to non-acetate buffered balanced crystalloids in the critically ill. BASE will~     be a pilot study for a large, cluster-randomized, multiple-crossover trial enrolling~     critically ill patients from the Medical ICU at Vanderbilt University from June 2018 until~     January 2019. The primary endpoint will be plasma bicarbonate concentration between Intensive~     Care Unit admission and hospital discharge.~   "
2212|NCT03537885|"~     The goal of this study is to monitor the brain using electroencephalography (EEG) while~     transcranial direct current stimulation (tDCS) is being administered, as a potential pathway~     to determine neurophysiological markers capable of forecasting the intensity of a subject's~     response to tDCS.~   "
2213|NCT03537872|"~     The PROvide MIner-friendly SErvices for Integrated TB/HIV Care (PROMISE) study will assess~     the effectiveness, feasibility, and acceptability of integrated tuberculosis (TB)/HIV~     services provided in miner-friendly service venues in Lesotho that address barriers to early~     HIV diagnosis and antiretroviral therapy (ART) initiation, concurrent isoniazid preventive~     therapy (IPT), and retention in HIV care for migrant miners and their families in the context~     of President's Emergency Plan For AIDS Relief (PEPFAR) programming. The study will evaluate~     family-focused, integrated TB/HIV services for Basotho migrant miners and family members~     provided six days per week in miner-friendly service venues (MF), compared to public sector~     health facilities (PS), which will deliver usual integrated care for the management of TB and~     HIV.~      The ultimate goals of the project are to 1) improve health outcomes among migrant miners and~     their families, a hard-to-reach population that represents a hotspot of TB/HIV transmission,~     in Lesotho and in PEPFAR programs more broadly; and 2) strengthen the implementation science~     research capacity of national and local institutions.~   "
2214|NCT03537859|"~     Hospitalization is a stressful event that might impact in a patient's recovery. Children are~     more susceptible to suffer acute stress as a result of a hospital stay. Stress is often~     quantized using cortisol levels, a substance which increases following stressful stimuli.~     Since stress management is important in a patient's recovery, different therapies are used~     and have been evaluated and proven effective to diminish cortisol levels such as play~     interventions and clown therapy. Nevertheless, they rely on volunteers or trained staff to~     perform them. Nowadays, technology such as augmented reality allow us to provide therapy~     without the need of volunteers. This project aims to test if augmented reality technology is~     effective in lowering salivary cortisol levels in hospitalized children.~   "
2215|NCT03537846|"~     Osteoporosis is characterized by low bone mineral density and alterations in bone~     microarchitecture, leading to bone fragility and high risk of fractures. In the~     peri-menopausal period and during menopause, estrogen deficiency is responsible for an~     acceleration of bone remodeling. It is therefore important to sensitize women to this~     pathology at the beginning of menopause.~      Osteoporosis is a public health issue with more than 3 million women in France suffering from~     almost ¼ of the population over 50 years old. Paradoxically, the number of bone densitometry~     and prescribed osteoporosis drugs are decreasing. There is an under-screening and a~     disinterest of the pathology on the part of the medical world and the patients.~      The investigators hypothesize that women lack knowledge about osteoporosis. This study will~     identify these gaps, and put in place appropriate strategies to improve this knowledge.~      For this purpose, a descriptive cross-sectional observational study will carry out, through~     the fulfillment of self-administered questionnaire for women over 30 years old. The main~     objective is to assess the knowledge of women, about osteoporosis and its consequences. The~     judgment criterion is based on a percentage of correct answers per question. The interests of~     the study are to identify gaps in knowledge, to optimize the investigator's therapeutic~     education, to fight patient wait-and-see and false beliefs, and finally to improve adherence~     and longer-term adherence.~   "
2305|NCT03536676|"~     This study will test whether whether the implementation of 'Breakfast in the Classroom'~     improves school breakfast participation and breakfast consumption in middle school~     adolescents; whether the implementation of 'Breakfast in the Classroom' improves appetite~     control, mood, cognitive performance, and unhealthy snacking behavior in middle school~     adolescents; and whether the implementation of a novel 'Higher Protein, 'Egg-cellent'~     Breakfast in the Classroom' leads to additional improvements.~   "
18102|NCT03329989|"~     An open-label study of safety and effectiveness of EN3835 in the treatment of cellulite in~     adult women.~   "
2216|NCT03537833|"~     Pemetrexed is a multi-folate inhibitor approved in the treatment of non-small cell lung~     cancer (NSCLC) and pleural mesothelioma. Its toxicity profile is mainly hematologic (anemia,~     neutropenia and thrombopenia) and can be limiting when > grade 2 according to NCI-CTCAE~     criteria. First clinical trials highlighted hematologic toxicity, especially anemia, which~     was reduced by decreasing pemetrexed dosage from 600 to 500 mg/m² Q3W and by adding~     systematic vitamin supplementation (B9/B12). Despite this, incidence of hematological~     toxicity remains frequent with anemia occurring in more than 20% of patients treated by~     pemetrexed in combination. Methotrexate, a well-known antineoplastic drugs used in several~     cancer and non-cancer disease conditions can also induced severe hematologic toxicity in case~     of methotrexate-reduced elimination and, as a consequence, its accumulation. For example, the~     elimination of methotrexate is mediated by tubular secretion through type 1 and type 3~     organic anion transport (hOAT1 and hOAT3). Association with drugs that inhibits hOATs can~     induced a hematological toxicity caused by methotrexate accumulation. Among these, proton~     pump inhibitors (PPIs) are known to inhibit hOATs. The drug interaction that results from~     their combination with methotrexate is clinically relevant and lead to an increased~     hematological toxicity. However, hypothetical drug interaction between PPIs and pemetrexed is~     unknown while pemetrexed seems to be mostly eliminated by hOAT3 (11-fold higher than~     methotrexate). One study revealed lansoprazole to inhibits in vitro hOAT3. This same study~     investigates in a retrospective chart patients treated by pemetrexed and the study found a~     significant association between combination with PPI and hematological toxicity by~     pemetrexed. Unfortunately this study lacks of relevant methodology and suffered from its~     retrospective chart. This potential drug interaction must be a real concern for oncologists~     and clinical pharmacists. The investigators aim to investigate the potential association~     between PPIs and pemetrexed combination and the incidence of hematological toxicity in a~     multicenter and prospective study.~   "
2217|NCT03537820|"~     World health organization recommends noise level should be less than 30db in hospital.~     However many analysis conclude to an average of 67dB in the post anesthesia care unit. No~     many studies were reported about noise impact in a post-anesthesia care unit. Only one was~     published by B.Allaouchiche in 2002. However, noise is a complaint reported by patients and~     it could be responsible for physiological and psychological troubles. In this prospective~     study, the main objective is to determine patients' satisfaction in the post anesthesia care~     unit, before and after installation of a noise warning device. Between the two parts, a short~     training about noise consequences on health will be presented to nurses. Improvement off~     anti-noise actions on patient's satisfaction will analysed.~   "
2218|NCT03537807|"~     This is an open label expanded access protocol for the treatment of up to approximately 250~     adult patients with amyotrophic lateral sclerosis (ALS) who have difficulty swallowing oral~     riluzole tablets and may be able to derive benefit from treatment with an alternative oral~     formulation of riluzole.~   "
2219|NCT03537794|"~     It is estimated that 30% of individuals with Major Depressive Disorder (MDD) fail to respond~     to conventional antidepressant medication which accounts for over 1 million Canadians in~     their lifetime. Treatment resistant depression (TRD) patients also have greater psychiatric~     and medical comorbidity, poorer quality of life and increased suicidal ideation. Yet, there~     are few treatment strategies available to target TRD and there is a significant lack of~     evidence about how TRD differs from treatment-responsive depression. This proposal represents~     the first study to elucidate the neurobiology of TRD with a focus on dopamine receptor~     function throughout the brain, in order to inform treatment development and clinical~     characterization of TRD.The ultimate goal of this unique study is to characterize striatal~     and extrastriatal dopamine D2 and D3 receptor binding potential in patients with TRD,~     non-resistant MDD and healthy controls. The primary hypothesis is that TRD patients will~     exhibit greater D2/D3 receptor binding potential compared to non-TRD patients in the~     following regions of interest: dorsolateral prefrontal cortex, orbitofrontal cortex, and~     ventral striatum. Secondarily, non-TRD patients will also demonstrate increased binding~     potential compared to healthy controls in the same brain regions. Whole brain analyses will~     allow us to take an exploratory approach to other brain regions that may differentiate TRD~     from non-TRD patients. Participants will be assessed at St. Michael's Hospital (SMH) and the~     Centre for Addiction and Mental Health (CAMH), which are within a 10 minute driving distance~     of each other. There will be 3 study visits following written informed consent. Eligibility~     will be confirmed at a screening visit at SMH where demographic information, including age,~     sex, education, and medication history will be obtained, as well as the administration of a~     structured Mini-International Neuropsychiatric Interview (MINI) for Diagnostic and~     Statistical Manual of Mental Disorders (DSM-5) Axis I diagnoses (Sheehan et al, 2015), and an~     HRSD-17. Within two weeks of the screening visit, participants will undergo a structural~     magnetic resonance imaging (MRI) scan at SMH prior to the positron-emission tomography (PET)~     scan at CAMH. The order of the PHNO scans will be counterbalanced.~   "
2220|NCT03537781|"~     Previous research has shown that nutritional knowledge is a key indicator in healthy eating~     choices, but real-life examinations of the associations between both nutritional knowledge~     and state of hunger and satiety on individuals' food choice of healthy vs unhealthy snacks is~     limited (Drichoutis, Lazaridis, & Nayga, 2005; Grunert, Wills, & Fernandez-Celemin, 2010;~     Nayga, 2000; Petrovici, Fearne, Nayga, & Drolias, 2012; Soederberg Miller & Cassady, 2015;~     Viola, Bianchi, Croce, & Ceretti, 2016).~      The present study aims to investigate whether the presence of nutritional information on food~     labels will affect participants' food choice when hungry and when satiated.~   "
2221|NCT03537768|"~     The proposed research study is a Phase IIb, multi-center, single-blind, randomized study of~     UPA 30 mg, LNG 1.5 mg and LNG 3.0 mg to evaluate EC effectiveness in women with weight ≥ 80~     kg who present within 72 hours of unprotected intercourse.~   "
2222|NCT03537755|"~     The study is being conducted to obtain adolescent girls' thoughts and opinions on~     relationship and communication styles are shown on television.~   "
2223|NCT03537742|"~     The focus of this study is to test the safety and efficacy of the PCSK9 inhibitor, alirocumab~     when administered early after heart transplantation (HT).The main objective of this project~     is to test the safety and impact on cardiac allograft vasculopathy (CAV) of alirocumab when~     given early after HT.~   "
2224|NCT03537729|"~     The ability to find one's way in the world is known as wayfinding. Many older adults who live~     in senior communities, such as independent living and assisted living residences, find~     wayfinding very challenging. Often times, these communities are not designed in a way that~     helps people find their way very easily. When people cannot find their way, they can get~     lost, be dependent upon others for getting out and about, or even be afraid to leave their~     rooms. The purpose of this study is to find out if distinctive signs and decorative elements,~     along with a special type of education called Spaced-Retrieval education, help residents in~     these communities find their way more effectively. Twelve senior communities will be assigned~     by chance to one of three conditions, including: 1) control - no change (the community stays~     the same); 2) signs and decorative elements enhanced; and 3) signs, decorative elements, and~     special education added. After agreeing to be in the study, the participants will be asked to~     find their way to certain places in their community four times over a year. Some people will~     be asked to participate in educational sessions on wayfinding. In addition, some people will~     be asked to wear a location tracker, (like a fitness tracker), for four weeks during the~     year. How well people find their way, along with how much they travel about within the~     communities, will be compared between the three groups. It is hypothesized that those in the~     communities with special signs and decorative elements will find their way more effectively~     than those in the control communities. It is also hypothesized that participants in the~     communities with the special education intervention will find their way better than those~     without the education. Finally, it is hypothesized that participants in the communities with~     signs and cues and education will travel about further distances than those in the control~     communities. The results of the study can help people who have a tendency to get lost find~     their way more effectively in their community, and this could result in more independence.~   "
2306|NCT03536663|"~     EndexoTM is an additive that is blended into the fiber solution during manufacturing of the~     hemodialyzer hollow fibers. The intended purpose of the additive is to increase blood~     compatibility in the finished dialyzer, which is referred to as the dialyzer with Endexo.~   "
3457|NCT03521609|"~     The study aims to evaluate the level of emotional intelligence in patients diagnosed with~     substance use disorder and to evaluate the benefits in emotional skills after a brief~     intervention based on emotional intelligence.~   "
2225|NCT03537716|"~     The study is a prospective multi-center open-label single-arm study. The subjects will be~     enrolled and assigned into a single study group. Subjects will be required to complete four~     (4) treatment visits and four follow-up visits, 1 month, 3, 6 and 12 months after the final~     treatment.~      At the baseline visit photographs of the abdomen will be taken. In addition, adipose/muscle~     layer thickness will be measured with the ultrasound and the subject's weight will be~     recorded. In addition, at the last therapy visit, subjects will receive Subject Satisfaction~     and Therapy Comfort Questionnaires to fill in.~      Safety measures will include documentation of adverse events (AE) including subject's~     experience of pain or discomfort after the procedure. Following each treatment administration~     and at the follow-up visits, subjects will be checked for immediate post-procedure adverse~     event assessment.~      Post-procedure evaluation (follow-up visits) will be conducted 1 month, 3, 6 and 12 months~     after the final treatment. An ultrasound imaging and weight measure will be conducted. Also,~     subject's satisfaction will be noted. During the first (1 month), third (6 months) and last~     (12 months) follow-up visits, photographs of abdomen will be taken.~   "
2226|NCT03537703|"~     Individuals with schizophrenia have difficulties in functioning in the community. No one~     really knows what factors determine how well patients manage in the real world. The purpose~     of this pilot study is to try a new approach to improving a potential determinant of good~     community functioning, namely how we process sounds. Specifically, we propose to examine the~     benefit of combining auditory training exercises with transcranial direct current stimulation~     (tDCS). tDCS is a new tool that is being developed as a safe and noninvasive neurostimulation~     method, for improving processing of sounds. Transcranial direct current stimulation involves~     placing a wet sponge electrode on the head and one on the arm. Electrical current from a~     device powered by a 9-volt battery will flow from one electrode to the other. A small portion~     of the current will pass through the skull and stimulate the brain. This procedure is~     non-invasive and painless and it results in increase or decrease of spontaneous neuronal~     firing in the brain. Neurons are brain cells that send electrochemical messages to each~     other. Its safety and beneficial effect on mental functions has been demonstrated in healthy~     individuals and several clinical populations. The purpose of this study is to determine if~     transcranial direct current stimulation added to auditory training exercises can improve how~     schizophrenia patients process sound.~   "
2227|NCT03537690|"~     This phase I trial studies the side effects and best dose of PEOX-based polymer encapsulated~     paclitaxel FID-007 (FID-007) in treating participants with malignant neoplasms that have~     spread to other places in the body and do not respond to treatment. FID-007 is a packaged~     form of the chemotherapy drug paclitaxel, and uses a polyethylozaxoline (PEOX) polymer which~     may allow the drug to reach deeper into tumors and less into normal cells by being smaller.~   "
2228|NCT03537677|"~     The objective of this pilot study is to quantify patterns of activity and sedentary behavior~     in independent living residents and to collect preliminary data on the feasibility of~     reducing sedentary behavior using a 12-week, behavioral intervention in older adults. We will~     also measure the effects of reducing sedentary behavior on physical function, sleep, quality~     of life, energy/mood, pain and blood pressure. Participants will act as their own controls~     through the use of a double baseline period to examine stability of the physical activity and~     outcome measures.~   "
2229|NCT03537664|"~     This study aim to evaluate an endodontic treatment protocol using adjunctive steps for~     disinfection of teeth with primary endodontic infections.~   "
2230|NCT03537651|"~     This study will evaluate the long-term safety and tolerability of tezacaftor in combination~     with ivacaftor (TEZ/IVA) in subjects with cystic fibrosis (CF) aged 6 years and older,~     homozygous or heterozygous for the F508del mutation.~   "
2231|NCT03537638|"~     Principal objective: To produce scientific knowledge on the effectiveness and~     cost-effectiveness of a multicomponent intervention for knowledge transfer and implementing a~     Clinical Practice Guideline (CPG) for Systemic Lupus Erythematosus (SLE), formed by an~     educative intervention, an computerized clinical decision support system (SADC), complemented~     by an automated feedback built into the electronic clinical record.~      Secondary objectives will be previously developed: 1) the analysis of medical practice~     variations along the care of SLE patients in the Canary Islands Health Service (SCS); 2) the~     best available scientific evidence to support the optimal development of the SADC; 3) the~     context and the barriers to innovation implementation in the SCS; and 4) the development of~     the contents for the implementation strategy, including the SADC and the automated feedback.~      Methods for the main objective: The main objective will be assessed under an open,~     multicentric and randomized (by clusters) clinical trial, in the SCS. The multicomponent~     intervention will be compared to the usual procedures for CPG dissemination. The main measure~     will be the self-perceived activity of SLE rated by the SLAQ scale. Self-perceived health~     related quality of life (HRQoL) data will be obtained by means of the questionnaire EQ-5D-5L~     , to estimate a cost-effectiveness ratio.~      Methods for secondary objectives: The rest of the objectives will be developed by a mix of~     quantitative and qualitative research methods to allow adapting the design, development and~     execution of the intervention to the characteristics of the context.~   "
2232|NCT03537625|"~     The investigators randomly assigned green tea extract, fermented green tea extract, or~     placebo in adult subjects whose BMI was 25-35 kg/m2. Participants were 40 in each group, and~     treatment duration was 12 weeks. Primary outcomes were body weight change and fat mass change~     from baseline to 12 weeks, and secondary outcomes were metabolic parameteres and gut~     microbiota.~   "
2233|NCT03537612|"~     The overall goal of this proposal is to determine if quantitative sensory testing (QST)~     assessing pain modulation can be used as a clinical tool to optimize perioperative pain~     management. The central hypothesis is that the identification of patient's sensory pain~     profile allows personalizing therapeutic approaches to improve individualized pain management~     and thus prevents pain chronicity.~   "
2321|NCT03536468|"~     Tooth loss impact on daily living, mood and self-perceived well-being. However, psychological~     impact of teeth loss has not been evaluated. Present study aims to evaluate the psychological~     conditions of patients pending complete tooth extraction before and shortly after tooth loss~     using Hospital Anxiety and Depression scale (HAD) and Geriatric Oral Health Assessment Index~     (GOHAI).~   "
2322|NCT03536455|"~     Randomized, placebo controlled trial evaluating the effect of acetazolamide on maximal~     exercise performance in lowlanders older than 40 years travelling from 760 m to 3'100 m.~   "
2234|NCT03537599|"~     This phase I/II trial studies the side effects and best dose of donor lymphocyte infusions~     when given together with daratumumab and to see how well they work in treating participants~     with acute myeloid leukemia that has come back after a stem cell transplant. A donor~     lymphocyte infusion is a type of therapy in which lymphocytes (white blood cells) from the~     blood of a donor are given to a participant who has already received a stem cell transplant~     from the same donor. The donor lymphocytes may kill remaining cancer cells. Monoclonal~     antibodies, such as daratumumab, may interfere with the ability of cancer cells to grow and~     spread. Giving daratumumab and donor white blood cells may work better in treating~     participants with acute myeloid leukemia.~   "
2235|NCT03537586|"~     Among patients with stable ischemic heart disease who are referred for coronary angiography,~     a substantial proportion have non-obstructive coronary artery disease (CAD). Ischemia based~     on symptoms or stress testing may be due to coronary microvascular dysfunction in up to 40%~     of these patients. However, the mechanisms and optimal treatment of coronary microvascular~     dysfunction are unknown. Aberrant platelet activity and inflammation have been hypothesized~     as mechanisms of microvascular dysfunction. Investigators plan to evaluate association~     between platelet activity, inflammation, and coronary microvascular dysfunction in stable~     women referred for coronary angiography, and to identify non-invasive correlates of coronary~     microvascular dysfunction in these patients.~   "
2236|NCT03537573|"~     The investigators will assess whether behavioral science-based interventions can nudge~     providers towards more evidence-based care for patients with acute non-cancer pain.~      Aim 1) Among opioid naïve primary care patients with acute non-cancer pain, compare the~     effect of the provider-targeted behavioral interventions (opioid justification and provider~     comparison), individually and in combination, on initial opioid prescription, initial use of~     non-opioid management, and patient-reported pain and function.~      Aim 2) Compare the effect of the 2 provider-targeted behavioral interventions, individually~     and in combination, on unsafe opioid prescribing and transition to chronic opioid therapy.~      Aim 3) Assess provider satisfaction and experience with the provider-targeted behavioral~     interventions.~      Hypotheses:~      Aim 1, H1a: Compared with the guideline (usual care) alone, the addition of the opioid~     justification and provider comparison behavioral interventions will be associated with a~     decreased proportion of opioid prescription and increased proportion of non-opioid management~     at the initial outpatient visit for acute non-cancer pain.~      Aim 1, H1b: Compared with usual care (guideline) alone, the addition of the opioid~     justification and provider comparison behavioral interventions will be associated with no~     difference in patient-reported pain, function, and satisfaction at 1, 6, and 12 months.~      Aim 2, H2: Compared with the usual care (guideline), the addition of opioid justification and~     provider comparison behavioral interventions will be associated with a decreased proportion~     of patients receiving unsafe opioid therapy and a decreased proportion of patients~     transitioning to chronic opioid therapy.~      Study Design: Pragmatic, cluster-randomized clinical trial in 48 primary care clinics.~      Study Population: The patient population will be 10,936 opioid naïve adults who present to~     clinic with acute uncomplicated musculoskeletal pain or headache.~      Primary and Secondary Outcomes: The primary outcome measures will be receipt of an initial~     opioid prescription and unsafe opioid prescribing. Secondary outcomes will be non-opioid pain~     management, and, in 2500 patients, patient-reported pain and function.~      Analytic Plan: The investigators will test for differences in the primary and secondary~     outcomes among the 4 intervention groups.~      Once completed, the project will provide evidence that health systems and other stakeholders~     need to implement interventions to prevent unsafe opioid prescribing.~   "
2237|NCT03537560|"~     1. Detection of IDH2 mutations in AML patients to define it incidence and correlation with~          clinical characteristics, relapse-free and overall survival.~        2. Identify AML patients who are potential candidates for IDH2 inhibitor treatment.~        3. Monitoring minimal residual disease (MRD) following therapy to evaluate its possible~          role in the strategy of MRD-directed therapy in the future in patients carrying IDH2~          mutations at initial diagnosis.~   "
2238|NCT03537547|"~     Major Depressive Disorder is a chronic psychiatric illness that leads to devastating~     consequences at the individual and societal levels. Today, the choice of treatment continues~     to be largely based on subjective factors, primarily the clinician and/or patient's~     preferences, as well as the individual's history of response to treatment, often tainted by~     recall bias. Psychiatric medication decisions are even more arbitrary when the subject in~     question has not had past treatment trials. This often leads to a trial and error process and~     an increasingly resistant disease with each failed trial. Early implementation of an~     objective tool designed for tailoring medication choice to an individual may prove highly~     beneficial in decreasing illness chronicity, individual suffering, and economic burden.~      GeneSight Psychotropic test is a pharmacogenomic decision support tool, developed to help~     clinicians make informed, evidence-based decisions about proper drug selection. Therefore, we~     propose conducting a randomized, double blind, controlled trial to evaluate the impact of the~     GeneSight Psychotropic test to guide treatment decisions in patients with treatment-naïve~     (never having taken medication for depression) Major Depressive Disorder.~      This study will involve 6 visits over about 24 weeks where participants will be randomized to~     have their study clinician have access to their pharmacogenetic report in order to make~     treatment decisions, or to not have access to their report for the first 12 weeks. At Visit~     5, Week 12, all participants will receive a copy of their pharmacogenetics report and all~     clinicians will be unblinded to be able to use the results to guide treatment options for an~     additional 12 weeks.~   "
2239|NCT03537534|"~     Many urological conditions are diagnosed and treated with the use of endourology procedures.~     Unfortunately, dysuria is a common patient complaint following these procedures.~     Intraurethral lidocaine instillation is regularly used prior to office-based endourology~     procedures to alleviate dysuria, as well as, discomfort during the procedure.. Studies have~     confirmed that office-based procedures using intraurethral lidocaine have resulted in less~     patient reported dysuria. Many endourology procedures are done under general anesthesia such~     as urinary stone treatments or resection of bladder tumors. There is a paucity of data~     regarding the use of intraurethral lidocaine at the conclusion of these procedures evaluating~     patient reported dysuria. We have designed a prospective, randomized, placebo controlled~     trial to evaluate the role of intraurethral lidocaine instillation following endourology~     procedures in the anesthetized patient.~   "
2240|NCT03537521|"~     Patients treated with Vitamin K antagonists (VKA) or direct oral anticoagulants as~     Rivaroxaban, Apixaban, Edoxaban or Dabigatran, who experience severe bleeding and/or need~     urgent interventions/operations that cannot wait are included in this registry, or during~     emergency operations~   "
2250|NCT03537391|"~     Prostate cancer (PC) is the most common cancer among men and one quarter of diagnosed PC are~     metastatic at the time of diagnosis. Accurate staging is paramount as the stage is the most~     important factor when treatment decisions are made. The stage is also the single most~     important prognostic factor. Currently, traditional imaging methods for detection of PC~     metastasis, including bone scan (BS) and contrast enhanced whole-body computer tomography~     (CT), are rather inaccurate. Respectively, novel imaging techniques are evolving and novel~     imaging modalities are emerging in PC diagnostics and staging, but their clinical relevance~     is unclear and lacking prospective studies comparing traditional imaging with novel imaging.~      This prospective single-institutional study compares the diagnostic accuracy of novel imaging~     modalities to traditional imaging modalities aiming to find the most appropriate staging~     modality in high-risk PC at the time of initial staging.~   "
18621|NCT03323190|"~     The objective of this study is to determine if inpatient COPD education would result in~     improved patient knowledge of COPD.~   "
2241|NCT03537508|"~     The purpose of this study is to compare the immunogenicity and describe the safety of MenACYW~     conjugate vaccine and MENVEO® when both are administered concomitantly with routine pediatric~     vaccines to healthy infants and toddlers in the US.~      Primary objectives:~        -  To demonstrate the non-inferiority of the immune response after a 4-dose series of~          MenACYW conjugate vaccine compared to a 4-dose series of MENVEO® when given~          concomitantly with routine pediatric vaccines to infants and toddlers 6 weeks to 15~          months of age.~        -  To demonstrate the non-inferiority of the immune response after 3 doses of MenACYW~          conjugate vaccine compared to 3 doses of MENVEO when given concomitantly with routine~          pediatric vaccines to infants at 2, 4, and 6 months of age.~      Secondary objective:~      • To demonstrate the non-inferiority of the immune responses of the routine pediatric~     vaccines administered concomitantly with MenACYW conjugate vaccine as compared with MENVEO to~     infants and toddlers 6 weeks to 18 months of age.~      Observational objective:~      • To describe the safety profile of MenACYW conjugate vaccine and MENVEO when administered~     concomitantly with routine pediatric vaccines in healthy infants and toddlers.~   "
2242|NCT03537495|"~     Tuberculosis meningitis (TBM) is the most severe manifestation of TB, resulting in death or~     neurological disability in up to 50% of affected patients, despite antibacterial treatment.~     This TBM treatment follows the model for pulmonary TB by using the same first-line TB drugs~     (a combination of rifampicin, isoniazid, pyrazinamide and ethambutol) and the same dosing~     guidelines, although it is known that penetration of two of these drugs (rifampicin and~     ethambutol) into cerebrospinal fluid (CSF) is limited. Improvement of treatment of TBM is~     urgently needed.~      To do so, a combination of two interventions will be investigated in this study. A series of~     phase II clinical trials on higher doses of the pivotal TB drug rifampicin in Indonesian~     patients with TBM have shown that the dose of rifampicin can be increased from 10 mg/kg~     orally (standard dose) up to 30 mg/kg orally, resulting in a strong increase in exposure to~     this drug in plasma and CSF, no increase in grade III or IV adverse effects, and a reduction~     in mortality. Similarly, higher doses of rifampicin up to 35 mg/kg resulted in strong~     increases in plasma concentrations; the doses were well tolerated and reduced time to sputum~     conversion in African pulmonary TB patients.~      Next to a higher dose of rifampicin, the approved antibacterial drug linezolid seems a good~     candidate for a new TBM regimen. The drug penetrates well into the CSF and is applied~     successfully against other central nervous system (CNS) infections (e.g. caused by~     penicillin-nonsusceptible Streptococcus pneumoniae, vancomycin-resistant enterococci and~     methicillin-resistant Staphylococcus aureus). In a study in China, linezolid in a dose of 600~     mg BID orally strongly increased recovery of patients with TBM response. Linezolid is also~     being investigated as a new drug for (drug-resistant) pulmonary TB in numerous studies, in a~     dose of 1200 mg once daily. More severe adverse effects to this drug typically occur only~     after prolonged treatment during several months, not during short-term treatment.~      Overall, linezolid is expected to be a promising and tolerable candidate for a new~     intensified TBM treatment regimen consisting of a backbone of high dose rifampicin plus~     linezolid.~   "
2243|NCT03537482|"~     This is a multi-center, single-agent, open-label, Phase I study of APG-2575. The study~     consists of the dose escalation stage and the dose expansion stage.~   "
2244|NCT03537469|"~     Non-depolarizing magnetic fields, like Low Frequency-Pulsed Electromagnetic Fields (LF-PEMFs)~     have shown the ability to modulate living structures, principally by influencing synaptic~     activity and ion channels on cellular membranes. Recently, the CTU Mega 20 device was~     presented as a molecular accelerator, using energy up to 200 Joules and providing high-power~     (2 Tesla) pulsating fields with a water-repulsive (diamagnetic) action and tissue~     biostimulation. The investigators tested the hypothesis that LF-PEMFs could modulate~     long-term corticospinal excitability in healthy brains by applying CTU Mega 20®. Ten healthy~     subjects without known neurological and/or psychiatric diseases entered the study. A~     randomized double-blind sham-controlled crossover design was employed, recording TMS~     parameters (amplitude variation of the motor evoked potential as index of cortical~     excitability perturbations of the motor system) before (pre) and after (post +0, +15, +30~     min) a single CTU Mega 20 session on the corresponding primary right-hand motor area, using a~     real (magnetic field = 2 Tesla; intensity = 90 J; impulse frequency = 7Hz; duration = 15~     minutes) or sham device. A two-way repeated measures ANOVA with TIME (pre, post +0, +15, +30~     min) and TREATMENT (real vs sham stimulation) as within-subjects factor was applied.~   "
2245|NCT03537456|"~     mRDX-02-17 is a device for facial beauty care composed of hyaluronic acid in a concentration~     of 1.5% (p/v), as a functional ingredient, recommended for the correction and treatment of~     wrinkles and dermal depressions.~      The primary hypothesis of this clinical investigation is that, at 30 days after the 60 days~     of treatment with mRDX-02-17, the mean WSRS score assessed by the investigator will decrease~     with at least 0.5 points compared to baseline evaluation.~   "
2246|NCT03537443|"~     Vitamin D deficiency in childhood leads to poor bone growth and muscle weakness, yet it is~     unknown if the amount of vitamin D a woman consumes during her pregnancy affects her child's~     bone and muscle development. In collaboration with researchers in Bangladesh, the~     investigators recently completed a study of vitamin D supplementation during pregnancy in~     which women were assigned to 1 of 5 groups containing vitamin D or placebo (no vitamin D).~     The investigators now aim to conduct a follow-up study of a sample of 250 3-4 year old~     children born to these mothers to test the possible effects of vitamin D supplementation in~     pregnancy on children's bones, their body composition and the strength of their muscles.~   "
2247|NCT03537430|"~     This study is a prospective cohort study.The main study content is the feasibility and~     advantages of tubeless uniportal video-assisted thoracoscopic surgery in total~     thymectomy,divided into exposed and non-exposed groups.Tubeless uniportal video-assisted~     thoracoscopic surgery in total thymectomy in the exposed group, uniportal video-assisted~     thoracoscopic surgery in total thymectomy in the non-exposed group.~   "
2248|NCT03537417|"~     Changes in heart rate variability in anesthetized, ventilated patients undergoing tension~     pneumothorax for thoracoscopic cervical sympathectomy~   "
2249|NCT03537404|"~     The study purpose is to evaluate the potential for a pharmacokinetic drug-drug interaction,~     safety and tolerability when Narlaprevir, Ritonavir (used as a metabolic inhibitor) and~     Tenofovir disoproxil fumarate (part 1) and Narlaprevir, Ritonavir and Raltegravir (part 2)~     are administered in combination to healthy volunteers.~   "
2251|NCT03537378|"~     1.1 Aims：This cohort study aims to investigate the clinical value of Hybrid APC for treatment~     of early central lung cancer.~      1.2 methods：A total of 30 patients with early central lung cancer will be included in this~     open, multicenter, prospective study. Primary observation endpoint is recorded at 3 months~     follow-up, and after 3 months patients could be continued to follow up. The data are~     expressed in terms of mean and percentage. The categorical variables are analyzed by~     chi-square test, and the four table data is analyzed using the exact probability method. The~     continuous variable analysis is used by t test. Statistical analysis is performed with SPSS~     20.0 software. P < 0.05 is considered statistically significant.~   "
2252|NCT03537365|"~     Very preterm infants (<32 weeks gestation) with very low birth weight (VLBW, <1500 g) show~     immaturity of organs and have high nutrient requirements for growth and development. In the~     first weeks, they have difficulties tolerating enteral nutrition (EN) and are often given~     supplemental parenteral nutrition (PN). A fast transition to full EN is important to improve~     gut maturation and reduce the high risk of late-onset sepsis (LOS), related to their immature~     immunity in gut and blood. Conversely, too fast increase of EN predisposes to feeding~     intolerance and necrotizing enterocolitis (NEC). Further, human milk feeding is not~     sufficient to support nutrient requirements for growth of VLBW infants. Thus, it remains a~     difficult task to optimize EN transition, achieve adequate nutrient intake and growth, and~     minimize NEC and LOS in the postnatal period of VLBW infants.~      Mother´s own milk (MM) is considered the best source of EN for VLBW infants and pasteurized~     human donor milk (DM) is the second choice, if MM is absent or not sufficient. The~     recommended protein intake is 4-4.5 g/kg/d for VLBW infants, when the target is a postnatal~     growth similar to intrauterine growth rates. This amount of protein cannot be met by feeding~     only MM or DM. Thus, it is common practice to enrich human milk with human milk fortifiers~     (HMFs, based on ingredients used in infant formulas) to increase growth, bone mineralization~     and neurodevelopment, starting from 7-14 d after birth and 80-160 ml/kg feeding volume per~     day.~      Bovine colostrum (BC) is the first milk from cows after parturition and is rich in protein~     (80-150 g/L) and bioactive components. These components may improve gut maturation, NEC~     protection and nutrient assimilation, even across species. Studies in preterm pigs show that~     feeding BC alone, or DM fortified with BC, improves growth, gut maturation and NEC resistance~     during the first 1-2 weeks, relative to DM, or DM fortified with conventional HMFs.On this~     background, we hypothesize that BC, used as a fortifier for MM or DM, can induce similar~     growth and better NEC and LOS resistance, than conventional fortifiers. A pilot trial is~     required 1) to test the feasibility and initial safety of BC as a fortifier (e.g. similar~     growth rates and clinical variables as conventional fortification), 2) to calculate the~     sample size for a later, larger RCT with NEC+LOS as the primary outcome, and 3) record~     paraclinical outcomes associated with type of fortifier.~   "
2253|NCT03537352|"~     A pilot cross-sectional study will investigate the differential effect of the type of~     disorder (surgical versus non-surgical) on the scores of the 9-item shared decision making~     questionnaire.~   "
2254|NCT03537339|"~     In this study, prospective cohort study was used to collect the general information of~     patients' sex, age, previous history, family history, electrocardiogram, echocardiography,~     cardiac biomarkers TnT, BNP, biochemical examination, and clinical treatment of the patients~     who diagnosed cancer by pathology in National Cancer Center/ Cancer Hospital , Chinese~     Academy of Medical Sciences and Peking Union Medical College from January 2018 to December~     2020. This study intends to evaluate and screen the cardiovascular risk of tumor patients~     during antitumor therapy and to establish a model of cardiovascular risk assessment for tumor~     patients, providing clinical evidence for the prevention of cardiovascular disease risk~     associated with cancer patients.~   "
2255|NCT03537326|"~     This study aims at identifying analisis strategies to detect oral administration of~     Budesonide in women; in order for them to be used by the accredited laboratories of the Worl~     Anti-Doping Agency (WADA).~   "
2256|NCT03537313|"~     Comparison of the effectiveness of povidone-iodine douching and painting for reducing febrile~     morbidity after total abdominal hysterectomy~   "
2257|NCT03537300|"~     Neck pain (NP) is a common work related disorder. Teaching is one profession in which its~     prevalence is high. The Daily job of a school teacher involves head down posture while~     reading, writing, etc., exposing them to risk of developing NP. Deep cervical flexor (DCF)~     muscles have been shown to have lower endurance in patients with cervical impairment which~     has been associated with disability. There is limited evidence that reports efficacy of DCF~     muscles training in occupational NP. This study was done to see the effect of DCF muscles~     training using pressure biofeedback on pain, muscle endurance and functional disability in~     school teachers with NP.~   "
2258|NCT03537287|"~     Preterm birth is a common problem in obstetric care,with estimates ranging from 5% in several~     European countries to 18% in some African countries, Preterm labor defined as delivery before~     37 completed weeks is the leading cause of perinatal and neonatal morbidity and mortality and~     strongly related to the developmental and neurological disabilities later in life..~      There is still considerable uncertainty regarding the optimal progesterone type, route of~     administration, dosage and timing of start of therapy to prevent preterm labor in risky women~   "
2259|NCT03537274|"~     This study will determine the efficacy of PEG-Intron (SCH 54031) in participants with chronic~     Hepatitis C virus (HCV) infection who have not been previously treated with interferon.~     Participants are randomized to receive one of three doses of PEG-Intron (0.5, 1.0, and 1.5~     mg/kg) or Interferon Alfa-2B for 48 weeks. The primary objective of this study is to evaluate~     the efficacy of PEG-Intron (compared to Interferon Alfa-2B) with respect to response based on~     loss of detectable HCV ribonucleic acid (HCV-RNA) and normalization of alanine transaminase~     (ALT) level after 24 weeks of therapy and at 24 weeks of follow-up.~   "
2260|NCT03537261|"~     The purpose of this 24-week study is to determine whether the Parent-based Crisis Prevention~     Institute (CPI) physical management training program (i.e., P-CPI) is effective in~     increasing self-efficacy in parents of children with autism spectrum disorder (ASD).~   "
2261|NCT03537248|"~     The objective of this study is to evaluate the safety and effectiveess of ASP-57~     Multi-Purpose contact lens solution (Test) compared to ReNu® Multiplus Contact Lens Solution~     (Control) when used by habitual contact lens wearers to bilaterally clean and disinfect their~     contact lenses for approximately 3 months (12 weeks).~   "
2262|NCT03537235|"~     Randomized, double-blind, placebo-controlled study aimed at evaluating the effects of a~     3-months treatment with Policaptil Gel Retard on postprandial incretin hormones release and~     satiety in obese women~   "
2263|NCT03537222|"~     In this study, the Myeloma Patient Outcome Scale (MyPOS) will be translated from English to~     German. This translated version will be quantitatively and qualitatively validated with~     patients with multiple myeloma.~   "
2264|NCT03537209|"~     Linear relation between premolars and molars root apex and superior border of inferior~     alveolar canal~   "
2265|NCT03537196|"~     The study aims to assess the effectiveness of a model of hepatitis C screening and integrated~     care, targeting people who inject drugs (PWIDs) in Hai Phong, Vietnam. In a wider~     perspective, this model linked to mass screening through repeated Respondent Driven Sampling~     (RDS) surveys, to simplified treatment protocol, and to large community-based support to~     improve referral to care, retention in care, adherence to treatment and prevention of~     reinfection, may have the potential to eliminate HCV among PWIDs in this city.~   "
2288|NCT03536897|"~     This is a prospective, registry trial which will enroll women aged 65 and above with early~     stage, low risk breast cancer who will be treated with partial mastectomy and intraoperative~     radiation therapy (IORT). The primary aim is to determine the 5-year risk of in-breast tumor~     recurrence. Secondary aims include identification of acute- and late-toxicity, cosmetic~     result, disease-free survival and overall survival.~   "
2266|NCT03537183|"~     Aims and objectives: The primary objective of this study is to assess whether a structured~     exercise program improves cardiac relaxing properties in patients with hypertrophic~     cardiomyopathy (HCM).~      Background: HCM is a hereditary disease in which the myocardium becomes thickened without an~     identifiable cause (other than genetic). It is the most common genetic cardiovascular disease~     with an estimated prevalence of 1/500 (i.e. 10.000 affected individuals in Denmark). The~     majority of patients with HCM suffers from shortness of breath and reduced exercise capacity~     due to increased left ventricular (LV) stiffness. Exercise training has been shown to improve~     exercise capacity and symptoms in patients with HCM, but the mechanisms responsible for this~     improvement are not known.~      Methods and materials: The study is a randomized, single blinded, prospective, controlled~     clinical trial. Eighty patients are recruited from outpatient clinics in the Capital Region~     of Denmark. Patients are randomized in a 1:1 ratio to 12 week of moderate-intensity exercise~     training or usual activity level. Assessments will include right heart catheterization,~     echocardiography, cardiopulmonary exercise testing, blood-samples, quality of life, and, in a~     subgroup of patients, cardiac magnetic resonance imaging. The primary end-point is change in~     LV filling pressure assessed as pulmonary capillary wedge pressure at 25 W workload.~      Expected outcome and perspectives: The investigators hypothesize that an exercise training~     program will reduce cardiac stiffness and improve symptoms in patients with HCM. Training of~     HCM patients has long been debated and the topic is poorly researched. The effects of~     exercise on hemodynamics in HCM patients are unknown and a better understanding of these~     mechanisms is pivotal for improving treatment.~   "
2267|NCT03537170|"~     Severe tuberculosis (TB) leads to wasting and anorexia, increasing risk of the refeeding~     syndrome (RFS) as defined by current criteria. TB patients have high metabolic rates and~     require a high calorie diet, with nutritional supplementation programs improving outcomes.~     BMI inversely correlates with mortality in these patients. Risk of RFS, a life-threatening~     syndrome associated with initiation of feeding after a period of low intake, has not been~     studied in this population and it is not known whether severely malnourished TB patients~     benefit from lower caloric intake. This study aimed to examine the prevalence of RFS in TB~     inpatients in rural India and correlate this with baseline and inpatient caloric intake.~   "
2268|NCT03537157|"~     Crohn's Disease (CD) is a chronic pathology characterized by exacerbations and remissions.~     Recurrent inflammation can cause bowel strictures, fistulae (often perianal) or abscesses. CD~     often requires intestinal resection. Surgery in CD is not curative, Therefore, endoscopic~     follow-up 6-12 months after surgery is recommended. Given the association between enteric~     bacteria and postoperative CD recurrence, antibacterial agents were shown to be effective in~     reducing the severity of endoscopic recurrence, but prolonged administration causes~     significant toxicity. The efficacy of systemic antibiotics and the experimental evidence of~     the central role of luminal flora as an essential factor in the development of post chirurgic~     CD recurrence provide the rationale for evaluating a locally acting antibiotic like~     Rifaximin.~   "
2269|NCT03537144|"~     The purpose of this study is to see if acetaminophen (Tylenol) is as effective as~     indomethacin in closing patent ductus arteriosus in premature infants.~   "
2270|NCT03537131|"~     There are approximately 400,000 people in the UK who are living with type 1 diabetes (T1DM),~     of whom 29,000 are children.~      People with T1DM experience on average 2 episodes of symptomatic hypoglycaemia per week , and~     exercise (especially aerobic) increases this risk . Strategies to prevent hypoglycaemia~     during and after exercise include increasing glucose consumption and reducing insulin dose,~     however overcompensation may result in worsening of blood glucose control.~      Dysregulated glucagon secretion, manifested as a reduced counter-regulatory response during~     hypoglycaemia, is a key feature in T1DM, occurring soon after diagnosis.~      Anecdotal evidence suggests that SGLT-2 (sodium/glucose cotransporter-2) inhibitors (SGLT2i)~     such as dapagliflozin prevent exercise-induced hypoglycaemia in T1DM. SGLT2is promote glucose~     excretion without causing hypoglycaemia.Paradoxically, given their mode of action, they~     increase plasma glucose and stimulate glucagon secretion. Studies in diabetic rats indicate~     that the physiological counter-regulatory response is suppressed in insulin-treated diabetes,~     a defect that can be corrected by somatostatin antagonists.~      The DEPTH trial will test the novel hypothesis that hypoglycaemia results from hypersecretion~     of somatostatin, and that this defect can be corrected by SGLT2i. As these medications are~     already in clinical use, our findings may be rapidly translated into practice. Understanding~     these key processes has the potential to generate novel therapeutic strategies to improve~     glycaemic control, thereby facilitating a more active lifestyle in people with T1DM.~   "
2271|NCT03537118|"~     A randomized, controlled trial to determine whether the use of ultrasound guidance for~     vascular access during coronary angiography or percutaneous coronary intervention (PCI) will~     reduce the rates of major vascular complications.~   "
2272|NCT03537105|"~     By contrast to other proinflammatory cytokines which are found up-regulated in the skin of~     patients with psoriasis, atopic dermatitis or systemic sclerosis, IL-34 is the only cytokine~     that undergoes down-regulation. This finding is interesting regarding the description of~     IL-34 as an immunosuppressive cytokine. In this study, the expression and the role of~     interleukin-34 (IL-34) will be investigated in the physiopathology of systemic sclerosis.~   "
2273|NCT03537092|"~     This is a phase I randomized trial assessing the safety of a single vaginal placebo film~     application. In order to develop a vaginal film which can provide extended release of an~     Antiretroviral (ARV), the film polymers and formulation have been altered from the cellulose~     and polyvinyl alcohol films used to deliver dapivirine and tenofovir in previous trials.~     Therefore, the proposed study will evaluate the safety and persistence of these film polymers~     when applied vaginally.~   "
2274|NCT03537079|"~     Heart failure impairs quality of life and exercise capacity, despite an optimal medical~     therapy. Alternative methods, like hypoxic conditioning coupled to exercise training, must be~     explored and describe~   "
2275|NCT03537066|"~     Continuous positive airway pressure (CPAP) treatment improves sleepiness, depression and~     social activities in patients with obstructive sleep apnea (OSA). This evolution can be~     captured from changes in smartphone usage habits coupled with a mobile-based services. The~     aim of this study is to assess the impact of CPAP treatment on smartphone usage habits in OSA~     patients.~   "
2289|NCT03536884|"~     This is a study to compare the efficacy of bimekizumab versus secukinumab in subjects with~     moderate to severe chronic plaque psoriasis (PSO).~   "
2276|NCT03537053|"~     People with long term conditions such as diabetes and arthritis, and who also have depression~     spend a lot of time sedentary during the day. This is because they face many barriers to~     being active, such as pain and fatigue. Being sedentary is problematic because it is~     associated with poorer health in the long term.~      Common sedentary behaviours are watching television and using the computer; these behaviours~     are labelled as screen-based sedentary behaviours. An intervention to reduce these behaviours~     could improve mental and physical wellbeing. The aim of the study is to explore the~     acceptability of an intervention to Move a Little and Often in people with depression~     symptoms and long term conditions. The investigators will explore the intervention's~     acceptability using interviews and will examine if the intervention is associated with a~     reduction in time spent sedentary. Results will help refine the intervention further.~      The feasibility study is part of a PhD project funded by the National Institute of Health~     Research (NIHR) Collaborations for Leadership in Applied Health Research and Care (CLAHRC)~     Greater Manchester~   "
2277|NCT03537040|"~     The aim of the current study is to pilot a novel intervention to help people explore their~     decision making around the use of neuroleptic medication. A case series design will be used,~     with outcome variables measured at multiple time points pre-, during- and post-intervention.~     Participants will also be asked to complete an evaluation interview post-intervention. The~     primary aim is to investigate the feasibility and acceptability of offering the intervention.~   "
2278|NCT03537027|"~     The purpose of the study is to investigate in vivo whether a high-dose vitamin D3 oral bolus~     (2000 micrograms) produces marked vitamin D receptor target gene expression response and~     whether there is large inter-individual variation. These effects are compared to in vitro~     treatment of peripheral blood mononuclear cells from these subjects with 25(OH)D.~   "
2279|NCT03537014|"~     This multi-site double-blind, placebo-controlled randomized Phase 3 study assesses the~     efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy versus~     psychotherapy with placebo in participants diagnosed with at least severe posttraumatic~     stress disorder (PTSD). The study will be conducted in up to N ≈ 100 participants.~     Participants will be randomized to receive a flexible dose of MDMA or placebo, followed by a~     supplemental half-dose, unless contraindicated, during the Treatment Period with manualized~     psychotherapy in three monthly Experimental Sessions. This ~12-week Treatment Period is~     preceded by three Preparatory Sessions. During the Treatment Period, each Experimental~     Session is followed by three Integrative Sessions of non-drug psychotherapy. The Primary~     Outcome measure is change in Clinician Administered PTSD Scale for DSM 5 (CAPS-5) from~     Baseline. Exploratory measures will address specific symptoms or behavior that is sometimes~     related to PTSD. Drug safety will be assessed by measuring blood pressure, heart rate and~     body temperature during experimental sessions, collecting adverse events and measuring~     suicidal thoughts or behaviors with the Columbia Suicide Severity Rating Scale (CSSRS). This~     study will compare the effects of three manualized Experimental Sessions of psychotherapy~     assisted by flexible doses of MDMA versus placebo. Initial doses per Experimental Session~     include 80 mg or 120 mg of MDMA compounded with mannitol and magnesium stearate or placebo~     alone (mannitol and magnesium stearate), followed 1.5 to 2 hours later by a supplemental~     half-dose (40 or 60 mg). Total amounts of MDMA to be administered per Experimental Session~     range from 80 mg to 180 mg.~   "
2280|NCT03537001|"~     In pre-hospital settings, the administration of analgesics is often delayed because of~     difficult patient access (incarceration), difficulty finding a venous pathway or patient~     refusal.~      An optimization of the management of pain in urgency is therefore still necessary.~      A side from nitrousoxide of which usage remains restrictive, methoxyflurane (Penthrox®) is~     the only volatile analgesic currently available for pre-hospital use.~      The purpose of this study is to answer the question: Does the use of the inhaled route with~     Penthrox add value to the treatment of acute traumatic pain in the pre-hospital stage?~   "
2281|NCT03536988|"~     The objective of this RCT is to compare the postoperative outcome of transanal versus~     transabdominal minimally invasive proctectomy with ileal pouch-annal anastomosis in patients~     with ulcerative colitis.~   "
2282|NCT03536975|"~     Our main goal is to test a web platform accessible by computers, smartphones and tablets,~     addressed specifically to caregivers and people with mild cognitive deterioration or mild to~     moderate dementia providing added value services based on social networks, adapted~     interventions, clinic strategies and gamification to improve the quality of life of~     caregivers and people living with dementia (dyads) and permitting to leave in the community~     as long as possible.~      To evaluate the platform effectiveness and impact in dementia type disease affected people~     and caregivers a randomized, controlled, parallel, longitudinal is proposed. The objective~     will be to assess during 18 months aspects related to health of individuals (general aspect~     of health, neuropsychological, daily living functionalities, quality of life, treatment~     adherence, comorbidities ...), social aspects (improving dyad relationship…) and economics~     (cost-effectiveness of platform utilization), as well as satisfaction degree and usability of~     platform.~   "
2283|NCT03536962|"~     Analyse a multidisciplinary follow-up of amyotrophic lateral sclerosis patients, monitored~     through a Cohort study at Geneva University Hospitals.~   "
2284|NCT03536949|"~     Phase 3 study to evaluate the extended safety of RVL-1201 compared to placebo for treatment~     of blepharoptosis. Eligible subjects will be randomized to one of 2 treatment arms.~   "
2285|NCT03536936|"~     The aim of the study is to retrospectively evaluate brain perfusion and oxygenation in acute~     migraine attacks. Magnetic resonance perfusion and susceptibility weighted imaging are the~     technics to measure perfusion and oxygenation respectively.~   "
2286|NCT03536923|"~     This open-label proof-of-concept study is designed to evaluate the impact of the leva digital~     incontinence system on the treatment of stress and mixed urinary incontinence in women over a~     six week period. Subjects will participate in a 2.5 minute exercise program twice daily~     (performed at a clinic with therapist assistance 5x weekly, and at home once daily on~     weekdays and twice daily on weekends. Validated surveys (UDI-6, IIQ-7 and PGI-I) will be used~     to evaluate symptom relief. A battery of pelvic floor muscle exercises will be performed~     weekly to evaluate progress in muscle strengthening.~   "
2287|NCT03536910|"~     In this study, investigators aimed to investigate the effects of general and spinal~     anesthesia techniques on copeptin levels during cesarean section and their relation with~     fetal distress.~   "
2290|NCT03536871|"~     To understand the effects of a novel dietary supplement when used in conjunction with a~     healthy lifestyle exercise program and to define biomarkers that are specific to sarcopenia.~     A primary aim in the present study is to determine whether a relationship exists between~     positive changes in body composition through increases in lean mass and reductions in body~     fat following oral supplementation of naturally occurring food components in combination with~     exercise. The purpose of the present study is to examine the effects of a multi-nutrient~     supplement in combination with a combined endurance and resistance based exercise~     intervention in a cohort of young sedentary men and women (consequently, most will be~     overweight or obese) and a cohort of older adult men with varying degrees of sarcopenia~     (McMaster/CIHR/Exerkine project). A sub-purpose nested within the study is to provide serum~     and muscle samples for use in an aging/sarcopenia biomarker discovery study taken at~     pre-intervention for the young and older men (Buck Institute/Astellas project).~   "
2291|NCT03536858|"~     There are significant and persistent disparities in access to kidney transplantation and as a~     result most patients with end stage renal disease receive hemodialysis (HD). HD is unique as~     it is a treatment performed in a group setting which lends itself to forming social networks.~     The goal of this research study is to identify and characterize the social networks of HD~     patients and measure the influence of HD social networks on knowledge, attitudes, and~     behaviors towards transplantation using repeated surveys and a network targeted educational~     intervention.~   "
2292|NCT03536845|"~     To determine the maintenance dose of vitamin D supplementation required for children with~     epilepsy to maintain normal vitamin D level.~   "
2293|NCT03536832|"~     Subcuticular skin closure with suture after cesarean has been shown to result in lower rates~     of wound complications than with staple closure. However, the optimal choice of suture~     material for subcuticular skin closure is unclear. Vicryl vs Prolen suture materials will be~     used for subcuticular closure of transverse skin incisions after cesarean section. Patiients~     will be controlled for superficial surgical site infections 1 week after the cesarean~     section.~   "
2294|NCT03536819|"~     Evaluation of efficacy and safety of the Votiva RF system with the Forma V handpiece for~     vaginal treatments.~   "
2295|NCT03536806|"~     The purpose of this randomized, double blind, placebo-controlled, superiority clinical trial~     was to assess clinical efficacy of potassium canrenoate - canrenone in rapid conversion of~     atrial fibrillation to sinus rhythm.~   "
2296|NCT03536793|"~     This study will measure the levels of uTF and Endo180 in patients with pancreatic cancer, and~     also in patients with pancreatic cysts in which cancer may be suspected, to determine the~     accuracy of these tests in detecting early stage pancreatic cancer. The effective diagnosis~     of pancreatic cancer is often quite challenging, due to a lack of disease-specific symptoms,~     resulting in the majority of patients presenting with advanced disease, with an associated~     dismal prognosis. Earlier detection of pancreatic cancer, at a stage where surgery is~     feasible, would greatly increase the 5-year survival rate. Detecting pancreatic cancer early~     is therefore vital to improve the prognosis for these patients.~      Precancerous pancreatic cysts are an early indicator of malignant transformation. The ideal~     screening test would be capable of detecting pancreatic cancer at these initial stages.~     Current procedures for pancreatic cancer diagnosis are invasive, uncomfortable and costly,~     and can be considered unnecessary in those cysts found to be benign.~      The investigators propose two potential markers of early pancreatic cancer: urinary tissue~     factor (uTF) and Endo180. ELISA tests have been developed to measure the levels of TF in~     urinary microvesicles and Endo180 concentration in urine, serum and cystic fluid samples.~   "
2297|NCT03536780|"~     A Phase 2 trial of avelumab plus gemcitabine in advanced leiomyosarcoma as a second line~     treatment~   "
2298|NCT03536767|"~     This prospective, multicenter open-label study will evaluate the long-term safety,~     tolerability, PK and PD of AG10 administered on a background of stable heart failure therapy.~   "
2299|NCT03536754|"~     A Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate~     the Safety and Efficacy of CCX140-B in Subjects with FSGS to be conducted in the North~     America, Europe and Australia~   "
2300|NCT03536741|"~     The present study aims to demonstrate the effectiveness of loco-regional wall anesthesia of~     the transversus abdominis plane block (TAP block) and the rectus sheath block (RS block),~     compared to intravenous analgesia, in terms of pain reduction, postoperative analgesic drugs~     consumption, patient satisfaction and decrease of LOS (length of stay), in patients~     undergoing benign gynecological laparoscopic surgical procedures.~   "
2301|NCT03536728|"~     A Phase 1 study will be conducted to establish safety and dose level of AMXT 1501 dicaprate~     alone, and in combination with DFMO, in cancer patients.~   "
2302|NCT03536715|"~     The purpose of this study is to conduct concept elicitation and cognitive debriefing~     interviews with patients who have been implanted with the KAMRA inlay in order to assess the~     content validity of a PRO instrument~   "
2303|NCT03536702|"~     The primary purpose of this study is to determine whether creative writing in newly diagnosed~     cancer patients and those with recent progression in their disease will have a positive~     impact on their mental health. Using a randomized controlled trial approach, emotion~     thermometers will be employed to evaluate participants' responses on a number of domains,~     such as anxiety, depression, despair, and anger along with a series of survey questions to~     monitor changes in depressive and anxiety symptoms. Open-ended survey questions will be used~     to capture how a creative writing intervention impacts participants' experience of their~     illness. Melissa Greene's Write from the Heart program focuses more on creative writing~     rather than cancer focused topics. Patients in the intervention arm will complete -one and a~     half hour group sessions every two weeks over the span of 3 months. Participants in the~     active control arm will be provided a book (i.e., Writing Down Bones by Natalie Goldberg)~     about creative writing and will be asked to do activities for 1.5 hrs every 2 weeks for a~     period of 3 months.~   "
2304|NCT03536689|"~     Comparison of amniotic fluid index between before and after maternal position change in~     Upright and left lateral decubitus maternal position~   "
2342|NCT03536195|"~     Renal failure and high plasmatic level of urea have been associated with an increased risk of~     hemorrhage in surgical patients. There is only sparse data on the impact of renal replacement~     therapy on homeostatic parameters. The aim of this study is to describe potential changes in~     homeostatic parameters before and after renal replacement therapy.~   "
2307|NCT03536650|"~     Non-alcoholic fatty liver disease (NAFLD) is a frequent disease affecting up to 25% of the~     USA population, 2-44% in Europe and up to 42,6-69,5% in patients with type 2 diabetes. It is~     a disease that could progress from simple steatosis to non-alcoholic steatohepatitis (NASH),~     hepatic cirrhosis and hepatocarcinoma. NASH is part of continuum of metabolic syndrome and~     constitutes a serious public health concern manifesting by premature cardiovascular disease,~     end stage diabetes complication and will likely become the first cause of end stage liver~     disease. Insuline resistance is the hallmark of NASH. Some recent studies both in animals and~     humans have demonstrated abnormal hypertrophy of the duodenal mucosa, changes in~     enteroendocrine cell density and number, endocrine hyperplasia, and alterations in gut~     hormone signaling highlighting the role of the upper intestine gut in glucose homeostasis and~     thus insulin sensitizing. Given these physiological and pathophysiological features, abrasion~     of duodenal mucosa was assessed both in animals and humans. The investigators reported an~     improvement in both glucose homeostasis and transaminases levels suggesting possibly an~     improvement of NASH. Until now, lifestyle medication is the only recognized efficient~     treatment for fatty liver disease. Unfortunately, only a minority of patients achieve a~     significant weight loss and lifestyle modifications. The investigators aim to study the~     duodenal mucosal resurfacing procedure in patients with NASH biopsy proven in a proof of~     concept study allowing to assess this technique as a potential treatment to NASH.~   "
2308|NCT03536637|"~     The objective is to evaluate the tolerability, safety, and efficacy of DMT310 topical powder~     mixed with diluent in male and female patients with moderate to severe facial acne vulgaris.~   "
2309|NCT03536624|"~     Work-related stress is a public health issue. Among the multiple physical and psychological~     consequences of stress, increased mortality and cardiovascular morbidity seem the main~     concern. The thermal spa resort of Néris-Les-Bains is one of the five spa resorts in France~     specialized in the treatment of psychosomatic disorders. Among all these resorts proposing a~     thermal residential program of three weeks, only one thermal spa resort (Saujon) has a~     program for occupational burn-out. However, a shorter thermal spa residential program seems~     more compatible with professional context (availability of individuals), and focusing on~     work-related stress prevention (before the state of burn-out).~      The main hypothesis is that a short thermal spa residential program (6 days) of work-related~     stress prevention will exhibit its efficacy through objective measures of well-being and~     cardiovascular morbidity.~   "
2310|NCT03536611|"~     This study is to compare the efficacy and safety of dabigatran ethidium b.i.d.+ clopidogrel +~     ASA [100 mg q.d. *1 month] and warfarin + clopidogrel + ASA [100 mg, q.d.*1 month] in Chinese~     NVAF patients undergoing PCI with stenting (elective or due to ACS).~   "
2311|NCT03536598|"~     To evaluate the safety and efficacy of CJ-30060 compared with amlodipine/valsartan~     combination therapy and valsartan/rosuvastatin combination therapy in hypertensive patients~     with hyperlipidemia~   "
2312|NCT03536585|"~     The study evaluates the use of multi-polar radiofrequency (RF) and pulsed electro-magnetic~     fields (PEMF) energies for the treatment of vaginal looseness and for the treatment of the~     mons pubis and labia for skin tightening. All subjects will receive a total of three internal~     and three external treatments at four week intervals. Subjects will be followed up at one and~     four months after treatment is complete.~   "
2313|NCT03536572|"~     Obstructive sleep apnea (OSA) is a major chronic condition affecting the quality of life of~     millions of Americans. Per the Institute of Medicine new treatment adherence strategies are~     needed to help improve the quality of care, reduce social and economic costs, and help those~     with chronic conditions, including OSA, live healthier and more productive lives through~     better management of their conditions. Adherence with continuous positive airway pressure~     (PAP) therapy is disappointingly low, and new methods to increase both the use and efficacy~     of therapy are needed. Historically, patients have not been formally instructed to adjust~     their pressure settings on their PAP devices; practically, however, allowing patients to~     adjust their pressure settings fosters engagement, self-confidence, and control with therapy.~   "
2314|NCT03536559|"~     The objective of this trial is to assess the efficacy and safety of CNM-Au8 as a~     remyelinating treatment for vision-impairing MS lesions in participants who have chronic~     vision impairment as a result of Relapsing Remitting Multiple Sclerosis. The primary endpoint~     is the improvement in remyelination as measured by visual evoked potentials after 24 weeks of~     treatment. The secondary endpoint is the improvement in low contrast vision as measured by~     low contrast letter acuity after 24 weeks of treatment.~   "
2315|NCT03536546|"~     The investigators will conduct a study to examine the impact of an alcohol peer-mentor~     intervention starting in the emergency department (ED) combined with 6 peer booster sessions~     to reduce hazardous drinking and facilitate primary/specialty care use compared to enhanced~     usual care. Approximately 450 Veterans with hazardous drinking behaviors will be randomized~     to one of these two conditions. Follow-up assessments will occur at 3-, 6-, and 12-month~     post-randomization.~   "
2316|NCT03536533|"~     The aim is to assess the effects of virtual reality-based intervention on vestibular~     functions in in patients with chronic peripheral unilateral vestibular hypofunction.~   "
2317|NCT03536520|"~     Randomized, placebo controlled trial evaluating the effect of acetazolamide on visuo-motor~     learning performance in lowlanders older than 40 years travelling from 760 m to 3'100 m.~   "
2318|NCT03536507|"~     Randomized, placebo controlled trial evaluating the effect of acetazolamide on sleep~     disordered breathing in lowlanders older than 40 years travelling from 760 m to 3'100 m.~   "
2319|NCT03536494|"~     This study was a multicentre, quasi-experimental design, controlled, before-and-after trial~     to estimate the effectiveness related to the review of mirabegron use and its deprescribing.~      Intervention group: Patients with mirabegron prescription assigned to any of the 17 primary~     health care centers located in the northern area of Barcelona.~      Control group: All the other patients assigned to any of the other 34 health care centers in~     Barcelona belong to Catalan Institut of Health (CIH).~      The structured intervention included initiatives with general practitioners and~     urology/gynaecology specialists, support from health care authorities, and monthly feed-back~     monitoring to general practitioners.~      The follow-up period was 12 months, from January 1st to December 31st, 2017.~   "
2320|NCT03536481|"~     The main objective of this study is to evaluate the bioequivalency of two preparations of~     ensartinib capsules in Chinese healthy volunteers.~   "
2323|NCT03536442|"~     Intimate partner violence (IPV) is a significant and pervasive public health challenge and is~     associated with mental illnesses such as depression, anxiety and posttraumatic stress~     disorder (PTSD). Although the perinatal period may be a time of greater risk for experiencing~     IPV, and greater vulnerability to PTSD symptomatology, a lack of research exists pertaining~     to the identification/treatment of IPV-related PTSD symptoms during this period. Utilizing a~     mixed-methods approach, and employing a feminist, intersectional framework, the effectiveness~     of trauma-informed cognitive behavioural therapy (CBT) among pregnant survivors of IPV~     experiencing PTSD symptomatology on depression, anxiety, PTSD and maternal-infant attachment~     will be explored.~   "
2324|NCT03536429|"~     Randomized, placebo controlled trial evaluating the effect of acetazolamide on postural~     control in lowlanders older than 40 years travelling from 760 m to 3'100 m.~   "
2325|NCT03536416|"~     Approximately 1.1 million children and young people in the United Kingdom (UK) are living~     with asthma, making it the most common chronic disease in children in the UK. Our recent~     observational study found that poor asthma control, poor medication adherence, and a poor~     understanding of asthma were key unmet needs of secondary school children. Following the~     findings from our earlier study, we have developed a preliminary theory-based multi-faceted~     intervention, aimed at improving asthma self-management and control in young people.~   "
2326|NCT03536403|"~     Spinal diseases often induce gait disorders with multifactorial origins such as lumbar pain,~     radicular pain, neurologic complications, or spinal deformities. However, radiography does~     not permit an analysis of spinal dynamics; therefore, sagittal balance dynamics during gait~     remain largely unexplored. This prospective and controlled study try to assess the Vicon~     system for detecting sagittal spinopelvic imbalance and to determine the modification induced~     by ant induced anterior sagittal imbalance on the kinetics walking parameters~   "
2327|NCT03536390|"~     This 6-week study is to determine if the study drug, Methylphenidate Hydrochloride (HCl)~     Extended-Release Chewable Tablets (ERCT), is safe, tolerable and effective when compared to a~     sugar pill or placebo in children 4 to 5 years of age with ADHD.~   "
2328|NCT03536377|"~     The complications associated with uncontrolled type-2 diabetes mellitus (T2DM) are numerous;~     reducing the quality of life for the patient and consuming a considerable portion of~     healthcare finances.~      The Health of the Nation (HotN) 2011 study reported that 50% of the Barbadian population~     >65years old had a diagnosis of T2DM and that two-thirds of the population were overweight -~     which is a risk factor for the development of T2DM.~      Encouraged by the success of the Counterpoint study in the United Kingdom (UK), the Barbados~     Diabetes Reversal Study 1 (BDRS1) was established using a similar protocol; the aim of which~     was to evaluate the feasibility of implementing a very low calorie diet to reverse T2DM in~     Barbados. At the end of the 8-week intervention period, the 25 participants had achieved an~     average weight loss of 10.1kg (22lbs). This was accompanied by an increase in the number of~     participants whose fasting blood sugars were now within normal range despite being off of~     their diabetes medication; and a decrease in the number of participants taking blood pressure~     medication. Participants transitioned to a solid diet over a 4-week period, with guidance on~     health dietary habits and regular exercise routines. The benefits accrued during the~     intervention phase were preserved at the end of the transition period.~      We now propose the Barbados Diabetes Remission Study 2 (BDRS2) as a sustainable community~     intervention - utilizing the local church as the community site. We hypothesize that this~     will enhance reach while reducing the cost of the study and will also facilitate the~     structures necessary for the social support of the participant.~   "
2329|NCT03536364|"~     The natural history of type 2 diabetes commonly follows a pattern of postprandial~     dysregulation followed by fasting hyperglycemia leading to overt type 2 diabetes.~     Approximately 38% of the US adult population is estimated to have pre-diabetes. In a previous~     study of 16 overweight/obese patients with metformin treated type 2 diabetes, using a typical~     Western meal, investigators demonstrated that a food order in which protein and vegetables~     are consumed first, before carbohydrate, results in significant lowering of incremental~     glucose peaks compared to the reverse order. In the present study, investigators seek to~     expand on the previous findings to gain further insight into the impact of food order in~     individuals with pre-diabetes, using a meal with different macronutrient composition, in the~     setting of three meal patterns. The study is designed to be a simple, practical intervention~     that may have very significant clinical implications for prevention of diabetes in a large~     population at increased metabolic risk.~   "
2330|NCT03536351|"~     This is a one group pre-post feasibility study of an interdisciplinary (theatre, Occupational~     Therapy (OT) and Speech Language Pathology (SLP)) intervention targeted at social skill~     development in children, aged 3-4. The intervention uses process drama modified with OT and~     SLP techniques and using typically developing peer models . Feasibility outcomes are~     recruitment rates, retention rates, daily program records of ease of implementing the~     program, and record of modifications needed. Child primary outcomes are Social Skills~     Improvement Scale (SSIS) and the Theory of Mind (ToM) Battery and Inventory within 4 weeks of~     program end. Secondary outcomes will be the Structured Play Assessment (SPA) within 4 weeks~     post-intervention, observations of social interactions (e.g.,eye contract, joint attention,~     verbal utterances, physical contact) during intervention sessions, brain activity in frontal~     and temporal/parietal areas during ToM tasks measured by high density EEG within 4 weeks of~     program end, and parental interview at 3 months related to child's social skills.~   "
2339|NCT03536234|"~     An open, randomised, parallel arm phase IIa study. 52 HIV-1 infected patients will be~     randomised (in a 1:1 ratio) to either an active group or a control group. The active group~     will receive the GnRH analogue triptorelin depot monthly at baseline, week 4 and week 8.~     Patients in the active group and in the control group will continue their triple combination~     antiretroviral therapy (ART) during the study without changes; unless there is rationale for~     change on medical ground. In order to prevent the negative effects of a low testosterone~     level, patients in the active group will be offered to receive a single intramuscular depot~     injection of testosterone approximately 7 days after triptorelin treatment. This depot~     administration will keep the serum testosterone on a normal level until the next triptorelin~     dose. This will be repeated when triptorelin is administered at week 4 and week 8. Total~     study period is 24 weeks.~   "
2340|NCT03536221|"~     To determine the prevalence of pelvic organ prolapse and urinary incontinence among women in~     Minnesota using a short web-based self-administered questionnaire.~   "
2331|NCT03536338|"~     An injury to the spinal cord can be life altering: with a 'complete' injury, the affected~     individual is unable to move their legs at all and may become wheelchair-bound. While a~     'complete' injury suggests that the cord was completely severed, it is actually more common~     for some connections in the spinal cord to remain after it is injured but, for some reason,~     they are inactive or sleeping.~      Electrical stimulation applied to the skin surface at the lower back appears to 'wake up'~     these remaining connections, allowing some (previously unavailable) leg movements. The first~     time they had this spinal stimulation (SS), people with long-standing 'complete' spinal cord~     injuries became able to move their legs and, after several weeks of SS, these movements~     seemed to increase. They also noticed other changes taking place, including improvements in~     their bladder control.~      SS has been shown to cause strong leg extension movements, and one person with SCI stood up~     with SS, using minimal support. SS for standing may assist people with SCI to carry out daily~     tasks at home, which would hugely benefit the SCI community.~      In this study we will explore whether SS enables people with SCI to stand up and whether~     regular sit-to-stand training combined with SS improves; i) standing ability; ii) bladder~     control and; iii) well-being, in people with SCI.~      Ten volunteers with SCI will carry out an 8-week sit-to-stand training programme. Training~     will be carried out 3 times/week at Neurokinex using their Keiser Power Rack. The volunteers~     will be randomly assigned either to the control (sit-to-stand only) or test (sit-to-stand~     plus SS) group. Measurements will be taken before and after the training programme to assess~     standing ability, bladder function, and well-being.~   "
2332|NCT03536325|"~     The purpose of this study is to assess the safety and tolerability of guselkumab following~     single-dose intravenous (IV) infusion in Japanese healthy male participants.~   "
2333|NCT03536312|"~     The ascending aorta conducts blood from the heart to the rest of the body. The ascending~     aorta can become enlarged, and the risk of tearing and rupturing becomes higher with larger~     aorta. When the ascending aorta tears or ruptures, the risk dying is high even if surgery is~     done as soon as possible. Traditionally, when the ascending aorta gets above 5.5 cm, surgery~     is recommended to replace the aorta. However, this threshold is based relatively weak~     evidence, and sometimes patients with smaller aorta can tear or rupture. On the other hand,~     surgery carries its own risk as well. Since there are risk of waiting or doing surgery, there~     is currently no great support for either approach for patients with a smaller aorta. In the~     TITAN SvS trial, patients with an ascending aorta between 5.0 to 5.5 cm is assigned by chance~     to the early surgery group, in which they will undergo replacement of aorta, or the~     surveillance group, in which they will be closely monitored. The chance of dying or suffer~     tearing or rupture of aorta between the two groups will be compared. The result of the trial~     will guide future practice for patients with enlarged ascending aorta.~      This is a prospective, multi-centre randomized control trial that compares the all-cause~     mortality, aneurysm-related aortic events, rate of stroke, and quality of life for those~     patients undergoing early elective ascending aortic surgery to those patients undergoing~     surveillance. Patients referred for an ascending aortic aneurysm that meets the inclusion~     criteria will be randomized to the early elective surgery group or the surveillance group.~     Recruitment will end when the desired sample size is reached, and the patients will be~     followed for a minimum 2-year period. The primary objective of the trial is to compare the~     composite outcome of the all-cause mortality and incidence of acute aortic events between~     surveillance and elective ascending aortic surgery for patients with degenerative or bicuspid~     valve-related ascending aortic aneurysm after 2 years of follow up. The hypothesis is that~     the early surgery group will have a significantly lower all-cause mortality and incidence of~     acute aortic events at 2 years of follow up compare to the surveillance group. The result of~     this trial will provide evidence based guidance in the appropriate management of ascending~     aortic aneurysm based on the size criteria, and establish a large database for future~     investigations.~   "
2334|NCT03536299|"~     The purpose of this study is to determine the utility of a performance measure for the~     dual-task of gait and considering people with multiple sclerosis have both cognitive and~     motor problems, the secondary aim of this study is to determine the effectiveness of a~     gait-specific dual-tasking intervention for ambulatory individuals with multiple sclerosis.~   "
2335|NCT03536286|"~     The South Kivu province of DRC has experience continuous armed conflict over the last several~     decades; as a result, livelihoods and health metrics are uniformly poor. Thus, the objective~     of this study is to determine if an integrated set of social enterprises can improve child~     health while offering viable and scalable new business opportunities for the community.~     Specific research questions include the impact of the individual enterprises on (1) child~     health, (2) access to clean water, and (3) economic opportunities in the region.~   "
2336|NCT03536273|"~     INTRODUCTION AND AIM: The Pilates exercises were introduced by Joseph Pilates in the 1920s,~     originally called 'centering'. These exercises work on 6 simple principles with or without~     special equipment. These principles are; centering, concentration, tenderness, flow and~     respiration. (Yamato et al., 2016) Functional movement analysis is a screening system~     developed by physiotherapist Gray Cook. Functional deficits of the person are detected by 7~     different movements (Cook, Burton and Hoogenboom 2006a, Cook, Burton and Hoogenboom 2006b).~     In a single study they compared in the literature that assessed the effect of Pilates~     exercises on functional movement, this activity was explored on recreational runners (Laws,~     Williams and Wilson 2017). The aim of this study was to investigate the effect of 12-week~     pilates group exercise training on functional movement scores in sedentary women.~     Secondarily; posture, depression level and quality of life will be evaluated.~      MATERIAL-METHODS: This study has been reviewed by Ethics Committee of Non-Interventional~     Researches of the University of Medipol in Istanbul and its ethical conformity has been~     approved. (10840098-604.01.01-E.45484). Participants were informed of the voluntary consent~     form and signed the consent form.~      Participants 20 sedentary women were included in the study between 30-50 years of age.~      Evaluations~      Demographic information (Age, Occupation, Height, Weight) of the persons will be~     recorded.Functional Movement Analysis; Postural Analysis, Depression level; Health Related~     Life quality will be recorded.~      Application Pilates exercises will be applied by a qualified physiotherapist with an~     internationally recognized certificate on the subject. Participants will be asked to come up~     with suitable outfits. the exercise room will be set at the ideal temperature and well~     ventilated. The exercises to be done in the form of group exercises will be started with an~     entry level, and the level of the exercises will be increased appropriately in the following~     weeks. Each group will consist of no more than 10 people and the exercises will continue for~     three sessions per week for 12 weeks. The evaluations will be repeated before exercise, at~     the end of 12 weeks of exercise and after 3 months from finish of the exercise period.~   "
2337|NCT03536260|"~     Immediate implant placement has a success rate from 94-100 % . After tooth extraction there~     is a loss in the horizontal and vertical dimension by about 3-6 mm and 1-2 mm respectively~     and alveolar crest resorption of about 44% especially through 6 months after extraction.~      After immediate implant placement there is usually a void between the implant and the socket~     walls which is called jumping distance or gap which may heal spontaneously or need bone graft~     to bridge the space. If the gap is 1-2 mm it may heal spontaneously more than that this will~     need bone graft. There is no evidence that the graft impairs osseointegration Development of~     artificial bone has increasingly progressed in the last few years. Nanobone nanocrystalline~     hydroxyapatite embedded in a porous silica gel matrix bone graft is introduced which has~     osseoconductive and biomimetic properties .the sub-micron modification in the bone substitute~     will enhance osteogenic property. It bind to the bone by stimulation of osteoblast activity~     and enhance growth factors which improve bone healing and provide more strength and stability~     to the implant.~   "
2338|NCT03536247|"~     Our aim is to compare the efficacy, safety, procedural time required, and costs of a strategy~     initially employing cholangioscopy guided laser lithotripsy versus a strategy initially using~     papillary dilation for removal of large bile duct stones.~   "
2344|NCT03536156|"~     In the case of unitary edentulousness, a dental implant is a prosthetic device fixed in the~     bone which makes it possible to receive a fixed dental prosthesis (crown). Peri-implant soft~     tissues (gums) play an essential role in the integration of the crown. Indeed, the implant~     gingival emergence profile provides an aesthetic integration mimicking that of a natural~     tooth. This implant emergence profile (EIP) is modeled during the surgical and / or~     prosthetic phases.~      The problem comes from the labile character of the EIP (Emergence Implant Profile). If the~     literature evokes this problem, the instability of the volume of the EIP during the~     impression phases has never been measured. Moreover, the three-dimensional behavior of the~     EIP over time (kinetic) during the acquisition phases is not known.~      Objective study of the mobility of gingival tissues of the implant emergence profile (IEP),~     using an intra-oral optical camera, would scientifically measure the labile aspect of the IEP~     and improve the procedure of registration of peri-implant soft tissues~   "
2345|NCT03536143|"~     This study is being conducted to determine if topical KB103 (HSV1-COL7) can safely and~     effectively restore functional collagen VII expression in DEB patient skin (primary endpoint)~     and promote healing of DEB patient wounds (secondary endpoint).~   "
2346|NCT03536130|"~     This study is designed to compare the electronic chest drainage system (Drentech Palm Evo)~     with the traditional system, both already in use in the clinical practice, in a cohort of~     patients who received thoracoscopic lobectomy. This study is not evaluating safety or~     efficacy of these systems.~      This study's primary aim is to determine if the use of a digital chest system compared with a~     traditional system reduce the duration of chest drainage and length of hospital stay.~     Moreover, the investigators aim to quantify the variability of results regarding the~     subjective observer evaluation of active air leaks (through the traditional system) compared~     with the objective data registered by the digital system.~      Finally the investigators want to evaluate whether it is possible through the digital device~     to distinguish an active air leak from a pleural space effect by the evaluation of~     intrapleural differential pressure and to identify potential predictors of prolonged air~     leaks.~   "
2347|NCT03536117|"~     A new effective tuberculosis (TB) vaccine is essential to achieve World Health Organization~     (WHO) End TB goals and eliminate TB by 2050. The optimal long-term strategy would be a~     combination of serial mass campaigns in adults, coupled with universal newborn vaccination.~     Newborns are the only human population without prior mycobacterial exposure in TB endemic~     countries and as such, live attenuated mycobacterial vaccines may offer better protection to~     this naïve population compared to adults.~      MTBVAC is a novel TB vaccine candidate generated by genetically attenuating an M.~     tuberculosis clinical isolate of the EuroAmerican lineage. MTBVAC is based on two~     independent, stable genetic deletions of the genes coding for two major virulence factors,~     phoP coding for the transcription factor PhoP and fadD26 coding for the synthesis of PDIM.~     Since MTBVAC contains most of the genes deleted from BCG, it presents a wider collection of~     mycobacterial antigens to the host immune system. Safety and immunogenicity of MTBVAC has~     been demonstrated in BCG naïve adults; and MTBVAC appears safe in a small ongoing Phase 1b~     study in South African newborns. Definitive demonstration of safety and immunogenicity at the~     optimal MTBVAC dose is key to progression into multi-centre efficacy trials in newborns.~      A Phase 2a dose-defining study of MTBVAC to evaluate the safety, reactogenicity,~     immunogenicity, and potential for IGRA conversion and reversion, of MTBVAC in South African~     newborns. Ninety-nine HIV unexposed, BCG naïve newborns will be randomized to receive either~     BCG 2.5 x 105 CFU (n=24) or MTBVAC at one of three dose levels (n=75). Allocation will be~     double blind. Enrolment will be sequential into 3 cohorts of increasing MTBVAC dose (Cohort~     1: n=25 MTBVAC 2.5 x 10E+04 and n=8 BCG; Cohort 2: n=25 MTBVAC 2.5 x 10E+05 and n=8 BCG;~     Cohort 3: n=25 MTBVAC 2.5 x 10E+06 and n=8 BCG). Dose escalation will be staggered to allow~     gradual evaluation of safety; final selection of the dose for Cohort 3 will be based on all~     available safety and immunogenicity data.~   "
2348|NCT03536104|"~     Using this convergence approach from a limited group of subjects with non-diseased controls,~     patients with Parkinson's disease or related diseases, we will be able to limit the number of~     potential genes of specific susceptibility to Parkinson disease. These genes will then be~     studied using a case-control genetic epidemiology approach. The risk of developing the~     disease will then be evaluated according to clinical, biological and environmental variables~     collected in Parkinson's subjects and healthy controls in the second group of subjects. The~     specificity of the genetic associations found will be evaluated in subjects with Parkinson's~     disease.~   "
2349|NCT03536091|"~     In this study the investigators aim to evaluate the ability of i-scan OE together with~     magnification endoscopy to detect and assess microscopic inflammation in patients with~     inflammator bowel diseases (IBD).~   "
2350|NCT03536078|"~     The study is designed as a randomised controlled multicenter study.The primary aim is to~     investigate if home phototherapy improves parent-child bonding compared to if treatment is~     performed at the hospital. The investigators will also istudy how home phototherapy is~     perceived by the parents, impact on breastfeeding and parents stress levels, if the method~     can be implemented etc.~      Patients are included at 5 hospitals in Sweden. The plan is to include 250 term newborns with~     neonatal icterus at a level that needs phototherapy treatment.~   "
2351|NCT03536065|"~     ORIOLES is a pre-post study designed to improve quality of opioid prescribing and use after~     discharge for patients undergoing urologic surgery. The study will initially focus on a~     pre-defined cohort of patients undergoing radical prostatectomy. After the predefined study~     period and results are obtained, the intervention may be applied to all urologic surgeries~     based on the degree of improvement demonstrated by the study.~   "
2352|NCT03536052|"~     The goal of this study is to test the efficacy of the new imaging/simulation (virtual~     heart) approach for determining the optimal ablation sites in patients with VT, which render~     post-infarction VT non-inducible. The study will test both the acute outcome of the ablation~     procedure, and the effect the use of the predicted targets has upon procedure time.~   "
2353|NCT03536039|"~     Patients with primary central nervous system lymphoma (PCNSL) are treated with~     high-dose-methotrexate-based chemotherapy, which requires hospitalization and extensive~     expertise to manage related toxicity. Treatment with R-CHOP, the most commonly used~     combination against aggressive lymphomas, could overcome these difficulties, but CNS~     bioavailability of related drugs is poor due to their limited capability to cross the~     blood-brain barrier (BBB). Tumor necrosis factor (TNF) induces selective BBB permeabilization~     and enhances CNS access of anticancer drugs in animal models. The addition of NGR peptide~     improves biological properties of TNF, resulting in increased drug availability and antitumor~     synergistic effect, without increased toxicity. Thus, the addition of NGR-hTNF to R-CHOP may~     result in improved CNS drug availability and activity in patients with relapsed/refractory~     PCNSL; this hypothesis is being tested in this ongoing phase II trial called INGRID. This~     trial will consider HIV-negative patients (age 18-80 ys; ECOG PS ≤3) with relapsed/refractory~     PCNSL previously treated with high-dose-methotrexate-based chemotherapy± radiotherapy, and~     with measurable disease.~   "
2354|NCT03536026|"~     Despite technological advancements directed towards the diagnosis of peripheral pulmonary~     lesions, an optimal approach has yet to be designed. One significant barrier for the~     bronchoscopic biopsy of peripheral lesions is the ability to reliably locate peripheral~     lesions in an efficient manner. The majority of the published literature regarding peripheral~     lesion biopsy has used diagnostic yield as the primary endpoint. Based on this data, it is~     unclear if non-diagnostic procedures are due to the inability to locate peripheral lesions,~     or due to the inability to successfully biopsy lesions once located using currently available~     instruments. This study will evaluate the bronchoscopists' ability to locate peripheral~     pulmonary lesions by using a conventional chest computed tomography (CT) scan as a reference~     and a virtual bronchoscopic navigational system, if needed, for the localization of~     peripheral pulmonary lesions.~   "
2355|NCT03536013|"~     To evaluate the efficacy of full thickness placental allograft use in Microdiscectomy~     application. To evaluate post-microdiscectomy reherniation rate in patients treated with~     full-thickness placental allografts.~   "
2356|NCT03536000|"~     To assess whether the aCQM-Strain ultrasound method allows a good analysis of fetal cardiac~     function. Establish normality parameters and compare it with fetuses with risk factors of~     cardiac dysfunction.~   "
2357|NCT03535974|"~     Clinical trial with a double-blind, placebo-controlled, crossover design; enrolls~     approximately 30 euthyroid patients with benign thyroid nodules, who will receive for 6 weeks~     a spirulina-based supplement, and for another 6 weeks placebo. Thyroid ecography will be~     performed three times for each patient, and blood tests including TSH, free T4, free T3 and~     ceruloplasmin/Copper will also be performed 3 times for each patient. It is expected that a~     decrease in the thyroid nodules occurs with the supplement administration. Compared with~     placebo there will be a decrease of at least 20% in the volume or the largest diameter of the~     nodules during the 6-week administration of the supplement.~   "
2358|NCT03535961|"~     The hypothesis of this study is to discover if the all-oral therapy with apatinib plus oral~     Etoposide can shrink or slow the growth of pretreated HER2 negative metastatic breast cancer.~   "
2359|NCT03535948|"~     Outcome of Hodgkin lymphoma patients over than 60 years treated by chemotherapy and/or~     radiotherapy: retrospective analysis.~   "
2360|NCT03535935|"~     This add-on open-label randomised controlled pragmatic trial aims to:~        1. evaluate the effect of add-on astragalus treatment on type 2 diabetic patients with~          stage 2 to 3 chronic kidney disease and macroalbuminuria.~        2. estimate treatment effect, variance, recruitment rate, attrition rate and change in~          clinical manifestation including Chinese medicine syndrome for parameters optimisation~          and feasibility assessment for a subsequent phase III randomised controlled trial.~        3. assess response predictors for efficacy and safety among type 2 diabetic patients with~          stage 2 to 3 chronic kidney disease and macroalbuminuria receiving add-on astragalus~          treatment~   "
2361|NCT03535922|"~     Patient-reported outcome measures (PROMs) are reports coming directly from patients about how~     they function or feel in relation to a health condition and its therapy, without~     interpretation of the patient's responses by a clinician or anyone else. PROMs capture~     patients' experiences of symptoms and impact of disease on functioning and can support~     clinicians to monitor disease progression and facilitate patient-centered care.~      The EMPATHY trial will determine the effects of routinely measuring PROMs on the experiences~     of patients undergoing hemodialysis in Alberta and Ontario. In this study, two kinds of PROMs~     will be used: a disease-specific PROM and a generic PROM. The disease-specific PROM focuses~     on health symptoms related to chronic kidney disease and the generic PROM focuses on general~     health.~      In the trial, patients will be invited to complete the PROMs, and results of the measures~     will be linked to treatment aids for clinicians, providing specific information on how~     symptoms can best be managed. These care pathways will also be available to patients not~     receiving PROMs. The main outcome of this study will be patient-clinician communication,~     which will be assessed using a questionnaire called the Communication Assessment Tool. In~     addition to assessing the effect of using these questionnaires on patient-provider~     communication, this study will allow us to explore whether their use affects patient~     management and symptoms, use of healthcare services, and the overall cost of implementing~     these questionnaires in clinical practice.~      Each dialysis unit (including all patients) will be randomized to one of four study groups:~     1) Patients will complete the disease-specific PROM; 2) Patients will complete the generic~     PROM; 3) Patients will complete both the disease-specific and generic PROM; 4) Patients will~     receive usual care.~      Clinicians (in dialysis units randomized to PROMs, groups 1-3) will receive the results of~     the questionnaires completed by the patients. This is intended to trigger the clinician to~     ask the patient about certain symptoms if any exist. All clinicians in all study groups will~     have access to the clinical treatment aids, which are tools that help identify and manage~     certain symptoms that patients might have. For example, people with severe itching will be~     cared for based on a step-wise treatment algorithm. Patients will also receive a report of~     their questionnaire(s) results, with an explanation of what it means.~   "
2362|NCT03535909|"~     This study will assess the ability of a novel optical measurement system to determine changes~     in the hemodynamic status of heart failure patients admitted to the hospital with a primary~     diagnosis of acute decompensated heart failure. Patients will be measured with both the novel~     measurement system and reference devices that are FDA-cleared for hemodynamic measurements.~     The measurements from the novel system will be compared to reference variables describing~     hemodynamic and congestive status, including stroke volume, central venous pressure, and~     serum levels of NT-proBNP.~   "
2363|NCT03535896|"~     The purpose of this study is to investigate the feasibility of combining heavy-slow~     resistance training with an ultrasound-guided corticosteroid injection to reduce pain in~     individuals with plantar fasciopathy. Feasibility will be evaluated using the acceptability~     of the combined interventions and exercise compliance.~   "
2364|NCT03535883|"~     To assess risks of bleeding in those individuals receiving Novel Oral Anti-Coagulant (NOAC)~     medications, admitted to the hospital and require thoracentesis, chest tube or tunneled~     pleural catheter placement.~   "
2365|NCT03535870|"~     A Randomized, Parallel-Group, Placebo-Controlled, Clinical Endpoint Bioequivalence Study of~     Generic Fluticasone Propionate 100 μg and Salmeterol Xinafoate 50 μg Inhalation Powder~     Compared with Advair Diskus® 100/50 in Subjects with Asthma~   "
2366|NCT03535857|"~     This study is designed to evaluate whether bilateral Posterior Tibial Nerve Stimulation is~     more effective than unilateral Posterior Tibial Nerve Stimulation at treating overactive~     bladder and urge urinary incontinence~   "
2367|NCT03535844|"~     This purpose of this study is to assess the impact of consuming wolfberry on cardiovascular~     risk in Singapore's middle-aged and older adults. The investigators hypothesize that~     consuming wolfberry with a healthy eating pattern diet will contribute to improvements in~     cardiovascular health when compared to a similar diet without wolfberry.~   "
2435|NCT03534960|"~     Humidified high flow nasal oxygen therapy decreases dilution of the inhaled oxygen and, by~     matching patient's peak flow, allows accurate delivery of the set FiO2 throughout the whole~     inspiratory phase.The purpose of this study is to determine the impact of hign-flow nasal~     therapy on pediatric hypercapnic respiratory failure by comparing with nasal continuous~     positive airway pressure.~   "
2368|NCT03535831|"~     The purpose of the Princess Margaret Cancer Centre PSMA registry is to assess the~     contribution of 18F-DCFPyL (PSMA) PET imaging (PET/MR or PET/CT) to the management of~     patients with prostate cancer (PCa).~      Background:~      Currently, patients with intermediate or high risk prostate cancer are staged with CT abdomen~     and pelvis and bone scan to assess for distant metastases. Patients with biochemical~     recurrence after primary therapy are restaged in a similar manner. Locally, multiparametric~     MR of the prostate or prostate bed may also be obtained in select cases.~      Patients recruited for this registry will be staged/ restaged with PSMA PET (PET/CT or~     PET/MR) to determine whether this imaging strategy results in more accurate detection of~     metastatic disease (for patients undergoing primary staging) or detection of local recurrence~     or distant disease (for patients undergoing restaging). Choice of imaging method (PET/CT or~     PET/MR) will be made by one of the study PIs, based on clinical judgement taking into account~     the specific exam indication, prior recent imaging, and suitability for MR imaging.~      Study design:~      This is a single arm study to assess the contribution of PSMA PET imaging (PET/MR or PET/CT)~     to the management of patients with prostate cancer (PCa).~      In this prospective trial, the investigators will recruit 200 men whom will undergo PET~     imaging using an integrated PET/CT scanner or with an integrated PET/MR.~      Patients will receive standard treatment for PCa according to UHN/PMH urology oncology site~     policies.~      Treatment outcome including clinical response, blood work including serial serum PSA, and~     follow-up imaging if performed up to 5 years will be recorded.~   "
2369|NCT03535818|"~     Patients with ongoing paroxysmal arrhythmias after pulmonary vein isolation (PVI) for~     paroxysmal and persistent atrial fibrillation (AF) get incrementally less benefit with~     redo-PVI. This implies non-pulmonary vein (PV) triggers, which are more challenging to~     locate. The autonomic nervous system is implicated in the multifactorial pathogenesis of AF~     but few studies have attempted neural targeting as a therapeutic intervention. We have~     demonstrated that stimulation of specific left atrial ganglionated plexi (GPs) triggers both~     AF and atrial ectopy and importantly stimulation of these sites may not induce AV block, the~     'conventional' marker used to locate GPs. Having shown that these ectopy-triggering GP~     (ET-GP) sites are anatomically stable and can be rendered inactive by either ablation at the~     site or by ablation between the site and the adjacent PV, a single centre study suggests that~     ET-GP ablation can prevent recurrent AF in some patients. We propose to test the efficacy of~     adjunctive ET-GP ablation in patients undergoing redo PVI for paroxysmal AF.~   "
2370|NCT03535805|"~     Background~      Impairing emotional and behavioural problems are common in children and adolescents and mark~     a three-fold increased risk of mental disorder in young adulthood. Evidence-based~     psychological interventions are recommended for indicated prevention and first-line~     treatment, but access to treatment is often limited.~      A new, modular cognitive and behavioural therapy program Mind My Mind (MMM) comprising~     evidence-based interventions for children with emotional and behavioral problems was designed~     to be delivered by educational psychologists in the Danish municipalities.~      A feasibility RCT (NCT03448809), demonstrated that the study design was acceptable among~     children, parents, and therapists, and it provided data to estimate the sample size needed~     for the definitive RCT. The investigators test the hypothesis that the parent-reported impact~     of mental health problems will be significantly lower for children in the MMM group as~     compared with children in the TAU group after the 18-week intervention period (primary~     hypothesis), and after follow-up at week 26 (first secondary hypothesis).~      Aim~      To investigate the effects and cost-effectiveness of MMM compared with TAU for children and~     adolescents with impairing anxiety, depressive symptoms and/or behavioral problems. Both~     beneficial and harmful effects are evaluated.~      Methods~      The study compares the new modular MMM with TAU for children aged 6-16 years with anxiety,~     depressive symptoms or behavioral problems impacting on their daily and social life. The~     trial is conducted in four Danish municipalities in the period from September 2017 to April~     2019. Participants are children with indicated needs.~      The parents sign up the child for assessment in the Pedagogical Psychological Services in the~     Municipalities. The assessment includes web-based standardized questionnaires for child and~     parent: 1) the strengths and difficulties questionnaire (SDQ), 2) Spence Children's Anxiety~     Scale, 3) Mood and Feelings Questionnaire, and 4) family, social and school functioning. The~     questionnaires are supplemented with a clinical psychopathological interview by a trained~     psychologist. The investigators exclude children with 1) low levels of problems and no~     indicated needs, or 2) high levels of problems and need of referral to the Child and~     Adolescent Psychiatry.~      412 children will be included and randomized (1:1) to MMM versus TAU. MMM is supported by a~     central organization, who is responsible for the education and weekly supervision of the~     therapists, and the web-based data collection and feedback of data in real time to therapists~     and researchers. All outcomes are self-, parent- and teacher-reported scores on standardized~     questionnaires administered at baseline, week 18 and week 26. At entry, the child and the~     parents own description of the Top-problem is recorded and scored on a 10-point likert scale.~     The Top-problem and impact of problem is scored by parent and child every second week during~     the intervention period, and the progress is monitored by the therapists in the MMM group.~     Information on costs is gathered through administrative registers and questionnaires at~     baseline, week 18, and week 26.~      Primary objectives and outcome measures~      This primary outcome is measured with the parent-reported SDQ impact-scale. The minimum~     relevant difference in impact of mental health problems was set at 1.0 corresponding to a~     change from severe to moderate, or from moderate to little-or-no impact in one of five~     domains of child's life: distress, home-life, friendships, classroom learning and leisure~     activities.~      Secondary objectives and outcomes measures~      The key secondary hypotheses are that the children in the MMM group will show significantly~     lower levels of parent-reported anxiety, depressive symptoms, functional impairment,~     Top-problems and behavioural problems, and better school attendance and quality-of-life as~     compared with the children in the TAU group at week 18.~      All other outcomes are explored at week 18 and 26, including the primary and secondary~     measures of potential harm: 1) youths with severe and increased levels of self-reported~     suicidality, hopelessness and/or negative self-evaluation, and 2) youths with poor quality of~     life in relation to family, free time and friends.~      Statistical analyses~      All analyses will be intention-to-treat with two-sided significance tests. The investigators~     will use mixed models with repeated measures for continuous outcomes and generalized linear~     mixed model for binary and non-normally distributed outcomes. For the key secondary outcomes,~     the investigators will use the strategy of hierarchical testing allowing us to preserve the~     level of significance, α=0.05, as long as the null hypotheses are rejected. The incremental~     cost-effectiveness ratio will be calculated to analyze cost-effectiveness.~      Perspectives~      The results will guide policy makers in deciding whether to implement modular CBT-programs~     like the MMM.~   "
2371|NCT03535792|"~     The Efficacy Of Nalbuphine Versus Fentanyl As Additives To Bupivacaine In Spinal Anaesthesia~     For Internal FixationI Of Tibia~   "
2372|NCT03535779|"~     This study is an exploratory single site sample collection study at St Mary's hospital~     campus, Imperial College London. Sixteen participants scheduled to receive routine~     immunizations for Td/IPV (group 1) and HBsAg (group 2) will be recruited overall. Eights~     participants will be allocated to group 1 and eights participants to group 2 depending on~     their immunisation regime.~   "
2373|NCT03535766|"~     This study is a single center, minimal risk, physician initiated retrospective chart review.~     An analysis of treatment timelines for patients diagnosed with lung cancer within the St.~     Elizabeth system from January 2013 until study completion. The study investigator and~     designee(s) will review patient electronic medical records, extracting data related to the~     symptom presentation, diagnosis, and treatment of new diagnoses of lung cancer. Collected~     data will focus on dates of encounters, diagnostic imaging/procedures, and treatments, with~     data analysis evaluating time between care encounters and potential delays in care. The data~     will be further stratified based on system-wide changes implemented to improve efficiency,~     patient outcomes, and patient experience.~   "
2374|NCT03535753|"~     Assessment of the Safety and efficacy of Administering decitabin plus R-GDP to NHL patients~   "
2375|NCT03535740|"~     The primary purpose of this study is to determine the efficacy of brigatinib by confirmed~     objective response rate (ORR) by response evaluation criteria in solid tumors (Response~     Evaluation Criteria in Solid Tumors [RECIST]), in participants with ALK+ locally advanced or~     metastatic NSCLC whose disease has progressed on therapy with alectinib or ceritinib.~   "
2376|NCT03535727|"~     The purpose of this study is to evaluate the clinical activity of gemcitabine,~     nab-paclitaxel, capecitabine, cisplatin, and irinotecan (GAX-CI) in patients with metastatic~     pancreatic cancer.~   "
2377|NCT03535714|"~     The aim of this study is to test effectiveness of a new treatment program for adolescents and~     young adults within the age of 14-21 suffering from AN (MANTR-a) compared to treatment as~     usual (TAU).~   "
2378|NCT03535701|"~     This pilot clinical trial studies how well a ketogenic diet and chemotherapy work in~     affecting the return of cancer in patients with stage IV breast cancer. Ketogenic diet may be~     more effective than standard nutrition and may affect quality of life, inflammation, and~     tumor-related changes. Drugs used in chemotherapy, such as paclitaxel, work in different ways~     to stop the growth of tumor cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Giving ketogenic diet and chemotherapy may be~     better in patients with breast cancer.~   "
2379|NCT03535688|"~     The purpose of this study is to evaluate the efficacy and safety of D-cycloserine versus~     placebo in relieving the signs and symptoms of patients with chronic lower back pain.~   "
2380|NCT03535675|"~     This research is being done to determine if men with rising PSA after initial therapy for~     localized prostate cancer who display the Alanine/Alanine SOD2 genotype of MnSOD and~     supplement their diet with MPX have greater decrease in PSA slope following treatment~     compared to men that do not supplement with MPX.~   "
2381|NCT03535662|"~     A Phase 1 study to assess the effect of itraconazole, a strong inhibitor of CYP3A and~     P-glycoprotein, on the pharmacokinetics (PK) of orvepitant in healthy male volunteers.~      Subjects will receive two single doses of 20mg orvepitant, once alone and once in combination~     with repeat doses of itraconazole. All subjects will follow the same sequence - orvepitant~     alone followed by orvepitant in combination with itraconazole.~   "
2382|NCT03535649|"~     The purpose of this study is to assess the clinical effectiveness by the clinical response at~     6 weeks and the safety of vedolizumab intravenous in UC Korean participants.~   "
2383|NCT03535636|"~     The aim of this study is to examine sleep structure in refugees with PTSD. Polysomnography~     (PSG) will be carried out to study the occurrence of sleep disorders in patients and healthy~     controls.~   "
2384|NCT03535623|"~     Remote ischemic preconditioning (RIPC) has shown organ-protective effects in many clinical~     settings including patients with ischemic heart disease. However its protective role in head~     and neck cancer patients with preoperative radiotherapy undergoing free flap reconstructive~     surgery has not yet been evaluated. The purpose of the current study is to evaluate the~     effect of RIPC on tissue oxygen saturation and skin temperature of the flap, as well as its~     organ-protective effects using Langendorff isolated heart ischemia-reperfusion model.~   "
2385|NCT03535610|"~     To evaluate the therapeutic response to uterine artery embolization in 30 patients with~     leiomyoma using the microspheres Embosoft (Embosoft® - Scitech Medical).~   "
2386|NCT03535597|"~     To evaluate the efficacy and safety of the QuikClot® Radial® pad on hemostasis after TRA,~     compared to the standard of care TR Band®, with the goal to hopefully develop a safe and~     efficacious technique to achieve more rapid patent hemostasis after TRA, and improve patient~     care by optimizing radial hemostasis management.~   "
2387|NCT03535584|"~     Frailty is a condition characterized by slowness, weakness, low physical activity, wasting,~     and exhaustion. Frailty increases the risk for adverse outcomes following transplant such as~     increased length of stay in the hospital, mortality, or graft function. No interventions for~     frailty are known for patients with renal disease, but exercise programs like pulmonary~     rehabilitation have been effective in improving frailty in patients with other diseases, such~     as lung disease. The goal of this study is to test whether exercise will also improve frailty~     among patients who are waiting for a kidney transplant and who are considered frail or~     pre-frail.~   "
2388|NCT03535571|"~     The objective of this study is to evaluate the efficacy of Salmon Protein Hydrolysate Powder~     (CollaGo®) on energy increase and anti-inflammatory modulation in healthy males and females.~     Eligible participants will be asked to consume 1 sachet of CollaGo for 128 days and keep a~     study diary. Assessments will be measured at the randomization visit, and the end of study~     visit.~   "
2389|NCT03535558|"~     The purpose of this study is to: 1) describe drug utilization for Fluoroquinolone(FQ),~     Azithromycin (AZ) and Sulfamethoxazole/Trimethoprim(ST) in the entire Truven MarketScan~     Commercial Claims and Encounters database (CCAE) database, and specifically among individuals~     in the Health and Productivity Management (HPM) during the observation period; 2) describe~     the rate of disability associated with 2 or more System Organ Class adverse events (SOC AEs)~     and exposure to FQs for several acute, uncomplicated indications; and 3) compare the rates of~     disability for 2 or more SOC AEs and exposure to FQs and AZ/ST for the same indications.~   "
2390|NCT03535545|"~     The goal of this study is to investigate the safety of [68Ga]CBP8 and its efficacy to detect~     collagen deposition in pulmonary fibrosis.~   "
2391|NCT03535532|"~     ULARH is a 2-arm, prospective, open-labeled, multi-center randomized clinical trial.The~     purpose of this study is to compare the effectiveness of medical treatment and unilateral~     laparoscopic adrenalectomy for resistant hypertension in patients diagnosed with adrenal~     disease based on imaging tools.Relative ratio of end-point events occurence in three years is~     considered as primary outcome. Furthermore, we will exploit clinical factors which could~     indicate a favorable outcome in participants who accepted surgical treatment in this study.~   "
2392|NCT03535519|"~     Observational and prospective study of the ultrasound response to methotrexate in rheumatoid~     arthritis patients who started methotrexate~   "
2393|NCT03535506|"~     This is a feasibility study which will evaluate the effects of pre-operative treatment of~     DCIS of the breast with palbociclib. Patients with biopsy-proven DCIS are eligible for the~     study.~      There will be 2 independent and unrelated study groups of 12 patients each, for a total of 24~     patients:~        1. Group A, of male or female patients treated with palbociclib single agent (n=12);~        2. Group B, untreated, of male or female patients who consented translational studies in~          blood, as well as diagnostic and definitive surgical specimen, but not the pre-operative~          treatment with palbociclib (n=12).~   "
2394|NCT03535493|"~     In 1982, Steven Hayes, a clinical psychologist, developed Acceptance and Commitment Therapy~     (ACT), a unique empirically based psychological intervention that uses acceptance and~     mindfulness strategies, together with commitment and behavior change strategies, to increase~     psychological flexibility. In 1954, John Lilly, a cognitive neuroscientist, developed the~     sensory deprivation tank (known today as Floatation Restricted Environmental Stimulation~     Therapy - Float REST), to access a wide range of healing, higher brain functions, and~     meditation through an unparalleled deep relaxation state. In this study, the investigators~     aim to examine whether participants in the ACT + Float REST condition will have larger~     decreases of the burnout phenomenon than those who receive either only ACT or Float REST.~   "
2395|NCT03535480|"~     This study aims to recover ovarian function in POF/POI patients. With this pueprose we~     designed a study protocol including two arms: ASCOT arm, were patients receive the stem cell~     mobilization treatment with Granulocyte colony stimulating factor (G-CSF) followed by~     apheresis and ovarian artery catheterism to selectively infuse the stem cells into the ovary~     and the G-CSF arm including patients that receive the mobilization treatment but not the~     ovarian artery catheterism to selectively infuse the cells into the ovary.~   "
2396|NCT03535467|"~     Caregiver's burden in rehabilitation is important for both patients physical and mental~     health. Therefore researching caregivers burden and treatment of any depression or associated~     any psychological disorders of caregiver is crucial.~   "
2397|NCT03535454|"~     The research is about fibromyalgia prevalency in working population and searching~     work-related fibromyalgia.~   "
2398|NCT03535441|"~     It is reported that high mobility group box 1 (HMGB1), a non-histone nuclear protein, can~     serve as an alarmin with damage associated molecular patterns to activate immune responses in~     the early stages of hemorrhagic shock (HS). However, the origin of HMGB1 and how it is~     released following HS is poorly understood. In this study, we teased out this mechanism. We~     try to record the concentration of serum HMGB1 protein following HS in clinical patients.~   "
2436|NCT03534947|"~     In this study, patients with BCC will be given neoadjuvant treatment with a drug called~     sonidegib. Sonidegib is a daily tablet usually given for BCC that cannot be removed by~     surgery or that has spread through the body. The study aims to see if sonidegib given for 12~     weeks will reduce the size of tumours so surgery results in less scarring or may be avoided,~     with only short term topical treatment required to treat remaining tumour.~   "
2399|NCT03535428|"~     Pelvic fracture surgery are very high thrombotic risk surgery with about 10% to 50% venous~     thrombo embolic complications and 0.5% to 10% of pulmonary embolism. The ST JOSEPH's Hospital~     have almost 60 cases per year . Following a fatal pulmonary embolism per operatory the team~     has set up a venous exploratory protocol before surgery.~      This protocol includes a venous doppler ultrasound of lower limbs associated to a abdo pelvic~     scanner in the 48hours before surgery.~      The aim is to evaluate this new protocol efficacy on prevention of thrombo embolic~     complications in pelvic fracture surgery.~   "
2400|NCT03535415|"~     This study aims to evaluate the efficacy and safety of recombinant human growth hormone~     injection in short stature children due to chronic kidney disease before transplantation.~   "
2401|NCT03535402|"~     This is a single site study to determine the structural efficacy of sarilumab when~     administered to biologic naive patients with active rheumatoid arthritis~   "
2402|NCT03535389|"~     To compare the radiological parameters measured by dynamic four dimensional CT (4DCT) in the~     analysis of patellofemoral involvement of subjects (amplitude of patellofemoral tilt angle~     variations, coefficient of variation of the same angle, distance of lateral displacement of~     the patella ) in patients with patellofemoral clinical syndrome to those free of this~     syndrome (= control group).~      It is expected that the amplitude of patellofemoral tilt angle changes, its coefficient of~     variation, and the patella lateral displacement distance differ between the 2 groups~     compared. This result would clarify the potential value of dynamic 4D CT in the diagnosis of~     PFI~   "
2403|NCT03535376|"~     Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the~     pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the~     pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery.~     Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological~     availability of medication. In this study the pharmacokinetic effects of bariatric surgery on~     valsartan are investigated.~   "
2404|NCT03535363|"~     Investigating potential of controlling brain metastases in patients with EGFR positive NSCLC.~   "
2405|NCT03535350|"~     Safety of combination of ibrutinib and radiation at various dose levels in unmethylated~     o6-methylguanine-DNA-methyltransferase (MGMT) glioblastoma and study of ibrutinib,~     temozolomide, and radiation combination therapy in methylated MGMT glioblastoma.~   "
2406|NCT03535337|"~     The purpose of this study is to test an adaptive adherence intervention, which utilizes two~     mobile health (mHealth) intervention designs, in an effort to promote adherence to~     antiretroviral therapy (ART) and achieve and maintain viral load (VL) suppression in youth~     living with HIV (YLH) while increasing understanding of the context for wide-scale~     implementation of cell phone support (CPS) and text messaging support (SMS), with and without~     incentives.~   "
2407|NCT03535324|"~     Patients with negative blood cultures represent 85-90 % from all patients with a blood~     culture taken during hospital admissions. This population usually includes an heterogeneous~     group of patients that are admitted because of an infectious diseases or febrile syndrome in~     which performing a blood culture is required. There is scarce evidence about the clinical~     characteristics and the antibiotic treatment given to these patients. This project will be~     developped in two phases with an specific target in each one:~        -  Phase I (a cohort study of patient with blood cultured taken): the investigators aim to~          analyse the clinical and therapeutics characteristics, outcomes and antimicrobial~          stewardship oppotunities in a population of patients with negative blood culture. The~          investigators aim to compare the outcomes and antimicrobial stewardship opportunities~          with those in patients with positive blood culture.~        -  Phase II: The investigators will develop a cluster randomised control trial to evaluate~          the implementation of a targeted antimicrobial stewardship intervention in patients with~          negative blood culture (based on 3rd and 5th day audits). The effect of the intervention~          on the quality of antimicrobial use (duration and de-escalation), long of stay and~          mortality will be analysed.~   "
2408|NCT03535311|"~     Insertion Length of Umbilical Catheters~      Umbilical catheters, inserted through the umbilical artery and vein of newborn babies at~     birth, are crucial in neonatal care of sick babies. They allow delivery of medication and~     fluids and to provide access for blood sampling and blood pressure monitoring. Incorrect~     positioning of the catheter tip due to under- or over-insertion length can lead to~     significant complications in newborn infants. Currently, several methods are used to estimate~     insertion length of umbilical catheters based on one of two beliefs; that the insertion~     length of the umbilical catheter is proportional to either the infant's birth weight or an~     external length measurement.~      Several research studies have identified that existing methods often result in incorrect~     positioning of umbilical catheters, with studies showing a variable range of proportions of~     umbilical lines being correctly or incorrectly placed.~      In particular, formulas for predicting umbilical venous catheter (UVC) length have been shown~     to be particularly unreliable.~      The investigators propose a new observational study which uses a novel but easy-to-measure~     external length measurement, the sternal notch (upper end of breast-bone) to umbilicus (upper~     margin of belly-button) length, along with other clinical information to develop a more~     reliable formula for estimating the insertion length of umbilical venous and arterial~     catheters to an appropriate length.~      Our study population will include newborn babies admitted to the neonatal unit requiring~     umbilical venous (UVC) and/or arterial catheterisation (UAC) over a two-year period.~     Demographic information will be recorded for each child and once position has been confirmed,~     the new external length will be measured. New formulae for estimating required insertion~     length will be developed using statistical (regression) analysis.~   "
2409|NCT03535298|"~     The DELIVER-MS study seeks to answer the question: Does early treatment with highly effective~     DMT improve the prognosis for people with MS? This is an area of significant controversy and~     no data currently exist to guide treatment choices for patients and clinicians. The study~     results will help guide overall treatment philosophy and will be applicable not only to a~     wide range of existing therapies but also to new therapies, meeting a significant unmet need~     in patient decision making and aiding the decision for medication approval by third parties.~   "
2410|NCT03535285|"~     Surgical modification technique try to get bodily movement during upper canine retraction.~   "
2411|NCT03535272|"~     The purpose of this study is to determine if the use of prophylactic bismuth subsalicylate~     (BSS) has an effect on the acquisition of travelers' diarrhea (TD) or antimicrobial~     resistance (AMR) genes in fecal samples among international travelers who departed from the~     United States to South East Asia, South Central Asia, or Africa. Our hypotheses will be~     tested using a double-blinded, placebo controlled randomized clinical trial with participants~     from a pre-travel health clinic in the United States.~   "
2546|NCT03533504|"~     Using anonymized patient data collected as part of the WAPPS-Hemo project to explore the~     sources of variability in individual pharmacokinetics (PK); use the sources of variability to~     improve the performance of the WAPPS-Hemo models through the addition of the predictors of PK~     variability as covariates.~   "
2412|NCT03535259|"~     This is a single-arm phase II clinical trial to investigate the efficacy and toxicity of~     concurrent sorafenib and intensity-modulated radiotherapy (IMRT) for advanced hepatocellular~     carcinoma with portal vein or hepatic vein tumor thrombosis or lymph node involved.~     Eligibility patients will receive IMRT to hepatic primary tumor, vein tumor thrombosis, and~     metastasis lymph node with concurrently sorafenib with a dose of 400mg twice daily.~     Prescription of IMRT will be a conventional fraction dose of 2Gy to a total dose of 40 to~     60Gy. Sorafenib will be maintained with a dose of 400mg twice daily after IMRT until disease~     progression, or unacceptable adverse events. Six months of sorafenib maintenance is~     recommended.~   "
2413|NCT03535246|"~     The primary objectives are to evaluate the safety and efficacy of infusion of autologous~     tumor associated antigen-specific engineered immune effector cells (EIE).~   "
2414|NCT03535233|"~     Alopecia areata (AA) presents with circumscribed patches of non-scarring hair loss. It~     inflects a significant psychological and social burden. Many treatment options are used for~     the treatment of AA. Randomized controlled trials comparing intralesional and topical therapy~     and comparing combinations are few.~      The aim of this work is to evaluate the efficacy of combined topical 5% minoxidil and potent~     topical corticosteroid therapy compared to intralesional triamcinolone injection in alopecia~     areata~   "
2415|NCT03535220|"~     This is a multicenter, retrospective and prospective, long-term registry of patients with~     benign or malignant hematologic diseases, whether or not these patients were or were not~     treated with disease-specific treatments. Information will be collected on patient~     demographics, disease characteristics, genomic and molecular data, laboratory data,~     pathology, radiographic reports, clinical status, quality of life, medications, and dosing~     information. Where appropriate, these data structures may be based on a combination of Fast~     Healthcare Interoperability Resources (FHIR) , Consolidated-Clinical Data Architecture~     (C-CDA) and/or client-speciﬁc structure deﬁnitions.~   "
2416|NCT03535207|"~     To assess the efficacy and feasibility of high-dose intensity-modulated radiotherapy with~     concurrent weekly paclitaxel and cisplatin for patients with locoregionally advanced~     esophageal cancer~   "
2417|NCT03535194|"~     The reason for this study is to see how effective and safe mirikizumab is compared to~     secukinumab and placebo for moderate to severe plaque psoriasis.~   "
2418|NCT03535181|"~     Intracranial aneurysm are frequent with a prevalence estimated over 2-5% in the general~     population. These are focal dilatations occuring in the cerebral vessels. They usually remain~     silent until complications occur. Complications associated with intracranial aneurysms~     include mass effect on adjacent structures and rupture. Rupture is the most severe~     complication with a mortality rate of 35-50% and a high rate of morbidity including long-term~     disability. It incidence is estimated about 1% per year for aneurysm smaller than 1 cm.~      However, preventative treatments have their own risk of complication and morbi-mortality rate~     including stroke and hemorrhage. Actual guidelines for treatment planning are mainly designed~     with the size, the location and the age of the patient. This is why working on the~     identification of imaging markers of aneurysmal instability is relevant.~      Dynamic CTA (Computed Tomography Angiography) acquisition allow to study the variation of~     metrics such as dome height, dome length, ostium width, ostium area, and volume during the~     cardiac cycle. The goal of this study is to assess different aneurysmal metrics to determine~     those which may vary the most during the cardiac cycle and to assess it as an imaging marker~     of aneurysmal instability.~   "
2419|NCT03535168|"~     The primary objectives of this study are to:~        -  Investigate the safety and tolerability of ascending repeated oral doses of BAY1902607~          in healthy subjects (Part 1).~        -  Investigate the effect of BAY1902607 on the pharmacokinetics (PK) of a sub-therapeutic 1~          mg dose of midazolam (Part 1).~        -  Investigate the safety, tolerability and efficacy of BAY1902607 in patients with~          refractory chronic cough (Part 2).~   "
2420|NCT03535155|"~     The overall aim of this study is to develop an automated spinal landmark identification~     system to improve patient safety and efficacy of neuraxial procedure needle insertion~     success.~      This is a prospective cohort study to evaluate the accuracy of the automated spinal landmark~     identification technique using image processing system based on identification by experienced~     investigator using ultrasound in subjects requiring spinal anesthesia.~   "
2421|NCT03535142|"~     Prospective non-randomized intervention case control study on patients with a BMI > 35. The~     intervention group/cases (n=600) is comprised of bariatric patients who undergo bariatric~     surgery and the control group (n=600) of age, weight and comorbidity matched patients who~     choose not to undergo bariatric surgery. The overall aim is to examine prevalence of the~     spectrum of fatty liver disease (NAFLD) in these patients and the prognostic significance of~     NAFLD.~   "
2422|NCT03535129|"~     Background:~      Problem drinking affects nearly half the people who drink alcohol. Drinking alcohol affects a~     person s social behavior and brain structure, but researchers don t have a good understanding~     of how. They want to test a technique called neurofeedback to learn more about how to treat~     problem drinking.~      Objectives:~      To study what happens in the brains of people who drink alcohol when they look at pictures of~     social things and of alcohol. To learn if people can control brain activity in a magnetic~     resonance imaging (MRI) scanner and if this helps people with drinking.~      Eligibility:~      Adults ages 21 65 who have an alcohol use disorder.~      Healthy volunteers ages 21 65~      Design:~      Participants will be screened with~      Physical exam~      Medical history~      Blood, urine, and heart tests~      Mental health interview~      Questions about their alcohol drinking.~      At each session, participants will have:~      A urine test for drugs and pregnancy. If they test positive, they cannot participate.~      A breath alcohol test and assessment for alcohol withdrawal.~      Participants will complete surveys, talk to researchers about behaviors, and play games.~      Participants will have MRI brain scans. The scanner is a metal cylinder in a strong magnetic~     field. They will lie on a table that slides in and out of the scanner for 1 2 hours.~      Participants will do tasks in the scanner:~      They will look at pictures, sometimes of alcohol.~      They will try to hit a goal. Some participants will get feedback during this task. They will~     see how their brain activity changes or how someone else s changes.~      Participants may have follow-up phone questions at least 3 times over about 6 months.~   "
3458|NCT03521596|"~     Multicenter retrospective and prospective observational study including patients with WM or~     IgM-MGUS evaluated at the time of diagnosis and during the disease course using highly~     sensitive techniques.~   "
2423|NCT03535116|"~     It has been a longstanding teaching in plastic surgery that intra-operative ketorolac use for~     postoperative pain control increases hematoma and bleeding in breast reduction surgery.~     However, there is no literature that supports this teaching. Ketorolac is used routinely in~     free flap reconstruction including breast reconstruction as well as many other surgeries~     including hand surgery without increased risks of hematoma or bleeding. Ketorolac has been~     shown to give good postoperative pain control. The object of this study is to look at whether~     ketorolac increases the rate of hematoma/bleeding in breast reduction. If there is no~     increased risk of hematoma, then ketorolac can be used safely for postoperative pain control~     with an increased risk of hematoma/bleeding. Normally, without using ketorolac, the hematoma~     rates in a breast reduction are 1-2%.~   "
2424|NCT03535103|"~     Brief Summary: LM001 is a recombinant human Follicle Stimulating Hormone (r-hFSH) Injection,~     which is proposed for Assisted Reproductive Technology (ART). This is a randomized,~     open-label, two-period, two-crossover study to evaluate the safety and pharmacokinetics of~     recombinant human follicle stimulating hormone injection (LM001), compared with Gonal-F®,~     both given subcutaneously.~   "
2425|NCT03535090|"~     The alterations of coagulation and fibrinolysis parameters have been described in patients~     with endogenous Cushing's syndrome (CS) and those treated with glucocorticosteroids (GCs).~     The change in hemostatic process is associated with an increased risk of venous~     thromboembolic events (VTE) and pulmonary embolism (PE). Anticoagulation prophylaxis reduces~     thromboembolic complications in endogenous and exogenous hypercortisolism. The impact of the~     intravenous GCs therapy on hypercoagulability, however, remains unclear and perplexing.~     According to the European Group On Graves' Orbitopathy (EUGOGO), patients with active,~     severely symptomatic and sight-threatening Graves' orbitopathy (GO) should be treated with~     high dose intravenous methylprednisolone (IVMP) pulses. There are, however, reports of fatal~     side effects that may be associated with this therapy (e.g.: PE, myocardial infarction,~     severe cerebrovascular events, acute liver damage and sudden death). For this reason, the~     cumulative dose of IVMP should not exceed 8 g within each treatment course, and pulses should~     not be given on consecutive or alternate days, except for the case of dysthyroid optic~     neuropathy. Nevertheless, even smaller cumulative therapy may be associated with fatal~     cardiovascular complications. Hence the aim of our study was to evaluate the effects of IVMP~     therapy on hemostatic process in patients with GO. All of patients were treated according to~     EUGOGO recommendations with standard doses of methylprednisolone with standard recommended~     schedule. Inclusion criterion for the therapy was according to EUGOGO guidelines~     moderate-to-severe and active GO (12 pulses of IVMP 6x0.5g followed by 6x0.25g every week).~   "
2426|NCT03535077|"~     The goal of the SFI is to provide non-invasive information about tissue remodeling occurring~     during melanocytic transition and atypia development in the skin~   "
2427|NCT03535064|"~     Research Problem:~      Upper respiratory infections (URIs) are a common reason for absence from schools as it is~     estimated that children get six to eight episodes every year. In Jazan (2013-2014), 34% of~     primary health care centre attendees who were complaining of URIs were under 15 years old and~     42% of them were positive when tested for viruses by nasopharyngeal swabs. An intervention~     for URIs prevention is hand hygiene, as it has been shown to have an impact on reducing the~     risk of respiratory infections by 50% among children in Karachi, Pakistan by encouraging hand~     washing with soap. Another randomised controlled trial study conducted in Spain among primary~     school students showed a statistically significant 38% reduction in the absenteeism rate due~     to URIs in the intervention group who received education about hand hygiene and used hand~     sanitisers which were distributed among schools. Also, the Chinese conducted a cluster~     randomised control trial evaluating the effect of a hand washing programme and revealed a 38%~     reduction in absence due to URIs among primary schoolchildren.~      This preventive measure is questionable, as a randomised controlled trial done among primary~     school students in New Zealand revealed that encouraging the use of hand sanitisers in~     schools did not have an impact on reducing acute respiratory infections or absenteeism. The~     questionable effect was also documented in a systematic review and meta-analysis for~     randomised controlled trials about the effectiveness of hand hygiene in decreasing absences~     through illness in educational settings.~      Research Significance:~      Appropriate hand hygiene is recommended as a non-pharmacological preventive measure against~     respiratory infections. But this preventive measure is questionable as the results of~     randomised controlled trials about the effectiveness of different hand hygiene interventions~     in reducing absence due to upper respiratory tract infection in different educational~     settings are controversial. Furthermore, previous studies of hand hygiene interventions were~     low in quality and it is recommended to improve future studies relating to it. Also, there is~     no research on the effectiveness of these measures in Saudi Arabia. So, this piece will add~     new knowledge to local and international literature. In addition, this study may help the~     school health administration to develop a hand hygiene programme.~      Objectives:~        -  To determine if hand hygiene education is associated with school absence rates due to~          URIs reduction among primary schoolgirls in Riyadh city, 2017-2018~        -  To measure post-intervention total primary schoolgirl's absence rate (both groups) in~          Riyadh city, 2017-2018.~        -  To measure post-intervention primary schoolgirls' absence rate due to upper respiratory~          infections (both groups) in Riyadh city, 2017-2018.~      Methodology:~      Cluster RCT will be conducted among primary schoolgirls attending public schools in Riyadh~     city in the first education semester. Sampling will be multistage to end up with four~     schools. 616 schoolgirls who are attending the selected classes will be invited to the study.~     Two schools will be randomly assigned to the intervention, which includes one-hour hand~     washing workshop at the beginning of the study, in addition to posters. Parents will~     self-administer the questionnaire at baseline, in addition to a follow-up phone interview~     questionnaire.~   "
2428|NCT03535051|"~     The aim of our clinical trial was to find out whether fractional CO₂ laser sessions in~     combination with application of daily topical tacrolimus 0.03% would enhance the action of~     the drug and pose as a possible combination treatment option for stable vitiligo lesions. We~     applied this combination treatment on one side of the body and compared the response to the~     response of the lesions on the other side of the body to daily topical tacrolimus 0.03%~     alone, which we used as control.~   "
2429|NCT03535038|"~     This study aimed to know the consistency of intravascular volume measurement using USG of IVC~     compared to VPW chest x-ray~   "
2430|NCT03535025|"~     The investigator's study is designed to evaluate the recovery of patients receiving~     anaesthesia for surgeries; in different domains like the physiological, nociceptive,~     cognitive and emotional to the participants' preoperative state.~   "
2431|NCT03535012|"~     Over the past 10 years, there have been substantial improvements in breast reconstruction by~     plastic surgeons, and much has been achieved in aesthetic restoration after mastectomy.~     Advances in both microsurgery and implants have allowed for a wider variety of surgical~     methods, and procedural skills that minimize donor site complications have been developed.~      With such satisfactory aesthetic results, interest has recently increased not only in breast~     reconstruction but also in sensory recovery. Due to the growing expectation of patients,~     sensory discomfort may decrease overall patient satisfaction with breast reconstruction~     despite good aesthetic results. Hence, for qualitative improvement of breast reconstruction~     surgery, efforts must be made to restore sensation in the reconstructed breast. There has~     been little research on the mechanism of sensory recovery despite its clinical importance.~     This study aimed to compare the degree of sensory recovery in the reconstructed breast using~     various reconstruction methods as well as to evaluate the status of neural regeneration with~     harvesting the tissues when nipple reconstruction is performed.~   "
3459|NCT03521583|"~     The primary aim of this study is to prospectively investigate the current bleeding tendency~     of children and adults with VWD.~   "
2437|NCT03534934|"~     The goal of this translational study is to establish a newly emerging CT-based tool for the~     characterization of changes in bone micro-architecture and assessment of their implications~     for fracture-risk in a population of COPD patients at risk for osteoporosis. The tool will be~     suitable and generalizable across emerging CT scanners from different vendors, and it will~     provide a more structurally-based assessment of osteoporosis and bone loss than is provided~     by simple bone density measures. The study will characterize the impact of different~     COPD-related factors on bone structure, and their implications for fracture-risk, leading to~     the development of a COPD-specific model for assessment of fracture-risk that will utilize~     patient-specific demographic, clinical and radiographic data, and CT BMD at the spine, as~     well as bone structural measures at the wrist and/or ankle.~   "
2438|NCT03534921|"~     This study aims to identify the determinants of diabetes and to explore variation in diabetes~     outcomes for people with severe mental illness (schizophrenia, schizoaffective disorder and~     bipolar disorder) in order to develop potential healthcare interventions that can be tested~     further.~      The study utilises a mixed methods design comprising analysis of patient primary care records~     and interviews with patients living with comorbid SMI and diabetes, family carers and~     healthcare professionals involved in commissioning or delivering healthcare for this~     population. This entry on the Protocol Registration and Results System describes only the~     quantitative Work Package of the study in detail i.e. analysis of patient primary care~     records.~   "
2439|NCT03534908|"~     Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in~     the world. NAFLD is associated with a lot of comorbidity, such as diabetes, metabolic~     syndrome, coronary heart disease and chronic kidney diseases. However, the correlation~     between the NAFLD and cardiovascular disease (CVD) events remains controversial. This study~     is an observational study based on a big retrospective cohort in china to explore the~     prevalence of NAFLD in China, the risk factors associated with NAFLD, as well as whether~     patients with NAFLD are more prone to experience CVDs and CVD events.~   "
2440|NCT03534895|"~     To investigate whether midazolam has any effect on postoperative pain in outpatient surgery,~     the investigators will assess the impact of different midazolam doses on pain scores 24h, 7~     days and 3 months after ambulatory surgery.~      The investigators hypothesize that patients being administered higher midazolam doses will~     refer more pain.~   "
2441|NCT03534882|"~     A target for glaucoma treatment is the intra-ocular pressure (IOP) which is lowered with~     medications, laser, or surgical intervention. The efficacy of different medication classes is~     well understood as their IOP lowering effects have been well documented. However, beyond the~     basic biochemical and pharmacokinetic actions, long-term effects of these drugs on IOP have~     not been adequately studied. Specifically, does long-term use of anti-glaucoma medications~     have lasting effects on IOP even with subsequent discontinuation of the medication? In~     Ontario, prostaglandin analogues are the most frequently prescribed first line anti-glaucoma~     medication. In our study, we examine the lingering IOP-reducing effects of the prostaglandin~     analogue anti-glaucoma drug class. Our overall objective is to determine if patients~     previously treated with prostaglandin analogues remain within acceptable treatment ranges 6~     weeks after medication discontinuation, and if this IOP differs from pre-treatment baseline~     values. Half of participants will discontinue their prostaglandin analogue (PGA) treatment~     for 6 weeks, while the other half will continue their PGA therapy as prescribed by their~     ophthalmologist. Both groups will be followed closely throughout the 6 weeks to monitor~     changes in IOP. This can help us understand the lasting effects of medication use and can~     help better guide clinical care in optimizing glaucoma management, and help direct study~     designs of future research that involve any therapy secondary to prostaglandin analogue~     treatment.~   "
2442|NCT03534869|"~     Background: Episiotomy is performed in up to 30% of vaginal deliveries. Previously, pain~     treatment following episiotomy has relied on non-steroid anti-inflammatory drugs (NSAID) as~     analgesics, whose use during breastfeeding remains controversial due of their transfer to the~     child through lactation. The aim of the study is to determine the effect of acupuncture on~     postpartal perineal pain following episiotomy.~      Methods: The study is designed as a prospective interventional randomized parallel~     single-center study to evaluate the effects of auricular acupuncture on pain relief after~     episiotomy. The population will encompass 60 patients that have had mediolateral episiotomy~     performed during vaginal delivery, with 29 receiving acupuncture therapy and 31 not receiving~     acupuncture therapy for pain relief. NSAID analgesic therapy will be made available per~     request.~   "
2443|NCT03534856|"~     Roughly 30% of stroke survivors experience spasticity, a velocity-dependent increase in~     stretch reflexes. In this pilot study, the investigators aimed to examine the effects of~     mindfulness meditation on spasticity and quality of life in individuals after stroke.~   "
2444|NCT03534843|"~     To compare Child-Pugh and Albumin-Bilirubin scores in patients with spontaneous rupture of~     hepatocellular carcinoma~   "
2445|NCT03534830|"~     The research objective of this proposal is to investigate the clinical utility and validity~     of eLASV as a personalized marker for women's individual risk of recurrence for pelvic organ~     prolapse following advanced surgical procedures. Estimated levator ani subtended volume~     (eLASV) is a reproducible magnetic resonance image of the female pelvis that objectively~     quantifies the integrity of the pelvic floor levator ani muscles. A woman's levator ani~     muscle anatomical shape is unique to her as a result of her own individual lifetime risk for~     development of pelvic floor dysfunction. The novelty of eLASV as a measurement of muscle~     integrity, separates it methodology from the solitary of diagnosing partial trauma or defects~     as previously published within the literature. eLASV measurements have the potential to~     identify women at increased risk for surgical failure and may be used as a prognostic tool to~     aid in future counseling and stratification of patients into surgical options for treatment~     of pelvic organ prolapse.~   "
2446|NCT03534817|"~     BACKGROUND: Cardiac rehabilitation (CR) is an outpatient chronic disease management program~     delivering secondary prevention, which is proven to reduce morbidity and mortality. The~     Canadian Cardiovascular Society Access to Care working group recommends patients access CR~     preferably within 2-7 days following percutaneous intervention for myocardial infarction~     (MI), but that 30-60 days is acceptable. Despite these benchmarks, in practice patients~     access CR up to 90 days post-treatment in Canada. This is disconcerting given the detrimental~     impacts of delayed access to CR. These include ventricular remodeling (i.e., ventricular~     enlargement and reduced pump function), lower CR use, less post-CR exercise, among others.~     Accordingly, EVADE will be the first randomized controlled trial (RCT) to test the effects of~     early access CR (1-week post-discharge to first CR visit) compared to standard access CR~     (7-weeks post-discharge to first CR visit) in ameliorating these concerns.~      AIMS & HYPOTHESIS: The primary aim is to compare ventricular remodeling as defined by the~     change in end-systolic volume at 1-year in participants randomized to early versus standard~     access CR. The secondary aims are: (1) to compare post-CR exercise adherence by~     accelerometry, exercise capacity by 6-minute walk test distance, and health-related quality~     of life (HRQL) at 1-year in participants randomized to early versus standard access CR; (2)~     to compare CR program session attendance in participants randomized to early versus standard~     access CR; and (3) to assess biomarkers of ventricular remodeling in participants randomized~     to early versus standard access CR.~      The final aims are to explore more immediate health benefits associated with early versus~     standard access CR. Accordingly, at 6 months following hospital discharge the investigators~     will measure end-systolic volume, exercise adherence, exercise capacity, biomarkers of~     ventricular remodeling, and HRQL. The investigators will also explore hospitalization for any~     cause of death at 1 year in order to inform future research.~      The overall hypothesis is that early access CR will be associated with less ventricular~     remodeling, increased CR attendance and post-CR exercise adherence, increased exercise~     capacity, and greater HRQL.~      DESIGN: EVADE will be a two-centre, 2 parallel-arm, single-blinded RCT. Participants will be~     recruited through coronary care units following treatment for MI from the Royal University~     Hospital in Saskatoon, Saskatchewan and the University of Alberta Hospital in Edmonton. The~     University of Alberta Research Electronic Data Capture (REDCap) online database will~     randomize (1:1) participants (allocation concealed). A total of 60 participants will be~     enrolled: 30 participants will each be allocated to early access and standard access CR.~      IMPACT: In the first prospective multicentre trial of its kind, EVADE will test an innovative~     post-MI rehabilitation strategy that has the potential to demonstrate the superior benefits~     of early access CR for attenuating ventricular remodeling, and increasing CR attendance,~     post-CR exercise adherence, exercise capacity, and HRQL. The results from EVADE would~     encourage the Canadian CR community to consider early access CR to further enhance readily~     available and existing CR programs. The knowledge gained from EVADE will inform clinical~     decision-making practices, influence future CR guidelines and policy, and will contribute to~     the ongoing goal of improving efficiency and effectiveness of the Canadian health care~     system.~   "
2447|NCT03534804|"~     This is an open label, non-randomized phase 2 study of the combination of pembrolizumab and~     cabozantinib to assess overall response rate (ORR), progression free survival at 6 months~     (PFS6), and overall survival (OS) in patients with metastatic urothelial carcinoma (UC)~     ineligible for cisplatin.~   "
2448|NCT03534791|"~     The intervention will consist of reminders which will be send to the participants randomly~     via email, with aim to increase the frequency and amount of translated plain language~     summaries (PLS).~   "
2449|NCT03534778|"~     It is still unclear if Lymph Node Yield (LNY) and Lymph Node Ratio (LNR) may have a~     prognostic role in patients affected by carcinoma of the head and neck. Only retrospective~     studies are available. For this reason, this prospective, multi center, observational study~     should provide indications in this regard. Proper stratification by patients characteristics~     will allow to understand if LNY and LNR may enter in the future TNM staging system~   "
2450|NCT03534765|"~     1. A retrospective scoping cohort review of adult patients undergoing emergency~          laparotomy/laparoscopy for acute gastrointestinal (GI) pathology who have had a CT scan~          of the abdomen(+/- pelvis). CT measured sarcopenia would be compared with clinical~          outcomes, 30-day and 1-year mortality.~        2. A prospective observational cohort study and bio-banking exercise of routinely collected~          clinical data, in a cohort of patient undergoing emergency laparotomy/laparoscopy or~          conservative treatment for an otherwise operable pathology. An interrogation of CT~          measured sarcopenia and a validated clinical frailty score would be analysed against~          clinical outcomes, 30-day and 1-year mortality.~      The investigators aim to research the association and predictive advantage of combining~     subjectively measured frailty, objectively measured CT sarcopenia and other risk predicting~     tools used in every day surgical practice and surgical outcomes (mortality and morbidity) in~     a cohort of acute surgical patients undergoing surgery or conservative treatment.~   "
2451|NCT03534752|"~     This is a retrospective study aimed at establishing a database of the current health of adult~     patients with IEM in the French-speaking part of Switzerland. .~   "
2452|NCT03534739|"~     One in ten adults experience widespread pain. Neck pain, for example, is a prevalent~     condition with a high rate of recurrence that affects between 10.4% and 21.3% of the~     population annually.~      Massage is a common manual therapy intervention for individuals with musculoskeletal pain.~     However, the mechanisms of massage are not well established. Also, the conditioned pain~     modulation (CPM) paradigm is a dynamic quantitative sensory testing measure of a pain~     inhibitory process in which pain sensitivity is lessened in response to a remotely applied~     painful stimulus.~      This study will evaluate the association between pain inducing massage and the conditioned~     pain modulation paradigm in participants with a history of neck pain.~   "
2453|NCT03534726|"~     7 Tesla MRI is a new magnetic field strength that has become available at Penn for~     cardiovascular MRI. This new scanner has potential to improve assessment of cardiovascular~     disease due to its increased signal-to-noise ratio, higher spatial resolution, and response~     to magnetic properties of tissue at high field. The purpose of this study is to assess the~     feasibility of 7 T CMR. Secondly, we wish to investigate its use, to improve clinical and~     research MRI. Altogether, 7 T may permit better clinical diagnosis of cardiomyopathy.~   "
2454|NCT03534713|"~     The main objective of this study is to determine whether neoadjuvant chemotherapy with~     Carboplatin and paclitaxel plus standard cisplatin-based chemoradiation with extended fields~     improves overall survival rates compared to standard therapy alone in women with cervical~     cancer with paraaortic lymph node involvement.~      Women in the experimental arm will receive neoadjuvant chemotherapy with carboplatin and~     paclitaxel every 21 days during 3 cycles followed by standard therapy with extended field~     external radiation therapy and concomitant chemotherapy. Women in the control arm will~     receive standard therapy with extended field external radiation therapy and concomitant~     chemotherapy.~      310 patients will be recruited during 3 years, with 3 years of follow up period.~   "
2455|NCT03534700|"~     Chronic sacrococcygeal pilonidal disease is a common acquired condition associated with~     hirsutism that predominantly affects young male patients. Morbidity from this disease results~     in pain, embarrassment and loss of normal activities, causing absenteeism from work and~     school.~      Various surgical procedures have been described for the treatment of both primary and~     recurrent pilonidal disease counting: open excision and healing by secondary intention,~     marsupialization, excision and primary closure (midline or off-midline), excision and repair~     by flap.~      No single method has been accepted as the gold standard, and none of them cancels the risk~     of recurrence.~      The optimal therapy for pilonidal sinus disease should be simple, with good aesthetic~     outcomes and a low recurrence rate. It must allow the return to normal activities quickly.~      The parasacral perforator flap seems to answer these entire requirements. No study compares~     this flap repair with the most common procedure, which is the open excision with secondary~     healing. The aim of this study is to assess the efficacy and the security of the~     reconstruction of the natal cleft with the perforator parasacral flap versus open excision~     with secondary healing in the treatment of sacrococcygeal pilonidal sinus.~   "
2456|NCT03534687|"~     This study examines the effects of 12-weeks of aerobic exercise training on the mechanisms~     driving RAGE-mediated inflammation in type 2 diabetic humans.~   "
2457|NCT03534674|"~     This study is to assess whether a single oral loading dose of 100,000 IU vitamin D3 prior to~     allogeneic hematopoietic stem cell transplant (aHSCT) can achieve optimal 25 hydroxy-vitamin~     D3(25-OH-D3) levels (>75nmol/L) at one month post aHSCT, and maintain adequate levels for at~     least three months, compared to our standard practice of 2000 IU vitamin D3 daily. 25-OH-D3~     levels will be measured prior to vitamin D3 supplementation, and 30 as well as 100 days post~     vitamin D supplementation. We hypothesize that the intervention will prevent vitamin D~     insufficiency or deficiency in aHSCT recipients, therefore benefit aHSCT-associated~     morbidity, including osteoporosis.~   "
2458|NCT03534661|"~     The gut is able to retain some fat for many hours after a fatty meal. The gut hormone~     glucagon-like peptide-2 (GLP-2) is known to release these fat stores in the gut, but it is~     not known how GLP-2 achieves this. One possibility is that GLP-2 increases blood flow in the~     gut. NG-monomethyl-L-arginine (L-NMMA) is a substance that inhibits nitric oxide synthase (an~     enzyme that helps make nitric oxide which increases blood flow). This protocol examines~     whether blocking gut blood flow with L-NMMA is able to prevent GLP-2 from releasing gut lipid~     stores. Healthy participants will be treated with a combination of Teduglutide (a resistant~     form of GLP-2) and L-NMMA, and their respective controls. Blood lipid levels will be measured~     following treatments.~   "
2459|NCT03534648|"~     Drug drug interaction study between PF-05221304 and PF-06865571~   "
2931|NCT03528499|"~     Interventions focused on the scapula have been frequently used to treat shoulder pain.~     However, most studies do not assess the contribution of scapular movement alteration for the~     symptoms.~      Objectives: To compare the effects of two interventions for shoulder pain: Scapular Movement~     Training and General Exercises.~   "
2460|NCT03534635|"~     This is a monocentric, prospective, interventional and translational phase II study.~     Metastatic melanoma (mMEL) patients who are naive to immune therapy in the metastatic~     setting, and for whom an anti-Programmed Cell Death-1 (PD-1) therapy is needed could be~     eligible.~      The aim of the study is to identify biological markers which allow to better understand and~     predict the tumor response to pembrolizumab treatment, and thus to establish more efficient~     treatments for selected patients. Eligible patients will be registered (n=30) and will be~     treated with pembrolizumab monotherapy at 200 mg every three weeks for 2 years maximum until~     progression, unacceptable toxicity, or withdrawal of consent, whichever happens first.~     Patients may be treated for up to one year of additional treatment with pembrolizumab via the~     Second Course Phase. Patients will be followed medically and radiographically during~     pembrolizumab treatment. Patients will be followed radiographically every 9 weeks (+/- 7~     days) until progression and disease evaluation will be assessed by RECIST 1.1 criteria. After~     progression, patients will be followed every 6 months for 5 years to collect survival data.~   "
2461|NCT03534622|"~     The purpose of this study is to evaluate the steady-state intrapulmonary disposition of~     delafloxacin in healthy adult participants.~   "
2462|NCT03534609|"~     The Genius system is substantially equivalent to the Infini device (K121481). The study is a~     prospective, multi-site, non-randomized study of up to 30 treated subjects presenting for~     treatment of mild to moderate lines, wrinkles, textural concerns, and/or skin laxity of the~     neck.~   "
2463|NCT03534596|"~     A cohort study of patients operated for adhesive small bowel obstruction (SBO) during a~     five-year period~   "
2464|NCT03534583|"~     Post-traumatic stress disorder (PTSD) is the third most common mental illness with a lifetime~     prevalence rate of 9.2% in Canada. Depression and anxiety are common comorbidities making~     treatment complex. Currently available treatments for PTSD include medications and talk~     therapies. However, their best combined response rates are around 50%. Our recent pilot~     feasibility study showed potential benefits of a breathing based meditation intervention~     called Sudarshan Kriya Yoga (SKY) in PTSD, as an augmentation treatment. The investigators~     seek to now assess the safety and efficacy of SKY intervention compared to an active control,~     Health Enhancement Program (HEP) in a double blind randomized controlled trial. The~     investigators will include PTSD patients with a wide range of trauma experience including~     road traffic accidents, childhood, physical, emotional or sexual abuse, or recurrent traumas~     over the lifespan. Patients will be offered a 12-week program of either SKY or HEP~     interventions as an add-on to their existing treatment schedules. This study will examine if~     patients with PTSD experience a reduction in PTSD symptoms from baseline to 12-week~     follow-up, as measured by the PCL-5 after receiving either HEP or SKY.~   "
2465|NCT03534570|"~     To assess the need of respiratory gated radiotherapy in left sided breast cancer patients.~   "
2466|NCT03534557|"~     Comparison of FEV1/FEV6 and FEV6 as an alternative for FEV1/FVC and FCV in the detection of~     airway obstruction in a Bolivian population~   "
2467|NCT03534544|"~     The goal of this study is to learn more about patient and family preferences regarding use of~     advanced diabetes technologies. Young persons with type 1 diabetes (ages 8-25) and parents of~     young persons with type 1 diabetes will complete one study visit involving a semi-structured~     interview and surveys. The results of the study will be used to assist in the design of a new~     automated insulin delivery system.~   "
2468|NCT03534531|"~     The purpose of this study is to determine if cortisone shots in the neck are helpful in~     patients with certain MRI findings. Additionally, the investigators hope to learn if cervical~     facet joint steroid injections are beneficial in the subset of patients with MRI findings~     consistent with facet joint synovitis.~   "
2469|NCT03534518|"~     Successful ambulation at home and in the community is the main goal of gait training after~     incomplete spinal cord injury. Many different treatment approaches have been recommended to~     achieve this goal. One established intervention to achieve that in a clinical setting is body~     weight supported (BWS) treadmill training. However, recent studies have suggested that the~     most optimal gait training should be conducted overground with appropriate support conditions~     to enable a physiological gait pattern. The training has to be challenging and patients must~     participate as active as possible.~      In addition becoming a functional walker in real world involves a variety of walking skills~     like walking on uneven surfaces, walking up and down slopes, climbing stairs and avoid~     obstacles. It has been shown in humans as well as in animals that greater improvements are~     achieved in walking function if the training is task specific. Thus a constrained task like~     BWS treadmill training may not be the optimal training intervention to become a functional~     community walker.~      Even greater improvements can be expected if patients feel safe during the overground walking~     and train at their individual limits. With FLOAT there is now the possibility to conduct a~     task specific BWS overground gait training in a safe environment. The robotic device allows~     patients to perform different walking tasks like walking overground, avoiding obstacles,~     walking on uneven and sloped surfaces, climbing stairs, walking in narrow spaces. A virtual~     reality setup was integrated into the system that even can simulate specific walking tasks~     like target oriented walking or walking in crowded environment. Based on the promising~     results seen in preclinical and clinical research, the investigators assume that unrestricted~     transparent BWS overground training that allows task specific training of real world walking~     tasks will induce greater improvements than conventional BWS treadmill training.~      The investigators will compare the effect of an intensive 4 weeks unrestricted BWS overground~     gait training to 4 weeks of intensive BWS treadmill training. Not only functional outcome~     like walking speed or capacity will be assessed but also detailed kinematics that will help~     to identify the mechanisms of the underlying improvements in walking function.~   "
2470|NCT03534505|"~     Inguinal hernia is one of the most common diseases worldwide, including Thailand. Patients~     who underwent treatment of inguinal hernia (herniorrhaphy) found surgical site pain.There are~     many procedures to relieve pain after surgery. Injection of pain killer at the surgical site~     is a well-known method nowadays, especially with NSAIDs; Nowadays, Ketorolac is among the~     most-often used drug in the research. B. Ben-David's et al. published in 1995. is the study~     of the effects of the Ketorolac by comparing 60 mg of Ketorolac injected intramuscularly and~     30 mg injections at the surgical site in 32 patients who underwent herniorrhaphy. Observing~     patients after surgery, postoperative pain score at 2 and 6. After 24 hours of surgery, they~     found that the patients who were given Ketorolac 30 mg suffered less pain than the group of~     patients who had Ketorolac 60 mg with statistical significant (P<0.05). The study by Connelly~     and colleagues, published in 1997, was a randomized double-blind study which compared the~     performance of relieving pain after surgery of surgical site injection of Ketorolac 60 mg and~     intravenous injection of Ketorolac 60 mg. In studies of 30 patients with herniorrhaphy~     surgery, the results showed within 24 hours of surgery, the group of patients with surgical~     site injections suffered less pain than the group of patients with intravenous injection~     (P<0.02). Besides they discovered that the time to first analgesia in the group of patients~     with surgical site injection was longer. (P<0.03), and the amount of analgesic requirement~     that the patients needed in the first 24 hours after surgery was also less in this group.~     (P<0.0002). According to the research above surgical site injection of Ketorolac is effective~     in pain relief. Bupivacaine is the most accepted drug using local infiltratively to relieve~     the pain especially in patients with herniorrhaphy. Previous studies of Bupivacaine found~     that Bupivacaine is a very effective in pain reliever, can reduce the usage of opioids, and~     also can reduce the recovery time in hospital. Thus, our study is to demonstrate the~     effectiveness of pain relief after surgery by local infiltration of Ketorolac in a patients~     who undergo herniorrhaphy by dividing patients into two groups and comparing between~     Ketorolac and Bupivacaine injection at surgical site.~   "
2547|NCT03533491|"~     The current proposal is aimed at developing a substance use cessation app (Rewire) for high~     risk adolescents who are involved in the juvenile justice system. The Rewire app will be~     based on the primary substance use cessation components tested in our previous work with~     juvenile justice-involved adolescents and on intervention components shown to be central to~     smoking cessation.~   "
2471|NCT03534492|"~     The standard of care for muscle-invasive bladder cancer (MIBC) is radical cystectomy, which~     is rarely curative. Platinum-based neoadjuvant chemotherapy is associated with an improvement~     in Overall Survival (OS), but only a few patients can benefit from this approach. Therefore,~     new neoadjuvant treatments are required for muscle- invasive bladder cancer. In this study it~     will be explored the activity of durvalumab plus olaparib in advanced Transitional Cell~     Carcinoma of the Bladder and therefore may have beneficial outcomes in the neoadjuvant~     setting. Adverse events associated with durvalumab and olaparib is one of the potential risks~     in this study. Participation in this trial, in which 6-8 weeks of preoperative treatment will~     be administered, is not expected to result in delays of surgery for participants. It is not~     foreseen that treatment with durvalumab and olaparib has a relevant impact on operability or~     increases the risks associated with surgery~   "
2472|NCT03534479|"~     Endothelial dysfunction and insulin resistance play a key role in the onset and development~     of atherosclerosis, cardiovascular diseases, and diabetes. Data in mice models have recently~     demonstrated that circulating immunoglobulins G (IgG) could be involved in the process.~     Patients with common variable immunodeficiency (CVID), who are characterized by low~     circulating levels of IgG, might represent an ideal model to clarify the role played in vivo~     in humans by circulating IgG. Polyclonal IgG, obtained from multiple donors, given~     intravenously (IVIgG), are used to treat various immunodeficiencies and autoimmune diseases,~     including CVID. By using this disease and its treatment by IVIgG as a model, aim of the~     current study is to clarify whether IgG affect endothelial function and insulin sensitivity~     in humans in vivo and whether the action of IgG on the endothelium involves a direct~     interaction with the endothelial cells.~   "
2473|NCT03534466|"~     There have been many studies on the use of running training in older children to improve gait~     development in children with cerebral palsy. The aim of our study was to conduct early~     treadmill training in infants who were highly suspected of cerebral palsy and to follow up on~     their long-term gait development.~   "
2474|NCT03534453|"~     This is a prospective, open-label, single arm, multi-centre interventional study to assess~     the clinical efficacy and safety of olaparib maintenance monotherapy and will be conducted in~     patients with platinum sensitive relapsed (PSR) high grade epithelial ovarian, fallopian~     tube, or primary peritoneal cancer who are in response (complete response or partial~     response) to platinum-based chemotherapy~   "
2475|NCT03534440|"~     Patients scheduled for Thoracic Endovascular Aortic Repair (TEVAR) surgery will have~     transthoracic echocardiography evaluation of left ventricle diastolic function during the~     perioperative period.~   "
2476|NCT03534427|"~     The purpose of this study was to examine the impact of a 12-week jump rope exercise program~     on blood pressure, arterial stiffness, vasodilating and vasoconstricting factors,~     inflammatory markers, and body composition in prehypertensive adolescent girls. Forty~     prehypertensive adolescent girls participated in this study. The girls were randomly divided~     into the jump rope exercise intervention group (EX, n=20) and control group (CON, n=20). The~     EX group performed a jump rope training program at 40-70% of their heart rate reserve (HRR) 5~     days/week for 12 weeks (sessions 50 minutes in duration). The CON group did not participate~     in any structured or unstructured exercise protocol. Blood pressure, arterial stiffness,~     plasma nitrate/nitrite levels, endothelin-1, C-reactive protein, and body composition were~     measured before and after the 12-weeks study.~   "
2477|NCT03534414|"~     The European Association for the Study of Diabetes (EASD) guidelines have not made any~     specific recommendations regarding the Portfolio diet, a dietary pattern that includes nuts,~     viscous fibre, plant protein, and plant sterols. To update the recommendations, the Diabetes~     and Nutrition Study Group (DNSG) of the EASD commissioned a systematic review and~     meta-analysis using the Grading of Recommendations Assessment, Development, and Evaluation~     (GRADE) approach to summarize the available evidence from controlled trials of the effect of~     the Portfolio dietary pattern on LDL-cholesterol (LDL-C) and other established~     cardiometabolic risk factors.~   "
2478|NCT03534401|"~     The primary purpose of this research is to conduct a small matched cluster control trial of~     an intervention designed to address reproductive coercion and unintended pregnancy (ARCHES -~     Addressing Reproductive Coercion within Healthcare Settings) adapted to the Kenyan cultural~     and family planning healthcare context (ARCHES Kenya) so as to provide initial data regarding~     acceptability, feasibility and efficacy in this high-need LMIC context.~   "
2479|NCT03534388|"~     Feasibility study in approximately 20 subjects to investigate the rate of infection with~     subjects undergoing elective lower extremity arterial bypass graft surgery or femoral~     endarterectomy. The subjects are instructed to shower with the sodium hypochlorite body wash~     daily, or as modified by the physician, for 5 of the 7 days leading to their surgery.~   "
2480|NCT03534375|"~     Risk-taking in early adolescence have has been found to be normative and even formative as it~     might fulfill the youth's needs to experiment different sensations, make independent~     decisions and learn from their consequences. Several theoretical models have suggested that~     male and female adolescents differ in risk-taking as a product of individual/contextual~     factors and neocortical functioning; however, the neurophysiological and neuropsychological~     correlates of those differences continue to be underexplored. Informed by Evolutionary~     Neuroandrogenic Theory, the investigators examine the links between gender, risk-proneness,~     gratification delay, self-control, self-efficacy, executive functions and~     neurophysiological-neuroanatomical correlates in early adolescents (age 10-12 years).~     Participants (N=24; 50% females) will complete behavioral measurements on study constructs~     and perform neuropsychological tests using fMRI scanning (e.g., Go/NoGo continuous~     performance, stop-signal reaction time, NIH Cognition Battery, delay discounting). Female and~     male groups will be compared on all outcome measures.~   "
2500|NCT03534115|"~     Dental bleaching is a simple procedure for aesthetic restoration of vital and non-vital~     discolored teeth. Nevertheless, a number of studies conducted previously demonstrated the~     risk of tissue damage from contact of these agents with the oral mucosa along with their~     possible genotoxic potential after exposure to oral mucosa. Hence the aim of this study is to~     conduct a human clinical trial to incorporate the chemoprotectant N-acetyl cysteine (NAC) in~     the procedure of bleaching which could safely be used to eliminate the toxicity of bleaching~     materials leaving their esthetic benefits intact. 30-40 human subjects will be recruited and~     bleaching will be done at the UCLA School of Dentistry dental clinic.~   "
2481|NCT03534362|"~     Surgery on the frontal sinus is done for patients who have sinus problems that do not respond~     to medications. It involves making an opening within the right and left frontal sinus of the~     nose to help it drain. For severe frontal sinus disease, the sinus is widely opened and the~     left and right sinuses become one large sinus. This is done with sharp instruments and rigid~     endoscopes placed through the nostrils. While the sinus heals after surgery, a stent or~     steroids or both may be used to try to help make sure that the opening does not close back~     up. Two current options for this are Propel stents and steroid-soaked Nasopore. Propel stents~     are FDA-approved. Nasopore and Kenalog injection are both FDA-approved, but their use~     together is part of the study and not specifically FDA-approved. A previous study shows that~     Propel stents are useful to reduce scarring in other frontal sinus procedures. We would like~     to know whether this is true in larger frontal sinus surgery where one common cavity is made~     and whether both steroid-containing stents are the same.~   "
2482|NCT03534349|"~     The investigator investigated the effect of lower limb flexibility on functional performance~     of children with Duchenne Muscular Dystrophy.~   "
2483|NCT03534336|"~     The objective of this project is to design a Behavioral Economics Based Online Lifestyle~     Balance Program that employs behavioral economics to engage and motivate adherence to the~     Internet-based program. We compare the effects of two financial incentives on inducing weight~     loss: a direct financial incentive for weight loss and a financial incentive for learning~     health literacy.~   "
2484|NCT03534323|"~     This research study is assessing a new drug, duvelisib, in combination with a drug that is~     already FDA approved, venetoclax, as a possible treatment for participants with CLL.~   "
2485|NCT03534310|"~     Background/Objectives: Only 1% of the clinically eligible subjects receive surgical treatment~     for their obesity, thus other options should be investigated. In this study we aim to assess~     the effect of intensive-lifestyle-modification(ILM) with or without Liraglutide-3mg daily~     versus sleeve-gastrectomy(SG) on BMI at 1-year.~      Subjects/Methods: In this study performed in a University Hospital in Italy, non-diabetic~     patients eligible for bariatric-surgery are recruited from the weight loss clinic and have~     the option to choose within three possible weight-loss programs up to complete the allocation~     of 25 subjects in each arm matched by BMI and age. ILM consists in 600kcal~     very-low-calorie-diet(VLCD) for 1 month followed by 12kcal/kgbw high-protein, high-fat-diet~     for 11 months plus 30minutes brisk-walk daily and at least 3 hours aerobic-exercise weekly.~     SG patients have 1-month VLCD and free-diet thereafter. Patients are evaluated at baseline~     and at 1,3,6,9 and 12months.~   "
2486|NCT03534297|"~     This is a Phase 1b randomized, double-blinded, single-center safety and pharmacodynamics~     study of sequential cohort, dose-escalating, repeat-dosing of dapansutrile or placebo (4:1~     ratio) in subjects with stable systolic heart failure (HF) with LVEF≤40% symptomatic for NYHA~     functional classification II-III who show signs of systemic inflammation (high sensitivity~     plasma C reactive protein [hsCRP] > 2 mg/L). A total of 20 subjects will be enrolled in 2~     sequential cohorts by randomized allocation (8 active and 2 placebo within each cohort).~     Progression of dose escalation will occur following the Day 14 visit of the last subject in~     the first cohort.~      Subjects will be screened and evaluated twice for eligibility: 1) at the time of Screening~     (up to 28 days prior to enrollment); and 2) at the Baseline visit, prior to randomization.~     Following enrollment, Baseline assessments will be conducted and the first dose of~     investigational product (either dapansutrile capsules or placebo capsules) will be~     administered at the clinical site upon completion of all assessment and collection of~     baseline parameters. Subjects will then self-administer investigational product once or twice~     daily, depending on cohort, for up to fourteen (14) consecutive days beginning at the~     Baseline visit and continuing through the planned Day 14 visit. Subjects will return to the~     study clinic on Days 4, 8, 14 and 28 for follow-up visits. Additionally, subjects will be~     contacted for telephone follow-up on Day 42.~      Subjects will be screened and evaluated twice for eligibility: 1) at the time of Screening~     (up to 28 days prior to enrollment); and 2) at the Baseline visit, prior to randomization.~     Following enrollment, Baseline assessments will be conducted and the first dose of~     investigational product (either dapansutrile capsules or placebo capsules) will be~     administered at the clinical site upon completion of all assessment and collection of~     baseline parameters. Subjects will then self-administer investigational product once or twice~     daily, depending on cohort, for up to fourteen (14) consecutive days beginning at the~     Baseline visit and continuing through the planned Day 14 visit. Subjects will return to the~     study clinic on Days 4, 8, 14 and 28 for follow-up visits. Additionally, subjects will be~     contacted for telephone follow-up on Day 42.~   "
2487|NCT03534284|"~     Insomnia is a common and distressing symptom for patients on hemodialysis (HD), and there is~     evidence for a much larger impact on the health of patients. Chronic insomnia is disrupted~     sleep that occurs at least three nights per week and lasts at least three months.~      The SLEEP-HD study is a randomized open-label clinical trial to compare two types of~     treatment for insomnia in participants who have end-stage renal disease on HD, and who have~     been diagnosed with chronic insomnia. The two types of treatment involved in the study are~     Cognitive Behavioral Therapy for Insomnia (CBT-I) or treatment with a drug (trazodone vs~     placebo).~      125 participants will be enrolled who are undergoing HD in two study locations (Seattle,~     Washington and Albuquerque, New Mexico).~   "
2488|NCT03534271|"~     The primary aim of this research is to determine the accuracy of smartphone pulse oximeters~     in detecting blood oxygen saturations, episodes of desaturations, and heart rate by comparing~     results to a Masimo© hospital-grade pulse oximeter.~   "
2489|NCT03534258|"~     This study is designed as a prospective, non-randomized, observational, multicenter clinical~     trial. The primary aim of this study is to observe if the use of the rapid responds~     electroencephalography (EEG) system impacts physician decision making. Secondary aims include~     exploring the safety and performance information of the Ceribell EEG system compared to~     conventional EEG system. The study will recruit physicians (Faculty physicians and Trainees)~     at up to five institutions and examine the impact of rapid response EEG when providing care~     to patients in whom EEG recording has been ordered for clinical reasons.~   "
2490|NCT03534245|"~     Background:~      Some mosquitos carry viruses that can cause disease. Some examples are dengue and Zika. The~     mosquitos spread disease by biting people and infecting them with the virus. Children,~     elderly people, and people who are already sick are especially likely to get infected.~     Researchers want to learn more to help make new medicines to treat these viral infections.~      Objective:~      To learn more about how mosquitos infect people, and why young children are more likely to~     get sick than other people.~      Eligibility:~      Healthy children 2-9 years old who live near the study site. This is Kampong Speu District~     Referral Hospital in Chbar Mon, Cambodia.~      Design:~      At visit 1, participants will have a physical exam. A small amount of blood will be taken~     from their arm or finger. Parents will answer questions about the participant s general~     health and medical history.~      Participants will come back to the study site every wet season and every dry season for the~     next 3 years. The visits will be the same as visit 1 and take about 1 hour.~      If at any time during the study the participant gets a fever and has other symptoms that~     could be caused by these viral diseases, they should be brought to the study site. These~     symptoms might include headache, pain behind the eyes, muscle pain, or joint pain. They can~     also include a rash that lasts longer than 12 hours.~      Participation ends after the final study visit in late 2021.~   "
2510|NCT03533985|"~     This study examines the effects of 6 different music therapy interventions on outcomes for~     neonates diagnosed with Neonatal Abstinence Syndrome.~   "
2491|NCT03534232|"~     Background:~      Diabetes has been associated with many cancers including liver, pancreas, endometrial,~     colorectal, breast and bladder cancer. Excess body fat has also been linked to cancer. One~     reason for this might be resistance to insulin. Researchers want to look for links between~     insulin, diabetes, and certain cancers. They want to study data that has already been~     collected.~      Objectives:~      To study links between insulin, diabetes, and cancers. To study how the links might differ by~     gender, race, and other factors.~      Eligibility:~      People who already participated in 1 of 8 cardiovascular disease studies~      Design:~      Researchers will study data that has already been collected. There will be no active~     participants.~      Participants gave permission to share their data. The data contain no personally identifying~     information. Researchers will look at biomarkers like diet, medicines, and tobacco use. They~     will do statistical analysis of the data~   "
2492|NCT03534219|"~     This is a randomized controlled clinical trial evaluating the efficacy of the EarPopper~     device (EP) in the reduction of episodes of acute otitis media (AOM) in children with~     recurrent otitis media. The control arm will be observational. The intervention arm will have~     the EP used.~   "
2493|NCT03534206|"~     A prospective, randomized, controlled study designed to assess whether digital virtual~     reality (VR) models, created from existing CT scans and MRIs, provide surgeons with an~     improved understanding of their patients' anatomy, resulting in more efficient operations~     (robotic partial nephrectomy) and improved patient care~   "
2494|NCT03534193|"~     This is a prospective, randomized trial to evaluate the effectiveness of using educational~     modules accessed through a bedside tablet in patients newly diagnosed with Type 1 Diabetes as~     an adjunct to *standard Children's Hospital- Molly Center diabetes education in comparison to~     *standard Children's Hospital- Molly Center diabetes education. (standard diabetes education~     consists of paper based reading material and nursing education).~   "
2495|NCT03534180|"~     This phase II trial studies the side effects and best dose of venetoclax and to see how well~     it works in treating participants with mature T-cell lymphoma that has come back or does not~     respond to treatment. Venetoclax may stop the growth of cancer cells by blocking some of the~     enzymes needed for cell growth.~   "
2496|NCT03534167|"~     The aim of this study is to conduct a small randomized controlled trial (RCT) for a 10-week~     mobile phone intervention using principles of Cognitive Behavior Therapy to target general~     and minority stressors and treat anxiety and depression in young men romantically/sexually~     attracted to men.~   "
2497|NCT03534154|"~     Traumatic brain injury (TBI) occurs when the brain is physically damaged, for example after a~     car crash. It is common and survivors often have major on-going problems. It is very~     difficult to predict how patients will do after TBI. One reason for this is that clinicians~     and researchers are unable to measure all the effects of TBI. An important factor is that the~     connections between nerve cells are damaged by the impact on the brain of an injury (axonal~     injury). This damage has been difficult to measure in the past, but new ways to scan the~     brain and more sensitive ways of picking up the effects of this injury in the blood could~     change this. In other parts of medicine tests of this type have had a dramatic effect on how~     clinicians treat patients. For example, the products of heart muscle damage that have leaked~     into the blood can be used identify a heart attack and guide treatment. Clinicians need~     similar tests to be available in TBI. This should be possible as the products of axonal~     injury also leak into the blood and researchers have a sensitive way to pick this up. An~     accurate test for axonal injury would guide treatment choices and allow clinicians to predict~     how patients will recover. The investigators have brought together an international team who~     have been working on different aspects of this problem for many years. Together the~     investigators will conduct a large study to identify the best measures of axonal injury. The~     investigators will carefully test whether these measures help predict outcomes and will study~     where the blood markers come from using a safe method to measure the effects of axonal injury~     directly from the brain. The work links into some large projects that have already started~     and will use a standard way to assess patients after their injury. This is important because~     it will allow researchers to share results across studies. The investigators hope the work~     will allow us to identify a blood marker for TBI that could be widely used to quickly~     identify the presence of axonal injury. The investigators will also show what brain imaging~     measure is best at picking up axonal injury and how best to combine the measures to best~     predict how patients recover. This will allow doctors to diagnose problems after TBI more~     accurately, choose the right treatments and give patients and their families accurate advice~     about what will happen after discharge from hospital.~   "
2498|NCT03534141|"~     Acute kidney injury (AKI), or worsening kidney function, is a common complication after liver~     transplantation (20-90% in published studies). Patients who experience AKI after liver~     transplantation have higher mortality, increased graft loss, longer hospital and intensive~     care unit stays, and more progression to chronic kidney disease compared with those who do~     not. In this study, half of the participants will have their body temperature cooled to~     slightly lower than normal (mild hypothermia) for a portion of the liver transplant~     operation, while the other half will have their body temperature maintained at normal. The~     study will evaluate if mild hypothermia protects from AKI during liver transplantation.~   "
2499|NCT03534128|"~     Many patients suffer from a topographical disorientation after a traumatic brain injury.~     Virtual Reality settings allow us to develop navigational cues, in order to rehabilitate~     patients or to help them in daily life. Some visual and auditory cues have proved efficient~     in helping patients navigating in a virtual environment but when administered separately,~     they never enabled patients to obtain a similar navigation performance as healthy controls.~     Moreover, the effect of the combination between visual and auditory cues has never been~     studied before. The objective of the present study is to determine if the combination between~     visual and auditory cues improve spatial navigation and memory of patients with a traumatic~     brain injury.~      Therefore, the investigators intend to include in this prospective randomized study 45~     patients who have had a moderate or severe traumatic brain injury and 20 healthy controls.~     Participants will have to reproduce actively with a joystick three different paths including~     6 intersections that they have previously seen on a computer screen. One path will be done~     without cues, one with visual or auditory cues, and one with combined cues (visual+auditory).~     The order of the paths will be randomized. Auditory cues consist of beeping sounds indicating~     the direction at each intersection. Visual cues consist of salient landmarks (red and~     blinking) positioning at each intersection.~      The main judgment criterion will be the number of trajectory mistakes during the path~     reproduction (/6). The secondary judgment criteria will be : time of navigation, memory of~     the landmarks, the route and the survey of the virtual environment. The confirmation of the~     help given by the combined cues could further allow the patients to use them in~     rehabilitation or in real life using augmented reality.~   "
2534|NCT03533673|"~     Open-label, ascending dose trial of AAV2/8-LSPhGAA administered intravenously.~   "
2535|NCT03533660|"~     Successful treatment of alcohol associated liver disease (AALD) depends primarily on~     abstinence from alcohol. The investigators propose a randomized clinical trial of alcohol~     biosensor monitoring for patients with alcohol associated liver disease to determine if~     monitoring with feedback on alcohol use patterns reduces alcohol consumption and improves~     outcomes.~   "
2501|NCT03534102|"~     This project intends to investigate whether (1) a patient-maintained opioid diary provides an~     accurate measure of opioid consumption (morphine equivalents), (2) improved patient~     educational materials decrease narcotic consumption, and (3) using a pain management~     counselor provides additional benefits in decreasing narcotic consumption when used in~     conjunction with improved educational materials. Furthermore, the investigators would like to~     investigate the effect of the patient-maintained diaries, the improved educational materials,~     and the pain management counselor on pain levels, nausea, sleep quality, and patient~     satisfaction.~      All patients undergoing orthopedic surgery at Brigham and Women's Faulkner Hospital and~     choose to participate will be assigned to a treatment group based on which arm of the study~     is being tested at the time; (the treatment arms are sequential). Members of Group 1 (control~     group) will receive the current standardized institutional discharge care for orthopedic~     surgery and an added tracking diary. Members of Group 2 (experimental group 1) will receive~     more detailed educational materials regarding postoperative pain management — including~     instructions to how to taper their narcotic usage — as well as a tracking diary. Members of~     Group 3 (experimental group 2) will receive not only the educational materials of Group 2,~     but also weekly phone calls from a clinical patient educator to remind them of proper use of~     the diary and narcotic tapering.~   "
2502|NCT03534089|"~     A multi-center,randomized,double-blind,controlled clinical trial was used to investigate the~     effectiveness of the treatment of infant iron deficiency anemia by taking ferralia and~     different contents lactoferrin.~   "
2503|NCT03534076|"~     This 5-year prospective, observational study will: (1) determine the individual, social, and~     environmental predictors of sleep duration, quality, latency, efficiency, timing and~     regularity in African American smokers, (2) quantify the prospective relationship between~     multiple metrics of sleep with tobacco use, such that a sleep phenotype of risk for smoking~     is defined, and (3) examine the extent to which short sleep (<7 hrs) and other unhealthy~     sleep metrics, predicts lung function through smoking behaviors and inflammation, in 480~     African Americans at risk for advancing COPD (GOLD Stage 0-2 and current smoker). Study~     subjects will be recruited via Temple Health System sites. Following eligibility screening,~     initially eligible subjects will provide written study consent and complete an in-home sleep~     assessment to rule out the exclusionary moderate-severe sleep apnea and other sleep~     disorders. Consenting and eligible subjects will be entered into the study and across the~     60-month data collection period, complete 8 assessments: 4 annual clinical based assessments,~     interspersed by 4 mid-year, phone-based, self-report assessments.~   "
2504|NCT03534063|"~     This will be a randomized, open-labeled pilot pragmatic clinical trial. Patients undergoing~     arthroplasty surgery will be recruited for CYP2D6 pharmacogenetic testing from UF Health~     Orthopaedic clinic to manage post-surgical pain. Patient will be randomized to either usual~     care of genotype-guided care.~   "
2505|NCT03534050|"~     Background: Infiltrative low grade gliomas (LGGs) are the most common primary central nervous~     system malignancies excluding the highest grade glioma, glioblastoma multiforme. Craniotomy~     with maximal safe tumor resection is endeavored to achieve longer survivals in LGG patients.~     Unfortunately, due to the infiltrative nature of gliomas and the frequent tumor location in~     eloquent areas, gross total resection is usually not applicable. According to National~     Comprehensive Cancer Network 2015 guidelines, postoperative adjuvant radiation therapy (RT)~     is recommended for most adult patients with low-grade infiltrative LGGs in order to enhance~     local control and prolong progression-free survival (PFS), except those who are no older than~     40 years of age and in whom maximal safe resection is not feasible. However, brain~     irradiation-related neurocognitive function (NCF) sequelae are potentially and indeed a~     concern which should not be ignored. In terms of the time course of cranial~     irradiation-induced NCF decline, it might vary considerably according to the specific domains~     which are selected to be measured. Early neurocognitive decline principally involve~     impairments of episodic memory, which has been significantly associated with functions of the~     hippocampus. This study thus aims to investigate the impact of partial brain irradiation with~     using contemporary radiotherapeutic techniques on neurocognitive performances, intracranial~     local control, and progression-free survival in patients with intracranial high-risk grade 2~     or 3 gliomas.~      Methods: Patients with intracranial high-risk low-grade or grade 3 gliomas will be enrolled~     to this study once postoperative adjuvant RT is recommended. All eligible and recruited~     patients should receive baseline functional brain MRI examination and baseline~     neurobehavioral assessment. Subsequently, partial cranial irradiation will be initiated~     within one month approximately after enrollment. Brain RT dose will be 5000 - 6000 cGy in 25~     - 30 fraction during 5 - 7 weeks. Accordingly, a battery of neuropsychological measures,~     which includes 7 standardized neuropsychological tests (e.g., executive functions, verbal &~     non-verbal memory, working memory, and psychomotor speed), is used to evaluate~     neurobehavioral functions for our registered patients. The primary outcome measure is delayed~     recall, as determined by the change/decline in verbal memory or non-verbal memory from the~     baseline assessment to 4 months after the start of postoperative adjuvant RT.~   "
2506|NCT03534037|"~     Hyperuricemia is an additional risk factor for cardiovascular disease, associating with left~     ventricular diastolic dysfunction in individuals with metabolic syndrome. The effect of~     urate-lowering therapies on left ventricular diastolic dysfunction remains unclear. The study~     is conducted to investigate whether febuxostat or benzbromarone might improve left~     ventricular diastolic dysfunction in individuals with metabolic syndrome and hyperuricemia~   "
2507|NCT03534024|"~     Metabolic syndrome is a condition which is recognized by abdominal obesity, dyslipidemia,~     hyperglycemia, and hypertension. Curcumin has beneficial effects such as antioxidant and~     anti-inflammatory effects. nanomcielle curcumin will be used in this study because of the low~     bioavailability , fast metabolism and low absorption of curcumin powder. Therefore, this~     study is planned to determine the effects of supplementation of nanomicelle curcumin on~     glycemic control, serum lipid profile ,blood pressure and anthropometric measurements in~     patients with metabolic syndrome.~   "
2508|NCT03534011|"~     The primary aim of this study is to investigate the feasibility and complications of~     inserting a REBOA-catheter to patients suffering from non-traumatic out-of-hospital cardiac~     arrest, by anesthesiologist working in the pre-hospital setting. The study will include~     patients in the catchment population of St. Olavs University Hospital, Trondheim area,~     Norway. The REBOA technique (resuscitative balloon occlusion of the aorta) is a well-known~     treatment used on other indications, both in-hospital and pre-hospital. It has also been~     utilized in several animal studies on non-traumatic cardiac arrest and has shown to augment~     myocardial and cerebral perfusion during cardio-pulmonary resuscitation. There are no~     systematic studies on humans with REBOA in non-traumatic cardiac arrest. The study will also~     investigate the time needed to perform a REBOA procedure in cardiac arrest patients receiving~     advanced cardiac life support. This additional treatment might contribute to increase the~     survival rate of cardiac arrest patients.~   "
2509|NCT03533998|"~     The ability of genomic biomarkers to Measuring tumour aggressiveness, and facilitate the~     selection of therapies in patients who had salvage radical prostatectomy after focal therapy~     and predict the risk of biochemical recurrence BCR after focal therapy or RP.~   "
2511|NCT03533972|"~     Periodontal disease is an immune-inflammatory disease which consists of connective tissue~     breakdown, loss of attachment, and alveolar bone loss.In normal physiology, there is an~     equilibrium maintained between reactive oxygen species (ROS) activity and antioxidant defence~     capacity. when this equilibrium changes and shifts in favour of ROS, it will result in~     oxidative stress (OS). Increased levels of acute phase proteins have been associated with~     gingival inflammation and periodontitis, which reflected the locally stressed environment. it~     has been well established that in chronic inflammation sites there is over-production of ROS.~     The human body consists of an array of antioxidant defense mechanisms (non-enzymatic and~     enzymatic antioxidants) which removes harmful ROS as soon as they are formed and prevent~     their deleterious effects. Superoxide dismutase (SOD), catalase (CAT), and glutathione~     peroxidase are the enzymatic antioxidants, while the nonenzymatic antioxidants include~     vitamins E and C, and reduced glutathione. C - reactive protein (CRP) is a plasma protein~     that reflects a measure of the acute phase response to inflammation and is one of the markers~     of choice in monitoring this response. Changes in peripheral blood cellular and molecular~     components can be seen in patients with periodontitis, as periodontitis includes inflammatory~     changes of the periodontal tissues. Ashwagandha is also known as Indian ginseng and winter~     cherry. It consists of dried roots of Withania Somnifera (Family: Solanaceae).6 The Sanskrit~     words ashva meaning horse, and gandha meaning smell together form the name Ashwagandha.~     Ashwagandha possessed marked anti-inflammatory effect against denaturation of protein in~     vitro. the effect was plausibly due to the alkaloid and withanolide contents of ashwagandha.~     It is a multipurpose herb, which acts as adaptogenic, antioxidant, anticancer, anxiolytic,~     antidepressant, cardio protective, thyroid modulating, immunomodulating, antibacterial,~     anti-inflammatory, neuroprotective, cognitive enhancing and hematopoietic agent.So, this~     study is carried out to assess SOD & CRP levels with or without Ashwagandha supplementation~     as an adjunct to scaling and root planing(SRP) in chronic periodontitis(CP) patients.~   "
2512|NCT03533959|"~     The aim of this study is to evaluate the efficacy of alirocumab for in-stent~     neoatherosclerosis by using optical coherence tomography, in comparison with standard statin~     therapy.~   "
2513|NCT03533946|"~     This is a single arm, open label, phase II trial to assess efficacy of rucaparib.~   "
2514|NCT03533933|"~     There are some orthodontics treatments that perform risk movements ,and a bone dehiscence may~     be expected. In that cases mucogingival surgery , such as connective tissue grafts, is~     necessary prior to tooth movement.~      The connective tissue graft in combination with coronal advanced flap is still considered the~     gold standard , although the use of porcine collagen matrix has obtained promising results~     for treatment of Miller class I and II recession defects.~      Most of the studies report clinical results after a connective tissue graft and there is no~     evidence about the type of attachment obtained after the graft is performed, a few articles~     have shown histological results. But, as a rule , a histological study is only performed~     under exceptional circumstances such as a dental fracture, untreatable decay, tooth~     extraction for orthodontic reasons, or other reasons.~      Most of the techniques results in the formation of a long junctional epithelium and~     connective tissue attachment with fibers parallel to the root surface. Animals studies have~     shown a shorter epithelium and a larger new cementum formation after the use of the collagen~     matrix.~   "
2515|NCT03533920|"~     Pivotal Clinical Trial to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable~     Hepatocellular Carcinoma~   "
2516|NCT03533907|"~     The investigators analyzed a group of infertile women treated with Ulipristal Acetate (UA)~     for uterine fibroids at the Humanitas Fertility Center. All the patients' data were extracted~     from the Fertility Center external-audit-anonymized electronic research query system.~   "
2517|NCT03533894|"~     colic capsule usings with patients without possible colic endoscopy~   "
2518|NCT03533881|"~     The present study aims to evaluate the efficacy of Arom Digest Slim in facilitating weight~     reduction along with a series of minimal nutritional interventions.~   "
2519|NCT03533868|"~     The UNAIDS 90-90-90 goals represents an ambitious strategy to end the acquired~     immunodeficiency syndrome (AIDS) epidemic by 2020 [UNAIDS, 2015]. While viral load (VL)~     quantification is the gold standard of HIV treatment monitoring, it is only routinely~     available and employed in resource-rich countries. The use of an affordable, reliable,~     point-of-care (POC) VL assay has been considered a game-changer, where increased access,~     minimal lab worker training, and same day results could be addressed in a single solution. To~     date, POC VL assays have been evaluated by their manufacturers with reference panels of~     samples with some in-country laboratory evaluations. While these are appropriate and critical~     first steps, it is also important to evaluate the impact of this new technology against the~     standard of care (SOC) method of VL monitoring in an actual resource-limited setting.~      Nigeria has the second highest burden of HIV in the world, with an estimated 3.2 million~     infected and serves as a relevant setting for testing feasibility and efficacy of POC VL~     monitoring [UNAIDS, 2016]. In order to present the case for implementing the use of POC VL~     testing across Nigeria, data on the acceptability, feasibility and efficacy of using POC~     testing for VL monitoring are needed. To address this need, the investigators have designed a~     randomized controlled trial comparing POC VL to monitoring to the SOC, which follows the~     Nigerian National Guidelines, to provide operational evidence for implementation of POC VL~     testing in Nigeria. This trial is aimed at testing the hypothesis that using POC versus SOC~     VL monitoring in HIV-infected patients newly initiating ART will improve overall ART~     outcomes, increase ART adherence and program retention rates, and result in faster switches~     to second-line treatment of patients failing first-line ART.~   "
2520|NCT03533855|"~     The sequence of 3D CP-IRM, used in current practice in the protocols of bilio-pancreatic~     imaging, can be thus optimized to reduce acquisition time, thus the artefacts of movement, in~     particular in 3T. It remains however to estimate if the quality of obtained image is~     equivalent at least to that of the conventional sequence, without apnea, 3D CP-IRM.~      To summarize, the investigators suggest comparing the classic sequence (Fast Relaxation Fast~     Spin Echo (FRFSE) 3D) already existing with the same sequence to which will be added a~     technique of CS allowing its acquisition at shortened time(weather), with respiratory trigger~     on one hand and in apnea on the other hand. For the patient, this study will have for~     consequence only the addition of 2 sequence MRI, one of the 2 minutes 30 seconds (with~     respiratory trigger) and other one of the 20 seconds (in apnea).~   "
2536|NCT03533647|"~     The study aims to observe the relationship between the changes of ocular structure parameters~     and pathological changes among children and adolescents with high myopia. Environmental~     factors and family history will also be collected to explore their impacts on high myopia~     progression.~   "
2578|NCT03533088|"~     Rotator cuff muscles are originates from the scapula and they are primarly responsible for~     the dynamic stabilization of glenohumeral joint. Optimal scapulo-humeral rythm is needed for~     their optimal functioning. However; after surgeries of rotator cuff tears little is know~     about the scapulo-humeral rythm is restored or not. The aim of the study is to investigate~     changes in scapular kinematics after rotator cuff repair surgery.~   "
2521|NCT03533842|"~     The investigators conceived a computerized interactive tool for Emergency Triage, based on a~     patient's symptoms, medical history and background. Using this tool, the patient (alone or~     helped by a nurse / supporting person) presenting to an ophthalmologic ER, should be able to~     detect and prioritize his most urgent symptoms (A,B), in opposition to less urgent (C) or non~     urgent symptoms (D). To test the validity of this tool, each patient presenting at the~     Rothschild Foundation ER (Paris, France) with an ophthalmological problem should be included~     and sorted by the algorithm before the medical consultation. Neither the patient nor the~     practitioner are aware of the scoring (A,B,C,D) defined by the algorithm. The practitioner~     should then give his own emergency scoring (A,B,C,D) after patient examination. A total of~     1000 patients is expected.~   "
2522|NCT03533829|"~     This is a randomized controlled open-label trial. During the study, adolescents scheduled to~     receive at least one IM vaccine will receive either Buzzy®, Music, or Buzzy® and Music~     intervention(s) in addition to standard care to evaluate the feasibility and acceptability of~     these interventions prior to being used in a larger study to assess the effectiveness of the~     interventions in preventing post-vaccination presyncope and syncope. Feasibility will be~     assessed according to study staff ability to successfully administer the protocol specified~     clinic-based interventions and per both study staff and healthcare provider responses to~     written feasibility assessments. Acceptability will be assessed according to the~     participant's self-report. In addition, baseline needle phobia and anxiety, post-vaccination~     pain and presyncope symptoms, and pre- and post- vaccination state anxiety will be assessed~     per participant written self-report to standardized survey questions.~   "
2523|NCT03533816|"~     Gamma delta T-cells are part of the innate immune system with the ability to recognize~     malignant cells and kill them. This study uses gamma delta T-cells to maximize the anti-tumor~     response and minimize graft versus host disease (GVHD) in leukemic and myelodysplastic~     patients who have had a partially mismatched bone marrow transplant (haploidentical).~   "
2524|NCT03533803|"~     IVF/ICSI patients who had difficult mock embryo transfer on the day of ovum pick up. Will be~     randomly assigned into two groups; group A will receive 100mg indomethacin rectal suppository~     1-2 hours before ET and group B will not receive indomethacin~   "
2525|NCT03533790|"~     This study aimed to investigate the efficacy and safety of ruxolitinib together with~     liposomal doxorubicin, etoposide and methylprednisolone (DEP-Ru) as a salvage therapy for~     refractory/relapsed hemophagocytic lymphohistiocytosis.~   "
2526|NCT03533777|"~     The purpose of this study is to compare success rates of antegrade and retrograde intravenous~     (IV) catheters in their ability to aspirate 20 milliliter blood sample within a 2 minute time~     frame, 3 hours after initial insertion. Antegrade IV catheters are placed identically to~     conventional IV catheters, with the end of the catheter pointed toward the direction of blood~     flow to the heart. Retrograde catheters are placed backwards with the end of the catheter~     pointed away from the direction of venous blood flow. The hypothesis is that retrograde IVs~     will have a significantly higher success rate of blood draw at the 3 hour time mark without~     use of a proximal tourniquet.~   "
2527|NCT03533764|"~     The investigators will test if their intervention, Asthma Self-Management for Adolescents~     (ASMA), an 8-week, high school-based intervention for teenagers, improves asthma in rural~     high school students with uncontrolled asthma when delivered by CHWs. The investigators will~     also test the cost-effectiveness of ASMA, and examine the barriers and facilitators of ASMA's~     widespread implementation.~   "
2528|NCT03533751|"~     This study is designed to evaluate the efficacy, safety, and pharmacokinetic (PK) profiles of~     multiple doses of ANB020 in subjects with atopic dermatitis (AD).~   "
2529|NCT03533738|"~     The study hypothesizes that vegetable and protein consumed before a carbohydrate will reduce~     the glucose response. The vegetables and protein consumed before carbohydrate have different~     effects on insulin and satiety responses.~   "
2530|NCT03533725|"~     This study will compare data associated with breastfeeding experiences and~     outcomes--specifically, breastfeeding continuation after initiation, exclusivity for 6 months~     of an infant's life, and breastfeeding duration--among 120 subjects recruited late in~     pregnancy and provided peer counseling and education services incorporating mobile health~     (mHealth) tools during a period of at least 6 months post-delivery with the data collected~     from a control group of approximately 120 mothers that did not receive the study~     intervention.~   "
2531|NCT03533712|"~     The 2016 WHO antenatal care guidelines stated that pregnant women in undernourished~     populations should receive fortified balanced energy-protein (BEP) supplements to reduce the~     risk of stillbirth and small-for-gestational-age birth. However, acceptable supplements and~     delivery channels must be determined for different contexts.~      The present proposal therefore will 1) perform a formative study to identify the most~     suitable (acceptability and utilization) BEP supplement for pregnant women in rural Burkina~     Faso (phase 1 and 2) and 2) evaluate the efficacy of this supplement to improve birth weight,~     fetal and infant growth (phase 3). The nutritional composition of the BEP supplement was~     established during an expert convening at the BMGF in September 2016. Private sector partners~     will prepare the supplements in the selected forms with the recommended nutrient composition.~   "
2532|NCT03533699|"~     The present study is conducted to compare the effect of Oral Propranolol and Oxytocin, versus~     Oxytocin only on induction of labor in term pregnancy.~   "
2533|NCT03533686|"~     Standard treatment for single-sided deafness and conductive hearing loss includes bone~     anchored implants. Such devices have been well established as safe and effective, however~     require surgical procedure and lifelong use of an implant. Similar results can be achieved~     using the same auditory processors from the implantable system coupled to a headband with the~     processor worn at the impaired mastoid. While non-invasive, the use of a headband is~     complicated by discomfort with longterm use and stigma associated with the visibility of the~     device. The Adhear bone conduction system (MEDEL Corp) uses a novel longwear adhesive to~     allow for non-invasive use of the audio processor without the discomfort or stigma associated~     with traditional headband use. Bone conduction hearing systems have the ability to provide~     immediate and sustainable benefit in these specified hearing loss populations, but have seen~     varying levels of adoption and acceptance because of the limiting factors surrounding the~     need for surgery or use of a large and uncomfortable headband. This study will investigate~     the hearing outcomes and adoption and acceptance of the Adhear bone conduction system.~   "
2537|NCT03533634|"~     The purpose of this study was to evaluate the functional outcome in patients with a midshaft~     clavicle fracture treated with to different techniques. the first one was placing a 3.5mm~     reconstruction plate in the superior side of the clavicle and the second one placing the same~     3.5mm reconstruction plate in the anteroinferior side of the clavicle. the patients had the~     same rehabilitation program and evaluated with functional scores at 30, 60, 90 and 365 days~     after surgery. biomechanical studies have demonstrated more stable construct using an~     anteroinferior plate in clavicle fractures and we were trying to find out if it has a~     clinical relevance in patients with midshaft clavicle fractures.~   "
2538|NCT03533621|"~     Recent studies have shown that the bacteria in the gut (gut microbiome) can affect adiposity~     levels and inflammation. In animal studies, changing these bacteria has been linked with~     decreased fat mass and inflammation as well as improved metabolism. Probiotics can be a safe~     method of altering the gut microbiome in humans and have shown promising results in adults~     with regards to changing adiposity and inflammatory markers. However, it may also be~     important to provide the right dietary milieu (i.e. high fruit and vegetable/low saturated~     fat diet) in order to see the benefits of probiotics on these physiologic markers. At this~     time, no one has offered probiotics in the context of the right dietary milieu and tested it~     in children. This pilot proposal is innovative because it will be the first to test how well~     probiotics work in the context of a diet high in fruits and vegetables to change the gut~     microbiome, decrease fat mass, and improve inflammatory markers in overweight/obese children.~     This protocol will allow one to better understand the effect of probiotics on these~     physiologic functions and determine acceptability and feasibility of taking daily probiotics.~   "
2539|NCT03533608|"~     Prolonged Exposure therapy (PE) is a first-line treatment for posttraumatic stress disorder;~     however few VA patients receive this treatment. One of the barriers to PE receipt is that~     this treatment is only available in an individual (one-on-one) format, whereas many VA mental~     health clinics provide the majority of their psychotherapy services in group format. In~     particular, PTSD residential rehabilitation programs (RRTPs) offer most programming in group~     format. Thus, the current study was designed to pilot test a group format of PE in RRTPs.~   "
2540|NCT03533595|"~     STRATAFIX Symmetric PDS Plus sutures will reduce the time required for fascial closure~     following spinal surgery. A pilot study will aide in the design of a larger randomized~     controlled trial to compare suture closure time of the STRATAFIX Symmetric PDS Plus sutures~     versus traditional Vicryl sutures.~   "
2541|NCT03533582|"~     This partially randomized phase II/III trial studies how well cisplatin and combination~     chemotherapy works in treating children and young adults with hepatoblastoma or liver cancer~     after surgery. Drugs used in chemotherapy, such as cisplatin, doxorubicin, fluorouracil,~     vincristine sulfate, carboplatin, etoposide, irinotecan, sorafenib, gemcitabine and~     oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Giving combination~     chemotherapy after surgery may kill more tumor cells.~   "
2542|NCT03533569|"~     Osteoarthritis (OA) is a condition affecting the whole joint and is a major cause of pain and~     disability worldwide. Although OA is very common, the initial steps which lead to the~     development of pain and tissue damage are not fully understood. In this study participants~     will be investigated for markers in the blood, joint and urine in people who have a diagnosis~     of osteoarthritis or inflammatory arthritis and are receiving a steroid injection for their~     condition. Markers will be evaluated in participants with osteoarthritis compared with other~     types of arthritis, including rheumatoid arthritis and spondyloarthritis.~   "
2543|NCT03533556|"~     L-theanine and caffeine are two natural constituents of tea. Both of these compounds are~     among the U.S. Food and Drug Administration's list of Generally Recognized as Safe (GRAS)~     substances. Results of several clinical trials the PI and his team has conducted are~     consistent with results of many others to indicate that oral intake of each of 2.5 mg/kg body~     weight of L-theanine and 2.0 mg/kg body weight of caffeine is associated with improved~     attention in adults. Furthermore, there is evidence to suggest that, when taken in~     combination, L-theanine and caffeine seem to have additive effects in improving attention in~     adults. However, the specific actions of these substances have not been examined in children~     and adolescents with attention deficit hyperactivity disorder (ADHD), who are characterized~     by impaired attention, hyperkinesia and impulsivity.~      Therefore, the investigators plan to study the functional activity of brains (both at rest~     and when performing standard tasks designed to measure attention) in children diagnosed with~     ADHD using functional magnetic resonance imaging, after they consume either 2.5 mg/kg of~     L-theanine, 2.0 mg/kg of caffeine and their combination as compared to a placebo (water).~     Based on our previous findings, the investigators expect to observe improvements (speed of~     responding and accuracy) in standard tests of attention with intake of L-theanine, caffeine~     and their combination as compared to the placebo. The investigators also expect to observe~     decreased functional activity in brain regions that typically show increased activity during~     mind wandering with intake of L-theanine, caffeine and their combination.~   "
2544|NCT03533543|"~     To characterize and estimate the incidence rate of new-onset atrial fibrillation (NOAF) in~     patients with acute myocardial infarction (MI). To explore the prognostic implications of~     NOAF in patients with MI. To further validate the impact of NOAF subtypes, such as time-point~     of NOAF occurrence, NOAF burden (transient, paroxysmal, and persistent), and frequency (1~     episode vs >1 episodes) on clinical outcomes.~   "
2545|NCT03533530|"~     This study evaluates to what extend electrical source imaging (ESI) provides nonredundant~     information in the evaluation of epilepsy surgery candidates. Epilepsy surgery normally~     requires an extensive multimodal workup to identify the epileptic focus. This workup includes~     Magnetic Resonance Imaging (MRI), electroencephalography (EEG) without source imaging, video~     monitoring and when needed Positron Emission Tomography (PET), Magnetoencephalography (MEG),~     Single Photon Emission Computed Tomography (SPECT) and invasive EEG recordings using~     implanted electrodes. ESI estimates the location of the epileptic source with a high~     sensitivity and specificity using inverse source estimation methods on non-invasive EEG~     recordings. This study aims to investigate the clinical utility of ESI using low-density (LD,~     25 channels) and high-density (HD, 256 channels) EEG. Clinical utility is defined in this~     study as the proportion of patients in whom the patient management plan was changed, based on~     the results of ESI. Should ESI be added to the routine work-up of epilepsy surgery~     candidates.~   "
2548|NCT03533478|"~     Macular edema is the main cause of low vision in diabetics. They continue looking for new~     treatment alternatives. The nutritional supplement Alzer, is a powerful antioxidant that~     together with Diamel, a supplement that has shown efficacy in metabolic control, could be a~     therapeutic option. Objective: To evaluate the therapeutic efficacy of the Alzer Diamel~     combination in mild and moderate macular edema. Material and method: A randomized~     double-blind phase II clinical trial versus placebo will be conducted in 64 patients, who~     will be randomly assigned to two groups, one will receive Alzer + Diamel and another will~     receive placebo from Alzer and Diamel. All patients will undergo clinical, biochemical and~     ophthalmological evaluation during the study.~   "
2549|NCT03533465|"~     The purpose of this study is to learn more about the causes of Complicated Grief (CG) in~     those who experience the loss of a loved one. This study aims at learning more about the~     sleep patterns and emotions in participants with CG as compared to those who have lost a~     loved one but do not have CG.~      This study will consist of two aims:~      Aim 1: Approximately 10 complicated grief (CG) patients and 10 controls (without a current~     psychiatric diagnosis) will complete a 3-day home polysomnography (PSG) sleep assessment in~     addition to several self-report sleep and psychiatric measures.~      Aim 2: Approximately 10 CG patients (subsample from Aim 1) will complete 16 weekly sessions~     of complicated grief therapy (CGT) in addition to completion of repeated PSG assessments and~     self-report sleep and psychiatric measures.~   "
2550|NCT03533452|"~     Arthroscopic rotator cuff surgery of the shoulder is performed under general anesthesia. Pain~     control for after the surgery can be achieved purely with intravenous and oral pain~     medication or in combination with freezing of the nerves. Nerve freezing (nerve block) placed~     before surgery has the potential to substantially reduce the amount of inhaled anesthetic~     given to the patient during surgery. This can benefit the patient by minimizing the opioid~     usage after surgery and also reduce cost to the system in terms of duration of hospital stay.~     The purpose of the study is to investigate whether the inclusion of a nerve block to the~     general anesthetic for rotator cuff repair surgery will also reduce the amount of inhaled~     anesthetic and thereby lowering the environmental footprint from the anesthetic.~      The investigators of the proposed study plan to quantify the amount of inhaled anesthetic~     used for each case and will compare how the consumption is affected by whether the nerve~     block is applied before or after surgery. Patients will have a nerve block catheter~     (interscalene catheter) placed under ultrasound-guidance prior to the induction of general~     anesthetic by an experienced regional anesthesiologist. The nerve block catheter will be~     bolused with a solution to which the anesthesiologist is blinded which will either be local~     anesthetic or normal saline (sham). The general anesthetic will be conducted according to a~     the protocol with the aim of maintaining a standard anesthetic depth monitored by patient~     state index (PSI). Measurements of the MAC-Value (minimum alveolar concentration) of inhaled~     anesthetic will be recorded every five minutes and the total amount of volatile anesthetic~     (in ml and ml/kg) will be noted down by a blinded observer. At the end of the case the~     anesthesiologist blinded to the solution will inject another solution (now a saline (sham) or~     local anesthetic before the patient is woken up.~   "
2551|NCT03533439|"~     Gastroschisis is one of the most common neonatal surgical conditions, and is increasing in~     incidence. Postnatal bowel ischemia leading to necrosis, bowel loss and short-bowel syndrome,~     occurs in a few instances, with significant impact. Intestinal gangrene occurs in up to 37%.~     The cause of the gangrene can be multifactorial. Contributing factors can be volvulus; venous~     engorgement with ensuing arterial compromise; constriction of the gut mesentery at the~     defect; and contribution of the hydrostatic effect of the column of bowel within a silo.~      Theoretically, the increased hydrostatic pressure incurred by the bowel in a preformed silo,~     may decrease blood flow to the apex of the bowel and contribute to ischemia. However, this~     does not seem to be the norm, as most cases do well in the silo. Cases of intestinal~     ischaemia within the silo have been described in patients. Any objective measure of bowel~     perfusion and therefore viability which can aid clinical assessment and management may~     benefit patient outcome.~      Near-infrared spectroscopy (NIRS) is used to noninvasively measure and monitor changes in the~     approximate regional haemoglobin oxygen saturation (SO2) in the blood. Measurement of oxygen~     saturation using NIRS is already in clinical application in other neonatal and paediatric~     medical and surgical diseases. NIRS has been recommended as a good trend indicator of changes~     in neonatal tissues oxygenation. NIRS-measured duration of cerebral oxygen desaturation is an~     accurate predictor of postoperative neurological injury in children undergoing cardiac~     surgery.~      The investigators propose to use NIRS to measure SO2 in the intestinal bed in patients with~     gastroschisis and to ascertain if there is any clinical advantage to routine monitoring in~     these patients.~      The aim of the study will be to:~        1. Measure Gastrointestinal SO2 (GSO2) of the bowel within the silo of gastroschisis~          patients~        2. Identify the clinical progress of patients with gastroschisis in the postnatal period~        3. Identify any association of the measured GSO2 with the clinical outcome and any~          gastrointestinal complications~   "
2552|NCT03533426|"~     The aim of this prospective, single blinded, comparative pilot study is to evaluate U/S~     guided serratus anterior plane catheter block (SAPB) versus patient-controlled analgesia~     (PCA) on the emergence of post - thoracotomy pain syndrome (PTPS). The investigator's assumed~     hypothesis is that; SAPB is an effective thoracic analgesic technique that may reduce the~     development of PTPS.~   "
2553|NCT03533413|"~     In the current study, extra-guidance other than conventional fluoroscopy - will be integrated~     to improve the success of the transforaminal approach to the thoracic dorsal root ganglia~     (DRG). The investigators hypothesize that joining CT scan with fluoroscopy to guide RF~     ablation through the transforaminal route may enhance its efficacy and safety in relieving~     the intractable pain associated with chest malignancies. The current study aimed to compare~     the results of thermal radiofrequency ablation (TRFA) of the thoracic DRG under combined CT~     and fluoroscopy guidance with the classic standard fluoroscopy technique.~   "
2554|NCT03533400|"~     The Effectiveness of the Jamboxx Respiratory Therapy Device in Treatment of Patients with~     Decreased Respiratory Function is a proposal for investigation of the application of gaming~     to improving respiratory health. The Jamboxx device combines gaming with traditional~     incentive spirometry to provide users with a fun experience to keep them engaged in their~     respiratory therapy routine. The device allows users to play a series of mini-games that walk~     them through their routines. The Jamboxx also records airflow and lung parameters with an~     external mouthpiece attachment to provide users with real time feedback, and helps to assess~     increases or decreases in relative lung function over time. The Jamboxx has the potential to~     significantly impact the field of respiratory therapy by being one of the first gaming~     devices for patient therapy, and the first respiratory therapy gaming device that is~     accessible to users with limited mobility. Jamboxx provides a fun and engaging, low cost~     alternative to the traditional therapy techniques used and aims to improve patient~     compliance.~   "
2555|NCT03533387|"~     To compare the bioavailability and pharmacokinetic profiles of two different formulations~     MN-166 50mg, extended release (ER) tablets with MN-166 10mg capsules in a single-dose regimen~     in healthy volunteers~   "
2579|NCT03533075|"~     The overall objective is to determine the acceptability and feasibility of the Teachable~     Moment Brief Intervention (TMBI) + follow-up consultation for Veterans treated on an~     inpatient psychiatry unit following a suicide attempt. The study will also determine whether~     there is a signal of effectiveness supporting the TMBI in improving the recovery trajectory~     of Veterans following discharge to the community.~   "
2954|NCT03528200|"~     This is a prospective pilot study evaluating the efficacy of DynaCT in direct comparison to~     conventional catheter angiography in demonstrating the anatomic details of the vessels~     supplying brain lesions. Forty patients will be recruited for this pilot study.~   "
2556|NCT03533374|"~     Electroencephalography (EEG) records electric activity of the brain using electrodes placed~     on the scalp. EEG is an important tool in the diagnostic work-up of patients with epilepsy.~     Specific types of sharp EEG discharges (epileptiform discharges) are associated with patients~     with epilepsy.~      The International Federation of Clinical Neurophysiology (IFCN) has recently published a set~     of six operational criteria for identifying epileptiform discharges. At least four criteria~     need to be present in order to classify a discharge as epileptiform. These criteria are~     largely based on expert opinion and have not been validated yet. It is not clear what the~     sensitivity and specificity of these criteria are, and which combination of these criteria~     are optimal. Each criterion is based on visual assessment. However, it is not known what the~     inter-rater agreement of these criteria are.~      EEG is traditionally inspected in sensor space, i.e. in the recording channels. Advances in~     signal analysis made possible reconstructing the electric currents in the regions of the~     brain generating them, and displaying the signals in the source space, instead of the sensor~     space.~      The objectives of this study are: to determine the inter-rater agreement of the IFCN criteria~     by visual analysis in sensor space, to determine the combination of criteria with the best~     accuracy (sensitivity and specificity) and assess the accuracy of evaluating the discharges~     in source space.~      The raters will analyze EEG recordings from 100 patients, from two groups: consecutive~     patients with epilepsy and consecutive patients with non-epileptic paroxysmal episodes. EEG~     was recorded during long-term video-EEG monitoring. As reference standard, the investigators~     used the evaluation of the patients´ habitual clinical episode.~   "
2557|NCT03533361|"~     This is an Expanded Access Program to make lenvatinib available to participants with~     radioiodine-refractory differentiated thyroid cancer in Brazil. Participants who have no~     other treatment options available, and who, in the opinion and clinical judgment of the~     treating physician, would benefit from treatment with lenvatinib will be enrolled. This is a~     multicenter, open-label program consisting of 2 phases: a 28-day pretreatment phase~     (including screening) and a treatment phase. Treatment will be provided as long as there is a~     clinical benefit based on tumor assessments performed according to the center's standard of~     care and the judgment of the participant's treating physician.~   "
2558|NCT03533348|"~     The study aims to determine whether there is a need for preparative fasting prior to~     contrast-enhanced computed tomography (CT).~   "
2559|NCT03533335|"~     The primary objective of this 6 month study is to compare the effectiveness of oral health~     promotion interventions on both clinical oral health, and oral opportunistic respiratory~     pathogens in institutionalized elders. Secondary objectives are to investigate changes in~     oral health-related quality of life, incidence of adverse side effects, pneumonia, as well as~     subject acceptability.~      Elders residing in nursing homes in Hong Kong will be recruited into the clinical trial.~     Patients will be randomly allocated into one of the following groups: 0.2% chlorhexidine~     spray, 0.1% pH-balanced chlorine dioxide spray, or sterile water spray (placebo control),~     once daily. Dental plaque, gingival bleeding, oral opportunistic respiratory pathogens, oral~     health-related quality of life (OHRQoL), and pneumonia incidence will be assessed at~     baseline, 3 months and 6 months. Subject acceptability of the interventions will be assessed~     at the end of the clinical trial.~   "
2560|NCT03533322|"~     Gall bladder status among children with chronic haemolytic anemia attending to Assuit~     University Children Hospital.~      Hemolysis is defined as the premature destruction of red blood cells (RBCs) (a shortened RBC~     life span). Anemia results when the rate of destruction exceeds the capacity of the marrow to~     produce RBCs. Normal RBC survival time is 110-120 days (half-life: 55-60 days), and thus,~     approximately 0.85% of the most senescent RBCs are removed and replaced each day.~      Patients with chronic haemolytic anemia are subjected to many complications of chronic~     haemolytic anemia e.g anemic heart failure, complications of blood transfusion as hepatitis~     and AIDS, hypersplenism, haemosiderosis ,among them there is incidence of gallbladder stone~     formation.~      This work aims to a) to determine the prevalence of gall bladder diseases among patient with~     chronic haemolytic anemia.~      b) to determine the risk factors of gall bladder diseases among patients with chronic~     haemolytic anemia.~   "
2561|NCT03533309|"~     In patient with horizontal deficiency in alveolar ridge of the anterior maxilla, Dose~     computer Guided stent enhance the accuracy and clinical outcome vs conventional ridge~     splitting surgery????~   "
2562|NCT03533296|"~     The investigators assess the changes in respiratory compliance according to different levels~     of positive end expiratory pressure (PEEP) in children under general anesthesia. In addition,~     the investigators evaluate the intratidal compliance-volume profile at each PEEP level and~     determine the optimal PEEP level during anesthesia.~   "
2563|NCT03533283|"~     This is an open-label, single arm, multicenter, dose finding, Phase Ib study in order to~     assess the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) for this~     combination treatment and to evaluate the general safety, tolerability, pharmacokinetic (PK),~     pharmacodynamic, and preliminary anti-tumor activity of this combination treatment in adult~     patients.~   "
2564|NCT03533270|"~     The management of posterior urethral disruption secondary to blunt pelvic injury remains~     controversial. While many groups have recommended early realignment of urethral distraction~     injuries, Classic reports advocate a suprapubic cystostomy at the time of injury with~     delayed, perineal approach urethral re- construction 4 to 6 months after injury . Timing of~     the intervention typically is classified as :~        1. -Immediate treatment: when it takes place less than 48 hours after injury,~        2. -Delayed primary treatment : after 2 to 14 days, and~        3. -Deferred treatment : 3 months or more after injury.~   "
2565|NCT03533257|"~     The proposed study will be a 24-week, randomized, double-blind, multi-site,~     placebo-controlled study in volunteers with late mild cognitive impairment (MCI) or early~     dementia due to Alzheimer's disease (AD).~   "
2580|NCT03533062|"~     The investigators attend to conduct a prospective randomized study to assess safety and~     efficacy of trigonal-involved vs. trigonal-sparing botox injection technique, quality of life~     measurement and post-injection anticholinergics use efficacy.~      Assessing safety by identification of side effects like constipation, urine retention....etc.~      efficacy is measured using Over Active Bladder Symptoms Score(OABSS) and urodynamics measures~     after 6 months follow up.~   "
5991|NCT03488446|"~     This study proposes to establish a CT radiomics-based prediction model for identifying~     metastasis of each station lymph nodes in gastric cancer.~   "
2566|NCT03533244|"~     A pterygium is a wing-shaped, benign tissue growth which forms on the surface of the~     conjunctiva and grows towards the cornea. It can eventually lead to vision impairment. The~     precise cause of pterygium formation is unknown but new blood vessel growth and fibroblastic~     structures are characteristics of the disease. AG-86893 is an eye drop being developed to~     treat hyperemia (redness) and growth of the pterygium.~      Hypothesis~        1. AG-86893 dosed three times daily for 28 consecutive days has an acceptable safety~          profile as measured by the incidence and severity of adverse events (AEs) compared with~          vehicle~        2. At least 1 concentration of AG-86893 is effective, as measured by the mean change from~          baseline in conjunctival hyperemia (redness), compared with vehicle~   "
2567|NCT03533231|"~     This Study Was Made to Evaluate the Antibacterial Effect of Different Antibacterial~     Combinations on Revascularization Process in Permanent Anterior Immature Teeth. Immature~     Necrotic Permanent Maxillary Incisors (n = 40) of Patients 8-18 Years Old Were Divided Into 4~     Equal Groups (Each n = 10) According to the Intracanal Medicament: Group 1 Was Treated With~     Triple Antibiotic Paste (TAP), Group 2 Was Treated With Ciprofloxacin + Propolis Paste (CP),~     Group 3 Was Treated With Ciprofloxacin + Metronidazole Paste (CM), Group 4 Was Treated With~     Propolis + Metronidazole Paste (PM). Cases Were Followed at Regular Intervals up to 18 Months~     Clinically and Radiographically.~   "
2568|NCT03533218|"~     First seconds after birth, new born baby go through physiologic changes to successfully~     adjust to the external environment specially establishment of independent respiration.~     Majority of the organ systems adaptation in newborns occur gradually, but radical and rapid~     cardiopulmonary adaptation must occur for neonates to survive. It is during this period that~     approximately 10% neonates require some level of support in the form of resuscitation.~      A knowledgeable, quick and skillful response by all caregivers is crucial for extra uterine~     survival. Tracheal intubation is performed frequently in the Neonatal Intensive Care Units~     (NICU) and delivery rooms. Neonatal intubation is a critical and time-sensitive procedure,~     and failure deprives the sickest newborns of oxygen.~      Current methods to detect a misplaced esophageal ETT in newborns are suboptimal. Physical~     examination findings are often unreliable, exhaled carbon-dioxide testing is often~     unavailable outside of resource-rich facilities and can lead to false positive results ,while~     chest radiographs are not only time consuming ,labor intensive but also expose vulnerable~     newborn babies to significant radiation However portable ultrasound machines are relatively~     available even in small centers mostly being used in the maternity units, being an~     indispensable tool for managing obstetrics, gynecology and trauma cases.~      POCUS methods of assessing ETT position offer an alternative that is time saving, cheap and~     safe, thereby of critical importance in the neonatal time-is-brain scenario.~      Our project aims to demonstrate that POCUS can effectively and accurately detect esophageal~     intubations, and in shorter period of time than current standard-of-care methods that are~     colorimetric end- tidal carbon-dioxide (CO2) detector and chest x-ray.~   "
2569|NCT03533205|"~     Intraoperative hypotension occurs often and is associated with adverse patient outcomes such~     as stroke, myocardial infarction and renal injury.~      The aim of this study was to test the accuracy of a physiology-based machine-learning~     algorithm using continuous non-invasive measurement of the blood pressure waveform with the~     Nexfin® finger cuff during surgery.~   "
2570|NCT03533192|"~     The purpose of this school-level randomized intervention trial is to evaluate the It's Your~     Game…Keep It Real program, an evidence-based teen pregnancy, HIV, and STI prevention program,~     among 2,000 students from 20 middle schools in 10 participating school districts in Harris~     County and surrounding areas. An audio computer-assisted self interview (A-CASI) assessment~     was used to assess demographic characteristics, psychosocial factors, sexual behaviors, and~     program exposure at three data collection points. Data was collected at baseline~     (preintervention), 6 months post intervention, and 12 months post intervention.~   "
2571|NCT03533179|"~     This trial investigates effects of a glucagon bolus injection on heart rate, blood pressure~     and cardiac output during beta-blocker-induced cardiodepression. Furthermore, the effects of~     two different doses of intravenous glucagon on hemodynamic parameters are explored.~   "
2572|NCT03533166|"~     Aim: To evaluate the efficacy of a 0.03% chlorhexidine (CHX) and 0.05% cetyl pyridinium~     chloride (CPC) mouth rinse, as an adjunct to professionally and patient-administered~     mechanical plaque removal, in the treatment of peri-implant mucositis.~      Material and Methods: Patients displaying peri-implant mucositis in, at least, one implant~     were included in this randomized, double-blinded, clinical trial. Subjects received a~     conventional professional prophylaxis (at baseline and 6-month visits) and were instructed to~     regular oral hygiene practices and to rinse, twice daily, during one year, with a 0.03% CHX~     and 0.05% CPC mouth rinse, or a placebo. Clinical, radiographic and microbiological data were~     recorded at baseline, 6 and 12 months. Disease resolution was defined as the absence of~     bleeding on probing (BOP). Repeated measures ANOVA, Student-t and chi square tests were used.~   "
2573|NCT03533153|"~     The investigators scheduled to assess the value of intravenous injection of WJ-MSC in~     patients with ST-segment elevation myocardial infarction (STEMI).~   "
2574|NCT03533140|"~     The current study will evaluate the potential of stimulating the R.auricularis of the vagus~     nerve located at the Fossa triangularis to ameliorate or suppress AF in the study Population!~   "
2575|NCT03533127|"~     This is a Randomized, Double-blind, Multicenter Phase III Study Comparing Efficacy and Safety~     of LY01008 (Recombinant Humanized Anti-Human Vascular Endothelial Growth Factor Monoclonal~     Antibody Injection) and Bevacizumab Combined with Paclitaxel and Carboplatin for Treatment of~     Naïve Subjects with Metastatic or Recurrent Nonsquamous Non-small Cell Lung Cancer~   "
2576|NCT03533114|"~     This is a study of the efficacy and safety of JZP-258, an oxybate mixed-salts oral solution~     being developed as a low sodium alternative product for Xyrem.~   "
2577|NCT03533101|"~     Tocilizumab will be administered prior to transplantation in order to prevent the onset of~     cytokine release syndrome and its complications associated to peripheral blood haploidentical~     hematopoietic stem cell transplantation with post-transplant cyclophosphamide~   "
2640|NCT03532282|"~     This project aims to compare the effectiveness and implementation potential of two primary~     care friendly approaches to delivering an effective non-pharmacological intervention -~     cognitive behavioral therapy - for insomnia to middle aged and older adults.~   "
2581|NCT03533049|"~     This innovative research will address a gap in the literature involving the evaluation of the~     impact of an individualized family-centered mHealth application to enhance daily~     post-discharge communication following pediatric transplant. This proposal lays the~     foundation for future research with myFAMI (self-management intervention) at multiple~     pediatric transplant centers and builds the science from which to consider post discharge~     monitoring and decrease cost of care in other pediatric chronic illness populations.~   "
2582|NCT03533036|"~     Virtual reality (VR) has been used in health care settings to decrease anxiety and pain. This~     project is a feasibility study to evaluate whether virtual reality can be used in the setting~     of a first trimester pregnancy termination by D&C and whether the use of virtual reality (VR)~     headsets can help decrease anxiety for patients during this procedure.~   "
2583|NCT03533023|"~     This is the first study of its kind to assess and test an intervention to improve biological~     rhythms and general health of shift workers, specifically first responders with San Diego~     Fire and Rescue. In a randomized control trial, investigators intend to measure the health~     impact of Time Restricted Feeding in emergency responders who work a 24-hour shift schedule.~   "
2584|NCT03533010|"~     There is an association between adolescent idiopathic scoliosis (AIS) and low bone mass which~     has been reported to be a significant prognostic factor for curve progression. Given that~     dietary calcium (Ca) intake and serum Vit-D levels were also low in AIS, we therefore propose~     a randomized double-blinded placebo-controlled trial to evaluate if daily [500mg Ca + 800 IU~     Vit-D] can improve bone health and prevent curve progression in AIS. Immature AIS girls with~     Cobb angle 10-20 degrees will be randomized either to the Treatment or Placebo group with~     3-year of treatment. The main outcome measures for evaluation for those who have completed~     the 3-year treatment and have reached skeletal maturity at the end of 3-year treatment~     include: (1) percentage of patients with increase in Cobb angle≥6 degrees and (2) percentage~     of patients who require bracing. Bone measurements using advanced image acquisition~     technology(HR-pQCT) to assess bone health will also be evaluated.~   "
2585|NCT03532997|"~     The investigators aim to introduce patients with advanced cancer to supportive care~     resources, including specialty palliative care, through a novel app called ELOS (stands for~     extra layer of support) in a prospective cohort study. The investigators will compare~     participant acceptance of this new electronic tool to industry standards and follow ultimate~     referrals to outpatient palliative care compared to historical, matched controls.~   "
2586|NCT03532984|"~     Background: Dynamic balance keeps the vertical projection of the center of mass within the~     base of support while the center of mass moves. The age-related decrease in dynamic balance~     is a risk factor for falls. Dynamic balance tests are used to predict the risks for falls and~     eventual falls but the psychometric properties of most tests assessing dynamic balance are~     unsatisfactory and comprise no actual loss of balance while walking. Objectives: Using beam~     walking distance as a measure of dynamic balance, we will determine the psychometric~     properties, lifespan and patient reference values, the relationship with selected 'dynamic~     balance tests', and the accuracy of beam walking distance to predict falls. Methods: This~     cross-sectional observational study will examine healthy adults in 7 decades (n=432) at 4~     centers. Center 5 will examine patients (n=100) diagnosed with Parkinson's disease, multiple~     sclerosis, stroke, and balance disorders. At Test 1, all participants will be measured for~     demographics, medical history, grip and leg strength, short physical performance battery,~     static balance on a force platform, and dynamic balance using beam walking (4m-long, 4, 8,~     and 12 cm wide) under single (beam walking only) and dual task conditions (beam walking while~     concurrently performing an arithmetic task). In addition, cognitive function (global~     cognition, attention, executive function, processing speed, memory) will be assessed.~     Patients and healthy participants age 50+ will be additionally measured for fear of falling,~     history of falls, miniBESTest, functional reach on a force platform, timed up and go, and~     reactive balance. At Test 2, 7-10 days after Test 1, healthy adults young and age 50+ (n=40)~     will be re-tested for reliability of beam walking performance. All participants age 50+ will~     be re-called to report fear of falling and fall history 6 and 12 months after Test 1.~     Conclusion: The investigators expect to find that beam walking performance vis-à-vis the~     traditionally used balance outcomes predicts more accurately fall risks and falls.~   "
2587|NCT03532971|"~     This research study is evaluating the reactivation of BK virus in patients who have undergone~     allogeneic hematopoietic-cell transplantation.~   "
2588|NCT03532958|"~     This study is a randomized, double-blind, placebo-controlled, multi-center, dose-ranging~     study to characterize the efficacy and safety of BNZ-1 administered by slow IV push weekly~     for 3 months to adults diagnosed with moderate to severe alopecia areata, defined as having a~     >50% loss of terminal hair on the scalp. The study has three periods:~        -  30-Day Screening Period~        -  3-Month Treatment Period~        -  3-Month Follow-up Period The study will be conducted at approximately 15-20 clinical~          sites in the United States.~   "
2589|NCT03532945|"~     This is a long-term follow-up study for more than 3 years to evaluate the efficacy and safety~     of bioactive glass-ceramic intervertebral spacer (Novomax) in posterior lumbar interbody~     fusion.~   "
2590|NCT03532932|"~     The purpose of this study is to characterize the treatment patterns associated with biologics~     agents use or non-biological therapy in participants with moderate to severe Ulcerative~     Colitis (UC) and Crohn's Disease (CD).~   "
2591|NCT03532919|"~     Patients with acute hip fractures are old and vulnerable. With a majoriry classified as being~     ASA 3 or more. Frequently they receive spinal anesthesia perioperatively inducing~     hypotension. Even a short hypotensive period may induce postop cardiac T roponinT leakage as~     well as renal failure noted by Changes in Serum Creatinin or Cýstatin C This will be~     investigated and correlated to intraoperative hypotension as step one. Preliminary this will~     be followed by an intervention with vasopressor treatment perioperatively to preserve an~     adequte MABP~   "
2592|NCT03532906|"~     The objective of the study is to hopefully understand the most beneficial way to control pain~     after removing the gallbladder by keyhole surgery (laparoscopic cholecystectomy).~      The investigators will investigate two groups of patients undergoing laparoscopic~     cholecystectomy.~      One group will receive the injection of local anaesthetic into the abdominal wall (TAP block)~     and into the wounds; the second group will have local anaesthetic into the wounds only.~      In order to have meaningful results, we anticipate a large number of participants would be~     required. Therefore we would test first whether it is technically possible to set up the~     study itself.~      The investigators will be looking at parameters (willingness of patients to be recruited,~     willingness of clinicians to recruit participants, number of eligible patients, follow-up~     rates, adherence/compliance rates, number of participants needed for an adequate sample size)~     that will allow to understand if such a larger trial is technically possible to set up.~   "
2973|NCT03527953|"~     The aim of this study is to evaluate the clinical performance of three different bulk-fill~     restorative resin materials; a bulk fill resin composite, a flowable bulk fill resin~     composite and a fiber-reinforced resin in Class II restorations over a period of 24 months.~   "
2593|NCT03532893|"~     This is a multi-center, prospective, cohort study. A total of 10,000 people aged 40～75~     without lung disease will be recruited and followed for 3 years. By measure the rate of~     decline in forced expiratory volume at one second（FEV1） and baseline inflammatory biomarkers~     in exhaled breath condensate and peripheral blood, we aim to explore the predictive model for~     chronic obstructive pulmonary disease（COPD） in China.~   "
2594|NCT03532880|"~     The purpose of this study is to test the safety of a new medication, Olaparib, combined with~     radiation therapy for participants with small cell lung cancer.~   "
2595|NCT03532867|"~     Study the change of retrofoveolar choroidal thickness measured by optical coherence~     tomography during aerobic exercise inducing an increase in systolic blood pressure in healthy~     subjects.Ten healthy participants will perform an exercise (riding a bicycle ergometer) and~     will be examined with EDI-OCT. Each participant will be scanned before exercise, during the~     exercise and afterwards at 0 and 5 min. Each OCT measurement will be coupled to the arterial~     blood pressure evaluation.~   "
2596|NCT03532854|"~     The purpose of this study is to evaluate the drug-drug interaction between LGEV1801 and~     LGEV1802 in healthy male volunteers.~   "
2597|NCT03532841|"~     The study objective is to evaluate the effectiveness of oral tramadol 50 mg in reducing pain~     during the colposcopy-directed cervical biopsy.half of the patients will receive oral~     tramadol tablets and the other half will receive a placebo.~   "
2598|NCT03532828|"~     The role of head posture has been demonstrated in patient with dentofacial deformities.~     However, the relationship between body posture and jaw disorders is unclear. Moreover,~     patients with obstructive sleep apnea have the same anatomical abnormalities than patients~     with dentofacial deformities. The aim of this study is to evaluate, firstly, nocturnal~     sleeping disorders among patients with jaw disorders. Secondly, the investigators aim to~     evaluate the interaction between body posture, breathing and dentofacial deformities.~      A polygraphy will be performed on patient with dentofacial deformities before and after~     correcting jaw surgery. A postural evaluation will be done using EOS imaging system and a~     force plate~   "
2599|NCT03532815|"~     Cardiovascular disease (CVD) remains the major cause of mortality globally. Applying a~     comprehensive interventional program based on the individual's risk may reduce the incidence~     and complications of CVD; thus, helping to decrease the burden on the healthcare system. This~     study compared the effects of a 3-month intervention involving lifestyle modification and~     physical activity with standard care in women ≥30 years having a moderate-to-high risk of~     CVD, with respect to improving physical activity and cardiovascular disease risk factors at~     the National Guard Residential City in Jeddah, Saudi Arabia, in 2015. The effects of this~     community-based lifestyle program were assessed through a randomized controlled trial. Women~     in the intervention group (n=31) received health education, exercise training, and diet~     counselling as individuals and in groups according to the participant's risk. Women in the~     control group (n=28) received one health education session at the screening site. The~     Framingham risk score (FRS) was calculated at baseline and at 3 months for both groups. The~     mean participant age was 42±8 years.~   "
2600|NCT03532802|"~     Hypertrophic obstructive cardiomyopathy (HOCM) patients often develop disabling symptoms of~     heart failure. Current treatment strategies are predicated on the empirical use of~     long-standing drugs, such as beta-adrenergics, although with little evidence supporting their~     clinical beneﬁt in this disease. Metoprolol is currently the most widely used beta-blocker in~     symptomatic HOCM patients, but a randomized, placebo-controlled trial, that looks at the~     effect in HOCM patients has never been conducted. No studies of HOCM combine invasive~     pressure measurement with exercise and echocardiography. All previous studies, both invasive~     and echocardiographic, have been conducted during rest, and not during exercise. Symptoms of~     HOCM patients are function-related, and exercise testing is essential to assess the condition~     and the effect of drugs.~   "
2601|NCT03532789|"~     Overactive bladder is a clinical syndrome characterized by frequency, with or without urge~     incontinence, urgency, and nocturia, which affect patients' sleeping quality and~     rehabilitation program progressing. Current treatments include behavioral therapy (eg, life~     style adjustment, bladder training, pelvic floor muscle therapy) and medication.~     Antimuscarinic agents is the most common medications prescribed for OAB, but patients often~     have side effects like dry mouth and constipation. And there were plenty of herbal medicine~     which are beneficial to urine frequency and voiding dysfunction in ancient Chinese medicine~     books and records. In human trial, 62 Subjects diagnosed as overactive bladder will be~     enrolled and treated with Cinnamon patch. After treatment we will estimate the efficacy and~     record adverse events to conduct statistically analysis.~   "
2602|NCT03532776|"~     A clinical endpoint bioequivalence (BE) study for a Podofilox Gel 0.5% formulation for the~     treatment of external anogenital warts in comparison to Condylox® Gel 0.5% that follows the~     study design and recommendations according to Office of Generic Drugs (OGD) of U.S. Food and~     Drug Administration (FDA) Draft Guidance for Podofilox recommendations~   "
2603|NCT03532763|"~     The objective of this study is to address the anti-inflammatory effect of tocotrienol~     supplementation in subjects with moderately elevated inflammation.~      It is hypothesized that 6 months supplementation of tocotrienols will reduce inflammatory~     markers of subjects.~   "
2604|NCT03532750|"~     The primary purpose of this study is to evaluate the safety and efficacy of partial splenic~     artery embolization in the treatment of symptomatic portal vein hypertension. A secondary aim~     is to evaluate the relative efficacy of two separate splenic artery embolization techniques,~     coiling versus particle embolization of the spleen. These two methods will be compared to~     standard medical management which consist of pain management and fluid draining.~   "
2641|NCT03532269|"~     The Nightly medical application prototype is a potential, non-invasive class I medical~     device. The application has the potential to combine both diagnostic and therapeutic~     procedures for sleep. At home, Nightly measures the user's motion during sleep and then~     records the sleep pattern from the received data. The obtained data are then used for the~     diagnosis of sleep disorders (REM and NREM sleep). Using acoustic and visual stimulation, the~     application has the capability to support the natural process of falling asleep, provide a~     better night's sleep by minimizing sleep deprivation and nightmares, while awakening the user~     at the appropriate moment (during light sleep).~   "
2974|NCT03527940|"~     To analyze the relationship between the clinical data and the outcomes of STEMI patients.~   "
2605|NCT03532737|"~     Background: Locally advanced head and neck cancer (HNC) is a challenge as, in spite of~     initial good control with chemoradiation, the majority of patients fails systemically. In the~     last 2 years, immune check points inhibitors (mainly Programmed Death (PD)-1 inhibitors) were~     approved for metastatic/recurrent HNC. The favorable toxicity profile and durable responses~     was the main benefit of these drugs along the scope of cancers they were approved for.~      Aim of the study and methods: This will be a phase II non-randomized trial to define safety~     and efficacy of combining the PD-1 inhibitor pembrolizumab given concomitantly with the usual~     standard of care chemoradiation/bioradiation for locally advanced non-nasopharyngeal HNC.~     Primary end point will be assessment of toxicity and tolerability while the secondary end~     points will be response rates (RR) and progression free survival (PFS)~   "
2606|NCT03532724|"~     ORION is a retrospective, observational, one center study to evaluate the incidence of~     complications (both thromboembolic and bleedings) in a cohort of patients receiving Vitamin K~     antagonists (VKA) under a self-management program, since 2002 at the Hospital de la Santa~     Creu i Sant Pau in Barcelona (Spain)~   "
2607|NCT03532711|"~     Chemoresistance remains an obstacle in treating people with metastatic colorectal cancer~     (mCRC). Studying samples of blood and tumor tissue in the laboratory from patients with mCRC~     receiving chemotherapy may help doctors understand the effect of chemotherapy on biomarkers.~     It may also help doctors predict how patients will respond to treatment. In this study, we~     aimed to evaluate biomarkers in chemotherapy regimens for first-line chemotherapy for mCRC.~   "
2608|NCT03532698|"~     The third generation epidermal growth gactor receptor-tyrosine Kinase Inhibitor（EGFR-TKI）~     osimertinib has obvious curative effect for EGFR sensitive mutation and T790M mutation(PMID~     27959700), but acquired drug resistance will occur. Previous studies show that apoptosis~     escape can lead to EGFR-TKI resistance.Osimertinib resistant cells show abnormal activation~     of PI3K/AKT/BIM activation(PMID 28765329). The classical drug aspirin can effectively~     decrease AKT phosphorylation and activate of BIM(PMID 28881293).So Investigators speculate~     that aspirin may decrease the PI3K/AKT/BIM signaling pathways, then promote osimertinib~     resistant cells apoptosis. The current study aims to evaluate the combination of aspirin and~     osimertinib in patients with EGFR/T790M mutations.~   "
2609|NCT03532685|"~     In the study of a population of severe asthmatics, not controlled despite the treatment~     conducted, it was possible to evidence 5 phenotypic groups of patients. According to the~     refractoriness of the response to treatment, severe asthma may be phenotype in some distinct~     groups.Other prospective study found a large proportion of severe asthmatics with persistent~     airway obstruction, despite optimized treatment and systematic follow-up. Small airway~     involvement and remodelling, characterized by bronchial muscle thickening, appear to be the~     main culprits for asthma severity and persistent obstruction in this population.A point of~     interest in the severe asthmatics cohort was the vast majority were female and there were a~     considerable number of obese. Recent reviews show that the more consistent division of~     phenotypes in patients with severe asthma is still based on 3 previously described criteria~     (presence of atopy, eosinophilia and age of onset of asthma) and a more recent criterion for~     the presence of multi-comorbidities. Heterogeneity is the rule, the presumption of a natural~     evolution of gravity is not confirmed and the overlap of clusters is frequent. The stability~     and natural history of the phenotypes is poorly understood, postulating that the inflammatory~     activation of the severe asma is multifactorial and may resemble that described in the~     oncology literature.To date, there are no markers that allow prediction of lung evolution of~     most patients with severe asthma, and which patients are at greater risk of developing~     persistent or accelerated loss airflow or lung function, factors determining the severity of~     asthma. It is also unclear whether and how much phenotype-based treatment impact on disease~     control and prognosis. Future studies will be instrumental in defining how and why. These~     phenotypes are evolving, leading to the disabling characteristics of severe asthma and what~     may be the more effective therapeutic approaches for these patients. Since the initiated~     research group from 2006 has an extensive clinical, functional, inflammatory, tomographic and~     morphological evaluation of a cohort of patients with severe asthma, the ideal scenario~     exists to advance the understanding and investigation of the evolution of this rare disease~     through standardized follow-up.~   "
2610|NCT03532672|"~     The main objective of the study is to evaluate the acute effects of fasting over inflammatory~     responses.~   "
2611|NCT03532659|"~     This study evaluates the effects of physical exercise through active videogame in the~     microcirculation, macrocirculation, cardiorespiratory function and physical fitness in~     overweight adolescents. For that, they will be randomized into two groups, one being a~     control group and the other intervention group. The randomization will be made by school. The~     intervention group will perform the physical exercise through the active video game, three~     times a week, for 50 minutes, during 8 weeks. Reassessments will be performed before and~     after the intervention to evaluate the outcome variables.~   "
2612|NCT03532646|"~     Endoscopic complications such as gastro-esophageal reflux disease, ulcera, gastritis, bile~     reflux, anastomotic stricture and so on are described after gastric bypass surgery. The~     incidence of these complications after RYGB versus MGB/OAGB are getting observed.~   "
2613|NCT03532633|"~     Concentrations of micronutrients (especially purine and pyrimidine) in cord blood, blood of~     mothers and infants and human milk is studied~   "
2614|NCT03532620|"~     The primary purpose of this trial is to test the hypothesis that Pitavastatin treatment~     compared to Atorvastatin, in patients with dyslipidemia, prediabetes and hypertension, will~     have less adverse effect on Hemoglobin A1C (HbA1C), which represents long-term glucose~     metabolism.~   "
2615|NCT03532607|"~     The purpose of this pilot study is to examine the impact of music meditation therapy session~     on patients with chronic pain who are receiving Botox injections at a pain management center.~   "
2616|NCT03532594|"~     The PRODOSE trial is investigating a bespoke pharmacokinetic algorithm that calculates a~     tailored dose of protamine, required after cardiopulmonary bypass to reverse the action of~     heparin, based on individual patients and their actual bypass time.~      The PRODOSE trial aims to demonstrate that the algorithm can be used to define a protamine~     dose that will more reliably return coagulation parameters to pre-heparin levels as well as~     decreasing the risk of post-operative bleeding and transfusion.~      The trial aims to recruit 200 patients who will be randomised to either a bespoke or standard~     dose of protamine. The randomisation ratio will be 1:1 in the first instance but the trial~     uses an adaptive design and an interim analysis will be conducted after 100 patients have~     been randomised. The randomisation ratio could then be updated after the interim analysis to~     favour a superior arm whilst preserving statistical power levels.~   "
2617|NCT03532581|"~     This phase I trial studies how well indocyanine green lymphangiography works in identifying~     thoracic duct during neck surgery. Diagnostic procedures, such as near infrared fluorescence~     imaging with indocyanine green may help recognize and prevent injury to thoracic duct during~     neck surgery.~   "
2618|NCT03532568|"~     Studying whether Klotho and FGF23 have a role in UP and whether their expression change by~     BB-UVB with the improvement of pruritus.~   "
2619|NCT03532555|"~     Multiple factors contribute to growth failure in infants with BPD, including poor nutrient~     stores, inadequate intake, increased losses, and increased needs. Furthermore, compared to~     infants without BPD, those with BPD have increased resting metabolic rates and energy~     expenditure. Growth deficits manifest as lower weight, length, and head circumference, as~     well as changes in body composition. These deficits precede the development of BPD and~     persist post-discharge. While similar rates of growth are observed in very low birth weight~     infants with and without BPD once receiving equal calories, catch up growth does not occur in~     the BPD group. Thus, early growth deficits remained uncompensated.~      After iron, zinc is the most metabolically active trace element in the human body. It has a~     critical role in growth, through its actions on growth hormone, IGF-1, IGFBP-3, and bone~     metabolism. Prematurity is a risk factor for zinc deficiency, as 60% of zinc accretion occurs~     in the third trimester. Impaired intake and absorption or excess excretion can further~     increase this risk. Finally, periods of rapid growth, as seen in preterm infants, increase~     the need for zinc.~      Biochemically, zinc deficiency is defined by a serum zinc level less than 55mcg/dl. However,~     while zinc depletion is associated with deficiency, the opposite may not be true. For~     example, in starving patients, clinical symptoms of zinc deficiency occur during re-feeding,~     suggesting overall requirements are related to needs, regardless of overall zinc status. This~     may be the case in preterm infants, who may have a subclinical deficiency despite serum zinc~     level. Thus, zinc deficiency should be considered in infants with poor growth despite~     receiving adequate protein and calories.~      The objective of this study is to determine whether enteral zinc supplementation leads to~     improved growth in infants at risk for bronchopulmonary dysplasia (BPD). The investigator's~     hypothesis is that enteral zinc supplementation in very preterm infants at high risk for BPD~     will significantly improve growth compared to standard of care.~   "
2620|NCT03532542|"~     The main objective of this study is to evaluate the safety and tolerability of long-term~     treatment with 30 mg/kg of casimersen or golodirsen in patients with Duchenne muscular~     dystrophy (DMD).~   "
2621|NCT03532529|"~     Purpose of this study is to assess whether measurements obtained through speckle tracking (LV~     longitudinal and circumferential strain, RV longitudinal strain) can give additional~     information in identifying patients who develop adverse outcomes 30 days post successfully~     weaning from VA ECMO (liberation not for palliation). It is a prospective observational~     non-blinded pilot study.~      In order to achieve this purpose, speckle tracking analysis will be performed on the recorded~     images of the transoesophageal echocardiogram performed during the last VA ECMO weaning study~     of patients defined ready for VA ECMO liberation. VA ECMO liberation will be based according~     to LVOT VTI increase and clinical judgment during patients' VA ECMO weaning study. It will be~     assessed whether the population experiencing the outcomes of interest (death within 30 days~     from VA ECMO liberation, hospital admission for a new episode of cardiogenic shock or heart~     failure within 30 days from VA ECMO liberation, need for new mechanical circulatory support~     within 30 days from VA ECMO liberation) and the population not experiencing these outcomes~     have different values of strain (LV longitudinal and circumferential and RV longitudinal~     strain) during the weaning study.~   "
2622|NCT03532516|"~     This Compassionate Use Program (CUP) is setup to provide study patients with continuous~     access to Brivaracetam (BRV) for the time period between closures of the long-term follow up~     studies N01125, N01199, N01372, N01379, and N01315 and when BRV is commercially available.~   "
2623|NCT03532503|"~     One of the methods used to induce second trimester pregnancy termination is the placement of~     a transcervical Foley catheter. The aim of this randomized controlled study was to assess in~     pregnant women with an unfavourable cervix, whether there is a difference in efficacy between~     the two most commonly used insufflation volumes of Foley catheter (30mL and 50mL).~   "
2624|NCT03532490|"~     There are currently no treatments to specifically target asthma in obese adults. This pilot~     study is being conducted to investigate how effective roflumilast is in treating asthma in~     participants that have a higher BMI. Roflumilast can induce weight loss, which may lead to~     improved asthma control.~      The primary objective of TRIM is to perform a pilot placebo-controlled trial of roflumilast~     for the treatment of poorly controlled obese asthmatics.~   "
2625|NCT03532477|"~     Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the~     pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the~     pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery.~     Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological~     availability of medication. In this study the pharmacokinetic effects of bariatric surgery on~     venlafaxine are investigated.~   "
2626|NCT03532464|"~     Chlamydia trachomatis is the most commonly reported bacterial sexually transmitted infection~     (STI), especially among young women. Up to 75% of C. trachomatis infected women are~     asymptomatic. If untreated, C. trachomatis infection can cause sequelae such as pelvic~     inflammatory disease, ectopic pregnancy and tubal factor infertility. C. trachomatis can also~     cause anorectal infections, which are typically asymptomatic. Among women with urogenital~     chlamydial infection, around 36-91% also had concurrent anorectal chlamydial. Notably, there~     was no association with anal intercourse in the studies that reported it. However, guidelines~     do not recommend routine anorectal testing, but restricted testing in people who are in~     high-risk groups, report anal sexual behavior, or have anal symptoms, i.e., on selective~     indications. This is in contrast to urogenital testing, which is a routine procedure in STI~     care services.~      The anal transmission of C. trachomatis in women may occur by autoinoculation from the vagina~     due to the close proximity of the vagina and the anus. C. trachomatis could lead to a~     persistent infection in the lower gastrointestinal tract, suggesting the potential role of~     autoinoculation of cervical chlamydial infection from the rectal site. Such (repeat)~     urogenital infections could lead to reproductive tract morbidity. Recommended treatments for~     C. trachomatis infections are a single 1g dose of azithromycin or 100mg of doxycycline 2~     times a day for 7 days. Although these two regimens are equivalent for urogenital infection,~     no study has compared the effectiveness of these two treatments on anorectal infection. If~     rectal C. trachomatis is a hidden reservoir influencing transmission rates, and considering~     the potential complications of cervical infections, providing further evidence of the need~     for effective rectal treatments among women is highly relevant.~   "
2627|NCT03532451|"~     Patients with muscle-invasive bladder cancer (MIBC) who can not receive cisplatin therapy~     will receive nivolumab or nivolumab/lirilumab before a planned surgical procedure called a~     radical cystectomy (RC) to remove the bladder.~      Nivolumab works by attaching to and blocking a molecule called Programmed Death-1 (PD-1).~     Lirilumab attaches to and blocks a group of molecules called Killer Cell Immunoglobulin-Like~     Receptor (KIR). PD-1 and KIR are proteins present mainly on immune system cells, and each~     controls part of the immune system by shutting it down. It is hoped that by binding to and~     inactivating these proteins, these drugs can enhance the body's ability to detect, attack and~     destroy cancer cells.~      The purpose of this research study is to see whether nivolumab alone or combination of~     nivolumab and lirilumab given before surgery is effective in treating people who have bladder~     cancer, and to examine the side effects, good and bad, associated with nivolumab and~     lirilumab.~   "
2628|NCT03532438|"~     The purpose of the study is to identify the genetic closeness of NTM derived from patients~     living together and from their surrounding environment and to trace the temporal relationship~     between them.~   "
2975|NCT03527927|"~     To establish the feasibility of stopping inhaled steroids and switching or maintaining dual~     bronchodilation in one visit - in the real world, for people with COPD.~   "
2629|NCT03532425|"~     Atripla (ATP: FTC/TDF/EFV) was the first single pill treatment for HIV and was the most~     prescribed first-line treatment from approximately 2008 to 2013 for people infected with HIV.~     However, ATP has not been recommended as a preferred treatment for HIV since 2015, due to~     there now being single pill treatments that work better. There are a lot of people who are~     still taking ATP and it is working for them. However, it has the potential to cause serious~     side effects (chronic kidney disease and fractures and serious neurological effects). These~     side effects are caused by components in ATP (namely the TDF and EFV parts). Also, the~     efavirenz (EFV) component is not compatible for treatment of Hepatitis C (HCV) - which is~     often also seen in people who have HIV. For these reasons, there is a need to find a better~     alternative treatment for these people currently being treated with ATP.~      B/F/TAF (bictegravir/FTC/TAF) is an investigational single pill drug treatment drug that~     contains neither TDF nor EFV. This study is looking at whether changing people to this new~     drug treatment will continue to suppress their HIV and have fewer side effects.~   "
2630|NCT03532412|"~     Central sleep apnoea (CSA) is common in patients with chronic systolic heart failure (HFrEF).~     Various trials have shown a prevalence of 21 - 37% in this group of people. Up to 66% of~     patients with CSA and HFrEF present with periodic breathing (PB), which is considered being a~     marker of HF severity and poor prognosis. Brack et al. summarized data from cohorts,~     longitudinal studies and retrospective analyses showing an independently increased risk of~     death in HF patients with PB (HR 2.1-5.7 in five of seven studies). Furthermore, PB in HF~     patients is known to reduce quality of life and exercise performance and to increase~     sympathetic nerve activity as well as the probability of malignant cardiac arrhythmias.~      The pathogenesis of PB is characterized by an instability of ventilatory drive. The level of~     carbon dioxide (CO2) in blood and cerebrospinal fluid correlates linearly with minute~     ventilation. A high level of CO2 increases ventilation while hypocapnia dampens it. This~     control theory is based on the loop gain (LG), which represents the sensitivity and~     reactivity of the ventilatory system and comprises three components: The plant gain defines~     the capacity of the system to change PaCO2 in response to a change in ventilation (metabolic~     response). It is influenced by the lung volume as well as the anatomy of the thorax and the~     upper airways. The feedback gain is defined by the chemoreceptor responsiveness in reaction~     to blood gas changes. The controller gain is represented by the respiratory control center in~     the brain stem and defines the capacity of the system to change ventilation in response to a~     change in PaCO2 (ventilatory response).~      Sands et al. proposed and validated a mathematical model based on the ventilatory cycle~     pattern that quantifies the feedback loop. The ratio of ventilatory and cycle duration within~     the PB pattern is defined as the duty ratio (DR), which is the basis to calculate the LG. Any~     temporary breathing disturbance causing a PB pattern with a LG < 1 stabilizes within a few~     breathing cycles. A LG > 1 represents an unstable ventilatory response and slight changes of~     CO2 are accompanied by overshooting and undershooting of the ventilation. In that case, the~     polysomnography shows the typical pattern of waxing and waning of the tidal volume and~     effort.~      HF patients typically present with an increased LG due to an impaired left ventricular~     function and a hyperstimulation of pulmonary vagal receptors. Furthermore, Khoo showed an~     increased chemosensitivity (controller gain) as well as a decreased ventilatory capacity~     (plant gain) in this group of people.~      Sands and colleagues characterized PB considering the mean LG derived from several~     ventilatory cycles during non-REM sleep. This retrospective study of PB in HFrEF patients~     addresses the following questions:~        1. Is a single LG value appropriate to characterize the individual PB?~        2. Does the LG depend on sleep stage and body position?~        3. Does the intraindividual LG variability allow for the discrimination of different PB~          phenotypes and, if so, do these phenotypes differ in further characteristics?~   "
2631|NCT03532399|"~     This study will measure plasma concentrations of bivalirudin in pediatric patients undergoing~     cardiac catheterization, cardiac surgical procedures utilizing cardiopulmonary bypass (CPB),~     or extracorporeal support with ECMO, ventricular support devices (VAD) or lung-assist devices~     (LAD). The aim is to understand the pharmacokinetics of bivalirudin in these settings.~   "
2632|NCT03532386|"~     Infertile men due to oligoasthenospermia with non-tense hydroceles are subjected to ICSI~   "
2633|NCT03532373|"~     This study will complete a randomized controlled trial to quantitatively measure patient~     decisional conflict (Decisional Conflict Scale) in 150 patients treated for CTS with the tool~     compared to 150 patients treated with standard care. The investigators hypothesize patients~     treated for CTS will have lower decisional conflict with the tool.~   "
2634|NCT03532360|"~     this study evaluates whether tolerance to peanuts and tree nuts can be induced in patients~     through a process of oral immunotherapy. Participants will be randomized into groups~     receiving oral immunotherapy and a control group that will receive no intervention~   "
2635|NCT03532347|"~     Endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and fine needle biopsy (FNB)~     are the standard methods for obtaining tissue samples from tumours of the pancreas. The~     diagnostic accuracy by strict criteria is around 75-80%. A non diagnostic sample causes delay~     and the need for a repeat procedure. To date no significant difference has been found between~     standard FNA and standard FNB needles. A novel opposing bevel design (SharkCore) needle for~     FNB may provide better diagnostic performance. The aim of this study is to compare the~     performance of a standard needle and the Sharkcore needle. Patients attending for routine~     biopsy of a suspected pancreatic tumour will be invited to participate. All participants will~     have 3 samples taken with each needle. The samples from each needle will be processed and~     reported separately with the pathologists blinded as to the report from the other needle.~     Following the procedure participants will be observed as normal in the recovery area and~     allowed home later. Further study participation is limited to 1 telephone call at 7 days.~     Participants will be asked if they have developed any new symptoms since the procedure and~     whether they have had to seek medical attention for this.The risks of the study procedure are~     the same as those of a non study procedure. Both needle types are in routine use in our unit.~     The study will be performed in the endoscopy unit of the Freeman hospital. The study is~     funded by a grant from Medtronic the company who make the Sharkcore needle. The study is~     planned to recruit 108 participants over 10 months with a further 6 months of follow up. If~     the new needle is found to perform better its routine use will potentially reduce the delay~     experienced by patients as well as the cost incurred by repeat procedures.~   "
2636|NCT03532334|"~     The central hypothesis and current observation is that PFx gases used as contrast agents~     readily provide functional images of the lung airways including important regional~     ventilation information such as ventilation defect severity and gas trapping. This is a pilot~     proof of concept study to demonstrate the non-inferiority of 19F MRI gas Ventilation imaging~     compared to 133Xe ventilation Scintigraphy in subjects with lung disease. The secondary goal~     of the study is to develop sufficient information to adequately power a pivotal trial of 19F~     MRI gas Ventilation imaging compared to 133Xe Ventilation Scintigraphy~   "
2637|NCT03532321|"~     In hospitals, the improvement of working conditions is often considered secondarily to~     patient satisfaction. Previous studies, showing statistically significant relationships,~     suggested the impact of hospital departments' organization (staff / patient ratio, bed~     distribution, caregiver's assignment), of the work environment, and the working conditions on~     the infectious risk at the hospital departments. In addition, organizational hospital~     constraints and the organization of care could equally have a major impact on the physical~     and psychological health of care workers (stress, fatigue, job satisfaction). To date,~     available data suggest that determinants of occupational stress and fatigue are~     multifactorial.~      This research aims to develop an interdisciplinary approach to link two phenomena that are~     often studied independently while they are closely intertwined: working conditions and~     infectious risk in hospitals departments. Their main objective is to study the relationship~     between stress and caregiver fatigue at the work, organizational determinants and infectious~     risk for patients (healthcare-associated infections: HAIs) and for caregivers (blood exposure~     accidents: BEAs). The secondary objective is to analyze how the individual characteristics of~     the staff, the characteristics of their employment, and the overall organization in the~     hospital departments where they work interact to explain their physical and psychological~     state of health, on the one hand, and their behavior face to work (absenteeism, turnover and~     hand hygiene) on the other hand. The ultimate goal of this research is to be able to propose~     organizational strategies aimed at both reducing the probability of occurrence of~     healthcare-associated infections and preventing occupational risks for caregivers.~   "
2638|NCT03532308|"~     The purpose of this study is to assess the efficacy of Fermented Soy vs. placebo in 72 adults~     with localized prostate cancer prior to radical prostatectomy.~   "
2639|NCT03532295|"~     In this study, the investigators propose to combine epacadostat with radiation therapy (RT),~     avelumab, and bevacizumab in the treatment of recurrent glioblastoma (GBM). The investigators~     hypothesize that this combination provides a powerful synergy between RT and immune~     modulators to produce more robust anti-tumor immune response, induce tumor regression and~     improve overall survival.~   "
2642|NCT03532256|"~     The Center for Disease Control has labeled the opioid prescription drug crisis an epidemic~     in the United States and recently this epidemic has been named a public health emergency.~     Various medical and surgical societies have begun to release general opioid prescribing~     guidelines for providers addressing acute pain, but these do not highlight the patient~     perspective or experience. Identifying an acceptable opioid dose and duration has remained a~     challenge and is a nuanced process. Though policy and provider driven changes may begin to~     augment practice, these avenues may miss a crucial perspective; the patient's.~   "
2643|NCT03532243|"~     Inspiratory muscle training has been an important part of pulmonary rehabilitation program~     directed at patients with COPD. It can increase respiratory muscle strength, relieve dyspnea~     ,improve the quality of life in COPD patients. However, there is no uniform standard for the~     intensity of inspiratory muscle training. By comparing a series of indexes, such as maximal~     inspiratory pressure, maximal expiratory pressure, degree of dyspnea and exercise capacity~     before and after the training under different intensity, a large number of literatures have~     explored the appropriate intensity of inspiratory muscle training. But to date, there are few~     studies about the effects of different intensity of inspiratory muscle training on~     respiratory physiological mechanism. It has been shown that inspiratory muscle training may~     be more beneficial to improve the pulmonary rehabilitation effect of COPD patients with~     inspiratory muscle weakness. So it is not clear whether there is a difference in respiratory~     physiology between patients with normal inspiratory muscle strength and those with lower~     inspiratory muscle strength. Respiratory central drive, as an important physiological index,~     which can be reflected by minute ventilation volume, mouth pressure, mean inspiratory flow~     and diaphragm electromyography,is closely related to the symptoms and the severity of the~     disease.Therefore,the purpose of this study was to investigate the changes of respiratory~     mechanics and central drive in COPD patients at different inspiratory loads, and at the same~     loads between patients with and without respiratory muscle weakness.That can provide more~     evidential evidence for setting up the intensity of inspiratory muscle training.~   "
2644|NCT03532230|"~     The specific aim of this study is to conduct a prospective, multicenter cohort study over~     four months to compare the cost of standard of allopathic care (control group, N=90) versus~     standard of care plus osteopathic manipulative treatment (experimental group, N=90) in a~     cohort of 180 consecutive patients seeking treatment for chronic low back pain at three~     osteopathic clinics and three allopathic medical clinics (offering only standard care)~     located in three different regions of the United States.~   "
2645|NCT03532217|"~     This study study aims to elucidate the immune responses to a shared antigen vaccine~     (PROSTVAC) and tumor specific antigens generated DNA vaccine in combination with checkpoint~     blockade using nivolumab (anti-PD-1), and ipilimumab (anti-CTLA-4). Additionally, the~     investigators will study the impact of the combination immunotherapy on peripheral T cell~     activation, as well as immune response in the tumor microenvironment. Finally, the~     investigators will evaluate the safety and tolerability to this novel personalized~     immunotherapy in combination with checkpoint blockade.~   "
2646|NCT03532204|"~     The role of radiotherapy in metastatic cancer has historically been limited to palliation~     while metastasectomy or radiofrequency has emerged as playing a major role in disease~     control. Although resection is the standard of care for liver metastasis, 80-90% of patients~     are not resectable at diagnosis in particular because of the presence of oligometastases.~     Factors that favour a truly oligometastatic state include a long latent interval between the~     treatment of the primary tumor and the appearance of metastases.~      Oligometastatic cancer is a very heterogeneous disease with respect to several factors~     including the location of the primary tumor. With the advent of extracranial stereotactic~     body radiation therapy (SBRT), higher biological equivalent doses can be safely delivered in~     3 to 5 fractions, thus potentially ablating all the tissue in the treated area while~     protecting more efficiently the hosting organ and healthy tissues surrounding the tumors.~      In patients with liver oligometastases, in-field local control rates at 2 years range from~     70% to 90% with less than 5% severe grade 3 or higher toxicity rates. Retrospective studies~     indicate that roughly 20% of the patients remain disease-free 2 to 4 years after SBRT.~      For patients treated with SBRT some authors found that half of the patients had either no~     metastatic progression or very little progression in terms of number and site of metastases.~     The patterns of failure after SBRT for oligometastases in one organ showed that 73% of~     patients eventually developed new metastases with higher than 80% occurring as new metastases~     in the same index organ. These findings support the idea of an oligometastatic state in which~     aggressive local therapy could improve progression-free survival (PFS).~      With this phase III study, we sought to evaluate the impact of SBRT on PFS at 2 years in~     patients with synchronous or metachronous liver-only oligometastases from colorectal cancers~     patients after a first line chemotherapy for metastatic disease but not having progressed~     during first line chemotherapy and up to 1 year~   "
2647|NCT03532191|"~     PrEP Optimization Intervention (PrEP-OI) is aims to educate healthcare providers on PrEP and~     assist providers in the appropriate targeting of patients at increased risk for HIV~     acquisition, initiating PrEP when appropriate, and providing guidance on the ongoing~     monitoring and adherence counseling of patients on PrEP. The intervention includes a~     web-based panel management tool (called PrEP-Rx) and PrEP coordination (by a PrEP~     Coordinator). The PrEP-OI study will take place among participating primary care clinics~     across the San Francisco Department of Public Health.~   "
2648|NCT03532178|"~     The investigators propose to compare the recovery of neuromuscular blockade from rocuronium~     reversal by sugammadex to succinylcholine in ECT.~   "
2649|NCT03532165|"~     At most institutions, the average patient with clinical concern for PE(pulmonary embolism)~     will have a CT angiogram(CTA) with contrast of the lungs performed to evaluate for a clot.~     However, CTA has risks including contrast- induced allergic reactions and nephropathy, as~     well as radiation which has been linked to development of cancer later in life. There is~     literature that has looked at using lower extremity doppler ultrasound first to evaluate for~     a DVT (deep venous thrombosis) in patients where there is concern for a PE. There is also~     literature showing that emergency medicine physicians can perform adequate lower extremity~     compression ultrasounds (LCUS), at the bedside with results similar to that of the ultrasound~     tech. The goal of this project is to fuse both principles by having emergency medicine~     physicians perform LCUS at the bedside, to help reduce CTA utilization in the evaluation of~     PE.~   "
2661|NCT03532009|"~     This is an international, multicentre, parallel-group, randomised, double-blind, placebo~     controlled, phase II study to evaluate the benefits and risks of using sodium zirconium~     cyclosilicate (ZS) to initiate and intensify renin angiotensin aldosterone system inhibitor~     (RAASi) therapy in heart failure patients.~   "
2905|NCT03528837|"~     Acute kidney injury (AKI) is a complex disorder with clinical manifestations ranging from~     mild dysfunction to complete anuric kidney failure. Its leads to sudden and rapid decline in~     renal excretory function within hours to days,accompanied by accumulation of nitrogenous~     waste products such creatinine,urea and other clinically un measured products~   "
2650|NCT03532152|"~     The study assess the effect of the VR technology (Pure Purr technology) on the recovery of~     the autonomic nervous system in healthy volunteers affected by moderate stress. Study subject~     randomized into two groups: in Group 1 volunteers first be tested with the VR headset A, and~     during the next visit- headset B. Group 2 volunteers first be tested with the VR headset B,~     and during the next visit- headset A. Before, after and during VR session was conducted~     stress modulation and ECG recording.~      The Pure Purr technology combines several audio and visual stimuli aimed at activation of the~     parasympathetic nervous system. Therefore, this study will investigate the effect of this~     technology on the recovery of autonomic nervous system performance after moderate stress.~   "
2651|NCT03532139|"~     This research study is studying a combination of two drug interventions called rosuvastatin~     and enoxaparin as a possible preventative measure against developing venous blood clots (such~     deep vein thrombosis or pulmonary embolism). .~      The drugs involved in this study are:~        -  Rosuvastatin, also known as Crestor~        -  Enoxaparin~   "
2652|NCT03532126|"~     This investigation aims to confirm the safety and effectiveness of Princess VOLUME PLUS~     Lidocaine in midface volume deficit augmentation and includes a long term safety followup.~   "
2653|NCT03532113|"~     Formal education and cognitively stimulating hobbies and profession have a protective effect~     against age-related cognitive decline and Alzheimer's disease. It is therefore possible that~     providing cognitively stimulating interventions at a later age increases neuroplasticity and~     brain resilience. Processes of updating and inhibition are both impaired by aging. Several~     studies have shown that updating can be improved but very few studies targeted inhibition in~     spite of the fact that it is impaired in older adults. The aim of this study is to assess the~     effect of cognitive interventions that will target either of these two components. The~     investigators will examine the effect on behavior, brain measures and transfer tasks. The~     investigators will also assess whether the efficacy varies as a function of personal~     variables such as prior cognitive profile, reserve proxies, genetic polymorphisms and brain~     markers.~   "
2654|NCT03532100|"~     When prescribing a prosthetic foot, clinicians face a dizzying array of choices as more than~     200 different prosthetic feet are available. While these conventional prosthetic feet~     primarily function in the sagittal plane, the intact foot and ankle comprise a complex set of~     joints that allow rotation in multiple planes of motion. Some of these motions are coupled,~     meaning rotation in one plane induces motion in another. One such coupling is between the~     sagittal and transverse planes. For every step, plantar- and dorsi-flexion motion in the~     sagittal plane is coupled with external and internal rotation of the shank relative to the~     foot in the transverse plane. There is no prosthetic foot available for prescription that~     mimics this natural coupling.~      To investigate the need for this coupling, the investigators have built a torsionally~     adaptive prosthesis where the coupling ratio between the transverse- and sagittal-planes can~     be independently controlled with a motor.~      This research has one specific aim: to identify the optimal coupling ratio between~     transverse- and sagittal-plane motions using a novel, torsionally adaptive prosthesis for~     individuals with lower limb amputation. The investigators will conduct a human subject~     experiment wearing the motor-driven and computer controlled torsionally adaptive prosthesis.~     Individuals with lower limb amputation will be asked to walk in a straight line and in both~     directions around a circle while the coupling ratio between transverse- and sagittal-plane~     motions is varied between trials. Participants will be blinded to the coupling ratio.~      The investigators hypothesize that: (1) a coupling ratio exists that minimizes undesirable~     transverse-plane socket torque and (2) there will be a coupling ratio that individuals with~     lower limb amputation prefer.~   "
2655|NCT03532087|"~     The aim of this prospective, randomized, multicenter, open-label, explorative phase II study~     is to identify the impact of (neo)adjuvant denosumab on the systemic immunity and local~     immunologic microenvironment in postmenopausal patients with HER2 negative non-metastatic~     primary breast cancer.~   "
2656|NCT03532074|"~     Indocyanine green is a fluorescent dye used for the intraoperative evaluation of tissue~     perfusion.~      The aim of this study is to evaluate a possible correlation between rectosigmoid~     vascularization and intestinal symptoms in patients needing surgery for rectosigmoid~     endometriosis. Bowel symptoms and rectosigmoid perfusion are assessed before and after~     surgery.~   "
2657|NCT03532061|"~     Caregiver education and training programs that specifically target caregiver informational~     and training needs during the survivorship period have been limited. In recognition of~     families' direct involvement in health care decision-making, health advocacy and care~     provision, programs are needed that can maximize families' caregiving abilities and skills~     and provide them with the information and resources they may need to identify and address~     elderly cancer patients' post-treatment symptom management. The goal of this study was to~     implement and evaluate the efficacy of a short-term problem-solving skills training program~     (relative to participating in a caregiver support group) for familial caregivers to lower~     income older (55+) post-treatment cancer patients.~   "
2658|NCT03532048|"~     This is a feasibility study of a culturally adapted version of Healthy Dads Healthy Kids for~     Hispanic families. The adapted version called Papás Saludables, Niños Saludables is a~     father-targeted program for child obesity prevention and weight loss for fathers. The~     feasibility study will be conducted with 40 Hispanic families. Baseline assessments (T0) will~     be completed on all participating family members, followed by randomization to start the~     program immediately (intervention group), or 6-7 months later (wait-list control). Post~     assessments (T1) will be completed on the full sample once the intervention group has~     participated in the 10 week Papás Saludables, Niños Saludables program. A process evaluation~     will be conducted to assess the feasibility outcomes of the study.~   "
2659|NCT03532035|"~     This is a randomized, controlled, open-label, multicenter study to evaluate the safety,~     tolerability, pharmacokinetic (PK), and adenovirus (AdV) antiviral activity of multiple~     ascending doses of IV brincidofovir (BCV). Approximately 30 eligible subjects will be~     sequentially enrolled into 1 of 3 planned cohorts. Within each cohort, subjects will be~     randomized in a 4:1 ratio to receive IV BCV dosed twice weekly (BIW) (on Days 1, 4, 8, and~     11) or to receive investigator-assigned standard of care (SoC).~   "
2660|NCT03532022|"~     This study is an open-label, randomised, titration-blinded, parallel arm, multicenter study~     to compare twice daily Chronocort® with standard care in participants with Congenital Adrenal~     Hyperplasia (CAH). This study will be conducted in the USA.~   "
2662|NCT03531996|"~     The major goal of this study is to conduct a prospective, longitudinal study of autoimmune~     PAP to examine outcome measures for disease severity of potential use in clinical practice~     and/or clinical research studies. These results will impact the field by: 1) improving an~     understanding of the clinical course of autoimmune PAP, 2) providing information on various~     clinical outcome and quality of life outcome measures to guide patients and physicians in~     making treatment choices, and 3) facilitate the development of pharmaco-therapeutics for~     autoimmune PAP and 4) better informing PAP researchers.~   "
2663|NCT03531983|"~     We prospectively reviewed the results of 30 patients who had undergone intramedullary~     fixation with a gamma nail for femur trochentric fractures in AUH. within 1 year~   "
2664|NCT03531970|"~     The purpose of this prospective, randomized, double-blind study was to compare the success~     rate of IAN block injection carried out with two cartridges of 2% lidocaine with 1:80000~     epinephrine each combined with 0.2 ml dexamethasone versus two cartridges of 2% lidocaine~     with 1:80000 epinephrine each combined with 0.2 ml sterile distilled water for endodontic~     treatment of mandibular molars with symptomatic irreversible pulpitis.~   "
2665|NCT03531957|"~     This is a randomized double-blind/placebo study evaluate the efficacy of ASN002 in subjects~     with moderate to severe atopic dermatitis (AD).~   "
2666|NCT03531944|"~     Background: In Singapore, the prevalence of diabetes mellitus was approximately 12.8% in 2014~     and the prevalence was projected to rise to 22.7% in 2035. In view of the complexity of~     diabetes management, collaborative efforts by nurses and other allied health professionals~     such as dietitians and pharmacists have shown to play a significant role in improving~     clinical care of individuals with diabetes. Currently in Singapore, the effectiveness of the~     collaborative care model has only been evaluated prospectively in the primary and tertiary~     care settings involving clinical pharmacists. The impact of the unique, synergistic roles of~     community pharmacists with family physician on the clinical, humanistic and economic outcomes~     have yet to be elucidated.~      Aims: This study aims to evaluate the clinical, humanistic, and economic outcomes of a~     community pharmacist-involved collaborative care model in the management of individuals with~     type 2 diabetes mellitus.~      Hypothesis: Incorporating community pharmacist into the care model with family physician and~     nurse can improve the clinical, humanistic, and economic outcomes of individuals with type 2~     diabetes mellitus.~      Methods: This study is a prospective, open label, parallel arm, randomized controlled trial.~     The study will be conducted over 6 months at a family medicine clinic in Singapore.~     Individuals aged 21 years and above, diagnosed with type 2 diabetes (HbA1c > 7.0%) and taking~     5 or more chronic medications will be eligible. Individuals with Type 1 diabetes or who are~     unable to communicate independently in English, Mandarin or Malay will be excluded from this~     study. The participants will be randomly assigned to 2 groups using a random number generator~     or an equivalent: (1) Usual diabetes care with physician (control), (2) diabetes care with~     physician and community pharmacist (intervention). The community pharmacist will adopt the~     core elements of the medication therapy management model in reviewing the medications of~     participants as well as provide relevant lifestyle counselling and health education via a~     face-to-face consultation at the clinic and subsequently through telephonic correspondences.~     The primary outcome will be change in HbA1c over 6 months. Secondary outcomes include blood~     pressure, lipid markers, distress level, self-care capabilities, quality of life,~     productivity, and direct medical costs.~      Significance: The outcomes of the community pharmacist-involved collaborative care model will~     support future implementation and integration of this care model into the standard of care in~     Singapore so as to optimize the management of type 2 diabetes.~   "
2667|NCT03531931|"~     Gastric cancer is the one of the leading cause of cancer death in the worldwide. Gastric~     cancer originates from the most superficial mucosal epithelial cells of the stomach wall,~     which can occur in various parts of the stomach, and can invade different depths and breadth~     of the gastric wall. Without chemotherapy treatment the GC patients' Median Survival Time~     (MST) lasts only 3-4 months. Although treated with multi-chemotherapy MST has been improved,~     the drugs show strong toxicities in the patients. Thus the more accurate, lower toxicity,~     targeted antitumor drugs are put into second-line treatment program for advanced gastric~     cancer.~      Apatinib, a novel targeted inhibitor of VEGF receptor 2 (VEGFR2), shows significant antitumor~     activity in the patients with GC. The purpose of this study is to determine whether apatinib~     plus capecitatine can improve progression free survival in patients with advanced gastric~     cancer.~   "
2668|NCT03531918|"~     This phase I/II trial studies the side effects and best dosing frequency of gemtuzumab~     ozogamicin when given in combination with granulocyte colony stimulating factor (G-CSF),~     cladribine, cytarabine and mitoxantrone (GCLAM) and to see how well they work in treating~     participants with acute myeloid leukemia or high-grade myeloid tumors (neoplasms) that have~     not been previously treated. Antibody-drug conjugates, such as gemtuzumab ozogamicin, act by~     directly delivering toxic chemotherapy to cancer cells. Granulocyte colony stimulating factor~     is a growth factor used to stimulate leukemia cells and render them more sensitive to~     chemotherapy drugs. Drugs used in chemotherapy, such as cladribine, cytarabine and~     mitoxantrone, work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Giving gemtuzumab~     ozogamicin in combination with G-CSF, cladribine, cytarabine and mitoxantrone hydrochloride~     may work better in treating participants with acute myeloid leukemia or high-grade myeloid~     neoplasm.~   "
2669|NCT03531905|"~     12 week study to assess the LDL-C lowering efficacy, other lipid and glycemic measures, and~     safety of bempedoic acid/ezetimibe FDC compared to ezetimibe and placebo in patients with~     type 2 diabetes (T2D) and elevated LDL-C~   "
2670|NCT03531892|"~     The study will investigate the efficacy and safety of an oral dose of AJM300 960 milligram~     (mg)/dose administered three times daily for 8 weeks in participants with active ulcerative~     colitis.~   "
2671|NCT03531879|"~     The purpose of this study is to better understand the association between the postprandial~     biomarker responses after a food challenge with the development of cardiovascular diseases in~     healthy subjects~   "
2672|NCT03531866|"~     This study will evaluate DigiKnowIt News, a web-based resource to educate youth about~     pediatric clinical research. Youth will be randomly assigned to one of three groups (1.~     Intervention Version A; 2) Intervention Version B; 3) Wait-list control).~   "
2673|NCT03531853|"~     The purpose of this study is to develop and demonstrate new technologies that will enable a~     non-contact, compact eye imaging system based on OCT to assist an early responder in acute~     care settings (like an emergency room) to help assess eye trauma and inflammation (swelling~     inside the eye).~   "
2733|NCT03531073|"~     MONITOR is a cohort study recruiting patients with a new diagnosis of psoriatic arthritis~     (PsA) which will establish outcomes using a pragmatic feasible 'treat to target' approach in~     a real-life clinic population. It is the central cohort for a planned Trials Within Cohorts~     (TWiCs) design which will test alternative therapies and interventions in embedded clinical~     trials comparing outcomes to those receiving standard care in the cohort.~   "
2734|NCT03531060|"~     This is a Phase 1b study investigating the safety and tolerability of IRl790 as adjunct~     therapy in patients with Parkinson disease. IRL790/placebo is taken for 28 days.~   "
23483|NCT03259594|"~     Renal functional reserve may be improved in patients with simple renal cysts after~     laparoscopic deroofing.~   "
2674|NCT03531840|"~     Background:~      The drug olaparib may stop cancer cells from fixing damage to their DNA. It has been approved~     to treat certain cancers in people that were born with a mutation in the BRCA gene. It has~     not been approved for treating mesothelioma. But some people with mesothelioma have mutations~     in a gene, BAP1 related to BRCA. Researchers want to see if olaparib can work in patients~     with mutations in this gene. They also want to see if works on mutations in other genes or~     patients without any mutations. They want to see if olaparib causes mesothelioma tumors to~     shrink.~      Objective:~      To study the effect of olaparib on mesothelioma.~      Eligibility:~      People ages 18 and older with malignant mesothelioma that has already been treated~      Design:~      Participants will be screened with~      Sample of tumor tissue or fluid~      Medical history~      Physical exam~      Blood, heart, and urine tests~      Scans and x-rays~      Participants will give blood and tissue samples. These will be genetically tested.~      The study will be done in 21-day cycles.~      Participants will take tables of the study drug 2 times each day. They will get information~     on what food and drugs to avoid during the study. They will get information about birth~     control. They will keep a diary of doses and symptoms.~      Participants will have blood and urine tests and scans every few weeks.~      Participants will be told any important genetic testing results.~      Participants will stay in the study until their disease gets worse or the participant or~     their doctor chooses to stop it.~      About 30 days after stopping the study drug, participants will have a follow-up visit. They~     will have a medical history, physical exam, blood tests, and scans.~      Some participants will continue to have scans every 6 weeks.~   "
2675|NCT03531827|"~     Background:~      Some prostate cancer keeps growing even when testosterone in the body drops to very low~     levels. This is called castrate-resistant prostate cancer. One treatment is enzalutamide.~     This is a modern hormonal therapy. But it only works for a certain amount of time and then~     the cancer becomes resistant to it. Researchers want to see if adding the treatment CRLX101~     could make enzalutamide work again for people who have already had it.~      Objective:~      To test a new way of treating prostate cancer using CRLX101 plus enzalutamide in people with~     certain prostate cancer who already had enzalutamide treatment.~      Eligibility:~      Adults ages 18 years and older with metastatic, castration-resistant prostate cancer who have~     had enzalutamide treatment~      Design:~      Participants will be screened with a medical history and physical exam. They will have blood~     and urine tests. They will have a scan of the chest/abdomen/pelvis. They will have a bone~     scan.~      Participants will get treatment in cycles. A cycle lasts 28 days. They will take enzalutamide~     by mouth once a day. They will get CRLX101 through an IV every 1 or 2 weeks.~      Participants will repeat screening tests throughout the study.~      Participants will have a follow-up visit 3 4 weeks after they stop taking the study drug.~     They will repeat most screening tests and have an electrocardiogram.~   "
2676|NCT03531814|"~     Background:~      Neurofibromatosis type 1 (NF1) is a genetic disorder. It has a broad variety of effects on~     the body. Up to half of people with NF1 get plexiform neurofibromas (PNs). These are benign~     tumors. But they can have serious effects like pain and disfigurement. To treat PNs, a person~     may have to take medicine every day for a long period of time. Researchers think that it will~     be important for people to take the medicine regularly for it to work. They want to study how~     well people with NF1 follow their treatment plan for PNs.~      Objective:~      To study how often people with neurofibromatosis type 1 take medicine that has been~     prescribed to them for treating plexiform neurofibromas.~      Eligibility:~      People ages 3-59 already enrolled in an NF1 clinical trial~      Design:~      Participants will need access to the internet to do the study activities.~      Parents or caregivers will do some study activities for child participants.~      Participants will complete 5 questionnaires. They will take about 20 minutes total. The~     topics will be:~      Demographic data~      Recent life events~      How much pain interferes with daily life~      Ability to focus and pay attention to tasks~      Emotional distress or depression~      Participants will mark down every time they take a dose of the medicine in their clinical~     trial. They will use a form the researchers give them. The pill bottles they get in their~     trial will have a chip in the cap that will record when it is opened. Participants will keep~     a daily diary of their medicine. Their pills will be counted at clinical trial visits.~      Participants may have more short questionnaires. They may have interviews by phone or video.~   "
2677|NCT03531801|"~     The purpose of the present study is to investigate pressure algometry and pressure-induced~     referred pain areas in pain free individuals with a history of distal radius fracture (fully~     recovered) compared with age and gender matched healthy controls without history of fracture.~     It is hypothesized that individuals with a recovered radius fracture will have a facilitated~     referred pain patter towards the wrist but normal pressure pain sensitivity.~   "
2678|NCT03531788|"~     This study is a longitudinal, randomized control trial evaluating the use of two commercially~     available dynamic arm support devices (Armon Ayura and JAECO WREX) to promote participation~     in activities of daily living in non-ambulatory individuals with Duchenne muscular dystrophy~     (DMD) with upper extremity weakness.~   "
2679|NCT03531775|"~     The diaphragm is the main muscle assisting breathing. This study aims to assess the use of~     MRI in patients with diaphragmatic weakness and patients with Chronic Obstructive Pulmonary~     Disease (COPD) who have hyperinflation. In some patients with COPD, air gets trapped in the~     lungs and causes them to expand too much; this is called hyperinflation. These patient report~     severe breathlessness, which may be in part because of their diaphragm. It is known that~     posture impacts lung function and breathing and the investigators want to assess the effect~     of posture on the diaphragm. Currently, lung function tests and CT or ultrasound scan are the~     main tests used to check how the diaphragm works. Recently, at University of Nottingham, an~     new imaging approach has been developed that uses an upright MRI allowing testing the~     patients in lying position and seated/standing in the same scanner. This may help researchers~     test the diaphragm position and shape more accurately and check the effects of posture on the~     diaphragm. This may help researchers and clinicians better understand the relationship~     between postural changes in diaphragm position and shape and symptoms.~      The study will take place at the clinical research MRI centre at Nottingham Medical School,~     which is next to Queen's Medical Centre. The investigators want to recruit healthy~     volunteers, patients with diaphragmatic weakness and patients with COPD whose lungs are~     hyperinflated. The study will last 2 years, and the participants are asked to attend the~     imaging centre only once, where they will give consent and will be scanned at the same visit,~     which is expected to take 2 hours to complete. They will be scanned on two scanners: lying~     and seated/standing in the new upright scanner and lying in a conventional scanner. The~     investigators will not use any contrast for imaging, i.e. participants will not be injected~     with a dye and they will breathe air.~   "
2680|NCT03531762|"~     This study will investigate in healthy subjects (i) the effect of omeprazole (proton pump~     inhibitor) co-administration on the single dose PK of tepotinib under fed conditions, and~     (ii) the effect of food on the single dose PK of tepotinib after co-administration of~     omeprazole and tepotinib. Furthermore, the study will assess the safety and tolerability of~     tepotinib alone and upon co-administration of omeprazole.~   "
2681|NCT03531749|"~     Human immunodeficiency virus (HIV) infection continues to be a pandemic, Mexico has around~     184,000 people infected by this virus. A common metabolic problem for these patients is~     oxidative stress (OS), which has been related with the progression of the disease and the~     presence of comorbidities. Pomegranate is a fruit rich in antioxidants, which potentially can~     inhibit or reduce deleterious metabolic compounds resulting from OS; however; it has never~     been tested in patients infected with HIV. The present project was done in patients HIV+ from~     state of Hidalgo in order to see the effects of microencapsulated red pomegranate juice~     (MRPJ) and ascorbic acid (AA) on antioxidant activity and lipid peroxidation both biomarkers~     of oxidative stress. Sixty subjects were recruited, 30 HIV positive (HIV+) and 30 HIV~     negative (HIV-). Three subgroups (n=10) were formed from each group: 1) supplemented with~     (1g/d) MRPJ; 2) supplemented with 1g/d AA; and 3) control group (unsupplemented). The~     intervention lasted 90 days and blood samples were taken four times: at the beginning and~     every 30 days. Antioxidant activity in the blood serum was measured by the DPPH~     (2,2-diphenyl-1-picrylhydrazyl) and ABTS + (2,2'-azino-bis(3-ethylbenzothiazoline-6-sulphonic~     acid) methods while lipid peroxidation by malondialdehyde (MDA) levels which was measured by~     TBARS method. The baseline results showed a significant decrease of antioxidant activity in~     HIV+ groups compared to the HIV- groups, although there was no significant difference in~     lipid peroxidation, as measured by MDA assay levels. Several studies suggest that the~     reduction of antioxidant activity is a consequence of the infection and the antiretroviral~     treatment, although the organism tries to reestablish it unbalance it usually fails, thus~     (OS) is significant in these patients. The groups that received AA had antioxidant activity~     greater than the MRPJ treated. MRPJ treatment, however, the groups that received MRPJ had~     significantly reduced lipid peroxidation. Reduced lipid peroxidation could have more~     beneficial effects on HIV+ subjects since the reduction of markers of OS, such as lipid~     peroxidation, has been associated with reductions in the risk of death from HIV.~   "
2682|NCT03531736|"~     The main purpose of this study is to learn if a new combination of chemotherapy, in~     combination with low-dose radiation, will be safe for the patient, and at the same time~     provide the best opportunity to cure the bone marrow cancer. The combination of chemotherapy~     and radiation described in the study is considered 'low intensity.' Although the chemotherapy~     agents used in this study and for transplant are FDA approved, the chemotherapy treatment and~     conditioning regimens or combinations listed in this consent are not yet FDA approved.~      The CliniMACS device is FDA approved for one type of T cell depletion (positive selection of~     the stem cells) but not approved yet for other type of T cell depletion, which is being~     studied on this protocol. This pilot study, along with other studies will serve as the basis~     for FDA approval, if outcomes are favorable.~   "
2683|NCT03531723|"~     External Ventricular Deviation (EDV) is a medical device that provides transient and~     controlled external drainage of cerebrospinal fluid (CSF). This device can also monitor~     intracranial pressure (ICP). SEV is an emergency measure indicated for acute hydrocephalus~     and / or intracranial hypertension (HTIC). Weaning from a DVE should be considered as soon as~     possible from the moment the patient's clinical condition allows it. There is no consensus on~     how to wean SEVs.~      The main objective of this study is to evaluate inter and intraobserver reproducibility of~     the measurement of the 3rd ventricle size by ultrasound in patients receiving a DVE~     withdrawal test.~   "
2684|NCT03531710|"~     To evaluate the long-term safety, tolerability and potential efficacy, patients who~     previously participated in V203-AD study will be eligible to participate in the extension~     study and will receive 3 or 5 doses of UB-311 within a 96-week treatment period followed by a~     12-week follow-up period.~   "
2685|NCT03531697|"~     This study will assess the bioequivalence of Loteprednol Etabonate and the reference listed~     drug (RLD)~   "
2686|NCT03531684|"~     This study is designed to evaluate the safety and efficacy of MMFS for improving cognition~     and global function in patients with probable mild Alzheimer's disease.~   "
2687|NCT03531671|"~     The purpose of the study is to investigate if a novel instrument called a Binocular Optical~     Coherence Tomographer (OCT) may resolve many of the issues with the assessment of patients~     with cataract.~   "
2688|NCT03531658|"~     The study aims to evaluate how preconception and early prenatal environmental factors can~     potentially influence health outcomes for both mother and child during pregnancy and~     postnatally.~   "
2689|NCT03531645|"~     The goal of this clinical research study is to learn if fulvestrant and palbociclib can help~     to control low-grade serous ovarian cancer. The safety of this drug combination will also be~     studied.~      This is an investigational study. Fulvestrant and palbociclib are both FDA approved and~     commercially available for the treatment of several types of cancer. Their use in patients~     with low-grade serous ovarian cancer is investigational. The study doctor can explain how the~     study drugs are designed to work.~      Up to 15 participants will be enrolled in this study. All will take part at MD Anderson.~   "
2690|NCT03531632|"~     The primary goal of this study is to characterize the safety, tolerability, and maximum~     tolerated dose (MTD) of MGD007 when combined with MGA012. Pharmacokinetics (PK),~     immunogenicity, pharmacodynamics (PD), and the anti-tumor activity of the combination of~     MGD007 and MGA012 will also be assessed.~   "
2691|NCT03531619|"~     Both dizziness and neck pain are common complaints in the Norwegian population. The cervical~     spine has a highly developed proprioceptive system, which is involved in head and gaze~     stabilization as well as postural control. Thus, it has been argued that dizziness and/or~     unsteadiness can occur due to loss of or inadequate stimulation of neck receptors in patients~     with neck pain. Still, the notion of dizziness due to cervical dysfunction is a controversial~     topic. However, clinicians report that patients referred for dizziness often complain of neck~     pain, and vice versa.~      This study is a multi-center study including patients referred to 1) a neuro-otologic clinic~     due to dizziness and 2) a rehabilitation clinic due to neck pain. Both clinics are tertiary~     care university clinics. The study explores the prevalence, severity and spectrum of symptoms~     as well as clinical findings in patients with various combinations of dizziness and neck~     pain. The aim is to see if these patient groups differ from each other in terms of clinical~     characteristics, symptoms and quality of life. Additionally, the aim is to examine if there~     is a relationship between neck dysfunction and dizziness, and last, if the symptoms persist~     longer in patients with both dizziness and neck pain.~   "
2692|NCT03531606|"~     The purpose of this clinical trial study was to evaluate the prevalence of colon cancer among~     the symptom (s) of anterior resection syndrome that may occur after surgery in patients for~     efficacy and safety in Metchnik probiotic ingestion.~   "
2767|NCT03530631|"~     The purpose of this balanced-placebo design study is to pilot a larger study to further~     explore the current evidence that stimulant medications are not cognitive enhancers, despite~     this rampant belief in young adults. While the lack of cognitive enhancement from stimulant~     medication has been documented in prior research, this study is the first to utilize~     neuroimaging technology to examine brain regions activated during neurocognitive tasks when~     participants believe they have been administered stimulant medication or placebo.~   "
2693|NCT03531593|"~     Currently there are no guidelines for monitoring hepatic fibrosis associated with long term~     MTX use. Routine liver biopsies are not being done as a part of surveillance due to potential~     complications like bleeding and pneumothorax. Non-invasive markers like~     gammaglamyltransferase (GGTP), Alkaline Phosphatase (AlkPhos), Alanine aminotransferase (ALT)~     and aspartate aminotransferase (AST) are deranged at a late stage and may not be helpful in~     detecting early fibrosis. The current study will utilize a sensitive, but noninvasive, test~     to evaluate for hepatic fibrosis. We are attempting to screen for early detection of fibrosis~     due to MTX before it progresses to irreversible cirrhosis and end-stage liver disease. Based~     on the results of this pilot study, ultrasound elastography could be used to prospectively~     study a larger population to establish guidelines for monitoring safety and hepatic~     complications with MTX. The influence of other co-morbid factors like obesity, alcohol~     ingestion and smoking is critical to identifying high risk patients who may require closer~     monitoring. We follow close to 550 patients with IBD. If we presume that at least 20%~     patients are currently receiving methotrexate, we will be able to recruit enough patients for~     this pilot study.~   "
2694|NCT03531580|"~     In the Ghent University, an upgrade of the MRI-scanner used for research from Siemens Trio~     Tim to Siemens Prisma Fit is planned in the near future. As a change of MRI hard- and~     software might influence brain images, it is necessary to evaluate the images before and~     after the upgrade.~   "
2695|NCT03531567|"~     Study will look at the effect of a game-based, task-oriented home exercise program on~     adherence in persons with chronic (> 6 months post) stroke as compared to a standard home~     exercise program. The study will also look at the effect of a game-based, task-oriented home~     exercise program on upper extremity motor function and occupational performance in persons~     with chronic (> 6 months post) stroke as compared to a standard home exercise program.~     Finally, the study will look at barriers and facilitators to successful use of the~     game-based, task-oriented home exercise program in the home setting.~   "
2696|NCT03531554|"~     To test if a ketone-ester based drink can boost muscle mitochondrial function in vivo in~     patients with VLCADD in order to establish a rational basis for therapeutic use in this~     disorder.~   "
2697|NCT03531541|"~     This study evaluates the hypoalgesic effect of the TENS application associated with joint~     manipulation of the cervical region in healthy individuals. One group had both active~     treatments, the other group received both placebo treatments, the third and fourth group~     received only one of the two treatments actively and the other placebo~   "
2698|NCT03531528|"~     Chronic plaque psoriasis is frequently associated with obesity and previous studies have~     shown that a calorie-controlled diet inducing body weight loss improves symptoms and~     increases the response to pharmacologic treatment. Besides, clinical improvement has been~     directly correlated with the amount of weight loss. Short-term very low-calorie ketogenic~     diets are responsible for substantial weight loss and attenuate systemic inflammation to a~     higher extent than moderately hypocaloric diets. This intervention has been recently~     demonstrated to restore, after only 4 week, the response to biological therapy in a patient~     suffering from relapsing moderate-to-severe plaque psoriasis and obesity-related metabolic~     syndrome. We investigated the efficacy of an aggressive weight loss program with a ketogenic~     induction phase in a single-arm trial that could provide the rationale for a large randomized~     trial.~   "
2699|NCT03531515|"~     Reactive or secondary thrombocytosis is defined as abnormally high platelet count (≥4,50,000~     platelets per micro-liter) in the absence of chronic myeloproliferative disease. In~     critically ill patients reactive thrombocytosis is not uncommon during recovery phase and an~     association has been seen with poor outcome and increased risk of subsequent VTE. However,~     not all patients with infection respond with thrombocytosis. No study has enumerated the risk~     factors or predictors of reactive thrombocytosis in critically ill septic patients.~   "
2700|NCT03531502|"~     The goal of this study is to determine the optimal treatment for patients who receive a~     single shock from their implantable cardioverter defibrillator (ICD). All participants in~     this study will be fitted with a special electrode vest to detect the origin of heart rhythm~     abnormalities and then they will undergo a procedure called Non-Invasive Programmed~     Stimulation (NIPS). This procedure involves sedating a participants with anesthesia and then~     using the participant's own ICD to try to stimulate the heart to go into ventricular~     tachycardia. If this procedure is unable to induce the participant into ventricular~     tachycardia, then the participant will just be managed with usual care and will not be placed~     on any additional medications and will not undergo an ablation. However, if the NIPS induces~     the ventricular tachycardia, the electrode vest will be used to determine the origin of the~     abnormal heart rhythm inside the heart. After a successful NIPS procedure, the participants~     will be randomly assigned to either be placed on medication therapy or undergo catheter~     ablation. The outcomes from all three groups will be compared and the researchers hope to~     better understand which participants are most likely to benefit from watchful waiting versus~     medication versus catheter ablation.~   "
2701|NCT03531489|"~     The study is a two-part small scale, open-label, pilot study to evaluate feasibility and~     proof-of-concept for a respiratory assist medical device. The study population will consist~     of severe Chronic Obstructive Pulmonary Disease (COPD) subjects.~   "
2702|NCT03531476|"~     The study is evaluating an intervention consisting of a five week online mindfulness program~     for patients being referred to the Pain Clinic and triaged to eConsult. A pain specialist~     will be in contact with the patient's family physician to confirm it's appropriate and then a~     therapist will initiate contact with the patient to assess eligibility. The therapist will be~     a registered health professional with experience with patients with chronic health problems~     and will be supporting the online program where the participant will have communication~     access to them. Questionnaires will be sent at three time points to assess changes.~   "
2703|NCT03531463|"~     The Nordic DeltaCon Trial is a prospective, semi-blinded, randomized, controlled,~     multi-center and multi-national trial comparing reverse prosthesis and non-operative~     treatment in displaced proximal humerus fractures, in the elderly patients aged 65 to 85~     years with displaced OTA/AO group B2 or C2 fractures (According to the new 2018 revision:~     AO/OTA (Orthopaedic Trauma Association) group 11-B1.1, 11-B1.2 and 11-C1.1, 11-C3.1. )~   "
3471|NCT03521427|"~     The aim of the study is to determine the effetiveness of the intensive upper and lower limbs~     therapy to improve the funtional outcomes and to minimize ther energetic spendings during~     funtional activities in Cerebral Palsy patients.~   "
2704|NCT03531450|"~     This is a single-center, randomized pilot study to be conducted at Massachusetts General~     Hospital. The purpose of this study is to examine the non-pharmacological impact of Cognitive~     Behavioral Therapy (CBT) on gastroparesis symptoms and other clinical co-comorbidities such~     as pain, depression, anxiety, and catastrophizing. A subset of the CBT trial patients will~     undergo careful phenotyping pre- and post- intervention with brain MRI, autonomic function~     test (AFT), gastric emptying scintigraphy (GES), wireless motility capsule test (WMC), and~     nutrient drink test (NDT) to determine the impact of CBT on these metrics in patients with~     gastroparesis. Patients randomly assigned to a standard medical treatment (SMT) group will be~     treated by the standard of care. Characterization of these relationships or lack thereof can~     help guide future development of more targeted approaches and optimize treatment strategies~     for gastroparesis.~   "
2705|NCT03531437|"~     The purpose of this study is to compare the effects of Zoely® and Minidoz® on hemostatic~     profiles~   "
2706|NCT03531424|"~     The purpose of this study is to compare revascularization strategy and its immediate results~     after augmented-reality computed tomography angiography (CTA) guided vs. standard angiography~     guided percutaneous coronary intervention (PCI) in native coronary lesions.~   "
2707|NCT03531411|"~     The Richmond Health and Wellness Program (RHWP) is an innovative and emerging nurse-led~     inter-professional wellness and care coordination model that represents a holistic and~     integrated approach to community based care. The model addresses unmet health care needs of~     vulnerable adults residing in low-income housing designated for older adults with a goal of~     helping them to age in place while improving quality of life through health equity. Through~     the promotion of wellness and care coordination among vulnerable older adults, RWHP will~     connect participants to resources that meet their health, nutritional, and safety needs and~     provide a meal to address nutritional needs and food insecurity.~   "
2708|NCT03531398|"~     The aim of the current study is to investigate the postprandial metabolic response to~     typically consumed fat and carbohydrate doses in single meals. An additional aim is to~     validate the use of dry blood spot (DBS) for triglyceride analysis versus venous blood~     sampling.~   "
2709|NCT03531385|"~     There are few studies in the literature regarding increased frequency of neuropathic pain and~     sleep disturbance and decreased quality of life in Behçet's disease. Frequency of central~     sensitization was not investigated in patients with Behçet's disease before. In this study,~     it is aimed to investigate the frequency of central sensitization, neuropathic pain, sleep~     disorder and quality of life and their relation to each other in Behcet's disease.~   "
2710|NCT03531372|"~     Evaluation of the clinical efficacy of two medical devices, Mipolixin® and Poliprotect®, in~     improving the overall symptom severity of functional dyspesia and/or heartburn~   "
2711|NCT03531359|"~     Children develop anxiety during the induction of anaesthesia and video-games might reduce or~     alleviate it. The investigators intend to conduct a clinical trial to study the effect of~     tablet-based interctive games on alleviating preoperative anxiety.~   "
2712|NCT03531346|"~     Tear osmolarity refers to the amount of osmotically active particles in tears and has been~     reported as one of the best diagnostic test for dry eye disease. Our research focused on~     following changes in tear osmolarity and ocular symptoms in the time-course of one year after~     refitting habitual contact lens wearers or fitting novices with modern daily disposable soft~     contact lenses. Fifty-six contact lens wearers aged (mean ± standards deviation) 26 ± 4 y/o~     were refitted with Silicone-Hydrogel (Delefilcon A) or Hydrogel (Omafilcon A) lenses.~      Study included seven visits: baseline measurement before the study, two visits for contact~     lens fit and control and follow-up measurements after three, six, and 12 months of contact~     lens wear followed by measurements on bare eye according to the baseline scheme (post-study~     visit).~      An impedance-based osmometer was used to collect samples from the lower tear meniscus. A~     standard Ocular Surface Disease Index (OSDI) questionnaire was used to monitor~     subject-reported ocular symptoms. Statistically significant differences were noted in tear~     osmolarity in the time course of the study for both eyes.~      An improvement in tear osmolarity was most prevalent among subjects with high initial tear~     osmolarity. Low osmolarity levels were maintained after the study.~      The findings of this prospective study will reveal that habitual contact lens wearers or~     novices may benefit from refitting with modern daily disposable soft contact lenses.~   "
2713|NCT03531333|"~     The main goal of high grade glioma (HGG) surgery is to achieve gross total resection (GTR)~     without causing new neurological deficits1-8. Intraoperative navigated high resolution~     ultrasound (US) is a promising new tool to acquire real-time intraoperative images to~     localize and to resect gliomas9-12. The aim of this study was to investigate whether~     intraoperative guided surgery leads to a higher rate of GTR, when compared with standard~     non-ultrasound guided surgery.~   "
2714|NCT03531320|"~     Part 1: Dose-Escalation Phase (Phase 1b) The primary objective is to assess the safety and~     tolerability of increasing doses of D07001 softgel in patients with unresectable locally~     advanced or metastatic gastrointestinal (GI) cancer.~      Part 2: Dose-Expansion Phase (Phase 2) The primary objective is to assess the safety and~     tolerability of D07001 softgel in patients who have achieved stable disease or better~     following first line chemotherapy or combined chemoradiotherapy (CCRT) for unresectable~     metastatic or locally advanced biliary tract cancer (BTC)~   "
2715|NCT03531307|"~     In neurosurgery, brain tumor patients show increased levels of lactate at the beginning of~     surgery. This has been related to malignancy. Ki-67 is a cell proliferation index used as a~     marker of tumor mitotic activity.~      This research aims to describe the correlation between lactate levels and the Ki-67 index in~     patients with brain tumor.~   "
2748|NCT03530878|"~     Hip dysplasia is a complex problem that exists on a spectrum from mild to severe disease.~     Periacetabular osteotomy (PAO) remains the gold standard for most patients with dysplasia;~     however, the procedure is quite invasive making the decision to proceed in cases of mild~     disease difficult. Hip arthroscopy (HA) is an alternative minimally invasive technique that~     can be used to address mild dysplasia. Nevertheless, HA has less capability for correction~     and in rare instances can exacerbate instability in the dysplastic hip. There is a paucity of~     data examining outcomes between these two treatment strategies for this challenging problem.~   "
3606|NCT03519672|"~     The purpose of this study is to assess the psychometric properties of a recently developed~     congenital thrombotic thrombocytopenic purpura (cTTP)-specific patient-reported outcomes~     (PRO) instrument.~   "
2716|NCT03531294|"~     Study eyes will be assigned randomly (1:1 ratio) to one of the following 2 treatment arms.~     Randomization of PDR subjects will be limited to 50% of each arm.~      Group 1- Subjects will be seen every month, 28 days (+ 7 days), for 52 weeks. All subjects~     will receive IAI at baseline, after eligibility is confirmed. Week 4 through week 48,~     subjects will be seen monthly and treated with IAI PRN (pro re nata) according to, same day,~     central reading center (CRC) determined DRSS level.~      Monthly treatment with IAI will continue until a greater than or equal to 2 step DRSS level~     improvement is achieved, relative to screening/baseline DRSS based on CRC assessment OPTOS~     fundus photos (FP). Subjects who have baseline proliferative diabetic retinopathy (PDR) (DRSS~     Level 61-71) will continue to receive monthly IAI until a greater than or equal to 2 step~     DRSS improvement is achieved as determined by CRC assessment of OPTOS fundus photos relative~     to screening/baseline DRSS, and PDR is quiescent according to the treating investigator.~      Treatment with IAI will be reinitiated if a 1 step worsening of DRSS occurs compared to best~     DRSS score achieved, determined by CRC evaluation of OPTOS fundus photos (this equates to~     less than a 2 step DRSS improvement compared to baseline DRSS). If such worsening is~     detected, the subject would resume monthly IAI until a greater than or equal to 2 step DRSS~     improvement compared to baseline is achieved, as determined by CRC assessment of OPTOS fundus~     photos. In addition, retreatment will also be re-started if new onset neovascularization is~     identified and is continued until the PDR is quiescent according to the treating~     investigator.~      Group 2 - Subjects will be seen every month, 28 days (+ 7 days), for 52 weeks. All subjects~     will receive IAI at baseline, after eligibility is confirmed. Week 4 through week 48,~     subjects will be seen monthly and treated with IAI PRN (pro re nata) according to, same day,~     CRC determination of DRSS initially, and subsequently of leakage index.~      Monthly treatment with IAI will continue until a greater than or equal to 2 step DRSS level~     improvement is achieved, relative to screening/baseline DRSS based on CRC assessment OPTOS~     fundus photos (FP). Subjects who have baseline proliferative diabetic retinopathy (PDR) (DRSS~     Level 61-71) will continue to receive monthly IAI until a greater than or equal to 2 step~     DRSS improvement is achieved as determined by CRC assessment of OPTOS fundus photos relative~     to screening/baseline DRSS, and PDR is quiescent according to the treating investigator.~      Leakage index as determined by CRC assessment of OPTOS wide field (WF) fluorescein~     angiography (FA) at the visit at which a greater than or equal to 2 step DRSS level~     improvement is achieved will be considered the threshold. Treatment with IAI will be~     reinitiated if the leakage index increases to 33% above the individual subject threshold~     leakage index level as determined by CRC evaluation of OPTOS WF-FA. If such worsening is~     detected, the subject would resume monthly IAI until the threshold leakage index as~     determined by CRC assessment of OPTOS WF-FA is reached. In addition, retreatment will also be~     re-started if new onset neovascularization is identified and is continued until the PDR is~     quiescent according to the treating investigator.~      If images of insufficient quality are unable to be obtained, in Group 1 or Group 2, subjects~     will undergo treatment with IAI at principal investigators discretion or designee.~      Subjects can have both eyes in the study, if eligibility is met. If both eyes are eligible,~     one eye will be randomized to group 1 while the other is randomized to group 2. If only one~     eye is eligible IAI will be provided for the fellow eye as needed according to the treating~     investigator.~   "
2717|NCT03531281|"~     This randomized pilot phase I trial studies the side effects of human lysozyme goat milk in~     treating patients with blood cancer undergoing a donor stem cell transplant. Sometimes the~     transplanted cells from a donor can make an immune response against the body's normal cells~     (called graft-versus-host disease). Giving human lysozyme goat milk to patients undergoing a~     donor stem cell transplant may stop this from happening.~   "
2718|NCT03531268|"~     In the perioperative realm, studies have demonstrated an association of genotype with~     efficacy of medications applicable to the surgical setting. A clinical association exists~     between the genotype of various genes and with opioid efficacy and toxicity - specifically~     for drugs such as oxycodone, codeine, morphine, fentanyl, and tramadol. More studies are~     needed to assess the effects of personalized dosing of analgesics during the perioperative~     process for various surgical procedures. The application of Pharmacogenomic testing (PGx) to~     perioperative medicine is novel, has much potential for growth and may potentially improve~     outcomes. However, successful implementation of a system to evaluate PGx and integrate~     results into clinical decision-making is challenging and has not been adequately assessed.~     The investigators propose to conduct PGx testing for patients undergoing surgery, evaluate~     its clinical utility, and assess outcomes. The investigators hypothesize that PGx testing may~     ultimately lead to a decrease in adverse events and improved outcomes in the perioperative~     period.~   "
2719|NCT03531255|"~     This is an Open Label, Non-Randomized, Multi-Center Extension Study for ongoing and planned~     Phase IB, Phase II, and Phase III studies with APL-2 in subjects with PNH.~   "
2720|NCT03531242|"~     The purpose of this study is to evaluate the safety and immunogenicity of VEE vaccine, C-84,~     TSI-GSD 205, Lot 7, Run 1, and collect data on the incidence of occupational VEE infection in~     vaccinated personnel.~   "
2721|NCT03531229|"~     The purpose of this study is to investigate safety, tolerability and pharmacokinetics of the~     drug Lu AF76432 given as single oral ascending doses to healthy young men~   "
2722|NCT03531216|"~     The objectives of this prospective crossover, open-label, nonrandomized study are to estimate~     effect sizes of vasodilatation and sense of warmth after application of topical rosemary~     essential oil in patients suffering from systemic sclerosis.~   "
2723|NCT03531203|"~     This study was a randomized controlled trial study. The aim of this study was to determine~     the effect of soursop fruit supplementation on blood pressure (BP), serum uric acid (SUA),~     and kidney function.~      The definition of prehypertension and hypertension was accepted as delivered in The Seventh~     Report of the Joint National Committee (JNC 7) as the systolic BP was 120 - 139 mmHg and~     diastolic BP was 80 - 89 mmHg for prehypertension, while systolic BP ≥ 140 mmHg or diastolic~     BP ≥ 90 mmHg for hypertension.~      Based on the study by Sja'bani (2014), the cut-off point of (SUA) was divided into 3~     categories, which are normal (< 5 mg/dL), high-normal (5 - <7 mg/dL), and high (≥ 7 mg/dL).~      A number of 143 people with essential prehypertension and high normal uric acid level were~     assigned as subject in this study. Subjects were randomly assigned into two groups which are~     treatment and control group. For a 3 months period, the treatment group was given 2x100 g~     soursop fruit juice per day and the control group was left without treatment.~      Blood pressure was measured by medical team using Omron HEM-907 (digital automatic blood~     pressure monitoring) every 2 weeks (3 times readings for each) in each subject's home.~     Subjects were examined in sitting position. Evaluation of laboratory examination was taken at~     week 0, 7 and 13.~   "
2724|NCT03531190|"~     The purpose of the project is to investigate the effect of wound healing of a combined pre-~     and postoperative oral supplement, consisting of zinc, vitamin C, arginine and multivitamin,~     as a supplement for adequate nutrition in patients operated for head and neck cancer.~   "
2725|NCT03531177|"~     The HEAL-D feasibility trial is a randomised control study to determine the feasibility of~     conducting an effectiveness trial of the Healthy Eating & Active Lifestyles for Diabetes~     programme; a culturally-tailored diet and lifestyle intervention for the management of type 2~     diabetes in African and Caribbean communities. In this feasibility study HEAL-D will be~     evaluated against usual care in 80 patients with type 2 diabetes. HEAL-D is a programme of~     culturally-tailored diabetes self-management education and support, delivered over 7~     sessions. Key outcomes are the acceptability of the programme; and recruitment and retention~     of the research participants. The current study will also pilot the feasibility and~     acceptability to participants of measuring proposed primary and secondary outcomes including~     HbA1c, blood lipids (triglyceride, total cholesterol, HDL-cholesterol, LDL-cholesterol), body~     weight, waist circumference, diabetes knowledge, diabetes and dietary competence, diabetes~     empowerment, perceived social support, quality of life, dietary intake, and physical~     activity.~   "
2749|NCT03530865|"~     A cross-sectional study to estimate Variations in the Number of Roots and the Root Canal~     System of the Permanent Mandibular First and Second Molars in a Sample of Egyptian Population~     using cone beam computed tomography through retrospective data analysis~   "
2768|NCT03530618|"~     The purpose of this study is to compare the differences in central venous catheter insertion~     time, success rate, and complication between the flexible tip straight guidewire and J-tip~     guidewire for ultrasound-guided central venous catheterization in small children.~   "
2726|NCT03531164|"~     One of the main objectives in spinal cord injury rehabilitation programs is the improvement~     of trunk control in order to achieve independence, to prevent complications and, in specific~     cases to walk.~      Research question: What is the effect of kayak ergometer training in trunk control,~     cardiovascular condition and independence in individuals with a spinal cord injury? Purpose:~     To determine the effect of kayak ergometer training in trunk control, cardiovascular~     condition and independence in individuals with a spinal cord injury.~      Methods: Randomized clinical trial, blinded to evaluator and to the person that will analyze~     data.~      Population: Spinal cord injured individuals treated at the National Institute of~     Rehabilitation, with a spinal cord injury of any ethiology, with a neurologic level of C8 and~     below, with time since injury from three months to one year.~      Proceeding: The subjects will be randomly assigned to : a control group with neuro~     propioceptive facilitation exercises focused in trunk control or an experimental group with~     kayak ergometer training. Both groups will recieve 5 sessions a week during 6 weeks.~   "
2727|NCT03531151|"~     Heart failure (HF) is an enormous health burden affecting approximately 5.1 million people in~     the US and is the cause of 250,000 deaths each year. Approximately 50% of HF is caused by~     myocardial ischemia and requires immediate restoration of coronary blood flow to the affected~     myocardium. However, the success of reperfusion is partly limited by intramyocardial~     hemorrhage, which is the deposition of intravascular material into the myocardium.~     Hemorrhagic reperfusion injury has high prevalence and patients have a much greater risk of~     adverse left ventricular remodeling, risk of fatal arrhythmia, impaired systolic function and~     are hospitalized at a greater rate. Recent magnetic resonance imaging techniques have~     improved assessment of reperfusion injury, however, the association between MRI contrasts and~     reperfusion injury is highly unclear, and lacks specificity to IMH. Improved imaging of IMH~     and accurate knowledge about its spatial and temporal evolution may be essential for delivery~     of optimal medical therapy in patients and critical to identify patients most at risk for~     adverse ventricular remodeling. The overall goal is to investigate the magnetic properties of~     hemorrhage and develop MRI techniques with improved specificity to hemorrhage. New MRI~     techniques permit noninvasive assessment of the magnetic susceptibility of tissues and can~     target tissue iron. Therefore, the investigators hypothesize that MRI imaging of myocardial~     magnetic susceptibility can map hemorrhagic myocardium. The investigators will perform a~     longitudinal observational study in patients after reperfusion injury to validate these~     methods, compare the methods with conventional MR contrasts and develop MR methods for~     imaging humans.~   "
2728|NCT03531138|"~     Lung transplantation candidates will be performed a 3-month hospital-based preoperative~     exercise training. A 6-minute walk test, a 10-meter walking speed test and a 5-times sit to~     stand test will be performed to determine the exercise capacity of the patient. The tests~     will be carried out at the beginning and end of rehabilitation. At each testing session, the~     tests will be performed sequentially by the same physiotherapist, giving 20 minute rest~     periods within the same day. It will be analyzed how the test data correlate with each other~     and how the delta values calculated for each test reflect the rehabilitation outcomes~     calculated after the exercise program.~   "
2729|NCT03531125|"~     Pancreatic cancer is a lethal disease. The 1-year and 5-year survival rate is approximately~     20% and <5% respectively.~      The treatment options available are limited. Only around 10-20% of patients present early~     enough to undergo surgical resection. Furthermore, chemotherapy for more advanced pancreatic~     cancer leads to limited survival benefit and can cause significant side effects. One of the~     main obstacles to developing new treatments for pancreatic cancer is the limited~     understanding of how pancreatic cancer cells change/evolve/adapt following treatment.~      This study is a pilot study to assess whether the investigators can track gene expression~     (using a technique called RNA sequencing) in pancreatic cancer cells between two separate~     time points. Investigators intend to take a tissue sample (biopsy) of the cancer using~     endoscopy ultrasound (EUS) and compare it with samples taken at the time of surgery in those~     patients with resectable disease. The interval between endoscopy and surgery will be~     approximately 2 to 3 weeks and reflects the standard period of time that patients wait from~     the time point at which the cancer is deemed to be operable (in the multi-disciplinary team~     meeting) to the actual operation.~      If the investigators find that the samples (biopsies) taken at EUS and surgery are comparable~     they plan to develop future clinical trials of similar design but with the addition of drug~     therapy. The investigators will use RNA sequencing to interrogate the effects of novel cancer~     drugs on gene expression within the tumour. This will give them information on how to select~     patients for therapy, how resistance develops to these treatments, and allow the~     investigators to better understand what treatments can be combined on a rational basis.~     However, prior to undertaking such studies it is important to understand how much variability~     there is in gene expression between sampling at 2 different time points at which two~     different techniques are used.~   "
2730|NCT03531112|"~     The purpose of the proposed study is to pilot a 6-month, cognitive-behavioral binge eating~     intervention, Appetite Awareness Training (AAT) to reduce binge eating and prevent weight~     gain for Black women with a BMI > 25 kg/m² and with weekly binge eating episodes.~     Intervention participants will receive a 8-week group AAT intervention, and will also receive~     bluetooth-connected scales for daily weighing. Participants will also receive tailored~     feedback on self-weighing frequency and weight change. We will follow-up with participants at~     six months.~   "
2731|NCT03531099|"~     The percentage of malignant prostate tumors detected very early is constantly increasing and~     the number of well differentiated tumors, with small volume and low risk of progression~     increases. When a tumor of this type is identified, radical prostatectomy remains the~     reference treatment, but this treatment is not without side effects. Active surveillance is a~     strategy which aims at detecting an early development of the cancerous disease in order to~     propose curative treatment in a timely manner and thus improve specific survival. Patients~     are therefore re-evaluated each year by rectal examination, PSA (Prostate-Specific Antigen)~     assay. Active surveillance remains difficult to manage psychologically for both the patient~     and the practitioner, because of the lack of treatment on the one hand and a rate of~     non-curable cancers close to 50% when signs of progression trigger a radical treatment.~      The aim of the focal treatment HIFU (High Intensity Focused Ultrasound) is to destroy the~     cancer without causing side effects in contrast to radical treatments. It is in this sense~     that it is positioned both as an alternative to radical surgery and as an alternative to~     active surveillance.~   "
2732|NCT03531086|"~     DaTscanTM Ioflupane I123, a radiopharmaceutical will be used as an adjunct diagnostic tool in~     combination with single photon emission computed tomography (SPECT) to evaluate striatal~     dopamine transporter (DAT) distribution in patients with idiopathic Parkinson's disease.~     Patients will be monitored twice - once at baseline, and again after 1 year - to identify~     potential biomarkers for progression of Parkinson's disease.~   "
2764|NCT03530670|"~     Compare the effects of pharmacological and nonpharmacological premedications on preoperative~     anxiety and mask acceptance after adenotonsillectomy~   "
2735|NCT03531047|"~     Young patients with keratoconus face two problems: disease progression and corneal shape~     irregularity. Both underlie the 20% rate of corneal transplantation in keratoconics required~     to maintain useful vision.~      Corneal collagen cross-linking (CXL) is a now the gold-standard treatment to halt disease~     progression. The aim is to strengthen the cornea to prevent further shape deterioration. For~     patients whose quality of vision has already suffered, standard CXL can generally only~     prevent further deterioration, rather than improving vision. Refractive CXL, a new iteration~     of CXL in which a bespoke treatment pattern is applied to the cornea, aims to smooth out~     surface irregularities thereby improving vision.~      This primary objective of this study is to compare the visual outcome in patients with~     progressive keratoconus treated with refractive CXL, as compared with historical controls~     treated with standard CXL.~   "
2736|NCT03531034|"~     This study evaluated the differences between normotensive and hypertensive menopausal women~     in ambulatory and blood pressure variability responses to combined aerobic and resistance~     exercise.~   "
2737|NCT03531021|"~     This study is evaluating how to encourage teens to engage in heart healthy behaviors such as~     being more active or eating in a healthy way. Teens will be randomly assigned to either the~     usual care group or the group with education, goal-setting, and lifestyle challenges with~     teammates.~   "
2738|NCT03531008|"~     The HEP2 study is designed to better understand the challenges of living with focal seizures~     that do not respond to medication, by following 200 people with medication-resistant focal~     epilepsy over two years to measure changes in health status, healthcare costs, quality of~     life, and biomarkers of epilepsy severity and treatment response.~   "
2739|NCT03530995|"~     This is a single centre, non-randomised, 4-period sequential dose study in healthy male~     subjects.~   "
2740|NCT03530982|"~     Adolescents with cerebral palsy (CP) present important limitations for the performance of~     daily living activities. The aims of the study is to evaluate the feasibility and effects of~     an intensive goal training protocol for adolescents with CP. He hypothesize that adolescents~     submitted to the studied protocol will present improvements in performance and satisfaction~     of prioritized functional goals.~   "
2741|NCT03530969|"~     The purpose of this study is to learn more about the effects of a training program designed~     to help doctors communicate better with older patients and their caregivers.~   "
2742|NCT03530956|"~     Background: Evaluating the use of a novel motorized ankle prosthesis during walking and under~     dual task circumstances is an important step in product development.~      Objective: To iteratively evaluate the effectiveness of a novel bionic foot, the Ankle~     Mimicking Prosthetic device 4+ (or AMPfoot 4+), during walking.~      Study design: Case study (crossover) research design.~      Methods: One male subject will conduct a baseline experimental trial with the current~     prosthetic device and several experimental trials with the AMPfoot 4+ to evaluate the~     effectiveness of the novel device and investigate the adaptation period. Prior to baseline~     experiments, a familiarization trial will be performed to determine intra-subject variability~     of the dual task. An experimental trial consists of 2 walking tasks, i.e. the 6-minute walk~     test (6MWT) and the 10-meter walk test. The 6MWT will be combined with a cognitive task, i.e.~     backwards counting, to create dual task circumstances. The outcome measurements for the dual~     task are the distance covered and the walking speed, heart rate (HR) (Polar), rating of~     perceived exertion (RPE), VO2 (Cosmed K5), electro-encephalography (EEG), electro-myography~     (EMG), electro-cardiography (ECG), electrodermal activity (/skin conductance),accuracy and~     total duration of the cognitive task, BodyMedia (physical activity) and the visual analogue~     scale (VAS) for fatigue and comfort. A 10-meter walk test will be evaluated on duration.~      Expected findings: In a first phase the novel device will probably reduce walking and~     cognitive performance, whereas fine-tuning the mechatronics (after several retests) should~     improve walking and cognitive performance during walking.~   "
2743|NCT03530943|"~     The current study utilized a randomized controlled trial, conducted in a real-life setting,~     to determine whether, how, under which conditions, and for whom, infusing various levels of~     human-animal interaction (HAI) in a 4-week, university-based stress prevention program~     provides an effective approach to prevent negative ramifications of university students~     stress, promote student executive functioning and learning, while safeguarding animal~     welfare. This study will examine effects of sole exposure to evidence-based stress prevention~     content, hands-on HAI with registered PET Partner teams, or combinations thereof on students'~     moment-to-moment well-being and longer-term functioning in socioemotional, cognitive and~     physiological domains.This study will also develop a comprehensive coding system and measure~     the dynamic nature of behavior of participants, handlers and animals during university- based~     animal assisted activities, as well as the HAI environment. The data and analyses will then~     be utilized to inform the development of a quantitative measure to capture of the quality of~     human animal interaction in various settings to experimentally determine causal pathways~     underlying program effects on humans and animals.~   "
2744|NCT03530930|"~     The study evaluates analgesic, antiinflammatory and metabolic effects of Comarum palustre in~     patients with knee osteoarthritis (OA) and diabetes mellitus. Patients with osteoarthritis~     will receive Comarum palustre together with conventional treatment of osteoarthritis and~     diabetes.~   "
2745|NCT03530917|"~     To evaluate safety and tolerability of single and multiple ascending doses of oral RO7020531~     in Chinese healthy participants~   "
2746|NCT03530904|"~     Mobilization after cardiac implantable electronic devices (CIED) implantation is highly~     variable between centers, some discharging home after 3-4 hours while others request bed~     restriction for 24 hours. Concern about lead dislodgements due to early mobilization are~     probably not justified. Bed restriction may result in considerable inconvenience to the~     patients.~   "
2747|NCT03530891|"~     Comparison between computer guided lag screw fixation versus traditional lag screw fixation~     in open reduction and internal fixation of anterior mandibular fractures.~   "
2765|NCT03530657|"~     This national multicenter prospective study is aimed to study the diagnositic performance of~     STE/STQ elastography in liver fibrosis and prognosis in patients with chronic hepatitis B~     infection.~   "
2766|NCT03530644|"~     This clinical study has been launched to compare the performances of two models of a~     non-invasive glucose monitoring device.~   "
2816|NCT03529994|"~     The purpose of this study is to compare work of breathing on different levels of high flow~     respiratory support on infants born between 27 and 37 weeks gestation.~   "
2750|NCT03530852|"~     Children with inadequate intestinal absorption due to loss of large amounts of small bowel~     require intravenous nutrition (feeding through the vein) to sustain hydration and nutrition~     to avoid starvation and dehydration; however, intravenous (IV) nutrition can lead to~     complications including liver failure. Tube feeding directly to the small intestine avoids~     the complications of IV nutrition, but fats are not fully digestible due to inadequate bowel~     function. We propose to predigest the fat using a small cartridge attached to the feeding~     tube to allow for rapid absorption with the possibility of reducing or eliminating the need~     for intravenous nutrition~   "
2751|NCT03530839|"~     Background: The aim of this study was to compare operative outcomes after lesser toe~     deformity correction with either proximal interphalangeal (PIP) joint arthrodesis or PIP~     joint resection arthroplasty.~      Methods: A prospective randomized controlled trial was performed on 37 patients (48 toes) who~     underwent one of these two procedures. The Numeric Rating Scale (NRS) for pain, American~     Orthopaedic Foot and Ankle Society (AOFAS) score, osseous consolidation, and clinical outcome~     were evaluated preoperatively and at 6 weeks and 6 months postoperatively.~   "
2752|NCT03530826|"~     All4Cure aims to accelerate learning about cancer by sharing medical information and research~     results from cancer patients with fellow cancer patients, oncologists, and scientists on the~     All4Cure website with the hope that together patients, clinicians and researchers can cure~     cancer faster.~   "
2753|NCT03530813|"~     The Asthma First Aid Management for School Staff eBook has been developed for the purpose of~     providing a multimedia self-directed training resource for school staff. The eBook will be~     accessible to both primary and secondary school staff; it has the advantage over conventional~     face to face training in that it can be used for learning when convenient, regardless of~     geographical location. The eBook has been designed to provide school staff with an~     alternative training option in contrast to a structured time scheduled face to face asthma~     first aid management training session. The content of the eBook is based on the information~     from the current Sydney Children's Hospital, Aiming for Asthma Improvement in Children~     School Champion Asthma Management Program (SCAMP) face to face training course.~      This study has been designed to determine the effectiveness of the eBook in meeting the~     asthma first aid management training needs of school staff, prior to its implementation and~     uploading to the Apple iBook store where it will be freely available to school staff~     internationally.~      The study will involve school staff being randomized into one of the following two training~     groups:~      Group 1 - a three hour face to face School Champion Asthma Management Program training~     session (Standard training; control group) Group 2 - completion of the self-directed Asthma~     First Aid Management for School Staff eBook (Technology assisted learning) The school staff~     will be required to complete pre and post training validated asthma knowledge questionnaires~     which will measure improvements in knowledge and confidence. In addition, demographic data~     will be collected.~      The researchers hypothesize that the eBook will provide school staff with an alternative mode~     of training that will effectively increase school staff asthma management knowledge and~     confidence. We aim to investigate if this training is superior to the current three hour face~     to face School Champion Asthma Management Program training.~   "
2754|NCT03530800|"~     The goal of the proposed study is to evaluate the efficacy and safety of dronabinol in~     trichotillomania. 50 subjects with DSM-5 trichotillomania will receive 6 weeks of~     double-blind dronabinol or placebo. The hypothesis to be tested is that dronabinol will be~     effective and well tolerated in patients with trichotillomania compared to placebo. The~     proposed study will provide needed data on the treatment of a disabling disorder that~     currently lacks a clearly effective treatment.~   "
2755|NCT03530787|"~     Cosmeceuticals are an emerging market within dermatology and the growth of natural products~     and derivatives of natural products has accelerated in use within the field. Here the~     investigators aimed to study the microbial and cosmetic effects of Synoxyl AZ, the trade name~     for topical acetyl zingerone (AZ), a novel compound designed based on Zingerone and curcumin.~   "
2756|NCT03530774|"~     Older adults are at risk for developing sarcopenia, or age-related muscle loss, which~     increased the risk of disabilities, falls, and loss of independence. Many older adults do not~     consume enough protein each day to maintain their muscle mass and this study aims to~     investigate if consumption daily egg white protein supplement can help maintain muscle mass~     and functionality in community-dwelling older adults. Food insecure older adults that attend~     congregate nutrition sites will be targeted.~   "
2757|NCT03530761|"~     The aim of this study is to investigate i) whether two biomarkers (urine NAG, urinary~     cystatin C) could be predictive factor in patient with liver cirrhosis, , and ii) whether~     these biomarkers can predict response of terlipressin.~   "
2758|NCT03530748|"~     1. Evaluate the feasibility for the on-table evaluation of the renal perfusion by using~          Syngo Dyna Parenchymal Blood Volume(PBV) Body;~        2. Explore the clinical benefits of this application during procedure to help the physician~          to determine the procedure endpoint.~   "
2759|NCT03530735|"~     This is a feasibility study that will assess the efficacy of using autologous blood to treat~     moderate to severe dry mouth. Dry mouth has been estimated to affect up to 64.8% of the~     general population (Navazesh et al., 2009) and many patients that are affected by Sjögren's~     syndrome or have had radiation therapy to combat head or neck cancer (Navazesh et al., 2009).~      The blood will be applied to the interior of the mouth by means of a mouthwash. This research~     poses the first potential curative treatment for dry mouth - all other current dry mouth~     treatments are either symptomatic or lifestyle-based.~      Autologous blood has been shown to be effective in treating the epithelial surface of dry~     eyes. This has been attributed to the analogous growth factors in the blood to that of tears~     - and potentially in this case, saliva - in healing the oral epithelial surface (Herbst et~     al., 2004).~   "
2760|NCT03530722|"~     Fresh breast core biopsies suspicious for breast cancer that are usually taken during~     clinical breast assessments will be imaged via confocal microscopy.~      The device so called HistologTM Scanner is based on confocal fluorescence and displays~     microscopic histology images superficial layers of fresh tissue.~      After the imaging procedure the fresh breast tissue specimen will be followed according to~     the gold standard workflow (H&E-stained images).~      Subsequently, two pathologists will analyze the HistologTM Scanner obtained-images and~     H&E-stained images for potential breast cancer structures.~      A comparison of both analyses for cancer visualization will be performed to evaluate the~     feasibility of using confocal microscopy for breast cancer detection.~   "
2761|NCT03530709|"~     This is a pilot trial to test whether tertiary center-affiliated pediatricians with expertise~     in medical complexity joining medical visits with patients' community primary care providers~     is feasible and acceptable. We will also collect data on a range of patient-centered and~     utilization outcomes to determine effect compared to usual care.~   "
2762|NCT03530696|"~     This is a randomized phase II study to evaluate if the combination of T-DM1 with palbociclib~     improves progression-free survival compared to single agent T-DM1in patients with metastatic~     HER2 positive breast cancer~   "
2763|NCT03530683|"~     Multicenter, open-label, phase 1a/1b Dose Escalation and Expansion Trial of TTI-622 in~     Patients with Advanced Relapsed or Refractory Lymphoma or Myeloma.~   "
2769|NCT03530605|"~     This study will compare the overall survival (OS) time of elderly patients who would not~     tolerate standard chemotherapy for PCNSL treated with WBXRT together with Optune-TTF to those~     treated with whole-brain radiotherapy alone.~      Standard treatment of primary central nervous system lymphoma (PCNSL) for patients with good~     performance status involves high-dose methotrexate-based chemotherapy regimens and~     whole-brain radiation therapy (WBXRT). Although up to 20% of patients with PCNSL are 80 years~     of age or older, little data exist with regard to optimal treatment of this patient~     population and they often do not qualify for clinical trials. In addition, elderly patients~     have a poorer rate of complete and partial response and increased risk of toxicity when~     treated with standard chemotherapy regimens. Though a consensus does not exist, radiotherapy~     alone is often used in these patients to minimize toxic effects of more aggressive~     chemotherapies.~      The Optune TTF device has proven effective in treating high-grade gliomas and is currently~     being investigated to treat meningiomas and metastatic lesions in the brain as well as other~     tumor types elsewhere in the body. It is generally well tolerated with no known systemic side~     effects, producing only an occasional local skin reaction. The mechanism of action is~     independent of tumor type and therefore may be effective in treating lymphoma as well.~   "
2770|NCT03530592|"~     The purpose of this research study is to test the utility of an ankle robot in people with~     ankle weakness and foot drop from a peripheral nervous system injury due to neuromuscular or~     orthopedic injury.~   "
2771|NCT03530579|"~     The primary goal of this study is to develop, implement, and test a community health worker~     (CHW) program designed to promote diabetes prevention among Korean and South Asian Americans~     in New York City.~      In particular, the specific aims of this study are:~        1. To utilize community based participatory research (CBPR) methods to expand upon an~          existing campus-community partnership to develop and implement a CHW program among~          Korean and South Asian Americans that promotes diabetes prevention;~        2. To develop, implement, and assess the efficacy of a CHW intervention to promote diabetes~          prevention and access to care among NYC Koreans and South Asians.~   "
2772|NCT03530566|"~     Prospective multicenter observational clinical study on a dietary regimen in obese patients~     scheduled for bariatric surgery.~   "
2773|NCT03530553|"~     In this study, we plan to determine the efficacy of the Hunt Motivational Scale as a tool for~     weight loss compared to standard of care in the Penn Medicine Princeton Health weight~     management program.~   "
2774|NCT03530540|"~     Aim The primary aim is to examine whether LI-ESWT and vacuum erectile device (VED) followed~     by manipulation exercises has beneficial effect on PD patients compared to a placebo group.~      Primary Outcome~        -  Peyronie's Disease Questionnaire (PDQ)~        -  Visual Analogue Scale score (VAS)~        -  International Index of Erectile Function 5 (IEFF-5)~        -  Penile curve measurements (gold standard) on pictures before and after treatment~        -  Plaque size~      Method This study is designed as a prospective, randomized, double-blinded,~     placebo-controlled with follow-up after 1, 3 and 6 months.~      A total of 50 participants who meets the inclusion criteria's will randomly be assigned to~     I(intervention) or C(control) group based on a randomization list which is retained in a~     sealed envelope. The content of the envelope is only familiar to the Head of the Department~     of Urology to ensure valid randomization.~      All treatment sessions are executed at the outpatient clinic of the department of urology~     department L at Odense University Hospital(OUH). All patients receive treatment with the same~     device a Duolith® SD1 T-Top from Storz Medical. However, when treating patients in the~     control group the handpiece will be covered by a shockwave absorbent material. Settings and~     setup are identical in both groups to make sure that patients are unable to acknowledge which~     treatment is being performed.~   "
2775|NCT03530527|"~     Biliary drainage is the mainstay of the palliative treatment in patients with inoperable~     malignant bile duct stricture. Endoscopic retrograde cholangiopancreatography (ERCP) is the~     cornerstone of biliary drainage method in these patients. However, ERCP is sometime~     unsuccessful to perform because of the presence of the high grade biliary stricture, tumor~     invasion of duodenum and ampulla of vater and surgically altered gastrointestinal anatomy.~     Endoscopic ultrasound (EUS) guided biliary drainage has been emerged as an alternative~     procedure to traditional surgical bypass and percutaneous trans hepatic biliary drainage~     after failed ERCP. There were few data to directly compare between ERCP and EUS guided~     biliary drainage and in patients with malignant high grade biliary stricture.~   "
2776|NCT03530514|"~     The primary objective of the study is to evaluate the safety and tolerability of REGN4461 in~     healthy subjects. The secondary objectives of the study are to:~        -  Characterize the Pharmacokinetic (PK) profile of single and repeated doses of REGN4461~        -  Estimate the effects of repeated doses of REGN4461 on body weight~        -  Assess the effects of repeated doses of REGN4461 on ad lib energy intake in overweight~          and obese subjects~        -  Evaluate the effects of single and repeated doses of REGN4461 on soluble forms of~          lipid-regulating proteins levels over time~        -  Assess the immunogenicity of single and repeated doses of REGN4461~   "
2777|NCT03530501|"~     The present study aimed to investigate the changes produced in gut microbiota by a~     very-low-calorie-ketogenic diet followed by a low calorie diet, whether the use of synbiotics~     is able to modulate gut microbiota diversity and composition and its association with gut~     permeability and inflammation~   "
2778|NCT03530488|"~     women candidate for office hystroscopy were randomized to either flushing of the endocervix~     and endometrium with 4 ml lidocaine 2% diluted in 15 ml normal saline or 19 ml normal saline~     before office hystroscopy~   "
2779|NCT03530475|"~     This study will be conducted on (100) pregnant women diagnosed as placenta previa by~     ultrasonography and are candidates for either emergency or elective repeated cesarean section~     or hysterectomy (if the diagnosis of placenta accreta is confirmed).~      All of those patients are presenting during the period of may 2018 to july 2018 to Kasr-Al~     Ainy Obstetrics outpatient clinic or casualty department during their 3rd trimester.~      All of them will be assorted according to certain inclusion and exclusion criterions as~     follow:~   "
2841|NCT03529669|"~     This is a feasibility study testing the use of the Cytosponge™ device in patients with known~     oesophageal cancer treated with pre‐operative or definitive chemoradiation. All participants~     will receive one Cytosponge™ procedure at one time‐point within 4‐16 weeks after completion~     of chemoradiotherapy.~   "
2780|NCT03530462|"~     Most of patients with autoimmune encephalitis are left with permanent cognitive deficits of~     varying severity. The patients' life and career would be affected definitely by cognitive~     deficits. Recently, more and more clinical physician have begun to focus on cognitive~     impairment of patients with autoimmune encephalitis. Generally, the outcome was measured by~     the modified Rankin Scale (mRS). However, the mRS are commonly used to evaluate the degree of~     disability or dependence in the daily activities of the patients suffering from a stroke and~     cognition function were minimally evaluated in this scale. It is crucial to adopt detailed~     cognition tools to study the long-term cognitive outcomes and as an indicator of overall~     curative effect judgment in autoimmune encephalitis.~      Currently, only early immunotherapy is uniformly and consistently considered to produce~     favorable cognitive outcomes. However, studies concerning the association of second-line~     immunotherapy with cognitive outcomes have been scarce and have shown conflicting results~     regarding autoimmune encephalitis.~      Hence, the goal of this study was to explore cognitive neural mechanism of autoimmune~     encephalitis by using neuropsychological tests and multi-mode MRIs.~   "
2781|NCT03530449|"~     Repeatability and Reproducibility of OCTA Image Quality with the Heidelberg Engineering~     SPECTRALIS~   "
2782|NCT03530436|"~     The curcuminoids curcumin, demethoxycurcumin and bisdemethoxycurcumin can be found in the~     rhizome of turmeric (Curcuma longa). Curcumin is widespread used for colouring foods. Based~     on its natural low bioavailability and the number of its effects on human health, several~     approaches such as increasing its water solubility or inhibiting its metabolism were taken to~     improve its bioavailability. Pharmacokinetics of curcumin from various supplements using~     those different mechanisms have been compared to the one of native curcumin. The~     investigator's study here will compare the bioavailability of curcumin from eight different~     curcumin formulations with native curcumin and between themselves. The study will folllow a~     single dose (in form of curcumin formulations, normalized to 240 mg curcumin),~     placebo-controlled, randomized, double-blind, nine-armed crossover study design with ≥ 1-week~     washout periods. Plasma samples will be collected at intervals up to 24 hours after intake.~     Investigators will compare the pharmacokinetics between the different curcumin formulations~     and to native curcumin.~   "
2783|NCT03530423|"~     The purpose of this trial is to determine if implantable cardiac device leads implanted in~     the His bundle are capable of detecting ventricular arrhythmias.~   "
2784|NCT03530410|"~     The study aims to measure the effect of intragastric balloon on gastric function,~     particularly gastric accommodation and pace making, and the possible underlying changes in~     autonomic function~   "
2785|NCT03530397|"~     The purpose of this study is to evaluate MEDI5752 in adult subjects with advanced solid~     tumors, when administered as a single agent or combined with chemotherapy.~   "
2786|NCT03530384|"~     More and more studies aim to improve neurocognitive functioning in alcohol use disorder, but~     very few studies have focused on training-inhibitory-control efficacy on alcohol intake. Our~     program relies on a comprehensive model of addiction considering inhibition deficit as the~     hallmark of addiction. Our program proposes inhibition training on a task which does not~     refer to alcohol, combined with a debriefing promoting transferability of the enhanced skill~     and psychoeducation. In this perspective of aiming to retrain deficits involved in addiction~     in itself and not only due to alcohol toxicity. We propose an add-on single-blinded~     randomized controlled trial, in alcohol use disorder, assessing the efficacy of a~     computerized cognitive training program targeting inhibition as compared to treatment as~     usual.~   "
2787|NCT03530371|"~     Auditory brainstem response testing is necessary in children who are not able to be tested by~     classical audiogram, because of their age or an associated retarded psycho-motor development~     or behavioral and cognitive troubles.~      This test needs a perfect immobility of the child, ideally being asleep. This situation is~     sometimes impossible to achieve in non-cooperative children.~      Currently, in the Pediatric Hospital of Nice, the investigators have to do a general~     anesthesia to perform quality auditory response tests in this kind of patients.~      The alternative to a general anesthesia would be a reliable sedative drug, allowing the~     performance of this diagnostic exam without the need of a hospitalization.~      Dexmedetomidine is a sedative drug with an action on the α2 adrenergic receptors. It causes a~     rapid sedation, similar to the natural sleep and with minimal secondary effects. The~     possibility of an intranasal administration, avoids the pain and discomfort of a venous~     access insertion.~   "
2788|NCT03530358|"~     For this project the investigators ask, how the activation and organization of muscle~     synergies may be disrupted by brain lesions, and whether it is possible to modify synergy~     activations by means of specific therapies. Will be investigated whether there is a~     relationship between post-stroke cortical plasticity and changes in synergy activations due~     to a therapy.~   "
2789|NCT03530345|"~     The aim of this trial is to investigate the efficacy and safety of intravenous neridronic~     acid in subjects with Complex Regional Pain Syndrome (CRPS).~      The trial consists of an Enrollment Period lasting up to 60 days, Treatment Period A~     consisting of 4 infusions (neridronic acid or placebo) over 10 days, and a Follow-up Period 1~     until Week 26.~      At Week 26, participants not meeting the pre-specified criteria to continue into Treatment~     Period B will continue in Follow-up Period 2 until Week 52. Participants meeting the~     pre-specified criteria will enter the open-label Treatment Period B with 4 additional~     infusions (neridronic acid) over 10 days and follow-up visits until Week 52.~   "
2790|NCT03530332|"~     This research study is being done to find out whether a screening blood test can help~     identify women with an increased risk of preterm birth.~   "
2791|NCT03530319|"~     A randomized clinical trial comparing treatment effectiveness of azithromycin and doxycycline~     for pediatric Mycoplasma pneumonia.~   "
2792|NCT03530306|"~     This is a four arm, patient subtyping and parameter optimisation study for a neuromodulation~     treatment for tinnitus.~   "
2793|NCT03530293|"~     This is a Phase 2, double-blind, placebo-controlled, randomized withdrawal study to evaluate~     the safety and maintenance of efficacy of an optimized once-daily (qd) dose of NBI-98854 in~     pediatric subjects with TS.~   "
2794|NCT03530280|"~     knee arthroscopy under spinal anesthesia were included in this study.~   "
2795|NCT03530267|"~     This is a controlled, open-label, randomized phase- II trial (1:1 randomization)~     investigating 5-FU + aflibercept and 5-FU + oxaliplatin in elderly and frail elderly patients~     with mCRC scheduled to receive first line treatment.~   "
2796|NCT03530254|"~     Patients who have shown previous implantation failures, despite transferring good quality and~     chromosomally normal embryos (diagnosed by PGT-A), could have a displaced Window of~     Implantation (WOI) and consequently, alterations in their endometrial receptivity. The~     correction of this displacement can improve the results of the Assisted Reproduction~     Treatments (ART).~      The ERA test (Endometrial Receptivity Analysis) evaluates the transcriptomic endometrial~     profile to determine if the patient's uterus is receptive when the embryo is transferred~     during an In Vitro Fertilization (IVF) process, and identifies the personalized WOI of the~     patient. This process is called Personalized Embryo Transfer (pET).~      The Preimplantation Genetic Test of Aneuploidies or PGT-A (Preimplantation Genetic Testing~     for Aneuploidy), is currently carried out using Next Generation Sequencing (NGS) and serves~     to identify chromosomally normal embryos prior to their transfer in an IVF treatment.~     Aneuploidies are rarely compatible with life or can cause congenital diseases. So, the~     identification of chromosomally normal embryos, improves the success of reproduction in cases~     in which infertility is caused by such aneuploidies.~      Therefore, the aim of this study is to determine, in a randomized and prospective way, the~     clinical benefit of adding the ERA test to the embryonic aneuploidies test for patients with~     a PGT-A indication.~   "
2797|NCT03530241|"~     Background. X-ray cholangiography has a high sensitivity and specificity of detecting bile~     duct stones and is the gold standard. There are no studies describing the sensitivity and~     specificity of IFC for bile duct stone detection.~      Research question. What is the sensitivity of IFC to visualize bile duct stones? Method.~     Prospective study with 40 patients undergoing planned laparoscopic cholecystectomy with~     preoperative magnetic resonance cholangiopancreatography (MRCP) (gold standard) and~     intraoperative IFC, X-ray cholangiography and choledochuscopy in that order.~      Primary outcome. Sensitivity of visualization of bile duct stone by fluorescent~     cholangiography and secondary outcome is visualization of anatomy.~   "
2798|NCT03530228|"~     A randomized, open-label, active-controlled, single/multiple-dose phase 1 clinical trial to~     evaluate pharmacokinetics/pharmacodynamics and safety/tolerability of tegoprazan after oral~     administration in healthy male subjects~   "
2799|NCT03530215|"~     Antineoplastic and immunomodulating agents may lead to various cardio-vascular adverse~     reactions. This study investigates reports of cardio-vascular toxicities for treatment~     including Anatomical Therapeutic Chemical (ATC) classification L (antineoplastic agents,~     endocrine therapy, immunostimulants, and immunosuppressants drugs) in the World Health~     Organization's (WHO) global database of individual safety case reports (VigiBase).~   "
2800|NCT03530202|"~     The age-related loss of skeletal muscle mass (i.e. sarcopenia)and muscle performance (i.e.~     strength and power), decreases functionality and the ability to perform activities of daily~     living. Therefore, lifestyle interventions which may improve aging muscle health are~     important (i.e. resistance training and creatine supplementation). High-velocity resistance~     training (HVRT) has been shown to increase muscle mass and muscle performance in aging~     adults. Creatine (CR), a compound naturally found in red meat and seafood, has also been~     shown to increase muscle mass and muscle performance in aging adults. No study has examined~     the combined effects of HVRT and CR supplementation in aging adults. This study may determine~     whether this lifestyle intervention is effective to combat sarcopenia.~   "
2801|NCT03530189|"~     The hypothesis of this prospective, cohort study is that hyperglycemia, hypoglycemia and~     unstable glucose levels in the first seven days of life in infants born very preterm and at~     very low birth weights can harm long-term neurodevelopment. The objective of the study is to~     investigate the relationship between early neonatal glycemia, neonatal characteristics, and~     developmental outcomes in preterm infants. All infants born before 32. gestational week or~     below 1500 g admitted to the neonatal intensive care unit will be included in the study.~     According to the glucose values, the infants will be divided into the normoglycemic group and~     the group with disturbed glucose concentration. In the corrected age of two~     neurodevelopmental outcome will be assessed and categorized as normal, mild, moderate or~     severe impairment. Since the results of published studies about the effects of asymptomatic~     neonatal hypoglycemia and hyperglycemia on neurodevelopment are inconsistent, the correlation~     between early disturbances in glucose levels and neurodevelopmental outcome will be assessed.~   "
2802|NCT03530176|"~     Coronary artery calcification is a sign of heart disease. A nuclear medicine PET-CT test~     using sodium fluoride (18F-NaF) radioisotope has been shown to help identify growing~     calcification plaques early on in the disease process. It is known that diabetic patients are~     at a high risk of developing premature coronary disease; the investigators intend to use this~     new technology to identify those patients at higher risk of developing coronary artery~     disease.~   "
2803|NCT03530163|"~     Individuals traveling to altitudes above 8,000 feet may suffer from impaired exercise and~     cognitive performance, and acute mountain sickness (AMS). Decreased barometric pressure,~     which leads to low blood oxygen levels, is the primary cause of these disorders. Symptoms of~     AMS are characterized by headache, nausea, vomiting, dizziness, fatigue, and difficulty~     sleeping. The goal of this research is to identify whether Respiratory Muscle Training will~     improve physical and cognitive performance, and reduce the symptoms of AMS, at simulated high~     altitude.~   "
2804|NCT03530150|"~     Burn patients which skin has been lost a rapid growth of the skin is a foremost in their~     treatment. Due to the injury, burn patients undergo a systemic inflammation that helps the~     skin heal faster. However, several studies have shown that this inflammation increases the~     levels of several inflammatory molecules that impairs skin growing, which further delays the~     recovery of burn patients. As such, by inhibiting these inflammatory molecules with the~     administration of a medication called pirfenidone burn patients might present faster rates of~     skin growth and recovery. Thus, patients suffering from a burn injury will be recruited at~     the emergency department of the Hospital University in Monterrey Mexico. Afterward, patients~     will be randomized to either receive pirfenidone 600 mg orally once per day or usual care~     consisting of covering the wound with hydrocolloid dressings. To assess the amount of newly~     growth skin investigators will take a small piece of the skin to further evaluate it through~     a microscope.~   "
2842|NCT03529656|"~     The purpose of this study is to determine whether an early rehabilitation program for~     immediate liver transplant patients is safe and effective in preventing critical care illness~     and intensive care unit acquired weakness.~   "
2805|NCT03530137|"~     The purpose of this study is to help us learn what are the best services to promote young~     children's healthy development for families who are experiencing homelessness. Participants~     may participate in three programs: 1. Healthy Home: four weekly, one-hour group sessions on~     health topics; 2. Attachment and Biobehavioral Catch-up (ABC): 10, one-hour parenting with~     parent and child; 3. Healthy Steps: helps families identify, understand and manage parenting~     challenges completed at well child visits. Participants will be asked to complete surveys,~     participate in focus groups, and interviews about the experiences with the services offered.~     Questionnaires about understanding health issues and surveys about parenting behaviors and~     self-efficacy will also be completed. Study duration is approximately 10 - 12 weeks. Programs~     may be continued once families move into permanent housing.~   "
2806|NCT03530124|"~     A prospective, randomized open-label clinical trial will be conducted from July 2018 to~     October 2020. Approximately 300 preterm infants will be enrolled across three sites: Duke~     University Medical Center, the University of North Carolina, and Cincinnati Children's~     Hospital Medical Center. Eligible infants will be randomized 1:1 to receive either 2-month US~     licensed childhood vaccines (PCV13, DTaP, HBV, IPV an Hib) or no vaccines. After their~     participation in the study, healthcare providers of the infants in the unvaccinated group~     will make decision abut receipt of their 2-month childhood vaccines. The study will collect~     data from the continuous cardiorespiratory and pulse oximetry monitors from randomization to~     48 hours after randomization for infants in the unvaccinated group, and from randomization to~     48 hours after vaccination for infants in the vaccinated group. Infants in both groups will~     be monitored for up to 60 hours for the occurrence of apnea, bradycardia, and oxygen~     desaturation. For infants in the vaccinated group, the study will also collect adverse~     events of clinical interest and serious adverse events occurring between the end of the~     48-hour monitoring period and 14 days after vaccination. This information will be collected~     through parental report and review of medical records.~   "
2807|NCT03530111|"~     A method has been developed to measure in vivo adipose kinetics and turnover rates, which is~     a substantive departure from previous indirect and in vitro approaches. This technique~     involves drinking deuterium (2H)-labeled water, with an initial ramp-up to increase body~     water 2H enrichment, followed by daily intake to maintain enrichment values. The 2H from the~     heavy water is incorporated into the DNA of the dividing cells, as well as the lipid~     component, providing measures of cell formation, lipid synthesis, and adipose turnover. The~     objective of the proposed study is to enroll women who are overweight (sedentary or~     physically active) in order to collect 2H-enriched adipose tissue specimens that will be~     utilized to establish this innovative 2H-labeling protocol at Pennington Biomedical Research~     Center. This study will also assess adipose kinetics in individuals with different levels of~     physical activity to better understand the association between in vivo adipose cell kinetics,~     physical activity, and metabolic health in humans.~   "
2808|NCT03530098|"~     The purpose of this study is to understand the effects of using a Artificial Intelligence~     algorithm for skeletal age estimation as a computer-aided diagnosis (CADx) system. In this~     prospective real-time study, the investigators will send de-identified hand radiographs to~     the Artificial Intelligence algorithm and surface the output of this algorithm to the~     radiologist, who will incorporate this information with their normal workflows to make a~     diagnosis of the patient's bone age. All radiologists involved in the study will be trained~     to recognize the surfaced prediction to be the output of the Artificial Intelligence~     algorithm. The radiologists' diagnosis will be final and considered independent to the output~     of the algorithm.~   "
2809|NCT03530085|"~     Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is reported to be able to~     improve the outcomes for elderly acute myeloid leukemia (AML) in complete remission (CR). At~     present, the best conditioning regimen for elderly AML in CR remains in discussion. In this~     prospective study, the safety and efficacy of Dec+Flu+Bu myeloablative conditioning regimens~     in patients with elderly AML in CR undergoing allo-HSCT are evaluated.~   "
2810|NCT03530072|"~     Febrile neutropenia is a common complication in pediatric oncology patients. Standard of care~     requires admission of all patients for intravenous antibiotics until cultures are negative,~     patients are afebrile and there are signs of bone marrow recovery. This often results in~     prolonged hospital admissions with significant financial costs, decreased quality of life and~     potential secondary infections. More recent data suggests it may be possible to identify a~     low risk group that can be discharged prior to signs of bone marrow recovery. At this time,~     researchers have been unable to identify a model that is safe for early discharge across~     institutions.~   "
2811|NCT03530059|"~     This study is a prospective observational study which aim to evaluate the feasibility of a~     total and systematic home respiratory rehabilitation training program in patients who will~     undergo thoracic surgery, and otherwise tend to define failure reasons.~   "
2812|NCT03530046|"~     This is a research to study primarily the effect of rapidly infused high strong ion~     difference (SID) fluid vs Hartmann's solution in altering the pH and bicarbonate level of the~     patient, who is in sepsis with metabolic acidosis. Half of the study population gets high SID~     fluid, while the other half will get Hartmann's solution.~   "
2813|NCT03530033|"~     In recent years, the application of intraoperative recurrent laryngeal nerve monitoring in~     thyroid surgery has greatly reduced the complications of recurrent laryngeal nerve injury.~     The use of intraoperative neurological monitoring requires the reduction of the dose of~     neuromuscular blockade, which often leads to muscle tremors during the application of~     electrical energy, which affects the fine separation around the muscles. This study explored~     the effect of local application of lidocaine on reducing muscle tremor during surgery and its~     optimal dose.~   "
2814|NCT03530020|"~     The aim of the present study is to evaluate the wear characteristics and clinical performance~     of lithium silicate crowns in comparison to monolithic zirconia crowns.~      The quality of the overall restorations as well as gingival tissues will be also evaluated~     according to modified United States Public Health Service (USPHS) criteria: (Marginal~     adaptation, color match, anatomic form, integrity of restoration, secondary caries,~     retention, tooth sensitivity, gingival index and periodontal index) at baseline, 6 months and~     1 year~   "
2815|NCT03530007|"~     Shivering is one of the most frequent complications occurring during or after spinal~     anesthesia with many side effects. The aim of the present study was to compare between two~     different doses of ondansetron for anti-shivering effect~   "
2817|NCT03529981|"~     Prior research in Dr. Siegle's lab has shown a novel intervention Tuned Vibroacoustic~     Stimulation (TVS), can have a calming and positive effect. Here, the investigators will~     continue to evaluate the extent to which TVS, capitalizing on a preserved neurocircuitry for~     sympathetic and parasympathetic system activity, can be used to modify arousal responses,~     increase positive affective emotions, overriding otherwise prepotent negative stress~     reactions. Mindfulness is a popular intervention for stress. Yet it does not work for~     everyone. The investigators suggest this is because mindfulness relies on interoception which~     is not strong (or not sufficiently practiced) in everyone. Here the investigators provide an~     extroceptive cue (TVS) which increases activity in the same networks tapped by mindfulness.~      The investigators will show that this cue, which is physiologically reactive, decreases~     stress and increases physiological indicators of emotion regulation, and further show that it~     will do this during mindfulness yielding increased effects of mindfulness, to the extent that~     some individuals will experience heightened states of awareness, often described by advanced~     practitioners with thousands of hours of meditation. 100 individuals will be assessed~     physiologically during active intervention. Mechanisms of attentional focus on tasks will be~     assessed. Success will suggest that a dynamic intervention is possible without effort,~     medication or psychotherapy.~   "
2818|NCT03529968|"~     In Siewert type I/II EAC, sensitivity/specificity of CT, PET-CT, EUS for assessment of N~     descriptor in defined groups of lymph nodes were investigated.~   "
2819|NCT03529955|"~     With limited treatment options available for dermatomyositis, the investigators hypothesize~     that apremilast, a phosphodiesterase-4 (PDE-4) inhibitor, is a safe and efficacious add-on~     treatment in patients with refractory cutaneous dermatomyositis.~      The study will investigate the efficacy, safety and toxicity of apremilast given at 30 mg~     twice daily to patients with refractory cutaneous dermatomyositis. Clinical response will be~     assessed at 1 and 3 months. Patients will also be evaluated for durability of their response~     for up to 6 months.~      Treatment will be monitored with frequent clinical visits (0, 1, 3 and 6 months) and blood~     tests (CBC, CMP, creatine kinase, aldolase). Treatment will be discontinued at disease~     progression or unacceptable adverse events. Disease progression is defined as 4 points~     increase in the cutaneous dermatomyositis disease area and severity index (CDASI) score,~     worsening of muscle disease by manual muscle testing (MMT-8) score and 5 points increase in~     dermatomyositis life quality index (DLQI).~      5 mm skin biopsies from lesional skin will be performed before treatment with apremilast and~     after 3 months of treatment for gene expression profiling and confirmatory~     immunohistochemical stains.~   "
2820|NCT03529942|"~     This is an open-label study assessing the effect of the administration of a single~     intra-articular (IA) injection of FX006 32 mg on synovial volume in patients with~     osteoarthritis (OA) of the knee.~   "
2821|NCT03529929|"~     In this project, we propose to investigate the metabolic consequences of glucocorticoid~     therapy, given orally as a 6 day Medrol Dose pack, on human skeletal muscle as measured by~     western blotting and PCR and skeletal muscle mitochondrial capacity as measured by~     High-Resolution Respirometry in healthy individuals. Medrol is an FDA approved drug with many~     clinical indications.~   "
2822|NCT03529916|"~     The objective of this study is to identify relevant signature gene networks of cardiovascular~     disease in endothelial cells derived from circulating endothelial progenitor cells of~     individuals with established cardiovascular disease (CVD).~   "
2823|NCT03529903|"~     Lifestyle behaviors such as sleep, diet, and physical activity, are implicated in a number of~     chronic conditions including hypertension, obesity, diabetes, heart failure, and obstructive~     sleep apnea. Research shows that despite awareness of this fact, patients at risk for~     lifestyle-related chronic diseases have difficulty adhering to lifestyle change~     recommendations made by their physicians, and face challenges when attempting to modify~     unhealthy behaviors. New technologies, such as wearable activity trackers and automated text~     messaging, are promising tools for monitoring and promoting healthy lifestyle behaviors among~     patients. This randomized controlled trial will evaluate the effect of a digital health~     program, which uses pre-medical post-baccalaureate or undergraduate health coaches, wearable~     activity trackers (Fitbit Charge 2), and mobile messaging, compared to wearable activity~     trackers (Fitbit Charge 2) alone in promoting lifestyle change among overweight and sedentary~     18-64 year old patients recruited from UCLA Health primary care clinics.~   "
2824|NCT03529890|"~     A prospective, single arm, multicenter, Phase II-Trial to assess safety and efficacy of~     preoperative Radiation therapy before radical CystEctomy combined with ImmunoTherapy in~     locally advanced urothelial carcinoma of the bladder~   "
2825|NCT03529877|"~     The aim of this clinical trial is to investigate the efficacy (by monitoring overall~     improvement of EB symptoms) and safety (by monitoring adverse events) of three doses of~     allo-APZ2-EB administered intravenously to patients with recessive dystrophic epidermolysis~     bullosa (RDEB).~   "
2826|NCT03529864|"~     The main objective was to determine the efficacy and safety of a therapeutic exercise program~     for students. Secondary objectives, determine the prevalence and intensity of musculoskeletal~     pain (MSP), disability, Health-Related Quality of Life (HRQOL), and satisfaction and~     perceived improvement with program.~   "
2827|NCT03529851|"~     The trial is a pilot study prior to a following phase III trial and is designed to test the~     feasibility, acceptability and technical usability of supplementary web-based follow-up in~     lung cancer via a patient-reported outcome application.~   "
2828|NCT03529838|"~     Different classes of antihypertensives may have different responses when associated with~     exercise. Thus, this study aims to compare the responses of the association of 12 weeks of~     aerobic exercise and weightlifting with different classes of medications in 45 postmenopausal~     hypertensive women.~   "
2829|NCT03529825|"~     Primary purpose of the study is to see if rifaximin can improve the balance of bacteria~     within the gut, which has been shown to improve transplant outcomes. It will also assess~     whether rifaximin can reduce the risk of infection in blood/marrow transplant (BMT).~   "
2843|NCT03529643|"~     The purpose of this study was to evaluate the effect of anesthetic method on the optic nerve~     sheath diameter in patients undergoing robot-assisted laparoscopic prostatectomy.~   "
3607|NCT03519659|"~     The purpose of this study is to assess new low radiation dose techniques for clinical PET/CT~     scans through intra-individual comparison between a clinical, standard dose scan and a~     low-dose scan, completed within one week of each other.~   "
2830|NCT03529812|"~     The Emory University Spiritual Health department will incorporate Cognitively-Based~     Compassion Training (CBCT) into their training curriculum beginning in Fall 2017, which~     provides the opportunity to compare students receiving the CBCT addendum with those receiving~     traditional chaplaincy training. This is a naturalistic study that examines the impact of~     incorporating CBCT into Emory's spiritual caregiver training program. The researchers will~     examine the effect of CBCT on empathic accuracy and resilience by comparing the first group~     of students who receive CBCT-informed training with chaplains who receive standard training~     in spiritual caregiving and receive CBCT later in the residency year. Comprehensive~     assessments will be conducted in order to examine whether outcomes for patients are improved~     for those receiving chaplain spiritual care augmented by CBCT compared to those receiving~     spiritual care from chaplains who receive CBCT later in their residency.~   "
2831|NCT03529799|"~     This study aims to determine the validity and safety of disparity driven vergence using a~     portable goggle system (I-PAS) using a pseudorandom ternary sequence of frequencies for~     testing.~   "
2832|NCT03529786|"~     Mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome, is caused by a~     deficiency of iduronate-2-sulfatase (IDS) leading to an accumulation of glycosaminoglycans~     (GAGs) in tissues of MPS II patients, resulting in characteristic storage lesions and diverse~     disease sequelae, and in patients with the more severe form of the disease, irreversible~     neurocognitive decline and higher morbidity and mortality than in patients with the~     attenuated form of the disease.~      There is currently limited information on the natural history of MPS II, especially with~     respect to neurocognitive decline in patients with the more severe form of the disease. This~     study is planned to be an observational medical records review study (data collected~     retrospectively and no investigational product treatment or procedures) in subjects with the~     severe form of MPS II. Collectively, the data may inform the design of future MPS II gene~     therapy treatment studies and may be utilized as historical comparative control data.~   "
2833|NCT03529773|"~     The study will describe the safety, tolerability, and immunogenicity of up to 6 RSV vaccine~     formulations when administered alone or concomitantly with seasonal inactivated influenza~     vaccine (SIIV).~   "
2834|NCT03529760|"~     Children with clinically diagnosed leukemia may experience occult HBV infection after~     chemotherapy immunosuppressive therapy, which may affect the normal course of leukemia~     treatment. However, this is not caused by clinically relevant diagnosis and treatment~     measures but exists in vivo.~   "
2835|NCT03529747|"~     This study aims to conduct an initial evaluation of whether online self-help can improve the~     quality of life of parents of children with food allergies.~   "
2836|NCT03529734|"~     In this research project, effects of two sports specific types of fatiguing protocols on~     trunk muscles and specific trunk stability indicators will be studied. In general, sports~     activities involving gross motor activities activate higher percentage of muscle mass. In~     addition, such activities usually demand increased ventilation and more demanding~     inter-muscular activation. Such an example is running, with medium intensity until exhaustion~     or with the goal to cover the longest distance possible in a given time. On the contrary,~     sports practice often incorporates local strengthening exercises into a workout, especially~     for the trunk muscles. These, if performed correctly, cause localized muscle fatigue and can~     affect their function. Understanding the effects of these activities is of importance for~     coaches as well as for health care providers, as other types of training usually follow such~     activities that can more easily lead to trunk or spinal overload. We expect that localized~     muscle strengthening protocol until exhaustion will have more detrimental effects on trunk~     stability indicators as fatiguing with exhaustive running.~      In these study 100 subjects will be studied, divided into two groups. First group will~     perform an exhaustive running protocol and the second group a localized trunk muscle~     strengthening protocol until exhaustion. The effect of intervention will be studied by~     observing the changes in trunk muscle reflex responses following sudden arm loading and~     changes in anticipated trunk muscle activation during a quick arm raising task. Activation~     latencies and electromyographic (EMG) amplitude, and center of foot pressure excursion will~     be used to quantify trunk stability. In addition, center of pressure movement during a~     sitting balance task will be studied as to gather information of local trunk stabilization~     functions. Finally, changes in joint position sense will be assessed in order to account for~     the possible changes in kinesthesia.~   "
2837|NCT03529721|"~     Each female sets her experience of 47 manifestations on a 6 point scale separately for the~     premenstrual, menstrual and intermenstrual phases of her latest and worst menstrual cycle.~     Daily Symptoms Report will be filled at the start and at end of the study (before and after~     performing swimming exercise) Females in group I will be instructed to engage into 12 classes~     of 60-minute Zumba® fitness over an 8-week period.~   "
2838|NCT03529708|"~     Spinal cord compression (SCC) is a devastating complication of advanced malignancy, and can~     cause significant deterioration in function and quality of life (QoL). The goal of treatment~     is to improve functional status and symptoms, but the optimal treatment regimen for these~     patients has not been thoroughly established. Many patients with SCC present with~     uncontrolled systemic disease and poor performance status, and are not eligible for standard~     surgical resection. They are generally treated with 3D conformal palliative RT (3DCRT) alone,~     however recent trials suggest that less than 70% of patients are ambulatory, that the~     re-establishment of ambulation in non-ambulatory patients is poor, and the duration of~     improvement is guarded with radiotherapy alone.~      Recently, stereotactic body radiotherapy (SBRT) used alone or after previous radiotherapy to~     treat spinal metastasis has demonstrated superior results in pain control, tumour response~     and durability. SBRT requires time for careful planning, and many patients with neurologic~     symptoms must be treated immediately to prevent progression. Therefore the role of SBRT is~     still unclear in this patient population, although it seems to be a potential alternative to~     surgical decompression in patient not suitable for surgery. The investigators propose a~     feasibility study to investigate the potential benefits of dose escalation with a sequential~     SBRT boost to urgent 3D CRT in the setting of SCC. This regimen will allow inoperable~     patients to receive urgent 3DCRT while simultaneously creating the opportunity for superior~     outcomes with SBRT. The investigators also aim to characterize the effect on motor function~     and ambulation, pain and QoL. This study could stimulate further multi-center randomized~     trials in this area, improve motor function and patient-reported QoL, and contribute to~     improving oncology care in Canada in a meaningful way.~   "
2839|NCT03529695|"~     Existing obesity prevention efforts have had limited success among underserved, low-income~     children. This study capitalizes on the strengths of a nationwide ongoing Home Visitation~     Program (HVP), which serves at-risk, low-income, ethnically/racially diverse mothers and~     their infants, to test the effectiveness of delivering obesity prevention as part of their~     weekly, in-home services. The study will evaluate whether the integration of an obesity~     prevention enhancement module into existing HVP services, reduces the risk and incidence of~     obesity and associated risk factors in mothers and infants, compared to the provision of~     standard home visitation services. The study also focuses on the role of maternal factors~     (maternal diet, physical activity, food insecurity and feeding practices) and social factors~     (social network support) as mechanisms operating on infant outcomes.~   "
2840|NCT03529682|"~     The aim of our study is to reveal the results of circuit training to be applied to the~     children with Cerebral Palsy (CP) for improving their muscular strength and trunk control and~     also to determine their effects in terms of activity limitations and participation limits.~   "
2844|NCT03529630|"~     Breastfeeding is the ideal infant nutrition recommended by governmental and medical~     professional organizations. Yet, women with inverted nipples often face difficulties in~     breastfeeding that ultimately force them to prematurely terminate breastfeeding. This~     open-label randomized clinical trial aims to investigate the effectiveness of the use of the~     inverted syringe technique on exclusive breastfeeding success in women with inverted nipples,~     as compared to standard of care.~   "
2845|NCT03529617|"~     This prospective study will compare the pharmacokinetic exposure to liposomal amphotericin B~     between critically ill patients and non-critically ill (hematology) patients in an early and~     late exposure day.~   "
2846|NCT03529604|"~     According to the World Health Organization, oral cancer (OC) is the eighth most common cancer~     in the world with a five year survival rate of 50%.~      Oral cancer tumor cells produce biochemical substances, tumor markers, differed from healthy~     individulals in expression or quantitative ratio, detectable in tissues and/or body fluids.~      Saliva, bacause of its accessibility, proximity and noninvasive approach, presents an ideal~     tool for the research of oral cancer tumor markers.~      The aim of this study will be to isolate, quantify, analyze the role and describe the~     kinetics of diadenosine tetraphophate (Ap4A), Squamous Cell Carcinoma associated Antigen~     (SCCA), Trophoblast cell surface antigen (TROP2) in patients with OC, potentially malignant~     disorders (PMOD) and age and sex matched control group with a clear medical history.~      There are number of studies published on OC tumor markers isolated mostly in serum, however~     the satisfactory specificity and sensitivity still hasn't been reached.~      Liqiud chromatography-ion trap-mass spectrometry, Multiple Reaction Monitoring method~     (LC-IT-MS, MRM) will be developed to isolate and quantify the above mentioned tumor markers.~     To our knowledge, this method hasn't yet been used to quantify the above mentioned salivary~     tumor markers. Ap4A and TROP2 have never been isolated from saliva.~      Our goal is to develop a tumor-specific test with a satisfactory statistical sensitivity and~     specificity and dynamically measure the levels of tumor markers, before and immediately after~     therapy - surgery/radiotherapy/chemotherapy or their combination, and during regular~     follow-up one and two years after surgery. As another novelty, we will dtermine the markers~     circadian rhythm.~      A OC tumor specific test, with satisfactory sensitivity and specificity, would enable earlier~     OC diagnosis, possibly before the clinical appearance, raise the survival rate of OC~     patients, enable early diagnosis of recurrence and/or new primary tumors and ensure better~     post-treatment life-quality.~   "
2847|NCT03529591|"~     The study is a prospective randomised controlled intervention comparing the intraocular~     pressure outcomes following Selective Laser Trabeculoplasty (SLT) treatment of 180 degrees~     SLT compared to 360 degrees in treatment naive patients with bilateral ocular hypertension or~     primary open angle glaucoma . The right eye of each patient will be randomised to receive~     either 180 or 360 degrees SLT, while the fellow eye will receive the opposite treatment. That~     is, if the right eye is randomised to 180 degrees SLT, then the left eye will receive 360~     degrees SLT.~      The primary objective is to assess the mean difference in intraocular pressure between two~     eyes of each participant. The mean difference in IOP will be assessed at two weeks and at~     one, three and six months after treatment with SLT.~      Secondary outcomes include assessing whether there are differences in visual acuity, anterior~     chamber inflammation, visual field progression and the rate of complications between the two~     eyes treated with either 180° or 360° of selective laser trabeculoplasty. The complications~     assessed are those published in the literature including: pain, blurred vision, anterior~     chamber inflammation, IOP spike, and hyphaema. Additionally, participants will be given the~     opportunity to report symptoms experienced through free text.~   "
2848|NCT03529578|"~     The purpose of this study is to investigate the efficacy and safety of dehydrated~     amnion/chorion membrane (dHACM) in the treatment of patients with stage II or III pressure~     ulcer and decubitus ulcers~   "
2849|NCT03529565|"~     This trial studies histamine and bone pain association in participants with breast cancer~     that has spread to the bone. Studying histamine levels in samples of blood from participants~     with breast cancer in the laboratory may help doctors learn more about reducing cancer bone~     pain and preventing further bone metastasis.~   "
2850|NCT03529552|"~     The investigators will evaluate the benefit of a new bioresorbable screw for repair of~     anterior cruciate ligament over 3 years.~   "
2851|NCT03529539|"~     A single patient protocol for intermediate grade nonfunctional metastatic pancreatic~     neuroendocrine disease that has exhausted all standard therapy having progressed on~     chemotherapy and immunotherapy.~   "
2852|NCT03529526|"~     This is an open-label, multicenter, dose-escalation phase I study to assess the safety,~     tolerability and preliminary efficacy of KN046 in participants with all advanced solid tumors~     who are not able to have current standard anti-tumor therapies. The purpose of this study is~     to determine the maximum tolerated dose (MTD) or a biological effective dose (BED), to~     characterise the safety, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and~     anti-tumor activity of KN046 as a single agent in adult participants with advanced solid~     tumors~   "
2853|NCT03529513|"~     This study will determine whether the Medibio Depression Diagnostic Aid exceeds minimally~     acceptable thresholds for sensitivity and sensitivity in cases with a current depression~     episode and non-depressed controls.~   "
2854|NCT03529500|"~     Malnutrition is a public health problem that can exert a negative impact on the general and~     oral health of children. The aim of the present study was to evaluate the effect of chronic~     malnutrition on the oral health of children aged one to five years. An observational,~     analytical, cross-sectional study was conducted at the Nutritional Recovery Center and~     involved 82 children between 12 and 71 months of age. Nutritional status was evaluated using~     anthropometric indicators and oral health status was measured using the dmft index.~     Non-stimulated saliva was collected. Flow rate and buffering capacity was then measured with~     the aid of a pH meter.~   "
2855|NCT03529487|"~     This is a Phase 1, open-label, repeat dose, ascending dose study assessing the PK, safety,~     tolerability, PD, and dose- or exposure-response of Topical Oxymetazoline for intra-anal~     application. A total of 20 healthy male and female subjects will be enrolled (4 subjects in~     the first cohort and 8 subjects in the remaining cohorts) and will be exposed to Topical~     Oxymetazoline 1 mg, 5 mg or 10 mg applied intra-anally QD for 11 consecutive days.~   "
2856|NCT03529474|"~     This study evaluates the clinical impact of a combined protocol with cognitive-behavioral~     intervention and physiotherapy adjuvant to the standard medical treatment in patients with~     haemophilia that suffer from chronic pain~   "
2857|NCT03529461|"~     The study evaluated the effect of non-invasive positive pressure ventilation (NIPPV) to~     decrease the incidence of desaturation events in patients with severe obesity undergoing~     upper endoscopy.~   "
3608|NCT03519646|"~     Evaluation of the safety in the combination usage of Cerdelga and Cerezyme in type III~     Gaucher disease patients and the efficacy on soft tissue diseases.~   "
2858|NCT03529448|"~     Glioblastoma is the primary brain tumour with the worst prognosis: median survival is only 12~     months despite the use of the most advanced treatments. In the past 10 years, survival in the~     treatment of this disease has not advanced significantly, with the postoperative standard~     being the administration of chemoradiotherapy with temozolomide, followed by 6 cycles of~     sequential chemotherapy with temozolomide.~      Δ9-tetrahydrocannabinol (THC) and cannabidiol (CBD) have shown a clear synergistic antitumour~     effect with temozolomide and radiotherapy in preclinical glioma models. THC and CBD have a~     wide variety of biological effects by binding with and activating the type 1 and type 2~     cannabinoid receptors (CB1 expressed in certain neuronal areas of the brain and CB2 expressed~     in the immune system and in glial cells). The activation of these receptors initiates a~     signalling pathway, called the endoplasmic reticulum stress response, which generates tumour~     cell autophagy by activating TRB3.~      Given these data, the Spanish Group for Neuro-oncology (GEINO) proposes developing a phase~     Ib, open-label, multicenter, intrapatient dose-escalation clinical trial to assess the safety~     profile of the THC+CBD combination at a 1:1 ratio, adding temozolomide and radiotherapy in~     patients with newly-diagnosed glioblastoma.~      The number of patients to be recruited is 30 over 6 months at 8 sites specialising in~     neuro-oncology.~   "
2859|NCT03529435|"~     The study compares two intensive outpatient behavioral programs (Massed Prolonged Exposure~     versus Intensive Outpatient Prolonged Exposure) for the treatment of posttraumatic stress~     disorder (PTSD) in post-9/11 active duty service members and veterans. The researchers hope~     to learn if these programs improve treatment outcomes. The researchers predict that Intensive~     Outpatient Prolonged Exposure (IOP-PE) will be better at treating PTSD than Massed-Prolonged~     Exposure (Massed PE).~   "
2860|NCT03529422|"~     The purpose of this study is to investigate other drugs that may be combined with radiation~     to treat cancer. The study focuses on determining whether a combination of two~     investigational immunotherapy drugs, durvalumab and tremelimumab, with radiation can both~     improve cure rate and at the same time have less serious side effects. Throughout this~     document, these investigational drugs will be referred to together as the study drugs, or~     named individually (durvalumab or tremelimumab). The study drugs in this research are~     referred to as investigational because the U.S. Food and Drug Administration (FDA) has not~     yet approved them for the treatment of head and neck cancer. Durvalumab was FDA approved in~     2017 for the treatment of certain types of bladder cancer, but has not been approved for use~     in Head and Neck cancer patients.~      Durvalumab and Tremelimumab are experimental drugs that use the body's immune system to fight~     the cancer. The combination of these study drugs is being used in other ongoing clinical~     trials for other types of cancers. The doctor feels that a patient may experience fewer side~     effects using these study drugs with radiation rather than using cisplatin. The doctor is~     also investigating whether using these drugs can increase the effectiveness of treatment.~   "
2861|NCT03529409|"~     The purpose of this study is to test the effectiveness and implementation of a brief,~     integrated behavioral intervention for HIV medication adherence and substance use in the HIV~     care setting in South Africa. The intervention is specifically designed to be implemented by~     non-specialist counselors using a task sharing model in local HIV clinics. The behavioral~     intervention will be compared to usual care, enhanced with referral to a local outpatient~     substance use treatment program (Enhanced Standard of Care - ESOC) on study endpoints (as~     described in study endpoint section below).~   "
2862|NCT03529396|"~     A clinical study to assess the safety and efficacy of alternative regimens of primaquine for~     radical cure of vivax malaria in glucose 6-phosphate dehydrogenase (G6PD) deficient. G6PD~     deficient patients with P. vivax monoinfection will be treated with either weekly or delayed~     one-week course of primaquine, and the currently recommended by national guideline, 12-week~     chloroquine regimen to compare treatment safety among groups. All groups will be actively~     monitored for hemolysis during treatment and will have six-month follow-up period to assess~     treatment efficacy.~   "
2863|NCT03529383|"~     The 3-year DISCO study aims to systematically implement physical activity in breast cancer~     patients. The primary objective is to investigate the efficacy of a connected device~     (personalized non-supervised exercise program including a wristband as activity tracker, a~     smartphone application, and a website) and the efficacy of a therapeutic education program on~     the physical activity level of patients at the end of the 6-month programs. The research~     hypothesis is that patients participating in the intervention with the connected device or in~     the therapeutic education program will achieve the international recommendations in terms of~     physical activity, compared to women receiving only physical activity recommendations.~   "
2864|NCT03529370|"~     In this study the invistigators chose to measure the optic nerve sheath diameter by~     sonography for diagnosis of elevated intracranial pressure (ICP) in comparison to brain~     computed tomograhy (CT) as the reference gold standard for detection of raised ICP since~     optic nerve songraphy is radiation-free , noninvasive, and has certain features which~     increase its convenience portability, easy application, low cost, repeatability on request,~     bedside application, short application time and applicability even in the presence of~     unstable vital signs.~   "
2865|NCT03529357|"~     This cohort study investigates how implementation of Biological Age technology in worksite~     health promotion, affects health behavior in the general Danish working population.~   "
2866|NCT03529344|"~     The elderly population have and increased risk of loss of both muscle mass and function and~     is therefore recommended a higher protein intake than the healthy adult population. These~     age-related changes in muscle function may be explained by chronic low-grade inflammation and~     insulin resistance. Despite the recommendation of a higher protein intake, little is known~     about how different protein sources may affect the metabolic health in this population.~     Analysis of amino acid composition show that fish can be a good protein source for humans.~     Many fish species are today used as feed ingredients, rather than a protein source for~     humans. A few studies conducted in humans and rats show that proteins from fish may improve~     glucose tolerance, reduce inflammation and improve lipid metabolism, indicating that proteins~     from fish may not only serve as a valuable nutrient but could also hold specific health~     promoting properties.~      The present study will investigate the effects of a protein hydrolysate from blue whiting, a~     fish species normally used to produce fish meal for aquaculture industry, on glucose~     homeostasis, inflammation and serum lipids in elderly nursing home residents.~   "
2867|NCT03529331|"~     This is a prospective randomized, clinical trial comparing recurrent use of Morphine Sulfate~     Immediate Release (MSIR), Oxycodone/Acetaminophen (Percocet), and Hydrocodone/Acetaminophen~     (Vicodin) at discharge from the emergency department for opioid-naive adult patients~     presenting with moderate-to-severe pain. At discharge, patients will be randomized to receive~     either 5 mg of Oxycodone/Acetaminophen (Percocet) tablet 4 times a day for 5 days, 5 mg of~     Hydrocodone/Acetaminophen (Vicodin) tablet 4 times a day for 5 days, or 15 mg Morphine~     Sulfate Immediate Release (MSIR) tablet 4 times a day for 5 days. At 1 month, 3 months, and 6~     months patients' prescription's history will be accessed by using the DoctorFirst Drug~     Database to determine the recurrent use that will serve as a surrogate marker of likeability~     and abuse liability of each prescribed opioid.~   "
2868|NCT03529318|"~     Crohn's disease and ulcerative colitis are types of chronic intestinal disorder called~     inflammatory bowel diseases (IBD) that can affect the small and large bowel causing symptoms~     of abdominal pain, diarrhea, blood in the stool, and weight loss. Irritable bowel syndrome~     (IBS) is a milder form of IBD, with symptoms of abdominal pain, bloating, diarrhea or~     constipation, and blood in the stool. It is not known what causes diseases such as IBD and~     IBS. This study will look at the events in the gut that leads to leaky gut and inflammation~     in patients with IBD and IBS. The study will also see if medications such as rifaximin and~     mesalamine may reduce the amount of leaky gut.~   "
2869|NCT03529305|"~     In this study, the investigators aim to evaluate functional and structural improvements in~     the brain of stroke patients after rTMS treatment using multi-modal MRI techniques.~     Specifically, the investigators sought to determine whether rTMS treatment modulate the brain~     function and structure in patients and, if so, whether different frequency of the rTMS~     treatment will affect the degree of the motor recovery in patients' brain.~      The patients will be randomized into three groups: Experimental group 1 (TMS group) received~     low frequency rTMS; Experimental group 2 (TMS group) received high frequency rTMS; The third~     group who received only physical therapy constituted the control group. All patients undergo~     MRI scan one day before and after rTMS treatment.~   "
2870|NCT03529292|"~     The purpose of this study is to evaluate the filling using the modified matrix, obtained by~     the Ameacell® device from autologous adipose tissue and intended for the filling of wrinkles~     on the face.~   "
2871|NCT03529279|"~     Due to the increase of tumor control rate and survival rate in era of IMRT, the role of the~     seventh edition of UICC/AJCC staging system in predicting prognosis is becoming weaker and~     inaccurate.~      Therefore, we put forward a new staging for the clinical staging of NPC in the era of IMRT~     without changing the current T, N, M staging definition of the 7th of the UICC/AJCC staging~     system. We call this new stage Cooperative Nasopharyngeal Carcinoma Group stage, namely CNG~     stage. In CNG stage, the clinical stages were reduced to three stages, namely, CNG I stage~     includes T1-3N0-1M0 and T1-2N2M0, CNG II stage includes T3N2M0, T4N0-2M0 and TanyN3M0, CNG~     III stage includes TanyNanyM1. For CNG I stage, the IMRT alone is sufficient. If EBV-DNA~     copies is more than 0 copy/ml, concurrent chemoradiotherapy will be given. For CNG II stage,~     patients can benefit from combined radiotherapy and chemotherapy. For CNG III stage, patients~     are recommended for systemic chemotherapy plus local radiotherapy (primary focus, neck~     drainage area and distant metastasis).~      This year, UICC/AJCC has proposed an eighth edition of NPC staging system. The eighth version~     is mainly changed in the definition and refinement of the anatomic location compared with the~     seventh edition. This is different from our new CNG staging concept.~      Therefore, CNG staging and its treatment strategy was used as the experimental group, and the~     eighth edition of UICC/AJCC staging with NCCN guiding treatment was used as the control~     group. The open and randomized controlled clinical study was conducted. The purpose of this~     study was to evaluate in the era of IMRT, CNG staging can be better than UICC/AJCC eighth~     clinical staging for treatment decision-marking and selection of chemotherapy and~     radiotherapy, and differentiating differences in prognosis in each clinical stage. The~     survival results based on CNG staging and its treatment are not inferior to the survival~     results of the NCCN guide therapy based on the eighth edition UICC/AJCC staging, to avoid~     chemotherapy for some of the patients, and to improve the outcome of metastatic patients.~   "
2872|NCT03529266|"~     The primary objective is to evaluate the efficacy and assess the role of Porcine Fibrin~     Sealant (Bioseal®) in preventing cervical anastomotic leakage after esophagectomy in the~     patients with resectable thoracic esophageal cancer and gastroesophageal junction cancer.~   "
2873|NCT03529253|"~     The purpose of this study is to verify whether additional administration of Alirocumab exerts~     a stronger stabilizing effect on the vulnerable plaque in CAD, compared with statin alone~     administration in patients receiving PCI. Therefore, the change in maxLCBI (4 mm) of the~     coronary artery 9 months after administration by addition administration of Alirocumab is~     evaluated as the main evaluation item as compared with statin administration alone for~     patients who have CAD and received PCI. Also, change of plaque properties is compared with~     baseline and evaluated. This study is a single-center, randomized, open-label study, using~     alirocumab, rosuvastatin as test drugs. Based on the findings obtained in this study, it is~     possible to clarify the mechanism of stabilization of the plaque in a patient with coronary~     artery disease, which in turn suppresses the progress of plaque in coronary artery disease,~     resulting in primary or secondary There is a possibility that it can contribute to~     prevention.~   "
2874|NCT03529240|"~     Investigators investigated that the effects of kinesilogy taping on performance, energy~     consumption and gait characteristics in patients with Duchenne Muscular Dystrophy~   "
2875|NCT03529227|"~     The study evaluate safety and effectiveness of chlorambucil and obinutuzumab in routine~     clinical practice in patients with chronic lymphatic leukemia and with certain comorbidities~     (any cardiac pathology, diabetes mellitus (DM), kidney pathology or cytopenia), whom~     obinutuzumab & chlorambucil have been applied according to indications before enrollment in~     the study.~   "
2876|NCT03529214|"~     The purpose of this study is to evaluate the feasibility of a pilot project to improve~     communication and teamwork and to increase vaginal delivery rates at hospital in the United~     States~   "
2877|NCT03529201|"~     Oxycodone consumption and postoperative pain intensity in patients undergoing nephrectomy~     procedures. Of all study participants, 50% will obtain quadratus lumborum block (QLB).~   "
2891|NCT03529019|"~     A prospective pilot study examining nutritional supplements among vascular surgery patients~     with Critical Limb Ischemia (CLI). CLI patients have a high rate of malnutrition and has the~     potential to benefit greatly from nutritional intervention. The investigators plan to~     evaluate nutrition and functional status of patients by assessing objective lab values and~     the use of the hand grip strength test. Providing perioperative nutritional supplements to~     patients has potentially improved their nutritional status, which in turn may improve the~     patient's clinical status after surgery.~   "
2892|NCT03529006|"~     The primary objective of this study is to demonstrate superiority of the Absorb scaffold~     compared to the Sequent Please Drug Coated Balloon when treating patients with~     In-Stent-Restenosis (ISR).~   "
5410|NCT03496038|"~     This is a non-inferiority study to evaluate whether L-PRF achieves similar or perhaps better~     results in bone gain, compared with the golden standard DBBM, after trans-crestal sinus~     floor elevation.~   "
2878|NCT03529188|"~     Type 1 diabetes usually appears brutally in children or young adults. While many factors of~     poor glycemic balance have been identified in the literature (age, socio-cultural and~     socio-economic level, family structure, adherence etc.), it turns out that hypoglycemia is~     the most common acute complications. It would be an important physiological and psychological~     barrier for the patient and his parents to manage this diabetes, the latter seeking to keep~     the blood glucose levels above the objectives in order to avoid the occurrence of a~     hypoglycemia, especially nocturnal.~      If there is a questionnaire currently validated as a tool to measure the fear of hypoglycemia~     (HFS, Hypoglycemia Fear Survey is available in three versions: L'HFS-Child (HFS-C) for~     children over 6 years old, HFS-Parents of Young children ( HFS-PYC) for parents of young~     children (under 8 years of age) and HFS-Parents (HFS-P)) for parents of children over 8 years~     of age, on the other hand, there are no French and no French studies have evaluated the~     prevalence and impact of the fear of hypoglycemia in French patients with type 1 diabetes.~      It is therefore essential to use a reliable and valid tool to identify patients affected by~     the fear of hypoglycemia, which can be an obstacle to improve glycemic control and to an~     optimum quality of life. Having a tool in French and validated on the scientific level would~     allow to propose adapted therapeutic treatments (psychological follow-up, individual or~     collective sessions of therapeutic education, material assistance (sensor of blood glucose,~     pump with insulin stop...) In order to both improve metabolic balance while increasing the~     quality of life of patients by lowering secondary anxiety to hypoglycemia~   "
2879|NCT03529175|"~     Metastatic pancreatic cancer is difficult to treat. Until recently, most patients would be~     offered treatment with a chemotherapy drug called gemcitabine. However, a large international~     trial showed that combining gemcitabine with a drug called nab-paclitaxel (or abraxane) was~     more effective compared with gemcitabine alone. The purpose of this study is to compare two~     different ways of combining gemcitabine with abraxane. Conventionally, both drugs are given~     on the same day via a drip into a vein in the arm but research suggests that giving abraxane~     24 hours in advance of gemcitabine could possibly be more beneficial.~      In this study, blood and tumour samples will be collected and analysed to try to confirm what~     has been seen in the laboratory studies. In addition, the investigators wish to find out~     whether certain tumour characteristics (called biomarkers) can be used to predict for~     response to chemotherapy.~   "
2880|NCT03529162|"~     This is a prospective randomized controlled trial comparing two common techniques of long~     head of biceps tendon tenodesis in shoulder surgery. Numerous techniques of biceps tenodesis~     currently exist and are commonly performed. We will be comparing the tenodesis procedure~     using a suture anchor device versus a technique where the tendon is simply sutured to the~     pectoralis major tendon.~   "
2881|NCT03529149|"~     Investigators hypothesized that the precise regulation of blood pressure based on the changes~     of cerebral blood flow parameters under TCD monitoring can better improve the state of~     cerebral blood flow, reduce the risk of early neurological deterioration and improve the~     prognosis of the patients.~   "
2882|NCT03529136|"~     Decompensated liver cirrhosis is one of the life-threatening complication of chronic liver~     disease. Liver transplantation currently is the only effective method that can improve the~     survival of these patients. However, the severe shortage of donor livers, high cost, and~     potential serious complications have restricted the availability of liver~     transplantation.Umbilical cord mesenchymal stem cells (UC-MSC) has been generally shown to be~     safe and effective for liver diseases in some pre-clinical and clinical studies. This study~     aim to evaluate the safety and efficiency of human umbilical cord mesenchymal stem cell~     transfusion in patients with decompensated liver cirrhosis, and explore the best protocol of~     MSC transfusion.~   "
2883|NCT03529123|"~     Primary Objective:~      To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination~     (FRC) to insulin glargine by demonstrating change in glycosylated hemoglobin (HbA1c).~      Secondary Objectives:~        -  To assess the effects of the FRC in comparison with insulin glargine on:~        -  Percentage of patients reaching HbA1c targets (<7% );~        -  Glycemic control in relation to a meal as evaluated by 2-hour Post-prandial Plasma~          Glucose; (PPG);~        -  Body weight~        -  Fasting Plasma Glucose (FPG);~        -  Percentage of patients reaching HbA1c targets of <7% with no body weight gain and no~          hypoglycemia (as defined in the evaluation criteria);~        -  7-point Self-Monitoring Plasma Glucose (SMPG) profile;~        -  Insulin glargine dose.~        -  To assess the safety and tolerability in each treatment group.~   "
2884|NCT03529110|"~     This study is designed to compare the anti-tumor activity as well as the safety and efficacy~     of DS-8201a versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer~     subjects previously treated with trastuzumab and taxane.~   "
2885|NCT03529097|"~     A randomised controlled trial to evaluate the role of IV fluids in renal colic.~   "
2886|NCT03529084|"~     This is a phase III, open label, randomized controlled multi-center global study designed to~     evaluate the safety and efficacy of single agent nazartinib (EGF816) compared with~     investigator's choice (erlotinib or gefitinib) in patients with locally advanced or~     metastatic NSCLC who are treatment naïve and whose tumors harbor EGFR activating mutations~     (L858R or ex19del).~   "
2887|NCT03529071|"~     The goal of this VA Innovation Seed project is to test the best approach for the delivery,~     feasibility, and usability of a patient-centered CKD-QPS to facilitate better Veteran~     understanding and engagement in their CKD-care in nephrology clinics at two geographically~     distinct VA hospitals (Chicago and Dallas) through on-going user feedback in real time.~   "
2888|NCT03529058|"~     Retrospective study in the 3 intensive care units of the Brest Teaching Hospital (France)~     during a 18-months period (June 2014 -December 2015) to study the independent association~     between hypophosphatemia and 90-day mortality.~   "
2889|NCT03529045|"~     Multicenter global post-market registry of subjects diagnosed with drug resistant epilepsy~     and treated with the VNS Therapy System.~   "
2890|NCT03529032|"~     The aim of this study was to evaluate the effect of intraoperative methadone on postoperative~     analgesic requirements, pain scores and patient satisfaction in comparison to standard~     intraoperative pain control with fentanyl in laparoscopic surgery.~   "
3472|NCT03521414|"~     The study evaluates the general anesthesia management with BIS monitorization in terms of~     hemodynamic stability, drug concentrations and drug consumption in patients who underwent~     surgery due to intracranial pathology and who were divided in three different GCS groups.~   "
2893|NCT03528993|"~     Stroke,one of the leading cause of death, is caused by ischemia or hemorrhage. It results in~     neurological deficits such as hemiplegia. Hemiplegia show disability characterized loss of~     motor, sensory and cognitive function. Reduced postural control and balance stability results~     gait disturbances such as asymmetric weight bearing, risk of falling and imbalances. It also~     shows increased energy expenditure, decreased independence on quality of life and limited~     mobility. Physical therapy can be effective method for solving these problems. Hippotherapy,~     also known as horseback riding therapy, is a form of physical therapy strategy that uses~     equine movement. The concept of hippotherapy is to use a horse as a therapeutic tool, and it~     is based on similarities in gait between the human and horse. The horse's gait provides~     patients having motor disabilities with rhythmic and repetitive movements similar to human~     walking, thereby giving them training opportunities to improve posture, balance, and~     strength. Even though it has many effect on solving these problems, hippotherapy centers are~     not enough. Due to climate and environmental situations, hippotherapy devices were improved~     and had similar effects on patients with stroke. In literature, these device mostly used on~     cerebral palsy, but investigator wants to use hippotherapy device on patient with Hemiplegia.~     For these reasons, the effects of exercises by mechanical hippotherapy device on postural~     control and balance will be investigated.~   "
2894|NCT03528980|"~     Study of the impact of weight loss induced by surgery (interventional group) or optimal~     nutritional management (control group) on sexual function in men with severe obesity~   "
2895|NCT03528967|"~     Assessment of the effectiveness of Enoxaparin, at a preventive dose, combined with Aspirin~     treatment versus Aspirin only treatment in reducing placental insufficiency in pregnant~     women.~   "
2896|NCT03528954|"~     This study aimed to know the effectivity of 0.5 mg/kg propofol in the end of anesthesia to~     reduce the incidence of postanesthetic emergence agitation in pediatric patients under~     general inhalation anesthesia~   "
2897|NCT03528941|"~     This observational retrospective study will enroll at least 158 patients affected by Chronic~     Lymphoid Leukemia (CLL) with previous HBV exposure (HBsAg negative, anti-HBc positive with or~     without anti-HBs) treated, with Ibrutinib single agent according to the IWCLL criteria 2008.~     Patients will be divided into two cohorts, one encompassing patients who received lamivudine~     and the second one including patients who received no prophylaxis. Each patient will be~     observed for one year from the first administration of Ibrutinib.~   "
2898|NCT03528928|"~     Subjects will place a surface electrode on their perineal area after a bladder-filling~     protocol. Transabdominal ultrasound will image the base of the bladder at rest, voluntary~     pelvic floor contraction, with the surface electrical stimulation and with a combined pelvic~     floor contraction and electrical stimulation active.~   "
2899|NCT03528915|"~     The French guidelines for the use of Rifamycine eye drops in delivery room to prevent~     neonatal conjunctivitis have been actualized. Only newborns exposed to risk factors of~     conjunctivitis should be treated, compared to previous guidelines, treating all newborns.~     currently, there are no data describing risk factors for neonatal conjunctivitis. This study~     evaluated the incidence of conjunctivitis with or without Rifamycine eye drops treatment in~     the delivery room. Then risk factors for neonatal conjunctivitis where analyzed.~   "
2900|NCT03528902|"~     The main purpose of this clinical trial is to examine the feasibility and effects of~     tamoxifen in subjects with pulmonary arterial hypertension (PAH). The study will evaluate how~     well the drug is tolerated, and its impact on functional condition and selected biomarkers.~     Changes in tricuspid annular plane systolic excursion (TAPSE) and other parameters determined~     by transthoracic echocardiography will be evaluated as well as changes in additional metrics~     such as six minute walk test distance, quality of life assessments, and hormone levels.~   "
2901|NCT03528889|"~     The study is designed to evaluate the use of electromagnetic tracking in multi plane femoral~     osteotomies, namely extension derotation osteotomies. The goal is to raise the precision of~     the surgical procedure in order to improve the outcome in short- and long term. All patients~     are examined with an instrumented 3D gait analysis pre- and one year postoperatively. The~     electromagnetic tracking system is evaluated against a base line CT or MRI scan serving as~     reference standard pre- and postoperatively.~   "
2902|NCT03528876|"~     Background: Gastro-esophageal (GE) cancers are a highly aggressive disease and are one of the~     major causes of cancer-related death worldwide. In general, combination chemotherapy has been~     associated with better outcomes compared with single agent chemotherapy. Fluoropyrimidine~     doublets FOLFOX (infusional 5FU and oxaliplatin) or FOLFIRI (infusional 5FU and irinotecan)~     are some of the standard first-line regimens and are less toxic than the anthracycline~     containing three drug regimen. Although platinum compounds are very effective in GE cancers,~     patients who are treated with platinum-based therapy often develop severe neuropathy and may~     not be able to tolerate a salvage second-line paclitaxel-based therapy.~      Objectives: To evaluate progression free survival, time to progression, overall survival,~     toxicity and quality of life in previously untreated patients with metastatic GE cancers who~     will be treated with a novel biweekly regimen comprised of two cycles of FOLFOX alternating~     with two cycles of FOLFIRI. To determine the correlation between various clinical and~     pathological biomarkers including an early FDG-PET scan response and patient outcomes.~      Design: Phase 2 clinical trial Methods: Thirty-six adult patients with histologically proven~     HER2 negative metastatic adenocarcinomas or poorly differentiated GE cancers will be~     recruited at the two major cancer centers in Saskatchewan over a period of two years.~     Patients will receive chemotherapy every two weeks and will undergo periodic imaging studies~     every 8 weeks. A Cox proportional analysis will be performed to assess various clinical and~     pathologic factors including an early FDG-PET/CT response and their correlation with patient~     outcomes.~      Significance: The LOGIC study aims to develop an effective but potentially less toxic regimen~     in the management of metastatic GE cancers, offering the possibility of longer disease~     control as a result of 100% exposure to two active doublets in a first-line treatment setting~     with lower neurotoxicities and an improved rate of salvage second-line therapy. This study~     will inform the care of patients with metastatic GE cancers and will be used to design a~     larger phase 3 trial to establish a more effective but less toxic chemotherapy regimen for~     patients with metastatic GE cancer and to establish role of FDG-PET/CT scan and other~     biomarkers in predicting outcomes.~   "
2903|NCT03528863|"~     This trial studies how well web-based mindfulness meditation works in reducing distress in~     both participants with gastrointestinal cancer that has spread to other parts of the body,~     and their caregivers. Web-based mindfulness meditation, which uses audio exercises and~     interactive webinars taught by trained meditation instructors, may help participants with GI~     cancer and their caregivers reduce distress and improve their quality of life.~   "
2904|NCT03528850|"~     The study evaluates the feasibility of providing tele-transition of care, using risk~     stratification, novel data tools, remote patient monitoring and virtual visits. A new~     communication tool for relaying tele-communication among providers caring for the virtual~     patient is introduced. The primary endpoint is 30-day readmissions.~   "
6076|NCT03487315|"~     -  To study Major allergen in Wheat anaphylaxis in Thai population~        -  To study and compare demographic data between group of wheat anaphylaxis~   "
2906|NCT03528824|"~     This randomised controlled trial aims to investigate the efficacy of fenugreek wraps in the~     treatment of primary symptomatic osteoarthritis of the knee. 81 patients will be randomised~     into one of 3 groups and apply fenugreek wraps or diclofenac gel daily for 4 weeks or receive~     only usual care. Efficacy will be measured using questionnaire on pain, disability,function,~     quality of life and pressure pain sensitivity.~   "
2907|NCT03528811|"~     The main aim of the present study was to evaluate the microcirculation of peripheral vascular~     disease in diabetes.~   "
2908|NCT03528798|"~     The primary objective of this study is to analyse medication data from the BioCog Study with~     the ApoMining-Database and to determine the positive and negative predictive value from the~     ApoMining-Database for prediction of postoperative delirium (POD).~   "
2909|NCT03528785|"~     Rational:Pancreatic cancer is a systemic disease at the time of diagnosis, even among~     patients with apparent localized disease. Surgical resection is the only potentially curative~     therapy for pancreatic cancer, but in patients who undergo surgery and postoperative therapy,~     metastatic relapse remains common and no more than 20% of patients achieve 5-year survival.~      Because of this aggressive biologic behavior, an increasing interest is growing about~     preoperative treatments in resectable pancreatic cancer.~      The combination chemotherapeutic regimen with irinotecan + 5-fluorouracil (5-FU)/leucovorin~     (LV) + oxaliplatin (FOLFIRINOX) is an effective choice for first line treatment in patients~     affected by advanced pancreatic cancer, and in this setting it achieved a Disease Control~     Rate of 70.2 % (10). In this regard, FOLFIRINOX is currently explored as preoperative regimen~     in a number of clinical trials in resectable pancreatic cancer.~      A critical challenge in this field remains the introduction in these combination treatments~     of the most novel and effective agents such as nalIRI, in order to obtain a more profound~     tumor shrinkage, to increase the rate of R0 resections, to allow an early treatment of occult~     micrometastatic disease, and eventually, to improve survival in patients with resectable~     pancreatic cancer.~      This study proposal is designed to address this challenge. Preliminary results, collected~     during the Part 1 Dose Escalation of a current clinical trial performed in mPDAC, show that~     dose of nal-IRI: 60 mg/m2, Oxaliplatin: 60 mg/m2, 5-FU/LV: 2400/400 mg/m2 is safe.~   "
2910|NCT03528772|"~     This randomized trial aims to compare two topical treatments in the treatment of chronic anal~     fissure: minoxidil gel and glycreyl trintrate cream. The endpoint of the study is the~     duration of healing of anal fissure whereas secondary endpoints include adverse effects of~     each treatment and recurrence of anal fissure~   "
2911|NCT03528759|"~     Streptococcus pseudopneumoniae as suggested by DNA-DNA homology studies is recorded as a~     species of the Streptococcus mitis/oralis members of viridans group Streptococci; they have~     some similar features to the Streptococcus mitis/oralis members of viridans Streptococcus~     pneumoniae~   "
2912|NCT03528746|"~     The purpose of this study is to compare the acute effects of two different types of~     resistance exercise (isometric versus isotonic) on exercise induced hypoalgesia during an~     aggravating activity, in participants with patellar tendinopathy.~   "
2913|NCT03528733|"~     A single-centre, industry sponsored, pilot study to assess the feasibility of Single Exposure~     Dual Energy Subtraction with a Multi-Energy digital radiography detector as an imaging~     platform for lung lesion detection.~   "
2914|NCT03528720|"~     Diabetic retinopathy(DR) is one of the most common and serious microvascular complications of~     diabetes,which is the primary cause of vision loss of diabetic patients. The risk of~     blindness is 25 times that of healthy people.Fundus fluorescein angiography (FFA) is the gold~     standard for diagnosing the stage of diabetic retinopathy.However,FFA is an invasive~     examination which requires the patient to be in good physical condition and is not suitable~     for large-scale screening.Therefore, it is important to build up an evaluation system for~     early diagnosis of DR,which is more convenient, safer, and non-invasive.Firstly, this study~     will retrospectively analyze the FFA images of DR to find the earliest and most frequently~     occurring fundus quadrant.Secondly,based on the retrospective analysis results, a prospective~     comparative study will be conducted,which combines the fundus photography with optical~     coherence tomography angiography(angio-OCT) and physical indicators to find out whether it~     has consistency, sensitivity and specificity with FFA in diagnosing the stage of DR in order~     to build up a more effective,safer and faster evaluation system and clinical application for~     DR.~   "
2915|NCT03528707|"~     One of the potential ideal strategy for NAFLD treatment may be manipulation with gut~     microbiota. Probiotics are defined as live microorganisms that, when administered in adequate~     amounts, confer a health benefit on the host. Omega-3 fatty acids belong to the family of~     polyunsaturated fatty acids. They are known to exert a strong positive influence on~     metabolism and inflammation. The data from animal studies suggested that both probiotics and~     omega-3 can affect body weight, influence on glucose and fat metabolism, improve insulin~     sensitivity and reduce chronic systemic inflammation. In respect to experimental data, the~     current study aim was to provide double-blind single center RCT, for study the efficacy of~     co-administration of probiotic with omega-3 vs. placebo in type 2 diabetes patient with NAFLD~     detected on ultrasonography~   "
2916|NCT03528694|"~     This is a randomized, open-label, multi-center, global, phase III study to determine the~     efficacy and safety of Durvalumab + BCG combination therapy in the treatment of patients with~     non-muscle-invasive bladder cancer.~   "
2917|NCT03528681|"~     To evaluate the efficacy of two different doses (5 and 10 g) of ZS orally administered once~     daily (qd) vs placebo in maintaining normokalemia in initially hyperkalemic patients having~     achieved normokalemia following two days of initial ZS therapy (10g TID).~   "
2918|NCT03528668|"~     This study will evaluate the acceptability, use, and general effect that exposure to virtual~     reality has on hospitalized patients reporting at least one discomfort including recent or~     current moderate-severe pain.~   "
2930|NCT03528512|"~     Often, repair of the cuts (laceration repair) proves to be traumatic for the children and the~     parents. Nasal spray (Intranasal/IN) approaches for procedural pain reduction, such as during~     dental work, have been demonstrated to make drug administration painless and well tolerated.~     We are comparing IN ketamine to IN midazolam and fentanyl for pain and reducing anxiety~     during repair of cuts in children.~   "
3639|NCT03519230|"~     To evaluate the efficacy, safety tolerability of maintenance therapy with BGB-290 versus~     placebo in Chinese patients with recurrent ovarian cancer who achieved a complete response~     (CR) or partial response (PR) after platinum-based chemotherapy~   "
2919|NCT03528655|"~     During early postpartum period, mother-infant proximity is important for breastfeeding~     success. Rooming-in and separate care are both traditional practices. Rooming-in involves~     keeping the mother and the baby together in the same room after birth during hospitalization,~     whereas separate care keeps the baby in the hospital baby room. Shared decision making with~     decision aid (DA) is a way to provide information to pregnant women and to involve them in~     making decisions about their strategy on baby care. We have developed a DA to be administered~     during consultation for pregnant women, and conducted a randomized controlled trial (RCT) to~     evaluate the benefit of DA on decision making. The measurements include a battery of~     interview-based questionnaires and evaluations of decision regret. We expect the DA would~     benefit the intervention group in the aspects of knowledge and communication in choosing~     mother-baby care options.~   "
2920|NCT03528642|"~     This phase 1b trial studies the side effects and best dose of glutaminase inhibitor CB-839~     hydrochloride (CB-839) in combination with radiation therapy and temozolomide in treating~     participants with IDH-mutated diffuse or anaplastic astrocytoma. CB-839 may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses~     high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as~     temozolomide, work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or stopping them from spreading. Giving CB-839 with~     radiation therapy and temozolomide may work better in treating participants with IDH-mutated~     diffuse astrocytoma or anaplastic astrocytoma.~   "
2921|NCT03528629|"~     The purpose of this study is to assess the safety, tolerability and antitumor activity of~     IMAB362 in Japanese subjects with locally advanced or metastatic Gastric or GEJ~     adenocarcinoma whose tumors have Claudin (CLDN) 18.2 Expression. This study will also assess~     pharmacokinetics and immunogenicity of IMAB362.~   "
2922|NCT03528616|"~     • Supraventricular tachycardia (SVT) is defined as an abnormally rapid heart rhythm~     originating above the ventricles. It usually has narrow complex tachycardia but this is not~     always the case. Conventionally, atrial flutter and fibrillation are excluded from this~     group.ventricular tachycardia is the most common rhythm disturbance seen in children.(2) Most~     general practitioners will deal with a case at some point. While in most cases ventricular~     tachycardia can be considered a benign rhythm disorder, special consideration needs to be~     given to infants, athletes and patients with Wolff-Parkinson-White syndrome.~   "
2923|NCT03528603|"~     The investigators have previously observed a reduced level of platelet aggregation 2 hours~     after healthy male individuals were asked to drink extra virgin olive oil (EVOO) that~     provided a higher level of one specific phenolic known as oleocanthal. This study will help~     the investigators further determine the effects of oleocanthal-rich EVOO intake on platelet~     function at 2, 4 and 6 hours after intake with food compared to platelet function in the~     morning after an overnight fast.~   "
2924|NCT03528590|"~     Currently, the main method for selecting an i-gel® size is based on the body weight~     recommendation (30-60 kg for size 3 and 50-90 kg for size 4) according to the manufacturer's~     recommendation. However, there is an overlapping in size selection in people weighing between~     50 and 60 kilograms. Laryngeal mask airways are widely used for breast surgery, and this~     patient cohort is often weighed between 50-60 kilograms in National Taiwan University~     Hospital. Therefore, in this randomized clinical trial, the investigators will compare the~     ventilation efficacy of size 3 and size 4 i-gel® in anesthetized, paralyzed female patients~     weighing 50 to 60 kilograms who undergo breast surgery. Also, the investigators will record~     any side effects of size 3 and size 4 i-gel® in this cohort.~   "
2925|NCT03528577|"~     To Evaluate the Pharmacodynamic Equivalence of Albuterol Sulfate Inhalation Aerosol, eq 90~     mcg base (Sun Pharmaceuticals Industries Limited) to PROAIR® HFA (albuterol sulfate)~     Inhalation Aerosol, eq 90 mcg base (Teva Respiratory, LLC) in Subjects With Stable, Mild~     Asthma~   "
2926|NCT03528564|"~     The HOPE-Hb trial is a phase II study to determine the feasibility and impact of a~     combination treatment (intravenous iron plus erythropoietin) versus intravenous iron~     treatment alone on preoperative hemoglobin concentration before hip or knee arthroplasty.~   "
2927|NCT03528551|"~     This study will look at how a known study medicine N8-GP works in previously N8-GP treated~     people with haemophilia A. The aim is to look at how N8-GP works during regular use.~     Participants will get N8-GP. N8-GP has been tested in more than 200 people with haemophilia A~     for several years. Participants will get an injection of N8-GP into a blood vessel, one, two~     or three times weekly. Participants will get more doses if they bleed or if they will need a~     surgery. The study will last for about 2 years. Participants will have at least 9 visits with~     the study doctor. If participants agree to be in this study, they will get their first~     injection (in this study) at the first visit. Participants will also get an injection at~     visit 3, 5 and 7. Participants will be trained to give all other injections themselves.~     Participants must not use any clotting factors other than N8-GP or any anticoagulants (blood~     thinners) during the study.~   "
2928|NCT03528538|"~     1. The problem: There is limited research on the use of herbal supplements in general, and~          fenugreek specifically, to improve male health, particularly to increase testosterone~          levels. As well, no located studies have examined the effects of fenugreek~          supplementation on healthy men's health-related quality of life, anxiety levels, and~          body composition.~        2. Relevant research examined the effects of fenugreek supplementation with healthy men~          aged between 43 and 70 years of age. The researchers found that both total serum~          testosterone and free testosterone increased compared to placebo after 12 weeks of~          active treatment. The researchers concluded that fenugreek supplementation was a safe~          and effective treatment for reducing symptoms of possible androgen deficiency, improves~          sexual function and increases serum testosterone in healthy middle-aged to older men.~          Another study found that fenugreek supplementation improved aging male symptoms and~          testosterone levels remained in a normal range in healthy men aged 25 to 45 years.~        3. The importance of this study: The importance of this study is to help determine if~          fenugreek supplementation affects testosterone levels, body composition, health-related~          quality of life, anxiety, and aging symptoms in healthy men aged 21 - 45 years.~   "
2929|NCT03528525|"~     This study is a multicenter, prospective cohort study of patients diagnosed with respiratory~     monogenic diseases, the clinical information of recruited patients, including clinical~     manifestations, lung function, chest imaging, quality of life and other indicators, will be~     followed for 5 years.~   "
2932|NCT03528486|"~     Different cognitive intervention approaches have been developed to attenuate decline (e.g.,~     cognitive engagement, training, or stimulation), but it is not clear which approaches are~     efficacious. It is also not clear when, along the continuum of normal cognitive aging to mild~     cognitive impairment (MCI-a transitional stage before dementia onset), it is most efficacious~     to intervene. This randomized clinical trial will determine the efficacy of a novel cognitive~     engagement intervention approach (music training) as compared to cognitive stimulation (which~     will serve as a stringent, active control). Grounded in theory, the central hypothesis is~     that interventions enhancing central auditory processing (CAP), a strong, longitudinal~     predictor of MCI and dementia, will improve cognition. Music training is increasingly~     recognized as a feasible means to attenuate age-related cognitive decline. Prior research and~     preliminary data suggest that intense piano training enhances CAP and is likely more~     effective than cognitive stimulation. Correlational studies indicate superior CAP, executive~     function, and other cognitive abilities for adults with formal music training compared to~     non-musicians. The specific aims of the study are to examine the efficacy of music training~     relative to cognitive stimulation (active controls) to improve CAP, cognition, and everyday~     function among older adults with and without MCI. The efficacy of music training will be~     established and moderating effects of MCI status will be examined. The proposed study further~     aims to elucidate the underlying mechanisms of effective cognitive intervention approaches by~     exploring mediators of training gains. The proposed study is the first phase II randomized~     trial of music training to enhance older adults' cognition. Mediation analyses will elucidate~     the underlying mechanisms of intervention effects.~   "
2933|NCT03528473|"~     The aim of this study is to investigate the effect of a 6-months program of Adapted Physical~     Activity (APA) on body composition, insulin resistance and adipokines, oxidative stress and~     microcirculatory haemodynamics in post-menopausal, physically inactive breast cancer patients~     in oncological follow-up with or without hormone therapy that had completed adjuvant~     treatment (radiotherapy and/or chemotherapy).~      Furthermore, the study will determine the impact of APA on functional capabilities, on~     self-reported physical activity, quality of life and psychic health.~   "
2934|NCT03528460|"~     The purpose and main objective of this study is the research of pre-operative and operative~     predictive factors of short-term (1-year) and long-term (15-years) improvement of quality of~     life, motor and non-motor symptoms in Parkinson's disease patients who have undergone to~     bilateral Subthalamic Nucleus Deep Brain Stimulation.~      The hypothesis of the study is that the definition of pre-operative and operative predictive~     factors could be able to improve the pre-operative prognostic accuracy of outcome and~     complications after surgery, allowing also a better selection of the most suitable candidates~     for bilateral Subthalamic Nucleus Deep Brain Stimulation.~      For example, we can suppose that an older age at surgery, elevated axial score, a less~     preoperative dopa-responsiveness, the presence of mild executive dysfunction at surgery or an~     unfavourable social status, could negatively influence the short and long term surgery~     outcome~   "
2935|NCT03528447|"~     Pulmonary rehabilitation program with aerobic and strengthening for 3 months will be applied~     to the candidates for lung transplantation. The program will be designed to be 2 days~     supervised weekly and 3 day home program. Cognitive functions and exercise capacities of the~     patients before and after the program will be evaluated.~   "
2936|NCT03528434|"~     A randomized double-blinded placebo-controlled trial of zinc to reduce the incidence of~     severe or invasive infections in Ugandan children with sickle cell anemia (SCA).~   "
2937|NCT03528421|"~     n this study, approximately 30 patients with relapsed or refractory non-Hodgkin's lymphoma~     (NHL) were recruited for a single reinfusion of IM19-CD28 and IM19-41BB CAR-T cells. Assess~     the safety, tolerability of treatment, and initially observe the efficacy.~   "
2938|NCT03528408|"~     This is an open-label, multi-site, single-arm Phase 2 study of adjuvant nivolumab combined~     with ipilimumab for the treatment of adult subjects with completely treated high-risk ocular~     melanoma, as defined in eligibility criteria, without evidence of metastatic disease. All~     patients enrolled to the study will be treated with nivolumab 240 mg IV every 2 weeks plus~     ipilimumab 1mg/kg IV every 6 weeks. 1 cycle = 6 weeks. Treatment will continue until disease~     progression, unacceptable toxicity, patient request to discontinue or completion of~     treatment. Subjects may receive up to 25 doses of nivolumab and 8 doses of ipilimumab~   "
2939|NCT03528395|"~     Stroke creats dependancy of patients due to various associated impairments. The use of~     low-cost technologies for neurological rehabilitation may be beneficial for the treatment of~     these patients.~   "
2940|NCT03528382|"~     Background: Acute myocardial infarction (AMI) is the second cause of death worldwide. After~     AMI, the heart failure (HF) is a main cause of patient rehospitalization and death. Despite~     the total ischemic time of AMI is decreasing in general at present, the incidence of HF after~     AMI remains high. The incidence of HF in Switzerland and the United States are 25% and~     14-16%, respectively, and the epidemiological statistic of AMI in the past 10 years was~     lacking in China, but the rate has been exceeded 22% by conservative estimation. Early~     cardiac rehabilitation quality improvement system has been shown to reduce incidence of~     post-infarction HF and improve cardiovascular function. However, early cardiac rehabilitation~     has low proportion and poor quality, which lacks of standard.~      Objective: The purposes of this quality improvement study are to evaluate a pointed,~     two-phase intervention system to improve the proportion and quality of cardiac~     rehabilitation; to standardize the early cardiac rehabilitation procedure to improve the~     prognosis among patients with post-infarction HF.~      Methods: Including the period I of cardiac rehabilitation, pre-discharge (baseline)~     assessment and the period II of cardiac rehabilitation.~      Statistical analysis: Data analyses are performed using the software package SAS version 9.2~     and all tests are 2-sided with P＜0.05 denoting statistical significance. Quantitative data~     changes between groups which are compared with using the paired Student`s t test and Wilcoxon~     rank sum test according to the data distribution, and categorical data is analyzed by~     chi-square test and ranked data is analyzed by Wilcoxon rank sum test. The investigator~     compare the incidence of heart failure in early rehabilitation patients between two phases~     according to the chi-square test of the rate of two groups, to explore the role of early~     cardiac rehabilitation after AMI in reducing the incidence of HF after AMI.~   "
2941|NCT03528369|"~     This is a multi-center, randomized, double-blind clinical trial to examine the comparative~     effects on OAKP of CGS-200-1 (1% Capsaicin content) (N=40), CGS-200-5 (5% Capsaicin content)~     (N=40), and CGS-200 Vehicle (no Capsaicin) (N=40) in subjects with OA of the knees according~     to the 1986 American College of Rheumatology (ACR) criteria. Assigned doses will be applied~     at the clinic for 60 minutes on each of four consecutive days.~      Subjects will be randomized to one of the three Arms in this study: CGS-200-1 or CGS-200-5 or~     CGS-200 Vehicle (CGS-200-0). All subjects will receive 4 consecutive days of treatment and~     will then be followed up until the Day 94 visit.~      Even though both knee(s) will receive application of study test materials, with regard to~     reduction in WOMAC pain and VAS pain score associated with study treatments, only one knee~     will be indicated as the Study Knee. This will be the knee with the highest WOMAC pain~     score at screening. If both knees have equal WOMAC pain scores at baseline, then the right~     knee will be considered the Study Knee with regard to WOMAC pain and VAS pain score~     reduction.~      Data will be collected from Day 1 through Day 5 and then again on Days 19, 35, 64 and 94 for~     efficacy, tolerability, and safety measures. The Investigators, all site staff and Clinical~     Research Organization (CRO) personnel (except the Medical Monitor providing safety oversight)~     directly involved in the study will remain blinded to the treatment assignment throughout the~     trial.~   "
2942|NCT03528356|"~     The aim of this study will be to evaluate if subjects submitted to a white diet counseling~     during home dental bleaching will present better results than subjects that maintained their~     usual diets. Forty patients will be divided into two groups and randomly allocated to each~     group: usual diet (control) or white diet, avoiding dye-containing food and beverages.~     patients will be assessed through a food frequency questionnaire and color measurement using~     a spectrophotometer at baseline and six months after bleaching.~   "
2943|NCT03528343|"~     There is concern that pain prescription after outpatient pediatric surgical procedures is~     excessive and is in excess of patient need. Current practice following pediatric appendectomy~     is to prescribe all children with 5-15 doses of narcotic pain medication upon discharge~     regardless of their age, severity of appendicitis, or pain control in the hospital. This~     study examines the amount of narcotic pain control required by pediatric patients after~     undergoing appendectomy using a randomized controlled trial study design.~      Children admitted after undergoing surgical management for a diagnosis of acute appendicitis~     will be randomized at discharge to a narcotic arm or a tylenol/motrin arm. The narcotic arm~     will receive the standard of care narcotic prescription. The tylenol/motrin arm will receive~     education to use tylenol and motrin for pain control as well as a paper prescription provided~     for the sole purpose of rescue.~      Pain control will be assessed with a post-operative pain scale, patient satisfaction survey,~     and parent satisfaction survey on the days following surgery and at post-operative follow-up.~      The hypothesis is that the pain scores and patient satisfaction surveys will show no~     difference in post-operative pain control between the two arms.~   "
2944|NCT03528330|"~     This study designed as a randomized controlled split-mouth trial will be conducted at the~     Dental Clinic of the University of Valencia. The aim will be to assess differences in~     clinical, radiological and microbiological outcomes between implants with 2 different~     connections: internal hexagon and conical connection. Following the premises, to minimize the~     bias related to prosthetic phase and maximize the effect of connections on MBL changes, a~     1abutment-1time protocol will be used.~      The study hypothesis is that there will be no statistically significant differences between~     both implant connections.~   "
2945|NCT03528317|"~     The aims of this study are as follows: AIM 1: To examine the weight loss and weight~     maintenance efficacy of an alternate day fasting-high protein (ADF-HP) diet; AIM 2: To~     examine the effects of an ADF-HP diet on metabolic disease risk factors (plasma lipids,~     fasting glucose, fasting insulin, insulin resistance).~   "
2946|NCT03528304|"~     A randomized controlled trial for the efficacy of contingency management to encourage smoking~     cessation and weight loss.~   "
2947|NCT03528291|"~     The purpose of this multicenter prospective study is to determine if the decision of~     transient circulatory support (TCS) in cardiogenic shock is relevant. TCS is a recommended~     treatment of refractory cardiogenic shock but precise indications are not definitively~     founded. Some studies described patients with TCS in order to establish mortality predictive~     scores (ENCOURAGE, SAVE), but no study has assessed the clinical relevance of the TCS~     decision yet. Therefore, The investigators propose to compare the characteristics and the~     follow-up of patients in acute cardiogenic shock, once TCS implantation was decided or not by~     the heart team.~   "
2948|NCT03528278|"~     The current research project aims at investigating whether it is possible to obtain an~     increase in physical activity among inpatients with schizophrenia spectrum disorders by the~     use of motivational interviewing and environmental interventions, and whether interventions~     will be associated with an increase in physical fitness and/or improvement in mental health.~     The Norwegian health care system operates with a catchment-area based organization, which~     make high levels of representability of patients possible. Patients will be recruited from~     intermediate-long term inpatient departments where patients typically have schizophrenia~     spectrum disorders and are admitted for longer periods. There are thus unique possibilities~     for coordinated efforts to motivate for and change dysfunctional habits.~   "
2949|NCT03528265|"~     Towards the goal of reducing melioidosis, this study will help clinicians in Sarawak to~     diagnose and understand the causes and risk factors for melioidosis. The data will help the~     clinicians to provide faster test results and better clinical care. The investigator's~     laboratory efforts will supplement available diagnostics by adding a new, easier-to-use test~     involving lateral flow immunoassay to rapidly detect Burkholderia pseudomallei, a bacterium~     causing melioidosis. The study aims to study up to 100 patients with melioidosis-like~     symptoms who are admitted to Kapit Hospital, Sarawak, Malaysia. No participants will be~     enrolled from other sites. The study will also examine the demographic, behavioral and~     occupational risk factors associated with hospital admissions to understand any existing~     associations between these variables and melioidosis prevalence.~   "
2950|NCT03528252|"~     This study investigates the effect of detailed, written dietary advice for improving blood~     lipids, in a primary care setting. n=222 participants will be randomized to Active~     Intervention or Control Group. After 3 weeks' intervention, participants will receive written~     feedback on the effect on their blood lipids. After 6 months, another blood sample is drawn~     and participants will receive further written feedback.~   "
2951|NCT03528239|"~     After Middle Eastern crisis, millions people were forced to migrate to European countries and~     especially neighboring countries. In Turkey, cities which are closed to east of border, face~     to cope more refugees' health care than those of other cities. The incidence of admission of~     hospital outpatient clinics and emergency department by refugee patients is not known clearly~     in our city, Nevsehir. In this study, we wanted to investigate use of health care among these~     patients in Nevsehir in Turkey.~   "
2952|NCT03528226|"~     Endothelial dysfunction and vasoreactivity disorders are early subclinical complications of~     type 1 diabetes (T1D). In a preventive setting, in T1D patients still free of complications,~     the research of non-pharmacological interventions to improve endothelial function appears~     fundamental.~      In this randomized controlled trial, the effects of exercise training on endothelial function~     will be evaluated in T1D adults. Secondary objectives are to evaluate the exercise training~     effects on the micro and macrovascular function and exercise-induced tissue vasoreactivity~     and their possible neurometabolic consequences.~      An improvement in vascular function, particularly endothelium-dependent, as well as in~     neurometabolic profile, through this non-pharmacological strategy is expected~   "
2953|NCT03528213|"~     ULIS-1 is an open-label pilot study concerning utility of molar sodium lactate in fluid~     balance in septic shock patients~   "
2955|NCT03528187|"~     Obesity and its related conditions account for up to 5%of all health care spending in the UK~     and this is expected to double by 2030. Following weight loss, significant improvement in~     these obesity-related illnesses has been reported. However, there is limited understanding of~     how these improvements happen and in particular, little dedicated work has been done using~     imaging in the obese population to look at the effects of treatment.~      Magnetic resonance imaging (MRI) is an imaging technique that allows assessment of fat~     concentration and volume without the use of ionising radiation. It is safe, non-invasive and~     well-tolerated by most patients.~      There are several MRI imaging techniques that be can used for fat quantification. These~     include MR spectroscopy and Dixon methods with measurement of fat fraction. These techniques~     measure the fat in the body organs and also the fat in the abdomen and skin. Recent technical~     developments mean that the whole body can be scanned relatively quickly (typically 30-40~     minutes).~   "
2956|NCT03528174|"~     The study described within this protocol is designed to test a single hormone closed-loop~     algorithm for managing blood glucose in type 1 diabetes using insulin only and a new device~     for measuring glucose continuously in the immediate vicinity of subcutaneous insulin~     delivery. Subjects will undergo one all day closed loop study using insulin only. The closed~     loop insulin only system includes a Dexcom G5 transmitter, a Nexus 5 smart phone and two~     Tandem tslim pumps connected to two Pacific Diabetes Technologies glucose sensing cannulas.~     The closed loop system will be started after G5 2 hour sensor start-up with an IV catheter~     for frequent blood withdrawal for 10 hours.~   "
2957|NCT03528161|"~     Syncope, a frequent reason for emergency room visits and hospitalization, is a symptom of~     three major etiological entities: cardiac causes, vaso-reflex causes and orthostatic~     hypotension. The etiological diagnosis is often uncertain and the prognostic assessment~     orients the outcome of the patient. The vast majority of syncope management costs are related~     to hospitalizations. Hospitalization in the immediate aftermath of emergency care is~     justified by a short-term prognosis. The current relevance of hospitalizations and the~     prognostic assessment of syncope is questioned.~   "
2958|NCT03528148|"~     To investigate the effects of elliptical cross bike exercises combine conventional physical~     therapy on gait, postural control, balance, muscle tone, spasticity, quality of life, motor~     functioning, functional activity, and ADL in post stroke patients.~   "
2959|NCT03528135|"~     The specific aims are to:~        1. Pilot test a randomized controlled trial of Project PRIDE for feasibility for subsequent~          research projects. A sample of 123 men aged 18-25 who identify as gay, bisexual, queer,~          or some other non-heterosexual identity, who are HIV negative, who report at least once~          instance of condomless anal sex in the absence of PrEP in the past 60 days, and who~          report drug use at least once in the past 60 days will be recruited and randomized to~          one of two conditions:~             1. Project PRIDE: an eight-session primary HIV-prevention intervention; or~             2. Wait-list control condition: after approximately 5 months, participants will~               receive Project PRIDE.~        2. Test the feasibility of obtaining biological measures of stress, drug use, and~          HIV/sexually transmitted infection (STI) status. To examine the impact of the~          intervention on stress physiology, participants will provide saliva samples that will be~          used to assess diurnal stress (i.e., cortisol) at pre-test, post-test, and 3-month~          follow-up. To substantiate self-report measures, participants will provide urine samples~          that will be used to assess drug use. Participants will be tested for gonorrhea, and~          chlamydia at each time point by providing a separate urine sample, HIV via oral swab and~          for syphilis by providing a blood sample.~        3. It is hypothesized that, compared to the wait-list control group, those in the treatment~          group will report significant reductions in mental health problems (depression, anxiety.~          loneliness), minority stressors (internalized homonegativity, sexual orientation~          concealment), substance use (drug and alcohol), condomless anal sex, number of sex~          partners, and stress-related biomarkers (salivary cortisol). In addition, compared to~          the wait-list control group, those in the treatment group will report significant~          improvements in self-esteem.~   "
2960|NCT03528122|"~     Macular hole surgery were tried by different surgeons using many techniques with different~     successes but still there were many recurrences. In this study the investigators try to close~     these distinct types including recurrent holes using pre-prepared amniotic membrane.~   "
2961|NCT03528109|"~     There is strong evidence that cognitive behavioral therapy (CBT) with exposure is the~     preferred treatment for youth with anxiety disorders, but outpatient services that provide~     this type of treatment are limited. Even for those who do have access to anxiety-specific~     treatment, a traditional outpatient model of treatment delivery may not be suitable. Among~     the numerous logistical barriers to treatment access and response is the inability to~     generalize treatment tools to settings outside of the office. Patient-centered (home-based)~     treatment models that target symptoms in the context in which they occur could be more~     effective, efficient, and accessible for families. The present study aims to compare the~     efficacy, efficiency, and feasibility of patient centered, home-based CBT with a traditional~     office-based model of care. The question proposed, including proposed outcomes, have been~     generated and developed by a group of hospital, payer, patient and family stakeholders who~     will also contribute to the iterative process of protocol revision. The investigators~     anticipate 333 anxious youth to be randomized to receive outpatient treatment using~     home-based services or treatment as usual using a traditional outpatient model. Results of~     this study are expected to provide evidence for the efficacy and efficiency of~     patient-centered treatment, as well as increase treatment access and family engagement in the~     treatment process.~   "
2962|NCT03528096|"~     This study aims to a) investigate the feasibility of the detection of episodes of RMD using~     contactless 3D video analysis and customised analysis software and b) the use of vestibular~     stimulation as a therapy for childhood rhythmic movement disorder.~   "
2976|NCT03527914|"~     Researchers believe that clinical care can be improved by engaging patients and families~     directly in planning the care process. Engagement efforts have included asking~     patients/families to provide information about whether they are getting better. But what does~     getting better mean? The merits of surveys, questionnaires, or rating scales have been~     widely discussed. Should they be disorder-specific or global? What should the investigators~     do if patients have difficulty reading or understanding these instruments? Investigators in~     the United Kingdom have proposed a simple solution: ask the patients and families what their~     primary goal treatment goal is and track progress together on that goal (Goal-Based Outcomes~     or GBO). Although there has been some work to suggest that this is helpful, it has never been~     tested in a controlled way. This study will do a special type of randomized controlled trial~     to test whether GBO improves clinical care in child and youth mental health. Although the~     study will use this in child and youth mental health care, if it is successful, it can be~     tested and applied in any care setting with any type of medical problem. This could change~     practice at the Children's Hospital of Eastern Ontario (CHEO) and throughout Canada.~   "
2963|NCT03528083|"~     Bronchiolitis is a respiratory illness characterized by acute inflammation of the airways,~     typically caused by a virus. By definition, it impacts children between 2 months and 2 years~     of age and is the most common cause of hospitalization among infants in the first year of~     life (American Academy of Pediatrics). Children with this illness may exhibit respiratory~     distress, as well as symptoms of viral respiratory illness, such as sneezing, nasal~     congestion, and cough. Often, hospitalization is required for respiratory distress and to~     support hydration needs.~      Evidence based guidelines for the treatment of acute viral bronchiolitis primarily involve~     supportive care, which most often includes supplemental oxygen, hydration, and suctioning of~     secretions. However, in practice, bronchiolitis care is highly variable, often involving~     therapies such as inhaled bronchodilators, systemic corticosteroids, inhaled hypertonic~     saline, continuous pulse oximetry, chest physiotherapy, antibacterial medications, and use of~     intravenous fluids, all of which have been shown to be unnecessary and costly. Unnecessary~     care remains although multiple published quality improvement studies centered on acute~     bronchiolitis have proven successful. Quality improvement interventions have shown reduced~     use of unnecessary treatments and reduced resource allocation. Therefore, the investigators~     will conduct a quality improvement process to improve adherence to bronchiolitis treatment~     guidelines for children with bronchiolitis treated at University of California Davis~     Children's Hospital.~   "
2964|NCT03528070|"~     56 patients with sarcoidosis will be selected to receive treatment of tranilast.The~     investigators can analyse the changes in the thickness and area of skin lesions before and~     after treatment as well as other involved organs nodule size changes to determine the~     efficacy and safety of drugs.~   "
2965|NCT03528057|"~     The aim of this study is to evaluate whether Hemostatic Agents (HA) make a significant~     clinical difference in patient outcomes when used for Robotic-Assisted Laparoscopic Partial~     Nephrectomy (RALPN). The result of this trial will determine whether HAs are necessary for~     use during RALPN or if they can be omitted from the surgical tools available during this~     procedure. This study has a direct clinical implication on a patient's outcomes following~     RALPN, specifically whether patients will have better, worse, or unchanged outcomes with~     RALPN if HAs are used.~   "
2966|NCT03528044|"~     This research investigates obesity and associated psychiatric symptoms and disorders in a~     wide range of perspectives, to demonstrate the effects of obesity on the brain. The 1st aim~     is to assess the psychiatric symptom profiles in the group of obese patients applying for~     bariatric surgery and to determine the associated environmental stress factors. While, it is~     known that eating disorders, mood disorders and psychiatric drugs can cause obesity, obesity~     can also cause many psychiatric complications such as depression and cognitive disorders.~     There are no multi-centered studies that are conducted in this respect, and the guidelines on~     pre-evaluation and follow-up of patients are also lacking. The 2nd aim is to evaluate and~     monitor cognitive characteristics before and after bariatric surgery in obese patients. Obese~     people are at increased risk of dementia and are more likely to have cognitive deficits,~     especially executive function problems, that can affect everyday life. For this reason, obese~     individuals should be examined and monitored in more detail in terms of their cognitive~     characteristics and the change of cognitive functions during the weight loss process. The 3rd~     aim is to examine the relationship between obesity, bariatric surgery and reward processing~     system. Studies have been limited in determining whether addiction in these people is due to~     a search of a continuous substance as a cognitive feature or whether it is difficult to~     terminate it as an impulsive behavior when encountered with a pleasurable substance, even~     though there is no reward seeking or reward dependence. The 4th aim is the determination of~     the neuroanatomical and molecular components of cognitive changes observed after bariatric~     surgery. During the dynamic process following bariatric surgery, a variety of metabolites,~     chemokines, and microbiota changes may also affect the brain health and cognition. The 5th~     aim is to determine factors of eating, emotional regulation, reward system, addiction and~     impulsivity, and other psychopathologies that cause suboptimal weight loss or weight gain~     after bariatric surgery. Understanding the psychological and neurobiological factors involved~     in these processes can improve surgical interventions and significantly increase the quality~     of life for patients.~   "
2967|NCT03528031|"~     The Habitual Diet and Avocado Trial will evaluate the effects of providing one avocado per~     day for recommended consumption over a 6 month period in a cohort of approximately 1000~     free-living participants with increased waist circumference in comparison with a control~     group that will maintain their habitual diets. Participants will be recruited and screened at~     4 clinics in 4 locations: Pennsylvania State University; Loma Linda University; UCLA, and~     Tufts University (250 per site).~   "
2968|NCT03528018|"~     Rehabilitation options for stroke survivors who present severe hemiparesis in chronic stages~     are limited and may end in compensation techniques that involve the use of the less affected~     arm to achieve some degree of functional independence. Transcranial direct current~     stimulation (tDCS) is a non-invasive technique that has been used after stroke to promote~     excitability of the surviving neural architecture in order to support functional recovery.~     Interestingly, cortical excitability has been reported to increase when tDCS is combined with~     virtual reality. This synergetic effect could explain the promising results achieved by~     preliminary experimental interventions that combined both approaches on upper limb~     rehabilitation after stroke. The objective of this study is to explore the use of these~     interventions in subjects with severe hemiparesis and to determine its efficacy in comparison~     to conventional physical therapy~   "
2969|NCT03528005|"~     This project aims to examine the effectiveness of the community-based integrated care service~     model , based on a multi-domain intervention program, among community-dwelling older adults.~     Moreover, the investigators use the value-based healthcare standard set as well as~     comprehensive geriatric assessment as outcome measures and to use the randomized controlled~     trial design to validate the clinical effectiveness.~   "
2970|NCT03527992|"~     Hypoxemic pneumonia is a major cause of hospitalization in Pulmonology. The patient's~     dependency on oxygen prevents early discharge from the hospital. An automated oxygen therapy~     is a system that allows administration of oxygen with a flow that is automatically adjusted~     to the patient's saturation, which is continuously monitored. This system has proven to be~     particularly effective with chronic obstructive pulmonary disease (COPD) patients, by~     decreasing the time spent in hypoxia and hyperoxia, and by accelerating the weaning of~     oxygen. Our hypothesis is that automated oxygen therapy leads to a diminution on the length~     of hospital stay.~   "
2971|NCT03527979|"~     the polycystic ovarian syndrome is associated with an ovulation and infertility. recently the~     laparoscopic ovarian drilling has been used as surgical treatment for ovulation in women with~     polycystic ovarian syndrome, although its mechanism and outcomes are still unclear. this~     study is undertaken to evaluate the in vitro fertilisation outcomes in clomiphene-resistant~     women with PCOS who were treated with LOD.~   "
2972|NCT03527966|"~     This study is aimed at comparing the overall efficacy (clinical and radiographic) of Vivigen,~     a novel cellular allograft product, and rhBMP-2 when utilized in lumbar fusion procedures.~   "
2979|NCT03527875|"~     The purpose of this study is to evaluate the safety and effectiveness of different methods of~     preoperative biliary drainage in hilar cholangiocarcinoma patients, including PTBD~     (Percutaneous Transhepatic Biliary Drainage), ENBD (Endoscopic Nasobiliary Drainage) and EBS~     (Endoscopic Biliary Stenting).~   "
2980|NCT03527862|"~     The investigators evaluate the usefulness of lung ultrasonography in the perioperative period~     for postoperative outcomes in children undergoing fast track cardiac surgery.~   "
2981|NCT03527849|"~     The purpose of this study is to see if stress reduction can lead to less pain due to knee~     osteoarthritis. To do this the investigators will compare two types of stress reduction~     modalities, Mindfulness-Based Stressed Reduction (MBSR) and a Health Enhancement Program~     (HEP). Both include stress reduction techniques, but MBSR has a mindfulness component that~     includes meditation. MBSR will be provided either in-person or online and HEP will be~     in-person. The assignment to the stress reduction program will be determined by the Principal~     Investigator. In order to assess for stress reduction and pain reduction the investigators~     will use validated measuring tools before, during, and after the course instructions.~   "
2982|NCT03527836|"~     The doses of local anesthetics can be decreased with the use of ultrasound guidance. In case~     of using mixture solutions the benefits and drawbacks are controversial. The plasma~     concentrations were not studied up to this time in this kind of settings, so investigators~     believe that this is the first work that shows how lidocaine change the plasma concentration~     of bupivacaine after axillary approach to brachial plexus employed with different dilute and~     mixed solutions for upper limb surgery in trauma patients.~   "
2983|NCT03527823|"~     In Zeynep Kamil Women and Children's Education and Research Hospital which is a tertiary~     referral hospital, the investigators perform microdose flare-up gonadotropin-releasing~     hormone (GNRH) analogue or GNRH antagonist protocol to the poor responders. The investigators~     may or may not supplement luteinizing hormone (LH). Human chorionic gonadotropin (hCG)~     triggering is performed when at least 2 follicles diameter are above 17 mm and the serum~     estradiol level is above 500 pg / ml. 36 hours after hCG, ovarian aspiration is performed by~     the guidance of transvaginal ultrasound. Normally after oocyte separation process, the~     remaining follicle aspiration fluid is destroyed.~      n the present study, the follicle aspiration fluid is planned to be used with the patient's~     permission. The investigators are going to examine the granulosa cell apoptosis rate by using~     annexin-5 antibody in both groups 1 (LH added) and 2 (without LH).~      For this purpose, a total of 40 volunteer patients are planned to involve, the groups are~     designed as 20 LH added and 20 LH added women.~      In the present study, the investigators hypothesis that the rates of granulosa cell apoptosis~     in poor responders may be different between the group 1 (with LH) and group 2 (without LH),~     this will lead to IVF therapy in the near future.~   "
2984|NCT03527810|"~     The subject will undergo standard pre-operative preparation. Subjects will be evaluated for~     the presence of bothersome GERD symptoms by GERD questionnaires and use of PPI medications.~     Those eligible will be approached at their preoperative appointment about participation in~     the study and consent will be reviewed with subject. Signed consent will be collected from~     the subject prior to entry into the operating room. After induction of anesthesia, the~     subject will be randomized to sleeve gastrectomy with or without interrogation of the hiatus.~      The SG will be performed as per standard approaches already described. In those randomized to~     interrogation, the hiatus will be opened posteriorly with preservation of the~     phreno-esophageal ligament where possible, as per standard described techniques. Dissection~     into the mediastinum will be stopped if no hernia is seen or when appropriate intra-abdominal~     length of 2 cm of esophagus is created. Once opened, the Hiatal Surface Area (appendix B)17~     will be measured, calculated and recorded and when possible, a photo taken of the area.~     Repair of the crura will then be performed around the sizing tube used to create the sleeve~     with enough space to allow a 5 mm instrument to be easily inserted. Permanent sutures will be~     placed posterior to the esophagus.~      Subjects will be recovered and be discharged per standard protocol. Evaluation for reflux~     will be conducted pre-operatively and then 3, 6, 12 and 24 months (+/- 30 days) after surgery~     or on demand if symptoms occur between follow up periods. Many groups advocate the use of PPI~     for the first 30 days after bariatric surgery - accordingly assessments of reflux will not~     occur until 3 months post operatively when most groups stop prophylactic PPI use. A visit~     within the first 30 days after surgery (+/- 15 days) should occur to evaluate for potential~     complications of surgery.~   "
2985|NCT03527797|"~     Due to an accident, pneumonia or surgery, patients can have severe shortness of breath or~     lung damage to such an extent that it compromises vital functions. At such times, mechanical~     ventilation can be lifesaving. The ventilator temporarily takes over the function of the~     respiratory muscles to ensure adequate uptake of oxygen and removal of carbon dioxide.~     Mechanical ventilation can usually be stopped quickly after the initial disease has been~     treated. Unfortunately, in up to 25-40% of ventilated patients it takes several days to weeks~     before mechanical ventilation can be discontinued, even after treatment of the initial~     disease. This phenomenon is termed weaning failure. Weakness of the respiratory muscles, such~     as the diaphragm, is one of the leading causes of weaning failure.~      Like other skeletal muscles, the diaphragm can become weakened if it is used too little. This~     happens often during mechanical ventilation because of excessive assistance provided by the~     ventilator or use of sedative medication. Excessive activity of the diaphragm can also lead~     to damage and weakness, just like in other muscles that have to perform excessive amounts for~     a prolonged period of time. Additionally, excessive work by the diaphragm might have a direct~     damaging effect on the lungs, which leads to a vicious cycle. As such, it is very important~     to find a balance between resting the diaphragm (which may lead to weakness) and placing~     excessive work on the diaphragm (which can damage the diaphragm and possibly the lungs).~      In this study, the investigators want to test whether insufficient activity and excessive~     activity of the diaphragm during mechanical ventilation can be prevented or reduced. The~     investigators plan to measure the diaphragm activity in 40 participants on mechanical~     ventilation. Participants will be randomly assigned to the intervention group or the control~     group. In the intervention group, ventilator support levels will be adjusted according to the~     observed diaphragm activity, in an attempt to ensure adequate diaphragm activity. The control~     group receives usual care. The hypothesis is that adjusting the level of support provided by~     the ventilator is a feasible method to improve the time that the diaphragm operates within~     acceptable levels of activity over a 24 hour period.~   "
2986|NCT03527784|"~     Prestoma Trial is designed to compare the safety and efficiency of three different meshes and~     techniques to prevent parastomal hernia after laparoscopic or robotic-assisted~     abdominoperineal resection for rectal adenocarcinoma.~   "
2987|NCT03527771|"~     Technical advance as broad-bandwidth wireless internet coverage and the ubiquity utilization~     of smartphones has opened up new possibilities which surpass the normal audio-only telephony.~     High quality and real-time video-telephony is now feasible. However until now this technology~     hasn't been deployed in the emergency respond service.~      In the hope of helping the detection of the cardiac arrest, offer the possibility to evaluate~     and correct via a video-instructed CPR (V-CPR) and to facilitate a fast localization of the~     emergency site, a new software (EmergencyEye®/RAMSES®) was developed which enables the~     dispatcher a video-telephony with the callers mobile terminal (smartphone) if suitable.~      This technology hasn't been tested in a randomized controlled trail yet and no data exists~     that shows if V-CPR in comparison to T-CPR and non-instructed CPR leads to a better bystander~     CPR-performance.~   "
3640|NCT03519217|"~     Diabetes mellitus is a group of metabolic diseases characterized by chronic hyperglycemia~     resulting from defects in insulin secretion, insulin action, or both.~   "
2988|NCT03527758|"~     Intraoperative hypotension (defined as mean arterial pressure below 65 mmHg) is associated~     with increased organs dysfunction and mortality. Even short durations of reduced arterial~     blood pressure episodes significantly increased the risk of myocardial injury, neurological~     deficits, renal failure, and mortality. Hypotension rate during surgery is quite common and~     recent studies showed an incidence up to 60% of patients endured hypotension during~     anesthesia for an average of 10% of surgical time.~      Nowadays hypotension seems to be preventable even if current management of the hypotensive~     episodes is predominantly reactive and rather occurs with some delay.~      The investigators hypothesize that the prevention of hypotension by means Edwards~     Lifesciences new technology (HPI software) can improve patients outcome after surgery.~      The present pilot randomized clinical trial is aimed at investigating various biomarkers~     involved in organ dysfunction and how they correlate with different intraoperative~     hypotension management strategies (Invasive blood pressure monitored by a normal arterial~     line vs Invasive blood pressure monitored by Edwards FloTracIQ system with HPI software).~   "
2989|NCT03527745|"~     This study is a single-blind randomized clinical trial conducted in rural Côte d'Ivoire. This~     study aims at providing evidence on the dose-response of increasing oral albendazole dosages~     against whipworm (T. trichiura) and hookworm infections in preschoolers (2-5 years),~     school-aged children (6-12 years) and adults (≥ 21 years).~      The primary objective is to determine cure rates (primary end point, i.e. conversion from~     being egg positive pre-treatment to egg negative post-treatment). Secondary objectives~     involve the determination of egg reduction rates (the reduction in the number of excreted~     eggs from baseline (prior to treatment) to follow-up) and the assessment of safety of~     ascending dosages of albendazole (secondary end points). In addition, key pharmacokinetic~     parameters will be determined from blood samples collected with a micro-sampling device~     (secondary end point).~   "
2990|NCT03527732|"~     This study is a double-blind randomized clinical trial conducted with two settings in Africa~     and one in Asia, namely Côte d'Ivoire, Pemba (Zanzibar, Tanzania) and Lao PDR. This study~     aims at providing evidence on the efficacy and safety of co-administered albendazole and~     ivermectin versus albendazole monotherapy (standard of care) against whipworm (T. trichiura)~     infections in children and adults (6-60 years).~      The efficacy of the treatment and potential extended effects on follow-up prevalence will be~     determined 14-21 days, 6 months and 12 months post-treatment by collecting another two stool~     samples. The cure rate will be calculated as the percentage of egg-positive subjects at~     baseline who become egg-negative after treatment.~   "
2991|NCT03527719|"~     China Rural Hypertension Control (CRHC) Project is a cluster randomized trial which will test~     the effectiveness of a standardized protocol-based treatment program on hypertension control~     and cardiovascular events among hypertensive patients in rural China.~   "
2992|NCT03527706|"~     To identify predictors for postoperative health related quality of life after elective~     sigmoidectomy for diverticular disease.~   "
2993|NCT03527693|"~     The study aims to evaluate the effects of a single intra-articular injection of~     micro-fragmented adipose tissue obtained with the Lipogems® system in patients affected by~     knee chondropathy. End-points were determined by evaluating the patients in terms of~     improvement in symptoms, functional recovery and radiographic appearance compared to~     baseline.~   "
2994|NCT03527680|"~     Uremic toxins such as p-cresol and phenol are suggested to be associated with higher~     mortality in hemodialysis patients. The aim of this study was to investigate the effects of~     probiotics on serum p-cresol level in hemodialysis patients.~   "
2995|NCT03527667|"~     This pilot study aims to test the feasibility of providing incentives to patients with T2D~     contingent on remote biochemical verification using a smartphone carbon monoxide (CO)~     monitor. The investigators will use an ecological momentary assessment (EMA) smartphone~     application and CO sensor to monitor urges to smoke, stressors, smoking behaviors, and to~     validate continuous abstinence throughout the intervention. Two different contingency~     management structures will be explored to investigate the length of time incentives need to~     be offered.~   "
2996|NCT03527654|"~     Hispanic immigrants to the U.S. are more likely to experience negative health outcomes the~     longer they live in the U.S. For example, over time Hispanic immigrants engage in riskier~     behaviors such as substance abuse, violence, and risky sex, and experience more depressive~     symptoms. The stress associated with the acculturation process, acculturation stress, and~     resilience at the individual, family, community, and societal levels appear to play important~     roles in influencing risks. However, little is known about the causal mechanisms linking~     acculturation stress, resilience, and health outcomes among Hispanic immigrants. Further,~     little is known about what precise types of stressors (e.g., occupational stress vs.~     discrimination) and resilience factors (e.g., individual coping vs. family support) have the~     most important influence on health trajectories of Hispanic immigrants. The proposed~     longitudinal study (N = 385) will investigate the effects of acculturation stress and~     resilience on co-occurring substance abuse, intimate partner violence, HIV risk, and~     depression (i.e., syndemic conditions) and biological stress among young adult Hispanic~     immigrants in the U.S. More specifically, the proposed project aims to: 1) test theoretical~     links between the cumulative impact of acculturation stress and resilience on syndemic~     conditions and biological stress among recent young adult Hispanic immigrants over a two-year~     period, and 2) identify the specific types of acculturation stressors and resilience factors~     at the individual, family, community, and societal levels that are most important in~     predicting syndemic conditions and biological stress among this population over time. Young~     adult low-income Hispanic immigrant men and women within the first 10 years of immigration~     will be followed for two years. Biopsychosocial data will be collected from participants at~     baseline, and then 6 months (FU1), 12 months (FU2), 18 months (FU3), and 24 months later~     (FU4). Culturally specific measures of acculturation stress and resilience will be used to~     assess for individual, family, community, and societal risk and protective factors for~     syndemic conditions. Blood and urine samples will be obtained from participants to measure~     systemic inflammation (IL 6, IL8, and IL 18) and oxidative stress (F2 isoprostanes),~     previously validated biomarkers for psychological stress. Various descriptive, univariate and~     multivariate statistics, including latent growth curve modeling, will be used to address aims~     1-2. The findings from this study have the potential to identify risk and protective factors~     for the decay in heath among Hispanic immigrants. A precise and culturally informed~     understanding of these phenomena is foundational for designing interventions that can~     ultimately promote the health and wellbeing of Hispanic immigrants, the largest immigrant~     group in the U.S. This study also has the potential to lay the theoretical foundation for~     biopsychosocial health disparities research in other populations.~   "
2997|NCT03527641|"~     This study pilots the feasibility and acceptability of a family-based lifestyle intervention~     for decreasing diabetes risk called Salud sin Barreras (meaning, Health without Barriers)~     delivered in the community to Latino teens at risk for type 2 diabetes. This program combines~     traditional lifestyle intervention to change eating and physical activity with learning~     mindfulness-based stress reduction tools. We also are exploring how Salud sin Barreras lowers~     stress and improves insulin resistance in Latino teens, as compared to lifestyle-only~     intervention, the La Vida Saludable (meaning, the Healthy Living Program; HeLP).~   "
2998|NCT03527628|"~     This is a prospective, multi-center, open-label, phase II clinical trial, aims to assess the~     effectiveness of the combination ACVD (Adriamycin, Cyclophosphamide, Vinblastine and~     Dacarbazine) and BV (Brentuximab Vedotin) in PET-2 positive advanced-stage HL patients, in~     order to improve the overall long-term disease control in the entire cohort of advanced-stage~     HL.~   "
3002|NCT03527576|"~     It has been largely demonstrated that iv dexamethasone prolongs the duration of analgesia~     after peripheral nerve block. However, data are missing regarding the duration of analgesia~     after spinal block. The objective of this randomized controlled double-blinded trial is to~     assess whether intravenous dexamethasone administered after a spinal block, before the~     surgery would prolong sensory block characteristics without impacting the motor block~     duration.~   "
3003|NCT03527563|"~     The study is a multi-center, randomized, open, and parallel study. Approximately 958 subjects~     will be enrolled in 16 sites. The random number table will be adopted to conduct cluster~     randomization per township hospital/community health service center. Patients will be~     randomized 1:1 to receive blood pressure management in Internet medical model or Conventional~     medical model. After follow-ups of 3 months and 6 months, the blood pressure in each group~     will be observed and compared.~   "
3004|NCT03527550|"~     This study is designed to test whether computer-based cognitive exercises are helpful for~     reducing a specific type of impulsivity. Also, the study is testing whether these are~     exercises are associated with specific changes in behavior and in the brain. Participants~     will be psychiatric patients enrolled in a partial hospitalization program. Half of these~     participants will receive usual treatment, and half will complete computer-based cognitive~     exercises in addition to usual treatment.~   "
3005|NCT03527537|"~     The goal of this study is to compare two different thresholds for initiation of medical~     treatment for GDM. Pregnant women diagnosed with GDM will be randomized to either start~     pharmacotherapy when they have reached at least 20% or at least 40% of capillary blood~     glucose (CBG) values above the target goal. The investigators hypothesize that a lower~     threshold of 20% elevated CBG levels, compared to 40%, will lead to lower rates of obstetric~     and medical complications.~   "
3006|NCT03527524|"~     The purposes of this study are to compare the effects of core stabilization exercises on pain~     intensity, functional disability and lumbar stability between using and not using the Swiss~     ball in patients with non-specific chronic low back pain.~   "
3007|NCT03527511|"~     The optimal management of mineral and bone disorders associated to chronic kidney disease~     (CKD-MBD) is a daily challenge for nephrologists. Its consequences may be immediate~     (biological abnormalities such as hypocalcemia, hyperphosphatemia, hyperparathyroidism, etc.)~     or delayed (fractures, renal osteodystrophy, vascular calcifications, increased~     morbi-mortality and growth retardation in the youngest patients). CKD-MBD is defined by the~     association of one or more of the following abnormalities: 1/ disturbances in calcium,~     phosphate, PTH or vitamin D metabolism, 2/ bone and growth abnormalities, and 3/~     calcifications of vessels or soft tissues .~      Three main bone characteristics can be modified by CKD, namely turnover, mineralization and~     volume. They should therefore be carefully assessed to distinguish between the different~     sub-types of renal osteodystrophy, as defined in the 2006 K-DIGO guidelines on the TMV~     classification . The primary bone lesion in pediatric CKD, at least in pediatric patients~     reaching end-stage renal disease without any previous management, is the~     high-turnover/hyperparathyroidism, because of high circulating PTH levels with low 1-25~     vitamin D levels. Conversely, low turnover (or adynamic bone) may be observed in dialysis~     children receiving too much calcium and/or vitamin D analogs. All these lesions are~     deleterious on the long-term, increasing both the risk of growth retardation, fractures and~     vascular calcifications .~      In order to better understand the complex pathophysiology of renal osteodystrophy, biomarkers~     of bone and phosphate/calcium metabolism may be used, but their interpretation may be~     challenging in the context of CKD. The gold standard remains bone biopsy at the iliac crest~     with histomorphometry, but it is rarely performed in Europe .~      The research team of this study has developed and validated a unique non-invasive technique~     to differentiate circulating human monocytes into mature and functional osteoclasts, using~     only 15 mL of total blood (instead of conventional techniques they used to use, with 200 to~     250 mL of total blood). They propose to use this innovative tool in the specific setting of~     CKD.~      The current management of CKD-MBD consists mainly of correcting native vitamin D deficiency,~     decreasing phosphate levels (using nutritional management and phosphate-binders), and~     decreasing PTH levels (using active vitamin D, calcimimetics such as cinacalcet and~     etelcalcetide, and/or surgical parathyroidectomy) . Active vitamin D analogs and~     calcimimetics are cornerstone of this management.~      The first working hypothesis is the following: when CKD progresses and glomerular filtration~     rate (GFR) decreases, 1-25-D is able to inhibit osteoclastic differentiation, however to a~     lesser extent to what is observed in healthy controls with normal renal function.~      The second working hypothesis is therefore the following: etecalcetide could be an inhibitor~     of osteoclastic resorption and a stimulator of osteoblastogenesis. When CKD worsens and GFR~     decreases, etelcalcetide inhibits osteoclastic differentiation, however to a lesser extent to~     what is observed in subjects with normal renal function.~      Aims In Vitro~        1. Effects of 1-25-D and etecalcetide on human osteoclastogenesis and osteoclastic~          resorption (in cells obtained from CKD patients at different stages of CKD)~        2. Effects of 1-25-D and etecalcetide on murine osteoblastogenesis and mineralization~   "
3008|NCT03527498|"~     There is no international application of infant running stimulation system to evaluate the~     brain injury in children with various stages of nerve and motor development in a large sample~     of studies. The study of neonatal brain injury is only limited to intraventricular~     hemorrhage(IVH),periventricular leukomalacia(PVL), Down's syndrome(DS), premature birth of~     these four conditions, and the number of samples in the single digits, there is no~     representative of the disease population. Therefore, from the newborn to the infant~     development of the critical period, the investigator will refer to the previous treadmill~     parameters set on the research results, optimize the application of neonatal treadmill. The~     study hypothesized that neonatal treadmill stimulation with brain-injured children could~     improve his / her staggered gait characteristics and long-term nerve development through~     large sample data. It is important to preserve and analyze the gait characteristics and the~     changes of nerve development in every stage of growth and development of neonates with brain~     injury so as to provide clinical evidence for rehabilitation intervention. It is of great~     significance to judge whether this technique can be used in the early stage of brain injury~     in neonates.~   "
3009|NCT03527485|"~     This study aims to measure synaptic density in the brains (including in ventral striatum [VS]~     and medial prefrontal cortex [mPFC]) of abstinent subjects with Cocaine Use Disorder (CUD) or~     Opiate Use Disorder (OUD) as compared to healthy control (HC) subjects using 11C-UCB-J PET.~     Subjects will undergo a single 11C-UCB-J (also known as 11C-APP311) PET scan.~      This would be the very first to image synaptic density in human cocaine and opiate users,~     thereby testing whether altered synaptic density in the rodent brain is recapitulated in CUD~     and OUD humans. If confirmed, the current study would provide compelling~     clinical-translational support for an important pathophysiological mechanism of addiction -~     aberrant structural synaptic plasticity. As such, the current study has considerable~     potential for advancing the neurobiological understanding of human cocaine and opiate~     addiction.~   "
3010|NCT03527472|"~     A phenome-wide association study (PheWAS) identified an association between a variant in the~     human gene for the N2A subunit of the N-methyl-D-aspartate (NMDA) receptor, GRIN2A, and~     Systemic Lupus Erythematosus (SLE). A single nucleotide polymorphism (SNP) in this gene~     encodes for increased NMDA receptor activity. Based on the potential function of the~     associated SNP and published literature, alterations in SNP function signaling may underlie a~     cluster of symptoms. The objective of this study is to evaluate the safety, tolerability and~     efficacy of memantine, an NMDA receptor antagonist, in a precise patient subset with SLE.~     Participants will complete a full 14-week clinical trial, receiving either memantine or a~     placebo. Participants' blood will be drawn to test for various antibodies as well as organ~     function. Patients' urine will also be collected to assess organ function and pregnancy for~     females at a number of specific time points. The overall goal is to develop a safe and~     inexpensive therapeutic approach to reduce debilitating cognitive symptoms in a precisely~     selected SLE sub-population.~   "
3011|NCT03527459|"~     The purpose of this project is to evaluate a set of interventions derived from a theory of~     suicide that supplements a clinical program and compare their effects on outcomes to the~     outcomes of the unsupplemented program. This study proposes to evaluate the effect of these~     interventions on reducing specific negative cognitions associated with depression and suicide~     ideation in an intensive outpatient program for suicidal youth (Suicide Prevention and~     Resilience at Children's, SPARC).~   "
3012|NCT03527446|"~     Regular exercise is a cornerstone in the prevention and the management of cardio-metabolic~     risk factors. Some of the beneficial effect of exercise training occurs through metabolic~     flexibility' enhancement. Metabolic flexibility is the ability to respond or adapt to~     conditional changes in metabolic demand, and previous literature has shown that individuals~     living with obesity have an impaired metabolic flexibility compared to lean individuals.~     However, there is a lack of empirical evidence on the impact of sprint interval training on~     metabolic flexibility and whether this translates into clinically meaningful outcomes.~      This study will evaluate the impact of 4-week sprint interval training in normal weight~     individuals as well as individuals living with obesity on acute and chronic metabolic~     flexibility, irisin secretion and insulin sensitivity.~   "
3641|NCT03519204|"~     This study will evaluate the safety and effectiveness of VOLBELLA with Lidocaine injectable~     gel in Chinese adults seeking lip enhancement.~   "
3013|NCT03527433|"~     Wound complications, increased hospital stays and post-operative morbidity are all common~     following abdominal surgery. Abdominal closure complications are strongly associated with the~     closure technique and material used. The traditional closure technique used by surgeons is~     placing the wide and large stitches. A randomized controlled trial done in Sweden described a~     new closure technique in surgeries by placing the stitches closer to each other by using~     narrow. The results showed lower incidence of wound infections, hernias, and wound rupture.~     However, the study provides low quality evidence on the benefits of this new technique since~     it has numerous limitations like lack of standardization of suture size, lack of proper~     randomization, and heterogeneity in patient eligibility which will increase result bias.~     There is still a need for quality evidence on the effectiveness of this new closing technique~     procedure at decreasing wound complications after the operation.~      In this trial the investigators will compare two techniques in the closure of abdominal~     wounds in patients undergoing abdominal surgery. The first technique will be the traditional~     closure technique currently used in abdominal surgery. The second technique will be using the~     new closure technique. The closure of abdominal wounds with small and close sutures using the~     new technique is expected to lower the incidence of hernia and wound complications as well as~     improve the quality of life of the patient. Potential candidates for the study are those who~     will be undergoing elective midline laparotomy at AUBMC. The patients and assessor of~     outcomes will be blinded and patients will be randomized to receive either the traditional or~     new closure operation technique. There are no anticipated risks for those participating in~     the study. All data and information collected will be kept confidential.~      Hypothesis:~      Closure of abdominal fascia in elective midline laparotomy incisions with small and close~     sutures compared to closure with conventional wide and distant sutures results in lower rates~     of wound rupture, incisional hernia, and wound infection, and improved quality of life.~      Significance:~      The results of this study will allow surgeons to assess the role of a new abdominal closure~     technique in decreasing short and long term postoperative complications, for a commonly~     performed procedure. This trial will generate evidence-based conclusions.~   "
3014|NCT03527420|"~     The main objective is to examine DNA hypomethylation as an underlying mechanism for the~     increased production of inflammatory cytokines and the impaired vascular function in obese~     individuals and as a potential target for nonpharmacological preventive/therapeutic~     interventions such as aerobic exercise.~   "
3015|NCT03527407|"~     Swiss legislation requires health service providers to collect such information. of medical~     quality indicators as part of the quality and performance audit (Article 22a KVG). In~     addition, comparisons of clinics or specialist specialists on cost and quality of results are~     required (Art. 49 (8)).~      Currently, the quality of a medical therapy is evaluated rather negatively on the absence (or~     occurrence) of complications. In contrast, however, the goal of therapy must be to improve or~     maintain the health-related quality of life (HRQoL). Accordingly, the Swiss Society of~     Surgery (SGC-SSC), in collaboration with the Association for Quality Assurance in Surgery~     (AQC), has developed a minimum dataset designed to assess the quality of life of patients~     after surgical intervention. In order to enable Switzerland to be comparatively independent~     of the discipline, generic (in the Research Plan - MIDAS -V2, date 24.05.2017 Page 5/57~     Contrary to disease-specific) survey instruments proposed that cover the general quality of~     life in its different facets, regardless of the function of individual organ systems. The~     complication documentation was not completely abandoned in this proposal, but is only a~     quality indicator among many due to patient-related outcome measurements.~      However, the development of a minimal data set with quality indicators that are applicable~     across all surgical sub-disciplines for evaluating the quality of treatment of acute and~     chronic diseases raises a number of fundamental questions that can only be answered to a~     limited extent without empirical studies. Five essential questions are:~      I. Is it sufficient to work with generic quality of life tools or is it necessary to use~     disease / indication specific instruments or functional tests? II. Which is the best, solid~     time for a follow-up? III. Is it possible and useful to make a third-party determination of~     the quality of life in patients with limited cognitive abilities? IV. Which preoperative risk~     factors should be documented so that sufficient adjustment for case mix differences in~     hospital comparisons can be made? V. Which perioperative and postoperative factors, in~     particular complications, must be raised beyond the quality of life, as they reflect an~     independent aspect of quality?~   "
3016|NCT03527394|"~     Approximately one-third of Canadian children have excess weight, putting them at increased~     risk of type 2 diabetes, cardiovascular disease, bone and joint problems, and some forms of~     cancer. Because current therapies for managing obesity have modest success, there is a need~     to develop and test innovative strategies to enhance pediatric weight management. Using a~     novel interview designed to measure motivation to change lifestyle habits, interviewers will~     conduct separate and structured 1-on-1 interviews with youth with obesity and parents. By~     applying principles of motivational interviewing, trained interviewers will ask youth and~     their parents about their motivation to change lifestyle habits related to diet and physical~     activity. Subsequently, interview data will be used to examine predictors of~     clinically-meaningful outcomes over time, including changes in weight status, lifestyle~     habits, health care utilization, and attrition. The investigators will also measure a number~     of variables related to weight management, including dietary intake, physical activity,~     anthropometry, and psychosocial health.~   "
3017|NCT03527381|"~     This prospective randomized study evaluates the nephroprotective effects of exogenous nitric~     oxide delivered to the extracorporeal circulation circuit during cardiac surgery with~     cardiopulmonary bypass.~   "
3018|NCT03527368|"~     TRIM is a randomized, controlled feeding study to evaluate if eating earlier in the day vs.~     later in the day impacts weight and glucose homeostasis.~   "
3019|NCT03527355|"~     This is a randomized, observer-blinded Phase 2 study in healthy infants and toddlers 6-23~     months of age at the time of the first vaccine dose.~      The purpose of this study is to assess the safety and immunogenicity of the Vi-DT vaccine in~     age group 6-23months of age.~      The Vi-DT vaccine is administered at 25 µg either as a single dose, or two doses given 6~     months apart.~   "
3020|NCT03527342|"~     This is a joint project by Sahlgrenska University Hospital: Sahlgrenska, Östra and Mölndal.~      Our objective is to diagnose and map patients with well phenotyped cardiomyopathies (CMP)~     including in depth clinical and molecular phenotyping to enable earlier and specific~     treatment. The project will serve as:~        1. resource for diagnostic and therapeutic trials~        2. common biomaterial bank~        3. resource for detailed molecular analyses on patients' biomaterials and patient specific~          symptoms and examination results~   "
3033|NCT03527173|"~     The purpose of this study is to evaluate the efficacy, safety and immunogenicity of the~     GSK3536852A vaccine, which was designed to protect against shigellosis caused by Shigella~     sonnei (S. sonnei) and is using the new Generalized Modules for Membrane Antigens (GMMA)~     platform technology developed by GlaxoSmithKline (GSK) Vaccines Institute for Global Health~     (GVGH).~      The study vaccine could be the stepping stone for the development of a multivalent broadly~     protective Shigella vaccine for vaccination of impoverished communities where shigellosis is~     endemic. However, a standalone monovalent vaccine against S. sonnei could be used to protect~     travelers against diarrheal shigellosis, as the vast majority of travelers' shigellosis is~     caused by S. sonnei, and even to protect infants in endemic regions where shigellosis is~     primarily caused by S. sonnei.~      The GSK3536852A vaccine has been tested in two Phase I dose escalation studies in Europe to~     assess its safety and immunogenicity via three routes of administration: intramuscular (IM),~     intranasal (IN) and intradermal (ID). The results from the first study (dose escalation with~     IM vaccination) have shown that the vaccine has an acceptable safety profile and is~     well-tolerated up to a dose of 100 micrograms (µg). The results from the second study (dose~     escalation with ID, IN and IM vaccination) showed that GSK3536852A vaccine is well-tolerated~     also when administered by the ID and IN routes of vaccination. However, immunogenicity data~     have shown that GSK3536852A vaccine administered by the ID and IN routes is not as~     immunogenic as GSK3536852A vaccine administered by the IM route. Therefore, it has been~     decided to proceed with the clinical development program of this vaccine only using the IM~     vaccination route. In terms of dosage, the regimen tested in Phase I studies (three doses~     given one month apart) did not show any significant benefit from the third dose in terms of~     immunogenicity, therefore a two dose schedule was selected for next studies.~      A Phase IIa study, conducted in endemic regions of Africa (i.e., Kenya), has just been~     completed and confirmed the acceptable safety profile and immunogenicity of GSK3536852A~     vaccine.~      Performing this vaccine-human challenge study may give the opportunity to establish evidence~     of clinical protection induced by the candidate S. sonnei vaccine (GSK3536852A vaccine) at an~     early development stage.~   "
6079|NCT03487276|"~     The purpose of this study is to determine whether IFX-1 is safe and effective in the~     treatment of moderate to severe hidradenitis suppurativa.~   "
3021|NCT03527329|"~     Hypothermia is a frequent perioperative complication. Its appearance can have deleterious~     effects such as myocardial ischemia or perioperative bleeding. When the negative effects of~     anesthesia on temperature are aggravated by other factors, such as glycine infusion in~     transurethral resection, temperature can decrease even more. Once the temperature has~     decreased, its treatment is difficult. Preoperative warming prevents hypothermia, lowering~     the temperature gradient between core and peripheral compartments and reducing thermal~     redistribution. The most recent clinical practice guidelines advocate for active prewarming~     before induction of general anaesthesia since it is very effective in preventing~     perioperative hypothermia. However, the ideal warming time prior to the induction of~     anesthesia has long been investigated. This study aims to evaluate if different time periods~     of preoperative forced-air warming reduces the incidence of hypothermia at the end of surgery~     in patients submitted to transurethral resection. This is an observational prospective study~     comparing routine practice of pre-warming in consecutive surgical patients scheduled to~     undergo elective transurethral resection between March 2014 and April 2018. Three-hundred~     patients are included in this study and prewarming will be applied following routine clinical~     practice. The prewarming time will depend on the time the patient has to wait before entering~     in the operating theatre. Measurement of temperature will be performed using a tympanic~     thermometer. Patients will be followed throughout their hospital admission. Data will be~     recorded using a validated instrument and will be analysed using the statistics program R~     Core Team.~   "
3022|NCT03527316|"~     Serotonin and oxytocin play a role in fear conditioning and fear extinction learning,~     psychological processes that are critically involved in psychiatric disorders such as~     posttraumatic stress disorder (PTSD). Specifically, administration of oxytocin has been shown~     to facilitate fear extinction in humans. Similarly, substances that release serotonin and~     oxytocin such as MDMA have been shown to enhance the extinction of fear memory in animals.~     However, there are no data on the effects of MDMA on fear extinction in humans. Therefore,~     the primary aim of this study is to investigate the role of acute serotonin release in the~     effects of fear extinction. MDMA will be used as pharmacological tool to induce serotonin~     release in this study.~   "
3023|NCT03527303|"~     The aim of this study is to test the effects of a digital meditation intervention in a sample~     UCSF employees who report mild to moderate stress. We will randomize UCSF employees to either~     8-weeks of a digital meditation intervention (using the commercially available application~     Headspace) or a waitlist control condition.~   "
3024|NCT03527290|"~     This pilot study aims to recruit 30 adults with abdominal obesity, without major chronic~     disease, and test whether clinical dietary advice that is solely focused on the timing of~     eating (time restricted eating), has an effect on cardiometabolic health compared to standard~     dietary advice for cardiometabolic health, which is focused on content. The goal of this~     pilot study is to develop and hone dietary counseling approaches for time restricted eating~     for RD's in a clinical practice paradigm, and collect data on testing this intervention~     compared to standard dietary counseling approaches for cardiometabolic health.~   "
3025|NCT03527277|"~     The objectives of this proposal are to address the gaps in knowledge regarding the metabolic~     effects of consuming orange juice, the most frequently consumed fruit juice in this country,~     compared to sugar-sweetened beverage.~   "
3026|NCT03527264|"~     This research study is a Phase II clinical trial. Phase II clinical trials test the safety~     and effectiveness of the investigational drug in combination with radiation to learn whether~     the drug(s) works in treating a specific disease. In this study, researchers are studying~     three treatment arms, each using standard chemotherapy, with the drug cisplatin and radiation~     and the drug Nivolumab. Each treatment Arm will test the addition of Nivolumab at a different~     time point~   "
3027|NCT03527251|"~     Immunotherapy has made rapid progress in melanoma, Hodgkin's lymphoma, non-small cell lung~     cancer, and bladder cancer, etc. Preclinical data suggested that the use of anti-PD-1~     antibody in combination with CTLA-4 receptor blockers may increase antitumor activity. The~     CheckMate-012 study showed that nivolumab and ipilimumab combination therapy achieved an~     overall response rate of 43% in unselected patients with non-small cell lung cancer, compared~     with 23% in the nivolumab monotherapy group; and in the PD-L1 positive subgroup, nivolumab in~     combination with ipilimumab showed a response rate of 57%, while nivolumab alone was 28%.~     This showed that the combination therapy of nivolumab and ipilimumab can increase the~     efficacy, but the adverse events of grade 3 or above of combination therapy reach 37%. The~     toxic side effects limit the widespread use of nivolumab in combination with ipilimumab~     therapy.~      However, since the action of ipilimumab is limited to the initiation of the immune response~     (antigen presentation and immune cell activation), and its long half-time of 15.4 days,~     ipilimumab can used as an induction therapy, following by the PD1 monoclonal antibody. This~     phase I study is aimed to evaluated the safety and efficacy of CTLA-4 antibody followed by~     PD-1 antibody in patients with recurrent or metastatic non-small cell lung cancer.~   "
3028|NCT03527238|"~     Clinical trial applying Phenotypic Precision Medicine (PPM) to tacrolimus dosing in liver~     and/or kidney transplant recipients to show improvement in maintaining drug trough levels~     within the target range.~   "
3029|NCT03527225|"~     The primary hypothesis of the study is that listening to music will reduce anxiety in female~     cancer patients during the first radiotherapy treatment session.~   "
3030|NCT03527212|"~     A double-masked, randomized, multi-center, placebo-controlled, parallel-group study in adult~     patients with Dry Eye Disease (DED). Patients will be randomly assigned to receive either~     SJP-0035 0.001% or placebo~   "
3031|NCT03527199|"~     Evaluation of detection rate of 18F-Fluciclovine compared to current standard of care imaging~     techniques within 30 days of the standard of care imaging study and a 6 month phone follow-up~   "
3032|NCT03527186|"~     This is an open-label, one sequence study to evaluate the steady-state comparative~     bioavailability of 100 mg Risperidone ISM® injectable every 4 weeks compared to once daily 4~     mg oral risperidone in subjects with schizophrenia stabilized on oral risperidone treatment.~   "
3049|NCT03526965|"~     Neck Pain caused by Cervical spondylosis (CS) is one of the most common health complaints.~     Despite its frequency as clinical problem worldwide, there are few evidence-based studies~     that document efficacy of therapies for neck pain. The aim of this study was to evaluate the~     effects of Yoga chikitsa (Yoga therapy) on pain and quality of life (QOL) in CS patients~     compared to usual care.~   "
3034|NCT03527160|"~     Nephrotoxic medication (NTMx) exposure is one of the most commonly cited causes of acute~     kidney injury (AKI) in hospitalized children, and is the primary cause of AKI in 16% of~     cases. Through initial work at Cincinnati Children's Medical Center, NTMx exposure was found~     to be potentially modifiable and the associated AKI is an avoidable adverse safety event.~     Currently, only serum Creatinine monitoring is available to monitor for NTMx-associated AKI.~     The hypotheses of this NINJA NGAL study are that (1) urine NGAL is highly sensitive to detect~     NTMx-associated AKI, and (2) Bedside test of urine from high risk NTMx-exposed patients are~     adequate and reliable compared to urine NGAL measured from the clinical platform.~   "
3035|NCT03527147|"~     This is a Phase 1 platform protocol designed to evaluate various targeted agents for the~     treatment of relapsed/refractory aggressive Non-Hodgkin's Lymphoma (NHL).~   "
3036|NCT03527134|"~     Post-operative cognitive dysfunction (POCD) is a fairly well-documented clinical phenomenon.~     Investigators will determine whether amantadine can reduce the occurrence of POCD in elderly~     patients with major abdominal surgery.~   "
3037|NCT03527121|"~     This study evaluates the effectiveness of pain guided early weight bearing as a means to~     enhance the outcome of acute lateral ankle sprain. Half of the participants will receive~     advice and instructions in pain guided early weight bearing plus a written home-based~     exercise program, while the other half will receive advice and instructions following~     standard operating procedures at site.~   "
3038|NCT03527108|"~     Cohort A in this study will enroll Immuno-oncology (IO) naïve patients who have progressed on~     previous chemotherapy or targeted therapies. The subjects will be randomized 2:1(combination:~     nivolumab monotherapy), with primary endpoint of 6-months PFS.~      Cohort B will enroll patients with prior IO therapy (alone or in combination with~     chemotherapy or in combination with other IO agents), into a non-randomized combination~     trial, with primary endpoint of disease control rate.~   "
3039|NCT03527095|"~     This is a randomised, cross-over study comprised of 6 periods in healthy subjects.Subjects~     will receive Regimens A, B and C in a randomised crossover manner in the fed state, followed~     by Regimens D, E and F in a randomised crossover manner, in the fasted or fed state, as~     applicable.~   "
3040|NCT03527082|"~     This is a questionnaire study that is being performed to ascertain the knowledge and~     attitudes of women towards use of mesh in gynaecological surgery. Women over the age of 18,~     able to read and comprehend the information leaflet, sign and give informed consent will be~     eligible to participate. Women who are not fluent in English will be able to participate if a~     translator can convey the information. The trial will be conducted at Epsom and St Helier~     Hospitals, in the United Kingdom. The investigators aim to recruit 150 women to this study.~     No power calculation has been performed as this is an exploratory study.~      However, previous studies have included 64 and 77 women respectively.~   "
3041|NCT03527069|"~     The purpose of this study is to evaluate the efficacy of Cipros 10 association in the~     treatment of Isolated Hypertriglyceridemia and Dyslipidemia Treatment~   "
3042|NCT03527056|"~     Carbapenem-Resistant Enterobacteriaceae (CRE) are bacteria that have become resistant to~     carbapenems by producing enzymes that break down carbapenems. The prevalence of CRE continues~     to rise globally but the treatment options are extremely limited. In case series, isolation~     of CRE from any site, whether there is clinical infection or not, has been associated with~     all-cause hospital mortality ranging from 29% to 52%. There are no known methods for reliably~     decolonizing gastrointestinal (GI) CRE. In rare case reports, fecal microbiota transplant~     (FMT) has successfully eradicated gastrointestinal colonization of CRE, but there has been no~     larger study further investigating this. FMT via oral capsules is the least invasive method~     and has demonstrated efficacy and short-term safety in treating patients with recurrent~     Clostridium difficile infections. Therefore, the investigators propose this pilot study to~     determine the effectiveness of oral capsule fecal transplantation in the decolonization of~     gastrointestinal CRE.~   "
3043|NCT03527043|"~     Double-blind placebo-controlled randomized trial of daily escitalopram for 6 weeks in healthy~     men with normal semen analyses and no psychiatric history of depression, bipolar, mania or~     suicidal ideation. Hormone profiles, semen analysis, sperm DNA fragmentation, and sexual~     function will be measured at baseline, after 6 weeks of therapy, and 4 weeks after~     discontinuation of therapy (10 weeks into study).~   "
3044|NCT03527030|"~     The main purpose of the research study is to estimate the prevalence of tobacco product use~     and describe the tobacco use patterns in adults in London, United Kingdom.~   "
3045|NCT03527017|"~     The main purpose of the research study is to estimate the prevalence of tobacco product use~     and describe the tobacco use patterns in adults in Germany.~   "
3046|NCT03527004|"~     The main purpose of the research study is to estimate the prevalence of tobacco product use~     and describe the tobacco use patterns in adults in Italy.~   "
3047|NCT03526991|"~     Parkinson Disease (PD) patients experience a variety of motor issues such as walking~     difficulties, loss of balance, and freezing while walking, which impacts their quality of~     life. Some symptoms, like freezing of gait (FOG), do not respond to medications typically~     used to treat PD. Current surgical procedures used to alleviate PD symptoms also do not~     always improve FOG. Since many traditional therapies have failed for the treatment of FOG,~     researchers have proposed the use of newer treatments. Recent research in animal models and~     clinical human data using SCS has produced promising results, specifically showing~     improvement in FOG with the use of SCS in patients with PD.~      The purpose of this study is to evaluate the effectiveness of spinal cord stimulation (SCS)~     for the management of freezing of gait (FOG) that does not respond to conventional treatments~     in subjects with Parkinson's disease (PD). The investigators hypothesize that SCS~     significantly decreases FOG episodes in patients with PD.~      Aim 1: To assess the effectiveness of thoracic SCS for FOG in PD patients.~      Aim 2: To evaluate the effects of SCS in locomotion, appendicular motor manifestations, and~     frequency of adverse events in PD patients.~   "
3048|NCT03526978|"~     The purpose of this phase III study is to evaluate the immunogenicity and safety of Sabin~     Inactivated Poliovirus Vaccine (Vero cell) in 2-month-old infants.~   "
3109|NCT03526185|"~     To determine the feasibility and safety of administering a regimen of TIL/IL-2, using a cell~     product manufactured in the Yale Advanced Cell Therapy Laboratories, in subjects with~     metastatic melanoma who are not responding or have progressed after receiving prior therapy~     with a PD-1/PD-L1 antagonist used alone or in combination with anti-CTLA-4.~   "
3050|NCT03526952|"~     This study investigates the feasibility and efficacy of an Internet-delivered intervention~     for the sexual and intimate re-adjustment of couples in which one partner is living with a~     permanent ostomy (e.g., colostomy, ileostomy) following treatment for colorectal cancer. The~     two session intervention will be delivered via online videoconferencing and will focus on~     facilitating couples' communication around their sexual and intimate relationship. Exercises~     from sex therapy will be used to scaffold conversations about motivations for having sex,~     intimacy and sensual pleasure, and relational strengths for coping. The intervention aims to~     enhance couples' ability to cope with the changes in their sexual and intimate relationship.~     A group of couples receiving written educational material only will be used as a comparison~     group to measure change in sexual and intimate adjustment over time .~   "
3051|NCT03526939|"~     The overarching purpose of the proposed research is to demonstrate that high coverage~     implementation of combined prevention and care using an innovative approach will end the HIV~     epidemic among PWID in Haiphong, Viet Nam.~   "
3052|NCT03526926|"~     The purpose of this observational study is to provide data on the incidence and severity of~     infusion-related reactions during and immediately following each infusion of VYXEOS during~     the first induction.~   "
3053|NCT03526913|"~     Chronic venous ulcers are considered a problem with a big morbidity impact on both the health~     facilities and patients, skin-grafting have shown not so perfect outcomes with such ulcers.~     In this study, the investigators compare combining autologous platelet rich plasma treatments~     with partial skin grafting in chronic ulcers, the results were compared to using only partial~     skin grafting, and among various types of chronic resistant ulcers.~   "
3054|NCT03526900|"~     This is a multicenter, national, nonrandomized, phase II trial in subjects with nonsquamous~     NSCLC patients that have untreated asymptomatic BM. A pre-screening period using brain MRI~     for patients diagnosed with advanced non-squamous NSCLC EGFR/ALK wild type and ECOG PS 0-1~     will be crucial to identify patients with asyntomatic BM. Forty patients will be recruited.~   "
3055|NCT03526887|"~     Exploratory phase II trial of intravenous (IV) Pembrolizumab MK-3475 as second or further~     line with advanced Non-small cell Lung Cancer (NSCLC) who have failed to a prior treatment~     with anti-PDL1 drug.~      Pembrolizumab 200 mg ,Q3W, IV infusion, Day 1 of each 3 week cycle will be administered until~     disease progression.~   "
3056|NCT03526874|"~     Migraine affects 10-28% of children and adolescents and yet 20-30% of patients are~     ineffectively treated with current oral and nasal options. Peripheral nerve blocks (PNBs),~     injections of local anesthetics over branches of the occipital and/or trigeminal nerves, have~     been associated with possible benefit for pediatric headaches in case series, and may be~     useful for both acute and preventive treatment of migraine for children who fail less~     invasive treatments. In fact, 80% of pediatric headache specialists reported using peripheral~     nerve blocks and carry low risk of serious side effects; however, peripheral nerve blocks~     have never been tested, formally, in a randomized pediatric trial.~      By applying a novel design that utilizes lidocaine cream as a run-in step, investigators~     intend to test the efficacy of the most commonly used peripheral nerve block, the greater~     occipital nerve (GON) block, as an acute treatment for pediatric migraine and determine~     whether lidocaine cream leads to successful blinding of the injection.~      The GON block is expected to prove effective in decreasing the pain of migraine, with~     lidocaine being superior to saline and lidocaine cream maintaining blinding.~   "
3057|NCT03526861|"~     Primary objective:~      To evaluate the efficacy of subcutaneous (SC) administration of tralokinumab compared with~     placebo in treating adolescent subjects (age 12 to <18 years) with moderate-to-severe AD.~      Secondary objectives:~      To evaluate the efficacy of tralokinumab on severity and extent of AD, itch, and~     health-related quality of life compared with placebo.~      To investigate the safety, immunogenicity, and tolerability of SC administration of~     tralokinumab compared with placebo when used to treat adolescent subjects (age 12 to <18~     years) with moderate-to-severe AD.~   "
3058|NCT03526848|"~     The proposed study is a phase 1, open label, randomized study to evaluate the safety and~     antiretroviral activity of seven infusions of 3BNC117 and 10-1074, administered intravenously~     at 30 mg/kg dose level, in human immunodeficiency virus (HIV)-infected individuals on~     combination antiretroviral therapy (ART) and during an analytical interruption of ART.~   "
3059|NCT03526835|"~     This is a Phase I, open-label, multi-center, multi-national, dose escalation, single agent~     study to determine the recommended Phase II dose (RP2D) of MCLA-158 in metastatic colorectal~     cancer (mCRC). The study will assess the safety, tolerability, PK, PD, immunogenicity, and~     anti-tumor activity of MCLA-158 in mCRC and other advanced solid tumors.~   "
3060|NCT03526822|"~     Glioblastoma is the most frequent and aggressive primary brain tumor in adults. A team~     recently showed that baseline plasma levels of matrix metalloproteinase-2 (MMP2) and matrix~     metalloproteinase-9 (MMP9) were correlated to bevacizumab activity in patients with recurrent~     glioblastoma. To date, the biological rationale of this results remains unknown but MMP2~     could be involved in classical angiogenesis while MMP9 could promote vasculogenesis.~      The objectives are to correlate the plasma levels of MMP2 and MMP9 to their Ribonucleic acid~     (RNA) and protein tissue expression, activity and to patient neuro-imaging features. To~     analyze the changes of MMP2 and MMP9 plasma levels during peri-operative period and after~     radio-chemotherapy.~      Methods: Plasmatic levels of MMP2, MMP9, vascular endothelial growth factor-A (VEGFA),~     vascular endothelial growth factor-R2 (VEGFR2), stromal cell-derived factor 1 (SDF1) and~     chemokine receptor-4 (CXCR4) will be analyzed by enzyme-linked immunosorbent assay (ELISA) in~     pre-, post-operative period, before radiotherapy, before adjuvant temozolomide and at relapse~     in newly diagnosed glioblastoma. RNA expression of these factors will be analyzed by reverse~     transcription-Polymerase chain reaction (RT-qPCR) on frozen tumor samples, whereas protein~     expression will be analyzed by ELISA and immunohistochemistry. Enzymatic activity of MMP2 and~     MMP9 will be analyzed by zymography. Tumor volume, infiltration and perfusion degrees will be~     analyzed on Magnetic Resonance Imaging (MRI) performed before and after surgery and before~     adjuvant temozolomide. Neuro-imaging characteristics will be correlated to plasma and tissue~     expressions of these factors.~      The expected results are to better define the expression profile of MMP2, MMP9 and the change~     in their plasma level during treatment, a prerequisite for their clinical use.~   "
3061|NCT03526809|"~     Patients with known ovarian cancer will be imaged up to four times with FDG-PET, C13 MRI and~     other novel MRI techniques during their treatment course including: before the start of any~     treatment (with optional repeat scanning), after the first dose of chemotherapy (optional),~     after the third dose of chemotherapy (optional) and after surgery (optional). Imaging~     findings will be compared to biological properties of cancer tissue samples.~   "
3062|NCT03526796|"~     The aim of current study is to evaluate the effect of hyperbaric oxygen therapy for the~     treatment of chronic antibiotic-refractory pouchitis.~   "
28184|NCT03198078|"~     To determine the safety & efficacy of brexpiprazole monotherapy in the treatment of~     adolescents with schizophrenia.~   "
3063|NCT03526783|"~     Sleeve Gastrectomy is the most performed bariatric procedure worldwide. But a growing number~     of data documents that some patients have to be surgical revised due to weight regain or~     gastro-esophageal reflux disease.~      This study elaborates weather Roux-en-Y gastric bypass (RYGB) or Mini/One anastomosis gastric~     bypass (MGB/OAGB) is a better second step procedure after failed sleeve gastrectomy.~   "
3064|NCT03526770|"~     The diurnal variation in the flow of saliva and hence the composition of saliva is an~     established fact. Consumption of acidic and sweetened food and beverage is known to reduce~     the salivary pH and some of them reduce it to critical pH levels and result in structural~     damage to the hard tissues of the tooth.~      The purpose of this study is to ascertain the effect of the select commercially available~     test carbonated drink containing sugar on the salivary pH and assess the buffering capacity~     of the saliva with or without various intervention measures following the exposure to the~     test carbonated drink at different time intervals.~   "
3065|NCT03526757|"~     Importance: Aging is characterized by numerous molecular, physiological, functional, motor~     and psychological changes, such as loss of postural balance and reduced muscle mass/strength.~     Such modifications often lead to reduced physical-functional capacity in the elderly and~     increased risk of falls. Currently, physical exercise is widely used to improve physical~     performance and reduce, at least in part, postural instabilities and the risk of falls. In~     this context, the Pilates method may be a good strategy to improve body balance, muscle~     strength and, potentially, the perception of quality of life in this population, depending~     how the exercises are performed. This study seeks to assess whether practicing Pilates~     exercises in orthostatic position results in differential effects on walking mobility and~     postural balance in healthy elderly women when compared to the standard sequence in the~     Pilates method, which involves less time performing exercise in the orthostatic position. The~     study hypothesis is that a higher relative volume of Pilates exercises performed in the~     orthostatic position can promote greater benefits in terms of walking mobility and postural~     balance compared to the standard Pilates protocol in the elderly.~   "
3066|NCT03526744|"~     The potential use of marine protein hydrolysates (MPH) as a supplement with similar or better~     health benefits than a regular white fish meal, can be regarded both cost-effective,~     environmental friendly and sustainable. The aim of this study is to investigate the potential~     effect of increasing/different doses of MPH supplement on urinary nitrogen retention in~     healthy elderly, to provide a basis for the optimalization of the daily dose for further use~     of MPH in clinical study protocols in elderly patients with sarcopenia, other inflammatory~     conditions or abnormal glucose metabolism.~   "
3067|NCT03526731|"~     A significant component of pain experienced after abdominal surgery is related to incision of~     the abdominal wall and adequate analgesia can be a challenge.~      The ultrasound-guided (USG) quadratus lumborum block QLB was first described by Rafael Blanco~     in a presentation at ESRA 2007 at the XXVI Annual ESRA Congress in Valencia, Spain. Blanco~     described a potential space posterior to the abdominal wall muscles and lateral to the~     quadratus lumborum muscle where Local anesthetics can be injected. This technique provide~     analgesia after abdominal surgery due to spread of LA from its lumbar deposition cranially~     into the thoracic paravertebral space where lateral and anterior cutaneous branches from Th7~     to L1 can be blocked . This was proved by Carney et al. who found traces of contrast agent in~     the TPVS following application of this block A novel USG QL block is the transmuscular~     approach which relies on clearly identifiable sonographic bony landmarks, Where the needle is~     advanced through the QL muscle, penetrating the ventral proper fascia of the QL muscle and LA~     is finally injected between the QL and Psoas major (PM) muscle. The transmuscular QL block~     does not result in redundant antero-lateral spread of the injectate. This may indicate that~     lower volumes of LA potentially can be used and yet provide extensive thoracolumbar~     anesthesia.~      This study was designed to compare the duration of analgesia provided by the original QLB and~     transmuscular QLB in patients undergoing surgical repair of unilateral inguinal hernia.~   "
3068|NCT03526718|"~     Despite decades of a solid leprosy control program, including active case finding and~     follow-up on therapeutic outcome, the Comoros islands of Anjouan and Moheli continue to be~     hyperendemic for leprosy, with leprosy case notifications far exceeding those for~     tuberculosis, while the third island, Grande Comore, presents few cases. The high proportion~     (31% in 2015) of disease in children indicates that recent transmission is a major driver of~     the persistent endemicity, and that present control measures are not sufficient. The low~     proportion (2.6% average in last 10 years) of grade II disabilities in newly diagnosed cases~     indicates that case detection is early.~      The main objective of the present proposal is to identify which persons would most benefit~     from prophylactic treatment. The secondary objective is to unravel human, bacterial and~     environmental risk factors for transmission of and progression to leprosy disease, with the~     ultimate goal to reduce the leprosy incidence.. The program has remaining expertise to~     re-establish laboratory confirmation of leprosy patients, allowing to optimize and validate~     molecular genotyping techniques to complement conventional epidemiological investigations in~     a 3-year prospective cohort of leprosy patients and their close contacts, aiming to identify~     transmission links. A third objective is to document diagnostic delays in more detail~      As the leprosy control programme has initiated a pilot study on rifampicin prophylaxis in~     four villages on Anjouan in 2015, a prospective cohort study will permit measuring the~     leprosy incidence in close contacts as well as those in neighboring houses, who did or did~     not receive rifampicin prophylaxis.~      The expected outcome of this project will be to identify risk factors for leprosy~     transmission. Specifically, we expect to identify those contacts at highest risk of~     developing leprosy disease, who would most benefit from rifampicin prophylaxis or other~     preventive measures.~   "
3069|NCT03526705|"~     Psoriasis is an immune-mediated skin disease that affects 1-2 % of the population. Several~     cytokines have been found to be involved in the complex pathogenesis of this disease. Il- 36~     is one of the cytokines sharing in psoriasis pathogenesis, as its levels are elevated in~     psoriatic plaques. NB-UVB is one of the important treatment modalities for psoriasis.~      The aim of this study is to detect the effect of NB-UVB on the lesional levels of IL-36 in~     psoriasis.~   "
3070|NCT03526692|"~     This is a non-pharmacological study evaluating the effects of SMR/delta ratio and beta1/theta~     ratio neurofeedback trainings on cognitive performance and electrical brain activity in~     elderly with mild cognitive impairment.~   "
3071|NCT03526679|"~     This study is designed to test the safety and efficacy of the combination of lenvatinib, a~     drug that can inhibit the growth of supplying vessels around the tumors, and eribulin, a~     chemotherapy drug that targets the cancer cell during mitosis, in inoperable or metastatic~     adipocytic sarcoma and leiomyosarcoma.~   "
3072|NCT03526666|"~     This study is a non-interventional, specimen collection translational study to evaluate~     vitamin C levels in the peripheral blood of Acute Myeloid Leukemia (AML), Myelodysplastic~     Syndrome (MDS), or Chronic Myelomonocytic Leukemia (CMML) patients.~   "
3073|NCT03526653|"~     Elderly in residential care spend 97% of their time sedentary. Moreover, exercise therapy~     often takes place in a poorly stimulating environment which is less motivational for the~     elderly to undertake regularly. Exercise is however necessary to preserve their physical~     capabilities and to limit their care dependence.~      The aim of this study is to investigate the most motivating and stimulating exercise modality~     for prefrail and frail elderly in nursing homes with which they can reach sufficient training~     volume.~      To study this, elderly will exercise in 3 different ways on an ergometer or motomed~     (according to their physical capabilities): 1) in an environment without other visual stimuli~     2) in front of a television with National Geographic images 3) with the interactive software~     program MemoRide with which participants can exercise in real life on a virtual manner.~      MemoRide (Activ84Health) uses Google Street View images. The starting point is a connection~     between an exercise bike and a tablet with a pedalling sensor. This way, pedal frequency is~     sent to the tablet and as a result, images continue when pedalling.~      The forth modality is the control modality, in which participants are instructed to rest~     (supine) during 30 minutes.~      Based on objective training parameters and metabolic parameters e.g. glucose, insulin,~     brain-derived neurotrophic factor (BDNF) and lactate, (via a blood sample with a venous~     catheter) the training modality which offers the best training results will be studied.~     Secondly, also subject experiences (motivation and emotions) will be evaluated by using~     questionnaires and observation scales.~   "
3074|NCT03526640|"~     Protocol Title:~      Computed Tomography (CT) Guided Lung Biopsy with BioSentry Plug, Evaluation of Safety and~     Efficacy.~   "
3075|NCT03526627|"~     The purpose of this study is to explore the trajectory of advanced management care in~     patients with heart failure over a period of 9 months, then comparing the medical treatment~     accepted by patients after 2 years later and compliance with the preferences of patients and~     their families.~   "
3076|NCT03526614|"~     Patients treated with percutaneous coronary intervention (PCI) require dual antiplatelet~     therapy (DAPT). Preliminary assessment of the PRECISE-DAPT score is mandatory in order to~     assess the risk of bleeding while on DAPT. The score takes into consideration age, creatinine~     clearance, haemoglobin, white-blood-cell count and previous spontaneous bleeding. One should~     consider, however, that some of the variables included in the PRECISE-DAPT score might change~     with time. As a consequence, the PRECISE-DAPT score should not be considered a static score~     as it might vary after the initial computation. It remains unknown, however, if the delta~     PRECISE-SCORE, reflecting the change in score between baseline and follow-up, might predict~     more reliably the long-term bleeding risk of PCI patients.~   "
3077|NCT03526601|"~     Screening Of adult urBan pOpulation To diAgnose Heart Failure (SOBOTA-HF) is a~     cross-sectional prevalence study in a representative sample of Murska Sobota residents aged~     55 years or more. Individuals will be invited to participate in a screening with NT-proBNP.~     All subjects with NT-proBNP ≥ 125 pg/mL will be invited for a diagnostic visit that will~     include history and physical examination, electrocardiogram, echocardiography, ankle brachial~     index, pulmonary function tests, body composition measurement, physical performance tests and~     questionnaires. To validate the screening procedure, a control group (NT-proBNP < 125 pg/mL)~     will undergo same diagnostic evaluation. An external center will validate echodardiography~     exams and the HF diagnosis will be adjudicated within an independent HF expert panel. Overall~     and age specific HF prevalence will be calculated in individuals ≥ 55 years and extrapolated~     to the whole population.~   "
3078|NCT03526588|"~     The purpose of this study is to investigate the use of autologous umbilical cord blood (UCB)~     mononuclear cells to mitigate hypoxic neurologic injury among infants with high-risk~     congenital diaphragmatic hernia (CDH).~   "
3079|NCT03526575|"~     In the study titled Operational Ground Testing Protocol to Optimize Astronaut Sleep~     Medication Efficacy and Individual Effects (Phase 11), two randomized , blinded ,~     placebo-controlled , cross-over trials will be conducted. The hypnotic medication and the~     placebo will be indistinguishable by subjects. Experiment 1 will involve N=14 subjects~     randomized to placebo , 10 mg Zolpidem (Ambien) and 10 mg Zaleplon (Sonata) in~     counterbalanced order and will be awakened 90 min. post-placebo administration (half at 60~     min and half at 90 min). The latter will be done to maintain some degree of blinding relative~     to the participants knowledge of conditions and the staff working on the protocol. Zolpidem~     is the most commonly , and Zaleplon is the second most commonly , used sleep aid medication~     used in spaceflight. Females and those subjects who have had a previous adverse experience~     with 10 mg zolpidem will be placed into Experiment 2, which will involve N=20 subjects~     randomized to placebo , 5 mg zolpidem and 10 mg zaleplon. Data acquisition for both~     experiments will occur in the Astronaut Quarantine Facility (AQF) at Johnson Space Center~     (JSC). Experimental methods and cognitive outcomes will be the same as those used in the~     pilot investigation titled Develop and Implement Operational Ground Testing Protocols to~     Individualize Astronaut Sleep Medication Efficacy and Individual Effects (Phase I). Combined~     , Experiment 1 and 2 will provide data on zaleplon 10 mg compared to placebo on a total of 34~     subjects consisting of astronauts and other subjects considered analogous to the astronaut~     population (e.g., Flight Controllers, Flight Directors , Flight Surgeons, medical residents~     and medical students on National Aeronautics and Space Administration (NASA) rotation, and~     NASA/contractor employed University of Texas Medical Branch physician's) , which will provide~     the larger sample needed to identify those subjects who have cognitive performance deficits~     on abrupt awakening to the less sedating 10 mg zaleplon.~   "
3080|NCT03526562|"~     Recent drug improvement (e.g. abiraterone or enzalutamide) for castration resistant prostate~     cancer (CRPC) patients has improved survival. As treatment strategies improve and patients~     live longer, patients must cope with their treatment-induced adverse effects. Improving~     levels of physical activity (PA) and less amounts of sitting time (e.g. sedentary behavior,~     SB) could have a positive impact on patient's health, non-cancer mortality, and quality of~     life and potentially improve survival.~      The role of PA has not yet been examined in CRPC patients, which is a clear unmet need. No~     specific PA guidelines exist for CRPC patients, but specific guidelines are warranted because~     of advanced disease stage, reduced performance score and comorbidity. It is to be expected~     that the PA level of CRPC patients is lower compared to non-CRPC patients receiving androgen~     deprivation therapy (ADT).~      This study aims to determine the optimal starting physical therapy prescription in CRPC~     patients receiving second line hormone treatment.~   "
3081|NCT03526549|"~     A Phase 3b, Open-Label Extension Study to evaluate safety and how long response of EN3835~     lasts in the treatment of Cellulite.~   "
3110|NCT03526172|"~     High tibial osteotomy (HTO is often indicated in physically active patients. The insertion of~     a bone graft during surgery has been shown to have good clinical and biomechanical outcomes,~     however objective data regarding post-surgery physical activity (PA) levels in patients who~     have undergone HTO with and without bone grafts does not exist in the literature.~      Using accelerometers and questionnaires, this study will be the first to investigate this in~     an objective way.~   "
37848|NCT03071224|"~     The overall goal of this protocol is to evaluate [18F]MK-6240 (also known as [18F]MNI-946) a~     tau targeted radiopharmaceutical.~   "
3082|NCT03526536|"~     This study is for people with diabetes who have either healthy kidneys or who have end stage~     renal disease (ESRD) and are on hemodialysis that are having surgery. This research will help~     increase our knowledge about how having diseased kidneys and being on hemodialysis changes~     how the body responds to insulin. In the time period directly before, during, and after~     surgery, maintenance of blood sugar within normal physiological range is essential. When~     patients come for surgery and have an elevated blood sugar, it is up to each individual~     physician to decide on the right amount of insulin to treat them. Currently, there are many~     different protocols across the country to treat elevated blood sugar; however, there is no~     one specific protocol to treat elevated blood sugar at SUNY Downstate Medical Center at this~     time. In this study, the investigators will evaluate the change in blood sugar following~     insulin administration to determine whether there is a significantly different response~     between ESRD and non-ESRD patients. The results of the study will help develop safer practice~     guidelines to patients with ESRD with an elevated blood sugar while they are having surgery.~   "
3083|NCT03526523|"~     Depression is the leading cause of disability worldwide and a risk factor for other diseases.~     While women are at elevated risk for depression in general, the menopause transition is a~     particularly vulnerable time for many women, with the risk for depression increasing 2-4~     fold. The objective of this research study is to determine whether mindfulness-based stress~     reduction (MBSR), an 8-week structured intervention involving meditation and yoga, has any~     beneficial mood effects for women undergoing this vulnerable time.~   "
3084|NCT03526510|"~     Randomized trial comparing 2 external beam radiotherapy fractionation schemes in patients~     with localized high risk prostate cancer. Primary endpoint is acute toxicity.~   "
3085|NCT03526497|"~     In patients admitted to a coronary care unit, what is the correlation coefficient and limits~     of agreement for paired measurements of peripheral venous pressure and central venous~     pressure at multiple time points during the patient's hospitalization?~   "
3086|NCT03526484|"~     The primary focus of this randomized clinical trial is to assess the usefulness of urinalysis~     prior to in-office urology procedures.~   "
3087|NCT03526471|"~     Atrial fibrillation is associated with increased risk of stroke mostly because of clot~     formation in the left atrial appendage, a small alcove in the left atrium heart chamber.~     Plugging this appendage with an implantable plug type device, which is placed via a catheter~     painlessly in the femoral vein, has been proven to be a reliable alternative to the standard~     anti-clotting medication in a number of recent international trials. The Omega device is a~     new design of such a plug, made from biocompatible and compressible nitinol and fabric.~      65 patients will be enrolled in this study in Europe and Asia.~      The primary performance endpoint of the study is LAA closure (defined as complete seal or~     efficient seal with a leak ≤ 5 mm) at the 45-60 day visit documented by transoesophageal~     echocardiogram.~   "
3088|NCT03526458|"~     The primary objective of this study is to compare the time to acceptable stone fragmentation~     during clinical use of the holmium laser when using energy settings 0.2J vs 0.8J. The~     hypothesis is that holmium laser energy settings 0.8J will require less time than lower~     energy settings 0.2J for fragmenting urinary stones. The clinical practice is to treat~     urinary stones until the stone is reduced to fragments ≤ 2 mm in size. This is determined by~     using the laser fiber which is 273 microns to visually estimate the size of the resultant~     fragments as described by Patel et al, J Endo 2014. Investigators will standardize the effect~     of stone size by creating a ratio of stone size to treatment time. In this study, the~     frequency is set at 15Hz. Thus, the study contains two arms: 0.2J&15Hz, and 0.8J&15Hz.~     Patients will be randomized into the two groups by the ratio of 1:1.~   "
3089|NCT03526445|"~     The objective of the study is to investigate how exogenously administered glucagon affects~     hepatic lipid, glucose and protein metabolism as well as appetite, food intake and resting~     energy expenditure.~   "
3090|NCT03526432|"~     This is a single arm, Phase II study using the combination of atezolizumab and bevicacizumab~     in women with advanced, recurrent or persistent endometrial cancer. Safety and futility of~     this drug combination will be assessed to see what effect this treatment has on this patient~     population.~   "
3091|NCT03526419|"~     Investigate the pharmacokinetics of Liposomal Bupivacaine and its excretion in breast milk in~     patients undergoing TAP block after their scheduled C -section delivery~   "
3092|NCT03526406|"~     This acute-on-chronic study will examine the effectiveness of CP9700 for improving cognitive~     performance and mood in healthy young adults. CP9700 is a mix of highly purified grape~     seed-derived polyphenolic extracts from Vitis vinifera produced by Polyphenolics Inc.~     (Madera, CA, USA). The polyphenolic component of the product is comprised entirely of~     catechin and epicatechin, derivatives of catechin and epicatechin (e.g.,epicatechin gallate),~     and proanthocyanidins. We will perform a randomised, double-blind, parallel-groups human~     intervention trial using CP9700 and a well characterised sugar-matched placebo to investigate~     changes in cognitive performance.~   "
3093|NCT03526393|"~     The individual adapted sport modalities concentrate most of the technological development for~     equipment and auxiliary devices, the collective modalities need implements that aid in the~     development of training and the game.~   "
3094|NCT03526380|"~     Prescription opioid overdose represents a public health crisis. A number of efforts have been~     implemented to address opioid prescribing and opioid risk mitigation strategies for~     prescribers, but relatively few efforts have sought to address this problem directly with~     individuals who use opioids. This gap likely fails to fully address the inherent reinforcing~     nature of the medications that make it challenging to reduce use.~      The specific aim of this study is to pilot test a toolkit that pairs an intervention with the~     distribution of naloxone. External facilitation (supervision check-ins) will aid translation~     to delivery by non-research staff. Firstly, data will be collected from participants over~     time as a control group, prior to training site staff. Next, non-research staff will be~     trained on the intervention. Staff at the site will use the online toolkit developed in the~     beginning of this project to deliver the interventions and naloxone to their clients/patients~     as part of usual care. After staff at the site(s) are trained, additional data will be~     collected from participants during the intervention period and after 3-months.~   "
4880|NCT03503032|"~     Evaluation of fenestration benefit in Extra-cardiac total cavo-pulmonary connection (Fontan~     procedure) in single ventricle anomaly, comparing clinical outcomes of patients with low~     preoperative risk profiles in prospective study~   "
3095|NCT03526367|"~     The CIAKI,as the third complication of PCI, was associated with adverse cardiac events after~     procedure. Moreover, because the rate of periprocedure hydration is inadequate in STEMI~     patients before primary PCI, the incidence of CIAKI is higher significantly in these~     patients. The cardiovascular pleiotropic effects of statins in addition to lipid have been~     widely concerned. The previous studies demonstrated usage of statin in periprocedure could~     decrease the risk of CIAKI. Compared with hydration, the usage of statin to prevention CIAKI~     show the advantages in clinical practice, for example，there is no need to consider the~     cardiac function.The optimal strategies for preventting CIAKI in STEMI patients undergoing~     primary PCI needed further studies to explore. What's more, whether a synergistic effect of~     hydration and statin or not is unknown.~   "
3096|NCT03526354|"~     The proposed study is a 3-site, 12-week, novel, feasibility, investigation of patients who~     have co-occurring diagnoses of schizophrenia and current substance use disorder (alcohol,~     cocaine, heroin, or cannabis). Eighty patients will be randomly assigned to switch to~     brexpiprazole (the brexpiprazole group) or remain on the same antipsychotic treatment (the~     control group). The study will be conducted at 3 sites in the US. The investigators expect to~     enroll 80 subjects across 3 sites. UMass Medical School, Worcester MA is the lead site.~     Sub-sites include Massachusetts General Hospital (MGH) and the University of North Carolina~     at Chapel Hill (UNC).~   "
3097|NCT03526341|"~     A post-market clinical follow-up study for ReliaTack™ articulating reloadable fixation device~     with deep purchase tacks~   "
3098|NCT03526328|"~     The hypotheses are: 1) the intestinal stem cell marker, DCLK1, which is increased in both the~     epithelium and stroma in colon cancer is also increased in BE (Barrett's esophagus) with HGD~     (high grade dysplasia) and in EAC (esophageal adenocarcinoma), 2) this expression correlates~     with disease progression towards EAC and 3) eradication of cells expressing stem cell markers~     occurs after therapy of EMR (endoscopic mucosal resection) or RFA (radiofrequency ablation)~     to eradicate BE with HGD and intramucosal adenocarcinoma and esophagectomy for EAC. We will~     test our hypotheses with the following aims: 1) To characterize the cell specific expression~     patterns of intestinal stem cell biomarkers in BE patients and correlate them with serum~     expression and disease progression, 2) To examine prospectively the effects of EMR, RFA or~     esophagectomy on the expression of stem cell biomarkers and the progression to EAC.~   "
3099|NCT03526315|"~     This study is a randomized controlled trial involving 127 children ages between 4 and 5 years~     to investigate the efficacy of Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP) in~     reducing Streptococcus mutans (S. mutans) bacteria, and compare that with fluoride alone, or~     combined use of fluoride and CPP-ACP over a 6 month period using Saliva Check Mutans kits to~     detect Mutans Streptococci (MS). It is expected that all used anti-cariogenic agents will~     have the ability to reduce the S. mutans level in different values.~   "
3100|NCT03526302|"~     Serum Troponin levels pre- and postoperatively will be compared in patients receiving an~     entirely subcutaneous cardioverter-defibrillator.~   "
3101|NCT03526289|"~     The primary aim of the study is to evaluate how GIP receptor activation influence food intake~     and mechanisms regulating food intake in obese individuals with type 2 diabetes that are in~     steady treatment with metformin and a GLP-1 receptor agonist.~   "
3102|NCT03526276|"~     This study is a randomized controlled trial involving 118 children ages between 4 and 5 years~     to assess the remineralization effect of Casein Phosphopeptide-Amorphous Calcium Phosphate~     (CPP-ACP) on white spot lesions in primary teeth using Quantitative Light-induced~     Fluorescence (QLF) system, and compare that with fluoride alone or combined use of fluoride~     and CPP-ACP.~   "
3103|NCT03526263|"~     Rapid metabolic improvements seen with sleeve gastrectomy are likely a result of changes in~     gastric origin. The gastric mucosa is an endocrine organ that regulates satiation pathways~     and is a complex regulator of food intake as well as lipid and glucose metabolism. This study~     aims to assess the efficacy and safety of endoscopic selective gastric mucosal devitalization~     (GMD) for the management of obesity and its related comorbidities.~   "
3104|NCT03526250|"~     This phase II Pediatric MATCH trial studies how well palbociclib works in treating patients~     with Rb positive solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with activating~     alterations (mutations) in cell cycle genes that have spread to other places in the body and~     have come back or do not respond to treatment. Palbociclib may stop the growth of cancer~     cells by blocking some of the enzymes needed for cell growth.~   "
3105|NCT03526237|"~     (Sisters Health And Primary CarE Uniting and Preventing Diabetes; aka SHAPE UP) will consist~     of: 1) Neighborhood DPP Intervention: group DPP sessions and individual coaching; 2)~     Preventive Care Coordination to FQHC: referral, navigation assistance, patient activation,~     linkage to primary care (community initiated referrals) and linkage to DPP program (FQHC~     initiated referrals)~   "
3106|NCT03526224|"~     This study will investigate the effect of teriflunomide in reducing cortical gray matter~     (CGM) atrophy and leptomeningeal (LM) inflammation over 24 months compared to dimethyl~     fumarate (Tecfidera®)~   "
3107|NCT03526211|"~     Intensive care unit acquired muscle weakness (ICUAW), is a common disease which influence~     rehabilitation, extend mechanical ventilation and length of stay in intensive care unit, and~     affect quality of life at hospital discharge.~      To prevent ICUAW, different strategies of early mobilization are recommended. But all cannot~     be applied in all ICU patients. Some of them benefit from heavy therapies like circulatory~     assistance or renal replacement therapy for example, that limit mobilization.~      Cycloergometer is a tool that allows continuous passive mobilization in bedridden and even~     unconscious patients.~      Neuromuscular electrical stimulation (NMES) is an alternative that helps preserve muscle mass~     and limit muscle atrophy.~      Early bedside cycle exercise coupled with NMES is an interesting new approach where~     application of an electrical stimulation along specific motor nerves on each lower limb,~     generates muscles contractions and pedaling on cycloergometer.~      The aim of this study is to evaluate safety and feasibility of this coupled technique called~     Functional Electrical Stimulation (FES) Cycling, in ICU patients.~   "
3108|NCT03526198|"~     This study developed a controlled soil reaction force platform that provided controlled~     mechanical stimuli to quantify the distribution of the center of mass as a function of the~     angular variation of the ankle in the elderly in the upright position.~   "
6273|NCT03484741|"~     The purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells~     (MSCs) transplantation for type 1 Diabetes Mellitus patients.~   "
3111|NCT03526159|"~     Herlitz junctional epidermolysis bullosa (H-JEB), an incurable, fatal, inherited skin~     disease, is caused by loss-of-function mutations in the LAMA3, LAMB3 or LAMC2 genes,~     resulting in loss of laminin 332 and poor epidermal-dermal adherence. Eighty percent of H-JEB~     patients have LAMB3 mutations and about 95% of these are nonsense mutations. The~     investigators recently demonstrated that gentamicin readily induced nonsense mutation~     readthrough and produced full-length laminin beta3 in several nonsense mutations tested.~     Importantly, the gentamicin-induced laminin beta3 restored laminin 332 assembly, secretion,~     and deposition into the dermal-epidermal junction (DEJ). Newly induced laminin 332 reversed~     abnormal H-JEB cellular phenotypes. Herein, the investigators propose the first clinical~     trial of gentamicin (by topical and intravenous administration) in JEB patients with nonsense~     mutations. The milestones will include restored laminin 332 and hemidesmosomes at the DEJ,~     improved wound closure, and the absence of significant gentamicin side effects.~   "
3112|NCT03526146|"~     Nearly 1 in 10 older Americans have dementia, which is a devastating condition that leads to~     a progressive loss of independence and functional status. Mild cognitive impairment (MCI) is~     an intermediate stage between the expected cognitive decline of normal aging and the~     more-serious decline of dementia. The investigators have developed a novel, integrative~     exercise program called Preventing Loss of Independence through Exercise (PLIE) that~     incorporates elements from Eastern and Western exercise modalities and is designed to build~     and maintain the capacity to perform basic functional movements while increasing mindful body~     awareness and enhancing social connection. Pilot study results suggest that PLIE is~     associated with meaningful improvements in physical function, cognitive function and quality~     of life in individuals with dementia, as well as reduced caregiver burden. The goal of the~     current study is to perform a randomized, controlled trial to test the efficacy of PLIE in~     older adults who have MCI but who do not yet have dementia. The investigators will also~     investigate the neural mechanisms underlying PLIE by acquiring brain imaging measures.~   "
3113|NCT03526133|"~     Obstructive sleep apnea (OSA) is common and largely underdiagnosed disease. The standard~     method for the diagnosis of OSA is a complete night polysomnography (PSG). Simple methods for~     OSA diagnosis are necessary. The overnight oximetry with the oxygen desaturation index (ODI)~     has been largely investigated as a diagnostic test for OSA but its accuracy remains~     undefined. The aim of our study is to evaluate if an wireless polygraph (Oxistar) is accurate~     to diagnosis OSA in patients referred to a Sleep Lab.~   "
3114|NCT03526120|"~     The main goal of the study is to confirm that, due to their rich nutritional content in~     protein, polyunsaturated fatty acids, vitamins and minerals of interest (calcium and~     magnesium), the regular consumption of the recommended amount of pistachios by adult women~     will elicit appropriate satiety and compensation in the daily energy intake, and improve diet~     quality, anthropometry and body composition.~   "
3115|NCT03526107|"~     Dietary intervention study in healthy young adult males to evaluate concentration of flavanol~     metabolites in plasma and urine after single acute intakes of methylxanthines.~   "
3116|NCT03526094|"~     Dietary intervention study in healthy adult males to evaluate concentration of flavanol~     metabolites in plasma and urine after single acute intakes of flavanols from different~     fruit-based drinks.~   "
3117|NCT03526081|"~     Probe dietary intervention study in healthy young adult males to evaluate the concentration~     of apigenin derived metabolites in plasma and urine after single acute intakes of different~     apigenin-containing test materials.~   "
3118|NCT03526068|"~     The threat of MRSA and multi-drug resistant pathogens have been growing in recent years. A~     new means of countering the infectious threat is required and one such modality is the use of~     UV light for disinfection. The aim of the study is to proof the efficacy of the 222nm UV~     light in disinfection on patients with sacral sores. This is a first in human~     proof-of-concept study~   "
3119|NCT03526055|"~     The purpose of this study is to evaluate the effect of pulse widths <500 µS and >1000 µS on~     clinical outcomes during a temporary SCS trial.~   "
3120|NCT03526042|"~     Antibodies directed against angiotensin-II receptor (AT1-Ab) are agonist antibodies~     previously studied in human diseases such as preeclampsia, transplantation and scleroderma.~     They act by binding to the AT1 receptor and their effects can be blocked with the use of~     angiotensin receptor blockers (ARB). In this randomized open clinical trial the investigators~     will study the effect of the blockade of AT1-Ab with losartan in carotid intima-media~     thickness progression in patients with lupus nephritis compared to patients treated with~     enalapril.~   "
3121|NCT03526029|"~     The Swiss Conference of Cantonal Health Directors has transferred the planning of highly~     specialized medicine to a specialized body under the direction of the Swiss Academy of~     Sciences. This specialist body has defined the treatment of critically ill as part of highly~     specialized medicine and founded the Swiss Trauma Registry at 12 hospitals in Switzerland.~     The registry is designed to provide a consistent and standardized approach and treatment~     outcomes in the short and long term quality control and as a basis for planning highly~     specialized medicine.~   "
3122|NCT03526016|"~     Sleep apnea is common in acromegaly and both diseases are independently associated with~     hypertension and insulin resistance contributing to increased morbidity and mortality.~     Respiratory polygraphy is a simpler alternative to in-laboratory polysomnography for the~     management of more symptomatic patients with obstructive sleep apnea.~      The aim of this study is to evaluate the prevalence of sleep apnea by respiratory polygraphy,~     and to analyze the effect of transsphenoidal surgery on sleep apnea.~   "
3123|NCT03526003|"~     This study is an observational study measuring the esophageal pressure in anesthetized~     surgical patient undergoing changes in posture and pneumoperitoneum~   "
3124|NCT03525990|"~     PRO-COM Project: Randomized-controlled study evaluating the impact of electronic patient~     reported outcome (ePRO) surveys on patient-physician communication and quality of life in~     patients with advanced breast cancer~   "
3125|NCT03525977|"~     The study is a prospective randomized examining the impact of fascia iliaca block on~     perioperative pain control and post operative ambulation in patients with hip fractures.~   "
3376|NCT03522662|"~     The primary outcome measure of the study is to demonstrate the safety and tolerability of~     GSK1070806 in the Behcet's disease population at 24 weeks, with biochemical and clinical~     efficacy and mechanistic studies to further explore the pathogenesis of Behcet's disease~     important secondary and exploratory outcomes.~   "
3126|NCT03525964|"~     To asses the functional outcome after individualized treatment of acute achilles tendon~     rupture. The treatment is individualizes on the basis of ultrasonographic status of tendon~     overlap and Barfod's Ultrasonographic length measure. Patients are allocacted for operative~     treatment if there the tendon overlap is less than 25 % or the tendon is elongated with 7% or~     more compared to the healthy, contralateral achilles tendon.~      The study includes two control groups of non-operative and operative treatment.~   "
3127|NCT03525951|"~     Early language intervention is critical to improving the academic, social, vocational, and~     health outcomes of at-risk children under five. This at-risk group includes approximately 1.7~     million children with primary developmental language disorder (DLD), 350,000 children with~     autism spectrum disorder (ASD) and millions in adverse early environments (e.g., 5 million~     children living in poverty; Child Trends, 2017; NCCP, 2017; Norbury & Sonuga-Barke, 2017).~     One cost-effective option for addressing this public health issue is caregiver-implemented~     intervention. Caregiver-training programs have proliferated, but have shown vast individual~     differences in outcomes and limited scalability. This project will address this problem by~     examining caregiver and child-level factors that influence the quality of early~     caregiver-child language interaction and early language intervention outcomes. We hypothesize~     that caregiver language abilities and behavioral awareness are associated with interaction~     quality and intervention outcomes.~   "
3128|NCT03525938|"~     the study will evaluate the effect of transversus abdominis plane block (TAP) on chronic~     post-groin surgeries orchalgia (chronic testicular pain)~   "
3129|NCT03525925|"~     This phase I trial studies how well ibrutinib and nivolumab work in treating participants~     with solid tumors that have spread to other places in the body. Ibrutinib may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies,~     such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving~     ibrutinib and nivolumab may work better in treating participants with solid tumors.~   "
3130|NCT03525912|"~     Evaluation of neuropsychiatric and cardiovascular side effects of low dose ketamine analgesic~     infusion for postoperative pain~   "
3131|NCT03525899|"~     To present the clinical characteristics and rational treatment of macular hole (MH) after the~     diabetic vitrectomy (DV) in patients with proliferative diabetic retinopathy (PDR).~   "
3132|NCT03525886|"~     This is a Phase 2, open-label, multiple-dose, dose-escalation study to assess the safety,~     tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of NBI-74788 in approximately~     16 to 20 adult female and male subjects (18 to 50 years of age) with a documented medical~     diagnosis of classic 21-hydroxylase deficiency congenital adrenal hyperplasia (CAH). The~     study will include a sequential-cohort design with 2 NBI-74788 dose cohorts, with each dose~     administered for 14 consecutive days.~   "
3133|NCT03525873|"~     This phase III trial studies how well methylphenidate and physical activity works in reducing~     cancer-related fatigue in participants who are receiving anti-PD1 immunotherapy for melanoma~     that has spread to other places in the body. Central nervous systems stimulants, such as~     methylphenidate, may help to improve cognitive function. Physical activity uses techniques,~     such as aerobic and resistance exercises, which may help to improve quality of life. Giving~     methylphenidate and physical activity may help in reducing cancer-related fatigue in~     participants with metastatic melanoma who receive anti-PD1 immunotherapy.~   "
3134|NCT03525860|"~     A feasibility study on the provision of acupuncture treatment in the hospital to 20 patients~     who have undergone open heart surgery procedures. The acupuncture treatments may begin as~     early as postoperative Day 2.~   "
3135|NCT03525847|"~     A prospective study designed to show the superiority of contrast guided echoendoscopy versus~     conventional echoendoscopy~   "
3136|NCT03525834|"~     The purpose of this study is to assess the safety and efficacy of Afinitor® in Chinese~     patients with renal angiomyolipoma associated with tuberous sclerosis complex (TSC). The~     study will evaluate the safety and anti-tumor activity of Afinitor® given at a dose of 10 mg~     per day.~   "
3137|NCT03525821|"~     The incidence of child fractures is around 180 per 10,000 children under 16 years old in~     industrialized countries. More and more hospitals, such as Nice University Hospital, are~     using vigilant procedural sedation for simple surgical procedures such as fracture reduction,~     allowing ambulatory care. This is why the investigators propose the alternative of intranasal~     ketamine associated with nitrous oxide inhalation in the management of children's pain.~     Indeed, thanks to its short duration of action and short duration of effectiveness, ketamine~     is already used in pediatric anesthesia and resuscitation for many years and is considered~     safe and effective.~      The objective of this work is to evaluate the efficacy of intranasal ketamine associated with~     nitrous oxide inhalation in the reduction of isolated fractures from the extremity of the~     upper limb in children allowing optimal management.~      This work will consist of research involving non-randomized, monocentric prospective~     interventional category 1 for duration of 18 months. Patients over 4 years of age and under~     18 years, with a closed fracture isolated from the distal extremity of the upper limb, with~     stable hemodynamic will be included. In view of active queue of pediatric emergencies Nice~     University Hospital, the investigators can include 60 patients, allowing to have a~     representative sample of the pediatric population.~      The treatment administered will be intranasal ketamine, using a tip MAD® (Mucosal Atomization~     Device) at a dosage of 1 mg/kg in a single administration, under continuous cardiorespiratory~     monitoring for 2 hours. The reduction of the fracture will be done under inhalation of~     nitrous oxide. The primary endpoint will be pain control during and after fracture reduction,~     defined by the FLACC Hetero-Assessment Pain Rating Scale. Others parameters as the evaluation~     of the degree of sedation, evaluation of the child's feeling of pain after the reduction,~     evaluation of the feasibility of the preparation and administration of the drug by the nurse~     will be reported.~   "
3138|NCT03525808|"~     To demonstrate safety and effectiveness of lumen-apposing metal stents for resolution of~     walled off pancreatic necrosis (WONs) in patients with WONs with solid component >30%.~   "
3139|NCT03525795|"~     This is a Phase 1/2, multi-center, open-label study of CPI-1205 + ipilimumab in patients with~     histologically or cytologically confirmed advanced solid tumors. This study is designed to~     determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of CPI-1205 +~     ipilimumab in patients with advanced solid tumors. Patients in Phase 2 will be treated at the~     RP2D of CPI-1205 + ipilimumab.~   "
3140|NCT03525782|"~     The study is to assess the safety and efficacy of the anti-MUC1 CAR T cells and /or PD-1~     knockout engineered T cells for patients with advanced non-small cell lung cancer.~   "
3162|NCT03525483|"~     The aim of the study will be to evaluate the quality of the GFR estimate of the two~     estimation equations (CKD-EPI and Cockcroft's formula) against the measured clearance of~     creatinine, which can be performed routinely in intensive care.~      To determine the proportion of patients with ARC under ECMO VV or VA and determine changes in~     renal vascular resistance index as a function of GFR level in patients with pulsatile cardiac~     output.~   "
3141|NCT03525769|"~     This study is aimed at calculating the incidence of nonalcoholic fatty liver disease (NAFLD),~     non- alcoholic steatohepatitis (NASH) cirrhosis and advanced fibrosis in patients with type 2~     diabetes in China, evaluating the diagnostic efficacy of FibroTouch for hepatic steatosis and~     fibrosis in these patients, analyzing the long-term prognosis and screening potential risk~     factors in patients with both type 2 diabetes and NAFLD.~      This study will use FibroTouch to screen NAFLD, NASH cirrhosis and advanced fibrosis in~     patients with type 2 diabetes, compare the results with liver tissue biopsy to assess the~     clinical value of FibroTouch for the screening of NAFLD in diabetics, then investigate the~     clinical significance of FibroTouch in assessing the long-term prognosis of patients with~     diabetes and NAFLD in a prospective cohort, screen risk factors for diabetes with NAFLD and~     advanced fibrosis.~   "
3142|NCT03525756|"~     Colovesical fistulas are well-recognized but relatively uncommon pathology to both the~     general and colorectal surgeon. It is a complication arising from an underlying primary acute~     to chronic inflammatory process. Although colovesical fistulas are uncommon, they are~     associated with significant morbidity, affect quality of life, and may lead to death, usually~     secondary to urosepsis. Early diagnosis and management is essential.~      The purpose of the study is to determine the objective use of cystographic evaluation on~     postoperative day two to guide early Foley catheter removal post colovesical fistula~     takedown. The hypothesis is that a cystogram showing no extravasation of contrast on~     postoperative day two will predict safe removal without increased morbidity.~      This is an uncontrolled, single arm trial. Patients who meet criteria to undergo either~     minimally invasive or open colovesical fistula takedown with sigmoid colectomy, without~     evidence of the need for bladder repair will be eligible to participate. An indwelling Foley~     catheter is placed intraoperative and continued postoperative. All patients who consent to~     participate would undergo a cystogram on postoperative day two. The cystogram will be~     conducted by a radiologist and technician well-trained in the techniques and interpretation~     of the study. The colorectal surgery enhanced recovery protocol will be followed on all~     patients with the exception of the cystogram being conducted on post-op day two. If there is~     no evidence of extravasation of dye is seen on the cystogram the Foley catheter will be~     removed. Patients will be monitored closely following catheter removal to ensure~     self-diuresis.~   "
3143|NCT03525743|"~     Collect hemodynamic data, such as heart rate, blood pressure, and cardiac output to help~     understand the effect of pre and post intubation.~   "
3144|NCT03525730|"~     A translational proof of concept study in humans on the primary research question whether~     novel anti-human immunodeficiency virus (HIV) latency strategies, including a BAF inhibitor~     and a histone deacetylase inhibitor, result in HIV reservoir reduction in HIV patients on~     antiretroviral therapy.~   "
3145|NCT03525717|"~     This study examines the impact of routine dinner time versus late dinner time on nocturnal~     metabolism. Specifically, investigators will examine plasma profiles of free fatty acids,~     glucose, insulin, triglycerides, and oxidation of dietary fat.~   "
3146|NCT03525691|"~     Acute Respiratory Distress Syndrome (ARDS) is associated with a mortality rate of 30 - 45 %~     and required invasive mechanical ventilation (MV) in almost 85 % of patients[1]. During~     controlled MV, driving pressure (i.e., the difference between end-inspiratory and~     end-expiratory airway pressure) depends of both tidal volume and respiratory system~     compliance. Either excessive tidal volume or reduced lung aeration may increase the driving~     pressure. ARDS patients receiving tidal volume of 6 ml/kg predicted body weight (PBW) and~     having a day-1 driving pressure ≥ 14 cmH2O have an increased risk of death in the~     hospital[2]. Seemly, in the LUNG SAFE observational cohort, ARDS patients having a day-1~     driving pressure < 11 cmH2O had the lowest risk of death in the hospital[1]. Hence, driving~     pressure acts as a major contributor of mortality in ARDS, and probably reflects excessive~     regional lung distension resulting in pro-inflammatory and fibrotic biological processes.~     Whether decreasing the driving pressure by an intervention change mortality remains an~     hypothesis; but one of means is to decrease the tidal volume from 6 to 4 ml/ kg predicted~     body weight (PBW). However, this strategy promotes hypercarbia, at constant respiratory rate,~     by decreasing the alveolar ventilation. In this setting, implementing an extracorporeal CO2~     removal (ECCO2R) therapy prevents from hypercarbia. A number of low-flow ECCO2R devices are~     now available and some of those use renal replacement therapy (RRT) platform. The~     investigators previously reported that combining a membrane oxygenator (0.65 m²) within a~     hemofiltration circuit provides efficacious low flow ECCO2R and blood purification in~     patients presenting with both ARDS and Acute Kidney injury[3].~      This study aims to investigate the efficacy of an original ECCO2R system combining a 0.67 m²~     membrane oxygenator (Lilliput 2, SORIN) inserted within a specific circuit (HP-X, BAXTER) and~     mounted on a RRT monitor (PrismafleX, BAXTER). Such a therapy only aims to provide~     decarboxylation but not blood purification and has the huge advantage to be potentially~     implemented in most ICUs without requiring a specific ECCO2R device. The study will consist~     in three periods:~        -  The first period will address the efficacy of this original ECCO2R system at tidal~          volume of 6 and 4 ml/kg PBW using an off-on-off design.~        -  The second part will investigate the effect of varying the sweep gas flow (0-2-4-6-8-10~          l/min) and the mixture of the sweep gas (Air/O2) on the CO2 removal rate.~        -  The third part will compare three ventilatory strategies applied in a crossover design:~             1. Minimal distension: Tidal volume 4 ml/kg PBW and positive end-expiratory pressure~               (PEEP) based on the ARDSNet PEEP/FiO2 table (ARMA).~             2. Maximal recruitment: 4 ml/kg PBW and PEEP adjusted to maintain a plateau pressure~               between 23 - 25 cmH2O.~             3. Standard: Tidal volume 6 ml/kg and PEEP based on the ARDSNet PEEP/FiO2 table~               (ARMA).~   "
3147|NCT03525678|"~     Multiple myeloma (MM) is an incurable malignancy and accounts for 1 percentage of all cancers~     and for 10% of all hematologic malignancies. Subjects with relapsed/refractory multiple~     myeloma (RRMM) will be included in this study, to evaluate the efficacy and safety of~     GSK2857916 monotherapy. Subjects will be treated with GSK2857916 monotherapy until disease~     progression or unacceptable toxicity and will be followed for Progression Free Survival (PFS)~     and Overall survival (OS). The subjects will be randomized to receive either frozen~     GSK2857916 at the dose of 2.5 milligram per kilogram (mg/kg) or 3.4 mg/kg Intravenous (IV).~     There will be an independent cohort of subjects who will receive a lyophilized configuration~     of GSK2857916. Approximately 155 subjects will be enrolled in the study of which 130 subjects~     will be enrolled to receive frozen GSK2857916 and 25 subjects will be enrolled in the~     independent lyophilized drug product cohort. The subjects who discontinued from the study~     other than Progressive disease (PD), disease evaluation will continue to be performed at~     3-week intervals until confirmed PD, death, start of a new anticancer treatment, withdrawal~     of consent, or end of the study whichever occurs first.~   "
3148|NCT03525665|"~     The study is designed as a retrospective analysis of patients with relapsed/refractory FL~     identified by the hematological centers of Italy.~   "
3149|NCT03525652|"~     This study is to evaluate the safety and efficacy of a therapeutic vaccine in combination~     with PD-1 knockout T cells in the treatment of advanced prostate cancer.~   "
3150|NCT03525639|"~     Patients with acute myocarditis (AM) usually experience spontaneous healing, but a~     considerable percentage of them evolve toward chronic cardiac impairment at long-term. The~     evolution toward dilated cardiomypathy (DCM) occurs in a subtle manner, frequently after an~     initial recover that mimics complete healing. Differences in the course of disease may~     reflect the course of underlying myocardial inflammation related to viral clearance or~     persistence and to the following autoimmunity response.~      New cardiac magnetic resonance (CMR) parameters are sensitive to myocardial inflammation.~     They may have a prognostic role and, in particular, our hypothesis is that a short-term~     monitoring with CMR (1 month) may identify the subgroup of patients at high risk to progress~     toward DCM. The trend of CMR parameters during the first month will be compared with the~     following outcome in 80 patients with AM.~      Results of this study will help to significantly improve management and outcome of patients~     with AM.~   "
3161|NCT03525496|"~     Iodinated contrast agents (ICA) are widely used in medical imaging. They provide however a~     risk of immediate hypersensitivity reactions (IHS). The risk of anaphylactic shock is~     estimated at 1/100 000 injections. Nevertheless, for safety reasons and to limit undesirable~     effects, the reintroduction tests are not conducted along similar lines to throughout scan or~     arteriography. Moreover, reintroduction protocols are actually not standardized, in terms of~     injected volume and doses progression. It should be evaluated the relevance of the~     reintroduction tests with injection of a low volume and ensure the absence of reaction during~     the ICA injections Under real conditions.~      The investigators are assuming that the realization of a provocation test by intravenous~     reintroduction with a reduced dose of ICA improves the predictive value of IHS in comparison~     with only cutaneous tests.~   "
3377|NCT03522649|"~     This is a randomized, open-label, multi-center, phase III study of Napabucasin plus bi-weekly~     FOLFIRI (Arm 1) vs. Napabucasin (Arm 2) for adult patients with metastatic CRC who have~     failed standard chemotherapy regimens.~   "
3151|NCT03525626|"~     Tourette Syndrome (TS) and Persistent Tic Disorder (PTD) are chronic and potentially~     disabling neurobiological conditions. Although a range of pharmacological and psychosocial~     treatments exists, a significant number of individuals either do not respond to the current~     treatments, find them unacceptable, or cannot access them. Thus, it is essential that~     researchers continue to pursue novel treatment approaches that can also be easily~     disseminated to those in need.~      Initial pilot data suggest that a mindfulness-based intervention may be beneficial for adults~     with tic disorders. In the present study, the researchers aim to further develop this~     mindfulness-based intervention, adapt it to be delivered online and pilot test the~     intervention with a small group of participants. The data from this pilot test will inform a~     subsequent randomized controlled trial comparing online mindfulness-based tic reduction to~     online psychoeducation, relaxation, and supportive therapy.~      The specific aim is to determine the feasibility and acceptability of Online~     Mindfulness-based Tic Reduction in 6 adults with TS or PTD.~      The researchers hypothesize that Online Mindfulness-based Tic Reduction will be feasible and~     acceptable to adults with tic disorders as measured by participant satisfaction, qualitative~     participant feedback, home practice compliance, dropout, and adverse events.~   "
3152|NCT03525613|"~     This is a 30-month, Phase III, multicenter, randomized, double-masked, sham-injection~     controlled study to assess the efficacy and safety of multiple IVT injections of APL-2 in~     subjects with GA secondary to AMD.~   "
3153|NCT03525600|"~     This is a 30-month, Phase III, multicenter, randomized, double-masked, sham-injection~     controlled study to assess the efficacy and safety of multiple IVT injections of APL-2 in~     subjects with GA secondary to AMD.~   "
3154|NCT03525587|"~     Adult Growth Hormone Deficiency (AGHD) is a recognized clinical entity but several barriers~     concerning patient-clinician communication, inadequate patients' awareness of the disease,~     low perceived benefit of replacement therapy and poor compliance still remains.~      The overall goal of the study is to improve AGHD management through a Smartphone app (MAGHD~     App: Manage Adult Growth Hormone Deficiency) integrated with a software framework able to~     merge patients daily data on physical activity, quality of life (QoL), and well-being with~     clinical data collected in institutional databases. The target population consists of 100~     patients with a previous diagnosis of AGHD, whether in treatment with growth hormone or not.~      In a prospective 24 months study, MAGHD App will be developed and connected to MAGHD~     Framework. This system will allow to integrate: 1) Physical Activity Data collected by~     wearable devices, 2) Patient Related Outcomes Data, periodically inserted by the patients~     through MAGHD App in response to questions extrapolated from validated questionnaires, 3) HCP~     Data registered in clinical databases and including medical history, biochemical and~     radiological examination. Data will converge in MAGHD Framework where they will be analyzed~     and used to create reports visible to patients (in MAGHD App) and clinicians (by a monitoring~     dashboard).~      The results are expected to positively influence AGHD management by involving patients in~     care process and giving clinicians a useful tool for clinical practice.~   "
3155|NCT03525574|"~     This study will evaluate the long-term safety and tolerability of VX-445 in triple~     combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis~     (CF) who are homozygous or heterozygous for the F508del mutation~   "
3156|NCT03525561|"~     The goals of the present study are to evaluate whether the most common, and effective,~     treatment for acute mountain sickness (AMS), acetazolamide (AZ), has a negative, positive, or~     no influence on exercise performance, cognitive performance, or manual dexterity in young~     healthy subjects during simulated altitude exposure. AMS represents a serious challenge to~     the health and performance of the Warfighter who may need to rapidly deploy to high altitude.~     However, there have been concerns that AZ might alter or impair endurance exercise~     performance, and possibly fine motor skills. These would represent major limitations to the~     use of this drug in a Warfighter who has a specific timeframe in which to accomplish mission~     tasks. In the present project, we will use exposure to simulated altitude in the USARIEM~     hypobaric chamber to quantify the impact, if any, of AZ on endurance exercise performance~     following rapid ascent to 3500 meters (m) in unacclimatized lowlander volunteers. The study~     will be conducted using a randomized, single-blind, placebo-controlled crossover study~     design. Ten male and female volunteers will complete one orientation day, one VO2peak day,~     three days of familiarization testing at sea level (SL), then two rounds of experimental~     testing. Each round of experimental testing consists of six days including four days to~     establish baseline euhydration, followed by a 30 hour (hr) exposure to 3500 m. Volunteers~     will have a two week break between experimental testing rounds for washout of any effects of~     altitude acclimation. During one experimental round, volunteers will take two doses of AZ~     each day (Phase 1: 250 mg/dose,500 mg/day, Phase 2: 125 mg/dose, 250 mg/day) starting 48 hr~     prior to their altitude exposure and continuing for the 30 hr stay at high altitude. During~     the other experimental condition, volunteers will be given a placebo at the same time points~     as the doses of AZ. Prior to altitude exposure, AMS will be evaluated and volunteers will~     then ascend to a simulated altitude of 3500 m, where they will remain for 30 hr. Volunteers~     will rest at altitude for an hr, after which they will complete an AMS questionnaire, resting~     ventilation measurements, provide a blood sample and complete cognitive and finger dexterity~     testing. Subjects will then perform 15 minutes (min) of steady state (SS) treadmill exercise~     at 40-45% of SL VO2peak and a 2 mile treadmill time trial (TT). Volunteers will stay~     overnight in the hypobaric chamber with research staff supervision. The following morning,~     metabolic and blood measurements will again be completed, after which volunteers will perform~     the exercise testing for a second time. Cognitive and finger dexterity testing will be~     performed before volunteers return to sea level (i.e., descend from the simulated~     altitude). The results of the proposed study will, for the first time, provide quantitative~     evidence regarding whether AZ treatment impairs endurance exercise performance in the context~     of a Warfighter-relevant endurance exercise task.~   "
3157|NCT03525548|"~     This study will evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor~     (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous for the~     F508del mutation (F/F)~   "
3158|NCT03525535|"~     The purpose of this study is to evaluate the prevalence rate of pulmonary embolism among not~     anticoagulated patient older than 75 years old admitted with syncope and hospitalised in the~     Toulon Hospital~   "
3159|NCT03525522|"~     This study evaluates the efficacy of Nd:Yttrium Aluminum Garnet Laser (Nd:YAG) Treatment of~     Lichen sclerosus in comparison with topical corticosteroid treatment. Half of participants~     will receive laser treatment and the other half corticosteroid treatment and the results will~     be followed for 6 months.~   "
3160|NCT03525509|"~     Epidurally administered opioid pain medications are important tools for postoperative pain~     control, but each agent has its own limitations. Methadone's properties suggest that it may~     provide a long duration of pain control with minimal side effects related to spread to the~     brain or absorption into the blood stream. In this study, the investigators aim to compare~     the relative pain relieving effects, markers of side effects, and concentrations in the blood~     of epidurally administered methadone as compared to another long-acting opioid which is~     commonly administered epidurally, morphine.~   "
3388|NCT03522506|"~     The purpose of this study is to determine the effect of TAK-925 after a single intravenous~     dose (compared to placebo) on promoting wakefulness as measured by sleep latency on the~     maintenance of wakefulness (MWT) in sleep-deprived healthy participants.~   "
3163|NCT03525470|"~     The influence of relatively small decreases in hydration status have been little studied. On~     two occasions subjects will be allowed to lose about 0,5% of their body weight and one~     occasion 300ml of water will be consumed. Functional MRI will be used to monitor brain~     functioning when performing a mental arithmetic task. Heart rate variability will be~     monitored and related to differences in brain functioning when water has and has not been~     drunk~   "
3164|NCT03525457|"~     This study will evaluate periodontal and systemic parameters of a cohort of chronic kidney~     disease (stage 5) patients, before and three months after non-surgical periodontal treatment.~     It does not consider a control group.~   "
3165|NCT03525444|"~     This study will evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor~     (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for~     F508del and a minimal function mutation (F/MF subjects).~   "
3166|NCT03525431|"~     The investigator aims to examine the clinical utility of WES, including assessment of a~     variety of clinical outcomes in undiagnosed pediatric cases.~   "
3167|NCT03525418|"~     This study is designed to assess the safety, tolerability, and efficacy of LMSCs as an~     adjunct therapy to the standard stage II (BDCPA) surgical intervention for HLHS. LMSCs will~     be delivered via intramyocardial injections~   "
3168|NCT03525405|"~     This is a Phase I, single-center, open-label, single-sequence, study evaluating the~     absorption, metabolism, and excretion of napabucasin in healthy adult male volunteers using a~     mixture 14C-radiolabeled and unlabeled material.~   "
3169|NCT03525392|"~     This study is being done because new treatment for patients with metastatic or locally~     advanced cancers expressing Neurotensin receptor 1 (NTSR1) is being studied. This study will~     be the first administration of a radioactive drug called 177Lu-3BP-227 to patients under~     controlled conditions of a clinical study. The purpose of this study is to evaluate how safe~     this investigational drug is as well to verify how well it is tolerated by patients after~     several intravenous administrations. In addition, we will evaluate the effect of the study~     drug on tumoral lesions and how it distributes throughout the body and at which rate it is~     removed from the body. Since 177Lu-3BP-227 is a radio-labelled drug, it will also be measured~     how the emitted radiation is distributed throughout the body (dosimetry).~      The study consists of a phase I with a dose escalation part (and potential expansion cohorts)~     and a phase II either in selected or over multiple indications in a basket approach. For the~     dose escalation part, it is anticipated that approximately 30 subjects will be included, in~     up to six escalation steps. In case of the implementation of phase I expansion cohorts, up to~     45 additional subjects will be enrolled. For the phase II, approximately 125 subjects (55~     Pancreatic ductal adenocarcinoma and 70 Colorectal cancer subjects) are planned to be~     enrolled for Basket trial or Optimal Simon's Two Stage design. If additional cohorts of~     subjects with Gastric cancer (GC) or Squamous-cell carcinoma of head and neck (SCCHN) in the~     phase II are to be studied, approximately 100 additional subjects will be enrolled.~   "
3170|NCT03525379|"~     This is a randomized, double-blind, placebo-controlled trial evaluating the effect of~     resveratrol on metabolic and skeletal muscle function. Patients will be randomized and~     allocated to either resveratrol or placebo, for 8 weeks with a 2-week run-in period before~     the intervention period (to ensure they are not on any nutritional supplement that contains~     resveratrol).~   "
3171|NCT03525366|"~     The purpose: To determine the safety and efficacy of Radiofrequency Ablation (RFA) HALO Ultra~     system in patients with Gastric Antral Vascular Ectasia patient cohort (GAVE).~      Research design: This is a prospective observational study. Procedure Used: Radiofrequency~     Ablation~      Risks and potential benefits:~      There are no risks associated with this study as it is a retrospective chart review.~     Potential benefits include the knowledge gained from this study which may be of help to~     patients in the future.~      Importance of knowledge that may reasonably be expected to result The knowledge gained from~     this study may be of help to other patients in the future.~   "
3172|NCT03525353|"~     Purpose: To compare the radiation exposure in patients during Endoscopic retrograde~     cholangiopancreatography (ERCP) done by Endoscopists formally trained in judicious use of~     fluoroscopy versus ERCPs done by Endoscopists without such formal training.~      Research design: This is an observational study to compare radiation exposure in patients~     during ERCPs based on formal training.~      Procedures to be used: None Risks and potential benefits There are no risks associated with~     this study as it is a retrospective chart review. Potential benefits include the knowledge~     gained from this study which may be of help to patients in the future.~      Importance of knowledge that may reasonably be expected to result The knowledge gained from~     this study may be of help to provide new insights and develop newer guidelines for radiation~     use in the future.~   "
3173|NCT03525340|"~     This study will develop and conduct a trans-specific peer navigation intervention in Brazil,~     which integrates the I-Care approach developed in South Africa with the Model of Gender~     Affirmation (GA), developed by the investigators to specifically address HIV prevention and~     care among trans women.~   "
3174|NCT03525327|"~     This study will include dance protocols for targeted therapeutic interventions measuring the~     effect of line dancing on cognitive, emotional and social well-being. The hypothesis is that~     participating in a one-hour line dance class once a week for twelve weeks will decrease~     stress levels and enhance participants' quality of life, as measured by interview survey~     questionnaires. Questionnaires will be administered at the beginning, mid-point, and end of~     the study. The objectives of the study are threefold: to quantify the beneficial effects of~     line dancing on quality of life including cognitive, emotional and social well-being; to~     identify how non-lifetime, amateur dance practitioners can benefit from dancing; and to~     demystify dance class and make it accessible to people who are not interested in learning a~     specific dance technique or concert/art dance. Line dancing is a cross-cultural,~     intergenerational activity that could fill this role.~   "
3175|NCT03525314|"~     The objective of this study is to examine how elongation of the Achilles tendon develops~     during the first year after rupture among patients with an Achilles tendon rupture, and how~     it affects physical function.~      The aim is to define a cutoff of acceptable elongation dividing the patients who obtain~     normal physical function (Limb Symmetry Index > 90%) from those who do not.~      Patients treated both operatively and non-operatively will be included.~   "
3176|NCT03525301|"~     Aim of the study is to assess efficacy of a short course radiation treatment in patients with~     symptomatic brain metastases from solid tumors~   "
3177|NCT03525288|"~     PSMA PET/CT has demonstrated higher sensitivity in detecting metastases than current imaging~     standard of care (CT and bone scan). [18F]DCFPyL is a promising high-sensitivity second~     generation PSMA-targeted urea-based PET probe. The hypothesis is that definitive radiotherapy~     (RT) informed by PSMA-PET findings will lead to improved cancer control outcomes compared to~     RT guided by conventional staging only. This study utilizes cmRCT design in companion to PERA~     (Partnership initiative for the Evaluation of technological innovation in Radiotherapy).~   "
3178|NCT03525275|"~     The purpose of this randomized clinical trial is to determine the effectiveness of~     Battlefield Acupuncture (BFA) in addition to usual post-surgical shoulder physical therapy~     compared to a standard shoulder rehabilitation program in reducing medication use and pain in~     patients who have undergone shoulder surgery. Measurements of medication (opioid, NSAID,~     acetaminophen, etc.) use (daily number of pills consumed), pain rating, patient specific~     functional scale and global rating of change will be taken at 24, 72 hours, 7 days, 14 days~     and at six weeks post-surgery. It is hypothesized that the inclusion of Battlefield~     Acupuncture will result in a decrease in medication use and post-surgical pain when compared~     to rehabilitation alone. The population for this study is male and female DoD beneficiaries,~     ages 17-55 (17 if cadet) that are not participating in other shoulder research studies. The~     subjects in the experimental group will receive Battlefield Acupuncture in addition to their~     respective post-surgical shoulder rehabilitation protocol.~   "
3179|NCT03525262|"~     Reduction of dose to or 'sparing' of neurovascular structures during stereotactic ablative~     body radiotherapy (SAbR) for localized prostate cancer will improve retention of sexual~     potency, while retaining excellent oncologic control and other secondary health-related~     quality of life (HRQOL) endpoints.~      Primary Objectives:~      • To compare the decline in patient health-related quality of life (HRQOL) instrument-defined~     erectile dysfunction following stereotactic ablative body radiotherapy (SAbR) with or without~     neurovascular sparing~      Secondary Objectives:~        -  Assess acute (within 9 months of treatment) and chronic (>9 months after treatment) SAbR~          related GU and GI toxicities, as well as serial impact on HRQOL metrics over time~        -  Assess biochemical progression free survival, local recurrence, disease-specific~          survival~        -  Evaluate the impact of neurovascular sparing on neurovascular element dose and the~          impact of rectal spacer use on neurovascular element sparing~        -  Evaluate quality of spacer placement and its effect on dose to neurovascular structures~        -  Evaluate rate local recurrence in the area of sparing adjacent to the neurovascular~          elements by biopsy in those with biochemical progression.~        -  Evaluate simplified 'practical' secondary HRQOL sexual potency endpoints that can be~          compared to prior literature.~   "
3180|NCT03525249|"~     Randomized, controlled, double-blind clinical trial of three parallel branches to analyze the~     efficacy of a supplement extracted from the internal membrane of the egg shell on the joint~     pain of patients diagnosed with osteoarthritis.~   "
3181|NCT03525236|"~     Oral nutritional supplements (ONS) are often prescribed for malnourished patients to help~     improve nutritional status. Commonly in cancer patients taste and smell alterations and side~     effects of treatment can affect the palatability and compliance to ONS. A variety of flavours~     and styles are available of ONS however research of the palatability of these in cancer~     patients is limited. This study aims to evaluate specific flavours created based on the taste~     changes occuring during treatment.~      We aim to evaluate the patient liking and evaluation of 5 flavors in 3 different types of~     flavour-sensations:~        -  Warming/spicy sensation: to trigger the senses and bring new sensations~        -  Cooling/fresh sensation: to have a fresh mouthfeel and lighter base perception~        -  Neutral: to avoid that patients experience additional flavour and let them the~          opportunity to mix it with other food~   "
3182|NCT03525223|"~     Salt (NaCl) intake is implicated in causing hypertension and cardiovascular disease, the~     commonest cause of death worldwide. The investigators recently established that Na+ is stored~     in tissues, bound to glycosaminoglycans (GAGs) in skin and muscle. The resulting local~     hypertonicity leads to immune cell-driven induction of local tissue electrolyte clearance via~     modulation of cutaneous lymph capillary density. To visualize these complex processes in man~     directly, the investigators established Na+ magnetic resonance imaging (23Na-MRI) and~     investigated Na+ stores in hemodialysis (HD) patients. Hemodialysis patients were~     sodium-overloaded and HD treatment lowered tissue Na+ stores in this study. The observed~     effects were highly variable and independent of Na+ or water removal from the body during a~     dialysis session. Tissue Na+ mobilization correlated with circulating vascular endothelial~     growth factor-C (VEGF-C). The investigators believe that excessive Na+ storage is a~     reversible condition and therefore susceptible for therapeutic interventions. The~     investigators hypothesize that lowering dialysate Na+ concentration may favorably affect~     accelerated tissue Na+ accumulation in hemodialysis patients. Besides, improved tissue Na+~     storage, osmostress-induced as well as pro-inflammatory immune cell response should be~     affected by such a revised dialysis management.~   "
3183|NCT03525210|"~     Patients with immunodeficiencies are at increased risk of developing persistent HPV infection~     and as such HPV-related disease (genital warts and cancer).~      In this study HIV-patients and SOT-patients will receive 3 doses of Gardasil®9. Safety,~     tolerability and immunogenicity will be evaluated up to one month following the 3rd and last~     dose of Gardasil®9.~   "
3196|NCT03525041|"~     Coronary artery bypass grafting(CABG) is an effective procedure in treating severe coronary~     artery disease(CAD). Optimal surgical method for CAD patients with functional ischemic mitral~     regurgitation(FIMR) is still controversial. This study will evaluate the different~     effectiveness of CABG plus mitral valve annuloplasty versus CABG alone on patients with~     moderate FIMR.~   "
3197|NCT03525028|"~     This project is designed to evaluating the use of combination therapy of glucocorticoid and~     metformin to decrease glucocorticoid side effects in participants with autoimmune~     uveitis.This study also aims to evaluate the anti-inflammatory and immunosuppressive effects~     of combination therapy.~   "
3198|NCT03525015|"~     The purpose of the study is to explore whether a decision aid booklet is more effective than~     the usual booklet for patients to make an informed choice on cataract surgery.~   "
3508|NCT03520946|"~     Interventional, prospective, randomized (1:1), controlled, open label, multicenter phase IIb~     study in patients with advanced metastatic colorectal cancer. The scope of the trial is to~     evaluate overall survival of either regimen (TAS102 +/- Ramucirumab) and evaluate safety and~     tolerability.~   "
3184|NCT03525197|"~     Resistance exercise training is a known stimulant for muscle protein synthesis (MPS) to~     occur, however the consumption of protein is also necessary to induce a shift towards a~     positive net protein balance. Other nutrients have been shown to be useful in the accretion~     of lean body mass and strength. Whey protein has been shown to improve muscle net protein~     balance after resistance exercise, more so when in conjunction with creatine. Furthermore,~     essential amino acids such as Leucine have been found to be important in moderating the shift~     towards a positive net protein balance, especially post-exercise and in combination with whey~     protein. Other vitamins and minerals have been shown to aid in permitting muscle protein~     synthesis rather than stimulating it, but are still necessary for optimal gains in~     hypertrophy. The effect of a multi-ingredient compound has rarely been investigated, and thus~     this study aims to combine whey protein, leucine, creatine, calcium citrate and vitamin D and~     test it in a resistance exercise training program over 12 weeks. Another novel aspect in this~     study will be testing this supplement against a placebo of equal amounts of protein and amino~     acids, the placebo will contain collagen protein and the non-essential amino acids alanine~     and glycine. Finally, this study will recruit both men and women (ages 18-30) to determine~     possible effects of the supplement on muscle hypertrophy in both sexes. We hypothesize that~     the synergistic effect of the ingredients in our supplement will induce hypertrophy to a~     larger degree than resistance exercise training with the placebo, and that these benefits~     will persist in both male and female participants.~   "
3185|NCT03525184|"~     Physical and psychological stress on Warfighters during training and operational missions can~     suppress immune responsiveness. Skin wound models can be used to detect changes in immune~     function. Investigators have recently demonstrated that relatively modest sleep disruption~     degrades immune response at the site of the disrupted skin barrier and delays the initial~     restoration of the skin barrier. Provision of additional protein and a multi-nutrient~     beverage during and after sleep restriction seems to mitigate decrements in local immune~     function, without producing detectable effects on initial restoration of the skin barrier.~     However, the prior work used a parallel-group study design and inter-subject variability may~     have made it more difficult to detect significant differences in skin barrier restoration~     between participants receiving the nutrition intervention versus those receiving the placebo.~     Therefore, the purpose of the proposed cross-over study is to test the efficacy of a~     multi-nutrient beverage and additional protein (1.5 g protein per kg body weight versus 0.9 g~     protein per kg body weight) on immune function and the initial restoration of the skin~     barrier consequent to an operational stressor (i.e., 72-h sleep restriction). The effect of~     sleep restriction on a friend-foe marksmanship task, flow state, and measures of cognitive~     and neuromotor performance, will be investigated as a sub-study (Appendix A). Additionally,~     the effects of sleep restriction on appetite physiology, eating behaviors and intestinal~     permeability will be tested. Research will be conducted in a laboratory environment using~     male and female Soldiers from the human research participant detachment (NSRDEC), or Soldiers~     or civilians at NSRDEC and/or USARIEM. Participants in the study described herein (n = 20)~     will be exposed, in a single-blind, cross-over design to a ~72 hour normal sleep control~     phase, and to 2 periods of ~72 hours of sleep restriction (monitored in laboratory with ~2-h~     sleep per night) during which time eight blisters will be induced via suction on~     participant's forearm and the top layer of blisters will be removed to reveal the dermal~     layer of skin. In the normal sleep trial, participants will consume ~0.9 g protein per kg~     body weight per day and a placebo beverage during (3 days). In the first sleep restriction~     trial, participants will consume ~0.9 g protein per kg body weight per day and a placebo~     beverage during (3 days) and after (5 days) sleep restriction; and, in the second sleep~     restriction trial (after at least two weeks wash-out) participants will instead consume ~1.5~     g protein per kg body weight and a multi-nutrient beverage (arginine: 20 g·d-1, glutamine: 30~     g·d-1, zinc sulfate: 24 mg·d-1, vitamin C: 400 mg·d-1, vitamin D3: 800 IU·d-1 and omega-3~     fatty acids: 1 g·d-1). Outcome measures include immune function (e.g., circulating markers of~     inflammation, cytokines at the blister site, and secretory immunoglobin A), skin barrier~     restoration time (by transepidermal water loss), subjective appetite ratings,~     appetite-mediating hormone concentrations, food preferences and cravings, gut microbiota~     composition, and intestinal permeability. Findings from this study will determine if a~     nutritional intervention attenuates the loss of immune responsiveness to a military relevant~     stressor (i.e., sleep restriction), and will determine the effects of acute sleep restriction~     on appetite, gut microbiota composition, and intestinal permeability.~   "
3186|NCT03525171|"~     Data about the impact of growth hormone treatment on insulin sensitivity in children are~     quite controversial, due to the different surrogate indexes that have been used, like~     Homa-IR, QUICKI, ISI-Matsuda or adipokine levels.~      The investigators aimed to evaluate insulin sensitivity through the euglycemic~     hyperinsulinemic clamp, considered the gold standard technique, in children affected by~     growth hormone deficiency and to compare the M-value with the most commonly used surrogate~     indexes of insulin sensitivity.~   "
3187|NCT03525158|"~     This research study is designed to investigate the use of a simple cognitive task (a memory~     cue and 10 minute time gap, followed by playing the computer game Tetris) for decreasing~     the number of intrusive memories of trauma among young refugees and asylum seekers. The~     design is a single case experimental AB design with or without optional replication (ABAB).~     Participants will aim to complete a no-intervention phase ('A': baseline phase) of one week~     followed by a one-week intervention phase ('B'), including a one-session intervention with a~     researcher comprising the simple cognitive task, followed by instructions to continue to use~     the technique self-guided in the subsequent week. Follow ups are conducted after each week to~     monitor the occurrence of intrusive memories of trauma in a pen-and-paper diary. It is~     predicted that participants will report fewer intrusive memories during the intervention~     phase than during the preceding baseline phase.~   "
3188|NCT03525145|"~     Platelet function testing has been considered for DAPT strategy adjustments to reduce the~     patient's risk of ischemia and bleeding. Although several previous RCT studies did not find~     any benefit in the detection of platelet function， the previous studies were mostly low-risk~     populations, and the P2Y12 receptor antagonists were simply clopidogrel, and the detection~     methods were relatively simple. Therefore, the need for platelet monitoring in high-risk ACS~     patients receiving new potent P2Y12 inhibitor ticagrelor, as well as the diagnostic threshold~     for different platelet function assays needs further study. In addition, due to the~     differences on the response to anti-platelet drugs between the East and the West, it is not~     appropriate to simply refer to the conclusion of the other party. However, as of now, there~     is no large sample randomized controlled study systematically focused on the applicability~     and status of platelet function tests in East Asian populations, especially Chinese~     populations.~   "
3189|NCT03525132|"~     The difficulty to measure blood flow in humans is connected with the necessity of using not~     invasive, reliable and reproducible techniques.~      There is several quantitative approaches to study eye blood flow which do not answer all~     these specifications. The laser doppler velocimetry allows movement speed measures but not~     vessel diameter. Optical coherence tomography doppler allows a simultaneous diameter and~     speed of travel (movement) measures, but presents a limited spatial resolution and thereby~     not easily reproducible vessel diameter measures.~      The investigators propose development of a technique allowing a simultaneous diameter and~     velocity measure of these vessels.~   "
3190|NCT03525119|"~     The purpose of this study is to investigate the immunogenicity and safety of the concomitant~     administration of TDV (subcutaneous [SC] injection) and of hepatitis A virus (HAV) vaccine~     (intramuscular [IM] injection) in healthy participants aged 18 to 60 years living in~     country(ies) non-endemic for both dengue and hepatitis.~   "
3191|NCT03525106|"~     This trial studies a positive psychology intervention designed to improve quality of life in~     stem cell transplant survivors and their caregivers. Positive psychology (PP) uses systematic~     exercises (e.g., gratitude letters, acts of kindness) to potentially boost levels of~     optimism, resilience, and life enjoyment. PP interventions are often enjoyable, easy to~     understand, and can be delivered via telephone. PP intervention may improve the quality of~     life of participants who have undergone a stem cell transplant or their caregivers.~   "
3192|NCT03525093|"~     This prospective controlled study aims to test a 5 week group hypnosis training as~     intervention to improve coping with perceived psychological stress.~   "
3193|NCT03525080|"~     For patient having a brain tumor, RMI is the standard exam for tumor characterization and~     determines initial surgery.~      The aim of this study is to assess if PET could provide additional information that could~     have an impact on surgery (indication and planification)~   "
3194|NCT03525067|"~     The aim of the present prospective study was, first, to verify the correlation between~     biliary colonization and postoperative infectious complications, and secondarily to asses~     morbidity and mortality for patients who underwent pancreaticoduodenectomy.~      The hypothesis is that a proportion of post-operative infections after~     pancreaticoduodenectomy is due to bacteria that colonize the bile ducts during the~     preoperative period.~   "
3195|NCT03525054|"~     Subtle speech disorganization could be predictive of a transition to schizophrenia of~     ultra-high-risk patients. The aim of our longitudinal multicenter cohort study is to identify~     specific linguistic markers of the psychotic transition to validate a french predictive model~     of this transition using computerized speech analysis techniques~   "
3199|NCT03525002|"~     Obesity is a widespread disease with increasing prevalence and associated with serious~     secondary complications. So far, the origin of the disease, regardless of an existing~     positive energy balance, is not fully understood. In addition to environmental factors, the~     genetic background plays an important role in the pathogenesis of obesity. Of common genetic~     polymorphisms, variants in the fat mass and obesity associated gene (FTO) locus have the~     highest effect size on body weight. Animal and first clinical studies indicate that FTO~     variants interact with dopamine signaling in the brain, thus influencing the risk of~     overweight. In fact, preliminary results indicate that enhancing dopamine signaling with the~     dopamine agonist bromocriptine, depending on the FTO genotype, either induces weight loss or~     has a neutral effect on body weight.~      The planned clinical trial serves to develop a genotype-specific and thus individualized~     therapy approach for obesity. The influence of dopamine agonist therapy on weight loss as a~     function of the FTO (rs8050136) genotype is to be tested.~      Here, the greatest weight loss is expected to occur in subjects carrying the homozygous~     risk-allele (AA).~      So far, there are only a few established conservative therapy forms of obesity, so that~     bariatric interventions with an increasing rate are necessary to achieve weight loss and thus~     a reduction in overall morbidity and mortality. Among the approved drug therapies for~     obesity, bromocriptine is commonly used. In addition, some interventions require injections.~     An early, conservative individualized, genotype-specific treatment with little side-effects~     would enable simple treatment of obesity.~      Study design: 150 obese (BMI > 30) subjects (50 / study center) will be enrolled in the~     study. The subjects will be stratified according to their FTO genotype (rs8050136). Subjects~     will be randomized into placebo or bromocriptine treatment group. Treatment will last for 18~     weeks and a follow-up will be performed 30 weeks after baseline.~   "
3200|NCT03524989|"~     Previous evidence showed hyperbaric oxygen can enhance aerobic and anaerobic performance~     during the exposure. The effect of continuous exposure of hyperbaric oxygen on performance~     was never evaluated.~   "
3201|NCT03524976|"~     The purpose of this study is assessment of safety, efficacy, and short-term outcome of SQUID™~     in the embolization of Dural Arteriovenous Fistula~   "
3202|NCT03524963|"~     This is a randomized, open-label, multiple-dose, two-sequence, two-period crossover study to~     to compare the safety/tolerability and pharmacokinetics between Pletaal SR Cap. and Cilostan~     CR Tab. in healthy volunteers~   "
3203|NCT03524950|"~     This study is about the effect of dexmedetomidine to the stress of pituitrin in laparoscopic~     hysteromyoma surgery. It is well known that pituitrin has been widespread used in the~     laparoscopic hysteromyoma surgery. Pituitrin includes oxytocin and vasopressin. Vasopressin~     increase body stress reaction through hypothalamic pituitary adrenal(HPA) axis. The HPA axis~     has has main role to the body stress reaction. Dexmedetomidine can inhibit the stress~     responses mediated by the sympathetic nervous system. Therefore,the effect of dexmedetomidine~     to the stress of pituitrin in laparoscopic hysteromyoma surgery is worth to be studied.~   "
3204|NCT03524937|"~     This is a double-blind, randomized, placebo-controlled, Phase 2b/3 two-part adaptive clinical~     trial. The trial is designed to investigate the pharmacokinetics and the efficacy of multiple~     dosing regimens of melatonin and to confirm the efficacy and safety of one dosing regimen in~     prevention for delirium.~   "
3205|NCT03524924|"~     Edoxaban, has shown in clinical registration trials a significant reduction of major bleeding~     compared to warfarin, especially in elderly patients. Efficacy and safety of edoxaban will be~     assessed in a cohort of very elderly patients (≥80 years of age) with NVAF. A secondary~     analysis will correlate outcomes with frailty defined according to SHARE-FI (not-frail,~     pre-frail or frail).~   "
3206|NCT03524911|"~     The Choose Health: Food, Fun, and Fitness (CHFFF) curriculum was evaluated in 3rd-5th~     graders, hypothesizing that change pre- to post- CHFFF education would be greater than in the~     same child during a delayed intervention control period.~   "
3207|NCT03524898|"~     A clinical trial with biweekly regimen of gemcitabine and nab-paclitaxel for Soft tissue~     sarcomas (STSs).~      A Promising antitumor activity in patients with metastatic STS has been reported with~     gemcitabine alone or in combination with taxanes including docetaxel and paclitaxel in~     pre-treated patients.~      Nab-paclitaxel is a 130-nm albumin-bound formulation of paclitaxel particles (Celgene,~     Summit, NJ) which was designed to eliminate the toxicities associated with Cremophor®-EL.~     Nab-paclitaxel at equal dose of paclitaxel showed increased antitumor activity, enhanced~     endothelial cell transport and 33% higher intra-tumor paclitaxel concentration in preclinical~     models of solid tumor xenografts promising an advantageous pharmacokinetic profile In~     sarcoma, nab-paclitaxel demonstrated preclinical anti-tumor activity in rhabdomyosarcoma~     xenograft model. Local relapsed tumors following paclitaxel treatment proved to be~     paclitaxel-resistant but remained responsive to nab-paclitaxel.~      These findings provide the rationale for further evaluation of nab-paclitaxel in combination~     with gemcitabine for soft tissue sarcoma treatment.~   "
3208|NCT03524885|"~     A study designed as a randomized controlled trial of parallel group design will be conducted~     at the Dental clinic of the University of Valencia to compare, considering different~     parameters, the rehabilitation with dental implants of atrophic posterior mandibles or~     maxillae using short implants or longer implants with vertical bone regeneration with GBR.~      The hypothesis of the study is that both treatment options will be successful to rehabilitate~     atrophic posterior mandibles or maxillae. Moreover, more surgical complications will be~     encountered in the bone regeneration group.~   "
3209|NCT03524872|"~     Together with materials and type of retention, the stability of the implant abutment~     connection represents one of the key factor for the success rate of an implant supported~     restoration. The recent diffusion of high quality and easy to use CAD/CAM systems has~     contributed to market launch of a number of competing companies that offer the so called~     clonical or compatible restorative components. Although they are claimed to be identical,~     the original abutments are supposed to present maximum accuracy and consequently lower~     microleakage.~      The aim of the present randomized controlled trial will be to analyze the implant abutment~     junction stability comparing implant-supported crowns restored with original components and~     compatible non-original abutments.~      The hypothesis is that original components will present significantly better stability than~     non-original abutments.~   "
3237|NCT03524508|"~     The purpose of this study is to evaluate the efficacy and safety of combination of~     fluorouracil/folinic acid and liposomal irinotecan(Onivyde) compared with fluoruracil/folinic~     acid in patients with metastatic biliary tract cancer which progressed on 1st line~     gemcitabine/cisplatin.~   "
3238|NCT03524495|"~     This study will primarily investigate the impacts of a one-time unconditional cash transfer~     on the well-being of recently homeless individuals.~      Secondary research questions will examine the impact of personal coaching for cash recipients~     and the impact of a workshop and coaching intervention for non-cash recipients.~   "
6274|NCT03484728|"~     The interaction between conditioned pain modulation and expectation in understanding the~     placebo effect of pain reduction~   "
3210|NCT03524859|"~     Introduction: In recent years, since the discovery of the cystic fibrosis (CF) transmembrane~     conductance regulator gene in human skeletal muscle, there appears to be growing interest in~     the measurement of muscle function in CF. One of the most used test in other chronic~     pulmonary diseases is the Sit-to-Stand test (STS) which consists of simply getting up from a~     chair. Although the main result of the STS test is the time developed during the task, the~     velocity and power generated during the task are considered very important variables to~     detect the functional decline. However, from our knowledge, no study has previously analyzed~     the differences in time, velocity and muscle power developed during the STS test in patients~     with CF and their respective healthy controls.~      Objectives: To compare the values gained from handgrip strength, walking speed and STS test~     (time, velocity, and muscle power) in a group of patients with CF and their respective~     healthy controls, and to analyze if these differences (if any) are associated with lung~     function in patients with CF.~      Methods: Cross-sectional study with a sample of 32 participants (16 patients diagnosed with~     CF and 16 healthy subjects) between 18-65 years old. The STS test will be measured through~     slow-motion video recording with a smartphone device (240 images per second) which will~     report the time, velocity and power generated during the test. Walking speed and handgrip~     strength will be also measured. Additionally, the relationship between the variables obtained~     during the test and the lung function of patients with CF will be analized.~   "
3211|NCT03524846|"~     To investigate the effect of ascorbic acid on angiographic restenosis after percutaneous~     transluminal angioplasty (PTA) for dysfunctional dialysis vascular access.~   "
3212|NCT03524833|"~     Helicobacter pylori (H. pylori) is the most common chronic bacterial infection in humans. The~     prevalence of H. pylori is about 30~50% in the Western adult population. It is estimated that~     about 50% of people are infected with this bacterium in Taiwan. Many studies have shown that~     H. pylori is an important causal factor of chronic gastritis, peptic ulcer disease, gastric~     cancer and gastric lymphoma. The World Health Organization classified H. pylori as a Group 1~     carcinogen in 1994. Endoscopic examination is indicated to confirm the above diagnosis for~     patient with H. pylori infection. Eradication of H. pylori infection reduces the risk of~     gastric cancer and recurrence of peptic ulcer disease. However, the eradication rate of~     clarithromycin-based triple therapy has been declining in recent years, probably related to~     the increasing resistant rate to clarithromycin. Several strategies have been proposed to~     overcome the declining eradication rate, including (1) extending the treatment duration of~     triple therapy to 14 days; (2) the use of bismuth quadruple therapy which contains bismuth, a~     proton pump inhibitor, and two antibiotics (usually metronidazole and tetracycline); (3)~     non-bismuth quadruple therapy (concomitant therapy) which contains a proton pump inhibitor~     and three antibiotics (usually amoxicillin, metronidazole, and clarithromycin); (4)~     sequential therapy which contains a proton pump inhibitor (PPI) plus amoxicillin for five~     days, followed by a PPI plus clarithromycin and tinidazole for another five days. The~     investigators aim to evaluate the efficacy of Metronidazole powder in the Intraluminal~     therapy for Helicobacter pylori infection while an endoscopic examination is performed.~   "
3213|NCT03524820|"~     This research is intended to check the benefit of treatment with cetuximab in metastatic~     colorectal cancer patients with wild type RAS as third line treatment. The advantage to the~     patients is unclear. This study will look if mutations in patients' blood area predictive~     marker for progression free time (FPT) in metastatic colorectal cancer patients treated with~     third line cetuximab. A predictive marker for FPT metastatic colorectal cancer patients~     treated with third line cetuximab will enable a reduction in the number of treated patients.~     Treatment only of patients with a positive marker is expected to prevent inefficient~     treatment which will reduce suffering for the patients and reduce unnecessary medical~     treatment.~   "
3214|NCT03524807|"~     This study is to evaluate the effect of pelvic floor muscle electrophysiologic therapy on~     enhanced recovery after gynecologic surgery,to solve muscle soreness and retention of urine~     after laparoscopy, and endometrial repair after electrosurgical resection of intrauterine~     adhesions.~   "
3215|NCT03524794|"~     Hepatitis C infection is a major cause of chronic liver disease and death with approximately~     3% of the world's population is infected with hepatitis C virus (HCV).~      New drug therapies called new direct-acting antivirals (DAAs) have been developed and have~     proven to be well tolerated with minimal side effects. The current costs of these agents are~     extremely high, however, they provide an opportunity to cure most patients of HCV if they can~     access and adhere to treatment. The bigger challenge is to engage and cure underserved groups~     who are not accessing medical care, or who have other complex problems, including~     homelessness, incarceration, and substance misuse problems.~      Strategies to improve HCV case detection and case management have much to learn from other~     infectious diseases. Tuberculosis (TB) disproportionately affects in large part the same~     group of individuals and community models of care have been used with great success.~     Strategies such as active case finding, community based screening and treatment, directly~     observed therapy (DOT) and peer support have all shown high rates of case detection and~     treatment completion.~      These strategies are currently being used by the Find&Treat team, UCLH NHS Trust and this~     study will ain in evaluating it's effectiveness. Previously used to aid homeless patients~     engage with treatment services for TB, it is now being used with other disease groups such as~     HCV.~      This observational study aims to assess the effectiveness of community based interventions~     with peer support to improve case detection, carry out pre-treatment assessments and assist~     underserved populations through HCV treatment by the Find&Treat service.~   "
3216|NCT03524781|"~     This study evaluates the treatment of newly diagnosed gastro-esophageal reflux disease in a~     Danish national cohort, comparing medical and surgical treatment.~   "
3217|NCT03524768|"~     The present study aims to evaluate the microvascular endothelial function of a single centre~     cohort of patients with the cardiac form of Chagas disease, and to search for associations~     with clinical and laboratory variables.~   "
3239|NCT03524482|"~     The purpose of this research is to study a smoking cessation program for adult smokers in~     Northeast Ohio. The study will also look at how different people respond to the program.~      The study includes completing surveys and receiving text messages to help participants become~     tobacco free.~   "
3521|NCT03520777|"~     The purpose of the study is to assess the feasibility of a Creative Artists Program~     intervention with epilepsy and headache patients admitted to Dartmouth-Hitchcock Medical~     Center for care by the Department of Neurology.~   "
3218|NCT03524755|"~     Cancer cachexia is a prevalent symptom of head and neck neoplasms. The reduction in skeletal~     muscle mass is one of the main characteristics which can lead to poor physical functioning.~     The purpose of this study was to determine the feasibility of progressive resistance training~     in cachectic head and neck cancer patients during radiotherapy in a pilot randomized~     controlled design.~      Baseline data for all participants were ascertained via medical records and patient~     interview. This included demographic information, Union internationale contre le~     cancer-status (UICC-status), comorbidities and the results of blood samples. Outcomes were~     measured at admission. One study coordinator completed all assessments to enhance patient~     compliance. Body weight loss percentage was calculated via the individuals' body weight 6~     months before (in retrospect) and the current body weight. Participants completed two~     questionnaires: The Multidimensional Fatigue Inventory and the Functional Assessment of~     Anorexia/Cachexia Therapy questionnaire. Six-Minute Walk Test was applied. To document~     changes in muscle force, strength of the functional muscle group for elbow flexion in supine~     position as well as of knee extension in sitting position (in each case right and left) was~     tested via hand-held dynamometry for isometric maximal muscle strength. Bioelectrical~     impedance analysis was executed to assess the adaption in body composition.~      The exercise intervention was undertaken in the hospitals department of physical and~     rehabilitation medicine and based on standardized but individualized training protocols. It~     consisted of a warm up period for 5 minutes on a bicycle ergometer or an upper body cycle~     with individual selectable wattage. A leg press, a latissimus pull-down and a chest press~     formed the three equipment supported core exercises. All exercises were performed with 8-12~     repetitions and 3 sets.~   "
3219|NCT03524742|"~     Recent global burden of disease analysis of DALYs, showed that dietary risk have the highest~     DALYs in ischemic stroke among behavioral risk factors. The MediDiet is associated with a~     decreased risk of total mortality as well as stroke incidence and mortality. Although not~     part of the classical Mediterranean diet they are another nutrient-dense source of MUFA, rich~     in vitamins, minerals, fiber, phytosterols and polyphenols extensively consumed in the~     Americas. Avocado-substituted diets significantly decrease cholesterol levels in diabetic and~     obese patients. Secondary stroke prevention studies with diet as an intervention are lacking~     and there is little information of what patients eat before or after an ischemic stroke.~     Lowering Low Density Cholesterol (LDL-C) levels decreases stroke recurrence. The aim is to~     determine the effect of a Mediterranean style diet based on Avocados on lipid profile~     particularly LDL-C in patients who have had an ischemic stroke and are at high recurrence~     risk.Methodology: Academic, open-label, blinded outcome assessment (PROBE design), clinical~     trial. Participants will be patients with an acute ischemic stroke admitted to Clínica~     Alemana de Santiago, who fulfills the eligibility criteria. Eligible patients will be~     randomly assigned to either diet intervention in a 1:1 ratio. The interventions will be: A)~     Avocado based Mediterranean diet with intake of ½ portion of a Hass avocado per day and B)~     Standard recommendation of low fat-high complex carbohydrate diet recommended by the National~     Cholesterol Education Program and the American Heart Association. The main efficacy outcome~     will be the level of plasma LDL-C level at 3 months of the dietary intervention. Secondary~     outcomes will be changes in: Levels of serum lipid profile, serum inflammation markers,~     glycemic control, anthropomorphic measures, stroke recurrence, cardiovascular events, adverse~     events, compliance. A sample size of 100 patients per group (200 in total) was estimated to~     provide 80% power and 5% level of significance with 10% loss and 5% crossover to detect the~     same difference in LDL-C after 3 months of intervention in patients with acute stroke. The~     investigators hypothesize that an Avocado based Mediterranean diet will significantly reduce~     levels of LDL-cholesterol at 3 months in patients who have suffered a recent acute ischemic~     stroke compared to the standard diet.~   "
3220|NCT03524729|"~     Ankle osteoarthritis (OA) is a painful, progressive condition that can severely limit~     physical activity and reduce quality of life. Rocker bottom (RB) shoes and ankle-foot~     orthoses (AFOs) are commonly used as non-surgical treatments for ankle OA. RB shoes have a~     curved sole in the toe to heel direction that may alleviate joint pain by reducing ankle~     range of motion (ROM). Similarly, AFOs may reduce joint motion by securing the foot and ankle~     within the ankle-foot orthosis (AFO) frame. This study aims to determine the ability of RB~     shoes and AFOs to improve mobility, by relieving pain and reducing joint ROM.~   "
3221|NCT03524716|"~     There is a critical need for physical activity interventions in CRC. The investigators have~     developed a digital health physical activity intervention, Smart Pace, which includes a~     wearable tracker (Fitbit) and text messaging and aims to have patients build up to 150 min/wk~     of moderate activity. In this study, the investigators propose to expand and improve Smart~     Pace, including: 1) enrolling patients during chemotherapy; 2) tailoring text messages to~     individual preferences and treatment timing; and 3) adding resources to support home-based~     exercise. The study is a 12-week pilot randomized controlled trial (RCT) to evaluate the~     feasibility of this novel digital health physical activity intervention among 48 CRC patients~     on chemotherapy. The specific aims are to: 1) Determine the feasibility of the intervention~     via adherence and attrition, and determine the acceptability of the intervention via~     questionnaires and semi-structured interviews . 2) Estimate the effect of the intervention~     vs. usual care on physical activity, QOL, and symptoms at 12-weeks . And 3) Explore the~     impact of the intervention vs. usual care on fitness, weight, waist circumference, and blood~     pressure at 12-weeks.~   "
3222|NCT03524703|"~     The aim of the study is to estimate the effect of chewing gum after anterior cervical fusion~     surgery on decreasing the severity of dysphagia in patients with mild-moderate dysphagia.~   "
3223|NCT03524690|"~     The effects of prolonged negative energy balance, commonly observed in sustained military~     training and combat operations, on systemic inflammatory responses has not been determined.~     To define the putative role of energy balance on inflammation and its downstream effects, we~     will conduct a controlled laboratory study that simulates extensive physiological stressors~     to determine if inflammation is exacerbated by underfeeding. This design will test the~     hypothesis that maintaining energy balance will attenuate systemic inflammation and its~     potential negative effects on whole-body metabolic homeostasis in response to physiological~     stressors.~   "
3224|NCT03524677|"~     Borderline resectable pancreatic cancers represent a wide spectrum of final histologic~     stages. A patient-tailored treatment plan requires an accurate preoperative staging.~     Currently more than 40% of patient taken to the OR are actually unresectable and more than~     one third of resected patient will need a vascular resection, of those approximately an half~     will eventually have a vascular infiltration.~      Among patients that meet upfront surgery some would have benefit of a neoadjuvant treatment~     and vice versa. Accuracy of preoperative staging is of primary importance in treatment~     decisional making. Due to its location, invasive preoperative diagnostic tests on pancreatic~     cancer are expensive and risky. Liquid biopsy provides a non-invasive signature of the tumor.~     Analyzing mutations on cell-free nucleic acids gives translational information on tumor~     biology and therefore on its clinic-pathological features and likely on its progression. This~     study would be the first -in our knowledge- analyzing the relationship of a pattern of 4~     major genes involved in pancreatic cancer progression on liquid biopsy and the T-stage, with~     particular attention to vascular invasion. A properly staged patient provides a better~     resource allocation, an optimal treatment plan and improves patient's outcomes.~   "
3240|NCT03524469|"~     The purpose of this study is to learn about how breast milk from mothers with~     insulin-resistance may be different. Investigators are specifically studying insulin~     concentrations in breast milk. Investigators are also studying how insulin in breast milk~     might affect a baby's intestines and pancreas.~   "
3225|NCT03524664|"~     The purpose of this study is to learn about the emotion regulation skills of children with~     fetal alcohol spectrum disorders (FASD) and different strategies that may improve these~     skills. This study is also testing whether a training program taught to caregivers is~     helpful.~      Children will be asked to:~        -  Complete a brief measure of verbal and nonverbal problem-solving skills.~        -  Play two computer games.~        -  Have their heart rate measured while completing a task that is designed to be mildly~          disappointing. Two ECG pads are placed on the chest with a small recorder.~        -  Play or relax with study staff while you are finishing caregiver activities.~      Caregivers will be asked to complete interviews and questionnaires about:~        -  the child's background, including any past stressful experiences~        -  the child's behavior and how s/he handles emotions~        -  caregiver views on the child's emotions and their own~        -  caregiver relationship with the child~        -  Stress caregivers experience as a parent~   "
3226|NCT03524651|"~     The scope of this study is to compare the efficacy of the new oral formulation of Fe-ASP to~     oral ferrous sulfate in patients with iron deficiency anemia (IDA) for the restoration of~     decreased circulating Hb. The improvement of symptoms of anemia, the restoration of~     biomarkers of iron deficiency into the normal range and the incidence of GI tract side~     effects are the study secondary endpoints.~   "
3227|NCT03524638|"~     Determine whether the administration of VSL3 after colorectal surgery has any effect on~     anastomotic leak and local recurrence~   "
3228|NCT03524625|"~     Atrial Fibrillation(AF) is one of the most common abnormal heart rhythms and approximately 3%~     of the general population have AF. The prevalence increases with age of the population and is~     increased in people with diabetes, hypertension and those who are overweight. AF is a major~     risk factor for stroke; people with AF are five times more likely to suffer an ischaemic~     stroke; however this can be reduced significantly with appropriate interventions which~     depends on detection of the abnormal rhythm. Although the National Institute of Health and~     Care Excellence (NICE) currently recommends screening patients with symptoms of AF, including~     syncope, heart palpitations, and chest discomfort, as well as patients who have suffered a~     stroke or heart attack, many patients remain symptomless and are not managed for their~     increased stroke risk. Guidelines for AF screening include manual palpation of a peripheral~     pulse, followed up by an ECG for patients who have an irregular pulse. Although almost all~     patients with AF have an irregular pulse, only about 12 in 100 patients with an irregular~     pulse have AF. Use of an improved screening tool for AF could both cut down the number of~     people undergoing unnecessary ECGs, and also lead the way for a wider screening programme for~     AF. The aim of this study is to investigate the sensitivity and specificity of a new ECG like~     device for the detection of AF, the Plessey imPulse. Participants referred or admitted to~     secondary care with stroke symptoms and other indicators of increased prevalence of AF will~     be recruited. Participants will undergo three methods of AF screening, a peripheral pulse, a~     lead-one like ECG using the imPulse device, and the gold-standard for AF detection, a 12-lead~     ECG. By comparing to the ECG results specificity and sensitivity will be established for both~     methods in this population.~   "
3229|NCT03524612|"~     This study will assess the ability of eltrombopag to induce sustained treatment-free~     remission in ITP subjects who relapsed or failed to respond to an initial treatment with~     steroids.~      There is limited, mainly retrospective evidence that earlier use of eltrombopag after ITP~     diagnosis, will allow a larger proportion of subjects to achieve sustained remission after~     tapering off drug. Clinically there is a need for a less toxic regimen that will provide~     responses and sustained remission with a shorter treatment interval. This trial is designed~     to assess this.~   "
3230|NCT03524599|"~     A quasi-experimental study will compare primary health care-based prevention and management~     of alcohol use disorder, operationalized by heavy drinking, in three intervention cities from~     Colombia, Mexico and Peru with three comparator cities from the same countries. In the~     implementation cities, primary health care units (PHCUs) will receive training embedded~     within ongoing supportive municipal action over an 18-month implementation period. In the~     comparator cities, practice as usual will continue at both municipal and PHCU levels. The~     primary outcome will be the proportion of consulting adult patients intervened with (screened~     and advice given to screen positives).~   "
3231|NCT03524586|"~     This study evaluates the endotracheal tube cuff pressure of a taper-guard cuffed tube during~     tympanoplasty with ipsilateral rotation of head, compared to the contralateral rotation of~     head.~      The investigators will performed the ipsilateral rotation of head against the fixed tube in~     half of participants or the contralateral rotation of head in the other half.~   "
3232|NCT03524573|"~     The DELAY Trial will compare immediate (< 6 hours from decision to operate) to delayed~     (Surgery to take place the following morning) appendectomy in adult patients presenting to~     the emergency department with suspected acute appendicitis. The primary outcome will be 30~     day postoperative complications.~   "
3233|NCT03524560|"~     Patients who were 65 years old or older and applied to Melek Hatun family practice center~     were enrolled in the study. All patients were seen either in our center or in their homes,~     and informed consents were obtained. Comprehensive Geriatric Assessment (CGA) was performed~     for each subject. Data were evaluated by PASW 17. The amount of medicines that the patient~     used everyday (DDC) was dependent variable. Relationships between DDC and other continuous~     variables were examined by Pearson's correlation. For categorical independent variables,~     t-tests were performed.~   "
3234|NCT03524547|"~     In this study, investigators will compare the efficacy of two shapes of endotracheal tube~     molded by stylet in endotracheal intubation using videolaryngoscope (McGrath MAC®). The~     participants will randomly be divided into two groups; J-shaped tube and 60-degrees-curved~     tube.~   "
3235|NCT03524534|"~     This study is a pragmatic randomized clinical trial to determine the effectiveness of two~     strategies of early follow-up in adults after hospitalization for heart failure: telephone~     follow-up with a heart failure care manager vs. in-person clinic visit with their primary~     care provider. The primary outcomes during 30-day follow-up will include readmission for~     heart failure, death and readmission for any cause. The study team will randomly assign 2400~     patients during a 15-month period in a 1-to-1 ratio to either an initial structured telephone~     call with a heart failure care manager or an in-person primary care clinic visit within 7~     days of discharge. A secondary goal is to increase the rate of any follow-up within 7 days of~     discharge to greater than 90 percent among all eligible patients.~   "
3236|NCT03524521|"~     Body-weight based interval training (IT) performed 3 times per week will lead to reductions~     in abdominal adiposity and reduce overall body fat percentage in overweight and obese~     sedentary adults more effectively than moderate intensity continuous training (MICT).~     Body-weight interval training will improve exercise capacity (peak VO2) in overweight/obese~     adults.~   "
3269|NCT03524092|"~     The purpose of this study is to evaluate the efficacy and safety of mirikizumab as~     maintenance therapy in participants who completed prior 12-week induction study AMAN~     (NCT03518086).~   "
3241|NCT03524456|"~     Hypertension is a public health problem worldwide, being responsible for 9.4 million deaths~     worldwide each year, as well as contributing to the burden of coronary, cerebrovascular,~     renal diseases, among others. The monitoring of blood pressure at home has gained importance~     in recent years, being related to adherence to treatment, as well as in the prevention of~     complications and optimization of pressure levels; In the same way, the use of information~     and communication technologies (ICT) in health has contributed to the improvement of~     communication systems by providing alternative tele-monitoring in this type of diseases.~      Objective:~      To evaluate the impact of tele-monitoring at home through tensiometers with integrated SMS~     system (text message), for the sending and recording of blood pressure and heart rate data in~     the primary care setting.~      Methods:~      A randomized controlled trial will be conducted, evaluating the intervention with the~     integrated blood pressure device with SMS capability, comparing it with the standard care.~     After a follow-up of 1 month, the effect on the values of systolic and diastolic blood~     pressure will be evaluated, as well as the adherence to treatment and complications related~     to arterial hypertension. A sample number of 20 participants per group was calculated, with a~     significance of 95% and a power of 80%, to detect a minimum significant difference of 10~     mmHg.~   "
3242|NCT03524443|"~     Alexithymia is often found in patients suffering from anorexia nervosa or from bulimia.~     Art-therapy is widely used in this indication without there is a study in the literature~     assessing it. ALEXART is an observational prospective multicenter cohort, assessing the~     effect at 3 months of art therapy on alexithymia, in patients presenting anorexia nervosa or~     bulimia.~   "
3243|NCT03524430|"~     The current study (BREVITY) aims to provide validation results of RNA Disruption Assay (RDA)~     as a tumour response assessment tool that uses tumour core biopsies at ~2 weeks after the~     initiation of neoadjuvant chemotherapy.~   "
3244|NCT03524417|"~     No study was conducted to evaluate the rabies neutralizing antibody titers after RIG~     injection on day 7. The only study that has supported the delay of RIG administration was~     done in 1996 by our institute, of which RIG was given on day 5 with the original Thai Red~     Cross intradermal regimen (2-2-2-0-1-1).~   "
3245|NCT03524404|"~     The purpose of this pilot study is to test the feasibility of implementing a telehealth~     adaption of the Diabetes Prevention Program (DPP) intervention among 30 NYC senior center~     members. The intervention will be conducted through 6 weekly webinars with a certified DPP~     coach. Participants will receive a binder and physical activity tracker to complete~     self-monitoring of diet and physical activity. The primary outcome is feasibility and~     acceptability of the intervention measured by workshop attendance and focus group feedback.~     Secondary outcomes include changes in diet, physical activity, and weight.~   "
3246|NCT03524391|"~     Cancer is second leading cause of death worldwide. The psychological issues are related to~     all stages of the disease affecting outcome of treatment and overall quality of life. The~     study evaluated the effectiveness of yoga counselling among prostate cancer patients on their~     quality of life and psychological outcomes.~   "
3247|NCT03524378|"~     Chronic low back pain has been identified as a major problem for seafood and agricultural~     workers, and is known to affect worker health and productivity. The aims of this study are~     to: 1) identify modifiable, sector-specific, work and movement solutions with the potential~     to reduce the burden or severity of chronic lower back pain in clam workers and 2) determine~     the extent that participants adopt identified solution(s), and the impact on functional~     difficulty and low back pain.~   "
3248|NCT03524365|"~     Bariatric-metabolic surgery is effective in treating the cluster of conditions forming the~     metabolic syndrome, strictly associated with NAFLD and NASH. Recently, we and other authors~     have shown also in the long term (up 5 years) with randomized-controlled trials (RCTs) that~     bariatric-metabolic surgery allows remission of type 2 diabetes and obesity reduction, which~     are the two major pathogenetic factors of NASH development, with maintenance of weight loss.~      Few small and mainly retrospective studies have shown that bariatric surgery is effective in~     improving NASH histologic picture in obese subjects.~      The aim of our proposal is to conduct a 3 arm single centre, superiority, RCT comparing~     Roux-en-Y Gastric Bypass (RYGB) with Sleeve Gastrectomy (SG) and with Intensive Lifestyle~     Modifications (ILM) for the treatment of Non-Alcoholic Steato-Hepatitis.~   "
3249|NCT03524352|"~     Ulcerative colitis (UC) is a chronic inflammatory digestive (IBD) disease medically treated~     with corticosteroids, aminosalicylates, immunomodulators, and biologics. Almost one third of~     UC patients will require surgical interventions because of fulminant colitis, dysplasia,~     cancer, or medical refractory diseases. Restorative proctocolectomy with ileal pouch-anal~     anastomosis (IPAA) is the current standard surgical intervention. Anastomotic leak, pouch~     failure, pelvic sepsis, and pouch ischemia can occur after the procedure, but the most common~     long-term complication is pouchitis, an idiopathic inflammatory condition involving the ileal~     reservoir. Symptoms of pouchitis are increased stool frequency, urgency, incontinence, bloody~     stools, abdominal or pelvic discomfort, fatigue, malaise, and fever. The prevalence of~     pouchitis ranges from 23 to 46 %, with an annual incidence up to 40 %. Though the majority of~     initial cases of pouchitis are easily managed with a short course of antibiotics, in about 5~     to 15 % of cases, inflammation of the pouch becomes chronic with very few treatments~     available.~      Fecal microbiota transplantation (FMT) is a novel therapy to transfer normal intestinal flora~     from a healthy donor to a patient with a medical condition potentially caused by disrupted~     homeostasis of intestinal microbiota or dysbiosis. FMT has been widely used in refractory~     Clostridium difficile infection (CDI) and recently it has gained popularity for treatment of~     inflammatory bowel disease (IBD). Previous studies suggested that manipulating the~     composition of intestinal flora through antibiotics, probiotics, and prebiotic achieved~     significant results for treating acute episodes of UC-associated pouchitis. However,~     currently there is no established effective treatment for chronic antibiotic dependent~     pouchitis. Our project aims to evaluate the delay of relapse in chronic recurrent pouchitis~     after FMT versus sham transplantation.~   "
3250|NCT03524339|"~     This is a placebo controlled randomized controlled trial of perioperative use of tamsulosin~     to prevent postoperative urinary retention in female pelvic reconstructive surgery.~   "
3251|NCT03524326|"~     This is a phase I study, which tests the safety of different doses of lenvatinib in~     combination with cetuximab, to see which dose is the safest in people. This study will help~     find out if lenvatinib and cetuximab is a safe and useful combination for treating patients~     with HNSCC and cSCC.~   "
3270|NCT03524079|"~     The study purpose is to evaluate the morphological and functional characteristics of the~     right ventricle before and after ajmaline in patients diagnosed with Brugada syndrome.~   "
3271|NCT03524066|"~     The aim of the present study is to increase the general understanding of lung PK of selected~     compounds by sampling epithelial lining fluid ELF and lung tissue.~   "
3252|NCT03524313|"~     Hemodynamic monitoring, especially cardiac output assessment, is a key feature for the~     management of critically ill patients. Although the use of invasive methods, such as~     thermodilution with a pulmonary artery catheter, remains the GOLD standard for the evaluation~     of the cardiac output, several non-invasive techniques are currently used in practice. An~     acceptable estimation of the cardiac output can be made by standard transthoracic~     echocardiography. Cardiac output can be calculated from subaortic velocity time integral~     (VTI). However, this technique requires a trained operator and depends on the echogenicity of~     the patient. The best method for assessing cardiac output depends on the patient's needs, the~     clinical scenario and the physician's experience with the monitoring device itself. No simple~     and rapid tool currently exist for assessing cardiac output in critically ill patients.~      The measurement of end-tidal carbon dioxide (EtCO2) used in routine in critically ill~     patients requiring mechanical ventilation could be an interesting alternative. Indeed, the~     amount of carbon dioxide (CO2) exhaled depends on the production of CO2 by the body, the~     pulmonary blood flow (corresponding to cardiac output) and its elimination by alveolar~     ventilation. In controlled ventilation, ie for constant alveolar ventilation, EtCO2 should~     therefore depend only on cardiac output. It has been shown in a porcine model that EtCO2 and~     cardiac output are strongly related under stable respiratory and metabolic conditions. In~     humans, only the variation of EtCO2 after volume expansion has been studied and EtCO2 seems~     to reflect changes in cardiac output. Nevertheless, the usefulness of EtCO2 in assessing~     cardiac output has never been evaluated.~      The objective of this study is therefore to determine the relationship between EtCO2 and~     cardiac output evaluated by the measurement of VTI in critically ill patients.~   "
3253|NCT03524300|"~     The purpose of this study is to explore the clinical efficacy between robotic and~     laparoscopic total gastrectomy in patients with clinical Stage I gastric cancer~   "
3254|NCT03524287|"~     The purpose of this study is to explore the clinical Efficacy of robotic assisted~     spleen-preserving No. 10 lymph node dissection for patients with locally advanced upper third~     gastric adenocarcinoma（cT2-4a, N-/+, M0）.~   "
3255|NCT03524274|"~     This is a phase II Randomized comparison clinical trial of activated CIK armed with~     anti-CD3-MUC1 bispecific antibody for advanced colorectal cancer. And the aim of this~     research is to study the clinical efficacy and safety of activated CIK armed with~     anti-CD3-MUC1 bispecific antibody for colorectal cancer.~   "
3256|NCT03524261|"~     This is a phase II Randomized comparison clinical trial of activated CIK armed with~     anti-CD3-MUC1 bispecific antibody for advanced breast cancer. And the aim of this research is~     to study the clinical efficacy and safety of activated CIK armed with anti-CD3-MUC1~     bispecific antibody for breast cancer.~   "
3257|NCT03524248|"~     The goal is to achieve the maximal radiotherapy tumor dose while sparing the health tissue~     and critical structures. On-board cone-beam CT (CBCT) scans are routinely acquired prior to~     dose delivery and matched with simulation CT at the planned treatment positions. Thus, setup~     or motion errors can be detected and corrected. However, CBCT is not available for situations~     with gantry collisions such as WBI and TSEB. More importantly, CBCT cannot reveal any~     irregular respiration or body movement during beam-on time. Thus, it is essential to develop~     a real-time image system that can detect organ/body motion during beam-on time, and correlate~     simulation-planning images with prior treatment CBCT images.In this proposed clinical trial,~     we will cooperate with a 3D camera company (Xigen LLC) to develop novel 4D video imaging~     techniques and validate the feasibility and accuracy of 4D video image guidance in~     correlation with 4D CT/CBCT useful for advanced IGRT.~   "
3258|NCT03524235|"~     This study seeks to examine the investigational use of the conditioning regimen~     (bendamustine, fludarabine, and retiuximab) prior to haplo peripheral blood allogeneic stem~     cell transplantation with PTCy. The study will also test the investigational use of~     CD56-enriched Donor Lymphocyte Infusion to see if this treatment is safe and whether or not~     it will help patients achieve better outcomes post-transplant, including reduced risk of~     Graft Versus Host Disease (GVHD) and preventing disease relapse.~   "
3259|NCT03524222|"~     The investigators propose a home hospital model of care that substitutes for treatment in an~     acute care hospital. Limited studies of the home hospital model have demonstrated that a~     sizeable proportion of acute care can be delivered in the home with equal quality and safety,~     reduced cost, and improved patient experience.~   "
3260|NCT03524209|"~     Pyogenic spondylitis in adults is usually treated by antibiotics according to bacteria~     evidenced in a diagnostic intervertebral disc puncture. Brace treatment is associated in~     patients presenting back pain and a risk for vertebral body collapse due to infection with~     subsequent kyphotic deformity of the thoracolumbar spine. Percutaneous minimally invasive~     posterior spinal instrumentation has evolved over the last decade and indications in~     infections arouse over the last years. This procedure is interesting as it is performed~     through small skin incisions only. It avoids paravertebral muscle dissection and thus limits~     intraoperative bleeding and access morbidity. Recent retrospective data suggests that this~     internal fixation represents a theoretical advantage over brace treatment by lowering back~     pain and increasing patient's quality of life in the short run, up to 3 months, but no~     randomized study was published. The patient's autonomy, including walking ability and daily~     activities, might improve more rapidly after a percutaneous procedure. Additionally, the~     sagittal alignment of the thoracolumbar spine could be better maintained by internal~     fixation, which might prevent progression into kyphosis and improve long-term outcome. The~     hypothesis is the superiority of percutaneous minimally invasive instrumentation on brace~     treatment in term of quality of life, back pain and quality of osseous healing.~   "
3261|NCT03524196|"~     Mental health problems such as anxiety and depression are common. Services are finding it~     difficult to treat people quickly. This has led to computers being used to treat common~     problems.~      Research has shown that around half of people who have mental health problems have more than~     one difficulty (e.g.low mood and worry). Many of the computer interventions available are not~     designed to work with more than one problem at a time. This can make them less helpful and~     can lead to people stopping intervention early.~      A talking intervention called the Method of Levels is suitable for people with more than one~     problem. A new computer programme that aims to emulate this type of intervention is called~     Manage Your Life Online (MYLO). MYLO is accessed online. Users have conversations with MYLO~     by typing on a computer keyboard. MYLO aims to help people to talk freely and experience~     feelings related to a problem. In this way, people can find new ways of thinking about their~     problem. MYLO can be used as often as the person wants.~      MYLO has been tested twice before with student volunteers. Participants said that it was~     helpful in solving an everyday problem. The investigators are not aware of any research that~     has tested a programme like MYLO for people experiencing mental health problems.~      24 adult service users will be recruited from Self Help Services, a participating~     organisation in Manchester contracted to provide primary care mental health provision for NHS~     patients. Participants will use MYLO for a two week period.~      The investigators aim to conduct a detailed examination of what questions service users find~     helpful and unhelpful in intervention with MYLO and whether service user perceptions are~     related to key mechanisms of psychological change identified in MOL. The information gathered~     from this study will help to increase understanding of how this type of intervention works~     and what makes it most helpful to service users. These findings will inform improvements to~     the MYLO programme to improve its acceptability to service users.~   "
3272|NCT03524053|"~     This study will compare the inflammatory response in induced vs inhibited exercise induced~     bronchoconstriction (EIB) in patients with a medical diagnosis of asthma/EIB. Urinary and~     plasma samples will be analysed to compare the mediator release in each condition, alongside~     changes in lung function.~   "
3262|NCT03524183|"~     The VFB Ecosystem capitalizes on digital technologies' ability to connect parents and~     children, allowing parents to actively support their child's physical activity, even when~     parents cannot be present. The VFB is a kiosk-based system that houses a virtual dog~     programmed to allow children to set self-determined physical activity goals. The children~     wear Fitbits while performing physical activity. Using the unique data embedded in the~     Fitbit, the kiosk is able to detect each individual child and automatically connect him or~     her to a unique, personalized virtual dog. Physical activity data is transmitted~     automatically from the Fitbit to the kiosk when the child approaches, and the virtual dog~     provides accurate evaluations of whether the child met the self-determined physical activity~     goal, offering words of encouragement and physical activity support. The virtual pet~     functions as a personalized fitness buddy to encourage children to set and meet physical~     activity goals, promote physical activity self-efficacy, and foster mutually supportive~     relationships among children, parents, and the virtual pet. This will be particularly helpful~     for children who receive insufficient amounts of social support in their current environment.~      Concurrently, the kiosk sends a text message to parents on the child's physical activity~     progress. Parents are then able to send words of encouragement and communicate with their~     children via the kiosk, using the text messaging feature of their mobile phones. Thus, even~     when the parent is not with the child, the virtual pet is designed to serve as a coordinating~     focus for facilitating parent-child communication. Parents will also receive text messages~     from the kiosk with a security code to access a website that provides detailed records of the~     child's physical activity over time.~   "
3263|NCT03524170|"~     The goal of this clinical research study is to find the highest tolerable dose of M7824~     (MSB0011359C) that can be given with radiation therapy to patients with estrogen and/or~     progesterone receptor (HR) positive, HER2-negative breast cancer that is metastatic (has~     spread). The safety and tolerability of MSB0011359C will also be studied.~      Researchers also want to learn more about how certain immune cells may change when~     MSB0011359C in given in combination with radiation therapy. The effect of the study treatment~     combination will also be studied.~      This is an investigational study. MSB0011359C is not FDA approved or commercially available.~     It is currently being used for research purposes only.~      Radiation therapy is part of standard of care for many breast cancer patients.~      The study doctor can describe how the study drug and radiation therapy are designed to work.~      Up to 20 participants will be enrolled in this study. All will take part at MD Anderson.~   "
3264|NCT03524157|"~     Phase I clinical study, to evaluate the safety and tolerability of the preservative-free~     ophthalmic solution PRO-087 versus Xyel Ofteno® and Systane Ultra®, on the ocular surface of~     ophthalmological and clinically healthy subjects.~      Objective: To evaluate the safety and tolerability of the preservative-free formulation~     PRO-087 manufactured by Laboratorios Sophia S.A. of C.V. on the ocular surface of clinically~     healthy subjects.~      Hypothesis:~      The ophthalmic solution PRO-087 presents a profile of safety and tolerability similar to~     comparators in healthy subjects~      Methodology:~      Phase I clinical trial, controlled, of parallel groups, double blind, randomized,~     exploratory.~   "
3265|NCT03524144|"~     A cross-sectional study was performed from 2017 to 2018. Consecutive Crohn's disease patients~     diagnosed in the Inflammatory bowel disease center of the Sixth Affiliated Hospital of Sun~     Yat-sen University were recruited. All patients underwent upper gastrointestinal endoscopy~     and biopsy by two defined endoscopists and two pathologists, the basic information were~     collected at the same time, in order to assess the prevalence of upper gastrointestinal~     involvement, and determine the role of upper gastrointestinal endoscopy in adult Crohn's~     disease patients, irrespective of upper gastrointestinal symptoms.~   "
3266|NCT03524131|"~     The National Health Service (NHS) Health Check is a significant part of the strategy to~     tackle premature mortality and promote healthy lifestyles. Public Health England aspires to~     an uptake rate of 75% but national uptake is less than 50%. This study aims to assess the~     impact of two new behaviourally informed NHS Health Check leaflets on the uptake of NHS~     Health Checks, by randomizing patients in Lewisham and North East Lincolnshire to the~     different leaflets and comparing patient-level uptake data. The study will test whether a~     shorter risk-framed leaflet or a shorter benefits-framed leaflet will be more effective than~     the current national leaflet at encouraging uptake of the NHS Health Check.~   "
3267|NCT03524118|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and~     incidence of anti-drug antibodies (ADAs) of single ascending doses of MK-1654 in healthy~     pre-term (born at 29 to 35 weeks gestational age) and full-term (born at >35 weeks~     gestational age) infants. Key safety and tolerability variables will be reviewed after each~     panel prior to administering the next-highest dose.~   "
3268|NCT03524105|"~     The current study examines the impact of ParentCorps in high-poverty Early Education Centers~     in New York City (NYC). The study is conducted within the context of the NYC Department of~     Education (DOE) Pre-K Thrive initiative. As part of this initiative, the Center for Early~     Childhood Health and Development (CEHD) at NYU Langone Health is implementing services to~     strengthen family engagement and support parents and teachers in building safe, nurturing and~     predictable environments for young children. Services include resources to support social~     emotional learning (SEL) and family engagement (FE) for all Pre-K for All (PKFA) programs and~     all PKFA families; Professional Learning to support the use of evidence-based SEL and FE~     practices for teachers and leaders from 350 PKFA programs; and ParentCorps programs for PKFA~     children and families in 50 PKFA programs (which is a subset of PKFA programs receiving~     Professional Learning). The current study evaluates the relative value of Thrive Professional~     Learning plus ParentCorps compared to Thrive Professional Learning.~      This study will include 158 pre-K teachers (teachers and teaching assistants) across 23~     Centers (12 Centers receiving Thrive Professional Learning plus ParentCorps, 11 Centers~     receiving Thrive Professional Learning only). All teachers in the 23 Centers will be invited~     to complete 2 self-report surveys over a two-year period. A sub-set of teachers will be~     randomly selected to participate in 2 interviews during this period. In addition, teachers in~     sites randomized to ParentCorps (12 Centers) will be invited to consent to the use of weekly~     implementation surveys, observational data and semi-structured interviews about experiences~     with implementation, collected as part of standard implementation practice of ParentCorps,~     for the purposes of this study.~   "
6319|NCT03484130|"~     This prospective cohort study will investigate the physiology and progression of autonomous~     aldosterone secretion.~   "
3273|NCT03524040|"~     The purpose of the study was to investigate if reflectance confocal microscopy (RCM) and~     optical coherence tomography (OCT) could be used in combination to investigate the morphology~     of pilosebaceous units and acne lesions in healthy subjects and in acne patients.Furthermore,~     to investigate contrast effects, biodistribution and selective photothermolysis provided by~     gold microparticles and diode laser pulses, using RCM, OCT and histology.~   "
3274|NCT03524027|"~     Congenital spinal deformities (CSD) are caused by early embryologic errors in vertebral~     column formation. Spinal cord malformations are present in approximately one third of~     patients, even associated cardiac, renal, and genitourinary organ system anomalies in more~     than half of patients. Functional activity and health-related quality of life (HRQOL) are~     severely affected in adolescents with neglected severe congenital kyphoscoliosis (CKS)~     progressive curves in developing countries.~      Different strategies are described with two main principles; I- Prophylactic surgeries like~     hemi-epiphysiodesis or in situ fusions that will cease worsening or allow progressive~     correction over time, II- Corrective surgeries like reconstructive osteotomies and spinal~     fusion with or without spinal resection. The perfect show in management of congenital spinal~     deformities is to pick up the curves at early stages where a prophylactic treatment can be~     achieved with minimal risk to the spinal cord, but certainly many cases are quite aggressive~     or come late enough where corrective surgeries and even spinal column resection is the only~     valid plan.~      A posterior-based vertebral column resection (VCR) is considered to be the preferred approach~     in the treatment of rigid, severe, and complex spinal deformities, however the difficult and~     lengthy nature of the procedure require assistance from experienced and well trained team. It~     is relatively safe but challenging technique, that allows for dramatic radiographic~     correction and clinical improvement. It also carries a complication rate of 10.2% as profound~     blood loss, iatrogenic neurological deficit and late junctional kyphosis.~   "
3275|NCT03524014|"~     The present research aims to collect virological and clinical data on hepatitis E virus (HEV)~     infections, either in acute or chronic forms of HEV infection in North-Eastern France, with~     liver- or non liver-related symptoms, plus data on HEV circulation in the outside~     environment. The purpose of this study is to improve the diagnosis and care of HEV-infected~     patients, as well as the preventive features to take into account in order to avoid food- and~     environment-borne infections. At last, we will investigate HEV molecular characteristics,~     with the hypothesis that some advantageous HEV strains coul be more pathogenic for some~     tissues and/or organs.~   "
3276|NCT03524001|"~     RATIONALE:~      Cardiac resynchronization therapy (CRT) is known to improve cardiac performance and to reduce~     morbidity and mortality in reduced-ejection fraction heart failure (HFrEF) despite optimal~     medical therapy (OMT). Several studies have shown that patients with with left bundle branch~     block (LBBB) respond favourably to CRT, whereas there is less certainty about non-LBBB~     morphology.~      Specifically, whether patients with right bundle branch block (RBBB) and HFrEF benefit from~     CRT is unclear. Some studies suggest lack of favourable outcomes. It follows from this that~     VVI implantable defibrillator are implanted in most RBBB patients.On the other hand right~     ventricular bifocal stimulation could be useful as an alternative approach in patient with~     RBBB. It consists of two endocardial leads implanted in right ventricle. The first lead is~     implanted in His bundle area, and the second lead is in the right ventricle apex. In this way~     bifocal pacing could decrease the inter- and intraventricular delays, thus improving left~     ventricular hemodynamics. However no specifically randomized studies are designed to date.~      PURPOSE:~      To demonstrate the superiority of right ventricular bifocal stimulation over placebo (VVI~     implantable defibrillator) in RBBB and HFrEF despite OMT.~      DESIGN Multicenter prospective randomized, double blind cross-over study. MASKING~     Investigator responsible for device programming is masked from having knowledge about~     clinical, functional, and echocardiographic data. On the other hand echocardiographist is~     masked from having knowledge about stimulation mode. Patients are masked from having~     knowledge about their clinical, functional, and device data.~      POPULATION At least fifty patients would be enrolled. The enrollment period should be one~     year. Study overall duration should be two years.~      ELIGIBILITY CRITERIA RBBB and HFrEF (left ventricular ejection fraction ≤35%) in sinus~     rhythm, in NYHA class II-III or ambulatory IV despite OMT.~      EXCLUSION CRITERIA~      -Refusal or withdrawal of informed consent.Renal failure (glomerular filtration rate ≤ 60~     ml/min).Life expectancy < 12 months.Active neoplasm.Permanent atrial fibrillation.40 days~     following acute coronary syndrome.Atrio-ventricular block (from second degree AV~     block).Valvular heart disease with surgery indications.~      PROTOCOL Each patient undergoes baseline assessment. Pharmacological therapy,~     hospitalization,NYHA functional class, QRS complex informations, type of heart disease and~     comorbidities are collected. Quality of life (QOL) is defined by Minnesota Living with Heart~     Failure questionnaire. Functional capacity is assessed by 6MWT (optionally by cardiopulmonary~     exercise test). Trans-thoracic echocardiogram is performed, analyzing: left-ventricle~     diameters and volumes, left-ventricle ejection fraction (LVEF), left atrial diameter and~     area, TAPSE,valvulopathy,systolic pulmonary artery pressure. All patients undergo bifocal~     right ventricular resynchronization therapy: right atrial lead is implanted, whereas the~     first ventricular lead is placed in His bundle area, and the second ventricular lead in the~     right ventricle apex. Then the leads are connected to the respective channels of a CRT-D~     generator.After the implant, all devices are programmed in VVI mode. After the first 40±10~     days (first f-up) patients are 1:1 randomized to VVI mode 40 beats/minute (placebo arm) or~     bifocal DDD-mode 60 beats/minute (with VV delay 0 msec and optimal AV delay). After six~     months (second f-up) a clinical and instrumental assessment equal to baseline is performed,~     as well as devices electrical parameters control. Then arms cross-over is performed (from~     VVI-mode to bifocal DDD-mode and vice versa). At 12 months (end of follow-up) an evaluation~     equal to that performed at 6 months is assessed. Echocardiographic data are unravelled to the~     investigator responsible for device programming. In this way the stimulation mode able to~     determine the best clinical improved (VVI or bifocal DDD mode) is programmed and the study~     closes.~      PRIMARY ENDPOINT The main assumption is that bifocal stimulation can increase of at least 20%~     the distance walked during 6MWT in respect of baseline and VVI-mode.The primary endpoint is~     the distance walked (expressed by meters) during 6MWT, as assessed at baseline, 6-months~     follow-up and 12 months follow up. Specifically changes in 6MWT observed during bifocal~     DDD-mode compared to baseline and to VVI mode would be significative if there is an increase~     of at least 20%.~      SECONDARY ENDPOINT~      Secondary endpoint is bifocal stimulation therapy response, defined by at least one of the~     following criteria, evaluated at baseline, 6-months follow-up and 12 months-follow-up in~     comparison to baseline and VVI mode:~      NYHA functional class improvement; changes in 6MWT, defined by an increase in distance walked~     major or equal to 30%; LVEF improvement major or equal to 25%;Left ventricular telesystolic~     volume reduction major or equal to 15%~   "
3277|NCT03523988|"~     This study is designed to determine if the preemptive use of a combination of acetaminophen~     and ibuprofen is more effective in reducing pain following orthodontic tooth movement when~     compared to the use of acetaminophen and ibuprofen alone. Before their orthodontic~     appointment, participants will be administered acetaminophen (650mg), ibuprofen (400mg), or~     acetaminophen (650mg) + ibuprofen (400mg). Participants will be asked to record their pain~     intensity using a numerical (0-10) visual analog scale (VAS) during rest, light biting, and~     while chewing paraffin wax during the following time intervals: immediately following drug~     administration, 6 hours after, the morning after, and the second morning after orthodontic~     treatment.~   "
3278|NCT03523975|"~     The purpose of this study is to determine if giving an experimental drug called venetoclax in~     combination with lenalidomide and rituximab is safe and effective for treating people with~     Mantle Cell Lymphoma (MCL).~   "
3279|NCT03523962|"~     The prevention of infection is an important goal influencing peri-operative care of extremity~     fracture patients. Standard practice in the operative management of extremity fractures~     includes sterile technique and pre-operative skin preparation with an antiseptic solution.~     The available solutions kill bacteria and decrease the quantity of native skin flora, thereby~     decreasing surgical site infection (SSI). While there is extensive guidance on specific~     procedures for prophylactic antibiotic use and standards for sterile technique, the evidence~     regarding the choice of antiseptic skin preparation solution is very limited for extremity~     fracture surgery.~   "
3280|NCT03523949|"~     The primary objectives of this study are to:~        -  Evaluate the ability of the older adults to understand the biological processes~          underneath a pain experience.~        -  Evaluate their ability to modify their behaviors and beliefs about pain and health.~   "
3281|NCT03523936|"~     Antibiotics disturb the balance of gut microbiota causing dysbiosis. The purpose of this~     double-blind placebo controlled intervention study is to investigate whether a new prebiotic~     product could prevent the side effects of antibiotics.~   "
3282|NCT03523923|"~     The purpose of this study is to (1) test the benefits of the patient-centered collaborative~     care treatment approach for persons who have had a TBI and who have pain, including headache;~     and also (2) test whether this approach improves quality of life, patient satisfaction,~     adherence to other treatments, and quality of care in the TBI care system.~      This project uses the contextual paradigm of disability to analyze and improve outpatient~     treatment of pain, including headache, in people who have had a TBI. Issues of restricted~     access and health care system complexity likely contribute to sub-optimal treatment of~     chronic pain. Therefore, the investigators seek to enhance real-world outpatient healthcare~     delivery through a patient-centered, collaborative care approach to treating chronic pain.~     The intervention is structured to reduce pain interference directly and indirectly through~     improved management of pain and comorbid conditions (e.g., depression, anxiety, and sleep~     difficulties) that can amplify pain perception and disability. In addition, change in the~     system of care may reduce burden on the emergency department. The investigators have heard~     from our clinician and patient partners that poor pain management often leads to emergency~     department visits, and this has also been reported in the literature.~   "
3283|NCT03523910|"~     The goals of this study were two-fold. First, the attempt to quantify the relationships~     between pulmonary arterial stiffness, right ventricular function and the efficiency of~     ventricular-vascular interactions in patients with pulmonary arterial hypertension (PAH).~     Second, the attempt to quantify the effects of exercise on pulmonary arterial stiffness,~     pulmonary vascular resistance, right ventricular function and the efficiency of~     ventricular-vascular interactions in patients with PAH.~   "
3341|NCT03523130|"~     The purpose of this study is to evaluate uptake of intravenously administered~     99mTc-tilmanocept using single photon emission computed tomography (SPECT/CT) scanning in~     individuals with HIV and individuals without HIV.~   "
3284|NCT03523897|"~     This study aims to see if outcomes for patients that receive the traditional total knee~     replacement surgical technique are different than the outcomes for patients that receive~     robot-assisted total knee replacement. The outcomes we will be tracking include:~        1. Patients' self-reported awareness of their artificial joints during activities of daily~          living;~        2. Patient's self-reported pain, other symptoms, function in daily living, function in~          sport and recreation, and knee-related quality of life;~        3. Patients' self-reported general health perceptions, physical functioning, role~          limitations due to physical and emotional problems, bodily pain, energy-fatigue, social~          functioning and mental health;~        4. The accuracy of implant placement and limb alignment~   "
3285|NCT03523884|"~     To assess if a technology-enabled Exercise program plus Education (TEEP + E) is more~     effective than Education program (EP) alone, in providing better outcomes (quality of life,~     at-work disability and productivity loss, firefighters' perception, adherence, overall~     improvement/deterioration) in firefighters with shoulder pain, at 3-, 6-and 12-month follow~     ups.~   "
3286|NCT03523871|"~     Patients who are Hepatitis C Negative (HCV negative) and are on the waiting list for a lung~     transplant at NYULH who consent to participate in this study will receive a lung transplant~     from a deceased donor that is HCV positive. Patients will initiate treatment for HCV with the~     pan-genotypic agent, Mavyret, on the day of surgery and will complete the full 8-week~     treatment course. Patients will be monitored post-transplant for the development of viremia,~     and for the time course of clearance of viremia among those who develop viremia.~   "
3287|NCT03523858|"~     This study is a prospective, multicenter, open-label, single-arm effectiveness and safety~     study in participants with progressive multiple sclerosis (PMS).~   "
3288|NCT03523845|"~     A case-control study was performed was performed following the STROBE statement from 1996 to~     2016 including patients who were diagnosed with early apical peri-implantitis. Data were~     collected at the time of implant placement, and once the patients developed signs and~     symptoms consistent with early apical peri-implantitis, to determine the frequency and~     etiology of this pathology.~   "
3289|NCT03523832|"~     Acute Pain is the most common early complication after total knee arthroplasty that caused~     delayed mobilization, demands of morphine, and higher operative cost. There were many~     researches that had been done in analgesia method to find the most effective analgesia,~     lowest side effect, and easy to apply. Preemptive analgesia of combined celecoxib and~     pregabalin were reported to give a promising outcome.~      In a randomized, double blind controlled clinical trial, 30 subjects underwent surgery for~     total knee arthroplasty using 15-20mg bupivacaine 5% epidural anesthesia. All subjects were~     divided into three groups. First group was given celecoxib 400mg and pregabaline 150mg 1 hour~     before operation, second group was given celecoxib 200mg and pregabaline 75mg twice daily~     started from 3 days before operation, and the last group was given placebo. The outcome was~     measured with VAS, knee ROM, and post-operative mobilization~   "
3290|NCT03523819|"~     This is a multicenter, open-label, multiple dose, dose escalation phase I study to evaluate~     the clinical safety, tolerability, PK, and preliminary anti-tumor efficacy of CS1002.~   "
3291|NCT03523806|"~     This three year study explores the feasibility and acceptability of conducting a full~     randomized controlled trial (RCT) of a promising coaching intervention for improving and~     sustaining physical activity (PA) and healthy dietary habits in children with physical~     disabilities (CWPD).~      Thirty children (ages 10 - 18) will spend 12 months in the study. All will receive usual care~     and basic printed information about healthy lifestyles. In addition, 15 will receive a~     coaching intervention for the first six months. Pre-defined success criteria will assess the~     feasibility of trial processes.~      Acceptability of trial participation and impact of coaching will be explored qualitatively.~     Health indicators and psychosocial outcomes will be assessed four times, at the start of the~     trial, immediately post-intervention and at three and six months post-intervention.~   "
3292|NCT03523793|"~     This study will investigate implementation of a process to enhance Clinical Practice~     Guideline (CPG) adherence to limit unwarranted variability in initial treatment decisions~     with high potential for providing more effective and efficient physical therapy management~     for patients with neck and low back pain.~   "
3293|NCT03523780|"~     The rate of postpartum hemorrhage (PPH) has risen dramatically in the developed world, along~     with a rise in blood transfusion rates. The rate of cesarean delivery has increased~     dramatically in the past decade and is well over 30% in the United States. With an increase~     in primary and repeat cesarean delivery, comes the added risk of abnormal placentation, which~     can contribute to maternal and fetal morbidity and mortality via placenta accreta, increta,~     and percreta. The incidence of accreta has increased 10-fold over the past 50 years, becoming~     the most common reason for cesarean hysterectomy in highly industrialized countries. These~     conditions have tremendous impact on maternal outcomes.~      Although whole blood (WB) contains all of the individual blood components, there are concerns~     for the use of WB due to the potential limitations such as the hemostatic efficacy of~     platelet after cold storage, the risk of hemolytic transfusion reaction following the~     transfusion of un-cross matched WB and the logistical issues in providing WB. Traditional~     obstetric transfusion protocols involve blood component therapy. Whole blood contains all~     components and could be more efficient for massive transfusion in obstetric hemorrhage.~     Trauma resuscitation protocols mimic whole blood in the 1:1:1 transfusion protocols of packed~     red blood cells to plasma to platelet ratio. It is difficult to compare trauma resuscitation~     to obstetric hemorrhage, but both can involve significant resuscitation and serious sequelae~     from unnecessary transfusion.~      The use of WB instead of component therapy may reduce the multiple organ dysfunction rates~     due to the rapid resolution of shock and coagulopathy. Additionally, the number of donor~     exposure is important factor for the transfusion-related allergic reactions including severe~     systemic reactions such as anaphylaxis. Use of WB may decrease number of donor exposure. The~     secondary aim is to compare the incidence of 3 common adverse outcomes associated with the~     transfusion of blood products in subjects who receive whole blood versus component therapy.~      We hypothesize that the patients receiving WB will have fewer incidences of a) acute renal~     failure, b) acute heart failure and c) transfusion-related lung disease compared to those~     receiving component therapy.~   "
3294|NCT03523767|"~     The purpose of this pilot study is to investigate and compare the effect of a mild~     inflammatory stimulus (typhoid vaccine) on immune response, mood and cognition in healthy~     volunteers compared to patients with history Major Depressive Disorder (MDD) (not currently~     depressed and no symptoms of depression in the past 6 months).~   "
3295|NCT03523754|"~     Evaluation of safety & efficacy of nitric oxide donors such as intravaginal isosorbide~     mononitrate in addition to misoprostol Versus misoprostol only for the whole process of~     induction of labor.~   "
3296|NCT03523741|"~     The purpose of this study is to evaluate the factors affecting the occurrence of adverse drug~     reactions (glucose and lipid metabolism abnormality, changes in liver function index and~     sleeping tendency) and clinical effects in schizophrenia patients with clozapine treatment~   "
3297|NCT03523728|"~     Primary Objective:~      To determine the effect of GZ/SAR402671 on the rate of total kidney volume (TKV) growth and~     eGFR in patients at risk of rapidly progressive Autosomal Dominant Polycystic Kidney Disease~     (ADPKD).~      Secondary Objectives:~        -  To determine the effect of GZ/SAR402671 on the rate of renal function decline (Stage 1)~          and on the rate of TKV growth (Stage 2).~        -  To evaluate the pharmacokinetics (PK) of GZ/SAR402671 in ADPKD patients (Stages 1 and~          2).~        -  Safety/tolerability objectives:~             -  To characterize the safety profile of GZ/SAR402671 (Stages 1 and 2).~             -  To evaluate the effect of GZ/SAR402671 on mood using Beck Depression Inventory II~               (BDI-II) (Stages 1 and 2).~             -  To evaluate the effect of GZ/SAR402671 on the lens by ophthalmological examination~               (Stages 1 and 2).~             -  To evaluate change in nocturia based on patient reported diary (Stages 1 and 2).~             -  To evaluate the effect of GZ/SAR402671 on kidney concentrating ability by assessing~               urine osmolality (in patients not on diuretic) (Stage 2 only).~   "
3298|NCT03523715|"~     This is a prospective, randomized control trial that randomizes patients post-operatively~     into standard care versus standard care plus prunes. Patients in the control arm will take~     100 mg docusate twice per day for 3 days (standard care). Participants in the treatment arm~     will consume 4 oz prunes daily and take 100 mg docusate twice per day for 3 days. The primary~     objective is to determine the time to first bowel movement after surgery.~   "
3299|NCT03523702|"~     The goal of this study is to explore if, for locally advanced non-small cell lung cancer~     patients whose tumors have high levels of PD-L1 (a marker associated with benefits from~     immunotherapy), a combination of immunotherapy and a personalized 4-week radiotherapy course~     could be more effective than standard treatment, which is a combination of chemotherapy and~     radiotherapy.~   "
3300|NCT03523689|"~     The goal of this clinical research study is to learn if and how often a standard procedure~     called endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) may cause~     atelectasis. Atelectasis is the complete or partial collapse of the lung which may cause~     difficulty breathing.~      This is an investigational study. EBUS-TBNA is performed using FDA-approved and commercially~     available methods.~      The EBUS-TBNA procedures will be performed as part of participant's standard of care.~      Up to 57 participants will be enrolled on this study. All participants will take part at MD~     Anderson.~   "
3301|NCT03523676|"~     Red cell distribution width variations are increased in a variety of medical conditions such~     as congestive heart failure, acute myocardial infarction, pulmonary embolism, pneumonia,~     critical illness, and cardiac arrest , and is a predictor of mortality in the general~     population..~   "
3302|NCT03523663|"~     The goal of this study is to create a formal, quantitative methodology to determine what is~     the most beneficial dose of Central Nervous System (CNS) stimulant (Ritalin, methylphenidate)~     to improve cognitive and behavioral function of children diagnosed with Attention Deficit~     Hyperactivity Disorder (ADHD) individually. If successful, it will change the way in which~     the dose of CNS stimulant for treating ADHD is determined for children in need of therapeutic~     intervention. The project will be focused on developing the necessary methodology to analyze~     the children's data with the drift-decision model (DDM), and to develop the required~     technology, i.e., a computer game with which to measure cognitive/behavioral function and its~     validation with eye-tracking measurements.~   "
3303|NCT03523650|"~     The purpose of this study is to evaluate the role of propranolol as an alternative treatment~     for cavernous malformation in patients that may not be ideal candidates for surgery.~   "
3304|NCT03523637|"~     The aim of this study is to investigate the use of Interoceptive Exposure (IE) in treatment~     of disabling fear of pain using a single-case series design.~   "
3305|NCT03523624|"~     In medical practice, a combination of clinical exam, electrocardiograms, circulating~     biomarkers, and imaging is used to gain insights on the prognosis after myocardial~     infarction. Novel molecular non-invasive tools are needed that help clinicians overcome the~     adverse events of post-myocardial infarction remodelling and thereby achieve improved therapy~     for its prevention.~      Coagulation factor XIII (FXIII) decay has been linked to major adverse cardiac events (MACE)~     in patients with acute coronary syndromes. Given the correlation between both intramyocardial~     haemorrhage and microvascular damage with acute phase complications in ST-elevation~     myocardial infarction, we hypothesise that excessive FXIII decay within the first week may~     predict acute phase outcomes in these patients. If this holds true, FXIII determination could~     be used as diagnostic and prognostic tool.~   "
3306|NCT03523611|"~     The purpose of this study is explore the impact of lung cancer surgery on inflammation and~     function of the right side of the heart.~   "
3307|NCT03523598|"~     This study will determine the effectiveness of the use of desensitivity gels prior in office~     bleaching on risk and intensity of tooth sensitivity caused by in-office bleaching using 35%~     hydrogen peroxide and using different types of potassium nitrate. Materials and Methods:~     Seventy five patients will be selected for this triple-blind, randomized, cross-over,~     placebo-controlled clinical trial. 10 minutes prior to bleaching procedure, patients will~     receive the the potassium nitrate 2% or placebo gel application on vestibular surface and~     Toothpaste 15 days before start the bleaching procedure (group 1: placebo gel + Colgate~     toothpaste; Group 2: Placebo gel + Nitrate toothpaste Sensodyne and Group 3: Potassium~     Nitrate + Colgate toothpaste). The whitening treatment with 35% hydrogen peroxide will be~     carried out in two sessions with a 7-day interval.~      Tooth sensitivity will be assessed before, during and 24 hours after the procedure using~     analog visual and verbal scales. Color alteration will be assessed by a Vita Guide scale at~     the end of the last session. Relative risk to sensitivity will be calculated and adjusted by~     session; while comparison of overall risk will performed by McNemar's test. Data on the~     sensitivity level and color shade will be subjected to the Friedman, Wilcoxon (α = 0.05). If~     necessary, multiple comparation will be done using Tukey's test.~   "
3308|NCT03523585|"~     The study is designed to compare DS 8201a versus standard of care (investigator's choice) in~     subjects with unresectable and/or metastatic breast cancer previously treated with T DM1.~   "
3342|NCT03523117|"~     The primary objective of this study is to demonstrate the efficacy and safety of intravenous~     ferric carboxymaltose (FCM), compared to oral iron, in pediatric participants who have iron~     deficiency anemia.~   "
6480|NCT03482011|"~     The purpose of this study is to evaluate the efficacy and safety of mirikizumab in~     participants with moderate to severe plaque psoriasis.~   "
3309|NCT03523572|"~     The purpose of this phase 1b study is to test the combination of an experimental drug known~     as DS-8201a given along with Nivolumab (a marketed drug) in participants with HER2-expressing~     breast and urothelial cancer who had disease progression during or after prior therapies, did~     not respond to standard therapies, or for whom no standard therapy is available.~      The study will be performed in 2 parts.~        -  Part 1 is to look at different doses of DS-8201a when given along with a fixed dose of~          nivolumab, and establish the most effective and safe dose (maximum/recommended tolerated~          dose) when used in combination with nivolumab.~        -  Part 2 is to understand the positive or negative effects of this dose combination on the~          participant's body and disease.~      The study will also determine the pharmacokinetics of DS-8201a when administered with~     nivolumab.~   "
3310|NCT03523559|"~     Genetic and Histopathologic Characteristics of Interstitial Cystitis~   "
3311|NCT03523546|"~     The Oncology Episode Payment Model (EPM) is a payment model designed to test the effects of~     better care coordination on health outcomes and costs of care for Hawaii Medical Services~     Association (HMSA) members with cancer who receive chemotherapy.~   "
3312|NCT03523533|"~     This is an observational study intended to characterize the time-to-placement of~     peripherally-inserted internal jugular (PIJ) catheters in appropriate patients. As secondary~     outcomes and to ensure patient safety, the investigators will record and evaluate adverse~     outcomes, but the study is not powered to detect rare events.~   "
3313|NCT03523520|"~     The purpose of this study is to compare the efficacy of subcutaneous versus oral mu-opioid~     receptor antagonist therapy in opioid induced constipation that is refractory to other bowel~     regimens.~   "
3314|NCT03523507|"~     This study aims to investigate the efficacy and tolerability of fMRI-targeted repetitive~     transcranial magnetic stimulation (rTMS) in the treatment of depressive symptoms in service~     members with a history of concussive traumatic brain injury (TBI).~      Up to ninety participants will be randomized to active or sham treatment. Participants~     randomized into the active group will receive 20 sessions of left-sided dorsolateral~     prefrontal cortex (DLFPC) high-frequency rTMS, followed by right-sided DLFPC low-frequency~     rTMS. The DLPFC treatment area will be identified by using individual subject-level resting~     state network estimation (Hacker et al., 2013). Participants randomized into the sham~     treatment group will receive 20 sham treatments designed to have similar sound and tactile~     sensation, without producing active treatment. Participants will also be asked to complete~     regular follow-up evaluations for up to a total of six follow-up sessions. Those who do not~     respond to the treatment will have the option to receive active treatment through this study~     regardless of group assignment to active or sham.~   "
3315|NCT03523494|"~     Development of lympho-proliferation reticulation quantification using CT.~   "
3316|NCT03523481|"~     Patients with AECOPD and NIV failure and in absence will be treated with NHF device.~     Inclusion criteria are pH < 7,38 and pCO2 > 45 mm Hg. Patients were treated if pH >7,38 or~     refusal of therapy.~   "
3317|NCT03523468|"~     In surgical treatment decisions, locally advanced central lung cancer is the most difficult.~     When infiltrating into the trachea, conventional pneumonectomy cannot achieve the purpose of~     radical treatment.Pulmonary sleeve resection involves the removal of part of the main~     bronchus and can completely remove the tumor, as far as possible to retain normal lung~     function, fully embodies the surgical principle and is worthy of clinical promotion.this~     study intends to compare uniportal-sleeve and open-chest sleeve lobectomy for the treatment~     of central lung cancer, analyzing the curative effect and quality of life of postoperative~     patients on the basis of previous accumulation.~   "
3318|NCT03523455|"~     Participants are required to undergo a screening and qualification before beginning the~     study. Once qualified, baseline testing is completed in the laboratory. This testing~     includes: body composition measurements, a blood draw, questionnaires, a VO2 max test, and a~     time to exhaustion trial. This testing is repeated during week 4 and week 12. At week 8,~     subjects complete a blood draw and questionnaires only. During the 12 week period,~     participants will follow an endurance exercise program in which they will train 4 days per~     week. This is a double-blind study in which participants are randomized into either the~     placebo or supplement group. They are instructed to ingest the supplement once a day at~     breakfast. Diet logs are also monitored throughout the duration of the study with the~     restriction of no red meat.~   "
3319|NCT03523442|"~     The purpose of this study is to evaluate pharmacokinetics (PK) following a single dose and~     multiple dose treatment and the safety of apalutamide in Chinese participants with metastatic~     castration resistant prostate cancer (mCRPC) at dose of 240 milligram (mg).~   "
3320|NCT03523429|"~     The PETHEMA Spanish group treats patients with high-risk Philadelphia chromosome-negative~     ALL, aged 18 to 55 years, based on the MRD clearance as assessed by flow cytometry at a~     centralised evaluation centre. Patients with MRD < 0.1% (< 1×10-3) after induction and <~     0.01% (< 1×10-4) after early consolidation are assigned to receive chemotherapy (late~     consolidation and maintenance).~      Early consolidation chemotherapy consists of three cycles including high doses of MTX, ARA-C~     and ASP, together with vincristine and dexamethasone. The same therapy is repeated in the~     late consolidation period if MRD after early consolidation is < 0.01% (< 1×10-4). Maintenance~     therapy is then administered for up to 2 years from the CR date. These patients do not~     receive allo-HSCT if they maintain adequate MRD clearance.~      Despite having adequate MRD clearance, a proportion of patients (around 25%) experience~     relapse, which makes other approaches necessary to try to decrease the relapse rate.~     Intensifying currently existing chemotherapy regimens is not likely to increase the cure rate~     and would likely significantly increase toxicity. The use of targeted immunotherapeutic~     agents such as blinatumomab, which has demonstrated efficacy and safety in patients with R/R~     ALL and in patients with ALL and MRD+, seems to be a promising option [30-33].~      Therefore, it would be interesting to assess the potential efficacy of using blinatumomab in~     CR patients to reduce the MRD more frequently and more intensely during the early and late~     consolidation period. Our hypothesis is that blinatumomab will further reduce the level of~     MRD and this could lead to a decrease in the relapse rate in these patients.~      This trial will replace the third early consolidation cycle with a cycle of blinatumomab, and~     the same will be done in the late consolidation period. We hope that this strategy will~     increase the extent of the MRD response and prevent relapses.~      Moreover, and as a secondary objective, we will investigate the safety of blinatumomab~     administration after the administration of high-dose chemotherapy including MTX, ARA-C and~     ASP~   "
3343|NCT03523104|"~     The purpose of the Chinese PD-LRRK2 Registry(CPD-LRRK2R) is to develop a database of patients~     of Parkinson's disease with leucine-rich repeat kinase 2 (LRRK2) gene variants in mainland~     China.~   "
3344|NCT03523091|"~     Patients with overactive bladder (OAB) will be randomly assigned (like a flip of a coin) to~     receive 100 units of onabotulinumtoxinA injected into the bladder at either 3 sites or 10~     sites. Patient satisfaction and the effectiveness of the medication will be evaluated.~   "
3345|NCT03523078|"~     This study aim to investigate the breast reconstruction outcome after mastectomy with or~     without radiation therapy from the patient's point of view.~   "
3321|NCT03523403|"~     Obesity is characterized by an underlying inflammatory state in which various inflammatory~     signaling molecules, termed cytokines, affect metabolic processes central to type 2 diabetes~     and cardiovascular disease; leading causes of disability and death in Ontario. Such~     obesity-associated inflammation is partly due to the movement of endotoxin (i.e.~     lipopolysaccharide (LPS), a cell wall component of Gram-negative bacteria) from the gut~     microbiota to the blood, resulting in elevated blood levels of LPS (a condition termed~     metabolic endotoxemia) that stimulates inflammation. Digestion of a high-fat meal increases~     blood LPS and is subsequently associated with inflammation and metabolic impairments.~     However, in this context, little is known about how the consumption of bioactive-rich foods,~     such as whole apples, can improve impaired inflammatory and metabolic responses in overweight~     and obese individuals. Apples are a key commodity to study given that they are Ontario's~     predominant fruit crop with the apple industry valued at approximately $400 million, they~     require little food preparation, and they are common in the diet year-round. There are some,~     but limited, reports of potential apple-induced health benefits related to reductions in~     inflammation and improved metabolic responses in lean/healthy individuals, but work in~     overweight and obese individuals is especially lacking. Thus, to address the gap in our~     understanding of how daily apple intake may improve the health consequences of obesity, we~     will conduct a randomized clinical trial in which overweight and obese adults will consume~     three Ontario-grown Gala apples (approximately 300 g) as part of their typical diet in one~     sitting (i.e. acute consumption) and/or daily for six weeks (i.e. chronic consumption). The~     Acute Apple Consumption phase of the study will follow a randomized crossover design in which~     participants' rate of gastric emptying, efficacy of dietary lipid digestion and absorption,~     and production of inflammatory cytokines and biomarkers of metabolism will be assessed before~     and after consuming a high-fat meal (designed to provide 1 g fat/kg body weight) with or~     without three apples in one sitting. The Chronic Apple Consumption phase of the study will~     follow a randomized, controlled, parallel-arm design in which participants' (fasting)~     production of inflammatory cytokines and biomarkers of metabolism, as well as their gut~     microbiota profile, will be assessed before and after consuming three apples (or no apples)~     daily for six weeks. We hypothesize that the consumption of three whole apples in one sitting~     and daily for six weeks will improve these parameters in overweight and obese individuals at~     risk of developing chronic metabolic diseases.~   "
3322|NCT03523390|"~     The purpose of this study is to evaluate the maximum tolerated dose (MTD) and~     pharmacokinetics (PK) of Avelumab monotherapy in Chinese subjects.~   "
3323|NCT03523377|"~     The purpose of this study is to test whether regular not eating for at least 12 hours~     (overnight fasting) can improve blood sugar and the health of the GI tract.~      There are 2 parts to this study: Part 1 will last for 1-2 weeks and will determine whether~     the patient can participate in Part 2. If they complete Part 1 they are eligible to~     participate in Part 2, they will sign a separate consent form for Part 2. Part 2 of this~     study will last 6 months.~   "
3324|NCT03523364|"~     This study evaluates retrospectively the survival rate of all-ceramic restorations, cemented~     using AWB technique (test) compared to those cemented with conventional technique (control)~   "
3325|NCT03523351|"~     The purpose of the study is to compare the outcome of patients who receive standard treatment~     versus those who receive preventative radiation and then standard treatment.~   "
3326|NCT03523338|"~     The purpose of this study is to collect additional safety data until apalutamide is~     commercially available for participants with non-metastatic castrate-resistant prostate~     cancer (NM-CRPC).~   "
3327|NCT03523325|"~     This study will evaluate if there is a difference in recovery of tendon structure and~     mechanical properties between males and females with Achilles tendinopathy receiving exercise~     treatment. It will evaluate recovery of tendinopathy with exercise intervention using outcome~     measures for tendon structure and mechanical properties along with validated measures of~     muscle-tendon function and symptoms.~   "
3328|NCT03523312|"~     This study is being done to test whether receiving a dose of radiation that is higher than~     the standard dose, in combination with chemotherapy, improves the chance of becoming a~     candidate for surgery and improves the chance of extending the patient's life.~   "
3329|NCT03523299|"~     This study will investigate the safety, feasibility, and immune response associated with~     cryoablation of early invasive breast cancer prior to lumpectomy. Based on mouse models, the~     investigators believe that cryoablation will initiate a stronger immune response relative to~     the control group.~      Consenting patients will be randomized to one of two arms: standard of care (control) or~     cryoablation (intervention). Participants will undergo a blood draw at the time of consent.~     Those in the control arm will continue with their standard of care lumpectomy. The~     intervention arm will receive cryoablation 2 weeks before their scheduled lumpectomy and~     undergo a second blood draw before the lumpectomy.~   "
3330|NCT03523286|"~     RAPID-VT Pilot is a single centre prospective cohort pilot study to assess the feasibility,~     safety and efficacy of catheter ablation of ventricular tachycardia (VT) guided by a novel~     real-time software to localize the origin of VT during the ablation procedure.~   "
3331|NCT03523273|"~     This study is being done to assess the stomach emptying effect of a maximum dose of 3 mg~     Liraglutide compared to placebo in subjects who are overweight or obese. Liraglutide is a~     medication approved by the Food and Drug Administration (FDA) for routine clinical use.~   "
3332|NCT03523260|"~     The patient population for this study is individuals requiring high-flow polyurethane~     tunneled dialysis catheters (TDC) for hemodialysis access. The primary objective of this~     study is to compare outcomes of participants who undergo left internal jugular placement of a~     split-tip versus a step-tip versus symmetric tip catheter. This study will review and compare~     the complication rate and function of the three catheter designs.~   "
3333|NCT03523247|"~     This study seeks to determine the effects of a whole-food, plant-based diet on lipid,~     metabolic, and inflammatory biomarkers. Eligible participants will have had either an LDL-C >~     200 mg/dL or non-HDL-C > 130 mg/dL without a current diagnosis of coronary heart disease and~     are willing to adhere to a whole food plant based diet for at least 8 weeks. Participants~     enrolled in the study will provide fasting blood work, complete a baseline quality of life~     survey, and receive education on a whole-food, plant-based diet at a local Lancaster County~     grocery store during their first study visit. Throughout the study, patients will have access~     to dietary counseling which will be provided by a certified nutritionist and will be asked to~     record and submit daily food diaries. Study participants will be asked to adhere to a whole~     food plant based diet for a total of 8 weeks. Prior to the final study visit, participants~     will be asked to obtain follow-up fasting bloodwork around 7 weeks post start of whole food~     plant based diet. The results, along with a follow-up quality of life survey, and an~     opportunity to discuss the bloodwork with a doctor will be held at the local grocery story 8~     weeks after the first study visit.~   "
3346|NCT03523065|"~     The purpose of the Chinese Parkinson's disease with GBA variants Registry (CPD-GBAR) is to~     develop a database of patients of Parkinson's disease with Glucocerebrosidase (GBA) gene~     variants in mainland China.~   "
3347|NCT03523052|"~     The purpose of the Chinese PD-SNCA Registry(CPD-SNCAR) is to develop a database of patients~     of Parkinson's disease with a-synuclein (SNCA) gene variants in mainland China.~   "
3334|NCT03523234|"~     The main purpose of this study is to compare the effects of neoadjuvant with radical surgery~     on the prognosis of patients with stage II and IIIA small cell lung cancer (SCLC). The~     primary endpoint of this study is to observe 5-year survival, disease-free survival (DFS),~     and overall survival (OS) in patients. Secondary efficacy indicators include recurrence rate,~     surgical complications, resection rate, quality of life (QoL), and exploration biomarker~     (tumor tissue).~      This is a two-arm, open, multicentral clinical study designed to assess the disease-free~     survival (DFS) and overall survival (OS) of neoadjuvant chemotherapy plus radical surgery for~     stage II and IIIA small cell lung cancer (SCLC). About 300 patients will be enrolled in the~     study and randomly divided into two groups of 150 individuals. The neoadjuvant with radical~     surgery group received 2 to 4 cycles of neoadjuvant treatment with etoposide plus~     cisplatin/carboplatin before receiving radical surgery, followed by 2 to 4 cycles of adjuvant~     chemotherapy (etoposide with cisplatin/carboplatin) plus radiotherapy. Patients in the~     control group are planned to receive 4 to 6 courses of etoposide plus cisplatin/carboplatin~     for chemotherapy and radiotherapy.~   "
3335|NCT03523221|"~     Anaphylaxis is an acute serious allergic reaction, with multi-organ system manifestations~     caused by the release of chemical mediators and it is potentially fatal [1, 2].~      Between 5% and 14% of patients may experience a recurrence of anaphylaxis 8-12 hours after~     the initial presentation, called biphasic (late-phase) [14].~      The mainstay of treatment for children experiencing anaphylaxis remains adrenaline and~     H1-antihistamines. Corticosteroids are not life-saving and do not have an immediate effect on~     the symptoms of anaphylaxis but may help reduce or prevent a biphasic late phase reaction~     (24.26).~      The aim of this study is to compare the efficacy of oral glucocorticoids in prevention of the~     second phase or biphasic reaction of anaphylaxis, as compared to placebo in children,~     presenting to the pediatric emergency department (PEC Al-Sadd) with mild to moderate~     anaphylaxis (Prospective Study).~      Patients will be randomized to either one of the two treatment:~      Treatment 1: Dexamethasone 0.6mg/kg oral. Treatment 2 : Placebo All patients will be urgently~     treated for anaphylaxis according to guideline protocol. Enrolled patients will be given one~     of the study medications orally, and he /she will observe in the observation room with~     cardiac monitor and close monitoring by nurse.~      The treating physician will discharge patient when he/she looks well, breathing comfortably,~     has oxygen saturation >94%, stable blood pressure and no gastrointestinal or neurological~     manifestation.~      Discharge patients will be sent home on anti-histamine (cetirizine) for 5days. All patients~     will be followed up for one week post discharge by a phone call asking about the general~     condition, relapse of symptoms, or need for readmission.~   "
3336|NCT03523195|"~     This pilot trial studies how well exercise intervention after cancer treatment works in~     improving physical activity in stage II-III breast cancer survivors. An exercise intervention~     may promote regular physical activity.~   "
3337|NCT03523182|"~     Background: In developing countries, micronutrient deficiency in infants is associated with~     growth faltering, morbidity, and delayed motor development. One of the potentially low-cost~     and sustainable solutions is to use locally producible food for the home fortification of~     complementary foods.~      Objective: The objectives are to test the hypothesis that locally producible spirulina~     platensis supplementation would achieve the following: 1) increase infant physical growth; 2)~     reduce morbidity; and 3) improve motor development.~      Design: 501 Zambian infants are randomly assigned into a control (CON) group or a spirulina~     (SP) group. Children in the CON group (n=250) receive a soya-maize-based porridge for 12~     months, whereas those in the SP group (n=251) receive the same food but with the addition of~     spirulina. The change in infants' anthropometric status, morbidity, and motor development~     over 12 months are assessed.~   "
3338|NCT03523169|"~     Sepsis related cerebral dysfunction was underestimated in critical illness setting, and~     inflammatory response of brain could not be monitored directly and cerebral oximetry offered~     information of cerebral dysfunction. We had hypothesized cerebral oxygenation responsiveness~     during passive leg raising could in some way had association in predicting with the outcomes~     of septic shock.~   "
3339|NCT03523156|"~     The study population consists of all households residing in eligible kebeles (sub-districts)~     within districts in Amhara National Regional State which are identified as having a high~     prevalence of trachoma and infection measured from recent trachoma impact assessments. Within~     each study kebele, one village will be randomly selected to serve as the sentinel study site~     for that kebele. Once these villages are chosen, the study team will use government-provided~     census records, or perform a census in each village, and will randomly choose 50 children to~     serve as the sentinel children for the study. After the baseline visit, all kebeles will be~     randomized into one of the two treatment arms to either receive standard-or-care treatment,~     which is an annual community-wide mass drug administration (MDA), or the enhanced antibiotic~     treatment. Recruitment will take place at the selected children's household. Oral informed~     consent will be sought from village leader/chairmen before surveys are conducted in a~     village. Oral informed consent will then be obtained from household heads of those houses~     included in the study; and then from each participating individual. Oral consents will be~     obtained given the low literacy rates in rural Amhara.~      Data collection will occur at baseline, week 4, month 12, and month 24 in both arms of the~     study. A head of household will be asked a series of household level questions, which will be~     followed by a household-level census, where all consenting participants residing in the~     selected households will have their eyes examined for trachoma signs. This is a non-invasive~     procedure whereby a trained trachoma grader flips each eyelid and examines for trachoma~     signs. Lastly, the selected child and one randomly selected adult will have their right eye~     lid swabbed for evidence of trachoma infection. The total estimated respondent burden is 30~     to 45 minutes.~   "
3340|NCT03523143|"~     Context: Women with gestational diabetes have excessive fetus growth weeks earlier than the~     screening period recommended currently, suggesting that earlier screening and intervention~     may improve pregnancy outcomes and the health of the offspring.~      Objective: To determine if early screening and intervention could alter pregnancy outcomes,~     the incidence of maternal diabetes after delivery, and growth and development of the~     offspring, compared to the standard group.~      Design, Setting, Participants: We will conduct an open-label randomized controlled trial in~     2068 pregnant women, who deliver a singleton and who have not been diagnosed with overt~     diabetes mellitus at National Taiwan University Hospital from 2018 to 2020.~      Interventions: Gestational diabetes mellitus (GDM) is diagnosed by a 75g 2-hour OGTT at 18-22~     weeks of GA for the early-screening group and at 24-28 weeks for the standard-screening~     group. The diagnostic cutoffs are according to the IADPSG criteria. GDM is diagnosed if one~     of the plasma glucose levels at fasting, 1-hour, and 2-hour during OGTT is above 92 mg/dL,~     180 mg/dL, or 153 mg/dL respectively. Subjects who are diagnosed with GDM receive lifestyle~     intervention and self-monitoring of blood glucose. Pharmacological therapies are given when~     the target of glycemic control is not achieved within 4-6 weeks.~      Main Outcome Measure: The primary outcome is a composite measure of pregnancy outcomes,~     including primary CS, birth weight >90th percentile, neonatal hypoglycemia, cord serum~     C-peptide >90th percentile, pregnancy-induced hypertension, preeclampsia and birth trauma.~     The primary outcome is measured within the entire period of perinatal and neonatal~     intensive-care units (NICU) stay for infants and the entire period of gestation for pregnant~     women after randomization.~      Conclusion: This study will test our hypothesis that early screening and intervention of GDM~     improves pregnancy outcomes as compared to standard practice.~   "
6481|NCT03481998|"~     The Study is aimed to evaluate the safety SHR6390 plus Letrozole and to assess the effect of~     the combination on Advanced Breast Cancer~   "
3349|NCT03523026|"~     The aim of this study is to investigate the effects of peripheral and respiratory muscle~     training on respiratory muscle strength, respiratory functions, exercise capacity and quality~     of life in coronary artery patients with metabolic syndrome. Prospectively, randomly,~     double-blind, and controlled study. Stable coronary artery patients with metabolic syndrome~     will be included to the study from the Istanbul University Cardiology Institute clinic.~     Patients will be randomized into 3 groups; Neuromuscular Electrical Stimulation (NMES) and~     Peripheral Muscle Training Group (n: 20): 3 days per week for 6 weeks duration. Peripheral~     Muscle Training will be applied by elastic band and Proprioceptive Neuromuscular Facilitation~     three times per week for 6 weeks.Inspirator Muscle Training (IMT) and peripheral muscle~     training Group (n: 20): IMT will be applied 7 days per week, twice a day for 15 minutes. The~     program will continue for 6 weeks duration under weekly control of the investigator. Training~     intensity will set at 30% of the maximum inspiratory pressure.Peripheral Muscle Training will~     be applied by elastic band and Proprioceptive Neuromuscular Facilitation three times per week~     for 6 weeks. Peripheral Muscle Training Group (n: 20): Exercise will be applied by elastic~     band and Proprioceptive Neuromuscular Facilitation three times per week for 6~     weeks.Parameters will be recorded before and after training. Evaluation~     parameters:Demographic and anthropometric measurements, respiratory function test,respiratory~     muscle strength,dyspnea, peripheral muscle strength, 6 minutes walking test, physical~     activity, quality of life, depression, sleep quality and laboratory evaluation.~   "
3350|NCT03523013|"~     The outcome of CPAP titration under sleep endoscopy: A randomized controlled crossover trial~   "
3351|NCT03523000|"~     The purpose of this study will be to determine the efficacy and the prognostic value of a~     continuous intrathecal prognostic infusion test in an in-hospital setting for selecting~     patients who would have better long term outcomes for treatment with intrathecal implantable~     devices. The investigators will compare the primary outcomes [changes in pain intensity score~     (NRS), patient global impression of change (PGIC)] before and after intrathecal infusion of~     an admixture of bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml versus normal saline.~      The study will include 36 patients with intractable chronic low back pain in the setting of~     lumbar post-laminectomy syndrome or vertebral compression fracture who failed conservative~     management and are considered candidates for IDDS.~      Prior to the implant, the patients will undergo an intrathecal prognostic infusion test with~     an externalized catheter. Baseline NRS pain scores will be assessed and documented on all~     patients upon admission to the preoperative area. An intrathecal catheter will be placed in~     the outpatient procedure suite at the appropriate level for target dermatomes. The needle~     entry point will occur in the upper lumbar spine and catheter tip will be placed in the lower~     thoracic spine, under local anesthesia with the patient awake and with minimal or no~     sedation. The intrathecal infusion will be started using an external pump once patient is in~     the PACU. The research component is to perform the intrathecal test with normal saline~     (inactive placebo solution) in addition to a test with fentanyl and bupivacaine (active~     solution). Patients will be randomly assigned to either Group I (continuous infusion of~     bupivacaine and fentanyl followed by saline) or Group II (continuous infusion of saline~     followed by bupivacaine and fentanyl).~      In PACU, patients will be started on an infusion rate of 0.5 ml/hr and titrated to pain~     relief greater than 50% of baseline or up to 0.8-1.0 ml/hr within 6-8 hrs after start of the~     infusion. A clinician blinded to the treatment arm will assess NRS and PGIC on the patients~     after approximately 12 hours. Assessment will include changes in pain intensity score at rest~     and upon ambulating or performing maneuvers that normally elicit patient's low back pain. A~     4-6-hour washout period will be allotted with infusion of preservative-free normal saline at~     a rate of 0.2 ml/hr, after which the physician will document a return of the NRS to baseline~     before switching therapies.~   "
3352|NCT03522987|"~     As a potential solution to address high rates of depression and anxiety seen in epilepsy~     patients and poor mental health care access, this trial aims to carry out treatment for~     depression and anxiety directly in the epilepsy clinic. Patients that meet eligibility~     criteria, including significant symptoms of depression and/or anxiety, will be enrolled in~     the intervention. The intervention will consist of an initial prescription for an~     FDA-approved medication to treat depression/anxiety and telephone-based chronic care~     management plan for repeated symptom measurement and side effect surveillance. The purpose of~     this pre-piloting limited study is to streamline recruitment, intervention and outcome~     assessment process in preparation for a randomized, controlled pilot of the intervention.~   "
3353|NCT03522974|"~     Dietary interventions designed to promote health by increasing the consumption of particular~     health-promoting foods (e.g., strawberries) generally target blood pressure and LDL-C;~     however, CVD risk reduction may also be achieved via changes in emerging endpoints such as~     the gut microbiome. Previous research suggests that strawberries have the potential to reduce~     LDL-C, but it remains unclear whether there is a dose-response relationship. Moreover, few~     studies have evaluated effects on vascular health or characterized changes in the gut~     microbiome following daily strawberry consumption. Additionally, previous studies have~     largely been conducted among Caucasian populations. Given the demographics of the US, it is~     important to evaluate effects in study populations that include ethnicities that may have~     higher risk of type 2 diabetes and/or other CVD risk factors, such as Hispanics. This study~     aims to examine the effects of 4 weeks of supplementation with two doses of freeze dried~     strawberry powder (low dose: 13 g/d and high dose: 40 g/d) on: 1) LDL-C and blood pressure;~     2) gut microbiome profile; and 3) other CVD and type 2 diabetes risk factors, including~     glucose, insulin, and inflammatory markers. Overweight (BMI 25-36 kg/m2) but otherwise~     healthy adults with moderately elevated LDL-C (>3.0 mmol/L) and/or prehypertension~     (120-159/80-99 mm Hg) will be enrolled. This will optimize the potential for observing~     significant benefits on these outcomes. 50 eligible participants will be recruited with the~     expectation that at least 40 will complete the study. The placebo-controlled, crossover study~     design will allow for a direct comparison of dose-response within the same participant. The~     investigators anticipate that the bioactive components of strawberries will reduce LDL-C and~     blood pressure, and modify the gut microbiome, with greater changes on the high dose. There~     is preliminary evidence that polyphenol-rich foods can modify gut microbiota profiles, but~     this would be the first study to characterize the effects of daily strawberry consumption.~     The investigators are uniquely placed at the University of Arizona to enroll a larger~     percentage of Hispanic participants, who are often under-represented in clinical nutritional~     research. Results from the proposed study will improve understanding of how strawberries~     might promote health, and could provide further support for the incorporation of whole freeze~     dried fruit in dietary guidelines.~   "
3354|NCT03522961|"~     We aim to compare the effectiveness of cranberry capsules versus nitrofurantoin prophylaxis~     in preventing urinary tract infections (UTIs) after urogynecologic surgery by conducting a~     double-blinded randomized clinical trial involving women with pelvic organ prolapse and/or~     urinary incontinence scheduled to have surgery with the Urogynecologists who comprise the~     Brigham and Women's Urogynecology Group.~   "
3355|NCT03522948|"~     Open pilot trial to test the feasibility and efficacy of a brief intervention with text~     messaging to reduce sexual risk behavior and heavy drinking among MSM~   "
3356|NCT03522935|"~     A multiple-ascending-dose (MAD), randomized, placebo-controlled, blinded trial to evaluate~     the safety, tolerability, pharmacokinetics, and pharmacodynamics of Elafin in healthy adult~     subjects. The purpose of this study is to assess Elafin that is being developed for treatment~     of PAH. Elafin inhibits elastase, an enzyme that is increased in pulmonary hypertension and~     is a major factor in the development of PAH. Elafin will be administered subcutaneously daily~     for 7 days in normal healthy subjects followed over a 28 day time period.~   "
3642|NCT03519191|"~     The California Adolescent Health Collaborative (CAHC) brings together multiple nonprofit~     organizations in California's Central Valley to implement the Healthy Relationships and~     Economic Pathways (H-REP) program, which aims to increase and promote healthy relationships~     and stability among youth between the ages of 14 and 24.~   "
3357|NCT03522922|"~     This study aimed to evaluate the efficacy of dermaroller and topical vitamin C- either~     separate or combined- in treatment of post acne scars.~      prospective randomized clinical trial that was The study was a randomized controlled trial,~     conducted in Sohag Dermatology outpatient clinic between June 2016 and of February 2018. 30~     patients with acne scars were included.~      All patients were informed about the entire procedure, medication, possible side effects and~     outcomes. A written informed consent was signed from each participant.~   "
3358|NCT03522909|"~     In January 2017 investigators started a Center for Peripartum Optimization (CPO) with the aim~     of optimizing a patient's clinical status in an outpatient setting to minimize unnecessary~     laboratory tests and studies, costly inpatient consultations, the likelihood of post-surgical~     adverse events, escalations in level of care, inpatient admissions and readmissions. This~     research project seeks to evaluate the impact of this innovative concept on patient outcomes~     during the last 12 months. Investigators will accomplish this by collecting retrospective~     data from patients' electronic medical records in the intervention group and comparing it to~     data gathered from a controlled group of patients with similar comorbidities but who were not~     evaluated at the CPO clinic.~   "
3359|NCT03522896|"~     Orange juice naturally contains high concentrations of hesperidin, which affects glucose~     absorption in in vitro experiments. This study is to test if hesperidin and other components~     of orange juice (not other sugars or organic acids) affect the post-prandial blood glucose~     concentration derived from sugars already present in the orange juice.~   "
3360|NCT03522883|"~     The objective of the present study was to evaluate the MPF and the perception of effort of~     professional jiu jitsu athletes from carbohydrate intake at different moments. Twelve jiu~     jitsu athletes participated in the study, being randomly divided into three groups of four~     participants: Control Group (CG); Experimental group 1 (G1), supplementation immediately~     before the fight and Experimental group 2 (G2), supplementation 30 minutes before the fight.~     The FPM measurement was performed with the JAMAR® brand analog hydraulic dynamometer in the~     pre-fight moments and immediately after the fight. The intensity perception of the effort was~     verified through the adapted Borg scale after the fight. Regarding the findings on muscle~     strength, there were different outcomes between the groups analyzed.~   "
3361|NCT03522870|"~     This trial is a randomized, multi-center, parallel group, efficacy and safety study with a~     28-weeks follow- up. The study aims to: 1)compare the effects of novel flash glucose~     monitoring system (FGMS) and conventional Self Measurement of Blood Glucose (SMBG); and 2)~     optimize integrated management for glycaemic control in adult patients with type 1 diabetes~     who are sub-optimally controlled.~   "
3362|NCT03522857|"~     Chronic pain affects from one third to one half of the population in the UK (Fayaz et al,~     2016). The cost and burden of chronic pain is significant to health services worldwide. The~     affects of chronic pain are widespread upon the lives of those affected. Health professionals~     need to be better equipped than at present to manage pain and current chronic pain management~     knowledge in healthcare is poor. Briggs et al 2011 described the hours of pain education~     delivered at undergraduate level as 'woefully inadequate'. The International Association for~     Study of Pain (IASP) defined curricula for pain education at undergraduate level 6 years ago~     but current levels of knowledge at undergraduate health professional level are not widely~     known. This study aims to establish this at the outset of a pre-registration health~     professional courses and at the end of these courses.~      This study aims to identify the baseline knowledge and attitudes of pre-registration~     healthcare students in Universities throughout UK and Ireland toward chronic pain management.~     The disciplines targeted are nursing, midwifery, physiotherapy, occupational therapy,~     diagnostic radiography and paramedics.~      It is a cross sectional study that compares attitudes and knowledge of first year and final~     year pre-registration healthcare students in the UK and Ireland. These parameters are~     measured using the HC-PAIRS measure and Revised Neurophysiology Questionnaire respectively.~     In addition anonymous data is collected pertaining to participant characteristics which are~     institute of study, age, gender, level and discipline of study to enable a comparison between~     these parameters.~   "
3363|NCT03522844|"~     We propose the first randomized, controlled study to assess the comparative effectiveness of~     Mindfulness-Based Stress Reduction (MBSR) with a medication for anxiety disorders. We will~     use escitalopram, gold-standard SSRI treatment for patients with anxiety disorders, and will~     examine the comparative effectiveness of the two treatments on anxiety symptoms and other~     outcomes important to patients.~   "
3364|NCT03522831|"~     It is estimated that one in every 3,600 children in Canada has cystic fibrosis (CF). CF is a~     genetic disease that affects the glands that produce mucus and sweat. In CF, mucus production~     increases and the mucus becomes thick and sticky. This can block the airways, making it~     difficult to breathe. Mucus production also causes bacteria to grow, which can lead to~     infections in the lungs. Individuals with CF suffer from shortness of breath, wheezing,~     cough, and poor exercise capacity. There are limited treatment options to reduce shortness of~     breath in these individuals. Some medications known as bronchodilators are commonly~     prescribed to reduce breathlessness in patients with CF. These drugs help open the airways~     making it easier to breathe. Unfortunately, there is limited scientific proof that these~     drugs can reduce shortness of breath and improve exercise capacity in patients with CF. As a~     result, some experts have recommended that these drugs should not be prescribed for patients~     with CF. The purpose of this study is to examine the effects of a bronchodilator on shortness~     of breath, exercise performance, and breathing responses compared to a placebo drug in adults~     with CF.~   "
3365|NCT03522818|"~     The purpose of this study is to evaluate whether the bedwetting alarm trigger activated by~     parents to wake their child, in addition to the moisture alarm, will improve treatment~     success compared to the moisture alarm alone.~      During the study one group will use the alarm as provided by the manufacture and the other~     group will use the same model but will be instructed to manually trigger the alarm 1-2 hours~     after the child falls asleep.~   "
3408|NCT03522246|"~     This is a Phase 3, randomized, multinational, double-blind, dual placebo-controlled, 4-arm~     study evaluating rucaparib and nivolumab as maintenance treatment following response to~     front-line treatment in newly diagnosed ovarian cancer patients. Response to treatment will~     be analyzed based on homologous recombination (HR) status of tumor samples.~   "
12711|NCT03400449|"~     A randomized trial comparing LARC uptake and satisfaction after either video or~     conversational-based contraceptive counseling for pregnant women in labor.~   "
3366|NCT03522805|"~     Chronic obstructive pulmonary disease (COPD) is a highly prevalent condition worldwide and is~     a cause of substantial morbidity and mortality. Unfortunately, few therapies have been shown~     to improve survival. The importance of systemic effects and co-morbidities in COPD has~     garnered attention based on the observation that many patients with COPD die from causes~     other than respiratory failure, including a large proportion from cardiovascular causes.~     Recently, two high profile randomized trials have shown substantial improvements in morbidity~     and mortality with use of nocturnal non-invasive ventilation (NIV) in COPD patients with~     hypercapnia. Although the mechanisms by which NIV improves outcomes remain unclear, the~     important benefits of NIV might be cardiovascular via a number of mechanisms. In contrast to~     prior trials of NIV in COPD that did not show substantial benefit, a distinguishing feature~     of these encouraging recent NIV clinical trials was a prominent reduction of hypercapnia,~     which might be a maker or mediator of effective therapy. Alternatively, improvements might be~     best achieved by targeting a different physiological measure. Additional mechanistic data are~     therefore needed to inform future trials and achieve maximal benefit of NIV. Recent work in~     cardiovascular biomarkers has identified high-sensitivity troponin to have substantial~     ability to determine cardiovascular stress in a variety of conditions - even with only small~     changes. In COPD, a number of observational studies have shown that high-sensitivity troponin~     increases with worsening disease severity, and that levels increase overnight during sleep.~     This biomarker therefore presents a promising means to study causal pathways regarding the~     effect of NIV in patients with COPD. With this background, the investigator's overall goals~     are: 1) To determine whether the beneficial effect of non-invasive ventilation might be due~     to a reduction in cardiovascular stress, using established cardiovascular biomarkers, and 2)~     To define whether a reduction in PaCO2 (or alternative mechanism) is associated with such an~     effect.~   "
3367|NCT03522792|"~     Neurotensin (NT) is a gut peptide released postprandially from the small intestine. It is~     known to exert a range of enterogastrone effects and in animal models it reduces food intake~     when administered by parenteral routes.~      This study investigates whether the anorexic effects of NT suggested by animal studies can be~     translated.~   "
3368|NCT03522779|"~     To date, there are no published studies on the effects of tart cherry consumption on~     postprandial antioxidant and oxidative stress levels following a high-fat meal. Further, no~     one has looked at the effects of prior exercise on a high-fat meal that includes high~     phytonutrients like tart cherries. Therefore, the purpose of this study is to examine the~     effects of tart cherry consumption on antioxidant and oxidative stress levels in human plasma~     after consumption of a high-fat meal, as well as the postprandial impact of prior exercise in~     combination with tart cherry consumption on a high-fat meal.~   "
3369|NCT03522766|"~     The aim is to explore the human urine composition and its relation to urine tract infections~   "
3370|NCT03522753|"~     This study aims to determine if staples or sutures are better for the closure of~     uncomplicated foot and ankle surgeries. Currently, most surgeons base their choice for~     closure on previous teaching from a mentor during fellowship or personal experience. There is~     no standard of care for closure material on hand surgeries to date. This study will~     prospectively randomize patients to have either staple or suture wound closure if they have a~     short incision. In surgeries with longer incisions (i.e. 5+ cm), or multiple incisions on~     similar sites (i.e. bilateral operations, multiple toes), patients will have half sutures and~     half staple closure. The three primary measured outcomes will be: pain upon suture/staple~     removal, time to place and remove sutures vs. staples, and scar formation.~   "
3371|NCT03522740|"~     Good communication among patients, their families and loved ones, and their medical care~     providers is important when figuring out how to treat chronic diseases like kidney disease. A~     lot of people may not know all of their choices for how to treat kidney disease, and this can~     lead to rushed decisions or even a sense that there weren't any choices to make. In this~     study, the investigators are trying to find out if a decision-aid program on a computer can~     help people with kidney disease have more confidence in their decisions and have better~     agreement about their decisions with their families and loved ones.~      The DART study will be conducted at four sites in different areas of the country: Boston,~     Massachusetts; Portland, Maine; Chicago, Illinois; and San Diego, California. The study will~     enroll a total of 400 people with kidney disease at these four sites.~   "
3372|NCT03522727|"~     The aim of the present research is to test the effect of helping people to reward themselves~     when they have successfully lost weight and the impact this will have on subsequent weight.~     Each participant will be randomly allocated to one of four conditions. The trial requires 200~     participants to perform a fully powered statistical analysis. The four conditions are: (1) a~     control condition, (2) intervention 1 (form a single self-incentivising implementation~     intention from a drop-down menu), (3) intervention 2 (form multiple self-incentivising~     implementation intentions from a drop-down menu), or (4) intervention 3 (asked to form a~     single self-incentivising implementation intention of their own devising). The main outcome~     measure will be BMI, which will be self-reported.~   "
3373|NCT03522714|"~     The primary objective is to compare the efficacy of the FIS on closure rate to the AFB after~     2 weeks of operative debridement and closure.~   "
3374|NCT03522701|"~     Insomnia is the most prevalent sleep problem in both the general and clinical populations.~     Insomnia symptoms, presented as the problems initiating sleep or maintaining sleep, have been~     reported in association with adverse outcomes in adolescents, including an increased risk of~     developing depression, anxiety, interpersonal problems, somatic health problems, self-harm~     and suicidal ideation. Moreover, adolescent insomnia has been found to predict the~     development of mental health problems in young adulthood.~      Currently there is no medication specifically approved for use as hypnotics in children under~     age 18 by the US Food and Drug Administration (FDA). Although cognitive behavioural therapy~     for insomnia (CBT-I) has been regarded as the first-line treatment for insomnia in adults,~     there exists limited evidence for the efficacy of CBT-I among adolescents and young adults.~     Given the high prevalence and profound consequences of insomnia among youth, further research~     on the short-term and long-term effects of CBT-I for adolescents is warranted. To address the~     limitations of the existing literature, this randomised controlled trial aims to examine~     whether face-to-face (group-based CBT-I) versus self-help insomnia treatment benefit~     adolescents with insomnia, for improving sleep and other clinical and daytime symptoms as~     well as overall functional improvement in both the short and long term.~   "
3375|NCT03522688|"~     Acute kidney injury (AKI) following liver transplantation (LT) is associated with increased~     costs, morbidity, and mortality. Dexmedetomidine has known have anti-inflammatory effect and~     has been shown to ameliorate IRI in several organs. However, the impact of Dexmedetomidine on~     AKI after LT is not determined yet. Therefore, this study aims to observe the renal~     protective effects of Dexmedetomidine after LT.~   "
6153|NCT03486314|"~     The purpose of this study is to assess the effect of multiple-dose administration of rifampin~     on the single dose PK of pevonedistat in adult participants with advanced solid tumors.~   "
3378|NCT03522636|"~     Trauma is a leading cause of death among people younger than 44 years. Five million people~     worldwide die from trauma annually. Uncontrolled haemorrhage causing traumatic-haemorrhagic~     shock (THS) is the leading cause of potentially preventable deaths from severe trauma.~     Uncorrected hypervolaemia and prolonged shock cause severe tissue hypoperfusion, vital organ~     ischemia and subsequently acidosis. In up to one third of trauma patients, laboratory~     findings suggest traumatic induced coagulopathy, which is further triggered by loss or~     dilution of coagulation factors. These patients have a significantly increased morbidity and~     mortality compared to patients with similar injury patterns without coagulopathy. Minimizing~     the time to surgical control of haemorrhage is key in order to improve outcome. However,~     immediate and goal directed volume and coagulation resuscitation including use of blood~     transfusion is crucial to enable survival until definitive hospital care. The primary~     objective of this study will be to evaluate feasibility of prehospital administration of 1~     unit of human plasma and 1 unit of red blood cells, and explore association of early~     prehospital transfusion with early outcomes in patients presenting with THS, severe bleeding~     or peri-arrest state who are matching indication criteria and are transported by Helicopter~     Emergency Medical Service. Results of clinical examinations and laboratory variables in a~     group of patients receiving prehospital transfusion will be compared to matched population of~     patients treated before blood has been available on board. Secondary aim of the study is to~     detect any potential logistical and/or organisational adverse effects, incl.~     cost-effectiveness, in a regional trauma system with prehospital times (time of injury to~     trauma centre) ranging from 45 to 75 minutes.~   "
3379|NCT03522623|"~     inflammation of the gastrointestinal tract. A recent Canadian study from found that Canada~     has amongst highest incidence rates of childhood-onset IBD (10 per 100,000 for children~     <16y). In 2012, Crohn's and Colitis Canada estimated that direct medical costs of IBD in~     Canada were >$1 billion, and estimated indirect costs amounting to $1.8 billion. An American~     study demonstrated the direct costs of caring for children with IBD was double those for~     adults. Indirect health care costs in children with IBD have not been well-described. The~     Canadian Gastro-Intestinal Epidemiology Consortium (CanGIEC) is a pan-Canadian network of new~     and established IBD clinician-researchers and methodologists from 6 provinces experienced in~     the use of health administrative data. CanGIEC is evaluating variation in care of children~     with IBD, and will expand this research stream to assess direct and indirect cost of care.~     This will involve a collaboration with the CIHR/CHILD Foundation Canadian Children IBD~     Network (CIDsCaNN), which comprises an inception cohort of children diagnosed at all 12~     pediatric IBD centres across Canada.~      Hypothesis: Direct health costs are dominated by medication expenses (particularly~     biologics), with resulting variation within and across provinces in costs and out-of-pocket~     expenses to the families due to coverage disparity. Indirect costs include school and~     parental absenteeism, and productivity losses.~      Aims:~        1. Determine the cost of care of children with IBD, incurred by caregivers,across Canada.~          Costs include:~           a Indirect costs - costs to the patient or family related to having the disease but not~          to direct health care.~           b. Out of pocket (OOP) - costs paid in cash or credit for health-related expenses not~          covered by the public health or private insurance systems.~        2. Determine the sociodemographic and disease characteristics associated with higher costs~      Methods:~      Population: Incident cases of IBD (<16y) over 12 months (est. enrollment 250-300).~      Indirect and OOP disease-related costs will be determined with surveys conducted one year~     following diagnosis and every 6mo for 2y. These will be conducted querying families on the~     preceding 4 weeks including: school and work days missed, out-of-pocket expenses, distance~     travelled to appointments, medications expenses incurred, and disability benefits collected.~     Indirect costs will be calculated using the Human Capital Approach (gross income not earned~     due to disease).~   "
3380|NCT03522610|"~     The proposed project will produce and test the first combined group-online prevention program~     for reintegrating parents - ADAPT: After Deployment Adaptive Parenting Tools. We will~     conduct a randomized effectiveness trial of the program, compared with a 'services as usual'~     (tip sheet) comparison group among 400 military families identified in the RFA as a special~     population: reintegrating Army National Guard parents.~   "
3381|NCT03522597|"~     The objective of this pilot study is to compare breast milk composition in mothers of three~     different metabolic states (normal weight, obese, and gestational diabetic) and to determine~     the extent to which breastmilk components are transmitted to the infant gut and are~     associated with the anthropometric and body composition changes in their infants during the~     first 6 months of life. It is hypothesized that 1) different maternal metabolic states will~     be associated with differences in breastmilk microbial communities and breastmilk biochemical~     features, 2) differences in these breastmilk biomarkers will be transmitted to infants and 3)~     breastmilk microbial and metabolic features will be associated with infant growth outcomes.~   "
3382|NCT03522584|"~     This phase I/II trial studies the side effects of durvalumab, tremelimumab and stereotactic~     body radiation therapy in treating participants with head and neck squamous cell carcinoma~     that has come back or that has spread to other places in the body. Monoclonal antibodies,~     such as durvalumab and tremelimumab, may interfere with the ability of tumor cells to grow~     and spread. Stereotactic body radiation therapy is a specialized radiation therapy that sends~     x-rays directly to the tumor using smaller doses over several days and may cause less damage~     to normal tissue. Giving durvalumab, tremelimumab, and stereotactic body radiation therapy~     may work better in treating participants with recurrent or metastatic head and neck squamous~     cell carcinoma.~   "
3383|NCT03522571|"~     Altered passive eruption (APE) is an anatomical condition that is frequently diagnosed in~     periodontal clinical practice, especially for the ever-increasing demand of patients for the~     aesthetic improvement of their smile. In addition to its aesthetic value, however, altered~     passive eruption could also affect gingival and periodontal health. In fact, in the case of~     plaque accumulation, the altered passive eruption (APE) is likely to be a predisposing factor~     for a more rapid progression of gingivitis with higher inflammation indexes (Angulated~     Bleeding Score - AngBs and Modified Gingival Index - mGI). Notwithstanding, even if~     gingivitis in patients with altered passive eruption is developed much more rapidly, thorough~     home oral hygiene and plaque control conduces to complete clinical recovery. Further studies~     with a large number of patients are required to confirm the correlation between altered~     passive eruption and periodontal diseases.~   "
3384|NCT03522558|"~     The purpose of this study is to compare standardized nutrition therapy provided by a~     registered dietitian (RD) at regularly scheduled intervals to usual care in terms of the~     ability to improve growth parameters in medically complex infants in the pediatric outpatient~     setting.~   "
3385|NCT03522545|"~     Our overall objective is to assess the therapeutic efficacy and tolerability of Allogeneic~     Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) isolated from hematogenous~     bone marrow for treatment of treatment-resistant bipolar depression patient (TRBD).~   "
3386|NCT03522532|"~     The goal of the study was to ascertain the influence of dental caries and teeth position as~     well as the type and amount of the applied dental materials (DMs) on the oxidative stress~     (OS) status in gingival crevicular fluid (GCF).~   "
3387|NCT03522519|"~     Poststroke recovery mainly takes place within the first weeks to months and about 95% of the~     patients reach their maximum recovery 3 months after stroke onset. Poststroke rehabilitation~     is initiated as early as possible and aims to reduce functional consequences of stroke,~     allowing patients to integrate into the community. However, up to 75% of the patients remain~     disabled in the long term. Strikingly, about 20 to 30% of the patients show functional~     decline (i.e., learned-nonuse) in the long term - most often after having finished their~     intensive rehabilitation period - and even stroke survivors who have little or no residual~     disability are less physically active when compared to their age-matched peers.~      Poststroke outcomes can be well predicted early after stroke. However, the deficits early~     after stroke and the outcomes are measured by standardized clinical tests performed in the~     laboratory. The drawback of these tests is that they provide information about the best~     possible abilities of the patients, as they are encouraged by therapists in testing~     situations. This so called capacity does not necessarily reflect what patients do in daily~     life situations (i.e., performance or real world use).~      With the growing interest in the patients' performance, various assessments that objectively~     measure activities in daily life situations have been developed in the last few years. These~     devices capture movement in daily life situations in a sensitive and objective way. An~     additional benefit is that they are less hampered by floor or ceiling effects when compared~     to clinical laboratory measurements (i.e., clinimetrics). Nevertheless, outcome of real world~     performance is hardly ever used in clinical trials aiming to determine the effectiveness of~     stroke rehabilitation interventions. Actually, until today, the natural course of performance~     remains largely unknown, as are predictors for this course. It is also unknown to which~     extend patients' subjective reporting of performance matches objectively measured~     performance. Finally, although it is believed that there is a threshold for, for example,~     real life use of the paretic arm and further improvement, there is no evidence as to what~     this threshold is in terms of clinical laboratory measurements.~      The present prospective longitudinal cohort study fills in the gap regarding knowledge about~     the profile and predictability of two performance outcomes during the first year poststroke:~     engagement in physical activities and the use of the paretic upper limb. In addition, it will~     provide insight in how physical activity engagement and upper limb use measured by daily life~     assessments relate to standard clinical laboratory assessments. This knowledge is a~     prerequisite for the identification of patients' phenotypes and a first essential step~     towards the development of tailored (i.e., precision medicine), innovative rehabilitation~     interventions which enhance performance in terms of physical activities or upper limb use in~     daily life. The ultimate goal is to reduce poststroke disability and associated costs.~      RE-USE is a prospective longitudinal observational cohort study of 120 first-ever stroke~     patients, who will be assessed 3, 10, 28, 90 and 365 days after stroke onset, as well as at~     discharge of the rehabilitation center.~   "
3389|NCT03522493|"~     20 healthy young subjects and 20 healthy older subjects will go through a medical~     examination. Subjects will be asked for their medical history especially on respiratory and~     cardiac diseases. All subjects will go through a spirometry test to evaluate their~     respiratory function. After their medical clearance each subjects will be asked to wear a~     CBRN respirator for 45 minutes. 15 minutes without filter, 15 minute with 0.8 cmH2O~     resistance, and 15 minutes with 1.2 cmH2O resistance. Throughout the test, Pco2 AND PO2 will~     be measured. The investigator will evaluate the effect of resistance (filter resistance) and~     the age of the subject on CO2 accumulation in the mask.~   "
3390|NCT03522480|"~     The Effectiveness of the Jamboxx Respiratory Therapy Device in Treatment of Patients with~     Decreased Respiratory Function is a proposal for investigation of the application of gaming~     to improving respiratory health. The Jamboxx device combines gaming with traditional~     incentive spirometry to provide users with a fun experience to keep them engaged in their~     respiratory therapy routine. The device allows users to play a series of mini-games that walk~     them through their routines. The Jamboxx also records airflow and lung parameters with an~     external mouthpiece attachment to provide users with real time feedback, and helps to assess~     increases or decreases in relative lung function over time. The Jamboxx has the potential to~     significantly impact the field of respiratory therapy by being one of the first gaming~     devices for patient therapy, and the first respiratory therapy gaming device that is~     accessible to users with limited mobility. Jamboxx provides a fun and engaging, low cost~     alternative to the traditional therapy techniques used and aims to improve patient~     compliance.~      This study addresses the ongoing challenge of clearing the burden of bronchial secretions~     resulting from cystic fibrosis. These patients are dependent upon mechanical devices to help~     clear secretions. A device autonomous means for clearing secretions is well defined in the~     literature (autogenic drainage) but is difficult to learn. This study proposes to teach~     cystic fibrosis patients to master autogenic drainage, and seeks to determine at what age it~     can be taught. As it would be expected that gaming could easily teach adults this procedure,~     the study will include children for whom learning autogenic drainage based upon~     conceptualization would be expected to be very difficult.~   "
3391|NCT03522467|"~     This project represents a first systematic, prospective, single-arm cohort study of a safe~     and effective dosing regimen of an orally administered cannabis oil formulation in a cancer~     subject population with poorly controlled pain.~   "
3392|NCT03522454|"~     The PERFORM-TAVR trial (Protein and Exercise to Reverse Frailty in OldeR Men and women~     undergoing Transcatheter Aortic Valve Replacement) is a multicenter randomized clinical trial~     with a parallel-group design. The investigators will screen consecutive patients ≥70 years of~     age before TAVR and enroll those that have evidence of physical frailty defined as an SPPB~     score ≤8. The investigators will randomly allocate 220 patients to receive a multi-faceted~     intervention consisting of a home-based exercise program and a protein-rich oral nutritional~     supplement or usual lifestyle counselling. The primary endpoint is the change in SPPB score~     3-months post-procedure.~   "
3393|NCT03522441|"~     This is a randomized, double-blind, multiple-site, placebo-controlled, parallel-group study,~     designed to compare the efficacy and safety of generic Clindamycin 1% gel (Akorn), and the~     marketed product Clindamycin 1% gel (Greenstone LLC) in the treatment of acne vulgaris.~   "
3394|NCT03522428|"~     Pregnancy is associated with increased requirements for iron and increased blood volume of up~     to 40%. Because expansion in plasma volume is higher than the increase in the mass of red~     blood cells, there is a fall in hemoglobin concentration, which leads to physiological~     anemia, characterized with lower hemoglobin (Hb), hematocrit and red blood cells, but without~     changes in mean corpuscular volume (MCV). Anemia in pregnancy is defined with Hb values under~     110 g/L in the first trimester and under 105 g/L in the second and third trimester.~      Iron deficiency is thought to be the most common nutrient deficiency among pregnant women.~     Consequences of anemia include delayed fetal growth, premature delivery, intrauterine fetal~     death, postpartum depression and delayed psychomotor development of a child. It is known that~     in women that are not anemic daily iron supplementation of 27 mg/day is sufficient, which can~     be obtained from adequate nutrition or body supplies. Iron supplementation is pregnancy has~     been recommended by the WHO (World Health Organisation) since 1959, and this recommendation~     was confirmed by numerous professional associations. However, in women with anemia, or women~     subjected to particular dietary regimens with diminished quantity of iron, including~     vegetarian or vegan diet, required supplementation dosage is higher, and estimated in the~     literature to be 120 mg/day.~      The aim of this study was to analyze whether adding vitamin B12 (5 µg /100 days), along with~     folic acid and iron as supplement in pregnant women who are not anemic and who need only iron~     supplementation, will result in improvements of hematological and biochemical markers.~   "
3395|NCT03522415|"~     To compare the efficacy between the HLX01 group and the placebo group through the proportion~     of subjects meeting the ACR20 improvement criteria for remission~   "
3396|NCT03522402|"~     Children scheduled for tonsillectomy surgery were recruited into the study. General~     anesthesia was induced with 8% sevoflurane inhaled with 8 l.min-1 of oxygen via mask,~     followed by adjustment of inspired sevoflurane to the target concentration based on the~     result in previous patient at which laryngoscopy and tracheal intubation were attempted and~     maintained for 12 min. All responses to tracheal intubation were assessed. At the end of the~     procedure, sevoflurane was titrated to the target concentration, which was kept constant for~     12 min before a standard stimulus was applied to determine whether the children was awake.~     The Dixon's 'up and down'method was used to determine progression of subsequent~     concentrations.The aim of this study was to determine whether the minimum alveolar~     concentration of endotracheal intubation（MACEI）of sevoflurane in children with obstructive~     airway are different from that observed in normal children.~   "
3397|NCT03522389|"~     This study will investigate the effect of Action Observation Teaining (AOT) on gait variables~     and global cognitive functions in older adults with mild cognitive impairment (MCI).~      The specific objectives are 1) to compare gait variables and global cognitive functions among~     the AOT with gait training, gait training, and control groups at before training, after~     training, and follow up and 2) to compare gait variables and global cognitive functions among~     before training, after training, and follow up in each of the groups.~   "
6154|NCT03486301|"~     Phase 1 Open-Label Dose Escalation Study of BDB001 as a Single Agent and in combination with~     Pembrolizumab in Subjects with Advanced Solid Tumors~   "
3398|NCT03522376|"~     Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory lung disease that~     causes obstructed airflow from the lung, characterized by chronic cough, dyspnea, and sputum~     production. Inspiratory muscle weakness has been shown in patients with COPD, and inspiratory~     muscle training (IMT) is commonly applied to these patients. However, the optimal prescribed~     intensity of IMT for patients with COPD remains unclear. In healthy adults the accessory~     muscles would be recruited to assist ventilation with increasing ventilatory demand, but the~     activation pattern of accessory muscles has not been studied in patients with COPD during~     loaded condition such as IMT. Therefore, the purpose of this study is to exam diaphragm and~     sternocleidomastoid muscle activation using surface electromyography during loaded~     inspiratory muscle tests with intensity of 30% and 50% of maximal inspiratory pressure.~   "
3399|NCT03522363|"~     Pilot study with healthy subjects to test the in vivo potential colonization ability of S.~     dentisani. Phase I, exploratory, prospective, mechanistic pilot clinical trial with two~     parallel follow-up groups. Probiotic will be applied topically as an adhesive gel with a~     dental splint under different dosing regimes. Saliva and plaque samples will be obtained at~     day 0, 14 and 28.~   "
3400|NCT03522350|"~     The purpose of the study is to compare the current EmbryoScope Time-Lapse System being used~     in IVF which has become standard of care to the new model EmbryoScope to demonstrate that the~     EmbryoScope+ is as safe and reliable as the EmbryoScope.~   "
3401|NCT03522337|"~     Establishing good oral health-related habit is challenging among younger children, especially~     for preschool children with special needs, as they have physical, mental, sensory,~     behavioural, emotional, and chronic medical conditions that requires health care beyond the~     routines. Existing evidences showed that children with special needs have poorer oral health~     status and more challenging behaviours than their counterparts in main stream schools. Visual~     pedagogy, such as social stories, have been applied to teach a variety of skills or~     behaviours to individuals with special needs. They are short stories demonstrating the target~     skill or behaviour, and then the readers are expected to perform the target skill or~     behaviour following the demonstrations. Giving the evidence that children with special needs~     can understand complex situations and learn new practices by using those stories, we expect~     to apply a package of structured social stories to modify oral health-related behaviours~     (tooth brushing, healthy eating, dental visit), and thereby, improve oral health status among~     preschool children with special needs. Establishment of good oral-health related behaviours~     in early childhood will benefits children in their future life. Additionally, visual~     pedagogy-assisted oral health education is relatively easy and safe to implement. If proven~     effective, social story-based preventive care can be recommended to special children~     globally.~   "
3402|NCT03522324|"~     This study tests the effects of cannabinoid levels in blood on pain relief, inflammation, and~     cognitive dysfunction in chronic pain patients who choose to use edible cannabis. Over a~     two-week period, participants use an edible product of their choice. Blood levels of~     9-delta-tetrahydrocannabinol (THC) and cannabidiol (CBD) will be measured before, during, and~     after the two-week exposure period to determine whether there are associations with pain,~     inflammation, sleep, physical activity, anxiety/depression, and cognitive dysfunction. After~     the two-week self-administration period, participants will be followed for six months to~     collect self-report data on cannabis use, pain levels, sleep quality, and mental health~     symptoms.~   "
3403|NCT03522311|"~     The surgical outcomes of 25-gauge vitrectomy for proliferative diabetic retinopathy has been~     evaluated by preoperative glycemic control and renal function~   "
3404|NCT03522298|"~     This protocol has a 2-part design:~      The phase 2a study component is an open-label, multicenter, phase 2a dose-escalation and~     expansion study to assess the safety, tolerability, recommended phase 2 dose (RP2D),~     pharmacokinetics (PK) and clinical activity of GDC-0084 in patients with newly-diagnosed~     glioblastoma multiforme (GBM) with unmethylated MGMT promoter status as adjuvant therapy~     following surgical resection and initial chemoradiation with temozolomide (TMZ). The phase 2a~     study is fully detailed in this submission.~      The phase 2b study component comprises an evaluation of clinical activity of GDC-0084~     compared to TMZ in as adjuvant therapy following surgical resection and initial~     chemoradiation with TMZ and will be initiated following the determination of RP2D in the~     phase 2a study (Part 1). The phase 2b component will be will be further detailed in an~     amendment to this submission.~   "
3405|NCT03522285|"~     the study aims to determine rate of mortality and morbidity after total hip replacement in~     patients with chronic kidney diseases and incidence of periprosthetic joint infection in~     these patients.~   "
3406|NCT03522272|"~     Objectives: The objective of this study was to assess prospectively the effectiveness of~     ultrasonic denture hygiene interventions in improving denture cleanliness among~     community-dwelling elders. Methods: A randomized clinical trial was conducted among~     community-dwelling elders, in which a total of 66 subjects who received upper metal framework~     removable partial dentures in the past five years were recruited randomly from a computerized~     database. They were randomly allocated into three denture hygiene intervention groups: group~     1 (mechanical cleaning with a toothbrush and ultrasonic cleaning with cetylpyridinium~     chloride mouthrinse), group 2 (mechanical cleaning with a toothbrush and ultrasonic cleaning~     with distilled water) and control (mechanical cleaning with a toothbrush only). Denture~     cleanliness was assessed at baseline and one month review using: i) Denture Cleanliness Index~     (DCI) scores; ii) plaque coverage percentage; and (iii) microbiological tests. Results: There~     were significantly greater reductions in mean DCI scores and mean percentage of plaque~     coverage area in group 1 and group 2 compared to the control group for both CoCr and acrylic~     fitting surfaces (p<0.001). Group 1 had significant reductions in the viable counts of~     bacteria (CoCr and acrylic) and yeast (CoCr only) (p<0.05), while only significant reductions~     in bacterial viable counts (CoCr and acrylic) (p<0.05) were documented in Group 2. No~     significant differences were detected between groups 1 and 2 with regards to all clinical and~     microbiological outcomes. When comparing these parameters for CoCr and acrylic surfaces, no~     significant differences were observed following the intervention period. Conclusions: The~     ultrasonic cleaner was significantly more effective than the control in the reduction of~     biofilm coverage on metal framework removable partial dentures during the one month~     intervention period. The adjunctive use of cetylpyridinium chloride with ultrasonic cleaning~     did not yield improved outcomes compared to water.~   "
3407|NCT03522259|"~     The aim of this study is to investigate the efficacy and safety of rivaroxaban in obese~     patients undergoing bariatric surgery.~      The objectives are to assess the safety and feasibility of venous thromboembolism (VTE)~     prophylaxis and lung embolism with Rivaroxaban 10mg as an oral anticoagulant. After bariatric~     surgery patients receive the study medication Xarelto 10mg QD for 7, resp. 28 days.~      All clinically thromboembolic events will be assessed by ultrasound or CT, respectively, as~     soon as apparent. In addition, patients are screened for VTE at day 28 by ultrasound to~     detect clinically inapparent thromboses.~      In a subgroup of study patients (patients from the University Hospital Inselspital, Bern)~     PK/PD parameters are assessed following the last intake of rivaroxaban at day 28.~   "
3409|NCT03522233|"~     Acute appendicitis (AA) is the most common condition requiring emergency surgery in children.~     At a network of institutions nationwide, a tool called the pediatric appendicitis risk~     calculator (pARC)1 is being studied to assess patient's true risk of appendicitis and provide~     guidance for clinical management to ER physicians. Preliminary studies have found the pARC to~     be more accurate at predicting risk of appendicitis in children when compared to other~     scoring systems. The study objective is to assess acute care charges and clinical outcomes~     among children with an appendix ultrasound and a pARC score of less than < 25% risk.~   "
3410|NCT03522220|"~     Current pathophysiological models of schizophrenia focus on disconnectivity of distributed~     neuronal systems to explain the multitude of psychic symptoms. However, therapeutic~     strategies targeting this specific pathobiology are lacking. Our recent work provides strong~     evidence that complex video-game training interventions facilitate fronto-hippocampal~     structural and functional connectivity within 2 months in healthy subjects. The planned~     project transfers this knowledge into a training study in schizophrenic patients to~     counteract disease-related disconnectivity. Underlying mechanisms and behavioral effects are~     extensively parametrized by resting state functional magnetic resonance imaging (fMRI),~     diffusion tensor imaging (DTI), spectroscopy and clinical short- and long-term outcome.~   "
3411|NCT03522207|"~     The objective is to evaluate the accuracy and efficacity of 1 dose of trazodone in TMD~     patient (with chronic orofacial pain and poor sleep quality).~      Subject will have 3 polysomnography (PSG) over 3 weeks. The first one being the baseline.~      Half of the patient will receive trazodone on their 2nd PSG and placebo on their 3rd PSG, and~     the other half will receive placebo bedofe their 2nd PSG and trazodone for the 3rd PSG.~      Pain quality and sleep quality will be assessed before and after PSG. polysomnograms from~     baseline, placebo night and trazodone night will also be compared.~   "
3412|NCT03522194|"~     Diastolic dysfunction is an important cause of hemodynamic instability in the perioperative~     field.Therefore this study aims to investigate the influence of existing diastolic~     dysfunction or deterioration of diastolic function on hemodynamic stability during induction~     of anesthesia and postoperative complications. The impact of different anesthetics on~     diastolic function is investigated.~   "
3413|NCT03522181|"~     Lactic acidosis is a common phenomenon occurring during orthotopic liver transplantation~     (OLT), especially during the anhepatic and early postreperfusion phases. However, little~     drugs effectively decrease the degree of lactic acidosis when it happens. The aim of this~     study is to explore whether glucose-Insulin-Potassium(GIK) infusion can relieve metabolic~     acidosis and improve perioperative outcome in patients undergoing OLT.~   "
3414|NCT03522168|"~     The purpose is to evaluate the long-term pathologic weight changes associated with multi-year~     risperidone or aripiprazole therapy in 3 - <18-year-old children, who have varying durations~     of prior antipsychotic drug exposure from the start of study Month 0 (M0). This is critical~     because children appear to have greater vulnerability to antipsychotic-associated weight gain~     than adults, and obesity has significant effects on morbidity and mortality.~   "
3415|NCT03522155|"~     Investigators will conduct a randomized trial to determine if providing patient-specific life~     expectancy estimates during treatment counseling via a targeted, patient-centered~     communication approach improves shared decision making and reduces rates of overtreatment of~     genitourinary malignancies.~   "
3416|NCT03522142|"~     The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics,~     pharmacodynamics, and early clinical activity of single-agent INCB081776 (Part 1) and~     INCB081776 in combination with nivolumab (Part 2).~   "
3417|NCT03522129|"~     This is a multi‐center, Phase 1b, randomized, double‐blind, placebo‐controlled parallel‐group~     trial in adults with mild to moderate AD.~   "
3418|NCT03522116|"~     This a prospective observational study including patients with ST-segment elevation~     myocardial infarction undergoing cardiovascular magnetic resonance for clinical reason during~     the index hospitalization. This local registry stemmed from multi-center european registry on~     cardiovascular magnetic resonance~   "
3419|NCT03522103|"~     This project examines the effects of cannabis on cognition and other domains of function and~     whether those effects are dependent upon the ratio of THC to CBD in the product. Current~     cannabis users are asked to stop using their typical product and to use cannabis containing~     different ratios of the cannabinoids THC and CBD. Participants complete baseline assessments~     including cognitive tasks, clinical measures, substance use history, and blood draw.~     Participants then acquire and use their study strain on their own, and after a period of use~     the mobile pharmacology laboratory goes to a location of their choosing. They complete~     cognitive, motor and blood-based assessments, then leave the mobile lab to use their study~     product one last time, returning to the mobile lab to complete cognitive, motor, and~     blood-based assessments immediately after use and one hour after use. A small subset of~     participants complete all of these procedures but use edible as opposed to flower-based~     products.~   "
3420|NCT03522090|"~     This is a study comparing routine inclusion of the lower neck in initial CT thorax in~     patients with suspected lung cancer to not including it. The study aims to assess whether~     such an intervention reduces the number of invasive investigations required to achieve a~     final diagnosis and clinical stage and whether it improves the detection of cervical lymph~     nodes involvement by lung cancer.~   "
3421|NCT03522077|"~     The primary objective of this open label study is to compare the rate of vascular~     complications associated with the use of the SoftSeal®-STF hemostatic pad in subjects~     undergoing transradial catherization when compared to the VascBand™ Hemostat. Patients will~     be randomized after radial access is achieved in 1:1 for each group.~   "
3422|NCT03522064|"~     The purpose of this study is to determine the efficacy of BAT in men with metastatic~     castrate-resistant prostate cancer (mCRPC) and homologous recombination deficiency (HRD).~     Bipolar androgen therapy will be administered to men confirmed to have HRD on tumour tissue~     and/or circulating tumour DNA analysis on pre-screening.~   "
3423|NCT03522051|"~     Many deep carious teeth are treated unnecessarily by root canal therapy, while with using~     current techniques and advances in compatible dental materials in addition to better~     understanding of biological response of the dental pulp, many can be treated conservatively~     via vital pulp therapy procedures.~   "
13246|NCT03393468|"~     The purpose of this study is to evaluate the pharmacokinetics of dapivirine gel administered~     rectally to HIV-1 seronegative adults.~   "
3424|NCT03522038|"~     The aim of this study is to investigate the role of functional evaluation for predicting~     clinical outcome in patients with coronary chronic total occlusion (CTO) undergoing~     percutaneous coronary intervention (PCI), and to evaluate the clinical evidence for the using~     of fractional flow reserve (FFR), coronary flow reserve (CFR), index of myocardial resistance~     (IMR) and dynamic single photon emission computed tomography (D-SPECT) in these patients.~   "
3425|NCT03522025|"~     Unicompartmental knee arthroplasty (UKA) is the principal surgical alternative to the total~     knee arthroplasty (TKA) in patients with end-stage unicompartmental tibiofemoral~     osteoarthritis (OA) of the knee. The current comparative randomized study aims to evaluate~     the fixation of cemented and cementless designs of GMK-UNI unicompartmental knee prosthesis~     over a 5-year time period.~   "
3426|NCT03522012|"~     This is a randomized, double-blind, 3-arm, parallel-group single-dose study to compare the~     PK, PD, safety, tolerability, and immunogenicity of LusiNEX (Mycenax tocilizumab) versus~     RoActemra (EU tocilizumab) and Actemra (US tocilizumab) after a single IV infusion of 4 mg/kg~     in healthy volunteers (hereafter referred to as subjects). The therapeutic dose of~     tocilizumab starts with 4 mg/kg and ranges to 12 mg/kg, considering 4 mg/kg is the lowest~     dose, the same has been selected for the study.~   "
3427|NCT03521999|"~     Behavioral health problems among Veterans have raised awareness of the critical need for more~     reliable, effective, and accessible ways to recognize those in need, direct them to help, and~     ensure that they receive the best evidence-based care available. AboutFace is a novel peer~     education program that features the personal stories of Veterans and is designed to improve~     Veterans' likelihood of engaging in PTSD specialty care. Using a randomized controlled study~     design the investigators propose to compare the efficacy of AboutFace relative to standard~     care for improving treatment engagement and outcomes. Additional data from VA providers will~     provide valuable information on wide scale implementation and dissemination of AboutFace. If~     AboutFace increases access of services, data will have broad implications for overcoming~     barriers to care for Veterans with PTSD and other stigmatized conditions.~   "
3428|NCT03521986|"~     Thoracoscopic assisted mediastinal thymectomy is currently one of the most commonly used~     surgical methods, but there are some deficiencies.Minimally invasive surgery through the~     subxiphoid approach can achieve a good surgical field of vision. (1) The surgical field is~     fully exposed. (2) damage to intercostal nerves can be avoided.(3) Operation time,~     intraoperative blood loss, postoperative Extubation time is similar to VATS. But there is~     still lack of evidence.~      In this study, 50 patients undergoing subxiphoid uniportal VATS and 50 patients undergoing~     intercostal uniportal VATS were included to evaluate the post-operative pain and quality of~     life after surgery.~   "
3429|NCT03521973|"~     This study is a single site, randomized, double-blind, placebo-controlled trial. The trial~     will assess the safety, tolerability, immunogenicity and vaccine efficacy (VE) of PfSPZ~     Vaccine in Gabonese children that are naturally exposed to malaria parasites. Healthy~     children aged 1- 12 years living in the surrounding areas of Lambaréné and/or Fougamou~     Province in Gabon will be eligible for participation.~   "
3430|NCT03521960|"~     This is a pilot study to collect preliminary data to support a grant application. The goal of~     the study is to evaluate whether the Food and Drug Administration (FDA)-approved and~     generically-available medication buspirone reduces symptoms of opioid withdrawal among~     patients undergoing a clinically-indicated and supervised taper from their opioid pain~     medications. This is premised on strong preclinical scientific support but has not yet be~     well-examined in humans.~   "
3431|NCT03521947|"~     Pancytopenia is an important hematologic Problem.it is a decrease in all three cellular~     elements of peripheral blood leading to aneamia, leucopenia and thrombocytopenia.~   "
3432|NCT03521934|"~     Primary Objective:~        -  To demonstrate that sotagliflozin reduces cardiovascular (CV) mortality and morbidity~          (composite of CV death or hospitalization for heart failure [HHF]) compared to placebo~          in hemodynamically stable patients with type 2 diabetes (T2D) and heart failure (HF)~          with left ventricular ejection fraction (LVEF) <50%, after admission for worsening heart~          failure (WHF).~        -  To demonstrate that sotagliflozin reduces cardiovascular (CV) mortality and morbidity~          (composite of CV death or hospitalization for heart failure [HHF]) compared to placebo~          in hemodynamically stable patients with T2D and HF irrespective of LVEF after admission~          for WHF.~      Secondary Objectives:~        -  To demonstrate that, when compared to placebo in the toal patient population,~          sotagliflozin reduces the total number (i.e., including recurrent events) of the~          following clinical events:~        -  Cardiovascular death, HHF or urgent HF visit.~        -  To demonstrate that, when compared to placebo, sotagliflozin reduces:~        -  The composite of positively adjudicated sustained ≥50% decrease in eGFR, chronic~          dialysis, renal transplant or positively adjudicated sustained eGFR <15 mL/min/1.73 m2~          in the total patient population.~        -  Cardiovascular death in patients with LVEF < 50%.~        -  Cardiovascular death in the total patient population.~        -  All-cause mortality in patients with LVEF < 50%.~        -  All cause mortality in the total patient population.~        -  To demonstrate the safety and tolerability of sotagliflozin in the total population in~          this study.~   "
3444|NCT03521778|"~     Relatively new method of diagnosing and treating dysfunction of the musculoskeletal system is~     Fascial Distortion Model. It is manual therapy developed by emergency physician and an~     osteopath Stephen P. Typaldos.~      Disfunction are diagnosed based on verbal and physical descriptions, palpations, anamnesis.~     As a result of examination, It can be found one or more of six different distortions. The aim~     of the study is to examine the effectiveness of FDM manual therapy in comparison to manual~     therapy using the Mulligan Concept method and traditional physiotherapy in patients with~     shoulder dysfunction who have undergone previous rehabilitation and who have not achieved~     satisfactory results. Patients will receive five treatments with one day brake between each~     treatment. The patient's condition will be evaluated before the first treatment, two weeks~     after the last treatment, and also after three months. As a outcome of the occurring~     phenomenon, structural changes are planned at the level of the fascial system in the studied~     region. The obtained results may influence the current views on diseases of the~     musculoskeletal system, as well as on the method of diagnosing and treating shoulder joint~     dysfunction.~   "
6708|NCT03479034|"~     A prospective qualitative and quantitative controlled study, exploring the impact of patient~     centred digital prescriptions on health, in patients with chronic health conditions.~   "
3433|NCT03521921|"~     The current state of the art management of severe mitral regurgitation is surgical mitral~     valve repair, either with open chest surgery or mini-thoracotomy. However, standard surgical~     approaches requiring cardiopulmonary bypass are suitable for patients with low or moderate~     surgical risk, thus many patients are denied surgery because of unfavorable risk-benefit~     balance. The EuroHeart Surveyconducted by the ESC showed that one half of patients with~     severe mitral regurgitation were denied surgical treatment because they were felt to be at~     too high risk for surgery by the referring physician. Such patients are usually elderly and~     have co-morbidities. Thus, there is a need for novel devices enabling interventional~     cardiologists and cardiothoracic surgeons to perform mitral repair in a minimally-invasive~     fashion and possibly without cardiopulmonary bypass. The landmark EVEREST II trial randomized~     279 patients with grade 3/4 MR in a 2:1 fashion to MitraClip® or surgical repair/replacement~     showing a lower major adverse event rate at 30-days in the MitraClip® group (15.0% vs. 48%;~     superiority p<0.001), mainly driven by the need for blood transfusion with surgery, and the~     primary efficacy endpoint of freedom from the combined outcome of death, new surgery for~     mitral valve dysfunction or the occurrence of >2+ MR was achieved in 55% vs. 73%~     (non-inferiority p=0.007). However, this study has included a highly selected patient cohort~     in which patients with significant surgical risk have been excluded. More recently,~     Multinational (ACCESS-EU, EVEREST-High Risk) and national registries (TRAMI, SWISS) have~     shown safety and efficacy in the real world experience. Patients currently treated are high~     risk, elderly, with comorbidities and mainly affected by FMR. There is need for an Italian~     registry, since Italy has produced the second largest volume of transcathetermitral~     procedures in the world after Germany. The present registry is designed to collect real world~     clinical data on early and long-term outcomes following percutaneous mitral regurgitation~     therapy in consecutive patients undergoing transcatheter procedures in Hospitals linked to~     the GISE database.~   "
3434|NCT03521908|"~     A study to compare the risk of a major bleeding in participants who received 2 different~     blood thinning medications following a blood clot~   "
3435|NCT03521895|"~     The aim of this integrated analysis is to describe the effectiveness of Eylea in an~     integrated pooled analysis using existing individual patient data of two non-interventional~     studies RAINBOW and PERSEUS.~      The primary objective of this integrated analysis is to describe the effectiveness of Eylea~     on the mean change from baseline in visual acuity (VA) at 12 months in Wet age-related~     macular degeneration (wAMD) treatment naïve patients.~   "
3436|NCT03521882|"~     Stroke is caused by sudden changes in blood flow in the brain. This can be fatal or can~     result in permanent disability. A fast diagnosis is essential to initiate effective~     interventions and optimize benefits to patients. There are other diseases that can look like~     a stroke and these are called stroke mimics. The quicker that stroke mimics can be ruled~     out the faster a stroke can be diagnosed and treatment can be given. The investigators may be~     able to use chemicals in the blood to rapidly confirm that a person has had a stroke. One~     such chemical is called eotaxin. Eotaxin has been found to be changed in sufferers of a~     stroke but not in those with stroke mimics. However, more research is needed to confirm the~     usefulness of eotaxin. This feasibility study aims to provide the foundations to allow a~     large scale trial of this test. The study aims to recruit participants that have had a stroke~     or a stroke mimic from the Acute Stroke Unit and Stroke clinic at the Royal Devon and Exeter~     Hospital. Up to 6 blood samples will be taken from each participant at different times over~     one week. Eotaxin will be measured in these samples and in participant's leftover samples~     taken for clinical care. This is needed because the investigators know that the amount of~     eotaxin changes in the blood after a stroke but we do not know how quickly this change~     happens and for how long the change occurs. The study will also allow the investigators to~     understand how many participants will be needed for a large scale trial and the challenges~     that may be faced in recruiting participants.~   "
3437|NCT03521869|"~     The purpose of this study is to evaluate if applying a compression bandage on the leg alters~     early outcome following TKA.~      The primary objective of this study is to evaluate leg swelling by measuring leg~     circumference following simultaneous bilateral total knee arthroplasty (TKA) with and without~     the application of compression bandage.~   "
3438|NCT03521856|"~     This research study will investigate in a 12-week home exercise program to see whether it is~     effective in improving shoulder pathology and reducing shoulder pain in persons with chronic~     spinal cord injury. The research study will involve ultrasound shoulder examinations of your~     shoulders using a non-invasive medical ultrasound machine, as well as clinical shoulder~     examinations and completion of a number of pain questionnaires.~   "
3439|NCT03521843|"~     This study will evaluate the effectiveness and safety of local drug delivery using TAPAS~     balloon catheter system in the treatment of femoropopliteal in-stent restenosis. Patients~     with femoropopliteal in-stent restenosis will randomly receive balloon dilation or balloon~     dilation plus local drug delivery using balloon catheter system. Their clinical outcomes~     (e.g. 12-month late lumen loss or late lumen loss at secondary intervention within 12 months,~     6-month and 1-year patency rate of target vessel) in 1 year after the treatment will be~     compared.~   "
3440|NCT03521830|"~     This is a phase 2 trial assessing the efficacy of nivolumab, alone or in combination with~     ipilimumab in treating patients with locally-advanced unresectable or metastatic basal cell~     carcinoma.~   "
3441|NCT03521817|"~     The objective of the proposed study is to enroll women with obesity that will undergo a~     controlled, energy restricted feeding intervention to test the effects of chronic ethanol~     consumption on adipose distribution and circulating testosterone during weight loss.~   "
3442|NCT03521804|"~     The objective of this study is to evaluate the safety and efficacy of the SoundBite™ Crossing~     System - Coronary (SCS-C) in a subject population with chronic coronary artery disease~     including Chronic Total Occlusion (CTO).~   "
3443|NCT03521791|"~     Title of the study Efficacy and safety of PRO-155 (Zebesten ofteno®) on inflammation of the~     conjunctival surface in subjects with grade I-III pterygium vs placebo.~      Hypothesis H0. The Zebesten® ophthalmic solution (bromfenac 0.09%) is less effective and safe~     than placebo in reducing conjunctival hyperemia in subjects with grade I-III pterygium.~      H1 The Zebesten® ophthalmic solution (bromfenac 0.09%) is more effective and safe than~     placebo in reducing conjunctival hyperemia in subjects with grade I-III pterygium.~      Objective~      To evaluate the efficacy and safety of PRO-155 (bromfenac 009%) ophthalmic solution in the~     treatment of conjunctival hyperemia and ocular surface inflammation in a clinical model of~     pterygium grade I to III.~   "
3455|NCT03521635|"~     The main objective of the study is to explore firstly, then further evaluate and confirm the~     efficacy between Pramipexole Sustained Release (SR) versus Pramipexole Immediate Release (IR)~     on nocturnal symptoms (as measured by the change from baseline to the end of the maintenance~     period in Parkinson's Disease Sleep Scale 2nd version (PDSS-2) score) in L-dopa+ treated~     patients with advanced Parkinson's disease (PD).~   "
3445|NCT03521765|"~     BACKGROUND:~      Colorectal cancer (CRC) and its treatment affect CRC survivors' quality of life (QoL),~     emotional distress and activities of daily living (ADL). It is assumed that occupational~     therapy interventions based on cancer education may be a feasible approach.~      Aim To examine the effect of using cancer education based on healthy lifestyle by~     occupational therapist on QoL, emotional distress, ADL and healthy lifestyle behaviors in CRC~     survivors.~      Methods Participants with CRC were designed as a two-group controlled trial, and a~     single-blind randomized controlled trial was conducted. These participants were randomly~     assigned to either an OT intervention or a non-intervention group (in a 1:1 ratio). Those~     participants in the OT intervention group were given a consultation based on a CRC education~     handbook by an occupational therapist for discharge preparation and on 1-month, 3-month~     follow-up clinic; the non-intervention group participants were given a CRC education handbook~     (the same handbook) only for discharge preparation. The primary outcome was the change in QoL~     measured using WHOOQOL-BREF. Secondary outcomes were changes in emotional distress, ADL and~     healthy lifestyle behaviors. Outcomes were examined in baseline (discharge preparation),~     1-month and 3-months follow-up clinic.~   "
3446|NCT03521752|"~     This study has the objective to determinate the effectiveness of a specific exercise program~     on balance and functional capacity of the daily activities of institutionalized elderly.~      It was a randomized controlled trial with a total of 21 elderly that were randomly~     distributed into experimental (n = 11) and control groups (n=10). The experimental group~     performed a specific program exercises during 4 weeks, while the control group wasn't~     subjected to any intervention. Evaluations were carried out at the beginning and end of the~     exercise program, for both groups. After the intervention there were no statistically~     significant differences between groups in total balance and dynamic balance subscale, except~     static balance subscale.~   "
3447|NCT03521739|"~     A multicenter prospective registry planned to recruit more than 100 000 patients 50 years old~     and older was carried out in China. This primary purpose of this study was to evaluate the~     association of synchronous four-limb blood pressure and pulse wave velocity with~     cardiovascular events. The secondary purpose was to evaluate the incidence rate,prevalence~     rate, value of diagnosis for peripheral arterial occlusive disease, and to follow up the~     effects of revascularization on cardiovascular events.~   "
3448|NCT03521726|"~     Helicobacter pylori (H. pylori) is the most common chronic bacterial infection in humans.~      The prevalence of H. pylori is about 30~50% in the Western adult population. It is estimated~     that about 50% of people are infected with this bacterium in Taiwan. Many studies have shown~     that H. pylori is an important causal factor of chronic gastritis, peptic ulcer disease,~     gastric cancer and gastric lymphoma. The World Health Organization classified H. pylori as a~     Group 1 carcinogen in 1994. Endoscopic examination is indicated to confirm the above~     diagnosis for patient with H. pylori infection. Eradication of H. pylori infection reduces~     the risk of gastric cancer and recurrence of peptic ulcer disease. However, the eradication~     rate of clarithromycin-based triple therapy has been declining in recent years, probably~     related to the increasing resistant rate to clarithromycin. Several strategies have been~     proposed to overcome the declining eradication rate, including (1) extending the treatment~     duration of triple therapy to 14 days; (2) the use of bismuth quadruple therapy which~     contains bismuth, a proton pump inhibitor, and two antibiotics (usually metronidazole and~     tetracycline); (3) non-bismuth quadruple therapy (concomitant therapy) which contains a~     proton pump inhibitor and three antibiotics (usually amoxicillin, metronidazole, and~     clarithromycin); (4) sequential therapy which contains a proton pump inhibitor (PPI) plus~     amoxicillin for five days, followed by a PPI plus clarithromycin and tinidazole for another~     five days. The investigators aim to evaluate the efficacy of Amoxicillin powder in the~     Intraluminal therapy for Helicobacter pylori infection while an endoscopic examination is~     performed.~   "
3449|NCT03521713|"~     This study is to evaluate 24-week efficacy and 52 week immunogenicity of subcutaneous Eporon~     versus Epoetin Alfa (Eprex) in the treatment of anemia associated with chronic renal failure~     in pre-dialysis patients. A total of 214 patients will be enrolled in Turkey.~   "
3450|NCT03521700|"~     Although expert consensuses recommend the use of statins in the treatment of atherosclerotic~     renal artery stenosis, in patients with severe atherosclerotic renal artery stenosis~     undergoing stent placement, the related investigation focused on renal protection by~     intensive lipid-lowering therapy is scant , and the optimal target level for lipid reduction~     remain uncertain. Therefore, we hypothesized that intensive lipid lowering could offer more~     benefits with respect to renal function in the patients with percutaneous renal artery~     stenting. We conducted the prospective randomized unblinded trial to compare the~     renal-protective effect of intensive lipid lowering with that of conventional lipid lowering~     in patients underwent renal artery stenting (75 patients in each study group)~   "
3451|NCT03521687|"~     This is a single-center, open-label clinical study to study the efficacy of apremilast in the~     treatment of mild to moderate central centrifugal cicatricial alopecia. The investigators~     hypothesize that the anti-inflammatory properties of apremilast may play a role in the~     decreasing scalp inflammation in patients with CCCA and may prevent further hair loss and~     potentially induce hair regrowth in patients with mild to moderate disease.~   "
3452|NCT03521674|"~     The efficiency of double-balloon and Foley catheters in the second trimester medical~     termination of pregnancies will be compared.~   "
3453|NCT03521661|"~     Balloon kyphoplasty is a well-established treatment option to achieve pain relief and to~     correct kyphotic deformity caused by osteoporotic vertebral compression fracture. However, it~     has been demonstrated that reduction is partly lost as balloon is deflated in the vertebral~     body. An intravertebral expander was developed for better reduction and maintenance of~     vertebral body height while cement is injected. This study evaluates the efficacy of~     kyphoplasty with a new intravertebral expander with regard to correction of kyphosis angel~     and to restoration of vertebral body height.~   "
3454|NCT03521648|"~     This registry study aims to collect data on efficacy and safety of different treatments of~     benign prostatic enlargement (BPE) and lower urinary tract symptoms associated with benign~     prostatic hyperplasia (BPH-LUTS).~   "
3456|NCT03521622|"~     Randomized clinical trial that aims to determine the effectiveness of a counseling~     intervention to modify the stage of behavioral change in risk behaviors (smoking and risky~     alcohol consumption) in patients candidates for scheduled surgery or diagnostic procedures at~     the Hospital Universitario de San Ignacio. Bogotá-Colombia~   "
3460|NCT03521570|"~     This phase II trial studies how well intensity-modulated radiotherapy and nivolumab work~     together in treating participants with head and neck squamous cell cancer that has come back.~     Intensity-modulation radiation therapy uses varying intensities of radiation beams to kill~     cancer cells and shrink tumors, thereby reducing the damage to nearby healthy tissue.~     Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to~     grow and spread. Giving intensity-modulated radiation therapy and nivolumab may work better~     at treating head and neck squamous cell cancer.~   "
3461|NCT03521557|"~     In order to provide information that will improve therapy, the goals of this project are to~     determine if persons with MS with complaints of dizziness and at risk for falls can improve~     their balance and vision stability as a result of a bout of specific treatment. This project~     seeks to do this by conducting an experiment where people with MS are randomly assigned to a~     group that practices activities known to help improve inner ear function or a group that~     practices activities known to improve endurance and strength but that should not change inner~     ear function. Such a comparison will allow us to gain understanding of how the inner ear~     system is affected in MS and how it responds to treatment.~   "
3462|NCT03521544|"~     The study investigates the relation between different segments of the posterior myofascial~     chain of the human body.~      The intervention consists on apply self-myofascial release with a foam roller in one of the~     segments of the posterior myofascial chain of the participants, and then see if the treatment~     has produced any changes in the hamstrings, gastrocnemius and soleus flexibility.~   "
3463|NCT03521531|"~     The main objective of the study is to assess the treatment situation of sarcoma patients in~     Germany and to investigate their potential influence on Quality of Life (and other Patient~     Reported Outcomes) of the affected persons. Impaired quality of life domains and factors~     associated with it are to be identified.~      To this end, a national network of sarcoma treatment specialists and a structure for patient~     recruitment will be established. This care network is intended to reflect the current~     situation of the treatment of sarcoma patients in Germany.~   "
3464|NCT03521518|"~     The study will collect prospective cohort data of individuals that are undergoing routine~     clinical care for suspected idiopathic Normal Pressure Hydrocephalus (NPH). The~     administration of the Conner's Continual Performance Test - version 3 (CPT-3), an automated~     14-minute computerized measure of reaction-time and sustained attention, will be added to the~     current neurocognitive screen being used (i.e., the Montreal Cognitive Assessment, MoCA)~     along with gait assessment. Patients will undergo pre-tap testing on the morning of their~     large volume Lumbar Puncture (CSF-TT). These patients will receive post-tap CPT-3 and MoCA~     testing one-to-three hours post-tap, and again at 2-3 days post-CSF-TT, during the follow-up~     appointment in clinic.~      The standard NPH quantitative assessment methods of MoCA and gait evaluation will continue to~     be collected. For those patients that ultimately undergo ventricular shunt placement, the~     CPT-3 will be administered at their post-operative follow-up appointment (~3 months~     post-operation). The results of CPT-3 will not factor into consideration for shunt candidacy.~   "
3465|NCT03521505|"~     Preventing hypoxemia is one of the major goal of studies for bronchoscopic sedation.~     Dexmedetomidine is a sedative agents via α2 adrenergic agonist, with little respiratory~     suppression. In the preset study, we evaluate the safety and feasibility of the~     Dexmedetomidine in the specific bronchoscopic procedure, endobronchial ultrasound~     (EBUS)-guided transbronchial needle aspiration.~   "
3466|NCT03521492|"~     Studies that give people vitamin D supplements to prevent caries have found that vitamin D is~     effective at preventing the development of caries.~      The aim of Study:~      To determine if there is a relationship between vitamin D deficiency and the development of~     Early Childhood Caries (ECC).~   "
3467|NCT03521479|"~     Primary Objective: To assess local and generalized adverse events with repeat topical~     application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent~     herpes labialis (4 or more episodes in the previous 12 months).~      Secondary Objective: To assess efficacy of repeat topical application of 2% and 0.5% SADBE in~     the prevention of herpes labialis episodes.~   "
3468|NCT03521466|"~     The purpose of this randomized control trial is two- fold. The primary hypothesis of the~     study is that smoking cessation counseling delivered through trained medical students will~     lead to higher rates of abstinence amongst patients in the intervention group, as compared to~     a control group, when measured by self-reported and biochemical testing at 6 months after~     enrolment .~      The secondary hypothesis is that medical students engaging in a structured curriculum that~     includes counseling hospitalized smokers will show demonstrable increases in knowledge,~     confidence in their abilities, and use of smoking cessation techniques in regular practice.~   "
3469|NCT03521453|"~     Pre-anesthesia visit for scheduled surgery is mandatory by law in France. During this visit,~     patients should be informed of the different available technics of anesthesia (i.e. general~     or loco-regional) and of their own risks .~      Nowadays, many informations are given through written paper and leaflets, just before the~     consultation. In addition, patients need usually to wait for the doctor. This time may be~     used to give information, and new information's support, such as videos, may be used.~      The aim of this study is to evaluated if a robot (PEPPER), who is able to answer to patients~     and to give informations, may increase the satisfaction of patients having a pre anesthesia~     visit for a scheduled surgery.~   "
3470|NCT03521440|"~     Therapeutic relaxation has shown benefits for improving health and quality of life of~     community dwelling elderly people. Although little is known about the efficacy of a specific~     method of therapeutic relaxation - Psychomotor Massage - compared with other relaxation~     methods. Therefore, the present study aims to examine the effects of two therapeutic programs~     (Psychomotor Massage and Progressive Muscle Relaxation) on health and quality of life~     indicators of community dwelling elderly people. This randomized controlled trial will~     include an intervention period of 8 weeks for control and for the two experimental groups -~     attending 30-minute sessions, twice a week - and a follow-up period of 4 weeks without~     intervention. The evaluation will be performed 1) at baseline, 2) at post-intervention and~     pre-follow-up, and 3) at post-follow-up. The main study variables will be: daily activities,~     psychomotor abilities, cognitive functioning, emotional states, pain perception, quality of~     sleep, body awareness and body image, and quality of life. Health biomarkers will be also~     assessed through saliva analyses.~   "
3473|NCT03521401|"~     The process by which the body responds to stressors to maintain homeostasis is called~     allostasis and is dependent on the integrated function of the nervous, endocrine, and immune~     systems. ACEs adversely affect these system, cause allostatic load, and can modify~     development of allostatic systems. However, the central hypothesis is that exercise can~     reduce allostatic load by positively augmenting function of each of these three systems. No~     previous studies have examined the effects of structured exercise interventions in~     individuals with ACEs. The investigators are studying the effects of 8-weeks of structured~     resistance and aerobic exercise on biomarkers related to nervous, endocrine, immune, and~     metabolic function and several clinical outcomes in young adult women with ACEs. The specific~     aims will test several hypotheses, and are as follows: SPECIFIC AIM 1: Conduct a feasibility~     study to explore whether progressive, structured exercise can help mitigate the adverse~     physiological effects of stress and trauma early in life. SPECIFIC AIM 2: Determine whether~     progressive, structured exercise can help improve health-related quality of life, anxiety,~     and traits like hope, self-efficacy, or self-control, resilience. SPECIFIC AIM 3: Determine~     whether the type and timing of exposure to ACEs has a significant influence on the severity~     of psychopathology and long-term physiological response to ACEs.~   "
3474|NCT03521388|"~     Background: Depression is prevalent and can have devastating effects on the life of~     adolescents. Computerized intervention programs for depression have shown positive results.~     There is less evidence in prevention and early treatment for depression in Latin American~     adolescents.~      Purpose: The purpose of this study is to determine whether a stepped internet-based program~     is effective to prevent and early intervene depression in adolescents attending 9th to 11th~     grade in eight schools in Santiago, Chile.~      Study design: A two-arm cluster-randomized clinical trial will be carried out with~     approximately 600 adolescents.~   "
3475|NCT03521375|"~     Lung cancer is the leading cause of cancer death worldwide and survival in the United Kingdom~     (UK) remains amongst the lowest in Europe. Surgery is the main method of managing early stage~     disease and is traditionally undertaken via conventional open surgery. However, over the last~     decade there has been a surge in the number of minimal access resections performed using~     Video-assisted thoracoscopic surgery (VATS). However, there remains a need for well-designed~     and conducted randomised controlled trial (RCT) to provide the evidence base for the wide~     spread uptake and delivery of this surgical approach.~   "
3476|NCT03521362|"~     The overall objective of the proposed research is to improve HbA1c, adherence to treatment~     plans, and family communication surrounding adolescents' self-management of T1D. The~     investigators will test the efficacy of the MyT1DHero app against an attention control group.~     This will allow investigators to better understand the health and psychosocial improvements~     being made through the app.~   "
3477|NCT03521349|"~     The aim of this study is to examine the correlational and intervention effects of egg~     consumption on macular carotenoids, cognition, and achievement during childhood. Initially,~     this will be done with correlational examination of egg consumption and macular carotenoids.~     Individuals with low carotenoid status will be invited to participant in a month-long~     egg-based dietary intervention aimed at improving carotenoid status.~   "
3478|NCT03521336|"~     This study aim to evaluate the safety and efficacy of intrathecal transplantation of~     allogeneic umbilical cord derived mesenchymal stem cells (UC-MSC) for treatment of different~     phrases of spinal cord injury. Here, the history of spinal cord injury is divided into three~     periods, Sub-acute SCI, Early stage of chronic SCI, and Late stage of chronic SCI, which is~     2W-2M, 2M-12M, and more than 12M after injury, respectively. The purpose is to investigate~     whether the patients with spinal cord injury benefit from UC-MSC transplantation, and then~     find out the best time for SCI treatment.~      In this part of the study, the investigators will treat patients with sub-acute spinal cord~     injury with UC-MSC transplantation or placebo.~   "
3479|NCT03521323|"~     This study aim to evaluate the safety and efficacy of intrathecal transplantation of~     allogeneic umbilical cord derived mesenchymal stem cells (UC-MSC) for treatment of different~     phrases of spinal cord injury. Here, the history of spinal cord injury is divided into three~     periods, Sub-acute SCI, Early stage of chronic SCI, and Late stage of chronic SCI, which is~     2W-2M, 2M-12M, and more than 12M after injury, respectively. The purpose is to investigate~     whether the patients with spinal cord injury benefit from UC-MSC transplantation, and then~     find out the best time for SCI treatment.~      In this part of the study, the investigators will treat patients with early stage of chronic~     spinal cord injury with UC-MSC transplantation or placebo.~   "
3480|NCT03521310|"~     The World Health Organization recommend all stable low birth weight neonates to have~     Skin-to-skin-Contact (SSC) after birth. Intermittent SSC is used in Sweden in neonatal units.~     Observations indicate that SSC makes neonates feel good. However, there is limited research~     done on SSC treatment on neonates born prior to week 33.~      The aim of this study is to investigate whether Skin-to-skin-Contact (SSC) leads to an~     improved physiological stabilization, altered epigenetic profile and improved longterm~     psychomotor outcome in neonates born in gestation age between week 28+0 - 32+6. This is a~     parallel, two-arm, multicentre, randomized controlled superiority trial. The two arms to be~     compared are a) immediate SSC with one parent/caregiver continous during the first 6 hours~     after birth and as much as possible during the first 72 hours, and b) conventional method of~     care during the same time.~   "
3481|NCT03521297|"~     The Comparison of curative effects of UDCA combined probiotics with single UDCA therapy in~     primary biliary cholangitis of poor response to UDCA: A Randomized Controlled Trial~   "
3482|NCT03521284|"~     Health education is now a major public health issue. In the field of perinatal care, the~     interests involved are the upgrading of the role of mother / father in the health education~     of their child and the disengagement of inappropriate pediatric consultations and emergency~     services in front of mothers who  fail know how to . A recent review of the literature~     (Cochrane Library) on the effectiveness of parenting programs in the first 2 months of life~     of the newborn shows that parental education programs focusing on the explanation of newborn~     rhythms to young parents increased sleeping time to 6 weeks of life or a significant~     improvement in the prevention of domestic accidents (checking the water temperature and~     reducing the risk of burning, sleeping in the bed and preventing unexpected sudden death of~     the infant, position and respect of instructions during transport by car and prevention of~     road accidents). However, the authors of this meta-analysis concluded that new studies were~     needed to confirm the results already published.~      The main objective of this study is to evaluate the effectiveness of an early parental~     education program in maternity both in terms of parental acquisitions and their~     implementation after leaving the service. These parental acquisitions relate, on the one~     hand, to the care to be given to the newborn child and, on the other hand, on the possible~     pathologies that he or she could have, and the best action to be taken by the parents to~     respond to them. The secondary objective is to evaluate the impact of this program on~     maternal anxiety in this special period of transition to the role of a parent.~      It is a prospective, monocentric, comparative, randomized, controlled, open study. The~     comparison will be made between two experimental groups. The first experimental group~     corresponds to the mothers who attended the education program during their maternity stay.~     The second control group corresponds to mothers who did not attend the training. The primary~     endpoint for measuring this effectiveness is maternal knowledge assessment using knowledge~     questionnaires that will be completed by mothers before (pre-test) and after (post-test) the~     educational program in the maternity unit. The secondary endpoints for assessing the primary~     objective of measuring this effectiveness are the maternal knowledge assessment 1 month after~     leaving the maternity, using a questionnaire (Recall-Test) and the assessment of the appeal~     to a medical consultation for the newborn child in the first month of life and the analysis~     of the relevance of this recourse to the care. The criterion of evaluation of the secondary~     objective to measure the impact of the educational program on maternal anxiety will be based~     on questionnaires tested regarding parental anxiety in the perinatal period (STAI-Etat)~     before and after the educational program.~      The investigators believe that this improvement in parental knowledge will have a positive~     impact on maternal anxiety in the first month of life and will lead to an improvement in the~     appropriateness of the use of care during the first month of life. If these results are~     confirmed, this educational program will have a real medico-economic impact (relieving~     emergency departments and improving the prognosis of newborns with severe pathologies and~     taken into care earlier by decreasing in parallel the duration of hospitalization).~      The impact of these results will allow to promote more widely the health education in the~     perinatal and neonatal period by generalizing this educational program in other maternities~     which could be interested. Also, it will allow to propose this educational program in~     prenatal (within the framework of session of preparation for the birth), after the release~     from the service, within the framework of structure of health such as the PMI, the community~     centers and medical structures, even the distribution of these educational program on a~     larger scale by means of media such as dedicated web site or smartphone applications.~   "
3483|NCT03521271|"~     The aim of this study, determining the factors affecting the hand functions of children with~     Duchenne Muscular Dystrophy who have lost their independent ambulatory ability and~     determining the effects on the overall upper extremity performance and quality of life of the~     determined factors.~   "
3543|NCT03520491|"~     The purpose of this study is to test if immunotherapy with nivolumab alone or in combination~     with ipilimumab is safe and does not delay the planned bladder cancer surgery. The~     investigators want to see if treatment with these drugs prior to surgery may decrease the~     size of the bladder cancer and thus could help make the surgery more successful.~   "
3544|NCT03520478|"~     The aim of this study is to compare the safety and efficacy of SHR3680 with bicalutamide in~     the treatment of patients with hormone sensitive prostate cancer.~   "
3484|NCT03521258|"~     Extremity wounds with exposed critical structures, including bone and tendon are a major~     burden on the American healthcare system with limited treatment options. Free Flap~     reconstructions of lower extremity wounds have an increased failure rate in comparison to~     elective free flap procedures.These procedures are long and are associated with a high cost~     of care, prolonged hospital stays, and are limited by the need for surgical specialist~     availability and patient vessels suitable for anastomoses. This study will use a new~     treatment modality which is a commercially ready human amniotic membrane allograft (EpiFix)~     to promote a granulation tissue wound base that will be suitable for skin grafting, thus~     forgoing the need for a flap-based for reconstruction. The study goals are to reduce the~     overall cost of providing definitive treatment by decreasing operative time, length of~     hospital stay, decrease the need for intensive nursing care and rehabilitation. This study~     will aim to provide a treatment option that is readily accessible to all patients with these~     complex wounds in any healthcare setting across the country.~   "
3485|NCT03521245|"~     The purpose of the study is to identify molecular markers at the level of molecular pathway~     activation to predict efficacy of anti-HER2 therapy with Trastuzumab.~   "
3486|NCT03521232|"~     This will be a phase I/IIa, open-label, three-stage, single center study aimed at~     investigating the safety, the efficacy (clinical and endoscopic effects) and the~     pharmacokinetics of Niclosamide enema 150 mg/60 ml and 450 mg/60 ml in subjects with~     mild-to-moderate UP and UPS, defined as a Modified Mayo Score (MMS) ≥ 4 and < 8, with a stool~     frequency subscore (SFS) ≥ 1, a rectal bleeding sub-score (RBS) = 1 or 2, and an endoscopic~     subscore (mucosal appearance) = 1 or 2. At the endoscopic sub-score any degree of friability~     will be classified as having a sub-scale score of 2.~   "
3487|NCT03521219|"~     The propose of this study is to confirm safety and efficacy of Apatinib monotherapy in~     patients with advanced cholangiocarcinoma.~   "
3488|NCT03521206|"~     Advance care planning (ACP) is a process that supports adults at any age or stage of health~     in understanding and sharing their personal values, life goals, and preferences regarding~     future (medical) care. ACP is of particular relevance for frail older adults, particularly in~     the nursing home setting where an important proportion of older people die. However, the~     actual implementation of ACP in nursing home practice seems to be a challenge in many~     countries worldwide, and people often do not get the opportunity to discuss their preferences~     in advance. This study evaluates the effectiveness of a theory-based advance care planning~     training programme (ACP+ programme) for nursing homes in Flanders, Belgium, using a cluster~     randomised controlled trial (cRCT) design. The ACP+ programme aims to integrate ACP in~     routine nursing home care by training the nursing home staff and management. Residents and~     their family will receive in-depth information on ACP and participate in one or several ACP~     conversations, if they wish so.~      Who can participate? Nursing homes that conform to the eligibility criteria: at least 100~     beds, situated in Flanders and did not participate in a similar research or implementation~     project over the last 4 years.~      What does the study involve? The researchers will perform a cluster randomized controlled~     trial (cRCT) to evaluate the effects of an ACP training programme in nursing homes in~     Flanders (Belgium), accompanied by a process evaluation. Fourteen nursing homes will be~     randomized to either the intervention group, which will receive the intervention (ACP+~     programme), or the control group, in which no additional training regarding ACP (other than~     that which is part of routine practice) will be provided. The nursing homes in the control~     group will receive a short training on ACP, as well as all training materials used in the~     intervention after the last follow-up measurements.~      At month 0 the researchers will perform a baseline measurement in the intervention and~     control groups using structured questionnaires to be filled in by all care staff in the~     nursing home. At the end of month 8, the same questionnaires will be administered again in~     all nursing homes (follow-up). The process evaluation will employ structured diaries for ACP~     trainers, attendance lists for training sessions, audiotaping of a sample of ACP~     conversations and individual and group interviews with staff and management of the~     intervention homes.~      Hypotheses The primary hypothesis is that the introduction of the ACP+ programme in nursing~     homes will improve the knowledge and attitudes of nursing home care staff regarding advance~     care planning.~   "
3489|NCT03521193|"~     Migraine is a common, chronic neurovascular disorder characterized by attacks of severe~     headache, autonomic nervous system dysfunction and, in some patients, aura, and disabling~     neurological symptoms. Worldwide, migraine prevalence is as high as 18% in the general~     population. Increased frequency of patent foramen ovale (PFO) in migraineurs was first~     reported in 1998 in a case-control study. Since then, others have described a 60% prevalence~     of PFO in patients suffering from migraine with aura. The presence of a right-to-left shunt~     (RLS) is thought to be a potent trigger of migraine attacks, although the mechanism is~     unknown. Moreover, PFO closure has correlated with improved migraine symptoms in several~     retrospective uncontrolled studies. The aim of this single-center, prospective study is to~     assess the impact of PFO closure on migraine attacks over time together with evaluation of~     potential predictive risk factors.~   "
3490|NCT03521180|"~     This is a model development, open label, no therapeutic treatment, three sequential group,~     short term-gluten challenge study in subjects with celiac disease. Immune responses are~     evaluated following gluten challenge.~      Approximately fifteen subjects with celiac disease will be enrolled in up to three sequential~     groups (5 subjects per group).~   "
3491|NCT03521167|"~     Pain after cardiac surgery can be moderate to severe with incisions to the sternum and lower~     extremities, and also the placement of chest tubes. Postoperative pain may contribute to~     delirium, stress, myocardial oxygen demand supply imbalance, etc. Traditionally postoperative~     pain management after cardiac surgery has been based on opiate analgesics. However, opiates~     have many deleterious side effects including nausea/vomiting, ileus, bladder dysfunction, and~     respiratory depression, which substantially influence patient recovery and may delay~     discharge after surgery.~      The current study is designed to evaluate if an opiate sparing multimodal regimen of tylenol,~     gabapentin, ketamine, lidocaine and dexmedetomidine provided better analgesic effect (pain~     score, postoperative PCA opioid dose), less side effects (PONV) and improved cardiac surgery~     outcome (delirium, a-fib, AKI, dysglycemia) compared to a traditional fentanyl and~     hydromorphine regimen after cardiac surgery. Additionally, it aims to investigate if the~     benefit of multimodal regimen is achieved by combination of all drugs or all drugs except~     dexmedetomodine by introducing third group of study patients who will be randomized to all~     interventions except saline placebo instead of dexmedetomodine infusion.~   "
3492|NCT03521154|"~     A global study to assess the efficacy and safety of osimertinib following chemoradiation in~     patients with stage III unresectable Epidermal Growth Factor Receptor Mutation Positive~     non-small cell lung cancer~   "
3505|NCT03520985|"~     Pomalidomide is an approved treatment for refractory multiple myeloma. Toxicity of~     pomalidomide in the pivotal MM-003 trial, was considerable, with 60% of patients experiencing~     drug-related G3/4 toxicity. Neutropenia (48% vs 16%) and pneumonia (13% vs 8%) were~     significantly more common in the pomalidomide arm. This resulted in frequent dose~     interruptions (67%) and dose reductions (27%). This suggests that for the majority of~     patients the 4 mg daily dosing schedule is too toxic, and that strategies to deliver reduced~     dosing of pomalidomide are of high practical relevance. The aim of this trial therefore is to~     establish that alternate day dosing of pomalidomide (4 mg q2d, d1-28) is non-inferior to~     daily dosing (4 mg d1-21 q28) in terms of efficacy of the drug with potentially less side~     effects.~   "
3493|NCT03521141|"~     Precision Care (PC) interventions, developed with guidance from a Community Advisory Board~     (CAB), will be piloted in a Randomized Clinical Trial (RCT) of approximately 100 eligible,~     consenting daily smokers in the Southern Community Cohort Study (SCCS) who are willing to~     make a quit attempt with medication and who reside in TN or MS. Participants will be~     randomized 1:1:1 to 1 of 3 groups; (1) group one informs selection of medication with~     information on nicotine metabolism; (2) group two offers a genetically-informed lung cancer~     risk score, and (3) group 3 is Guideline-Based Care (GBC). All groups will be followed for 6~     months. All RCT participants will receive FDA-approved smoking cessation medication, be~     referred to the shared TN/MS state quitline, and be offered the NCI Clearing the Air~     standard intervention. The primary outcome is feasibility of delivering the precision~     interventions in the SCCS population, as evidenced by ability to recruit, engage, and retain~     participants through end of study. Secondary outcomes, for which the study is not powered,~     will include risk perceptions, use of quit aids, lung cancer screening among those who are~     eligible, and smoking cessation.~   "
3494|NCT03521128|"~     Hydrosalpinx (HX) has a detrimental effect on the rates of implantation, pregnancy, live~     delivery, and early pregnancy loss during in vitro fertilization (IVF). The effectiveness of~     radiological tubal blockage has not been compared with the standard treatment of laparoscopic~     salpingectomy in randomized trials. The investigators aim in this randomized trial to compare~     the live birth rate of radiological tubal blockage versus laparoscopic salpingectomy in~     infertility women with HX prior to frozen-thawed embryo transfer (FET). Eligible women will~     be recruited and randomized into one of the following two groups: (1) the radiological tubal~     blockage group and (2) the laparoscopic salpingectomy group. The primary outcome is the live~     birth rate.~   "
3495|NCT03521115|"~     An online, interactive web-based program for older teens and their parents is designed to~     address teen alcohol use and teen relationships. The parent-teen dyad both participate in the~     web-based program and engage in off-line discussion activities. This intervention promotes~     communication skills, refusal skills, and helps teens consider how to make healthy choices.~   "
3496|NCT03521102|"~     Intravenous opioids are the mainstay of acute, severe pain treatment in U.S. EDs.~     Acetaminophen, given orally, has also been used for treatment of mild to moderate pain. The~     more potent intravenous (IV) form of acetaminophen has been widely used in Europe for more~     than 20 years as post-surgical analgesia and received full FDA approval in the USA in 2010.~     As part of a continuing set of studies whose goal is to optimize treatment of pain among~     elderly ED patients, we will conduct a randomized study in which we compare efficacy and~     safety of IV acetaminophen to IV hydromorphone.~   "
3497|NCT03521089|"~     This study evaluates the application of non-invasive brain stimulation in the treatment of~     Mild Cognitive Impairment (MCI) in adults aged 55-85. Half of the participants will receive~     transcranial direct current stimulation (tDCS), while the other half will receive sham (like~     placebo) stimulation.~   "
3498|NCT03521076|"~     Measure pain and anxiety during a putative painful medical procedure (i.e., botulinum toxin~     injections) when Virtual Reality is employed compared to standard of care only using a RCT~     study design.~   "
3499|NCT03521063|"~     This study evaluates the addition of budesonide to poractant alfa to prevent bronchopulmonary~     dysplasia in preterm infants with respiratory distress syndrome. Half of the participants~     will receive budesonide and poractant alfa in combination, and the other half will receive~     poractant alfa with saline.~   "
3500|NCT03521050|"~     All patients having an ICD implanted and having follow-up at the investigators center are~     included in this retrospective ICD lead registry from 2006 onwards. Data is collected~     propspectively from december 2016 onwards. After certain ICD-leads tended to fail early the~     investigators aimed for a registry monitoring our patient population with defibrillator leads~     and evaluating their long-term performance.~   "
3501|NCT03521037|"~     Phase 1, open-label, parallel group, PK, safety and tolerability study in patients with an~     advanced solid tumor and either normal hepatic function (Group 1, n = 8) or moderate hepatic~     impairment (Group 2, n = 8) according to the NCI-ODWG criteria. Patients in Group 1 and Group~     2 may be enrolled in parallel, with preferential enrollment of Group 2 patients before Group~     1 patients. The study will consist of 2 parts: a single-dose PK part (Part I) and a~     continuous rucaparib treatment part (Part II).~   "
3502|NCT03521024|"~     aim of study is to evaluate esthetic and biomechanical outcome of maxillary anterior~     single-tooth zirconia implant supported PEKK crowns compared to lithium disilicate crowns on~     PEKK abutments .~   "
3503|NCT03521011|"~     The acute abdomen is one of the most frequent causes for presentation to the emergency~     department. Imaging plays an important role for an accurate diagnosis, which in turn~     diminishes morbidity and mortality Jastaniah and Salih demonstrate optimum CT aspects and~     emphasize on the important features of CT for those patients presenting with an acute~     abdominal pain at the Emergency Department. The reported data by this study are based on the~     author working experience, which forms a continuous protocol adjustment process. The present~     study provides evidence that CT would result in definite diagnosis of patients with abdominal~     pain in terms of the detection of some urgent conditions . The acute abdomen may be defined~     generally as an intra-abdominal process causing severe pain and often requiring medical or~     surgical intervention. The acute abdomen is a frequent entity at the Emergency Department,~     the acute abdomen may be life threatening and so rapid diagnosis of patients presenting with~     acute abdominal pain is required . Diagnostic work-up with imaging can consist of plain~     X-ray, ultrasonography (US), computed tomography (CT) and even diagnostic laparoscopy. During~     the last decade, a trend towards increased use of computed tomography in patients with~     abdominal pain can be seen. In general, acute abdominal pain is responsible for about 10% of~     total number of patients visiting the emergency. Quick and precise diagnosis for the urgent~     cases is usually vital for treatment. Medical imaging is commonly used for the diagnosis of~     most acute abdomen pain. Abdomen and pelvis are reviewed by CT scan. Specifically, in cases~     of acute abdomen complain.~   "
3504|NCT03520998|"~     This study is evaluating the safety, tolerability, and feasibility of GRF6019, a~     plasma-derived product, administered as an intravenous (IV) infusion, to subjects with mild~     to moderate Alzheimer's disease.~   "
3506|NCT03520972|"~     This is a multicenter, randomized, double-blind, placebo-controlled, parallel dose cohort,~     multiple dose study to evaluate the efficacy, safety, and tolerability of different doses of~     PB-119 in drug-naïve subjects with T2DM.~   "
3509|NCT03520933|"~     Abnormal chromosome number, or aneuploidy, is common in human embryos. It is responsible for~     more than half of all miscarriages, and it is the leading cause of congenital birth defects.~     Besides, it has been described that aneuploidy may also affect embryo implantation.~     Therefore, selecting embryos that have the best chance of implanting and growing into a~     healthy baby is one of the most important steps in the field of assisted reproduction.~      Recent advances in genetic technologies, such as Next-Generation Sequencing (NGS), have~     allowed aneuploidy to be detected with greater sensitivity. The application of this technique~     to trophectoderm biopsies, taken from embryos before transfer to the uterus, has provided~     insight into the clinical impact of chromosomal status. This process of screening embryos to~     make sure they have the right number of chromosomes and to look for any structural~     abnormalities in the chromosomes is called Preimplantation Genetic Testing for Aneuploidy~     (PGT-A). It requires specific equipment and trained personnel that will add costs and risks,~     so non-invasive techniques are sought as an alternative. These non-invasive procedures has~     been explored by some groups analyzing the spent culture medium where the embryo is incubated~     up to the time of transfer or freezing. In daily routine, this media is discarded after~     finishing the embryo culture, but it has been reported that contains traces of embryonic~     cell-free DNA (cfDNA) that can represent the genetic load of the embryo. However, at the~     moment there is a high variability in results across studies, with a percentage of concordant~     results between the media and the trophectoderm biopsy ranging from 3.5 to 85.7%.~      Thus, the main objective of this project is to validate a new non-invasive method for PGT-A~     (niPGT-A), based on improved collection and analysis of the culture media to achieve higher~     rates of sensitivity and specificity and to decrease the effect of some intrinsic~     difficulties such as low embryonic cfDNA input, mosaicism and maternal contamination.~   "
3510|NCT03520920|"~     Screening (up to 28 days); BGB-3111160 mg twice daily in combination with rituximab until~     disease progression, discontinued treatment due to intolerance, died, withdrew from study, or~     completed study treatment for a total of 2 years, treatment (up to 2 years), safety follow up~     (30 days); survival follow-up until patient death or study termination by the Sponsor.~   "
3511|NCT03520907|"~     This study compares the transversalis fascia plane block with the~     ilioinguinal/iliohypogastric nerve block in children undergoing hernia repair surgery.~      Half of participants will receive the transversalis fascia plane block, while the other will~     receive the ilioinguinal/iliohypogastric nerve block.~   "
3512|NCT03520894|"~     The aim of this study is to prospectively evaluate, in patients affected by early breast~     cancer, safety and feasibility of single fraction radiotherapy with Cyberknife R in~     preoperative setting, and to identify factors predictive for outcome based on biologic and~     clinical parameters.~   "
3513|NCT03520881|"~     This project seeks to develop and pilot test the pediatric ASTHMA-Educator mobile~     application.~   "
3514|NCT03520868|"~     To observe, using a prospectively designed study, the effect of type of oral anticoagulant on~     intra-procedural heparin requirements in patients undergoing Atrial Fibrillation ablation and~     to assess whether ACT assay accurately reflects heparin anti coagulation effect.~   "
3515|NCT03520855|"~     The aim of this study is to evaluate the contribution of a serious game in the reinforcement~     of knowledge acquired during therapeutic education of type 1 diabetes paediatric patients.~      This evaluation will take place within 3 months of the diagnosis.~   "
3516|NCT03520842|"~     This phase II trial studies how well regorafenib works together with methotrexate in treating~     participants with metastatic non-squamous non-small cell lung cancer with tumors that harbor~     a KRAS mutation. Regorafenib is a targeted therapy that works on different cancer pathways to~     stop the growth of tumor cells and stop them from spreading. Methotrexate may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth. Giving regorafenib and~     methotrexate together may work in treating participants with KRAS mutated non-small cell lung~     cancer.~   "
3517|NCT03520829|"~     The process of developing Gamma Knife radiosurgery treatment plans is today very dependent on~     the level of human expertise resulting in a great heterogeneity of the intrinsic qualities of~     the treatment planning and the quality of care delivered in radiosurgery.~      The existing reverse planning systems, although they have progressed considerably in recent~     years, produce results that are still lower than those achieved by an expert.~      Conventionally, an experienced dosimetric planner will act mainly on the coordinates of the~     position of the isocenters, on the size of the collimators, sector by sector, and on the~     irradiation time of each isocenters. In theory, the combination of these variables provides~     access to billions of combinatorics whose diversity far exceeds the computational~     capabilities of the human mind. The dosimetric planner therefore uses a very small part of~     the spectrum of possible patterns by always reproducing a limited number of empirical~     solutions.~      The company Intuitive Therapeutics has developed a new mathematical algorithm which can~     automatically test in a very short time all the combinatorial possibilities and converge very~     quickly to the solution that best meets the clinical, anatomical and dosimetric objectives~     defined by the neurosurgeon. The quick processing of the system also allows the operator to~     modify the constraints to refine the proposed result in real time.~      The demonstration of the reality of the performances of this algorithm would give the ability~     to even inexperienced users to develop high performance planning for the benefit of the~     patient in terms of optimizing the efficacy / toxicity ratio of the radiosurgery treatment~     results~      The primary objective is to evaluate comparatively the quality of the schedules produced by~     the algorithm developed by the company Innovative Therapeutics to those produced by an expert~     who carried out more than 15000 dosimetric plannings and radiosurgical interventions.~      The main criterion of comparison is the Paddick index.~      The secondary criteria for comparison are:~        -  Compliance index~        -  selectivity index~        -  Gradient index~        -  Maximum, minimum, average dose at risk structures~        -  Dose distribution in the target volume~        -  Treatment time (at equal source activity)~        -  Time of realization of the planning~      It was chosen to treat patients with vestibular Schwannoma OR multiple brain metastases (> 5)~     treated in single session by Gamma Knife OR para-optic meningioma in hypo-fractionated~     treatment on Gamma Knife with restraint mask with inclusion of visual paths in the target~     volume planning.~      The aim of the study is to show at least the non-inferiority of this new method compared to~     the expert user based on the Paddick Index. This index has continuous values between 0 and 1,~     0 being the worst case and 1 being the ideal solution. In order to define the sample size~     needed for each pathology, a pilot phase is required. This phase can be performed~     retrospectively using treatments already defined by the expert user. This pilot phase will~     allow us to identify the difference that can be expected between the index values and the~     variability of this difference. Based on these values we will be able to determine the size~     of the sample allowing us to statistically test the non-inferiority, or even the superiority~     of this new device. The number of cases to be included during the pilot phase should be at~     least ten cases and a maximum of thirty cases. The choice of the number of cases to be~     integrated during this pilot phase will depend on the homogeneity of the differences obtained~     on the first cases. These values will allow us to calculate the size of the samples necessary~     for the study of non-inferiority as well as for the study of superiority. Depending on the~     calculated sizes samples we will make a choice to ensure that this study takes place in the~     expected duration.~   "
3518|NCT03520816|"~     Background: This study planned to investigate the effect of early physiotherapy on~     biochemical parameters in major burn patients.~      Methods: Ten women (50%) and 10 men (50%) aged 21-47 years old were included in our study.~     Participants were divided into two groups: one group was the treatment group and the other~     was the control group. In the treatment group, patients were admitted to the physiotherapy~     programme from the first day they have been hospitalised, in addition to their routine~     treatment (medical, surgery, etc.), for 4 days per week. It consisted of parameters such as~     early mobilisation and ambulatory training, chest physiotherapy, and both active and passive~     normal joint movement exercises. The days of treatment were determined as Tuesday, Wednesday,~     Thursday and Friday. Patients could not be treated on a Monday because that was surgery day.~     The control group consisted of patients who could not receive physiotherapy due to various~     reasons. All patients included in the study were evaluated weekly for 6 weeks after admission~     to the hospital. Parameters such as demographic information, characteristics of burn injury,~     C-reactive protein, fibronectin, transferrin and prealbumin were evaluated.~   "
3519|NCT03520803|"~     While laparoscopic sleeve gastrectomy (LSG) has become the most commonly performed bariatric~     surgery procedure in the US and worldwide, it is associated with significant postoperative~     nausea and vomiting (PONV), which can lead to patient readmission for rehydration and symptom~     control. Enhanced recovery after surgery (ERAS) is an approach that aligns the practice of~     anesthesia with the care given by the surgical team before, during, and after surgery. A~     number of prospective series, retrospective analyses and one randomized clinical trial of~     ERAS use in bariatric patients support the idea that ERAS in this population is feasible,~     effective and safe and that it is associated with shorter lengths of stay, fewer readmissions~     and decreased costs. In this protocol, the investigators will conduct a prospective,~     randomized control study using a structured and integrative perioperative plan (ERAS; n = 64)~     vs. current standard of care (SOC; n = 64) for patients undergoing LSG at Hartford Hospital.~     The investigators are guided by the idea that an enhanced recovery protocol can potentially~     serve to enhance the early patient experience and set the stage for a more rapid transition~     out of the recovery phase and into the weight loss phase of the patient's care. The~     investigators will incorporate a postoperative multidrug strategy targeting multiple~     receptors to decrease PONV and pain, similar to ERAS Society recommendations for bariatric~     patients.~      Specific Aims and Hypotheses The central hypothesis is that the introduction of an ERAS~     pathway in patients undergoing LSG is feasible and will lead to better clinical outcomes.~      Aim 1. To evaluate the effect that introducing an ERAS pathway will have on the use of~     narcotic medication for the management of postoperative pain, PONV, readiness for discharge,~     and overall length of stay in patients undergoing LSG.~      Aim 2. To evaluate the safety of the ERAS protocol by measuring inpatient and 30-day adverse~     events, emergency department (ED) visits, outpatient hydration, readmission rates and~     delirium.~      Participants will be recruited through fliers posted at Surgical Weight Loss Center locations~     (Glastonbury, Enfield, Hartford, Farmington, Manchester and South Windsor).~   "
3520|NCT03520790|"~     This research study is a two stage study which consists of a safety run-in phase and a~     randomized phase 2 study which include subjects with previously-untreated, metastatic~     pancreatic adenocarcinoma. In the run-in safety study, the safety of adding two formulations~     (IV or Oral) of paricalcitol to a standard chemotherapy program of gemcitabine and~     nab-paclitaxel will be evaluated. The randomized phase 2 study will evaluate the efficacy of~     paricalcitol when added to gemcitabine and nab-paclitaxel~      The drugs involved in this study are:~        -  Paricalcitol~        -  Gemcitabine~        -  Nab-paclitaxel~   "
3522|NCT03520764|"~     This study investigates the effects of a new infant formula on growth, safety, and tolerance~     in healthy term Chinese infants.~      Screening starts after the informed consent is obtained. Infants who are less than or equal~     to 28 days of age and meeting all eligibility criteria will be enrolled into the study. The~     total duration of the study is around 12 months which includes 8 study visits.~      Infants, whose mother has the intention to fully breastfeed her infant at least until 17~     weeks of age will be enrolled into the breastfeeding reference group. Infants, whose mother~     has the intention to fully formula feed her infant as of 28 days of age at the latest, will~     be randomized to receive either the investigational product or control product until infants~     reach the age of 17 weeks. After the age of 17 weeks, infants can switch to any feeding and~     continue be followed up until 12 months of age.~      Safety, growth and tolerance parameters will be followed and collected throughout the study.~   "
3523|NCT03520751|"~     This clinical trial is an open-label, one-time injection ascending dose study in which~     scAAV1.tMCK.NTF3 will be administered by intramuscular injections into muscles in both legs~     in CMT1A subjects with PMP22 gene duplication. Cohort 1 will include three subjects ages 18~     to 35 years receiving (2e12 vg/kg), and Cohort 2 will include six subjects ages 15 to 35~     years old receiving (6e12 vg/kg).~   "
3524|NCT03520738|"~     Vascular calcification is a common finding in chronic kidney disease and increases arterial~     stiffness leading to augmented cardiovascular morbidity. The calcification process is~     thoroughly regulated by pro and anticalcifying agents. The investigators hypothesize that~     imbalance in these compounds could depend on alkaline phosphatase activity. Therefore, the~     investigators will measure ALP activity, calcifications score, arterial stiffness and perform~     a bio-collection in monogenic rare diseases characterized by various levels of anticalcifying~     agents and in diverse CKD stages characterized by various levels of procalcifying compounds.~   "
3525|NCT03520725|"~     The objective of the present study was to evaluate the impact of a snack bar on some health~     indicators associated with diet (plasma antioxidant capacity, lipid profile, vitamin A~     profile (retinol and carotenoids)) and on the nutritional status (impact on energy and~     nutrients consumed) in a group of upper level students.~   "
3526|NCT03520712|"~     This study is being conducted by Biomarin Pharmaceutical Inc. as an open label, single dose~     study in order to determine the safety of valoctocogene roxaparvovec (an~     Adenovirus-Associated Virus (AAV) based gene therapy vector in participants with severe~     Haemophilia A who also have pre-existing antibodies against AAV5.~   "
3527|NCT03520699|"~     Metabolic surgery, as a recognition treatment option for patients with clinical morbid~     obesity, is gaining increasing appreciation. In addition to substantial weight loss, emerging~     studies have highlighted that metabolic surgery can substantially ameliorate obesity-related~     metabolic diseases, including but not limited to type 2 diabetes mellitus (T2DM),~     hypertension, dyslipidemia, obstructive sleep apnea-hypopnea syndrome (OSAHS) and polycystic~     ovary syndrome (PCOS)in severely obese patients. However, further investigations with larger~     sample size and longer observation time still needed to clarity the efficacy and safety of~     metabolic surgery in Chinese patients with obesity and encouraging future research in this~     field.~   "
3528|NCT03520686|"~     This is a phase 2, open-label, randomized study to compare the safety and efficacy of~     combination therapy with ALT-803 and pembrolizumab (experimental arm) versus pembrolizumab~     alone (control arm), as first-line treatment for subjects with metastatic NSCLC in which~     pembrolizumab is indicated for first-line treatment.~   "
3529|NCT03520673|"~     The PriMUS Study aims to develop a clinical decision support tool to help GPs more accurately~     diagnose and manage LUTS in men. The study will recruit 880 men across three research hubs in~     Bristol, Newcastle and Wales. Men will all receive a series of simple index tests in primary~     care (following NICE Clinical Guidelines) and a urodynamics reference test. The study will~     then compare which combination of the simple index tests give the best prediction of the~     urodynamics result, which can then be incorporated into the clinical decision support tool.~   "
3530|NCT03520660|"~     Background:~      Chronic hepatitis C infects the liver. It may scar the liver. This is called cirrhosis and~     may lead to liver cancer or death. Current chronic hepatitis C treatments cure most people.~     But some keep getting complications even after it is cured. Researchers want to study why.~      Objective:~      To study the course and complications of liver disease after cure of hepatitis C infection.~      Eligibility:~      Adults 18 years and older infected with chronic hepatitis C virus who were never treated or~     were treated and not cured and those who were cured~      Design:~      Participants will be screened with:~      Blood and urine tests~      Questionnaires~      Liver ultrasound~      Fibroscan. A probe vibrates the liver, testing stiffness.~      In Phase 1, people with chronic hepatitis C will:~      Have a 3-day clinic stay to repeat some screening tests and have a liver biopsy. A small~     piece of liver is removed by needle passed through the skin.~      Take 1 tablet containing 2 hepatitis C drugs once a day for 12 weeks.~      Repeat some screening tests at 3 visits in those 12 weeks, then 4 visits in the next 24~     weeks.~      Phase 1 participants who test negative for hepatitis C and all other participants will enter~     Phase 2.~      Phase 2 participants will have a visit every 24 weeks for 10 years. These may include:~      Repeats of screening tests~      Scans~      Stool tests~      Chest x-ray~      Heart function test~      Endoscopy. A tube guides a camera into the upper digestive system.~      At about 5 years, participants will have another liver biopsy.~      Some participants will give separate consent for genetic testing and a special blood~     procedure.~   "
3545|NCT03520465|"~     Randomized prospective experimental study, in which the effect of a prophylactic mesh is~     assessed in the eventration rate diagnosed by CT at one year after surgery in patients with~     CRC who underwent elective intervention for supra-infraumbilical midline laparotomy,~     considering as treatment the supra-aponeurotic mesh positioning (experimental group), and~     comparing it to the standard closing with a continuous suture using slow absorption~     monofilament.~   "
3546|NCT03520452|"~     This study evaluates effects of different doses of chlorogenic acids on vascular health.~   "
3559|NCT03520283|"~     This pilot trial studies how well systems support mapping works in guiding self-management in~     stage I-III colorectal cancer survivors. Systems support mapping helps participants to see~     complex self-management activities on paper, which makes them more actionable. Behavioral~     interventions, such as systems support mapping, may help colorectal cancer survivors~     facilitate self-awareness, create motivation for behavior change, and guide self-management.~   "
3531|NCT03520647|"~     Background:~      Severe aplastic anemia (SAA) and myelodysplastic syndrome (MD) cause serious blood problems.~     Stem cell transplants using bone marrow or blood plus chemotherapy can help. Researchers want~     to see if using peripheral blood stem cells (PBSCs) rather than bone marrow cells works too.~     PBSCs are easier to collect and have more cells that help transplants.~      Objectives:~      To see how safely and effectively SAA and MD are treated using peripheral blood hematopoietic~     stem cells from a family member plus chemotherapy.~      Eligibility:~      Recipients ages 4 55 with SAA or MD and their relative donors ages 4 75~      Design:~      Recipients will have:~        -  Blood, urine, heart, and lung tests~        -  Scans~        -  Bone marrow sample~      Recipients will need a caregiver for several months. They may make fertility plans and a~     power of attorney.~      Donors will have blood and tissue tests, then injections to boost stem cells for 5 7 days.~      Donors will have blood collected from a tube in an arm or leg vein. A machine will separate~     stem cells and maybe white blood cells. The rest of the blood will be returned into the other~     arm or leg.~      In the hospital for about 1 month, recipients will have:~        -  Central line inserted in the neck or chest~        -  Medicines for side effects~        -  Chemotherapy over 8 days and radiation 1 time~        -  Stem cell transplant over 4 hours~      Up to 6 months after transplant, recipients will stay near NIH for weekly physical exams and~     blood tests.~      At day 180, recipients will go home. They will have tests at their doctor s office and NIH~     several times over 5 years.~   "
3532|NCT03520634|"~     This is a feasibility study for the use of [18F]PD-L1 as a PET tracer that will be conducted~     in a single center. The study consists of two phases. The aim of phase one is to provide~     pharmacokinetic information on the tracer and to determine the optimal time point for~     imaging. In the second phase the main study objective will be assessed.~   "
3533|NCT03520621|"~     This observational cross-sectional study is investigating if young children in populations~     with higher prevalence of kwashiorkor malnutrition have lower dietary sulfur amino acid~     intake than populations with lower prevalence of kwashiorkor, controlling for multiple~     potential confounding factors. Intake is estimated through diet recalls during interviews~     with a child's caregiver, analysis of urine samples and analysis of food samples for their~     amino acid profiles.~   "
3534|NCT03520608|"~     Painful Diabetic peripheral Neuropathy Study of Chinese OutPatiEnt (PDN-SCOPE): a~     multi-center cross-sectional registry study of clinical characteristics and treatment survey~     of PDN in China~   "
3535|NCT03520595|"~     Introduction:~      Homeopathy is a deep healing, comprehensive and distinct system originally developed by~     Samuel Hahnemann about 200 years ago. Small doses of specially prepared (potentized)~     remedies which set the body's systems back in order and stimulate a body's own energies~     toward a natural healing process. It is entirely distinct in both theory and in practice from~     other healing systems from ordinary or main-stream (allopathic) medicine, but also from~     acupuncture, naturopathy, chiropractics, etc., although some homeopathy often finds its way~     into these other fields of practice.Homeopathy is based on the concept similia similibus~     curentur which means symptoms, caused by the original substance in healthy subjects, can be~     reversed by the homeopathic remedy in patients having similar symptoms.Homeopathy has the~     advantages such as it is inexpensive (the only expense is the homeopath's time and training -~     the remedies themselves cost practically nothing), non-toxic (although side affects which~     reflect the body's own healing processes may occur - such as fever, discharge, rash, etc.)~     and non-intrusive (the remedies are carried on tiny sugar granules which are dissolved in~     water or in the mouth, or swallowed).Arnica is one of the most popular medications in~     homeopathy medicine. This remedy can be extracted from several plant species belonging to the~     Aesteraceae family including Arnica montana, Arnica fulgens, Arnica cordifolia, Arnica~     chamissonis and Arnica sororia, and it is widely sold as tincture, ointment, cream, gel, and~     tablet. It has been used for the treatment of numerous pathological conditions, including~     pain, swelling and stiffness associated with trauma, contusions, sprains, myocarditis, angina~     pectoris, cardiac insufficiency, arteriosclerosis, postoperative clinical conditions, and for~     symptomatic relief in osteoarthritis.Conventional NSAIDs work by inhibiting cyclooxygenase~     (COX) and prostaglandin synthesis as well as by other less understood mechanisms. Onset of~     analgesia occurs rapidly with all NSAIDs, usually within one hour.Diclofenac is one of~     potent, standard and most unique NSAID for the therapy of postoperative pain. Diclofenac~     inhibits the lipoxygenase pathways, which reduces the formation of the leukotrienes (also~     pro-inflammatory autacoids) and also inhibit phospholipase A2. These actions explain the high~     potency of diclofenac.NSAIDs cause a variety of side effects including nausea, diarrhea,~     constipation, dizziness, headache, confusion, edema, rash, and pruritis. They can also cause~     more serious toxicities such as gastrointestinal (GI) ulceration/bleeding, hematologic~     disturbances, bronchospasm, angioedema, renal dysfunction, and hepatotoxicity. Many of these~     side effects are due to NSAID inhibiting prostaglandin synthesis other than at the desired~     site of action.Arnica being clinical efficient and high tolerable makes it a potential~     therapeutic alternative target to non-steroidal anti-inflammatory drugs.In this study~     investigator will compare and evaluate the efficacy of Arnica as a substitute for analgesics~     such as Diclofenac Sodium, through which side effects of NSAIDS can be avoided and get the~     same analgesia effect through Arnica without any of the undesirable effects for minor~     surgical procedures.~      AIM:~      To compare and evaluate the analgesic effect of Arnica Montana with Diclofenac sodium after~     crown lengthening procedure with ostectomy.~      Objectives:~      To assess the analgesic effect on crown lengthening procedure with ostectomy patients of~     Arnica Montana and Diclofenac Sodium.~   "
3536|NCT03520582|"~     The aim of this study is to evaluate the technical feasibility of the new tube placement~     technology in healthy volunteers and, if proven feasible, in critically ill patients~     requiring placement of a feeding tube.~   "
3537|NCT03520569|"~     The investigators are studying the effects of Hyperglycemia on vascular function and insulin~     sensitivity on healthy adults~   "
3538|NCT03520556|"~     According to the World Health Organization, cardiovascular diseases (CVDs) are the number 1~     cause of death globally. Systemic and local tissue inflammation is now recognized as a key~     etiological process leading to CVD. Hence, elevated blood levels of inflammation markers are~     classified among the well-established risk factors for the development of CVD. Among~     nutritional strategies to prevent and/or reduce chronic inflammation, long-chain omega 3 PUFA~     (LCn-3PUFA), notably eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), have raised~     tremendous interest for their purported anti-inflammatory effects. Previous meta-analysis of~     randomized controlled trials (RCTs) substantiated the anti-inflammatory effect of LCn-3PUFA~     supplementation as evidenced by significant reductions in plasma concentrations of specific~     inflammation markers such as C-reactive protein (CRP) and tumor necrosis factor alpha~     (TNF-alpha). However, it is stressed that almost all of the reported RCTs have used a mix of~     EPA and DHA in various ratios, as EPA and DHA occur concomitantly and naturally in food (fish~     oils) and in most dietary supplements. Yet, several recent RCTs have recently been undertaken~     to test the hypothesis that not all LCn-3PUFAs are equal, at least when it comes to their~     anti-inflammatory effects. Accordingly, there is increasing interest and evidence for~     potential distinctive effects of DHA compared to EPA on systemic inflammation, raising the~     question: Is DHA a more potent anti-inflammatory nutrient than EPA? To formally answer this~     question, we will conduct a systematic review and meta-analysis of RCTs to assess and compare~     the individual anti-inflammatory effects of DHA and of EPA. The present work will be a~     pairwise and network meta-analysis focusing on RCTs comparing the effects of EPA and DHA on~     surrogate markers of systemic inflammation. The findings generated by these analyses will~     provide invaluable and timely comparative information on the specific efficacy of DHA and EPA~     as one of the key nutritional modalities for the treatment of chronic inflammation in~     high-risk men and women. This is important considering that LCn-3PUFA supplements are~     increasingly being used by the population and an ever growing market in the dietary~     supplements' industry.~   "
3539|NCT03520543|"~     The main purpose of this study is to model tissue specific kinetics of [11C]Yohimbine in~     healthy male participants by positron emission tomography (PET) and the appropriate arterial~     input function (part A) ; to determine the reproducibility of measures (classical test-retest~     study, part B1) and to measure the blocking of [11C]Yohimbine uptake in the brain following~     single oral dose administration of clonidine (part B2).~   "
3540|NCT03520530|"~     Shortening the second stage of labor, the time spent pushing the baby out, is important for~     positive mother and infant's outcomes. Lack of progress of labor for any reason is the most~     common reason for cesarean section in women having their first baby and the second most~     common reason for cesarean section in women who have already had a baby. In 2014, a large~     study done across the United States showed increases in complications in both mother and~     infant when pushing was prolonged, including uterine infection, postpartum hemorrhage, more~     extensive vaginal tearing, shoulder dystocia, 5 minute Apgar score less than 4, infant~     admission to Neonatal Intensive Care Unit and neonatal infections. Therefore, the challenge~     is to consider alternative practices in order to maximize a mother's chance of a vaginal~     delivery and minimize these associated risks to both mother and baby.~      Mouth guards are used primarily in contact sports, and have been demonstrated to reduce or~     prevent injury to the teeth. Additionally, it has been proposed that wearing a mouth guard~     increases the strength of different muscle groups. A recent randomized controlled pilot study~     including women with their first pregnancy using a dental support device (DSD) during the~     second stage of labor evaluated the length of the second stage and outcomes. They found a~     significant decrease of 38% in the length of pushing time in the group that used a DSD.~     Additionally, there was a decreased rate of cesarean section in this group, however a p-value~     was not reported. This study only included 64 patients. A second, larger trial did not find a~     significant difference in pushing time, however the rate of interventions such as a vacuum or~     forceps-assisted vaginal delivery and cesarean section were much higher in the control group~     due to prolonged pushing. The results of the second study are contradictory in nature, yet~     the researchers do not provide hypotheses into why this may be.~      It is clear from the previously mentioned studies that further research is needed. Our~     hypothesis is that using such a device would help women to push more effectively during the~     second stage of labor thus shortening the time needed to push the baby out and increasing the~     rate of vaginal delivery. The purpose of this study is to determine whether wearing a mouth~     guard in the second stage of labor affects the length of the second stage of labor and~     improves mother & infant outcomes.~   "
3541|NCT03520517|"~     Phase 1, open-label study of BHV-0223 in ALS.~   "
3542|NCT03520504|"~     The purpose of this study is to find the safest and most effective dose for delivering proton~     beam to the space containing CSF, brain, and spinal cord, in treating leptomeningeal~     metastases. The researchers think that using proton beam radiation to treat the space~     containing CSF, brain, and spinal cord, instead of treating only the areas where the~     metastasized tumor cells are causing symptoms, would improve the treatment of this disease.~   "
3547|NCT03520439|"~     This clinical trial is designed to study the effectiveness and safety of mifepristone in the~     treatment of symptomatic adenomyosis with multi center, random, double blind and controlled~     clinical trials. This multicenter study is performed in 150 subjects who are diagnosed as~     adenomyosis . Twelve weeks of randomization, allocation concealment, double-blind,~     placebo-controlled, parallel grouping. Subjects are randomly assigned to one of two treatment~     groups and received one of the following treatments:~        1. Mifepristone tablets of 10mg, 1 tablet daily, oral~        2. Placebo, 1 tablet daily, oral~   "
3548|NCT03520426|"~     This is a multi-site, randomized, prospective study designed to evaluate the safety and~     efficacy of the Votiva device headpieces through radiofrequency for vaginal rejuvenation. An~     anticipated 50 subjects will undergo 3 treatments of the vulvovaginal area using~     radiofrequency unit or radiofrequency placebo. Study duration for each subject is~     approximately six months (including screening, 3 treatment sessions 3-4 weeks apart and 2~     follow-up visit at 3 and 6 months post initiation of treatment (4 and 12 weeks after~     completion of last treatment). Efficacy will be measured and evaluated by validated~     questionnaires to include: The Vulvovaginal Symptoms Questionnaire, Vaginal Laxity~     Questionnaire (VLQ), Urogenital Distress Short Form (UDI-6) and Incontinence Impact~     Questionnaire Short Form (IIQ-7), Female Sexual Function Index (FSFI) and the Female Sexual~     Distress Scale-Revised (FSDS-R).~   "
3549|NCT03520413|"~     Diabetes generates significant morbidity, mortality, and costs within the Veterans Health~     Administration (VHA). Veterans with persistently poor diabetes control despite clinic-based~     care are among the highest-risk diabetes patients in VHA, and contribute disproportionately~     to VHA's massive burden of diabetes complications and costs. VHA critically needs effective,~     practical management alternatives for Veterans whose diabetes does not respond to~     clinic-based management. The proposed study will address this need by leveraging VHA's unique~     Home Telehealth capacity to deliver comprehensive telemedicine-based management for Veterans~     with persistently poor diabetes control despite clinic-based care. Because this intensive~     intervention is delivered using only existing Home Telehealth workforce, infrastructure, and~     technical resources - which are ubiquitous at VHA centers nationwide - it could represent an~     effective, practical approach to improving outcomes in Veterans with PPDM, potentially~     translating to a substantial reduction in VHA's diabetes burden.~   "
3550|NCT03520400|"~     Cardiovascular disease remains the leading cause of morbidity and mortality in the U.S. and~     is a major cause of disability in Veterans. Most of these deaths are due to coronary artery~     disease (CAD). The most common treatment for CAD is revascularization, an invasive procedure~     which usually involves placing a stent inside an artery that is diseased. However, exercise~     training is often overlooked because clinicians tend to focus on repairing the coronary~     circulation and the potential need for revascularization. Studies have shown that exercise~     training can be effective for patients with CAD and that it saves costs. In this study,~     invasive revascularization will be compared to a structured program of exercise training over~     one year. Comparisons will be made between groups for symptoms, coronary artery size and~     function using PET/CTA, and health care cost utilization.~   "
3551|NCT03520387|"~     Back pain is the #1 contributor to disability in the United States (US), and second only to~     hearing problems as a reason for new Veteran disability compensation. The societal burden of~     back pain is driven mainly by chronic low back pain (CLBP), defined as low back pain~     persisting for 3 months. Since most individual treatments for CLBP have only small effects on~     functional recovery, combining CLBP treatments has recently been recommended as a priority~     area for research. However, few prior studies of CLBP have been properly designed to evaluate~     the effects of treatment combinations. Large effects on functional recovery from CLBP may~     require combining interventions that each target different points on a theoretical pathway to~     functional recovery. Procedural treatments for CLBP aim primarily to address early stages in~     the pathway to functional recovery, such as problems with the lumbar spinal structures or low~     back pain itself. In contrast, behavioral interventions for CLBP generally have effects not~     only on pain itself, but also work by mitigating the degree to which the sensation of low~     back pain impacts function, well-being, and quality of life. These represent later stages in~     the pathway to functional recovery from CLBP. Combining procedural and behavioral treatments~     may have great potential for achieving large magnitude treatment effects for CLBP in~     Veterans.~      The proposed research uses an innovative application of the 2 x 2 factorial randomized~     controlled trial (RCT) design to examine the individual and combined effects of 1) lumbar~     medial branch nerve radiofrequency ablation (LRFA), a commonly used procedural intervention~     to target low back pain severity, and 2) a novel video telehealth tablet- and personal~     computer (PC)-based Activity Tracker-Informed Video-Enabled Cognitive Behavioral Therapy~     program (AcTIVE-CBT), a behavioral intervention designed primarily to target functional~     limitations both secondary to, and independent of, improvements in pain. The LRFA treatment~     to be used in the proposed study addresses the major patient selection, procedural/technical,~     methodologic and reporting limitations of prior studies. AcTIVE-CBT addresses problems with~     Veteran access and compliance associated with conventional cognitive behavioral therapy (CBT)~     delivered in clinic, and uses currently available activity tracking technology to better~     promote activity and behavior change as compared to conventional CBT. This pilot RCT involves~     recruitment of up to 30 Veterans with CLBP who will be followed to evaluate functional~     recovery for up to 3 months, to reach a goal of 20 Veterans completing the 3-month primary~     outcome. The primary outcome is participant-reported back-related functional limitations~     (mobility and ADLs) at 3 months, as measured by the validated Roland-Morris Disability~     Questionnaire. Secondary outcomes include activity tracker-assessed step counts, back pain~     intensity, reduction in opioid use, and quality of life. The investigators hypothesize that~     1) each individual treatment will result in improvements in back-related functional~     limitations and secondary outcomes compared to control, and 2) combined treatment will~     produce greater treatment effects than each of the individual treatments alone. Although both~     the LRFA and AcTIVE-CBT treatment arms are innovations on their own, the most unique aspect~     of the proposed study is the use of the factorial RCT design to examine whether 'stacking'~     disparate CLBP treatments can result in greater treatment effects than that of each treatment~     alone. Although the proposed pilot study is unlikely to definitively address whether these~     treatments alone or in combination have significant effects on functional recovery, it will~     produce valid effect size estimates that will inform a future large-scale multicenter RCT~     (likely funded by a programmatic or cooperative grant mechanism) to determine the efficacy of~     LRFA, AcTIVE-CBT, or combined LRFA + AcTIVE-CBT, for Veterans with CLBP.~   "
3552|NCT03520374|"~     Perioperative aspiration of gastric contents is a rare but serious adverse event. The risk of~     aspiration can be estimated by perioperative evaluation of stomach contents with ultrasound~     using a validated technique and scoring system. A lack of knowledge or familiarity is~     frequently cited by anesthesia providers as a rationale for not performing perioperative~     ultrasound assessments. The purpose of this study is to determine whether novice~     ultrasonography users (medical students or undergraduates) can be effectively taught a~     technique to evaluate stomach contents as compared to experts in ultrasonography.~   "
3553|NCT03520361|"~     For evaluation of the usefulness of oral sulfate solution (OSS) for bowel preparation of~     elderly people, investigators compare the efficacy, tolerability and safety between OSS and~     2L polyethylene glycol (PEG) with ascorbic acid (Asc).~   "
3554|NCT03520348|"~     Title of the study:~      Phase I clinical trial, to evaluate the safety and tolerability of the ophthalmic gel PRO-167~     versus Corneregel®, on the ocular surface of ophthalmological and clinically healthy~     subjects.~      Methodology:~      Phase I clinical trial, controlled, of parallel groups, double blind, randomized,~     exploratory.~      Goals:~      To evaluate the safety and tolerability of the ophthalmic gel PRO-167 manufactured by~     Laboratorios Sophia S.A. of C.V. on the ocular surface of clinically healthy subjects.~      Hypothesis:~      Ophthalmic gel PRO-167 has a safety and tolerability profile similar to that of its~     comparator in healthy subjects.~   "
3555|NCT03520335|"~     The investigators have developed a simple prehospital stroke scale (FPSS), containing 5~     dichotomized items to recognize both large and small artery thrombi of the brain. FPSS is~     implemented to both emergency medical services and later, to emergency response centers. The~     efficacy of the scale and possible improvement of both the patient flow and treatment results~     will be evaluated.~   "
3556|NCT03520322|"~     The purpose of this study is to investigate the efficacy of a mastoid treatment device in~     patients with active Ménière's disease that is not controlled by traditional medical~     management~   "
3557|NCT03520309|"~     There is still great divergence in the aspects related to caries lesions around restorations.~     The methods and the systems used for the detection of secondary caries lesions have presented~     low validity. Also, the consequent treatment decisions of this kind of lesions have presented~     a lot of variation. However, the correct diagnosis of secondary caries may guarantee greater~     longevity to the restorative treatment, as well as oral health to the patients, reducing the~     cost and clinical time of the dentists. Therefore, the investigators aimed to perform this~     study to evaluate and compare two visual criteria for the evaluation of restorations in~     primary teeth in medium and long term outcomes for the patients, through a randomized~     clinical study. These criteria are the system proposed by the World Dental Federation (FDI)~     and the International Caries Classification and Management System - ICCMS.~   "
3558|NCT03520296|"~     The aim of this study is to qualify patient well-being in relation to diet. The notion of~     dietary well-being is believed to be subjective and we wish to base it on tangible parameters~     (presentation of meals, variety of menus, social interaction, environment, convenience,~     pleasure...) in order to establish a score of dietary well-being that we will then correlate~     to the patient's nutritional status. This tool can then be used more widely as an assessment~     tool within health institutions.~   "
3561|NCT03520257|"~     This study uses to suppress the growth of tumors, extend the patient's survival time and~     improve the quality of life as much as possible. Through the treatment, the patient is given~     the chance to undergo surgical resection, thereby more effectively prolonging the OS.~     Apatinib is a small-molecule VEGFR tyrosine kinase inhibitor. It mainly treats malignant~     tumors by inhibiting VEGFR and exerting anti-angiogenic effects. Preclinical studies have~     shown that its anti-tumor effect is better than that of the similar drug PTK787. Phase II~     studies of hepatocellular carcinoma have initially demonstrated the effectiveness and safety~     of apatinib in the treatment of advanced HCC. Radiotherapy of tumors and portal vein tumor~     thrombi can promote further tumor shrinkage, and at the same time, the physiological basis~     for the recanalization of the original tumor thrombus itself will result in necrosis and~     fibrosis of the tumor thrombus, completely blocking the blood supply to the tumor portal~     vein. As a result, blood supply to the other side of the portal vein increases, and~     hepatocyte regeneration in a healthy liver is promoted, so that the patient can obtain~     surgical opportunities. Based on the therapeutic potential of apatinib and radiotherapy, we~     designed a prospective exploratory clinical study of this patient with advanced liver cancer.~   "
3562|NCT03520244|"~     Engagement in regular physical activity (PA) is associated with a range of physical and~     psychological benefits among chronic disease populations. Celiac disease is a chronic~     autoimmune condition that requires strict adherence to a gluten-free diet (GFD) for the best~     medical outcomes, as well as to prevent detrimental health outcomes including bloating,~     diarrhea, constipation, and increased risk of intestinal cancers and osteoporosis. Despite~     following a GFD, individuals with celiac disease often report dissatisfaction with the diet,~     are less likely to engage in social activities, can have an imbalance in gut bacteria and up~     to 30% still report negative symptoms (e.g., gastro-intestinal upset). Furthermore,~     preliminary research revealed that rates of PA among those with celiac disease are dismal,~     with the majority of participants failing to engage in regular PA. The purpose of this pilot~     research project is to examine the effects of a 12-week structured exercise program on~     inactive adults with celiac disease. It is anticipated that compared to those in a wait-list~     control condition, participants who engage in the 12-week exercise program will report~     greater improvements in quality of life and experience improved balance of gut bacteria. The~     findings from this project may reveal an additional strategy to optimize health while living~     with celiac disease. In addition, results from this study will provide essential pilot data~     that will inform a grant application for a larger clinical trial to further investigate the~     role of exercise in the promotion of health and well-being among those with celiac disease.~   "
3563|NCT03520231|"~     This is a phase 2 study of the drug denosumab for the management bone metastases from~     urothelial cancer.~      The purpose of this study is to find out how effective denosumab is in the management of bone~     metastases from urothelial cancer. This will be done by comparing denosumab with standard~     treatment, compared to placebo and standard treatment.~      Denosumab is a monoclonal antibody that binds to a protein called Receptor Activator of~     Nuclear Factor κB (RANK). RANK works by telling certain cells called osteoclasts to break~     down bone tissue. The binding of denosumab to RANK stops it from telling osteoclasts to break~     down bone tissue which may help with symptoms related bone metastases from urothelial cancer.~   "
3564|NCT03520218|"~     The goal of this pilot project is to test the new Radialis Positron Emission Mammography~     (R-PEM) system in breast cancer patients that has a higher sensitivity with lower radiation~     doses than conventional PET/CT.~      The plan for the pilot study is to image patients who are already scheduled for diagnostic~     imaging for breast cancer after a positive core biopsy. Participants will be injected with~     5mCi of F-18 FDG and patient will wait for a couple of hours for uptake of FDG. After this~     time, the first R-PEM scan will occur. Additional optional R-PEM scans can be performed 4~     hours after injection and 7 hours after injection with reductions in radiation emission.~      Additionally, R-PEM images will be compared to standard-of-care breast MRI and digital breast~     tomosynthesis to study extension of disease and screening of contralateral breast.~   "
3565|NCT03520205|"~     This study aimed to compare Quadratus Lumborum Block to Epidural on Stress Response and~     Perioperative Cellular Immunological Function of Laparoscopic Nephrectomy Kidney Donor~   "
3566|NCT03520192|"~     There are fewer than 30 paediatric intensive care units (PICUs) in the United Kingdom (UK).~     This means that a critically ill child taken to their nearest hospital will need to be~     transferred to a PICU. Such transports are usually done by PICU retrieval teams (PICRTs),~     mobile teams who take specialist expertise to the child and safely transport them to a PICU.~      There are national variations in how PICRTs are organised and deliver clinical care. There~     has been little research into these differences and how they might influence outcomes and~     experiences for sick children and families. The investigators do not know if national~     variation in how PICRT services are organised and delivered matters, or whether current~     standards help achieve the best outcomes for patients. This clinical study aims to understand~     how existing differences in access to paediatric intensive care and care provided by PICRTs~     affect clinical outcomes and experiences for transported critically ill children and~     families. The investigators will analyse routine national audit data to examine various~     aspects such as how long it takes a PICRT to reach the patient, how long it takes the child~     to reach the PICU, the seniority of clinicians performing the transport, medical procedures~     performed by the PICRT and any critical incidents during transport, and investigate whether~     any of these factors influence how likely a child is to survive. The investigators will also~     collect and analyse information about the experiences of sick children by interviewing the~     families involved, and staff experiences of PICU retrieval by interviewing clinicians.~     Alongside this work, the investigators will look at the costs of different ways of delivering~     PICRT services for sick children, and use mathematical techniques to study if and how~     alternate models of service delivery can improve clinical outcomes in a cost effective~     manner. The research team in this trial includes PICU and transport clinicians, parents,~     academic experts and an National Health Service (NHS) commissioner.~      Independent committees consisting of clinicians and parents will be formed to oversee the~     study. The work from this study will directly inform the development of evidence-based~     national standards for PICU transport and help improve the patient experience for critically~     ill children and their families.~   "
3590|NCT03519880|"~     Non-invasive ventilation (NIV) is an important therapy for patients with a number of~     neurological diseases. Specifically, NIV has been shown to be an effective treatment for~     people with amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease), which is~     a fatal, non-curable, progressive disease of the motor neurons. However, due to changes in~     facial structure associated with the disease, many ALS patients find that traditional NIV~     masks don't fit well. In this study, investigators will perform a feasibility study on NIV~     mask interfaces which are custom designed for each ALS patient and then manufactured via 3D~     printing.~   "
3643|NCT03519178|"~     Open-label, multi-center, non-randomized, multiple dose, safety, tolerability,~     pharmacokinetic, and pharmacodynamics and clinical activity study of PF-06873600 administered~     as a single agent and then in combination with endocrine therapy. The study contains two~     parts, a Part 1 single agent dose escalation and combination endocrine therapy dose finding~     component and a Part 2 dose expansion as both a single agent and in combination with~     endocrine therapy.~   "
3567|NCT03520179|"~     The investigators aim is to establish a Spinal Muscular Atrophy (SMA) National Platform to~     improve UK standards of care, manage national and International clinical trials and~     facilitate translational research for this common neuromuscular disease.~      To achieve this purpose investigators will start to systematically collect longitudinal~     validated outcome measures for SMA children followed at GOSH, the largest cohort followed in~     UK, and pilot and update novel outcome measures. This will be done ensuring that data~     collected are not only clinically meaningful but also robust for subsequent use in clinical~     trials.~      In collaboration with the MRC Neuromuscular Centre in London and Newcastle, investigators~     will link the existing registries and the longitudinal data collection of outcome measures~     and develop a hub and bespoke platform model linking the other paediatric UK centres involved~     in the clinical management of SMA patients. This UK SMA Platform (SMA REACH UK) will be a~     unique infrastructure containing the largest comprehensive longitudinal series of SMA patient~     data in the UK; the data collected will be agreed between the relevant other UK centres~     stakeholders and will take into consideration other international initiatives with historical~     success in SMA treatment and research.~      Ongoing analysis including modern psychometric techniques will ensure that the functional~     data collected in the UK SMA population meets the high statistical standards required for the~     data to inform natural history studies and be usable as an outcome measure for clinical~     trials.~      An innovative genetic therapy preclinical project taking advantage of our expertise in~     antisense oligonucleotide compounds will also be pursued on a parallel research project.~   "
3568|NCT03520166|"~     The aim of this study is to assess the effectiveness of medium frequency electrotherapy~     (interferential currents) treatment for overactive bladder (OAB), lower urinary tract~     symptoms (LUTS) and pelvic pain~   "
3569|NCT03520153|"~     The investigators' objective is to understand the pathogenesis of diabetes mellitus in~     Fibrous dysplasia/McCune-Albright syndrome (FD/MAS) by: 1) establishing the contributions of~     insulin resistance versus impaired insulin secretion, 2) investigating presence of excess~     glucagon signaling by measuring gluconeogenesis and glycogenolysis, and 3) investigating a~     potential interaction between diabetes and intraductal papillary mucinous neoplasms (IPMNs).~   "
3570|NCT03520140|"~     Evaluate the prevalence of familial hypercholesterolemia (FH) in patients with documented~     coronary artery disease (CAD) event [acute myocardial infarction (AMI), acute coronary~     syndrome (ACS), coronary artery bypass graft (CABG) or percutaneous coronary intervention~     (PCI)] followed by 100 cardiological centers representative of the whole Italian territory~   "
3571|NCT03520127|"~     The purpose of this registry study is to collect use and clinical outcomes data following~     breast lesion excision or sampling with the Intact BLES.~   "
3572|NCT03520114|"~     One in five women will undergo prolapse surgery in their lifetime, and there is a strong~     correlation between prolapse and urinary incontinence. Pelvic floor surgeons aspire to~     improve relevant quality of life outcomes for women with pelvic floor disorders while~     minimizing complications and unnecessary procedures. There has been an experience of~     disappointment and frustration when a patient returns following POP repair with new symptoms~     of SUI that she ranks as a greater disruption to her quality of life than her original~     vaginal bulge. While retropubic (RP) slings are considered to be the gold-standard referent~     for other slings with long-term outcomes data, they are associated with the highest risks of~     intra- and post-operative complications including bladder injury, bleeding, and~     post-operative voiding dysfunction. Single-incision slings (SIS) are the latest iteration in~     sling development that build upon the benefits of slings but avoid passage through the~     muscles of the inner thigh. The hypothesis for this study is that single-incision slings~     (Altis ™) are non-inferior to Retropubic mid-urethral slings when placed at the time of~     native tissue vaginal repair.~   "
3573|NCT03520101|"~     The treatment with transcatheter aortic valve implantation (TAVI) of patients with small~     (≤23mm) surgical bioprostheses remains a challenge due to the increased transvalvular~     residual gradients and high rates of severe prosthesis-patient mismatch (PPM) following the~     procedure.~   "
3574|NCT03520088|"~     Purpose: The Total Mesorectal Excision (TME) is the standard surgical technique for the~     treatment of rectal cancer. Up to 50% of sexual dysfunction is described after TME and up to~     30% of urinary dysfunction. The main objective of the study is to compare pre- and post-TME~     sexual dysfunction according to the approach of the inferior mesenteric vessels, directly on~     the IMA or from the inferior mesenteric vein (IMV) to the IMA.~      Methods: Multicenter, prospective, controlled and randomized study of patients with rectal~     adenocarcinoma with neoadjuvant chemoradiotherapy, who will be randomized into two groups~     depending on the approach of the inferior mesenteric vessels. The main variable is pre and~     postoperative sexual dysfunction. The sample to be included will be 90 patients, 45 per~     group.~   "
3575|NCT03520075|"~     This study is a first-in-human, open-label, multicenter, Phase 1-2 study to assess the~     safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of ASTX029~     administered orally to subjects with advanced solid malignancies who are not candidates for~     approved or available therapies.~   "
3576|NCT03520062|"~     Glucagon-like peptide-1 (GLP-1) is a gastrointestinal hormone used to treat type 2 diabetes~     and severe overweight (Liraglutide).The two pancreas enzymes: amylase and lipase are slightly~     elevated in GLP-1 treated compared with placebo-treated individuals. Increased levels of~     these two enzymes (amylase and lipase) are associated with acute inflammation of the pancreas~     (acute pancreatitis). In humans treated with GLP-1 (receptor agonist) there have not been~     found an increased risk of acute pancreatitis.~      Animal and cell studies have shown that the increased levels of amylase and lipase in the~     blood are not due to an inflammatory state but adaptive changes (volume increase) of the~     pancreas.~      The investigators (professor Jens Juul Holst, professor Sten Madsbad) want to investigate~     whether the increased levels of amylase and lipase in the blood of individuals treated with~     the GLP-1 analogue Saxenda are due adaptive changes of the pancreas. This will be achieved by~     measuring amylase and lipase before, during and after treatment with a GLP-1 receptor~     agonist, and at the same time use advanced scanning equipment (PET-MR) from the Clinical~     Physiological and Nuclear Medical Department at Rigshospitalet, which can determine any~     volumetric changes in the pancreas with high reproducibility.~      The scan will be centered on the pancreas, other organs are not evaluated why the study is~     not designed to detect any malignant findings in the pancreas or other organs.~   "
3577|NCT03520049|"~     Immune Thrombocytopenia (ITP) is a disorder resulting in impaired platelet production and~     enhanced destruction on the basis of autoantibody-mediated mechanisms. Patients with ITP are~     at increased risk of bleeding and infection. First line therapy includes glucocorticoids,~     with or without the addition of intravenous immune globulin (IVIg) when a prompt platelet~     response is desired. The likelihood of stable and safe disease after first-line treatment~     ranges from 30-60% and risk of relapse requiring additional therapy occurs in 50-80% of~     patients. Moreover, the toxicity associated with first and subsequent therapy for ITP is~     substantial.~      Oseltamivir is an attractive drug for ITP since it specifically targets a pathophysiologic~     mechanism that appears to be important for the development of ITP and has a benign side~     effect profile compared to standard ITP therapy.~      Oseltamivir has never been rigorously tested in humans to determine its efficacy in the~     management of ITP. The investigators therefore propose the first randomized, double blind~     study to assess the impact of oseltamivir on biological markers in adult patients with ITP.~     This study will also provide information about the feasibility of recruitment into a~     definitive trial, which would be coordinated by St. Michael's Hospital.~      The research question is: Do adults (≥ 18 years) with ITP treated with oseltamivir at 75mg~     twice daily for 5 consecutive days have an increase in their mean platelet glycoprotein~     sialylation compared to those receiving placebo?~      This pilot, proof-of-concept, randomized controlled clinical trial will enroll 30 individuals~     with ITP. Randomization and allocation will occur at a ratio of 1:1. Analysis of the primary~     outcome measure will occur via analysis of covariance (ANCOVA).~      This study has the potential to dramatically change the treatment of ITP. If the results from~     this study demonstrate a biological effect, and results from the subsequent definitive study~     are positive, The investigators envision a move away from non-specific immune-blunting~     therapy such as prednisone, towards tailored therapy with oseltamivir. It could diminish the~     lifelong summative immunosuppressive therapy burden, associated drug toxicity and improve~     long- and short-term health outcomes for these patients.~   "
3578|NCT03520036|"~     The purpose of this study is to investigate the efficacy and safety of MT-7117 on sunlight~     exposure duration and tolerance in subjects with EPP.~   "
3579|NCT03520023|"~     Will earlier palliative care medicine consultation in the ICU result in decreased length of~     stay in the ICU and hospital, as well as, increased patient and family satisfaction.~     Secondary questions to be answered is if this early consultation changes ICU and hospital~     death, discharge destinations, hospice admissions, code status changes, and withdrawal of~     life sustaining interventions.~   "
3580|NCT03520010|"~     The Wisconsin Healthcare-Associated Infections in Long-Term Care Coalition has developed a~     toolkit of evidence-based best practices to improve the management of urinary tract infection~     (UTI) in Wisconsin nursing homes (NHs). The theory and evidence supporting the individual~     improvement strategies promoted in the Wisconsin UTI Improvement Toolkit are strong but~     their combined impact on antibiotic prescribing in Wisconsin NHs is not known. Moreover, many~     Wisconsin NHs lack the internal resources and expertise to successfully implement and sustain~     the change interventions recommended in the toolkit. Consequently, there is a critical need~     to identify effective strategies to support implementation of best practices in this setting.~     The investigators hypothesize that an externally-facilitated implementation based on coaching~     and peer-to-peer learning will result in superior toolkit adoption and reduced rates of~     antibiotic utilization compared to a standard implementation.~      To test these two hypotheses, the investigators are proposing a hybrid type 2~     effectiveness-implementation randomized clinical trial in 20 Wisconsin NHs. Facilities~     randomized to the standard implementation approach will participate in a kickoff meeting and~     have access to a variety of online implementation resources. Facilities randomized to the~     enhanced implementation approach will have access to the same resources but will also be~     assigned a clinical coach and be invited to participate in ongoing collaborative learning~     sessions. The clinical coach will meet regularly with NH staff to guide the facility through~     implementation of the toolkit, including assembling a change team, performing an assessment~     to identify baseline barriers and facilitators of change, and ongoing integration of the~     toolkit practices into existing workflows. The learning collaborative will bring NH~     participants together to share change and improvement strategies with each other. UTI~     prescriptions per 1,000 resident-days in the study arms will be compared using generalized~     linear mixed models. A mixed methods evaluation structured around the REAIM framework (Reach,~     Effectiveness, Adoption, Implementation and Maintenance) will be employed to assess~     differences in toolkit implementation among facilities in both arms of the study.~   "
3581|NCT03519997|"~     This is a non-randomized, open-label, multi-site phase II therapeutic trial of pembrolizumab~     and bavituximab in patients with locally advanced HCC. Locally advanced or metastatic HCC is~     defined as disease that is not amenable to surgical and/or locoregional therapies. Subjects~     must not have received prior systemic therapy for advanced HCC in keeping with the first-line~     setting of this study.~   "
3582|NCT03519984|"~     This phase I trial studies the side effects and best dose of recombinant EphB4-HSA fusion~     protein when given together with cytarabine or vincristine liposomal in treating participants~     with acute leukemia that has come back or has not responded to treatment. Drugs used in~     chemotherapy, such as recombinant ephb4-HSA fusion protein, cytarabine, and vincristine~     liposomal, work in different ways to stop the growth of cancer cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Giving the drugs~     in different combinations may kill more cancer cells.~   "
3583|NCT03519971|"~     This is a Phase III, randomized, double-blind, placebo-controlled, multi-center,~     international study assessing the efficacy and safety of durvalumab given concurrently with~     platinum-based CRT (durvalumab + standard of care [SoC] CRT) in patients with locally~     advanced, unresectable NSCLC (Stage III).~   "
3584|NCT03519958|"~     To describe the T790M mutation status of patients with locally advanced/metastatic NSCLC who~     progressed on previous EGFR TKI treatment in a real-world setting.~   "
3585|NCT03519945|"~     This study designed to evaluate the long-term efficacy and safety of mirikizumab in~     participants with moderately to severely active ulcerative colitis (UC).~   "
3586|NCT03519932|"~     The objective of this study is to evaluate the subjective acceptance of comfilcon A toric~     contact lens, compared to samfilcon A toric lens.~   "
3587|NCT03519919|"~     The objective of the study is to evaluate the performance of somofilcon A 1 day multifocal~     when worn on a daily disposable wear modality over a period of up to 3 weeks.~   "
3588|NCT03519906|"~     Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the~     pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the~     pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery.~     Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological~     availability of medication. In this study the pharmacokinetic effects of bariatric surgery on~     metoprolol are investigated.~   "
3589|NCT03519893|"~     Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the~     pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the~     pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery.~     Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological~     availability of medication. In this study the pharmacokinetic effects of bariatric surgery on~     losartan are investigated.~   "
3605|NCT03519685|"~     The purpose of this study is to measure whether a training and education intervention for~     clinic staff and young women aged 18-25 on contraceptive methods, including intrauterine~     devices (IUDs) and the implant, will result in greater contraceptive knowledge and access~     among students in community colleges.~   "
3591|NCT03519867|"~     The primary objective of this study is to explore the dose-response relation of MK-8616 (Org~     25969) given as a reversal agent of Zemuron® at 1 to 2 post tetanic counts (PTCs); both~     Zemuron® and MK-8616 are administered by intravenous (iv) infusion. Another goal of the study~     is to evaluate the safety of single doses of MK-8616 administered in participants of American~     Society of Anesthesiologists (ASA) Physical Status Class 1 (otherwise normal, healthy~     participant); Class 2 (participant with a mild systemic disease); or Class 3 (participant~     with a severe systemic disease that limits activity, but is not incapacitating).~   "
3592|NCT03519854|"~     This study investigates the efficacy, safety, and pharmacokinetics of Org 25969 (MK-8616)~     when administered for the reversal of neuromuscular blockade in male participants receiving~     surgery, classified as American Society of Anesthesiologists (ASA) class 1 (otherwise normal,~     healthy participant) to class 2 (participant with mild systemic disease). The primary~     objective of this study is to explore the dose-response relation of MK-8616 given as a~     reversal agent at 3, 5, or 15 minutes following administration of 0.6 mg/kg Esmeron®.~   "
3593|NCT03519841|"~     This clinical study has been launched to collect spectral Raman data paired with validated~     glucose reference values in private homes of subjects.~   "
3594|NCT03519828|"~     Cognitive impairment after ischemic stroke can affect not only the social adaptation ability,~     but also affect the comprehensive rehabilitation of patients. The damage of cognitive~     impairment after ischemic stroke is not lower than the body function defect after stroke.~     Many studies have shown that oxidative stress is one of the pathophysiological mechanisms of~     ischemic cerebrovascular disease. Many studies have reported that the oxidative-reduction of~     cells plays an important role in the life activities of organisms, affecting the health,~     aging and death of the organism. In the recent years, some scholars have suggested that~     post-stroke cognitive impairment may be related to oxidative-reduction homeostasis of the~     body, but the relevant evidence is lacking and needs to be further explored. Therefore, the~     purpose of this study is to explore the effect of oxidation-reduction homeostasis on~     cognitive impairment in patients with ischemic stroke, and provide a theoretical basis for~     the prevention and treatment of cognitive impairment after ischemic stroke.~   "
3595|NCT03519815|"~     Subjective and objective evaluation of the efficacy and tolerability of preservative-free~     Ectoin® Eye Spray - Colloidal and comparison of the efficacy and tolerability between~     Ectoin® Eye Spray - Colloidal and Tears Again® in patients with mild-moderate dry eye~     disease~   "
3596|NCT03519802|"~     The aftermath of suicide is devastating, being the cause of 800 000 deaths every year~     worldwide. In France, suicide still causes about 10 000 deaths per year and the number of~     suicide attempts (SA) is estimated between 170 000 and 200 000 per year (InVS).~      It is often thought that a suicidal crisis is only related to depression, as it actually is a~     far more complex phenomenon. A suicidal crisis can occur on various grounds like psychiatric~     disorders but also contextual events or somatic diseases and it has been hypothesized that~     suicidal ideas or inclinations could have a common and independent cognitive origin~   "
3597|NCT03519789|"~     Post-traumatic stress disorder (PTSD) is characterized by hypervigilance. In particular,~     previous works suggest that patients tend to scan constantly the environment for possible~     threats. The present project aims at investigating such attentional bias in patients with~     PTSD using the change blindness paradigm that offers the interesting possibility of studying~     sensitivity to sudden changes using ecological stimuli. More precisely, the investigators~     will investigate whether patients are more sensitive than matched controls to sudden changes~     in the visual environment and whether this hypersensitivity is specific or even stronger when~     visual information has an emotional content. The attentional bias will be measured using~     motor responses (accuracy and speed to indicate the occurrence of a change by pressing a~     button) as well as eye movements.~   "
3598|NCT03519776|"~     to examine if a natural daytime variation in progesterone levels may explain parts of the~     inconsistent findings from studies reporting divergent results concerning this matter and~     will be carried out by several blood samples from the same patient during the day of~     ovulation triggering.~   "
3599|NCT03519763|"~     To evaluate the endometrial and isthmic microbiota in patients with isthmocele after~     C-Section, and if this microbiota is similar or not with better reproductive outcomes.~   "
3600|NCT03519750|"~     We will investigate the safety and pharmacokinetics of melatonin, when administered rectally,~     intravesically, vaginally and transdermally. We will recruit 10 healthy female volunteers.~     The volunteers will have melatonin administered over 5 days; intravenously, rectally,~     intravesically, vaginally and transdermally. The participants will be followed for 24-48~     hours with blood samples and questions about adverse events. There will be a wash-out between~     each session of a minimum of 7 days.~   "
3601|NCT03519737|"~     This is a randomized, placebo controlled, double-blind phase 3 clinical study to evaluate the~     efficacy and safety of transcranial ultrasound (TUS) using the Sonolysis Headframe as an~     adjunctive therapy to intravenous (IV) tissue plasminogen activator (tPA) therapy in subjects~     with acute ischemic stroke that initially present at non-endovascular (EVT) treating~     hospitals that have established transport services in place to transfer subjects to hospitals~     capable of performing EVT.~   "
3602|NCT03519724|"~     The primary outcome of this study is to investigate whether deep NMB reversed with Sugammadex~     is superior to moderate NMB reversed with Neostigmine, in terms of overall pain in the first~     48 hrs after laparoscopic gynecologic surgery, reversal time from NMB (TOF≥0.9) and direct~     and indirect costs. Additionally we will also assess: drugs consumption for pain and~     antiemetics (rescue dose), surgical conditions, hemodynamic and respiratory stability,~     operation time, anesthesia time, total amount and flow rate of CO2, insufflation time,~     resolution of post-operative ileus, dry mouth and PONV in the first 48 hours, patient~     satisfaction~   "
3603|NCT03519711|"~     The PBD-001 study has been designed to demonstrate the safety, pharmacokinetics and~     preliminary efficacy of CNSA-001 in reducing blood phenylalanine concentrations in adult and~     adolescent patients with hyperphenylalaninemia due to primary tetrahydrobiopterin (BH4)~     deficiency.~   "
3604|NCT03519698|"~     A randomized, controlled, three-arm study to investigate the effects of footbaths with~     ginger, mustard or warm water alone in female, adolescent patients with Anorexia nervosa and~     in healthy, female adolescents on psychophysiological parameters.~   "
3609|NCT03519633|"~     The primary outcome of this study is to investigate whether deep NMB reversed with Sugammadex~     is superior to moderate NMB reversed with Neostigmine, in terms of overall pain in the first~     48 hrs after laparoscopic gynecologic surgery, reversal time from NMB (TOF≥0.9) and direct~     and indirect costs. Additionally we will also assess: drugs consumption for pain and~     antiemetics (rescue dose), surgical conditions, hemodynamic and respiratory stability,~     operation time, anesthesia time, total amount and flow rate of CO2, insufflation time,~     resolution of post-operative ileus, dry mouth and PONV in the first 48 hours, patient~     satisfaction.~   "
3610|NCT03519620|"~     To study the effects of swimming with water walking in children aged between 6 and 12 years~     in terms of spirometric values.~   "
3611|NCT03519607|"~     The purpose of this study is to determine if the use of a new app, FertiStrong, is associated~     with decreased levels of anxiety and depression in men who have infertility or whose partner~     has infertility.~   "
3612|NCT03519594|"~     Unstable pelvic fracture with bleeding can be fatal, with a mortality rate of up to 40%.~     Therefore, early detection and treatment are important in unstable pelvic trauma. We~     investigated the early predictive factors for possible embolization in patients with~     hemodynamically unstable pelvic trauma. The purpose of this study was to predict the~     necessity of embolization and the timing of angiography using CT scans.~   "
3613|NCT03519581|"~     Diabetic retinopathy is one of the most common complications of diabetes and diabetic macular~     edema (DME) is one of the most common causes of vision loss in diabetes.~      The purpose of this study is to determine if early intervention with micropulse laser~     treatment in eyes with good visual acuity (20/32 or better) will improve or stabilize vision~     loss due to the complications of diabetic macular edema.~   "
3614|NCT03519568|"~     Background: To prevent and control the epidemic of HFMD and related diseases caused by EV71~     infection, the development of EV71 vaccine has been developed in many countries or regions.~     According to the requirements of drug registration approval, we need to evaluate~     immunogenicity and safety effect on combined immune effect of EV71 inactivated vaccine and~     other vaccines (HepB、MPSV-A、MR、JE-L).~      Method: Four experimental groups (HepB:3+EV71, MPSV-A:1+EV71, MR+EV71, JE-L+EV71) were~     included in this clinical trail. In addition to the meningococcal vaccine research group, the~     other three groups were followed up for the 4 times. The initial blood samples were~     collected, and the first dose vaccine was inoculated at the same time. EV71 second doses of~     vaccine were inoculated at 30 day, the blood was collected after 30 days of immunization with~     second doses. 6 months of safety follow-up was carried out in the whole clinical trial after~     vaccination. The meningococcal vaccine research group increased 1 follow-up after the second~     dose of MPSV-A vaccine. The index of immunogenicity and safety effect in four experimental~     groups need to be evaluated.~   "
3615|NCT03519555|"~     Safety and Performance of the BIOSURE™ REGENESORB Interference Screw in Knee Ligament Repair~     and Reconstruction~   "
3616|NCT03519542|"~     Multicentric and prospective epidemiological study (NON INTERVETIONAL) to identify prognosis~     and predictive biomarkers of response to sunitinib and pazopanib as first line therapy in~     metstatic renal cell carcinoma.~      Molecular determinations will be developed ay CIMA and CNIO.~   "
3617|NCT03519529|"~     Sex hormone-binding globulin(SHBG) is a surrogate marker of insulin resistance. This study~     aims at the characteristic and clinical significance of SHBG and testosterone in patients~     with type 2 diabetes(T2D).~   "
3618|NCT03519516|"~     Phase I clinical trial, to evaluate the safety and tolerability of the ophthalmic solution~     PRO-174 versus Sophixín Ofteno®, elaborated by Laboratorios Sophia, S.A. of C.V. on the~     ocular surface of ophthalmologically and clinically healthy subjects.~      Goals:~      To evaluate the safety and tolerability of the formulation PRO-174 manufactured by~     Laboratorios Sophia, S.A. of C.V. on the ocular surface of clinically healthy subjects.~      Hypothesis:~      The ophthalmic solution PRO-174 presents a safety and tolerability profile similar to the~     comparator in healthy subjects.~   "
3619|NCT03519503|"~     General objective~        -  To assess the long-term safety and efficacy of one-year infant prophylaxis using~          lamivudine (3TC) or lopinavir/ritonavir (LPV/r) to prevent post-natal transmission~          through breastfeeding.~        -  To investigate the biological mechanisms involved in postnatal HIV transmission.~      Specific objectives~        -  To compare the long-term safety of infant prophylaxis using either 3TC versus LPV/r on~          child development (growth, somatic and mental health), mortality, adrenal function,~          liver function, full blood count and mitochondrial toxicity.~        -  To estimate the final efficacy data of 50 weeks of infant prophylaxis using either LPV/r~          or 3TC, since some mothers may have resumed breastfeeding after the trial.~        -  To profile miRNA in breast milk according to maternal HIV status and HIV transmission.~        -  To determine the influence of maternal milk on infant gut inflammation in an in vitro~          3D-intestinal model (CACO-2 cells).~      The study population will comprise all ANRS 12174 PROMISE-PEP trial participants who~     completed the 50 week follow-up and are not HIV infected. An estimate of 881 mother-child~     pairs from the ANRS 12174 PROMISE- PEP will be recruited.~      This study is structured in two parts. The 'clinical & biological safety' component involves~     a cross sectional survey. A clinical and neuropsychological examination of participants will~     be conducted. In addition one venous blood sample will be collected to evaluate children HIV~     status, full blood count, liver & adrenal function and mitochondrial toxicity. Capillary hair~     follicles will be collected from 100 children in Zambia to study their genome integrity.~      The 'mechanisms' component includes biological assays to be conducted on breast milk samples~     previously collected from HIV infected, transmitting or non-infected mothers enrolled at ANRS~     12174 PROMISE-PEP trial.~      Primary endpoint: Long term survival, mortality rate, measurements of infant growth (length~     and weight), somatic and neuropsychological development of the 5 year old children enrolled~     in the ANRS 12174 PROMISE- PEP trial.~      Secondary endpoints: HIV seroconversion since last PROMISE PEP trial visit, full blood count,~     liver function, adrenal function, serum lactate. Number of mitochondrial DNA copies per cell~     & percentage of mitochondrial DNA deletion for mitochondrial toxicity. Number of micronuclei~     & number of Ɣ-tubulin spot per cell to study genomic toxicity.~   "
3652|NCT03519061|"~     This study is intended to assess the impact of a 90 day course of high volume budesonide~     irrigations for patients who have failed other medical therapy and assessing the impact of~     the budesonide irrigations on the need for sinus surgery.~   "
3653|NCT03519048|"~     Phase III randomized trial to compare the efficacy in terms of overall survival of two~     follow-up strategies (conventional versus intensive) among smokers and/or alcohol drinkers~     patients, older than 35 year, in complete remission 2-4 months after treatment of head and~     neck squamous cell carcinoma Patients will be randomized after the post-treatment check-up~     (clinical examination and reference imaging including PET-CT for patients ≥ N2) performed 2~     to 4 months after the end of treatment. The randomization ratio is 1:1.~   "
3654|NCT03519035|"~     Hallucinations in borderline personality disorder are a frequent an serious trouble which~     have an important impact in patients lives. Despite this, they are often ignored by nursing~     staff, and are not an important criteria in DSM 5 and CIM 10 classifications. The main~     objective of our study is to assess the prevalence of this trouble in borderline personality~     disorder (BPD) population, and to characterize the hallucinations in order to compare our~     results with those of international studies.~   "
3620|NCT03519490|"~     Myopia has been increasing in prevalence and severity throughout the world over the last 30~     years. Increasing levels of myopia are associated with increased frequency and severity of~     various ocular pathologies. Slowing myopia progression may help to reduce the future risks of~     these ocular pathologies.~      Conventional spectacles and contact lenses correct myopia by moving the central focus of the~     eye from in front of the retina to on the retina centrally. To varying degrees, these lenses~     allow the light to focus behind the retina, at varying peripheral retinal locations. These~     findings have led to efforts to design spectacle and contact lenses which correct peripheral~     hyperopic defocus, to reduce myopia progression.~      The consensus theory for how both multifocal contact lenses (MFCLs) and orthokeratology can~     control myopia progression is that they reduce, eliminate, or reverse relative peripheral~     hyperopic defocus. Existing published studies on the use of multifocal contact lenses to~     control myopia in humans have utilized lenses with the distance correction in the center with~     peripheral plus power to correct the peripheral blur.~      It is possible that one of the mechanisms responsible for myopia progression control with~     MFCLs is that when the eye is exposed to an image focused on the retina and simultaneously an~     image anterior to the retina, that this will suppress axial elongation and myopia~     progression. This mechanism would not be dependent on whether the anterior image is located~     in the central area of the retina or the peripheral area of the retina. While there are no~     published human studies demonstrating the effectiveness of near center MFCLs, this author has~     presented retrospective data showing no differences in myopia progression between near center~     and distance center MFCLs.~      Synergeyes, Inc.'s Duette contact lenses are hybrids of rigid gas permeable (RGP) with a~     silicon hydrogel peripheral portion or skirt. They now make their MFCLs in both distance~     center (DC) and near center (NC) designs.~      This study will analyze the myopia progression of children after being randomly assigned to~     wear Duette MFCLs or Duette standard single vision contact lenses over a span of two years.~     Subjects assigned to the MFCL group will wear a DC lens on one eye and a NC lens on the other~     and will reverse this lens assignment every six months. Refractive changes will be measured~     by cycloplegic autorefraction and axial lengths will be measured with a laser interference~     biometer (Zeiss IOLMaster) at six-month intervals.~   "
3621|NCT03519477|"~     The purpose of this study is to evaluate the clinical utility of comprehensive medication~     monitoring using the Patient Medication Profile to improve heart failure patient medication~     therapy and associated outcomes relative to usual care in a hospital setting.~   "
3622|NCT03519464|"~     Background:~      Diseases related to human papillomavirus (HPV) include warts, lesions, and cancers. ICL is~     idiopathic CD4 T cell lymphocytopenia. People with this rare disease get more HPV-related~     diseases than other people do. The diseases are more severe and harder to treat in people~     with ICL. Researchers want to see if the vaccine GARDASIL 9 can help people with ICL.~      Objective:~      To study the effects of the vaccine GARDASIL 9 in people with ICL.~      Eligibility:~      Adults ages 18-60 with ICL~      Healthy volunteers the same age~      Design:~      Participants will be screened with a physical exam, medical history, and blood and pregnancy~     tests.~      Participants will have a baseline visit with:~        -  Physical exam~        -  Medical history~        -  Oral rinse collection. Participants will gargle a small amount of a saline solution,~          then spit it into a cup.~        -  Apheresis. Blood will be removed through a needle in an arm. A machine will separate the~          blood and keep some parts for research. The rest will be returned to the participant~          through a needle in the other arm.~        -  Examination for HPV-related disease. Female participants will have a Pap test.~      Researchers will collect swabs from some participants skin or genital lesions.~      Participants will get 3 doses of the study vaccine over 6 months as a shot in the upper arm~     or thigh muscle. They will repeat the screening tests each vaccine visit.~      Participants will record their temperature and side effects for several days after~     vaccinations.~      Participants may have visits after vaccinations.~      Participants will have 2 follow-up visits in the 18 months after the last vaccine. They will~     repeat most of the baseline tests.~   "
3623|NCT03519451|"~     The goal of this research study is to compare the effectiveness of 2 different smartphone~     applications (apps). The apps are designed to help you quit smoking in combination with~     tobacco cessation (quitting) counseling.~      This is an investigational study.~      Up to 24 participants will be enrolled in this study. All will take part at MD Anderson.~   "
3624|NCT03519438|"~     The aim of this study is to examine alterations in the skin microbiome that occur during~     radiation therapy. The study design will examine changes secondary to ionizing radiation, and~     correlate these changes with the development and severity of radiation dermatitis. The goal~     is to improve understanding of the mechanism of radiation dermatitis.~   "
3625|NCT03519425|"~     A pragmatic open, three-arm individually-randomised controlled trial and economic evaluation~     will be conducted in one primary health care centre in Blantyre, Malawi, where HIV and TB are~     major contributors to early mortality.~      Participants will be adults with symptoms of tuberculosis (cough of any duration) attending~     the primary clinic with an acute care episode. We will exclude adults who have taken~     treatment for TB within the previous 6-months, who are taking isoniazid preventive therapy,~     who are not resident of Blantyre, or who plan to move out of Blantyre in the following~     6-months.~      Participants will be randomly allocated into one of three groups:~      Group 1: Standard of care: Participants will be seen by facility health workers and receive~     clinician-directed screening for HIV and TB according to Malawi national guidelines.~      Group 2: Optimised HIV testing and treatment linkage: Participants will be offered testing~     for HIV using rapid oral fluid kits by research assistants. Those with confirmed HIV~     infection will be linked to the HIV care clinic where facility healthworkers will screen for~     TB using standard sputum-based diagnostics.~      Group 3: Optimised TB diagnosis, HIV screening and treatment linkage: Participants will~     receive a high-throughput and high-sensitivity TB screening intervention, in addition to the~     HIV testing intervention. This will comprise of an initial digital chest x-ray classified by~     the CAD4TB image-recognition software as either high probability of TB, or low probability~     of TB. Participants whose x-rays are suggestive of TB will receive confirmatory sputum~     testing with Xpert MTB/Rif Ultra cartridges, whilst participants whose x-rays have a low~     probability of TB will be referred to facility healthworkers for routine care.~      All participants will be seen at the health facility at day 56, where they will be tested for~     HIV (if not on ART) and screened for TB.~      The Primary Trial Outcome will compare between groups the time to tuberculosis treatment~     initiation by day 56. The trial is sufficiently powered to permit 3 pairwise comparisons~     between groups (i.e. Group 1 vs. 2; Group 2 vs. 3; and Group 1 vs. 3).~      This three-arm pragmatic trial design allows us to efficiently answer two separate, important~     public health questions: firstly, by comparing Group 2 to Group 1, we should be able to~     determine whether HIV care should be prioritised for adults with TB symptoms. Additionally,~     by comparing Group 3 to Group 2, we will provide strong evidence for the effectiveness of an~     optimised and integrated HIV and TB diagnostic and treatment linkage approach.~   "
3626|NCT03519412|"~     In this study, metastatic colorectal cancer (CRC) patients with RAS-extended mutations who~     failed standard therapies will be tested for MMR-deficiency. MMRd patients will undergo~     treatment with pembrolizumab while MMR-proficient patients will be tested for~     o6-methylguanine-DNA-methyltransferase (MGMT) expression (IHC) and then for MGMT promoter~     methylation. MGMT IHC-negative, promoter methylation positive patients will be treated with~     temozolomide (TMZ). Patients progressing under temozolomide will be tested for tumor~     mutational burden (TMB) and proceed to pembrolizumab if TMB is > 20 mutations/Mb. The primary~     study hypothesis is that tumors with acquired resistance to temozolomide become hypermutated~     and are sensitive to pembrolizumab.~   "
3655|NCT03519022|"~     This study will determine the influence of methylphenidate (Metadate®) and duloxetine~     (Cymbalta®), alone and in combination, on the reinforcing, subjective and physiological~     effects of cocaine.~   "
3702|NCT03518411|"~     1. Recruitment of medicine students of federal university.~        2. Psychiatric interview (MINI) and sclaes application.~        3. Protocol of CBT~        4. Scales and MINI will be applied at the times of 7, 30 and 90 days after the end of the~          therapy.~        5. Statistical analysis~   "
3627|NCT03519399|"~     Intrahepatic cholestasis of pregnancy (ICP) is a liver disorder of pregnancy that typically~     presents in late pregnancy with generalised itching. ICP is associated with an increased risk~     of pregnancy complications, including premature labour, fetal distress, and stillbirth.~     Models of the fetal heart (using cells from rodents) have shown that high bile acids levels~     cause an abnormal heart rhythm (arrhythmia), which may be the cause of stillbirth. High~     levels of bile acids also cause preterm labour in animal models.~      This pilot study aims to assess whether severe ICP, defined as maternal serum bile acid~     levels ≥40μmol/L, is associated with abnormal fetal heart rhythms and abnormal myometrial~     contractility, which may lead to preterm birth.~      Fetal heart rhythms and myometrial contractility will be recorded using a portable~     electrocardiogram (ECG) device, the Monica AN24. This monitors the fetal heart and myometrial~     activity via stickers applied to the mother's abdomen. It also records the maternal ECG. We~     will also study women with uncomplicated pregnancy, in order to make comparisons.~      The importance of maternal position during sleep has also more recently been established,~     with some studies demonstrating an association between the risk of stillbirth and the~     position the mother was sleeping in (Stacey et al,2011). Work by Stone et al published this~     year has shown that the maternal sleep position has a significant impact on the fetal sleep~     state and fetal heart rate, (in particular something called the fetal RMSSD value), (Stone et~     al,2017). We therefore wish to identify any potential correlation between fetal heart~     arrhythmia and maternal sleep position. To do this we will use a Zephyr BioPatchTM which~     provides a clear indication of whether the patient was in left lateral, right lateral or~     supine position.~   "
3628|NCT03519386|"~     Phase III study to compare the safety and efficacy of intraocular implants containing~     travoprost at two different elution rates versus Timolol Maleate Ophthalmic Solution, 0.5%~     (timolol) in reducing elevated intraocular pressure in subjects with open-angle glaucoma~     (OAG) or ocular hypertension (OHT).~   "
3629|NCT03519373|"~     The impact of chronic HIV infection and pregnancy on different aspects of the humoral~     response to pertussis immunization with the TDaP vaccine will be studied. The parameters will~     be measured in 3 groups (HIV-infected pregnant, HIV-uninfected pregnant and HIV-uninfected~     non pregnant) at different time points before and after immunization (7-10 days, 30 days and~     at delivery). The transfer ratio and the quality of maternal antibodies will be studied in~     cord blood.~   "
3630|NCT03519360|"~     The purpose of this study is to test the feasibility of trials that change the dialysis~     ultrafiltration rate (UFR) by limiting the maximum rate and to estimate the extent to which~     limiting the ultrafiltration rate reduces the risk of abnormal heart rhythms in people with~     kidney failure who are being treated with chronic hemodialysis.~   "
3631|NCT03519347|"~     The primary purpose of this study is to test the feasibility of trials which change the~     dialysate (dialysis bath prescription) of potassium and bicarbonate according to a~     standardized algorithm and according to the results of blood testing performed prior to each~     dialysis. In addition, the trial will provide estimates of the extent to which performing~     dialysis in this way lowers the risk of abnormal heart rhythms in people with kidney failure~     who are being treated with chronic hemodialysis.~   "
3632|NCT03519334|"~     PATHWAYS is a 3-year project that directly contributes to the 2014 Work Programme by focusing~     on action 2.1.1.3 regarding the development of innovative approaches to promote the~     professional integration and reintegration of people with chronic diseases and improve their~     employability. The main aim of PATHWAYS is to provide evidence-based recommendations for the~     effective professional integration of people with chronic health conditions in Europe~   "
3633|NCT03519321|"~     Early Onset Scoliosis (EOS) is defined as scoliosis with onset under the age of ten years,~     regardless of etiology. It is a complex three-dimensional deformity of the spine which can~     cause significant physical and psychological problems. Currently there are two basic~     treatment options available for EOS: non-surgical and surgical. ApiFix Ltd. has developed a~     novel growing rod system for surgical treatment of EOS, the MID-C system. It is indicated for~     patients with a scoliosis of 35 to 75 degrees Cobb angle~   "
3634|NCT03519308|"~     The main purpose of this study is to look at the potential effects of paricalcitol (a drug~     similar to vitamin D) and nivolumab on pancreatic tumors in patients who are treated with~     gemcitabine and abraxane. The study will also look at the safety of including paricalcitol~     and nivolumab as part of the gemcitabine and abraxane chemotherapeutic regimen.~   "
3635|NCT03519295|"~     SCARCE is a non-comparative randomized, 2:1 phase II study. The purpose of this study is to~     assess the progression-free survival rate at 12 months. (evaluation according with RECISTv1.1~     criteria).~      For all patients, CT scan will be planned at baseline, and every 8 weeks until 12 months from~     randomization (or disease progression), and every 12 weeks thereafter.~      PET scan will be performed at baseline, at the end of mDCF treatment, and at 12 months after~     randomization (in absence of disease progression).~      CT scan and PET scan will be collected for a centralized review.~   "
3636|NCT03519269|"~     Total knee replacement surgery is a conventional approach to alleviating the pain and lack of~     function resulting from arthritis of the knee. While conventional knee replacement surgery is~     highly successful, incidences of improperly installed replacement parts are not uncommon. To~     improve outcomes, robotic-assisted total knee replacement surgery has recently become~     available, and has been shown to be extremely effective for partial knee replacement surgery.~     However, further research is needed to determine if this same technology can be equally~     effective for total knee replacement surgery. The present study will evaluate outcomes of~     robotic-assisted versus conventional total knee replacement surgery in patients between 40~     and 85 years old with end stage arthritis of the knee. Other than surgical technique,~     patients will receive the same operative care and knee replacement implants. In addition to~     standard x-rays, subjects will be asked to complete several short-term clinical and~     functional tests and questionnaires to determine outcomes of their surgery.~   "
3637|NCT03519256|"~     A study to evaluate Nivolumab or Nivolumab Plus Experimental Medication BMS-986205 with or~     without BCG in BCG-Unresponsive non-muscle invasive Bladder Cancer~   "
3638|NCT03519243|"~     BCD-131 is pegylated darbepoetin beta. BCD-131-2 is International Multicenter Randomized~     Open-Label Comparative Study (Phase II) of the Efficacy and Safety of BCD-131 (JSC BIOCAD,~     Russia) and Mircera (F. Hoffmann-La Roche Ltd, Switzerland) in Treatment of Anemia in Chronic~     Kidney Disease Patients on Dialysis~   "
3644|NCT03519165|"~     This is a single center prospective randomized controlled study comparing the postoperative~     outcome after cytoreductive surgery in ovarian cancer patient after using restrictive or~     individualized goal-directed fluid replacement strategy (GDT). Aim of this study will be to~     test the hypothesis that intra-operative SVV-guided fluid optimization during ovarian cancer~     cytoreductive surgery:~        1. reduces the postoperative length of hospital stay,~        2. cost-effective,~        3. GDT will be more beneficial in cases of PDS compared to IDS or cytoreductive procedures~          of shorter duration.~        4. GDT improves intraoperative tissue perfusion/ oxygenation and improves immediate~          postoperative morbidity.~      Intra-operatively fluid of choice in both groups will be lactate-free crystalloid at 1.0~     ml/kg/h for maintenance and gelofusine for fluid bolus of 3ml/kg over 5 minutes. In group C~     intraoperative fluid therapy will include maintenance fluid and replacement of the surgical~     loss. Aim will be to maintain MAP > 65 mmHg, CVP 8-12 cm H2O and urine output > 0.5 ml/kg/h.~     In group G intraoperative fluid therapy will be targeted to SVV <13%, SVI > 35ml/m2/ beat,~     SVRI more than equal to 1900 dynes-sec/cm-5/m2 in addition to clinical parameters like MAP,~     CVP and urine output.~      Primary outcome will be length of hospital stay (LOS). Secondary outcomes will be cost of~     surgical treatment episode (admission till fit to discharge), postoperative morbidity survey~     (POMS) and 30 day morbidity and mortality.~   "
3645|NCT03519152|"~     Pain after periodontal surgical procedures is a common manifestation. The perception of pain~     is highly subjective and varies substantially among individuals. Many factors affect pain~     perception, such as the nature, duration, and extent of the surgery and psychological aspects~     (e.g., stress and anxiety). Pain after periodontal surgery is an example of acute dental pain~     of mild to moderate severity. Non-steroidal anti-inflammatory drugs (NSAIDs) have a~     significant advantage in the control of pain after periodontal or oral surgical procedures.~      Diclofenac is a powerful anti-inflammatory and analgesic drug that is well suited for local~     use in the oral cavity. Diclofenac competes with arachidonic acid in a dose dependent manner~     for binding with platelet COX. This results in decreased production of PG and thus reduces~     inflammation, swelling and pain.~      As Diclofenac associated with many adverse effects, like gastric irritability, nausea,~     headache, dizziness. Undesirable effects may be minimized by using the lowest effective dose~     for the shortest duration necessary to control symptoms. As many of clinical trials have~     suggested Diclofeanc 50 mg alleviates the postoperative pain. So main aim of the study was to~     evaluate the effectiveness of low dose Diclofenac(25mg) in reducing the post operative pain~     after periodontal flap surgeries. Thus comparing the effects of low dose Diclofenac and~     Diclofenac 50mg for reducing post-operative pain.~   "
3646|NCT03519139|"~     The purpose of this study is to investigate whether a four-week individual nutritional~     intervention can reduce the readmission/hospitalization rate among geriatric patients who are~     discharged to their private home or respite care. Secondarily, whether an individual~     nutritional intervention can improve nutritional status, functional status, quality of life,~     muscle strength and reduce mortality in geriatric patients after discharge Two sub-points are~     investigated using feasibility studies - if photography documentation of meals can be used in~     practice to assess the energy and protein intake of geriatric patients and whether~     photography documentation of the refrigerator content at first home visits in the~     intervention group can predict whether there is an increased risk of readmission.~   "
3647|NCT03519126|"~     This is a clinical trial whose objective is to compare the efficacy of transcutaneous~     electrostimulation of the posterior tibial nerve with intravaginal electrostimulation in the~     treatment of women with symptoms of idiopathic overactive bladder. The volunteers will be~     randomly randomized into three study groups: posterior tibial group, vaginal group and~     control group. They are evaluated at three times: before the start of treatment, at the end~     of 6 weeks of treatment and after 1 month (follow up). The evaluation will occur through a~     voiding diary and a quality of life questionnaire. For the treatment groups will be used~     depolarized biphasic current with frequency of 10 Hz and pulse width of 200 μs, and intensity~     according to the tolerance of the patient. The hypothesis of the study is that the two forms~     of electrostimulation for treatment of idiopathic overactive bladder will be effective, but~     transcutaneous electrostimulation of the posterior tibial nerve will be more effective than~     intravaginal.~   "
3648|NCT03519113|"~     This is a clinical study for GC1102 to demonstrate preventing the recurrence of hepatitis B~     virus (HBV) infection following liver transplantation and a dose-finding study to determine~     its optional dose.~   "
3649|NCT03519100|"~     Quality of life and satisfaction in aesthetic surgery is still under-evaluated. It is a~     prospective and multicenter study with a 4 months follow-up of patients under rhinoplasty or~     rhinoseptoplasty procedure. They will answer to the FACE-Q and NOSE questionnaires before~     surgery, one week later and 4 months after the procedure. The aim of the study is to show a~     significant augmentation of the quality of life scores. At this occasion, the FACE-Q~     questionnaire has been translated and validated in French~   "
3650|NCT03519087|"~     The investigators aim to understand how interdisciplinary care influences decisions,~     expectations, and outcomes for patients with non-arthritic hip disease (NAHD). Patients~     presenting to the Ohio State University Wexner Medical Center (OSUWMC) Hip Preservation~     Clinic will be approached for participation. All participants will proceed with their~     scheduled, standard-care physician evaluation. Participants without NAHD will be excluded.~     Participants will then be randomized to receive a same-day physical therapist (PT)~     evaluation. This PT evaluation is not a standard-care practice in the clinic, this was added~     for research. All participants will complete expectation surveys before and after their~     evaluation(s). The clinicians will discuss their recommended plan with the patient and the~     patient will record a final treatment decision and outcome expectations. Participants will~     then be randomized to either receive posture and movement training (PMT) for 3 weeks or~     undergo a 3-week wait period. All participants will be required to withhold any treatment~     during this 3-week period (except PMT in the PMT group). The 3-week wait period for the~     no-PMT group is aligned with current clinical processes for time from physician evaluation to~     start of treatment. All participants may proceed with any further interventions (including~     PMT) after the 3-week period, but none will be provided/required as part of research.~     Patient-reported outcomes and clinical tests will be recorded before and after the 3-week~     period, and 3 and 6 months later. Adding a PT evaluation to the physician visit provides no~     additional risk because the PT evaluation includes similar clinical tests to the physician~     and movement analysis during tasks participants complete during daily life. Clinical tests~     before/after the 3-week intervention period may produce muscle soreness that should resolve~     within 2 days. Understanding how interdisciplinary care influences expectations and outcomes~     can inform clinicians regarding the effectiveness of interdisciplinary collaboration.~   "
3651|NCT03519074|"~     The purpose of this study is to formally characterize the pharmacokinetics (PK), safety, and~     tolerability of TS-1 in combination with cisplatin in adult patients with advanced solid~     tumors who have mild, moderate or severe hepatic impairment relative to patients with normal~     hepatic function, as categorized by the United States National Cancer Institute organ~     dysfunction working group [NCI-ODWG] criteria for hepatic dysfunction.~   "
3656|NCT03519009|"~     Addiction is a chronic relapsing disorder. High magnitude and long-duration voucher-based~     abstinence reinforcement is one of the most effective treatments for alcohol and drug~     addiction and can maintain abstinence over extended periods of time, but practical methods of~     implementing these interventions are needed. Workplaces could be ideal and practical vehicles~     for arranging and maintaining abstinence reinforcement over long time periods. Investigators'~     research on a model Therapeutic Workplace has shown that employment-based abstinence~     reinforcement, in which participants must provide alcohol- or drug-free urine samples to~     maintain maximum pay, can maintain alcohol and drug abstinence. Now investigators need to~     develop effective and economically sound methods to arrange long-term exposure to~     employment-based abstinence reinforcement. Investigators are proposing to evaluate the~     effectiveness and economic benefits of a Wage Supplement Model of arranging long-term~     exposure to employment-based abstinence reinforcement. Under this model, successful~     Therapeutic Workplace participants are offered abstinence-contingent wage supplements if they~     obtain and maintain competitive employment. Governments have used wage supplements~     effectively to increase employment in welfare recipients. The Wage Supplement Model harnesses~     the power of wage supplements to promote employment, while simultaneously using the wage~     supplements to reinforce drug and alcohol abstinence. The intervention will combine 3~     elements -- the Therapeutic Workplace, Individual Placement and Support (IPS) supported~     employment, and abstinence-contingent wage supplements. IPS is a supported employment~     intervention that has been proven effective in promoting employment in adults with severe~     mental illness. Under this model, participants will be exposed to the Therapeutic Workplace~     to initiate abstinence and establish job skills. To promote employment and prevent relapse to~     drug use, participants will receive IPS Plus Abstinence-Contingent Wage Supplements. A~     randomized trial will evaluate the effectiveness and economic benefits of the~     Abstinence-Contingent Wage Supplement Model in promoting employment and sustaining drug~     abstinence. Participants will be enrolled in the Therapeutic Workplace for 3 months and then~     randomly assigned to a Usual Care Control group or an IPS Plus Abstinence-Contingent Wage~     Supplement group for one year. Usual Care Control participants will be offered counseling and~     referrals to employment and treatment programs. IPS Plus Abstinence-Contingent Wage~     Supplement participants will receive the IPS intervention and abstinence-contingent wage~     supplements. This novel intervention could be an effective and economically sound way to~     promote long-term employment and drug abstinence.~   "
3657|NCT03518996|"~     The purpose of this study is to examine whether non-invasive brain stimulation can be used to~     improve cognitive deficits in patients with delirium.~   "
3658|NCT03518983|"~     This is a double-blind, sham-controlled randomized, 2 parallel arms, clinical trial with a~     12-month recruitment period. All patients will be PDE5I users/responders. After 1 month~     wash-out period, ED patients will be screened, in order to randomize 70 men with vasculogenic~     ED.Patients will be randomized in 2 groups (35 subjects in each group) to receive shockwave~     treatments (12 sessions for all subjects, 5000 shockwaves at each session), twice a week~     (total of 6 weeks) either at energy level 7 or at sham-control , without treatment interval.~     The IIEF-ED domain will be evaluated at Visit 1 and, consequently, at baseline and all follow~     up visits together with the SEP diaries.~   "
3659|NCT03518970|"~     Background: The increase of chronic diseases has reached an increase in the suffering of~     advanced diseases and an inability of health care systems to give access to the population~     that suffers them. In this context are people with advanced cancer who are in palliative care~     and the family caregivers. Uncertainty in illness in palliative care and quality of life are~     two concepts that are altered in the patient's family caregiver in palliative care.~     Objective: to examine the feasibility and acceptability of a nursing intervention to reduce~     the uncertainty in illness and improve the quality of life of family caregivers of patients~     with cancer in palliative care. Methodology: Phase II clinical trial, the ratio of~     recruitment, follow-up of participants as well as satisfaction with the intervention will be~     evaluated as primary outcomes. As secondary outcomes, the possible effect of the intervention~     on the uncertainty in illness and the quality of life of the family caregiver will be~     evaluated. This study will be carry out in a health care institution in Medellin-Colombia.~   "
3660|NCT03518957|"~     Exercise in early breast cancer patients has the potential to improve depression, anxiety,~     fatigue, quality of life and even survival. The effects of exercise may come about by way of~     changes in weight, immune markers and telomere length, but data on this so far has not been~     conclusive. To better understand the physical, psychological, and biological effects of~     exercise on breast cancer survivorship, the investigators propose to perform a phase III~     randomized controlled trial of a 12-week exercise intervention program versus usual care in~     early stage breast cancer patients, and will follow up the patients prospectively for 5~     years, with serial assessment of physical and functional activity, QoL, depression and~     anxiety scores, telomere length and plasma immune markers.~   "
3661|NCT03518944|"~     Premature ovarian insufficiency (POI) is a clinical syndrome defined by loss of ovarian~     activity before the age of 40 years. The POI guideline development group of ESHRE recommends~     the following diagnostic criteria: oligo/ amenorrhea for at least 4 months and an elevated~     follicle stimulating hormone (FSH) level ＞25 mIU/mL on two occasion ＞4 weeks apart. Some~     clinicians and researchers proposed that POI was a progressive disease and there were three~     stages of POI: occult POI, biochemical POI, overt POI. However, there is lack of reliable~     indicators to assess the different stages of POI. The present study is to explore the change~     of menstruation condition, basal follicle-stimulating hormone, anti-müllerian hormone and~     antral follicle count during the development of POI, and whether those marks can assess the~     different stages of POI.~   "
3662|NCT03518931|"~     The purpose of the study is to determine how measuring strength (by squeezing a tool called a~     hand grip dynamometer) and cardiorespiratory fitness (by climbing stairs) and sharing the~     results with subjects impacts exercise.~   "
3663|NCT03518918|"~     The study aims to establishing the diagnosis standard of POI and analyzing the risk factors~     in Chinese women.~   "
3664|NCT03518905|"~     The heterotopic gastric mucosa found in the cervical esophagus was first described in 1805~     and affects 10-15% of individuals undergoing esophagogastroduodenoscopy. It leads to~     laryngopharyngeal reflux (LPR), which causes symptoms like globus sensation, hoarseness and~     chronic cough. The Reflux Symptom Index (RSI) that ranges from 0-45 measures LPR. Scores~     greater than 13 are considered to be pathologic. Currently, patients that suffer from~     symptoms of LPR and present with a heterotopic gastric mucosa are routinely offered~     radiofrequency ablation (RFA) as curative treatment. Up to now, around 40 patients were~     already treated at the department of Surgery with 90% histologic eradication rates after 2~     treatment sessions and no reported serious adverse event. Nevertheless, the placebo effect~     could also be responsible for perception of improving symptoms. Therefore, this prospective~     sham-controlled trial was designed to exclude the placebo effect. As the device is already~     approved and routinely used for focal ablation safety data are already available. Up to now,~     there were no major adverse events, whereas only 10% of patients describe a sensation of~     irritated throat that dissolves within the first three days after treatment.~   "
3665|NCT03518892|"~     Assess the relationship between body composition, metabolism, and dietary needs in people~     with spinal cord injury compared to their healthy controls that are age and sex matched.~   "
3666|NCT03518879|"~     Through this study, the investigators developed the ASTHMA-Educator mobile application, and~     evaluated its use among adult asthma patients at Montefiore.~   "
3667|NCT03518866|"~     This main objective of this feasibility study is to begin to quantify the relationship~     between patient activity levels following knee replacement surgery and outcomes.~   "
3668|NCT03518853|"~     Hypofractionated external beam radiotherapy has been clinically used for localized prostate~     cancer in view of the low estimated alpha/beta ratio of prostate cancer cells. Moderate~     fraction sizes of <4Gy per fraction has been investigated in several phase II/III studies and~     has been found to be well tolerated with comparable biochemical control in comparison with~     standard fractionated dose-escalated regimens. Fraction sizes of > 4 Gy has also been~     investigated in single center studies. However, its toxicity and disease control outcomes is~     less well known. In this Phase I/II single arm study the investigators aim to treat~     non-metastatic prostate cancer with stageT1-T4N0M0 and Prostate Specific Antigen (PSA) <60~     ng/ml to a regimen of 35Gy in 5 fractions delivered once a week with a view to determine~     acute toxicity, biochemical control with PSA and late toxicity.~   "
3669|NCT03518840|"~     During pregnancy, women often experience musculoskeletal pain, specifically in their low back~     and/or pelvic girdle. Pelvic girdle pain (PGP) is defined as pain between the posterior iliac~     crest and gluteal fold, particularly in the region of the sacroiliac joint (SIJ)1. Although~     it is often referred to as sciatica. PGP in pregnancy is common with prevalence estimates~     of 45%2. Previous studies have found that one third of patients will rate their PGP intensity~     as severe, leading to functional impairments. Functional disabilities include sitting,~     walking, and standing; thus, significantly impacting the ability of patients to perform~     routine daily activities. This pain has been reported to develop as early as 17-19 weeks'~     gestation, lasting up to 3 months postpartum; with a peak incidence of 24-36 weeks.~      The etiology of PGP in pregnant women is still not fully understood, largely due to the~     complex interactions between bone, ligaments, fascia, and muscles in the pelvic joints3. Some~     studies suggest the increased mobility of the joints in the pelvic girdle during pregnancy~     due to relaxing cause a lack of stabilization in the sacroiliac region, which results in~     pain4. Thus, it is hypothesized that providing stabilization of the joints with an external~     force, such as a maternity or SIJ belt, will improve pain.~   "
3670|NCT03518827|"~     The study will assess the associations between various asymmetries (strength, flexibility,~     balance, etc.) in different athletes. After the measurements, injury occurrence will be~     tracked prospectively for 1 year, and retrospective analysis will be performed as well. The~     main aim of the study is to determine the asymmetries that impose the biggest injury risk for~     athletes.~   "
3671|NCT03518814|"~     Few studies have been conducted on the quality of life of patients with stage IV melanoma.~     Particularly, there is no data regarding the quality of life of patients with a~     multimetastatic melanoma currently in remission.~      Then, the main objective of this study is to evaluate the quality of life from a point of~     view medico-psycho-social in patients with multimetastatic melanoma in remission for more~     than 6 months.~   "
3672|NCT03518801|"~     The trial will include a randomized control trial to evaluate the efficacy of using~     Cannabidiol (CBD), a non-intoxicating cannabinoid, as an adjunctive to Prolonged Exposure~     therapy (PE). The trial will compare PE + CBD to PE + placebo in a sample of 136 military~     Veterans with PTSD at the VA San Diego Medical Center. The study represents the logical and~     innovative next step for augmenting existing treatments and developing novel pharmacotherapy~     for PTSD. Findings from the proposed RCT will inform clinical practice and policy by~     investigating whether administration of CBD in the context of PE therapy will improve~     treatment outcomes for military Veterans with PTSD.~   "
3673|NCT03518788|"~     This is a prospective randomized study whose aim is to compare the efficacy of the permanent~     thoracic catheter (Pleur-X) versus chemical pleurodesis in videothoracoscopy (VATS) in the~     treatment of malignant pleural effusion at the first diagnosis.Patients with malignant~     pleural effusion for whom there is indication of surgery and who agree to participate in the~     study will be randomized 1: 1 in the Pleur-X arm (arm 1) or in the chemical pleurodesis arm~     (arm 2).~      The arm 1 provides for the installation of a permanent drainage under local anesthesia while~     the arm 2 provides a pleurodesis with talc in VATS under general anesthesia.~      Both procedures are standard of care.~   "
3674|NCT03518775|"~     The objectives of this study are to determine the agreement of measurements between the~     IOLMaster 700 SW Vers. 1.70 and IOLMaster 700 SW Vers. 1.50 and Pentacam, as well as to~     evaluate the repeatability and reproducibility of the IOLMaster 700 SW Vers 1.70.~      The following parameters will be evaluated for Total Keratometry, (TK) and Posterior Corneal~     Surface (PCS):~        -  cylinder (CYL), Axis (A)~        -  spherical equivalent (SE)~      Specific Objectives:~        1. To compare the agreement of SE between IOLMaster 700 SW Vers. 1.70 and IOLMaster 700 SW~          Vers. 1.50 (Carl Zeiss Meditec AG, Jena, Germany)~        2. To compare the agreement of Cylinder magnitude and axis between IOLMaster 700 SW Version~          1.70 and Pentacam~        3. To evaluate the repeatability and reproducibility of the IOLMaster 700 SW Vers. 1.70 for~          all measurement parameters listed above~   "
3675|NCT03518762|"~     This is a randomized controlled study to investigate the effect of application of sustained~     lung inflation (SLI) at birth on the respiratory outcome of preterm infants with respiratory~     distress syndrome.~   "
3676|NCT03518749|"~     Deficient cognitive control (CC) is one of the central characteristics of major depression~     (MD). Hypoactivation of the dorsolateral prefrontal cortex (dlPFC) has been linked with this~     deficit. Antidepressants and cognitive-behavioral therapies modify CC most-likely as a common~     mechanism of treatment. Transcranial direct current stimulation (tDCS) is a safe, simple and~     effective non-invasive method to modulate the cortical excitability. It has been shown, that~     the activity of the dlPFC can be modulated by transcranial direct current stimulation (tDCS)~     with polarity-dependent learning-phase specific effects on performance that, when combined~     with training, can outlast the stimulation.~      The goal of this randomized, sham-controlled, rater blind clinical trial is to investigate~     the effect of a tDCS-enhanced CC Training (CCT) on depressive symptom severity and compare~     the stimulation intensities 1mA, 2mA and sham tDCS. Overall, the study will include 57~     participants (n = 19 per group). Each participant will complete 12 training sessions with~     online sham/ anodal tDCS.~      As a training task we will use an adaptive version of the paced auditory serial addition task~     (PASAT). In the PASAT, digits are presented auditive and participants have to add the current~     digit to the digit they heard before. In the adaptive version the interstimulus-intervals~     decrease (increase) when four consecutive trials are correct (incorrect). The PASAT is known~     to elicit frustration. Participants have to exert cognitive control over these emotions to~     complete the task successfully.~      Before, during and after the training symptom severity will be assessed. Baseline and~     post-training performance in the PASAT and in a transfer task (delayed working memory task,~     DWM) will be measured.~      To further explore variables that influence the effect of tDCS on depressive symptom severity~     we will measure brain activity (EEG, NIRS), heart rate, global functioning (GAF), emotion~     regulation strategies, self-esteem, mood ratings and subjective performance ratings before~     and after the training and collect genetic factors.~      Sustainability of the training effects will be measured at a follow-up visit (3 months~     later).~   "
7075|NCT03474237|"~     The purpose of this study is to investigate the pathologic features, complications, and~     prognostic factors of functioning adrenal adenoma and suggest follow-up algorithms for~     adrenal incidentaloma.~   "
3677|NCT03518736|"~     Infants born very preterm (≤28 weeks of gestation) are at high risk of having developmental~     disabilities including cerebral palsy, coordination impairments, attention deficit and~     learning disabilities. Impairment including reduced postural control, movement variability,~     visual motor skills, and motor learning are common during the first months of life and are~     associated with later developmental disabilities. However, infant born very preterm rarely~     receive evidence based therapeutic intervention in the first months of life when basic~     science and animal intervention studies suggest the greatest efficacy. Barriers to enrollment~     in services delay the onset of services and delivery models rarely support targeted~     preventative intervention or enhanced parent engagement during in the transition from the~     neonatal intensive care unit (NICU) to home.~      Targeted intervention supporting postural control and motor learning in the NICU have~     resulted in short term motor gains. Interventions that enhance parent's ability to read their~     infant's cues and provide engagement opportunities improve maternal mental health and infant~     social and cognitive outcomes in the short-term. The purpose of this randomized clinical~     trial is to evaluate the efficacy of an intervention that combines evidence based motor~     intervention and parent engagement to enhance the parent's ability to provide daily motor and~     cognitive opportunities resulting in improved motor and cognitive outcomes.~      Supporting Play Exploration and Development Intervention (SPEEDI) uses guided participation~     to empower parents in reading infant's behavioral cues, identifying ideal times for~     interaction, and enriching the environment and learning opportunities. Parents participate in~     5 session in 3 weeks while learning principles of engagement, readiness for interaction, and~     to provide early motor and cognitive learning opportunities. Parents provide 20 minutes of~     motor and cognitive play based enrichment daily for 12 weeks with bi-weekly physical~     therapist support. The parent is empowered to determine the infant's current abilities and~     advance the activities to the Just Right Challenge throughout the 12 weeks, likely~     continuing after the intervention.~      The efficacy of SPEEDI will be assessed during delivery at 2 time point; the transition from~     the NICU to home (around the infant's due date) and at 3-4 months of adjusted age (after the~     infants due date). Ninety infants will be randomly assigned to a Usual Care group,~     SPEEDI_Early, or SPEEDI_Later group. Group differences will be assessed in developmental~     outcomes on the motor and cognitive scales of the Bayley Scales for Infant and Toddler~     Development as well as the Early Problem Solving Indicator and Gross Motor Function Measure~     at the end of each intervention period, 12 and 24 months of age.~   "
3678|NCT03518723|"~     This study aims at improving the knowledge about resistance training for people with COPD.~     Resistance training is an important part of pulmonary rehabilitation when the goal is to~     improve muscular endurance and strength. The study will evaluate the effects and the~     feasibility of two resistance training programs for people with COPD using a parallel group~     design. One program will include a larger day-to-day variation (i.e. non-linear~     periodization) and the progression will be guided by ratings of dyspnea, muscle fatigue, and~     exertion. The other program will follow the established guidelines for resistance training~     for people with COPD. The programs will be evaluated for effects regarding muscular~     endurance, strength, intramuscular adaptions, functional preformance, dyspnea, and health~     related quality of life. The programs will also be evaluated for feasibility regarding the~     duration of training sessions, attendance rates, adverse events, and participant~     satisfaction. The hypothesis is that the non-linear periodization group will have superior~     effects and that feasibility aspects will be similar between groups.~   "
3679|NCT03518710|"~     The present project will therefore focus upon those processes related to visual attention and~     perceptual abilities and on their potential to explain reading behavior and reading problems~     in NF1. The main objective of this study is to clarify the specificity and heterogeneity of~     reading profiles and the causes of its disturbance in NF1. In particular, this project allow~     the investigators to study more precisely the relations between perceptual, oculomotor and~     visuo-attentional skills in NF1 children and reading abilities. In addition, a new~     oculomotor/perceptual reading aid for NF1 children will be evaluated. The investigators~     believe that the early intervention for perceptual, visuo-attentional or oculomotor problems~     may promote academic skill development.~   "
3680|NCT03518697|"~     The aim of this study is to evaluate the effects of a partially supervised exercise program~     on different aspects of physical fitness, despite VO2peak, lung function, quality of life and~     sleep quality in children, adolescents and adults with Cystic Fibrosis.~   "
3681|NCT03518684|"~     Recent literature shows that birth injury is associated with postpartum pelvic floor~     dysfunction (pelvic organ prolapse and fecal and urinary incontinence). Prolonged labor,~     namely during the 2nd stage, is one of the main obstetric risk factors responsible for anal~     sphincter rupture and fecal incontinence. In addition, it is associated with increased~     maternal and neonatal morbidities including increased risk of lower genital tract~     lacerations. In an effort to shorten labor and decrease lower genital tract trauma many~     techniques have been investigated.~      The objective of our study is to investigate whether the use of obstetric gel shortens the~     first and second stage of labor and exerts a protective effect on the lower genital tract.~     Neonatal and maternal morbidities will be also assessed.~      The study design will be a randomized controlled trial of 2 groups, where the patients~     presenting for vaginal delivery will be randomly assigned to either:~        -  Group 1 who will receive the standard care during labor and delivery~        -  Group 2 who will receive the standard care during labor and delivery with the vaginal~          application of the obstetrical gel The goal of this randomized controlled study is to~          compare the length of the first and 2nd stage of labor and the lower genital tract~          integrity in the 2 groups of patients.~   "
3682|NCT03518671|"~     This study will evaluate whether a time-limited cognitive behavioral therapy (CBT)~     intervention in the post-treatment time period can address body image disturbance (BID) in~     patients with surgically-treated head and neck cancer (HNC), thereby improving BID and~     quality of life (QOL).~   "
3683|NCT03518658|"~     The purpose of this field evaluation is to collect and evaluate information related to~     CareLink transmission compliance as well as patient perceived benefit of BlueSync™ and the~     health care provider perception of the value of BlueSync™ and satisfaction with BlueSync™.~   "
3684|NCT03518645|"~     Study aim : To compare a novel strategy of lesion preparation with noncompliant balloons~     before implantation of BVS.~      Hypothesis: Predilatation with non-compliant balloons could facilitate optimal deployment of~     BVS. By achieving good scaffold apposition a need for post-dilatation could be significantly~     reduced. This is expected to result in better short- and long-term outcomes.~   "
3685|NCT03518632|"~     The aim of this study is to assess the impact of preoperative physical activity on physical~     capacities of patients undergoing liver resection for primary or secondary liver cancer.~   "
3686|NCT03518619|"~     The investigators propose to enhance our existing coping motive-specific normative feedback~     intervention (PFIcope intervention) by capitalizing on EMA/EMI technology to pair real-time~     affective monitoring with tailored real-time relapse prevention texts for individuals with~     anxiety and depression who drink to cope. The goals of the PFIcope+EMI study are to help~     individuals to identify motives for drinking and to utilize alternate coping strategies for~     negative affect in place of alcohol.~   "
3687|NCT03518606|"~     This is a phase I/II national, multicentre, multiple cohort, prospective open-label,~     non-randomised and non-comparative study, to evaluate the safety and activity of metronomic~     oral vinorelbine associated with durvalumab + tremelimumab combination immunotherapy for the~     treatment of advanced solid tumours.~   "
3688|NCT03518593|"~     This study evaluates the impact of additional cash and nutritional counselling on nutrition~     outcomes in pregnant women and children up to the age of two years in CT-OVC (cash transfer-~     orphan and vulnerable children) households in Kitui and Machakos counties of Kenya. The~     control arm households will receive their normal CT-OVC cash payment and the intervention arm~     will receive an additional cash payment and nutritional counselling.~   "
3689|NCT03518580|"~     This study aims to examine within-person variations of different contexts (time, physical,~     psychosocial and affective) of active life engagement, and how these variations predict a set~     of physiological indicators and health-related outcomes among community-dwelling older~     people. Specifically, this study has the following objectives.~      Objective 1: To investigate within-person variations in different contexts (i.e., time,~     physical, psychosocial, and affective) of active life engagement and interactions of these~     contexts.~      Objective 2: To examine how within-person variations in different contexts (i.e., time,~     physical, psychosocial, and affective) of active life engagement and interactions of these~     contexts may associate with a set of cardiovascular indicators measured on daily basis.~      Objective 3: To examine how within-person variations in different contexts (i.e., time,~     physical, psychosocial, and affective) of active life engagement and interactions of these~     contexts may associate with a set of health-related outcomes (e.g., physical functioning,~     depression, health-related quality of life).~   "
3690|NCT03518567|"~     This laboratory study will employ a multi-session experimental design to examine cue-induced~     craving for marijuana, the effect of marijuana administration (High THC) on behavioral~     economic demand for marijuana, and marijuana smoking topography. The study will recruit 100~     non-treatment seeking marijuana users who smoke marijuana at least twice weekly.~   "
3691|NCT03518554|"~     This is a phase 1, multi-center, dose escalation, open-label study to evaluate the safety,~     tolerability, pharmacokinetics, and preliminary evidence of antitumor activity of JAB-3068 in~     adult patients with advanced solid.~   "
3692|NCT03518541|"~     The study is designed to evaluate the use of electromagnetic tracking in transversal plane~     femoral derotation osteotomies. The goal is to raise the precision of the surgical procedure~     in order to improve the outcome in short- and long term. All patients are examined with an~     instrumented 3D gait analysis pre- and one year postoperatively. The electromagnetic tracking~     system is evaluated against a base line CT or MRI scan serving as reference standard pre- and~     postoperatively.~   "
3693|NCT03518528|"~     The purpose of this study is to compare pregnancy outcomes of frozen-thawed embryo transfer~     after endometrial preparation with vaginal estradiol or transdermal estradiol and to evaluate~     women's satisfaction~   "
3694|NCT03518515|"~     A randomized, clinical trial will be performed to assess changes in body weight and fat mass~     with daily potato consumption versus a calorie-matched snack of almonds.~   "
3695|NCT03518502|"~     Sorafenib is the standard therapy for hepatocellular carcinoma (HCC) with extrahepatic~     metastasis (EHM). However, addition of transarterial chemoembolization (TACE) may be~     beneficial for controlling intrahepatic tumour. The investigators aimed to compare the~     efficacy between the sorafenib monotherapy and TACE-sorafenib sequential therapy in HCC~     patients with EHM.~   "
3696|NCT03518489|"~     The purpose of this clinical study is to evaluate the efficacy of lappaconitine adhesive~     patch in alleviation radiation induced mucositis pain and the improvements in QOL of patients~     with nasopharyngeal carcinoma . To determine if lappaconitine administered prior to radiation~     therapy reduces the severity of radiation induced oral mucositis pain in patients who have~     been diagnosed with nasopharyngeal carcinoma.~   "
3697|NCT03518476|"~     In Qatar, tobacco use is one of the main causes of premature deaths and preventable diseases.~     As per the 2013 Global Adult Tobacco Survey (GATS), 12.1% of adults and 20.2% of men in Qatar~     smoke tobacco, and 55.4% of this smoke an average of 16 cigarettes or more per day. Moreover,~     15.7% of school students aged 13 to 15 years currently use some form of tobacco according to~     the 2013 Global Youth Tobacco Survey (GYTS). In Qatar, tobacco-related diseases including~     cardiovascular diseases and cancers are highly prevalent. In an effort to reduce tobacco use,~     Qatar has ratified the WHO Framework Convention on Tobacco Control (FCTC) and has implemented~     many tobacco control initiatives. In spite of these measures, tobacco use is still rising in~     Qatar. Pharmacists practicing in retail/community pharmacy are often the first port of call~     for individuals requiring health advice in general. Evidence has proven that they have a~     pivotal role in health promotion and disease prevention including tobacco cessation. Hence,~     pharmacists have excellent opportunities to reduce tobacco use in Qatar. Yet, ambulatory and~     community pharmacists in Qatar are not sufficiently contributing to tobacco control. Based on~     published data, only 21% of community pharmacists in Qatar always or most of the time ask~     patients about their smoking status. Furthermore, when asked about their smoking cessation~     training, 89% of pharmacists did not receive any kind of education or training about smoking~     cessation counseling in the past. In an effort to build the capacity of pharmacists in Qatar,~     the aim of the proposed study is to design, implement and evaluate an intensive education~     program on tobacco treatment for pharmacists in Qatar. The study will be a prospective~     randomized controlled trial comparing the effectiveness of the education program on~     pharmacists' tobacco cessation-related knowledge, attitudes, self-efficacy, and skills.~   "
3698|NCT03518463|"~     Caesarean section (CS) constitutes a large proportion of the total surgical volume in~     low-income countries. This rate comes with challenges including surgical complications,~     shortage of beds, and consequently long waiting time for operations and high costs. These~     have led to the adoption of ERAS in developed countries in a bid to save costs by reducing~     hospital length of stay without compromising the health of the mother and her baby.~   "
3699|NCT03518450|"~     The objective of this trial is to compare the efficacy of three different nerve blocks as an~     analgesic option after total knee arthroplasty (TKA), based on muscle strength, mobilization~     and pain.~      The Adductor Canal Block has been proposed as an equally effective technique to the Femoral~     Nerve Block in terms of pain control after a TKA, with the benefit of preserving muscle~     function. We hypothesize that a block performed at the apex of the femoral triangle would~     best balance analgesia with quadriceps function.~   "
3700|NCT03518437|"~     The investigator prospectively enroll 30,000 outpatients who were suspected of coronary~     artery disease (CAD) and underwent cardiac computed tomography angiography (CTA). The~     endpoint was major adverse cardiac events (MACE).The investigator aim to evaluate the~     prognostic value of CTA, risk factors and bio-markers for MACE.~   "
3701|NCT03518424|"~     The aim of the present study is to establish the injury incidence, severity and burden~     typically observed within Scottish professional football clubs. In line with the~     well-established model of sports injury prevention research proffered by van Mechelen, the~     first stage in this process is establishing the extent of the problem i.e. injury incidence,~     severity and burden. Such a multi-club study has never been conducted within Scotland despite~     a thriving professional game.~   "
3703|NCT03518398|"~     Meibomian gland dysfunction (MGD) is one of the most common causes of dry eye diseases. Over~     the past decade, several treatment options in MGD have been extensively studied including~     warm compression, lid hygiene, ocular lubricants, forceful expression, LipiFlow thermal~     pulsation system, intraductal probing, debridement scaling and intense pulsed light (IPL).~     IPL is a broad spectrum, non-coherent and polychromatic light source with a wavelength~     spectrum of 500-1200 nm. It can be filtered to allow only a range of wavelengths to be~     emitted. Different wavelength makes different depth of tissue to absorb a specific light~     energy. Intense pulsed light (IPL) has been widely used in dermatology as a therapeutic tool~     for removal of hypertrichosis, benign cavernous hemangioma, benign venous malformations,~     telangiectasia, port-wine stain and pigmented lesions. Concurrent ocular surface improvements~     have been observed in patients undergone IPL treatment. Very few prospective clinical trials~     showed that subjective dry eye symptoms decreased and some of the dry eye signs also~     improved. Nonetheless, there is still inconsistency in the efficacy of IPL among these~     studies. Biomarkers, specifically cytokines, in dry eye diseases have been studied to some~     extent. Moreover, the change in ocular surface inflammatory cytokines in patients with MGD~     after IPL treatment is unclear.~      The investigators proposed a prospective randomized double-masked sham-controlled clinical~     trial to investigate the efficacy and safety of intense pulse light in MGD patients.~   "
3704|NCT03518385|"~     Does the presence of intracavitary fluid during hormonal stimulation for IVF depends on the~     position of C-section-scar ?~   "
3705|NCT03518372|"~     Myocardial injury after non-cardiac surgery (MINS) is common in patients undergoing major~     surgery. Many of the events are undetected and associated with a high 30-day mortality risk.~     Knowledge of which perioperative factors that predicts MINS is lacking. Decrease in tissue~     oxygenation (StO2) is common in patients undergoing major spine surgery and is associated~     with postoperative complications in these patients. However, an association between decrease~     in tissue oxygenation and MINS has not been examined. This group of patients may have other~     potential predictors of postoperative complications that the study group would like to~     investigate. In this observational cohort study, we will include 70 patients undergoing major~     spine surgery at University of California San Francisco. The primary hypothesis is that~     decrease in intraoperative tissue oxygenation is associated with postoperative myocardial~     injury.~   "
3706|NCT03518359|"~     Burnout and overwhelming stress are growing issues in medicine and are associated with mental~     illness, performance deficits and diminished patient care. Among surgical trainees, high~     dispositional mindfulness decreases these risks by 75% or more, and formal mindfulness~     training has been shown feasible and acceptable. In other high-stress populations formal~     mindfulness training has improved well-being, stress, cognition and performance, yet the~     ability of such training to mitigate stress and burnout across medical specialties, or to~     affect improvements in the cognition and performance of physicians, remains unknown. To~     address these gaps and thereby promote the wider adoption of contemplative practices within~     medical training, investigators have developed Enhanced Stress Resilience Training, a~     modified form of MBSR - streamlined, tailored and contextualized for physicians and trainees.~     Investigators propose to test Enhanced Stress Resilience Training (ESRT), versus active~     control and residency-as-usual, in mixed-specialty interns (from Emergency Medicine, Internal~     Medicine, Pediatrics, Family Practice, OBGYN and Surgery Departments) evaluated for~     well-being, cognition and performance changes at baseline, post-intervention and three or~     six-month follow-up.~   "
3707|NCT03518346|"~     To evaluate the impact of using virtual reality, VR, game playing on successful completion~     and reduction of distress and pain in pediatric venipuncture, and to increase adherence in~     obtaining the desired blood volume.~   "
3708|NCT03518333|"~     This clinical study is designed to investigate the safety and potential ability of relocated~     autologous SVF (stromal vascular fraction) to restore erectile function in men with ED~     (erectile dysfunction).~   "
3709|NCT03518320|"~     The purpose of this study is to determine if TAR-200, an investigational drug delivery~     system, in combination with nivolumab is safe and tolerable in patients with muscle-invasive~     bladder cancer (MIBC) who are scheduled for radical cystectomy (RC) during an 84-day dosing~     cycle induction period comprised of four consecutive 21-day dosing cycles.~   "
3710|NCT03518307|"~     The aim of this work is to study demographic, clinical, management (diagnostic and~     therapeutic) and survival data concerning patients with Merkel's carcinoma in the Lower~     Rhine, thus obtaining the first French data.~   "
3711|NCT03518294|"~     Nonalcoholic fatty liver disease (NAFLD) is the leading cause of chronic liver disease in the~     United States. The most advanced forms of NAFLD are associated with increased liver-related~     mortality and lower overall survival. The current standard of care for NAFLD is lifestyle~     changes through diet and exercise. The human genome and regulation of gene expression is~     influenced by physical activity. NAFLD is a prothrombotic state with derangements in all~     three phases of hemostasis leading to clinically important clotting events. Exercise can~     improve coagulation in healthy persons. In this proposal, we seek to begin a line of work to~     answer the question Can lifestyle changes effectively mitigate the increased risk of~     clotting in patients with NAFLD? focusing initially on the at-risk population genetically~     susceptible to advanced disease.~   "
3712|NCT03518281|"~     Upper respiratory tract infections cause cold and flu-like symptoms and are the most common~     form of acute illness. Certain populations are at increased risk of upper respiratory tract~     infections including athletes who train at a high level of intensity for prolonged periods of~     time. Consequently, some athletes experience higher rates of cold and flu-like symptoms than~     the general population.~      Euglena gracilis is a micro-algae which can synthesize many nutrients necessary for human~     health, including insoluble beta glucan. Thus, intake of whole cell Euglena may be beneficial~     to athletes by providing essential vitamins to optimize immune function.~   "
3713|NCT03518268|"~     This study evaluates the efficacy of the probiotic food supplement Vivomixx in the prevention~     of bone loss occurring in post menopausal women with breast cancer treated with an aromatase~     inhibitor. Half of the participants will receive Vivomixx while the other half will receive a~     placebo. The primary endpoint is to assess changes of bone turnover markers during the period~     of 6 months.~   "
3714|NCT03518255|"~     Randomized clinical trial about the evaluation of the use of nature photographs in the~     positive and negative affects of oncological patients.~   "
3715|NCT03518242|"~     The investigators hypothesize that a regimen of three widely available, generic and minimally~     toxic antineoplastic agents (CMF) will result in improved patient adherence and relatively~     low toxicity for hormone receptor-positive Ugandan women with locally advanced breast cancer.~   "
3716|NCT03518229|"~     This project will pilot test whether a wearable device that tracks sun exposure and provides~     alerts regarding sun exposure and protection behaviors will reduce sunburns in melanoma~     survivors. The use of wearable technology devices has grown quickly over the last decade and~     studies using these devices to promote physical activity and weight loss have been promising.~     The investigators will pilot test the technology device versus a similar control device in 80~     melanoma survivors and compare sunburns between the two groups after the three month~     intervention.~   "
3717|NCT03518216|"~     Complex functional abdominal pain disorders (FAPD) with co-occurring anxiety are highly~     prevalent in children, can be very disabling, and are not responsive to currently available~     treatments. This research aims to better understand the neural mechanisms involved in a~     promising nonpharmacological treatment for FAPD to ultimately guide the development of more~     targeted treatment approaches for afflicted youth.~   "
3718|NCT03518203|"~     Hematopoietic stem cell transplantation (HCT)-associated thrombotic microangiopathy (TMA) is~     an understudied complication of HCT that significantly affects transplant related morbidity~     and mortality. The investigators hypothesize that early intervention with complement blocker~     eculizumab will double survival in HCT recipients with high risk TMA, as compared to~     historical untreated controls. An optimal eculizumab dosing schedule can be determined for~     this population through eculizumab pharmacokinetic/pharmacodynamic (PK/PD) testing.~   "
3719|NCT03518190|"~     The aim of this study is to demonstrate that infrared spectroscopy is able to detect pressure~     injuries at a very early stage~   "
3720|NCT03518177|"~     The recent years, the use of bronchoscopic lung volume reduction in emphysema patients~     instead of surgical operations has become widespread. Before this procedure, the~     implementation of Pulmonary Rehabilitation became a necessity. The inadequacy of the number~     of Pulmonary Rehabilitation Centers in our country and in our city and the increasing number~     of mentioned operations have increased the need for different exercise program applications.~     Prior to valve and coil applications in our study, changes in clinical conditions of patients~     will be examined if Pulmonary Rehabilitation is performed at home or in a hospital.~   "
3721|NCT03518164|"~     Anterior cervical discectomy and fusion (ACDF) is a surgery performed from the front of the~     neck in which damaged discs are removed and a bone graft is inserted into the space to allow~     the bone to grow together to set up a bridge or fusion between the bones of the spine. The~     purpose of this study is to determine whether there is an advantage to using autograft (bone~     material taken from the patient's own hip) or allograft (bone material derived from other~     sources) when performing ACDF. Both of these materials are routinely used by surgeons in ACDF~     surgeries. Neither is experimental.~      Subjects who participate in this study will be randomized to receive either allograft or~     autograft bone for the surgery. They will receive the 2 level ACDF surgeries routinely~     employed by the surgeons. The same screw-plate fixation will be used for all subjects in the~     trial and the same allograft material will be used for all subjects who are randomized to the~     allograft arm of this study.~      A determination will be made as to whether there is a difference in fusion rates associated~     with the choice of either allograft bone or autograft bone based on the subjects' x-rays one~     year post surgery. The study will also determine whether there are differences in clinical~     and functional outcomes associated with the choice of bone graft as measured by~     patient-reported outcomes instruments collected. In addition, the study will examine whether~     there are differences in clinical and radiographic outcomes based on choice of bone graft for~     the subgroup of smokers participating in the study. Overall hospitalization costs will also~     be obtained and compared as an indication as to whether one method or the other may be~     superior from a financial standpoint.~   "
3722|NCT03518151|"~     This research project aims to help address a gap in understanding about the~     micro-environmental determinants of diet by exploring whether improving the placement of~     fresh and frozen fruit and vegetables and removing temptations of confectionary at checkouts~     in discount supermarkets influences the dietary behaviours of women aged 18-45 years and~     whether it is cost effective.~   "
3723|NCT03518138|"~     This is a Phase 2 proof-of-concept (POC) study designed to determine the effectiveness of~     Q-122 for the treatment of Vasomotor Symptoms (VMS) versus placebo. Participants who meet all~     eligibility criteria following the Screening/Run-In period will be randomized to 1 of 2~     treatment arms; blinded Q-122 or placebo for a period of 28 days. All participants will be~     followed for a 2-week, drug-free, follow-up period after their last dose of blinded~     Q-122/placebo before termination from the study.~   "
3724|NCT03518125|"~     This study is designed to assess the safety and ability of BioThrax and AV7909 anthrax~     vaccines to generate an immune response in adults ≥ 66 years of age in stable health in~     comparison to adults 18-50 years of age in stable health.~   "
3725|NCT03518112|"~     The goal of this clinical research study is to learn if blinatumomab given in combination~     with low-intensity chemotherapy can help to control Philadelphia chromosome-negative acute~     lymphoblastic leukemia (Ph-ALL).~      The safety and effectiveness of this combination will also be studied.~      This is an investigational study. Blinatumomab is FDA approved and commercially available for~     the treatment of other types of ALL. The chemotherapy used in this study is FDA approved and~     commercially available for the treatment of ALL. It is considered investigational to use~     blinatumomab in combination with chemotherapy to treat Ph- ALL.~      The study doctor can explain how the study drugs are designed to work.~      Up to 44 participants will be enrolled in this study. All will take part at MD Anderson.~   "
3781|NCT03517371|"~     Identifying effective ways to improve function, slow decline and reduce disability is a high~     priority for people living with Parkinson disease and other chronic conditions. Regular~     participation in walking is essential to reduce disability and enhance participation in~     preferred life activities. However, people with chronic conditions are often sedentary,~     contributing to greater disability. The goal of this work is to determine the benefits of a~     walking, walking enhancing exercises and cognitive-behavioral strategies delivered using~     mobile health technology for people with Parkinson disease over a sustained period of time.~   "
3726|NCT03518099|"~     The aim of the SURVIBIO study is to characterize acurate biomarkers for acute mesenteric~     ischemia, in particular at early stages.~      In the study, the development of biomarkers will be based on the analysis of human biological~     samples from patients and controls that will be conserved in our biological library. Samples~     will be analysed in the Laboratory for Vascular Translational Sciences (LVTS, Inserm U1148),~     in the Department of Biochemistry (Pr Puy, Dr Peoc'h), in Paris V university (Pr Gauguier),~     in Imperila College of London (Pr Dumas), in Jacques Monod Institute (Pr Camadro) and in~     Maastricht University Medical Center (Dr Lenaerts and Dr Ceulemans). The candidate markers~     will be determined according to an a priori method (form markers already described in the~     litterature) and with no a priori strategy using -omics methods.~   "
3727|NCT03518086|"~     The purpose of this study is to evaluate the safety and efficacy of Mirikizumab in~     participants with moderately to severely active ulcerative colitis (UC) who have had an~     inadequate response to, loss of response, or intolerant to conventional or biologic therapy~     for UC.~   "
3728|NCT03518073|"~     The purpose of this study is to evaluate the safety and efficacy of a study drug that targets~     an abnormal protein in the brain found in people with Alzheimer's Disease (AD).~   "
3729|NCT03518060|"~     This is a prospective, non‐interventional, single‐arm, multi‐center study aimed at gathering~     real‐world data on Juluca use in routine clinical care in Germany, to supplement clinical~     trial data to further improve/optimize care in HIV positive subjects in Germany.~     Approximately 250 virologically suppressed HIV positive subjects on stable antiretroviral~     therapy (ART) will be included in the study at the discretion of treating physician. Eligible~     subjects will be followed up for approximately 3 years and data will be collected during~     routine clinical care.~   "
3730|NCT03518047|"~     The purpose of this study is to assess the safety and efficacy of risankizumab compared to~     placebo in subjects with moderate to severe chronic plaque psoriasis in the Russian~     Federation.~   "
3731|NCT03518034|"~     This is a blinded and placebo-controlled study of topical testosterone replacement therapy~     (TRT) in symptomatic hypogonadal men with increased risk for cardiovascular (CV) disease.~   "
3732|NCT03518021|"~     This trial will compare the clinical response to intramuscular and intranasal naloxone in~     pre-hospital opioid overdoses. Objective of the study is to measure and evaluate clinical~     response (return of spontaneous respiration within 10 minutes of naloxone administration) to~     a new nasal naloxone formulation in real opioid overdoses in the pre-hospital environment.~     The aim is to demonstrate that intranasal administration of naloxone is not clinically~     inferior to intramuscular administration, which is now standard treatment of care.~   "
3733|NCT03517995|"~     The main purpose of this study is to see if Prostaphane is effective and can help reduce the~     progression of bladder cancer. Researchers also want to find out if Prostaphane is safe and~     tolerable, and to evaluate how Prostaphane works to reduce the progression of bladder cancer.~     This study will compare Prostaphane with a placebo to see if taking Prostaphane is better~     than taking a placebo. A placebo is a pill that looks like Prostaphane but has no drug or~     other active ingredients in it.~      The study will be presented to eligible patients by the patient's surgeon at the time when an~     appointment is made for cystoscopy for suspicion of bladder cancer (BC) or to confirm BC~     diagnosis.~   "
3734|NCT03517982|"~     The purpose of this observational study was to assess the safety and efficacy of generic~     mycophenolate mofetil in de novo renal transplant patients in Jordan where no visits or~     intervention(s) additional to the daily practice were performed.~   "
3735|NCT03517969|"~     This phase II trial studies how well ATR kinase inhibitor VX-970 and carboplatin with or~     without docetaxel works in treating participants with castration-resistant prostate cancer~     that has spread to other places in the body. ATR kinase inhibitor VX-970 may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as carboplatin and docetaxel, work in different ways to stop the growth of~     tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them~     from spreading. Giving ATR kinase inhibitor VX-970, carboplatin and docetaxel may work better~     in treating participants with metastatic castration-resistant prostate cancer.~   "
3736|NCT03517956|"~     The primary objective of this study is to determine the safety, tolerability, and maximum~     tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of rogaratinib in combination~     with copanlisib in patients with locally advanced or metastatic solid tumors that are~     mRNA-positive for at least one FGFR1-4 subtype.~      The secondary objectives of this study are to characterize the pharmacokinetics (PK) of~     rogaratinib and copanlisib alone or in combination, and to assess the anti-tumor efficacy of~     rogaratinib in combination with copanlisib locally advanced or metastatic solid tumors that~     are mRNA-positive for at least one FGFR1-4 subtype.~   "
3737|NCT03517943|"~     To evaluate the bioequivalence of one extended release combination (loratadine 5~     mg/pseudoephedrine sulfate 120 mg) tablet manufactured for Bayer HealthCare LLC by SAG~     Manufacturing, S.L.U. Madrid, Spain (test treatment) to the extended release combination~     (loratadine 5 mg/pseudoephedrine sulfate 120 mg) tablet manufactured for Bayer SA-NV by~     Schering- Plough Labo NV Heist (reference treatment) which is currently marketed in Europe.~   "
3738|NCT03517930|"~     To evaluate the bioequivalence of one extended release combination (loratadine 5~     mg/pseudoephedrine sulfate 120 mg) tablet manufactured for Bayer HealthCare LLC by SAG~     Manufacturing, S.L.U. Madrid, Spain (test treatment) to the extended release combination~     (loratadine 5 mg/pseudoephedrine sulfate 120 mg) tablet manufactured for Bayer SA-NV by~     Schering-Plough Labo NV Heist (reference treatment) which is currently marketed in Europe.~   "
3739|NCT03517917|"~     This study aims to collect matched donor tissue and blood to enable the development of a~     manufacturing process for potential immunotherapies.~   "
3782|NCT03517358|"~     This study will look at virologically suppression of patients with HIV who receive pharmacist~     or case management care.~   "
3783|NCT03517345|"~     In this study, it is aimed to evaluate whether the addition of prebiotics to patients'~     post-operative diets increases Roux-en-Y Gastric Bypass surgery effects. Half of the~     participants were randomized prebiotic with conventional yogurt, while the other half were~     randomized only conventional yogurt as a snack~   "
7076|NCT03474224|"~     In this prospective observational study investigators aim to search any relationship between~     the venous to arterial carbon dioxide gap and the time of percentage to adherence too a~     stroke volume guided protocol.~   "
3740|NCT03517904|"~     -  Prospective, randomized, controlled, multi-center study~        -  A total of 240 subjects with femoropopliteal artery disease will be included according~          to inclusion and exclusion criteria.~        -  Patients will be randomized in a 1:1 manner into IVUS-guided or angiography-guided~          intervention group.~        -  Second 1:1 randomization into dual antiplatelet therapy (aspirin + clopidogrel) or~          triple antiplatelet therapy (aspirin + clopidogrel + cilostazol) is optional~        -  All patients will be treated with drug-coated balloons (In.PACT Admiral) for~          femoropopliteal lesions.~        -  Bare metal self-expandable stents will be used in addition according to findings of IVUS~          or angiography such as severity of arterial dissection or residual stenosis.~        -  Patients will be followed clinically for 1 year after the procedure.~        -  Ankle-brachial index and Image study follow-up (Duplex US or CT angiography) will be~          performed at 1 year.~   "
3741|NCT03517891|"~     Childhood obesity is increasing, particularly among Hispanics. Rapid weight gain during~     childhood increases the risk of obesity in childhood and in adulthood, also increasing the~     risk of chronic diseases such as diabetes and hypertension. This can be prevented with~     interventions during early in life that address multiple risk factors associated with the~     early development of obesity. Therefore, the purpose of this study is to test an intervention~     to promote baby activation and improve their sleep patterns and feeding patterns from birth~     to 12 months of age. For this purpose, pregnant women participating in the Special Nutrition~     Women, Infants and Children (WIC) Program in Puerto Rico will be recruited and randomly~     assigned to the control group (usual care within the program) or to the WIC + group (usual~     care + intervention). The intervention will focus on age-appropriate physical activity for~     children, healthy sleep and limited time on the screen, healthy dietary patterns and growth~     monitoring. The content will be delivered with a multimedia approach (web platform, mobile~     messages and telephone follow-up). If successful, this intervention could be adopted by the~     WIC program in Puerto Rico to help prevent childhood obesity among its participants. This~     will help improve the health of minorities and eliminate health disparities among Hispanics~     and other at-risk groups.~   "
3742|NCT03517878|"~     The purpose of this early Phase 2 comparison trial is to evaluate the impact of community~     health worker (CHW) home visitors on pregnant women and their children in a rural setting in~     the rural Eastern Cape of South Africa. The intervention provided by the CHWs targets~     underweight children, mothers living with HIV (MLH), mothers using alcohol, and depressed~     mothers with the goal of supporting pregnant women to improve birth outcomes, decrease the~     number of children born with a low birthweight, and develop child caretaking skills over~     time. UCLA has identified and matched four areas surrounding primary health care clinics: two~     intervention areas in which this CHW program has been running for one year, and two control~     areas without the program. Mothers in the research area are followed for one year after~     giving birth.~   "
3743|NCT03517865|"~     The iPCD Cohort is a retrospective international cohort that assembles available datasets~     with clinical and diagnostic data from patients suffering from primary ciliary dyskinesia~     (PCD) worldwide, to answer pertinent questions on clinical phenotype, disease severity,~     prognosis and effect of treatments in patients with this rare multiorgan disease.~   "
3744|NCT03517852|"~     This study will investigate the tumor-associated vasculature of patients with peritoneal~     carcinomatosis, or cancer that spreads along the inner abdominal lining. The investigators~     will use a technology known as intravital microscopy (IVM) in order to visualize in real-time~     the tumor-associated vessels of peritoneal disease. The IVM observations may determine if an~     individual patient's tumor vessels would be amenable to receiving systemic therapy, based on~     the functionality of the vessels.~   "
3745|NCT03517839|"~     In our study, it was aimed to evaluate the effect of inspiratory muscle training on fear of~     movement due to dyspnea in COPD patients. Participants will be randomly assigned to two~     groups. Inspiratory muscle training in the training group will be administered at least 5~     days a week, 15 minutes twice a day, beginning at 30% of the MIP for 8 weeks. Patients will~     come to the control once a week, the MIP values will be re-measured and the new training~     intensity will be determined at 30% of the new value. For the control group, a fixed training~     session will be given for at least 5 days a week, 15 minutes twice a day, not exceeding 15%~     of the MIP for 8 weeks.~   "
3746|NCT03517826|"~     In our study, we aimed to evaluate the validity and reliability of the Turkish version of the~     Breathlessness Beliefs Questionnaire-BBQ in our study.~   "
3747|NCT03517813|"~     This is a single institution, prospective screening trial of women at high risk for~     developing breast cancer, enriched with women with suspicious lesions on breast MRI which~     have been recommended for biopsy.~      Primary Aim: Measure and compare the diagnostic performance of CESM, ABMR, and standard~     breast MRI, using the following performance measures: cancer detection rate (CDR), biopsy~     rate, and cancer yield of biopsy (also known as positive predictive value 3 or PPV3).~      Secondary Aims:~        1. Compare screening performance outcome measures of sensitivity, specificity, and area~          under the receiver operating characteristic curve (AUC) for CESM, ABMR, and standard~          breast MRI. This will determine the feasibility of each modality as an alternative to~          standard breast MRI and provide valuable pilot data for designing a larger clinical~          trial to evaluate non-inferiority of either or both modalities.~        2. Breast cancer characteristics (size, histologic subtype, node-positivity, AJCC stage)~          will be assessed in the overall cohort, and stratified by mode of detection for each~          modality(screen-detected versus interval).~   "
3748|NCT03517800|"~     Postpartum haemorrhage is the main cause of maternal mortality. The aim of investigators'~     study was to evaluate the practice of hemostatic surgery (arterial ligation, uterine~     compression or hysterectomy) when the embolization of uterine arteries wasn't be performed.~   "
3749|NCT03517787|"~     Aim of the current study is to evaluate the effect functional electrical stimulation and~     therapeutic exercise on traumatic spinal cord injured participants`skeletal muscle~     characteristics, sitting balance, lung function and quality of life.~   "
3784|NCT03517332|"~     This is a prospective, multi-center, blinded feasibility study. The objective of this study~     is to test the feasibility of the detection of tumor DNA of a variety of tumors in peripheral~     blood using a novel process for the detection of circulating tumor DNA (ctDNA).~   "
8180|NCT03459768|"~     The main purpose of the CoDISEN cohort study is to propose a model of prevention and care for~     HIV and viral hepatitis adapted to the needs of people who inject drugs (PWID) in Dakar,~     Senegal.~   "
3750|NCT03517774|"~     Adults with lower limb amputation undergo rehabilitation in order to learn how to effectively~     use a lower limb prosthesis. Unfortunately, the process of being fitted a prosthesis can be~     delayed due to resource constraints and manufacturing times, which delays the rehabilitation~     process and puts patients at higher risk for functional decline. Preliminary work by our team~     have shown that our 3D printing system, 3DPrintAbility Devices by NIA (http://niatech.org/),~     perform at the same level of efficacy as traditionally manufactured prosthetics, which~     suggests that a digital manufacturing tool-chain is a viable alternative and may be desirable~     given the time savings involved. In order to lead to improved processes related to prosthesis~     fitting for adult transtibial amputees, we want to assess the feasibility and acceptability~     of using 3DPrintAbility sockets in this population. Specifically, we want to determine if: 1)~     the 3D printing of transtibial prosthetic sockets can provide better quality prosthetic care~     in regards to cost, timeliness, and accessibility; 2) 3D printed sockets are equivalent in~     quality to standard thermoplastic preparatory sockets in regards to safety, fit, durability~     and comfort; and 3) whether a 3D scanning, design and printing process can be integrated into~     the workflow of current rehab centres. If successful, the findings from this work can provide~     an innovative approach for facilitating the fitting of a socket for adults with amputation~     might provide significant savings to the healthcare system by making the process more~     efficient while optimizing clinical outcomes by allowing patients to begin their~     rehabilitation sooner~   "
3751|NCT03517761|"~     The purpose of this study is to evaluate the effectiveness of using anterior approach through~     the posterior oropharynx for treating alar and transverse ligament injuries with bone marrow~     concentrate for patients with craniocervical junction (CCJ) instability.~   "
3752|NCT03517748|"~     This study is a multicentric, comparative, randomized, investigator-blinded, in parallel~     groups study to demonstrate the non-inferiority of DM05 in comparison with Optive™, in terms~     of cornea and conjunctiva staining (Oxford score) on patients with moderate to severe ocular~     dryness, after 35 days of treatment.~   "
3753|NCT03517735|"~     This study compares automated administration of propofol and remifentanil guided by the~     Bispectral index (BIS) versus manual administration for sedation after cardiac surgery.~   "
3754|NCT03517722|"~     The purpose of this study is to evaluate the efficacy of ustekinumab in participants with~     active systemic lupus erythematosus (SLE) who have not adequately responded to one or more~     standard of care treatments.~   "
3755|NCT03517709|"~     This research is being done to determine how home blood pressure monitoring, using a~     commercially available blood pressure monitor with the capability of transmitting readings to~     stroke doctors can help manage blood pressure in the optimal range after a stroke. High blood~     pressure is the leading risk factor for stroke. It is important to control high blood~     pressure after a stroke to prevent another one from happening. We will use the Withings Smart~     Blood Pressure Monitor for daily blood pressure measurements.~      Tracking of blood pressure measurements will be done via iPod Touch equipped with internet~     connectivity. We hope to learn if this method of managing blood pressure is more effective~     than the standard way of having patients visit primary care physicians (the control group for~     this study). We will also get feedback from participants who will receive the Withings Smart~     Blood Pressure Monitor about the ease of use and overall satisfaction with this blood~     pressure device. People 18-100 years old who have had a stroke in the past 6 months may join.~     You will be excluded from the study if you are pregnant or plan on becoming pregnant in the~     near future.~   "
3756|NCT03517696|"~     Membrane sweeping is a routine procedure in obstetrics in term patients. It has been shown to~     be effective in decreasing post term gestation and in increasing rate of spontaneous vaginal~     delivery when used in setting of induction of labor in nulliparous patients. The goal of this~     study is to determine if membranes sweeping in early labor is effective in improving delivery~     outcomes including decreasing rate of cesarean section.~   "
3757|NCT03517683|"~     Hypotension is the most common complication of neuraxial anesthesia in obstetric patients and~     its prevalence in cesarean section is about 50-90%. Maternal hypotension causes unpleasant~     symptoms such as nausea, vomiting, loss of consciousness, respiratory depression, and cardiac~     arrest. Hypotension may reduce placental perfusion and result in fetal acidosis and~     neurological injury. Several techniques have been proposed to prevent hypotension.~      The recommended spinal block height to ensure patient comfort for Cesarean delivery is T4-6.~     Clinically, it is desirable that the spread of local anesthetic through the cerebrospinal~     fluid (CSF) achieves a sensory level no higher than the T4 dermatome to avoid extensive~     sympathetic block. It is also important that the spinal block level be no lower than T6 to~     avoid patient discomfort during peritoneal manipulation and uterine exteriorization. The~     effect of injection speed on spread of spinal anesthesia is controversial. Several studies~     have demonstrated more extensive spread with faster injection while others report either~     greater spread with slower injection, or no difference. Slow injection of hyperbaric~     bupivacaine 10 mg over 60 and 120 sec has been shown to reduce the incidence and severity of~     hypotension during Cesarean delivery under spinal anesthesia.~   "
3758|NCT03517670|"~     The aim of this study is to evaluate the tolerance of intravenous milrinone combined to the~     current standard treatment for cerebral vasospasm following subarachnoid hemorrhage.~     Assessment of IV milrinone safety in this setting is mandatory before the conduction of a~     large study assessing its effectiveness.~   "
3769|NCT03517527|"~     OBJECTIVE This study aims to find out the effects of walking exercise training, which is~     given according to Transtheoretical Model (TTM), and follow-up on improving exercise behavior~     and metabolic control in type 2 diabetic patients.~      RESEARCH DESIGN AND METHODS The study was conducted as a pre-test, post-test experimental~     model with 76 intervention (INT) groups and 76 control (CON) groups adult type 2 diabetic~     patients providing the criteria of the study and followed-up by the diabetes polyclinic of~     Adıyaman Education and Research Hospital. Patient introduction form (PIF), TTM scales and~     pedometer were used to collect the data. TTM based training was given to the intervention~     group according to the patients' change stages at hospital 10 weeks once per every 2 weeks.~     PIF, TTM scales were applied after the training. PIF, TTM scales were applied to the groups 9~     months after the pre-test again.~   "
4393|NCT03509402|"~     The aim of this study is to clinically and radiographically compare the performance of short~     (6 mm-long) versus long (≥11 mm-long) dental implants placed in the interforaminal region of~     fully edentulous mandibles, supporting a screw-retained full-arch cantilever bridge.~   "
3759|NCT03517657|"~     The purpose of the study is to determine the best treatment for the arm that has been~     affected by a stroke. The investigators plan to determine if the arm affected by a stroke~     will improve with a combination of motor priming and motor training. Motor priming provides a~     warm up for the brain so that the brain and body will better respond to treatment. There are~     two types of priming in this study. One is called bilateral motor priming which involves~     using both hands. Bilateral priming requires that the individual make continuous wrist~     movements in a low-tech gadget called the Exsurgo primer, a piece of equipment in which each~     hand goes between two plates that are connected together so that the stronger wrist moves the~     weaker wrist in and out at the same time. The second type of priming includes use of low~     intensity stimulation for your affected arm. Understanding the benefits of priming will~     improve the efficacy of treatment for future patients with stroke. The investigators expect~     both groups to improve in arm function and impairment. The investigators expect the bilateral~     priming group will have more improvement. The study team anticipates enrolling approximately~     76 individuals with stroke at Northwestern University and Shirley Ryan AbilityLab into this~     study. Each participant will have 24 visits. Nine visits will be for evaluation and fifteen~     for therapy. Each visit will be two to three hours depending on the type of visit and tests~     being done. Participants who are eligible and want to participate in this study will be~     randomized (selected by chance) to one of the two groups. The possible groups are: 1)~     bilateral priming plus motor training and 2) electrical stimulation priming and motor~     training. Participants are not blinded. Evaluation sessions consist of three separate days of~     testing and will occur at three time points: (1) before treatment starts; (2) after treatment~     is completed; and (3) 8 weeks later (follow-up evaluation: visits 22-24). There are three~     motor assessments. The main test, Fugl Meyer Test of Motor function (FMUE) is a common test~     for movement of the arm after a stroke. Participants will also be tested on the Chedoke Arm~     and Hand Activity Index (CAHAI) and the Action Research Arm Test (ARAT). Finally, the~     Neuro-QOL (short form) will be administered. There is also an evaluation of cortical~     excitability using TMS. After a stroke, there is often an imbalance of excitability between~     the affected and less affected parts of the brain. The imbalance will be measured using~     Transcranial Magnetic Stimulation (TMS), a technique used in neurorehabilitation research.TMS~     will not be used for treatment. There will also be a grip termination evaluation. This test~     will determine how long it takes to relax the affected hand after gripping an object.~   "
3760|NCT03517644|"~     Research has shown that placebo effects contribute substantially to clinical outcomes. Recent~     evidence suggests that placebos remain effective even if they are openly described as~     placebos (so-called Open-Label Placebos). In this study, the investigators examine hope and~     expectations as components of open-label placebos in an experimental study investigating~     pain..~   "
3761|NCT03517631|"~     The purpose of the study is to evaluate the efficacy and safety of autologous CD34+ cells~     that stably express multiplexed shRNA to treat HIV infection.~   "
3762|NCT03517618|"~     Primary Objective:~      To determine disease control rate (DCR) of TS-1® in patients with heavily pre-treated~     metastatic colorectal cancer~      Secondary Objectives:~        -  To determine objective response rate (ORR)~        -  To determine time to progression (TTP)~        -  To determine overall survival (OS)~        -  To assess incidence of adverse events (AEs), serious adverse events (SAEs) [Safety and~          Tolerability]~   "
3763|NCT03517605|"~     Cardiac rehabilitation is fundamental in the treatment of patients undergoing cardiac surgery~     regarding the educational, physical exercise and quality of life dimensions. Considering the~     competences of Specialist Nurses in Rehabilitation Nursing and the current prevalence of risk~     factors associated with cardiovascular disease, it is essential to implement programs in this~     area.~      This study aims to assess the impact of Specialist Nurses in Rehabilitation Nursing~     interventions on a cardiac rehabilitation program during hospitalization (phase I) and 1~     month after cardiac surgery (phase II), in around 30 patients of both sexes, between 25 and~     64 years old, and according to the American Heart Association and the American Association of~     Cardiovascular and Pulmonary Rehabilitation, met the criteria for low or moderate risk, class~     B for participation and exercise supervision, absence of signs/symptoms after cardiac~     surgery, with a left ventricular ejection fraction greater than 40%. Supervised interventions~     were performed during hospitalization, pre- and post-cardiac surgery, and 1 month after~     hospital discharge. In phase II, a physical exercise program was fulfilled according to the~     norms of the American College of Sports Medicine, comprising 3 sessions of physical exercise~     per week lasting between 30 to 60 minutes, including heating, aerobic exercise, and~     recovery/stretching. Hemodynamic data (blood pressure, heart rate, peripheral oxygen~     saturation) and the Borg scale were recorded in the initial, intermediate and final periods~     of each session. The aerobic capacity was evaluated through the 6-Minute Walk Test and~     health-related quality of life using the Short Form Health Survey 36 (SF-36V2) questionnaire.~   "
3764|NCT03517592|"~     The main objective of this project is to test whether EMDR therapy is effective in reducing~     substance use and improving clinical and trauma-related symptoms in SUD patients with a~     history of psychological trauma.~   "
3765|NCT03517579|"~     The Collar Therapy Indicator (CoTI) (A device that is placed in collar around the neck~     resembling a turtle neck sweater collar with a wire and recording box) has been shown in a~     single small previously published experience to provide data regarding radioiodine exposure~     that correlates with conventional methods of measuring I-123 and I-131 uptakes after~     diagnostic dose administration and/or therapy for thyroid disorders. We hypothesize that the~     device's continuous measurement capability will permit more accurate estimates of radiation~     exposure to thyroid tissue than conventionally employed methods assessing fractional uptake~     at one or a few time points. It may also provide information about the extent of variability~     in the absorbed radiation dose among patients with thyroid cancer and hyperthyroidism. By~     providing more complete information about individual patient's exposures, it will facilitate~     more accurate estimation of the administered I-131 dose requirements for control of~     hyperthyroidism and thyroid remnant ablation while reducing the need for repeated visits to~     the clinic for dosimetry measurements. The aims of our project include the following: (1)To~     compare quantitative imaging-derived thyroid time activity curve to that obtained using the~     CoTI and to determine the extent to which there is variability in radiation dose predicted~     using conventional methods to that predicted from measurement of the full Time-Activity Curve~     (TAC).(2) Evaluate the uptake and clearance kinetics across the 5 patients in each category~     as proof of principle for a potential larger trial to investigate use of this device in~     optimizing the administered doses of radioactive iodine to achieve therapeutic goals while~     minimizing risks of comorbidities, such a post-radioiodine hypothyroidism in patients with~     Graves' disease.(3)Evaluate patient experience, convenience, and discomfort in using the CoTI~     device with a survey instrument.~   "
3766|NCT03517566|"~     The purpose of this study is to assess ZPL389 efficacy and safety in subjects with moderate~     to severe atopic dermatitis.~   "
3767|NCT03517553|"~     The investigators propose a pilot feasibility study to determine if exercise delivered by~     passive electrical muscle stimulation (EMS) in patients with end stage renal disease (ESRD)~     on hemodialysis improves physical fitness and insulin resistance, outcome markers associated~     with morbidity and mortality in this population.~   "
3768|NCT03517540|"~     The purpose of this study is to assess the safety, tolerability, and efficacy of a~     combination treatment of tropifexor (LJN452) and cenicriviroc (CVC) in adult patients with~     nonalcoholic steatohepatitis (NASH) and liver fibrosis.~   "
3780|NCT03517384|"~     The aim of the study is to study an english-language version of BDD-NET (Enander, et al.,~     2014; Enander, et al., 2016), an internet-based treatment for Body Dysmorphic Disorder, on a~     globally recruited sample. This is an uncontrolled pilot study where a within-subjects~     repeated measures design was used to assess the feasibility of conducting all aspects of the~     study remotely, including recruitment, assessment, and treatment delivery.~   "
3770|NCT03517514|"~     This is a dissertation study which is divided into three different studies in order to answer~     the main research question (Study 3). The primary aim of this research (dissertation) is to~     investigate all-cause 30-day hospital readmission using functional mobility (5mWT, 30STS,~     6MWT, TUG), psychosocial attributes (KCCQ-12, HADS, ESSI), adherence to home exercise~     program, participation in a supervised exercise program, and number of follow up checkups~     with physicians or advanced health providers of patients with Acute Decompensated Heart~     Failure (ADHF) diagnosis who were discharged from a tertiary teaching hospital.~      Study 1: What is the effect of acute physical therapy on functional ability in individuals~     admitted with ADHF? Study 2: What is the effect of acute physical therapy on psychosocial~     attributes in individuals admitted with ADHF? Study 3: Which factors such as functional~     mobility (5mWT, 30STS, 6MWT, TUG), psychosocial attributes (KCCQ-12, HADS, ESSI), adherence~     to home exercise program, participation in a supervised exercise program, and number of~     follow up checkups with physicians or advanced health providers predict all-cause 30-day~     hospital readmission in patients discharged from a tertiary, teaching hospital with ADHF~     diagnosis?~   "
3771|NCT03517501|"~     The purpose of the study is to evaluate if ART-123 given to patients who have severe sepsis~     can decrease mortality.~   "
3772|NCT03517488|"~     This is a Phase 1, multiple dose, ascending dose escalation study to define a MTD/RD and~     regimen of XmAb20717, to describe safety and tolerability, to assess PK and immunogenicity,~     and to preliminarily assess anti-tumor activity of XmAb20717 in subjects with selected~     advanced solid tumors.~   "
3773|NCT03517475|"~     The investigators will pilot test (N=100 caregivers of children ages 3-4 years) the effects~     of a caregiver supervision intervention on caregivers' supervision and children's injury~     frequency using a Randomized Controlled Trial (RCT) design. The control group will receive~     Services as Usual (SAU), and the treatment group will receive SAU+ SHS. The results will be~     used to support an R01 application to conduct a larger-scale RCT test of the program.~   "
3774|NCT03517462|"~     The DOLF Ocular Changes after Ivermectin study will investigate the kinetics of O. volvulus~     microfilaria (Mf) in the eye following treatment with ivermectin. The primary objective is to~     determine the proportion of participants with complete Mf clearance from the eye at 3 and 6~     months following treatment with ivermectin (IVM).~   "
3775|NCT03517449|"~     This is a study of pembrolizumab (MK-3475, KEYTRUDA®) in combination with lenvatinib (E7080)~     versus treatment of physician's choice (doxorubicin or paclitaxel) for the treatment of~     advanced endometrial cancer. Participants will be randomly assigned to receive either~     pembrolizumab and lenvatinib or treatment of physician's choice. The primary study hypothesis~     is that pembrolizumab in combination with lenvatinib prolongs progression free survival (PFS)~     and overall survival (OS) when compared to treatment of physician's choice.~   "
3776|NCT03517436|"~     To establish the safety and effectiveness of the Edwards CENTERA Transcatheter Heart Valve~     (THV) System in patients with symptomatic, severe, calcific aortic stenosis who are at~     intermediate operative risk for surgical aortic valve replacement (SAVR)~   "
3777|NCT03517423|"~     Brivaracetam (BRV) is a new antiepileptic drug approved in March 2016 by Health Canada for~     the adjunctive treatment of focal epilepsy in adults. Three phase III clinical trials have~     confirmed its efficacy with an acceptable adverse effects profile. While randomized~     controlled trials represent the gold standard in measuring intervention efficacy, the~     generalizability of these findings to usual clinical practice remains uncertain.~      The primary objective of this study is to evaluate the effectiveness of BRV as an adjunctive~     treatment in epilepsy. The secondary objective of this study is to evaluate the tolerability~     of BRV as an adjunctive treatment in epilepsy.~      This is a prospective and multicentre post-marketing observational study. All consecutive~     adult patients (i.e. aged at least 18 years) in whom BRV is introduced in participating~     medical centres, ambulatory or hospitalized, will be approached to participate in the study.~     We will exclude individuals with generalized epilepsy as well as those aged less than 18~     years, in order to respect current Health Canada indications. We will exclude individuals~     cognitively or physically unable to complete the study questionnaires.~      We will collect data from participants during three clinical visits with their regular~     treating physician. These will be the baseline visit, the 3-month visit (three months~     following the initiation of BRV), and the 6-month visit. At each visit, we will collect data~     on seizure type(s) and frequency. Study participants will also complete four questionnaires~     to measure irritability, anxiety, depression, and quality of life.~      There will be two primary study outcomes. These are: a) mean percent change in monthly~     seizure frequency; and b) proportion with at least a 50% decrease in seizure frequency. There~     will be several secondary study endpoints: a) mean change in irritability [measured using the~     Brief Irritability Test (BITe)]; b) mean change in generalised anxiety [measured using the~     Generalized Anxiety Disorder - 7 (GAD-7) scale]; c) mean change in depression [measured using~     the Neurological Disorders Depression Inventory (NDDI-E) scale]; d) mean change in quality of~     life [measured using the 7-item Quality of Life Inventory in Epilepsy-10 (QOLIE-10) scale];~     e) the proportion of individuals that are seizure free, and f) change in distribution of~     seizure types (e.g. focal with motor seizures, generalized absence). We will query for all~     adverse effects the participant may experience.~   "
3778|NCT03517410|"~     This study investigates the association between the duration of smart phone use and back pain~     and proprioception deficits in patients with chronic mechanical low back pain (CLBP).~      It is hypothesized that increased duration of smart phone use will be associated with~        1. Increased back pain as measured by the Visual Analogue Scale (VAS)~        2. Reduced proprioception acuity as indicated by increased angle of error of back~          repositioning as measured by isokinetic dynamometer.~   "
3779|NCT03517397|"~     Smoking prevalence rates are disproportionately high among individuals living below the~     poverty threshold, those living in rural areas, and Oklahomans. Nearly 1.3 million Oklahomans~     live in rural areas and the prevalence of poverty is elevated relative to the U.S. Our~     preliminary work has indicated that offering small escalating financial incentives for~     smoking abstinence (i.e., Contingency Management [CM]) dramatically increases short-term~     cessation rates among socioeconomically disadvantaged smokers when incentives are included as~     an adjunct to clinic-based smoking cessation treatment. However, other approaches are needed~     for socioeconomically disadvantaged individuals who are unable to attend clinic visits due to~     rural residence or other limitations. Internet and mobile phone-based CM approaches have been~     developed to reduce or eliminate the need for in-person visits. The goal of the current~     project is to improve upon existing mobile CM approaches by fully automating the process to~     make financial incentives interventions for smoking cessation feasible and accessible to~     individuals across the state. The aims of the proposed project are to 1) develop a fully~     automated, mobile phone-based CM approach to remotely verify smoking abstinence, confirm~     participant identity, and deliver financial incentives for smoking cessation, and 2) evaluate~     the feasibility and preliminary effectiveness of using fully automated mobile CM as an~     adjunct to telephone counseling and nicotine replacement therapy among 20 socioeconomically~     disadvantaged adults. The current project extends the scope of the parent study by increasing~     the reach of the CM approach to socioeconomically disadvantaged individuals who may be unable~     to attend in-person visits.~   "
3785|NCT03517319|"~     Study Design: Randomized Single Blind Study Objective: To determine the dose relationship of~     DWP 450 for finger flexor spasticity Subjects: 78 patients with upper extremity spasticity~     after CVA Inclusion criteria: Patient who have spasticity (MAS greater than 2 in finger~     flexors) Methods: Patients will be randomly assigned to one of 5 groups. Gp 1: placebo, Gp 2:~     15U, Gp 3: 30 U, Gp 4: 50 U, Gp 5: 75 U~   "
3786|NCT03517306|"~     The investigators investigate the utility of FDG PET/CT based radiomics in lung cancer,~     including diagnosis and prognosis.~   "
3787|NCT03517293|"~     AHA and ACSM recognize lack of exercise is a major risk factor for developing cardiovascular~     disease (CVD), and other CVD risk factors such as obesity. It is important to note that CVD~     is the sixth leading cause of death and children are more likely to be undiagnosed due to~     their age and lack of symptoms. Further, according to the CDC, over one-third of children and~     adolescents are overweight or obese and at increased risk of CVD. Although many programs for~     children aim to decrease CVD risks and obesity few, if any, programs begin the intervention~     during prenatal development. Our preliminary findings suggest that regular maternal exercise~     improves cardiovascular health (lower heart rate, increased heart rate variability),~     normalizes body fat composition, and improves nervous system and motor tone even after birth.~     Norepinephrine is essential for fetal development, influences many tissues (heart, nerve~     cells, skeletal muscle, and fat cells), and can stimulate growth factors. It is believed that~     exercise hormones, such as norepinephrine, released during maternal exercise influence these~     growth factors during development.~      The central hypothesis of this proposal is that regular maternal exercise during pregnancy~     will improve the health of offspring before and after birth as evidenced by lower resting~     heart rate, increasing heart rate variability improved neurological maturation, and decreased~     adiposity. We have three specific aims to test this hypothesis through the Enhanced Neonatal~     Health and Neonatal Cardiovascular Efficiency Developmentally (ENHANCED) by Mom project (IRB~     approved #12-002524). Aim 1 will establish the association between maternal exercise during~     pregnancy and the heart health of offspring before and after birth. Aim 2 will determine the~     relationship between modes of regular maternal exercise and neonate neurological and muscular~     maturation as this relates to health of the child after birth. Aim 3 will elucidate the~     influence of different modes of maternal exercise during pregnancy on fetal and infant body~     composition as this relates to risk of obesity and CVD disease. These studies will provide~     novel insight into how different types of maternal exercise during pregnancy influence the~     overall health of offspring. Furthermore, these findings may have significant implications on~     the public health as it may provide evidence of pregnancy as the earliest intervention for~     attenuating cardiovascular disease risk of children.~   "
3788|NCT03517280|"~     This study proposes to investigate the effect of treatment of neuroblastoma on nutritional~     status, assessed by body mass index (BMI) z score, and body composition evaluated by~     mid-upper arm circumference (MUAC), from diagnosis through 1-year post end of treatment. The~     study also aims to investigate the nutritional status and its role in toxicities, infection,~     survival rates, disease relapse, cost of care and readmission rates, as well as~     health-related quality of life. The study will take place in Sao Paolo in Brazil, where an~     estimated sample of 50 children with neuroblastoma will be recruited for the period of 2~     years.~   "
3789|NCT03517267|"~     Thyroid nodules are a very common clinical problem with prevalence of up to 68% in adults on~     high-resolution ultrasound .Ultrasound used in order to differentiate between benign and~     malignant lesion in the thyroid has shown sensitivity of 93.8% and specificity of 66% and US~     guided ( Fine needle aspiration ) FNA is known to be the test of choice in order to determine~     the nodules nature . Four to 6.5 % of all nodules are malignant .There are several guidelines~     that were suggested to help predict the risk stratification of thyroid nodules by ultrasound~     .~      The American Thyroid Association (ATA) is widely used as evaluation, clinical and ultrasound~     criteria for fine-needle aspiration biopsy and management of thyroid nodules. The recent ACR~     TIRADS is a reporting system for thyroid nodules on ultrasound proposed by the American~     College of Radiology (ACR) published april 2017 that uses a slightly different scoring system~     for recommendation for FNA of thyroid.~      The aim of this study is to validate TIRADS ACR 2017 risk stratification in the patient~     population in comparison to ATA risk stratification~   "
3790|NCT03517254|"~     After an Anterior Cruciate Ligament Reconstruction by surgery, the most important muscle of~     the knee, called quadriceps femoral, loses strength in more than 60% of cases, which if not~     corrected can progress to osteoarthritis in up to 80% of patients, compromising their quality~     of life.~      The main treatment for loss of muscle strength in these patients is rehabilitation which~     includes strength and endurance exercises.However, in some cases, amino acids such as~     Glutamine (Gln) have been employed as an aid to recover muscle strength, but the evidence on~     this topic is not consistent and is inconclusive. Therefore, the main purpose of this study~     is to investigate if the oral complementation with Glutamine in combination with strength and~     resistance training can improve the muscle strength of the quadriceps femoral in patients~     with anterior cruciate ligament reconstruction compared with those receiving a placebo after~     six weeks of intervention.~   "
3791|NCT03517241|"~     Research questions/hypotheses: About 15% of the population over 40 years of age are affected~     by diseases of the retina. Accurate measurement of the extent of visual field impairment is~     of highest importance for disease subtype diagnosis and severity classification. The current~     gold-standard approach for the assessment of macular sensitivity is microperimetry (MP) where~     the patient is asked to report whether or not visual stimuli presented at different positions~     within the visual field are detected. While this technique is a very straightforward approach~     and simple in its application, it is important to note that MP is psychophysical in nature~     and requires constantly high attentional performance of the patient throughout the~     examination period. As many patients suffering from retinal diseases are well over 65 years~     of age, they are unable to maintain such high levels of attention over longer periods and,~     thus, MP results may be biased. Retinotopic assessment using population receptive field (pRF)~     mapping based on functional magnetic resonance imaging (fMRI) offers an alternative by~     allowing for objective visual field testing, independent of patient performance. We have~     shown previously in healthy subjects that pRF allows for accurate detection of simulated~     central scotomata down to 2.35 degrees radius. Also, pilot data in patients with retinal~     scotomata showed strong correspondence between pRF and MP results, i.e. macular regions with~     reduced macular sensitivity and atrophy of outer retinal layers correlated well with pRF~     coverage maps showing reduced density of activated voxels. The aim of this project is to~     determine whether pRF mapping could serve as an alternative visual field testing method by:~     (1) assessing test-retest reproducibility of pRF and MP in clinical populations with stable~     retinal diseases (Stargardt disease, geographic atrophy) over a four-week period; (2)~     assessing visual field changes over a one-year period in patients suffering from acute~     retinal scotomata (branch retinal artery occlusions, full-thickness macular holes). All pRF~     mapping will be accompanied by MP measurements to allow for a direct comparison of the two~     techniques.~      Scientific/scholarly innovation/originality of the project: The present project applies a~     novel approach for linking retinal function assessed with MP and pRF mapping in a~     representative patient population with acute and chronic retinal diseases. The project seeks~     to contribute to best practice methods for using fMRI to assess macular dysfunction both for~     documentation of the natural course of the disease and during therapy in a study setting.~      Methods: fMRI uses pRF mapping to provide retinotopic data (pRF coverage maps) that are then~     correlated with the results of conventional ophthalmic testing including MP, visual acuity~     and contrast sensitivity testing, reading performance, optical coherence tomography and~     autofluorescence imaging.~   "
3792|NCT03517228|"~     The purpose of this study is to test a robotic uterine manipulator system called the Barakat~     Automated Uterine Manipulator (BAUM), which will assist the surgeon in moving and positioning~     the uterus during a hysterectomy. This new device will allow the surgeon to control the~     movements of the robotic arm directly instead of giving verbal instructions to a staff~     member. The BAUM has never been used during surgeries before this trial. Overall, the study~     goal is to determine whether the use of this robotic uterine manipulator system decreases~     time in the operating room while increasing patient safety.~   "
3793|NCT03517215|"~     Antibiotic resistant infections are expected to cause 10 million deaths worldwide by 2050,~     and exceed cancer deaths. Reducing antibiotic use can reduce resistance levels. Hospitals~     have now developed Antimicrobial Stewardship Programs that promote better use of antibiotics.~     However, 80% of antibiotics are prescribed in the community where stewardship programs do not~     exist. Antibiotics are often prescribed for coughs and colds, where it can be difficult to~     tell if these are cases of pneumonia or strep throat. Doctors may prescribe antibiotics `just~     in case' and patients may request antibiotics hoping to feel better faster. To help family~     doctors and patients, a team of infectious disease specialists, researchers and community~     family physicians have collaboratively developed an Antimicrobial Stewardship Program (ASP)~     for use in the community. Testing in 3 family medicine clinics is showing reduced antibiotic~     use. What is needed is a strategy to `scale' up this program province wide to reduce~     antibiotic use enough to reduce resistance levels, but how to do this is not known. Working~     with a community clinic network, this project will test two implementation strategies to~     inform how best to implement a Community-Based ASP.~   "
3794|NCT03517202|"~     Outpatient midurethral surgery is a frequent surgery. It is performed either under general~     anesthesia or neuraxial anesthesia. A frequent complication is postoperative urinary~     retention requiring urinary catheterization, which implies a higher infectious risk.~      We compared the complication rate after TVT surgery depending on the type of anesthesia.~   "
3795|NCT03517189|"~     Introduction: Aorta no-touch off-pump coronary artery bypass surgery (OPCAB) has been the~     recommended technique for treatment of patients with high-risk of neurological damage or~     stroke. However, the displacement of the heart to achieve suitable exposure for graft~     construction elicits hemodynamic changes, potentially requiring conversion to on-pump.~     Objective: The aim of this study is to evaluate the sequential changes of hemodynamic~     parameters in patients that undergo aorta no-touch OPCAB. Method: Patients that undergo aorta~     no-touch OPCAB will be evaluated. The FloTrac / PreSep / Vigileo ™ (Edwards Lifesciences)~     system will be used to continuously record heart rate (HR), mean arterial pressure (DBP),~     central venous pressure (CVP), continuous cardiac index, systolic volume , systolic volume~     variation (VVS) and central venous oxygen saturation (ScvO2). The parameters will be~     evaluated 5 min before, during and 5 min after each anastomosis (left anterior~     descending-LAD, posterior descending PD, marginal-OM and diagonal-Dg). Postoperative lactate~     will also be evaluated.~   "
3796|NCT03517176|"~     CEND-1, Gemicitabine and Nab-Paclitaxel for Pancreatic Ductal Adenocarcinoma~   "
3797|NCT03517163|"~     The purpose of this research study is to learn more about the outcomes of children who~     received an Autism Spectrum Disorder (ASD) diagnosis when they were toddlers. The study is~     interested in whether an early diagnosis can help children with their cognitive, language,~     social, and behavioral abilities.~   "
3798|NCT03517150|"~     This study evaluates the effectiveness of intraoral appliance in the treatment of obstructive~     sleep Apnea Syndrome in class III obese in comparison to an adjustable silicone appliance.~     Both treatments will be test by all of the participants and they will make the~     polysomnography exam to have the outcomes.~   "
3799|NCT03517137|"~     The main objective of this trial is to assess whether treatment adaptation based on a very~     early FDG-PET/CT results in improved efficacy while minimizing treatment toxicity in advanced~     stage Hodgkin Lymphoma (HL) patients treated with brentuximab vedotin (BV)-containing~     regimens.~   "
3800|NCT03517124|"~     This randomized clinical study aims to compare success and survival of two different ceramic~     tooth restoration materials. The hypothesis for the study is that fluoride treated zirconia~     will retain as good as lithium disilicate reinforced glass ceramic when cemented by the same~     resin cement.~      One group of patients will receive a restoration in fluoride treated zirconia, the other~     group will receive a restoration in reinforced glass ceramic. All restorations will be~     cemented in the same manner. At 3, 6, 12 and 24 months the participants will be examined.~   "
3801|NCT03517111|"~     The purpose of this study is to test if a parenting program can be used to prevent substance~     use among Latino youth and at the same time promote healthy eating. Pairs of 7th grade~     students and one of their parents will be enrolled in the study and randomly assigned to~     three groups: an existing parenting intervention focusing on substance use prevention (FPNG),~     the enhanced parenting intervention that also has nutrition content (FPNG+), and a comparison~     program focused on academic success. Only parents will attend intervention sessions. Data~     will be collected from the parent and their 7th grade student to see how these programs~     impacted substance use, nutrition, and parenting. The investigators hypothesize that families~     receiving the FPNG+ will have improved nutrition habits than the other conditions. Students~     in both FPNG and FPNG+ will have lower substance use rates as compared to the academic~     success program. In addition, the effects of parenting strategies and sociocultural factors~     on the FPNG and FPNG+ results will be studied.~   "
3802|NCT03517098|"~     As the world goes into the aging society, the number of total hip and total knee arthroplasty~     (THA and TKA) will increase fast. It's important to develop strategies to improve the quality~     of healthcare and get earlier recovery and better outcome for patients undergoing THA and~     TKA. Enhanced recovery after surgery (ERAS) pathways have been reported to promote faster~     recovery. A volatile anesthetic desflurane has characteristics of rapid metabolism with minor~     dependence on liver and kidney function, so we hypothesized that desflurane-based ERAS~     (D-ERAS) pathway could provide better recovery for patients undergoing primary THA or TKA.~      This trial is a prospective, open-labelled, randomized controlled trial that will test, for~     length of stay (LOS) in hospital, the superiority of D-ERAS pathway as compared with current~     clinical practice. A total of 604 patients undergoing primary THA or TKA will be randomized~     to allocate either D-ERAS pathway (D-ERAS group) or conventional care according to different~     participating center (non-ERAS group). The primary outcome is LOS in hospital. Secondary~     outcomes include Postoperative LOS, all-cause mortality by 30 days after operation,~     in-hospital complications, mobilization, postoperative pain evaluation, total in-hospital~     cost, and readmission rate by 30 days after discharge from the hospital.~   "
3803|NCT03517085|"~     The primary objective of the study is to determine the safety of single doses of DTX401,~     including the incidence of dose-limiting toxicities (DLTs) at each dose level.~   "
8414|NCT03456726|"~     This is a multicenter, open-label, Phase 2 study to assess the efficacy and safety of~     tazemetostat in participants with relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL)~     with EZH2 gene mutation.~   "
3804|NCT03517072|"~     The management of obesity is based on a multidisciplinary approach and justifies the use of~     surgery in patients with the most severe forms. Surgery for obesity or bariatric surgery~     generally allows rapid and significant weight loss however it is associated with significant~     risks, and its long-term results remain heterogeneous and unpredictable. Long-term data will~     clarify the role of different types of bariatric surgery in surgical strategy, improve~     patient information and identify predictors of failure in order to provide personalised and~     tailored surgery for each candidate .~   "
3805|NCT03517059|"~     Pilot study:~        -  Longitudinal follow up of the PRODY-GI cohort for parkinson's disease (PD)~        -  Observational study of upper and lower axial symptoms' occurence in 30 PD patients in on~          and off drug conditions, 30 aged matched control subjects and 10 control subjects with~          supra nuclear palsy~        -  Multi modal approach: functional MRI, clinical , ENT assessment, respiratory assessment,~          neuropsychological and gait evaluations~   "
3806|NCT03517046|"~     The purpose of this study is to assess the safety and efficacy of implanting bead-type~     autologous chondrocytes (CartiLife®) obtained by culturing expanded costal chondrocytes of~     the patient with a chondral defect in the knee. The patients will be assessed clinically~     using clinical, biochemical and IKDC (International Knee Documentation Committee) outcomes~     preoperatively as well as 4, 8, 24 and 48 weeks postoperatively to assess the relief of~     symptoms and joint function.~   "
3807|NCT03517033|"~     Subjects to compare the single dose bioavailability of Torrent's Nebivolol Tablets 20 mg and~     Bystolic®20 mg Tablets of Forest Pharmaceuticals Inc., USA. Dosing periods of studies were~     separated by a washout period of 11 days.~   "
3808|NCT03517020|"~     Subjects to compare the single dose bioavailability of Torrent's Nebivolol Tablets 20 mg and~     Bystolic 20 mg Tablets of Forest Pharmaceuticals Inc., USA. Dosing periods of studies were~     separated by a washout period of 11 days.~   "
3809|NCT03517007|"~     The objective of this study is to implement an opt-out protocol to guide appropriate~     de-escalation of antibiotics in qualifying patients. The protocol, determined over the course~     a year with the help of a large, well-rounded expert panel, will be used by pharmacists to~     recommend de-escalation of antibiotics to hospital providers. Providers can then decide~     whether or not to follow the recommendation in determining the best treatment pathway for his~     or her patient.~   "
3810|NCT03516994|"~     This study compares the effectiveness of two different approaches to advance care planning~     among older African Americans and older Whites living in the community. The two approaches~     are a structured approach with an advance care planning conversation led by a trained person~     using Respecting Choices (First Steps) and a patient-driven approach which includes a Five~     Wishes advance care planning form written in plain language. The study will determine which~     approach is more effective at increasing advance care planning within each racial group and~     reducing differences between the two groups in advance care planning.~   "
3811|NCT03516981|"~     This study will investigate the utility of biomarker-based triage for study participants with~     advanced non-small cell lung cancer (NSCLC) without prior systemic therapy. Study~     participants within groups defined by a biomarker-based classifier (gene expression profile~     [GEP] and tumor mutational burden [TMB]) will be randomized to receive pembrolizumab in~     combination with MK-4280 or lenvatinib. The primary hypotheses are as follows: In~     participants receiving pembrolizumab in combination with either MK-4280 or lenvatinib, the~     Objective Response Rate (ORR) will be 1) greater than 5% among participants with low GEP and~     low TMB, 2) greater than 20% among participants with low GEP and high TMB, 3) greater than~     20% among participants with high GEP and low TMB, and 4) greater than 45% among participants~     with high GEP and high TMB.~   "
3812|NCT03516968|"~     Childhood obesity prevalence is increasing and is a serious public health challenge. Indeed,~     according to INPES in 2006, overweight and obesity were affecting 18 % of French children~     between 3 and 17 years. 3 % of the boys and 4 % of the girls were classified as obese. Obese~     children are likely to develop chronic disease, starting at paediatric age, as cardiovascular~     or bone diseases, or type 2 diabetes.~      Vitamin D deficiency is recognized to play an essential role in bone metabolism and arterial~     hypertension and type 2 diabetes development.~      Obesity, in adults like in children, is associated with vitamin D deficiency. Common~     explanations for this low serum concentration of 25(OH)D in obese are the sequestration~     and/or the volumetric dilution of this lipid-soluble vitamin by adipose tissue. Therefore,~     obese population is at higher risk of developing cardiovascular and metabolic complications.~      The nutrition comity of French Pediatric Society (SFP) edit vitamin D supplementation~     recommendations (2012) for adolescents at risk of deficit: supplementation by trimestral~     loading dose of 80 000 to 100 000 UI of vitamin D. However, for obese patients, the deficit~     is difficult to cure with classical loading doses. It seems that these patients need higher~     dose of Vitamin D (two to three times higher). Likewise, the optimum scheme of administration~     (daily vs monthly) was never evaluated.~      Given new physiopathological data on pleiotropic role of vitamin D (on bone, cardiovascular~     system, adipose tissue) and in light of consequence of obesity on these systems, it seems~     essential to obtain data on vitamin deficit correction in obese children and adolescents and~     to evaluate bone status of these patients using modern imaging technics (high resolution~     peripheral quantitative computed tomography, HRpQCT).~      In this context, the OBEVIDOS study, randomised multi-centre prospective in 156 obese~     children and adolescent will allow us for :~        -  evaluate vitamin D correction effect by two scheme of administration~        -  establish an inventory of vitamin D status in this population~        -  Modeling and simulation of vitamin D concentration in obese children and adolescents~          using a mathematical PBPK model~        -  study, in a patient sub-group, the impact of vitamin D deficit and of obesity by itself~          on bone, by analysing bone micro-architecture~   "
3813|NCT03516955|"~     This study assessed the safety and efficacy of generic Rosuvastatin in reducing plasma low~     density lipoprotein (LDL) cholesterol in Lebanese adult patients (18 years or older) with~     dyslipidemia for both primary and secondary prevention based on their total cardiovascular~     risk. No visits or interventions, additional to the routine clinical practice, were requested~     or performed.~   "
3814|NCT03516942|"~     This research trial studies the financial burden in patients with stage I-III colon or rectal~     cancer who are undergoing treatment. Collecting data from patients about their cost and~     quality of life may help doctors to better understand the impact of cancer treatment on a~     patient?s employment and finances.~   "
3832|NCT03516708|"~     The purpose of this research study is to evaluate the combination of two drugs, epacadostat~     and pembrolizumab, when given with routine radiation therapy and chemotherapy (capecitabine~     and oxaliplatin) to treat rectal cancer before routine surgery is performed to remove the~     tumor. In the first part of the study, the investigators are looking at how the body~     processes epacadostat when given with radiation and chemotherapy (without pembrolizumab) and~     what types of side effects occur. In the second part of the study, the investigators are~     determining the best dose of epacadostat to given when it's given with pembrolizumab and~     radiation and chemotherapy. In the final part of the study, the investigators are studying~     how the cancer responds to the treatment regimen.~   "
3815|NCT03516929|"~     From our experience among Egyptian population in our institution, there is an increased~     prevalence of hidden subclinical peripheral artery disease along with carotid artery~     affection. Thus, increasing the risk of post-operative morbid complications.We aim to~     evaluate routine/ non-selective carotid and peripheral arterial screening in asymptomatic~     patients undergoing coronary artery bypass grafting in the Egyptian populationIt is a~     prospective, non-randomized, comparative study including two groups of patients. The study~     will start from the day of approval of the ethical committee. It will include 260 patients,~     on basis of all new comers. Patients will be examined and classified as high-risk group~     (ɳ = 130) or low-risk group (ɳ=130).~      All patients will have the routine preoperative investigations along with evaluation of~     extracranial carotid system by non-invasive carotid duplex and lower limb arterial system by~     non-invasive bilateral lower limb arterial duplex.~   "
3816|NCT03516916|"~     The formation of a colostomy following surgery for rectal cancer changes body image,~     challenges patient practical skills and threatens quality of life. As the oncological results~     have improved over the last decades the number of survivors from rectal cancer who have to~     adjust to a cancer free life in their own homes is increasing. To enable the identification~     of the patients with stoma-related reduced health-related Quality of life (HRQoL) in a quick~     and reliable way we recently developed the Colostomy Impact Score (CI-score) comprising 7~     items of stoma related factors with significant impact on HRQoL. The purpose of the present~     project is to perform an international validation of the CI-score and to demonstrate its~     applicability.~      The construct validity of the CI-score will be studied internationally on crosssectional~     cohorts of patients with permanent colostomy after abdominoperineal excision (APE) or~     Hartmann's procedure in Denmark, Sweden, Spain, the Netherlands, United Kingdom, Turkey,~     Brazil, Egypt, Russia, Lithuania, Israel, Portugal, South Africa, Australia and China. This~     will be done by testing the CI-score against five anchor questions stoma impact on HRQoL, the~     5 Level version og the EuroQol measuer (EQ-5D-5L) and version 3.0 of the Quality of Life~     Questionnaire from the European Organisation for Research and Treatment of Cancer (EORTC QLQ~     C30 questionnaire v3.0).~      The impact of the challenges related to having a stoma may vary with different demographic,~     socioeconomic and cultural factors. Supplementary data on stoma care, demographics and~     socioeconomic status will be gathered to study the impact of patient-related factors and~     cultural differences on HRQoL in rectal cancer survivors with an ostomy.~   "
3817|NCT03516903|"~     Prospective, randomized, double-blind, placebo-controlled, proof of concept study. Patients~     with first anterior wall STEMI will be randomized with 4±2 days after symptoms beginning to~     receive ddMTX-LDE at the dose of 40 mg/m2 IV or placebo-LDE weekly for 6 weeks. All study~     participants will additionally receive folic acid (5 mg po qd) once a week, one day after the~     study drug. The primary and main secondary endpoints will be analyzed by CMR 3±1 days and at~     90±7 days after randomization.~      Patients will undergo clinical and laboratory safety evaluations before each study drug~     administration and 90-day post-randomization. Safety evaluations will include assessment of~     adherence, side effects, safety laboratory tests, and existing medical conditions or planned~     procedures that might alter study drug dosing. These visits also include screening for the~     occurrence of clinical events of interest. An algorithm for drug suspension based on clinical~     and laboratory finding will be followed.~      Pre-specified unblinded interim analyses by an independent investigator will be developed~     when 20% and 50% of the inclusions are reached.~   "
3818|NCT03516890|"~     To investigate the best treatment for hepatocellular carcinoma rupture~   "
3819|NCT03516877|"~     Mounting evidence shows that burnout, a critical metric for dissatisfaction and distress, is~     a growing problem within medicine. Burnout is a syndrome associated with worse physician~     performance, patient outcomes, and hospital economics. Furthermore, investigators are coming~     to understand that burnout, diminished performance and the development of mental and physical~     illness are related. It has been proposed that chronic and overwhelming stress, in the~     absence of adequate coping skills, promotes performance deficits from surgical errors to poor~     professionalism due to the effects of stress on cognition.~      Notably, in small studies of physicians and other high-stress/high-performance groups~     mindfulness-based interventions have shown exceptional promise in improving burnout and~     distress symptoms, protecting cognition, and enhancing meaningfulness and satisfaction in~     work. Nevertheless, in spite of promising results in various populations the translation of~     mindfulness-based interventions to real-world settings has been slow.~      There is a paucity of quality research examining individually-based interventions, formal~     mindfulness training in physicians, or either of these things in the high stakes world of~     surgeons and anesthesiologists. To address these gaps, investigators have developed Enhanced~     Stress-Resilience Training (ESRT) based on Mindfulness-Based Stress Reduction (MBSR), but~     streamlined and tailored for surgeons and anesthesiologists. Investigators have administered~     a needs assessment and found almost 100 faculty interested in such training, and concluded~     beta-testing of the curriculum which allowed for further refinement of logistics, dose and~     delivery. Finally, to establish a baseline in both departments, investigators administered a~     comprehensive well-being survey which captures multiple facets of psychosocial well-being and~     will be used along with executive function testing and measures of performance to evaluate~     the efficacy of out training in a stepped-wedge trial of faculty surgeons and~     anesthesiologists at multiple UCSF hospital sites.~   "
3820|NCT03516864|"~     In Canada, the age-standardized prevalence of diabetes is on the rise (increasing from 3.3%~     in 1998/99 to 5.6% in 2008/2009 Public Health Agency of Canada (July 2011)) and is almost 1~     in 10 globally. One of the most devastating complications of diabetes is the loss of a limb,~     (also known as lower extremity amputation, or LEA) due to complications resulting from a~     diabetic foot ulcer (DFU). Diabetics have a lifetime risk of 15-25% of developing a DFU1,~     which can lead to significant decreases in the quality of life, limitations in mobility,~     function and independence, and increased chance of depression and anxiety. In addition,~     diabetics post-LEA have high rates of mortality, with 30% dying in the first year post LEA~     and 70% at 5 years (more than the lifetime risk of dying from cancers). What differentiates a~     DFU that heals and one that progresses to LEA is often the vascularity of the limb; the~     diabetic lower extremity often becomes ischemic due to the vascular sequelae that are a~     common complication of diabetes, which hampers wound closure and immune clearance of~     wound-associated infections. Understanding limb oxygenation can direct treatment of a DFU,~     which may require limb revascularization to heal.~   "
3833|NCT03516695|"~     This study is a non-interventional, observational, prospective and global patient data~     registry. The study will collect effectiveness and safety data from approximately 1000~     patients with liver cancers treated with TheraSphere® in a real life setting from multiple~     centers globally. The absorbed dose to tumor and normal tissue will be calculated using the~     Simplicit90Y™ software in the subgroup of hepatocellular carcinoma (HCC) patients.~   "
3834|NCT03516682|"~     This study will assess the impact of automated reminders for the 6 month and 12 month vaccine~     visits to increase vaccination in parents experiencing logistic barriers to vaccination.~   "
3821|NCT03516851|"~     Extracranial-intracranial arterial bypass, including anastomosis of the superficial temporal~     artery to the middle cerebral artery and indirect bypass, can help prevent further ischaemic~     attacks in patients with Moyamoya disease (MMD). However, there is no established standard~     for the selection of the recipient vessels. In most situations, surgeons choose the recipient~     vessels with their own experiences. Intraoperative Indocyanine green (ICG) angiography using~     Flow800 software and multimodal neuronavigation can be used to assess the real-time cerebral~     blood flow velocity and perfusion of local brain tissue for better selection of the recipient~     vessels. Thus the aim of this study is to to determine whether direct bypass surgery combined~     with multimodal neuronavigation is superior to traditional direct bypass procedure alone in~     adult ischemic MMD patients.~   "
3822|NCT03516838|"~     A clinical trial to evaluate a filling material (ACTIVA) and compare it to a traditional~     filling material (compomer) to restore decayed deciduous teeth in children~   "
3823|NCT03516825|"~     Music Neglect Training has been developed for patients with hemispatial neglect to improve~     their attention on the left side. The purpose of this study was to examine the immediate and~     carry-over effect of Musical Neglect Training on unilateral visual neglect. Standardized~     assessments (Albert's test and Line Bisection Test) were used to measure a range of visual~     field. A total of 6 musical exercises with tone bars which are aligned horizontally helped to~     improve attention and perception of the visual field on the left side.~   "
3824|NCT03516812|"~     This phase II trial studies how well testosterone enanthate and olaparib work in treating~     participants with prostate cancer that has progressed despite hormonal therapy. Hormonal~     therapy, such as leuprolide, may lessen the amount of male sex hormones made by the body. In~     patients that have developed progressive cancer in spite of standard hormonal treatment (i.e.~     castration-resistant prostate cancer), administering testosterone enanthate may result in~     regression of tumors by causing DNA damage in cancer cells that have adapted to low~     testosterone conditions. Olaparib may stop the growth of tumor cells by blocking some of the~     enzymes involved in repairing DNA damage. Therefore, giving testosterone enanthate and~     olaparib together may work better in treating castration-resistant prostate cancer by~     generating DNA damage that the cancer cell is unable to repair.~   "
3825|NCT03516799|"~     The aim of the study is to innovatively extend acupuncture research in adult oncology to~     adolescents and young adults (AYA) by piloting a tailored acupuncture protocol for pain~     management in AYA in the Children's Hospital of Philadelphia (CHOP's) Center for Integrative~     Health.~   "
3826|NCT03516786|"~     The aim of this prospective study is to evaluate the recovery after cesarean section in~     patients who will receive Quadratus Lumborum Block (QLB) as a part of multimodal analgesia~     using Postoperative quality of recovery scale.~   "
3827|NCT03516773|"~     A Randomized, active comparator, two-part, partial crossover design. The study is designed to~     assess the pharmacokinetics and pharmacodynamics of Entera's Oral PTH(1 - 34) [EB612] in~     adult patients with hypoparathyroidism. .~   "
3828|NCT03516760|"~     This dose-escalating phase I trial assesses for the first time the safety, the side effects~     and the harmlessness, as well as the therapeutical benefit of the new study drug GEM333 in~     patients with acute myeloid leukemia (AML). This AML was relapsed after previous therapy or~     was refractory to the standard therapy.~   "
3829|NCT03516747|"~     Identification and localization of pathological parathyroid gland before parathyroidectomy is~     traditionally done by a combination of two methods: ultrasound and sestamibi scan. The~     investigators would like to show that one exam that includes ultrasound and fine needle~     aspiration of the parathyroid gland for parathyroid hormone level is as accurate as the~     traditional method.~   "
3830|NCT03516734|"~     We designed a double-blind, community-based, cluster-randomized control trial which will test~     to establish novel evidence on the efficacy of iron-fortified lentil in improving body Fe~     status of non-pregnant adolescents in rural Mymensingh district of Bangladesh. Lentils will~     be fortified with iron in the lab setting at the Crop Development Center (CDC) of the~     University of Saskatchewan in Canada. There will be three lentils based dietary intervention~     arm in this efficacy trial. Arm 1 will be intervened with iron-fortified lentils, Arm 2 will~     be non-iron fortified lentils, and Arm 3 arm will be the usual intake of lentil (no~     additional lentil). Arm 2 will be served as a comparison group and arm 3 will be served as~     control group. A total of 420 adolescent girls (including 20% drop-outs) - aged 10 - 17y;~     non-smoking, not pregnant, not breastfeeding, and generally healthy will be included in each~     arm - a total of 1260 adolescent girls in all three arms. Participating adolescents will be~     served thick preparation of cooked lentils (37.5gm raw lentil) 5 days a week for 85 feeding~     days (around 4+months). Socio-demographic characteristics, household food security status,~     and adolescent food habits will be collected at baseline and endline data point. Furthermore,~     venous blood will be collected to measure adolescents' Fe status at baseline, midline, and~     endline for 85 feeding days (5 days a week)- approx. 4+ months. In addition, Ravens~     Progressive Matrices will be used for non-verbal measurement of the cognitive ability of~     advanced observation and thinking skills specific to capacity for analyzing and solving~     problems, abstract reasoning, and the ability to learn of the adolescents. Both descriptive~     and inferential statistics will be used for this study. Serum ferritin level and cognitive~     performance is the primary outcome. The trial expects that the supplemental Fe from the~     iron-fortified lentils will improve body Fe status and cognitive performance after~     controlling for baseline Fe status and dietary Fe intake in this group of adolescent girls.~     The secondary outcome is the participants' anthropometries. Considering the amount of plant~     protein from lentils that need to be consumed to for the study, it is expected to have~     significant improvement in growth of the participants which will lead to increased~     productivity.~   "
3831|NCT03516721|"~     A reduction in peak heart rate (HR) and suppressed HR response during exercise is highly~     prevalent in obese populations. This phenomenon is also known as chronotropic incompetence~     (CI). In adult obese individuals, CI is independently related to elevated risk for major~     adverse cardiovascular events and premature death. Despite the established association~     between CI and prognosis in adult populations, the prognostic relevance of CI in adolescents~     with obesity has however deserved no attention, but is important. CI during exercise testing~     may indicate various, yet undetected anomalies, such as altered blood catecholamine and/or~     potassium concentrations during exercise, structural myocardial abnormalities or ventricular~     stiffness, impaired baroreflex sensitivity and cardiovascular autonomic dysfunction,~     atherosclerosis, or cardiac electrophysiological anomalies, which all have been detected in~     obese children and adolescents. However, whether CI during exercise testing may be a~     sensitive and specific indicator for these anomalies in obese adolescents has not been~     studied yet. In addition, the exact physiology behind obesity and development of heart~     disease remains to be studied in greater detail in obese adolescents. In this project, we~     examine the prevalence of CI (during maximal cardiopulmonary exercise testing, CPET) in 60~     obese adolescents (aged 12-16 years) vs. 60 lean adolescents, and study the association~     between CI and changes in CPET parameters, lactate, catecholamine and potassium~     concentrations during CPET, biochemical variables, and cardiac electrophysiology (by ECG~     recording). In addition, the relation between CI and cardiac function (echocardiography) will~     be examined in a subgroup (29 lean and 29 obese) of these adolescents. In this regard, the~     diagnostic value of HR (responses) during maximal exercise testing will be clarified in obese~     adolescents, and the physiology behind the elevated risk for heart disease in obese~     adolescents can be explored.~   "
3880|NCT03516084|"~     Niraparib is a PARP inhibitor. The study is a 2:1 randomized, double-blind,~     placebo-controlled, multi-center,phase 3 study of ZL-2306 (niraparib) as maintenance therapy~     following first-line platinum-based chemotherapy in patients with extensive-stage disease~     small cell lung cancer (ED-SCLC) to evaluate the efficacy and safety.~   "
3835|NCT03516669|"~     Helicobacter pylori (H. pylori) is the most common chronic bacterial infection in humans. The~     prevalence of H. pylori is about 30~50% in the Western adult population. It is estimated that~     about 50% of people are infected with this bacterium in Taiwan. Many studies have shown that~     H. pylori is an important causal factor of chronic gastritis, peptic ulcer disease, gastric~     cancer and gastric lymphoma. The World Health Organization classified H. pylori as a Group 1~     carcinogen in 1994. Endoscopic examination is indicated to confirm the above diagnosis for~     patient with H. pylori infection. Eradication of H. pylori infection reduces the risk of~     gastric cancer and recurrence of peptic ulcer disease. However, the eradication rate of~     clarithromycin-based triple therapy has been declining in recent years, probably related to~     the increasing resistant rate to clarithromycin. Several strategies have been proposed to~     overcome the declining eradication rate, including (1) extending the treatment duration of~     triple therapy to 14 days; (2) the use of bismuth quadruple therapy which contains bismuth, a~     proton pump inhibitor, and two antibiotics (usually metronidazole and tetracycline); (3)~     non-bismuth quadruple therapy (concomitant therapy) which contains a proton pump inhibitor~     and three antibiotics (usually amoxicillin, metronidazole, and clarithromycin); (4)~     sequential therapy which contains a proton pump inhibitor (PPI) plus amoxicillin for five~     days, followed by a PPI plus clarithromycin and tinidazole for another five days. The~     investigators aim to evaluate the efficacy of Clarithromycin powder in the Intraluminal~     therapy for Helicobacter pylori infection while an endoscopic examination is performed.~   "
3836|NCT03516656|"~     The purpose of this study is to determine if weight-based heparin infusions at a rate of 10~     units/kg/hour are sufficient to maintain a target anti-Xa of 0.1-0.35 IU/mL for VTE~     prophylaxis in patients undergoing microvascular surgery. Additionally, a pilot protocol has~     been developed to titrate these heparin infusions to ensure patients have sufficient VTE~     prophylaxis. All patients will be enrolled in the observational arm of the study and receive~     anti-Xa level monitoring. Patients with out-of-range anti-Xa levels will cross over to the~     interventional arm of the study and receive real time heparin infusion dose adjustments per~     the pilot protocol. The primary outcome measured will be the percentage of patients with~     anti-Xa levels in the target range of 0.1-0.35 IU/mL while on a heparin infusion at 10~     units/kg/hour.~   "
3837|NCT03516643|"~     This is a prospective cohort study to examine the efficacy of ESMR application in patients~     with refractory angina despite optimal medical therapy, not suitable for further PCI or CABG.~     Characteristics such as angina class scores (CCS class score), nitroglycerin consumption and~     hospitalization were compared at baseline and 1, 6 and 12 months after ESMR therapy. The~     effect on cardiac perfusion was assessed at 6 months.~   "
3838|NCT03516630|"~     The present study has been designed to evaluate the effect of three doses of trazodone (20,~     60 and 140 mg), in comparison to placebo, on the QT/QTc interval of healthy volunteers.~     Trazodone oral drops 6% formulation has been selected in order to evaluate the three doses~     using the same formulation, because the lowest available strength for the tablet formulations~     is 50 mg. According to the E14 guideline on the evaluation of QT/QTc interval prolongation~     and proarrhythmic potential of antiarrhytmic drugs, a negative control (placebo) and a~     positive control (moxifloxacin) will also be assessed.~   "
3839|NCT03516617|"~     This phase II trials studies how well acalabrutinib with or without obinutuzumab works in~     treating participants with early-stage chronic lymphocytic leukemia or small lymphocytic~     lymphoma. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Monoclonal antibodies, such as obinutuzumab, may interfere with the~     ability of cancer cells to grow and spread. It is not yet known whether giving acalabrutinib~     with or without obinutuzumab will work better in treating participants with early-stage~     chronic lymphocytic leukemia or small lymphocytic lymphoma.~   "
3840|NCT03516604|"~     This study will test whether seven days administration of a serotonin receptor subtype 4~     (5HT4) agonist called PF-04995274 has positive effects on emotional processing and neural~     activity in unmedicated depressed patients compared to placebo. The study will also include a~     group of patients randomised to seven days administration of citalopram (20 mg), which is a~     standard treatment for depression.~   "
3841|NCT03516591|"~     An open label, Phase 1, study of AMV564 as monotherapy to assess the safety and efficacy in~     patients with Myelodysplastic Syndromes~   "
3842|NCT03516578|"~     The prognostic significance of cardiac magnetic resonance (CMR) derived parameters of~     myocardial and microvascular injury has not been fully elucidated yet in non-ST-Elevation~     myocardial infarction (NSTEMI) patients. In the present study the investigators aim to~     comprehensively investigate the prognostic significance of CMR in a prospective, multicentre~     registry cohort of NSTEMI patients undergoing early percutaneous coronary intervention (PCI).~     CMR will be performed within the first week following the index event. The primary endpoint~     is defined as a composite of death, reinfarction, and new congestive heart failure (major~     adverse cardiac events) at 12 months.~   "
3843|NCT03516565|"~     The aim of this study was to investigate salivary and gingival crevicular fluid (GCF) levels~     of MMP-8, MMP-9 and TIMP-1 during 2/3 trimester of pregnancy and after delivery~   "
3844|NCT03516552|"~     Although it has been pointed that estimates are significantly inexact and different from each~     other, the actual accuracy of them has not been properly investigated and compared.~   "
3845|NCT03516539|"~     Video laryngoscopy provides easily a good laryngeal view compared to direct laryngoscopy. It~     is particularly, useful in patients with anticipated difficult intubation, and also widely~     used for educational purposes. Among video laryngoscopy, Mcgrath is a recently-developed,~     portable video laryngoscopy with a liquid crystal display (LCD) monitor and disposable curved~     blade.~      Mcgrath is known to provide excellent laryngeal visibility even in case of~     anticipated-difficult and anticipated-unsuccessful intubation as well as normal airway~     management. However, compared with direct laryngoscopy, the success rate of intubation and~     the time required for anticipated difficult intubation have been reported conflicting results~     in previous studies. The aim of this study was to compare the intubation success rate, the~     intubation time and the ease of use with Mcgrath video laryngoscopy and direct laryngoscopy~     during intubation.~   "
3846|NCT03516526|"~     A prospective clinical trial with the aim of maintaining drug efficacy of natalizumab while~     extending dose intervals guided by drug concentrations in patients with relapsing remitting~     multiple sclerosis.~   "
3847|NCT03516513|"~     Problem Solving Therapy for Primary Care (PST-PC) is an evidence based psychosocial~     intervention (EBPI) for use in primary care settings, with more than 100 clinical trials.~      Despite it's proven efficacy we have found that implementation of PST-PC is complicated,~     resulting in rapid program drift (deviation from protocol with associated loss of efficacy),~     among practitioners following completion of training. Many studied have shown that program~     drift is not uncommon in the implementation of EBPIs and can be mitigated through on-going~     decision support and supervision. Unfortunately, decision support and supervisors of EBPIs~     are not widely available in low-resourced primary care clinics. We will address this problem~     by creating decision support tools to be integrated into electronic health records. Because~     these tools hare deemed by many practitioners in other field to be burdensome, we will~     explicitly involve active input on the content, design and function of these support tools.~     Outcomes may include electronic dashboards for panel management, automated suggestions for~     application of PST-PC elements based on patient reported outcomes or integration of automated~     patient tracking, and 4) support of patient engagement. We hypothesize that enhance decision~     support (target mechanism) will sustained quality delivery of PST-PC, which in turn will~     improve patient reported outcomes.~   "
3848|NCT03516500|"~     This is a protocol to determine the safety and feasibility of using Iron Sucrose Injection to~     identify the intersegmental plane,not only on the pleural surface but also the parenchyma of~     the lung.~   "
3849|NCT03516487|"~     This study will evaluate SYNB1618 (investigational product) in healthy volunteers (HV) and~     subjects diagnosed with phenylketonuria (PKU) for the possible treatment of PKU.~     Phenylketonuria (PKU) is a rare inherited metabolic disorder that occurs in people who are~     missing an enzyme that the body needs to use phenylalanine. Eligible subjects will receive~     investigational product (IP) in the clinic, and will undergo safety monitoring, evaluations~     and subsequent follow-up after IP administration.~   "
3850|NCT03516474|"~     In this study the investigators are testing a device that may help us tell how well the~     participants' wound is healing. This device is called the MIMOSA, and it shines different~     colours of light on the participants' skin. It will not touch the participants' skin, or~     change how the participants' wound is healing. The MIMOSA is designed to be used alongside~     the camera that is built into the participants' cell phone, and the investigators will use a~     cell phone to take a picture of the participants' skin. This picture will tell us how much~     oxygen is getting to the participants' wound, which can tell us more about how the~     participants are healing. The MIMOSA device is an experimental diagnostic tool, and will not~     influence how the participants' wound is healing.~   "
3851|NCT03516461|"~     Radiation enteritis is one of the most feared complications after abdominal or pelvic~     radiation therapy.The gut microbiota is considered to constitute a microbial organ which~     has pivotal roles in the intestinal diseases and body metabolism. Evidence from animal~     studies demonstrated the link between intestinal bacteria and radiation enteritis. This~     clinical trial aims to evaluate the efficacy and safety of selective microbiota~     transplantation (mini-FMT) for radiation enteritis.~   "
3852|NCT03516448|"~     This is a randomized, double-blinded, placebo-controlled, multi-center Clinical Trial.~     Patients with no tumor lesions 21 days after resection of hepatocellular carcinoma will be~     randomized in a 1:1 ratio to 1 of the 2 treatment groups：6mg/d Tyroserleutide (injection), or~     placebo~   "
3853|NCT03516435|"~     This experiment is expected to understand the benefits of different settings of electrical~     stimulation in the treatment of overactive bladder.~   "
3854|NCT03516422|"~     The initial step of wound management, debridement, is thought to be critical in promoting~     wound healing. Of the numerous debridement modalities, ultrasound seems to hold promising~     results in accelerate healing in our own clinical experience here at St. Michael's Hospital.~     In brief, ultrasound debridement is a method of removing devitalized tissue through~     microstreaming and cavitational effects. The non-thermal energy up-regulates cellular~     activity and promotes growth factor and protein synthesis, fibrinolysis, and is~     anti-bacterial . The technology selectively emulsifies dead and dying tissues with~     micro-sized gas bubbles, stimulates membranes of surrounding healthy cells, and renders~     bacteria more susceptible to antibiotic treatment. Thus, in addition to creating an optimal~     environment, the modality also serves to promote the process of healing. A systematic review~     and meta-analysis by Voigt et al. (2011) examined the use of low-frequency (20-30 kHz)~     ultrasound in randomized-controlled trials. It was found that low or high-intensity delivery~     of low-frequency ultrasound both promoted early healing in lower-extremity wounds. At St.~     Michael's Hospital, ultrasound debridement is already being used in the wound clinic with~     promising results. However, objective comparisons need to be made to validate our clinical~     observations. The goal of the proposed pilot study is to assess the feasibility of our~     current study design. The information gathered will allow us to refine the research~     methodology for the development of a larger-scale study.~   "
3855|NCT03516409|"~     Background: antibiotic-associated diarrhoea (AAD) is defined as an acute inflammation of the~     intestinal mucosa associated to the administration of antibiotics. Its aetiology seems to be~     linked to the impact of antibiotics on the normal digestive microbiota. Acute otitis media~     (AOM) is a common paediatric condition and it is one of the most commonly cited indication~     for antimicrobial therapy in children (amoxicillin + clavulanic acid).~      Treatment modalities for AAD are limited because no established treatment exists for~     non-Clostridium difficile associated AAD, except for discontinuing antibiotic therapy.~     Measures to prevent AAD include the use of probiotics. The rationale for the use of~     probiotics in AAD assumes that, considering the pathogenesis of AAD, AAD is associated with~     disturbance in the normal intestinal microbiota; administrating specific probiotic strains it~     is possible to normalize unbalanced indigenous microbiota.~      Scientific evidence suggests that prebiotics could be beneficial too. Prebiotics can act in~     synergy with probiotics, being efficacious in suppressing the growth of pathogenic bacteria~     that may occur during antibiotic therapy.~      Study rationale: the principal side effects of treatment with amoxicillin-clavulanate include~     diarrhoea, vomiting and allergic reactions. Aim of this study is to evaluate the~     effectiveness of the administration of a synbiotic product, Bio-Kult Infantis®, in the~     prevention of AAD during a standard therapy with amoxicillin-clavulanate to treat AOM.~      Objective: to evaluate the effectiveness of a synbiotic product in the prevention of~     Antibiotics-Associated Diarrhoea (AAD) during a concomitant standard therapy with amoxicillin~     / clavulanic acid, also known as co-amoxiclav, to treat Acute Otitis Media (AOM).~      Study design: this is a multicenter, double blind, parallel group, placebo controlled,~     randomized clinical study. 276 children 6 - 35 months old will be enrolled and then~     randomized into one of the two study groups (Bio-Kult Infantis® + co-amoxiclav standard~     treatment for AOM / placebo + co-amoxiclav standard treatment for AOM). A comparison will be~     performed to evaluate the effectiveness of a synbiotic product in the prevention of AAD~     during the concomitant standard therapy with co-amoxiclav.~      During the study 4 visits will have to be performed at the study centre, and extra visits~     will be performed in case of AOM relapse after recovery. The study will last for each patient~     38 ± 6 days.~   "
3881|NCT03516071|"~     This is a Phase 2, Open-label, Randomized, Multicenter Study to Investigate the Efficacy,~     Safety, and Pharmacokinetics of Brivanib in Patients with Previously Treated Advanced~     Hepatocellular Carcinoma.~   "
3856|NCT03516396|"~     Heifer Project International is a globally active NGO with more than 400 projects in over 30~     countries. The organization uses the introduction of livestock and related training in the~     development of social capital as tools for poverty alleviation, citizen empowerment, and~     community development. In a pilot project conducted in 2009-2012, these activities were found~     to promote some improvement in child health and nutritional status. However, robust~     enhancement of these important indicators was not observed. Heifer now intends to investigate~     the efficacy of a nutrition and child health education program in amplifying these effects.~   "
3857|NCT03516383|"~     The purpose of this study is to predict the outcome of peripheral revascularization surgery~     by use of a new technology developed by our team, Pulse Wave Velocity imaging (PWVI), which~     has the capability to detect pulse transit time (PTT), and pulse wave velocity (PWV). This~     PWVI will be compared against known gold standards pre and post lower extremity limb~     revascularization and used to evaluate outcomes. Specifically, is leg PWV different among~     those with or without PAD, and is leg PWV different among those who undergo revascularization~     surgery and those who do not? This study represents the first clinical pilot study of the~     device with the aim to expand study participant numbers in future research and to eventually~     develop a PAD screening tool. This would be the first of its kind ever described.~   "
3858|NCT03516370|"~     This study was carried out in the Department of Periodontology and source of patient was be~     from the outpatient section of Tatyasaheb Kore Dental College & Research Centre, New Pargaon.~     Study included the 31 patients with chronic periodontitis, with age group between 35-60~     years, two interdental suprabony pockets with 5-8mm pocket depth in two different quadrants~     were chosen as the test site (TS) and control sites (CS). In control sites, only SRP was~     performed followed by placement of placebo distilled water. In test sites, SRP was followed~     by placement of Lyophilized saccharomyces boulardii in the pocket. S. boulardii will be~     delivered subgingivally by by mixing 1gm of sachet containing 250mg of lyophilized yeast with~     0.5ml of distilled water this prepared paste was injected in the perio pocket with luer lock~     syringe and cannula .The subgingival plaque samples were collected at baseline, 4th day, 4~     week for detection of p. gingivalis for microbiological analysis and clinical parameters~     wiere recorded at baseline and at 1 month.~   "
3859|NCT03516357|"~     Effects on Ocular Parameters of Myopic Eyes After Orthokeratology in Myopic Children~   "
3860|NCT03516344|"~     Since osteopathy it is considered that the alterations in the mobility of the different~     structures of the organism could cause a decrease in the blood circulation of the tissue~     causing a functional disorder and, with time, the appearance of a disease.~      In visceral osteopathy, the treatment of liver dysfunctions it is important due to their~     interrelation with the functioning of the rest of the abdominal and pelvic viscera and,~     especially, through the hepatic portal system. However, there are few studies showing whether~     a manual therapeutic intervention can affect the mobility, function or vascularization of a~     viscera.~      Ultrasonography is an appropriate tool for validating some of these intervention procedures~     given their safety, repeatability, autonomy and the low cost of the procedures and technical~     equipment which, in a non-invasive manner, will allow the effects of the different~     therapeutic interventions to be verified.~      Hypothesis:~        1. Vertebral manipulations and pumping of the liver improve the flow of the portal vein in~          front of the diaphragmatic breathing and the contraction of the psoas iliac muscle.~        2. The accuracy of ultrasound to assess venous flow may be useful as an outcome measure.~      Objectives: To describe the immediate changes of different manipulative interventions on~     portal vein flow in healthy women and to obtain baseline measurements for future research.~      Sample description: Pilot randomized controlled clinical trial with a sample of 50 healthy~     adult women recruited intentionally sampled that will be pseudo-randomly forcing equality of~     groups: control, chest manipulation, liver manipulation, abdominal breathing and iliac psoas~     muscle contraction.~      The minimum size required has been calculated using the program G*Power 3.1.3 for Windows~     (Universität Kiel, Germany, 2008) based on an effect size of 0.5, type I error of 5%,type II~     error of 10% and an effect size of f=0.45.~   "
3861|NCT03516331|"~     This is an 2-part study. Part 1 will assess the safety, tolerability and pharmacokinetics of~     single doses of FDL176 with and without co-administration of FDL169. Part 2 will assess the~     safety, tolerability and pharmacokinetics of repeated doses of FDL176 with and without~     co-administration of FDL169 .~   "
3862|NCT03516318|"~     A randomized control trial to test the effectiveness of a structured online support group,~     SMART (Social Media to improve ART Retention in Treatment) Connections, to improve retention~     in HIV care services among youth living with HIV (YLHIV) in Nigeria.~   "
3863|NCT03516305|"~     This is an open-label, non-randomized, single dose, pharmacokinetic study in 36 healthy adult~     male and female volunteers, including 18 smokers and 18 non-smokers. All subjects will be~     administered a single inhaled dose of Staccato alprazolam 1 mg via hand-held inhaler. Blood~     samples will be drawn for pharmacokinetic analysis. Eligible subjects are admitted to Phase 1~     unit for up to 48 hours. Subjects will receive a post-study safety phone call 14 days(± 2~     days) after dosing.~   "
3864|NCT03516292|"~     The objective of this study is to investigate the role of certain biomarkers in the initial~     assessment of women with overactive bladder (OAB). Nerve Growth Factor (NGF) levels, measured~     in urine samples, and bladder wall thickness (BWT), determined by two-dimensional~     transvaginal ultrasound, are two of those markers. The investigators hypothesize that the~     pre-operative determination of these biomarkers in women suffering from genital prolapse and~     overactive bladder could lead to a more accurate prognosis of the post-operative course of~     overactive bladder symptoms in women undergoing surgical treatment of prolapse.~   "
3865|NCT03516279|"~     This phase II trial studies how well pembrolizumab and dasatinib, imatinib mesylate, or~     nilotinib work in treating patients with chronic myeloid leukemia and persistent detection of~     minimal residual disease, defined as the levels of a gene product called bcr-abl in the~     blood. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of cancer~     cells to grow and spread. Dasatinib, imatinib mesylate, and nilotinib may stop the growth of~     cancer cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and~     dasatinib, imatinib mesylate, or nilotinib may work better in treating patients with chronic~     myeloid leukemia.~   "
3866|NCT03516266|"~     This study aims to investigate the status of pelvic floor function of healthy female in~     China, including premenopausal nullipara, premenopausal women with childbirth and~     postmenopausal women.~   "
3867|NCT03516253|"~     Recent literature data suggest beneficial effects of dietary fats in patients with cancers,~     in particular polyunsaturated fatty acids (PUFAs). Fish oil and evening primrose oil provide~     a high amount of PUFAs and a desirable n-6/n-3 PUFAs ratio.~   "
3918|NCT03515590|"~     The purpose of this study is to compare the changes in blood lipids and feelings of satiety~     after consumption of oil-in-water emulsions in which the droplets are in either the liquid or~     solid (i.e. crystalline) states.~   "
3868|NCT03516240|"~     Delayed onset muscle soreness (DOMS) can be identified as the muscular pain that occurs due~     to intense use of skeletal muscle through exercise or other activities performed intense~     enough or long enough to cause minor damage(Cheung et al., 2003). DOMS usually begins to show~     symptoms 24 hours post-activity, becomes most intense 48-72 hours post-activity and can~     sometimes last up to 5-10 days in ordinary cases(Cheung et al., 2003; Dutto and Braun 2004).~     Typical less severe cases still can cause an individual to alter proper movement mechanics -~     this alteration in mechanics can lead to the further injuring of the involved or compensating~     skeletal muscle tissues and the associated joints and skeletal structures. DOMS-related~     muscular pain can lead to functional deficits and altered movement mechanics that can lead to~     a greater risk of further injury or sources of pain. The body does this by trying to avoid~     the initial source of pain by adopting some form of compensation (such as a limp when~     walking) which may help reduce pain at the initial source but lead to another source of pain~     or risk injury at another joint or limb. DOMS is a common complaint of many runners from~     novice to expert and due to the increased forces in running, a compensatory pattern in~     walking is exaggerated in running and can affect the compensating structures to an even~     greater extent, further increasing the risk of injury. Biofreeze®, a topical analgesic, is~     used to block the pain signal from the affected structures to the brain when applied to~     muscles experiencing delayed onset muscle soreness. Blocking the pain signal from DOMS should~     allow an individual to restore their natural movement mechanics.~      The purpose of this study is to assess the interaction between Biofreeze® and delayed onset~     muscle soreness and how it affects movement mechanics and muscle function.~      Hypothesis: The application of a topical analgesic (Biofreeze®) on muscles experiencing~     delayed onset muscle soreness (DOMS) will increase force production and return running~     biomechanics to pre-DOMS values.~   "
3869|NCT03516227|"~     The major aim of this study is to investigate the effects of biofeedback assisted abdominal~     breathing training on improving the psychological and physiological distress in patients with~     ACI. In this randomized, controlled, single-blind trial, AIS patients were randomly assigned~     into experimental and control groups. The experimental group received four HRVBF training~     sessions. The control group received routine care. Repeated measures of HRV, Mini-Mental~     Status Examination (MMSE), Hospital Anxiety and Depression Scales (HADS), and Barthel Index~     for ADLs were collected prior to, and at one, and three months post-intervention.~   "
3870|NCT03516214|"~     The aim of this trial is to identify the maximum tolerated dose (MTD)/recommended phase II~     dose (RP2D) for a continuous treatment with EGF816 and trametinib in patients with epithelial~     growth factor receptor (EGFR) p.T790M-positive resistance to EGFR inhibition.~   "
3871|NCT03516201|"~     As few is known about the oral health of bariatric patients, this study aimed to analyze the~     prevalence and severity of erosive tooth wear, dental caries and periodontal diseases of~     obese patients who underwent bariatric surgery in comparison to obese patients without~     bariatric procedures.~   "
3872|NCT03516188|"~     A randomized, open-label study with antacid-control will be performed over 48 hours period by~     continuous pH impedance and bravo capsule monitoring. Asymptomatic obese patients will be~     separated into either groups according to alginate antacid group [Gaviscon Advance (GA)®,~     Reckitt Benckiser, UK] and non antacid alginate group [simple antacid]. Both groups will be~     studied for 48 hours using the ambulatory wireless capsule and pH impedance. Participants~     according to their group will take either alginate antcid [Gaviscon Advance (GA)®, Reckitt~     Benckiser, UK] or non alginate antacid [simple antacid] which has equivalent strength of~     antacid after taking late night standardised meals.~   "
3873|NCT03516175|"~     It has been demonstrated that Transnasal Humidified Rapid Insufflation Ventilatory Exchange~     used during preoxygenation for emergency surgery is at least equally effective as~     preoxygenation compared to standard tight fitting mask. Data from a recent study indicates~     that Transnasal Humidified Rapid Insufflation Ventilatory Exchange might decrease the risk of~     clinically relevant desaturation below 93% of arterial oxygen saturation. The limitations~     with our previous study is that it was done only during office hours (Mon-Friday 8 am to 4~     pm) and that the power to detect the occurrence of desaturation was too low.~      Based on the above, the aim is now to conduct a clinical international multicenter study 24/7~     with 450 patients and with a simplified protocol that allows the study to be done 24/7. This~     study is done with the aim of evaluation before implementing this novel technique of~     preoxygenation into clinical practice.~      The general purpose of this project is to compare a the preoxygenation technique based on~     Transnasal Humidified Rapid Insufflation Ventilatory Exchange with traditional preoxygenation~     with a tight fitting mask during rapid sequence induction (RSI) intubation in patients~     undergoing emergency surgery.~   "
3874|NCT03516162|"~     This study will thus examine daily behaviour based on smartphone use and link it to the~     neurological and neuropsychological status as well as to neuroradiological studies that are~     part of the clinical routine. The study will examine behaviour changes before and after~     surgery, and how this change in measured behaviour with the smartphone relates to today's~     gold standard, namely professional neuropsychological examination and quantification of~     brain damage on imaging studies (MRI).~      This study is a proof-of-principle study that intends to build the basis for larger future~     observational studies on patients with focal or diffuse brain pathologies.~   "
3875|NCT03516149|"~     The purpose of this study is to investigate the acute effects of foam rolling on elbow joint~     sensorimotor function with healthy participants . Study group will receive foam rolling~     exercise. Control group will receive no foam rolling exercise. Control group will be given a~     brochure including information about proprioception and foam rolling.~   "
3876|NCT03516136|"~     A Single arm, single site, retrospective cohort Post Marketing Clinical Follow up Study~     Evaluating the Safety and Performance of the EndoFast Reliant SCP for apical support.~   "
3877|NCT03516123|"~     This is a multicenter, open label, dose escalation & expansion phase I study to evaluate the~     clinical safety, tolerability, PK, and preliminary efficacy of CS3006.~   "
3878|NCT03516110|"~     The objective of the study is to compare the evolution over 6 months of Health-Related~     Quality of Life (HRQOL) among different age groups in subjects with prostate cancer treated~     with GnRH agonist therapy.~   "
3879|NCT03516097|"~     Transdisciplinary practice-based action research project that aims to develop innovative~     cognitive-behavioral interventions to empower adolescents, through increased and interactive~     contact between adolescent and multidisciplinary healthcare team. Project born from the~     discussion with trans-territorial stakeholders (health professionals and school communities),~     in the absence of an integrated, creative and dynamic strategy of overweight prevention and~     promotion of salutogenic behaviors in adolescents.~      The polytechnics of Leiria, Santarém and Castelo Branco are co-promotors of this project, as~     well as Município de Leiria (City Council), key partners in the development and~     implementation of the intervention program. It is expected the partnership with ARS-Centro.~      The main goal is the development, implementation and evaluation of a program for the~     promotion of healthy behaviors and prevention of obesity in adolescence, based on e-therapy~     and sustained by the case management methodology.~   "
3882|NCT03516058|"~     The purpose of this study was to investigate the effect of simulation based practice on~     anesthesiology trainee in ultrasound-guided transversus abdominis plane(TAP) block using an~     anesthetized porcine model.~      The residents filled out a questionnaire before and after the training session. The~     questionnaires consisted of knowledge including ultrasound anatomy and block technique,~     comfort, confidence, and axiety levels for the TAP block.~   "
3883|NCT03516045|"~     The aim of this study is to investigate the clinical value of [18F]aluminum~     fluoride-1,4,7-triazacyclononane-1,4,7-triacetic~     acid-neurotensin（18F-AlF-NOTA-neurotensin）positron emission tomography / computed tomography~     (PET/CT) in patients with prostate cancer (PCa).~   "
3884|NCT03516032|"~     In inpatient older adults, decrement in their mobility and loss in their physical activity~     are seen in time line between their hospitalization and discharge. The aim of our study was~     to investigate the effect of physiotherapy and rehabilitation program on physical activity,~     functional skills and quality of life in elderly inpatient. A total of 124 patients who were~     randomized as study and control group followed by Hacettepe University Faculty of Medicine~     Department of Internal Medicine, Division of Geriatric Medicine were included to the study.~     Thirty minutes physiotherapy and rehabilitation program was applied to the patients in the~     study group according to their functional levels. Geriatric patients in the control group did~     exercises by themselves. Demographic data, cognitive functions, muscle strength, presence of~     comorbidity, functional mobility, physical activity, daily living activities, fear of fall,~     quality of life and depression status were assessed of all cases. Activities of daily living~     and depression status was questioned again three months later. This study evaluated the~     efficacy and cost effectiveness of increasing physical activity in older people during~     inpatient rehabilitation. These results could assist in the development of evidenced-based~     rehabilitation programs for this population.~   "
3885|NCT03516019|"~     In this research the investigators will develop and test an innovative scalable mobile health~     and digital cardiovascular monitoring system within a longitudinal deeply characterized~     cohort with three components: 1) smartphone application (app) designed to promote adherence,~     integrate digital and mHealth information, and facilitate communication with participants and~     researchers; 2) smartwatch activity monitoring using the Apple iWatch; and 3) home blood~     pressure (BP) monitoring using the Withings blood pressure device.~      The objective of the messaging trial is to test the effect of messaging strategies on~     improving participants' long-term use of and engagement with our selected mobile health~     technologies and on increasing response rate of survey data collection.~   "
3886|NCT03516006|"~     Primary sclerosing cholangitis (PSC) is an idiopathic condition with intrahepatic cholangitis~     and fibrosis, leading to multifocal bile duct stricture. Its main clinical manifestations are~     chronic cholestatic lesions and is deemed as autoimmune liver disease. PSC are immune~     abnormalities that occurs in patients with genetic susceptibility. No other pathogenesis is~     revealed yet. Ursodeoxycholic acid is used as an empirical treatment, and there is no~     approved drug or a acceptable treatment regimen. The disease often progresses to liver~     decompensation and requires liver transplantation. In recent years, the clinical application~     of stem cell therapy has seen many important advances. Stem cells are characterized with~     properties of multiple differentiation, repair of damaged tissue and immuno-modulation. This~     study aims to employ UCMSCs to treat PSC patients and observe its efficacy and safety, and to~     explore the possible therapeutic mechanisms.~   "
3887|NCT03515993|"~     A cross-sectional prospective study of follow-up in gynecologic cancer patients after primary~     treatment~   "
3888|NCT03515980|"~     This is an investigational study of experimental Medication BMS-986231 given to participants~     with weakened or damaged liver function.~   "
3889|NCT03515967|"~     Study will test the use of a short virtual reality driven goggle test as a means of detecting~     mTBI in a diverse group of athletes~   "
3890|NCT03515954|"~     A retrospective study was performed on 8 eyes of 8 patients who underwent amniotic membrane~     graft after diffuse conjunctival squamous cell neoplasia excision followed by topical~     mitomycin C 0.04% eye drop between March 2014 and January 2018.~   "
3891|NCT03515941|"~     This is an open-label, stratified, two arm design. All patients receive same initial standard~     preoperative chemotherapy and surgical resection. Patients will then be assigned to either~     standard postoperative chemotherapy if node negative at surgery or standard postoperative~     chemoradiation if node positive at surgery.~      The primary objective of this study is to determine the feasibility of patients enrolling and~     receiving either postoperative chemoradiation or chemotherapy alone, based upon nodal status~     at surgery, following preoperative chemotherapy.~      The secondary Objectives is to evaluate the rate of cancer recurrence in patients assigned to~     treatment based upon node status. To explore the potential correlation between changes in~     expression of a pre-specified panel of genes identified as relevant to gastrointestinal~     cancers in response to preoperative chemotherapy, using presence of nodal involvement at time~     of surgery as an indicator of response.~   "
3892|NCT03515928|"~     The aim of this research is to investigate the effects of ultrasonic noise exposure on the~     human auditory system (how it effects hearing). Current international regulations concerning~     ultrasound exposure differs significantly and are based on scarce and outdated scientific~     data; hence the motivation for this research. A cohort of 20 audiometrically healthy~     volunteers will undergo pure tone audiometry (PTA); a standard test for hearing sensitivity,~     at both pre and post exposure to ultrasonic noise (40kHz for 15 min at 120 dB SPL). A~     subgroup of 10 subjects will be used as a control group. The resulting audiograms will~     establish the extent of any recoverable loss in hearing sensitivity known as temporary~     threshold shifts (TTS).~   "
3893|NCT03515915|"~     Panobinostat is a potent oral histone deacetylase inhibitor that alters gene expression~     through epigenetic mechanisms and inhibits protein degradation. It was recently approved by~     the US Food and Drug Administration for use in combination with bortezomib and dexamethasone~     in patients with relapsed multiple myeloma (MM) who have received ≥ 2 prior regimens,~     including bortezomib and an immunomodulatory drug.~      A GEP-based histone acetylation score allowing identification of MM patients with a poor~     prognosis and who could benefit from HDACi treatment was recently reported(Moreaux et al.~     BJC. 2013).~      Our hypothesis is that the histone acetylation score could be promising to identify MM~     patients who could benefit from treatment with HDACi and the development of personalized~     treatment.~   "
3894|NCT03515902|"~     Tooth hypersensitivity due to dental erosion is one of the most common problem related to~     swimming in improper pH chlorinated pools. Because the teeth are exposed to acidic water for~     a long time, which cause the loss of dental hard tissue. Tooth hypersensitivity can lead to a~     negative effect on daily life such as dietary selection, maintaining optimal dental hygiene~     and beauty aspects. It has been found that using mouthguard while swimming can prevent the~     teeth directly contact to chlorinated water, so it can protect tooth structure and decrease~     tooth hypersensitivity. Moreover, using mouthguard with viscous products can seal the gaps~     between mouthguard and teeth which can help to protect tooth structure and decrease dental~     hypersensitivity more effectively. At present, there are many desensitizing products such as~     toothpaste, mouthwash and chewing gum. Desensitizing toothpaste is the most common~     over-the-counter (OTC) materials in desensitizing. Many research has endorsed the properties~     of desensitizing toothpaste that can reduce tooth tissue loss and helps to reduce tooth~     hypersensitivity effectively. So it can be hypothesize that when use the combination of~     mouthguard with desensitizing toothpaste, it might have synergistic effect on reducing tooth~     hypersensitivity in swimmers.~   "
3895|NCT03515889|"~     This study will examine whether, compared to a standard, low-fat, calorie-restricted diet~     intervention, the clinic-supported Ideal Protein weight loss method will result in greater~     weight loss and improvement in cardiometabolic risk factors over 3 months among obese adults~     with cardiovascular disease (CVD) risk factors.~   "
3896|NCT03515876|"~     To compare the EEG power spectra activity during propofol-based anesthesia in the presence or~     absence of dexmedetomidine in patients undergoing hysteroscopic examination and surgery to~     determine whether the addition of dexmedetomidine will induce better sleep-like anesthesia~     status.~   "
3897|NCT03515863|"~     The aim of this study is to complete the identification of genetic factors predisposing to~     thyroid associated ophthalmopathy (TAO) by constituting a cohort of 400 Grave's patients with~     or without ocular signs.~   "
3898|NCT03515850|"~     The vascular branches of inferior mesenteric artery (IMA) involve superior rectal~     artery(SRA),Sigmoid artery(SA) and the left colic artery(LCA). Different levels of ligation~     of the (IMA) are applied in rectal cancer surgery, including retain or not retain the left~     colic artery(LCA). Retained the LCA would facilitate the vascularity. The variations of~     vessels are more frequent in the combinations of branches, while LCA, SA and SRA may vary~     from people to people. Which contribute to the difficulty of surgery to retain the LCA.. As a~     result, a better understanding of the anatomical branches classification of IMA is a must~     during operation. However, existing studies of IMA's branches combination are very rare and~     often single-centered with minimal samples. In order to achieve better surgical outcome and~     reduce operative complications, the investigators design this study to investigate the~     anatomical classification of IMA and the surgical outcome of each type~   "
3899|NCT03515837|"~     The purpose of this study is to evaluate the efficacy and safety of pemetrexed plus platinum~     chemotherapy (carboplatin or cisplatin) with or without pembrolizumab (MK-3475; KEYTRUDA®) in~     the treatment of adults with the following types of tyrosine kinase inhibitor~     (TKI)-resistant, epidermal growth factor receptor (EGFR)-mutated, metastatic non-squamous~     non-small cell lung cancer (NSCLC) tumors: 1) TKI-failures (including osimertinib [TAGRISSO®]~     failure) with T790M-negative mutation tumors, 2) T790M-positive mutation tumors with prior~     exposure to osimertinib, and 3) first-line osimertinib failure regardless of T790M mutation~     status.~      The primary study hypotheses are that the combination of pembrolizumab plus chemotherapy has~     superior efficacy compared to saline placebo plus chemotherapy in terms of: 1)~     Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1~     (RECIST 1.1) based on blinded independent central review, and 2) Overall Survival (OS). This~     study will be considered to have met its success criteria if the combination of pembrolizumab~     plus chemotherapy is superior to saline placebo plus chemotherapy in terms of PFS or OS.~   "
3900|NCT03515824|"~     The purpose of this study is to evaluate the safety and preliminary efficacy of MK-1697.~     There are 2 parts in this study: dose escalation to determine the recommended phase 2 dose~     (RP2D) and confirm the RP2D (Part A) and cohort expansion to determine preliminary efficacy~     in participants with adenocarcinoma of the stomach and/or gastroesophageal junction (GEJ) or~     head and neck squamous cell cancer (HNSCC) (Part B).~   "
3901|NCT03515811|"~     The objectives of this prospective, two-arm, multicenter post-market study is to confirm~     safety and performance through the incidence of subjects reporting serious adverse device~     effects (ADEs) up to and including 30 days following use of Signia™ Stapling System with Endo~     GIA™ with Tri-Staple™ Technology and Tri-Staple™ 2.0 Intelligent Reloads in subjects~     undergoing indicated abdominal or thoracic procedures for resection, transection and creation~     of anastomosis per the IFU.~   "
3902|NCT03515798|"~     This phase II multicentre randomized open-label study will assess the safety and efficacy of~     Pembrolizumab in combination with standard chemotherapy in inflammatory breast cancer.~     Pembrolizumab will be administered every 3 weeks during the neoadjuvant chemotherapy. Tissue~     and blood samples will be collected pre- and post-treatment for translational research.~   "
3903|NCT03515785|"~     The purpose of this study is to evaluate the effectiveness and safety of ponatinib (Iclusig®)~     in patients with BCR-ABL positive acute lymphoblastic leukemia (ALL) in standard clinical~     practice in Europe.~   "
3904|NCT03515772|"~     Ageing is characterized by physiological changes, which can impact drug pharmacokinetics and~     thereby cause drug-drug interactions. This study aims to assess the pharmacokinetics of~     amlodipine, atorvastatin and rosuvastatin in the presence of darunavir/ritonavir (inhibitor~     of drug metabolizing enzymes and drug transporters), by comparison with dolutegravir (no~     inhibitory effects on cytochromes or transporters involved in the disposition of the~     evaluated co-medications), in order to characterize the importance of drug-drug interactions~     in elderly individuals.~   "
3919|NCT03515577|"~     This phase II trial compares how well gallium 68-labeled PSMA-11 positron emission~     tomography/computed tomography (PET/CT) works compared to fluciclovine F18 PET/CT in imaging~     participants with prostate cancer after surgery that has come back. PET is an established~     imaging technique that uses small amounts of radioactivity and CT images provide an exact~     outline of organs and potential inflammatory tissue where it occurs in the body. Diagnostic~     procedures, such as PET/CT with gallium 68-labeled PSMA-11, may work better than PET/CT with~     fluciclovine F18 in helping find out how far the prostate cancer has spread.~   "
3905|NCT03515759|"~     60 pregnant women with singleton living fetus between 34 -38 wks gestation known to have~     severe hypertension in the current pregnancy were included.~      All participants underwent Doppler ultrasonography to evaluate the Feto-Placental Circulation~     within 24 hours from Pregnancy Termination.~      Flow Velocity Waveforms were obtained from: Umbilical Artery (UA), Middle Cerebral Artery~     (MCA), Ductus Venosus (DV), Umbilical Vein (UV).~      From the flow velocity waveforms the following indices were measured:~      UA & MCA: Pulsatility Index (PI) & Resistance Index (RI), DV: Peak Velocity Index For veins~     (PVIV), Peak Systolic Velocity (PSV) & a- wave.~      UV Flow: Presence or Absence of Pulsatile Flow.~   "
3906|NCT03515746|"~     A pilot study with the 10cubes for small and precise movements and training in the virtual~     environment will be carried out. We will recruit at least 20 persons with Parkinson's disease~     to participate in the study. Such activities can increase participation, slow down the~     progress of the disease and contribute to the functional improvements of the hand that lead~     to the increased quality of life. The movement of the hand will be assessed with a small 3D~     camera, also suitable for the estimation of kinematic parameters. Participants will be~     randomized into 2 groups; one group using an LCD screen and the other using 3D goggles~     (Oculus Rift CV1) enabling them to carry out the task in virtual environment. Both groups~     will take 10 training sessions within 2 weeks. Their task will be collecting 10 virtual cubes~     one-by-one and putting them in the virtual treasure box. Clinical tests (Box and Blocks Test~     and motor part of the UPDRS) will be carried out in the clinical settings prior and after the~     training sessions. We hypothesise that the different feedback equipment may provide different~     results.~   "
3907|NCT03515733|"~     This study will test whether seven days adjunctive administration of a serotonin receptor~     subtype 4 (5HT4) agonist called PF-04995274 has positive effects on emotional processing and~     neural activity in medicated, treatment-resistant depressed patients compared to placebo.~   "
3908|NCT03515720|"~     Patellar chondromalacia is the degeneration of articular cartilage located on the posterior~     face of the patella and may suggest the onset of an osteoarthrosis. It predominates in~     sedentary people who overload the joint, as well as people with insufficiency in the extensor~     muscles of the knee. It is often seen between 30 and 40 years. Conservative management is the~     main treatment option and surgical intervention is considered as a last option in a small~     number of patients. A new treatment option is neuroprolotherapy where the approach is~     directed at the subcutaneous nerves as the source of pathology, which can lead to neurogenic~     inflammation and pain.~   "
3909|NCT03515707|"~     This phase II trial studies how well autologous stem cell transplant works in treating~     patients with favorable or intermediate risk, minimal residual disease (MRD)-negative, acute~     myeloid leukemia. Giving chemotherapy before a peripheral blood stem cell transplant helps~     kill any cancer cells that are in the body. After treatment, stem cells are collected from~     the patient's blood and stored. Higher dose chemotherapy is then given to prepare the bone~     marrow for the stem cell transplant. The stem cells are then returned to the patient to~     replace the blood-forming cells that were destroyed by the chemotherapy.~   "
3910|NCT03515694|"~     Time of appearance of TOF Ratio >0,9 with different doses of Sugammadex~   "
3911|NCT03515681|"~     The investigators propose to conduct pilot studies to support an application to conduct a~     fully powered randomized trial of a text messaging intervention to increase the rate of blood~     pressure control, defined as <140/90 mmHg, among hypertensive individuals using health kiosk~     blood pressure devices. These pilot studies will include testing of the intervention,~     recruitment, enrollment, and data collection procedures, and of the web-based interactions~     between the data coordinating center and higi Sh llc (Chicago, IL), which is the company that~     installs and maintains the health care kiosks and associated software infrastructure.~     Completion of these pilot studies will provide preliminary data to support an application for~     a full scale randomized controlled study. Potential for adaption is high because of alignment~     of retail outlets, kiosk providers, and consumers for health, wellness, and self-care.~   "
3912|NCT03515668|"~     our goal is to study the effects of dopamine activity, using Ritalin ingestion, on~     neuromuscular function over the course of a progressive heating and cooling protocol~     developed in our lab. We hypothesize that Ritalin will minimize the previously reported~     progressive impairment in neuromuscular function with hyperthermia compared to placebo,~     suggesting that dopamine activity preserves neuromuscular capacity with hyperthermia.~   "
3913|NCT03515655|"~     A study of participants hospitalized with acute heart failure with reduced ejection fraction~   "
3914|NCT03515642|"~     This project offers the opportunity to obtain detailed measurements on the health of body~     composition, metabolic health, and intestinal microbial diversity in overweight adults;~     moreover to provide information about the effects of physical exercise on them. The aim of~     the research is to advance in the understanding of the mechanisms induced by physical~     exercise, which includes the measurement of nutritional parameters, clinical and biochemical~     biomarkers of hepatic/cardiometabolic health, as well as the application of differential~     proteomics technologies by means of Arrays of cytokines and intestinal microbiome, making~     this study a novel and pioneer in sensitive areas of primary health care in Latin America.~   "
3915|NCT03515629|"~     The primary objective of the study is to compare the progression-free survival (PFS) of~     REGN2810 (cemiplimab) plus ipilimumab combination therapy (hereinafter referred to as~     REGN2810/ipi) and REGN2810 plus 2 cycles only of platinum-based doublet chemotherapy plus~     ipilimumab combination therapy (hereinafter referred to as REGN2810/chemo/ipi) with~     standard-of-care pembrolizumab monotherapy in the first-line treatment of patients with~     advanced squamous or non-squamous non-small cell lung cancer (NSCLC) whose tumors express~     programmed death ligand 1 (PD-L1) in ≥50% of tumor cells. The key secondary objectives of the~     study are to compare the overall survival (OS) of REGN2810/ipi and REGN2810/chemo/ipi with~     pembrolizumab monotherapy in the first-line treatment of patients with advanced squamous or~     non-squamous NSCLC whose tumors express PD-L1 in ≥50% of tumor cells and to compare the~     overall response rate (ORR) of REGN2810/ipi and REGN2810/chemo/ipi with pembrolizumab~     monotherapy in the first-line treatment of patients with advanced squamous or non-squamous~     NSCLC whose tumors express PD-L1 in ≥50% of tumor cells.~   "
3916|NCT03515616|"~     - Ultrasound during first stage of labour has a very important role in prediction of mode of~     delivery~   "
3917|NCT03515603|"~     Prospective and randomized compare between microsurgical and endoscopic transsphenoidal MRI~     assisted resection of pituitary adenomas.~   "
3920|NCT03515564|"~     Conflict in Syria and Iraq has created a humanitarian crisis that includes hundreds of~     thousands of refugees who have experienced trauma and suffer from a greater incidence of~     trauma-related disorders as compared to the general population. The need for intervention is~     clear: our research team has determined prevalence of probable PTSD, anxiety, and depression~     in adults at rates of 32.2%, 40.3% and 47.7%, respectively and children at rates of 6.3% for~     PTSD and 52.9% for anxiety. Barriers to treatment include cultural ideations surrounding~     psychiatric treatment, language barriers posed to psychotherapy, and high dropout associated~     exposure therapy—the standard treatment for PTSD. To overcome these challenges, the~     investigators developed a behavioral health program that addresses not only the psychological~     but also the somatic components of trauma-related disorders which are common but often less~     addressed by traditional treatment. This 12-week family-based program offers weekly, 90~     minute sessions in Dance/Movement Therapy (DMT) or Art Therapy for children, mindful yoga for~     mothers, and High Intensity Interval Training (HIIT) for fathers as well as complimentary~     transportation to and from sessions. Self-report questionnaires and biological specimens~     (hair cortisol; saliva or blood inflammation markers) are collected at the beginning, middle,~     and end of the intervention phase, as well as 3, 6, and 12 months afterwards to measure acute~     and long-term effects of these treatments. By collecting psychological and biomarker data the~     investigators seek concrete scientific evidence supporting these non-pharmacological, cost~     effective, and accessible programs as reliable treatment options.~   "
3921|NCT03515551|"~     IMCnyeso is a new biological therapy designed for the treatment of cancers which express~     NY-ESO-1 and/or LAGE-1A. This is a first-in-human trial designed to evaluate the safety and~     efficacy of IMCnyeso in adult patients who have the appropriate HLA-A2 tissue marker and~     whose cancer is positive for NY-ESO-1 and/or LAGE-A1.~   "
3922|NCT03515538|"~     The purpose of this study is to determine if RRx-001, which is added on to the cisplatin and~     radiation treatment, reduces the duration or length of severe oral mucositis in patients with~     head and neck cancers. All patients in this study will receive 7 weeks of standard of care~     radiation therapy given with the chemotherapy agent, cisplatin. Patients in arms 1, 2 and 3~     will also receive RRx-001 on different schedules.~   "
3923|NCT03515525|"~     A retrospective review of patients who developed hematoma following breast surgery from 2003~     to 2018 in a single institution was performed. The study investigated the value of~     closed-suction drains regarding the quantity and quality of fluid secretion for the~     prediction of subcutaneous hematoma in patients undergoing breast surgery procedures.~   "
3924|NCT03515512|"~     This research study is studying a targeted therapy drug as a possible treatment for IDH2~     mutant acute myeloid leukemia or chronic myelomonocytic leukemia while undergoing~     hematopoietic stem cell transplantation.~      The drug involved in this study is:~      -Enasidenib.~   "
3925|NCT03515499|"~     Financial incentives have been suggested as a possible means for increasing adherence to~     asthma medications. This study will evaluate an incentive strategy (daily small reward for~     adherence) in maintaining high levels of adherence as tracked by adherence sensors in~     adolescents with asthma.~   "
3926|NCT03515486|"~     Post-stroke mood disorders (PSMD), including depression, anxiety and apathy, are observed in~     about 30 % of stroke patients at follow-up 3 or 4 months after stroke occurrence. They impair~     the functional outcome of the patients and their quality of life. Among the different brain~     structures involved in PSMD the role of the cerebellum has been under-evaluated while it is~     now well-known to be involved in mood regulation. The aim of this study will be to describe~     the characteristics of mood disorders following a first acute ischemic cerebellar stroke~     using face to face interviews and mobile technologies and investigate their~     pathophysiological mechanisms through advanced brain Magnetic resonance imaging (MRI)~     evaluation of cortico-cerebello-cortical morphological and functional connectivity.~   "
3927|NCT03515473|"~     Background The authors' aim was to compare the influence of various electrode designs on~     selected objective and subjective clinical outcomes for cochlear implant recipients using the~     same model of receiver-stimulator, Cochlear™ Nucleus® Profile Series and sound processor.~      Methods A multicenter study with subjects with profound sensorineural hearing loss, who were~     implanted and followed up in two tertiary centers. A total of 54 ears were implanted with~     Cochlear™ Nucleus® CI532, 51 with Cochlear™ Nucleus® CI522 and 54 with the Cochlear™ Nucleus®~     CI512. Implant loss and intraoperative electrophysiological tests (electrically evoked~     stapedial reflex threshold [ESRT], neural response telemetry threshold [T-NRT] and~     impedance), postoperative data (C-level, T-level, dynamic range, T-NRT and power consumption)~     and intracochlear position of the active electrode were analyzed with Nucleus Custom Sound~     4.4 software.~   "
3928|NCT03515460|"~     The present study was designed to evaluate vascular endothelial dysfunction resulting from~     the oral ingestion of high loads of sugar and fat meals in healthy individuals.~   "
3929|NCT03515447|"~     The investigators developed a platelet transfusion saving strategy based on thrombopoietin~     administration in heart or lung transplantation (HLT) patients or assist device implantation~     in bridge-to-transplantation (BTT) or bridge to-decision (BTD). This strategy was applied~     from May 2014 to October 2015 in patients whose platelet counts were below 100 Giga per liter~     (G/L). As part of a health care quality improvement project, the investigators evaluated this~     strategy in a before/after design. January 2010 to December 2013 constituted the before~     period.~   "
3930|NCT03515434|"~     Multimodal analgesia is used to control postoperative pain in inguinal hernia repair.~     Transversus abdominis plane block is an effective regional anesthesia technique for~     postoperative analgesia in inguinal hernia repairs. The erector spinae plane block applied to~     thelow thoracic region was also reported to provide effective analgesia in these surgeries.~     In this study, we aimed to determine and compare the effects of transversus abdominis plane~     block and lumbar erector spinae plane block on postoperative pain in inguinal hernia repairs.~   "
3931|NCT03515421|"~     Clinical Evaluation of Blood Glucose Monitoring Systems (BGMSs)~   "
3943|NCT03515265|"~     Clinical performance of direct fiber reinforced resin composite restorations versus direct~     microhybrid resin composite restorations in endodontically treated molars will be evaluated~     over 6 months using modified USPHS criteria.~   "
8575|NCT03454620|"~     The purpose of the study is to assess the safety and tolerability of GC1118 in combination~     with irinotecan or FOLFIRI in order to determine the maximum tolerated dose (MTD) and the~     recommended phase 2 dose (RP2D)~   "
3932|NCT03515408|"~     Attention deficit hyperactivity disorder (ADHD) patients have some problem with sustained~     attention. The dorsal anterior cingulate cortex (dACC) plays a key role for attention~     control. It has been found that the dACC has strong functional connectivity with ipsilateral~     motor area and parietal gyrus. Repetitive Transcranial Magnetic Stimulation (rTMS) is a sage~     and painless technique to activate cortical areas. The deep brain structure can be activated~     via stimulating superficial cortex by rTMS. For investigating the mechanism of sustained~     attention, this project is using functional magnetic resonance imaging (fMRI) to~     individualize the precise localization in motor area and parietal gyrus, and combining rTMS~     to activate the dACC.~   "
3933|NCT03515395|"~     Older persons are at riskt for falls and fractures. After hip surgery they are normally~     treated with physical or occupational therapy. The additional use of computer based exercise~     games for training and the acceptance of such a technology are unclear. Thus, we plant to~     assess the above outcome ins an observational pilot study.~   "
3934|NCT03515382|"~     The sponsor wants to investigate how well the test medicine is taken up by the body when~     given alongside two other already approved medicines. This kind of study is known as a~     drug-drug interaction study. In this case the other medicines are itraconazole and~     voriconazole.~      The sponsor will also look at the safety and tolerability of the test medicine when taken~     alone, and when taken with the approved medicines.~   "
3935|NCT03515369|"~     The aim of this study is to evaluate the effect of traditional Chinese medicine Babaodan on~     tumor recurrence of hepatocellular carcinoma after curative resection, as well as the safety~     of this treatment~   "
3936|NCT03515356|"~     This randomized, controlled, pilot experiment will evaluate the effects of an aerobic walking~     intervention on OIPN (oxaliplatin-induced peripheral neuropathy) in patients with colorectal~     cancer who are already prescribed FOLFOX by their oncologists. FOLFOX is a standard~     oxaliplatin-based chemotherapy treatment for stage II-III colorectal cancer that causes~     oxaliplatin-induced peripheral neuropathy (OIPN) in 85-95% of patients.~   "
3937|NCT03515343|"~     This prospective randomized clinical trial aims to evaluate the new Optivista system compared~     to the iScan for his optical diagnosis and interval agreement monitoring with pathology. The~     Participants will be randomized to be diagnosed by either Optivista or Pentax iScan, and all~     polyps detected during the procedure, their size, location and morphology will be recorded~     according to the Paris classification after which all polyps will be resected per standard~     practices and sent for histopathologic evaluation. Further optical assessments will be~     performed for all polyps of 1-10 mm in size (WASP, NICE, SANO and SIMPLE classification)~     after with an analysis of comparison between optical diagnosis and pathology results will be~     performed.~   "
3938|NCT03515330|"~     The investigators are interested in whether or not the use of a mobile health (mHealth)~     application increases the rate of immunosuppressant medication adherence among adult liver~     transplant recipients. The investigators aim to test this by randomly assigning transplant~     recipients to the intervention (use of an mHealth app to manage and track their~     immunosuppression regimen) or control arm (standard of care) upon discharge from their~     initial transplant hospitalization, and tracking medication adherence over time. The study~     population will be approximately 50 adult liver transplant recipients at the Johns Hopkins~     Hospital.~   "
3939|NCT03515317|"~     Background: Cognitive impairment is common in patients with traumatic brain injury (TBI) at~     all levels of severity. Such impairments may affect their ability to return to work and thus~     increase healthcare costs and the associated economic burdens. Both cognitive rehabilitation~     and stimulant medications are widely used to manage post-traumatic cognitive impairments;~     however, previous metaanalyses failed to demonstrate their beneficial effects on cognitive~     recovery in patients with TBI. Nurses, the first-line healthcare providers, should therefore~     seek and use an alternative approach for dealing with post-traumatic cognitive deficits.~      Purpose: To assess the effects of low resolution tomography (LoRETA) Z -score neurofeedback~     (NF) and theta/beta NF in alleviating cognitive impairments in patients with TBI as well as~     the possible mechanism through which they provide this alleviation. We hypothesize that~     adults with TBI receiving LoRETA Z-score NF and theta/beta NF will experience the~     improvements in cognitive functions while participants in the control group will not.~   "
3940|NCT03515304|"~     Vascular and myocardial inflammation are significantly increased in Acute Coronary Syndrome~     (ACS) patients, are closely correlated to LDL-C levels, and are associated with these adverse~     consequences in the post-ACS patient population. Serum proprotein convertase subtilisin/kerin~     type 9 (PCSK9) levels are also increased in ACS, may raise LDL-C, and the investigators'~     pre-clinical studies indicate that PCSK9 is also a potent inducer of vascular inflammation.~     The addition of the PCSK9 antibody evolocumab, currently approved to lower LDL-C in certain~     patient populations, to current medical therapies would appear to be of particular benefit in~     an important subset of ACS patients, those with non-ST elevation myocardial infarction~     (NSTEMI) by markedly reducing LDL-C, stabilizing vulnerable plaque, and limiting~     inflammation-associated myocardial cell loss and resultant dysfunction.~   "
3941|NCT03515291|"~     Injury to the heart, which may occur following a heart attack or owing to the mechanical~     effect of high blood pressure, leads to scarring (fibrosis) of the heart muscle. Fibrosis of~     the muscle can cause impaired pumping of the heart, which can lead to heart failure, and the~     abnormal conduction of electrical signals through the heart. This may in turn lead to~     abnormal, potentially fatal, heart rhythms. Currently, scarring of the heart muscle cannot be~     reversed and is generally progressive.~      A previous clinical study found that participants who received injections of immunomodulatory~     progenitor cells (iMP cells, Heartcel) showed a reversal of heart muscle scarring when the~     cells were injected into heart muscle during coronary artery bypass graft (CABG) surgery.~     However, the previous trial was a small scale study and did not have a control group. The aim~     of this study is to perform a larger scale investigation with 50 participants compared to the~     previous trial of 11, and split the 50 participants into two groups - a test group and a~     control group, so that a direct comparison may be made between the two groups.~   "
3942|NCT03515278|"~     The investigators aim to compare the effect of ultrasound-guided suprascapular nerve block~     and intra-articular corticosteroid injection for frozen shoulder in pain control, improvement~     of range of motion, quality of life, and function.~   "
14356|NCT03378999|"~     The primary objective of the study is to examine for the first time the LDL cholesterol~     lowering effect of oven-dried Rhodospirillum rubrum in humans.~   "
3944|NCT03515252|"~     This is a phase I clinical study. Blood is drawn from the patient and brought to our~     laboratory for isolation of immune cells. These immune cells are then proliferated over a two~     week period and used to produce our patented product IKC (Immune Killer Cells). The IKC will~     then infused back into the patient to treat the cancer. Each patient will receive a total of~     six infusions.~   "
3945|NCT03515239|"~     Lumbopelvic fixation is the treatment opation for spinopelvic dissociation. In our study we~     will compare unilateral versus bilateral lumbopelvic fixation as regarding post operative~     pain along a period of 6 monthsas a primary measure and metal failure,skin condition and~     nonunion as secondaries.~   "
3946|NCT03515226|"~     This study will compare training as usual to automated training using an intelligent tutoring~     system in training bachelors (BA) level social workers in cognitive behavioral therapy (CBT).~     The purpose of the study is to determine if time and cost of training front line clinicians~     in evidence-based treatments can be shortened, and if this new training model can reduce the~     need for clinicians to seek advice from experts.~   "
3947|NCT03515213|"~     The purpose of this research study is to study the safety and efficacy of fenofibrate, an~     FDA-approved drug for high cholesterol and/or elevated triglyerides (fats), as a treatment~     for Huntington's disease (HD). Subjects who meet the entry criteria will be randomized (3:1)~     to either 145mg of fenofibrate or placebo.~   "
3948|NCT03515200|"~     Leukemia cells grow and divide fast and out of control. In normal cells, certain proteins~     called CDK4 and CDK6 control cell growth. The study drug called palbociclib works by blocking~     the CDK4 and CDK6 proteins. Palbociclib has been shown to kill leukemia cells in the~     laboratory and in animal studies. Palbociclib will be added to other chemotherapy drugs, such~     as dexamethasone, that are known to be effective in treating childhood ALL.~      This study will be done in two parts: Part 1: Dose Escalation and Part 2: Dose Expansion. The~     goal of Part 1 of the study is to find the highest tolerable combination of palbociclib and~     chemotherapy that the investigators can give to patients with leukemia. Once those doses are~     determined, the investigators will enroll patients on Part 2: Dose Expansion. This phase will~     enroll additional patients that receive the highest tolerated dose of palbociclib as~     determined in part 1, in order to better understand the side effects and how effective this~     treatment approach is.~      With this research study, the investigators hope to meet the following goals:~        -  To find the highest tolerable dose of palbociclib in combination with chemotherapy that~          can be given without causing severe side effects;~        -  To learn what kind of side effects palbociclib in combination with chemotherapy may~          have; and~        -  To learn more about the biology effects of palbociclib on the cells in the participant's~          body.~      Up to 40 children, adolescents and young adults will participate in both parts of this study~     at St. Jude only.~   "
3949|NCT03515187|"~     A multicenter randomized controlled trial on prevention and treatment of ocular surface~     injury and meibomian gland dysfunction in patients using anti-glaucoma eye drops.~   "
3950|NCT03515174|"~     Adolescents and young adults (AYA) patients experience significant distress in specific areas~     at diagnosis. The investigators hypothesize that providing developmentally-appropriate~     AYA-specific psychosocial care, with an individualized multi-disciplinary program will~     alleviate this distress, as well as improve health-related quality of life (HRQOL).~      The investigators' primary aim is to evaluate the impact of psychosocial interventions on~     HRQOL. The secondary aims are to firstly identify the types of psychosocial distress~     experienced and secondly, to assess the feasibility of implementing a psychosocial screening~     and intervention program amongst AYA patients newly diagnosed with cancer.~   "
3951|NCT03515161|"~     The purpose of this study is to evaluate the feasibility, efficay and safety of a novel~     closed-loop (automated) vasopressor administration system that delivers norepinephrine using~     feedback from standard operating room hemodynamic monitor (EV1000 Monitor-Flotrac or~     Clearsight system, Edwards Lifesciences, IRVINE, USA).~   "
3952|NCT03515148|"~     The purpose of this study is to determinate de efectiveness of eccentric exercise combined~     with vibration or cryotherapy in achilles tendinopathy and its effects on the anterior rectus~     abdominis muscle.~      The investigators hypothesis is the combined eccentric exercise with vibration get better~     results than cryotherapy with eccentric exercise in rectus abdominis muscle parameters.~   "
3953|NCT03515135|"~     The goal of this study is to provide a new, early treatment approach for preschoolers with~     ADHD, which could facilitate the EF developing well to achieve better outcome.~   "
3954|NCT03515122|"~     The main aim of this study is to gain an in-depth knowledge of cardiopulmonary and autonomic~     health consequences, and related risk factors among people with long-term high-level spinal~     cord injury. The result of this study will form the basis for further research to improve~     prevention strategies and risk prediction of cardiopulmonary disorders in people with spinal~     cord injury.~   "
3955|NCT03515109|"~     Prospective randomized comparison of minisling (altis) with the TVTO procedure for the~     management of women with genuine stress urinary incontinence.~   "
3956|NCT03515096|"~     The primary objective is to compare the efficacy of eltrombopag vs rhTPO in complete response~     in patients after HSCT in China. This is a post-marketing, interventional, single-center,~     double-arm, prospective, open-label, equivalent, randomized controlled study in adult~     patients with hematopoietic stem cell transplantation in China. Patients will be recruited~     consecutively from the study sites during the enrollment period. The enrolled patients will~     be given eltrombopag or rhTPO under the conditions of informed consent and frequent~     monitoring according to the clinical guideline.~   "
3957|NCT03515083|"~     There is a need to determine actual compliance of direct oral anticoagulants and how to~     improve this to reduce risk of stroke in patients with atrial fibrillation. Mobile health~     tools have been implemented world-wide in various patient populations as means of reducing~     cardiovascular risk and improving disease management. Results of these interventions have~     been mixed with some interventions demonstrating significant improvement while others~     demonstrated no difference between the intervention group and the control group. More~     importantly, these studies indicate that implementation of mobile health tools is feasible in~     various patient populations and it may just be a matter of finding the correct intervention~     for a given disease state. The aim of this study is to increase awareness of atrial~     fibrillation as a means of improving compliance with anticoagulant medication.~   "
3958|NCT03515070|"~     Inflammatory bowel disease(IBD) is a chronic inflammatory condition for gastrointestinal~     tract.~      Regarding its pathogenesis, there has been numerous studies to reveal the complex association~     between genetic and environmental factors.~      In Korea, the incidence of IBD is growing rapidly but genetic studies solely including~     patients with Korean descent were not sufficient enough.~      Therefore, the investigators planned to conduct genetic and fecal microbial analysis for the~     60 individuals from 30 Korean IBD families to find out the pathogenesis of IBD.~   "
3959|NCT03515057|"~     The overall goal of this study is to assess the effectiveness of screening for undiagnosed~     atrial fibrillation (AF) using simple, efficient, and portable electronic health and mobile~     technologies in a healthcare system. The investigators propose to perform population-based~     screening for undiagnosed AF as part of usual care in patients ≥ 65 years when their vital~     signs are checked (spot-check) at scheduled outpatient visits in adult Massachusetts General~     Hospital (MGH) primary care clinics. Patients will receive routine care by their primary care~     provider (PCP) based upon the results of the screening during the visit.~      The investigators hypothesize that rates of AF detection among individuals ≥ 65 years in the~     MGH primary care network will be greater among patients in clinics assigned to the spot-check~     arm compared to patients in clinics assigned to the usual care arm of the study.~   "
3960|NCT03515044|"~     Study to Assess the Efficacy and Safety of Rifaximin Soluble Solid Dispersion (SSD) Tablets~     Plus Lactulose for the Treatment of Overt Hepatic Encephalopathy (OHE).~   "
3961|NCT03515031|"~     The primary objective of this study is to compare the efficacy of treatment with HFNC (group~     A) compared to administration of oxygen therapy by Venturi mask (group B, standard therapy)~     in terms of reaching of endotracheal intubation criteria during acute respiratory failure due~     to severe pneumonia.~      Inclusion Criteria: Respiratory rate (RR) at rest ≥30 bpm or presence of respiratory distress~     (severe dyspnoea at rest or use of accessory respiratory muscles or abdominal paradox); PaO2~     / FiO2 ≤250 during oxygenation with Venturi Oxygenation mask at FiO2 = 50% administered for~     at least 60 minutes; Diagnosis of pneumonia as the sole cause of acute respiratory failure.~     Randomization: 150 consecutive patients will be randomized either to High Flow Nasal Cannula~     Oxygenation (75 patients, HFNCO with flow ≥ 60 L/min and FiO2 to maintain SpO2 ≥ ) or Venturi~     Mask Oxygenation (control, 75 patients).~      Patients from both groups will be treated with antibiotic therapy according to the IDSA/ATS~     2007 guidelines for community-acquired pneumonia and the IDSA/ATS 2016 guidelines for~     hospital-acquired pneumonia.~      Intubation Criteria:~      MAJOR CRITERIA:~      Cardiac or respiratory arrest Breathing pauses with loss of consciousness Severe hemodynamic~     instability Need for sedation~      MINOR CRITERIA (maintained for ≥1h):~      Reduction ≥30% of the value of the PaO2/FiO 2 compared to baseline Increased 20% if PaCO2~     PaCO2 previous ≥40mmHg Worsening alertness as increased by one degree on the Kelly scale~     Persistence or onset of respiratory distress Vital parameters, Kelly scale and arterial blood~     gas analysis (BGA) will be performed on admission, and at 1, 24, at 48 hours, at the~     achievement of clinical stability, and whenever there is a clinical worsening.~      Patients enrolled in HFNC arm will continue HFNC oxygenation until clinical stability,~     defined as:~      Body temperature ≤ 37°C and ≥36°C for 24 consecutive hours Good ability in swallowing CRP and~     WBC normalization trend than the admission exams Hemodynamic stability Lack of respiratory~     distress SpO2 94-98% The primary outcome variable is the proportion of patients who reach the~     endotracheal intubation criteria - regardless of the actual intubation rate - within the~     first 48 hours of treatment. The primary analysis will be performed on the ITT population~   "
3962|NCT03515018|"~     RATIONALE: Drugs used in chronic-phase chronic myelogenous leukemia (CML) aimed to avoid CML~     conversion (AP, BC). Hydroxyurea pulse therapy for chronic-phase CML patients is effective~     based on the investigator's previous studies, and the scheme cost lower than imatinib. It is~     not yet known the efficacy compared Hydroxyurea pulse therapy with imatinib for chronic-phase~     CML, especially to achieve hematological remission in short time.~      PURPOSE: Non-randomized trial to compare the effectiveness of hydroxyurea pulse therapy with~     that of imatinib in treating chronic-phase CML patients.~   "
3963|NCT03515005|"~     Hypertension disproportionately affects and is inadequately controlled among African American~     and poor populations. The investigators propose to determine the impact of using trained lay~     health advisors to help patients address social contextual factors that influence the~     management of hypertension.~   "
3964|NCT03514992|"~     Children who attend School-Based Occupational Therapy (SBOT) show mixed dominance and a~     liable decreased in the structural and functional differentiation between the two~     hemispheres. The lack of right-left disparity has been found to link to mirror invariance,~     poor spatial organization, fragmentary reversals, and handwriting difficulty. This study~     intends to find out, whether, Sensory Motor Lateralization (SML), With a rightward bias,~     profits handwriting more than the conventional (CON) Without.~   "
3965|NCT03514979|"~     This study will address the following hypothesis: Rituximab therapy leads to an acquired~     immune deficiency, as demonstrated by impaired vaccine responses, in AAV patients.~      Aims:~        1. To investigate whether rituximab leads to immune deficiency in patients with AAV when~          compared to both disease and healthy controls.~        2. To investigate whether the degree of immune deficiency is associated with the degree of~          B cell depletion.~        3. To investigate whether T-independent vaccine responses are more severely affected than~          T-dependent vaccine responses after rituximab and whether a conjugated vaccine will~          overcome this postulated deficit in T independent vaccine responses.~   "
3966|NCT03514966|"~     By comparing dimethicone administration with/without subsequent repetitive position change~     before magnetically controlled capsule endoscopy (MCE) examination, the investigators aim to~     determine the efficacy of repetitive position change in improving image quality for gastric~     preparation in patients receiving MCE examination.~   "
3967|NCT03514953|"~     The proposed research will examine the role of physical activity (PA) on altering sleep~     quality (SQ) while systematically examining novel mechanisms that may drive changes in SQ.~     Specifically, the study will examine how a 2 week reduction in PA alters sleep quality in~     young, healthy individuals. Additionally, during this reduction in PA, the study will examine~     changes in inflammation, oxidative stress, and sympathetic activity to identify potential~     mechanisms for alterations in sleep quality.~   "
3968|NCT03514940|"~     fetal gastro intestinal abnormalities can be accurately diagnosed in second trimester~   "
3969|NCT03514927|"~     This phase II trial studies how well high-intensity focused ultrasound works in treating~     participants with intermediate and high-risk prostate cancer. High-intensity focused~     ultrasound uses high frequency sound waves to deliver a strong beam which may target and~     destroy a specific part of the prostate, while minimizing damage to surrounding structures~     and tissue.~   "
4014|NCT03514342|"~     This study evaluates the effects of Horner's syndrome on cardiac autonomic nervous activity~     after interscalene brachial plexus block. Cardiac autonomic nervous activity and bilateral~     pupil diameters will be measured in a scotopic light condition, 30 minutes after interscalene~     brachial plexus block under ultrasound guidance.~   "
3970|NCT03514914|"~     Globally, 41% of all pregnancies are unintended, increasing risk for maternal and infant~     morbidity and mortality. Most unintended pregnancies occur in the context of contraceptive~     non-use or failure. Women with husbands who are not supportive of contraception are more~     likely to report contraceptive non-use, and women with sexually abusive husbands are more~     likely to report contraceptive failure. This highlights the need for family planning (FP)~     interventions that engage both women and men, focus on eliminating marital sexual violence~     (MSV) and promote use of effective contraceptives including long-acting reversible~     contraception (LARC). Rural India, with some of the lowest rates of contraception and highest~     rates of marital violence globally, offers an important context to test such interventions,~     with global implications. Prior research from this team documents promise of the original~     CHARM intervention, a gender equity (GE) FP intervention engaging men and delivered by male~     health providers over 3 months. This intervention improved contraceptive use and reduced~     likelihood of MSV, but demonstrated no reduction in unintended pregnancy; additionally, it~     demonstrated high participation from men (91%) but less from couples (51%), largely due to~     women's discomfort with a male provider. Poor reach to women and provision of only~     short-acting contraceptives, more vulnerable to contraceptive failure, may have compromised~     an effect on unintended pregnancy outcomes. Based on these findings, CHARM2 includes CHARM~     sessions for men AND parallel women-focused GE+FP sessions delivered by a female provider and~     inclusive of broader contraceptive options, including LARC. This study seeks a) to implement~     CHARM2, b) to evaluate its impact on contraceptive use, unintended pregnancy, and MSV with~     rural couples in India, and c) to assess its potential for sustainability in rural India,~     using implementation science methods.~      To evaluate the impact of CHARM2, a 2-armed cluster randomized controlled trial will be~     conducted with up to N=1200 married couples from 20 geographic clusters (n=50-60 couples per~     cluster) in rural India. Participants will receive CHARM2 or the standard of care, which will~     involve community health workers offering pills/condoms and linking women to public health~     clinics. Outcomes will be assessed via pregnancy testing and surveys at baseline, 9 &~     18-month follow-ups. Implementation science methods will assess the quality, scalability, and~     replicability of CHARM2 for uptake by rural health care systems (i.e., sustainability).~   "
3971|NCT03514901|"~     The purpose of this study is to evaluate the efficacy beyond progression of vemurafenib~     combined with cobimetinib associated with local treatment compared to second-line treatment~     in patients with BRAFV600 mutation-positive metastatic melanoma in focal progression with~     first-line combined vemurafenib and cobimetinib.~   "
3972|NCT03514888|"~     This is a non-randomized, non-blinded, pilot study administering hyperthermic intraperitoneal~     chemotherapy with Mitomycin-C in 10 men and women with muscle-invasive urothelial carcinoma~     of the bladder undergoing radical cystectomy with pelvic lymph node dissection who have risk~     factors for tumor recurrence.~   "
3973|NCT03514875|"~     Neurodegenerative diseases such as Alzheimers and dementia affect millions of Americans.~     Although these diseases are heavily researched, there is very little research examining the~     impact of attenuated carotid artery endothelial function and cerebrovascular blood flow on~     cognitive function. This is surprising, as cerebrovascular oxygenation has been shown to be~     strongly associated with reduced cognitive function and the pathogenesis of neurodegenerative~     diseases. For example, hypertension, diabetes, and high cholesterol have been shown to~     increase the risk of Alzheimers related dementia. Therefore, the purpose of this proposed~     study will be to examine the effects of MitoQ supplementation on carotid artery vasodilatory~     function and cerebrovascular blood flow in those suffering from Alzheimer's disease. MitoQ is~     a mitochondria-targeting antioxidant that can improve nitric oxide production in the blood~     vessel, which should improve endothelial function, and thus cerebrovascular blood flow.~   "
3974|NCT03514862|"~     In this project, the investigators propose to evaluate the impact of a Mindfulness-Based~     Intervention (MBI) Program on the well-being of University of Miami (UM) clinicians and~     faculty/staff. If successfully implemented and proven to be effective, this training program~     may be disseminated to other interested medical personnel.~   "
3975|NCT03514849|"~     At present, for participants with cT1-2N0 small cell lung cancer (SCLC), the International~     guidelines recommend surgical radical resection (lobectomy + systematic lymph node sampling~     or cleaning); If the postoperatively pathological examination is confirmed to be in pT1-2N0~     stage, a single postoperative adjuvant chemotherapy (combining etoposide with cisplatin) is~     recommended. If participants are difficult to tolerate the side effects of cisplatin, the~     investigators can replace cisplatin by carboplatin in the adjuvant chemotherapy scheme.~     Participants with pT1-2N0 SCLC are not recommended to receive postoperative chest-assisted~     radiotherapy. For participants with pT1-N0 SCLC after specific surgical resection,~     prophylactic cranial irradiation (PCI) is currently recommended. But this recommendation is~     currently lacking the support of research evidence.~      The main purpose of this study is to study the prognostic effects of PCI on participants with~     pT1-2N0 stage small cell lung cancer (SCLC) who have received radical surgery and~     postoperative adjuvant chemotherapy.~      The main endpoint of this study is to observe the total survival rate (5-year OS%) in 5~     years.~      The secondary outcome measures include 5 years of disease-free survival (5-year DFS%),~     disease-free survival (DFS), overall survival (OS), surgical complications, resection rates,~     quality of life (QoL), and exploration of biomarkers (tumor tissue).~      This is a two-arm, open, multicentral clinical study designed to compare the 5-year OS% of~     participants receiving or not receiving PCI for pT1-2N0 stage small cell lung cancer (SCLC)~     with radical surgery plus postoperative adjuvant chemotherapy. Previous literature reports~     that the 5-year OS% of participants with pT1-2N0 period SCLC who have received surgical~     resection is about 50%. Assuming that PCI can increase 5 years OS% by 10%, then enrolling 320~     participants in the group can guarantee 70% degree of certainty with observing a unilateral~     significant difference α< 0.1. Taking about 10% of the follow-up loss rate into account, the~     investigators expect to enroll 360 participants.~      Dividing the 360 participants divided into two groups randomly, each group is composed of 180~     people. All participants received lobectomy plus mediastinal lymph node dissection or~     systematic lymph node sampling. Participants in the control group are enrolled in the~     follow-up, and the participants in research group will receive PCI by 25gy/10fx.~   "
3976|NCT03514836|"~     This clinical trial is to evaluate the safety of the combination of DCVAC/PCa with ONCOS-102~     in men with castration-resistant advanced metastatic prostate cancer, who have progressed~     following initial therapy with either hormones (e.g. abiraterone and enzalutamide) or~     chemotherapy.~      Male patients with castration-resistant advanced metastatic prostate cancer, who have~     progressed following initial therapy with either All patients must have at least one readily~     accessible soft tissue/nodal tumor lesion (for intra-tumoral application of ONCOS-102 and~     biopsy.~   "
3977|NCT03514823|"~     The investigators seek to understand how reflexes from the breathing muscles influence blood~     pressure during exercise. Furthermore, the investigators are determining if increasing~     breathing muscle strength (via inspiratory muscle training) influences the respiratory muscle~     contribution to blood pressure during exercise.~   "
3978|NCT03514810|"~     Among the major depressive disorder (MDD) patients in the follow-up group, 16 were~     administered with 50 mg of oral sertralin once daily with placebo, whereas 28 were treated~     with 100 mg of ketoprofen once daily as adjuvant treatment for MDD. Controls do not take any~     medicine.~   "
3979|NCT03514797|"~     This parallel, randomized, and controlled clinical trial will assess the effect of a single~     prior session of in-office dental bleaching on time required to achieve satisfactory tooth~     color with at-home bleaching. Participants enrolled will randomly allocated to receive or not~     a single session of dental bleaching with 35% hydrogen peroxide applied for 45 min.~     Following, all participants will use customized trays filled with 10% carbamide peroxide for~     1h per day until obtain satisfactory results. The primary outcome will be the number of days~     necessary to obtain satisfactory tooth color. Furthermore, tooth sensitivity and color~     changes measured with spectrophotometer will be assessed.~   "
9977|NCT03436225|"~     The aim of the present study is to evaluate the efficacy of steroid therapy and hospital stay~     in patients with acute bronchiolitis at assiut university children hospital.~   "
3980|NCT03514784|"~     This protocol is a blinded randomized controlled study of the effects of BB-12 with LGG at~     different doses in 70 healthy children with autism spectrum disorders at lower and higher~     doses over an 56-day period and a 28- day observation period. The study is being conducted in~     order to assess safety and tolerability of the probiotic (BB-12 with LGG) at 2 different~     doses of BB-12 with LGG. Identifying effects on behaviors in healthy children with ASD using~     SRS-2 and ABC, GI symptoms using GI symptom severity index, and relevant biomarkers of~     inflammation, microbiota, and metabolites. Primary testing and procedures will be conducted~     at the University of Texas Health Science Center at Houston and Memorial Hermann Clinical~     Research Center.~      Biomarker identification includes Integrative analysis of plasma metabolome and stool~     microbiota will be conducted with the collaboration of Dr. Ruth Ann Luna and Dr. Jim~     Versalovic at Alkek Center for Metagenomics and Microbiome Research, Department of Molecular~     Virology & Microbiology of Baylor College of Medicine.~   "
3981|NCT03514771|"~     Patients who have completed have completed a cumulative dose of >=120miligram/kilogram oral~     isotretinoin within the last 30 days, and has mild to moderate acne scarring will be~     randomized, into a right-left comparison study using Fraxel DUAL (Solta Medical) laser on one~     side of the face, and no treatment on the other side of the face. Subejcts will receive~     treatments at week 0, week 4, and week 8. Photographs will be taken after each treatment, 7~     days after each treatment, and 4 months after last treatment. Photographs will be reviewed by~     blind assessors who will analyze the pre- and post-treatment photographs to measure change.~   "
3982|NCT03514758|"~     A methodical evaluation of novel sound changing principles in CE-labelled Sonova brand~     hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing~     impaired participants. These sound changing principles are enabled by respective hearing~     instrument technologies and hearing instrument algorithms. The aim of the study is to~     investigate and assess strengths and weaknesses of these novel sound changing principles in~     terms of hearing performance to determine their application in hearing instruments (Phase of~     development). Both, objective laboratory measurements as well as subjective evaluations in~     real life environment will be carried out. This will be a controlled, single blinded and~     randomised active comparator clinical evaluation which will be conducted mono centric at the~     University Hospital of Zürich.~   "
3983|NCT03514745|"~     We evaluate the GlideScope and lighted stylet for DLT intubation in terms of the intubation~     time, number of intubation attempts, difficulty in DLT advancement towards the glottis,~     postoperative sore throat and hoarseness, and hemodynamic responses during intubation in~     patients with predicted difficult airways.~   "
3984|NCT03514732|"~     Primary Objective:~      To estimate the range of improvement of NOVANUIT® triple action on sleep quality global~     score.~      Secondary Objectives:~        -  To estimate the range of improvement of NOVANUIT® triple action on following parameters:~          time for getting asleep, sleep time, number of nocturnal awakening, number of~          nightmares, sleep quality (score from 0 to 10), and mean tiredness during the day (score~          from 0 to 10).~        -  To estimate persistency of NOVANUIT® triple action effects after end of study product~          consumption.~        -  To assess dependency to NOVANUIT® triple action after study product cessation.~        -  To assess tolerance of NOVANUIT® triple action during the study.~   "
3985|NCT03514719|"~     In this feasibility study, a 89Zr-avelumab PET scan will be performed in 37 patients prior to~     treatment with avelumab to:~        1. assess the tumor and systemic tissue uptake 89Zr-avelumab~        2. assess the potential to predict avelumab treatment response~   "
3986|NCT03514706|"~     Volume controlled ventilation (VCV) and pressure controlled ventilation (PCV) are the common~     ventilatory modes during OLV undergoing thoracic surgery. A controversy regarding which~     ventilation mode is better for oxygenation during OLV with PCV enhances oxygenation more than~     VCV ;given its initial high peak inspiratory flow rates and its rapidly decelerating flow~     pattern. However, this high peak inspiratory flow rate might also provoke lung injury via~     shearing and traction forces on the alveoli. Extravascular lung water describes water within~     the lungs but outside pulmonary vasculature. Lung ultrasound (LUS) assessment of EVLW by~     B-lines provides a reliable and easy alternative.~   "
3987|NCT03514693|"~     This study examines non-inferiority of pulmonary vein isolation (PVI) for persistent atrial~     fibrillation (AF) to extensive ablation; and reveals the effect of the presence or origin of~     AF trigger on outcomes of catheter ablation.~   "
3988|NCT03514680|"~     This research study is evaluating how well a decision support tool works to improve~     clinicians' use of recommended chemotherapy-induced peripheral neuropathy (CIPN) assessment~     and management strategies in participants receiving chemotherapy.~   "
3989|NCT03514667|"~     Metabolic syndrome is a public health challenge that includes a range of conditions including~     abdominal obesity, dyslipidemia, hyperglycemia, and hypertension. The syndrome is associated~     with an increase in the risk of Cardiovascular disease and death. Curcumin is a very active~     compound obtained from turmeric root. Curcumin has antioxidant and anti-inflammatory effects,~     and is also involved in the regulation of several signaling pathways. Since curcumin powder~     has low bioavailability, fast metabolism and low absorption, nanomicielle curcumin will be~     used in this study. Therefore, this study is planned to determine the effects of~     supplementation of nanomicielle curcumin on oxidative stress, systemic inflammation,~     adiponectin in serum and NF-kB in peripheral blood mononuclear cells in patients with~     metabolic syndrome.~   "
3990|NCT03514654|"~     Sometimes women have more than one breast cancer in the same breast at the same time. These~     women are usually offered a mastectomy (removal of that breast) and breast reconstruction. It~     may be possible to treat these patients by removing each cancer using breast-saving surgery~     (lumpectomies), used for women with only one breast cancer. Databases show that women who had~     lumpectomies did well, but they may have been healthier before the surgery than those who had~     a mastectomy. The investigators need to be sure that lumpectomy is effective, safe, and~     acceptable for this patient group before making it universally available.~   "
3991|NCT03514641|"~     This integrated assessment consists of two studies, 603A and 603B, to be carried out~     sequentially in a common study population. Participating subjects will be informed of the~     trial design and their consent to participate in both studies will be obtained in a single~     consent form. Approximately 680 male or female adult subjects will be enrolled.~   "
3992|NCT03514628|"~     The Valsalva Assist Device (VAD) is a simple hand held device, designed to assist in the~     physical treatment of a common, fast heart rhythm disorder called supraventricular~     tachycardia (SVT).~      This treatment, called the Valsalva manoeuvre (VM), is a safe, physical technique involving a~     forced exhalation against resistance (like that required to blow up a balloon). This causes a~     reflex slowing of the heart and can correct attacks of SVT (cardioversion). It is an~     internationally recommended initial treatment but previously has had a low success rate~     (5-27%) and patients often have to be taken to hospital for drug treatment.~      Recent hospital research has demonstrated that a VM carried out using a certain level of~     strain pressure(40mmHg) measured with a blood pressure manometer, combined with a simple~     postural modification (the modified VM) gives a far better chance of success (43%) and avoids~     the need for drug treatment. More practical methods of generating this strain such as blowing~     on an empty syringe have been used but are unreliable. The Valsalva Assist Device (VAD) has~     been designed to provide the correct resistance and is packaged with instructions for the~     modified VM.~      Attacks of SVT frequently occur without warning in otherwise healthy people. Patients are~     often initially seen by ambulance staff and so the use of the VAD therefore represents an~     opportunity to provide ambulance clinicians with instructions for the modified VM and a means~     to deliver the correct strain in one, easy to use device.~      The investigators plan to test use of the device in patients with an attack of SVT and~     attended by paramedics or other pre-hospital practitioner, compared to current recommended~     practice. This project will provide important feasibility and recruitment data for a~     definitive trial, assessing the performance of the VAD on SVT cardioversion and conveyance~     (transfer to hospital) rates.~   "
3993|NCT03514615|"~     This will be a single centre, double-blind, placebo (vehicle) controlled, randomised, dose~     escalation trial. Three concentrations of topical salbutamol gel will be compared, in a~     group-wise fashion, with a placebo administration at one incision site on each arm of the~     trial subjects. Each participant will be allocated to only one dosing group. The treatments~     will be paired anatomically so that for each pair of sites, one closed incision site will~     receive the active substance, while the other will receive placebo.~   "
3994|NCT03514602|"~     The objective of this study is to test the effect of smoking cessation in pregnancy or in~     lactation on preventing rapid infant adiposity gain. Investigators propose a randomized,~     controlled experiment among smoking pregnant women from 1st prenatal care visit through 6~     months of postpartum period. Two-phase randomization will be applied to separate the effects~     of smoking cessation in two different critical periods (i.e., pregnancy and lactation) on~     infant adiposity gain. Investigators will first randomly assign 40 smoking pregnant women~     into either the multicomponent intervention (N=30) or the education-only control group~     (N=10). The multicomponent intervention group will receive education and counseling,~     monitoring and feedback, contingent financial incentives, and family support, while the~     control group will receive education only. At the end of pregnancy, investigators will~     further randomize successful quitters (estimated N=20) from the multi-component intervention~     group into either the continuous multi-component intervention group in lactation (N=10) or~     the education-only control group (N=10). All women and their newborns will be followed from~     enrollment to 6 months postpartum. The key outcomes include maternal smoking abstinence~     confirmed by urine-cotinine and infant gain in weight-for-length z-score. Specific Aim 1 is~     to examine the effects of maternal smoking cessation intervention in pregnancy on infant gain~     in weight-for-length z-score from birth to 6 months. Specific Aim 2 is to examine the effect~     of maternal smoking abstinence intervention in lactation and infant post-weaning gain in~     weight-for-length z-score among the women who have successfully quit smoking in pregnancy.~   "
3995|NCT03514589|"~     Recently there has been concern about the effect of inhaled steroids, routinely used in the~     treatment of asthma, on the body's ability to produce its natural stress hormone cortisol.~     Failure of adequate cortisol production in times of stress e.g. illness, can result in~     serious illness or death. Patients receiving longterm steroid treatment may have reduced~     levels of cortisol and not be able to produce adequate amounts in times of need, a process~     called adrenal suppression. Initially it was thought that the absorption of inhaled steroids~     into the bloodstream would be too low to cause adrenal suppression however high profile~     deaths followed by a national survey revealed a number of fatal or near fatal cases of~     adrenal suppression. The vast majority of these were in children. Since then doctors have~     been encouraged to ensure that children on high doses of inhaled steroids carry a steroid~     alert card and that the ability of their adrenal glands to produce adequate amounts of~     cortisol is checked. However it is unknown what dose of inhaled steroids puts one at risk,~     whether age or gender affects one's risk and when to check the function of the adrenal gland.~      The Short Synacthen Test (SST) investigates the ability of the body's adrenal glands to~     produce cortisol. Presently the SST requires intravenous (i.v) cannulation through which~     Synacthen is injected to stimulate the adrenal glands and multiple blood samples are~     collected to assess the response in terms of cortisol production. It is invasive, time~     consuming and unpleasant for the child. Our project aims to produce a noninvasive alternative~     to the current SST, with Synacthen given nasally and using saliva to measure the subsequent~     production of cortisol. A noninvasive test will allow us to establish the first normal ranges~     for children and determine which children with asthma are at risk of adrenal suppression.~   "
3996|NCT03514576|"~     Postprandial hyperinsulinemic hypoglycemia is a well-known and potentially severe~     complication of Roux-en-Y gastric bypass (RYGB), and the treatment options are limited.~     Pasireotide has shown to be effective in preventing hypoglycemia in RYGB operated subjects,~     however treatment often leads to increased hyperglycemia.~      The purpose of this study is to investigate two doses of pasireotide that are lower than~     doses previously used in RYGB operated subjects with postprandial hyperinsulinemic~     hypoglycemia.~   "
3997|NCT03514563|"~     Cleft lip and palate is the most common facial birth defect affecting one in 700 babies, and~     frequently leads to problems in feeding, breathing, speech and/or hearing, and aesthetic~     problems often leading to social and psychological problems. Poor growth of the upper jaw~     affects nearly all patients with the condition, and can result in substantial misalignment of~     the teeth requiring corrective surgery and associated dental treatment in early adulthood.~      Surprisingly there is little evidence to support the current practice of delaying surgery~     until early adulthood. It is apparently left until then because it is assumed this is when~     the skull and face have stopped growing, but there is little available information on that~     growth and when the different parts of the face and skull stop growing.~      The goal of this study is to develop and test new computer-based methods to quantify skull~     growth and related soft- tissues changes. This pilot work will demonstrate whether it is~     possible to measure these developments and prepare the tools for a larger clinical study.~     That clinical study will determine the full nature and extent of bone growth and related~     soft-tissue changes during late adolescence, to identify if/when earlier surgery could be~     carried out to correct any deformity and minimise the associated social stigmas of the~     condition.~   "
3998|NCT03514550|"~     The aim of the study is a comparative study of the cellular immunity response of patients~     operated on for kidney cancer under total intravenous and inhalational anesthesia.~   "
4064|NCT03513692|"~     The trial compares patient-reported postoperative sensitivity of 2 existing dental filling~     materials. The dental filling materials will be used according to manufacturer's instructions~     and within the existing CE marked licence. We are interested in investigating which licensed~     material confers the least postoperative discomfort to our patients in normal clinical use.~   "
3999|NCT03514537|"~     With increasing age and health issues associated with aging, many systemic cellular and~     structural changes are known to occur. The intent of this trial is to determine the safety~     and efficacy of delivery of autologous cellular stromal vascular fraction (cSVF) to improve~     the quality of life and functional health.~      Isolation and concentration of cSVF will be documented.~      To acquire autologous cSVF, a 10+ teaspoon volume of subdermal adipose (fat) tissue and~     stroma is removed from the trunk or upper thigh area. Using a closed system with enzymatic~     digestion to isolate and concentrate these cells, is followed with returning these cSVF~     elements only via 500 cc Normal Saline delivered via peripheral vein (IV).~      Documentation of cellular numbers and flow cytometer viability testing is to be correlated~     with clinical outcomes as reported by patients and standardized Quality of Life (QoL) form~     tracking~   "
4000|NCT03514524|"~     Alzheimer's disease, stroke and TBI are frequently observed brain disorders, causing~     significant morbidity. For none of these disorders, there are in vivo diagnostic biomarkers~     available that allow determination of disease burden, patient-specific prognosis and therapy~     follow-up. However, they all share a similar mechanism that may cause accumulation of tau~     oligomers in the brain, synaptic dysfunction and cognitive and/or behavioral impairment.~     Until recently, the only way to quantify synaptic density and tau deposition was using~     post-mortem immunohistochemistry. Now, in vivo Positron Emission Tomography (PET) imaging of~     synaptic density has become possible trough development of 11C-UCB-J, a levetiracetam-based~     radioligand, expressing high affinity and specificity for SV2A. Furthermore, the novel~     radioligand 18F-MK-6240, specifically targeting tau deposits, was clinically implemented in~     our center. Through PET-MR, we can visualize the cascade of tau deposition, synaptic loss and~     degeneration of grey and white matter and relate these pathologic features to cognitive and~     behavioral deterioration. The goal of the study is to: 1) measure tau deposition and loss of~     synaptic density in these conditions as a potential measure for disease load 2) determination~     of the mid-term (2 years) monitoring capacity of combined functional-structural PET-MR~     imaging 3) relate progression of the imaging markers to cognitive and/or behavioral decline~     and 4) determination of the optimal combination of PET-MR metrics for early identification~     and risk-stratification of cognitive and/or behavioral dysfunction in de novo patients.~   "
4001|NCT03514511|"~     The primary objective of this trial is to investigate the safety and tolerability of LEO~     138559 in healthy subjects and subjects with moderate to severe atopic dermatitis.~      The secondary objective of this trial is to study the pharmacokinetics and pharmacodynamics~     following administration of LEO 138559 to healthy subjects and subjects with moderate to~     severe atopic dermatitis.~      Healthy subjects will be exposed to 7 different dose regimens of LEO 138559 (one dose regimen~     per subject).~      Subjects with moderate to severe atopic dermatitis will be exposed to 2 different dose~     regimens of LEO 138559 (one dose regimen per subject).~   "
4002|NCT03514498|"~     As anesthesia is often needed for childhood surgery and procedures, researchers have examined~     the potential effects of anesthesia on neurodevelopment. There are few studies that have~     examined the effect of anesthesia on neurodevelopment in children with confirmed diagnoses of~     ASD, and the results of these studies are mixed. Children with neurodevelopmental disorders~     can have age-dependent variations in brain anatomy, function, and connectivity, which may~     alter their sensitivity to the potential neurotoxic effects of anesthetic and sedative drugs.~     Given the potential adverse neurodevelopmental effects of anesthesia on typically developing~     children, it is important to examine if anesthesia exposure can worsen the clinical course of~     ASD.~   "
4003|NCT03514485|"~     This project uses community health workers (CHW) or lay health educators to implement asthma~     interventions that have been proven to work in the primary care setting and in schools. The~     objective is to integrate the home, school, healthcare system, and community for 600~     school-aged asthmatic children in West Philadelphia through use of CHWs.~      The children enrolled in the study will be randomized to one of four groups including:~     primary care CHW, school CHW, primary care and school CHW or the control group (no CHW).~   "
4004|NCT03514472|"~     This research project is aimed at combating the nutritional deficiencies (Iron deficiency~     anemia) of reproductive aged females belonging to the underprivileged group of the society.~     Since anemia is one of the causes of still child-birth, preterm and low birth weight babies~     causing cognitive disabilities during the later years of life, So, it needs to be treated on~     priority bases.~   "
4005|NCT03514459|"~     Cervical cancer is the most common cancer in women in sub-Saharan Africa, and the majority of~     cervical cancer mortality occur in low and middle income countries (LMICs). Many of the~     disparities between high and LMICs are attributed to differences in screening. Kenyan~     guidelines recommend screening with visual inspection methods followed by treatment of~     pre-cancerous lesions with cryotherapy and loop electrosurgical excision procedure (LEEP).~     Implementation of these are poor with only 14% of Kenyan women ever having been screened for~     cervical cancer as of 2014. To address this implementation gap, this application proposes~     three aims. In Aim 1, the investigators will describe the cervical cancer screening care~     cascade, from identification of female clients age 21-65 years old, through referral for~     follow-up of clients with positive or suspicious screens, in family planning (FP) clinics in~     Mombasa County. Following characterization of this cascade, an analysis will be conducted of~     correlates of failure to screen for cervical cancer in FP clients seen over a one-year period~     in Mombasa County. Aim 2 will test whether SAIA increases cervical cancer screening compared~     to usual procedures in a cluster randomized trial in 20 FP clinics in Mombasa County.~     Finally, in Aim 3, the investigators will determine the cost and budget impact of using SAIA~     to increase cervical cancer screening in FP clinics in Mombasa County. The results of this~     study have the potential to improve cervical cancer screening, and inform policy in the~     Mombasa DOH for a fiscally responsible evidenced-based approach for cervical cancer~     screening. The long-term goal is to decrease cervical cancer mortality and improve women's~     health.~   "
4015|NCT03514329|"~     This study is a prospective, single-arm, multi-center, pilot trial of Bronchoscopic Thermal~     Vapor Ablation for Lung Cancer (BTVA-C) in patients with primary lung cancer or metastatic~     cancer in the lung. Patients who have consented to participate in this study (enrolled) will~     be subject to eligibility screening and baseline assessments, prior to undergoing the BTVA-C~     procedure. Only patients that meet all of the inclusion criteria and none of the exclusion~     criteria will receive vapor ablation treatment.~      Patients will be followed for up to 12 months.~   "
4006|NCT03514446|"~     Introduction: Staphylococcus aureus bacteremia (SAB) plays an important role in long-course~     antibiotic therapy. Current international guidelines recommend fourteen days of intravenous~     antibiotic treatment for SAB in order to minimize risks of secondary deep infections and~     complications. However, patients with simple SAB are known to have a low risk of~     complications. Reducing treatment length in uncomplicated SAB would reduce the total~     consumption of antibiotics, adverse events and duration of hospital admission. SAB7 seeks to~     determine if seven days of antibiotic treatment in patients with uncomplicated SAB is~     non-inferior to fourteen days of treatment.~      Method: The study is designed as a randomized, non-blinded, non-inferiority interventional~     study. Primary measure of outcome will be failure to treatment or recurrence of SAB twelve~     weeks after termination of antibiotic treatment. As a measure of secondary outcome the~     prevalence of severe adverse effects will be evaluated, in particular secondary infection~     with Clostridium difficile, mortality as well as public health related costs. Patients~     identified with uncomplicated SAB, are randomized 1:1 in two parallel arms to seven or~     fourteen days of antimicrobial treatment, respectively. Endpoints will be tested with a~     statistical non-inferiority margin of 10%.~      Conclusion: SAB 7 will determine if seven days of antibiotic treatment in patients with~     uncomplicated SAB is sufficient and safe, potentially modifying current treatment~     recommendations.~   "
4007|NCT03514433|"~     The TRIP Project aims to overcome barriers to widespread implementation and dissemination of~     evidence-based practices that will improve the delivery of guideline-concordant care to~     vulnerable women with breast cancer. To accomplish this goal the study team will create (a)~     regional patient registries; (b) systematic screening for social barriers to care with a~     personalized referral plan; and (c) patient navigation services that integrate into one model~     of care to improve the quality and effectiveness of care delivery, for minority and/or~     low-income women with breast cancer in Boston.~   "
4008|NCT03514420|"~     This is a multi-center, open-label study to evaluate the efficacy of AKCEA-ANGPTL3- LRX for~     reduction of fasting triglycerides in patients with Familial Partial Lipodystrophy.~   "
4009|NCT03514407|"~     The purpose of this study is to evaluate the safety and preliminary antitumor activity of~     INCB059872 or INCB057643 in participants with Ewing sarcoma who are refractory or relapsed~     from prior standard therapy and not eligible for further standard systemic therapy.~   "
4010|NCT03514394|"~     Evidence-based psychosocial interventions (EBPI) are rarely used in part because of their~     design complexity. Although many implementation frameworks do address the importance of EBPI~     characteristics, adapting and modifying EBPIs to enhance usability has not been a focus.~     User-centered design (UCD) approaches, which have been successful in creating hardware and~     software tools that are accessible and compelling to use, have the potential to modify EBPIs~     so that they are accessible and compelling to clinicians. The investigators hypothesize that~     UCD driven modifications to EBPI usability (target mechanism) will result in enhanced~     clinician ability to deliver EBPI elements competently, and that better competence results in~     better patient reported outcomes. The investigators will modify Problem-Solving Therapy for~     Primary Care (PSTPC) because it is the EBPI used in Collaborative Care (CC). Our aims are to~     (1) identify usability problems clinicians encounter with PST-PC (2) create a clinician~     driven modification of PST-PC and (3) compare the modified version of PST-PC to traditional~     PST-PC on usability, clinician competence and patient reported outcomes.~   "
4011|NCT03514381|"~     This trial is a multicentric study aiming to assess the evolution of the serum ifosfamide~     concentrations and its serum metabolites in patients treated for an Soft Tissue Sarcoma and~     co-exposed to Aprepitant.~      The study will be conducted on a population of patients treated with Doxorubicin and~     Ifosfamide. The Aprepitant can be prescribed to patients from cycle 2, according to the~     current recommendations. Doxorubicin, Ifosfamide and Aprepitant will be administered in the~     context of routine care. The follow-up during the treatment period and the clinical,~     biological and radiological assessments will be performed according to the standard of each~     centre.~      Patients will be followed during the two first cycles of treatment. For the pharmacokinetic~     study, blood samples will be collected at different time points during the 2 treatment~     cycles.~   "
4012|NCT03514368|"~     This trial is a translational, open-label, multi-site, prospective cohort study of 440~     patients aiming to identify and to monitor immunological biomarkers associated with~     therapeutic response to immune checkpoints blockade (ICB), in patients with multiple types of~     advanced (unresectable and/or metastatic) solid cancers.~      The study will be conducted on a population of patients receiving ICB (anti-PD-1 or~     anti-PD-L1 or anti-CTLA4, alone or in combination) in the context of either routine care or a~     clinical study protocol.~      Patients with any of the following tumor types may be enrolled in the trial:~        -  Non-Small Cell Lung Cancer (NSCLC),~        -  Head and neck cancer,~        -  Melanoma,~        -  Bladder cancer,~        -  Other tumor types when Immuno-Oncology agent is expected to be efficient or when a~          clinical trial is an option.~      For each included patient, tumor biopsy specimens and blood samples will be collected at~     different time points.~      All included patients will be followed-up until progression. After this date, survival data~     will be collected.~   "
4013|NCT03514355|"~     Despite their efficacy at controlling joint inflammation, current treatments of rheumatoid~     arthritis (RA) leave up to 40% of patients into non-remission.~      Non-remission is most frequently due to persistently negative self-reported global impact of~     RA, and not to remaining swollen joints or elevated levels of acute phase reactants. In a~     cohort of recent-onset RA patients diagnosed early and treated to remission (Sherbrooke Early~     Undifferentiated PolyArthritis (EUPA) cohort), treatment of active disease rapidly led to~     reduced depressive symptoms in most, but 20% still expressed elevated depressive symptoms~     (using the CES-D screening tool) after a mean of 7 months. Elevated CES-D scores at this~     early time strongly predicted never reaching remission over the following 4 years. Elevated~     CES-D scores were strongly correlated with increased levels of patient-related outcomes (PROs~     such as fatigue, pain, sleep quality, stiffness and functional limitation), but not with~     joint or systemic inflammation. In fact, 80% of patients expressing depressive symptoms had~     controlled joint disease at the same visit. The investigators propose that addressing~     depressive symptoms will improve RA patients' symptoms and quality of life. In clinical~     practice, the best indicator of depressive symptoms is the presence of a disconnect between~     the Patient's (Pt-VAS) and the Physician's (MD-VAS) evaluation of disease activity in~     patients without objective signs of inflammation.~      This pilot study will explore the feasibility and acceptability of testing MBSR in these~     patients. It will assess over 6 months the changes in depressive symptoms and PROs both in~     controls and MBSR-treated patients. If positive, the investigators plan to complete a~     multicenter 6-month Randomized Clinical trial (RCT) (with a 2 year follow up) to formally~     address the risks/benefits of group MBSR interventions in RA patients with controlled~     inflammatory disease but positive disconnect between Pt-VAS and MD-VAS.~   "
15123|NCT03368950|"~     A feasibility study to investigate the effect of an online mindfulness programme~     (www.bemindfulonline.com) on stroke survivors' mental and physical wellbeing.~   "
4016|NCT03514316|"~     Patients undergoing orthodontic treatment with fixed appliances usually develop gingival~     enlargement (GE). Its development is usually attribute to chronic inflammation, and may cause~     both esthetic and functional problems for the patient. In many cases, the gingival~     hyperplasia demands periodontal surgery in order to increase the length of the crown during~     or after the orthodontic treatment. Previously conventional surgical procedures were~     performed using a scalpel under local anaesthesia for these procedures. Lately the use of~     laser has been proposed. The majority of the studies comparing laser gingivectomy with~     scalpel gingivectomy show some limits: they are not randomized, they are not prospective, and~     they have no control group. The primary objective of the present investigation was to conduct~     a randomized controlled trial (RCT) evaluating the effectiveness of diode laser gingivectomy~     versus scalpel gingivectomy in the management of periodontal health among patients receiving~     fixed orthodontic appliance therapy, compared with a non surgical control group.~   "
4017|NCT03514303|"~     The purpose of this study is to evaluate the potential correlation of the results of~     allergen-specific skin prick tests (SPT) to that of allergen-specific microarray~     determination (microassay test). Subjects who meet enrollment criteria, after signing an IRB~     approved consent form, will perform a minor finger prick blood draw and blot to be mailed off~     for microassay analysis. Specific statistical analysis will be done to assess all potential~     correlations between SPT and microassay. This study design should enable assessment of the~     level of correlation between SPT results and microassay results for specified allergens~     within a cohort of subjects with allergic rhinitis.~   "
4018|NCT03514290|"~     Objective: The objective of this clinical study was to evaluate low-level laser (LLL) therapy~     in tooth sensitivity and in effecting color change after in-officer bleaching treatment~     across three weeks of treatment.~      Methods: Twenty-one volunteers were evaluated through the split-mouth model, so that the~     right and left maxillary/mandibular quadrants were randomized and allocated to one of two~     groups: GPLACEBO - the laser tip was positioned without the emission of light (placebo~     effect) + tooth bleaching with 35% hydrogen peroxide (HP); GLASER - treated with LLL + tooth~     bleaching with 35% HP. To assess tooth sensitivity, a modified visual analogue scale (VAS)~     was used after an evaporative stimulus (stimulated pain) and a daily pain questionnaire~     (unstimulated pain) was also applied. A spectrophotometer was used to measure the color.~     Three bleaching sessions were performed, with intervals of 7 days. Sensitivity results were~     tested using Friedman test for intra-group evaluation and Wilcoxon test for inter-group~     evaluation and ANOVA for color change.~   "
4019|NCT03514277|"~     The purpose of this study is to collect information about how patients feel when doctors~     manage their pain after lumbar spine surgery using a combination of EXPAREL® and bupivacaine~     injected into the lumbar spine at the end of surgery, compared to the patients that doctors~     use only EXPAREL® or bupivacaine to manage their pain. This information will help doctors~     determine which approach works best for patients who will receive surgery in their lumbar~     spine in the future.~   "
4020|NCT03514264|"~     A randomized, interventional, prospective, unicentric clinical study, 86 patients will be~     submitted to endodontic treatment of necrotic teeth. 43 patients will complete treatment with~     obturation with AHPlus cement and Gutta-Percha cones (group A) and 43 patients will complete~     treatment with PBS® CIMMO cement (single material) (group B). The primary outcome will be the~     repair of the periradicular lesion demonstrated by integrity of the hard blade throughout the~     perimeter of the root identified by Tomography Cone Beam, performed after 6 months of~     treatment. The secondary endpoint will be the absence of fistula after 6 months of treatment~     identified by clinical examination.~   "
4021|NCT03514251|"~     To study the protective effect of suture parathyroid marker method on the function of~     parathyroid gland in thyroid cancer surgery~   "
4022|NCT03514238|"~     It has been established that greater amounts of vigorous intensity physical activity lead to~     improved health outcomes. Interestingly, the response of biologically active substances,~     called myokines, differs according to exercise intensity. As such, the current study aims to~     compare the difference in the response to irisin according to different exercise intensities~     in both normal weight subjects and individuals living with obesity. This study will compare~     continuous moderate intensity physical activity to high intensity physical activity against a~     control condition. Furthermore, this study will determine whether differences in exercise~     intensity are associated with better insulin sensitivity.~   "
4023|NCT03514225|"~     Social anxiety disorder (SAD) is a fear of social situations that involve interacting with~     other people. Although it can be very upsetting, there are ways to help people deal with it.~     This study aims to explore the use of a new treatment called Metacognitive Therapy (MCT) for~     social anxiety in children and teenagers. MCT is a one-to-one talking therapy which works by~     changing people's patterns of attention and thinking in social situations. By doing this,~     people with SAD can begin to feel more confident and less anxious when interacting with~     others.~      Findings suggests that MCT works well when treating adults who have social anxiety. However,~     this treatment has not yet been used with young people. This study hopes to explore whether~     MCT can help treat SAD in children and teenagers. This information will help us to plan~     larger studies in the future.~      People who would like to take part in this study will be asked to fill in some questionnaires~     once a week for at least 2 weeks and return these to the researcher in the post. Following~     this, they will be offered 8 weekly sessions of MCT at their local Child and Adolescent~     Mental Health Service. Each session will last for about 1 hour. This will involve talking to~     a clinician about how they think and feel when in social situations, and filling in some more~     questionnaires. This will allow us to see how their social anxiety changes week-by-week and~     whether this has improved by the end of treatment (week 8).~      3-months after people have had their last session of MCT, they will be asked to complete and~     return a final set of questionnaires through the post. This will allow us to get a final~     measure of their social anxiety and see whether any changes in SAD have been maintained.~      Primary Questions:~        -  Is MCT a feasible and acceptable treatment for social anxiety disorder within a child~          and adolescent population?~        -  Is MCT associated with improvements in SAD symptoms and functioning?~      Secondary Questions:~        -  Are benefits associated with MCT replicable across subtypes of social anxiety disorder~          (general and specific)?~        -  Are any gains associated with MCT for social anxiety disorder maintained at 3 month~          follow up?~   "
4042|NCT03513978|"~     The prevention of injuries has a close relation with the proprioception. In this sense, the~     proprioception is defined as the information about the corporal and segmental movement, as~     well as the position of the body and the corporal segments of oneself in the space. Some~     authors divide the proprioception into kinesthesia and the Joint Position Sense (JPS).~      The hypothesis of the study is the implantation of a progressive multimodal exercise protocol~     with transferences to sport in the trainings of amateur male soccer players in the age range~     from 18 to 30 years, can decrease the adverse effects of the fatigue during the high~     intensity activities and its relation with the JPS. Due to the close relation between fatigue~     and incidence of injuries, the obtaining of positive results could be an important finding~     for the design of prevention and rehabilitation protocols in soccer.~   "
15124|NCT03368937|"~     A 36-48 hour admission testing the t:slim X2 with Control-IQ Technology~   "
4024|NCT03514212|"~     People with schizophrenia die approximately 20 years earlier than those in the general~     population, and this is mostly due to cardiovascular disease (CVD) and related poor physical~     health. The risk factors for CVD are significantly more prevalent in people with~     schizophrenia, but they are largely preventable by, for example, engaging in regular PA.~     Existing interventions to increase PA in schizophrenia are generally atheoretical and lack~     manualisation and appropriate evaluation, thus reducing their usefulness to clinical~     practice.~      Drawing on the MRC Guidelines for the development and evaluation of complex interventions, a~     12-week intervention was developed and informed by a systematic review of the factors that~     influence PA in people with schizophrenia and a qualitative study exploring the barriers and~     motivators to PA (n=10). The feasibility and acceptability of the intervention was then~     investigated in an uncontrolled pilot study (n=20).~      The pilot study demonstrated that the intervention was both feasible and acceptable to people~     with schizophrenia. The retention rate was 90% (n=18), and reasons given for dropout were~     work commitments and other illness.~      Of the 18 who completed the intervention, 17 (94%) increased their weekly step count, 14~     (78%) met current public health guidelines of 10,000 steps per day at some point during the~     12 weeks, 10 (56%) experienced some weight loss, 12 (67%) took up an additional health~     promotion opportunity (e.g., improving diet, stopping smoking, joining a gym) and 13 (72%)~     took up another form of PA in addition to walking (e.g., swimming).~      Participants found the intervention enjoyable and thought it should be offered to everyone~     with schizophrenia. The intervention also proved to be feasible and acceptable to staff who~     referred patients to take part. Informal feedback from staff confirmed the need for such a~     service, particularly for those taking anti-psychotic medication, and indicated that, if it~     was to be implemented more widely, it would be a popular and useful resource.~   "
4025|NCT03514199|"~     The majority of the elderly present with sleep apnea and mortality is significantly higher in~     this group. Sleep apnea runs the risk of developing diseases, especially hypertension and~     cardiovascular disease, while the Mediterranean diet is associated with reduced risk.~      No study evaluated the effect of the Mediterranean diet on the apnea and hypopnea index in~     the elderly. Therefore, the present work intends to evaluate the effect of the intervention~     with the Mediterranean diet on the apnea-hypopnea index in the elderly with moderate sleep~     apnea.~      The hypothesis study is that the elderly with moderately severe sleep apnea under a~     Mediterranean-type diet will modify AHI in the short term, regardless of weight change, due~     to changes in body volume and ingestion, especially those related to body water.~   "
4026|NCT03514186|"~     The purpose of this study is to conduct a randomized clinical trial that assesses the~     efficacy and cost-effectiveness of an Intensive Comprehensive Aphasia Program (ICAP),~     specifically focusing on the variable of intensity. Half of the participants will receive 60~     hours of intensive treatment over three weeks, while the other half will receive the same~     amount and type of comprehensive treatment distributed over 15 weeks.~   "
4027|NCT03514173|"~     The subject of the observation study with accompanying employee survey is the evaluation of a~     patient remote monitoring system (Vital Sync from Medtronic, hereinafter abbreviated as~     Vital Sync) in intensive care medicine.~      The aim of this research project is to determine whether the use of Vital Sync on an~     intensive care unit is accepted by medical and nursing staff and can be integrated into~     everyday work as an additional visualisation and analysis tool.~   "
4028|NCT03514160|"~     Frailty in older adults is a consequence of physical inactivity, which leads to poor physical~     function, disability and poor health outcomes. Nearly 60% of older adults report inactivity.~     Emotion regulation strategies have affective, cognitive and social consequences. Positive~     emotions are significantly associated with a higher ability to perform activities of daily~     living. There is a gap in the understanding of how exercise influences the selection of~     emotion regulation strategies (avoidant vs. adaptive) in frail older adults. The~     investigators propose to examine the interactions between regular exercise, selection of~     emotional regulation strategies, and daily physical activity in frail sedentary older adults.~   "
4029|NCT03514147|"~     Aim: To assess the influence of pelvic floor muscles group training in the quality of life~     and functionality of these muscles in women with UI.~      Study design: This is a randomized controlled trial.~   "
4030|NCT03514134|"~     The unemployment rate is quite high among adults with an autism spectrum disorder (ASD).~     Inadequate transition planning during high school and gaps between vocational needs and~     availability of evidence-based services help explain the struggles of transition-age youth at~     obtaining employment. There is a paucity of research on developing and evaluating services to~     support the transition to the work force after graduating from high school. The lack of~     available resources to support transition-age youth with an ASD speaks to the need to develop~     interventions that ameliorate obstacles to employment and help support the transition to the~     work force. Due to the social deficits characterizing ASD innovative interventions could~     target preparing job interview skills for students facing the transition to employment as the~     job interview is a critical gateway to securing a job offer. Thus, the overarching goal of~     this study is to modify an existing virtual reality job interview skills training program for~     use in high school students with ASD and to test the feasibility and effectiveness of~     conducting this intervention in a high school setting via a small controlled trial. Thus,~     study's first aim is to modify the existing 'Virtual Reality Job Interview Training' program~     to meet the specific needs of high school seniors with ASD. This will accomplish this by~     conducting in depth interviews with high school students with ASD and their vocational~     counselors to solicit feedback to modify the current training's learning goals, content,~     usability, and simulated interview scripts to meet the specific needs of transition age~     youth. An expert panel will determine the final modifications to the training program based~     on the results of the qualitative data analysis and their own views of the program. Second~     aim of the study is to conduct a pilot trial to evaluate the feasibility, acceptability,~     portability, fidelity and preliminary effectiveness of the modified intervention in a~     randomized controlled trial. This study will also explore potential mechanisms for~     effectiveness and collect pilot implementation data.~   "
4031|NCT03514121|"~     This is a multi-center study to evaluate the safety, tolerability, pharmacokinetics (PK), and~     pharmacodynamics (PD) of FPA150, an anti-B7H4 antibody in patients with advanced solid~     tumors. The Phase 1a, open-label, cohort will identify a recommended dose of FPA150 to use~     for Phase 1b.~   "
4032|NCT03514108|"~     The present study is testing in a combined design to types of drugs in patients with chronic~     heart failure: 1) Hydralazine in combination with isosorbide dinitrate (BiDil) and 2)~     Metformin hydrochloride. The study is double blind, placebo controlled.~        1. The first hypothesis is that hydralazine in combination with isosorbide dinitrate can~          reduce mortality and hospitalization with worsening heart failure.~        2. The second hypothesis is that treatment of underlying insulin resistance/ type 2~          diabetes with metformin in heart failure patients with moderately to severely reduced~          LVEF can reduce mortality and cardiovascular hospitalizations. Among secondary endpoints~          are reduction in new-onset diabetes in heart failure patients with insulin resistance~          and diabetes risk profile and patient safety.~   "
4043|NCT03513965|"~     People who are undergoing oral immunotherapy for food allergy treatment can feel anxious~     about the treatment process, particularly when they have allergic responses (e.g., hives,~     vomiting, nausea) during the dosing process. People may commonly believe that these symptoms~     are simply side effects that must be endured or avoided. However, the investigators propose~     that changing participants' mindsets about the meaning of symptoms—toward viewing them as a~     sign that the treatment is working and desensitization is increasing—during the treatment~     process will reduce anxiety and improve treatment outcomes.~   "
4033|NCT03514095|"~     Cognitive Stimulation (CS) in the elderly, as a group intervention, shows benefits on the~     cognition and quality of life of people with neurocognitive disorder (NCD)(ie, dementia). The~     evidence of cognitive stimulation as an individualized intervention, conducted at home, by~     the caregiver is limited. The main objective of this trial is to evaluate the effectiveness~     of the Individual Cognitive Stimulation Therapy program - Making a Difference 3 - individual~     Cognitive Stimulation Therapy (MD3), its acceptability and applicability by the dyad (people~     with NCD and their caregiver) in the Portuguese population. To achieve this purpose a pilot~     study will be conducted (randomized control trial), with two moments of evaluation - before~     the intervention of individual cognitive stimulation and after the intervention in both~     groups (Group 1 - group subject to intervention: individual cognitive stimulation program~     called MD3; Group 2 - group subject to usual care).The investigators intend to know the~     effect of the program on cognitive domains, quality of life and relationship between~     caregiver and care recipient. And, as well as understand the acceptability and applicability~     of the program by participants (dyad).~   "
4034|NCT03514082|"~     Adolescent Idiopathic Scoliosis (AIS) is a rotational deformity of the spine that could be~     seen 2-3% of population. Conservative treatment of AIS with 20-45 degree lateral flexion~     angle (Cobb) includes brace and therapeutic exercises. Some gait abnormalities were defined~     like decreased torsional movements of spine, increased muscular work and energy expenditure~     in AIS. Additionally wearing a brace limits pelvic motions and affects pendulum-like~     mechanism of gait. Our aim was to investigate gait energy consumption, pulmonary functions,~     balance and lower extremity loading symmetry in AIS subjects who are getting conservative~     treatment.~   "
4035|NCT03514069|"~     The purpose of this study is to test how well the drug works, safety and tolerability of an~     investigational drug called Ruxolitinib in gliomas and glioblastomas, when combined with~     standard treatment for brain cancer, temozolomide and radiation.~      Ruxolitinib is an experimental drug that works by targeting proteins in cells and stops them~     from growing. Ruxolitinib is experimental because it is not approved by the Food and Drug~     Administration (FDA) for the treatment of gliomas or glioblastomas~      Temozolomide works by damaging the DNA of tumor cells so that they cannot divide properly.~     Some tumor cells can repair that damage and therefore be resistant to temozolomide.~   "
4036|NCT03514056|"~     In various studies, the incidence of fibromyalgia in Behçet's patients is widely distributed.~     It was aimed to investigate the frequency and severity of fibromyalgia in Behcet disease in~     province Bursa.~   "
4037|NCT03514043|"~     Emergency ambulatory care (day-case care that does not involve staying in a hospital bed~     overnight) is now well-established for medical patients and is being used increasingly for~     surgical patients. However, it is not known how emergency surgical patients feel about being~     managed in this way compared to being admitted to a hospital ward. The investigating team~     believe that some people will find it easier and would prefer to be able to stay at home~     overnight but others may find this difficult or dislike this method of care.~      The investigators want to explore patients' experience of this type of care with~     semi-structured telephone interviews. The interviews will take around 20-30mins each and the~     anticipated number of participants needed is 20.~   "
4038|NCT03514030|"~     In 1894, Devic first proposed the concept of neuromyelitis optica(NMO). NMO is an~     inflammatory demyelinating disease that selectively affects the central nervous system of the~     optic nerve and spinal cord.In 2004, Lennon and other persons found highly specific~     AQP4（aquaporin 4）antibodies in NMO patients'sera, and further differentiated between NMO and~     MS, confirming that NMO is an independent disease.At present, NMO has been widely recognized~     as an idiopathic and severe demyelinating disease of the central nervous system.In 2015, the~     international NMO diagnostic team developed the diagnostic criteria based on highly specific~     AQP4 antibodie.Up to now, in China, there is no data on the number of NMOSD patients, the~     rate of misdiagnosis, the treatment methods, and the prognosis.This study is committed to~     build China's NMOSD big data platform to provide the basis for diagnosis, treatment and~     prognosis of the disease.~   "
4039|NCT03514017|"~     The purpose of this study is to evaluate the impact of sequential overlapping treatment with~     PD-1 monoclonal antibody (mAb), pembrolizumab/MK-1375, followed by ibrutinib on endogenous~     immune function in previously untreated, high-risk CLL patients. Immune function will be~     evaluated through various laboratory correlative tests.~   "
4040|NCT03514004|"~     A cluster randomized controlled trial (RCT) of a program based on information and~     communication technologies (ICT) will be conducted to prevent suicide and strengthen mental~     health among secondary school students in Chile. The program utilizes a web-based platform~     and a mobile application to cultivate a virtual community to promote mental health protective~     factors, such as self-esteem and self-expression, and reduce suicide risk. It is based on the~     principles of peer-support and inclusivity, and it has been inspired by previous studies in~     Europe and the US. The trial will take place in six public secondary schools in two cities of~     Chile: Santiago and Rancagua. Schools will be randomly assigned to either intervention or~     control conditions. Assessment will be conducted at baseline, 3-month (post intervention),~     and at 5-months (2 month follow-up).~   "
4041|NCT03513991|"~     Human milk (HM) is the gold standard of early infant nutrition. The World Health Organization~     (WHO) recommend that newborns be exclusively breastfed for the first 6 months of life. It has~     beed reported that an exclusive breast feeding at 6 months of age range from 10 to 46%. Thus,~     the intake of infant formulas (IF) is quite widespread, including infants that have less than~     6 months that are not receiving breast milk. Most of the commercial IF are cow's milk-based~     formulas that have a higher concentration of protein than breast milk and have a different~     protein composition. Commercial IF have a low proportion of alpha lactoalbumin, and A1~     β-casein; during its digestion, a β-casomorphin 7 peptide is produced. In addition, it has a~     high concentration of β-lactoglobulin. Both, β-casomorphin 7 and β-lactoglobulin have been~     associated with a higher risk of diabetes obesity and allergies. Human β-casein does not~     produce β-casomorphin 7 during its digestion, it has a high concentration of~     alpha-lactoalbumin and does not have β-lactoglobulin.~      The purpose of this study is to evaluate growth, gastrointestinal tolerance, and~     β-casomorphin 7 in urine of infants that are exclusively breastfed compared to infants fed~     three IF with different proteint content.~   "
10142|NCT03434054|"~     This experimental medicine study explores whether a single dose of losartan (50mg) versus~     placebo affects the processing of positive and negative stimuli, using fMRI.~   "
4044|NCT03513952|"~     This phase II trial studies how well atezolizumab when given with glycosylated recombinant~     human interleukin-7 (CYT107) works in treating participants with urothelial carcinoma that~     has spread to nearby tissue or lymph nodes, cannot be removed by surgery, or has spread to~     other places in the body. Monoclonal antibodies, such as atezolizumab, may interfere with the~     ability of tumor cells to grow and spread. CYT107 is a biological product naturally made by~     the body that may stimulate the immune system to destroy tumor cells. Giving atezolizumab and~     CYT107 may work better in treating participants with locally advanced, inoperable, or~     metastatic urothelial carcinoma.~   "
4045|NCT03513939|"~     The Cell Pouch™ is a novel implantable device, that is transplanted with therapeutic cells~     such as insulin producing islets. This combination product is designed for the treatment of~     Type 1 Diabetes Mellitus (T1DM) with hypoglycemia unawareness and a history of severe~     hypoglycemic episodes. Upon implantation, the Cell Pouch™ is designed to form a natural~     environment, rich in tissue and microvessels for the transplant and function of therapeutic~     cells. The Cell Pouch™ is designed as a scaffold made of non-degradable polymers, formed into~     small cylindrical chambers which, when placed in the subcutaneous site, becomes incorporated~     with tissue and microvessels to the circumference of removable plugs within as early as two~     weeks as demonstrated in preclinical studies. After the tissue incorporation, the plugs are~     removed, leaving fully formed tissue chambers with central void spaces for the~     transplantation of therapeutic cells including Islets of Langerhans (islets). The Cell Pouch™~     forms a natural environment, rich in microvessels that allows the transplanted islets to~     engraft with intravascular microvessels. It is believed this engraftment will enable~     long-term survival and function of transplanted islets. This study aims to demonstrate the~     safety and tolerability of islet transplantation into the Cell Pouch™ for the treatment of~     T1DM in subjects with hypoglycemia unawareness and a history of severe hypoglycemic episodes.~     The study also aims to establish islet release criteria that accurately characterize the~     islet product and are predictive of clinical transplant outcomes into the Cell Pouch™, which~     will be demonstrated through defined efficacy measures.~   "
4046|NCT03513926|"~     Evaluation of anthropometric, clinical and biological profile in four groups that represents~     transversely the natural history of Obstructive Sleep Apnea (OSA) and its associated~     cardiovascular comorbidities: non-OSA, OSA without hypertension, OSA and with hypertension~     and OSA with a cardiovascular event (CVE).~   "
4047|NCT03513913|"~     In this prospective randomized clinical trial we plan to compare two fertilization method~     which are widely used during in vitro fertilization (IVF) treatment. Outcome of conventional~     IVF and intracytoplasmic sperm injection (ICSI) treatment will be compared in this study.~   "
4048|NCT03513900|"~     Portal hypertensive gastropathy (PHG) is used to describe the endoscopic appearance of~     gastric mucosa in patients with cirrhotic portal hypertension, with a characteristic~     mosaic-like pattern with or without red spots. The severity of PHG can vary from mild to~     severe, and patients with PHG are at an increased risk of acute and chronic gastrointestinal~     bleeding. According to the study by Kim et al, severe PHG showed a significantly high risk of~     mortality and reduced expected survival time than none or mild PHG. Therefore, we need to~     detect PHG as soon as possible.Upper gastrointestinal endoscopy is the gold standard test for~     measuring PHG, however, an invasive tool, and patients are afraid of it. Therefore, there is~     a need to find effective noninvasive indicators of PHG that can be predicted in the early~     stages, especially which requiring intervention.~   "
4049|NCT03513887|"~     Liver cirrhosis is caused by chronic liver diseases, varices exist in 30 - 60% of patients~     with liver cirrhosis. Variceal bleeding is one of the most important complications of~     cirrhosis, accelerating the progression of decompensation to a stage at which the patient is~     at an extremely high risk of death. Endoscopy is the gold standard for the diagnosis of~     varices, However, periodic endoscopic screening in all cirrhotic patients might unnecessarily~     induce an invasive and expensive procedure, ultimately increasing not only the medical~     workload of endoscopy units, but also the financial burden of patients. To avoid unnecessary~     endoscopy in low- risk patients, some simple, non-invasive and accurate tests have been~     developed to identify EVs. Such as Transient elastography (TE) , which is a noninvasive tool~     that measures liver stiffness (LS) correlating to liver fibrosis stage. Moreover, the~     LS-spleen size-to-platelet ratio score (LSPS), which is a combination of three simple~     examination methods (LS, spleen size and platelet count) has been established to accurately~     predict EVs in patients with cirrhosis. Therefore, we design this cross-sectional study to~     assess these non-invasive tests in predicting the presence of EVs in patients with cirrhosis.~   "
4050|NCT03513874|"~     The objective of this study is to evaluate the therapeutic effect of metformin as additional~     treatment with insulin on non-obese autoimmune diabetes.~   "
4051|NCT03513861|"~     The purpose of this pilot study is to improve inpatient monitoring of severely-ill children~     admitted to the hospital in low resource settings at Kenyatta National Hospital in Nairobi,~     Kenya. Given the high ratio of patients to medical staff in these settings, the lack of~     reliable patient monitoring tools, and the high rate of early inpatient mortality, we will~     prospectively train parents as monitoring aids of their hospitalized children. Early~     recognition and intervention in critical illness is important to avoid (further) organ~     failure. Parents will be taught how to assess their child's mental status, work of breathing~     and capillary refill time which will inform a 3-point severity of illness scale. The severity~     of illness will be conveyed by the parents to the medical staff via color-coded flag system.~     The goal is to increase the healthcare provider patient reassessment rate according to~     patients' level of severity to assist in early recognition and treatment of patients'~     deterioration.~   "
4052|NCT03513848|"~     There is evidence that some of the circadian photoreceptors, the intrinsically photosensitive~     retinal ganglion cells (ipRGCs), project directly to the amygdala, an area of the brain~     implicated in PTSD. Thus, a self-administered morning light treatment at home (shifts clock~     earlier and stimulates ipRGCs) may be a potentially efficacious adjunctive strategy for~     reducing PTSD symptoms. This study will test a 4 week daily 1 hour morning light treatment~     (active vs placebo) in individuals with PTSD. Outcome measures include measures of PTSD and~     depression.~   "
4394|NCT03509389|"~     Observational prospective study to evaluate the feasibility, effectiveness and the rate of~     complications of the XLIF (Extreme Lateral Interbody Fusion) performed in prone position to~     treat spinal diseases of the lumbar region.~   "
4053|NCT03513835|"~     The purpose of this study is to develop simple diagnostic screeningtests and investigate~     potential biomarkers for identifying patients with abnormalities of mitochondrial function,~     which also can be used as outcome measures in future clinical trials. The study will~     investigate two submaximal tests: a submaximal handgrip test and a walking test. Furthermore~     investigators will investigate Acyl-carnitine profiles and GDF-15 levels in patients with~     mitochondrial myopathy.~   "
4054|NCT03513822|"~     The kynurenine pathway is involved in hyperalgesia. This pathway is activated by~     inflammation. Ketamine would interact with the kynurenine pathway and inflammation. Our~     working hypotheses are: the clinical effects of ketamine on neuropathic pain are greater in~     the presence of systemic inflammation and the mechanism of action involves an interaction on~     the kynurenine pathway.~      Study design: Interventional randomized placebo-controlled clinical trial.~      ￼Main goals:~        1. To show a better clinical efficacy of ketamine in chronic pain in patients with an~          inflammatory component.~        2. Explore the anti-inflammatory activity of ketamine through the Kynurenine pathway.~   "
4055|NCT03513809|"~     Spontaneous breathing efforts in patients with respiratory failure connected to mechanical~     ventilation, has been associated with strong respiratory muscles activity. However, these~     mechanisms may will be present in patients with acute lung deseases who are breathing with no~     ventilatory support.~      We hypothesize that spontaneous breathing during acute respiratory failure could induced lung~     inflammation and worsen lung damage. Hereby, the connection to a ventilatory support tool,~     may protect the lungs from spontaneous ventilation-induced lung injury.~      To test our hypothesis, our aim is to determine the effects of spontaneous breathing in acute~     respiratory failure patients, on lung injury distribution; and to determine whether early~     controlled mechanical ventilation can avoid these deleterious effects by improving air~     distribution.~   "
4056|NCT03513796|"~     EVERYONES HCV is a retrospective review of all previous Hepatitis C (HCV) testing and~     diagnosis in NHS Tayside. The aim of this study is to analyse and compare the different~     Hepatitis C diagnostic pathways with a view to determining the most cost effective~     combination of methods of diagnosing HCV infection in a typical developed world population.~   "
4057|NCT03513783|"~     Patients with C5 or C6 tetraplegia have paralysis of the triceps brachii. Elbow extension can~     be surgically restored by transferring the tendon from a preserved muscle onto the tendon of~     the paralyzed triceps brachii.~      The most frequently used method transfers the posterior deltoid tendon. However, transferring~     the posterior deltoid can create an imbalance in the shoulder joint and this technique is not~     recommended when the clavicular head of the pectoralis major is weak.~      In such cases, a preferred method is a biceps brachii tendon transfer. The success of this~     intervention relies on the ability of the patient to dissociate the drive between the~     transferred biceps brachii and the other elbow flexor muscles.~      Even though tendon transfers are widely used, the subsequent reorganization of muscle~     coordination strategies remains largely unknown. The identification of muscle synergies and~     co-coactivations from electromyography (EMG) signals, defined as groups of muscles activated~     in synchrony, may help to provide a deeper understanding of changes in muscle coordination.~     The objective of this study is to investigate for the first time the reorganization of muscle~     coordination after surgical restoration of elbow extension through the identification of~     muscle synergies and the quantification of muscle co-activations.~      Four participants with tetraplegia will take part to this study. The experimental procedure~     will be conducted before their surgery and once a month during 6 months after their surgery.~      The procedure consists of performing consecutive elbow extension-flexion cycles with the~     shoulder abducted at different angles. Surface and intramuscular EMG measurements will be~     collected for several upper limb muscles. Muscle synergies and co-activations will be~     extracted from the EMG measurements.~   "
4058|NCT03513770|"~     This research is being done to determine how the blood pressure control is altered by an~     increased volume in the veins.~   "
4059|NCT03513757|"~     The purpose of this study is to compare the results of combining two anesthetic medications~     (dexmedetomidine and propofol) in low doses with a standard dose of a single drug that is~     commonly used to provide sedation/anesthesia for MRI studies in young children (propofol).~      The drugs used for the MRI scan in this study will be chosen randomly. Half the patients will~     receive small doses of propofol and dexmedetomidine. The other half will receive propofol~     administered constantly throughout the scan. Other drugs that may be used include sevoflurane~     and nitrous oxide at the start of the sedation (for placing an intravenous), lidocaine (to~     reduce the pain of propofol injection) and glycopyrrolate (to prevent the heart rate from~     decreasing too low. The investigators will record 5 additional blood pressures and heart~     rates. If additional medications are required to complete the scan, the investigators will~     administer whatever is necessary. At the end of the study, the investigators will have an~     observer record the time it takes for participants to spontaneously open eyes , to be able to~     drink liquids and/or eat and to behave as before the study. Also, it is very important that~     the investigators find out from participants about changes in behavior, or if eating or~     sleeping habits were unusual following completion of the study. For that reason, the~     investigators will call participants in a day or so following the MRI scan.~      The investigators expect to recruit 70 children between the ages of 12 and 72 months for the~     study and hope to have the study completed in December 2018.~   "
4060|NCT03513744|"~     The primary objective of this clinical study is to investigate the suitability of an infant~     formula containing five different human milk oligosaccharides to support normal physical~     growth (evaluated per weight gain), in comparison with infant formula without human milk~     oligosaccharides, when the formula is fed as the sole source of nutrition.~   "
4061|NCT03513731|"~     This is a prospective, randomized, active controlled, single site safety and efficacy study~     in subjects suffering from chronic lumber back pain due to facet joint osteoarthritis~     comparing a single ADRC injection generated with the Transpose® RT system into the facet~     joint.~   "
4062|NCT03513718|"~     The purpose of this retrospective study is to determine the incidence and severity of acute~     kidney injuries (AKI) after heart surgery on cardiopulmonary bypass (CPB) in the pediatric~     intensive care unit (PICU) in Lausanne, Switzerland.~   "
4063|NCT03513705|"~     PACAP-1 will evaluate to what extent an enhanced implementation of best practices in~     pancreatic cancer care leads to a prolonged survival and improvement of quality of life as~     compared to current practice.~   "
4065|NCT03513679|"~     The purpose of this study is to evaluate the effect of cervical decompression surgery on the~     biomechanics of the lower extremities and spine during balance and gait in patients with~     cervical spondylotic myelopathy (CSM), before and after surgical intervention, and compare~     these parameters to an asymptomatic control group. To test our hypothesis that cervical~     decompression will improve preexisting gait disturbance, a gait analysis using dynamic~     surface EMG, video motion capture, and force plate analysis will be used. Patients 30 to 70~     years old will be eligible for the study. Thirty subjects diagnosed with symptomatic CSM and~     are deemed appropriate surgical candidates, along with 30 healthy subjects with no spine~     pathology, will be enrolled in this study. Exclusion criteria include any history of previous~     lumbar/thoracic surgery or lower extremity surgery, BMI greater than 35, or currently~     pregnant. Each subject from the surgical group will be evaluated on 3 different occasions: 1)~     1 week before surgery, 2) 3 months postoperative, and 3) 12 months postoperative. Control~     subject will only be evaluated once. Bilateral trunk and lower extremity neuromuscular~     activity will be measured during a full gait cycle using dynamic surface EMG measurements.~     Human video motion capture cameras will collect lumbar spine and lower and upper extremity~     joint angles. Ground reaction forces (GRFs) will be collected from a 5 foot stretch of force~     platforms in order to define a full gait cycle.~   "
4066|NCT03513666|"~     JS001 combined with pemetrexed plus carboplatin for treatment of recurrent or advanced~     non-small-cell lung cancer with EGFR-mutation positive and T790M negative after progression~     on EGFR-TKI treatment：a multi-center, single arm phase II study~   "
4067|NCT03513653|"~     STRATS-AHF (STrain for Risk Assessment and Therapeutic Strategies in patients with Acute~     Heart Failure) registry enrolled 4,312 patients hospitalized for acute HF from 3 tertiary~     university hospitals (Seoul National University Bundang Hospital, Seoul National University~     Hospital, and Chungnam National University Hospital) from January 2009 through December 2016.~   "
4068|NCT03513640|"~     Although the pathophysiology of meconium obstruction of prematurity (MOP) is not clear, it is~     known that the decrease of the intestinal peristalsis due to decreased intestinal perfusion~     during antenatal or perinatal period. Recently, the level of citrulline has been used as an~     index of function and injury of the small intestine State. This study aimed to evaluate~     citrulline level of cord blood as a marker for early detection and observe changes in~     intestinal blood flow in MOP patient.~      And We aimed to confirm the efficacy of the AT/ET ratio (ratio of the pulmonary artery~     time-to-peak velocity interval to the right ventricular ejection time) of the prenatal~     pulmonary artery as a noninvasive predictor of neonatal respiratory distress syndrome.~   "
4069|NCT03513627|"~     Apply LSCI method for follow-up changes in regional blood flow after compression of the~     gingiva in order to compare the vascular reactivity of the attached gingiva at implant versus~     at tooth.~   "
4070|NCT03513614|"~     RATIONALE: The use of tailored axillary dissection as a tailored procedure will avoid~     surgical overtreatment by selectively removing the lymph nodes that are affected by the~     cancer, thereby sparing many women the unnecessary complications of a radical surgery,~     providing a better quality of life while keeping the same efficacy.~      PURPOSE: The phase III trial is evaluating the optimal treatment for breast cancer patients~     in terms of surgery and radiotherapy.~   "
4071|NCT03513601|"~     To explore the clinical features and efficacy evaluation of large b-cell lymphoma in old age.~   "
4072|NCT03513588|"~     2-week study in people with nonalcoholic fatty liver disease. Study drug at 1 of 2 doses, or~     placebo, will be given for 14 days. Blood samples, heart monitoring, vital signs, and imaging~     procedures will be performed.~   "
4073|NCT03513575|"~     The diurnal variation in the flow of saliva and hence the composition of saliva is an~     established fact. Consumption of most types of acidic and sweetened foods and beverages are~     known to reduce the pH of saliva and some of them even reduce it to critical pH levels and~     result in structural damage to the hard tissues of the tooth.~      The purpose of this study is to ascertain the effect of the selected commercially available~     test sweetened flavored milk drink on the salivary pH and assess the buffering capacity of~     the saliva with or without various intervention measures following the exposure to the test~     flavored milk drink at different time intervals.~   "
4074|NCT03513562|"~     This phase II trial studies how well venetoclax and ibrutinib work in treating participants~     with chronic lymphocytic leukemia and have developed genetic mutations after previously being~     treated with ibrutinib. Venetoclax and ibrutinib may stop the growth of cancer cells by~     blocking some of the enzymes needed for cell growth.~   "
4075|NCT03513549|"~     This postmarketing observational study will evaluate the safety of ADASUVE® in treating~     patients with agitation associated with schizophrenia or bipolar I disorder.~   "
4076|NCT03513536|"~     This study evaluates the effects of essential oils on nausea, vomiting, and quality of life~     scores among pregnant women. Participants will receive either an essential oil roll-on~     product or a placebo product to apply to their temples and jaw line daily for 6 days.~   "
4077|NCT03513523|"~     The purpose of this study is to determine if there is a relationship between daily~     consumption of NRPT, over a six-month (26-week) period, and changes in liver fat~     accumulation, compared to placebo and change from Baseline in healthy volunteers. In~     addition, an exploratory assessment of markers of inflammation and liver fat metabolism will~     be examined.~   "
4078|NCT03513510|"~     The primary aims were to assess community capacity to develop, implement, and sustain a~     childhood obesity reduction initiative in the health-disparate Dan River Region as well as to~     pilot test iChoose to determine the potential reach (i.e., proportion of target population &~     representativeness), effectiveness (i.e., changes in child BMI z-scores over a 6 month~     period), feasibility (i.e., the degree to which the intervention can be adopted, implemented,~     and sustained as intended) and cost (i.e., resource and staffing costs) of the newly~     developed intervention.~   "
4175|NCT03512249|"~     This is a phase 2, double-blind, randomized (1:1), placebo-controlled trial with two parallel~     groups.~        -  H56:IC31 (investigational vaccine)~        -  Placebo~           900 HIV-negative adults with a diagnosis of drug susceptible pulmonary TB are planned to~          be included, recruited from TB clinics with established relationships to the trial sites~          at the start of their TB treatment.~           4 trial sites are planned in South Africa (ZA): 1 site in Klerksdorp at the Aurum~          Institute and 3 sites in Cape Town at TASK, UCT Lung Institute and SATVI. 1 trial site~          is planned in Tanzania (TZ): 1 site in Mbeya at NIMR.~   "
4079|NCT03513497|"~     To characterize the expression of IFI16 and AIM2 in gingival tissues in an inflammatory~     response using an acrylic mouthguard (also referred to as a stent) induced bacteria~     overgrowth method.~      Participants: A maximum of 72 Adult subjects will be recruited from the patients, students~     and staff at the University of North Carolina, as well as the general population in or near~     Chapel Hill NC.~      Procedures (methods):~      Medical history, demographics, (height/weight), urine based pregnancy test, vital signs (to~     include blood pressures, and pulse) standard dental clinical measures (to include plaque~     index, gingival index, bleeding on probing, and clinical attachment level), alginate~     impressions taken for fabrication of an acrylic stent (mouthguard), 2 gingival biopsies, 2~     subgingival (below the gumline) plaque samples, and Scaling Root planing (SRP)/or adult~     prophylaxis~   "
4080|NCT03513484|"~     The purpose of this study is to find the appropriate dose of the study drug nintedanib when~     combined with azacitidine and the associated side effects of the combination in older adults~     with AML characterized by HOX gene overexpression who are not interested in or not considered~     fit for standard intensive chemotherapy. The use of the study drug nintedanib in this study~     is investigational. Investigational means that this medication has not yet been approved by~     the FDA to treat this type of cancer. Azacitidine received FDA Approval in 2004 for~     myelodysplastic syndrome (a blood cancer related to AML) and has a National Comprehensive~     Cancer Network (NCCN) guideline recommendation for treatment of older adults who are not~     candidates for or decline intensive remission induction therapy. We expect participation to~     continue in this study based on each participant's response to the drug, and ability to~     tolerate treatment. Participants may continue to receive study treatments for 6 cycles (one~     cycle is 28 days long). If the 6 cycles of treatment is completed, participants may be moved~     on to a maintenance phase of treatment. Treatment will continue until the participant's~     leukemia gets worse, or they experience serious side effects, have a break in treatment for~     more than 56 days or the study doctor feels it is best for study treatments to stop.~   "
4081|NCT03513471|"~     Purpose: The primary objective of this study is to examine the effectiveness of anakinra as a~     rescue treatment for allergic airway inflammation. Utilizing an inhaled allergen challenge~     model, the investigators will determine the effectiveness of a single 1 mg/kg dose of~     anakinra administered after inhaled allergen challenge for mitigating features of airway~     inflammation.~      Participants: 12 mild allergic asthmatics sensitized to Dermatophagoides farinae (D. farinae)~      Procedures (methods): Eligible subjects will participate in a double blind cross-over study.~     Following randomization to the placebo or anakinra treatment group, subjects will undergo~     inhalation of D. farinae, and their early and late phase asthmatic responses will be~     measured. Subjects will undergo induced sputum sampling, methacholine challenge, and~     mucociliary clearance measures. After completion of period 1, subjects will cross over to the~     alternate study arm.~   "
4082|NCT03513458|"~     Purpose: The primary objective of this study is to examine the effectiveness of anakinra as a~     rescue treatment for allergic airway inflammation. Utilizing an inhaled allergen challenge~     model, the investigators will determine the effectiveness of a single 1 mg/kg dose of~     anakinra administered after inhaled allergen challenge for mitigating features of airway~     inflammation.~      Participants: 25 mild allergic asthmatics sensitized to Dermatophagoides farinae (D. farinae)~     Procedures (methods): 12 eligible subjects of 25 volunteers will participate in a double~     blind cross-over study. Following randomization to the placebo or anakinra treatment group,~     subjects will undergo inhalation of D. farinae, and their early and late phase asthmatic~     responses will be measured. Subjects will undergo induced sputum sampling, methacholine~     challenge, and mucociliary clearance measures. After completion of period 1, subjects will~     cross over to the alternate study arm.~   "
4083|NCT03513445|"~     This is a randomized prospective study that will compare the use of narcotics in a control~     group of non-injected patients with a treatment arm of patients injected intra-operatively~     with a ropivacaine, morphine, and epinephrine cocktail. The investigators hypothesize that~     this treatment will reduce narcotic use in patients during their hospital stay, and possibly~     decrease the length of their stay in the hospital.The investigators also hope their pain will~     be decreased as displayed by their multi-daily Clinically Aligned Pain Assessment (CAPA)~     score.~   "
4084|NCT03513432|"~     Our aim is to assess the effects of moderate consumption of beer and non-alcoholic beer on~     gut microbiota and biochemical biomarkers in healthy adults.~   "
4085|NCT03513419|"~     We will evaluate whether a resilience training program which includes group and individual~     parent training will be effective in improving optimism and resiliency in parents of young~     children with autism spectrum disorders (ASD). By observing the level of parent optimism and~     resiliency before and after intervention, we will be able to determine whether the~     intervention is effective in improving parent resilience.~   "
4086|NCT03513406|"~     The purpose of this study is to learn if there is a difference in recovery time when using~     sugammadex versus neostigmine. The researchers also hope to add further knowledge and data to~     the safety of using sugammadex in burn patients who are hypermetabolic.~   "
4087|NCT03513393|"~     Epclusa® is a pan-genotypic, once-daily tablet for the treatment of chronic hepatitis C virus~     (HCV) infection containing the NS5B- polymerase inhibitor sofosbuvir (SOF, nucleotide~     analogue) 400 mg and the NS5A inhibitor velpatasvir (VEL) 100 mg.~      Velpatasvir has pH dependent absorption. At higher pH the solubility of velpatasvir~     decreases. It has been shown that in subjects treated with proton pump inhibitors (PPIs) such~     as omeprazole, the absorption of velpatasvir is reduced by 26-56%, depending on the dose of~     omeprazole, concomitant food intake, and timing/sequence of velpatasvir vs. omeprazole~     intake. As a result, concomitant intake of PPIs with velpatasvir is not recommended.~      For a number of reasons, the prohibition of PPI use with velpatasvir is a clinically relevant~     problem. First, PPI use is highly frequent in the HCV-infected subject population with~     prevalences reported up to 40%. Second, PPIs are available as over-the-counter medications~     and thus can be used by subjects without informing their physician. Third, although HCV~     therapy is generally well tolerated, gastro-intestinal symptoms such as abdominal pain and~     nausea are frequently reported, which my lead to PPI use.~      One solution of this problem could be the use of other acid-reducing agents such as~     H2-receptor antagonists or antacids. In general, they have a less pronounced effect on~     intragastric pH, and are considered less effective than PPIs by many patients and physicians.~      A second solution would be the choice of another HCV agent or combination that is not~     dependent on low gastric pH for its absorption such as daclatasvir. Daclatasvir, however, is~     not a pan-genotypic HCV agent and may be less effective against GT 2 and 3 infections than~     velpatasvir. Second, not all subjects have access to daclatasvir, depending on health~     insurance company or region where they live.~      A third solution, and the focus of this COPA study, is to add a glass of the acidic beverage~     cola at the time of velpatasvir administration in subjects concurrently treated with PPIs.~     This intervention has been shown to be effective for a number of drugs from other therapeutic~     classes who all have in common a reduced solubility (and thus reduced absorption) at higher~     intragastric pH, namely erlotinib, itraconazole, ketoconazole.~      The advantages of this approach are: (1) only a temporary decrease in gastric pH at the time~     of cola intake; the rest of the day the PPI will have its therapeutic effect (2) cola is~     available worldwide (3) the administration of cola can be done irrespective to the timing of~     PPI use.~   "
4088|NCT03513380|"~     The purpose of this project is to assess if playing a newly developed videogame that require~     physical activity (e.g. exergame) can lead to health benefits. The project will include 50~     adult participants that are not particularly physically active. They will be randomized into~     two groups where one group will be given free access to the exergame for 6 months. The~     physical fitness (maximal oxygen consumption), blood markers of cardiometabolic health and~     body composition of the subjects will be tested before, mid-ways and after the intervention~     period. Also, the participants gaming frequency will be registered throughout the 6-month~     period. Aim of this study is to investigate if access to this game can provide health~     benefits for individuals who are not motivated to take part in regular physical activity.~   "
4089|NCT03513367|"~     There isn't specific Health related quality of life measure for children with DMD in French.~     The aim of this study is to validate the French version of the Pediatric Quality of Life~     Inventory 3.0 Duchenne Muscular Dystrophy module with a multicentric study. The investigators~     will evaluate the following psychometric properties : convergent validity, internal validity,~     inter-rater reliability. The investigators would like to be able to use this scientific tool~     in future clinical trials.~   "
4090|NCT03513354|"~     Introduction: Neuromotor losses are those that most affect the functionality of the elderly~     person. One of the preventive measures is the habit of practicing exercises regularly.~     Objective: To evaluate the motor fitness and the quality of life of elders before and after~     intervention, performed on soil and aquatic environment. Methodology: This was a randomized~     controlled trial, with blind evaluator and total sample of 38 elders, divided into three~     groups: control (n=15), soil (n=15), swimming pool (n=8). The following research instruments~     were used: socio-demographic data and health conditions, International Physical Activity~     Questionnaire (IPAQ), Mini-Mental State Examination (MMSE), Motor Scale for the Elders (MSE)~     and Quality of Life Questionnaire Short Form-36 (SF-36). The elders were submitted to a~     physiotherapeutic program during six months. Data were analyzed by statistical software~     Statistical Package for Social Science (SPSS 20.0). Results: When comparing motor fitness~     averages after intervention by study group, the soil group had higher mean values for the~     fine motor (p=0.021), body scheme (p=0.006), space organization (p=0.011) and general motor~     fitness (p=0.004) than the control group. In the quality of life, when comparing intra-group~     means, both intervention groups had higher averages in the general health aspect domain~     (p=0.001 and p=0.005 for the soil and swimming pool groups, respectively). Conclusion: This~     study showed that the soil group presented significantly higher means than the control group~     after the intervention, and the intra-group quality of life improved in both the soil as the~     swimming pool.~   "
4091|NCT03513341|"~     This study explores the levels of daily physical activity and sedentary behaviour in~     Maastricht University's undergraduate first year students. Furthermore, this study explores~     the correlations between the students' demographical background information with their levels~     of physical activity and sedentary behaviour.~   "
4092|NCT03513328|"~     In this study, the investigators test 2 dose levels of thiotepa (5 mg/kg and 10 mg/kg) added~     to the backbone of targeted reduced dose IV busulfan, fludarabine and rabbit anti-thymocyte~     globulin (rATG) to determine the minimum effective dose required for reliable engraftment for~     subjects undergoing hematopoietic stem cell transplantation for non-malignant disease.~   "
4093|NCT03513315|"~     Investigators propose an intervention trial of a comprehensive education and treatment bundle~     designed to reduce morbidity and mortality associated with heat-related illness for low~     resource settings. Two set of interventions will be developed each for emergency department~     and for community/home. These interventions will be developed by an internal expert group and~     will be customized and implemented at the home and emergency department (ED) levels, will~     include evidence-based educational training guidelines for ED health providers as well as~     educational messages targeting home and community in Karachi, Pakistan.~   "
4094|NCT03513302|"~     The purpose of this study is to see if drinking beetroot juice (BRJ) is beneficial for aging~     patients. We hope to determine the effect of BRJ on exercise performance. BRJ improves~     exercise performance in athletes and normal people. We are trying to determine if BRJ~     improves exercise performance in aging patients. We will be comparing the effects of BRJ~     versus the effects of a placebo (BRJ without the nitrates that are naturally occurring in~     beets and other similar foods). It is thought that the benefits of BRJ may come from its~     natural nitrate content. Although BRJ is available for purchase in grocery stores, for the~     purposes of this study it is considered investigational, which means that it has not been~     approved as a medical therapy.~   "
4095|NCT03513289|"~     The primary purpose of this study is to better understand the impact of the Society of~     Critical Care Medicine (SCCM) THRIVE Collaboratives on patients, their families and~     clinicians.~      The investigators have formed an international and interprofessional evaluative team with~     experts in the field in an effort to explore interactions between survivors and THRIVE. This~     approach is reflective of the international ethos of SCCM and its collaboratives, with the~     potential to improve the generalizability of this survivorship research to different health~     systems.~   "
4096|NCT03513276|"~     Fast-track programs in Orthopaedic Surgery require early motion that can only be achieved by~     optimal pain management protocols. Multimodal analgesia protocols including local~     infiltration anesthesia (LIA) have obtained excellent results in fast-track programs~     involving Total Knee Arthroplasty but further research and data is needed in Total Hip~     Arthoplasty programs.~   "
4097|NCT03513263|"~     this will be an RCT. to determine if non-surgical treatment for periodontitis can improve the~     disease activity score in 28 joints of rheumatoid arthritis in an African setting. Rheumatoid~     arthritis patients with periodontal disease will be randomised into an immediate intervention~     arm and a delayed intervention arm and both groups will be followed for two three monthly~     periods~   "
4098|NCT03513250|"~     a prospective, randomized, placebo-controlled study will be conducted to investigate whether~     hyoscine-n-butylbromide has preventive effects on early postoperative CRBD in patients with~     urinary catheters who will undergo elective cesarean sections.~   "
4176|NCT03512236|"~     This is a single center, randomised, double-blind, active comparator controlled, three-period~     cross-over, single dose trial in subjects with type 1 diabetes mellitus.~   "
10590|NCT03428191|"~     The research about the target effect-site concentration of remifentanil, inhibiting stress~     reaction of the perineal prostate puncture when Dexmedetomidine being continuous pumping~   "
4099|NCT03513237|"~     Caesarean section is a common method of delivery in obstetrics. With the recent increase in~     the rate of this procedure, it is wise to understand and implement the optimal surgical~     technique. Therefore, different operational methods have been defined to reduce the risk of~     peri/post-operative morbidity.~      The digital dilatation of cervix during elective caesarean section has still been a concern~     when evaluating this issue. This procedure is supposed to help the drainage of blood and~     lochia postpartum, thus reducing infection or the risk of postpartum haemorrhage (PPH).~     However, on the contrary, this mechanical manipulation may also result in contamination by a~     vaginal micro-organism and increase the risk of infections or cervical trauma. Additionally,~     the effect of routine cervical dilatation on patients' perception of pain has not been~     studied sufficiently yet. As a result, the current literature lacks evidence of cervical~     dilatation on postoperative pain and is even not all in agreement regarding the potential~     benefits on overall maternal morbidity.~   "
4100|NCT03513224|"~     Medication non-adherence can lead to serious health issues for older adults. This study is a~     four week study in older adults using a new device, the eDosette, which dispenses and records~     how one takes their medications, and subsequently makes this information available to the~     primary care team by the internet. This study aims to show that the eDosette can report how~     well a group of older adults living independently in the community are taking their~     medications (e.g. medication adherence). This study hopes to show that the eDosette~     intervention could play a role in medication adherence by improving conversations between~     older adults and primary care.~   "
4101|NCT03513211|"~     Recent pre-clinical work has suggested that Itraconazole has an anti-cancer effect that works~     synergistically with hydroxychloroquine. This may delay the need for androgen deprivation~     therapy (ADT) and its associated toxicities in men with biochemically recurrent (BCR)~     prostate cancer. This study aims to determine feasibility, safety and efficacy of~     suba-itraconazole (SI) in combination with hydroxychloroquine (HQ) in the treatment of~     biochemically recurrent (BCR) prostate cancer as means of delaying time to commencement of~     androgen deprivation therapy.~   "
4102|NCT03513198|"~     Patients with non-resectable pancreatic cancer have a poor prognosis.The analysis of~     prognostic factors before treatment may be helpful in selecting appropriate candidates for~     chemotherapy and determining treatment strategies.~      The aim of the PEACE study is to assess the vascularity of pancreatic malignant tumors using~     contrast-enhanced endoscopic ultrasonography and to clarify the prognostic value of tumor~     vascularity in patients with locally advanced and metastatic pancreatic cancer.~   "
4103|NCT03513185|"~     About 70-80% of patients with somatic symptom disorder (SSD) visit the general medical~     hospital instead of psychiatric or other mental health settings. The current self-reporting~     questionnaires are neither sufficiently considering companioned anxiety or depression nor~     validated for monitor the treatment efficacy of such group. The Somatic Symptom Scale-China~     (SSS-Ch) is developed due to the urging clinical demanding in general hospital. The study~     aims to investigate whether the SSS-Ch could serve as a timely and practical instrument to~     detect SSD and assess the severity of the disorder.~   "
4104|NCT03513172|"~     In this study, investigators will be examining the intraocular pressure lowering effect of~     brimonidine 0.15% when administered 20min prior to intravitreal anti-VEGF injection.~   "
4105|NCT03513159|"~     The aim of the transsectorial care project TIGER is the reduction of readmission rates of~     geriatric patients. This aim shall be achieved by improving the hitherto inadequate care~     process for geriatric patients in the transition from hospital to home. The program offers~     substantial support of patients and their informal caregivers in the transition process from~     hospital to home via so called pathfinders, specialized nurses in geriatrics.The pathfinders~     effectively intertwine stationary and ambulatory care teams caring for a patient, thereby~     augmenting and complementing effective hospital release management.~   "
4106|NCT03513146|"~     The protective effect of mother's milk and colostrum on oropharyngeal cavity is not~     achievable with gavage feeding. This may be increase the risk of colonization of the~     oropharyngeal cavity with pathogenic bacteria and subsequent increase in the risk of neonatal~     sepsis. We aim to study the impact of Oropharyngeal Administration of Mother's Milk (OPAMM)~     before gavage feeding on clinical outcome, bacterial colonization of the GIT of preterm~     infants with pathogenic bacteria. We also aim to study the immune-protective effect of OPAMM~     on the incidence of nosocomial sepsis.~   "
4107|NCT03513133|"~     The aim of this study is to assess the brain correlates, as assessed with multimodal MRI, of~     working memory training in patients with severe traumatic brain injury (TBI)~   "
4108|NCT03513120|"~     The primary purpose of this prospective study is to determine when adolescent athletes with~     idiopathic scoliosis are able to return to sports participation after posterior spinal fusion~     surgery.~   "
4109|NCT03513107|"~     To demonstrate the predictive ability of the different screening scores (i.e. OST, ORAI,~     ABONE, body weight criterion, age alone or others) and their potential use in the primary~     care setting.~   "
4110|NCT03513094|"~     The purpose of this study is to study the effects of core activation on knee joint loading~     during ambulation in patients with knee osteoarthritis (OA). This study aims to investigate~     the effects of transversus abdominis (TA) activation during simultaneous kinetic analysis of~     time to initial peak ground reaction force (T1) at the heel in the sagittal plane.~      The objective of this study is to determine whether patients with knee OA demonstrate changes~     in T1 during comfortable gait speeds when actively contracting the TA muscle. In addition,~     this study will serve as a pilot study in order to perform a post-hoc power analysis for~     future study on the effects of the independent variable (TA contraction/changes in core~     stability) on the dependent variable (T1).~      Null hypothesis: There will be no change in T1 in patients with knee OA during gait while~     contracting their TA.~      Alternate hypothesis: There will be a decrease in T1 in patients with knee OA during gait~     while contracting their TA.~   "
4177|NCT03512223|"~     This study aims to evaluate the if the administration of dexamethasone both around the nerve~     and in the vein (perineural and intravenous (IV)) will prolong the duration of pain relief~     from ropivacaine when compared with ropivacaine local block alone or when administered along~     with IV dexamethasone in patients undergoing hand surgery.~   "
8694|NCT03453073|"~     The investigators will conduct an epidemiological analysis of data from the Women's Health~     Initiative to investigate the prospective association between chocolate intake and the risk~     of heart disease and stroke.~   "
4111|NCT03513081|"~     The aim of this project is to investigate the efficacy of taste exposure-plus small reward in~     acceptance and consumption of vegetables among preschool children at school. In this context,~     interventions were attended at school in order to capture the influence of this environments~     towards consumption of vegetables among preschool children. For this, the methodology applied~     will be a repeated exposure protocol by introducing small rewards to encourage children to~     taste an unfamiliar or dislike food. Child intake (weight or number of pieces) and liking~     (hedonic scale) will be assessed at baseline sessions and exposure sessions. Moreover,~     child's neophobia will be evaluated and additional determinants of child neophobia, such as~     child's eating behaviour~   "
4112|NCT03513068|"~     To evaluate changes in activity based on the use of portable oxygen concentrators combined~     with standard of care (SOC) long- term oxygen therapy versus SOC long-term oxygen therapy~     alone at 12 weeks in patients with COPD who require continuous (24/7) long-term oxygen~     therapy. The study will also assess oxygen usage, quality of life, hospitalizations and~     death.~   "
4113|NCT03513055|"~     To compare patients and nurses using insulin pen injector to inject premixed insulin~     respectively, using continuous glucose monitoring system to evaluate the glucose excursion in~     the two sets, study the relationship between glucose excursion and inject technique in type 2~     diabetes mellitus.~   "
4114|NCT03513042|"~     The goal of this project is to develop and characterise an imaging strategy for~     biology-guided individualisation of the proton therapy plan to improve patient outcome and~     quality-of-life.~      Positron-emission tomography (PET) studies reflecting glucose metabolism, hypoxia and~     physical changes of proton-irradiated tumour tissues will be performed. Patients with head~     and neck cancer will be studied, as these individuals frequently experience recurrences~     within the radiation field, often with limited therapeutic options. Severe side-effects and~     functional impairment, deteriorating patients' quality-of-life, limited the use of~     dose-escalation in recent feasibility studies of photon therapy guided by individual~     PET-response. However, proton therapy, currently being introduced in the Netherlands,~     improves the precision of radiotherapy and thereby limits the side-effects caused by~     irradiation of neighbouring healthy tissues. Therefore, in proton therapy dose-escalation to~     improve patient outcome is less restricted by toxicity.~      Using PET-studies of two hallmarks of radioresistance, glucose metabolism and hypoxia,~     side-by-side, before and early in-treatment, the predictive ability of both PET-techniques~     for local recurrence-free survival will be compared. A treatment plan adapted to the~     individual response measured by both procedures and compute tumour-dose and toxicity, will be~     simulated, thereby substantiating feasibility of image-guided adaptive replanning.~     Simultaneously to biological responses, proton therapy-induced physical changes will be~     studied. These atomic changes, dependent on tissue-composition and dose-deposition, are~     measurable by PET. It is expected that activation-PET to measure tissue-changes during~     therapy, a potential new biomarker of treatment efficacy, toxicity but also accuracy of~     treatment plan execution. Activation-PET will be related to earlier-mentioned PET-imaging of~     metabolism.~      This clinical-technological project paves the way for an interventional trial of PET-guided~     treatment personalisation. Activation-PET will also serve as biomarker and quality control~     for proton therapy and support the current development of specialised in-beam PET-technology.~     These PET-techniques together will help us to individualise treatment, which is of great~     importance for the success and cost-effectiveness of proton therapy.~   "
4115|NCT03513029|"~     VITAL is a prospective, single arm, multicenter, interventional study to evaluate the safety~     and effectiveness of the VytronUS Ablation System (VAS) for the treatment of symptomatic~     paroxysmal atrial fibrillation (PAF) using low intensity collimated ultrasound (LICU) for~     imaging and ablation.~   "
4116|NCT03513016|"~     A study to evaluate safety, tolerability, and pharmacokinetics of a single intra-articular~     injection of UBX0101 in patients diagnosed with painful osteoarthritis of the knee.~   "
4117|NCT03513003|"~     The aim of the study is to investigate the effect of a pacifier (102 Medical Pacifier,~     Curaprox, Switzerland) on malocclusions like posterior crossbite, anterior open bite, larger~     overjet and tongue dysfunction in young children.~   "
4118|NCT03512990|"~     Introduction~      Interscalene brachial plexus block is the most commonly performed regional anesthesia~     technique to promote analgesia for shoulder surgeries. However, one of limitations is the~     risk of phrenic nerve palsy despite injection of low volumes, being contraindicated in~     patients with limited pulmonary reserve.~      Burckett-St.Laurent et al described an alternative approach to avoid phrenic block - the~     superior trunk approach.~      In this case series, the investigators suggest a modification of Burckett-St.Laurent`s~     technique. The objective of this study is to evaluate efficacy, phrenic nerve function and~     contrast dispersion in cadavers after performing this new approach.~      Materials and methods~      The study was approved by Institutional Review Board of our institution. To perform the~     superior trunk approach described by Burckett-St.Laurent, C5 and C6 nerve roots are~     identified within the interscalene groove and traced distally to where they coalesce into the~     superior trunk, proximal to the takeoff of the suprascapular nerve. Burckett-St.Laurent et al~     suggest spreading local anesthetic around superior trunk at this point.~      The investigators suggest an injection more distally, where superior trunk is in~     costoclavicular space below omohyoid muscle, proximal to the suprascapular outlet. The needle~     is advanced below the prevertebral layer of deep cervical fascia, avoiding that the tip of~     the needle lies in the fascial plane between investing layer of deep vertebral fascia and~     prevertebral layer, a loose fascial plane where lymph node chain is located and may allow~     postero-anterior dispersion toward phrenic. To guarentee right position of the tip the~     investigators suggest an intracluster pattern of spread.~      Patients scheduled for rotator cuff surgery will receive 6 mL of 0,5% bupivacaine in this new~     approach. Successful block is defined as motor score of ≤ 2 on modified Bromage scale in the~     deltoid and bíceps; absent sensation to cold and pinprick sensation in C5 and C6 dermatomes~     within 30 minutes of injection.~      To evaluate phrenic nerve, diaphragmatic excursion will be assessed by ultrasonography of~     ipsilateral hemidiaphragm and impedance tomography. Pain scores and analgesic consumption~     will be assessed in PACU.~      Moreover, 6 mL of methylene blue will be injected into cadavers to evaluate if dispersion is~     restricted to fibers of the superior trunk and don`t reach phrenic nerve.~   "
4119|NCT03512977|"~     This study evaluates effect of sphenopalatine ganglion block in post dural puncture headache.~     Half of participants will receive standard supportive treatment and other half of patients~     will be performed sphenopalatine ganglion block.~   "
4120|NCT03512964|"~     The investigators propose to evaluate Rapid HIV Treatment Initiation in Baltimore in newly~     and previously diagnosed HIV-positive patients not in care through identification of~     barriers, facilitators and acceptability of Rapid HIV Treatment Initiation among newly and~     previously diagnosed HIV-positive patients not in care identified at the Johns Hopkins East~     Baltimore campus and at the Baltimore City Health Department sexually transmitted disease~     clinics. Using this data, a protocol for Rapid HIV Treatment Initiation among newly and~     previously diagnosed HIV-positive patients not in care identified at the Johns Hopkins East~     Baltimore campus and the Baltimore City Health Department sexually transmitted disease~     clinics will be developed and pilot tested. This pilot data will be used to design a~     multi-site study evaluating the effectiveness of Rapid HIV Treatment Initiation versus~     facilitated linkage to care. A model for Rapid HIV Treatment Initiation in Baltimore could be~     generalized to cities where the HIV epidemic has a similar demographic and risk profile such~     as Washington DC, Atlanta, and New York City.~   "
4121|NCT03512951|"~     Within the course of this study, a signal processing algorithm has been developed at Ecole~     Polytechnique Fédérale de Lausanne (EPFL), in collaboration with Sonova AG, in order to~     enhance the listening experience with remote microphone systems. In particular, the developed~     algorithm is supposed to improve the so-called audio-visual fusion, i.e. the fact to perceive~     the sound as coming from the physical location of the source. One of the main goals of the~     present study is to evaluate the extent to which this algorithm reaches that objective.~   "
4122|NCT03512938|"~     Smoking is the major preventable risk factor in the initiation and progression of periodontal~     diseases. Periodontitis risk was found to be 3.9 times higher among smokers aged between~     19-30 years and 2.8 times higher among smokers aged 31-40 years compared to non-smokers.~     Aggressive periodontitis (AgP), is characterized by a rapid attachment loss usually~     incompatible with the amount of plaque and dental calculus. It is often not possible to~     predict the prognosis of treatment with various treatment options in cases of aggressive~     periodontitis. It was hypothesized that non-smoker patients with generalized aggressive~     periodontitis (GAgP) will respond better to conventional mechanical non-surgical periodontal~     therapy compared to the smokers. Therefore, the aim of this study was to evaluate the effects~     of smoking on the outcomes of non-surgical periodontal treatment in terms of the clinical,~     biochemical and microbiological parameters.~   "
4123|NCT03512925|"~     The present study aims at exploring the impact of a standardized debriefing session of~     coercive measures that took place in the psychiatric inpatient setting in reducing the use of~     coercive measures and the subjective perception of coercion. It is well known that coercive~     measures have a major negative impact on the health, well-being and the course of treatment~     of patients suffering from mental health issues. Many interventions have been implemented in~     the last years to reduce the use of coercion and limit its consequences.~      The investigators developed a standardized debriefing intervention of coercive measures. This~     debriefing session takes place as soon as possible after the concerned coercive measure and~     is moderated by a member of staff who has not been involved in the use of coercion. Other~     persons involved are the patient, a staff member who took the decision leading to the use of~     the coercive measure, and a one of the patient's relatives.~      Hypothesis is that the use of this standardized intervention can reduce the use of subsequent~     coercive measures and level of perceived coercion, prevent the development of post-traumatic~     symptoms, help preserving a trustful therapeutic relationship and positively change the~     attitude of staff regarding the use of coercion. This intervention has been proven to be well~     accepted by patients and staff members in a previous pilot study.~      The present study is designed as a randomised-controlled study that compares the standardized~     debriefing intervention with the usual form of debriefing in 7 hospitals.~   "
4124|NCT03512912|"~     Prospective mono-centric trial on patients with peripheral arterial disease and intermittent~     claudication that receive supervised exercise therapy (group 1) vs. supervised exercise~     therapy + daily transcutaneous electro-stimulation of the calf muscles.~   "
4125|NCT03512899|"~     Comparison between internal jugular vein versus via axilar vein with single-incision for~     placement of implantable ports in cancer patients. Investigators are recruiting 240 patients~     and randomizing 120 for each arm. Primary outcome is early complications, until 30 days and~     secondary outcome late complications, between 30 days and 6 months. The follow-up is 12~     months.~   "
4126|NCT03512886|"~     The Activities of Daily Living requires the ability to perform multiple activities at the~     same time, not just the motor or cognitive activity. When many tasks are performed at the~     same time, the attention capacity is effectively used and attention is shared according to~     the difficulty and priority of the tasks. There is evidence that patients with Multiple~     Sclerosis (MS) have reduced performance during multitasking.~      In this study, the investigators aim to investigate the effect of multitasking training on~     balance, mobility, upper extremity performance and cognitive functions in patients with MS.~   "
4127|NCT03512873|"~     56 patients with scleredema diabeticorum will be selected to receive treatment of tranilast.~     After a period of time ,we can determine the efficacy of the drug by detecting the the~     thickness of skin before and after treatment.~   "
4128|NCT03512860|"~     The present study is designed to determine the effect of valproic acid (VAL), a UGT2B7~     inhibiting drug, on the pharmacokinetics (PK) of estetrol (E4)~   "
4129|NCT03512847|"~     The study aims include:~        -  Exploring potential predictive molecular profiles to immunotherapy/chemotherapy~        -  Investigating the role of circulating tumor DNA as a dynamic biomarker during~          immunotherapy/chemotherapy~        -  Identifying possible resistance mechanisms to immunotherapy/chemotherapy~      Materials and methods:~      Approximately 150 patients diagnosed with metastatic NSCLC assigned for immunotherapy or~     chemotherapy will be candidates for inclusion during a 1-2 years period.~      A comprehensive molecular profiling will be made from the diagnostic biopsy. Before every~     treatment-cycle a blood sample will be taken to quantify ctDNA. At time of progressive~     disease during/after first line treatment, patients will be asked to participate in a new~     biopsy and a comprehensive molecular profiling will be performed.~      The tissue and blood samples collected will be stored in a biobank. Clinical data will be~     collected to perform a comprehensive database.~      Analysis:~      Potentially predictive molecular profiles for immunotherapy/chemotherapy will be found by~     comparison of treatment outcome for patients with specific molecular characteristics.~      Through quantification of ctDNA during treatment and upon progression, the role of ctDNA as a~     dynamic biomarker will be further strengthened.~      Differences in molecular profiles pre- and post-treatment may reveal resistance mechanisms to~     treatment. Molecular profiling on progression can be valuable in second-line treatment~     guidance.~   "
4130|NCT03512834|"~     To investigate the efficacy of Avelumab when given in combination with paclitaxel as a first~     line treatment for the patients with inoperable angiosarcoma.~   "
4131|NCT03512821|"~     single-dose, comparative bioavailability study of two formulations of ursodiol 500mg tablets~     under fed conditions~   "
4132|NCT03512808|"~     A single-dose, comparative bioavailability study of two formulations of ursodiol 500mg~     tablets under fasting conditions~   "
4133|NCT03512795|"~     The analysis of HIV resistance to antiretrovirals (Sanger sequencing on RNA) is difficult~     when the viral load is undetectable or during therapeutic breaks. In these situations, the~     high throughput sequencing (SHD) can be done on proviral DNA in order to characterize~     resistant variants with improved specificity.~      This study is a cross-sectional study which will require only one additional tube which can~     be taken during a routine check-up as part of the usual follow-up of the individuals~     included.~   "
4359|NCT03509844|"~     This study compares three established, manual based psychotherapies for Complex~     Post-traumatic Stress disorder (CPTSD) in patients with childhood trauma (e.g. sexual abuse,~     violence). The primary aim of the study is to compare phase-oriented treatment (Stabilization~     + Exposure) with two non-phased treatments, Exposure and Stabilization.~   "
4134|NCT03512782|"~     What is proposed in this project is to develop and evaluate the effectiveness of an online~     remote monitoring system that is easily accessible to patients so that professionals with~     experience in monitoring patients with heart failure (HF) can monitor signs and symptoms of~     decompensation of the disease, as well as self-care actions. A randomized, blind trial for~     outcome evaluation was designed that will include patients hospitalized for acute HF at a~     referral institution in cardiology in southern Brazil. Patients in the intervention group~     will be followed up with a remote monitoring system, accessible by device (computer, tablet~     and cell phone) connected to the internet, by checking for signs, symptoms and self-care~     actions in three moments during 30 days after hospital discharge. Patients in the control~     group will follow up according to the routine of the hospital or physician assistant. The~     primary endpoint for assessing the efficacy of the system will be hospital readmission within~     30 days (follow-up period). The information regarding the signs, symptoms and self-care of~     the patients will be monitored by the research team through an access schedule. The sample~     calculation points to the need to include a total of 142 patients (71 in each group). The~     data will be analyzed through descriptive and analytical statistics. It is hoped that the~     development of a remote monitoring system could be characterized as a strategy for the early~     detection of signs and symptoms of acute decompensation in HF patients, impacting on hospital~     readmission rates within 30 days after discharge. In addition, remote monitoring of signs and~     symptoms may promote improved adherence and self-care of patients. The scientific~     contribution will occur to the extent to which there is innovation in patient follow-up and~     feedback obtained from the patient's interaction with the system.~   "
4135|NCT03512769|"~     Cross sectional observational study to assess the feasibility of using the functional~     prototype of the restful jaw support device to support the jaw when extracting mandibular 3rd~     molars using moderate/deep sedation. An additional meeting(s) will occur, after the oral and~     maxillofacial surgeons (OMS) have completed all treatment procedures utilizing the device and~     surveys are completed, to provide feedback on how the device performed.~   "
4136|NCT03512756|"~     A prospective, open-label phase 2 trial in metastatic pancreatic cancer subjects who have~     failed at least one line of any prior chemotherapy. The trial is designed to evaluate the of~     SM-88 therapy on pancreatic cancer and will measure multiple efficacy and safety endpoints,~     including overall response rate, overall survival, progression free survival, relevant~     biomarkers, quality of life and safety. In the initial stage of the trial (36 subjects), two~     dose levels of SM-88's metyrosine-derivative will be evaluated.~   "
4137|NCT03512743|"~     Large amounts of experimental and animal evidence have confirmed that iron accumulation is~     associated with bone loss. However, it is still lack of the clinical studies relating iron~     accumulation to bone loss, especially in the pathological conditions during our Chinese. In~     this study, the investigators aim to assess the association between the levels of serum~     ferritin and bone mineral density in Chinese healthy postmenopausal women.~   "
4138|NCT03512730|"~     Objective:~      The objective of this study was to evaluate a new mechanical method (Ti-Brush, Straumann, AG,~     Basel, Switzerland) of implant surface decontamination.~      Material and methods:~      A randomized double-blinded controlled clinical trial with a 1-year follow-up it is being~     carried out. After a hygienic phase, defects were randomly assigned to a control (n=18) or to~     a test group (n=18). In control group, implant surface was decontaminated both mechanically~     and chemically with 3% H2O2 and plastic ultrasonic scalers, respectively, while in test group~     Ti-Brush was added. Infrabony defects in both groups were regenerated with BoneCeramic~     (Straumann, AG, Basel Switzerland) and collagen barrier membrane Cytoplast (Osteogenics,~     Lubbock, United States). Clinical and radiographic parameters were measured at baseline, 6,~     and 12 months after surgery.~   "
4139|NCT03512717|"~     The purpose of this study is to evlauate the efficacy and safety of poteinfill, compared to~     the powerfill.~   "
4140|NCT03512704|"~     Objectives: Objective of this project are to create several clinical prediction rules (CPR)~     to stratify patients into different prognostic levels: on arrival at the emergency room, at~     hospital discharge, in the evolution at 90 days, and up to 1 year; for clinical parameters~     (mortality, complications, readmissions) and the evolution of the patient health related~     quality of life. Additional objectives include the analysis of equity in access, continuity~     of care after discharge, costs, psychosocial support received, and variability in clinical~     decisions and in the results obtained from inclusion in the study after the visit to the~     emergency room until 1 year of follow-up. Methods: Prospective observational cohort study~     with a one year follow-up. Multicenter and coordinated study with 9 hospital in Spain. This~     project will include around 1000 patients diagnosed of heart failure who come to emergency~     services of these hospitals, whether discharge home or admitted to the hospital. Multiple~     parameters (about the process of care, clinical outcomes, and quality of life), will be~     retrieved in the emergency room visits, admission, discharge and up to one year follow up~     after discharge. This project bases its work in the large number of variables to be collected~     and would not be viable with few centers, so centers from other communities will collaborate~     providing more cases.~      Statistical analysis using multivariate logistic regression models or Cox or general linear~     models or multilevel analysis will derive the CPR in a subsample of the original sample which~     will be validated in another different subsample.~   "
4141|NCT03512691|"~     This study seeks to assess how beliefs about health risks, specifically the risk of~     cardiovascular disease (CVD), affect health lifestyles and the demand for preventive care in~     a low-income setting. It also aims to establish the effectiveness of the Package of Essential~     Noncommunicable Disease Interventions in the Philippines (PhilPEN) in delivering primary~     prevention of CVD. To meet these objectives, the study is designed as a randomized parallel~     experiment with two separate, non-overlapping treatment groups and one control group. The~     experiment will be implemented in Nueva Ecija province, Philippines.~   "
4152|NCT03512548|"~     This is an open label, single sequence, crossover study. In Part 1, eligible subjects will~     participate in 3 treatment periods, in which they will receive the following treatments in~     turn: 1) In Period 1, a single 350 mg dose of relacorilant administered alone, 2) In Period~     2, once daily 200 mg doses of itraconazole administered for 3 days; 3) In Period 3, single~     350-mg dose of relacorilant administered with a concomitant 200 mg dose of itraconazole and~     continued once daily 200 mg doses of itraconazole for three additional days.~      If Part 2 is conducted, eligible subjects will participate in 3 treatment periods, in which~     they will receive the following treatments in turn: 1) In Period A, 14 days of oral dosing~     with higher dose relacorilant alone; 2) In Period B, 14 days of oral dosing with lower~     dose relacorilant alone; 3) In Period C, 14 days of oral dosing with lower dose~     relacorilant in combination with itraconazole.~   "
4360|NCT03509831|"~     Assess the Safety and the Pharmacokinetic Characteristics of INT-2150 after Oral~     Administration to Healthy Adult Male Subjects~   "
4361|NCT03509818|"~     Exercise program in serum Klotho levels~   "
4142|NCT03512678|"~     Light microscopy, which is based on century-old technology, remains a key indicator in drug~     efficacy testing performed in the context of clinical trials for monitoring existing~     antimalarial drugs or in the context of regulatory clinical trials for registration of new~     drugs. It is one of the main diagnostic methods for malaria diagnosis in general, as in an~     ideal setting it can provide low-cost accurate diagnosis, determine the density of parasites~     in the blood, and accurately differentiate between different malaria parasite species,~     characteristics vital to the implementation of global plans for drug efficacy monitoring.~     Malaria rapid tests (RDTs), while useful for rapid diagnosis and case management, do not~     provide information on the parasite density nor the species differentiation necessary for~     research and drug efficacy assessment. Microscopy therefore retains key advantages over a~     number of newer technologies, but its reliability is severely impeded by dependence on high~     technical competence of the human operators as well as availability of high quality equipment~     and reagents. Recent studies have demonstrated frequent poor specificity and sensitivity~     associated with manual microscopy diagnostics in operational conditions. These drawbacks~     constitute a major limiting factor to effective monitoring and preservation of vital~     anti-malarial medicines.~      Advances in digital microscopy performance and affordability have now opened the door to~     potentially significant improvements in the performance of malaria microscopy, overcoming~     serious deficiencies in current drug efficacy assessment, and more broadly in malaria~     diagnosis and management. Global Good (GG)/Intellectual Ventures Laboratory (IVL) sponsored~     by the Global Good Fund, has developed a microscope prototype consisting of low cost~     components to scan and capture images from Giemsa-stained thick blood films on slides. The~     captured images are analyzed with custom image analysis software developed at GG/IVL, using~     algorithms that are designed for automatic malaria diagnosis, without user input. Versions of~     a prototype of the device were first tested in field settings in Thailand in 2014-2015 at~     clinics operated by the Shoklo Malaria Research Unit (SMRU) and then again in 2016-2017. When~     compared to expert microscopy at SMRU, the performance of the device with respect to~     diagnostic sensitivity (87.8%), species identification (85.6% species correctly identified)~     and parasite density estimation (44% of estimates within +/-25% of reference microscopy~     result) corresponded to WHO Competence Level 2. The device and the accompanying image~     analysis algorithms have since been further developed and a new, third version of the~     prototype is now available for testing in diverse settings with varying malaria prevalence~     and user expertise.~   "
4143|NCT03512665|"~     Metabolic and cardiovascular diseases are the first cause of morbidity and mortality~     throughout the world, including Latin America and Colombia. Asymptomatic elevations of blood~     glucose, insufficient response to normal insulin concentrations (called insulin resistance),~     overweight and obesity can cause severe damage to body organs, leading to complications and~     even death. Worryingly, the prevalence of prediabetes is on the rise and efforts in public~     health policies made to contain this epidemic have had a very limited impact. This has~     prompted an intense search for non-pharmacological interventions. One of the most promising~     areas is research on nutraceuticals, foods capable of positively impacting risk factors.~     However, there are insufficient nutritional or supplementary alternatives to favorably impact~     carbohydrate metabolism and cardiovascular risk factors in individuals at risk of diabetes.~     This project will evaluate the effects of the administration of a dietary supplement composed~     of vegetable oils. The fat composition of these oils is likely to impact positively on the~     metabolic profile of subjects at risk of diabetes and cardiovascular conditions.~   "
4144|NCT03512652|"~     The device Patello was designed to passively mobilize the Patella in cranial-caudal~     direction. Its application field lays in the rehabilitation of any knee pathology where knee~     range of motion may be restricted due to the Patella mobility.~   "
4145|NCT03512639|"~     Arnica montana and Bellis perennis for Prevention of Seroma Following Mastectomy.~   "
4146|NCT03512626|"~     This study evaluated visual outcome after cataract surgery with bilateral implantation of~     either a diffractive - refractive (hybrid) multifocal intraocular lens (MFIOL) or monofocal~     intraocular lens (IOL) as a control grup.~   "
4147|NCT03512613|"~     Congenital heart defects have an incidence of 9/1000 live births. Infants with congenital~     heart defects such as Transposition of Great Arteries / Hypoplastic Left Heart are at risk~     for brain injury because of concomitant brain malformations. Previous studies of cerebral MRI~     in infants with congenital heart defects showed that in 20-40% of cases there was~     preoperative brain injury and post operative with the same incidence. These findings are~     strongly associated with early and long-term neurodevelopmental injury.~      There is a necessity for a non invasive device who will monitor the cerebral blood flow~     during the hospitalization prior and post the cardiac defect repair surgery.~      The previous modal of the study device has been cleared for marketing by the FDA (k150268).~      The main goal of this study is to demonstrate that the new design of Ornim's c-FLOW 3310-P is~     easy to operate and effective in monitoring changes in cerebral blood flow in neonates as~     demonstrated in adults.~   "
4148|NCT03512600|"~     The present study aims to assess the effectiveness of theobromine, -product present in high~     proportion in the cacao-, to prevent the development of uric acid kidney stones.~   "
4149|NCT03512587|"~     The objetive of the study is to evaluate the effect of personalized quantum sonotherapy on~     the level of anxiety and pain in outpatients schedule for orthopedic surgery under regional~     anesthesia in a second level center. The investigators believed that personalized quantum~     sonotherapy could reduce the levels of anxiety and pain before and after surgery evaluated~     through hemodynamic variables and scales for pain (analogous visual scale) and anxiety (STAI~     Spielberger anxious state questionnaire).~   "
4150|NCT03512574|"~     Pregabalin and dexmedetomidine have been introduced to manage postoperative pain. The present~     study aimed to evaluate the effect of the combination of two drugs on pain relief in patients~     undergoing total knee or hip arthroplasty under spinal anesthesia~   "
4151|NCT03512561|"~     .A surgical intervention involves the participant and his / her family in a very stressful~     situation with a biopsychosocial alteration of the participant, often presenting a lack of~     knowledge of the surgical process from admission to hospital discharge. Researchers (nursing)~     began to make prior visits to the surgical procedure to reduce anxiety and provide~     information about the surgical process. The importance of the presurgical nursing visit (PNV)~     is sought, how to achieve a better health education throughout the surgical process, improve~     communication between professionals through standardized records, contributing to an optimal~     approach to the participant, increasing well-being, health and the satisfaction of the~     participant~   "
4159|NCT03512457|"~     The skin self-examination for melanoma (SSE) educational materials were developed with the~     input provided by women undergoing screening mammograms. The investigators seek to evaluate~     the performance of SSE by women and find out if women seek care with a dermatologist for a~     concerning mole or for a melanoma screening examination by a dermatologist after reviewing~     the materials received during the mammogram visit. The purpose of this study is to enhance~     the early detection of melanoma among women who are engaging in health promotion by having~     mammograms. The investigators specifically aim to evaluate the performance of SSE by women,~     who receive information during their mammogram appointment, and then follow-up with~     dermatology for a melanoma screening examination.~   "
4153|NCT03512535|"~     Plasma redox status is well known to alter with age but previously differences have only been~     reported for two specific redox couples; reduced and oxidized cysteine and reduced and~     oxidized glutathione. (Jones DP, Rejuvenation Res. 2006) The overall aim of this project is~     to develop new methods to determine how other Reactive Nitrogen and Sulfur species, such as~     free and protein-bound thiols (organic compounds that contain a Sulfhydryl group, -SH) and~     Hydrogen Sulfide (H2S) change with age and gender in a medium-sized cohort of healthy~     individuals (n=100 of either sex; age 18-70).~      Our group has recently developed a novel analytical platform to measure thiol-containing~     compounds in biological samples that is based on the reaction with the thiol-alkylating agent~     N-ethylmaleimide (NEM). We have used this chemical for years as stabilisation agent in other~     analyses to quantify Nitric Oxide metabolites.(Feelisch et al, FASEB 2002 and Levett et al,~     Sci Rep 2011) We now wish to develop a similar method to measure thiol containing compounds~     using a novel rapid LC-MS/MS based technology for screening large numbers of individuals.~      The project will therefore have 2 stages:~        1. Initial method development will require occasional use of whole blood, plasma and red~          blood cells to establishing optimal conditions. E.g. to compare heparin and EDTA as~          anticoagulants to serum; investigate effects of temperature and pH; identify optimal~          concentration of derivatisation/reduction agents and optimal reaction times.~        2. We then aim to establish the normal distribution of these novel compounds across healthy~          individuals of different gender and varying ages.~   "
4154|NCT03512522|"~     It is well documented that severe pain is more common in older adults than it is younger~     persons. Of concern, older adults may not have access to traditional face-to-face~     self-management programs, which are recognized to be valuable in chronic pain management.~     Access to effective self-management approaches is particularly important for older adults who~     may have mobility limitations or live in remote areas, or have difficulty accessing health~     care services. The development of effective pain self-management programs for older adults~     who cannot access traditional psychological interventions is of significant importance.~     Internet self-management programs have the potential to address pain undermanagement. As~     technology advances, the digital divide between the older and younger demographic continues~     to progress. Given the known difficulties with treatment access, the purpose of this study is~     to explore the efficacy and acceptability of a remotely-delivered chronic pain~     self-management program tailored to older adults, the Pain Course, when delivered in online~     and workbook formats. The program was previously shown to be effective among younger persons~     but has not been tested with older adults.~   "
4155|NCT03512509|"~     The study is a single-blind, randomised crossover study, investigating how a high glycaemic~     potato affects satiety in humans compared to a low glycaemic potato. This is done to shed~     further light on the discussion about whether potatoes with a high glycaemic index increases~     the risk of overweight and obesity and thus indirectly type 2 diabetes and cardiovascular~     disease.~   "
4156|NCT03512496|"~     Caffeine containing energy drinks (CCED) are beverages that typically contain mixtures of~     simple sugars, caffeine and may contain vitamin, mineral and/or herbal preparations. In~     Canada, the consumption of CCEDs among adolescents is a regular occurrence and a common part~     of the everyday diet. Contributing to the obesity epidemic in youth is the consumption of~     energy drinks; yet no data on the metabolic responses to CCEDs exists. This study will~     examine the metabolic implications of CCED consumption in adolescents, aged 13-19 years. The~     investigators hypothesize that CCEDs will impair glucose tolerance by ~30% in lean~     adolescents and the primary cause of the insulin resistance will be caffeine. Obese~     individuals will experience a similar level of glucose impairment, but a greater rise in~     blood glucose compared to their lean counterparts (i.e. higher starting glucose level). For~     many, this additional, caffeine-induced rise will expose them to hyperglycemia, putting some~     individuals in the glucose intolerant or transient diabetic range. It is hypothesized that~     continued metabolic insult resulting from CCEDs may predispose susceptible individuals to~     chronic metabolic diseases later in life. The investigators will also examine the genetic~     basis of caffeine-induced glucose intolerance. This gene-diet interaction could explain why~     caffeine may be much more metabolically harmful for some individuals compared to others. The~     study of 'metabolomics' will also be utilized to analyze caffeine and caffeine metabolites~     such as theobromine, theophylline, and xanthine. This will be accomplished using Nuclear~     Magnetic Resonance (NMR) spectroscopy. Results from this study will have the potential to~     alter current perceptions that CCED are 'harmless' and will have far reaching implications~     for both medical professionals and legislators alike.~   "
4157|NCT03512483|"~     This study evaluates a new model of specialty care for older adults in rural communities with~     Atrial Fibrillation (AF) compared to usual rural physician care. Half the participants will~     receive the new model of specialty care, the Virtual AF Clinic (vAFC), while the other half~     will receive usual care. The vAFC will combine usual care, telehealth appointments with AF~     specialized nurse practitioners/cardiologist, and an educational website. Participants will~     be recruited from rural physician offices and will be followed for 12 months collecting data~     at four time points on AF quality of life, AF knowledge, healthcare utilization (e.g.,~     hospital/emergency department/physician visits), lifestyle behaviors (e.g., physical~     activity), and stroke/bleeding risk. This will generate evidence to determine the feasibility~     of scaling up the vAFC model to other sites.~   "
4158|NCT03512470|"~     The patients will be randomized into two groups of 100 subjects each one. One arm will be~     randomized to treatment with a negative topical pressure system (Sistema Prevena ™); while~     the other arm (control group) will be randomized to treatment with standard medication with~     sterile gauzes and a TNT patch or medicated patch as normal traditional medication in use.~      The medications with a negative topical pressure system (Sistema Prevena ™) will be applied~     directly in the Operating Room. Thereafter the medication will be checked in the inpatient~     ward after 48 hours from the intervention, evaluating the possible absorption of exudate on~     the surface. If no absorption are detected within 48 hours, the medication won't be removed.~     The medication will be renewed in the 7th day (± 2 days) post-operative; and to follow every~     7 (± 2 days) until the points are removed. If the wound continues to progress towards~     recovery, the protocol will continue until discharge and / or rehabilitation and / or~     surgery. For each evaluation the photograph of the medication must be taken (which will be~     deprived of all the identifying elements of the patient).~   "
4160|NCT03512444|"~     Abstract:~      Background: Circumferential negative pressure wound therapy (CNPWT) is commonly used to~     manage wounds and enhance the healing process. A theoretical concern was recently raised that~     CNPWT may have a negative effect on perfusion distally. Objectives: We aim to evaluate the~     effect of circumferential negative pressure therapy (CNPT) on distal O2 saturation in healthy~     volunteers. Design: Randomized controlled non-inferiority study. Methods: Fourteen healthy~     adult volunteers with O2 saturation ≥95% (by index finger pulse oximetry) will be invited to~     participate in the study. After obtaining a written informed consent, CNPWT foam/dressing~     will be applied in a sandwich-like manner on the middle third of each arm and a negative~     intermittent pressure of 125 mmHg will be applied to one arm chosen randomly, using the~     contralateral arm as control. The pressure will be applied 5 minutes on and 2 minutes off for~     9 hours. Individual's participation will be terminated if O2 saturation drops below 92% at~     any study time. The outcome measure is index finger O2 saturation and will be checked every~     30 minutes using a pulse oximetry. The area under the curve (AUC) of O2 saturation in the 2~     arms will be compared using ANCOVA. Sample size was calculated to have 90% power, assuming a~     type one error of 5%, non-inferiority margin of 24 (mean AUC difference), SD of 20, and drop~     out of 2 participants. Importance: The study is expected to provide conclusive evidence on~     the effect of intermittent CNPT on distal O2 saturation. The results would have direct~     implications for CNPWT.~   "
4161|NCT03512431|"~     Repeated 12-hour pharmacokinetic (PK) investigations in renal transplant recipients for~     parallel sampling of standard venous bloods samples and finger prick micro samples (Mitra~     tips). Primary aim to validate the micro sampling tacrolimus concentrations against venous~     blood concentrations.~   "
4162|NCT03512418|"~     This study will deploy a novel, personalized, smartphone-based intervention (PrEPSteps) that~     responds to real time PrEP adherence and non adherence detected through the use of a digital~     pill. The PrEPSteps intervention will be developed and refined through a series of focus~     groups. Participants will be screened at a baseline assessment, they will then use the~     digital pill system for 2 weeks, then undergo randomization to using PrEPSteps + the digital~     pill, or the digital pill alone to measure PrEP adherence. Participants will undergo 3~     monthly study visits where the investigators will assess adherence, conduct pill counts,~     obtain dried blood spots to confirm adherence, provide substance use disorder counseling and~     obtain urine drug screens. At the final study visit, the investigators will conduct a~     semi-structured qualitative interview grounded in the Technology Acceptance Model to~     understand the user response to PrEPSteps and the digital pill.~   "
4163|NCT03512405|"~     This phase I/II studies the side effects of pembrolizumab and blinatumomab and to see how~     well they work in treating participants with acute lymphoblastic leukemia that has come back~     or has not responded to the treatment. Monoclonal antibodies, such as pembrolizumab and~     blinatumomab, may interfere with the ability of tumor cells to grow and spread.~   "
4164|NCT03512392|"~     RADAR-2 will be a randomised, open-label, allocation concealed, pilot trial of conservative~     fluid administration and deresuscitation compared with usual care in patients who are~     critically ill.~   "
4165|NCT03512379|"~     This randomized controlled study was designed to evaluate the accuracy, safety and clinical~     outcomes of the robot assisted spinal surgery.~   "
4166|NCT03512366|"~     Inguinal hernia repair is done by two methods. The conventional method uses a prosthetic mesh~     for strengthening the defect but has been associated with complications. Another new method~     uses a strip of the external oblique aponeurosis to do the same.There is a necessity to~     conduct studies comparing the two methods of hernia repair under local anaesthesia in terms~     of feasibility, economic benefits, faster ambulation with less complications. The purpose of~     the study is to find a method that will lead to faster disposal of patients and early return~     to activities, thereby reducing the waiting list of patients that compromises their financial~     and social spheres and overwhelms the welfare system.~   "
4167|NCT03512353|"~     Describe tolerability and treatment safety of a Kd regimen (Kd 56 mg/m2 [Kd56] twice weekly~     for cycles 1-6 followed by Kd 70 mg/m2 [Kd70] once weekly for cycles 7-12) in subjects with~     relapsed or refractory multiple myeloma with 1-3 prior lines of therapy at study entry.~   "
4168|NCT03512340|"~     This Phase 1/1b, open-label, first-in-human, monotherapy study will be conducted in 2 parts.~     Part A will consist of the SRF231 monotherapy dose-escalation portion of the study, and will~     enroll up to 48 patients with advanced solid tumors and hematological cancers. Part B will~     include monotherapy expansion cohorts in advanced solid and hematologic cancers to further~     examine SRF231 as monotherapy (100 patients total).~   "
4169|NCT03512327|"~     There is limited data to guide the use of dietary change in the management of IBD, and it can~     prove challenging to implement in the setting of altered anatomy, comorbid conditions, and~     patient compliance. Therefore there is an important need to study diet as a therapy for IBD.~     Here, the investigators propose a novel study to evaluate the feasibility and efficacy of the~     autoimmune protocol (AIP) diet in patients with active Crohn's disease (CD) and ulcerative~     colitis (UC).~   "
4170|NCT03512314|"~     This is an open-label extension study for patients previously enrolled in the AB2 Bio Ltd.~     ongoing Phase III clinical trial NLRC4/XIAP.2016.001 (IND N° 127953). This OLE study will~     evaluate the long-term safety and tolerability of Tadekinig alfa in patients suffering from~     pediatric monogenic autoinflammatory diseases harboring deleterious mutations of NLRC4 and~     XIAP.~   "
4171|NCT03512301|"~     Cognitive impairment is a significant health problem in the United States, resulting in costs~     over $100 billion a year. We will provide an efficient, effective, and financially~     intelligent solution to Primary Care Physician's to identify cognitive impairment in the~     earliest stages, delay progression through appropriate treatment, and to afford patients the~     opportunity to make future plans at a time when symptoms are mild and patients are able to~     make informed decisions concerning financial and life activities. This has the potential to~     delay devastating effects of cognitive impairment, and to lessen the financial burden on the~     health care system in the United States.~   "
4172|NCT03512288|"~     A Phase 2, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a~     Multivalent Pneumococcal Conjugate Vaccine in Healthy Infants~   "
4173|NCT03512275|"~     Phase 2 study of MABp1 in patients with moderate to severe Hidradenitis Suppurativa.~   "
4174|NCT03512262|"~     A 12 month study to measure the efficacy and safety of abaloparatide in men with~     osteoporosis.~   "
4178|NCT03512210|"~     This study is being done to see if a minimal monitoring approach is effective and safe when~     providing HCV treatment. The minimal monitoring approach will require fewer study visits and~     lab tests with no medication refills. This study is trying to see whether taking an HCV~     treatment with fewer clinic visits and laboratory tests can cure just as many people as the~     standard approach that uses more visits and laboratory tests. The results of this study will~     be compared with what has been observed in other studies using a standard approach.~   "
4179|NCT03512197|"~     The purpose of this study is to confirm the preliminary evidence from early clinical trials~     that midostaurin may provide clinical benefit not only to AML patients with the~     FLT3-mutations but also in FLT3-MN (SR<0.05) AML (FLT3 mutant to wild type signal ratio below~     the 0.05 clinical cut-off).~      This study will evaluate the efficacy and safety of midostaurin in combination with~     daunorubicin or idarubicin and cytarabine for induction and intermediate-dose cytarabine for~     consolidation, and midostaurin single agent post-consolidation therapy in newly diagnosed~     patients with FLT3-MN (SR<0.05) AML.~   "
4180|NCT03512184|"~     This study is for men and women have been diagnosed with non-alcoholic fatty liver disease~     (NAFLD) and will consequently participate in the YMCA's Diabetes Prevention Program.~   "
4181|NCT03512171|"~     Financial decisions are made during pre-retirement age that can influence financial~     well-being for the rest of an individual's life. This proposal aims to construct a more~     comprehensive model of the specific psychological and neural mechanisms that support~     financial decisions in young adulthood and late middle age. In Part 1 of this study (covered~     in Institutional Review Board (IRB) # 141812), middle-age and young adults complete basic~     cognitive, motivational, and decision making tasks and are studied with functional magnetic~     resonance imaging (fMRI) to determine the relation between neural circuit activation and~     individual and age-related differences in decision making. In part II of the study, aspects~     of dopamine functioning are studied using positron emission tomography (PET) scanning to~     determine whether individual differences in dopamine functions are related to the~     decision-making and fMRI measures collected in Part 1 of the study. Dopamine measures include~     baseline D2 receptor availability, amphetamine induced dopamine release and dopamine~     transporter (DAT) levels, which provides a more comprehensive evaluation of dopamine~     functions than in prior studies linking individual differences in dopamine to behavioral,~     cognitive or decision-making traits.~   "
4182|NCT03512158|"~     Lungs of babies born early are not fully developed and they often need a machine to help them~     breathe. The traditional approach to provide this support is with a breathing tube passed~     into the windpipe. However, we know that breathing tubes can cause injury to the fragile~     lungs of premature babies. Providing breathing support through nose-masks instead of~     breathing tubes (called nasal breathing support) is becoming popular, as it is gentler on~     developing lungs. Doctors, in trying to limit the use of support with a breathing tube, are~     using many different forms of nasal breathing support. The most common form is nasal~     continuous positive airway pressure (CPAP) which delivers a constant pressure and the baby~     breathes on his on her own. However, when this strategy is no longer able to support a~     premature baby's breathing, the best way to provide breathing support is not known. Some~     doctors use a strategy called nasal intermittent positive airway pressure (NIPPV) which~     gives the baby artificial breaths through the nose-mask. Others simply increase the pressure~     on nasal CPAP to higher than traditional levels. In the first study of its kind, we will~     compare these two strategies of nasal breathing support given to premature babies.~   "
4183|NCT03512145|"~     An open label, non-randomized, monocentric, interventional investigation in a cohort of adult~     critically ill patients~   "
4184|NCT03512132|"~     A number of arguments suggest that the deterioration in high density lipoproteins (HDL)~     functioning may worsen with the development of nephropathy during type 1 diabetes (T1D).~      The objective of this study will be to investigate to what extent nephropathy in T1D patients~     in the microalbuminuria and macroalbuminuria stages, compared to T1D patients without~     nephropathy, is associated with an alteration in HDL functionality and changes in HDL size~     and composition (lipids with detailed study of phosphates and sphingolipids, main~     lipoproteins, inflammatory markers).~   "
4185|NCT03512119|"~     Cystic Fibrosis related diabetes (CFRD), a major factor of morbid-mortality in CF, is~     characterized by a preclinical phase of glucose intolerance particularly long reaching up to~     10 years.~      At the physiopathology level, insulin secretion is determinant in the glucose tolerance~     abnormalities in CF. Indeed insulin secretion is dependent of the CFTR activity at the beta~     cell surface and inhibition of CFTR leads to a decrease in insulin secretion.~      Recently, the combination of the lumacaftor, a CFTR corrector, with Ivacaftor, a CFTR~     potentiator, was studied in patient with CF homozygous for the Phe508 del CFTR mutation~     patients and showed an improvement of the respiratory state in comparison with the placebo~     group.~      These data suggests that lumacaftor in combination with ivacaftor in targeting CFTR action~     may have an early impact on the insulin-secretion and consequently on the glucose tolerance.~   "
4186|NCT03512106|"~     There are few studies in the treatment of hypertension employing acupuncture as a blood~     pressure regulating technique. The Ministry of Health synthesized the inclusion of~     integrative and complementary practices within the Unique Health System, such as acupuncture.~     Our objective is to verify the effect of the acupuncture session on hypertensive patients,~     measured through ambulatory blood pressure monitoring (ABPM). In this way two groups of~     patients will be selected in a randomized clinical trial. In the first group, Chinese~     traditional acupuncture will be applied and in the second group the acupuncture sham will be~     applied.~   "
4221|NCT03511651|"~     Although positive end-expiratory pressure (PEEP) has been widely used in mechanical~     ventilated patients with acute respiratory distress syndrome (ARDS), how to select the~     optimal PEEP is far from consensus. The application of PEEP may result in beneficial effect~     by recruiting previously collapsed lung areas, harmful effect by over-distending previously~     aerated lung areas, or a combination of the both. The net effect of PEEP in a certain patient~     may depend on the recruitability. Because recruitability varies extremely in ARDS patients~     and strongly correlates with the response to PEEP, estimation of end-expiratory lung volume~     (EELV) may be essential for individualized setting of PEEP. Whether the FRC changes at~     different PEEP levels remains unknown.~   "
4222|NCT03511638|"~     A Study to Document the Safety and Effectiveness of a New OVD When Compared to a Control OVD~   "
4187|NCT03512093|"~     Since 2008, preterm neonates are taking care of in a Special Baby Care Unit (SCBU). Those~     born less than 34 weeks of gestation are followed-up monthly for one year for monitoring~     their hematocrit level, growth and development.~      Medical chart reviews are useful to evaluate the burden of diseases, characterize care~     treatment patterns and clinical outcomes by patients' subgroups; ultimately it can help~     identifying gaps in care pathways thus improving quality of care and ultimately reducing~     mortality. Medical records of all preterm neonates hospitalized in the SCBU including those~     followed up during their first year of life are computerized.~      The investigators propose to review the clinical charts of the preterm neonates in regards to~     four main points of care a) feeding, b) infections including early onset of neonatal sepsis,~     necrotizing enterocolitis and umbilical cord infection, c) body temperature control and d)~     respiratory distress.~      This medical charts review will be complemented by i) focus group discussions (FGD) with the~     medical staff working in the SCBU on the benefits and difficulties in using the existing~     guidelines for preterm care and by ii) interviews with mothers who delivered a preterm~     neonate on their experience in caring for their child and the challenges they faced.~      While performing the retrospective part of the project and after discussing the preliminary~     findings from the medical staff perception of the existing guidelines, the investigators will~     evaluate the feasibility to implement some additional recommendations to improve preterm~     birth outcomes based on recent literature and new protocols for resource-limited settings.~   "
4188|NCT03512080|"~     This research programme aims to translate expertise in warfarin anticoagulation from~     resource-rich to low and middle income countries (LMIC)settings with the goal of improving~     patient health outcomes.~      An observational study which will be used to develop warfarin dosing algorithms - the~     ultimate aim will be to ascertain whether these algorithms increase time in the therapeutic~     range, reduce bleeding and thrombotic risks, and clinic visits for International Normalised~     ratio (INR) monitoring. Two algorithms will be developed: the first will take into account~     clinical and geographical factors (clinical algorithm), while the second will also~     incorporate genetic factors in addition to the clinical and geographical factors (genetic~     algorithm). Patients will be recruited from sites in rural and urban Uganda, and in Cape~     Town, South Africa, to develop a clinical dosing algorithm. It is important to note that~     there is a wealth of literature data which will be used to define the clinical data that~     needs to be collected from these patients. To identify genetic factors in African patients,~     Genome-wide Association Study (GWAS) will be undertaken and any novel factors incorporated~     into the genetic algorithm - the percentage variation in warfarin dosing explained by the~     genetic algorithm will be compared with the clinical algorithm.~   "
4189|NCT03512067|"~     BACKGROUND AND SIGNIFICANCE Entrainment-based ventilation is a new mode of mechanical~     ventilation based on the classical physics theory of mutual entrainment between coupled~     oscillators. Typically, the entrained inspiratory activity may precede or lag behind machine~     inflation depending on whether spontaneous respiratory frequency is higher or lower than the~     ventilator frequency.~      HYPOTHESIS The investigators anticipate that the results of the study will help to improve~     the interaction of patients with the mechanical ventilator thereby minimizing the risks of~     mechanical ventilation in future. The investigators believe the potential benefits~     significantly outweigh the potential risks.~      RESEARCH STUDY DESIGN AND METHODS This is a prospective study and single site. Twenty~     mechanically ventilated patients, stable on their current vent settings and are capable of~     triggering the ventilator in the SICU, MICU, CCU and Cardiac and Neuro Surgery ICUs at BWH~     will be recruited.~      After obtaining informed consent a respiratory real-time data monitor will be placed between~     the artificial airway and the Y piece of the ventilator circuit. Baseline mechanical~     ventilation data with conventional pressure-limited assist/control ventilation mode will then~     be collected for a 4-hour period. The patients will then be transitioned to pressure-limited~     entrainment-based ventilation for a 4-hour period. Baseline ventilation monitoring will be~     carried out either immediately preceding or immediately following EMV in the same patient.~     The sequence of the control/baseline phase and the experimental phase of the study will be~     randomized.~      DATA COLLECTION Demographic data, weight, height, and past and current medical history will~     be recorded. Also hospital admission information, reasons of mechanical ventilation, mode of~     mechanical ventilation and settings, arterial blood gas, clinical laboratory~     (hematology/chemistry) values, and hemodynamic values will be recorded.~      STATISTICAL ANALYSIS Baseline demographic and procedural variables will be analyzed~     statistically by plotting the 95% confidence intervals of each variable. For feasibility~     evaluation, the total number of each type of asynchronous breaths/hour during~     entrainment-based ventilation will be averaged over the 4-hour experimental period and~     compared with those in the 4-hour baseline ventilation period.~   "
4190|NCT03512054|"~     Tracheotomy weaning and decannulation are one of the important problems in the neurosurgical~     care unit. Aside from medical, psychological, sociological, economical and ethics problems,~     tracheotomy increases the duration of the hospital stay and conditions the secondarily future~     medical care (better re-education after the injury).~      However, according to investigators practices, that patients who were decannulated with~     success can go into a secondary care residence more easily.~      This research will demonstrate that all patients included can be decannulated without risk of~     a new recannulation in the 96 hours.~   "
4191|NCT03512041|"~     The purpose of this research study is to determine the effect of number of remote limb~     ischemic conditioning (RLIC) cycles on enhancing learning in neurologically intact young~     adults.~   "
4192|NCT03512028|"~     The purpose of this research study is to determine if remote limb ischemic conditioning~     (RLIC) can enhance learning of a motor (balance) and an ecologically valid, complex~     cognitive-motor (driving) task, and increase skeletal muscle strength in~     neurologically-intact young adults.~   "
4193|NCT03512015|"~     Self-management interventions can help patients and their families care for themselves along~     the cancer care continuum. This scenario has witnessed the rapid and ongoing growth in mobile~     technologies, including mobile health (mHealth). LuCApp (Lung Cancer App) is an application~     developed by researchers and lung cancer clinicians to gather symptom data in real time and~     to share it with healthcare professionals. This is a 24-week, two-arm, non-blinded~     multicenter feasibility parallel randomized controlled trial aimed to evaluate the usability~     and effectiveness of LuCApp vs standard care to improve self-management of symptoms and~     health related quality of life in lung cancer patients.~   "
4194|NCT03512002|"~     The purpose of this research study is to determine the effects of a technique called~     High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM®), for~     women in any stage of menopause, who are experiencing menopause-related hot flashes.~   "
4195|NCT03511989|"~     To assess transverse dental and skeletal expansion and stability after SLFIO with no fixation~     of the palatal vault compared to stabilization of the palatal vault with an autogenous bone~     block graft or fixation of the palatal osteotomy site with a biodegradable plate.~      To assess transverse maxillary dental and skeletal expansion and stability after SARME with a~     TB distraction appliance compared to a BB distraction appliance.~   "
4196|NCT03511976|"~     Purpose: The primary purpose of the proposed project is to investigate the efficacy of Tier 1~     and Tier 2 interventions delivered through a Response to Intervention (RTI) framework for~     children with attention-deficit/hyperactivity disorder (ADHD). Further, for children who do~     not respond to initial Tier 2 strategies, the proposed study will assess which additional~     course of intervention is most effective: (1) enhanced Tier 2 strategies or (2) stimulant~     medication. The majority of youth with ADHD are in general education settings, whether~     classified as special education students or not. Thus, experimentally evaluating the efficacy~     of well-developed and evidence-based behavioral interventions within a problem-solving~     framework such as RTI would significantly inform practice within school-based behavioral~     intervention teams.~      Project Activities: This study will employ a sequential multiple assignment randomized trial~     design (SMART). Prior to the beginning of the academic year, students will be randomly~     assigned to one of two conditions: (1) Business as Usual in which children receive whatever~     sequence of academic supports and interventions their teachers, school, and parents would~     typically put into place throughout the entire academic year and (2) an RTI approach to begin~     with Tier 1 classroom-wide management strategies with opportunities to add Tier 2 strategies~     for youth who do not respond to the initial Tier 1 approach.~   "
4197|NCT03511963|"~     This trial is conducted in patients with the recurrent lesion(s) post-surgery or the~     untreated mCRC. After stratification with respect to ECOG PS score, chemo regimen, primary~     tumor location and KRAS and BRAF genotype (complete wild-type/primal type), eligible patients~     are randomized into two arms at 1:1 ratio to receive HLX04 (Arm A) or Bevacizumab (Arm B) in~     combination with one of the protocol-defined chemotherapies, modified FOLFOX6 (mFOLFOX6) or~     XELOX for mCRC until disease progression (PD) or unacceptable toxicity or achieving an~     operable contingency, whichever occurs first. Study evaluation time is defined as up to 40~     weeks after the first dosing of the last randomized patient.~   "
4198|NCT03511950|"~     Peritonitis is a common and devastating complication in patients on peritoneal dialysis (PD).~     It is a known fact that persistent inflammatory state and nutritional deterioration are~     closely associated with increased mortality in PD patients.And resting energy~     expenditure(REE) is significantly increased in acute and chronic inflammation in patients~     with chronic kidney disease (including dialysis patients).However,it is limited to the~     changing trend and duration of REE in peritonitis.Investigators hypothesize that the increase~     in total energy consumption resulting from the increase of REE which may accompany with~     decreased energy intake will lead to negative energy balance and nutritional deterioration,~     which may affect the prognosis of patients.Therefore,a prospective cohort study will be~     designed to dynamically research the change of REE accompanied with the nutrition status in~     peritonitis and provide the basis for peritonitis management in the future.~   "
4199|NCT03511937|"~     Consumption of sugar-sweetened beverages (SSBs) like sodas, sports drinks, and fruit drinks~     remains a pressing public health concern in the United States. Consumption of SSBs remains~     well above recommended levels, and has been linked to obesity, diabetes, and cardiovascular~     disease. In response, policymakers across the U.S. have proposed requiring warning messages~     on SSB containers to inform the public and reduce consumption to healthier levels. While~     online studies find that such warnings reduce intentions to purchase SSBs, no studies have~     yet examined the impact of warnings on actual consumer behavior. The purpose of this~     randomized trial is to determine whether health warnings on sugar-sweetened beverages are~     more effective than control labels at reducing purchases of sugar-sweetened beverages. The~     trial will take place in a mock convenience store. Participants will be randomly assigned to~     a health warnings arm in which all sugar-sweetened beverages in the store are labeled with a~     health warning, or to a control arm in which all sugar-sweetened beverages in the store are~     labeled with a neutral label. Participants will select items to purchase with cash, and~     purchases will be compared across trial arms.~   "
4200|NCT03511924|"~     The study will investigate the effects of an intradialytic resistance training on microRNA´s~     expression and muscle strength in haemodialysis patients.~   "
4201|NCT03511911|"~     1. To explore the correlations among measures of PFM strength between using vaginal~          palpation quantified by modified Oxford Grading Scale and Levator ani testing and~          manometry in PHENIX instrument;~        2. To determine the intra- and inter-rater reliability of PFM strength measured using~          manometry in PHENIX instrument.~   "
4202|NCT03511898|"~     This study is conducted to evaluate the safety of a single intravitreal injection of THR-149.~   "
4203|NCT03511885|"~     EUROASPIRE is a multicentre European study in coronary patients and individuals at high risk~     of developing cardiovascular disease (CVD), describing their management through lifestyle and~     use of drug therapies and providing an objective assessment of clinical implementation of~     current scientific knowledge. Four EUROASPIRE surveys have been carried out by the European~     Society of Cardiology so far: EUROASPIRE I in 1995-1997 in nine countries, EUROASPIRE II in~     1999- 2000 in 15 countries, EUROASPIRE III in 2006-2009 in 22 countries and EUROASPIRE IV in~     2012-2015 in 26 countries. The results showed a wide gap between the recommendations and~     clinical practice with many patients not achieving the lifestyle and medical risk factors~     goals for CVD prevention. The fifth EUROASPIRE survey is planned for 2016-2018 to determine~     in hospital coronary patients and apparently healthy individuals in primary care at high risk~     of developing cardiovascular disease whether the European and national guidelines on~     cardiovascular disease prevention have been followed and if the practice of preventive~     cardiology in EUROASPIRE IV has improved by comparison with those centres which took part in~     EUROASPIRE I, II, III and IV. This survey will also incorporate an assessment of dysglycaemia~     and kidney function in all patients. The main outcome measures will be the proportions of~     coronary and high cardiovascular risk patients achieving the lifestyle, risk factor and~     therapeutic targets for cardiovascular disease prevention. The data collection will be based~     on a review of patient medical records and a patient interview and examination at least 6~     months and at most 3 years after recruiting event. All countries which participated in the~     first three surveys will be invited to take part in EUROASPIRE V. This fifth survey will give~     a unique picture of preventive action by cardiologists and primary care physicians looking~     after patients with coronary disease and individuals at high CVD risk.~   "
4204|NCT03511872|"~     An Evaluation of Peer-led basic life support training course compared with professional-led~     course in a limited resource environment; A randomized controlled trial~   "
4205|NCT03511859|"~     Utilization of circulating-tumor-cell (CTC) and cell free DNA (cfDNA) as novel and~     noninvasive tests for diagnosis confirmation, therapy selection, and cancer surveillance is a~     rapidly growing area of interest. In the wake of FDA approval of a liquid biopsy test, it is~     important for clinicians to acknowledge the obvious clinical utility of liquid biopsy for~     cancer management throughout the course of the disease.~   "
4223|NCT03511625|"~     Patients will be assigned to receive either Depo Medrol or Acthar treatment. A synovial~     biopsy, blood draws, synovial fluid aspiration, and physician assessments will be performed~     before and after initiating treatment.~   "
4206|NCT03511846|"~     This study investigates molecular and physical biomarkers of headaches in order to better~     understand mechanisms of these diseases.~      There are 3 main parts:~        1. Use of capsaicin (active ingredient in hot chili peppers) to trigger release of~          calcitonin gene related peptide - the hypothesis is that this will be different in~          headache subjects compared to controls (and if so might be used to predict how these~          patients will respond to certain medications that modulate calcitonin gene-related~          peptide). Subjects will be given capsaicin as a cream applied to the forehead or the~          inner nostril, or a hot sauce that is ingested.~        2. Use of capsaicin to trigger eye watering - the hypothesis is that oxygen gas will slow~          down the amount of eye watering. Cluster headache patients respond very powerfully to~          oxygen gas but to very little else. The mechanism for oxygen is unknown but in rodents~          there is data that it works on the parasympathetic / lacrimal gland system. This study~          translates rodent data into humans in a non-invasive way to confirm the mechanism of~          this very effective treatment.~        3. Use of ice water to trigger headaches - brain freeze causes a very short-lived but~          intense headache that may cause similar biomarker release as other headache disorders.~          This may be a useful human model for other headache disorders.~   "
4207|NCT03511833|"~     Patients who present with acute traumatic injuries in the pre-hospital setting or to the~     emergency department (ED) are treated with opioids, the current gold standard for severe~     acute pain therapy. Treatment with opioids has many disadvantages: the need of skilled~     manpower to administer the medication IV, numerous side effects- mainly cardiorespiratory~     depression- which necessitates post medication administration continuous monitoring of~     patients. IV administration may be difficult or impossible to provide in a number of extreme~     circumstances. For these reasons, there is a constant search for alternate treatment options~     for pain in acute traumatic injuries. IN ketamine has only recently been studied favorably in~     our department in adults, in an open, prospective study (Shimonovich at al 2016), and~     warrants further investigation in the setting of acute traumatic pain. Ketamine is a safe and~     efficacious analgesic and is overall well received both by patients and physicians. Side~     effects include: hallucinations and dissociation. As opposed to opioids, ketamine does not~     alter patients' respiratory and hemodynamic stability giving ketamine great therapeutic~     potential for pain reduction in trauma patients, pre-hospital patients, and battlefield~     injuries. The study we are conducting is designed to test and analyze the safety and efficacy~     of IN Ketamine compared to IV morphine in a setting of acute traumatic pain in the ED, when~     both medications are administered by the protocol as is customary for treatment of pain in~     the Emergency Medicine department, and will be a prospective, randomized, double blind,~     controlled study.~   "
4208|NCT03511820|"~     Amphotericin B is a polyene antifungal drug used for the treatment of many systemic fungal~     infections. It is associated with many side effects which in some cases can be very severe~     and potentially lethal. Lipo-AB® is a true single bilayer liposomal drug delivery system,~     consisting of unilamellar bilayer liposomes with amphotericin B intercalated within the~     membrane. Prior studies showed that the liposomal formulation of amphotericin B greatly~     reduces the side effects of the parent drug, such as nephrotoxicity. This study is designed~     to evaluate the safety and efficacy of Lipo-AB® in neutropenic patients with persistent fever~     in routine clinical practice in Taiwan.~        1. Primary objective:~           • To evaluate the nephrotoxicity of Lipo-AB® (amphotericin B) treatment in neutropenic~          patients with persistent fever in Taiwan clinical practice.~        2. Secondary objectives:~      (1) To evaluate the safety profile of Lipo-AB® (amphotericin B) in neutropenic patients with~     persistent fever in Taiwan clinical practice.~      (2) To evaluate the treatment efficacy of Lipo-AB® (amphotericin B) in neutropenic patients~     with persistent fever in Taiwan clinical practice.~   "
4209|NCT03511807|"~     Tinnitus, or ringing in the ears, affects 10% to 30% of the population. Of those, 20% have~     tinnitus bothersome enough to seek medical attention. In many people, tinnitus can~     significantly affect the quality of life. At this point in time, there is no effective~     treatment or cure available for tinnitus.~      It has been found that electrical stimulation of the inner ear can reduce and in some cases~     eliminate tinnitus. The purpose of this research is to investigate both acoustic and~     electrical stimulation of the inner ear as a possible treatment of tinnitus.~      In both acoustic and electrical testing conditions, the subjects will be instructed to be~     familiar with a 0-10 ranking scale of loudness. In acoustic testing, the stimulus will be~     presented through headphones in a noiseless environment, and the subject will be asked to~     report on the loudness of the presented sound and the level of the tinnitus at 20-second~     intervals. If the subject cannot perceive the presence of the tinnitus, a value of zero will~     be assigned. A typical sound will be presented for 3 to 6 minutes. Loudness will be reported~     for 1 to 4 minutes after stimulus offset to measure the presence and duration of residual~     inhibition.~      Electrical stimulation will be delivered to the inner ear in three ways, 1. using a cochlear~     implant (implant placed in the inner ear to replace hearing function), 2. Using an electrode~     placed in the ear canal, and 3. using a small needle inserted through the ear drum. Various~     electrical signals will be used to evaluate the reduction in the tinnitus perception by the~     subject. The subjects will rate the loudness of the tinnitus before, during, and after the~     electrical signal. Surveys will be used to evaluate the tinnitus loudness and the quality of~     life of the subjects. Hearing tests will be used before and after the procedures. The long~     term goal of this research is to develop a device to treat tinnitus in people who can hear~     and to develop programs for cochlear implants that help treat tinnitus in deaf people.~   "
4210|NCT03511794|"~     Background:~      Stem cell transplants (SCTs) are important in treating many diseases. There are two main~     types of transplants. Autologous stem cells come from the person getting the cells.~     Allogeneic stem cells come from another person. The risk of hepatitis B virus (HBV) is high~     after allogeneic SCT. Even if a person receives the HBV vaccine after transplant, he or she~     may not really be immune to HBV. The person may become immune only after repeated series of~     the vaccine. Researchers need to learn more about the HBV vaccine in people after transplant~     so it can be most effective.~      Objective:~      To assess the rate of achieved HBV immunity for people who had an SCT who did not become~     immune with the first vaccine series and require 2 or more series.~      Eligibility:~      People who have had at least 1 dose of the HBV vaccine and were enrolled in these protocols:~     99-H-0050, 10-H-0154, and 08-H-0046~      Design:~      Participants will be screened in the other protocols.~      Participants data and medical charts will be reviewed.~      Data from up to 350 participants who had transplants before March 2016 will be reviewed.~      Participants data will be collected:~      Demographic data~      Type of transplant~      Type of donor~      Clinical information about the transplant...~   "
4246|NCT03511313|"~     The purpose of this study is to assess the safety and efficacy of renal denervation with~     sterile irrigated deflectable ablation catheter used in renal artery in primary hypertension~     in China.~   "
4395|NCT03509376|"~     This study is a randomized controlled trial comparing two ADR repair methods: nylon suturing~     and nylon suture with mesh enforcement. The ADR correction is performed simultaneously with~     abdominoplasty/ modified skin reduction abdominoplasty.~   "
4211|NCT03511781|"~     This prospective phase I/II study to assess the clinical toxicity and investigate the~     clinical response of breast cancers to a 10 fraction hypofractionated course of radiation~     therapy in advanced incurable breast cancer patients. This study would also investigate the~     feasibility of voluntary breath hold technique for heart sparing in left sided breast cancer~     patients. An intervention radiation therapy dose of 35 Gray in 10 fractions over 2 weeks, 5~     fractions per week, 1 fraction per day will be studied within this clinical trial. Primary~     objective of the study is to assess the toxicity using CTCAE version 4 and LENTSOMA toxicity~     criteria, in advanced incurable breast cancer patients treated with hypofractionated~     radiotherapy schedule of 35 GY in 10 fractions . Secondary objectives are 1. response rate~     after radiotherapy measured using the PERCIST criteria at 3 months. 2. Change in quality of~     life measured using trial outcome index (TOI) at 2 weeks after radiotherapy. 3. Measure the~     change in PHQ4 score at 2 weeks after radiotherapy.~      Additionally to assess the feasibility of voluntary breath hold technique for heart sparing~     in left sided breast cancer patients and to biobank tissue and blood for future radiobiology~     tests. A total of 30 patients will be recruited in this study. Among these 30 patients at~     least 10 patients will be recruited with left sided breast cancer on which feasibility of~     voluntary breath hold technique for heart sparing will be tested. Patient will be followed up~     weekly during radiotherapy, then monthly for 1st three months, then 3 monthly for two years,~     then 6 monthly for next 3 years.~   "
4212|NCT03511768|"~     The aim of this study is to investigate the clinical value of [18F]aluminum~     fluoride-1,4,7-triazacyclononane-1,4,7-triacetic acid-octreotide（18F-AlF-NOTA-octreotide ）~     positron emission tomography / computed tomography (PET/CT) in patients with neuroendocrine~     neoplasms (NENs).~   "
4213|NCT03511755|"~     This is a 12-Week, multicenter, double-blind, controlled, randomized study assessing change~     in psoriasis severity and level of stress in patients with moderate to severe psoriasis~     treated with TEN. Psoriasis severity and stress levels will be measured at Weeks 0, 4, 8 and~     12.~   "
4214|NCT03511742|"~     Aim of the study is to describe the functional characteristics of Icus in Uganda and their~     @8-day patient characteristics it is a prospective cohort study .All Icus in Uganda will be~     included and their admitted patients followed upto 28 days in the ICU for mortality~   "
4215|NCT03511729|"~     The proposed studies are aimed to measure Tau and P-Tau levels in pre- and postoperative~     blood, urine, feces and saliva, as well as to assess pre- and postoperative neurocognitive~     function in children (3 to 5 years old) who will have surgery under general anesthesia~     (single versus multiple exposures). The studies will establish a system to study biomarkers~     of the anesthesia/surgery-associated neurocognitive impairment in children and generate~     hypothesis that Tau or P-Tau serves as the biomarker of such neurocognitive impairment in~     children.~   "
4216|NCT03511716|"~     Prospective, observational, multi-center trial in which patients with mitral regurgitation~     sufficient to merit mitral valve repair will receive a surgical transvalvular, intra-annular~     Mitral Bridge™ to reduce or eliminate mitral regurgitation.~   "
4217|NCT03511703|"~     This study uses to suppress the growth of tumors, extend the patient's survival time and~     improve the quality of life as much as possible. Through the treatment, the patient is given~     the chance to undergo surgical resection, thereby more effectively prolonging the OS.~     Apatinib is a small-molecule VEGFR tyrosine kinase inhibitor. It mainly treats malignant~     tumors by inhibiting VEGFR and exerting anti-angiogenic effects. Preclinical studies have~     shown that its antitumor effect is better than that of the similar drug PTK787. Phase II~     studies of hepatocellular carcinoma have initially demonstrated the effectiveness and safety~     of apatinib in the treatment of advanced HCC. TACE embolized tumor artery blood supply to~     inhibit tumor growth and shrink tumors. Based on the therapeutic potential of apatinib, and~     TACE in their respective tumors, we designed a prospective exploratory clinical study of this~     patient with advanced liver cancer.~   "
4218|NCT03511690|"~     Participating in genetic cancer risk assessments (GCRA) for hereditary breast and ovarian~     cancer can inform treatment and risk management decisions and improve breast cancer outcomes.~     However, Latina and Black women underuse GCRA services, which may increase breast cancer~     disparities. This study will adapt and test the impact of an easily scalable novel~     Intelligent Tutoring System intervention to enhance GCRA use and improve psychosocial~     outcomes in a clinical sample of underserved Latina and Black women at-risk of hereditary~     breast and ovarian cancer.~   "
4219|NCT03511677|"~     Objective: The aim of the present study was to assess the effectiveness of insole with~     metatarsal support on pain in patients with Morton`s neuroma and the impact of this insole on~     function, load distribution in the plantar region, gait variables, quality of life and~     satisfaction with insole use.~      Methods: A randomized, controlled, double-blind, clinical trial with intent-to-treat~     analysis. Seventy-two patients with Morton`s neuroma were randomly allocated into a study~     group and control group. One week following the baseline evaluation, the study group received~     insole with metatarsal support made of ethyl vinyl acetate and the control group received a~     flat insole of the same material, color and density. The groups were evaluated after 6, 12~     and 24 weeks of insole use. The following assessment parameters employed: pain when walking~     and at rest (END); quality of life (SF-36); foot function (FFI and FHSQ); six-minute walk~     test (6MWT) and foot pressure analysis using the AM Cube FootWalk Pro program.~   "
4220|NCT03511664|"~     The primary objective of this study is to compare overall survival (OS) in patients with~     progressive PSMA-positive mCRPC who receive 177Lu-PSMA-617 in addition to best~     supportive/best standard of care versus patients treated with best supportive/best standard~     of care alone.~      Key secondary objectives are an arm-to-arm comparison of the following:~        -  Radiographic progression-free survival (rPFS)~        -  Response Evaluation Criteria in Solid Tumors (RECIST) response~        -  Time to a first symptomatic skeletal event (SSE)~      Additional Secondary Objectives:~        -  Safety and tolerability of 177Lu-PSMA-617~        -  Health-related quality of life (HRQoL; EQ-5D-5L, FACT-P and Brief Pain Inventory - Short~          Form (BPI-SF))~        -  Health economics~        -  Progression-free survival (PFS) (radiographic, clinical, or prostate-specific antigen~          [PSA] progression-free survival)~        -  Biochemical response as measured by PSA. Alkaline phosphatase [ALP] levels and lactate~          dehydrogenase [LDH] levels will also be measured.~   "
8695|NCT03453060|"~     The purpose of this study is to assess the safety, tolerability and pharmacodynamics of a~     single iv dose of E-WE Thrombin in healthy adult subjects.~   "
4224|NCT03511612|"~     Several methods are available to measure ankle brachial index (ABI) non-invasively. A recent~     scientific statement of the AHA considers the Doppler method as the reference. However~     because Doppler devices are not widely available in primary care, several attempts have been~     made to propose alternative methods, among whom oscillometric methods (automatic blood~     pressure machines) have attracted most attention.~      We hypothesize that:~      - the diagnostic characteristics (i.e. sensitivity, specificity and AUC) of the oscillometric~     method would be very good as compared to the Doppler method.~      the oscillometric method would have better intra- and inter-observer reproducibilities as~     compared to the Doppler method.~   "
4225|NCT03511599|"~     Transcranial magnetic stimulation (rTMS) is an investigational and therapeutic modality that~     impacts the connection strength between neurons by delivering patterned energy. In response~     to this patterned energy neurons fire and adapt by changing their connection strengths. This~     change in connection strengths is believed to be the underlying mechanism whereby this~     intervention has therapeutic benefit for this intervention in conditions such as depression.~     The purpose of this study is to test a means of enhancing the effect of rTMS using a~     medication (cycloserine) that has been shown to augment and stabilize activity dependent~     neuronal changes. The investigators wish to use the motor system, where the associated muscle~     response to brain stimulation can be measured, to probe activity dependent changes in~     connection strength between neurons.~   "
4226|NCT03511586|"~     The objective of the study is a multi-center prospective registry to collect clinical~     outcomes of anatomic and reverse total shoulder arthroplasty.~   "
4227|NCT03511573|"~     The existence of an adipose tissue microbiota causally involved in the triggering of a low~     grade inflammation could resemble what observed in liver fibrosis. To generate microbial~     hypotheses putatively responsible for the onset of liver fibrosis we sequenced the 16SrDNA~     gene from liver biopsies from 36 obese patients (ROLIVER cohort) and describe an original~     mathematical approach to decipher signatures of early stage of liver fibrosis F0, F1, F2.~   "
4228|NCT03511560|"~     This is a one year, prospective, randomized, open-label trial examining once versus twice~     daily tacrolimus dosing regimen using two preparations, extended-release Tacrolimus (Envarsus~     XR) versus twice daily Tacrolimus (Prograf). It will examine kidney function between the two~     groups using estimated glomerular filtration rate (eGFR) and also examine one-year kidney~     outcomes, including graft loss and patient death. Patients will be followed for up to 1 year~     during the open-label study period.~   "
4229|NCT03511547|"~     The aim of the study is to show that patch augmentation in rotatorcuff tear results in lower~     rate of recurrent tendon defects compared without patches.~   "
4230|NCT03511534|"~     The purpose of this study is to provide participants diagnosed with obsessive compulsive~     disorder (OCD) and completed one of the active study protocols at the Rodriguez Lab, with~     open/aftercare treatment.~   "
4231|NCT03511521|"~     Glucocorticoids are known to cause an increase in insulin resistance, leading to~     hyperglycemia, in both diabetic and non-diabetic patients. In both the inpatient and~     outpatient setting, steroids are used for their anti-inflammatory property to treat a variety~     of conditions. There is a paucity of information regarding the best way to treat~     steroid-induced hyperglycemia. In this study we will compare (1) the addition of NPH insulin,~     an intermediate-acting insulin, given at the time of steroid administration to the patient's~     standard basal/bolus insulin to (2) modification of the standard basal-bolus insulin regimen~     which will consist primarily increasing the prandial doses at lunch and supper in order to~     determine which regimen is superior for glycemic control.~   "
4232|NCT03511508|"~     The number of pregnant women affected by chronic diseases such as epilepsy, hypertension and~     thyroid disease is rising, and in the Danish population 15 % of all pregnant women had a~     chronic disease in 2016. Chronic disease increase the risk of complications during pregnancy~     such as preterm birth and caesarian section, while children born of mothers with chronic~     disease have an increased risk of low birthweight, prematurity and birth effects. Moreover,~     pregnant women with chronic disease have an increased risk of post-natal depression and~     report higher rates of anxiety during pregnancy and have described dissatisfaction with the~     communication with care providers about issues such as breastfeeding, lack of coherence~     during the course of pregnancy and after delivery.~      The purpose of this study is to examine the effect of an increased, interdisciplinary,~     coordinated and specialized maternity care multimodal intervention for pregnant women with~     chronic medical disease on the length of hospitalization (during pregnancy and after~     delivery). Secondarily, the purpose is to examine the effect of the intervention on~     psychological well-being and patient satisfaction.~      The investigators hypothesis is that the delivery of an increased interdisciplinary,~     coordinated and specialized intervention targeted pregnant women with pre-existing chronic~     disease will be beneficial for this group of pregnant women's' length of hospitalization~     during pregnancy and after delivery due to improved maternity care and improved self-care.~     Also, the investigators hypothesize that the effect of the intervention will be improved~     psychological well-being and satisfaction with care during pregnancy and after delivery.~   "
4233|NCT03511495|"~     The purpose of this study is to assess the reliability and repeatability of the parameters~     obtained using the Galilei dual-scheimpflug corneal topographer for monitoring progression in~     eyes with keratoconus.~   "
4234|NCT03511482|"~     Asthma is a common lung condition that causes long term breathing difficulties. There is~     currently no cure for asthma but the use of simple inhaler treatments can keep the symptoms~     under control. If asthma symptoms get worse this can lead to an asthma attack which can be~     life-threatening. It has been shown that most of the deaths related to asthma are preventable~     if asthma is managed using the correct treatment plan however a significant proportion of~     patients are not using the right inhalers or not using them properly and do not know how to~     manage their asthma if it gets worse.~      There is currently an unmet need to develop tools that can help improve asthma care, identify~     high risk patients, closely monitor their asthma control in 'real time' and intervene to~     optimise treatment to prevent asthma attacks. Both patients and indeed, the current British~     Thoracic Society (BTS) asthma guidelines recognise that technology has the potential to be~     used to improve asthma care and could lead to reductions in National Health Service (NHS)~     services use and improvements in symptoms.~      Patients with better controlled asthma are less likely to be admitted to hospital and more~     likely to have an improved quality of life. This study aims to evaluate the delivery of an~     asthma service using an online doctor providing remote consultations paired with a~     self-management asthma app. The patients will use the app to input and track their symptoms,~     which will be monitored by a doctor remotely who can provide advice, optimise medications and~     intervene in a timely manner to prevent an asthma attack. The service is interactive, so the~     patient and doctor can communicate with one another 7 days a week by completing a~     consultation or sending messages via the online doctor portal or speaking on the telephone.~     The app will relay information about environmental triggers to the patient to help prevent~     the patient's asthma getting worse. The service will provide a new and potentially more~     convenient way of delivering routine appointments to reduce the numbers that do not attend.~     The patients will be able to watch educational videos stored on the app about asthma to~     potentially improve understanding of their condition. Digital training in inhaler technique~     will be supported with face to face support from pharmacists.~      The goals are to increase adherence to and correct use of medication, help patients~     self-manage dynamically to reduce their risk of an asthma attack (with solutions personalised~     to an individual's triggers) and equip healthcare professionals with the data to identify~     those people at higher risk of an attack.~      This is a before-and-after open interventional study, which means participants' asthma~     control will be compared before and after using the digital asthma management service. It is~     not a randomised study and participants will be given the choice of using a digital service.~     It is a single-centre study which will take place within one Clinical Commissioning Group~     (CCG) in Hampshire (UK), across at least two GP surgeries. It is anticipated that~     approximately 80 patients will be recruited.~      Patients will be provided with this digital asthma service for a period of 6 months of 2018~     and outcomes will be measured using a combination of questionnaires (quality of life, patient~     satisfaction, level of activation) and quantitative measures such as Forced Expired Volume~     over 1 second (FEV1)(measure of airway obstruction), Fractional Exhaled Nitric Oxide (FENO)~     (measure of airway inflammation) and Asthma Control Test Scores (measure of symptom control).~     Feedback from NHS professionals hosting the study and online doctors will also be sought. A~     Health economic model will be generated comparing the digitally enhanced model versus usual~     care. The main outcome of this study is looking at whether this new model of service delivery~     can provide an improvement in asthma control test scores.~   "
4247|NCT03511300|"~     Apathy is a syndrome of reduced motivation, characterized by diminished goal-directed~     behaviours (e.g., lack of effort), decreased goal-oriented cognitions (e.g., lack of~     interest) and blunted affect. Apathy is present in 20-50% of individuals after experiencing a~     stroke. Despite the detrimental impact of reduced goal-directed behaviours and cognitions on~     activities of daily living and cognition in stroke patients, interventions for increasing~     motivation (reducing apathy) have yet to be examined in this population. This study will~     examine the effect of goal-setting instructions on cognitive performance in stroke patients.~     The investigators hypothesize that in stroke patients, goal-setting instructions will improve~     cognitive performance relative to standard instructions. If goal-setting instructions are~     effective in improving cognitive performance, it may indicate that treatments targeting~     apathy could serve as a novel way to improve cognitive outcomes and enhance patient quality~     of life post-stroke.~   "
10591|NCT03428178|"~     Efficacy Study of Gene Therapy for The Treatment of Acute Leber's Hereditary Optic Neuropathy~     (LHON) onset within three months~   "
4235|NCT03511469|"~     The rate of re-dislocation after arthroscopic bankart repair is up to 30%. The most important~     dynamic structure that prevents re-dislocation is the rotator cuff muscles. The aim of our~     study is to investigate the efficacy of contralateral training on patients with arthroscopic~     Bankart surgery. Patients with arthroscopic Bankart surgery will be included in the study.~     The patients will be randomly assigned into 3 groups and the first group will be the control~     group, the second group will be the concentric group and the third group will be the~     eccentric group. Standard rehabilitation program will be applied to all groups until 3 months~     after surgery. Between 2nd and 12nd weeks after surgery, concentric strengthening program~     will be applied to the rotator cuff muscles with isokinetic dynamometer to the 2nd group. In~     group 3, the eccentric strengthening program will be applied to the rotator sheath muscles~     with the same isokinetic dynamometer from the 2nd week until 12nd week .~      The strength of the rotator sheath muscles will be measured in pre-op period, post-op week 12~     and post-op month 6 with the isokinetic dynamometer in all patients. In addition, functional~     tests will be performed in pre-op period and post-op 6 months (Y balance test for upper~     extremity, Closed Kinetic Chain Upper Extremity Stability Test and Medicine Ball Throw Test).~   "
4236|NCT03511456|"~     43% or so of far lateral lumbar disc herniation (FLLDH) occurred at L5/S1, however, the~     surgical treatment is still quite challenging. We conducted a modified PELD technique that~     enable us to remove the extraforaminal herniated disc at L5/S1, through the anatomical space~     surrounded by transverse process, facet joint and sacrum (TFS space). This study is to this~     technique's effect and safety in a one year follow-up.~   "
4237|NCT03511443|"~     A systematic review assessing the role, appropriateness and benefits of the active case~     detection strategy, both proactive and reactive, in low malaria transmission settings. A~     common indication is that more studies should be carried out to optimize the ACD strategy to~     the local context, or to provide evidence for the adoption of improved methods. One possible~     improved method is the use of more accurate diagnostic tools, such as the hsRDT proposed in~     this study, with an increased capacity to detect lower levels of parasitemia. It can provide~     a timely and relevant contribution for their development of national Standard Operating~     Procedures for a screening tool in the reactive case detection strategy.~   "
4238|NCT03511430|"~     This is a prospective, observational study to assess the efficacy of the newly developed~     SVEAT scoring system in identifying low-risk patients who may be eligible for early~     discharge. Various elements of clinical information including Symptoms, Vascular history,~     EKG, Age and Troponin values will be checked and entered on the scoring form to calculate the~     SVEAT risk score. Additionally, HEART score and TIMI risk score will be calculated for the~     same subjects.~      The primary aim is to assess the positive and negative predictive values for the SVEAT index~     for cardiovascular events and compare it to the HEART and TIMI Scores.~   "
4239|NCT03511417|"~     The investigators will examine the effectiveness of selected over-the-counter personal sound~     amplifiers in addressing functional hearing problems in middle-aged listeners with mild~     hearing loss. Many people are unlikely to pay several thousand dollars for hearing aids but~     they likely would be more willing to try a possible solution that is less expensive. When~     faced with counseling these individuals, audiologists are at a loss regarding whether or not~     to suggest that they try this type of technology, since there is virtually no research~     available to verify that these devices actually are helpful, particularly for individuals~     with mild hearing loss. The hypothesis being tested is that personal sound amplifiers can~     improve functional hearing and decrease cognitive load in complex auditory environments.~   "
4240|NCT03511404|"~     Non specific chronic low back pain (LBP) is a debilitating disorder characterized by~     tremendous personal and socioeconomic impact, with long-term sick leave, low quality of life,~     and very high financial costs. Evidence suggests that patients with non specific LBP~     presented with altered muscle activity pattern when compare with healthy people. It has been~     reviewed that exercise therapy was effective for modulation of muscle dysfunction in chronic~     low back pain. However, there is a lack of objective assessment of the pain relief in low~     back pain rehabilitation. Clinical application of surface electromyography (EMG) may provide~     a quantitative and objective tool to evaluate the rehabilitation outcome in patients with non~     specific chronic low back pain before and after treatment.~      Objectives: To verify the usefulness of surface electromyography (EMG) in low back pain (LBP)~     rehabilitation assessment.~      Setting: Out-patient physiotherapy musculoskeletal rehabilitation~   "
4241|NCT03511391|"~     This randomized controlled phase II trial will investigate whether the addition of~     stereotactic body radiotherapy to checkpoint inhibitor treatment in patients with~     non-small-cell lung carcinoma, urothelial carcinoma, renal cell carcinoma, melanoma or~     head-and-neck carcinoma can improve progression-free survival as compared to checkpoint~     inhibitor monotherapy. The primary outcome is progression-free survival; secondary outcomes~     include overall survival, response according to iRecist and Recist v1.1 and toxicity.~   "
4242|NCT03511378|"~     The purpose of this study is to compare the immunogenicity of Peg-filgrastim versus Neulasta®~     as an adjunct to chemotherapy in patients with breast cancer~   "
4243|NCT03511365|"~     Individuals with clinically identified non-alcoholic fatty liver disease will undergo~     baseline evaluation of IL-17 and other inflammatory markers as well as microbiome~     determination. The probiotic formulation VSL#3 450 Billion CFU twice daily will be~     administered for 8 weeks and the determination of Il-17 and microbiome will be repeated. Each~     subject will serve as his or her own control.~   "
4244|NCT03511352|"~     This protocol Sedentary Behavior Interrupted: A randomized crossover trial of acute effects~     on biomarkers of healthy aging in the laboratory (Project 1) is part of a National~     Institutes of Aging Program Grant called Sedentary Time & Aging Mortality and Physical~     Function (STAR). The overall purpose of the STAR program to is to better understand how to~     interrupt sitting time and the consequences for healthy aging in postmenopausal women. This~     protocol (also referred to Project 1 of the STAR program) is a 3-condition randomized~     crossover clinical trial of up to 86 postmenopausal women to test whether different~     interruptions to prolonged sitting improve metabolism.~   "
4245|NCT03511326|"~     Interventional open label prospective and multicentre study conducted in Germany in subjects~     with thin or non-hyperkeratotic and non-pigmented multiple AKs in one anatomical area on the~     face (e.g., forehead or cheek or chin), excluding nose eyelids, lips and mucosa or balding~     scalp, using Luxerm® DL-PDT treatment.~   "
4248|NCT03511287|"~     The aim of this clinical trial is to evaluate, the effects of inspiratory muscle training~     program in inspiratory muscle function, functional capacity, quality of life, lung function,~     breathing pattern and chest wall motion in patients with advanced lung disease. Patients were~     evaluated before the inspiratory muscle training, after 8 weeks of training and at follow-up~     which was performed 3 months after the end of the intervention.~   "
4249|NCT03511274|"~     The evidence to date indicates that educational strategies may be effective at reducing~     antenatal CMV infection, however these have not been tested in the UK.~      In phase 1 of the study, the investigators will co-design an educational intervention with~     pregnant women and families affected by congenital CMV with the aim of reducing the risk of~     acquisition of CMV in pregnancy. In phase 2 of the study, the investigators will use this~     educational intervention in a randomised controlled trial (RCT) as part of a feasibility~     study to generate the data required for the design of a future main RCT. Should the future~     main RCT show that the educational intervention is effective in reducing the risk of primary~     CMV infection in pregnancy, the intervention could be rolled out in the National Health~     Service (NHS). This would have significant benefits to patients and the NHS. No other single~     cause of congenital defects and long-term developmental disability currently provides greater~     opportunity for improved outcomes than the prevention of congenital CMV, therefore trials~     designed to test prevention strategies should be a research priority for the NHS.~   "
4250|NCT03511261|"~     The purpose of the study is to determine whether the formulations of curcumin will effect the~     clinical signs and symptoms and histopathological features in patients with clinical stage 2~     oral submucous fibrosis (OSMF).~   "
4251|NCT03511248|"~     This study evaluates the addition of inorganic dietary nitrate to the optimal treatment of~     patients diagnosed with heart failure with reduced ejection fraction. Some vegetables contain~     large amounts of inorganic nitrate, and research suggests that this nitrate has beneficial~     effects on the heart and blood vessels. We have shown in lab experiments that nitrate has~     positive effects on the heart. We wish to test whether dietary nitrate might be useful in~     halting deterioration and/or improving heart function in patients with heart failure, with a~     specific focus on a marker of poor outcome in heart failure: high uric acid levels. Half of~     the patients will receive nitrate-rich beetroot juice, and the other half a nitrate-deplete~     placebo beetroot juice.~   "
4252|NCT03511235|"~     Medicare is requesting outcome data on patients who received Prolaris testing and were~     prescribed active surveillance (AS). In order to ensure appropriate patient care, it is~     important to understand how this added prognostic information influences the selection and~     durability of AS and corresponding clinical outcomes. To address this knowledge gap, this~     study will evaluate how frequently men with low disease-specific mortality (DSM) risk based~     on Prolaris CCR score and who meet NCCN low-risk criteria initially select AS (AS selection).~     This study also will assess how long Prolaris-tested men who initially select AS remain on~     this course before proceeding to definitive treatment (AS durability), and whether AS~     duration impacts biochemical recurrence (BCR) and metastasis risk in these men. This~     retrospective, observational and multi-site study will combine patient CCR scores with~     longitudinal clinical data to address these questions.~   "
4253|NCT03511222|"~     The investigators hypothesize that vorolanib in combination with checkpoint inhibitors~     (pembrolizumab for gastric/gastroesophageal (GE) junction cancers and nivolumab for~     hepatocellular carcinoma (HCC)) may improve immunotherapy efficacy by overcoming treatment~     resistance of checkpoint inhibitors in gastrointestinal (GI) cancers.~   "
4254|NCT03511209|"~     Sleeping medications, called hypnotics, are often prescribed for insomnia. About one-quarter~     of Veterans use hypnotics (or bedtime alcohol). Older patients who use hypnotics fall more~     often and have worse memory than those who do not use them. Stopping hypnotics often reverses~     these problems. The Department of Veterans Affairs (VA) is trying to reduce hypnotic use~     among older adults. Currently, there are two main treatments to help patients stop using~     hypnotics. The first treatment involves a slow decrease in the daily dose until the hypnotic~     is ultimately discontinued. For safety, the process of decreasing the daily dose is usually~     supervised by a physician. The second is a treatment for insomnia called cognitive behavioral~     therapy for insomnia (CBTI).~      This study will compare a novel hypnotic tapering method to the usual tapering method offered~     to older Veterans. The purpose of the study is to determine if the novel tapering method is~     more effective than the usual tapering method, both in terms of hypnotic discontinuation and~     improvement in insomnia severity.~      Participants will be recruited from among Veterans 60 years and older who receive care from~     one VA Healthcare System. Following a baseline assessment, participants will be randomly~     assigned to one of the two 8-week treatment groups (66 participants per group). Each~     treatment group will receive CBTI, however, one group will receive the novel tapering program~     and the other group the usual tapering program. Follow-up assessments will be conducted at~     post-treatment and at 6-months after completion of the treatment.~      If the novel tapering program is effective, it will represent a treatment option that can be~     offered to older Veterans who want to discontinue hypnotics. This tapering program could help~     VA healthcare providers adhere to clinical guidelines that recommend benzodiazepine~     discontinuation among older adults. A reduction in chronic hypnotic use may in turn reduce~     the risk of falls and hip fractures, which ultimately may improve the health and quality of~     life of older Veterans who receive healthcare at the VA.~   "
4255|NCT03511196|"~     Adaptive Androgen Deprivation Therapy (ADT) plus Standard of Care. The purpose of this study~     is to develop adaptive therapy for high risk metastatic castration sensitive prostate cancer~     (mCSPC).~   "
4256|NCT03511183|"~     Colorectal cancer will be resistant to Chemotherapy drugs after treated for a period of time~     .In the past, the classical treatment regiment was to change other drug after tumor~     progressed. In theory, the continuous use of such a drug could shortening the patient's drug~     resistance time. It has been shown that the alternate use of the two drug combinations is~     reasonable in clinical. This application can not only further improve the curative effect but~     also significantly reduce the side effects. So the investigators are going to carry out a~     prospective phase II clinical study. The control group change to second-line treatment after~     progression of first-line drugs. The experimental group use the first line and the second~     line,alternately, for every two cycles. The combination of bevacizumab is a first line~     development, and the second line can still be used . Objective to compare the clinical value~     of XELOX + bevacizumab and XELIRI + bevacizumab alternation regimen in the first-line~     treatment of advanced colorectal cancer.~   "
4294|NCT03510689|"~     The overall objective of this study is to use patient-centered in vitro and in vivo models to~     answer the fundamental question of whether or not pathogenic mutations in BRCA1/2 result in~     an increased risk of CV disease~   "
4295|NCT03510676|"~     The aim of the prospective, multicentre, single-arm study is to assess safety and efficacy of~     a drug eluting stent in Nitinol alloy (NiTiDES) in term of vessel patency and composite~     event-free survival rate up to two years follow-up in focal/medium length lesions in patients~     with ischemic obstruction of superficial femoral arteries or/and proximal popliteal arteries.~   "
4257|NCT03511170|"~     Colorectal cancer will be resistant to Chemotherapy drugs after treated for a period of time~     .In the past, the classical treatment regiment was to change other drug after tumor~     progressed. In theory, the continuous use of such a drug could shortening the patient's drug~     resistance time. It has been shown that the alternate use of the two drug combinations is~     reasonable in clinical. This application can not only further improve the curative effect but~     also significantly reduce the side effects. So the investigators are going to carry out a~     prospective phase II clinical study. The control group change to second-line treatment after~     progression of first-line drugs. The experimental group use the first line and the second~     line,alternately, for every two cycles. The combination of bevacizumab is a first line~     development, and the second line can still be used .Objective to compare the clinical value~     of XELOX and XELIRI alternation regimen in the first-line treatment of advanced colorectal~     cancer.~   "
4258|NCT03511157|"~     This study proposes ischemic preconditioning (IPC) as a novel intervention to improve walking~     distance in patients with intermittent claudication.~   "
4259|NCT03511144|"~     A comparison of two Unity Knee™ tissue-balancing techniques by analysing the results from~     X-rays and patient questionnaires.~   "
4260|NCT03511131|"~     This pragmatic trial of an HIV prevention program focuses on HIV risk-reduction in men who~     have sex with men (MSM) ages 13-18. The design is a three-tiered, internet-based HIV~     prevention intervention series that uses a sequential multiple assignment randomized trial~     (SMART) to track adolescent MSM reporting varying degree of sexual risk.The program package~     includes: (1-low risk) a universally-delivered, brief, online sexual health education program~     designed for sexual and gender minority youth regardless of whether they are sexually active~     (Queer Sex Ed); (2-middle risk) a more intensive online intervention designed for diverse~     AMSM engaging in HIV transmission risk behaviors (Keep It Up!), and (3-high risk) the most~     intensive is a motivational interviewing (MI) intervention that will be delivered by MI~     therapists via online videochat (Young Men's Health Project).~   "
4261|NCT03511118|"~     Over half of women in the US who are breastfeeding their infants take prescription drugs. You~     are being asked to participate in this study because you are breastfeeding your infant and~     are currently taking, as part of your medical care, at least one of the drugs we are~     studying. We are interested in studying drugs commonly prescribed to women who are~     breastfeeding so we can learn more about the amount of drug that is transferred to breastmilk~     and estimate how much of drug that is consumed by breastfed infants.~   "
4262|NCT03511105|"~     The primary objective of the study is to investigate the effect of GSK2798745 on~     alveolar-septal barrier permeability following LPS challenge in healthy subjects. The influx~     of protein-rich fluid into the lung due to damage to the alveolar capillary barrier, with~     resultant adverse effects on respiratory function, is a fundamental underlying defect in~     Acute Respiratory Distress Syndrome (ARDS). In this Phase 1, proof-of-mechanism study, a LPS~     challenge will be used as a surrogate injury model to investigate the effects of Transient~     receptor potential vanilloid 4 (TRPV4) channel blockade on alveolar-septal barrier~     permeability in man. This is a randomised, placebo-controlled, parallel group, double-blind~     (sponsor-open), segmental LPS challenge study of GSK2798745 in healthy subjects. Subjects~     will be randomised in a ratio of 1:1 to take 2 single doses of either 4.8 milligrams~     GSK2798745 followed by 2.4 milligrams GSK2798745 after 12 hours or a dose of placebo followed~     by another dose of placebo after 12 hours. The first dose will be administered on Day 1 at 2~     hours before Baseline bronchoalveolar lavage (BAL) sampling from a segment in the left lower~     lobe of lung. LPS 4 nanogram per kilogram will subsequently be instilled into the right~     middle segment and saline control into the lingula segment of the contralateral side. The~     second dose of study treatment will be administered 10 hours after LPS challenge followed by~     post-dose BAL sampling on Day 2. Each subject will take approximately 5 weeks to complete the~     study.~   "
4263|NCT03511092|"~     This study aimed to conduct a double-blind randomized pragmatic trial to evaluate the effects~     of off-the-shelf leucine metabolite supplements HMB-FA, HMB-Ca, alfa-HICA, on resistance~     training-induced changes in body composition, performance and biochemical markers of muscle~     damage. The investigators' working hypothesis is that so long as subjects adhered to a diet~     containing adequate energy and dietary protein, there would be no differences between those~     receiving the leucine metabolites - HMB-FA, HMB-Ca and alfa-HICA - when compared to a placebo~     consuming group.~   "
4264|NCT03511079|"~     Music has often been used in hospitals as a therapy but there is a limited amount of research~     looking at how music actually affects the different molecules in the body, such as cortisol~     (a marker of stress). There is especially a lack of research in the context of surgery. The~     hope is that this study will show that music can be used to minimize some of the side effects~     related to breast surgery and improve the patient experience.~   "
4265|NCT03511066|"~     to evaluate the Efficacy and Safety of CT-P27 comparing placebo~   "
4266|NCT03511053|"~     The purpose of this research is to find out if there are inflammatory biomarkers (also known~     as biological markers) in epidural space that can predict response to an epidural steroid~     injection. This study will also be evaluating whether the results of an EMG study (also known~     as electromyography) can predict the response to an epidural steroid injection.~   "
4267|NCT03511040|"~     The LOVIT study is a European prospective, multi-center, open-label, single-arm feasibility~     trial designed to determine the safety and angiographic effectiveness through 30 days post~     treatment with Lumenate Intraluminal Device in the treatment of symptomatic vasospasm.~   "
4268|NCT03511027|"~     The purpose of this study is to investigate the efficacy of the Karie Automated Medication~     delivery device in enhancing medication adherence among a group of elderly patients with mild~     to moderate cognitive decline.~   "
4269|NCT03511014|"~     The purpose of this study is to evaluate the effect of microcurrent therapy at the knee pain.~   "
4270|NCT03511001|"~     This study compares effects among Latino and African American cigarette smokers who use~     e-cigarettes with those who continue smoking as usual.~   "
4271|NCT03510988|"~     This is a single institution study enrolling women over age 25 with newly diagnosed breast~     cancer and for whom a breast MR has been ordered as standard of care. Subjects will undergo a~     hybrid dedicated Breast PET/MRI in lieu of a breast MRI alone, for evaluation of extent of~     disease prior to surgical and oncologic management. The study will investigate any~     incremental added benefit to breast MRI specificity by the addition of concurrent hybrid~     breast PET.~   "
4272|NCT03510975|"~     The study is aimed to demonstrate the benefits of newly formed written check-list of~     behavioral instructions and investigate its effects on parent's awareness, consciousness and~     motivation toward MNE.~      The parents with children who complain of bed-wetting 3 or more nights per week for at last~     14 days, they was randomly divided into three groups. The parents in Group I were instructed~     only a verbal behavioral therapy, the parents in Group II were instructed a behavioral~     therapy with a written formed check-list for parents to fulfill and the children in Group III~     will received desmopressin treatment plus verbal behavioral therapy. All participants were~     analysed the compliance and response rate of treatment over time period of 8 week.~   "
4273|NCT03510962|"~     The diurnal variation in the flow of saliva and hence the composition of saliva is an~     established fact. Consumption of most types of acidic and sweetened foods and beverages are~     known to reduce the pH of saliva and some of them even reduce it to critical pH levels and~     result in structural damage to the hard tissues of the tooth.~      The purpose of this study is to ascertain the effect of the selected commercially available~     test fruit-juice drink on the salivary pH and assess the buffering capacity of the saliva~     with or without various intervention measures following the exposure to the test fruit-juice~     drink at different time intervals.~   "
4274|NCT03510949|"~     General anaesthesia demands securing patient's airway either with endotracheal tube or~     laryngeal mask (LMA); however, both carry the disadvantage of postoperative soar throat.~     Nasopharyngeal airway (NPA) can be an alternative without the risk of postoperative soar~     throat.6 The primary end point of our study is to assess the incidence of soar throat with~     the use of NPA compared to LMA in patients receiving general anaesthesia during~     blepharoplasty.~   "
4275|NCT03510936|"~     The purpose of this study is to evaluate the effect of probiotics on the gut microbiome of~     infants with jaundice.~   "
4276|NCT03510923|"~     The FANCY study will investigate whether a selective policy of histopathological examination~     of appendices and gallbladders based on the intraoperative findings of the surgeon is safe~     and cost-effective.~   "
4277|NCT03510910|"~     The purpose of this proposed study is to evaluate the efficacy of a multimodal approach to~     analgesia for patient's pain after hip arthroscopy and to also assess if this new approach~     will result in a reduction in post-operative narcotic use.~      This study is a single-center, randomized prospective study comparing post-operative pain~     scores and narcotic consumption between individuals receiving acetaminophen along with a~     reduced quantity of Percocet (to be used as needed for breakthrough pain) and individuals~     receiving Percocet only. Both pain management options are considered to be standard of care.~     Both cohorts will receive aspirin for DVT prophylaxis and celecoxib for heterotopic~     ossification prophylaxis.~      The primary objective of the study are to compare patients' narcotic consumption and reported~     pain following arthroscopic hip surgery, and determine if acetaminophen can provide adequate~     pain relief compared to a narcotic medication.~   "
4278|NCT03510897|"~     This trial is designed to evaluate QPI-1002 versus placebo for the prevention of Major~     Adverse Kidney Events (MAKE) in subjects at high risk for acute kidney injury following~     cardiac surgery. Half of the participants will receive QPI-1002 while the other half will~     receive placebo.~   "
4279|NCT03510884|"~     Primary Objective:~      To evaluate the efficacy of alirocumab administered every 2 weeks (Q2W) versus placebo after~     24 weeks of double-blind (DB) treatment on low-density lipoprotein cholesterol (LDL-C) levels~     in patients with heterozygous familial hypercholesterolemia (heFH) 8 to 17 years of age on~     optimal stable daily dose of statin therapy ± other lipid modifying therapies (LMTs) or a~     stable dose of non-statin LMTs in case of intolerance to statins.~      Secondary Objectives:~        -  To evaluate the efficacy of alirocumab versus placebo on low-density lipoprotein~          cholesterol (LDL-C) levels.~        -  To evaluate the effects of alirocumab versus placebo on other lipid parameters.~        -  To evaluate the safety and tolerability of alirocumab in comparison with placebo.~        -  To evaluate the efficacy, safety, and tolerability of alirocumab after open label~          treatment.~        -  To evaluate the development of anti-alirocumab antibodies.~   "
4280|NCT03510871|"~     Objectives:~        1. To evaluate the efficacy, in terms of tumor shrinkage, objective response rate, and~          down-stage rate, of nivolumab + ipilimumab as neoadjuvant therapy for patients with HCC;~        2. To evaluate the safety profile in patients with HCC who receive neoadjuvant nivolumab +~          ipilimumab treatment;~        3. To collect HCC tumor tissue and peripheral blood samples from the patients for a~          comprehensive biomarker evaluation for nivolumab + ipilimumab immunotherapy.~   "
4281|NCT03510858|"~     In Switzerland, colorectal cancer (CRC) is the third most common cause of death from cancer~     with 1600 persons dying from CRC each year. CRC screening can prevent most of these deaths.~     If screening begins at age 50, with either colonoscopy or faecal immunological test (FIT),~     the absolute risk of dying from CRC at age 80 can be cut in half. The choice between CRC~     screening methods can be seen as preference-sensitive condition. FIT can detect CRC at a~     similar rate as colonoscopy, but cannot detect as many polyps and advanced polyps as~     colonoscopies. Colonoscopy would seem the best choice for patients who want to reduce their~     risk of developing CRC or dying from CRC, but colonoscopy is an invasive procedure with rare~     but serious adverse effects. Patients who choose FIT do not need to prepare their bowels, or~     take a day off, but instead sample their own stool at home and mail the test to the~     laboratory. Offering the choice of test might also increase overall screening rates.~     Guidelines from the US Services Task Force (USPSTF) suggest shared decision making as a~     method for increasing adherence to screening and elicit patients' preferences for screening~     options.~      Family physicians are recognized as the most trusted professional to discuss CRC screening in~     Switzerland. However, many primary care physicians (PCPs) appear to prefer colonoscopy over~     FIT, and the preferred method seems to vary widely between regions. Physician preferences and~     local medical culture likely determine these choices more than patient preference. It may be~     possible to reduce the number of PCPs who prescribe only one screening method by encouraging~     them to diagnose their patient's preferences for screening method. In Switzerland, training~     PCPs with educational support and decision aids increased the number who intend to prescribe~     both screening modalities in equal proportions (prescription of both colonoscopy and FIT in~     equal proportions).~      To implement the intervention and determine how and if it changes PCP practice over time, the~     study will be conducted in quality circles (QCs) of PCPs. QCs are usually groups of 6 to 12~     PCPs who meet regularly to reflect on their practice. QCs are a multifaceted, step-based~     intervention for quality improvement that has gained international traction because they can~     foster long-lasting behaviour change. In Switzerland, 80% of all PCPs attend QC regularly.~     Through QCs following the principles of Plan-Do-Check-Act (PDCA) quality improvement cycles,~     PCPs can find ways to lower structural barriers to screening, assess their screening~     practices, and give each other feedback.~      The study hypothesizes that providing PCPs with evidence summaries on CRC screening, decision~     aids for patients, and sample FIT tests will increase the number of patients screened for~     CRC, better balance the selection of screening methods (colonoscopy vs. FIT), increase the~     proportion of patients with whom PCPs discuss CRC testing, and increase the number of~     patients who make decision for or against CRC screening.~      The outcomes in PCPs of QCs allocated to the intervention group will be compared to those in~     the control group. The outcomes will be measured through anonymous structured patient data~     collected on 40 consecutive patients by PCPs and questionnaires filled by PCPs.~      To ensure that relevant outcomes important for future implementation and dissemination works~     are collected, the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM)~     framework will be followed for structuring the data collection. The RE-AIM framework helps~     structure the collection of data on the characteristics of the participants invited who~     finally participate in the study (Reach), on the integration of the planned intervention in~     their work (Adoption), on the consistency of implementation of the planned intervention by~     study participants (Implementation), on the maintenance of the intervention effects over time~     (Maintenance), and finally, on the effectiveness of the intervention on the planned outcomes~     (Effectiveness). The RE-AIM criteria are useful for identifying the translatability and~     public health impact of this intervention, and for making clear to future stakeholders the~     internal and external validity of study results.~      This study will test the benefits of a multilevel training program in participatory medicine~     designed to help PCPs in Switzerland to better diagnose patient preferences for screening and~     method of screening method (colonoscopy or FIT) through. If the program is successful it will~     increase the proportion of patients who can decide to undergo testing or not and with which~     method. This should increase in number of patients who are screened or intend to be screened~     for CRC, and thus reduce CRC deaths in the longer term.~   "
4282|NCT03510845|"~     A prospective cohort study that will be conducted at Sultan Qaboos University Hospital. It~     aims to determine the outcomes, in terms of, activity level, functional level, subjective~     knee function, range of motion, stability, and failure, among patients with acute ACL~     injuries, who undergo arthroscopic primary ACL repair; and to compare these results with~     patients who undergo arthroscopic ACL reconstruction. To the investigators' knowledge, there~     is a dearth of studies looking into the outcomes of arthroscopic primary ACL repair and this~     going to be the first study in the Middle East. The investigators believe that arthroscopic~     primary ACL repair is superior to arthroscopic ACL reconstruction; and conducting this~     research project will elucidate the previously abandoned facts about acute ACL repair; and~     will eventually have a huge impact in the field of orthopedic surgery.~   "
4283|NCT03510832|"~     EAST-STEMI is the first perspective, multicenter, large-scale registry focusing on the~     evaluation of real-world medical quality (especially PCI quality) and antithrombotic~     strategies in STEMI patients undergoing emergent PCI in a regional representative sample in~     China with 2 years follow-up. Clinical decision support tools (including ischemic score,~     bleeding score, etc) will be developed and validated based on the database. Novel biomarkers~     to predict the prognosis and to support risk stratification will be explored by using the~     blood samples.~   "
4284|NCT03510819|"~     This study aims to evaluate knowledge, Attitude and Practice of intern dentists in emergency~     management of traumatic dental injuries in permanent anterior teeth in children aged from 6~     to 12 years old. A questionnaire survey will be designed to evaluate Knowledge - Attitude -~     and practice (KAP) of intern dentists who met the eligibility criteria.~   "
4285|NCT03510806|"~     This study will examine the effects of nutritional supplement on post-exercise muscle~     soreness as well as recovery of muscle strength and function.~   "
4286|NCT03510793|"~     Ischemia/reperfusion injury following aortic cross-clamping for vascular surgery leads to~     systemic hemodynamic and microcirculatory perturbances. The use of different anesthetic~     regimens may have an impact on tissue perfusion. The aim of this study was to explore changes~     in microvascular perfusion in patients undergoing elective open abdominal aortic aneurysm~     repair under balanced or total intravenous anesthesia. Prospective observational study on 40~     patients scheduled for elective open infrarenal abdominal aortic aneurysm repair, who~     received balanced (desflurane + remifentanil, n=20) or total intravenous anesthesia (TIVA,~     propofol + remifentanil using target-controlled infusion, n=20) according to the clinician's~     decision. A goal-directed hemodynamic management was applied in all patients. Hemodynamics~     and arterial/venous blood gases were compared before anesthesia induction (baseline) and at~     end-surgery. Changes in sublingual microvascular flow and density were assessed with incident~     dark field illumination imaging. Near infrared spectroscopy was applied on the thenar~     eminence with a vascular occlusion test (VOT) to assess variations in the peripheral muscle~     tissue oxygenation and microcirculatory reactivity.~   "
4287|NCT03510780|"~     Currently, the most positive documented outcomes of periodontal regenerative therapy (PRT) in~     intrabony defects (IBDs) have been achieved with a combination of bone grafts ( BGs) and a~     regeneration material like membranes in guided tissue regeneration ( GTR) or enamel matrix~     derivative (EMD) in Induced Periodontal Regeneration ( IPR) technique. Among the graft~     materials only autogenous bone grafts ( ABGs).and demineralized freeze-dried bone allografts~     (DFDBA), are considered regenerative materials.~      Polypeptide growth factors revealed a potential application in PRT periodontal because are~     the biological mediators during wound healing and regeneration and autologous platelet~     concentrates ( PC) constitute a safe and convenient approach to deliver them.~      Among PC, platelet-rich fibrin ( PRF) belongs to a group of second-generation blood~     autologous products prepared by peripheral blood centrifugation without any nonclotting~     agent, so to obtain a dense three-dimensional clot architecture that concentrates platelets,~     fibrin, leukocytes, cytokines, and sustain cellular migration. This clot is then compressed~     to obtain elastic and very strong membranes that can be used directly as membranes or as a~     ﬁlling agent, after chopping, alone or in combination with BGs.~      Several studies demonstrate that PRF is effective in promoting bone regeneration (BR) when~     used alone or in combination with BG during oral/ periodontal surgery.~      To date, there are very few published clinical controlled trials that compare the results of~     PRF + BGs to the outcomes of PRF / BG alone in the treatment of IBDs and no study about PRF +~     ABG in the same defects. Only one case report tested the use of PRF + ABG mixed with bovine~     hydroxyapatite in the treatment of insufficient alveolar ridge width in aesthetic area. The~     aim of the present study is to verify if the combined use of PRF + ABG in the management of~     IBDs may be a treatment modality clinically not inferior to that with EMD + ABG.~   "
4288|NCT03510767|"~     To study the pharmacokinetic characteristics of TQ-B3525 in the human body, recommend a~     reasonable regimen for subsequent research.~   "
4289|NCT03510754|"~     In this study the investigators retrospectively report outcomes of direct transluminal EUS-BD~     in a series of patients with malignant biliary obstruction after failed ERCP as the~     experience of a single Italian center~   "
4290|NCT03510741|"~     This study aims to determine if the addition of Sodium Benzoate and / or NAC to TAU will be~     acceptable and tolerable and result in overall improvement of symptoms, social and cognitive~     functioning in patients with early schizophrenia spectrum disorder.~   "
4291|NCT03510728|"~     Large scale surveys indicate that approximately 68% of college students drink alcohol every~     month and 40% of college students engage in heavy episodic drinking. Despite~     prevention/intervention efforts, problematic alcohol consumption among college students~     continues to result in an estimated 1,800 deaths and 600,000 injuries annually, and~     epidemiological studies demonstrate no appreciable decrease in risk among college students.~     The purpose of the proposed research is to improve extant college-drinking interventions by~     advancing the dissemination methodology and the intervention content (Specific Aim 1). As a~     methodological improvement, rapid advances in mobile computing makes ecological momentary~     interventions (EMIs) increasingly feasible. EMIs refer to interventions that can be delivered~     multiple times and in the moment. EMIs can optimize the timing and location of the~     intervention while also increasing the dose of the intervention. To improve the intervention~     content, the researchers will examine protective behavioral strategies (PBS) to reduce~     alcohol problems, not just alcohol use. PBS are behaviors that one can engage in immediately~     prior to, during, and immediately following alcohol use that limit alcohol use and/or~     alcohol-related harm. Research suggests that PBS use can protect individuals from alcohol~     problems above and beyond its effect on reducing alcohol use. The primary purpose of this~     research is to provide a more powerful test of a PBS intervention's effects on~     alcohol-related consequences by using a technology-based intervention methodology (i.e.,~     EMI). Participants will be randomized into to a fully crossed, 3 (Standard BMI, BMI with a~     PBS component, control) X 2 (PBS-based EMI, Ecological Assessment Only) design. These 6~     conditions will answer several critically important research questions (Specific Aim 2): a)~     does the addition of a PBS component improve the efficacy of a standard BMI, b) does a~     PBS-based EMI improve efficacy over the standard, single session BMI, c) does the combination~     of motivation-based intervention (BMI) with a skills-based intervention (EMI) yield even~     greater decreases in consequences (i.e., moderation). A final purpose of this research is to~     examine PBS norms, PBS perceived effectiveness, and motivation to change PBS use as novel~     mediators of the improved interventions. Results can be used to disseminate more effective~     college drinking interventions that are cheaper and more efficacious.~   "
4292|NCT03510715|"~     Primary Objective:~      To evaluate the efficacy of alirocumab administered every 2 weeks (Q2W), on low-density~     lipoprotein cholesterol (LDL-C) levels of treatment in children with homozygous familial~     hypercholesterolemia (hoFH) 8 to 17 years of age on top of background treatments.~      Secondary Objectives:~        -  To evaluate the efficacy of alirocumab after treatment on LDL-C levels.~        -  To evaluate the effects of alirocumab on other lipid parameters.~        -  To evaluate the safety and tolerability of alirocumab.~   "
4293|NCT03510702|"~     Epigenetics has produced a high impact in biomedical research and is providing new biomarkers~     for the diagnosis and prognosis of diseases. In addition, epigenetics is also contributing to~     analyze the molecular causes underlying diseases, even so periodontal diseases as it has been~     recently reviewed. In this regard, changes in the methylation of genes codifying for~     pro-inflammatory and anti-inflammatory cytokines has been previously reported. miRNAs are~     very promising biomolecules to be used as biomarkers because miRNAs act as signaling~     molecules and participate in many biological processes, such as cellular development,~     differentiation, and apoptosis. The high stability of circulating miRNAs in the RNase-rich~     environment of the bloodstream and also in different biospecimens used in clinical routine,~     make these biomolecules an optimal source of candidate biomarkers. In fact, miRNAs have~     demonstrated their value as dynamic biomarkers in a wide variety of human diseases.~     Therefore, miRNAs can be used for the monitoring of periodontal disease.~      The objective of this research is to analyze the levels of bone remodeling RANKL / OPG~     biomolecular markers, and the epigenetic regulation of these proteins to identify promising~     biomarkers of periodontal disease.~      Material and Methods. Levels of RANKL and OPG will be measured in the gingival crevicular~     fluid (GCF) to assess the state of bone. These samples will be sent to the lab for~     quantification by ELISA method.~      Furthermore, new epigenetic biomarkers based on the identification of high stable microRNAs~     will be identified by qRT-PCR in GCF as feasible tools for diagnosis and monitoring of wide~     range of disease, including periodontal disease.~   "
4296|NCT03510663|"~     To investigate the effects of intravenous administration of OPC-61815 at 16 and 32 mg on~     QT/QTc interval in healthy male subjects~   "
4297|NCT03510650|"~     Hemophagocytic lymphohistiocytosis in adults (HLH) is at 68% mortality whereas 78% of all~     cases remain undiagnosed though therapies are available which clearly reduce mortality. The~     investigators aim to systematically investigate this life-threatening hyperinflammatory~     syndrome in intensive care units (ICU) in order to detect biomarkers that are highly~     sensitive and highly specific for HLH in ICU compared to patients with sepsis.~   "
4298|NCT03510637|"~     The primary purpose of the ANRS 12332 HepNile study cohort is to assess in Real-Life~     condition the efficacy and the safety profile of new Direct Acting Antivirals (DAAs)~     introduced in the Egyptian National Treatment Programme for the treatment of Chronic~     Hepatitis C (CHC).~   "
4299|NCT03510624|"~     Investigate the acute effect of the steviol glycoside, rebaudioside A, on the glucose~     excursion during an oral glucose tolerance test in 30 patients with type 2 diabetes mellitus.~   "
4300|NCT03510611|"~     The main objective of this study is to evaluate the Effect of Food on the Pharmacokinetics of~     Ensartinib Capsules.~   "
4301|NCT03510598|"~     Evaluate the safety and efficacy of subcutaneous fat layer reduction in the submental area~     using multiple therapeutic tools.~   "
4302|NCT03510585|"~     Professionals working in polluted areas may present increased airways symptoms and~     dysfunction. Rhinopharyngeal retrograde clearance (RRC) has been used to improve mucus~     clearance in infants with bronchitis and bronchiolitis. Flushing the nasal cavity with saline~     (S) has been used to reduce nasal inflammation in rhinitis and sinupathies. The aim of this~     study was to assess the effects of RRC and RRC plus S (RRC+S) on the airways in professional~     motorcyclists. Twenty-four male motorcyclists (mean age 36 years) were randomly assigned to~     RRC or RRC+S. Subjects were assessed at baseline and 15 days after interventions for airways~     assessments by saccharin test, mucus contact angle, cellularity in nasal lavage and airways~     symptoms with the use of SNOT-20 questionnaire. Data were analyzed by nonparametric ANOVA for~     repeated measures with Bonferroni´s correction. A passive nitrogen dioxide monitoring system~     was used to assess the mean personal air pollution exposure along the study period (NO2). The~     association between NO2 and the airways outcomes was analyzed by Spearman correlation test.~     At baseline, the two groups were similar in clinical, demographics and working aspects. From~     them, 100% had airways symptoms complaints and 33% had nasal MCC impairment. After~     treatments, both groups presented improvements in airways symptoms and nasal MCC. However,~     increased number of macrophages and ciliated cells were observed in nasal lavage of both~     groups. No associations between nitrogen dioxide and the outcome variables were detected.~     Rhinopharyngeal retrograde clearance seems to be useful in the clinical management of the~     upper airways symptoms and dysfunction in adults.~   "
4303|NCT03510572|"~     The overall goal of this imaging trial is to evaluate [18F]PI-2620, a tau targeted positron~     emission computed tomography radioligand, in individuals with tauopathies and healthy~     volunteers (HV).~   "
4304|NCT03510559|"~     It is very common to perform nerve blocks for hand and wrist surgery. It allows the surgeon~     to perform the surgery and helps with pain control after surgery. This also means only light~     sedation is needed for the procedure instead of a general anesthetic, which speeds up~     recovery time.~      There are 2 types of nerve blocks that can be done for hand and/or wrist surgery. The one~     that is done commonly now is where the whole arm is frozen with local anesthetic. Another~     option is to have a nerve block where only the arm from the elbow down is frozen. Either of~     these types of nerve blocks can be chosen to safely accomplish surgery of the hand or wrist.~     However, the best nerve block for hand and/or wrist surgery has not been decided yet.~      In order to determine which block is best, the investigators will be looking at patient~     satisfaction with the experience, as well as the surgical conditions provided and overall~     safety.~      It is thought that many patients may prefer the arm block below the elbow as it allows for~     greater mobility immediately following surgery, and the surgical conditions provided will be~     very similar to those of the full arm nerve block.~   "
4305|NCT03510546|"~     A randomized, placebo-controlled, double-blinded cross-over study evaluating and quantifying~     the effect of pyridostigmine on muscle strength and symptoms in Myasthenia Gravis (MG)~   "
4306|NCT03510533|"~     This study should lead to the validation of the concept of the autoAc directed against the~     neuropeptides involved in food intake regulation.~   "
4307|NCT03510520|"~     The aim of this study is to evaluate haemodialysis treatment using a medium cut-off dialysis~     membrane (Theranova) compared with on-line haemodiafiltration treatment with respect to~     markers of endothelial health (plasma endothelial microvesicle levels, pro-inflammatory and~     pro-coagulant markers).~      This study will also compare the 2 treatment modalities with respect to several other outcome~     measures including patient-reported outcome measures, haemodynamic parameters and advanced~     glycation end-products.~   "
4308|NCT03510507|"~     Lyme disease is due to Borrelia burgdorferi sensu lato and is transmitted by a tick vector of~     the genus Ixodes. One of the clinical forms of this disease in the disseminated phase is the~     appearance of arthritis, classically mono or oligo-arthritis in the large joints.~   "
4309|NCT03510494|"~     The main aim of this study is to describe differences in development of health and motor~     performance over time in relation to type of school and other background variables.~   "
4314|NCT03510429|"~     Decreased bowel function and loss of appetite in patients who underwent pancreaticobiliary~     surgery contribute impaired nutritional status in postoperative period. It can also affect~     perioperative and oncologic outcomes negatively. Therefore it is important to improve~     nutritional status in postoperative period by supply tailor-made optimal diets. The~     investigators have developed customized postoperative diets and products for~     pancreaticobiliary cancer patients. This time, newly developed ketogenic drink contain~     beefsteak mint.~      The investigators expect that nutritional supplement for pancreaticobiliary patients will~     increase the food intake rate and contribute a improvement of perioperative outcomes and even~     oncologic outcomes.~   "
4315|NCT03510416|"~     Efficacy and Safety of Apatinib Combined With TACE in Patients With Hepatocellular Carcinoma~     Refractory to Transcatheter Arterial Chemoembolization .~   "
4316|NCT03510403|"~     This study evaluates the efficacy, the tolerance and the acceptability/compliance of the~     nasal airway stent, Nastent, for the treatment of mild to moderate OSA and snoring in~     European adult patients without cardiovascular and/or respiratory comorbidities/disorders.~   "
4310|NCT03510481|"~     Background:~      The disease malaria affects many people in Mali and other parts of Africa and the world. It~     is caused by germs spread by mosquito bites. Malaria may be mild. But it can also be serious~     or lead to death if it is not treated promptly. Researchers want to find a safe vaccine that~     prevents malaria.~      Objective:~      To study how safe and tolerable the malaria vaccine called PfSPZ Vaccine is for healthy~     adults.~      Eligibility:~      Healthy adults:~        -  ages 18-35 in Ou(SqrRoot)(Copyright)less(SqrRoot)(Copyright)bougou, Mali~        -  not infected with HIV, Hepatitis B, or Hepatitis C~        -  for females, not pregnant or breastfeeding and must use reliable birth control during~          the study~      Design:~      Participants will be screened with questions about malaria and will undergo blood, urine, and~     heart tests.~      Participants will be randomly assigned to 1 of 4 groups. They will get injections of either~     the PfSPZ vaccine or a salt-water placebo. They will not know which one they get.~      One vaccine group and one placebo group will get an injection 3 times over 4 weeks. They will~     be followed for 7 months for a total of 26 visits.~      The other two groups (vaccine group and placebo) will get an injection 3 times over 16 weeks.~     They will be followed for 11 months for a total of 34 visits.~      All participants will be treated with an antimalarial medication prior to the third~     injection.~      At vaccine visits, female participants will have a pregnancy test before injection. All~     participants will have an arm cleaned and the vaccine injected in a vein. They will be~     watched for 30 minutes.~      At non-vaccine visits, participants will have a physical exam and be asked how they are~     feeling. They will usually have blood tests.~   "
4311|NCT03510468|"~     Background:~      Human immunodeficiency virus (HIV) is treated with antiretroviral drugs. Many people with HIV~     also have the lung infection tuberculosis (TB). Most TB treatments are complicated. A simpler~     treatment of two TB drugs can be taken once a week. Researchers want to study how the HIV and~     TB drugs affect each other so people who take both can be treated safely.~      Objective:~      To study if rifapentine and isoniazid affect blood levels of the common antiretroviral TAF.~      Eligibility:~      Healthy adults ages 18-65 without HIV, TB, or hepatitis~      Design:~      Participants will fast before the screening visit. They will have a medical history, physical~     exam, and blood tests. Women may have a pregnancy test.~      During the study, participants must:~      Use effective birth control~      Not take most medicine~      Not drink alcohol~      At the baseline visit, participants will repeat screening tests and get TAF tablets.~      Participants will take TAF once a day for 31 days. They will keep track of doses and side~     effects.~      Over 32 days, participants will have 4 long visits and 4 short.~      At all visits, participants will:~      Fast the night before~      Get food~      Take that day s TAF~      Review their TAF supply~      Have pregnancy and blood tests~      Report side effects~      At 3 visits, participants will also take the 2 TB drugs and vitamin B6.~      At 3 long visits, participants will also have blood collected 8 times over 8 hours by plastic~     tube in an arm vein.~      Around Day 46, participants will fast and have blood and pregnancy tests. Two weeks later,~     they will get a call to see how they are feeling.~   "
4312|NCT03510455|"~     Background:~      People with tumor-induced osteomalacia (TIO) have small tumors that may cause low blood~     phosphorus, weak muscles, bone pain, and broken bones. The tumors may be so small they are~     hard to find or impossible to remove. Researchers want to test a drug that may help treat~     TIO.~      Objective:~      To see how the drug BGJ398 affects people with tumor-induced osteomalacia.~      Eligibility:~      People ages 18-85 who are in NIH protocol 01-D-0184 and have TIO that cannot be found or~     easily removed~      Design:~      At every study visit, participants will have:~      Medical history~      Physical exam~      Blood and urine tests~      Questions about their health and fatigue~      At the screening visit, participants will also have a heart and eye tests. They may have~     other tests to find their tumor.~      The baseline visit will be a 1-week stay in the clinic. Participants will have the regular~     study tests, plus:~      Their first dose of the study drug capsules~      Blood and urine collected every 2-4 hours for 24 hours. A thin plastic tube will be inserted~     in a vein to collect blood.~      Heart and kidney ultrasounds~      Activities that test strength~      6-minute walk test~      Participants will take the study drug for six 1-month cycles. In each cycle, participants~     will:~      Take the study drug every day for 3 weeks. Not take it for 1 week.~      Have 1 visit. Participants will collect their urine for 24 hours and have their blood drawn.~     Participants will have the regular study tests and repeat some baseline tests.~      Have blood and urine tests at their local lab.~      Participants will have 1 visit at the end of the last cycle and another 3 months later.~   "
4313|NCT03510442|"~     Background:~      Inflammatory conditions can cause symptoms like fevers, arthritis, and rash. Systemic~     juvenile idiopathic arthritis (sJIA) is one of these conditions. So is adult-onset Still s~     disease (AOSD). Their causes are unknown. Researchers want to learn more about these~     conditions. This includes genetic changes and environmental factors.~      Objective:~      To study sJIA and AOSD in children and adults over time.~      Eligibility:~      People with known or suspected sJIA, AOSD, or similar inflammatory condition~      Design:~      Participants will be screened with a phone call.~      Participants will have 1 visit. It may be outpatient or they may be admitted to the clinic.~     The visit may last up to 5 days. Participants will have:~        -  Medical history~        -  Physical exam~        -  Musculoskeletal exam~        -  Questions about overall health and quality of life, disease activity, functional status,~          and cognitive ability.~      Participants may also have:~        -  Pictures taken of their skin, joints, or spine~        -  Blood, urine, and stool tests~        -  Scans or X-rays of joints with arthritis~        -  Chest X-ray~        -  Heart tests~        -  Skin biopsy. The skin will be numbed. The top layers of a small area will be scraped~          off.~      Participants who have a joint aspiration may provide a fluid sample. The joint will be~     prepared, then fluid is removed by needle. A corticosteroid may be injected.~      Participants who have a bone marrow biopsy may provide sample cells.~      Participants may be seen by NIH specialists.~      Members of the participant s family and healthy volunteers may give blood or saliva samples~     for genetic testing.~      Participants may repeat some study tests every 6 months.~   "
4333|NCT03510182|"~     Intensive therapy for aphasia has been demonstrated to improve language functioning after~     stroke or other neurological injury. However, recovery is generally not complete and new~     therapies are needed to improve outcomes. Transcranial direct current stimulation (tDCS) has~     been shown to improve outcomes with motor therapy after stroke. This study will examine the~     feasibility of using tDCS with intensive language therapy as a way of enhancing language~     outcomes in aphasia~   "
4317|NCT03510390|"~     The study evaluates the effects of the drug Metformin on the oxygen content in cancer tissue.~     Low oxygen concentration in cancer tissue accelerates cancer growth. Moreover, the response~     to radiation therapy is worse when tissue oxygen is low, because radiation therapy depends on~     oxygen to unfold therapeutic effects. Metformin has been used to treat type II diabetes for~     over 50 years and features additional properties that could slow down cancer growth. One of~     these properties is the improved oxygen concentration in cancer tissue. This effect has been~     proven for various cancers.~      This study was planned to verify this effect in head and neck cancer. Patients who suffer~     from cancer of the mouth and are planned for surgical removal of the cancer will be given~     Metformin for 9 to 14 days. The tissue removed in the subsequent surgery will be compared to~     a tissue sample that had been taken from the same patient prior to Metformin intake. To~     evaluate the oxygen content in the tissue samples, the expression of genes that react to~     oxygen levels will be measured and compared between the samples taken before and after~     treatment with Metformin.~      A secondary aim is to evaluate whether changes in the oxygen content within the tumor can be~     visualized by means of magnetic resonance imaging (MRI). Therefore, participants undergo an~     MRI scan, before and after Treatment with Metformin. The changes in the MRI will be~     correlated to the changes measured in gene expression.~   "
4318|NCT03510377|"~     Normal aging is associated with balance, mobility and executive functions decline that~     increase fall risk and influence Activity of Daily Living (ADL) and Instrumental ADL (IADL)~     functions such as safe road-crossing, planning and organizing everyday activities. Changes in~     cerebellar functional plasticity may mediate between the decline in balance, mobility and~     executive functions during elderly. Fortunately, mounting evidence suggests that physical~     activity is beneficial for decreasing aging effects and optimize brain structure and~     function. According to the dynamic systems theory, the environment in which the physical~     activity occurs influences the results of the activity. We propose an aquatic physical~     intervention program as a tool to decrease aging effects that in turn might lower fall risk,~     increase safety of road-crossing and improve planning and organizing everyday activities~     among community-dwelling older individuals.~   "
4319|NCT03510364|"~     Investigators examined the associations between SSS, energy balance, food intake and changes~     in body composition following a high calorie lunch for 2 weeks.~   "
4320|NCT03510351|"~     This study will describe clinical outcomes in patients who received ceftolozane-tazobactam~     for a Pseudomonas aeruginosa infection. Primary outcomes include 30-day and in-hospital~     mortality.~   "
4321|NCT03510338|"~     The study will assess a new biphasic release sildenafil formulation (N4S001), developed by N4~     Pharma. The N4S001 tablet contains a total of 100 mg sildenafil.~      The N4S001 tablet is designed to provide a faster onset of release and a longer therapeutic~     window compared to currently marketed sildenafil products.~      This is a single centre, open-label, four-arm crossover study in up to 12 healthy male~     volunteers.~      The following treatments will be dosed:~      Assessment Visit 1: N4S001 tablet containing 100 mg sildenafil (fasted)~      Assessment Visit 2: N4S001 tablet containing 100 mg sildenafil (fed)~      Assessment Visit 3: Viagra film-coated tablet containing 50 mg sildenafil (fasted)~      Assessment Visit 4: Viagra film-coated tablet containing 50 mg sildenafil (fed)~      The immediate release layer of each N4S001 tablet will be radiolabelled to contain 4 MBq~     (megabecquerel) 99mTc at time of dose.~   "
4322|NCT03510325|"~     This project is mainly to clarify the optimal treatment plan and the treatment recommendation~     sequence of different drugs in Chinese first-episode schizophrenia patients,to identify the~     optimized sequential treatment regimen for the treatment of resistance patients and provide~     new evidence for the revision of the guidelines for the treatment of schizophrenia.~   "
4323|NCT03510312|"~     A single-center cohort of patients with acute ischemic stroke and transient ischemic attack~     who admitted to the Severance hospital of Yonsei university and their long-term outcomes.~   "
4324|NCT03510299|"~     Laryngeal Mask Airway Flexible (LMA Flexible) is useful in various surgery because of its~     unique design. The flexometallic tube allows it could be used in head and neck related~     surgery but also make insertion more difficult. The ideal position of LMA Flexible is~     important because in most case, the surgery requiring LMA Flexible allows movements of the~     stem or patient's head during operation without dislodgement of LMA Flexible. Several studies~     have examined different techniques like assisting LMA Flexible with rigid introducers or~     lifting epiglottis with direct laryngoscope. But there is no study using videolaryngoscope~     (VL) for LMA Flexible insertion. The investigator hypothesized that McGrath(McGRATH™ MAC~     video laryngoscope;Aircraft Medical Ltd, UK.), one kind of the VL, assisted insertion would~     increase the success rate of LMA Flexible insertion by lifting epiglottis and securing a view~     while LMA Flexible is seated. The aim of this study was to investigate the efficacy of the~     McGrath VL assisted insertion of LMA Flexible compared with the standard method of digital~     manipulation technique in regard to the ideal anatomical position and sealing pressure in~     anesthetized adult patients.~   "
4325|NCT03510286|"~     This evaluation will aim to generate a body of evidence that will determine performance~     characteristics of the current PrCr dipstick test and the feasibility of its use in target~     ANC settings. Data will be used to inform further product development and/or support~     development of an introduction framework, including the process and associated resources~     needed for incorporation of the PrCr test into future larger-scale demonstration studies as~     well as to support early product launch.~      The objectives of the evaluation are as follows:~      Primary objective: Assess the accuracy of the PrCr dipstick test for detection of proteinuria~     in representative antenatal care settings in Ghana.~      Exploratory objectives:~        -  Understand the feasibility of integrating the use of the PrCr test into ANC services in~          Ghana.~        -  Explore the potential for improved ANC management of PE/E using the PrCr test in~          intended ANC settings versus the current standard of care used for proteinuria~          screening, protein-only determination via a low -cost urine dipstick test.~   "
4358|NCT03509857|"~     In this study, the investigators seek to evaluate the role of vibration in the reduction of~     discomfort associated with painful stimulus associated with anesthesia induction. Through~     this study, the investigators hope to develop a comprehensive and cost-effective approach to~     minimize patient discomfort during anesthesia induction.~   "
11639|NCT03414463|"~     To decrease emotional self-awareness deficits and improve emotional self-regulation,~     particularly anxiety, anger, depression, and positive affect, through the treatment of~     alexithymia.~   "
4326|NCT03510273|"~     This is a prospective study to evaluate the short-term safety and acceptability of the Liger~     Medical thermal coagulation device for treatment of cervical precancerous lesions. Study~     results will inform the Honduras Ministry of Health regarding potential use of the Liger~     device for precancer treatment in Honduras and results may be of interest to other Latin~     American settings as well.~      The research will be conducted in the Tegucigalpa Region in Honduras in 4 health facilities~     in urban and peri-urban settings. Participants will be women ages 30-49 who meet the study~     eligibility criteria. HPV and VIA positive women who are eligible for ablative treatment will~     be offered thermal coagulation with the Liger instrument to treat their lesions and ask about~     acceptability of the treatment. At this visit, biopsies will also be taken. Women will then~     be followed-up at 1-month to evaluate short-term safety outcomes with a physical exam and~     receive their biopsy results. Depending on their biopsy results, they will be asked to return~     for repeat screening, referred for further treatment or asked to come back for a 12-month~     study visit. At the 12-month visit after treatment women will be followed up to evaluate cure~     rates.~      A second investigational device, Pocket Colposcope, will be used to take cervix photos at the~     first study visit with participant consent. The photos will be used to explore factors~     influencing treatment failure. De-identified photos and women's diagnosis information will~     also be shared with the device developers, Duke University, for the purposes of improving~     their device. Women may choose to opt out of having cervix photos taken and still participate~     in the treatment portion of the study.~   "
4327|NCT03510260|"~     · The target population for our study is women who present in their last clinic visit before~     delivery and are scheduled for an elective cesarean section. In that visit, the provider will~     notify the research team in order for the subject to be screened for the study. If the~     subject consents to participation, written informed consent will be obtained by~     person-to-person contact. The PI, study coordinator, or a collaborator will be responsible~     for the informed consent. After in-formed consent is obtained, the patient will be randomized~     to the following study groups:~      The control group will undergo regular consenting only.~      Study group I (e-confirmed consent only) will receive an electronic invitation to complete~     the consent process electronically and will proceed through the Confirmed Consent system~     prior to arrival to labor and delivery on day of surgery, which is the routine patient flow~     at this time. After completion of the survey, the subject will sign the regular paper consent~     for the procedure as standard in our institution.~      The study group II will undergo the same intervention as group II but the COMRADE survey~     questionnaire will be obtained by phone or in person after the completion of the paper~     consent form.~   "
4328|NCT03510247|"~     Rugby union is a high intensity, intermittent team sport which is played over 80 minutes.~     Players are divided into two main positional groups, forwards and backs, with backs covering~     a larger distance and completing more sprints and forwards partaking in more static~     exertions. With the game of rugby union getting progressively faster, body composition and~     power to weight ratio are key determinants. Due to the demands placed on these players it is~     essential that they are in optimal health continually, however, whilst the required physical~     attributes are well documented, this research will provide an insight into physiological and~     anthropometric changes that occur across two seasons.~      During this study subjects will be asked to attend the lab on 8 occasions over the course of~     two seasons (June 2018, September 2018, January 2019, April 2019, June 2019, September 2019,~     January 2020 and April 2020). During these visits the following tests will be completed; a~     peripheral Quantitative Computed Tomography (pQCT) scan of the bone mineral composition of~     the tibia and radius, total body composition via Dual Energy X-ray Absorptiometry (DXA),~     anterior-posterior spine bone mineral density to assess fracture risk via DXA, vertebral~     fracture risk via DXA. ~24ml of whole blood will be taken to determine serum 25(OH)D,~     albumin, calcium, zinc, total red blood cell count, lymphocytes, monocytes, carboxy-terminal~     collagen crosslinks (CTX) and amino-terminal propeptide (P1NP) concentrations. In June all~     players will complete a 6 minute run to determine fitness. Players will be expected to~     measure body weight and complete wellness questionnaires daily at the club and have skinfold~     measurements taken monthly. global positioning system (GPS) data will be collected during~     each training session and performance analysis will be utilised to determine the amount of~     contacts completed. Illness and injury occurrences will be recorded throughout the season.~   "
4329|NCT03510234|"~     To evaluate whether the use of the Argus II retinal prosthesis improves the confidence and~     self-esteem of patients with advanced retinopathy pigmentosa~   "
4330|NCT03510221|"~     Recent evidence suggests that there is a directly proportional relationship between diets~     with a high concentration of antioxidants and the reduction of blood pressure and the risk of~     cardiovascular events. However, there is a gap with regard to research on the effects of~     these diets on vascular function, especially in humans. The aim of this study was to evaluate~     the effect of antioxidant supplementation through the consumption of blueberry, cranberry and~     pomegranate extract capsules (1 of each per day), the effect of the autonomic balance in~     hypertensive and normotensive adults.~   "
4331|NCT03510208|"~     The phase I/II trial studies the side effects and best dose of panitumumab-IRDye800 in~     diagnosing participants with malignant glioma who undergo surgery. Panitumumab-IRDye800 can~     attach to tumor cells and make them more visible using a special camera during surgery, which~     may help surgeons better distinguish tumor cells from normal brain tissue and identify small~     tumors that cannot be seen using current imaging methods.~   "
4332|NCT03510195|"~     After completion of 5 years of medical school training, the next step of becoming a House~     Officer is said to be associated with high levels of stress. It has been associated with~     mental health problems amongst HOs and sometimes quitting the medical line altogether. In~     Malaysia, the number of HOs not completing housemanship training within the allocated time is~     slowly declining from 86.4% (2009) to 58.8% (2012). The dropout rate is said to be increasing~     yearly.~      This causes a lot of constraints on the HO, their family, sponsors, patients and also the~     country. Amongst the reason for stress is the feeling of incompetency or fear of making~     mistakes. Other work-related issues include workload, time management, financial, colleague~     and superior related issues.~      Medicorp is a company that specializes in training for junior doctors and has come up with a~     module to help medical graduates cope with these issues. The module is a 3-day-course named~     the HO Preparatory Course. It was initially the brainchild of the Islamic Medical Association~     of Malaysia (IMAM) but was later privatized to accommodate the demand and the running of the~     module and courses. The module has been re-evaluated through feedback of participants and~     trainers to cater to the needs and wants of the newly graduate; be it local or overseas.~      Therefore, the investigators would like to assess whether this intervention module is~     effective in addressing HO stress, therefore consequently reduce the risk of drop out and~     extension in HO training.~   "
4334|NCT03510169|"~     The NeoVest delivery device is a wearable vest/shell that surrounds the infant's abdomen. It~     was developed using serial body measurements of infants previously admitted to the St.~     Michael's Hospital NICU (REB #15-183). It gently pulls on the abdomen by applying negative~     pressure, thereby displacing the diaphragm. The materials used for the NeoVest are~     lightweight and suitable for the infants' sensitive skin.~      The AIM of the present study is to demonstrate the feasibility of applying negative pressure~     NIV, that is synchronized and proportional to the infant's respiratory demand. The~     preliminary data on feasibility can be used to apply for larger grants from the CIHR, for a~     study of the NeoVest in smaller premature infants.~   "
4335|NCT03510156|"~     Disruptive behaviors such as self-injury, aggression, and property destruction pose~     significant health-related issues to children diagnosed with fragile X syndrome (FXS),~     impacting the child's quality of life and causing significant distress to families.~      Access to appropriate treatment for families is severely limited by factors such as cost of~     care, shortages of qualified treatment providers, and geographic spread of children with FXS~     across the country. To address these potential issues, the effectiveness of administering a~     standardized function-based behavioral treatment for problem behaviors in FXS will be~     evaluated using telemedicine. The proposed study intervention therefore offers a tremendous~     step forward in clinical research both in the field of FXS and in the field of developmental~     disabilities more broadly, and thus will have a significant impact on public health.~   "
4336|NCT03510143|"~     This study is a randomized controlled study to investigate the effect of Polyglycolic Acid~     Mesh Sheet (NeoveilTM) on the thyroid cancer surgery.~   "
4337|NCT03510130|"~     Cesarean delivery rates have risen in the US in a dramatic fashion from less than 5% in the~     1960 to 32.7% by 2013 with stable rate around 32-33% in the last five years , cesarean~     delivery is associated with increased maternal morbidity and mortality, Labor arrest is the~     most common indication for cesarean delivery, Maternal position during the second stage of~     labor has been suggested to affect the risk of instrumental vaginal delivery. A Cochrane~     review of position in the second stage of labor in women without epidural showed a reduction~     in instrumental vaginal delivery in the upright group, although the quality of the included~     trials was reported to be generally poor, A Cochrane review of position in the second stage~     of labour for women with epidural analgesia was published in 2017, This review included~     trials that compared upright with recumbent positions and suggested no effect.~      No prior studies examined whether maternal legs movement during the second stage of labor has~     any effect on the rate of operative deliveries.~   "
4338|NCT03510117|"~     While MBI trials have reached a greater level of rigor (e.g., random assignment, matching on~     time, attention, teacher characteristics, non-specific factors) a significant gap still~     remains in mindfulness research: the lack of a comprehensive and standardized self-report~     measurement system. A precise, carefully constructed set of assessment tools based on a~     common measurement system are needed; where scores can be psychometrically linked to current~     legacy measures to better understand the existing body of mindfulness research. In this~     study, Creating and Optimizing Mindfulness Measures to Enhance and Normalize Clinical~     Evaluation (COMMENCE), the investigators will use Patient Reported Outcomes Measurement~     Information System (PROMIS) methodologies to construct improved self-report~     mindfulness-related measures. They will also use PROMIS-based PROsetta Stone linking methods~     to equate scores and create cross-walks between new mindfulness measures and existing ones.~   "
4339|NCT03510104|"~     This first-in-human open-label, dose escalation study is designed to evaluate the safety,~     tolerability, and PK of MRX-2843 in subjects with relapsed/refractory advanced and/or~     metastatic solid tumors.~   "
4340|NCT03510091|"~     Video-assisted counseling has been shown to improve consistency of counseling regarding a~     wide variety of health-care related issues. West Cancer Center has shown a significant~     increase in breast cancer susceptibility gene testing in ovarian cancer patients following~     video-assisted counseling compared to traditional provider-led counseling. This trial is~     designed to determine if video-assisted counseling can improve HPV vaccination rates by~     providing consistent counseling in a timely fashion.~   "
4341|NCT03510078|"~     Hyperglycemia is a common condition among hospitalized patients. The occurrence of severe~     hyperglycemia is associated with increased morbidity and mortality in several populations.~     Several trials assessed the benefits of aggressive versus conventional glucose control. These~     studies evaluated different patient populations, glucose targets and treatment protocols and~     as a result reported conflicting results. To date there are no clear guidelines regarding to~     the preferred glucose target range in hospitalized non-critically ill patients. The common~     practice is to maintain glucose level lower than 180 mg/dl however there are no evidence~     based regarding to the outcomes of hospitalized patients treated with intensive compared to~     conventional glycemic control. This prospective randomized controlled study will compare~     intensive vs. standard glycemic control in hospitalized non-critically ill patients.~      Within 24 hours of hospitalization in the internal medical or geriatric departments, patients~     who are expected to require hospitalization for at least three consecutive days will be~     randomly assigned into one of the two study groups - intensive with a target blood glucose~     range of 130 mg per deciliter or less, or conventional glucose control, with a target of~     130-180 mg per deciliter. The investigators defined the primary end point as a composite~     outcome of mortality in 30 days, severe hypoglycemia, severe infections within 30 days, CVA~     and cardiac ischemic events within 30 days.~   "
4342|NCT03510065|"~     Monocentric, non-interventional Post-Market Clinical Follow-Up (PMCF) Study on past~     implantations of the Prevision® prosthesis; the survival rate of the Prevision® prosthesis~     shall be evaluated and compared to literature results on comparable Revision stems.~   "
4343|NCT03510052|"~     Investigators will conduct a single-arm pre-post intervention pilot study in 46 older women~     with Fecal Incontinence (FI), also known as Accidental Bowel Leakage (ABL). FI symptoms and~     stool metabolites will be measured at baseline. Intervention with the Diet Modification~     Program (DMP) will be administered. FI symptoms and stool metabolites will be measured after~     6weeks of the intervention.~   "
4344|NCT03510039|"~     In a context of first hospitalization under the constraint of a relative in psychiatric~     emergencies:~        -  effect of an early intervention and a 6-month nursing follow-up on the anxious~          experience of third party persons~        -  effect of nursing support on family dynamics, on the durability of outpatient care and~          adherence~   "
4345|NCT03510026|"~     Electrosurgery is fundamental to the precise, fast and bloodless preparation of internal~     thoracic artery grafts in cardiac surgery. The PEAK PlasmaBlade is a monopolar~     electrosurgical device that uses pulsed radiofrequency energy to generate a plasma-mediated~     discharge along an insulated electrode, creating a cutting edge while the blade stays near~     body temperature. The aim of this study is to compare the histological samples, cardiac~     computed-tomography of graft patency, and clinical outcomes of patients after off-pump~     coronary artery bypass grafting with preparation of the internal thoracic arteries by a~     conventional electrosurgical device and the PlasmaBlade.~   "
4346|NCT03510013|"~     The investigators propose a new wash-in technique for sevoflurane low flow anesthesia with~     fresh gas flow of O2:N2O or O2:air 1:1 L/min with sevoflurane 8%.~      The objective of this study is to identify time to achieve alveolar concentration of~     sevoflurane at 1, 1.5, 2, 2.5, 3, and 3.5%~   "
4347|NCT03510000|"~     One of the challenges in the design of the artificial pancreas (AP) is preventing~     postprandial hyperglycemia. Beyond algorithmic solutions, one countermeasure to postprandial~     hyperglycemia that may enhance performance of the AP is the use of adjunctive-to-insulin~     medications such as those in the Sodium Glucose-Linked Transporter 2 inhibitor class. This~     study evaluates whether use of oral empagliflozin on the background of single-hormone AP can~     improve postprandial blood glucose control. The investigators will test this hypothesis in a~     cross-over trial design by comparing open-label empagliflozin versus placebo in the setting~     of AP on separate study days that involve carbohydrate counting, simple meal announcement and~     no meal announcement strategies.~   "
4348|NCT03509987|"~     The aim of the present study was to compare hemoglobin (Hb) levels determined by point of~     care testing HemaCue and arterial blood gas analyzer with an automated hematology analyzer in~     critically ill geriatric patients.Forty geriatric patients requiring intensive care treatment~     were included in the study. Arterial blood sample was analyzed using HemaCue~     (HbHemaCueArterial), blood gas analyzer (Techno Medica, Gastat1800 series) (HbBGA) and an~     automated hematology analyzer (Cell Dyne 3700 System, Abbot Laboratories)(HbLab) as a~     reference method. Capillary blood measurements were performed (HbHemaCueCapillary) by HemaCue~     at bedside.~   "
4349|NCT03509974|"~     To study the initial experience with implanting and fitting a new Bone Conduction system in~     pediatric patient population with conductive, mixed or single-sided deafness.~   "
4350|NCT03509961|"~     This study will evaluate the use of non- TBI (total body irradiation) conditioning for B-ALL~     patients with low risk of relapse as defined by absence of NGS-MRD (next generation~     sequencing minimal residual disease) before receiving a hematopoietic cell transplant (HCT).~     Patients diagnosed with B-ALL who are candidates for HCT will be screened by NGS-MRD on a~     test of bone marrow done before the HCT. Subjects who are pre-HCT NGS-MRD negative will be~     eligible to receive a non-TBI conditioning regimen as part of the treatment cohort of the~     study. Subjects who are pre-HCT NGS-MRD positive will be treated as per treating center~     standard and will be followed in an observational cohort (HCT center standard of care).~   "
4351|NCT03509948|"~     This will be an open-label, randomised, 2-treatment period, single-dose crossover study to~     determine the comparative bioavailability and renal elimination of cytisine following~     single-dose administration in healthy smokers under fed and fasted conditions.~   "
4352|NCT03509935|"~     The mortality and postoperative complications of high risk surgeries vary in the different~     series. The management of this group of patients in intensive care unit (ICU) is fundamental~     to improve these outcomes. The objective of this study will be to evaluate whether the use of~     bedside ultrasound has an impact on the management of this group of patients with a~     consequent reduction in the incidence of acute renal failure in ICU and, secondarily, the~     incidence of associated complications. All adult patients (≥ 18 years old) admitted to ICU at~     Hospital das Clinicas of UFMG in the immediate postoperative period of major surgery with~     indication of ICU monitoring will be included and randomly randomized to the control or~     intervention group. The control group will be conducted by the intensive care physicians in~     charge without the US, while the second group will be conducted based in US findings. The US~     protocol will consist of a pulmonary US in four windows in each hemithorax , qualitative~     assessment of contractility and variation of inferior vena cava diameter. The primary outcome~     will be the development of acute renal failure as measured by the KDIGO score. Secondary~     outcomes will be length of ICU and hospital stay, ICU and 28 days mortality, length spent in~     mechanical ventilation, accumulated water balance, noradrenaline and dobutamine dose. Serum~     and urinary biomarkers will also be evaluated. Key words: ultrasound, high-risk surgery,~     intensive care~   "
4353|NCT03509922|"~     This study is to evaluate the effect of sarpogrelate on blood viscosity after 24 weeks in~     patients with high blood viscosity.~   "
4354|NCT03509909|"~     Posttraumatic stress disorder (PTSD) is a major health problem for the nation's Veterans,~     leading to significant physical and mental health morbidity and mortality. Current~     empirically-supported interventions ameliorate symptoms but generally do not restore full~     functioning, so the development of alternative or complementary approaches is a critical~     need. Large numbers of Veterans are seeking out yoga as a part of their recovery plans, but~     there is no standardization of yoga protocols. Likely reflecting this heterogeneity, evidence~     of yoga's efficacy is highly variable. This project aims to address this problem by~     elucidating the mechanisms by which yoga impacts PTSD, thereby guiding the development of~     standards for yoga for PTSD. Ultimately, the goal of this research would be to contribute to~     integrative care planning, whereby multiple approaches can be applied in a synergistic manner~     to restore wellness for Veterans affected by PTSD.~   "
4355|NCT03509896|"~     Observational medical record review of newly diagnosed CML-CP participants in China~   "
4356|NCT03509883|"~     The purpose of this study is to evaluate the absorption of apixaban (BMS-562247) into the~     bloodstream of healthy volunteers, when administered as sprinkle capsules compared to~     tablets. Eligible participants will be randomly assigned to 1 of 2 treatment sequences and~     will receive a single oral dose of apixaban twice during the course of the study.~   "
4357|NCT03509870|"~     examine safety of topical application of single dose allogeneic bone marrow derived~     mesenchymal stromal cells to non-healing diabetic foot ulcers~   "
4893|NCT03502863|"~     Prospective, comparative, randomized, non-masked clinical study to compare the Opternative~     Vision Test with LogMAR VA testing utilizing trial lenses, to standard manual refraction~     using a Phoropter, and LogMAR VA testing, in accuracy of visual acuity measurement.~   "
4362|NCT03509805|"~     Excess weight or obesity is associated with an increased risk of health disorders: high blood~     pressure, diabetes, cardiovascular risks, dyslipidemia and sleep apneas. During pregnancy in~     obese women, the risk of preeclampsia increases by three and the risk of fetal death in utero~     by five. Snoring and Obstructive sleep apnea (OSA) may be associated with increased risk of~     adverse pregnancy outcomes, including maternal cardio pulmonary status, fetal heart rate and~     fetal acidosis-basis status by recurrent upper-airway obstruction, hypoventilation, and~     intermittent nocturnal hypoxia. Reports in pregnancy have identified in association with OSA~     and preeclampsia, intrauterine growth restriction and stillbirth.~      The prevalence of OSA among women is estimated to be 2-5%, but it remains underdiagnosed~     during pregnancy. In sleep apnea syndrome, a few data have shown better pregnancy and fetal~     outcome with the use continuous positive airway pressure (CPAP) therapy.~      the hypothesis is in obese pregnant women that there could be a significant association~     between sleep apnea syndrome and hypertensive disorders, preeclampsia and adverse fetal~     outcomes This is a prospective study of Women with a body mass index of 35 kg.m2 or greater.~     The aim of this study is to determinate the prevalence of sleep apnea syndrome in obese~     pregnant women and the benefit of CPAP on the maternal and fetal outcome.~   "
4363|NCT03509792|"~     This research study is designed to investigate the effects of a simple cognitive task (a~     memory cue following by playing the computer game Tetris) on intrusive memories~     (flashbacks) and other symptoms after a traumatic event. Patients presenting to a hospital~     emergency department soon after a traumatic event will be randomly allocated to either the~     simple cognitive task intervention or control. Participants will be followed up at one week~     and one month, and where possible 3 and 6 months. It is predicted that participants given the~     simple cognitive task intervention will develop fewer intrusive memories and less severe~     clinical symptoms than those who are not. This will inform the potential future development~     of a simple technique to prevent distressing psychological symptoms after a traumatic event.~     Implementation aspects in a new hospital context will also be explored. Patients use their~     smartphone for part of the intervention in the study.~   "
4364|NCT03509779|"~     The goal of the present research is to identify an EMT signature, associated with long~     disease-free survival after surgery, which might potentially lead to specific treatment~     recommendations, thanks to an integrated molecular approach, including tissue analysis at~     DNA, RNA and miR levels Fonctional analyses using lung cancer cell lines will subsequently be~     used to validate markers identified in tumor screenings.~   "
4365|NCT03509766|"~     The goal of this study is to compare ten current and readily available FDA approved allergy~     skin prick devices to determine the most sensitive and specific product and methods used for~     the diagnosis of allergic disease. The primary outcome will be to determine the analytical~     sensitivity and specificity of all ten skin prick devices by measuring wheal and flare~     response to histamine and control diluent in 1mm increments. Secondary outcomes include~     comparison of skin prick technique, optimum histamine concentration, patient comfort,~     reproducibility, and the comparability of high-resolution digital images.~   "
4366|NCT03509753|"~     This is a pilot trial testing enteral feeds that are high versus low in prebiotic fiber in 20~     critically ill adults. The long-term goal is to determine the efficacy of fiber for the~     prevention of pathogen colonization/infection in the ICU.~   "
4367|NCT03509740|"~     Patients presented with primary dysmenorrhea composed the study population. One gram~     paracetamol and 100 mg tramadol in 100 ml saline with a slow infusion were compared in~     ceasing dysmenorrhea in the emergency department~   "
4368|NCT03509727|"~     A diagnostic accuracy study investigating the accuracy of procalcitonin in diagnosing~     invasive bacterial infections in your infants.~   "
4369|NCT03509714|"~     Emotional Premenstrual Syndrome (PMS) affects millions of women worldwide. For Emotional PMS,~     including depression, anxiety, perceived stress and aggression, there are very few options.~     Recent observational data suggest that nutritional supplementation with oxaloacetate, a human~     energy metabolite, greatly reduced the symptoms of Emotional PMS. The aim of this study was~     to confirm these observations on the effects of oxaloacetate on Emotional PMS symptom~     severity within a controlled clinical trial setting.~   "
4370|NCT03509701|"~     Among patients with thunderclap headache who were admitted to the four participating~     hospitals, who has diffuse segmental vasoconstriction on CT angiography or MR angiography~     will be eligible for the study. Participants who meet the definition of RCVS will be enrolled~     as the case-patients and others will be enrolled as control-patients. The RCVS group will be~     defined when two or more neurologists agree by the clinical features and angiographic~     findings. The result of tests for varicella zoster virus titer will not be opened to~     neurologists until the end of the study. For case and control patients, tests for varicella~     zoster virus infection are (1) Pre-existing virological markers (ex. VZV-IgG, IgM, and VZV~     PCR in CSF or Skin lesion if present) (2) VZV-specific cell mediated immune response (CMI) at~     the time of admission and one month later (3) VZV in blood measured by quantitative test of~     viral load with real-time PCR and digital PCR for latent viral load (4) Quantitative test of~     viral load with real-time PCR in saliva at time of admission and one month later.~     Reactivation or infection of VZV of patients with RCVS and controls will be compared.~   "
4371|NCT03509688|"~     The purpose of this study is to use entecavir combined with other drug such as resveratrol~     and thymosin to treat patients with hepatitis B, which may provide a novel therapy target~     hepatitis B.~   "
4391|NCT03509428|"~     Trial Phase: Phase III: A multi-centre efficacy pragmatic factorial design randomised~     controlled trial with patient informed development and process evaluation~      Indication: Patients undergoing major electively resectable intra - cavity cancer surgery~     with or without neoadjuvant cancer treatments (including chemotherapy (NAC),~     chemoradiotherapy (CRT), or immunotherapy).~      Objective: To investigate the efficacy of a community based Structured Responsive~     Exercise-training Programme (SRETP) ± psychological support on surgical outcome by reducing~     postoperative length of stay (LOS) and complications.~      Secondary Objective:~      To investigate the efficacy of a community based Structured Responsive Exercise-training~     Programme (SRETP) ± psychological support to improve disease-free overall survival.~     Cardiopulmonary Exercise test (CPET) variables, physical activity, morbidity, radiological~     markers of sarcopenia, toxicity, tumour down-staging, tumour regression, disability adjusted~     survival (WHODAS) overall survival and quality of life (QoL).~   "
4372|NCT03509675|"~     Oral lichen planus (OLP) is a common chronic autoimmune disease associated with cell-mediated~     immunological dysfunction. Symptomatic OLP is painful and complete healing is rare. Current~     treatments for lichen planus and lichenoid mucositis are usually directed towards reducing~     the symptoms.~      This double-blinded cross-over placebo-controlled clinical trial is designed to measure the~     effectiveness of NSAID on reducing pain associated with Oral Lichen Planus and Oral Lichenoid~     Lesions.~      Potential subjects will be screened through the Oral Medicine clinic registry at the~     University of Washington. The topical suspension of topical NSAID 100 mg per 5 ml~     concentration ibuprofen with the same ingredients of over the counter children's ibuprofen~     will be compound will be compounded by a drug service. Another placebo suspension will also~     be compounded with the same taste but without the active ingredient. After obtaining written~     consent from the patients regarding their participation in the research, subjects will~     receive a research packet with relevant data forms, the consent form two bottles; each bottle~     with an individual code number. One will have the active ingredient and the other will be the~     placebo. The coding list will be with one of the committee members.~      Subjects will be asked to record their baseline of spontaneous pain on a horizontal 10 cm,~     visual analog scale (VAS) before commencing using use of the provided rinses. If subjects~     were already on an active treatment at the time of enrollment, they will be asked to~     discontinue for 7 days for a washout period before starting the research study.~      All subjects will be instructed to use the first suspension 4 times a day for 7 days. After~     every application of the rinse, they will be asked to check a box to record the use of the~     rinse. Instructions will include to rinse with 5ml of the suspension for 1 minute without~     swallowing, then expectorate. Patients will be instructed to not to eat or drink for the~     following 20 minutes after the application of the drug. At the end of day 4 and day 7,~     subjects will be asked to record their spontaneous pain level on a 0-10 VAS. After the first~     week, the subject will discontinue any treatment for 7 days (wash-out) before starting the~     second suspension.~      All participants will be instructed to use the second suspension 4 times a day for 7 days.~     After every application of the rinse, they will be asked to check a box to record the use of~     the rinse. Instructions will include to rinse with 5ml of the suspension for 1 minute without~     swallowing, then expectorate. Patients will be instructed to not to eat or drink for the~     following 20 minutes after the application of the drug. Before using the second rinse and at~     the end of day 4 and day 7 of the third week, subjects will be asked to record their~     spontaneous pain level on a 0-10 VAS.~      Participants will be contacted initially after the first day of the intervention to discuss~     any concerns or questions. Every week, reminder phone calls will be made to the subjects to~     fill out the forms from the investigator and to check for any side effects from the~     intervention.~      Both the patient and the investigator will be blinded for the content of each bottle.~   "
4373|NCT03509662|"~     Only half of the patients suffering from cardiac arrest arrive at the hospital alive. Of~     these survivors, more than 50% will still die or remain severely disabled. During cardiac~     arrest ischemia causes damage to the vital organs, especially the brain. When with return of~     spontaneous circulation oxygen is re-offered to the ischemic organs, massive amounts of~     reactive oxygen species (ROS) are produced. These ROS can further increase the damage to the~     myocardium and brain (reperfusion injury). Vitamin C is the primary circulating antioxidant.~     It scavenges free radicals and reduces the production of ROS. In a recent study we~     demonstrated that vitamin C plasma levels are deficient in ~60% of the patients after cardiac~     arrest, probably due to massive consumption. Vitamin C deficiency reduces the protection~     against oxidative stress. Intravenous supplementation is needed to restore deficiency and the~     antioxidative effect of vitamin C is much more potent if it is administered in a~     supraphysiological dose (≥ 3 g per day). Its strong antioxidative effect may reduce damage to~     the circulation and to brain, heart and other organs. Beneficial effects of high dose i.v.~     vitamin C after cardiac arrest have been demonstrated in preclinical studies, but not in~     patients.~      The investigators hypothesize that vitamin C can reduce organ damage, especially cerebral~     injury, if administered for a short period as a high i.v. dose during the very early phase of~     reperfusion after cardiac arrest.~      Objectives:~        -  To determine whether an early high dose i.v. vitamin C can improve organ function,~          especially neurological outcome, in patients after cardiac arrest~        -  To explore the optimal dosing regimen for high dose i.v. vitamin C~        -  To investigate in vitro the difference in effect of plasma obtained from post cardiac~          arrest patients treated with placebo, 3 gr/day or 10 gr/day vitamin C on endothelial~          cell viability and underlying oxidative pathways.~   "
4374|NCT03509649|"~     Determine effects of perceptions and expectations on experience of cervical spine~     manipulation~   "
4375|NCT03509636|"~     This is a multicenter， open-label study to evluate the efficacy and safety of a novel PARP~     1/2 inhibitor fluzoparib （SHR-3162）in BRCA1/2-mutant Relapsed Ovarian Cancer.~   "
4376|NCT03509623|"~     This study aims to evaluate coagulation parameters in treatment naive patients with~     neovascular age-related macular degeneration (AMD). Treatment naive patients with neovascular~     AMD, scheduled to undergo treatment with intravitreal injections of aflibercept will be~     enrolled in the study. Blood samples will be collected before the first intravitreal~     injection and at 7 and 30 days after aflibercept administration.~   "
4377|NCT03509610|"~     Sugar is perceived negatively, leading to government taxation and targets to reduce~     consumption. These actions have been taken based on the limited evidence that high-sugar~     diets are associated with greater total energy intake. However, energy intake comprises just~     one half of the energy balance equation (e.g. balance = intake - expenditure). Without~     considering energy expenditure, it is impossible to understand the effects of sugar on~     health. Sugar, and perhaps total carbohydrate intake, may be important for energy balance -~     perhaps by stimulating increased energy expenditure.~      Understanding dietary regulators of energy balance is more important than ever before,~     because diseases like obesity are a consequence of energy surplus (i.e. energy intake >~     energy expenditure). No studies have investigated a causal role of dietary sugar or~     carbohydrate on energy balance. The proposed research will seek to understand the acute (e.g.~     24-hour) responses to manipulating dietary carbohydrate and sugar content on energy balance~     and health.~      This research will contribute to enabling individuals to make informed dietary choices about~     carbohydrate and sugar consumption.~      To achieve this, healthy non-obese adults will be recruited to a randomised crossover study.~     Measures of energy intake, energy expenditure, metabolic health, appetite, food preference,~     and gut microbiota will be taken. All laboratory trials will take place at the University of~     Bath.~      Three diets will be investigated:~        1. Control - reflecting the composition of a typical European diet~        2. Low sugar - the same composition of a typical European diet but with <5% energy intake~          from sugar~        3. Low carbohydrate - low carbohydrate diet with <5% energy intake from sugar and <8%~          energy intake from carbohydrate, replacing carbohydrate energy with fat~      The study will consist of a 3-day lead-in period with the control diet followed by one trial~     day with each diet.~   "
4378|NCT03509597|"~     This study evaluates the brain correlates of Cognitive Training and Aerobic Exercise in~     schizophrenia. A third of participants will receive Cognitive Training plus Standard Care for~     schizophrenia. Another third of participants will receive Aerobic Exercise Training plus~     Standard Care for schizophrenia. A control group will of participants will receive Standard~     Care plus Occupational Activities for the same duration and frequency as the experimental~     groups.~   "
4379|NCT03509584|"~     Nivolumab is superior to docetaxel monotherapy as second line treatment in advanced stage~     non-small cell lung cancer (NSCLC) patients. However, the long term survival advantage seems~     to be limited to a 20% proportion of treated patients. To date, no definitive biomarker,~     including tumor cells or infiltrative cells PD-L1 expression, has been demonstrated to~     predict nivolumab (or other PD1 or PD-L1 inhibitors) efficacy. Ipilimumab has also suggested~     efficacy in the same patient population. Finally, the addition of ipilimumab to nivolumab has~     a suggested better efficacy over nivolumab alone in advanced stage NSCLC patients with an~     acceptable safety profile.~      In parallel, hypo-fractionated radiotherapy alone has been suggested to elicit the immune~     system activity as demonstrated by the occurrence of an abscopal effect. Some case reports in~     melanoma but also lung cancer patients reinforced this hypothesis.~      Furthermore, preclinical and clinical data suggest that radiation may have a synergistic~     effect with antibodies targeting the immune checkpoints (PD1, PD-L1, CTLA4) and improve~     antitumor efficacy. Moreover, it has been shown that fractionated radiotherapy delivered in~     combination with aPD-1 or aPD-L1 mAbs is able to generate efficacious CD8þ T-cell responses~     that will in turn improve local tumor control, long-term survival, and protection against~     tumor rechallenge.~      Therefore, the combination of single fraction or hypo-fractionated radiotherapy with the anti~     PD1 nivolumab and/or the anti CTLA4 ipilimumab warrants further investigation. However, a~     large number of doses, sequences and schedules remain possible. In order to select the best~     combination, a mathematical modeling of immunotherapy in cancer and its synergy with~     radiotherapy has been set up. This work provides with mathematical formulas to link the drug~     serum concentrations of nivolumab and ipilimumab, and the dose of radiation therapy, to the~     immune response. In silico, the single and three fractions schedule have been found to have~     the same efficacy while activation of the immune response seems to be better using a~     hypo-fractionated (less than 6 fractions) radiotherapy in vivo.~   "
4380|NCT03509571|"~     The purpose of this project is to determine if 8 weeks of ketogenic (KD, high-fat) diet vs.~     standard diet (SD) significantly improves motor and sensory function, gut function, and~     functional independence in patients with complete SCI.~   "
8782|NCT03451929|"~     Prospective multicenter follow-up study of 10 years. Cohort established between 2005-2007~     with stratified random sample of general population older than 20 years (Census 2001), N=~     2746 subjects.~   "
4381|NCT03509558|"~     Growing evidence indicates that electrical spinal cord stimulation improves motor functions~     both immediately and over the long term via modulating the excitability of spinal circuitry~     in patients with spinal cord injury. Recently, a novel, non-invasive, well-tolerated and~     painless lumbosacral transcutaneous electrical stimulation strategy was demonstrated to be~     effective for improving lower limb motor function in participants with spinal cord injury.~     Our current project, cervical transcutaneous electrical stimulation and intensive exercise~     for arms and hands, is also revealing significant improvement of upper extremity function.~     Additionally, the subject and caregiver noted that stair climbing ability has been~     substantially enhanced starting from the first week of cervical stimulation treatment and~     continues to date.~      This study is a prospective efficacy trial of combined transcutaneous cervical and~     lumbosacral electrical stimulation with intensive physical therapy for improving locomotion~     in people with incomplete tetraplegia and paraplegia.~      This experiment design consists of two to four phase intervention program including one-month~     physical therapy (PT) only (A) followed by one-month spinal stimulation with PT (B). Between~     each intervention, washout periods of up to one-month may be used to determine any~     after-effect of the interventions. The AB or BA interventions will be repeated if the~     functional improvement does not reach a plateau during the first two month of interventions.~     Sessions will last up to 2 hours/day, 2 to 5 days/week for each arm. Both immediate and~     lasting improvements in lower extremity function and autonomic function via transcutaneous~     spinal stimulation and intensive physical therapy will be evaluated.~   "
4382|NCT03509545|"~     To compare the effects of 40 mg once-daily Torsemide ER to 40 mg twice daily Furosemide on~     24-hour sodium excretion.~   "
4383|NCT03509532|"~     Study Title A post market registry of Abluminus® sirolimus eluting coronary stent system for~     percutaneous intervention in patients with diabetes mellitus Purpose The purpose of this~     registry is to prospectively capture clinical data of ABLUMINUS® sirolimus eluting stent in~     patients with Diabetes Mellitus.~      Investigational Device ABLUMINUS® sirolimus eluting stent consists of four components; a bare~     metal stent (BMS), a delivery system, the bio absorbable polymer delivery matrix and~     Abluminal surface coating on stent and parts of balloon in Pre-crimped condition the~     anti-proliferative drug, Sirolimus.~      Study Design Prospective, Observational, Multi‐center registry Estimated Enrolment 1000~     patients~      End points Primary Endpoints:~      Target Lesion Failure that is composite of cardiac death, target-vessel myocardial~     infarction, and clinically indicated target lesion revascularisation within 12 months.~      Components of the primary end point are defined as follows:~        -  Cardiac Death: any death due to immediate cardiac cause, deaths related to the~          procedure, unwitnessed death, and death of unknown cause.~        -  Target Vessel Myocardial infarction: categorised according to the Minnesota~          electrocardiographic criteria (Q-wave and non-Q-wave). Spontaneous myocardial infarction~          was defined as a typical rise and fall of creatinine kinase-MB fraction or troponin in~          the presence of at least one of several conditions: ischaemic symptoms, new pathological~          Q waves, ischaemic electrocardiographic changes, or pathological evidence of acute~          myocardial infarction. Peri-procedural myocardial infarction was defined as an increase~          in creatinine kinase to more than twice the normal value with increased values of~          confirmatory biomarkers (creatinine kinase-MB fraction or troponin higher than usual).~          Target-vessel-related myocardial infarction was one related to the target vessel or that~          could not be clearly related to another vessel.~        -  Target Lesion Revascularisation: any repeat percutaneous or surgical intervention due to~          a stenosis or occlusion within the device of the index procedure.~      Secondary Endpoints~        -  Stent thrombosis [Time Frame: 1 month, 12 months, yearly]. Definite and probable stent~          thrombosis according to ARC definitions;~        -  Cardiac death [Time Frame: 1 month, 12 months, yearly]~        -  Target Vessel Myocardial infarction [Time Frame: 1 month, 12 months, yearly]~        -  Target Lesion Revascularisation [Time Frame: 1 month, 12 months, yearly]~        -  Device Success at 24 hours~        -  Lesion Success at 24 hours~        -  Procedural Success at 24 hours Eligibility Eligible Age: 18 Years and older. Eligible~          Genders: Both. Inclusion Criteria~        -  The patient must be at least 18 years of age.~        -  Diabetic patient having clinical evidence of myocardial ischemia (e.g., stable or~          unstable angina, silent ischemia or positive functional study; acute coronary syndromes~          will be considered).~        -  The patient is an acceptable candidate for percutaneous trans-luminal coronary~          angioplasty (PTCA) stenting and emergent coronary artery bypass graft (CABG) surgery.~        -  Culprit de novo lesion in a native coronary artery with significant stenosis (>50% by~          visual estimate) eligible for stent implantation (no limitation on the number of treated~          lesions, vessel and lesion length);~        -  Patients included are those for whom the physician has already considered worthwhile the~          use of Abluminus Stent according to the indications provided by the IFU;~        -  Patient provides written informed consent;~        -  Patient agrees to all required follow-up procedures and visits. Exclusion Criteria • The~          patient has a known hypersensitivity or contraindication to any of the following~          medications:Heparin, Aspirin, Both Clopidogrel and TIclopidine, Sirolimus, paclitaxel,~          ABT 578Stainless steel, Cobalt, biodegradable PLLA polymer.~        -  Patients with hypersensitivity to contrast media who cannot be treated with adequate~          prophylaxis.~        -  Female of childbearing potential, unless a recent pregnancy test is negative, who~          possibly plan to become pregnant any time after enrolment into this study.~        -  Patients who are actively participating in another drug or device investigational study,~          which have not completed the primary endpoint follow-up period.~        -  History of bleeding diathesis or known coagulopathy (including heparin-induced~          thrombocytopenia), or will refuse blood transfusions~        -  Previous coronary intervention on target vessel.~        -  Non-cardiac co-morbid conditions with life expectancy <1 year or that may result in~          protocol non-compliance (per site investigator's medical judgment).~        -  Lesions not allowing a complete balloon inflation or stent deployment. Clinical Follow~          up At Discharge, 1 month, 6 months, 12 months, yearly.~   "
4384|NCT03509519|"~     The purpose of this placebo controlled clinical trial is to examine the effects of of~     neuromuscular electrical stimulation (NMES) training on physical activity, muscle function,~     self-efficacy, and blood markers [e.g., brain-derived neurotrophic factor (BDNF)] in older~     adults.~      It is hypothesized that 4-weeks of NMES will increase 1) physical activity, 2) muscle~     function, 3) self-efficacy, and 4) BDNF in older adults.~      Sarcopenia is a destructive progressive cycle of impaired physical function resulting in loss~     of muscle mass, strength, and self-confidence in ability to perform physical activities,~     compounded by difficulty walking and ultimately reduced physical activity levels for many~     older adults. Neuromuscular electrical stimulation (NMES) is a common therapeutic modality~     used to create involuntary muscle contractions as a means to increase muscle strength, and~     may be an effective treatment for improving muscle function and physical activity levels in~     older adults with sarcopenia. Thus, it is critical to explore viable and effective~     alternative therapies to increase physical activity. The goal of the investigators' is to~     determine the effectiveness of neuromuscular electrical stimulation (NMES) at increasing~     physical activity and related biological, psychological, and muscle function factors. This~     placebo controlled clinical trial will use a pre-test - post-test randomized experimental~     design.~   "
4385|NCT03509506|"~     This study was designed to determine the potential benefits that individuals with heart~     failure (HF) could experience from using a mobile application.~   "
4386|NCT03509493|"~     FibriCheck is a Conformité Européenne (CE)-approved (class IIa) medically diagnostic~     application that allows for heart rhythm registrations based on an optical signal captured~     via the smartphone camera. FibriCheck is only available on prescription causing the physician~     to stay in the 'driving seat' and the application distribution to be traced.~      By using FibriCheck, a medically validated smartphone application, daily rhythm measurements~     can be performed using only the smartphone of the patient. This allows for the heart rhythm~     to be registered and monitored in a home environment and the data to be automatically sent to~     the physician. This enables the implementation of FibriCheck in two types of scenarios:~        -  Scenario 1: the follow-up of patients with high risk parameters for AF development for~          primary and secondary prevention, whereby detection of AF will result in therapeutic~          intervention~        -  Scenario 2: the realisation of monitoring of the heart rhythm of patients post~          intervention in a home environment~   "
4387|NCT03509480|"~     For benign curetted tumor defects, ultraporous beta-tricalcium phosphate (TCP) synthetic~     graft material (Vitoss; Orthovita, Inc., now Stryker, Inc.) persists for a year or longer in~     some cases even when BMA is added. What is not known is whether the addition to TCP of~     calcium sulfate (CS), which by itself has a more rapid resorption profile, will lead to more~     rapid resorption and incorporation of the composite graft material.~   "
4388|NCT03509467|"~     The purpose of this study is to examine how different messages about risk of melanoma can~     impact the way people protect themselves against developing these diseases.~   "
4389|NCT03509454|"~     Background: Today diabetic nephropathy is a frequent, and the most lethal and costly~     complication of diabetes. Although treating blood pressure with agents blocking renin~     angiotensin system has improved outcome, the prognosis is still poor and no new interventions~     have been successful during the past decade. There is an urgent need for discovery of new~     pathways behind the development and progression of diabetic nephropathy as well as of~     biomarkers which can identify subjects at risk of developing adverse events. Objective: By~     using a multidimensional 'omics' approach, we aim to search for novel proteins, metabolites~     and pathways that will point to the putative new mechanisms which underlie the early renal~     decline.~      Design: Cross-sectional study, with long-term register-based follow-up. Study population: 160~     patients with type 1 diabetes recruited from Steno Diabetes Center Copenhagen stratified~     based on stage of diabetic kidney disease, and 50 healthy non-diabetic controls. Endpoints:~     Primary endpoint: Glycocalyx thickness, assessed as perfused boundary region. Secondary~     endpoints: Gut microbiome characterisation and markers of gastrointestinal inflammation,~     autonomic and periphery neuropathy, urine and plasma Flow Cytometry Analysis (FACS),~     metabolomics and proteomics in plasma and urine, and other potential biomarkers.~   "
4390|NCT03509441|"~     The purpose of this study is to evaluate the relationship between insulin resistance (IR) and~     myocardial tissue abnormalities. The study will focus on a patient population, South Asians,~     with a high prevalence of IR.~   "
4392|NCT03509415|"~     We propose to undertake a study to determine the diagnostic utility of using RCM for the~     diagnosis of Basal Cell Carcinoma (BCC) in a tertiary referral centre as outlined by the~     recent NICE report (Nov 2015). This will allow an assessment of the potential to avoid~     diagnostic biopsy within the treatment pathway.~   "
4396|NCT03509363|"~     This is a pilot study and a randomized, controlled, assessor-blinded clinical trial for~     patients who will complete the inpatient Stroke Rehabilitation Program in the Department of~     Medical and Geriatrics of Tai Po Hospital and Shatin Hospital from June 2018 to March 2019.~     The objective of the study is to compare the effectiveness of video-guided exercise program~     and standard paperbased home exercise program on adherence of exercise, self-efficacy and~     improving functional outcomes in patients with stroke within 3-month follow-up.~   "
4397|NCT03509350|"~     The VItamin C, Thiamine And Steroids in Sepsis (VICTAS) Study is a double-blind,~     placebo-controlled, adaptive randomized clinical trial designed to investigate the efficacy~     of the combined use of vitamin C, thiamine and corticosteroids versus indistinguishable~     placebos for patients with sepsis. The objective of this study is to demonstrate the efficacy~     of combination therapy using vitamin C, thiamine and corticosteroids in reducing mortality~     and improving organ function in critically ill patients with sepsis.~   "
4398|NCT03509337|"~     A single-center, observational, prospective, single cohort study with before-after design.~     Evaluation by shear-wave elastography, measured in kilopascals (KPa), of the muscle, tendon~     and cubital nerve, before and after the maneuver of putting in tension of the ulnar nerve.~   "
4399|NCT03509324|"~     The purpose of this study is to investigate and evaluate the significance of intravenous~     glucose tolerance test in assessment of β-cell function improvement after short course of~     intensive insulin therapy, trying to illustrate the relationship between fasting plasma~     glucose and acute insulin release under different stage of type 2 diabetes with poor glycemic~     control.~   "
4400|NCT03509311|"~     The primary aim of the study is to evaluate the physical activity level in patients with~     asthma. The secondary aims of the study are assesment of maximal and functional exercise~     capacity, respiratory functions, respiratory muscle strength and endurance, peripheral muscle~     strength, depression and anxiety levels, disease specific and respiratory quality of life,~     sleep and coughing associated quality of life, asthma self-management knowledge level and~     fatigue severity in patients with asthma.~   "
4401|NCT03509298|"~     This is a phase II Randomized comparison clinical trial of activated CIK armed with~     anti-CD3-MUC1 bispecific antibody for advanced pancreatic cancer. And the aim of this~     research is to study the clinical efficacy and safety of activated CIK armed with~     anti-CD3-MUC1 bispecific antibody for pancreatic cancer.~   "
4402|NCT03509285|"~     This randomized, single-dose, placebo- and active-controlled, crossover study will evaluate~     the abuse liability potential of cenobamate in recreational drug users with sedative drug use~     experience.~      In the Qualification phase, subjects will receive a single dose of either alprazolam or~     placebo in a crossover design, with a wash-out period of at least 24 hours between~     treatments. Subjects who are clearly able to distinguish the positive control from placebo~     will be enrolled in the Treatment phase and will be randomized to single oral doses of~     cenobamate (2 dose levels), alprazolam (2 dose levels), and placebo in a double-blind,~     double-dummy, 5-way crossover design. Washout-periods between the 5 treatment periods in the~     Treatment phase will be at least 16 days.~   "
4403|NCT03509272|"~     Background:~      Multiple adaptations at the cardiovascular system occurs during pregnancy. In the pregnancy~     condition pre-eclampsia (PE), this adaptations are abnormal. Five to eight percent of all~     pregnant women worldwide will develop PE.~      PE is a pregnancy condition which is characterized with a high blood pressure (>140/90 mm Hg)~     and the occurrence of proteinuria (>3g/dl/24h) after 20 weeks of gestation. When untreated,~     this condition can have severe complications for both mother and child. It's important to~     monitor women with a high risk for developing PE for an early detection and treatment of this~     condition.~      For this reason, a multicenter study is set up with the following applications:~        1. NICCOMO and Maternal Venous Doppler Echography: impedance cardiograph and an echography~          of the heart and veins.~        2. Maltron: bio-electronic impedance analyze~        3. Remote monitoring of the high risk patients to become a more intensive follow-up~      Number of inclusions: 1000 pregnant women from the prenatal consultations of eight different~     hospitals:~   "
4404|NCT03509259|"~     This study is a cross-sectional study to evaluate the relationship between coronary calcium~     score and clinical parameters of asthma such as onset of disease, lung function parameter and~     airway inflammation parameter (sputum eosinophil or FeNO) in Korean elderly asthma and~     asthma-chronic obstructive pulmonary disease(COPD) overlap patients~   "
4405|NCT03509246|"~     This study is a phase II clinical trial to evaluate the safety and efficacy of Bortezomib~     plus Pegylated liposomal doxorubicin combination therapy in a histologic type of high-grade~     serous carcinoma without BRCA mutation among patients with platinum-resistant recurrent~     ovarian cancer. Subjects are dosed with Bortezomib and PLD for a maximum of 6 cycles of 4~     weeks. The response rate is evaluated with CT according to RECIST criteria ver 1.1. The~     efficacy and safety of the drug are assessed at the time of recurrence, at the time of death,~     or after 24 months after the end of the study drug administration.~   "
4406|NCT03509233|"~     It is the aim of the study to evaluate the efficiency of One stage full mouth disinfection~     according to the original protocol (Quirynen et al. 1995) in comparison to other approaches~     considering different scaling strategies and different disinfection concepts. Therefore, a~     multicenter randomized control treatment will be performed. In total, 204 patients with~     chronic periodontitis shall be allocated to the following treatment concepts. Group A:~     quadrant scaling with weekly intervals (Q-SRP; N = 51); Group B: full mouth scaling (FMS; N =~     51); Group C: full mouth disinfection (FMD; N = 51); Group D: full mouth disinfection with~     subgingival glycine air polishing using erythritol powder (FMDP; N = 51). Evaluation of~     periodontopathic parameters and periodontal pathogens at baseline, 3 months and 6 months~     shall give evidence about the benefits of concept and the single components of FMD.~   "
4407|NCT03509220|"~     This study evaluates the efficacy, safety and tolerability of PBK-1701TC for bowel cleansing~     before colonoscopy. Half the participants will receive PBK-1701TC and while the other will~     receive standard oral preparation.~   "
4408|NCT03509207|"~     Uterine sarcomas are rare tumors with a poor prognosis.~      The main purpose of this phase II proof-of-principle- pilot study is to test the efficacy of~     the hydroxamic acid-based Histone deacetylase inhibitor (HDACI) Vorinostat (SAHA) as~     monotherapy in patients with HDAC-positive, progressive, metastatic uterine sarcomas and~     mixed epithelial and mesenchymal tumors after prior anti-proliferative therapy.~   "
4409|NCT03509194|"~     The aim of this study is to validate and develop a new diagnostic and prognostic approach for~     assessment of liver function in children and adolescents with acute liver failure and chronic~     liver insufficiency.~      A carefully selected panel of functional and genomic tests along with diagnostic imaging and~     analysis of the microbiota will be performed in children and adolescents with acute liver~     failure and chronic liver insufficiency at Rigshospitalet. The tests will be performed in a~     serial manner in order to detect changes in outcomes. The study is an unblinded descriptive~     study, and approximately 20 patients with acute liver failure and 100 patients with chronic~     liver disease will be included in the project.~      This study will be the first of it's kind worldwide. The investigators expect the study to~     improve future diagnostic and prognostic accuracy and help the clinicians in identifying~     those patients in which the liver will regenerate itself, from those patients in which a~     liver transplantation will be lifesaving. Furthermore this study aims to help the clinicians~     in defining the optimal time for pediatric liver transplant in a narrow window of~     opportunity.~   "
4410|NCT03509181|"~     Approximately 4.1% of the adult US population meets the criteria for SMI, a mental disorder~     associated with significant functional impairment. Even when effective, pharmacologic and~     psychological treatments often leave individuals with SMI with residual symptoms, impairment,~     and at risk for re-hospitalization and suicide. The month following hospitalization is a~     particularly risky time; thus, augmentation treatments that can speed up improvement during~     brief hospital stays, as well as provide a bridge to outpatient care are urgently needed.~     Thus, the investigators propose to develop an augmentation to psychiatric hospital care~     (called I-Change) that can be continued at home following discharge. I-Change targets~     interpretation bias, the tendency to resolve ambiguous situations negatively. Interpretation~     bias is a well-established cognitive vulnerability for psychopathology and is associated with~     poor emotion regulation, rumination, symptom severity, and suicidal ideation. For example, in~     a psychiatric hospital sample, interpretation bias upon admission accounted for 28% of the~     variance in treatment response, and predicted suicidal ideation at discharge, controlling for~     ideation at admission. Although some existing treatments target this mechanism, most notably~     Cognitive Behavioral Therapy (CBT), they require individuals to be able to recognize their~     automatic interpretations and use complex techniques to reappraise them. Individuals with SMI~     who are experiencing symptoms acute enough to require hospitalization are often treatment~     refractory and may experience particular difficulty applying these techniques. It is~     therefore critical to more efficiently and effectively engage this target. Over the past 14~     years, the Principal Investigator has developed and validated a training task that utilizes~     repetition and feedback to reinforce a healthier interpretive style. The computer-delivered~     version of the task was acceptable to an SMI population and led to better treatment response~     than a placebo task in patients who exhibited interpretation bias at baseline. The~     investigators seek to develop this task into a personalized smart-phone delivered~     intervention. The investigators will harness smart-phone technology to enhance skill~     acquisition and generalization by improving user engagement and prompting participants to~     complete a session at set times to ensure adequate dosage and spacing of sessions. The~     investigators will conduct an open trial (n = 16) and a randomized controlled trial (n = 64)~     to confirm target engagement (improvement in interpretation bias), evaluate the feasibility~     and acceptability of delivering I-Change during and following discharge from a partial~     hospital, and examine clinical outcomes (global improvement, functioning) related to changes~     in interpretation. I-Change is expected to shift interpretation bias, be acceptable to~     patients with SMI, and lead to greater global improvement compared to a Symptom Tracking~     control. Results will support a fully-powered effectiveness trial.~   "
4411|NCT03509168|"~     Open myomectomy remains the principal treatment for symptomatic fibroids in sub-Saharan~     countries irrespective of fertility desires. This however has got to be balanced against~     potential risks such as profuse hemorrhage; blood loss at open myomectomy remains dreary with~     the use of various pharmacologic agents yielding inconclusive results. This trial is aimed at~     exploring the benefit of preoperative use of a readily available uterotonic, Misoprostol in~     reduction of intraoperative blood loss during open myomectomy with the Null hypothesis~     stating: there is no difference in mean blood loss during open myomectomy whether one~     preoperatively inserts a single dose of 400mcg vaginal misoprostol or not.~      Alternate hypothesis: single dose 400mcg vaginal Misoprostol given 60 minutes preoperatively~     during open myomectomy reduces intra-operative blood loss by at least 20% as measured by~     surgical mops and suction.~      Participants from two referral hospitals in Uganda with symptomatic fibroids and scheduled~     for open myomectomy will be recruited. 48 women that meet the inclusion criteria and have~     none of the exclusion criteria and provide signed informed consent will be enrolled. The~     screening will be done on the gynecological wards and patients will be randomized to either~     the control or interventional arm by means of sealed, sequentially numbered opaque envelopes~     containing computer-generated random numbers. Blinding will affect theatre team and patients.~     Primary (blood loss as estimated by surgical mops and suction) and secondary endpoints (e.g.~     postoperative drop in Hb) will be calculated. Data analysis: Data will be analyzed on an~     intention-to-treat basis. Analysis will be done using STATA software 14.0. This will include~     descriptive statistics for measures of central tendency and dispersion. Student t-test and~     Mann Whitney U test will be used for mean blood loss. Stratification for age, parity,~     complaints, total fibroid mass and usage of other intraoperative blood-loss techniques will~     be analyzed. categorical data to be analyzed by coefficients.~      Results of this study are meant to better inform clinicians about the use of misoprostol for~     this role and possibly include it in the management protocols for open myomectomy in~     Sub-Saharan countries where burden of blood products is strained.~   "
4412|NCT03509155|"~     Assessing program efficacy of under five food supplementation (PMT Biscuits) is needed after~     the first 6 months of exclusive breastfeeding, children were introduced to liquid and~     semi-solid food. In this phase of food introduction, children ability to accept food~     supplementation program was still questionable and the efficacy needs to be assessed.~      Another aspect that needed to be evaluated is assessing the efficacy of food supplementation~     to improve the nutritional status of wasting children in multiple cities to describe~     Indonesian geographical and socio-economic diversity (multi center studies). PMT biscuits~     supplementation intervention is accompanied by educational modules on Infant and Young Child~     Feeding (IYCF) in order to improve caregiver's knowledge and skills in providing economically~     affordable and nutritious food for their children. PMT biscuits supplementation evaluation~     will be assessed at 9 months observations (3 months intervals). The observation will be~     conducted every month up until the first 3 months then the observation will be continued in~     6th and 9th months of observation.~   "
4413|NCT03509142|"~     The study is a pilot clinical trial for Sirolimus-eluting Iron Bioresorbable Coronary~     Scaffold System（IBS）. The main purpose of this study is to evaluate the feasibility,~     preliminary safety and efficacy of IBS. To provide the basis for subsequent large-scale,~     multi-center, randomized controlled clinical trials of IBS.~   "
4414|NCT03509129|"~     The purpose of this study is to evaluate the effect of adding a team competition comprised of~     members of existing social networks to a technology-delivered program for enhancing physical~     activity among insufficiently active adults.~   "
4415|NCT03509116|"~     This study aims to understand the experience of the dietetic consultation from the~     perspective of nutritionally vulnerable older patients receiving oral nutrition support and~     dietitians, as well as other key stakeholders involved in the process of such a consultation.~      Malnutrition is prevalent and increases the risk of health complications and socioeconomic~     burden. Patients with malnutrition are often older patients with complex needs and therefore~     may require specialist knowledge and skills to provide nutritional support. Dietitians are~     uniquely skilled to assess the multiple factors that underpin diet and to tailor nutritional~     support, which could help improve outcomes. Although the causes of malnutrition are~     complicated, its treatment typically involves oral nutritional supplements, dietary advice or~     food-based interventions, either separately or in combination.~      Effectiveness of the various oral nutritional support interventions has been studied, with~     the findings on food-based interventions suggesting more research is needed and the~     widespread research on ONS suggesting contradictory results and interpretations. Despite~     this, the factors responsible for these inconsistencies have not been identified. There are~     no studies so far that have examined the patient experience of the consultation with the~     dietitian in the context of nutritional support. Although the patient experience of~     consultations is increasingly being recognised as an important part of investigating their~     effectiveness in healthcare, to date, there are a number of limitations in this literature,~     leaving the role of the patient experience in dietetic consultations for the management of~     malnutrition, poorly understood. It's probable that this is one contributing factor to the~     variation observed in the literature.~      A review of the literature indicates a need for exploration of the patient experience and its~     possible impact on the success or failure of the dietetic encounter. This study aims to~     address some of the knowledge gaps. The use of qualitative interviews will allow an in-depth~     understanding of the experience of the dietetic consultation for the provision of nutrition~     support and will utilise an overall illuminative evaluation approach to broaden that~     understanding by considering data from various sources. Participants will include older~     patients who are considered nutritionally vulnerable, their consulting dietitians and~     patient-nominated key stakeholders. Four clinical settings within the Trust where dietitians~     would often see patients for nutritional support will be included.~   "
4416|NCT03509103|"~     Background (brief):~        1. Burden: Abnormal prolonged labour and its effects are important contributors to maternal~          and perinatal mortality and morbidity worldwide. Although the partograph has been shown~          to be an efficacious tool for monitoring labor and identifying women in need of an~          comprehensive emergency obstetric intervention, it's appropriate use is questionable~          throughout the world. Evidence suggests that very few service provider use partograph~          despite recognizing its usefulness.~        2. Knowledge gap: In Bangladesh partograph is hardly used by the concern person though its~          importance and positive outcome is acknowledged at the national level. To introduce a~          digital partograph Johns Hopkins Program for International Education in Gynecology and~          Obstetrics (Jhpiego) developed an ePartogram device and WHO created partograph~          e-Learning tool. Jhpiego is currently testing three ePartogram implementations. However,~          till today, no data has been collected or analysed for any of these ePartogram models.~          The WHO e-Learning tool has been distributed to facilities like Kenyatta National~          Hospital via CD-ROM. In Kenya, a study also being conducted using a digital partograph~          (partopen) and results are yet to come.~        3. Relevance: The use of the paper partograph is found to be complex and too much~          time-consuming for effective use in low-resource settings where there has been~          inadequate health care staffing. These challenges highlight a need for strengthening~          providers' skills and/or developing new technologies that are suitable for low-resource~          countries and promote consistent, correct use of the partograph as well as, a labour~          monitoring system for the peripheral level health facilities. The benefits of this~          device are: ease of use, minimal training requirements, improved data quality and~          capture, and seamless integration into current local practice.~      Objectives: The current study aims-~        1. To explore the feasibility, acceptability of digital partograph use among health service~          providers in selected district hospitals in Bangladesh;~        2. To compare the user rate between paper and digital partograph during labour monitoring~          process in district hospitals in Bangladesh;~        3. To compare the outcome of paper and digital partograph use in respect to the birth~          asphyxia and prolonged labour rate after introducing digital partograph in selected~          district hospitals in Bangladesh;~        4. To determine the barriers and facilitating factors of introducing electronic partograph~          in district hospital in Bangladesh.~      Methods: A mixed-method prospective follow-up study with crossover design will be conducted~     in two DHs. One DH will serve as intervention (electronic partograph) hospital and another as~     control hospital (paper-based partograph). After applying the crossover design this~     allocation will be reversed. The total study will be completed within 18 months period.~     Nurse-midwives posted in obstetric wards will be the study participants. The sample size in~     each DH will be 506 mothers who will deliver their baby during the study period.~      Outcome measures/variables:~        -  Feasibility and acceptability of digital partograph use will be assessed among health~          service providers in selected DH in Bangladesh;~        -  The user rate of digital partograph will be estimated during labour monitoring process~          in DHs in Bangladesh;~        -  The birth asphyxia and prolonged labour rate will be estimated after introducing digital~          partograph in selected DHs in Bangladesh;~        -  The barriers and facilitating factors of introducing electronic partograph will be~          determined in DHs in Bangladesh.~   "
4417|NCT03509090|"~     Erector spinae plane block (ESPB) is a recently described block. Although there is still no~     consensus of its mechanism, the published case series seems to promise a new regional~     anesthesia technique for both chronic and acute pain. In this clinical trial, the~     postoperative analgesic effect of ESPB will be studied in patients underwent unilateral~     breast cancer surgery.~   "
4418|NCT03509077|"~     Patients over 65 years old who are exposed to alcohol or benzodiazepines will be recruited~     through the Fragility Assessment and Addictions Prevention Day Hospital, the Addiction~     Service and the Geriatric Post-Emergency Department. Toulouse University Hospital.~      The investigators will study descriptively the frequency of substance use disorder and the~     frequency of DSM-5 criteria associated with this diagnosis in a population of elderly~     subjects.~   "
6209|NCT03485586|"~     Comparison of the visual quality of traditional ultrasound biometrics and lenstar on the~     cataract patients with diabetic retinopathy after vitrectomy in the 3 months later.To~     evaluate the clinical value of lenstar in post-vitrectomy patients.~   "
4419|NCT03509064|"~     BACKGROUND Sjögren's syndrome is an autoimmune disease whose prevalence is estimated between~     200 and 500 patients per 100,000 persons in France (120 to 500,000 patients). It affects~     women (90%) between 40 and 60 years of age and main manifestations are generalized sicca~     syndrome (ocular, oral, cutaneous) and arthralgia. In 20% of cases, Sjögren's syndrome is~     associated with peripheral neuropathies, and the most common form is painful small fiber~     neuropathy (SFN). SFNs are mainly featured by neuropathic pain including burns (90%),~     numbness (87.5%), tingling (72.5%), electric shocks (70%) and tingling (82.5%) and also~     autonomic disorders (50 to 70%).~      However, there are still important issues that deserve to be investigated by clinical and~     basic research. Among these issues, this study will focus on:~        -  The impact of SFN on the quality of life of patients with Sjögren's syndrome.~        -  The medico-economic impact of the SFN taking into account the repercussions on the~          quality of life, including professional life, usual care cost (analgesics, medical and~          paramedical consultations, hospitalizations or emergency).~      EXPECTED RESULTS~        -  Confirmation of the major impairment in the quality of life of patients with~          Sjogren-associated SFN~        -  Analysis of correlations to highlight or not clinical or biological factors associated~          with quality of life impairment.~        -  Evaluation of the cost attributed to the presence of an SFN in patients with Sjögren's~          syndrome and the pharmaco-economic interest of conventional therapeutic management~          (analgesic treatment, consultation pain) compared to the cost of more aggressive~          immunomodulatory treatments.~   "
4420|NCT03509051|"~     Allogeneic hematopoietic stem cell transplant (HSCT) recipients are at risk of various~     bacterial infections, especially due to a progressive decrease of specific antibodies. Around~     90% of HSCT recipients have unprotective titers of specific antibodies to serogroups A and C~     meningogocci .(Parkkali 2001; Mahler 2012).~      Some small studies suggest that the response to meningococcal A and C vaccines is cose to~     100% after 3 doses given 18 months after transplant. Although the response to 2 doses of~     4CMenB is over 75% in other immunocompromised patients (Feavers, 2017), studies with 4CMenB~     are lacking after HSCT. Nevertheless, as serogroup B caused 74% of IMD in Europe between~     2004-2014 (Whittaker, 2017), the meningococcal B vaccination is recommended by the more~     recent guidelines from 6 months after transplant. There are, however, no data on the safety~     and efficacy of this vaccine after hematopoietic stem cell allograft (HSCT).~      The objective of this study is to assess the response to 2 doses of a multicomponent~     meningococcal B vaccine (4CMenB) given at 2 months interval in adult allogeneic HSCT~     recipients transplanted at least 6 months ago. The response will be assessed 1 month and 10~     months after the second dose of vaccine by measuring bactericidal antibodies against NadA,~     fHbp, NHBA and PorAP1 vaccinal antigens according to methods previously reported (Caron~     Lancet Infect Dis 2011). The response rate will be correlated to pre- and post-transplant~     factors. It is hypothesized that 80% of the patients should have protective titers one month~     after the 2nd dose.~   "
4421|NCT03509038|"~     In the population of obese women, the prevalence of urinary incontinence (UI) is around 70%.~     It was shown in the literature that weight loss by bariatric surgery allowed a significant~     improvement in the symptoms and impact on the quality of life of the IU. However, no~     prognostic factor for recovery has yet been identified and the pathophysiological mechanisms~     underpinning this improvement are not fully elucidated.~      The main objective of this study is to highlight the urodynamic changes associated with the~     improvement of the symptom and quality of life scores in a population of incontinent obese~     women before and after bariatric surgery.~   "
4422|NCT03509025|"~     This study is a long term follow-up study to investigate the safety of autologous~     transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with Knee~     Osteoarthritis.~   "
4423|NCT03509012|"~     This is an open-label, multicenter, phase I study to evaluate the safety and tolerability of~     durvalumab ± tremelimumab in combination with chemoradiation in patients with advanced solid~     tumors.~   "
4424|NCT03508999|"~     A rapid deterioration in oral hygiene occur after bonding of orthodontic appliances.~     Zachrisson and Zachrisson have reported that even after maintaining excellent oral hygiene,~     patients usually experience mild to moderate gingivitis within 1-2 months after orthodontic~     appliance placement. Slutzkey and Levin have reported a prevalence of 72 % gingivitis in~     orthodontic patients.~      The difficulty in maintenance of oral hygiene and inefficient removal of supragingival plaque~     due to the appliances lead to development of gingivitis and hyperplasia. Tooth brush access~     to the buccal surface of the teeth becomes problematic and predisposes plaque buildup around~     the brackets.~      Investigators are now focusing on the development of localized drug delivery systems that can~     allow maximum concentration on the target site, thus minimizing the potential systemic~     effects. Metronidazole has been used by several researchers due to its selective~     antimicrobial activity against the obligate anaerobes. The topical administration in gel form~     has several advantages. Miani et al concluded that the use of metronidazole gel significantly~     reduces the total bacterial count in the gingival crevicular fluid.~      In medicine and dentistry, active mobile telephone short-message service (SMS) reminders have~     been used to improve patient compliance and positive behavior changes. A study conducted by~     Epprighta et al have reported the effectiveness of SMS reminder in orthodontic patients. They~     have reported significantly lower bleeding, gingival and plaque indices scores in SMS~     reminder group as compared to control.~      Rationale:~      The application of metronidazole gel is effective in management of gingivitis in patients~     undergoing orthodontic therapy. Additionally, the constant reminder therapy at weekly~     interval would also lead to improvement in the oral hygiene. According to pertinent~     literature survey, none of the study has been conducted to compare the effectiveness of SMS~     reminders and use of anaerobic gel to reduce gingival inflammation.~      Null Hypothesis:~      Application of 0.8% metronidazole gel and mobile telephone short-message service oral hygiene~     reminders is equally effective in reducing the gingival inflammation in orthodontic patients~     with gingivitis as compared to control group.~      Objective:~      The objectives of the study will be to assess the use of topical gel or mobile telephone~     short-message service oral hygiene reminders can reduce gingivitis in orthodontic patients as~     compared to control group.~   "
4425|NCT03508986|"~     The purpose of the Chinese Familial Parkinson's disease Registry (CFPDR) is to develop a~     database of patients with familial Parkinson's disease (PD) in China.~   "
4426|NCT03508973|"~     The purpose of this study is to evaluate the safety and efficacy of Sculptra as a volume~     agent to improve décolletage crepiness and wrinkling.~   "
4427|NCT03508960|"~     The purpose of the Chinese Early-onst Parkinson's disease Registry (CEOPDR) is to develop a~     database of persons with early-onset Parkinson's disease (EOPD) in China.~   "
4428|NCT03508947|"~     This is a Phase 1, double-blind, placebo-controlled, single ascending dose cohort study to~     evaluate the safety, tolerability, and plasma concentrations of WVE-210201 in ambulatory and~     non-ambulatory male pediatric patients with DMD amenable to exon 51 skipping intervention.~   "
4453|NCT03508609|"~     This clinical trial will explore the safety and effect of GCSF-mobilized autologous ex vivo~     selected CD34 cells for the treatment of CMD in adults currently experiencing angina and with~     no obstructive coronary artery disease. Eligible subjects will receive a single intracoronary~     infusion of CLBS14.~   "
4429|NCT03508934|"~     More than 25% of the patients admitted in the general wards have a history of Diabetes~     Mellitus (DM). Up to 30% of the hospitalized diabetics develop hypoglycemia (low glucose~     values); a condition that is associated with seizures, cardiac arrhythmias, and even death.~     In Veterans, the prevalence is disproportionally higher. It is estimated that 40-50% of~     hospitalized Veterans are diabetics. In this clinical trial the investigators describe the~     development of a novel system, the Glucose Telemetry System (GTS), with which glucose values~     can be wirelessly transmitted from the patient's bedside to a monitor device at the nursing~     station. The goal of this work is to develop a more effective glucose surveillance system at~     the general wards, which can decrease hypoglycemia in the hospital and improve clinical~     outcomes.~   "
4430|NCT03508921|"~     Injection of OnabotulinumtoxinA (BTX-A) into the bladder is a widely used treatment option~     for patients with overactive bladder who have failed medical therapy. Urinary tract infection~     is the most common side effect of this procedure and therefore antibiotics are given around~     the time of injection in order to prevent these events. While antibiotics are commonly given~     at the time of injection, the duration of these antibiotic regimens are variable. The~     investigators propose a study to investigate different antibiotic protocols and their affect~     on the rate of urinary tract infection after injection.~   "
4431|NCT03508908|"~     This study will assess the impact of an HIV-1 RNA testing intervention targeting adult~     patients aged 18-39 years who seek urgent care for symptoms at primary care facilities and~     meet specific risk criteria for acute HIV infection. All newly diagnosed HIV-infected~     patients in the intervention arm will be linked to care and offered both immediate treatment~     and assisted partner notification. Partners will also be tested using the HIV testing~     intervention, and pre-exposure prophylaxis will be offered to uninfected individuals with~     HIV-infected partners. The cost-effectiveness of this intervention will be evaluated.~   "
4432|NCT03508895|"~     This clinical trial is being conducted to study the effect of whole hemp seed protein, hemp~     seed protein hydrolysate derived bioactive peptide and casein protein consumption on systolic~     and diastolic ambulatory blood pressure. This study is will be conducted in 35 hypertensive~     participants aged between ≥18 and ≤75 yrs who have systolic blood pressure higher than 130~     mmHg or diastolic blood pressure below 100 mmHg. The study will consist of 3 periods of 42~     days each during which participants will consume assigned treatment. Consumption of~     treatments will be from days 1 to 42. There will also be a washout period of a minimum of 14~     days between the 3 treatment periods where the participants can consume their habitual diets.~     The entire study is designed to take 22 weeks from start to completion. The participants will~     consume the assigned treatment twice a day. The treatments are in the form of a smoothie and~     the smoothies will consist of frozen fruit, fruit juice, vanilla and 25 g of protein from~     treatment protein powder which is 25 grams of casein protein, 25 grams of hemp seed protein,~     or 22.5 grams of hemp seed protein and 2.5 grams of hemp seed protein hydrolysate derived~     bioactive peptides. On days 1 and 42 of each treatment period of the trial, body weight,~     waist circumference, blood pressure, pulse wave velocity (PWV) and augmentation index (AI)~     will be measured. Ambulatory blood pressure (ABP) over 24 hours will also be measured on day~     1 of phase 1 and day 42 of each treatment period of the trial.~   "
4433|NCT03508882|"~     A triple-masked placebo-controlled trial assessing the efficacy and safety of pretarsal~     versus preseptal botulinum toxin for patients with eyelid spasm. The investigators~     hypothesize injection of botulinum toxin into the pretarsal orbicularis oculi muscle will~     have greater clinical efficacy, better measured quality of life, fewer complications, and~     better cost effectiveness in comparison to a preseptal pattern of injection.~   "
4434|NCT03508869|"~     To evaluate the safety and efficacy of Mirvaso® Gel and Dysport® for erythema and flushing of~     Rosacea.~   "
4435|NCT03508856|"~     Clinical Evaluation:~      Subjects having actinic keratoses and meeting Glogau Photoaging Class III or IV complete the~     FDA approved 3 day course of Picato® 0.015% gel as approved for the treatment of facial~     Actinic Keratosis. Each subject undergoes clinical multiple-angle standardized photographs on~     day 1, day 7, day 30, and day 60. Full face photography will be obtained with the medical~     research digital camera. Both subjects and investigators complete questionnaires at each~     visit with individual questions regarding improvement in actinic keratoses and overall skin~     appearance, wrinkling, dyschromia, erythema, and textural quality of skin. Each~     characteristic listed above will be graded on a 5 point scale ranging from 0 (lowest~     quality/worst appearance) to 5 (highest quality/best appearance). In addition, investigators~     will examine the subject's face and assign a numeric assessment on a 9 point scale ranging~     from 0 to 8 using previously published verified Griffiths' Photonumeric Photoaging scale. A~     second and third investigator will be presented at random blinded pretreatment (day 0) and~     posttreatment (day 60) photographs of each subject and be asked to assign a numerical value~     from Griffiths' Photonumeric Photoaging Scale. These blinded investgators will be given no~     information regarding which day each photograph represents. Comparison will be made of skin~     quality questionnaire scores from each visit and the pre and post treatment Griffiths'~     Photonumeric Grades.~      The investigator opted against a split-face study design given the difficulty of blinding~     with this type of study as well as difficulty recruiting subjects willing to treat for two~     separate courses.~      Histologic Evaluation:~      Standard 3mm dermatology punch biopsies from clinically sun damaged skin will be taken.~     Biopsy will be taken from either the cosmetically acceptable pre-or infra-auricular area. A~     digital photograph will be taken and used to identify the pre-treatment biopsy site. Biopsies~     will be taken of 5 subjects before treatment and at day 60. Day 60 biopsies will be taken~     immediately adjacent to previously photographed and identified pre-treatment biopsies.~     Biopsies will be stained with hematoxylin and eosin and histologic features of pre and post~     treatment skin will be evaluated. Measurement of actinic keratoses, solar elastosis and~     overall epidermal and dermal thickness pre and post treatment will be compared.~   "
4436|NCT03508843|"~     The investigators will conduct a pre-post trial with 150 parents in rural South Central~     Montana. The study will recruit families to cooperating community locations (e.g., churches,~     public libraries) to participate in research evaluating the efficacy of parents installing~     restraints with guidance from a remotely-located technician using interactive virtual~     presence. Following informed consent procedures, parents will complete a brief survey on~     behaviors, attitudes, and perceptions about child safety and restraints while an on-site~     technician evaluates baseline safety of the restraint. Parents will then engage remotely~     using their personal smartphone with an off-site certified car seat technician, obtaining~     advice to install the child restraint properly via the HelpLightning interactive virtual~     presence app. Following the remote interaction, the on-site technician will again inspect the~     restraint using the validated checklist (and correct any errors prior to the participant~     leaving). The overall goal is to demonstrate installation of child restraints can be~     effectively accomplished to rural populations using interactive virtual presence. The study~     has 2 specific aims:~      Specific Aim 1. Demonstrate technological and behavioral efficacy of providing instructions~     on child restraint installation remotely to rural populations. Demonstrate >95% of~     interactions proceed without technical problems, without reports of communication difficulty~     on either end of the exchange (the parent or the technician), and without interruption.~      Specific Aim 2. Identify accuracy of child restraint installation by parents using~     instructions provided by a remotely-located certified technician via interactive virtual~     presence. Demonstrate installation in this manner achieves ≥90% accuracy across all aspects~     of child restraint installation. Demonstrate installation in this manner significantly~     reduces restraint installation errors.~   "
4437|NCT03508830|"~     The Minimally Invasive Thoracic Surgery Intercostal Nerve Block Trial is a single center,~     double-blind, randomized, active-comparator controlled clinical trial to assess the analgesic~     efficacy of intercostal nerve block by Liposomal Bupivacaine versus Standard Bupivacaine in~     subjects undergoing lung resection by robotic or video-assisted thoracoscopic surgery.~   "
4438|NCT03508817|"~     Control of myopia progression has become an important goal because of concerns regarding~     significantly increased risks of retinal degeneration, retinal detachment, glaucoma and~     cataract associated with high myopia. It is also clear there prevalence of myopia in children~     and young adults is increasing all over the world. Several methods including use of~     progressive addition lenses, rigid gas-permeable contact lenses, and life-style modifications~     (increased outdoor activity) have reported to alter myopia progression with varying efficacy.~     In general they have yielded clinical results of marginal significance. Atropine sulphate eye~     drops has consistently been demonstrated to inhibit axial myopia progression in both humans~     and animal models. Yet it has not found widespread clinical application for myopia control~     due to ocular side-effects of cycloplegia and pupil dilation. Recently 0.01% atropine has~     been shown to be effective in arresting myopia progression without side-effects of~     cycloplegia and near vision impairment and pupil dilatation and increased light sensitivity.~     Almost all studies on atropine have been carried out on children of Chinese origin. Efficacy~     (concentration and dosing) and safety need to be established in the population of interest,~     before routine use can be recommended. We plan to evaluate the efficacy and safety of topical~     0.01% atropine eye drops in slowing the progression of myopia and ocular axial elongation in~     Omani children. A total of 150 children of ages 6-16 years will be randomized to two groups.~     Intervention group will receive atropine 0.01% once daily in each eye for two years (Phase~     1). Control group will not receive any medications. Follow up visits will be scheduled every~     three months in Phase 1. Subsequently, medication will be stopped and the study patients will~     be followed up every six months for one year (Phase 2). The progression of myopia (change in~     refractive error and axial length) will be compared in the two groups by objective methods.~   "
4439|NCT03508804|"~     The investigators theorize that the application of a lidocaine-prilocaine cream 5-10 minutes~     prior to the administration of a paracervical block could decrease pain associated with its~     administration and pain with abortion overall.~   "
4440|NCT03508791|"~     Investigators evaluate the effect of patient position (Trendelenburg and reverse~     Trendelenburg) on arterial, end-tidal and transcutaneous carbon dioxide partial pressure in~     patients undergoing laparoscopic surgery.~   "
4441|NCT03508765|"~     The purpose of this study is to learn about possible changes in thinking (cognitive)~     abilities, such as memory skills, and in brain anatomy and function, in adults with multiple~     myeloma who are treated with high-dose chemotherapy followed by ASCT.~   "
4442|NCT03508752|"~     The phase I component of the study is to identify maximal tolerated dose (MTD). The phase II~     is to evaluate neurocognitive decline.~   "
4443|NCT03508739|"~     Type 2 diabetes is common, increases in prevalence with age, and patients with diabetes have~     an increased risk of cardiovascular disease. A relatively new cardiovascular medication~     currently used for the treatment of heart failure in the United States inhibits an enzyme~     that breaks down a variety of signaling hormones. This clinical trial tests if it may also be~     a target for the treatment of diabetes by decreasing the breakdown of a hormone that~     increases insulin release after a meal.~   "
4444|NCT03508726|"~     This is a single-arm open-label phase Ib/II clinical study assessing the efficacy of~     concurrent high dose ascorbate in combination with radiotherapy in patients with locally~     advanced, resectable, high grade sarcomas.~   "
4445|NCT03508713|"~     To focus on the real world treat-to-target rate of early rheumatoid arthritis patients who~     will be treated according to the 2015 American College of Rheumatology Guideline for the~     Treatment of RA.~      To explore the factors which influence the treat-to-target outcome.~   "
4446|NCT03508700|"~     Evaluate the long-term safety of TNX-102 SL 5.6 mg taken daily at bedtime over an additional~     40 weeks in patients with PTSD who have participated in a double-blind lead-in study and~     completed an initial 12-week open-label extension study (TNX-CY-P303).~   "
4447|NCT03508687|"~     The overall objective of this study is to assess the efficacy and safety of two dosing~     regimens of gemcabene (300 mg once daily for 24 weeks or 300 mg daily for 12 weeks followed~     by 600 mg daily for 12 weeks) in up to eight patients with Familial Partial Lipodystrophy~     with high triglycerides and Non-Alcoholic Fatty Liver Disease. The study will consist of a~     six week Wash Out Period, up to a 28 day Screening Period, a 24 week Treatment Period, and a~     follow-on safety assessment four weeks post final dose. Study participation will last~     approximately 4 months and includes at least 9 study visits, and can be as many as 11 study~     visits.~   "
4448|NCT03508674|"~     The purpose of this study is to evaluate the safety and effectiveness of the Levita Magnetic~     Surgical System in patients undergoing bariatric procedures~   "
4449|NCT03508661|"~     Many people living with a rare disease turn to peer-led support groups to cope with their~     condition and access educational resources. Systemic sclerosis (SSc), or scleroderma, is a~     rare autoimmune connective tissue disease where peer-led support groups play an important~     role. There are currently approximately 200 SSc support groups in Canada and the US, most of~     which are led by people with SSc. Many SSc patients, however, cannot access support groups.~     In other cases, support groups are not sustained due to factors that include the burden on~     group leaders living with a serious, unpredictable disease and limited group leadership~     skills of some untrained leaders. Our partners from Scleroderma Canada and the Scleroderma~     Foundation in the US are committed to improving support group accessibility and~     effectiveness. These organizations maintain a list of active support groups, but currently do~     not provide training or other resources to groups or their leaders. To address this gap, our~     team, including investigators and patients from the Scleroderma Patient-centered Intervention~     Network (SPIN), developed the Scleroderma Support group Leader EDucation (SPIN-SSLED)~     Program, which is designed to improve support group leader confidence and self-efficacy,~     reduce burnout, improve emotional well-being, and improve health-related quality of life.~      In the planned full-scale randomized controlled trial (RCT) that will follow our feasibility~     trial, we will evaluate whether the SPIN-SSLED Program is effective in improving SSc support~     group leaders' self-efficacy for carrying out their leader role (primary) and if it reduces~     burnout, improves emotional well-being, and improves health-related quality of life~     (secondary). Thus, the SPIN-SSLED Feasibility Trial answers the following research questions:~     (1) Is a full-scale SPIN-SSLED RCT feasible? (2) Are adaptations needed to the research~     design for the planned full-scale RCT? (3) Are there ways to improve the SPIN-SSLED Program~     for delivery in the planned full-scale RCT based on input of support group leaders who~     participate in the feasibility trial?~   "
4450|NCT03508648|"~     The study will enroll only from the first 225 subjects who were randomly assigned to~     treatment in G201002 (irrespective of the treatment allocation, i.e., GTx-024 or placebo) and~     who have completed the 12-week treatment period and 16-week durability period to assess the~     long-term durability of response to GTx-024 on SUI symptoms. The extension study will follow~     subjects for an additional 20 weeks to help better assess the durability of response in these~     subjects and will provide additional efficacy and safety data for the subjects. Subjects will~     not be provided with any study treatments and will be off-drug during this extension study.~   "
4451|NCT03508635|"~     The purpose of this study is to evaluate the dose-related safety, tolerability,~     pharmacokinetics (PK) and pharmacological effects (PD) of CORT125134 and its active~     metabolite CORT125201 after single and multiple ascending oral doses of CORT125134 in healthy~     subjects.~   "
4452|NCT03508622|"~     This pilot study aims to evaluate the feasibility and efficacy of a group telehealth model,~     compared with a standard multi-disciplinary, individualized, in-clinic weight management~     model, for treatment of adolescents with obesity.~   "
15996|NCT03357562|"~     The aim of the study is to assess the diagnostic sensitivity of MRI to detect changes in~     Helbich-Bhalla scoring over time in patients with cystic fibrosis~   "
4454|NCT03508596|"~     The aim of this study is to identify risks for work-related stress, stress reactions and~     long-term consequences among nurses, physicians, medical-technical and medical-therapeutic~     professions in Switzerland and to reduce those factors by an educational intervention for the~     supervisors.~   "
4455|NCT03508583|"~     Family-centred care (FCS) is considered the best practice in providing rehabilitation to~     children with disabilities and special needs. Family-centred care has been described as a~     partnership approach to healthcare decision making. As a philosophy of healthcare, today many~     multidisciplinary healthcare facilities have organized their services according to a~     family-centred approach. TheMeasure of Processes of Care (MPOC) is the most widely used~     instrument to assess parents' self-reported experiences of family-centred behaviours of~     rehabilitation services providers. The aim of this study is to translate the scale to Turkish~     and to determine validity and reliability of The Measure of Processes of Care (MPOC 56- 20-~     SP)~   "
4456|NCT03508570|"~     The goal of this clinical research study is to find the safest combination dose of nivolumab~     and ipilimumab that can be given by an intraperitoneal (IP) infusion to patients with~     gynecologic cancers. An IP infusion is an injection of the study drugs into the abdomen.~      This is an investigational study. Nivolumab and ipilimumab are both FDA approved and~     commercially available for the treatment of many different types of cancer. However, they are~     not FDA-approved for the treatment of gynecological cancers. It is considered investigational~     to use the combination of ipilimumab and nivolumab in patients with gynecological cancers and~     to give these drugs by an IP infusion.~      The study doctor can explain how the study drugs are designed to work.~      Up to 48 participants will be enrolled in this study. All will take part at MD Anderson.~   "
4457|NCT03508557|"~     This study evaluates the use of advance care planning conversation tools with patients~     attending their family doctor's office. Patients complete tools about their values and~     wishes, and a health care provider uses a structured discussion tool to talk about the~     patient's health condition and future wishes. The patient's family member/substitute~     decision-maker is encouraged to attend and be part of the discussions.~   "
4458|NCT03508544|"~     Multimodal analgesia is used to control postoperative pain in hip surgery. Quadratus lumborum~     block is an effective regional anesthesia technique for hip and proximal femur surgery. The~     erector spinae plane block applied to the lumbar region was also reported to provide~     effective analgesia in these surgeons. In this study, we aimed to determine and compare the~     effects of quadratus lumborum block and lumbar erector spinae plane block on postoperative~     pain in hip and proximal femur surgeons.~   "
4459|NCT03508531|"~     Erector Spinae Plane Block is a newly defined regional anesthesia technique. Its use for many~     indications has been identified by case reports in the literature. As the investigators have~     considered that erector spinae plane block could be efficacious for providing postoperative~     analgesia in laparoscopic cholecystectomy, the investigators have implemented the application~     of this blockade into practice at the clinic.Oblique subcostal transverse abdominis plane~     block (OSTAP) is another regional anesthesia technic used for postoperative analgesia in~     laparoscopic cholecystectomy. Main purpose of this study is to compare the analgesic effect~     of ultrasound-guided erector spinae block and OSTAP in laparoscopic cholecystectomy.~   "
4460|NCT03508518|"~     Getting a consultation with a psychiatrist within an appropriate time is one of the main~     issues reported by general practitioners (GP) for patients suffering from mental disorders in~     primary care. Consultation liaison in psychiatry is a system focused on general~     medicine-psychiatry collaboration. The aim of the present study is to evaluate the impact of~     the consultation-liaison on the adequacy of the access time to a psychiatric consultation~     according to the degree of urgency evaluated by the GP.~   "
4461|NCT03508505|"~     Cardiac surgery can be not infrequently complicated by cardiac low-output syndrome due to~     critical preoperative conditions such as cardiogenic shock, poor left ventricular function~     and severe myocardial ischemia. Suboptimal myocardial protection, technical errors at graft~     anastomoses or of prosthesis implantation, and hibernating myocardium may further contribute~     to cardiac low-output syndrome occurring immediately or shortly after cardiac surgery. In~     this setting, veno-arterial extracorporeal oxygenation (VA-ECMO) is the only means to provide~     cardiopulmonary support to recovery or as bridge to transplantation.~      Data on the real benefit of VA-ECMO after cardiac surgery is limited and often derived from~     heterogeneous patient populations, which prevent conclusive results on the benefits of~     VA-ECMO in this setting. This issue will be investigated in the present retrospective~     European multicenter study.~      In this setting, veno-arterial extracorporeal oxygenation (VA-ECMO) is the only means to~     provide cardiopulmonary support to recovery or as bridge to transplantation.~      Data on the real benefit of VA-ECMO after cardiac surgery is limited and often derived from~     heterogeneous populations of patients who underwent different cardiac procedures. Patients~     with cardiac low-output after surgery for aortic dissection or valve surgery are expected to~     have different baseline characteristics (such as age and comorbidities) and underlying~     cardiac disease than patients undergoing isolated coronary surgery. Furthermore, available~     studies included patients operated during the nineties and this does not provide an exact~     measure of the benefits of this treatment strategy.~      The possible benefits of using VA-ECMO after adult cardiac surgery will be investigated in~     this retrospective European multicenter study.~   "
4462|NCT03508492|"~     The development of surgical site infections (SSI) in clean-contaminated surgery is regarded~     as being preventable. Known to be effective in the prevention of surgical site infection are~     the adequate sterilization of the surgical instruments, asepsis during operation, antibiotic~     prophylaxis where indicated, and certainly the preparation of the skin at the incision site.~     During the last decades the use of alcoholic chlorhexidine has replaced povidone iodine for~     preoperative skin preparation. In order to improve the way alcoholic chlorhexidine is~     applied, pharmaceutical industry has developed new applicators.~      This randomized study was conducted to know the surgeons' satisfaction within the use of two~     tinted applicators: Chloraprep® and Nex Clorex 2%~   "
4463|NCT03508479|"~     This study is designed to characterize in detail the clinical, physiologic, and inflammatory~     features of Human Rhinovirus (HRV) infection in healthy volunteers without underlying lung~     disease while also evaluating the safety of HRV administrations.~   "
4495|NCT03508063|"~     A clinical trial to validate the MCPM (Multi-parameter Combined Physiological Signal-based~     Monitoring), in estimating autonomic nervous system activity level, at rest and while exposed~     to noxious stimuli.~   "
4464|NCT03508466|"~     Iron deficiency is common and when oral treatment is not sufficient intravenous application~     is indicated. Hypersensitivity to intravenous iron nanomedicines is rare but does occur and~     little is known about the underlying mechanism but complement activation has been suggested.~      This is a purely exploratory study as it is not yet known whether in vitro complement~     activation can be stimulated by titration with iron preparations. These data will provide~     first empirical evidence of whether and to what extent complement activation occurs in this~     population.~   "
4465|NCT03508453|"~     Fifty patients with amyotrophic lateral sclerosis that is progressing rapidly will be~     randomized to receive either the monoclonal antibody IC14 or placebo to be given~     intravenously over two hours twice weekly for 12 weeks. Blood and urine tests will be done to~     measure biomarkers in order to evaluate clinical response and to monitor for safety. Other~     evaluations include patient questionnaires about function, quality of life and mental~     function; pulmonary function test; and sniff nasal pressure.~   "
4466|NCT03508440|"~     Facial nerve paralysis is due to inflammation around the facial nerve. Current treatment for~     facial nerve paralysis is a 10 day course of oral steroids (which will reduce the~     inflammation), with electrodiagnostic testing. There have been limited studies on the use of~     intratympanic steroid injection, in addition to oral steroid, in the recovery of facial nerve~     paralysis. There are indications that the use of intratympanic injections, in addition to the~     oral steroids, will speed up the recovery rate of the facial nerve paralysis, as well as~     improve the complete recovery of the facial nerve paralysis. This study will randomize~     patients with facial nerve paralysis into two groups: 1) oral steroid only and 2) oral~     steroid plus a 3 intratympanic steroid injections spaced out over three weeks. There are a~     subset of patients that are unable to take oral steroids for medical reasons (such as~     diabetes); these patients will be placed into a third group and only receive 3 intratympanic~     steroid injections space out over three weeks. Subjects that are to receive the intratympanic~     injection will receive pre- and post-hearing exams as part of their standard of care.~     Patients will be evaluated via videorecording by two blinded investigators as well as in~     person evaluations by the unblinded treating physician.~      Subjects will be followed until complete facial nerve paralysis recovery or one year~     post-treatment, whichever comes first.~   "
4467|NCT03508427|"~     Bipolar disorder is a severe psychiatric illness with chronic course and it is associated~     with high risk of relapse and hospitalisation, and many patients do not recover to their~     previous psychosocial functioning. Major reasons for poor outcomes are delayed intervention~     for prodromal mood and behavioural symptoms as well as incomplete treatment responses.~     Current diagnostic approaches used to assess mood symptoms rely on symptom-based categories,~     which lack sensitivity to detect subtle mood and behavioural changes. Therefore, the ability~     to better characterizing bipolar patients may allow to detect possible differences in the~     illness activity.~      On the other hand, there is a growing interest in the potential use of mobile technologies~     such as mobile apps, smartphone and internet in psychiatric care. Some projects have been~     testing the potential benefits of mobile apps to assess and treat individuals at-risk or~     suffering from mood and bipolar disorders, using online signs and symptoms monitoring, yet to~     the investigators knowledge, none of them have integrated a dimensional approach in a~     smartphone app to assess mood and behavioural alterations and bipolar illness activity,~     including subjective and objective data (e.g. physical activity, social activity, etc.).~      In this feasibility study the investigators will evaluate the potential relevance of Toi Même~     app to self-monitoring mood and behavioural changes in bipolar patients with different mood~     phases compared to the gold-standard mood rating tools used in clinical practice. All~     patients will be followed for 3 months, with outcome assessments after 2 weeks, after 1~     month, 2 months and after 3 months.~   "
4468|NCT03508414|"~     The aim of this project is to characterize the influence of a ketogenic diet and intermittent~     therapeutical fasting on the course of the disease, as measured by T2-hyperintense cerebral~     lesions with magnetic resonance tomography (MRT) in patients with multiple sclerosis (RRMS).~     The investigators expect in both intervention groups fewer cerebral T2 lesions occurring~     after 18 months in comparison to the control group and as detectable by MRT. According to~     current recommendations of the German Society of Nutrition (DGE), the control group receives~     a vegetarian-focused, anti-inflammatory diet.~   "
4469|NCT03508401|"~     Acute circulatory failure is frequent, affecting up to one-third of patients admitted to~     intensive care units (ICU). Monitoring hemodynamics and cardiac function is therefore a major~     concern. Analysis of respiratory diameter variations of the superior vena cava (SVC) is~     easily obtained with transesophageal echocardiography (TEE) and is helpful to assess fluid~     responsiveness.~      Transthoracic echocardiography (TTE) exploration of the SVC is not used in routine. Recently,~     micro-convex ultrasound transducers have been marketed and these may be of use for~     non-invasive SVC flow examination. However, analysis of diameter variations of the SVC with~     TTE does not seem to be possible since the approach from the supraclavicular fossa does not~     allow for a good visualization of the SVC walls.~      It was recently demonstrated in a short pilot study that TTE examination of the SVC flow with~     a micro-convex ultrasound transducer (GE 8C-RS) seems both easy to learn and to use~     (feasibility = 84.9%), and is reproducible in most ventilated ICU patients with an intraclass~     correlation coefficient for the systolic fraction of the superior vena cava flow of 0.90 (95%~     confidence interval [0.86-0.93]).~      The hypothesis is that cardio-respiratory interactions in intubated-ventilated patients are~     responsible of SVC flow variations and that the analysis of the SVC flow respiratory~     variations could be a new predictive tool of fluid responsiveness.~   "
4470|NCT03508388|"~     Investigator seek to determine whether the volume of the liver can predict the survival after~     a decompensation of a patient suffering from chronic liver disease caused by excessive~     alcohol consumption (or alcoholic cirrhosis). Our hypothesis is that patients with a small~     liver have a lower survival compared to patients having a normal sized liver.~   "
4508|NCT03507894|"~     The aim of this study is to determine the impact of an m-health based intervention on long~     term adherence to a rehabilitation program for stroke survivors.~   "
4509|NCT03507881|"~     The present study is planned to demonstrate the efficacy and safety of a new pedicle screw~     system for the specific indication of isthmic spondylolisthesis, as this condition concerns~     relatively young patients requiring good fixation of the performed reposition to come to~     satisfactory clinical results.~   "
4471|NCT03508375|"~     Systemic Scleroderma (SCS) is an autoimmune disease characterized by vascular involvement, a~     dysimmune condition, cutaneous and visceral fibrosis. Interstitial lung disease (ILD) affects~     75% of SSc patients and is the leading cause of death in SSc. No diagnostic or prognostic~     biomarkers of SSc-associated ILD have been validated to date. The search for such a serum~     biomarker is essential to assess the severity of these patients and to help the therapeutic~     management.~      We have shown that soluble fractalkine is elevated in SSc patients, especially in SSc~     patients with ILD. The fractalkine is both an endothelial adhesion molecule and a chemokine~     that binds to the CX3CR1 receptor expressed by immune populations. It would thus reflect the~     vasculopathy and inflammation that lead to the fibrosing pulmonary involvement of this~     disease.~      Objectives and means: We aim to perform a low-risk interventional biomedical research which~     main objective is the quantitative evaluation of soluble fractalkine in SSc patients with ILD~     in comparison with SSc patients without ILD. This epidemiological, explanatory, analytical,~     single-center study will comprise three groups: 1 / SSc without ILD (control group in the~     context of SSc), 2/ SSc with ILD and 3/ patients with idiopathic pulmonary fibrosis (IPF)~     (control group of the ILD). Secondary objectives are evaluation of: 1 / fractalkine levels in~     the IPF, 2 / correlations between fractalkine levels and severity of ILD and of SSc disease~     over time, 3 / correlations between fractalkine and 2 other biomarkers: KL-6 (marker of~     pulmonary fibrosis) and soluble CD146 (sCD146, marker of vasculopathy), 4 / predictive values~     of the decline in lung function of these 3 markers.~   "
4472|NCT03508362|"~     The aim of the present project is to reveal, using Functional Magnetic Resonance Imaging~     (fMRI) in drug users, a specific modulation of brain structures and circuits involved in~     cognitive control (and especially those of inhibitory control) and reward while subjects are~     performing under the influence of drug-associated cues and in various social contexts.~      This hypothesis, based on the animal work, is that the subthalamic nucleus (STN) should play~     a critical role in these processes. Addictive behaviour can be seen as a loss of control~     resulting from reduced inhibitory control, leading to compulsive drug use. These disorders~     are known to be associated with a hypoactivation of specific frontal regions such as the~     anterior cingulate cortex or the prefrontal cortex.~      For the present experiment, it is chosen to use a procedure well established for~     neurophysiological and behavioural assessment of inhibitory processes : the  stop-signal~     reaction time task .~      This task requires to inhibit a motor response (press a button) at the onset of a stop signal~     (a tone) that occurs while the response is already engaged. In this task associated with~     fMRI, it was previously shown that the STN is involved in the control of inhibition. These~     results confirm our data in the rat, and especially those showing that STN lesions block the~     ability to stop. The stop signal task will thus be appropriate to study the effect of the~     social context on inhibitory processes in a population of cocaine users.~      In cocaine abusers, it was shown that inhibitory processes are affected. Here we aim at~     testing this population of subjects while they perform the stop task, but adding an implicit~     cognitive load induced by visual cues associated or not with cocaine intake. Since it want to~     assess the influence of a peer on both the performance and the associated cerebral~     activities, it will also control the presence of a peer observer in the procedure.~      There will thus be three experimental factors, one inter-subject factor (the experimental~     group, cocaine users or controls) and two intra-subject factors (cocaine associated or~     neutral cue; presence of a peer observer). The stop-signal task should induce increased~     activity of the STN that should be modulated by the cocaine-associated cues and by the~     presence of a peer.~   "
4473|NCT03508349|"~     The main aim of this study is to test the primary hypothesis that the addition of~     intermittent screening and treatment of malaria in pregnant women (ISTp) who receive routine~     antenatal care (ANC) in health facilities in high malaria transmission areas in Rwanda will~     reduce malaria prevalence among pregnant women when compared to routine antenatal cares~     services alone.~   "
4474|NCT03508336|"~     This study is aimed to detect the initiation of swallowing act in DOC patients, to find if it~     is a good item as a stimulus and to detect the relationship between the initiation of~     swallowing act and the prognosis of DOC patients.~   "
4475|NCT03508323|"~     To assess the efficacy and safety of Teneligliptin in Patients aged 65 and Older with~     inadequately controlled type 2 diabetes.~   "
4476|NCT03508310|"~     The purpose of this project is to beta-test a brief waiting room video intervention that~     promotes early initiation of antiretroviral treatment among treatment-naïve HIV-positive~     patients, adherence to antiretroviral treatment and retention in care among HIV-positive~     patients currently on therapy, sexual risk reduction tailored to HIV-positive persons, and~     patient-initiated discussion of these topics with their health providers. The video is~     currently being created, and will be ready for beta-testing by June 1, 2016. Results of the~     beta-testing will be used to refine and improve the video before dissemination to HIV/AIDS~     treatment facilities nationally. This video project is being funded by the Centers for~     Disease Control and Prevention, Division of HIV/AIDS Prevention (DHAP).~   "
4477|NCT03508297|"~     A reflectance confocal microscope is a machine which is able to examine the upper layers of~     the skin painlessly and without the need for taking a biopsy. We would like to examine the~     images taken by the confocal microscope to see if it can help more accurately identify~     lesions which are worrying rather than a benign mole. We are performing this study in~     patients in whom we have recommended excising a mole to exclude a cancer. If the results of~     the study show that the confocal microscope can help more accurately diagnose Melanomas then~     this would reduce the number of biopsies that are taken that turn out not to be cancerous (ie~     unnecessary biopsies).~   "
4478|NCT03508284|"~     Multiple sclerosis (MS) is a chronic inflammatory disease affecting the central nervous~     system. It is reported that 85% of patients with multiple sclerosis have gait disturbance,~     88% balance, and 35-90% fatigue (1, 2, 3). In addition, 65% of patients are reported that~     their cognitive functions have regressed (4).~      It is important to increase the independence of the MS patients in activities of daily living~     (ADL). Almost all of ADL requires many activities at the same time. For example,~     toothbrushing involves both the standing balance and the motor activity of the upper limb at~     the same time. It also requires cognitive tasks such as attention and focusing. Many~     activities that seem to be the only task are actually multitasking (5).~      The aim of this study is to investigate the effects of motor and cognitive additional task on~     balance, mobility and upper limb performances in MS patients and to determine the factors~     associated with dual-task performance.~   "
4479|NCT03508271|"~     Observational study of elderly individuals diagnosed with Non-Valvular Atrial Fibrillation~     and Heart Failure who are beginning oral blood thinners~   "
4480|NCT03508258|"~     Study of patients with nonvalvular atrial fibrillation (NVAF) who are newly prescribed NOACs~     (Novel Oral Anticoagulants) in routine clinical practice in England~   "
4481|NCT03508245|"~     This study examines circadian rhythms and morningness-eveningness preference in youth with~     Persistent Tic Disorders (PTDs), including Tourette's Disorder (TD); and assesses the effects~     of wearable short wavelength light therapy on circadian rhythms and tic symptoms.~   "
4482|NCT03508232|"~     Current medical treatment allows more people to survive heart attacks than in the past.~     However, some of the survivors suffer heart disease and require hospitalization later on. The~     causes behind this heart disease (heart failure) after a heart attack are poorly understood.~      Matrix metalloproteinase 2 (MMP-2) is a protein that cuts other proteins into pieces, and is~     activated in heart muscle when there is a heart attack. MMP-2 causes heart injury when the~     blood flow to the heart is restored after the attack. Blocking MMP-2 activity is a potential~     therapy to prevent heart injury under these circumstances. The only MMP-2 inhibiting drug~     currently approved for clinical use is doxycycline, specifically used to treat periodontitis~     (gum inflammation) and rosacea (a skin condition). At higher doses doxycycline also acts as~     an antibiotic for which it has been clinically used for decades.~      A previous clinical study found that taking doxycycline twice a day, for one week after a~     heart attack improved the health of the patients' hearts. We conducted a similar study in~     patients that had surgery to replace blocked coronary arteries (blood vessels that feed the~     heart muscle). These patients took a low dose of doxycycline once a day for 2 days before~     surgery, on the day of the surgery, and three days after surgery. The participants in this~     study showed no adverse effects of using doxycycline.~      Our goal is to see if doxycycline protects the hearts of patients that suffered a heart~     attack. All patients will receive standard clinical care for their condition, but in addition~     will take a doxycycline capsule twice a day, or a placebo capsule for 7 days, as soon as~     possible after being diagnosed with a heart attack. Three months later, we will evaluate the~     patients by looking at their heart structure using magnetic resonance imaging (MRI). MRI is a~     powerful tool that allows doctors to see inside the body without surgery or X-ray radiation.~     The hearts of those patients that received doxycycline are expected to be healthier than~     those who received placebo.~      We plan to promote the use of doxycycline to protect the hearts of patients with heart~     attacks. If successful, doxycycline could help improve the quality of life of heart attack~     survivors.~   "
4483|NCT03508219|"~     The primary objective of this study is to study the safety and efficacy of the BiOSS LIM C~     with respect to Patient oriented Composite Endpoint (PoCE) at 12 months in a real world~     left-main bifurcation population and as compared with a prespecified performance goal.~   "
4484|NCT03508206|"~     Available literature suggests that flavanols-rich foods, and more especially monomeric~     flavanols-rich foods such as grape, can have an acute effect on cognitive functions via~     different mechanisms such as cerebral blood flow improvement.~      The objective of this study is to investigate the effect of a Standardized botanical blend~     rich in polyphenols (SBRP), on cognitive functions, together with endothelial function in~     healthy students. Moreover, in order to provide supportive evidence on the mechanisms and~     biological plausibility to the clinical effects of the product, appropriate biological~     parameters and circulating metabolites will be assayed.~      The study design will be a double-blind, randomised, placebo controlled, crossover study. A~     total of 30 healthy volunteers will be included. Each participant will receive a single dose~     of SBRP and placebo capsules, during 2 separate experimental visits and in a counterbalanced~     order. There will be a 1 week washout period between the 2 experimental visits. During each~     experimental visit, after a training battery volunteers will be administered a cognitive test~     battery (COMPASS) before product intake (baseline, B0) and 6 times after product intake (B1~     to B6, from 90 min post-dose to 160 min post-dose).~   "
4485|NCT03508193|"~     This will be an open label, pilot study over 8 weeks in children with newly diagnosed Crohn's~     disease treated with a smoothie designed to emulate formulas used for exclusive enteral~     nutritional therapy. In place of formula, whole-foods based smoothie recipes and the food to~     create the smoothies will be given to each participant/family. The smoothies will be based~     upon the concept of reverse-engineering of exclusive enteral nutrition (RE-EEN). The smoothie~     recipes will involve whole foods that can be blenderized to liquid consistency. Similar to~     the formulas used for EEN, the smoothies will provide calories, protein, fat, and~     carbohydrates in a distribution to support growth and development.~   "
4486|NCT03508180|"~     Chemotherapy with platinum salts is very emetic. The aim of this study is to evaluate the~     benefits of foot reflexology in nausea and vomiting induced by platinum salts-based~     chemotherapy in patients with thoracic or digestive tumors.~   "
4487|NCT03508167|"~     National clinical trial, phase III, monocentric, randomized, double-blind, controlled,~     parallel, study of superiority, in which two hundred and thirty four (234) participants of~     both sexes, aged equal or more than 18 years and equal or less than 54 years, will be~     randomly allocated in one of two treatment groups. The first group will use Dorilax® plus~     thermal band and the second group will use thermal band plus placebo. The results will show~     the efficacy and security of Dorilax® and compare the efficiency of Dorilax® and thermal~     band.~   "
4488|NCT03508154|"~     This study is an open-label with a randomized, cross-over design using standard GI~     methodology.~   "
4489|NCT03508141|"~     1. Haemorrhage in severe trauma is a significant cause of mortality and is potentially the~          most preventable cause of death in paediatric trauma patients~        2. Trauma Induced Coagulopathy (TIC) is a complex coagulopathy associated with severe~          trauma~        3. Hypo/dysfibrinogenaemia plays an important role in TIC~        4. Early replacement of fibrinogen may improve outcomes~        5. Fibrinogen replacement is potentially inadequate in standard fixed ratio Major~          Haemorrhage Protocols (MHP) utilising Plasma and/or Cryoprecipitate~        6. The majority of centres utilise cryoprecipitate for additional fibrinogen~          supplementation as part of a MHP~        7. Cryoprecipitate administration is often delayed (between 60 - 120 minutes) in a fixed~          ratio MHP~        8. It is clear early intervention in severe traumatic haemorrhage is associated with~          improved outcomes - CRASH 2 and PROPPR studies~        9. Increasing interest in the use of Fibrinogen Concentrate (FC) in severe bleeding but not~          supported by high level evidence~       10. Benefits of FC - viral inactivation, known dose, easily reconstituted, can be~          administered quickly in high dose and stored at room temperature in the trauma~          resuscitation bay~      12. No previous studies comparing FC and Cryoprecipitate in bleeding paediatric trauma~     patients 13. Fibrinogen supplementation will be guided by an accepted ROTEM targeted~     treatment algorithm 14. Pilot, multi-centre randomised controlled trial comparing FC to~     Cryoprecipitate (current standard practise in fibrinogen supplementation) 15. Hypothesis:~     Fibrinogen replacement in severe traumatic haemorrhage can be achieved quicker with a more~     predictable dose response using Fibrinogen Concentrate compared to Cryoprecipitate 16. It is~     imperative that robust and clinically relevant trials are performed to investigate fibrinogen~     supplementation in paediatric trauma patients before widespread adoption makes performing~     such studies unfeasible~   "
4490|NCT03508128|"~     Subjects with Medtronic Micra leadless pacemaker who require surgical procedures will have~     postoperative interrogations reviewed for evidence of electromagnetic interference (EMI).~   "
4491|NCT03508115|"~     Study about the improvement of cognitive, psychopathological and functional abilities in~     Hepatitis C Virus (HCV) infected patients after eradication of the virus with direct~     antiviral agents.~   "
4492|NCT03508102|"~     Patients undergoing caesarean delivery under inhalation anaesthesia are at a high risk of~     awareness, especially in the period before delivery. The investgators assessed the effects of~     remifentanil on the bispectral index (BIS) in the interval before delivery.~   "
4493|NCT03508089|"~     It's a pilot, interventional prospective monocentric study. It aims to compare the wall /~     lumen ratio (WLR) of retinal arterioles (common marker of microangiopathies) between patients~     with multiple sclerosis and controls using the technique of adaptive optics.~   "
4494|NCT03508076|"~     Constipated patients in the participating center from February 2017 to June 2018~     (anticipated) were prospectively enrolled. Number of defecation per week，Bristol score，and~     Colon transmission experiment were compared with the constipated patients before treatment.~   "
4496|NCT03508050|"~     Nowadays, lung isolation techniques are an essential part of thoracic anesthesia. The two~     principal devices used in order to achieve one-lung ventilation (OLV) are the double lumen~     tube (DLT) and the bronchial blocker (BB). Even though DLT and BB have always been considered~     equally effective in lung isolation, a study recently published by Bussières et al.~     demonstrated the clear superiority of BB over DLT in terms of rapidity and quality of lung~     collapse. In order to explain this result, a physiologic study was recently conducted. During~     this project, some interesting discoveries were made. In fact, during lung isolation, while~     the chest is closed, there is a buildup of negative pressure in the NVL until pleural~     opening. Moreover, an absorption of ambient air through the lumen of the DLT or through the~     internal channel of the BB is observed. Putting all these elements together, a possible~     explanation for the superiority of BB over DLT was obtained. Indeed, in the first study of~     Bussières, the internal channel of BB was occluded. By doing so, there were no possible~     aspiration of ambient air in the NVL. This condition may have accelerated the absorption~     atelectasis of the NVL that occurs during lung collapse by reducing NVL volume and by~     conserving a higher alveolar partial pressure of oxygen in it.~      The hypothesis is that when using a DLT in OLV, occluding the non-ventilated lung (NVL) lumen~     will reproduce the BB physiology by accelerating the second phase of lung deflation and~     giving a better quality of lung collapse compared to usual practice of keeping the~     non-ventilated lung opened to ambient air.~      The main objective is to compare the speed and quality of complete lung deflation occurring~     during OLV with a DLT when the non-ventilated DLT lumen is occluded vs not occluded.~      This randomized study will include a total of 30 patients scheduled for lung resection using~     video-assisted thoracoscopic surgery (VATS). Fifteen patients will compose the experimental~     group (NVL lumen occluded) and 15 other patients will be part of the control group (NVL lumen~     opened to ambient air).~   "
4497|NCT03508037|"~     Strokes are caused by a bleed in the brain and can be life threatening. One common~     consequence is upper limb impairment. This causes stroke patients to be unable to use their~     arms and upper body to do simple tasks such as reaching or grasping. Currently, people with~     stroke undergo rehabilitation, which is usually done through a physical and occupational~     (daily living skills) therapies to improve their mobility (movement) with their upper limbs.~     However, this kind of treatment has limitations and often cannot help patients regain total~     mobility. There are alternative rehabilitation treatments that use new methods and~     technologies that may be able to help patients with stroke. Neuromodulaton therapies using~     brain-computer interfaces (BCI), which connects brain signals directly to a computer, have~     the potential to help patients. This type of therapy uses assistive devices such as~     electrical stimulation (electrical shocks or waves) and robots to help restore function to~     the areas affected by stroke. The aim of this study is to evaluate and the potential benefits~     that can be achieved by using assistive devices in rehabilitation sessions with stroke~     patients.~   "
4498|NCT03508024|"~     This study aims to determine factors related to diagnosis delay for patients with young onset~     dementia (first symptoms before 60 years old) who live in North of France.~   "
4499|NCT03508011|"~     This is a Phase I, first-in-human, open-label, dose-escalation study of IMP4297 administered~     orally once every day to patients with advanced solid tumors for whom standard therapy either~     does not exist or has proven to be ineffective or intolerable. Patients with advanced breast~     cancer, ovarian cancer or prostate cancer are preferred. There are two stages to this study:~     a dose-escalation stage and a dose-expansion stage.~   "
4500|NCT03507998|"~     This is a multi-center, open label, repeat dose, Phase 1 study consisting of a Dose~     Escalation Phase and a Dose Expansion Phase to evaluate safety, pharmacokinetics, and~     clinical activity.~   "
4501|NCT03507985|"~     The aim of the study is to determine if there are attention disorders related to acute~     morphine use in single-traumatized patients and after that the investigators will determine~     whether there are immediate memory problems associated with acute morphine withdrawal in~     single-traumatized patients.~      From a biochemical point of view, the analgesic effects of morphine and the central side~     effects appear to be two different dimensions of the action of morphine, each related to a~     metabolite. Regarding acute attention, it is difficult to differentiate attention deficit~     disorder due to pain or due to morphine.~      Two tests have been validated in the literature to evaluate attention and memory: the 15~     words of Rey and the Stroop Color Word test. The investigators will use these two tests in~     this study.~   "
4502|NCT03507972|"~     Evaluate ankle's ultrasound contribution in the accuracy of ankle's diagnosis of traumatic~     injuries (objectivated by reference's examination : ankle's MRI)~   "
4503|NCT03507959|"~     Research has shown that placebo effects contribute substantially to clinical outcomes. Recent~     evidence suggests that placebos remain effective even if they are openly described as~     placebos (so-called Open-Label Placebos). In this study, the investigators examine components~     of open-label placebos and traditional deceptive placebos in an experimental study~     investigating sadness.~   "
4504|NCT03507946|"~     The purpose of this study is to investigate whether light therapy can help improve plaque~     psoriasis. This is a study based on a new medical device. The device produces its light from~     light emitting diodes. This type of technology has been used for several years in the~     treatment of other skin conditions. However, the investigators want to study the effect of a~     combination of very specific wavelengths of light on reducing the signs and symptoms of~     plaque psoriasis.~      The Investigators are looking to recruit 25 volunteers from the general population between~     the ages of 18 and 65 years old with mild to moderate plaque psoriasis and who are otherwise~     healthy. The light treatments are 5 times a week for 12 weeks and the treatment is~     self-administered at home. Each treatment is 15 minutes. The total duration of the study is~     16 weeks.~      This is a controlled trial. This means that the volunteer will treat one plaque with the~     light therapy device and the other plaque will remain untreated for the period of the study.~   "
4505|NCT03507933|"~     Villo-nodular synovitis can affect the joints, bursae or tendon sheaths. This condition is~     rare, with 1.8 cases per million inhabitants. The hip is affected in 3.6 to 18.1% of cases.~     The age of predilection is between 30 and 50 years old and this condition is rarely described~     in children.~      Two articles report a case of villous-nodular synovitis of the child's hip. Surgical~     treatment by resection seems to be consensus but various adjuvant treatments are also~     proposed. A case of villous-nodular synovitis of the hip in children was treated without~     surgical intervention. The main objective of this study was to evaluate the efficacy of~     surgical treatment of villous nodular synovitis of the hip in children.~   "
4506|NCT03507920|"~     This study investigates the effects of spinal mobilizations on neck symptoms and sympathetic~     nervous system activity in people with neck pain.~   "
4507|NCT03507907|"~     When the literature is examined, there is study investigating the effect of mulligan~     mobilization technique on older adults with neck pain. This study aims to investigate the~     effect of mulligan mobilization technique on pain, range of motion, functional level,~     kinesiophobia, fear of movement, depression and quality of life in older adults with neck~     pain.~   "
4511|NCT03507855|"~     This project will investigate whether reduction in ambient light and elimination of noise~     during induction and emergence from anesthesia influences the response time of the anesthesia~     provider to auditory and visual alarms when compared to a standard operating room. In~     addition, the investigators will assess the cumulative level of noise exposure that providers~     experience during the perioperative period.~   "
4512|NCT03507842|"~     This trial is a single-center, non-blind, two-arm randomized prospective controlled trial to~     compare the effectiveness of two induction chemotherapy regimens (high-dose cytarabine plus~     daunorubicin [HDAC] vs. cytarabine plus high-dose daunorubicin [AD]) in acute myeloid~     leukemia (AML). The primary hypothesis of the study is that AD is superior to HDAC in terms~     of event-free survival (EFS, time from registration to induction failure, relapse, or death).~   "
4513|NCT03507829|"~     This study aims to assess the effects of early basal insulin therapy in previously~     non-diabetic de novo kidney transplant patients in reducing the incidence of new onset~     diabetes in particular and abnormal glucose metabolism in general during subsequent~     follow-up.The ITP NODAT study should be seen in connection with the Vienna SAPT-NODAT study~     (clinicaltrials.gov record number: NCT01680185), as for the final analysis, the data yielded~     from the three arms in those two studies will be used for an pooled analysis.~   "
4514|NCT03507816|"~     The purpose of this study is to examine the epidemiology of TB MR in Strasbourg and evaluate~     the second-line anti-tuberculosis treatments effectiveness, and the relevance and adequacy of~     the treatments with WHO recommendations. During years 2006-2016, all new cases of MDR TB or~     XDR TB diagnosed Strasbourg University Hospital will be included in the study (22 cases).~     Data were collected from the Center for Tuberculosis Control (CLAT) records, the patient's~     medical records.~   "
4515|NCT03507803|"~     Individuals with chronic ankle instability (CAI) have demonstrated altered gait patterns.~     Gait training may be necessary to address these alterations as protocols focusing solely on~     strength or balance have not been shown to impact walking gait. Biofeedback about the foot~     position during walking may help improve gait biomechanics. The purpose is to determine~     whether a 4-week rehabilitation program that includes biofeedback has beneficial effects on~     self-reported function and ankle gait kinematics compared to rehabilitation alone in people~     with CAI. The design is a single-blinded randomized controlled trial. Participants will~     complete baseline self-reported function questionnaires and walking gait trials and then be~     randomized to complete 4- weeks of supervised rehabilitation with or without audiovisual~     biofeedback. Follow up emails will ask for participant information about ankle health and to~     complete questionnaires about their ankle for 6 months and 12 months after completing~     rehabilitation.~   "
4516|NCT03507790|"~     This is a multi-center, randomized, double-blind, placebo-controlled, parallel group 36 week~     multicenter Phase 2 study of two doses of CT1812 in adults with mild to moderate Alzheimer's~     Disease (AD).~   "
4517|NCT03507777|"~     The objective of this clinical investigation is to demonstrate the superiority of an Optical~     Coherence Tomography (OCT)-guided stent implantation strategy as compared to an~     angiography-guided stent implantation strategy in achieving larger post-PCI lumen dimensions~     and improving clinical cardiovascular outcomes in patients with high-risk clinical~     characteristics and/or with high-risk angiographic lesions.~   "
4518|NCT03507764|"~     The principal objective of this study is to determine if the provision of a treadmill~     workstation in an emergency medical services (EMS) dispatch center increases the number of~     steps that participants make daily within 6 months compared to the usual working conditions.~      The investigators hypothesized that the provision of a treadmill workstation with a slow~     walking could increase the number of daily steps and decrease days of leave, musculoskeletal~     disorders without decreasing the dispatch quality.~   "
4519|NCT03507751|"~     Assessment of meropenem plasma concentration in critically ill patients who require CRRT~     (continuous renal replacement therapy). A standard dose of meropenem is administered, i.e. 1~     gram every 8 hours.~   "
4520|NCT03507738|"~     A study to investigate the safety and reactogenicity of MT-5625 independently in adults aged~     18-35 years, toddlers ages 12-24 months, and infants aged 6-10 weeks~   "
4521|NCT03507725|"~     There is a fundamental need for novel study designs that can improve patient understanding~     during informed consent, encourage~      This is a pilot study and a novel approach to clinical trials, testing the feasibility and~     acceptability of two-stage consent in the context of a trial integrated into routine clinical~     practice. The investigator will use, as a model, a trial of a brief mind-body intervention)~     with guided imagery for procedural pain at the time of prostate biopsy. In the design,~     patients will first be approach for consent to 1) have their routinely collected clinical~     data used for research purposes and 2) be randomly selected to be offered an intervention to~     improve the experience of prostate biopsy. Only patients randomized to the experimental arm~     will be informed about the benefits and harms of the intervention and will sign a second~     consent for the experimental treatment.~   "
4522|NCT03507712|"~     Overaction of the inferior oblique (IO) muscle is a commonly observed component of childhood~     strabismus, and is often seen combined with other ocular deviations. It manifests with~     excessive elevation of the affected eye in adduction, and may cause a pattern strabismus and~     vertical deviation of the affected eye. IO overaction (IOOA) may be primary or secondary to~     superior oblique underaction, is often bilateral, and may be symmetrical or asymmetrical.~      Surgical management of the overacting IO muscle is often required to achieve ocular~     alignment. The most commonly performed IO muscle weakening procedures are IO myectomy and~     graded IO recession. The surgical decision is primarily based on degree of overaction of the~     IO muscle. Various studies have compared the two IO weakening procedures and have reported a~     similar success rate for both procedures.~      The aim of this study is to compare the effect of two IO weakening procedures (symmetrical vs~     asymmetrical myectomy or graded recession) in normalizing the IOOA, obtaining vertical~     alignment and collapse of pattern, when employed in the treatment of asymmetrical IOOA.~   "
4523|NCT03507699|"~     A single institution study to evaluate the safety and tolerability of the combination~     treatment of nivolumab, ipilimumab, CMP-001 and radiosurgery in patients with metastatic~     colorectal cancer with liver metastases.~   "
4524|NCT03507686|"~     This is a multi-centre, open-label, prospective, two-period, interventional safety study of~     bilateral use of AAV2-REP1 in adult male subjects with genetically confirmed CHM.~   "
4525|NCT03507673|"~     Rationale:~      The hormone progesterone has different functions. In pregnancy, it is vital for maintenance~     thereof. In early pregnancy, progesterone is synthesized by the Corpus luteum (CL). Its~     production shifts from the CL to the placenta after several gestational weeks. This process~     is termed luteoplacental shift. Still, the exact time point of the luteoplacental shift~     remains unknown. Furthermore, the characteristics of placental progesterone increase and its~     relevance for the course of pregnancy has not been studied so far.~      Furthermore, recent studies have shown an influence of abnormal vaginal microbiota on the~     likelihood to achieve and maintain pregnancy. Little is known about possible crosslinks~     between endocrinology and vaginal microbiota which is why this study aims to investigate~     possible associations of such kind.~      Objective:~      The primary objective of this study is to evaluate the time point of the luteoplacental shift~     in patients achieving pregnancy after transfer of cryopreserved embryos subsequently to~     IVF/ICSI cycles. Secondary objectives are to study the characteristics of the placental~     progesterone increase and its function as a predictor of the course and development of~     pregnancies and to study vaginal microbiota at baseline and changes associated with shift~     into luteal phase and early pregnancy and how this potentially relates to pregnancy outcome.~      Study Design:~      Prospective, multi-center, observational clinical cohort study. For the primary objective,~     data from a single center will be also be retrospectively analyzed.~      Study population:~      Female patients aged 18 to 45 years undergoing transfer of embryos after freezing and thawing~     2PN oocytes or embryos.~      Interventions: Blood withdrawal, vaginal swabs and endocrine and microbiom analyses.~      Study parameters/endpoints:~      The main parameter is time point of progesterone increase in pregnancy in relation to initial~     progesterone levels by pregnancy status. Secondary, slope and magnitude of placental~     progesterone increase and its relevance as a predictor for the course and development of~     pregnancies/babies. Furthermore, vaginal microbiota of women undergoing embryo transfer and~     of women in early pregnancy are parameter of this study.~   "
4526|NCT03507660|"~     The aim of this study is to compare the effectiveness of different verbal instruction on~     pelvic floor muscle contraction among males. Pelvic floor contraction will be measured via~     ultrasound.~   "
4527|NCT03507647|"~     The current study will be a randomized controlled trial (RCT) investigating the clinical and~     cost-effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) as an adjunct to usual care,~     versus usual care alone, in reducing depressive symptoms in patients with bipolar disorder.~     Outcome measures include depressive, (hypo)manic and anxiety symptoms, risk of~     relapse/recurrence, functioning and mental health/well-being. The study also aims to explore~     possible working mechanisms such as improvements of mindfulness and self-compassion skills.~     The study will have a follow-up duration of 15 months from baseline.~   "
4528|NCT03507634|"~     This study compares the intraoperative opioid free anesthesia approach in laparoscopic~     bariatric surgery to a conventional opioid- based anesthesia. Half of participants will~     receive opioid free anesthesia with dexmedetomidine, lidocaine and ketamine while the other~     half will receive opioid based anesthesia with fentanyl, remi-fentanyl and ketamine~   "
4529|NCT03507621|"~     Patients in the study will be grouped as 1st group Propofol, 2nd Group~     Sevofluran.Preoperative blood will be taken from the patients and cortisol, acth, glucagon,~     aldosterone, PGE2, CRH will be studied. During the operation, the patient's systolic blood~     pressure, diastolic blood pressure, mean arterial pressure, heart rate, oxygen saturation~     will be followed. Analgesia will be provided according to the body movements of the patient~     and VAS measurement will be performed. The patient's pain will be assessed by the VAS (Visuel~     Analogue Scale) scoring system and during the first hour postoperatively after the patient's~     consciousness is complete . Hormones such as cortisol, acth, glucagon, aldosterone, PGE2, CRH~     will be studied biochemically in the follicular fluid and blood of the patient~     postoperatively. The aim of in the study is to compare the effect of propofol and sevoflurane~     routinely applied in IVF centers on postoperative pain scores and stress hormones in blood~     and follicular fluid in a painful and stressful application of egg collection~   "
4530|NCT03507608|"~     This is a prospective, single-center, two-phase study to assess the efficacy of single~     pulsed-dose flutamide in creating double strand breaks (DSBs) in prostate cancer within~     patients receiving central androgen suppression and brachytherapy.~   "
4531|NCT03507595|"~     This study aims to use the new molecular probe 18F-PSMA for the diagnosis,staging ,recurrence~     monitoring and evaluation of the prostate cancer.By compared with the conventional imaging~     methods (whole body bone scintigraphy and MRI) and molecular imaging methods (11C-choline~     PET/CT),we hope to find the advantages of 18F-PSMA PET/CT in the diagnosis and metastases of~     prostate cancer, and lay the foundation for the further clinical transformation.~   "
4532|NCT03507582|"~     Children with hemophilia are exposed to intravenous (IV) procedures that cause pain/anxiety~     and distraction methods can be employed to improve the patient experience. Three-dimensional~     virtual reality (VR) environments can reduce distress related to procedures. To be utilized~     in a clinical setting, however, these devices must address infection control concerns and fit~     pediatric patients. Additionally, for use in hemophilia care, environments should encourage a~     subject to keep their hands/arms still to facilitate procedures. Nursing orchestration of the~     VR environment via an iPad dashboard has the potential to increase feasibility and acceptance~     by patients, families and providers of the VR experience without disrupting routine clinical~     care.~   "
4533|NCT03507569|"~     This is a single dose (SD), non-randomized, open-label, adaptive, parallel group study with~     the purpose of investigating the occupancy of alpha5-containing GABAA receptors by RO7017773~     in healthy participants.~   "
4534|NCT03507556|"~     This clinical study aims to investigate the predictability of revascularization procedure of~     immature necrotic human permanent teeth with apical periodontitis. The quality of root~     development (thickness and length) will be assessed radiographically.~   "
4535|NCT03507543|"~     This is a phase 1, First-In-Human, open label study, trialing a new PARP (poly-ADP ribose~     polymerase) inhibitor medication IMP4297 in participants with advanced solid tumour.~   "
4536|NCT03507530|"~     For ambulatory children with DMD, physiotherapy is aimed at protecting ambulation, improving~     motor performance to the best level and increasing quality of life. The investigators think~     that the treatment of children with Duchenne Muscular Dystrophy may become more effective~     with physiotherapy programs based on the comprehensive physiotherapy evaluation results,~     including the evaluation of fear of falling. This study investigates the fear of falling in~     children with Duchenne Muscular Dystrophy and questioning whether their fear of falling~     affects their quality of life and their physical performance.~   "
4537|NCT03507517|"~     To reduce the incidence of stroke and standard the treatment of stroke in Liaoning Province,~     the present study should be conducted.~   "
4538|NCT03507504|"~     The treatment of Behavioural and Psychological Symptoms of Dementia (BPSD) continue to raise~     difficult problems. Both the pharmacologic and non-pharmacologic therapies often fail to~     achieve the expected results. The aim of this study is to assess the short- and long-term~     efficacy of an intervention, the Special Care Unit for patients with BPSD (SCU-B), already~     implemented in some countries but not validated so far, as well as its cost-effectiveness~   "
4539|NCT03507491|"~     This is a research study for people who have a solid tumor that was not effectively treated~     by conventional therapy or for which there is no known effective therapy. This is a phase I~     study of a drug called nab-paclitaxel used together with gemcitabine. Gemcitabine and~     nab-paclitaxel will be given intravenously, once a week for 3 out of 4 weeks, for a 28-day~     cycle.~      The goals of this study are:~        -  To find the highest dose of nab-paclitaxel that can be safely given in combination with~          gemcitabine without causing severe side effects~        -  To learn what kind of side effects nab-paclitaxel given in combination with gemcitabine~          can cause~        -  To learn more about the pharmacology (how the body handles the drug) of nab- paclitaxel~          given in combination with gemcitabine~        -  To evaluate tumor tissue for levels of certain proteins that may help with predicting~          who will benefit most from treatment with nab-paclitaxel~        -  To determine whether nab-paclitaxel given in combination with gemcitabine is a~          beneficial treatment for relapsed and/or refractory solid tumors~   "
4540|NCT03507478|"~     The primary objective of this trial will be to demonstrate the ability of a 3/4 length foam~     insole to provide relief from pain due to plantar fasciitis or general heel pain when used in~     footwear over a 4-week period of time~   "
4541|NCT03507465|"~     Patients with ER+/HER2− breast cancer (presumably the luminal A subtype) could potentially~     avoid the standard chemotherapy use. Letrozole Plus Low-Dose Metronomic Capecitabine may~     offer similar efficacy and less toxicity to standard chemotherapy in ER+/HER2− breast cancer~     patients.~   "
4542|NCT03507452|"~     The primary objective of this study is, to determine the safety, tolerability, maximum~     tolerated dose (MTD) or maximum feasible dose of BAY2287411 Injection in patients with~     epithelioid malignant mesothelioma and serous ovarian cancer~   "
4543|NCT03507439|"~     The study aims to explore two marketed devices providing a multimarker monitoring including~     physical activity under real-life conditions in patients with heart failure with preserved~     ejection fraction (HFpEF) and with heart failure and reduced ejection fraction (HFrEF). It~     aims to identify potential new endpoints for future HFpEF trials by exploring clinically~     relevant changes over time and correlations/associations with conventional endpoints such as~     the six minute walking distance (6MWD), biomarkers and clinical events. Furthermore, it aims~     to address the challenges and feasibility of implementing device based measurements under~     real-life conditions.~   "
4544|NCT03507426|"~     This study compares the efficacy and safety of two techniques, retrobulbar block versus~     intra-operative ketamine infusion, for control of post-operative pain occurring in patients~     undergoing ocular enucleation or evisceration performed under general anesthesia.~   "
4545|NCT03507413|"~     A prospective randomized, double blind, placebo-controlled, safety and efficacy study of~     metformin as add-on therapy in abdominal aortic aneurysm (AAA)~      OBJECTIVES Primary Objective~        -  To demonstrate treatment efficacy of metformin in AAA in comparison to placebo or active~          comparator, as measured by growth of the AAA maximum diameter at 12 months Secondary~          Objectives~        -  To asses inflammatory cytokines and parameters of neutrophil activation in AAA in~          response to metformin treatment by glucose~        -  insulin~        -  IL-6~        -  markers of neutrophil activation (MPO, elastase, NGAL)~   "
4546|NCT03507400|"~     To evaluate the effect of Introvision, a mental and emotional self-regulation-technique~     developed by Angelika C. Wager, as migraine preventative compared to a waiting list group.~   "
4547|NCT03507387|"~     Spinal anesthesia is the preferred anesthesia method in cesarean section to provide~     satisfactory analgesia and muscle relaxant with less impact on respiratory system. However,~     hypotension often occurred due to the block of sympathetic nerve, causing maternal decline of~     frontal lobe oxygenation, nausea vomit and the decrease of uteroplacental perfusion. Several~     measures are used to prevent or treat hypotension caused by spinal anesthesia: prehydration,~     limb compression, left lateral tilt of operation tables or usage of vasopressors. In the past~     decade, the most recommended vasopressor to prevent or treat hypotension in spinal anesthesia~     in cesarean section was phenylephrine, an α-adrenergic receptor, maintaining maternal blood~     pressure and fetal acid-base state. In clinical work, there are two ways to use phenylephrine~     : intravenous method with less onset time (several seconds and duration (20 minutes) and~     intramuscular method with longer onset time (15-20 minutes) and duration (1 hour). Many~     trials demonstrated the protective effect of preventive intravenous phenylephrine on maternal~     hemodynamics and neonatal acid-base status. However, few trials reported the effect of~     preventive intramuscular phenylephrine on cesarean section under spinal anesthesia.~   "
4548|NCT03507374|"~     This will be a randomized double blind placebo-controlled pilot study using a repeated~     measures design in which participants with acute ischemic stroke and intracranial~     atherosclerotic disease are randomized to either drug or placebo.~   "
4549|NCT03507361|"~     MYDA-MUSIC study is a randomized, double blind (operator and analyst) study performed in San~     Filippo Neri Hospital, Roma, Italy and in Di Venere Hospital, Bari, Italy. The planned study~     duration is 12 months. The objectives are to assess the effects of heart-rate-variability~     based music on the incidence and magnitude of peri-procedural myocardial damage caused by~     coronary angioplasty in stable patients. 443 patients with chronic stable angina scheduled~     for a coronary angiography and possible ad hoc angioplasty will be randomized to receive~     music or dumb earphones.~   "
4550|NCT03507348|"~     Kidney transplantation is the best renal-replacement in the setting of end-stage renal~     disease. However, some transplant candidates have developed anti-HLA alloantibodies (human~     leukocyte antigen). When they are numerous and when their strength assessed by mean~     fluorescence intensity (MFI) is high it is very complicated to find-out a suitable kidney~     allograft against which the recipient has a negative cross-match. In such a case the only~     hope for the patient is desensitization therapy, whereby the treatment will decrease anti-HLA~     alloantibodies below a threshold, i.e. MFI < 3,000, enabling kidney transplantation without~     risking antibody-mediated rejection. Desensitization relies on i) apheresis technics in order~     to withdraw circulating anti-HLA antibodies, and ii) immunosuppression, i.e. rituximab or~     tocilizumab, targeting B-lymphocytes, and tacrolimus/mycophenolic acid/steroids targeting~     T-cells. The type of apheresis is guided by the pre-desensitization MFI of anti-HLA~     alloantibodies, e.g. double filtration plasmapheresis or semispecific immunoadsorption.~     Likely the choice between rituximab and tocilizumab depends also on predesensitization~     anti-HLA antibody MFIs. At the end of the desensitization process, the patient will be able~     to get a kidney transplant either from a live-donor or from a deceased donor.~   "
4551|NCT03507335|"~     Aims Approximately 20-25% of strokes are of cardioembolic origin, atrial fibrillation (AF)~     being a significant cause of cardioembolic strokes. AF is often symptomless and intermittent,~     making its detection a clinical challenge. Currently the golden standard for diagnosis of AF~     is by 12-lead electrocardiogram (ECG) or any other ECG-strip.~      The primary aim of the study is to assess the potential of chest strap as an ECG monitor~     especially in arrhythmia detection by cardiologist and algorithm. The secondary aim is to~     assess potential of photoplethysmography (PPG) based device for arrhythmia detection.~   "
4552|NCT03507322|"~     This study is focused on analysing the application of ultrasound scanning techniques as new~     biomarkers in reproductive medicine. Those biomarkers are based on the analysis of ultrasound~     texture in different areas of uterine tissue, using 2D/3D ultrasound scanning. Investigators~     will use the algorithm Text® to analyse the ultrasound texture of the endometrium and~     myometrium. The aim of the project is to study if it is possible to obtain measurable,~     objective and reproducible data in healthy volunteers which can be used to predict pregnancy~     and determine the best moment to perform embryo transfer in assisted reproductive technology~     (ART) cycles~   "
4553|NCT03507309|"~     The NHIC Cardiovascular Project is an observational, multi-centre and longitudinal study of~     clinical data from collaborating hospitals. A dataset of the longitudinal record for patients~     who presented with a suspected acute coronary syndrome, characterised by the request of a~     troponin test, has been developed (NHIC-Troponin Study).~   "
4554|NCT03507296|"~     This study will test the within and between day variability of spinal kinematics and trunk~     muscle activity in healthy subjects and chronic low back pain patients during various~     daily-life activities.~   "
4555|NCT03507283|"~     15 eyes of 15 patients with primary double-headed pterygia that underwent vertical split~     conjunctival autograft pterygium surgery were retrospectively reviewed. All patients had~     primary double-headed pterygia. Recurrence was defined as fibrovascular proliferation over~     the limbus onto the cornea.~      Vertical split conjunctival autograft using fibrin glue is an effective technique with good~     cosmetic results and low to no recurrence for primary double head pterygia treatment.~   "
4556|NCT03507270|"~     Predictable values of the 1-hour algorithm for estimating the concentration of troponin using~     highly sensitive reagents are 98-100% for excluding myocardial infarction (MI) and 75-80% for~     identifying this pathology. Such algorithms are developed for the rapid confirmation or~     exclusion of myocardial infarction without ST-segment elevation and, when combined with~     clinical data and electrocardiogram, are used to assess the risk of adverse course of disease~     and to contribute to decision making about expediency of stay in the intensive therapy unit~     and early discharge.~      In mid-1980s, a new marker of myocardial damage was proposed, namely: fatty-acid-binding~     protein (FABP). However, the diagnostic value of FABP cannot be interpreted unambiguously~     because of insufficient number of studies determining the sensitivity and specificity of the~     test in various manifestations of acute coronary syndrome (ACS).~      Available literature presents a wide range of reference values of FABP for MI diagnosis.~     Reference value ranges are proposed by manufacturers of diagnostic kits based on previous~     studies. In addition, there is no information about the FABP changes during the first three~     hours of the disease, as well as there are no data on diagnostic value of changes in this~     indicator (∆) in patients with ACS without ST-segment elevation. These considerations~     provide rationale and support novelty of the planned pilot study.~   "
4557|NCT03507257|"~     The Longitudinal Early-onset Alzheimer's Disease Study (LEADS) is a non-randomized, natural~     history, non-treatment study designed to look at disease progression in individuals with~     early onset Alzheimer's disease (EOAD). Clinical/cognitive, imaging, biomarker, and genetic~     characteristics will be assessed across two cohorts: (1) individuals with EOAD and (2)~     cognitively normal (CN) control participants.~   "
4558|NCT03507244|"~     Intrathecal chemotherapy is one of the most important treatment modalities for leptomeningeal~     metastasis of solid tumors. In the previous retrospective study, it has been proved that~     concurrent radiotherapy and intrathecal methotrexate for leptomeningeal metastasis from solid~     tumors with adverse prognostic factors showed great effectiveness and safety. The preliminary~     results of investigators' current prospective clinical study (Involved-field Radiotherapy~     Combined With Concurrent Intrathecal-methotrexate Versus Intrathecal-Ara-C for Leptomeningeal~     Metastases From Solid Tumor: A Randomized Phase II Clinical Trial. ClinicalTrials.gov~     identification number: NCT03082144) also showed that the regimen of concurrent intrathecal~     chemotherapy and radiotherapy may serve as an optimal therapeutic option for treatment of~     leptomeningeal metastases from solid tumors. Pemetrexed is a newer multitargeted antifolate~     which has shown activity in various tumors. In investigators' current study (Intrathecal~     Pemetrexed for Recurrent Leptomeningeal Metastasis From Non-small Cell Lung Cancer: A~     Prospective Pilot Clinical Trial. ClinicalTrials.gov identification number: NCT03101579), the~     regimen of intrathecal pemetrexed with folic acid and vitamin B12 supplementation may provide~     higher effectiveness and safety for recurrent leptomeningeal metastasis from non-small cell~     lung cancer. Therefore, the purpose of the study is to evaluate the tolerability, safety and~     effectiveness of intrathecal pemetrexed combined with involved-field radiotherapy as the~     first line treatment in patients with leptomeningeal metastases from malignant solid tumors.~   "
4559|NCT03507231|"~     The investigators will test the hypothesis that the control (no incentive) condition will~     have the lowest vaccination rate, the main task condition will have a significantly higher~     vaccination rate while the indirect condition will have the highest vaccination rate.~      Participants will be randomly assigned to one of the three message conditions and their~     vaccination records obtained from the university Occupational Health Department.~   "
4586|NCT03506880|"~     Project MADD was designed to attempt to curb the alarming trends related to drunk driving and~     to move the field forward by testing a brief parent-intervention's ability to change~     adolescents' drinking, impaired driving, and riding with impaired driver behaviors. The aim~     of this project is to provide an easy-to-implement and low-cost alternative parent-based~     intervention that can be widely disseminated to address this important public health problem.~   "
4843|NCT03503513|"~     A cross over study evaluating the efficacy of intravesical gentamicin on the occurrence rate~     of urinary tract infections and bladder complications in patients after spinal cord injury~     (SCI), and to assess its effectiveness in promoting overall quality of life (QOL), community~     living, and participation.~   "
4560|NCT03507218|"~     Background:~      PANS is an illness that comes on suddenly in children. The full name is Pediatric Acute-Onset~     Neuropsychiatric Syndrome. It can cause sudden obsessive-compulsive behaviors. It can also~     cause children to suddenly restricte their food intake. Researchers want to learn more about~     children with PANS. They also want to learn more about the illness.~      Objective:~      To study some disorders of behavior and emotion that start in childhood.~      Eligibility:~      Children 3 14 years old who have had severe obsessive-compulsive symptoms or food restriction~     start quickly~      Design:~      Parents will answer questions. The topics include:~      Their child s medical history~      Their child s physical and mental health~      Their family history. The focus will be on neurodevelopmental and psychiatric conditions. A~     family tree will be drawn.~      Participants will have a physical exam.~      Participants may take tests on paper or computer. These will focus on thinking, memory, and~     behavior.~      Participants and parents will give a blood sample.~      Participants will have magnetic resonance imaging (MRI). A strong magnetic field and radio~     waves take pictures of the brain. Participants will lie on a table that slides in and out of~     a metal scanner.~      Participants may have photos or videos taken.~      Participants may have other tests. These may include heart tests, sleep tests, and lumbar~     puncture.~      Sponsoring Institute: National Institute of Mental Health~   "
4561|NCT03507205|"~     The objective of this study is to evaluate the long-term efficacy and safety of coronary~     stenting with the various types of drug-eluting stents (DES) and to determine clinical device~     and procedural success during commercial use of DES in the real world.~      The investigators will compare EES (Xience V/Promus and Xience Prime), SES (Cypher), ZES~     (Resolute Integrity, Endeavor Resolute, Endeavor), and BES (Biomatrix, Biomatrix Flex, and~     Nobori).~   "
4562|NCT03507192|"~     The prevalence of dementia is approximately 5-10% in the elderly who are over 65 years of~     age. In Korea, the prevalence of dementia among elderly people aged 65 and over was 9.18% in~     2012, and the number of patients with dementia was estimated to be 540,755 (155,955 for male,~     384,800 for female). The number of patients with dementia will be doubled every 20 years~     until 2050, which is estimated to be 840,000 in 2020, about 1.27 million in 2030, and 2.71~     million in 2050. Alzheimer's disease is the most common cause of dementia, accounting for~     55-70% of all dementia. Major risk factors include age, genetic factors, apolipoprotein E~     gene, female and brain trauma, but stress is also associated with increased risk of~     Alzheimer's disease.~      Stress can be present anywhere in our daily lives, and stress can energize life, but if~     people are exposed to stress for a long time, they may develop physical symptoms. Severe and~     long-term stress can cause or exacerbate diseases such as angina, stroke, hypertension,~     diabetes, tension headache, back pain, irritable bowel syndrome, asthma and arthritis.~     Studies about the relationship between stress and Alzheimer's disease have shown that the~     corticotrophin releasing factor secreted when exposed to stress can increase brain toxic~     protein such as beta amyloid plaques that are known to be responsible for dementia.~      There are various ways to overcome stress, like meditation, yoga and relaxation training~     methods that individuals can do at home. Relaxation training methods include relaxation using~     breathing and progressive muscle relaxation. Progressive muscle relaxation therapy stabilizes~     anxious psychology by stretching and relaxing several muscles of the body in turn. Muscle~     relaxation promotes arterial and venous flow, lymphatic flow, reduces edema of muscles and~     connective tissues, and improves organ function to aid homeostasis.~      Muscle relaxation has been reported to be effective in alleviating anxiety and agitation~     symptoms in patients with dementia, but no studies have examined the effects of muscle~     relaxation therapy on cognitive function changes.~      Therefore, the purpose of this study is to compare and validate the improvement of cognitive~     function in patients with mild cognitive impairment over the age of 50 years and patients~     with early Alzheimer's dementia after performing muscle relaxation machine massage regularly.~   "
4563|NCT03507179|"~     Nineteen patients will be selected from the clinic following the inclusion and exclusion~     criteria. Each one of them will receive two dentures. The first denture will be a~     conventional complete denture while the second denture will be a complete denture made by~     Rapid prototyping method.~      For both groups, a preliminary impression will be made & after pouring the primary~     impression, self-cured acrylic resin trial denture bases with a wax rim will be constructed~     on the primary casts for the upper & lower arches for a jaw relation record. A facebow record~     will be used to mount the upper cast, while the lower cast will be mounted using a centric~     relation record. Setting of artificial teeth will be performed, then the denture will be~     tried in patient`s mouth. Functional impression will be taken during the try in stage which.~      For the first denture, the functional impression will be poured in normal way to obtain the~     master cast. Then Processing will be done in normal way and the denture will be finished and~     polished and delivered to the patient.~      But for the second denture construction CBCT scanning of the try in with the functional~     impression will be done to obtain STL file then denture base manufacturing will be done by 3D~     printing.~      For group A and group B Retention will be measured for the upper denture immediately, with a~     wash out period one month between the two dentures.~   "
4564|NCT03507166|"~     This study will evaluate the efficacy and safety of intravenous RC48-ADC in patients with~     local advanced or metastatic HER2 positive endothelial cancer.~   "
4565|NCT03507153|"~     Evaluation of the muscle activity of masseter in tooth borne partial denture wearers (class~     III modification 1 Kennedy's classification) with two different denture base materials~     (Breflex and PEEK) by means of electromyograph.~   "
4566|NCT03507140|"~     Many studies describe the relationship between microbiota alteration and the occurrence of~     metabolic, alcoholic or inflammatory liver diseases. Nevertheless, the modifications of~     microbiota during liver transplantation (LT) as well as its implication are poorly studied.~     Similarly, only the intestinal microbiota is studied in this context, and no data are~     available on the biliary microbiota, even if it is known that bile microbiota can interfere~     with hepatobiliary diseases.~      This study proposes a clinical and biological in-depth follow-up with multiple sampling of~     liver transplanted patients to study biliary and intestinal microbiota alterations along LT,~     as well as bile acids metabolism in corresponding fluids.~      Indeed, in recipient samples as saliva, blood, urine, and feces can be taken before LT, and~     surgeons can easily perform bile sampling during LT. In donors all samples can be taken~     during liver removal. This offers the opportunity to have a microbiotic landscape of~     individuals without liver disease (donor), and patients suffering from a chronic liver~     disease or a liver cancer before and after transplantation.~      Also, in Grenoble University hospital, in case of biliary anastomotic incongruence, a biliary~     stent is placed during LT in 60% of recipients. This stent is removed by endoscopic~     retrograde cholangiopancreatography (ERCP) within 6 months after LT, offering a second~     opportunity to obtain bile samples in transplanted patients, after the early post-LT period.~     Patients who do not require a biliary stent will also be included for the study of secondary~     objectives, as intestinal microbiota is very poorly characterized in liver transplanted~     patients too. A portion of the patients without biliary stent, may also develop an~     anastomotic biliary stricture requiring an ERCP. If this ERCP is realized within the~     follow-up period of the study, the patient will also be included in the primary objective of~     the study.~      These multiple and sequential samples will allow a complete analysis of microbiota changes in~     LT patients and aim to answer to 3 questions:~        1. What are the modifications of intestinal and biliary microbiomes during LT?~        2. What is the influence of bile acids' composition on intestinal and biliary microbiota?~        3. What are the relationships between microbiome alterations and the emergence of LT~          complications?~   "
4613|NCT03506529|"~     Questionnaire to be completed by patients coming for PET to identify the predictive factors~     of physiological hypermetabolism of the anal canal~   "
4894|NCT03502850|"~     ASK120067 Tablets is a Epidermal Growth Factor Receptor (EGFR) mutation selective Tyrosine~     Kinase Inhibitor which can efficient suppress the EGFR T790M drug-resistant mutation tumor~     cell in Xenograft mouse model. This study aims at local advanced or metastatic non-small cell~     lung cancer patients with T790M drug-resistant mutation.~   "
4567|NCT03507127|"~     Schizophrenia is associated with high rates of cigarette smoking and associated morbidity and~     mortality. In this study, smokers with schizophrenia will complete a baseline session and~     then randomized to varenicline (VAR) or placebo (PLA). After 1 week on medication,~     participants will complete a cigarette rating task session. Participants will then undergo a~     72-hr abstinence period in which they will come to the laboratory twice per day and receive~     high-value cash reinforcement contingent upon meeting a strict breath CO abstinence~     criterion. At each visit, they will rate withdrawal symptoms, mood and craving. At the end of~     the abstinence period, they will repeat the cigarette rating task. Participants will return~     to the lab to provide a CO sample 24 hours later, and will text the lab with videos of their~     CO samples for one week. Date and time of smoking relapse will be measured from these~     samples.~   "
4568|NCT03507114|"~     1. To investigate the efficacy and acceptability of a guided internet-delivered~          transdiagnostic intervention targeting repetitive negative thinking for individuals with~          elevated levels of depression and generalized anxiety disorder (mild to moderate~          clinical symptoms) vs a wait-list control group (WLCG).~        2. To investigate the hypothesized mechanism of change: Repetitive negative thinking is~          reduced first, and consequently the clinical symptoms (depression and/or anxiety)~          decrease.~   "
4569|NCT03507101|"~     The goal of this study is to gain important knowledge on the pathogenesis and prognostic~     factors in severe invasive group A streptococcal (GAS) infections, as well as the effects of~     individual characteristics of both the pathogen and the patient on disease severity. The aim~     is to recruit a minimum of 60 patients from Tampere and Turku University Hospitals in 2-3~     years to gather a suitably wide spectrum of manifestations of the disease, and gather~     genetic, transcriptomic and diagnostic data on both the patients and pathogens in an effort~     to further our understanding of the pathogenesis of severe invasive GAS disease.~   "
4570|NCT03507088|"~     Effects of fulvestrant on the ERs may be evaluable by molecular imaging using positron~     emission tomography with the ER-specific FES tracer. In this study we will determine the~     utility of FES-PET in the prediction of response to fulvestrant 500 mg in women with estrogen~     positive metastatic breast cancer~   "
4571|NCT03507075|"~     Directly reinforcing abstinence from alcohol with monetary incentives is an effective~     treatment for alcohol dependence, but barriers in obtaining frequent, verified biochemical~     measures of abstinence limit the dissemination of this treatment approach. The goal of this~     feasibility study is to determine if using technological advancements to remotely,~     accurately, and securely monitor alcohol use with a newly developed breathalyzer is an~     effective treatment that is acceptable to participants. If validated, this treatment approach~     has the potential to facilitate the dissemination of an effective, evidence-based treatment~     for alcohol dependence to a broader population whose treatment needs are not currently being~     adequately met.~   "
4572|NCT03507062|"~     The present study will investigate the effect od different crystalloids with increasing~     strong ion difference (SID) on plasmatic pH and urinary electrolytes.~      Every patient will receive a solution with known SID at two different volumes to investigate~     effects of different hemodilution in vivo during general anesthesia.~   "
4573|NCT03507049|"~     Sacroiliac joint fusion versus sham operasjon for treatment of sacroiliac pain. A prospective~     double blinded randomized controlled multicentre study.~   "
4574|NCT03507036|"~     The human skin aging process is characterized by thinning dermis, atrophy of the~     extracellular matrix, and reduced collagen synthesis. Loss of collagen in the dermis is of~     aesthetic concern, as it is the main structural support in the dermis and its loss results in~     skin laxity. Photo-damaged skin, mostly due to UVR, causes degradation of elastic fibers.~     This is histologically seen as disorganized tangles of elastin. Additionally, as humans age,~     skin tends to appear more dry due to its poor hydration and turgor capacity. The use of~     minimally invasive aesthetic treatments in reducing signs of aging has been gaining in~     popularity over surgical treatments in recent years. Several energy types including, laser,~     radiofrequency, infrared, and ultrasound, have been developed for facial rejuvenation. These~     treatments induce controlled thermal damage into the dermis and cause collagen contraction~     and neocollagenesis resulting in skin tightening over several months. For improving~     appearance of other anatomical areas, micro-focused ultrasound has been the preferred method,~     but has shown limited success in tightening the suprapatellar skin.~      As with facial skin aging, the suprapatellar skin loses elasticity with age and begins to~     sag. Noninvasive treatments used for the face may also be used in other anatomical areas to~     produce the same effects of tightening. Minimally invasive bipolar radiofrequency produces a~     controlled thermal injury in a fractional manner without damaging the dermal-epidermal~     junction, epidermis or subcutis. Radiofrequency, unlike lasers, are chromophore-independent~     providing better penetration than lasers, and spare sweat glands, sebaceous glands, and hair~     follicles.~      The Profound System is a bipolar fractional radiofrequency device which uses microneedles and~     thermal heat to stimulate neocollagenesis. Based on the its effect on facial skin, it can be~     hypothesized that bipolar fractional radiofrequency will stimulate similar effect on~     suprapatellar skin, lifting and reducing laxity of the skin in that region.~      This study intends to evaluate the effectiveness of the Profound System on suprapatellar~     skin, which has been FDA approved for treatment of facial wrinkles and improvement in the~     appearance of cellulite. This device is a well studied and frequently used on facial skin,~     however, there are no studies showing its effectiveness elsewhere on the body.~      There are alternative treatments that have been shown to decrease laxity of the suprapatellar~     skin, however, the studies include a small and limited population, and have not produced the~     desired effects in practice. The Profound device may be able to produce clinically~     significant improvement in laxity of the suprapatellar skin.~   "
4575|NCT03507023|"~     Determine if a double-blind, randomized, placebo-controlled clinical intervention, based on a~     dietetic intervention and physical exercise, supplemented with a polyphenolic extract,~     decreases blood pressure in hypertensive volunteers.~   "
4576|NCT03507010|"~     The aim of the LedRad trial is to determine the efficacy and durability of radiotherapy as~     treatment for patients with Ledderhose disease and to compare this to the natural course of~     Ledderhose disease.~   "
4577|NCT03506997|"~     PERSEUS1 is an open-label, single arm, phase II trial evaluating the efficacy of~     Pembrolizumab in metastatic castration resistant prostate cancer (mCRPC) patients (Part A)~     with a biomarker enrichment stage (Part B) if efficacy is shown in part A.~   "
4578|NCT03506984|"~     Participants had randomly divided into two equal groups. Group (A) had received a program of~     high intensity interval training 30-40 minutes three times per week for one month. The~     participant will start cycling slowly for five minute without resistance at the beginning of~     the exercise as warming up, then the active phase will last 20-30 minutes, then decrease the~     speed with no resistance at the end of the exercise as cooling down. Group (B) will receive a~     program of inspiratory muscle training by using the threshold based inspiratory muscle~     trainer for 10-15 minute daily with frequency three times per week for four weeks.~   "
4615|NCT03506503|"~     Nowadays, multiple treatment modalities have been applied clinically to treat androgenic~     alopecia, such as Follicular unit transplantation(FUT), finasteride, platelet-rich plasma~     injection(PRP), etc. In this clinical trial, the investigators aim to analyze the effect of~     nanofat grafting on treating androgenic alopecia in male.~   "
4579|NCT03506971|"~     The PERL project is a research in prevention in perinatality. The objective of this research~     is to offer preventive and regular care at familie's home in the Lunévillois area, while~     integrating it into the existing practices of the maternal and child protection, in the~     framework of a partnership between the PMI (Protection Maternal Infantile) and the child~     psychiatry.~      An innovative prevention device to support the interactions and development of the child will~     be proposed to about sixty families, randomly recruited into the general population.~      If the family agrees to participate, their will benefit from regular home visits by a~     pediatric nurse, accompanied on certain times by a psychologist, for a period of 4 years from~     the birth of the child.~      This home-visits accompaniment, centered on listening and observation, focuses on three~     areas: baby's development, parenthood and parent-child's interactions.~      A longitudinal and comparative evaluation will be carried out with a control group~     recruited according to the same conditions and at the same time as the participants group.~      A parallel research on the processes and mechanism will be carried out in partnership with~     the School of Public Health in order to define and validate the intervention theory (what are~     the mobilized levers produced and how, what are the mechanisms linking the intervention to~     its results), to describe the implementation and the processes involved, and to analyze the~     effects of context, especially social, on processes and results.~   "
4580|NCT03506958|"~     Treatment of fractures and dislocations are generally organized in the hospital setting.~     However, equal care for patients with non-complex fractures or dislocations may be provided~     in general practices. While substitution of trauma care from the secondary to the primary~     care setting is stimulated by the government and insurers, it is unknown what the patient~     satisfaction level is and which determinants affect this patient satisfaction. Therefore, the~     primary objective of this study is to determine the effect of treatment in a general practice~     on patient satisfaction compared to treatment in a hospital. The secondary objectives include~     assessments in quality of life, patient-reported outcomes and cost-effectiveness. Besides,~     results will be discussed using a small focus group consisting of patients (n=15 per group)~     and healthcare providers.~   "
4581|NCT03506945|"~     Caregivers suffer great amounts of distress that significantly impacts their mental and~     physical well-being, yet caregivers' access to quality, evidence-based care is currently very~     limited. The public health significance of the proposed study is that our internet and~     mobile-based web intervention will (1) significantly reduce caregiver distress and improve~     caregivers' overall well-being, and (2) dramatically increase caregivers' access to high~     quality, evidence-based care at relatively low cost.~   "
4582|NCT03506932|"~     This study's overall goal is to investigate methods to improve the acceptability of pulse~     containing foods that provide a health benefit to consumers. The health benefits we are~     testing are post-prandial blood glucose attenuation and appetite related sensations in~     healthy human volunteers.~   "
4583|NCT03506919|"~     This study aimed to develop two poly herbal capsule formulations for arthritis through~     granulation and conduction of their clinical trial in order to achieve quality, efficacy and~     safety. Arthritis is a chronic disease of unknown cause. An inflammatory disease of the~     synovium, it results in pain, stiffness, swelling, deformity and, eventually, loss of~     function in the joints. Despite early detection, current treatment medications are limited in~     their efficacy and are frequently toxic. Many patients look for complementary and alternative~     medicine (CAM) options in coping with this debilitating disease. Research has indicated that~     people suffering from chronic pain, as in arthritis, and those dissatisfied with current~     treatment are very likely to seek alternative treatments, and an estimated 60-90% of persons~     with arthritis use complementary and alternative medicines. Among the most widely used~     treatments are chiropractic and herbal therapies. This growing interest in alternative~     medical practices clearly indicates the need for more thorough investigation into the safety~     and efficacy of herbal medicine. Thousand years of traditional use can provide us with~     valuable guidelines to the selection, preparation and application of herbal formulation. To~     be accepted as viable alternative to modern medicine, the same vigorous method of scientific~     and clinical validation must be applied to prove the safety and effectiveness of a~     therapeutical product.~   "
4584|NCT03506906|"~     Patients suffering chronic hypercapnic respiratory insufficiency (e.g. in chronic obstructive~     pulmonary disease, obesity hypoventilation syndrome) benefit from home mechanical~     ventilation. These patients are complex; and the ventilator´s parameters should be set-up~     according to the underlying disease and particular characteristics. Now, given that the~     non-invasive ventilation therapy is mostly titrated while the patient is awake, problems~     arising while sleeping on the ventilator therapy would remain undetected.~      The sleep studies, such as polysomnography or polygraphy and transcutaneous carbon dioxide~     monitoring could be valuable tools to fine-tune the ventilator's settings. This could foster~     the ventilator´s effectivity and patient satisfaction, thus therapy's adherence. Nevertheless~     the sleep studies are expensive, time-consuming and not widely available.~      The aim of this study is to learn the findings of sleep studies when they are performed on~     stable patients on home mechanical ventilation as part of their routine check-ups. In this~     context, it will be assessed whether the sleep studies' findings lead to a change~     (adjustment) of the ventilator´s therapy. Moreover, this study aims to investigate whether~     the absence of sleep studies would result in missing important events that require an~     adjustment of therapy. The results of this study could provide information that lead to a~     more standardized protocol of follow-up checks of patients on home mechanical ventilation in~     a cost-effective manner.~   "
4585|NCT03506893|"~     The hypothesis is that the Alfapump® strategy would be more effective in terms of QALYs~     generated , and that the cost of Alfapump® device and its implantation will be totally or~     partially offset by the reduction in the number of evacuating parentheses performed and the~     reduction in the number of complications in patients with refractory ascites awaiting liver~     transplantation or not. On the other hand, given the difference in the clinical profiles of~     these two populations (whether or not they are awaiting transplantation), these two~     populations will be study separately~      Evaluation of the medical-economic impact at 1 year of the two therapeutic strategies:~     implantation of Alfapump® versus repeated evacuating paracentesis in cirrhotic patients with~     refractory ascites without scheduled liver transplantation.~   "
8783|NCT03451916|"~     The objectives of this study are to assess the efficacy, safety, and tolerability of PLX-PAD~     intramuscular administration for the treatment of muscle injury following arthroplasty for~     HF.~   "
4587|NCT03506867|"~     Health is a state of complete physical, mental and social well-being, and not merely the~     absence of disease or infirmity (World Health Organization, 1948). Diseases such as HIV/AIDS~     and Hepatitis-C (HCV) thrive in conditions of poverty and marginalization. Research on the~     quality of life of people living with HIV/AIDS reveals that unemployed individuals report~     more depression, anxiety, social isolation, and low self-esteem than employed individuals.~     Moreover, unemployment is a key factor in the contemplation of suicide among people with~     HIV/AIDS. Alternatively, employment among people living with HIV/AIDS is a strong indicator~     of improved quality of life. A finding the study investigators confirmed in a research study~     (PROMPT) supporting 80 members of Ottawa's low income homeless (or at-risk for homelessness)~     People Who Use Drugs reduce (and in some cases quit) smoking.~      PROMPT participants repeatedly stated that boredom and a lack of meaningful social~     connections and employment were major hindrances in their reduction and overall recovery from~     smoking and drug use. With these PROMPT findings, the investigators propose a Community-Based~     Participatory Action project that builds the social capital of 80 participants that identify~     as members of Ottawa and Toronto's low income People Who Use drugs living with or are at-risk~     for HIV/AIDS/HCV. The proposed multi-site project will include life-skills training,~     counseling, health services access (testing and treatment), and education on HIV/AIDS/HCV.~     Most importantly the project will include a poverty reduction intervention that connects~     participants with education opportunities, short-term work and volunteer opportunities. The~     education, work and volunteer opportunities' will be made possible with the support of local~     business owners and networks that support the study's poverty reduction and community~     building elements. The aim of project will be to demonstrate the feasibility and cost of a~     holistic healthcare that encourages a state of complete physical, mental, and social~     well-being.~   "
4588|NCT03506854|"~     This is a Phase 1, Multicenter, Open-Label, Parallel Group Adaptive Pharmacokinetic Single~     Dose Study of ISIS 681257 Subcutaneous Injections in Male And Female Subjects with Normal and~     Impaired Renal Function~   "
4589|NCT03506841|"~     The overall aim of the study is to assess the effect of Cerebrolysin on physical and mental~     development of preterm infants by Denver Scale II at different ages of 5, 7 and 12 months~   "
4590|NCT03506828|"~     Primary hyperhidrosis is a disorder characterized by excessive and chronic sweating in the~     absence of a sweating trigger. The disorder can be severe and interfere with normal daily~     activities of the patients.~      The gold-standard treatment in severe cases of hyperhidrosis is thoracoscopic sympathectomy~     betweenT2 and T4. These procedures are regularly performed in surgical units under general~     anaesthesia which needs special anesthetic considerations which is complex and associated~     with a lot of complications.~      Radiofrequency ablation of the sympathetic chain for treatment of hyperhidrosis is considered~     alternative to thoracoscopic sympathectomy. The procedure is safe, inexpensive and done under~     sedation with local anaesthesia in an outpatient setting, but its success rate is still~     significantly lower than endoscopic sympathectomy.~      The purpose of this study is to determine whether adding phenol 6% in a mixture with glycerin~     will increase the efficacy of fluoroscopy guided radiofrequency ablation of T2, T3~     sympathetic ganglia in hyperhidrosis in comparison to surgery without significant side~     effects to provide safe and effective method rather than surgery.~   "
4591|NCT03506815|"~     Purpose of Pilot Trial To determine the feasibility of conducting a multicentre randomized~     open label controlled trial evaluating the use of prophylactic dose rivaroxaban to prevent~     central venous catheter (CVC) associated venous thromboembolism(VTE) among cancer patients.~      Hypothesis: treatment with low dose rivaroxaban (10mg) will reduce the incidence of upper~     extremity venous thrombosis in a high risk population with cancer and CVC.~      Design:~      This is a pilot interventional study to be conducted at 3 Canadian Centres. The Ottawa~     Hospital, QEII Health Science Centre and University of Alberta Hospital.~      It is an open label randomized controlled trial.~      Consenting participants, meeting eligibility criteria will be randomized at the time of~     enrollment to one of two groups.~      Rivaroxaban 10mg po daily x 90 (+/- 3 ) days OR Standard of Care~      Participants in the treatment arm will have study drug dispensed at Day 1 and take medication~     for 90 days. Follow up visits (in person or phone) will occur at Day 30 (+/- 3 days) and Day~     90 (+/- 3 days) month and 3 months post enrollment. Overall, participants will be followed~     for 3 months. Adverse events will be collected for the first 90 days.~      Outcomes The primary feasibility outcome for the pilot study is the number of participants~     recruited per centre per month. We will obtain baseline details of the patient's type,~     location and treatment of cancer, comorbidities and medications. Secondary feasibility~     outcomes of the pilot study will include, consent rates, loss to follow up, adherence to~     therapy defining 80% or greater medication taken as having good adherence to study drug,~     proportion of screened patients who meet eligibility criteria.~   "
4592|NCT03506802|"~     This phase I trial studies the side effects of NY-ESO-1 TCR engineered peripheral blood~     mononuclear cells (PBMC) and peripheral blood stem cells (PBSC) after melphalan conditioning~     regimen in treating participants with multiple myeloma that has come back or does not respond~     to treatment. The melphalan conditioning chemotherapy makes room in the patient?s bone marrow~     for new blood cells (PBMC) and blood-forming cells (stem cells) to grow. Giving NY-ESO-1 TCR~     PBMC and stem cells after the conditioning chemotherapy is intended to replace the immune~     system with new immune cells that have been redirected to attack and kill the cancer cells~     and thereby improve immune system function against cancer. Giving NY-ESO-1 TCR PBMC and PBSC~     after melphalan may work better at treating multiple myeloma.~   "
4593|NCT03506789|"~     Dexamethasone twice for pain treatment of total knee arthroplasty - A Placebo-controlled,~     randomised, parallel 3-group multicentre trial of one and two doses of dexamethasone for~     postoperative treatment~   "
4594|NCT03506776|"~     Foot self-management is important in preventing diabetic foot ulcers. However, even when~     individuals care for their feet, the signs of inflammation are often missed. A tool that will~     identify inflammation, a sign of initial tissue damage, may be needed. Previous research has~     shown that foot temperature self-monitoring reduced ulcer incidence by providing a warning~     sign of inflammation. However, these studies used an expensive medical thermometer. The~     objectives for this mixed-methods study are: (1) to determine if a foot health intervention~     that utilizes an inexpensive commercially-available infrared thermometer (CAIT) improves foot~     outcomes for individuals with diabetes; (2) to identify factors impacting foot~     self-management; (3) and to explore the participants', family and support persons', and~     healthcare providers' experiences with foot self-management and the intervention. This study~     will have three phases: Phase 1, patients, family and support person, and healthcare~     providers will share their insights regarding foot self-management to inform the~     intervention; Phase 2, a six-month RCT will assess the effectiveness of a CAIT; Phase 3,~     interviews will be conducted with participants, family and support persons, and health~     providers to explore their experiences with the intervention.~   "
7104|NCT03473860|"~     The purpose of this study is to investigate the change of total cholesterol content of~     erythrocyte membranes (CEM) in patients with coronary artery disease treated with secondary~     prevention drugs, and the correlation with the prognosis.~   "
4595|NCT03506763|"~     Will be perform a RCT to compare pain measure on office hysteroscopy after pre-medication~     with oral analgesic. Patients will be alocate to oral sodic diclofenac, scopolamin or~     placebo. We will compare visual analog score of pain after the procedure.~      Patients: patients with indication of office hysteroscopy to evaluate uterine intracavitary~     abnormality.~      Interventions Group 1 (control) The patients will receive about 2 h prior to the procedure 2~     placebo tablets.~      Group 2 (diclofenac + scopolamine) The patients will receive about 2 h prior to the procedure~     1 tablet of diclofenac sodium 50 mg and 1 tablet of scopolamine 2 mg.~      Group 3 (diclofenac only). Patients will receive approximately 2 h prior to the procedure 1~     tablet of diclofenac sodium 50 mg and 1 tablet of placebo.~   "
4596|NCT03506750|"~     Patients with proliferative diabetic retinopathy requiring surgical intervention will receive~     a pre-operative injection of Conbercept. Patients will be recruited into different groups~     according to variable time intervals (1 to 7 days) between intravitreous injection and~     surgery. At initial, pre-injection aqueous humor and blood sample will be collected in order~     to provide baseline VEGF-A, -B, placental growth factor (PIGF), and other cytokine levels. At~     the onset of the vitrectomy, a second aqueous humor, blood, and vitreous sample will be taken~     to obtain intra-operative levels of , VEGF-A, -B, PIGF, and other cytokine levels.~   "
4597|NCT03506737|"~     Objective: To evaluate the effects of an early-based cardiac rehabilitation program on the~     functional capacity, inspiratory muscular strength and clinical outcomes in hospitalized~     heart failure patients before and after heart transplantation. Method: 30 hospitalized heart~     failure patients awaiting cardiac transplantation will be selected and randomized in 2~     groups: conventional group (n = 15) - conventional exercise protocol: breathing exercises and~     global active exercises of upper and lower limbs in the sitting position; and Intervention~     group (n = 15) - cycle ergometer exercise protocol: each session consists of cycling on a~     stationary bicycle in the seated position for 20 minutes. In both groups, the exercise~     protocols will be applied twice a day until the hospital discharge, always supervised by a~     physiotherapist and a doctor. The evaluation procedures in all patients of the research will~     be: functional capacity measured by the 6 minute walk test and inspiratory muscle strength~     measured by manovacuometry. Evaluations will be repeated in 3 distinct moments: after 24h of~     hospital admission and/or clinical stabilization; before transplantation and after~     transplantation in hospital discharge.~   "
4598|NCT03506724|"~     In this study, the investigators will evaluate the blood pressure response to nifedipine and~     labetalol in pregnant and postpartum patients, who present with hypertensive disease in~     pregnancy with severe range blood pressure defined as greater than 160/110. These~     anti-hypertensives are first line therapy for management of severe range blood pressures in~     pregnancy and postpartum by the American Congress of Obstetricians and Gynecologist (ACOG).~     In addition at the Mount Sinai West site, the investigators will also analyze the ADRB1 and~     similar genes involved in beta blockade, genes involved in calcium channel blockade and other~     genes implicated in blood pressure response among pregnant and postpartum patients receiving~     labetalol and nifedipine. This analysis will be used to determine if a pharmacogenetic~     association exists between variant alleles in these receptors in the pregnant and postpartum~     population.~   "
4599|NCT03506711|"~     This project aims to assess coronary vessel response to isometric handgrip exercise (IHE)~     during magnetic resonance imaging (MRI) in children with T1D children and healthy controls.~     The investigators will compare the groups in terms of surrogate markers of intima media~     alteration and arterial stiffness, i.e. carotid intima media thickness (CIMT) and aortic~     pulse wave velocity (PWV).~   "
4600|NCT03506698|"~     The implementation research project aims to develop and evaluate models for scaling up KMC in~     health facilities across India and Ethiopia and thereby develop effective approaches to~     achieve high population coverage~   "
4601|NCT03506685|"~     The purpose of this study is to determine if dry needling (DN) and soft tissue mobilization~     (STM) is superior to standard treatment protocol for affecting pain, pain medication usage~     and measurements of range of motion (ROM) after ACL reconstruction surgery compared to a~     standard treatment protocol. Measurements of pain, pain medication usage, lower extremity~     functional scale (LEFS) and ROM will be taken day 2 post op and 1 week, 2 weeks, 3 weeks, and~     4 weeks post op. It is hypothesized that the inclusion of DN and STM will acutely decrease~     the demand for pain medication and improve objective measurements when compared to a standard~     treatment protocol. Findings will potentially lead to insights as to the benefit of applying~     these interventions to help decrease the demand for pain medication post-surgery.~   "
4602|NCT03506672|"~     Between 13 and 60% of older people who live with Alzheimer's disease (ADRD) in long-term care~     facilities (LTCFs) manifest vocal behaviours (VB) that may seem inappropriate, e.g. moaning,~     screaming, calling out. These behaviours may indicate ill-being, disturb others, create~     feelings of powerlessness in family and formal caregivers, and lead to inappropriate~     medication. Previous efforts to reduce VB have been largely ineffective. A new approach was~     developed based on finding the underlying reasons for VB through a partnership between family~     and formal caregivers. The goals are to reduce VB, enhance older people's well-being, and~     increase family and formal caregivers' empowerment. The approach was tested in a pilot study~     of 14 triads comprising an older person living with ADRD, a family caregiver and a formal~     caregiver. The results were promising; overall, it is feasible to implement the approach in~     LTCF and it has positive effects on older people, family and formal caregivers. Now the~     investigators propose to assess the clinical and economic impact of the approach in 20 LTCFs~     with 108 triads like those in the pilot study. The approach will be implemented in 10~     randomly selected experimental LTCFs; the other 10 (control group) will continue with their~     usual practices. The investigators will measure VB frequency and the well-being of the older~     people before, two and four months after starting the implementation. They will also measure~     the perceived disruptiveness of VB for family and formal caregivers, their ability to work in~     partnership and their empowerment relative to VB. The investigators will compare data between~     the control and experimental LTCFs, and calculate cost-effectiveness based on changes in VB~     frequency. The proposed three-year project aims to improve the well-being of all involved in~     LTCF by promoting a better understanding of VB and implementing a solution to optimize care.~     The investigators believe the findings will provide evidence to justify the wider~     implementation of the approach in LTCF.~   "
4603|NCT03506659|"~     Use of cutaneous electrochemical conductance for preclinical screening of small-caliber nerve~     fibers~   "
4616|NCT03506490|"~     Scientific evidence suggests that an aerobic exercise session promotes improvements in the~     consolidation of motor memory in adults. In this sense, the main purpose of this study was to~     investigate if an aerobic training session could improve motor memory consolidation in older~     people.~   "
4895|NCT03502837|"~     Disentangling the vegetative state from the minimally conscious state is often difficult when~     relying only on behavioral observation. In this study, the investigators explored a new~     event-related potential paradigm as an alternative method for the detection of voluntary~     brain activity and cognitive abilities in the patients with disorders of consciousness.~   "
4604|NCT03506646|"~     This is a double-blinded, randomized, crossover design study to assess the effects of dietary~     nitrate supplementation (beetroot juice) on peripheral artery disease (PAD) patients (ages~     50-85) diagnosed with Fontaine stage I or II PAD (as determined by vascular surgeon, Dr.~     Pipinos at UNMC). Exclusion criteria include: 1) experience severe claudication (leg pain) at~     rest or tissue loss due to PAD (Fontaine stage III and IV), 2) have limited walking capacity~     due to conditions other than PAD, 3) are already supplementing with a form of dietary~     nitrate, or 4) have an allergy to beetroot juice.~      Subjects will be required to visit the lab 3 times and will be randomized to receive either~     the supplement or the placebo for the 2nd and 3rd visits. There will be a washout period of~     14 days between the 2nd and 3rd visits. Visit 1 will take approximately 2 hours and the~     2nd/3rd visits will take approximately 1.5 hours. Total experimentation period will last~     approximately 15 days.~      Visit 1 will consist of non-invasive baseline testing including assessment of endothelial~     function (flow-mediated dilation by ultrasound imaging), maximal walking capacity (Gardner~     treadmill protocol), leg function (near-infrared spectroscopy, time to onset claudication,~     blood flow to lower extremities), and body core temperature (rectal thermometer). Visits 2~     and 3 will require consumption of either the supplement or placebo. The same tests from the~     baseline measurements will be performed for visits 2 and 3. There will be a recommended~     fourth visit, albeit not required, to review study results.~   "
4605|NCT03506633|"~     Title: Impacts of mitochondrial-targeted antioxidant on leg blood flow and skeletal muscle~     mitochondrial function in peripheral artery disease patients.~      Peripheral artery disease (PAD) is a common cardiovascular disease, in which narrowed~     arteries reduce blood flow to the limbs, causing pain, immobility and in some cases~     amputation or death. PAD patients have shown higher levels of systemic and skeletal muscle~     inflammation due to the impaired oxygen transfer capacity of these blood vessels. This~     attenuated oxygen transfer capacity causes hypoxic conditions in the skeletal muscle and~     results in mitochondrial dysfunction and elevated reactive oxygen species (ROS). These~     harmful byproducts of cell metabolism are the major cause of intermittent claudication,~     defined as pain in the legs that results in significant functional limitations. One potential~     defensive mechanism to these negative consequences may be having higher antioxidant capacity,~     which would improve blood vessel vasodilatory function, enabling more blood to transfer to~     the skeletal muscles. Therefore, the purpose of this project is to examine the impact of~     mitochondrial targeted antioxidant (MitoQ) intake on oxygen transfer capacity of blood~     vessels, skeletal muscle mitochondrial function, leg function, and claudication in patients~     with PAD. Blood vessel oxygen transfer capacity in the leg will be assessed in the femoral~     and popliteal arteries. Skeletal muscle mitochondrial function and ROS levels will be~     analyzed in human skeletal muscle via near infrared spectroscopy and through blood samples.~     Leg function will be assessed by walking on a force platform embedded treadmill and~     claudication times will be assessed with the Gardner maximal walking distance treadmill test.~   "
4606|NCT03506620|"~     The goal of this study is to determine whether QL blocks reduce opioid consumption following~     arthroscopic hip surgery by decreasing postoperative pain. Considering the current opioid~     epidemic, the responsibility of physicians to help prevent addiction, and the increasing~     prevalence of arthroscopic hip surgeries, this study holds a tremendous potential benefit for~     future patients.~   "
4607|NCT03506607|"~     The aim of this randomized controlled trial is to:~      Phase I: To explore, in a first pilot phase, the adequate combination of hypoxia severity and~     exercise intensity in patients with symptomatic lower extremity artery disease (LEAD). Acute~     walking performances and physiological responses (vascular and muscular) to a normobaric~     hypoxic exercise performed will be assessed at two different altitudes (1500 m and 2500 m).~   "
4608|NCT03506594|"~     The study is conducted in women at the menopause with a clinical diagnosis of Genitourinary~     Syndrome, which presents symptoms in of vulvovaginal atrophy and tract urinary and were~     treated with radiofrequency non ablative technique for capacitive transfer in intra-vaginal.~     All participants were evaluated by a physical therapist and did the exam of PH vaginal, cell~     maturation index and questionnaires. The participants made five sessions of Radio Frequency~     (RF) with an interval of seven days between them. The application of RF was performed by~     physical therapist trained in the technique of radio frequency through the Capenergie brand~     device with capacitive transfer method using non-ablative handle with active electrode~     intra-vaginal and coupling electrode placed on the participant's back. For application, the~     participants were in gynecological position. The session had an average duration above 20~     minutes. The temperature was measured by an infrared thermometer when it reached 41graus~     radiofrequency was maintained for 2 minutes in the anterior wall and 2 minutes more in the~     posterior wall of vagina.~   "
4609|NCT03506581|"~     This is a large and comprehensively phenotyped cohort with fasting glycaemia where the~     predictive value of body composition and anthropometric measures of total and central fat~     distribution for postprandial carbohydrate intolerance are studied.~   "
4610|NCT03506568|"~     Glaucoma is the second leading cause of visual impairment worldwide. Eye drop medications~     reduce vision loss from glaucoma by at least 60%, but eye drops must be taken every day to be~     effective. However, adherence to eye drop treatment is poor with only 50% of patients~     regularly taking their prescribed eye drops. We are developing the Devers Drop Device (D3)~     eye drop monitor to accurately measure eye drop cap removal and to improve eye drop-taking~     behavior. We will test eye drop adherence with the D3 device in a randomized, prospective~     clinical trial.~   "
4611|NCT03506555|"~     A randomised controlled trial (RCT) comparing the closed (Veress needle) with the open~     (Hasson) laparoscopic entry technique in haemodynamically stable patients undergoing either~     emergency or elective surgical procedures was conducted over a 13-month period. The success~     rate and complications related to the technique were recorded and analysed.~   "
4612|NCT03506542|"~     1. Study objective: To assess the efficacy and safety of collagen matrix implant (Ologen®;~          OLO) in phacotrabeculectomy and to compare with mitomycin C (MMC) augmented~          phacotrabeculectomy.~        2. Study Design: The study is designed as a prospective randomized trial. Patient who meet~          the inclusion/exclusion criteria and sign the informed consent form will be included for~          this study.~        3. Follow-Up: This investigation is including 7 post-operative visits and follow-up within~          12 months from the date of surgery. Patients should be seen at postoperative days 1, 7,~          30, 90, 180, 270 and 360.~   "
4614|NCT03506516|"~     Does mixing alcohol make hangover worse?~   "
4617|NCT03506477|"~     This will be a single-center, randomized, double-blinded, vehicle-controlled clinical study~     to determine the efficacy of Enstilar® foam, a combination of calcipotriene and betamethasone~     dipropionate 0.005%/0.064%, in the treatment of psoriasis vulgaris in skin of color (FST~     IV-VI). This study will also evaluate the degree of erythema versus hyperpigmentation in~     psoriasis plaques in skin of color (and its change with Enstilar ® treatment) as well as the~     effect of Enstilar ® on post-inflammatory hyperpigmentation and quality of life.~   "
4618|NCT03506464|"~     Background: Plantar fasciitis is the most common cause of heel pain in runners. No studies~     have described the short-term effects of myofascial release on plantar fasciitis using~     ultrasound.~      Objectives: To describe the immediate sonoelastographic changes in the plantar fascia of~     amateur runners with fasciitis after applying a myofascial release technique.~      Design: A single-centre, experimental and controlled study.~      Method: Patients with plantar fasciitis and a group of healthy subjects will be examined~     using B-mode and real time sonoelastography scanning. Fascia thickness, echointensity and~     echovariation of the color histogram will be analyzed pre- and post intervention. A two-way~     (Group × Time) repeated measures ANOVA will be performed.~   "
4619|NCT03506451|"~     The purpose of this single institution, pilot study is to explore the out of pocket~     (OOP)costs and financial toxicity of cancer care for patients during definitive treatment of~     head and neck cancer with radiation therapy with or without chemotherapy and surgical~     resection. The study team will assess how the financial burden of cancer care impacts quality~     of life as well as treatment-related decision-making from a patient perspective.~   "
4620|NCT03506438|"~     The quality of palliative care is highly variable for many patients treated in intensive care~     units (ICUs) and their family members. To address these challenges, the investigators will~     test the impact of a mobile app designed to help families navigate ICU-based palliative care~     vs. usual care. The investigators hypothesize that the intervention will reduce~     patient/family member unmet palliative care needs and improve the quality of clinical-family~     communication in racially/ethnically diverse populations.~   "
4621|NCT03506425|"~     The causes of ALS are largely unknown. However, mitochondrial dysfunction, resulting in~     impaired energy production, oxidative stress and apoptosis, may play a key role in ALS~     progression. Triheptanoin can improve mitochondrial function and energy production and~     therefore has potential for slowing ALS progression. Indeed, triheptanoin slowed motor neuron~     loss and delayed the onset of weakness in a mutant SOD1 model of ALS. This pilot trial will~     determine if Triheptanoin is safe tolerable, alters biomarkers of brain energy metabolism and~     oxidative stress, and slows functional decline in people with ALS.~   "
4622|NCT03506412|"~     To determine biomarker responses to Entresto™in patients with Heart Failure with preserved~     Ejection Fraction (HFpEF) and who have high or low serum neprilysin (NEP) levels.~   "
4623|NCT03506399|"~     The study will evaluate the effect of oral contraceptive (birth control pill) on the blood~     level of lanabecestat when both are given together. Side effects will be monitored and~     documented. This study will last up to 27 days for each participant, not including screening.~     Screening is required within 42 days prior to first dose.~   "
4624|NCT03506386|"~     The purpose of this study is to present a descriptive analysis of demographic and clinical~     characteristics of the participants, as well as of the treatment patterns for MM in Brazil.~   "
4625|NCT03506373|"~     This phase II trial studies the side effects of ibrutinib citrate when given with ixazomib,~     and determines how well they work in treating participants with Waldenstrom macroglobulinemia~     that has come back or does not respond to treatment. Enzyme inhibitors, such as ibrutinib and~     ixazomib citrate, may stop the growth of cancer cells by blocking some of the enzymes needed~     for cell growth.~   "
4626|NCT03506360|"~     This phase II trial studies how well pembrolizumab works when given together with ixazomib~     citrate and dexamethasone in treating participants with multiple myeloma that has come back.~     Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells~     to grow and spread. Ixazomib citrate may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, work~     in different ways to stop the growth of cancer cells, either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab~     together with ixazomib citrate and dexamethasone may work better in treating participants~     with multiple myeloma.~   "
4627|NCT03506347|"~     The purpose of this study is to determine whether or not giving a lower dose of antibiotics~     (Vancomycin) in the area where it is needed (the knee joint) is more effective at obtaining~     adequate tissue levels of the antibiotic than the current standard dose which is given~     intravenously (IV) through a wrist vein. The use of IORA vancomycin requires the use of a~     tourniquet for the duration of the procedure. Many surgeons prefer to perform the surgery~     with tourniquet use minimised or without a tourniquet at all. The aim of this study is to~     evaluate whether IORA vancomycin can achieve effective tissue concentrations with tourniquet~     use minimised.~   "
4628|NCT03506334|"~     The Researchers want to assess the short-term safety of Anterior Vertebral Body Tethering~     (AVBT) in skeletally immature subjects with moderate to severe scoliosis.~   "
4629|NCT03506321|"~     To compare the incremental benefit of chromoendoscopy in addition to high definition white~     light and narrow band imaging in predicting submucosal invasion within laterally spreading~     lesions in the colon and in determining the presence of residual or recurrent adenoma at the~     post endoscopic resection scar~   "
4630|NCT03506308|"~     This prospective, global, multicenter, single arm post-approval study is designed to~     investigate the clinical use and safety of the Lutonix® 035 AV Drug Coated Balloon PTA~     Catheter in subjects presenting with clinical and hemodynamic abnormalities in native~     arteriovenous (AV) fistulae located in the upper extremity.~   "
4644|NCT03506126|"~     This study aims to determine the requirement for leucine, an essential amino acid, in adults~     over the age of 65 years. It is known that protein and amino acid metabolism may be altered~     with age and leucine, in particular, may be important in the diet of older adults.~      Eight different levels of leucine intake will be tested in each subject in random order. Each~     level of leucine intake will involve a 3-day maintenance diet, with measures being collected~     on the third.~   "
20075|NCT03304197|"~     This study will evaluate the effects manipulating ingested fluids can have on hydration~     status and cycling performance. There will be 4 different conditions.~   "
4631|NCT03506295|"~     Transbronchial cryobiopsy carries a higher chance of establishing pathological diagnosis in~     diffuse parenchymal lung disease (DPLD) than traditional transbronchial forceps guided~     biopsy. It is a novel technique capable of obtaining large, high-quality samples of lung~     tissue in a minimally invasive manner. This procedure may decrease the need for surgical lung~     biopsy in 75% of cases. However, there is an increased risk of pneumothorax and airway~     bleeding compared to traditional transbronchial forceps guided biopsy.~      Several strategies are used by practitioners of this technique to mitigate the risks of~     significant bleeding and pneumothorax. These include prophylactic placement of an~     endobronchial blocker, the use of fluoroscopy guidance, instillation of cold saline to~     promote vasoconstriction, and establishment of a secure airway with endotracheal tube~     placement or rigid bronchoscopy~      . Vanderbilt University Medical Center is one of the most active centers in terms of~     cryobiopsies performed as part of the diagnostic workup of DPLD. Currently all transbronchial~     cryobiopsies here are performed under fluoroscopic guidance, with endotracheal tube~     intubation and endobronchial blocker placement. Despite these precautions, post biopsy~     bleeding complications occur and can substantially lengthen the duration of the procedure and~     occasionally expose patients to procedural complications.~      Radial ultrasound has been well utilized to define anatomy of peripheral lung and~     localization of peripheral pulmonary nodules. We postulate that using radial ultrasound to~     identify peribronchial lung parenchyma with low vascularity will mitigate the risk of~     hemorrhage during peripheral lung cryobiopsy in patients with DPLD and hence improve patient~     safety.~   "
4632|NCT03506282|"~     The purpose of this study is to determine whether in healthy subjects listening to music~     while running influences the ground pressure forces, the vertical loading and, overall, the~     running biomechanics.~   "
4633|NCT03506269|"~     This study is conducted to find out perception and knowledge about Menopause among Pakistani~     Woman.~   "
4634|NCT03506256|"~     To determine the efficacy and safety of Norfloxacin (Noroxin)~   "
4635|NCT03506243|"~     This study is for evaluating safety and efficacy of Recombinant human follicle-stimulating~     hormone (Follitrope) injection compared with Gonal-F® Pen undergoing controlled ovarian hyper~     stimulation in vitro fertilization - embryo transfer (IVF-ET) in China~   "
4636|NCT03506230|"~     Patients with uncontrolled diabetes [glycated hemoglobin (Hba1c)>8.5%] from low socioeconomic~     status neighborhoods in Jerusalem will be recruited. They will be randomly assigned to an~     intervention group and a control group. The intervention group will be offered a bonus to buy~     their medications, 100 Israeli Shekels (ILS) (30$) each month for 3 months, if they reduce~     their HBA1c by 0.7% or if their HbA1c level reaches 7.5%. After 6 months they will be~     eligible for another bonus for one month if they improve their HbA1c by 0.3% from the~     previous test. The control group will buy medications as usual. All participants will be~     contacted by phone and will be encouraged to contact their doctor, to perform blood tests and~     to maintain a healthy lifestyle.~   "
4637|NCT03506217|"~     Minimally invasive transapical off-pump chordae implantation includes features such as~     tachycardia, arrhythmia, hemorrhage, sudden hemodynamic changes caused by the device moving~     in the left ventricle and the atrium, for anesthetists. In this observational study, the~     investigators presented the investigators's hemodynamic recuperation and anesthesia~     experiences revealed by cardiac output measurement after transapical mitral valve repair.~   "
4638|NCT03506204|"~     It is a prospective cohort study.The primiparas in six geographic regions of China are~     recruited to observe the natural recovery of pelvic floor muscle. The pelvic floor muscle~     function is evaluated at 6 weeks,3 months and 12 months after delivery.~   "
4639|NCT03506191|"~     Pneumonia is a major cause of ICU admission, or may complicate ICU course. Among the~     causative pathogens, Stenotrophomonas Maltophilia is a rare pathogen, but affects usually~     patients with chronic pulmonary co-morbidities, or with long duration of mechanical~     ventilation and multiples treatment with broad spectrum antimicrobial therapy. However, there~     are only a paucity of data regarding epidemiology, impact and outcome of Pneumonia due to~     Stenotrophomonas Maltophilia in critically ill patients.~      Primary objective was to study factors associated with mortality in case of Pneumonia due to~     Stenotrophomonas Maltophilia. Secondary objectives were to describe factors associated with~     morbidity of Pneumonia due to Stenotrophomonas Maltophilia (duration of mechanical~     ventilation, ICU length of stay), and to report the characteristics of critically ill~     patients presenting Pneumonia due to Stenotrophomonas Maltophilia.~   "
4640|NCT03506178|"~     Obstructive sleep apnea (OSA) is an increasingly prevalent disorder characterized by repeated~     upper airway collapse during sleep, resulting in oxygen desaturation and frequent arousals.~     The etiology of OSA remains unclear.~      Many studies indicates an association between nasal obstruction and apnea. However,the~     precise nature of this relationship is far from clear and the importance of resistance to~     nasal airflow in the pathogenesis of airway collapse in OSA patients remains contentious.~      In this study, investigators perform 4 different ways to change subjective or objective~     patency of nasal cavity and observe the effects of the nasal airflow on nocturnal breathing,~     sleep,and upper airway muscles in OSA patients.~   "
4641|NCT03506165|"~     Rheumatoid arthritis (RA) is one of the most common autoimmune inflammatory arthritis~     affecting 0.5 to 1% population worldwide characterized by synovitis, increased inflammatory~     markers and progressive bone and cartilage erosion. RA is associated with an increased~     cardiovascular morbidity and mortality compared with the general population.~   "
4642|NCT03506152|"~     Procalcitonin is a promising marker of sepsis in critically ill patients. Procalcitonin have~     better diagnostic accuracy compared to White blood cell count and C - reactive protein.~     Investigators propose that adding Procalcitonin to the list of standard laboratory work up of~     critically ill patients with suspected sepsis could increase diagnostic accuracy leading to~     better patient care.~   "
4643|NCT03506139|"~     This clinical trial increases radiation to areas of the brain considered to be at risk for~     cancer. The at-risk areas are identified by a biological MRI scan. The study will look at~     side effects of the radiation and overall survival.~   "
4896|NCT03502824|"~     This is a prospective, multi-center, randomized, controlled clinical study Of PuraPly® AM and~     standard of care (SOC) compared to SOC alone for the management of Stage II-IV pressure~     ulcers located in the gluteal, ischial, hip, sacral, coccygeal, and trochanteric, malleolus,~     or heel area.~   "
4645|NCT03506113|"~     Background: Optimising the use of antibiotic agents is a pressing challenge to overcoming the~     rapid emergence and spread of multidrug-resistant pathogens in intensive care units (ICUs).~     Although Gram staining may possibly provide immediate information for predicting pathogenic~     bacteria, Gram stain-guided initial antibiotic treatment is not well established in the ICU~     setting. The investigators planned the GRam stain-guided Antibiotics ChoicE for~     Ventilator-Associated Pneumonia (GRACE-VAP) trial to investigate whether Gram staining can~     safely restrict the use of broad-spectrum antibiotics in patients with ventilator-associated~     pneumonia (VAP), which is one of the most common hospital-acquired infections in ICUs.~      Methods/Design: The GRACE-VAP trial is a multicenter, randomised, open-label parallel-group~     trial to assess the non-inferiority of Gram stain-guided initial antibiotic treatment to~     guidelines-based initial antibiotic treatment for the primary endpoint of clinical cure rate~     in patients with VAP. Secondary endpoints include the coverage rates of initial antibiotic~     therapies, the selected rates of anti-pseudomonal agents and anti-methicillin-resistant~     Staphylococcus aureus (MRSA) agents as initial antibiotic therapies, 28-day all-cause~     mortality, ICU-free days, ventilator-free days, and adverse events. Participants are randomly~     assigned to receive Gram stain-guided treatment or guidelines-based treatment at a ratio of~     1:1. In the Gram stain group, results of Gram staining of endotracheal aspirate are used to~     guide the selection of antibiotics. In the guidelines group, the combination of an~     anti-pseudomonal agent and anti-MRSA agent are administered. A total sample size of 200 was~     estimated to provide a power of 80% with a 1-sided alpha level of 2.5% and a non-inferiority~     margin of 20%, considering 10% non-evaluable participants.~      Discussion: The GRACE-VAP trial is expected reveal whether Gram staining can reduce the use~     of broad-spectrum antibiotics without impairing patient outcomes and thereby provide evidence~     for an antibiotics selection strategy in patients with VAP.~   "
4646|NCT03506100|"~     The objective of this study was verify if there are differences in spirometry values in~     children aged between 6 and 12 years who practice swimming complemented with water walking at~     the end of each session and those who only practice swimming.~   "
4647|NCT03506087|"~     This project will develop and test a model intervention for Advance Care Planning (ACP) for~     patients with advanced chronic kidney disease (CKD) cared for in nephrology clinics that have~     the capacity to consult with or refer to palliative care. Specifically, we will compare the~     effectiveness of having a trained ACP coach meet in person with patients to discuss their~     goals and preferences vs. providing patients with a packet of material to review on their own~     and then discuss with their nephrologist at their initiation.~      Hypothesis: In patients aged 55 or older with stage 3-5 Chronic Kidney Disease cared for in a~     CKD outpatient clinic, an advance care planning process that involves in-person meetings with~     a trained ACP coach will be more effective than providing patients with printed educational~     materials alone.~   "
4648|NCT03506074|"~     Dietary choices are influenced by several factors, including physiological, social or genetic~     factors. Among these, flavor is the most important determinant modulating the preferences~     versus specific foods.~      Flavor perception is the result from the sensory integration of taste and odor properties of~     food.~      Aim of the present study was to assess flavor abilities in a large population using a~     validated perceptive test.~   "
4649|NCT03506061|"~     Orkambi is currently approved for patients with CF carrying two copies of the common F508del~     variant, but not for those with the P67L mutation. This is a clinical study of 22 subjects~     carrying P67L, each given Orkambi for approximately four weeks. The researchers will monitor~     clinical endpoints that include FEV1, sweat chloride, and nasal potential difference.~     Cutaneous punch biopsy material will be obtained from each subject so that iPS cells can be~     differentiated into airway epithelial monolayers and tested for response to Orkambi.~   "
4650|NCT03506048|"~     This phase II trial studies how well lenvatinib works when given together with standard of~     care iodine I-131 in treating patients with radioactive iodine-sensitive differentiated~     thyroid cancer. Lenvatinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~   "
4651|NCT03506035|"~     Rheumatoid arthritis (RA) is an autoimmune and sistemic disease,characterized by joint~     sinovitis and the production of autoantibodies (Ab). The Ab against citrullinated peptides~     (ACPA) are the most specific (92-98%), and high sensitivity (75-81%) and they are of~     prognostic value. ACPA are already in the beginning of the disease in most cases, having been~     found years before its onset. Recent studies have suggested that ACPA may have a role in~     perpetuating inflammation, in the generation of bone erosions and in pain in RA.~      Citrullination is a post-translational modification mediated by the PAD, which transforms an~     arginine into a citrulline. In vivo, this enzyme acts in proinflammatory environments.~     Despite being widely studied, none of the natural citrullinated substrates have been shown to~     be the triggering and/or perpetuating factor in the response of B cells in RA, understanding~     this response as the production of ACPA. In fact, the most specific and sensitive commercial~     test for the detection of ACPA uses synthetic peptides protected by a patent.~      In the other hand, the genetic factor that most increases susceptibility to develop RA is a~     shared sequence of aminoacids (QKRAA, QRRAA i RRRAA), in the HLA-DRB1 gene, known as the~     shared epitope (SE). Also, SE, confers prognostic value, and is associated with the presence~     of ACPA. These SE sequences contain arginines (R), which are susceptible to be citrullinated~     by the PAD enzyme.~      We propose the hypothesis that citrullinated SE act as an antigen capable of activating the~     inflammatory response mediated by B and T cells in RA. The recognition of an HLA as a foreign~     one, would originate an answer of alloimmune type, not valued to date.~      The objective of the study is to test the immune response mediated by B cells and T cells, in~     cases and control samples, through an in vitro model that confronts them with peptides~     containing the citrullinated-SE sequence. In addition, we will evaluate the association~     between these results with the clinical features of cases (RA included in the study). Their~     role as a biomarker, as well as their potential to improve the tests currently available to~     detect ACPA will be explored.~   "
4652|NCT03506022|"~     Obstructive sleep apnea (OSA) and Type 2 diabetes are two frequent diseases that occur in~     adult population. The prevalence of OSA is higher in people with Type 2 diabetes compared~     with the general population7 ; in addition, the OSA syndrome is almost assessed in obese type~     2 diabetes. The relationship between OSA and Type 2 diabetes has been well characterized: the~     OSA can contribute to increased insulin resistance or glucose intolerance; and, diabetes may~     worsen sleep-disordered breathing because of autonomic neuropathy8,9. The main link between~     OSA and Type 2 diabetes is central obesity, which triggers glucose intolerance/insulin~     resistance and is also an independent risk factor for OSA. Type 1 diabetes is generally not~     related to obesity; however, sleep-disordered breathing in these patients was described in~     few reports early as 1985 by pioneers such as Guilleminault5 and the prevalence of OSA is~     estimated at range 10 to 40% in type 1 diabetes patients. Few studies had evaluated the~     prevalence of sleep disorders in particular the sleep apnea syndrome in patients with type 1~     diabetes and even less their influence on the glycemic control.~      This study will take place at the CHU of Amiens-Picardie during a one-night hospitalization.~     The investigators will study in 44 type 1 diabetes mellitus (IAH apnea hypopnea index ≥15)~     who underwent polysomnography and continuous glucose monitoring of blood glucose~   "
4697|NCT03505424|"~     The objective of this study is to determine the extent to which the SMART NICU2HOMEapp, a~     mobile application designed for parents of premature infants to receive daily, real-time~     information about their infants and personalized education material based on parents'~     anticipated concerns and their infant's clinical status, is effective in:1) improving~     parents' competency in caring for their sick infants, 2) reducing stress, 3) supporting~     parents' social supports and 3) improving NICU outcomes (parent satisfaction, length of stay,~     readmission rates.)~   "
4653|NCT03506009|"~     Acute ischemic stroke (AIS) is the most common type of stroke, which has high rate of~     morbidity, mortality and disability. A large number of studies have confirmed that the~     thrombolytic therapy can effectively open blood vessels and improve the functional prognosis~     of acute ischemic stroke. Therefore, all guidelines recommend giving thrombolysis treatment~     to acute ischemic stroke patients within 4.5 hours of onset. However, about 1/3 patients~     receiving thrombolysis will have good prognosis, while a large number of patients will still~     be disabled and even dead. How to improve the neurofunction prognosis of thrombolytic~     patients has been a hot topic in the world.~      Recent studies have found that the combined application of argatroban and rt-PA in the~     treatment of acute anterior circulation infarction might improve the clinical prognosis and~     not significantly increase bleeding. Some studies have reported that the combined application~     of argatroban and rt-PA could improve the blood vessel opening rate, and prevent re-occlusion~     after opening.~      Based on the discussion, the present study is designed to explore the efficacy and safety of~     argatroban plus rt-PA in the treatment of acute posterior circulation infarction.~   "
4654|NCT03505996|"~     This is a multicenter, single-arm phase II study to evaluate the efficacy and safety of~     CS1001 monotherapy for relapsed/refractory classical Hodgkin Lymphoma (rr-cHL)~   "
4655|NCT03505983|"~     The purpose of this study is to develop criteria for prosthetic foot prescription for~     Veterans and Service Members with transtibial limb loss. The objectives are to: 1) Determine~     the appropriate functional outcome tests and measures to support the prescription of a type~     of Energy Storing and Returning (ESR) non-articulating, articulating or active plantarflexion~     prosthetic ankle-foot for a Veteran or Service Member with transtibial limb loss. 2)~     Correlate patient goals and subjective measures with objective data to determine the~     appropriate prosthetic ankle-foot category that will facilitate the greatest overall function~     to the user. 3) Develop criteria for the appropriate prescription of non-articulating ESR,~     articulating ESR, and active plantar flexion ESR ankle-foot units.~   "
4656|NCT03505970|"~     The aim of this study is to evaluate the changes in activity of transporters of H+~     (monocarboxylate transporters; MCT1, MCT4, NHE) following sodium bicarbonate supplementation~     and subsequent exercise performance. Fifteen healthy men (age 18-35 years) will be invited to~     attend the laboratory on five separate visits to a randomized, double-blind,~     placebo-controlled study. Participants will be supplemented with a 0.3 g/kg dose of sodium~     bicarbonate or placebo (Analytical Pharmacy, Brazil) in opaque gelatin capsules. One hour~     after supplementation they will perform a 1-km time trial and every 10 minutes a blood sample~     will be collected. A muscle biopsy will be taken prior to supplementation, immediately prior~     to exercise, and immediately post-exercise. A questionnaire will be also used to evaluate the~     side-effects associated with sodium bicarbonate supplementation. Muscle and blood samples~     will be analysed for acidity and H+ and muscle samples will be analysed for H+ transporters~     (MCT1, MCT4, NHE).~   "
4657|NCT03505957|"~     SafeBreak Vascular is a medical device indicated for fluid flow control during the~     administration of IV fluids/medication to the patient's vascular system and to aid in the~     prevention of unintended disruption and dislodgment of IVs. SafeBreak Vascular may be used~     for any hospitalized patient with gravity tubing or IV pumps, for intermittent infusion or~     continuous infusion.The primary objective of this study is to determine if the delivery of IV~     medications and/or fluids with SafeBreak Vascular functions with the same reliability as~     current standard IV tubing.~   "
4658|NCT03505944|"~     Phase I/II trial, with the aim of evaluating the efficacy of venetoclax to the backbone of~     rituximab-lenalidomide in patients with relapsed/refractory MCL.~   "
4659|NCT03505931|"~     -  Prospective, multi-center single-arm observational study~        -  A total of 100 subjects with femoropopliteal artery disease who meet all inclusion and~          exclusion criteria will be included.~        -  Patients will be followed clinically for 12 months after the procedure.~        -  An imaging study (duplex ultrasound, CT or catheter-based angiography) follow-up~          according to participating hospital's protocol will be performed at 12 months.~        -  Ankle-brachial index, symptom status and presence of stent fracture will be evaluated at~          12 months.~   "
4660|NCT03505918|"~     This is a randomized controlled trial evaluation effect of postoperative rehabilitation after~     surgery for lumbar disc herniation.~      The primary aim of this study is to evaluate the effect of unsupervised home exercises~     compared to supervised physical rehabilitation.~      Secondary aims of this study are to determine if there is a difference in cost-effectiveness~     in patients undergoing supervised physical rehabilitation in patients after surgery for~     lumbar disc herniation compared to unsupervised home exercises.~   "
4661|NCT03505905|"~     HYPOTHESIS:~      Pregnenolone administration will be associated with greater reduction in depressive symptom~     severity than placebo in women with current mMDD.~      STUDY AIMS:~      Primary Aim: Determine if pregnenolone is associated with greater reduction in depressive~     symptom severity than placebo in women with mMDD, as measured by MADRS.~      Secondary Aims:~        1. Determine if pregnenolone is associated with greater reduction in anxiety symptom~          severity than placebo in women with mMDD.~        2. Determine if pregnenolone is associated with greater improvement in cognition than~          placebo in women with mMDD.~        3. Determine if pregnenolone is associated with greater improvement in quality of life than~          placebo in women with mMDD.~        4. Determine if pregnenolone is associated with greater improvement in vasomotor symptoms~          of menopause than placebo.~      Mechanistic Aims:~        1. Determine whether changes in neurosteroid levels with pregnenolone mediate clinical~          response.~        2. Determine if baseline neurosteroid levels predict pregnenolone response.~        3. Determine whether depressive symptoms, anxiety, sleep or vasomotor symptoms improve~          first. A crossed-lagged panel model will explore serial correlations between changes in~          outcome measures.~   "
4662|NCT03505892|"~     The objectives of this prospective observational study is to explore 1-year clinical response~     via both Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing~     Spondylitis Disease Activity Score (ASDAS) after initiation of adalimumab therapy in AS~     patients from routine clinical practices in Taiwan.~   "
4698|NCT03505411|"~     The research aims to determine the impact of 30-day supplementation of melatonin on the~     antioxidative defense mechanisms and the release of markers of oxidative stress and~     inflammation in rowers and footballers undergoing training of submaximal intensity.~   "
4663|NCT03505879|"~     Next Generation Sequencing is able to sequence all DNA detected in a sample, including short~     strands. This differs from PCR testing, which uses pre-determined DNA primers to detect a~     limited number of specific, often large, strands of DNA. The investigators will test the~     ability of NGS to detect Borrelia burgdorferi DNA in the blood of study participants with an~     erythema migrans rash. This study will compare 20 study participants with the EM rash (cases)~     to 10 healthy study participants without an EM rash (controls). The investigators will~     collect clinically relevant information and send both currently used Lyme testing and Next~     Generation Sequencing in both the cases and controls. The case participants will then have~     two requested (but not required) follow up appointments at 1-3 weeks and 2-3 months later to~     obtain updated clinical information and send repeat NGS testing. The investigators will then~     conduct basic descriptive statistics on the results to determine if NGS is capable of~     detecting Lyme DNA during the acute phase of infection.~   "
4664|NCT03505866|"~     An intervention study was designed to examine the impact of impact of community home-based~     care intervention on mental health and treatment outcome in HIV-positive people. The~     intervention comprised a home-based counseling on anti-retroviral therapy (ART) adherence,~     psycho social support, basic health care services at the home of HIV-positive people. The~     intervention started in March, 2018 and completed in August 2018. The major measurements of~     the interventions were ART adherence, status of depression, anxiety, and stress levels.~   "
4665|NCT03505853|"~     The purpose of this study is to evaluate the effect of givosiran on the pharmacokinetics of~     the 5-probe cocktail of midazolam, caffeine, losartan, omeprazole, and dextromethorphan, and~     their metabolites, in asymptomatic patients with Acute Intermittent Porphyria.~   "
4666|NCT03505840|"~     Antiphospholipid antibodies are autoantibodies directed against phospholipid‐binding~     proteins. Among these groups of antibodies, lupus anticoagulant (LA) and anticardiolipin~     antibodies (aCL)~   "
4667|NCT03505827|"~     Glaucoma is a leading cause of blindness worldwide. Damage to the optic nerve results in~     vision loss gradually. This vision loss can be detected by using visual field testing, and is~     a way of monitoring glaucoma progression. As this population ages, cataracts develop, and~     patients need to undergo cataract surgery to replace the cloudy crystalline lens with an~     artificial intraocular lens (IOL). The standard of treatment is implantation of a monofocal~     IOL, but this limits depth of focus and does not allow clear vision at both distance and near~     without glasses post-operatively. Multifocal and trifocal lenses split light into multiple~     distinct foci at near, intermediate and far distances without glasses correction. However,~     these lenses have been shown to reduce contrast sensitivity and impair visual field testing~     results, and are not recommended in patients with glaucoma. The TECNIS Symfony IOL has~     recently been approved by Health Canada and offers an extended range of vision with a single~     elongated focal point to allow patients to see at both distance and near. The lens is~     advertised to enhance contrast sensitivity, but it is currently unknown whether the TECNIS~     Symfony IOL impacts visual field testing. We will study the visual field changes in patients~     undergoing both TECNIS ZCB00 monofocal and TECNIS Symfony extended depth of focus IOL~     implantation during cataract surgery. The results of this study will impact the advice~     cataract surgeons give to patients with glaucoma, regarding whether this population of~     patients would benefit from a standard monofocal IOL implantation or an extended depth of~     focus TECNIS Symfony IOL implantation.~   "
4668|NCT03505814|"~     monocentric randomized controlled trial starting from Mars 2017, recruitment is still~     ongoing. Patients aged between 0-45 days needing mechanical ventilation (MV) with tracheal~     intubation were included random assignation in two groups for post-extubation management:~     Group Optiflow (GO) for patients receiving High Flow Nasal Cannula Oxygen Therapy HNFC and~     Control Group (CG) for conventional treatment.~      Patients were evaluated during the first 72h following extubation. Primary endpoint was the~     incidence of reintubation. Secondary endpoints were incidence of post-extubation respiratory~     failure, time to reintubate and weaning time from oxygen. Respiratory and hemodynamic~     parameters were assessed and compared between the two groups upon extubation, after 2 hours~     (H2), at H6, H12, H24, H36, H48 and H72. Length of stay (LOS) and mortality were also~     estimated.~   "
4669|NCT03505801|"~     The purpose of the Confirm Rx SMART Registry is to collect real world data to assess the~     safety and performance of the Confirm Rx Insertable Cardiac Monitor (ICM) and system over a~     12 month period. A sub-set of subjects enrolled in the Confirm Rx SMART Registry will meet~     the Post Market Clinical Follow-Up (PMCF) requirement for CE mark.~   "
4670|NCT03505788|"~     This clinical research study is being conducted in multiple hospitals in Belgium and~     approximately 519 patients with acute decompensated heart failure are expected to~     participate. Large-scale research shows that 90% of the physicians treat volume overload with~     high doses of loop diuretics. However, there is not a lot of scientific data available~     regarding the optimal doses of these diuretic medications. In addition, it is observed that a~     lot of people, treated with these drugs, are being readmitted to the hospital due to a new~     episode of heart failure. The hypothesis of this study is that the volume overload could be~     better treated when patients receive a combination of different types of diuretics.~     Additionally, the total dose of the administrated diuretics might be lower this way.~   "
4671|NCT03505775|"~     This study investigates the sodium content in the calf muscle and the skin obtained via~     23Na-magnetic resonance imaging in patients with chronic adrenal insufficiency compared to~     healthy controls.~   "
4672|NCT03505762|"~     This phase II trial studies how well tailored prednisone reduction works in preventing~     hyperglycemia in participants with B-cell non-Hodgkin lymphoma receiving combination~     chemotherapy treatment. Drugs used in chemotherapy, such as rituximab, cyclophosphamide,~     doxorubicin hydrochloride, vincristine sulfate and prednisone, work in different ways to stop~     the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Reductions in prednisone dose may lower blood sugar levels.~   "
4699|NCT03505398|"~     The objective of this pilot work is to determine the role of central and peripheral visions~     in explicit attention processes (saccade planning) in the case of visual impairment.~   "
4897|NCT03502811|"~     The MitraClip EXPAND Study (A Contemporary, Prospective Study Evaluating Real-world~     Experience of Performance and Safety for the Next Generation of MitraClip Devices) is~     designed to confirm the safety and performance of the MitraClip NTR System and MitraClip XTR~     System.~   "
4673|NCT03505749|"~     More than 90% of women in substance use treatment report history of physical and/or sexual~     trauma, and up to 60% meet criteria for both substance use disorder (SUD) and Post Traumatic~     Stress Disorder (PTSD). PTSD typically precedes onset of SUD, with substances used as a means~     to cope with physiological, psychological, and emotional symptoms resulting from the trauma.~     Women with PTSD experience greater severity of addiction symptoms, readmit into treatment~     more frequently than women without PTSD, and tend to have poorer treatment outcomes. Due to~     increased risk for exacerbation of PTSD on SUD severity and treatment success, and the~     specific vulnerabilities and needs of women with this comorbidity, SUD treatments that target~     both substance use and trauma recovery are needed. However, few interventions target both SUD~     and PTSD concurrently, and fewer still are specific to women.~      Mindfulness-Based Relapse Prevention (MBRP) has been shown to decrease craving, relapse~     rates, and quantity/frequency of use across several substances, and has shown acceptability~     in diverse populations. MBRP integrates mindfulness practices with cognitive behavioral and~     exposure-based approaches to increase self-regulatory skills while experiencing triggers~     previously associated with substance use, including challenging affective states such as~     those common to experienced trauma. Adapting MBRP to incorporate trauma education and~     treatment approaches has the potential to effectively treat women with the dual~     vulnerabilities of trauma history and SUD.~      The current study is thus designed to determine feasibility, acceptability, and initial~     efficacy of an adapted Trauma-Informed Mindfulness-Based Relapse Prevention (TI-MBRP)~     intervention for women in substance use treatment settings who have PTSD. TI-MBRP integrates~     trauma education and treatment approaches drawn from Cognitive Processing Therapy (CPT) into~     the standard MBRP protocol to provide a trauma-informed approach to treating women in~     substance use treatment settings. The current proposal will evaluate TI-MBRP, using a~     randomized, pre-post design, with 100 women in residential substance abuse treatment.~     Participants will be randomly assigned to participate in an 8-week TI-MBRP intervention or to~     continue with treatment as usual (TAU). Assessments will be collected pretest, posttest, and~     at one-month follow-up. Data from this study will lay the groundwork for a larger scale~     clinical trial to determine the efficacy of TI-MBRP.~   "
4674|NCT03505736|"~     This pilot trial studies how well a stress test works in detecting heart damage in~     premenopausal women with stage I-III breast cancer. Giving a stress test with adenosine or~     regadenoson and cardiovascular magnetic resonance imaging may help doctors detect heart~     damage caused by breast cancer treatments including chemotherapy and aromatase inhibitors.~   "
4675|NCT03505723|"~     This study is a multicentre, international, randomized controlled trial of tranexamic acid~     (TXA) versus placebo and, using a partial factorial design, of a perioperative~     hypotension-avoidance versus hypertension-avoidance strategy.~   "
4676|NCT03505710|"~     The primary objective of this trial is to evaluate the efficacy of trastuzumab deruxtecan in~     HER2-over-expressing and/or HER2-mutated advanced NSCLC subjects.~   "
4677|NCT03505697|"~     Inspiratory Muscle Training (IMT), which is used to strengthen the respiratory muscles, is~     one of the techniques used in PR. It is mostly used in patients with chronic obstructive~     pulmonary disease, and has been shown to be beneficial for functionality and also for~     relieving dyspnea perception. It is reported in the guidelines that IMT has additional~     benefit for endurance in COPD patients. However, there are no studies related to its use and~     effectiveness in lung transplantation. In this study, we hoped to increase these known~     benefits by adding IMT to the standard Pulmonary Rehabilitation.~      There are two main objectives of this study:~        1. to examine the effect of respiratory muscle training on exercise capacity in lung~          transplantation candidates,~        2. to compare dyspnea perception and lung function changes between the IMT+PR group and the~          PR group.~   "
4678|NCT03505684|"~     Comparison of a randomized, double-blind, and control-group study for the effect of oral~     ingestion of collagen tripeptides derived from fish on dermal moistures and wrinkles body fat~     reduction in participants~   "
4679|NCT03505671|"~     This pilot trial studies how well acupuncture works in reducing chemotherapy-induced~     peripheral neuropathy in participants with stage I-III breast cancer. Acupuncture may help~     reduce chemotherapy-induced peripheral neuropathy and improve quality of life.~   "
4680|NCT03505658|"~     Obesity is significantly higher in specific ethnic groups and, in particular, Hispanics.~     There is an urgent need to implement culturally-sensitive lifestyle interventions and~     educational programs to decrease the burden of obesity and obesity-related metabolic diseases~     in Hispanic populations. Accordingly, our overreaching goal is to tailor an existing and~     successful community-based program, Abriendo Caminos, to leverage effectiveness in promoting~     healthy nutrition and life-style behaviors among low income, low literacy Hispanic-heritage~     families. Our multi-function integrated project proposes to (a) adapt Abriendo Caminos for~     6-18 year-old children from Mexican and Puerto Rican heritage in five different locations~     (California, Illinois, Iowa, Puerto Rico, and Texas) and (b) Train existing professionals (in~     Extension and community agencies) and future professionals (Hispanic university students) to~     meet the specific needs of this population. Our central hypothesis is that participation in a~     6-week community-based program will prevent childhood obesity/maintain healthy weight by~     significantly increasing: (a) healthy dietary behavior patterns and basic knowledge of~     nutrition; (b) physical activity levels; and (c) the organization of collective/shared family~     mealtimes. The implementation of this culturally sensitive, workshop-based curriculum in~     different regions across the country will help to train the next generation of professionals~     in Extension and communities to deliver programs that meet the needs of Hispanic families.~     The integration of Hispanic college students in program implementation via an experiential~     learning course will further strengthen the program, as well as increase recruitment and~     retention of Hispanic students, increasing the capacity of Hispanic communities to meet their~     own needs in the future.~   "
4681|NCT03505645|"~     Study Background Osteoarthritis of the knee is a common degenerative musculoskeletal~     condition which affects nearly five million people in the United Kingdom. Some patients will~     require total knee replacement surgery if their symptoms of pain and disability are not~     controlled adequately by so-called 'conservative' measures such as weight-loss, activity~     modification and analgesic (pain-killer) medication.~      Over the past ten years our understanding of pain-relief strategies during total knee~     replacement, often termed 'Enhanced Recovery' principles, has helped improve patient care and~     reduced length of hospital admission. 'Enhanced Recovery' principles recommend the use of~     analgesic medications which can be delivered in a variety of ways e.g. tablets and~     injections. This is termed 'multi-modal' analgesia.~      Prior to total knee replacement, the patient will receive an injection around the nerves in~     the spine (regional anaesthesia) which numbs the patient from the waist down and allows the~     surgeon to perform the operation in a safe and pain-free manner. During the operation,~     surgeons often choose to deliver extra local anaesthetic to prolong the degree of pain-relief~     in the immediate post-operative period. This can enable patients to mobilise early and is~     associated with greater long-term satisfaction.~      There are two main methods of delivering this extra form of pain-relief during the operation.~     Peri-articular injection involves multiple injections of local anaesthetic into the~     soft-tissues surround the knee. In contrast, Intra-articular injection involves a single~     injection directly into the knee joint once the operation is finished. Currently, there is no~     clear evidence available to Orthopaedic surgeons to inform us which technique is better at~     providing pain relief for patients undergoing total knee replacement surgery.~      All patients undergoing total knee replacement surgery for osteoarthritis of the knee will be~     invited to participate in this study. We intend to recruit a total of 120 patients. During~     the patient's total knee replacement surgery, they shall receive an injection of local~     anaesthetic around the soft-tissues of the knee (Peri-Articular Injection) or directly into~     the knee joint itself (Intra-Articular Injection). The decision regarding which treatment~     they receive is decided entirely by randomisation.~      Following the operation, a member of the research team will assess the patient on the ward to~     collect information regarding levels of pain and overall satisfaction. The type of injection~     received shall be kept secret from both the patient and the member of the research team~     collecting the post-operative pain scores.~      After the patient has been safely discharged from hospital, we intend to follow-up all~     participants for one year. This will involve routine clinic appointments at six weeks and~     twelve months following surgery. This will involve review and clinical examination by a~     member of the orthopaedic team who have treated the patient whilst in hospital and/or a~     member of the research team.~      In addition, all patients will be asked to complete a questionnaire at twelve months~     regarding their level of function and pain. These questionnaires have been used widely in the~     medical literature and have a strong evidence base for their use.~      What is the aim of this study? The aim of this study is compare the amount of pain relief~     provided by two different methods of local anaesthetic injection techniques used in total~     knee replacement surgery. In addition, we would like to know if this influences the patient's~     immediate and long-term recovery after surgery.~   "
4682|NCT03505632|"~     For the patients undergoing laparoscopic bariatric surgery, application of low (PEEP) with~     frequent alveolar recruitment maneuver could be beneficial and superior to conventional~     ventilation with a high (PEEP) in improving lung compliance, better oxygenation and less dead~     space .This hypothesis could be achieved by minimizing the expected lung atelectasis during~     anesthesia for this particular kind of laparoscopic surgery without any haemodynamics~     alterations.This trial was designed to study the effects of alveolar recruitment strategy~     with low PEEP versus conventional mechanical ventilation with higher PEEP on the patients~     undergoing laparoscopic bariatric surgeries. The primary end point of the study will be the~     achievement of the highest dynamic lung compliance (Cdyn). Improvement of intraoperative~     oxygenation (Pao2/Fio2) and achievement of a lower dead space ratio (vd/vt), with stable~     intraoperative haemodynamics will be considered as secondary outcome~   "
4817|NCT03503851|"~     Implantation of the MitraClip has become the most frequently used percutaneous technique to~     treat significant (grade 3+ or 4+) mitral regurgitation (MR) in elderly patients deemed~     inoperable or at high surgical risk. In Europe, about two-thirds of patients treated with the~     MitraClip suffer from MR of functional origin secondary to ischemic or dilated~     cardiomyopathy. At present, there is debate among operators on whether stabilizing/supporting~     a single adequately implanted clip with a second clip is beneficial for patients with~     functional MR.~   "
4683|NCT03505619|"~     Reablement holds a potential to become a new rehabilitation model and has been implemented in~     some western countries including Norway and Denmark. At present, there is a lack of~     scientific evidence for the effectiveness of reablement and lack of an explicit theoretical~     underpinning, leading to a gap in knowledge. Trends show, however, that reablement is~     beneficial for the person and their significant others, increasing quality of life. There is~     a need for further investigation of the effects among community-dwelling adults in terms of~     clinical and economic outcomes. This research project will investigate the effectiveness of~     reablement including smart products (digitally based) (ASSIST) to facilitate and manage~     reablement services in home-dwelling adults compared with standard home help services in~     terms of daily activities, physical functioning, health-related quality of life, coping,~     mental health, use of health care services, and costs.~      Methods and analysis: This feasibility study will evaluate the perceived value and~     acceptability of ASSIST 1.0 intervention program as the fidelity, reach and dose, and~     potential outcomes by using a pre-post test design involving an intervention group and a~     control group (n=30). All participants will be living at home and with a need of home care~     services. Qualitative interviews among home care providers delivering ASSIST and older adults~     and their significant others receiving the intervention will be conducted to explore aspects~     affecting the intervention.~      Ethics and dissemination: The results will form the base for refinement of the ASSIST~     program and planning of a large-scale randomized, controlled trial investigating the effect~     of the program on quality of life as physical health, mental well-being, conditions for~     social community when focusing on supporting the older person's to meaningful everyday life.~     Dissemination will include peer-reviewed publications and presentations at national and~     international conferences.~   "
4684|NCT03505606|"~     Amblyopia, or 'lazy eye', is the reduction in vision usually in one eye, due to abnormal~     visual development without organic cause. It is a preventable and leading cause of monocular~     vision loss (prevalence of around 3%) and increases lifetime risk of bilateral visual~     impairment from 10% in the general population, to 18% in amblyopes.~      In the UK, vision screening in children aims to detect amblyopia and other undiagnosed visual~     conditions. Laboratory research suggest that amblyopia could be better detected by modifying~     standard clinical vision tests to enhance and quantify crowding. Crowding is the negative~     effect that surrounding features have on the visibility of a target. Crowding distance and~     crowding magnitude are considerably greater in amblyopic eyes than in normal healthy eyes.~     Modifications that should lead to improved amblyopia detection are 1) place letters closer~     together on a vision chart, 2) define letters by contrast, rather than luminance, and 3) use~     a new thinner font in the form of numbers, to allow crowding distance in central vision to be~     measured. In this project, these modifications will be tested in amblyopic children for the~     first time.~      Amblyopic children aged 3 to 11 years (n=32) will be recruited from ACPOS (Addenbrooke's~     Community Paediatric Ophthalmology Service) at ARU. They will have their vision measured with~     the three modified tests as well as an uncrowded test. The child will view letters and~     numbers on a computer screen and respond (verbally or by indicating their choice on a~     matching card). Testing is fun and game-like with breaks for rewards. Results will be~     compared to standard vision measurement (SLT: Sonksen LogMAR Test) from the child's ACPOS~     visit. Amblyopic data will be compared to control data from normal healthy children aged 3 to~     11 years (n=200), and age-matched children with normal vision (n=16) from ACPOS (false~     referrals from school screening).~   "
4685|NCT03505580|"~     The purpose of this study is to evaluate radiological performance of the cementless femoral~     stem AMIStem H at 1 and 5-year follow-up.~      All the patients operated at the investigational sites between April 2009 and April 2012 will~     be reviewed at 1, 5 and 10 year according to standard practice~   "
4686|NCT03505567|"~     This study is a prospective comparative study to gather pilot agreement and precision data in~     normal subjects, subjects with glaucoma, and subjects with retinal disease.~   "
4687|NCT03505554|"~     The purpose of this study is to define the objective response rates (ORR) of Lorlatinib in~     subjects with ALK+ lymphomas resistant or refractory to ALK inhibitors.~   "
4688|NCT03505541|"~     Investigate the effect of two adipokines which are adiponectin and TNFa on the force of~     myometrial contractility in diabetic, non-obese pregnant women and obese, non-diabetic term~     pregnant women at the time of scheduled cesarean delivery~   "
4689|NCT03505528|"~     This phase 1b study will determine the safety and efficacy of combined treatment of Abraxane~     and phenelzine sulfate (Nardil) for metastatic or locally advanced breast cancer.~      Participants may be eligible to join this study if they are aged 18 years or above and have~     been diagnosed with metastatic breast cancer or inoperable locally advanced breast cancer.~      All participants will receive a combination of intravenous Abraxane and an oral dose of~     phenelzine sulfate. Abraxane will be administered weekly for the first 3 weeks of a 4-week~     cycle for 3 consecutive cycles. Phenelzine sulfate will be taken daily for the duration of~     the 3 cycles. Five patient cohort groups will receive a progressively increasing dose of~     phenelzine sulfate. Safety and efficacy will be assessed weekly over the 3 cycles of~     treatment.~      Although both drugs have been used in clinical care for more than a decade, they have not~     been intentionally combined together in a cancer therapy setting. This means that the~     combined effect of these two drugs has not been documented. This is being addressed in this~     study.~   "
4690|NCT03505515|"~     The purpose of the study is to document real-world pattern of care, outcomes and health~     resource use for patients diagnosed with and receiving treatment for advanced Non-small cell~     lung cancer (NSCLC) and extensive disease Small cell lung cancer (SCLC) in China.~   "
4691|NCT03505502|"~     This study was a double-blinded randomized controlled study conducted at Aswan University,~     Egypt from January 2018 to January 2020. Study inclusion criteria were women who attended the~     outpatient obstetric clinic, seeking antenatal care diagnosed with leiomyomas with pregnancy~     and with myoma staging from (3 to 6) according to FIGO staging. scheduled to undergo cesarean~     myomectomy (11) Exclusion criteria were: 1-Patients undergone vaginal delivery.2-Patients~     with a history of thromboembolic disease. 3-Cervical and broad ligament myoma. 4-Myoma FIGO~     staging~   "
4692|NCT03505489|"~     The study will assess how the inhalation technique used (deep inhalations versus tidal~     breathing) influences the results of a mannitol challenge test and a methacholine challenge~     test, if at all.~   "
4693|NCT03505476|"~     The research proposed in this study will develop a noninvasive prototype device that will~     capture intestinal sounds, process signals, and display predictive information in real-time~     at the point-of-care using algorithms already developed at this institution.~   "
4694|NCT03505463|"~     The study is a prospective cohort study designed to assess the diagnostic and prognostic~     potential of biomarker measurement in acute traumatic spinal cord injury (TSCI), and to~     examine the neuroinflammatory response to acute TSCI.~   "
4695|NCT03505450|"~     This study will be nested as a randomized controlled trial within an online Delphi and will~     assess the effects of the population sampling compared to purposive sampling for consensus in~     an online Delphi.~   "
4696|NCT03505437|"~     This study investigates whether stress can augment exposure therapy outcome in patients with~     specific phobia (spider phobia).~   "
5493|NCT03494959|"~     To demonstrate that the early addition of Pentaglobin to the best available antimicrobial~     therapy is able to reduce mortality and improve survival in neutropenic febrile acute~     leukemia or allo- Hematopoietic stem cell transplantation (HSCT) patients colonized by~     carbapenem-resistant Enterobacteriaceae or by any Pseudomonas aeruginosa.~   "
4700|NCT03505385|"~     Background. There is a growing demand for long-term care settings. Care-home residents are a~     vulnerable group with high levels of physical dependency and cognitive impairment. Long-term~     care facilities' policy need to adapt and offer more effective and sustainable interventions~     to address their complex physical and mental health needs. Despite the increasing emphasis on~     patient and public involvement, marginalised groups such as care-home residents, can be~     overlooked when including people in the research process. The GET READY project aims to~     integrate service-learning methodology into Physical Therapy and Sport Sciences University~     degrees by offering students individual service opportunities (placements) with residential~     care homes, in order to co-create the best suited intervention with researchers, older adults~     of both genders (end-users) in care homes, health professionals, caregivers, family members~     and policy makers.~      Methods. Stage 1 will integrate a service-learning methodology within a Physical Therapy~     module in Glasgow and Sport Sciences module in Barcelona, design two workshops for care home~     residents and conduct a co-creation protocol. Stage 2 will assess the intervention~     feasibility, safety and preliminary effects of the co-created intervention in a group of 60~     care home residents, within a two-armed pragmatic randomized clinical trial.~   "
4701|NCT03505372|"~     This research study is studying whether contrast enhanced mammography can predict if atypical~     ductal hyperplasia will progress to cancer.~      The device involved in this study is:~      -Contrast enhanced mammography~   "
4702|NCT03505359|"~     Introduction: Individuals with an ACL lesion present abnormal rotational stability. Among the~     structures located in the anterolateral region of the knee that could act as restraints of~     the rotational knee lassitude, there is the Anterior Lateral Ligament (ALL), and its~     reconstruction associated with ACL reconstruction could reduce recurrence injury rates.~     Objective: to develop a rehabilitation protocol for patients undergoing combined~     reconstruction of ACL and ALL. METHOD: Articles published with patients submitted to ACL~     reconstruction with an anatomic technique and flexor tendon graft, (which is the same one~     adopted in this study), were selected as a base to this protocol. Discussion: The results~     will provide important information on clinical practice, since it can help identify the~     necessity or not of restraining the knee range of motion in combined surgeries. It can guide~     the therapeutic planning, including the cost of knee restraint devices, in addition to~     estimating these patients prognosis. The protocol with partial restriction of knee range of~     motion in the first 6 weeks of postoperative is the most indicated program in the~     rehabilitation of the combined surgeries of ACL and ALL reconstruction.~   "
4703|NCT03505346|"~     The aim is to examine the expression of αvβ3 integrin using a novel selective radiotracer in~     patients with chronich ischemic heart disease and investigate if it is a suitable tool for~     predicting myocardial recovery and thus prognosis after intervention.~   "
4704|NCT03505333|"~     Liga Sure represents a novel principle for hemostatic sealing of vessel-containing tissue~     based on feedback-programmed dosage of bipolar diathermy.(5) According to marketing of the~     device, Liga Sure has the potential to replace the use of conventional suture ligature within~     a broad range of surgical procedures, also including removal of the uterus. While the use of~     Liga Sure has been critically assessed for a range of procedures such as hemorrhoidectomy,~     splenectomy, bile duct, urological and gastric operations,(6-12) a similar scientific~     evaluation of its suitability for abdominal removal of the uterus is lacking in the~     literature. The most promising aspect of Liga Sure in hysterectomy is the potential shorter~     operation time and decrease blood loss. Because removal of the uterus traditionally is the~     most frequently performed major gynecological operation,(13) the introduction of a~     time-sparing new technique could have significant impact on resource consumption.~      The aim of the study:~      we aimed at evaluating the use of Liga Sure compared with conventional suture ligature during~     abdominal hysterectomy, in a prospective randomized controlled trial with special emphasis on~     the safety, the duration of the procedure and the amount of blood loss.~   "
4705|NCT03505320|"~     The purpose of this study is to determine the Objective Response Rate (ORR) of IMAB362 as a~     single agent as assessed by an independent central reader. This study will also assess the~     ORR and Progression Free Survival (PFS) of IMAB362 in combination with mFOLFOX6, assess the~     safety and tolerability, assess the effects on CLDN18.2 expression and assess the~     immunogenicity and immunomodulatory effects of IMAB362 as a single agent and in combination~     with mFOLFOX6. This study will also evaluate the pharmacokinetics (PK) of IMAB362,~     oxaliplatin and fluorouracil (5-FU), evaluate health-Related Quality of Life (HRQoL),~     evaluate the Disease Control Rate (DCR), Duration of Response (DOR), PFS and Overall Survival~     (OS) of IMAB362 as a single agent.~   "
4706|NCT03505307|"~     [Objectives] Objectives include following to capture safety and efficacy of LYNPARZA in~     actual clinical use.~        1. ADR development in actual clinical use~        2. Factors which may affect safety and efficacy~        3. ADRs not expected from Precautions for Use.~   "
4707|NCT03505294|"~     It is reported that 85% of MS patients have gait disturbance, 87.9% balance, 35-90% fatigue~     and 45-60% cognitive problems. Rehabilitation approaches based on the motor control systems~     model, the plasticity concept, the motor learning principles, have been found to be effective~     for solving these problems. With these rehabilitation approaches, it is aimed to develop the~     ability of the person to meet the task and environmental demands and to realize the highest~     quality and the right function with maximum potential by consuming the least energy in~     different environmental conditions of different tasks. Task-oriented training may be one of~     the most effective among the evidence-based rehabilitation approaches for these goals.~      The purpose of this study is to determine the effect of Task-Oriented Training on the~     physical and cognitive functions in patients with multiple sclerosis.~   "
4765|NCT03504540|"~     The rationale of this research is to determine if patients with lupus and presenting retinal~     pseudo-drusen-like deposits have genetic and complement-related similarities with AMD~     patients.~      Based on the results obtained, this study could lead to future research that could better~     target the treatment of patients with lupus or patients with AMD (Age related Macular~     Degeneration).~      The primary objective is to check if patients with lupus, treated or not with antimalarial~     drugs, with pseudo-drusen-like deposits have a different complement profile (functional~     exploration of complement, complement factors, genetic complement polymorphisms involved in~     AMD) compared to patients without pseudo-drusen-like deposits.~   "
4708|NCT03505281|"~     Lower respiratory infections, or pneumonia, remain the third leading cause of death~     worldwide, despite progress in vaccinating at-risk populations and improved resuscitation~     techniques.~      Research shows that immune defences are weakened during severe infections. This immune~     weakening could alter resistance to bacterial infection and facilitate death, but also~     facilitate the onset of secondary infections.~      Through this study, investigators wish to evaluate a biomedical test (derived from a blood~     sample - Quantiferon Monitor test), aimed at measuring the immune response of certain immune~     cells (lymphocytes).~      The objective of the study is to determine whether this test can predict the occurrence of~     death during pneumonia.~      If this hypothesis is verified, it would make it possible to use this test as a marker to~     identify patients at risk of death, and would open up new therapeutic prospects in order to~     provide patients with severe pneumonia with a treatment that stimulates their immune~     defences.~   "
4709|NCT03505268|"~     This study evaluates the effect of telemedicine intervention program upon glycemic control in~     type 1 diabetes mellitus children and their parents in Israel. Half of the participants will~     receive the telemedicine intervention for a period of six months while the other half will~     receive the regular treatment then vice versa. Each group will receive in the intervention~     period 6 telemedicine meeting with a dietician and six telemedicine meetings with a nurse.~      The investigators hypothesized that the participants that are recieving the telemedicine~     intervention will have a better glycemic control after 6 months.~   "
4710|NCT03505255|"~     The goal in this work is to compare between the effects of intraperitoneal versus~     intramuscular neostigmine on pattern of postoperative GIT motility in patients undergoing~     laparoscopic cholecystectomy~   "
4711|NCT03505242|"~     Both left single lung ventilation by left double lumen tube and bilateral ventilation with~     selective blockage of right middle lower lobe by bronchial blocker can provide suitable~     surgical field for minimally invasive cardiac surgery. The current study was designed to~     compare the impact of these two different methods on oxygenation, degree of pulmonary~     collapse and postoperative complications.~   "
4712|NCT03505229|"~     To assess the freedom from local failure at 12 months after Stereotactic Body Radiotherapy~     (SBRT). Also to assess the safety, efficacy and feasibility of SBRT in the treatment of high~     risk localised pancreatic cancer.~   "
4713|NCT03505216|"~     The Swiss Paediatric Airway Cohort (SPAC) is a national, prospective clinical cohort of~     children and adolescents who visit physicians in Switzerland for recurrent wheeze, cough, and~     exercise- or sleep-related respiratory problems. SPAC aims to answer important questions on~     clinical phenotypes, prognosis, diagnosis and treatment. SPAC is part of routine care, and~     only clinically indicated investigations are done. The comprehensive baseline assessment~     includes a detailed questionnaire to families, plus test results, diagnoses and treatments~     from hospital records. Follow-up is via annual questionnaires to families, monthly mobile~     phone symptom scores, and data from follow-up visits.~      Currently, 350 patients from four major hospitals (Bern, Zurich, Basel and Lucerne) have been~     enrolled, but other clinics and practices will join and the investigators aim for at least~     3000 patients.~      SPAC will provide real-life data on children visiting the Swiss health care system for common~     respiratory problems. It will provide a research platform for health services research, and~     for nested clinical and transitional studies.~   "
4714|NCT03505203|"~     Rapid weight gain during infancy is a powerful, and potentially malleable, risk factor for~     later overweight and obesity, but limited research has examined the impact of promising~     interventions when applied to the groups most at risk for rapid weight gain in infancy. The~     present study examines whether providing mothers of newborns with responsive parenting~     guidance during the first weeks of life to promote infant sleep and soothing can reduce rapid~     weight gain for African American infants born in low SES contexts.~   "
4715|NCT03505190|"~     This randomized study will evaluate the safety, tolerability and pharmacokinetics of single~     ascending subcutaneously administered doses of RO7062931 in healthy volunteers.~   "
4716|NCT03505177|"~     The aim of this research study is to characterize gut microbiota composition and activity~     after a daily supplementation of 4.5 g of chitin-glucan during 3 weeks. For this purpose, a~     monocentric longitudinal intervention study without control will be performed. Fecal~     microbiota composition and fecal concentrations of gut microbiota-derived metabolites (bile~     acids, conjugated-polyunsaturated fatty acids and short-chain fatty acids) will be measured.~     In addition, during ten hours following the ingestion of a test meal rich in fibers, the~     kinetic of production of H2, methane and volatile compounds exhaled from breath will be~     evaluated.~   "
4717|NCT03505164|"~     This study looks to find a causative or predictive aspect of the suPAR biomarker for heart~     failure in breast cancer patients receiving Doxorubicin drug chemo regimen.~      suPAR is a circulating protein which can be found in blood and/or urine and is associated~     with both kidney and heart disease.~        -  Hypothesis 1: Higher suPAR at baseline will predispose to Doxorubicin-induced~          cardiomyopathy or heart failure, observed by histology (under the microscope and other~          lab techniques) in mouse models, and tested using heart ultrasound techniques in humans.~        -  Hypothesis 2: suPAR is a marker of Doxorubicin-induced cardiomyopathy or heart failure~          after exposure to Doxorubicin, observed by histology (under the microscope and other lab~          techniques) in mouse models, and tested in humans.~      The study will look at suPAR's association with three other biomarkers called troponin,~     B-Type Natriuretic Peptide (BNP) and C- Reactive Protein (CRP) that are also associated with~     heart disease.~      In this study, the patient will have blood drawn as a routine part of the cancer treatment.~     That is prior to starting the cancer therapy, then after the first 2 and last 2 doxorubicin~     cycles (4 cycles altogether); as well as at 3, 6, & 12 months after doxorubicin treatment. (6~     Visits in total) The patient will also have an echocardiogram (echo, heart ultrasound) at~     each of these time points. The first of the six study echos is considered part of the routine~     care.~   "
4718|NCT03505151|"~     The primary objective of this trial is to investigate the absolute bioavailability of BI~     409306. The secondary objective is the evaluation and comparison of several pharmacokinetic~     parameters for the different treatments.~   "
5494|NCT03494946|"~     The trial is a randomized control trial. Patients are randomized between Ltx and other~     treatment that may include further chemotherapy, TACE, SIRT or other available treatment~     options. The patients will be randomized 1:1 to Ltx and chemotherapy/other treatment options.~   "
4719|NCT03505138|"~     The prevalence of COPD is high and suppose one of the first public health problem in the~     world. It has a high morbidity and mortality and healthcare costs. The economic aspect is~     directly related to hospitalization, accounting for 45-50% of total expenditure of COPD.~     Patients with frequent exacerbations generate most of the cost.~      In these patients, there are not standardized treatments or monitoring in a medium or long~     term, but it seems reasonable that the combination of various interventions (programs~     self-care, active role of health professionals in consultations, home programs, group visits,~     establishment action plans for patients, use of communication technologies or social~     networks) may improve many patient outcomes.~      The hypothesis of our work will be to introduce telemedicine platform to establish action~     plans for the patient, recognition of symptoms and exacerbations, treatments for the~     exacerbations, training material on COPD, smoking and inhalation therapy, establishment of a~     fast and fluid communication with pulmonologist, with the purpose of responding to various~     health problems that patients with COPD (exacerbator phenotype or ACO phenotype) may have. We~     will study the impact of this tool to reduce the rate income or readmission for the patients~     with COPD, analyzing it from the perspective of cost-effectiveness.~   "
4720|NCT03505125|"~     The 165-901 study is designed to identify the appropriate tools for use in future~     interventional studies on the neurocognitive effects of pegvaliase on adults with PKU.~   "
4721|NCT03505112|"~     Goal-directed therapy (GDT) has been applied to various clinical settings and has been widely~     researched recently as a method for perioperative management of patients. Radical cystectomy~     is a complex surgical procedure in which the bladder is removed, followed by urinary~     diversion. It is an extensive and time-consuming intervention and has high probability of~     fluid imbalance and bleeding during surgery. We hypothesized that the application of GDT in~     these patients would improve clinical postoperative outcomes. Therefore, we will attempt to~     evaluate improvement of postoperative outcomes after applying GDT protocol based on changes~     in stroke volume index, cardiac index and mean arterial pressure in radical cystectomy.~   "
4722|NCT03505099|"~     A global study of intravenous AVXS-101 in pre-symptomatic patients with SMA with 2, 3, and 4~     copies of SMN2~   "
4723|NCT03505086|"~     Multicenter case cohort study investigating clinical risk factors for clinically relevant~     bleeding in hemato-oncology patients, as well as bleeding related biomarkers during intensive~     treatment.~   "
4724|NCT03505073|"~     Detection of Prevalence of silent atrial fibrillation in patients with Mitral stenosis and~     sinus rhythm and its correlation with the presence of left atrial thrombus.~   "
4725|NCT03505060|"~     The purpose of this study is to evaluate the safety and immunogenicity of the IHV01 protein~     vaccine primed and co-administered with HIV DNA CON-S env vaccine in healthy,~     HIV-1-uninfected adults.~   "
4726|NCT03505047|"~     The main objective of the study is to compare use, in a randomised controlled trial, of the~     the copper IUD if inserted immediately after completion of a second trimester medical~     abortion, to standard care with insertion 3-4 or more weeks after abortion at community~     health centres.~   "
4727|NCT03505034|"~     This study aim to evaluate the safety and efficacy of intrathecal transplantation of~     allogeneic umbilical cord derived mesenchymal stem cells (UC-MSC) for treatment of different~     phrases of spinal cord injury. Here, the history of spinal cord injury is divided into three~     periods, Sub-acute SCI, Early stage of chronic SCI, and Late stage of chronic SCI, which is~     2W-2M, 2M-12M, and more than 12M after injury, respectively. The purpose is to investigate~     whether the patients with spinal cord injury benefit from UC-MSC transplantation, and then~     find out the best time for SCI treatment.~      In this part of the study, the investigators will treat patients with late stage of chronic~     spinal cord injury with UC-MSC transplantation or placebo.~   "
4728|NCT03505021|"~     In the randomized, double-blind, placebo-controlled, parallel-group, multicentre study,~     ODM-109 capsules and placebo capsules for ODM-109 is administered for 48 weeks. The subjects~     are allocated to 2 parallel groups receiving either levosimendan 1-2 mg daily or placebo in~     2:1 ratio. There is a screening visit, a baseline visit followed by visits at 2, 4, 8, 12,~     24, 36 and 48 weeks, and telephone contacts during weeks 18, 30 and 42. An end-of-study visit~     takes place 14-25 days after the last study treatment administration for each subject. The~     total study duration for each subject is about 51-52 weeks including the end-of-study visit.~      The planned number of study subjects is approximately 450.~      Primary objective is to confirm that levosimendan can significantly improve respiratory~     function in patients with amyotrophic lateral sclerosis (ALS).~   "
4729|NCT03505008|"~     This study will be conducted in Japan, South Korea and Taiwan to evaluate the optimal dosage~     of methotrexate (MTX) as an add-on therapy to adalimumab (ADA) in participants with~     rheumatoid arthritis (RA) who have not achieved remission by MTX monotherapy.~   "
4730|NCT03504995|"~     The purpose of this study is to evaluate safety and short-term oncological efficacy of the~     NanoKnife Irreversible Electroporation System for localised prostate cancer.~      Irreversible electroporation (IRE) is the method of focal treatment for prostate cancer,~     which is already proven by FDA as method of the surgical ablation of soft tissue. It has not~     received clearance for the therapy or treatment of any specific disease or condition.~   "
4731|NCT03504982|"~     The objective of this study is to evaluate the effect of multiple doses of vericiguat on the~     QTc interval in patients with stable CAD (coronary artery disease).~   "
4732|NCT03504969|"~     Umbilical Cord Entanglement and Perinatal Outcomes.~   "
4733|NCT03504956|"~     This study proposes to develop an MRI technique named Coronary Atherosclerosis T1-weighed~     Characterization (CATCH) that will improve the quality and reliability of coronary~     atherosclerosis evaluation, as well as simplify the scanning process and significantly~     shorten imaging time compared with conventional imaging methods.~   "
4734|NCT03504943|"~     The objective of this study is to compare the rate of low blood pressure events~     (Intradialytic Hypotension: IDH) when intradialytic exercise is performed in the first half~     of the hemodialysis (HD) session as compared to that when intradialytic exercise is performed~     in the second half of the HD session. The investigators expect that there will be little to~     no difference in occurrence of IDH episodes between the two time periods based on the~     experience of the 3 centres and imaging studies of the heart with exercise in HD.~   "
20076|NCT03304184|"~     The study will compare two different dental materials on dental lesions near the gum line~     that cause chronic pain on oral health related quality of life.~   "
4735|NCT03504930|"~     The surgical treatment of the ulcerative colitis (UC) remains associate to a significant~     morbidity (up to 60%). Anastomotic fistula and pelvic sepsis are the most severe~     complications which could dramatically compromise the surgical issue and functional status.~     Thanks to the current therapeutic arsenal and the evolution of health care paradigms, the~     quality of life of patients plays a key role in the modern global management of these medical~     conditions. Biotherapies (e.g anti-TNF) are widely used to treat patients with UC. Anti-TNF~     and anti-integrins have an effect on the immune response and can theoretically aggravate the~     infectious disease. Their potential impact on postoperative complications after ileo anal~     anastomosis (AIA) remains debated. Very few studies have looked at other biotherapies~     including vedolizumab. All studies are retrospective series with small sample size. Here~     again the conclusion remain contradictory. Lightner et al. showed an increased risk of~     surgical site infection for patients preoperatively exposed to vedolizumab (37% vs. 10%, p~     <0.001). In a dedicated cohort to the RCH, the same author found a risk of increased pelvic~     abscess (31.3% vs 5.9%, NS) but the difference was not statistically significant probably for~     lack of power. Other studies did not find any impact of vedolizumab on the risk of~     postoperative complications. To clearly determine within a large prospective cohort the~     impact of anti-TNF agents and biotherapies on the postoperative complications seems to be~     essential in order to adapt and to optimize the therapeutic strategy, especially the surgical~     sequences, in patients with UCR whom benefit a surgery.~   "
4736|NCT03504917|"~     This study will evaluate the efficacy, safety, and pharmacokinetics of 10 mg of oral~     administration balovaptan once a day (QD) compared with matching placebo in adults (18 years~     and older) with autism spectrum disorder (ASD).~   "
4737|NCT03504904|"~     This trial is a randomized controlled study aiming to investigate the effect of an 8-week~     internet-based intervention focused on acceptance and compassion or a wait-list control~     group. Primary treatments outcomes are Chronic Pain Acceptance Questionnaire (CPAQ),~     Self-Compassion Scale (SCS) and Pain Disability index (PDI). Secondary outcomes were~     Montgomery Åsberg Depression Rating Scale (MADRS-S), Anxiety sensitivity index (ASI), Quality~     of Life Inventory (QOLI), Multidimensional Pain Inventory (MPI) and Perseverative Thinking~     Questionnaire (PTQ). A six month follow-up was conducted. Findings showed significantly~     greater levels of acceptance (CPAQ), self-compassion (SCS) and reduction in activity~     limitation (PDI) measured with the primary outcomes for the treatment group after the~     intervention with effect sizes raging from small to moderate and these results were~     maintained at six-month follow-up.~   "
4738|NCT03504891|"~     This study will investigate the use of cardiac MRI in patients with standard ICDs and~     pacemakers to inform how cardiac resynchronization therapy (CRT) can best be implemented in~     these patient and which patients are the best candidates for CRT.~   "
4739|NCT03504878|"~     In the world, there are several studies comparing the cost-effectiveness between laparoscopic~     appendectomy and open appendectomy. But in Vietnam, health economics studies for acute~     appendicitis surgery in general and laparoscopic appendectomy in particular has hardly been~     available, and in the context of reform of the financial mechanism for payment, questions~     about the cost-effectiveness between the two surgical methods are particularly concerned.~     Therefore, we conducted a study Cost-effectiveness analysis and case-based payment norm~     modeling in patients with appendectomy at Hanoi Medical University Hospital~   "
4740|NCT03504865|"~     This is a randomized, single-blinded placebo-controlled trial.~      Patients will be randomized to one of three arms: (1) injection of liposomal bupivacaine at~     the end of the operation, (2) injection of standard bupivacaine at the end of the operation,~     or (3) no injection of local anesthetic. All patients will be able to receive IV and oral~     narcotic medications in the postoperative period on an as-needed basis.~      If a patient is randomized to the LB arm, at the appropriate time, under a surgeon's~     direction, 266 mg of (liposomal bupivacaine) LB in 20 cc of solution was expanded with~     various amounts of normal saline to cover the appropriate surgical field. Our routine~     expansion for a bilateral mastectomy is to add 80 mL of saline to 20 mL (266 mg) of LB. In~     our practice,we use an 18-gauge needle to inject the medication in a field-effect~     encompassing all 4 quadrants of the chest muscles (pectoralis and serratus) followed by~     injecting around the edges of the skin incision and drain site. This occurs prior to~     dissection of the pectoralis muscle and implant or tissue expander placement.~      Patients randomized to the SB arm will receive weight-based dosing of bupivacaine,~     administered in the same manner as the LB arm.~      Patients who are in the placebo arm will have a similar volume of saline injected into the~     operative site.~      Postoperatively, all patients will be kept in the hospital for at least one night. Total~     length of stay will be documented. They will all have the option of receiving IV morphine~     injections as well as oral acetaminophen-hydrocodone as needed for additional pain control.~     The administration of these additional medications will be recorded for each patient.~      On postoperative day 1, each patient will be administered the American Pain Society Outcome~     Questionnaire while in the hospital. After discharge from the hospital, we will call the~     patient on postoperative day 2, 3, 5 and 7 to assess pain and satisfaction scores, using the~     same questions each time. For any patients staying in the hospital longer than 1 day, the~     questionnaire will be administered in the hospital on the same postoperative days. Subject~     participation only lasts for these 7 days of follow up.~   "
4741|NCT03504852|"~     Demonstrate superiority of secukinumab high dose over standard dose in heavy body weight~     subjects with moderate to severe plaque psoriasis.~   "
4742|NCT03504839|"~     Design: Prospective, non-randomized single center study at The Ohio State University Wexner~     Medical Center.~      Purpose: The purpose of this study is to prospectively evaluate a specific analgesia protocol~     designed to allow for same day discharge following implantation of the subcutaneous~     implantable cardiac defibrillator (S-ICD) Enrollment: Up to 40 subjects will be enrolled.~     Subject Population: Consecutive patients undergoing S-ICD implantation under general~     anesthesia or monitored anesthesia care.~      Endpoints: Rate of successful completion of the protocol; Procedural complications; Serial~     assessment of patient perception of pain.~   "
4743|NCT03504826|"~     Locomotor training is an established rehabilitation approach that is beneficial for improving~     walking function in individuals with spinal cord injuries (SCIs). This approach focuses on~     repetitive practice and appropriate stepping movements to activate spinal neural networks and~     promote rhythmic motor output associated with walking. Assistance with stepping movements is~     often provided by physical therapists and trainers, but this can be costly and difficult to~     deliver in the cost-constrained U.S. healthcare market. Robotic devices have been used as an~     alternate method to deliver locomotor training, but current robotic approaches often lack the~     natural movement variations that characterize normal human stepping. Furthermore, studies to~     compare locomotor training approaches have not shown any specific benefits of using robotic~     devices. A new type of robotic device has emerged that uses an individual's muscle activation~     and stepping movements to control the robot during walking. This adaptive robotic device~     adjusts to the user's intentions and can assist with stepping during locomotor training in a~     manner that matches natural human stepping. While this type of adaptive robot has been~     preliminarily tested, the safety and efficacy of locomotor training using adaptive robotics~     are not well-established in patients with SCI. This is a critical step to determine if~     individuals with SCI may benefit from use of this device and for preliminary adoption of this~     technology. Recent studies have used the Cyberdyne Hybrid Assistive Limb (HAL) to deliver~     locomotor training and have reported outcomes suggesting that the HAL adaptive robot is safe~     and efficacious for walking rehabilitation in European SCI patients. Therefore this study~     will use the HAL adaptive robot to deliver locomotor training. This research is necessary to~     determine if use of the HAL is potentially beneficial and warranted for use with locomotor~     training and SCI patients receiving care in the U.S. Results of this study may contribute to~     the development and implementation of effective walking rehabilitation approaches for people~     with SCIs.~   "
4744|NCT03504813|"~     Introduction: The progressive aging of the population is a socio-demographic phenomenon~     experienced by most countries in the world in recent decades, especially in Japan and in many~     European Union countries. During this process, so-called geriatric syndromes frequently~     occur. The focus of this study is the quality of life of the elderly in relation to these~     three factors: risk of falls, urinary incontinence, and insomnia.~      Objective: The main purpose is to determine the impact of a multifactorial intervention~     program implemented with institutionalized elderly people. The program is focused on the~     treatment of the aforementioned factors.~      Methods and Analysis: The study will be carried out with elderly people living in three~     residences for the elderly in A Coruña Province (Galicia, Spain).~      It is a prospective and longitudinal study, with a temporary series design of a~     quasi-experimental type that evaluates the effect of an intervention in one given~     population by doing assessments pre- and post-intervention, but there is no comparison with a~     control group.~      The intervention will be based on a multifactorial program, including the following phases:~     the use of wearable devices (wearable fitness trackers to register physical activity and~     sleep), the use of an App on a Tablet to record the participants' occupations and activities,~     counseling about performance in activities of daily living, the implementation of a physical~     activity program, and the treatment of the pelvic floor (according to each research line).~     The Quality of Life (QoL) will be assessed before and after the intervention, with the use of~     the questionnaire EuroQol-5D-5L. Data analysis will be applied with all registered variables~     through a quantitative perspective.~   "
4745|NCT03504800|"~     This main goal of this study is to improve the detection, classification, monitoring, and~     treatment of irregular corneas due to keratoconus, warpage, dry eye, scar, stromal~     dystrophies, and other corneal conditions.~      The primary goal will be achieved by using optical coherence tomography (OCT) to:~        1. Develop an OCT-based system to classify and evaluate corneal-shape irregularities.~        2. Develop OCT metrics for more sensitive detection of keratoconus progression.~        3. Develop OCT-and-topography guided phototherapeutic keratectomy (PTK) for irregular~          corneas.~   "
4746|NCT03504787|"~     The aim of the study was to determine upper extremity selective motor control (SMC) in~     Children with Unilateral Cerebral Palsy (CP). It was also aimed to determine the relationship~     between upper extremity SMC and upper extremity functions in unilateral CP.~   "
4747|NCT03504774|"~     A prospective Phase 2, single-center, single-allergen OIT in milk or cashew or shrimp in~     participants with proven allergies to either milk or cashew or shrimp, respectively. OIT~     treatment groups will be milk, cashew, or shrimp.~      After determining their specific food allergen (cashew, milk, or shrimp), subjects will~     undergo a dose escalation day to reach 5 mg allergen, after which they will return to the~     clinic every 2 weeks to escalate their allergen dose to reach a 300 mg dose at week 21.~     Participants then will be maintained at that dose for 3 weeks (Maintenance Phase).~     Participants that pass a Double Blind-Placebo Controlled-Food Challenge (DBPCFC) at the end~     of their maintenance period (week 21) will be declared desensitized and will continue in the~     study for 6 more weeks to examine mechanisms underlying sustained unresponsiveness (SU) by a~     second DBPCFC at week 30. Participants then will be followed for additional 8 weeks to reach~     the end of study phase (Week 38).~   "
4748|NCT03504761|"~     The purpose of this study is to demonstrate the effectiveness and safety of the ClariCore~     System in obtaining prostate biopsies with device feedback that provides real-time tissue~     classification.~   "
4749|NCT03504748|"~     Pain is the most prevalent non-motor symptom in Parkinson disease, and the motor improvement~     not always is related to the pain improvement with the medication treatment. By this, we are~     testing a non-invasive method called transcranial magnetic stimulation as an alternative to~     treat pain related to Parkinson disease. This technique can lead to either inhibitory or~     excitatory effects in brain circuits depending on stimulation parameters, and is known to~     provide analgesic effects.~   "
4750|NCT03504735|"~     To evaluate the effectiveness of Caduet in addition to therapeutic life-style change (TLC)~     intervention in resolving metabolic syndrome fifty three individuals were randomized to TLC~     intervention study with or without Caduet therapy for 12 months. The participants underwent~     monthly visits with investigators to obtain vital signs, and to undergo TLC counseling.~     Metabolic parameters were measured before and after intervention.~   "
4751|NCT03504722|"~     To develop and pilot test feasibility, acceptability, and efficacy of an adjunct intervention~     for use with Empirically Based Treatments (EBT) for posttraumatic stress disorder (PTSD) in~     order to increase treatment engagement, treatment completion, and improve treatment response~     regarding emotional numbing symptoms. Recovery through Engagement with Shelter Canines,~     Understanding, and Exposure (RESCUE), is an adjunctive, Human Animal Interaction (HAI)~     intervention that will be developed for integration into Prolonged Exposure (PE) treatment.~     Feasibility, acceptability, and initial efficacy testing of the experimental treatment~     condition will be conducted in a pilot crossover randomized controlled trial (RCT) conducted~     with 75 veterans with PTSD randomly assigned to RESCUE delivered with PE (RESCUE+PE) or to~     standard PE initiation (PE + delayed RESCUE).~   "
4752|NCT03504709|"~     The aim of this study is to assess the utility of advanced magnetic resonance imaging (MRI)~     and electroencephalographic (EEG) technologies for predicting functional outcomes in patients~     with severe traumatic brain injury (TBI).~   "
4753|NCT03504696|"~     This study will be conducted with the aim of estimating the effectiveness, safety, patterns~     of use of nivolumab, and characteristics of patients with unresectable or metastatic~     melanoma, treated with nivolumab monotherapy in the ATU setting.~   "
4766|NCT03504527|"~     This study evaluates the efficiency of ICS(budesonide) combined with LABA (formoterol) and~     LAMA(tiotropium) in the treatment of acute exacerbation of asthma-chronic obstructive~     pulmonary overlap. Half of participants will receive budesonide,formoterol and tiotropium in~     combination, while the other half will receive budesonide and formoterol only.~   "
4898|NCT03502798|"~     The purpose of this study is to develop a low coherence interferometry (LCI) endoscopic probe~     that can examine the cervix for evidence of cervical dysplasia. The device will make optical~     measurements of the cervix to determine:~        1. the difference between two different types of cervical cells: ectocervical cells and~          endocervical cells. Cervical dysplasia is most likely to occur at the junction between~          these two types of cells.~        2. features of individual cervical cells that indicate whether the cell is normal or~          abnormal (cervical dysplasia).~   "
4754|NCT03504683|"~     One in three American adults have prediabetes, and up to 70% of adults with prediabetes~     eventually develop type 2 diabetes. With the high cost of treating diabetes, cost-effective~     approaches are needed to reduce the incidence of diabetes. One new strategy may be to change~     when people eat. Studies in rodents suggest that a form of intermittent fasting that limits~     eating to a short time period each day and involves fasting for the rest of the day~     (time-restricted feeding; TRF) improves blood sugar control and cardiovascular health.~     Preliminary studies suggest that TRF also improves blood sugar, weight loss, and~     cardiovascular health in humans. This study will be the first full-scale, controlled feeding~     trial to determine whether TRF can improve 24-hour blood sugar control, 24-hour blood~     pressure, and cardiovascular disease risk factors even when food intake is matched to the~     control group. This clinical trial will also determine whether the benefits of TRF depend on~     the time of day that people eat. Participants will be assigned to one of three groups: (1)~     'Early TRF' (eat between ~8 am-3 pm), (2) 'Mid-day TRF' (eat between ~1 pm - 8 pm), or (3)~     Control Schedule (~8 am - 8 pm) for 10 weeks. All food will be provided and matched between~     groups.~   "
4755|NCT03504670|"~     Artificial rupture of membranes (amniotomy) is a commonly used technique to safely induce and~     augment labor. It has been shown to reduce the duration of spontaneous and induced labor in~     term patients (≥37 weeks' gestation). The utility of amniotomy in preterm patients (<37~     weeks' gestation) undergoing medically-indicated induction of labor is unknown. However, it~     remains a commonly used strategy. We will conduct a trial comparing early amniotomy versus~     late amniotomy during medically-indicated induction of labor between 23.0 and 35.6 weeks~     gestation. Women will be randomized to early or late amniotomy after the obstetrician has~     decided to induce labor for a medical indication. We hypothesize that more women in the early~     amniotomy group will require cesarean delivery, and the duration of labor will increase in~     the early amniotomy group.~   "
4756|NCT03504657|"~     Posterior circulation stroke accounts for 20% of ischemic stroke. A quarter occurs in~     patients with stenosis in the vertebral and/or basilar arteries. Vertebral artery stenosis~     can be treated with stenting. However, in-stent restenosis rate have been reported as high as~     more than 30%, which may reduce the effect of stent therapy. Drug-coated balloon has shown~     good results in controlling neointimal hyperplasia in the femoral and popliteal arteries.~   "
4757|NCT03504644|"~     This phase Ib/II clinical trial studies the side effects and best dose of venetoclax and how~     well it works when given together with vincristine liposomal in treating patients with T-cell~     or B-cell acute lymphoblastic leukemia that has come back or does not respond to treatment.~     Venetoclax may stop the growth of cancer cells by blocking some of the enzymes needed for~     cell growth. Drugs used in chemotherapy, such as vincristine liposomal, work in different~     ways to stop the growth of cancer cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Giving venetoclax together with vincristine~     liposomal may work better in treating patients with acute lymphoblastic leukemia.~   "
4758|NCT03504631|"~     This study is an observational study to determine phenotype and genotype of CYP2D6 as~     predictors of z-endoxifen concentrations in plasma of outgoing patients treated with~     tamoxifen for at least 4 months~   "
4759|NCT03504618|"~     Colon cancer with metastase in the diagnose time account for one significant rate and has a~     increasing trend. The treatment result of this patient group rests modest. The biological~     therapeutic treatment is still expensive for major part of Vietnamese patients. So that,~     research on a new affordable and efficacious chemotherapy combination for these patients is~     extremely necessary in our country The purpose of the study is to comment somes~     clinico-pathology features of metastatic colon cancer patients whose disease was not~     radically resectable.~      The second aim is to Evaluate the treatment result and toxicity of FOLFOXIRI in these~     patients~   "
4760|NCT03504605|"~     Parents of children with long-term health conditions (LTCs) can experience shame related to~     parenting. Whilst self-compassion interventions (SCIs) can reduce parental shame, this has~     not been studied with parents of children with LTCs. Perfectionistic cognitions may also~     moderate the effects of SCIs. This study will test an online SCI with parents of children~     with type 1 diabetes, epilepsy or asthma. Parents will complete online questionnaires pre-~     and post a SCI/control intervention. Hypotheses will be tested using analysis of covariance~     and moderation analysis. Findings will enhance knowledge of vulnerability factors to distress~     for parents of children with LTCs, and inform interventions.~   "
4761|NCT03504592|"~     This project will utilize MHealth technology to address the barriers providers and obstetric~     patients experience when reporting blood glucose results. Half of the participants will~     record their blood glucose values with the assistance of a smartphone device, the other half~     will continue in the traditional care method of the clinic.~   "
4762|NCT03504579|"~     Auditory hallucinations in schizophrenia are one of the major symptoms of this disease and a~     major source of psychological discomfort. They are often difficult or impossible to treat~     with existing methods. This study will test the use of real-time fMRI neurofeedback to~     mitigate auditory verbal hallucinations in patients whose hallucinations are resistant to~     medication. Half of the patients will receive real time fMRI neurofeedback from a brain~     region involved in auditory hallucinations and half will receive it from motor cortex.~   "
4763|NCT03504566|"~     This project is an intervention study where type 2 diabetic patients will rotate through 4~     different albuminuria lowering drugs with the aim to 1) quantify the individual relationship~     between drug exposure and albumin lowering response of different albuminuria lowering drugs~     in type 1 and type 2 diabetics; and 2) to investigate the effect of the same drug~     intervention on the glycocalyx layer in blood vessels. The overall purpose of this study is~     to allow for future personalized treatment of diabetics with regards to treating kidney~     disease more effectively than current standardized strategies.~   "
4764|NCT03504553|"~     This project will investigate whether reduction in ambient light and elimination of noise on~     induction of anesthesia alters anxiety (modified Yale Preoperative Anxiety Scale or mYPAS) or~     compliance (induction compliance checklist or ICC scoring), alters recovery following~     emergence using pain scores, analgesic requirements, and emergence delirium (post anesthesia~     emergence delirium or PAED), or post-discharge behavior at 1, 7 and 14 days (modified post~     hospitalization behaviour questionnaire or PHBQ) in patients who receive anxiolytic~     premedication. In addition, the investigators will assess the cumulative level of nose~     exposure that patients experience during the perioperative period.~   "
4767|NCT03504514|"~     Ventilation is a major treatment of respiratory failure due to neuromuscular disorders. First~     line treatment is noninvasive ventilation (NIV) but in some situations, especially in case of~     NIV inefficiency, invasive ventilation with tracheostomy (IVT) may be required. In both~     situations, patients may become dependent on ventilatory support with the disease evolution.~     Ventilation then can interfere speech and the quality of communication of the patients.~     Modification of the ventilation parameters may result in improved speech quality (for~     example, positive expiratory pressure (PEP) while not necessary for ventilation quality can~     dramatically improve speech in tracheostomized patients). Therefore, it would be of interest~     to allow patients to benefit from these specific parameters when they need to speak without~     maintaining them when patients are not speaking. We want to evaluate a specific ventilator~     feature which can detect speech and switch to specific ventilation parameters adapted for~     speech We believe that this feature will improve significantly speech quality in patients~     dependant either on NIV or IVT.~   "
4768|NCT03504501|"~     The project is targeting cognitive impairment, one of the main health problems of patients~     with RAS pathway disorders. The aim of this study is to translate findings of animal studies~     to humans. This has been done by the applicants successfully for Lovastatin in Nf1. This~     result will be transferred to patients with Noonan Syndrome. lamotrigine is most likely a~     more effective and promising substance improving synaptic plasticity and consecutive~     cognitive function. It is expected that both substances are improving synaptic plasticity as~     well as alertness and changes in alertness may be a precondition for improvement of~     cognition.~   "
4769|NCT03504488|"~     The objective of this study is to assess safety and efficacy of CAB-ROR2-ADC in solid tumors~   "
4770|NCT03504475|"~     The objective of this study is to compare the rate and extent of absorption of paroxetine~     hydrochloride 20 mg tablets (test) and Paxil® (reference) administered as 20 mg tablet under~     fed conditions.~   "
4771|NCT03504462|"~     Foot surgery is a painful surgery that is usually scheduled in outpatients. A good management~     of analgesia is the crucial point. Regional anesthesia (RA) is the gold standard, that~     provides good anesthesia and a long duration of analgesia. The sciatic nerve block (or its~     branches) is the most adapted analgesic technique.~      Limitation of proximal sciatic block is the motor block of the ankle and results in the~     impossibility, for the patient, to walk during the early post-operative period. Distal block~     of the sciatic nerve (tibial and fibular nerve blocks), at the level of the ankle, has been~     proposed to maintain the mobility of the ankle, to make deambulation with crutches easier.~     Nevertheless, the lack of sensibility of the heel remains a limitation for early walking,~     even with adapted shoes (ie : Barouk).~      A specific anesthesia of the distal part of the foot, respecting the heel, could be the best~     option to provide an early deambulation and a suitable analgesia.~      Ultrasound identification and specific anesthesia of the branches supplying the distal part~     of the foot (medial and lateral plantar nerves) could meet this dual objective : good~     anesthesia and suitable analgesia for early deambulation.~      This study is a feasibility study of a specific block of the plantar branches of the tibial~     nerve, to preserve the sensibility of the heel, in case of foot surgery. The safety of the~     procedure will be assessed according to the rate of postoperative dysesthesia.~   "
4772|NCT03504449|"~     For now, neoadjuvant chemoradiotherapy is routinely performed for T3N1-2M0 rectal cancer.~     However, there are lots of complications following neoadjuvant chemoradiotherapy, such as~     Wound-related complications, anastomotic leakage, anastomotic stenosis, sexual dysfunction,~     testicular or ovary failure. Patients undergoing resection for rectal cancer had low rates of~     local recurrence and long disease-free survival regardless of whether an APR, CAA or low AR~     was performed. The main purpose of preoperative radiotherapy is to lower the local~     recurrence. For the T3N1-2M0 rectal cancer with negative circumferential resection margin~     based on MRI assessment, we suppose might not necessary to receive neoadjuvant~     chemoradiotherapy, for operation can achieve the negative circumferential resection margin.~   "
4773|NCT03504436|"~     This is a prospective, multicenter, single-arm observational study to evaluate the efficacy~     and the morbi-mortality of LEO + in patients with wide neck intracranial aneurysms (fusiform,~     saccular or dissecting), ruptured or not ruptured.~   "
4774|NCT03504423|"~     A prospective, multicenter, open label, randomized phase III study of CPI-613 + mFFX compared~     to FFX in patients with metastatic (Stage IV) adenocarcinoma of the pancreas with age range~     of 18 to 75 years~   "
4775|NCT03504410|"~     A Phase III study to evaluate the safety and efficacy of CPI-613 in combination with High~     Dose Cytarabine and Mitoxantrone in comparison with high dose Cytarabine and Mitoxantrone in~     older patients with relapsed/refractory Acute Myeloid Leukemia. CPI-613 targets the altered~     energy metabolism and processes for production of ATP and essential bio-intermediates unique~     to and characteristic of most cancer cell types. The addition of CPI-613 to high dose~     cytarabine and mitoxantrone (CHAM) will improve the complete remission (CR) rate in patients~     60 years or older with relapsed or refractory AML when compared to HAM alone.~   "
4776|NCT03504397|"~     The purpose of this study is to evaluate the efficacy of IMAB362 plus mFOLFOX6 compared with~     placebo plus mFOLFOX6 (as first-line treatment) as measured by Progression Free Survival~     (PFS) in participants with Claudin (CLDN)18.2 positive, HER2-negative locally advanced~     unresectable or metastatic gastric and GEJ adenocarcinoma.~      This study will also evaluate efficacy, safety and tolerability of IMAB362, as well as its~     effects on quality of life. Pharmacokinetics (PK) of IMAB362 and the immunogenicity profile~     of IMAB362 will be evaluated as well.~   "
4777|NCT03504384|"~     The aim of the work is to provide a validated Arabic version of EuroQol 5D-5L ,so that it~     would be used as a quality of life assessment tool for Egyptian patients~      Specific objectives:~        1. Cross cultural adaptation of the translated Arabic version of EuroQol 5D-5L.~        2. Assessment of the reliability of the translated Arabic version of EuroQol 5D-5L.~        3. Testing the validity of the translated version of EuroQol 5D-5L.~   "
4816|NCT03503864|"~     This clinical trial aims to evaluate the therapeutic effects and toxicity of chemotherapy~     combined with arsenic trioxide treating patients with recurrent or refractory stage 4~     Neuroblastoma.~   "
5007|NCT03501368|"~     The main purpose of this study is to determine the benefit of a drug named ceritinib~     (ZYKADIA) in patients who have progressed on prior melanoma therapy.~   "
4778|NCT03504371|"~     a total of 80 patients age of 36 years old to 65 years old, (ASA) physical status I and II~     undergoing oesophageal procedures.The patients will randomised using concealed envelope~     method into 2 groups, allocation of patients to either group will be done by clinician not~     involved in the study. There are 2 groups of patients: TEA combined with GA (TEA group) or~     bilateral erector spinae block combined with GA (erector group). . In TEA group, patients~     will receive TEA where an epidural catheter will be placed at the T7-8 interspace after~     proper sterilization and positioning of the patient in the sitting position then standard~     technique of application will be applied, then a test dose consists of 3 ml of 1.5%~     preservative free lidocaine with 1:200,000 epinephrine will be injected followed by 5-6 ml of~     bupivacaine 0.25%. Anaesthesia will be standardised In the TEA group, an additional 4-5mL~     epidural doses of bupivacaine 0.25% will be administered at 1 h intervals. In the second~     group, patients will receive bilateral ESP block which will be performed as follows. The~     patient will be placed in a lateral position ultrasound transducer will be placed in a~     longitudinal orientation 3 cm lateral to the T7 spinous process. Three muscles will be~     identified superficial to the hyperechoic transverse process shadow as follows: trapezius,~     rhomboid major, and erector spinae. An 8-cm 22-gauge block needle will be inserted in a~     cephalad-to-caudad direction until the tip lay in the interfascial plane between rhomboid~     major and erector spinae muscles, as evidenced by visualization of local anesthetic spreading~     in a linear pattern between erector spinae and the bony acoustic shadows of the transverse~     processes. A total of 20 mL of 0.25% bupivacaine will be injected then it will be repeated on~     the other side and preformed in the same way without changing the position of the patient to~     achieve sensory block T5-T10 .~   "
4779|NCT03504358|"~     Develop a new scoring system for HCC patients with tumor rupture.~   "
4780|NCT03504345|"~     Recurrent implantation failure (RIF) occurs after women undergo in vitro fertilization and~     have multiple embryos transferred but no resulting pregnancies. RIF is a very challenging~     clinical entity for the reproductive physician and the patient. In fact, there is not even an~     agreed upon definition in the medical community. Many potential causes have been investigated~     over the past several years but no clear answer has emerged. Interest has recently turned to~     the endometrium, or the lining of the uterus. Studies have shown that the genes that are~     turned on in the endometrium vary based on how long this tissue has been exposed to~     progesterone, an important hormone that prepares the uterine lining for implantation of the~     growing embryo. In some women, it seems that they require longer periods of progesterone~     exposure to reach the same state of readiness. We hypothesize that an even larger proportion~     of women in RIF population will require longer treatments with progesterone.~      In this study, we will randomize women with RIF who are about to undergo a frozen embryo~     transfer to one of two groups. The first group will have their embryo transfer done on the~     standard sixth day of progesterone treatment. The other group will have their transfer done~     on the seventh day of progesterone. We will be comparing the clinical pregnancy rate of the~     two groups as well as the live birth rate and miscarriage rate. We expect that extending the~     progesterone treatment by one day will increase the pregnancy rate of women with RIF.~   "
4781|NCT03504332|"~     The object of this study is to compare the effect of Calcium Hydroxide and Di-antibiotic~     paste as intracanal disinfectants in the 1st visit of revascularization of necrotic immature~     permanent anterior teeth.~   "
4782|NCT03504319|"~     Maternal obesity during pregnancy is a serious public health concern as it contributes to~     inflammation, insulin resistance, and excessive gestational weight gain- all of which~     negatively impact maternal and neonatal health. Fortunately, physical activity during~     pregnancy improves obstetric and infant outcomes associated with obesity. Specifically, data~     from our group demonstrated that irrespective of body weight, women who were~     physically-active during pregnancy had lower levels of systemic inflammation; however, the~     mechanism/s driving these changes are poorly understood. Previous studies in non-gravid~     populations suggest obesity-associated overnutrition may contribute to inflammation and this~     subsequent inflammation may lead to further metabolic dysfunction- perpetuating a vicious~     cycle. However, the connections between physical activity, inflammation, and metabolic~     dysfunction (i.e. metabolic inflexibility), particularly in response to a high-fat meal~     (similar to that which is typically consumed in a Western diet), among lean and obese~     pregnant women have not been studied. Thus, this study will examine the impact of a~     physically-active lifestyle on inflammatory and metabolic responses to a high-fat meal in~     lean and obese pregnant women. Understanding mechanisms connecting maternal physical activity~     to improved outcomes will better inform future targeted intervention strategies. The goal of~     this study is to determine the role of a physically-active lifestyle during pregnancy on~     metabolic function and inflammation following a high-fat meal in lean and obese pregnant~     women.~   "
4783|NCT03504306|"~     This study aims to validate the use of the Ventriject product to estimate VO2 max, through a~     non-physically active test using ECG, echoseismography and echosonography.~   "
4784|NCT03504293|"~     ERCP with brush cytology has a poor to moderate accuracy in unclear biliary lesions.~     Endoscopic ultrasound (EUS) with fine needle aspiration (FNA) for cytology may override some~     of these shortcomings.~      The current prospective study, performed in a tertiary University center, aims to study the~     feasibility, the accuracy and the clinical value of combinatory ERCP and EUS in unclear~     biliary lesions.~   "
4785|NCT03504280|"~     it is a clinical trial to observe increase in serum vitamin D level and clinical symptoms~     after 3 different doses of cholecalciferol given either intramuscularly or oral.~   "
4786|NCT03504267|"~     Despite the well-established benefits of physical activity, only 23% of pregnant women report~     exercising in accordance with guidelines recommended by the American Congress of~     Obstetricians and Gynecologists. Further, pregnant women report receiving little or no advice~     about physical activity during pregnancy from their health care provider; thus, the~     scientific evidence supporting physical activity during pregnancy does not appear to be~     translating into the clinic and the community. The goal of this project is to determine if~     the distribution of evidence-based educational materials and local resources will increase~     knowledge regarding the benefits of physical activity during pregnancy, patient-provider~     communication about physical activity during pregnancy, and physical activity levels during~     pregnancy.~      Hypothesis A: Pregnant women who receive evidence-based educational materials and local~     resources will have increased knowledge regarding the benefits of physical activity during~     pregnancy.~      Hypothesis B: Pregnant women who receive evidence-based educational materials and local~     resources will have more communication with their health care provider about physical~     activity.~      Hypothesis C: Pregnant women who receive educational information and local resources will~     report increased physical activity levels.~      Hypothesis D: Pregnant women who receive evidence-based educational materials and local~     resources will have improved pregnancy outcomes including lower gestational weight gain,~     lower insulin resistance (as determined by their clinical oral glucose tolerance test), and~     healthier neonatal birthweight.~   "
4787|NCT03504254|"~     Cervical myelopathy (CM), a chronically compressive spinal cord lesion, is the most common~     cause of non-traumatic paraparesis/quadriparesis among the elderly. Hong Kong is facing a~     heavy social economic burden from CM with the rapidly aging population. Surgical~     decompression is considered as the mainstay of the treatment for CM patients to relieve their~     symptoms and signs. Yet the surgical outcome is not always satisfactory. There is a pressing~     need for understanding the exact mechanism of surgical decompression on the recovery of~     myelopathic cord in order to improve the prognosis of CM patients in near future.This project~     will evaluate neuronal activities and axon regeneration by longitudinally monitoring at time~     zero, 3 and 6 month after the surgery in CM patients using UTE, BOLD-fMRI and DTI, and to~     investigate the relationship of preoperative neuronal activities of myelopathic cord with~     axon regeneration.~   "
4788|NCT03504241|"~     Anti-rejection medicines, also known as immunosuppressive drugs, are prescribed to organ~     transplant recipients to prevent rejection of the new organ. Long-term use of these medicines~     places transplant recipients at higher risk of serious infections and certain types of~     cancer.~      The purpose of this study is to determine if:~        -  it is safe to give mesenchymal stromal cells (MSCs) to kidney transplant recipients, and~        -  the combination of the immunosuppressive (anti-rejection) study drugs plus the MSCs can~          allow a kidney transplant recipient to slowly reduce and/or then completely stop all~          anti-rejection drugs, without rejection of their kidney (renal) allograft, a process~          called immunosuppression withdrawal.~   "
4789|NCT03504228|"~     Approximately 2000 patients eligible for elective treatment with a Carotid Stent according to~     hospital routine practice in centers across Europe will be enrolled in the study. The maximum~     number of patients enrolled at each site will be not limited. Follow-ups are scheduled at~     discharge, 30 days, and 1 year, as per local practice. Each patient will have follow-up~     contacts via hospital visit and/or telephone.~   "
4790|NCT03504215|"~     In spite of advances in neonatal intensive care allowing the first generation survivors of~     extreme prematurity to now reach young adulthood, these individuals present with reduced~     exercise capacity; a strong predictor of later chronic disease and mortality. The reason why~     individuals born preterm have exercise limitation remains unclear and may be a consequence of~     impact of preterm birth and associated neonatal difficulties on the development of organs~     important for exercise, namely the lungs, the heart, the vessels (which bring blood and~     oxygen to the muscles) and the muscles. It is well known that exercise benefits overall~     health in at-risk as well diseased populations. However, whether exercise training can~     improve fitness in young adults born preterm was not demonstrated and whether the~     cardiovascular, pulmonary and muscle impairments associated with preterm birth are reversible~     through exercise intervention in young adulthood is unknown.~   "
4791|NCT03504202|"~     This is a prospective study which aims to explore the effect of Trimetazidine on the~     improvement of coronary microvascular dysfunction in patients with INOCA (ischemia and no~     obstructive coronary artery disease). Enrolled patients will be assessed SAQ(Seattle Angina~     Score), Canadian Angina Grade(Canadian Cardiovascular Society, CCS), Six-Minute Walk Test,~     CFR(coronary flow reserve) .CFR inspection with D-SPECT and pressure guide wire.Patients will~     receive six months Trimetazidine(20mg tid) after enrollment. And their SAQ (Seattle Angina~     Score), Canadian Angina Grade(Canadian Cardiovascular Society, CCS), Six-Minute Walk Test,~     CFR will be followed up.~   "
4792|NCT03504189|"~     This clinical study will evaluate the safety of PregSense™ and Comparative Performance of~     PregSense™ versus CTG in Prenatal Monitoring of Pregnant subjects.~   "
4793|NCT03504176|"~     Mortality rates in children with pediatric acute respiratory distress syndrome (PARDS) are~     higher in Asia compared to other regions. In adults with acute respiratory distress syndrome,~     the only therapy that improves mortality rates is a lung protective ventilation strategy. The~     pediatric ventilation recommendations by the Pediatric Acute Lung Injury Consensus Conference~     (PALICC) are extrapolated from evidence in adults, including ventilation with low tidal~     volume, low peak/plateau pressures and high end expiratory pressure. A recent retrospective~     study of ventilation practices in Asia including Singapore showed that a majority of patients~     with PARDS were being ventilated with high tidal volume, high peak pressure and low end~     expiratory pressure, not in compliance with PALICC recommendations. We postulate that~     currently used ventilation strategies could have contributed to the high PARDS mortality~     rates in Asia. We aim to determine if implementing a ventilation bundle comprising PALICC~     recommendations lowers PARDS and pediatric intensive care unit (PICU) mortality rates.~   "
4794|NCT03504163|"~     The purpose of this study is to find out what effects, good and/or bad, pembrolizumab has on~     the participant and urothelial cancer.~   "
4795|NCT03504150|"~     This randomized controlled trial will compare the effectiveness of two online self-guided~     programs for youth and young adults with migraine against usual care.~   "
4796|NCT03504137|"~     The investigators are interested in whether or not the use of a mobile health (mHealth)~     application increases the rate of immunosuppression medication adherence among adolescent~     kidney transplant recipients. The investigators aim to test this by recruiting adolescent~     (ages 14-21) kidney transplant recipients to use an mHealth application to record themselves~     taking their immunosuppression medications, and tracking medication adherence over time. The~     study population will be approximately 50 adolescent kidney transplant recipients at the~     Johns Hopkins Hospital.~   "
4797|NCT03504124|"~     The investigators propose to assess the needs, barriers, and knowledge gaps of hypertension~     control programs in the national health care systems of the Central America 4 region LMIC~     (CA-4: Guatemala, Honduras, El Salvador, and Nicaragua); to conduct a cluster randomized~     trial to test the effect of a multilevel and multicomponent intervention program leveraging~     an existing subnational primary healthcare system in Guatemala, on blood pressure (BP)~     control among hypertensive patients; and to evaluate the adaptability, feasibility, fidelity,~     and sustainability of implementing the program in the primary health care systems of the CA-4~     region. The comprehensive intervention, which includes protocol-based treatment using a~     standard BP management algorithm, team-based collaborative care, BP audit and feedback, home~     BP monitoring, and health coaching on antihypertensive medication adherence and lifestyle~     modification, will last for 18 months. This implementation research study presents high~     public health impact because it will generate urgently needed data on effective, practical,~     and sustainable intervention strategies aimed at reducing BP related disease burden in~     Central America and other low- and middle-income countries.~   "
4798|NCT03504111|"~     Chronic tendinopathy is often very difficult to treat and causes many patients who suffer~     from it to have significant pain and loss of function leading to disability. Ultrasound has~     been shown to be very effective in aiding in the diagnosis of soft tissue disorders including~     tendinopathy and can help to rule in or out other potential causes that may be confounders.~     Numerous methods have been tried to treat tendinopathy including rest, NSAIDs, bracing,~     physical therapy, extracorporal shock wave therapy, anesthetic injections, steroid~     injections, prolotherapy, nitro patches, surgery and more recently platelet rich plasma, all~     of which have had conflicting results in the literature. Platelet rich plasma (PRP) is an~     autologous blood product that contains a high concentration of platelet-derived growth~     factors that have the potential to enhance healing. In a study by Mishra et al, common~     extensor tenindosis showed improved pain symptoms (71% vs 55% at 24 weeks) with tenontomy~     combined with PRP compared to percutaneous needle tenontomy alone. Current studies show~     conflicting results as to whether PRP improves chronic tendinopathy when compared to steroid~     injections, and many do not have any control group or comparison group. Percutaneous needle~     tenotomy is the use of a large gauge needle (18 gauge), which may be performed under~     ultrasound guidance, to fenestrate repeatedly the area of tendinopathy within a tendon in~     order to disrupt tendinopathic tissue and to induce bleeding and clot formation with release~     of growth factors. To date there are no published studies comparing percutaneous needle~     tenotomy (PNT) alone vs. PRP without concomitant tenotomy. Current literature suggests that~     needle tenotomy may be superior but no head to head studies are currently found in the~     literature. Most of the published literature of non-operative treatment of tendinosis does~     not yield clearly designed trials with clear selection criteria. Current literature also~     lacks studies with significant number of patients that meet both clinical and ultrasound~     criteria thus previous studies lack sufficient power. The PRINT TRIAL: may enhance the~     understanding of a superior treatment if it exists.~      Hypothesis: In active adults with chronic tendinopathy who have failed to respond to standard~     of care treatment, the use of ultrasound guided percutaneous needle tenotomy (PNT) alone is~     superior to PRP without concomitant tenotomy.~   "
4799|NCT03504098|"~     Non-small cell lung cancer (NSCLC) accounts for more than two-thirds of lung cancer, which is~     the leading cause of cancer deaths in Taiwan. The overall prognosis of NSCLC is poor with low~     5-year survival rates. Recent advances suggest that malignancy NSCLC cancers are the cancer~     stem cell (CSC) diseases. The stemness potentials of CSC with epithelial-mesenchymal~     transdifferentiation ensure their invasion and disseminate to metastsis organs. The~     self-renewal property of CSC mediates intrinsic drug resistance to cytotoxicity therapy and~     promoted aggressive relapse tumour. Metabolic reprogramming on bioenergetics of malignant~     cancer cells has been proposed as the key mediator in the stemness CSC development.~     Malignancy cells uptake glucose for fermented glycolysis to produce lactate which release~     resulted in acidified microenvironment to trigger the mTOR and sonic hedgehog metabolic~     stress signaling in supporting CSC stemness potentials. The metabostemness of cancer cells is~     the new-dimensional hallmark of malignancy tumour, which may serve as the diagnostic markers~     for the early detection of malignancy cancers. Folate-mediated one carbon metabolism~     coordinates glucose into amino acid metabolism to tailor the fuel metabolites in supporting~     macromolecule synthesis and to sustain the bioenergetics requirement. Acting as the metabolic~     stressor, low folate intake is associated with increased risks of lung cancers. Folate and~     one-carbon nutrient status of NSCLC patients in Taiwan, however, has not been assessed. The~     role of low folate metabolic stress (LFMS) in metabostemness marker and metastasis potentials~     of malignancy NSCLC is unexplored. The causal effect and the working mechanisms by which LFMS~     promoted NSCLC malignancy remain elusive.~   "
4800|NCT03504085|"~     Our primary aim is to assess the feasibility of conducting yoga research among active-duty~     military personnel with Chronic Low Back Pain (CLBP) and/or Chronic Neck Pain (CNP). In~     addition, we will evaluate the yoga intervention preferences and refine an existing yoga~     intervention to address those needs. The study will prepare us for a R01 funded pragmatic~     clinical trial of yoga for CLBP and CNP in active-duty military.~   "
4801|NCT03504072|"~     Treatment failure of Spondyloarthropathies (SpA) leads to marked functional disability,~     higher rates of morbidity, mortality and poor quality of life. In TB endemic countries~     effective and safe drugs are to be in hand to manage this group of patients. The aim of this~     study will be to evaluation the risk of tuberculosis and other infections in refractory SpA~     patients treated with tofacitinib. After having consent 174 adults will be enrolled. Follow~     up period will be 9 months (visits 0, 1, 3, 6 and 9). Study subjects (87) will receive~     tofacitinib (5 mg 12 hourly). Control patients will get etanercept (50 mg subcutaneously~     every 7 days interval for 1st month then 50 mg in 15 days interval for 2nd month then 50 mg~     every 21 days interval till final visit.~      Treatment efficacy assessment tool will be BASDAI, ASDAS-ESR, ASDAS-CRP and ASQoL for quality~     of life. Occurrences of tuberculosis and serious infection will be the primary end point of~     this study. The quantitative variables like ESR, CRP, BASDAI, ASDAS-ESR, ASDAS-CRP and ASQoL~     scores will be computed as mean and SD. Occurrences of TB and infection will be expressed in~     number and percentage. In between groups according to data distribution, students't test or~     ManWhitny U test will be done. The P value <0.05 will be considered significant. Each patient~     will enjoy every right to participate or refuse or even withdraw from the study at any point~     of time. Anonymity and data confidentiality will be maintained strictly. Ethical clearance~     will be obtained from Institutional Review Board (IRB) of BSMMU.~      The expected utility of this study will be; a) reporting on occurrence of TB and other~     infections in SpA patients with tofacitinib and etanercept, b) if identified safe and~     effective physician can use the agents without fear, c) for dose spacing of etanercept the~     cumulative dose will be low might make the drug affordable and also reduce the risk of TB and~     other infections, d) for spaced follow up schedule there will be minimized physician visit,~     lab testing etc.~   "
4802|NCT03504059|"~     Background and objective:~      There is an alarming increase in obesity and unhealthy lifestyles in adolescents. This issue~     threatens to have a highly negative health and socioeconomic impact in the near future. The~     only way to tackle this epidemic is to implement effective preventive strategies able to~     positively impact on youth lifestyle behaviours. The school is the most appropriate~     environment for such an intervention. The main objective of this study is to evaluate the~     efficacy of a comprehensive educational school-based intervention in adolescents on~     cardiovascular health, including obesity/adiposity and metabolic profiles. The project~     consortium constitutes a unique framework of research groups at the forefront of novel and~     successful approaches aiming to healthier behaviours and dietary habits.~      Methodology:~      A cluster-randomized controlled trial involving 24 secondary schools in Spain will be carried~     out. Schools will be 1:1:1 randomized to receive a short-term (2-year) or a long-term~     (4-year) comprehensive educational program, or to receive the usual curriculum (control).~     Participants will be evaluated at baseline, and after 2 and 4 years with the following:~     weight scale, circumference measuring tape, bioelectrical impedance, dual energy X-ray~     absorptiometry, sphygmomanometer, blood analysis, saliva and urine analysis, accelerometers,~     and questionnaires. The primary outcome is the change in obesity and other health parameters~     from baseline to year 2 and 4, as assessed by the Ideal Cardiovascular Health score.~     Secondary outcomes include the change in adiposity, anthropometry and body composition~     parameters, physical activity and dietary habits, polyphenol and carotenoid intake,~     metabolomics and attitudes. Participants will be measured again when they reach 20 years old.~      Expected results:~      The investigators expects to show that a school-based educational intervention induces~     favourable lifestyle changes and improves cardiovascular health among Spanish adolescents,~     including obesity/adiposity and metabolic profiles. If successful, this strategy could be~     widely adopted having a meaningful effect on obesity and cardiovascular health promotion.~     Additionally, associations of health parameters with bioactive dietary compounds intake and~     metabolic profiles will be stablished.~   "
4803|NCT03504046|"~     This clinical trial is a safety and feasibility study to assess the performance of artificial~     pancreas (AP) system using the Zone Model Predictive control (Zone-MPC) and Health Monitoring~     System (HMS) algorithms embedded into the APS APP platform.~   "
4804|NCT03504033|"~     The aim of this study is to compare the postoperative outcome of patients undergoing major~     liver resection under xenon- compared to desflurane-anesthesia.~   "
13101|NCT03395353|"~     The purpose of this long-term study is to evaluate the safety and efficacy of duloxetine~     hydrochloride in Japanese children and adolescents with depressive disorder.~   "
4805|NCT03504007|"~     The Gonda Vascular Center- Thrombophilia Clinic at Mayo Clinic in Rochester, Minnesota~     utilizes a standardized, guideline-directed, yet patient-oriented approach for treating~     patients diagnosed with venous thrombo embolism (VTE).~      The rates of VTE recurrence, major bleeding, clinically relevant non-major bleeding (CRNMB)~     and survival in patients treated with anticoagulation for acute VTE are assessed during~     prospective observation. VTE cases include an acute deep vein thrombosis (DVT) of lower or~     upper extremities, splanchnic veins, gonadal, renal, cerebral veins thrombosis and pulmonary~     embolism (PE). Therapy includes the whole spectrum of FDA approved anticoagulants such as~     classic agents: warfarin and heparinoids and the newer direct oral anticoagulants (DOACs)~     such as rivaroxaban, dabigatran, apixaban, and edoxaban.~   "
4806|NCT03503994|"~     While many short-term morbidities associated with extreme prematurity have declined over the~     last two decades, the incidence of bronchopulmonary dysplasia (BPD) has increased to a rate~     of approximately 45% in neonates <28 weeks gestational age (GA) and birth weight (BW) <1,500~     g. Neonates with BPD are at increased risk for adverse short-and long-term neurodevelopmental~     and respiratory outcomes that often persist into adulthood.~      There is a growing body of pathological and biochemical evidence that implicates inflammation~     in its pathogenesis. This is further supported by randomized controlled trials (RCTs) that~     demonstrate the efficacy of systemic corticosteroids in facilitating extubation and reducing~     BPD. However, several short- and long-term adverse effects associated with the use of~     systemic corticosteroids have been described, the most concerning of which is their effect on~     neurodevelopment, specifically an increased rate of cerebral palsy (CP).~      Inhaled corticosteroids (ICS) are an attractive alternative to systemic steroids because of~     these concerns. Earlier systematic reviews had not found any benefit in using ICS for the~     prevention or treatment of BPD. However, a recent systematic review showed a significant~     reduction in death or BPD at 36 weeks' corrected GA (CGA) (risk ratio=0.86, 95% confidence~     interval 0.75, 0.99), BPD (RR=0.77, 95% CI 0.65, 0.91), and use of systemic steroids~     (RR=0.87, 95% CI 0.76, 0.98) in infants treated with ICS.~      Despite growing evidence of the effectiveness of ICS for BPD, uncertainty remains over~     treatment timing, effective dose, and long-term effects. There is also variation in the~     delivery systems used for delivery of ICS. These concerns continue to be echoed in a recent~     review by Nelin et al. Given that the long-term neurodevelopmental impact of ICS were unknown~     at the time of this study and many infants are able to wean from ventilation without~     steroids, the investigators conducted an escalating-dose ranging study of late ICS (i.e.~     administered after the first week of life) delivered by a metered dose inhaler (MDI)~     utilizing a specially designed valved delivery system to determine the minimum effective dose~     necessary to achieve extubation or reduction in oxygen requirements and the long-term~     neurodevelopmental impact of increasing doses of ICS.~   "
4807|NCT03503981|"~     This research project seeks to acquire a deeper understanding of the complex influences of~     common factors and specific ingredients in psychotherapy. By using frequent process-outcome~     measures, it will address individualized mechanisms of change in psychotherapy by assessing~     both between and within patient change processes, using a wide spectrum of change indicators.~   "
4808|NCT03503968|"~     This is a multicentre, non-randomized, open-label, Phase I/II clinical trial of MDG1011, an~     investigational medicinal product (IMP), consisting of patient-derived autologous T cells,~     persistently transduced with a Preferentially Expressed Antigen in Melanoma (PRAME)-specific~     human leukocyte antigen (HLA)-A*02:01-restricted T cell receptor (TCR).~   "
4809|NCT03503955|"~     With Leap Motion Controller, virtual reality exercises have been implemented more often since~     2014, and this technology has benefited more from upper extremity rehabilitation In~     literature, there are no publications investigating the effectiveness of virtual reality~     applications on upper extremity functions in cases of mental retardation with Leap Motion.~      We think that virtual reality applications with Leap Motion are effective in fine motor~     skills and grip strength in cases of mental retardation.~      The purpose of our work; To Investigation of the Effectiveness of Video Based Games on Upper~     Extremity Functions in Mild Mental Retardation Diagnosed Cases~   "
4810|NCT03503942|"~     The Pre-DICTED (Pre-Diabetes Intervention and Continued Tracking to Ease-out Diabetes)~     program is a community-based diabetes prevention program. This study aims to test the~     effectiveness of structured, group-based lifestyle interventions with stepwise addition of~     metformin, if required, among subjects with pre-diabetes in multi-ethnic Singapore.~   "
4811|NCT03503929|"~     LaparoGuard is intended as an adjunctive safety system for laparoscopic surgery. The system~     allows surgeons to virtually annotate a safe anatomical volume inside the body cavity of the~     patient during a laparoscopic surgery. The surgeon then receives notification throughout the~     procedure whenever a tracked rigid instrument has exited that volume. This open label,~     prospective, feasibility, single site, multi-investigator trial will evaluate the feasibility~     and usability of the LaparoGuard system during laparoscopic surgical procedures.~   "
4812|NCT03503916|"~     Falls are one of the most common reasons for immobilisation and death in elderly population.~     This study aims at studying falls among a group of older people. The aim is to study the~     relation between movement patterns, balance performance, inner ear function and future falls.~     Senior member will be recruited through the non-profit association Friskis&Svettis. Measures~     of movement patterns, balance performance and innear ear function will be measured at~     baseline. Falls will be monitored through falls diaries, collected every third month during a~     12 month period.~   "
4813|NCT03503903|"~     This study evaluates the efficacy of Wet cupping Therapy on oxidative stress and antioxidant~     capacity of the body.The healthy volunteers will receive wet cupping application and their~     initial venous blood samples and samples after the treatment will be evaluated for oxidative~     stress.~   "
4814|NCT03503890|"~     This is an expanded access program (EAP) for eligible participants. This program is designed~     to provide access to Rovalpituzumab Tesirine prior to approval by the local regulatory~     agency. Availability will depend on territory eligibility. Participating sites will be added~     as they apply for and are approved for the EAP. A medical doctor must decide whether the~     potential benefit outweighs the risk of receiving an investigational therapy based on the~     individual patient's medical history and program eligibility criteria.~   "
4815|NCT03503877|"~     Embryonic aneuploidy is the underlying etiology for the majority of failed implantation and~     miscarriage. Preimplantation genetic screening (PGS) with transfer of a euploid embryo has~     been advocated as a strategy for increasing live birth rates with a single embryo transfer.~     Culturing embryos to the blastocyst stage for trophectoderm biopsy is a requirement for PGS.~     Several commercially-available single-step embryonic culture media with varying composition~     have been established for use in the IVF laboratory. Early reports have suggested differences~     in clinical outcomes, such as aneuploidy and miscarriage rates, with distinct culture media~     currently in standard use.1,2 However, there have been no clinical trials demonstrating the~     superiority of any one commercially-available culture media formulation. As a result, clinics~     use media with varying composition based upon familiarity and cost.~   "
4818|NCT03503838|"~     Polycythemia vera (PV), essential thrombocytosis (ET), and myelofibrosis (MF) are chronic~     Philadelphia negative myeloproliferative neoplasms (MPNs) that are characterized by clonal~     proliferation of hematopoietic stem cells, intramedullary fibrosis, and splenomegaly. While~     disease manifestations may vary amongst the spectrum of MPNs, quality of life considerations~     including fatigue, concentration difficulties, pain, sleep disturbance, and depression are~     negatively affected in most MPN patients. Inflammation has been suggested to be involved in~     the development of disease-related symptoms. Specific pro-inflammatory cytokines (e.g., IL-1,~     IL-6, IL-8, and TNF-α) have been associated with particular patient-reported symptoms,~     including fatigue, abdominal complaints, microvascular symptoms, and constitutional symptoms.~     Pharmacologic therapy can positively impact MPN related symptoms, specifically with JAK~     inhibition, however, these treatments often come with negative side effects (e.g., anemia,~     thrombocytopenia). Much opportunity remains for improving MPN symptoms (i.e., fatigue,~     insomnia, loss of muscle mass, and debilitation) and quality of life.~      Yoga, a gentle form of meditative exercise, has been shown to improve symptom management and~     quality of life parameters in cancer patients and may be effective in improving MPN-related~     symptoms. Here we propose a study evaluating the efficacy of an online yoga intervention~     comparing a yoga group to a wait-list control group for improving symptom burden and quality~     of life in MPN patients. Secondarily, we plan to evaluate the feasibility of collecting~     potential biomarkers that are related to MPN disease-related activity, such as fatigue (i.e.,~     cortisol and serum cytokines).~   "
4819|NCT03503825|"~     The main purpose of this study is to test the safety and tolerability of T-087. The study~     will enroll 6 healthy volunteers (HVs) and 6-18 subjects with KOA. All eligible subjects will~     receive an intravenous injection of the radioactive investigational product (T-087), followed~     by SPECT/CT imaging of the knees and blood tests and clinical assessments for safety~     monitoring. Healthy volunteers will also have their whole body imaged and have extra blood~     drawn to determine where T-087 goes in the body. These additional procedures will be done on~     the same day as the ip administration, and repeated the following day. All subjects will have~     a final follow-up phone call within 2- 3 business days following the ip administration.~   "
4820|NCT03503812|"~     The MEDEA project is envisioned to provide the field-based evidence for the adoption of a~     strategic plan for mitigating the health effects of desert dust storm (DDS) events in~     South-Eastern Europe. Over the past decade, several studies have demonstrated that DDS in~     Mediterranean countries, originating mostly from the Sahara and Arabian Peninsula deserts,~     have been increasing in number and magnitude and linked it to desertification, climatic~     variability and global warming. EU legislation considers DDS impossible to prevent,~     implicitly harmless and discounts their contribution to daily and annual air quality~     standards of particulate matter up to 10 microns (PM10). However, there is increasing~     evidence from epidemiological studies, which correlates exposure to PM10 during DDS with a~     significant increase in mortality and hospital admissions from cardiovascular and respiratory~     causes. Therefore, there is a pressing need for EU policies to reduce population exposures~     and increase individual, population and institutional resilience to the growing frequency and~     intensity of DDS. MEDEA ultimate goal is to demonstrate the feasibility and effectiveness of~     an adaptation strategy to DDS and better inform EU policy making. The adaptation strategy~     will be carried out within two panel studies, with two different groups of patients; 1.~     Children with asthma and 2. Adults with atrial fibrillation (AF). The primary objective will~     be to quantify the vulnerability of children with asthma and adults with AF during DDS~     outbreaks and provide evidence-based estimates demonstrating which~     interventions/recommendations work best in mitigating adverse health effects in this group of~     patients after randomization of each group of patients to three parallel intervention groups:~     a) No intervention for DDS; b) Intervention for outdoor exposure reduction, and c)~     Interventions for both outdoor and indoor exposure reduction. The secondary objective of the~     study is to demonstrate which of the recommendations are effective in reducing outdoor and~     indoor exposures to DDS in a panel of children with asthma and in a panel of AF adults.~      Intervention: Each group of patients (children with asthma and AF patients) will be recruited~     and will be randomized during the high DDS outbreaks season (Spring 2019 and 2020) with 1:1:1~     ratio into three parallel groups to receive: a) No intervention for DDS; b) Intervention for~     outdoor exposure reduction, by reducing the time spend outdoors and by avoiding physical~     activity and c) Interventions for outdoor (as above) and indoor exposure reduction (by~     minimizing home ventilation and filtering indoor air). Disease-related adverse health~     outcomes will be assessed in the three parallel arms of the study.~      Approaches for delivering the intervention: A bidirectional, patient-centered e-Platform will~     be developed in order to facilitate prompt communication with the participants and provide~     early warnings regarding forecasted upcoming DDS events through text messaging and smartphone~     applications. Furthermore, the same IT platform and mobile application will be utilised for~     the dissemination of the exposure reduction guidelines that the participants will follow.~      Assessment of adherence to intervention: 1.Monitor compliance to exposure-reduction~     guidelines using remote sensors. The intervention for outdoor exposure reduction, entailing~     reduction of the time spend outdoors and avoidance of physical activity, will be assessed~     with the use of smart wristwatches that will be equipped with Global Positioning System (GPS)~     and an accelerometer. 2.The intervention for indoor exposure reduction, entailing~     minimization of home ventilation and filtering of indoor air, will be assessed with the use~     of particle samplers that will be placed outside and inside of houses and school classrooms.~   "
4821|NCT03503799|"~     Systematic assessment of survival data of patients who have been tested with EndoPredict®;~     prospective proof that patients with low risk classification by EndoPredict® (EPclin) can~     safely forgo chemotherapy and be treated with endocrine therapy alone.~   "
4822|NCT03503786|"~     This study aims to evaluate the safety and activity of the Avelumab in combination with~     Carboplatin-Paclitaxel in advanced or recurrent endometrial cancer~   "
4823|NCT03503773|"~     To obtain an assessment of the efficacy and safety of renal denervation by alcohol-mediated~     neurolysis using the Peregrine Kit in hypertensive subjects in the absence of~     antihypertensive medications.~   "
4824|NCT03503760|"~     This is a randomized double-blind crossover study. The investigators applied ELF with a~     device named LIMFA Therapy® to 48 fibromyalgic patients, assigned in two groups (true-sham~     and sham-true). Fibromyalgia severity was assessed with the Fibromyalgia Impact Questionnaire~     (FIQ), quality of sleep with the Pittsburgh Sleep Quality Index (PSQI) questionnaire and~     global quality of life with Short Form-12 of Physical and Mental Health Summary (SF-12)~     questionnaire.~   "
4825|NCT03503747|"~     The objective of this study is to determine the percentage of children with genetic markers~     putting them at increased risk of developing type 1 diabetes, and to offer the opportunity~     for these children to be enrolled into a phase II b primary prevention trial.~   "
4826|NCT03503734|"~     Chronic headache is among the most common neurological disorders with major physical,~     psychological, social and economic impact. The aim of this prospective observational study~     isto investigate the effects of an interdisciplinary multimodal integrated care program in~     patients with chronic migraine and/or tension-type headache.~      158 patients with chronic migraine or tensions-type headache at least five days per month for~     at least 6 months and current intake of triptans (migraine) or analgesic drugs (tension-type~     headache) are eligible. Patients undergo inpatient, outpatient and/or semi-stationary~     treatment including conventional headache diagnostics and therapy as well as traditional~     Chinese medicine, European naturopathy, and mind-body-medicine approaches. Headache frequency~     is defined as the primary outcome; secondary outcomes include pain (visual analog scale, Pain~     Perception Scale), triptans and analgesics use (headache diary), health-related quality of~     life (SF-36), function (Headache Disability Inventory, Patient-specific Functional Scale),~     depression and anxiety (Hospital Anxiety and Depression Scale), and pain self-efficacy (Pain~     Self-Efficacy Questionnaire). Outcomes are assessed at treatment start, treatment end and 6~     months after treatment end.~   "
4827|NCT03503721|"~     The aim of this study is to compare two different surgical methods for treating benign~     prostatic obstruction (BPO).~      The investigators are going to compare the risks and benefits of bipolar transurethral~     resection of the prostate (TURP) and bipolar transurethral enucleation of the prostate~     (BipolEP). Furthermore, the investigators are going to compare the amount of tissue resected~     per minute, in order to assess the efficiency of each surgical method.~      It is a prospective, interventional, multi-centre (2 centres total), randomized trial.~      Approximately 84 patients will be included~   "
4828|NCT03503708|"~     Alcoholic liver disease represents the major health issues and it ranges from simple~     steatosis to cirrhosis. There is a paucity of data to support the allopathic intervention~     among these group of patients. Livitol-17 consist of the 3 whole herbs and extract which has~     antioxidant, hepatoprotective as well as reno-protective properties. The aim of this trial is~     to study the efficacy of herbal supplement to improve the liver function of alcoholic liver~     disease subject.~   "
4841|NCT03503539|"~     The investigators aimed to evaluate whether these parameters could be guides for us in the~     selection of RIRS or Mini-PNL procedures in kidney stones that are smaller than 2 cm.~      The patients that have kidney stones smaller than two cm and be planned to undergo surgery~     were randomized into 2 groups prospectively. RIRS was performed in the RIRS group using a~     7.5-F fiberoptic flexible ureterorenoscope while Mini-PCNL group was dilated up to 16.5F and~     mini-PCNL was performed with 12F nephroscopy. Preoperative characteristics, operative and~     postoperative results were compared in two groups. Thereafter, intra and intergroup~     comparisons were made to determine the effects of HU value, indicating the stone density,~     higher or less than 677 and the stone location on stone-free rates.~   "
4829|NCT03503695|"~     Background: In the U.S. approximately 1.6 million adults use complementary and alternative or~     integrative medicine therapy for pain and insomnia. However, very few studies have tested the~     use of auricular acupuncture (AA) using a standard protocol for participants with chronic~     pain and insomnia.~      Objective: To assess the feasibility and acceptability of AA and to evaluate the~     effectiveness of AA on pain severity score, pain interference score, and insomnia over an~     8-day study period.~      Subjects: 45 participants who met the eligibility criteria and signed the consent were~     randomized to either the AA group (AAG) or the usual care control group (CG) on day 4.~      Intervention: A standard AA protocol using penetrating semi-permanent acupuncture needles and~     in-place for up to four days.~      Main Outcome Measures: Brief Pain Inventory pain severity and interference scores for pain~     and Insomnia Severity Index (ISI) for insomnia.~      Results: The use of the standard AA protocol in the AAG led to significant within- and~     between-group reduction in pain severity and interference scores when compared to the CG.~     Both groups showed within-group decrease in ISI. However, the AAG showed significant~     between-group reduction in ISI severity and from moderate to sub-threshold insomnia.~      Conclusions: AA was found to show effectiveness in the treatment of chronic pain and~     insomnia. With a heightened focus on the opioid crisis in the U.S., this easy-to-administer~     protocol can be an option for treatment modality for military beneficiaries with chronic pain~     and insomnia.~   "
4830|NCT03503682|"~     Aim of the study is to assess efficacy of a short course radiation treatment in patients with~     complicated bone metastases~   "
4831|NCT03503669|"~     The purpose of this pilot study will be to test whether Kundalini yoga (KY) and Kirtan Kriya~     (KK) yogic meditation is superior to Memory Enhancement Training (MET) for improving~     cognitive functioning, health (including cardiovascular factors), and mood in women with high~     AD risk.~   "
4832|NCT03503656|"~     Recently a computerized injection pump has been programmed with its own mathematical~     algorithm to measure on a digital display the pressure trend in the form of a continuous~     curve and it has been connected to an acoustic device that emits a sound at increasing~     frequencies during the progress of the epidural needle (Compuflo®, Milestone Scientific,~     Livingston, NJ); it has therefore been made capable of controlling the pressure at the~     injection point and adjusting the infusion rate according to a predetermined maximum value~     using the registered Dynamic Pressure Sensing (DPS) technology.~      The Compuflo® system guarantees feedback on simultaneous and continuous pressure data, both~     visual and auditory, identifying and differentiating the different types of tissue. This safe~     and effective feedback helps medical personnel to identify the epidural space with greater~     accuracy and alerts them if the needle moves into the identified position.~      The aim of the study was to verify the efficacy and usability of the Compuflo® system in a~     clinical setting.~      The setting was the area of gynecology and obstetrics at a tertiary referral level University~     Hospital.~      All the consecutive patients undergoing to an epidural catheter placement with Compuflo® were~     collected until to a sample size of 140 patients.~      Primary endpoint was the number and percentage of successes in the placement of epidural~     catheters with Compuflo® Epidural. Secondary endpoints were: the number and percentage of~     accidental dural punctures during epidural catheter placement; the number of attempts aimed~     at the correct positioning of the epidural catheter; the measurement of procedure time~     duration; the measurement of pressure in the interspinous ligament, in the yellow ligament~     and within the epidural space; the measurement of volume of saline injected by Compuflo® to~     identify the epidural space.~   "
4833|NCT03503643|"~     This is a prospective data collection of men who are electing to undergo prostate hemi-gland~     cryoablation.~      The purpose of this observational research study is to investigate the localized treatment of~     prostate cancer using hemi-gland cryoablation.~      UCLA patients undergoing hemi-gland cryoablation are a unique cohort compared to prior~     research because all patients at UCLA have had a pre-treatment multi-parametric MRI and~     Ultrasound fusion targeted biopsy; they will be followed in a similar fashion. This results~     in more precise assessment of a target region of cancer for ablation which may, in turn,~     result in improved clinical outcomes.~   "
4834|NCT03503630|"~     The purpose of this study is to show that the addition of COMPOUND 2055269, an~     immunotherapeutic drug, to Folfox chemotherapy will improve the pathologic complete response~     rate in patients with locally advanced rectal cancer.~   "
4835|NCT03503617|"~     We will investigate the efficacy of a newly developed exercise device (RehabTouch) for people~     in the subacute stage after a stroke compared to a traditional tabletop exercise program.~     RehabTouch uses embedded sensors that can track and record the patient's direction and degree~     of movement as they perform exercises described on a computer.~   "
4836|NCT03503604|"~     hPV19 is a monoclonal antibody (mAb) directed against vascular endothelial growth factor~     (VEGF). hPV19 binds to human VEGF with unique binding site on VEGF different from that of~     Bevacizumab(Avastin) and inhibits the binding of VEGF to it's receptors, VEGF-R1 and VEGF-R2.~     By preventing VEGF binding to its receptors, growth of tumor blood vessels are inhibited and~     tumor growth prevented or slowed. In this study we are investigating the tolerability,~     safety, pharmacokinetics and anti-tumor activity of hPV19 in combination with chemotherapy in~     patients with solid tumors. hPV19 will give to patients by intravenous(i.v.) infusion with a~     single and multiple doses.~   "
4837|NCT03503591|"~     The objective of this study is continued commercial evaluation of the intraoperative safety~     and performance of the H-TTS for the placement of ventilation tubes in pediatric patients~     undergoing a tympanostomy procedure under moderate sedation and local anesthetic.~   "
4838|NCT03503578|"~     The investigators are performing this research study to find out how and where the anesthetic~     drugs sevoflurane and ketamine act in the brain. Sevoflurane and ketamine are anesthetics (a~     drug or agent used to decrease or eliminate the feeling of pain by causing unconsciousness).~     The investigators will study the brain using a machine that records the brain's electrical~     activity, called an electroencephalogram (EEG).~   "
4839|NCT03503565|"~     During one-lung ventilation in thoracic surgery, the intensity of neuromuscular blockade may~     change the compliance and resistance of ventilated lung, thereby affecting postoperative~     atelectasis. The present study investigated the effect of the intensity of intraoperative~     neuromuscular blockade on the postoperative atelectasis using chest computerized tomography~     in patients receiving thoracic surgery requiring one-lung ventilation.~   "
4840|NCT03503552|"~     This project aims to ascertain that novel imaging and metabolic markers can be used to~     identify as well as to validate and improve the detection of Singapore-Chinese women at~     increased risk of diabetes.~   "
4842|NCT03503526|"~     This study is a mixed methods randomized controlled trial (Wait List Control), that~     investigates the effects of Group Music and Imagery (GrpMI) therapy in the treatment of women~     suffering from Post Traumatic Stress Disorder (PTSD) or Complex PTSD.~      The aim is to detect if the intervention has an effect on PTSD symptoms, dissociation,~     quality of life, and the capability of regulating the autonomic nervous system (ANS).~   "
4844|NCT03503500|"~     The so-called biological nurturing (BN) - or laid-back breastfeeding (LB BF), a new~     neurobehavioral approach to breastfeeding (BF), has the potential to enhance BF initiation~     and to reduce breast problems (pain, fissures, etc.), while easing the newborn attachment to~     the breast. BN focuses on facilitating the mother to breastfeed in a relaxed, laid-back~     position, with her baby laying prone on her, so that the baby's body is in the largest~     possible contact with mother's curves. This position opens up the mother's body and promotes~     baby's movements through the activation of 20 primary neonatal reflexes stimulating BF.~     Neurophysiological studies show that, through this approach, infants instinctively know how~     to feed, thanks to the presence of neonatal reflexes, at the same time mothers being able to~     instinctively activate the same reflexes.~      The main objective of this study is to assess the effectiveness of LB BF compared to standard~     hospital practices on the frequency of breast problems (i.e., pain, fissures, etc.) at~     discharge.~   "
4845|NCT03503487|"~     New devices for anatomic studies and 3-D visualization have proven to be useful for~     pre-operative surgical planning and intra-operative procedures; the hypothesis of our study~     is that, in this specific case scenario, Surgical Theater and Vesalius (two devices available~     at the Besta NeuroSim Center, Foundation I.R.C.C.S. Neurological Institute Carlo Besta) can~     improve doctor-patient communication during the process of obtaining informed consent:~     through tridimensional representation of anatomic structures of the brain, these devices are~     able to help patients understand better their own anatomy and the surgical approach to their~     disease.~      The aim of our study is therefore to understand whether this high-technology 3D planning,~     used as a tool to optimize patient-doctor communication, can effectively improve patients'~     understanding of the disease and the surgical procedure they will be going through (for which~     they are supposed to sign the consent), as well as the benefits, the risks and all the~     possible complications that can derive form surgery.~      Surgical Theater and Vesalius may be of great help: thanks to the case-specific 3D~     reconstruction of the patient's anatomy, the explanation of the surgical procedure could be~     customized for each different person, considering that anyone has certain unique individual~     features that a regular standardized system could not possibly take into account.~   "
4846|NCT03503474|"~     Clostridium difficile infection (CDI) is the most common cause of antibiotic associated~     diarrhoea in the western world. The infection causes significant diarrhoea, which in some~     cases can be serious and lead to secondary complications and even death. The infection is~     particularly an issue in elderly, frail patient, who are often already burdened with several~     other medical issues. Recent work has demonstrated that numerous cases are missed, either due~     to inadequate diagnostic tests or lack of clinical suspicion.~      The public-private partnership in COMBACTE-CDI will quantify the burden of CDI via a large,~     complex, multi-centre, multi-country study, and describe current management practices. An~     increased understanding of the CDI burden across Europe and better understanding of~     transmission of the organism will provide a basis for the further development of public~     health interventions and practices.~      Based on a previous successful study model (EUCLID), hospitals/laboratories of interest which~     carry out diagnostic testing of samples from both in-patients and community patients~     (including Long-Term Care Facilities patients) will be approached for inclusion in the study.~     Samples sent to the sites on the selected study date (regardless of test requested) will be~     tested at a central laboratory for CDI to look for missed cases of CDI. A follow up~     case/control study will collect data on outcomes and risk factors. Data will be used to~     construct transmission models and cost effective-ness models. Ultimately, a best practice~     model for CDI management will be developed.~   "
4847|NCT03503461|"~     Hypertension is common disorder after renal transplantation and is associated with mortality.~     Calcineurin Inhibitor (CNI), by activating NCC cotransporter, may be a major determinant of~     hypertension, included in a Gordon like syndrome. However, prevalence of NCC activation by~     CNI is unknown. Our objective is to determine the prevalence of NCC activation three months~     after transplantation in patient treated by CNI.~   "
4848|NCT03503448|"~     This study evaluates 2 Techniques of Surgically Assisted Rapid Maxillary Expansion (SARME) in~     the treatment of maxillary transverse deficiency. Half of participants will undergo an~     osteotomy between the maxillary central incisors, while the other half will undergo an~     osteotomy between the maxillary lateral incisors and canines (bilateral osteotomies).~   "
4849|NCT03503435|"~     Total laryngectomy (TL) patients suffer from a myriad of psychological and physiological~     difficulties following surgery. One of their main difficulties in communication due to~     problems in speaking. Art therapy offers an alternative means of communication via visual art~     making and has been shown to reduce psychological distress in cancer patients. Thus the goal~     of our study is to examine the effect of participating in a group art therapy session on the~     psychological and physical well being of TL patients. Our design is a quasi-experimental~     qualitative study with a pre-post design, collecting data with validated questionnaires,~     physiological measures and self-reports of the participants.~   "
4865|NCT03503227|"~     This study is a prospective, double-blind, randomized controlled trial . It includes 250~     infertile patients scheduled for ICSI cycle. The patients will be randomly allocated into two~     equal groups; daily oral low dose Acetylsalicylic acid and group B patients will receive~     daily oral low dose Acetylsalicylic acid and Low dose prednisolone. Both patients and outcome~     assessors are blinded to allocated group. All 250 participants undergo similar ICSI cycles.~     Primary outcome is clinical pregnancy rate per cycle. Secondary outcomes include number of~     oocytes retrieved, fertilization rate, number of embryos, embryo quality, chemical pregnancy~     rate, twins rate and miscarriage rate per cycle.~   "
4866|NCT03503214|"~     Alterations of acid-base equilibrium are very common in critically ill patients and~     understanding their pathophysiology can be important to improve clinical treatment.~      The human organism is protected against acid-base disorders by several compensatory~     mechanisms that minimize pH variations in case of blood variations in carbon dioxide content.~     The aim of the present study is to quantify the buffer power, i.e. the capacity to limit pH~     variations in response to carbon dioxide changes, in critically ill septic patients and~     compare these results with data collected from healthy volunteers.~   "
5495|NCT03494933|"~     The objective of the study is to demonstrate that in patients with chronic heart failure who~     receive optimal medical treatment for this condition and have indication for Cardiac~     Resynchronisation Therapy, the implantation of a pacemaker (index group) is not inferior to~     defibrillator (control group) with respect to all-cause mortality.~   "
4850|NCT03503422|"~     Chronic low back (CLBP) pain is an important public health and socioeconomic problem~     worldwide and, despite the volume of research in the area, it remains a difficult condition~     to treat. The Neuromatrix pain model and new findings on the pain chronification process~     point to a greater efficacy of treatments that address central and peripheral rather than~     only peripheral structures.~      Transcranial direct current (tDCS) stimulation is a noninvasive neuromodulation technique~     that has been presenting recent advances in the treatment of chronic pain. However, when~     applied alone the magnitude of its effect is small in chronic musculoskeletal conditions such~     as chronic non-specific back pain. One option that could optimize the analgesic effect of~     tDCS would be the combination with therapeutic exercises, which play a central role in spinal~     rehabilitation programs as well as higher levels of evidence. The combination of these~     treatments (tDCS and exercise) may present an analgesic effect superior to the isolated~     interventions.~      This study aims to investigate the efficacy of tDCS combined with therapeutic exercises in~     people CLBP for pain relief, affective aspect of pain, disability, kinesiophobia and global~     perception. Sixty patients will be randomized into two distinct groups to receive either tDCS~     (anodal) + therapeutic exercises or tDCS (sham) + therapeutic exercises for 12 sessions over~     a four-week period. The primary clinical outcome (pain relief) and secondary outcomes~     (disability, affective aspect of pain, kinesiophobia, and perception of overall effect) will~     be collected before treatment and four weeks, three months and six months post randomization.~     The data will be collected by a blind examiner to the treatment allocation.~   "
4851|NCT03503409|"~     patients with MDS (Myelodysplastic Syndrome) and mutated IDH1 patients will be treated with~     AG120 (IDH1 inhibitor)~   "
4852|NCT03503396|"~     This is a pilot study to set up a larger investigation examining predictors of the decision~     to drive after consuming alcohol. All participants will carry a study provided smartphone and~     breathalizer device for the 2 week period of the study. The intervention is that participants~     are randomly assigned to one of 2 breathalizer feedback conditions - one where they receive a~     warning that their results indicate they should not drive and one where they receive no~     feedback. The study is designed to provide information needed for a larger version with a~     similar protocol, but also to provide an initial test of project hypotheses as well.~   "
4853|NCT03503383|"~     This study is a case controlled study comparing mental health status and some psychological~     impacts between two groups of patients first group is pregnant women without any other~     medical disorder during pregnancy,the second group is pregnant women complaining of~     hypertension with pregnancy.~   "
4854|NCT03503370|"~     Foot complications are among the most serious and costly complications of diabetes. People~     with diabetes have a 10-fold increased risk for a leg or foot amputation compared to those~     that do not have diabetes. Amputation of all or part of foot is usually preceded by a foot~     ulcer, which became infected. This is a clinical trial to test the effectiveness of a topical~     antiseptic, chlorhexidine, for daily foot cleaning on the recurrence of diabetic foot ulcers~     in Veterans with a recent history of a foot ulcer.~   "
4855|NCT03503357|"~     ConsCIOUS-2 is a multi-site study exploring the cognitive state of the Isolated Forearm Test~     (IFT) responder while under anesthetic.~   "
4856|NCT03503344|"~     This phase II trial studies the how well apalutamide with or without stereotactic body~     radiation therapy work in treating participants with castration-resistant prostate cancer.~     Testosterone can cause the growth of prostate cancer cells. Hormone therapy using apalutamide~     may fight prostate cancer by blocking the use of testosterone by the tumor cells.~     Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays~     directly to the tumor using smaller doses over several days and may cause less damage to~     normal tissue. It is not yet known whether giving apalutamide with or without stereotactic~     body radiation therapy works better in treating participants with castration-resistant~     cancer.~   "
4857|NCT03503331|"~     The primary objective of this study is to measure the concentration and the regional brain~     distribution of pathologic amyloid deposition using the PET tracer [C-11]PiB in participants~     in the UAB Alzheimer's Disease Center cohort. Assessment of interactions between race and~     vascular risk factors, brain amyloid levels measured with [C-11]PiB-PET, and cognitive status~     will be the primary outcome of this imaging study.~   "
4858|NCT03503318|"~     The purpose of the study is to evaluate the efficacy, safety, and tolerability of different~     dose regimens of TV-46000 administered subcutaneously as compared to placebo during~     maintenance treatment in adult patients with schizophrenia. The study will include male and~     female patients, 18 to 65 years of age, who have a confirmed diagnosis of schizophrenia, are~     clinically stable, and are eligible for risperidone treatment.~   "
4859|NCT03503305|"~     This is a prospective, randomized, double-blinded, active controlled, single site safety and~     efficacy study in subjects suffering from chronic wrist osteoarthritis comparing a single~     ADRC injection generated with the Transpose® RT system into the wrist.~   "
4860|NCT03503292|"~     The Researchers overall goal is to evaluate the benefit and utility of preemptive genotypic~     data to guide post-operative nausea and vomiting treatment in the bariatric surgical~     population. The hypothesis is that using genotypic variation in CYP2D6 to select the~     appropriate 5HT3 serotonin receptor antagonist to treat PONV will decrease rates of PONV in~     the bariatric surgical population.~   "
4861|NCT03503279|"~     The purpose of this clinical study is to assess the difference in intubation difficulty scale~     (IDS) score after the placement of the endotracheal tube placement (i.e. insertion of a~     breathing tube through the mouth into the airway) that will occur at the beginning of general~     anesthesia (i.e. combination of drugs to sedate and put you to sleep during surgery) with~     TotalTrack Video Laryngeal Mask (VLM) versus conventional intubation with Macintosh curved~     laryngoscope in adult patients. Both devices are approved by the US Food & Drug~     Administration (FDA) for clinical use in patients. Pending partial HIPAA waiver approval,~     potential subjects will be identified via review of surgery schedule on IHIS. Patients~     undergoing qualifying surgeries and fit the inclusion/exclusion criteria will be approached.~     Patients will be consented prior to surgery in a private room in the pre-operative area prior~     to the administration of any medications that might affect their cognitive ability. The~     patient will be given an opportunity to either accept or decline involvement. If he/she~     declines to participate in this research study, no changes will be made to surgical or~     anesthesia care, and procedure will proceed as originally planned. If the patient agrees to~     participate in this research study, the following procedures will occur as part of your~     participation: After the subject has signed the informed consent, a research staff member~     will record information about their medical history including allergies (seasonal and drug~     related), demographics (gender, age, years of education, race, and ethnicity), history of~     alcohol or drug abuse, history of smoking, and history of postoperative nausea or vomiting.~     All medication they have taken 7 days prior to surgery will also be recorded. In addition,~     the subject will be randomly assigned (like flipping coin) to either the TotalTrack VLM or~     the Macintosh curved laryngoscope. The subject has a 50/50 chance of being assigned to the~     either device. The surgeon and anesthesiologist will perform routine examinations related to~     surgery. This includes a physical examination and airway assessment, which are standard~     before any surgical procedure. If the patient decides to take part in this study, the~     anesthesiologist will perform additional assessments to further examine and characterize~     their airway. This will determine whether or not the anesthesiologist anticipates controlling~     your breathing during surgery (airway management) will be more difficult than usual. If your~     anesthesiologist deems it appropriate, he/she will use the TotalTrack VLM or the Macintosh~     curved laryngoscope for airway management according to the randomization group the subject~     has been assigned. These devices are used while the subject is unconscious; the subject will~     not be awake while they are being utilized. The TotalTrack VLM consists of disposable parts~     connected to a reusable camera. The reusable portion will be properly cleaned between uses~     per Videotrack Instructions for Use (uploaded). Additionally, vital signs (blood pressure,~     heart rate, etc) and oxygenation measurements will be recorded using our standard monitoring~     devices that the physician places as part of your routine standard of care. This data will be~     collected right before, during and 5 minutes after intubation. Following intubation, after~     surgery is complete, both devices will be removed and the anesthesiologist will awaken the~     subject. In the recovery room, he/she will perform another airway assessment. This will~     evaluate the characteristics of the subject's airway after surgery. The research staff will~     record these results. Later, the research staff will conduct a follow up phone call with the~     subject one week after surgery (5-9 days). After this call, research participation is~     complete.~   "
4862|NCT03503266|"~     This is a single-centre, open-label, mass balance study in healthy male subjects utilising a~     single oral dose of [14C] MT 7117.~   "
4863|NCT03503253|"~     Although the clinical impact of left atrial appendage (LAA) leaks still requires~     confirmation, the open pouch with residual flow resulting from incomplete LAA closure may~     promote blood stagnation and thrombus formation, and increase the risk of thromboembolic~     events. The main purpose of this trial is to evaluate the safety and efficacy of percutaneous~     leak closure with detachable vascular coils.~   "
4864|NCT03503240|"~     The purpose of this study is to evaluate patient satisfaction and quality of life as it~     relates to skin cancer surgery. This research study involves taking a one-time survey online.~   "
4879|NCT03503045|"~     This study evaluates the overtreatment and deintensification rates of antidiabetic and~     antihypertensive medications in patients with diabetes mellitus in Turkey.~   "
13158|NCT03394612|"~     This phase II trial aims to evaluate the efficacy and safety of EHSG-KF (synonym denovoSkin)~     in comparison to meshed STSG in adults and children with full-thickness Skin defects.~   "
4867|NCT03503201|"~     This study is a prospective, double-blind, randomized controlled trial . It included 60~     infertile obese patients with polycystic ovary syndrome (PCOS), who are scheduled for~     intracytoplasmatic sperm injection (ICSI) cycle. The patients will be randomly allocated into~     two equal groups; Group (A): patients receive chromium supplementation as capsules of 200~     micrograms of chromium picolinate (Arab company for pharmaceuticals and medicinal plants),~     Group (B): no chromium supplementation. Both patients and outcome assessors are blinded to~     allocated group. All 60 participants underwent similar ICSI cycles. Primary outcome is~     clinical pregnancy rate per cycle. Secondary outcomes include number of oocytes retrieved,~     fertilization rate, number of embryos, embryo quality, chemical pregnancy rate, twins rate~     and miscarriage rate per cycle.~   "
4868|NCT03503188|"~     The aim of this study is the data collection for patients with IPF and symptom matched~     controls to create a database of lung auscultation sounds and basic patient characteristics.~   "
4869|NCT03503175|"~     Cystoscopy is a commonly performed procedure after gynecologic surgery, however, its use may~     increase patients' risk for acquiring urinary tract infections due to urinary tract~     instrumentation entry and reentry of the lower urinary tract with the cystoscope and foley~     catheter. Use of a novel multi-channel transurethral bladder catheter that allows for~     cystoscopy through a specialized port will permit cystoscopy to be performed without catheter~     removal. This may allow for intraoperative detection of urinary tract injuries with a~     reduction in both urethral manipulation and hospital-associated urinary tract infections.~     Other potential benefits may include a shorter procedure time and ease of use for providers.~   "
4870|NCT03503162|"~     The aim of this study is to evaluate the potential improvement in colonoscopy procedure's~     outcomes when using the Pure-Vu System in hospitalized patients who are indicated for~     colonoscopy procedure.~   "
4871|NCT03503149|"~     Molecular Tumor Board at the Center for Personalized Medicine~   "
4872|NCT03503136|"~     This is a phase 3, multicentre, non-inferiority, randomised factorial trial. The purpose of~     this study is to study the efficacy and safety of nedaplatin versus cisplatin, and~     capecitabine versus fluorouracil in induction docetaxel, cisplatin, and fluorouracil (TPF)~     plus concurrent chemoradiotherapy with cisplatin (P-RT) in locoregionally advanced~     nasopharyngeal carcinoma (NPC).~   "
4873|NCT03503123|"~     Non-invasive ventilation (NIV) has shown to be an effective therapy for patients with Chronic~     Obstructive Pulmonary Disease (COPD) with Chronic Hypercapnic Respiratory Failure (CHRF).~     However, these COPD patients often report severe dyspnoea after switching off from NIV~     therapy, which leads to discomfort and distress. Currently, it is not known what causes this~     deventilation dyspnoea and therefore a possible treatment to prevent deventilation dyspnoea~     is not available. This study investigates possible mechanisms underlying the phenomenon of~     deventilation dyspnoea in COPD patients by monitoring the effects of NIV on the patient~     during an afternoon sleep.~   "
4874|NCT03503110|"~     Elucidating the structure-function relationship of the brain is one of the main open~     questions in neuroscience. The capabilities of diffusion MRI-based (dMRI) techniques to~     quantify the connectivity strength between brain areas, namely structural connectivity (SC),~     in combination with modalities such as electroencephalography (EEG) to quantify brain~     function have enabled advances in this field. However, so far the actual relationship between~     SC measures and measures of information transport between neuronal patches has not been~     determined. In this project, we aim to establish a relationship between dMRI SC measures,~     direct measures of electrical properties of the human brain cortex obtained with~     electrocorticography (ECoG), and response elicited by direct electrostimulation of the brain~     (DES). Ten patients operated on awake surgery for brain tumor removal will be included.~     First, a dMRI will be acquired prior to the surgery, in order to extract SC indices through~     probabilistic tractography. Then, intrasurgical cortico-cortical electrical measures will be~     obtained by ECoG electrodes positioned on the predefined cortical terminations of the~     designated bundles. These measures will be correlated to functional responses obtained during~     the cortical cartography, following the common DES procedure. The results of this multi-modal~     approach combining structure and function explorations of the brain should help to elucidate~     the relationship between non-invasive (dMRI) SC measures and cortico-cortical transmission~     properties (delays, transfer functions), and should boost the understanding of cognitive~     function as well as neurosurgical planning for the treatment of pathologies such as brain~     tumor resection and drug-resistant epilepsy.~   "
4875|NCT03503097|"~     This research study provides genetic testing to men with prostate cancer that has spread to~     other parts of the body (metastatic prostate cancer) and will look for inherited genetic~     mutations in about 30 cancer-risk genes. The researchers seek to learn about the~     participant's opinions and concerns about genetic testing, to determine if this is an~     acceptable way to deliver testing and to potentially help guide the participant's treatment.~     Neither treatment nor any decisions related to treatment will take place on this study, but~     researchers will share each participant's genetic testing results with that participant.~   "
4876|NCT03503084|"~     The short term effects of TCC exercise are the significant increase in serum insulin and~     insulin resistance, and the significant decrease in serum TC, HDL-C, ET-1 and insulin~     sensitivity in TCC practitioners. TCC might be benefit the health of its practitioners~     through the regulation of lipid and glucose metabolism and endothelial function.~   "
4877|NCT03503071|"~     Cytoreductive surgery with intraperitoneal chemotherapy is one of the most important~     treatments for patients with colorectal cancer and peritoneal metastasis. For the best~     survival rates, complete removal of all metastatic lesions is the most important part of~     treatment, and various surgical procedures are required for the complete cytoreduction.~     Therefore, the postoperative morbidity rates are higher than those of localized colon cancer~     surgeries and patients can experience a prolonged recovery period and deterioration of~     physical activities over a long period. The aim of this study is to investigate the change of~     quality of life after cytoreductive surgery and intraperitoneal chemotherapy for colorectal~     cancer.~   "
4878|NCT03503058|"~     The study is a single site, double-blind, randomized, placebo-controlled clinical trial that~     will assess the safety, tolerability, immunogenicity and vaccine efficacy (VE) of PfSPZ~     Vaccine and PfSPZ-CVac against naturally occurring malaria in Indonesian soldiers deployed to~     eastern Indonesia.~   "
4881|NCT03503019|"~     A prospective multicenter study including all patients undergoing elective total hip (THA) or~     knee (TKA) arthroplasty (primary and revision). Patients will be screened for glycemic~     control using HbA1c levels, fructosamine levels, and blood glucose levels. Blood samples will~     be obtained at the preadmission testing (PAT) within 30 days of surgery. On postoperative day~     1 (POD-1), morning glucose levels will be obtained for all patients as well. Patients will be~     followed up for 90 days postop.~      Study aims~        1. To examine the association between serum fructosamine levels and the risk for adverse~          outcomes (mainly PJI) following TJA among patients with and without diabetes.~        2. To compare the utility of fructosamine levels to HbA1c in predicting adverse outcomes.~        3. To determine the best threshold of fructosamine to determine adverse outcomes.~   "
4882|NCT03503006|"~     At present, there is no agreement on the effect of vitamin D level in serum and follicular~     fluid on the outcome of IVF-ET pregnancy. Most of these studies were based on the research of~     total 25 (OH) D, which have ignored that the biological activity of vitamin D molecule is not~     total 25 (OH) D, but free vitamin D or vitamin D bioavailable, and have flaws in methodology.~     This project intends to make a prospective cohort study with large sample, based on a~     complete methodology of total vitamin D and free vitamin D to measure maternal vitamin D~     levels in blood,to systematically study the effect of maternal vitamin D status on IVF - ET~     pregnancy outcome. This study is also the first to study the relationship between maternal~     vitamin D status and the outcome of IVF-ET pregnancy using a complete methodology.~   "
4883|NCT03502993|"~     Childhood fever is a prevalent problem. Most febrile children who visit hospital improve~     without treatment, but a minority require treatment, and a few will have severe disease. The~     investigators want to improve the diagnosis and management of febrile children by developing~     tests to distinguish between bacterial and viral disease so that antibiotic treatment can be~     initiated promptly and only when required. Judicious and prudent use of antibiotics will~     reduce the likelihood of developing resistant organisms and save treatment costs.~      There are two parts to recruitment in this study; the first is to assess the management and~     outcome of febrile children who seek medical treatment in hospital (MOFICHE study). The data~     will be used to model management strategies for febrile children and enable a~     cost-effectiveness analysis.~      Secondly the investigators will prospectively recruit acutely febrile children presenting to~     hospital, collecting research samples for validation of biomarkers, in combination with~     clinical phenotypic markers and host genetic markers (BIVA-studies).~      Any febrile child newborn to under 18 presenting to hospital will be eligible for~     recruitment. The study will last 5 years.~   "
4884|NCT03502980|"~     The purpose of this study is to assess the non-inferiority for safety and efficacy of using~     Midline in comparison with PICC for intravenous therapy that do not require a central~     catheter.~   "
4885|NCT03502967|"~     This project is to evaluate sensitivity and specificity of hyperpolarized 13C-pyruvate as~     imaging agents of altered cerebral glycolysis and mitochondrial dysfunction and assess~     pyruvate utilization in mitochondria in Traumatic Brain Injury (TBI) patients.~   "
4886|NCT03502954|"~     The purpose of this first-in-human study is to investigate the safety and tolerability of~     ABY-039 after single and multiple doses in healthy volunteers.~   "
4887|NCT03502941|"~     Sarcopenia, a progressive loss of muscle mass, strength and function, is an inevitable~     natural process of aging. While it may be impossible to completely reverse the progress of~     sarcopenia, it is well established that intake of dietary protein through essential amino~     acids (EAAs) and whey protein increases anabolic response. The current study will test if a~     specially formulated mixture of EAAs and whey protein can maximally stimulate anabolic~     responses at the levels of whole body and muscle compared to whey protein alone.~   "
4888|NCT03502928|"~     INTRODUCTION: Whiplash is an injury produced by an acceleration-deceleration mechanism that~     transmits energy to the cervical spine. According to the bibliography, the conservative~     treatment (motor control exercises and manual therapy) has shown benefits in approaching this~     lesion, but its efficacy is limited. Dry needling has already shown its usefulness in~     different musculoskeletal pathologies, however, its efficacy is unknown when it is included~     in conservative treatment.~      OBJECTIVES: The objective of this study is to assess the effects of the incorporation of dry~     needling in the conventional treatment with manual therapy and motor control exercises,~     compared to the conventional non-invasive treatment in patients with acute or subacute~     whiplash.~      HYPOTHESIS: The inclusion of dry needling in conventional non-invasive treatment is more~     effective than conventional non-invasive treatment in patients with acute or subacute~     whiplash.~      METHODS: A randomized clinical trial will be conducted in which the subjects of study will be~     assigned to two groups, a control group (conventional treatment) and an experimental group~     (conventional treatment and dry needling).~   "
4889|NCT03502915|"~     This study seeks to determine the effectiveness of nitrous oxide in reducing the anxiety and~     pain associated with external cephalic version (ECV); a maneuver to turn the fetus from~     breech to cephalic position.~   "
4890|NCT03502902|"~     A Phase I, Double-blind, Placebo-controlled, Single Oral Dose, Safety, Tolerability, and~     Pharmacokinetic Study, Incorporating an Evaluation of the Effect of Food on the~     Pharmacokinetics of HEC68498 in Healthy Male and Female Subjects~   "
4891|NCT03502889|"~     This is a prospective, randomized control trial to compare SPANK block combined with adductor~     canal block to adductor canal block alone in treatment of post-operative pain after total~     knee arthroplasty. The primary outcome is pain control, which will be measured throughout the~     post-operative course using morphine equivalents of opioid analgesics used during the first~     24 hours after surgery. Secondary outcomes include pain scores recorded at 4, 8, 12, 16, 20,~     and 24 hours post-operatively, cumulative pain score, incidence of post-operative nausea and~     vomiting, and extent of motor blockade. The study will aid in answering the question of~     whether SPANK block is an effective adjunct in preventing pain and decreasing opioid~     requirement after TKA.~   "
4892|NCT03502876|"~     Assessment of the mutational profile of the residual clone and the distribution of lymphocyte~     subpopulations at 3 years of treatment with ibrutinib~      This project has an epidemiological part: to establish the percentage of patients, in a~     real-life situation, still undergoing treatment 3 years after its initiation, as well as a~     biological part: to determine the evolution of the clone and the prevalence of BTK mutations~     and PLCg2 in the absence of clinical or biological criteria for scalability.~   "
4899|NCT03502785|"~     This is a Phase I/IIA, open-label, multi-center trial to evaluate the safety, immunogenicity~     and preliminary clinical efficacy of INO-5401 + INO-9012 delivered by intramuscular (IM)~     injection followed by electroporation (EP), in combination with atezolizumab in participants~     with locally advanced unresectable or metastatic/recurrent Urothelial Carcinoma (UCa). The~     trial population is divided into two cohorts: Cohort A: Participants with locally advanced~     unresectable or metastatic/recurrent UCa, who have confirmed disease progression during or~     following treatment with anti-Programmed Death receptor-1/Programmed Death receptor Ligand-1~     (anti-PD-1/PD-L1) therapy; Cohort B: Participants with locally advanced unresectable or~     metastatic/recurrent UCa, who are treatment naïve and ineligible for cisplatin-based~     chemotherapy. A safety run-in will be performed with up to six participants (safety analysis~     participants) from cohort A.~   "
4900|NCT03502772|"~     Multiple sclerosis (MS) is a chronic-progressive and neurodegenerative disease. Thus,~     exercise programs are needed to maintain and increase functional status of persons with MS~     (pwMS). Pilates exercises designed by physiotherapist can enhance participation and~     functionality in pwMS. The aim is to investigate the effects of a clinical Pilates training~     on balance, walking, fall risk, respiratory and cognitive functions in pwMS.~      Forty-two pwMS will be included in this randomized controlled trial. Participants will be~     divided into two groups with stratified randomization. Pilates exercises group (n=21) will~     receive therapy once a week for 8 weeks plus home exercise programme. The home exercise~     program group (n = 21) will be given written exercises that matched the aims of the Pilates~     exercises and the program compliance will be monitored by telephone calls once a week. The~     assessments will be done twice at the beginning and at the end of the treatment. The outcome~     measures include the Timed 25-Foot Walk (T25FW), Six-Minute Walk Test (6MWT), Timed Up and Go~     (TUG), TUG cognitive and manual forms, 12-Item Multiple Sclerosis Walking Scale (MSWS-12),~     Curl-Up Test (CUT), Falls Efficacy Scale-International (FES-I), Activities-specific Balance~     Confidence (ABC) Scale, respiratory muscle strength assessment, Brief International Cognitive~     Assessment for MS (BICAMS).~   "
4901|NCT03502759|"~     Children with generalized tonic-clonic seizures (GTCS) have about a 1 in 4500 of succumbing~     to sudden unexpected death in epilepsy (SUDEP). For that reason, the American Academy of~     Neurology recommends that clinicians caring for these children make their families aware of~     this small but important risk and provide appropriate supportive follow-up resources.~     Moreover, existing evidence suggests that children with poorly controlled GTCS have a~     strikingly increased odds of SUDEP, 3-24 fold, raising the importance of improving seizure~     control.~      Clinicians caring for these patients have multiple issues to address in the typical visit.~     The investigators propose to use information technology to help providers assure that~     addressing SUDEP is incorporated into their routine care. The investigators have developed~     the Child Health Improvement through Computer Automation system (CHICA), a computer based~     clinical decision support system for pediatric care. CHICA captures patient reported data in~     the waiting room and prioritizes clinical advice to the physician through the electronic~     health record (EHR).~      CHICA is used in five primary care clinics in the Eskenazi health system where it supports~     general pediatric care. The goal of this project is to test the effectiveness of a SUDEP~     module in this setting where CHICA is already in use - with a future goal of developing a~     full suite of CHICA modules for child neurologists.~   "
4902|NCT03502746|"~     This study will evaluate the combination of Nivolumab and Ramucirumab in patients with~     previously-treated mesothelioma.~   "
4903|NCT03502733|"~     This phase Ib trial studies the side effects and best dose of copanlisib and nivolumab in~     treating patients with solid tumors that have spread to other places in the body or lymphoma.~     Copanlisib stops tumors from growing by blocking proteins that are known to be important for~     tumor cell growth. Monoclonal antibodies, such as nivolumab, may unblock the immune system so~     that it can recognize and attack tumor cells. Giving copanlisib and nivolumab may work better~     in treating patients with solid tumors or lymphoma.~   "
4904|NCT03502720|"~     The investigators want to analyse the advantages of using a 3D constructed prototype from a~     previous CT Scan to model an external customised guide por percutaneous Scaphoid fixation.~      The investigators hypothesise that the usage of this device will shorten surgery time,~     radiation for the surgery team and optimise the percutaneous screw trajectory inside of the~     scaphoid bone.~   "
4905|NCT03502707|"~     The purpose of this study for:~      Cohort 1 and Cohort 2: to assess the safety and reactogenicity of the intramuscular one- and~     two-dose regimens, with a booster at Month 12 and to select a regimen for Cohort 3.~      Cohort 2 and part of Cohort 1: to assess respiratory syncytial virus (RSV) neutralizing~     antibody levels of all regimens containing RSV pre-fusion (preF) protein compared to the~     one-dose adenovirus serotype 26 respiratory syncytial virus pre-fusion (Ad26.RSV.preF)~     regimen.~      Cohort 3: to demonstrate the non-inferiority of the concomitant administration of the~     selected regimen and seasonal influenza vaccine versus the administration of seasonal~     influenza vaccine alone in terms of humoral immune response expressed by the geometric mean~     titers (GMTs) of hemagglutination inhibition (HI) antibody titers against the influenza~     vaccine strains 28 days after the administration of influenza vaccine, using a~     non-inferiority margin of 2 for the GMT ratio (control group/co-administration group) and to~     assess the safety and reactogenicity of the selected regimen administered separately or~     concomitantly with seasonal influenza vaccine, and a booster at Month 12, and to compare the~     safety and reactogenicity of the co-administration group with that of the seasonal influenza~     vaccine + placebo group.~   "
4906|NCT03502694|"~     The purpose of this study is to determine in hospitalized adult participants infected with~     human metapneumovirus (hMPV - a virus closely related to respiratory syncytial virus (RSV)~     and has been identified as an important cause of acute respiratory infections, affecting all~     age groups) the dose-response relationship of multiple regimens of lumicitabine on antiviral~     activity based on nasal hMPV shedding using quantitative reverse transcriptase-polymerase~     chain reaction (qRT-PCR) assay.~   "
4907|NCT03502681|"~     This is a single arm, open-label phase Ib study of combining eribulin mesylate with avelumab.~     The initial 9-12 patients (MTD cohort) will be enrolled to determine safety of avelumab in~     combination with eribulin mesylate. Upon determination of maximum tolerated dose (MTD), 12~     additional patients will be enrolled in an expansion cohort (efficacy cohort) to determine~     ORR at 6 months.~   "
4908|NCT03502668|"~     Multicenter, open-label study of various ASTX727 LD doses and schedules to assess safety,~     pharmacodynamics, pharmacokinetics, and hematologic response in subjects with IPSS risk~     category of low-risk or Intermediate-1 MDS. In Phase 1 Stage A, subjects will be randomized~     in a 1:1:1 ratio into 3 cohorts of 6 subjects each in a 10-day schedule in 28-day cycles;~     when safety is established in Stage A, 24 evaluable subjects will be randomized in a 1:1:1:1~     ratio in Phase 1 Stage B into 4 cohorts of 6 subjects each in a 14-day schedule in 28-day~     cycles. In Phase 2, 40 new subjects will be randomized in a 1:1 ratio into 2 doses/schedules~     selected from Phase 1.~   "
4909|NCT03502655|"~     The main goal of this study is to investigate whether the communication between patients and~     healthcare providers has an impact on pain and anxiety induced by the insertion of a~     peripheral venous catheter in an emergency department. Another goal is to determine if the~     effect is mediated by the content of the message in itself or if it is mediated by non-verbal~     cues . Therefore, the message will be delivered by either an audio recording in the first~     phase of the study, and by the healthcare providers themselves in the second phase of the~     study. A secondary goal is to assess whether there are discrepancies between the patients'~     pain and anxiety reports and the healthcare providers' evaluation of the patient's pain and~     anxiety.~   "
4910|NCT03502642|"~     Cesarean delivery is one of the most common surgical procedures, performed at an increasingly~     high rate. It is associated with intense postoperative pain that may hamper the~     rehabilitation process and interfere with patient satisfaction and care provided to the~     newborn. Therefore, control of perioperative pain with multimodal regimens using local~     anesthetic may be important in short- and long-term convalescence after surgery.~      Opioid-based regimens are the gold standard of cesarean delivery analgesia. However, spinal~     and epidural opioids have a ceiling effect.~      Wound infiltration with local anesthetics has been used widely in the multimodal approach of~     pain relief. Continuous wound infusion with local anesthetic through a multiorifice catheter~     increases the duration of action and efficacy of local surgical wound infiltration compared~     with a one-time wound injection of local anesthetic.~      After cesarean delivery, Local anesthetic continuous wound infusion would be associated with~     better reduction in pain scores when compared to intrathecal morphine . Therefore, an~     assessor and patient blinded, randomized study that aimed to compare the efficacy and side~     effects of these analgesia techniques was conducted.~   "
4911|NCT03502629|"~     It is a multi-center, prospective, open-label, two-stage optimized design, single-arm, phase~     II clinical study to evaluate the efficacy and safety of GB226 for the treatment of relapsed~     and refractory peripheral T cell lymphoma (PTCL), and to evaluate the immunogenicity of~     GB226.~   "
4912|NCT03502616|"~     The purpose of this study is to determine if tofacitinib is safe and effective in subjects~     with active ankylosing spondylitis.~   "
4913|NCT03502603|"~     This study is aimed at investigating three new tests that will form part of a computerized~     tool designed to test brain/cognitive functioning. The system will be evaluated along with~     the tests' usability on samples of healthy controls and neurologically impaired patient~     participants. These new tests will be assessed with regard to reliability and validity.~     Reliability will be addressed through investigation of internal consistency of the test~     items. Validity will be evaluated relative to traditional paper-and-pencil tests and~     differentiation between patient and healthy participants.Each participant will complete both~     the computerized and paper and pencil-based tests. The results will be analyzed to see how~     performances on the two test types compare. The overall aim of this project is to determine~     if these new computerized tasks are an improvement over standard paper and pencil-based~     neuropsychological measures.~   "
4914|NCT03502590|"~     It is known that patients with head and neck cancer who have had radiation therapy to the~     structures of the neck are at a greater risk of difficult mask ventilation and tracheal~     intubation than the majority of patients undergoing general anaesthesia.~      Failure to maintain oxygenation can lead to catastrophic consequences for any patient~     undergoing general anaesthesia, such as severe hypoxic brain injury and death.~      As such, the current guidelines from the Difficult Airway Society promote the use of a second~     generation laryngeal mask airway to maintain oxygenation in the event of failed mask~     ventilation or tracheal intubation, a rescue technique that has in most patient groups a very~     high chance of success. Unfortunately these guidelines are by necessity generic guidance and~     do not take into account the clinical performance of these devices in specific patient~     groups. While there is evidence of the effectiveness of the IGEL device as the primary method~     of airway maintenance in many studies there are none that describe its clinical performance~     in a group of patients in whom the rate of failed mask ventilation and tracheal intubation~     are significantly higher than the general population of patients. It is therefore of great~     interest to have an idea of the likelihood of success of rescue ventilation with this device~     in a group of high risk patients.~   "
4915|NCT03502577|"~     This phase I trial determines the side effects and best dose of B-cell maturation antigen~     (BCMA)-chimeric antigen receptor (CAR) T-cells when combined with gamma-secretase inhibitor~     LY3039478 (LY3039478), cyclophosphamide, and fludarabine in treating participants with~     multiple myeloma that that has come back or remains despite treatment. Placing genes added in~     the laboratory into immune T-cells may make the T-cells recognize BCMA, a protein on the~     surface of cancer cells. LY3039478 may enhance the killing of cancer cells by increasing the~     BCMA expression on multiple myeloma cells, making the targeted BCMA CAR-T treatment more~     effective. LY3039478 also decreases the amount of BCMA found in the circulation (called~     soluble BCMA) that is not bound to the myeloma cells. LY3039478 can therefore reduce the~     potential for soluble BCMA to act as a decoy. Drugs used in chemotherapy, such as~     cyclophosphamide and fludarabine, work in different ways to stop the growth of cancer cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Giving BCMA CAR T therapy with LY3039478, cyclophosphamide, and fludarabine may~     work better in treating participants with relapsed or persistent multiple myeloma.~   "
5128|NCT03499756|"~     Postnatal depression is a common public health problem which has long-term sequelae on the~     family and the infant's psychosocial development. Interpersonal psychotherapy has~     demonstrated its value as one of the most effective interventions for postnatal depression.~     The aim of this study is to examine the effect of a couple-based interpersonal psychotherapy~     for first-time Chinese mothers and fathers on depressive symptoms, family sense of coherence,~     and marital relationships immediately after intervention and at 6 weeks and 6 months~     postpartum.~   "
4916|NCT03502564|"~     Although psychotherapy for eating disorders (EDs) can be effective, approximately 50% of~     those who complete a course of the best available therapy continue to have significant ED~     symptoms at the end of treatment. Posttraumatic stress disorder (PTSD) commonly co-occurs~     with EDs and is thought to be one reason why some individuals do not remit from their ED with~     best available treatment or relapse following treatment. In particular, ED behaviours can~     function as coping methods for PTSD symptoms, and thus interfere with successful and lasting~     ED recovery. The main objective of this initial treatment trial is to determine whether a~     concurrent treatment approach, in which PTSD symptoms are treated at the same time as ED~     symptoms, provides an advantage over standard ED treatment by successfully alleviating PTSD~     symptoms. Another objective of this study is to determine whether concurrent psychotherapy~     for EDs and PTSD is superior to standard ED treatment in improving associated symptoms~     including depression and anxiety.~      Forty participants who have both an ED and PTSD will be assigned to receive either (1)~     standard ED psychotherapy alone or (2) standard ED psychotherapy concurrent with PTSD~     psychotherapy. After treatment, participants will be followed for a period of 6 months to~     determine whether improvements made during therapy are maintained after treatment. ED and~     PTSD symptoms, as well as concomitant symptoms (e.g., anxiety and depression) will be~     assessed immediately before and after treatment, as well as 3 and 6 months after treatment.~   "
4917|NCT03502551|"~     This study aims to determine if a single intravenous (IV) dose of ketamine given in the~     emergency department (ED) can provide a long term reduction in suicidal ideation, lower time~     to ED discharge, and increase discharge to home or voluntary treatment facilities all while~     being safe.~   "
4918|NCT03502538|"~     Objective: To compare the efficacy of Curaprox® CS 5460 Ultra Soft and Oral-B® Indicator Plus~     toothbrushes in dental plaque removal. Methods: 50 adult participants will be included in the~     sample. For a period of 24 hours (at two different times), they will be instructed to stop~     oral hygiene. During the final 4 hours, the interruption of consumption of foods and liquids~     will be recommended, and in smokers' case, the use of cigarettes. In two clinical visits (T0~     and T1), volunteers will be asked to brush their teeth for 1 minute with Curaprox® (CS 5460~     Ultra Soft) e Oral-B® (Indicator Plus) toothbrushes. Disclosure will be performed prior to~     and after brushing and the presence of plaque on the tooth surfaces will be evaluated.~     Turesky Modified Quigley Hein Plaque Index will be used for the plaque record. For~     statistical analysis, paired t tests will be performed to compare the effectiveness of~     toothbrushes and correlation test to assess whether the fact that the patient was aware of~     the toothbrush that will be used influenced in their performance.~   "
4919|NCT03502525|"~     Break the Cycle is a two-session, one-on-one, in-person intervention study designed to reduce~     the role persons who inject drugs (PWID) play initiating non-PWID into injection drug use.~     Study implementation is at two sites: New York City and Tallinn, Estonia. At baseline,~     quantitative data are collected via a structured computer-assisted personal interview, after~     which the intervention is conducted. At the 6-month follow-up, a modified version of the~     interview is repeated. The study uses a pre- versus post- design to compare the proportion of~     participants who helped with first injections, and who promoted injecting among non-PWID, in~     the 6 months prior to baseline with the proportions at the 6-month follow-up. Based on~     previous research on the intervention and on the underlying theory of motivational~     interviewing, increases in helping and promoting behaviors between baseline and follow-up~     would indicate that the intervention was not effective regardless of their effect size.~     Accordingly, the hypotheses that the intervention will produce reductions in assisting with~     first injections and engaging in injection promoting behaviors will be evaluated using~     one-tailed statistical tests. Break the Cycle intervention follows a motivational~     interviewing approach to enhance current injectors' motivation and skills to avoid helping~     with and promoting first injections among non-PWID. The intervention's core is a discussion~     between an interventionist and each participant on the following eight topics: the~     participant's first time injecting drugs; the participant's exposures to situations where~     helping with others' first injections is an option, and the extent to which they have helped;~     PWIDs' behaviors that might encourage non-PWID to inject for the first time; the range of~     risks associated with injection drug use; role-playing scenarios in which the participant~     develops behaviors and scripts for avoiding or refusing requests to initiate others into~     injection drug use; role- playing talking with other PWID about not encouraging non-PWID to~     start injecting; imparting safer injection practices when helping with a first injection~     seems like the best option; and receiving training in and using Narcan to reverse overdoses.~   "
4920|NCT03502512|"~     During breast reconstructive surgery that uses autologous fat grafting (AFG, transplanting~     fat tissue from one part of participant's body to another), fat tissue is removed from the~     body (usually the abdomen, buttock, or thighs) and injected into another part of the body.~     This tissue must be processed (sometimes referred to as washed or prepared) before~     being inserted back into the body. In this study, 2 different types of tissue processing~     methods (REVOLVE and PureGraft) will be compared.~      The goal of this clinical research study is to collect data on the amount of fat that is~     absorbed by participant's body over time after surgery. Researchers also want to learn about~     the outcomes of any complications and overall patient satisfaction.~      This is an investigational study. The REVOLVE™ and PureGraft™ techniques are both FDA~     approved and commercially available.~      Up to 110 participants will be enrolled in this study. All will take part at MD Anderson.~   "
4921|NCT03502499|"~     The study evaluates the use of half-normal saline as an irrigant for open-irrigated catheters~     during left ventricular outflow tract ventricular arrhythmias ablation. By increasing the~     efficacy of radiofrequency energy-mediated lesion formation, half-normal saline has the~     potential to reduce procedural times and improved acute and long-term outcomes.~   "
4922|NCT03502486|"~     The study is a crossover randomised controlled trial. Alcohol or cocaine dependent~     participants will be recruited from inpatient and outpatient psychiatric treatment centres,~     on the approval of their treating physician. A healthy control group will be recruited using~     online advertising. All participants will undergo each of three conditions in a randomised~     order; 1) 20 minutes of cycle ergometry at 50-60% of maximum heart rate; 2) 20 minutes of~     exercise at 70-80% of maximum heart rate; 3) 20 minutes of quiet reading. Immediately before~     and after each condition, participants will be asked to complete a computerised Stroop test,~     watch a film containing substance-related images, and self-report craving levels. During the~     Stroop test and film viewing, participants' neural activity will be measured via functional~     near-infrared spectroscopy~   "
4923|NCT03502473|"~     Prospective, baseline-controlled evaluation of the UltraShape Power device for non-invasive~     fat reduction in flanks.~   "
5129|NCT03499743|"~     Many oral analgesic drugs such as the nonsteroidal anti-inflammatory drug (NSAID) are used to~     relieve pain from gynaecological procedures and dysmenorrhea. Hyoscine-N-butyl bromide, an~     antispasmodic drug is commonly used for relief of smooth muscle spasms and can be used to~     alleviate genito-urinary spasm. Some studies reported hyoscine couldn't relieve pain in minor~     gynaecological procedures. So the efficacy of Hyoscine-N-butyl bromide use is still~     controversial, and no previous studies investigated its effectiveness for pain relief in IUD~     insertion procedure.~   "
4924|NCT03502460|"~     The possibility of exploring the lungs by lung ultrasound, a non-invasive tool, is becoming~     increasingly popular for anesthesiologists. Recently, Lichtenstein has described the FALLS~     protocol (Fluid Administration Limited by Lung Sonography) which uses the potential of~     pulmonary ultrasound to evaluate early pulmonary overload due to fluid administration at a~     subclinical stage. Indeed, fluid administration can generate a sub-clinical interstitial~     syndrome that can be detected by passing from a profile A to a profile B in lung ultrasound.~     The transition from a profile A to a profile B therefore corresponds to the transition from a~     state of preload dependent to a state of preload independence. However, this tool has not~     been studied in the operating room. The main objective of this study will be to study the~     correlation between pulmonary ultrasound and SV variation measured by esophageal Doppler~     during fluid administration in patients with haemodynamic optimisation in the operating room~     during digestive, urological, gynecological and orthopedic surgeries. The main expected~     result is the following: good correlation between the absence of increased SV in the~     esophageal Doppler and the appearance of a B-profile lung ultrasound fluid administration in~     the operating room.~   "
4925|NCT03502447|"~     In this study, the TearCare System will be compared with standard-of-care warm compress~     treatment and lid massage in patients with dry eye disease. The objective is to demonstrate~     that the TearCare System is safe and effective in relieving the signs and symptoms of dry eye~     disease and that it is superior to a commonly prescribed, standard treatment of warm compress~     and lid massage.~   "
4926|NCT03502434|"~     This is a single center, randomized, controlled, within subject comparison, single dose study~     to determine the sensitization potential of SM04755 solution on normal skin under~     semi-occlusive patch conditions.~   "
4927|NCT03502421|"~     Sickle cell disease (SCD) often results in acute vaso-occlusive crisis (VOC), an obstruction~     of blood vessels resulting in ischemic injury and pain. The pain experienced during these~     episodes is due to a wide range of pathophysiological processes. Though recent studies have~     begun to unravel the underlying mechanisms of these processes, literature focused on pain~     management for sickle cell disease is scarce. Opioids and non-steroidal anti-inflammatory~     drugs (NSAIDs) remain the predominate treatment for VOC.~      However, the efficacy of these treatments has come into question. A large sub-set of patients~     with SCD report continued pain despite treatment with opioids. Tolerance and opioid-induced~     hyperalgesia (OIH) may be responsible for unresponsiveness to opioid-centric treatment~     modalities. New classes of drugs are being tested to prevent and treat acute pain associated~     with SCD, but in the meantime physicians are looking to existing therapies to bridge the gap.~      The N-methyl-d-aspartate (NMDA) receptor has been implicated in both tolerance and OIH. As a~     NMDA receptor agonist, ketamine has been shown to modulate opioid tolerance and OIH in animal~     models and clinical settings. Ketamine utilized as a low dose continuous infusion could~     benefit patients with SCD related pain that are unresponsive to opioid analgesics. Based on~     limited studies of adjuvant ketamine use for pain management, low-dose ketamine continuous~     infusion appears safe. Further clinical investigations are warranted to fully support the use~     of low-dose ketamine infusion in patients with SCD-related pain.~   "
4928|NCT03502408|"~     This study aims to evaluate the hypothesis that thrombectomy devices plus medical management~     leads to superior clinical outcomes in acute ischemic stroke patients at 90 days as compared~     to medical management alone in appropriately selected subjects with the Target Mismatch~     Profile and an MCA (M1 and M2 segment) or ICA occlusion or BA who have endovascular~     thrombectomy initiated between 6-24 hours after last seen well.~   "
4929|NCT03502395|"~     A prospective, double blinded and randomized study included women with breast cancer and~     underwent mastectomy, and randomly allocated into two groups of equal size. Lidocaine group~     and control group.~   "
4930|NCT03502382|"~     To What degree total knee replacement (TKA) affects leg length discrepancy in patients with~     varus deformity? Varus deformity, the most commonly encountered deformity in patients~     undergoing TKA is associated with limb alignment and varying degrees of contractures of~     medial soft tissue structures, laxity of the lateral soft tissue structures, flexion~     deformity and medial bone erosion at the knee joint .The challenges in performing TKA in a~     varus arthritic knee include restoration of limb alignment, balancing the medial and lateral~     soft tissue tension, equalizing flexion and extension gaps and restoring medial bone loss~   "
4931|NCT03502369|"~     The study evaluates the effectiveness of anterior quadratus lumborum block for post operative~     analgesia after hip arthroplasty. Half of the participants will receive ultrasound guided~     anterior quadratus lumborum block using 30ml bupivacaine 0.375%, while the other half will~     not receive the block ( control group).~   "
4932|NCT03502356|"~     The good standard antibiotic prophylaxis pre elective C S is cefazolin and this study will~     approve addition of azithromycin to cefazolin will reduce post CS infections more than~     cefazolin only.~   "
4933|NCT03502343|"~     Recently, a retrospective study reported the efficacy and safety of modified gemcitabine plus~     nab-paclitaxel (GnP), which were administered biweekly (on days 1 and 15). With 79 patients~     of metastatic pancreatic cancer, this study reported similar efficacy and improved toxicity~     profile compared with standard dose GnP (OS 10 months, PFS 5.4 months, Grade ≥3 Neutropenia~     19%, Grade ≥3 sensory neuropathy 1.6%). Also, several studies reported that dose reduction of~     nab-paclitaxel in breast or pancreatic cancer treatment was not related of decreased~     survival, or related with prolonged survival and increased treatment exposure. However, this~     finding need to be evaluated in prospective clinical trial.~      This phase II trial will evaluate the efficacy and safety of modified GnP, which omit the day~     8 administration of nab-paclitaxel, in metastatic pancreatic cancer.~   "
4934|NCT03502330|"~     This trial is a phase 1/1b study to evaluate the safety, efficacy, and tolerability of~     APX005M in combination with nivolumab and cabiralizumab.~      The phase 1 dose escalation portion of the study will enroll patients with advanced solid~     tumors melanoma, non-small cell lung cancer (NSCLC), and renal cell carcinoma (RCC) in 6~     cohorts to determine the recommended phase II dose (RP2D) of APX005M.~      The phase 1b dose expansion portion will study the triple drug combination separately in the~     three disease cohorts: melanoma, NSCLC, and RCC.~      Submitted on 3/29/2018; investigational new drug (IND) number is pending and will be added to~     the record once received.~   "
9730|NCT03439462|"~     A phase 1/2 multi-center investigation of ABI-009 (nab-rapamycin) in combination with~     mFOLFOX6 and Bevacizumab as first-line therapy in patients with advanced or metastatic~     colorectal cancer~   "
4935|NCT03502317|"~     This is a randomized control trial aiming to investigate the use of a prehabilitation regimen~     for patients undergoing major GI cancer surgery and its effects on measurements of HRQOL,~     LOS, and post-operative complications. Participants will be randomized to either the~     Prehabilitation arm or the Usual Care arm (control group). The Prehabilitation arm will be~     prescribed both physical and psychological prehabilitation prior to undergoing surgery for~     their GI cancer. The Usual Care arm will be counseled to continue their current level of~     activity and given the information on exercise as outlined in the Cancer Care Ontario~     guidelines. Participants in the Usual Care arm will also be given the same activity tracker~     as patients in the Prehabilitation arm in order to eliminate the activity tracker as an~     intervention itself. Clinical, patient-reported outcomes and health system outcomes will be~     evaluated. Outcomes will be measured at consent (baseline), immediately preoperatively, and~     postoperatively at 1, 3 and 6 months. The investigators will collect measures of recruitment,~     attrition and self-reported compliance via a log completed by the coordinator during weekly~     patient phone calls.~   "
4936|NCT03502304|"~     Despite exercise training decrease blood fasting glicaemy in 'average' terms, there is a wide~     inter-individual variability after exercise training explored mainly in adults but not in~     adults with prediabetes comorbidities. Thus, is yet unknown the effects and influence of the~     concurrent training (CT) eliciting responders (R) and non-responders (NR) cases (i.e.,~     percentage of subjects who experienced a non-change/worsened response after training in some~     metabolic outcomes).~   "
4937|NCT03502291|"~     The investigators are interested in examining the effect of the Live Attenuated Influenza~     (flu) Vaccine (LAIV) upon nasal carriage of bacteria called Streptococcus pneumoniae (also~     known as pneumococcus). The nasal spray is a live attenuated vaccine which means that it has~     weakened virus that does not cause disease. This vaccine is licenced in the United Kingdom~     for children and adolescents from 2 to 18 years of age.~      Pneumococcus can commonly be found harmlessly inhabiting the nose where it does not cause any~     problem (pneumococcal colonisation). About 10% of adults carry pneumococcus at any one time,~     and almost all adults experience an episode of carriage at least once per year. Carriage acts~     as a natural vaccine, boosting immunity against pneumococcal infection in adults and~     children.~      During influenza there is an increase in the burden of pneumococcal pneumonia. We have~     studied the effects of pneumococcus for many years and have developed a programme in which we~     can nasally inoculate healthy participants with a dose of pneumococcus and achieve a~     reproducible carriage rate. The investigators would now like to use this model to investigate~     the effects of the nasal influenza vaccine upon pneumococcal carriage and to better~     understand how influenza infections lead to increased susceptibility to pneumonia.~      Pneumococcal disease in young adults is rare - less than 10 cases per 100,000 people per~     year. When pneumococcus does cause problems, usually in young children or elderly people, it~     can be very serious as it is responsible for diseases such as pneumonia, sepsis and~     meningitis, which kill millions of children around the world each year.~   "
4938|NCT03502278|"~     This study will examine the initial efficacy and feasibility of a program called Islamic~     Trauma Healing by conducting a small RCT (N = 60) comparing Islamic Trauma Healing in an U.S.~     Somali refugee sample to a waitlist control on key targets of PTSD, depression, somatic~     symptoms, and quality of life. The hypothesis is that those in Islamic Trauma Healing will~     show a greater reduction of PTSD symptoms, depressive symptoms, and somatic symptoms and show~     a greater improvement in quality of well-being than those in the waitlist condition (WL).~   "
4939|NCT03502265|"~     Rationale. The Otteroo is a floatie which supports an infant or young child with their head~     above and their body in water. Researchers are proposing that the Otteroo may be a good~     tool to facilitate exploring the ability to move and control one's body before locomotion~     develops. Intervention. Otteroo will be used as an adjunct to standard care for 4 weeks.~   "
4940|NCT03502252|"~     The current trial focuses on the effectiveness evaluation of Semillas de Apego in Tumaco, a~     municipality in Colombia heavily affected by violence and poverty. Over a time-span of 23~     months, the researchers will follow the implementation of Semillas de Apego with 40 groups of~     16 participants each, all of them mothers or primary caregivers of children 2 to 5. This will~     allow the researchers to reach a total of 640 participants and their children. The impact~     evaluation will be based on a cluster- randomized control trial in which the researchers will~     assign 1280 eligible subjects, nested within 18 child development centers, to either an~     intervention arm or a control group. The former group will participate in 15 group-led~     session over the period of 3 months; the latter will continue to have access to the regular~     early childhood programs offered through the centers to which children are affiliated. Data~     will be collected at baseline and two follow-ups: 1 and 12 months after the implementation~     has concluded. The researchers hypothesize that the program will have a positive and~     sequential impact on the following dimensions: (i) primary caregiver's mental health, (ii)~     child rearing practices, (iii) quality of child-parent emotional bond, (iv) children's mental~     health, and (v) children's cognitive and socioemotional development.~   "
4941|NCT03502239|"~     Children with disorders that impact neurodevelopment often have difficulties with executive~     functions and regulating emotions. Cognitive-based video game training has been shown to~     improve outcomes, however, this training has been expensive, has required professional~     supervision, and has been investigated only within a narrow group of children. The Mega Team~     study will test the effects of a highly engaging, take-home video game-based intervention~     designed to improve executive functioning in children with various brain-based developmental~     disorders.~   "
4942|NCT03502226|"~     This is an exploratory pilot study to evaluate the feasibility and potential effects of an~     innovative, individualized electronic inpatient sexual health intervention (iRAP) for~     adolescent females. The central hypothesis is that the electronic intervention, a sexual~     health questionnaire with tailored feedback based on the Trans Theoretical Model (TTM) of~     behavior change, will significantly increase adolescent females' requests for sexually~     transmitted infection (STI) screening and sexual health management during their hospital~     admission.~   "
5130|NCT03499730|"~     To investigate whether midazolam has any effect on postoperative pain in outpatient surgery,~     the investigators will assess the impact of different midazolam doses on pain scores 24h, 7~     days and 3 months after open inguinal hernia repair.~      The investigators hypothesize that patients being administered higher midazolam doses will~     refer more pain.~   "
4943|NCT03502213|"~     Genomic Health's OncotypeDX® Prostate Cancer Assay is a commercially available laboratory~     test that measures the activity of certain genes in prostate cancer. The purpose of this~     study is to better understand how the use of this test result impacts or affects treatment~     decisions for men newly diagnosed with low risk prostate cancer, their confidence in the~     treatment decision, and the effects and side effects of the treatment chosen on certain~     aspects of Quality of Life. This study will also determine what percentage of men choosing an~     active monitoring program as prescribed by their doctor remain on Active Surveillance and~     have avoided any treatment at one and two years after diagnosis after receiving the assay~     result.~   "
4944|NCT03502187|"~     The overall objective of this project is to compare three home-managed treatment regimens for~     subacute low back pain: Progressive Exercise Plan (PEP), NMES (neuromuscular electrical~     stimulation) core strength training and standard primary care management (PCM). Each of the~     two treatment arms will be supplemented by Primary Care Management. The specific aim of the~     study is to determine whether the two treatment regimes are significantly more efficacious~     than standard PCM alone in improving lower back muscle strength, daily physical activity,~     physical function, quality of life and symptoms associated with subacute LBP.~   "
4945|NCT03502174|"~     This study is a non-randomized, single-arm, multi-center study that is designed to evaluate~     the safety and effectiveness of the FreeStyle Libre Flash Glucose Monitoring Systems in~     pediatric populations.~   "
4946|NCT03502161|"~     Validate the use of the device in the clinical setting for assessing the risk of CMV~     Infection in SOT recipients after the completion of antiviral prophylaxis.~   "
4947|NCT03502148|"~     Up to 31 subjects diagnosed with oral squamous cell carcinoma will receive one application of~     a permeation enhancer and 2, 3 or 5 treatment applications of a Cisplatin drug-loaded patch~     to the tumor site at each of 4 treatment visits. These 4 treatment visits will be scheduled~     to occur during the 3 weeks prior to the standard of care tumor resection.~   "
4948|NCT03502135|"~     Purpose:~      To evaluate anesthetic efficacy and overall patient experience with use of Kovanaze~     tetracaine/oxymetazoline nasal spray for root canal treatment of vital premolar and anterior~     teeth needing root canal treatment.~      Participants:~      30 adult patients with a vital upper anterior or premolar tooth (#4-13) with a diagnosis~     indicating need root canal treatment and who are seeking treatment in the UNC Chapel Hill~     School of Dentistry.~      Procedures (methods):~      Qualifying patients will be anesthetized with tetracaine/oxymetazoline nasal spray anesthetic~     in order to facilitate completion of their clinically required, standard of care root canal~     treatment. Research procedures include blood pressure monitoring and pain assessment using a~     visual analogue pain scale.~   "
4949|NCT03502122|"~     This study aims to design and verify a multi-mode smart assistive device system for Stroke~     Rehabilitation by using EEG, fMRI, IMU and questioners~   "
4950|NCT03502109|"~     Hypothesis: Medication Review with follow-up can improve clinical, health related quality of~     life and economic outcomes. To prove this hypothesis a cluster randomized controlled trial~     will be held in primary care centres of the public health system of Chile. Patients of the~     cardiovascular disease prevention program, older than 60 years and with poly pharmacy (more~     than 5 drugs) will be recruited. Control group will receive usual care and the intervention~     arm will have medication review consultations by a pharmacist every 2 months for one year.~     Clinical interventions will be made with physician authorisation. Participating pharmacist~     will be trained in cardiovascular prevention pharmacotherapy in the elderly, interview skills~     and educational techniques. A practice change facilitator will assist the pharmacist in any~     matters regarding the methodology and will asses barriers and facilitators to the~     implementation of the medication review with follow-up service. A personalised plan will be~     developed for every pharmacist. Clinical outcomes (blood pressure, HbA1c, LDL cholesterol,~     overall cardiovascular risk, among others), number of medications, adherence rate and health~     related quality of life will be evaluated. A cost-utility analysis will be made through the~     health ministry of Chile point of view.~   "
4951|NCT03502096|"~     This study investigated whether the provision of a to-go container influenced the portion~     size effect at a meal. Following a screening visit, women came to the lab once a week for 4~     weeks to eat a meal of multiple foods. At each visit, the portion size of the meal was varied~     in a counterbalanced order. Prior to their first meal, women were randomly assigned to one of~     two groups: a group that would have their leftovers packaged to go (to-go group) and a group~     that did not have leftovers packaged (control group). Women were instructed to eat ad libitum~     at the meals. They also answered questions about hunger and fullness as well as food~     characteristics before and after each meal. Following the final meal, subjects completed a~     series of questionnaires assessing subject characteristics as well as food characteristics.~     It was hypothesized that the effect of portion size on intake would be attenuated in subjects~     who received a to-go container with the meal. In addition, we aimed to identify any subject~     characteristics that moderated or exacerbated the portion size effect. It was also of~     interest to determine whether the portion size effect on individual foods were influenced by~     food characteristics such as perceived value.~   "
4952|NCT03502083|"~     Comprehensive assessment of human vasodilatory effect of GLP-1 in forearm and coronary~     arteries~   "
4953|NCT03502070|"~     The purpose of this study is to validate the user interface of TOBI Podhaler by establishing~     that the product can support safe and effective use for the intended users~   "
5008|NCT03501355|"~     It is well-known that not only peripheral muscles, but also respiratory muscles muscle~     weakness and deconditioning play an important role in low exercise capacity of patients with~     Heart Failure (HF). Exercise training has been shown to improve exercise tolerance and~     quality of life in patients with heart disease. However, hearth failure patients with~     pacemaker such as implantable cardioverter defibrillators (ICDs), cardiac resynchronization~     pacemakers or defibrillators (CRT-P or CRT-D) have additional specific issues when performing~     exercise. No study investigated the effects of different inspiratory muscle training~     protocols. For this reason, we aimed to investigate the effects of inspiratory muscle~     training on outcomes in hearth failure patients with pacemaker~   "
5131|NCT03499717|"~     The goal of our project is to evaluate the effectiveness of the Fall TIPS program with regard~     to inpatient falls and fall-related injuries.~   "
4954|NCT03502057|"~     Study Design: Prospective, single-blinded, multi-center, randomized, controlled, pivotal~     study Study Objective: To evaluate if P-15L is not inferior in effectiveness and safety to~     local autologous bone (and allograft as extender where necessary) when applied in~     instrumented TLIF in subjects with Degenerative disc disease (DDD)~      Study Endpoints:~      Primary endpoint: Month 24 Composite Clinical Success (CCS):~        -  Achievement of fusion (Evidence of continuous trabecular bridging bone in the~          intervertebral space)~        -  At least 15-point improvement in Oswestry Disability Index (ODI)~        -  No new or worsening, persistent neurological deficit~        -  No subsequent surgical intervention at the index level~      Once fusion is radiographically confirmed, it will be assumed that fusion has occurred at all~     subsequent time points without the need to reconfirm fusion status at later time points.~      Multiplicity Controlled Secondary endpoint:~      • Visit at which fusion is confirmed.~      Other Secondary endpoints:~        -  Visual Analog Scale (VAS) pain scores, changes over time, and achievement of a 20 mm~          improvement (Back, left leg, right leg);~        -  Physical Function and Mental Health Composite Scores (Short Form Health Survey SF-12 and~          changes over time).~   "
4955|NCT03502044|"~     Placebo controlled trial study of efficacy of Kinetic Oscillation Stimulation (KOS) in nasal~     cavity will be conducted in patients with myalgic Encephalomyelitis/Chronic Fatigue Syndrome~     (ME/CFS). The outcome of the treatment will be assessed with clinical evaluation of patients,~     cognitive tests, structural and functional MRI of the brain.~   "
4956|NCT03502031|"~     The objective is to determine in a cost-effective manner; the safety and efficacy of~     standard of care renin-angiotensin-aldosterone System (RAAS) alone or in combination with a~     fixed dose of Spironolactone (25 mg) on eGFR (epidermal growth factor receptor) and~     proteinuria in African Americans with type II diabetes and diabetic nephropathy.~   "
4957|NCT03502018|"~     This study will examine the efficacy of Liposomal Bupivacaine (Exparel) in hip fracture~     patients undergoing hip hemiarthroplasty for femoral neck fractures through a posterior~     approach. Post-operative measures will be assessing pain, overall opiate use, delirium,~     time-to-ambulation and discharge status.~   "
4958|NCT03502005|"~     This study evaluates the efficacy, safety and tolerability of switching from the older,~     established single tablet regimen of ATRIPLA® (EFV/FTC/TDF) to a new single tablet regimen of~     BIKTARVY® (BIC/FTC/TAF), in HIV-1 infected adult subjects who are virologically suppressed~     (HIV-1 RNA<50 copies/mL).~   "
4959|NCT03501992|"~     Each year the human papillomavirus (HPV) causes 30,000 cancers in the United States despite~     the availability of very effective and safe vaccines. Uptake of the HPV vaccine has been~     disappointingly low and lags behind other adolescent vaccines. This study seeks to test~     interventions targeting health care system, provider, and patient factors to improve the~     population uptake of the HPV vaccine.~   "
4960|NCT03501979|"~     A phase 2 non-randomized study to assess the safety and efficacy of the combination of~     tucatinib and trastuzumab with capecitabine for the treatment of leptomeningeal metastases in~     HER2-neu positive breast cancer.~   "
4961|NCT03501966|"~     Randomized trial of adults (≥18 years old) with idiopathic intracranial hypertension and~     moderate to severe visual loss without substantial recent treatment who are randomly assigned~     to (1) medical therapy, (2) medical therapy plus ONSF, or (3) medical therapy plus VPS. The~     primary outcome is visual field mean deviation change at first of Month 6 (26 weeks) or time~     of treatment failure of the eligible eye(s), followed by a continuation study to assess time~     to treatment failure. The determination of eligible eye(s) is based on meeting the~     eligibility criteria at baseline.~   "
4962|NCT03501953|"~     This randomized intervention is designed to compare the influence of physical activity in~     natural and urban environments on cognitive and physical health. Half of the participants~     will participate in a six-week physical activity class based in a natural environment, and~     half of the participants will participate in a six-week physical activity class based in an~     indoor environment. The investigators hypothesize the nature-based intervention will produce~     lower cognitive fatigue (measured using neurophysiological measurements), better cognitive~     performance (measured using cognitive assessments), and increased physical fitness (measuring~     using fitness testing).~   "
4963|NCT03501940|"~     This phase II trial studies how well fluorine F 18 DCFPyL positron emission~     tomography/computed tomography (PET/CT) works in imaging participants with prostate cancer~     that has come back. Diagnostic procedures, such as fluorine F 18 DCFPyL PET/CT, may help find~     and diagnose prostate cancer and find out how far the disease has spread.~   "
4964|NCT03501927|"~     Mortality and morbidity remain high after non-cardiac surgery. Known risk factors include~     age, high ASA grade and emergency surgery. Point-of-care focused cardiac ultrasound may~     elucidate pathology and potential hemodynamic compromise unknown to handling physicians. This~     study aims to investigate the effects of focused cardiac ultrasound in high-risk patients~     undergoing non-cardiac surgery with respect to clinical endpoints.~   "
4965|NCT03501914|"~     The proposed study is a pre-post intervention study to investigate the acceptability and~     feasibility of a mindfulness based program for people with intellectual disabilities and~     their caregivers in a low income setting in Pakistan.~   "
4966|NCT03501901|"~     The aim of this study was to compare the etiologic agents, the antimicrobial resistance~     rates, and the risk factors associated with a HA-UTI and CA-UTI among complicated and~     uncomplicated UTI patients in a tertiary-care hospital in Mexico. This study was performed~     according to the principles expressed in the Declaration of Helsinki with the approval of the~     Local Ethics Committee of the School of Medicine of the Universidad Autónoma de Nuevo León~     (UR14-004). All patients with a UTI and a positive urine culture (> 100,000 UFC/mL) from~     March to October 2015 were included. The study was carried out at the Hospital Universitario~     Dr. José Eleuterio González hospital, a tertiary-care teaching hospital in Monterrey,~     Mexico. Identification and susceptibility antibiotic assays were performed to all isolates~     from positive urine culture.~   "
4967|NCT03501888|"~     Patients with psychoses are randomized either to group treatment (ACT) or individual CBT for~     18 sessions.~   "
5132|NCT03499704|"~     The purpose of this study is to compare the efficacy of pioglitazone plus alogliptin plus~     metformin with glimepiride plus alogliptin plus metformin on glycosylated haemoglobin (HbA1c)~     change from baseline to Week 26.~   "
4968|NCT03501875|"~     Familial hypercholesterolemia (FH) is an autosomal dominant genetic disorder characterized by~     elevated plasma levels of LDL-C cholesterol. This early and significant elevation of LDL-C~     triggers premature atherosclerosis, particularly coronary artery disease.~      The initiation and management of LDL-C therapies is based on cardiovascular risk assessment.~     Although this is undoubtedly higher than in normocholesterolemic patients, a significant~     heterogeneity in heFH patients still persists that is not completely explained. Moreover, the~     evaluation of cardiovascular risk in patients with heFH is difficult for many reasons:~     non-validity of risk scores, futility of a risk calculation limited to 10 years in a young~     patient, late positivity of stress tests .~      Therefore, there is a clear need for new cardiovascular risk assessment tools to identify~     higher risk heFH patients who could benefit from early and aggressive treatment.~      The Coronary Artery Calcium (CAC) Score has been widely studied in the US and validated in~     European recommendations, and has shown the best reclassification index for patients at~     intermediate cardiovascular risk. A CAC score of zero is associated with a very low risk of~     event irrespective of the number of risk factors.~      Non-calcified plaques are by definition not detected by ACC and patients with CAC = 0 may~     only have soft non-calcified plaques. The prevalence of these non-calcified plaques in very~     high-risk patients with acute coronary syndrome is 5%. The prevalence in FH patients is~     unknown. It has also been shown that the extent of the atherosclerotic burden is related to~     cardiovascular risk.~      CAC score has been poorly evaluated in heFH patients. However, hypercholesterolemia and~     calcifications have been shown to be correlated: supra-aortic calcified masses in homozygous~     FH patients, early calcifications associated with chronic exposure to high LDL-C (cholesterol~     burden, equivalent to cigarettes) and finally, the calcifying role of statins.~      The early increase of LDL-C in patients with genetic forms of FH causes premature~     cardiovascular damage. Investigators' hypothesis is that patients with FH have earlier~     coronary atheroma (and thus calcifications and non-calcified plaques) due to exposure early~     in life to high levels of LDL-cholesterol.~   "
4969|NCT03501862|"~     People with schizophrenia demonstrated a tendency to use maladaptive cognitive emotion~     regulation strategies as compared with healthy control groups.~      The present study is the first randomized controlled trial of group mindfulness-based~     intervention for psychosis. Half group will join the mindfulness-based cognitive intervention~     while another half will participate in psychoeducation to examine whether mindfulness will~     have a positive impact on emotion regulation and distress.~   "
4970|NCT03501849|"~     During colonoscopy, the endoscopist will document prospectively all polyps detected and note~     the size, location and morphology. Polyps of 4-20 mm will be removed only in accordance with~     the method the cold snare. Afterwards, the remaining tissues will be observed with an imaging~     technology called Optivista with an injection of 10-50 ml of saline solution (if required) to~     improve visibility of the tissues. The intestinal mucosa will be carefully examined using~     Optivista imaging and the endoscopist will continue to remove the remaining polyp tissue~     (with a snare or forceps) until there are no more visible polyp tissues. Biopsies from the~     polyp resection site will be sent to the laboratory for analysis to confirm the complete~     resection.~   "
4971|NCT03501836|"~     This study is designed to compare the performance of both 6 and 10 electrode ECGs from the~     handheld device with the conventional 12 lead ECG. As well as comparing the detection of~     atrial fibrillation, the study will also compare the detection of other heart problems and of~     normal heart rhythm.~   "
4972|NCT03501823|"~     Cancer is one of the leading causes of death internationally. When planning treatment for~     most cancers, it is important to know how far it has spread, including whether or not the~     cancer has spread to the local lymph nodes (LNs) because this affects the treatment strategy.~     This is termed staging, and can be achieved by medical imaging, such as by ultrasound,~     computed tomography (CT) or magnetic resonance imaging (MRI) scans. However, these are~     imperfect, and sometimes incorrect treatment decisions are made because of errors in staging~     by imaging. Improved accuracy would be of great clinical value for almost all solid organ~     tumours. An emerging technique to address this is photoacoustic tomography (PAT), a~     non-invasive, safe modality that relies on light and sound to generate images. Laser light is~     applied to the area to be imaged; this is absorbed, and causes the illuminated tissue to emit~     ultrasound waves. These can be detected and turned into an image by post-processing~     techniques similar to those used in conventional diagnostic ultrasound. By changing the~     wavelength of light used, the technique can be adjusted to optimise detection of various body~     components, including fat, water and both oxygenated and deoxygenated blood. This means the~     images can represent tissue composition and function rather than just anatomical structure.~     Hitherto, most work on PAT has been on healthy volunteers, and has focused on imaging the~     vasculature. We would like to see whether we are able to generate images of deeper structures~     inside the body. Initially we will focus on patients with vascular disease, whom we expect to~     have abnormal blood vessels; and subsequently we will attempt to image tumours and LNs in~     patients with cancer.~   "
4973|NCT03501810|"~     Study to Assess the Safety and Performance of the OrtoWell® Distractor in Patients Undergoing~     Spinal Surgery~   "
4974|NCT03501797|"~     This study evaluates the verbal, cognitive, emotional, and neural efficacy of a choir singing~     intervention in chronic aphasic patients and their caregivers. Using a cross-over RCT design,~     half of the participants receive a 4-month singing intervention during the first half of the~     study and half of the participants during the second half of the study.~   "
4975|NCT03501784|"~     The study purpose is to evaluate the antimicrobial effect of Nobio particles incorporated~     within Novidia Dental Bonding and Flowable Composite versus standard of care within a split~     mouth model.The study population will include 35 subjects considered to be at high risk for~     cervical caries and affected by uncontrolled plaque accumulation~   "
4976|NCT03501771|"~     Introduction: In TCM, Pulse Diagnosis has been one of the key diagnostic components in the~     clinical examinations. Traditionally, the palpation of the pulse on the radial artery is~     subjective among the physicians. With the development of the various devices to study the~     radial pressure pulse wave (RPPW), these have provided a scientific and objective assessment~     to assist the physicians on diagnosis and treatment. The primary objective of this~     intervention study is to investigate the effects of Acupuncture on the RPPW at cunkou in Low~     Back Pain (LBP) through the pulse sphygmograph. The secondary objective is to investigate the~     effect of acupoint combinations on different type LBP based on TCM syndrome differentiation~     through the primary and secondary outcome evaluations.~      Methods: A single group, pre-post intervention study in which all participants receiving the~     same intervention will be conducted. A total 80 participants that meet all the following~     criteria will be enrolled: a. at least 20 years of age of either gender; b. chief complaint~     being low back pain; c. diagnosis with Lumbago (ICD-9-CM 724.2) or low back pain: loin pain,~     low back strain and lumbago NOS (not otherwise specified) (ICD-10-CM M54.4); d. diagnosis~     with lumbago with sciatica (ICD-10-CM M54.5). All participants will undergo acupuncture at~     BI23, BI25 & Bl40 after obtaining written informed consent. Objective and subjective baseline~     assessments and outcome evaluations including Vital Signs, health status questionnaire,~     Constitution in Chinese Medicines Questionnaire (CCMQ), Oswestry Disability Index, Faces Pain~     Scale-Revised (FPS-R) will be performed. The primary outcome will be the assessment of RPPW~     at cunkou ie at Cun, Guan & Chi of both hands using Pulse Sphygmograph before and after the~     intervention. The secondary outcome involves evaluating low back pain using the~     Fingertips-to-floor test & FPS-R before and after the intervention.~      Expected Outcome: The results will be analyzed and provide information which can serve as~     clinical evidence of the influence of acupuncture on the RPPW at cunkou. In addition, the~     effectiveness of the acupoint combinations on the different type of LBP based on TCM syndrome~     differentiation can be further investigated.~   "
9731|NCT03439449|"~     The aim is to determine the additional value of computerized, patient-entered medical~     histories for the management of patients presenting at the emergency department with chest~     pain.~   "
4977|NCT03501758|"~     Rationale:~      Ulcerative colitis (UC) is remitting disease with a variable course. Predicting disease~     relapse after remission is important for the adjustment of medical treatment. Ileocolonoscopy~     is the best tool for doing this, but due to its invasiveness should be replaced by a method~     better accepted by the patient. Gastrointestinal ultrasound (GIUS) could be such a method.The~     PRELAPSE study will include UC patients who have been on maintenance anti-TNF therapy for at~     one year or more and in clinical remission for the 3 past months at least in two centres,~     Haukeland University Hospital and Ålesund Hospital. The infrastructure for recruiting these~     patients has already been established in the BIOSTOP study (Protocol ID no: HMR2016-0.6 and~     EudraCT (European Clinical Trials Database) no: 2016-001409-18).~      Objective:~      To study if GIUS or individual US parameters can predict endoscopic relapse at follow up~     examinations in a group of patients with ulcerative colitis in sustained clinical and~     endoscopic remission~      Study design:~      Prospective, longitudinal, explorative, observational multi-centric study for diagnostic~     accuracy Study population: Adult patients with histo-pathologically confirmed diagnosis of UC~     between 18 and 80 years of age that have entered the BIOSTOP trial (Trial number: EudraCT:~     2016-001409-18) will be considered for inclusion in the proposed study.~      Intervention:~      All patients will be subjected to trans-abdominal gastrointestinal ultrasound and~     ileocolonoscopy. Blood and faeces samples will be collected at one time point for measuring~     relevant inflammatory markers.~      Main study parameter: Ultrasound measurements of the intestine of patients with ulcerative~     colitis Nature and extent of the burden and risks associated with participation, benefit and~     group relatedness: All patients will be examined repeatedly with gastrointestinal ultrasound~     (GIUS) and at certain time points with ileocolonoscopy or sigmoidoscopy. As all these~     procedures already are scheduled as a part of the BIOSTOP study the only extra burden for the~     patients will be the ultrasound examination. GIUS is a safe procedure that uses high~     frequency sound waves for the visualization of internal organs. The implementation of GIUS~     for the assessment of disease activity in UC patients might result in a reduced need for~     ileocolonoscopy, thereby reducing costs and the burden for patients. Compared to invasive~     endoscopic procedures GIUS can be performed without preparation, which is an advantage for~     the patients as treatment decisions can be made without delay. GIUS is also cheaper than~     ileocolonoscopy, causes little discomfort and has few or no complications.~   "
4978|NCT03501745|"~     Through remote management and propaganda of intelligent mobile phone, the standard rate of~     blood pressure control and the change of renal function were observed.~   "
4979|NCT03501732|"~     A key component of effective offender treatment is an initial assessment of risk factors~     followed by feedback to facilitate problem awareness and engagement in appropriate treatment~     and/or behavior change. Feedback regarding areas of high risk, however, can be experienced as~     threatening.~      The investigators propose to develop, fine-tune, and pilot-test a computerized system for~     risk assessment and feedback, including evaluation of a brief pre-feedback prosocial values~     affirmation exercise (Cohen & Sherman, 2014) aimed at decreasing defensiveness and increasing~     inmates' willingness to access and process risk-relevant information and to utilize~     post-release treatment resources, thereby reducing post-release substance misuse, HIV risk~     behavior, and criminal recidivism. Participants will be 170 jail inmates nearing release into~     the community - 20 pilot participants and 150 study participants randomly assigned to one of~     three conditions: (1) Values Affirmation + Personalized Risk Feedback; (2) Personalized Risk~     Feedback only; (3) Control. The baseline and risk assessment, values affirmation~     manipulation, and personalized risk feedback will be presented via touch-screen computers,~     requiring minimal training to administer. Analyses will assess:~        1. The feasibility of utilizing a computerized system to assess and share risk information~          with jail inmates, including a brief values affirmation exercise to reduce~          defensiveness;~        2. The acceptability of this approach from the perspectives of jail staff and inmates~          themselves;~        3. The impact of the intervention on observed proximal outcomes (mechanisms of action),~          such as time spent viewing feedback, electing to print a copy of informational and~          treatment resources, and consequent changes in perceptions of risk, treatability, etc.;~        4. The impact of the intervention on key post-release outcomes including engagement in~          relevant treatment services, substance misuse, HIV risk behaviors, re-offense and~          re-arrest;~        5. The links between proximal outcomes (MOAs) and key post-release outcomes;~        6. Potential moderators of treatment effectiveness.~   "
4980|NCT03501719|"~     The effects of the number of drugs included in antiretroviral therapy (ART) regimens of~     inflammatory markers remains undefined. We will evaluated in participants in the Spanish AIDS~     Research Network, whether triple ART, dual ART or monotherapy affect differentially the~     dynamics of inflammatory markers.~   "
4981|NCT03501706|"~     Many health-relevant decisions involve intertemporal (now vs. later) tradeoffs. Extensive~     literature indicates that many negative health and financial consequences suffered in~     mid-life are linked to adversity and disadvantage during early developmental periods of life.~     Individuals who continue to engage in these types of unhealthy behaviors despite awareness of~     the health consequences are exhibiting an inability to delay gratification.~      Delay discounting (DD) is quantified in human studies by determining the rate at which an~     individual discounts a delayed reward, while executive function (EF) is defined as the set of~     cognitive processes that are responsible for helping individuals manage life tasks and~     achieve goals. This research will attempt to reduce DD via EF training in a population of~     mid-life individuals with risk factors established during early-life disadvantage.~   "
4982|NCT03501693|"~     The purpose of the pivotal reader study is to assess the comparative accuracy of Fujifilm DBT~     plus S-View versus FFDM in the detection of breast cancer.~   "
4983|NCT03501680|"~     The aim of this study is to investigate the therapeutic efficacy of intensive insulin in~     patients with hypertriglyceridemia induced moderate/severe acute pancreatitis on the course~     and outcome of disease.~   "
4984|NCT03501667|"~     Boston Children's Hospital resources include SimulConsult which is a decision support tool~     available for use of BCH provider through the library portal. It is offered along other~     resources on that webpage (UpToDate, Micromedex, and VisualDx). See addendum 1.~      Recently, a pediatric rheumatology arm was added to the expertise of SimulConsult, guided by~     our co-PI, Dr. Robert Sundel. As this tool is being offered and used, the investigators would~     like to assess metric of performance of this tool in enhancing participant trainees knowledge~     about the work up of patients with a potential rheumatologic disorder. See also~     www.ncbi.nlm.gov/pubmed/27964737 The investigators are conducting a clinical research to~     assess improvement in the clinical performance of study participants evaluating patients with~     a potential rheumatologic disorder. The intervention involved in using a computerized~     decision support tool already available in the Boston Children's Hospital domain. The outcome~     will be comparing this performance to that of an attending physician as the gold standard. We~     will assess the study participants performance across two locations: Emergency Department and~     Rheumatology clinic. Care to patients remains unchanged, as the workup plan and care is~     provided by an attending across both domains.~      The investigators main hypothesis is that using a decision support tool will result in a~     higher agreement rate between study participants' differential diagnosis and work up plan~     compared with the gold standard (attending differential diagnosis and research plan).~   "
4985|NCT03501654|"~     This is to evaluate the satisfaction of patient and physician about short-distance,~     medium-distance, long-distance postoperative vision and eyeglass dependence, glare, and~     visual acuity after insertion of the TECNIS® Symfony or TECNIS® Symfony Toric intraocular~     lens.~   "
4986|NCT03501641|"~     This study aims to compare heart rate variation, cognitive load, and learning outcomes of~     novel image-based virtual reality with traditional video in learning for otolaryngology. Half~     of participants will receive image-based virtual reality learning, while the other half will~     receive video-based learning.~   "
4987|NCT03501628|"~     The purpose of this study was to determine the effects of L-leucine (LEU) or different~     protein supplements standardized to LEU (~3.0 g/serving) on changes in body composition,~     strength, and histological attributes in skeletal muscle and adipose tissue. Seventy-five~     untrained, college-aged males (mean±SE; age=21±1 yr, body mass=79.2±0.3 kg) were randomly~     assigned to an isocaloric, lipid-, and organoleptically-matched maltodextrin placebo (PLA,~     n=15), LEU (n=14), whey protein concentrate (WPC, n=17), whey protein hydrolysate (WPH,~     n=14), or soy protein concentrate (SPC, n=15) group. Participants performed whole-body~     resistance training three days per week for 12 weeks while consuming supplements twice daily.~     Skeletal muscle and subcutaneous (SQ) fat biopsies were obtained at baseline (T1) and ~72 h~     following the last day of training (T39). Tissue samples were analyzed for changes in type I~     and II fiber cross sectional area (CSA), non-fiber specific satellite cell count, and SQ~     adipocyte CSA. On average, all supplement groups including PLA exhibited similar training~     volumes and experienced statistically similar increases in total body skeletal muscle mass~     determined by dual x-ray absorptiometry (+2.2 kg; time p=0.024) and type I and II fiber CSA~     increases (+394 µm2 and +927 µm2; time p<0.001 and 0.024, respectively). Notably, all groups~     reported increasing Calorie intakes ~600-800 kcal/d from T1 to T39 (time p<0.001), and all~     groups consumed at least 1.1 g/kg/d of protein at T1 and 1.3 g/kg/d at T39. There was a~     training, but no supplementation, effect regarding the reduction in SQ adipocyte CSA (-210~     µm2; time p=0.001). Interestingly, satellite cell counts within the WPC (p<0.05) and WPH~     (p<0.05) groups were greater at T39 relative to T1. In summary, LEU or protein~     supplementation (standardized to LEU content) does not provide added benefit in increasing~     whole-body skeletal muscle mass or strength above PLA following 3 months of training in~     previously untrained college-aged males that increase Calorie intakes with resistance~     training and consume above the recommended daily intake of protein throughout training.~     However, whey protein supplementation increases skeletal muscle satellite cell number in this~     population, and this phenomena may promote more favorable training adaptations over more~     prolonged periods.~   "
4988|NCT03501615|"~     Early Access Programme to provide treatment access to moxetumomab pasudotox for eligible~     patients with relapsed/refractory hairy cell leukemia~   "
4989|NCT03501602|"~     Investigators aimed to compare the ease of use of the LMA protector and I-gel LMA for~     tracheal intubation with the Aintree catheter in our study.~      Laryngeal mask airway (LMA) protector is the second generation perilaryngeal seal type~     supraglottic airway tool. The I-gel LMA is the second generation uncuffed supraglottic airway~     device. The Aintree Intubation Catheter has been designed for assisted fiberoptic intubation~     and for uncomplicated, atraumatic endotracheal tube exchange.Both LMA types have a structure~     that permits endotracheal intubation. In cases of difficult intubation, these two LMA types~     can be used. In the literature, there is no study comparing these two LMA types using Aintree~     catheter.Difficult Airway Society (DAS) published a guide for tracheal intubation in 2011~     using Aintree. According to this guide, LMA type LMA Supreme is the most unfavorable for this~     process. However, there is no research or recommendation on the type of LMA most suitable for~     use in the literature. In accordance with the data of this study, it will be tried to show~     which LMA type may be suitable for intubation with Aintree catheter in patients.~   "
4990|NCT03501589|"~     The researchers are trying to identify molecular mechanisms that control growth plate~     mediated limb growth and identify agents that can be used to enhance or slow growth.~   "
4991|NCT03501576|"~     This clinical trial evaluates the influenza virus vaccination in evaluating human immune~     response in patients with lymphoma. Evaluating immune response may increase the understanding~     of how the immune system changes when patients receive treatment for lymphomas by looking at~     the antibody levels and the level of the different cells that make up the immune system over~     time compared to those without lymphoma.~   "
4992|NCT03501563|"~     Oxidative stress at the cellular level and the effects of the antioxidant system on the~     anesthetic drugs make the anesthesia method more important. Hypotensive anesthesia or~     controlled hypotension is an anesthetic technique routinely used in many operations (ENT,~     orthopedic, plastic surgery, etc.) to reduce intraoperative bleeding and to provide a more~     open surgical area.~      In this study, investigators aimed to investigate the effects of hypotensive anesthesia on~     thiol / disulfide balance from oxidative stress markers.~      Hypotensive anesthesia is caused by hypoperfusion and hypoxia-induced oxidative stresses at~     the tissue level and can initiate cell damage. Many methods can be used alone or in~     combination to create hypotensive anesthesia. İnvestigators will investigate whether~     hypotensive anesthesia causes an effect on the cellular level.~   "
4993|NCT03501550|"~     Open label phase 2a study of two week treatment with CDI-31244 and sofosbuvir and veltapasvir~     followed by four week treatment of sofosbuvir and velpatasvir in individuals with chronic~     hepatitis C (HCV) genotype 1 (GT1) infection~   "
4994|NCT03501537|"~     Lack of keratinised mucosa around dental implants and teeth is associated with plaque~     accumulation and worse tissue conditions. However, there is lack of data on the influence of~     the presence/lack of keratinised mucosa on the periodontal condition. Hence, soft tissue~     conditioning by grafting with a gingival graft is aimed at improving the quality of the~     peri-implant conditions~   "
4995|NCT03501524|"~     This is prospective, randomized study comparing VATS (video- Assisted Thoracoscopy) to~     reinsertion of a thoracostomy tube in patients with persistent traumatic haemothorax. The~     incidence varies and can be as high as 20%, but in most studies is found to be 1-4% after~     initial tube thoracostomy for chest trauma. The most accepted complication of retained~     hemothorax is empyema.Retained hemothorax treatment started by physiotherapy and early~     withdrawal of tube thoracostomy which lead to more complications as empyema, fibro~     thorax/entrapped lung, flail chest and diaphragmatic hernia. Early VATS is an alternative~     treatment for retained hemothorax with evidence that it is a superior intervention when~     compared to a second tube thoracostomy.~   "
4996|NCT03501511|"~     Adult Muslims are obliged to start fasting during the month of Ramadan. Fasting entails~     refraining from all food, drink, tablets and injections(vitamins & fluids) between sunrise~     and sunset; a period which varies by geographical location and season.~      People with type 1 Diabetes are among those who are risky to fast this holy month in the~     Muslim faith and thus are exempted from fasting. Yet many patients fast in spite of medical~     advice and religious exemption and for those patients, healthcare professionals should~     provide the utmost care and continuous diabetes education.~      Different diabetes education modalities exist like DSME (Diabetes self-management education~     with proven efficacy. One modality is the Diabetes Conversation Map which delivers diabetes~     education interactively through a series of maps that address different issues in diabetes~     management and includes a specially designed Ramadan map.~      In this study, two modalities of Diabetes focused Ramadan education will be compared~     regarding aiding patients to fast Ramadan safely. One modality will be Diabetes conversation~     maps and the other the International Diabetes Federation Education modules.~   "
4997|NCT03501498|"~     A study to determine the influence of changing intestinal transit time of the enterohepatic~     recirculation of bile acids.~   "
4998|NCT03501485|"~     Resting Energy Expenditure is the amount of energy, usually expressed in Kcal required for a~     24 hour period by the body during resting conditions. It is closely related to, but not~     identical to, basal metabolic rate.~      According to the ESPGHAN committee guidelines on enteral nutrient supply for preterm infants,~     which were published in 2010, the daily protein intake of extremely low birth weight infants~     shall be 4.5 g/kg/day, and for those above 1000g, 4 g/kg/day. In order to meet these~     recommendations, the human milk for all premature infants is enriched with human milk~     fortifier, and supplemental liquid protein according to our NICU protocol.~      Little is known on the effect of this enrichment on the basal metabolic rate of premature~     infants.~      One way of determining the basal metabolic rate is by measuring the resting energy~     expenditure. In order to do that the investigators use an indirect calorimety by using the~     Deltatrac II metabolic monitor (Datex-Ohmeda). This instrument uses the principle of the~     open-circuit system that allows continuous measurements of oxygen consumption and carbon~     dioxide production using a constant flow generator.~   "
4999|NCT03501472|"~     Pictorial cigarette warning labels (PWLs) are thought to increase risk knowledge, but~     experimental research has not examined PWLs' longer term effects on memory for health risks,~     or for numeric risks (e.g., percentage risk for developing lung cancer). This trial tests~     memory for numeric health risks immediately or after a six-week delay for US adult smokers.~     In addition, the trial tests the effects of different warning label components (e.g., whether~     the numeric risks are percentage or frequency), participants' level of numeric ability, and~     the consequences of memory for numeric risks on participant risk perceptions and quit~     intentions.~   "
5000|NCT03501459|"~     The purpose of this study is to investigate if lymphocyte markers predict response to~     rituximab among patients with idiopathic nephrotic syndrome~   "
5001|NCT03501446|"~     The capnodynamic method non-invasively calculates effective lung volume (ELV) continuously~     during surgery. In this study ELV is compared to functionalresidual capacity (FRC) measured~     with Nitrogen Multiple Breath Wash out (NMBW) at 0 and 5 cm H2O Positive End Expiratory~     Pressure (PEEP) in patients scheduled for neck surgery at the Karolinska University Hospital,~     Solna, Sweden.~   "
5002|NCT03501433|"~     The purpose of this study is to determine the effects of Nicotinamide Riboside (NR)~     supplementation on metabolism and vascular function following high-fat meal. Differences~     between young (18-35) and older (60-75) adults will be determined.~   "
5003|NCT03501420|"~     Sjogren's Syndrome is a chronic autoimmune disease characterized by sicca (dryness) symptoms~     of the mouth and eyes. This autoimmune disease is less commonly studied and there are no~     licensed treatments to treat the underlying cause of disease and current management is based~     on clinical experience and/or small clinical studies. This study is based on DSP methodology,~     a multinational, cross-sectional, multi-sponsor survey of robust real-world data. DSP~     methodology collects quantitative market research data. The pSS DSP will survey a sample of~     approximately 230 to 325 rheumatologists and their prospectively consulting pSS subjects in~     France, Germany, Italy, Spain and the US. The data will be collected via physician~     interviews, physician workload questionnaires, detailed patient record forms (PRFs) to be~     completed by physicians, and a self-completion questionnaire by pSS subjects. The data~     collected using this method includes subjective and objective evidence, clinical information~     about individual patients, their disease and their treatment. This DSP will follow three key~     phases: preparatory phase, data collection phase and data processing/analysis phase.~   "
5004|NCT03501407|"~     Ticks are the major arthropod vectors transmitting pathogenic agents to humans and domestic~     animals in Europe, and currently, the incidence of tick-borne disease is rising. The most~     common European human tick-borne disease is Lyme borreliosis, with an estimated 90 000 new~     cases every year (compared to 300 000 new cases in the United States annually). This disease~     is initially clinically diagnosed by the presence of migrating erythema following a tick~     bite, which is then subsequently confirmed by serological tests. In parallel with classic~     Lyme borreliosis cases, tick-bitten patients can also present with polymorphic and~     on-specific clinical symptoms (asthenia, fever, myalgia, etc. …) for which there is no known~     etiological diagnosis. It is extremely difficult to determine the proportion of tick-bitten~     patients with these symptoms compared to patients which have actually contracted Lyme~     disease, although it is estimated that 50% of fevers following a tick bite have an unknown~     infectious origin.~      Typical tick habitats are woodlands, prairies, pastures, and gardens. Ticks are extremely~     sensitive to environmental fluctuations, which are often brought about by human~     socio-economic changes, thus tick-borne diseases are excellent candidates for emergence.~     Consequently, it is incontestable that tickborne diseases pose a significant threat to our~     society. In addition to improving diagnostic techniques, one of the major hurdles relates to~     improving public and health professional knowledge about tick disease risk. The battle~     against tick-borne diseases is based on relatively simple prevention measures, and their~     effectiveness is immeasurably improved when citizens are more informed and~     involved.Therefore, a multidisciplinary project, bringing together veterinarians, doctors,~     scientists, and consultant sociologists has been designed to create a global One Health~     approach to tick-borne diseases. Specific scientific project objectives are to (1) detect,~     identify, and isolate new microorganisms—both unknown or unexpected—from patients or animals~     suffering from unexplainable symptoms following tick bites; (2) to demonstrate tick~     competence in their ability to transmit these agents; and (3) to generate concrete~     recommendations to improve tick-borne disease management.~   "
5005|NCT03501394|"~     Breast cancer is the most prevalent cancer affecting women. To treat locally advanced breast~     cancers, neoadjuvant chemotherapy (NACT) is often carried out before surgery to reduce the~     tumour size to allow breast conservation surgery. However, treatment response for individual~     patients varies, where the tumour may not respond to treatment and the quality of patient~     care is compromised if the NACT treatment plan is not optimised. Therefore, the assessment of~     NACT efficacy is beneficial for the early identification of these patients and appropriate~     management of treatment.~      Breast tumours have unique features compared to healthy tissue, including abnormal tissue~     structure and biochemical composition. With NACT there are specific changes to such tumour~     features indicating tumour treatment response.~      The purpose of this study is to establish how the changes to breast tumour features following~     NACT treatment are seen in non-invasive imaging. This study will look at scans of breast~     tumours using magnetic resonance imaging (MRI). Changes to tissue structure will be measured~     by advanced diffusion MRI techniques and changes to tumour related biochemical substances~     will be measured by advanced magnetic resonance spectroscopy techniques. The investigators~     aim to assess if these techniques can provide information on the tumour treatment response~     following subsequent rounds of NACT treatment.~      In this longitudinal study, 25 patients undergoing NACT will be recruited for four repeated~     MRI investigations over the course of NACT treatment. Magnetic resonance (MR) measurements of~     tissue microstructure and biochemical composition will be compared against histological~     measurements and radiological assessments of treatment response.~      The study will recruit patients undergoing treatment at the NHS Grampian. This research is~     funded by Friends of ANCHOR, Tenovus Scotland Grampian and the NHS Grampian Endowment~     Research Fund.~   "
5006|NCT03501381|"~     This is a multicenter, randomized, open label study of high dose interleukin 2 vs high dose~     interleukin 2 plus entinostat in treatment-naïve clear cell RCC patients who are candidate~     for high dose interleukin 2. Patients will be randomized to ARM 1 (high dose interleukin 2~     plus entinostat) or ARM 2 (high dose interleukin 2). Subjects will receive 2 treatments of~     high dose interleukin 600,000 units/kg administered IV every 8 hrs on Days 1-5 and Days 15-19~     (maximum 28 doses) +/- entinostat 5 mg orally given every 2 weeks starting on Day-14,~     continuously. Tumor response assessment will be performed between HD IL 2 treatments.~   "
5009|NCT03501342|"~     Gait disorder, imbalance, and fatigue are the most frequently reported complaints in Multiple~     Sclerosis (MS), a chronic neurodegenerative disease. The first symptoms in patients with MS~     are emerging in the age range 20-50 and these patients need long-term rehabilitation. The~     virtual reality applications developed for these problems which affect the quality of life~     negatively and cause disability in the following periods may be a good alternative for~     conventional rehabilitation applications. In this long-term where motivation is important,~     virtual reality applications in different environments provide patients with the opportunity~     to do many different tasks amused. In recent years, the vividness has been increased by the~     3D virtual reality headsets.~      The aim of this study is to investigate the effects of immersive virtual reality on the~     balance, mobility, and fatigue in patients with MS.~   "
5010|NCT03501329|"~     Patient reported quality of life was measured using the WHO-5 Well-Being Index in a group of~     outpatients in the Community Psychiatry in Holbaek, Denmark.~      Methods~      The first and last answer were compared and significance of change in various subgroups of~     patients was estimated using the PSPP statistical program.~   "
5011|NCT03501316|"~     Primary Objective:~      To identify changes in systemic markers of inflammation following periodontal treatment,~     comparing two standard treatment modalities (hands scaling and ultrasonic scaling)~      Secondary Objectives:~      To investigate bacteraemia, composition and function of oral bacteria, treatment outcomes~     following periodontal treatment, patient and operator preferences, and treatment time~     comparing hand scaling and ultrasonic scaling.~   "
5012|NCT03501303|"~     The primary objective in this study is to investigate if vein grafts harvested and implanted~     with the non-touch technique are superior to conventional vein graft technique with respect~     to mid-term patency, in patients undergoing CABG surgery.~   "
5013|NCT03501290|"~     In this study, patients are supposed to take Fortimel® Protein, an Oral Nutritional~     Supplement (ONS) recommended in case of malnutrition once daily during the study period.~      Three visits will be planned for each patient enrolled in the study (baseline visit, visits~     of follow-up at 4 weeks and 12 weeks). Phone calls will be regularly organized during one~     month or three months according to the duration of supplementation.~      The primary purpose of the OFraDDom study is to assess the compliance with ONS (respect by~     the patient of the physician's prescription) at the end of the first month.~      Data regarding the beneficial effects of ONS, or compliance with ONS in frail elderly~     population, are very limited. The study could complete knowledge about oral nutritional~     supplementation in the undernourished frail elderly people and help to demonstrate that oral~     nutritional supplements have benefits on nutritional status and physical performances in~     frail elderly people.~   "
5014|NCT03501277|"~     The purpose of this study is to assess the relative bioavailability and bioequivalence of 2~     strengths of the FDC tablet product SYR-322-4833 BL compared to the individual alogliptin and~     pioglitazone tablets in healthy Russian participants.~   "
5015|NCT03501264|"~     The purpose of this research study is to conduct a pilot randomized controlled trial of a~     game-based intervention is able to increase help-seeking-related knowledge, attitudes, and~     behaviors, reduce health risk factors/behaviors, and increase resiliencies among sexual and~     gender minority (SGM) youth. The goals of the proposed study are to: (1) Test the feasibility~     and acceptability of a game-based intervention to increase help-seeking-related knowledge,~     attitudes, and behaviors among SGM youth; and (2) Using a randomized controlled trial, test~     the efficacy of a game-based intervention to increase help-seeking-related knowledge,~     attitudes, and behaviors, reduce health risk factors/behaviors, and increase resiliencies~     among SGM youth.~   "
5016|NCT03501251|"~     The study rationale is to provide evidence on effective doses of moxidectin and/or~     moxidectin-albendazole in adolescents (16-18 years old) infected with Trichuris trichiura.~     The study will take place on Pemba Island, Tanzania.~   "
5017|NCT03501238|"~     Participants will be chosen through an initial sensory test to find high and low-perceivers~     of astringency. Selected participants will drink a chocolate milk or milk substitute beverage~     for one week each with washout weeks in between. At the end of each week participants will~     taste and rate multiple beverages for their astringency and other sensory properties.~     Participants will provide saliva samples weekly for proteomic analysis and (potentially)~     analysis of polyphenols. Participants will also be asked to provide a 24 hour dietary recall~     once per week. Data will be analyzed to determine if there is a relationship between~     polyphenol exposure, astringency ratings, and salivary protein composition.~   "
5018|NCT03501225|"~     The aim of this study was to evaluate the effect of ozonated water on pain, edema and trismus~     after third molar removal. Patients were submitted to extraction of lower third molar under~     irrigation with ozonated water or doubly distilled water. Data were collected at baseline, 24~     hours, 48 hours, 72 hours and 7 days after intervention.~   "
5019|NCT03501212|"~     This study evaluate topical anaesthesia application for 30 minutes before tranradial~     catheterization during cardiac catheterization can reduce pain and decrease radial artery~     spasm~   "
5020|NCT03501199|"~     The investigators will use two types of material(PRF-Xenograft) in the buccal gap after~     immediate dental implant placement. The study design has three groups PRF, graft, and control~     group. The patients will randomly be assigned to groups by envelop method. The resonance~     frequency analysis device(Osstell) will be used to measure primary and secondary~     stabilization. Then the investigators will evaluate each materials' contribution to~     stability.~   "
5021|NCT03501186|"~     Gait training in stroke is a complex process of motor learning although restoring patients~     ability to walk would not prepare the individual with the challenges faced in the real~     environment. The aim is not simply walking in controlled environment, but to achieve dynamic~     walking. Dynamic walking is the ability of an individual to adjust to the changing surfaces~     and terrains. thereby returning to achieve active participation in the community. Hence,~     recovery of walking ability is the primary goal when planning treatment for patients with~     stroke.~   "
5022|NCT03501173|"~     The purpose of this study is to document the course of advanced prostate cancer in Canada in~     terms of disease progression, real-world treatment, and patient management.~   "
6077|NCT03487302|"~     The study aims at investigating the role of cyanotic congenital heart disease (cCHD) on brain~     aging. The investigators assume that due to congenital and acquired cardiovascular~     abnormalities, cCHD patients could show radiologic (and clinical) signs of precocious brain~     aging and eventual cognitive decline.~   "
5023|NCT03501160|"~     Social impairment is one of the core symptoms in first episode psychosis and a part of its~     diagnostic criteria. Social impairment not only affects families and working performance but~     also creates distress and disharmony in social interactions and relationships. Despite of~     negative symptoms and social cognitive impairment found in patient suffering from first~     episode psychosis, clinicians occasionally identified socially inappropriate affectionate~     behavior after onset of psychotic disorder. Socially inappropriate affectionate behaviors~     mainly observed in form of childish behavior or regressive behavior. It was found limited~     research focus on schizophrenic regression and social inappropriate behaviors in patient with~     first episode psychosis recently. It was worth to investigate this above observed phenomenon~     and gain more understanding in comorbidity symptoms in first episode psychosis. This study~     was expected to explore the social impairment and socially inappropriate behavior in patients~     with first episode psychosis and provide a descriptive summary and further understanding on~     the above phenomenon. It was expected the sharing from caregivers would offer a good~     opportunity to explore the clinical presentation of socially inappropriate affectionate~     behavior and their perceived burdens and caregiving distress.~   "
5024|NCT03501147|"~     The prevalence and consequences of musculoskeletal pain is considerable among healthcare~     workers, allegedly due to high physical work demands of healthcare work.~      Performing physical exercise at the workplace together with colleagues may be more motivating~     for some employees and thus increase adherence. On the other hand, physical exercise~     performed during working hours at the workplace may be costly for the employers in terms of~     time spend. Thus, it seems relevant to perform a brief intervention. This study is intended~     to investigate the difference between the effect of workplace-based physical exercise (using~     elastic bands and body weight exercises) and a group control on musculoskeletal pain,~     physical exertion during work, physical function, need for recovery, self-rated use of~     analgesics, and work ability among healthcare workers.~   "
5025|NCT03501134|"~     This purpose of this study is to describe the effect of Tumor Treating Fields (NovoTTF) on~     quality of life (QOL), including exercise, sleep quality, and mood, in patients with World~     Health Organization (WHO) Grade IV malignant glioma who have been prescribed and approved to~     receive Optune™. This is an observational, longitudinal study, meaning that information about~     QOL will be collected over time while the patient is using the NovoTTF device (for example,~     Optune™).~   "
5026|NCT03501121|"~     All UK patients who participated in the TARGIT-A Trial were initially treated for early~     breast cancer between 2000-2012. A total of 3451 patients from 33 hospitals in 11 countries~     participated in the trial and a comparison was made between traditional radiotherapy given~     over several weeks (external beam radiotherapy, EBRT) with TARGeted Intraoperative~     radioTherapy (TARGIT-IORT) as a single dose given during the operation to remove the breast~     cancer. The trial was funded by the Health Technology Assessment (HTA) programme of the~     Department of Health, UK and sponsored by University College London. The results from this~     trial have been published in major medical journals and have already started changing the way~     breast cancer in treated around the world; please see www.targit.org.uk for more details. We~     would like to continue to collect data about the health status of all patients to enable us~     to learn about longer term differences in the effects of these treatments on health. An~     analysis of this information could improve treatment for patients with breast cancer. For~     this, HTA have granted us further funding.~   "
5027|NCT03501108|"~     Older people often have several chronic diseases requiring several medications all at once.~     Taking several medications all at once is called polypharmacy. Polypharmacy is common in~     nursing home residents. When people take the same medication long term, the original reason~     for prescribing the medication may no longer be important or a priority. Polypharmacy is~     associated with an increased risk of harmful side effects.~      STOPPfrail is a tool, designed for doctors, that highlights situations where medications may~     be inappropriate or harmful to frail older people. When these situations are identified,~     reducing or stopping the inappropriate medication should be considered. The STOPPfrail tool~     was developed by an expert group specializing in geriatric pharmacotherapy.~      In the present research study, the investigators wish to examine whether medications can be~     safely reduced and stopped using the STOPPfrail tool in hospitalized frail older people who~     are awaiting transfer to a nursing home. The investigators will assess this method by~     comparing its effects with those of the current standard practice of medication management.~      In the trial, participants are allocated to one of two groups. One group will have their~     medications evaluated using the STOPPfrail tool (intervention group). The other group will~     have their medications reviewed in the standard way (control group). The allocation of~     participants into these two groups will be done randomly to avoid any bias in the study. When~     participants are allocated to the intervention group, their physician will receive written~     advice designed to help him/her to adjust medications so as to minimize the risk of~     withdrawal reactions. The advice will be based on the STOPPfrail tool.~      The hospital case notes and discharge summaries of the participants taking part in the trial~     will be reviewed at the time of discharge from hospital. Three months after recruitment, the~     participant's nursing home will be contacted. Information about the number and type of~     medications prescribed will be requested as well as details about hospitalizations, falls and~     the participant's well general well-being.~      The main aim is to examine whether it is possible to significantly reduce the number of~     medications that an older frail person takes using the STOPPfrail tool. The investigators~     will also examine whether reducing the number of medications in this way has an effect on~     quality of life, unscheduled medical care, falls and the cost of medications.~   "
5028|NCT03501095|"~     The delicate structures of the larynx can be compromised by innumerable causes, one of these~     is represented by endotracheal intubation. More frequently, these damages are represented by~     hematomas, edema and granulomas of the vocal cords. The pathophysiology of laryngeal damage~     can be explained by an ischemic attack of the chordal mucosa. Numerous risk factors can cause~     the onset of damage, some depending on the practice itself, such as size and type of~     endotracheal tube, cuff pressure, use of mandrels and / or inserting devices, use of oral or~     nasogastric tubes, use of neuromuscular inhibitors or sleep-inducing drugs and the duration~     of the intervention; others from patient-related factors, such as gender, weight, history of~     exposure of smoking habit, or a history of gastroesophageal reflux (GERD). The incidence of~     such symptoms varies from 0% to 18% among the general population, with an average of 6% with~     resolution of most of the symptoms within 72 hours unless substantial damage has occurred to~     the vocal cords or to the arytenoids. In general, the incidence of such laryngeal~     complications has been described by several studies, but there is no standardized protocol~     for measuring and evaluating their entity. The purpose of this study is to determine how the~     voice and the chordal clinical aspect vary after oro-tracheal intubation, evaluated through~     voice analysis and laryngostroboscopy.~   "
5073|NCT03500497|"~     During a period of a year, reticulocyte hemoglobin content (RetHe) measurements (Sysmex) are~     done out of blood samples taken on several occasions during normal patient care:~        1. preoperatively at the surgical or anesthetic outpatient visit~        2. on admission or pre- induction of anesthesia~        3. postoperatively at the postanesthetic care unit~        4. on day 3 postoperatively~        5. on day 5 postoperatively~      Additionally a Quality of Life (QoL) questionnaire will be taken from the participants before~     surgery and 30 days after surgery to evaluate the course of QoL perioperatively.~   "
5029|NCT03501082|"~     Our guts are home to millions of microbes. These microbes help our bodies do important tasks~     like digesting food, fighting diseases and making vitamins. The type of microbes present in~     our gut depends on factors like diet, the use of medications, and sanitation practices.~     Research shows the diversity of the microbes living in our gut is decreasing, especially as~     countries become more developed. For example, stool samples from rural Papua New Guineans~     contain an additional 50 species not found in people living in the United States.~      What has caused the disappearance of L. retueri is currently unknown. However, it is known~     that in order to help this species to grow specific types of carbohydrates need to be~     consumed. People in North America eat much less of these carbohydrates compared to rural~     Papua New Guineas. Examples of foods containing these carbohydrates include yams, beans, and~     artichokes. It may be possible for L. reuteri to live in the human gut if it is taken as a~     probiotic and a diet containing the types of foods which helps it grow is eaten. Furthermore,~     if L. reuteri can be re-established, it may have beneficial effects on how our immune system~     works.~      The investigators hypothesize that L. Reuteri can be re-established in the gut of Canadians~     when they are fed a diet containing the types of foods known to help it grow. To test this~     hypothesize, the survival of two strains of L. Reuteri in the gut of Canadians will be~     compared when they eat their usual diet, to when they eat a diet containing the types of food~     known to help L. Reuteri survive. We will measure the amount of L. retueri present in stool~     samples of participants, and measure changes in metabolic and immune markers that occur as a~     result of the intervention. This study will help determine if a 'lost' species can be~     reintroduced into the human gut, and if this is associated with immune and metabolic health.~   "
5030|NCT03501069|"~     The purpose of this study is to characterize safety and tolerability of TAK-418 in~     non-Japanese and Japanese healthy female participants when administered at single or multiple~     (once daily [QD]) oral doses.~   "
5031|NCT03501056|"~     This is a phase II Randomized comparison clinical trial of activated CIK armed with~     anti-CD3-MUC1 bispecific antibody for advanced lung cancer. And the aim of this research is~     to study the clinical efficacy and safety of activated CIK armed with anti-CD3-MUC1~     bispecific antibody for lung cancer.~   "
5032|NCT03501043|"~     This pilot study will aim to understand the potential benefit of the assessment of walking~     using video slow motion for muscle selection and the development of an image catalogue guide~     of the potential results of injection of abobotulinumtoxinA by comparing foot postures before~     and after injection. The objective is to evaluate the use of video assessment to improve~     muscle selection for the injection of botulinum toxin A to improve walking outcomes. Primary~     outcomes include: self-selected velocity (SSV), maximal velocity (MV) and symmetry of~     walking. Secondary outcomes include: passive range of motion (PROM), Modified Ashworth Scale~     (MAS) and the Tardieu Scale (TS). Fifteen persons post stroke or TBI over age 18 with~     equinovarus foot deformity who are able to ambulate will be included in the study. Dysport~     1000 to 1500 units will be used to be distributed on the basis of clinical indication to~     ankle plantar flexors (gastrocnemius and soleus), tibialis posterior and long toe flexors.~     The duration of subjects' participation is 4-6 weeks.~   "
5033|NCT03501030|"~     to test the hypothesis that activity restriction in women with singleton gestations and with~     arrested PTL would reduce the rate of PTB.~   "
5034|NCT03501017|"~     Objective: The aim of the first part of this study with two stages is to determine prevalence~     of CVD risk and the associated variables in individuals aged 40-65 years registered in a~     Family Health Center (FHC) in city center of Antalya; the aim of the second one is to~     evaluate the effect of intervention to increase physical activity in individuals with~     moderate risk of CVD on decreasing the risk level.~      Methods: Stage 1 and Stage 2 were conducted as cross-sectional and Randomized Controlled~     Experimental Trial, respectively.~      In the first stage the CVD risk level was calculated using the HeartScore. In the second~     stage, 11 individuals with moderate CVD risk (2-<5%) found in the intervention group~     participated into a 12-week physical activity program (a moderate walk outdoor, with group 5~     days in a week, each lasting for 40 minutes) guided by nurse. CVD brochure and physical~     activity guide was distributed to 11 individuals in control group within the scope of routine~     practice of FHCs.~   "
5035|NCT03501004|"~     The purpose of the study is to compare vascular and functional neurological changes of~     acupuncture in patients with Parkinson's Disease and Sleep Disorders. In the randomized~     controlled clinical trial study, patients meeting the criteria for inclusion will be randomly~     enrolled and divided into two groups in a 1:1 ratio: the acupuncture group and the sham~     acupuncture group. The intervention is going to be executed using the acupoints~     GV14（Dazhui）and GB20 (Fengchi).The acupuncture needles will be inserted to a depth of 0.8 to~     1 cm using GV14（Dazhui）and GB20 (Fengchi) in the acupuncture group. The sham acupuncture~     group's needles will be inserted to a depth of 0.1 to 0.2 cm with nonacupuncture points~     located 0.5 cm in lateral to the real acupoint or to the right for midline points.During the~     study, researchers will observe changes in cerebral blood vessels and neuroimaging before and~     after acupuncture in the two groups. Using multimodal fusion advanced vascular-neuronal~     imaging techniques could evaluate the effect of acupuncture on brain blood vessels and~     function in patients with Parkinson's disease and Sleep Disorders and provide an objective~     neuroimaging basis for assessing the effectiveness of acupuncture.~   "
5036|NCT03500991|"~     This is a Phase 1 study of central nervous system (CNS) locoregional adoptive therapy with~     autologous CD4 and CD8 T cells lentivirally transduced to express a HER2-specific chimeric~     antigen receptor (CAR) and EGFRt, delivered by an indwelling catheter in the tumor resection~     cavity or ventricular system in children and young adults with recurrent or refractory~     HER2-positive CNS tumors. A child or young adult with a refractory or recurrent CNS tumor~     will have their tumor tested for HER2 expression by immunohistochemistry (IHC) at their home~     institution or at Seattle Children's Hospital. If the tumor is HER2 positive and the patient~     meets all other eligibility criteria, including having a CNS catheter placed into the tumor~     resection cavity or into their ventricular system, and meets none of the exclusion criteria,~     then they can be apheresed, meaning T cells will be collected. The T cells will then be~     bioengineered into a third-generation CAR T cell that targets HER2-expressing tumor cells.~     The patient's newly engineered T cells will then be administered via the indwelling CNS~     catheter for two courses. In the first course they will receive a weekly dose of CAR T cells~     for three weeks, followed by a week off, an examination period, and then another course of~     weekly doses for three weeks. Following the two courses, patient's will undergo a series of~     studies including MRI to evaluate the effect of the CAR T cells and may have the opportunity~     to continue receiving up to a total of six courses of CAR T cells if the patient has not had~     adverse effects and if more of their T cells are available.~      The hypothesis is that an adequate amount of HER2-specific CAR T cells can be manufactured to~     complete two courses of treatment with three doses given on a weekly schedule followed by one~     week off in each course. The other hypothesis is that HER-specific CAR T cells safely can be~     administered through an indwelling CNS catheter to allow the T cells to directly interact~     with the tumor cells for each patient enrolled on the study safely can be delivered directly~     into the brain via indwelling catheter. Secondary aims of the study will include to evaluate~     CAR T cell distribution with the cerebrospinal fluid (CSF), the extent to which CAR T cells~     egress or traffic into the peripheral circulation or blood stream, and, if tissues samples~     from multiple time points are available, also evaluate the degree of HER2 expression at~     diagnosis versus at recurrence.~   "
5074|NCT03500484|"~     To study the effects of liraglutide on neural responses to high fructose corn syrup (HFCS) in~     individuals with obesity.~   "
5075|NCT03500471|"~     This study is a prospective, single-center, non-randomized, controlled, non-blind, and~     non-inferiority observation trial comparing robotic-assisted total gastrectomy with D2 lymph~     nodal dissection for locally advanced gastric cancer patients with laparoscopic procedure.~   "
5037|NCT03500978|"~     Unintended pregnancy (UP), defined as a mistimed or unwanted pregnancy, is a significant and~     prevalent public health problem, particularly among low-income women. Over half of all~     pregnancies are reportedly unintended and UP has been linked to adverse health outcomes in~     mothers and their children. Correct and consistent use of effective contraception is the~     primary method to prevent UP. Research has shown that low self-esteem and elevated depressive~     symptoms increase women's risk for ineffective contraception use and, by extension, for UP.~     This project examines the feasibility and possible efficacy of reducing ineffective~     contraception using an intervention that addresses depressive symptoms and self concept among~     young, low-income, predominantly minority women at risk for UP. Traditional cognitive~     behavioral therapy (CBT) is effective in reducing depressive symptoms and improving self~     concept; but limited utilization, poor response, and low adherence to CBT is common among~     low-income and minority women. A more acceptable method for delivering CBT is needed for the~     target population. This project will use peer-specialists to deliver a CBT-based intervention~     to women at risk for UP. Because peer specialists are drawn from the same community as the~     target population and share some similar life experiences, the intervention may be more~     acceptable and effective than one offered by trained professionals.~      This project will examine the effectiveness of a 9 week (8-session) peer-specialist led~     CBT-based intervention compared to an observational control condition to reduce depressive~     symptoms, improve self-esteem, and improve consistent contraceptive use to prevent UP. The~     weekly intervention sessions are delivered by telephone by a trained peer specialist. The~     study will evaluate the effectiveness of the intervention to improve consistent contraceptive~     use (primary outcome) and decrease depressive symptoms and increase self-esteem (secondary~     outcomes).~   "
5038|NCT03500965|"~     Pictorial cigarette warning labels (PWLs) are thought to increase risk knowledge, but~     experimental research has not examined PWLs' longer term effects on memory for health risks.~     In this study, teens who have experimented with smoking or are considered vulnerable to~     smoking are repeatedly exposed to text-only vs. graphic warning labels paired with numeric~     risk information. This study will allow us to assess the extent to which reactions to~     warnings remain consistent over time and influence future smoking intentions. We will also~     assess the impact of graphic images on memory for smoking risk information presented in~     absolute and (a smokers lifetime risk of getting a smoking related disease), or relative (a~     smokers risk of getting a smoking related disease, compared to the risk of non-smokers)~     formats.~   "
5039|NCT03500952|"~     Family Planning Ahead is a study that aims to improve decision-making about postpartum~     contraception. Family Planning Ahead will test two different strategies: a patient decision~     aid and a patient information leaflet.~   "
5040|NCT03500939|"~     The main objective of the PROOF trial is to investigate efficacy and safety of normobaric~     hyperoxygenation (NBHO) as a neuroprotective treatment in patients with acute ischemic stroke~     due to large vessel occlusion likely to receive endovascular mechanical thrombectomy (TBY) in~     a randomized controlled clinical phase IIb trial.~   "
5041|NCT03500926|"~     This randomized controlled trial will compare patients receiving a standard uncemented~     femoral stem with patients receiving an identically designed short uncemented femoral stem.~   "
5042|NCT03500913|"~     This study will examine adipose tissue inflammation and adipokine expression and serum~     markers of inflammation and adipokine levels in patients with growth hormone (GH) deficiency~     before and after treatment.~   "
5043|NCT03500900|"~     Dipeptidyl peptidase-4 (DPP-4) inactivates glucagon-like peptide-1 (GLP-1). Whether DPP-4~     inhibition affects GLP-1 metabolism in vivo and/or food intake remains unknown.~      The aim of this study is to evaluate the effect of vildagliptin (DPP-4 inhibitor) on gastric~     accommodation and ad libitum food intake in healthy volunteers (HVs).These effects will be~     evaluated in two randomized, placebo-controlled, single-blinded trials. Each protocol will~     include ten volunteers.~      Protocol 1: Sixty minutes after treatment a nutrient drink (270 kcal) will be~     intragastrically infused and intragastric pressure (IGP) will be measured for one hour.~      Protocol 2: 60 min after treatment the participants consume one nutrient drink (300 kcal).~     Thirty minutes hereafter, the participant will eat ad libitum from a free-choice buffet for~     30 minutes. Blood will be collected at several time points to measure active GLP-1 plasma~     levels.~   "
5044|NCT03500887|"~     In this pilot study the investigators test the hypothesis that gastric motility can be~     measured with an intragastric balloon.~   "
5045|NCT03500874|"~     The aim of the trial is to optimize the overall survival of patients with resectable~     colorectal liver metastasis who have undergone liver metastasis resection. The patients will~     be treated with systemic chemotherapy plus hepatic arterial infusion With floxuridine, or~     with systemic chemotherapy only~   "
5046|NCT03500861|"~     In this double-blind randomized trial, we aimed to explore the effectiveness of trigger point~     dry needling in patients with chronic tension type headache (CTTH) in reduction of headache~     frequency, intensity, duration, and improvement of health-related quality of life (HRQoL).A~     total of 160 CTTH patients participated in this double-blind, sham-controlled randomized~     trial. The patients received dry needling using sterile stainless-steel acupuncture needles~     of 0.25x40 mm and 0.25x 25 mm dimensions three times a week for 2 weeks. The primary outcome~     measurement which was the headache intensity and, the secondary outcome measurements which~     were the headache frequency and duration were collected using a headache diary before and~     after treatment. Another secondary outcome measurement which was the health related quality~     of life was measured before treatment and at the end of the 1-month follow-up period. HRQoL~     assessments of patients were performed using Short Form-36 (SF-36). In the dry needling (DN)~     group, both the primary outcome measurements and the scores of SF-36 subscales were~     significantly improved after treatment. In the DN group, all effect sizes for headache~     variables were large. The results of this clinical trial suggest that trigger point dry~     needling in patients with CTTH is effective and safe in reduction of headache frequency,~     intensity, duration, and increasing health-related quality of life.~   "
5047|NCT03500848|"~     This is a multicenter, open-label, randomized, controlled clinical trial, in order to compare~     sirolimus-based (tacrolimus-free) versus tacrolimus-based (sirolimus-free) immunosuppression~     regimen for Hepatocellular Carcinoma (HCC) patients after liver transplantation.~   "
5076|NCT03500458|"~     Many teenagers do not get enough sleep. Obesity and diabetes are increasing in teenagers as~     well. This study plans to learn more about sleep and insulin resistance (insulin not working)~     in teenagers, and how these things may be related depending on sleep. This is important to~     know so that the investigators understand how sleep may play a role in health conditions like~     extra weight gain (increased food intake and less physical activity) and diabetes. To answer~     this question, the investigators plan to enroll teenagers who get <7 hours of sleep on school~     nights and measure changes in insulin sensitivity and dietary intake after a week of typical~     sleep (sleeping on their normal school schedule) and a week of longer sleep (spending 1+ hour~     longer in bed each night).~   "
5077|NCT03500445|"~     The purpose of this study is to determine response rate after 8 cycles of D-KRd (daratumumab,~     carfilzomib, lenalidomide (Revlimid) and dexamethasone in patients with multiple myeloma.~   "
5048|NCT03500835|"~     New and creative approaches are needed to address childhood obesity. Current strategies~     result in suboptimal outcomes and are intensive and costly. It has been theorized that~     overeating, may have addictive qualities, although few weight management interventions have~     tested therapeutic techniques founded on addiction medicine principles, such as, withdrawal,~     tolerance and craving control1, 2. A pilot study utilizing an addiction model based mobile~     health (mHealth) weight-loss intervention in adolescents showed that the app intervention~     reduced BMI Z-score (zBMI) to a greater extent than youth participating in an in-clinic~     multidisciplinary weight management intervention, and appeared to be a cost-effective, labor~     efficient method for adolescent weight management.~      The proposed multi-site randomized control trial (RCT) will test the effectiveness of an~     addiction-based weight loss intervention, embodied first as a smartphone app with telephone~     coaching and second as an identical approach phone-coaching alone intervention compared to~     age matched controls participating in an in-clinic weight management interventions in a~     larger sample of economically, racially and ethnically diverse adolescents (ages 14-18).~      One hundred and fifty adolescents will be recruited from pediatric interdisciplinary weight~     management clinics operating out of five different hospital systems in Southern California.~     The adolescents will be randomized 1:1 via stratified block randomization to either receive~     1) six-month interactive addiction model based mobile health (mHealth) weight-loss~     intervention with personalized phone-coaching, 2) six-month addiction-based phone coaching~     weight loss intervention alone or 3) six-month addiction model based mHealth weight loss~     intervention alone. Assessment of the intervention's effect on zBMI and percent over the 95th~     percentile (%BMIp95), fasting metabolic parameters, addictive eating habits, executive~     function, and motivation for change will be obtained at enrollment, 3, 6, 12 and 18 months (1~     year post intervention follow up). In addition, a real-life economic analysis (cost,~     cost-saving and non-monetary benefits) analysis will be completed. We will further explore~     whether primary and secondary outcomes differ by race and whether race moderates the~     relationship between initial intervention efficacy and prolonged weight maintenance.~   "
5049|NCT03500822|"~     The aim of this study is to identify whether actively induced dynamic hyperinflation can~     cause left-ventricular diastolic dysfunction in healthy male subjects in order to explore the~     mechanisms of developing cardiac dysfunctions in patients with COPD.~   "
5050|NCT03500809|"~     Intraocular pressure (IOP) rise after cataract surgery is an important and common problem.~     Over 300,000 cataract operations are done per year in the United Kingdom alone. IOP rise can~     adversely affect vision and can be particularly detrimental in glaucoma patients with~     pre-existing visual field defects. The aim of this study is to evaluate the efficacy and~     safety of aqueous humor release (also known as burping of the wound), a procedure that has~     been used for decades to quickly reduce acute IOP spikes following cataract surgery.~      Currently there is no published evidence on a standard technique to perform wound burping.~     Similarly there is uncertainty around the amount and duration of the IOP decrease, and the~     type and frequency of complications eventually associated. This will be the first research~     project formally evaluating this procedure. This study will also help allay issues over fluid~     release in high IOPs and consequences of such dramatic IOP drop which concerns~     ophthalmologists who do not routinely use this technique.~   "
5051|NCT03500796|"~     Use of amniotic membrane(AMT) and platelet rich plasma (PRP) clot for closure of central~     corneal perforation~   "
5052|NCT03500783|"~     This prospective randomized study elucidates the effects of exogenous nitric oxide delivered~     to the extracorporeal circulation circuit for cardioprotection against ischemia-reperfusion~     injury during coronary artery bypass graft surgery with cardiopulmonary bypass.~   "
5053|NCT03500770|"~     The main purpose of this study is to see if a device known as Transcranial Direct Current~     Stimulator (tDCS) is helpful in reducing persistent symptoms after Lyme disease treatment.~     Some of these symptoms include problems with memory, fatigue or pain.~   "
5054|NCT03500757|"~     Medical images used to guide treatment of tumor(s) are presently displayed on flat-panel~     monitors (like screens used with computers). This protocol will evaluate, using a new headset~     to view the images in true 3D (360 degrees), while using standard flat panel monitors as~     usual (in accordance with standard of care). The headset is combined with a mini-global~     positioning system (GPS)-like system to help navigate to treat tumor(s). This evaluation is~     to show that the headset has potential to provide guidance and navigation information that~     can improve the treatment of tumor(s) with heat.~   "
5055|NCT03500744|"~     Regional anesthesia, also know as a nerve block, is a key component of pain control after~     major abdominal surgery. Bilateral erector spinae plane block (ESPB) performed at low~     thoracic level has been shown to be an effective pain control method in case reports. This~     pilot study aims to further characterize the pain-control characteristics and to provide~     baseline data for future trials.~   "
5056|NCT03500731|"~     The purpose of this study is to determine whether a lung transplantation prior to bone marrow~     transplantation (BMT) would allow for restoration of pulmonary function prior to BMT,~     allowing to proceed to BMT, to restore hematologic function.~   "
5057|NCT03500718|"~     After cochlear implantation, cochlear nerve is stimulated by giving a current over the~     electrodes placed in the cochlea and the current is measured by electrically evoked Compound~     Action Potential (ECAP).This ECAP is measured intra operatively, after 4 weeks( at switch~     on), after 3months and 6 months following cochlear implantation.~   "
5058|NCT03500705|"~     This is a pilot randomised controlled trial investigating a combination of unilateral~     strength training (cross-education) and mirror therapy for the rehabilitation of upper limb~     impairment following a stroke. This study has been conducted as part of a PhD qualification~     at the Institute of Technology Sligo in Ireland with all assessments being conducted at the~     institute and all therapy sessions taking place at the participant's home. The study was~     conducted in conjunction with Sligo University Hospital and it attained ethical approval~     through the relevant University Hospital Ethics Committee.~   "
5059|NCT03500692|"~     The purpose of the MitraClip post-marketing clinical use surveillance study is to observe the~     frequency, type and degree of adverse device effects and adverse events in order to assure~     the safety of the new medical device, and to collect safety and efficacy information for~     evaluating the results of the clinical use.~   "
5060|NCT03500679|"~     The purpose of this study is to evaluate the safety/reactogenicity of the ExPEC4V clinical~     trial material (CTM) after the first vaccination and to evaluate the immunogenicity of the~     ExPEC4V CTM, as measured by the enzyme-linked immunosorbent assay (ELISA), 14 days after the~     first vaccination (on Day 15).~   "
5061|NCT03500666|"~     Objective to compare the advantages and disadvantages of robotic and conventional endoscopic~     thyroidectomy for thyroid cancer.~   "
5100|NCT03500120|"~     The present study was undertaken prospectively to compare the diagnostic significance of the~     SSST with the CCT in hypertensive patients with suspected PA using the FST as the reference~     standard, and to investigate the optimal cutoff of SSST for differentiating PA from other~     forms of hypertension.~   "
25367|NCT03234933|"~     This research study is evaluating the postoperative results in terms of quality of life and~     functional recovery of elderly patients after cancer surgery.~   "
5062|NCT03500653|"~     Introduction: The pathogenesis of inflammatory bowel diseases (IBD) is characterized by~     dysregulation of the innate immune response it's associated with Th1, Th17 up-regulation,~     reflected by increased cytokine secretion including TNF-α. A main effective therapeutic~     interventions is blocking TNFα. Vedolizumab, an anti integrin, is a new class of treatment~     designed to block trafficking of lymphocytes in the gut. Clinical trials and real life~     experience response rates at week 6 range between 30-45%. Curcumin suppresses NFκβ levels via~     alteration of TLR2/4 pathways lowering TNF-α upstream. Curcumin is safe and efficacious in~     inducing response and remission in mild-moderate Ulcerative colitis (UC) and maintaining~     remission when used as an add-on to 5ASA derivatives, only with strict adherence to treatment~     overtime.~      Objectives: Facing the low rate of response to therapies in IBD, the need for new treatments~     and the use of combination strategies lead us to believe that combining vedolizumab and~     curcumin may have a synergistic effect and will enable optimal immunomodulation.~      Hypothesis: Concomitant oral curcumin in IBD patients with colonic involvement will augment~     remission rates as well as clinical and biochemical response.~      Type of research and methods of data collection: A randomized controlled trial in 84 adults~     with colonic IBD (UC and CD). Eligible patients are during vedolizumab induction, patients~     will randomized will be into curcumin or placebo. Data will managed by investigators.~   "
5063|NCT03500640|"~     Obesity and pre-diabetes threatens the overall health and functional independence of elders~     but lifestyle weight management for diabetes prevention, soon to be reimbursed by Medicare,~     can reduce this burden. The current 24-month study will enroll adults, ages 60 and older,~     through senior community centers. The investigators will study how two long term weight loss~     maintenance programs, using group telephone sessions to support health behavior change,~     impact meaningful health outcomes. If successful, this project will provide a sustainable~     intervention model for healthy aging services that can benefit older adults and society.~   "
5064|NCT03500627|"~     A clinical study to measure the effect of OP-101 after being administered intravenously in~     healthy volunteers.~   "
5065|NCT03500614|"~     This study aims to evaluate whether a short-term intervention strategy using air cleaner~     reduces indoor exposure to airborne particles (particulate matter with an aerodynamic~     diameter ≤2.5μm, PM2.5) and phthalates and improves cardiopulmonary health among Chinese~     healthy adults based on a randomized double-blinded crossover trial.~   "
5066|NCT03500601|"~     Tree nuts (for example brazil nuts, almonds, hazelnuts, walnuts, cashew nuts etc) contain a~     wide variety of nutrients including fatty acids, polyphenols and micronutrients. The~     beneficial health effects ascribed to the consumption of tree nuts include improvements to~     cardiovascular outcomes and regulation of glucose levels and inflammation. Emerging evidence~     suggests that specific components of nuts may also contribute to brain health and function.~      The aim of the present study is to assess the effects of four weeks' supplementation of nut~     components on cognition and subjective measures. Urinary metabolites and intestinal microbial~     communities will also be assessed allowing biomarkers of nut exposure to be highlighted.~   "
5067|NCT03500588|"~     In this study the investigators assessed one of the released protein factors during~     pathophysiology of preeclampsia. They evaluated vascular endothelial growth factor gene~     mutation which affects the angiogenesis in case of inadequate placentation.~   "
5068|NCT03500575|"~     Background/Rationale Acute rejection (AR) is common in the first year after lung~     transplantation. AR has usually been reversible with treatment, but it can trigger chronic~     rejection that is the leading causes of late morbidity and mortality. Extracorporeal~     photopheresis (ECP) has emerged as a promising treatment for chronic rejection. The~     investigators postulate that the immunoregulatory property of ECP could promote graft~     tolerance immediately after lung transplantation.~      Objectives The aim of this trial is to evaluate the safety and efficacy of ECP as induction~     therapy for prevention of AR in recipients affected with cystic fibrosis in the first year~     after lung transplantation. The extracellular vesicles in the cell-to-cell communication and~     immunomodulation will be also investigated.~      Preliminary results (personal) A preliminary study, conducted in Vienna, demonstrated that 9~     patients treated with ECP as induction therapy had 0% of chronic rejection versus 50% in the~     control group. The Institution hosting the current project is among largest lung~     transplantation centers in Italy with high rate of cystic fibrosis recipients. The~     Institution has experience in ECP and a dedicated instrument was specifically bought for the~     project. Internal collaborators have strong expertise in biological aspects including the~     extracellular vesicle compartment.~   "
5069|NCT03500562|"~     Study is a non-interventional, prospective, multicenter post marketing surveillance study to~     determine the safety of daclatasvir based therapy~   "
5070|NCT03500549|"~     Evaluation of the Efficacy and Safety of APL-2 in Patients with Paroxysmal Nocturnal~     Hemoglobinuria~   "
5071|NCT03500536|"~     The clinical study is meant to optimize the mobile intervention, to develop a robust~     implementation plan within primary care, and to conduct an effectiveness trial, randomizing~     128 participants in order to understand effect on severity of depression and anxiety~     symptoms, cost-effectiveness, and usability of mobile apps.~   "
5072|NCT03500523|"~     57 eyes of 57 healthy pregnant women who were visiting Obstetrics and Gynecology department~     for routine examination and 26 eyes of 26 non pregnant control subjects who were at the first~     week of the menstrual cycle were enrolled in the study. All subjects had a detailed~     ophthalmologic examination including the best corrected visual acuity with a Snellen chart,~     slit- lamp biomicroscopic evaluation, and indirect fundoscopy. The biomechanical properties~     Corneal Hysteresis, Corneal resistance factor, corneal compensated intraocular pressure and~     Goldmann-correlated intraocular pressure values were measured with ORA (Ocular Response~     Analyzer, software version 1.02, Reichert, Inc.) Central corneal thickness was measured with~     a built-in ultrasonic pachymeter attached to the ORA device.Axial length , Anterior chamber~     depth , and keratometry readings were acquired with an ocular biometer (IOLMaster; Carl-Zeiss~     Meditec, Inc.) before CCT determinations had been taken. Results of these parameters were~     compared between pregnant group and healthy control group.~   "
5525|NCT03494543|"~     In this single-center experience we retrospectively evaluated principal clinical outcomes of~     endoscopic papillectomy in all patients referred to our unit. The same evaluation was then~     performed dividing sproradic ampullary adenoma from familial adenomatous polyposis associated~     adenomas, and resulting outcomes were compared.~   "
5078|NCT03500432|"~     In comparison with transrectal prostate biopsy, transperineal prostate biopsy has the~     advantage of better sampling from the anterior area, low risk of infection, and no rectal~     bleeding. The main problems associated with the transperineal method are pain control and~     additional general or spinal anesthesia. Three types of anesthesia have been reported for~     transperineal prostate biopsy: (1) spinal anesthesia; (2) general anesthesia; and (3) local~     anesthesia. From the viewpoint of patient selection (general anesthesia is contraindicated in~     some patients) and medical cost, local anesthesia is the most suitable choice for prostate~     biopsy. Periprostatic block is the standard method of local anesthesia for this procedure.~     However, periprostatic block is insufficient for transperineal prostate biopsy due to high~     pain sensitivity in this region. A number of new methods to eliminate pain have been~     reported, including (1) periapical triangle (PAT) block, (2) paraprostatic plus sexual nerve~     block, and (3) periprostatic block plus pudendal block.However, there is no anatomical basis~     for some of these methods, and there have been no randomized controlled trials to evaluate~     their effectiveness, and some methods are technically difficult to learn. In the previous~     perineal nerve autopsy, we found that there are two branches leading into the prostate and~     anterior lateral prostatic tissue, which is the main site of puncture pain. There is a fixed~     position where the two branches appear. Therefore, this anatomical position block may be a~     useful site for local anesthesia. We named this location the 'transperineal prostate biopsy~     local anesthesia switch' (abbreviated as TPA switch). In order to validate its effect, we~     organized this clinical trail.~   "
5079|NCT03500419|"~     The objective of the current study is to evaluate the efficacy of a novel, class I (ie.~     lowest risk, clinical studies not required) medical penile traction device in preventing loss~     of penile length in men undergoing robotic-assisted prostatectomy.~   "
5080|NCT03500406|"~     This study is intended to utilize a novel, class I (ie. lowest risk, clinical studies not~     required) medical device to determine whether penile length can be increased in men prior to~     undergoing a penile prosthesis implantation procedure.~   "
5081|NCT03500393|"~     The purpose of this study is to conduct a pilot randomized controlled trial (RCT) evaluating~     the feasibility and potential effectiveness of a remotely supervised exercise program (REM)~     in promoting adherence to an exercise prescription before and during chemoradiation.~   "
5082|NCT03500380|"~     This is a Phase II, randomized, multicenter, 2-arm, open-label clinical trial designed to~     compare the safety and efficacy of RC48-ADC with that of capecitabine + lapatinib in~     participants with human epidermal growth factor receptor 2 (HER2)-positive locally advanced~     or metastatic breast cancer. Participants will be treated until disease progression (PD),~     unmanageable toxicity, or study termination. Once disease progression is reported, all~     participants will be followed for survival every 3 months until death, loss to follow-up,~     withdrawal of consent, or study termination.~   "
5083|NCT03500367|"~     A prospective non-randomized open label clinical trial to research the efficacy and safety of~     sirolimus in patients with symptomatic, recurrent uterine fibroids or/and various rare~     leiomyoma.~   "
5084|NCT03500354|"~     Gastroparesis is a chronic, morbid and costly neuromuscular disorder of the stomach~     characterized by delayed gastric emptying in the absence of gross structural abnormalities.~     The periprandial symptoms associated with this disease can preclude adequate oral intake and~     often lead to weight loss and nutritional deficiencies 1. These manifestations are largely~     due to impaired gastric accommodation of meals and delayed transfer of food boluses from the~     stomach into the duodenum2. Consequently, the investigators hypothesize that dietary~     supplementation with a low volume, hypercaloric nutritional drink can help prevent~     malnutrition, decrease symptom burden and improve health-related quality of life in this~     population. Due to the paucity of such a supplement, the investigators developed a novel~     nutritional drink designed to maximize tolerability in patients with gastroparesis . This~     nutritional drink was tested on healthy volunteers (phase I) and passed the palatability~     test. The investigators now aim to test the tolerability of this drink on gastroparesis~     patients.~   "
5085|NCT03500328|"~     FDA-approved multiple sclerosis (MS) disease-modifying therapies (DMTs) target the relapsing~     phase of MS but have minimal impact once the progressive phase has begun. It is unclear if,~     in the relapsing phase, there is an advantage of early aggressive therapy with respect to~     preventing long-term disability. The infectious risks and other complications associated with~     higher-efficacy treatments highlight the need to quantify their effectiveness in preventing~     disability.~      The TRaditional versus Early Aggressive Therapy for MS (TREAT-MS) trial is a pragmatic,~     randomized controlled trial that has two primary aims: 1) to evaluate, jointly and~     independently among patients deemed at higher risk vs. lower risk for disability~     accumulation, whether an early aggressive therapy approach, versus starting with a~     traditional, first-line therapy, influences the intermediate-term risk of disability, and 2)~     to evaluate if, among patients deemed at lower risk for disability who start on first-line MS~     therapies but experience breakthrough disease, those who switch to a higher-efficacy versus a~     new first-line therapy have different intermediate-term risk of disability.~   "
5086|NCT03500315|"~     The primary objective of this study is to determine if an HIV-infected deceased kidney donor~     (HIVD+) transplant is safe with regards to major transplant-related and HIV-related~     complications.~   "
5087|NCT03500302|"~     The investigators propose a pilot study using (1) MRI to assess coronary artery endothelial~     function, (2) brachial ultrasound to assess systemic endothelial function, (3) serum markers~     of inflammation and of endothelial cell function and (4) echocardiographic measures of left~     ventricular diastolic and systolic properties, before and following initiation of PCSK9~     antibody in HIV positive subjects.~   "
5088|NCT03500289|"~     Multiple sclerosis (MS) is an inflammatory, demyelinating and degenerative disease of the~     central nervous system and, after trauma, is the most common cause of disability in young~     adults, affecting more than 400,000 individuals in the US. Of all the symptoms that can occur~     with MS, chronic fatigue is the most common and disabling, reported by at least 75% of~     patients at some point. Fatigue limits patients' daily activities, and challenges employment,~     resulting in substantial socioeconomic consequences. Despite this negative impact, fatigue~     treatments have been inconsistently studied, in part due to poorly understood underlying~     pathophysiological mechanisms. Yet to be defined biological processes and lack of clear~     treatment targets have also hampered the development of drugs for fatigue. As a result, there~     are no medications approved by the Food and Drug Administration (FDA) for the treatment of MS~     fatigue.~      The investigators recently reported that riluzole, a medication with anti-glutamatergic~     effects, increased the fatigue severity in patients with relapsing MS who had participated in~     a clinical trial evaluating potential neuroprotective effects of riluzole versus placebo.~     Three other clinic trials which examined memantine effects on cognition in patient with MS~     also reported worsening fatigue as a major side effect. Memantine main mechanism of action is~     blocking the N-methyl D-aspartate (NMDA) glutamate receptor. These observations prompted us~     that glutamatergic transmission probably plays an important role in fatigue pathogenesis and~     modulating these pathways could have potential therapeutic effect on MS-related fatigue. A~     recent paper reported that ketamine, an NMDA receptor blocker with different kinetics~     compared to memantine, had a strong and prolonged effect in reducing fatigue in bipolar~     patients who participated in a clinical trial, evaluating anti-depressive effects of ketamine~     versus placebo. Interestingly, the effect of ketamine on fatigue was independent of its~     antidepressant effects.~      The primary objective of this study is to determine if modulating glutamatergic transmission~     with ketamine is safe and efficacious in improving MS-related fatigue. These objectives will~     be answered in a proof of concept, randomized controlled trial of ketamine versus an active~     placebo (midazolam) in patients with relapsing or progressive MS who have clinically~     significant fatigue.~      18 patients with MS and reported fatigue, will be randomized 2:1 to one infusion of ketamine~     0.5 mg/kg over 40 minutes versus one infusion of midazolam 0.05 mg/kg over 40 minutes.~     Midazolam is chosen as an active placebo to keep the participants blinded to their medication~     assignment. Primary outcome of the study will be Daily Fatigue Severity measured daily from~     day one through day seven post-infusion.~      Secondary outcomes of the study include other fatigue questionnaires, depression and~     sleepiness. The length of study will be around 28 days.~   "
5089|NCT03500276|"~     The purpose of this study is to investigate the effects of a yoga program based on Yoga in~     daily life system in patients with rheumatoid arthritis.~      The investigators want to explore whether this program will improve health-related quality of~     life and psychological well-being in patients. In addition they want to explore its potential~     positive modulation of the immune system.~   "
5090|NCT03500263|"~     The study is a randomized, double-blind, placebo-controlled, study that will be conducted at~     multiple centers in subjects with Cystic Fibrosis (CF) who are homozygous for the F508del~     mutation.~   "
26486|NCT03220295|"~     This is a safety study of the molecule VU319 to ascertain pharmacokinetic and pharmacodynamic~     data and test cognitive enhancement in healthy volunteers.~   "
5091|NCT03500250|"~     Rationale: Depression is a frequent complication after a stroke. In stroke guidelines several~     recommendations focus on early screening, and treatment off depression after stroke.~     Introducing clinical practice guidelines into routine daily practice however, is a difficult~     process. In order to make the recommendations applicable to clinical practice a toolkit was~     developed (the Post Stroke Depression-toolkit), which provides assessment tools for the early~     detection of depression after stroke, and a set of interventions in case of a positive~     screening for (risk on) depressive symptoms.~      Objective: to investigate the feasibility of the Post Stroke Depression-toolkit in daily~     practice.~      Study design: An explanatory mixed-methods, before-and-after study design. Study population:~     Nurses working on the neurological wards of one university hospital and two general hospitals~     in the Netherlands were included in the study. Additionally, data were obtained from patient~     charts.~   "
5092|NCT03500237|"~     Chronic health conditions (e.g., heart disease, cancer, diabetes) represent any physical~     condition that persist for 3 months or more that requires ongoing management. Chronic health~     conditions are very common, and increase in prevalence with age. Internet-delivered Cognitive~     Behaviour Therapy (ICBT) is a promising approach for overcoming these barriers, and improving~     access to mental health care. In ICBT, clients receive content from traditional face-to-face~     CBT over the Internet, while receiving support and assistance from a guide through secure~     e-mail. The Chronic Conditions Course is an 8-week, 5 lesson ICBT program that consists of~     education and relapse prevention as well as cognitive, behavioural, and physical strategies~     for managing chronic conditions. This intervention has traditionally been delivered either~     with no support or with weekly brief (15 minute) individual therapist guidance via email and~     phone. However, in order to provide a faster response to clients using an on the demand~     (responding as quickly as possible and for sure within one business day team based approach~     (e.g., first available therapist responds) may be beneficial.~      The proposed trial will examine the Chronic Conditions Course delivered by a team at the~     Online Therapy Unit based at the University of Regina versus a self-directed program. In the~     team based approach, participants will be able to contact the Online Therapy Unit if they~     have any questions regarding the content of the Chronic Conditions Course during the 8 week~     program. Participants in this group will receive a response from one of the members of the~     team within one business day. In the self-directed group, clients will receive automatic~     messages from the Online Therapy Unit that encourage participation during the 8 week program~     but otherwise will work on the course on their own. All participants will complete~     questionnaires prior to the start of the program, before each lesson of the program, once~     they have completed the program, and 3 months after completing the program. The primary~     outcome measures include anxiety and depression. Secondary outcomes include fatigue, pain,~     self-efficacy, disability, overall quality of life, and life satisfaction.~   "
5093|NCT03500224|"~     The purpose of this study is to determine the mass balance, routes of elimination and~     characterize the metabolic profiles of a single intravenous dose of [14C]-TAK-954, identify~     major circulating and excreted metabolites. This study will also determine the single-dose PK~     of total radioactivity, TAK-954 and its metabolites where possible.~   "
5094|NCT03500211|"~     Randomized control trial evaluating use of lidocaine vs placebo patch for post-operative~     cesarean incision pain.~   "
5095|NCT03500185|"~     The aim of the study is to compare the efficacy of a protocol, pelvic floor muscle training~     (PFMT), applied in a group and at home for urinary incontinence (UI) in women. Probably, the~     group-applied PFMT protocol is more effective in women with UI than the home protocol.~   "
5096|NCT03500172|"~     The Siyaphambili Study is a sequential multistage adaptive randomized trial (SMART) to~     compare the effectiveness and durability of two behavioral interventions on the HIV-1~     virologic response among female sex workers (FSW) living with HIV in Durban, South Africa.~     The interventions are: 1) nurse-led decentralized treatment program (DTP) and 2)~     individualized case management (ICM). Viral suppression is defined as a viral load assessment~     <50 RNA copies/mL. The design will also estimate the incremental cost-effectiveness of study~     interventions and combinations of interventions compared with maintaining the South African~     standard of HIV care and treatment.~   "
5097|NCT03500159|"~     This is a randomized, multi-center, double-blind, parallel-group study, enrolling~     approximately 100 male subjects diagnosed with CP/CPPS to evaluate the effect of 12-week~     treatment with AQX-1125 (active drug) compared to placebo.~      The subjects will be randomized to receive orally once-daily either AQX-1125 (200 mg) or~     placebo in a 1:1 ratio across approximately 30 centers in North America (United States and~     Canada). The study will consist of a screening period of up to 3 weeks, a 12-week treatment~     period followed by a 4-week off drug safety follow-up period, and an ophthalmic safety~     follow-up call at 3 months and visit at 6 months post last dose, for a total study duration~     of about 41 weeks.~   "
5098|NCT03500146|"~     Sexual dysfunction affects approximately 45% of women with an even greater incidence reported~     in women with overactive bladder symptoms, despite this there is a lack of FDA approved~     treatments for sexual dysfunction in this population. While both medical therapy and~     electrical neuromodulation have been shown to improve urinary function as well as sexual~     function, there is a dearth of literature about their comparative effectiveness in the~     latter. The purpose of this study is to examine the comparative effectiveness of~     neuromodulation via percutaneous tibial nerve stimulation (PTNS) and medical therapy with~     anticholinergics or beta-agonists in improving female sexual function. This will be a~     prospective multi-center cohort study comparing improvement in sexual function as measured by~     the female sexual function index (FSFI). It is hypothesized that PTNS will improve sexual~     function to a greater degree than medical therapy as there may be mechanisms by which PTNS~     directly affects sexual function. Enhanced understanding of the effects of neuromodulation~     and medical therapy on sexual function may allow for improved patient selection and better~     outcomes which may lead to widespread use of neuromodulation for female sexual dysfunction.~   "
5099|NCT03500133|"~     This trial proposes a therapy for pediatric Hodgkin lymphoma with the objective of achieving~     high levels of long lasting complete remission with less risk of late effects.~      Patients of both genders, between 2 and 18 years, with newly diagnosed classical Hodgkin~     lymphoma are admitted.~      Initial staging provides stratification in three groups: low, intermediate and high risk. An~     initial set of two chemotherapy courses is administered to all cases after which a new~     disease assessment is performed. According to disease response a final therapy group is~     assigned. Rapid early responders benefit from less chemotherapy. At the end of chemotherapy,~     radiotherapy is delivered only to patients who do not achieve a complete response. Thus~     therapy is tailored to initial extension and disease responsiveness. Complete responders at~     the end of chemotherapy do not receive radiotherapy. Those who are in partial remission~     receive low dose (30Gy) involved node radiotherapy. Stable or progressive disease at any~     moment is assumed as a trial failure and new therapeutic strategies are offered to patients~     off protocol.~      Chemotherapy is based upon regimes with well known effectiveness in Hodgkin lymphoma. (i.e.~     ABVD: doxorubicin, bleomycin, vinblastine and dacarbazine and ESHAP: Etoposide, methyl~     prednisolone, citarabine and cisplatin). The schedules are delivered with low cumulative drug~     doses and avoiding the use of toxic alkylating agents. Risks of secondary leukemia and~     infertility are thus minimized. Doxorubicin and bleomycin do not achieve cumulative doses~     that may expose to significant risk of heart or lung damage. Radiotherapy reduction avoids~     late radiation sequels.~      This clinical study proposes a therapeutic approach based on chemotherapy that do not sum up~     high cumulative toxic doses. Therapy is tailored according to initial risk assessment and~     disease responsiveness. Those who achieve a complete response to chemotherapy do not receive~     additional radiotherapy, thus avoiding further late effects.~   "
26510|NCT03219983|"~     The purpose of the study is to determine if pain management after total shoulder arthroplasty~     is more efficacious with ultrasound guided, continuous Interscalene block or with local~     tissue infiltration with liposomal bupivacaine.~      Traditionally, general anesthesia followed by narcotics has been the primary management of~     pain control. However, regional anesthesia in the form of an interscalene block (ISB), a~     perineural local anesthetic infusion, is commonly used and may more effectively control pain~     during and after shoulder arthroplasty, with fewer side effects than narcotics.~     Intraoperative benefits include better control of blood pressure and reduced need for general~     anesthesia and narcotics. Depending on the type of block (single shot vs. continuous) and the~     type of local anesthetic administered, pain relief may persist for 12-96 hours~     postoperatively.~      However, not all patients are candidates for peripheral nerve blocks. Pre-existing pulmonary~     disease, previous neck surgery, cervical arthritis, neurologic disorders and obesity may~     preclude ISB placement. As well, interscalene blocks are not completely benign procedures.~     Systemic complications include clinically significant intraoperative hypotension,~     pneumothorax, vascular injury, cardiac arrest, respiratory failure, seizure and death.~     Phrenic nerve paralysis is common, although transient. Peripheral nerve injuries related to~     mechanical injury, medication neurotoxicity, compression or ischemia are infrequent but may~     be devastating. The experience and number of blocks performed by the anesthesiologist in~     addition to adjunctive tools, such as ultrasound and/or nerve stimulators, impacts the~     success of the procedure.~      Continuous indwelling interscalene blocks (CISB) may provide substantial and longer pain~     relief, precluding the need for perioperative narcotics. Earlier discharge post procedure and~     better early range of motion are other purported benefits. However, premature catheter~     failure, catheter breakage, infection, over administration of medication and extended~     diaphragmatic paresis are concerns. In addition, there is a cost associated with these~     procedures. The anesthesiologist fee, catheter with or without elastomeric pump, local~     anesthetic, perioperative patient evaluation and treatment of any associated complications~     all must be considered.~      . The development of new, long acting local anesthetics, such as liposomal bupivacaine, is~     potentially important in the management of perioperative pain. Liposomal bupivacaine has been~     approved by the US Food and Drug Administration for local infiltration for pain relief after~     bunionectomy and hemorrhoidectomy. This preparation increases the duration of local~     anesthetic action by slow release from the liposome and delays the peak plasma concentration~     when compared to plain bupivacaine administration. Studies have shown it to be an effective~     tool for postoperative pain relief with opioid sparing effects and it has also been found to~     have an acceptable adverse effect profile.~   "
5101|NCT03500107|"~     Bacterial Vaginosis (BV) is a infectious process of the female genitourinary tract, an~     important health issue due to the high incidence and high rate of recurrence of the~     infection. Therefore, new therapeutic modalities are sought with the capacity to minimize~     drug side effects and reduce cases of recurrence of the disease. The objective of this study~     is to evaluate the clinical and microbiological responde of the 401+/- 5nm blue light~     emitting diode (LED) in the treatment of women with bacterial vaginosis. The group of women~     with diagnosis of bacterial vaginosis will be submitted to the light therapy. These women~     will also be submitted to an evaluation and examination by a ginecologist before and after~     the therapy. There will also be an evaluation of the clinical condition and about the effects~     of the light through the questionnaire answered before and after participant's treatment.~     It's expected that the 41 +/- 5nm LED will destroy the VB demonstrated by laboratory~     examination and also improves the signs and results analyzed by the gynecologist and~     participants.~   "
5102|NCT03500094|"~     This is an open-label study to evaluate the safety, pharmacokinetics, pharmacodynamics, and~     efficacy of migalastat treatment in pediatric subjects 12 to <18 years of age with Fabry~     disease and amenable GLA mutations.~   "
5103|NCT03500081|"~     The use of MRI imaging and image fusion in radiation therapy has dramatically increased~     during the past decade. However, the existing MRI-imaging protocols, imaging software and~     pulse sequences are all optimized for diagnostic purposes. With the introduction of the~     MR-linac, there is a critical and imminent need to develop imaging protocols that build and~     adapt the existing imaging parameters within the scope of the FDA-approved software to~     acquire MRI images that have less geometric distortion and better spatial resolution.~   "
5104|NCT03500068|"~     Rationale: Pancreatic adenocarcinoma is a malignancy with a poor prognosis. Resection is the~     only curative option and still 5-year survival rate is less than 10 percent. However, most~     patients present with advanced disease and are provided with palliative care. The nature of~     the tumour and the intense stromal reaction around the tumour cells leave pancreatic~     adenocarcinoma relatively insensitive to chemotherapeutics. Current models, such as cell~     lines or patient derived xenografts, cannot provide predictive information in a clinically~     relevant timeframe. Organoids and organotypic culture systems have emerged as promising new~     culturing techniques that maintain some of the complexity of the tumour. As most patients are~     ineligible for tumour resection, this project will focus on metastases and will generate~     organoids from that tissue. Using a combination of organoids and organotypic systems,~     treatment (non)response can be predicted, which may provide a personalized treatment setting~     for patients with advanced pancreatic adenocarcinoma.~   "
5105|NCT03500055|"~     This study is a single center, randomized controlled trial investigating the use of an~     abdominal closure bundle to reduce surgical site infection in patients undergoing cesarean~     section. The abdominal closure bundle consists of surgeon repeat scrub, changing gown and~     gloves, as well as usage of new instruments for closure of fascia, subcutaneous tissue, and~     skin. Patients will be randomized to either abdominal closure bundle or normal operative~     procedure. Primary outcome is surgical site infection within 30 days of procedure.~   "
5106|NCT03500042|"~     Chronic Obstructive Pulmonary Disease (COPD) is a chronic respiratory disease characterized~     by persistent airflow limitation. The patients are suffering dyspnea year by year, resulting~     in the decreased exercise tolerance and quality of life. Patients with COPD often have both~     inspiratory muscles and expiratory muscle dysfunction. Respiratory muscle training was one of~     the widely used pulmonary rehabilitation method in COPD patients. Respiratory muscle training~     include inspiratory training ,expiratory training and concurrent inspiratory and expiratory~     muscle training . Both of the training methods are effective. However, the effects of these~     different types of respiratory muscle training method on the respiratory physiology and~     neural respiratory drive of COPD are still unclear. Therefore, the purpose of this study was~     to investigate the different effects of these respiratory muscle training methods on~     respiratory mechanics and central drive in COPD patients. Besides,the effect of the different~     respiratory muscle training methods was compared between patients with and without~     respiratory muscle weakness.~   "
5107|NCT03500029|"~     Depression is the most common psychiatric condition and a important public health concern in~     society. But medications for depression don't work as well as people expected and cause~     serious side-effects. Transcranial magnetic stimulation (TMS) is a noninvasive electrical~     stimulation treatment for depression, which has been approved by the FDA and added to the~     Guidelines for the Treatment of Depression in China. Despite the effect of the treatment is~     clear ,the TMS target,the neural circuit which plays a role in TMS and its mechanism remain~     unknown now. TBS target and effective site may be not in the same position. A large number of~     previous studies demonstrate the advantages and application prospects of different techniques~     of magnetic resonance (MR)in the study of pathogenesis of depression. Based on the results of~     previous research supported by the National Natural Science Foundation of China,the National~     Key Technology Research and Development Program of China during the 10th Five-Year Plan and~     New Health Care and New technology. project team puts forward the idea of joint use of brain~     structure imaging of MR ,Diffusion Tensor Imaging (DTI) and resting-state functional MRI~     (fMRI) with different analysis methods to conduct a comprehensive study. The study is focused~     on the effects of TBS treatment on brain structure network, fiber connectivity network and~     functional connectivity network ,and nodes affected by it. Then we make further investigation~     about the mechanism of TMS treatment. The research will provide not only help for studying~     the pathogenesis of depression but also more reliable targets of next TMS treatment.~   "
5116|NCT03499912|"~     1. To assess the incidence of IDH1 and IDH2 mutations in adult AML patients, and to explore~          their associations with the patients' clinical, cytogenetic, and molecular~          characteristics as well as with treatment response and outcome.~        2. To delineate the similarities and distinctions among mutations at IDH1-R132, IDH2-R140~          and IDH2-R172 in AML, both clinically and molecularly (including cytogenetics,~          immunophenotyping, mutation co-occurrence patterns).~        3. The results can be references for future selection of targeted therapy (targeting IDH~          mutant proteins).~   "
5582|NCT03493802|"~     The purpose of this study is to determine whether patients with autosomal dominant polycystic~     kidney disease (ADPKD) present with abnormal endothelial function, increased levels of NOX4~     activity and mitochondrial abnormalities, contributing to oxidative stress from early stages~     that correlate with disease severity.~   "
5108|NCT03500016|"~     Type 2 diabetes are characterized by insulin resistance in skeletal muscle. Insulin~     resistance plays a major role for the increased risk of heart disease seen in type 2~     diabetes. No specific treatment of insulin resistance is currently available, except from~     increased physical activity and weight-loss.~      Insulin resistance is characterized by abnormalities in the use of glucose and fat in the~     muscle, and is associated with abnormal function and content of mitochondria (the power~     houses of our cells) as well as increased levels of fat within the muscle.~      The investigators believe that abnormalities in the use of glucose and fat in muscle cells in~     response to insulin and exercise can explain why insulin resistance is associated with~     abnormal function and content of mitochondria and an increased amount of fat in skeletal~     muscle of patients with type 2 diabetes and individuals with obesity. The major purpose of~     our project is, therefore, to investigate the effect of insulin in physiological~     concentrations and the effect of both acute exercise and 8 weeks of exercise-training on~        1. insulin sensitivity and energy metabolism,~        2. insulin signaling,~        3. mitochondrial dynamics and mitophagy,~        4. regulators of storage of fat into lipid droplets and their interaction with mitochondria~          in skeletal muscle~        5. acetylation and phosphorylation of enzymes (proteins) in major metabolic and signaling~          pathways, as well as~        6. transcriptional and signalling networks regulating mitochondrial biogenesis and~          substrate metabolism.~      The effects of insulin in physiological concentrations and novel exercise-interventions~     combining biking and rowing will be studied in a comprehensive study of obese patients with~     type 2 diabetes compared with weight-matched obese and lean healthy controls.~      The effects of insulin and exercise on whole-body metabolism will be evaluated by measurement~     of maximal oxygen consumption, and well-known methods to determine insulin-stimulated glucose~     utilization and use of glucose and fat. Skeletal muscle and fat tissue samples obtained under~     these conditions will be used for assessment of tissue-levels of specific sets of genes and~     enzymes known to be involved in insulin action, quality and size of mitochondria, and storage~     of fat into lipid droplets and their interaction with mitochondria. This project is expected~     to provide important and novel insight into the causal relationship between insulin~     resistance, accumulation of fat and abnormal content and function of mitochondria in skeletal~     muscle in type 2 diabetes.~      The investigators ultimately expect that our findings will help us to identify novel~     molecules or enzymatic pathways, which can be used to develop drugs that can enhance or mimic~     the effects of insulin and exercise, and hence be used in the prevention and treatment of~     type 2 diabetes and heart disease.~   "
5109|NCT03500003|"~     Despite the fact that dairy products are greatly consumed, it remains today very difficult to~     determine with a classical blood biochemical test whether a person has ingested a fresh~     fermented dairy product or just milk, while their biological, metabolic and health impacts~     may be different.~      The metabolic footprint left by the consumption of these products could be modified by the~     age of the consumer. Indeed, in the elderly, the processes of digestion, assimilation and~     metabolism are known to be altered /different compared to healthy adults. Thus, different~     metabolic signatures in the elderly could appear as the result of a less effective use and~     metabolism of the nutrients ingested. This could further also result in different or altered~     biological effects on dairy products.~   "
5110|NCT03499990|"~     Patients with adrenal insufficiency are at risk to suffer from life threatening adrenal~     crisis. The aim of this trial was to reevaluate the frequency of adrenal crisis and risk~     factors for crisis within a prospective study (six-years follow-up of a former prospective~     study).~   "
5111|NCT03499977|"~     Excessive sitting, or sedentary behaviour (SB), has been associated with numerous detrimental~     health outcomes and chronic diseases. Given the sedentary lifestyle of university students~     and occupational workers, interventions aimed at reducing SB are becoming increasingly~     important. Previous research has shown positive health benefits associated with frequent~     breaks in prolonged SB. However, it is unclear what the effect of different types of activity~     breaks have on work-related mental skills and performance. Recent literature has provided~     evidence that a 10-minute bout of moderate-intensity physical activity (PA) can improve these~     mental skills. However, this intensity of exercise may be inappropriate or unfeasible for~     these populations. Hence, it is important to determine if lower intensity activities can~     elicit similar benefits to work-related mental skills.~   "
5112|NCT03499964|"~     ROBUST III is a prospective, multi-center, randomized controlled adaptive sample size~     clinical trial to establish the safety and effectiveness for the Optilume Stricture Drug~     Coated Balloon (DCB).~   "
5113|NCT03499951|"~     The objective of the study is to evaluate the effectiveness of remote training to teach~     clinicians how to train others in wheelchair skills.~   "
5114|NCT03499938|"~     Obstructive airways disease is the most common group of acute illnesses leading to hospital~     treatment in children. This group consists of different age-related diagnoses, such as~     bronchiolitis in infants or wheezing and asthma in older children. Though these entities~     overlap with each other, they have common characteristics and the same leading symptom~     breathing distress.~      The investigators aim conduct an observational cohort study to examine if the clinical course~     of respiratory distress be quantified and the treatment improved in children with acute~     breathing difficulty using a new non-touch non-invasive SLP measurement device?~      Thora3Di is a new CE- and FDA-approved medical device able to measure chest and abdominal~     wall movements during tidal breathing with a method called structured light plethysmography~     (SLP). The method is non-touch and non- invasive, it does not need any connection with the~     child.~      One-month- to 12-years-old infants and children are recruited from the paediatric wards at~     Evelina London Children's hospital. The child lies or sits within the field of vision of the~     SLP device with their chest and abdomen exposed. A grid pattern of normal light will be~     projected onto the chest and changes in the format of the grid as the infant or child~     breathes will be recorded by the SLP device. Data will be collected for each child for 3-5~     minutes once in 24 hour periods for 2-10 times during hospital stay.~      The aim is to reduce duration of hospital stay by finding predicting parameters for~     obstructive airways diseases with the new SLP method, and further aim to standardization of~     treatment strategies, to reduce expenditure.~   "
5115|NCT03499925|"~     Few reports have addressed mental health for women with pregnancy complication over a~     prolonged time period. Meanwhile, the caring model with intervention for women who have~     pregnancy complication needs to be developed. The aims of this study are to (1) describe and~     compare the differences in health indicators during pre-pregnancy, pregnancy and 1 year~     postpartum; (2) develop the theoretical framework of relationship among health indicators~     during perinatal period; (3) develop a telephone follow-up and consultation program and~     examine its effect on women's resilience, depression, anxiety and quality of life. In the~     first stage, a prospective longitudinal investigation will be performed in women at pregnancy~     and postpartum. Women with pregnancy-related complications will be recruited. All~     participants will complete questionnaires that assess demographic characteristics, obstetric~     and birth history, depression, anxiety, resilience and quality of life. Participants who are~     in early, middle, late pregnancy, 3-5 days, 1st, 3rd, and 6th month and 1 year postpartum~     will be contacted to complete the questionnaires by mail or at study site clinics. The sample~     size was estimated by drop rates and power calculation. Approximately 380 women in early~     pregnancy will be recruited at a medical center in northern Taiwan. The first stage of this~     study will be conducted over a 3-year period. In the second stage, randomized control trial~     with single blind will be used to recruit eligible subjects from women in the waiting room~     for prenatal examination at a medical center in Taipei. The eligible subjects will be~     randomized into a control or experimental group. The women in the control group will receive~     usual care and those in the experimental group will receive four instances of telephone~     follow-up or face-to-face consultation. Two groups will receive 3 times measurements of~     depressive symptom, anxiety, resilience and quality of life. Meanwhile, Investigators will~     assess the health indicators of women's newborn. Data will be analyzed by independent t-test~     and generalized estimating equations. Forty-eight subjects will be recruited in each group.~     Totally, 300 subjects will be approached in terms of including a 30% dropout rate. The second~     stage of this study will be conducted over a 2-year period.~   "
9978|NCT03436212|"~     This study aims at describing the glucose level by automated glucose sensors and correlating~     it with insulin delivery and meals over 14 days in insulin-requiring T2D patients living in~     real-life conditions.~   "
5117|NCT03499899|"~     The purpose of this study is to assess the efficacy, safety, and PK characteristics of the~     following three combinations: i) LAG525 + spartalizumab; ii) LAG525 + spartalizumab +~     carboplatin, and iii) LAG525 + carboplatin in subjects with metastatic TNBC and up to one~     prior line of systemic treatment for metastatic disease. A thorough biomarker strategy to~     address key aspects of tumor immunogenicity will be implemented in the study.~      LAG525 and spartalizumab are two immuno-agents targeting different immune checkpoints, and~     have been tested as single agents and in combination. To further enhance the efficacy of~     checkpoint inhibition, carboplatin will be given with LAG525 or with LAG525 and~     spartalizumab, based on the observation that the addition of chemotherapy can change the~     tumor microenvironment to be more favorable to immune response.~   "
5118|NCT03499886|"~     Abstract Background: Ketamine has been introduced as one of the most common drugs,~     administered to sedate children for different painful procedures in the emergency department~     (ED) but administration in higher dosage causes some severe complications. Thus, the aim of~     this study was to evaluate the effect of low-dose intravenous ketamine bolus versus~     conventional injection for reduction of upper and lower extremity fractures in children.~      Materials and Methods: In this randomized clinical trial, 198 participants with upper and~     lower extremity fractures were enrolled. The participants were divided randomly into two~     groups. In the intervention group, ketamine 1% was administered rapidly at a dose of 0.5 mg /~     kg (within 5 seconds), and in the control group, ketamine 1.5 mg / kg was slowly injected for~     30 to 60 seconds. Then outcomes such as sedation depth and complications were measured for~     every two minutes and satisfaction of participants and physicians were recorded.~      Results: Results showed that the successful sedation rate in the low dose ketamine group was~     significantly lower, as compared to the control group (7% vs 100%) (p<0.001). Moreover, In~     terms of duration of drug effect and of recovery, the low dose ketamine group were~     significantly lower compared with the group receiving higher dosage of ketamine (p<0.05).~     Furthermore, the sedation depth based on Wisconsin Sedation Scale was significantly higher,~     in the low dose ketamine group compared to the other group. By evaluating different~     complications, we found that the rate of neurological (20.4 % vs 5%) and physiological (10.2%~     vs 2%) complications in the control group was significantly higher compared to the group~     receiving low-dose ketamine (p<0.05).~   "
5119|NCT03499873|"~     A randomized, multicenter, double masked, placebo controlled, parallel group, bioequivalence~     study to evaluate the clinical equivalence and safety of Nepafenac 0.3% ophthalmic suspension~     (manufactured by Indoco remedies Ltd. for Actavis LLC) with IlevroTM (Nepafenac ophthalmic~     suspension), 0.3% of Alcon Laboratories, Inc. for the treatment of pain and inflammation~     associated with cataract surgery.~   "
5120|NCT03499860|"~     The aim of the study is to evaluate whether changes in Perfusion Index (PI) and Pleth~     Variability Index (PVI) during passive leg raising test can predict fluid responsiveness in~     spontaneously breathing patients.~      Fluid responsive patients are defined as showing an increase in cardiac output >10% during a~     passive leg raising test, measured semi-invaseively with FloTrac® (Edwards LifeSciences.~     Irvine, United States).~   "
5121|NCT03499847|"~     An Advanced Medical Directive (AMD) is a legal document in Singapore that allows one to~     inform their medical practitioner that they do not want any life-sustaining treatment should~     they become unconscious and terminally ill where death is imminent. Despite the AMD act being~     passed in Singapore Parliament in 1996, uptake remains low among the population. Several~     intervention studies have shown that education and communication can be effective in~     promoting end-of-life discussion and planning. In this study, we aim to compare the~     effectiveness of counselling sessions together with pamphlets, versus pamphlets alone, versus~     current care, in increasing the completion rates of the AMD in the Singapore Polyclinic~     setting.~   "
5122|NCT03499834|"~     In this study, whole blood is drawn from the patient to be used to grow Immune Killer Cells~     (IKC). After proliferation, the IKC will be infused back into the patient to treat the cancer~     for a total of 24 weekly treatments.~      Possible adverse reaction can include slight fever and headache.~   "
5123|NCT03499821|"~     This study will evaluate the clinical performance of a phakic intraocular lens (IOL) for the~     improvement of Uncorrected Near Visual Acuity (UCNVA) in subjects who require between +1.00~     and +2.50 Reading Add.~   "
5124|NCT03499808|"~     This phase II trial studies how well isatuximab works in treating patients with primary~     amyloidosis that has come back or does not respond to treatment. Monoclonal antibodies, such~     as isatuximab, may interfere with the ability of cancer cells to grow and spread.~   "
5125|NCT03499795|"~     This is a phase 2, open-label efficacy study of VGX-3100 administered by intramuscular (IM)~     injection followed by electroporation (EP) in adult men and women who are human~     immunodeficiency virus (HIV) negative with histologically confirmed anal or anal/peri-anal~     high-grade squamous intraepithelial lesion (HSIL) associated with human papilloma virus~     (HPV)-16 and/or HPV-18. Approximately 24 participants will receive at least 3 doses of~     VGX-3100.~   "
5126|NCT03499782|"~     Malignant tumors of biliary system lack standard treatment and precise prognosis assessment~     methods. This study including 12 hospitals, collecting clinical and follow-up data of~     patients with biliary malignant tumors including cholangiocarcinoma and gallbladder carcinoma~     in recent 10 years, aim to build a special disease database, then use Bayesian networks and~     importance theory to establish a mathematical model to assess treatment strategies and~     prognosis accurately. At the same time, data on biliary malignant tumors newly treated by~     multicenters from 2018 to 2020 will be included to validate, adjust and refine the models to~     guide clinical individualized precise treatment.~   "
5127|NCT03499769|"~     Laparoscopic total colectomy (LTC) is an accepted surgical procedure for several colonic~     pathologies. Additionally, specimen extraction through the natural orifices is an emerging~     method when combined with the totally laparoscopic procedures. Our observations on natural~     orifice surgery was promising . In our daily surgical practice, investigators prefer the~     intracorporeal anastomosis and this study was conducted to compare the specimen extraction~     sites after LTC. Here investigators aimed to compare the results of conventional and natural~     orifice specimen extractions (NOSE) after totally LTCs.~   "
5635|NCT03493113|"~     The aim of this study is to investigate differences in electroencephalography (EEG) evolution~     between preterm infants with and without transient hypothyroxinemia of prematurity (THOP) in~     order to find differences in the interburst interval and the background pattern and in the~     maturation of the sleep-wake cycle.~   "
5133|NCT03499691|"~     Today it is well established that middle molecules comprise several compounds that are not~     effectively removed by high-flux dialyzers, and effective clearance of large middle molecules~     in the process of dialysis depends on the dialyzer membrane having large enough pore sizes,~     larger than the conventional high-flux dialyzers. Studies have found associations between~     levels of large middle molecule uremic toxins and immune dysfunction and inflammation, as~     well as adverse outcomes. This indicates that dialysis membranes having larger pores,~     enabling an expanded HD (HDx) with more effective removal of large middle molecules, can have~     a positive impact on the inflammatory state. While data is starting to appear on the~     long-term use of the HDx therapy, little is still known on how large middle molecules and~     inflammation markers are affected over time.~   "
5134|NCT03499678|"~     A central challenge in the fight against lung cancers is how to detect disease in a~     noninvasive manner before it is detectable by imaging methods. Although inroads have been~     made with more sensitive imaging techniques for earlier detection of breast and lung cancers,~     these techniques are limited by the size of lesion that could be detected. Alternatively,~     several blood proteomic biomarkers have been proposed but none offer as of yet sufficient~     predictive power. Consequently, effective non-invasive tools as prognostic indicators and~     biomarkers of lung cancer is urgently needed.~      The purpose of this study is to develop and test non-invasive biomarkers based on methylation~     changes in PBMC and circulated tumor DNA in lung cancer patients.~   "
5135|NCT03499665|"~     This study was planned to evaluate the effects of proprioceptive neuromuscular facilitation,~     myofascial releasing maneuvers and home exercises on pain and jaw function in patients with~     bruxism aged 16-50 years .~   "
5136|NCT03499652|"~     Neonatal bacterial meningitis (BM) is a devastating infection that occurs more commonly in~     neonates than in any other age group, and is associated with significant morbidity and~     mortality, especially in developing countries. In this study, we aimed to develop a clinical~     risk score model, according to the available clinical syndromes and commonly laboratory~     tests, for screening BM among full-term neonates in a large-scale retrospective cohort, and~     prospectively validated the risk score in multicenter cohort.~   "
5137|NCT03499639|"~     Management of patients with hepatitis C virus (HCV) related liver disease with concomitant~     co-morbidity was challenging, especially in the period before the era of new direct-acting~     antiviral (DAA) agents. With the introduction of DAAs protocols, the therapeutic options were~     expanded to endorse many patients that were previously assigned as difficult-to-treat~     population. Different situations were encountered with co-infection with HCV such as chronic~     kidney disease (CKD) with its spectrum from mild forms to the end-stage kidney disease~     (ESKD), patients on hemodialysis (HD), and in post-renal transplant settings. Till now,~     pooled data about the safety and efficacy of different DAAs regimens in different renal~     situations are still under evaluation, especially in Egypt, where HCV genotype 4 the most~     dominating genotype. In Egypt, there were two adopted protocols for patients with HCV and~     CKD; the sofosbuvir-based combinations and the ombitasvir, paritaprevir, and ritonavir plus~     ribavirin-based combination. Sofosbuvir was proved to be contraindicated in patients with~     end-stage renal diseases as its elimination based mainly on renal route that may affect its~     bioavailability. On the other hand, ombitasvir, paritaprevir, and ritonavir plus ribavirin~     regimen was proved to be a well-tolerated protocol in non-cirrhotic patients with CKD.~   "
5138|NCT03499626|"~     This is a single-arm, allocation open label study. Phase 1 is a dose-finding phase in~     patients with advanced/ metastatic hepatocellular carcinoma (HCC) who have progressed on~     first line Sorafenib or Lenvatinib.~      The primary objective of this study will be to establish the maximal tolerable dose (MTD) of~     ASLAN001 (Varlitinib) in the study population~      The secondary objectives include:~        1. To evaluate the efficacy of ASLAN001 (Varlitinib), as measured by duration of response~          (DoR), progression free survival (PFS), overall survival (OS) and disease control rate~          (DCR)~        2. To assess the ORR, DoR, PFS, DCR and OS by tumor EGFR/HER2/HER3/HER4 status~        3. To identify tumor and host biomarkers predictive of treatment response or toxicity to~          ASLAN001.~   "
5139|NCT03499613|"~     Chronic low back pain (CLBP) is one of the most frequent causes for limitations in daily,~     leisure and work-related activities. Although alterations in spinal motor behavior were~     consistently reported in CLBP patients, it remains unclear how improvements in spinal motor~     behavior through rehabilitation treatment affect pain and disability. Psychological factors,~     such as pain-related fear, were suggested as a possible main cause of spinal motor behavior~     in CLBP and better understanding their relationships with kinematic and muscle activity~     alterations is required to enhance care, particularly physiotherapy. Therefore, this study~     will test CLBP patients before and after a 3 week rehabilitation program to test the~     hypotheses that: 1) improvements in spinal motor behavior (kinematics and trunk muscle~     activity) are associated with decreased pain and disability; 2) decrease in pain-related fear~     is associated with spinal motor behavior improvements.~   "
5140|NCT03499600|"~     The project at the center of this proposal will leverage a pilot randomized design to examine~     initial feasibility and preliminary effects of augmenting usual mental health evaluation~     procedures with a structured person-centered assessment tool that specifically considers the~     cultural context of patient mental health problems (i.e., the Cultural Formulation Interview;~     CFI) on parent satisfaction, engagement and clinical child outcomes in the treatment of early~     child behavior problems. Additional analyses will explore whether traditional barriers (e.g.,~     stigma, ethnic identity, and daily stress) moderate the effects of the CFI on satisfaction,~     engagement and treatment outcomes.~   "
5141|NCT03499587|"~     The goal of this study is to see if there are negative effects of maternal obesity during~     pregnancy on offspring's brain development.~   "
5142|NCT03499574|"~     This study will investigate the feasibility of delivering swallowing therapy using surface~     electromyography as a means of biofeedback to patients with dysphagia in the acute stroke~     setting. It will investigate trends in efficacy by comparing biofeedback therapy to usual~     care. The results will inform future dosing and efficacy studies.~   "
5143|NCT03499561|"~     Asymptomatic bacteriuria (ASB) is defined as the presence of at least 105 colony-forming~     units (CFU)/ml of 1 or 2 bacterial species in clean-voided midstream urine sample from an~     individual without symptoms of UTI~   "
5144|NCT03499548|"~     This study aims to assess the acceptability and feasibility of a short-term, intensive~     Cognitive Behavioural Therapy (CBT) delivered to male prisoners who have thoughts of ending~     their lives.~   "
5145|NCT03499535|"~     Despite a push for tailored messages, health communications are often aimed at, and viewed~     by, people with varying levels of risk. This project examined—in the context of radon risk~     messages—whether information relevant to high-risk individuals can have an unintended~     influence on lower-risk individuals. Specifically, the investigators assessed whether~     information about lung-cancer risk from smoking reduced concerns about lung-cancer risk from~     radon among nonsmokers. The investigators hypothesized that non-smokers who read a message~     that included smoking-relevant information would express less concern about the effects of~     radon exposure and less interest in testing their home compared to those who read a version~     in which smoking-relevant information was excluded. Two studies were conducted. Although the~     investigators did not exclude smokers, the focus was on participants self-identifying as~     nonsmokers (including never smokers and former smokers).~   "
5146|NCT03499522|"~     Introduction. The development of joint hemorrhages in patients with congenital coagulopathies~     favor the development of an intra-articular, degenerative and progressive lesion (hemophilic~     arthropathy). Pain is one of the main clinical manifestations of hemophilic arthropathy and~     is related to the development of disability and a worse quality of life.~      Objective. Observe the characteristics of pain, coping models and the perception of quality~     of life in patients with congenital coagulopathies.~      Study design. Observational, cross-sectional and multi-center study. Method. 80 patients with~     congenital coagulopathies (hemophilia A and B, and von Willebrand's disease), of legal age,~     will be included in the study. Patients will be recruited in six centers, from different~     regions of Spain. The study variables and measurement instruments used will be: pain~     perception (numerical pain scale, Tampa Scale of kinesiophobia and Pain Catastrophizing~     Scale); perception of quality of life (Short Form -36 questionnaires); anxiety (State-Trait~     Anxiety Questionnaire); coping strategies (Coping Strategy Questionnaire); and disease~     perception (Illness behaviour questionnaire and Revised Illness Perception Questionnaire). A~     descriptive statistical analysis of the dependent and independent variables will be carried~     out. In the same way, the correlations between the variables and the characteristics of the~     subjects will be analyzed according to age, the type of coagulopathy and the degree of~     sequelae.~      Expected results. Observe the characteristics of pain, its coping models and its implication~     in the quality of life in patients with congenital coagulopathies, and evaluate the~     independent variables related to the perception of pain.~   "
5147|NCT03499509|"~     The Scientific Premise of this study is that the high level of obesity displayed by African~     American (AA) women is due to the ability to secrete large amounts of insulin when sugary~     foods are consumed. When AA women eat a diet rich in starchy or sugary food (a~     high-glycemic diet that stimulates insulin secretion), the food that is eaten is stored as~     fat rather than being burned as fuel. The investigators previous research has suggested that~     AA women have an easier time losing weight and keeping it off when eating a low-glycemic~     diet. The proposed study will be the first randomized clinical trial to test the effect of~     high and low glycemic diets for weight loss and weight-loss-maintenance in obese AA women.~   "
5148|NCT03499496|"~     Cardiovascular disease is a common diagnosed and treated condition in private practices of~     primary health care. There is growing evidence that atherosclerotic plaques as predictors for~     stroke and heart attack are more prevalent than expected based on the clinical score in~     people with low risk for stroke and heart attack .~      Diagnosing atherosclerotic plaques can help to decide if a lipid lowering therapy should be~     prescribed even if the clinical risk score is low or on the other hand if they can be~     observed even in high lipid levels.~   "
5149|NCT03499483|"~     Study will evaluate the safety and tolerability of once daily Biktarvy for 28 days for~     prevention of HIV infection in HIV-1-seronegative adults after high-risk sexual contact.~     (non-occupational post exposure prophylaxis - nPEP)~   "
5150|NCT03499470|"~     Readmission to hospital is one of the most important problems in chronic obstructive~     pulmonary disease (COPD) patients who developed chronic respiratory failure. Patients~     receiving long-term oxygen therapy (LTOT) and noninvasive ventilation (NIV) constitute the~     most vulnerable group because of the need for comprehensive care. However, because of lack of~     health care support systems in Turkey, many advanced COPD patients are hospitalized due to~     preventable problems such as insufficient knowledge about the therapies, nonadherence to~     therapy and technical issues related to LTOT/NIV equipment. The aim of this multicenter~     randomized trial is to find out whether a structured discharge and follow-up protocol reduce~     the rate of unplanned, COPD-related hospital readmissions over 90 days in patients receiving~     LTOT or NIV.~   "
5151|NCT03499457|"~     revising penicillin allergy in the medical records, by taking full medical history and giving~     a challange test, in order to imrove the medical records and treatment possibilities.~   "
5152|NCT03499444|"~     This is a Phase 1 open-label, dose-escalation, safety and pharmacokinetic study of rucaparib~     administered twice daily (BID) to Japanese patients with a solid tumor who have failed~     previous standard treatment for their cancer. A recommended dose of rucaparib for Japanese~     patients will be determined in a dose-escalation portion and then further evaluated in a~     dose-expansion portion of the study.~   "
5153|NCT03499431|"~     The purpose of this study is to evaluate the long-term safety and performance of complex~     endovascular aneurysm repair by inclusion in a longitudinal registry~   "
5154|NCT03499418|"~     Transient Tachypnea of the Newborn (TTN) is one of the common causes of neonatal respiratory~     distress as a result of delayed clearance of fetal lung fluid.~      Neonates with TTN usually require noninvasive respiratory support (e.g. nasal cannula, nasal~     CPAP) and may need supplemental oxygen therapy to maintain normal oxygen saturation levels.~     There have also been reports of malignant TTN, in which affected children develop~     persistent pulmonary hypertension of the newborn (PPHN).~   "
5175|NCT03499145|"~     The prevention and treatment of diseases via artificial intelligence represents an ultimate~     goal in computational medicine. Application scenarios of the current medical algorithms are~     too simple to be generally applied to real-world complex clinical settings. Here, the~     investigators use deep learning and visionome technique, an novel annotation method for~     artificial intelligence in medical, to create an automatic detection and classification~     system for four key clinical scenarios: 1) mass screening, 2) comprehensive clinical triage,~     3) hyperfine diagnostic assessment, and 4) multi-path treatment planning. The investigator~     also establish a telemedicine system and conduct clinical trial and website-based study to~     validate its versatility.~   "
5155|NCT03499405|"~     Headstart (HS) is an early childhood education program for low-income children. Preliminary~     analyses of Hamilton County HS preschoolers with developmental concerns identified 26% with~     severe concern necessitating developmental testing, and only 47% followed-through when some~     developmental concern was identified. Those less likely to follow-through were African~     American or Hispanic, lived in larger families, or had asthma. Cultural and economic factors~     are known barriers to earlier diagnosis of children with developmental disabilities (DD)~     among African American, Hispanic and low-income children. Given that HS children are~     low-income and culturally diverse, preschoolers are likely to face barriers to early~     identification of DD and subsequently kindergarten readiness. Patient navigator programs are~     effective interventions for vulnerable populations to improve health care access, increase~     treatment adherence, enhance trust in health care systems, and reduce health care costs. A~     family (FN) intervention that is culturally-adapted to promote caregiver follow-through, and~     undergirded by HS's mission of kindergarten success may effectively increase caregiver~     adherence to developmental testing. The goal of this study is to develop and pilot test a FN~     intervention in HS that is executed by peer-to-peer navigators to improve adherence with~     developmental testing in high-risk preschoolers.~   "
5156|NCT03499392|"~     The World Health Organization (WHO) ranks headache among the top 20 causes of disability in~     the world.~      Primary headaches (with no known organic cause) account for 90% of these conditions. INSERM~     estimates that 15% of the general population is concerned. WHO estimates that 1.7-4% of the~     global adult population is affected by headache for at least 15 days a month. Headaches are~     disabling, for patients (pain, suffering, fatigue, unavailability ...) but also for society~     (socio-economic cost as frequent work stoppages and drug costs). They are a public health~     problem.~      In 2002, the High Authority of Health published its recommendations for the diagnosis and~     management of migraine patients. In addition, the French Society for Migraine and Headache~     Studies updated these recommendations in 2013. They are focused on the medical management~     offered by doctors and pharmacists. However, the professionals in daily contact with the~     subjects know that the dimension psychic plays an important role in the etiology of~     headaches.~   "
5157|NCT03499379|"~     Determine what kind of side effects women experience in the first year after they start using~     an intrauterine device.~   "
5158|NCT03499366|"~     The study is a follow-up study on children with acute flaccid paresis associated with~     enterovirus D68 infection. Only children living in Europe are eligible. The study aim is to~     clarify the outcome of the disease and investigate possible clinical correlation with~     outcome, including initial severity, demographic characteristics, treatment and MRI findings.~   "
5159|NCT03499353|"~     A PHASE 2, NON RANDOMIZED, OPEN LABEL, SINGLE ARM, MULTI CENTER STUDY OF TALAZOPARIB FOR~     NEOADJUVANT TREATMENT OF GERMLINE BRCA1/2 MUTATION PATIENTS WITH EARLY TRIPLE NEGATIVE BREAST~     CANCER~   "
5160|NCT03499340|"~     Pictorial cigarette warning labels (PWLs) are thought to increase risk knowledge, but~     experimental research has not examined PWLs' longer term effects on memory for health risks.~     In this study, adult smokers are repeatedly exposed to text-only vs. low arousal graphic vs.~     high arousal graphic warning labels paired with numeric risk information. This study will~     allow the investigators to assess the extent to which reactions to warnings remain consistent~     over time and influence smoking risk perceptions and quit intentions. The investigators will~     also assess the impact of graphic images on memory for smoking risk information presented in~     absolute (a smoker's lifetime risk of getting a smoking related disease) versus relative (a~     smoker's risk of getting a smoking related disease, compared to the risk of non-smokers)~     formats.~   "
5161|NCT03499327|"~     The interventional study will evaluate effectiveness and potential of a regularly consumption~     of wheat germ oil (UV treated) vs. wheat germ oil (UV untreated) to increase plasma vitamin D~     levels ín humans.~   "
5162|NCT03499314|"~     This is a randomized, double-blind pilot clinical trial to test a novel treatment approach to~     rehabilitate fine motor function in individuals living with progressive multiple sclerosis~     (MS) using anodal transcranial direct current stimulation (tDCS) to augment manual dexterity~     training. Treatment will be delivered to individuals at home using a state-of-the-art~     remotely supervised tele-rehabilitation protocol, a major advantage for patients with respect~     to ease of access, feasibility, reinforcement learning and minimal burden of in clinic study~     visit participation. Improvements in fine motor skill will be assessed at each remote session~     using a novel portable grip device that measures execution and adaptation or learning of~     fingertip forces during grasp, which is more sensitive than standard measures of hand~     function.~   "
5163|NCT03499301|"~     The rate of patients with chronic pain (CP) is 40% in patients with acute pain in emergency~     department (ED). Patients with CP come more frequently to ED than patients without CP.~     Reasons for their visit to ED are often in relation with this CP. Few studies have been~     interested to management modalities of these patients in ED. We are going to realize a~     prospective observational study in one center. Our hypothesis is that patients with chronic~     pain are less satisfied of ED management that patients without CP.~   "
5164|NCT03499288|"~     HCPs will complete questionnaires about their patients with Cerebral Palsy (CP) and invite~     parents/caregivers of these patients to fill in questionnaires as well. Questionnaires~     include questions on individualized treatment, nutritional profile and management, and~     patient characteristics.~   "
5165|NCT03499275|"~     The aims of this study are to determine whether neuromuscular stimulation (NMES) of the~     quadriceps muscle is acceptable to patients with Idiopathic Pulmonary Fibrosis (IPF) and~     staff and whether it can impact clinical and healthcare resource usage outcomes.~   "
5204|NCT03498755|"~     This pilot study aims to introduce three interventions directed toward mitigating anemia~     among women in Ghana, including: 1) multi-sectoral behavior change, 2) strengthening market~     engagement of fish processors, 3) improving fish smoking technology and practices. These~     interventions will be implemented among female fish processors, a population that represents~     a promising focal area for intervention within fisheries value chains, which have been~     identified as a uniquely promising sector for intervention to mitigate anemia among women.~     The investigators expect that the findings from this study will inform understanding of how~     best to design, implement, and evaluate interventions into fisheries and other animal-source~     food value chains in Ghana and across sub-Saharan Africa to address anemia and other~     nutritional and health concerns.~   "
5166|NCT03499262|"~     The Social ABCs is an evidence-based, developmentally informed, caregiver-mediated~     behavioural intervention for toddlers with suspected or confirmed Autism Spectrum Disorder~     (ASD). It is based on principles of Pivotal Response Treatment (PRT, grounded in Applied~     Behavioural Analysis), and responsive parenting. The two key targets of this program are~     functional verbal communication and positive caregiver-child affect sharing. This~     intervention takes place in the context of play and daily routines, and in all contexts is~     made to be fun.~      In both a pilot study and a recently completed randomized control trial, toddlers whose~     caregivers received training in the Social ABCs intervention showed significant gains in~     early language development (both responsivity and initiations), increased child smiling~     (mediated by parent smiling), and a trend toward increased social orienting (one important~     manifestation of social attention).~      In an effort to make the Social ABCs more feasible for community service providers to provide~     this intervention to higher number families, an abbreviated version of the Social ABCs~     intervention is being offered in a mixed group/individual format in a clinic setting. The~     primary goal of this pilot project is to assess feasibility of this abbreviated program in~     the novel format and setting. The secondary goal is to train clinical service providers to~     facilitate this intervention, thus introducing the program into community practice.~   "
5167|NCT03499249|"~     Biliary atresia (BA) is a devastating liver disease of infancy, characterized by bile duct~     obstruction leading to liver fibrosis, cirrhosis, and eventual need for transplantation in~     most cases. BA is treated with Kasai portoenterostomy (KP). KPs can achieve bile drainage and~     improve outcomes. However, even with standard evidence of good bile flow, bile flow rarely~     normalizes completely and liver disease continues to progress.~      In this study, the investigators test whether intravenous N-acetylcysteine (NAC) can improve~     bile flow after KP. The rationale is that NAC leads to synthesis of glutathione, which is a~     powerful stimulator of bile flow. The primary objective is to determine whether NAC~     normalizes total serum bile acid (TSBA) concentrations within 24 weeks of KP. Achieving~     normal TSBAs is uncommon with current standard-of-care, and is predicted to be associated~     with better long-term outcomes. The secondary objectives are to describe how other parameters~     commonly followed in BA change with NAC therapy, as well as report adverse events occurring~     with therapy and in the first two years of life. This study follows the minimax Phase 2~     clinical trial design.~   "
5168|NCT03499236|"~     The objective of the RELIEVE-HF study is to provide reasonable assurance of safety and~     effectiveness of the V-Wave Interatrial Shunt System by improving meaningful clinical~     outcomes in patients with New York Heart Association (NYHA) functional class III or~     ambulatory class IV heart failure (HF), irrespective of left ventricular ejection fraction,~     who at baseline are treated with guideline-directed drug and device therapies.~   "
5169|NCT03499223|"~     This study is conducted to evaluate the safety of intravitreal THR-317 administered in~     combination with ranibizumab, and to assess the efficacy of the combination treatment in~     improving best-corrected visual acuity (BCVA) and reducing central subfield thickness (CST),~     in subjects with central-involved diabetic macular oedema (CI-DME).~   "
5170|NCT03499210|"~     A multi-site, interventional, non-comparative, single-arm trial to evaluate the safety of the~     ReWalk ReStore device in subjects with hemiplegia/hemiparesis due to ischemic or hemorrhagic~     stroke.~   "
5171|NCT03499197|"~     The cardiac allograft rejection (CAR) and cardiac allograft vasculopathy (CAV) significantly~     affect the prognosis of patients after heart transplantation. The aim of the present study is~     to investigate and differentiate the adaptive and pathological cardiovascular changes after~     heart transplantation using different modalities. The investigator's main purpose is to~     define the role of the cardiovascular imaging methods and biomarkers in the early diagnosis~     of CAR and CAV.~   "
5172|NCT03499184|"~     This study will assess clinical and microbiological efficacy of probiotics and antibiotics in~     patients of chronic periodontitis as an adjunctive to scaling and root planing (SRP) in~     reducing bacterial count and in improving clinical periodontal parameters over the period of~     12 weeks.Also the comparison between these adjunctives will be made for clinical assessment~     clinical periodontal parameters will be taken .these parameters plaque index (PI), gingival~     index (GI), clinical attachment loss (CAL) and pocket probing depth (PPD) for microbiological~     assessment plaque sample will be taken, DNA will be extracted and then sample will be~     processed through quantitative polymerase chain reaction (qPCR) for quantitative analysis of~     bacterial count of porphyromonas gingivalis.~   "
5173|NCT03499171|"~     Citalopram is a drug used in the treatment of depressive episodes and belongs to the group of~     selective serotonin reuptake inhibitors (SSRI). Serotonin is an important neurotransmitter~     predominantly found in the brain and the gastrointestinal tract. Serotonin is associated with~     psychological disorders, including anxiety and depression, and emotion regulation and it has~     been shown that anxiety and depression are associated with increased severity of GERD-related~     symptoms. Citalopram and other SSRI's elevate the concentration of serotonin by blocking the~     reabsorption into the presynaptic neuron and thereby increasing the level of serotonin~     available to bind the postsynaptic receptor. A recent study showed beneficial effects of~     citalopram in patients with reflux hypersensitivity. However, there was no objective~     measurement for reflux nor esophageal sensitivity during the treatment period. Moreover, the~     effect of citalopram in patients with functional heartburn has not been studied so far.~     Therefore, we will conduct a randomized, parallel, placebo-controlled study to evaluate the~     efficacy of citalopram on the improvement in symptom severity, reflux parameters and~     esophageal sensitivity. 50 patients with reflux hypersensitivity and 50 patients with~     functional heartburn will receive either placebo or citalopram (Cipramil®) 20 mg as an add-on~     for a period of 8 weeks. Symptom severity will be assessed by a validated reflux~     questionnaire (ReQuest questionnaire and diaries), reflux parameters by performing a 24 hour~     impedance-pH monitoring and esophageal sensitivity using our multimodal esophageal~     stimulation paradigm~   "
5174|NCT03499158|"~     Terminal latency index, residual latency and median ulnar F latency difference in carpal~     tunnel syndrome are specific parameters for the diagnosis~   "
5323|NCT03497195|"~     To achieve TB control, innovative case finding interventions are needed that will reach the~     broader affected population including those that do not access the health facilities.~     Systematic community case finding with highly sensitive screening and diagnostic tools are~     needed. At the facility level, the index of suspicion for TB by health care workers needs to~     be raised to ensure that all those that need TB screening are appropriately screened.~   "
5176|NCT03499132|"~     Obstructive sleep apnea (OSA) is a common form of sleep disordered breathing characterized by~     partial or complete upper airway obstructions during sleep. OSA is associated with major~     comorbidities and perioperative complications. These complications are caused not only by the~     OSA itself, but also by exacerbations of this syndrome during the perioperative period (1).~     Benzodiazepines, volatile anesthetics and opioids may lead to lower hypoxia and hypercapnia~     sensitivity and may cause respiratory depression (2-5). Therefore, preference of neuraxial~     blockades and avoidance of opioids has been suggested for patients with OSA (6). However,~     there is still lack of evidence to evaluate the effects of various anesthesia procedures on~     OSA (6,7). We hypothesize different anesthetic procedures will have different effect on OSA~     exacerbations in the postoperative period. Accordingly, the aim of this study is to compare~     the number of sleep disordered breathing episodes in the postoperative period in patients~     with different anesthetic procedures.~   "
5177|NCT03499119|"~     AMG 334 20160172 Pediatric Migraine PK Study.~   "
5178|NCT03499106|"~     The primary objective of the study is to evaluate the effect of itraconazole (a potent~     cytochrome P450 isoenzyme [CYP]3A inhibitor) on the pharmacokinetics of IW-1973.~   "
5179|NCT03499093|"~     The aims of this study were to develop a French version of the Orofacial Esthetic Scale~     (OES-F) and to investigate its psychometric properties.~      The OES is an eight-item instrument that assesses self-reported orofacial esthetics in~     prosthodontic patients. The first seven items refer to direct esthetic impacts and the eight~     is a global assessment item. For each item, an 11-point numeric scale (ranged from 0 = very~     dissatisfied to 10 = very satisfied) is used, and the first seven scores are combined into a~     summary score from 0 (worst score) to 70 (best score). The original English version of the~     OES was translated into French according to the guidelines. The reliability (internal~     consistency and test-retest reliability) and validity (convergent and discriminative~     validities) were tested in a sample of 140 patients. To assess test-retest reliability, 35~     patients answered twice the OES-F with a temporal distance of two weeks apart.~   "
5180|NCT03499080|"~     In 2015 the Norwegian government, after initiative from user organizations, decided to~     implement medication free inpatient treatment units. The goal is to secure real options to~     medication for psychiatric illness, and to gather experiences with medication free options.~     Freedom of choice is a main concern.~      The projects main aim is to study the outcome of medication free treatments of mental illness~     compared to treatment as usual, as well as characteristics of the treatment and the treatment~     population and why patients choose this treatment. Hereunder we aim to document who asks for~     these kinds of services and why, what kind of treatment they get, how they experience it, and~     how they respond to this kind of treatment. An important part will be to document whether the~     goal of increased freedom of choice between real treatment options is fulfilled.~      Research questions~        1. Does medication free treatment differ from treatment as usual? Are there any unique~          characteristics of the patient group who asks for this kind of treatment? What kind of~          treatment do they receive during their stay? How do they experience this treatment in~          comparison to treatment as usual? How is this in relation to the goals about increased~          freedom of choice? Does use of medication change during and/or after medication free~          treatment?~        2. Why do patients choose medication free treatment? What are their reasons? What~          experiences lead to this wish?~        3. What is the outcome of medication free treatment compared to treatment as usual?~   "
5181|NCT03499054|"~     Breathing exercises to improve fatigue and quality of life in hemodialysis patients~   "
5182|NCT03499041|"~     The purpose of the study is to determine whether LY3314814 can be safely prescribed in~     participants with liver impairment without a dose adjustment. Participants will be on study~     for 11 days with follow-up about 7 days afterward.~   "
5183|NCT03499028|"~     JointCOACH is a web-based communication platform that enables joint replacement patients to~     communicate with their care team via computer or smartphone throughout their episode of care,~     from the time that surgery is scheduled until at least 90 days postoperatively.~   "
5184|NCT03499015|"~     Otitis media with effusion (OME) is very common in children and characterized by fluid in the~     middle ear without signs or symptoms of acute ear infection. Treatment options are~     tympanostomy tubes and/or adenoidectomy. However OME often reoccurs after these procedures.~      Goal of this study will be to evaluate the Balloon Eustachian Tuboplasty (BET) in children as~     an additional treatment option and to assess long-term effects of BET. Beside the standard~     procedure, children (4 to 10 years of age), with equal pathology on both ears, will be~     assigned for BET on side.~   "
5185|NCT03499002|"~     The purpose of this project is to compare in situ simulation with standard lab simulation. To~     do this, 30 pre-clinical medical students will be randomized into the lab or ER and taught~     how to suture a simple laceration. To do this, a synthesized 'skin' will be placed over a~     volunteer's arm and will have an incision of a predetermined length.~   "
5186|NCT03498989|"~     Breast milk is an extremely complex and highly variable biofliud that has evolved to nourish~     infants and protect them from disease whilst their own immune system matures. The composition~     of human breast milk changes in response to many factors, matching the infants requirement~     according to its age and other characteristics.~   "
5187|NCT03498976|"~     Pulsed radiofrequency produces more lasting pain relief than use of peripheral blocks or~     analgesic medication in the treatment of chronic pain.~      We study the use of pulsed radiofrequency on the suprascapular nerve and the Circumflex nerve~     and the efficacy of the single technique on suprascapular nerve versus the circumflex and~     suprascapular combinated technique~   "
5205|NCT03498742|"~     Since 2006 there was a plateau in world wide mortality from asthma. Overreliance in Short~     Acting Beta2 Agonists (SABA) was associated with increased risk of death from asthma. Long~     acting beta agonists (LABA) alone was not permitted as treatment for asthma as it was~     determined by FDA by the black box. By contrast SABA does not have a black box, despite~     similar overuse alerts associated with increased risk of death from asthma. the investigators~     want to know if exist asthmatic subjects that do use another rescue medication; not SABA, and~     to compare their features, Asthma Control Test (ACT), and lung function in a outpatient~     facility.~      First consecutive visits at outpatient Pulmonary Section of asthmatic subjects were~     described. Asthma Control Test (ACT) that was routinely used to assess asthma and spirometry~     were performed.~   "
5188|NCT03498963|"~     Little data is currently available on the type of pathogen responsible for respiratory~     infections following drowning. Many environmental germs present in seawater are described as~     difficult to culture on standard media but are potentially pathogenic. Even using specific~     culture media nearly 90% of the bacteria present in the water remain non-cultivable. The use~     of 16S and 18S rDNA amplification followed by high throughput sequencing on respiratory~     samples could allow us to objectify these bacteria potentially involved in the~     physiopathological process secondary to drowning and thus improve their overall management.~      Carrying out a bronchoalveolar lavage (BAL) within 24 hours after admission to intensive care~     with analysis on standard and specific culture media of environmental germs, carrying out~     antibiograms, DNA extraction, amplification by universal 16 and 18S rDNA primers followed by~     high flow sequencing and phylogenetic analysis of pathogens found. Comparison of these~     results with the same analyses performed on seawater samples taken near the drowning site and~     during a new AML at 72h for patients still intubated and showing signs of pneumonia in order~     to determine if the pathogens detected at the entrance persist and are present in the~     environment.~      AML at the patient's entrance, on day 3 and environmental sampling in the drowning~     environment within 24 hours. Standard and specific bacteriological analyses with molecular~     biology techniques (amplification 16 and 18S rDNA) carried out at Pr RUIMY's laboratory (Nice~     University Hospital) sequencing on INRA's Toulouse genomics platform. Phylogenetic data~     capture and analysis at IRCAN (Bioinformatics, Croce Olivier). Patient follow-up until~     resuscitation discharge.~   "
5189|NCT03498950|"~     During conditioning with chemotherapy and radiotherapy for the transplantation of~     hematopoietic stem cells (HSCT), oral changes, such as mucositis, xerostomia infections and~     dysgeusia may occur. Low level laser therapy is used to minimize the intensity of the~     lesions, prevent ulcerations in the mucosa, and diminish the time of healing. To verify the~     efficacy of low level laser therapy in the prevention of dysgeusia in patients undergoing~     allogenic HSCT and detect the frequency of dysgeusia, the flavors most changed, and the~     association of these changes with the clinical conditions of the patient. The study sample~     will be composed of 80 patients selected at the Hematopoietic Stem Cell Transplantation~     Center of the Hospital Israelita Albert Einstein. The patients will be randomized and~     distributed into two groups: Placebo Group (n=40) - submitted to the routine laser therapy~     protocol in addition to simulated laser irradiation on the taste papillae; Test Group (n= 40)~     - submitted to the same laser therapy protocol as that of the Placebo Group, however, laser~     irradiation on the taste papillae will be effective. Daily intraoral exam will be performed~     in all the patients to evaluate mucositis, xerostomia and depapillation. The taste acuity~     test will determine the function of taste, using samples with the four basic flavors. This~     will be performed on the first day of conditioning (T0), during the stage of neutropenia~     (T1), at the time of discharge after transplantation (T2) and 100 days after transplantation~     (T3). A questionnaire will also be applied to evaluate the impact of changes in taste, smell~     and xerostomia on the quality of life. Our hypothesis is that the laser irradiation on the~     lingual papillae would help to prevent the changes in the cells of the taste papillae,~     preserving their morphology and function, which may attenuate the change in sense of taste~     and have a positive impact on the quality of life of patients during transplantation.~   "
5190|NCT03498937|"~     The study aims to evaluate the impact of transcranial direct current stimulation (tDCS) on~     impulsiveness of adults suffering from Borderline Personality Disorder. Short- and long-term~     effects are assessed by electroencephalography (EEG) records, experimental tasks and~     self-rated scales.~   "
5191|NCT03498924|"~     Endometrial cancer is the most common malignant tumor of the female genital tract in our~     means. The diagnosis is made by endometrial biopsy sampling with anatomopathological analysis~     which pinpoints the cell line and the level of cell differentiation. Its treatment is~     surgical with adjuvant treatment (chemotherapy or radiotherapy) besides, depending on the~     staging. Thus far, in the first diagnosis it is only request the tumor marker CA125 in serum,~     but there are studies that identify the HE4 protein in blood as a feasible marker for~     endometrial cancer. Furthermore, the staging changes the surgical and the adjuvant treatment:~     in its early stages, surgery is based on hysterectomy and double adnexectomy, however, in~     later stages it is necessary to add pelvic and paraaortic lymphadenectomy with the associated~     comorbidity. This makes extremely important that the preoperative diagnosis is accurate. The~     aim of this study is to identify and characterize the HE4, Ki67, p53 and other potential~     biomarkers in endometrial tissue in order to diagnose patients with disease only with a~     biopsy. Moreover, the investigators are searching for connections among these markers and~     prognostic factors such as grade of cell differentiation, cell line, lymphatic affectation,~     tumor stage or even features as survival or disease free survival.~   "
5192|NCT03498911|"~     The purpose of this study is to assess the influence of two different flap designs (envelope~     Coronally Advanced Flap (eCAF) and Modified Tunnel Technique (MTT)) with the addition of a~     connective tissue graft (CTG) in treating soft tissue dehiscences at implant sites~   "
5193|NCT03498898|"~     This study is designed to discover if chronic use of Beta adrenergic receptor blockers~     affects pain sensation during and after an elective procedure of hip replacement. The study's~     population will be divided to two groups: Group A- chronic use of Beta adrenergic receptor~     blockers and Group B- no use of Beta adrenergic receptor blockers. Each patient will be~     anesthetized using the same anesthesia protocol with pain assessment done by the ANI device~     intra operatively and by NRS score postoperatively.~   "
5194|NCT03498885|"~     The purpose of this study is to explore the different impacts of high and low ligation in~     laparoscopic rectal interior resection on postoperative anastomotic leakage and proximal~     bowel necrosis and stenosis, as well as the quality of life and long-term survival. In the~     anterior resection of rectum, the section level of inferior mesenteric artery (IMA) is still~     a controversial subject between the advocates of high and low ligation. The low ligation is~     defined as the IMA is ligated below the origin of the left colic artery while the high~     ligation refers to the IMA is ligated at its origin from the aorta. Nowadays the spread of~     laparoscopy has encouraged more frequent execution of the high ligation, which appears easier~     to achieve than the low ligation and also with the advantage of lower anastomosis traction~     but with the disadvantage of worse vascularization of the stumps as well.~   "
5206|NCT03498729|"~     This research study is being done to find out whether autoimmune mechanisms are associated~     with the development of atrial fibrillation.~   "
5207|NCT03498716|"~     This study will evaluate the efficacy, safety, and pharmacokinetics of adjuvant atezolizumab~     in combination with paclitaxel, followed by atezolizumab, dose-dense doxorubicin or~     epirubicin (investigator's choice), and cyclophosphamide, compared with paclitaxel followed~     by dose-dense doxorubicin or epirubicin (investigator's choice) and cyclophosphamide alone in~     patients with Stage II-III TNBC (Triple Negative Breast Cancer)~   "
5208|NCT03498703|"~     Azathioprine increase pregnancy rate in patients with recurrent implantation failure~   "
26511|NCT03219970|"~     To assess the efficacy of single-agent osimertinib in relation to EGFR T790M mutant allele~     fraction (AF) in a real-world setting.~   "
5195|NCT03498872|"~     Objectives: The main objectives are to determine neural dynamics during gait using~     electro-encephalography as well as brain sources and to investigate the attentional demand~     during walking in able-bodied individuals, and individuals with an amputation.~      Materials & Methods: 6 able-bodied individuals conducted one experimental trial, and 6~     unilateral transtibial and 6 unilateral transfemoral amputees performed 2 experimental~     trials; the first with the current and the second with a novel powered transtibial~     prosthesis, i.e. the Ankle Mimicking Prosthetic foot 4.0. Each experimental trial comprised 2~     walking tasks; 6 and 2min treadmill walking at normal speed interspersed by 5min of rest.~     During 6min walking the sustained attention to response (go-no go) task, with measures~     reaction time and accuracy, was performed. Electro-encephalographic (EEG) data were gathered~     when subjects walked 2min. Motor-related cortical potentials and brain activity during gait~     are extracted using EEG.~   "
5196|NCT03498859|"~     This study investigates the efficacy of physiotherapist-supervised training once per week~     during 10 weeks compared to home-based training during 10 weeks, after proksimal humerus~     fracture.~   "
5197|NCT03498846|"~     Modified corneal epithelial autograft (EA) uses a smaller graft of the donor eye, which~     decreases iatrogenic injury greatly. The purpose of this study is to explore whether modified~     corneal EA combined with allogeneic middle lamellar keratoplasty (AMLK) is more effective~     than limbal autograft (LA) with AMLK for ocular surface reconstruction in patients with~     severe corneal burn.~   "
5198|NCT03498833|"~     Background:~      Symptoms, balance, mobility, activities of daily life (ADL) and quality of life (QoL) are to~     be considered in rehabilitation of the individuals with knee osteoarthritis (IKOA). There are~     several scales to evaluate subjective perceptions and individual components in patients with~     osteoarthritis (OA). Till date, no scale is available to measure the combined balance,~     mobility, ADL and QoL in PKOA.~      Objectives:~      The objectives of the study are to develop a combined measure of symptoms, balance, mobility,~     ADL and QoL in PKOA, as comprehensive knee osteoarthritis index (CKOAI) and to validate the~     scale for its content, reliability and minimum detectable change (MDC)~      Methods:~      The study consists of a four stages. First stage is the scale (CKOI) item development and~     validation. This includes domain and item generating through systematic literature search to~     extract items related symptoms, balance, mobility, ADL and QoL in IKOA based on the~     International Classification of Functioning, Disability and Health (ICF) and through~     structured interviews. Then an expert panel will review the generated domains and items,~     which will undergo revision and pilot testing. Based on the responsiveness of pilot testing~     will be revised finally. Second stage is to test re-test reliability and inter rater~     reliability. The third stage is to establish content and criterion-related validity. The~     final stage will be reporting the minimal detectable change (MDC).~      Data analysis:~      All the domains and items in CKOAI will undergo reliability and criterion-related validity.~     Minimum 60 IKOA will be evaluated with the scale on two occasions within two weeks to~     establish test retest reliability. Cronbach's alpha for internal consistency and Intra class~     correlation coefficient for test retest reliability will be used to determine the degree of~     consistency of items in the scale. MDC will be calculated using the formulae, SEM = SD x √~     (1-reliability) and MDC95 = √2 x (1.9) x (SEM). Significant level will be set at p value less~     than 0.05 (p < 0.05) to minimize the type-I error.~   "
5199|NCT03498820|"~     This study compares two groups of patients undergoing a gynecological surgey under general~     anesthesia: one group in which intraoperative analgesia is guided by the~     Analgesia-nociception index, and another group in which intraoperative analgesia is managed~     as in standard practice. The objective is to assess if the Analgesia Nociception Index may~     result in a decrease in total analgesic drugs consumption, a decrease in post-operative pain~     and in chronic pain development.~   "
5200|NCT03498807|"~     The study of positive end-expiratory pressure(PEEP) in the setting mode has not yet been~     conclusive. there are several ways to choose the best positive end-expiratory pressure(PEEP)~     mode for ARDS patients. In this study ,the investigators selected two best positive~     end-expiratory pressure(PEEP) assessment methods to compare:~      First is using the conventional postive ventilator to choose positive end-expiratory~     pressure(PEEP) and the new non-invasive electrical impedance tomography(EIT) guided method~     and evaluation the treatment outcome in moderate and severe acute respiratory distress~     syndrome patients by using pressure-volume curve guided and electrical impedance tomography~     guided positive end-expiratory pressure setting. In this project, we utilize a newly~     available non-invasive method- electric impedance tomography (EIT) and Protective Ventilation~     to determine the optimal PEEP on ARDS patients required invasive mechanical ventilator~     support at a medical center medical ICU (MICU) and cardiovascular ICU (CVICU)- the Far~     Eastern memorial hospital, Taiwan.~   "
5201|NCT03498794|"~     Non-malignant causes of ureter obstruction can be intrinsic such as stone disease, ureter~     stricture or congenital ureteropelvic junction obstruction, or extrinsic such as idiopathic~     retro peritoneal fibrosis. Nearly all clinicians agree that obstructing stones, with a~     concern for sepsis require immediate decompression of the urinary system.~      Though large epidemiologic studies of the management of obstructed infected nephrolithiasis~     demonstrate higher rates of sepsis and mortality associated with PCN placement relative to~     ureteral stenting, the observational nature of the analysis highlights the need for~     prospective analyses of PCN vs stenting for obstructive nephrolithiasis.~      Despite this obvious need, there are few studies comparing the efficacy of ureteral stenting~     vs PCN in the setting of obstructive urolithiasis. The choice between PCN and stenting is~     often made by the urologist at initial presentation and can be influenced by factors~     including disease severity, stone size, location of stone, eventual modality of definitive~     stone management, or even availability of in-house interventional radiology services.~      Retrospective studies reveal that both procedures have high success rates. In the setting of~     unsuccessful stenting, PCN is often successful, but the contrary is not always true.~     Furthermore, patients are often selected for PCN over ureteral stenting in the setting of~     larger stones and if they are more severely ill.~      Goldsmith et al studied 130 patients who underwent decompression for obstructing ureteral~     stone with PCN or stent placement. Although patients who underwent PCN placement had longer~     hospital stay, other outcomes such as time to definitive stone management, rates of~     spontaneous stone passage, and initiation of stone metabolic workup were not statistically~     different. The authors noted that the method of initial decompression correlated with~     eventual approach selected for definitive stone management. Patients treated with PCN were~     more likely to undergo percutaneous definitive management, while patients managed with~     ureteral stenting were more likely to be treatked with a ureteroscopic approach.~      Two prospective studies comparing PCN vs stent management of obstructing ureteral stones have~     conflicting outcomes. Mokhmalji et al 6 in 2001 prospectively randomized 40 patients to~     receive either PCN or stent. Sixteen out of twenty stents were successfully placed while all~     twenty PCNs were successfully placed initially. All unsuccessful stents were successfully~     managed by PCN. Their results demonstrated that stent utilization was less successful as~     compared to PCN and there was a trend for longer antibiotic therapy due to persistent signs~     of urinary tract infection in patients who underwent stent placement.~      In contrast, Pearle et al randomized 42 patients to receive PCN vs stents. This study failed~     to demonstrate one procedure to be more successful than the other. All 21stents and 20 out of~     21 PCNs were successfully placed. One failed PCN successfully underwent stent placement.~     Their results demonstrated an increased incidence of bacterial urinary colonization~     post-procedure in the PCN group as compared to the stent group, but overall no differences in~     time to clinical improvement or length of stay were noted.~   "
5202|NCT03498781|"~     The purpose of this study is to explore the effects of an intervention designed to help~     increase physical activity and decrease screen time.~   "
5203|NCT03498768|"~     Lung cancer is one of the leading cause of cancer related death in China.Different from~     patients in the US, Chinese patients with lung nodules tend to be less related to smoking,~     and seem to be more willing to get operation despite of the doctors' suggestion of imaging~     surveillance.~      This study is designed to figure out the risk factors for Chinese lung cancer patients and~     evaluate the psychosocial status of inpatients with lung nodules.~   "
5294|NCT03497572|"~     The study aims to assess antibody persistence induced by Spirolept® vaccination in subjects~     who received at least 4 doses (2 doses two weeks apart and 2 booster doses) and no more than~     a total of 8 doses (2 doses two weeks apart and 6 booster doses).~   "
5209|NCT03498690|"~     The Protocol Lab for Online Trials-Delphi (PLOT-D) module will use an online three-round~     Delphi combined with Participatory action research to inform the development of a multi-use~     protocol template to use in writing protocols for self-recruited online trials of~     interventional self-management. The Delphi will include an embedded randomized controlled~     trial to test how and if stakeholders adapt their views based on the contributions of others~     inside or outside the groups with which they are familiar.~   "
5210|NCT03498677|"~     This study nested as a randomized controlled trial within an online Delphi and will assess~     the impact of using different question section groupings to provide aggregate feedback to~     participants in an online Delphi study.~   "
5211|NCT03498664|"~     Lateral Spreading Tumors (LSTs) are dysplastic lesions whose protrusion within the lumens~     the colon is not more than twice as compared to the surrounding non-dysplastic mucosa.~      They can be divided into two groups:~      Granular type (LST-G) and Non Granular type (LST-NG) Endoscopic mucosal resection (EMR) and~     endoscopic submucosal dissection (ESD) are currently the most used techniques to resect this~     type of lesions. Compared to other methods of tissue ablation, EMR allows to carry out the~     histological evaluation of the resected fragments and ESD of the lesion in toto (en bloc)~     EMR is currently the most used technique for removal of LST, but for lesions of ≥ 30 mm the~     resection is performed piecemeal, i.e. fragmentary. This can compromise an adequate~     histological evaluation of the lateral and deep margins of the lesion.~      Colonic EMR (EMR-S) is usually performed using a polypectomy snare, after lifting the lesion~     from the underlying layers with a submucosal injection of liquid (EMR standard or~     inject-and-cut). The aspiration of the lesion inside a plastic cap preloaded on the tip of~     the colonoscope (cap-assisted EMR - EMR-C) is almost exclusively used for the treatment of~     gastric and esophageal lesions. Its use for lesions of the colon and duodenum has been~     reported in limited experiences The principal aim of this study is to evaluate the efficacy~     and the safety of the EMR-C for the removal of large colonic LST-G and LST-NG, comparing it~     with EMR-S.~   "
5212|NCT03498651|"~     The project aims to compare effectiveness and target engagement of CBM-I delivered via~     computer vs. mobile phone, and test if adding minimal human contact for participants at risk~     of dropout improves retention and outcomes.~   "
5213|NCT03498638|"~     The purpose of this study is to understand whether the couple therapy that is used in~     practice is effective in preventing situational couple violence. More specifically,~     investigators will focus on couples with mild to moderate forms of situational couple~     violence to investigate how couples therapy can be effective in preventing the escalation and~     recurrence of situational couple violence. For this purpose, the response of partners to~     therapy will be investigated by integrating self-report questionnaires and~     psycho-physiological markers of emotion.~   "
5214|NCT03498625|"~     The CDEIS (Crohn's disease endoscopic index of severity) and its derivative, SES-CD (single~     endoscopic score for Crohn's disease) were constructed to evaluate the endoscopic severity of~     Crohn's disease (CD). The current therapeutic goal in CD is endoscopic remission, which is~     thought to be predictive of a favourable evolution of the disease. However, up to now there~     is no measure of endoscopic remission, objectively constructed and validated, not even a~     consensus for its definition. An objective measure of endoscopic remission is necessary,~     notably for the evaluation of new treatments, a request of the regulatory agencies (FDA and~     EMA), but also in clinical practice if one wishes to adapt the treatment of patient according~     to the level of endoscopic remission.~      The aim of the study is to construct a measure of endoscopic remission based on an objective~     assessment (depth or grade) of remission, that must be reproducible, little or not dependent~     on the reader interpreting the endoscopy.~      The CREDO 1 program is a cross-sectional study designed to construct objectively a measure of~     the endoscopic remission of CD through an index measuring its depth or a score measuring its~     grade and to evaluate its reproducibility.~      This study is composed of four main parts:~        1. Training and selection of readers:~             -  Selection and definition of all lesions to be studied at consensus meetings, first~               between the central readers, then with the participation of local investigators.~             -  Specific training of local investigators in the recognition of endoscopic lesions~             -  Checking the performance of the central readers~        2. Recruitment of patients by investigators - local readers:~             -  Inclusion criteria: CD diagnosed for more than 6 months, in clinical remission for~               at least 3 months, with a Crohn's disease activity index < 150 at the time of~               endoscopy.~             -  Each local investigator will have to record 15 videos divided according to his/her~               overall judgment into 3 status of remission: Complete Remission; Remission almost~               complete; Remission neither complete nor nearly complete.~             -  The colon will be divided into 7 segments: ileum, ileocecal valve, right colon,~               transverse colon, descending colon, sigmoid colon and rectum. Each segment will be~               identified by landmarks.~             -  Videos will be anonymized and then centralized at a healthcare provider (OVH -~               SAS).~             -  16 French and Belgian centers will participate in the study leading to a total of~               240 films.~        3. Analysis of videos by central readers:~             -  12 central readers will independently read 80 out of the 240 videos~             -  Videos allocation to central readers will be performed through balanced incomplete~               block method to ensure that each central reader, as well as each central reader~               pair, has the same weight in achieving the results.~             -  A quantitative evaluation of the depth of endoscopic remission on a visual analogue~               scale and a qualitative evaluation of the grade of remission on a 5-level ordinal~               scale will be provided by each central reader, segment by segment and globally, in~               addition to the description of all lesions identified by segment.~        4. Analysis of the data recorded by the central readers:~             -  An index (depth of remission) or score (grade of remission) will be constructed~               from linear or multiple logistic regression models, considering the reader and~               endoscopy as random factors, to take into account the dependence between the~               readings performed on different endoscopies by the same central reader or on the~               same endoscopy by different readers.~             -  Variations in readings between central readers will be quantified through the Kappa~               coefficient for qualitative items and through the intraclass correlation~               coefficient for quantitative items.~      In an observational longitudinal multi-center cohort study (CREDO 2), it will be tested~     whether the index or score thus constructed is able to predict prolonged clinical remission~     for 2 years in patients in clinical remission at baseline. If this test is successful, we~     will have a primary objective and reproducible criterion for evaluating treatments in CD and~     a useful tool for the management of these patients in clinical practice.~   "
5215|NCT03498612|"~     This phase II trial studies how well pembrolizumab works in treating participants with B-cell~     non-Hodgkin lymphoproliferative diseases that have not been treated. Monoclonal antibodies,~     such as pembrolizumab, may interfere with the ability of cancer cells to grow and spread.~   "
5216|NCT03498599|"~     The purpose of this study is to use functional magnetic resonance imaging to investigate how~     the human brain learns to form associations between neutral and emotional stimuli. The study~     is based on the basic principles of Pavlovian conditioning.~      When someone learns that a neutral stimulus (such as the sound of a bell) predicts an~     unpleasant stimulus (such as a mild electrical shock), the neutral stimulus takes on the~     properties of an emotional stimulus.~      The investigators are interested in the neural processes involved in this learning in people~     with a clinical anxiety disorder and posttraumatic stress disorder (PTSD).~   "
5217|NCT03498586|"~     The study evaluates the use of half-normal saline as an irrigant for open-irrigated catheters~     during atrial fibrillation ablation. By increasing the efficacy of radiofrequency~     energy-mediated lesion formation, half-normal saline has the potential to reduce procedural~     times and improved acute and long-term outcomes.~   "
5218|NCT03498573|"~     patients suffering from anterior maxillary horizontal bone defect the alveolar ridge will be~     augmented by minimally invasive tunneling technique utilizing MPM as bone graft and patients~     followed up for 14 weeks .~   "
5219|NCT03498560|"~     The investigators are performing this research study to understand the role of sleep~     disturbance on the incidence/severity of delirium after surgery. The investigators will study~     the brain using a polysomnography device (PSG), which records the brain's electrical activity~     during sleep.~   "
5220|NCT03498547|"~     Anorectal surgery includes pilonidal sinus, hemorrhoidectomy, anal fissure, and anal fistula~     operations. Various surgical and anesthetic techniques have been used to increase the level~     of analgesia in perioperative period and decrease the length of stay in the hospital. In this~     study, investigators investigate the effects of routinely applied anesthesia techniques~     during anorectal surgery, caudal block and saddle block, on patients' perioperative~     hemodynamic values, sensory and motor block levels, and postoperative pain scores.~   "
5221|NCT03498534|"~     Clinical test (essay) randomized to evaluate the toxicity adherence and efficiency of the~     chemoprophylaxis of tuberculosis (TB) in subjects with Diabetes Mellitus (DM) and latent TB.~     (600 subjects followed(continued) by 15 months). 3rd stage. Patients with DM and TB will be~     included to determine if the strict control of the dm achieved in clinics of the first level~     of attention improves clinical manifestations of tb, the result of treatment, the frequency~     of relapses, the mortality and the transmission to contacts.~      Elispot will be used to measure TB development and the time for the bacteriological~     negativization and biochemical parameters as well as tuberculin skin test (TST), quantiferon,~     in contacts. (160 patients 600 contacts followed(continued) for 12 months). additional there~     will be evaluated the socioeconomic impact of both diseases and his(her) control. 1er year:~     transverse study and recruitment years 2 and 3 participants' follow-ups in clinical~     tests(essays).~   "
5222|NCT03498521|"~     This study will compare the efficacy and safety of molecularly-guided therapy versus standard~     platinum-containing chemotherapy in participants with cancer of unknown primary site (CUP;~     non-specific subset) who have achieved disease control after 3 cycles of first-line platinum~     doublet induction chemotherapy.~   "
5324|NCT03497182|"~     Breath samples will be collected from patients suspected of sepsis/severe sepsis or septic~     shock according to hospital sepsis screening criteria in the Emergency Department.~   "
5223|NCT03498508|"~     Theoretical knowledge of cardiopulmonary resuscitation (CPR) is the foundation of being able~     to perform CPR in a cardiac arrest situation. The knowledge and skills received in training~     is easily lost and after one year the level is equal to pretraining. International studies~     regarding knowledge of CPR among healthcare professionals, mostly nurses, show poor results.~     The knowledge of CPR among Swedish healthcare professionals is poorly studied.~      The aim of this study was to describe the knowledge of CPR and self-perceived skills of~     performing CPR among healthcare professionals working in four hospitals in Sweden.~   "
5224|NCT03498495|"~     SMART is an interactive web-based program that will allow youth with mild traumatic brain~     injuries (mTBI) to monitor their symptoms and receive education on problem-solving and coping~     strategies. This study will evaluate the effectiveness of SMART as a means of improving~     symptom-management, coping skills, and general well-being during recovery from mTBI. Half of~     participants will receive the SMART intervention, while half will receive usual care.~   "
5225|NCT03498482|"~     Children either living in the streets of Bujumbara or that are similarly affected by extreme~     poverty or violence are regularly exposed to traumatic events. Additionally, they often find~     themselves in situations where engaging in violent behavior appears to be useful or even~     necessary for survival. The Narrative Exposure Therapy for violent offenders (FORNET) aims to~     reduce both PTSD symptoms and aggressive behavior. It helps the children to anchor fearful~     experiences and potential positive emotions linked to violent behaviour in the past.~     Additionally, visions for the future are developed in order to enable reintegration into the~     family.~      The investigators want to provide evidence, that FORNET effectively reduces PTSD symptoms and~     ongoing aggressive behavior which in change facilitates reintegration into society.~   "
5226|NCT03498469|"~     The proposed study will be an individually randomized controlled trial with children (age 1~     to 13 years at the time of screening for inclusion in the study) living in residential care,~     reintegrated back into family-based care, in Uganda. It is designed to evaluate the impact of~     adding a household-based parenting program to a standardized reintegration package that~     includes individualized case management support and a reunification cash grant, aimed at~     improving the reintegration of children living in residential care back into family-based~     care. The study population will include children living in residential care facilities (RCFs)~     in Mpigi, Mukono, Masaka and Greater Masaka districts in Uganda.~      Study participants will be randomized to one of two arms of the study: the comparison arm and~     the intervention arm. The target sample size is 640 children with 320 in each arm of the~     study. Children assigned to the comparison arm will receive a standard reintegration package~     that includes individualized case management support and a reunification cash grant. Those in~     the intervention arm will receive the enhanced reintegration package that includes~     individualized case management support, reunification cash grant and a parenting~     intervention. Data will be collected at baseline (while the child is still living in the~     RCF), 6 months post-placement and 12 months post-placement.~      Data will be collected in the local language by a project trained local data collection~     partner on the following six domains of reintegration: Child health and development,~     Psychosocial health and wellbeing of the child and primary caregiver, Protection and safety~     of the child, Caregiver-child relationship, Child's and caregiver's sense of social and~     community belonging, Education access, quality, and achievement (where age-appropriate).~      The sources of data are a) interviews with primary caregiver, b) interviews with RCF~     caregiver, c) interviews with older children (8-13 years of age), d) standardized assessments~     of child cognitive functioning for all the study children, and e) focus groups and interviews~     with participants, parenting facilitators, and case managers.~   "
5227|NCT03498456|"~     The current study is designed to demonstrate the non-inferiority of tegoprazan triple therapy~     (tegoprazan, amoxicillin, and clarithromycin; hereinafter TAC) to lansoprazole triple therapy~     (lansoprazole, amoxicillin, and clarithromycin; hereinafter LAC) in terms of H. pylori~     eradication rate and to evaluate the safety of tegoprazan after oral administration of the~     therapy for 7 days, twice daily in H. pylori positive patients.~   "
5228|NCT03498443|"~     study on female sexual function after different prolapse surgeries~   "
5229|NCT03498430|"~     This study will be conducted primarily to determine the pharmacokinetics of copanlisib in~     Chinese patients with relapsed iNHL.~      The primary objective of the study is to determine the pharmacokinetics of copanlisib~     administered on Day1, 8, and 15 of a 28-days cycle (3 weeks-on/1 week off dosing regimen) as~     a 1 hour intravenous infusion to Chinese patients with relapsed iNHL.~      The secondary objectives include the evaluation of safety, tolerability, and tumor response~     of Chinese patients treated with Copanlisib.~      Determine the pharmacokinetics of M-1 metabolite.~   "
5230|NCT03498417|"~     The study is aimed at assessing IGF-1R-Abs in patients with Graves' disease, with or without~     GO, compared with healthy subjects and patients with autoimmune thyroiditis in a~     cross-sectional investigation.~   "
5231|NCT03498404|"~     Chronic periodontitis is an infectious disease resulting in inflammation of the teeth support~     structures, progressive periodontal attachment loss and bone loss. The aim of this study is~     to evaluate the effects of antimicrobial photodynamic therapy (TFDA) in multiple applications~     as an adjunct to surgical periodontal therapy in patients with generalized severe chronic~     periodontitis. A total of twenty patients will be submitted to this split-mouth trial,~     receiving initial periodontal basic nonsurgical treatment that is scaling and root planing.~     After the sites are indicated for surgical therapy, they receive surgical access therapy~     associated with scaling and root planing and TfdA using the treatment protocol during periods~     of 0, 7, 14 and 30 postoperative days, or only surgical access therapy associated with~     scaling and root planing. As protocol, TfdA will be used laser light source 660nm wavelength~     in combination with phenothiazine, a photosensitizer with 10 seconds of exposure per site~     during surgery and 60 seconds in other applications. All patients will be oral hygiene care~     and follow-up for 90 days. In the baseline period, basic post-therapy, 30 and 90 days after~     surgical therapy will be performed the clinical evaluation of plaque index, depth of probing~     pocket, level of clinical insertion relative and bleeding on probing, beyond the collection~     plate samples subgingival 40 for counting microbial species using the method of DNA-DNA~     hybridization checkerboard. For the same periods are also collected samples of gingival~     crevicular fluid for evaluating fluid volume (Periotron) and the levels of Interleukin 1~     beta, Interleukin 10, MMP-8, tumor necrosis factor alpha, RANK-L and Osteoprotegerin (OPG).~     The data are statistically analyzed with the tests to the sample.~   "
5232|NCT03498391|"~     The primary aim of this study is to determine whether spatiotemporal characteristics of~     multisensory evoked potentials can be used as a marker of consciousness (awareness) under~     anesthesia.~      The secondary aim is to characterize changes in the characteristics of evoked potentials~     under anesthesia in both single sensory modality (visual, auditory) and across sensory~     modalities.~   "
5325|NCT03497169|"~     Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the~     pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the~     pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery.~     Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological~     availability of medication. In this study the pharmacokinetic effects of bariatric surgery on~     lisdexamphetamine are investigated.~   "
5233|NCT03498378|"~     The purpose of the study is to find out if the study drugs Avelumab, Cetuximab, and~     Palbociclib will slow or stop your cancer from getting worse, and whether it causes side~     effects. The second purpose is to measure whether your cancer responds to the study drugs~     Avelumab, Cetuximab, and Palbociclib. The study drugs Avelumab, Cetuximab, and Palbociclib~     are types of drugs called a monoclonal antibody. Monoclonal antibodies are made to recognize,~     target, and bind to specific proteins on cells the building blocks making up your tissues.~   "
5234|NCT03498365|"~     To examine the effects of using decision support tools during the online Delphi process.~   "
5235|NCT03498352|"~     Cardiopulmonary exercise testing is recommended for preoperative evaluation and risk~     stratification of lung resection candidates. Ventilatory efficiency (VE/VCO2 slope) has been~     shown to predict morbidity and mortality in lung resection candidates and has been shown~     superior to peak oxygen consumption (VO2). Patients with increased VE/VCO2 during exercise~     also exhibit increased VE/VCO2 ratio and decreased end-tidal CO2 at rest. Our first~     hypothesis is that rest ventilatory parameters predict morbidity and mortality in patients~     undergoing thoracic surgery. VE/VCO2 is well correlated with ventilation-perfusion mismatch,~     therefore it may be useful in hypoxemia prediction during one-lung ventilation during~     thoracic surgery. Our second hypothesis is that patients with high VE/VCO2 will be prone to~     hypoxemia development during one-lung ventilation.~   "
5236|NCT03498339|"~     The Effect of Cesarean Operative Technique on the Occurrence of Large Hysterotomy Scar~     Defects.~   "
5237|NCT03498326|"~     The prognosis of pancreatic cancer is extremely poor, even in those patients who had~     underwent surgery, the 5-year survival is still less than 10%. Current guidelines recommend~     Gemcitabine monotherapy for R0 resection of pancreatic cancer. Inflammation plays an critical~     role in the development and progression of pancreatic cancer. Here we intend to assess the~     synergistic effect of using celecoxib in combination with gemcitabine on the treatment of R0~     resection of pancreatic cancer.~   "
5238|NCT03498313|"~     This within-person, crossover, 3-condition, placebo-controlled study compares the impact of~     three perimenstrual conditions on severity of suicidal symptoms in females with past-month~     suicidality but minimal risk of imminent suicide attempt. The three conditions are (1)~     perimenstrual withdrawal from estradiol only (during progesterone stabilization), (2)~     perimenstrual withdrawal from progesterone only (during estradiol stabilization), and (3)~     perimenstrual withdrawal from both estradiol and progesterone during placebo.~   "
5239|NCT03498300|"~     This study evaluates the seroprevalence of Bordetella pertussis antibodies and anti-pertussis~     antibodies response after its single dose of reduced-antigen, combined diphtheria, tetanus,~     and acellular pertussis vaccine (Tdap) in Thai pregnant women.~      All participants with no immunity against pertussis will receive Tdap vaccine, while immune~     participants will be equally randomized into 2 groups. Half of immune participants will~     receive Tdap vaccine and the other half will receive dT vaccine as standard protocol.~   "
5240|NCT03498287|"~     Sham-controlled, multi-center and remote patient-centered randomized controlled clinical~     trial to investigate the efficacy of a novel non-invasive, unobtrusive study device in~     reducing symptoms of carpal tunnel syndrome (CTS). Mild to severe CTS-diagnosed patients will~     wear the device daily and evaluation will be based on the Boston Carpal Tunnel Questionnaire.~     Subjects are randomized into a treatment group or sham group for 8 weeks, then followed for~     12 weeks post treatment.~   "
5241|NCT03498274|"~     This study is designed to investigate the benefits of the hearing aid in the laboratory and~     in daily life when fitted with two different methods. Subjective and objective evaluations~     will be made. The aim is to show the benefits of the hearing aids with both fitting methods~     with the help of data obtained, and to improve the available fitting methods in order to~     further increase the benefit for people with hearing disorders in situations where the~     standard method and those trained to perform it are not available.~   "
5242|NCT03498261|"~     Adding a single preoperative dose of gabapentin to the standard pain regimen will reduce~     postoperative opioid consumption within the first 72 hours in patients undergoing~     rhinoplasty.~   "
5243|NCT03498248|"~     The purpose of this study was to analyze the clinical factors associated with the effect of~     Granulocyte-Colony Stimulating Factor (G-CSF).~   "
5244|NCT03498235|"~     Intracranial pressure（ICP) increases during laparoscopic gynecologic surgery increase (ICP)~     and may alter optic nerve sheath diameter(ONSD).This study measures ONSD in different team~     because sevoflurane and propofol have different effects on ICP.Half of participants will~     receive sevoflurane anesthesia,while the other half undergo propofol anesthesia.~   "
5245|NCT03498222|"~     iTRAP is an open-label, multi-centre, dose escalation study of ADI PEG20 in combination with~     atezolizumab, pemetrexed and carboplatin in patients with advanced non-squamous non-small~     cell lung carcinoma (NSCLC) - stage IIIB/IV.~   "
5246|NCT03498209|"~     To determine the Prevalence of MIH in a group of Egyptian children attending the Pediatric~     Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University.~   "
5247|NCT03498196|"~     This is a pilot study of avelumab in patients with non-metastatic, muscle invasive bladder~     cancer who are eligible for radical cystectomy (RC), but refuse or are ineligible for~     cisplatin based neoadjuvant therapy. The target recruitment is 10 evaluable patients for this~     window of opportunity study. Pre- and post-treatment tumor samples from transurethral~     resection of the bladder tumor and RC will be used for study endpoints.~   "
5248|NCT03498183|"~     The main objective of the study is to show that the addition of ultrasonography to the dual~     tracer scintigraphy MIBI-Tc99m/Iodine-123 will increase (at least +5%) the negative~     predictive value compared to the dual tracer scintigraphy alone in detection of malignancy in~     thyroid nodules ≥15 mm classified as Bethesda III-IV on cytology.~   "
5249|NCT03498170|"~     An Open-label, 2-period, Single-sequence, Crossover Study to Evaluate the Effect of Multiple~     Oral Dosing of Itraconazole on BCT197 Systemic Exposure in Healthy Male Participants.~   "
5326|NCT03497156|"~     Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the~     pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the~     pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery.~     Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological~     availability of medication. In this study the pharmacokinetic effects of bariatric surgery on~     lercanidipine are investigated.~   "
5250|NCT03498157|"~     The purpose of this study is to determine whether patients are able to participate in a so~     called prehabilitation program (prior to the beginning of cancer treatment) which includes~     (1) a supervised and home-based exercise program plus one educational session or (2) just~     home-based exercise plus one educational session or (3) just one educational session.~      Breast cancer surgery may have potential for several side effects, including functional (e.g.~     flexibility in the affected arm, lymphedema [swelling that generally occurs in the arms or~     legs that occurs as a result of the removal of or damage to lymph nodes as a part of cancer~     treatment], shoulder pain) and psychosocial (e.g. reduced quality of life, increased fatigue)~     aspects.~      Evidence shows that exercise is considered to be an effective treatment approach in breast~     cancer patients during and after treatment with regard to the above mentioned side-effects.~     Also, prehabilitative exercise in colon and lung cancer patients was shown as feasible and~     effective. However, no experience exits with regard to prehabilitation exercise in breast~     cancer patients.~   "
5251|NCT03498144|"~     Purpose of the study~      To evaluate the lower puntum dimensions in cases of acquired punctal stenosis(APS), using~     anterior segment optical coherence tomography (AS-OCT).~   "
5252|NCT03498131|"~     To date, there are no published data on the role of melatonin supplementation or the~     appropriate dose for patients with multiple sclerosis. Because of the potential benefits of~     melatonin, this pilot study will be an exploratory investigation to evaluate the effect of~     supplementing melatonin in subjects with multiple sclerosis who are taking an oral disease~     modifying therapy (DMT) for 6 months or longer. It is our intent that the results of this~     study will support the rationale and be a prelude to a larger trial which can focus on~     clinical efficacy of melatonin therapy outcomes.~   "
5253|NCT03498118|"~     Adequate pain control after cesarean delivery is a major concern both for parturient and for~     obstetric anesthesiologists, and it usually comprises a combination of systemic and regional~     techniques.The transversus abdominis plane (TAP) block, affecting the nerves supplying the~     anterior abdominal wall, is a recently introduced, promising regional analgesic technique for~     a variety of abdominal and pelvic surgeries including cesarean delivery.(2,3) Infiltration of~     local anesthetic into the surgical wound (either as a single shot or using indwelling~     catheters) has long been used for postoperative analgesia.~      Both the TAP block (4-6) and wound infiltration is superior to placebo; however, it is~     unknown which of them provides better analgesia after cesarean delivery because of a scarcity~     of randomized clinical trials. Only 2 studies compared the TAP block with wound infiltration~     after cesarean delivery with conflicting results, and another study compared it with~     continuous wound infusion and was prematurely terminated.~      This study aimed to compare bilateral TAP block with single-shot local anesthetic wound~     infiltration for analgesia after cesarean delivery performed under spinal anesthesia. We~     hypothesized that the TAP block would decrease postoperative cumulative opioid consumption at~     24 hours~   "
5254|NCT03498105|"~     This project is aiming to identify the diagnostic utility CEB (Cardiac Electrical Biomarker)~     in patients who are undergoing cardiac investigations.~   "
5255|NCT03498092|"~     The serratus plane block (SPB) described by Blanco et al, 2013 is a progression from the work~     with the Pecs I and II blocks. The serratus muscle is a superficial and easily identified~     muscle and considered a true landmark to perform thoracic wall blocks because lateral~     cutaneous branches of the intercostal nerves pierce it in the mid-axillary line. A local~     anesthetic (LA) is injected under ultrasound (US) guidance either superficial or deep to~     serratus anterior muscle providing predictable and relatively long-lasting regional~     anesthesia, which would be suitable for surgical procedures performed on the chest wall.~      The linear US probe of frequency (6-13 MHz) is placed over the mid-clavicular region in a~     sagittal plane.The ribs are counted inferiorly and laterally until the fifth rib in the~     midaxillary line is identified.The latissimus dorsi, teres major, and serratus muscles are~     identified.~   "
5256|NCT03498079|"~     -  Mullerian anomalies are congenital structural anomalies in the uterus .~        -  Its prevalence is not uncommon .~   "
5257|NCT03498066|"~     ABYSS is a national, multicenter, randomised, open label trial using the PROBE study design,~     that will evaluate the non-inferiority of the interruption of ΒB therapy after an~     uncomplicated MI after six months or more of follow-up compared to the continuation of βB~     evaluated by the primary endpoint or death, MI, Stroke and rehospitalization for others~     cardiovascular reasons.~   "
5258|NCT03498053|"~     Rationale: The World Health Organization Framework Convention on Tobacco Control (WHO FCTC)~     aims for a regulatory strategy including the regulation of the contents of tobacco products~     (Article 9). Cigarette smoke includes more than 7000 chemicals which are harmful and cause~     tobacco-related diseases. In the future, regulation of these harmful cigarette constituents~     should be based on more chemical classes, as the WHO suggested. However, in order to~     introduce such class-based regulation, a scientific base is needed to define upper limits of~     allowed amounts of chemicals (groups) in cigarette smoke emissions and to ensure decreased~     harmful health effects due to cigarette smoking. To date, the causality between human~     exposure to specific cigarette smoke compounds and the harmful effects is unknown. The first~     step in closing the gap in knowledge between cigarette smoke exposure and developing~     tobacco-related diseases includes a proper determination of human exposure to cigarette smoke~     chemicals. This includes measuring smoking topography and inhalation. Smoking topography is~     how the smoker smokes the cigarette (puff volume, duration, flow etc). The goal is to link~     smoking behavior to smoke exposure, for 2 different cigarette brands. The participants will~     smoke their 'normal' brand Marlboro (experimental day 1) after which they receive the low~     TNCO (tar, nicotine and carbon monoxide) Marlboro Prime to smoke at home. A week later the~     experimental day (day 2) is repeated with this cigarette. On the last experimental day (day~     3), the participants will smoke the Prime cigarette while the ventilation holes of this~     low-TNCO cigarette are taped. Afterwards, the personal smoking profiles of the participants,~     and thus their individual exposures, will be mimicked in the lab using machine smoking. The~     observed smoking topography and inhalation parameters together give information about the~     exposure to smoke toxicants. In addition, this study is also designed to measure biomarkers~     of exposure in body fluids of smokers, such as nicotine and the most abundant cigarette smoke~     chemicals and their metabolites.~      Objective: We want to find out whether the individual habitudinal smoking topography of a~     smoker smoking his usual brand, and the changes between cigarettes over the day, can be~     compared to that of smoking a low-TNCO or high nicotine cigarette (i.e. the Marlboro Prime~     and Red Sun). In addition, differences in inhalation patterns are investigated. Next to that,~     the exposure will be connected to the nicotine and carbon monoxide levels in blood and/or~     urine. Also smoke toxicants (and metabolites) in exhaled air, saliva, urine and blood of~     smokers are determined.~      Study design: This prospective observational study monitors smokers in their habitudinal~     smoking during the day (for 10 hr) while smoking Marlboro, Marlboro Prime and Marlboro Prime~     taped cigarette, while during the day bodily fluids are sampled at several time points.~      Study population: This population consists of 18 Caucasian, healthy, adult males, aged~     between 25-34 years old. Participants should be used to smoke Marlboro (red/regular) for at~     least 3 years with a daily average of 13 to 25 cigarettes (about a package every day).~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: The participating smokers smoke according to their habitudinal smoking pattern,~     and are therefore not increasingly exposed to the harmful health effects of cigarette~     smoking. The invasive part of the study is their stay for 3 days (and 1 night when wanted) in~     a hotel, and the sampling of blood, saliva, urine and exhaled air.~   "
5259|NCT03498040|"~     Carcinoid Heart Disease (CHD) is a rare form of heart disease, occurring in over 50% of the~     patients with carcinoid syndrome. Pathophysiology, prognostic factors of development of~     Carcinoid Heart Disease and progression of disease remain unclear.~      This observational multicenter cohort study is designed to study the occurrence of Carcinoid~     Heart Disease in patients with differentiated carcinoid tumors, to describe numerous factors~     influencing the occurrence, severity, progression and long-term survival of patients with~     Carcinoid Heart Disease. Basic informations and detailed diagnosis informations (oncological~     and cardiac parameters), are collected by professional doctors. Clinical outcomes (onset of~     Carcinoid Heart Disease, cardiac surgery, related death) will be followed up every year or~     every six/three months if clinically indicated.~   "
5260|NCT03498027|"~     Whole blood samples will be collected from febrile patients presenting with fever of unknown~     origin and flu-like syndromes. Collection sites will consent patients and collect one (1) 4~     mL whole blood sample from adults and either (1) 2 mL pediatric whole blood sample or 0.5 mL~     whole blood sample collected in a micro collection container from pediatric patients from~     each patient enrolled into the study. Study site will test whole blood samples received from~     collection sites daily using the Applied Biosystems™ Bacillus anthracis Detection Kit. Data~     generated will demonstrate product specificity when testing febrile whole blood samples.~   "
5261|NCT03498014|"~     The investigators hypothesize that opioid prescription guided by patient pharmacogenetic~     profile will diminish opioid-associated undesirable effects by 50% and improve medication~     compliance.~   "
5327|NCT03497143|"~     Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the~     pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the~     pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery.~     Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological~     availability of medication. In this study the pharmacokinetic effects of bariatric surgery on~     lamotrigine are investigated.~   "
5262|NCT03498001|"~     Type II diabetes is a known risk factor for heart failure, particularly through the~     progressive development of diabetic cardiomyopathy. Cardiac metabolic parameters, including~     myocardial steatosis and epicardial fat, are altered in diabetic patients. The development of~     new anti-diabetics (incretins) has demonstrated protective cardiovascular effects independent~     of effects on glycemic control for the first time in the history of these therapies. Thus~     Glucagon-Like Peptide 1 (GLP-1) agonists improve the recovery of cardiac function after a~     heart attack and decrease atheromatous processes. It has also been demonstrated in a diabetic~     rat model that the administration of Liraglutide, a GLP-1 agonist, leads to normalization of~     myocardial steatosis associated with beneficial cardiac molecular remodeling involving~     pro-apoptotic, oxidative and metabolic processes. These beneficial cardiovascular effects~     were observed in the absence of any changes in blood glucose, insulin levels or body weight.~   "
5263|NCT03497988|"~     The purpose of the study is to determine the effect of intranasal OXT caloric intake and~     eating behaviors in otherwise healthy obese adolescents.~      The primary objective of this study is to determine the effects of intranasal administration~     of oxytocin on food intake in obese, pubertal or post-pubertal adolescents (13 to <18 years~     in girls, and 15 to <20 years in boys).~   "
5264|NCT03497975|"~     To investigate the anti-pruritic efficacy and safety of Nalbuphine ER (NAL ER) tablets in~     Prurigo Nodularis. Subjects will be randomized to NAL ER (or matching placebo) with the~     primary endpoint evaluation at Week 14. During the open label extension, subjects who~     received NAL ER will continue on NAL ER and subjects who received placebo will crossover to~     NAL ER.~   "
5265|NCT03497962|"~     The investigators' aim is to find out whether immune cells from patients with a severe chest~     infection will react ex vivo to a new immunomodulating peptide, P4 as part of augmented~     passive immunotherapy~      The investigators know that P4 treatment can successfully improve the efficiency of~     specialized immune cells responsible for killing bacteria. The investigators also know that~     P4 treatment is effective in healthy human volunteers but wish to extend this observation to~     patients that have infection, as immune cells may react differently in these patients. If~     this study is successful, the investigators hope to be moving closer to a new treatment~     against severe bacterial infections.~      The investigators plan to recruit patients admitted to the Intensive Care Unit (ICU) and~     healthy volunteers, using carefully established inclusion and exclusions criteria with severe~     community acquired pneumonia (CAP) and obtain both blood and (if clinically feasible), a~     bronchoscopy BAL sample (washing of lung tissue).~   "
5266|NCT03497949|"~     The incidence of hypotension perioperatively during operation of an acute hip fracture is~     unknown. As a surrogate factor the usage of vasopressor support is more adequate as the~     registration of vasopressor drugs are many times not complete in records. The investigators~     retrospectively investigated the anesthetic journals of 1100 patients with an acute hip~     fracture (AHF) noting confounding factors and the usage of vasopressors either by injections~     or infusions and then correlated these results to mortality at 30-, 90- and 365- days~   "
5267|NCT03497936|"~     The overall goal of this SBIR Phase II project is to reduce cancer rates by marketing a~     brief, easily implemented technology-based intervention that increases human papillomavirus~     (HPV) vaccination among Planned Parenthood and other clients. The intervention's innovative~     technology allows for the investigators' narrative videos to be presented along will reminder~     texts. It will be evaluated for use in waiting rooms and promises to overcome vaccination~     barriers among high risk but underserved low SES and minority populations.~   "
5268|NCT03497923|"~     Magnesium sulphate is regularly used in perioperative medicine. During and after general~     anesthesia, it enhances the effect of muscle relaxants because it reduces the liberation of~     acetylcholine at the neuromuscular junction. When administered immediately after spontaneous~     recovery of a neuromuscular block (NMB), magnesium may cause a recurrence of NMB and~     compromise patient safety.~      Rocuronium is a neuromuscular blocking agent which is frequently used to facilitate~     intubating and surgical conditions. At the end of the procedure, there are two ways to~     accelerate the reversal of a neuromuscular block induced by rocuronium: 1. Administration of~     neostigmine, an anticholinesterase agent and competitive antagonist; 2. Administration of~     sugammadex, a γ-cyclodextrin compound and specific encapsulator of rocuronium.~      The study is done in patients receiving rocuronium and either neostigmine or sugammadex for~     reversal of NMB. It is hypothesized that when sugammadex is used as an antagonist of a~     rocuronium-induced NMB, it prevents the reappearance of NMB when magnesium is injected,~     because sugammadex should inactivate all remaining rocuronium molecules and restore~     neuromuscular reserve of the neuromuscular junctions. Further more it is hypothesized that~     reversal with neostigmine will not prevent a magnesium-induced recurrence of NMB to the same~     extent. The primary objective of the study is to show that after reversal with sugammadex~     there is no or only very little re-occurrence of neuromuscular block after a magnesium~     perfusion. Furthermore we want to show that after reversal with neostigmine there is a~     re-occurrence of neuromuscular block.~   "
5269|NCT03497897|"~     The main purpose of this study is to assess preliminary efficacy and safety of LYS006 in~     patients with moderate to severe inflammatory acne and to determine if LYS006 has an adequate~     clinical profile for further clinical development.~   "
5270|NCT03497884|"~     Parkinson's disease (PD) patients have some problem with self-initiated movement task.~     Compared with health controls, task meta-analysis found that PD patients showed abnormal~     activation in pre-supplementary motor area (pre-SMA) and putamen. And the functional~     connectivity has already been reported between pre-SMA and putamen in 2013. Repetitive~     Transcranial Magnetic Stimulation (rTMS) is a sage and painless technique to activate~     cortical areas. The deep brain structure can be activated via stimulating superficial cortex~     by rTMS. For investigating the mechanism of self-initiated movement, this project is using~     functional magnetic resonance imaging (fMRI) to individualize the precise localization in~     motor area and combining rTMS to activate putamen.~   "
5328|NCT03497130|"~     This research is being done to evaluate the role of a regular skin care regimen comprising of~     a mild soap and moisturizer in improving dry skin and overall skin health. In this study, the~     investigators hope to learn the importance of regular skin care regimen in improving dry skin~     and overall skin health.~   "
8513|NCT03455439|"~     Evaluation of the risk factors associated with Heart Failure (HF) worsening (measured by~     hospitalizations and emergency visits because of HF exacerbations) in Spanish patients with~     Atrial Fibrilation and HF treated with rivaroxaban.~   "
5271|NCT03497871|"~     Despite the availability of evidence-based guidelines for disease management in patients with~     congestive heart failure (CHF), the uptake of these guidelines in clinical practice is~     sub-optimal and adherence rates are disappointing. Within the HeartMan project, a personal~     e-health system was developed to help CHF patients manage their disease, with the ultimate~     goal to improve health-related quality of life (HRQoL). The system uses wrist-band sensors to~     monitor patients' physical activity and physiological parameters. These data are connected to~     a decision support system, providing medical advice to patients concerning physical exercise,~     nutrition, medication intake, clinical measurements, environment management, and mental~     support. The decision support system is based on predictive models, clinical care guidelines~     and expert knowledge. The advice will be personalized according to each individual patient's~     medical and psychological profile, and will be presented to the patient through the user~     interface of a mobile application on a smartphone. A proof of concept trial with a 1:2~     (control:intervention) randomization protocol was designed. The sample size calculation was~     based on primary outcome data from the previous CHIRON project, showing that 90 patients are~     needed to show at least -5.8 (± 6 to 8 s.d.) beats/min difference in average daily awake~     heart rate difference - as a fundamental parameter correlating with patient reported HRQoL -~     with 90% power between the two groups. Data collection will include an estimation of exercise~     capacity based on a six-minute walking test, and questionnaire assessments using standardized~     instruments. The trial will be initiated in two countries. In order to account for possible~     dropouts, 60 patients will be enrolled in Italy and 60 in Belgium (20 control and 40~     intervention patients in each country). Target patients are stable ambulatory CHF patients~     (NYHA class 2-3; reduced left ventricular ejection fraction ≤40%). Eligible patients will be~     recruited by their treating physician from collaborating medical centers in both countries;~     they will be enrolled in the trial after giving informed consent for participation. After~     baseline assessment, patients will be randomized into either the intervention (duration of 6~     months) or control (usual care) condition. Data collection will be repeated at the end of the~     trial.~   "
5272|NCT03497858|"~     This study will assess whether there is a performance enhancing effect associated with~     hydrating with coconut water. There have been only two studies in the past that have examined~     this phenomenon, however these studies have limitations due to their design parameters.~     Kalman et al. (2012) .... while treadmill time to exhaustion is routinely used in laboratory~     studies, the use of a time trial test as the measure of exercise performance may be more~     appropriate. While Peart et al. (2016) stated: limitations to the exercise protocol~     employed here may have contributed to the absence of a performance improvement with coconut~     water.~   "
5273|NCT03497845|"~     The main purpose of this study is to assess the ability of H5 influenza virus vaccines and~     adjuvants present in the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS) to~     generate an immune response to homologous and to antigenically distant heterologous H5~     influenza virus strains.~      The study is designed to evaluate the safety and immunogenicity of vaccination strategies~     with homologous or antigenically distant heterologous H5 influenza virus vaccines~     administered with AS03 or MF59 adjuvant.~   "
5274|NCT03497832|"~     Proton Magnetic Resonance Spectroscopy (1H-MRS) is a magnetic resonance imaging (MRI)~     technique. It allows the quantification of cerebral metabolite concentrations. Currently,~     MRS-1H is used regardless of the examination schedule. However, it is not possible to say if~     the brain metabolite concentrations are stable over 24 hours. Thus, the main objective was to~     study the diurnal variation of cerebral metabolite concentrations in 1H-MRS in healthy~     subjects.~      Moreover, the investigators also want to investigate the association between choline~     concentrations (Cho, parameter reflecting membrane metabolism) in 1H-MRS and fractional~     anisotropy (AF) values, obtained with the diffusion tensor imaging sequence (DTI), in the~     white matter of the centrum ovale. The results obtained from this objective will allow to~     obtain reference values of an estimate of the association between Cho concentrations and AF~     values in healthy subjects. These data are intended to improve the diagnostic and therapeutic~     management of patients with neurological pathologies.~   "
5275|NCT03497819|"~     Pancreatic cancer patients receive chimeric antigen receptor (CAR) T cells against mesothelin~     (CARTmeso) or CD19 (CART19) cells administered at 3 days via pancreatic artery infusion or~     i.v. after preconditioning of cyclophosphamide. Both CART cells are autologous. CARTmeso~     cells target pancreatic cells which highly express mesothelin, while CART19 cells target~     tumor-associated B cells expressing cluster of differentiation antigen 19 (CD19) which are~     mostly immunosuppressive. The investigators hypothesize that this combination therapy may~     enhance the efficacy of CARTmeso cells in the body. Additionally, a medium dose of~     cyclophosphamide is used to enhance the engraftment of CART cells.~   "
5276|NCT03497806|"~     This is an open-label extension of CDI-001 (subsequently referred to as PRISM 3), and is~     evaluating the safety and efficacy in reducing recurrence of CDI in adults who had a CDI~     recurrence within 8 weeks of receiving CP101 or placebo in PRISM 3. Subjects who are~     experiencing recurrent CDI will undergo screening procedures. Subjects who meet eligibility~     criteria will be eligible to be enrolled in the extension study and administered CP101.~      Approximately 70 subjects will receive CP101. The treatment duration will be 1 day. Subjects~     will be monitored for recurrence of CDI, safety, and tolerability for 24 weeks following~     receipt of CP101. The primary efficacy and safety endpoints will be evaluated at 8 weeks post~     treatment, and all subjects will continue to be followed for an additional 16 weeks for~     safety and recurrence of CDI.~   "
5277|NCT03497793|"~     Skin-to-skin care (placing the nappy-clad baby on the mother's bare chest and draping both in~     a blanket) is known to benefit both baby and mother. Benefits to the baby include warmth,~     reduced crying, and stabilisation of heart rate, breathing and blood sugar, and promotion of~     breastfeeding while simultaneously reduces mother's anxiety, improves bonding, and increases~     breastmilk production. Although these benefits are even more pronounced for preterm, studies~     show most preterm babies do not receive adequate skin-to-skin care due to fears such as~     dislodging intravenous lines, ventilation tubes, monitor wires and concerns about safety and~     privacy. Measures are therefore required to increase maternal confidence and awareness and~     facilitate skin-to-skin care for preterm infants.~      SNUBY® (SNUggle baBY) is a purpose-built garment for facilitation of skin-to-skin care in~     preterm infants. It is made of comfortable, breathable bamboo fabric with an attractive~     appearance such that it can be worn as a normal garment.~      In addition, it has distinctive features that allow the baby to be placed in a specially~     designed pouch, in direct contact with the mother's skin, with supports for lines and tubes~     that may be attached to the baby. Although many garments are commercially available for~     mothers to carry babies, no such specially designed garment has ever been tested~     scientifically and none are specifically designed for preterm babies. In this observational~     study, the investigators will initially test the feasibility of using the SNUBY® in preterm~     infants by inviting five mothers-preterm infant pairs, with mother's written informed~     consent, to use the garment under direct supervision. Following this, the investigators will~     analyse the safety and acceptability of using it on a larger scale to facilitate skin-to-skin~     care in preterm babies. The investigators will gather information on the staff and mothers'~     knowledge of skin-to-skin care and their experience of using SNUBY®.~   "
5329|NCT03497117|"~     The purpose of this study is to use perfluorinated gas imaging to highlight regions of~     functional variation within the lungs of participants with cystic fibrosis (CF), and to~     correlate this with changes in spirometry, lung clearance index, and quality of life of CF~     subjects undergoing treatment for a pulmonary exacerbation.~   "
5278|NCT03497780|"~     The proposed study will establish novel relationships between intra-articular mesenchymal~     stem cell (MSC) recruitment, synovial inflammation, biomarkers of cartilage degeneration and~     joint inflammation, clinical patient factors, and downstream alterations in cartilage~     composition and morphology to provide novel insights into the pathoetiology of post-traumatic~     osteoarthritis (PTOA) after ACL injury and reconstruction. The study aims to enroll N=38~     total patients with primary, isolated rupture to their anterior cruciate ligament (ACL), who~     have agreed to participate in the study and who will undergo primary surgical reconstruction~     by an orthopaedic physician at our two sites. Patients will undergo baseline magnetic~     resonance imaging (MRI), baseline clinical evaluation, and undergo a baseline blood draw.~     Subsequent imaging and clinical evaluations will be longitudinally performed at several~     postoperative timepoints up to 12 months postoperatively.~   "
5279|NCT03497767|"~     20-40% of patients with NSCLC will develop brain metastases at some point during their course~     of disease. Osimertinib has demonstrated intracranial activity in EFGR mutated NSCLC with~     leptomeningeal disease in the phase 1 BLOOM study. Stereotactic radiosurgery (SRS) is one of~     the standard local treatment for patients with limited number of brain metastases. Currently,~     it is unclear whether adding SRS to Osimertinib will result in superior intracranial disease~     control in patients with EGFR mutated NSCLC with brain metastases diagnosed de novo or~     developed while on first line EGFR tyrosine kinase inhibitors (TKIs) such as Erlotinib and~     Gefinitib.~      The aim of this study is to compare the effects of Osimertinib alone versus SRS plus~     Osimertinib on intra-cranial disease control in EGFR mutated NSCLC with brain metastases~     diagnosed or developed while on first line EGFR tyrosine kinase inhibitors.~   "
5280|NCT03497754|"~     Study to assess the feasibility of an external ultrasound fixator (ProbeFix)~   "
5281|NCT03497741|"~     Association between plasma procalcitonin levels and positive blood cultures in critical~     illness patients in the ICU.~   "
5282|NCT03497728|"~     In this prospective study, we used Multiplex ligation-dependent probe amplification and~     next-generation sequencing technology to detect AZF microdeletion types accurately in~     selected genetic locus, and made correlation analysis with clinical treatment results.~   "
5283|NCT03497715|"~     The study will be an adaptive, 2 part, single dose, 5-way crossover gamma scintigraphy study~     in healthy subjects, to investigate the rate and site of tablet disintegration of various~     forms of Ibuprofen.~   "
5284|NCT03497702|"~     This is an exploratory interventional study that initiates chemotherapy with letrozole in~     patients with estrogen receptor positive/HER2-negative breast cancer preoperably.~   "
5285|NCT03497689|"~     This is a multicenter, open-label study to evaluate the dose of Orenitram® (treprostinil)~     Extended Release Tablets achieved at 16 weeks after a short-term course of Remodulin®~     (treprostinil) Injection in prostanoid-naive subjects with pulmonary arterial hypertension~     (PAH).~   "
5286|NCT03497676|"~     The purpose of this study is to determine the dosage for oral and IM Cabotegravir LA and IM~     Rilpiverine LA and evaluate the safety, acceptability, tolerability, and pharmacokinetics of~     oral and long-acting injectable cabotegravir and long-acting injectable rilpivirine in~     virologically suppressed HIV-infected children and adolescents.~   "
5287|NCT03497663|"~     This RCT aims to investigate the effect of an early family-based intervention (VIA Family)~     focusing on reducing risk and increasing resilience for children in families where at least~     one parent has a severe mental illness.The study is a randomized clinical trial including 100~     children age 6-12 with familial high risk.The children and their parents will be assessed at~     baseline and thereafter randomized and allocated to either Treatment as Usual or VIA Family.~   "
5288|NCT03497650|"~     This is a pilot randomised controlled trial investigating a combination of unilateral~     strength training (cross-education) and mirror therapy for the rehabilitation of lower limb~     impairment following a stroke. This study has been conducted as part of a PhD qualification~     at the Institute of Technology Sligo in Ireland with all assessments being conducted at the~     institute and all therapy sessions taking place at the participant's home. The study was~     conducted in conjunction with Sligo University Hospital and it attained ethical approval~     through the relevant University Hospital Ethics Committee.~   "
5289|NCT03497637|"~     This is a prospective, randomized, controlled, multicenter, open-label study designed to~     assess whether Pd/Pa is non-inferior to FFR when used to guide treatment of intermediate~     coronary artery stenosis~   "
5290|NCT03497624|"~     Patient Derived Xenografts (PDXs) are models to study tumor growth, response to anti-cancer~     therapies, and resistance to anti-cancer therapies. The purpose of this study is to develop~     up to 24 PDX models for ROS1-fusion driven cancers to be used for research purposes only.~     That is, these patient derived PDX models will have no immediate benefit to the patient from~     whom the tumor specimen was obtained. Rather, these PDX models will be used to inform the~     study of ROS1-fusion driven cancers at large.~   "
5291|NCT03497611|"~     There are patient related risk factors for PPI that can be identified and assessed in~     retrospective pooling of 1000+ TAVI patient datasets.~      Retrospective pooling of 6 datasets already available at participating centres (4 sites in~     Germany, 1 in Zwolle / The Netherlands, 1 in Linköping / Sweden).~      Additional assessment of calcifications using a CT data core lab. Statistical analysis of the~     obtained dataset with respect to the objectives of the registry.~   "
5292|NCT03497598|"~     In this trial, women with history of recurrent urinary tract infections (UTIs) will be~     followed over the course of 6 months. The women will be randomized either to D- Mannose or~     Placebo.~      The primary objective of this study is to investigate if treatment with D-mannose reduces the~     risk for a UTI recurrence compared to treatment with Placebo.~      H0: Women with history of recurrent UTIs treated with D-Mannose on average have the same~     number of recurrent UTIs over the course of 6 months compared to women treated with Placebo.~      H1: Women with history of recurrent UTIs treated with D-Mannose on average have fewer~     recurrent UTIs over the course of 6 months compared to women treated with Placebo.~   "
5293|NCT03497585|"~     This study explores whether it is feasible to use a newly developed activity pacing framework~     to standardise how activity pacing is instructed by healthcare professionals in~     rehabilitation programmes for patients with chronic pain/fatigue.~   "
8559|NCT03454841|"~     The aim of this study is to compare circadian variability of antiplatelet effect of prasugrel~     and ticagrelor maintenance doses during the initial days after acute myocardial infarction.~   "
5295|NCT03497559|"~     Stress induced by pain and anxiety is common in pediatric intensive care unit (PICU) patients~     and can impede the delivery of care as well as their recovery. Sedation/analgesia in PICU is~     usually achieved using narcotics and benzodiazepines. Excessive use of these drugs can put~     patients at risk for hemodynamic and respiratory instability, prolonged mechanical~     ventilation, withdrawal symptoms, and delirium. Non-pharmacologic measures for analgesia and~     anxiolysis may reduce the total medication requirement and their side effects. The use of~     non-pharmacologic interventions, including music, has been recommended by sedation guidelines~     for critically ill patients; however, it is not clear how these interventions should be~     provided. We plan to conduct a pilot 3-arm RCT to determine the feasibility of a music~     intervention and assess its effects on sedation/analgesia requirements in children admitted~     to PICU. Children will be randomly assigned to receive music, noise cancellation or control.~     Music will be delivered by headphones and an iPod. Music will consist on classical music~     selected by the study's pediatric music therapist. The noise cancellation group will receive~     the same headphones but without music. Clinical care of the participants, including use of~     sedation and analgesia drugs, will not be protocolized. Primary outcomes of this pilot trial~     is feasibility. Secondary outcomes are drug requirements for sedation and analgesia, and~     incidence of delirium. These requirements will be captured as a daily intensity score and~     intermittent dose (PRN) frequency. Mixed-effects models will be used to analyze the effect of~     the music on sedation/analgesia requirements.~   "
5296|NCT03497546|"~     Severe/morbid obesity is an international public health issue that importantly increases the~     risk of cardiovascular events and cardiovascular and all-cause mortality. Likewise,~     severe/morbid obesity increases the risk of illness, reduces quality of life, and raises~     health-care costs. Bariatric surgery is the election method for the treatment of~     severe/morbid obesity, resulting in significant weight loss and remission of comorbidities.~     However, a relatively large proportion of bariatric patients regain weight and continue to be~     at high risk for cardiovascular disease and premature mortality. A healthy lifestyle~     following bariatric surgery is essential for optimizing and maintaining weight loss.~     Observational studies suggest that physical activity following bariatric surgery might be~     associated with additional weight loss and more effective weigh loss maintenance over time.~     However, very little experimental evidence exists regarding the effects of supervised~     exercise on obesity-related outcomes in this specific population.~      The aim of the EFIBAR (Ejercicio FÍsico tras cirugía BARiátrica) randomized controlled trial~     is to determine the effects of a 16-week supervised concurrent (aerobic and strength)~     exercise intervention program on weight loss (primary outcome), body composition,~     cardiometabolic risk, physical fitness and quality of life (secondary outcomes) in patients~     with severe/morbid obesity following bariatric surgery.~      According to the study aims the investigators pursue the following hypothesis: Supervised~     exercise will result in larger weight loss than control.~   "
5297|NCT03497533|"~     This is a single arm, open-label, single-center, phase 1/2 study, to determine the safety and~     efficacy of TriCAR-T-CD19, an autologous tri-functional anti-CD19 chimeric antigen receptor~     (CAR)-positive T cell therapy, in refractory/Relapsed Non-Hodgkin Lymphoma (NHL).~   "
5298|NCT03497520|"~     The purpose of this study is to evaluate the effect of asymmetric spinal stabilization~     exercise on scoliosis~   "
5299|NCT03497507|"~     Shivering during a cesarean section can be quite uncomfortable for the patient as well as~     make it difficult for the anesthesiologist to obtain vital signs. The researchers will~     investigate whether or not applying pressure to the P6 acupressure point during a cesarean~     section can treat shivering. The hypothesis is that shivering will be alleviated with~     acupressure.~   "
5300|NCT03497494|"~     Obesity and related metabolic diseases have become a chronic disease that is a threat to~     human health. Bariatric surgery can effectively and long-term reduce excess body weight and~     relieve related metabolic diseases, including type 2 diabetes. Laparoscopic gastric bypass~     surgery and laparoscopic sleeve gastrectomy are commonly used in bariatric surgery.~     Laparoscopic sleeve gastrectomy due to simple operation, good weight loss, and metabolic~     disease control effect, which is more widely used. However, there are several studies that~     show an increased chance of gastroesophageal reflux disease after laparoscopic sleeve~     gastrectomy. Long-term gastroesophageal reflux may lead to Barrett's esophagus or esophageal~     cancer. Nowadays, the cause of gastroesophageal reflux disease after sleeve gastrectomy is~     not clear and precautionary measures are not precise.~      In this study, prospective randomized controlled trials were conducted to explore the~     possible causes of gastroesophageal reflux after sleeve gastrectomy and to explore ways to~     prevent gastroesophageal reflux disease after sleeve gastrectomy.~   "
5301|NCT03497481|"~     The purpose of the study is to determine whether neopterin can be dosed in the fluid of the~     eye's anterior chamber for patient with non-inflammatory and non-infectious ophthalmic~     pathology.~   "
5302|NCT03497468|"~     Multiple Sclerosis (MS) is inflammatory, demyelinating and autoimmune disease of the central~     nervous system. It is usually seen with relapses and genetic and environmental factors play a~     role in the etiology. Neurological symptoms seen in MS restrict the patient's daily activity~     and social role participation. Mobility problems and fatigue are the most important reasons~     of role limitations and decreased quality of life. The importance of exercise training in~     disease management has been emphasized in recent years. However, few studies have~     investigated the effects of task-oriented trainings on symptoms of the disease. The aim of~     this sudy is to investigate the effects of task-oriented training additional to combined~     exercise training on functional capacity, mobility, balance, fatigue and quality of life in~     patients with MS.~   "
5309|NCT03497377|"~     The objective of this study is to evaluate a radiolabeled urea-based small molecule inhibitor~     of prostate-specific membrane antigen (PSMA), [18F]DCFPyL (DCFPyL) PET/CT (or PET/MRI imaging~     if available) for detection of metastatic prostate cancer. PSMA is a well characterized~     histological marker of prostate cancer tumor aggressiveness and metastatic potential.~     Preliminary first-in-human studies demonstrate high specific uptake of a first generation~     less avid compound, DCFBC, in metastatic prostate cancer and demonstrated feasibility for~     prostate cancer metastatic detection. Investigators propose to assess the ability of DCFPyL~     PET to detect metastatic prostate cancer by visual qualitative and quantitative SUV analysis.~     Correlation will be made to sites of suspected metastatic disease detected by ultra sensitive~     but less specific [18F]Sodium Fluoride (NaF)-PET/CT imaging for prostate cancer.~   "
5303|NCT03497455|"~     This feasibility study aims to evaluate the use of the BARCO NV digital dermatoscope (non-CE~     marked device) in the skin cancer clinic. All eligible patients attending the Dermatology~     outpatient skin cancer clinic will be invited to participate. Patients who consent to the~     study will undergo standard care which will include medical photography of skin lesion(s) and~     appropriate management as determined by the Consultant Dermatologist in clinic. In addition~     to standard care, patients will undergo photography of the same lesion(s) using the BARCO NV~     digital dermatoscope. There will be no other intervention and no additional hospital visits~     in relation to the study. Use of the device will not influence the clinical management of the~     patient.~      A detailed experience questionnaire will be administered to all clinicians using the BARCO~     device to explore their opinion on its ease of use and features.~      All standard macroscopic & dermoscopic images will be taken by OUH medical illustration~     department and stored on the 'Fotoweb' database (in keeping with current standard practice).~     Trained Dermatology Consultants, Dermatology Registrars, Research nurses or Medical~     Photographers, will take BARCO NV device images. A database of all BARCO images will be~     collected and stored on a dedicated NHS computer separate from the patient clinical record.~     Standard medical photography images will be stored on Fotoweb as per standard NHS clinical~     care.~      Data will be anonymised and collated and then sent securely to BARCO for further analyses to~     enable optimization of the BARCO device and for development of diagnostic algorithms in the~     future.~   "
5304|NCT03497442|"~     Asian Flushing Syndrome (AFS) is a genetic disease affecting approximately 70% of patients of~     East Asian descent characterized by severe flushing with minimal ethanol consumption. This~     reaction is cosmetically unattractive and socially limiting. Many Asian patients avoid~     drinking alcohol on dates, at weddings, and during business events because of this reaction~     and the perception of being drunk or alcoholic.~      Ethanol is normally metabolized to acetic acid by two enzymes. The first enzyme, alcohol~     dehydrogenase (ADH) converts ethanol to acetaldehyde. The second enzyme, aldehyde~     dehydrogenase 2 (ALDH2) converts the toxic acetaldehyde to harmless acetic acid. When ADH~     function is increased or ALDH2 function is decreased, the toxic intermediate acetaldehyde~     accumulates resulting in cutaneous flushing. Over 70% of East Asians have genetic~     polymorphisms in either ADH or ALDH2 leading to intense flushing with ethanol consumption.~      There are no effective topical treatments for the Asian Flushing Syndrome. Oral~     antihistamines have been used with some success in treating symptoms of Asian Flushing~     Syndrome; however these can have sedating effects and may be dangerous in combination with~     alcohol.~      Brimonidine is a selective α2-adrenoceptor agonist that acts through vasoconstriction and is~     commercially available in a topical gel. This topical treatment is FDA approved for the~     indication of facial flushing and has a long history of safety in human subjects.~   "
5305|NCT03497429|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of~     Niraparib in Japanese patients with advanced solid tumors.~   "
5306|NCT03497416|"~     Preoperative anemia is a known risk factor for morbidity, mortality and increased healthcare~     resource utilisation. The Investigator's previous study demonstrated the rate of preoperative~     anemia in Singapore General Hospital (SGH) to be at 26.6%. The rate is highest in the elderly~     group which stands at 49.9%. The main objective of this study is to investigate the~     perioperative morbidity and mortality, blood transfusion rate, healthcare outcomes and~     patient-centric outcomes among anemic elderly patients undergoing major surgery. The~     investigators hypothesize that elderly patients who undergoes major abdominal surgery with~     preoperative anemia will have higher composite morbidity and mortality rates (primary~     outcome), longer length of hospital stay, higher blood transfusion requirements and lower~     health-related quality of life (HRQoL) at 1, 3 and 6 months (secondary outcomes) when~     compared to elderly patients without preoperative anemia. The investigators will conduct a~     prospective observational study of 450 consecutive patients above 65 years, who are~     undergoing elective major open abdominal surgery in SGH over 12 months. Baseline clinical~     assessment, including iron studies for anemic patients, will be done within 14 days prior to~     surgery. To determine the primary outcome, patients will be followed up prospectively for 30~     days from the day of surgery. This will be done via a mixture of medical records review and~     phone interview. For secondary outcomes, the length of hospital stay and readmissions for any~     reason within 3 and 6 months will be recorded.~      HRQoL questionnaires will be done through phone calls by a study team member. Findings from~     this study will hopefully fill the knowledge gaps such as how anemia impacts elderly people~     in terms of perioperative morbidity, mortality, postsurgical quality of life and their~     eventual return to the community as well as providing local data on the healthcare resource~     utilisation in this group.~   "
5307|NCT03497403|"~     Two different surgical protocols for socket preservation were compared. Soft and hard tissue~     outcomes were measured clinically and radiographically at baseline and six months post~     operatively.~   "
5308|NCT03497390|"~     Obese type 2 diabetic patients are difficult to treat with many unmet needs requiring complex~     treatment regimens, intensive counselling and emotional support. Traditional anti-diabetic~     drugs, such as sulphonylureas and insulin, are known to have side-effects of weight gain and~     can offset the benefits of glycemic control and increase cardiovascular risks. Aside from~     these therapeutic challenges, psychological needs of these obese diabetic patients due to~     anxiety, stigmatization, stress, depression cannot be adequately addressed in a busy clinic~     setting. Here, the investigators propose to conduct this translational study aiming to~     compare the effects of a multi-component care program with personalized drug regimen~     augmented by behavioural therapy with psychological support and peer influence, led by a~     diabetes specialist team on metabolic control and psychobehavioural parameters in obese type~     2 diabetic participants with poor glycemic control (glycated hemoglobin [HbA1c]>8%) versus~     usual care. The 1-year multi-component program will be followed by a 1-year observational~     period in the EMERALD group. Outcome measures will be assessed in all participants in the~     EMERALD and usual care group at 1-year and 2-year. The primary outcome will be glycemic~     control as measured by HbA1c compared to baseline. Secondary outcomes include control of~     blood pressure, low-density lipoprotein cholesterol, body mass index and other obesity~     indices compared to baseline.Tertiary outcomes include hospital admissions, hypoglycaemic~     episodes, psychobehavioural parameters as measured by questionnaires and all clinical~     endpoints such as incident cardiovascular-renal events and mortality. A per-protocol analysis~     will be performed to assess the correlations between adherence to these activities and~     improvement in metabolic control.~   "
5322|NCT03497208|"~     A comparative study for the surgical treatment of vitiligo in which the same patient will~     receive in acromic and symmetric lesions of vitiligo dermabrasion with micro needling and on~     the other side dermabrasion with micro needling followed by the application of cell~     suspension (melanocytes and uncultured keratinocytes). These cells will be removed from the~     own patient through the skin of the scalp. After the surgical procedure, patients will be~     submitted to UVB-NB phototherapy sessions (twice a week) and evaluated for repigmentation of~     vitiligo lesions at 14 and 24 weeks of treatment.~   "
5310|NCT03497364|"~     Hypotension is a common complication in pregnant women after spinal anesthesia and related~     with the dose of local anesthetic. Injecting small dose local anesthetic into subarachnoid~     space can decrease the incidence of hypotension, but increase the risk of incomplete~     analgesia and muscle relaxation. The investigators hypothesize there is an optimal dose of~     bupivacaine and ropivacaine for subarachnoid injection in pregnant women, which can cause~     enough anesthesia and obviously decrease the incidence of hypotension without prophylactical~     prehydration and vasopressors. To verify this hypothesis, full-term pregnant women who were~     scheduled for elective cesarean section were recruited.Combined spinal-epidural anesthesia~     was performed for pregnant women after written informed consents. The dose of bupivacaine or~     ropivacaine is small and depends on height of pregnant women. The blood pressure, heart rate,~     respiratory rate, SpO2 and fetal heart rate were recorded and the blood flow volume of~     uterine artery was monitored The sensory and motor block were evaluated. After delivery,~     umbilical blood samples were taken for blood gas analysis. APGAR scores and neurological~     behavior of infant were evaluated and recorded. In the intraoperative period, side-effects~     and requirement for sedation, epidural injection or general anesthesia were noted. The~     quality of anaesthesia (judged by the anaesthetist), the quality of muscle relaxation (judged~     by the surgeon) and the degree of intraoperative comfort (judged by the patient) were~     recorded as excellent, good, fair or poor.~   "
5311|NCT03497351|"~     SVV is clinically affected by a variety of factors, such as abdominal pressure, body~     position, tidal volume, type and temperature of liquid treatment, etc. There are few reports~     on the effects of drugs on SVV.~      In clinical anesthesia, surgical stimulation and stress can affect patient hemodynamic~     stability, used in intraoperative vascular active drug is inevitable, they shrink or dilate~     blood vessels, speed up or slow down the heart rate, makes the ventricular preload and~     corresponding changes in the SV. Now, there is a study on SVV and PPV in patients with~     hypertension, but there are few reports on the effect of blood pressure drugs on the changes~     in patients' threshold.~   "
5312|NCT03497338|"~     Effective and normative anticoagulation is one of the most important components of~     Extracorporeal membrane oxygenation (ECMO) management. Excessive anticoagulation may lead to~     hemorrhage, which is the most common and serious complication. Currently, the most common~     factors for monitoring anticoagulation of ECMO are the activated clotting time (ACT) and~     activated partial thromboplastin time (APTT). However, there is a lack of a unified~     understanding of the related monitoring measures, monitoring targets, and bleeding risk~     assessments, which have been chosen mainly because of experiences reported by various ECMO~     centers or the results of retrospective studies.Therefore, anticoagulation strategies need to~     be improved. Our research have found ECMO anticoagulation management should be transformed~     from monitoring only the APTT/activated clotting time (ACT) to considering the entire~     coagulation process. To maintain thrombosis ability and PLT function within normal ranges may~     help reduce hemorrhage rates and improve prognoses. This randomized controlled study aim to~     develop the safety and efficacy new anticoagulation strategies of VV-ECMO.~   "
5313|NCT03497325|"~     The aim of this study is to evaluate the efficacy of intramuscular autologus platelet rich~     plasma on uterine wound healing after primary cesarean section~   "
5314|NCT03497312|"~     To assess Oral health related quality of life (OHRQOL) after full mouth rehabilitation under~     GA in a group of Egyptian children with special healthcare need.~   "
5315|NCT03497299|"~     Tobacco smokers with schizophrenia are known to be resistant smokers, with high rates of~     smoking and inability to quit in the long-term, often related to smoking relapse. This may~     relate to problems with frontal lobe function associated with schizophrenia, which make these~     patients have great difficulty in dealing with smoking withdrawal, urges and cravings. The~     current study will develop a combination approach that takes advantage of brain stimulation~     of the frontal lobes (repetitive transcranial magnetic stimulation (rTMS), in combination~     with the anti-smoking drug varenicline, to prevent smoking lapse using a well-established~     human laboratory method. Results from this study may have important implications for~     developing novel treatment approaches for smokers with schizophrenia.~   "
5316|NCT03497286|"~     The primary objective of this study is to determine whether the NurturePA text-based~     mentorship program reduces maternal stress and depressive symptoms, increases maternal~     knowledge, and increases engagement in language and literacy practices among new mothers~     relative to the control condition of periodic informational texts at the four-month data~     collection point.~   "
5317|NCT03497273|"~     The purpose of this study is to assess the safety and tolerability of itacitinib in~     combination with corticosteroids in Japanese subjects with Grades II to IV acute~     graft-versus-host disease (aGVHD).~   "
5318|NCT03497260|"~     To determine and compare the time-to-hypoglycaemia (defined as plasma glucose <3.9mmol/L) in~     individuals with type 1 diabetes treated with ultra-Long acting insulin degludec during~     aerobic exercise with or without prior ingestion of a single oral fructose load.~   "
5319|NCT03497247|"~     To compare two group psychological interventions for Gambling Disorder in terms of~     effectiveness and efficacy. One group is based in cognitive-behavioral therapy (TAU) and the~     other group is based in TAU with Mindfulness-Based Relapse Prevention (Chawla, Marlatt &~     Gordon, 2011). Both interventions are composed by 14 weekly sessions, and follow-up to a~     month, three months, six months, one and two years.~   "
5320|NCT03497234|"~     A multi-centered, prospective study, involving pregnant women presenting to the labor and~     delivery unit of collaborating clinical study sites with preterm labor and intact amniotic~     membranes with and without suspected Intra-Amniotic Infection (IAI).~   "
5321|NCT03497221|"~     The safety of the patient using a nasoenteral tube depends on the constant evaluation of the~     nursing team. The most implemented strategies for safe practice are education interventions,~     however, seem insufficient to change behavior. Active methodologies may be more promising~     alternatives for the development of these competencies. The objective is evaluate the effect~     of an isolated education intervention and combined with a visual identity campaign on the~     safe practice in the use of nursing care to the patient in use nasoenteral tubes. The~     clinical trial will be carried out in 2017, in a university hospital. Two profiles of~     participants will be included in the study: the first one refers to the nursing technicians~     of the hospital areas, part of them will receive a set of interventions, and the second one~     refers to the patients in use nasoenteral tube, considering that the effect of intervention~     will be measured by assessing compliance with care routines.~   "
5330|NCT03497104|"~     Paracetamol overdose is one of the most common medical emergencies. Annually in the UK,~     100,000 people seek medical attention and 50,000 need hospital admission. Treatment is with~     the antidote acetylcysteine (NAC), which is effective but takes 21 hours to administer~     intravenously and frequently produces adverse reactions. .~      Current tools that are used to decide who needs treatment are inadequate. We have identified~     and validated new blood tests that accurately identify those patients at risk of liver injury~     by quantifying the fundamental in vivo toxicity mechanisms.~      This study aim to gain further samples in order to develop a new point-of-care test~     specifically for the detection of liver damage.~   "
5331|NCT03497091|"~     This is a retrospective review of data documented in medical records.~   "
5332|NCT03497078|"~     Comparison of quality image with a new LEHRS GE collimator vs standard LEHR Siemens~     collimator on bone scintigraphy.~   "
5333|NCT03497065|"~     Objective: This study investigated how patients' knowledge, attitude, and perceptions~     influence their oral hygiene practices as well as peri-implant health. Materials and Methods:~     Participants with single implant crowns placed in 2007-2011 completed a questionnaire that~     examined their knowledge, attitude, and perceptions on oral hygiene practices and~     peri-implant health before receiving a periodontal examination, prophylaxis, and oral hygiene~     education. Clinical parameters recorded were peri-implant probing depths and plaque index,~     width of keratinized mucosa, implant crown characteristics, reason for tooth loss, and~     diagnosis of peri-implant health.~   "
5334|NCT03497052|"~     The aim of this non-interventional study is to compare the blastulation rate per fertilized~     oocyte in two different single step culture media commercially available (GEMS and Irvine~     culture media).~   "
5335|NCT03497039|"~     The purpose of this study is to evaluate the exposure of diclofenac in the plasma and in the~     knee joint following topical administration of DDEA gel 4 gram (g) applied twice daily for 7~     days~   "
5336|NCT03497026|"~     In this study, the performance related to the use of the novel Robotic Endoscopy Platform~     during bronchoscopic procedures will be evaluated.~   "
5337|NCT03497013|"~     The aim of the study was to evaluate the efficacy, safety, and cognitive function of~     transcranial direct current stimulation (tDCS) in chronic schizophrenia patients with tardive~     dyskinesia (TD).~   "
5338|NCT03497000|"~     OCTA-guided PDT is as safe and effective as ICGA-guided PDT in the treatment of acute central~     serous chorioretinopathy. Or OCTA-guided PDT is more effective than ICGA-guided PDT in the~     treatment of acute central serous chorioretinopathy, safe as well.~   "
5339|NCT03496987|"~     The purpose of this study is to determine if there are any differences in terms of safety,~     pain, or drainage speed between thoracenteses via manual drainage vs vacuum suction.~   "
5340|NCT03496974|"~     Phase 2, Open label, dose escalation study of two dose cohorts of MABp1 in patients with~     moderate to severe atopic dermatitis. The study is multicenter, and will consist of two dose~     levels: MABp1 administered subcutaneously at a dose of 200 mg weekly (4 doses) and MABp1~     administered subcutaneously at a dose of 400 mg weekly (4 doses). Patients will be followed~     for 6 weeks to allow for assessment of safety and preliminary efficacy.~   "
5341|NCT03496961|"~     This study is to disclose the mechanism of characteristic Tao yin exercises regulate Chronic~     Fatigue Syndromes based on Brain-Gut Axis.Explore the clinical manifestation of Chronic~     Fatigue Syndromes, changes of neurotransmitter and central brain function. Then provide some~     new methods of treating Chronic Fatigue Syndromes.~   "
5342|NCT03496948|"~     Peripheral artery disease (PAD) is the third most prevalent cardiovascular disease worldwide,~     with over 200 million people affected. Most prominent symptom is leg pain while walking known~     as intermittent claudication. Based on the currently existing gaps in the management of~     intermittent claudication, the objective of the this study is to explore the clinical~     effectiveness and cost advantage of TeGeCoach, a 12-month long home-based exercise program,~     compared to usual care. TeGeCoach consists of telephone health coaching, remote walking~     exercise monitoring based on wearable activity monitors and intensified primary care. It is~     hypothesized that TeGeCoach will improve functional outcomes and will reduce total health~     care costs.~   "
5343|NCT03496935|"~     The investigators propose a randomized controlled trial to examine whether tunneled dialysis~     catheters should be first-line for acute kidney injury requiring renal replacement therapy~     (AKI-RRT) in the critical care setting, barring any clinical contraindications, compared to~     non-tunneled access. This randomized controlled trial will include patients admitted to an~     intensive care unit (ICU) at Brigham and Women's Hospital (BWH). The investigators will~     randomize all eligible consented incident patients with AKI requiring renal replacement~     therapy either to tunneled dialysis catheter or non-tunneled dialysis catheter placement. The~     inclusion criteria encompasses all adult patients in the BWH ICUs with an incident AKI~     requiring renal replacement therapy. The investigators' hypothesis is that the rate of~     overall complications is lower with tunneled dialysis catheters compared to non-tunneled~     catheters.~   "
5344|NCT03496922|"~     Participants will be given the opportunity to purchase ventilated, unventilated, and~     alternative nicotine products at different prices using an account balance based on their~     typical, daily nicotine product purchasing. Additionally, account balances will differ across~     trials.~   "
5345|NCT03496909|"~     A quarter of a million women will develop breast cancer (BC) in this year alone. Many of~     these women will have side effects as a result of their breast cancer treatment. Radiation~     Fibrosis Syndrome (RFS) is a common complication from breast cancer treatment that~     progressively changes tissue and can cause decreased function, pain, and range of motion. The~     PhysioTouch is a hand held device that can be used to treat RFS and may improve the treatment~     of fibrotic tissue. This pilot randomized controlled trial aims to determine the efficacy of~     using the PhysioTouch in addition to current standard of care for treatment of BC-related~     RFS.~   "
5346|NCT03496896|"~     Hospital rehospitalizations within 30 days are frequent and represent a burden for the~     patients, but also for the entire health care system. This study evaluates the impact of an~     intervention targeted to high-risk medical patients in order to reduce their risk of~     rehospitalization. Half of the patients will receive a set of interventions before and after~     their hospital discharge, while the other half will receive usual care.~   "
28355|NCT03195829|"~     This non-pharmacological interventional feasibility study evaluate a computerized cognitive~     stimulation program in elderly with mild cognitive impairment.~   "
5347|NCT03496883|"~     The objective of the rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time~     (FASTEST) Trial is to establish the first treatment for acute spontaneous ICH within a time~     window and subgroup of patients that is most likely to benefit. Our central hypothesis is~     that rFVIIa, administered within 120 minutes from onset with an identified subgroup of~     subjects most likely to benefit, will improve outcomes at 90 days as measured by the modified~     Rankin score (mRS) and decrease ongoing bleeding as compared to standard therapy~   "
5348|NCT03496870|"~     This is a phase 1, open-label study to assess the pharmacokinetics, pharmacodynamics, safety,~     and tolerability of opicapone when administered orally once daily for 14 days as adjunctive~     therapy to carbidopa/levodopa in subjects with Parkinson's disease.~   "
5349|NCT03496857|"~     The aim of this study is to valuate the effects of LED photobiomodulation on analgesia during~     labor.ight-emitting diode (LED) photobiomodulation is an effective and noninvasive~     alternative to pharmacological methods.n total, 60 women in labor admitted to a public~     maternity hospital will be selected for a randomized controlled trial. The participants will~     be randomized into two groups: intervention group [analgesia with LED therapy (n = 30)] and~     control group [analgesia with bath therapy (n = 30)].~   "
5350|NCT03496844|"~     Determine diagnostic accuracy of Axumin-PET positive bone lesion by confirmatory bone biopsy.~   "
5351|NCT03496831|"~     Background The risk for hospitalized infection (i.e. infection leading to hospitalization) in~     patients with inflammatory arthritis (rheumatoid arthritis (RA), psoriatic arthritis (PsA) or~     axial spondyloarthritis (axSpA) treated with biological drugs is known to be increased~     compared to the background population. In daily clinical practice, there is a need for a~     simple way to assess the absolute risk for hospitalized infection in individual patients~     based on easily available information such as age, diagnosis, functional status,~     comorbidities and medication. This risk estimate will be useful in clinical decision making~     e.g. when advising patients on whether or not to initiate biologic therapy or when advising~     patients on influenza or pneumococcal vaccination.~      Objectives The objectives are 1) to assess the risk for hospitalized infection (infection~     leading to hospitalization) in patients with inflammatory arthritis during 12 months of~     follow-up after initiating treatment with their first biological drug (bDMARD) with the risk~     in the general population, and 2) to develop a simple, clinically useful algorithm that~     allows prediction of the risk of hospitalized infection in individual patients.~      Methods Observational cohort study based on existing data in: The Danish Rheumatology~     Register (DANBIO), The Danish National Patient Register, The Danish National Prescription~     Register and The Danish Register of Causes of Death. All patients registered in DANBIO with~     RA, PsA or axSpA who initiated treatment with their first biological drug between January 1,~     2006 and December 31, 2016 will be identified. Baseline predictors and outcomes (hospitalized~     infection or death) during 12 months of follow-up are obtained. Logistic regression analysis~     and 10-fold cross-validation will be used to develop and internally validate the prediction~     model.~   "
5352|NCT03496818|"~     It is often suggested that lymphatic vessels are ineffective in transporting cargo in Crohn's~     disease. Our own work on surgically resected tissue supports this concept (1), but the~     concept has not been directly tested. Chylomicrons are packaged lipids from the diet with an~     obligatory absorption route through the lymphatic vasculature to reach host plasma. This~     protocol takes an approach to directly quantify chylomicron secretion using a fatty meal that~     incorporates stable isotopic tracers for trioleate and cholesterol in the meal. We will~     collect baseline plasma and then plasma every 30 minutes for 5.5 hours to chart the kinetic~     and magnitude of chylomicron secretion and transport in all subjects using mass spectrometry~     analysis. We will characterize a wide variety of parameters on the chylomicrons as well using~     ELISA. Infusions i.v. of stable isotope labeled triglyceride and glycerol will allow us to~     consider whether there are changes in VLDL metabolism that could account for differences in~     chylomicron handling once the chylomicrons are secreted into plasma. Collection and analysis~     of breath samples will also be carried to normalize against possible incomplete lipid~     absorption in some subjects.~   "
5353|NCT03496805|"~     It is estimated that one-third of the more than 7 million deaths from cancer worldwide are~     attributable to potentially modifiable risk factors, with 374,000 deaths preventable through~     diet modification alone. Diet supplementation for the prevention or treatment of cancer is~     attractive, as implementation is relatively easy, even in populations with reduced incomes~     and resources. Grape extracts or active components isolated from grapes have received~     attention as chemopreventive or therapeutic agents based upon their anti-proliferative,~     anti-inflammatory, and anti-oxidant properties. Evidence from preclinical trials also~     suggests that muscadine grape products may decrease systemic inflammation. This study builds~     upon promising preclinical and clinical evidence to determine if the addition muscadine grape~     extract (MGE) to androgen deprivation therapy (ADT) improves symptoms in men with prostate~     cancer.~   "
5354|NCT03496792|"~     This research is being done to find out whether distension of veins in legs will cause a rise~     in blood pressure (orthostatic hypertension).~   "
5355|NCT03496779|"~     This study is an open label, multicenter phase 2 study. The primary objective of the study is~     to determine the efficacy of brentuximab vedotin in patients treated by gemcitabine for~     relapsed or refractory peripheral T-cell lymphoma in term of overall response rate assessed~     after 4 cycles of treatment according to the international response criteria for malignant~     lymphoma (Lugano Classification 2014 - CT-Based Response).~   "
5356|NCT03496766|"~     This Phase II study consists of 2 parts: 1) pre-screening phase and 2) treatment phase.~      The pre-screening phase will investigate the presence of HRAS mutations in subjects with a~     histologically or cytologically confirmed diagnosis of squamous non-small cell lung cancer~     (SQ-NSCLC). Subjects may participate in the pre-screening phase at initial diagnosis or~     following prior lines of therapy for SQ-NSCLC.~      The treatment phase will investigate the antitumor activity in terms of ORR of tipifarnib in~     subjects with locally advanced squamous non-small cell lung cancer (SQ-NSCLC) with HRAS~     mutations and for whom there is no curative therapy available.~   "
5357|NCT03496753|"~     Treatment options for nipple fissures include drug therapy with antifungal and antibiotics,~     topical applications of lanolin, glycerin gel, creams and lotions, the milk itself, hot~     compresses and silicone nipple shields. Studies involving a light-emitting diode (LED)~     therapy have demonstrated anti-inflammatory properties, the enhancement of the wound repair~     process and the control of pain.~   "
5358|NCT03496740|"~     Pain after hypospadias surgery is a challenging issue to solve for anesthesists. Many~     different analgesia techniques were defined in literature for this purpose. The investigators~     have implemented application of ultrasound guided dorsal penile nerve block into practice for~     these type of surgeries. Main purpose of this study is to compare the efficacy of nerve~     stimulator guided pudendal nerve block with ultrasound guided dorsal penile nerve block for~     postoperative analgesia after hypospadias surgery.~   "
20077|NCT03304171|"~     The purpose of this study was to examine the relationship between indices of overall diet~     quality and incident breast cancer risk in a large prospective cohort of women.~   "
5359|NCT03496727|"~     Ultrasound-guided SAPB is a facial plane block which maintained analgesia with blockade of~     lateral branches of intercostal nerves at above or below serratus plane muscle. There are few~     cases and studies in the literature reporting successful analgesia provided by SAPB in VATS~     operations. The serratus plane block is used in our clinic for postoperative analgesia in~     VATS operations. The aim of this study was to evaluate the postoperative pain scores and use~     of analgesia in patients performed with the serratus plane block in VATS operations in a~      1-year period.~   "
5360|NCT03496714|"~     Research on decreasing safety behaviors in therapy has been restricted to treatments for~     other anxiety disorders and has not included PTSD. In order to address this gap and to~     develop a widely accessible, cost-effective prevention, an internet-based, three-arm~     randomized secondary PTSD prevention trial is proposed. Self-help psychoeducation on common~     reactions to trauma and eliminating safety behaviors will be employed for participants who~     have recently experienced a traumatic event. Participants will be randomized to receive (a)~     psychoeducation on trauma symptoms only, (b) combined psychoeducation on trauma symptoms and~     eliminating safety behaviors, or (c) monitoring only control. All participants will monitor~     safety behaviors and trauma symptoms weekly for eight weeks. Psychoeducation materials will~     be handouts and videos administered online via REDCap.~      It is hypothesized that participants in both psychoeducation conditions will have a lower~     incidence of PTSD, threat appraisal, and safety behaviors than participants in the~     monitoring-only control. It is also hypothesized that participants who receive combined~     psychoeducation on trauma symptoms and fading safety behaviors will have a lower incidence of~     PTSD, threat appraisal, and safety behaviors at Weeks 4 and 8 than will participants who~     receive psychoeducation on trauma symptoms only or participants in the monitoring-only~     control. It is further hypothesized that the effects of combined psychoeducation on~     preventing PTSD and threat appraisal will be mediated by decreased use of safety behaviors.~     Finally, it is hypothesized that combined psychoeducation on trauma symptoms and fading~     safety behaviors will be more effective in preventing PTSD for participants with higher~     levels of safety behaviors or threat appraisal at baseline. If effective, this secondary~     prevention program could be distributed widely to people who have recently experienced a~     trauma to prevent their development of PTSD.~   "
5361|NCT03496688|"~     Objectives: The aim of the study was to compare histological and histomorphometric results of~     six bone substitute materials used as graft in two-stage maxillary sinus augmentation model,~     after 6-month-healing.~   "
5362|NCT03496675|"~     This study evaluates the effectiveness of two music-based approaches - group music therapy~     and recreational choir singing - for reducing depression symptoms in people living with~     dementia. It also examines mechanisms and heterogeneity of treatment effects.~   "
5363|NCT03496662|"~     The purpose of this research study is to learn more about a new combination of drugs being~     given to treat pancreatic cancer. The drugs being tested are BMS-813160, nivolumab,~     gemcitabine, and nab-paclitaxel. The investigators will be looking at both the side effects~     and the way the disease responds to treatment.~   "
5364|NCT03496649|"~     Pubalgia is a pain syndrome located in the groin area. This syndrome is mainly described in~     young male athletes and typically affect the superficial muscles defining the boundaries of~     the femoral triangle, i.e. gracilis, pectineus, and especially adductor longus, and less~     commonly the deep muscles.~      Clinically, the pain is located in the inner aspect of the thigh, where the tendons attach~     onto the pubic symphysis. It is usually unilateral, and sometimes associated with neuropathic~     pain suggestive of obturator nerve irritation.~      There is no official recommendation or expert consensus on the management of pubalgia.~     However, a few protocols recommend a period of rest with Non-Inflammatory Anti-Steroidien~     Drugs (NSAIDs), icing and massages, as well as rehabilitation with passive stretching and~     muscle reinforcement.~      The use of botulinum toxin type A could be an option in cases of treatment failure. However,~     a feasibility study must be performed beforehand, and if results are positive, a controlled~     study on a larger cohort could be conducted.~      The major potential impact is a great effective pain relief for patients with neurological~     diseases.~   "
5365|NCT03496636|"~     Chemotherapy and radiation for cancer and other conditions can cause infertility. Several~     centers around the world are cryopreserving ovarian tissue from these patients though an~     experimental protocol, including the Fertility Preservation Program in Pittsburgh (protocol~     PRO08050491). The objective of this study is to study the efficacy and safety of autologous~     tissue transplantation in patients diagnosed with primary ovarian insufficiency after~     chemotherapy and/or radiation treatments.~   "
5366|NCT03496623|"~     This is a multicenter, randomized, double-blind, placebo-controlled, 30-week, adaptive~     cross-over study, with a Treatment Period of approximately 26 weeks under the Original Design~     or, if applicable, a 17-week parallel study, with a Treatment Period of approximately 14~     weeks under the Contingent Design.~   "
5367|NCT03496610|"~     The purpose of this study is to learn if using a Quadratus Lumborum (QL) plane injection~     technique (also called a nerve block) that numbs the nerves going to the abdominal area~     improve pain control after surgery compared to administration of local anesthetic directly to~     the surgical incision. The QL block technique uses a numbing solution (local anesthetics)~     that is injected next to nerves located along muscles in the back to reduce pain. This block~     will not affect movement in the leg and/or make the legs weak. Some institutions, including~     Duke, use the QL block for patients having various abdominal surgeries, with the hope of~     providing good pain relief combined with improved mobility after surgery.~   "
5368|NCT03496597|"~     The improvement of imaging techniques in ophthalmology has made it possible to carry out a~     precise non-invasive study of the retinal microvascular network and to detect early~     abnormalities in retinal disorders. The presence of such early retinal abnormalities remains~     poorly known during type 1 diabetes and may be detected with OCT-angiography. Furthermore,~     the association with glycemic variability, likely to have deleterious effects on~     microvessels, has never been studied.~   "
5369|NCT03496584|"~     This study will determine the effects of beneficial compounds of plant foods, such as~     pomegranate on cardiovascular health, skin inflammation and aging. This will be tested by~     asking healthy males to eat a high fat ground beef patty with 8oz. pomegranate juice or 8oz~     placebo (a study product that looks like pomegranate juice, but contains no active~     ingredients) and then measuring blood vessel dilation (endothelial function) by blood flow.~     The investigators also will measure the amount of Nitric Oxide (NO) in blood and urine~     samples and sugar and insulin in blood. In addition, a Cutometer, a device that measures the~     elasticity of the skin, will be used to obtain measurements of skin inflammation and aging.~      Healthy men have been chosen for this study because eating high fat hamburger patties can~     easily mimic in them the condition that causes atherosclerosis. The results from this study~     may help to explain how high fat foods can be harmful to the body and how beneficial plant~     foods can have on cardiovascular function and the skin.~   "
5370|NCT03496571|"~     This is a Phase 2, double-blind, randomized, placebo-controlled study to assess the effects~     of AK002, given monthly for 4 doses. It is hypothesized that AK002 is more effective than~     placebo control (alternative hypothesis) in reducing the number of eosinophils per high power~     field (HPF) in gastric and duodenal biopsies before and after receiving AK002 or placebo~     versus no difference between AK002 and placebo control (null hypothesis).~   "
5371|NCT03496558|"~     The project that is presented to the ethical committee, from the initial program called~     BECOME (Behavior of biomarkers (lipid profile and prolactin) during pregnancy and lactation~     through a biological multi-paradigm model), which already requested and obtained the~     Suitability dated April 28, 2015. Based on it, the development of the current project will be~     the historical memory of FPU Research Fellow (October 2016) The determination of the lipid~     profile in pregnancy is performed through blood tests in each of the quarters.~      A prospective cohort study will be conducted in women during pregnancy and lactation. From~     the first pregnancy visit until the child is six months old. Three prospectives (three annual~     series).~      At least 60 healthy pregnant women and 60 women with a history of risk (20 for each risk) x 2~     series (three years) will be tested, a total of 240-300 women to whom 5 analytical tests~     would have to be performed.~      The researchers will take samples from the breastfeeding workshop of the study groups: Group~     1 of healthy women and Group 2 of women with a history of risk (diabetes, overweight /~     obesity and hypertension)~   "
5372|NCT03496545|"~     The purpose of this study is to evaluate the antipyretic effect of bromocriptine in~     critically-ill patients with acute neurologic injury and fever from infectious and~     non-infectious etiologies.~   "
5373|NCT03496532|"~     Deep brain stimulation of the subthalamic nucleus is an effective treatment for Parkinson's~     disease. The analysis of cerebral signals of the subthalamic nucleus by local field~     potentials, provides one of the main electrophysiological markers of the success of the~     stimulation. This marker can be used to evaluate new paradigms of stimulation. So far, little~     studied, the temporal characteristics of the stimulation are very important in the~     effectiveness of the stimulation of the subthalamic nucleus, in Parkinson's disease. The~     first objective (Study I) is to compare the effectiveness of the stimulation when it is~     applied with biphasic symmetrical pulses and when applied with the standard pulses applied so~     far.~      The second objective (Study II) is to see if, by applying pseudo-random time intervals~     between each stimulation pulse, if it would be possible to improve the efficiency and to~     limit the side effects of the stimulation.~      The third objective (Study III) is to evaluate the electrophysiological changes of the~     subthalamic nucleus caused by the general anesthesia, in the anticipation of the realization~     of the surgery of the stimulation of the subthalamic nucleus under general anesthesia.~   "
5374|NCT03496519|"~     A phase 1 study examining the combination of Durvalumab (MEDI4736) and Trabectedin in various~     solid tumor types. The study seeks to determine a safe dose of the combination of study drugs~     and then examine this dose in larger groups of patients of specific tumor types to evaluate~     its anti-tumor efficacy. Treatment will continue in patients who respond for up to 1 year.~   "
5375|NCT03496506|"~     The purpose of this study is to evaluate the effect of clopidogrel on the pharmacokinetics of~     selexipag and its active metabolite (ACT-333679) in healthy male adults (by determining the~     blood concentrations of selexipag and its metabolite). Also, the safety of selexipag when~     administered alone or with clopidogrel will be assessed.~   "
5376|NCT03496493|"~     Perioperative non-invasive measurement of a patient's peripheral arterial oxygen saturation~     has become an accepted standard of care endorsed by anaesthesiologists and their regulatory~     bodies throughout the world. Pulse oximeters are an integral item on the World Health~     Organisation's Surgical Safety Checklist which is performed prior to the commencement of~     every surgical procedure. They are also utilised by other medical professionals and patients~     in various scenarios. When compared to conventional bedside pulse oximeters, portable~     fingertip devices have the advantages of cost-effectiveness, high portability, ease of use~     and battery operation. A review of recent literature reveals a paucity of accuracy studies in~     adult patients with various comorbidities in the clinical setting. Most data has been~     obtained under ideal laboratory conditions utilizing healthy adult volunteers. This study~     aims to pragmatically investigate the performance of a portable fingertip pulse oximeter in~     adult patients in a hospital setting.~   "
5377|NCT03496480|"~     The primary aim of this retrospective cohort study is to test the hypothesis that previous~     traumatization (long) before an ischemic stroke increases the degree of stroke-induced PTSD~     symptoms at 9-13 months after the stroke event. Secondary outcome parameters include quality~     of life and depression.~   "
5378|NCT03496467|"~     This is a Phase 2, multi-center, randomized, parallel-arm, double-masked, placebo-controlled~     study. One (1) to 2 days prior to their scheduled cataract surgery, each study subject will~     be randomized (2:1) in to one of two treatment groups: N-PPDS or p-PPDS, which are inserted~     in the lower punctum of the subject's scheduled surgical eye. All plugs will remain in the~     study subject's lower punctum for a period of 2 weeks following cataract surgery.~   "
5379|NCT03496454|"~     Controlled human malaria infection (CHMI) is an important tool for the assessment of the~     efficacy of novel malaria vaccines and drugs prior to field trials. CHMI also allows for the~     evaluation of immunity to malaria and parasite growth rates in vivo and thus allows for the~     assessment of the natural acquisition and loss of malaria immunity. This may be particularly~     useful in individuals from endemic areas with changing levels of exposure and immunity to~     malaria. Thus, CHMI in individuals with prior exposure to malaria could be a valuable tool to~     accelerate malaria vaccine development and inform malaria control programs of changing~     immunity levels and related disease presentations. In this trial, the investigators intend to~     study the effect of pre-exposure to Plasmodium falciparum (Pf) on parasite kinetics, clinical~     symptoms and immunity after CHMI by PfSPZ Challenge in Gambian adults. Based on a~     well-defined sero-profile representing the extremes of current malaria exposure in The~     Gambia, two cohorts will be identified to study the impact of naturally acquired immunity on~     susceptibility for a Controlled Human Malaria Infection.~   "
5398|NCT03496207|"~     Study A011-09 is designed to assesses the efficacy and safety of sotatercept (ACE-011)~     relative to placebo in adults with pulmonary arterial hypertension (PAH). Eligible~     participants will receive study treatment for 6 months in the double-blind Treatment Period,~     and then will be eligible to enroll into an 18-month Extension Period during which all~     participants will receive sotatercept. All treated patients will be also undergo follow-up~     period after last treatment.~   "
5636|NCT03493100|"~     The aim of this study is to evaluate long-term effects of early and prolonged individualized~     and optimized nutritional support using ONS for four weeks, in combination with a defined~     physiotherapy regimen, on sarcopenia and other outcome parameters in elderly fracture~     patients.~   "
5380|NCT03496441|"~     The study is based on the hypothesis that patients with postoperative anastomotic leakage~     have a different bacterial profile contributing to poor tissue healing, and that patients~     operated for colon cancer presumably have a different preoperative microbiota than healthy~     patients. This different composition is probably induced by the high heme level in the light~     intestinal tract that tumor spoliation generates.~      The objective of the study is to evaluate the feasibility of a larger study to evaluate the~     difference between microbiota composition of patients with and without colorectal cancer,~     with inflammatory bowel disease and those with and without anastomotic leakage~     postoperatively of a colonic resection.~      Stool samples will be taken from 20 patients, including 5 without intestinal pathology, 5~     with colorectal cancer undergoing colorectal surgery, 5 with inflammatory bowel disease and 5~     with anastomotic leakage after colectomy for colorectal cancer or inflammatory bowel disease.~      The stool samples will be analyzed at CRCHUM to draw up a profile of the bacteria that make~     up the microbiota of each patient.~   "
5381|NCT03496428|"~     Six patients with a single unit implant in the anterior maxilla (from premolar to premolar),~     after at least 3 months with provisional implant supported restoration will be submitted to~     definitive implant impressions.~      Informed consents and local ethical committee clearance will be obtained. Patients will be~     submitted to a silicon impression with a customized impression coping from which a~     conventional cast will be obtained and scanned with D2000 (3Shape) and to an intraoral scan~     with Trios (3Shape). Standard Tessellation Language (STL) files will be obtained from both~     procedures and imported to reverse engineering software Geomagic Control X (3D Systems) and~     the distance between both scans will be calculated in a colored 3D map. From this map, two~     outcomes will be analyzed: the changes in soft tissues around implants with the two~     techniques (primary outcome) and the discrepancy between both scans in the teeth adjacent to~     the implants (secondary outcome).~   "
5382|NCT03496415|"~     The overall incidence of DWI positive for thromboembolic events following endovascular~     treatment of intracranial aneurysms is proximately 50%. Whether remote ischemic conditioning~     was safe and effective to reduce ischemic brain lesions on DWI after endovascular treatment~     of intracranial aneurysms is still unclear. The investigators' hypothesis is that remote~     ischemic conditioning is a safe and effective strategy to reduce new ischemic lesions in~     intracranial aneurysms patients undergoing endovascular treatment.~   "
5383|NCT03496402|"~     Methodology:~      Prospective, multicentric, open, non-randomised, non-therapeutic, interventional study~   "
5384|NCT03496389|"~     Anterior cruciate ligament (ACL) injury is a common sport injury in both professional and~     recreational athletes. Furthermore, persistent quadriceps weakness and wasting are frequently~     observed after anterior cruciate ligament reconstruction (ACLR). Several studies have~     demonstrated that muscular rehabilitation to normal strength is difficult, protracted, and~     often not achieved due to the inability to fully activate the quadriceps voluntarily. Pain~     and disuse are often blamed for the inhibition of muscle activation following joint injury.~     However, arthrogenic muscle inhibition (AMI) is often overlooked and not addressed. Thus, the~     magnitude of strength restoration of the quadriceps is frequently restricted despite solid~     rehabilitation protocols. As AMI is a reflex inhibition of musculature involving the~     neurotransmitter γ-aminobutyrate (GABA), Gabapentin may have a potential role in modulating~     AMI, therefore limiting muscle weakness after ACLR.~   "
5385|NCT03496376|"~     The purpose of this study was to investigate the effect of kinseio taping on functional~     capacity, pulmonary functions, respiratory muscle strength, severity of dyspnea, severity of~     fatigue in Chronic Obstructive Pulmonary Disease (COPD). Assessment of patients was done~     baseline and 6th week.~      Eligible patients for the study randomly allocated to Kinesio Taping Group (KTG), or Control~     Group (CG). Both groups received three different deep breathing exercises (diaphragmatic,~     thoracic, and lateral basal), each consisting of three sets of 10 repetitions, with 30~     seconds of rest between each set. KTG also received thoracic kinesio taping application.~   "
5386|NCT03496363|"~     Congenital hypothyroidism is one of the most preventable causes of neurocognitive impairment~     because early treatment is possible in neonates. The thyroid hormone is important for normal~     growth and development in infancy. After introducing national screening test using capillary~     thyroid stimulating hormone level, the incidence of untreated congenital hypothyroidism has~     significantly decreased.~      According to the Italian Registry of Congenital Hypothyroidism, congenital heart disease is~     the most frequent disease condition associated with congenital hypothyroidism.~      Congenital heart disease is also reported to be a risk factor for non-autoimmune~     hypothyroidism in children. In addition, intravenous iodine contrast media is frequently used~     for diagnostic imaging and therapeutic intervention in congenital heart disease patients.~     Excess iodine exposed by iodine contrast media may disturb thyroid function in adult and~     pediatric population. However, there is no generally accepted guideline for screening thyroid~     dysfunction in congenital heart disease infants.~      An increased prevalence of thyroid disease, particularly sub-clinical hypothyroidism, has~     been reported in Down Syndrome. In children with Down Syndrome, a possible concomitant~     sub-clinical hypothyroidism-related impairment of cardiac function or structure may worsen~     their clinical condition and can ultimately affect their life expectancy.~   "
5387|NCT03496350|"~     The purpose of this study is to evaluate the efficacy of a culturally adapted~     internet-administrated cognitive behaviour therapy (ICBT) in Arabic for anxiety and~     depression~   "
5399|NCT03496194|"~     This study aims to investigate the current organization and management of postoperative pain~     in Denmark, especially for invasive pain treatment modalities (epidural infusions, PCA and~     regional blocks), in a national survey covering the activities in Danish Hospitals.~      This study is an electronic questionnaire survey, that aim to describe and map the foundation~     for future developments within, and improvement of, postoperative pain management.~   "
5421|NCT03495895|"~     Minding the Baby is an intensive and preventive home-visiting programme that helps vulnerable~     or high risk mothers. MTB is delivered by an interdisciplinary team. Ten Danish sites will be~     randomized to training at time 1 or 2 and recruit usual care control families before they~     receive the training. Families are assessed before they give birth and when their child is~     three months, one and two years old with a range of assessments including maternal~     sensitivity, parent mental Health, child development, and health related register data. The~     aim of the trial is to assess the effectiveness of Minding the Baby to improve mother-child~     relations and the mental health of parents and children.~   "
5388|NCT03496337|"~     The aim of the study is to assess the responsiveness of the Assessment of Motor and Process~     Skills (AMPS) in a population of patients undergoing rehabilitation following hand surgery,~     as this has not previously been investigated.~      Methods: Patients are included from the department of physical and occupational therapy at~     Silkeborg Regional Hospital in the period November 2017 to May 2018. A total of 50 patients,~     who have been referred for specialized occupational therapy rehabilitation following finger~     or hand surgery, will be included. At baseline and follow-up (after 8 weeks) all patients are~     assessed with AMPS, Canadian Occupational Performance Measure (COPM), hand grip strength and~     joint range of motion using standardized methods. Responsiveness to change is evaluated using~     an anchor-based method, comparing AMPS scores with the scores on the Global Rating Scale. The~     area under the ROC curve will be calculated, and an area under the curve of 0.7 is considered~     acceptable. Convergent and discriminative validity of the AMPS will be assessed across the~     different instruments used. Thus the investigators expect a higher correlation between AMPS~     and COPM and lower correlation between AMPS and hand grip strength and range of motion.~   "
5389|NCT03496324|"~     Bioequivalence evaluation of Nurofen for Children® with reference formulation of Algifor®~     Junior by determining and comparing the rate and extent of absorption in both fed and fasted~     states~   "
5390|NCT03496311|"~     The third trimester of pregnancy is typically characterized by the development of a marked~     respiratory alkalosis. The possible role of pregnancy-induced variations of cerebrospinal~     fluid (CSF) acid-base characteristics on the development of hypocapnic alkalosis is still~     unknown.~      Aim of this study is to characterize, according to Stewart's approach, the acid-base~     equilibrium of CSF and arterial plasma of pregnant women and compare the results with data~     obtained from fertile, non-pregnant women.~   "
5391|NCT03496298|"~     Primary Objective:~      -To demonstrate that, efpeglenatide doses 1 and 2 is noninferior to placebo on 3-point major~     adverse cardiac event (MACE) in Type 2 diabetes mellitus (T2DM) patients at high~     cardiovascular (CV) risk.~      Secondary Objectives:~        -  To demonstrate that efpeglenatide doses 1 and 2 is superior to placebo in T2DM patients~          with high CV risk on the following parameters:~        -  3-point MACE.~        -  Expanded CV outcome.~        -  Composite outcome of new or worsening nephropathy.~        -  To assess the safety and tolerability of efpeglenatide doses 1 and 2, both added to~          standard of care in T2DM patients at high CV risk.~   "
5392|NCT03496285|"~     Restrictive anorexia nervosa and TOCs are psychiatric diseases which shares a common~     pathophysiological substrate We hypothesize that anorexia patients and patients with OCD have~     structural and functional changes in the accumbofrontal tract. The main objective of this~     study will be to compare the structure and the connectivity of this tract in MRI with~     diffusion sequences (DTI tractography) and resting-state, in 3 distinct populations of~     anorexic patients, patients with OCD and healthy patients. The role of the accumbo-frontal~     tract in the cortico-striato-hypothalamo-cortical circuit seems to be established. DTI~     tractography will allow the measurement of functional anisotropy (FA), a parameter that~     evaluates the diffusion of water molecules along the white matter fibers, and therefore the~     potential alteration of the studied tract. Resting state sequences will allow to estimate the~     BOLD signal and the functionality of the tract.~   "
5393|NCT03496272|"~     Background: The atrial fibrillation cycle length (AFCL) measured by electrophysiologic study~     is well known parameter for the maintenance of sinus rhythm after DC cardioversion (DCCV) or~     ablation therapy. The aim of this study was to test whether a AFCL measured by~     transesophageal echocardiography (AFCLTEE) could predict the outcome after DCCV.~      Methods: In 100 consecutive patients with non-valvular AF, TEE will be performed within 6~     hours before DCCV. The AFCLTEE was measured by averaging 10 sequential peak to peak intervals~     of atrial fibrillary waves seen in the pulsed wave Doppler image on the left atrial~     appendage. The primary endpoint was AF free survival rate at 6 months after DCCV.~   "
5394|NCT03496259|"~     Open abdominal and pelvic surgery or thoracotomy (open chest surgery) is frequently performed~     for tumor excision in children. Post-operative pain management regimens are often at the~     discretions of the attending surgeon and may include opiods, patient administered analgesia~     (PCA), epidural catheters, subcutaneous analgesia catheters or NSAIDS to control incisional~     pain. Currently, both epidural or subcutaneous analgesia catheters (On-Q pumps) are commonly~     used for children undergoing these operations, at the discretion of the surgeon. There are no~     studies comparing these regimens in children. The purpose of this study is to compare~     postoperative pain control of the two strategies.~   "
5395|NCT03496246|"~     Inflammatory bowel disease (IBD), comprising crohn's disease (CD) and ulcerative colitis~     (UC), is a a chronic, relapsing-remitting systemic disease. Vitamin D is a secosteroid~     hormone that possesses immunomodulatory properties and has been demonstrated to potentially~     influence inflammatory bowel disease (IBD) pathogenesis and activity.~   "
5396|NCT03496233|"~     Antiviral treatment of G1b Treatment-Naïve HCV-Infected Patients, with non- severe fibrosis,~     with or without insulin resistance (IR) and/or diabetes mellitus (DM) with EBR/GZR Fixed-Dose~     Combination for 8 Weeks.~   "
5397|NCT03496220|"~     Ventilator-associated events (VAE) are a scourge of critical care settings and hospital~     systems at large. There is extensive evidence that ventilator-associated pneumonia (VAP) and~     related VAEs increase mortality rates in critically ill patients by up to 50%, while~     simultaneously increasing cost of care. C~      Best-practice guidelines state that positioning ventilated patients at an angle between 30-45~     degrees significantly reduces the potential for VAP and other VAE to develop. While the~     intent of the guidelines is to govern patient elevation angle, the lack of a mechanism to~     accurately measure patient elevation requires that nurses rely on the head-of-bed (HOB)~     protractor - a tool which reflects the angle of the bed, not the patient - to measure~     compliance. Depending upon the position and posture of the patient in the bed, a patient's~     elevation angle may be significantly different from the HOB angle. Critical care teams~     currently rely on built-in HOB protractors and digital inclinometers that measure the angle~     of the bed not the patient.~      Angulus, LLC has developed a dual-component Angulus sensor to fill this gap in critical care~     technology. Angulus enables critical care practitioners to instantaneously understand a~     patient's elevation, identify when the patient is outside of the desired 30-45 degree~     recumbency scope, and efficiently correct the patient's orientation with immediate feedback.~     Angulus supports real-time minute-to-minute data display as well as longitudinal aggregation~     of data.~   "
5400|NCT03496181|"~     Functional magnetic resonance imaging (fMRI) is a non-invasive test used to detect changes in~     brain activity by taking picture of changes in blood flow. The imaging helps doctors better~     understand how the brain works. Task based fMRI (TB fMRI) prompts patients to perform~     different activities (e.g. word selection in a reading task), and is routinely performed on~     patients in preparation for a Neurological surgery (surgery that involves the nervous system,~     brain and/or spinal cord). The purpose is to locate areas of the brain that control speech~     and movement; these images will help make decisions about patient surgeries. However, there~     are however gaps in knowledge specific to the language areas of the brain, especially for~     non-English patients and bilingual patients (those who are fluent in more than one language).~     This study proposes to evaluate if resting state fMRI (RS fMRI) that does not require any~     tasks, along with a novel way to analyze these images using graphy theory, may provide more~     information. Graph theory is a new mathematical method to analyze the fMRI data. The overall~     goal is to determine if graph theory analysis on RS fMRI may reduce differences in health~     care treatment and outcomes for non-English speaking and bilingual patients. We hope that the~     results of this study will allow doctors to perform pre-operative fMRI in patients who do not~     speak English.~   "
5401|NCT03496168|"~     This is a multicenter open-label study of the administration of mavacamten in participants~     with symptomatic obstructive HCM (oHCM) who previously participated in study MYK-461-004~     (PIONEER-HCM).~   "
5402|NCT03496155|"~     The purpose of this study is to test a strengths-based intervention to be delivered in a~     primary care setting with adolescents and a parent. Investigators want to find out if the~     intervention can help parents and teens communicate. Specifically Investigators want to see~     if they can help parents and teens identify and build teen's strengths. Half the dyads will~     receive the educational materials in conjunction with their teen's well-child visit, while~     the other half will receive usual care at the well-child visit and receive the educational~     materials at the end of the study. Additionally, Investigators expect that a strengths-based~     intervention may also impact adherence to treatment in youth with a chronic illness. As such,~     Investigators will include a subgroup of teenagers diagnosed with asthma in this study, to~     assess whether the strengths-based intervention that the Investigators developed has an~     impact on adherence.~   "
5403|NCT03496142|"~     Retrospective reports from literature have shown a lower rate of infections for transperineal~     versus transrectal approach for prostate biopsies in the setting of prostate cancer~     suspicion.~      The aim of this study would be to compare in a prospective randomized trial the rate of~     infection with transperineal versus transrectal approach.~   "
5404|NCT03496129|"~     Substance-Impaired Driving among college students remains a significant public health concern~     and may be the single riskiest substance-related outcome among young adults. Brief~     Interventions (BIs) have been shown to reduce alcohol-impaired driving among college~     students, but are not often implemented - despite their demonstrated efficacy - because it is~     not economically feasible for universities to hire and train staff to deliver in-person BIs~     to all college substance users. Very few college students seek out substance prevention or~     treatment services available on campus or in the surrounding community. Innovative ways of~     delivering BIs to this at-risk population in a manner that is both effective and economically~     feasible have to be developed. The present study will be the first to examine whether a~     text-messaging-based substance-impaired driving BI significantly decreases substance-impaired~     driving among colleges substance users compared to an informational control. Participants~     will be 150 college students who endorse driving after substance use (alcohol, drugs, and/or~     combined alcohol/drugs) at least twice in the past 3 months. After completing baseline~     measures, participants will be randomly assigned to receive either: a) substance use~     information, b) a substance-impaired driving personalized feedback intervention, or c) a~     substance-impaired driving personalized feedback intervention plus interactive text messages.~     Participants will complete outcome measures 3, 6, and 12 months post-intervention. Repeated~     measures mixed modeling analyses will be used to determine whether the intervention~     significantly reduces substance-impaired driving over time. The project has two specific~     aims: 1) to evaluate a text based substance-impaired driving intervention in a randomized~     clinical trial, and 2) to determine whether the use of interactive text-messages sustains~     intervention effects over time. This study is innovative because it utilizes cutting-edge~     technology to deliver the entire intervention, enabling the study to reach a large number of~     students in a short time period at a low cost. The study is significant because it will~     contribute substantially to the substance-impaired driving literature by identifying an~     intervention that can decrease substance-impaired driving among this high-risk population.~     Additionally, this study will add to the newly emerging technology-based intervention~     literature.~   "
5405|NCT03496116|"~     The purpose of this study is to measure the individual and combined influence of electronic~     cigarette (ECIG) heating element resistance and liquid nicotine concentration on ECIG acute~     effects. Thirty-two experienced ECIG users will complete four independent laboratory sessions~     that will differ by heater resistance (0.5 ohm or 1.5 ohm) and liquid nicotine concentration~     (3 or 8 mg/ml). Other factors such as voltage, liquid solvent ratio, and liquid flavor will~     be held constant. Plasma nicotine concentration, subjective effects, and puffing behavior~     will be recorded for each condition.~   "
5406|NCT03496103|"~     In this study subjects self recorded nasal and ocular symptoms scores from exposure to~     ragweed pollen in an Allergen Challenge Chamber (ACC). This single site study of seasonal~     allergic rhinitis was designed to enroll up to 35 participants. These participants would be~     age 18-70, male and female, with a mixture of ethnic groups. The study would involve 2~     phases: Screening and Exposure. In the Exposure phase, participants were exposed to pollen~     for up to 180 minutes.~   "
5407|NCT03496090|"~     Phase III trial is designed to demonstrate the non-inferiority of a free diet versus a~     progressive diet in the treatment of acute diverticulitis (AD) without complications. In this~     study, the effectiveness of the short-term free diet is evaluated, as well as its safety and~     the quality of life that is perceived in front of the progressive diet.~   "
5408|NCT03496077|"~     This study is about whether or not little cigars and cigarillos cause or maintain addiction,~     and if flavors, such as fruit, make them more addictive. The purpose of this study is to~     understand the addiction potential of little cigars and cigarillos compared to cigarettes in~     young adults who smoke both products. This study will also look at the differences between~     men and women. In the rest of this form, little cigars or cigarillos will be referred to as~     LCCs.~   "
5409|NCT03496064|"~     The Bernese-European RegistrY for ischemic stroke patients treated Outside current guidelines~     with Neurothrombectomy Devices using the SOLITAIRE™ FR With the Intention For Thrombectomy~     (BEYOND-SWIFT) is a retrospective, multi-center, non-randomized observational study aims to~     investigate the safety and efficacy of a Medtronic market-released neurothrombectomy device~     (applied as initial devices used for intervention) in acute ischemic stroke patients who do~     not fulfill treatment eligibility according to current guidelines. Patients will be treated~     or were treated at the discretion of the investigator, independent of participation in this~     registry. Primary Analysis is the Impact of successful reperfusion on functional outcome at~     day 90 in patients presenting with large infarct cores (ASPECTS<6) or minor symptoms~     (NIHSS<8).~   "
5411|NCT03496025|"~     Purpose of the trial is to study the activations of paralyzed facial muscles in a unilateral~     facial nerve palsy with a multi-channel electrical stimulator. The principle of the device is~     to measure muscle activity of the healthy side of the face by surface electromyography (EMG)~     and to use this information to stimulate the corresponding muscles of the paralyzed side. The~     ultimate goal is to develop a prosthetic device for persons with a facial nerve palsy.~      The trial consists of several different studies. The studies' aims are 1. To study~     activations of paralyzed facial muscles by the electrical stimulation. 2. To study different~     stimulation pulse waveforms, frequencies, and electrode placement and their effect on the~     muscle activations and the tolerability of the stimulation. 3. To study whether a symmetrical~     movement on the paralyzed side can be achieved with electrical stimulation when compared to~     the movements of the healthy side. 4. To study tolerability of stimulation-elicited eye blink~     when watching a film and the effect of the stimulation-induced blink on the eye symptoms, the~     visual acuity, and the effects of the stimulation on the lacrimal fluid. 5. To develop a~     method for facial pacing, i.e. measuring the muscle activations on the healthy side of the~     face and to use this information to stimulate and activate the healthy side of the face.~      Forty subjects with a chronic facial nerve palsy are recruited to the studies. Each subject~     can participate in one or several studies. Another forty subjects with an acute facial nerve~     palsy are recruited to the study on the tolerability and effect on the eye symptoms.~     Additionally, altogether ninety healthy volunteers are recruited to the studies in order to~     gather preliminary information on the tolerability and the effects of the stimulations.~   "
5412|NCT03496012|"~     The objective of the study is to evaluate the efficacy and safety of a single sub-retinal~     injection of AAV2-REP1 in subjects with Choroideremia.~   "
5413|NCT03495999|"~     Metabolic syndrome and hyperuricemia were both associated with inflammation, leading to~     diversities of cardiovascular disease such as left ventricular diastolic dysfunction, but the~     relationship among these entities remained unclear. The aim of the present study focuses on~     the association among hyperuricemia, diastolic dysfunction and inflammatory biomarkers in~     apparently healthy individuals with metabolic syndrome~   "
5414|NCT03495986|"~     Evaluate and compare the health benefits of an at home exercise program using functional~     electrical stimulation (FES) for lower extremity exercise with diet versus a diet alone group~     in adults with spinal cord injury.~   "
5415|NCT03495973|"~     The main purpose of this study is to assess ustekinumab's ability to induce clinical response~     and remission (effectiveness) at Week 16 and remission at Week 52 and Week 104 in~     participants with Crohn's disease (CD). Response and remission will be assessed using~     clinical parameters. Retention rate at week 52 and 104 will also be studied.~   "
5416|NCT03495960|"~     Primary central nervous system lymphomas are rare aggressive malignancies, usually treated in~     two steps: an induction phase (where a combination of chemotherapy is given) followed by a~     consolidation phase (where patients usually receive one of the following: whole-brain~     irradiation, chemotherapy supported by autologous stem-cell transplantation, other type of~     chemotherapy, or are just observed).~      The feasibility of this overall strategy, for several reasons, is limited in elderly patients~     .~      This study involves patients aged ≥70 years. The more fit patients will receive the standard~     chemotherapy combination (high-dose methotrexate, procarbazine and rituximab) as induction.~     Responding patients will receive either procarbazine or lenalidomide as maintenance therapy;~     the aim is to evaluate the efficacy of these two drugs.~      The more fragile patients will receive a less aggressive therapy consisting of concomitant~     whole-brain radiotherapy, temozolomide and rituximab as induction therapy, followed by~     temozolomide as maintenance treatment; the aim is to evaluate the efficacy of this~     combination of treatment.~   "
5417|NCT03495947|"~     The aim of the study is to determine the incidence of failure of extubation in high-risk~     patients using High Flow Nasal Cannula (HFNC) to prevent such failure in the Intensive Care~     Unit. A prospective cohort study was performed. To all adult patients receiving invasive~     mechanical ventilation ≥ 48 hours and ready for scheduled extubation according to tolerance~     of spontaneous breathing trial, with at least one of the criteria for high-risk for~     extubation failure (age greater than 65 years, hypoxemic acute respiratory failure as a cause~     of invasive mechanical ventilation, > 1 spontaneous ventilation test failed consecutive,~     history of chronic heart failure, history of chronic obstructive pulmonary disease or PaCO2>~     45 mmHg, body mass index >30 kg/m2, post-operative solid organ transplantation), HFNC is~     applied for 24 hours. Demographic variables and clinical and gasometric parameters at the end~     of the spontaneous breathing trial, at 60 minutes, at 6 and 24 hours after the start of HFNC~     are recorded.~   "
5418|NCT03495934|"~     The current study is designed to generate data for the investigation of absorption,~     distribution, metabolism and elimination (ADME) processes of pracinostat in humans, as well~     as generating samples for metabolite profiling and structural identification. The mass~     balance recovery of pracinostat following administration of [14C]-pracinostat will be~     assessed, as well as metabolite profiling and identification of pracinostat in healthy male~     subjects. In addition, this study will provide further PK and safety data in healthy~     subjects.~   "
5419|NCT03495921|"~     This is a two-part, multicenter, 1:1 randomized Phase III study of intradermal autologous~     Vigil immunotherapy (1.0 x 10e6 cells/injection cells/injection; minimum of 4 to a maximum of~     12 administrations) in combination with irinotecan and temozolomide in subjects with~     metastatic Ewing's sarcoma Family of Tumors (ESFT) refractory or intolerant to 1 prior line~     of chemotherapy. Participants undergoing a standard surgical procedure (e.g., tumor biopsy or~     palliative resection) may have tumor tissue harvested for manufacture of investigational~     product.~   "
5420|NCT03495908|"~     The purpose of the study is to collect data about how well U-100 Regular Human Insulin can be~     used in the V-Go Insulin Delivery Device compared to U-100 Rapid Acting Insulin in the V-Go~     Insulin Delivery Device. The data collected will be used to see how much subjects' blood~     sugar levels change over time after they switch from using U-100 Rapid Acting Insulin to~     U-100 Regular Human Insulin within their V-Go Insulin Delivery Device.~   "
5422|NCT03495882|"~     This is a Phase 1/2, open-label, multi-arm study, of AGEN1884 in combination with AGEN2034 in~     subjects with advanced solid tumors including cervical cancer.~   "
5652|NCT03492892|"~     To assess the effect of acupuncture versus sham acupuncture on regulating the targeted~     metabolome of hypertensive patients.~   "
5423|NCT03495869|"~     The overall goal of this project is to collect preliminary data on psychosocial measures and~     behavioral performance comparing individuals with Opioid Use Disorder, Cocaine Use Disorder,~     dual diagnosis of Opioid and Cocaine Use Disorder, and Healthy Controls in an effort to~     determine overall feasibility of a phenotypic fingerprint for cohorts of individuals with~     addictions for use during clinical trials.~   "
5424|NCT03495856|"~     The objective of this study is to determine the feasibility and acceptability of a 4-week~     mindfulness training program for adults with chronic pain (noncancer related). The~     intervention is based on the MIndfulness-based Stress Reduction Program, an 8-week~     mindfulness training program developed to help people manage stress-related and chronic~     conditions. The adapted mindfulness intervention will consist of four, weekly 1 hour and 30~     minute group sessions that are modified from the original program to fit the shorter length~     and to directly address chronic pain management. Participants will complete pre- and~     post-intervention surveys and daily mindfulness practice diaries, all online. The surveys~     will help us determine if participants experience decreased pain interference, increased~     quality-of-life, and increased psychological well-being over the course of the intervention.~     Participants will also complete a post-intervention telephone interview to help determine~     satisfaction with the intervention and areas where the intervention can be improved.~   "
5425|NCT03495843|"~     The objective of this study is to examine the influence of body position and additional axial~     load on spinal stiffness in young healthy adults.~   "
5426|NCT03495830|"~     Introduction: Taxinomisis trial is part of the Taxinomisis project. The concept of the~     Taxinomisis project is to stratify carotid artery disease relying on new modern data~     corresponding to contemporary patients based on information from longitudinal studies.~     Taxinomisis trial will validate this tool and adjust such stratification. Initial step of the~     project is characterization of symptomatic and asymptomatic carotid atherosclerotic plaque~     lesions, identification of risk and susceptibility factors through the exploitation of~     longitudinal cohort data and multiomics and disintegration of carotid artery disease~     phenotypes into endotypes through joint modeling of multipleomics data sets and systems~     medicine approaches. Finally such stratification model will be validated and adjusted in the~     Taxinomisis clinical trial.~   "
5427|NCT03495817|"~     Open label study to assess safety, tolerability, and efficacy of ATI-50002 in male and female~     subjects with androgenetic alopecia.~   "
5428|NCT03495804|"~     CT enterography has become an important tool in the evaluation of small bowel diseases,~     especially in patients with inflammatory bowel diseases. There are several shortcomings of~     commonly used isotonic mannitol as an oral contrast agent, such as incident adverse reactions~     and gases in the gut. However, polyethylene glycol can avoid these drawbacks with a good~     performance in some pilot experiments.~   "
5429|NCT03495791|"~     This study will provide an educational intervention through means of a video to educate~     subjects on the risk of cardiovascular health on Rheumatoid arthritis.~   "
5430|NCT03495778|"~     The objectives of this study are to examine the blood glucose and serum insulin response~     elicited by servings of Test Granola and Control Granola containing equal amounts of~     available carbohydrate over a 3 h time period. In addition, the subjective hunger response to~     these foods will be measured over 3 h.~   "
5431|NCT03495765|"~     To demonstrate the comparative effectiveness of 12 months of Lucentis (ranibizumab) in~     patients with well controlled compared to those with poorly controlled diabetes using an PRN~     treatment schedule.~   "
5432|NCT03495752|"~     This study investigates the effect that performing a cardiovascular maximum effort test (the~     Bruce treadmill protocol) has on performance of the Forward-Step-Down Test (FSDT). The FSDT~     is performed prior to the fatigue protocol as a baseline measurement, then at 1, 5, and 10~     minutes after the fatigue protocol. Participants much reach a certain heart rate (within 10~     bpm) of their age predicted maximum heart rate to ensure that the fatigue protocol reaches a~     maximum fatiguing effort.~   "
5433|NCT03495739|"~     A randomized, open-label, single-dosing, 2x2 crossover study, the safety and pharmacokinetics~     of RDG-17012 with Pradaxa® in healthy male volunteers~   "
5434|NCT03495726|"~     The general scope of the study involves meditation and its effects on pain management,~     narcotic use, and emotional well-being. Half of the participants will receive access to a~     meditation app, which they will be asked to use for at least 10 minutes every day for 6~     weeks, while the other participants will be in the waitlist group and will receive a~     subscription to the meditation app after the 6 week study period ends. All participants will~     be asked to complete a set of questionnaires~   "
5435|NCT03495713|"~     This is a Phase II single-arm, single-site, open label clinical trial with r/r HL patients,~     aimed to determine whether a RadVax approach using low-dose RT added to nivolumab can improve~     response among patients who do not achieve a CR to nivolumab alone. The long-term goal is to~     develop an effective regimen for r/r HL patients.~   "
5436|NCT03495700|"~     The L-PRF block is a combination of bone substitute with L-PRF. The use of a L-PRF block in~     bone augmentation therapies could enhance and improve bone regeneration.~      The primary objective of this study is to evaluate if the use of autologous leukocytes and~     platelet rich fibrin accelerate and promotes bone regeneration in the sinus in comparison~     with the standard sinus lift procedure procedure.~   "
5437|NCT03495687|"~     The aim of this study is to examine differences between respiratory function in female~     fibromyalgia patients and healthy controls. The study will also examine differences in spine~     mobility and pain intensity.~   "
5438|NCT03495674|"~     The goal of this research study is to learn if sustained exercise can affect the outcomes in~     patients with a specific type of colorectal cancer called Lynch Syndrome .~      This is an investigational study.~      Up to 20 participants will be enrolled in this study. All will take part at MD Anderson and~     in the local community.~   "
5489|NCT03495011|"~     This is a single institution, prospective observational clinical trial for women with~     mammographically detected suspicious calcifications who have been recommended breast biopsy.~      The purpose of this study is to determine whether quantitative, multiparametric breast MRI~     performed prior to biopsy can biologically characterize a common pre-invasive malignancy,~     ductal carcinoma in situ (DCIS), which typically presents in asymptomatic women as suspicious~     calcifications on mammography.~   "
5439|NCT03495661|"~     Lumbar spinal stenosis (LSS) is characterized by low back and leg pain, walking disturbances~     and sometimes instability, impaired balance and numbness of the lower limbs. This condition~     is caused by degenerative changes in the lumbar spine including bulging discs, osteophytes~     from the arthritic facet joints and thickened ligamentum flavum which together cause~     narrowing of the spinal canal and thus affect the lumbar nerve roots. This diagnosis is~     attracting more and more interest due to the aging population with increasing demands for~     physical activity. LSS is the most common indication for spinal surgery. The surgical~     treatment involves relieving the pressure from the nerve structures in the stenotic segments~     through a posterior approach. In several studies, surgery has been shown to have better~     results than the conservative treatment. However, methodological difficulties and a large~     proportion of cross-over in these studies indicate that there is still uncertainty about~     whether surgery is generally a better option.~      It has been speculated whether the compression of the nerve roots causes in some patients~     permanent nerve damage with muscle denervation, while in other cases a reinnervation and~     recovery of the function may occur. Results from neurography and EMG studies have been shown~     these modalities to have a possible predictive value for the natural process of LSS. If a~     neurophysiological examination could be able to predict which patients are able to benefit~     from surgery, many patients could avoid surgery and the risks involved in it.~      The aim of this study is primarily to evaluate whether surgery with decompression leads to~     superior results than the non-surgical treatment with structured physical therapy.~      The main secondary aim is to investigate by means of Neurography and EMG, whether the degree~     of neurological affection caused by nerve compression affects the outcome of surgery for LSS.~   "
5440|NCT03495648|"~     The Tanglewood Trail Walking Program is a well established community health initiative that~     encourages community members to walk approximately 1 mile to the Whitesburg Farmers Market~     each Saturday. The study aims to determine if walking to the market with a community health~     coach results in healthier options being selected at the market when compared to the driving~     group.~   "
5441|NCT03495635|"~     The purpose of this study is to evaluate the effectiveness of the Big Brothers Big Sisters of~     America (BBBSA) community-based mentoring (CBM) program for prevention of crime and~     delinquency/conduct problems, including risk and protective factors for these outcomes.~     Approximately 2,500 youth ages 10-16 will be randomly assigned to either the CBM program or~     an untreated control group. Study outcomes will be assessed over a 4-year period via both~     youth- and parent-report surveys and official records of police/court contact (e.g.,~     arrests).~   "
5442|NCT03495622|"~     The study is a multi-center 1-year community-based cluster randomized controlled trial to~     assess the role of a combined community health worker and mobile health intervention in~     controlling one of the most common cardiovascular risk factors, tobacco use. Participants~     will include 560 adults, 35-70 years of age, from the urban communities of Dalkhola, West~     Bengal, and Jabalpur, Madhya Pradesh, India. The hypothesis of the study is that this~     combined approach can result in increased quit rate among tobacco users.~   "
5443|NCT03495609|"~     Specific aim: To establish the proof of principle that treatment of high breast cancer risk~     women with recombinant human chorionic gonadotropin (r-hCG) will change their breast~     epithelium's high risk genomic profile to one similar to that identified in women with a~     history of early full first term pregnancy.~   "
5444|NCT03495596|"~     The primary goal of this study was to identify parameters affecting the failure of~     videolaryngoscopy in clinical practice; secondly, the incidence of videolaryngoscopy use and~     the most frequently used patient groups.~   "
5445|NCT03495583|"~     The EAT Study showed a reduction in both sensitisation (to all foods) and clinical food~     allergy (to peanut and egg) among children who consumed allergenic food early compared with~     those who followed standard government feeding advice to exclusively consume breast milk for~     the first 6 months of life. The EAT-On Study aims to establish whether the effects seen at 3~     years in the EAT study represent a delay in FA onset or sustained tolerance. EAT-On will also~     investigate the natural history (emergence and resolution) of FA in childhood; thus shaping~     dietary and management plans for allergic patients. Findings will inform future research and~     weaning recommendations for preventing FA.~   "
5446|NCT03495570|"~     The XN-20, is a full blood count (FBC) analyser with an extended differential counting and~     flagging System. The XN-Series' individual channels allow real-time reflex analysis, and uses~     a two stage process to classify the white blood count (WBC) sub-populations and detect the~     presence of abnormal reactive and malignant cells. In regards to lymphocytes in the~     peripheral blood, the machine has the capacity to distinguish activated from non-activated~     T-cell subsets using a very small volume of EDTA sample (88uL) (including remnant sample from~     a standard full blood count) with results available in 1.5 minutes. It is a fully automated~     process and can be considered as an alternative rapid flow cytometry method.~      Objective of the SASA study: to investigate the signal pattern of white blood cells assessed~     using the XN-20 full blood count platform in patients with untreated viral infections i.e.~     HIV, HCV and HBV. The data from the analysis will be reviewed in conjunction with patient's~     demographic and clinical disease characteristics with the aim of detecting characteristic~     cell populations that can be used in the development of system flags for future studies.~   "
5447|NCT03495557|"~     A prophylactic mesh fixation after fascial closure in umbilical trocar after cholecystectomy~     may prevent the trocar site hernia incidence. Especially in patients who present certain risk~     factors.~   "
5448|NCT03495544|"~     This is a multicentre, non-interventional, prospective study to be carried out in~     representative oncology departments / institutions in order to determine the association~     between the presence of germline DNA-repair genes mutations and PD-L1 expression level in~     tumour and immune cells in breast cancer. No additional procedures besides those already used~     in the routine clinical practice will be applied to the patients.~   "
5449|NCT03495531|"~     The purpose of this study is to determine if non-invasive distracting devices (Virtual~     Reality headset) are more effective than the standard of care (i.e., no technology based~     distraction) for preventing anxiety and pain scores in women who are undergoing child~     laboring procedures. The anticipated primary outcome will be a reduction of pregnant females~     overall anxiety and pain scores before and after such procedure(s), including but not limited~     to epidural/combined spinal epidural (CSE), IV placement and/or labor.~   "
5490|NCT03494998|"~     Increasing attendances by children (aged 0-16 years) at UK emergency departments (EDs) is~     putting pressure on the National Health Service (NHS). Health professionals make complex~     judgements on whether children attending EDs can be sent home safely or require admission.~     The Pennine Acute Hospitals (PAT) Paediatric Observation Priority Score (PAT-POPS) was~     developed as an ED-specific screening tool for this purpose. A preliminary study showed it to~     be a potentially effective tool for deciding admission of children from the ED. Therefore,~     the focus of this study is to refine the original screening tool.~   "
5450|NCT03495518|"~     Children with cancer and hematopoietic stem cell transplant (HSCT) recipients suffer from~     severe and bothersome symptoms because treatments are intense. So, the investigators~     developed SPARK (Supportive care Prioritization, Assessment and Recommendations for Kids), a~     website devoted to helping children track symptoms and providing a way to let doctors and~     nurses know which symptoms are bothersome. This study will examine the likelihood that~     children will complete SPARK once daily, help the investigators figure out how to improve the~     website so that children will use it, and help the investigators plan the large scale trial~     to test its efficacy in improving quality of life (QoL).~      Participants will be children with cancer or HSCT recipients who are 8-18 years of age and~     who are expected to be in hospital or in clinic daily for 5 days.To determine the feasibility~     of a randomized controlled trial (RCT) of symptom feedback to healthcare providers~   "
5451|NCT03495505|"~     This feasibility study will use CT scanning to identify the optimal location for placement of~     the WiSE-CRT system.~   "
5452|NCT03495492|"~     The purpose of this clinical trial is to identify 50 participants with Chronic Lymphocytic~     Leukemia (CLL) and follow their total white blood cell (WBC) counts and absolute lymphocyte~     counts after performing dermal chelation and administering nutritional therapy~   "
5453|NCT03495479|"~     Assessment of the effects of OMN54 (Aneustat) in a population of men with indolent prostate~     cancer who are otherwise healthy and free of significant co-morbidities and have chosen~     active surveillance for disease management. The investigators will assess how OMN54 affects~     PSA, overall tumor burden in addition to any changes in urinary flow. Other biomarkers will~     be tested to follow disease evolution.~   "
5454|NCT03495466|"~     The study design is a prospective randomized control trial. Four surgeons will enroll up to~     30 patients in the study. Patients will be asked to participate if they plan to undergo~     bilateral carpal tunnel release with one of the study surgeons, are greater than 18 years of~     age but younger than 89, have had no prior carpal tunnel surgery, and agree to undergo carpal~     tunnel surgery under two different types of anesthesia. If patients meet these criteria and~     agree to participate in the study, they will be consenting to have one hand operated on with~     local only anesthesia and the other hand with local anesthesia with sedation. The patient~     will randomly be assigned to have one of the two anesthetic methods for the first carpal~     tunnel release, followed by the other anesthetic for the second carpal tunnel release. The~     two surgeries will be completed by the same surgeon and may be performed at any time interval~     apart; however, the investigators will recommend that patients get the second surgery within~     4 weeks of the first. The particular surgical technique of carpal tunnel release will be~     performed according to the individual surgeon's preference, but the same technique will be~     used on both wrists. The surgeon will discuss the proposed advantages and disadvantages of~     each anesthetic method prior to enrolling the patient (advantages and disadvantages discussed~     above). The treating surgeons will continue to utilize their standard surgical technique on~     each side, regardless of a patient's participation in the study.~   "
5455|NCT03495453|"~     This single center prospective, randomized study will be conducted to investigate plaque~     removal and luminal gain using CSI's DIAMONDBACK 360® Peripheral Orbital Atherectomy System~     (OAS) (St.Paul, MN) versus Medtronic's Hawkone Directional Atherectomy system (DAS)~     (Minneapolis, MN) assessed by angiography and Intravascular Ultrasound (IVUS) in patients~     diagnosed with symptomatic obstructive femoro-popliteal disease will be analyzed. Both~     devices have received clearance by the Food and Drug Administration (FDA) for use by the~     label indication.Subjects will be randomized in a 1:1 fashion to receive treatment with~     either OAS (using CSI device) followed by Inpact Admiral drug coated balloon (DCB) or DAS~     (using the Hawkone device) followed by DCB. Subjects in both arms will undergo IVUS before~     and after atherectomy, as well as at the conclusion of the procedure. Clinical data will be~     collected at baseline, immediately prior to the procedure, during and immediately after the~     procedures, and within 30 days, 6 and 12 months office visits after the procedure. Data may~     also be collected at office or hospital visits that are not scheduled but occur up to 12~     months after the procedure, if they pertain to treatment related to the obstructive SFA~     disease. Data to be collected for this study includes demographics, medical history,~     procedural parameters and follow-up. The study will be conducted at one study center, 90~     subjects will be enrolled in the trial with plan to accrue 60 subjects - 30 patients enrolled~     in the OAS arm and 30 patients enrolled in the DAS arm. The duration of the study is expected~     to be approximately 2 years from the date of first enrollment (1 year for enrollment of 60~     subjects and a year for follow-up).~   "
5456|NCT03495440|"~     This study is designed to evaluate a preventive intervention program designed to support~     families (parents and typically developing adolescent siblings) that include a child with an~     intellectual and/or developmental disability. Participant families will be randomly assigned~     to either the treatment condition, in which they will receive psychoeducation and~     communication coaching over a four-week period, or the control condition, in which they will~     receive self-study materials. All subjects will participate in a pre-test assessment and~     three post-test assessments over the course of the year.~   "
5457|NCT03495427|"~     This study will enroll 60 patients previously enrolled to MCC#18523, A Validation Study on~     the Impact of Decipher® Testing on Treatment Recommendations in African-American and~     Non-African American Men with Prostate Cancer: (VANDAAM) that had high risk Decipher test~     results (Decipher score >0.45). Patients with a high genomic classifier (GC) score at~     diagnosis will be approached for formal consenting for PSMA-PET imaging at 2 years post~     treatment.~   "
5476|NCT03495180|"~     Over the past few years, significant advances have begun to be made in the development of~     particular measures as valid biomarkers or surrogate markers for the presence of acute and~     chronic pain. Many of these advances have been made because of the development of new and~     improved technologies, for example in the fields of imaging and genetics. Research is now~     showing brain activity and brain organizational changes associated with the presence of pain.~     Various factors have been found in the blood that is associated with the presence of pain.~     Research is also suggesting that pupil responses to a variety of stimuli may predict the~     presence of pain. And machine learning analysis of videos has found facial movement patterns~     in both animals and humans that are correlated with the presence of pain.~      This is a pilot study to investigate whether components of a person's electrical brain~     activity do reflect pain sensation.~   "
5458|NCT03495414|"~     Hypersexual Disorder (HD), sometimes called sexual addiction, is a disorder with intense~     sexual desires and psychological preoccupations that lead to out-of-control sexual activities~     with severe consequences. HD is related to higher risks of HIV infection and an important~     risk factor for committing sexual crimes. The prevalence of HD is 3-6% of the general~     population, thus, a significant burden for society. The neurobiological mechanisms behind HD~     are still unknown, and there is still a great need for causal treatments.~      This study is aimed at identifying neurobiological and psychological mechanisms underlying HD~     as a basis for treatment development. The overall goal is to improve mental health, quality~     of life, diagnosis and treatment options for affected individuals, and to reduce the impact~     HD can have on society. Patients with HD will be recruited at Karolinska University Hospital~     in close collaboration between endocrinologists, psychologists, psychiatrists, and brain~     researchers at Karolinska Institutet. Cases and healthy controls will undergo brain scans~     (MRI), psychological and blood tests to quantify neurobiological, cognitive, and behavioral~     aspects of HD.~      This study is directly integrated into clinical practice, can identify important targets for~     interventions and factors predicting treatment outcomes. This study is essential for a better~     understanding of HD, the improvement of treatments, and can have significant impact on the~     prevention of HIV infections and sexual crimes.~   "
5459|NCT03495401|"~     The purpose of this study is to investigate the effects of double fortification (iron and~     zinc) in synbiotic milk (L.plantarum Dad13 and fructooligosaccharides) on under 5 years~     stunted children growth, gut microbiota composition, blood zinc and hemoglobin level, and~     cognitive level.~   "
5460|NCT03495388|"~     Each year, in the U.S. alone, >6 million children undergo painful surgery; up to 50% of them~     experience significant and serious side effects with opioids and inadequate pain relief.~     Though 60% of this inter-individual variability in responses results from genetic variations,~     there is an almost complete lack of understanding of how specific genetic variability affects~     pain and of the adverse effects of opioids, especially in children. In this project the~     investigators will focus on oxycodone, a standard and preferred post-surgical oral analgesic~     in children~      The purpose of this research is to study serious immediate and long-term clinical problems~     from both surgical pain and oxycodone use in children and adolescents to improve the safety~     and effectiveness of surgical pain relief.~      The long-term goals are to improve the safety and effectiveness of surgical pain relief with~     opioids (a class of drugs/pain relievers) and to minimize the societal burden of disabling~     Chronic Persistent Surgical Pain (CPSP, which is pain that persists even after the expected~     healing time from surgery) and Opioid Dependence (OD) by preoperative risk predictions and~     personalized care with the right dose of the right pain medication for each child.~      The overall objective is to determine the impact of risk factors on oxycodone's immediate and~     long-term negative postoperative outcomes and to personalize dosing in children undergoing~     outpatient and major inpatient surgery.~   "
5461|NCT03495375|"~     A multicentre randomized double-blind placebo controlled parallel design (10 weeks) and open~     label (10 weeks) study investigating probiotic supplementation in highly impulsive adults~     (18-65 yrs; N=180). The probiotic studied is Synbiotic2000Forte that contain three~     well-studied anti-inflammatory lactic acid bacteria (LABs) and four fermentable fibers:~     Pediococcus pentosaceus 5-33:3, Lactobacillus paracasei subsp paracasei 19, and Lactobacillus~     plantarum 2362 in combination with the following four fermentable fibres: betaglucan, inulin,~     pectin and resistant starch. With this study we aim to detect, whether treatment with~     probiotics is effective in adults with high levels of impulsivity, compulsivity, and~     aggression.~   "
5462|NCT03495362|"~     There is a lot of evidence to show that the yeast beta-glucan has immunomodulatory,~     anti-inflammatory, anti-infective effects.However,few work was done on the relationship~     between yeast bata-glucan and the immune function of diabetic patients. This is a randomized~     double-blind trial, aiming to study the effect of yeast beta-glucan on immune system of~     prediabetic patients. Firstly, the investigators will go into the efficacy of yeast~     beta-glucan on improving the clinical symptoms of prediabetics. Secondly, the investigators~     will study the mechanism of yeast beta-glucan on enhancing the immune function and improving~     the inflammatory response.~   "
5463|NCT03495349|"~     Diabetes is a frequent and serious disease, with many complications. Diabetic foot ulcers are~     a frequent complication. Infection of diabetic foot ulcers is common, and requires heavy~     medical and/or surgical treatments. Antibiotherapy is one of the main options for the~     treatment of the diabetic foot ulcers, but it has many side effects.~      The aim of this study is to evaluate effectiveness and safety of medical treatments, in this~     population of patients.~   "
5464|NCT03495336|"~     Purpose/Objective: The aim of this study is to investigate the impact of boiled unfiltered~     (Turkish) coffee consumption on the plasma cardiovascular risk parameters of healthy~     subjects. The study also explores whether two unfiltered boiled (Turkish) coffee beverages~     that differ in content due to different roasting degrees will differentially affect~     cardiovascular biomarkers.~      Methods: In this crossover intervention study, healthy, nonsmoking, habitual Turkish coffee~     drinkers (n=28) were randomized to consume at least 3 cups of Light (LR) or Dark (DR) roast~     Turkish coffee brews per day for 4 weeks after a washout period (WO) of 2 weeks. Subsequent~     to each coffee abstinence period, both groups received the alternative intervention. After~     the first WO and the coffee intervention periods, anthropometric measures, blood pressure,~     heart rate and 13 biochemical parameters were collected and dietary records were completed.~   "
5465|NCT03495323|"~     This research study is studying a combination of a targeted therapy and an immune therapy as~     a possible treatment.~      The drugs involved in this study are:~        -  Prexasertib (LY2606368)~        -  LY3300054~   "
5477|NCT03495167|"~     To assess tolerability of SyB C-1101 when administered orally BID for 21 days followed by a~     7-day observation period in patients with recurrent/relapsed or refractory myelodysplastic~     syndrome in order to determine a recommended dose (RD). To assess safety, efficacy and~     pharmacokinetics.~   "
5478|NCT03495154|"~     A multi-center post-market single arm prospective study of Parietene™ DS Composite Mesh in~     subjects undergoing ventral hernia repair to confirm its clinical safety and performance in~     the short (1, 3 months), mid (12 months) and long term (24 months)~   "
5491|NCT03494985|"~     This study assessed the efficacy of three dry mouth products (including an experimental~     Oralbalance gel, oral rinse, and moisturizing spray) to relieve the feeling of dry mouth~     compared to water, in dry mouth population over a period of 28 days.~   "
5466|NCT03495310|"~     In addition to diet and sedentary lifestyle, factors such as stress, depression and anxiety~     have been found associated in up to 86% of cases of obesity in children. Mindfulness is a~     method based on the concentration of attention, awareness and meditation, which has been~     successfully used to reduce stress, depression and anxiety in individuals with some pathology~     in the short term (eight weeks).~      Objective: To determine if an intervention with mindfulness is effective to reduce the~     stress, appetite, and body weight of a group of school children with obesity and stress~     comparing them with a group that receives conventional therapy.~      Methods For a controlled clinical trial, 60 children of 10-14 years of age with obesity (BMI>~     2 SD) and stress (Spence scale> 60) will be selected, and randomly assigned to a group that~     receives the intervention with mindfulness (M8S), or to the control group (TC);The~     intervention with Mindfulness will be done once a week for 8 weeks. Measurements of BMI,~     glucose, leptin, ghrelin, cortisol and insulin will be carried out at the beginning of the~     study, and repeated at the end of the intervention and eight weeks after finishing the~     intervention to evaluate relapses.~   "
5467|NCT03495297|"~     This study will test the hypothesis that implantation of a subcutaneous implantable~     cardioverter defibrillator (S-ICD) without performing a defibrillation test is non-inferior~     to S-ICD implant with a defibrillation test with regards to the primary endpoint failed first~     shock in a spontaneous arrhythmia episode when implant position is confirmed with PRAETORIAN~     score.~   "
5468|NCT03495284|"~     A 2-period randomized cross-over trial will be conducted to determine the effect of~     incorporating 1 medium size potato, compared to an isocaloric portion of refined grains, on~     fasting glucose levels, insulin sensitivity, blood pressure, lipids and lipoproteins,~     arterial stiffness, body weight, gut microbiome, and dietary intake.~   "
5469|NCT03495271|"~     Individuals on dialysis due to kidney failure have very prescriptive diets. These diets help~     increase dialysis effectiveness and help patients control blood levels of electrolytes~     including potassium and phosphate, acid-base balance, blood pressure, and fluid between~     dialysis treatments. However, patient compliance with these diets often can be very low, and~     one reason for this low compliance is disguesia (abnormal taste sensations) which can make~     the diets unpalatable. This experiment tests the hypothesis that disguesia, and subsequent~     lack of adherence to a dialysis friendly diet, is a result of either vascular taste (tasting~     your own blood through the basolateral side of taste cells) or altered chemical composition~     of saliva in between dialysis appointments. However, to study these hypotheses, data are~     needed on the types of substances that may contribute to the disguesia. Substances for which~     the concentration is influenced by kidney function (in healthy people) or dialysis (in~     patients) are the prime candidates for the disguesia under our hypotheses. Thus, this~     experiment tests whether taste or flavours experienced from sodium, calcium, potassium,~     creatinine, urea, phosphates, glutamate, and iron may be related to altered taste experienced~     by patients on dialysis.~   "
5470|NCT03495258|"~     Kingston General Hospital is committed to upgrading the surgical treatment platform for~     benign prostate surgery. Vaporization Surgery, either laser-vaporization or~     electo-vaporization is becoming a standard of therapy for benign prostatic hyperplasia~     rather than the traditional transurethral resection of the prostate. However many Canadian~     hospitals have been slow to adopt an updated program because of evolving competing technology~     systems as well as unknown cost, efficacy, complication and patient/surgeon satisfaction~     considerations. KGH has been recognized as a centre of excellence in evaluating medical~     therapy for BPH and studies from the institution have impacted BPH care nationally and~     abroad. Laser and other state of the art BPH surgical technologies are being purchased by~     Ontario hospitals, including the local area, with no prospective assessment process. Kingston~     is uniquely advantaged to undertake a randomized comparative study of two of the most~     promising technology platforms because the investigators have the experience and expertise to~     perform the study in a hospital and surgeon naive institution.~      The investigators propose to directly compare two vaporization techniques, laser and plasma~     vaporization systems. The investigators will be able to answer the most important questions~     in technology introduction and technique into our hospital system - cost, efficacy, safety~     and satisfaction. The results will inform KGH (and other similar Ontario centres) on the~     advantage or not (financial and patient care related) of investing in a BPH state of the art~     vaporization technology.~   "
5471|NCT03495245|"~     The study investigates the potential of using serum biomarkers to assess pain in fibromyalgia~     patients.~   "
5472|NCT03495232|"~     In this project the investigators wish to:~      Evaluate intra-operative and postop complications, longer term survivorship and patient~     reported outcome measures (PROMs) following primary total knee replacement using Persona~     Total Knee system.~      This project is carried out as prospective cohort study. Recruitment of participants to this~     project is expected to begin in October 2016 or as soon as permission from the Regional~     Ethics Committee and the local Data Protection Agency is obtained as required. A total of 700~     participants (including 155 participants from a randomized controlled trial (RCT)~     investigating the Persona and the Nexgen total knee systems, which is separately submitted to~     the ethics committee) are to be included at several centers in the nordic region. Recruitment~     is expected complete after a period of 1,5 years per site. The patient follow-up visits are~     expected to be completed 2 years after recruitment of the last participant. Survivorship will~     be collected until 10 years after the recruitment of the last participant.~      Participants are seen on an outpatient basis at 3 months and 1 and 2 years postoperatively.~     After the 2 year follow-up visit the patients will be followed for survivorship through the~     National Knee Arthroplasty Registries at 5, 7 and 10 years postoperatively.~   "
5473|NCT03495219|"~     To establish to what degree individuals can increase esophageal high pressure zone (HPZ)~     after instruction in deep breathing as evidenced by concurrent manometric pressure readings.~   "
5474|NCT03495206|"~     The primary objective is to evaluate the safety and tolerability of single ascending dose of~     Y-2 sublingual tablets in healthy male and female adult subjects. The secondary objective is~     to characterize the single-dose pharmacokinetics of Y-2 sublingual tablets in healthy male~     and female adult subjects.~   "
5475|NCT03495193|"~     The goal of this research is to identify an intervention that will improve cognition and~     sleep in persons with PD.~   "
20086|NCT03304054|"~     Efficacy and safety of amifampridine phosphate in improving the activities of daily living~     for patients with antibody positive MuSK myasthenia gravis.~   "
5479|NCT03495141|"~     Eligible participants are those who are members of the general surgery residency pediatric~     gastroenterology fellowship, and adult gastroenterology fellowship. Through a~     randomized-controlled trial, participants will fill out a baseline set of demographic~     information including year of training, approximate number of colonoscopies to date,~     specialty, age, sex and handedness. Participation in this activity is completely voluntary.~     Trainees will be randomized to one of two groups. Either first participating in an unassisted~     colonoscopy module twice and then taking a questionnaire and then transitioning to a~     supervised/coached colonoscopy module session twice and taking a questionnaire, versus the~     reverse, in which the participant first partakes in a supervised/coached colonoscopy module~     session twice and then transitions to performing a colonoscopy module twice, unassisted.~     Objective measures will be assessed by the module software and supervising faculty.~     Specifically, using individuals' survey responses to see if early supervision improves survey~     scores. Survey questions focus on student learning, completing module objectives and faculty~     performance in simulation. The survey will also ask subjects to self-rate their scores and~     comfort level with endoscopy skills. Survey responses will not be linked to an individuals'~     performance in their program training and endoscopy coaches will not be made aware of the~     survey responses.~   "
5480|NCT03495128|"~     Space flight is associated with detrimental changes to the human body, including bone and~     muscle loss, fluid changes and deconditioning of muscles in the heart and blood vessels. Bed~     rest experiments, on Earth, are used to study these changes in healthy volunteers, as the~     disuse of muscles, and impact on the body, mimic the changes seen in the low-gravity~     environment of Space. Moreover, these changes are similar to those reported in people who~     remain in bed for long periods of time, such as is seen in intensive care or stroke patients,~     and bed rest studies also allow the physiological and biochemical impacts of this confinement~     to be investigated. For example, we know from previous research that muscle inactivity can~     lead to the development of resistance to the action of the hormone 'insulin', which is a~     longer term risk factor for the development of type 2 diabetes. Previous studies suggest that~     this inactivity-induced insulin resistance occurs within the first 48 hours of~     immobilization. However, it is not clear whether the biochemical and physiological processes~     underlying these short-term responses to inactivity are the same as those seen in the longer~     term. The current study aims to investigate the biochemical and physiological changes seen~     after 3 days of bed rest and to compare to those measured in a previous 57 days bed rest~     study carried out at Institut Médecine Physiologie Spatiale (MEDES; Toulouse, France). A~     3-day period of reconditioning will subsequently be used to determine if these changes can be~     readily reversed.~   "
5481|NCT03495115|"~     This study is looking at a breast cancer screening technique, restriction spectrum imaging~     (RSI), as a possible alternative to the breast Magnetic Resonance Imaging (MRI) used by most~     healthcare professionals.~      The technique involved in this study is:~      -Restriction Spectrum Imaging (RSI)~   "
5482|NCT03495102|"~     The purpose of this study is to evaluate the efficacy and safety of investigational doses of~     once weekly dulaglutide when added to metformin in participants with type 2 diabetes with~     inadequate blood sugar control.~   "
5483|NCT03495089|"~     Diabetes mellitus is the leading cause of polyneuropathy in the Western world. Diabetic~     neuropathy is a frequent complication of diabetes and may have great clinical transcendence~     due to pain and possible ulceration of the lower extremities. It is also a relevant cause of~     morbidity and mortality in patients with diabetes. Although the cause of polyneuropathy in~     patients with diabetes is only partially known, it has been associated with chronic~     hyperglycaemia suggesting the possible aetiopathogenic implication of advanced glycosylation~     end-products. The strategy of choice in the medical management of diabetic neuropathy is~     early detection since glycaemic control and the use of certain drugs may prevent or slow the~     development of this disease. Diabetic neuropathy most often presents with a dysfunction of~     unmyelinated C-fibers, manifested as an alteration of the sweat reflex of the eccrine glands.~     This dysfunction can now be demonstrated using a newly developed technology which measures~     dermal electrochemical conductivity. This noninvasive test is easy and cost-effective. The~     aim of the present study is to evaluate the feasibility and effectiveness of dermal~     electrochemical conductance measurement (quantitative expression of the sudomotor reflex) as~     a screening test for the diagnosis of diabetic neuropathy in patients in primary care.~   "
5484|NCT03495076|"~     Research has shown that chronic pain is related to variety of perceptual distortions. Little~     is known on how acute pain experience influences perception, especially precision of touch.~     This project is aiming to test the hypothesis of pain as a process of biological value~     leading to improvement in tactile acuity.~   "
5485|NCT03495063|"~     The purpose of this study determine the difference in hemodynamic effects of synthetic and~     natural caffeine consumption in healthy individuals through blood pressure (central and~     peripheral) assessment. Participants will randomly be assigned to consume either one 8oz cup~     of coffee containing 400mg of caffeine (increased caffeine using concentrated coffee) or one~     8oz cup of coffee-flavored drink with approximately 400mg synthetic caffeine from capsules~     dissolved in it.~   "
5486|NCT03495050|"~     Prospective non interventional, observational registry of 150 patients undergoing TAVI with~     Evolut platform for bicuspid aortic stenosis.~   "
5487|NCT03495037|"~     This study evaluates the efficacy of Real-World Strategy Training (RWST) compared to a~     psycho-education workshop for improving everyday life performance in older adults with~     subjective cognitive decline (SCD). Participants will be randomly assigned to receive one of~     these approaches.~   "
5488|NCT03495024|"~     To test the feasibility of studying effects of smoking cessation with varenicline on~     antipsychotic drug-induced neurological side effects, we propose a 12 week pilot study of~     smoking cessation treatment with varenicline in 10 schizophrenia or schizoaffective disorder~     patients who are actively smoking and have pre-existing TD while receiving stable doses of~     antipsychotics. Subjects will be followed after a 2 week baseline period to assess changes in~     smoking status and neurological symptoms using standardized rating scales. The aim is to~     examine clinically significant effects on antipsychotic-induced neurological side effects~     that may warrant further investigation.~   "
5492|NCT03494972|"~     The aim of this study was to investigate the effect of an oxytetracycline impregnated gauze~     drain on the incidence of alveolar osteitis (AO) and postoperative pain during the first week~     after mandibular third molar surgery.~   "
5496|NCT03494920|"~     The study will be a multicentre, prospective, randomized, open label, blinded endpoint~     (PROBE) phase 3 trial (2 arm with 1:1 randomization) in ischemic stroke patients within 4.5~     hours of stroke onset. Randomised patients will be stratified for site of baseline arterial~     occlusion into one of three groups: 1. internal carotid artery (ICA) 2. middle cerebral~     artery (MCA) 3. basilar artery (BA). Patients will be randomised to either bridging~     intravenous thrombolysis with endovascular clot retrieval (ECR), or direct endovascular clot~     retrieval.~   "
5497|NCT03494907|"~     The purpose of this study is to assess the effects of single dose seltorexant on QT/QTc~     intervals and electrocardiogram (ECG) morphology at therapeutic and supratherapeutic~     exposures in healthy adult participants.~   "
5498|NCT03494894|"~     Cytobacteriological examination of sputum and bacteriological sampling in the middle meatus.~   "
5499|NCT03494881|"~     This is an exploratory study designed to generate preliminary data in evaluating the efficacy~     of Nucala in the treatment of chronic spontaneous urticaria.~   "
5500|NCT03494868|"~     Preoperative fasting and surgery can cause metabolic stress and insulin resistance. Oral~     carbohydrate loading has been shown to attenuate the development of insulin resistance in the~     non-pregnant population undergoing many different types of surgery. Pregnant women have an~     increase in insulin resistance and therefore may further benefit from a preoperative~     carbohydrate load prior to cesarean delivery. Although woman in the UK receive a carbohydrate~     drink prior to elective cesarean delivery, the metabolic effects of these drinks on the~     mother and neonate have not been evaluated.~   "
5501|NCT03494855|"~     Synthetic MR Technologies has created a quantified imaging solution - SyMRI - to enable~     radiologists to acquire quantified images and always obtain the best contrast images. This~     study represents an attempt to assess the clinical utility of this software.~   "
5502|NCT03494842|"~     To study the effectiveness of the pain relief method of transcutaneous electrical nerve~     stimulation (TENS) for women who will undergo suction evacuation under conscious sedation for~     first trimester termination of pregnancy.~   "
5503|NCT03494829|"~     Observation study about physical activity, motor competence, pulmonary function, and health~     related quality of life in children, surgically treated for early onset scoliosis~   "
5504|NCT03494816|"~     NAXIVA is a study of axitinib in patients with metastatic and non-metastatic renal cell~     carcinoma with venous invasion. Patients will be given axitinib (twice daily) for 8 weeks (at~     an escalated dose) and the response of the venous invasion will be assessed.~      Blood, urine and tumour tissue samples will be taken prior to and during therapy to evaluate~     biomarkers of treatment response.~      The primary objective is to assess the response of the thrombus to axitinib. Its thought that~     axitinib will reduce the extent of the thrombus in the inferior vena cava will reduce the~     extent of surgical intervention.~   "
5505|NCT03494803|"~     Prostate cancer is a leading cause of mortality and morbidity.~      The purpose of this study is to develop and test non-invasive biomarkers based on methylation~     changes in PBMC, T-cells and circulated tumor DNA in prostate cancer patients.~   "
5506|NCT03494790|"~     Adult patients with suspected or confirmed infection and who will be sampled for blood~     culture will be recruited. Blood samples are collected for the analysis of matrix~     metalloproteinases (MMP) and their inhibitors. We also aim to analyse metabolic changes and~     use the samples for analysis of blood lactate, metabolomics, and fibroblast growth factor 21~     (FGF-21) as well. The primary aim of the study is to test the performance of MMP-8 in finding~     severely ill patients who will need treatment in high dependency unit or intensive care. The~     secondary aim is to study the metabolic changes in acutely ill patients with infection.~   "
5507|NCT03494777|"~     This study will implement an intervention in a two-year randomized controlled trial (RCT) to~     establish efficacy on viral suppression as a biological endpoint, compare the effectiveness~     of two different modes of implementation (including one entirely based on readily available~     clinic data), and investigate cost-effectiveness. Participants in the first intervention~     group (T1, n=110) will be eligible for small lottery prizes based on timely clinic visits,~     and qualify for an annual lottery conditional if demonstrating viral suppression; those in~     the second group (T2, n=110) will draw prizes conditional on electronically measured~     adherence at each clinic visit, and also participate in an annual lottery that is conditional~     on high adherence throughout the year. The control group (n=110) will receive the usual~     standard of care. Assessments will be conducted at baseline and then every six months.~     Primary outcomes are undetectable viral load and electronically measured adherence.~   "
5508|NCT03494764|"~     Ulcerative colitis (UC) is a chronic inflammatory bowel disease associated with recurrent~     mucosal inflammation. Clinically, the disease is characterized by bloody diarrhea, abdominal~     pain, and constitutional symptoms such as fever and weight loss. Treatment strategies vary~     based on disease activity and target various aspects of the inflammatory cascade. Options~     include: anti-inflammatory drugs (mesalamine), immunosuppressive or modulatory medications~     (corticosteroids, thiopurines, cyclosporine) and biologic agents (Anti-TNF). Disease severity~     can be wide ranging, and nearly 25% of UC patients are hospitalized for acute severe disease.~     Of these patients, 30% will undergo colectomy after the acute episode, a quarter of which~     will experience post-operative complications (1, 2). Although there has been great progress~     in treatment of UC over the past decade, even with the anti-TNF agent infliximab, the~     one-year remission rate for patients not responding to conservative management is barely 20%~     (3). Furthermore, corticosteroids have significant long-term consequences and immune~     suppressive drugs such as 6-mercaptopurine, azathioprine and infliximab have been associated~     with serious adverse events including life-threatening infections and lymphomas (4, 5). With~     growing evidence that the pathogenesis of UC is multi-factorial and involves a complex~     interaction of genetic and environmental factors, newer treatment modalities are being~     evaluated to target the mucosal immune response and mucosal inflammatory regulatory system~     (6, 7).~      Hyperbaric oxygen offers a promising new treatment option since it targets both tissue~     hypoxia and inflammation. Recent small scales studies evaluating the impact of hyperbaric~     oxygen treatment in acute ulcerative colitis flares demonstrated improved outcomes (8, 9).~     The mechanisms underlying the improvement are not known. In this study, we will treat~     ulcerative colitis flares with hyperbaric oxygen and measure changes in both markers of~     tissue hypoxia and inflammation. We hypothesize that hyperbaric oxygen will (a) improve~     outcomes, and (b) show reductions in markers of both tissue hypoxia and inflammation.~   "
5509|NCT03494751|"~     Verify the effectiveness of a Heart Monitor in preventing events in patients over 18 years~     after acute myocardial infarction in a clinical unit. Patients with neurological disease or~     congenital heart disease we excluded from the study.~   "
5510|NCT03494738|"~     The objective of the study is to validate epigenetic changes as biomarkers in a prospective~     sampling of newborn blood samples collected at birth (umbilical cord blood) and during~     routine screening (heel stick blood) in newborns concurrently tested for alcohol exposure~     levels by PEth blood spot testing.~   "
5511|NCT03494725|"~     The aim of this study is to assess whether a 5 week intake of a probiotic (Lpc-37) can~     modulate stress and anxiety experienced by healthy subjects during and after an acute~     stressor compared to placebo. To measure stress and anxiety, markers of the~     hypothalamic-pituitary-adrenal (HPA) axis activity and questionnaires will be assessed~     before, during and after the Trier Social Stress Test (TSST). The results of this study~     indicate if the chosen study design is suitable to discover stress-related effects of~     probiotics.~   "
5512|NCT03494712|"~     The purpose of the study is to assess, the safety and tolerability of single ascending doses~     of S 95010 and to assess the pharmacokinetics (PK) of S 95010.~   "
5513|NCT03494699|"~     This randomized controlled trial is for investigating the effects of multidisciplinary~     intervention program on cognition and activity of daily living ability in community dwelling~     healthy elderly. The intervention consists of cognitive group training every month, daily~     home cognitive training using cognitive training smartphone application, record of weekly~     physical activity and body weight and feedback program, and alcohol and smoking cessation~     monitoring and feedback program. The total duration of intervention is 1 year, and the~     table-based cognitive screening test and the patient-reported questionnaires to evaluate~     subjective memory decline, quality of life, depression, and activity of daily living are used~     for outcome measures.~   "
5514|NCT03494686|"~     The investigators conduct a prospective, randomized trial to assess the benefits of~     performing large loop excision of the transformatione zone (LLETZ) under local anesthesia and~     compare it to LLETZ under general anesthesia. The primary endpoint of this study is women´s~     satisfaction.~   "
5515|NCT03494673|"~     Brain white matter hyperintensities (WMHs) are prevalent in migraineurs, of which the~     mechanism is still unclear. The investigators aimed to test the spatial association between~     areas with reduced cerebrovascular reactivity (CVR) to hypercapnic stimuli and consequent~     development of WMHs.~   "
5516|NCT03494660|"~     Post-market clinical outcomes study to collect data on the short- and long-term outcomes for~     subjects who are undergoing or have undergone the Subchondroplasty® (SCP®) Procedure in the~     hip in a standard clinical setting. Outcomes to be assessed include medication usage, pain,~     function, activity levels and patient satisfaction.~   "
5517|NCT03494647|"~     This study is to learn more about braces that may help young athletes diagnosed with Sever's~     disease. Young athletes with this diagnosis who are seen by a Sports Medicine doctor will be~     asked it they want to be a part of the study. Patients who want to be in the study will be~     randomly assigned to wear one of two kinds of braces to treat their foot pain via~     randomization scheme independently created by a statistician. The subjects will be given the~     brace for free. The subjects will also answer survey questions about the brace when they~     first see the doctor, then at one, two, and three months after their first visit. Data~     collected in this study will help doctors gain a better understanding of how to treat young~     athletes who do sports without shoes who are diagnosed with Sever's disease.~   "
5518|NCT03494634|"~     Study of Chidamide as a Single-agent Treatment for Patients With Recurrent and Metastatic~     Epstein-Barr virus (EBV)-associated Solid Tumors~   "
5519|NCT03494621|"~     This proposed project will engage American Indian communities through existing partnerships,~     utilizing a Community Based Participatory Research (CBPR) methodology to design a group~     intervention program to increase the safety of infant sleep environments. Compelling evidence~     from research in other racial populations suggests that family and cultural norms, attitudes~     and personal beliefs about infant sleep, safety and comfort are strongly associated with the~     choice of infant sleep environment. It may be possible that the current safe sleep messages~     are in conflict with inherent cultural beliefs within these communities. This conflict with~     the scientific recommendations regarding safe sleep may influence behavior, even in the~     presence of adequate knowledge about safe sleep practices. Preliminary discussions with many~     tribal leaders and elders suggest that this chasm between culture and scientific~     recommendations can be bridged with an intervention incorporating culture, education and~     resources. However, there is limited research on factors influencing infant safe sleep~     practices of American Indian mothers. This study will test the effectiveness of incorporating~     cultural beliefs and practices into an intervention package based on the American Academy of~     Pediatrics safe sleep guidelines that incorporates both education and provision of resources.~     Therefore, the research question is: Does a culturally specific safe sleep intervention,~     developed using CBPR, reduce the risk of unsafe infant sleep practices in Northern Plains~     American Indian communities?~   "
5520|NCT03494608|"~     This prospective single-center cohort study aims to identify the incidence of cognitive~     dysfunction after unruptured aneurysm operation and explore the influencing factors. The~     primary end point is the cognitive dysfunction at 6 months after operation.The features of~     cognitive function, mental status, neurological function recovery, and quality of life of~     patients with unruptured intracranial aneurysms at different time points would be analyzed.~   "
5521|NCT03494595|"~     The study aims to correlate the perioperative results of a device called thromboelastogram,~     which is used to detect coagulation abnormalities, with thrombotic complications during~     pediatric recipient liver transplantation.~   "
5522|NCT03494582|"~     This study will compare the vaginal versus the abdominal approach for the management of~     uterine prolapse~   "
5523|NCT03494569|"~     This phase I studies the side effects and best dose of total marrow and lymphoid irradiation~     when given together with fludarabine and melphalan before donor stem cell transplant in~     treating participants with high-risk acute leukemia or myelodysplastic syndrome. Giving~     chemotherapy, such as fludarabine and melphalan, and total marrow and lymphoid irradiation~     before a donor stem cell transplant helps stop the growth of cells in the bone marrow,~     including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem~     cells from a donor are infused into the patient they may help the patient's bone marrow make~     stem cells, red blood cells, white blood cells, and platelets.~   "
5524|NCT03494556|"~     Decision aids such as the HEART Pathway, Emergency Department Assessment of Chest Pain Score~     (EDACS), Revised Geneva Score and PERC Score have similar ability to accurately risk stratify~     Emergency Department (ED) patients with possible Acute Coronary Syndrome (ACS) and Pulmonary~     Embolism (PE) and have become standard practice in the ED setting. This study seeks to~     determine whether prehospital use of these decision aids is feasible and determine which are~     the most sensitive and specific for prediction of ACS and PE, respectively.~   "
5526|NCT03494530|"~     Edoxaban (also referred to as Lixiana) is an anti-clotting drug, approved by Health Canada~     for the prevention of stroke in patients with atrial fibrillation (abnormal heart rhythm).~     This study is being done to try to determine the best time to start apixaban treatment after~     an ischemic stroke has occurred.~      The purpose of the LASER study is to determine the safety of early edoxaban use after~     TIA/ischemic stroke in patients with atrial fibrillation using advanced MR imaging. This~     study will also gather information about participant general well being, mental status, and~     the effects of the TIA/stroke on daily living, as well as CT and MRI of the brain.~   "
5527|NCT03494517|"~     The primary aim of this pilot study is to prospectively quantify epileptiform activity in a~     cohort of preeclamptic patients before and after intravenous magnesium administration.~      Secondary aims will be the exploration of a potential association between epileptiform~     activity and the sFlt-1:PIGF ratio, as well as a correlation to clinical signs of~     preeclampsia.~      A positive finding may aid obstetricians to detect an increased convulsive risk by performing~     a simplified EEG early in the diagnostic path of preeclampsia. If confirmed in a larger trial~     positive correlations of an increased sFlt-1:PIGF ratio with epileptiform activity might be a~     risk marker for early severe preeclampsia, guiding obstetricians into clinical~     decision-making in regard to an increased maternal risk of eclampsia.~   "
5528|NCT03494504|"~     A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Clinical Trial~     to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solutions in Subjects with Acute~     Allergic Conjunctivitis~   "
5529|NCT03494491|"~     The aim of this research study is to characterize the fermentation of chitin-glucan fiber by~     assessing the volatile compounds released in the breath. For this purpose, an interventional~     study with control will be performed. After a single administration of 4.5 g of chitin-glucan~     fiber, the kinetic of production of exhaled volatile compounds (such as H2, methane, SCFAs,…)~     will be measured during twelve hours. These results will be compared to the exhaled volatile~     compounds measured during twelve hours after supplementation with 4.5g of maltodextrin~     (placebo).~   "
5530|NCT03494478|"~     Attention deficit disorder in adults with or without hyperactivity (ADHD) is a common~     disorder, affecting around 3% of the population. ADHD increases the risk of psychiatric~     disorders (mood disorders, sleep disorders, personality disorders, addictive behavior), risky~     behaviors, and vocational difficulties. Emotional dysregulation (ED) constitute a major~     hindrance in the daily life of subjects, with a great impact on the general functioning and~     the quality of life of the patients.~      The investigators want to determine the characteristics of patients with each type of ED~     (impulsivity, exacerbated emotional intensity, cyclothymia, borderline personality traits),~     and study the stability of these traits over time. Since circadian rhythms influence mood and~     circadian rhythms frequently occur in patients with ADHD, the investigators want to determine~     if there is a link between ED and instability in circadian rhythms. Finally, they would like~     to observe whether the ED evolves and according to whether or not treatment is taken~   "
5531|NCT03494465|"~     There are several publications that have demonstrated the protective role of cataract surgery~     against the development of long-term glaucoma, especially in cases of pseudoexfoliation~     glaucoma (PXFG). Cataract surgery in patients with pseudoexfoliation (PXF) is a procedure~     with higher rates of complications due to its smaller pupillary diameter and its greater~     zonular weakness, so lens extraction performed earlier could possibly reduce intra and~     postoperative complications. Given the severity and high prevalence of PXFG in our~     environment, investigators proposed a randomized clinical trial to evaluate the efficacy of~     cataract surgery in reducing the intraocular pressure (IOP) at 12 months and thereby change~     the course of the disease. The control group will have glaucoma treatment according to~     standard practice.~   "
5532|NCT03494452|"~     The research questions are if persons with low back pain (LBP) have lower trunk muscle~     strength, lower trunk muscle strength endurance and lower trunk muscle activity than healthy~     controls and if functional limitations because of LBP are related to the level of muscle~     strength, strength endurance and activity. To investigate this investigators will carry out a~     clinical assessment including questionnaires and a biomechanical assessment comprising muscle~     strength tests, muscle strength endurance tests and electromyographic (EMG) analysis of~     selected trunk muscles.~   "
5533|NCT03494439|"~     This study aims to determine the prevalence of anterior open bite and its etiological factors~     in a group of Egyptian children aged 8 years and above. patients who met the eligibility~     criteria will be given a questionnaire to fill followed by obtaining casts stabilized into~     occlusion to obtain the vertical and horizontal relationships.~   "
5534|NCT03494426|"~     Postmastectomy pain syndrome (PMPS) is a neuropathic pain that can follow surgical treatment~     for breast cancer, The antineuropathic medications (antidepressants and anticonvulsants) are~     disappointing and have low success rate. Continues Radiofrequency lesioning has been reported~     as treatment for several chronic pain conditions.The concept that the clinical effect of RF~     was caused by formation of heat had not been challenged. Thermocoagulation of nerve fibers~     would interfere with the conduction of nociceptive stimuli and pain would be relived.~     Thoracic sympathectomy has been done for many painful conditions that includes complex~     regional pain syndrome .It offers the benefit over stellate ganglion block as it blocks the~     Kuntz fibers that connect to the brachial plexus roots without passing through stellate~     ganglion.~   "
5535|NCT03494413|"~     This prospective interventional study investigates transpharyngeal sonography (TPS) as an~     additional neuromonitoring strategy to assess cerebral perfusion during cardiovascular~     surgery. In the first part of the study the investigators will investigate the feasibility of~     TPS for visualization of aortic arch branches including the innominate and the carotid~     arteries in patients undergoing cardiac surgery with cardiopulmonary bypass. In the second~     part the investigators plan to adopt the investigators previous experiences on TPS to a~     selected population of patients undergoing ascending aortic and/or arch repair in hypothermic~     circulatory arrest (HCA).~   "
5578|NCT03493854|"~     This is a global Phase III, two-arm, open-label, multicenter, randomized study to investigate~     the pharmacokinetics, efficacy, and safety of the fixed-dose combination (FDC) of pertuzumab~     and trastuzumab for subcutaneous (SC) administration in combination with chemotherapy in~     patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer in~     the neoadjuvant/adjuvant setting.~   "
5536|NCT03494400|"~     Introduction. Treatment with hormone therapy reduced the likelihood of tumor recurrence and~     metastasis in the patient. However, it has adverse effects such as: loss of bone mineral~     density, increase in body weight, metabolic changes and, consequently, lower quality of life.~     Physical training has been used as a means of reducing these and other adverse effects, but~     there is no definite protocol on which training model is effective, especially in patients~     who only use Tamoxifen or Aromatase Inhibitor as an adjuvant therapy for treatment of breast~     cancer.~      Objective: To compare the effect of aerobic training on body composition, metabolic and~     inflammatory variables, physical activity level, sleep, anxiety, depression, body image,~     fatigue, strength, flexibility and quality of life of women undergoing breast cancer~     treatment use Tamoxifen and Aromatase Inhibitor and women without cancer.~      Method. The sample will be formed by women without cancer and under treatment with hormone~     therapy being accompanied by the public service for treatment of breast cancer of the city of~     Presidente Prudente. A 24-week notification in which the face-to-face training group will~     undergo aerobic training three times a week on interspersed days and the group accompanied at~     a distance will perform as a preferred activity under a distance supervision of professionals~     every 14 days of return to attend the UNESP for the adequacy of the analysis and selection of~     attendance to the proposed activities. Evaluations of the variables of interest at the~     baseline of the intervention will be performed after 12 weeks and soon after the~     intervention. The investigators will analyze: biomarkers (TNFα, LDL, HDL, VLDL, as well as in~     the lipid profile (triglycerides, total cholesterol and LDL fractions ), glycemia, insulin,~     anthropometric measurements, physical activity level, sleep, pain, anxiety, depression, body~     image, fatigue, strength, flexibility. Trainings will be performed within the target zone of~     maximum heart rate. Comparisons between groups at each time point will be performed using~     Student's T-test for independent samples. The comparisons of the variables of interest at the~     initial moment and after 12 and 24 weeks will be made through the multivariate analysis,~     where the group effects, time and interaction of both will be compared. All analyzes will be~     performed in SPSS software version 24.0 and significance of 5%.~   "
5537|NCT03494387|"~     This study examines the risks and benefits of antioxidants and normal versus high inspiratory~     oxygen fraction during anaesthesia.~   "
5538|NCT03494374|"~     There is no definite evidence for the conservative treatment of pes planus. We want to verify~     the combination efficacy of orthosis and toe walking exercise for the treatment of pes~     planus.~   "
5539|NCT03494361|"~     The natural process of aging affects a few very specific timing parameters such as swallow~     reaction time and hyoid one movement velocity.~      Many swallow timing and bolus transit parameters appear to be unaffected by aging. We want to~     know the changes of kinematic variables according to the aging process.~      First hypothesis: There are probably be a protection mechanism that blocks functional loss~     progressing to kinematic abnormality. Muscle activation sequence change (i.e duration or~     amplitude) of the oropharyngeal muscles play an important role.~      Second hypothesis: Age-related differences in muscle activation patterns will also appear~     differently depending on the characteristics of swallowed food.~   "
5540|NCT03494348|"~     The aim of this study is to evaluate, over a 2 year period, the migration pattern, function~     and the possibility of anatomical reconstruction of a relatively new total knee arthroplasty~     (TKA) concept, the Persona. Sixty patients will be randomized into 2 groups of 30 patients~     each, with one group receiving the Persona TKA with a conventional Cruciate Retaining (CR)~     polyethylene articular surface and the other group with a newly developed Medial Congruent~     (MC) articular surface. Patients will be followed up with Radiostereometry (RSA),~     conventional radiography, outcome questionnaires, clinical evaluation and Computer Tomography~     (CT). The migration pattern of the components will be evaluated as well as the degree of~     anatomical reconstruction and clinical result.~   "
5541|NCT03494335|"~     In this exploratory study, we would like to investigate the background, perception, current~     use practices, potential unmet needs and/or challenges in regard to imaging procedures,~     imaging technology, or any other aspect related to the broader field of imaging.~   "
5542|NCT03494322|"~     Head & neck (H&N) cancer is the eighth most common cancer in the UK. Advanced H&N cancer~     which has come back after treatment or has spread to other parts of the body is incurable and~     the average life expectancy of these patients is less than a year. New drugs called immune~     checkpoint inhibitors work with the patient's own immune system to fight cancer. They are~     used in the clinic to treat a number of cancers, including H&N cancer. It may be possible to~     make immune checkpoint inhibitors more effective by combining drugs that work in different~     ways. In effect, attacking the cancer from different angles. Cetuximab is a well-established~     drug that works by blocking signals that tell cancer cells to grow and divide into more~     cells. It also engages with the immune system within the tumour. The trial aims to see if~     giving cetuximab along with an immune checkpoint inhibitor drug called avelumab is better at~     treating advanced H&N cancer than giving avelumab on its own.~      These two drugs have not been given together before, so to start with, the investigator plans~     to enrol a small number of patients and give the patients avelumab + cetuximab to make sure~     the combination is safe at the doses chosen. After this, the investigator plans to enrol 114~     patients with advanced H&N cancer. Half the patients will be treated with avelumab alone and~     the other half with avelumab + cetuximab. Both drugs are given intravenously in the hospital~     once every 2 weeks.~      Treatment lasts for up to a year and patients will be followed up for up to 2 years from the~     time they enter the study. Patients will be recruited from around 15 hospitals in the UK.~     Recruitment would be expected to start in the second quarter of 2018 and it will take about~     29 months (Safety run-in: 5 months; Phase II: 24 months) to recruit all the patients.~   "
5543|NCT03494309|"~     Patients with mandibular sub-condylar fractures underwent either either open reduction with~     internal fixation (ORIF) or closed reduction with external fixation (CREF) and were followed~     up for 6 months to assess treatment adequacy with the hypothesis that ORIF is superior to~     CREF.~   "
5554|NCT03494166|"~     Sample: The sample will be 344 ethnically diverse (at least 30% Hispanic) survivors who have~     a new diagnosis or localized recurrence of solid tumor cancer and elevated depression and~     co-morbid illnesses.~      Design: The SMART design incorporates two interventions with proven efficacy and addresses~     heterogeneity of survivors' responses by following the clinical logic of starting with one~     intervention, assessing its success, and continuing it when effective. High need survivors~     will be initially randomized to receive 1) weekly symptom assessment with referral for~     elevated symptoms to a printed Symptom Management and Survivorship Handbook (SMSH) or 2) a~     more intensive intervention adding SMSH to Telephone Interpersonal Counselling (TIP-C). After~     4 weeks, non-responders to SMSH alone on depression will be re-randomized to continue SMSH~     for 8 more weeks to allow for symptom resolution, or TIP-C will be added for the remaining 8~     weeks. Specific Aims:~      1. Test the effects of interventions on summed index of severity of 15 post-chemotherapy~     symptoms (primary outcome) and symptom-specific responses and times to response (secondary~     outcomes). Hypothesis 1.Survivors that starts with TIP-C+SMSH versus those that start with~     SMSH alone created by the first randomization will have better primary and secondary outcomes~     at weeks 1-13. Hypothesis 2. Among nonresponders to the SMSH alone after 4 weeks, survivors~     in TIP-C+SMSH as compared to the SMSH alone group created by the second randomization will~     have better primary and secondary outcomes at weeks 5-13.~      Hypothesis 3. Self-efficacy and social support will mediate improvements in the primary~     outcome at week 13.~      Aim 2. Compare symptom outcomes of intervention sequences against the benchmark low need~     group.~      Exploratory Aim. Explore which survivor characteristics are associated with responses to the~     SMSH alone during weeks 1-4 and optimal symptom outcomes during weeks 1-13. This will allow~     us to determine tailoring variables to inform decision rules for choosing intervention~     sequences for individual survivors in the future.~   "
5544|NCT03494296|"~     Decitabine is a cytosine analogue and is a specific DNA methyltransferase (DNMT) inhibitor.~     It directly inhibits DNMT by phosphorylating DNA and inhibits DNMT, thereby reversing DNA~     methylation and inducing tumor cells to Normal cell differentiation or induction of tumor~     cell apoptosis.Diffuse large B-cell lymphoma (DLBCL) is the most common pathological type in~     non-Hodgkin's lymphoma. The first-line chemotherapy regimen using~     Rituximab+Cyclophosphamide+Doxorubicin +Vincristine+Bonisone（R-CHOP）significantly increases~     the remission rate and disease-free survival of patients with DLBCL, but it is difficult to~     partially relapse. Long-term remission and survival rates in treating patients are not~     satisfactory.Due to the greater cardiac toxicity of adriamycin, more patients can not be~     uncomfortable, so the COP program is also widely used in patients with DLBCL, and achieved a~     good response rate.In 2008, the FDA had approved decitabine for the demethylation treatment~     of Myelodysplastic syndrome（MDS）. Over the years, good initial remission rates and better~     long-term survival rates have been achieved in patients with MDS.There are also a variety of~     clinical trials of decitabine for patients with solid tumors that have achieved significant~     clinical efficacy.Due to the high side effects of high-dose decitabine, patient tolerance is~     poor. Therefore, the purpose of this study was to evaluate the efficacy and safety of~     low-dose decitabine combined with Cyclophosphamide+Vindesine+Bonisone(COP) regimen (D-COP)~     4-6 course of treatment for relapsed and refractory diffuse large B-cell lymphoma.~   "
5545|NCT03494283|"~     CrossFit is a recent sport that has been democratized since the beginning of the 2000's in~     France. The 3 major studies of CrossFit injuries were conducted in the United States in 2014,~     Brazil in 2016 and the United States in 2017. They show a discrepancy in terms of injuries~     average, from 19.4% to 31% in relation to an upsurge in the number of CrossFit practitioners,~     the specific training or not of the coaches framing this activity, the practice or not in~     competition. The main locations of these wounds are highlighted at the shoulders, lumbar~     region and knees. In France, to date, no epidemiological studies have been conducted on this~     subject.~      Hypothesis: High incidence of injuries related to a lack of framing, or bad practice and~     ignorance of CrossFit practitioners.~      Objectives : Estimate the injuries incident due to the CrossFit practice over a 8-month~     period in an adult population who practice in clubs .~      Research, among the anthropometric, sociodemographic, environmental, and the nature and~     frequency of practice and training sessions, those which are associated with the occurrence~     of injury in this cohort.~   "
5546|NCT03494270|"~     This study will evaluate the efficacy and safety of high-intensity rosuvastatin and~     moderate-intensity rosuvastatin/ezetimibe in ASCVD patients.~   "
5547|NCT03494257|"~     This study aims to evaluate the effect of fixed brinzolamide-brimonidine combination on~     intaocular pressure after uncomplicated phacoemulsification surgery.~      Patients scheduled for phacoemulsification will be randomly assigned to 1 of 2 groups.~      The treatment group will receive 1 drop of brimonidine-brinzolamide fixed combination~     immediately after surgery, and the control group will receive no treatment. The IOP will be~     measured preoperatively and at 6, 12, and 24 hours postoperatively.~   "
5548|NCT03494244|"~     The use of acellular dermal matrix (ADM) has facilitated implant-based breast reconstruction,~     both in single-stage direct-to-implant (DTI) and staged tissue expander placement. Nearly~     half of all breast reconstruction procedures performed within the United States have~     incorporated ADM. Despite such widespread acceptance among both patients and plastic~     surgeons, manufacturers of ADM face difficulties in obtaining approval by the Food and Drug~     Administration (FDA) for use of their product as a medical device in breast reconstructions.~     ADM is defined as banked tissue and, as such, is approved for use as tissue support. Under~     section 510k of the Food, Drug and Cosmetic Act, ADM must exhibit soft tissue reinforcement~     of integument to be considered a medical device, a criterion that has yet to be~     physiologically or clinically defined. This distinction precludes the development and~     manufacture of xenogeneic ADM. The aim of this research is to compare reconstruction outcomes~     between ADM and Vicryl, a non-ADM control that is hydrolyzed and degraded within 6-8 weeks~     after surgery. The investigators propose a prospective cohort study to determine whether~     post-operative outcomes provide clinical and anatomic evidence for soft tissue reinforcement~     within the ADM group.~   "
5549|NCT03494231|"~     The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended~     Phase 2 dose (RP2D) of fully human anti-VEGFR2 monoclonal antibody, HLX06, in patients with~     advanced or metastatic tumors refractory to standard therapy. This study will also evaluate~     the pharmacokinetics, pharmacodynamics, immunogenicity and anti-tumor effect of HLX06 and~     explore the potential prognostic and predictive biomarkers.~   "
5550|NCT03494218|"~     The aim of this study was to translate the NCS from English into Chinese and determine the~     validity of this Chinese version.~   "
5551|NCT03494205|"~     A randomized controlled trial comparing Urtica comp. gel (Swissmedic listed medication in the~     category of Anthroposophic Medication without Indication) against standard skin care,~     examining its effect in prevention and treatment of radiation dermatitis in breast cancer~     patients under Radiation therapy.~   "
5552|NCT03494192|"~     Abnormal reduction of the AHD has been considered as one of the possible mechanisms in the~     aetiology of subacromial impingement syndrome. Maintenance of the AHD is crucial for~     prevention and rehabilitation of rotator cuff related disorders.~      The development of a rehabilitation treatment plan is based in part on the assessment of~     scapular motion and muscle deficits in patients with shoulder pain. Rehabilitation should be~     based on the identified impairments.~      The aim of this study is to evaluate the effects of scapula based and scapula&rotator cuff~     based rehabilitation programs on symptoms, functional limitations and AHD in individuals with~     subacromial pain syndrome and compare with health population.~   "
5553|NCT03494179|"~     The phase I/II clinical study is to investigate the safety, tolerability and~     pharmacokinetics/ pharmacodynamics of ICP-022.~   "
5576|NCT03493880|"~     Based on multiple studies, the immune (systemic inflammation) and nutrition index were~     correlated with short- and long-term prognosis for gastric cancer. With the increasing~     application of preoperative treatments (chemotherapy and chemoradiotherapy), the issues~     concerning how are the immuno-nutrition index be altered under the effects of perioperative~     treatments and what are the clinical values of these index should be clarified.~   "
5579|NCT03493841|"~     This is a three-week crossover study that will compare how the body absorbs and tolerates two~     different forms of lipoic acid: R form and racemic form.~   "
5555|NCT03494153|"~     Assessment of prognostic performances of CCU in CRA Recovery (CRAR) has already been explored~     but 1) Only in intra-hospital medicine, 2) in very variable timings. ACE Research focuses on~     the extra-hospital window and predictive value of Early CCU (within 12 minutes of~     rescucitation initiation) with ambitious endpoints : curable etiologies identification, early~     anticipation of ECMO procedures, early anticipation of organ donation process, and evaluation~     of intrinsic contribution criterion to resuscitation interruption.~      The primary objective of ACE study is to investigate the positive predictive value (PPV) of~     early ultrasound asystole on the absence of CRAR. The secondary objectives are multiple and~     innovative despite an observational design: impact on the morbi-mortality of the target~     population (frequency of curable etiologies, pre-therapeutic and therapeutic delays,~     morbidity...), delay of ECMO implementation of an ECMO (Extracorporeal Membrane Oxygenation),~     failure rate of organ donation due to overdelays, construction of a multifactorial score~     associated with CRAR.~   "
5556|NCT03494140|"~     The objective of this study is to confirm the clinical safety and efficacy of Viscontour®~     Serum Med in the hydration of facial tissue.~   "
5557|NCT03494127|"~     30 Veterans who are full-time wheelchair users will use personalized modular cushions for two~     weeks each. Personalized cushions will be created using a cushion fitting process the~     investigators have already developed and tested. Microenvironmental conditions will be~     monitored during use. A cost analysis will ensure the customized modular cushion applies~     value-driven principles. User satisfaction will be measured along with the effects on daily~     function, skin status and seated tissue health.~   "
5558|NCT03494114|"~     To test whether folate-based positron emission tomography (PET) imaging using 68Ga-EC2115 can~     differentiate chronic obstructive pulmonary disease (COPD) patients from control subjects and~     determine whether the PET signal correlates with measurements of inflammation and disease~     severity.~   "
5559|NCT03494101|"~     Stool and blood samples from patients with a non-typhoid Salmonella infection will be~     collected during an observation period of six months and analyzed for changes in the~     microbiota diversity and composition, mutation rates in the Salmonella strains and the~     specific immune response evoked by the infection. Findings are compared to healthy~     individuals and individuals with acute, infectious diarrhea caused by other microorganisms.~   "
5560|NCT03494088|"~     This study's primary aim is to explore the potential differences in the gut mycobiome of~     children with autism spectrum disorder compared to otherwise healthy children. The secondary~     objective of this study is to evaluate whether the presence of specific species of fungi~     (e.g. Candida tropicalis, C. albicans, or Saccharomyces cerevisiae), in stool: 1) correlates~     with increased gastrointestinal symptoms; 2) correlates with evidence of increased behavioral~     problems (as assessed by the Aberrant Behavior Checklist or Social Responsiveness Scale-2);~     or 3) plays the same role as a constituent of commensal gut microflora as in normal controls.~     The scale indicates severity of social deficits in the autism spectrum as mild, moderate or~     severe. Additionally, the study aims to compare the fecal and oral fungi in these children~     because many fecal mycobiota are felt to originate in the oropharynx.~   "
5561|NCT03494075|"~     The MyPaTH Story Booth will use an (audio) document approach to elicit in depth~     experiential knowledge or perspectives from patients and caregivers by recording their~     personal stories.~   "
5562|NCT03494062|"~     Juvenile Takayasu disease is characterized by chronic inflammation that leads to vascular~     disease. Exercise may render anti-inflammatory effects and protect against cardiovascular~     events. This trial aims to investigate the therapeutic role of exercise in juvenile Takayasu~     disease.~   "
5563|NCT03494049|"~     Postoperative transient stress urine leakage following Holmium laser enucleation of the~     prostate is one of the problems that frustrate both surgeon and patients~      Standard HoLEP might be associated with some stretch of the sphincter and de-epithelization~     of the sphincter area anteriorly.~      In Veil preserving HoLEP, early separation of the adenoma from the sphincter ring minimizes~     sphincter stretch. Furthermore, more proximal incision of the 12 O`clock mucosal strip~     sparring a veil of mucosa covering the sphincter ring.~      Our hypothesis is that by this technique the early postoperative transient urine leak would~     be minimized and duration of leakage if anny would be shortened.~   "
5564|NCT03494036|"~     This is a double blind randomized placebo controlled trial to determine the effect of~     synbiotic to FOXP3 regulatory T cells, IL-17, gut permeability and gut microbiota in patients~     with connective tissue disease. Synbiotic can increase FOXP3 regulatory T cells, decrease~     IL-17 and improve gut permeability and gut microbiota in patients with connective tissue~     disease.~   "
5565|NCT03494023|"~     The main objective of the study is to evaluate the size of the common bile duct (CBD) in a~     large cohort of patients with jaundice secondary to pancreatic head or distal bile duct~     malignancy undergoing diagnostic EUS for tissue acquisition or evaluation of resectability~     and to establish factors associated with a dilation of the CBD greater than 15mm.~   "
5566|NCT03494010|"~     The investigators' primary aim is to determine the impact of using hybrid closed-loop (HCL)~     system in patients with type 1 diabetes (T1D) and end stage renal disease (ESRD) prior to~     kidney transplantation.~      The investigators will also determine whether HCL, by improving glucose control, will affect~     short-term (1 month) and long-term (12 months) complications after kidney transplantation in~     patients with T1D.~   "
5567|NCT03493997|"~     The study is randomized and it will be conducted in the field of routine clinical practice. A~     total of 100 consecutive patients planned to receive radiotherapy for prostate cancer will be~     enrolled.~      The patients will enter the study as controls (50 patients that won't receive any~     experimental IMP) or as treated-group (50 patients that will be also treated with the~     experimental IMPs, Ialuril® and Ialuril® Soft Gels) according to a predefined,~     centre-specific randomization.~   "
5568|NCT03493984|"~     The purpose of this study is to see if substances contained in ginger or aloe plants, called~     exosomes, will treat and improve the condition polycystic ovary syndrome~   "
5577|NCT03493867|"~     The purpose of this study is the verification of Cloud-DX Vitaliti™ Continuous Automated~     Non-Invasive Blood Pressure Monitor for Clinical Use and Self Measurement according to~     standards laid out by IEEE Std 1708 and AAMI-ISO 81060-2.~   "
5580|NCT03493828|"~     TAP Block done with 2 different concentrations of bupivacaine and placebo~   "
5569|NCT03493971|"~     Carotid revascularization procedures are performed for more than 87% of cases in patients~     with asymptomatic internal carotid stenosis (ICS), who are assumed to have a life expectancy~     of at least 5 years. Hence, the investigators aim to compare carotid artery stenting (CAS)~     with carotid endarterectomy (CEA) in terms of long-term prognostic endpoints in patients with~     uneventful perioperative course. CEA and CAS, as a consequence of either surgical trauma or~     mechanical stimuli related to the compliance mismatch between the stented segment and the~     native artery, may perturb carotid baroreceptors function causing an impairment of~     cardiovascular autonomic control. Also, CEA and CAS result in different postoperative~     geometric features of carotid arteries that entail relevant modifications of rheological~     parameters, that may be associated with the risk of local complications. Finally, long-term~     and sustained cognitive benefits after CAS as compared to CEA are yet to be demonstrated.~   "
5570|NCT03493958|"~     Background:~      Many people with alcohol use disorders have a sleep problem called insomnia. One treatment is~     Cognitive Behavioral Therapy for Insomnia (CBT-I). Researchers want to study people s~     experiences with a web-based CBT-I program called SHUTi.~      Objective:~      To test if a web-based insomnia therapy program works well and helps people with alcohol use~     disorders.~      Eligibility:~      Adults ages 18-65 who joined another protocol and have been an inpatient on that protocol at~     least 14 days.~      Design:~      Participants will be screened with questions about insomnia. They will wear a device on their~     wrist and finger for one night while sleeping. This checks for sleep apnea.~      Participants will complete 1 of 2 programs:~        1. SHUTi: Participants will start using the program in the hospital and finish it about 6~          weeks later. They will get a computer tablet to access SHUTi at least 3 times a week.~          They will get surveys, stories, videos, and interactive data about sleep. They will~          complete at least 5 daily sleep diaries every week. SHUTi will be customized based on~          the diaries.~        2. Education-only program: This is like SHUTi but it is not interactive and is not~          customized. Participants will access it at least once a week. They will finish at their~          own pace within 6 weeks. These participants may access SHUTi later.~      All participants will wear a device on their wrist for 4 straight days at several different~     time points. It records activity and sleep data. They will do this 3 times.~      Participants will answer questions about the program before starting it and after finishing.~     Interviews will be audio recorded.~      Participants will do follow-up surveys 6-7 months after they are discharged from the~     hospital.~   "
5571|NCT03493945|"~     Background:~        -  PD-1/PD-L1 signaling appears to be a major inhibitor of activated T cell anti-tumor~          immune responses. The rapid, deep and durable responses seen in various malignancies~          with PD-1/PD-L1 targeted agents demonstrate that blockade of this axis is key to~          facilitating immune responses within the tumor microenvironment (TME).~        -  Prostate cancer is poorly recognized by T cells. Lack of an immune response is one~          explanation for the lower response rates (<15%) observed with anti-PD-1/PD-L1 therapies~          for prostate cancer.~        -  Increasing response rates will likely require therapeutic nullification of multiple~          immune deficits by combining immunotherapies that generate tumor-specific T cells~          (vaccine), dampen the inhibitory milieu of the TME, and enhance T and NK cell activity~          within the TME.~        -  A quick efficacy seeking trial, utilizing sequential arms offers a means to identify~          signals of activity for combinations of immunotherapy, added sequentially, in metastatic~          castrate resistant prostate cancer (mCRPC) patients.~        -  BN-Brachyury is a novel recombinant vector-based therapeutic cancer vaccine designed to~          induce an enhanced immune response against brachyury, which is overexpressed in many~          solid tumor types, including prostate adenocarcinoma. BN-Brachyury collectively refers~          to the priming doses (MVA-BN-Brachyury) and the boost doses (FPV-Brachyury) of the~          vaccine platform.~        -  M7824 is a bifunctional fusion protein consisting of an anti-programmed death ligand 1~          (PD-L1) antibody and the extracellular domain of transforming growth factor beta (TGF-~          beta) receptor type 2, a TGF-beta trap. M7824 can also mediate antibody-dependent~          cellular cytotoxicity in vitro.~        -  ALT-803 is an IL-15/IL-15R alpha superagonist complex that can enhance NK cell mediated~          ADCC and T-cell cytotoxicity.~        -  Synergistic anti-tumor effects have been observed in vitro when combining M7824 and~          ALT-803, and in vivo when combining these agents with tumor vaccine in animal models.~        -  IDO1 is overexpressed in many solid tumors and can contribute to immune escape by tumor~          cells. INCB024360 (Epacadostat) is an IDO1 inhibitor under investigation in combination~          with different immunotherapies in treatment of various malignancies.~        -  In treating of mCRPC, we hypothesize that these agents and their effects will be~          complementary. Tumor-specific T cells generated by vaccine may become more functional in~          a TME following treatment with M7824 and Epacadostat. ALT-803 can further enhance the~          activity of antigen-specific T cells as well as NK cells.~      Objective:~      -To determine if there is clinical benefit to any of a set of 3 possible treatments for~     patients with mCRPC:~        -  BN-Brachyury + M7824~        -  BN-Brachyury + M7824 + ALT-803~        -  BN-Brachyury + M7824 + ALT-803 + Epacadostat~      Eligibility:~        -  Adults with histologically proven mCRPC, or metastatic solid tumor of any type for which~          there is no standard treatment or standard treatment has failed.~        -  Adequate organ function as defined by liver, kidney, and hematologic laboratory testing.~        -  Patients with acquired immune defects, active systemic autoimmune disease, history of~          organ transplant, history of chronic infections, or history of active inflammatory bowel~          disease are excluded.~      Design:~        -  Open label Phase I/II trial with following randomization during the expansion. Phase I:~          Cohort 1, Arm 1.1~           --Up to 18 patients with any solid tumor will be enrolled in dose escalation Cohort 1~          for treatment in Arm 1.1 (flat dose of M7824 + different dose levels of ALT-803).~        -  Phase IIA: expansion with sequential enrollment into Cohort 2, Arms 2.1, 2.2. and 2.3~             -  Concurrently with the enrollment to Arm 1.1, 13 patients with mCRPC will start~               enrollment in Cohort 2 for treatment in Arm 2.1 (M7824 + BN-Brachyury).~             -  When safe dosing of ALT-803 is identified during Phase I, 13 patients have enrolled~               in arm 2.1 and the first 6 patients, treated in Arm 2.1, have met safety~               requirements, 13 patients with mCRPC will start enrollment in Cohort 2 for~               treatment in Arm 2.2 (M7824 + BN-Brachyury + ALT-803).~             -  When 13 patients have enrolled in Arm 2.2 and the first 6 patients, treated in Arm~               2.2, have met safety requirements, 13 patients with mCRPC will start enrollment in~               Cohort 2 for treatment in Arm 2.3 (M7824 + BN-Brachyury + ALT-803 + Epacadostat).~        -  Phase IIB: expansion with randomized enrollment into Cohort 2, Arms 2.1, 2.2. and 2.3~             -  Each Arm in Cohort 2: 2.1, 2.2 and 2.3 will be open for additional enrollment (25~               evaluable patients total) when the initial 13 patients have accrued, safety~               requirements are meet and a positive signal (defined as Objective Response by~               RECIST 1.1 or sustained PSA decrease greater than or equal to 30% sustained for >~               21 days) in greater than or equal to 2 patients is shown.~             -  If only one arm i...~   "
5572|NCT03493932|"~     Background:~      Glioblastoma (GBM) brain tumors almost always return after treatment. When that happens the~     tumor can never completely be removed by surgery, so most people also receive drugs.~     Researchers want to see if combining the drugs nivolumab and BMS-986016 may help.~      Objectives:~      To study how nivolumab affects the brain s immune system in people who have had glioblastoma~     brain tumors return. To study how nivolumab and BMS-986016 affect brain tumors.~      Eligibility:~      Adults age 22 and older who have had a return of GBM~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Cheek swab~      Heart, blood and urine tests~      Chest x-ray~      Magnetic resonance imaging (MRI) brain scan. Participants will lie on a table that slides in~     and out of a cylinder in a strong magnetic field. A contrast agent will be injected in an arm~     vein.~      Participants will stay in the hospital. They will:~      Have surgery. A tube will be inserted into the back. Brain tumor and bone marrow samples will~     be taken. Tubes will be inserted into the brain.~      Have a computed tomography brain scan.~      Stay in Intensive Care (ICU) 7 days. Fluid from the brain and back will be collected every~     few hours. In the ICU, participants will get nivolumab by IV for 30 minutes.~      Have surgery to remove the tubes.~      Have standard surgery to remove as much of the GBM as possible. Bone marrow will be removed.~      After leaving the hospital, participants will have visits every 2 weeks to get the study~     drugs by IV and have physical exams and blood tests.~      Participants will have a brain MRI once a month.~   "
5573|NCT03493919|"~     The purpose of this study is to collect large volumes of matched pairs of pre- and~     post-vaccination sera from healthy subjects who will be administered GlaxoSmithKline (GSK)~     Biologicals' vaccine against meningitis- MenACWY vaccine (Menveo) or rMenB+OMV NZ vaccine~     (Bexsero), which will serve for the development, qualification, validation and maintenance of~     immunological assays and will support the preclinical research activities and clinical~     development of GSK Biologicals' vaccines. The safety of the subjects given one of the 2~     vaccines (Bexsero or Menveo), as per the recommended dosage and schedule will be assessed~     during their participation in the study.~   "
5574|NCT03493906|"~     Background: Acute leukemia is a life threatening hematological malignancy which can result in~     substantial symptom burden including impaired psychological wellbeing. Peer-to-peer support~     has positive and beneficial effects on patients with cancer. Yet there is lack of knowledge~     and evidence of the feasibility and the effect of peer-to-peer support on patient with acute~     leukemia~      Aims: The study aim to examine the feasibility and safety of Patient Ambassador Support in~     newly diagnosed patients with acute leukemia during treatment, and to examine the benefit on~     symptoms and psychological wellbeing in both patients and ambassadors.~      Design and methods: This study is a one arm feasibility intervention trial with patients~     n=40; patient ambassadors (PA) n=30. Patients will be consecutively recruited at the~     Departments of Hematology, Rigshospitalet, Herlev and Gentofte Hospital and Sjællands~     Universitetshospital, Roskilde, and paired with a PA who will follow and assist the patient~     over the course of two series of chemotherapy for a 12 week period, with one follow-up~     contact at 3 month. Data is collected at baseline (within 2 weeks of diagnosis), post~     intervention (12 weeks) and follow-up 6 months.~      Implication: This study has the potential to be a new model for care incorporated in the~     oncology/hematology clinical care setting, creating an active partnership between patients~     and former patients; and in collaboration with the health care professionals which may~     strengthen the existing care and support system.~   "
5575|NCT03493893|"~     The aim of this study was to investigate the clinical effects of design changes from the use~     of three different IM nail designs in the management of extracapsular hip fractures.~   "
5581|NCT03493815|"~     To determine the utility of ultrasound guided IUD insertion compared to the traditional blind~     insertion at an academic health institute where the skill level of the provider can vary~     greatly. We hypothesize that ultrasound-guided insertion will lead lower IUD discontinuation~     rates and greater patient satisfaction.~   "
5583|NCT03493789|"~     This trial studies how well fludeoxyglucose F-18 - positron emission tomography (PET) works~     in planning radiation therapy in participants with early non-small cell lung cancer, early~     stage lung cancer, or cancer that has spread to lungs from other parts of the body. Using PET~     in addition to the standard computed tomography to plan radiation therapy for cancer may help~     doctors to maximize the dose to the cancer and minimize the dose to normal tissues.~   "
5584|NCT03493776|"~     The investigators plan to study the immunogenicity of the vaccine before and after lung~     transplantation. Patients (at least 50 years old) before and after lung transplantation will~     be enrolled. The investigators hypothesize that the recombinant varicella-zoster subunit~     vaccine is able to induce cellular immunogenicity after transplantation.~   "
5585|NCT03493763|"~     In this study, investigators aim to find out how plasma 5hmC level changes in hepatocellular~     carcinoma patients after liver resection, and determine whether 5hmC can be used as a~     biomarker for HCC recurrence monitoring.~   "
5586|NCT03493750|"~     Oral health is defined as the state of being free from dental or periodontal diseases and~     discomfort of oral cavity. WHO considers that oral hygiene is a major public health problem~     whatever the countries (developed, developing, and underdeveloped).~      The two main local medical problems are dental caries and periodontal diseases. Without~     appropriate treatments, both diseases can lead to local functional and esthetic damages, and~     can also have some negative repercussions on health.~      Studies showed that there are great social disparities among people concerned by oral health~     issues. People in vulnerable situations (homeless and low incomes people, refugees) had less~     recourse to dental care. Those who consult do it less often and later. Reasons are mainly~     cost related, but also people in vulnerable situation don't perceive dental care as an~     important matter and don't know where and how to ask for help for having dental care.~      PASS (french acronym for Office of Access to Healthcare) departments, setting in both~     private and public health institutions, are intended to facilitate the access to care and the~     support of people in vulnerable situations, and their accompaniment in the steps necessary~     for the recognition of their rights.~      Nurses of the Annecy PASS department had developed a questionnaire called healthplan guide~     that aim at helping them to screen and identify people with dental diseases among those in~     vulnerable situation, and to sensitize them about the importance of oral hygiene and how to~     improve it. This questionnaire is use in daily practice.~      This study hypothesizes that more patients will be sensitized to benefit a dental examination~     in a dental practice if nurses use the healthplan guide questionnaire combined with an oral~     and dental evaluation.~   "
5587|NCT03493737|"~     Bortezomib needs repetitive visits at hospital for injections. Hospital-at-Home (HaH) might~     be an attractive and suitable alternative in this situation.~      This study aim to perform a cost-utility analysis of two different strategies in several HaH~     structures within the Grand Est region in France.~   "
5588|NCT03493724|"~     To study the diagnostic performance of the images on the smartphone compare the result of the~     clinical examination, all the dermatoses combined and by family of pathology (inflammatory,~     wound, oncology, infectious, allergology), during urgent request requests in dermatology~   "
5589|NCT03493711|"~     This study will help us learn how a child's diet affects growth and development.~   "
5590|NCT03493698|"~     This is a single center, open-label, fixed sequence study to investigate the effect of~     multiple oral dosing of Inarigivir Soproxil and a single oral dose of Midazolam in Healthy~     Subjects~   "
5591|NCT03493685|"~     To determine the long-term nephroprotective potential of treatment with sparsentan as~     compared to an angiotensin receptor blocker in patients with primary focal segmental~     glomerulosclerosis (FSGS).~   "
5592|NCT03493672|"~     Rationale:~      Optimal selection of patients with cancer eligible for a clinical trial, is of utmost~     importance, but can be very difficult. Patients must be sufficiently fit and have a~     reasonable life expectancy, to be eligible for participation in clinical trials. In current~     clinical practice, the ECOG/WHO performance status, is used to select patients for clinical~     trials, and it has proven to be an independent predictor of survival in patients with cancer.~     This score is based on a subjective assessment of the treating physician, which can, together~     with the strong motivation of some patients to participate, lead to overestimation of a~     patient's actual physical condition and may thereby contribute to early trial~     discontinuation. Participation of these patients may not only harm them, but will also hamper~     trial conduct and outcomes.~      Both, physical activity and fitness are positively associated with survival in patients with~     cancer. This gives rise to the investigators hypothesis that objective measurements can be of~     added value in the selection process. Additionally, preliminary results in 50 patients with~     cancer that participated in part 1 of the Counting Steps! project revealed that the~     smartphone can produce valid and reliable assessments of physical activity and fitness, and~     the user friendliness was rated good by patients.~      The investigators hypothesize that measurements of physical activity and fitness with~     smartphones will provide more objective and accurate information about the actual physical~     condition of a patient with cancer.~      With a better prediction of trial feasibility (without early trial discontinuation) and~     overall survival in patients participating in phase I-II clinical trials, the selection of~     eligible trial participants could be improved. In this way, it is possible to more adequately~     identify patients who are most likely to successfully participate in a clinical trial and~     thereby have the highest chance to benefit from trial participation. Successful trial~     participation will provide optimal palliative care to patients and improve their quality of~     life. In addition, it may prohibit participation of patients who are currently incorrectly~     included in clinical trials and suffer from toxic therapies without having a chance to~     benefit from treatment. A better selection of patients will be beneficial for the trial~     outcomes and subsequently for the development of new anticancer drugs or treatment regimens.~      Objective:~      The investigators aim to:~        1. Identify whether objective smartphone measurements of physical activity and fitness is~          predictive for trial feasibility (without early trial discontinuation) in patients with~          cancer participating in phase I-II clinical trials.~        2. Evaluate the feasibility and acceptability of the use of the smartphone's objective~          assessments of physical activity and fitness in clinical practice.~      Study design: Observational study~      Study population:~      • 135 patients with hematologic or solid cancer referred to the VU medical center for~     participation in phase I-II clinical trials.~      Intervention:~      In this observational study, patients will not receive an additional intervention.~      Main study parameters/endpoints:~      Prior to the start of medical treatment, physicians will rate the performance status, and~     participants will wear a smartphone for one week to measure the daily number of steps, to~     complete the 6 minute walk test using the smartphone application, and to fill out the 5-item~     physical function subscale of the EORTC QLQ-C30. These assessments will be repeated after 4~     and 8 weeks.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness:~      No extra visits to the hospital will be necessary. Participation in this study will not cause~     any additional risks or expected benefits for participants. It will only deliver knowledge,~     which may be used in the future to better select patients eligible for participation in phase~     I-II clinical trials or even for regular treatment. Participation in the study will only cost~     time for patients. The patients will be asked to wear a smartphone for a week, have to~     perform a six-minute walk test (6MWT) once in this week and have to complete a questionnaire~     about their own physical function once. Subsequently, patients will repeat those measurements~     4 and 8 weeks after inclusion in the phase I-II clinical trial.~   "
5593|NCT03493659|"~     Problem-based learning (PBL) is an education model utilized by Maastricht University and many~     other universities worldwide. PBL occurs in small, collaborative tutorials, under the~     facilitation of a tutor. This study explores the effects of standing tutorials, compared~     against sitting tutorials, on PBL among undergraduate students. A quantitative approach will~     be taken to objectively measure students' learning, and a qualitative approach will be taken~     to obtain a deeper understanding of the processes of learning.~      It is hypothesized that students in the standing tutorials will be able to recall more~     academic concepts and link the concepts better than students in the sitting tutorials (H1).~     Audio-recording of the tutorials will be used to measure the discussions within the~     tutorials. The transcriptions obtained from the recording will be studied through text~     analysis. It is hypothesized that students in the standing tutorials will produce more~     discussions, and therefore a higher word count (H2). It is also hypothesized that the~     students in the standing tutorials will use more word categories that are conducive to the~     discussion and learning process (H3).~      Through the qualitative approach, the content of the transcriptions will be analysed through~     a thematic analysis. It is hypothesized that the students in the standing tutorials will~     produce more learning-oriented interactions (H4).~      Two additional factors that would be measured are subsequent physical activity and academic~     achievement. ActivPAL accelerometers will be used to measure the students' daily activity, to~     find out if the students' daily activities are affected by the standing tutorials, for~     example, students may sit more as a result of fatigue from the standing tutorials, or~     conversely transfer the active behaviour from the standing tutorials to other activities~     outside the tutorial group.It is hypothesized that standing tutorials do not affect the~     students' subsequent physical activity, and therefore there will be no significant~     differences of daily activity between students in the sitting and standing tutorials (H5).~     With regards to academic achievement, it is hypothesized that the students in the standing~     tutorials will have higher academic achievements after the course compared to the students in~     the sitting tutorials (H6).~   "
5594|NCT03493646|"~     Myelodysplastic Syndrome (MDS) is a group of blood disorders where the bone marrow does not~     produce enough mature red blood cells, white blood cells and platelets. In a healthy person,~     the bone marrow makes blood stem cells (immature cells, also called 'blasts') that become~     mature blood cells over time. In people with MDS, this process is affected and immature blood~     cells in the bone marrow do not mature fully to become healthy blood cells. This causes a~     lack of healthy blood cells that can function properly. With fewer healthy blood cells,~     infection, anaemia, or easy bleeding may occur. MDS can progress to acute myeloid leukaemia~     in 25-30% of patients, and if untreated it can be rapidly fatal.~      The purpose of this study is to evaluate the standard treatment, azacitidine (Vidaza) given~     as an injection under the skin compared to the same medication (called CC-486) taken as a~     tablet by mouth. Vidaza is approved by the Australian Therapeutics Goods Administration (TGA)~     as standard treatment for MDS. CC-486 is an experimental treatment. This means it is not an~     approved treatment for MDS in Australia. CC-486 is being developed to increase convenience~     and make it easier for patients to continue their treatment. So far it has been given to over~     870 patients in studies across the world. The treatment in the injection and the tablet is~     the same. Studies like this one are being done to ensure the tablet works in the same way as~     the standard injected treatment.~      Vidaza is given by subcutaneous injection (ie under the skin) over an hour for 7 days every 4~     weeks for as long as it continues to work. All study participants will receive active~     treatment (there is no placebo), and all participants will receive the standard injection for~     six treatment cycles followed by the new tablet medication taken once daily for 21 days every~     4 weeks. This allows the researchers to compare the two ways of giving the medicine.~   "
5595|NCT03493633|"~     Our research hypothesis is that the practice of walking on a secure treadmill is possible at~     home and allows the patient to increase the training work of walking in everyday life~     compared to a conventional care.~   "
5721|NCT03491982|"~     This study evaluates the compliance of patients in a Phase 2 (outpatient clinic based)~     cardiac rehabilitation program, who are offered the opportunity to perform the rehab remotely~     (e.g. at home, not at the clinic), using a remote monitor and smart-phone application.~   "
5596|NCT03493620|"~     Obesity is a chronic disease that has grown to epidemic proportions in Brazil and throughout~     the world in recent years. Bariatric surgery has been the most effective method for the~     treatment and prophylaxis of complications caused by morbid obesity, thereby increasing the~     longevity and quality of life of patients. The treatment of patients with Class III obesity~     or higher or Class II with comorbidities is already well established with bariatric surgery~     being the best option. However, there is no consensus as to the best treatment in cases of~     Class I or II obesity without comorbidities. The objective of this research will be to make a~     gastric tube similar to that obtained by surgical gastroplication but using endoscopic~     intragastric sutures.~   "
5597|NCT03493607|"~     The purpose of this study is to investigate the safety, tolerability and efficacy of a single~     6-hour intravenous infusion of AMO-01 to treat adolescents and adults with PMS and co-morbid~     epilepsy. Phelan-McDermid Syndrome (PMS) is a neurodevelopmental disorder characterized by a~     chromosomal deletion or mutation at 22q13.3 that contains the SHANK3/ProSAP2 gene. A key~     co-morbidity in PMS is the presence of epilepsy. Currently there are no approved treatments~     for PMS. Furthermore, there has been relatively little clinical study of pharmacological~     interventions for PMS. AMO-01 may provide benefit to PMS patients exhibiting behavioral~     abnormalities and seizures.~   "
5598|NCT03493594|"~     Effective early life programs that reduce the long-term non-communicable diseases (NCDs) risk~     could bring great economic benefits to the society. However, there is a lack of local data on~     the effect of nutrition on child growth and most research on early life intervention focus on~     disease models such as obese women to improve offspring health outcomes. There is limited~     research on postpartum interventions in the community that optimize maternal and infant~     nutrition through improving success of breastfeeding, infant growth diet quality and~     microbiota to enhance health in the adulthood.~      In this study, it is hypothesized that our early nutrition program could promote~     breastfeeding successful rate (increase the number of months the mothers breastfed their~     infants) and improve growth status, diet quality and microbiota of the infants which may~     reduce the risk of NCDs in the adulthood. The planned project proposal would like to include~     240 pairs of mothers and infants. In order to test the protocol in the planned proposal, the~     investigators hope to run a pilot study to set up this community based early nutrition~     program including breastfeeding workshops and supports, healthy lifestyle courses, parenting~     education, introduction of solid foods for infants, child development and cooking classes of~     infant foods. the investigators will evaluate the effectiveness of this early nutrition~     program and determine its impacts on breastfeeding, infant growth (by comparing infants'~     biomarkers and microbiota in different stages) , diet quality and microbiota, as well as the~     benefits to the postpartum mothers such as reducing the postpartum weight retention so that~     to generate pilot result and facilitate the up scale study that the investigators proposed in~     the planned proposal.~      The ultimate goal is that a long term follow up with the children in this project could also~     be arranged to determine the long term health effects of this early nutrition program.~   "
5599|NCT03493581|"~     PIONeeR study is a prospective, multicenter study without administration of an~     investigational product.~      The promotion and funding will be done by the Assistance Publique Hôpitaux de Marseille~     (APHM), the coordination by AMU. There will be 3 principal investigational clinical centres~     in France:~        -  Centre d'Essais Précoces en Cancérologie de Marseille (CEPCM)-Unité de Phase I Oncologie~          labélisée CLIP² in APHM, Marseille, supervised by Prof. F. Barlesi~        -  Medical Oncology Department of Centre Léon Bérard, Lyon, supervised by Prof. M. Pérol~        -  Unité d'Oncologie Thoracique, CHU Larrey /Oncopôle, Toulouse, supervised by Prof. J.~          Mazières.~      Some secondary centres, nearby the three principal mentioned above, will be associated to~     ensure recruitment of patients, in accordance to provisional planning.~        -  The primary objective is to validate the existence and distribution of the hypothetical~          immune profile (within blood and tumoral tissue) explaining primary or adaptive~          resistance to standard PD-1 inhibitors monotherapy, in NSCLC patients.~        -  The secondary objectives are to better characterize :~             -  PK/PD relationships,~             -  inter-patient PK variability,~             -  If systemic exposure levels could be predictive of efficacy of PD-1 ICI, in NSCLC~               patients.~        -  Some exploratory objectives are :~             -  to assess a predictive value of a panel of endothelial biomarkers, in NSCLC~               patients.~             -  to compare predictive immune & endothelial biomarker profiles with those of~               sensitive tumors.~             -  to better understand which profiles track significantly with progression following~               PD-1 ICI administration, in order to improve advanced NSCLC patients'~               stratification, for future clinical trials.~   "
5600|NCT03493568|"~     Research hypothesis:~      Switching from dual regimens based on dolutegravir plus a RTI to a single tablet regimen of~     elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF), lowers the exposure~     to Residual Viremia (and hence the risk of viral rebound), without increasing treatment~     toxicity.~   "
5601|NCT03493555|"~     The specific aims of this study are:~        1. To explore perceived facilitators and barriers to initiating and adhering to HIV~          PRE-EXPOSURE PROPHYLAXIS (PrEP) among at-risk YOUNG MEN WHO HAVE SEX WITH MEN (YMSM).~        2. To assess the acceptability and feasibility of a culturally-tailored peer navigator~          program to optimize adherence to PrEP among YMSM.~   "
5602|NCT03493542|"~     This study is designed to evaluate the immunogenicity, safety, and tolerability of Gardasil™~     (quadrivalent human papillomavirus [qHPV] vaccine, V501) in Chinese girls aged 9-19 years and~     young women aged 20-26 years. The primary hypothesis of the study states that a 3-dose~     regimen of V501 induces non-inferior geometric mean titers (GMTs) for serum anti-HPV 6,~     anti-HPV 11, anti-HPV 16, anti-HPV 18 in girls aged 9-19 years compared to young women aged~     20-26 years.~   "
5603|NCT03493529|"~     The objective of this project is the identification and quantification of the main bacterial~     communities present in the endometrial microbiota in obese infertile patients, to assess if~     there is an alteration of their composition dependent on the body mass index, and if such~     alteration it could influence the reduction of endometrial receptivity, demonstrated in obese~     women. If obese patients have an altered digestive microbiota and, at the same time, a lower~     endometrial receptivity, the investigator want to assess whether such reduction in~     receptivity may depend on an alteration in the endometrial microbiota, which in non-obese~     infertile patients has been shown to negatively influence the reproductive results~   "
5604|NCT03493516|"~     Sudden cardiac death continues to be a major contributor to mortality in patients with~     ischemic cardiomyopathy. While implantable defibrillators can prevent death from ventricular~     arrhythmias, our current approach to identify patients at highest risk primarily rests on~     demonstrating a reduction in left ventricular ejection fraction less than 35%. The purpose of~     this observational cohort study is to prospectively test whether this can be enhanced by~     quantifying the amount of sympathetic denervation, left ventricular end-diastolic volume or~     brain natriuretic peptide levels.~   "
5605|NCT03493503|"~     Although IV salbutamol is frequently used in children in a wide range, pharmacodynamic data~     are scarce. To date, there is an insufficient evidence base to guide initial and subsequent~     dosing recommendation for its IV use in children. Especially the need for a loading dose~     needs to be addressed. Therefore, pharmacodynamic and kinetic data are needed to guide~     initial dosing strategies of IV salbutamol in children. To assess the efficacy of a loading~     dose of intravenous salbutamol in children admitted to a PICU for severe acute wheeze or~     severe acute asthma. Efficacy is measured by the reduction in asthma score (Qureshi) at 1~     hour after administration of the loading dose, compared to placebo.~   "
5606|NCT03493490|"~     The clinical study is planned as a double-blind, randomised, placebo-controlled,~     parallel-group, single-centre exploratory clinical study with the aim to investigate the~     analgesic efficacy of the Neodolpasse® Infusion Solution in comparison to a 75 mg diclofenac~     only infusion. Included will be Patients receiving elective cruciate ligament surgery. The~     effectiveness will be measured by the use of additional analgesic medication via PCA during~     the first 24 hours postoperatively as well as by using a Visual Analogue Scale (VAS).~     Furthermore the local and systemic tolerability and safety of the clinical study medications~     (i.e. Neodolpasse® Infusion Solution and 75 mg diclofenac only infusion) will be assessed.~   "
5607|NCT03493477|"~     The aim of this study is to evaluate gingival biotypes and width of keratinized gingiva in~     the anterior region of adults with abnormal skeletal jaw relations.~   "
5608|NCT03493464|"~     This is an exploratory phase II, single center, open label, prospective study of BR55 CEUS~     for characterization of ovarian lesions in subjects with suspected ovarian cancer.~   "
5609|NCT03493451|"~     This is a multi-center, prospective, non-randomized, open-label, Phase 2 clinical study to~     evaluate the safety and efficacy of BGB-A317 in patients with relapsed or refractory mature~     T- and natural killer (NK)-cell neoplasms. There will be two cohorts of patients:~        -  Cohort 1: Patients with relapsed or refractory extranodal NK/T cell lymphoma (nasal or~          non-nasal type)~        -  Cohort 2: Patients with other mature T-cell neoplasms, limited to the following~          histologies; peripheral T-cell lymphoma- not otherwise specified (NOS),~          angioimmunoblastic T-cell lymphoma, and anaplastic large cell lymphoma.~      Approximately 50 patients will be enrolled into Cohort 1 and 40 patients into Cohort 2 for a~     total sample size of 90 patients. Cohort 2 will include 20 patients with EBV-positive disease~     and 20 patients with EBV-negative disease. The primary efficacy endpoint is ORR determined by~     independent central review. Disease response for the primary endpoint will be assessed per~     the Lugano criteria with the LYRIC modification for immunomodulatory therapy BGB-A317 will be~     administered intravenously as a 200 mg infusion every 3 weeks (Each cycle consists of 21~     days). Study procedures will occur over a Screening phase (up to 35 days); Treatment phase~     (until disease progression, intolerable toxicity, or withdrawal of informed consent,~     whichever occurs first); Safety Follow-up phase (up to 90 days following last study treatment~     for all AEs and SAEs); Survival follow-up phase (duration varying by patient).~   "
5610|NCT03493438|"~     Low back pain is an extremely common health problem that most people suffers at any point in~     their life. Low back pain is the leading cause of activity limitation and work absence~     throughout much of the world and it causes some economic problems for just not only~     individuals but also governments. ) The purpose of the study was to investigate the effects~     of different physical therapy techniques on pain, function and core stability in patients~     with low back pain.~   "
5611|NCT03493425|"~     This randomized phase II trial studies how well chemotherapy before surgery and radiation~     therapy works compared to surgery and radiation therapy alone in treating patients with nasal~     and paranasal sinus cancer that can be removed by surgery. Drugs used in chemotherapy, such~     as docetaxel, cisplatin, and carboplatin work in different ways to stop the growth of tumor~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors.~     Giving chemotherapy before surgery and radiation therapy may make the tumor smaller and~     reduce the amount of normal tissue that needs to be removed and treated with radiation.~   "
5612|NCT03493412|"~     Nitric oxide has been shown to be an important regulator within the cardiovascular system,~     responsible for regulation of blood flow, blood pressure and vascular growth. Cardiovascular~     diseases show a reduced ability of the peripheral blood vessels to dilate due to decreased~     levels of NO with concomitant increased levels of oxidative stress, which is extremely~     detrimental to patients with PAD, as the limited oxygen delivery to skeletal muscles~     ultimately results in claudication and reduced physical ability. However, this reduced oxygen~     delivery and utilization may be able to be improved as previous studies have revealed that~     tetrahydrobiopterin (BH4), is an important cofactor responsible for NO production.~     Furthermore, recent studies have shown that endothelial BH4 levels are associated with the~     vascular pathophysiological response to hypoxia, as it directly mediates endothelial nitric~     oxide synthase regulation and reduces superoxide production. Additionally, acute~     administration of BH4 was shown to improve vascular function, specifically, endothelial~     mediated vasodilatory function, in patients with systemic vascular and coronary disease, as~     well as six minute walking distances in patients with hypertension. Therefore, the purpose of~     this proposed study will be to examine the effects of BH4 on vascular function, oxidative~     stress and leg performance in patients with PAD. This study will examine patients with a~     classification of stage 1 or stage 2 peripheral artery disease who demonstrate a history of~     exercise-limiting claudication. Blood vessel oxygen transfer capacity in the leg will be~     assessed in the femoral and popliteal arteries with ultrasound, and blood vessel dilatory~     ability will be assessed in the brachial artery with flow-mediated dilation. Skeletal muscle~     mitochondrial function will be measured with near infrared spectroscopy, and ROS levels will~     be analyzed through blood samples. Leg function will be measured with an isokinetic~     dynamometer.~   "
5613|NCT03493399|"~     Gambling craving is involved in the development, maintenance and relapse of gambling disorder~     (e.g., Young & Wohl, 2009). Yet, it lacks research regarding evidence-based interventions~     available to mitigate craving in patients displaying gambling disorder. The elaborated~     intrusion theory of desire (EIT; Kavanagh, Andrade, & May, 2005) is a cognitive model of~     craving which offers important avenues for the development of psychological interventions, as~     it clearly describes the processes at play in craving experiences (e.g., mental imageries,~     working memory). Recently, Cornil et al. (2018) evidenced that the elaborated intrusion~     theory is relevant to account for gambling craving experiences. According to this model,~     craving (and desire) is the result of an elaboration process where desires thoughts (mental~     images and thoughts), induced by internal (e.g., frustration) and/or external (e.g.,~     advertisement) triggers, require attentional and cognitive resources. The principle of~     interference-based techniques is to move the resources allocated to the elaboration of~     intrusive desire thoughts to a competing task (e.g., clay modelling, competitive mental~     imagery, Tetris) in order to monopolize the resources underlying craving, thus preventing its~     elaboration and reducing its vividness and overwhelming nature. Several studies (Andrade,~     Pears, May, & Kavanagh, 2012; May, Andrade, Panabokke, & Kavanagh, 2010; Skorka-Brown,~     Andrade, Whalley, & May, 2015) have shown the efficacy of such techniques to reduce~     substance-related craving. Yet, data obtained on clinical samples remain scarce.~      Preliminary data have been obtained prior to this application. In order to investigate the~     relevance of interference-based techniques, an experimental study (Cornil & Billieux, 2017)~     was conducted in community gamblers. In two conditions (19 gamblers per condition), gambling~     craving was first induced via a short mental imagery session and a computer-generated~     gambling simulation task. Then, the experimental group was asked to perform an interference~     task consisting of creating a vivid mental image of a bunch of keys. The control group~     completed a task in which they had to pop and count bubble wrap. The analyses revealed that~     induced craving decreases significantly in both groups. However, participants that are~     considered problem gamblers showed a greater decrease of their craving in the experimental~     condition. This previous proof of principle study supports that interference-based~     techniques are potentially promising interventions to reduce craving in problem gambling. It~     also warrants further research as no data is available in clinical population.~      The current project consists in a pilot study aiming to test the efficacy of~     interference-based techniques in a sample of gambling disorder patients. The investigators~     decided to adopt a multiple single case design, as this methodology is ideal in the sense~     that it helps to understand the whole process of an interference-based intervention among a~     small number (7) of outpatients with a gambling disorder, without control group. In addition~     to be easily implementable in a clinical design, this design will provide sufficient~     evidences before possible, in a second time, further validation of these techniques using a~     randomized-control trial.~   "
5614|NCT03493386|"~     This is two-way crossover study to compare pharmacokinetic (PK) of daprodustat 2 milligram~     (mg) versus 4 mg tablets and food effect on the PK of daprodustat following single oral doses~     in healthy Japanese male subjects. This study will be conducted in two parts. Part 1 is the~     bioequivalence part in which subjects will receive single dose of 2 tablets of 2 mg~     daprodustat and single dose of 1 tablet of 4 mg daprodustat in crossover manner. Part 2 is~     Food effect part. In this part, subjects will receive single dose of 4 mg daprodustat tablet~     in fasting and fed state in a crossover manner. There will 5-day wash-out period between each~     intervention period. There will be approximately 52 subjects in Part 1 and 12 subjects in~     Part 2. The study will last for 6 weeks.~   "
5615|NCT03493373|"~     This study aims to compare the effectiveness of nervous system mobilization and exercise with~     exercise only on institutionalized older adults' postural control.~   "
5616|NCT03493360|"~     The objectives of this study are to:~        -  Evaluate the effect of visual feedback on the intensity of low back pain, range of~          motion and function of pregnant and non-pregnant women with chronic low back pain.~        -  Determine the association between low back pain, catastrophizing, fear of movement and~          low back perception/image.~   "
5633|NCT03493139|"~     The study is designed to compare two methods of delivering short (~10 min) physical activity~     breaks that will occur during the regular school day for 3 years. Schools will be randomized~     to deliver physical activity breaks led by either the regular classroom teacher or by a~     remote instructor through a video in the classroom. Both delivery methods will promote a~     variety of whole body movements using large muscle groups. The schools will not be able to~     choose which group (regular teacher or remote instructor) they will be part of.~   "
5617|NCT03493347|"~     Children with autism spectrum disorders (ASD) often participate in equine-assisted~     interventions, where practitioners partner with horses to improve the health and well-being~     of the clients they serve. One of these interventions is equine-assisted occupational therapy~     (EAOT). The first aim of this study is to assess the effectiveness of EAOT at improving the~     social, behavioral, and occupational functioning of children with ASD. Second, this study~     aims to conceptually develop the theory of change that guides how horses are integrated into~     occupational therapy for children with ASD. Eight children with ASD will participate in 10~     weeks of EAOT. The quantitative strand will involve caregivers filling out measures of social~     functioning, self-regulation, and occupational performance on a weekly basis. Investigators~     hypothesize children will demonstrate improved performance on these measures during the~     intervention in comparison to baseline. The qualitative strand will consist of interviews~     with the providing occupational therapists aimed at understanding the theory behind why the~     intervention is effective. The results of this study will have implications for children with~     ASD, their families, and occupational therapists providing services to individuals with ASD.~   "
5618|NCT03493334|"~     The objective of this study is to evaluate the impact of visual feedback of the posterior~     region of the cervical spine on pain intensity and range of motion.~   "
5619|NCT03493321|"~     this research will evaluate the effect of PRF with different bioactive materials in dentistry~   "
5620|NCT03493308|"~     The primary objectives of this study are to:~        -  Evaluate recruitment procedures and adherence rates;~        -  Evaluate the ability to understand the concepts of pain neurophysiology;~        -  Evaluate the acceptability of an intervention program based on pain neuroscience~          education and exercise by institutionalized older adults and the institutions where they~          are.~   "
5621|NCT03493295|"~     The aim of this non-interventional study (NIS) is to assess, under real-life conditions,~     woman's satisfaction with Levonogestrel IntraUterine System (LNG-IUS) in a young (18-30 years~     old (y.o.)) Spanish population taking into account their parity status.~      Furthermore, the study is aimed to evaluate the impact of: menstrual bleeding pattern and~     satisfaction with it at baseline, LNG-IUS chosen, previously used contraceptive method and~     reasons for change to/ choice of a LNG-IUS on overall satisfaction with LNG-IUS use.~   "
5622|NCT03493282|"~     This is a single-center, randomized, double-blind, placebo-controlled, parallel group study~     of two doses of CT1812 in adults with mild to moderate Alzheimer's Disease to evaluate the~     safety and tolerability of oral CT1812, administered for up 180 days.~   "
5623|NCT03493269|"~     To assess safety and tolerability of multiple oral doses of BAY1834845 in healthy male~     subjects (Part 1) and in patients with RA or psoriasis (Part 2) To assess the pharmacokinetic~     (PK) properties of total BAY 1834845 in plasma after oral multiple doses of BAY1834845 in~     healthy male subjects (Part 1) and patients with RA or psoriasis (Part 2)~   "
5624|NCT03493256|"~     In this single center prospective cohort study a total of 100 patients scheduled for elective~     off-pump CABG will be recruited. They will be allocated to one study and one control group~     according to the presence or absence of postoperative type 2 neurological complications. The~     two groups will be compared in terms of serum concentrations of glial fibrillary acidic~     protein (GFAP), neuroserpin (NSP), phosphorylated axonal neurofilament subunit H (pNfH) and~     visinin-like protein 1 (VILIP-1) at the time of skin incision and closure as well as 24 hours~     and 7 days following surgery. Diagnostic performance of these markers for predicting type 2~     neurological complications of off-pump CABG will be assessed.~   "
5625|NCT03493243|"~     -  Context: Since March 2012, several terrorist attacks have been perpetrated in France~          (Toulouse, Montauban, Paris, Nice ...). In March 2017, 53 french teenagers were victims~          in a terrorist attack in London (Westminster Bridge).~        -  Main goal = to estimate the psycho-traumatic impact and to describe cares and management~          of high school students, victims of the terrorist attack in London on 2017, March the~          22nd.~        -  3 secondary objectives: 1) Clinical (occurrence of Post Traumatic Stress Disorders or~          other disorders); 2) Epidemiological (risk factors for developing disorders, avoiding~          care); 3) Preventive and therapeutic.~   "
5626|NCT03493230|"~     The main objective of this project is to perform a longitudinal monitoring of BRAF and NRAS~     cell-free DNA in a large cohort of metastatic melanomas patients before treatment and during~     the follow-up. Results will be compared with clinical data as imaging (based on RECIST~     criteria) and the activity of lactate dehydrogenase in serum (LDH).~   "
5627|NCT03493217|"~     The phase I/II clinical study is to investigate the safety, tolerability and efficacy of~     ICP-022 in R/R CLL/SLL patients.~   "
5628|NCT03493204|"~     The purpose of this study is to determine the feasibility of a home meal delivery program for~     patients with cirrhosis and ascites and to determine the effectiveness of a salt-restricted~     (2 gram sodium) meal delivery program in reducing the need for therapeutic paracenteses~     and/or all-cause re-admissions for these patients. Many patients with cirrhosis don't have~     enough nutrients in the body and are frail and these meals may help them maintain a good diet~     and lead to improved quality of life.~   "
5629|NCT03493191|"~     This is a randomized, double-blind, placebo-controlled, single ascending-dose study to~     investigate the effect of a single intravenous (IV) dose of SHR0410 at 6 dose levels (0.5~     μg/kg, 1 μg/kg, 2 μg/kg, 5 μg/kg, 10 μg/kg and 20 μg/kg) in healthy participants.~   "
5630|NCT03493178|"~     Elderly humans have an increased risk of dementia which begins as mild defects in memory~     called mild cognitive impairment. Glutathione (GSH), a key endogenous antioxidant has been~     linked to cognition. This exploratory study will investigate mechanisms linked to GSH for~     cognitive impairment (and improvement) by studying humans with mild cognitive impairment who~     will be evaluated 12-weeks after receiving either N-acetylcysteine and glycine (GSH~     precursors), or receiving alanine, and a further 12-weeks after stopping these supplements.~   "
5631|NCT03493165|"~     Single patient treatment with everolimus.~   "
5632|NCT03493152|"~     Single patient treatment with everolimus.~   "
5634|NCT03493126|"~     Pilot randomized, placebo-controlled trial of nulliparous postpartum women with a perineal~     laceration following a term vaginal delivery comparing vulvovaginal atrophy symptoms between~     women using vaginal estrogen in the postpartum period with those using placebo.~   "
5722|NCT03491969|"~     The study will evaluate the efficacy of alpha-lipoic acid(α-LA) on mortality in patients with~     ischemic heart failure (NYHA Class II - IV and EF =< 45%).~   "
5637|NCT03493087|"~     Studies have shown that patients with chronic kidney disease in hemodialysis have a low~     vitamin K status which is believed to be related to an increased risk of atherosclerosis and~     increased bleeding tendency. The underlying causes of low vitamin K status in hemodialysis~     patients is unknown. Thus, the aim of this study is to investigate why hemodialysis patients~     have a low vitamin K status and how to improve it.~      This study is composed of five trials. Four of them are based on possible hypotheses to the~     low vitamin K status. The hypotheses are:~        1. The daily intake of vitamin K is insufficient.~        2. Vitamin K is removed from the blood during dialysis.~        3. Absorption in the intestines is impaired.~        4. The analysis method (dephosphorylated-uncarboxylated MGP) is influenced by the patients'~          protein intake.~      The purpose of the fifth trial is to investigate solutions to improve the vitamin K status of~     hemodialysis. One is to improve vitamin K status through diet with an increased focus on~     foods with high concentrations of vitamin K while considering phosphate, potassium and fluid~     restrictions. The second is to increase vitamin K status through a daily supplement of 360µg~     Menakinon-7.~   "
5638|NCT03493074|"~     This study evaluates a novel noninvasive method to dynamically monitor the effect of~     abdominal aortic aneurysm (AAA) and endovascular treatment of AAA (EVAR) on arterial pulse~     wave~   "
5639|NCT03493061|"~     The aim of the trial is to optimize response rates and rates of secondary resections of~     metastases in patients with initially non-resectable metastatic colorectal cancer Liver~     Metastasis. The patients will be treated with systemic chemotherapy With irinotecan plus~     hepatic arterial infusion With floxuridine and oxaliplatin~   "
5640|NCT03493048|"~     The aim of the trial is to optimize response rates and rates of secondary resections of~     metastases in patients with initially non-resectable metastatic colorectal cancer Liver~     Metastasis of RAS wildtype. The patients will be treated in two therapy groups:~      Experimental arm A: Chemotherapy with FOLFOXIRI + Cetuximab Standard arm B: Chemotherapy with~     FOLFOX + Cetuximab~   "
5641|NCT03493035|"~     The aim of the research was to evaluate independent risk factors for the presence of middle~     cerebral artery aneurysm. Hemodynamic factors play the most important role in rupture~     aneurysm according hemodynamic theory. Geometry of division can influence flow blood.~     Division of the middle cerebral artery with or without aneurysm were analized using Mimisc~     software.~   "
5642|NCT03493022|"~     The objectives of this study are to examine the blood glucose and serum insulin response~     elicited by servings of Test Granola and Control Granola containing equal amounts of~     available carbohydrate over a 3 h time period. In addition, the subjective hunger response to~     these foods will be measured over 3 h.~   "
5643|NCT03493009|"~     The primary objective of this multicenter, prospective, randomized study is to evaluate the~     performance of Pure-Vu System in cleansing patients' colon who are indicated for a~     colonoscopy procedure using one of two different reduce bowel preparation regimes.in~     addition, the cecum intubation rate, time to cecum, total procedure time, and adverse event~     will be evaluated.~   "
5644|NCT03492996|"~     The primary objectives of the study are:~      • To assess the absorption, metabolism, excretion of LCB01-0371 after a single oral~     LCB01-0371 dose with a [14C]-LCB01-0371-tracer dose to healthy subjects~   "
5645|NCT03492983|"~     This is a randomized clinical trial aimed at postmenopausal women aged 50 to 64 years old~     selected in urban primary care centers of two centers (Spain). Its objective is to evaluate~     the effects of the additional intake of high cocoa content chocolate on blood pressure,~     vascular function, body composition, quality of life and cognitive performance.~   "
5646|NCT03492970|"~     Sleep-Wake and behavioral disorders in Smith Magenis Syndrome (SMS) are strongly linked to an~     inversion of the nychtemeral secretion of melatonin. This inversion have been described in~     children with SMS. However its evolution during adulthood remains unknown. The aim of this~     study is to assess 24hours melatonin levels in 10 adults with SMS in order to optimize~     medication in adults with SMS~   "
5647|NCT03492957|"~     The aim of this study is to design a physical activity programme for non-ambulatory stroke~     survivors (delivered via either community-based groups or a home-based individual programme)~     and evaluate its feasibility, acceptability, preliminary and adverse effects. The study will~     also explore the views of non-ambulatory stroke survivors and their carers on: needs,~     personal goals, barriers, and motivators, experiences of programme participated in and~     preferred format (i.e. home-based individual/ community-based groups).~   "
5648|NCT03492944|"~     The investigators plan to compare contrast-enhanced ultrasound to CT and MRI for the~     detection and quantification of intestinal inflammation in the the setting of pediatric small~     bowel Crohns disease~   "
5649|NCT03492931|"~     The purpose of this Phase I study is to investigate the pharmacokinetic properties of~     ticagrelor in pediatric patients from 0 to less than 24 months with sickle cell disease.~      Ticagrelor dose level adjustment will require a Protocol amendment and regulatory approval~   "
5650|NCT03492918|"~     Abbreviated Title : Pembrolizumab in hypermutated breast cancer Trial Phase : II Clinical~     Indication : Hormone receptor-positive metastatic breast cancer Trial Type : Interventional~     Type of control : None Route of administration : Intravenous Trial Blinding : None Treatment~     Groups : Pembrolizumab Number of trial subjects : Approximately 150 patients will be~     prescreened with whole exome sequencing. Then 30 patients will be enrolled in the treatment~     phase.~      Estimated enrollment period : 12 months Estimated duration of trial : The sponsor estimates~     that the trial will require approximately 24 months from the time the first subject signs the~     informed consent until the last subject's last visit.~      Duration of Participation : 12 months Estimated average length of treatment per patient : 8~     months~   "
5651|NCT03492905|"~     Insomnia is a commonly reported comorbidity for adolescents with psychiatric conditions. It~     is well-known that insomnia can exacerbate the concurrent psychiatric symptom load. Results~     from a pilot study shows that outpatients of Children and Youth Psychiatry can improve their~     sleep and depressive symptoms by receiving internet-based cognitive behavioral therapy for~     insomnia (iCBT). This study is designed to evaluate implementation of the treatment in~     routine care.The study will evaluate aspects of the implementation process such as~     organizational attitudes towards iCBT before implementation, level of knowledge about the~     condition and intervention among health-care providers before and after the implementation,~     and clinical outcomes in routine care.~   "
5653|NCT03492879|"~     The aims of this study are to assess the performance of the non-invasive Electrical Impedance~     Technology (EIT) in evaluating the liver fibrosis stage in patients with chronic liver~     diseases, in comparisons with a liver biopsy and/or Shear wave elastography and Liver~     Ultrasonography.~      The second aim is comparing between Liver Ultrasonography and Electrical Impedance Technology~     (EIT) to quantify the hepatic steatosis grade in patients with Non Alcoholic Fatty Liver~     Disease (NAFLD) .~   "
5654|NCT03492866|"~     The scalp-limited for of hereditary hypotrichosis simplex (HHS; MIM146520) is an autosomal~     dominant form of non-syndromic alopecia which is caused by heterozygous nonsense mutations in~     the CDSN gene, encoding corneodesmosin (1). The disease features diffuse gradual scalp hair~     loss that starts in the middle of the first decade of life and progresses to total alopecia~     till the third decade of life. Recent studies have shown that aminoglycosides have the~     potential to induce readthrough of nonsense mutations in human cells.~      The aim of this study is to investigate whether topical aminoglycosides (Gentamycin) may be~     beneficial for the treatment of HHS patients carrying nonsense mutations by inducing~     readthrough.~      The Study goals:~      To assess the short and long term efficacy of topical gentamycin for the treatment of~     hereditary hypotrichosis simplex caused by nonsense heterozygous mutations in CDSN.~      The primary end point:~      To assess scalp hair growth during study period as compared to baseline. Hair growth will be~     evaluated during enrollment and every 4 weeks. The secondary end points will be time to~     regrowth for determining efficacy.~   "
5655|NCT03492853|"~     Purpose: To examine the genotypes associated with the peripheral retinal phenotypic features~     in patients with age-related macular degeneration documented with wide-field imaging.~      Design: Clinic-based case series study in Croatia. Participants: 160 patients >50 years of~     age known to have early or advanced AMD and 150 subjects >50 years of age without known AMD~     (controls) Methods: Both groups of patients were examined with ophthalmoscopy and OCT to~     confirm their classification. Posterior and peripheral fundus features were documented with~     Optos wide-field imaging (Optos P200MA, Optos Plc, Dunfermline, Scotland) and graded. DNA was~     extracted from blood samples and gene polymorphisms were evaluated for complement factor H~     (CFH) rs1061170 and rs1410996, age-related maculopathy susceptibility (ARMS2) rs10490924,~     high temperature requirement factor A1 (HtrA1) rs11200638, complement factor B (CFB)~     rs4151667 and rs641153, complement factor 2 (C2) rs9332739 and rs547154 and complement factor~     3 (C3) rs2230199.~   "
5656|NCT03492840|"~     Lipedema and Dercum's disease are known as Rare Adipose Disorders; they are painful,~     progressive disorders that result in abnormal accumulations of fat in the form of lipomas,~     excess lymphatic fluid, and many other symptoms. This trial aims to study RZL-012, a novel~     compound, in treating lipedema and Dercum's disease by triggering lipolysis at selected sites~     and reducing fat bringing pain relief and improvement in quality of life.~   "
5657|NCT03492827|"~     Backgrounds： With the continuous improvement of sterilization and endoscopic structure, the~     infection caused by endoscopy has gradually declined.With the rapid development of digestive~     endoscopic therapy in the past decade, therapeutic endoscopy has been widely carried out~     worldwide. These techniques have caused the mucous membrane or deeper damage to achieve the~     goal of curing the disease. During therapeutic endoscopic procedures, endogenous bacteria may~     be ectopic to the blood circulation due to mucosal or deeper damage. The endoscope is used to~     in and out lumens multiple times, and the injections are injected into the tissues through~     the accessories. These processes may bring the pathogenic bacteria from the patient's mouth~     into the digestive tract through the endoscope and enter the blood through the damaged~     mucosa. In addition, bacteremia associated with endoscopic procedures may cause bacterial~     infections in distant organs (eg infective endocarditis).~      Postoperative infection rates can reach 12-22% . The results of the etiological culture show~     that it is consistent with the bacteria of oral bacteria. It is possibly related to multiple~     passage into the digestive tract of endoscopic and accessory . However, the endoscopic~     operation process will inevitably lead to subsequent infections.~      ESD treatment involves endoscopic multiple access to the upper digestive tract through the~     mouth, attachments and injection needles and other multiple exposure to the wound, so the~     probability of postoperative infection is significantly higher than the average endoscope.~      Investigators proposed to gargle patients with chlorhexidine acetate before ESD to improve~     the oral microenvironment and reduce the pathogenic bacteria in the oral cavity, so as to~     observe whether it can achieve the effect of preventing postoperative infection.~      Methods and patients~        1. Objectives: This study is a prospective randomized controlled study in single center of~          Peking University Third Hospital. The purpose of the study is to evaluate the preventive~          effect of chlorhexidine acetate gargle on the infection of early upper gastrointestinal~          cancer after endoscopic ESD therapy.~        2. Calculation of sample size: According to the postoperative infection rate of 10%, 25%~          improvement is given after the gargle is administered, and the error range is calculated~          at 2%. The sample size needs 306 cases.~   "
5658|NCT03492814|"~     This study compares the effect of two types of suturing techniques in the postoperative~     swelling and mouth opening after surgical removal of impacted mandibular third molar. total~     wound closure will be performed in one group of participants while partial closure will be~     performed in the other group.~   "
5659|NCT03492801|"~     This pilot research trial studies the collection of blood samples in monitoring tumor~     specific mutations in patients with non-small cell lung cancer that has spread to other~     places in the body or cannot be removed by surgery. Collecting blood samples may help measure~     the changes in lung cancer, better learn methods to track cancer in the bloodstream, and~     improve cancer treatments.~   "
5660|NCT03492788|"~     CRT is delivered from two electrodes on opposite sides of the heart [right (RV) and left~     ventricle (LV)] delivering stimulation for more efficient heart beats. There is flexibility~     in the sequence and temporal staggering of the stimulation from these two electrodes with a~     different optimum for different patients. However, standard techniques to figure out the~     optimal stimulation strategy like standard 12-lead surface electrical recording (ECG) or~     routine ultrasound have failed. The investigators have developed ECG imaging (ECGI) with 250~     electrode surface recording combined with CT scan to reconstruct high resolution~     4-dimensional panoramic electrical maps of the heart. The study seeks to enroll 56 patients~     undergoing CRT in a clinical trail to evaluate short and long term impact of using ECGI for~     optimal programming of CRT.~   "
5661|NCT03492775|"~     The objective of this study is to test whether a combined OBINUTUZUMAB/bendamustine therapy~     is superior to single agent OBINUTUZUMAB in medically non-fit, 'compromised' patients in~     terms of anti-lymphoma activity (primary objective), side effects, and quality of life. For~     the assessment of the anti-lymphoma activity the event free survival (EFS) will be applied~     as primary endpoint. EFS is defined as the time from the day of randomization to the date of~     first documented disease progression, death by any cause, or institution of a new~     anti-lymphoma treatment.~   "
5662|NCT03492762|"~     The primary objective of this study is to determine the safety of the novel probe~     64Cu-DOTA-ECL1i for PET imaging of CCR2 expression.~   "
21891|NCT03280498|"~     In this study the effectiveness of the use of Cole formula and USG were compared in~     determining the number of the appropriate uncuffed ETT to be used for clinically adequate~     ventilation.~   "
5663|NCT03492749|"~     Busulfan (Bu) has been widely used for the treatment of neoplastic and non-neoplastic~     hematological disturbances, with satisfactory results in terms of successful hematopoietic~     stem cell transplantation (HSCT). Individual monitoring of the Bu dosage, which is done by~     means of various blood sample collections, is necessary for the purpose of attaining ideal~     therapeutic levels and minimizing systemic toxicity. This procedure sometimes becomes costly~     to and uncomfortable for the patient. Saliva has been analyzed as a possible alternative~     fluid for this monitoring.~   "
5664|NCT03492736|"~     The investigators have previously shown that 1 week of 10mg Melatonin improves sleep~     consolidation in untreated obstructive sleep apnea (OSA) patients. This study aims to extend~     on those findings to determine if longer treatment of Melatonin improves other outcomes in~     untreated OSA patients.~   "
5665|NCT03492723|"~     This is a randomized, controlled, examiner-blind, 2-treatment parallel group study. The study~     will be conducted at the Hebrew University, Hadassah, Israel. A sufficient number of subjects~     will be screened to obtain approximately 200 generally healthy adult volunteers with mild to~     moderate periodontitis.~      Subjects will be stratified and randomly assigned equally to either the regimen group (AGE)~     or a control group (Placebo).~      Subjects will be requested to use the products at home for the duration of the study~     according to the written and verbal usage instructions given to them during product~     distribution. At Baseline, Month 6, 12, and 18 subjects will receive oral soft tissue exams,~     and will have gingival inflammation, bleeding, and periodontal measurements made as described~     in below.~      Both groups will receive supragingival dental prophylaxes every 6 month consistent with local~     norms and standards. Products will be re-supplied approximately every six months following~     Baseline. During study conduct, subjects with evidence of progressive periodontal disease (≥3~     mm increases in pocket depth, attachment loss or recession) will be exited from the study and~     treated following local norms.~   "
5666|NCT03492710|"~     To assess the safety, efficacy, and pharmacokinetics of IGIV-SN in pediatric subjects with~     primary immunodeficiency humoral diseases (PHID)~   "
5667|NCT03492697|"~     This open label study will evaluate the pharmacokinetics (PK) following single oral doses of~     different formulations of PF-06882961, including controlled release (CR) tablets at 2 release~     rates (long and short duration), an immediate release (IR) oral solution, and IR tablets, in~     healthy adult subjects.~   "
5668|NCT03492684|"~     A prospective study of 50 consecutive patients undergoing total hip arthroplasty, to~     establish whether there greater incidence of injury to the superior gluteal nerve associated~     with a particular approach (modified direct lateral approach). The patients will be assessed~     clinically and electrophysiologically before and after the operation through one year.~   "
5669|NCT03492671|"~     The purpose of this phase 2 research study is to determine whether a combination of~     chemotherapy drugs plus radiation therapy, given before surgery in resectable pancreactic~     cancer, can help to increase the chances of surgeons achieving and R0 resection. The~     chemotherapy drugs used are gemcitabine and nab-paclitaxel. These drugs are both approved by~     the FDA for use in treating adults with pancreatic adenocarcinoma. The investigational~     portion of this study is providing the chemotherapy drugs and radiation therapy before~     surgery. Primary Endpoint, R) resection rate ≥70%. Secondary Endpoints, Disease free~     survival, Overall survival , Perioperative mortality and morbidity.~   "
5670|NCT03492658|"~     To investigate the effect of CTLA4-Ig (abatacept) on phenotype, transcriptional profile, B~     cell receptor usage and functional parameters of circulating B cells expressing~     anticitrullinated protein antibodies (ACPA) in patients with early, methotrexate-naïve, ACPA~     positive rheumatoid arthritis.~   "
5671|NCT03492645|"~     The goal of the proposed project is to design and assess the acceptability and usability of a~     mobile technology and telephone-facilitated treatment to improve treatment engagement in~     adult smokers with posttraumatic stress disorder (PTSD). Smokers with PTSD face high rates of~     treatment failure and require tailored strategies that address both PTSD symptoms and smoking~     urges. McFall and Saxon designed a protocol combining office-based therapy plus~     evidence-based pharmacotherapies for smoking cessation that doubled quit rates in veteran~     smokers with PTSD. However, high rates of attrition limited efficacy. We aim to enhance~     scalability and engagement in the McFall/ Saxon protocol by (1) adapting the treatment to be~     delivered over the telephone and (2) leveraging innovations in technology by incorporating a~     mobile application targeting PTSD and smoking and a mobile carbon monoxide (CO) monitor into~     the protocol. We propose a mixed methods study in which we will adapt the office-based~     treatment into a technology and telephone-facilitated intervention and conduct a pilot RCT of~     the modified intervention with 20 veterans with PTSD. At the outset of the study, the study~     team will modify the original treatment manual in order for it to be delivered via telephone.~     We will then conduct a pilot RCT in which 20 veterans with PTSD will be randomized to receive~     the modified protocol (intervention condition; n=10) or the original office-based protocol~     (control condition, n=10). Main outcomes are quantitative and qualitative data about the~     acceptability of the intervention and its individual components, and treatment retention at~     Week 8. Secondary outcomes are 7-day bioverified point-prevalence cigarette abstinence, PTSD~     symptoms, and levels of nicotine dependence at follow-up. Results will inform a larger RCT to~     examine efficacy of the intervention in promoting quit attempts in smokers with PTSD.~   "
5672|NCT03492632|"~     Psoriasis is a common autoimmune disease. It affects women of all ages including reproductive~     years. Autoimmune diseases including psoriasis are linked to premature ovarian reserve. This~     study aims to measure serum hormones including FSH,LH,E2,PRL and AMH (indicators of ovarian~     reserve) in women with and without psoriasis.~   "
5673|NCT03492619|"~     The study develops, implements, and evaluates an intervention focused on alleviating~     discouragement, food insecurity, and excess weight in women,targeted at the individual,~     family, and community levels in the Canton Central of the province of Alajuela, Costa Rica.~   "
5674|NCT03492606|"~     Multiple sclerosis (MS) is a chronic inflammatory neurodegenerative disease associated with~     uncontrolled inflammation and autoimmunity and for which there is still an unmet need for new~     diagnostic and therapeutic options, especially for the progressive forms. Recent studies~     suggest that chronic inflammation can be a consequence of failure to resolve inflammation,~     the resolution of which is mediated by a newly discovered genus of highly potent~     anti-inflammatory lipids derived metabolically from omega-3 essential fatty acids and termed~     specialized pro-resolving lipid mediators (SPMs).~      Herein, we propose to identify SPMs as leads for the control of MS pathology and progression~     and to propose them as novel disease-modifying treatments by assessing their ex vivo/in vitro~     and in vivo role in modulating the balance of effector and regulatory cells and/or the~     mechanisms leading to chronicity as wells as in promoting activation of anti-inflammatory and~     neuroprotective pathways.~   "
6169|NCT03486106|"~     This study evaluates the effect of music and its influence on anesthetic requirements during~     total knee replacement surgery. Half of the participants will receive noise-cancelling~     headphones in the operating room, and the other half of participants will receive~     noise-cancelling headphones with music playing.~   "
5675|NCT03492593|"~     Consumption of foods containing carotenoids, as well as vitamin E, have been associated with~     lower risk of developing a number of chronic diseases. While the parent compounds have~     largely been assumed to exert protective antioxidant effects, more recent work has suggested~     that metabolites may be bioactive. Very little attention has been given to the metabolism of~     these compounds during the digestive process. Our primary aim is to conduct a postprandial~     feeding study in healthy men to determine the stability of carotenoids and vitamin E during~     digestion, and to identify the primary metabolites produced in various compartments of the~     upper gastrointestinal tract and blood during digestion. Targeted metabolites will be~     identified and quantitated using high-performance liquid chromatography-tandem mass~     spectrometry methods previously developed. In addition, a non-targeted metabolomics approach~     will be used to identify non-predicted metabolites in the samples. A better understanding of~     carotenoid and vitamin E stability and metabolism during digestion will provide greater~     insight into how these compounds may confer protection against chronic disease.~   "
5676|NCT03492580|"~     The primary purpose of study is to estimate the incidence and comparative effect on health~     outcomes: 1) hospitalization for heart failure, 2) below knee lower extremity amputation. The~     date of first exposure to the particular drug(s) in the database, where the exposure start is~     between 1-April-2013 to 15-May-2017 and outcome data for these participants will be analyzed~     and reported in this study.~   "
5677|NCT03492567|"~     The aim of the study is to look for risk factors of developing osteoporosis in patients with~     cystic fibrosis.~      Blood cells called monocytes will be obtained from a blood sample. These monocytes will make~     possible to form another class of cells called osteoclasts in the laboratory. These latter~     cells are responsible for bone degradation and therefore promote the increase of bone~     fragility. The research will focus on the characterization of these cells to better~     understand their potential (low, medium or high) to increase bone fragility in patients with~     cystic fibrosis.~      Finally the action of CFTR modulators on these bone cells will be tested.~   "
5678|NCT03492541|"~     The purpose of this study is to evaluate the clinical effectiveness and tolerability of~     SYSTANE® Complete in adult patients with dry eye disease. Fluorescein-stained tear film~     break-up time (TFBUT) will be evaluated as the primary objective.~   "
5679|NCT03492528|"~     The Mediterranean Group of Cardio-Oncology (GMEDICO) brings together French cardiologists and~     oncologists who have developed a protocol for the monitoring and cardio-oncological~     management of patients treated for cancer.~      This unique organization makes it possible to envisage the creation of a large cohort from~     which the incidence and predictive factors of cardiovascular toxicity can be determined.~      Primary objective: to determine the cardiovascular prognosis of patients treated for cancer~     and followed up in cardio-oncology.~      Secondary objectives~        -  To determine the clinical, biological and imaging factors associated with cardiovascular~          events under cancer treatment, in order to define a risk score including clinical,~          biological (biomarker) and imaging data.~        -  To create a biological source for testing other biomarkers and conducting genome-wide~          association studies and genetic factors associated with cardiovascular events under~          cancer treatment.~   "
5680|NCT03492515|"~     The purpose of this study was to observe the clinical efficacy and adverse reactions of rhTPO~     in the treatment of pregnancy-induced thrombocytopenia.~   "
5681|NCT03492502|"~     This study aims to assess the safety and efficacy of autologous fecal microbiota~     transplantation (FMT) in gastrointestinal (GI) related graft-versus-host disease (GVHD).~     Stool for FMT will be prepared from pre-allogeneic stem cell transplantation (Allo-SCT)~     period. This strategy might offer a novel and safe therapeutic approach for these patients,~     who suffer from high disease related morbidity and mortality and are refractory to multiple~     treatments.~   "
5682|NCT03492489|"~     The objective of this program is to provide access to cemiplimab (REGN2810) to patients with~     metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced cutaneous squamous~     cell carcinoma (laCSCC) who are not candidates for surgery prior to cemiplimab (REGN2810)~     being commercially available.~   "
5683|NCT03492476|"~     One of the difficulties encountered in the treatment of lymphedema, both in the active~     reduction phase and in the maintenance phase, is the appliance of the short-length~     compression bandages which requires good technicality and experience to exert the pressure~     required to remove liquids from tissue spaces and reduce the volume of the arm or prevent it~     from increasing again.~      The study aims to compare the current protocol of care considered optimal for the reduction~     of lymphedema and the maintenance of this reduction with the protocol of care which would~     integrate the device circaid® in substitution to the laying of bands with short extension as~     it is now in other countries.~   "
5684|NCT03492463|"~     This study plans to investigate whether using electronic cigarettes (e-cigarettes) or skin~     patches containing nicotine affects switching from smoking conventional combustible (burning)~     cigarettes.~   "
5685|NCT03492450|"~     The aim of the study is to set up a pilot study to investigate the effects of treadmill~     training in preventing the onset and worsening of walking impairments, balance deficits and~     fatigue.~   "
5686|NCT03492437|"~     This study will investigate the effect of Tepotinib on the pharmacokinetics (PK) of the~     p-glycoprotein (P-gp) probe substrate Dabigatran etexilate.~   "
5687|NCT03492424|"~     The purpose of this study is collect observational data regarding patterns of care and~     outcomes of focal therapies for prostate cancer, including but not limited to: high-intensity~     focused ultrasound (HIFU), cryotherapy, focal laser ablation, irreversible electroporation,~     photodynamic therapy, and brachytherapy.~   "
5688|NCT03492411|"~     This trial will evaluate an eHealth breastfeeding co-parenting resource designed for mothers~     and their co-parents. Couples will be randomized to study groups and the intervention group~     will receive information about this resource or the control group will receive usual care.~     The primary outcomes will be exclusive breastfeeding at 4 and 24 weeks postpartum.~   "
5689|NCT03492398|"~     A randomized, double-blind, placebo-controlled single and multiple dosing, dose escalation~     phase I clinical trial to investigate the safety/tolerability and pharmacokinetics of HY209~     gel after transdermal administration in healthy male volunteers as a possible treatment~     option for atopic dermatitis~   "
21953|NCT03279666|"~     The investigators will investigate patients pain and biopsy size during colposcopic biopsy.~     The investigators will use tenaculum randomized patient with or without intracervical~     blockage.~   "
5690|NCT03492385|"~     This is a Phase 1, first-in-human, randomized, double-blind, placebo-controlled, single~     ascending dose, sequential group study to evaluate the safety, tolerability,~     pharmacokinetics, and pharmacodynamics of PB2452 with and without ticagrelor pretreatment~     when administered to healthy male and female subjects.~      Up to 6 dose levels will be evaluated. This study will have up to 9 cohorts and up to a total~     of approximately 60 subjects with either 4 or 8 subjects in each cohort depending on the~     dose. The starting dose of PB2452 will be 100 mg and the planned doses for subsequent cohorts~     are 300, 1000, 3000, 9000, and 18000 mg.~   "
5691|NCT03492372|"~     The researchers are trying to identify molecular mechanisms that control spine deformity and~     degenerative changes that can be used for therapeutic strategies.~   "
5692|NCT03492359|"~     To demonstrate differences in tidal breathing patterns measured by SLP(Structured Light~     Plethysmography) between healthy subjects and COPD (chronic obstructive pulmonary disease).~     The correlation between SLP parameters and standard lung function parameters measured by body~     box and spirometry will also be assessed. Trends in SLP breathing patterns between the~     different GOLD (Global Initiative for Chronic Obstructive Lung Disease) stages of COPD, and~     between those and healthy subjects, will be investigated to assess whether SLP can detect~     differences between groups.~   "
5693|NCT03492346|"~     This study is to recruit and establish baseline measurements for potential subjects that may~     be eligible for a gene therapy trial. Specifically, this trial is recruiting individuals who~     are suspected or have been confirmed to have Limb Girdle Muscular Dystrophy type 2E (LGMD2E).~   "
5694|NCT03492333|"~     Gluten-free diet has been shown to improve gut symptoms in patients with celiac disease and~     also in adult patients with diagnosis of Irritable Bowel Syndrome (Rome III criteria).~      Antibodies to native gliadin (AGA) have been suggested as a potential diagnostic marker of~     response to GFD. However, this has not been tested in a prospective study in IBS patients.~     Identification of predictors of a symptomatic response to GFD within the IBS population would~     improve the clinical management of these patients.~      The purpose of this study is to evaluate the effect of gluten-free diet on gastrointestinal~     symptoms and gut motility in patients with Irritable Bowel Syndrome stratified according to~     their antigliadin antibodies status.~      Additional purposes include investigating effects gluten free diet may have on other~     parameters:~        -  Improvement of mood~        -  Quality of life and general well-being~        -  Changes in gut microbiota~   "
5695|NCT03492320|"~     To evaluate the progression on patients suffering from end stage OA whilst being on the~     waiting list for TKR~   "
5696|NCT03492307|"~     This is a pilot study comparing a weight-based high-flow nasal cannula (HFNC) protocol with~     the current standard HFNC protocol for children <2yo admitted to South Shore Hospital with~     bronchiolitis. We currently use a flat limit of 8 liters of HFNC to support work of breathing~     and hypoxia in these patients. We will compare that to a weight-based protocol, which will~     provide 2L/kg/min of flow (flows generally between 6 and 20L/minute) to this patient~     population. The goal of this pilot study is to assess the feasibility of our study design. We~     will evaluate the functionality of a new weight-based flow protocol. We will also evaluate~     the functionality of a new bronchiolitis scoring tool, the Bronchiolitis Assessment Severity~     Score (BASS), and it's ability to guide care through the new protocol. We are also testing~     the feasibility of recruitment, randomization and retention. We are ultimately interested in~     whether a weight-based flow protocol reduces need for escalation to ICU-level care for~     children with moderate-severe bronchiolitis on HFNC.~   "
5697|NCT03492294|"~     The aim of the present study was to evaluated the neural effect of music on the cerebral~     activation in unresponsive wakefulness syndrome (UWS) and minimally conscious state (MCS) by~     using functional magnetic resonance imaging (fMRI).~   "
5698|NCT03492281|"~     This study is designed to evaluate the safety, tolerability, and efficacy of vibegron~     administered once daily in patients with OAB.~   "
5699|NCT03492268|"~     This trial aims to evaluate the safety and efficacy of BCMA-CART in treating patients with~     relapsed or treatment refractory multiple myeloma.~   "
5700|NCT03492255|"~     Glucocorticoids (GC) use has increased survival of patients with systemic lupus erythematosus~     (SLE), particularly in cases of nephritis and a more significant improvement to 80% with the~     introduction of therapy combined with immunosuppressants. This therapeutic scheme, however,~     results in a very high incidence of irreversible damage that is associated in more than 70%~     of the cases to GC use and in a smaller proportion to the use of high dose cyclophosphamide.~      CYCLONES is a Controlled Randomized Clinical Trial with the aim of evaluating the efficacy of~     a regimen for lupus nephritis treatment using only intravenous corticosteroid administration.~     This intravenous corticosteroid regimen has already been tested (with Rituximab instead of~     Cyclophosphamide) with high response rates for lupus nephritis and significant reduction of~     side effects.~      After selection, patients will be randomized in two arms: 116 patients will receive~     Euro-Lupus nephritis regimen and other 116 will undergo treatment with CYCLONES regimen.~      The primary endpoint is the partial response (protein/creatinine ratio < 3 with decrease at~     least of 50% of the initial value and increase of creatinine not higher than 15% of the~     initial value) or complete response (protein/creatinine ratio < 500 with decrease at least of~     50% of the initial value and increase of creatinine not higher than 15% of the initial value~     in 6 months. Secondary outcome measures will be evaluated such as osteoporosis and bone~     metabolism parameters, ophthalmologic evaluation of the collateral effects related to~     glucocorticoids, lipid profile and therapy adherence.~   "
5701|NCT03492242|"~     Immune checkpoint inhibitors (ICIs) might have high grade immune-related adverse events~     (irAEs) from rhumatologic, endocrinologic, cardiac or other system origin. This study~     investigates reports of drug induced irAEs with treatment including anti-PD1, Anti-PDL-1, and~     Anti-CTLA4 classes using the World Health Organization (WHO) database VigiBase and the french~     database Base Nationale de PharmacoVigilance (BNPV).~   "
5702|NCT03492229|"~     Over four million stroke survivors currently living in the United States are unable to walk~     independently in the community. To increase the effectiveness of gait rehabilitation, it is~     critical to develop therapies that are based on an understanding of brain adaptations that~     occur after stroke. This project will be the first step towards the development of a novel~     therapeutic approach using brain stimulation to increase walking capacity in stroke survivors~     and understand the neural mechanisms that are associated with impairment and functional~     recovery.~   "
5703|NCT03492216|"~     There is an urgent global need to decrease the high mortality of tuberculosis (TB) in persons~     with HIV as TB is the leading cause of death among persons with HIV worldwide. The DIPT~     (Drinkers' Intervention to Prevent TB) study is a randomized, 2x2 factorial trial among~     HIV/TB co-infected adults in Uganda with heavy alcohol use (n=680 persons, 340 each U01). The~     goal of the study is to determine whether economic incentive interventions can promote both~     reduced alcohol use and isoniazid (INH) pill taking among HIV/TB co-infected adult heavy~     drinkers, during isoniazid preventive therapy (IPT: a six-month course of INH) at HIV clinics~     in southwestern Uganda. Participants will be randomized to one of four arms: Arm 1: no~     incentives (control); Arm 2: economic incentives for decreasing alcohol use only; Arm 3:~     economic incentives for IPT adherence only; Arm 4: economic incentives for decreasing alcohol~     use and for IPT adherence (rewarded independently).~   "
5704|NCT03492203|"~     Major depressive disorder is the number one cause of disability worldwide. Evidence regarding~     the effectiveness of various treatments for patients with severe depression is still lacking.~     Although many patients achieve treatment response, only a minority of patients achieve full~     remission and even fewer sustain it. In fact, within one month 10% will be re-hospitalized~     and the rate climbs to 30% within a year. Further, remission from depressive symptoms is a~     surprisingly poor predictor of recovery of community functioning following discharge. It is~     clear that the traditional focus on diagnostic symptoms is insufficient for promoting a full~     return to everyday functioning. The present aim is to examine the efficacy and effectiveness~     of treating neurocognition, a symptom that explains persistent deficits in community~     functioning for those with depression. The study design that maps on to the contemporary~     clinical setting, in order to reflect the changing landscape of inpatient and community~     treatment.~   "
5705|NCT03492190|"~     The quality of protein intake has an important role within the nutritional needs of people~     throughout their lives around the world, particularly in developing countries and in~     particular during pregnancy and early childhood. It is likely that adequate protein reduce by~     40% the prevalence of stunting (low height for age) in children under five years, according~     to World Health Organization data. Uncertainty about the quality of the diet, specifically~     with reference to quality proteins has potential impacts on health, economy, agriculture, and~     food security of a nation. The amino acid digestibility estimates based on stool analysis do~     not represent the amount of absorbed amino acid. Ideally, the bioavailable amino acid should~     be measured by methods that assess the difference between consumed and absorbed amino acids.~     However, the uptake of amino acids is not readily non-invasively measured in healthy humans.~     The use of vegetable protein intrinsically labeled by stable isotopes offers a solution to~     this problem. The deuterated water (2H2O), with relatively low cost, is suitable for labeling~     plant proteins such as those of beans. The labeled amino acids are present in the test meal~     ingested and incorporated into the blood, representing a single measure of bioavailability.~     This study aims to develop and apply a new methodology, using stable isotopes, to evaluate~     the bioavailability of bean protein, a very important food in the Brazilian diet, according~     to cooking procedures, through the use of deuterium. The project will be divided into two~     parts: a human nutrition and an agriculture part, the latter by planting/harvesting~     deuterium-labeled Phaseolus vulgaris L. After two weeks of blooming, deuterium water will be~     added to the bean crop, which will be subsequently dried. Chemical analysis and assessment of~     incorporation of deuterium in the beans will be done. Concurrent with the cultivation of~     beans, there will be a protein absorption test with 15 healthy volunteers for validation of~     the methods. For comparison purposes, milk protein labeled with deuterium and C13 will be~     used. The volunteers will consume the test meals. Blood, urine and saliva samples will be~     collected at baseline (before food ingestion), and in different times after the meal. In the~     next phase of this research, labeled beans produced by the agriculture experiment will be~     used to measure the protein absorption of volunteers of different groups (older persons, and~     stunting and non-stunting children). The samples will analyzed by isotope-ratio mass~     spectrometry. This methodology may promote a better understanding of the absorption of~     proteins and amino acids using less invasive methods in different age groups and clinical~     conditions. This work will have an important impact for the general population as well as for~     agriculture and health-related professionals.~   "
5706|NCT03492177|"~     Selexipag is available for the treatment of pulmonary arterial hypertension (PAH) in adults~     in various countries. The efficacy of selexipag to delay disease progression was shown in a~     previous pivotal study conducted in 1156 adult patients with PAH. Given the similarities in~     the functional changes of PAH in children and adults, it is expected that children suffering~     from PAH could benefit from treatment with selexipag. The aim of the present study is to~     confirm the doses of selexipag to be used in pediatric patients with PAH older than 2 years.~     To fulfill this aim, blood levels of selexipag (pharmacokinetic assessments) as well as the~     safety, and tolerability of selexipag in children with PAH will be assessed.~   "
5707|NCT03492164|"~     We plan to enroll 30 evaluable patients with (1) a histological diagnosis of advanced~     pancreatic ductal adenocarcinoma who have demonstrated at least stable disease following ≥16~     weeks of treatment with platinum-based chemotherapy and (2) who have signed consent to~     participate in a clinical trial that contains PARP inhibitor therapy and are anticipated to~     receive this treatment or (3) will receive PARP inhibitor therapy as part of their clinical~     care.~      A pre-treatment 18F-FluorThanatrace ([18F]FTT) positron emission tomography/computed~     tomography (PET/CT) scan will be done prior to the start of treatment with a PARP inhibitor.~      PET/CT imaging will be used to evaluate PARP-1 expression in sites of pancreatic cancer using~     the investigational radiotracer [18F]FTT. This is an observational study in that [18F]FTT~     PET/CT will not be used to direct treatment decisions. While patients and referring~     physicians will not be blinded to the [18F]FTT PET/CT results, treatment decisions will be~     made by the treating physicians based upon clinical criteria.~      Patients will undergo approximately 60 minutes of dynamic scanning starting at the time of~     injection of [18F]FTT. This procedure will be followed by a skull base to mid-thigh scan,~     starting at approximately 60 minutes post injection. PET/CT imaging sessions will include an~     injection of approximately 10 mCi (approximate range for most studies is anticipated to be~     8-12 mCi) of [18F]FTT. Data will be collected to evaluate uptake of [18F]FTT in sites of~     pancreatic cancer, which will be compared with PARP-1 expression in tissue, when available.~      All 30 evaluable patients are expected to start PARP inhibitor therapy following the [18F]FTT~     PET/CT scan. It is expected that due to patient preference and time considerations,~     approximately 24 patients (80%) will also undergo a second (optional) scan that will be~     performed approximately 3 weeks (± 1 week) after therapy has started. The second scan is~     obtained to evaluate whether the PARP inhibitor therapy decreases [18F]FTT uptake, which~     would suggest PARP blocking by the therapy.~   "
5708|NCT03492151|"~     The study schema is shown in Figure 4. (A) All patients referred to one of the participating~     academic centers for EUS evaluation of the PCL will be enrolled in the protocol if they~     satisfy inclusion criteria. Patient consent will be obtained during the clinic visit or prior~     to their EUS. EUS-guided nCLE imaging is first performed (B) followed by EUS-guided FNA and~     aspiration of cyst fluid. The cyst fluid is analyzed for CEA and cytology. As per~     institutional standard of care, the cyst fluid is also sent for molecular analysis. The~     results of the cyst fluid molecular analysis (B) will be utilized for the most likely~     diagnosis. Based on institutional multidisciplinary tumor board meetings, surgery is~     performed as indicated (C). Surgical histopathology serves as gold standard for diagnosis.~     It is anticipated that the majority of patients will undergo surgical resection after their~     EUS.~   "
5723|NCT03491956|"~     Little clinic trials showed that Double Filtration Plasmapheresis (DFPP) could improve lipid~     metabolism, however, whether DFPP can improve platelet function and recover Endothelial~     function is unknown. In this study, we try to confirm the hypothesis that DFPP can improve~     endothelial function in hyperlipidemia patients.~   "
5724|NCT03491943|"~     Ultrasound has emerged as an useful tool for neuraxial blockade. The aim of this study is to~     compare the efficacy and safety between the midline approach and paramedian approach for~     ultrasound-assisted spinal anesthesia in adult patients.~   "
5709|NCT03492138|"~     ONC201 is a novel dopamine receptor D2 antagonist that is able to activate the integrated~     stress response pathway. It is active against multiple myeloma cells in vitro, both as a~     single agent and in combination with corticosteroids and proteasome inhibitors. In order to~     document superiority over the combination compared to the individual agents of ixazomib and~     ONC201 in a single arm study, there will initially be a run-in period of weekly ONC201 625 mg~     with dexamethasone 40 mg such that if there is progression of disease (25% increase) after 4~     weeks or less than a minimal response (25% reduction) after 8 weeks then ixazomib will be~     added. Dexamethasone is dose-reduced to 20 mg at the same schedule for subjects ≥ 75 years~     old. If patients do achieve single-agent responses with ONC201 (minimal response or better),~     they will continue with weekly ONC201 and dexamethasone until progression, with response~     assessments after each 28-day cycle. Patients who have previously been treated on another~     clinical trial with weekly ONC201 625mg with dexamethasone with progression while receiving~     treatment do not need to complete the run-in phase of the study.~      At the time of progression, they will proceed to the 3 drug combination phase of the study.~     It is at the point of 3 drug initiation, that below phase I DLT principles or phase II~     disease control rate considerations apply.~   "
5710|NCT03492125|"~     A Phase I Dose-Escalation Study Of The Selective PKC-Β Inhibitor MS-553 In Patients With~     Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma~   "
5711|NCT03492112|"~     TEMPO is an interventional cohort study recruiting injecting drug users attending needle and~     syringe programs (NSP) in Australia. Three hundred participants will be invited to on-site~     HCV testing with NSP integrated care for HCV treatment.~      Participants will be screened for HCV using point-of-care testing and HCV positive~     participants will be offered treatment with Sofosbuvir/Velpatasvir. Of those who initiate~     treatment, participants will receive weekly peer-based support on-treatment and return at End~     of Treatment (ETR) and 12 weeks following end of treatment (SVR12) for clinical follow-up.~   "
5712|NCT03492099|"~     This study will assess the safety of changing pain medications (opioids) adult sickle cell~     patients take to another type of medication therapy (buprenorphine). Patients will be asked~     questions about their quality of life. Other tools for assessment will also be administered.~   "
5713|NCT03492086|"~     Bioactive supplements might display relevant therapeutic properties according to validated~     molecular effects. Herein, the effect of a supplement based on diterpenes from Rosmarinus~     Officinalis L. and alkylglycerols with proven properties against signaling pathways involved~     in tumorigenesis is evaluated. The biological and molecular effects of this supplement,~     mainly based on expected effects on immune and genetic modulatory properties is investigated.~     For this purpose, 60 healthy volunteers were enrolled in a six week, double-blind, randomized~     and parallel pilot study with two study arms -rosemary and alkylglycerol containing capsules~     and control capsules. The study includes the analysis of (1) immunological parameters (ex~     vivo cytokine profile of LPS stimulated PBMC and PBMC phenotyping by cluster differentiation~     (CD) markers), (2) regulation of the expression of genes linked to immuno-modulation,~     inflammation, oxidative stress response and cancer, and (3) the analysis of correlation of~     selected genetic variants (SNPs) with the differential responses among individuals.~   "
5714|NCT03492073|"~     The importance of emotional regulation interventions in cancer patients and primary~     caregivers is clearly established, since it helps them manage their emotions.~      The aim of the study was to analyze the differential effect between two Emotional Support~     programs, one of them based on Mindfulness, and the other one Emotional Support as usual, on~     advanced cancer patients (stage III & IV) admitted to a Madrid Community Hospital La Paz and~     their relatives.~   "
5715|NCT03492060|"~     The purpose of this study is to analyze patterns in individuals with HNRNPH2 genetic~     variants, including their neurological comorbidities, other medical problems and any~     treatment. We will maintain an ongoing database of medical data that is otherwise being~     collected for routine medical care. We will also collect data prospectively in the form of~     questionnaires, neuropsychological, and motor assessments to examine the landscape of~     deleterious variants in this gene.~   "
5716|NCT03492047|"~     The purpose of the study is to evaluate the effect of N-acetyl cysteine in combination with~     paclitaxel on the clinical outcomes of patients with peripheral neuropathy,~     paclitaxel-induced peripheral neuropathy affect quality of life in cancer patients.~      new therapeutic approches such as the antioxidant N-acetyl cysteine, showed to has~     neuroprotective effect, the aim of the study is to evaluate the effect of N-~     acetylcysteine(NAC) administration in the prevention of paclitaxel-Induced peripheral~     neuropathy.~   "
5717|NCT03492034|"~     Insertion of Intrauterine Contraceptive Device during Cesarean Section: Randomized Clinical~     Trial~   "
5718|NCT03492021|"~     Musculoskeletal injury, particularly injuries requiring surgical repair, induce significant~     muscle atrophy, resulting in diminished physical function. The protein turnover-associated~     (diminished protein synthesis, elevated protein breakdown, negative net muscle protein~     balance) etiology of injury and surgical-induced atrophy are, in part, similar to those~     observed with muscle wasting induced by hyper-catabolic and inflammatory conditions and~     prolonged periods of skeletal muscle disuse (e.g., cachexia and joint immobilization).~     Combining dietary strategies to optimize the anabolic properties of beef as a high quality~     protein source that provides essential amino acids prior to surgery and throughout~     post-surgery rehabilitation may attenuate muscle atrophy and accelerate the restoration of~     muscle function. This project will examine the efficacy of habitual consumption of a~     beef-based higher protein meal pattern and post-physical rehabilitation beef protein~     supplementation throughout post-surgical rehabilitation intervention on skeletal muscle~     function in response to anterior cruciate ligament (ACL) repair in healthy, physically active~     adults.~      Stable isotope methodologies, proteomic analysis of muscle protein synthesis, and molecular~     assessments of skeletal muscle atrophy and remodeling will be assessed to evaluate the~     effects of increased protein intake, including consumption of a high quality beef-based~     protein supplement following patient physical therapy sessions on:~        1. Skeletal muscle protein fractional synthetic rates during and in recovery from surgery;~        2. Inflammatory, proteolytic, and anabolic intramuscular signaling during surgery and their~          association with skeletal muscle protein synthesis and muscle function;~        3. Muscle size and functional recovery;~        4. Duration to return to routine exercise, sport, or physical activity.~   "
5719|NCT03492008|"~     This study compares two modified techniques(contralateral cricothyroid pressure and~     ipsilateral head turning technique) of nasogastric tube insertion in anesthetized and~     intubated patients with the conventional technique.~   "
5720|NCT03491995|"~     The triple treatment including Proton pump inhibitor (PPI) -clarithromycin and amoxicillin or~     metronidazole was proposed 30 years ago at the first Maastricht conference to treat~     helicobacter pylori (H. pylori) infection and since that time, it has become the universal~     and standard treatment for helicobacter pylori.~      However, the efficacy of this triple regimen has been seriously challenged, and they are~     gradually becoming ineffective~   "
5725|NCT03491930|"~     The purpose of this study is to determine if a weight loss app (VA MOVE!® Coach App) along~     with regularly scheduled telephone counseling, will motivate obese people with metabolic~     syndrome to lose weight and improve the symptoms of the metabolic syndrome, compared to usual~     weight loss approaches. This study will randomly assign participants to one of two groups,~     interventional or control. The interventional group will use the app with phone coaching and~     standard of care for weight loss. The control group will receive standard weight loss care~     without the app and phone coaching. Weight loss motivation to adopt life-style changes to~     maintain weight loss and quality of life between the two groups will be compared. The~     metabolic syndrome (MetS) is a cluster of disorders including high blood pressure,~     pre-diabetes, the tendency to carry body weight around the waist, and increased fat in the~     blood. When these problems happen together, there is an increased risk for heart attack,~     stroke, diabetes and certain cancers.~      Although the metabolic syndrome is a serious condition, it can be treated with diet, weight~     loss and increased activity. It can even be reversed using these lifestyle changes. Due to~     poor success with routine short-term weight loss treatment (group and one-on-one counseling),~     it is time to address the problem by a different method. Studies have shown feedback devices~     and weight loss apps have been successful in weight loss and weight maintenance. They are~     economical (many apps are free), and convenient to use, without attendance at group sessions.~     Since weight loss is the corner stone for improvement in the symptoms of the MetS, this study~     will offer a unique approach to support individuals who are committed to losing weight and~     adopting a healthier lifestyle.~      Numerous studies demonstrated that feedback via text messaging, and interaction through~     social networking support groups, in addition to iPhone apps, are all more effective in~     weight loss measures than group sessions at a hospital site. (Duncan et al., 2011; Greene,~     Sacks, Piniewski, Kil, & Hahn, 2012; Shaw et al., 2013; Spring et al., 2013). The benefit of~     these various methods is that they appear to accelerate weight loss and prevent weight~     re-gain if employed long-term. With technology changing daily, these approaches must be~     considered an essential adjunct to, or replacement for, traditional group counselling~     sessions.~   "
5726|NCT03491917|"~     The purpose of this pilot is to provide credible performance estimate information in order to~     conduct a subsequent pivotal reader study.~   "
5727|NCT03491904|"~     The primary objective is to demonstrate that the Prefilled Syringe (PFS) and the~     auto-injector(AI) are suitable to be used to administer fasinumab at home by patients or~     their caregivers, as measured by collecting 12 weeks of actual-use data on the technical~     performance of each device. The secondary objectives of the study are to evaluate the~     successful injection of fasinumab by patients or their caregivers using an AI or PFS in an~     unsupervised setting, evaluate patient/caregiver satisfaction with the AI and the PFS for~     fasinumab injection in an unsupervised setting, evaluate exposure in serum for fasinumab~     administered by patients or their caregivers using an AI, or a PFS that has been used in the~     phase 3 program, characterize the safety, tolerability, and immunogenicity of fasinumab~     administered by patients or their caregivers using an AI or PFS in an unsupervised setting.~   "
5728|NCT03491891|"~     We sought to identify and verify independent correlates of Very Late Stent Thrombosis after~     the implantation of new generation drug eluting steng in China from an analysis of~     multicenter registries.~   "
5729|NCT03491878|"~     Introduction: Surgery is the only potential curative approach for the highly lethal~     gallbladder carcinoma. The laparoscopic surgery has developed rapidly since invented. As a~     kind of minimally invasive surgery, laparoscopic cholecystectomy including segmentg IVB and V~     is preferred by most of surgeons. There have been studies comparing intraoperative blood~     loss, postoperative morbidity, length of hospital stay and costs of laparoscopic~     cholecystectomy over open surgery. However, randomized controlled trials are still lacking~     but clearly required to reveal whether the laparoscopic approach or the open surgery is the~     better option for treating gallbladder carcinoma. We hypothesize that incidence of~     postoperative complications is lower, and time to functional recovery is shorter after~     laparosopic compared with open approach, even in an enhanced recovery setting.~      Methods/design: We designed this prospective, randomized, controlled trial with two treatment~     approaches, laparoscopic versus open surgery for gallbladder carcinoma. The trial hypothesis~     is that laparoscopic approach has advantages in postoperative recoveries and be equivalent in~     operation time, oncological results and long-term follow-up compared with open counterpart.~     The duration of the entire trial is four years including prearrangement, follow-up and~     analyses.~      Discussion: Although several studies have discussed different surgical approaches for~     gallbladder carcinoma treatment, this trial will be a thorough RCT comparing laparoscopic and~     open surgery for gallbladder carcinoma.~   "
5730|NCT03491865|"~     In Phase I, the REAL media Plus prototype will be developed and a usability test conducted~     among students and teachers.~      In Phase II a group randomized trial will be conducted among 27 high schools to evaluate the~     effects of REAL media Plus on smoking and vaping.~   "
5731|NCT03491852|"~     Stigma towards mental illness is one of the greatest barriers to functional recovery that~     people with psychotic disorders face. Internalization of stigma (self-stigma) is associated~     with increased depressive symptoms, treatment non-adherence, and reduced quality of life.~     Self-stigma also has functional consequences, such as social avoidance and decreased~     help-seeking behaviour, which may worsen symptoms and impede recovery. Despite a growing~     awareness of the negative outcomes associated with self-stigma, few interventions have been~     designed to specifically address this experience in first episode psychosis. This project~     proposes to determine the effectiveness of an innovative, youth-oriented, group-based~     intervention known as Be Outspoken and Overcome Stigmatizing Thoughts (BOOST), which aims to~     reduce self-stigma and promote effective communication skills for adults (16-65 years old)~     experiencing a first episode of psychosis.~   "
5732|NCT03491839|"~     modelling of tidal volume with inhalational anesthetic concentration~   "
5733|NCT03491826|"~     The aim of this study is to compare fetal and maternal outcome in cases of PPROM before 34~     weeks versus after 34 weeks.~   "
5734|NCT03491813|"~     The present study aims to show the difference of blood pressure monitored centrally and~     automated BP monitoring among patients with primary hypertension for early detection of~     kidney dysfunction~   "
5735|NCT03491800|"~     The purpose of this study is to conduct a pilot study in 30 Heart Failure (HF) patients and~     visit companions (i.e., a family member who accompanies the patient to medical visits), to~     evaluate a pre- visit question/topic prompt list, designed to enhance patient and family~     member engagement during visits by providing a list of questions or topics that they may want~     to discuss with their health care provider.~   "
5736|NCT03491787|"~     The aim of this field report is to describe as the use ultrasound guidance can facilitate the~     insertion of intraosseous access, during the resuscitation, in the victims of out-of hospital~     traumatic cardiac arrest~   "
6354|NCT03483675|"~     This randomized trial studies how well discontinuation or continuation of immunosuppressive~     therapy works in treating participants with chronic graft versus host disease. Continuation~     of immunosuppressive treatment may prevent graft-versus-host disease worsening.~   "
5737|NCT03491774|"~     The study has both quantitative and qualitative components.~      The objective of the quantitative study is:~        1. To culturally adapt and refine Montessori activities for people living with dementia in~          Pakistan.~        2. To determine the feasibility and acceptability of culturally-adapted group based~          Montessori intervention for people with dementia in Pakistan.~        3. To build capacity and capability in dementia research (researcher training)~      The objective of the qualitative study is:~      To explore views on perceived effectiveness and sustainability of the study.~   "
5738|NCT03491761|"~     This is a single-center, prospective, randomized, single-blind, comparator therapy, parallel~     group study for symptomatic patients diagnosed with knee osteoarthritis. The aim is to~     demonstrate superior efficacy of platelet-rich plasma (PRP) as compared to hyaluronic acid~     (HA) in treating knee osteoarthritis. This aim will be objectively measured by endpoint~     consisting of changes in cartilage thickness from baseline in the MRI. The Western Ontario~     and McMaster Universities Osteoarthritis Index (WOMAC), total score at 12 months, will~     measure changes in pain and function from baseline. Approximately 100 subjects will be~     treated at NorthShore University HealthSystem as part of this study. This study has the~     potential to improve outcomes in a very common chronic degenerative disease, osteoarthritis,~     which can have a significant effect on individuals' quality of life.~   "
5739|NCT03491748|"~     This research project is being conducted to investigate the safety, tolerability, and~     pharmacokinetics (PK) of a single ascending dose (SAD) and multiple ascending doses (MAD) of~     oral ETX0282 when administered alone and in combination with cefpodoxime proxetil in healthy~     adult participants.~   "
5740|NCT03491735|"~     In this study, we are aiming to identify the patterns of glaucoma observed and treated at~     Glaucoma Subspecialty Clinics of Kasr Al-Aini Hospital, Cairo University in Cairo, Egypt and~     corresponding clinics in Sadguru Netra Chikitsalaya Post Graduate Institute of Ophthalmology~     in Mumbai, Maharashtra, India during the year 2018. We are hoping that this study would~     provide an update on current statistics available on Indian population as well as provide~     novel numbers on the prevalence of glaucoma and its patterns in one of the largest tertiary~     care hospitals in Egypt. These results will then be compared to patterns observed in other~     epidemiological studies done in other countries.~   "
5741|NCT03491722|"~     The study will look at the cardiovascular risk factors as they arise, as well at the need for~     further revascularization after at least 10 years of coronary revascularization in Middle~     Eastern patients~   "
5742|NCT03491709|"~     Colorectal cancer (CRC) is one of the most common human malignant tumors. The incidence and~     mortality of colorectal cancer in our country are on the rise. Surgery-based, combined with~     chemotherapy, radiotherapy comprehensive treatment, is the main treatment of colorectal~     cancer. Surgical resection has been recognized as the primary treatment of colorectal cancer.~     However, due to the majority of patients already advanced at the time of diagnosis, some~     difficulties are brought to radical surgery. Therefore, the importance of chemotherapy for~     colorectal cancer gradually been clinically recognized, But rarely survive more than 18~     months. In addition to chemotherapy, there is now a more ideal model of cancer treatment-~     molecular targeted therapies, including monoclonal antibody drugs such as cetuximab, as well~     as small molecule tyrosine kinases Inhibitors gefitinib and so on. Molecular targeted drugs~     make use of the difference in molecular biology between tumor cells and normal cells.~     Targeting drugs to tumor cells and inhibiting the growth and proliferation of the cells can~     achieve the therapeutic effect, which has the advantages of high specificity and low adverse~     reaction. The bio-targeted drug cetuximab is the first drug approved to marketed as an~     epidermal growth factor receptor (EGFR)-targeting immunoglobulin 1（IgG1）monoclonal antibody.~     Cetuximab, either monotherapy or combined radiotherapy and chemotherapy, can exert excellent~     anti-tumor activity in EGFR-positive malignant tumors and can significantly enhance the~     efficacy of radiotherapy and chemotherapy.~      Reference to cetuximab injection, guilin sanjin Co., Ltd. and dragonboat Co., Ltd. jointly~     developed a recombinant anti-EGFR human mouse chimeric monoclonal antibody (R & D code:~     CDP1).The primary structure of CDP1 is exactly the same with cetuximab, the higher structure~     and Physical and chemical properties and cetuximab are highly similar. Pharmacodynamic~     activity in vivo and in vitro, pharmacokinetic characteristics and toxicological reactions~     are also similar to cetuximab. CDP1 selected with cetuximab consistent formulations,~     prescriptions, specifications.~      CDP1 was approved by China Food and Drug Administration (No. 2016L06884) in August 2016 for~     clinical studies. According to the contents of the document and guidelines for biological~     analogs, the clinical pharmacokinetic and clinical effectiveness comparison tests of CDP1 and~     the safety and immunogenicity assessment are planned.~   "
5743|NCT03491696|"~     The hypothesis of a link between depression and Hypothalamic-Pituitary Axis (HPA) dysfunction~     is now experienced. Since a first description in 1949 this link has made the HPA one of the~     most investigated hormonal axis in depression.~      Many studies have demonstrated quantitative variations of circulating cortisol in situation~     of depression including increasing of basal concentration of blood cortisol or~     Adrenocorticotropic Hormone (ACTH). Furthermore there is an attenuated negative feedback~     performance of the blood cortisol on the release of ACTH and cortisol. This attenuation seems~     to be a consequence of a bluntness of sensibility of the hypothalamic cells and their~     Glucocorticoids Receptors type 2. Actually it seems that these phenomena are included in a~     diversion of the cortisol's action. From a function of acute stress management, with~     short-time exposures, the cortisol become one of the factors increasing an allostatic load,~     or resulting of this increase, maintaining a permanent state of stress, an inertia delay to~     adaptation and facilitating the emergence of psychiatric disorders.~      This lack of function can be estimated by the Dexamethasone Suppression Test (DST) which, by~     stimulation attempting of feedback mechanisms by Dexamethasone (which has cortisol-like~     properties), can show a non-suppressor population with HPA bluntness. If this biological~     feature isn't a biological marker of depression, because of a lack of specificity and~     sensibility, is notably associated with a poor outcome and higher risks of suicidal behaviors~     and pharmacological resistance.~      Many studies have explored possibilities of action on the HPA to treat depression or improve~     antidepressant specific therapeutics, with inconstant results. One of the most promising~     molecule seems to be Metyrapone, a reversible inhibitor of the 11ß-hydroxylase enzyme which~     transform desoxycorticosterone and 11deoxycortisol to respectively corticosterone and~     cortisol. There have been several open label studies which aim to explore the possibility of~     an effect of the combination between Metyrapone and antidepressant molecules. This led to two~     randomized double blind controlled versus placebo studies whose conclusions are divergent.~      These conclusions and their heterogeneity lead to think that there is a sub-population which~     could be better responder to this type of association. Physiopathological knowledges and~     preliminary observations in DST non-suppressor population by using anti-glucocorticoids~     therapies , makes it possible to consider possible that responsive sub-population can be~     defined by the feature  DST non-suppressor .~   "
5744|NCT03491683|"~     Phase 1/2 trial to evaluate safety, immunogenicity and preliminary efficacy of INO-5401 and~     INO-9012 in combination with cemiplimab (REGN2810), with radiation and chemotherapy, in~     subjects with newly-diagnosed glioblastoma (GBM).~   "
5745|NCT03491670|"~     Out of hospital cardiac arrest is associated with a poor prognosis. The aim of this study is~     to provide a better understanding of perturbations of iron metabolism after cardiac arrest~     and to analyze the impact on clinical centered outcome.~   "
5746|NCT03491657|"~     Many children with large severe burns report severe pain during burn wound cleaning. The~     current study explores whether adjunctive immersive Virtual Reality distraction may help~     reduce the intensity of pain experienced by children during burn wound cleaning by taking the~     patient's mind off their pain.~   "
5747|NCT03491644|"~     The objective of this trial is to investigate whether treatment with oxygen in the early~     phases after a trauma plays a role in recovery.~   "
5748|NCT03491631|"~     This phase I trial is designed to efficiently identify the dose-limiting toxicity (DLT) and~     maximum tolerated dose (MTD) for the combination therapy regimen of the IDO1 inhibitor~     SHR9146 when administered in combination with immune checkpoint PD-1 inhibitor SHR-1210 plus~     VEGFR inhibitor Apatinib or not in subjects with advanced/metastatic solid tumors. All~     subjects will receive the same standard SHR-1210 plus Apatinib (only three drugs~     group)regimen, while SHR9146 in doses increasing from 100 mg twice daily to, potentially, 600~     mg twice daily. Once the recommended regimen has been identified, subjects with the selected~     tumor type will be enrolled into expansion cohorts based upon prior safety and tolerability~     data.~   "
5749|NCT03491618|"~     Prospective study to analyse pain reduction with two types of canulae and two types of~     placements for lumbar medial branch radiofrequency denervation.~   "
5750|NCT03491605|"~     Immunocompetent subjects with high load of Epstein-Barr virus DNA (EBV-DNA) in peripheral~     blood will be enrolled and prospectively followed up to track the natural histories of the~     chronic high load of EBV virus. The primary goal of this study is to explore the association~     of peripheral high load of EBV with the hematological malignancies, and second goal is to~     investigate the genetic mechanisms of immune escape and tumorigenesis of chronic EBV~     infection.~   "
5751|NCT03491592|"~     This renewal builds upon our successful culturally adapted PA intervention for Latinas (Pasos~     Hacia La Salud, R01CA159954) and expands its focus to the critical area of maintenance of~     behavior change. This study will test an enhanced version of the original internet~     intervention in order to achieve greater increases in PA and longer term maintenance.~     Investigators propose to test this newly developed enhanced intervention (Enhanced~     Intervention) compared to the original Pasos Hacia La Salud Intervention (Original~     Intervention) in a 24-month randomized trial (N=300).~   "
5752|NCT03491579|"~     This trial assess the maximum tolerated dose (MTD) and to characterize dose-limiting~     toxicities (DLTs) of epacadostat when added to the cladribine/cytarabine chemotherapy in~     relapsed / refractory AML patients fit for intensive treatment~   "
5753|NCT03491566|"~     The aim of this study is to investigate the effectiveness of Pilates-based exercises on~     cognitive functions in comparison with aerobic exercises.~      Individuals in the 8-weeks study will be divided into three groups using the e-picos~     website: Clinical Pilates exercise group (Group 1), aerobic exercise group (Group 2), control~     group (Group 3). The sample size for each group was calculated as 24 people. Considering the~     possibility of %10 drops, 27 individuals will be included in each group and a total of 81~     cases in the study.First, the socio-demographic information of the participants will be~     collected with a prepared form. Individuals will be assessed by the International Physical~     Activity Questionnaire-Short Form, Nelson Speed of Movement Test, Verbal Fluency Test and~     Stroop Test at pre-study,end of the first session, 4th week and end of the study (8th week).~     Participants in control will be given will keep an activity lo to check their physical~     activity levels. SPSS package programme will be used in the analysis of the data and p<0.05~     will be considered significant.~   "
5754|NCT03491553|"~     The primary objectives of this study are to evaluate the safety, tolerability and antiviral~     activity of multiple oral doses of GS-9688 in virally suppressed chronic hepatitis B (CHB)~     adults on oral antiviral (OAV) agents.~   "
5755|NCT03491540|"~     This study aims to demonstrate that a preoperative combination of mechanical bowel~     preparation and oral antibiotics, before elective laparoscopic rectal cancer surgery, is~     associated with a reduction of postoperative surgical site infection rate, as compared to~     mechanical bowel preparation alone Our hypothesis is that a preoperative colonic preparation~     including a combination of mechanical bowel preparation and oral antibiotics before elective~     laparoscopic rectal cancer surgery is associated with a reduced rate of 30-day postoperative~     surgical site infection, as compared to mechanical bowel preparation alone~   "
5756|NCT03491527|"~     The aim of this study is through a randomized clinical trial, double blind, splithmouth,~     evaluate the success rate (post or dental crown displacement; fracture of the~     core/post/crown; marginal integrity and absence of endotontic alterations) of definitive~     indirect crowns un endodontically treated teeth. The composition of the resin cement (with~     and without mineral trioxide aggregate) will be evaluated. Data will be collected, tabulated~     and submitted to statistical analysis.~   "
5757|NCT03491514|"~     The objectives of this study are to examine the blood glucose and serum insulin response~     elicited by servings of Test Granola and Control Granola containing equal amounts of~     available carbohydrate over a 3 h time period. In addition, the subjective hunger response to~     these foods will be measured over 3 h.~   "
5758|NCT03491501|"~     The main aim of the project is to evaluate a novel upper body exoskeleton during simulated~     industrial work. In a first stage of the project, an extensive study involving the end-user~     companies will be carried out to clearly identify the operator target tasks and typical~     target task loads for which the exoskeleton will be designed. Based on standard ergonomic~     evaluation scales (RULA and NIOSH, the Need for Recovery Scale and the Ovako Working Posture~     Analysing System), high risk tasks will be identified in the field, based on the evaluated~     information about the workspace configuration, the performed operations and their physical~     constraints. These will include, but will not be limited to, non-ergonomic postures, for~     example performing operations above the head or reaching in front, to the side, or behind the~     body; flexing the arms for extended periods of time; and bending or twisting the torso to~     lift an object from low or distant locations. Important items to assess in this task are the~     frequency and duration of tasks and activities, lifting characteristics, perceived physical~     effort and work-induced fatigue.~   "
5768|NCT03491371|"~     Anti-angiogenesis Tyrosine kinase inhibitors (TKIs) have been proved to show promising~     effects on prolonging progression-free survival (PFS) for advanced sarcoma after failure of~     standard multimodal Therapy. Methylsulfonic apatinib is one of those TKIs which specifically~     inhibits VEGFR-2. This study summarizes the experience of three Peking University affiliated~     hospitals in off-label use of apatinib in the treatment of extensively pre-treated sarcoma.~   "
5769|NCT03491358|"~     This study will assess the Aerogen Solo® (Solo®) vibrating mesh nebulizer as a potential new~     device for use in allergen challenge testing.~   "
6382|NCT03483311|"~     • Assessment of tissue level of resolvin D1 in psoriasis in comparison to its level in~     healthy controls in order to verify its role in the pathogenesis of psoriasis.~   "
5759|NCT03491488|"~     A growing body of research has highlighted the critical importance of children's~     self-regulation and executive function skills for their school performance as well as for~     their later life outcomes. Starting around age three, children have a unique potential to~     improve these skills and establish positive behaviors that will support them in school and~     life.~      This project will adapt, implement and evaluate the effectiveness of the Brain Games~     intervention package as a tool to improve children's self-regulation and executive function~     skills. Brain Games were developed as part of larger behavioral intervention package in the~     US, and are designed to build the fundamental self-regulation skills that children need to be~     successful in school as well as later in life. The Brain Games curriculum will be adapted to~     Brazil, and evaluated through a 12 month randomized controlled trial with 60 crèches in São~     Paulo to assess its impact on children's self-regulation and executive functioning skills.~   "
5760|NCT03491475|"~     In this study the investigators analyse echocardiographic images before and during Ajmaline~     test. The purpose is to know if any echocardiographic modifications are present during either~     negative or positive Ajmaline testing.~   "
5761|NCT03491462|"~     A multicenter, randomized, double-blind, placebo-controlled, parallel group trial to evaluate~     the efficacy and safety of arimoclomol in amyotropic lateral sclerosis (ALS)~   "
5762|NCT03491449|"~     Demonstrate that maintenance of systolic blood pressure between 140 and 160 mm Hg during the~     acute phase of ischemic stroke is more effective than management according to the~     International Guideline (treat when systolic blood pressure exceeds 185 mm Hg)~   "
5763|NCT03491436|"~     Background: Remote monitoring (RM) is a new screenings- and or diagnostic tool in healthcare.~     In 2015, the PREMOM study (Pregnancy Remote Monitoring), in which patients with gestational~     hypertensive diseases did received a RM prenatal follow up, has started. The first results~     showed an added value of RM in the prenatal follow-up. Due to these results, a RM program for~     pregnant women with gestational diabetes mellitus (GDM) will be developed and evaluated.~      Protocol: Women (at risk of) GDM will be included in this study. They receive a iHealth Align~     (a glucose monitor) and associated glycemiestrips. The app of iHealth will be downloaded on~     the pregnant women's Smartphone to collect the data and to send them to the researcher in the~     hospital.~      The women is asked to perform four glycemie controls/day (sober and two hours after every~     mail) with the received glucose monitor. The monitor is connected via Wi-Fi and Bluetooth~     with the computer of the researches who controls and evaluated these data. Additionally, the~     pregnant women has to check daily her body weight with a weight scale of her own. They have~     to upload these data manually in the app on her smartphone.~      When the pregnant women has an prenatal consultation, an overview with the data will be send~     to the responsible gynecologist. The gynecologist will also be alarmed when the pregnant~     women has three abnormal values at the same moment of the day (ex. Every morning after~     breakfast). When necessary, advice among life-style can be given or a referral to an~     endocrinologist can be made. The researches will not perform interventions by herself, only~     the responsible doctor can do this.~      By analyzing the patients parameters when she's at home, a better vision can be achieved of~     the health of the mother and the child. This study will be conducted as a first research to~     get a better insight in the added value of RM in pregnancies complicated with GDM.~   "
5764|NCT03491423|"~     Recommendations for cardiovascular rehabilitation (CVR) encourage exercise training,~     primarily involving the aerobic system, to allow patients to regain independence in daily~     activities. However, the lactic anaerobic process is also involved during these activities~     (stair climbing, carrying loads, etc.). Hence there is a major interest in accurately~     assessing patients' anaerobic capacities in order to tailor suitable exercise programs.~     However, there are no functional tests specifically dedicated to the evaluation of lactic~     anaerobic metabolism and adapted to people with coronary disease. The investigators offer a~     dedicated test, the short and fast test (SFST), which can be applied in current clinical~     practice and has already been evaluated in a population of healthy subjects. The purpose of~     this project is to evaluate the safety, feasibility and validity of SFST in a population of~     patients with coronary artery disease.~   "
5765|NCT03491410|"~     Experimental, clinical, and epidemiological studies have all demonstrated the strong~     association between chronic inflammation and cancer, and many studies have correlated the~     prolonged presence of the inflammatory milieu with an increased risk for developing~     cancer.(1) Although the potential mechanism for aspirin preventing breast cancer is not~     known, possible pathways may involve platelets, inflammation, cyclooxygenase (COX) 2,~     hormones, or PI3 kinase. (2).~      In actual clinical practice there exist clear guidelines for the use of aspirin in colorectal~     cancer but no such guidelines exist for the use of aspirin in breast cancer patients.~      In the Unit´s proper experience, in patients under active surveillance and metastatic ones~     some present very good responses both in the neoadjuvant and in the metastatic setting but~     investigators intend to provide evidence and not just the experience. This study patients are~     proposed to combine their standard treatment with aspirin.~   "
5766|NCT03491397|"~     The purpose of this clinical research study is to examine whether Embozene treatment of the~     genicular artery is a safe and effective way to treat arthritic knee pain. Embozene is a~     medical device made by Boston Scientific approved in the United States for the treatment of~     hypervascular tumors and arteriovenous malformations. It consists of thousands of microscopic~     spheres that are injected into the artery in the knee going to the region of pain. One of the~     causes of pain in the setting of knee arthritis is increased blood flow going to the specific~     area of pain. The goal of this procedure is to decrease the blood flow (embolize) to the~     specific region of the knee that is causing your pain. This is done by infusing Embozene~     particles into the specific blood vessel (genicular artery) supplying the area of pain in the~     knee.~   "
5767|NCT03491384|"~     This study investigates whether the anxiolytic effects and anti-inflammatory properties of~     cannabis vary as a function of the ratio of CBD to THC, with the goal that these effects may~     shed light on the mixed data linking cannabis use and anxiety. Individuals with mild to~     moderate anxiety who elect to use cannabis (smoked flower or edible) will complete four weeks~     of observation. Participants complete cognitive tasks, a substance use history, health~     questionnaires concerning sleep and physical activity, and a blood draw at four different~     time points (Baseline, after 2 weeks of cannabis use, and immediately before and after~     self-administration after 4 weeks of use) with the use of a mobile pharmacology laboratory,~     which goes to a convenient location for each participant to self-administer their cannabis.~     Participants are then followed for five months to self-report on cannabis use, anxiety,~     subjective cognitive functioning, sleep quality, and other mental health symptoms.~   "
5992|NCT03488433|"~     To compare the functional and anatomical outcomes, and patient satisfaction and compliance~     between two different postoperative immobilization methods - abduction shoulder brace versus~     simple arm sling - following 2 common shoulder surgical procedures - rotator cuff repair~     (RCR) and reverse total shoulder arthroplasty (RTSA) through a prospective randomized~     clinical trial.~   "
5770|NCT03491345|"~     Investigators have conducted K-BASKET trial (Korea-Biomarker-driven multi-arm drug-screening,~     knowledge and evidence-generating targeted trial), which was based on the specific genetic~     aberration, not the cancer type, which could accelerate matching the right drug to the right~     target so that every cancer patient could get the right specific drug based on the specific~     genetic biomarker, like NCI-MATCH trial. Next generation sequencing (NGS) focusing panel has~     the mutation and copy number variation of MET, PIK3CA and AKT. Investigators will open new~     treatment arms during the progress of K-BASKET trial. Patient with PD-L1 positive or EBV~     positive or MSI-H or POLE/POLD1 mutation tumor will be assigned to Avelumab monotherapy.~   "
5771|NCT03491332|"~     Mechanical respiration during general anesthesia causes cold and dry gases to reach the lower~     airway, reduce the function of the airway mucosa, and cause accumulation of secretions.~     Inhaled dry gas is one of the causes of hypothermia during general anesthesia. To overcome~     this, the warm-humidifying breathing circuit uses warm, moisture-preserving gas to promote~     mucus mobility of the airway mucosal ciliate cells and prevents cold gases from evaporating~     from the mucosal surfaces which results lowering body temperature. We aimed to investigate~     the effect of newly developed Sohum warm humidifying respiration circuit (SH501) on the~     prevention of core body temperature reduction during surgery and systemic inflammation~     reaction.~   "
5772|NCT03491319|"~     Subarachnoid block has become an established and reliable method of providing anaesthesia for~     lower abdominal and lower limb surgeries. Several factors determine the spread of local~     anaesthetic solutions in CSF. Among them, patient position is an important determining~     factor. Anesthesiologists give various degrees of head down tilt which they believe is both~     safe for the patient and will result in adequate level of block. Often these are arbitrarily~     done by the operator as most of the operation theatre tables are not equipped with any device~     to measure the accurate degree of tilt. As there is no agreement on the effect of~     Trendelenberg position on height of subarachnoid block, the current clinical study will be~     undertaken to estimate the effect of operation theatre table tilt at the time of lumbar~     puncture on the height of subarachnoid block.~   "
5773|NCT03491306|"~     This study evaluate Microbial growth on Bre-Flex versus PEEK denture base in Bilateral~     Maxillary bounded partial denture , half of patients will receive a framework with breflex~     denture base and the other half will receive a framework with PEEK denture base then evaluate~     the Candida growth~   "
5774|NCT03491293|"~     CHAT is an internet-based weight loss research program designed for women with overweight or~     obesity who want to lose weight through dietary change and increased physical activity.~     Participants will be randomized into a group-based online program who meet via a text chat or~     a video chat.~   "
5775|NCT03491280|"~     The DiRiP study will enroll patients (n = 3500) with unclear rare diseases and suspected~     genetic reasons. In group 1 (n = 500) subjects are clinically characterized in the context of~     outpatient/ inpatient standard care at the UKT or cooperating location, NGS analyzes and~     other omics analyzes (transcriptomics, proteomics, metabolomics), functional cell biology~     studies will be performed. In group 2 diagnostics is already performed.~   "
5776|NCT03491267|"~     The investigators have extensive evidence in mouse that wounding leads to the generation of~     new hair follicles in the skin. This can be an important new therapy for patients with~     scarring, but especially those with alopecia.~      The question is whether gentle wounding in human subjects can cause the generation of a new~     hair follicle.~      The plan is to first carefully map a small area of the scalp without hair follicles.~     Investigators will then try various modalities of gentle wounding (including fractionated~     Carbon Dioxide (CO2) laser, mild curetting) of the surface epithelium in the presence and~     absence of FDA approved topical medications (including retinoids). Investigators will then~     prospectively monitor the area for hair growth both by noninvasive visual monitoring~     (including photographs and dermoscopy) and biopsies.~      The outcomes of this study hopefully will allow new therapies for especially scarring~     alopecia conditions where hair follicles are completely lost and there are no current~     therapies.~   "
5777|NCT03491254|"~     This study is designed to evaluate the efficacy and safety of the combination treatment of~     Huaier granule and biliary drainage for malignant obstructive jaundice.~   "
5778|NCT03491241|"~     In obese patients the superficial adipose tissue works as an endocrine active tissue to~     express different cytokines, and multiple molecular pathways implied in the cross talking~     with different part of the human body, such as the cardiovascular system. To date, adipocytes~     and adipose tissue-derived macrophages and adipose tissue synthesize, and secrete several~     cytokines, and sirtuins. In this setting, the excess of body fat is linked to heart~     contractile dysfunction. All these pathways are differently expressed in obese diabetic~     patients as compared to obese non diabetic patients. Intriguingly, in diabetic obese patients~     the hyper-expression of inflammatory cytokines is associated to a hypo-expression of~     sirtuins. Therefore, this molecular pattern in diabetic obese patients may correlate to~     altered myocardial performance, and to the development of heart failure disease. In this~     study authors will evaluate at baseline by peripheral blood samples and by the abdominal fat~     tissue, the expression of cytokines and sirtuins comparing pre-diabetics obese patients vs.~     non pre-diabetics obese patients.~   "
5779|NCT03491228|"~     Secondary Data Collection Study; safety and effectiveness of Anaemetro under Japanese medical~     practice~   "
5780|NCT03491215|"~     The study is an open-label, single-arm, Phase I/II multi-center study to investigate the PK,~     activity and safety of ruxolitinib added to the patient's immunosuppressive regimen in~     infants, children, and adolescents ages ≥28 days to <18 years old with either grade II-IV~     aGvHD or grade II-IV SR-aGvHD. This trial will utilize age groups: Group 1 includes patients~     ≥12y to <18y, Group 2 includes patients ≥6y to <12y, Group 3 includes patients ≥2y to <6y,~     and Group 4 includes patients ≥28days to <2y.~   "
5816|NCT03490747|"~     The study will evaluate the effectiveness of a co-developed exercise referral scheme.~     Participants will be recruited to one of three groups 1. Co-developed exercise referral~     scheme, 2. Usual care exercise referral scheme, 3. No treatment control (no intervention).~     The study will measure effectiveness by observing change in cardiorespiratory fitness at 6~     months follow-up. Intervention cost-effectiveness will also be evaluated.~   "
5817|NCT03490734|"~     The proposed project will examine the strength, specificity and persistence of~     neurobehavioral adaptions that occur in the initial period of repeated consumption of a~     branded sugar sweetened beverage (SSB).~   "
5781|NCT03491202|"~     Atrial fibrillation (AF) is reaching epidemic proportions in the aging U.S. and European~     populations, but the mechanisms of increased susceptibility to atrial fibrillation are still~     unknown. In this study, we look to further examine genetic and medical co-morbidity influence~     of atrial fibrillation duration and response to medications. In Specific Aim 1, we propose~     the creation of a Veterans Affairs AF Biorepository (VAAFBio), which is a resource that will~     collect and store clinical, demographic, blood and DNA samples from patients with atrial~     fibrillation to aide this study and future studies of this type in the VA population. In~     Specific Aim 2, examine common genetic polymorphisms in veteran patients with atrial~     fibrillation and examine gene-environment interactions with risk factors for atrial~     fibrillation.~   "
5782|NCT03491189|"~     This study evaluates the rate of cut-out and fixation failures in helical blade fixation~     versus lag screw fixation for cephalomedullary nailing of peritrochanteric femur fractures.~   "
5783|NCT03491176|"~     The goal of this research study is to find out if using additional MRIs and biomarker testing~     can help researchers learn to predict how the tumor may change during radiation therapy.~      Biomarkers are found in the blood/tissue and may be related to participant's reaction to~     treatment. Biomarker testing in the study may include genetic biomarkers.~      This is an investigational study. MRIs on this study are performed using FDA-approved and~     commercially available methods. Having added scans and blood tests is investigational.~      Up to 100 participants will be enrolled in this study (up to 80 patients and up to 20 healthy~     volunteers in another part of the study). All will take part at MD Anderson.~   "
5784|NCT03491163|"~     Evaluation of endothelial glycocalyx damage in on-pump conventional coronary artery bypass~     surgery using a syndecan-1 (CD138) blood test. The study will be carried out in two stages.~     Pilot study for testing and correcting research methodology and the main study.~   "
5785|NCT03491150|"~     In the BN40031 OLE study, a dose of crenezumab of 60 mg/kg IV Q4W will be offered to all~     patients who complete Study BN29552 or BN29553 and who meet eligibility criteria in order to~     evaluate safety in patients on long-term crenezumab treatment and to investigate the effect~     of crenezumab on the underlying disease process and disease course as an exploratory efficacy~     objective.~   "
5786|NCT03491137|"~     A high percentage of patients undergoing major abdominal surgery will develop a postoperative~     complication. Our hypothesis is that by observing postoperative patients with continuous~     wireless monitoring, it is possible to detect the correlation between deviating vital~     parameters and subsequent postoperative complications. A prospective observational study will~     take place on general surgical wards with the enrolment of 500 patients in two different~     hospitals. Physiological parameters will be recorded for 96 hours postoperative. Data is~     collected preoperative, peroperative and postoperative in up to 6 months for data analyzing.~   "
5787|NCT03491124|"~     The purpose of this study is to determine the effect of Battlefield Acupuncture (BFA) on~     outcomes for pain, sleep, and physical activity level in an active duty military sample with~     subacute or chronic lower back pain (LBP). BFA is a form of auricular acupuncture (AA) that~     has been implemented in many Department of Defense (DoD)/Veterans Affairs (VA) medical~     settings to alleviate acute or chronic pain. BFA uses five predetermined locations in a~     defined sequence to place semi-permanent needles in the ear. Subacute lower back pain is pain~     that has persistently lasted from four to twelve weeks. Chronic lower back pain is pain that~     lasts more than 12 weeks.~      Hypothesis 1: Participants with subacute or chronic LBP will have reduced pain using BFA as~     compared to placebo.~      Hypothesis 2: Participants with subacute or chronic LBP will have improved physical activity~     using BFA as compared to placebo.~      Hypothesis 3: Participants with subacute or chronic LBP will have improved sleep quality as~     compared to placebo.~      The secondary study aims are:~        1. To explore the effects of BFA two weeks following the treatment for LBP.~             1. Do positive outcomes appreciated with BFA persist over two weeks?~             2. What is the pain medication usage during and after intervention treatments?~        2. To explore the effectiveness of BFA on trunk flexion mobility and balance.~             1. Does pain reduction improve trunk flexion and balance?~             2. Does improved truck flexion mobility and balance contribute to increased physical~               activity?~   "
5788|NCT03491111|"~     Stroke survivors commonly have respiratory muscle weakness, swallowing disturbance, general~     weakness, reduced the daily living activities and short of motivation for rehabilitation.~     Respiratory muscle training (RMT) has been reported to improve the pulmonary function,~     respiratory muscle strength, exercise capacity, sensation of dyspnea and quality of life in~     several diseases, but rare in stroke patients. Reviewing previous reports, the protocol,~     intensity and duration of respiratory muscle training is still variable.~      Purpose: To investigate the feasibility and efficacy of respiratory muscle training on~     cardio-pulmonary function, swallowing function, cough function and reduction of incidence of~     pneumonia in post-stroke patients.~      Methods: A prospective, single blinded, randomized study. Consecutive patients with diagnosis~     of stroke will be proved by magnetic resonance image or computerized tomography. Stroke~     patients, aged 35-80 years old, with inspiratory muscle weakness or swallowing disturbance~     will be enrolled and randomly divided into control group (usual rehabilitation alone) and~     experimental group [inspiratory muscle training (IMT) group for patients with inspiratory~     muscle weakness and expiratory muscle strengthening training (EMT) for patients with~     swallowing disturbance]. Each patients will receive usual rehabilitation.~      The investigator expect that RMT will be practical for the restoration of respiratory muscle,~     swallowing function, cough function and voice quality, thereby reduction of the incidence of~     pneumonia.~   "
5818|NCT03490721|"~     This crossover design experimental study aims to compare the physiological stability of~     premature newborns during and after a cluster of care compared to a period when they receive~     standard non clustered care at the neonatal unit.~   "
5819|NCT03490708|"~     56 participants with Mucinoses will be selected to receive treatment of tranilast. After a~     period of time ,the investigators can determine the efficacy of the drug by detecting the the~     thickness and area of skin before and after treatment.~   "
5993|NCT03488420|"~     The objective of this registry is the characterization of patients with atrial fibrillation~     (AF) with confirmed valvular heart disease (VHD) who are prescribed edoxaban in a real-life~     clinical setting.~   "
23230|NCT03262896|"~     This study examines muscle movements of elecromyography in adults with brain death. Half of~     the participants will have brain death, the other half will be healthy volunteers.~   "
5789|NCT03491098|"~     Otitis media with effusion (OME) is defined as effusion in the middle ear without signs and~     symptoms of an acute infection. It is a leading cause of hearing impairment in children, and~     its early and proper management can avoid hearing and speech impairment, which can cause~     developmental delay in children.Although many conditions such as enlarged adenoids, cleft~     palate, Down syndrome, Kartagener syndrome, and nasopharyngeal neoplasm are related to the~     role of eustachian tube (ET) dysfunction in the pathogenesis of OME, allergic, immunologic,~     and infectious factors have also been claimed. Treatment of OME is still a controversial~     issue, as conventional treatment approaches fail to provide satisfactory and permanent relief~     of otologic symptoms.There is lack of proven effectiveness of the commonly given treatments,~     such as antibiotics, decongestants, and antihistamines, which are potentially harmful and~     have disadvantages. Few in those studies,investigated topical intranasal steroid for OME~     treatment,and in those studies, the duration of intranasal steroid application was short and~     there was no hearing evaluation.~   "
5790|NCT03491085|"~     morbidity after tonsillictomy remains asignificant problem therefore they recommend~     prophylactic antibiotics to reduce it.in the other hand, the overuse of antimicrobial agents~     can lead to antimicrobial resistance ,adverse drug events,and unnecessary cost.so,the~     effectiveness and necessity of antibiotic following tonsillictomy needs to be studied .~   "
5791|NCT03491072|"~     This study evaluates pain relief during extracorporeal shock-wave Lithotripsy by using~     transcutaneous electrical nerve stimulation (TENS) and comparing it with fentanyl which is a~     narcotic analgesic. Half of the participants will receive a primary fentanyl dose together~     with TENS application, another half will receive a primary fentanyl dose. All patients will~     receive fentanyl increments if they still complained of pain.~   "
5792|NCT03491059|"~     The investigators aim to (1) establish a methodology for the evaluation of the~     biodistribution of radio-labeled nicotine following e-cigarette use, (2) determine the~     oral/pulmonary distribution of nicotine following e-cigarette use, and (3) determine the~     lowest required dose using the new digital PET/CT technology to provide detailed or accurate~     oral/pulmonary distribution data following e-cigarette use. Potential participants will be~     identified using advertisements such as brochures and online social media postings. After~     participants are identified, their eligibility will be determined using survey tools. All~     eligible participants will first have a screening visit at the WCIBMI for study~     participation. During this initial visit, subjects will be informed about the study in~     detail, and the relevant consent form will be reviewed and signed. If the participant agrees~     to participate, they will go through a full dress rehearsal. Up to 10 volunteers will only~     participate in the dress rehearsal. All other volunteers (30) will have a dress rehearsal~     without radiation exposure on day 1, and then on a second day, they will participate in the~     full imaging study using 11C-nicotine. During the imaging study, S-nicotine will be labeled~     with 11C and placed in the cartridge of an e-cigarette. There will be two dose groups: (A) 3~     mCi dosage or (B) 9 mCi doses. The investigators intend to use dose level A; however, if it~     does not lead to the expected results, an alternate dose level as an option is needed, which~     is the 9 mCi (B) dose level. Subjects will take a maximum of 10 puffs (1 puff per 30 seconds)~     from the e-cigarette while positioned in the PET/CT system. Dynamic PET/CT imaging will be~     performed for a maximum of 60 minutes following inhalation. The subject will be placed in the~     PET camera in order to generate axial images of the following regions: head/neck (e.g.,~     brain, oral cavity, and throat) and thorax (e.g., trachea, lungs). From the PET/CT images,~     quantitative radioactivity deposition will be determined, and the biodistribution and~     uptake/clearance will be evaluated. PET data will be acquired in listmode and subsequently~     used for simulation to determine the potentially lowest dose feasible using the next~     generation digital PET/CT technology.~   "
5793|NCT03491046|"~     The objective of this study is to answer the following questions:~        1. Does the appearance of the reconstructed anterior cruciate ligament (ACL) vary in~          appearance on PET/MRI depending on graft type and time after surgery?~        2. What is the appearance of the native ACL on Positron Emission Tomography/Magnetic~          Resonance Imaging (PET/MRI)?~   "
5794|NCT03491033|"~     Tumor response to NAC predicts survival and can be considered a surrogate prognostic marker.~     Three tiered chemotherapy response score (CRS) of omental tissue sections showed a~     significant association with survival. In patients with CRS 1 or 2, NAC selects a~     subpopulation of chemotherapy resistant tumor cells. This study will examine comprehensive~     molecular analyses on the residual disease of 104 clinically defined high-grade serous~     carcinoma after NAC, including next-generation sequencing on 14 matched pretreatment~     biopsies. This information together with immune marker expression and BRCA expression, will~     provide a unique opportunity to guide biomarker-driven adjuvant studies targeting these~     chemotherapy-resistant tumor cells.~   "
5795|NCT03491020|"~     Airborne transmission represents one of the most rapidly spreading and dangerous~     dissemination mechanisms for pathogens. Public health strategies to prevent and control the~     often explosive outbreaks associated with such pathogens are: 1) vaccination and treatment,~     if available, 2) isolation and barrier precautions such as face masks, and 3) decontamination~     of the exposed areas and surfaces. A lack of understanding how these pathogens are~     transmitted hampers the ability to develop effective prevention measures. This study will be~     used to collect preliminary data of the emission patterns of respiratory pathogens.~   "
5796|NCT03491007|"~     The purpose of this research is to determine if a study medication called~     Dehydroepiandrosterone (DHEA) helps to reduce PTSD symptoms in OEF/OIF/OND Veterans. In~     addition to finding out if DHEA is effective for treating PTSD symptoms, this research seeks~     to determine if DHEA is effective in treating other symptoms, such as depression and anxiety.~     Depression and anxiety are symptoms that are frequently present in Veterans who are~     experiencing PTSD. Another purpose of this research is to takes pictures of the brain using~     magnetic resonance imaging (MRI) and blood levels of various small molecules including~     neurosteroids and also proteins, which may be affected by the study drug and/or related to~     symptoms in Veterans with PTSD. This study seeks to determine if DHEA is changed to other~     compounds after it is taken by mouth and the safety and effectiveness of DHEA in Veterans~     with PTSD. This is an add-on study and Veterans enrolled in the study will continue to take~     all of their current medications without any changes (also called usual care), and DHEA or~     a sugar pill (also called a placebo) will then be added to their current medication~     regimen.~   "
5820|NCT03490695|"~     Uptake of a community-based evidence-supported interventions for hypertension control in~     Ghana are urgently needed to address the cardiovascular disease epidemic and resulting~     illness, deaths, and societal costs. This study will evaluate the effect of Practice~     Facilitation on the uptake and maintenance of the evidence-based task-shifting strategies for~     hypertension control (TASSH) protocol across 70 Community-based Health Planning and Services~     (CHPS) zones delivered by trained community health officers.~      Findings from this study will provide policy makers and other stakeholders the how to do it~     empirical literature on the uptake of evidence-based interventions in Ghana, which may be~     applicable to other low-income countries.~   "
8560|NCT03454828|"~     The overarching goal of this project is to determine whether the effect of gut microbiota on~     human metabolism might be mediated by short chain fatty acids (SCFA) and whether the SCFA~     might modulate lipid metabolism.~   "
5797|NCT03490994|"~     Vitamin K antagonists (VKAs) are used to reduce the risk of stroke (cerebral vascular~     dysfunction) in AF patients. However, VKAs interact with drugs/food and the drug level is~     influenced by worsening of renal function, liver congestion or hemodynamic alterations in~     acute decompensated heart failure (ADHF). New oral anticoagulants (rivaroxaban, apixaban,~     dabigatran) are alternatives to VKA, such as warfarin. In post hoc analysis of ROCKET AF~     trial, 63.7% patients had HF and treatment-related outcomes were similar in patients with and~     without HF (Circulation HF. 2013; 6:740-7). So rivaroxaban 20 mg daily (or 15 mg daily in~     patients with creatinine clearance 30-49 mL/min) was safe in nonvalvular AF patients with HF.~     However, the clinical effect and safety of rivaroxaban were largely unknown in acute~     decompensated heart failure (ADHF) patients with atrial fibrillation (AF).~      ROAD HF-AF is the exploratory study to assess the change of surrogate markers (hsTn, d-dimer)~     when treated with rivaroxaban vs. warfarin and to strengthen the basis for future~     biomarker-based therapy in ADHF patients~   "
5798|NCT03490981|"~     To address the gap in treatment options for Veterans with chronic pain in primary care, the~     investigators have developed an abbreviated version of cognitive behavioral therapy, Brief~     Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP), specifically for use in~     integrated care settings. The first objective of the proposed study is to conduct a pilot~     randomized controlled trial of Brief CBT-CP compared to primary care treatment as usual to~     assess feasibility (i.e., recruitment and retention of participants, appropriateness of~     measures, and assessment of fidelity of service delivery). This trial will also preliminarily~     assess treatment effectiveness by examining changes in pain-related physical interference,~     psychological distress, pain intensity, and other related outcomes. Thirty eligible~     participants will be randomized into either Brief CBT-CP and primary care treatment as usual~     or primary care treatment as usual only. Eligible Veterans will include those with chronic~     musculoskeletal pain and pain-related functional impairment identified from primary care.~     Participants assigned to Brief CBT-CP will receive six weekly sessions of treatment in~     30-minute appointments. This intervention will include education and goal setting, activities~     and pacing, relaxation skills, cognitive coping, and relapse prevention. Assessments will~     include validated self-report measures that will take place at pre-treatment (baseline),~     post-treatment, and at 12-week follow-up. The second objective of this study will be to~     explore patient and provider perceptions of Brief CBT-CP to identify potential modifications~     that will improve its quality and overall feasibility of delivery in future work.~     Participants will include up to 12 staff members as well as up to 12 patients who were~     randomized to Brief CBT-CP. Participants will be interviewed by telephone about key~     components of the treatment. Participants will comment on the protocol and study procedures~     in terms of acceptability (the perception that a treatment is agreeable or that its specific~     components are satisfactory), appropriateness (the perceived fit or compatibility of the~     intervention for a given provider or consumer), and feasibility (the extent to which a new~     treatment can be successfully carried out or is suitable for everyday use). This intervention~     has been designed specifically for integrated care providers and therefore has clear~     implications for translation to clinical practice and for improving pain care quality by~     providing an evidence-based protocol. The potential direct benefit to Veterans includes~     offering a safe, accessible, non-pharmacological treatment for chronic pain early in the~     trajectory of VA care.~   "
5799|NCT03490968|"~     Test the theory that abnormalities in the large blood vessels that deliver blood to your leg~     and the very small blood vessels in your leg's muscles (invisible to the eye) work together~     to worsen your leg function and walking.~   "
5800|NCT03490955|"~     The objective of this project is to determine the extent to which eating black pepper~     together with vegetables increase the absorption of carotenoids (a class of important~     nutrients) in the vegetables such as beta-carotene.~   "
5801|NCT03490942|"~     This is a prospective, randomized, controlled, double-blind, parallel 4-group trial with the~     primary analysis after 4 weeks of treatment with continuous subcutaneous glucagon infusion~     (CSGI) or placebo. After a 1-week qualification on continuous glucose monitoring (CGM),~     subjects will have their baseline hypoglycemia counter-regulatory response hormones~     quantified using a step-wise hypoglycemia induction procedure. Subjects meeting eligibility~     requirements will be randomized to 1 of 4 treatment groups, 2 glucagon, 2 placebo. Subjects~     will receive blinded study drug for 4 weeks, and they will be followed for an additional 26~     weeks post-treatment. Subjects' counter-regulatory hormone response will be measured at~     baseline, the end of treatment (4 weeks), and 13 and 26 weeks after treatment ends.~   "
5802|NCT03490929|"~     Children with blunt abdominal trauma often get a CT as the first line imaging to evaluate for~     intra-abdominal organ injury. CT scans have some downsides with regard to radiation exposure,~     costs, and need for transport. Contrast enhanced ultrasonography has recently shown some~     promise as a way to detect intra-abdominal organ injury and may be able to replace the need~     for conventional CT scanning, without the need for ionizing radiation and the ability to be~     performed at the bedside.~   "
5803|NCT03490916|"~     The overall goal of this study is to detect preclinical signs of HAPE by lung ultrasonography~     and evaluate the effectiveness of acetazolamide at decreasing pulmonary edema by using~     ultrasound.~   "
5804|NCT03490903|"~     The CATH-VR study will investigate the effect of virtual reality (VR) on patient pain,~     anxiety, and radial artery vasospasm during coronary angiography. Our hypothesis is that the~     use of VR will decrease patient anxiety and pain via validated scoring systems, as well as~     show a low rate of vasospasm of the radial artery. In addition, we hypothesize that the~     amount of opioid and benzodiazepine medications utilized for procedural sedation will be~     lower in the intervention arm. VR has gained recent attraction as an alternative or~     adjunctive treatment option for pain, but its effect on reducing procedural sedation has not~     been studied. We propose a single center, randomized control pilot study to further~     investigate. The patient population will include adults older than 18 years who present for~     outpatient diagnostic coronary angiography.~   "
5805|NCT03490890|"~     GGO was commonly observed recently.Radiofrequency ablation has been widely applied in the~     treatment of patients with GGO. No study had explored the microwave ablation in the treatment~     of GGO.~   "
5806|NCT03490877|"~     Atopic dermatitis (AD) is a chronic type of eczema affecting approximately 10% of adults and~     12% of children in the US. The intense itching (pruritus) associated with AD can be~     significantly disruptive to sleep and quality of life for both the patients and their~     caregivers. AD is challenging to describe and measure. The purpose of this study is to see if~     we can reliably measure how much people with AD scratch and how scratching interferes with~     sleep and quality of life by using digital sensors, sleep studies and patient-reported~     information.~   "
5831|NCT03490552|"~     Introduction: the source of embolic stroke , in thrombotic embolism , is of unknown origin in~     30-40% of cases. Fortunately , Mechanical thrombectomy provide a direct method to retrieve~     the stroke-incriminated clots from stroke patients for possibility of exo-autopsy analysis.~   "
6002|NCT03488303|"~     The purpose of this study is to evaluate the association of signals recorded and analysed~     with Ventica® LFTS in infants and preschoolers during acute airway obstruction/asthma~     exacerbation and recovery thereof for changes in the IP-derived TBFV curves within and~     between nights.~   "
5807|NCT03490864|"~     There is a growing body of evidence from both laboratory and field studies that disrupted~     circadian function, particularly decreased amplitude and stability of rhythmic behaviors~     represent significant risk factors for cardiometabolic disease (CMD) in humans. The exciting~     evidence of the ubiquity of circadian clocks in all tissues and their critical role in~     metabolism, not only opens up new avenues for understanding the mechanistic interactions~     between central and peripheral clocks in cardiometabolic disease pathogenesis, but also to~     develop therapeutic interventions to re-establish synchrony between central and peripheral~     clocks with each other and with the external physical and social environments. Feeding has~     been shown to synchronize clocks in peripheral tissues. Animal studies have demonstrated that~     restricting feeding to the active period decreases CMD risk, while in humans decreased~     caloric intake in the evening is associated with a lower body mass index (BMI). The amplitude~     of melatonin can be considered a marker of robustness of central circadian function, but~     melatonin also has physiological effects beyond circadian regulation throughout the body.~     Recent observations have demonstrated that having a low melatonin level is a risk factor for~     incident diabetes and hypertension independent of sleep duration. Together, the evidence~     suggests that strategies aimed at synchronizing feeding behavior and enhancing the nocturnal~     melatonin signal can positively impact cardiometabolic function.~      We propose to take an innovative approach that combines the recent data on the role of~     feed/fast patterns on clock regulated metabolic activity and the reemergence of scientific~     interest of the central and peripheral effects of melatonin on cardiometabolic function to~     elucidate the physiological and molecular mechanisms that underlie the relationship between~     circadian dysregulation and obesity associated CMD risk. This will be accomplished by~     strengthening the amplitude of circadian metabolic signals via meal timing and enhancement of~     nocturnal circadian signaling with exogenous melatonin in overweight and obese middle aged~     and older adults. In addition, this study will provide crucial information regarding the~     importance of circadian timing for the design of future clinical trials on CMD in overweight~     and obese adults. This is a critical time in the lifespan when circadian based strategies for~     prevention and treatment are most likely to have the greatest impact on CMD risk. This~     project will enroll 100 adults (40-54 years) to participate in a parallel (4 arm~     intervention) placebo controlled study to determine whether a six- week program of meal~     timing and/or low dose (3 mg) melatonin administration will enhance circadian amplitude and~     enhance cardiometabolic function, as well as to evaluate the potential beneficial effects of~     a regimen that combines both approaches. The results from this study will demonstrate novel~     mechanistically based approaches for maintaining and improving circadian-metabolic health~     during a critical time in the lifespan when there is a rapid increase in the prevalence of~     CMD.~   "
5808|NCT03490851|"~     The objectives of this study are to determine, in normal-weight and overweight subjects the~     effect of: Primary: oatmeal containing 4 g oat β-glucan on food intake at a subsequent meal~     compared to Cream of Rice cereal. Secondary: (i) oatmeal containing 2 g oat β-glucan on food~     intake at a subsequent meal compared to Cream of Rice cereal; and (ii) oatmeal containing 2g,~     4g and 4g low MW oat beta-glucan on subjective appetite ratings, gastric emptying,~     postprandial responses of glucose, insulin, ghrelin and PYY levels compared to those elicited~     by Cream of Rice cereal. In addition, the relationship between amount, MW and viscosity of~     OBG and the primary and secondary objectives will be determined.~   "
5809|NCT03490838|"~     This Phase 1/2 study is intended to investigate the safety, tolerability, and radiation~     dosimetry of 177Lu-PSMA-R2 and further assess preliminary efficacy data in patients with~     metastatic castration-resistant prostate cancer (mCRPC). The Phase 1 portion of the study~     will determine the recommended dose of 177Lu-PSMA-R2 for radio-ligand therapy (RLT) of mCRPC,~     and the Phase 2 portion will expand into approximately 60 patients documenting the~     preliminary activity (anti-tumor response) of repeated treatments administered, continuing~     safety assessments and collecting QoL data.~   "
5810|NCT03490825|"~     This study aims to enhance circadian signals to improve cardiometabolic functions in older~     adults though meal timing interventions and melatonin supplements. Cardiometabolic disease~     (CMD) is prevalent among older adults, but despite vigorous research to prevent it, it~     remains on of the greatest public health challenges. Previous research has shown that~     extended overnight fasting and melatonin supplements may enhance circadian signals which in~     turn would enhance cardiometabolic function in older adults.~      This study will place subjects in one of four intervention groups, 1) Meal timing +~     Melatonin, 2) Meal timing + Placebo, 3) Melatonin, or 4) Placebo in order test out the~     effects of meal timing and melatonin both separately and together and cardio metabolic~     functions. The study will explore the effects of these interventions in acute-based (1-week)~     setting and extended-based (5 week) settings. This will allow us to test out the hypotheses~     of the study that meal timing can improve amplitude of circadian signals and improve~     cardiometabolic functions and sleep quality as well as melatonin improving cardiometabolic~     function and sleep quality. Finally, we will determine if the the addition of melatonin will~     further enhance the effects of the meal timing intervention for improving cardiometabolic~     function and sleep.~   "
5811|NCT03490812|"~     The goals of this study are to (1) develop and refine PET post-processing acquisition~     procedures, (2) generate preliminary and comparative imaging data for potential clinical~     trials, and (3) retrospectively evaluate standard of care PET imaging acquisitions by~     comparison with investigational PET imaging acquisitions.~   "
5812|NCT03490799|"~     clinical examination alone is usually insufficient in assessment of knee meniscus and a more~     reliable diagnosis can be achieved by using the knee ultrasound , magnetic resonance imaging.~      magnetic resonance imaging is considered the most noninvasive diagnostic method of detecting~     lesions of the intra-articular reliable knee structures. However, there are recent reports~     concluding that ultrasound is a valid technique for diagnosing meniscal lesions, even though~     it is not part of the standard protocol for evaluating injuries to the intra-articular knee~     structures.~   "
5813|NCT03490786|"~     Dose escalation study of GT-001~   "
5814|NCT03490773|"~     Type I diabetes(T1D)T occurs when an individual loses the ability to make enough insulin to~     control their blood sugar levels. They need insulin injections to replace the insulin~     production that has been lost. Traditionally people with T1D are thought to make none of~     their own insulin after diagnosis, but we have recently identified that there are some people~     who have T1D but go one making insulin for many years. We would like to explore this in more~     depth and understand why some people with T1D go on making insulin and some do not. This will~     help us understand the causes of T1D and may help work out ways to protect this remaining~     insulin production, with improved blood sugar control, and reduced long-term complications of~     diabetes We aim to explore genetic and immunological factors which impact on the ability of~     an individual diagnosed with Type I diabetes (T1D) to produce their own insulin. We aim to~     study individuals who have been diagnosed with T1D with variable duration and assess the~     genetic and immunological profile of those whose are thought to be producing significant~     amounts of insulin despite a long duration and those who despite a very short duration, lose~     insulin production very quickly.~   "
5815|NCT03490760|"~     This is a single-institution, single-arm phase II trial of durvalumab combined with Radiation~     Therapy (RT) for metastatic pancreatic cancer patients who have progressed through first-line~     chemotherapy.~   "
5903|NCT03489616|"~     The purpose of this study is to determine whether chemotherapy combination with local~     radiotherapy and rhGM-CSF is safe, effective in the treatment of oligometastatic stage IV~     NSCLC patients.~   "
5821|NCT03490682|"~     Current recommendations permit the ingestion of all clear fluids (water, apple juice, black~     coffee..) during labour. However, regarding food during labour, the recommendations vary.~     British and European guidelines permit the ingestion of low-residue food during labour whilst~     guidelines from the United States prohibit having any solid food during labour. The reason~     for this variation in recommendations is the lack of data on gastric emptying during labour~     with a conservative approach adopted due to the fear of delayed gastric emptying increasing~     the risk of regurgitation and pulmonary aspiration in the case of general anaesthesia. This~     study aims, therefore, to evaluate if the gastric emptying of a light meal is slowed down~     during labour, using a validated, non-invasive ultrasound method, in three groups of women :~     Women in labour (Parturient group), women in the third trimester of pregnancy (Pregnant~     group) and women who are not currently pregnant (Non-pregnant control group). The~     investigator propose the hypothesis that the gastric emptying of a light, solid meal is~     slowed by 30% during labour.~   "
5822|NCT03490669|"~     This is a 2-part study to evaluate the safety and antitumor activity of MSC-1. MSC-1 is a~     first-in-class, humanized monoclonal antibody (IgG1) which binds to the immunosuppressive~     human cytokine Leukemia Inhibitory Factor (LIF), and is intended to treat adult patients with~     Advanced Solid Tumors.~      In part 1, multiple dose levels of MSC-1 in patients with Advanced Solid Tumors will be~     studied to determine the recommended dose for further evaluation of safety and efficacy in~     Part 2.~   "
5823|NCT03490656|"~     The goals of this study are to (1) develop and optimize MRI acquisition and post-processing~     techniques and (2) to generate preliminary and comparative data on sequences for potential~     clinical trials.~   "
5824|NCT03490643|"~     The aim of the study is, to evaluate the whole body posture and plantar pressure~     distributions in individuals with Temporomandibular Disorder and also in people with healthy~     temporomandibular joints. A study group aged between 18-35 years, 30 patients, who were~     diagnosed with Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) who~     applied us with jaw pain and 30 healthy people at the same age range as a control group were~     included in the study. Both groups received global postural assessments by using~     PostureScreen Mobile® (PSM) program which is using four side photographs and the New York~     Posture Scale (NYPS). Static pedobarographic measurements were taken.~   "
5825|NCT03490630|"~     Prospective association study to analyse patients' outcome after bariatric surgery.~      Outcome comprises postoperative pain, analgesia, postoperative side-effects, long-lasting~     pain, patients' impairment in daily living.~   "
5826|NCT03490617|"~     The use of misoprostol at a dose of 400 µg administered vaginally four hours prior to IUD~     insertion increased the ease of insertion and reduced the incidence of pain during the~     procedure, although the frequency of cramps increased following misoprostol use.~   "
5827|NCT03490604|"~     Pancreatic cancer is the 5th leading cause of death from cancer in France. When chemotherapy~     can be proposed, the choice of treatment is currently based on the patient's profile and~     expected tolerance. The endpoints currently used in trials, such as time to therapeutic~     failure, do not take into account the patient's experience of the disease. The use of quality~     of life questionnaires is often proposed, but frequent missing data and filling time can be a~     problem. In oncology, some studies have demonstrated, through questionnaires, the link~     between physical activity and quality of life. In this situation, ambulatory measurement of~     physical activity by wrist actimetry could be an integrative reflection of the impact of the~     disease and treatment (efficacy, tolerance) on patients. This type of evaluation, if accepted~     by patients, could usefully complement the measurement of quality of life in this population.~     To our knowledge, no study has specifically looked at the use of devices of this type in the~     context of digestive cancer. We therefore propose to evaluate the acceptance of this type of~     device by pancreatic cancer patients receiving chemotherapy before evaluating its potential~     interest.~   "
5828|NCT03490591|"~     Objective: To investigate the effects of robot-assisted hand rehabilitation with a Gloreha~     device on hand function and the participation of ADL for children with cerebral palsy(CP).~      Materials and Methods: Five children with CP aged 6 to 18 years were recruited and received~     12times of robot-assisted hand rehabilitation for 6 weeks of treatment (Sixty minutes a time,~     twice a week). The performance was assessed by a assessor for three times (pre-test,~     post-test, follow up at one month). The outcome measures Fugl-Meyer Assessment-Upper Limb~     section(FMA-UE),Box and block test(BBT), Maximal voluntary contraction(MVC) of extensor~     digitorum communis(EDC), Flexor digitorum(FD), Grasp strength, & ABILHAND-Kids for ADL~     ability. Collected data will be analyzed with ANOVA test by SPSS version 20.0, and alpha~     level was set at .05. Our hypothesis are robot-assisted hand rehabilitation with a Gloreha~     device has positive effects on hand function and the participation of ADL for children with~     CP.~   "
5829|NCT03490578|"~     Robot-assisted gait training can improve gait ability of patients with Parkinson's disease by~     repeating a normal gait pattern with high intensity. This study is a randomized controlled~     trial to investigate the effect of robot-assisted gait training on walking ability and~     functional connectivity of brain in patients with Parkinson's disease using an exo-skeletal~     robot.~   "
5830|NCT03490565|"~     Background Patients undergoing resection for gastro-esophageal (GE)-cancer are subjected to~     high burden of disease and treatment-specific morbidities with potential detrimental impact~     on survival and quality of life. Exercise training is a promising strategy to improve~     physical functional before and after tumor resection, but it is not established if this~     translates into lower risk of peri- and post-operative complications, improved treatment~     tolerance.~      Objectives:~        -  To explore the effect a preoperative exercise-training intervention on the risk of~          treatment failure, defined as the risk of not reaching surgery, in patients diagnosed~          with operable GE cancer.~        -  To explore the effect of preoperative exercise training on median time to tumor~          progression (disease free survival), and overall survival~        -  To explore the effect of preoperative exercise training on the risk of treatment~          complications~        -  To explore the effect of preoperative exercise training on health related quality of~          life, anxiety and depression,cardiopulmonary fitness, muscle strength, and body~          composition~      Subjects and Methods In total, 310 GE-cancer patients will be included in the study and~     randomly allocated to pre-operative exercise training (n=155) or usual care control (n=155).~     All participants will undergo 2 study visits; assessed for cardiopulmonary fitness; muscle~     strength, body composition; blood sample (50 ml); quality of life by questionnaires; physical~     function; and blood volume profile.~      Quality of life will be assessed by questionnaires by self-report three times (at 12, 24, and~     36 months after diagnosis), and we will collect data from medical records regarding mortality~     and disease recurrence up to 36 months after diagnosis.~      Treatment arms:~      The intervention-group will be prescribed 2-3 weekly supervised exercise training for a total~     of 12 weeks before surgery during neo-adjuvant chemotherapy. The control group will follow~     current usual care guidelines. After surgery during adjuvant chemotherapy, both groups will~     be referred to municipality-based rehabilitation.~   "
25612|NCT03231696|"~     We assessed the visibility of peripheral nerves while ultrasound guided blockades with a~     novel scoring system to evaluate differences in visibility of different nerves.~   "
5832|NCT03490539|"~     This study is designed to address the evidence gaps in a real-world setting and help patients~     with MG choose treatments that are best suited to them. It is a prospective, multicenter~     observational cohort study of comparative effectiveness of MG treatments, with a~     patient-centered primary outcome measure, to guide clinicians, patients and payers regarding~     the choice of treatment options for this chronic and serious disease.~      Primary: To compare the effectiveness of azathioprine (AZT) and mycophenolate mofetil (MMF).~      Secondary: To compare the outcomes in patients receiving an adequate dose and duration of AZT~     or MMF over the 2 year study period, vs. patients not receiving adequate doses and duration~     of these agents~   "
5833|NCT03490526|"~     Caries disease is still the leading cause of severe tooth decay. Since this can lead to tooth~     loss, it is important that appropriate treatment is advised to help prevent damage and~     maintain tooth health. Faced with major coronary destruction, several times it becomes~     necessary to perform the endodontic treatment, aiming to maintain the element in the buccal~     cavity for longer. It is known that an excellent restorative treatment with poor endodontic~     treatment and vice versa has a direct impact on the (in) success of the treatment. In this~     context, the proper cleaning of the root canals is highlighted, aiming the removal of~     bacteria and toxins. There are several cleaning methods described in the literature, but it~     is not yet known which would be the most effective in the removal of these contaminants. In~     this double-blind randomized clinical trial, patients who need and meet the inclusion~     criteria will undergo endodontic treatment in two different root canal cleansing techniques~     (passive ultrasonic cleaning and cleaning with the XP Endo device). Patients will be~     monitored annually after finish your endodontic treatment to evaluate the periradicular~     repair and the quality of endodontic treatment.~   "
5834|NCT03490513|"~     The investigators have preliminary data suggesting that obese patients with hypogonadotropic~     hypogonadism (HHG) have minimal benefit from testosterone therapy likely because of its~     conversion to estradiol by the abundant aromatase enzyme in the adipocytes. The increased~     conversion of androgens into estrogens in obese men results in a negative feedback of high~     estradiol levels on hypothalamus and pituitary, inhibiting the production of~     gonadotropin-releasing hormone (GnRH), luteinizing hormone (LH) and follicle stimulating~     hormone (FSH) and, as a consequence, of testosterone by the testis. Testosterone~     administration could increase estradiol production, further promoting the inhibitory feedback~     to the hypothalamic-pituitary-gonadal axis. Although weight loss from lifestyle modification~     has been shown to reduce estradiol and increase testosterone levels, the effect is at best~     modest and weight regain results in recurrence of hypogonadism. The use of aromatase~     inhibitors, in combination with weight loss, could be an effective alternative strategy due~     to its action at the pathophysiology of the disease.~      Intervention Subjects (body mass index of ≥35, testosterone <300 ng/dl) will be randomized to~     the active (anastrozole) or control (placebo) group. Anastrozole 1 mg tablet / day will be~     self-administered with or without food, at around the same time every day (active group);~     placebo 1 tablet/day with or without food to take at around the same time every day (control~     group). The study duration will be 12 months.~      Both groups will undergo lifestyle intervention consisting of diet and supervised exercise~     program. Target weight loss will be at least 10% of baseline body weight during the~     intervention. Subjects will attend weekly group behavior modification sessions which will~     last ~75-90 min for the first 3 months and decreased to every two weeks from 3 to 12 months.~     Subjects will attend supervised research center-based exercise sessions during the first 6~     months followed by community fitness center-based sessions during the next 6 months for at~     least 2 d/wk, with recording of home-based exercises for the other 2-4 days/week.~   "
5835|NCT03490500|"~     The purpose of this study is to determine the negative predictive value of protein S100B that~     could exclude subarachnoid and intracranial haemorrhage for patient that present severe~     headache within the last 3 hours.~   "
5836|NCT03490487|"~     Benign epilepsy with centro-temporal spikes is the most common type of focal epilepsy in~     children. It is known to be age-dependent and presumably genetic. Age of onset ranges from~     one to fourteen years and it represents fifteen percent to twenty five percent of epilepsy in~     children under 15 years of age.~   "
5837|NCT03490474|"~     One in ten adults experience widespread pain. Neck pain, for example, is a prevalent~     condition with a high rate of recurrence that affects between 10.4% and 21.3% of the~     population annually.~      Massage is a common manual therapy intervention for individuals with musculoskeletal pain.~     However, the mechanisms of massage are not well established. Also, the conditioned pain~     modulation (CPM) paradigm is a dynamic quantitative sensory testing measure of a pain~     inhibitory process in which pain sensitivity is lessened in response to a remotely applied~     painful stimulus.~      This study will evaluate the association between pain inducing massage and the conditioned~     pain modulation paradigm.~   "
5838|NCT03490461|"~     This study aims to investigate whether statin therapy can help prevent recurrence of~     hepatocellular carcinoma (HCC) in transplant recipients who had liver transplantation for~     HCC. Multiple logistic regression analysis will be performed to evaluate the association~     between statin therapy and the risk of HCC recurrence after LT.~   "
5839|NCT03490448|"~     Vitamin D plays a significant role in calcium and phosphorus homeostasis for maintaining~     structural integrity and function of musculoskeletal system. Furthermore, recent studies have~     revealed that vitamin D can decrease the risk of many conditions other than skeletal disease,~     including autoimmune diseases, cancers, obesity and obesity-related diseases, such as type 2~     diabetes and cardiovascular disease. Vitamin D may influence calcium absorption to affect~     obesity indirectly, regulate adipocyte differentiation and relieve the development of~     metabolic syndrome by mediating levels of inflammatory factors.~      Another indicator of bone metabolism—osteocalcin may also be involved in energy metabolism~     and glucose metabolism, and undercarboxylated osteocalcin (ucOC) is the form which has~     physiological activity. ucOC may recombine with the receptors on the surface of pancreas β~     cells, adipocytes, hepatocytes and intestinal endocrine cell to regulate insulin secretion~     and insulin sensitivity.~      Currently, the prevalence of vitamin D deficiency is a global problem in all age groups~     currently, even in countries with sun exposure all year around. The obesity group tend to~     have a higher incidence of vitamin D deficiency.Moreover, the obesity group tend to have a~     higher incidence of vitamin D deficiency and a lower level of serum osteocalcin.~      This study observed the changes of body composition and glucolipid metabolism and bone~     metabolism during weight loss, and investigated the correlations among them.~   "
5840|NCT03490435|"~     The goal of the proposed study is to assess the prevalence of intestinal parasitic diseases~     in adults and children. These invasions are included to dirty hand diseases (per os~     invasions), therefore it applies mainly preschool children.~   "
5841|NCT03490422|"~     This Trial evaluated the extent of pulp survival following pulpotomy in the permanent tooth~     pulp exposed by caries and identify potential risk factors for pulpal complications.~   "
5915|NCT03489460|"~     A pilot study that seeks to develop a set of typologies of users of mobile sleep tracking~     technologies, and optimal sleep health educational strategies among users of mobile wearable~     technologies that track sleep.~   "
5842|NCT03490409|"~     The number of severely obese patients who has knee replacement surgery is rising. Obesity~     increases the risk of the postoperative swelling. A complication which can cause pain and~     discomfort as well as complicate and prolong rehabilitation.~      The aim of the present pilot study is to examine the effect of a compression stocking on~     postoperative swelling and pain among patients with a BMI ≥30 kg/m2, after total knee~     arthroplasty. The hypothesis is that the use of a medical elastic compression stocking for 14~     days postoperatively may reduce postoperative swelling by two cm.~      The pilot study will furthermore provide useful information for feasibility which will be~     used to decide whether or not a larger study should be initiated.~   "
5843|NCT03490396|"~     Patients receiving high-dose chemotherapy/conditioning prior to stem cell transplantation~     (SCT) are at high risk for developing painful lesions in the oral cavity, known as oral~     mucositis (OM).~      In this high risk adult population, the study objectives are to investigate the efficacy and~     tolerability of Gelclair® (GEL; an FDA cleared medical device indicated for the management of~     painful oral lesions) and ideal timing of initiation of therapy (at the time of conditioning~     or after mild OM is diagnosed) for the management of oral mucositis (OM), relative to a~     commercially available compounded mouth wash (First® Mouthwash BLM Magic Mouth Wash; MMW)~     initiated after mild OM is diagnosed. The study may be adapted based on an interim analysis~     and recommendations of the interim data review committee.~   "
5844|NCT03490383|"~     In this study, investigators will investigate the microbiota of bile in common bile duct~     stone participants. Three key questions are of concern. The first one is whether there is~     bacteriria in bile in participants without common bile duct stone. The second one is whether~     the microbiota of bile is similar with that of gut mucosa in common bile duct stone~     participants. The third one is whether the bacteria in bile of common bile participants with~     intact papillar is the same as that of participants underwent sphinctomy.~   "
5845|NCT03490370|"~     Non-alcoholic steato-hepatitis (NASH) affects up to 3% of the population and leads to liver~     cirrhosis, hepatocellular carcinoma (HCC) and death. The only known treatment is weight loss~     and exercise. Many patients cannot or will not achieve this with conventional means. The~     pathogenic process of the disease is insulin resistance which can be reversed relatively~     quickly with intense exercise or electrical stimulation of muscle. Most patients cannot~     achieve or sustain the level of aerobic exercise required; resistance exercise is more~     sustainable and similarly effective. The aim of this pilot study is to investigate whether~     electro-muscle stimulation, designed to emulate resistance exercise, resolves NASH in~     patients and moves them to a less dangerous metabolic steady state which should be easier to~     maintain.~   "
5846|NCT03490357|"~     The Transversus Abdominis Plane (TAP) block is the current standard of care for patients~     undergoing laparoscopic abdominal surgeries with the Enhanced Recovery After Surgery (ERAS)~     Protocol. The Quadratus Lumborum (QL) is another established abdominal fascial plane block~     that is comparable in procedure and risks and may potentially be more beneficial. The study~     compares the two blocks in hopes of establishing a new standard of care for patients~     undergoing laparoscopic abdominal surgeries with the ERAS protocol.~   "
5847|NCT03490344|"~     The purpose of this study is to test the safety of short course Daratumumab in combination~     with lenalidomide and to find out what effects, if any, short course Daratumumab in~     combination with lenalidomide has on people and their risk of multiple myeloma. The study is~     also designed to test the amount of remaining myeloma cells in your body after treatment with~     daratumumab which is known as minimal residual disease (MRD).~   "
5848|NCT03490331|"~     Prospective open-label, uncontrolled clinical study to assess the safety and efficacy of~     autologous cultured epidermal grafts containing epidermal stem cells genetically modified~     with the aid of a gamma-retroviral vector carrying COL17A1 complementary DNA (cDNA) for~     restoration of the epidermis in patients with junctional epidermolysis bullosa. The purpose~     of this study is to demonstrate the safety and efficacy after one or more treatments with~     genetically corrected cultured epidermal autograft (Hologene 17) in patients suffering of~     junctional epidermolysis bullosa (JEB) with COL17A1 mutation.~   "
5849|NCT03490318|"~     Given the high number of people with DMO and PDR, the need for patients to be seen at short~     follow-up intervals, the need for frequent treatments and the requirement for long-term~     follow-up, there is a very large workload in Hospital Eye Services related to DMO/PDR which~     is making it difficult for the NHS to cope with the demand, in particular, due to shortage of~     ophthalmologists. This is only expected to get worse given the increasing prevalence of DM.~     Identifying new ways of increasing the NHS capacity and efficiency without compromising the~     quality of care would greatly benefit the NHS.~      The purpose of this study is to determine whether successfully treated patients with DMO and~     PDR could be followed up without a face-to-face examination by an ophthalmologist. EMERALD~     will evaluate a new care pathway which will include multimodal retinal imaging and separate~     image assessment by trained ophthalmic graders. This new pathway will be compared to the~     current standard care pathway: for DMO: ophthalmologist evaluating patients in clinic by~     slit-lamp biomicroscopy and with access to OCT images; for PDR ophthalmologists evaluating~     patients in clinic by slit-lamp biomicroscopy. EMERALD will compare how accurate the new~     pathway is at determining which patients have active or inactive disease. The costs and~     acceptability of current and new models of care will also be compared.~   "
5850|NCT03490305|"~     The battle of Mosul was characterized by the use of improvised explosive devices, human~     shields and suicide bombers in an urban setting. It is unclear whether this type of warfare~     cause more extensive abdominal injuries to civilians than combatants. All patients admitted~     with penetrating abdominal injury subjected to an exploratory laparotomy at Emergency~     Hospital, Erbil, between October 17, 2016 and July 16, 2017 will be included. Differences in~     demographics, injury mechanism, time since injury, clinical status on arrival, intraoperative~     findings, postoperative complications and outcome will be studied.~   "
5851|NCT03490292|"~     This is a 2 part Phase I/II clinical trial evaluating the safety, tolerability and efficacy~     of avelumab in combination with chemoradiation in patients with resectable esophageal cancer.~      Part 1: This is the run-in phase of the trial. This portion will determine the safety and~     tolerability of avelumab in combination with chemoradiotherapy in 6 patients. The proposed~     combination will be considered as safe if dose limiting toxicities are observed in at most 1~     patient.~      Part 2: This is a Phase 2 portion of the trial, which will evaluate the efficacy of the~     proposed treatment regimen in patients with stage II/III resectable esophageal cancer~   "
5852|NCT03490279|"~     Diverticular disease is a chronic pathology, characterized by recurrent abdominal symptoms~     and a high social impact, with a high prevalence in developed countries, especially among the~     elderly. Diverticula are thought to develop from age-related degeneration of the mucosal wall~     and segmental increases in colon pressure resulting in bulging at points of weakness,~     typically at the insertion of the vasa recta. Classification of diverticular disease is~     largely based on symptoms: it begins with the development of diverticulosis, to asymptomatic~     disease, to symptomatic uncomplicated diverticular disease (SUDD) and finally to complicated~     disease when patients develop abscesses, phlegmon, bleeding, fistula and sepsis.~     Approximately the 20% of the patients with diverticular disease has symptoms, such as~     abdominal pain, fever and altered bowel movement and, in the last decades, a significant~     increase of the incidence of complications related to the disease has been recorded, in~     particular of intestinal perforation.~      Lactoferrin (Lf) is a glycoprotein present in several secretory liquids - i.e. milk, saliva~     and tears - with antimicrobial properties that it exert to seizing iron, thus preventing the~     use by the pathogens, or altering their plasma membrane through its highly cationic charge.~      The investigators hypothesize that the antimicrobial and immunoregulatory characteristics of~     the Lf can be used to maintain an adequate homeostasis of the intestinal mucosa in patients~     with SUDD resulting in an improvement of both symptoms and quality of life.~   "
5853|NCT03490266|"~     Ventral hernias are a common disease and one half of all individuals are born with or will~     acquire a ventral hernia in their lifetime. Repair of ventral hernias may be associated with~     significant morbidity, including surgical site infection, hernia recurrence and reoperation.~     Minimally invasive ventral hernia repair decreases rates of surgical site infection and~     hospital length of stay, without affecting recurrence, however the laparoscopic approach to~     ventral hernia repair accounts for only about 1/3 of all total hernia repairs performed in~     the US. Recent large database studies have suggested that robotic ventral hernia repair may~     be associated with decreased hospital length of stay. However, this study is affected by~     common biases of database studies and randomized controlled trials are needed to assess the~     true impact of robotics for ventral hernia repair.~   "
5854|NCT03490253|"~     The first goal of the randomized trial will be to study the influence of personalized text~     messaging on both glycemic control and depressive symptoms. The primary outcomes for this aim~     will be improvements in physical activity. The secondary outcomes include diabetes and~     depressive symptoms at the 6-month follow-up, as well as mood and quality of life.~      The secondary goal of the trial is to evaluate the influence of nurse phone outreach on~     glycemic control and depressive symptoms for participants who are non-responsive to the text~     messaging approaches used in this study. In particular, a sequential multiple assignment~     randomized trial (SMART) design will use responsiveness data from participants during the~     course of the study to implement a second randomization step for nurse phone outreach.We will~     examine the same primary outcome and secondary health behavior outcomes among this sub-group.~   "
5855|NCT03490240|"~     This randomized controlled trial will examine the effect of a 6-month behavioral~     intervention, based on social cognitive theory and delivered through the Internet, for~     increasing physical activity and secondarily improving mobility, cognition, symptoms and~     quality of life in persons with MS. The investigators hypothesize that individuals who~     receive the 6-month behavioral intervention will demonstrate an increase in physical activity~     behavior that will last throughout a 6-month follow up compared with participants in the~     control condition. The investigators further hypothesize that individuals in the behavioral~     intervention will demonstrate better walking mobility and cognitive function, reduced~     fatigue, depression, anxiety, and pain, and improved quality of life compared to the control~     condition. The investigators hypothesize that the behavioral intervention will increase~     physical activity through positive changes in self-efficacy, outcome expectations, goal~     setting, and impediments as social-cognitive determinants.~   "
5856|NCT03490227|"~     Up to 10 infants will complete the study aimed to establish a technique for measuring whole~     body adiposity and brown adipose tissue in infant subjects using dual energy x-ray~     absorptiometry and magnetic resonance imaging, respectively.~   "
5857|NCT03490214|"~     This pilot study aims to assess subcellular muscle structure in patients with Duchenne~     X-linked progressive Duchenne muscular dystrophy (DMD) in comparison to healthy volunteers~     using multispectral optoacoustic tomography (MSOT). During MSOT, a transducer is placed on~     the skin similar to a conventional sonography and instead of sound, energy is supplied to the~     tissue by means of light flashes. This leads to a constant change of minimal expansions and~     contractions (thermoelastic expansion) of individual tissue constituents or molecules. The~     resulting sound waves can then be detected by the same examination unit.~   "
5858|NCT03490201|"~     This clinical investigation is intended to demonstrate the safety and effectiveness of~     ventricular ablation therapy using the FlexAbility Sensor Enabled Ablation Catheter in~     patients with drug-refractory monomorphic ventricular tachycardia in whom ventricular~     tachycardia recurs despite antiarrhythmic drug therapy or when antiarrhythmic drugs are not~     tolerated or desired.~   "
5859|NCT03490188|"~     There is an increasing number in patient's undergoing kidney transplantation in the United~     States. Furthermore, kidney recipients have high occurrence of 30-day readmissions that leads~     to high hospital costs and decreased quality of life for transplant recipients. A previous~     research finds that high levels of post-transplant anxiety is correlated with increased~     likelihood of 30-day readmissions. The goal of this study is to design and implementat a~     randomized control trial (RCT) using a standardized post-transplant mentoring program in~     order to reduce 30-day readmission and post-transplant anxiety among recipients.~   "
5860|NCT03490175|"~     Prospective observational study to analyse the association of non-genetic variables as well~     as genetic variants of candidate genes with the incidence of postoperative nausea and~     vomiting (PONV).~   "
5916|NCT03489447|"~     A study of short and long term mortality in patients treated with or without a diagnosis of~     sepsis in Swedish intensive care units (ICU) 2008 - 2016. The cohort is characterized with~     regard to chronic comorbidity, severity of acute illness and demographic factors, and outcome~     is adjusted for these factors. Changes in mortality during the period are studied.~   "
8784|NCT03451903|"~     This study aims to identify factors influencing the time span and success of reperfusion~     after a mechanical thrombectomy in the acute phase of cerebral infarction, and in particular~     the effect of intra-venous thrombolysis.~   "
5861|NCT03490162|"~     This is a phase 1 trial to evaluate the safety and pharmacokinetics of single and multiple~     ascending doses and effect of food on the pharmacokinetics of a novel antimalarial drug in~     healthy adults. The study will enroll 96 healthy volunteers, males and females, aged 18 to 45~     years and will consists of 3 parts: Part 1, Single Ascending Dose (SAD); Part 2, Multiple~     Ascending Dose (MAD); and Part 3, Food Effect. Part 2 and Part 3 may be initiated after a~     Safety Monitoring Committee (SMC) review and approval of the of Part 1 safety data. Study~     duration will be 13 months with patient participation duration 14 days for SAD and Food~     Effect, and 18 days for MAD. The primary objectives of this study are to: 1) assess the~     safety and tolerability of single doses of DM1157 at levels ranging from 9 mg to 900 mg; 2)~     assess the safety and tolerability of DM1157 administered as single daily doses for 3 days at~     levels ranging from 150 mg to 900 mg; 3) assess the safety and tolerability of DM1157~     administered with or without food.~   "
5862|NCT03490149|"~     The study aims to use machine learning to predict the occurrence of episodic and~     autobiographical memory deficits as well as treatment response following a course of~     electroconvulsive therapy. Additionally, the neurophysiological correlates of the cognitive~     effects after a course of ECT will be investigated.~      Therefore, structural, resting-state and diffusion tensor images will be collected within one~     week before the first and after the last ECT treatment from severely depressed patients.~     Standard measures of cognitive function and specifically episodic as well as autobiographical~     memory will also be collected longitudinally and used for prediction. The study consists of~     60 ECT receiving inpatients suffering from major unipolar or bipolar depression, 60~     medication-only controls and 60 healthy controls.~   "
5863|NCT03490136|"~     Series of epidemiological studies have been carried out by the research team since 1988~     studying the changes in the prevalence of type 2 diabetes, prediabetes and associated risk~     factors. These studies have shown that the determinants to rising prevalence of diabetes vary~     among populations and with time. Comparative studies from the same region can help to~     understand the secular changes occurring in a specific population. In this proposal we intend~     to conduct a cross-sectional survey with varied levels of urbanisation and compare the~     findings with our earlier reported data to assess the degree of changes in dysglycaemic~     prevalences. The primary aim of the proposal is to study the secular changes and the~     prevalence of diabetes, prediabetes and associated cardio-metabolic risk factors with varying~     levels of urbanization.~      A multi-stage random selection method will be used. Field workers will conduct an enumeration~     of the individuals above 20 years of age. In each location, streets will be randomly selected~     to have an equal representativeness from different socio-economic strata. All eligible family~     members of the selected households are invited for the survey. The study outcomes will be of~     relevance in public health research in modeling effective national healthcare policies.~   "
5864|NCT03490123|"~     The current principle of yaws eradication (the Morges strategy) is based on single round mass~     drug administration (MDA) of azithromycin (AZI) called total community treatment (TCT)~     followed by targeted treatment of active cases every 6 months to detect and treat cases and~     contacts called total targeted treatment (TTT). Studies done in Papua New Guinea (PNG) show~     that 1 round of MDA will probably not suffice to stop transmission of infection. It may be~     preferable to conduct 3 rounds of MDA prior to the switch to TTT because of high coverage~     requirements to achieve elimination, particularly of latent cases. The investigators plan to~     determine whether 3 rounds of MDA are more effective for reaching yaws elimination. This~     research is needed to guide national programmatic implementation and needs to be done as soon~     as possible to scale up the program in the country.~      The aim of this proposal is to ascertain the number of rounds of MDA with AZI to be included~     in an improved strategy towards yaws eradication. The study will be implemented in 43 wards~     of New Ireland Province (NIP). The investigators will compare two different distribution~     strategies of MDA: (A) strategy with 3 biannual rounds of MDA and (B) a single mass treatment~     round of MDA followed by targeted treatment of cases and contacts. The investigators will~     also monitor the risk of appearance of antimicrobial resistance in Treponema pertenue.~   "
5865|NCT03490110|"~     Some of the most common, persistent, and disabling consequences of traumatic brain injury~     affect an individual's ability to achieve personal goals. Interventions that strengthen~     abilities such as being able to concentrate, remember, stay calm and overcome challenges,~     could have far reaching benefits for Veterans. One challenge in rehabilitation is that~     response to training can be highly variable, and a better understanding of the neural bases~     for this variability could inform care. This project will test whether changes in markers of~     the brain's electrical activity (using the non-invasive technique of electroencephalograms,~     EEG) can explain differences in responses to skill training.~   "
5866|NCT03490097|"~     The purpose of the study is to determine if statin can affect the clinical outcome of chronic~     hepatitis C patients receiving Sofosbuvir/Daclatasvir/Ribavirin combination~   "
5867|NCT03490084|"~     The study aims to compare the overall survival adjusted to quality of life of 2 groups of~     patients with multiple myeloma, depending on the type of care: (1) day hospitalization~     exclusively or (2) day hospitalization combined with hospital-at-home.~      As secondary objectives, the study aims to compare the impacts of the two types of care~     organization on:~        -  the survival of patients and response to treatments according to criteria of the~          International Myeloma Working Group,~        -  psychological status of patients,~        -  specific toxicity related to treatment used (haematological and infectious toxicity,~          neurotoxicity, ...),~        -  health outcomes,~        -  the caregiver's burden,~      This study is combined with a qualitative study about the incentives and the barriers, and in~     order to set up the patient's typology.~   "
5868|NCT03490071|"~     In this longitudinal cohort study including young to middle aged people with longstanding hip~     and groin pain (LHGP) referred to tertiary care, we will collect data of patient reported~     symptoms, function and quality of life three and five years after the initial contact with~     orthopedic surgeon.~   "
5869|NCT03490058|"~     The POWER Cohort study is a PrEP implementation project to demonstrate Pre-exposure~     prophylaxis (PrEP) delivery for young women in Cape Town and Johannesburg, South Africa and~     Kisumu, Kenya.~   "
5956|NCT03488914|"~     This study will conduct an effectiveness trial of the 4-session evidence-based YMHP~     intervention for YMSM of color ages 15-29 at two CBOs in New York City, compared to usual~     care.~   "
5870|NCT03490045|"~     Well-child care is the primary source of preventative health care for children. These visits~     provide an opportunity for physicians to assess an infant's biomedical health, development,~     and behavior, as well as help ensure timely immunizations, reduce the use of acute care~     services, and assess and family functioning. Yet, disparities in the utilization of pediatric~     care exist by race, ethnicity and income in the U.S., even despite high rates of overall~     access to primary care. Incentives have been proposed as one way to increase utilization of~     preventative care for mothers and children.~      Diapering is another important form of preventative health care that can be particularly~     difficult for low-income parents due the cost of diapers, which is $70-80 per child per~     month, or approximately $960 per year, on average. And government programs, such as Special~     Supplemental Nutrition Program for Women, Infants, and Children (WIC), Supplemental Nutrition~     Assistance Program (SNAP), and Temporary Assistance for Needy Families (TANF), either cannot~     be used to purchase diapers, or do not provide enough assistance to cover the cost of diapers~     and other basic needs. A family's inability to provide an adequate supply of diapers for~     their child is called diaper need. Nationwide, one in three families with young children~     report experiencing diaper need, which was found to be significantly associated with maternal~     stress and depression, which in turn, can have a detrimental impact on a family's health and~     economic success.~      The primary goal of this study is to conduct a randomized controlled trial of a diaper~     provision intervention designed to increase utilization of, and adherence to, well-child~     visits and reduce diaper need among low-resourced families in New Haven, CT.~   "
5871|NCT03490032|"~     Assessment of the safety and tolerability of a single administration of 3 mega Becquerel~     (MBq)/kg, but not less than 150 MBq and not more than 250 MBq, of 68Ga-PSMA-R2, to assess the~     pharmacokinetics (PK), biodistribution, and dosimetry of 68Ga-PSMA-R2, and to establish the~     optimal imaging method for determining location and burden of positive lesions in adult male~     patients with biochemical relapse (BR) and metastatic prostate cancer (mPCa).~   "
5872|NCT03490019|"~     In this prospective pilot study without control group children and young adults (10-25 years~     old) diagnosed with Bardet-Biedl syndrome and treated with Metformin for their adipositas~     will be evaluated for a possible additional effect of Metformin on visual acuity.~   "
5873|NCT03490006|"~     In this randomized, controlled, observer-blinded study the investigators plan to evaluate~     ultrasound-guided thoracic paravertebral block (TPVB) and ultrasound-guided thoracic erector~     spinae plane (TESP) block for postoperative pain management after unilateral total mastectomy~     without immediate reconstruction.~   "
5874|NCT03489993|"~     Hereditary hypophosphatemia encompasses rare genetic conditions characterized by renal~     phosphate wasting. Increased circulating levels of fibroblast growth factor 23 (FGF23), a key~     regulator of phosphorus metabolism, are critical to the pathophysiology of these diseases,~     most notably in X-linked hypophosphatemia (XLH). Increased FGF23 induces hypertrophy and~     scarring in the heart in part via stimulating the traditional renin-angiotensin system (RAS)~     pathway, angiotensin-converting enzyme (ACE)/angiotensin (Ang ll), particularly in patients~     with chronic kidney disease, but the effect of FGF23 on the heart in patients with~     FGF23-related hypophosphatemic diseases is unknown. In addition, the relationship between~     FGF23 and the angiotensin-converting enzyme 2 (ACE2)/angiotensin-(1-7) (Ang-(1-7) pathway of~     the RAS is unknown.~      The objective of this study is to describe the relationship between FGF23, which causes low~     phosphorus levels, and components of the RAS in the blood and urine to help the investigators~     understand why the disease occurs and how to better treat it.~      Subjects will be identified by querying the Electronic Medical Record according to medical~     diagnosis. Thirty subjects, 2-24 years of age, will be recruited from the tertiary care~     Pediatric Endocrinology and Pediatric Nephrology clinics at Brenner Children's Hospital.~     Inclusion criteria include a confirmed diagnosis of hereditary FGF23-related~     hypophosphatemia. Clinical data will be obtained from the Electronic Medical Record. Each~     subject will undergo study assessments at baseline, 6 months and 1 year that include blood~     work, an echocardiogram, and blood pressure measurements.~      The primary hypothesis is that subjects with higher Ang-(1-7) levels have lower rates of~     cardiac hypertrophy and thus are protected against high FGF23 levels. The secondary~     hypothesis is that subjects with higher Ang-(1-7) levels have lower systolic blood pressure.~   "
5875|NCT03489980|"~     Evaluate the contribution of a coloring-type artistic task of a complex form in the reduction~     of anxiety related to care and pathology by a self-questionnaire State-Trait anxiety~     inventory and a self-questionnaire on the experience of the activity, in 3 different medical~     situations: in day hospitalization service in psychiatry, in hemodialysis service and in an~     ambulatory consultation waiting room.~   "
5876|NCT03489967|"~     According to guidelines, when a mild-to-moderate hypoglycemia occurs (capillary blood glucose~     < 4.0 mmol/L), 15-20g of rapidly absorbed carbohydrates should be ingested. Patients should~     re-test and re-ingest 15-20g carbohydrates every 15 minutes until they recover from~     hypoglycemia. These recommendations were principally based on two studies conducted in the~     80s before the introduction of intensive insulin therapy secondary to the DCCT trial and with~     insulin formulations with largely different pharmacokinetic profiles from current insulin~     analogs. Recent studies suggest that with current insulin analogs and intensive therapeutic~     approach, 15g of carbohydrates may be insufficient to rapidly correct an important proportion~     of hypoglycemic episodes. It is thus important to determine if the recommended hypoglycemia~     treatment remains the recommendation.~   "
5877|NCT03489954|"~     The aims of this research are to investigate relationship of deep cervical flexor muscle~     endurance with neck position sense and body balance in non-specific chronic neck pain, and to~     compare the results with healthy individuals.~   "
5878|NCT03489941|"~     A Single-Center study to demonstrate the non-inferiority of EM-100 to Zaditor® in the~     treatment of ocular itching.~   "
5879|NCT03489928|"~     Labour induction is a frequent obstetric intervention (~20%). Prostaglandins (PGs) are~     effective agents, but gastrointestinal (GI) intolerance has limited use to non-oral routes.~     The traditional oxytocin drip requires intravenous (IV) use and discourages mobility.~     Misoprostol, a PG analogue, is marketed for oral treatment of GI disorders, but initiates~     uterine contraction, an undesirable GI side effect. Recently, there has been a research~     boom on vaginal misoprostol use in pregnancy to induce term labour drawing on this side~     effect:. The principal investigator has led one of three groups worldwide which has~     published on oral misoprostol to study effectiveness, GI tolerance, and safety for~     mother/baby in term labour induction. Cost per patient has been less then one percent that of~     other PGs, even less than IV oxytocin.~   "
5880|NCT03489915|"~     Correlation between changes observed in OCT and VA in patients with retinal vein occlusion~     whether the patient's VA improves when macular edema improves in OCT or not ??~   "
5881|NCT03489902|"~     Clinical trial comparing the new technique for paravaginal repair versus the traditional~     technique~   "
8785|NCT03451890|"~     This study will be conducted to evaluate the safety, tolerability, and pharmacokinetics of~     single ascending oral doses of E2730 in healthy adult participants.~   "
5882|NCT03489889|"~     A manipulation and an integral part of the pharmaceutical practice, where, in addition to the~     supply of medicines and personalized products, they represent an alternative to the~     therapeutic schemes, manipulating drugs of almost all of them as therapeutic categories.~      One of the products and ursodeoxycholic acid, commercially known as Ursacol, a bile acid~     physiologically present in human bile, approved by Agência Nacional de Vigilância Sanitária~     (ANVISA), among several indications, for the treatment of the symptomatic form of primary~     biliary cholangitis, autoimmune etiology and predominant incidence in female.~      This is a prospective, cross-over, interventional and open-label study, where patients~     attending the inclusion and exclusion criteria are attended by the Instituto Central do~     Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (ICHC-FMUSP)~     Pharmacy Division in the Pharmaceutical Care sector.~      As patient information as well as the prescribed drugs, compiled by a data collection~     instrument from the ICHC-FMUSP Pharmacy Division and a semi-structured questionnaire.~   "
5883|NCT03489876|"~     This is a prospective, randomized, controlled clinical trial comparing synthetic cartilage~     implantation versus osteochondral autograft transfer for treatment of first~     metatarsophalangeal (MTP) arthritis. This data will allow for accurate comparisons between~     the two groups in regards to functional outcome, clinical outcome, pain relief, and~     complications.~   "
5884|NCT03489863|"~     Polymorphisms of the cytochrome P450 (CYP) 2C19 enzyme has been consistently shown to~     modulate clopidogrel response. Accordingly, the Food and Drug Administration (FDA) has issued~     a warning on the potential for reduced efficacy of clopidogrel among carriers of~     loss-of-function alleles (LOF) for CYP2C19 and suggest considering alternative antiplatelet~     therapies for these individuals.~      The pharmacodynamic (PD) effects of prasugrel and ticagrelor are not affected by CYP2C19~     genetic polymorphisms. However, to date there are no head-to-head PD comparisons between~     these agents among patients with different CYP2C19 genetic polymorphisms, which is currently~     under investigation in CAD patients undergoing PCI at UF Health-Jacksonville (UFJ 2014-12,~     NCT 02065479). In order to rule out play of chance findings, pharmacogenetic investigations~     require external validation cohorts to support the study findings. Therefore, the present~     randomized study is designed to serve as an external validation cohort conducted in patients~     with established CAD not undergoing PCI testing the non-inferiority in platelet reactivity of~     prasugrel versus ticagrelor among CYP2C19 LOF allele carriers.~   "
5885|NCT03489850|"~     Alcohol use disorder (AUD) is a prevalent and disabling psychiatric disorder with few, and~     only moderately efficacious, treatment options. Consequently, the identification of novel~     treatment targets and the development of rigorous laboratory paradigms to screen and optimize~     novel therapeutics represents a research priority. Ibudilast (IBUD) is a neuroimmune~     modulator that inhibits phosphodiesterase-4 and -10 and macrophage migration inhibitory~     factor. Recently in an AUD sample, IBUD was shown to decrease reactivity to a psychological~     stressor. Furthermore, IBUD was effective in blunting alcohol reward among participants with~     greater depressive symptoms, a hallmark symptom of protracted withdrawal. Recently,~     preclinical research in opiates has demonstrated that drug withdrawal is necessary for~     microglia activation and neuroinflammation in reward networks, suggesting that IBUD may be~     most effective among patients who experience withdrawal-related dysphoria. Therefore, this~     proposed study aims to examine withdrawal-related dysphoria as a moderator of IBUD efficacy~     in the natural environment measured using Daily Diary Assessment (DDA) approaches. To~     accomplish this aim, participants meeting criteria for AUD and balanced on the presence of~     withdrawal-related dysphoria will be enrolled in a double-blinded IBUD trial including~     consisting of two weeks randomized to medication and DDA assessment. The proposed research~     aims are:~      Aim 1: Test whether IBUD reduces basal negative affect in abstinence, and blunts~     alcohol-related negative reinforcement. It is hypothesized that IBUD will reduce basal levels~     of negative affect during alcohol abstinence, and in so doing will interfere with~     alcohol-induced blunting of negative affectivity as captured during naturalistic drinking~     episodes.~      Aim 2: Test whether IBUD attenuates neural alcohol cue-reactivity. It is hypothesized that~     IBUD will reduce BOLD activation to alcohol cues in mesocorticolimbic reward circuitry.~      Aim 3: Test whether withdrawal-related dysphoria moderates the effects of IBUD. It is~     hypothesized that IBUD will alleviate basal negative affect, interfere with alcohol-induced~     negative reinforcement and attenuate BOLD activation to alcohol cues only among participants~     who experience dysphoria in withdrawal.~      Aim 4: Test whether neural activation to alcohol cues is predictive of drinking outcomes. It~     is hypothesized that individuals with higher mesocorticolimbic activation to alcohol cues~     will report more drinking in the week following the neuroimaging session.~   "
5886|NCT03489837|"~     A randomized, double-blind, multicenter, active-controlled phase III study to evaluate the~     efficacy and safety of Levotuss CR tab. in comparison with Levotuss syrup in patients with~     cough due to acute or chronic bronchitis~   "
5887|NCT03489824|"~     Abdominal discomfort is of the most important patient interest when in an unsedated~     colonoscopy examination. Water method for colonoscopy examination has been studied widely and~     evidence showed effectiveness in reducing discomfort and increase cecal intubation time and~     increasing cecal intubation rates in unsedated patients.~   "
5888|NCT03489811|"~     This study evaluates the effects of essential oils on anxiety scores among children who have~     an autism spectrum disorder. One third of the children will receive a control blend of oils,~     one third of the children will receive a test blend of oils, and the other third will receive~     a second test blend of oils.~   "
5889|NCT03489798|"~     To compare two protocols of misoprostol use for cervical ripening: 3 doses (25 ug vaginal~     each) or up to six doses, every six hours, until an adequate cervical condititon was achieved~     (BIshop score > 6). In the first group, after 3 doses, the patient was sent to the delivery~     room for induction with oxytocin and in case of failure, a cesarean section was indicated for~     this reason. In the second group, up to six doses were used in a similar fashion. Rates of~     success were evaluated, as well as maternal and fetal complications.~   "
5890|NCT03489785|"~     The purpose of this study was to identify the predictive factors of unpredicted movement in~     motor evoked potential (MEP) during intraoperative neurophysiologic monitoring in adult~     patients undergoing brain surgery.~   "
5891|NCT03489772|"~     This is a single site, randomized, double-blind, placebo-controlled, within-subjects study~     design in healthy volunteers. Escalating single doses of ITI-214 will be evaluated using~     functional magnetic resonance imaging (fMRI) to determine central nervous system engagement.~     Safety and tolerability also will be assessed.~   "
5892|NCT03489759|"~     The study evaluate the effect of a membrane in polysulfone covered with vitamin E (ViE15-A,~     ASAHI Kasey, Tokyo, Japan) versus non-vitamin E polysulfone membrane (REXEED-15A, ASAHI~     Kasey, Tokyo, Japan) in critically ill patients admitted to intensive care undergoing~     continuous extracorporeal dialysis (CRRT).~      The current randomized study is designed to assess the effect on the levels of oxidative~     stress, pro and anti-inflammatory cytokines and the mode and amount of death of monocytic~     cell lines using ViE 15-A in comparison withe REXEED-15A.~      The investigators hypothezise that the ViE15-A versus REXEED-15A will have different effect~     on the levels of oxidative stress, pro and anti-inflammatory cytokines and the mode and~     amount of death of monocytic cell lines.~   "
5893|NCT03489746|"~     The SWIFT trial is a cluster randomised trial to determine if a patient identification,~     feedback and inhaled corticosteroid (ICS) withdrawal intervention in primary care can result~     in more appropriate inhaled corticosteroid use without increasing the frequency of~     exacerbations. Practices in Tayside and Fife will be randomised at practice level to an~     intervention or control. The intervention will consist of electronic review of patients~     Chronic obstructive pulmonary disease (COPD) data and prescribing history, followed by~     implementation of a medication change involving withdrawal of ICS and introduction of a Long~     acting beta adrenergic agonist (LABA) and Long acting muscarinic antagonist (LAMA) for~     patients without an indication for ongoing ICS treatment. Patients in control practices will~     not receive the intervention, but practices will be provided with local guidelines and~     formulary and encouraged to prescribe appropriately. Patients in the control practices may be~     switched to guideline compliant medications. Our hypothesis is that removal of non-evidence~     barriers to appropriate prescribing will result in in high rates of ICS withdrawal and that~     the intervention will be safe, as evidenced by no increase in the frequency of exacerbations~     over 12 months of follow-up.~   "
5894|NCT03489733|"~     A multi-center, prospective, randomized, controlled, doubleblind intervention clinical Trial~     is performed to proof the efficiency of hydrolyzed infant formula showing a risk reduction of~     developing an allergy.~   "
5895|NCT03489720|"~     This study seeks to evaluate the prevalence and characterize predictors of physician burnout~     in the anesthesia residency at Vanderbilt University Medical Center. The study also seeks to~     evaluate the effect of an exercise intervention on burnout and personal resiliency (i.e.,~     less individual stress given the same workload).~   "
5896|NCT03489707|"~     The purpose of this research study is to find ways to screen for anal cancer among gay,~     bisexual, and other men who have sex with men (MSM). This study will try to find out if~     persons will do annual anal cancer screening, what factors are associated with repeated~     screening, and how this effects a person's decision to have high-resolution anoscopy.~   "
5897|NCT03489694|"~     This study will examine the within-tester repeatability and between-tester reproducibility of~     skin test endpoint titrations performed in those with allergic sensitivities.~   "
5898|NCT03489681|"~     Sciatica is a common pain disorder in the neurological clinic that typically present as low~     back or gluteal pain and may radiate to one leg with motor or sensory complaint. Sciatica has~     drawn more attention worldwide as a public health issue for its pain disability, high~     prevalence and significant medical and economic burden. A meta-analysis of sciatica treatment~     revealed discectomy, epidural injections, non-opioid analgesics, and acupuncture might~     relieve pain. However, the central effect of acupuncture-induced analgesia and its functional~     connectivities in various brain region remain unclear. Besides, the number of acupoints~     selection and its correlation in functional connectivity also need to be discussed. This~     clinical trial would collect the sciatica subjects assign by intent to treat, divided to~     acupuncture and non-acupuncture herbal control group. The treatment of acupuncture assigns~     randomized as high dose and low dose acupuncture group. The acupuncture will perform two~     times a week for four weeks. The primary outcomes are visual analog scale for pain and~     sciatica bothersomeness index; the secondary outcomes are Roland's disability questionnaire~     for sciatica, WHOQOL, and traditional Chinese medical constitutional scale. The functional~     magnetic resonance imaging scan would apply at the baseline and after four weeks' treatment.~     This study aims to explore the model of DMN in sciatica patients; it's central effect in~     different stimulation modality and to investigate the mechanism of the long-lasting,~     sustained impact in different acupuncture dosage.~   "
5899|NCT03489668|"~     Rationale and Hypothesis We have previously reported that theca cells (TC) responses to hCG~     in women with PCOS represent a spectrum where some exhibit exaggerated increases of 17OHP~     while in others 17OHP responses resemble those of normal women (Maas KH et al, JCEM, 2015).~     The basis for this differential responsiveness is not clear. Earlier studies reported that~     17OHP responses to gonadotropin stimulation were heterogeneous among PCOS women, which was~     attributed to the degree of hyperinsulinemia (Pasquali R et al, JCEM, 2007). However,~     assessment of the ovary was omitted in the analysis. In preliminary studies, we have found~     that in women with PCOS, insulin sensitivity was strongly correlated with insulin sensitivity~     index as assessed by the method of Matsuda and DeFronzo (Diabetes Care, 1999). However, the~     study lacked sufficient numbers. Further analysis of insulin sensitivity with respect to hCG~     stimulated theca cell responses is warranted.~      We have also examined 17OHP responses to hCG in relationship to antral follicle count and~     anti-Müllerian hormone (AMH) in PCOS and normal women. In PCOS women, as expected, serum AMH~     correlated with antral follicle count. However, TC responses in PCOS were inversely related~     to AMH (Maas KH et al, JCEM, 2015). These novel observations suggested that in PCOS AMH~     production may reflect redistribution of the follicle population. In human ovaries maximal~     immunodetection of AMH is observed in small (< 4 mm) antral follicles followed by a rapid and~     progressive decline until an absence of the protein by 8 mm (Weenen C et al, Mol Hum Reprod,~     2004). This consideration raises the issue of whether normal AMH levels represent more~     advanced follicle growth in some PCOS women compared with that of others with elevated AMH~     levels. An increased stage of follicle development would be accompanied by increased TC~     hyperplasia and may account for greater 17OHP responses to hCG stimulation. A comparison of~     TC responses to hCG with ovarian morphology has not be done in women with PCOS.~      Based on these findings, we hypothesize that in PCOS, heterogeneous TC responses to hCG~     reflect differences in morphometric development of the follicle population. In addition, the~     positive correlation between insulin sensitivity and TC responses to hCG suggest an effect of~     hyperinsulinemia. We propose to investigate the relationship between theca cell responses to~     hCG, follicle morphology, and insulin sensitivity before and following treatment with an~     insulin lowering drug, metformin.~   "
5900|NCT03489655|"~     Adults with asthma living in Chicago's West and Southwest side who completed the home-based~     Community Health Worker (CHW) intervention called Helping Chicago's Westside Adults Breathe~     and Thrive (HCWABT I) after October 2015 were eligible to participate in a randomized control~     trial called HCWABT II, which will evaluate the long-term impact of the intervention on their~     asthma control, asthma severity, healthcare use, and asthma-related quality of life.~     Participants are randomly assigned to an intervention arm, where they continue to receive~     occasional (monthly or bimonthly) contact from the CHW who served them during HCWABT I. or a~     control arm, where they no longer receive contact from the CHW. Members of both groups~     receive monthly data collection calls from a Research Assistant. We hypothesize that~     participants in the control arm will experience sustained improvements in asthma outcomes as~     compared to their pre-HCWABT I levels and that participants in the CHW intervention arm will~     continue to improve in asthma control severity, quality of life, and healthcare use.~   "
5901|NCT03489642|"~     Researchers want to learn more about telehealth pulmonary rehabilitation programs that help~     people with Chronic obstructive pulmonary disease (COPD) improve physical activity and~     quality of life.~   "
5902|NCT03489629|"~     To evaluate the micro-biologic efficacy and safety of a streamlined treatment for early onset~     methicillin-resistant staphylococcus aureus (MRSA) in patients with cystic fibrosis.~   "
5904|NCT03489603|"~     Myocardial infarction is one of the leading causes of death and disability worldwide. In~     addition to standard diagnostic methods, it has been shown that high-sensitivity cardiac~     troponin assays allow greater sensitivity in the diagnosis of myocardial infarction and~     assume a central role for both exclusion (rule out) and confirmation (rule in) of acute~     myocardial infarction , while allowing to reduce the time interval between ER admission and~     presumptive diagnosis.~      Considering the relevance of this topic, we propose to conduct an observational study in real~     world clinical practice settings at Emergency Departments, aiming to evaluate clinical and~     economic aspects deriving from the use of the different quantitative assays of~     high-sensitivity cardiac troponin currently available in patients with suspected acute~     myocardial infarction and non-ST-elevation ECG (NSTEMI) on the admission, including time of~     diagnosis and number of laboratory and imaging tests performed.~   "
5905|NCT03489590|"~     An open label non-randomized study enrolling up to 20 healthy participants and up to 30~     participants with cystic fibrosis to establish a healthy versus disease comparison. Each~     participant will receive a mixture of inert gas (perfluoropropane (PFP)) in a ratio of 79%~     PFP to 21% oxygen as a contrast agent to enhance visualization of the airway and alveolar~     spaces using magnetic resonance imaging of inert gas/oxygen mixtures. The study consists of a~     screening visit followed by up to 2 study visits.~   "
5906|NCT03489577|"~     Patients admitted to the Intensive Care Unit after severe injury are prone to suffer from~     infectious complications and even sepsis. Despite tremendous efforts the etiology of this~     increased susceptibility to infectious pathogens is incompletely understood. Clinical signs~     and symptoms as well as current diagnostic clinical tests (WBC, CRP, cytokines,~     interleukines) lack sensitivity or specificity for adequate prediction of the development of~     infectious complications or sepsis.~      Neutrophil granulocytes, cells of the innate immune system, play an important role in the~     defence against invading bacterial pathogens and are crucial in preventing fulminant~     infections. For successful eradication of a bacterium neutrophils need to exert specific~     functions: chemotaxis, migration, phagocytosis, degranulation and production of radical~     oxygen species. Much research has focused on the effect of trauma on neutrophil's individual~     capacities to kill bacteria with conflicting interpretations as a result. For adequate~     determination of the neutrophil's capacity to eradicate bacteria from tissue of trauma~     patients we developed novel in-vitro assays in which neutrophils are tested for all of these~     functions combined. This assay allows us to identify dysfunctional neutrophils adequately.~      The main focus of this study is the determination of the functionality of aberrant~     neutrophils circulating in the peripheral blood of severly injured following trauma.~   "
5907|NCT03489564|"~     This Pilot & Feasibility study will test the hypothesis that pregnant women who are more~     active will have better functioning mitochondria in vivo (higher ATPmax, via 31P-MRS), which~     will be positively related to maternal and infant mitochondrial function in vitro (higher~     oxygen consumption rates in primary myotubes and umbilical cord derived mesenchymal stem~     cells, respectively). Twenty pregnant women (10 active and 10 sedentary) will be recruited in~     the first trimester of pregnancy determined from self-reported physical activity and~     assessment by activity monitors. Placental biospecimens will be collected during delivery for~     other molecular mitochondrial analyses.~   "
5908|NCT03489551|"~     This research study proposes to conduct an open label, feasibility study administering~     prophylactic oral haldol to patients undergoing a hematopoietic stem cell transplant (HSCT).~      The study will address the following research aims: 1) To demonstrate the feasibility of~     enrolling HSCT patients in a prophylactic medication trial, 2) To determine the tolerability~     of oral haldol in HSCT patients and 2) To compare rates of delirium in HSCT patients who~     receive prophylactic haldol with an untreated historical control group.~   "
5909|NCT03489538|"~     Changes in homocysteine values after bariatric surgery remain controversially discussed. This~     is the first comprehensive summary to depict timeline changes in homocysteine levels~     following laparoscopic roux-en-Y gastric bypass.~   "
5910|NCT03489525|"~     The purpose of this study is to assess the safety, pharmacokinetics and tolerability,~     describe the dose-limiting toxicities (DLTs), and determine the maximum tolerated dose (MTD)~     or maximum administered dose (MAD [in the absence of establishing the MTD]) for single agent~     MEDI2228 in adult subjects with multiple myeloma who are either transplant ineligible or post~     autologous stem cell transplant and are relapsed/refractory.~   "
5911|NCT03489512|"~     A multicentre, open-label clinical trial of two groups comparing cutaneous asepsis with~     chlorhexidine gluconate at 2% + isopropyl alcohol 70% in relation to the placement of central~     venous catheters (Study group) with standard asepsis with aqueous chlorhexidine at 2% (Group~     Control). The incidence of catheter related bacteremia, the incidence of colonization of the~     skin and the incidence of colonization of the central venous catheter will be evaluated.~   "
5912|NCT03489499|"~     Prospective observational study to analyse patients' pain related outcome after surgery and~     ist association to genetic variants and non-genetic variables.~   "
5913|NCT03489486|"~     Multicentre international prospective cohort study designed to evaluate whether preoperative~     presepsin (sCD14-ST) is associated with the composite endpoint: all-cause mortality and major~     adverse cardiovascular or cerebrovascular events (MACCE) after elevated risk non-cardiac~     surgery. If so:~        1. What is the optimal cut-off for presepsin to predict the composite endpoint all-cause~          mortality and MACCE?~        2. Does the calculated optimal cut-off improve prediction of the composite endpoint~          all-cause mortality and MACCE when added to clinical data and established biomarkers?~   "
5914|NCT03489473|"~     Endometrial cancer is the most common gynecological malignancy in the western world and its~     incidence is expected to increase in the coming years due to obesity. Major treatment~     modalities include surgery, radiotherapy and chemotherapy. Hormonal therapy can be considered~     in primary treatment if other treatment modalities are not feasible and in treatment for~     recurrent disease. Hormonal treatment has shown to be more effective in endometrial cancers~     expressing estrogen (ER) and progesterone receptor (PR). Tumor heterogeneity frequently~     causes loss of expression of ER and PR in metastasis compared to primary tumors. The FES PET~     CT scan combines PET-CT scan with an estrogen tracer, thus allowing non invasive~     visualisation of estrogen receptor, even in patients with metastasis that are difficult to~     reach for biopsy. FES PET has been shown to relate well to ER expression and to treatment~     response in breast cancer. This study explores the feasibility of the FES PET scan in~     endometrial cancer patients.~   "
5917|NCT03489434|"~     Adolescent substance use, sexual assault, and sexual risk behaviors pose a great public~     health concern, and subsequently there is also a great need to prevent these behaviors and~     experiences. This project involves the adaptation and integration of evidence-based~     prevention content aimed at preventing and reducing substance use, sexual assault, and sexual~     risk behaviors. This project uses innovative technology within primary care visits to conduct~     a feasibility trial of an integrated prevention program.~   "
5918|NCT03489421|"~     Older adults with human immunodeficiency virus (HIV) and a long history of antiretroviral~     therapy have more mitochondrial dysfunction- the cells that help them make energy. This~     dysfunction in mitochondria may lead to symptoms of muscle fatigue, physical function~     impairment, and impaired exercise tolerance compared to HIV-uninfected controls of a similar~     age and body mass index (BMI). Furthermore, the investigators hypothesize that the older~     antiretroviral therapy (ART) of tenofovir disoproxil fumarate (TDF) is associated with~     greater impairment in mitochondrial function than the newer agent, tenofovir alafenamide~     (TAF).~   "
5919|NCT03489408|"~     The purpose of this study is to collect device and procedure experience in everyday clinical~     practice. The patients are being asked to participate in this study because they are a~     surgical candidate for the treatment of a broken shoulder and are considering treatment with~     the PH Cage device.~   "
5920|NCT03489395|"~     Isolated reports have indicated that complete Left Atrial or Left Atrial Appendage thrombus~     resolution may be achieved also with use of oral Factor Xa inhibitors, which have~     demonstrated the same efficacy but a better safety profile compared to warfarin.~      The aim of this open-label pilot study is to investigate the percentage of Left Atrial /Left~     Atrial Appendage thrombus resolution with edoxaban therapy in patients with non-valvular~     atrial fibrillation. The subordinated aim is the design a larger and longer study to compare~     edoxaban and warfarin in the same patient population.~      With the exception of few case reports, there are no data in the same patient population~     referred to antithrombotic treatments other than vitamin K antagonists.~   "
5921|NCT03489382|"~     This study evaluates the effectiveness of a smartphone-assisted problem-solving therapy (PST)~     service across Emergency Departments in Ontario. A total of 25 Emergency Departments have~     been randomized to either usual care or the smartphone-assisted PST service intervention. The~     main cluster randomized controlled trial will use data collected from the Institute of~     Clinical Evaluative Sciences (ICES) to assess the impact of this service on suicides and~     re-presentations to hospital for self-harm as well as other health service use one-year post~     study launch.~   "
5922|NCT03489369|"~     This is the first study to test Sym022 in humans. The primary purpose of this study is to see~     if Sym022 is safe and tolerable for patients with locally advanced/unresectable or metastatic~     solid tumor malignancies or lymphomas that are refractory to available therapy or for which~     no standard therapy is available.~   "
5923|NCT03489356|"~     The present study explores the ability of dermatologists to influence patients' behavior~     using a novel and brief (3 minute) behavioral intervention in the context of naturally~     occurring patient interactions and shows promise for long term sustainability. The incidence~     of invasive skin cancers, cutaneous melanoma in particular, has nearly tripled in the U.S.~     between 1975 and 2004, making it the fastest rising incidence rate for all cancers in the~     United States. Dermatologists are in an ideal position to effect change in their patients.~     The present study will assess whether a brief intervention (The ABC—Addressing Behavior~     Change method) delivered to patients by dermatologists during a skin examination will~     increase the use of sun protection and reduce risk behaviors compared to patients who receive~     treatment as usual.~   "
5924|NCT03489343|"~     This is the first study to test Sym023 in humans. The primary purpose of this study is to see~     if Sym023 is safe and tolerable for patients with locally advanced/unresectable or metastatic~     solid tumor malignancies or lymphomas that are refractory to available therapy or for which~     no standard therapy is available.~   "
5925|NCT03489330|"~     In order to decrease inappropriate antibiotic use, drivers of inappropriate use must be~     identified locally. This study will focus on the MOST inappropriate use, which are defined as~     'never events'. Previous work has shown that antibiotic use clusters over time. It is~     hypothesized that never events also cluster over time. Using electronic data capture~     strategies, an algorithm will be developed to quickly and accurately identify areas of~     antibiotic use concern. Secondly, a framework will be developed, utilizing antimicrobial~     consumption data and captured signals of inappropriate antimicrobial use to provide targets~     for antimicrobial stewardship efforts.~   "
5926|NCT03489317|"~     Metabolic syndrome (MS) is defined by a manifestation of cardiometabolic risk factors~     including high blood pressure, glucose and triglycerides, low high-density lipoprotein (HDL)~     cholesterol, and abdominal obesity. It is closely associated with other diseases such as~     fatty liver and gouty arthritis. In recent years there is evidence that gut microorganisms~     are intimately linked to health and wellbeing. Here, the investigators hypothesize that gut~     microorganisms are involved in the regulation and/or onset of MS and its symptoms.~   "
5927|NCT03489304|"~     In HIV positive patients with sleep onset insomnia and receiving pharmacologic treatment for~     comorbid depression, the proposed study aims to evaluate the impact of zaleplon on sleep~     measures determined by insomnia severity index (ISI) and Epworth sleepiness scale (ESS).~   "
5928|NCT03489291|"~     This is an open-label, single-dose, single-arm, multi-center trial, with a screening, a~     treatment + post-treatment follow-up phase, and a long-term follow-up phase.~      The IMP AMT-061 is a recombinant adeno-associated viral vector of serotype 5 (AAV5)~     containing the Padua variant of a codon-optimized human FIX complementary deoxyribonucleic~     acid (cDNA) under the control of a liver-specific promoter. The IMP is identified as~     AAV5-hFIXco-Padua (AMT- 061). The pharmaceutical form of AMT-061 is a solution for~     intravenous infusion.~      The administered dose of AMT-061 will be 2 x 10^13 gc/kg.~   "
5929|NCT03489278|"~     The purpose of the Clinical Procedures To Support Research (CAPTURE) study is to utilize~     information collected in the medical record to learn more about a disease called amyotrophic~     lateral sclerosis (ALS) and related disorders.~   "
5974|NCT03488667|"~     To evaluate the antitumor activity and safety/tolerability of the combination (mFOLFOX +~     Pembrolizumab) in patients with potentially resectable adenocarcinoma of the Gastroesophageal~     Junction (GEJ) and stomach.~   "
5930|NCT03489265|"~     Accidental bowel leakage (fecal incontinence) increases in people who have diarrhea and~     sensations of urgency to have a bowel movement. Drugs such as loperamide (Imodium) that~     reduce diarrhea improve accidental bowel leakage, but loperamide has disadvantages: it is~     difficult to find a dose that does not cause constipation, and it does not reduce urge~     sensations. Eluxadoline is a new drug that is effective for reducing diarrhea, abdominal~     pain, and urgency in patients with irritable bowel syndrome, and it may be less likely than~     loperamide to cause severe constipation. Therefore, eluxadoline may help patients manage~     accidental bowel leakage caused by diarrhea. The chemical name for Viberzi® is eluxadoline.~      The primary aims of this study are to find out if eluxadoline at a dose of 100 mg orally~     twice a day will reduce the average number of days the patient has accidental bowel leakage,~     and to see if the rate of accidental bowel leakage increases when the patient stops taking~     eluxadoline. Additional goals are to find out if eluxadoline decreases diarrhea and urge~     sensations.~      This is a small (pilot) study to show whether eluxadoline is an effective way of treating~     accidental bowel leakage. If the study shows this, a larger study will be needed. There are~     three phases to this 12-week study: (1) A two-week run-in period to see if the patient meets~     the inclusion criteria. (2) Two months for treatment including one month on eluxadoline and~     one on placebo (sugar pills) twice a day. (3) A two-week follow-up to see what happens when~     you stop taking eluxadoline.~      To participate in the study, patients should be aged 18 or older. Patients with inflammatory~     bowel disease, anal fissures, or congenital malformations will be excluded.~      The primary outcome is the average number of days per week with any solid or liquid bowel~     accidents. Additional information includes: (1) Number of days per week the patient takes~     loperamide, (2) days per week with loose or watery stools, (3) days per week with moderate to~     strong urge sensations, and (4) questionnaires to measure the severity of accidental bowel~     leakage, quality of life, anxiety, and depression. There will be up to 38 patients in the~     study.~   "
5931|NCT03489252|"~     This pilot trial studies remote activity monitored by Fitbit Charge 2 in investigating daily~     step and sleep data in participants with head and neck cancer who are undergoing radiation~     therapy. A wearable remote activity tracking device, such as the Fitbit Charge 2, may help to~     detect early signs of treatment or disease-related symptoms, improve quality of life,~     decrease emergency room visits, and decrease hospitalizations in participants with head and~     neck cancer.~   "
5932|NCT03489239|"~     A research study to observe the safety, efficacy and tolerability of switching from Entecavir~     (ETV) to Tenofovir Alafenamide TAF in patients with chronic hepatitis B~   "
5933|NCT03489226|"~     Comparison of Capsimax™ 2mg and 4mg of capsicum extract vs. placebo on metabolic rate and~     satiety.~   "
5934|NCT03489213|"~     This randomized phase II trial will enroll overweight cancer survivors. Subjects in both~     groups will be educated to follow a diet pattern similar to what is recommended by the~     Dietary Guidelines for Americans and the American Institute for Cancer Research (DGA/AICR)~     but one group will also receive 18 ounces of lean beef for incorporation into a healthy diet.~     Subjects will be encouraged to exercise regularly and activity will be monitored throughout~     the study. Nutrition and exercise may help cancer survivors successfully maintain improved~     dietary patterns, body composition, and physical activity efforts and consumption of beef may~     favorably impact lean body mass and specific nutritional outcomes.~   "
5935|NCT03489200|"~     The objective of this trial is to evaluate the efficacy and tolerability of EH301 in patients~     with amyotrophic lateral sclerosis. Patients with ALS are randomized to receive either EH301~     or placebo daily and undergo active evaluation for 6 months.~   "
5936|NCT03489187|"~     The purpose of the VIVID-1 data collection study is to establish a database of clinical~     images and associated technical files from commercial cases using the Visualase Thermal~     Therapy System (VTTS). All data collected will be de-identified. No safety or effectiveness~     assessments will be completed.~   "
5937|NCT03489174|"~     Women who take opioid substitution therapy have higher rates of unintended pregnancy, more~     pregnancies, and a higher risk of pregnancy complications than the general population.~     Current practice is to test for pregnancy only at patient request or if the clinician~     suspects pregnancy. This study will compare monthly pregnancy testing to current practice in~     a double blind randomized control trial. As many women of childbearing age as possible will~     be recruited from the Hamilton Clinic for Opioid Substitutional Therapy. Women assigned to~     the intervention will have monthly testing at the same time as their monthly urine drug~     testing at the clinic. The primary objective is to assess if there is a significant~     difference is early pregnancy detection and the secondary objectives are to assess~     differences in pregnancy disposition and gestational age at entry to prenatal or abortion~     care.~   "
5938|NCT03489161|"~     The investigators are trying to determine whether they can effectively treat patients~     suffering from acute opioid withdrawal in the Emergency Department at Virginia Commonwealth~     University Health System (VCUHS) and subsequently transfer them to an outpatient addiction~     clinic within the existing infrastructure. This will be a descriptive investigation of the~     process to reveal areas of success and opportunities for improvement in order to determine~     feasibility of the study procedures in preparation for a larger clinical investigation.~   "
5939|NCT03489148|"~     Depression, anxiety, hopelessness, poor sleep quality, somatic pain, high risk of substance~     abuse, and suicide ideation are positively correlated with perceived stress. Spirituality and~     positive emotions have profound, positive impacts on health and reduce perceived stress. The~     current study is an exploration of Tamarkoz®, a Sufi practice that is a method to~     concentrate, as a pathway by which spirituality and positive emotions effect perceived~     stress. Tamarkoz® incorporates physical, emotional, and spiritual aspects of an individual.~     In its current form, it includes Movazaneh® which is movement balancing developed by the Sufi~     Master, Professor Nader Angha. Movazaneh® movements direct concentration of the mind to a~     state of collectiveness and activates electromagnetic centers in the body, which are said to~     develop spirituality in an individual. A national survey of college students indicated that~     over 80% have interest in spiritual development.~      Participants were recruited from the University of California, Berkeley for an 18-week~     quasi-experimental study with pretest-posttest and follow-up in three groups. Assessments~     were conducted with blood pressure, heart rate, the 10-item perceived stress scale, the~     38-item dispositional positive emotions scale, and the 16-item daily spiritual experiences~     scale in a Tamarkoz® group, a wait-list control, and a third group utilizing the campus~     health center's stress management resources. Blood pressure and heart rate measurements were~     taken by the researcher using a validated home monitoring device. Additionally, all~     participants provided 3 diurnal saliva samples to determine changes in salivary~     immunoglobulin A and salivary cortisol. All data were collection was through non-evasive~     procedures and were assessed at baseline, end of the school semester (12 weeks) and 18 weeks.~      Participants, diverse university students, had no prior exposure to Tamarkoz®.~   "
5940|NCT03489135|"~     This is an open label, prospective, non-randomised, multi-centre first-in-human evaluation of~     the Vetex Thrombectomy Device for treatment of acute iliofemoral deep vein thrombosis (DVT)~   "
5975|NCT03488654|"~     In systemic lupus erythematosus (SLE), cardiac manifestations, e.g. coronary artery disease~     (CAD) and myocarditis are leading causes of morbidity and mortality. The prevalence of~     subclinical heart disease in SLE is unknown. We studied whether a comprehensive~     cardiovascular magnetic resonance (CMR) protocol may be useful for early diagnosis of heart~     disease in SLE patients without known CAD~   "
5976|NCT03488641|"~     This observational study evaluates if drug response testing can be performed within 7 days~     and analyzes the value of ex-vivo drug screening for hematological malignancies as a~     biomarker to predict outcome, clinical course and response to treatment.~   "
5941|NCT03489122|"~     The proposed study addresses a gap regarding the need for effective Major Depressive Disorder~     (MDD) treatments and the 40% of individuals treated with antidepressant medications that do~     not achieve full remission. This study tests a novel approach for treating MDD in a~     Randomized Control Trial (RTC) using yoga versus walking interventions to correct an~     imbalance in the Autonomic Nervous System; an over active Sympathetic Nervous System (fight~     or flight) an underactive Parasympathetic Nervous System (PNS) (rest, renewal and social~     engagement) and associated under activity in the neurotransmitter, gamma aminobutyric acid~     (GABA). This novel approach is complimentary to the use of antidepressant medications that~     primarily target the monoamine systems. Low activity in the PNS and GABA systems are also~     found in MDD, PTSD, and Alcohol Use Disorder, disorders representing a high healthcare burden~     in the Veteran population. This intervention has potential to provide relief for MDD and~     other disorders relevant the Veteran population~   "
5942|NCT03489109|"~     Background:~      Weight gain can lead to obesity and diabetes even in people living with human~     immunodeficiency virus (HIV). Researchers want to see if the technique intermittent calorie~     restriction can help overweight people with HIV as an alternative to traditional diets.~      Objective:~      To see if intermittent calorie restriction leads to weight loss and improved blood sugar in~     obese people with HIV.~      Eligibility:~      Adults ages 18-65 with HIV who are obese and do not have diabetes~      Design:~      Participants will be screened with a medical history, physical exam, and blood and urine~     tests.~      Before starting treatment, participants will:~        -  Have a nutritional consultation~        -  Get a pedometer to record daily steps~        -  Test a restricted diet for 1 day~        -  Have a body x-ray~      At the baseline visit, participants will have:~        -  Blood drawn after they drink a sugar drink~        -  Questions about their health and eating~        -  A nutritional consultation~        -  Resting energy expenditure measured. Participants will fast overnight. Then they will~          lie down while a plastic bubble goes over the head and a plastic sheet covers the upper~          body. Oxygen flows into the bubble.~        -  Liver stiffness test. A wand on the stomach releases sound waves like an ultrasound.~      For 12 weeks, some participants will be on a standard diet. Others will restrict how much~     food they eat 2 days a week. On those days they will eat about 25% of their recommended~     calories.~      Participants will keep a diary of their diet and steps.~      Participants will have 4 visits during the 12-week diet and 1 visit 12 weeks after the diet~     ends. They will repeat previous tests.~   "
5943|NCT03489096|"~     Pulmonary vein isolation (PVI) using cryoballoon ablation is a well-established procedure for~     the treatment of atrial fibrillation (AF). However, the use of cryoballoon ablation in recent~     clinical trials have been limited to PVI. As such, patients with paroxysmal AF have been the~     main recipients of this procedure. In patients with persistent AF, or patients with~     paroxysmal AF and significant AF substrate other than the pulmonary veins, the utility of~     cryoballoon ablation is less straightforward. In such patients, the choices are to either use~     cryoballoon ablation in a PVI-only approach or alternatively, use cryoballoon ablation for~     PVI followed by the use of radiofrequency ablation for additional ablation and/or substrate~     modification.~      Substrate modification by targeting left atrial fibrosis detected on delayed enhancement~     magnetic resonance imaging (DE-MRI) is an increasingly popular approach with growing data~     showing its utility to decrease the risk of recurrence. The ability to use cryoballoon~     ablation for fibrosis based ablation in addition to PVI will therefore provide a significant~     advantage.~      This study will evaluate feasibility and the outcome of targeted ablation of left atrial~     fibrosis detected on DE-MRI in addition to pulmonary vein isolation using the Arctic Front~     Advance Cryoballoon Catheter.~   "
5944|NCT03489083|"~     The aim of this study was to compare the heat shock response (HSR) between healthy~     middle-aged adults, healthy elderly adults and type 2 diabetic elderly people. In addition,~     considering the effects of strength exercise in promoting health, we aimed to test the~     effects of strength training over the HSR in diabetic elderly people. Thirty (19 females and~     11 males) sedentary non-smoking participants volunteered for this study (11 healthy~     middle-age adults, 7 healthy old adults and 12 diabetic old subjects, previously diagnosed by~     their personal physicians).~      Firstly, venous blood samples were obtained from all participants to test the HSR. They were~     divided in three groups: healthy middle-age adults (45-59 y.o.), healthy elderly adults and~     elderly diabetic (> 60 y.o.). As we identify that diabetic people presented a poor HSR, we~     submit the diabetic group to a twelve-week resistance exercise training to verify if this~     intervention could improve the HS response.~      Diabetic subjects were randomly (1:1 block randomization) allocated in one of the two groups:~     Trained and Control (no training). Strength training was performed three times per week while~     the control group performed a placebo stretching/relaxing session once a week (for~     adherence purposes). Both interventions had twelve weeks of duration. To avoid any~     significant adaptation, all stretching exercises (for large muscle groups only) were~     performed at very low intensity without any significant discomfort.~      Supervised (by qualified sport and exercise scientists) exercise was performed in a gym on~     three non-consecutive days of the week. Each session lasted ~60 min and consisted of a warm~     up, the resistance exercise training and a cool down. The training programme consisted of a~     combination of upper and lower body exercises using gym equipments, free weights and body~     weight as the primary resistance. The twelve weeks of strength training were divided into~     three mesocycles of four weeks each. Exercises included leg press, knee extensions and leg~     curls, biceps curls, triceps extensions, lat pull-downs, shoulder press, bench press and~     abdominal crunch. Before the start of the training period, subjects completed a~     familiarization session to practice the exercises they would further perform during the~     training sessions, where the exercise load was individually tested. The resistance training~     was performed using two to three sets per exercise at intensities between 12-15 repetition~     maximum-RM.~   "
5945|NCT03489070|"~     Topical hemostats are agents that stop bleeding by contributing blood to clot. Oxidized~     cellulose, a sort of mechanical hemostatic material, predominantly forms a block to stop the~     blood flow and provides a surface to clot more rapidly.It was marketed for the first time in~     1945 and widely used for its convenience, biocompatibility, and bactericide from that time.~     It is currently available in many commercial products, while manufactured using either a~     regenerated or nonregenerated process. The physicochemical property and hemostatic efficacy~     of oxidized regenerated cellulose (ORCG) and oxidized nonregenerated cellulose (ONRCG) has~     been well documented using in vitro test and animal models, and ONRCG was seemingly superior~     to ORCG in terms of hemostasis. However, no clinical study has been performed to verify.~     Therefore, the objective of this prospective randomized study is to assess the hemostatic~     efficacy of ORCG (Surgicel®, Ethicon) vs ONRCG (Traumastem®, Bioster) for hemostasis of local~     bleeding in patients undergoing hepatic resection.~   "
5946|NCT03489057|"~     In this study, the investigators propose to test the efficacy of a couple-focused, web-based~     tailored prostate cancer symptom management program, Prostate Cancer Education and Resources~     for Couples (PERC) in a randomized clinical trial. A two-group (PERC versus National Cancer~     Institute (NCI) website plus treatment as usual) randomized controlled design will be used,~     and data will be collected at baseline (T1), 4 (T2), 8 (T3), and 12 months (T4) among 250~     patients completing initial treatment for localized prostate cancer and their intimate~     partners.~   "
5947|NCT03489044|"~     The study proposed aims to evaluate the effect of Levetiracetam in patients with Alzheimer's~     disease (AD) in a Phase 2 Clinical Trial.~      Levetiracetam is an established anti-epileptic medication that has been approved by NICE (UK)~     as a first line treatment for focal epilepsy. Levetiracetam is now generic and acts, as all~     anti-epileptic medications do, by stabilising neuronal networks. However, Levetiracetam~     appears unique amongst the anti-epileptic medications in being able to stabilise aberrant~     neuronal networks in Alzheimer's disease. In both animal models of AD and in patients with~     mild cognitive impairment, Levetiracetam can offer benefit to cognition.~      The investigators therefore aim to test whether Levetiracetam, through stabilisation of~     neuronal networks, may offer benefit to cognition in patients with AD.~   "
5948|NCT03489031|"~     Multicentric, observational, cross-sectional study in Italy. The aims are to evaluate the~     basal/total ratio of daily insulin dose (b/T) in diabetic outpatients type 1 (T1) and type 2~     (T2) on basal-bolus regimen, by investigating whether there is a relationship with HbA1c and~     episodes of hypoglycemia.~   "
5949|NCT03489005|"~     The purpose is to evaluate the effect of single therapeutic (400 mg) and supratherapeutic~     (1200 mg) doses of BIA 5-1058 on the time-matched change from baseline in placebo-adjusted~     interval corrected (QT) for heart rate (HR)~   "
5950|NCT03488992|"~     The purpose of this study is to investigate the health benefits of a recently developed~     multimineral/multivitamin/phytochemical (MVM/phytochemical) nutritional supplement. This~     newly developed supplement - an advancement of a previous formula designed to enhance human~     health by providing RDA-levels of essential vitamins and minerals - contains eight~     phytochemicals selected to address fruit and vegetable undernutrition, and chosen on the~     basis that: 1) published research from cell culture, animal model and, when available, human~     clinical work, suggests that it may benefit human health, and 2) it is considered safe for~     human ingestion at proposed levels of consumption.~   "
5951|NCT03488979|"~     Heart failure is a common, costly, and disabling condition characterized by recurrent~     exacerbations. Episodes of acute decompensated heart failure (ADHF) account for the largest~     proportion of admissions and 30-day readmissions to US hospitals. Medication nonadherence and~     dietary/fluid nonadherence have been associated with re-admissions. Hand-carried ultrasound~     (HCU) devices are portable, relatively inexpensive, and can augment the physical exam in the~     assessment of volume status. Dilated Inferior Vena Cava (IVC) with poor collapsibility~     correlates with elevated central venous pressure, which may be correlated with earlier~     readmission for ADHF.~      Study design to measure maximum IVC diameter (IVC max) in mm and the degree of IVC~     collapsibility with inspiration on qualitative assessment in approximately 100 patients~     admitted with ADHF. The co-investigator will share the IVC images and interpretation with~     educational intervention group patients in real time; IVC images and interpretation will not~     be shared with control group patients. Study team will assess whether sharing these IVC~     measurements correlates with greater adherence to heart failure self-management after~     discharge, as measured by the administration of the Medical Outcomes Study Specific Adherence~     Scale, modified to a 3-item version relevant for patients with heart failure (MOSSAS-3HF) at~     4 weeks after discharge. Study team will also assess for any difference in 30-day readmission~     rates for intervention vs. control group patients.~   "
5952|NCT03488966|"~     The purpose of this study is to evaluate the effects of Mindfulness Based Eating Awareness~     Training (MB-EAT) for patients who have had bariatric surgery on their weight and mental and~     physical health compared to patients who do not do this group. All participants will complete~     questionnaires evaluating eating and mental health before and after the group and 6 and 12~     months later. They will have blood pressure readings at these times and complete a~     questionnaire about their digestive health. Our hypothesis is that participants will maintain~     their weight loss after bariatric surgery and have improvements in the other outcomes.~   "
5953|NCT03488953|"~     Nearly one third of patients with colorectal cancer develop liver metastases. It is well~     known that the achievement of a R0-situation is one of the most important factors for a~     positive long-term outcome. Despite further advantages in multimodal treatment concepts, only~     20 - 30 % of the patients with metastases can be resected in curative intention.~      Recent studies, especially from Norway, have shown that liver transplantation might be a~     feasible option in well selected patients since the complete hepatectomy with subsequent~     liver transplantation can be an option for the achievement of a R0 situation.~      In this study, we pursue the strategy of two-stage hepatectomy combined with a left-lateral~     living donor liver transplantation.~      Inclusion criteria are as follows: non-resectable liver metastases of a primary colorectal~     carcinoma with an assumed portal-venous drainage of the tumor and at least a stable disease~     after a period of eight weeks systemic chemotherapy. Patients are excluded from the study if~     there is an extrahepatic tumor burden (with the exception of resectable lung metastases) or~     if the patient is not suitable for liver transplantation due to co-morbidities.~      The transplantation itself will be undertaken as a living donor liver transplantation where~     the left lateral liver lobe (liver segments 2 & 3) from a healthy volunteer donor will serve~     as graft. Prior transplantation, a left hemihepatectomy in the recipient is performed and the~     left lateral graft will be transplanted in this position. At the end of the transplantation~     procedure, the right portal vein will be closed to induce a rapid growth of the graft. The~     second step, and therefore the completion of the operation is performed after a growth period~     of the transplanted left-lateral lobe: in this procedure, the right hemi-liver of the~     recipient will be removed and the patient is supposed to be free of tumor at this point in~     time.~   "
5954|NCT03488940|"~     The intestine is the most vulnerable target organ in septic patients and is the first to be~     damaged organ in multiple organ dysfunction syndrome(MODS). Therefore, improving intestinal~     motility and mucosal barrier function is critical to the treatment of sepsis. Many studies~     have shown that, early enteral nutrition(EN) in patients with sepsis helps prevent and treat~     intestinal dysfunction, reducing ICU mortality and length of stay in ICU. However, there is~     little research on feeding methods. In this study we will compare the outcomes of different~     feeding methods: continuously-pumped in 24 hours, continuously-pumped in 16 hours and~     intermittently-pumped through the stomach tube. The aim of this study is to investigate the~     effects of different feeding methods on intestinal function in septic patients.~   "
5955|NCT03488927|"~     The purpose of this randomized controlled trial is to evaluate an intervention, Supporting~     Survivors and Self: An Intervention for Social Supports of Survivors of Partner Abuse and~     Sexual Aggression (SSS). SSS trains potential recipients of IPV or SA disclosure on the best~     methods of responding to a victim's disclosure. Consenting college students will be~     randomized into the SSS intervention or a wait-list control condition. Evaluation data will~     be multi-informant (i.e., data from both informal supports and victims) and multi-method~     (i.e., qualitative and quantitative). The investigators hypothesize that individuals~     receiving the SSS intervention, compared to individuals in the wait-list control condition,~     will provide less negative and more positive social reactions to victims' disclosure.~   "
5957|NCT03488901|"~     Gestational trophoblastic tumors are characterized by their development from placental tissue~     and their high invasive and metastatic potential. These are rare tumors (1/50 000~     pregnancies) affecting young women for whom conservative fertility treatments are preferred.~     The therapeutic strategy is based on a chemotherapy whose choice of protocol is based on a~     clinico-biological score, FIGO score, which includes tumor size, gonadotropic chorionic~     hormone level used as quantitative tumor marker, number and localization. metastases. A FIGO~     score ≤6 allows the use of monochemotherapy (methotrexate) with a 5-year survival of~     approximately 99.7%. Scores of 7 to 12 and ≥13 require multidrug therapy (EMA-CO) and are~     associated with 5-year survival of 95.1% and 61.6%, respectively.~      The chemotherapies currently used for the treatment of trophoblastic tumors have been~     described between the 1950s (methotrexate) and the 1980s (EMA-CO) and have a well documented~     toxicity regarding the risk of secondary tumors, early menopause or even death by toxicity. .~      To date, apart from the FIGO score, there is no predictor of resistance to chemotherapy in~     gestational trophoblastic tumors. However, among patients with a FIGO score ≤6 and receiving~     methotrexate in the first line, 9 to 46% will have a resistance and require a second line of~     treatment. Similarly, if the score is ≥7, 10 to 30% of patients receiving EMA-CO will require~     at least a second line of multidrug therapy.~      The hypothesis of PrediCTTro study is that tissue samples of gestational choriocarcinoma~     present a transcriptomic profile associated with the risk of further resistance to single or~     multiagent chemotherapy.~      The objective of PrediCTTro is to identify a transcriptomic signature able to predict~     resistance to single or multiagent chemotherapy.~   "
5958|NCT03488888|"~     Breast augmentation surgery is the top cosmetic surgery in USA with more then 300.000 cases~     performed annually. Pain is a common complications of the procedure accompanied of dyspnea~     and nausea due to the surgical manipulation.~      Several anesthetic techniques were developed with the objective of providing optimal surgical~     conditions together with enhanced recovery and post-op pain management.~      Pectoralis major block was first described in 2011 by Blanco in female patients undergoing~     oncologic procedures in the anterior thoracic wall.~      The investigators hypothesized if the Pectoralis Major block combined with general anesthesia~     standard techniques could be beneficial in improving pain scores and opioid consumption~     during post operative period of patients undergoing breast augmentation surgery.~   "
5959|NCT03488875|"~     In a sample of 120 officers from Dane County law enforcement agencies, the investigators are~     conducting a randomized controlled trial of an 8-week mindfulness-based training program for~     police officers, Madison Mindfulness-Based Resilience Training (mMBRT), and investigating the~     impact of this training on subjective responses to stress, stress-related psychological and~     physical health outcomes, and biological and behavioral correlates of perceived stress. While~     the benefits of mindfulness-based interventions have been documented in a variety of~     populations, this will be the largest and most comprehensive study of its kind of law~     enforcement personnel. In addition to self-report measures, this study assesses an array of~     objective biological and behavioral outcomes both in the laboratory and in the field that may~     speak to mechanisms of change involved in symptom reduction.~   "
5960|NCT03488862|"~     Purpose: The purpose of this trial is to investigate whether a microfluidics assay can detect~     trace amounts of residual leukemia and predict relapse in acute myeloid leukemia (AML)~     patients in remission who have undergone allogeneic stem cell transplantation (SCT) or~     Induction and Consolidation Chemotherapy (ICC) at the North Carolina Cancer Hospital (NCCH).~      Procedures (methods): A total of 40 eligible subjects will be treated per standard of care~     with either SCT or induction and consolidation chemotherapy (ICC) based on the appropriate~     AML treatment paradigm for their disease. Peripheral blood (10 ml) for microfluidic chip~     analysis and possible Immune Monitoring Core Facility analysis will be collected along with~     routine lab draws prior to SCT. Patients in remission after SCT or those with confirmed~     remission by bone marrow biopsy after induction chemotherapy will be followed for 1 year; and~     peripheral blood (20 ml) will be collected to assess MRD by standard methods or by~     microfluidic chip analysis on a monthly basis. In addition, bone marrow biopsies will be~     performed at the end of consolidation (typically 5 months from remission), and at 1-year post~     remission in non-transplant patients. In transplanted patients, bone marrow biopsies will be~     collected at + 30 days, + 90 days, +180 days, and +360 days after SCT.~   "
5961|NCT03488836|"~     extrusion of infected dentin into the periapical tissue has been suggested as a major source~     of pain after endodontic treatment. Although debris extrusion is an inevitable finding even~     when instrumentation is limited to the confines of the canal, different armamentarium seem to~     be associated with different amounts of debris extrusion. Studies on the effect of various~     rotary files on post-endodontic pain are very few and have yielded conflicting results with~     some favoring full-sequence and others leaning towards reciprocal rotary systems. This study~     aims at assessing the intensity of post-endodontic pain following two different rotary~     systems, Reciproc and race.~      Methods: in this single-blind, parallel-grouped randomized clinical trial a total of 150~     otherwise healthy patients aged between 20 to 50 years old with a pulpal status of~     irreversible pulpitis for one tooth in the upper or lower molar region were analyzed. A~     clinician performed the endodontic treatment in two groups, a group instrumented using race~     and a third group with instrumentation performed using Reciproc rotary systems.~   "
5977|NCT03488628|"~     High-Flow Nasal Oxygen (HFNO) therapy has never been tested against Noninvasive ventilation,~     the reference standard therapy for acute exacerbation of chronic obstructive pulmonary~     disease (COPD), in randomized clinical trials.~      The aim of the present study is to compare the effects of HFNO therapy on arterial blood gas~     variables over the first 24 hours of therapy, to those of Noninvasive ventilation, in~     patients experiencing a moderate (i.e. with arterial pH within 7.25-7.35) exacerbation of~     COPD.~   "
6003|NCT03488290|"~     The study has both quantitative and qualitative components.~      The objective of the quantitative study is:~      To evaluate the effectiveness of Learning Through Play (LTP) Plus culturally adapted Trauma~     Focused Cognitive Behavior Therapy (TF-CBT) for post-traumatic stress symptoms in parents.~      The objective of the qualitative study is:~      To find out facilitators and barriers from the perspective of the participants, clinicians,~     GPs and people delivering the LTP plus TF CBT intervention.~   "
8860|NCT03450876|"~     Study of late physical, psychological and social effects in patients treated with ipilimumab~     for advanced (stage IV or unresectable stage III) melanoma.~   "
5962|NCT03488823|"~     With increasing age, arterial endothelial cell function is impaired, which is associated with~     decreased regeneration response and increased intimal hyperplasia after endothelial injury.~     Dietary flavanols can reduce endothelial dysfunction acutely and chronically, but the exact~     mechanism is unknown. Recent studies suggest that flavanols may affect important endothelial~     regeneration response processes and possibly mediate long-term positive vascular effects. The~     aim of this study is to investigate age-dependent mechanisms of impaired endothelial~     regeneration and the influence of dietary flavanols on them. For this purpose, younger and~     old male patients, who are clinically indicated for elective transradial catheterization,~     will get periinterventional a test drink , which is rich on flavonols (800 mg flavanols~     daily), or control drink. Administration of drinks is randomized and double-blind. The test~     drinks should be given one week before the elective catheter examination until 1 week later.~     The endothelial regeneration is to be investigated as endothelium-dependent vasodilation~     non-invasively in the area of the puncture site on the forearm and by means of biomarkers in~     the blood. The endothelial function of the Arteria radialis will be measured with Flow~     Mediated Dilation (FMD) before and 24 h after catheterization. One month after~     catheterization patients undergo ultrasound examination of arteria radialis, to include~     structural vessel wall changes as intimal media thickness.~   "
5963|NCT03488810|"~     The main objective of the trial to determine if the combination of apalutamide with 6 months~     of androgen deprivation therapy by LHRH agonists in patients with intermediate and limited~     high-risk, localized prostate cancer receiving primary radiation therapy (RT) results in an~     improvement of disease-free survival (DFS) evaluated by the treating physician, in comparison~     to the combination of radiation and androgen deprivation therapy without the addition of~     apalutamide.~   "
5964|NCT03488797|"~     Children with congenital heart diseases (CHD) often show reduced health related physical~     fitness as well as limitations in gross and fine motor skills/development. Intervention~     programs in childhood are still rare and often focus just on the improvement of cardiac~     outcomes or exercise capacity. Web-based interventions, as a useful alternative to training~     manuals or supervised training, are cost effective and allow a customization of training~     times. Primary purpose of this study is to improve health related physical fitness in~     children with congenital heart disease.~   "
5965|NCT03488784|"~     This is an observational study, no drug (marketed or investigational) will be provided as~     part of the study, and the study procedures will have no impact on the medical care delivered~     to patients participating in this study. The overall study data collection period is planned~     to last up to 5 years with assessments occurring at baseline, and every 6 months thereafter~     for a total period of 3 years.~      Medical records for enrolled patients will be abstracted at baseline and annually to obtain~     clinical information, and data will be recorded for the study. Eligible patients will be~     asked to provide informed consent and to complete semi-annual patient surveys and functional~     assessments. The patient surveys will include selected PRO instrument(s) along with~     additional questions to characterize the patient's perception of disease.~   "
5966|NCT03488771|"~     All kidney transplant recipients require immunosuppression, the net level of which is~     difficult to assess. Current practice in assessing immune reactivity is to monitor levels of~     some immunosuppressive drugs. QuantiFERON Monitor® (QFM) is an in vitro diagnostic test that~     detects interferon-γ (IFN-γ) release in peripheral blood. Its clinical utility in assessment~     of the net state of immunosuppression in kidney transplant recipients has not been well~     studied. The aim of our study is to evaluate the discriminating value of QFM testing results~     for infection and rejection in a single-centre cohort of kidney transplant recipients.~   "
5967|NCT03488758|"~     To assess parental perceptions on infant feeding behavior and enjoyment with a goat milk~     formula compared to a cow milk formula~   "
5968|NCT03488745|"~     A cancer diagnosis affects not only patients but also their caregivers. The purpose of this~     study is to test the feasibility of using a mobile app suite, IntelliCare, to improve the~     mental health of cancer patients and caregivers.~   "
5969|NCT03488732|"~     Patients undergoing transcatheter valvular interventions will be prospectively included into~     the present registry. Baseline, procedural and follow-up data will be collected and analyzed~     to adress various issues in the field of percutaneous valvular interventions.~   "
5970|NCT03488719|"~     A Phase 1 Study to Examine Pharmacodynamic Interaction Between Tesofensine and Metoprolol on~     24-hours Mean Heart Rate~   "
5971|NCT03488706|"~     Prostate cancer screening with PSA is plagued by high rate of unnecessary prostate biopsies,~     especially in the gray zone (4.00ng/ml e 10.99ng/ml). We introduce a new~     circulating-tumor-cell (CTC) biomarker for detection of prostate cancer in patients in the~     PSA gray zone level, with the clinically verified potential to substantially decrease the~     number of unnecessary prostate biopsies.~   "
5972|NCT03488693|"~     The purpose of this study is to compare the effects on low risk breast cancer receiving usual~     care that includes regional radiation therapy, with receiving no regional radiation therapy.~     Researchers want to see if not giving this type of radiation treatment works as well at~     preventing breast cancer from coming back.~   "
5973|NCT03488680|"~     Child under nutrition is a major risk factor for ill health and mortality, contributes~     substantially to the burden of disease in low-income and middle-income countries and is~     associated with close to half of all child deaths. The prevalence of both underweight and~     stunting is highest in Africa and South-Central Asia. Ethiopia is one of the poorest~     countries in Sub- Saharan Africa, and child malnutrition is a serious public health problem~     where the rates for stunting (40%), underweight (25%) and wasting (9%) among children under 5~     years are among the highest in the world.~      Globally, about 40% of child mortality less than two years is associated with inappropriate~     feeding practices. Optimal breastfeeding and appropriate complementary feeding could prevent~     13% and 6% under-five mortality, respectively. Over two third of malnutrition is associated~     with inappropriate feeding practices during the first year of life.~      The first two years of life provides a critical window of opportunity for ensuring~     appropriate growth and development of children from generation to generation through optimal~     feeding. Hence, the objective of this study to evaluate the effectiveness of behavior change~     communication on optimal complementary feeding through community level actors in improving~     feeding practice, health and nutritional status of infants.~      A cluster-randomized controlled trial which was conducted in West Gojjam Zone, Northwest~     Ethiopia from May 9, 2016 to October, 2017. Behavior change communication on complementary~     feeding was conducted in the intervention kebeles/villages for 8 months. A validated~     interviewer administered structured questionnaire was used for collecting information on the~     study subjects both at the baseline and after intervention. Data will be checked, coded and~     double entered using EPI info and exported to SPSS version 21 for statistical analysis.~      The output of the study findings could be useful for health and nutrition policy makers and~     other concerned bodies in decision making and to design effective intervention strategies to~     improve feeding practices thus mitigating child malnutrition and improving their health and~     growth. The total budget needed to conduct the study is 7,000 US dollar.~   "
5978|NCT03488615|"~     The fall is a complex process associated with high morbidity and mortality, with an~     institutionalization rate of up to 40% and a major socio-economic impact.~      The prevalence of falls increases with age. In fact, it is estimated that one-third of people~     over 65 and 50% of those over 80 living at home fall at least once a year, half of whom fall~     repeatedly.~      For all these reasons, the fall is a frequent reason for emergency consultation, and is an~     integral part of geriatric syndromes at risk of early readmission.~      The care of the elderly patient has been the subject of good practice recommendations by the~     Health Authority (HAS) in 2009, with the aim of referring patients to specialized geriatric~     care. Among these recommendations is the need to look for signs of geriatric severity of~     falls.~      To our knowledge, few studies have investigated the applicability of HAS recommendations with~     the practice of emergencies; this study is part of a project to improve practices.~      - Hypothesis : Due to the fast pace of emergency medicine, the complexity of elderly patients~     and the inherent limitations of the care system, we hypothesize that few serious fallers are~     included in the geriatric pathway after admission to the emergency room (ER).~   "
5979|NCT03488602|"~     This study evaluates whether a Family-centered suicide prevention strategy, when added to~     usual care (F-SPS + UC), is more effective than enhanced usual care (EUC) in reducing~     suicide-related behaviors in 128 youth at high-risk of suicide. Half of the participants will~     be randomized to receive F-SPS + UC and half will receive EUC.~   "
5980|NCT03488589|"~     Hepatitis E is the fifth known human viral hepatitis and is probably the most common cause of~     acute viral hepatitis in the world. The incidence of acute hepatitis E is estimated at 3~     million human cases per year worldwide, with around 70,000 deaths. Most cases occur in~     endemic countries, but the number of cases in low-endemic areas has increased. HEV~     seroprevalence is high in developing countries, such as India and Southeast Asia, ranging~     from 27-80%. Acute disease mortality is 1-4%, with risk being higher in pregnant women and~     immunodeficient patients.~      The four more prevalent genotypes are allocated into two groups. Epidemic hepatitis E~     includes genotypes 1 and 2, which are considered human viruses and have caused the epidemics~     of hepatitis. These forms are transmitted mainly by contaminated water and the fecal-oral~     route. endemic hepatitis E includes genotypes 3 and 4, which are considered swine viruses~     (common in domestic and wild pigs), capable of infecting humans as an accidental host and~     therefore considered zoonotics.~      The course and clinical presentation of hepatitis E is highly variable. The detailed~     mechanisms that lead to the different clinical outcomes in hepatitis E are only partially~     understood. It is known that both viral factors (genotype and dose of inoculum) and host~     factors (presence of previous liver disease, pregnancy and distinct genetic polymorphisms)~     determine the course of infection. In most cases, hepatitis E causes self-limited illness,~     lasting from a few days to weeks, with an average of 4-6 weeks. However, in developed~     countries it can cause chronic disease with rapid progression to cirrhosis, especially in~     patients who are transplanted, have hematological malignancies requiring chemotherapy, or~     have infection with HIV.~      Hepatitis E is an underdiagnosed disease, partly due to the use of serological tests with low~     sensitivity. Diagnosis can be made indirectly by detecting antibodies against HEV in the~     serum, or directly by detecting the genome of the virus in blood or other body fluids. The~     tests for anti-hepatitis E antibody screening are commercially available, but none of them~     has been approved by the Food and Drug Administration (FDA). Unfortunately, the sensitivity~     and specificity of these tests vary greatly and this could explain the discrepancies in rates~     of anti-hepatitis E antibodies published for the various populations studied. The tests for~     viral RNA in serum and feces are confirmatory, but still experimental.~   "
5981|NCT03488576|"~     To compare the retinal sensitivity of complete internal limiting membrane (ILM) peeling~     versus foveal sparing ILM peeling during vitrectomy for epiretinal membrane or macular hole.~   "
5982|NCT03488563|"~     This is a prospective, randomized, vehicle‐controlled, double‐blind, multi-center study~     assessing the safety, tolerability, and efficacy of B244 delivered as an intranasal spray for~     preventive treatment in subjects with episodic migraine.~   "
5983|NCT03488550|"~     This is a multi center, open-label, single dose, safety study. Approximately 9 to 15~     participants with open-angle glaucoma are assigned into 3 sequential dose-levels and will~     receive ANX007 administered as single, IVT injections.~   "
5984|NCT03488537|"~     Colorectal cancer (CRC) is the third most common new cancer diagnosis and a major cause of~     morbidity and mortality throughout the world. Early detection and treatment are critical~     factors in the course and prognosis of CRC, and screening programs have proven to be an~     important means to reduce both CRC related mortality and secondary economic burden.~      The diagnostic accuracy of non-invasive screening tests is still limited and a follow-up~     colonoscopy is required for confirmation of the diagnosis. The faecal occult blood test (FIT)~     is the most commonly used fecal screening test worldwide, but sensitivity for CRC ranges~     between 53%-99% depending on the cut-off values used, whereas sensitivity for advanced~     adenomas is disturbingly low (39%-57%).~      The aim of this study is to evaluate the diagnostic accuracy of the AeonoseTM to distuinguish~     people with CRC from healthy controls.~   "
5985|NCT03488524|"~     This study will provide extended access to patients and assess longer-term outcomes on~     patients who have completed the Centaur study.~   "
5986|NCT03488511|"~     Malnutrition is still a big problem in hospitals since 2-38% of clinical patients is~     malnourished, because of the underlying disease as well as its treatment. An adequate~     nutritional status before surgery is essential in order to improve recovery after surgery.~     Therefore, the investigators hypothesize that providing meals from FoodforCare at Home before~     surgery will contribute to functional and clinical outcomes of patients when compared to~     usual care.~   "
5987|NCT03488498|"~     It is typical of chronic low back pain that, after the first painful episode, is repeated at~     44-78% of patients. For acute lumbar pain, approx. 10-15% of them are converted into chronic.~     Conservative treatments are few studies done in the traction therapy. A large number of~     multicenter trials did not evaluate the effectiveness of underwater traction therapy.~   "
5988|NCT03488485|"~     Background and Aims: The prevalence of hepatitis C virus infection (HCV) infection in Punjab,~     India is 3.29%, with an estimated burden of around 650,000 viremic chronic HCV (CHC)~     patients. The Mukh Mantri Punjab Hepatitis C Relief Fund (MMPHCRF) was launched in June 2016~     to provide free treatment to all CHC aiming to eliminate HCV from Punjab. The study assessed~     the feasibility of decentralized care and efficacy and safety of 12 or 24 weeks of sofosbuvir~     (SOF) + ledipasvir (LDV) or SOF + daclatasvir (DCV) ± ribavirin (RBV) in the treatment of CHC~     patients in a public health care setting.~   "
5989|NCT03488472|"~     This study is a prospective single arm trial designed to study the safety and effectiveness~     of a medical device, NovoTTF-200A, used with stereotactic radiosurgery (SRS) in subjects with~     brain metastases from small cell lung cancer (SCLC).~   "
5990|NCT03488459|"~     The aim of this study was to analyze a relationship between information support provided by~     an interdisciplinary team and the levels of anxiety, pain and satisfaction with postoperative~     analgesia in children and adolescents subjected to thoracic surgeries.~   "
5994|NCT03488407|"~     Primary percutaneous coronary intervention is the preferred treatment for patients with~     ST-segment acute coronary syndrome. The radial access is an established approach, associated~     with a reduction in vascular access related complications after primary percutaneous coronary~     interventions. The purpose of this study is to examine the baseline characteristics, risk~     factors, procedural parameters and complications in patients with STEMI taken for primary~     angioplasty by radial access.~      Data of all patients with acute STEMI with primary PCI through radial access is to be~     evaluated for baseline characteristics and procedural parameters and complications. Patients~     in the prospective study are followed up till discharge and any in-hospital complication~     noted.~      This was a prospective, observational and descriptive study. Three hundred fifteen~     consecutive patients with an ST-segment elevation acute myocardial infarction (STEMI) treated~     with primary angioplasty by radial access, admitted between March 2016 and Feb 2017 were~     analyzed for their baseline characteristics, risk factors, and procedural parameters,~     complications and outcomes. High risk sub-groups analysis was also done. High risk groups~     includes patients with age >75yrs, cardiogenic shock, severe LV systolic dysfunction, acute~     left ventricular failure, high degree AV block, right ventricular infarction and low BMI. The~     study is conducted among patients with acute STEMI, considered for primary PCI through radial~     artery access at operator discretion.~      This study analyzed the baseline characteristics of patients which includes clinical history,~     clinical examination, ECG, 2D ECHO, coronary angiogram to evaluate cardiovascular risk~     factors.~   "
5995|NCT03488394|"~     This is a phase I/II study evaluating safety and efficacy of autologous hematopoietic stem~     and progenitor cells genetically modified with IDUA lentiviral vector encoding for the human~     α-L-iduronidase gene for the treatment of patients affected by Mucopolysaccharidosis Type I,~     Hurler variant~   "
5996|NCT03488381|"~     Repetitive head impacts in sports and military may cause deleterious effects in the nervous~     system. Investigators' previous works in football players have shown promising results in~     prediction of concussion and prevention of long-term defect using eye-movement paradigm~     (ocular-motor system) and blood biomarker. However, acute head impact effects on~     aforementioned parameters remain unknown. Thus, to answer a critical research question that~     whether or not ocular-motor system and brain-derived blood biomarker may be acutely altered~     following 10 successions of controlled soccer heading. To answer the question, investigators~     hypothesized that acute bout of soccer heading will not elicit noticeable change in subject's~     symptoms but to induce a transient defect in the ocular-motor system and increase plasma~     expression of brain-derived biomarker.~   "
5997|NCT03488368|"~     IgA nephropathy (IgAN) is the most prevalent form of primary glomerulonephritis in the~     Western world. Although most IgAN patients take a benign longterm course, about 20-30%~     progress to end-stage renal disease (ESRD) over 20 years. The majority of current treatment~     recommendations is based on weak evidence.~      In the randomized, controlled Supportive Versus Immunosuppressive Therapy for the Treatment~     Of Progressive IgAN (STOP-IgAN) trial, the investigators analyzed whether additional~     immunosuppression on top of standardized supportive care provides renal benefits in patients~     with progressive IgAN. Patients with persisting proteinuria >0.75 g/d (n=162) despite~     optimized supportive treatment including control of blood pressure and proteinuria, were~     randomized to either continue on supportive care or to receive additional immunosuppression~     during the 3-year trial phase. It was observed that immunosuppressive therapy in addition to~     optimized supportive care led to more full clinical remissions, but eventually did not better~     preserve renal function, did not better save patients from ESRD development and evoked more~     adverse effects such as infections, weight gain and diabetes.~      Aim of this planned study is to analyze renal outcome measures and adverse effects in the~     longterm observation of all randomized STOP-IgAN participants to ascertain quality and~     strength of the original trial results. By its observational nature, this quality control~     study includes the 162 IgAN patients (with the exception of drop-out patients) that had been~     previously randomized into the original STOP-IgAN trial.~      Information on serum creatinine, proteinuria, ESRD, death, relevant adverse events such as~     major cardiovascular events, osteoporosis, osteonecrosis, bone fractures, diabetes,~     malignancies and interim treatment will be collected as available from existing routine~     records until March 31, 2018.~      Primary endpoint is the time to the first occurring event of the binary composite of~     all-cause death, ESRD or decline in estimated glomerular filtration rate (eGFR) by at least~     40% as compared to enrollment into the original trial. Secondary outcome measures comprise~     the individual components of the primary endpoint, absolute eGFR at the end of observation,~     proteinuria and adverse events. Information on specific treatments with~     renin-angiotensin-system (RAS)-blocking agents and/or interim immunosuppression will also be~     collected. All data will be recorded in a pseudonymous fashion in a central electronic data~     base located at the PI's site.~   "
5998|NCT03488355|"~     Positive urine cultures collected from indwelling catheters from inpatients will be~     randomized to standard reporting or modified reporting. Physician antibiotic treatment~     decisions will be prospectively observed and determined to be appropriate or inappropriate.~     The hypothesis is that modified reporting will lead to an increase in the percentage of~     appropriate therapy without an increase in pyelonephritis or sepsis.~   "
5999|NCT03488342|"~     Lichtenstein technique, inserting a mesh over the inguinal cord in the neurological plane, is~     considered the standard of inguinal hernia repair, but it has 4% recurrence and 12% chronic~     postoperative pain. Rives technique inserts the mesh in the preperitoneal space behind the~     neurological plane and the muscular plane, thus better fulfilling the principle of~     hydrostatics.~   "
6000|NCT03488329|"~     The study is a randomized controlled study, ongoing over 16 weeks. At discharge, the~     intervention group receives guidance from a clinical dietician, where an individual nutrition~     plan is made. The dietitian will perform a telephone follow-up after 4 and 30 days. It will~     also be possible for the participant, relatives or municipality to contact the dietician if~     nutritional questions arise.~      At the time of discharge the intervention group will receive a package containing foods and~     drinks that will cover their nutritional needs the first day after discharge.~      They will also get a goodiebag containing samples on protein-rich milk-based drinks. Data is~     collected on quality of life, appetite, physical function, dietary intake, weight, height,~     energy and protein needs, as well as experience of discharge and cooperation with the~     municipality.~      If there is a need, information about nutrition status will be sent to the municipality so~     the municipality can take over nutritional treatment.~      The control group receives standard treatment.~   "
6001|NCT03488316|"~     The aim of this study is through a randomized clinical trial, double blind, splitmouth,~     evaluate the success rate (contamination rate, periapical lesion relapse and the presence of~     exudate between the treatment's sessions) of endodontically treated teeth that required~     filling with temporary material. The composition of the temporary filling material (cement~     (Based on calcium hydroxide; and based on mineral trioxide aggregate) will be evaluated. Data~     will be collected, tabulated and submitted to statistical analysis.~   "
8919|NCT03450109|"~     A phase I, randomized, open-label and active-control study to assess the PK, PD and safety~     profiles of LY01005 versus goserelin comparator to be conducted in the USA.~   "
6004|NCT03488277|"~     Prospective trial including full term parturients scheduled for a cesarean section under~     spinal anesthesia. patients are being randomly assigned into 2 groups:~      LE group: will be positioned in 15° left tilt with leg elevation with a 30cm height pillow~     under the heels, this position will be hold after spinal anesthesia until fetal extraction.~      Control group: will be positioned in supine with 15° left tilt. the 2 groups will receive a~     10ml/kg of crystalloid co-load intravenously, and the spinal anesthesia will be performed in~     sitting position with the same dose of Bupivacain, morphine and sufentanil.~   "
6005|NCT03488264|"~     Many individuals with sickle cell disease experience both a poor quality of life and stigma.~     Individuals with SCD often experience high levels of stigma which can be a barrier to good~     self-management and hinder quality of life. The purpose of this research is to improve~     understanding of the relationships between stigma, self-management, and quality of life in~     SCD in the United States and Jamaica. The findings from this project will contribute to the~     development of a tool to measure self-management strategies and will also guide the~     development of interventions to improve SCD self-management.~   "
6006|NCT03488251|"~     The purpose of this study is to evaluate the safety and tolerability of MT-3724 in~     combination with gemcitabine and oxaliplatin (GEMOX) in subjects with relapsed or refractory~     CD20-positive B-Cell NHL.~   "
6007|NCT03488225|"~     Any time the words you, your, I, or me appear, it is meant to apply to the potential~     participant.~      The goal of this study is to learn if inotuzumab ozogamicin given in combination with~     hyper-CVAD can help to control newly diagnosed B-cell acute lymphocytic leukemia (ALL). The~     safety of this drug combination will also be studied.~      Hyper-CVAD is a drug combination and schedule that is described below under Intensive~     Chemotherapy.~      This is an investigational study. Inotuzumab ozogamicin and hyper-CVAD when given alone are~     FDA approved and commercially available for the treatment of ALL. Combining inotuzumab~     ozogamicin with hyper-CVAD is investigational.~      The study doctor can explain how the study drugs are designed to work.~      Up to 60 participants will be enrolled in this study. All will take part at MD Anderson.~   "
6008|NCT03488212|"~     Behavioral obesity treatment produces clinically significant weight loss; for the greatest~     impact, it should be made available in the primary care setting where it can reach the many~     patients with overweight/obesity. The investigators developed a 3-month automated online~     behavioral weight loss program, Rx Weight Loss (RxWL), and showed that it produces clinically~     significant weight losses among primary care patients. The investigators' early efforts at~     pragmatic implementation of RxWL have been promising, and have shed light on challenges~     associated with implementation, and the need to study longer-term effectiveness. The~     investigators will therefore conduct a pragmatic study to improve the implementation and~     effectiveness of this behavioral obesity intervention delivered in routine and representative~     healthcare settings. The investigators are partnering with the Rhode Island Primary Care~     Physicians Corporation (RIPCPC), a large primary care network of 58 practices with 100~     physicians and 16 nurse care managers. Using the framework for Effectiveness-Implementation~     Hybrid Designs, the investigators will simultaneously target effectiveness and implementation~     to maximize the public health impact of the research. Half of the 16 nurse care managers, and~     the practices they serve, will be randomized to either Basic Implementation (alerts generated~     using the electronic medical record [EMR] to direct eligible patients to RxWL), or to the~     Enhanced Implementation (alerts, clinician skills training to motivate and support weight~     loss, clinician dashboard with reports on patient progress and tools to facilitate patient~     engagement and behavior change). The investigators will test the hypothesis that the Enhanced~     Implementation will increase the proportion of patients directed to, enrolling, and~     completing the weight loss program. Because maintenance of weight loss is a critical problem,~     this project will also involve randomization of 600 patients with overweight/obesity and type~     2 diabetes, hypertension, and/or hypercholesterolemia to the 3 month RxWL intervention~     followed by one of three maintenance conditions: (a) Control- 9 monthly online education~     sessions; (b) Monthly Lessons and Feedback- 9 monthly online video lessons teaching~     self-regulation with automated feedback on the self-monitoring record; (c) Refresher~     Campaigns- 9 monthly on-line video sessions, teaching self-regulation and providing two~     4-week courses with novel strategies and behavioral challenges to improve long-term outcomes.~     The investigators will test the hypothesis that 12-month weight losses are better with~     Refresher Campaigns than Monthly Lessons and Feedback, and both are better than Control.~     Secondary outcomes include changes in weight, CVD risk factors, and medication use over a~     full 24 months. The project is significant and innovative because: it uses an empirically~     validated approach to obesity treatment that is integrated into the primary care setting,~     leveraging existing staff and EMR capabilities; it has a dual focus on improving~     effectiveness and implementation; it has a pragmatic design in partnership with a large~     primary care network that treats a diverse patient population; and it has potential to it~     provides a scalable, sustainable approach that can serve as a model for broader dissemination~     of obesity treatment intervention.~   "
6009|NCT03488199|"~     That the study will be carried out as it has the protocol instructions, respecting the~     applicable regulations for clinical investigations with medical devices and following the~     internationally accepted ethical standards~   "
6010|NCT03488186|"~     The objective of this study was to compare the relative PK-PD of Lansoprazole Capsules and~     Lansoprazole DR Capsules in healthy Chinese volunteers.~   "
6011|NCT03488173|"~     The objective of this study was to compare pharmacokinetic of Lansoprazole Capsules 30 mg~     with Lansoprazole Capsules of Takeda 30 mg in healthy adult human subjects.~   "
6012|NCT03488160|"~     The safety and feasibility of CAR-T cells (CD19.CAR-T) targeted at CD19 in the treatment of~     relapsed / refractory CD19 positive lymphoma were determined, and the proliferation and~     survival time of CD19.CAR-T cells in patients were determined.~   "
6013|NCT03488147|"~     The researchers wish to investigate whether proton pump inhibitors, administered prior to or~     after surgery, can reduce the incidence and/or severity of difficulty swallowing foods and/or~     liquids,following anterior cervical surgery.~   "
6014|NCT03488134|"~     Although thyroid cancers are low-grade endocrine malignancy, most patients usually received~     thyroidectomy with ablative radioactive iodine therapy. Such patients were followed with~     thyroid ultrasonography and serial serum thyroglobulin evaluation. Prior researches indicated~     that one-third well-differentiated thyroid cancers could transform to poorly-differentiated~     patterns, even to be anaplastic thyroid cancer (ATC), a fatal malignancy, and no effective~     therapeutic strategies was noted, including surgical intervention, chemotherapy and~     radiotherapy. The poorly-differentiated or anaplastic change of thyroid cancer cells~     proliferates rapidly and always invades local tissues with distant metastasis. Cellular~     de-differentiation is the most pivotal cause for malignant transformation and invasion.~     De-differentiation usually in papillary thyroid cancer and follicular thyroid cancer, and~     definitely in ATC. Therefore, the investigators try to find the biological markers and~     therapeutic targets via the exosomal expression in urine. On the continuing basis of prior~     ATC cells culture experiments.~      Exosomes are nanovesicles secreted into extracellular environments. Cancer cell-derived~     exosomes could be found in plasma, saliva, urine and other body fluid of patients with~     cancer. The investigators try to analyze the urinary exosomal proteins, including~     thyroglobulin and galectin-3, to find the early prognostic biological markers in urine via~     this prospective study.~      The investigators expected to enroll 150 post-operative patients with papillary, follicular~     or anaplastic thyroid cancer, and collect the urine samples in outpatient clinic per year.~     The investigators will analyze the urine exosomal proteins and probable biological markers,~     including thyroglobulin and galectin-3. The investigators hope to find the prognostic~     biological markers via this prospective study. The investigators further hope to find newly~     therapeutic and follow-up pathway for such patients with well-differentiated or anaplastic~     thyroid cancer.~   "
6015|NCT03488121|"~     Choosing Wisely Canada is a campaign for promoting appropriate use of medical services to~     reduce unnecessary prescribing and unnecessary diagnostic tests. Its success depends on~     physicians' uptake of the campaign's recommendations on appropriate use of health care. This~     study will conduct a cluster-randomized controlled trial to evaluate the effects of two~     low-cost incentives for physicians to promote their uptake of Choosing Wisely recommendations~     in Newfoundland and Labrador (NL). The first incentive involves placing a motivational poster~     in a physician's examination room. These posters will contain motivational messages about the~     important roles that doctors and patients can play in reducing unnecessary care. The second~     incentive involves sending thank-you letters to physicians to recognize their contribution in~     reducing unnecessary care, and thus, 'nudge' them into following recommendations. The study~     will evaluate the effects of the incentives on physicians' prescribing of antibiotics and~     serum ferritin tests. Potential cost savings of implementing the two incentives will also be~     estimated.~   "
6016|NCT03488108|"~     The primary objective of this proposal is to conduct a study that assesses the safety,~     feasibility and efficacy of using PRP to treat this type of hair loss.~   "
6024|NCT03487991|"~     We are evaluating a model where trauma exposure and threatening environments elicit nocturnal~     vigilance and sleep-related fears that compromise the healthy reduction of autonomic arousal~     during sleep which in turn stimulates secretion of atherogenic humoral factors, arterial~     stiffening, and cardiovascular disease risk. We will examine the roles of pre-sleep cognition~     using a questionnaire and real time assessment, and modifiable strategies for coping with~     sleep disruptive cognitions. We will then evaluate the impact of providing personalized~     feedback and recommendations based on study observations on how participants cope with~     potentially sleep disruptive cognitions and sleep efficiency in a randomized trial.~   "
6025|NCT03487978|"~     The purpose of this study is to identify a core fMRI feature that determines migrainous brain~     and plastic fMRI features that changes with longitudinal courses of migraine.~   "
6026|NCT03487965|"~     The study is to assess skin attributes of female subjects following 16 weeks of dietary~     supplement consumption.~   "
6017|NCT03488095|"~     Smokeless tobacco (SLT) is a known risk factor for Oral, Pharyngeal and Esophageal carcinoma.~     Three-quarters global SLT consumption is among the South Asian Population. The habit of SLT~     chewing commences at a very young age which has an underpinning of socio-cultural dimension~     in South Asian population which perhaps due to its more addictive potential, has more~     dependency. Youth also perceives SLT as a part of confectionery, which is socially served in~     South Asian ceremonies. There exists very little or no evidence regarding efficacy of SLT~     cessation interventions in this population. Most of the existing interventions are based in~     western world with little or no cultural sensitivities pertinent to South Asia. In this~     study, a culturally rooted behavior changing intervention (BCI) to alter SLT use prevalence,~     perceptions pertinent to the deleterious effects of SLT use in the etiology of oral cancers~     and help youth quit SLT in Karachi, Pakistan.~      Baseline demography and SLT use prevalence will be ascertained among 11-16-year-old school~     going children from both government and private schools. Multi stage cluster sampling will~     randomly recruit forty clusters (schools) from within 6 districts of Karachi, which will then~     be divided into intervention and control groups (clusters) using block randomization based on~     proportionate number of each school type present (Government and Private).~      Both groups' participants will complete all questionnaires pre and post intervention as~     described elsewhere and will also undergo screening for oral cancer and oral potentially~     malignant lesions (OPMLs). Students in intervention cluster will be given BCI and printed~     pamphlets along with a gift pack (reminder for SLT quit, a branded tooth paste and a tooth~     brush) while students in control cluster will only differ in that they will not be exposed to~     BCI.~      BCI was designed after reviewing literature and consulting specialist group for all untoward~     effects of SLT use in Oral Cavity that have a potential of transforming into oral carcinoma.~      A follow up after 12 weeks will be conducted to re-assess their SLT use prevalence,~     perceptions regarding hazardous effects of SLT use in oral cavity, dependency on SLT and~     success in quit (among users in both groups), and perception regarding warning labels on SLT~     product packet~   "
6018|NCT03488082|"~     Accurate execution of our directed behaviors in the immediate environment allows the vast~     majority of our daily activities. Through the movements of our eyes and different parts of~     our body, we perceive, explore and act on our environment and can exchange and communicate~     with others. The mechanisms of sensorimotor adaptation of saccades (saccadic adaptation)~     contribute on the one hand to maintain the accuracy of saccades in the short, medium and long~     term, by opposing the deleterious effects of various physiological changes (development,~     aging), pathological or environmental (optical corrections).~      The aim of this study is to identify neuronal structures and networks involved in saccadic~     adaptation through the study of brain metabolic activation (BOLD) during the development of~     the adaptation of reactive saccades. The study will be organized in a single session with 3~     runs. Each run include 4 blocks: 3 include the double-step target paradigm RND, U+, U-) and~     one without target jump (STA). The 'U+'/ 'U-'blocks include saccadic trials with~     forward/backward displacement of the target during a targeting saccade, the 'RND' block~     include saccadic trials with random target jump (forward or backward) and the 'STA' block are~     trials without displacement of the target. Each subject will make 12 repetitions of the 4~     blocks.~   "
6019|NCT03488069|"~     Sedation is one of the most common practices applied in intensive care units (ICU) and the~     management of sedation, analgesia and delirium is a quality measure in ICUs. Several~     intensive care societies published guidelines regarding the use of sedatives and analgesics~     recently. In literature there are many survey studies investigating practices of sedation in~     ICUs of different countries, but knowledge of the sedation practices of intensive care~     physicians in Turkey is lacking. The aim of this study was to provide a baseline knowledge on~     this matter and to establish some points to be improved. An electronic survey form,~     consisting of 34 questions was generated with google forms, posted to 1700 email addresses~     and 429 returned (25%). The survey included questions about demographics and choices and~     routines of sedation, analgesia, neuromuscular blockers and delirium administration.~     Ninety-six percent of the respondents indicated that they practiced sedation in their ICUs~     and mechanical ventilation was checked as the primary indication (94%). On the question~     regarding drug choices for sedation, midazolam was the most preferred agent (90%). About pain~     questions, the most used evaluation tool was visual analogue scale (69.0%) and 83% of the~     respondents preferred to use tramadol for pain, followed by paracetamol (81.6%). Of the~     participants, 50.5% indicated that they routinely evaluated delirium and 56% of them used~     confussion assessment method for ICU. The awareness of 2013 American College of Critical Care~     Medicine (ACCM) guideline for the management of pain, agitation, and delirium was only 38%.~     The results of this survey have indicated some areas to be improved, such as low incidence of~     written sedation protocols, frequent use of benzodiazepines, and delirium screening. A~     national guideline should be prepared taking pain, agitation, and delirium in focus.~   "
6020|NCT03488056|"~     The aim of the present study is to evaluate the effectiveness of using the ICCMS~     (International Caries Classification And Management System)in reducing caries lesions~     incidence compared to a control group that use different criteria as a not systematic and~     standardized prevention strategy. The study will be performed among children attending to the~     social project of Social Service of Commerce (SESC), Sao Paulo. The sample will be composed~     of 460 children aging between 7 to 12 years old registered in CURUMIM Program from eight~     dental centers of SESC. A randomized controlled study with parallel group will be conducted.~     The centers will be randomized between the 2 strategies, defining 2 groups with 4 centers~     each. The experimental group that will follow the criteria defined by the ICCMS will evaluate~     clinical and behavioral variables, it will define: evaluation of the caries risk of the~     patient, evaluation of the intraoral risk, diagnosis of the caries lesion and its respective~     activity, plan decision individualized treatment for the patient and indication of recall~     interval according to the risk of caries. In the control group, children need will be solved~     according to rthe routinely dental practices in the center, but the determination of the~     child's general and intraoral risk of developing new caries lesions will not be performed nor~     the scheduling of specific recall intervals according to the risk.~   "
6021|NCT03488043|"~     Transthoracic lung biopsy (TLB) provides a histological diagnosis of nodule or lung mass.~     Pneumothorax is the main complication of TLB with an average of 20%. Many risk factors,~     whether clinical, computed tomography or related to TLB, are described in the literature. The~     British Thoracic Society recommends monitoring for 2 hours after the procedure with a~     possible discharge if the chest X-ray is normal. There is no French or European~     recommendation for monitoring the occurrence of pneumothorax after TLB. In the university~     center of Besançon, France, a minimum supervision of 4 hours is recommended and approximately~     one in two patients is hospitalized until the following day to reach this minimum time of 4~     hours. The objective of the SPOT study is to perform a predictive score of pneumothorax from~     a retrospective cohort of patients for whom a transthoracic lung biopsy was performed and to~     validate this score on a prospective cohort. The expected goal is to select patients who can~     benefit from outpatient care by shortening the post-procedure surveillance period and to~     monitor more long-term only high-risk patients.~   "
6022|NCT03488030|"~     The purpose of this study is to evaluate the percentage of moderate to severe IBD~     participants with active disease at Day 1.~   "
6023|NCT03488017|"~     The Ocular Coil is intended to provide drug delivery to the ocular surface. This study will~     evaluate the safety and tolerability of the placebo Ocular Coil in healthy subjects.~   "
28643|NCT03192085|"~     This study will compare SITA-Standard and SITA-Fast tests in patients newly referred to the~     glaucoma screening clinic at the RD&E hospital.~   "
6027|NCT03487952|"~     Lung cancer is one of the leading cause of cancer related death in China. Lung cancer~     screening with low-dose computed tomography was considered as a better approach than~     radiography. However, the role of Lung cancer screening with Low-dose CT (LDCT) among Chinese~     people remains unclear. With rapid development of artificial intelligence (AI),the~     application of AI in detection and diagnosis of diseases has become research focus. Moreover,~     patients' psychological status also plays an important role in diagnosis and treatment.~      This study focuses on detection and natural history management of lung nodule and lung cancer~     with AI assisted chest CT among people living in North China, and aims to investigate~     epidemiological results, patients' medical records and social psychological status.~   "
6028|NCT03487939|"~     To evaluate the efficacy and safety of neoadjuvant FOLFOXIRI chemotherapy (irinotecan,~     oxaliplatin and fluorouracil) in the patients with resectable liver metastasis of colorectal~     cancer~   "
6029|NCT03487926|"~     The purpose of this study is to monitor microglial activation in participants with~     inflammatory bowel disease (IBD) and investigate the relationship that exists between these~     patients and their risk of acquiring major depressive episodes (MDE). Patients with both IBD~     and MDE will be subsequently approached to participate in the study.~   "
6030|NCT03487913|"~     This is a Phase 2, open-label, parallel-group, multiple dose study designed to evaluate the~     pharmacokinetics, pharmacodynamics, safety and tolerability of multiple doses of lixivaptan~     in Autosomal Dominant Polycystic Kidney Disease subjects with chronic kidney disease in~     stages CKD1, CKD2 or CKD3.~   "
6031|NCT03487900|"~     The CREDO 2 study follows CREDO 1 study, which aims to construct an objective evaluation of~     endoscopic remission in Crohn's Disease (CD). In addition to reproducibility and validation,~     the predictive value of this remission evaluation needs to be tested in different settings to~     valorise its usefulness in clinical practice and in clinical trials.~      CREDO 2 aims to investigate whether the evaluation of endoscopic remission, as defined in~     CREDO 1, in patients in clinical remission is predictive of sustained clinical remission at 2~     years.~      The design of CREDO2 is a multicentre longitudinal prospective cohort study. The screening~     period to include a patient is two weeks. Patients will be followed up to week 104.~   "
6032|NCT03487887|"~     Introduction and objective: The current state of glucose monitoring includes the use of A1C,~     self-monitoring of blood glucose (SMBG), and continuous glucose monitoring (CGM). CGM~     technology has got the potential to revolutionize diabetes care in the near future striving~     to optimal diabetes management and tight glucose control. Until very recently, this~     determination could only be achieved by the attainment of multiple capillary blood glucose~     determinations each day and/or measuring hemoglobin A1C. Those methods are not accurate in~     cases of unrecognized hypoglycemia, unrecognized nighttime events or in cases of large swings~     in blood glucose. Our aim is to analyze the benefit of tracking patterns of glucose values by~     using professional CGM technology used for blinded collection of glucose data~     retrospectively in patients with T2DM in secondary care- diabetologist clinic.~   "
6033|NCT03487874|"~     This study evaluates the effects of selective 8th cervical nerve root block during~     interscalene brachial plexus block on the relief of pain intensity upon the introduction of a~     posterior portal during arthroscopic shoulder surgery. The 5th to 7th cervical nerve roots~     will be blocked in half of participants, while the 5th to 8th cervical nerve roots will be~     blocked in the other half.~   "
6034|NCT03487861|"~     The aim of this study is to verify the ability of transglutaminase type 2 to predict~     rejection or chronic allograft nephropathy of renal allograft. On the basis of biomolecular~     mechanisms aggravating chronic allograft nephropathy, we eventually expect to develop the~     remedy to prevent chronic allograft nephropathy after kidney transplantation.~   "
6035|NCT03487848|"~     The purpose of this study is to evaluate daclatasvir in combination with sofosbuvir given to~     children with chronic hepatitis C infection~   "
6036|NCT03487835|"~     Aim: The present study aimed to investigate the role of Kinesiology ('Kinesio') tape in the~     physiological risk of falling in older adults.~      Methods: Twenty two older adults aged over 65 years and living in nursing homes. After~     assessment of demographic information, they were randomized into one of two groups [(Kinesio~     tape (n = 22) and control (n = 20)]. Kinesio tape was applied on the Kinesio tape group only~     and worn during a 2-week intervention period. Participants were evaluated with the Visual~     Analog Scale, Berg Balance Scale, Timed Up and Go Test, Mini-Mental State Examination,~     30-Second Sit to Stand test and Functional Independent Measurement instrument at baseline,~     after 2 weeks of application and at 2-week follow-up.~   "
6037|NCT03487822|"~     This study examines the effects of PATH-Pain on emotion regulation to improve self-management~     of pain and pain-related disability in older adults with chronic pain, negative emotions, and~     cognitive impairment. Half the participants will receive the intervention, and half the~     participants will receive usual care with education. Intervention subjects are hypothesized~     to have significantly less pain-related disability versus usual care subjects after 24 weeks.~   "
6038|NCT03487809|"~     Inhaled corticosteroid (ICS) is considered the first line medication for asthma, however, the~     therapeutic effect is markedly different even in patients with almost similar clinical~     manifestations. Our study was designed to explore the clinical and genetic factors that may~     influence the effectiveness of ICS in asthmatic children.~   "
6039|NCT03487796|"~     This study will develop and test the efficacy of an online, family-based intervention~     (MySTYLE) tailored to the relevant sexual health needs of non-heterosexual adolescent males~     and their parents/caregivers compared to an online family-based intervention that addresses~     general health topics. Adolescent males and their parents will be recruited from community~     organizations, medical clinics and schools in Jackson, MS. Interviews with youth, parents,~     and relevant community leaders will inform the development of the interventions. Youth and~     their parents/caregivers in both interventions will complete three assessments in the six~     months after enrolling. This study will provide a wealth of information about the degree to~     which this intervention may be disseminated for this highly vulnerable population of young~     people.~   "
6193|NCT03485794|"~     This pilot research trial utilizes the collection of blood in studying metabolites in~     patients with prostate cancer. Metabolites are the small molecule products of cellular~     metabolism that are produced naturally in all living cells. Collecting blood in order to~     study metabolites may help doctors monitor and treat prostate cancer more effectively.~   "
6040|NCT03487783|"~     This study is a multicenter, randomized, double-blind, placebo-controlled trial designed to~     assess the safety, efficacy, tolerability and steady-state plasma trough concentration of~     flexible-dosed aripiprazole once-daily administration in children and adolescents with~     Tourette's syndrome. A total of around 120 subjects will be randomized to aripiprazole (2~20~     mg) or placebo in a 1:1 ratio (approximately 60 subjects in each group), for treatment of 8~     weeks.~   "
6041|NCT03487770|"~     This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to~     assess the efficacy, safety, tolerability and the steady-state plasma trough concentration of~     aripiprazole flexible-dosed in children and adolescents with a diagnosis of Autistic~     Disorder. Approximately 100 subjects will be randomly assigned at a 1:1 ratio to receive~     aripiprazole (2 to 15 mg) or placebo treatment for 8 weeks~   "
6042|NCT03487757|"~     In this study the investigators will examine the effects of core stabilization exercises on~     respiratory muscle strength, respiratory functions and postural control in hearing-impaired~     children.~   "
6043|NCT03487744|"~     The purpose and primary objective of this study is to determine if there is an association~     between enteral tube feed (TF) osmolality and diarrhea in critically ill patients. The~     investigators hypothesize that the administration of a TF formulation with high osmolality~     will cause more diarrhea than a TF formulation with a lower osmolality.~   "
6044|NCT03487731|"~     The study is a phase I/II trial where allogeneic human mesenchymal stem cells (hMSCs) are~     injected intracfect into the lumbar facet joints. Forty (40) subjects are scheduled to~     undergo injection after meeting all inclusion/exclusion criteria will be evaluate at~     baseline.~   "
6045|NCT03487718|"~     This 14 weeks longitudinal study will be conducted from March 2018 to June 2020, with a 40~     participants. No subjects will receive placebo medication at any point in the research~     procedures.~      The proposed sample population will be recruited from the patient population of the~     University of Kentucky College of Dentistry clinics and the patient must have an~     unsalvageable tooth that is planned for extraction and delayed implant placement and will be~     assigned into a control group and a test group by chance. Twenty extraction socket sites of~     the test group will be filled with autogenous L-PRF Plug (Intralock) and d-PTFE membrane~     (Cytoplast) will be laid on the top to seal the extraction socket. In the control group,~     d-PTFE membrane (Cytoplast) will be laid on the top of twenty extraction sockets to allow~     natural blood clot formation in the extraction socket.~      The primary aim is to assess the quality of the newly formed bone at 14 weeks the time of~     implant placement by comparing the percentage of new vital bone in the histomorphometric~     analysis. The second aim is to assess the primary stability of the implant using the~     resonance frequency analysis (RFA) and insertional torque (IT) of the implant. The third aim~     is to assess the horizontal and vertical changes of the residual bony ridge using Cone Bean~     Computerized Tomography (CBCT) analysis at baseline immediately after tooth extraction at 12~     weeks of healing. The fourth aim is to assess the soft tissue healing with a series of~     intraoral occlusal photographs.~      Null hypothesis: The use of L-PRF plug, in combination with non-resorbable, open barrier~     membrane technique to fill the extraction sockets will have no effect on the quality of the~     newly formed bone nor on the dimensional changes of the ridge, compared to non-resorbable,~     open barrier membrane technique with natural blood clot.~   "
6046|NCT03487705|"~     Essential tremor (TE) is the most common abnormal movement of the adult. His diagnosis is~     based on a bundle of clinical arguments (Movement Disorders Society, 1998). Well~     characterized in the adult, little data is available concerning child. The objective of this~     work is (1) to define the demographic and clinical characteristics of the TE of children and~     adolescents, (2) to determine the electrophysiological characteristics in the child, (3)~     evaluate the functional impact of TE, and assess the functional impact of TE, and assess the~     current management modalities of TE in children and adolescent.~   "
6047|NCT03487692|"~     Diabetes group visits, shared appointments where patients receive self-management education~     in a group setting and have a medical visit, are a promising way to deliver high quality~     diabetes care. Group visits can improve glycemic control and decrease healthcare utilization.~     To date, no studies have systematically implemented a diabetes group visit intervention in a~     network of U.S. community health centers. The University of Chicago is partnering with~     Midwest Clinicians' Network (MWCN), a member organization of 130 health centers across ten~     Midwestern states. Approximately half of all Federally Qualified Health Centers in this~     region are affiliated with MWCN. The objectives of the study are [1] providers and staff at~     20 health centers will have the requisite knowledge, skills, and motivation to implement a~     diabetes group visit plus text messaging intervention at their sites; [2] changes in diabetes~     processes of care; knowledge, attitudes, and skills for diabetes self-management; clinical~     outcomes; and health care utilization for patients participating in the diabetes group visit~     program will be evaluated; and [3] the diabetes group visit program will be available for~     dissemination among and use by health centers and healthcare providers at the local, state,~     regional, and national levels.~   "
6048|NCT03487679|"~     Participants will undergo one day of habitual eating followed by 36 hours of water only~     fasting and final day of habitual eating of the exact same diet consumed on the first eating~     day. Blood draws will be performed on Day 1 in a 10-12 hr fasted state and 2 hour~     postprandial state and again on Day 3 in a 36hr fasted state and a 2 hour post prandial~     state. Microbiome samples and blood glucose data will be collected throughout the course of~     the study.~   "
6049|NCT03487666|"~     This pilot study will provide preliminary data regarding the role of PIS in predicting the~     benefit of immune checkpoint inhibition with or without chemotherapy for high risk patients~     with TNBC and residual disease after effective neoadjuvant chemotherapy.~   "
6060|NCT03487523|"~     The objective of this research is to investigate whether a text message (SMS message)~     prompting participation in the UK national bowel cancer screening programme improves uptake~     for those who have not responded to the test.~      The secondary objective is to investigate whether the framing/phrasing of the text message~     improves participation , whether by stating the benefits of uptake or alternatively by~     stating the costs of non-uptake.~   "
6061|NCT03487510|"~     Recording of routine practice patterns to detect and/or treat Dysphagia on the ICU via~     interview of local colleagues. This will not allow to record generalizable data, but will~     reflect the actual routine standard of care.~   "
6078|NCT03487289|"~     Laparoscopic right hemicolectomy (LRH) is an accepted surgical procedure for several right~     sided colonic pathologies. Recently the advantages of the intracorporeal ileotransversostomy~     over the extracorporeal anastomosis is appearing in the literature. Additionally, specimen~     extraction through the natural orifices is an emerging method when combined with the totally~     laparoscopic procedures. Our observations on natural orifice surgery was promising . In our~     daily surgical practice, investigators prefer the intracorporeal anastomosis and this study~     was conducted to compare the specimen extraction sites after LRH. Here investigators aimed to~     compare the results of conventional and natural orifice specimen extractions (NOSE) after~     totally LRHs.~   "
6050|NCT03487653|"~     Indocarditis is an endogenous infection acquired when organisms entering the blood~      stream establish on the heart valves, therefore, any bacteremia can potentially result in~     endocarditis.~      Infective endocarditis is an uncommon disease that often presents as pyrexia of unknown~     origin.~      The mortality rate in endocarditis was very high before the antibiotic era, even now a day,~     the~      mortality rate is around 20%(1).A variety of microorganisms can cause IE; staphylococci and~     streptococci account for the majority of cases. Staphylococcal IE is a common cause of~     healthcare-associated IE ; streptococcal IE is a common cause of community-acquired IE.~     Common bacterial pathogens include Staphylococcus aureus , Viridans group streptococci ,~     Enterococcus, Coagulase-negative staphylococci , Streptococcus bovis , other streptococci ,~     gram-negative bacteria, HACEK organisms in this category include a number of fastidious~     gram-negative bacilli: Haemophilus aphrophilus(subsequently called Aggregatibacter~     aphrophilus and Aggregatibacter paraphrophilus); Actinobacillus actinomycetemcomitans~     (subsequently called Aggregatibacter actinomycetemcomitans); Cardiobacterium hominis;~     Eikenella corrodens; and Kingella kingae , and fungi (1,2). A variable proportion of IE~     remain blood culture- negative (1-4). Most clinically significant bacteremias are detected~     within 48 hours; common and fastidious pathogens (such as members of the HACEK group) may be~     detected within five days of incubation with modern automated blood culture detection~     systems. The optimal volume of blood for each blood culture in adults is 20 ml.~      Zoonotic agents, such as Coxiella burnetii, Brucella spp., and Bartonella spp. were~     frequently detected in North Africa and identified as causes of infective endocarditis (IE)~     in Egypt (3,4).Blood culture is the most important investigation for diagnosing infective~     endocarditis~      andto know the prevalence rate of different bacteria and their antibiotic sensitivity~     pattern.Positive blood culture is the cornerstone of microbiological diagnosis of IE; three~     sets of blood cultures detect 96 to 98 percent of bacteremia. At least three sets of blood~     cultures should be obtained from separate venipuncture sites prior to initiation of~     antibiotic therapy. Patients with IE typically have continuous bacteremia; therefore, blood~     cultures may be collected at any time and need not necessarily be obtained at the time of~     fever or chills.~      MATERIAL and METHOD A total of 150 blood cultures were received from 50 clinically diagnosed~     cases of bacterial endocarditis .~      Blood sample was collected under all aseptic precautions.~   "
6051|NCT03487640|"~     Chronic obstinate constipation is hard to deal with in clinic. Especially for obstructed~     defecation syndrome(ODS). Rectal prolapse is the most common type of ODS. Lots of surgical~     procedures have been suggested for it but with unsatisfactory results.To develop new surgical~     treatment and to provide higher quality proof for this intractable condition is of~     significance.~   "
6052|NCT03487627|"~     Adolescents who have been hospitalized after attempting suicide are at risk for engaging in~     additional suicidal behavior. After hospitalization, parents or guardians are typically asked~     to be responsible for helping to prevent further suicidal behavior. This can include~     monitoring the youth, making sure the home is safe, getting the youth any needed treatment,~     and balancing the parents' expectations of the youth with the understanding that the youth is~     in a vulnerable state. Even with this effort by parents, adolescents often have additional~     crisis situations. The goal of this study is to develop and test an integrated electronic~     (mHealth) and care support service intervention for these caregivers of suicidal youth. It is~     expected that this intervention will help parents/guardians in the roles of caring for~     suicidal youth after discharge from the hospital. This pilot randomized controlled trial will~     compare the intervention to enhanced treatment as usual.~   "
6053|NCT03487614|"~     Primary care offers a promising setting for promoting parenting practices that shape healthy~     eating and physical activity behaviors of young children. This study assessed the impact of a~     parent-based, primary care intervention on the feeding habits, health behaviors, and body~     mass index (BMI) of 2-5 year olds with elevated or rapidly-increasing BMI. Four private~     pediatric offices in West Michigan were assigned as control (n=2) or intervention (n=2) sites~     based on patient load and demographics. Treatment families were recruited at well-child~     visits to receive physician health-behavior counseling and four visits with a registered~     dietitian nutritionist (RDN) over a 6-month period. Outcomes included percent of the 95th BMI~     percentile (%BMI95), the Family Nutrition and Physical Activity survey (FNPA), and the~     Feeding Practices and Structure Questionnaire (FPSQ).~   "
6054|NCT03487601|"~     This research is being done to determine whether transcranial direct current stimulation~     (tDCS) can improve fatigue and certain thinking skills in women with breast cancer receiving~     chemotherapy.~      Transcranial Direct Current Stimulation is a form of brain stimulation during which low~     amounts of electrical current are delivered to the brain using electrodes attached to the~     scalp. The idea of using electrical stimulation to affect neurological symptoms has been~     around for more than 100 years with the first reported use in 1801. Since the 1960s, tDCS has~     been used in research for a variety of reasons including stroke rehabilitation, memory~     enhancement and for depression.~      People aged 18 or older who are currently receiving chemotherapy with docetaxel and who are~     experiencing fatigue may join.~   "
6055|NCT03487588|"~     This study is an open-label study designed to evaluate subject's satisfaction after treatment~     of seborrheic keratoses with A-101 40%.~   "
6056|NCT03487575|"~     Adolescents who have been hospitalized after attempting suicide are at risk for engaging in~     additional suicidal behavior. After hospitalization, parents or guardians are typically asked~     to be responsible for helping to prevent further suicidal behavior. This can include~     monitoring the youth, making sure the home is safe, getting the youth any needed treatment,~     and balancing the parents' expectations of the youth with the understanding that the youth is~     in a vulnerable state. Even with these efforts by parents, adolescents often have additional~     crisis situations. The goal of this study is to develop and test an integrated electronic~     (mHealth) and care support service intervention for caregivers of suicidal youth. It is~     expected that this intervention will help parents/guardians in the roles of caring for~     suicidal youth after discharge from the hospital. This open trial will assess the feasibility~     of this intervention for a separate pilot randomized controlled trial to compare the~     intervention to enhanced treatment as usual.~   "
6057|NCT03487562|"~     This is a randomized, open-label, multiple dose, two-part phase I clinical trial to compare~     the pharmacokinetics, pharmacodynamics and safety/tolerability of DWP14012 after~     administrations of DWP14012 alone and combinations of DWP14012, Clarithromycin and~     Amoxicillin in healthy male subjects~   "
6058|NCT03487549|"~     This is a Phase 2, open label study to evaluate the efficacy, safety and tolerability of~     VP-102 in subjects (2 years and older) with common warts. Subjects will be enrolled in the~     study until 20 subjects have completed the EOS visit.~   "
6059|NCT03487536|"~     Background. Several nutritional factors have been evaluated as prognostic factors for~     survival in ALS patients at earlier stages of the disease [body mass index (BMI), body~     composition expressed as fat free mass (FFM), fat mass (FM), phase angle (PhA), low-density~     lipoprotein/high-density lipoprotein (LDL/HDL) ratio, cholesterol levels], while only two~     studies have evaluated some of these parameters after PEG placement.~      Aim. BMI and cholesterol levels were evaluated as prognostic factors for survival after~     percutaneous endoscopic gastrostomy (PEG) placement Moreover, the relationship between body~     composition and BMI in a subgroup of ALS patients was evaluated.~   "
6062|NCT03487497|"~     A common surgical treatment for posterior tibial tendon dysfunction (and the resulting flat~     foot) is the correction through a calcaneal lengthening osteotomy of the lateral column~     (LLC). Clinical studies showed pain relief and functional improvements through different~     scores. However, according to clinical experience, some patients complain about a limited~     ankle dorsiflexion after LLC surgery. Several joints of the foot (talocrural, subtalar,~     talonavicular, calcaneocuboid) contribute to the overall range of motion in foot~     plantarflexion/dorsiflexion and pronation/supination. Changes in the range of motion in one~     joint can affect all the other joints. For instance, it was shown that a fusion of the~     talonavicular joint removes most of the residual hindfoot motion in~     plantarflexion/dorsiflexion and pronation/supination. Because the lengthening of the lateral~     column presumably decreases the mobility of the medial column and thus of the talonavicular~     joint, this surgery can influence the range of motion of the other joints, and hence~     contribute to the reported decreased ankle dorsiflexion motion.~      Patients after LLC have less plantarflexion of the first metatarsal throughout stance of~     level walking and less inversion of the hindfoot during push-off compared to healthy~     subjects. Uphill walking requires more ankle plantarflexion and dorsiflexion than level~     walking. A limitation of the ankle joint mobility especially in dorsiflexion could therefore~     lead to additional or greater changes in gait patterns (hindfoot and forefoot kinematics)~     during uphill walking.~      The primary objective is:~      • To compare differences in hindfoot and forefoot kinematics between level and uphill~     treadmill walking in relation to passive range of motion~      The secondary objectives are:~        -  To compare lower leg muscle activation during level and uphill treadmill walking between~          patients after LLC and healthy subjects~        -  To test the association between muscle strength, muscle activation patterns and hindfoot~          and forefoot kinematics during level and uphill walking and heel rise~        -  To relate clinical outcome of LLC surgery by functional scores to passive range of~          motion~   "
6063|NCT03487484|"~     The goal is to evaluate whether the renunciation of a diverting stoma in patients with~     adjuvant chemotherapy after low anterior resection with total mesorectal excision (TME) and~     neoadjuvant chemoradiotherapy leads to a better quality of life without increasing morbidity~     and mortality in patients with rectal cancer.~   "
6064|NCT03487471|"~     Tissue elasticity is being increasingly used as diagnostic parameter, since at the~     macroscopic level benign breast lesions tend to be stiffer than normal breast tissue but~     softer than breast cancers. Ultrasound elastography allows to probe the elasticity of breast~     lesions in clinics. Real time elastography (RTE) and shear wave elastography (SWE) are the~     two most widely used elastography modalities.~      Assessment of breast lesions by either RTE or SWE improve the diagnostic performance of~     standard B-mode ultrasound (US) and have the potential to assist the decision about whether~     to perform a breast biopsy or not.~   "
6065|NCT03487458|"~     This study is a prospective study. Patients with traumatic rib fractures are divided into~     control group and surgical (OP) group, depending on whether they undergo rib fracture~     fixation surgeries. They complete Short Form-36 and Work Quality Index (WQI) before surgery~     and after surgery (before discharge, post-surgery 1 month, 3 months and 6 months). The goal~     of this study is to examine the life quality of patients who receive surgical treatment for~     rib fracture by analyzing patients' response, comorbidity, vital signs (blood pressure, heart~     rate, respiratory rate, Glasgow Coma Scale (GCS) etc.), severity of fracture (AIS, ISS) and~     medical costs. The investigators hope to find the most suitable method of treatment for~     patients with rib fractures.~   "
6066|NCT03487445|"~     The goal of this study is to find out how fast a drug called ACT-246475 can prevent platelets~     from binding together. This study will also help to find out more about the safety of this~     new drug. The drug ACT-246475 will be used in 2 different doses (8 mg or 16 mg) and will be~     administered in the thigh.~   "
6067|NCT03487432|"~     The objective of this prospective, multicenter, randomized, open-label trial is to evaluate~     the completeness of stent expansion following a strategy of lesion preparation with either a~     Super High-Pressure NC PTCA Balloon (OPN NC) or a Scoring PTCA Balloon (NSE Alpha) after~     unsuccessful lesion preparation with conventional NC balloon angioplasty in an~     angiographically well-defined group of patients with severely calcified coronary lesions~     (grade 3) undergoing coronary stent implantation (SYNERGY everolimus-eluting stent (EES)).~   "
6068|NCT03487419|"~     The aim of this study to investigate the correlation between preoperative LA function using~     2D echocardiography and left atrium 2D speckle tracking strain echocardiography and the~     development of Post Operative AF after CABG.~      the investigators chose electrocardiography as a reference standard for detection of Post~     Operative AF. LA dysfunction is diagnosed with Echocardiography~   "
6069|NCT03487406|"~     Patients with COPD (chronic bronchitis and/or emphysema) are known to be at an increased risk~     of heart disease and death due to heart attacks. There are several possible reasons for this,~     one of which is an increased tendency of the blood to clot, that can give rise to blood clot~     formation in the coronary arteries, and lead to heart attack. Medications such as Aspirin and~     another new blood thinning tablet called Ticagrelor are already used for patients with heart~     attacks. Given that patients with COPD are at higher risk of heart attack, the investigators~     wish to see if these tablets that can prevent blood clot formation in heart arteries might~     also prevent heart attacks happening in COPD patients. The investigators hope to understand~     the effects by measuring clotting and inflammation in the blood. All patients will be~     followed up for 6-months.~      In addition the investigators wish to study COPD patients who do not have a high risk of~     developing future heart problems using the QRISK score to study their well being over a 1~     year period to see if they might also benefit from blood thinning medications.~   "
6070|NCT03487393|"~     Find the stimulation threshold of the facial nerve (ganglion Geniculate) associated with~     tolerability and safety in subjects Healthy humans.~   "
6071|NCT03487380|"~     The objective of the study is to highlight a modification of the composition of the~     intestinal microbiota associated with the diagnosis of Alzheimer's disease and its most~     unfavorable form, Rapid Cognitive Decline (DCR). This identification could lead to diagnostic~     strategies based on the analysis of the intestinal microbiome, and preventive and curative~     treatments, based on the modulation of intestinal microbiota~   "
6072|NCT03487367|"~     The investigators plan to fill the gap between the current state of clinical trial readiness~     and the optimal one for SCA1 and SCA3, which are fatal rare diseases with no treatments.~     Through US-European collaborations, the investigators will establish the world's largest~     cohorts of subjects at the earliest disease stages, who will benefit most from treatments,~     validate an ability to detect disease onset and early progression by imaging markers, even~     prior to ataxia onset, and identify clinical trial designs that will generate the most~     conclusive results on treatment efficacy with small populations of patients.~   "
6073|NCT03487354|"~     Medical abortion using multiple vs single daily dose of misoprostol in first trimester~     miscarriage.~   "
6074|NCT03487341|"~     Placental Cord Drainage after Vaginal Delivery A randomized clinical trial~   "
6075|NCT03487328|"~     This prospective interventional randomized controlled trial is conducted to compare a new~     technique for Sacrospinous-Sacrotuberous fixation with the traditional sacrospinous ligament~     fixation technique for treatment of uterovaginal and vaginal vault prolapse.~   "
6080|NCT03487263|"~     Ten patients with motor neurone disease (MND, also known as amyotrophic lateral sclerosis or~     ALS) will be successively enrolled to one of two dose levels of IC14 (human chimeric~     monoclonal anti-CD14) intravenously for four doses. Patients must be within 3 years of MND~     diagnosis and have adequate respiratory function. Safety, tolerability, immunogenicity, and~     PK/PD will be measured. To evaluate feasibility of the endpoints, additional endpoints of~     ALSFRS-R, respiratory function tests, disease biomarkers and patient-reported outcomes will~     be measured.~   "
6081|NCT03487250|"~     To evaluate the acute and long-term clinical outcomes of tenotomy with the TenJet System in~     patients with elbow tendinosis.~   "
6082|NCT03487237|"~     Syncope is a rapid onset, transient, loss of consciousness with a short duration. This~     symptom has been reported to be a specific presentation of patients with pulmonary embolism.~     However, the prevalence of pulmonary embolism in patients with syncope remains debated. This~     prospective cohort study will recruit patients presenting to the emergency department with a~     syncope, who will systematically undergo formal workup for pulmonary embolism. The main~     objective of this study is to assess the prevalence of pulmonary embolism in ED patients with~     syncope~   "
6083|NCT03487224|"~     The purpose of this study is to understand the neural mechanisms of decision making in~     hoarding disorder.~   "
6084|NCT03487211|"~     Duloxetine is FDA approved as pharmacological treatment for Fibromyalgia. The use of SSRIs~     has been endorsed by the 2013 Canadian guidelines. The data available for Escitalopram as a~     treatment modality for Fibromyalgia is limited, however small trials have demonstrated its~     efficacy. No head to head comparisons between escitalopram and duloxetine have been~     undertaken. We aim to conduct a single blind, randomized control trial to assess the~     comparative efficacy of duloxetine vs escitalopram in drug naive patients with newly~     diagnosed Fibromyalgia.~   "
6085|NCT03487198|"~     This study is a multicenter, randomized, double-blind, placebo-controlled trial designed to~     assess the efficacy and safety of brexpiprazole as adjunctive therapy in the treatment of~     Major Depressive Disorder. A total of approximately 1100 subjects will be enrolled into the~     single-blind treatment for 6 weeks, and 480 incomplete responders will be randomized to~     brexpiprazole (2~3 mg) or placebo in a 1:1 ratio (approximately 240 subjects in each group),~     for treatment of 6 weeks.~   "
6086|NCT03487185|"~     A randomized controlled trial of 2,700 women to assess whether treatment of obstructive sleep~     apnea with continuous positive airway pressure (CPAP) in pregnancy will result in a reduction~     in the rate of hypertensive disorders of pregnancy.~   "
6087|NCT03487172|"~     All subjects will receive three, single-sided injections of PLLA, performed 1 month apart.~   "
6088|NCT03487159|"~     This study evaluates the ability of Magnetic Resonance Elastography non invasive technology~     to identify the liver fibrosis stage in patients with chronic liver diseases compared to~     Shear Wave Elastography and/or Liver Biopsy.~   "
6089|NCT03487146|"~     Sleep disturbance has been long-standing torments in most of patients with maintenance~     hemodialysis (HD). In this study, we attempted to explore whether long-term hemoperfusion~     (HP) could improve sleep disorder and increase overall survival rate in HD patients.~   "
6090|NCT03487133|"~     the efficacy and safety of bortezomib / dexamethasone combination therapy in patients with~     relapsed or refractory T-cell lymphoma who have failed one or more treatments.~        -  primary purpose~           1. Overall response rate~        -  secondary purpose~             1. Progression-free survival and overall survival~             2. Disease stabilization ratio~             3. Duration of reaction~             4. Safety Profile~             5. Experiments on response prediction / immunological markers~   "
6091|NCT03487120|"~     A single blinded RCT for adult patients with spine pain. One group had a lumbar laminectomy~     with denervation of the facet joint at the level decompressed. The other group had a lumbar~     laminectomy without facet joint denervation. Both groups had their back pain and functional~     limitations measured using a 10 cm visual analogue scale and the Oswestry disability index~     (ODI). All measures were taken before surgery and at patients' 6, 12 and 24 week follow-up~     clinic visit.~   "
6092|NCT03487107|"~     The safety, tolerability and antiviral activity of DAG181/SOF in treatment-naive and~     treatment-experienced patients with chronic hepatitis C virus (HCV) genotype 1 infection.~   "
6093|NCT03487094|"~     Growth and Tolerance Trial of Iron-fortified infant formulas~   "
6094|NCT03487081|"~     The purpose of this study is to investigate the basic psychological and neural mechanisms~     underlying the social regulation of emotion - that is, how one person's actions can impact,~     or regulate - the emotions of another person - and how this ability changes with practice. As~     such, this study is not designed to directly address clinical health outcomes and provide no~     treatment or intervention.~   "
6095|NCT03487068|"~     Assess the renal changes in patients with non-alcoholic fatty liver (NAFLD).~   "
6096|NCT03487055|"~     This is an open labelled study. It was designed to evaluate the safety of multiple-dosing of~     TK006 in patients with breast cancer-related bone metastases. This trial is the extension of~     a core study: Phase 1 Trial of a Fully Human Monoclonal Antibody of Receptor Activator for~     Nuclear Factor-κ B Ligand (RNAKL, TK006) Safety, Pharmacokinetics, and Pharmacodynamics in~     Patients With Breast Cancer-related Bone Metastases (NCT 03239756).~   "
6097|NCT03487042|"~     Vitiligo is a chronic disorder of pigmentation characterized by the development of white~     macules on the skin due to loss of epidermal melanocytes. It affects approximately 0.5%-2% of~     general population world-wide, without predilection for sex or race.Vitiligo can be~     classified into segmental or non-segmental. Non-segmental or generalized vitiligo is the most~     common clinical presentation and often involves the face and acral regions.~      Multiple monotherapy modalities are established to treat vitiligo but the response is~     variable, unsatisfactory, and requiring a prolonged course. This problem is exaggerated by~     the multifactorial and polygenic nature of the pathomechanism of the disease. These facts~     pave the way to combination therapy that showed better and safe repigmentation response than~     monotherapy.~   "
6194|NCT03485781|"~     PROPEA3 is a prospective observational study investigating the recovery of propofol-induced~     EEG slow-wave activity and its association with neurological outcome after cardiac arrest.~   "
6195|NCT03485768|"~     This is a prospective, randomized controlled trial in a single center to explore the~     effectiveness and safety of percutaneous disc decompression with coblation nucleoplasty~     (PDCN) for the treatment of cervicogenic dizziness.~   "
6098|NCT03487029|"~     Aim: To assess whether there are different training effects on glucose concentration and~     cardiorespiratory parameters of different high-intensity training protocols in patients with~     type 2 diabetes.~      Type 2 diabetes is a highly prevalent disease associated with cardiovascular disease leading~     to high levels of mortality, morbidity and health expenditure, characterized by impaired~     glucose control during activities and reduced aerobic exercise capacity .~      Exercise training is the most effective way to improve compliance, reduce blood glucose~     concentration and increase insulin sensitivity. Training increases muscle capacity, oxidative~     capacity and glucose transport, peripheral insulin sensitivity is improved.~      Exercise training with high-intensity interval (resting and exercise period) High Intensity~     Interval Training (HIIT) is a form of exercise training that has recently been widely used in~     the management of type 2 diabetes, including short duration high intensity exercise periods~     and lower severity or passive rest periods. There are different HIIT exercise training~     programs according to physiological responses in the literature. However, long-term and~     short-term HIIT training training programs were not compared in terms of their effect on~     glucose concentration and cardiorespiratory fitness. The aim of this study was to compare the~     effects of different HIIT exercise training programs so that exercise programs for patients~     with type 2 diabetes could be planned more effectively.~   "
6099|NCT03487016|"~     The overarching hypothesis of this trial is that the NAPOLI regimen and alternating cycles of~     NAPOLI and mFOLFOX6 (seq-NAPOLI-FOLFOX) are superior to the current standard of care~     gemcitabine/nab-paclitaxel. Furthermore, we propose that the NAPOLI regimen and~     seq-NAPOLI-FOLFOX display favourable safety profiles and allow for longer first line~     treatment and higher rate of transition into the second line setting.~   "
6100|NCT03487003|"~     The use of laryngeal mask airway (LMA) is increasing in pediatric anesthesia because it~     provides lesser direct mechanical stimulation of the airway due to being placed above the~     larynx. However, LMA insertion can be more difficult in children than in adults due to their~     unique characteristics of pediatric airway. Neuromuscular blocking agents, so-called, muscle~     relaxants have long been used to facilitate insertion of airway devices. But there are pros~     and cons for the efficacy of muscle relaxants in LMA insertion, and most studies were~     investigated in adults.~   "
6101|NCT03486990|"~     This study is to characterize the safety and tolerability of an investigational drug called~     TIMP-GLIA when either one or two intravenous doses are given to subjects with celiac disease.~     The way the body reacts to TIMP-GLIA is being checked by laboratory tests of the blood and~     urine, and study participant health will also be monitored by vital signs such as blood~     pressure, electrocardiogram (ECG), and physical examination.~   "
6102|NCT03486977|"~     Study of interest of Telemedicine in establishments providing care for the dependent elderly~     (EHPAD in french) is a strategy for improving the course of care of residents, including the~     number not programmed hospitalizations, and a multidimensional analysis of the conditions of~     effectiveness of telemedicine will identify the keys to optimize its use.~   "
6103|NCT03486964|"~     Observational, retrospective study, conducted in diabetic patients aimed to evaluate the~     effects on the glyco-metabolic control and on cardiovascular events of different DPP-4~     inhibitors. Patients will be stratified in patients taking different DPP-4 in addition to~     sulfonylureas, biguanides, thiazolidinediones, insulin, compared to those in therapy with~     other hypoglycemic classes, such as sulphonylureas, biguanides, thiazolidinediones, insulin,~     alone or in combination, in primary and secondary prevention.~   "
6104|NCT03486951|"~     The aim of this prospective and observational study is to describe the conditions of~     orthognathic procedures performed in Toulouse Teaching Hospital over a one-year period, the~     outpatient-to-inpatient shifts rate and the whole outpatient rate among the whole~     orthognathic procedures done. The investigator also wants to identify factors associated with~     an outpatient-to-inpatient shift, and factors associated with the duration of~     hospitalization.~   "
6105|NCT03486938|"~     The primary objective of the study is to evaluate the efficacy of AGB101 on slowing cognitive~     and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes~     (CDR-SB) score as compared with placebo in participants with mild cognitive impairment due to~     Alzheimer's Disease (MCI due to AD) also known as prodromal AD. Participants will be~     randomized to receive placebo or AGB101 (220 mg), once daily for 78 weeks. Secondary~     objectives are to assess the effect of AGB101 compared with placebo on clinical progression~     as measured by Mini-Mental State Examination (MMSE) and Functional Activities Questionnaire~     (FAQ).~   "
6106|NCT03486925|"~     Effects of intranasal oxytocin (24IU) on cognitive control of attention~   "
6107|NCT03486912|"~     This is a study of experimental medication BMS-986036 given to adults with Nonalcoholic~     Steatohepatitis (NASH; the buildup of fat and inflammation in the liver that is not caused by~     alcohol) and liver cirrhosis (liver damage characterized by normal liver tissue being~     replaced by scar tissue).~   "
6108|NCT03486899|"~     This is a study of experimental medication BMS-986036 given to adults with Nonalcoholic~     Steatohepatitis (NASH; the buildup of fat and inflammation in the liver that is not caused by~     alcohol) and stage 3 liver fibrosis (severe fibrosis).~   "
6109|NCT03486886|"~     A promising imaging technique involving new prostate specific membrane antigen (PSMA)~     positron emission tomography (PET) tracers is emerging in metastatic prostate cancer (PCa).~     This approach has demonstrated higher sensitivity in detecting metastases, prior to and~     during therapy, than current imaging standard of care (CT and bone scan).~      PSMA is expressed in the vast majority of PCa tissue specimens and its degree of expression~     correlates with a number of important metrics of PCa tumor aggressiveness.~      [18F]DCFPyL is a promising high-sensitivity second generation PSMA-targeted urea-based PET~     probe. Studies employing second-generation PSMA PET/CT imaging in men with biochemical~     progression after definitive therapy suggest detection of metastases in over 60% of men~     imaged. In fact, PSMA-based PET has so far proven to have higher sensitivity than any other~     modality for localization of the site of recurrence. Applications that show promise and~     require further investigation include the characterization and risk stratification of primary~     PCa, complete staging of metastatic PCa to allow for PSMA-targeted radiotherapy and improved~     identification of patients with oligometastatic disease.~      The objective of this study is to explore the detection yield of PSMA-PET in a pilot cohort~     of patients at CHUM and establish the repeatability of the technique before investigating it~     more widely.~   "
6110|NCT03486873|"~     The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab~     (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who rollover~     into this extension study.~      This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase~     or 3) Second Course Phase. Each participant will roll-over to this extension study in one of~     the following three phases, depending on the study phase they were in at the completion of~     the parent study. Participants who were in the First Course Phase of study treatment in their~     parent study will enter the First Course Phase of this study and complete up to 35 cycles of~     study treatment with pembrolizumab or a pembrolizumab-based combination. Participants who~     were in the Follow-up Phase in the parent study (post-treatment or Survival Follow-up Phase)~     will enter the Survival Follow-up Phase of this study. Participants who were in the Second~     Course Phase in their parent study will enter Second Course Phase of this study and complete~     up to 17 cycles of study treatment with pembrolizumab or a pembrolizumab-based combination.~   "
6111|NCT03486860|"~     This project aims to develop and evaluate a novel early intervention program that targets the~     specific risk factors implicated in the development and persistence of shyness, social~     reticence, and withdrawal in children. The project includes a program development phase,~     Phase I (pilot test of full study procedures using developed treatment protocol), and Phase~     II (randomized controlled trial/RCT). Outcomes that will be assessed include change in child~     behavioral inhibition and parenting, using parent and teacher reports and observational data.~     Families are assessed at three time points: baseline, post-treatment (or at approximately 8~     weeks for the control group), and 2 month follow-up.~   "
6112|NCT03486847|"~     This study evaluates the incidence of postoperative atelectasis after general anesthesia with~     prone position using lung ultrasound in children age < 3 years.~   "
6113|NCT03486834|"~     This study will evaluate the safety, tolerability, and efficacy of Human Cytomegalovirus~     (CMV) vaccine V160 administered in a 2-dose or 3-dose regimen in healthy seronegative women~     16 to 35 years of age. Participants will receive blinded V160 on Day 1, Month 2, and Month 6~     (3-dose regimen), V160 on Day 1 and Month 6 and placebo at Month 2 (2-dose regimen), or~     placebo on Day 1, Month 2, and Month 6, and will be followed to approximately Month 36. The~     primary hypothesis of the study is that administration of a 3-dose regimen of V160 will~     reduce the incidence of primary CMV infection compared to placebo.~   "
6114|NCT03486821|"~     The primary objective of this study is to demonstrate that ultra-hypofractionation of~     prostate cancer does not increase urinary toxicity as defined by the EPIC-26 GU domain~     patient reported outcome.~   "
6115|NCT03486808|"~     The aim of this study is to investigate the effect of dual site-dual channel non-invasive~     brain stimulation for recovery of language and cognitive function in healthy. Simultaneous~     dual site-dual channel stimulation was applied by using two sets of transcranial direct~     current stimulation devices. All subjects will go through four conditions of transcranial~     direct current stimulation with for 30 minutes. Four conditions are 1) Dual stimulation: i)~     anodal stimulation on left inferior frontal cortex, ii) anodal stimulation on left~     dorsolateral prefrontal cortex. 2) IFG stimulation: anodal stimulation on left inferior~     frontal cortex; 3) DLPFC stimulation: anodal stimulation on left dorsolateral prefrontal~     cortex area. 4) sham stimulation~   "
6116|NCT03486795|"~     The aim of this study is to investigate the effect of dual site-dual channel non-invasive~     brain stimulation for recovery of motor function in healthy subjects. Simultaneous dual~     site-dual channel stimulation was applied by using two sets of transcranial direct current~     stimulation devices. All subjects will go through four conditions of transcranial direct~     current stimulation with for 30 minutes. Four conditions are 1) Dual stimulation: i) anodal~     stimulation on right primary motor cortex and cathodal stimulation on left primary motor~     cortex, ii) anodal stimulation on right premotor cortex and cathodal stimulation on left~     supraorbital area. 2) M1 stimulation: anodal stimulation on right primary motor cortex and~     cathodal stimulation on left primary motor cortex; 3) PMC stimulation: anodal stimulation on~     right premotor cortex and cathodal stimulation on left supraorbital area. 4) sham stimulation~   "
6117|NCT03486782|"~     The aim of this study is to investigate the effect of dual site-dual channel non-invasive~     brain stimulation for recovery of language and cognitive function in post stroke patients.~     Simultaneous dual site-dual channel stimulation was applied by using two sets of transcranial~     direct current stimulation devices. All subjects will go through four conditions of~     transcranial direct current stimulation with for 30 minutes. Four conditions are 1) Dual~     stimulation: i) anodal stimulation on ipsilesional inferior frontal cortex, ii) anodal~     stimulation on ipsilesional dorsolateral prefrontal cortex. 2) IFG stimulation: anodal~     stimulation on ipsilesional inferior frontal cortex; 3) DLPFC stimulation: anodal stimulation~     on ipsilesional dorsolateral prefrontal cortex area. 4) sham stimulation~   "
6118|NCT03486769|"~     The aim of this study is to investigate the effect of dual site-dual channel non-invasive~     brain stimulation for recovery of motor function in post stroke patients. Simultaneous dual~     site-dual channel stimulation was applied by using two sets of transcranial direct current~     stimulation devices. All subjects will go through four conditions of transcranial direct~     current stimulation with for 30 minutes. Four conditions are 1) Dual stimulation: i) anodal~     stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional~     primary motor cortex, ii) anodal stimulation on ipsilesional premotor cortex and cathodal~     stimulation on contralesional supraorbital area. 2) M1 stimulation: anodal stimulation on~     ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor~     cortex; 3) PMC stimulation: anodal stimulation on ipsilesional premotor cortex and cathodal~     stimulation on contralesional supraorbital area. 4) sham stimulation~   "
6119|NCT03486756|"~     This is a study to investigate acceptability and feasibility of a novel protocol on~     exposure-based CBT for asthma-related fear delivered over the Internet (Internet-CBT).~   "
6196|NCT03485755|"~     Single site study involving Biological Mothers and their children approximately 8-10 years~     old to assess the predominant microflora and skin physiology.~   "
6233|NCT03485274|"~     With the recent availability of vortioxetine, and the surging phenomenon of cannabis misuses~     amongst young abusers, it is a timely opportunity to conduct an early pharmacotherapy~     intervention study to offer an evidence-based strategy aiming to stop individuals with~     cannabis use disorders with depressive or anxiety symptoms, to develop into a more chronic~     disabling dependence or co-morbid state.~   "
6120|NCT03486743|"~     Preliminary data from our work with teen mothers suggest that many women would benefit from~     contraception but do not actually make visits nor initiate conversations regarding~     contraception unless the subject is raised by the clinician. Those coming for primary care~     visits discuss their conditions and care with family and friends, spreading health care~     information. A substantial proportion of citizens obtain their health information from~     friends, family, internet, social media and other non-clinicians. Thus, educating women, even~     when not coming expressly for contraceptive services, increases more accurate health~     information throughout their communities and actually identifies fertility needs, ultimately~     increasing use of contraception.~   "
6121|NCT03486730|"~     This clinical trial is looking at a drug called BT1718 in adult patients with advanced solid~     tumours. The main aim of the study is to find the maximum dose of BT1718 that can be given~     safely to patients; learn more about the potential side effects of BT1718 and how they can be~     treated and also what happens to BT1718 inside the body.~   "
6122|NCT03486717|"~     The purpose of this research study is to evaluate the effectiveness of virtual-reality~     audio-visual distraction goggles on pain and behavior scores in a population of 8-12 year old~     dental patients receiving routine dental care in an outpatient clinical setting.~   "
6123|NCT03486704|"~     The main aim of the study is to evaluate the efficacy of the Virtual Reality Rehabilitation~     System (VRRS) compared to usual care treatment for patients with MCI. Moreover, we will~     assess the possibility to prolong the beneficial effects of the treatment with an innovative~     telerehabilitation system. The effects of the intervention on outcome variables will be~     assessed using a randomized controlled trial design with three groups. The investigators will~     assess the effect of VRRS system and of the implementation of the at-home treatment on the~     quality of life, cognitive and functional abilities.~   "
6124|NCT03486691|"~     the left lobe of the liver in obese patient usually fatty and enlarged and may cause~     difficulty during bariatric surgery. the aim of this study is to test the impact of routine~     preoperative ultrasound to evaluate the size of left lobe of the liver as a preoperative~     predictor for difficulty~   "
6125|NCT03486678|"~     This is a single-arm, open-label and exploratory clinical study of PD-1 monoclonal antibody~     SHR-1210 combined with GEMOX regimen (gemcitabine combined oxaliplatin) in the treatment of~     advanced biliary malignancies.~      In oder to observe and evaluate the efficacy and safety of PD-1 antibody SHR-1210 combined~     with GEMOX in the treatment of patients with advanced biliary malignant tumor (BTC),subjects~     with pathological confirmed biliary cancer, including intrahepatic bile duct carcinoma,~     extrahepatic bile duct carcinoma, and gallbladder carcinoma will be enrolled.~      28 days as a treatment cycle, SHR-1210 3mg/kg and Gemcitabine 800 mg/m2 will be administered~     IV Q2W (D1 and D15 of a treatment cycle),and Oxaliplatin 85mg/m2 will be administered IV Q2W~     (D2 and D16 of a treatment cycle). PD-1 antibody combined chemotherapy will be used up to 6~     cycles.SHR-1210 3mg/kg IV Q2W will be administered beyond 6 cycles chemotherapy until disease~     progression or un-tolerable toxicity.~   "
6126|NCT03486665|"~     Multiple sclerosis (MS) is a chronic progressive neurological autoimmune disease, that~     gradually affects patient's quality of life. There are about 2.5 millions patients world~     wide, with an increasing cost Burdon. Up to date, it remains unclear who are the exact cells~     to initiate the disease. During the disease, the repertoire of cells expands and undergoes~     changes. The purpose of this study is to characterize those changes.~   "
6127|NCT03486652|"~     IBD-related arthropathy is one of a group of inflammatory arthritides considered as~     seronegative spondyloarthropathies, a group of disorders that also includes ankylosing~     spondylitis, psoriatic arthritis, reactive arthritis, and undifferentiated SpA. IBD-related~     SpA is mainly characterized by axial involvement but may also be associated with peripheral~     symptoms, such as synovitis, dactylitis, or enthesitis~   "
6128|NCT03486639|"~     Urodynamic examination evaluates storage and empting phases of the urinary bladder. It~     enables the clinician to correlate physiologic findings to patients' complains. The data~     gathered during the examination divided to storage and empting.~      During the storage phase, bladder sensation is measured while the bladder is filled with~     sterile water. During years of practice, we noticed that early sensation (bladder~     over-sensitivity) is occasionally associated with bladder outlet obstruction (as demonstrated~     in the emptying phase of the examination.~   "
6129|NCT03486626|"~     The participants will receive metformin 500mg 3times per day for 3months and one month is~     left for spontaneous pregnancy to occur or not (primary outcome ) and the investigators will~     check endometrial thickness and subendometerial vascularity as markers of endometrial~     receptivity before and after the treatment.~   "
6130|NCT03486613|"~     A randomised, within-participants cross-over design trial including 60 patients with~     rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis. The participants will~     be randomised to data registration of patient reported outcome measures (PROM) through the~     DANBIO app on a smartphone first and thereafter via the touch screen solution at the~     rheumatology outpatient clinic or vice versa. Outcomes are the following PROM: HAQ, VAS pain,~     VAS fatigue, VAS global Health, BASDAI, BASFI, PASS, Anchoring question, DAS28crp and ASDAS.~   "
6131|NCT03486600|"~     Fluid therapy in trauma patients is considered one of the common challenges in daily~     practice. Both crystalloids and colloids can be used to maintain adequate blood volume and~     tissue perfusion but there is an ongoing debate as both of them could affect coagulation and~     renal function. The latest generation of the commercially available Hydroxy Ethyl Starch~     (HES) solutions was developed to improve pharmacokinetics and safety profile of HES,~     minimizing adverse effects such as impairment of blood coagulation or renal function. But~     data on early fluid resuscitation in trauma patients with these starches are limited and its~     safety on coagulation and renal function is still questioned.~   "
6167|NCT03486132|"~     Episiotomy is an incision in the perineum carried out during the second stage of labour to~     facilitate the birth of an infant. It is an important surgical procedure with physiological,~     psychological and socio-economic effects on women. Therefore, not only the decision to carry~     out an episiotomy but also how it is performed and the quality of aftercare are important The~     two most often performed are the lateral and median episiotomy, as well as mediolateral~     episiotomy.~      Two common methods of repair of episiotomy include continuous and interrupted methods This~     study aims to compare between postoperative pain following repair of episiotomy by continuous~     or interrupted suturing.~   "
6132|NCT03486587|"~     Afatinib is an irreversible ErbB-family blocker with approved clinical activity in~     non-small-cell lung cancer (NSCLC) with EGFR mutations. It has received regulatory approval~     for use as a treatment for patients with lung adenocarcinoma whose tumors harbour activating~     EGFR mutations within exons 18-21 of the EGFR receptor, or patients with lung squamous cell~     carcinoma whose disease progress after platinum-based doublet chemotherapy. However, diarrhea~     is the most commonly reported adverse events associated with afatinib treatment (> 90%).~     Although these events are generally mild to moderate in severity, diarrhea adversely affects~     the tolerability of cancer treatment, and in severe cases diarrhea has the potential to~     affect the efficacy of treatment due to poor compliance, or treatment interruption, or dosage~     reduction. Currently, no prophylactic measure was demonstrated efficaciously. Bacillus cereus~     is an aerobic spore-forming bacterium that is commonly found in soil. The efficacy of~     Bacillus cereus in the management of afatinib treatment-associated diarrhoea has not been~     extensively evaluated in clinical studies. This is a single-arm, single-institutional, phase~     II study evaluating the efficacy and safety of Bacillus cereus (Changfukang®) in the~     prevention of afatinib-associated diarrhea in NSCLC patients.~   "
6133|NCT03486574|"~     Familial gastric cancer accounts for 10% of all cases, but predisposing genetic variations is~     unknown except for CDH1 mutation.~      Because Germline mutation is believed to be a key aspect of cancer predisposition, we plan to~     recruit persons with 2 or more affected family members in three-generation pedigree. The~     investigators will perform a whole-exome sequencing using DNA from blood samples of families~     including gastric cancer patients and non-gastric cancer patients~   "
6134|NCT03486561|"~     The rationale of MIDA trial is to determine efficacy and tolerability of ranolazine molecule~     among Pakistan population and obtain firsthand knowledge about the molecule ranolazine.~   "
6135|NCT03486548|"~     This study evaluate the efficacy of adding popliteal sciatic nerve block with low~     concentration bupivacaine and dexamethasone to abductor canal block for total knee~     arthroplasty in patient with NSAIDs prescribing precaution. Half of participants will receive~     popliteal sciatic nerve block, abductor canal block and periarticular injection, while the~     other half will receive a sham block, abductor canal block and periarticular injection.~   "
6136|NCT03486535|"~     Background and objectives: The investigators are performing this study to explore whether the~     presence of diabetes mellitus (DM) will affect the outcomes of infraclavicular brachial~     plexus blocks (ICBs) in patients undergoing elbow, forearm and hand surgery.~      The primary hypothesis is that the sensory block duration will be delaying in diabetic~     patients.~      Methods: Ethics committee approval has been obtained and after written informed consents, 60~     patients are planning to be enrolled to the study. Diabetic patients will be included in~     Group DM and non-diabetics are included in Group NODM. All patients will receive~     ultrasound-guided ICBs with the mixture of 15 mL lidocaine 2% and 15 mL bupivacaine 0.5%. Our~     primary outcome is sensory block duration, and secondary outcomes are sensory and motor block~     onset times, motor block duration, time-to-first-pain (numeric rating scale (NRS)~      ≥4), postoperative NRS scores and rescue analgesic consumption (NRS) ≥4) through the~     postoperative first 2 days. All outcomes will be assessed by blind investigators.~   "
6137|NCT03486522|"~     Epidemiology of Sexually Transmitted Diseases (STDs) in women admitted in a Family Planning~     for a termination of pregnancy is poorly defined currently in France. Only one bi-centre~     study (Bourgeois-Nicolaos, 2015), performed in two Family Planning suburban centres located~     within University Hospital (Assistance Publique-Hôpitaux de Paris), found high prevalence: C.~     trachomatis 15.1%, N. gonorrhoeae 3.1%. Moreover, heterogeneity can occur between centres. In~     students in Sweden, 26% had one or several previous STDs, mainly C. trachomatis and Human~     Papilloma Virus (HPV). Having previously a termination of pregnancy was a risk factor of~     STDs. Systematic screening for STDs in Women Admitted in Family Planning for a Termination of~     Pregnancy appears thus a logical strategy.~   "
6138|NCT03486509|"~     As a 2nd generation EGFR-TKI that irreversibly binds to EGFR receptors, afatinib is currently~     recommended as the standard first-line treatment for EGFR mutation-positive lung cancer, and~     clinical studies are also being actively conducted in other types of carcinomas characterized~     by EGFR gene mutation and overexpression.~      The overall results from previous studies of gefitinib and erlotinib as EGFR TKIs , as well~     as from preceding studies of afatinib - a 2nd generation EGFR TKI - suggest the possibility~     of an effective therapy in esophageal cancer or squmaous lung cancer. In this phase II trial,~     afatinib shall be administered to patients with squamous cell carcinoma of esophagus or lung~     squamous cell carcinoma to evaluate its effects and toxicity. Also, biomarkers to predict~     responses to afatinib shall be explored through further studies.~   "
6139|NCT03486496|"~     Rationale:~      Advanced non-small-cell lung cancer (NSCLC) patients harboring epidermal growth factor~     receptor (EGFR) mutations (del19 or L858R) show an impressive progression-free survival~     between 9 and 11 months when treated with gefitinib. Combination of gefitinib and berberine~     could improve efficacy in lung cancer with EGFR mutation in vivo and vitro. The investigators~     hypothesize that progression-free survival could be improved by combination of gefitinib and~     berberine.~   "
6140|NCT03486483|"~     The aim of the present study was to assess whether supervised slackline training improves~     postural control in children and teenagers with spastic cerebral palsy (grade I and II of the~     Gross Motor Function Classification System).~   "
6141|NCT03486470|"~     The purpose of this study is to determine if there is a difference in the size and the depth~     of the radial artery at the access points for established radial and new distal radial~     approach for the arteries of both arms~   "
6142|NCT03486457|"~     This is a 6 month study investigating the effectiveness and safety of tofacitinib in treating~     signs and symptoms and improving physical function in Chinese patients with active psoriatic~     arthritis and had inadequate response to a conventional synthetic disease modifying~     anti-rheumatic drug. This is a China alone study.~   "
6168|NCT03486119|"~     The study aimed to elucidate predictive immune related biomarker to the responsiveness to the~     PD-1 blockade and evaluate the dynamics of immune cells in peripheral blood from NSCLC~     patients during nivolumab treatment.~      Hypothesis that The ratio of MDSC after 1st or 2nd cycle can predict the response to~     nivolumab in NSCLC patients earlier than the tumor assessment by imaging scan.~      The primary objective is to determine whether myeloid-derived suppressor cell (MDSC) ratio~     after 1st or 2nd cycle of nivolumab can be accurate predictive biomarkers of nivolumab in~     advanced NSCLC.~   "
6143|NCT03486444|"~     This is a Phase I study to assess feasibility. There will be no impact on clinical care based~     on this study. The ultrasound system is FDA approved and could be used for clinical care~     independent of this research study. When a subject receives an ultrasound examination as part~     of standard of care or within another clinical research trial, such an examination may serve~     for an intra-individual comparator examination between conventional and new, ultra-portable~     ultrasound imaging. Patients will be identified in the clinical setting when appropriate and~     will be appropriately approached for consent for a combination of ultrasound with the~     physical exam, for medical student education, IV access, and novel application. Patients will~     be enrolled and accounted for in the appropriate sub-population. Additionally, to understand~     the impact of ultraportable ultrasound, survey tools will be used to understand the workflow~     and clinical care applications and integration of these devices. All staff and student~     members will be appropriately consented; however, the investigators anticipate that this~     portion of the study will be minimal risk with online consent waivers. Finally, the volunteer~     population will allow us to practice the use of this equipment and understand the limitations~     and applicability. The results will be the images acquired as well as surveys from the~     volunteers and those performing the scans, who will be enrolled in the staff population of~     this study. No significant risk is identified for subjects in this study. The largest risk,~     although still minimal, is an incidental finding. For this study, subjects will have the~     choice if they would like to be informed of an incidental finding. Reporting of incidental~     findings will be conducted by designated study staff after appropriate consultation and~     examination of the images by the PI or designee. While there are no direct benefits for~     subjects in this study, the study hopes to improve the implementation of ultrasound into the~     clinical setting into the future. This Phase I study aims to examine the feasibility of~     implementation and the impact on the clinical setting. Additionally, this study hopes to~     examine the utility and usefulness of ultrasound in medical education and thereby hopes to~     improve the physical exam skills of clinicians for the future.~   "
6144|NCT03486431|"~     Stereotactic ablative body radiotherapy (SABR) can be considered for patients with so-called~     oligometastatic disease. However, since this is a relatively new technique, information on~     the optimal scheduling is lacking. Even prospective randomized trials on SABR for~     oligometastases typically allow different fractionation schedules to be used. This is~     especially true for non-spine bone and lymph node metastases, where the literature is scarce~     to non-existent.~      There is also emerging evidence that SABR can stimulate the immune response, by a variety of~     mechanisms such as increasing TLR4 expression on dendritic cells, increasing priming of T~     cells in draining lymph nodes, and increasing tumor cell antigen presentation by dendritic~     cells. Again, it is not clear which fractionation schedule elicits the most robust immune~     response.~      Therefore, it is opportune to compare the most commonly used stereotactic regimens regarding~     toxicity, efficacy, and immune priming.~      This trial is a non-randomized prospective phase I trial determining a regimen of choice for~     patients with non-spine bone and lymph node oligometastases (≤ 3 lesions). The metastatic~     lesion(s) must be visible on CT and < 5 cm in largest diameter. A total of ninety patients~     will be consecutively included in three different fractionation regimens. They will be~     offered stereotactic ablative radiotherapy to all metastatic lesions in 5, 3 or 1 fractions.~     Dose-limiting toxicity (DLT), defined as any acute grade 3 or 4 toxicity, will be recorded as~     the primary endpoint. Overall acute and late toxicity, quality of life, local control, and~     progression-free survival are secondary endpoints.~      Liquid biopsies will be collected throughout the course of this trial, i.e. at simulation,~     after each fraction and at 6 months after the end of the radiotherapy. Translational research~     will focus on assessment of circulating cytokines and flow cytometry analysis of immune~     cells.~   "
6145|NCT03486418|"~     The aim of the study is to develop a score system in order to differentiate adenomatous~     polyps, hyperplastic polyps and serrated adenomas on the basis of optical features.~     Endoscopic images of colorectal polyps will be collected from a prospectively managed~     database. Histopathological diagnoses are available for all polyps. Histopathological~     diagnoses serve as gold standard in this study.~      In the first phase of the study optical features of serrated adenomas are extracted from the~     database. Discriminators are then defined on the basis of the extracted features. In the~     second phase a test set of high quality pictures are provided to both novices and experts of~     colorectal endoscopy. Participants are asked to use the above named discriminators in order~     to rate pictures and to classify polyps into three classes (adenomatous polyps, hyperplastic~     polyps and serrated adenomas). In the third phase of the study accuracy of optical bases~     diagnoses is calculated by comparing optically derived diagnoses with histopathological~     diagnoses (gold standard).~   "
6146|NCT03486405|"~     The purpose of this study is to examine the effectiveness of telehealth via video feedback to~     transition rear foot strike runners to non-heel strike runner following a lower extremity~     injury. Telehealth re-education gait training is much cheaper than in-clinic retraining~     sessions with a medical provider and could be much more widely used by both consumers and~     researchers as a training aid, a way to help alter running form, prevent running injuries and~     be used as a tool for use in the rehabilitation of running related injuries.~   "
6147|NCT03486392|"~     The purpose of this study is to assess the effects of JNJ-64565111 compared with placebo~     after 26 weeks of treatment on the percent change in body weight from baseline and to assess~     the safety and tolerability, in non-diabetic severely obese participants.~   "
6148|NCT03486379|"~     The aim of this study is to investigate the activity of Folfiri as Third line of treatment in~     mGC progressed after ramuciramb-based second line.~   "
6149|NCT03486366|"~     Epilepsy affects 1% of the world's population and 6 million people in Europe. The estimated~     total cost of €20 billion in Europe in 2014 makes epilepsy a significant socioeconomic~     burden. Despite great progress in the management of epilepsy and increasing numbers of~     antiepileptic drugs, 30-40% of epilepsy patients are refractory to all available medications.~     Moreover, in childhood epilepsy is a causative factor of psychiatric and behavioral~     comorbidities, including developmental delay and autism spectrum disorder. In spite of~     multiple trials no reliable biomarker of epilepsy development has been identified. There are~     no studies on biomarkers of drug-resistance or epilepsy recurrence after the drug withdrawal.~     EPIMARKER is a first project, carried out in humans, which is going to examine in prospective~     way clinical, electroencephalographic and molecular biomarkers to produce an integrative tool~     useful in everyday diagnosis and treatment of epilepsy in children to prevent the development~     of drug-resistant epilepsy and its behavioral comorbidities as mental retardation and autism.~     The set of molecular biomarkers will be determined by quantitative transcriptomic and~     proteomic studies and validated in reprogrammed cellular models.~   "
6150|NCT03486353|"~     The primary objective of the study is to determine the response rate according to the~     International Working Group Response criteria for the combination of FF-10501-01 and~     azacitidine in patients previously untreated with hypomethylating agents, with Int2/High risk~     MDS according to the IPSS, and Intermediate/High/Very-High risk MDS according to the IPSS-R,~     or who are otherwise candidates for treatment with azacitidine.~   "
6151|NCT03486340|"~     This is a prospective, exploratory, randomised clinical trial. Patients with diagnosed cancer~     that are to be treated with 5-fluorouracil (5-FU) will be randomised into standard~     oncological treatment or a cardiological assessment prior to the 5-FU treatment. The~     investigators hypothesize that aggressive management of ischemic risk factors in asymptomatic~     patients will reduce the number of hospitalisations and investigations for acute coronary~     syndrome during and after 5-FU treatment and that patients with high coronary artery calcium~     scores are more likely to experience chest pain during the treatment with 5-FU.~   "
6152|NCT03486327|"~     This is an exploratory, single center, open label, parallel-dose, and prospective study of~     BR55 CEUS for characterization of solid pancreatic lesions in subjects with suspected PDAC~     using transabdominal US.~   "
6155|NCT03486288|"~     Older people are a rapidly growing proportion of the world's population and their number is~     expected to increase twofold by 2050. When these people become patients that require surgery,~     they are at particular high risk for postoperative delirium (POD), which is associated with~     longer hospital stays, higher costs, risk for delayed complications and cognitive dysfunction~     (POCD). Having suffered an episode of delirium is furthermore a predictor of long-term care~     dependency. Despite these risks, an increasing number of elderly undergo major elective~     surgery. This is reflected by the frequency of elective spinal surgery, in general, and~     instrumented fusions, in particular, which has markedly increased over the past few decades.~      It is yet insufficiently understood, which, particularly modifiable, factors contribute to~     the development of POD and POCD following these major but plannable surgeries. A better~     understanding of risk factors would facilitate informed patient decisions and surgical~     strategies could be tailored to individual risk profiles.~   "
6156|NCT03486275|"~     We produced a prototype video game called Hygie on the 5 most common reasons of consultation~     in general practice using 9 articles from independent journals based on evidence (reviews by~     Prescrire and Minerva). We then carried out a randomized trial comparing the learning~     provided by a week of access to the game versus source articles, in a population of clinical~     supervisors (CS) from 13 French departments of general practice.~   "
6157|NCT03486262|"~     Retrospective inclusion of lung cancers developed in a context of idiopathic pulmonary~     fibrosis, diagnosed and / or treated in participating centers. The cases are recovered~     retrospectively from the records of the pulmonology and pathology departments of our various~     partners.~   "
6158|NCT03486249|"~     Weaning failure is associated with prolonged duration of mechanical ventilation that itself~     can worsen patient's prognosis. Therefore, identification of the causes and mechanisms~     leading to weaning failure is important in daily practice. While diaphragm dysfunction and~     pulmonary edema are two main causes of weaning failure, there are currently no data that~     quantify their respective contribution neither their potential co-existence. During weaning~     from mechanical ventilation, heart and lung interaction plays a major role. As a key factor,~     diaphragm function is therefore certainly involved in the occurrence of weaning-induced~     pulmonary edema. However, both phenomenons diaphragm dysfunction and weaning induced~     pulmonary edema have not been simultaneously investigated so far. This current project aims~     at exploring the relationship between diaphragm dysfunction and pulmonary in patients~     experiencing weaning failure. The objectives are 1) to quantify the respective contribution~     and co-existence of diaphragm dysfunction and weaning induced pulmonary edema and 2) to~     investigate the role of diaphragm function in the occurrence of weaning induced pulmonary~     edema.~   "
6159|NCT03486236|"~     This study evaluated the safety and pharmacokinetics of multiple ascending doses of VX-440 in~     combination with tezacaftor/ivacaftor (TEZ/IVA) (triple combination [TC]) administered for 13~     days to healthy male and female subjects~   "
6160|NCT03486223|"~     The purpose of this study is to test how soluble epoxide hydrolase (sEH) inhibition with~     GSK2256294 affects tissue sEH activity and insulin sensitivity.~   "
6161|NCT03486210|"~     More than 50,000 patients in France benefit from bariatric surgery every year. However,~     nutritional complications (protein malnutrition, hypoglycaemia) are common and primary or~     secondary weight failures (weight recovery) account for almost 20% of operated. Weight loss~     and the metabolic effects of surgery are not related only to a reduction in dietary intakes,~     but also to mechanisms independent of caloric reduction, such as eating behaviour after~     bariatric surgery (Gastric Bypass or sleeve gastrectomy). These choices are guided by~     perceived changes in the properties of the food, resulting in changes in tastes, palatability~     and more generally food preferences. Among available tools to evaluate dietary preferences we~     selected the Food Leeds Preference Questionnaire (FLPQ) to assess those modifications. During~     this test, photographs of food products classified according to predetermined characteristics~     are presented with different instructions and response design to estimate liking, wanted for~     food, implicitly or explicitly. Our main hypothesis is that the use of the Food Leeds~     Preference Questionnaire will highlight differences in dietary preferences according to the~     type of bariatric surgery performed.~      We will be conducted a study observational study on three parallel groups: a control group~     composed of patients suffering from unoperated obesity, a group of patients operated for a~     sleeve gastrectomy and a group of patients operated for a gastric bypass. We will include 45~     patients per group. The patients will have to pass the Leeds Food Preference Questionnaire~     (LFPQ). Our judgment criterion will be the degree of food preference assessed using the LFPQ.~     Participants will also be assessed on behavioural parameters with the Binge Eating Scale, the~     Yale Food Addiction Scale Version 2.0 and the Urgency, lack of Premeditation, lack of~     Perseverance and Sensation seeking Impulsive behavior scale (UPPS-P) short version.~   "
6162|NCT03486197|"~     This phase II trial studies how well neutron radiation therapy and pembrolizumab work in~     treating participants with urothelial carcinoma that has spread to other places in the body.~     Neutron radiation therapy uses high energy neutrons to kill tumor cells and shrink tumors.~     Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells~     to grow and spread. Giving radiation therapy and pembrolizumab may work better in treating~     participants with urothelial carcinoma that has spread to other places in the body.~   "
6163|NCT03486184|"~     Postoperative Acute Kidney Injury in Patients Undergoing Prolonged Neurosurgical Operations~   "
6164|NCT03486171|"~     In prehospital emergency setting, tracheal intubation is a frequent procedure (8% of~     interventions). Its objective is to control and protect upper airways and to optimize~     ventilation and oxygenation in patients with life-threatening distress. Intubation is a~     technical procedure which is associated with few difficulties with, in rare cases, the~     impossibility to do it. There are specificities of the out-of-hospital emergency with some~     risk factors that have been recognized in this context as well as the impossibility of~     assessing predictive factors of difficult intubation linked to the patient. The objective of~     the investigators was to describe the quality of tracheal intubation in prehospital emergency~     setting.~   "
6165|NCT03486158|"~     The aim of this study is to prove that getting immediate calprotectin test results on the~     patients smartphone, will both stimulate patients with inflammatory bowel disease (IBD) to~     closer follow up of their disease, and that immediate automatic e-mails to a IBD-nurse will~     lead to earlier decision-making on further treatment and follow-up by health personnel~     (optimized medication, endoscopy etc).~   "
6166|NCT03486145|"~     It is hypothesized that the daily supplementation of a nitrate-rich, two-ounce fruit and~     vegetable energy supplement (Isagenix International LLC) by healthy young adults with a would~     increase circulating nitrates and improve cardiovascular parameters compared to a~     nitrate-deficient placebo (prune juice).~   "
8947|NCT03449732|"~     After conduction a pilot study, pupillary dilation reflex (PDR) is measured in response to~     nociceptive stimulation perioperatively in infants, children and adolescents.~   "
6170|NCT03486093|"~     Central Line-Associated BloodStream Infections (CLABSIs) are responsible for many deaths in~     the United States annually.~      Several collaboratives have demonstrated the preventability of these infections.~      Educational interventions decrease rates of CLABSIs. In addition to training, education, and~     surveillance, important prevention practices include the use of chlorhexidine skin~     antiseptics and maximal sterile barrier precautions at catheter insertion. Other maintenance~     practices include hand hygiene before handling catheters or catheter sites, chlorhexidine for~     skin antisepsis with dressing changes, and disinfecting catheter hubs or injection ports with~     an appropriate agent before accessing the catheter.~      Antimicrobial catheter locks, including nonantibiotic antiseptic locks (such as alcohol or~     trisodium citrate), have also demonstrated some success in reducing CLABSIs. In particular,~     alcohol-impregnated port protectors and needleless neutral pressure connectors significantly~     reduced rates of CLABSIs.~      Respiratory semi-intensive care units (RICUs) usually work as step-up units within acute~     care hospitals to manage patients with respiratory failure with non-invasive ventilation.~     These units may provide multidisciplinary rehabilitation and serve as a bridge to home-care~     programs or long-term care facilities. Some of these RICUs may work also as step down units~     for difficult to wean patients.~      The investigators performed a single-centre prospective randomized clinical trial with the~     aim to assess the efficacy of educational interventions alone and combined with port~     protector as adjuvant tool on rate of CLABSIs. Moreover, the investigators evaluated the~     effects of previously mentioned interventions on rates of CVC colonizations and contaminated~     blood cultures.~   "
6171|NCT03486080|"~     A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of~     Dutogliptin in Combination with Filgrastim in Early Recovery Post-Myocardial Infarction~   "
6172|NCT03486067|"~     Study CC-93269-MM-001 is an open-label, Phase 1, dose escalation (Part A) and expansion (Part~     B), first-in-human clinical study of CC-93269 in subjects with relapsed and refractory~     multiple myeloma.~   "
6173|NCT03486054|"~     The pathogen inactivation (PI) system for Whole Blood (WB) using Amustaline (S-303) and~     Glutathione (GSH) has a potential to decrease transfusion-transmitted infection. There is~     scientific basis to hypothesize, that cells containing DNA and RNA such as bacteria, viruses~     and parasites that could be present in blood collected from asymptomatic infected donors are~     inactivated in the treated whole blood and therefore reduce the risk of~     transfusion-transmitted infections. The aim of the study is to gather data to support the~     safety of whole blood products that underwent treatment with amustaline and glutathione and~     data to support a larger sufficiently powered efficacy study. This study will evaluate the~     safety of the system for whole blood in adult cancer patients with anemia.~      This study has a two-stage design. Stage 1 is designed as a randomized, double-blind stage,~     followed by Stage 2, an open-label, single arm treatment escalation stage. The aim is to~     explore the safety of the whole blood product treated with a PI system using amustaline and~     glutathione.~      The study will enroll 30 patients with anemia due to underlying cancer. In stage1, 20~     patients will be randomized either to treated WB (Test) or conventional WB (Control).~      After safety assessment in Stage 1, Stage 2, a dose escalation stage will follow and enroll~     additional 10 patients in need of 2 WB products administered successively to correct anemia.~   "
6174|NCT03486041|"~     This study will be the first randomized controlled trial of Comprehensive Behavior~     Modification (ComB) as a treatment of trichotillomania (TTM). ComB treatment (12 weekly~     sessions, following a manual developed in an earlier treatment development project) will be~     compared to Minimal Attention Control among adults (N = 42) with TTM.~   "
6175|NCT03486028|"~     California counties are in the process of implementing a Centers for Medicare and Medicaid~     Services Medicaid 1115 Substance Use Disorder (SUD) demonstration. The demonstration requires~     that patients be assigned to addiction treatment settings and levels of care systematically,~     using comprehensive biopsychosocial assessments and guided by the American Society of~     Addiction Medicine (ASAM) patient placement criteria.~      RTI International, a nonprofit research institute, and University of California Los Angeles~     (UCLA) Integrated Substance Abuse Programs have been awarded a contract from the Patient~     Centered Outcomes Research Institute (PCORI) to study the effects of the ASAM implementation~     in California. The California 1115 SUD demonstration provides a unique opportunity to learn~     about the benefits and challenges resulting from system-wide implementation of ASAM criteria.~      The study will involve surveying patients in counties that are using the ASAM criteria and in~     counties that have not yet adopted the ASAM criteria. Medicaid patients receiving addiction~     treatment will be offered the opportunity participate in the study and to be surveyed about~     their experiences in treatment. The study will also analyze data from the California Outcomes~     Management System (CalOMS) and conduct interviews with providers, patients, and policymakers~     in the state. The results of the study will help inform California's efforts to continually~     improve its addiction treatment systems to better meet the needs of it communities. This~     study will also produce important and useful information to patients seeking treatment for~     addiction, and their providers, SUD system administrators, and payers.~   "
6176|NCT03486015|"~     This study evaluates the pain relieving effect of oral glucose during hip examinations on~     healthy, fullterm infants.~   "
6177|NCT03486002|"~     This study is designed to compare the effectiveness of a closed suction system with an~     inflatable balloon on the catheter (Cleansweep system) to that of a standard closed suction~     system in terms of reducing the interior resistance of endotracheal tubes. Subjects who~     require frequent suctioning ( > every 2.5 hours) and who have stable cardiovascular systems~     will be randomized to receive suctioning either through the Cleansweep system or standard~     system initially followed by the corresponding system. The subjects will be suctioned every~     two hours for eight hours ( the first 2 suction procedures with one system followed by 2 with~     the other system). After each suction procedure measurements of resistance will be made using~     peak and plateau pressures.~      Analysis: For each patient, data for both procedures on each catheter system will be pooled~     and mean differences between the standard system and the Cleansweep system will be~     calculated. For all 20 patients the mean (+/- SD) of these differences will be calculated and~     significance will be sought using appropriate statistical tests. The study will be unblinded~     and randomization determines merely which system will used initially for the first 2~     procedures.~   "
34480|NCT03115242|"~     This is a biomedical, single-center, and prospective study of a consecutive patients cohort~     in acute ischemic stroke with carotid plaque.~   "
6178|NCT03485989|"~     With advancing age, older adults are susceptible to vitamin and mineral deficiencies for a~     variety of reasons. Nutrient-dense food sources of vitamin E and other key vitamins and~     minerals, like hazelnuts, may offer a simple means of improving nutritional status of healthy~     older adults.~      This hypothesis is that individuals eating hazelnuts everyday will result in measurable~     increases in magnesium and vitamin E levels, two under-consumed micronutrients among older~     adults. Thus, subjects will consume two ounces (56 g) of hazelnuts each day for sixteen~     weeks. Investigators will measure vitamin E and magnesium levels along with a general~     assessment of micronutrient status as primary outcomes. Since nuts are nutrient-rich sources~     of unsaturated fatty acids but low in carbohydrates, changes in fasting glucose, lipid and~     lipoprotein profiles, and BMI will also be determined (secondary outcomes).~   "
6179|NCT03485976|"~     15 patients with PRP will be treated with ixekizumab for 24 weeks to determine safety and~     efficacy. Participants are required to travel to Portland, OR only for the first visit and~     week-24 visit. 5 visits in between these times and one follow up visit may be performed by~     secure videoconferencing.~   "
6180|NCT03485963|"~     This is a phase I, multi-site, study of the safety, immunologic and virologic responses of ex~     vivo expanded HIV-1 multi-antigen specific T-cell therapy (HST-NEET) as a therapeutic~     strategy in HIV-infected individuals suppressed on antiretroviral therapy (ART).~   "
6181|NCT03485950|"~     The goal of this clinical research study is to learn if the study drug ceftolozane-tazobactam~     is more effective in controlling febrile neutropenia (fever and low white blood cell counts)~     than using approved antibiotics in patients with cancer. The safety of ceftolozane-tazobactam~     will also be studied.~      This is an investigational study. Ceftolozane-tazobactam is FDA approved and commercially~     available to treat certain types of infections. It is not approved for the treatment of~     febrile neutropenia, either by itself or in combination with other antibiotics. Its use to~     treat febrile neutropenia is investigational.~      All other antibiotics given on this study are FDA approved and commercially available for the~     treatment of infections. However, only cefepime is specifically FDA approved to treat febrile~     neutropenia. The study doctor can explain how the study drugs are designed to work.~      Up to 100 participants will take part in this study. All will be enrolled at MD Anderson.~   "
6182|NCT03485937|"~     The purpose of this research is to look at how educational videos might affect patient~     satisfaction and anxiety before Mohs surgery day. Patients will be randomized to either: 1) a~     group that receives educational videos before the visit in addition to standard-of-care~     written and verbal instructions OR 2) a group that receives only standard-of-care written and~     verbal instructions.~   "
6183|NCT03485924|"~     The objective of this paired cohort study is to evaluate the diagnostic accuracy of~     Endoscopic Ultrasound-fine needle aspiration (EUS-FNA) with rapid onsite evaluation (ROSE)~     compared to EUS-fine needle biopsy (EUS-FNB) without ROSE. If EUS-FNB without ROSE is shown~     to be non-inferior to the current standard of care of EUS-FNA with ROSE in pancreatic~     lesions, this study has the potential to make EUS-guided tissue acquisition more economical~     (with elimination for the need for cytopathology staff onsite) as well as provide core~     histological specimen without sacrificing the overall diagnostic yield.~   "
6184|NCT03485911|"~     This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial to~     evaluate the efficacy and safety of oral BCX7353 in preventing acute angioedema attacks in~     patients with Type I and Type II HAE.~   "
6185|NCT03485898|"~     The purpose of the study is to assess the mortality of patient discharged from the~     specialized cognitive-behavioral unit (UCC) of Toulon.~   "
6186|NCT03485885|"~     The aim of the present study is to describe the bioavailability for the proprietary~     standardized maqui berry extracts Delphinol® and MaquiBright® enriched in anthocyanins and in~     particular delphinidins. The analyses are based on two selected key substances namely~     delphinidin-3-glucoside and cyanidin-3-sambubioside and their metabolism to phenolic acids.~      The bioavailability of anthocyanins specific for Delphinol®/MaquiBright® was analyzed in~     plasma sample kinetics (at 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h and 8h after intake of 1000mg~     standardized maqui berry extract in capsules) in 12 healthy subjects.~   "
6187|NCT03485872|"~     The purpose of this study is to increase awareness and timely treatment of urinary~     incontinence through a self-screening process. This is a 3 month study involving 2~     activities; one taking place at the beginning of study and another 3 months later.~     Participants will be randomized into experimental and control groups. The experimental group~     will receive a demographic questionnaire, quality of life questionnaire, a questionnaire~     pertaining to urinary symptoms, information about how to self-screen for urinary incontinence~     and information regarding how to refer oneself to urinary incontinence resources. The control~     group will receive the demographic and quality of life questionnaires only. It is estimated~     that it will take participants 20-30 minutes to complete their package of questionnaires.~     After 3 months, the participants will receive a phone call inquiring into what actions they~     have taken regarding their urinary incontinence.~   "
6188|NCT03485859|"~     There have been no studies exploring the efficacy of incision support using an elastic~     abdominal binder after laparoscopy to date. The investigators performed therefore a~     randomized controlled trial to determine the effect of post-laparoscopic abdominal binder use~     on enhanced recovery after surgery (ERAS) in patients with gynecologic disease.~   "
6189|NCT03485846|"~     The purpose of this study is to confirm that combination of Narlaprevir, Ritonavir and~     Daclatasvir is safe and highly effective regimen in treatment-naїve patients with chronic~     hepatitis C (HCV) genotype 1b infection.~   "
6190|NCT03485833|"~     The purpose of the study is to verify the efficacy of using end-expiratory and~     end-inspiratory occlusion tests as an index of fluid responsiveness in mechanically~     ventilated patients with cardiac surgery.~   "
6191|NCT03485820|"~     This study evaluates a program designed to help individuals transition home from inpatient~     rehabilitation following an ischemic or hemorrhagic stroke. Half of the participants will~     receive a stroke education program while the other half will receive an environmental~     modifications program.~   "
6192|NCT03485807|"~     This study will examine whether mindfulness meditation training - which a growing body of~     research indicates has manifold benefits for behavior regulation, emotion regulation, and~     other salutary outcomes of relevance to this proposal - predicts lab-based and daily~     life-based neural and behavioral outcomes indicative of reduced retaliatory aggression and~     associated anger and interpersonal conflict.~   "
6197|NCT03485742|"~     The study (Statin Eligibility Prior to myocardial infarction (MI) in Jordanians, StatinEPIC)~     is~        1. Cross sectional~        2. Non interventional~        3. One encounter per patient. No follow up. It addresses a major issue of primary~          prevention in Jordanians especially the young population, namely the issue of lipid~          lowering agents before sustaining an acute MI. A recent study in USA showed that 50% of~          patients who sustained MI were not eligible to statins had they been evaluated before~          the heart attack. It is largely unknown if a larger percentage of Middle Eastern~          patients who sustain a heart attack would be eligible to receive lipid lowering agents.~   "
6198|NCT03485729|"~     This is a a Simon's two-stage, non-randomized, open label, 2-arm Phase II trial of ONC201 in~     women with metastatic or recurrent Type II endometrial cancer who failed at least 1 prior~     chemotherapy regimen.~   "
6199|NCT03485716|"~     The aim of this study is to systematically Analyse the metabolome in capillary blood of~     healthy men and women at rest and during defined standardized physical activity under~     normobaric normoxia or hypoxia with a specific focus on metabolites and metabolic pattern~     related to energy metabolism. The metabolome analyses in capillary blood could give us also~     or more detailed insight into erythrocyte metabolic physiology because it is known for a~     longer time that the primary metabolism of the erythrocyte reflects its Oxygen Saturation via~     the glycolytic metabolites / intermediates pattern.~   "
6200|NCT03485703|"~     The introduction of invasive mechanical ventilation in the treatment of preterm infants works~     as an adjuvant in the treatment of acute respiratory failure, which has resulted in~     significantly significant survival rates. In recent years there has been an increase in the~     number of evidence that mechanical factors can cause lung injury through inflammatory cells~     and soluble mediators.~      The alveolar and airway epithelium is an important source of cytokine release. Cytokines are~     very low molecular weight proteins or glycoproteins with hormone-like actions. They~     contribute to the pathogenesis of various diseases through the ability to induce other~     inflammatory mediators Mechanical ventilation strategies can increase pulmonary and systemic~     cytokines and lead to dysfunction of multiple organs and systems.~      Azithromycin has a potent anti-inflammatory and immunomodulatory effect It suppresses the~     production of proinflammatory cytokines (IL-6, IL-1, and TNF-α), has effective antimicrobial~     properties against Ureaplasma and, best of all, few side effects The hypothesis of this study~     is that azithromycin would reduce pulmonary inflammation induced by mechanical ventilation in~     premature infants, conferring a protective character.Randomized clinical trial: use of~     azithromycin in preventing pulmonary damage newborn preterm undergoing mechanical ventilation~   "
6201|NCT03485690|"~     The Time-based Register and Analysis of COPD Endpoints (TRACE) study is prospective cohort~     study aiming at evaluating COPD patients using simple basic tools normally used in the clinic~     at hand of any physician. The objective of the study is to accomplish specific aims. 1)~     describing the disease variation over time. 2) defining different disease behaviours; and 3)~     evaluating the impact of different therapeutic approaches on this behaviour in the different~     patient types. TRACE is a single center non-interventional prospective observational cohort~     study of COPD patients. Upon identification of cases, patients are followed-up in yearly~     visits sine die until death or lost to follow-up. Starting in 2012, during the yearly visits~     clinical, functional, radiological and analytical information is recorded via a standardized~     questionnaire. Variables recorded were: socio-demographics, tobacco history, comorbidities,~     clinical presentation during the previous year, exacerbations and hospitalization in the~     previous year, current pharmacological and non-pharmacological treatments, and complementary~     tests, including at least chest radiology, pre- and post-bronchodilator spirometry, and~     analytical results. Endpoints include a variety of clinically relevant variables including~     disease phenotypic expression, diagnostic measures and therapeutic responses.~   "
6202|NCT03485677|"~     Primary Objective:~      Evaluate the safety and pharmacokinetics of eliglustat in pediatric patients (≥2 to <18 years~     old).~      Secondary Objective:~      Evaluate the efficacy of eliglustat and quality of life in pediatric patients (≥2 to <18~     years old).~   "
6203|NCT03485664|"~     This prospective study was performed on 82 participants. Severe pain on percussion of the~     relevant tooth was considered as basic criteria when deciding on acute infection phase. The~     acutely infected teeth were labeled as the study group (n=35) and the asymptomatic ones as~     the control group (n=47). The extractions were done in the usual way. Amount of anesthetic~     solution used and durations of extractions were recorded.~   "
6204|NCT03485651|"~     The purpose of this study is to collect blood, tissue, and health information from~     individuals with adnexal masses to develop a blood test to detect ovarian cancer.~   "
6205|NCT03485638|"~     1. Background Cetuximab (trade name Erbitux) is a murine-human chimeric monoclonal antibody~          to human epidermal growth factor receptor (EGFR). This drug has been used as a treatment~          for colorectal cancer and head and neck cancer. It is known that allergic reactions can~          occur in more than 5% of the patients, although the side effects are relatively low~          compared with other chemotherapeutic agents. It is known that cetuximab can induce~          hypersensitivity even at the first administration, unlike other anticancer drugs. In~          this study, we aimed to establish a model to predict patients with hypersensitivity~          reaction before administration of cetuximab and to provide safe chemotherapy.~        2. Recruitment method and consent procedure The study is designed for analysis patients~          scheduled for administration of cetuximab for the first time. Patients matching the~          selection and exclusion criteria with voluntary agreement to the study will be enrolled.~          Enrolled patients will be tested for skin prick test and serum sIgE before cetuximab~          administration.~   "
6206|NCT03485625|"~     The study was planned to compare the effect of ketorolac 20 mg to 300 mg of paracetamol when~     added to lidocaine 3 mg/kg for Intravenous regional anaesthesia.~   "
6207|NCT03485612|"~     The assessment of the diameter of the optic nerve sheath (ONSD) using ultrasound can be a~     very helpful tool in the assessment of increased intracranial pressure in patients operated~     for urological procedures.~   "
6208|NCT03485599|"~     Human immunodeficiency virus infection is a global pandemic problem. About 35.3 million~     infected people in the world, so causing a great social, economical, political and cultural~     problems worldwide.~      In 1986 Egypt's first AIDS case was discovered , since then the number of infected cases~     cases are increasing.According to United Nations 2016 statistics, there are about 11,000~     infected people living with Human immunodeficiency virus in Egypt.~   "
6210|NCT03485573|"~     Every year more people die from traumatic injuries than from infections such as malaria,~     tuberculosis, and HIV/AIDS. About 3000 people are killed annually on Kenyan roads. Hospital~     trauma registers have played a key role in the advancement of patient-based research and~     trauma care. Trauma registers offer a unique opportunity to document patient characteristics~     and audit outcomes, thereby creating a platform for clinical research. One of these systems~     is the ICD-based Injury Severity Score (ICISS) derived from and validated on hospital data to~     predict hospital death. The establishment of the register enables us to compare the trauma~     care quality with other existing or upcoming trauma registers, in different settings.~   "
6211|NCT03485560|"~     Chronic skin disease lead to skin damage and disfiguring to the patient skin. Sometimes,~     achieving normal skin is not possible by the normal traditional treatment, this study is~     focusing on use of ACE CSD formula which is mixture of natural peptides and herbs. the main~     aim is to restore the normal skin appearance for the patient and control the episodes of~     flare.~   "
6212|NCT03485547|"~     This research study is studying a drug as a possible treatment for BPDCN.~      The intervention involved in this study is: Venetoclax~   "
6213|NCT03485534|"~     This study evaluates the efficacy and safety of switching to Tenofovir Disoproxil from~     Tenofovir Disoproxil Fumarate in Chronic Hepatitis B Patients who pretreated with Tenofovir~     Disoproxil Fumarate.~      In Open-Label, phase 3 studies, we randomly assigned patients with hepatitis B e antigen~     (HBeAg)-negative or HBeAg-positive chronic HBV infection to receive Tenofovir Disoproxil or~     Tenofovir Disoproxil Fumarate (ratio, 2:1) once daily for 48 weeks~   "
6214|NCT03485521|"~     The aim of this study is to compare a control group (Practical Work Group) with a High~     fidelity Stimulation group about competences and reasoning clinic.~   "
6215|NCT03485508|"~     Although for many years the Brugada syndrome has been labelled as a purely electrical disease~     in the structurally normal heart, the evolution of imaging techniques has enabled the~     discovery of subtle morphofunctional alterations in some of the Brugada syndrome patients. We~     will use new echocardiographic techniques to assess cardiac function in these patients and~     new parameters will be evaluated for their prognostic value as risk stratificators.~   "
6216|NCT03485495|"~     The purpose of this study is to obtain further data on the efficacy and safety of Divaza~     therapy for oxidative impairment elimination in patients with cerebral atherosclerosis.~      It is assumed that the inclusion of the drug Divaza in the basic therapy will help reduce the~     severity of cognitive disorders, other clinical symptoms of cerebral atherosclerosis, reduce~     the impact of the disease on the quality of life of the patient.~      Participate in the study may be patients with a diagnosis of cerebral atherosclerosis,~     which, against the backdrop of basic therapy with constant doses of drugs (within the last 4~     weeks), to achieve a stable course of cerebral atherosclerosis, cognitive disorders without~     significant disability are detected.~   "
6217|NCT03485482|"~     The purpose of the study was to investigate the potential interaction between ivabradine and~     bisoprolol in healthy subjects.~   "
6218|NCT03485469|"~     The therapeutic problem of obesity is weight control, a major difficulty, involving a~     significant change in eating behavior. A number of studies show that there are many factors~     of resistance to weight loss whether they are physiological, genetic, environmental pressure~     related, or psychological and behavioral. For some patients, the surgical approach seems the~     best alternative. Indeed, bariatric surgery is an effective therapeutic weapon in patients~     with morbid obesity. However, it has been shown that approximately 25% of patients are~     failing at two years of this surgery (Reinhold's index). Some of the failed subjects may~     benefit from surgical revision. As for the others, no intervention is currently proposed to~     them. Studies have shown that the psychological profile of patients who are candidates for~     bariatric surgery is predominantly immature, impulsive, very anxious with a tendency to~     depression. The stress level of these patients would be important, and they would have low~     self-esteem. This study hypothesize that, in these patients, the establishment of~     hypnotherapeutic management associated with the usual dietary monitoring could modify eating~     habits thus promoting weight loss and an improvement in self-esteem , stress and anxiety~     compared to dietary monitoring alone.~      There are still no studies assessing the impact of hypnotherapeutic management and~     self-hypnosis on the weight curve, self-esteem, stress, anxiety, or the quality of life of~     patients Obese in failure of bariatric surgery.~   "
6219|NCT03485456|"~     The goal is to investigate the pharmacokinetic properties of dry powder tobramycin via the~     Cyclops® at different dosages in children with cystic fibrosis, together with the local~     tolerability.~   "
6220|NCT03485443|"~     Otorhinolaryngological surgery is one of the commonly applied procedures surgical treatments~     of children in the world. Postoperative vomiting (POV) is an important part of the management~     of pediatric anesthesia in this surgery that is also related with these surgical procedures.~     Postoperative vomiting is one of the most common complication of this surgery and may cause~     patients to receiving anesthesia again and stay longer in the hospital.The use of effective~     fluid therapy might be a safe way to reduce POV. There are many studies of fluid therapy~     adult patients on the other hands the number of children studies are limited.~      The aim of this study was to evaluate the POV effect of intraoperative hydration with 0.9~     NaCl solution in children undergoing otorhinolaryngological surgery.~   "
6221|NCT03485430|"~     This randomized controlled study compares tapering of long-term opioid therapy in a~     population with chronic non-cancer pain with control group constituted of waiting list. Half~     of participants receives intervention at baseline and the other half are controls but~     receives intervention after 4 months.~   "
6222|NCT03485417|"~     In Hong Kong, less than 5% of stimulants abusers were reported to misuse these substances via~     injection. Also, it is well known that patients with co-morbid substance abuse/dependence and~     psychosis or schizophrenia-related disorders are prone to earlier treatment discontinuation~     and high oral medication non-adherence, resulting in poorer overall outcomes. With the recent~     availabilities of the 4-weekly long-acting injectable form of aripiprazole, and the 4-weekly~     and the 3-monthly long-acting injectable form of paliperidone palmitate, on the background of~     the surging phenomenon of stimulant misuses in Hong Kong, it is a timely opportunity to~     conduct an early pharmacotherapy intervention study to offer an evidence-based strategy~     aiming to stop individuals with substance use disorders with psychosis to develop into a more~     chronic disabling dependence or co-morbid state.~   "
6223|NCT03485404|"~     This study will recruit patients more than 65 years old eligible for non-cardiac surgery.~     Patients who participate will take either vitamin B12 and folic acid supplementation or~     placebo for 7 days before surgery. Neuropsychological test battery (NPB) will be tested~     before intervention and at discharge for determination of Post operative cognitive~     dysfunction (POCD). Another group of non-surgical elderly participants will also be tested~     for NPB to account for learning effect in POCD diagnosis. The hypothesis is that preoperative~     vitamin B12 supplementation will reduce the incidence of POCD in elderly patients undergoing~     non-cardiac surgery.~   "
6224|NCT03485391|"~     Veterans who have prematurely dropped out of exposure therapy for PTSD will be contacted and~     offered the opportunity to return to treatment, this time with the assistance of an in vivo~     exposure therapy 'workout buddy'. This peer will meet them at the in vivo exposure therapy~     location and offer support an encouragement while the patient remains in that location. As~     the PTSD treatment standards in Charleston and other VA sites across the country increasingly~     include telemedicine delivered care, both in person and telemedicine based exposure therapy~     recipients will be included. There will be no randomization; all participants will receive~     the peer support 'workout buddy' for exposure therapy assignments.~   "
6225|NCT03485378|"~     This is a prospective phase II study of Stereotactic Ablative Radiotherapy (SABR) in patients~     with Non-Small Cell Lung Cancer (NSCLC) and co-existent Interstitial Lung Disease (ILD), to~     determine oncologic and toxicity outcomes. Patients will be divided into 3 separate cohorts~     based on the ILD-GAP index.~   "
6226|NCT03485365|"~     This study is the first administration of GSK3858279 to humans. The purpose of this study to~     evaluate safety, tolerability, PK, target engagement and potential for efficacy of single~     intravenous (IV) and subcutaneous (SC) doses of GSK3858279 in healthy volunteers and subjects~     with osteoarthritis of the knee. The primary objective of the study is to evaluate the safety~     and tolerability of escalating doses of GSK3858279 in following single IV and single SC~     dosing in healthy volunteers in Part A. Single IV doses and a single SC dose will be~     investigated in separate cohorts of subjects in Part A. Part B will investigate the safety,~     tolerability, PK and target engagement in blood and potential for efficacy on pain of~     subjects with OA of the knee after a single IV dose. Subjects will be randomized in 3:1 ratio~     to receive GSK3858279 and placebo in sequential manner in Part A. In Part B, subjects will be~     randomized in parallel groups to receive either GSK3858279 or placebo. Approximately 48~     healthy subjects will be enrolled amongst 6 cohorts in Part A and up to a maximum of 50~     subjects will be enrolled in Part B of the study. The total study duration will be~     approximately 140 days for Part A and Part B.~   "
6227|NCT03485352|"~     The present study has a prospective, longitudinal and observational character, will be~     performed with patients attending a private clinic specialized in the treatment of obesity~     and bariatric surgery. Patients to be analyzed should have a medical indication for bariatric~     surgery.~   "
6228|NCT03485339|"~     Evidence suggests that repeated or chronic ketamine use, as compared to acute ketamine users,~     posed a higher clinical risk of developing psychotic disorders, potentially related to the~     underlying chronic N-methyl-D-aspartate receptor (NMDAR) dysfunction, and a higher risk of~     suffering from schizophrenia particularly in those genetically susceptible, or genetically~     predisposed ketamine abusers. With ketamine infusion rises as a emerging hope as an acute~     treatment for depression and suicidality under the shadow of unknown longer term~     psychotomimetic effects peculiarly amongst repeated or chronic use, the current case-control~     study aims to investigate: a) if repeated or chronic ketamine use is associated with an~     increased risk of psychosis by comparing those ketamine abusers with and without psychosis,~     and to those non-ketamine-using drug abusers with psychosis; and b) if genetic predisposition~     from single nucleotide polymorphisms are associated with risk of psychosis in ketamine~     abusers.~   "
6229|NCT03485326|"~     This is a multi-center, prospective, non-interventional study. The study will enroll about~     1700 Chinese patients diagnosed as NSCLC and treated with osimertinib at least one dose.~      The objective of this non-interventional study is to monitor the safety profile of~     osimertinib in Chinese NSCLC patients in real world clinical practice.~   "
6230|NCT03485313|"~     Prospective, single-centre study to determine the reference range (95th percentile) of human~     chorionic gonadotropin (hCG) levels in a healthy, non-pregnant, adult female population using~     the RAMP® Total β-hCG test.~   "
6231|NCT03485300|"~     The aim of the study is to identify the prevalence of warfarin resistance among patients of~     prosthetic cardiac valves although it is given with normally therapeutic prescribed doses and~     the identification of the causes of its resistance.~   "
6232|NCT03485287|"~     This multi-site, open-label, Phase 2, lead-in study assesses the safety and effect of~     3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in participants diagnosed~     with at least severe posttraumatic stress disorder (PTSD). Therapy teams that have been~     identified and trained to work on the sponsor's planned Phase 3 studies will treat at least~     one open-label participant in this study. The study will be conducted in up to N=5~     participants. A flexible dose of MDMA, followed by a supplemental half-dose unless~     contraindicated, is administered during the Treatment Period with manualized psychotherapy in~     three open-label monthly Experimental Sessions. This ~12-week Treatment Period is preceded by~     three Preparatory Sessions. During the Treatment Period, each Experimental Session is~     followed by three Integrative Sessions of non-drug psychotherapy. The Primary Outcome~     measure, the change in Clinician Administered PTSD Scale for DSM 5 (CAPS-5) from Baseline.~     Exploratory measures will address specific symptoms, such as sleep quality, or behavior that~     is sometimes related to PTSD. Drug safety will be assessed by measuring blood pressure, heart~     rate and body temperature during experimental sessions, collecting adverse events and~     measuring suicidal thoughts or behaviors with the Columbia Suicide Severity Rating Scale~     (CSSRS). This study will compare the effects of three open-label manualized Experimental~     Sessions of psychotherapy assisted by flexible doses of MDMA. Initial doses per Experimental~     Session include 100 mg or 125 mg of MDMA compounded with lactose, followed 1.5 to 2 hours~     later by a supplemental half-dose (50 mg or 62.5 mg). Total amounts of MDMA to be~     administered per Experimental Session range from 100 mg to 187.5 mg.~   "
6601|NCT03480438|"~     The trial proposed here attempts to reduce induction chemotherapy to phase I of standard~     induction in patients with B-precursor ALL. Induction phase II will be replaced by~     blinatumomab.~      The initial treatment phase is followed by sequential chemotherapy and further blinatumomab~     cycles.~   "
6234|NCT03485261|"~     A myriad of sexual problems affect men and women with chronic kidney disease (CKD), including~     decreased libido, erectile dysfunction, dysmenorrhea, and infertility. Menstrual~     abnormalities are common in CKD and many women are an-ovulatory.~      Sexual dysfunction in CKD is multifactorial including hormonal alterations along with~     vascular, neurologic, psychogenic, and other factors, such as medications, contribute to the~     development of sexual dysfunction. Sexual dysfunction in females is mainly due to hormonal~     factors and manifests mainly as menstrual irregularities, amenorrhea, lack of vaginal~     lubrication, and failure to conceive.~   "
6235|NCT03485248|"~     Administration of antiretroviral therapy has brought benefits to people living with HIV /~     AIDS, reducing the number of AIDS-related morbidity and mortality. However, it is responsible~     for intensifying complications triggered by the chronic inflammatory state associated with~     virus infection, such as cardiovascular diseases, and changes in muscle mass which may~     compromise the strength of these individuals. Beet juice (BJ) was shown to be effective in~     improving these physiological parameters in uninfected individuals. The present study is~     evaluating the effects of ingestion of 140ml beet juice on endothelial function, oxygenation~     and muscle performance in people living with HIV / AIDS who use antiretroviral treatment.~   "
6236|NCT03485235|"~     Effect of dilatation and curettage on the endometrial receptivity and pregnancy outcome in~     patients with recurrent implantation failure~   "
6237|NCT03485222|"~     Purpose:~      The overall hypothesis of the study is that the benefits attained in the EMPA-OUTCOME were,~     at least in part, mediated by a glucose-independent mechanism. Thus, to demonstrate the~     existence of the postulated non-glucose dependent effects, the researchers will investigate~     the safety and efficacy of empagliflozin versus placebo on top of guideline-directed medical~     therapy in heart failure patients with reduced ejection fraction without diabetes.~   "
6238|NCT03485209|"~     This trial will study tisotumab vedotin to find out whether it is an effective treatment for~     certain solid tumors and what side effects (unwanted effects) may occur. The treatment will~     be given to patients every three weeks.~   "
6239|NCT03485196|"~     The relationship between Microsatellite instability and efficacy of fluorouracil based~     adjuvant chemotherapy in gastric cancer after operation.~   "
6240|NCT03485183|"~     The purpose of this study is to determine if using an over-the-counter, commercially~     available sleep noise machine playing pink or white noise will reduce the incidence of~     delirium in hospitalized patients over the age of 65. Delirium is an acute change in~     cognition which commonly occurs in hospitalized older adults, and is linked with sleep-wake~     cycle disturbance. Delirium is associated with increased morbidity and mortality as well as~     longer hospital stays. This project will record delirium screening scores for those receiving~     the intervention and comparing them to baseline data. Reducing delirium rates using a~     noninvasive, inexpensive method in a hospital setting could have a significant impact on~     patient outcomes and potentially reduce costs associated with longer hospital stays. It is~     anticipated that white/pink noise played at night will decrease rates of delirium in~     hospitalized older adults.~   "
6241|NCT03485170|"~     Repeated hemarthroses in patients with hemophilia may lead to hemophilic arthropathy with~     marked inflammation and synovial hypertrophy. Power Doppler ultrasonography is a useful tool~     in hemophilic arthropathy for assessment of disease activity and for monitoring response to~     treatment. Imaging inflammation with glucose analogue fluorine-18-fluorodeoxyglucose positron~     emission tomography (18F-FDG PET) is based on that infiltrated granulocytes and tissue~     macrophages use glucose as an energy source. Metabolism and 18F-FDG uptake increase when~     inflammation occurring. The purpose of this study is to investigate the associations between~     18F-FDG PET/CT and Power Doppler assessment in patients with hemophilic arthropathy.~   "
6242|NCT03485157|"~     The purpose of this study is to determine the safety and effectiveness of micronized~     dehydrated human amnion chorion membrane as compared to the 0.9% Sodium Chloride Injection,~     USP placebo control for the treatment of knee osteoarthritis~   "
6243|NCT03485144|"~     The goal of this study is to determine the immunogenicity and safety of TV003(TetraVax-DV), a~     live attenuated tetravalent dengue vaccine candidate, in healthy human subjects in Taiwan~   "
6244|NCT03485131|"~     This is a 4 week therapeutic pilot study with a 4 week follow-up period involving inpatients~     with treatment resistant DSM-IV schizophrenia or schizoaffective disorder diagnosis. Each~     eligible subject will receive either 20 minutes of active tDCS (transcranial direct-current~     stimulation) or sham stimulation twice a day on 5 consecutive weekdays for 4 weeks with a 4~     week follow-up period.~   "
6245|NCT03485118|"~     Primary objective:~      To evaluate the efficacy of recombinant human-mouse chimeric anti-CD20 monoclonal antibody~     injection(HS006) with CHOP(Hi-CHOP) versus Rituximab with CHOP (R-CHOP) in patients with~     previously untreated Diffuse Large B-cell Lymphoma as first line treatment.~      Secondary objective:~      To evaluate the safety of recombinant human-mouse chimeric anti-CD20 monoclonal antibody~     injection(HS006) with CHOP(Hi-CHOP) in patients with previously untreated Diffuse Large~     B-cell Lymphoma.~      To study the pharmacokinetics of recombinant human-mouse chimeric anti-CD20 monoclonal~     antibody injection(HS006) in patients with previously untreated Diffuse Large B-cell~     Lymphoma.~   "
6255|NCT03484988|"~     The findings of previous experiments suggested that polyunsaturated fatty acids(PUFAs) has~     been linked to anti-hyperlipidemia, and reducing the risk of cardiovascular disease.This is a~     randomized double-blind trial, aims to study the effect of PUFAs on blood lipids and human~     metabolism. Firstly, the investigators will investigate the efficacy of mixed plant~     oil(echium oil, camelina oil, safflower oil) and pure echium oil on improving the levels of~     blood lipids. Secondly, next generation sequencing (NGS), ultra-high performance liquid~     chromatography-tandem mass spectrometric (UPLC-MS/MS) and gas chromatography-mass~     spectrometry detection will be conducted to explore the role of PUFAs on gut microbiota as~     well as metabolites. Thirdly, single nucleotide polymorphism will be genotyped by~     Time-of-flight mass spectrometry to find the gene-environment interaction effect.~   "
6256|NCT03484962|"~     This is a phase II Randomized comparison clinical trial of activated CIK armed with~     anti-CD3-MUC1 bispecific antibody for advanced liver cancer. And the aim of this research is~     to study the clinical efficacy and safety of activated CIK armed with anti-CD3-MUC1~     bispecific antibody for liver cancer.~   "
34556|NCT03114241|"~     Long-term evaluation of a coaching program which helps patients with severe COPD to increase~     their daily step count, in addition to usual care.~   "
6246|NCT03485105|"~     To conduct a retrospective study to prove a hypothesis of adjuvant chemotherapy provides~     survival benefit for patients of CTX-benefit group in gastric cancer of pT1N1, especially in~     high-risk group. This study is a pilot study and the result will be used as a reference for~     the upcoming prospective randomized controlled trial for same issue including estimating~     sample size. Two high-volume hospitals (Yonsei University Severance Hospital and Samsung~     Hospital) will participant this pilot study.~      FFPE sample blocks and clinical information pertaining to the patients who satisfied with~     selection criteria will be collected from two institutions. The primary end point of this~     study is disease-free survival (DFS) that is defined as the time from surgery to death or~     gastric cancer recurrence whichever occurred first; and overall survival (OS) that is defined~     as time from surgery to death by any causes. Clinical information such as age, sex,~     histology, Lauren classification, depth of invasion, number of retrieved and metastatic lymph~     nodes, sizes of tumor, location of tumor, gross type, lympho-vascular invasion, received~     chemotherapy or not will be centralized.~      One or 2 of 3mm core of tumor will be punched from FFPE and it will be delivered through~     Eppendorf tube to laboratory (Novomics Co. Ltd., Seoul, Korea). RNA will be extracted from~     the tissue and the pattern of RNA expression will be evaluated and each sample will be~     categorized into three risk group (high, intermediate, low risk group) and two predictive~     group (CTX-benefit and no-benefit group) by GMP-grade nProfiler 1TM Stomach Cancer Assay Kit~     (Novomics Co. Ltd., Seoul, Korea). Both clinical information and classification will be~     delivered to independent statisticians who are responsible to conduct statistical analyses.~   "
6247|NCT03485092|"~     The investigators hypothesise that empagliflozin 10mg daily will have haemodynamic, cardiac,~     and renal benefits compared to placebo over 36 weeks in heart failure patients with type 2~     diabetes, leading to measurable improvements in clinical measures of cardiac structure and~     function (LVESVI, and LV strain) as well as renal blood flow.~   "
6248|NCT03485079|"~     This study is a prospective, multicenter, cohort study. The study will be completed in three~     phases.~      The first phase aims to establish SCD PW marker and PW score scoring system~        1. Use big data processing techniques to find out the differences between survivors with~          ventricular arrhythmias and normal controls. Find out the SCD Pre-warning ECG Marker (PW~          marker).~        2. Establish SCD Pre-warning risk score system according to traditional SCD risk factors,~          clinical characteristics of patients and abnormal electrocardiogram indicators.~        3. According to the established SCD PW marker and PW score scoring system, the original~          group of patients are classified and scored. After five years of follow-up with~          sustained ventricular tachycardia or ventricular fibrillation as the primary end point~          and sudden cardiac death as the secondary endpoint, Kaplan-Meier are used to calculate~          the mortality rate of sudden cardiac death and Kaplan-Meier survival analysis. The COX~          proportional hazards regression model is used to further determine and evaluate the SCD~          predictive value of PW marker and PW score risk factor scoring system.~      The second phase is to validate the established PW marker and PW score system models and~     evaluate the SCD predictive value of it. This stage is divided into two parts:~        1. Patients enrolled in traditional high-risk ventricular arrhythmia, will be divided into~          PW marker positive group and PW marker negative group and join in a 5-year follow-up.~          Kaplan-Meier is used to calculate the mortality rate of sudden cardiac death and~          Kaplan-Meier survival analysis is performed to further verify the early warning effect~          of PW marker on SCD.~        2. Patients will be divide into three groups including the low-risk group, middle-risk~          group and high-risk group according to the PW score risk factor scoring system and join~          in a 5-year follow-up. Kaplan-Meier is used to calculate the mortality rate of sudden~          cardiac death, and Kaplan-Meier survival analysis is used to further verify the early~          warning effect of PW score scoring system on SCD.~      The third stage is the development stage of SCD early warning equipment. This stage will~     conduct clinical translational medical studies of PW marker and PW score based on the~     previous study and develop PW marker and PW score as portable SCD warning device and/or~     mobile phone APP which will be applied to the clinic for early warning diagnosis of SCD.~   "
6249|NCT03485066|"~     Background: Neuronal plasticity is the brain's ability to continuously adapt to experiences~     and learning of new skills. Although this affects multiple characteristics of the brain such~     as structure, function and metabolism, direct interactions between these aspects are largely~     missing.~      Aim: Using recent advancements in neuroimaging we aim to identify novel relationships how~     neuronal plasticity is related across these characteristics.~      Design: 40 healthy subjects will undergo two simultaneous PET/MR measurements at baseline and~     after 4 weeks. During the measurements a cognitively challenging task will be performed and~     the training group (20 subjects) will practice during the 4-week period.~      Implications: We combine simultaneous PET/MR and novel task-specific PET imaging to study~     brain metabolism, structure and function in a single measurement session. This provides~     optimal sensitivity for assessment of multimodal neuroplasticity associations. Knowledge how~     cognitive training affects multiple characteristics of the brain will also increase our~     understanding of disorders like depression, dementia and brain injuries, since these are~     diagnosed with cognitive evaluations. Considering the vast usage of the applied imaging~     procedures in diagnosis and therapy monitoring, the thorough investigation of multimodal~     associations offers benefit for the interpretability of neuroimaging in clinical routine.~   "
6250|NCT03485053|"~     The purpose is to evaluate the efficacy and safety of IOP Injection for the treatment of~     iron-deficient anemia (IDA).~   "
6251|NCT03485040|"~     SMaHRT (Stroke Motor reHabilitation and Recovery sTudy) is a longitudinal study aimed at~     understanding the natural history of upper extremity motor recovery after ischemic stroke.~   "
6252|NCT03485027|"~     This is a single-arm, open-label, single-center prospective phase II study to evaluate the~     efficacy and safety of rechallenge chemotherapy in the third or later-line treatment in~     patients with advanced colorectal cancer. The primary end point is progression free survival~     (PFS). A total of 42 patients who failed with oxaliplatin, irinotecan and fluorouracil in~     previous treatment and could not receive the target therapy presently are planned for~     recruitment. For patients with metastatic colorectal cancer who met admission criteria,~     oxaliplatin- or irinotecan-based chemo regimen could be used and evaluation was repeated~     every 6 weeks. The treatment continues until the disease progression or the untolerable~     adverse reaction.~   "
6253|NCT03485014|"~     Primary objective: The primary objective of this study is to evaluate the pharmacokinetics~     (PK) of EXPAREL in pediatric subjects 12 to less than 17 years of age undergoing spinal~     surgery.~      Secondary objective: The secondary objective of this study is to evaluate the safety of~     EXPAREL in pediatric subjects 12 to less than 17 years of age undergoing spinal surgery.~   "
6254|NCT03485001|"~     Introduction: Pterygium is a wing shape degenerative and hyperplastic growth of the bulbar~     conjunctiva extending onto the cornea, most commonly on the nasal side. Management of~     pterygium can be medical, surgical or combined. Alternative treatments as photocoagulation of~     blood vessels of the pterygium, have been described, especially in recurrent pterygia.~      Objectives: To determine whether Argon laser treatment reduces the symptoms and pterygium~     size in primary type I pterygia patients when compared with medical treatment. Subjects and~     Methods: Prospective, comparative and interventional study. Patients with type I pterygia in~     both eyes were included. The eyes were randomly divided to receive either Argon laser~     treatment or only topical medical treatment~   "
6257|NCT03484949|"~     Gastric cancer is one of the most common malignancies in China. Early detection is critical~     for gastric cancer management. However, the diagnosis rate of patients with early gastric~     cancer is still low. Therefore, the investigator design this study to access whether~     pre-endoscopic screening risk assessment of genetic and environmental risk factors could~     improve early gastric cancer diagnosis rate.~   "
6258|NCT03484936|"~     The purpose of this study is to determine whether treatment with remote ischemic conditioning~     is of sufficient promise to improve outcome before conducting a larger clinical trial to~     examine its effectiveness as a treatment for intracerebral hemorrhage.~   "
6259|NCT03484923|"~     The primary purpose of this study is to evaluate the efficacy of novel spartalizumab (PDR001)~     combinations in previously treated unresectable or metastatic melanoma~   "
6260|NCT03484910|"~     Osteoarthritis (OA) is one of the most common joint diseases causing pain, muscle weakness~     and disability in older population. Quadriceps muscle weakness is one of the recognized risk~     factors for the development and the progression of the disease. Increasing the muscle~     strength could actually bring many benefits to the knee OA patients. The purposes of this~     study are 1) to investigate the effects of combining the EMG biofeedback technique into a~     stationary cycling exercise on the activities of vastus medialis (VM) in people with medial~     compartment knee OA; 2) To investigate the efficiency of a 6-week cycling exercise program on~     improving of quadriceps muscle strength and endurance, physical functions and pain in these~     patients and compare between the conditions of with or without EMG biofeedback; 3) To~     determine the relationships between the muscle activities and the kinematics of the knee~     joint during this cycling exercise program; and therefore to find the mechanism of the~     improvement on muscle activities in the intervention of cycling combining EMG biofeedback. In~     this study, we will enroll the knee OA patients from our hospital, and they will be randomly~     assigned either to the control group, who will cycle without biofeedback, or the biofeedback~     group, who will cycle with a real-time visual EMG biofeedback, during the six-week training~     program. The exercise program consisted of a 5-minute warm-up with low-resistance cycling,~     30-minute moderate-resistance cycling exercise, and 5-minute cool down session. . The knee~     adduction angle, quadriceps strength and endurance, KOOS Chinese version, VAS scale will also~     be measured at baseline and after six weeks of intervention. Mixed-model repeated measure~     analysis of variance (ANOVA) will be used to determine if there are any differences in the~     kinematic, myoelectric, muscle strength and endurance. It is hoped that the results of this~     study could provide information regarding the proper and efficient training strategy for the~     OA knee patients, and deliver the concepts of proper exercise technique to enhance health in~     the community.~   "
6261|NCT03484897|"~     Open clinical study to evaluate the soothing activity of a body cream to be applied once a~     day, mono-laterally at level of the antecubital fold and forearm, for an uninterrupted period~     of 1 month, by 22 adult volunteers, with positive anamnesis for atopy and habitual itching.~   "
6262|NCT03484884|"~     The purpose of this study is to test Cerenkov luminescence imaging, which is a different way~     to take pictures of thyroid cancer and/or any tumors with (existing or suspected) nodal~     metastases in the neck, supraclavicular, axillary and/or inguinal region.~   "
6263|NCT03484871|"~     The purpose of this study is to determine whether reduced frequency of migraine attacks are~     associated with signal alternation and connectivity of cerebral cortex.~   "
6264|NCT03484858|"~     The aim of the current study is to determine the effect of sprint interval training (SIT) in~     conjunction with either high or low glycaemic index meals (breakfast, lunch and dinner) on~     the 24-hour glycaemic profile and glucoregulatory hormones in Asian males.~   "
6265|NCT03484845|"~     This study will conducted to evaluate and comparison between the effectiveness, safety and~     acceptability of lactoferrin alone, ferrous fumarate alone and combination of both for the~     treatment of mild to moderate IDA during pregnancy.~   "
6266|NCT03484832|"~     All participants are randomly allocated to the spray group, EMLA group and placebo group. In~     spray group, participants receive an application of placebo cream at the needle electrode~     insertion site 60 minutes before needle insertion, and a self adhering dressing is placed~     over the site. After 60 minutes, the dressing and cream are removed from the site, then the~     insertion site is sprayed from a distance of 30 cm for 5 seconds or until the skin was~     blanched, then intra-articular injection of shoulder is performed. Immediately after~     injection, participants are asked to fill out the visual analog scale for injectional pain,~     five point Likert scale for satisfaction about the topical anesthesia. In EMLA group,~     participants receive an EMLA cream and placebo spray. In placebo group, participants receive~     a placebo cream and placebo spray.~   "
6267|NCT03484819|"~     This phase II trial studies how well copanlisib and nivolumab work in treating participants~     with diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma that has come~     back or does not responded to the treatment. Copanlisib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as~     nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving~     copanlisib and nivolumab may work better in treating participants with diffuse large B-cell~     lymphoma or primary mediastinal large B-cell lymphoma.~   "
6268|NCT03484806|"~     This is a observational、multicenter, prospective cohort study for adults with significant~     VHD. The purposes of this study were to evaluate the etiology、clinical~     characteristics、treatment modalities, and outcomes of patients with VHD；also to set up~     registration system of adult VHD in China, to build a database of Chinese adult VHD, to~     establish a web-based international standard data acquisition system for VHD and a~     multicenter clinical research platform. The results of the study will provide a basis for the~     future national health policy for prevention and treatment of adult VHD.~   "
6269|NCT03484793|"~     Medication errors are common, life-threatening, costly but preventable. Information~     technology and automated systems are highly efficient for preventing medication errors and~     therefore widely employed in hospital settings. In this study, investigators would perform a~     cluster randomized controlled trial of a clinical reminding system that uses DNN and~     Probabilistic models to detect and notify physicians of inappropriate prescriptions, giving~     them the opportunity to correct these gaps and increase prescriptions completeness. This~     study aim is to assess whether or not this system would improve prescription notation for a~     broad array of patient conditions.~   "
6270|NCT03484780|"~     This is a pilot for evaluating the benefits and risks of chronically delivering Asymptomatic~     Diaphragmatic Stimulation in medical refractory heart failure patients using the VisONE™~     implantable system for 12 months.~   "
6271|NCT03484767|"~     Longitudinal, exploratory, natural history study of patients with MMA due to mut deficiency~     to characterize the changes in blood disease biomarkers over time and the frequency and~     severity of clinical events related to their disease.~   "
6272|NCT03484754|"~     The aim of the study is to evaluate in adult subjects with resistant depression the effect of~     an injection of botulinum toxin in the corrugator and procerus muscles, in comparison to the~     infiltration of the crow's feet area, in addition to the current antidepressant treatment.~   "
6275|NCT03484715|"~     Older people living in nursing homes spend the majority of their time inactive. The current~     study has designed a physical activity intervention for older people living in nursing homes~     whereby the participants will incorporate more physical activity throughout their daily~     activities. Each participant's physical activity programme will be tailored to their physical~     abilities and to a pre-defined goal. The aim of this pilot feasibility study is to explore~     the feasibility and acceptability of this physical activity programme and to examine the~     preliminary effects of this on physical mobility and health-related quality of life, when~     compared to a usual care control group.~   "
6276|NCT03484702|"~     Phase 2 single-arm, multi-cohort study to determine the efficacy and safety of JCAR017~     (autologous T cells expressing anti-CD19 chimeric antigen receptor) in adult subjects with~     aggressive B-NHL (diffuse large B-cell lymphoma (DLBCL) NOS [de novo or transformed~     follicular lymphoma (tFL)], double/triple-hit lymphoma [DHL/THL], follicular lymphoma Grade~     3B [FL3B], primary central nervous system lymphoma [PCNSL] and Richter's transformation).~   "
6277|NCT03484689|"~     Background: Diabetes-related distress (DRD) is very common among people with type II diabetes~     mellitus (DM). DRD led to poorer DM control and may led to adverse prognosis. Yet, there is~     no widely accepted or recommended DRD treatment.~      Mindfulness was shown to relieve psychological distress in various physical and mental~     conditions.~      Aim: as a pilot project, we aim to determine if mindfulness-based cognitive therapy (MBCT),~     which is one of the widely used mindfulness program, is feasible and acceptable and may~     improve DRD in our Chinese population.~      Method: 20 Chinese participants with suboptimally controlled DM and high DRD will be~     recruited to a 8- week MBCT group. Pre-group and post-group (immediate and 2-month~     post-group) data including DRD score, quality-of life measures will be compared.~   "
6278|NCT03484676|"~     Patients with unilateral non-comminuted zygomatic complex fracture undergo fixation of the~     complex by a customized plate at one point after 3D virtual simulation and reduction of the~     complex using Mimics software.~   "
6279|NCT03484663|"~     Small catheter drainage with chest tube after uniport Video-assisted Thoracoscopic Procedures~   "
6280|NCT03484650|"~     Ventral hernia repair leads to more than expected pain. This is thought to be secondary to~     nerve pain at the lateral transfixion sutures. Systemic lidocaine given pre-op has in other~     situations decreased neurogenic pain. This study will examine its effects on pain experienced~     after ventral hernia repair.~   "
6281|NCT03484637|"~     This study evaluates patient response to a motivation evolution chart for a medical-nutrition~     intervention as a continuation of a previous study: adherence to an overweight and obesity~     treatment available at: https://www.ncbi.nlm.nih.gov/pubmed/25101227~   "
6282|NCT03484624|"~     The purpose of this study was to investigate the changes in muscle fatigue and respiratory~     metabolic energy expenditure during walking with wearable hip-assist robot (V3).~   "
6283|NCT03484611|"~     A multicentric study looked into 179 poor responders who underwent antagonist protocol in~     ICSI cycles Gonadotrophines is started on day 2 with HMG until the day of HCG administration~     with starting dose 300IU to 450IU,with no pretreatment with OCPs or progestogens or estrogen.~      GNRH antagonist (cetrorelix 0,25mg s.c, cetrotide, serono laboratories, Aubonne Switzerland)~     is given using flexible protocol, it is given when at least one follicle reaches size 14 mm~     to prevent premature lutenization ,until the day of hCG administration Ovarian ultrasound~     scans were performed using a 5.0-9.0 MHZ multi frequency trans vaginal probe to assess the~     ovarian response till the mature follicles reach18-20mm when hCG administration 10000 IU is~     given to induce final oocytes maturation , serum E2 is done on day of HCG trigger.~      Trans vaginal ultrasound-guided oocyte retrieval is performed 34-36 hours after hCG~     injection.~      Ultrasound -guided fresh embryo transfer is performed on day 3 or 5 after fertilization.~      Progesterone support of luteal phase was commenced on the day of ovum pick up using~     prontogest 400 mg twice daily.~   "
6284|NCT03484598|"~     The primary objective is to collect preliminary data related to the clinical utility of the~     SPEAC System in patients with a history of motor seizures. This trial is primarily an~     observational investigation. This protocol describes a series of observational case studies.~     Each case study is intended to be interpreted independent from the other case studies.~     Self-reported seizure frequency will be compared to observed seizure frequency using the~     SPEAC System.~   "
6285|NCT03484585|"~     The objective of this study is to determine the mass balance and routes of excretion of total~     radioactivity after a single oral 200 mg dose of [14C]rogaratinib given as a solution. For~     further clinical development, human mass balance data are required to elucidate the~     absorption, distribution, metabolism, and excretion (ADME) of rogaratinib.~   "
6286|NCT03484572|"~     To describe the prevalence of undernutrition in infants and children admitted to Assiut~     university children hospital and to describe risk group and decrease length of stay in~     hospital.~   "
6287|NCT03484559|"~     Define the frequency and survival pattern of cardiac arrests in relation to the hospital day~     of event and etiology of arrest.~   "
6288|NCT03484546|"~     This study evaluates the optimum day of menstrual period for the excision of endometriomas to~     minimize the damage of surgery to normal ovarian tissue. Patients will be grouped as~     follicular, ovulatory and luteal according to menstrual days. Ovarian damage will be~     evaluated with both pathologic examination and anti-mullerian hormone levels before and after~     the surgery.~   "
6320|NCT03484117|"~     A randomized trial to test the feasibility and acceptability of an intervention to improve~     retention in HIV primary care in HIV-infected Hispanic immigrants compared to a treatment as~     usual condition. We will measure feasibility, acceptability, study retention, and effect~     sizes of outcomes in order to inform a larger trial. The intervention design is based on~     qualitative research with HIV-infected Hispanic immigrants and their HIV providers. The~     intervention will be led by a Spanish-speaking community health worker trained in HIV health~     promotion.~   "
6328|NCT03484013|"~     Purpose of the study is the evaluation of the applicability of the percutaneous technique~     through double Proglide and Pre-Close Technique to the treatment of complex aortic aneurysms~     with thoracic endoprosthesis (TEVAR), fenestrated or branched (F / B-EVAR) in which~     patient-related factors, the devices used or the procedure, could affect the performance.~   "
29290|NCT03183622|"~     This is an open-label follow up study to evaluate the safety for the subjects with~     ALLO-ASC-DFU treatment in phase 1 clinical trial(ALLO-ASC-BI-101) for 23 months.~   "
6289|NCT03484533|"~     The investigators will conduct a randomized trial to evaluate whether provision of oral HIV~     self-test kits (HIVST) to HIV-positive pregnant women to provide to their male partner,~     increases the proportion of male partners who test and link to HIV care or prevention,~     compared to invitation letters for fast track testing. Pregnant women who are randomized to~     the arm with secondary distribution of HIVST to their male partners will be trained in the~     use and interpretation of HIVST, and given two oral fluid-based HIVST kits to use with or~     give to their partners, along with information about HIV testing and prevention and care~     services. The investigators will offer men confirmatory testing regardless of their HIVST~     result, counseling, and if negative, pre-exposure prophylaxis (PrEP) and if positive,~     antiretroviral therapy (ART). The investigators will provide counseling to minimize social~     harms of HIV self-testing, and additional counseling and referral to social support services~     when social harms occur. This project will address key challenges in PMTCT B+ programs, by~     evaluating innovative strategies to increase male partner's knowledge of their HIV status,~     disclosure, and involvement coupled with offering PrEP to HIV-negative men, ART to~     HIV-positive men, and encouraging post-partum ART continuation and adherence among~     HIV-positive women.~   "
6290|NCT03484520|"~     An open-label, dose-escalation study to assess safety, pharmacokinetics and efficacy as well~     as determine the recommended Phase 2 doses of co-administered therapy of dinaciclib and~     venetoclax for patients with relapsed or refractory Acute Myeloid Leukemia (R/R AML).~   "
6291|NCT03484507|"~     This is a study of optimal treatments for acanthamoeba keratitis. In the first part of the~     study, participants will be randomized to chlorhexidine monotherapy or chlorhexidine plus~     povidone iodine. After four weeks of therapy, participants will be re-randomized to early~     corticosteroids, later corticosteroids, or placebo.~   "
6292|NCT03484494|"~     The protocol involves functional Magnetic Resonance Imaging and Magnetic Resonance~     Spectroscopy acquisitions immediately before and after Low Field Magnetic Stimulation~     treatment on two separate days in a sham controlled, randomized trial, in order to assess the~     physiologic effects of Low Field Magnetic Stimulation on brain function in a geriatric~     population with bipolar depression.~   "
6293|NCT03484481|"~     Introduction: Protein energy malnutrition is one of the strongest predictors of morbidity and~     mortality in maintenance hemodialysis (MHD) patients. Many reports indicate that there is a~     high prevalence of malnutrition up to 40% , and has a strong association with inflammation~     and cardiovascular disease (CVD) as well as lower quality of life in this population. The aim~     of this study was to compare the nutritional modalities by means of biochemical parameters,~     arterial stiffness and bioimpedance analysis.~      Material and Methods: We designed an observational study with 56 malnourished MHD patients~     (mean age: 61.8±12.3 years, duration of hemodialysis: 7.9±5.1 years) . Patients were~     distributed into 4 groups according to patients requests for nutritional support modalities.~     We offered the combination of oral nutritional support (ONS) and intradialytic parenteral~     nutrition (IDPN) to all patients however some of the patients refused this combination thus~     we had 4 groups as; Group 1 (patients received only ONS and refused parenteral nutrition; n:~     14), group 2 (patients received only parenteral NS and refused ONS; n: 14), group 3 (patients~     received both oral and parenteral NS; n: 10) and group 4 (dietetic support group; patients~     who refused all types of nutritional support and only followed by counselling, n: 18) for 12~     months. Biochemical parameters were assessed from monthly clinical visits. Normalized protein~     catabolic rate (nPCR), malnutrition-inflammation score (MIS), body composition (fat mass~     [FM], fat-free mass (FFM) muscle mass (MM, body mass index (BMI)) by multifrequency~     bioimpedance analysis (BCM, Fresenius).~   "
6294|NCT03484468|"~     Since the cornea is the main responsible for the refraction of the eye, as its refractive~     power is greater than 70% of the total refraction of the eye, so modification of its~     refractive properties are used to change the optical system of the eye. Hence, laser-assisted~     in situ keratomileusis has become the most commonly procedure used to correct the refractive~     errors of the eye. The most important step in laser-assisted in situ keratomileusis is the~     creation of the corneal flap, which its thickness may judge the whole outcome of the surgery~     . So trying to minimize the variation in the thickness of the resultant flap in comparison to~     what planned flap thickness preoperatively become our target.~   "
6295|NCT03484442|"~     Acute mesenteric ischemia is a life-threatening condition with high mortality. Acute~     mesenteric ischemia is responsible for fewer than one in 1000 hospital admissions, but its~     mortality rate ranges between 30% and 90% . Acute mesenteric ischemia is most commonly~     secondary to embolism followed by arterial thrombosis, non-occlusive ischemia, and less~     commonly venous thrombosis . Delay in diagnosis contributes to the continued high mortality~     rate. Early diagnosis and prompt effective treatment are essential to Correspondence to~     improve clinical outcomes~   "
6296|NCT03484429|"~     Limb loss is frequently associated with postamputation pain that can be challenging to treat~     and often involves opioids. Advances in the field of neuromodulation has led to development~     of an intentionally reversible percutaneous peripheral nerve stimulation (PNS) system that~     has had promising results when treating chronic postamputation pain. PNS may offer sustained~     pain relief even after the treatment period has ended. Currently, there is no convincing~     evidence regarding the role of PNS in the acute postoperative period, which may be a critical~     time to control pain as those with higher pain appear to be at higher risk for developing~     persistent post-procedural pain. The investigators of this study aim to evaluate the~     feasibility and effects of PNS in the acute postoperative period and determine the~     feasibility of completing a randomized controlled treatment outcome study.~   "
6297|NCT03484416|"~     The present study investigated the effect of routine calcium and vitamin D supplementation~     and tried to find the predictors for postoperative hypocalcemia in patients with thyroid~     cancer.~   "
6321|NCT03484104|"~     Selective antegrade cerebral perfusion (sACP) during aortic arch surgery in hypothermic~     circulatory arrest (HCA) is an established method for intraoperative neuroprotection.~     Although sACP is established as a beneficial method to reduce secondary neurological side~     effects due to brain-malperfusion, there are several parameters like sACP flow rate,~     perfusion pressure or temperature of the perfusate, where the optimal values remain unclear.~     The flow rate of the sACP-perfusate is increased according to center-specific~     standard-procedures. The optimal sACP flow rate, monitored by near infrared spectroscopy~     (NIRS), is to be investigated in this single center clinical prospective observational study.~     40 Patients are enrolled over an estimated period of 14 months.~   "
6298|NCT03484403|"~     The main objectives of this study are to evaluate the benefits of back bracing in the~     symptomatic management of patients with CLBP due to degenerative lumbar disc disease. The~     plan is to study patients with uncomplicated CLBP without symptoms of radiculopathy or~     neurogenic claudication.~      The secondary objectives of the study are to evaluate if a back brace provides any additive~     benefit to usual care consisting of exercise and patient education in patients with CLBP due~     to degenerative disc disease.~      Specific Aim 1. To evaluate the effectiveness of back brace to improve pain and~     patient-reported functional measures in patients with uncomplicated CLBP due to degenerative~     disc and degenerative joint disease without associated symptoms of neurogenic claudication or~     lumbosacral radiculopathy.~      Hypothesis 1. Back brace in addition to usual care will provide statistically significant~     improvement in pain and functional measures compared to usual care alone.~      Specific Aim 2. To evaluate the adherence to back brace wear instructions in patients with~     uncomplicated CLBP due to degenerative disc and degenerative joint disease without associated~     symptoms of neurogenic claudication or lumbosacral radiculopathy Hypothesis 2. Patients with~     CLBP, due to degenerative disc and degenerative joint disease without associated symptoms of~     neurogenic claudication or lumbosacral radiculopathy, who are prescribed a back brace, will~     demonstrate clinically acceptable rates of adherence to brace wear instructions.~   "
6299|NCT03484390|"~     The purpose of this randomized control trial is to examine the effects of a Mindfulness-Based~     Stress Reduction (MBSR) program on women with posttraumatic stress disorder related to~     intimate partner violence.~   "
6300|NCT03484377|"~     This study aims to use concurrent Transcranial Direct Current Stimulation (tDCS) and~     Magnetoencephalography (MEG) with measures of impulsivity to examine the neurobiological~     underpinnings of rapid response impulsivity (RRI) and how these can be modified using tDCS in~     healthy subjects.~   "
6301|NCT03484364|"~     Our Specific Aims are:~        1. At the individual level, to compare within-person change in BP and secondary outcomes~          between the intervention and control groups.~        2. At the family level, to evaluate ENACTS' effects on BP and secondary outcomes as~          within-person change in family members who provide primary support, and as mean change~          in other adult family members who are not directly engaged in the intervention.~        3. At the policy level, to evaluate the intervention's ability to influence grocery store~          policy on clearly identifying foods that are low in sodium or high in potassium, some of~          which might not be easily identified with existing labels (e.g., fresh produce). ENACTS~          combines empirically supported elements of existing programs, thus increasing its~          probability of success. It aligns with the American Heart Association's call for~          multilevel prevention.~   "
6302|NCT03484351|"~     Between 45-73% of people who have had a stroke fall over in the months and years following~     their stroke. Falls not only lead to injuries such as broken hips, but they may also lead to~     fear of falling. As a consequence people can get fearful to walk, keep up their household~     tasks and their social activities such as visiting friends and family.~      Research has shown that exercises for strength and balance can help both older people and~     patients after stroke to get fitter and healthier and help to prevent them from having a~     fall. People also have less falls if they have learned about falls facts and home safety~     precautions. Research has further suggested that people have less fear of falling and less~     injuries from a fall if they have learned how to fall ('safe landing' strategies). Based on~     these research findings the researchers have developed a new falls prevention programme~     called the Fall Monty Activity Programme (FallMAP). This programme aims to aid in functional~     recovery and reduce falls by combining a mix of activities such as falls education, strength~     and balance exercises, and activities that teach people how to get up from the floor and how~     to fall safely.~      Especially because people with residual impairments following a stroke have an increased risk~     of a fall, the feasibility of this programme will be tested in a small group of people after~     stroke first. This study is a first step in establishing whether the different components of~     the FallMAP are acceptable and practical for both patients after stroke and staff who deliver~     the program. In particular, it is important to evaluate if it is feasible to provide the~     seven combined components as one comprehensive programme. Secondly, the question whether~     participating in the programme can positively influence the participants' fear of falling,~     quality of life, leg strength, balance and mobility will be explored. If this feasibility~     study suggests the programme can work in the clinical setting, then a definitive randomised~     controlled trial will be proposed in order to look at whether the full programme is effective~     at reducing falls in patients after stroke.~   "
6303|NCT03484338|"~     This study will examine whether accelerated resolution therapy (ART) is effective for the~     treatment of prolonged and complicated grief and associated psychological trauma among older~     adult hospice caregivers who have experienced the death of an immediate family member at~     least 12 months ago.~   "
6304|NCT03484325|"~     The purpose of this study is to follow the patient's short term and long term clinical~     outcome after undergoing joint replacement surgery.~   "
6305|NCT03484312|"~     Previous studies have reported a high prevalence of hypertensive (HT) urgency. However, these~     studies have also reported low rates of serious complications, suggesting that rapid blood~     pressure (BP) reduction may be unnecessary. There are limited clinical data available on this~     topic in Asian populations. The investigators aimed to determine the basic characteristics,~     treatment methods, and outcomes in HT urgency patients, both in the emergency room (ER) and~     at a two-week follow-up.~   "
6306|NCT03484299|"~     Compare the efficacy and tolerability of IRE in combination with either FOLFIRINOX or~     gemcitabine in patients with locally advanced pancreatic cancer.~   "
6307|NCT03484286|"~     A novel tool for self-care enhancement for heart failure (HF) patients has been developed. In~     this randomized controlled trial, patients will be randomized 1:1 to either receive the~     home-based tool (OPTILOGG) or standard care. The intervention will go on for 8 months, and~     outcomes are self-care, quality of life, cardiovascular events (including emergency visits,~     admissions and number of in-hospital days).~   "
6322|NCT03484091|"~     We compare the efficacy of intra-articular injection of Hyruan-One with Hylan G-F 20 and~     placebo (NSS) controlled in a double-blind RCT.~   "
6323|NCT03484078|"~     The aim of the 6-month randomized controlled trial, with 6-month no treatment follow-up, is~     to examine the effects of low-magnitude vibration on muscle, physical activity, and balance~     in children with spastic cerebral palsy.~   "
6324|NCT03484065|"~     The aim of this observational study is to evaluate the quality of life in patients with~     congenital afibrinogenemia using the Haemo-QoL SF for kids and the Haem-A-QoL for adult~     patients.~   "
6325|NCT03484052|"~     Interventional study with minimal risks and constraints, prospective, monocentric.~   "
6326|NCT03484039|"~     The purpose of this study is to incorporate multidimensional self-management programs into~     the routine care of epilepsy patients. Consenting patients will enroll in one of four~     interventions that help improve medication adherence, increase seizure awareness and~     documentation, improve memory and deal with stress and depression.~   "
6308|NCT03484273|"~     When an individual with Postural Tachycardia Syndrome (POTS) stands up, their heart rate~     increases significantly (>30BPM) and they may experience symptoms such as lightheadedness,~     dizziness, shortness of breath, nausea and mental confusion.~      One commonly prescribed treatment for POTS is compression garments. Compression garments~     squeeze veins to help return blood back to the heart, which may decrease heart rate and~     symptoms on standing. However, there is little research about the effectiveness of~     compression in adults with POTS.~      In this study, the investigators will use the Lifewrap garment, which compresses the abdomen,~     pelvis and lower extremities, to evaluate the effectiveness of compression in POTS. The~     investigators will use a head up tilt (HUT) which will simulate standing. The study~     participant will participate in 4x 10 minute HUTs wearing 4 different compression~     configurations:~        1. full abdomen and lower extremity compression~        2. abdominal only compression~        3. leg only compression~        4. No compression~      The investigators hypothesize that with full compression, the participant's heart rate~     increase from lying down to upright will be lower than when they are not wearing any~     compression. The investigators will also ask the participant about their symptoms when they~     are upright.~      The results of this study could demonstrate the potential benefits of compression and what~     configuration is most effective. These findings could rapidly translate to the clinical~     setting, providing improved care.~   "
6309|NCT03484260|"~     We will investigate if testosterone is preferentially given to patients at higher risk of~     cardiovascular events. If this is the case, then observational studies may be prone to~     selection bias resulting in overestimation of the cardiovascular risk associated with~     testosterone when compared to a healthier population not taking testosterone~   "
6310|NCT03484247|"~     In upper extremity surgery, brachial plexus block (BPB) is routinely applied successfully as~     general anesthesia (GA). However, BPB is less invasive technique than GA. Peripheral nerve~     blocks have some potential benefits, such as lower risk of nausea and vomiting, early~     ambulation, early discharge, and better control of postoperative pain. The BPB is applied to~     various areas such as axillary, supraclavicular, infraclavicular and interscalene areas under~     the guidance of ultrasound and nerve stimulator. Among these methods, BPB administration~     success rates are around 95-100%. The other condition is anesthetic time which is important~     for the turnover of operating room. Anesthetic time is the sum of the performance time and~     onset time. In addition performance time and number of needle attempts also associated with~     patient satisfaction. The primary aim of this study is to determine the number of attempts~     and the performance time with the onset time and anesthetic time. If the procedure is simple,~     the performance time may be shorter. Therefore, the investigators aim that comparison of two~     different procedures which are single injection infraclavicular brachial plexus block and~     multiple injection axillary brachial plexus block by ultrasound guidance. In addition, the~     investigators will examine the duration of anesthesia and surgery, the duration of sensory~     and motor block endings, patient comfort and pain scales in the postoperative period.~   "
6311|NCT03484234|"~     This study compares angiographic and clinical outcomes in patients with long coronary lesions~     treated with sirolimus-eluting stent (Ultimaster stent) or everolimus-eluting stent (Xience~     Alpine stent). The study uses a randomized, multicenter, controlled design approach.~   "
6312|NCT03484221|"~     To evaluate the efficacy and safety of totally neoadjuvant FOLFOXIRI chemotherapy~     (irinotecan, oxaliplatin and fluorouracil) followed by short-course radiation therapy and~     XELOX chemotherapy in the patients with locally advanced rectal cancer.~   "
6313|NCT03484208|"~     The St JOSEPH'S HOSPITAL set up a fracture liaison service for osteopotic fracture. A~     specific nurse screens eligible patient admitted in emergency yard and call them to propose a~     bone densitometry and a medical coverage..~      The aim of the study is to evaluate this new organisation~   "
6314|NCT03484195|"~     To evaluate the efficacy and safety of neoadjuvant FOLFOXIRI chemotherapy (irinotecan,~     oxaliplatin and fluorouracil) in the patients with locally advanced colon cancer.~   "
6315|NCT03484182|"~     Stroke is the leading cause of disability worldwide. Of the annual incidence of stroke~     (~750,000) in the USA about 60% fail to recover arm and hand use contributing to reduced~     quality of life for survivors and caregivers. How can therapists facilitate the~     rehabilitation of individuals with arm movement deficits and increase their quality of life~     over a long time period? It is known that principles of treatment including repetition,~     feedback, challenge and progression are important for producing recovery. The ability for~     patients to train at home and manage their own rehabilitation duration, intensity and~     progression, via effective self-management strategies, is vital. What is needed is an~     effective, easy to use, low cost system that self-motivates patients to intensively practice~     their therapy exercises at home while maintaining elements of repetition, feedback, challenge~     and progression. In this proposal the investigators intend to adapt just such a web-based~     system originally designed in the UK. The first version of the system has shown preliminary~     efficacy and feasibility in a small pilot study in UK. The investigators will adapt the~     system for use in the USA, with the assistance of consultants from the UK.~      The purpose of this study is to investigate the efficacy and feasibility of using a free,~     easy to use, interactive web-based upper extremity stroke rehab program on individuals with~     stroke who have recently been discharged from outpatient rehabilitation. The goal is to~     compare the home use of the web-based stroke rehab program with that of written exercises in~     a randomized controlled trial. The aims/objectives are to (1) adapt the existing system for~     use in America including adding bilateral activities and then to assess (2) motor function~     immediately before and after six weeks intervention and after twenty weeks follow up in order~     to support the efficacy of using this web-based intervention; (3) behavioral changes in~     motivation and self-efficacy at the same time points to understand the relationship between~     behavioral and motor function changes; (4) perceptions of patients and caregivers of the~     web-based program to understand feasibility and barriers to home use; and (5) perceptions of~     therapists to understand feasibility and barriers to clinic use.~   "
6316|NCT03484169|"~     Specific patterns of PNF have been used in neurological and rheumatologic rehabilitation to~     improve trunk control and postural stability. However, there are no studies that analyze the~     effect of pelvic PNF patterns on pelvic floor muscles. We hypothesize that pelvic patterns of~     proprioceptive neuromuscular facilitation activate the pelvic floor muscles in healthy~     individuals through the abdomino-pelvic synergism. Thus, the objective of the study is to~     analyze the effects of pelvic patterns PNF on the recruitment of pelvic floor muscles in~     healthy individuals.~   "
6317|NCT03484156|"~     The study aim is to assess the capacity of a technological solution for analyzing older~     person's functional and cognitive autonomy at home. Results from this study will also be used~     to elaborate the design of a further larger national multicenter randomized control trial~     assessing the efficacy of the solution to detect early infra-clinical disability.~   "
6318|NCT03484143|"~     The active Neuro RX Gamma device uses non-invasive near-infrared energy delivered to the~     brain with the intention to improve cognitive functioning and quality of life in patients~     with moderate to severe Alzheimer's Disease. Treatment will occur at home-based treatment~     sessions with the device.~   "
6329|NCT03484000|"~     Background: Chemotherapy treatment (CT) can have burdensome side effects such as fatigue,~     nausea-vomiting, and sleep problems that can significantly affect patients' quality of life.~     Fatigue is the most common, lasting and bothersome of these, which prevents people from~     working and carrying out daily activities. Mindfulness-Based Cancer Recovery (MBCR) is an~     evidence-based group training program which has shown to help treat negative physical and~     psychosocial symptoms in cancer patients. The investigators propose to evaluate a~     pilot-tested online-MBCR program for patients undergoing CT who may be low on energy, time or~     have compromised immunity.~      Objectives: To evaluate the impact of participation in online MBCR during CT on fatigue~     (primary outcome), sleep, pain, nausea/vomiting, mood disturbance, stress symptoms and~     quality of life (secondary outcomes) as well as cognitive function and return to work~     (exploratory outcomes) over the course of treatment.~      Methods: The study design is a randomized wait-list controlled trial, conducted during CT for~     patients with breast or colorectal cancer. Participants will take the 12-week online MBCR~     program at home within 2 weeks of randomization (immediate group) or after CT completion~     (waitlist group). Outcomes will be assessed online at, 1) Baseline, 2) Post-MBCR, 3) Post-CT~     (primary outcome) and 4) 12 months post-baseline.~      Anticipated Findings: MBCR is a promising adjuvant program that could help patients prevent,~     delay or diminish aversive symptoms and side-effects associated with CT, particularly~     fatigue. If helpful, online-MBCR could be made easily available at cancer centers worldwide~     and significantly lessen the burden of cancer treatments.~   "
6330|NCT03483987|"~     HCV infection is treated with oral drugs, termed as 'direct-acting anti-viral agents' (DAAs).~     In India, four DAAs are available (sofosbuvir [SOF], daclatasvir [DCV], ledipasvir [LDV] and~     velpatasvir [VEL]). Globally, DAA based regimens have obtained excellent rates of cure. Cure~     of HCV infection is defined as undetectable HCV RNA 12 weeks after stopping drugs, also~     referred to as sustained virological response at week 12 (SVR12).~      Using these DAA based treatment regimens, a small number (up to 5%) of people fail to achieve~     SVR12 and HCV RNA reappear after a few weeks of stopping the drugs (virological relapse).~     Data on management of virological relapse are extremely limited, especially in genotype 3,~     and no guidelines exist regarding re-treatment options for such group. Hence, we plan to~     re-treat such people using what appear to be the best combination treatment in each situation~     and to review our experience over time.~      Participants with chronic HCV infection who relapsed following standard DAA-based treatment~     regimen will be invited to participate. We propose to re-treat them with the anti-HCV drug~     combination which appears to be the most suited to his/her clinical profile, based on the~     current empiric knowledge - the choice of drugs will be based on HCV genotype, the previous~     treatment regimen and the presence/absence of liver cirrhosis, etc.~      During anti-HCV treatment, participants will be given expected standard of care and HCV RNA~     will be tested at 4-week intervals starting from week 4 and till RNA becomes undetectable,~     and then at the end of treatment and 12 weeks after the treatment was stopped - as is the~     usual practice during such treatment. Relevant clinical, laboratory and treatment details~     will be recorded in a pre-defined data collection form. Treatment outcome will be categorized~     as success (SVR12), treatment failure (any detectable HCV RNA at the end of 24 weeks~     treatment duration) or relapse (HCV RNA negative at the end of treatment, but positive at 12~     weeks after stopping treatment).~      If possible, a 5-ml blood specimen will be collected before starting re-treatment from all~     participants; in addition, another similar specimen will be collected following the treatment~     in those in whom the re-treatment is unsuccessful. These will be stored and may be used in~     future for virological studies to look for drug-resistance variations.~   "
6331|NCT03483974|"~     Background Information With the advance in cancer biology, we realize that malignant neoplasm~     is related with different biological patterns in metabolome and microbiota. Because of the~     progress in optical spectrometry, it has become possible to evaluate whole visible and~     innon-visiable absorptive spectrum in human specimens, which may enable detection of minor~     changes in compound related with altered metabolome and microbiota. We hope to utilize~     hyperspectral imagingthis spectrum technology to reveal the possible clues of neoplasm for~     early stage detection~      Material and Methods This research intended to enroll one hundred patients into the study.~     This includes patients with positive stool or urine analysis admitted for workup of~     colorectal cancer. We will scan the stool and urine with hyperspectral imaging sensoroptical~     spectrometer, which utilize multichannel charge-coupled device and InGaAs array to analyze~     the full spectrum of light patterns. The image pattern will be stored and used to linked~     final diagnosis. Absorption, scattering, and reflection spectra are expected for analysis.~     Follow up analysis after cancer staging will be used for lowering background noise in all~     spectra.~      Expected Results We expect that there will be specific spectral pattern in stool of~     colorectal cancer patients, which may be related with cancer staging and different from those~     in patients without malignancy. Difference in spectra will lead to discovery of new biomarker~     for colorectal cancer and related diseases. The optic spectra pattern of stool and urine may~     assist early diagnosis and staging of different malignancies~   "
6332|NCT03483961|"~     The goal of this Phase 2 trial is to evaluate the immune response to and safety profile of~     various doses/formulations/and schedules of administration of PXVX0317 in healthy adults.~      Primary Objective:~      To assess the immune response to the vaccine~      Secondary Objectives:~      To assess the kinetics of the immune response to different doses/formulations/schedules To~     assess the persistence of immune responses to different doses/formulations/schedules To~     assess the effect of a booster dose of the vaccine~      Safety Objective:~      To assess local and systemic reactions to the vaccine and to describe the safety profile of~     the vaccine~   "
6333|NCT03483948|"~     This is a Phase I, open-label, non-randomized, multicenter study to evaluate the safety,~     pharmacokinetics and preliminary efficacy of HMPL-523 in combination with Azacitidine in~     previously untreated elderly patients with AML who are not eligible for standard induction~     therapy.~   "
6334|NCT03483935|"~     This is a two-stage feasibility study to determine if focussed microwave energy is a suitable~     treatment for Actinic Keratoses (AK).~      The two study stages are as follows:~      Stage 1:~      To determine the electrical properties of permittivity in AK on the hand and bald scalp for~     subsequent optimisation of the SWIFT instrument to provide the correct dose of microwave~     energy to the AK.~      Stage 2:~        1. Evaluate the efficacy of microwave energy as a treatment for AK~        2. Evaluate the long-term resolution of AK following microwave treatment~        3. Assess the feasibility and acceptability of using microwave energy as a treatment for AK~        4. Identify the potential mode of action of microwave energy in the treatment of AK.~      The primary objective is to evaluate the efficacy of microwave therapy versus no treatment on~     the resolution of AK lesions using visual assessment. The primary outcome measure is greater~     than 25% full or partial resolution of the AK assessed by skin examination.~   "
6353|NCT03483688|"~     This is a single arm, single-center, non-randomized study to evaluate the safety and efficacy~     of C-CAR011 therapy in relapsed or refractory B cell Non-Hodgkin Lymphoma (NHL).~   "
6611|NCT03480308|"~     This study evaluated the analgesic efficacy of fentanyl and dexamethasone in combination with~     bupivacaine for single-shot paravertebral block (PVB) in patients undergoing major breast~     surgery.~   "
6335|NCT03483922|"~     Hepatocellular Carcinoma (HCC) is the fifth most common cancer world-wide. It is particularly~     prevalent in Asia, and its occurrence is highest in areas where hepatitis B is prevalent,~     indicating a possible causal relationship. Follow up of high-risk populations such as chronic~     hepatitis patients and early diagnosis of transitions from chronic hepatitis to HCC would~     improve cure rates. In most cases HCC is detected late resulting in increased mortality and~     morbidity.~      The purpose of this study is to develop and test non-invasive biomarkers based on methylation~     changes in PBMC, T-cells and circulated tumor DNA in hepatocellular carcinomas patients.~   "
6336|NCT03483909|"~     The majority of schizophrenia patients is impaired in hand gesture performance, which~     contributes to poor functional outcome and poor communication skills. The left inferior~     frontal gyrus (IFG) and the left inferior parietal lobe (IPL) are key nodes of the gesture~     network, which is less active in patients with schizophrenia. Here, the investigators test~     single sessions of rTMS/TBS known to either enhance or inhibit local brain activity for app.~     1 hour. The investigators aim to determine, which protocol may improve gesture performance in~     patients and healthy controls. This is a randomized, double-blind, cross-over,~     placebo-controlled single-center trial in 20 patients with schizophrenia spectrum disorders~     and 20 healthy controls. Gesture performance will be tested immediately after each TMS~     session, which are separated by 48 hours. Results of this study will inform larger~     interventional trials comparing 2 TMS protocols with repeated administration.~   "
6337|NCT03483896|"~     This study is designed to test the hypothesis that an intervention increasing exposure to~     daylight indoors will reduce depression and other neuropsychiatric symptoms among people~     living with dementia in long term care facilities.~   "
6338|NCT03483883|"~     To determine the feasibility and safety of avelumab and gemcitabine combination therapy in~     patients with metastatic sRCC.~   "
6339|NCT03483870|"~     Neuraxial anesthesia, which includes epidural anesthesia and intrathecal anesthesia, is a~     frequent anesthetic approach for caesarean delivery and other lower abdominal and lower limb~     anesthetic procedures. The addition of neuraxial morphine to local anesthetics provides an~     effective and prolonged postoperative analgesia. Neuraxial administration of morphine which~     is considered as a gold standard for analgesia has been associated with a frequent incidence~     of pruritus and postoperative nausea and vomiting.~      The incidence of neuraxial opioid induced pruritus varies widely from 30% - 60% after~     orthopedic surgery with intrathecal morphine injection and from 60% - 100% in pregnant women~     after neuraxial opioid administration. Parturients appear to be the most susceptible to~     neuraxial opioid-induced pruritus which probably might be due to the interaction of estrogens~     with opioid receptors.~      Although the exact mechanism of neuraxial opioid induced pruritus is unclear, the postulated~     mechanisms include the presence of an itch center in the central nervous system (CNS),~     medullary dorsal horn activation, antagonism of inhibitory transmitters, modulation of~     5-hydroxytryptamine subtype 3 (5-HT3) or serotonergic pathways and the involvement of~     prostaglandins.~      There is dense concentration of opioid receptors and 5-HT3 receptors in the dorsal part of~     the spinal cord and the nucleus of the spinal tract of the trigeminal nerve in the medulla.~     Activation of these receptors by neuraxial opioid administration or by circulating estrogen~     in parturients results in neuraxial opioid induced pruritus which is usually localized to the~     face, neck, or upper thorax. Nalbuphine, propofol and ondansetron have been used effectively~     in the treatment of pruritus associated with neuraxial morphine in surgical patients.~      Granisetron is a potent and highly selective 5-HT3 receptor antagonist that has little or no~     affinity for other 5-HT receptors, or dopaminergic, adrenergic, benzodiazepine, histaminic,~     or opioid receptors. Its onset of action is 1-3 min, peak plasma level 30 min, plasma~     half-life is 4-6 h and duration of action up to 24 h. Its longer duration of action than that~     of ondansetron may coincide with the peak incidence of pruritus after intrathecal morphine~     (6-9 h). In contrast, other 5-HT3-receptor antagonists have affinities for various~     receptor-binding sites. For example, ondansetron has detectable binding to 5-HT1B, 5-HT1C,~     α1-adrenergic, and μ-opioid receptor sites. Although not proven, the binding of these agents~     to additional receptor subtypes other than their target receptor may underlie the inferior~     adverse event profile seen with ondansetron compared with granisetron.~   "
6340|NCT03483857|"~     This protocol describes the Cohort Assessment phase of an R34 pilot intervention trial of a~     Peer Navigation (PN) intervention tailored to the needs of HIV-positive MSM in rural~     Mpumalanga province South Africa. The PN intervention to be adapted, I-Care, has been~     implemented among HIV-positive men and women in the general population in North West~     province, South Africa, by members of this research team.~   "
6341|NCT03483844|"~     The aim of the study is to evaluate the diagnostic accuracy of low-dose dual energy CT in the~     pre-surgical planning of patients with progression of scoliosis~   "
6342|NCT03483831|"~     Objective: to evaluate hydration status and his impact on cognitive performance in~     adolescents-based cohort study.~      Methods: A randomized controlled pilot study is active in ten classes of one middle school~     (n=214 adolescents aged 12-14; including dismissed students) in an urban area around Milan,~     five classes being assigned to the intervention group and five classes to the control group.~     The five school-months intervention (from January to May 2018) includes changes in class~     environment (water dispenser to refill constantly, re-usable water bottles and educational~     posters about water consumption) and individual reinforcement tools (text messages and school~     lessons). The main endpoint is going to be the hydration status with osmolality urine test~     (dehydration status≥800 mOsm/kg). The secondary endpoint is going to be the correlation~     between the hydration status and cognitive performance (attention, short-term memory and~     concentration) through administration of neuropsychological tests from Neuropsychological~     Assessment Battery for Adolescence (BVN 12-18).~      Results: it is expected an improvement of hydration status in intervention group versus~     control group and positive effects of a correct hydration on cognitive performance.~   "
6343|NCT03483818|"~     DOT-C is a cluster randomised trial of a pharmacist-led, directly observed anti HCV therapy~     pathway versus the conventional care pathway within community pharmacies. The primary trial~     outcome is to evaluate the effect of pharmacist-led anti-HCV directly observed therapy on the~     proportion of patients reaching a sustained virological response.~   "
6344|NCT03483805|"~     Celiac disease (or gluten intolerance) is recognized as one of the most common chronic~     diseases: prevalence of 1 in 100 to 1/300 people in Europe and the United States. To date,~     the treatment consists of a total elimination of any source of gluten from the diet. This~     eviction generates many daily constraints that would explain that more than 50% of patients~     do not follow this diet correctly. Hidden sources of gluten in a number of foods also carry~     the burden of this difficulty in effective exclusion. The objective of the ProtAlSafe study~     is to develop an innovative nutritional approach in the form of a dietary supplement to~     improve quality of life of patients. The product is not intended to replace a strict~     gluten-free diet but to propose a nutritional approach in the form of a dietary supplement to~     improve quality of life of patients. The expected benefits for people consuming the test~     product are an overall improvement in quality of life and an improvement in biological~     markers (intestinal permeability, chronic inflammation, etc.) associated with celiac disease.~   "
10592|NCT03428165|"~     The purpose of the study is to evaluated whether there is a difference in pregnancy rate when~     transferring frozen embryos between patietns having spontaneously ovulated versus those~     triggered to voulate with HCG.~   "
6345|NCT03483792|"~     Polycystic ovary syndrome (PCOS) is the most common cause of ovulation disorders and affects~     10 to 15% of women. Despite its frequency, its physiopathology remains unknown.~      In women, Anti-Müllerian hormone (AMH) is secreted by granulosa cells located in the ovaries~     within the follicles. Compared to control women, serum AMH level is higher in PCOS women and~     could play a role in its pathophysiology. The severity of the PCOS phenotype is correlated~     with the production of AMH.~      It is currently described in the literature that daughters of women with PCOS have a 50% risk~     of developing PCOS, but no genetic cause of transmission is known. In mice (article in~     press), pregnant females injected with AMH give birth to offspring with PCOS symptoms. The~     AMH could thus also play a role in the heritability of PCOS in women. Our team demonstrated~     that AMH, in its active cleaved form, had a direct central action on the hypothalamus by~     increasing the pulsatility of GnRH, inducing LH hypersecretion. The hypothesis is that AMH~     remains higher in pregnant women with PCOS and may affect the fetus by altering fetal and~     maternal hypothalamic secretions or by modifying placental steroid production.~      Leptin has a role in reproduction, through its receptors located at the central~     (hypothalamus) and peripheral (granulosa cells) levels. In excessively high serum~     concentration, as observed in obesity, it would lead to a dysregulation of GnRH secretion, an~     alteration of ovarian steroidogenesis and a dysregulation of folliculogenesis.~      Will be compare leptin levels in first trimester patients with and without PCOS to look for~     possible correlations between AMH and leptin and eliminate possible bias.~   "
6346|NCT03483779|"~     Background~      Coronary heart disease has become a serious challenge to China with its high prevalence and~     mortality. The impaired glucose regulation is prevalent in patients with cardiovascular~     disease. However, there are few drugs that interfere early with impaired glucose regulation.~     Ginkgo biloba extract is not only a commonly used drug for cardiovascular diseases, but also~     has a significant effect in reducing blood sugar. Therefore, this study used a single case~     randomized controlled trial to explore the efficacy of Ginkgo biloba pills in the treatment~     of coronary heart disease patients with impaired glucose regulation.~      Methods~      This is a randomized, double-blind, placebo-controlled, three-period crossover trial for a~     single subject.A total of 12 subjects will be recruited in this trial. The trial is divided~     into three cycles, one cycle has two treatment periods. Ginkgo biloba pills and placebo will~     be randomized during the treatment period. The test period will be lasted 58 weeks and~     subjects will take 48 weeks. Subjects will be selected by the researcher strictly in~     accordance with the inclusion and exclusion criteria.~   "
6347|NCT03483766|"~     Individuals with spinal cord injury (SCI) have significant functional loss and poor quality~     of life. Individuals with cervical SCI are suffering much worse sickness within the SCI~     population. Tetraplegia resulting from cervical SCI bring a formidable emotional, physical,~     and financial burden in our society. Hand function is especially important to people with~     tetraplegia. Hand function is associated with independence in many activities, and~     impairments in upper extremity function can compound difficulties in many other areas, such~     as bowel and bladder management. Thus, it is not surprising that restoring hand function was~     found to be a priority for individuals with tetraplegia.~      Nowadays, magnetic resonance imaging (MRI) plays an essential role in the diagnosis of SCI~     and helps to monitor disease progression and efficacy of therapies. Advanced MRI techniques,~     such as diffusion tensor imaging (DTI) and functional MRI (fMRI), have shown the potential to~     improve the understanding of human spinal cord in healthy and pathological condition, and~     serve as imaging biomarkers to characterize damage degree, monitor the response to treatment,~     and predict the outcome of intervention. Meanwhile, multi-channel EMG (Electromyography)~     recordings can provide a mapping of neuromuscular activities from an electrode-array.~      The application of robotics in upper extremity function restoration of SCI patients has been~     started to help SCI patients to recovery upper extremity function. Combined DTI and fMRI to~     monitor the recovery of upper extremity function of SCI patients, this project will provide a~     tailored-made EMG driven soft-robotic hand prosthesis for tetraplegia individuals. We will~     provide the individuals with neuromuscular rehabilitation to preserve the residual function~     and to enhance the functional recovery. The eventual goal is to further design a useful~     robotic hand for regaining partial daily function to improve the quality of life for those~     individuals with tetraplegia.~   "
6348|NCT03483753|"~     The purpose of the present study is to evaluate the effect of vasopressin compared to~     norepinephrine on the clinical complications of patients with vasospastic shock after~     noncardiac surgeries.~   "
6349|NCT03483740|"~     CTNPT 029 will test the feasibility and acceptability of cognitive remediation group therapy~     in older adults living with HIV who have been diagnosed with HIV-associated neurocognitive~     disorder (HAND). The cognitive remediation therapy will include tablet-based cognitive~     training and mindfulness-based stress reduction sessions.~   "
6350|NCT03483727|"~     Combat casualty care has proven to increase survival rate in military conflict by treating~     without delay the quickest-to-kill wounds. The French militaries are trained to the MARCHE~     RYAN acronym, an algorithm designed to help every soldiers provide simple treatment in order~     to bring the patient to the surgeon alive.~      Our first study (MAX, Lelaidier et al, BJA 2017) clearly showed that the use of a digital~     cognitive aid in the hand of the leader significantly improves the management of anaesthesia~     & intensive care emergencies (malignant hyperthermia, anaphylactic shock, acute toxicity of~     local anaesthetics, severe and symptomatic hyperkalaemia).~      The present study exclusively deals with the management of combat casualties with the same~     digital cognitive aid adapted for MARCHE RYAN algorithm.~   "
6351|NCT03483714|"~     To characterize muscle activity through electromyography (EMG) of the lumbar spine during~     high velocity, low amplitude (HVLA) spinal manipulation according to parameters of~     practitioner contact (location, applied force) in healthy participants and two categories of~     low back pain participants.~   "
6352|NCT03483701|"~     The purpose of this study is to help people with serious mental illness get and keep the job~     they want by improving their thinking skills, using cognitive remediation therapy. For people~     with serious mental illness, the Individual Placement and Support (IPS) Program is an~     effective approach to help people become employed. Despite its general success, still only~     55% of clients find employment. Most of that success occurs in the first three months; after~     six months, the chances of finding competitive work are quite low. Among those who fail to~     find employment with IPS, cognitive dysfunction is often a significant problem. The proposed~     study will target IPS clients who have not found work after 3 months of employment-support~     services: our hypothesis is that, after three months with no success, the addition of~     cognitive remediation to IPS will improve employment rates (compared to those who continue to~     receive IPS alone).~      The proposed randomized controlled trial will use a single-blind study design, focused on IPS~     clients who are slow to (or may never) find employment success. Specifically, the proposed~     study will have two treatment arms: a) cognitive remediation added to continued IPS services,~     and b) continued IPS services alone. The study will collaborate with IPS workers at 11 Mental~     Health and Substance Use (MHSU) clinics to identify clients who are non-responders in the~     first 3 months, and seek their consent to participate in the study. They will be randomized~     to either TAU (continuation with IPS and other standard treatments), or TAU plus cognitive~     remediation. The CRT will consist of computerized cognitive exercise practice, strategy~     coaching, and teaching coping/compensatory strategies for 12 weeks. Clients will be assessed~     at 3-time points: prior to the start of cognitive remediation (baseline), end-point~     (3-month), and 6 months after the endpoint evaluation. Primary outcome measures will include~     success at gaining a competitive job, total hours of competitive employment, and~     neuropsychological measures of cognition.~   "
6355|NCT03483662|"~     The IMPACTS study utilizes an effectiveness-implementation hybrid type 2 design to achieve~     two primary goals simultaneously: 1). to test the effectiveness of a multifaceted~     implementation strategy for intensive BP control among underserved hypertensive patients at~     high risk for CVD, and 2). to assess the acceptability, adoption, feasibility, fidelity, and~     sustainability of the multifaceted implementation strategy in patients, providers, and~     healthcare systems.~   "
6356|NCT03483649|"~     This is a Phase I, randomized, double blind, IV, single dose, 4-arm parallel study to compare~     the PK, and to evaluate the safety, tolerability and immunogenicity of HLX04, US Avastin®, EU~     Avastin®, and CN Avastin® in healthy male subjects.~   "
6357|NCT03483636|"~     This study will be conducted to evaluate the effects on cognitive performance (Power of~     Attention domain) and postural stability of lemborexant in combination with alcohol versus~     lemborexant alone and versus alcohol alone in healthy participants. This study will also~     assess the safety and tolerability of a single oral dose of lemborexant when administered~     alone or in combination with alcohol in healthy participants.~   "
6358|NCT03483623|"~     The purpose of this study is to measure peak skin interface pressures and the total area of~     the body exposed to skin interface pressure above 30 mm Hg at different areas of the body in~     the supine position on two different support surfaces applied to a standard North Atlantic~     Treaty Organization (NATO) litter (NSN: 6530-01-380-7309) and a Raven 90C Litter~     (NSN6530-01-432-5114). The support surfaces are the Warrior Evacuation Litter Pad (WELP) and~     the Dolphin Fluid Immersion Simulation Stretcher System (FIS). These pressure measurements~     along with laser doppler flow and transcutaneous oxygenation readings will allow us to~     determine differences between support surfaces.~   "
6359|NCT03483610|"~     The purpose of this study is to learn methods to encourage women to get recommended cervical~     cancer screening. Cervical cancer screening is an important part of cervical cancer~     prevention. The study team will determine if the patient is currently up-to-date with~     cervical cancer screening recommendations. If the patient is not up-to-date, then they will~     be randomly assigned to one of two interventions. One intervention consists only of referral~     to a women's health care provider to obtain cervical cancer screening. The other intervention~     consists of receiving a total of 3 text messages at 30-day intervals encouraging follow-up~     for cervical cancer screening.~   "
6360|NCT03483597|"~     A questionnaire for this research is designed, which initiated from TSQM-II treatment~     satisfaction questionnaire and based on research launched by rheumatology and immunology~     departments of Chinese 12 public tertiary hospitals distributed directionally by Chinese~     Rheumatism Data Center (CRDC). The research is about treatment satisfaction and its~     influencing factors for Chinese rheumatoid immunologists and rheumatoid arthritis (RA)~     patients as well as their expectations for treating this disease. This research will explore~     the matching degree between treatment satisfaction and expectation about rheumatoid arthritis~     from doctors and patients.~   "
6361|NCT03483584|"~     With the availability of effective anti-retroviral therapy, HIV-infected individuals are~     expected not to die of AIDS and have longer life expectancy. But at the same time,~     HIV-associated non-AIDS (HANA) conditions are becoming more important in their clinical~     management. It is currently uncertain whether patients started on different anti-retroviral~     regimens will have different incidence of HANA conditions.~      This study aims to evaluate the incidence of various HANA conditions in a cohort of newly~     diagnosed HIV-infected individuals in Hong Kong initiating anti-retroviral treatment. The~     incidence of various HANA conditions will be evaluated for those receiving INSTI versus other~     non-INSTI-based regimens.~      The HANA conditions evaluated will include 1. Hypertension 2. Diabetes and insulin resistance~     3. Dyslipidemia 4. Lipodystrophy 5. Metabolic syndrome 6. Osteopenia and osteoporosis 7.~     Vitamin D deficiency 8. Renal impairment and kidney tubular dysfunction and 9. Liver~     fibrosis. Patients will be assessed prior to initiation of anti-retroviral therapy, and 48~     weeks and 96 weeks after initiation of treatment. The incidence of development of each HANA~     condition will be determined and compared between those initiated different anti-retroviral~     regimens.~   "
6362|NCT03483571|"~     This is a short longitudinal preliminary study that aims to describe the dynamics of~     low-density subclinical malaria to support the final study design of a subsequent matched~     cohort study. The primary objective is to assess the dynamics of subclinical malaria detected~     by ultrasensitive PCR over a short duration. The results will be used to guide the design of~     a matched cohort study of subclinical malaria in Myanmar and along its borders with China and~     Bangladesh~   "
6363|NCT03483558|"~     The purpose of this study is to perform dietary intervention studies on a variety of~     vegetables.~   "
6364|NCT03483545|"~     This study proposes to evaluate the effect of adding HP-hMG (Menopur) to follitropin delta in~     a mixed protocol regimen, using an individualized, fixed dose of follitropin delta based on~     the established algorithm, combined with a variable, adjustable dose of Menopur based on body~     weight and ovarian reserve.~   "
6365|NCT03483532|"~     Renal lithiasis affects a wide range of the population, ranging from 4 to 15% according to~     the population sample studied. Among all stones, it is estimated that uric stones account for~     between 10 and 15% of all cases and especially affects men over 50 years, while mixed~     lithiasis of calcium oxalate monohydrate and uric acid affects a 2.5% of all cases. Lithiasis~     generated by uric acid is a highly recurrent pathology, even repeating itself several times~     during the year, and is related to other pathologies such as diabetes and obesity. It is~     evident that the medical problem that lithiasis originates should not be treated only by~     eliminating the calculus formed, through the different surgical techniques available, but~     also that the alterations responsible for its formation should be modified and corrected. If~     these alterations are not modified, the risk of the genesis of new calculations persists.~      The pharmacological treatments used until now to treat uric lithiasis are based on the~     powerful alkalinization of the urine (through the use of citrate or bicarbonate); These~     treatments tend to have a low rate of adherence and, taken long term, can cause the~     development of stones of another composition (eg, Phosphate), which are much more difficult~     to treat.~      There are natural substances, such as theobromine (natural component of cocoa) that has been~     found to have the ability to inhibit the formation of uric acid crystals: this substance has~     been tested in laboratory experiments and therefore would be useful to prevent the formation~     of uric acid stones and / or mixed calcium oxalate monohydrate / uric acid stones.~     Theobromine corresponds to a phytocomponent alkaloid that is found in high concentrations in~     chocolate. The starting hypothesis of this study corresponds to the possible increase in the~     capacity of inhibition of the crystallization of uric acid by urine in subjects who have~     ingested food or food supplements containing cocoa or cocoa extract. Therefore, the~     relationship between the intake of a specific food supplement and the ability to inhibit the~     crystallization of uric acid by the urine will be studied. An increase in the ability to~     inhibit the crystallization of uric acid from urine would be useful to prevent the formation~     of uric acid crystals in urine, which are the origin of uric acid stones or mixed calcium~     oxalate monohydrate / acid uric.~      Currently there is no information on the relationship between the ability to inhibit the~     crystallization of uric acid in the urine due to the intake of certain foods or food~     supplements and the concentration of theobromine in urine and urinary pH. The present study~     is carried out to evaluate the relationship between the intake of a specific food supplement~     and the ability to inhibit the crystallization of uric acid by urine, which would be useful~     to prevent the formation of uric acid stones and / or mixed calculations of calcium oxalate~     monohydrate / uric acid.~      The study will be carried out in two stages. The first will consist in the intake of 1~     capsule of a food supplement based on citrate and plant extract without cocoa extract, twice~     a day for 14 days. The second will consist in the intake of 1 capsule of a food supplement~     based on citrate and plant extract with cocoa extract, twice a day for 14 days. Before the~     start of the study a blood sample will be obtained and on the last day of each stage, the~     patient will be asked to collect the 24-hour urine and another 2-hour morning urine sample.~     Between each stage will be a period of 7 days without receiving any food supplement.~      During the study there will be no risk due to the tests that will be performed, since they~     are among those performed in routine clinical practice. Regarding the possible risks~     associated with the intake of food supplement, to minimize them, any patient with chocolate~     or theobromine allergy, pregnant or lactating women and patients with insufficiency are~     excluded from the study participation. chronic kidney The daily amount of theobromine~     ingested as cocoa extract is similar to a quantity of dark chocolate between 11-25 g. This~     consumption of chocolate can be considered normal within a diet. In fact a piece of 50 g of~     dark chocolate contains between 237 and 519 mg of theobromine and daily many people consume~     more of this amount without presenting side effects to be a food.~   "
6366|NCT03483519|"~     The purpose of this study is to assess the effectiveness of a preoperative muscle training~     program on hip or knee TJA (Total Joint Arthroplasty). It aims to improve hospital discharge~     readiness and functional capacity in both the short and long-term. One of the key factors~     affecting recovery after TJA is how well the patient functions before their surgery. Thus,~     interventions addressing preoperative function are expected to be beneficial.~   "
6367|NCT03483506|"~     The primary objective of this trial is to investigate the absolute bioavailability of BI~     1467335 with an intravenous microdose formulation containing labelled [C-14] BI 1467335 and~     an unlabelled oral tablet formulation of BI 1467335 in healthy male subjects.~      The secondary objective is the evaluation of additional pharmacokinetic parameters following~     the two treatments.~   "
6368|NCT03483493|"~     Online Remote Behavioural Intervention for Tics (ORBIT).~      Primary objective: to evaluate the clinical effectiveness of BiP Tic, a therapist-guided,~     parent-assisted, internet-based behavioural therapy intervention for tics in young people,~     compared with usual care plus online education.~      Secondary objectives include 1) optimising the design of the intervention, 2) undertaking an~     internal pilot, 3) evaluating cost effectiveness and 4) longer term impact, and 5)~     identifying barriers to implementation.~   "
30632|NCT03166085|"~     The purpose of this study is to decide the best dose of the study drug, PU-H71, that can be~     given in combination with the standard chemotherapy drug, nab-paclitaxel (Abraxane).~   "
6369|NCT03483480|"~     Pilonidal Disease is disease of young patients with significant morbidity and is difficult to~     treat. Currently multiple methods are practiced for the treatment of the disease, two of them~     are preferred over others and practice extensively. First one involves excision of pilonidal~     sinus and dressings while the second one is excision of the pilonidal sinus with application~     of negative pressure wound therapy. None of these approaches is considered superior to the~     other, as not enough comparison studies of the two procedures have been done. In order to~     clarify this and find the best option for our patients, investigators are taking opportunity~     to compare these two modalities. If participants choose to participate in this study they~     will be randomly selected to one of these groups and the progress of wound healing will be~     monitored after surgery with the measurement of wound weekly and photographs. Investigators~     are hoping to find out which procedure is superior. This will allow investigators to provide~     the best treatment option for their patients in future.~   "
6370|NCT03483467|"~     The Omnigen Pilot study aims to provide an evidence base for Omnigen as a treatment for~     Diabetic Foot Ulcers (DFU). It aims to achieve this by tailoring a regenerative therapy used~     for ocular surface repair to provide proactive non-surgical wound management of Diabetic Foot~     Ulcers (DFU).~   "
6371|NCT03483454|"~     This study observes fitness level and health parameters in children ages 6-12 years old with~     obesity using an exercise class intervention.~   "
6372|NCT03483441|"~     The purpose of this research is to evaluate the use of Photodynamic Therapy (PDT) to treat~     the multiple basal cell carcinoma (BCC) skin cancers in children and adults with Basal Cell~     Nevus Syndrome (or who have at least 3 BCC tumors present). In addition, the investigators~     will test a hypothesis (based upon our extensive preclinical studies in mice) that induction~     of a transient spike in serum Vitamin D levels through administration of dietary Vitamin D~     (cholecalciferol; D3) can significantly increase PDT efficacy and improve the clearance of~     cutaneous BCC tumors.~   "
6373|NCT03483428|"~     Despite being more likely than typical hearing children to experience disruptive behavior~     problems, children who are deaf and hard of hearing (DHH) rarely receive behavioral~     interventions to prevent the long-term costly outcomes of behavior problems. This pilot~     project will systematically adapt an evidence-based behavioral parent training (BPT)~     intervention to increase its acceptability and relevance for parents of young DHH children.~     Two parents of DHH children will be trained in the adapted BPT for DHH children. They will~     each deliver the intervention to five families with DHH preschool-aged children.~   "
6374|NCT03483415|"~     Video-assisted thoracoscopic surgery (VATS) provides an opportunity to penetrate the thoracic~     cavity by video through an incision into the chest wall and facilitate surgical operation of~     lung pathologies.Various regional methods of anesthesia are currently being used to achieve~     this goal.~      The aim of the study was to assess the effectiveness of Long thoracic nerve bloc on~     postoperative VATS analgesia.~   "
6375|NCT03483402|"~     This study aims to evaluate the effect of a single session of micropulse laser~     trabeculoplasty (MLT) on cornea in eyes with primary open glaucoma (POAG) and~     pseudoexfoliation glaucoma (PEXG).~   "
6376|NCT03483389|"~     This study investigates how alcohol affects the immune system and behavior in healthy adults.~     The study also will examine how an individual's typical drinking habits may affect the immune~     system's response to alcohol.~   "
6377|NCT03483376|"~     In today's society cosmetic dentistry plays an important role in social relationships and in~     important aspects of life such as job applications and recruitment processes.~      Currently, the only available treatment option for patients suffering from black dental~     pigmentation of bacterial origin is repetitive professional dental cleanings every two or~     three months, which involve a significant financial outlay, and have been found to be~     psychologically detrimental due to the lack of a perceived cure.~      These pigmentations are of unknown etiology, although there has been reported the presence of~     black-pigment producing bacteria, such as Porphyromonas gingivalis, Tannerella forsythia and~     Aggregatibacter actinomycetemcomitans in such black plaque. These bacteria are found in a~     group known as periodontopathogens, bacteria responsible for the appearance of periodontitis,~     an oral chronic disease with high prevalence.~      In this context, photodynamic therapy, which uses the application of diode light with a~     wavelength between 400-500 nm for the elimination of periodontal pathogenic bacteria, has~     demonstrated effectiveness and absence of adverse effects on the management of patients with~     periodontitis.~      The proposed study seeks to evaluate the effect of photodynamic therapy on teeth with~     extrinsic black pigment, in order achieve an eradication of the stains. The investigators~     will also proceed to analyze in depth the bacterial composition of these stains before the~     application of photodynamic therapy, in order to stablish the aetiological agents of this~     black plaque.~   "
6378|NCT03483363|"~     The purpose of this study is to evaluate the use of topical antibiotic irrigation~     (bacitracin) and its ability to reduce surgical site infections in midfacial fracture surgery~     compared to sterile normal saline (NS).~   "
6379|NCT03483350|"~     Postoperative nausea and vomiting (PONV) is one of the most common complications of general~     anesthesia in pediatrics. Pediatric rates of nausea and vomiting are approximately double~     those of adult patients.~      The physiology of PONV is complex and not perfectly understood. According to our current~     model, the brain structures involved in the pathophysiology of vomiting are distributed~     throughout the medulla oblongata of the brainstem, not centralized in an anatomically defined~     'vomiting centre. Such structures include the chemoreceptor trigger zone (CRTZ), located at~     the caudal end of the fourth ventricle in the area postrema, and the nucleus tractus~     solitarius (NTS), located in the area postrema and lower pons.~   "
6380|NCT03483337|"~     Magnetic resonance imaging (MRI) is a diagnostic technique that takes pictures of organs of~     the body. It uses magnetic fields and radio waves that cannot be felt. This makes specific~     organs, blood vessels, or tumors easier to see. Diffusion MRI lets us measure the motion of~     water in the tumor.~      The purpose of this study is to see if new MRI methods can give us more information about the~     tumor.~   "
6381|NCT03483324|"~     A phase 1b, open label, multi-center trial of AB-110 in adults with hematologic malignancies,~     including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and~     myelodysplasia (MDS) undergoing cord blood transplantation. Subjects will receive~     unmanipulated cord blood (UCB) and AB-110 expanded CD34 enriched hematopoietic progenitor~     cells (HSPC).~   "
6383|NCT03483298|"~     The primary objective of this study is to determine if there is a difference in in vitro~     fertilization (IVF) with intracytoplasmic sperm injection (ICSI) outcomes when using~     testicular sperm versus ejaculated sperm in couples with elevated sperm DNA fragmentation~     after a failed in vitro fertilization (IVF) cycle~   "
6384|NCT03483285|"~     Endotracheal intubation increased the heart rate and blood pressure in normal patients. Open~     heart surgery patients are more prone to hemodynamic variability. In addition, they have~     increased possibility for difficult intubation The heart rate and blood pressure increase~     impaired the oxygen consumption. This was previously shown that Videolaryngoscopes minimaly~     effects the vital signs in normal patients. Videolaryngoscopy inreased the rate of success in~     normal and difficult airway. This study aimed to compare two laryngoscopes regarding~     hemodynamic parameters and intubation times in coronary bypass surgery.~   "
6385|NCT03483272|"~     HRS is divided into two types. A chronic kidney failure (HRS-2), which is predominantly~     related to end-stage disease and a more acute kidney failure (HRS-AKI). HRS-AKI is~     potentially reversible and develops subsequent to aggravation of a systemic circulatory~     vasodilatation, that triggers renal vasoconstriction and deteriorates renal perfusion and~     function. The albumin and terlipressin response is evaluated clinically, routinely for a week~     and reduces mortality with 23% compared to no treatment. Only 40-50% of the patients with~     HRS-AKI respond to the treatment with terlipressin.~      The treatment of hepatorenal syndrome type 1 (HRS-AKI) is aimed at improving blood flow to~     the kidneys. Flow changes associated to development of HRS have only sparsely been studied~     and not previously by MR technique and no previous studies have evaluated changes in flow~     induced by terlipressin. It has been hypothesized that development of HRS is associated to a~     deterioration in heart function with development of cardiomyopathy, which together with renal~     vasoconstriction leads to renal failure. Simultaneous MR-assessments of cardiac function and~     flows (especially the renal flow) in HRS-AKI have not previously been performed.~      The aim of the project is to develop new, fast and non-invasive methods to evaluate~     hemodynamic changes and individual pharmacological terlipressin response in patients with~     acute hepatorenal syndrome (type HRS-AKI)~      We expect a higher increase in renal blood flow in terlipressin-responders compared to~     terlipressin-non-responders and non-responders will generally have a lower basic renal flow~     and a decreased cardiac output.~      Study design and patients The study design is experimental and includes 30 cirrhotic patients~     with HRS-AKI. Patients with HRS-AKI are MR scanned before and 17 minutes after their first~     dose of terlipressin. ECHO is performed before first dose of Terlipressin and is repeated~     after one of the first doses of terlipressin. Clinically efficacy is defined in accordance to~     international guidelines at day-7 and 90 days mortality is registered. The screening period~     and treatments follow international and national guidelines for acute renal failure in~     patients with cirrhosis.~   "
6386|NCT03483259|"~     This is a single-center, randomized, open, single-dose, three-cycle cross-design study, which~     will be only enrolled Chinese male healthy volunteers.~   "
6387|NCT03483246|"~     Ulcerative colitis (UC) is a chronic relapsing inflammatory bowel disease. UC pathogenesis~     remains poorly understood but involves an inappropriate immune response toward an unbalanced~     gut microbiota (called dysbiosis) in predisposed hosts.~      The purpose of this study is to determine the effect of the fecal microbiota transplantation~     on UC.~   "
6388|NCT03483233|"~     Effective exploration of the environment, check for information to improve one's own~     performance, are fundamental abilities of human cognition. These abilities are dependent on~     the process of cognitive control.~      However, they are clearly impaired and uncontrollable in certain behavioral disorders such as~     obsessive-compulsive disorder (OCD). Compulsive checks of these patients, spontaneously~     associated with a feeling of intense uncertainty, suggest disturbances of evaluative and~     metacognitive functions. However, no biological observations have yet been able to feed these~     hypotheses.~      The evaluation of decisions and actions involves the middle cingulate cortex (MCC) (which~     belongs to a cortico-subcortical network structurally and functionally altered in OCD~     patients). Cingulotomy has long been used as a therapy in severe OCD, with However, the~     precise part of the cingulate cortex that contributes to check (and its pathological forms)~     remains to be discovered.~      The purpose of this research campaign is to determine, through functional magnetic resonance~     imaging (fMRI) and electroencephalography (EEG) in healthy human subjects:~        1. the location and role of the MCC region involved in normal check decision processes,~        2. determine the identity of the entire network involved~   "
6389|NCT03483220|"~     drug addiction is a major health hazard that has its effect on personality and behavior~     including the impulsivity and pattern of decision making. It also has its effect on both the~     structure and function of different brain regions mainly the prefrontal cortex.~      the aim of the study is to study the decision making styles and impulsivity among people with~     different psychoactive substance addiction, studying the change in the volume of prefrontal~     cortex in relation to drug addiction and studying the relation between drug impulsivity,~     decision making patterns and brain volume.~   "
6390|NCT03483207|"~     Initial treatment in the management of acute mesenteric vein thrombosis (MVT) is~     controversial. Some authors have proposed a surgical approach, whereas others have advocated~     medical therapy (anticoagulation). In this study, the investigators analyzed and compared the~     results obtained with surgical and medical treatment to determine the best initial management~     for this disease.~   "
6391|NCT03483194|"~     The management of hematological malignancies justifies the completion of a complete~     assessment before the start of treatment. This assessment includes imaging tests (computed~     tomography, position emission tomography, cavitary scintigraphy), biology and very often an~     exploration of the bone marrow by anterior or posterior iliac biopsy. Pains related to the~     disease (node compression, invasion of solid organs) are taken care of at the diagnosis and~     often relieved by the start of the specific treatment.~      However, pain related to medical procedure is often overlooked and can lead to psychological~     trauma in some patients who may refuse to repeat these essential actions to assess the~     response to treatment.~      Anxiety contributes to pain and various relaxation techniques have already proven their~     effectiveness. The goal of the protocol is to reduce the pain and anxiety associated with~     medical procedure by using virtual reality with a helmet proposed at the time of the gesture.~   "
6445|NCT03482479|"~     Naltrexone is an FDA approved drug (for alcoholism) that has found widespread use off-label~     to treat pain and improve quality of life at much lower doses than are used for the approved~     indication. There are a few scientific studies in three conditions (fibromyalgia, Crohn's~     disease, and multiple sclerosis) that suggest that this drug has benefit and is safe.~     However, considering the extent of use in other conditions, and uncertainty about the~     mechanism of action study is needed in a diverse set of diseases, including vasculitis.~      The purpose of this clinical trial is to determine if low dose naltrexone is effective in~     improving health-related quality of life (HRQoL) among patients with vasculitis. Although it~     is a pilot study, a placebo-controlled component is used because of the prominent placebo~     group effect seen in studies with self-reported subjective outcomes.~   "
6392|NCT03483181|"~     Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism~     (PE), is a common post-operative complication. The necessity for anticoagulant therapy after~     orthopedic surgeries is widely understood, but treatment administration patterns in the~     prevention of venous thromboembolism (VTE) after orthopedic surgeries during the hospital~     stay have yet to be examined.~      The main objective of this study is to perform a comparative effectiveness review examining~     the benefits and harms associated with venous thromboembolism prophylaxis in patients~     undergoing orthopedic surgeries.~      It is around efficacy and safety evaluation of using anticoagulant for thromboprophylaxis in~     patients undergoing orthopedic surgeries taking into the account the reliable selection of~     patients most benefit.~      The aims of this study is to analyze patient records in teaching hospitals database of our~     country (including: Hanoi Medical University, Bach Mai Hospital, Cho Ray Hospital, Viet Duc~     University Hospital) and compare the outcomes and costs between different types of~     anticoagulant medications that were prescribed for the prevention of VTE following orthopedic~     surgeries. This analysis will assess and quantify the outcomes, resource utilization, and~     cost of care for patients receiving rivaroxaban or enoxaparin. The outcomes of interest~     include the occurence of DVT and PE, rates of major bleeds, medical resource utilization, and~     total costs (medical plus pharmacy).~   "
6393|NCT03483168|"~     In last decade, the awareness has grown regarding the pain neuroscience education (PNE). In~     the literature, it has been found that there is strong evidence that the educational strategy~     of pain neuroscience education (PNE) can have positive effects on pain, disability,~     catastrophization, and physical performance in chronic musculoskeletal disorders. Nowadays,~     many physiotherapists integrate the PNE into the treatment of chronic pain. However, the~     importance of culturally sensitive approaches for the treatment of chronic pain has been~     proposed depending on the cultural differences of pain beliefs, pain cognitions, pain~     experiences and pain coping strategies in different ethnic populations. Therefore, the aim of~     this study is to compare the effects of a culturally sensitive PNE with a standard translated~     PNE on pain intensity, disability status, pain pressure thresholds and psychosocial factors~     (conceptualization of pain, pain beliefs, catastrophizing, kinesiophobia and illness~     perception) in Turkish patients with chronic low back pain (LBP).~      The effects of culturally sensitive PNE format will be compared with the standard translated~     PNE in a pilot trial. 40 Turkish patients (first generation migrant living around Ghent) with~     chronic LBP, between the age of 18 and 65 years, will be randomized to the culturally~     sensitive PNE or standard translated PNE. The content of 2 sessions PNE include the~     explanation about differences of acute and chronic pain, purpose of acute pain, production of~     acute pain and chronic pain, and potential sustaining factors for central sensitization, but~     presented in different ways. They will be subjected to an individual education session and~     they will receive a home education program. In session 2 (after 1 week), they will come back~     to ascertain that everything is understood.~   "
6394|NCT03483155|"~     Patients with coronary or other atherosclerotic cardiovascular disease and those at high risk~     of developing cardiovascular disease have been defined as the highest clinical priorities for~     prevention~   "
6395|NCT03483142|"~     assess the effect of using misoprostol in abdominal myomectomy operations on blood loss,~     duration of the operation and possible operative complications. Research question Does~     pre-operative misoprostol affect on intra-operative blood loss during and after myomectomy~     operation ?. Research hypothesis Pre-operative misoprostol may reduce intra-operative blood~     loss during and after myomectomy operation .~   "
6396|NCT03483129|"~     This research will assess the feasibility of conducting a randomised control trial to~     evaluate the effectiveness of a 15-minute one-to-one consultation to improve blood glucose~     control in pre-diabetes. The consultation will take the form of a 15-minute one-to-one~     consultation between a health-care practitioner and the patient in a primary care setting.~     Patients with a glycated haemoglobin (HbA1c) of between 42 and 47 mmol·mol-1 will be~     identified in general practise and will be eligible to participate. They will attend testing~     sessions at baseline (before the consultation), and at three months and six months post~     consultation. Body mass index (BMI), waist and hip girth, blood pressure and body composition~     will be recorded and blood analysed for HbA1c, cholesterol and dietary components. For a~     three-week period following each visit, urine will be collected, a 5-ml sample on nine~     occasions, and physical activity will be recorded in a sub group of participants. Urine will~     be analysed by flow infusion electrospray mass spectrometry (FIE-MS) to determine the~     metabolic content, providing an indication of the diet over the three-week sampling period.~     The research objectives are to assess the effectiveness of recruitment strategy and~     willingness of patients to engage in, and adhere to, the research process; to determine the~     impact of consultation on health outcome measures, including HbA1c, and to establish~     participant and practitioner perspectives of the consultation.~   "
6397|NCT03483116|"~     The purpose of this study is to determine the serum IgA response of three dose levels of the~     oral RV3-BB vaccine when administered in a neonatal schedule or when administered as a high~     dose in an infant schedule.~   "
6398|NCT03483103|"~     This is a Phase 2, open-label, multicenter study to determine the efficacy and safety of~     lisocabtagene maraleucel (JCAR017) in adult subjects who have relapsed from, or are~     refractory to, a single line of immunochemotherapy for aggressive B-cell non-Hodgkin lymphoma~     (NHL) and are ineligible for hematopoietic stem cell transplant (based on age, performance~     status, and/or comorbidities). Subjects will receive treatment with lisocabtagene maraleucel~     and will be followed for 2 years for safety, pharmacokinetics and biomarkers, disease status,~     quality of life, and survival.~   "
6457|NCT03482323|"~     This proposed study aims to examine the effect of classical aerobic exercise or tai-chi on~     1-year survival rate of lung cancer patients compared to usual care, as a primary outcome of~     this study. To understand the hypothesized outcomes of improved survival of lung cancer~     patients through physical exercise or tai-chi practice intervention, we will examine the~     changes in some subjective psychosocial outcomes and objective biomarkers that may be~     associated with the survival of cancer patients, as the secondary outcome of this study.~     Those biomarkers will be in following aspects: 1.) circadian rhythm, 2.) cardio-respiratory~     fitness, and 3.) immune functions. Secondary outcome measures include: quality of life,~     psychological distress, quality of sleep, fatigue, level of physical activity, circadian~     rhythms, cardio-respiratory fitness, physical functioning tests and immune function.~   "
6399|NCT03483090|"~     To evaluate the effectiveness of 4 g Swisse High Strength Deep Sea Krill Oil (Superba BOOST)~     daily on pain reduction in adults with mild to moderate osteoarthritis of the knee compared~     to placebo over a 6 month period.~      This is a multicentre, randomised, double-blind, placebo-controlled parallel-arm study.~      Applicants will be eligible to participate if they have mild to moderate OA of the knee.~     Diagnosis of OA of the knee will be made according to clinical diagnosis, using the American~     College of Rheumatology (ACR) Criteria for the classification of Idiopathic OA of the Knee~     and the Kellgren-Lawrence grading scale., In addition, eligible applicants will have been~     experiencing knee pain on at least 4 days per week, for at least 3 months and they will~     report knee pain between 4 and 8 cm (inclusive) on a visual analogue scale (VAS) for the 7~     days prior to Day 1 of the trial (Baseline). Severity of OA of the knee will be assessed~     based on X-ray performed at the Screening Visit using the Kellgren-Lawrence (KL) radiographic~     criteria, and participants with severe radiographic knee OA (KL joint space narrowing (JSN)~     above grade 3) will be excluded.~      Applicants will attend a screening visit following pre-screening assessments to assess their~     general health and eligibility for inclusion into the study.~      On Day 1 eligible participants will be randomly allocated to receive one of two study~     treatments. Participants will take the assigned treatments daily for six months.~      Participants will return to the clinic at 3 months and 6 months for study assessments.~     Participants will complete an online survey at 1, 2, 4 and 5 months to assess protocol~     compliance, adverse events and use of concomitant medications. Any queries from the survey~     will be followed up by phone call.~      A final participant online survey and phone call (if needed) will be conducted 28 days after~     the 6 month visit for a final safety assessment.~   "
6400|NCT03483077|"~     The primary objective of the single-rising dose (SRD) part (trial part 1) is to investigate~     the safety and tolerability of BI 730460 in healthy subjects following oral administration of~     single rising doses. The secondary objective is the exploration of the pharmacokinetics (PK)~     including dose proportionality, and pharmacodynamics of BI 730460 after single dosing.~   "
6401|NCT03483064|"~     In our daily clinical practice, one of the most frequent reasons for consultation~     physiotherapists is low back pain. Regardless of the origin of the problem, the approach from~     physiotherapy contemplates the reduction of pain through different procedures, among which~     all those included in electrotherapy stand out, as commented by McKenzie et al. The use of~     electric currents for therapeutic purposes is widespread and studied in the field of~     physiotherapy. However, the use of medium frequency currents, and more specifically~     interferential currents, provides participants with a series of important advantages, both~     for the patient and for the therapist.The study of low back pain in relation to treatment~     with interferential currents has a series of obstacles, among which the quantification of~     such pain and the establishment of the different parameters of the therapeutic procedure~     stand out. The first problem the investigators face are to objectify something that, in~     itself, is completely subjective: pain. In addition, pain measurement is our only guide to~     follow the evolution of the patient who suffers it. Another important problem, as discussed~     by Ward and Lucas-Toumbourou, has to do with the controversy between the different studies~     related to the treatment of low back pain with interferential currents.~      For all the above, the approach to low back pain is complex and affects the social, labor and~     economic scale of the individual and society. Low back pain is the main cause of public~     spending for welfare and work concepts. It suffers at some point in life up to 80% of the~     general population and each year generates a cost equivalent to approximately between 1.7 and~     2.1% of its gross domestic product in a European countries.~      There is a lack of valid scientific studies on some aspects of the clinical management of low~     back pain and the usual clinical practice does not seem to be based strictly on the results~     of the researches carried out. The available data suggest that there are abuses of procedures~     whose benefits and risks are uncertain, while others that have proven to be more effective,~     safe, effective and / or efficient are underutilized. For this reason, clinical practice~     guidelines for non-specific low back pain have been developed in several countries in recent~     years. Since the first clinical practice guidelines developed in America and the United~     Kingdom (Quebec Task Force in 1987. In 1994, more than 30 guides who claim to be based on~     scientific evidence have been developed.~      Electroanalgesia is a set of procedures consisting of the application of an electric current~     through electrodes placed on the skin of the patient in order to stimulate myelinated nerve~     fibers, fast driving. This activation triggers, at the central level, the implementation of~     descending analgesic systems of an inhibitory nature on nociceptive transmission, transported~     by small-caliber unmyelinated fibers. In this way, a reduction in pain is obtained. In other~     words, it is a question of carrying out a differential sensory stimulation,~     transcutaneously, of the tactile proprioceptive fibers, with a high speed of conduction, with~     the minimum response of the nociceptive fibers, of slow conduction, and of the efferent motor~     fibers.~      The application of medium frequency interferential currents (4,000 Hz), in addition to~     reducing the pain caused by the stimulation of thick nerve fibers, produces the normalization~     of the neurovegetative balance. According to De Domenico, this means a cushioning of the~     orthosympathetic system, which is reflected in muscle relaxation and improved circulation,~     which also helps to reduce pain.~      But the clinical impact of interferential currents on non-specific chronic low back pain~     remains poorly studied. Thus, clinical trials show some controversy and support its efficacy~     in combination with other treatments. A systematic review found that the interferential~     current demonstrates advantages over placebo and without treatment when associated with~     exercises and massages. In contrast, the European clinical practice guideline for the~     treatment of chronic low back pain concluded that there was no evidence of its effectiveness~     compared to sham intervention or placebo. However, recent studies of a randomized clinical~     trial with interferential currents on patients with nonspecific chronic low back pain report~     very favorable results in terms of the reduction of perceived pain and functional disability.~   "
6402|NCT03483051|"~     The current trial is designed to assess the safety and efficacy of sustained oral~     administration of inorganic nitrate in patients with severe aortic stenosis and to assess the~     mechanisms by which inorganic nitrate enhances oxygen uptake and exercise capacity in this~     population.~   "
6403|NCT03483038|"~     This is a phase II, single arm, non-randomized, open label study of liposomal irinotecan with~     FOLFOX in the neoadjuvant setting in patients with resectable or borderline resectable~     pancreatic cancer. The primary objective of this study is to investigate the safety and~     feasibility of this treatment regimen in this patient population.~   "
6404|NCT03483025|"~     Hair cleansing product tolerability study~   "
6405|NCT03483012|"~     This research study is studying the combination of a drug called atezolizumab and a radiation~     procedure called stereotactic radiosurgery (SRS) as a possible treatment for triple-negative~     breast cancer that has spread to the brain.~      The interventions involved in this study are:~        -  Atezolizumab~        -  Stereotactic radiosurgery (SRS)~   "
6406|NCT03482999|"~     To evaluate the impact of a high strength lysine-based adhesive (TissuGlu® Surgical Adhesive)~     on complications and revision rates in large flap surgery for decubitus repair.~   "
6407|NCT03482986|"~     The purpose of the study is to test how dietary habit interventions affect patients with poor~     weight loss outcomes after bariatric surgery.~   "
6408|NCT03482973|"~     The purpose of this study is to determine whether administration of a pecto-intercostal~     fascial plane block (PIFB) with bupivacaine is a more effective therapy for postoperative~     analgesia after cardiac surgery as compared to patients who receive a sham block of normal~     saline.~   "
6409|NCT03482960|"~     This study is designed to compare the capabilities of two novel imaging techniques: polarized~     perfluorinated gas mixed with oxygen, and hyperpolarized xenon mixed with N2 to detect~     changes in lung ventilation using MRI.~   "
6410|NCT03482947|"~     Caudal epidural block is a well-established and commonly performed regional neuraxial~     technique for providing intraoperative and postoperative analgesia in children scheduled for~     lower abdomen/perineal surgical interventions. Although the efficacy and safety of Caudal~     epidural block are fairly high, the associated complications, such as inadvertent dural~     puncture, unwarranted motor blockade of the lower limbs, and disturbance of bladder function,~     limit its use. Furthermore, a major limitation of an uncomplicated Caudal epidural block when~     administered as a single-shot technique is its brief duration of action (up to 6 hours),~     which makes administration of additional analgesics necessary .~   "
6411|NCT03482934|"~     To recognize predictors of left ventricular hypertrophy in hypertensive patients in Assiut~     government & to recognize the prognostic effect of central blood pressure measurement versus~     office brachial blood pressure measurement.~   "
6412|NCT03482921|"~     This study is to assess the predictive significance of visceral adipose tissue (VAT) and~     visceral adipose tissue /skeletal muscle tissue ratio (VAT/SMT ratio) for the prognosis in~     acute pancreatitis (AP) patients.~   "
6413|NCT03482908|"~     WEE Baby Care is a 6 month intervention that coordinates care across multiple settings-~     health care clinics and WIC clinics on responsive parenting practices to increase parenting~     competence thereby preventing infant rapid weight gain. The investigators will recruit~     mother/infant dyads in Central PA, who participate in the Women, Infants, and Children (WIC)~     program and receive clinical care from a Geisinger pediatrician participating in this study.~   "
6414|NCT03482895|"~     Gastric bypass with omega loop technic (OLGB) seems to be as effective as gastric bypass~     roux-en-Y (RYGB the reference) for the management of obesity and type 2 diabetes, but with~     less early surgical complications and more undernutrition in long terms.~      This study aims to explore the profile of secretion of entero-insular hormone after a meal~     test in OLGB patient vs RYGB to understand the mechanisms of the improvement of type 2~     diabetes after OLGB.~      Secondary objectives are to better understand the absorptive function of the gut after a~     gastric bypass, to understand why is there more undernutrition in long term after OLGB than~     after RYGB.~   "
6415|NCT03482882|"~     The purpose of this study is to assess the efficacy of pimavanserin when given adjunctively~     to a selective serotonin reuptake inhibitor/selective norepinephrine reuptake inhibitor~     (SSRI/SNRI) for the treatment of depression in adults with Parkinson's disease.~   "
6416|NCT03482869|"~     The purpose of this study is to test the routine feasibility of an image tool adapted from~     the WELCH questionnaire ( Walking estimated limitation calculated by history) to estimate~     walking impairment (The WELSH questionnaire: Walking estimated limitation stated by history)~     in patients investigated for walking impairment. Secondary aims correlation with the maximal~     walking distance.~   "
9391|NCT03443947|"~     comparing a new technique for airway assessment using tongue depressor versus conventional~     mallampati scoring system. Using tongue depressor to improve airway score is suggested to~     increase reliability of airway assessment model~   "
6417|NCT03482856|"~     Chronic spinal pain (CSP) includes chronic low back and neck pain. CSP is a highly prevalent~     and severely debilitating disorder characterized by tremendous personal and socioeconomic~     impact, long-term sick leave, low quality of life and very high socioeconomical costs. The~     current strategies for treating CSP are not yet optimal in reducing pain and related~     disability, urging the need for improvement. A possible problem is that the current~     approaches are often to limited and only address pain.~      Current treatments for CSP do not address associated complaints like sleeping problems which~     are however important issues. If present, sleeping problems may contribute to CSP severity~     and related disability. If left untreated, they represent a barrier for effective CSP~     management. Up to now, however, sleeping problems are hardly addressed and if so, it is~     mostly limited to sleeping medication. This is a problem since the efficacy and safety of~     drug treatment has not been established.~      Therefore, within the current innovative project we propose examining the added value of~     cognitive behavioral therapy for insomnia (CBT-I) to the current best physical therapy~     treatment for CSP. CBT-I includes changing negative thoughts about sleep, sleep hygiene,~     altering sleeping patterns, and teaching relaxation skills.~      The objectives of the study are to examine if CBT-I combined with the modern physical therapy~     approach (education about pain followed by exercise therapy) is more effective than the~     modern physical therapy approach alone for reducing pain, improving sleep and functionality~     in CSP patients with sleeping problems.~      Therefore 120 CSP patients with sleeping problems will be randomly divided over the 2~     treatment programs (60 per group) and will be assessed before and after their 14-week therapy~     program consisting of 18 therapy sessions. Comparisons will be made for pain severity, sleep~     quality and functionality.~   "
6418|NCT03482843|"~     Vitamin D has been promoted to vascular regeneration in non-cerebral arteries because of its~     anti-inflammatory properties. Cerebral vasospasm (CVS) as the most feared complication after~     subarachnoid hemorrhage (SAH), correlated with higher mortality and poor outcome, is the~     result of a multifactorial mechanism with inflammation as one of the main role players. The~     investigators therefore hypothesized that vitamin D attenuates cerebral vasospasm and~     increases the chance for favorable outcome after SAH.~   "
6419|NCT03482830|"~     Emergency laparotomies, which most often is performed due to high risk disease (bowel~     obstruction, ischemia, perforation, etc.), make up 11 % of surgical procedures in emergency~     surgical departments, however, give rise to 80 % of all postoperative complications. The~     30-day mortality rates in relation to these emergent procedures have been reported between~     14-30 %, with even higher numbers for frail and older patients. The specific reasons for~     these outcomes are not yet known, however, a combination of preexisting comorbidities, acute~     illness, sepsis, and the surgical stress response that arise during- and after the surgical~     procedure due to the activation of the immunological and humoral system, is most likely to~     blame. The complex endocrinological response and consequences of this response to emergency~     surgery are sparsely reported in the literature.~      The aim of this PHASE project is to evaluate and describe the temporal endocrine, endothelial~     and immunological changes after major emergency abdominal surgery, and to associate these~     changes with clinical postoperative outcomes.~   "
6420|NCT03482817|"~     This Study evaluates the Effect of St. John's Wort dry Extract Ze 117 on Several Cytochrome~     P450 Enzymes and on Transporter P-Glycoprotein in Healthy Volunteers.~   "
6421|NCT03482804|"~     The inclined position at 30 ° in case of transient respiratory discomfort is recommended~     since the consensus conference of September 2000. This recommendation is based on a low level~     of evidence (grade C). This advice is found in the health book, and in many tips for parents.~     However, it does not comply with the recommendations of the American Academy of Pediatrics~     for sleeping on the back, on a firm mattress and without other objects in the bed.~      70% of pediatricians advise this position in a specific medical context according to a study~     of Bellaïche conducted in 2013. 40% of parents use it for no particular reason.~      Anatomically, the upper airways of infants are of reduced caliber, and therefore at risk of~     obstruction.~      A study by Bergougnioux on the cases of MIN in infants wearing a wrap-around sling shows that~     the flexion of the neck causes the chin to be positioned against the chest and contributes to~     the suffocation of the infant. This is especially important in infants under 3 months whose~     neck muscles do not yet support the weight of the head.~      The 2009 InVS national survey of unexpected infant deaths shows that bed crashes accounted~     for 11.1% of all deaths reported. Among unexplained deaths, maladaptive bedding was a~     contributing factor, including the use of a pillow in the bed in 24.3% of cases.~      It was observed in the study by Kornhauser Cerar et al in 2009 that half-sitting in a car~     seat for an extended duration was at the origin of a significant desaturations rate, which~     was also found in the car bed group. The control group hospital bed was not subject to~     these desaturations. These results support the fact that only an adapted bedding that~     complies with the recommendations protects against asphyxiation.~      Since 2016, INPES recommends in its advice sheet on bronchiolitis for parents, a flat bed on~     the back.~      Hypothesis :~      The inclined position in infants under one year of age is at risk of unexpected death of the~     infant by obstruction of the upper airways, because of the changes of position that it~     entails, including a risk of slipping at the bottom of the bed and of asphyxiation under the~     covers.~   "
6422|NCT03482791|"~     The investigators plan to include both operable and inoperable patients with esophagus cancer~     in this prospective trial. Since both proton and photon treatments are biologically~     equivalent, the investigators do not expect a difference in tumor control compared to~     intensity modulated radiation therapy (IMRT). The investigators have a prospective experience~     of physician-reported toxicity and patient outcome using IMRT for patients with inoperable~     esophagus cancer that will serve as a comparison group. For the resectable patients receiving~     trimodality therapy (chemoradiation followed by surgery), the investigators will carefully~     track toxicity and patient outcomes prospectively. The central hypothesis is that the~     biologic efficacy for tumor control should be similar between protons and photons, and~     therefore survival measures should be similar between the two groups, but that the main~     difference lies in the total severe toxicities experienced by the patients undergoing~     therapy.~   "
6423|NCT03482778|"~     AYAs with cancer experience many challenges that impact their health-related quality of life~     (HRQOL) but few measures adequately capture AYAs' HRQOL in valid and reliable ways. The main~     goal of the study is to expand the use of the Patient-Reported Outcome Measurement~     Information System (PROMIS) to provide valid and reliable assessment of important HRQOL~     concerns for AYAs. The study team will do this by validating existing PROMIS measures and~     developing and validating new measures of financial distress, fertility/parenthood concerns,~     and body image concerns for AYAs with cancer.~   "
6424|NCT03482765|"~     For the current study, the primary outcome is to evaluate the effect of IP on abdominal pain.~      The secondary outcome is to assess the effect of IP on IBS-Symptom Severity, IBS-related~     quality of life, stool form and consistency and on mental status.~      Thus providing an effective objective in improving the gut health and symptomatic relief in~     IBS patients.~   "
6425|NCT03482752|"~     Clinical trial for subjects with autoimmune pulmonary alveolar proteinosis (aPAP) who have~     completed the IMPALA trial (NCT02702180).~      At the Baseline visit, eligible subjects may continue or re-start treatment with 300 µg~     inhaled molgramostim (recombinant human Granulocyte-Macrophage Colony Stimulating Factor;~     GM-CSF) administered intermittently in cycles of seven days molgramostim, administered once~     daily, and seven days off treatment.~      Subject will be treated with inhaled molgramostim for up to 36 months.~      During the trial, whole lung lavage will be applied as rescue therapy.~   "
6426|NCT03482739|"~     This is a single-center, open-label study on safety, tolerability and immunogenicity of~     Gardasil®9 in 18 to 45 year-old HIV patients, in 18 to 55 year-old solid-organ transplant~     (SOT) patients.~      This study will enrol 140 HIV patients with CD4+ count of >200cells/mm² and 170 SOT patients,~     all of whom have not yet received a prophylactic HPV vaccine. The 170 SOT patients will be~     equally divided over 3 different SOT patient groups, namely heart, lung and kidney transplant~     patients. Therefore the target is to include approximately 57 heart transplant patients, 57~     lung transplant patients and 57 kidney transplant patients. Enrolment in a SOT subgroup will~     be stopped when 57 patients have been included unless recruitment cannot be achieved within~     one of the other SOT-patient population.~      All enrolled subjects will receive a 3-dose regimen (Day 1, Month 2, and Month 6) of~     GARDASIL®9. Serum samples will be collected on Day 1 and Month 7 for anti-HPV 6, 11, 16, 18,~     31, 33, 45, 52, and 58 antibody determination. The time point for comparison of immune~     responses will be Month 7, or approximately 4 weeks after the administration of the third~     dose. The safety/tolerability profile of the vaccine will be evaluated in all subjects in the~     study. Safety information will be collected on Day 1 through 1 month following the third~     vaccination or for a total of approximately 7 months for each subject.~      The immunogenicity and the safety data will be analyzed per group of patients. More~     specifically a separate analysis of HIV and SOT patients is planned, since it is expected~     that the immunosuppressive therapy of SOT patients might have a more profound effect on~     immunogenicity following vaccination.~      This study will provide a comparison of immunogenicity of Gardasil ®9 in immunocompromised~     patients, with historical controls. The number of subjects to be enrolled in the study was~     determined based on the primary immunogenicity objective.~   "
6427|NCT03482726|"~     This study will utilize a combination of cardiovascular analysis, 3D motion capture, and a~     software package, Metrifit, to monitor measures of well-being to comprehensively evaluate~     both the musculoskeletal and physiological responses following a HIIT training intervention~     at EOC as a means of improving performance and potentially reducing injury risk factors. This~     holistic approach of physiological and biomechanical factors is unprecedented. This is the~     first interventional study to determine the effect of high intensity training at EOC on~     cardiovascular performance, kinematics and well-being which may minimize risk of injury~     factors.~   "
6428|NCT03482713|"~     This estimation study (no hypotheses) will evaluate the safety, tolerability, and efficacy of~     gefapixant (MK-7264) in Japanese adult participants with unexplained or refractory chronic~     cough.~   "
6429|NCT03482700|"~     This study will look at the impact of care delivery by a specialist respiratory doctor~     compared to general practitioners for patients with COPD in East Birmingham. The primary~     outcome will be to compare the rates of provision of guideline-based care in intervention and~     control practices.~   "
6430|NCT03482687|"~     The purpose of this study is to evaluate Me & You: Building Healthy Relationships, a~     classroom- and computer-based healthy relationships and dating violence prevention curriculum~     for 6th grade students, in a large, urban public school district in Southeast Texas.~   "
6431|NCT03482674|"~     The increasing prevalence of type 2 diabetes mellitus is a worldwide problem. In preventing~     risk factors and unhealthy lifestyle through improved health literacy, chances are seen to~     delay or even avoid type 2 diabetes mellitus. The aim of the DIMINI-project is to prevent~     type 2 diabetes mellitus and to strengthen the health literacy of people at increased risk of~     developing it. For this purpose, people at increased risk are first identified by using the~     standardized screening tool Finnish Diabetes Risk Score (FINDRISC) adapted for Germany.~     Identified risk persons then receive a needs-based, modular lifestyle intervention including~     nutrition tips and physical exercises either paper- or app-based.~   "
6432|NCT03482661|"~     Patients referred for magnetically controlled capsule endoscopy (MCE) in the participating~     center from June 2017 to November 2017 were prospectively enrolled. Magnetic steering of MCE~     was performed after standard gastric examination. Capsule endoscopy completion rate (CECR),~     gastric transit time (GTT), pyloric transit time (PTT) and rapid gastric transit rate (GTT ≤~     30 min) were compared with the historical control group enrolled from January 2017 to May~     2017.~   "
6433|NCT03482648|"~     This clinical trial is the first-in-human study of BBT-401-1S. The purpose of this phase 1~     study is to assess the safety and tolerability of single and multiple ascending oral doses of~     BBT-401-1S in healthy adult subjects.~   "
6434|NCT03482635|"~     This trial has two sequentially enrolling parts with different objectives. The primary~     objectives of this trial are~        -  to prove the concept of clinical activity of BI 655130 in patients with~          moderate-to-severely active ulcerative colitis who have failed previous biologic~          treatments and to identify efficacious and safe dose regimens in Part 1 (Phase II)~        -  to confirm efficacy and safety of BI 655130 in patients with moderate-to-severely active~          ulcerative colitis who have failed previous biologic treatments in Part 2 (Phase III)~        -  To provide, along with induction study 1368-0018 and the run-in cohort of 1368-0020, the~          target population to be evaluated in study 1368-0020.~   "
6435|NCT03482622|"~     The main objective of this research is to develop a new scanning technology called the Fast~     Raman device, to accurately check the skin removed by the surgeon and detect any residual~     cancer cells; if found, additional skin can then be removed by surgeons on the same day. The~     device will be tested first for patients undergoing Mohs micrographic surgery, then be~     extended to wide-local excisions of basal cell carcinoma (BCC). This study will determine the~     validity (sensitivity/specificity) and reliability (inter- and intra-user variability) of the~     Fast Raman device for checking the completeness of tumour removal during Mohs micrographic~     surgery of BCC.~   "
6436|NCT03482609|"~     The purpose of this study is to explore the effect of postoperative referred pain in the left~     shoulder on short-term outcomes for laparoscopic gastrectomy~   "
6456|NCT03482336|"~     Regulated nutrition information is complex, using decimal places and percentages. Front of~     pack (FOP) labels provide simplified nutrition information on the front of packages. It has~     been suggested that the traditional approach to nutrition labeling is difficult for children~     to use; this is unfortunate as childhood is a critical time for developing long-lasting~     eating habits and children influence purchase decisions.~      Materials and Methods Children aged 6-10 played a video game in which participants fed~     Munchy Monster the healthier of two cereal products presented on a computer screen. Across~     trials the FOP format varied in a 2 (color/no color) x 2 (facial emotion icon/no facial icon)~     factorial design. Within a trial both cereals presented the same FOP format, with one cereal~     healthier than the other.~      Results Data suggest that color coding and/or facial icon significantly benefits selection~     accuracy and speed, particularly for the youngest children. Minimal training (awareness of~     the FOPs existence and that it might contain nutrition information) further improved accuracy~     and speed of responses.~      Conclusions FOPs that leverage visual indicators assist even young children in assessing the~     nutritional value of a product.~   "
6437|NCT03482596|"~     Over 3 million in the United Kingdom are now diagnosed with type 2 diabetes, with current~     estimates suggesting this will rise to over 5 million by 2025. Type 2 diabetes increases the~     risk of developing cardiovascular disease, kidney disease, depression, neuropathy and~     dementia, along with being a leading cause of amputation and adult blindness.~      Sedentary behaviour, defined as any waking moment spend sitting or reclining with energy~     expenditure equal to or less than 1.5 METs, has emerged as a risk factor in the development~     of type 2 diabetes. Recent evidence has shown that breaking up prolonged sitting with regular~     short bouts of activity or standing lower postprandial glucose and insulin. However, the~     effectiveness of breaking prolonged sitting on glucose metabolism over a longer period of~     time is unknown. Therefore, the aim of this study is to investigate whether the reduction in~     postprandial plasma glucose in response to breaking prolonged sitting time is maintained~     following an intervention to reduce and break up prolonged sitting over a four to five week~     period.~      The study will be a single group intervention with pre and post randomised measurement~     conditions (prolonged sitting and light upright breaks) at both time points. A sample of 43~     people (34 to complete), aged 50-75, identified as at risk of or with (drug naive) type 2~     diabetes will be sought. The intervention will last approximately 5 weeks. Experimental~     conditions will be conducted before and after the intervention to assess whether reducing and~     breaking up prolonged sitting in free living effects glucose metabolism.~   "
6438|NCT03482583|"~     Tobacco use among cancer survivors reduces the effectiveness of cancer treatments, increases~     the risk for additional primary cancers, and increases mortality. Implementation of tobacco~     treatment for cancer patients is challenging, but may be improved substantially with~     clinically-efficient and sustainable solutions to accurately identify tobacco users, direct~     them to evidence-based treatment, and provide demonstrable outcomes for stakeholders.~      At UF Health Cancer Center (UFHCC), patient access and utilization of tobacco use treatment~     are sub optimal. Further, UFHCC has a largely rural catchment area with a high burden of~     tobacco-related disease and mortality. To address this research-to-practice gap using a~     mixed-methods approach to assess the relevant contextual factors at UFHCC and evaluate the~     feasibility of implementing a multi-level intervention to increase tobacco treatment~     utilization and improve health outcomes.~      This study uses a mixed methods approach and will inform the design of a pragmatic clinical~     trial to improve the delivery of tobacco use treatment services to cancer patients. Guided by~     a conceptual model that emphasizes patient, provider, and organizational characteristics, the~     study team will identify factors that influence the implementation process at the UFHCC. The~     ultimate goal of the proposed research is to provide new knowledge to facilitate the~     widespread adoption, implementation, and dissemination and sustained utilization of~     evidence-based tobacco use treatments in cancer care settings.~   "
6439|NCT03482570|"~     The purpose of this research is to objectively assess activity behaviours (i.e., physical~     activity and sedentary behaviour) in patients with malignant pleural effusion. First, we aim~     to describe the physical activity and sedentary behavior of patients with MPE in Hong Kong.~     Secondarily, we aim to assess the relationships between activity behaviours and survival,~     quality of life, and respiratory symptoms e.g. shortness of breath.~   "
6440|NCT03482557|"~     This research study is evaluating whether contrast enhanced mammography can be used as an~     alternative to breast Magnetic Resonance Imaging (MRI) for cancer screening~   "
6441|NCT03482544|"~     The application of tourniquet is indispensable for a bloodless surgical area in total knee~     arthroplasty surgery. The release of tourniquet produces reactive oxygen species which can~     cause injury and then ischemia-reperfusion injury emerge. Our aim in this study is to~     investigate effects of pregabalin, GABA analog drug, on the tourniquet induced~     ischemia-reperfusion injury.~   "
6442|NCT03482531|"~     Induction of labor is a common obstetric procedure that is routinely performed worldwide.~     However, when cervical conditions are not favorable (bishop <6), induction of labor is~     preceded by cervical ripening, usually with prostaglandins. The method of ripening most~     commonly used in France (89% of maternity wards) is the dinoprostone vaginal insert. In the~     majority of hospitals in France, dinoprostone vaginal inserts are usually placed in the~     morning, because of the higher availability of personnel (midwives and nurses). However,~     morning placement might increase the likelihood of the delivery occurring at night, since the~     mean interval between the insert placement and delivery is about 13 to 20 hours. Many studies~     have now shown that the risk of obstetrical complications, as well as neonatal morbidity and~     mortality is increased when deliveries occur at night. Several factors have been suggested~     behind the increased morbidity at night, including the lower number of personnel working, the~     fatigue associated with night work and the disruption of the circadian rhythm, and the~     insufficient supervision of residents.~      Very few studies have evaluated the importance of the timing of placement of the intravaginal~     dinoprostone insert, and its influence on the occurrence of night deliveries. Some~     investigators have recently performed a retrospective study at Angers university hospital~     that assessed the time interval between placing the dinoprostone vaginal insert and delivery,~     as well as the factors impacting the time to delivery, and found that nulliparity, obesity, a~     closed cervix on initial examination, and intact membranes at the time of insertion increased~     the time to delivery. Moreover, the investigators proposed a regression equation that allows~     to calculate the mean time from insert placement to delivery for each patient, and have~     decided to incorporate it in the routine practice.~      The investigators have decided to analyze the validity of the mathematical model. The~     consequence would be, thanks to a personalized timing for placement of dinoprostone vaginal~     insert based on every patient's characteristics (parity, BMI, cervical dilation and state of~     membranes), a decreased number of deliveries occurring between 12 p.m. and 6 a.m.~   "
6443|NCT03482518|"~     Introduction: Persistent heel pain from plantar fasciitis and calcaneal spurs, as well as~     metatarsalgia, are very common and prevalent complaints in the Brazilian population. One of~     the recommended treatments for these conditions in the literature is the use of insoles.~     However, the use of this feature requires the individual to wear closed shoes and this is an~     obstacle to treatment in cities with hot weather. Thinking about an alternative treatment,~     the customized slippers with the corrective elements of the insoles can be an alternative to~     increase the adhesion to this type of treatment. Objective: To evaluate the effectiveness of~     the insoles adapted in slippers in the improvement of the pain and the function in~     individuals with persistent pains in the backfoot of the city of Santa Cruz, RN. Methodology:~     This is a double-blind, randomized, controlled clinical study in which 66 patients diagnosed~     with persistent back pain and metatarsalgias will be divided into two groups. The~     intervention group will receive a customized slipper with foot pieces and synthetic leather~     cover, and the control group will receive a slipper without customization, only with a~     synthetic leather cover as used by the intervention group. The evaluator and the patient will~     be considered blind. Evaluations will be performed at baseline (T0), after 12 weeks of~     wearing the slippers (T12) and a reassessment at week 16 (T16) for pain monitoring. The~     evaluation instruments used will be the EVA (visual pain scale) and the algometer in the~     painful region of the foot; FFI - Foot Function Index questionnaire and FAAM questionnaire -~     Foot and Ankle Ability Measure for functional evaluation, and finally the 6 - minute walking~     test for walking performance. Statistical analysis: Data will be analyzed by t-test,~     Mann-Whitney test, repeated-measures ANOVA and intention-to-treat analysis.~   "
6444|NCT03482492|"~     This study focused on to determine postoperative analgesic efficacy of tramadol compared to~     tramadol with addition of paracetamol after a lumbar disc surgery.~   "
9979|NCT03436199|"~     This is a multicenter, 3-arm, randomized, placebo-controlled, double-blind, parallel-group~     study of ADS-5102 (amantadine extended release [ER] capsules) in MS patients with walking~     impairment. ADS-5102 will be administered once daily at bed time.~   "
6446|NCT03482466|"~     A commonly used therapy for post-traumatic stress disorder (PTSD) that often (but not always)~     gives good results is exposure therapy: When the patient (for example, Veterans who have~     attacks of anxiety when a noise startles them) talks about the trauma that precipitated the~     PTSD, she or he slowly becomes less sensitive to PTSD. This works only on some patients. The~     investigators propose to expose PTSD patients to a number of training sessions in which~     they will be in a virtual world (similar to a video game) driving a car through a place~     resembling Iraq. This will happen inside an MRI machine, and the investigators will obtain~     brain images while the patient is exploring the virtual Iraq environment. The investigators~     will project on the screen a bar that will let the patient know, in real time, which is the~     state of her or his brain, from CALM to STRESS. The job of the patient will be to try to come~     up with personal strategies (breathe slowly, think calming thoughts) to try to bring the bar~     to CALM. The investigators believe that after a number of sessions, the patient will be able~     to create personalized mental strategies to bring their brain to CALM state, even in real~     life. This could become a much stronger way of performing exposure therapy. Finally, the~     investigators will use a wearable device (similar to a wristwatch) to be able to study~     physical activity and sleep patters in PTSD patients through the training, in the hope that~     the investigators may find a way to objectively study when a patient is doing better.~   "
6447|NCT03482453|"~     The purpose of this study is to assess the safety, tolerability and to identify a tolerable~     single oral dose of TAK-788, and to characterize the effects of a low-fat meal on the PK of~     the TAK-788, administered as oral formulation in healthy participants.~   "
6448|NCT03482440|"~     Women who develop preeclampsia during pregnancy are more likely to develop cardiovascular~     disease later in life, even if they are otherwise healthy. The reason why this occurs is~     unclear but may be related to blood vessel damage and increased inflammation that occurs~     during the preeclamptic pregnancy and persists postpartum. The purpose of this investigation~     is to 1) determine the mechanisms contributing to this lasting blood vessel damage and~     chronic inflammation, and to 2) identify factors (both physiological and pharmacological)~     that mitigate these negative effects in order to inform better clinical management of~     cardiovascular disease risk in women who have had preeclampsia.~   "
6449|NCT03482427|"~     In this pilot study, the investigators will assess the clinical utility and feasibility of~     the Healthy Heart Score in the primary clinical care setting for the primordial prevention of~     cardiovascular disease. The investigators will conduct a randomized clinical trial to test~     the lifestyle intervention based on the Healthy Heart Score compared to usual care. The aim~     is to include 100 participants (50 in each group). Each participant will complete 2 visits~     (initial and a follow up visit after 12 weeks).~   "
6450|NCT03482414|"~     This 12-week randomized controlled trial involves two intervention groups (i.e.,~     single-player game group, competition game group) and one control group (i.e., conventional~     checkerboard group). The main objective of this study is to examine the effects of game-based~     training on patient motivation, exercise duration, and functional outcomes in comparison with~     the control group.~   "
6451|NCT03482401|"~     The aim is to characterise the metabolic profiling of dietary polyphenols in normal and~     malignant breast tissues from breast cancer patients.~   "
6452|NCT03482388|"~     This is an online randomized controlled trial (RCT) comparing men who have sex with men (MSM)~     exposed to a crowdsourced intervention to MSM who did not receive the intervention to~     determine the effect on Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) testing.~     Participants will be randomly assigned in a 1:1 ratio to intervention or control using a~     computer-based allocation system. Participants will be assessed for primary and secondary~     outcomes four weeks after randomization.~   "
6453|NCT03482375|"~     Gallstone disease affects over 20 million Americans. Among patients with gallbladder disease,~     the prevalence of choledocholithiasis (stones in the bile duct) is estimated to be 10-20%.~     Endoscopic retrograde cholangiopancreatography (ERCP) is considered the standard of care for~     removing stones in the bile duct utilizing a variety of conventional methods including~     biliary sphincterotomy, sphincteroplasty, extraction balloon, retrieval basket, and~     mechanical lithotripsy. After removal of stones from the bile duct, an occlusion~     cholangiogram is usually performed to confirm complete bile duct clearance. However,~     cholangiogram can miss residual stones in 11- 30% of cases - especially in the setting of a~     dilated bile duct, large stones, severe pneumobilia, juxtapapillary diverticulum, primary~     sclerosing cholangitis, and after lithotripsy (mechanical, electrohydraulic, or laser). The~     approach to patients with choledocholithiasis requires careful attention because missed bile~     duct stones can cause recurrent biliary symptoms, pancreatitis, cholangitis, and has~     significant cost implication with the need for repeat imaging and/or procedures.~   "
6454|NCT03482362|"~     Vecchione et al showed that suppression of RANBP2 results in mitotic defects only in~     BRAF-like colon cancer (CC) cells, which leads to cell death. Mechanistically, RANBP2~     silencing reduces microtubule outgrowth from the kinetochores, thereby inducing spindle~     perturbations, providing an explanation for the observed mitotic defects. Vinorelbine mimics~     RANPB2 silencing in BRAF-like and BRAFV600E CC cell lines.~      These preclinical data represent a strong rationale to also explore the anti-tumor activity~     of vinorelbine in patients with advanced BRAF-like (both BRAFm and BRAF wild type) CC. Tumors~     having this gene signature are referred to as BRAF-like and have a similar poor prognosis~     irrespective of the presence of BRAF(V600E) mutation. Since vinorelbine is standard of care~     in advanced breast and NSCLC, there is ample experience with the dose and schedule as well as~     with the safety profile and supportive measures required to prevent side-effects.~   "
6455|NCT03482349|"~     This study will explore if there are any difference in functional outcomes between two~     different surgical procedures for total knee replacement: robot-assisted versus~     manually-executed total knee arthroplasty.~   "
6458|NCT03482310|"~     This study is for people who have a paralyzed arm and hand from a spinal cord injury, who~     have also received a recording electrode array in the brain as part of the BrainGate study.~     The study will look at the ability of these participants to control different grasping~     patterns of the hand, both in virtual reality and in his/her actual hand. Movement of the~     participant's hand is controlled by a functional electrical stimulation (FES) system, which~     involves small electrodes implanted in the arm, shoulder and hand that use small electrical~     currents to activate the appropriate muscles.~   "
6460|NCT03482271|"~     There is increased demand on emergency departments (ED) across the UK. The services are~     becoming stretched and as a result waiting times are increasing and patient care is~     suffering.~      By linking together patient data from different hospitals and services across Yorkshire,~     researchers are able to build a more complete picture of how emergency and urgent care (UEC)~     services in the region function.~      This picture will help researchers understand the flow of patients through EUC services, to~     understand what the most common health issues are and to better plan community services in~     the future. The anonymous data can help scientists understand EUC services across an entire~     region and suggest improvements in a much more synchronised way.~      Health service managers will also be able to understand how one ED in Yorkshire compares to~     another. By re-using existing data researchers will also allow hospitals to learn lessons~     from each other so that each local service can improve and deliver better care for its~     patients.~      In the future, this information will help researchers to plan ahead and forecast disease~     outbreaks. The data used will, over time, tell a story that will help deliver better and more~     targeted care.~      The aim of the research project is to build a unique dataset based on expertise already being~     developed across the Yorkshire and Humber region. We will collect routine NHS data from a~     number of providers of EUC and link the data to provide a coherent picture of EUC demand.~     This rich data source will allow the EUC services to be viewed as a whole system, enabling~     demand on the system by patients to be analysed as well as the flow of patients through the~     system.~   "
6461|NCT03482258|"~     Diet has a considerable influence on microbiota composition and the intake of either~     prebiotics (microbiota-specific food or probiotics (live microbiota species) has been shown~     to induce positive effects in both anxiety and depression. At present there are few studies~     exploring stress-related conditions such as emotional/comfort eating behaviours, particularly~     in individuals who have experienced early life stress and/or find stress difficult to deal~     with in regards to gut microbiome composition and subsequent behavioural outcomes. Early life~     stress has been linked to the development of bulimia nervosa and anorexia nervosa in~     adolescence and adulthood and since the gut microbiota has been proposed as having a causal~     role in the aetiology and/or maintenance of disordered eating, an empirical question is~     whether the microbiota may mediate the relation between stress and disordered eating. This is~     an investigation into the effects of chronic daily consumption of a prebiotic on~     stress-related eating and mood.~   "
6462|NCT03482245|"~     Our data suggest that modulating the characteristics of light carries the potential to modify~     the host response to injury and critical illness and thus, improve outcome. The ability to~     modify the host response to the stress of major operations and sepsis carries immense~     potential to improve patient care.~      This study is an experimental investigation of exposure to blue (480nm) light in the setting~     of appendectomy for appendicitis, colon resection for diverticulitis, or treatment of~     pneumonia~      The exposure of interest is blue light applied prior to surgery and during the 24 hour period~     after surgery.~      For the cohort with pneumonia, exposure of interest is blue light applied upon diagnosis of~     pneumonia for a 24 hour period after diagnosis and then for a 12 hour period on days 2 and 3~     of treatment of pneumonia.~      The control group is comprised of controls that have undergone a similar operation or~     treatment for pneumonia but without exposure to blue light.~      The outcome of interest is change in the inflammatory response after surgery for appendicitis~     or diverticulitis as measured by the following parameters: white blood cell count, heart~     rate, the development of abdominal abscess, serum cytokine concentrations.~      The outcome of interest is change in the inflammatory response during pneumonia as measured~     by the following parameters: white blood cell count, heart rate, and serum cytokine~     concentrations.~   "
6463|NCT03482232|"~     Retrospective observational study in a random selection of 5% of digital records active~     between 2014 and 2017 to quantify the frequency of Do not do primary care recommendations,~     calculating the over-cost related to them and study reviewing a random selection of cases~     previously identified to determine whether patient suffered adverse events and their~     over-cost.~   "
6464|NCT03482219|"~     The purpose of this study is to test two rehabilitation programs to improve arm function for~     patients with scleroderma. This is a Phase 2 randomized controlled trial in which~     participants will be assessed at baseline, 8 weeks, and 18 weeks. Participants will be~     randomized into an intensive intervention (8 individual sessions of occupational therapy plus~     a home exercise app) versus a home app treatment alone. The results of this study will be~     used to design a large multi-site trial in which optimized rehabilitation strategies can be~     used to help patients improve their arm function.~   "
6465|NCT03482206|"~     Traumatic brain injury (TBI) affects 1.7 million people in the United States each year,~     resulting in 2.5 million emergency department visits, 280,000 hospitalizations, >50,000~     deaths, and more than $60 billion in economic cost. TBI also affects >30,000 military~     personnel annually and almost 8% of veterans who received care between 2001 and 2011.~     Post-traumatic neurologic outcome depends on the severity of initial injuries and the extent~     of secondary cerebral damage. Ischemia is the most common and devastating secondary insult.~     Ischemic brain damage has been identified histologically in ~90% of patients who died~     following closed head injury, and several studies have associated low cerebral blood flow~     (CBF) with poor outcome. Specifically, CBF of less than 200 ml/min has been shown to be the~     critical lower threshold for survival in neurointensive care patients. In addition to~     intracranial hypertension and cerebral edema, systemic hypotension and reduced cardiac output~     contribute substantially to posttraumatic cerebral ischemia. Additionally, the carotid artery~     is the most common site of blunt cerebral vascular injury (BCVI), which may further~     compromise CBF and cause subsequent death or debilitating stroke. Specifically, high grade~     internal carotid arterial (ICA) injuries are associated with the highest mortality and stroke~     rate.~      The investigators' goal is to develop of a wearable noninvasive, continuous, automated~     ultrasound sensor to accurately measure extracranial ICA flow volume. In doing so, the~     investigators aim to enable early detection of CBF compromise, thereby preventing secondary~     ischemic injuries in TBI patients. To achieve this goal, the investigators plan to first~     build a prototype wearable ICA ultrasound senor with integrated signal processing platform,~     then test its accuracy in an in vitro system and healthy human subjects.~   "
6482|NCT03481985|"~     The overarching goal of this project is to discern how closure of Fontan fenestrations in~     patients with single ventricle heart disease will affect hepatic congestion, a major~     determinant of chronic liver disease. We will employ transient elastography (Fibroscan) to~     obtain liver stiffness measurements (LSM) before and after fenestration closure to study the~     impact of this intervention on hepatic congestion.~   "
6835|NCT03477383|"~     This study is a prospective, observational multi-center cohort study. The study will consist~     of patients undergoing heart transplantation. The main purpose is to test a new biomarker for~     rejection against the gold-standard, the endomyocardial biopsy (EMB). 80 patients will be~     included, both children and adults.~   "
6466|NCT03482193|"~     Obesity in children and adolescents has become a major public health problem in recent years.~     In Belgium, 20% of people aged between 2 and 17 are overweight and 7% suffer from obesity.~     While studies often associate this overweight with socio-economic level, other factors, such~     as health literacy (HL), may also play a role. Among adolescents, some studies have shown an~     association between the level of HL and the Body Mass Index (BMI). Our study aims to~     investigate the association between HL of adolescents and their BMI.~      This is a cross-sectional survey among 9 high schools in a medium city of Belgium, including~     254 high school students aged between 12-17 years. Health literacy was assessed by the Health~     Literacy Measure for Adolescents (HELMA). Student's age, sex, weight, size and parental~     socio-economic status are gathered in the medical file during the medical examination~     organized by the schools after obtaining the informed consent of the students and their~     parents.~   "
6467|NCT03482180|"~     To examine variation rate of Non-HDL with KI1106 comparison Atorvastatin monotherapy.~   "
6468|NCT03482167|"~     This study will provide insight into whether a new dietary supplement that mimics the~     beneficial effects of calorie restriction, reduces arterial stiffness, improves arterial~     function within the brain and restores brain function and memory in patients with~     amnesticmild cognitive impairment. Overall, this project has the potential to identify a~     novel, safe and cost-effective strategy for decreasing age-related memory loss.~   "
6469|NCT03482154|"~     This is a retrospective chart review of patients who underwent a hematopoietic stem cell~     transplant (HSCT) between 1994 and 2016 to evaluate incidence of malglycemia and the~     relationship to specific outcomes.~   "
6470|NCT03482141|"~     The investigator aims to examine the clinical utility of WES, including assessment of a~     variety of health-related and reproductive outcomes in undiagnosed prenatal cases.~   "
6471|NCT03482128|"~     Implementing coagulation management algorithms based on Point-of-care (POC) testing devices~     such as thromboelastography (TEG) or rotational thromboelastometry (ROTEM) have been shown to~     reduce transfusion rates and the occurrence of adverse patient outcomes. Apart from the TEG~     and ROTEM, another viscoelastic POC measurement technique, the SONOCLOT, can be easily used~     at the bedsite. However Information regarding a SONOCLOT based coagulation management~     algorithm however is lacking.~      Transfusion rates of allogeneic blood products (Red blood cells = RBC, Fresh frozen plasma =~     FFP, Platelet concentrates = PLT) and patient adverse outcomes in two cohorts before and~     after the implementation of a SONOCLOT based coagulation management algorithm were evaluated~     on an observational basis in 1754 patients undergoing different types of cardiac surgery. The~     effect of the cohort and 19 predictors on transfusion was assessed by relative R2-values~     obtained by bootstrapping and a hurdle regression model, comprising a binomial and a Poisson~     count component. Association of predictors with post-operative outcomes was assessed with a~     logistic regression model.~   "
6472|NCT03482115|"~     To provide a fine-grained description of the brain network dysfunctions induced by severe~     traumatic brain injury (TBI) or anoxic encephalopathy, that are responsible for the acute~     state of unarousable unawareness, named coma, this trial wants to explore the usefulness in~     this setting of a combined neuroimaging approaches encompassing several up-to-date techniques~     as structural MRI, fMRI and positron emission tomography (PET) scan (neuroinflammation~     ligands).~   "
6473|NCT03482102|"~     This research study is studying a combination of drugs as a possible treatment for~     Hepatocellular Carcinoma or Biliary Tract Cancer.~      The interventions involved in this study are:~        -  Durvalumab~        -  Tremelimumab~        -  Radiation Therapy~   "
6474|NCT03482089|"~     Prostate cancer is the most common male cancer in global, which accounts for 19% of the total~     and poses great hazards to male health. Unfavorable factors including prostatic specific~     antigen (PSA) >20 ng/ml, Gleason score >8, and T3/4 are significantly associated with~     biological recurrence, metastatic progression and poor survival in prostate cancer. In~     clinical T4(cT4) prostate cancer with bladder invasion patients, symptoms of hematuria,~     urinary urgency, bladder outlet and ureteral obstruction, and pelvic pain led to a poor~     quality of life.~      Radical prostatectomy is crucial for the multimodal treatment of prostate cancer, but limited~     proof demonstrated enough advantages of the surgery in T4 tumor with bladder invasion.~     Radical prostatectomy could hardly meet both demands of local tumor control and urinary~     function. Treatment trends suggest that patients with T4 prostate cancer be treated with~     radiotherapy combined with androgen deprivation therapy (ADT). However, surgery enables a~     full pathological assessment of the tumor characteristics and thus a better estimation of the~     risk of recurrence. Cystoprostatectomy offers an option of surgical treatment for T4 prostate~     cancer with bladder invasion，which can well remove the bladder and urethra, decrease the risk~     of positive surgical margins and avoid urination complications.~      There is no consensus regarding optimal treatment of T4 prostate cancer and no evidence of~     oncological outcomes of cystoprostatectomy from clinical trials. A randomized clinical trial~     comparing two multimodal treatment regimens of cystoprostatectomy and radiotherapy for T4~     prostate cancer with bladder invasion is therefore warranted.~   "
6475|NCT03482076|"~     Iron deficiency anemia is a common complication of liver cirrhosis in childern and may~     affects there life this study to improve the outcome of these patients~   "
6476|NCT03482063|"~     The aim of the present study is to evaluate chronic supplementation with Swisse Ultiboost~     Memory + Focus over a 12 week period on memory in individuals with optimal and sub-optimal~     nutrient profiles.~   "
6477|NCT03482050|"~     This is a study of transplantation of Astrocytes derived from human embryonic stem cells, in~     patients with Amyotrophic Lateral Sclerosis (ALS).~      There will be no change in the routine ALS treatment of the patients enrolled into the study.~     Treatment will be administered in addition to the appropriate standard of care treatment.~      The study hypothesis is that transplantation of Astrocyte(AstroRx) cells can compensate for~     the malfunctioning of patients' own astrocytes by restoring physiological capabilities like~     the reuptake of excessive glutamate, reducing oxidative stress, reducing other toxic~     compounds, as well as by secreting different neuroprotective factors~   "
6478|NCT03482037|"~     Study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of Rec~     0/0438 in subjects with neurogenic detrusor overactivity due to spinal cord injury~   "
6479|NCT03482024|"~     The purpose of this study is to assess how fast LY3298176 gets into the blood stream and how~     long it takes the body to remove it in participants with impaired kidney function compared to~     healthy participants.~   "
6483|NCT03481972|"~     Cardiac amyloidosis caused by transthyretin either mutated (in ATTRm amyloidosis) or wildtype~     (in ATTRwt, formerly senile, amyloidosis) is a rare disease but is diagnosed with increasing~     frequency thanks to the availability of non-invasive scintigraphy-based means. Cardiac ATTR~     amyloidosis is characterized by progressive heart failure with a median survival of less than~     4 years, and there is no standard treatment for this disease. It was proved that the marketed~     antibiotic doxycycline (Doxy) disrupts amyloid fibrils in vitro and in animal models~     synergistically with tauroursodeoxycholic acid (TUDCA). Based on these pre-clinical data, a~     clinical trial of Doxy/TUDCA in ATTR Amyloidosis (NCT01171859) was conducted.~      Treatment was well tolerated and was able to prevent progression of cardiac dysfunction.~   "
6484|NCT03481959|"~     Abuse of psychoactive substances is a behavior belonging to the field of risk behaviors that~     begins and takes place during adolescence. These risk behaviors are a major public health~     problem in France and worldwide.~      Cannabis is the first illicit drug consumed by adolescents in France. His experimentation~     progresses rapidly between 11 and 17 years. The relationship between cannabis use and mental~     health has been shown by several studies. In particular Attention Deficit Hyperactivity~     Disorder (ADHD), characterized by attention deficit, impulsivity and disabling motor~     hyperactivity and beginning before 12 years of age (DSM-5), is a major risk factor for the~     consumption of cannabis. ADHD is a common condition (9% of children and 5% of adults), but~     often undiagnosed or untreated. It has been shown that the treatment of ADHD in childhood~     protects the consumption of psychoactive products during adolescence or adulthood. However,~     to our knowledge there is no study showing that treatment with methylphenidate in an ADHD~     patient - not treated - but already a cannabis user, was a positive prognostic factor in the~     decrease in cannabis use.~   "
6485|NCT03481946|"~     The primary objective of this study is to assess the pharmacokinetics in patients with severe~     hemophilia.~      The secondary objective is to assess the pharmacodynamics of BAY1093884 based on tissue~     factor pathway inhibitor activity~   "
6486|NCT03481933|"~     Within the spectrum of fronto-temporal lobar degeneration (FTLD) semantic dementia (SD)~     causes profound language dysfunction. SD damages semantic processing typically in the~     temporal poles (anterior temporal lobes, ATL). It is an early onset disease (often before 65~     years of age) affecting about 4000 patients in France and for which no validated treatment is~     available.~      For several years a growing number of studies have explored the effects of transcranial~     stimulation (TCS) on aphasic patients following stroke. Several studies have targeted~     left-sided language areas and/or homotopical right-sided regions with excitatory or~     inhibitory TCS, respectively, according to the principle of inter-hemispheric inhibition. In~     addition, repetitive multi-day TCS has provided evidence for long-lasting language effects~     (>6 months) presumably linked to stimulation-induced neuroplasticity. Such investigations~     have provided promising results and have demonstrated that the stimulation site is a~     determining factor by showing that stimulation of cortical areas belonging to the language~     network usually results in more convincing effects than stimulating areas outside that~     network. Despite these findings the use of TCS in degenerative language diseases, such as~     primary progressive aphasias including SD, has only been explored in few small cohort studies~     and, surprisingly, they have not targeted language-related cortices.~      This project proposes the application of multi-day repetitive TCS with direct current (tDCS)~     in a large population of SD patients (N=60). It is built on a exploratory investigation of~     our team which has used three single tDCS sessions in a double-blind sham-controlled study.~     Excitatory and inhibitory tDCS to the left and right temporal pole, respectively,~     demonstrated highly significant transient effects (20 min) on semantic processing in 12 SD~     patients, providing 'proof of concept' and the rationale for this project. The aim here~     consists of using repetitive multi-day tDCS for a potential therapeutic outcome leading to~     long-lasting semantic improvement via neuroplasticity. The project is grounded on 2~     hypotheses: i) tDCS to temporal poles (left-excitatory, right-inhibitory) reactivates~     semantic processing in SD, ii) repetitive tDCS during ten days could induce neuroplasticity~     and therapeutic language improvement.~   "
6487|NCT03481920|"~     The purpose of this study is to evaluate the pharmacodynamics, safety and efficacy of PEGPH20~     in combination with Avelumab in adult patients with chemotherapy resistant advanced or~     locally advanced pancreatic ductal adenocarcinoma (PDAC). This is a multi-center, open-label,~     non-randomized trial.~   "
6488|NCT03481907|"~     We have designed a pilot study to investigate the effect and potential utility of topical~     NuvagenTM (collagen powder) on the rate and quality of wound healing in healthy volunteers~     using the punch biopsy method. After inducing an acute full-thickness wound, the rate of~     complete healing of a wound treated with topical NuvagenTM (collagen powder) will be compared~     to the rate of complete healing of a wound treated with primary closure with sutures, the~     current gold standard. Qualification and semi-quantification of histologic and~     immunohistochemical markers will be used to assess the maturity and structural stability of~     the wound bed. Positive findings would suggest that NuvagenTM (collagen powder) may be~     capable of stimulating the healing of acute wounds in a similar or even superior manner to~     primary closure, suggesting collagen powder may be used in place of sutures, and encouraging~     further studies to characterize its therapeutic potential in dermatologic surgery.~   "
6489|NCT03481894|"~     Demonstrate the safety and efficacy of Kabiven compared to standard parenteral nutrition (PN)~     administered via central vein in pediatric patients (2 to 16 years of age) requiring PN to~     meet nutritional needs.~   "
6490|NCT03481881|"~     This is a prospective study of children <21 years of age with the goal of characterizing the~     PK of drugs administered per standard of care as prescribed by the treating caregiver.~   "
6491|NCT03481868|"~     Primary objective : To identify epigenetic dysregulations of in vivo TKI-resisting CML cells~     Hypothesis : An epigenetic dysregulation is involved in the in vivo survival of a CML cell~     subclone despite the use of TKIs~   "
6496|NCT03481803|"~     This is a Phase IIa study sponsored by AzurRx SAS and Syneos Health is a local representative~     sponsor and involves testing of a new medication for the compensation of exocrine pancreatic~     insufficiency (EPI) caused by chronic pacreatitis (CP) and/or distal pancreatectomy. The new~     medication is called MS1819 Spray Dried (MS1819-SD) which is a lipase produced by the LIP2~     gene of Yarrowia lipolytica using recombinant DNA technology.~      The primary purpose of this study is to investigate the safety of escalating doses of study~     drug MS1819-SD in people with chronic pancreatitis. This enzyme has demonstrated an~     appropriate profile to compensate the pancreatic lipase (enzyme) deficiency that is common~     with CP patients. The deficiency in this enzyme can be responsible of greasy diarrhea, fecal~     urge and weight loss.~      The design of the study is open-label, meaning that all eligible participants will receive~     the study drug MS1819-SD. The MS1819-SD dose will increase throughout the study during dose~     escalation visits in each treatment period; study includes a total of four treatment periods.~      The total duration of the MS1819-SD treatment phase is of 48-60 days, The total duration of~     patient participation in the study is of 74-93 days.~      Approximately twelve patients will be enrolled in this study.~   "
6492|NCT03481855|"~     The evaluation of haemodynamic changes is still challenging in clinically relevant situations~     (e.g. in bleeding, septic and postoperative patients) with the conventional monitoring~     routinely used including heart rate and mean arterial pressure. If the arterial pressure~     drops and the heart increases, the haemodynamic state is already decompensated and a therapy~     is at risk being indicated too late.~      Prior to decompensation - still in the state of compensated shock - it would be desirable to~     detect the shock already. The compensated shock is characterized by an occult drop of cardiac~     output and a hypoperfusion of vital organs like e.g. the splanchnic region. Due to these~     pathophysiological characteristics, a therapy would be indicated already in this stadium of~     shock progression.~      The available monitoring tools to detect compensated shock are on the one hand side invasive~     (intravascular catheter), cost-intensive (cost of the catheter systems), or need extensive~     training (echocardiography). Consequently, the implementation of advanced haemodynamic~     monitoring is still low despite the high clinical relevance for the patients.~      It is the goal of this project to evaluate in healthy volunteers the routinely implemented~     technology of photo-plethysmography in its ability to detect haemodynamic changes by extended~     signal analysis of the pulse-contour and the pulse-wave-transit-times in relation to the~     gold-standard echocardiography.~      Secondary goal of this study is to analyse the physiological and haemodynamic changes during~     progressive central hypovolaemia displayed by non-invasive or minimal-invasive monitoring~     devices and associate the changes to each other.~   "
6493|NCT03481842|"~     Background:~      Endometriosis is a chronic gynecological disease with the growth of endometrial tissue~     outside the endometrium. In all its properties, this tissue is similar to the mucous membrane~     of the uterus.~      Types of endometriosis:~      Endometriosis is divided into genital and extragenital. Genital endometriosis is internal and~     external. When the inner is affected by the uterus, with the external - the ovaries, tubes,~     vagina and external genital organs are affected. Extragenital endometriosis can affect~     various organs of the abdominal cavity.~      Drug treatment does not show high effectiveness. Surgery / laparoscopic is currently~     considered the gold standard treatment for this problem, including infertility treatment.~      The purpose of our studies is to achieve substantial results with respect to tolerability,~     safety and clinical efficacy of vaginal suppository ELTA for treatment of the endometriosis.~      Methods:~      Phase I clinical trial to be conducted at Cancer Center to hold under the aegis~     UniversitätsSpital Zürich from May 2018 to September 2018.~      Ninety-four patients with the form of genital endometriosis will take part in the studies.~     The study was approved by the Ethics Committee at the Cancer Institute no C99884.01FH339~   "
6494|NCT03481829|"~     Background:~      Children s weight has increased sharply in recent years. This may put them at higher risk for~     health problems. High blood glucose in a pregnant mother and too much weight gain during~     pregnancy also may have long-term effects on the child s health. Children who become~     overweight or obese during childhood tend to remain so as adults. Researchers want to study~     many risk factors during and after pregnancy, and how these affect a child s development.~     They will also follow the mother s health and well-being after pregnancy.~      Objectives:~      To learn how a pregnant mother s environment, lifestyle, and health conditions may affect her~     child s growth and development from birth until adulthood.~      Eligibility:~      Women 18 and older who are getting prenatal care at Phoenix Indian Medical Center~      Mothers and children who were in the LIFE-Moms Phoenix study~      Design:~      Mothers will have 3 visits during pregnancy.~      In the child s first year, mothers will have 2 visits and their child will have 4.~      Children will have 2 visits in their second year and 1 each year until they turn 18.~      Mothers will have a visit 2 years after birth and 4-5 years later.~      Both the mother and child s medical records will be reviewed. They will have physical exams~     and give blood and stool samples.~      Mothers may give cord blood and placenta samples. They will give breastmilk and urine~     samples. They will fill out questionnaires.~      Children s hair and toenail clippings (and baby teeth that fall out, if possible) will be~     collected. They will have an ultrasound. They may get an activity monitor.~      Mother and child will be followed until the child s 18th birthday.~   "
6495|NCT03481816|"~     Background:~      Metastatic castration resistant prostate cancer (mCRPC) keeps growing even when the amount of~     testosterone in the body is reduced to very low levels. mCRPC is incurable. Researchers want~     to develop vaccines to teach the immune system to target and kill cancer cells. They want to~     test three of these vaccines (ETBX-071, ETBX-061, and ETBX-051) against mCRPC.~      Objective:~      To test the safety of combination ETBX-071, ETBX-061, and ETBX-051 and to study their effects~     on the immune system.~      Eligibility:~      People ages 18 and older with mCRPC that has not responded to standard therapies~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Blood, urine, and heart tests~      CT or MRI scans~      Bone scan~      Participants will get the vaccines as shots under the skin every 3 weeks for 3 doses. They~     may then have the shots every 8 weeks for up to 1 year.~      Participants will keep a diary to record any symptoms from the vaccines.~      Participants will have blood tests each time they get the vaccines. They will also have scans~     and other tests to measure the effect the vaccines have on their tumors.~      Participants will have a visit within 28 days after their last treatment. This includes a~     physical exam and blood and urine tests.~      Participants will then be contacted by phone every 3 months for the first year, every 6~     months for the next 2 years, and every 12 months for another 2 years.~      Participants will be asked to join a long-term follow up study.~   "
6497|NCT03481790|"~     This study evaluates the efficacy and tolerability of lactoferrin in contrast to ferrous~     sulphate in the context of iron deficiency anemia with pregnancy.~      Half of participants will receive lactoferrin, while the other half will receive ferrous~     sulphate.~   "
6498|NCT03481777|"~     Our primary aim is to investigate whether remote ischemic conditioning (RIC) as an adjunctive~     treatment reduce neurological impairment at 24 hours and improve long-term recovery in acute~     stroke patients as an adjunct to standard treatment.~   "
6499|NCT03481764|"~     Febrile seizures (FS) are the most common neurological disorder in chilhood and are a great~     stress for parents due to their dramatic clinical appearance.~      Using HRC-test (test for determination of homozygously recessive characteristics in humans)~     we analyzed presence, distribution, and individual combination of 20 selected genetically~     controlled morpho-physiological traits among FS patients and control to determine a possible~     deviation in the homozygosity level and genetic loads in the group of affected children and~     whether there is a predisposition to the occurrence of FS.~   "
6500|NCT03481751|"~     Crohn's disease (CD) is a chronic inflammatory disease in the gastrointestinal (GI) tract. It~     is characterized by an alternating course between remission and relapse, which necessitates~     subsequent adjustments in medical therapy. Thus, it is important to have suitable tools to~     assess disease activity, and currently the reference standard is using ileocolonoscopy.~     However, ileocolonoscopy causes major patient discomfort and due to logistic reasons, it~     cannot be performed on a regular basis. High frequency ultrasound (US) is a potentially~     useful tool to evaluate changes in disease activity in affected bowel segments. Although~     there are some studies using US in CD patients to construct ultrasonographic scoring systems,~     there are no validated scores in daily clinical practice. In a recent study by Nylund et al,~     we used multiple linear regression to select which simple conventional ultrasound parameters~     that should be included in an ultrasound scoring system (Simple Ultrasound Score of Crohn's~     Disease (SUS-CD)) using endoscopy as a reference (unpublished data). In this study, we aim to~     validate this scoring system using an endoscopic score (Simple endoscopic activity score for~     Crohn's disease (SES-CD)) as reference standard and to assess interobserver variability.~      The scoring system might be a useful supplement to endoscopy to follow up CD patients.~   "
6501|NCT03481738|"~     This study is an observational (ie, non-interventional), longitudinal, multicenter, global~     registry for patients with pyruvate kinase (PK) deficiency, a rare non-spherocytic hemolytic~     anemia.~      This Registry will be open for enrollment for 7 years and all enrolled participants will be~     followed prospectively for a minimum of 2 years, and up to 9 years.~      Data will be collected from participating Registry Physicians, participants, and, where~     appropriate, parents/guardians who have provided informed consent or assent (where relevant)~     and authorization pursuant to applicable laws and regulations.~      Data should include demographic, clinical, and treatment data; and other data of relevance to~     the management of patients with PK deficiency. Annual assessments are strongly encouraged to~     enhance longitudinal understanding of PK deficiency; however, no specific assessments are set~     or required by this Registry protocol.~   "
6502|NCT03481725|"~     Postoperative pain is usually treated with opioids that have undesirable and sometimes~     dangerous side effects (e.g., vomiting and respiratory depression)—and yet over 80% of~     patients still experience inadequate pain relief. A novel, non-pharmacologic analgesic~     technique—percutaneous peripheral nerve stimulation (PNS)— holds extraordinary potential to~     greatly reduce or obviate opioid requirements and concurrently improve analgesia following~     painful surgery. This technique involves inserting an insulated electric lead adjacent to a~     target nerve through a needle prior to surgery using ultrasound guidance. Following surgery,~     a tiny electric current is delivered to the nerve resulting in potent pain control without~     any cognitive or adverse systemic side effects whatsoever. The electrical pulse generator~     (stimulator) is so small it is simply affixed to the patient's skin. The leads are already~     cleared by the US Food and Drug Administration to treat acute (postoperative) pain for up to~     60 days; and, since percutaneous PNS may be provided on an outpatient basis, the technique~     holds the promise of providing potent analgesia outlasting the pain of surgery—in other~     words, the possibility of a painless, opioid-free recovery following surgery.~      The current project is a multicenter, randomized, double-masked, placebo-controlled,~     parallel-arm clinical pilot study to (1) determine the feasibility and optimize the protocol~     of a planned definitive clinical trial; and (2) estimate the treatment effect of percutaneous~     PNS on pain and opioid consumption following moderate-to-severely painful ambulatory surgery~     compared with usual and customary opioid-based analgesia. This will allow determination of~     the required sample size for a subsequent definitive multicenter clinical trial. Combined,~     the pilot study and definitive trial have a strong potential to dramatically reduce or~     obviate postoperative opioid requirements and their resultant negative effects on both~     individuals and society; while concurrently improving analgesia, increasing the ability to~     function in daily life, decreasing the risk of transition from acute to chronic pain, and~     improving quality of life.~   "
6503|NCT03481712|"~     In a cohort of symptomatic patients referred to coronary computed tomography angiography~     (CCTA), the investigators aim:~        1. To investigate and compare the diagnostic precision of Rubidium Positron Emission~          Tomography (Rb PET) and 3 Tesla Cardiac Magnetic Resonance imaging (3T CMRI) in patients~          where CCTA does not exclude significant coronary artery disease (CAD) using invasive~          coronary angiography with fractional flow reserve (ICA-FFR) as reference standard.~        2. To evaluate the diagnostic precision of quantitative flow ratio (QFR) and ICA-FFR in~          patients where CCTA does not exclude significant CAD using Rb PET and 3T CMRI as~          reference standard.~        3. To show superiority for the CADScor®System compared to the Diamond-Forrester score in~          detection of CAD with CCTA and ICA quantitative coronary angiography (ICA-QCA) as~          reference standard.~        4. To study the diagnostic accuracy of computed tomography fractional flow reserve (CT-FFR)~          in patients where CCTA does not exclude significant CAD with ICA-FFR as reference~          standard.~        5. To identify and characterize genetic risk variants´ and circulating biomarkers´~          importance in developing CAD.~        6. To evaluate the bone mineral density in the hip and spine and correlate this to the~          degree of vascular calcification.~   "
6504|NCT03481699|"~     This study evaluates the efficacy of an intervention based on the Implicit Theories of~     Personality (ITP) in Spanish adolescents. Half of participants received the ITP intervention,~     while the other half received an educational intervention.~   "
6505|NCT03481686|"~     In chronic kidney disease, ESAs (Erythropoiesis-stimulating agents) are used to treat anemia.~     This anemia is due to decreased renal production of erythropoietin (EPO), a hormone that~     stimulates the production of red blood cells in the bone marrow. Treatment of anemia~     increases survival, decreases morbidity and improves quality of life and exercise tolerance.~      Self-administration of ASE has been encouraged for many years, notably with pens for~     injection, but only few patients are educated in the injection technique.~      The investigators therefore wish to lead a study in the Nephrology department of Rennes~     University Hospital to educate the patient, or his or her spouse, on ESA injections during~     hospitalization, in order to empower the patient in his care, and with the second aim of~     reducing the costs of chronic renal insufficiency.~   "
6517|NCT03481530|"~     This is a clinical study to examine rates hypoglycemia (self-report, EHR review, and review~     of values from a FDA approved continuous glucose monitoring system (CGMS)). Subjects will~     wear either blinded or unblinded CGMS. This is a 1:1 assignment with one group (50%) wearing~     1 unblinded/1 blinded CGMS and the other group 50% wearing 2 blinded CGMS. The assignment~     will be computer based in a random fashion. Participants will continue with their usual~     diabetes management and glycemic monitoring profile as per usual. Those assigned to an~     unblinded CGMS can use the CGMS to manage their glucose levels at their own discretion.~     Individuals recruited will be those Type 2 diabetes who are deemed to be at high risk for~     hypoglycemia or low risk for hypoglycemia from a point score system established in an~     affiliated study.~   "
6506|NCT03481673|"~     Children with a chronic condition are at a significantly higher risk for anxiety and~     depression than those without a chronic condition. Asthma is the most common childhood~     chronic condition. Children with asthma and co-morbid anxiety and/or depression are at risk~     of poor health outcomes. The purpose of this study is to evaluate the effects of a manualized~     cognitive behavior skills-building intervention on key physical and mental health outcomes in~     8 to 12-year old children with persistent asthma and co-morbid anxiety and/or depression. The~     results of this study will inform a large scale randomized controlled trial to fully test~     this needed intervention.~      COPE (Creating Opportunities for Personal Empowerment), developed by Dr. Melnyk, is a~     manualized intervention that has been implemented with children, adolescents, and young~     adults. COPE is a cognitive behavior skills-building program based on cognitive behavior~     theory. Results from previous studies using COPE have shown consistent decreases in anxiety~     and depression as well as an increase in healthy lifestyle behaviors in youth with elevated~     anxiety and depressive symptoms in inner city and rural settings, youth with obesity, and~     teens experiencing chronic recurrent headaches. However, the COPE program has never been~     adapted and tested with children who have persistent asthma. This study proposes to test an~     adaptation of this evidence-based program, COPE for Asthma, with 8 to 12-year-old children~     with persistent asthma and elevated anxiety and/or depressive symptoms. COPE for Asthma~     combines components of asthma education with cognitive behavioral skills. This novel~     adaptation could fill a gap in research by providing a scalable intervention for this highly~     vulnerable population.~   "
6507|NCT03481660|"~     The purpose of this study is to evaluate the efficacy and safety of brolucizumab in treatment~     of patients with visual impairment due to diabetic macular edema (DME).~   "
6508|NCT03481647|"~     This study will evaluate the effect of an intensified oral care programme on prevalence,~     severity and duration of mucositis in patients undergoing treatment for cancer in the head~     and neck region.~      Patients in the control group get professional oral care once a week.~   "
6509|NCT03481634|"~     The purpose of this study is to evaluate the efficacy and safety of brolucizumab in treatment~     of patients with visual impairment due to diabetic macular edema (DME).~   "
6510|NCT03481621|"~     Vulvodynia is a common condition in women (16%); however, at this time there is no known~     effective non-pharmacological therapy reported. Acupuncture is one complementary and~     alternative medicine therapy used by many patients with vulvodynia; some case reports show~     that acupuncture may be an effective intervention. In recent years, there were some studies~     registered took at like at actual trials of acupuncture on vulvodynia, but either they did~     not reach the trial aims, some studies did not get enough patients or the trial designs mimic~     drug studies and did not reflect acupuncture real characteristics.~      This study evaluates acupuncture for the treatment of vulvodynia; specifically, if it reduces~     vulvar pain, pain duration and pain with intercourse. It also examines how long the effect of~     acupuncture lasts in women with vulvodynia. One third of the women will receive acupuncture~     focused on pudendal nerve distribution area; another one third of the women will receive~     acupuncture focused on traditional meridian points; the other one third of women will use~     standard care (without acupuncture). Women who get a reduction in pain (included in~     subjective and objective scores) will have their pain monitored once a week for up to 6 weeks~     to see if the acupuncture effect lasts.~   "
6511|NCT03481608|"~     A phosphatidylcholine species enriched with lauric acid at both the sn-1 and sn-2 positions,~     dilauroylphosphatidylcholine (DLPC), was recently identified as a ligand for the nuclear~     receptor, liver receptor homolog-1 (LRH-1). To date, DLPC has not been reported in vitro or~     in vivo, and has yet to be catalogued in the human metabolomics database. This intervention~     trial aims to determine the impact of consumption of dietary lauric acid, in the form of~     coconut oil (49% lauric acid), can facilitate the production of DLPC in humans.~   "
6512|NCT03481595|"~     The purpose of this study is to assess the usefulness and results of orthopedic patients~     having access to a cell phone App called HealthLoop to utilize during the postoperative time~     period, compared to patients who have the usual postoperative management. The researchers~     want to investigate whether there any differences in outcomes and satisfaction in patients~     and providers.~   "
6513|NCT03481582|"~     The purpose of the study to evaluate effect of nitroglycerin trans-dermal patches on uterine~     and sub-endometrial blood flow in women with unexplained infertility.~   "
6514|NCT03481569|"~     Nosocomial Central Nervous System infections are difficult to treat and an early appropriate~     therapy can improve prognosis. The two main reasons for treatments failure are the difficulty~     to reach high concentrations of antibiotics (ATB) in CNS because of brain barriers (BB), and~     the emergence of Multi-Drug-Resistant (MDR) pathogens that require high ATB concentrations~     for being killed. Therefore a better knowledge of ATB CNS distribution and PK-PD~     characteristics is essential for efficiency of treatments and to avoid resistance~     progression. Because of BB and cerebrospinal fluid (CSF) turnover, unbound (active)~     concentrations of ATB in CSF are frequently much lower than corresponding plasma~     concentrations, which therefore may not be used to predict efficacy. However except for~     patients with EVD, CSF access is difficult. Overall the litterature about ATB distribution~     within CSF exist but PK-PD publications are rarer. Especially for Broad Spectrum ATB which~     are recommended in case of invasive infection in ICU patients due to MDR pathogens such as~     Acinetobacter baumanii, extended spectrum ß-Lactamase producing (ESBL) pathogens or~     Multiresistant Staphylococcus aureus.~      Furthermore, measuring ATB concentrations within the CSF at certain time-points is necessary~     but not sufficient to predict antimicrobial efficacy. First PK modelling is required to~     describe the full CSF concentrations versus time profiles. Then targets must be obtained from~     literature or determined for the relevant PD index, which may be, depending of the~     antibiotic, Time over Minimal Inhibitrice Concentration (T>MIC), Area Under the Curve over~     MIC (AUC/MIC) or peak concentration over MIC (Cmax/MIC). Eventually Monte-Carlo simulations~     can be conducted to predict the probability of target attainment according to various dosing~     regimens to find the optimal one.~      The goal of this multicenter population PK-PD study is to characterize CSF distribution and~     challenge recommended dosing regimens of 7 ATB indicated in CNS infections (vancomycin,~     daptomycin, ceftazidime, meropenem, colistin, aztreonam, linezolid).~   "
6515|NCT03481556|"~     This is an open-label Phase 1/2a study which will enroll patients that have relapsed or~     relapsed-refractory multiple myeloma following 1-4 lines of prior therapy. Patients will~     receive either melflufen+dexamethasone+bortezomib or melflufen+dexamethasone+daratumumab and~     are required to be PI refractory to be enrolled to the bortezomib regimen, and to not have~     any prior exposure to daratumumab or other antiCD-38 mAb to be enrolled to the daratumumab~     regimen.~   "
6516|NCT03481543|"~     The study aim to evaluate effectiveness of two bronchodilator nebulization strategies in~     patients with acute decompensated type 2 respiratory failure due to acute exacerbation of~     chronic obstructive pulmonary disease..~   "
6518|NCT03481517|"~     Acute appendicitis is one of the most common acute abdomens that need surgical intervention.~     Laparoscopic surgery much decreases postoperative pain of wound, however, pain remains an~     important determinant of recovery after surgery. Intraoperative local anesthetic agent~     infiltrated locally into surgical wound to relieve postoperative pain is a feasible and safe~     method suggested in some literature. However, there is no routine use of this method in~     clinical practice because its benefit is still unknown. Besides, very few evidence could be~     found in literature review. To date, there is still no double blinded, prospective,~     randomized control trial addressing in evaluation of its interest. In this study, the~     investigators aim at investigating the benefit of wound infiltration with local anesthetic~     agent (bupivacaine) for laparoscopic appendectomy in adult. The study design is a double~     blind, prospective, randomized control trial with a 1:1 allocation ratio. A hundred and forty~     adult patients with appendicitis will be included. The control group undergo laparoscopic~     appendectomy without wound infiltration with local anesthetic agent, the intervention group~     undergo laparoscopic appendectomy with wound infiltration with local anesthetic agent~     intraoperatively. The clinical characteristics, outcomes, and patient's satisfaction will be~     recorded and analyzed. The investigators hope this study can provide a high level evidence in~     pain management of patient undergo laparoscopic surgery.~   "
6519|NCT03481504|"~     Background: Chronic pain is a highly prevalent phenomenon with a large impact on the~     individual's wellbeing. Acceptance and Commitment Therapy (ACT) can be used to help patients~     relate to chronic pain in a way that helps improve their quality of life. This paper~     introduces an ACT protocol specific to chronic pain patients: ACT- Exposure and Perspective~     Taking (ACT-EPT). Aspects specific to this therapy are the focus on exposure as a means to~     elicit behavioural and emotional change regarding pain experience and it's format as a~     compact individual therapy.~      Objectives: Investigators conduct a single case experimental study (ABA design) with a~     multiple baseline design, aimed at assessing the effectiveness of the experimental ACT-EPT~     protocol (phase B) compared to usual care (phase A) in individual chronic pain patients.~     Outcomes include the increase of participation in daily life and health related quality of~     life, measured with the Short Form-12 (SF-12). Quantitative results will be combined with~     qualitative results from interviews in a mixed methods design.~      Participants: Five adults with chronic pain referred to a rehabilitation centre (≥18 years~     old).~      Methods: Phases A and B together take 16 weeks for each participant, during which weekly~     quantitative measurements will be taken. The length of the first phase A will be randomised.~     The intervention (phase B) consists of weekly ACT-EPT sessions with a maximum of 3 sessions~     of approximately 90 minutes each. Individual interviews will take place after the last~     quantitative measurements. These focus on two topics: psychological processes of change and~     evaluating the intervention.~   "
6520|NCT03481491|"~     The investigators will study the relationship between the basal ganglia and the cerebellum in~     dystonia by associating cerebellar stimulations with functional magnetic resonance imaging~     analysis.~   "
6521|NCT03481478|"~     Patients with greater tuberosity fractures is becoming increasingly common, as is the number~     of cases of humeral surgical neck fractures. This study investigated the relationship between~     size of greater tuberosity fragment and occurrence of humeral surgical neck fractures by~     using CT or MRI tests.~   "
6522|NCT03481465|"~     This study aims to evaluate, at long-term, the occurrence of liver disease and~     cardio-vascular risk, in a sample of patients diagnosed with first episode of non-affective~     psychosis.~   "
6523|NCT03481452|"~     The present study aimed to determine whether infants disorders of regulation of states are~     associated with perinatal anxiety, and further to explore the efficacy of the behavioral~     intervention in enhancing positive interactions between mothers and their infants and thus~     ameliorating infants' disorders of regulation of states.~   "
6524|NCT03481439|"~     The objective is therefore to create a risk score for ADEs in an orthopedic and~     traumatological surgery department.~      The study is an prospective, observational, cohort trial. A first step will consist of: (i) a~     collection of PIs carried out in an orthopedic and traumatological surgery department for 1~     month, (ii) a score of the clinical impact of Pharmacist Interventions using the Clinical,~     Econnomic and organisationnal scale by method of consensus and (iii) a statistical analysis.~     Statistical analysis consists of (i) logistic regression modeling, (ii) performance~     measurement by discrimination and calibration, and internal validation by resampling. In a~     second step, external validation using a new sample will be performed.~   "
6525|NCT03481426|"~     The study evaluates the effect of workplace interventions on work ability promotion among~     workers with back problems. The half of participant will receive Information, advice and~     guidance for back problems in addition to participatory workplace actions organized by~     Occupational Health Physiotherapist. The other half will receive only Information, advice and~     guidance without workplace intervention.~   "
6526|NCT03481413|"~     Data collection from arrhythmia patients undergoing catheter-based electrophysiological (EP)~     intervention in order to develop a patient specific optimized therapy (PSOT).~   "
6527|NCT03481400|"~     The investigators aim to investigate the incidence of migraine attacks after calcitonin~     gene-related peptide (CGRP) infusion in patients who have tried anti-CGRP monoclonal antibody~     treatment for the prevention of migraine.~   "
6528|NCT03481387|"~     This is a prospective, open, single arm, multi-center clinical study in China. The primary~     objective of this study is to demonstrate the safety and effectiveness of the PERCEVAL S~     heart valve when used to replace a diseased native or malfunctioning prosthetic aortic valve~     in the indicated Chinese population for tissue heart valve replacement and suitable to the~     PERCEVAL S valve.~      The secondary objectives are to collect all relevant device and subject demographics,~     procedural and hospital discharge, short and long-term data, as described in the secondary~     endpoints section.~   "
6529|NCT03481374|"~     testing of autonomic function and relationship with exercise and Qol in diabetic patients and~     controls~   "
6542|NCT03481205|"~     The purpose of this study is to demonstrate the feasibility of performing remote limb~     ischemic conditioning (RLIC) using the Doctormate device, a special blood pressure device~     used to perform RLIC, on patients with acute ischemic stroke due to large vessel occlusion~     being transported to a thrombectomy capable center by the helicopter.~   "
6530|NCT03481361|"~     The primary aim of this study is to assess the relationship between obstructive sleep apnoea~     (OSA) and cardiac autonomic neuropathy (CAN) in patients with T1D.~      The secondary aims of this study are to assess: (1) the prevalence of OSA in patients with~     T1D; (2) the relationship between OSA and metabolic parameters (such as glycaemic control,~     blood pressure, lipids and weight) in patients with T1D; (3) the relationship between OSA and~     diabetes-related microvascular complications (retinopathy, nephropathy, peripheral~     neuropathy) in patients with T1D; and (4) the potential mechanisms for the relationship~     between OSA and diabetic-related complications if such a relationship is found.~   "
6531|NCT03481348|"~     During the course of ALS most patients develop swallowing deficits. In this pilot study we~     investigate if dysphagia in ALS can be improved by Pharyngeal Electrical Stimulation (PES).~     PES is Communauté Européenne (CE-) certificated and has been approved for treatment of~     neurological, oropharyngeal dysphagia. During PES, electrical stimuli are applied at the~     pharynx via a nasogastral tube with the aim of triggering reorganization processes in damaged~     brain structures. There is evidence of a positive effect of PES in Stroke and Multiple~     Sclerosis patients.~   "
6532|NCT03481335|"~     This study aims to evaluate the effectiveness of the Community Health Assessment Program in~     the Philippines (CHAP-P), looking at the differences between communities implementing CHAP-P~     versus communities not implementing CHAP-P.~   "
6533|NCT03481322|"~     The purpose of this study is to evaluate the acceptance of a salt restricted diet cooked with~     a controlled amount of salt in patients with heart disease. Verifying if there is difference~     in the acceptance of the standard and hyposodic diets cooked with controlled amount of salt.~   "
6534|NCT03481309|"~     Investigating modulation of motor cortex excitability by transcranial magnetic stimulation~     and transcranial direct current stimulation.~   "
6535|NCT03481296|"~     The objective of the study is to conduct a randomized controlled trial to determine the~     impact of a multi-level culturally-sensitive decision support intervention on colorectal~     cancer screening adherence among 400 Chinese and Korean American primary care patients.~   "
6536|NCT03481283|"~     Three pieces of information lead to the basis for this study:~        1. Individuals with Type-2 diabetes commonly develop peripheral neuropathy.~        2. Increased production of the hormone amylin occurs in individuals who have Type-2~          diabetes.~        3. Aggregations of amylin was found in the peripheral vasculature of rats that~          overexpressed human amylin.~      The purpose of this study is to determine whether a correlation exists between the amount of~     amylin present in the upper extremities of human subjects with Type-2 diabetes and the extent~     to which symptoms of peripheral neuropathy are expressed in those subjects. The investigators~     will be testing this by initially collecting blood and skin biopsy samples from subjects,~     followed by measuring patient sensation and pain responses to heat, cold, and pressure in the~     upper extremities.~   "
6537|NCT03481270|"~     Reducing racial disparities in health outcomes is a major policy concern in the United~     States. Although there has been recent progress to close the gap, black men continue to~     experience earlier morbidity and mortality from preventable and manageable medical~     conditions, and live on average 4.2 years less than their white male peers. An oft-prescribed~     solution to close this stubborn gap is to increase the diversity of the healthcare workforce.~     Another common policy tool to increase take-up of preventative healthcare services is~     financial incentives. In this randomized evaluation, we will estimate the effects of~     financial incentives and a racially concordant physician on the uptake of preventive health~     services in Oakland, California.~   "
6538|NCT03481257|"~     A total of 50 participants diagnosed with ACS (group A ticagrelor 180mg/d, n=25), group B~     (clopidogrel 75mg + rivaroxaban 5mg/ d, n=25)) were consecutively enrolled and treated with~     study drugs on top of aspirin (100mg/d) for 1 month. VerifyNow® and Global thrombosis test~     were performed at day 2 and 1 month after administration of study drugs. The investigators~     compared aspirin reaction unit (ARU) and P2Y12 reaction unit (PRU), occlusion time (OT) which~     reflects shear stress-induced thrombotic activity, and lysis time (LT) which showed~     endogenous lytic activity between the two strategies at both time points.~   "
6539|NCT03481244|"~     Disseminated Adv infections are associated with high morbidity and mortality in HSCT~     pediatric patients. The most common source of Adv infection after pediatric HSCT is the host~     digestive tract where latent Adv are reactivated after engraftment. We have shown in a~     monocentric study that Adv viral load in stools is a predictive factor of blood infection in~     children with digestive Adv infections. We assume that an early treatment, with antiviral~     drugs, such as cidofovir and brincidofovir, may avoid severe Adv infections and diseases and~     thus that molecular surveillance in stool is a critical factor for the control of Adv~     reactivations.~      The study has two main objectives: (i) confirming the impact of Adv viral load in stools on~     the occurrence of blood infection based on a multicentric prospective cohort study design;~     and (ii) determining the prognostic and predictive factors for efficacy and toxicity of~     antiviral drugs, such as brincidofovir and cidofovir.~   "
6540|NCT03481231|"~     Glioblastoma (GBM) is the most frequent brain tumor. Currently survival is poor and few~     treatments are available. Recent data show that there is no immune privilege of the central~     nervous system (CNS) and that GBM are invaded by effector CD8 T cells, letting us hypothesis~     that GBM growth is dependent of immunosurveillance.~      The aim of this study is to better understand the antitumor immune response against GBM to~     unravel new effectors and immunosuppressive pathways important for the regulation of~     anticancer immunity and to discover new immune activating strategies with the objectives to~     isolate subgroups of GBMs that could benefit from an immunotherapy approach. To achieve this~     goal, GBM tumor samples and a blood sample will be collected during the initial tumor~     resection.~      The sites involved in the recruitment of the patients will be the neurosurgical teams in~     Brussel, Dijon, Nantes and Padova.~   "
6541|NCT03481218|"~     The aims of this study are to examine the differences in the quality of life among~     individuals with type 1 diabetes and individuals without chronic diseases, differences in the~     quality of life among men and women with type 1 diabetes and the differences in the quality~     of life among individuals with good and poor glycaemic control. The relationship between~     personality traits and the management of disease in patients with type 1 diabetes will also~     be examined.~   "
6543|NCT03481192|"~     To identify in patients admitted for Voluntary drug poisoning (IMV) by psychoactive~     substances, T1 predictors of T2 recall of psychiatric interview and care project.~   "
6544|NCT03481179|"~     In this study, it is being investigated if the association between high frequency repetitive~     transcranial magnetic stimulation associated with motor physical therapy reduces spasticity,~     increases upper limb motor function, and quality of life of post-chronic stroke patients than~     motor physical therapy alone. For this purpose, patients included will be submitted to ten~     sessions with active or sham hf-rTMS followed by a protocol of physical therapy.~   "
6545|NCT03481166|"~     The experience of breastfeeding-related pain is common for postpartum women, but is not often~     anticipated as part of the postpartum experience. This feasibility randomized controlled~     trial aims to examine the effectiveness of a nurse-led educational intervention using~     anticipatory guidance among pregnant women wishing to breastfeed on breastfeeding outcomes,~     breastfeeding-related pain, and maternal satisfaction.~   "
6546|NCT03481153|"~     Children and youth are at a greater risk of concussions than adults, and once injured, take~     longer to recover. The increased incidence of sports-related concussion in youth and the~     potentially serious long-term negative impact on their developing brains has enormous~     repercussions. While most young athletes recover within several days, many continue to~     experience symptoms for many months post-concussion. Symptoms are wide ranging and include -~     most notably: headache, sleep disturbances, brain fog, irritability as well as impairments in~     emotion and cognitive function (i.e. attention, memory, concentration, etc.). Yet there are~     no evidence-based intervention studies that have successfully addressed these symptoms. Thus,~     there is an urgent need for improved therapeutic strategies, which promote optimal functional~     recovery in youth concussion.~      Transcranial direct current stimulation (tDCS) is a safe, non-invasive neurostimulation~     technique that can modulate neural excitability in the brain to positively impact cognition,~     behaviour and mood, particularly when combined with a behavioural intervention. Our long-term~     goal is to determine whether exercise combined with neurostimulation improves recovery from~     concussion. However, to our knowledge, the therapeutic potential of tDCS has not been studied~     in youth with concussion. Our objectives are as follows:~        1. To determine the tolerability of a 20-minute session of tDCS in symptomatic youth~          athletes;~        2. To evaluate the association between symptoms and EEG metrics at baseline and following a~          single session of tDCS in symptomatic athletes and compare these associations in~          symptomatic athletes who do not receive tDCS.~   "
6547|NCT03481140|"~     To evaluate the safety and effectiveness of a lysine-derived urethane adhesive (TissuGlu®~     Surgical Adhesive) as a less invasive alternative to surgical drains in the abdominal donor~     site for deep inferior epigastric perforator (DIEP) flap reconstruction.~   "
6548|NCT03481127|"~     The purpose of this study is to understand the feasibility and impact of integrated~     psychological care in outpatient gynecologic oncology clinics with the goal of creating a new~     standard of care. The investigators propose an intervention study comparing patient-centered~     outcomes (assessed by surveys) between women who receive usual care versus integrated~     psychological care. The investigators' objectives are to learn about the process of~     integration of psychological care directly into outpatient gynecologic oncology clinics and~     the impact of such integration on patients' well-being, presentation of symptoms,~     psychological functioning, coping mechanisms, awareness of support services offered, and~     perception of quality of care. As this is a feasibility study, aims are focused on assessing~     patient willingness for psychological intervention in the medical office, provider~     willingness to have psychologist present in clinic, and impact of psychological intervention.~     With such data to warrant further integration and time of psychologists in medical clinics,~     next steps for immediate and long-term projects may include focus on high risk populations,~     specific disease sites, additional provider clinics, more psychologist time spent in~     gynecological oncology clinics, and effectiveness of interventions with higher power. The~     investigators hope the results will serve as preliminary data for an integrated psychosocial~     care model that can be implemented in other oncology clinics.~   "
6549|NCT03481114|"~     The primary objective of this study is to evaluate patient-reported outcomes during and after~     concurrent chemoradiotherapy for locally-advanced non-small cell lung cancer. Patients will~     be randomized to a standard 6-week radiotherapy course or a 4-week radiotherapy course using~     dose-painting based on pre-treatment PET findings.~   "
6550|NCT03481101|"~     Response evaluation with FDG-PET and free circulating DNA in patients with inoperable lung~     cancer of non small cell type during first treatment with chemotherapy or immunotherapy.~   "
6551|NCT03481088|"~     It is a prospective descriptive study to evaluate TMJ disc-condyle-fossa relationship using~     MRI scan following functional appliance therapy in skeletal Class II Division 2 malocclusion~     in adolescent females.~      All records, including MRI scans will be collected at three stages and will be traced for~     various angular and linear measurements to document the alterations within the condyle~     glenoid fossa complex~        1. Stage- I (pre-treatment),~        2. Stage- II (after pre-functional therapy)~        3. Stage-III (After 6-8 months of functional appliance therapy that is after correction to~          Class I molar relation~   "
6552|NCT03481075|"~     This project is aiming at the integration of a biomechanical computer program with a guidance~     code to simulate the endovascular repair (EVAR) procedure of abdominal aortic aneurysm (AAA).~     The computational time associated with finite element simulation generally renders its usage~     impractical for real-time application. Based on data collected during clinical interventions~     and a priori knowledge of AAA and endovascular device mechanical modeling, the investigators~     are proposing a deformable registration between preoperative CT-scans and per-operative~     fluoroscopy that will take into account prior simulations of participant specific EVAR~     procedures. To avoid the computational cost of a full finite element simulation, the~     investigators propose a simplified and real-time compliant repetitive mechanical behaviour~     based on participant specific parameters.~      The results of this research will provide the Canadian industry with the first realistic~     deformable vascular geometry tool for live endovascular intervention guidance. The proposed~     biomechanical modeling can be translated to other vascular intervention procedure by~     adjusting the biomechanical parameters.~   "
6553|NCT03481062|"~     The anatomy and ultrasound image of infraclavicular region was investigated on cadavers and~     healthy volunteers, respectively. Structures，route，position and complications were discussed~     to improve the success rate and safety of central venous catheterization.~   "
30633|NCT03166072|"~     To evaluate health related quality of life (HRQoL) of low-vision patients and their care~     givers undergoing low-vision rehabilitation program (LVRP).~   "
6554|NCT03481049|"~     The investigators will evaluate the efficacy of a 2 various contingency management (CM)~     interventions (High-Magnitude CM, Shaping CM) for treating heavy drinking among individuals~     with serious mental illness and alcohol dependence who are seen within the context of a~     community mental health center setting. Participants will be 400 adults diagnosed with~     serious mental illness and alcohol dependence and those who demonstrate heavy drinking during~     the first 4 weeks will be randomized to receive treatment conditions.~   "
6555|NCT03481036|"~     The Mukh-Mantri Punjab Hepatitis C Relief Fund (MMPHCRF) is a public health initiative for~     prevention and control of hepatitis C in the Punjab state, India. We assessed the efficacy of~     decentralised public health services and safety of 12- or 24-weeks of sofosbuvir (SOF) +~     ledipasvir (LDV) or SOF + daclatasvir (DCV) with or without ribavirin (RBV) in the treatment~     of pediatric chronic hepatitis C.~   "
6556|NCT03481023|"~     This pilot study evaluates the addition of the EnsoETM esophageal cooling device to the~     radiofrequency (RF) ablation procedure in the treatment of atrial fibrillation in adults.~     Half of participants will receive the EnsoETM in addition to RF ablation, while the other~     half will receive luminal esophageal temperature (LET) monitoring during RF ablation.~   "
6557|NCT03481010|"~     Hip dysplasia is a developmental abnormality of the acetabulum (hip socket) that causes~     abnormal stresses inside the hip joint and leads to painful arthritis at a young age. Many~     patients develop painful symptoms in their hip before advanced arthritis occurs.~      The periacetabular osteotomy (PAO) is a surgical procedure that reorients the acetabulum to~     reduce the stresses inside the hip joint. The PAO is very effective at improving symptoms and~     quality of life. However, some patients may have residual symptoms.~      Patients with hip dysplasia frequently have abnormalities such as labral tears identified~     inside their hip joint before surgery with the use of MRI. These abnormalities cannot easily~     be addressed through PAO alone. Hip arthroscopy is a separate, minimally invasive surgical~     procedure that allows the surgeon to access the inside of the hip joint with a small camera~     and address any abnormalities inside the joint.~      At present, it is not clear whether performing a hip arthroscopy at the same time as a PAO~     improves patient outcomes after surgery compared to a PAO alone.~      This research project will randomize patients to receive either a PAO alone, or a PAO and a~     hip arthroscopy at the same time. Patients will be followed for 2 years after surgery.~     Symptomatic differences between the two patient groups will be assessed to determine added~     benefit of the hip arthroscopy.~   "
6558|NCT03480997|"~     The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test~     product to the reference product as measured by increases in FEV1.~   "
6559|NCT03480984|"~     The researchers are trying to determine pain medication consumption in the first 24 hours~     after surgery in patients given the standard continuous infusion of local anesthetic versus~     patients given the same total dose via programmed intermittent dosing. Both groups will~     receive the option of patient controlled pain medication as well as the same dose of~     pre-programmed pain medication. The only difference is the rate of administration: continuous~     vs. hourly intervals.~   "
6560|NCT03480971|"~     A 10 week trial to assess the ability of Tempol to prevent and/or reduce toxicities~     associated with cisplatin and radiation treatment in head and neck cancer patients. Over the~     course of the 10 week trial, mucositis, nephrotoxicity, and ototoxicity will be monitored and~     assessed.~   "
6561|NCT03480958|"~     Postoperative analgesia in breast surgery is a difficult and overworked issue due to etensive~     surgery and complex innervation of the breast. Erector spinae plane block (ESB) is a new~     defined and promising regional anesthesia technique for thoracic analgesia. Main purpose of~     this study is to compare the analgesic effect of ultrasound guided ESB with thoracic~     paravertebral block - the golden standard method for postoperative regional analgesia~     technique in breast surgery.~   "
6562|NCT03480945|"~     Study objective To evaluate the mechanism behind endothelial dysfunction in patients with~     type 2 diabetes in relation to the level of glycaemic control.~      Primary endpoint: Change in endothelium dependent vasodilatation (EDV).~   "
6563|NCT03480932|"~     The primary objective of this pilot trial is to compare the efficacy, measured as sustained~     virologic response (SVR) at least 12 weeks after completion of therapy, across three study~     regimens/delivery modalities: Arm 1 - 4 weeks of sofosbuvir (SOF) + daclatasvir (DAC) +~     pegylated interferon alfa-2a (PEG) delivered using directly observed therapy (DOT); Arm 2 -~     12 weeks of SOF+DAC delivered using DOT; and Arm 3 - 12 weeks of SOF+DAC delivered as per~     standard of care (monthly dispensation with no DOT). Secondary objectives are 1)To compare~     the cost per SVR for each of the three study arms; 2) To compare adherence among persons~     across the three study arms; 3) To evaluate the safety, tolerability and acceptability of~     treatment in the three arms.~   "
6564|NCT03480919|"~     It is common for patients undergoing spinal injections to report anxiety prior to the~     injection. Although sedation, general anesthesia, and medications can be used to reduce~     anxiety, the use of sedative agents during the procedure can increase the risk of spinal cord~     injury. The purpose of this study is to see if receiving acupuncture before a spinal~     injection can effectively reduce patients' anxiety. Only patients who are scheduled to~     receive a spinal injection at this institution will be eligible for the study.~   "
6565|NCT03480906|"~     This study is to evaluate the usability and patient tolerability for microtherapeutic dosing~     of commercially available ocular medication via the Eyenovia microdose delivery system (MiDD)~   "
6576|NCT03480763|"~     This study is designed 1) to evaluate the safety, tolerability, and immunogenicity of V114~     and Prevnar 13™ in healthy adults 50 years of age or older, 2) to describe the safety of~     sequential administration of V114 or Prevnar 13™ followed by PNEUMOVAX™23, and 3) to evaluate~     the immune responses to the 15 serotypes contained in V114 when PNEUMOVAX™23 is given~     approximately 12 months after receipt of either V114 or Prevnar 13™.~   "
6587|NCT03480620|"~     This study will evaluate the sustainability of pain and functional outcomes along with return~     to opioid use in a population of patients that successfully completed a comprehensive~     interdisciplinary pain rehabilitation program. In addition, this study will compare outcomes~     sustainability and return to opioid use between pain program graduates who receive post~     discharge self-management resources consisting of a DVD with videos of recommended~     flexibility practice (standard of care) or access to an online telerehabilitation platform~     that provides patients with access to the flexibility practice videos on a variety of~     telecommunication devices (e.g., computer, smart phone, tablet).~   "
6566|NCT03480893|"~     Rationale: Minimally invasive techniques have gained popularity to decompress lumbar spinal~     stenosis in the elderly. However, high quality evidence based on randomised controlled trials~     are not available.~      Objective: To investigate whether small size interarcuair decompression is more effective~     than conventional laminectomy in patients with intermittent neurogenic claudication caused by~     lumbar spinal stenosis. Study design: Double-blinded multi-centre randomised controlled trial~     Study population: In total 236 patients are to be included. The inclusion criteria are:~     subjects > 40 years of age with at least 12 weeks of complaints of intermittent neurogenic~     claudication based on MRI confirmed of LSS, with sufficient knowledge of the Dutch language.~      Intervention: Small size interarcuair decompression versus conventional laminectomy.~      Main study parameters/endpoints: Primary outcome is the Modified Roland Morris Questionnaire.~     Secondary outcomes are leg pain, back pain and a 6 minute walk test amongst others.~      Nature and extent of the burden and risks associated with participation: based on available~     literature , it is believed that the risks associated with small size interarcuair~     decompression are no greater than that associated with a laminectomy, although these will be~     examined.~   "
6567|NCT03480880|"~     This study was conducted in two parts:~        1. This first part was designed to determine thiopentone dose requirement for induction of~          anaesthesia with and without the use of Bispectral Index monitoring - Participant and~          Care Provider in appropriate study arm blinded.~        2. As a secondary outcome, Bispectral index monitoring was used to observe changes in~          neuronal function in intraoperative period as well as haemodynamic changes~          intraoperatively - Participant and Care Provider blinded.~   "
6568|NCT03480867|"~     Glioblastoma (GBM) is the most common primary brain cancer in adults. Despite surgery,~     conventional radiotherapy, and chemotherapy, the average survival for GBM is 15-16 months.~     Although additional chemoradiotherapy has been shown to increase survival, the majority of~     recur at the original location.~      Despite many efforts to improve the local control by improving surgical techniques,~     increasing the radiotherapy dose or adding newer chemotherapy agents, these attempts have~     failed to show a survival benefit or an improved cancer control. People who are not~     participating in a study are usually treated with surgery followed by radiation (6 weeks~     duration) together with temozolomide (chemotherapy drug) followed by temozolomide alone. For~     patients who receive this usual treatment approach for this cancer, about 4 out of 100 are~     free of cancer growth five years later. Because GBM invades the surrounding normal brain,~     this study is looking into the possibility of minimizing invasion by starting treatment using~     the combination of radiotherapy and chemotherapy prior to surgery. This approach is an~     experimental form of treatment and the diagnosis is based exclusively on imaging and not on~     histology of the tumour tissue, and there is a possibility that your tumor may not be a GB~     but of other origins.~   "
6569|NCT03480854|"~     To establish the first systems level continuous quality improvement (CQI) collaborative for~     multiple sclerosis (MS) in the United States, to conduct benchmarking analyses and~     assessments of geographic variation in MS care quality and value, and study the effect of CQI~     interventions on improvement of selected performance (quality) indicators.~   "
6570|NCT03480841|"~     This project will determine whether an intervention to enhance communication between infants~     and toddlers with developmental disabilities and their depressed mothers can be integrated~     into federally-funded Early Intervention (EI) services. Participants will be mothers with~     depressive symptoms whose children are receiving EI services, along with their EI service~     providers.~      The investigators will conduct a small feasibility trial using the Language ENhancement~     Assessment/intervention system (LENA), a technology-supported language monitoring system,~     with 10 mothers and one of their child's EI service providers. The LENA uses an infant or~     toddler garment with an integrated audiotape system that records adult speech centered on the~     child, child vocalizations, and reciprocal parent-child turn-taking conversations. The LENA~     software produces visual feedback that a mother can use to focus her language interactions~     with her child. They study will follow participants in the LENA with feedback intervention~     over 6 weeks: 5 weeks of LENA data collection (with mothers running the system 1 day/week for~     16 consecutive hours). The investigators will analyze data from measures on LENA~     communication data (adult word count, child vocalizations and conversational turn-taking),~     and measures of child language, maternal depressive symptoms, and child disability profiles.~   "
6571|NCT03480828|"~     This trial enrolled all the adult patients who were mechanically ventilated for more than 48~     hours and met all creteria for extubation. Patients who needed reintubation for upper aiway~     obstruction, neurological or hemodynamic alteration were excluded. The diaphragm ultrasound~     was performed during spontaneous breathing test or pressure support ventilation trial~     measuring the dipahragmatic excursion (DE) and the diaphragm thickening fraction (DTF)~     whithin 24 hours before extubation.~   "
6572|NCT03480815|"~     This is a randomized, controlled study with a 48-week treatment phase to determine the~     clinical efficacy of temperature controlled laminar flow device (TLA, Airsonett™) in the~     patients with severe allergic asthma who are withdrawal of omalizumab therapy~   "
6573|NCT03480802|"~     This study is designed to 1) describe the safety, tolerability, and immunogenicity of V114~     and Prevnar 13™ in pneumococcal vaccine-naïve adults infected with HIV and to 2) describe the~     safety, tolerability, and immunogenicity of PNEUMOVAX™23 when administered 8 weeks after~     receipt of either V114 or Prevnar 13™.~   "
6574|NCT03480789|"~     In the research, we enroll 120 postoperative patients in the ICU and they will be assigned to~     four group: the eye patch group, the Dexmedetomidine(DEX) group, the eye patch+DEX group and~     the usual group. The sleep quality would be evaluated by the EEG monitor and the metabolic~     level, the inflammation and nutrition status would be detected.~   "
6575|NCT03480776|"~     While ASA is not a cancer medication, research suggests that taking ASA reduces the~     probability of getting many types of cancer because of its anti-inflammatory action.~     Inflammation in the ovaries during ovulation is thought to contribute to the development of~     ovarian cancer, and, because ASA is an anti-inflammatory medication, it may help to prevent~     it.~   "
6588|NCT03480607|"~     To assess the efﬁcacy of dexamethasone versus dexmedetomidine as adjuncts to bupivacaine for~     infra-orbital nerve block in infants undergoing cleft lip surgery.~   "
6589|NCT03480594|"~     The investigators plan to evaluate sensitivity and specificity of HP 13C-pyruvate as an~     imaging agent for detection of altered PDH flux in fatty liver.~   "
6577|NCT03480750|"~     Epithelial ovarian cancer (EOC) is the leading cause of gynecological malignancy-related~     deaths worldwide and is a substantial health threat to women. Many patients eventually~     develop chemoresistant relapsed disease and die despite surgery and combination chemotherapy.~     Progress in improving the survival in EOC has been slow, despite significant advances in~     treatment over the past 25 years. Tubal cancer and peritoneal cancer are thought to be~     similar in their origin, characteristics and treatment strategies. Based upon basic and~     animal studies, it is thought that copper chelators overcome platinum resistance. Thus,~     Trientine combined with carboplatin has been used to treat human cancers. The adverse effects~     (AEs) are acceptable in previously heavily-treated recurrent ovarian cancer patients,~     however, the treatment responses are limited. Therefore, here the investigators conduct a~     phase I trial of Trientine®, pegylated doxorubicin and carboplatin to find the dose-limited~     toxicities, and maximal toxicity dosage, and to explore whether the combination is applicable~     in epithelial ovarian, tubal and peritoneal cancers.~   "
6578|NCT03480737|"~     Cognitive deficits occur across the spectrum of adolescent psychopathology and are one of the~     most significant predictors of clinical and functional outcomes. While cognition remains a~     highly understudied and undertreated domain in psychiatry, emerging evidence suggests that~     repetitive transcranial magnetic stimulation (rTMS) and cognitive training may possess~     significant cognition enhancing effects. We have previously shown that cognitive dysfunction,~     particularly executive functioning (EF) deficits, is strongly associated with~     treatment-related outcomes in children with psychiatric disorders. The primary objective of~     this project is to conduct a randomized, single-blind, sham-controlled pilot study~     investigating the added effectiveness of rTMS at the left dorsolateral prefrontal cortex~     (DLPFC) to a novel EF training program in an effort to transiently enhance EF in adolescents~     with psychopathology and working memory deficits. EF task performance will be measured with~     cognitive measures of working memory, inhibition, and flexibility. EF-related neural~     oscillations will be measured with resting-state electroencephalogram (EEG), specifically~     examining fronto-parietal gamma power and theta-gamma coupling. The primary hypothesis is~     that the addition of rTMS to EF training will result in increased EF task performance and~     increased resting-state fronto-parietal gamma power and theta-gamma coupling, with rTMS~     administered prior to EF training producing a stronger effect than rTMS administered after EF~     training. There remains a dearth of available treatments for EF deficits, particularly in~     adolescents. With an expert mentorship team in adolescent psychopathology and~     neuromodulation, this study will test a highly novel and promising combination of brain~     stimulation and skill training to efficiently improve EF (including underlying brain~     activity) in adolescents with EF deficits.~   "
6579|NCT03480724|"~     To evaluate the efficacy of virtual reality analgesia (VRA) for pediatric patients undergoing~     Botulinum toxin injections (BTI) for spasticity management. Patients will be assigned to one~     of three groups; one group of subjects will randomly be assigned to VRA intervention using~     Google Cardboard Virtual reality head- mounted display powered by a iPod touch, a second~     group of subjects will receive VRA with Oculus Rift, and a third group of subjects will~     receive no intervention beyond standard sedation, anesthetic, and/or restraint—this group~     will serve as the control group.~   "
6580|NCT03480711|"~     -  To evaluate prospectively the surgical outcome in terms of intraocular pressure control,~          potential advantages, disadvantages, success rate, complications and bleb morphology of~          this modified trabeculectomy with an extended subscleral tunnel (ESST) in comparison to~          the conventional subscleral trabeculectomy (SST) in management of uncontrolled primary~          open angle glaucoma.~        -  This study will recruit 40 eyes of (40) candidate patients with primary open angle~          glaucoma (POAG) who are indicated for surgery.~        -  The candidate patients will be recruited into 2 equal comparative groups. In group (A)~          20 eyes (20 patients) who will undergo conventional (SST) with intraoperative mitomycin~          C (MMC) (0.03%) and group (B); 20 eyes of 20 patients will undergo trabeculectomy with~          an ESST also with intraoperative adjunctive MMC (0.03%).~   "
6581|NCT03480698|"~     This study investigates the clinical practices, safety and effectiveness of Cerebrolysin in~     routine treatment of patients with moderate to severe neurological deficits after acute~     ischemic stroke.~   "
6582|NCT03480685|"~     A non inferiority trial to determine the capability of optical coherence tomography (OCT)~     imaging to show vessel morphology in comparison to imaging provided by intravascular~     ultrasound imaging (IVUS).~   "
6583|NCT03480672|"~     This trial evaluates the addition of pembrolizumab to standard postoperative adjuvant~     radiochemotherapy in the treatment of patients with locally advanced intermediate and high~     risk head and neck squamous cell carcinoma (HNSCC).~   "
6584|NCT03480659|"~     A central challenge in the fight against breast cancer is how to detect disease in a~     noninvasive manner before it is detectable by imaging methods. Although inroads have been~     made with more sensitive imaging techniques for earlier detection of breast cancer, these~     techniques are limited by the size of lesion that could be detected. Alternatively, several~     blood proteomic biomarkers have been proposed but none offer as of yet sufficient predictive~     power. Consequently, effective non-invasive tools as prognostic indicators and biomarkers of~     breast cancer are urgently needed.~      The purpose of this study is to develop and test non-invasive biomarkers based on methylation~     changes in PBMC and circulated tumor DNA in breast cancer patients.~   "
6585|NCT03480646|"~     This is a two-arm, open label phase 1b/2 with an oral administration of CPI-1205 in~     combination with either enzalutamide or abiraterone/prednisone in male patients with~     metastatic Castration This study is designed to determine the maximum tolerated dose (MTD)~     and recommended Phase II dose (RP2D) based on safety, tolerability, pharmacokinetic, and~     efficacy profiles of CPI-1205 in combination with either enzalutamide or~     abiraterone/prednisone.~      Following determination of MTD and RP2D will proceed to phase 2. Patients in phase 2 will~     receive CPI-1205 at the RP2D in combination with either enzalutamide or~     abiraterone/prednisone.~   "
6586|NCT03480633|"~     This study aims to prospectively evaluate the relationship between serial measurement of~     several biomarkers, such as insulin-like growth factor binding protein 7 (IGFBP7), bone~     morphogenic protein 1 (BMP1), and carboxyterminal propeptide of type-I procollagen (PICP),~     and echocardiographic features of diastolic dysfunction in three groups, including patients~     with heart failure with preserved ejection fraction (HFpEF), heart failure with reduced~     ejection fraction (HFrEF), and patients without a history of heart failure (HF). The~     relationship between these novel biomarkers and one year major cardiovascular adverse events~     will also be evaluated.~   "
6590|NCT03480581|"~     The goal of this study is to determine if training in both the forward and reverse modes on~     the ICARE (motor-assisted elliptical) contributes to improvements in gait and~     cardiorespiratory fitness.~   "
6889|NCT03476668|"~     The researchers aimed to investigate the relationship between the asymmetric dopaminergic~     degeneration and the attentional resources in a group of patients with Parkinson's disease~     (PD).~   "
6591|NCT03480568|"~     12-week study of the efficacy and safety of alirocumab in patients maintained stably on~     hemodialysis or peritoneal dialysis. Measures of cholesterol levels, drug levels, PCSK9~     levels, routine chemistry and cell counts, and biomarkers will be obtained at baseline and at~     weeks 4, 8, 10 and 12 weeks. Safety events will be obtained throughout the study.~   "
6592|NCT03480555|"~     In this study, we will explore the feasibility of doing a randomized controlled trial in our~     Intensive care department, King Abdulaziz Medical City, Riyadh which will test a two-step~     approach to protein intake in which moderate amount is given in the first 5 days followed by~     a step-up to higher protein (with supplementation of whey protein) compared to continuation~     on moderate protein.~   "
6593|NCT03480542|"~     The aim of this study is to document clinicians variation in practice in comparison to~     standard guidelines by the Medical Center's approved Evidence-based Practice (EBP)~     guidelines, policies, and procedures for CVCs, PICCs and HD catheters by way of a structured~     retrospective review of the Electronic Medical Record (EMR) system.~   "
6594|NCT03480529|"~     Several drugs and chemotherapies seem to have an impact on the immunological system. This~     study investigates reports of immunological toxicities, including the International~     classification of disease ICD-10 codes M05, M32, I78 for treatments in the World Health~     Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).~   "
6595|NCT03480516|"~     Tooth decay is one of the most common chronic infectious disease found in children worldwide~     and if left untreated, is rapidly progress. Severe tooth decay in children is not only affect~     child's health and school performance, but also has impact on the family well-being. Oral~     rehabilitation in children requires time, resources and effort of dental specialists, the~     child and parents. Caries is a destructive condition of organic and inorganic components of~     the tooth structures but reversible and most importantly, preventable. Topical fluoride~     therapy, delivered by dentists has been effectively used to speed up the repair process as~     well as to strengthen the surface of intact tooth structure. Topical fluoride is available in~     various preparations. Regular application of sodium fluoride varnish is every three months,~     by far, considered as effective method in preventing new caries, particularly in the~     high-risk children. It has the advantage of containing therapeutic concentration of fluoride~     and ability to flow over and stick to the tooth surface. Whereas silver ion and relatively~     higher fluoride concentration in Silver Diamine Fluoride (SDF) has been shown to be the most~     effective in harden the decay, stop the caries progress and eliminate pathogenic bacteria. It~     can be hypothesize that when use in combination in school children, both reagents might have~     synergistic effect on arresting existing caries as well as preventing new caries.~   "
6596|NCT03480503|"~     Acne vulgaris is a common chronic inflammatory disease of the pilosebaceous unit which is~     characterized by the formation of non-inflammatory open and closed comedones and inflammatory~     papules, pustules, nodules and cysts.~      It is a multifactorial disease that affects mostly adolescent population. Acne appears very~     early in puberty during the preteen years, often before menarche in girls. Because many~     adolescents have acne, it is difficult to predict which individuals are prone to severe~     cases.~      The pathogenesis of acne is complex, with strong evidence supporting the involvement of~     follicular hyperkeratinization, hyperactivity of the sebaceous glands, colonization of~     Propionibacterium acnes and yeast, and inflammation. Although the importance of androgens in~     the pathophysiology of acne has been supported by both clinical studies and experimental~     data, the research evaluating adipokines are very few in patients with acne vulgaris.~   "
6597|NCT03480490|"~     Pleural effusion is the accumulation of excess fluid in the pleural cavity, which results in~     disturbance of the equilibrium between vascular hydrostatic and oncotic pressures. The~     underlying causes of pleural effusion include pleural inflammation or infection, congestive~     heart failure, lymphatic drainage blockage and malignancy.A parapneumonic effusion is a~     pleural effusion associated with lung infection. Early in the course of parapneumonic~     effusion, the pleura becomes inflamed with leakage of cellular elements, protein, and fluid~     into the pleural space, forming the effusion. Subsequent bacterial invasion results in a~     frank empyema, the presence of which often requires thoracentesis.~   "
6598|NCT03480477|"~     Adverse Childhood Experiences (ACEs) have been associated with negative health outcomes, yet~     scant information exists regarding the relationship between ACEs, Pelvic floor disorders, and~     Chronic Pelvic Pain. Pelvic floor disorders (dysfunction of pelvic floor structures) are~     increasingly common in women, negatively affect their quality of life, and certain of these~     are refractory to treatment. Despite scattered reports suggesting an association between~     childhood abuse and specific pelvic floor disorders, the overall association between ACEs &~     the spectrum of pelvic floor disorders is unknown. The investigators' previous work suggests~     that ACEs may be associated with urgency incontinence and work by others suggest ACEs may be~     associated with Interstitial Cystitis/Bladder Pain Syndrome. These reports are few in number~     and comprehensive evaluations of ACEs relative to pelvic floor disorders are lacking. The~     investigators long-term objective is to investigate the relationship between ACEs in patients~     in the Urogynecologic and Chronic Pelvic Pain population by understanding the contributions~     to the development of their symptomatology. The current Urogynecology study's Primary Aims~     are to--1a) Describe the overall prevalence of ACEs, frequency and type of ACEs in a~     population of women with pelvic floor disorders 1b) Describe differences in ACE prevalence~     compared to the general population. Secondary Aims are to—2a) Describe ACE types/domains of~     controls relative to specific pelvic floor diagnoses 2b) Describe their relationship with~     pelvic floor disorder symptom severity. The investigators central hypothesis is that ACEs are~     common in women with pelvic floor disorders, that ACE frequency varies by pelvic floor~     diagnoses, and that ACEs may have profound effects on adult women's quality of life and~     responsiveness to treatment. The Chronic Pelvic Pain aims, are to 1a) describe the prevalence~     of ACEs in women with chronic pelvic pain. 1b) To compare the prevalence of ACEs in chronic~     pain patients to controls. Secondary aims are to 2a) compare the frequency and ACE~     type/domain of controls relative to chronic pelvic pain patients. 2b) Describe their~     relationship to depression/anxiety and symptom severity.The positive outcome of this~     prospective, cross-sectional cohort study will be its description of ACE prevalence in women~     with pelvic floor disorders and Chronic Pelvic Pain.~   "
6599|NCT03480464|"~     The aim of this study is to investigate the effect of using new app-based technology to~     increase the level of physical activity, compared to conventional postoperative information~     given to patients undergoing bariatric surgery. The hypothesis is that the intervention, i.e.~     using the new technology, will have a greater positive effect on levels of physical activity~     and outcomes of weight loss than conventional postoperative information.~   "
6600|NCT03480451|"~     Idiopathic pulmonary fibrosis (IPF), a chronic fibrotic lung disease of unknown cause, is~     characterized by relentless progression, with a three-year mortality of up to 50%. IPF has~     high morbidity, with 90% of patients reporting dyspnea at the time of diagnosis and this is~     strongly correlated with quality of life and mortality. As IPF progress, breathlessness~     worsens, physical functional capacity declines, and health-related quality of life~     deteriorates. Pulmonary rehabilitation (PR) can improve well-being in patients with other~     chronic lung disease, but little is known regarding PR in IPF.~   "
11197|NCT03420248|"~     The primary purpose of this study is to compare pain after uterine artery embolization using~     non-spherical polyvinyl alcohol particles or tris-acryl gelatin microsphere in patients with~     symptomatic fibroids~   "
6602|NCT03480425|"~     A study of a new approach to determining if, following endotracheal intubation, the~     endotracheal tube (ETT) is in the trachea or the esophagus, and if in the trachea, it is at~     the correct depth. The test for correct placement consists of inflating the cuff to a~     pressure (to be determined by the study) and tugging the ETT gently up and out of the mouth.~     The investigators hypothesize that if it is in the esophagus, it will slide easily all the~     way out; if in the trachea, the cuff will be impeded by catching on the lower surface of the~     cricoid ring, and that this can be felt by the person tugging.~   "
6603|NCT03480412|"~     Reduced ovarian reserve and the consequent poor ovarian response are very recurent in~     infertile patients, indeed a percentage of 10%-24% of couples addressed to infertility~     program may be classified as Poor Ovarian Responder (POR).~      Objective: To evaluate whether the repeated luteal phase stimulation (Second Step) permits a~     significantly higher number of oocytes retrieved in POR when compared to conventional~     follicular stimulation.~      Interventions: The follicular phase stimulation is conduced according to a standardized~     Antagonist protocol or Short protocol (with GnRH agonist) using recombinant or urinary~     gonadotropins (starting dose 300 or 450 UI) or a long lasting recombinant gonadotropin~     (Corifollitropin alfa 150 mcg).~      Two - six days after the first oocyte retrieval a second gonadotropin stimulation will be~     started with a GnRH antagonist protocol (the stimulation will be started with 250 UI of human~     menopausal gonadotropin (hMG) and a GnRH antagonist (GnRH-an) 0,25 mg\die will be~     administered when the leading follicle is ≥ 14 mm until hCG (human chorionic gonadotropin)~     criteria are met. When at least two follicles had reached 17-18 mm in diameter, ovulation~     will be triggered with a single subcutaneous bolus of urinary human chorionic gonadotropin~     (10.000 UI ) and oocyte retrieval will be performed after 35 hours.~      Two or Three months after the second oocyte retrieval the Embryo transfer (ET) will be~     performed after endometrial preparation with Estradiol Valerate and intramuscular~     Progesterone.~   "
6604|NCT03480399|"~     No prospective data exist about long term morbidity and quality of life after multivisceral~     surgical resection for retroperitoneal soft tissue sarcoma (RSTS).~      In order to assess the safety of this surgical approach and the effect on the Quality of Life~     over the long period we propose a prospective observational study.~      The hypothesis is that the surgical treatment has no significant impact in determining a~     lower Quality of Life in the long term.~      Objectives Primary objective Estimate the difference between baseline and 4 and 12 months~     scores of the global health status / QoL scale in patients primarily treated for localized~     RSTS, as determined in QLQ-C30 version 3.0.~      Secondary objectives~        -  Evaluate the long term morbidity of aggressive surgical approach to RSTS in terms of~          renal failure.~        -  Evaluate the difference between baseline and 4 and 12 months scores of DN4 / LEFS / BPI~          questionnaires.~        -  Evaluate the difference between baseline and 4 and 12 months scores of the following~          scales from QLC-C30: PF2, RF2, EF, CF, SF, FA, FI.~        -  Evaluate the difference between baseline and 4 and 12 months scores of the following~          scales and single items from QLC-C29: Blood and mucus in stool, Stool frequency, Sexual~          interest, Impotence, Dyspareunia.~        -  To correlate the surgical resection pattern (number and type of organs resected) and the~          tumor features (size, grading and histological subtype) with the long-term morbidity and~          quality of life.~      Eligibility Inclusion criteria~        -  Adult patients (age > 18 years) with primary localized RSTS surgically treated at our~          institution~        -  Written, voluntary, informed consent~      Exclusion criteria~      - Recurrent disease~   "
6605|NCT03480386|"~     While pulmonary rehabilitation provides benefits to people with COPD, only 1.5% have access~     to pulmonary rehabilitation each year. The main barriers are related to travel and~     transportation. This protocol will evaluate the effect of a home-based rehabilitation system~     on quality of life and steps. The system allows for monitoring by a health care system. A~     health coach will review the data and provide coaching to facilitate behavioral change and~     self-efficacy.~      Patients will be randomized to 1 of 2 groups.~   "
6606|NCT03480373|"~     Aim 1: To compare the overall toxicant exposure in pregnant women who use electronic~     cigarettes (e-cigs, vapor, e-liquid, e-juice, vape, vaping devices) compared to women who~     smoke conventional cigarettes.~      Aim 2. To compare toxicant exposure and birth outcomes among infants born to pregnant women~     who use e-cigs compared to women who smoke conventional cigarettes.~      Aim 3. To explore potential mechanisms by which e-cigs could influence birth weight.~   "
6607|NCT03480360|"~     The standard Johns Hopkins' regimen will be used in study subjects, with the use of donor~     peripheral blood stem cells, rather than marrow. Clinical outcomes will be defined while~     focusing efforts on immune reconstitution focusing on immune checkpoint regulators after a~     related haploidentical stem cell transplant.~   "
6608|NCT03480347|"~     Most existing medical research has focused on patients with well-established COPD and poor~     lung function. Whilst this is important because such patients have lots of symptoms and~     problems, in some respects a better way of reducing health problems in the future would be to~     develop a strategy which focuses on patients with milder disease, and identifies which ones~     will go on to develop more severe problems and why these problems occur. The research in this~     application is designed to investigate these issues.~      The main objective of the Partnership is to study the very early stages of the development of~     COPD. The investigators will do this by recruiting a novel cohort of smokers (age 30-45), in~     whom the investigators will follow the trajectories of lung function decline to identify~     prospectively those at risk of excess decline. This programme forms a unique UK consortium of~     8 academic centres with excellent high quality publication records and broad experience in~     mechanistic, translational, clinical and epidemiological studies in COPD with key~     capabilities including primary care.~   "
6609|NCT03480334|"~     The aim of the trial is to improve efficacy of nivolumab in patients with relapsed or~     refractory HL who recently progressed on anti-PD1 therapy. Nivolumab is highly effective and~     well tolerated in rrHL, nevertheless CR-rates are low and a considerable proportion of~     patients suffers from progressive disease. Localized RT induces an immunogenic effect which~     might work synergistically and facilitate augmented systemic (i.e. abscopal) responses in~     combination with nivolumab.~   "
6610|NCT03480321|"~     The study is designed to evaluate the bioequivalency between the test formulations of~     extended-release tablet of cilostazol (PMR) administered once-daily and the reference~     formulation of immediate-release tablet of cilostazol (Cilostazol) administered twice-daily~     in normal healthy male and female subjects under fasting conditions.~   "
6612|NCT03480295|"~     Eligible patients underwent evaluation of ocular surface parameters by Ocular Surface Disease~     Index (OSDI) and Glaucoma Symptom Scale (GSS) questionnaires, Break Up Time test (BUT),~     Schirmer I test, corneal and conjunctival staining (Oxford scale) and conjunctival in vivo~     confocal microscopy (Heidelberg Retina Tomograph 3, Heidelberg Engineering Gmbh, Heidelberg,~     Germany). After the baseline visit, patients were randomized to use a PF ophthalmic solution~     containing HA 0.4% and TAU 0.5%, QID, in both eyes (Group 1) or to use a PF ophthalmic~     solution containing HA 0.2%, QID, (Group 2) in addition to the ongoing preserved hypotensive~     treatment. Follow-up visits were scheduled at 30 and 90 days.~   "
6613|NCT03480282|"~     Guidelines recommend not screening adults with <10-year life expectancy for cancer; however,~     primary care physicians feel uncomfortable talking to older adults about prognosis. The~     investigators aim to determine whether providing PCPs with scripts on patient prognosis and~     older adults with information on their prognosis would be useful when recommending stopping~     cancer screening.~   "
6614|NCT03480269|"~     assessment of very rapid virological response and rapid virological response as predictors of~     response to sofosbuvir and daclatasvir in treatment of cirrhotic and non-cirrhotic patients~     with HCV, eligible to treatment.~   "
6615|NCT03480256|"~     The aim of the study is to assess the safety and tolerability of SHR6390 combined with~     pyrotinib in the patients with Her-2 positive advanced gastric cancer.~   "
6616|NCT03480243|"~     The purpose of this study is to evaluate and compare the Pharmacokinetics (PK) of concomitant~     administration of Padsevonil (PSL) in the presence and absence of erythromycin in healthy~     study participants.~   "
6617|NCT03480230|"~     The purpose of this study is to assess the response rate to neoadjuvant Compound 121564 plus~     platinum doublet chemotherapy in patients with early stage non-small cell lung cancer.~   "
6618|NCT03480217|"~     The goal of this study is to use a cluster-randomized design (1:1 ratio) among 8 primary care~     clinics affiliated with New York-Presbyterian Hospital to test the effectiveness of a~     theory-informed multifaceted implementation strategy designed to increase the uptake of the~     2015 United States Preventive Services Task Force (USPSTF) hypertension screening guidelines.~     The primary outcome is the ordering of out-of-office blood pressure testing, either~     ambulatory blood pressure monitoring (ABPM) or home blood pressure monitoring (HBPM), by~     primary care clinicians for patients with newly elevated office blood pressure (BP), as~     recommended by the 2015 guidelines.~   "
6619|NCT03480204|"~     This study evaluates the feasibility and usability of a wearable patch as a cardiac monitor~     for non-ICU hospitalized patients.~   "
6620|NCT03480191|"~     Pneumococcal meningitis is an infection of the membrane that covers the brain. It is a~     serious infection which is currently treated with a combination of corticosteroids~     (dexamethasone) and 3rd generation cephalosporins. Nevertheless, complications associated~     with meningitis are relatively frequent and severe. Recent animal studies have shown that~     another antibiotic, daptomycin, can reduce the mortality and long-term effects of~     pneumococcal meningitis. Daptomycin is widely used worldwide in humans for other diseases,~     with few side effects.~      This study aims to evaluate the effect of daptomycin on the proliferation of the bacterial~     infection, and therefore on inflammation. Daptomycin will be added to the currently~     recommended treatment with the same dosage used for other diseases.~      Roughly 130 patients with suspected pneumococcal meningitis admitted to the emergency~     departments of hospitals throughout France will be asked to participate in this study.~      The participation period will last approximately 3 months.~   "
6621|NCT03480178|"~     This study evaluates the renal anemia refractory to Epo . in hemodialysis patients. all of~     participants will receive Epo. and identify various factors contributing to etiology of renal~     anemia in Epo- resistant patients.~   "
6622|NCT03480165|"~     This clinical trial aims to investigate the efficacy of 20 mg Parecoxib when it is given as~     an addition to 20 ml 0.75% ropivacaine in patients receiving ultrasound-guided~     supraclavicular brachial plexus block prior to the upper limb surgeries. It is hypothesised~     that the addition of parecoxib to ropivacaine will provide superior sensory and motor~     blockades to those who only received 0.75% ropivacaine.~      Eighty six (n=86) patients were randomised in one-to-one ratio to either receiving 20 mg~     parecoxib and 20 ml 0.75% ropivacaine (n=43) or 20 ml 0.75% ropivacaine and 1 ml 0.9% saline~     (n=43). The primary efficacy outcomes of interest are a) The time to onsets of sensory and~     motor blockades (measured in minutes); b) The time to recovery from sensory and motor~     blockades (measured in hours). The secondary efficacy outcomes of interest are a) The~     presence of complete sensory blockade at 30 minutes post intervention (recorded as a binary~     yes-no categorical variable); b) The presence of complete motor blockade at 30 minutes post~     intervention (recorded as a binary yes-no categorical variable).~   "
6623|NCT03480152|"~     Background:~      Exome sequencing can identify certain gene mutations in a person s tumor. This can then be~     used to create cancer treatments. In this study, researchers will make a treatment called an~     mRNA vaccine. The vaccine might cause certain tumors to shrink.~      Objective:~      To see if the mRNA vaccine is safe and can cause metastatic melanoma or epithelial tumors to~     shrink.~      Eligibility:~      People 18 70 years old with metastatic melanoma or epithelial cancer~      Design:~      Participants will be screened under protocol 99-C-0128.~      Participants will provide samples under protocol 03-C-0277:~      Participants will provide a piece of their tumor from a previous surgery or biopsy.~      Participants will have leukapheresis: Blood is removed through a needle in one arm and~     circulated through a machine that takes out the white blood cells. The blood is then returned~     through a needle in the other arm.~      Participants will have many tests:~      Scans and x-rays~      Heart and lung function tests~      Blood and urine tests~      Participants will receive the mRNA vaccine every 2 weeks for up to 8 weeks. They will get the~     vaccine as an injection into the upper arm or thigh. They may receive a second course of~     vaccines if the study doctor determines it is needed.~      Participants will have follow-up visits approximately 2 weeks after their final vaccine, then~     1 month later, then every 1 2 months for the first year, and then once a year for up to 5~     years. Each visit may take up to 2 days and include:~      Physical exam~      Blood tests~      Scans~      Leukapheresis at the first visit~   "
6890|NCT03476655|"~     The purpose of this study is to describe the effectiveness (overall response rate [ORR] and~     time to progression [TPP]) of Ibrutinib therapy in participants with chronic lymphocytic~     leukemia (CLL) and mantle cell lymphoma (MCL).~   "
6624|NCT03480139|"~     Objective: To study the natural history of normal pregnancy and the most frequent pregnancy~     complications responsible for the excessive rate of perinatal morbidity and mortality, in~     order to develop models to predict the occurrence of these complications of pregnancy at the~     earliest possible time. The study focuses on the prediction of preterm labor with intact~     membranes, preterm prelabor rupture of membranes (PROM), preeclampsia, small for gestational~     age, gestational diabetes, and fetal death. These complications account for a minimum of $30~     billion annually in the US alone.~      Study population: A cohort of pregnant women seeking care at the prenatal clinic of the~     Perinatology Research Branch in Detroit, Michigan.~      Design: A prospective observational cohort study of the natural history of women with a~     normal pregnancy, a history of adverse outcome, or those with a complication in the index~     pregnancy; therefore, this study will include nulliparous and parous women. Data will be~     collected at the time of clinic visits and will include interviews, clinical measurements,~     and ultrasound studies. We will assemble a biorepository of maternal biological fluids~     (blood, urine, saliva, cervicovaginal fluid, gingival crevicular fluid, swabs to characterize~     microbiota, amniotic fluid when a clinically indicated amniocentesis is performed). Placentas~     will be collected at the time of delivery as well as umbilical blood, and swabs to~     characterize the neonatal microbiota. We will use a retrospective case control and~     case-cohort design to generate models for the prediction of the most common pregnancy~     complications. These models will be developed by classifying obstetrical complications~     according to clinical presentation and histologic placental lesions. Models will be developed~     and subsequently validated in an independent cohort.~      Outcome measures: The goal is to develop sensitive, specific, and parsimonious predictive~     models to identify the patients at risk for developing complications of pregnancy using a~     combination of clinical and biological markers (biochemical and biophysical).~   "
6625|NCT03480126|"~     The project goal is to identify if herbal teas consumed 3 times per day over a period of~     three months can improve these markers of bone health as well as improve QOL compared to~     women taking placebo by increasing osteoblast activity, decreasing osteoclast activity,~     increasing nocturnal melatonin levels and by decreasing CRP and cortisol levels. Our central~     hypothesis is that these herbal teas will improve both objective and subjective measures of~     bone health in an osteopenic population not taking this regimen by reducing osteoclast~     activity and increasing osteoblast activity and by reducing stress and anxiety.~   "
6626|NCT03480113|"~     The present study will carry out a workplace health promotion via MBI to help smoking workers~     to quit smoking.~   "
6627|NCT03480100|"~     The goal of this non interventional study is to investigate the efficacy, tolerability and~     safety of the newly developed Ectoin Nasal Douche END01. Within the study, END01 will be used~     as concomitant therapy in addition to the use of a Xylometazoline-containing decongestant~     nasal spray.~      It will be investigated if the dosis of the used decongestant nasal spray might be reduced,~     the development of the disease might be positively influenced and/or the potentially occuring~     side effects (e.g. dryness of the nasal mucosa, sneezing) might be alleviated by using the~     Ectoin Nasal Douche as concomitant therapy.~   "
6628|NCT03480087|"~     Treatments-related cardiotoxicity is a critical issue in long term lymphoma survivors,~     particularly at young age, and its early identification is important to prevent clinically~     relevant cardiac events. Complete echocardiographic assessment including 2-dimension global~     longitudinal strain (2D-GLS), seems to be an effective tools in detecting preclinical~     systolic changes to the cardiac function even when the ejection fraction is preserved. The~     aim of Cardiocare study is to investigate early detection of subclinical chemo and~     radiation-induced changes in left ventricular function using 2D-GLS.~   "
6629|NCT03480074|"~     The purpose of the study is to compare the results of three standard of care surgical methods~     [stapling versus selective suture ligation (cut, then sew) versus single suture ligation~     (sew, then cut) of the dorsal venous complex (DVC)] during robotic prostate surgery to see~     which is better for the patient's recovery.~   "
6630|NCT03480061|"~     Anesthesia is a drug induced, reversible, comatose state that facilitates surgery and it is~     widely assumed that cognition returns to baseline after anesthetics have been eliminated.~     However, many patients have persistent memory impairment for weeks to months after surgery.~     Cardiac surgery appears to carry the highest risk of postoperative cognitive dysfunction~     (POCD). These cognitive deficits are associated with increased mortality, prolonged hospital~     stay and loss of independence. The investigators propose to investigate the role of~     Dexmedetomidine (DEX) in preventing long-term POCD after cardiac surgery and enhancing early~     postoperative recovery. It is anticipated that DEX will be the first effective preventative~     therapy for POCD, improve patient outcomes, and reduce length of stay and healthcare costs.~   "
6631|NCT03480048|"~     This study, in African American mothers in Detroit, will test an intervention that combines~     home visiting by experienced peer counselors with a smart phone-based weight control program.~     The investigators are trying to help mothers breastfeed their babies longer, and also help~     them get back to the weight they were before they were pregnant. This trial will help the~     investigators to guide policies in the state of Michigan and has the potential to improve the~     health of both mothers and babies everywhere.~   "
6632|NCT03480035|"~     If the patients's teeth are weak or the mouth dose not open well, the lightwand is a useful~     device when endotracheal intubation is necessary.~      Therefore, if the appropriate position of the light beam is determined and the distance of~     the light source suitable for intubation using the lightwand is obtained from anatomical~     structures such as thyroid cartilage and cricoid cartilage, it is clinically useful. Because~     it can prevent unnecessary deep insertion or shallow insertion that can cause damage to~     anatomical structures during intubation.~   "
6633|NCT03480022|"~     There is a growing need to develop pharmacologic interventions to improve metabolic function~     in women with polycystic ovary syndrome (PCOS). Given that PCOS is a frequent condition and~     weight loss is essential but difficult to achieve, it is important to study if the effect on~     body weight reported in other studies can be confirmed in a selected population of~     hyperandrogenic patients, especially with medications currently approved for weight~     reduction. High dose liraglutide alone results in significant weight reduction in obese women~     without PCOS. There is limited data on weight loss with high dose liraglutide in non-diabetic~     females with PCOS treated with this agent . Studies on the effect of anti-obesity medication~     combined with lifestyle changes on body weight and composition and androgen excess in obese~     women diagnosed with PCOS are lacking. The investigators aim to elucidate the most~     efficacious weight reduction regime in obese PCOS women. The investigators further hope to~     determine which treatment(s) addressing the multifaceted disturbances of this disorder in~     patients with PCOS and obesity emerges as the preferable therapy.~   "
6634|NCT03480009|"~     This study evaluates dextromethorphan as a non-opioid adjunctive medication for pain control~     during medication abortion. This is double-blinded, four-arm randomized controlled trial~     enrolling 156 women over a period of 9-12 months: Receiving narcotics+dextromethorphan,~     narcotics and placebo (microcrystalline cellulose), no narcotics and dextromethorphan and no~     narcotics and placebo (microcrystalline cellulose).~   "
6635|NCT03479996|"~     BACKGROUND:~      Compare the pain intensity after TVT-O procedure in the inner part of the thigh where the~     anesthetic substance will be injected versus the inner part of of the thigh without~     anesthetic injection in the same woman.~      The advantage of this work is that this method of testing neutralizes the effect of pain~     thresholds of different women.~      If an advantage will be found in injecting anesthetic as a reduction in postoperative pain,~     it could be recommended for all women who undergo surgery of this kind.~      METHODS:~      Preoperative women will be offered the opportunity to participate in the study after a~     detailed explanation of the study and determine a date for an elective TVT-O procedure. After~     signing the Informed Consent Form, they will undergo a TVT-O procedure with injection of~     anesthetic into one of the obturators membranes. In a random order, Marcaine 5-ml will be~     injected into a left or right obturator membrane.~      One side with Marcaine (Bupivacaine HCL) 0.5% 5 mg / mL Injection,opposite side without~     injection of any anesthetic.~      Before and after surgery, patients will receive Visual Analogue Scale (VAS) instruction and~     will be polled at the following time points: 1,6,12,24 hours after surgery per inner part of~     the thigh separately. Each patient will rate the intensity of the pain she feels on the pain~     questionnaire at each of the time points mentioned before.~   "
6636|NCT03479983|"~     This study evaluates the efficacy of a fresh fruit extract of Indian Gooseberry (AMX160) for~     the attenuation of increased blood cholesterol, LDL cholesterol and triglycerides in patients~     with hypercholesterolemia.~   "
6637|NCT03479970|"~     In the present study the investigators aim to analyze the performance in a battery of social~     cognition tests of subjects with traumatic brain injury.~      On the other hand, the effectiveness of a computerized rehabilitation program designed to~     improve these deficits will be tested, as well as the relationship between social cognition~     and executive functioning.~   "
6638|NCT03479957|"~     Supervised exercise is an essential component of contemporary center-based cardiac~     rehabilitation (CR) programs. Despite the proven effectiveness, uptake and adherence to~     supervised exercise-based CR (exCR) remains suboptimal (approximately 50%), especially in~     rural and remote areas of Sweden. The main reasons for low participation rate in centre-based~     exCR are different accessibility barriers i.e. long distances, transportation problems or~     employment commitments. In this randomised clinical trial, the overall aim is to evaluate the~     effectiveness of, home-based, remotely monitored and coached exCR using the REMOTE-CR system~     compared to home-based exCR based on individualized information regarding current exercise~     recommendations but without monitoring and coaching (usual care) to improve exercise~     capacity. Our hypothesis is that remotely monitored and coached exCR will improve exercise~     capacity to a greater extent than home-based exCR without monitoring and coaching (usual~     care).~   "
6639|NCT03479944|"~     The purpose of this study is to evaluate cumulative dissipated energy (CDE), endothelial cell~     loss, and average torsional amplitude with combination of LenSx® and Centurion® compared to~     conventional cataract surgery.~   "
6640|NCT03479931|"~     The aim of this study is to compare the incidence of catheter associated culture-based~     urinary tract infection (UTI) after elective CD with or without preoperative placement of a~     urinary catheter.~   "
6641|NCT03479918|"~     Purpose: to evaluate an efficacy of chemotherapy regimens R-DA-EPOCH-21 and R-BL-04 with and~     without autologous hematopoietic stem cells transplantation (auto-SCT) in newly diagnosed~     patients with High-Grade B-cell Lymphoma Double-hit and High-Grade B-cell Lymphoma Not~     Otherwise Specified.~   "
6642|NCT03479905|"~     It is standard practice in the United States and many parts of world to perform~     Gastrointestinal endoscopy with the patient under deep intravenous sedation. Obesity is~     accepted as a patient specific risk factor for hypoxic events during procedural sedation for~     GI endoscopic procedures. The obese population has a higher prevalence of obstructive sleep~     apnea (OSA), which is characterized by repeated obstruction of the upper airway, and leads to~     apnea and desaturation. This prospective, randomized study was designed to compare the~     effectiveness of the high flow nasal cannula, standard nasal cannula and standard face mask~     in morbidly obese patients with a high risk of sleep apnea, (BMI greater than 40, STOPBANG~     greater or equal to 5) receiving deep intravenous sedation during colonoscopies. This study~     will assess which method leads to a lower incidence of intraoperative desaturation events~     compared to the current standard of care.~   "
6643|NCT03479892|"~     This study looks at a new study medicine for weight control in people with overweight or~     obesity. The aim of this study is to see if the study medicine is safe for people to take.~     The study also looks at how fast the body removes the study medicine. The participants will~     either get NNC0194-0499 (the study medicine) or placebo (a formula that looks like the~     medicine but does not have active ingredients). Which treatment the participants get is~     decided by chance. The participants will get 1 or more injections into the skin of stomach~     area once each week for 12 weeks. The study will last for about 4 to 5 months. The~     participants will have 18 visits to the clinic.~   "
6644|NCT03479879|"~     To compare the effectiveness of estradiol pretreatment with misoprostol and vaginal~     misoprostol alone in induction of second trimestr miscarriage.~   "
6655|NCT03479736|"~     The purpose of this study is to evaluate whether there is an increased risk of achilles~     tendon rupture (ATR), retinal detachment (RD) or aortic aneurysm and dissection (AAD)~     following exposure to fluoroquinolone (FQ) or other antibiotics (amoxicillin, azithromycin,~     trimethoprim and trimethroprim/sulfamethoxazole) or febrile illness not treated with~     antibiotics, using a study design that minimizes the impact of confounders not usually~     captured in health services databases such as heredity or smoking.~   "
6656|NCT03479723|"~     The purpose of this study is to perform pooled analysis with data collected from 5 previously~     published studies and 8 unpublished datasets collected from international sites. The main~     goal of this study is to identify the predictors of plaque erosion.~   "
6709|NCT03479021|"~     The purpose of this protocol is to determine if the Welch-Allyn Spot Vision Screener (SPOT)~     is effective at detecting various risk factors for poor vision in developmentally delayed~     children. These children have a higher percentage of vision disorders than the average~     population. The SPOT screen itself takes about six seconds to complete. It produces a~     photograph of the eye and a print out with amount of hyperopia, myopia, astigmatism and pupil~     size. The subject will have three SPOT screens around the time of their standard of care eye~     exam. The data obtained from the three SPOT screens will be compared among themselves for~     accuracy and to the findings of the clinical eye exam.~   "
6645|NCT03479866|"~     The foods we eat - our diet - can affect whether we develop diseases during our lives, such~     as diabetes or heart disease. This is because the amount and types of foods we eat can affect~     our weight, and because different foods are metabolised (processed) by the body in different~     ways.~      Scientists have also found that the bacteria in our guts (the gut microbiome) affects our~     metabolism, weight and health and that, together with a person's diet and metabolism, could~     be used to predict appetite and how meals affect levels of sugar (glucose) and fats (lipids)~     found in blood after eating. If blood sugar and fat are too high too often, there's a greater~     chance of developing diseases such as diabetes.~      The gut microbiome is different in different people. Only 10-20% of the types of bacteria~     found in our guts are found in everyone. This might mean that the best diet to prevent~     disease needs matching to a person's gut microbiome and it might be possible to find~     personalised foods or diets that will help reduce the chance of developing chronic disease as~     well as metabolic syndrome.~      The study investigators are recruiting volunteers aged 18-65 years to take part in a study~     that aims to answer the questions above. The participants will need to come in for a clinical~     visit where they will give blood, stool, saliva and urine samples. The participants will also~     be given a standardised breakfast and a glucose monitor (Abbott Freestyle Libre-CE marked) to~     monitor their blood sugar levels. After the visit, the participants will be asked to eat~     standardised meals at home for breakfast for a further 10 days. Participants will also be~     required to prick their fingers at regular intervals to collect small amounts of blood, and~     to record constantly their appetite, food, physical activity and sleep using apps and~     wearable devices.~   "
6646|NCT03479853|"~     The aim of this study is to describe the clinical, meibographic and interferometric~     manifestations of phlyctenular keratitis in children.~   "
6647|NCT03479840|"~     The SYNTAX-score has been proposed as a tool for risk stratification and guiding~     revascularization therapy in patients with complex coronary artery disease.~      There are limited data on the prognostic value of the SYNTAX-score among elderly patients.~      Aim of this study was to investigate whether age modifies the impact of the SYNTAX-score on~     all-cause mortality at 2 years after percutaneous coronary intervention (PCI).~   "
6648|NCT03479827|"~     The goal of the study is to quantify wavefront aberration profiles of the eye with and~     without contact lens across the visual field. This will enable us to investigate the impact~     of the aberration on retinal image quality.~   "
6649|NCT03479814|"~     Aim of the study is to evaluate achievement of complete pathologic response (pCR) in~     high-risk rectal cancer treated with neoadjuvant concomitant chemotherapy plus~     adaptive-intensity modulated imaging-guided radiotherapy~   "
6650|NCT03479801|"~     Purpose: Total endoscopic thyroidectomy including oral approach and breast approach has~     excellent cosmetic and several functional results. Many patients, especially women,~     undergoing thyroid surgery are concerned about the postoperative cosmetic appearance of the~     neck. The procedure of total endoscopic thyroidectomy by breast approach only left three~     incisions, while by oral approach did not leave any incisions in the body surface, which is~     scarless in the neck, involved with a higher cosmetic result. However, the long-term property~     evaluation of total endoscopic thyroidectomy was not confirmed. The purpose of our study was~     to evaluate the surgical results of total endoscopic thyroidectomy (transoral approach and~     breast approach) versus conventional open thyroidectomy.~   "
6651|NCT03479788|"~     The primary objective of the Sleep and Stent II is to determine the prevalence of REM-OSA in~     DM versus non-DM patients undergoing clinically indicated PCI.~      The secondary objectives are to investigate the association between REM-AHI and (1) cardiac~     arrhythmia based on ambulatory ECG monitoring, (2) excessive daytime sleepiness, and (3)~     glycemic control in patients with DM. In addition, we will determine the prevalence of~     REM-OSA based on alternative definitions, including (a) overall AHI at least 5 with AHI~     REM/AHI NREM ratio at least 2; (b) overall AHI at least 5 with AHI REM/AHI NREM ratio at~     least 2 and with AHI NREM less than 15; (c) overall AHI at least 5, AHI REM/AHI NREM ratio at~     least 2 and with AHI NREM less than 8.~   "
6652|NCT03479775|"~     The aims of the project are to 1) evaluate different aspects of muscle function and its role~     as a potential risk and/or protective factor for traumatic knee injury in youth female~     athletes; 2) develop and evaluate a battery of muscle function tests, easily used and~     requiring minimal equipment, to be applied as an on-the-field screening tool to detect muscle~     function deficiencies and monitoring youth female athletes at high risk of traumatic knee~     injury.~      A prospective cohort design will be used, including approximately 100 female athletes (age~     15-19) from Swedish senior sports high schools who are involved in high risk sports (soccer,~     handball, floorball and basket). A test battery for muscle function has been developed~     consisting of 11 tests that previously have been used for the assessment of muscle function.~     The tests will be instructed and supervised by educated test leaders. Measurements will take~     place at the athletes' school and carried out during the first semester (autumn 2017 and~     2018). Data on injury surveillance and exposure (hours of match and training participation)~     will be collected prospectively over two years using a web-designed registration form. All~     athletes will on a weekly basis report their hours of training, minutes of match play and all~     time-loss injuries occurring during sport activity. Details on injury mechanism and diagnosis~     will be collected by each school's medical staff. The present study will contribute new~     knowledge on the role of muscle function and develop and evaluate a battery of muscle~     function tests to be used as an on-the-field screening tool for monitoring youth female~     athletes at high risk of traumatic knee injury.~   "
6653|NCT03479762|"~     This study is conducted in Europe. The aim of this study is to investigate usage of~     liraglutide for weight management in clinical practice using the CPRD (Clinical Practice~     Research Datalink) primary care database.~   "
6654|NCT03479749|"~     This study evaluates the efficacy of intra-articular administration of RegenoGel-OSP™ and~     RegenoGel™ to treat knee pain and effect on subject's activity and quality of life. During~     the study the subjects will receive two treatments at a 3-month interval. The study is~     double-blinded. The subjects will be randomized and sequentially assigned to RegenoGel-OSP™,~     RegenoGel or placebo treatment in the first treatment. In the second treatment after interval~     of three months all the subjects will necessarily receive one of the two active products. The~     follow-up period will continue for one year after first treatment.~   "
6657|NCT03479710|"~     Multidrug-resistant organisms (MDRO) present an increasingly serious public health threat to~     the global community.The prevalence of various MDRO, including carbapenem-resistant~     Enterobacteriaceae (CRE) and vancomycin-resistant Enterococcus (VRE), has been increasing~     worldwide, and some have become endemic in certain countries. Data from the Hospital~     Authority showed that the number of carbapenemase- producing Enterobacteriaceae (CPE) cases~     increased from 36 in 2012 to 134 in 2015. A large outbreak of VRE involving >200 patients was~     recently reported in a tertiary hospital in Hong Kong.~      The primary site of colonization and persistence of most MDRO is in the gastrointestinal~     tract. Carriage can persist for months, with up to 40% of individuals still having~     colonization one year after hospital discharge. Outbreaks of MDRO have been reported in~     hospitals and long-term care facilities. Around 10% of patients colonized with MDRO would~     develop clinical infections by the same organism. Infections caused by these MDRO carry~     significant morbidity and high mortality of up to 50%, however, there is no proven therapy~     for eradication of intestinal colonization of MDRO.~      There is accumulating evidence showing that the gut microbiota plays an important role in the~     control of intestinal colonization and infection by pathogenic bacteria. Administration of~     obligate anaerobic commensal bacteria to mice has been shown to markedly reduce VRE~     colonization. Preliminary evidence, mainly from anecdotal reports, have shown that fecal~     microbiota transplantation (FMT) in human carriers of MDRO were safe and potentially~     effective in eliminating intestinal colonization by various MDRO, including CRE and VRE, even~     in immunocompromised patients. Therefore, investigators hypothesize that FMT will be safe and~     potentially effective in eradicating intestinal colonization of CRE and VRE.~      This is a prospective pilot study to evaluate whether FMT is safe and effective to eradicate~     intestinal colonization of CRE and VRE.~   "
6658|NCT03479697|"~     The purpose of this study is to determine that effects of an intervention called~     High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM), on Stage~     1 Primary Hypertension (systolic BP 130-139, and/or diastolic BP 80-89).~   "
6659|NCT03479684|"~     To compare the efficiency and safety between gene-oriented group and standard care group~     during 90 days of initial warfarin-treatment for requiring anticoagulation patients with~     valve replacement or atrial fibrillation with or without valvular heart disease。~   "
6660|NCT03479671|"~     The primary goal of this study is to determine the dose of fatty acids that acutely induces~     mild insulin resistance in healthy volunteers. We hypothesize that a low-dose of fatty acid~     infusion (Intralipid/heparin) will cause a mild insulin resistance. The dose of fatty acid~     infusion that reliably causes mild insulin resistance will be selected for use in future~     studies.~   "
6661|NCT03479658|"~     An adequate physical activity level has important effects on cardiovascular health of~     children. However, the scientific literature suggests that few children meet the physical~     activity recommendations to obtain these cardiovascular benefits which may have immediate and~     long term consequences in public health. High intensity interval training (HIIT) has emerged~     as an effective strategy for improving physical and mental health in children. To note that~     HIIT can be completed in a shorter period of time and its results in physical health seem to~     be equivalent to those obtained in longer sessions of traditional aerobic training. However,~     there is no information about the dose of HIIT needed to obtain significant effects on~     cardiovascular health of children.~      The adoption of healthy dietary habits is also important in the prevention of obesity and~     cardiovascular diseases.~      School-based programs including physical activity and nutritional education have been~     recommended as important components of programs aiming to prevent obesity and cardiovascular~     diseases.~   "
6662|NCT03479645|"~     This pilot study is a 2-armed randomized controlled trial assessing the impact of a~     multimodal approach on colorectal cancer screening participation rates in a Federally~     Qualified Health Center. The trial will test serial text message reminders and opt-out mailed~     fecal immunochemistry test (FIT) home kits against a simple reminder text message control.~     Patients aged 50-74 years, who are registered at a Family Practice and Counselling Network~     (FPCN) clinic and are overdue for colorectal cancer screening will be recruited. The primary~     outcome is the rate of FIT kits being returned at 12 weeks.~   "
6663|NCT03479632|"~     By doing this study, researchers hope to learn the effects of aerobic exercise on heart,~     lung, and bone health in people who cannot walk after a stroke.~   "
6664|NCT03479619|"~     A randomized single-blind study with the use of three lancing devices equipped with personal~     lancets. Every device will be studied for three lancet sizes: 28G, 30G, and 33G with the~     minimum and maximum puncture depth setting.~   "
6665|NCT03479606|"~     This study will examine the efficacy of an emotion regulation intervention delivered online~     to individuals with Traumatic Brain Injury (TBI) with deficits in emotion regulation. 104~     subjects will be enrolled and will receive 24, 60-minute emotion regulation skills-training~     sessions twice a week for 12 weeks, delivered online in a group video-conference with 3-4~     other participants. Participants will be asked to complete an online survey, lasting~     approximately 40-50 minutes, every four weeks during the intervention and 12-week follow-up~     phase. Attendance and compliance will be tracked, and outcomes will be monitored using online~     data collection methods.~   "
6666|NCT03479593|"~     Acute myocardial infarction owes to a plaque rupture resulting in total (STEMI) or partial~     occlusion (NSTEMI) of the coronary artery. In patients with a partial occlusion and multi~     vessel disease (MVD), identification of the lesion responsible for the current event~     (culprit) at the time of the examination (coronary angiogram, CAG) can be difficult.~      Meanwhile, identification of the culprit lesion is vital to conduct proper treatment.~     Furthermore, treating an artery with no plaque rupture (non-culprit), imposes a small risk~     for complications, which may be fatal. Precise identification of the culprit lesion in NSTEMI~     patients with MVD remains unsettled~      The purpose of this study is proper and precise identification of the culprit lesion in~     NSTEMI patients with MVD.~   "
6667|NCT03479580|"~     Long-term prognostic value of macrovascular and microvascular coronary artery stenoses in~     each type of cardiomyopathy.~   "
6668|NCT03479567|"~     The purpose of this study was (1) to investigate changes in gait, balance, fine motor~     function, and muscle tone, and (2) to find out if there is a correlation between muscle~     tone/presence of paratonia and motor function (gross and fine) in mild and moderate~     dementia.Three groups of participants were included in the study: healthy elderly (n=60),~     participants with mild dementia (n=31) and participants with moderate dementia (n=31).~     Measurements of fine motor function, balance, gait, presence of paratonia and muscle tone~     measurements were performed.~   "
6710|NCT03479008|"~     Objective: Test the ability of vibration to produce physiologic, biochemical, and anatomic~     changes consistent with exercise that would help prevent the development of muscle weakness~     that occurs when patients are immobile for long periods of time.~   "
10203|NCT03433248|"~     The current study aims to explore the clinical effects and mechanistics of mono- and~     combination therapy with SGLT-2 inhibitor empagliflozin and DPP-4 inhibitor linagliptin on~     renal physiology and biomarkers in metformin-treated T2DM patients.~   "
6669|NCT03479554|"~     The investigators propose to conduct a multicenter randomized trial to test the primary~     hypothesis of whether early antihypertensive treatment starting between the first 24-48 hours~     after the onset of an acute ischemic stroke will reduce the risk of composite case-fatality~     and major disability (modified Rankin Scale score ≥3) at three months compared to delayed~     antihypertensive treatment (starting on day 8 after stroke onset). In the proposed China~     Antihypertensive Trial in Acute Ischemic Stroke II (CATIS-2), the investigators will recruit~     4,776 patients from 100 hospitals within the China-US Collaborative Stroke Clinical Trial~     Network. Eligibility criteria for the trial participants include age ≥40 years, acute~     ischemic stroke confirmed by CT/MRI, symptom onset between 24-48 hours, and average systolic~     blood pressure (BP) between 140-200 mmHg at randomization. Patients with extracranial or~     intracranial artery stenosis (≥70%) in both sides or the affected side, NIH Stroke Scale~     score of ≥21, Glasgow Coma Scale score <8, preceding moderate or severe dependency (modified~     Rankin scale score 3-5), revascularization, intravenous thrombolytic therapy or mechanical~     thrombectomy will be excluded. All eligible patients will discontinue their home~     antihypertensive medications. Patients admitted within 24 hours of symptom onset will require~     a reevaluation prior to randomization at 24 hours after stroke onset. After randomization,~     patients in the early treatment group will immediately receive antihypertensive treatment~     aimed at lowering average systolic BP by 10-20% within the first 24 hours and achieving an~     average BP <140/90 mmHg within five days. Patients in the delayed treatment group will~     discontinue antihypertensive medications for the first seven days. After seven days, both~     groups will receive antihypertensive treatment with a BP goal of <140/90 mmHg. The primary~     study endpoint is a composite outcome of death and major disability at three months. The~     major secondary endpoint will be the first recurrent stroke (hemorrhagic or ischemic) over~     three-month follow-up after randomization. Other secondary endpoints include ordered 7-level~     categorical score of the modified Rankin Scale, all-cause mortality, major vascular events,~     cognitive impairment, and health-related quality of life at three months. The proposed study~     provides 85% statistical power to detect a 15% reduction in the composite outcome of death~     and major disability over three months at a significance level of 0.05 for a two-sided test.~     Based on experience from our previous trials, we assumed a 25% event rate of the primary~     study endpoint and potential loss to follow-up of 5% over three months. The CATIS-2 trial~     will provide important information for the development of clinical guidelines in the early~     management of BP among patients with acute ischemic stroke for reducing mortality and major~     disability.~   "
6670|NCT03479541|"~     Every year 1.7 million people sustain a traumatic brain injury (TBI) in the United States and~     of these, 84 % are considered mild TBI (mTBI). mTBI is common both in civilian and military~     populations and can be debilitating if symptoms do not resolve after injury. Balance problems~     are one of the most common complaints after sustaining a mTBI and often prevent individuals~     from returning to their previous quality of life. However, the investigators currently lack~     clear guidelines on when to initiate physical therapy rehabilitation and it is unclear if~     early physical therapy is beneficial. The investigators believe that the underlying problem~     of imbalance results from damage to parts of the brain responsible for interpreting sensory~     information for balance control. The investigators hypothesize that retraining the brain~     early, as opposed to months after injury, to correctly interpret sensory information will~     improve recovery. The investigators also believe this retraining is limited when~     rehabilitation exercises are performed incorrectly, and that performance feedback from~     wearable sensors, can improve balance rehabilitation. There are three objectives of this~     study: 1) to determine how the timing of rehabilitation affects outcomes after mTBI; 2) to~     determine if home monitoring of balance exercises using wearable sensors improves outcomes;~     and 3) to develop a novel feedback system using wearable sensors to provide the physical~     therapist information, in real-time during training, about quality of head and trunk~     movements during prescribed exercises. The findings from this research could be very readily~     adopted into military protocols for post-mTBI care and have the potential to produce better~     balance rehabilitation and quality of life for mTBI patients and their families.~   "
6671|NCT03479528|"~     Functional dyspepsia is one of the most common gastrointestinal disorders (FGIDs) encountered~     in clinical practice.Clinical diagnosis is notoriously unreliable in diagnosing the~     underlying cause of dyspepsia,but a number of alarm features have been suggested as~     indicating patients at higher risk for serious disease. The predictive value of alarm~     symptoms still require more researches. Rome IV introduced more precisely define the minimal~     thresholds for frequency and severity of each individual symptom, primarily for scientific~     purposes,but data still need to be collected to define thresholds based on the frequency~     and/or severity of symptoms that impair quality of life.A cross-sectional study was conducted~     to assess the predictive value of alarm symptoms in patients with dyspepsia based on Roman~     IV.Through endoscopy results to determine whether dyspepsia is organic or functional, benign~     or malignant, through contacts with the basic data, to determine the alarm symptoms~   "
6672|NCT03479515|"~     The overall objective of the proposal is to evaluate the ability of ultrasound to predict the~     body composition of toddlers in the outpatient clinical setting and to evaluate the~     relationship between body composition and neurodevelopment.~   "
6673|NCT03479502|"~     We will recruit a total of 40 patients from the Vanderbilt Sports Medicine Clinics who have~     been diagnosed with adhesive capsulitis and have not undergone any previous treatment. The 40~     patients will be randomized, with 20 in the control group of 3 intra-articular injections of~     40mg Methylprednisolone spaced every two weeks, and 20 in the experimental group of 3~     intra-articular injection of 50mg doxycycline spaced every two weeks. Both groups will begin~     a standardized physical therapy program within a pain-free range of motion 4 weeks after the~     initiation of treatment. We will prospectively follow patients for one year, with follow-up~     at 6 weeks, 12 weeks, 6 months, and 12 months after the initiation of treatment.~      Outcomes will be measured using the American Shoulder and Elbow Score (ASES) and objective~     measurements of shoulder range of motion, which will be collected by the treating physician.~     Both the patients and physicians participating in the study will be blinded.~   "
6674|NCT03479489|"~     The purpose of this study is to determine the safety and effectiveness of human dehydrated~     amnion chorion allograft in closed hemorrhoidectomy as assessed by patient and wound~     assessments.~   "
6675|NCT03479476|"~     This study is a controlled trial of metformin in individuals with fragile X syndrome between~     the ages of 6 and 25 years. Participants will be randomized in a double-blind design to~     either drug or placebo and will attend three visits to the study site in a 4-month period for~     a series of tests. The primary objectives are to assess safety, tolerability, and efficacy of~     metformin in the treatment of language deficits, behavior problems, and obesity/excessive~     appetite in individuals with fragile X syndrome.~   "
6676|NCT03479463|"~     This trial aims to determine if intra-operative use of human dehydrated amnion chorion~     allograft improves post-operative patient healing outcomes.~   "
6711|NCT03478995|"~     Patients will be enrolled in two stages:~        -  Dose-escalation stage: Approximately 15-30 patients will be enrolled.~        -  Dose-expansion stage: 6-12 patients will be enrolled. Dose-escalation slots will be~          filled first, then dose-expansion slots.~   "
6924|NCT03476213|"~     This study compares manual total intravenous anesthesia (TIVA) and target-controll infusion~     (TCI) in reduction of awareness and dreaming, and the haemodynamical stability during~     operation. Half of patients will be anesthetized using manual TIVA and other half using TCI.~   "
6677|NCT03479450|"~     The traditional concept believes that the etiology of neonatal respiratory distress syndrome~     (RDS) is immature development of lung,especially the surfactant synthesis system,and RDS is~     still one of the major causes of mortality and morbidity in newborns, especially premature~     infants.In recent years, using pulmonary surfactant replacement therapy (PS treatment) in the~     treatment of respiratory distress syndrome (RDS) is a major breakthrough in neonatal~     medicine.Combined with clinical practice and experience,and through Meta analysis of related~     randomized controlled trials (RCTs),it confirms that natural surfactant treatment can reduce~     mortality,the incidence of pulmonary air leaks (pneumothorax and interstitial lung~     emphysema),and the incidence of bronchopulmonary dysplasia (BPD) or 28-day-old mortality.For~     RDS in preterm infants whose gestation is <35 weeks ,surfactant replacement therapy is also~     more effective than in nearly term and full term infants.Therefore, in the analysis of cases~     of different gestational age groups,the investigators should focus on the study of premature~     infants cases.Due to less relevant research for using PS treatment to cure newborn RDS in~     high altitude area,this retrospective study conducts statistics and analysis of recently~     three-year cases in some hospital of high altitude area,to explore the treatment effect of~     the high altitude region and the impact of altitude on the treatment.~   "
6678|NCT03479437|"~     A voluntary prospective study that will allow registration and follow-up of individuals with~     MC4R pathway genetic obesity.~   "
6679|NCT03479424|"~     The HOME PREDICT HF study looks at new ways to predict hospitalizations for heart failure. We~     will use a set of devices at home and surveys to collect information about patient's health.~     This study uses the Eureka app, a new study app developed by the University of California,~     San Francisco. The study is designed to happen remotely, using this application on a~     patient's smartphone, so that is as convenient as possible to participate.~   "
6680|NCT03479411|"~     Phase 1, 3-part study to assess safety, tolerability and PK of single and multiple doses of~     itraconazole administered as a dry powder for inhalation (PUR1900) in healthy subjects (parts~     1 and 2) and a 2-period crossover study of single doses of itraconazole administered as a dry~     powder for inhalation (PUR1900) and an oral solution (Sporanox) in adults with mild to~     moderate, stable asthma (part 3)~   "
6681|NCT03479398|"~     This project compares two methods of assessing the quality of cognitive behavioral therapy~     (CBT) that do not involve directly observing sessions: 1) adherence checklists embedded in~     clinical notes, and 2) rating the quality of worksheets that are completed with therapist~     guidance during sessions. It also examines whether ratings of worksheets completed on a~     mobile app are reliable and valid quality measures. This information can inform strategies to~     monitor and enhance CBT quality, which can ultimately improve the quality of care and~     clinical outcomes.~   "
6682|NCT03479385|"~     The purpose of this study is to conduct a randomized controlled trial or RCT of the following~     2 supportive care interventions in recent breast cancer survivors: an Integrative Medicine~     intervention based on Ayurvedic medicine and a Health Education intervention.~   "
6683|NCT03479372|"~     Double-masked, uncontrolled, multi-center, study in which participants will be randomized to~     one of 3 doses of topical ocular PAN 90806 administered once daily for 12 weeks.~   "
6684|NCT03479359|"~     The investigators conduct this prospective study to investigate the learning curve of digital~     rectal examination (DRE) for prostate cancer among internship. The investigators want to know~     how many DRE are usually needed for internship to be performed in urological practice to~     obtain a stable DRE accuracy.~   "
6685|NCT03479346|"~     The Purpose of this trial is to investigate the efficacy and safety of GGT on Korean obese~     Women with or without metabolic syndrome Risk factors~   "
6686|NCT03479333|"~     The prosthetic treatment with dental implants is challenging in posterior maxilla, where~     there is a sinus pneumatization. For the rehabilitation of patients with intermediate bone~     level, short implants have been used as alternative. It is also needed to look for the~     prosthetic context of rehabilitation with implants, like the use of different materials as~     abutments. The aim of this study is to compare the survival of two sizes of implants (short~     vs standard) placed in upper premolars region with need of bone graft, with a minimum of~     three years of follow-up, and assess the behavior of different abutments (titanium vs~     zirconia) in prosthesis in this context. This will be a randomized clinical trial with two~     groups: 1) standard implants and sinus lift; and 2) short implants without sinus lift. The~     patients who fulfill the inclusion criteria and accept to participate of this study, will be~     included in the randomization process. At the implant installation, a brown envelope, with~     the word SHORT or STANDARD, will be open, in order to determine the group. Abutment type will~     be also randomized. Four months after the installation, torque will be confirmed and the~     abutment will be installed. Implant failure and prosthesis failure in function of the~     abutment will be the outcomes. Data analysis will be conducted following a previously~     established spreadsheet using the Kaplan-Meier method and log rank test for success and~     survival, followed by Cox regression, if possible and according to the number of failures.~   "
6687|NCT03479320|"~     This will be a randomized double blinded clinical study conducted in patients undergoing oral~     and maxillofacial surgery under general anesthesia. Lidocaine group will receive intravenous~     bolus 1.5 mg/kg at induction followed by continuous infusion of 2 mg/kg/hr until the~     completion of surgery.Normal saline group will receive same amount of intravenous normal~     saline .The primary outcome will be postoperative pain using the NRS scale during first 24~     hours and time to first analgesic request~   "
6688|NCT03479307|"~     To evaluate the efficacy of Bilastine ophthalmic solution 0.6% compared to vehicle and~     Zaditen (Ketotifen ophthalmic solution 0.025%) for the treatment of the signs and symptoms of~     allergic conjunctivitis.~   "
6707|NCT03479047|"~     The Rapid Shallow Breathing Index (RSBI) is the ratio between respiratory rate (RR) and tidal~     volume (VT). It is routinely used to predict mechanical ventilation weaning outcome in ICU~     patients. However RSBI doesn't reflect the muscular contribution of diaphragm or accessory~     muscles in generating tidal volume. Actually, diaphragmatic dysfunction can even delay~     weaning process, because accessory muscles are more fatigable than the diaphragm.~      Hence, the investigators hypothesized that diaphragmatic displacement (DD) could be~     associated with RSBI in a new index named Rapid Shallow Diaphragmatic Index (RSDI) such as:~     RSDI = RSBI/DD.~      The aim of this study is to compare the ability of the RSDI versus the traditional RSBI to~     predict weaning success in ready-to-wean patients.~   "
6689|NCT03479294|"~     This study will establish a multi-center, prospective registration database. The included~     population are stage II and IIIA NSCLC patients undergoing R0 resection and will be scheduled~     for adjuvant chemotherapy. Before the first adjuvant chemotherapy, under the recommendation~     of a doctor, patients will voluntarily choose to use (exposed group) or not to use (control~     group) Shenlingcao Oral Liquid, which donated by Jiangzhong Group for 30 bottles. The~     research centers need to be consecutively enrolled patients according to the allocation of~     the number of cases according to the ratio of 3: 1 in exposure group and control group.~      The exposed and control groups will be followed up to 36 months (non-allelic follow-up).~     Information from patients will be prospectively collected, including baseline,~     chemoradiation, use of Shenlingcao Oral Liquid and the other complementary drugs, and various~     outcome measures (the questionnaire of EORTC QLQ, death, tumor recurrence, tumor metastasis,~     and chemotherapy-induced side effects of the blood system, etc.). Follow-up points included:~     Baseline (before giving chemotherapy), 2-3 days after each chemotherapy cycle, and~     6,12,18,24,30,36 months after enrollment.~   "
6690|NCT03479268|"~     This phase I trial studies the side effects and best dose of pevonedistat when given together~     with ibrutinib in participants with chronic lymphocytic leukemia or non-Hodgkin lymphoma that~     has come back or has stopped responding to other treatments. Pevonedistat and ibrutinib may~     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~   "
6691|NCT03479255|"~     The study aim is to evaluate the effectiveness of a coached, smartphone-enabled exercise~     program versus physician directed exercise therapy (usual care).~   "
6692|NCT03479242|"~     In this prospective pilot study, patients with DFU visiting the Ohio State University~     Comprehensive Wound Center will be enrolled. Patients enrolled in the study will be followed~     for 16 weeks for wound closure(Phase A), and will then begin Phase B~   "
6693|NCT03479229|"~     This study is evaluating the safety and efficacy of the Geneveve Treatment for women~     experiencing diminished sexual function following vaginal childbirth. Participants will be~     randomized to either active or sham treatment and followed for 12 months.~   "
6694|NCT03479216|"~     Arthroscopic meniscus surgeries are the most frequent orthopedic procedures. The objective of~     the study is to compare the effects of intraarticular local anesthetic and adjuvant~     (dexmedetomidine vs magnesium) combinations in postoperative pain and analgesic requirement.~     The investigators' hypothesis is adjuvants added to the local anesthetics decreases the total~     local anesthetic dose, provides more effective pain relief according to local anesthetic~     only, and decreases the postoperative systemic non-steroidal analgesic and opioid doses.~   "
6695|NCT03479203|"~     The purpose of this study is to examine the acute effects of nicotine free electronic~     cigarette aerosol on vascular function in healthy, non-smokers.~      This study comprises a portion of a larger study comparing results of vascular function in~     nonsmokers to vascular function in healthy smokers chronically exposed to nicotinized~     electronic cigarette aerosol versus conventional cigarettes.~   "
6696|NCT03479190|"~     Greater Trochanteric Pain Syndrome (GTPS), also known as Trochanteric Bursitis, is a painful~     condition predominantly affecting middle aged women. It is characterised by pain in the~     lateral hip exacerbated by movement and lying on the affected side. GTPS encompasses~     different conditions including gluteus medius/minimus tendinopathy and bursal inflammation.~     The treatment for this condition begins with conservative treatments of analgesia and~     physiotherapy, which normally results in a resolution of symptoms. If this fails then steroid~     injections have been shown to be effective. If this is not successful patients are offered~     surgery. Steroid injections however may only be effective in the short term and sometimes~     patients require repeat injections. Platelet rich plasma (PRP) is plasma taken from the blood~     of the patient that has been treated so that it has a higher than usual concentration of~     platelets in it. It has been postulated to promote healing in damaged or inflamed tissues.~     Platelets contain a variety of growth factors, which are involved in healing. It has been~     used in a variety of orthopaedic conditions such as lateral elbow epicondylitis, patellar~     tendonitis, rotator cuff pathology and planter fasciitis. Studies have shown varying effects~     of PRP in these conditions with most promise in plantar fasciitis and patellar tendonitis.~     These conditions are similar to GTPS. A recent review of treatments for GTPS concluded that~     more research into PRP efficacy in GTPS is required. We hypothesise that PRP is effective in~     treating GTPS in patients who have not responded to conservative management (analgesia and~     physiotherapy). This is an area that lacks research and could be valuable to those suffering~     from GTPS. Further study is required as PRP could be used as instead of steroid injections or~     if steroid treatments have failed and this could prevent patients from suffering further or~     needing surgery.~      The investigators propose a randomised control trial comparing a normal saline injection with~     a PRP injection in patients with GTPS, diagnosed by MRI scan, who have not responded to~     conservative treatments. Patients will receive either PRP or normal saline under ultrasound~     guidance by a consultant rheumatologist. Sample size calculation has shown that the~     investigators will need to recruit a total of 100 patients who will be randomised into either~     arm (50 in each arm). The recruitment period will last 2 years with the whole trial aiming to~     finish in 4 years from the proposed start date. Neither patients or the study team members~     assessing the outcomes will know which treatment the patient received. Patients will be~     followed up at 3, 6 and 12 months. The primary outcome measure will be a patient reported~     outcome measure (PROM) i-HOT12 (international hip outcome tool) which is a valid and reliable~     scoring system that assesses patient's ability to return to an active lifestyle through~     obtaining subjective measures of symptoms, as well as determining emotional and social health~     status.~      This will be alongside secondary outcome measures Visual Analogue Pain Score, Modified Harris~     Hip Score and EQ-5D collected. The proposal was discussed with a group of patients who~     previously had treatment with Platelet Rich Plasma (PRP) injection for hip pain. A discussion~     was had with regards the setup of a study and they were enthusiastic about this. A patient~     information sheet was shown to them and modified as per their comments. Their advice was~     obtained with regards the setup of this study, the randomisation into placebo arm, followup~     frequency and the outcome measures. In particular, patients suggested that if placebo was not~     working then a switch over to treatment arm should be discussed sooner than the initially~     planned one year. This has been taken into account and six month has been agreed. The~     proposal was also discussed in the NRES committee who are satisfied with the proposal.~     Ethical approval has been granted and the study is registered with Health Research Authority~     England.~   "
6697|NCT03479177|"~     The purpose of this study is to examine the effect of a home-based high intensity interval~     training intervention on exercise among low active adults (defined as engaging in exercise 90~     minutes or less per week). Participants will be randomly assigned to a HIIT-based~     intervention or a wait-list control each lasting 12 weeks (participants in the wait-list~     control condition will have the option of receiving the HIIT intervention following the 12~     weeks).~   "
6698|NCT03479164|"~     The primary objective of this research project is development and validation of a new,~     non-contrast gated aortic (NCGA) computer tomography scan algorithm for screening of aortic~     aneurysm in the chest and abdomen in at risk patients. This study would initially be~     performed in patients with a known aneurysm and done in addition to their indicated~     surveillance CT scan.~   "
6699|NCT03479151|"~     The primary objective of this study is to determine whether intra- and post-procedural MR~     changes are indicative of reduction in pain symptom scores. The trial will recruit a cohort~     of patients with painful bone metastases, who wish to consider MRgHIFU treatment. These~     patients will be identified in conjunction with the pain and palliative care teams, as well~     as clinical and medical oncologists. Patients will undergo MRgHIFU treatment using scanning~     and treatment planning methods that have been established in the patients treated within the~     multi-centre study. The treatment response rate for the cohort will be recorded. Intra- and~     post-procedural imaging metrics will be evaluated for their ability to detect tissue changes,~     which may be indicative of response. Patients will be followed-up for up to 90 days after~     treatment, and will attend for repeat imaging and pain review at days 30, 60 and 90 after~     treatment. Any changes in imaging metrics will be compared between responders and~     non-responders.~   "
6700|NCT03479138|"~     Define and characterize the neutrophilic phenotype of severe asthma.~   "
6701|NCT03479125|"~     A post-treatment follow-up observational study for liver disease subjects with or without~     liver cirrhosis after receiving emricasan or placebo.~      Subjects must have been enrolled in a prior IDN-6556 study to be eligible.~   "
6702|NCT03479112|"~     This is a randomized controlled study evaluating the ability of laypersons to correctly apply~     a tourniquet using different instructional methods. There are four arms being evaluated:~     flashcards, audio-kit with visual aids, formal in person Bleeding Control Basic (B-Con)~     course, and a control arm. All participants will then undergo B-Con training at the end of~     each session and then participants will be evaluated within a 3-6 month time period to~     evaluate their retention of knowledge and skills taught by the B-Con course.~   "
6703|NCT03479099|"~     The purpose of this study is to assess clinical utility of combined circulating tumor cell~     (CTC) and circulating tumor DNA (ctDNA) in the diagnosis of primary lung cancer.~   "
6704|NCT03479086|"~     To compare the clinical effectiveness, tolerability, and cost-effectiveness of topiramate to~     active control (naltrexone) on treatment outcomes for alcohol dependence in a double-blind~     randomised controlled trial.~   "
6705|NCT03479073|"~     To investigate the rate and risk factors of stroke or systemic embolism (SE) following atrial~     fibrillation (AF) ablation.~   "
6706|NCT03479060|"~     This study evaluates the short and long-term effects of application of Wet Cupping Therapy~     (WCT) in the treatment of migraine headaches in adults.Half of the participants will continue~     WCT application and the other half will not.~   "
6712|NCT03478982|"~     This is a multi-center, double-blind, randomized, parallel group, dose-ranging study to~     investigate the efficacy and clinical usability of STAP-001 in adult (18 years of age and~     older) subjects with epilepsy with a predictable seizure pattern. These subjects have an~     established diagnosis of focal or generalized epilepsy with a documented history of~     predictable seizure episodes. This is an in-patient study. The subjects will be admitted to a~     Clinical Research Unit (CRU) or Epilepsy Monitoring Unit (EMU) for study participation. The~     duration of the stay in the in-patient unit will be 2-8 days. One seizure event per subject~     will be treated with study medication. The duration and timing of the seizure event and~     occurrence of subsequent seizures will be assessed by the Staff Caregiver(s)1 through~     clinical observation and confirmed with video electroencephalogram (EEG).~   "
6713|NCT03478969|"~     This interventional device study aims to compare mainly standard Multiple Dose Injection~     (MDI) therapy vs. Accu-Chek® Solo Micropump System and investigates participant satisfaction.~     In addition, a third arm is included to compare to only similar product on the market which~     is OmniPod. The third arm is for data collection purpose.~   "
6714|NCT03478956|"~     This study will evaluate pharmacokinetics, pharmacodynamics and safety of etrolizumab in~     pediatric patients of 4 to <18 years of age with moderate to severe ulcerative colitis (UC)~     or with moderate to severe Crohn's disease (CD).~   "
6715|NCT03478943|"~     The investigators conduct the real world study to explore the efficacy and safety of Apatinib~     in gastric cancer .~   "
6716|NCT03478930|"~     The overall purpose of this study is to evaluate the safety, efficacy, and durability of~     response of omalizumab in an open-label setting in adult participants with chronic~     rhinosinusitis with nasal polyps who completed the double-blind, placebo-controlled, Phase~     III Study GA39688 or GA39855. Participants will be eligible for enrollment in the study at,~     or within 28 days after, the Week 24 visit of Studies GA39688/GA39855. After enrollment into~     this open-label extension (OLE) study, participants will receive 28 weeks of dosing of~     omalizumab before entering a 24-week off-treatment observation phase of the study. Baseline~     in this OLE study is defined as the last pre-treatment measurement prior to randomization in~     Studies GA39688/GA39855 (i.e., baseline of Studies GA39688/GA39855). The data that will be~     reported from baseline to Week 24 inclusive will come from Studies GA39688/GA39855.~   "
6717|NCT03478917|"~     Background:~      Painful vasoocclusive crisis (VOC) occurs in people with sickle cell disease (SCD). People~     with VOC have many visits to the hospital. About 10 30 percent of these people will go on to~     develop acute chest syndrome (ACS). ACS can cause further ill health. It can also cause~     death. Researchers want to find ways to diagnose ACS more quickly. To do this, they want to~     use stored blood samples and scans from a study (the DeNOVO trial) that was closed in 2015.~     They want to see if scans and samples taken of people with VOC who later developed ACS could~     help diagnose ACS faster. The data of people in the DeNOVO study who did not develop ACS will~     serve as controls.~      Objectives:~      To look at data from the DeNOVO trial to find a way to diagnose ACS more quickly.~      Eligibility:~      People 10 85 years old who took part in NHLBI Protocol number 05-H-0019 (the DeNOVO trial).~     The trial lasted from 2004 to 2008. The study was closed in November 2015.~      Design:~      Scans and intact, frozen samples from a study that was closed in 2015 will be studied. No new~     participants will be enrolled.~   "
6718|NCT03478904|"~     Background:~      Enzalutamide is given to treat metastatic prostate cancer. But it takes 4 pills to deliver~     the effective dose. This can be difficult for people already taking multiple drugs. And~     swallowing may be difficult for some people. Researchers want to test out a new way of giving~     enzalutamide by mouth. They want to see if giving a person the liquid taken from inside the~     standard 4 gelatin capsules is handled by the body in the same way as giving them the~     capsules whole.~      Objectives:~      To compare how capsule and liquid forms of enzalutamide are handled by people with prostate~     cancer.~      Eligibility:~      Men at least 18 years old with prostate cancer~      Design:~      Participants will be screened with a heart test (electrocardiogram), medical history, and~     physical exam. A tissue sample or lab reports will be reviewed.~      During the study, participants will repeat screening tests and have urine tests.~      Participants will be randomly assigned to get the study drug in one of two orders: either the~     as capsules then the liquid form (Arm A) or as the liquid form then the capsule form (Arm B).~      Participants will be counseled about birth control.~      The study will have 2 periods with a minimum 42 day break in between.~      On Day 1 of Period 1 and Day 1 of Period 2, participants will be admitted to the hospital.~     They will get one dose of the study drug. They cannot eat or drink anything except water for~     at least 10 hours before and for 4 hours after the study drug. Their blood will be sampled~     over 24 hours. Lunch and dinner will be served. Participants will answer questions after~     taking the liquid form.~      Participants will have blood drawn on Day 3, Day 8, and Day 42.~   "
6719|NCT03478891|"~     Background:~      Ebola is a virus that has infected and killed people mostly in West Africa. There is no~     treatment or prevention for it, but several drugs are being studied. Researchers want to test~     the drug MAb114 in healthy people not exposed to Ebola to see whether it can be used for~     Ebola treatment in people who are infected in the future. This trial will not expose~     volunteers to the Ebola virus.~      Objectives:~      To see if MAb114 is safe and how a person's body responds to it.~      Eligibility:~      Healthy adults ages 18-60 who weigh 220.5 pounds or less~      Design:~      Participants will be screened under protocol NIH 11-I-0164 with:~        -  Medical history~        -  Physical exam~        -  Blood or urines tests~      Participants will have a first 8- to10-hour visit. They will get MAb114 by IV infusion. For~     this, a thin tube will be placed in an arm vein. They may get an IV line in their other arm~     to collect blood. Blood will be taken many times before and after the infusion. Participants~     may have a urine test.~      Participants will get a thermometer to check their temperature for 3 days after they get~     MAb114. They will record their highest temperature and any symptoms.~      Participants will have about 14 more study visits over 6 months. At each visit, they will~     have blood taken and be checked for any health changes. They will talk about how they are~     feeling and if they have taken any medications.~      At the end of the 6 months, participants may be invited to take part in another study for~     follow-up sample collection.~   "
6727|NCT03478787|"~     The main objective of this study is to evaluate the efficacy and safety of risankizumab~     compared with secukinumab for the treatment of adult subjects with moderate to severe plaque~     psoriasis who are candidates for systemic therapy.~   "
6720|NCT03478878|"~     Background:~      Age-related macular degeneration (AMD) is an eye disease. It is the leading cause of vision~     loss in people over 55 in the U.S. Changes in the eye can make it difficult for they eye to~     adjust to low light. This is known as dark adaptation. This is particularly significant in~     people with reticular pseudodrusen (RPD). Identifying and watching the early to middle stages~     of AMD and changes in dark adaptation might help researchers learn to stop the disease before~     it becomes severe. Taking vitamin A might help improve vision in people with RPD.~      Objectives:~      To see if taking 16,000 IU of vitamin A per day improves vision in people with RPD. Also to~     improve understanding of RPD and associated dark adaptation.~      Eligibility:~      Adults ages 50 and older with RPD and normal liver function~      Design:~      Participants will be screened with:~      Medical and eye disease history~      Eye exam: The pupil will be dilated with eye drops. Pictures will be taken of the retina and~     the inside of the eye.~      Including the screening visit, participants will have at least 5 visits. They will be about~     once a month over 6 months and last 4 6 hours. Visits include:~      Questions about eye problems in certain light~      Eye exam~      Blood and urine tests~      Dark adaptation protocol: Participants will sit at a machine in a dark room. They will look~     into the machine and push a button when they see a light. This lasts 20 40 minutes.~      Participants will take a vitamin A supplement by mouth once a day for 2 months. They will~     record when they take the pills in a diary.~   "
6721|NCT03478865|"~     Background:~      Age-related macular degeneration (AMD) is an eye disease. It is the leading cause of vision~     loss in people over 55 in the U.S. Changes in the eye can make it difficult for the eye to~     adjust to low light. This is known as dark adaptation. Identifying and watching the early to~     middle stages of AMD and changes in dark adaptation might help researchers develop new~     treatments to stop the disease before it becomes severe. Taking vitamin A might help improve~     vision in people with AMD.~      Objectives:~      To see if taking 16,000 IU of vitamin A per day improves vision in people with AMD. Also to~     improve understanding of AMD and associated dark adaptation.~      Eligibility:~      Adults ages 50 and older with AMD and normal liver function~      Design:~      Participants will be screened with:~      Medical and eye disease history~      Eye exam: The pupil will be dilated with eye drops. Pictures will be taken of the retina and~     the inside of the eye.~      Including the screening visit, participants will have at least 5 visits. They will be about~     once a month over 6 months. Visits include:~      Questions about eye problems in certain light~      Eye exam~      Blood and urine tests~      Dark adaptation protocol: Participants will sit at a machine in a dark room. They will look~     into the machine and push a button when they see a light. This lasts 20 30 minutes.~      Participants will take a vitamin A supplement by mouth once a day for 2 months. They will~     record when they take the pills in a diary.~   "
6722|NCT03478852|"~     Background:~      Epilepsy affects about 1 percent of the U.S. population. Most people with epilepsy respond~     well to medicine, but some do not. Researchers want people who have diagnosed or suspected~     epilepsy to participate in ongoing studies. They want to learn more about clinical care for~     epilepsy. They want fellows and residents to learn more about the care of people with~     epilepsy.~      Objectives:~      To learn more about seizures and find ways to best treat people with drug-resistant epilepsy.~      Eligibility:~      Adults and children ages 8 years and older with diagnosed or suspected epilepsy~      Design:~      Participants will be screened with:~      Physical exam~      Medical history~      Questionnaires~      Participants will have many visits. They may be admitted to the hospital for several weeks.~     Their medication might be stopped or changed.~      Participants will have many tests:~      Blood and urine tests~      EEG: Wires attached to the head with paste record brain waves. This may be videotaped.~      Thinking and memory tests~      MRI: Participants lie on a table that slides in and out of a tube. They perform simple tasks~     in the tube.~      MEG: Participants lie on a table and place their head in a helmet to record brain waves.~      PET scan: Participants lie on a table that slides into a machine. A small amount of~     radioactive dye is injected into their arm with an IV. For the IV, a small tube is inserted~     into the arm with a needle.~      Participants will stay enrolled in this study if they join other epilepsy-related studies.~     They may be contacted at intervals for follow-up. Their participation will end if they have~     not been seen clinically for their epilepsy for 3 years.~   "
6723|NCT03478839|"~     Background:~      Generalized Arterial Calcification of Infancy (GACI) is a very rare disorder. It can be fatal~     before birth or by age 6 months. Anumber of people with GACI survive into adulthood. Those~     adults suffer from side effects of the disease, including rickets. It is unknown how common~     the disease Autosomal Recessive Hypophosphatemic Rickets Type 2 (ARHR2) is. It also has side~     effects. GACI and ARHR2 are usually caused by the mutations in the same gene. There are no~     approved treatments for the two diseases. Researchers want to study people with these~     diseases and their family members. This may help understand these rare and unique diseases~     better. The data could lead to new treatments for GACI and ARHR2.~      Objectives:~      To better understand the progression of GACI and ARHR2 and how genes might play a role in~     them.~      Eligibility:~      People with GACI or ARHR2, both living and deceased, and their parents and siblings.~      Design:~      Participants will allow researchers to access their medical records. They will give this~     consent by mail, email, or fax.~      Data will be taken from the records. Participants names will not be used. Instead, they will~     be identified by a code.~      Participants may give a blood sample.~      If a participant withdraws from the study, their data and samples will be destroyed. However,~     the coded clinical data in the official medical record and data in databases will NOT be~     destroyed.~   "
6724|NCT03478826|"~     To develop a repository of blood, urine and tissue samples from patients with ILD to support~     future studies into the development of such biomarkers.~   "
6725|NCT03478813|"~     The Voiding School is a simple educational intervention to treat children with daytime~     incontinence or enuresis.The purpose of this study is to implement the intervention in~     primary care, child welfare clinics. Half of the participated children will receive treatment~     according the Voiding School protocoll and half of them will receive treatment as usual.~     Patient outcomes are evaluated by measuring changes in wetting episodes. Aim is also to~     evaluate the implementation process.~   "
6726|NCT03478800|"~     Is it feasible to perform acupuncture in the training field after sport performance in~     adolescent football players?~      Does acupuncture provide a decrease in muscle soreness and improvement in overall sense of~     well-being in the adolescent football population?~   "
6728|NCT03478774|"~     This study compares under controlled conditions if different flow rates affect apnoea time~     after induction of anaesthesia and how CO2 clearance is influenced. Furthermore, this study~     enables to quantify the effects of increased pCO2 on vital parameters (e.g. blood pressure,~     cardiac output, cerebral perfusion, etc.) The investigators will enroll patients undergoing~     elective surgery at the University Hospital of Bern, Switzerland.~      Once anesthesia has been induced, apnoea will set it. During this period, the investigators~     will compare different methods of apnoeic oxygenation for a maximum of 15 minutes.~      Before discharge, an interview will be conducted, assessing complications and patient~     satisfaction.~   "
6729|NCT03478761|"~     You are being asked to take part in this research registry because you or your family member~     is suspected to have a 24-hydroxylase deficiency.~   "
6730|NCT03478748|"~     This study aimed to compare the impact of anticipatory guidance on the caries incidence of~     2-3-year-old preschool children and their 4-6-year-old siblings, as well as on their mothers'~     oral health literacy, as compared to the conventional Ministry of Health (MOH) programme.~   "
6731|NCT03478735|"~     This study will compare the analgesic benefit of a traditional landmark-guided GON block with~     the ultrasound-guided approach over a four week period in patients with occipital neuralgia~     or cervicogenic headache.~   "
6732|NCT03478722|"~     The most severe form of chronic renal failure is end-stage-renal-disease with maintenance~     hemodialysis (MHD) as the most common treatment strategy. MHD patients experience a number of~     metabolic and phenotypic derangements including skeletal muscle wasting. Previously, it has~     been demonstrated that dialysis treatment leads to increased rates of forearm phenylalanine~     uptake (proxy for 'muscle' protein synthesis) with an even greater rates of phenylalanine~     release (proxy for 'muscle' protein breakdown). Hence, the dialysis procedure itself is~     catabolic and induces a catabolic carryover for several hours after dialysis. This suggests~     prolonged post-dialysis disturbances in whole body- and skeletal muscle protein metabolism in~     MHD patients. Moreover, dialysis treatment in itself results in ~20 % losses of circulating~     amino acids in the dialysate. Collectively, this creates the need for replacement of amino~     acids by protein supplementation during and/or after dialysis. The ingestion of protein-dense~     meals in between dialysis treatments likely represents an important dietary strategy to~     counterbalance dialysis-induced catabolism and to achieve the current recommended protein~     intakes (set at 1.2 g/kg bodyweight/d) to limit muscle protein loss in MHD patients. However,~     the effectiveness of protein-rich meal ingestion to augment postprandial whole body and~     muscle protein metabolic responses in MHD patients outside of the dialysis period remain~     largely undefined.~      The purpose of this study is to compare basal and postprandial whole body leucine body~     kinetics, muscle anabolic sensing mechanisms, markers of muscle proteolysis, and myofibillar~     protein synthesis rates to mixed meal ingestion on a non-dialysis day in eight MHD patients,~     between 20-80 and to compare these outcomes to age- and BMI-matched controls. The~     investigators will use specifically produced intrinsically L-[5,5,5-2H3]leucine labeled eggs~     combined with primed constant amino acid tracer infusion methods and concomitant blood and~     muscle direct sampling to make direct assessments of in vivo protein digestion and absorption~     kinetics and subsequent postprandial muscle protein synthetic responses in MHD patents and~     controls. On the test day, subjects will remain sedentary for the determination of muscle~     protein synthesis in both the fasted state and after consumption of the meal.~   "
6733|NCT03478709|"~     The measurement of dynamic arterial elastance (Eadyn) was proposed as a marker of vascular~     tone. It is calculated by the ratio of the respiratory variation of the pulse pressure and~     the respiratory variation of stroke volume. Despite several clinical studies, no study has~     really focused on the physiological significance of Eadyn. No study demonstrates at present,~     if this index is a reflect of macrocirculatory parameters (systemic resistances, blood~     pressure, arterial elastance, ventricular elastance, ventriculo-arterial coupling) or~     microcirculatory tone in the capillaries and small arterioles (critical capillary pressure or~     capillary resistance). the physicians don't know which variables are associated with this~     index. the hypothesis is that Eadyn is an indirect reflect of capillary pressure (PCC).~   "
6734|NCT03478696|"~     The primary purpose of this study is to evaluate lung function and health related quality of~     life (HRQoL) after 84 days of treatment with a single inhaler triple therapy combination of~     FF/UMEC /VI [100/62.5/25 microgram (mcg)] once daily via ELLIPTA® compared with a multiple~     inhaler combination therapy of Symbicort Metered Dose Inhaler (MDI) (budesonide/formoterol~     320/9 mcg) twice daily plus Spiriva HandiHaler (tiotropium 18 mcg) once daily. The study will~     inform healthcare providers that subjects can be effectively and safely switched to FF/UMEC~     /VI single inhaler therapy from a multiple inhaler triple therapy regimen of Symbicort MDI~     and Spiriva Handihaler. Eligible subjects will enter a 4-week run-in period during which they~     will be administered budesonide/formoterol (320/9 mcg) twice daily plus tiotropium (18 mcg)~     once daily plus placebo via ELLIPTA. Following the run-in period, subjects will be randomized~     to receive one of the following study treatments for 84 days: 1) FF/UMEC /VI 100/62.5/25 mcg~     via ELLIPTA once daily in the morning plus two inhalations of placebo to match~     budesonide/formoterol via MDI, twice daily plus placebo to match tiotropium via HandiHaler~     once daily in the morning or 2) Budesonide/formoterol 320/9 mcg via MDI, twice daily plus~     tiotropium 18 mcg via HandiHaler once daily in the morning plus placebo via ELLIPTA once~     daily in the morning. Subjects will then enter a one week follow-up period. The total~     duration for a subject in the study will be approximately 17 weeks. ELLIPTA is a registered~     trademark of the GlaxoSmithKline group of companies.~   "
6735|NCT03478683|"~     The primary purpose of this study is to evaluate lung function and health related quality of~     life (HRQoL) after 84 days of treatment with a single inhaler triple therapy combination of~     FF/UMEC/VI [100/62.5/25 microgram (mcg)] once daily via the ELLIPTA™ compared with a multiple~     inhaler combination therapy of Symbicort Metered Dose Inhaler (MDI) (budesonide/formoterol~     320/9 mcg) twice daily plus Spiriva HandiHaler (tiotropium 18 mcg) once daily. The study will~     inform healthcare providers that subjects can be effectively and safely switched to~     FF/UMEC/VI single inhaler therapy from a multiple inhaler triple therapy regimen of Symbicort~     MDI and Spiriva Handihaler. Eligible subjects will enter a 4-week run-in period during which~     they will be administered budesonide/formoterol (320/9 mcg) twice daily plus tiotropium (18~     mcg) once daily plus placebo via ELLIPTA. Following the run-in period, subjects will be~     randomized to receive one of the following study treatments for 84 days: 1) FF/UMEC/VI~     100/62.5/25 mcg via ELLIPTA once daily in the morning plus two inhalations of placebo to~     match budesonide/formoterol via MDI, twice daily plus placebo to match tiotropium via~     HandiHaler once daily in the morning or 2) Budesonide/formoterol 320/9 mcg via MDI, twice~     daily plus tiotropium 18 mcg via HandiHaler once daily in the morning plus placebo via~     ELLIPTA once daily in the morning. Subjects will then enter a one week follow-up period. The~     total duration for a subject in the study will be approximately 17 weeks. ELLIPTA is a~     registered trademark of the GlaxoSmithKline group of companies.~   "
6759|NCT03478371|"~     This study will evaluate the impact on vaginal health of four different tampons using~     gynecologic assessment and subjective assessment of comfort during in-use conditions~   "
6736|NCT03478670|"~     Adenosine deaminase (ADA) enzyme deficiency results in severe combined immunodeficiency~     (SCID), a fatal autosomal recessive inherited immune disorder. Strimvelis (or GSK2696273) is~     a gene therapy intended for patients with ADA-SCID and for whom no suitable human leukocyte~     antigen (HLA) matched related stem cell donor is available. This therapy aims to restore ADA~     function in hematopoietic cell lineages, and in doing so prevents the pathology caused by~     purine metabolites (i.e., impaired immune function). This registry will evaluate the long~     term safety and effectiveness outcomes of subjects who have received Strimvelis (or~     GSK2696273).~   "
6737|NCT03478657|"~     Asthma is a chronic inflammatory disease of airways and lungs that results in~     hyper-reactivity and clinically relevant episodes of wheezing. This study has been designed~     to assess the correct use and ease of use of the ELLIPTA® DPI in pediatric subjects with~     asthma. ELLIPTA DPI is easy to use, requires few steps, is consistent in dosing and~     eliminates the hand-breath co-ordination required for metered dose inhalers (MDIs). Subjects~     will be stratified by age into two strata: Stratum 1: subjects in the age group of 5 to 7~     years and Stratum 2: Subjects in the age group of 8 to 11 years. All subjects will be trained~     by Health care professionals (HCP) for the correct use of ELLIPTA DPI. Subjects will be given~     three chances to attempt correct use of ELLIPTA DPI; subsequently, if the subject is not~     successful, the parent/guardian will be able to help instruct the subject on the correct use~     of the ELLIPTA DPI. The subjects who will be enrolled in the study will take placebo ELLIPTA~     DPI once daily. After 28 days subjects will be randomized in 1:1 to receive a questionnaire~     (Version A and B). After completion of the questionnaire on ELLIPTA DPI ease of use,~     subject's ability to use ELLIPTA DPI correctly will be re-assessed. Approximately 219~     subjects will be screened to participate in the study. The study will be conducted for 28~     days. ELLIPTA is a registered trademark of GlaxoSmithKline (GSK) group of companies.~   "
6738|NCT03478644|"~     The purpose of this two-phase study was to evaluate the oral and dermal tolerance of an~     experimental, non-rinse denture cleansing wipe after 7 and 14 days of use. In addition, the~     consumer acceptability of the denture cleansing wipes was also evaluated via a consumer~     acceptability questionnaire. A methodology was also evaluated to assess the efficacy of the~     denture wipe at removing food debris as exploratory objective.~   "
6739|NCT03478631|"~     The project aims to determine the effect of a high-nitrate dietary intervention on blood~     pressure and markers of vascular function compared to a low-nitrate intervention in people~     with elevated blood pressure. Half of the participants will receive the high-nitrate~     dehydrated vegetable intervention, while the other half will receive the low-nitrate~     dehydrated vegetable intervention.This project will advance the current hypothesis on the~     therapeutic link between dietary nitrate and high blood pressure, and potentially derive~     impactful recommendations for individuals at risk of hypertension.~   "
6740|NCT03478618|"~     To compare the effect of two different protocol of fluid therapy in sever preeclamptic~     patients under spinal anesthesia : Hemodynamic and kidney function .~   "
6741|NCT03478605|"~     Olanzapine-containing regimens for CINV prophylaxis may provide even better protection than~     aprepitant-containing regimens.~   "
6742|NCT03478592|"~     The meta-analysis comparing the cryopreservation of human embryos by vitrification or~     slow-freezing suggested that more well design studies as randomized trials are necessary to~     identify the most successful method for cryopreservation. The efficacy of the vitrification~     with the GAVI system will be compared with the conventional slow freezing method through a~     randomized control trial. Couples in IVF attempt will be randomized at the day of embryo~     cryopreservation by the biologist. Supernumerary frozen embryos will be thawed and~     transferred in utero in case of failure of the fresh embryo transfer. The outcomes of the~     thawing and frozen/thawed embryo transfer will be assessed. In the two groups, the patients~     will benefit of the standard IVF procedures applied in the Assisted Reproductive Technologies~     (ART) center of Toulouse.~   "
6743|NCT03478579|"~     The investigators will study nontechnical skills of emergency physicians in a virtual~     standardized emergency room and their impact on quality of care.~   "
6744|NCT03478566|"~     There is an unmet demand for the evaluation of nocturnal hypoventilation in children with~     NMD. An ambulatory screening tool that can reliably facilitate timely diagnosis and treatment~     in these children would be invaluable. If an ambulatory, at home, tcCO2 monitoring device is~     shown to be diagnostically accurate, sleep physicians would be able to triage children on~     existing waiting lists and optimize screening of nocturnal hypoventilation as recommended by~     international guidelines.~   "
6745|NCT03478553|"~     This study seeks to screen first degree family members of people with Idiopathic Pulmonary~     Fibrosis (IPF) for the earliest signs of lung fibrosis.~   "
6746|NCT03478540|"~     To explore whether gut microbiota would impact CD4 T cells recovery in HIV-infected patients~     on antiretroviral therapy (ART). We prospectively enroll patients initiate ART and collect~     their fecal at followup for one year.~   "
6747|NCT03478527|"~     Theory and research on the gut-brain-axis emphasizes complex interactions between the gut~     microbiota, immunological and hormonal responses, brain function, brain structure, as well as~     resulting behavioral manifestations, such as cognitive functions and mental illness.~     Probiotics are living micro-organisms that change the composition of the gut microbiota and~     have a positive effect on the host's general health and well-being. Probiotic bacteria~     naturally occur in foods such as Sauerkraut, olives, and dark chocolate, and are currently~     also added to industrial products.~      Regarding the effect of probiotics on brain structure and function, animal studies have shown~     that the administration of probiotics in mice and rats was linked to neurogenesis in the~     hippocampus and and improvement of associated cognitive functions. The majority of these~     studies applied probiotics for 4 weeks. The substances used in these studies were often~     composed of several bacterial strains, suggesting that the neurogenic effect may not be~     reducible to a specific type of probiotic bacteria. In addition, probiotics seem to be~     effective in improving memory abilities, including spatial and non-spatial memory both in~     rodents and humans. Regarding mental illness, in comparison to animal studies for beneficial~     effect of probiotics on anxiety, depression and stress, the evidence in humans is compelling,~     but methodologically sound (randomized-controlled trial [RCT], double blind) studies are~     still lacking.~      To sum up, the present study is going to be the first RCT with human participants that~     investigates structural and functional changes of the hippocampus through probiotic bacteria,~     using Magnet Resonance Imaging (MRI). In addition, the study aims at advancing research in~     the field by investigating probiotic effects on a broader spectrum of cognitive functions,~     particularly those associated with hippocampal activity (e.g. spatial memory, verbal memory).~     In addition, effects on several types of mental illness (e.g. anxiety, depression, stress)~     will be studied. Furthermore potential mechanisms that may promote the aforementioned effects~     will be examined by investigating changes in immunological parameters, the 'brain derived~     neurotrophic factor' (BDNF), and oxytocin.~   "
10416|NCT03430466|"~     The aim of this study is to evaluate the safety and efficacy of anti PD-L1 antibody + anti~     CTLA-4 antibody in combination with hormone therapy in patients with hormone receptor~     positive HER2-negative recurrent or metastatic breast cancer.~   "
6748|NCT03478514|"~     The proposed study is a single-arm, multi-center, open-label phase II study of the~     combination of palbociclib and ibrutinib in patients with previously treated mantle cell~     lymphoma to evaluate the efficacy of this combination, with the primary objective of the~     study being to assess median PFS and the secondary objectives to include ORR, CR, DOR, OS and~     toxicity. Subjects will be enrolled and treated with palbociclib and ibrutinib with each~     cycle of therapy being 28 days. Treatment will be based on the recommended phase II dose~     (RP2D) from the phase I combination trial.~   "
6749|NCT03478501|"~     Limiting access to a firearms during suicidal crisis can save lives. This study will test a~     patient decision aid about safe firearm storage during crisis. The investigators will enroll~     60 adult emergency department patients being evaluated for suicidal risk and have at least~     one firearm at home. If available, the investigators will also enroll a family member or~     friend. Participants will randomly receive one of two things: the decision aid or general~     suicide prevention information. A week later, the investigators will call participants to see~     how both groups choose to store their firearms. This trial tests the acceptability of the~     decision aid, effects on decision making, effect on home storage, effect on suicide outcomes,~     and feasibility of a larger trial. The investigators hypothesize that patients with higher~     quality decisions after the decision aid will be more likely to change their firearm storage~     to reduce access during the time of crisis; should the pilot demonstrate feasibility, in a~     subsequent larger trial this hypothesis would be tested directly.~   "
6750|NCT03478488|"~     This is a randomized, open-label, parallel-group multi-center study of Phase 3 study to~     assess the efficacy and safety of KN035 compared to standard of care (SOC) Gemcitabine-based~     chemotherapies in the treatment of participants with previously untreated locally advanced or~     metastatic biliary tract cancer.~      The primary hypothesis of this study is that participants will have a longer overall Survival~     (OS) when treated with combined therapy than SOC.~   "
6751|NCT03478475|"~     Age affect insulin sensitivity and the metabolism, and vitamin D status was shown to have a~     correlation with markers of insulin resistance. That's why, we aimed in our trial to study~     the effect of vitamin D supplementation on glycemic markers and index of insulin resistance.~   "
6752|NCT03478462|"~     The study evaluates CLR 131 in children and adolescents with relapsed or refractory malignant~     solid tumors and lymphoma and recurrent or refractory malignant brain tumors for which there~     are no standard treatment options with curative potential.~   "
6753|NCT03478449|"~     The aim of this study is intending to provide the optimal procedures of lymph node sorting~     for pathological examination after curative surgery for gastric cancer, which can~     discriminate the differences of the status of lymph node metastasis, pTNM classification and~     prognostic outcome of gastric cancer patients.~   "
6754|NCT03478436|"~     This study explored the impact of food on skin and plasma pharmacokinetics of doxycycline~   "
6755|NCT03478423|"~     Background: Emergency department (ED) providers are frequently challenged with how best to~     treat acute pain in older patients, specifically when non-opioid analgesics are insufficient~     or contraindicated. Studies have documented older patients presenting to the ED with painful~     conditions are less likely to receive pain medications than younger patients, and this~     inadequate pain control has been associated with increased risk of delirium and longer~     hospital stays. Given the concerns for drug interactions, adverse side effects, over-sedation~     and addiction; emergency physicians often report uncertainty regarding the ideal choice of~     opioid analgesic in older adults. There are no guidelines informing best practice for the~     management of acute pain in this population.~      Objective: The primary objective is to compare the efficacy of codeine, oxycodone and~     hydromorphone for acute fracture pain in older patients discharged from the ED.~      Methods: This will be a blinded, randomized controlled trial of older adults (age ≥ 70)~     discharged home from the ED with acute pain secondary to an upper extremity, lower extremity,~     rib, pelvic or vertebral compression fracture. Patients will be randomized to receive a 3-day~     supply of codeine, oxycodone or hydromorphone. Patients will also be given acetaminophen.~     Patients will be contacted by phone or email 3 days following their ED visit. The primary~     outcome will be differences in pain scores at 3 days assessed using the validated Brief Pain~     Inventory (Short Form). Secondary outcomes will include side effects (ie: confusion,~     constipation), adverse events (i.e, falls, healthcare visits) and pain interference with~     daily activity. Patients, physicians and all research staff will be blinded to group~     allocation.~      Importance: All analgesics (including opioids) prescribed to older adults are associated with~     an increased risk of adverse events. This study seeks to inform ED providers of opioid~     efficacy, side effects and patient-important, functional outcomes in this growing patient~     population.~   "
6756|NCT03478410|"~     Exosome plays an important role in the pathophysiology of the cardiovascular system. Since~     the field of cardiovascular exosome is still in its infancy, there are no available data~     regarding to its role in cardiac arrhythmias. The current study investigates the role of~     epicardial fat derived exosomes in patients who suffer from atrial fibrillation.~   "
6757|NCT03478397|"~     Cervical cancer is a serious public health problem reflecting social and gender inequalities~     in health. It is the third cause of cancer death among women in the world, with more than 85%~     of cases occurring in developing countries. Currently, new technologies based on HPV DNA~     detection allow HPV self-collection, increasing screening coverage. In a self-collection~     based strategy, triage becomes a key step in the prevention process, as it is the first~     method to identify HPV+ women who will need diagnostic and treatment procedures. However,~     high adherence to triage is difficult to obtain, which is not surprising given that adherence~     to follow-up and treatment is a generalized problem in cervical cancer programs.~      Specific aims of the study are: 1. To evaluate the effectiveness of an innovative~     multi-component mHealth intervention to increase adherence to triage among women with HPV+~     self-collected tests compared to usual care. 2. To evaluate the implementation strategy and~     identify barriers and facilitators to implementation of the multi-component mHealth~     intervention.~      The research study design will follow the structure of an effectiveness-implementation hybrid~     type I trial, and will use mix-method approach. A cluster randomized trial including 200~     Community Health Workers (CHWs) (clusters) and 4000 women will be used to evaluate the~     effectiveness of the multi-component mHealth intervention to increase adherence to cytology~     triage at 120 days after positive HPV testing. The mHealth intervention will include SMS~     messages sent to HPV+ women to inform them when results are available, and subsequent SMS~     messages as reminders. In addition, for those HPV+ women who did not have a triage cytology~     result within 60 days of the HPV test result, CHWs will receive an e-mail and SMS message so~     they can visit these women for in-person specific counseling and support. For the~     implementation evaluation, the Consolidated Framework for Implementation Research (CFIR) will~     be used to guide qualitative data collection and analysis of factors that influence~     implementation. RE-AIM will be used to assess the Reach, Effectiveness, Adoption,~     Implementation and Maintenance of the Intervention.~      Results of this project will provide evidence on the effectiveness of the multi-component~     mHealth intervention to increase triage of HPV+ women, but it could be adapted to increase~     compliance of diagnoses/treatment of other types of cancer and health problems. Findings from~     the implementation evaluation will be applicable to programs that use or are planning to~     incorporate HPV self-collection in different settings and countries. In addition, the use of~     CFIR and RE-AIM in this innovative study will serve as a model of work, constituting an~     important advance in the use of Implementation Science in the Region.~   "
6758|NCT03478384|"~     This is an open, prospective, multi-center, interventional study to evaluate the benefit and~     efficacy of individualized self-efficacy coaching for women with high-risk early breast~     cancer.~      In total, 6 sites will be assigned 1:1 to either the experimental arm (Group A) or the~     control arm (Group B). The controlled site assignment will assure a balanced site-specific~     QoL between both groups at baseline. All patients will be medically treated according to~     guidelines. The experimental Group A will in addition receive regular self-efficacy coaching.~   "
6760|NCT03478358|"~     This is an open-label, non-controlled, non-randomized study to investigate the long-lasting~     radiolabeled somatostatin analogue based peptide receptor radionuclide therapy and evaluate~     response to 177Lu-DOTAEB-TATE in patients with advanced metastatic neuroendocrine tumors.~     Different groups with doses of 0.37GBq-0.74GBq (10-20 mCi) and 1.85GBq (50 mCi)of~     177Lu-DOTA-EB-TATE,3.7GBq (100 mCi)of 177Lu-DOTA-TATE will be injected intravenously. All~     patients will undergo 68Ga-DOTATATE PET/CT scans before and after the treatment.~   "
6761|NCT03478345|"~     There have been some preliminary studies, primarily in animals, that suggest that exposure to~     some of the chemicals in our everyday environment, such as the chemicals found in plastics,~     may cause weight gain. It is not clear whether this also happens in humans, or whether~     decreasing exposure to these chemicals can improve success with weight loss when people adopt~     healthy lifestyle changes.~      The THRIVE Study is a 4-week group healthy lifestyle education program that is designed to~     determine whether:~        -  changes in dietary habits and the types of personal care products used can decrease a~          person's exposure to chemicals in our environment that have been suggested to cause~          weight gain~        -  whether any measurable changes in body composition (fat tissue vs. lean tissue) can be~          seen as a result of participating in the healthy lifestyle program.~   "
6762|NCT03478332|"~     Compared with conventional treatment of the coronary heart disease,the aim of the research is~     to find out if the addition of Yangxinshi pills on the basis of conventional treatment can~     improve exercise tolerance of patients with coronary heart disease, improve quality of life~     or restore social function and mental health~   "
6763|NCT03478319|"~     The purpose of the study is to assess safety, tolerance, pharmacokinetic, and~     pharmacodynamics of single and multiple doses of ACE-2494 in healthy postmenopausal women.~   "
6764|NCT03478306|"~     This study evaluates the effect of melatonin 4 mg on circadian rhythm and visual function of~     patients with diabetes mellitus. Half of the patients will receive melatonin (arm-1) and the~     other half will receive placebo (arm-2), both groups in 3 weeks. After a week of washout, the~     patients will cross over to the other treatment arm.~   "
6765|NCT03478293|"~     The purpose of this study is to evaluate the intraocular pressure (IOP) lowering effect of~     iStent inject in eyes of subjects with primary open-angle glaucoma previously on two~     anti-glaucoma medications.~   "
6766|NCT03478280|"~     A randomised, double-blind, placebo-controlled, trial to evaluate the efficacy of brodalumab~     monotherapy on vascular and systemic inflammation by 18F-FDG-PET/CT in subjects with~     moderate-to-severe plaque-type psoriasis who are candidates for systemic therapy~   "
6767|NCT03478267|"~     Pregnant women between 32-41 weeks` gestation designated for either vaginal birth or cesarean~     section will be recruited for the study. Data regarding maternal resting heart rate and fetal~     baseline heart rate as depicted on the monitor will be collected. A blood sample will be~     acquired from the parturient and the umbilical cord as well as a sample from the placenta~     will be obtained. Levels of Acetyl Choline Esterase (AChE) will be determined from all~     aforementioned samples. Statistical correlation between fetal baseline heart rate and fetal~     and maternal AChE levels will be assessed.~   "
6768|NCT03478254|"~     Observational study about adherence to guidelines for Influenza, Pneumococcal and Hepatitis B~     Vaccination in adult patients with type 1 Diabetes mellitus.~   "
6769|NCT03478241|"~     In this study the effect of different engine-driven nickel titanium (Ni-Ti) instrumentation~     systems (OneShape, Revo S and WaveOne) on postoperative dental pain in patients with~     asymptomatic teeth after a single-appointment root canal retreatment was evaluated.~   "
6770|NCT03478228|"~     The aim of the study is to investigate whether individuals with fall-related wrist fractures~     have impaired posterior control, reduced proprioception in their lower limbs and/or~     vestibular asymmetry compared with those who have not fallen and sustained a fracture.~     Secondly to investigate the effects of a new balance training method, directed at the sensory~     systems and training of fall-preventive movements on postural control and how it impacts the~     function of the sensory systems. Postural instability falls and fractures form one of the~     major problems associated with ageing. An association of vestibular- asymmetry with falls and~     fractures has been found and reduced vibration sensation in the lower limbs has been~     connected with imbalance. Wrist fractures are often precursor to the more serious hip~     fractures, which often result in decreased quality of life, even death and are costly for the~     society. Subjects will be individuals 50-75 years of age having sustained a fall-related~     wrist fracture. Measurements of sensory functions, postural control and functional ability~     will be conducted before and after balance training. Confidence in daily activities and~     self-perceived dizziness handicap will be obtained with questionnaires. The same evaluations~     will be performed on age and gender matched individuals without previous history of~     fall-related wrist fractures. This research might reveal the presence and frequency of~     vestibular asymmetry or/and other age related degenerative changes in the sensory systems,~     which decrease stability and increase the risk of falls and fractures. It could show~     preventive effects of specific balance training on fall risk, and thus increase quality of~     life of the individuals, improve healthcare services and decrease costs associated with falls~     and fractures.~   "
6771|NCT03478215|"~     Kidney transplantation is a good treatment option for people with kidney disease. However,~     there is still much to learn about how to best care for the transplanted kidney and keep it~     functioning for a long time. Transplant recipients receive induction therapy and~     immunosuppression (anti-rejection) drugs to prevent their body from rejecting the new kidney.~     These drugs are used to prevent the immune system from attacking the transplanted kidney.~     This research study will evaluate the safety and activity of mesenchymal stromal cells~     reducing the immune suppression necessary to achieve optimal renal function in renal~     transplant recipients.~   "
6772|NCT03478202|"~     The objective of this open-label pilot study is to evaluate the effect of the commercially~     available GOLO for Life (GFL) weight management program on body weight in a type 2 diabetic~     patient population after approximately 3 months.~   "
6791|NCT03477955|"~     A retrospective study that aims to report Adjacent Segment Degeneration (ASD) incidence and~     spinopelvic balance in short lumbosacral instrumentation for degenerative lumbar spinal~     stenosis. Although ASD is a common complication following lumbar fusion, the effect of an~     Interspinous Spacer (IS) in the supradjacent segment in short lumbosacral instrumented fusion~     and its interaction with spinopelvic balance has not been studied adequately.~   "
6773|NCT03478189|"~     The acetabulum fracture result from a trauma with high energy at the young adult or from a~     trauma of low energy at the old osteoporotic patient. Anatomic reduction is known to be~     necessary to give functional result to patient.However, it's technically difficult because of~     the pelvic bone conformation.~      The presence of dome impaction makes the surgery more difficult. Per operatory scanner~     associated to 3D navigation is proved his value-added in spinal surgery.The aim of the study~     is show that this association permit a technical improvement for the surgeon in the precision~     of fracture reduction.and restore the articular congruence.~   "
6774|NCT03478176|"~     Intraabdominal hypertension (IAH) is a frequent and severe condition affecting intensive care~     patients. Gold standard for estimation of intraabdominal pressure is intravesical pressure~     (IVP) measurement. IVP measurement is recommended in patients presenting IAH risk factor(s).~     Acute kidney injury is the most frequent and described complication of IAH condition.~      Patients undergoing kidney transplantation have several risk factors to develop IAH.~     Nevertheless, to our knowledge, IAH incidence, associated factors and impact on renal~     function recovery remains unknown.~      We aim to study IAH incidence, associated factors and impact on renal function recovery in~     post kidney transplantation period.~   "
6775|NCT03478163|"~     The goal of this study is to identify whether antibiotics given at the time of placement of~     an intrauterine balloon tamponade (IBT) will result in reduction of the risk of endometritis.~     The investigators hypothesize that antibiotics given at the time of intrauterine balloon~     tamponade will reduce the likelihood of postpartum endometritis.~   "
6776|NCT03478150|"~     this is a randomized controlled clinical trial, evaluating the antibacterial effect of laser~     diode and zinc oxide nano-particles when used as cavity disinfectants.Two groups, including~     15 patients each, will be randomly allocated so that each group receives one of either~     interventions (15 patients will undergo cavity disinfection by laser diode, while the other~     15 patients will undergo cavity disinfection by zinc oxide nano-particles). For each patient,~     a dentin sample will be taken before and after cavity disinfection. The dentin samples will~     be microbiologically analyzed to assess the difference in the bacterial count (out come~     assessment). The results will be statistically analyzed.~   "
6777|NCT03478137|"~     Obstructive sleep apnea (OSA) is a breathing disorder that is characterized by episodes of~     complete or partial cessation of respiration during sleep, associated with upper airway~     collapse, oxygen desaturation and sleep fragmentation. OSA is a condition frequently~     implicated in cognitive disturbances, as well as associated with health conditions such as~     hypertension, metabolic disturbances and heightened risk of heart disease, stroke and~     mortality. These conditions are also increased in persons living with HIV. Individuals~     suffering from OSA report an increase in daytime sleepiness, mood changes and decline in~     quality of life.OSA also portends economic and societal impact through lost productivity at~     work and motor vehicle accidents. The presence of OSA is therefore important to detect in~     those living with HIV as it is potentially treatable contributors to cognitive disturbances~     in HIV. Continuous Positive Airway Pressure (CPAP) is the recommended treatment of choice for~     OSA. CPAP has established efficacy in improving cognition (executive function, long-term~     verbal and visual memory, attention/vigilance and global cognitive functioning). Although~     CPAP has been associated with improvements in cognitive functioning in the general~     population, its effectiveness in improving cognition in HIV+ individuals has never been~     previously tested. Given that cognitive disturbances in this population are multi-factorial,~     determining whether treatment of OSA in this population improves cognition is key in~     improving the clinical management of HIV+ individuals, both for its negative impact on~     cognition, but also more generally for their health.~   "
6778|NCT03478124|"~     The aim of this study is to better understand the nature of the cognitive decline in~     Progressive Supranuclear Palsy, the time of its development and the relation with the other~     cardinal features of the disease.~   "
6779|NCT03478111|"~     CMAB008 is an infliximab biosimilar candidate. The host cell of Remicade is mouse myeloma~     SP2/0 cell, however, the host cell of CMAB008 is CHO (Chinese hamster ovary cell). It seems~     that CMAB008 has lower immunogenicity and higher safety, because Remicade comprises more~     complex-type and hybrid-type glycans than CMAB008. However, it is not yet known whether~     CMAB008 is not inferior to Remicade. This randomized, double-blind trial investigates the~     efficacy and safety of CMAB008 for moderately to severely active rheumatoid arthritis,~     compared to Remicade.~   "
6780|NCT03478098|"~     The study will evaluate postprandial glucose excursions and gut hormone secretion after~     ingestion of meals with different glycaemic index (GI) values (high vs low) followed by an~     acute bout of exercise or rest in gastric bypass operated subjects and matched control~     subjects.~   "
6781|NCT03478085|"~     Background: Patients suffering with atherosclerotic peripheral arterial disease (PAD) have~     limited therapeutic options to improve claudication. Supervised exercise programs are~     generally effective in improving leg pain from walking, but are poorly adhered to because of~     patient discomfort. The benefit of exercise training programs is thought to be mediated in~     part through repeated ischemic stimuli that activate endogenous regenerative mechanisms. In~     preliminary studies, exercise-induced tissue desaturation by near infrared spectroscopy~     (NIRS) precedes the onset of leg pain. This proposal aims to explore a novel strategy of~     exercise training in PAD based on measured tissue hypoxia rather than pain symptoms using~     NIRS to non-invasively characterize muscle oxygen tension.~      Methods: In subjects with symptomatic peripheral arterial disease, the efficacy of a novel~     NIRS-based strategy of thrice-weekly exercise training will be assessed. Enrolled subjects~     will be randomized to NIRS-based training, traditional claudication-based training, or~     self-directed walking. The hypotheses tested include: 1) NIRS-directed exercise improves~     claudication to a similar degree as symptom-directed exercise training and 2) is superior to~     self-directed walking. In the symptom-based group, physical effort will be dictated by~     claudication symptoms, whereas in the hypoxia-based training program, physical effort is~     dictated by NIRS measure of calf oxygen tension. Efficacy in the training programs will be~     evaluated by total walking time on a standard graded treadmill test after 12 weeks. Other~     measures will be claudication onset time, subjective and objective measures of physical~     activity, changes in vascular function. In addition, the hypothesis that hypoxia-directed~     training will result in increased ischemic signaling and increased progenitor cell~     mobilization to a degree similar as in claudication-based training will be tested.~      Conclusions: These experiments will test whether a training strategy based on tissue hypoxia~     (measured by NIRS) is as effective as and more tolerable than traditional symptom-based~     training programs in PAD. In addition, these experiments will characterize mechanistic~     responses to hypoxia that may account for clinical improvements that exercise training~     affords.~   "
6808|NCT03477734|"~     A Prospective, Open, Single-Center, Controlled Study to Evaluate the Safety, Performance and~     Efficacy of the CardiacSense1 for Detection of Atrial Fibrillation.~      The clinical study is intended to establish the efficacy and safety of the CardiacSense1~     wearable device intended to monitor and detect heart arrhythmia, specifically atrial~     fibrillation (A-Fib) based on a comparison to a control device, which is an off-the-shelf~     cleared Holter ECG device~   "
38806|NCT03058744|"~     Suppression Potential of Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects~     with Moderate to Severe Plaque Psoriasis.~   "
6782|NCT03478072|"~     Autoimmune bullous diseases are a variety of skin diseases that are characterized by the~     presence of bullae or blisters. Most of these diseases are associated with substantial~     morbidity and mortality. They are classified according to the site of blister formation into~     intraepidermal as pemphigus valgaris and foliaceus, and subepidermal as bullous pemphigoid~     and dermatitis herpetiformis. These lesions commonly affect the scalp and manifest as~     blisters, erosions and crustations.~      Trichoscopy (hair and scalp dermoscopy) is a non-invasive technique in which either a~     handheld dermoscope or a digital videodermoscope can be used to visualize hair and scalp~     structures. The method has well-established position as an ancillary tool in the diagnosis of~     many disorders such as, tinea capitis, alopecia areata, androgenetic alopecia, discoid lupus~     erythematosus, lichen planopilaris, folliculitis decalvans and other hair and scalp diseases.~     Few studies have reported that immunobullous diseases present characteristic trichoscopic~     patterns. So, Trichoscopy can be used as a rapid in-office preliminary diagnostic tool in the~     differential diagnosis of these diseases.~   "
6783|NCT03478059|"~     This research aims to develop an intervention that combines mTBI-specific motor and cognitive~     challenges into a progressive and challenging rehabilitation program. We plan to develop and~     refine a combined motor and cognitive intervention using healthy athletic young adults (n=12)~     and people with a positive history of non-resolving mTBI (n=12). We will conduct limited~     feasibility testing by conducting 6 week training sessions with each subject group. We also~     plan to identify best measures for determining readiness for duty or full function by~     incorporating and testing 3 dual-task assessment measures using state-of-the-art wearable~     sensors to quantify movement.~   "
6784|NCT03478046|"~     Fetuin-A has been identified as a novel physiological regulator of insulin action in vitro,~     in intact cells and in vivo in animals. Previous research has shown that circulating levels~     of fetuin-A were increased in animal models of insulin resistance and diabetes. Additionally,~     several human investigation studies demonstrate a correlation of fetuin-A levels with body~     mass index, insulin resistance, and a fatty liver. Recently, the investigators have~     elucidated the role of fetuin-A phosphorylation in the regulation of insulin action,~     demonstrating that phosphorylation is critical for the inhibitory activity of fetuin-A. The~     objectives of this study are twofold: (1) Quantitate phosphorylated fetuin-A levels in~     individuals with insulin resistance and metabolic syndrome, and (2) Investigate the effects~     of lifestyle modifications (acute or chronic exercise and dietary modifications) on fetuin-A~     phosphorylation and insulin sensitivity.~   "
6785|NCT03478033|"~     To compared the efficacy and safety of rifampicin and rifabutin which included in the~     standard treatment of anti-tuberculosis in HIV/AIDs patients combined with pulmonary~     tuberculosis, a multi-center, prospective cohort will be established. Antiviral efficacy and~     drug drug interaction will be investigated in order to provide optimized treatment for~     HIV/AIDs with tuberculosis.~   "
6786|NCT03478020|"~     This is an open-label, fixed sequence, 4 cycle, drug-drug interaction (DDI) study of AQX-1125~     in healthy female subjects on combination oral contraceptives (COC).~   "
6787|NCT03478007|"~     The purpose of the study is to develop, design and implement an easy-to-use, cloud-enabled~     software for patients with low back pain and evaluate the effect of the system on compliance~     and quality of life. We hypothesize that a device which measures compliance to physical~     therapy regimens in patients with low back pain will increase patient participation.~   "
6788|NCT03477994|"~     This prospective, randomised, double blinded, controlled clinical trial will be conducted in~     147 patients between 60 yr and 70 yr , ASA physical status II and III, undergoing CABG.~     Patients will be randomly allocated to either dexmedetomidine or clonidine (control) groups~     .Upon arrival to ICU, in the dexmedetomidine group, patients will receive an infusion of~     0.5-0.7 μg/kg/h then 1.4 μg/kg/h if Richmond assessment sedation score from +1 to +4~      Taking into consideration if the heart rate less than 60 per minute or persistent hypotension~     reduce infusion rate by 0.2 μg/kg/h.~      Once the patient will be extubated, wean the infusion by 0.1μg/kg/h till reaching 0.2μg/kg/h.~     Slow the weaning rate if evidence of withdrawal reactions as agitation or hypertension occur.~     In clonidine group, the patients will receive 0.5μg/kg then 0.1-0.2 μg/kg/h.Primary end point~     of the study is the incidence of delirium.The secondary endpoints will be the the duration of~     extubation, the length of ICU stay, need for inotropic support or vasopressors, hospital stay~     , mean arterial blood pressure and heart rate , hospital mortality rate , all additional~     sedatives including overall doses of morphine and haloperidol the incidence of adverse events~     as bradycardia~   "
6789|NCT03477981|"~     Obesity is a wide reaching problem in the United Kingdom. The most widely used obesity~     therapies are based around drugs that reduce dietary fat digestion, and thereby reduce uptake~     of calories from the diet. While such therapies have proved effective, patient compliance is~     low due to the unwanted gastrointestinal side effects of these drugs. Dietary fibre is~     generally classified as dietary material of plant origin that is indigestible to humans.~     Dietary fibre is in fact a wide range of different compounds that have varied effects on the~     human body. Initial findings from this laboratory suggest that some types of fibre can~     greatly reduce the rate that fat is digested and absorbed in the gut.~      Whether such fibre-based test foods are acceptable (i.e. taste good, are easy to include in~     the diet and do not cause any unwanted gastrointestinal side effects) will be assessed in~     longer term studies. To carry these studies out, healthy adults will be recruited.~     Participants will attend an induction visit and will be asked to keep a food diary, and fill~     out daily questionnaires on general well-being and feelings of fullness over a two-week~     period whilst consuming the standard white bread given to them. Following this two-week~     period, participants will attend the study centre again. At this time, participants will be~     provided with dietary fibre-based study food (bread) to substitute into their standard diet~     over the following two weeks (further bread will be provided as and when required).~     Participants will fill out the same diaries and questionnaires as before over the first two~     week period.~   "
6790|NCT03477968|"~     The purpose of this study is to demonstrate the ability of new D-Dimer assay combined with a~     clinical pretest probability (PTP) to safely exclude pulmonary embolism (PE) or Deep Venous~     Thrombosis (DVT) in a 3 month follow-up.~   "
7105|NCT03473847|"~     The purpose of this study is to evaluate the repeatability and reproducibility of corneal,~     epithelial, and LASIK flap thickness using the Carl Zeiss Meditec Cirrus HD OCT 5000, Optovue~     RTVue OCT, CSO MS-39 OCT, and ArcScan Insight 100 very high-frequency digital ultrasound~     arc-scanner.~   "
6792|NCT03477942|"~     Many patients with osteoarthritis of the knee fail non-operative measures and elect to have~     knee arthroplasty to improve their quality of life. If successful, intra-articular~     mesenchymal stem cell (MSC) injections into the knee may offer another viable non-operative~     treatment modality. Additionally, this modality may have reparative or regenerative~     potential, which could lead to the first treatment for osteoarthritis that treats the~     underlying disease as opposed to symptomatic control.~      Additionally, there are no acceptable non-surgical treatments for focal chondral defects of~     the knee. Surgical treatments that do exist have diminished outcomes if performed on patients~     older than age 30-40 years. If successful, intra-articular MSC injections into the knee would~     represent the first non-operative treatment for focal chondral defects and also represent a~     potential option for treatment in patients over the age of 30-40 years.~      This trial will be a prospective, single-center phase I pilot study to evaluate the safety~     and tolerability of a single intra-articular injection of autologous bone marrow-derived MSCs~     in 16 subjects, 8 who have knee osteoarthritis and 8 who have a focal chondral defect in the~     knee. Patients will undergo a bone marrow harvest procedure at the Dahms Clinical Research~     Unit (DCRU) of University Hospitals Cleveland Medical Center. MSCs will be isolated and~     expanded. After approximately 2-3 weeks, patients will return for an intra-articular~     injection of 50x106 MSCs Subsequent study visits will occur on post-injection day 7 and~     months 2, 6, 12, and 24. Safety of intra-articular injection of MSCs will be evaluated at~     study visits by interval history, physical examination and assessment of any adverse events~     that are observed/reported. Additionally, efficacy will be evaluated by having patients~     complete functional outcome measures including: Visual Analog Score (VAS) for pain, Knee~     Injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee~     (IKDC) Subjective Knee Form, and Lysholm Knee Scale. These will be completed at the~     pre-treatment visit and then repeated at the 2, 6, 12, and 24-month follow-up visits. Lastly,~     T1 rho and T2 mapping on magnetic resonance imaging (MRI) will be used to assess for improved~     cartilage quality after intra-articular injection of MSCs. An MRI will be obtained at the~     pre-treatment visit. At the 12 and 24 month follow up visit, additional MRIs will be obtained~     and analyzed to compare the pre-treatment MRI to post-treatment MRIs.~   "
6793|NCT03477929|"~     Recombinant gonadotropins are currently used for ovarian stimulation in women undergoing to~     IVF for infertility. Recently new flexible protocols have been introduced: the single dose~     and multiple dose protocol. The single dose protocol is performed just using Cetrorelix by~     the administration of a single injection of Cetrorelix 3 mg subcutaneous when the lead~     follicle is ≥ 14 mm. The multiple dose protocol consider the daily administration of~     Cetrorelix 0.25 mg subcutaneous or Ganirelix 0.25 mg subcutaneous when the lead follicle is ≥~     14 mm and until the realization of hCG criteriaThere are few data from letterature about the~     comparison of the efficacy in pitituary suppression and pregnancy outcome of Ganirelix and~     Cetrorelix.~      Objective: to compare the efficacy in pituitary gonadotropin suppression and IVF outcome of~     multiple dose flexible gonadotrophin-releasing hormone (GnRH) antagonist administration~     according to follicular size using daily injection of Cetrorelix or Ganirelix.~      Interventions : patients are randomly assigned in to Cetrorelix acetate group or Ganirelix~     acetate group. Multiple dose of Cetrorelix acetate (0.25 mg) or multiple dose of Ganirelix~     acetate (0.25mg) are administered when the lead follicle is ≥ 14 mm until hCG criteria are~     met.Oocyte maturation trigger is performed by the administration of subcutaneous r-hCG (250~     μg) or of intramuscular hCG (10,000 IU). After 36 hour transvaginal oocyte retrieval is~     performed followed by ICSI and embrio transfer (72 hours later).~   "
6794|NCT03477916|"~     Obesity is increasing in western society at a rapid rate and is associated with metabolic and~     cardiovascular disease. Although genetics, improper diet, and sedentary lifestyle are known~     to be factors that can cause obesity, there is a new idea that certain gut microbes may also~     be involved. Patients who are obese tend to have different kinds of gut microbes compared~     with lean healthy individuals. Previous studies have shown that changing the gut microbes of~     obese individuals by doing a fecal transplant (FMT) using gut microbes from a lean individual~     improves insulin resistance. However, the effects were not maintained. In addition, research~     has highlighted a necessary role for dietary fiber in the maintenance of microbes required~     for human health and also that increasing dietary fiber can reduce inflammation that is~     associated with insulin resistance. This project builds on the findings that gut microbes can~     be modulated by both FMT and dietary fiber supplementation and will examine if combining~     these two treatments can increase the effectiveness of these treatments.~      The objective of this study is to use fecal microbial transplant to change the gut microbes~     of obese individuals to those seen in lean individuals and then to use fiber supplements to~     help maintain the beneficial effects. In this study, overweight individuals who have~     metabolic syndrome will receive a fecal transplant using a pill form and then consume a~     variety of fiber supplements for 6 weeks. Effects on metabolic parameters, quality of life,~     weight, and dietary intake will be followed. Microbial composition will be measured in stool~     samples.~   "
6795|NCT03477903|"~     The purpose of this study is to assess the treatment effect of intravenous TAK-954 in~     improving the average daily protein adequacy received through enteral nutrition in~     critically-ill participants developing EFI.~   "
6796|NCT03477890|"~     Angina in patients without obstructive coronary artery disease (CAD) is a clinical conundrum~     and patient management is heterogeneous. Hypothesis: Abnormal coronary function is common and~     clinically relevant in this population. Design: An observational cohort study and nested~     randomised controlled diagnostic strategy trial. Methods: 250 patients with known or~     suspected angina informed by validated questionnaires but without obstructive CAD (<70%~     stenosis) in an artery >=2.5 mm or structural heart disease, as revealed by CT coronary~     angiography (CTCA), will be invited to undergo coronary function testing (FFR, CFR, IMR;~     intra-coronary ACh) during invasive angiography. Patients will be randomised following~     angiography but before testing coronary function to disclosure of the coronary function test~     results or not. Treatment decisions by the attending cardiologist will be recorded before and~     after disclosure of results. Outcomes: Primary: The between-group difference in the~     reclassification rate of the initial diagnosis using logistic regression, adjusted for~     baseline factors associated with the likelihood of reclassification of the initial diagnosis.~     Secondary: Prevalence of microvascular or vasospastic angina; health status reflected by the~     EuroQol group 5-Dimensions (EQ-5D), Seattle Angina Questionnaire, Illness perception,~     treatment satisfaction questionnaires and functional status questionnaires; angina medication~     and adherence. Value: This research will provide new insights into the conundrum of angina in~     patients without obstructive CAD or structural heart disease.~   "
6809|NCT03477721|"~     Sarcopenia is an important component of cachexia associated with cancer, and their high~     incidence in cancer patients emphasizes the need for a better understanding of its~     mechanisms, which can result in better therapeutic interventions to reverse this situation~     and improve the prognosis. Our hypothesis is that the plasma concentration of IL-6 and~     c-terminal agrin is directly correlated with the loss of muscle mass and development of~     cachexia.~   "
6810|NCT03477708|"~     An observational study comparing outcomes of Extremely Low Birth Weight (ELBW) infants that~     were monitored with non-invasive Transcutaneous CO2 (TCCO2) monitor to infants that were not~     monitored by TCCO2 monitor.~   "
6797|NCT03477877|"~     The purpose of this study is to test whether the Indashyikirwa (Agents of Change) program~     is effective at preventing intimate partner violence (IPV) in communities in Rwanda.~      Because IPV has many causes, including factors that operate at the individual, couple, and~     community levels, the Indashyikirwa program is designed with multiple elements targeting~     multiple levels. A training program for couples covers gender, power, and relationship~     skills. Individual graduates this program who are interested and eligible go on to an~     activist training program to help support sustained change in their communities. Parallel~     activities operate at the Sector level to create and support change at the community level.~     Sector level activities include (1) training in gender and IPV prevention for local opinion~     leaders. (2) Establishment of Women's Spaces, which are drop in centers that provide~     support and referrals for women experiencing IPV as well as a wide range of community~     outreach services to educate communities about, gender, power, women's rights, and violence~     prevention.~      Because the intervention is comprised of multiple components and includes elements designed~     to be delivered at the Sector level, Sectors were chosen as the unit of randomization. 28~     sectors spread across 7 districts are participating; randomization as intervention or control~     was stratified across Districts to ensure adequate geographical spread of program delivery~     (Rwandan geographic administrative units are: Province > District > Sector > Cell > Village).~     Within each randomized sector are two separate assessments of program impact: (1) A Couple~     Cohort comprised of heterosexual couples who enrol together in the couples training program~     (some of whom continue into the activist training) compared to similarly situated couples in~     control communities who participate only in a standard, ongoing VSLA (village savings and~     loan association) program. Couples cohort members (both intervention and control) are~     surveyed at enrolment, 12 months post-baseline, and 24 months post-baseline. (2) A Community~     Survey designed to measure community diffusion of the intervention through the activities of~     the Women's Spaces, Opinion Leader Trainings, and activities of graduates of the activist~     training. The community survey comprises a repeat cross-sectional population-based household~     survey of married/cohabiting adults in intervention communities who are NOT direct~     participants in any of the formal trainings delivered by intervention implementation~     partners, conducted at baseline and 24 months only. This survey is designed to look at~     community level shifts in the occurrence of IPV, as well as changes in support for survivors~     and changes in attitudes among the general population.~   "
6798|NCT03477864|"~     This phase I trial studies the side effects of anti-PD-1 monoclonal antibody REGN2810~     (REGN2810) and/or ipilimumab when given together with stereotactic body radiation therapy~     before surgery in treating participants with prostate cancer that is growing, spreading, or~     getting worse, and has spread to other places in the body, or formed a small number of new~     tumors in one or two other parts of the body. Monoclonal antibodies, such as anti-PD-1~     monoclonal antibody REGN2810 and ipilimumab, may interfere with the ability of tumor cells to~     grow and spread. Stereotactic body radiation therapy is a specialized radiation therapy that~     sends x-rays directly to the tumor using smaller doses over several days and may cause less~     damage to normal tissue. Giving anti-PD-1 monoclonal antibody REGN2810 and ipilimumab with~     stereotactic body radiation therapy before surgery may make the tumor smaller and reduce the~     amount of normal tissue that needs to be removed.~   "
6799|NCT03477851|"~     Comparison of duration of efficient analgesia after painful surgical repair od foot fractures~     between groups treated with sciatic nerve block alone and sciatic nerve block simultaneously~     with i.m. tramadol~   "
6800|NCT03477838|"~     This is a pilot study. The purpose is to (1) provide access to continuous glucose monitoring~     (CGM) to patients (purchased through a grant) and (2) systematically record and analyze the~     results of the glucose monitoring by the clinical pharmacists at the clinic.~   "
6801|NCT03477825|"~     Few studies have assessed the effects of Triphala and Rubia Cordifolia from a skin~     biophysical perspective. Here, we aim to understand how these herbs can modulate the skin's~     barrier properties and the gut microbiome.~   "
6802|NCT03477812|"~     Full ambulatory polysomnography at home performed two nights in 30 healthy children and one~     night in 30 children with mono-symptomatic nocturnal enuresis (15 with polyuria and 15~     without polyuria). The children will be aged 7-14 years of age.~      The sleep will be evaluated on sleep quality, number of periodic limb movements per hour,~     blood pressure and pulse, beat to beat variation by electrocardiography during sleep,~     respiration during sleep, nocturnal urine production, and enuresis episodes.~   "
6803|NCT03477799|"~     The investigators conducted a double-blind randomised sham-controlled study. Upon enrollment~     into the study, participants were randomly assigned to one of two conditions: (i) active~     group: anodal stimulation over the right dlPFC (n = 10) or (ii) sham stimulation group (n =~     10). Participants and raters were blinded to the condition.~      Subsequently, the participants were administered the IGT and the Wisconsin Card Sorting Test~     by a trained neuropsychologist in a quiet laboratory. A computerized version of standard IGT~     was used. The order of the tasks performed in a single session was randomised.~      After the psychiatric and neurocognitive assessment, participants received three sessions of~     20-minute active or sham anodal tDCS (once a day, every other day).~      Wisconsin Card Sorting Test and a modified version of Iowa Gambling Test were readministered~     after the last application. The order of the tasks was randomized again. A brief~     questionnaire on study blinding was also administered. Safety was assessed through open-ended~     questions based on the tDCS adverse events questionnaire~   "
6804|NCT03477786|"~     The BP4DM study was initiated as a prospective randomized controlled trial to investigate the~     renal protection effect for tight blood pressure control for Taiwanese T2DM patients without~     previously diagnosed CV events. We set our primary outcome for the prevention of~     microalbuminuria development. The secondary outcomes include mortality, annual renal function~     declining rate, and development of cardiovascular events. The recruitment period for the RCT~     trial is from 2013 Oct to 2019 Dec. In addition, we also intend to continuously follow up all~     our recruited hypertensive diabetes patients for at least 10 years to observe their clinical~     outcomes including cardiovascular, renal, retinal outcomes and mortality.~   "
6805|NCT03477773|"~     Males from areas of social deprivation within the town of Middlesbrough (UK) were targetted~     and recruited on to a high-intensity, exergaming intervention over a 6-week period. Eligible~     participants were randomly allocated to an intervention group (weekly exergaming) or control~     group (normal habitual lifestyle). All participants completed baseline (week 0) and follow-up~     (week 7) measures of metabolic health. Participants in the intervention group were invited to~     three sessions a week of high-intensity exergaming performed against their peers on a~     developed boxing game.~   "
6806|NCT03477760|"~     During one month, from 1st to 30th November 2016, all patients admitted in one of the medical~     Dpt of our Hospital (Internal Medicine Dpt, Endocrinology, ICU) will be screened for~     multi-drug resistant bacteria carriage (after written consent). They will answer to a~     questionnaire about previous travel in a foreign country during the previous year,~     hospitalization or not during this travel.~   "
6807|NCT03477747|"~     The aim of this investigation is to analyse the potential benefits of wearing a new~     commercially available microcurrent device combined with different exercise training~     modalities on exercise outcomes, body composition, recovery including muscle damage, general~     markers of health and immune function in athletes.~   "
6811|NCT03477695|"~     A stooped posture is one of the characteristic motor symptoms of patients with Parkinson's~     disease, and has been linked to impairments in ADL and QOL. We aimed to test the efficacy,~     safety, practical utility and user-friendliness of a posture correction and vibrotactile~     trunk angle feedback device (the UpRight) in the home setting of patients with Parkinson's~     disease with a stooped posture.~   "
6812|NCT03477682|"~     This is a randomized controlled trial designed to analyze the impact of bedrest duration on~     return to functional independence at discharge following sartorius flap for coverage of~     vascular reconstruction in the groin.~   "
6813|NCT03477669|"~     The objective of this study is to determine the efficacy of a product combining the probiotic~     Lactobacillus GG and chamomile in treating infantile colic in exclusively breast fed infants.~     The study will be performed as a 4 week, placebo controlled, pilot trial with a one week run~     in period. Thirty subjects will be randomly assigned to each group for a total enrollment of~     60 infants.~   "
6814|NCT03477656|"~     Kidney transplantation is the treatment of choice for end-stage renal disease. ABO~     incompatible (ABOi) living donor kidney transplantation is one of the best ways to expand the~     donors' pool. However, breaking the ABO barrier is possible only with a preconditioning~     regimen that includes 1) an immunosuppressive strategy using a B-cell depleting agent~     (rituximab), an induction therapy with polyclonal antibodies, and a maintenance triple~     immunosuppressive therapy based on calcineurin inhibitors, and 2) a desensitization protocol~     aiming to decrease the titer of isoagglutinins. For this purpose, several techniques of~     apheresis are available. To date, two main techniques used in clinical setting are the~     Double-Filtration PlasmaPheresis (DFPP) and the Antigen-Specific Immunoadsorption (SIA). DFPP~     permits the depletion of the selective plasma fraction containing Immunoglobulins, while~     limiting the need for plasma substitution. SIA enables to remove ABO antibodies without a~     major loss in essential plasma components. To date, no randomized study comparing DFPP and~     SIA exist. SIA is less often used because of its high cost. However, in order to reduce the~     number of SIA sessions and consequently its cost, large plasma volume sessions of SIA are~     performed. ABOi is dramatically more expensive than ABO compatible kidney transplantation. A~     large part of the difference in the cost is related to the apheresis technique.~      Herein, the investigator proposes to describe the efficacy, the safety, and the cost of DFPP~     and SIA to desensitize ABO incompatible kidney transplant candidates.~   "
6815|NCT03477643|"~     Multiple myeloma (MM) is a plasma cell neoplasm representing the second most common type of~     hematologic tumor after lymphomas. The incorporation of novel agents such as bortezomib,~     lenalidomide, or thalidomide into first-line treatment as well as in relapse settings has led~     to a significant improvement in survival rates for MM patients, which have doubled in the~     last 5-7 years (1,2). However, except for a small percentage of patients (10-30%)(3) that may~     achieve a cure after first-line treatment, in the majority of cases, MM behaves as an~     incurable disease whose clinical course is characterized by repeated relapses, shorter and~     shorter periods of remission, and by becoming refractory to succesive treatments (bortezomib~     or lenalidomide). In this situation, survival is generally less than 9 months, which~     underscores the need to develop new drugs for MM patients Pomalidomide, a third-generation~     immunomodulatory drug (IMiD), has demonstrated efficacy in patients with relapsed and~     refractory MM, with an overall response rate that fluctuates between 30-60% depending on~     whether it is administered in combination with low-dose dexamethasone or in association with~     treatment with a cytostatic agent such as cyclophosphamide.~      In clinical trial CC-4047-MM-003, treatment with pomalidomide and low-dose dexamethasone in~     patients with relapsed and refractory MM or those intolerant to bortezomib or lenalidomide~     was a successful rescue treatment in 30% of patients with a median progression-free survival~     of 4 months. The association of cyclophosphamide at dose of 400mg/day on days 1, 8, and 15 of~     each cycle is able to increase the overall response rate from 39% for combination~     pomalidomide-dexamethasone to up to 65% for the triple regimen (pomalidomide,~     cyclophosphamide, dexamethasone - POMCIDEX), as well as the median PFS from 4.4 mo. to 9.2~     mo. respectively. As well, the tolerance and safety profiles of the triple combination~     pomalidomide, cyclophosphamide, and dexamethasone were acceptable.~      The association of bortezomib with pomalidomide-dexamethasone also increases the overall~     response rate (85%) and prolongs PFS (10.7 months).~      The BiRD study (lenalidomide, dexamethasone, and clarithromycin) suggests that clarithromycin~     intensifies the effect of corticosteroids, increasing their anti-myeloma effect . A study~     evaluating the combination of clarithromycin with pomalidomide and low-dose dexamethasone in~     RRMM patients showed an overall response rate of 57% and clinical benefit rate (considered~     equal or superior to minor response) of 66%.~      Since July 2014, pomalidomide (Imnovid®) in combination with dexamethasone has been approved~     for the treatment of adult patients with relapsed and refractory MM who have received at~     least two prior lines of therapy (including bortezomib and lenalidomide) and who have shown~     progressive disease to the last line of treatment.~      In Spain in January of 2015, and in the Spanish Myeloma Group (GEM) context, we implemented~     clinical practice guidelines for the treatment of RRMM patients who are candidates for~     pomalidomide treatment with a triple therapy combination pomalidomide + cyclophosphamide +~     low-dose dexamethasone (POMCIDEX) (Appendix 1). The goal of the clinical practice guidelines~     was to increase the overall response rate, quality of response, and progression-free survival~     in patients treated with POMCIDEX. In patients with suboptimal response (defined as stable~     disease in the first 3 cycles, or inferior to partial response after six cycles according to~     International Myeloma Working Group Uniform Response Criteria [7]), clarithromycin can be~     added to their treatment at a dose of 500mg/12hrs on days 1-28 of each cycle. Treatment can~     be administered until disease progression, unacceptable toxicity, or based on patient~     decision.~      Keeping in mind the time that has passed since the approval of pomalidomide for use in Spain~     and the publication of the clinical practice guidelines, we believe it is now time for a~     retrospective evaluation of the results of the therapeutic guidelines for Spanish MM patients~     and to review the viability of the recommendations contained in the guidelines with respect~     to compliance with the same, and effectiveness of the planned course of treatment. Once the~     viability of the proposed therapy regimen has been evaluated, other analyses for the purpose~     of studying the clinical results of treatment can be carried out as a separate analysis.~      The therapeutic paradigm for MM is rapidly changing due to the availability of new drugs for~     the treatment of patients with refractory or relapsed disease, making clinical decisions more~     challenging. For this reason, the availability of data obtained from real-life settings,~     outside of clinical trials, is essential in order to choose the appropriate treatment for~     each patient~   "
6816|NCT03477630|"~     This study is using Plasma Rich Platelets to improve the negative symptoms of adult patients~     with osteoarthrosis of the knee. Half of the patients receive Plasma Rich Platelets. The~     other half receives hyaluronic acid.~   "
6817|NCT03477617|"~     Serious complications occur in about 16% of major surgeries. Episode of hypotension during~     surgery may be a leading cause of these complications. Even though hypotension occurs~     frequently during surgery, choosing the correct treatment remains difficult in clinical~     practice. Physicians are often uncertain as to whether low blood pressure should be treated~     with intravenous fluid or vasoactive drugs. The first treatment of choice typically involves~     administering more intravenous fluid; however, excessive fluid administration during surgery~     has been shown to be deleterious. New minimally invasive hemodynamic monitors now offer a~     potential solution by guiding physicians with respect to the choice of appropriate~     intervention (i.e., fluid versus vasoactive drugs). The Investigators will conduct a~     single-center feasibility randomized control trial (RCT) at the Toronto General Hospital~     (Toronto, ON, Canada) of an algorithm to manage hypotension during surgery based on the~     information captured by a minimally invasive monitor. Sixty participants who are aged 40~     years or older and scheduled to undergo an abdominal, pelvic or vascular surgery will be~     randomized to have the intraoperative hypotension managed by either the new algorithm (guided~     by the monitor) or usual care. Participants will be recruited over 12 to 18 months, and~     followed for 30 days to describe differences in clinical care, hemodynamics, complications,~     and death. The feasibility of a future multicenter RCT will be assessed based on this present~     study demonstrating that (1) the algorithm can be practically implemented in a clinical~     setting where hemodynamic monitors are not typically used; (2) initial descriptive data~     suggest differences in care between groups; (3) there are no obvious major harms from the~     protocol; and (4) there is an acceptable participation rate among eligible patients. These~     data will inform any required changes to the algorithm and protocol to allow for its~     application in a future study.~   "
6818|NCT03477604|"~     This prospective feasibility study is a single arm, non-randomized multi-center study~     evaluating the safety and performance of the MicroStent peripheral vascular stent system for~     use in arterial lesions below the knee. A total of 15 subjects will be enrolled at 3 centers~     and followed for up to 3 years, with the primary safety and efficacy endpoints evaluated 30~     days post-implant.~   "
6819|NCT03477591|"~     Patient decision aids are tools that help guide individuals through a healthcare-related~     decision making process. They help users combine evidence-based information and~     recommendations by a health care provider with their personal needs, values and preferences.~     Through this project, Dr. Dobbins and her research team will explore whether the use of~     patient decision aids with high-quality and user-friendly summaries of research evidence, or~     summaries of research evidence alone, help to improve the quality of decision making by men~     facing prostate cancer screening decisions.~   "
6820|NCT03477578|"~     The study was aimed to investigate the role of cognition and asymmetric dopaminergic~     depletion in FoG.~   "
6821|NCT03477565|"~     Over the last two decades in the field of oncology, the prevention, diagnosis, treatment and~     rehabilitation have reached a remarkable development, improving healing rates and reducing~     the number of deaths from cancer. The most frequent cancer in the female population is the~     breast one, which consequences can become disabling. In recent years, surgeons need to find~     more effective and less invasive treatments. Nowadays, despite the achievements, oncological~     surgery can cause side effects that cannot allow the return to normal life. Some of these~     problems are represented by the formation of edema and seroma, which can be handled by the~     physiotherapist through the manual lymphatic drainage and the application of an elastic tape.~     The elastic tape is used a lot in clinical practice, despite it lacks supportive evidence.~      The primary aim of the study is to verify the effectiveness of Kinesio Tex Tape in reducing~     edema and seroma formation following complex reconstructive breast surgery. The secondary~     goals are the evaluation of the quality of the scar, of the perception of pain, of the degree~     of satisfaction and disability.~      It is a controlled, monocentric, national, comparative, randomized, single-blind study. The~     sample size is 60 patients who undergo complex reconstructive breast surgery. Patients are~     divided into two groups: the experimental one (receiving standard treatment and Kinesio Tex~     Tape application) and a group of control (just receiving standard treatment). To evaluate~     edema and seroma, ultrasound is used; ultrasounds will be on the 1st, 15th and 30th~     postoperative days (T0, T1 and T2); Vancouver Scar Scale is used to define the quality of the~     scar (T0 and T2); to measure the subjective perception of pain and to evaluate the degree of~     patient satisfaction, two VAS scales are administered (the VAS scale for pain is administered~     at T0, T1 and T2, while the VAS scale for satisfaction is given at T1 and T2); Finally, to~     assess the degree of disability, the DASH Questionnaire is used (T0, T1 and T2).~   "
6834|NCT03477396|"~     This phase IIA trial studies the side effects of ribociclib and aromatase inhibitor and how~     well they work in treating participants with hormone receptor positive breast cancer that has~     spread to other places in the body. Ribociclib and aromatase inhibitors may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth.~   "
6822|NCT03477552|"~     The primary goal of this randomized, controlled, open-label study is to determine the~     efficacy of AccuveinV400 (a transillumination veins device) to facilitate peripheral~     intravenous (IVP) catheter placement during a vaso-oclusive crisis. The investigators~     hypothesized that the number of attempts to a successful placement of a peripheral IV, our~     primary outcome, would be shorter with the assistance of the Accuvein V400. It is also~     expected that AccuveinV400 will reduce the time of the procedure, the rate of failure, the~     technique-related pain.~   "
6823|NCT03477539|"~     This phase II trial studies how well daratumumab works in treating transplant-eligible~     participants with multiple myeloma. Monoclonal antibodies, such as daratumumab, may interfere~     with the ability of cancer cells to grow and spread.~   "
6824|NCT03477526|"~     As the result of our last study Long Term effects of an Inpatient Pulmonary Program in~     Patients with Pulmonary Fibrosis already demonstrated the positive effects of a Pulmonary~     Rehabiliation on the mental status. In this current study the aim will be to analyse the~     personality type regarding anxiety and depression~   "
6825|NCT03477513|"~     The study is a pilot study to estimate the efficacy of personalized dose-escalation radiation~     therapy in patients with glioblastoma, as measured by estimating the median of~     progression-free survival. Toxicity, patterns of recurrence, and overall median survival will~     be measured as secondary endpoints. Adverse events will be monitored.~   "
6826|NCT03477500|"~     This study is a randomized multicentre, multinational, treatment interventional study of RRMS~     patients with breakthrough inflammatory disease activity in spite of ongoing standard~     immunomodulatory medication. The study has two treatment arms; arm A: HSCT (hematopoietic~     stem cell transplantation) and arm B: alemtuzumab, a registered immunomodulatory treatment of~     RRMS. A pre-planned 3-year follow-up extension period will be performed depending on future~     funding.~      The aim of the study is to assess the effectiveness and side effects of a new treatment~     intervention in RRMS; HSCT, and, thereby, the value of HSCT in clinical practice. Data from~     recently published patient series indicate that HSCT may have a significantly higher~     treatment effect than currently registered RRMS immunomodulatory treatments. This study will~     determine the relative role of HSCT versus alemtuzumab.~   "
6827|NCT03477487|"~     Evaluation of Safety, Tolerability, and Efficacy of XT-150, a plasmid DNA with a variant of~     human IL-10 transgene. XT-150 will be a single injection into the knee synovial capsule for~     the Treatment of Osteoarthritic Pain.~   "
6828|NCT03477474|"~     The purpose of this registry is to collect data that describes the characteristics of people~     with advanced cancer for whom the Guardant360 assay is ordered and to observe their clinical~     outcomes after receiving their results.~   "
6829|NCT03477461|"~     During brain death, many significant systemic changes take place and among these, the most~     notable is hemodynamic instability.~      In the pathogenesis of brain death, after the hypertensive phase of the catecholamine~     storm, arterial tonus and heart inotropism eventually deteriorate, leading to hypotension~     and hypoperfusion. Therefore, vasopressor agents are necessary in treatment of brain-dead~     organ donors. The most commonly used and recommended vasoactive drugs for this indication are~     dopamine, norepinephrine, and vasopressin.The Transplantation Committee of the American~     College of Cardiology recommends vasopressin as the primary vasoactive drug for treating~     hemodynamic instability and diabetes insipidus in brain-death heart donors.~      Terlipressin (TP) is a new type of synthetic long-acting vasopressin preparations, AVP~     long-acting derivatives, belongs to a kind of precursor drugs, itself is inactive, the body~     through the aminopeptidase, slow release of a reactive lysine vasopressin. On the one~     hand，terlipressin can splanchnic vascular smooth muscle contraction, reduces splanchnic blood~     flow (e.g., reduce blood flow to the mesenteric, spleen, uterus, etc), to ensure the flow of~     blood to the important viscera;On the other hand, it reduces the concentration of plasma~     renin, increases the perfusion of renal blood flow, and improves the glomerular filtration~     rate, thus improving renal function.From the pharmacological perspective, it is better than~     arginine vasopressin for the stability of hemodynamics and the perfusion of tissue.~      Whether or not it has therapeutic effect on the potential brain death donor with unstable~     hemodynamics is not studied in the literature at home and abroad.This paper discusses the~     application value of terlipressin in the management of potential brain death, and provides~     clinical evidence for the maintenance of brain death donor.~   "
6830|NCT03477448|"~     -  Warts are common viral infections on the skin and are prevalent worldwide. Warts are~          caused by the human Papilloma virus (HPV), which has more than 100 strains; some of them~          are known to be premalignant. Although warts can appear at any age, they are more common~          in children and adolescents. The prognosis of warts cannot be predicted. In some~          patients they may spontaneously disappear, whereas others show persistence and~          progression with spreading to other body sites, leading to physical and emotional~          distress to the patients.~        -  Factors that increase the risk include use of public showers, working with meat, eczema,~          and a low immune system . The virus is believed to enter the body through skin that has~          been damaged slightly . A number of types exist including: common warts, plantar warts,~          filiform warts, and genital warts . Genital warts are often sexually transmitted.~   "
6831|NCT03477435|"~     The investigators propose a Type I hybrid effectiveness/implementation study to evaluate two~     population-based approaches for increasing use of Quitlines and text messaging at two VA~     sites. Specifically, the investigators will test the default bias, examining whether an~     opt-out approach to referral is more effective than an opt-in approach. The investigators~     will randomly assign teams to either an opt-out or opt-in approach to referring smokers to~     treatment. In the opt-out approach, the default is that everyone is referred to treatment~     unless they actively choose not to be. In the opt-in approach, people are offered treatment~     but must actively choose to enroll in it.~   "
6832|NCT03477422|"~     The purpose of this study is to evaluate the effects of CSE-1034 (Ceftriaxone+ Sulbactam+~     EDTA) compared to Meropenem for treating hospitalized patients with complicated urinary tract~     infections, including acute pyelonephritis caused by β-lactamase producing gram-negative~     bacteria~   "
6833|NCT03477409|"~     In response to restrictions related to the use of DEHP as a plasticizer for PVC medical~     devices (MDs), manufacturers have resorted to alternative plasticizers. These are now~     integrated into many MDs such as infusion sets, extension lines, extracorporeal circuits,~     nutrition tubings ... etc. The ARMED project (2012-2015) funded by the ANSM, whose goal was~     to prioritizing the risk linked to the migration of these plasticizers from MDs, has shown~     that TOTM and DEHT present the best benefit / risk ratio due to lower migration and~     cytotoxicity. Nevertheless, it is important to evaluate the level of exposure of neonatal~     intensive care patients, due to the multi exposure to MD made of PVC, the frequent use of~     intravenous route and the vulnerability of this at-risk population to the metabolites of~     these plasticizers.~   "
6836|NCT03477357|"~     Subjects will be admitted to hospital the evening prior, or the morning of surgery, whereupon~     they will undergo standard admission processes, including pre-operative assessment by the~     anaesthetist assigned to that list (One of the two study authors). The anaesthetist will then~     explain the study again, reiterating the potential risks and benefits of the study to the~     patient themselves, and to the population as a whole. Consent will be sought at this point.~      Patients will be transferred to theatre, anaesthetised and operated on as per normal~     practice. Inclusive of this, in accordance with NICE guidelines, patients will have a nasal~     or oesophageal Doppler probe inserted to accurately measure core temperature. At this point,~     patients enrolled in the study will have temperature measurements taken every minute from the~     oesophageal probe and non-contact thermometers.~      If the patients requested it previously, they will be informed of the results of the study at~     a later date.~      Statistics will then be carried out on the data to compare accuracy of the two novel methods~     to the oesophageal probe.~   "
6837|NCT03477344|"~     We designed a prospective, double blind, randomized, controlled versus placebo study to~     evaluate the efficacy of nightly low dose of Dexmedetomidine infusion to promote sleep and~     lower delirium in a population of post cardiac surgery patients. This population is~     characterized by longer ICU stay, more physical restraints such as catheters and drains, pain~     and sleep deprivation. It is associated with higher prevalence of Delirium and agitation~     leading to exposure to severe agitation related adverse events.~   "
6838|NCT03477331|"~     The main goal of the OptimAT study main goal is to validate a PBPK model for 3 direct oral~     anticoagulants (rivaroxaban, apixaban, dabigatran) and 3 P2Y12 inhibitors (clopidogrel,~     ticagrelor, prasugrel) in hospitalized patients.~   "
6839|NCT03477318|"~     The study purpose is to assess the accuracy of experienced endoscopists at a community~     hospital in predicting histological types of polyps resected at colonoscopy using white~     light. Patients 50 years or older undergoing first-time screening colonoscopy will be~     included in this observational study.~   "
6840|NCT03477305|"~     BerryCare teaches people about the health benefits of blackberries, how to harvest and~     maintain blackberry bushes and then assesses changes in knowledge and behaviors associated~     with blackberries and physical measurements.~   "
6841|NCT03477292|"~     There is evidence that using shorter antibiotic regimens may help in decreasing antimicrobial~     resistance and reducing drug-related adverse events.6 Moreover, short-course treatments were~     found to be as effective as longer-course antibiotic treatment.7,8 In a pooled analysis of~     four randomized trials in VAP comparing shorter versus long duration of antibiotics in the~     management of VAP, no difference in the mortality was found. We hypothesize that the use of~     short course of antibiotics in the treatment of VAP due to drug resistant Acinetobacter~     baumanii (sensitive to carbapenems and/or colistin only) may result in a higher~     antibiotic-free days and drug related adverse events, in comparison to a longer duration of~     antibiotics. In this study, we propose to study a 7-day versus 14-day course of antibiotics~     in patients with drug-resistant Acinetobacter baumanii.~   "
6842|NCT03477279|"~     There is promising evidence that couple-based approaches within Malawi's Option B+ prevention~     of mother to child transmission program could address help address 1) poor male engagement in~     the HIV continuum of care, 2) low male adoption of biomedical HIV prevention approaches, 3)~     sub-optimal female engagement in the continuum of care, and 4) poor or uncertain infant~     outcomes. Our team has developed an intervention to address these challenges, and will~     conduct a randomized controlled trial (N=500 couples) to assess intervention effectiveness at~     one year.~   "
6843|NCT03477266|"~     Giving women one day before and immediately after cesarean section a mouthly dissolving~     mosapride tablets 2every every 8 hours for maximum of 5 days ,or getting recovered~     gastrointestinal functions And assess preoperative gastrointestinal functions~   "
6844|NCT03477253|"~     This study was aimed to assess the outcome of laparoscopic cholecystectomy in acute calculous~     cholecystitis in terms of conversion rates, postoperative complications and length of~     hospital stay within and after 3 days of symptoms onset.~   "
6845|NCT03477240|"~     Cross-sectional Feasibility study on all consecutive patients of locally advanced cancer of~     the cervix or vault treated entirely at Tata Memorial Centre with curative intent radiation~     or chemoradiation.~   "
6846|NCT03477227|"~     A prospective comparative randomized multicentre non-inferiority trial. The purpose of this~     study is to compares of a short compression hosiery (stocking without a foot, compression~     class 2) with standard compression class 2 stockings for 7 days after the endovascular~     radiofrequency ablation of great saphenous vein with phlebectomy varicose tributaries.~   "
6847|NCT03477214|"~     Urinary incontinence (UI) and overactive bladder (OAB) in women has high prevalence which is~     increasing with the age. In adults aged 40 and older in the US demonstrated prevalence rate~     of 27.2% among man and 43.1% among women, respectively. Urine Incontinence was reported to~     affect 15% of women ages 40 to 49, 25% ages 60 to 69, and 38% of women age 80 and older.~   "
6848|NCT03477201|"~     Stray energy transfer during laparoscopic surgery is recognized as a cause of potentially~     serious complications. This will be the first study to demonstrate clinical evidence of~     tissue injury due to stray energy transfer during robotic surgery. This information can then~     be used to define surgeon modifiable factors that can reduce the risk of patient injury. In~     addition, these data can guide the development of future robotic and laparoscopic platforms.~   "
6849|NCT03477188|"~     This study was planned to evaluate the effects of somatosensory and vestibular rehabilitation~     additional conventional therapy on balance in patients with acute stroke.~   "
6850|NCT03477175|"~     This study will be conducted to assess the long-term safety of study drug(s) in participants~     who are enrolled in Eisai-sponsored lenvatinib studies.~   "
6851|NCT03477162|"~     This is a presurgical (proof of principle, window of opportunity) study in patients with~     surgically resectable thoracic tumors to determine steady-state tissue and plasma~     concentrations of metformin.~   "
6908|NCT03476421|"~     Since the previous decade, the authors introduced the R1 vascular (R1vasc) resection for the~     treatment of hepatocellular carcinoma (HCC), and colorectal liver metastases (Torzilli et al.~     J Am Coll Surg 2005; Viganò et al. Ann Surg Oncol 2016; Torzilli et al. Surgery 2017).~     However, oncological reliability of tumor exposure in surgery for HCC remains controversial~     since it has never been validated. The aim of the study is to determine the oncological~     adequacy of R1vasc hepatectomy in patients with HCC.~   "
6852|NCT03477149|"~     The EASYX™ Liquid Embolic is a new injectable, precipitating polymeric agent for the~     obliteration of vascular spaces through direct puncture or catheter access performed under~     X-ray guidance. The embolic liquid is an iodinized Polyvinyl Alcohol (PVA) Polymer ether.~     Iodine groups are covalently grafted to the PVA polymer backbone, whereby a stable~     nondegradable polymer with the desired features is created. The resulting polymer is~     dissolved in Dimethyl Sulfoxide (DMSO). EASYX™ is CE-marked since December 2016 and has been~     used in humans a few time for type II endoleaks, portal vein and varicocele (<10 cases at the~     date of submission). The purpose of this study is to evaluate the safety and efficacy of~     EASYX™ embolization liquid for the percutaneous treatment of vascular lesions, i.e.~     embolization of varicocele, type II endoleaks, portal vein before surgery, active peripheral~     bleeding or angiomyolipoma (AML).~   "
6853|NCT03477136|"~     vitamin D may have multiple functions, one of them is modulating reproductive processes and~     the reproductive role of vitamin D is highlighted by expression of the vitamin D receptors in~     testis, male reproductive tract and sperms~   "
6854|NCT03477123|"~     The objective of the study is to assess the efficacy of the Exo-H2 robotic exoskeleton for~     walking rehabilitation of people with incomplete spinal cord injury.~   "
6855|NCT03477110|"~     This pilot early phase I trial studies the side effects of temozolomide, radiation therapy,~     and tumor treating fields therapy using Novo tumor treatment fields (TTF)-200A device in~     participants with glioblastoma. Drugs used in chemotherapy, such as temozolomide, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Radiation therapy uses high energy~     x-rays to kill tumor cells and shrink tumors. NovoTTF-200A device is a portable device that~     produces alternating electrical fields that may disrupt growth of cancer cells. Giving~     temozolomide, radiation therapy, and tumor treating fields therapy using NovoTTF-200A device~     may work better in treating participants with glioblastoma.~   "
6856|NCT03477097|"~     The life expectancy of the Taiwanese reached 75.98 years in males and 82.65 years in females~     in 2011. Because of the improved longevity and low birth rate, proportion of elderly~     population increased to 11.15% in our society. It is expected to be 21.2% in 2016. Frailty~     syndrome is an important path to disability or mortality in the elderly. Increase on~     disability will become a great burden to the society. This trend of population aging~     phenomenon occurs worldwide.~      Frailty syndrome was defined by Fried el al. as older adults meet 3 of the following 5~     conditions: (1) unintentional weight loss over 10 lbs in previous year, (2) weakness (grip~     strength at the lowest 20% by gender and BMI), (3) exhaustion (self-reported), (4) slowness~     (at the lowest 20% by gender and height), and (5) low physical activity. However, the~     definition of frailty is under discussion worldwide.~      The sociological significance of frailty is that elders facing their changing roles in the~     society due to the changing position within the societal structure (i.e. moving from playing~     nuclear roles to marginal roles involuntarily or voluntarily) may potentially experience~     decline in psychosocial and physical well beings. Psychosocial and lifestyle factors and~     biomarkers are not well studied with respect to frailty. It is crucial to understand the~     social and biological risk factors of frailty and to design and study the possible prevention~     strategy for the prevention and management of frailty.~      Therefore, the investigators propose to use randomization trials to investigate (1) the~     developmental process of frailty, the psycho-social determinants, related biomarkers and~     lifestyle factors; (2) the non-pharmaceutical intervention on preventing the progression of~     frailty and the cost-benefit of the intervention.~      The investigators expect to (1) identify social determinants, biological and lifestyle~     factors which are associated with the development of frailty; (2) design and test clinical~     strategies to prevent frailty progression and (3) estimate the cost-effectiveness of the~     intervention. The results will have implications in public health education and in health~     policy making in order to prevent and to manage frailty in the elderly.~   "
6857|NCT03477084|"~     The continuing spread of extended-spectrum beta-lactamase-producing Enterobacteriaceae~     (ESBL-PE) is among the most important problems in antimicrobial resistance. It is also a good~     model to investigate the epidemiological complexity of resistance in Enterobacteriaceae.~     Available data on the transmission determinants of ESBL-PE in community settings are scarce,~     methodologically limited and mostly based on single centre studies. A comprehensive~     investigation using present typing and modelling techniques is warranted to develop a sound~     quantitative understanding of the interactions involved. A consortium of investigators with~     diverse expertise from countries with high and low endemicity of ESBL-EP has been created.~     Transmission and persistence of ESBL-PE within households and long-term care facilities will~     be studied. Individual and group-level determinants for transmission and persistence will be~     quantified, together with other ecological variables including environmental, food and~     wastewater contamination. Advanced molecular typing techniques and state of the art~     analytical methods will be used. Data generated in this project will directly inform a suite~     of mathematical models which, in addition to encapsulating current understanding of the~     processes, will be used to explore the potential effectiveness of different interventions to~     control ESBL-PE spread. The expected outputs are a comprehensive characterisation of ESBL-PE~     transmission considering bacterial clones and mobile genetic elements, as well as individual~     and ecologic-level factors in different settings, to inform public health authorities about~     interventions that should be prioritised to control transmission of these organisms.~   "
6858|NCT03477071|"~     Stenosis of the renal graft arteries occurs in 1 to 26% of cases and can damage the graft.~     Endovascular treatment is first-line treatment. The main objective of this study is to~     identify the predictive factors of failure of peri-anastomotic.~   "
6859|NCT03477058|"~     The aim of the study is to evaluate the cosmetic features of the product WO 3308 by means of~     a questionnaire in an interview situation after two weeks of product treatment, giving~     special consideration to the cosmetic performance, efficacy and skin compatibility and with~     special focus on the reduction of pruritus. Additionally the tolerance will be evaluated by a~     dermatologist.~   "
6860|NCT03477045|"~     Fish oil and oily fish contain omega 3 long chain polyunsaturated fatty acids known to be~     beneficial to health. Many people consume little, despite UK government recommendations to~     eat at least one portion of oily fish per week. Furthermore, despite modest consumption, fish~     stocks are declining due to over fishing. Therefore, there is a need for an alternative,~     sustainable and cost efficiently produced dietary source. A seed oil source of these fish~     oil-type fatty acids has been achieved by adding genes from other plant sources to the oil~     seed plant Camelina sativa. Camelina sativa, related to mustard and cabbage, has provided~     seed oil for human consumption for thousands of years. It was the most important oil seed~     plant in Europe until the 1900's. This research is being done to see if consuming fish~     oil-type fatty acids in Camelina seed oil allows the body to take up and use the fish oil~     fatty acids in the same way as it does from fish oil.~   "
6861|NCT03477032|"~     This is a prospective observational cohort study evaluating the the use of faecal microbiota~     transplantation amongst patients with Inflammatory Bowel Disease and Microscopic Colitis~   "
6862|NCT03477019|"~     The aim of this clinical trial is to investigate whether the therapeutic response of~     chemotherapy can be improved by focused ultrasound and microbubbles. Patients with liver~     metastases from breast cancer and colorectal cancer will be included. Computer Tomography~     (CT) will be performed as a baseline scan before treatment start. Two metastases in each~     patients liver will be preselected and randomized to either target lesion to be treated or~     control lesion to serve as internal control. The patients will receive conventional~     treatment with chemotherapy according to national guidelines. After intravenous chemotherapy~     infusion the patients will receive the experimental treatment. The target lesion will get~     focused ultrasound (FUS). Simultaneously repeated bolus-doses of microbubbles will be~     administered intravenously. The investigators will measure the difference in response between~     FUS- treated and -untreated lesions on the post-treatment CT scan.~   "
6863|NCT03477006|"~     Despite advances in trauma resuscitation, a paucity of therapeutic interventions are~     available early enough to reduce the downstream morbidity and mortality attributable to~     hemorrhage, shock and coagulopathy. Due to the time sensitive nature of the treatment of~     hemorrhage, the ideal resuscitation intervention would entail use of a blood product~     containing all essential hemostatic components, closest to time of injury, where prevention~     or reversal of the devastating downstream consequences of shock and coagulopathy can occur.~     This proposal will characterized the efficacy of whole blood resuscitation initiated in the~     prehospital setting to patients in hemorrhagic shock which represents this ideal intervention~     post-injury. These results will have great potential to dramatically change the way trauma~     resuscitation occurs today.~   "
6864|NCT03476993|"~     BCD-085 is an innovative drug, anti-interleukin-17 monoclonal antibody. The aim of the study~     is to evaluate the efficacy and safety of BCD-085 in patients with primary biliary~     cholangitis (PBC).~   "
6865|NCT03476980|"~     An extension of the PREMOD2 trial, the PREMOD2 Follow-Up trial will evaluate the~     neurodevelopmental outcomes at 22-26 months corrected age of preterm children who received~     UCM or DCC.~   "
6866|NCT03476967|"~     This study analyzed diabetic patients without evidence of glaucoma who underwent panretinal~     photocoagulation to determine the effect on optic disc topographic parameters in~     non-glaucomatous patients with proliferative diabetic retinopathy (PDR).~   "
6867|NCT03476954|"~     This is a non-randomized phase 2 study designed to asses the mean flow velocity (MFV) and~     cerebral blood flow (CBF) response to non-invasive respiratory impedance.~   "
6868|NCT03476941|"~     Intra-abdominal abscesses are pus-filled pouches in the abdominal cavity. Current standard of~     care includes drain placement in the abscess cavity to reach source control as well as~     administration of systemic antibiotics. It is common practice to flush the drain on a daily~     basis to ensure patency. This study aims to analyze the clinical impact of a higher local~     concentration of antibiotics (rather than normal saline) provided through drain irrigation~     with an antimicrobial agent (Gentamicin and/or Clindamycin) compare to normal saline.~   "
6869|NCT03476928|"~     To evaluate the safety and efficacy of vilaprisan in Japanese subjects with uterine fibroids~     and heavy menstrual bleeding (HMB).~   "
6870|NCT03476915|"~     Developmental dysplasia of the hip (DDH), formerly known as congenital dislocation of the~     hip, comprises a spectrum of abnormalities that include abnormal acetabular shape (dysplasia)~     and malposition of the femoral head.~   "
6871|NCT03476902|"~     The purpose of this study is to evaluate the feasibility, acceptability, and potential~     usefulness of using a mobile application (nOCD) for treatment of obsessive compulsive~     disorder (OCD) in a sample of 25 adults (ages 18-65) in an 8 week trial. nOCD is a free~     iOS/Android application that provides treatment strategies. The study team will evaluate the~     effect of the application using gold-standard clinician-administered and self-report~     measures. Prior to downloading the application, participants will receive 4 (up to 5)~     in-person visit (orientation to the app and psychoeducation) and receive brief weekly phone~     check-ins. The long-term goal of this study is to use this information to develop new~     treatments for patients with OCD. All study procedures will be conducted on site at the New~     York State Psychiatric Institute.~   "
6872|NCT03476889|"~     A randomised, controlled, double-blind, parallel group, multi-country study to investigate~     the safety and tolerance of a partly fermented infant formula containing prebiotic~     oligosaccharides in healthy term infants.~   "
6873|NCT03476876|"~     Diabetes-related foot ulcers (DFUs) are a leading cause of hospitalization and amputation~     worldwide, and account for 33% of all direct costs of diabetes care in the US. Ulcers~     requiring acute care can result in treatment costs of up to US$70,000 per event, varying with~     the severity of the wound. Once the skin is ulcerated, it is susceptible to becoming infected~     and ultimately amputation in particular in case of deep DFUs. To manage the cost and avoid~     hospitalization and amputation, wound should be immediately closed. But this is often~     challenging in diabetic foot with deep ulcers.Wound healing is a dynamic process involving~     interactions between cells, extracellular matrix (ECM) and growth factors that reconstitutes~     tissue following injury. ECM plays an important role in tissue regeneration and is the major~     component of the dermal skin layer. Recognition of the importance of the ECM in wound healing~     has led to the development of wound products that aim to stimulate or replace the ECM in~     particular in case of deep tissue destruction because of deep DFUs. It is known from the~     literature that chronic or hard-to-heal wounds are characterized by a disrupted or damaged~     ECM that cannot support wound healing. Thus treatment strategies based on use of biologic~     scaffold materials for management of chronic and deep wounds has increased dramatically~     during the past two decades. These scaffolds include those comprising an intact extracellular~     matrix (ECM) or individual components of the ECM, and those comprising hybrids incorporating~     a synthetic component with a biologic component. DermACELL (LifeNet Health,Virginia Beach,~     VA) is acellular dermal matrices (ADM), which has been shown to be effective in treating~     chronic DFUs in a clinical trial.~      Another ADM product available in the market is made by Integra® (Bilayer Matrix Wound~     Dressing, Integra LifeSciences). However, advantages/disadvantages of one compared to the~     other are unclear. In addition, prior studies often focused on wound healing outcomes (e.g.~     time to heal, success of wound healing) without considering patient-centered and~     physician-centered outcomes such as time and difficulty to apply, likelihood of adverse~     events and need for reapplication, poor tissue mechanics outcomes (e.g. presence of scarring~     or tissue biomechanics properties leading to increase in shear or pressure post healing thus~     increasing likelihood of recurrence of the ulcer), and other patient centered outcomes like~     smell, pain, and comfort.~      The primary objective of this prospective, randomized trial is to compare the outcomes of~     DermaCELL with Integra. The investigators assumed that the wounds outcomes (e.g. weekly wound~     size change, time to heal, time to successful wound granulation) are comparable between~     DermaCELL and Integra. However, from operation and patient centered outcomes, there may be~     some noticeable differences. For instance, DermaCELL, thanks to its mesh structure, thin~     thickness, and no need for hydration, may be easier to apply with shorter time than Integra.~     The factors are of key importance in operation room (OR) setting and could reduce overall~     cost of application and needs in using OR resources. Other important outcomes least addressed~     in prior studies are number of grafts failing, adverse events (e.g. amputation, infection,~     etc), cost of wound healing treatment, tissue biomechanics, which may lead to recurrence of~     ulcers (e.g. formation of tissue scarring), and other patient-centered outcomes (e.g. pain,~     quality of sleeping, wound smelling, etc). For instance, many patients are unhappy with~     smelling of wounds, which make them embarrassed among their family members like grand kids.~     Thus reducing wound smelling during activities of daily living is often considered as an~     important patient centered outcomes.~   "
6874|NCT03476863|"~     Worldwide there is a high prevalence of morbid obesity with a progressive increase in~     incidence in recent years, causing serious consequences for the health services.~     Approximately 12% of the world population is obese and Brazil is in 77º without world ranking~     of countries in cases of obesity. In this context, bariatric surgery appears as an effective~     method of treating refractory obesity. Support of high fractions of oxygen administered~     during anesthesia is produced, it accepts the use of Positive Positive Positive Pressure~     (PEEP) through the Alveolar Recruitment Maneuver (ARM), which has been used allowing small~     fractions inspired by oxygen, which reduces intra-and postoperative atelectasis and optimizes~     gas exchange during anesthesia. In order to better monitor ventilatory mechanics, Electrical~     Impedance Tomography (EIT) appears as a cheap imaging method when compared to a non-invasive~     magnetic resonance imaging (CT) or MRI, with no side effects and recent studies shown in its~     life as pneumothorax , MRA monitoring, collapse detection, and PEEP titration. The aim of~     this study is to evaluate the impact of ARM and its repercussions on lung function and~     respiratory mechanics. This is a randomized controlled clinical trial with patients~     undergoing videolaparoscopic gastroplasty surgery, of both sexes. Patients were randomly~     assigned to Control Group and Experimental Group. Patient evaluation is performed without~     before, during and postoperative, through a pulmonary function test and EIT.~   "
6875|NCT03476850|"~     To evaluate quadratus lumborum block effect on post operative pain scores during the first 24~     hours after surgery as compared to transversus abdominis plane block after laparoscopic donor~     nephrectomy patients.~   "
6909|NCT03476408|"~     Cerebellar vermis anomalies are present in schizophrenic individuals. This condition leads to~     postural balance problems. Foot and ankle complex have a special role for maintaining~     balance. However, there is no study about this topic in schizophrenic individuals.~   "
7106|NCT03473834|"~     A feasibility study using measures of turning function derived from Inertial Measurement Unit~     sensory before, and after, a modified exercise programme approach.~   "
6876|NCT03476837|"~     Secondhand smoke exposure in the home can causes sudden infant death syndrome (SIDS), asthma,~     respiratory illnesses, and ear infections in children. In addition to cigarette smoke,~     exposure to other tobacco products can further compromise the safety of children in the home.~     This study aims to reduce the burden of multiple tobacco exposures, improve access to~     preventive care, and reduce the disproportionate risk for chronic diseases, including cancer,~     among African American women and children living in the Arkansas Delta region. Our central~     hypothesis is that messages delivered by a community health worker that aim to modify~     knowledge, attitudes, beliefs, and subjective norms may influence the perceived threat of~     tobacco exposures and provide cues for African American women caregivers to implement~     comprehensive smokefree policies to protect their children from the harms of tobacco and~     in-turn, influence their quitting.~   "
6877|NCT03476824|"~     The aim of the project is to predict the patient under conservative therapy as a function of~     the patient Classification of Rommens and Hofmann and other potential prognostic factors. A~     corresponding prognostic score may be used in the future by patients and attending physicians~     support joint decision between surgical and conservative treatment.~   "
6878|NCT03476811|"~     Post-operative pain following lumbar spine fusion is frequently difficult to manage and can~     lead to increased doses of opiate pain medications to control pain. In this study, the use of~     subcutaneous local anesthesia will be studied to determine its efficacy at reducing~     post-operative pain following spinal fusion surgery.~   "
6879|NCT03476798|"~     This is a phase II study of rucaparib, a small molecule inhibitor poly (adenosine diphosphate~     [ADP]-ribose) polymerase (PARP), being tested in combination with bevacizumab in patients~     with recurrent cervical or endometrial cancer. The objective of this study is to determine~     the proportion of these patients who survive progression-free for at least 6 months while~     receiving this drug combination.~   "
6880|NCT03476785|"~     The purpose of this study is to determine whether vigorous exercise training 4-5 days/week~     for one year in sedentary middle aged (ages 40-64) individuals at high risk for future~     development of heart failure will improve cardiac and vascular compliance to a degree~     equivalent to life-long exercisers and the sedentary young. To date, no effective therapy for~     heart failure with preserved ejection fraction (HFpEF) has been found; therefore prevention~     is critical and discovering novel treatment strategies is essential. Exercise training if~     implemented in high risk patients may improve diastolic function and cardiac-vascular~     interactions, preventing further progression to overt heart failure.~   "
6881|NCT03476772|"~     Caudal aneasthesia for pediatric surgery was first reported in 1933. Since then, studies have~     described the indications for pediatric caudal block, the level of analgesia, doses,~     advantages and disadvantages of this technique.~      In children, caudal anesthesia is most effectively used as adjunct to general aneasthesia and~     has an opioid-sparing effect, permitting faster and smoother emergence from aneasthesia.~      A single shot caudal anesthesia provides relatively brief analgesia for 4 to 8 hours~     depending on the agent used. Prolongation of anesthesia can be achieved by adding various~     adjuvants, such as opioids and nonopioids such as clonidine, ketamine, midazolam, and~     neostigmine,with varying degrees of success.~   "
6882|NCT03476759|"~     2groups with peritoneal adhesions after cesarean delivery will be allocated to either~     laparoscopic tubal adhesiolysis or to IVF/ICSI~   "
6883|NCT03476746|"~     This is a phase 1, single centre trial in Japanese healthy male subjects comparing the amount~     of active ingredients of LEO 90100 foam and Dovobet® ointment in the stratum corneum.~   "
6884|NCT03476733|"~     Drug Related Problem (DRP) is defined as an event that may potentially affect the health~     outcomes in the patients. DRPs can occur at all stages of the medication usage process~     starting from prescribing to dispensing stage. Lack of follow-ups and reassessment of~     therapeutic outcomes may also contribute to DRPs. Pharmaceutical care is a co-operative~     activity in concert with other health care professionals and offered directly to the patient~     for improved quality use of medicines and achieving achieve the desired therapeutic outcomes.~     Pharmaceutical care identifies and resolves actual or potential DRPs.~      DRPs pose a challenge to the clinician, and that may affect patient's clinical outcomes and~     may result in morbidity or mortality and increased health care costs. Health care costs may~     become a burden to the patient or may be to the government or to the third parties. Clinical~     Pharmacy is a discipline that promotes the quality use of medicines through evidence-based~     medicine and helps in identification and resolving DRPs. A clinical pharmacist through~     his/her clinical accuracy checking may identify DRPs and come out with suitable solutions to~     resolve the same.~      Consequently, the aims of our study were to assess prevalence and characteristics of DRPs~     identified in inpatient and to identify factors associated with DRPs.~   "
6885|NCT03476720|"~     Manufacturer's diagrams showing defibrillation pad positioning (as used on public access~     defibrillators) are anatomically incorrect and are likely to lead to poor position of~     defibrillation pads, with reduced defibrillation efficacy.~      We will ask untrained members of the public to observe the diagrams and place pads as~     indicated on the diagram. We will asses the accuracy of pad placement and repeat the study~     using an anatomically correct diagram to see if we can improve the accuracy of pad placement.~   "
6886|NCT03476707|"~     The objective is to measure the adjusted association between preoperative anemia and total~     hospital costs. We hypothesize that patients with anemia before surgery will have higher~     hospitalization costs than people without anemia.~   "
6887|NCT03476694|"~     Brachial plexus block as done by landmark technique use large volume of local anaesthetics~     (at least 30-40 ml), leading to higher incidence of phrenic nerve involvement and~     diaphragmatic dysfunction. With use of ultrasound dose of local anaesthetic can be reduced.~     Volume as low as 20 ml when use by ultrasound guidance has shown to provide successful block~     with no hemidiaphragmatic palsy when compared with nerve stimulation technique. But no study~     has compared the different volumes of drug on success rate and diaphragmatic motility.So in~     this study , the investigators want to compare the incidence of hemidiaphragm paralysis and~     success of block with different volumes of local anaesthetic , so that the lowest effective~     dose with higher safety profile can be determined.~   "
6888|NCT03476681|"~     This is an open label, first-in-human, phase 1, dose escalation study to determine the safety~     including dose limiting toxicity (DLT) and maximal tolerated dose of the monoclonal antibody~     NEO-201 in adults with solid tumors (cancer) which has not responded to standard treatments.~   "
6891|NCT03476642|"~     The primary objectives of this study are to define the extent of dermatomal anesthesia and~     anatomical spread of injectate (as defined by MRI imaging) that is provided by an ESP block~     at the T5 level, using twenty milliliters of 0.5% ropivacaine.~      The secondary objectives include: 1) the measurement of changes in hemodynamic parameters~     associated with the ESP block, 2) the duration of sensory effects provided by ropivacaine~     with or without epinephrine, 3) the venous plasma concentration of ropivacaine associated at~     various time intervals after completion of the ESP block.~   "
6892|NCT03476629|"~     Although there has been some progress in pharmacological management of PAH, limited~     functional capacity and low survival still persist, but there is evidence that exercise~     training can be accomplished without adverse effects or damage to cardiac function and~     pulmonary hemodynamics. Specifically, improvements in symptoms, exercise capacity, peripheral~     muscle function and quality of life. Training programs need to be better studied and well~     defined, and their physiological effects during physical training and functional capacity.~      The aim of this study is to compare the effects of different training exercises on physical~     performance indicators.~   "
6893|NCT03476616|"~     Obesity is a complex metabolic state at which many pathophysiological pathways seem to~     interfere, like imbalance of autonomic nervous system, as well as~     renin-angiotensin-aldosterone system (RAAS) activation. Latest studies have shown that the~     increase of peripheral fat in obese patients, alongside with the increase of P-450 aromatase~     leads to hyper-aldosteronism, which results to increased sodium intake and rise of blood~     pressure. The present study aims to investigate the potential superiority of an aldosterone~     antagonist based therapy (eplerenone) over the renin-angiotensin antagonists (ARBs)~     (valsartan) based therapy in hypertensive obese patients regarding reduction of blood~     pressure (office, home and ambulatory) over a 24-week period.~   "
6894|NCT03476603|"~     Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the~     pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the~     pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery.~     Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological~     availability of medication. In this study the pharmacokinetic effects of bariatric surgery on~     irbesartan are investigated.~   "
6895|NCT03476590|"~     Heart failure (HF) is characterized by high mortality, poor quality of life and frequent~     hospitalizations. The effectiveness of out-patient care for HF patients is unsatisfactory.~     Therefore the solutions that enable effective monitoring and assessment of HF patients'~     clinical status become priority in treatment strategy. The applicant proposes to develop a~     model of care for HF patients based on modern non-invasive diagnostic tools and telemedicine.~     Clinical evaluation will be based on i.e. impedance cardiography, a simple non-invasive~     method of hemodynamic monitoring, including assessment of heart rate, blood pressure, left~     ventricular stroke volume, chest and total fluid status. The telemedicine system will enable~     rapid, appropriate to the patient's clinical status, therapeutic decision undertaken remotely~     by specialist. Implementation of the proposed model of care will contribute to a significant~     improvement in prognosis of HF patients (through i.e. improved access to specialist~     consultation, the early diagnosis of the deterioration of HF and the optimization of~     treatment). The significant economic, social and scientific benefits related to the project~     are also expected.~   "
6896|NCT03476577|"~     Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the~     pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the~     pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery.~     Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological~     availability of medication. In this study the pharmacokinetic effects of bariatric surgery on~     ibuprofen are investigated.~   "
6897|NCT03476564|"~     Our findings will provide preliminary clinical evidence to suggest the new experimental~     treatment approaches, toward female factor infertility treatment with pentoxyfylline.~   "
6898|NCT03476551|"~     Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the~     pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the~     pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery.~     Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological~     availability of medication. In this study the pharmacokinetic effects of bariatric surgery on~     hydrochlorothiazide are investigated.~   "
6899|NCT03476538|"~     Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the~     pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the~     pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery.~     Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological~     availability of medication. In this study the pharmacokinetic effects of bariatric surgery on~     gabapentin are investigated.~   "
6900|NCT03476525|"~     Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the~     pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the~     pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery.~     Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological~     availability of medication. In this study the pharmacokinetic effects of bariatric surgery on~     fluoxetine are investigated.~   "
6910|NCT03476395|"~     The shoulder joint is the second most affected body part of all overuse injuries in overhead~     athletes. Due to the repetitive throwing motion overhead athletes show the following~     characteristic adaptations of their dominant shoulder: Loss of internal rotation (IR) and~     gain of external rotation (ER), reduced muscle strength of the shoulder external rotators and~     scapular dyskinesis. On the one hand these adaptations are normal and necessary for a~     powerful throwing performance. On the other hand the amount of adaptation seems to play a~     crucial role in developing overuse symptoms and therefore becoming a risk factor. Most~     previous studies investigating throwing specific adaptations and risk factors focused on~     overhead sports like baseball, handball or tennis, whereas similar research in volleyball is~     still insufficient. Therefore the aim of this study is to evaluate if sport specific~     adaptations are present in female volleyball players and if yes, if there is a difference of~     the extent of these adaptations in volleyball players with overuse symptoms and players~     without.~   "
6901|NCT03476512|"~     It is estimated that more than 70% of patients on antihypertensive medications do not take~     them as prescribed. Treatment non-adherence practice may be particularly higher in developing~     countries where there is poor accessibility to medicines and healthcare services, coupled~     with low level of awareness of the lifelong nature of hypertension treatment among patients.~     Optimal control of blood pressure has been reported to reduce the incidence of morbidity and~     mortality associated with hypertension. Thus, adoption of healthy lifestyle as well as~     ensuring regular and continuous adherence to prescribed medications are integral to~     successful management of hypertension to achieve the target blood pressure goals.~      The present study comprehensively evaluated adherence to pharmacotherapy and~     non-pharmacological measures among ambulatory hypertensive patients attending two healthcare~     institutions in Sokoto, Northwestern Nigeria. Reasons for treatment non-adherence were~     evaluated, while perception and beliefs about hypertension and its management were also~     explored, with pharmacist-led patient-specific adherence education provided as appropriate to~     resolve the knowledge gap(s). Association between treatment adherence and blood pressure~     outcome at contact and the subsequent 2-months clinic appointment were investigated.~      Patients aged 18 years and above, with a primary diagnosis of hypertension, and who were on~     antihypertensive medications for at least 3-months were recruited from the medical outpatient~     clinic of Usmanu Danfodiyo University Teaching Hospital and the Specialist Hospital, both~     within Sokoto metropolis, Sokoto state, Northwestern Nigeria. Newly diagnosed patients,~     in-patients and those who declined participation were excluded from the study.~   "
6902|NCT03476499|"~     Skin flaps following mastectomy breast surgery that do not have enough oxygen are at risk for~     necrosis which can increase wound healing problems, postoperative recovery time and be costly~     to the hospital systems and affect the patient quality of life, poor esthetic results and~     overall reconstructive success. Mastectomy skin flap necrosis (MSFN) has an incidence of~     10-15% with higher rates (7% - 30%) in mastectomy procedures with immediate reconstruction.~     Intraoperative assessment of the circulation in skin flaps is currently done with clinical~     assessment tools utilizing somewhat subjective identifiers such as flap color, capillary~     refill, temperature and dermal edge bleeding to determine the viability of the flap. Several~     technologies have been developed to assist in the clinical judgement of skin flaps but these~     technologies are not yet widely used because of the cost of the technology, the time required~     to image the patient, the intravenous injection of indocyanine green (ICG) dye required for~     contrast and the inability to image repeatedly and in different environments (pre-op,~     intra-op and post-op). A new commercially available imaging technology uses NIR spectroscopy~     to measure regional tissue hemoglobin oxygenation, using images that are taken 12 inches away~     from the patient. Preclinical data shows that NIR can predict necrosis in flaps but clinical~     data is needed to characterize and assess the value of the technology in plastic and~     reconstructive surgery. The purpose of this research study is to explore the ability of NIR~     imaging to predict skin flap tissue viability in the clinical setting of immediate breast~     reconstruction procedures. Study Design: This is a prospective, non-interventional study that~     will explore the ability of NIR imaging to predict of tissue viability in immediate breast~     reconstruction procedures. Necrosis will be scored using the SKIN score. Participation in the~     study will not impact patient care; all patients will receive standard care.~   "
6903|NCT03476486|"~     Carpal tunnel syndrome occurs when a nerve gets pinched as it passes through a confined~     tunnel within the wrist and hand. It is the most commonly pinched nerve and often results in~     disabling hand numbness, tingling, pain and weakness. For moderate and severe cases, an~     operation is often performed that cuts the ligament that presses on the nerve. This surgery~     is generally very successful but involves a 2-5 cm long incision at the base of the palm.~     Recovery from the surgery usually takes 3-8 weeks. Ultrasound provides a clear noninvasive~     way of looking at the contents of the carpal tunnel. A technique has been developed whereby a~     wire thread is looped around the ligament using a needle guided by ultrasound. The ligament~     is cut by the wire below the surface of the skin. This technique results in 2 needle puncture~     holes instead of the open incision of the traditional surgery. The investigators have~     completed research on this technique in cadavers. It was confirmed that complete or almost~     complete cutting of the ligament can be safely and predictably accomplished. This research~     will look at the effectiveness of this looped thread technique of carpal tunnel release on~     patients who have carpal tunnel syndrome. Specifically, participants will be required to: 1.~     rate the severity of their carpal tunnel syndrome symptoms and disability using a standard~     questionnaire, 2. measure hand sensation, 3. measure pinch and grip strength tests of their~     hands, 4. undergo ultrasound measurements of the size of the pinched nerve at the carpal~     tunnel, and 5. undergo electrical tests to measure the nerves ability to conduct impulses~     across the carpal tunnel. These will be measured before the looped wire procedure and at 3~     and 6 months following the procedure. Recovery time will also be measured.~   "
6904|NCT03476473|"~     This study aims to evaluate the presence of lung function impairment in a sample of patients~     diagnosed with non-affective psychosis.~   "
6905|NCT03476460|"~     This phase II, open, non-inferiority, randomized and controlled clinical trial is aimed to~     ascertain the incidence of contrast nephropathy in outpatients undergoing CT scan with~     contrast.~      Patients will be randomized to receive oral prophylaxis with capsules of sodium chloride and~     free water ingestion or prophylaxis with sodium chloride 0.9% intravenous solution.~      The total dose (mmol) of sodium chloride will be the same regardless administration via. The~     contrast will be iodixanol.~      Patients >65 years, of both sexes, with at least one of the following criteria: diabetes,~     stable heart failure or chronic kidney disease (estimated glomerular filtration rate between~     30 and 60 ml/min), undergoing CT scan with contrast, and who give written informed consent,~     will be included in the study. Patients with estimated glomerular filtration rate <30 ml/min,~     serum potassium <3.5 mEq/L, infusion of iodine contrast in the previous 15 days,~     administration of nephrotoxic drugs in the previous 72 hours or expected in the following~     hours after contrast infusion, decompensated chronic conditions (heart failure, chronic~     obstructive pulmonary disease, hypertension), allergy to iodine contrast, or the presence of~     hyperchloremia or hypernatremia, will be excluded from the study.~      Contrast nephropathy will be defined as the increase of serum creatinine >0.3 mg/dL from~     baseline, or the reduction of estimated glomerular filtration rate (MDRD-4) >25% from~     baseline, in the first 48 hours after contrast administration.~   "
6906|NCT03476447|"~     The REMEDI Study is a single-center, prospective, double-blind, randomized,~     placebo-controlled trial of multiple doses of B. infantis EVC001 supplementation in healthy~     term breastfed infants.~   "
6907|NCT03476434|"~     Serrated polyposis syndrome (SPS) is the most common colorectal polyposis syndrome and is~     characterized by the combination of large and/or numerous serrated lesions (SLs) throughout~     the colorectum. SLs are classified into sessile serrated polyps (SSP) with or without~     dysplasia, hyperplastic polyps (HP) and traditional serrated adenomas (TSA). In 2010 the~     World Health Organization (WHO) defined this syndrome by any one of the following conditions:~     criterion I, at least 5 SLs proximal to the sigmoid colon with 2 or more of these being >10mm~     in size; criterion II, any SLs proximal to the sigmoid colon in a first-degree relative with~     SPS; criterion III, more than 20 SLs of any size distributed throughout the colon. It has~     been demonstrated that 11.8-28.5% of patients with SPS present with colorectal cancer (CRC)~     at diagnosis. Tandem colonoscopy studies have demonstrated that a significant number of~     lesions are missed during conventional colonoscopy. This finding is even more evident when~     focusing SLs where a 31% miss rate has been reported. SLs are often overlooked due to their~     typical appearance: flat morphology, similar colour to the surrounding mucosa, subtle and~     indistinctive borders. Chromoendoscopy (dye spraying onto the surface of the colon) enhances~     the detection of subtle and flat polyps in the colon. Until the date no studies have assessed~     the use of dye-based chromoendoscopy in SPS patients.~      The aim of this trial was to evaluate the usefulness of panchromoendoscopy with indigo~     carmine for the detection of polyps in the colon in patients with SPS. Secondary aims were to~     estimate the SLs and adenoma miss rates in these patients.~      Patients were randomized in a 1:1 distribution to one of the two arms of the study by a list~     of random numbers distributed by the coordinator center. After randomization, patients were~     submitted to tandem colonoscopies by the same endoscopist:~        -  In group A (HR-WLE) the first inspection was on high-resolution white-light endoscopy~          from the cecum/ileo-colonic anastomosis to the rectum, followed by a second inspection~          also on HR-WLE.~        -  In group B (HR-CE) the first inspection was on HR-WLE from the cecum/ileo-colonic~          anastomosis to the rectum, followed by a second inspection with panchromoendoscopy. For~          this, the lumen was sprayed in a segmental fashion using 0.4% indigo carmine delivered~          via a specially designed dye spray catheter (Olympus PW-5V1) or via the accessory~          channel with a 50cc syringe filled with indigo carmine and air. After allowing a few~          seconds for the dye to settle onto the mucosal surface, excess pools of indigo carmine~          were suctioned and the mucosa was then scrutinised.~      Time to withdrawal from the cecum was measured using a stopwatch excluding time needed for~     polypectomy and biopsies.~      Lesions detected during each inspection were described and then removed. Size (measured in~     comparison with an open biopsy forceps), morphology (using the Paris classification),~     location and polypectomy technique were recorded before removal. Histology was used as gold~     standard.~   "
6911|NCT03476382|"~     The hypothesis of this study is that since osteoarthritis of the knee is primarily a bone~     disease where the joint changes are secondary, and bone growth stimulators function to~     decrease intraosseous venous congestion and remodel bone, then there is a potential benefit~     for the treatment of osteoarthritis of the knee with bone growth stimulators.~   "
6912|NCT03476369|"~     During a percutaneous coronary intervention (PCI), Fentanyl is commonly used for sedation.~     Ticagrelor is also routinely used as anti-platelet agent during PCI. However, a recent study~     has demonstrated the decrease in effectiveness of Ticagrelor when administered along with~     Fentanyl. Hence this study was designed to further assess the interaction between crushed vs~     non crushed Ticagrelor and Fentanyl given during PCI procedures.~   "
6913|NCT03476356|"~     The purpose of the study to assess the efficacy of adding L-carnitine to clomiphene citrate~     for increasing the ovulation and the pregnancy rate in women with PCOS.~   "
6914|NCT03476343|"~     The purpose of the present study is to continue clinical scanning on the NICU MRI with~     improved administrative processes and procedures, thereby making medically indicated, state~     of the art/high end MRI exams available to all infants treated at CCHMC.~   "
6915|NCT03476330|"~     Fanconi anemia (FA) is an autosomal recessive disease characterized by progressive bone~     marrow failure, variable congenital abnormalities and a predisposition to malignancy,~     particularly acute myeloid leukemia (AML) and squamous cell carcinoma (SCC). Improved~     transplant outcomes are modifying the natural history of Fanconi Anemia. Improved transplant~     survival, no radiation exposure, and almost no GVHD increases the importance of addressing~     later SCC even further. The investigators hypothesize that quercetin will prevent or delay~     the development of SCC and associated complications, there by ameliorating or delaying the~     need for potentially lethal treatment with chemotherapy and/or radiation therapy for the~     same.~   "
6916|NCT03476317|"~     The purpose of this study is to determine the effect of a novel gut microbiota-targeted~     therapeutic regimen (bowel lavage and antibiotics with or without an antifungal) in the~     management of active Crohn's Disease (CD) that is refractory to conventional,~     immunosuppressive therapy.~   "
6917|NCT03476304|"~     Caries disease is still the leading cause of severe tooth decay. Since this can lead to tooth~     loss, it is important that appropriate treatment is advised to help prevent damage and~     maintain tooth health. Faced with major coronary destruction, several times it becomes~     necessary to perform the endodontic treatment, aiming to maintain the element in the buccal~     cavity for longer. It is known that an excellent restorative treatment with poor endodontic~     treatment and the inverse has a direct impact on the (in) success of the treatment. In this~     context, the proper cleaning of the root canals is highlighted, aiming the removal of~     bacteria and toxins. Acceptable restorations are those that provide adequate reestablishment~     of anatomy, function, proximal contacts, and occlusal stability. Traditionally, indirect~     restorations would be indicated in cases of extensive coronary destruction, because it was~     believed that they would present greater resistance and longevity when compared to direct~     restorations. However, contemporary dentistry admits that, thanks to adhesive and~     conservative principles, this difference between direct and indirect procedures in terms of~     longevity is not significant. The classic restorative procedure in cases of endodontically~     treated teeth with great loss of coronary structure involves the use of intraradicular~     retainers, followed by the creation of core and restoration through total crowns. Removal of~     healthy tissue for the use of posts can weaken the remaining dental structure and increase~     the risk of root perforations. In this sense, endocrown restorations show superiority when~     compared to those made with intraradicular retainers. Although the indications are favorable~     for the use of endocrown restorations, the clinical evidence available on the subject is~     still scarce. In this double-blind randomized clinical trial, patients who need and meet the~     inclusion criteria will will be allocated to one of the three restorative groups available,~     being endocrown restoration in semi-direct composite resin, direct restoration in composite~     resin retained on the post and ceramic crown retained in the post. Patients will be monitored~     annually after completion of restorative treatment outcome. In addition to treatment~     longevity, other secondary outcomes will be evaluated, such as patient satisfaction, impact~     on quality of life and cost-effectiveness of the proposed treatments.~   "
6918|NCT03476291|"~     The investigators expect to develop an algorithm that can interpret OCT images and automated~     determine whether the macula is normal or not by using OCT image-based deep learning~     techniques. And investigators wish to develop software applications that will help better~     screen and diagnose macular diseases in resource-limited areas.~   "
6919|NCT03476278|"~     Patient satisfaction is an important subjective measure of healthcare quality which~     contributes to evaluation of the structure, process and outcome of services. The key factor~     in patient satisfaction is adequate perioperative information of the patient and~     communication between healthcare providers and patient or patient's kin.~      There are few studies in anesthesia that have assessed patient satisfaction and mood-state~     during regional anesthesia.~      The investigators aimed to evaluate factors associated with patient satisfaction from~     regional anesthesia procedure and mood-state of patients who underwent surgery under regional~     anesthesia.~   "
6920|NCT03476265|"~     The aim of this study is to evaluate gastroesophageal reflux disease - health related quality~     of life (GERD-HRQL) after electrical stimulation of the lower esophageal sphincter (LES) in~     patients with gastroesophageal reflux disease (GERD) and esophageal dysmotility.~   "
6921|NCT03476252|"~     A number of inflammatory markers have been recognized, among which the acute phase reactant~     C-reactive protein showed a positive correlation with the risk of coronary artery disease in~     both healthy individuals and those at high risk .~      Pentraxin 3 is expressed in atherosclerotic plaques, mainly in macrophages and neutrophils,~     suggesting that pentraxin 3 may be involved in the progression of atherosclerotic plaque.~        -  A number of studies demonstrated that increased levels of Pentraxin 3 were associated~          with the presence and increased severity of coronary artery disease in clinically stable~          patients undergoing elective coronary angiography .~        -  Pentraxin 3 levels peak at about 7 h after acute MI, which is substantially earlier than~          CRP, and thus PTX3 could be a better independent predictor of CHD than CRP .~        -  Recently, it was shown that the number of the involved vessels, MI type, stent length,~          culprit lesion, and the need for PCI all had a significant relation with abnormal~          Pentraxin 3 levels , however, it was not studied with respect of its relation with~          postprocedural angiographic and clinical outcomes.~      We thought to evaluate the role of pentraxin-3 on the preprocedural determinants (Grace~     score, type of MI, culprit lesion, lesion length, pre-procedural TIMI flow, thrombus burden,~     severity and complexity of CAD as determined by Syntax score and procedural outcome~     (post-procedural TIMI flow, no reflow and myocardial perfusion assessed by myocardial blush~     grade as well as the inhospital clinical outcome of primary Percutaneous coronary~     intervention in patients with acute ST elevation myocardial infarction.~   "
6922|NCT03476239|"~     This study is being done to evaluate the rate of hematological response (complete~     remission/complete remission with partial hematological recovery [CR/CRh*]) induced by~     blinatumomab in Chinese adult subjects with relapsed/refractory B-precursor acute~     lymphoblastic leukemia (ALL).~      The study will consist of a screening period, a treatment period, and a follow-up period.~   "
6923|NCT03476226|"~     The purpose of this study is to determine whether patients experience a better quality of~     life when they have received education about coping strategies for cognitive dysfunction.~   "
6925|NCT03476200|"~     Stress is considered as a risk factor for physical and mental health. For this reason,~     interventional programs focused on stress management have been developed. These programs have~     proven to be efficacious modifying emotional variables and psychopathological symptoms.~     However, there are no studies showing how these interventions modify objective measures of~     stress. For example, measures reflecting Hipotalamic-Pituitary-Adrenal (HPA) axis activity,~     the main system involved in the stress response. The activity of HPA axis is also altered by~     illness and psychopathology. Hair cortisol technique allows for changes assessment of HPA~     axis activity during months. Therefore, hair cortisol may be considered as an useful tool to~     measure changes of emotional variables related to stress in the long term. This measure of~     change over time of HPA axis activation together with related emotional variables assessment~     could be useful to evaluate the efficacy of interventional programs. For this reason, the aim~     of this research is to assess the effects of a cognitive-behavioral treatment (CBT) on~     perceived stress, resilience, worries, psychopathology and HPA axis activity through hair~     cortisol analysis.~   "
6926|NCT03476187|"~     Subjects meeting the inclusion/exclusion criteria will wear the µCor for at least 90 days.~     During the study, clinic follow up will occur every 30 days. For all subjects, each scheduled~     clinic visit will include assessment of cardiac symptoms and any relevant clinically~     actionable events. The subject will be given a daily diary to track symptoms, unplanned~     hospital visits, medication changes, and all other heart failure related clinical events.~     Weekly phone calls to the subject will be given throughout the duration of the study to~     remind the patient to use the subject diary and to collect and record heart failure related~     clinical events. Subjects will be contacted six months and one year from initial enrollment~     to assess the vital status of the subject, any heart failure related clinical events since~     the end of µCor wear, and any health care utilization since the end of µCor wear.~   "
6927|NCT03476174|"~     The primary objective of this single arm phase 2 trial is to assess the response rate~     [complete response (CR) + partial response (PR)] of sequential therapy of pembrolizumab~     followed by HD IL-2 in subjects with stage IV malignant melanoma. Response assessment will be~     performed after pembrolizumab therapy, and response reassessment will be performed after HD~     IL-2 therapy using revised RECIST 1.1.~   "
6928|NCT03476161|"~     This study looks at two new types of orthodontic brackets (metal squares of the brace) that~     have recently been released. Both types have been developed to allow the brackets to stick~     better to the tooth surface. The difference between the two groups is the adhesive ('glue')~     that is used. One uses a more conventional type of pre-coated adhesive (APC-II). The other~     type uses a new flash-free adhesive that does not require the excess to be removed once~     placed. It is claimed by the manufacturer that this new adhesive has a far lower failure rate~     than other types. However, there are very few studies that have looked into the bond failures~     of these adhesives comparatively, with most being lab-based studies outside of the mouth.~      The purpose of this study is to investigate which of the two bracket types lasts longest when~     glued to teeth for brace treatment and if there are any particular reasons why they may fail.~     This in turn will provide good evidence and research for future use of different bracket~     types, with an aim to prevent brackets from coming loose as little as possible during~     treatment. This could potentially result in smoother treatment for the participants and fewer~     visits.~      A total of 56 participants within the Orthodontic Department at Guy's Hospital London, shall~     be recruited to the trial and randomly placed into one of the two groups. The participants~     invited to take part in the trial will require fixed braces ('train-tracks') and meet the~     specific criteria that the investigators are looking for. Once the braces are fitted, regular~     appointments are made and participants are asked to return for emergency appointments if any~     of the brace comes loose. The total time for follow-up after the brace is fitted is a maximum~     of 3 months. The results shall then be analysed.~   "
6929|NCT03476148|"~     Rehabilitation after total knee arthroplasty is very important in terms of range of motion of~     the knee, muscle power, normal gait, pain control and consequently the patient's~     satisfaction. Convectional rehabilitation methods in assist of therapist required high demand~     of resources. Recently, outpatient clinic or tele-communication tool based rehabilitations~     were investigated and reported equivalent results. However, those methods also required group~     or one-to-one facing that restricted availability of the exercise.~      With development of the motion tracking technology, new device that gives real time feedback~     with augmented reality images can be used for rehabilitation in home-based setting.~      This study aims to compare the clinical outcomes after the rehabilitation by interactive~     home-based device or conventional inpatient setting.~   "
6930|NCT03476135|"~     This is an open-label, multi-center study to describe the immune persistence of the priming~     dose and describe the immunogenicity and safety of a booster dose of MenACYW conjugate~     vaccine in children in Finland who had been vaccinated 3 years earlier as toddlers with~     either MenACYW conjugate vaccine or Nimenrix® as part of the MET54 study (NCT03205358).~      The objectives are:~        -  To describe the antibody persistence of meningococcal serogroups A, C, Y, and W before a~          booster dose in children who received either MenACYW conjugate vaccine or Nimenrix® 3~          years earlier as toddlers~        -  To describe the antibody responses to meningococcal serogroups A, C, Y, and W 30 days~          after a booster dose of MenACYW conjugate vaccine in children who received either~          MenACYW conjugate vaccine or Nimenrix® 3 years earlier as toddlers~        -  To describe the antibody responses against tetanus toxoid 30 days after a booster dose~          of MenACYW conjugate vaccine in children who received either MenACYW conjugate vaccine~          or Nimenrix® 3 years earlier as toddlers~        -  To describe the safety profile of a booster dose of MenACYW conjugate vaccine in~          children who received either MenACYW conjugate vaccine or Nimenrix® 3 years earlier as~          toddlers~   "
6942|NCT03475979|"~     Study Purpose:~      A multicenter prospective study to evaluate the outcome of second breast cancer surveillance~     with abbreviated breast MR (AB-MR) or ultrasound (US) in addition to annual mammography in~     women with BRCA1/2 mutation testing~      Study Scheme:~        -  AB-MR, US, and digital mammography will be performed on the same day and interpreted~          independently at baseline and then after 1 year.~        -  After completion of study, patients are followed-up for at least 1 year.~   "
7156|NCT03473184|"~     This Phase 1 study is designed to determine the photoirritation potential of CCP-020~     (Diacerein 1%) when application is followed by light exposure.~   "
6931|NCT03476122|"~     Colorectal cancer (CRC) is among the most preventable cancers when precancerous lesions are~     detected at an early stage. Current screening methods for CRC require bowel prep or~     stool-based testing that are inconvenient, resulting in low compliance. Stool based tests~     have limited sensitivity for the detection of precancerous lesions.~      The CMx platform has been showed to be able to the detection of Circulating Tumor Cells~     (CTCs) in high sensitivity and specificity. In published studies, circulating Tumor Cells~     (CTCs) are captured and quantified in advanced-stages of colorectal cancer. In order to~     detect early and pre-cancer circulating tumor cells, we have developed an Automated Liquid~     Biopsy Platform that improves the detection of CTCs in early cancer stages. Therefore, this~     study goals are: 1) to establish a standard detection process utilizing the Automated Liquid~     Biopsy Platform. 2) Parallel comparison of laboratory manual operation and Automated Liquid~     Biopsy Platform. 3) Verify the feasibility of use of an Automated Liquid Biopsy Platform in~     the clinical setting.~   "
6932|NCT03476109|"~     Pragmatic trial to define the magnitude and the predictive factors of the response to~     omalizumab and mepolizumab in adult patients with severe refractory asthma and eligible to~     both therapies.~   "
6933|NCT03476096|"~     Sublingual microcirculation change in pregnant women with or without high risk pregnancy~     factors during pregnancy and postpartum period.~   "
6934|NCT03476083|"~     Immunoprophylaxis with two hepatitis B vaccinations following the hepatitis B immune globulin~     (HBIg) and hepatitis B vaccine at birth is largely effective in protecting infants from~     hepatitis B virus (HBV) infection. However, hepatitis B infection due to immunoprophylaxis~     failure often occurs in approximately 10% of infants who are born to highly viremic mothers~     with HBeAg-positive. Maternal HBV DNA > 200,000 IU/mL is the major independent risk for~     mother-to-child transmission (MTCT). A recent randomized controlled trial has shown that~     Tenofovir Disoproxil Fumarate (TDF) use during the third trimester of pregnancy could safely~     reduce the rate of MTCT with few adverse effects when combined with the administration of the~     standard immunoprophylaxis to the infants. However, HBIg is expensive and not available in~     many developing countries, resulting approximately 30% of infant infection when they received~     only HBV vaccination. The present study aims to investigate if highly viremic mothers who are~     treated with TDF from the second trimester to delivery in combination of infant's standard~     series of HBV vaccinations (omission of HBIg) have a comparable MTCT rates, when compared to~     those of mothers who receive TDF at the third trimester in combination of infant's standard~     HBV vaccinations and a birth dose of HBIg.~   "
6935|NCT03476070|"~     This study aims to evaluate the prevalence, biological mechanism and survivorship impact of~     cognitive toxicity among adolescent and young adult (AYA) patients diagnosed with curable~     cancers. The hypothesis is that cognitive impairment is clinically significant among AYA~     cancer patients treated with chemotherapy and that there will be detectable structural and~     functional changes in the brain for this patient group.~   "
6936|NCT03476057|"~     Liquid biopsy has been widely used in the diagnosis and treatment of tumors, and cfDNA has~     always been a hot spot in clinical research. Previous studies have shown that cfDNA may be~     associated with postoperative recurrence of gastric cancer, but it is rarely reported whether~     cfDNA is associated with the survival of gastric cancer. The purpose of this study was to~     assess the relationship between cfDNA and survival in advanced gastric cancer~   "
6937|NCT03476044|"~     For more than 60 years, succinylcholine is still being administered as the selective relaxant~     for rapid sequence intubation by anesthesiologists in many countries. It has been shown to~     possess unique features such as low cost, fast-acting, short half-life, safe metabolites, and~     causing excellent muscle relaxation for intubation. However, it has many side effects as~     well.~      Postoperative myalgia (POM), with an incidence rate of about 41%-92%, is one of the most~     common side effects of this drug and can take several days to cause significant discomfort in~     patients. However, its effect is felt more in the throat, neck, shoulder, and abdominal~     muscles and is common among patients with outpatient surgery. Due to its unknown real context~     of pathogenesis and in an effort to reduce the incidence and severity of~     succinylcholine-induced myalgia, various medications including non-depolarizing muscle~     relaxants, benzodiazepines, magnesium sulfate, opioids, gabapentin, pregabalin and~     nonsteroidal anti-inflammatory drugs have been tested, with varying degrees of success.~      Free radicals are created as a consequence of ATP (adenosine triphosphate) production by the~     mitochondria. These by-products are generally reactive oxygen species (ROS) as well as~     reactive nitrogen species (RNS) that result from the cellular redox process. These species~     play a dual role as both toxic and beneficial compounds. The delicate balance between their~     two antagonistic effects is clearly an important aspect of life. At low or moderate levels,~     ROS and RNS exert beneficial effects on cellular responses and immune function. At high~     concentrations, they generate oxidative stress, a deleterious process that can damage all~     cell structures. Muscle injuries might lead to the production of free radicals and further~     cellular damage, triggered by lipid peroxidation and protein oxidation. Peroxidation of~     membrane lipids leads to loss of membrane fluidity and elasticity, impaired cellular~     functioning, and even cell rupture. The various direct products of lipid peroxidation, such~     as malondialdehyde (MDA), isoprostanes, and 4-hydroxynonenal are considered among the most~     important biomarkers of oxidative stress in tissues. Malondialdehyde is a reactive carbonyl~     compound and is both mutagenic and carcinogenic. It reacts with DNA to form DNA adducts that~     are believed to contribute significantly to cancers linked to lifestyle and dietary factors.~     Protein oxidation can cause fragmentation at amino acid residues, formation of~     protein-protein cross-linkages, and oxidation of the protein backbone which ultimately leads~     to loss of function. Damaged proteins affect intracellular pathways and are contributing~     factors to different disorders and diseases. Protein carbonyl (CO) groups are produced on~     protein side chains during oxidation. High levels of protein CO groups have been observed in~     rheumatoid arthritis, Alzheimer's disease, diabetes, sepsis and chronic renal failure.~      Selenium is a well-recognized antioxidant which act s as a cofactor of antioxidant enzymes.~     This essential element helps protect the body against free radicals causing damage to the~     cells. Substantial evidence suggests that free radical production leads to increased oxygen~     uptake over time. The indirect though significant impact of selenium supplements is to~     protect the cells against oxidative stress and free radical production. Nature-made selenium~     contains 200 mg of this element with a natural origin, high absorption capacity, and~     prolonged retention. Selenium exerts its antioxidant effects through glutathione peroxidase.~     Glutathione peroxidase is an enzyme containing four selenium-cofactors that catalyze the~     breakdown of hydrogen peroxide and organic hydroperoxides. There are at least four different~     glutathione peroxidase isozymes in animals. Glutathione peroxidase 1 is the most abundant and~     is a very efficient scavenger of hydrogen peroxide, while glutathione peroxidase 4 is most~     active with lipid hydroperoxides. The glutathione S-transferases show high activity with~     lipid peroxides. These enzymes are at particularly high levels in the liver and serve in~     detoxification metabolism.~   "
6938|NCT03476031|"~     Hepatitis c associated glomerulonephritis is an immune complex disease that occurs in 21% of~     patients who have HCV infection.~   "
6939|NCT03476018|"~     The objective of this clinical trial is to evaluate the change of the immunological parameter~     levels in FIGO stage IIIB cervical cancer subjects by administration of Z-100~   "
6940|NCT03476005|"~     Incorrect labelling of blood samples occurs at a rate of 1% in the general laboratories and~     6% in Blood Transfusion Laboratories. The most serious error 'Wrong Blood in Tube' (WBIT)~     occurs when blood is taken from the intended patient, but labelled with another patient's~     details. Consequences may include, misinterpretation of a patient's diagnosis or clinical~     status, incorrect referral or treatment of a patient, or in the worst case scenario,~     incorrect cross matching for blood of the wrong blood group, which may lead to catastrophic~     outcomes, including death.~      The root causes for these errors is failure to identify the patient correctly and failure to~     correctly label the blood tubes at the bedside. To date, despite significant initiatives, it~     has proved very difficult to eradicate or reduce the error rate. Our project involves a~     novel, technology enhanced learning approach using proficiency based progression in a~     prospective randomised controlled methodology to significantly reduce this error.~      This approach to learning is more efficient and effective than the traditional approach of~     repeated practice and is made possible with metric-based simulations. This project will~     reduce the incidence of adverse events and avoidable medical errors associated with sampling~     and labelling errors including WBITs. This will be achieved by training healthcare~     practitioners to a proficiency standard in venepuncture. Thereby minimising the failure of~     health care professionals to identify the patient correctly and failure to correctly label~     the blood tubes at the bedside.~      This project's impact will deliver reduced sampling and labelling errors -including WBITs by~     a factor of 40-69%. Reductions of this magnitude will have profound national and~     international implications on how these types of skills are acquired and quality assured.~     This would result in improved patient safety and savings of over €500,000 at Cork University~     Hospital and if applied nationally result in exchequer savings of millions of euro annually.~   "
6941|NCT03475992|"~     The trialed investigational medical imaging device is a low-power microwave breast imaging~     system for cancer screening purposes. It is an active device which uses non-ionizing~     radiation.~      Microwave imaging is an emerging imaging modality for the early detection of the breast~     cancer. The physical basis of microwave imaging is the dielectric contrast between healthy~     and cancerous breast tissues at microwave frequencies. Microwave imaging can potentially be~     used for monitoring neoadjuvant chemotherapy treatment, breast health monitoring, and for~     routine screening and diagnosis of the breast cancer at the early-stage. The non-invasive and~     the non-ionizing characteristics of microwaves should allow for frequent scans of the breast~     using microwave imaging, unlike X-ray mammography. In addition to safety, microwave imaging~     does not require uncomfortable breast compression and it is potentially a lower-cost~     modality.~      This is a first-in-human clinical test of the investigational device, which has been so far~     tested only with experimental phantoms modelling the human female breast.~      The clinical data that will be collected in the context of this study is intended to provide~     early safety information for the investigational medical imaging device. In addition, this~     exploratory data will guide the refinement of the device hardware and the imaging algorithm~     design, before decision to proceed (or not) with further clinical tests.~      Furthermore, this study will be used to guide sample size calculation for a subsequent study~     designed to evaluate efficacy should that appear warranted once this study is completed.~   "
6943|NCT03475966|"~     Major surgery is a stressful procedure; good recovery after surgery is important to patients~     and their doctors. Studies done at the McGill University Health Centre (MUHC) with cancer~     patients awaiting surgery have shown that exercise combined with simple diet recommendations~     (which may include a supplement) and relaxation techniques before surgery helped speed up the~     ability to resume walking after surgery.~      These results have made the investigators aware that exercise and good nutrition are as~     important before surgery as they are after surgery; while it is common practice to start~     strengthening the body after surgery (rehabilitation), there may be some advantage to begin~     this process before surgery (prehabilitation).~      The purpose of this study is to see if the following program, either before or after surgery,~     can help patients recover from liver, pancreas or bile duct surgery:~        1. Exercise that may help participants move and breath better,~        2. Nutrition advice and a supplement to make participants strong,~        3. Relaxation and anti-anxiety tips to help cope with the stress of upcoming surgery~      The investigators will see if following this program will have an effect on participants'~     ability to walk before and after surgery.~   "
6944|NCT03475953|"~     Assessment of the efficacy and safety of Regorafenib and Avelumab in four cohorts of patients~     with advanced or metastatic digestive solid tumors (four cohorts), once the Recommanded Phase~     II Dose (RP2D) has been determined (phase I trial).~   "
6945|NCT03475940|"~     Coagulopathy in cardiac surgery; a quaternary-care academic center experience~      Objectives:~      Primary:~      To determine incidence of coagulopathy after cardiac surgery in Thai people To determine~     incidence of resternotomy for stop bleeding, morbidity and mortality~      Secondary:~      To identify risk factors which associated with non-red cell transfusion and coagulopathy~      study decide: Retrospective chart review~   "
6946|NCT03475927|"~     Knowledge and awareness of radiation hazard in health-care personnel; A Quaternary-care~     academic center study Aim: To determine knowledge and concerning about radiation hazard in~     anesthetic personnel and surgeon~      study decide: questionnaire based study to ask concerning and knowledge about radiation~     hazard~   "
6947|NCT03475914|"~     The skin harbors a complex and dynamic microbiota constituted by numerous microorganisms that~     live in symbiosis with the host. The specific etiology of psoriasis is still not-well~     understood; nonetheless several studies highlighted that that the skin microbiota could have~     a pivotal role in the maintenance and/or progression of the disease, acting as microbial~     predictor of psoriasis however.~      The aim of the present study was to characterize the microbiota of cutaneous biopsies~     associated to guttate and vulgaris psoriasis, both considering lesion and healthy skin~     belonging to the same psoriatic subject.~   "
6948|NCT03475901|"~     The investigators propose a pilot study to examine the feasibility of utilizing immersive~     virtual reality to reduce procedural anxiety in children undergoing non-facial laceration~     repair in the Pediatric Emergency Department.~      The investigators hypothesize that virtual reality will be well-received by patients and~     their caregivers, and that the anxiety provoked by laceration repair will be mitigated by the~     immersive virtual reality experience.~   "
6949|NCT03475888|"~     A chronic total occlusion (CTO) is common in patients with coronary artery disease. CTO~     recanalization has been shown to improve survival in comparison to failed CTO recanalization.~     Whether this is related to ventricular arrhythmias (VA) is unknown. The purpose of this pilot~     study is to evaluate the incidence of VA after successful CTO recanalization, failed CTO~     recanalization and untreated CTO. Patients will be monitored using an insertable cardiac~     monitor.~   "
6950|NCT03475875|"~     This study is a randomized, 4-visit, double-masked, 2x3 bilateral crossover, dispensing~     trial. The study lenses will be worn as daily wear (DW) for a period of two weeks each with~     one of the study lenses being worn twice. Each study lens is expected to be worn at least~     five (5) days per week for at least six (6) hours per day worn. There will be no washout~     period between study lenses.~   "
6951|NCT03475862|"~     The study will evaluate the human abuse liability of PTI-821 (oxycodone extended-release~     capsules) when administered nasally compared to crushed oxycodone IR tablets and crushed~     OxyContin tablets, also administered nasally.~   "
6952|NCT03475849|"~     The purpose of this study is to determine whether the bile acid circulation is changed after~     gastric bypass surgery. Further, to account for how the changed anatomy of the gut influences~     how the bile acid and food is mixed in the gut and how this is associated with the changes in~     gut hormone release after the surgery.~      Our hypothesis is that bile acid reabsorption from the gut is increased as animal models~     suggest so and bile acid blood concentration increases after surgery.~   "
6953|NCT03475836|"~     This study investigates the cognitive and mood effects of mint essential oils in a group of~     healthy, human adults. The investigational product will also be tested in vitro to ensure a~     number of biological mechanisms.~   "
6954|NCT03475823|"~     Two doses (475 mg and 950 mg) of Sideritis Scardica (SS or 'mountain tea') are investigated~     for cognitive, mood, blood pressure and cerebral blood flow effects in a healthy group of~     50-70 yr olds, both acutely and following 28 days of consumption.~   "
6955|NCT03475810|"~     The aim of the study is to evaluate the efficacy of virtual reality glasses on anxiety of the~     patients who underwent operations under spinal anesthesia during peroperative period. Both~     control group and VR group will be carry out STAI- Traıt anxiety test before operation and~     trait test after operation. Patients will be perform spinal anesthesia after standard~     sedation administration. After block reach adequate level for operation patients in VR group~     will wear the glasses and started to watch a documentary about birds and a sedative music by~     the headset. Patients in Control group will take standard anesthesia care. Hemodynamic~     changes (systemic blood pressure, heart rate, respiration rate and pSPO2) will be record in~     both groups.~   "
6969|NCT03475628|"~     The purpose of this study is to evaluate the effects of daratumumab monotherapy on bone~     disease in patients with relapsed/refractory MM who have received at least 2 prior lines of~     therapy, including lenalidomide and a PI.~   "
6970|NCT03475615|"~     This study is designed to compare the efficacy of intraperitoneal paclitaxel in combination~     with SOX, with SOX alone in the first-line treatment of gastric cancer with malignant ascites~   "
7340|NCT03470766|"~     Multicentre, randomised, double-blinded, sham-controlled trial with parallel economic~     evaluation. Patients will be allocated 1:1 to activated 10kHz SCS plus usual care~     (intervention) or sham 10kHz SCS plus usual care (control) and followed up to 6 months.~   "
6956|NCT03475797|"~     Medically intractable pain caused by occipital neuralgia can be very difficult to control~     with traditional pain management. Peripheral nerve stimulation which is used in migraines and~     cluster headache can be an alternative for these patients with occipital neuralgias when~     medical treatment and traditional pain management have failed (drugs for neuropathic pain,~     infiltrations, psychobehavioral approaches and multidisciplinary approach in a pain center).~     Occipital nerve stimulation consists to put a lead subcutaneously in front of the occipital~     nerve and to connect the lead to a pulse generator. A retrospective study of 60 patients was~     conducted in Nantes University Hospital. The results were good with the Visual Analog Scale~     (VAS) decreased from 8.4 preoperatively to 2.85 postoperatively. The medical quantification~     scale (MQS) was reduced to about 50% (18 preoperatively versus 9.9 postoperatively).~     Stimulation was quiet stable over time with a mean follow-up of 24 months (range 6 to 72~     months). The aim of StimO is to confirm this result through a national controlled randomized~     multicenter study where occipital nerve stimulation will be compared to the optimal medical~     management.~   "
6957|NCT03475784|"~     Postdural puncture headache (PDPH) is a common complication after cesarean delivery (CD). The~     role of peri-operative fluid therapy in prophylaxis against PDPH is unclear. The aim of this~     work is to compare restrictive versus liberal fluid therapy in prophylaxis against PDPH after~     CD~   "
6958|NCT03475771|"~     Pelvic fracture are very often treated by surgery ; however there are a high level of~     thrombotic risk during the surgery (venous thrombo embolic events represent about 10% to 50%.~      The aim of our study is to report the number of these events and identify the risk factor~     associated to these events regarding Greenfield Risk Assessment Profile .~   "
6959|NCT03475758|"~     The use of adjuvant chemotherapy in younger women with early breast cancer (EBC) has~     substantially improved the long-term outcome. However, this benefit is associated with~     long-term toxic effects which are becoming more important as prognosis improves. These~     include premature menopause and infertility in young pre-menopausal women. The incidence of~     premature menopause depends on the type and intensity of chemotherapy and the patient's age.~     In women <35 years old, the long-term (3 years after diagnosis) incidence of amenorrhea is~     similar to women who have not received chemotherapy, at ∼ 10%, but this increases to 50% in~     women between 35 and 40 years old, and can be up to 85% in women >40 years. Premature ovarian~     failure has major consequences including sexual dysfunction and infertility, and the latter~     may be of great concern to younger patients with breast cancer and has a bearing in~     influencing treatment decisions in almost 30% of cases.~      Currently, there is no standard treatment for preventing chemotherapy-induced ovarian~     failure. Previous studies have suggested that temporary ovarian suppression with a~     gonadotropin-releasing hormone (GnRH) analogue may preserve ovarian function both in humans~     and animal models. Clinical data are conflicting. For example, a recent Italian multi-center~     phase III study Prevention of Menopause-Induced by Chemotherapy: A Study in Early Breast~     Cancer Patients-Gruppo Italiano Mamella 6 (PROMISE-GIM6) reported that the use of GnRH~     analogue, triptorelin during chemotherapy in pre-menopausal patients with EBC, reduced the~     occurrence of chemotherapy-induced early menopause with four pregnancies after a 26-month~     follow-up [one in the chemotherapy alone arm and three in the triptorelin with chemotherapy~     arm]. In contrast, another trial suggested that the use of goserelin concurrently with~     neoadjuvant chemotherapy did not significantly reduce incidence of amenorrhea 6 months after~     the end of chemotherapy compared with those receiving chemotherapy alone and only two~     pregnancies were recorded [one in each arm] with a follow-up of 2 years.~   "
6960|NCT03475745|"~     Combined analysis of functional and structural language network changes may be a good model~     for predicting language outcome.~   "
6961|NCT03475732|"~     Pharmacokinetics and disposition of XueBiJing compounds in patients with sepsis~   "
6962|NCT03475719|"~     A phase 1 clinical trail to evaluate the safety and pharmacokinetic characteristic after~     administration of fixed-dose combination or loose combination of HUG186 in healthy adult male~     or menopausal female volunteers~   "
6963|NCT03475706|"~     This is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group~     study designed to evaluate the efficacy, safety, and tolerability of solabegron immediate~     release low dose or high dose tablets, compared to matched placebo, administered twice daily~     for 12 weeks to adult female subjects with overactive bladder symptoms (frequency, urgency,~     and predominantly urgency incontinence) for at least 6 months.~   "
6964|NCT03475693|"~     The objective of this study is to evaluate the efficacy of magnesium in symptomatic reduction~     of mild traumatic brain injury in the adolescent population in the acute setting of injury.~   "
6965|NCT03475680|"~     This study aims to demonstrate that a preoperative combination of mechanical bowel~     preparation and oral antibiotics, before elective laparoscopic colon cancer surgery, is~     associated with a reduction of postoperative surgical site infection rate, as compared to~     mechanical bowel preparation alone, oral antibiotics alone, or no colonic preparation.~      Our Hypothesis is that a preoperative colonic preparation including a combination of~     mechanical bowel preparation and oral antibiotics before elective laparoscopic colon cancer~     surgery is associated with a reduced rate of 30-day postoperative surgical site infection, as~     compared to mechanical bowel preparation alone, oral antibiotics alone, or no colonic~     preparation.~   "
6966|NCT03475667|"~     Inaccurate monitoring of mean arterial pressure (MAP) could lead to improper treatment in the~     form of excessive fluid infusion or unnecessary vasopressor therapy; therefore, accurate~     hemodynamic monitoring is crucial in treatment of septic shock.~      In critically ill septic patients treated with vasoactive drugs, many studies reported that~     radial arterial pressure monitoring significantly underestimates central arterial pressure.~     Insertion of a femoral line allowed a substantial reduction of the infusion rate of~     vasoactive drugs in these patients. These findings might imply that femoral placement of~     arterial lines is the gold standard for invasive arterial blood pressure monitoring in shock~     patient.~      Our study aimed to determine the difference between radial (peripheral) and femoral (central)~     arterial pressures measured simultaneously in a group of critically ill patients receiving~     high dose noradrenaline therapy (≥ 0.1 mcg/kg/min).~   "
6967|NCT03475654|"~     The overarching goal for this prospective randomized controlled trial (PRCT) is to determine~     whether a virtual-environment, home-rehabilitation program improves functional outcomes for~     individuals after a burn injury. Specifically, this study will test the efficacy of a~     technology-assisted rehabilitation program against current standard of home therapy.~   "
6968|NCT03475641|"~     Varicose veins affect a majority of adult population in the western world. They decrease~     quality of life and may also cause venous ulcers. Therefore varicose vein treatments are~     justified. Currently endovenous thermal ablation is a treatment of choice for varicose veins.~     At the outpatient setting, however, treating both limbs at the same time may be painful to~     the patient especially, if simultaneous phlebectomies are performed.~      The study aims to evaluate, if femoral nerve blockade can significantly decrease pain during~     the procedure without prolonging the stay in the hospital.~   "
6971|NCT03475602|"~     Idiopathic membranous nephropathy (IMN) remains a common cause of the nephrotic syndrome in~     adults and one of the leading known causes of end-stage renal disease. Identification of~     circulating autoantigens provide potential biomarkers for diagnosis and therapy of idiopathic~     membranous nephropathy. M-type phospholipase A2 receptor (PLA2R) and Thrombospondin type-I~     domain-containing 7A (THSD7A) were identified as the target antigen in membranous nephropathy~     with high specificity and the concentration of serum anti-PLA2R antibody and anti-TSHD7A~     antibody were helpful for predicting disease activity. In our prospective cohort study,~     hospitalized patients diagnosed as IMN are prospectively studied. Circulating anti-PLA2R~     antibody and anti-THSD7A antibodies were recently screened by using enzyme-linked sorbent~     assay(ELISA). This study aims to analyse the difference of clinicopathological~     characteristics for different concentrations of serum anti PLA2R antibody and anti TSHD7A~     antibody, and analyze the association between baseline concentrations of serum antibody and~     disease activity. This study also explored the prediction effects of serum antibody~     concentrations with different types of therapeutic regimen in IMN and compare the curative~     effects of different types of therapeutic regimen in different serum antibody concentrations.~   "
6972|NCT03475589|"~     The tolerability of apatinib, an effective antiangiogenic agent, varies greatly in patients~     with stage IV cancer during treatment. This study will include patients with advanced (stage~     IV) gastric cancer, non-small-cell lung cancer (NSCLC), breast cancer or ovarian cancer, who~     will be administered apatinib treatment starting from 500 mg Qd and closely monitored for~     ADRs during the period of apatinib treatment. Meanwhile, relevant assay technologies will be~     used to precisely detect changes of various biomarkers in the patients treated by apatinib,~     with the aim of identifying biomarkers related to their prognosis and relevant complications~     so as to screen out the favored population, establish the drug's indication(s) and reduce~     relevant side effects.~   "
6973|NCT03475576|"~     An aging population means an increase of the oldest part of the population, resulting from a~     change in demographic behavior and an increasing lifespan. The social networks are changing~     and the health care costs are rising. We know informal care of older civilians becomes more~     and more complex. A formal framework with a good communication to support informal caregivers~     is therefore essential in order to provide good care for a dependent older civilian.~      Informal care is the support and assistance of a dependent person, outside the context of~     professional care or organized volunteering, but by one or more members from the immediate~     vicinity of the dependent1. The 'informal care group' is defined as follows: 'a group of two~     or more persons who together provide informal care to a dependent person, beyond the scope of~     professional care or organized volunteering, but as members of the immediate vicinity of the~     dependent'.~      In this group, the different members contribute to the care process in an equitable but~     non-proportional manner. The dynamics in an informal care group are obviously different from~     those in a family where one central informal caregiver is responsible for the care of the ill~     relative: behind each individual of the informal care group, there is also a partner and/or~     children who influence the care motivations and accountability.~      Sharing informal caregiving has important advantages. Firstly, individuals of the informal~     care group needs less time to fulfill specific caregiver tasks and have more time to cope~     with external stressors. Secondly, caregivers in group receive support from each other, which~     strengthens their self-efficacy. However, the involvement of more caregivers may also be a~     source of conflict.~      This project aims to meet the needs of informal care groups of older civilians. An adjusted~     support for older civilians (≥70 years) and their informal care group will be achieved. We~     will focus on their needs, aimed to decrease the caregiver burden and increase the well-being~     of both older civilian and caregivers. This goal will be achieved by a better care planning~     and attempts to improve communication between older civilian, informal and professional~     caregivers, which we found in previous research as difficult and an important obstacle in~     concretize individual tailored support of the older civilian and caregivers.~   "
6974|NCT03475563|"~     The BIOSS Lim C pharmacoactive Stent has characteristics of design that makes it very~     suitable for the treatment of bifurcational lesions . The objective of the study is providing~     deeper knowledge into the results of this stent in the treatment of bifurcational lesions.~   "
6975|NCT03475550|"~     This is a quality improvement health services study in the Division of Gastroenterology at~     Beth Israel Deaconess Medical Center (BIDMC).~   "
6976|NCT03475537|"~     test~   "
6977|NCT03475524|"~     Melasma is a chronic and relapsing acquired dyschromia due to an increased epidermal-melanin~     unit activity that affects sun-exposed areas mainly in women throughout the reproductive~     years. It is more common in women, accounting for 90% of all cases.The majority of patients~     are in third and fourth decades of their life. There are several risk factors that influence~     its appearance including genetic predisposition,exposure to heat and UV radiation, pregnancy,~     and exogenous hormones (such as oral contraceptives,thyroid hormones, and hormone replacement~     therapy). Other factors implicated are phototoxic drugs, anticonvulsant medications,and the~     use of certain cosmetics. Types of melasma are epidermal, dermal and mixed according to~     location of melanin.~   "
6978|NCT03475511|"~     In this study, high-resolution brain functional magnetic resonance imaging (MRI) was used to~     evaluate the differences in brain structure and brain function network between patients with~     different degrees of disturbance of cognition and healthy controls by means of cohort~     follow-up and control study. The changes of patients' The dynamic changes of learning, to~     explore its clinical value as an early diagnosis. Combined with neurobehavioral scales and~     high-resolution brain structure, functional magnetic resonance imaging data to assess the~     brain structure, functional characteristics and consciousness of patients with impaired~     consciousness, and initially establish awareness of patients with recovery of consciousness~     Predictable imaging signs. Twenty eligible controls, 20 VS patients, and 20 MCS patients will~     be considered for inclusion in the inclusion / exclusion criteria. Informed consent will be~     obtained as required before starting any registration process.~   "
6979|NCT03475498|"~     Chronic right ventricular pacing has a deleterious effect on left ventricular (LV) function,~     namely pacing-induced cardiomyopathy (PICM). Pacing site, pacing burden, pre-implant LV~     dysfunction and QRS duration make difference of effect on the occurrence of PICM and its~     subsequent clinical outcomes. In particular, recognition of a major determinant for~     occurrence of PICM may lead to better identification of patients at high risk. Investigators~     prospectively enroll a participant with documented high risk of PICM and clinically follow-up~     to idenify clinical impact of PICM (PICM syndrome) over a long period of time.~   "
6980|NCT03475485|"~     The ID-Cap System is classified as an ingestion event marker (IEM), a Class II medical~     device. The system is intended to record time-stamped ingestions with the ingestible sensor,~     ID-Tag which transmits a signal to a wearable device, the ID-Cap Reader. In this study, 36~     subjects will ingest capsules containing ingestible sensors while wearing the Reader and~     being observed in a clinic setting.~   "
6981|NCT03475472|"~     Investigators aim to directly investigate the molecular properties of bacteria from tracheal~     and urinary samples routinely taken in intensive care units (ICU) patients.~   "
6982|NCT03475459|"~     A study to assess the QTc prolongation effect of NPC-15 (melatonin 8mg or 16mg)~   "
6983|NCT03475446|"~     The aim of this study is to investigate the effect of a transcranial electrical stimulation~     (tES) on a cognitive training in healthy elderly and memory impaired participants. In order~     to assess these effects different memory and attention tasks will be performed before and~     after the training as well as after 6 and 12 months.~   "
6984|NCT03475433|"~     This study focuses on whether or not physical activity and sleep quality correlate with the~     health of prostate and breast cancer patients. The activity data will be acquired using~     wearable actigraphy devices, which the subjects will wear for the duration of seven days. The~     sleep quality will be measured using a combination of actigraphy and the mandarin version of~     the Pittsburgh Sleep Quality Index (PSQI) and the Quality of Life Questionnaire (QLQ). By~     using this combination, the investigators will not only measure the objective physical~     activity while the patient is asleep, but also the subjective sleep quality. The~     questionnaire will also function as control data for the accuracy of the actigraphy device.~      This study will recruit approximately 30 breast or prostate cancer patients. The participants~     will wear a wearable actigraphy device for 7 consecutive days, which will provide accurate~     and objective movement and sleep data. This data is linked to a unique Identification number~     (ID), which will be noted in the participant's case report. This case report also contains~     the participant's information and answers to the questionnaires.~   "
6985|NCT03475420|"~     There are 13.7 million Americans currently living with a history of cancer. With continued~     improvements in cancer treatment and increasing life expectancy, this number is expected to~     reach nearly 18 million within the next decade. The care of these cancer patients, including~     surveillance during the post-treatment survivorship phase, is an increasingly important major~     health care concern and expenditure. As the fourth leading diagnosis among cancer survivors,~     lung cancer is emerging as a chronic problem that currently affects over 450,000 Americans~     and is expected to grow by nearly 20% by 2022.~      Lung cancer is the second most common cancer in the United States. Of the estimated 182,550~     patients newly diagnosed with non-small cell lung cancer (NSCLC) this year, approximately 35%~     will present with localized disease and be eligible for curative resection. For patients with~     limited NSCLC, surgical resection is the most effective method of controlling the primary~     tumor and provides the best opportunity for cure. A recent analysis by this group~     demonstrated that the number of lung cancer resections has increased over the past decade,~     with over 45,000 lung cancer resections performed annually in the US.~      This research will address a critical gap in knowledge because the optimal approach to~     post-treatment surveillance following lung cancer resection is unknown. The intensity of~     recommended surveillance visits ranges from every 3 months during the first two years to an~     annual visit. Imaging modalities range from CT scans to chest radiographs to no routine~     imaging for asymptomatic patients. The reason for these significant differences is a lack of~     quality data on lung cancer surveillance and clinical guidelines based largely on small~     retrospective analyses and expert opinion.~      The National Cancer Data Base (NCDB) provides real world national lung cancer resection and~     surveillance data on over 70% of newly diagnosed lung cancers from more than 1,500~     institutions. This study will compare the effectiveness of the three most common surveillance~     intensities (CT scans every 3 months vs. 6 months vs. annually) on the stakeholder selected~     outcome of survival. All analyses will be risk adjusted for differences in patient~     characteristics at baseline, including tumor characteristics, patient age, comorbid disease,~     and other potential confounders. Analyses will also be adjusted for the competing risk of~     death.~   "
6986|NCT03475407|"~     Intravitreal Ozurdex implant therapy improves visual outcome and OCT findings. The purpose of~     this study is that these results are correlated with the change of cytokine level known to be~     increased in DME patients.~   "
6987|NCT03475394|"~     Background: Periodontitis is a chronic inflammatory disease of tooth and supporting tissues~     with clinical signs of bone and connective tissue loss and is mediated by a combination of~     periodontal pathogens and host defense systems. Currently the use of herbal products in~     dentistry is increasing due to their easy availability, low cost and lesser side effects. One~     such herbal plant is Morus alba which is known to possess medicinal properties. Therefore the~     present study was conducted to determine the clinical effectiveness of subgingivally~     delivered Morus alba gel incorporated into polaxamers vehicle for its controlled release on~     periodontal pocket in adjunct to scaling and root planing for treatment of moderate~     periodontitis patients.~      Methods: one hundred twenty patients with chronic periodontitis having PPD of 4-6 mm were~     treated by full-mouth scaling and root planning (SRP) and curettage. They were randomly~     assigned into one of the two groupswith 60 in each group: Group 1: Chlorhexidine Sol-gel was~     applied at baseline, 15 and 30 days. Group 2: Morus alba Sol-gel was applied at baseline, 15~     and 30 days. Plaque index (PI) (Silness and Loe), Gingival index (GI) (Loe and Silness),~     Community Periodontal index, Periodontal pocket depth and quantitative analysis (anaerobic~     culture) of Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis and Tannerella~     forsythia were assessed at baseline and after 45 days.~   "
6988|NCT03475381|"~     The purpose of the study is to examine the real-life safety and effectiveness of the novel~     combination ivacaftor+lumacaftor in eligible patients with cystic fibrosis (CF). All patients~     with CF were eligible if they were 12 years and older, started ivacaftor+lumacaftor outside~     of a clinical trial between December 15th 2017 and December 15th 2018 in an accredited CF~     center in France. Patient followed-up is based on standardized recommendation of the French~     Cystic Fibrosis Society. Each patient is followed 1 year.~   "
6989|NCT03475368|"~     It is widely known that the quality of the diet is able to modify the expression of many~     bacterial genes populating the intestine of the host, as well as the type of bacteria~     themselves. This is also expressed with a more or less evident and troublesome after meals~     symptomatology that many patients complain to the health care staff.~      A good composition of the microbiota is crucial for the health of the individual, both at the~     intestinal level as well as at the systemic level because, depending on the type of food~     substrate available at the intestinal level, metabolites will be produced capable of~     positively or negatively affect the health of the individual.~      In fact, scientific evidence shows the existence of the causal link between the health of the~     microbiota and the genesis of inflammatory diseases not only intestinal, but also systemic,~     and even of cancer, obesity, metabolic syndrome and atherosclerosis.~      The recent diffusion of gene sequencing techniques has brought significant developments in~     the study of the human and bacterial genome, which allow to produce enormous quantities of~     sequences at a lower cost and at a higher speed than previous techniques.~      Therefore the clinical Nutrition Clinic of the IRCCS De Bellis in Castellana Grotte (BA)~     proposes to check if changes in the intestinal microbiota correlate, not only with~     anthropometric and clinical-laboratory parameters, but also with the typical symptoms of~     irritable bowel syndrome (IBS), a functional pathology very widespread with the advent of the~     modern era, in which, a diet rich in sugars and proteins of animal origin and poor in plant~     foods, is unfortunately common also in the areas of the Mediterranean basin.~   "
7365|NCT03470441|"~     The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics (PK) of~     three dose levels of FDY-5301 compared to placebo in STEMI patients undergoing PCI.~   "
6990|NCT03475355|"~     The main objective of this project is to evaluate the effectiveness of Observation of Action~     (Action Observation, AO) both in increasing the speed of movement of the upper limbs, agility~     and locomotion, and in improving the activities and quality of life in people with~     Parkinson's disease (PD) during a 4-6 month follow-up. The second objective is to evaluate~     the feasibility and effectiveness of a tele-rehabilitation protocol using home-based AO~     therapy. The telecommunication technology will provide a complete training through a low-cost~     software run on a touch-screen device, which will show the actions to be imitated several~     times by people with PD. This project will be the first attempt to implement AO-based~     treatment at home and, if successful, will be highly translational to clinical practice~     thanks to the advanced development and broad accessibility of information technology and~     telecommunications in our country. Furthermore, continuous exercise will reduce the risks of~     complications and the frequency of hospital admissions, thus reducing costs for the National~     Health System.~   "
6991|NCT03475342|"~     Postpartum haemorrhage (PPH) is responsible for about 100,000 maternal deaths every year,~     almost all of which occur in low and middle income countries. When given within three hours~     of birth, tranexamic acid reduces deaths due to bleeding in women with PPH by almost one~     third. However, for many women, treatment of PPH is too late to prevent death and severe~     morbidities. Over one-third of pregnant women in the world are anaemic and many are severely~     anaemic. We now want to do the WOMAN-2 trial to see if giving tranexamic acid can prevent PPH~     and other severe outcomes in women with moderate and severe anaemia.~   "
6992|NCT03475329|"~     The aim of the study is to evaluate adenoidectomy with bilateral partial tonsillectomy~     compared with adenoidectomy with classical unilateral complete tonsillectomy for management~     of pediatric Obstructive Sleep-Disordered Breathing (OSDB) in terms of efficacy of the~     technique and reducing postoperative complications.~   "
6993|NCT03475316|"~     Dancing is a complex sensorimotor rhythmic activity that integrates cognitive, physical, and~     social components and is applicable to seniors with various fitness levels. Despite its~     popularity, there is a paucity of studies that have systematically examined the role of~     dancing in preventing or delaying cognitive decline in older adults at high risk for~     Alzheimer's disease and related dementias. This preliminary randomized clinical trial will~     help provide the evidence base to develop a definitive full-scale trial to support or refute~     prescription of social dancing to prevent further cognitive decline in older adults at high~     risk of Alzheimer's disease and related dementia.~   "
6994|NCT03475303|"~     This study will investigate the effect of early hospital discharge versus traditional one on~     maternal outcome for women undergoing elective cesarean sections.~      aim of the work is to assess rate of maternal hospital revisits after early hospital~     discharge at 8-12 hours following elective cesarean delivery compared to the current practice~     of discharge at 24-48 hours postoperatively.~   "
6995|NCT03475290|"~     The aim of this study is to assess the efficacy of internet intervention for reduction of~     occupational stress and its negative consequences (job burnout, depression) among medical~     professionals through the enhancement of the resources that are critical for coping with~     stress: self-efficacy and perceived social support.~   "
6996|NCT03475277|"~     This study is a biomarker study designed to characterize how ketamine impacts the reward~     circuits of the human brain.~   "
6997|NCT03475264|"~     The MRI tools developed by the investigators are well positioned for assessing regional~     changes in lung structure and function in preterm children with bronchopulmonary dysplasia~     (BPD), in which airway limitation similar to asthma, alveolar simplification similar to~     emphysema and pulmonary vascular stunting are expected. To the investigator's knowledge, the~     combination of ultra short echo time (UTE) proton, pulmonary vascular proton and~     hyperpolarized 129Xe MRI have not yet been explored in BPD, either clinically or~     preclinically. The investigators propose that a comprehensive MRI examination may be useful~     from a diagnostic perspective, MRI of preterm children without BPD may reveal changes which~     are otherwise clinically 'silent' yet still place children at risk for future chronic lung~     disease in later life.~   "
6998|NCT03475251|"~     This study will evaluate the safety, tolerability, pharmacokinetic profile and treatment~     effect of a new drug known as CS1003 in patients with advanced tumors.~   "
6999|NCT03475238|"~     Patients who are hospitalized in intensive care unit (ICU) require basic nursing care to~     improve patient hygiene, to promote comfort, to prevent pressure ulcer, and foot or hand's~     retractations.~      Those nursing cares require mobilization very frequently which expose critically ill patients~     to occurrence of serious adverse events (SAE) such as i) hemodynamic, neurologic, and~     respiratory variations ii) unplanned dislodgement (lines, drains, catheters, endotracheal~     tube..)~      Few study have evaluated relation between SAE occurence and several patient's, service's,~     health-care provider's caracteristics. We plan to analyse those factors to find some ways to~     prevent SAE occurence during nursing and hygiene cares.~   "
7000|NCT03475225|"~     Almost all patients with epilepsy living in the region of Paris have vitamin D deficiency,~     which is severe in 1/3 of the cases. The impact of this deficiency on epilepsy is unknown,~     despite the suggested benefits of vitamin D therapy including better seizure control and~     improvement of comorbidities (fatigue, anxiety, depression) in drug-resistant patients.~     Recommendations for vitamin D supplementation based on the serum level in the general~     population cannot be applied to patients with epilepsy due to interference of antiepileptic~     drugs in the vitamin D metabolism. Animal models, mechanisms of action studies and ecological~     information provide objective data for a direct antiepileptic effect of vitamin D. Human~     studies seem to confirm the antiepileptic effect of vitamin D but there are no controlled~     studies on large populations. The investigators aim to assess prospectively the effect of the~     treatment of vitamin D deficiency providing a high level of evidence. The investigators~     propose a multicentre placebo controlled randomized double-blind study, testing vitamin D~     supplementation against placebo in 400 drug-resistant patients to assess the short-term (3~     months) and long-term (1 year) benefits on epilepsy. The investigators hypothesize that the~     treatment of vitamin D deficiency will result in significant reduction of seizure frequency,~     and improvement of comorbid symptoms as well as quality of life. The impact on the care of~     patients is important because better epilepsy control allows reduction of the antiepileptic~     drugs and side effects. This again is a key for the recovery of social and professional~     activities, and reduction of costs related to the disease.~   "
7001|NCT03475212|"~     The purpose of this study is to evaluate whether virus-specific T cell lines (VSTs) are safe~     and can effectively control three viruses (EBV, CMV, and adenovirus) in patients who have had~     a stem cell transplant and also in patients that have a primary immunodeficiency disorder~     with no prior stem cell transplant.~   "
7002|NCT03475199|"~     FabLife is an interventional, prospective, multicentre, controlled study undertaken in~     metropolitan France.~      The main objective is to evaluate the effect of FabLife personalised program over a period of~     15 weeks on the improvement of spermatic DNA fragmentation in subfertile men compared to~     general dietary recommendations.~   "
7003|NCT03475186|"~     This study is to determine if an oral drug called Ramipril can lower the chance of memory~     loss in patients with glioblastoma getting chemoradiation. Patients will take Ramipril during~     chemoradiation and continue until 4 months post-treatment. Memory loss will be assessed using~     several neurocognitive tests throughout the duration of the study.~   "
7004|NCT03475173|"~     This study investigates a new technology to assess the structure and function inside the eye.~     Retinal imaging of subjects with inner and outer retinal defects to detect areas of abnormal~     structure and function compared to other visual function tests.~   "
7005|NCT03475160|"~     Two groups of unexplained recurrent spontaneous abortion, each included 65 participants.~     scheduled randomly into; the study group received Sildenafil Citrate and Placebo group. The~     intervention started from day 21-23 of the cycle preceding spontaneous pregnancy and~     continued till the 12th-week of gestation.~      The primary outcome measure was the difference in the live birth between both groups.~     Secondary outcome measures were the differences between both groups regard pulsatility index~     (PI) and resistance index (RI), a number of take-home babies, the reported side-effects of~     treatment and the pregnancy-related complications.~   "
7006|NCT03475147|"~     The purpose of this project is to validate a quick, easy-to-use and administer smartphone~     flicker fusion test. The app (called eyeFusion) can potentially be used to easily and quickly~     collect critical flicker fusion measurements on patients admitted with optic disorders as~     part of the clinical care process.~   "
7007|NCT03475134|"~     This is a single center, single arm phase I trial to test the feasibility and safety of~     Tumor- Infiltrating Lymphocyte-Adoptive Cell Therapy (TIL-ACT) followed by nivolumab rescue~     in advanced metastatic melanoma patients. The trial is based on lymphodepleting chemotherapy~     followed by ACT, utilizing ex vivo expanded TILs in combination with high dose interleukin-2~     (IL-2) (optional, depending on patient's tolerance), followed by nivolumab rescue (if~     indicated) for a maximum duration of 2 years.~   "
7008|NCT03475121|"~     This protocol provides guidelines for the management of non-metastatic unilateral~     retinoblastoma and introduces an innovative adjuvant therapy for higher risk patients based~     upon the results of the Grupo de America Latina de Oncologia Pediatrica (GALOP) I study.~     Conservative therapy will be not protocolized.~   "
7009|NCT03475108|"~     The primary aim of this randomized controlled trial is to determine if the integration of a~     Community Health Worker into the healthcare team is associated with an improvement in~     diabetes control in children with type 1 diabetes. The secondary objectives are to determine~     if utilization of Community Health Workers is also associated with reduced emergency~     department visits and hospitalizations, improved attendance at outpatient diabetes~     appointments, and improvements in psychosocial outcomes and diabetes control.~   "
7010|NCT03475095|"~     Lumbar disk herniation (LDH)is a prevalent health problem around the world. It can cause~     symptoms of low back pain, numbness or weakness.The understanding of low back pain in~     traditional Chinese medicine(TCM) theoryunbalanced bones and musclesthat is consistent with~     the description of modern medicine on LDH function pathology. Tuina is one of Diagnosis and~     treatment methods in TCM which has been used as a noninvasive treatment of LDH. However, the~     mechanism of Tuina therapy in LDH is still unclear.The purpose of this study is to establish~     a platform of the therapeutic effect and mechanical effect of LDH in the treatment of~     LDH，explore the characteristics of Tuina by the motor control in lumbar CNS,observe the~     patterns and regularities in the function of related brain regionin of patients with acute or~     chronic LDH and reveal the mechanism of Tuina of improving the control of lumbar spine CNS~     movement.~   "
7011|NCT03475082|"~     The purpose of this study is to determine if changing the frequency or intensity of~     transcutaneous electrical nerve stimulation (TENS) can reduce the development of tolerance to~     TENS treatment.~   "
7012|NCT03475069|"~     Type 2 Diabetes Mellitus (DM) is a widespread worldwide disease. Exercise therapy is an~     effective method but which exercise types are more effective is an important question.~      This study was designed to compare the effects of three different exercise programs on~     physical function and quality of life in Type 2 DM. Forty-two patients with Type 2 DM~     participated in the study. The patients were randomly assigned to three groups. Client based~     exercises in accordance with physiotherapy assessment were applied to group 1 (aged~     51.42±4.60 years; body mass index 35.28±4.21 kg/m² kg/m²), Clinical Plates exercises were~     applied to group 2 (aged 53.07 ±5.12 years; body mass index 35.56±4.83 kg/m²) and a standard~     program including calisthenics exercises were applied to group 3 for 12 weeks, 3 days a week.~     6 minutes walk test (6 MWT) and physiological cost index (PCI), timed up and go test (TUG)~     and SF-36 quality of life questionnaire were performed before and after the 12-week exercise~     program.~   "
7013|NCT03475056|"~     RV 507 is a Phase I, open-label study to examine safety, tolerability and immunogenicity of~     an investigational Marburg vaccine given by intramuscular (IM) injection to healthy adults.~     The study is a dose escalation of VRC-MARADC087-00-VP, a chimpanzee adenovirus serotype 3~     vector vaccine, which encodes wild type (WT) glycoprotein (GP) from Marburgvirus.~   "
7014|NCT03475043|"~     Millions of elderly adults in the USA have age related hearing loss (ARHL), a malady that~     affects half of adults 60-69 years, and the majority of older adults. This hearing loss not~     only impacts communication and functional ability, but also is strongly associated with~     cognitive decline and decreased quality of life. This project aims to develop effective~     strategies to compensate and reverse this process through a deeper understanding of~     plasticity and adaptive auditory function, and how to engage it and harness it to remedy~     ARHL.~   "
7366|NCT03470428|"~     This study aims to determine what are some of the clinical characteristics and associations~     of Fontan patients who are doing well, as well as how accurate cardiology providers are at~     predicting the likelihood of future adverse event in their Fontan patients.~   "
7015|NCT03475030|"~     Patients often have problems with their medications after leaving the hospital and going back~     home. The goals of this study are to provide a special electronic pill-box with pre-filled~     weekly medication trays that can alert patients when it is time to take their medications,~     alert family members (with patients' permission) if there is a problem, and produce a report~     of medication-taking habits for patients' primary care providers. The investigators will~     evaluate the effects of this technology on patients' ability to take their medications~     safely, on the control of chronic conditions like high blood pressure, and also ask patients~     about any barriers to using this technology in the real world. The investigators hypothesize~     that a smart pillbox (i) can be successfully implemented in the transitions setting,~     including engagement of patients, caregivers, and providers in electronically available~     medication adherence reports; (ii) will decrease medication discrepancies and increase~     medication adherence in the 6 months after hospital discharge; and (iii) among patients with~     hypertension, diabetes mellitus, and hyperlipidemia will improve routinely collected measures~     of disease control.~   "
7016|NCT03475017|"~     Many studies have been conducted to identify therapeutic strategies to modulate inflammation~     and oxidative stress, complications that contribute to the increased morbidity and~     cardiovascular mortality in patients with chronic kidney disease (CKD). Among several~     non-pharmacological strategies, the use of bioactive compounds has emerged as a potential~     approach to reduce these complications in CKD patients. In this context, turmeric/curcumin~     may have positive consequences in terms of cardiovascular and nephroprotection because of its~     antibacterial, antiviral, anti-inflammatory and anti-oxidative effects. The aim of this study~     is the role of curcumin as a nutritional strategy to reduce cardiovascular risk factors as~     inflammation and oxidative stress in CKD patients.~   "
7017|NCT03475004|"~     This is an open-label, single-center, single-arm phase II clinical trial evaluating the~     combination of pembrolizumab, binimetinib, and bevacizumab in patients with metastatic~     colorectal adenocarcinoma who have not responded to prior therapy.~   "
7018|NCT03474991|"~     The purpose of this study is to concurrently evaluate whether adjunct treatment with~     corticosteroids in children hospitalized with CAP is more effective in terms of the~     proportion of children reaching clinical stability and whether such adjunct treatment is no~     worse in terms of CAP relapse.~   "
7019|NCT03474978|"~     This study examines whether there is an association between the PICC insertion site and the~     complications necessitating PICC removal in neonates admitted to neonatal intensive care~     unit.~   "
7020|NCT03474965|"~     The purpose of the Phase 2 CSEG101B2201 study is to confirm and to establish appropriate~     dosing and to evaluate the safety in pediatric patients ages 6 months to <18 years with a~     history of VOC with or without HU/HC, receiving crizanlizumab for 2 years. The efficacy and~     safety of crizanlizumab was already demonstrated in adults with sickle cell disease. The~     approach is to extrapolate from the PK/pharmacodynamics (PD) already established in the adult~     population. The study is designed as a Phase II, multicenter, open-label study.~   "
7021|NCT03474952|"~     Remote ischemic preconditioning (RIPC) has been revealed organ-protective effect in many~     previous clinical settings including coronary intervention or cardiovascular surgery. However~     its protective role during free flap reconstructive surgery in head and neck cancer patients~     has not yet been elucidated. The purpose of the current study is to evaluate the effect of~     RIPC on tissue oxygen saturation and skin temperature of the flap, as well as its~     organ-protective effect using Langendorff isolated heart ischemia-reperfusion model.~   "
7022|NCT03474939|"~     The study aim is to assess whether premedication with midazolam prior to surgery affects~     copeptin concentration in blood.~   "
7023|NCT03474926|"~     Recent studies showed the therapeutic benefit of lymphadenectomy in advanced stage urothelial~     carcinoma of the upper urinary tract, but there is still a lack of prospective studies. Thus,~     the current guideline recommends lymph node dissection for invasive upper tract urothelial~     carcinoma (UTUC) on the basis of insufficient evidence. Also, the preoperative judgment of~     muscle invasive pathological stage T 2+,or N+ is difficult from preoperative imaging. In the~     investigators' clinical practice, the surgeons performed dissection of regional lymph nodes~     only in patients with enlargement of lymph nodes found in preoperative imaging or during~     surgery. The aim of this multi-institutional study was to examine the role of lymphadenectomy~     in urothelial carcinoma of the upper urinary tract.~   "
7024|NCT03474913|"~     This is a clinical trial to test the efficacy of an upright MRI for the screening of prostate~     cancer. The purpose of this study is to compare Upright MRI as a technique to PSA (Prostate~     Specific antigen) and current MRI imaging. The target population is men who are at risk for~     prostate cancer, as determined by the urologist. Patients will be asked to take the~     Indomitable Magnetic Resonance Imaging Scanner, magnetic resonance imaging using 0.6 T~     strength, as well as a standard of care closed 3T MRI. The patient will then be given a~     series of questionnaires to assess their comfort level during both MRI's.~   "
7025|NCT03474900|"~     There are disadvantages in Elastic Stable Intramedullary Nailing (ESIN) of forearm shaft~     fractures, such as soft tissue irritation and the need of implant removal. A new~     mini-invasive technique of intramedullary nailing with biodegradable material (BESIN) has~     been developed. The nails are tapped into the medullary cavity and left in place. The aim of~     this study was to compare BESIN technique with ESIN.~      This is a prospective, randomized, controlled clinical trial including the patients (aged~     5-15 years) who required operative treatment for forearm shaft fractures in two pediatric~     trauma centers, in Finland. The patients were randomized to be treated by BESIN or ESIN.~     Thirteen patients were required for each group, according to power analysis but altogether 35~     were enrolled for potential drop-outs. Biodegradable polylactide-co-glycolide (PLGA) nails~     (ActivaNail ®, Bioretec ltd, Finland) were used in 19 and titanium nails (TEN ®, Synthes ltd,~     USA) in 16 patients. Pain and the range of motion (ROM) of forearm, elbow and wrist were~     primary outcomes. Radiographs and potential complications were analyzed of all and magnetic~     resonance imagines (MRI) of a randomly selected subgroup in BESIN group (N=13).~   "
7072|NCT03474276|"~     The aim of this open-label randomized controlled trial conducted in four African countries~     (Madagascar, Niger, Central African Republic and Senegal) is to compare three strategies of~     renutrition for moderate acute malnutrition (MAM) in children based on modulation of the gut~     microbiota with enriched flours alone, enriched flours with prebiotics or enriched flours~     coupled with antibiotic treatment. Cognitive development of children (Senegal) will also be~     studied and compared.~   "
7026|NCT03474887|"~     BACKGROUND/SIGNIFICANCE: With developments in mobile health and the abundance of smartphones,~     online consultations have emerged as a popular form of primary care in Sweden. Controversy~     exists regarding diagnostic accuracy, appropriate prescription of antibiotics, and effects on~     care-seeking patient behavior following implementation of online consultations. As empirical~     research is lacking, the investigators seek to evaluate online primary care consultations~     compared to physical consultations with regards to non-inferiority of antibiotic prescription~     for chief complaint of sore throat.~      METHODS: Medical record data is used to identify patients with a chief complaint of sore~     throat, cough/common cold/influenza, or dysuria after choosing online (DIGI) or physical~     (PHYSI) consultations. A cohort of patients with similar chief complaints prior to~     implementation of online consultations was used as a control group (CONTROL). Prospective~     data from local registries and medical records was gathered 14 days the consultation. The~     primary outcome was rate of antibiotic prescription after sore throat. Secondary outcomes~     included patient revisits (including hospital admissions), patient satisfaction, time to~     physician contact, registered diagnosis, and documentation or Centor Criteria and Urinary~     Tract Infection (UTI)-Criteria.~      SIGNIFICANCE: Results will shed light on whether antibiotic prescription differs~     significantly between digital and physical primary care consultations. Hypotheses may also be~     generated as to how patients seek care in light of improved availability in a tax-sponsored~     healthcare system.~   "
7027|NCT03474861|"~     This is an open-label study to evaluate the safety and efficacy of an anticancer medication~     (A01) combined with immune cells (IC01) in subjects with advanced Gastrointestinal cancer.~   "
7028|NCT03474848|"~     Hand-Arm Bimanual Intensive Training (HABIT) has been shown to result in improvements in hand~     function and daily functioning of children with unilateral cerebral palsy (CP). Children with~     bilateral CP may also present difficulties to coordinate their hands to perform activities.~     Thus, HABIT may be a potential intervention for these individuals. We intend to examine the~     effects of HABIT on hand function and daily functioning of children with bilateral CP~     compared with conventional occupational therapy (OT). Our hypothesis is that children~     receiving HABIT will present larger improvements in manual dexterity and daily functioning as~     compared to conventional OT.~   "
7029|NCT03474835|"~     The purpose of the study: to increase the efficiency of diagnosis, treatment and prediction~     of the course of coronary heart disease in patients with adenocarcinoma of the prostate~     gland, depending on the hormonal status by determining the cardiovascular risk factors,~     factors of angiogenesis, structural and functional state of the heart, coronary vessels,~     kidney damage and their pharmacological correction.~   "
7030|NCT03474822|"~     The purpose of this study is to evaluate the safety and preliminarily evaluate the~     effectiveness of Plasmodium immunotherapy for advanced breast cancers and advanced liver~     cancers.The treatment will last 3-6 months from the day of successful infection and will be~     terminated by antimalarial drugs.~   "
7031|NCT03474809|"~     The main purpose of this study is to compare the early detection of sepsis and the decision,~     by the Investigator to start or not, or to change, antibiotics in Intensive Care Unit (ICU)~     patients at high risk of sepsis, based on standard of care (clinical, laboratory and imaging~     data but not on PSP values), as well as timing of antibiotic de-escalation versus the the~     retrospective assessment (i.e., at the end of the study) of a First Endpoint Adjudication~     Committee (EAC) which is aware of the clinical data and of the PSP values but not of the~     Investigator's decision(s), and of the retrospective assessment of a Second Endpoint~     Adjudication Committee which is only aware of the PSP values.~      This study will follow the site's routine clinical practice for the diagnostic, assessment~     and treatment of the enrolled patients, with the exception of daily blood samples which will~     be taken for the PSP measurement using the AbioScope as well as another daily sample taken~     for central analysis of biomarkers of inflammation, infection and/or sepsis (including but~     not limited to C-reactive protein [CRP] and Procalcitonin [PCT]).~   "
7032|NCT03474796|"~     The study aims to show a difference of observation and data integration between novice and~     expert during anaesthetic induction, in a population of nurse anesthetists.~   "
7033|NCT03474783|"~     Objectives:~      Promoting quitting smoking and training smoking cessation educators in hospital, school,~     community, and workplace was being vigorously pushed by Health Promotion Administration.~     Since the implementation of the second-generation smoking cessation program by Health~     Promotion Administration, both the general public and medical institutions have worked with~     greater vitality to practice and promote quitting smoking. However, studies on smoking~     cessation in the inpatient remain inadequate. Increasing cessation motivation for inpatient~     smokers and evaluating their nicotine dependence are essential. In this study, we aimed to~     explore the factors that might influence the smoking cessation in the inpatients.~      Method: A cross-sectional questionnaire survey was conducted on inpatients participants at~     the smoking cessation.~      Questionnaire comprising（1）Demographic characteristics: age, sex, marital status, education,~     （2）physiological factors（concentration of carbon monoxide, nicotine dependence, disease~     severity）,（3）psychological factors（psychological dependence on smoking , smoking cessation~     stages of behavior change, smoking cessation self-efficacy）, （4）Social Factor: social~     support,（5）smoking Behavior indicators: smoked, daily cigarette consumption, smoking~     experience. After giving health education cessation of treatment one month, three months and~     six months, interviewed by telephone quitting behavior index contains daily cigarette~     consumption, quit rates point.~   "
7034|NCT03474770|"~     The purpose of this study is to examine safety signals and demonstrate seizure reduction in~     adults with FIAS treated with BIS-001ER as an add-on therapy in an in-patient and out-patient~     study design.~   "
7035|NCT03474757|"~     This population-based descriptive study will characterize first-time users of three NOACs~     (rivaroxaban, dabigatran and apixaban) in prevention of stroke in non-valvular atrial~     fibrillation (SPAF) patients and will assess the patterns of drug utilization in routine~     general practice in Colombia~   "
7073|NCT03474263|"~     Patients with rapidly progressive ALS will be assigned to IC14 intravenously on Day 1-4. This~     4-day course will be repeated on Days 8-11. Patients will all undergo MR-PET scans at~     Massachusetts General Hospital at two time points: before treatment onset and after the last~     treatment cycle. This scan will measure areas of ALS disease activity and assess response to~     IC14 treatment. MR-PET scans will be compared to historical controls.~   "
7036|NCT03474744|"~     For marginal zone lymphoma (MZL) Rituximab in combination with conventional chemotherapy is~     widely used for those patients who fail local therapy or do not qualify for such. Depending~     on the MZL subtype Rituximab/chemotherapy is able to induce in part long remissions, but do~     not prevent relapse later on. In addition, chemotherapy associated toxicity is often~     problematic in MZL patients, who are mostly of advanced age. Thus, chemotherapy - free~     approaches are highly attractive for this patient group. Rituximab single agent is a widely~     used chemotherapy - free approach in MZL, but was significantly inferior compared to~     Rituximab/chlorambucil in a large randomized prospective clinical trial in treatment naïve~     MZL with a CR rate of 56 % vs. 80%, respectively (P<0.001). Thus, it is the major aim to~     develop chemotherapy - free approaches for MZL, which approach efficacy of~     Rituximab/chemotherapy combinations, but avoid chemotherapy associated toxicities. This in~     particular important in MZL as many physicians are reluctant to treat these often elderly~     patients with more intense treatments and prefer single agent therapies in these very often~     well and long responding lymphoma subtype. The PI3K inhibitor Copanlisib has shown high~     clinical activity in indolent B - cell lymphomas among them MZL. Based on these observations~     it is the aim of this study to test the toxicity and efficacy of Copanlisib in combination~     with the anti-CD20 antibody Rituximab in patients with newly diagnosed or relapsed MZL in~     need of treatment, who are not eligible or failed local therapy, following the assumption~     that this novel chemotherapy - free combination is significantly more effective than~     Rituximab single agent therapy and at least as efficient as Rituximab/chemotherapy, but~     avoids chemotherapy - related toxicity.~   "
7037|NCT03474731|"~     Background and justification: Nearly 29 million Americans (9.3% of the population) have type~     2 Diabetes Mellitus (T2DM) and another 86 million are considered prediabetic, 20-30% of whom~     will develop diabetes within five years.4,5 T2DM disproportionately affects those from lower~     socioeconomic status (SES) and rural backgrounds. Appalachian residents represent an extreme~     version of this already vulnerable population, with rates of diabetes 46% higher than~     national averages.6,7 The investigators have developed, pilot tested (N=41) and refined (N=48~     in-depth interviews, 4 focus groups with 31 participants, and 2 CAB meetings with 16~     members), a culturally appropriate, feasible, and promising intervention that combines~     diabetes self-management education and tailored patient navigation intervention., Goal: Our~     goal focuses on reducing HbA1c, BMI, blood pressure, lipids, and waist circumference and~     improving T2DM self-management and clinic attendance. Leveraging local assets, including~     faith communities, local health facilities, trained community health workers, and social~     support, the investigators will expand a promising and refined pilot study and assess~     outcomes, satisfaction and cost effectiveness. Innovation and impact: The proposed project is~     among the first RCT to combine the two most influential approaches to diabetes control--~     self-management education and tailored patient navigation in a community setting. The~     Community to Clinic Navigation (CCN) intervention has the potential to sustainably empower~     hard to reach populations with effective self-management education and enhance the quality of~     healthcare in traditionally underserved communities, greatly improving T2DM outcomes.~   "
7038|NCT03474718|"~     The study team will assess the efficacy of platelet-rich plasma therapy, a special blood~     product which is from the participant's own body, in the treatment of androgenic alopecia~     (also known as male pattern hair loss) in females.~   "
7039|NCT03474705|"~     Objectives: The aims are to 1) evaluate the clinical impact of eccentric training in female~     computer users with chronic NSP, 2) compare pressure hyperalgesia, temporal summation of pain~     (TSP), and conditioned pain modulation (CPM) in female office workers with and without NSP,~     and 3) assess changes in central pain responses after training.~      Methods: In part A, twenty office workers with NSP will be compared with 20 healthy controls.~     In part B, the NSP group will undergo a 5-week eccentric training program. Participants will~     report their pain intensity, and complete the Neck Disability Index, and the Disabilities of~     the Arm, Shoulder and Hand questionnaire. Pressure pain thresholds (PPTs) will be assessed~     over the neck and forearm. Cuff algometry will identify pain detection (PDT) and tolerance~     thresholds (PTT). TSP will be evaluated by visual analogue scale pain scores during 10~     repetitive cuff stimulations. CPM will be calculated as the difference in PDT with and~     without a conditioning painful stimulus. Outcomes will be measured at baseline and~     post-intervention.~   "
7040|NCT03474692|"~     The purpose of this registry is to establish a research data repository, comprised primarily~     of data generated in the course of clinical care, to conduct research on Virta Health~     clinical interventions and the chronic diseases suffered by Virta Health patients. This~     single-center repository that makes use of all clinical data generated through the provision~     of clinical services by Virta Health for its patients. Additional research-only patient~     follow-up information will also be collected via questionnaire.~   "
7041|NCT03474679|"~     The purpose of this study is to evaluate efficacy of ibrutinib in Japanese participants with~     steroid dependent/refractory chronic graft versus host disease (cGVHD) by measuring overall~     cGVHD response (complete response [CR] and partial response [PR] defined by National~     Institutes of Health [NIH] consensus development project criteria [2014]).~   "
7049|NCT03474575|"~     The prevalence of chronic obstructive pulmonary disease (COPD) is between 8 and 15% of the~     adult population in 2010. This prevalence is expected to increase over the coming decades due~     to the aging of the population and the continued exposure to risk factors for the disease.~     The evolution of COPD is marked by the occurrence of exacerbations of variable severity~     responsible for 1% of emergency admission. 95% of COPD patients admitted to emergency~     department are hospitalized.~      Several recent studies seem to show that an early discharge from hospital with home care can~     reduce the rate of re-hospitalization and mortality of COPD patients. These preliminary data~     on low numbers need to be confirmed. In addition, it seems necessary to identify the~     phenotypes of patients benefiting most from these early exits.~      Exadom project (supported by Rhône-Alpes-Auvergne Regional Health Authorities (ARS),~     AstraZeneca and Grenoble Alpes University Hospital) aims to establish a safe and effective~     way of discharging patients by providing enhanced home-based care for AECOPD.~   "
7050|NCT03474562|"~     This study will evaluate the effect of high-dose rosuvastatin combined with telmisartan or~     amlodipine on glucose metabolism in ASCVD patients with impaired fasting glucose and~     hypertension.~   "
7074|NCT03474250|"~     Kidney Magnetic Resonance assessment before and after undergoing transcatheter aortic valve~     replacement~   "
7042|NCT03474666|"~     Context: The hyperglycemia is an important independent risk factor for the Surgical Site~     Infection (SSI) development among liver transplantation recipients. Objective: To evaluate~     the effects of an intensive postoperative protocol of blood glucose management on the~     surgical site infection incidence among liver transplantation recipients. Material and~     methods: It is an open-label clinical trial that will be randomized into 2 groups of blood~     glucose (BG) control: patients will undergo BG control regular in the facility chosen to~     research development (BG targeted 130-180 mg/dL) and the second one will undergo intensive BG~     control (BG targeted 80 - 130 mg/dL) until patients are eating at least 50% of a full liquid~     diet or receiving bolus tube feedings. A computer program will be employed to generate the~     randomized schedule that will be put into sequentially numbered opaque sealed envelopes by an~     external expert to research. A finger prick device will be used to measure the blood glucose.~     A blinded adjudication committee to analyse the primary endpoint SSI will adopt the SSI~     criteria given by the Centers for Disease Control and Prevention. The research proposal will~     be registered on ClinicalTrials.gov database. Central tendency and dispersion measures,~     Pearson's χ2 test, Fisher's Exact Test, Mann-Whitney, Wilcoxon-Mann-Whitney and survival~     analysis by Kaplan-Meier estimated and Log-rank test will be used for data analyses. Expected~     outcomes: The results of the study should contribute to establishing better clinical~     practices on glycemic control in the liver transplantation recipient's postoperative period~     aiming to reduce SSI incidence and its associated morbidity and mortality.~   "
7043|NCT03474653|"~     Latitude is an observational study exploring how effective Bulkamid ® is as a first line~     treatment for women with stress urinary incontinence. Women who choose to have Bulkamid as~     part of their standard clinical care will be asked to complete questionnaires before and~     after their surgery so that we can assess how their urinary symptoms change.~      As a second part of the study, we are asking all patients having any first line treatment for~     stress incontinence to complete a short questionnaire telling us how they decided what~     treatment to have. A small number of these women will be contacted via telephone and asked~     whether they would mind being interviewed to tell us more about this.~      We will also interview a number of doctors taking part in Latitude to find out how they~     counsel patients about different treatment options for stress urinary incontinence.~   "
7044|NCT03474640|"~     The primary objective is to assess the safety and tolerability of TAB001 in subjects with~     various advanced malignancies and to evaluate the recommended Phase 2 dose.~      The secondary objectives are to: 1) describe the pharmacokinetic (PK) profile of TAB001, 2)~     evaluate antitumor activity of TAB001; 3) determine the immunogenicity of TAB001 , and 4)~     evaluate pharmacodynamic effects of TAB001 on its target receptor, programmed cell death 1~     (PD-1), as well as effects on the immune system.~      The exploratory objectives are to: 1) evaluate biomarkers that may correlate with activity of~     TAB001, 2) evaluate the utility of PD-L1 & additional exploratory markers as biomarkers that~     could aid in selection of appropriate subjects for TAB001 therapy, and 3) identification of~     additional biomarkers correlating with response to treatment with TAB001.~   "
7045|NCT03474627|"~     The study aims to investigate the radiological and histomorphometric results of the use of~     PLGA-coated biphasic calcium phosphate granules in sinus floor elevation, to analyze the~     underlying molecular processes by immunohistochemical staining, and to evaluate the handling~     of the biomaterial and the in situ hardening properties.~      A randomized clinical study is designed to include patients in need of two-stage sinus floor~     elevation. Patients are assigned to receive either PLGA-coated biphasic calcium phosphate~     particles (group I) or the equivalent but non-coated particles (group II). CBCT scans are~     performed before and 6 months after the procedure to assess the bone height gain. At the time~     of implant placement, bone core biopsies are obtained at the site of implant placement.~     Histological sections are subjected to histomorphometric and immunohistochemical evaluation~     of differentiation markers.~   "
7046|NCT03474614|"~     This is a single center, randomized, trial that will enroll twenty (n=20) patients with a~     diagnosis of symptomatic cavernous malformations who are planned candidates for surgical~     resection by one of the investigators, and who meet all of the inclusion and exclusion~     criteria. Patients will be randomized into two groups: A Treatment group of ten (n=10)~     patients that will receive oral propranolol at a dose of 60mg per day (one 60mg ER capsule~     per day) for 7- to 10-days prior to surgery plus their usual medications, and a Control group~     of 10 (n=10) patients will receive only their routine medications. Currently, the only active~     treatment alternative for symptomatic cerebral cavernous malformations is surgery.~      A control group is required to allow for a semi-quantitative comparison with mRNA and miRNA~     levels in the treatment group.~   "
7047|NCT03474601|"~     The purpose of this study is to investigate the treatment and natural history of pituitary~     disease. We have a longstanding interest in pituitary disease including acromegaly, central~     diabetes insipidus, and nonfunctioning pituitary adenoma. We will continue to follow patients~     and recruit new patients for treatment and follow-up. Blood and pituitary tumor tissue (when~     available through clinical care) will be saved for future analyses related to pituitary~     disease.~   "
7048|NCT03474588|"~     Specific aims are as follows:~        -  To adapt our existing CBT4CBT program for use with Spanish-speaking alcohol users in a~          web-based platform~        -  To conduct an 8-week randomized trial evaluating the feasibility and efficacy of adding~          CBT4CBT-Spanish to treatment as usual in a community based treatment program in a~          population of 90 Spanish-speaking individuals who meet current criteria for alcohol use~          disorder~        -  To evaluate the long-term durability and/or delayed emergence of treatment effects~          through a six month follow-up after termination of the study treatments. Given previous~          evidence regarding the durability of standard clinician-delivered CBT and~          computer-assisted CBT4CBT, we hypothesize that CBT4CBTSpanish will be significantly more~          effective than standard treatment alone through the follow-up.~   "
7062|NCT03474406|"~     -Background: Cancer is one of the most common cause of death. Cancer pain is often cited as~     one of the most feared in cancer patients. Although, WHO guidelines have been provided to~     improve pain outcome, the results are still unsatisfied. In order to improve cancer pain~     management we consider to contribute a new guideline which includes interdisciplinary~     approach, early doing the pain interventions, breakthrough pain, education, high quality of~     pain assessment and contribute the effectiveness follow-up system~   "
7051|NCT03474549|"~     Tigertriever is a CE marked mechanical revascularization device indicated to restore blood~     flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic~     stroke within 8 hours of symptom onset. Patients who are ineligible for IV t-PA or who fail~     IV t-PA therapy are candidates for treatment.~      The objective of the TIGER Study is to evaluate the safety and effectiveness of the~     Tigertriever device in restoring blood flow in the neurovasculature by removing thrombus in~     patients experiencing ischemic stroke due to a large vessel occlusion (LVO). This study is~     designed to support substantial equivalence to approved and marketed products such as the~     Solitaire or Trevo Retriever.~   "
7052|NCT03474536|"~     The aim is to compare the quantitative parameters of de novo anti-HLA DQ Donor Specific~     Antibodies (DSA), determined at the time of their discovery by surface plasmon resonance~     (SPR), between recipients that developed a Chronic Lung Allograft Dysfunction (CLAD) for the~     2 years following DSA apparition and those who did not. If concentration, kinetics and/or~     affinity parameters of anti-DQ DSA are associated with CLAD development, new, non-invasive~     prognostic biomarkers of humoral rejection in lung transplantation will be discovered .~   "
7053|NCT03474523|"~     The aim of the present study is to value the effectiveness of Diathermy-Radiofrecuency~     treatment compared to Cavitation treatment in woman with cellulitis.~   "
7054|NCT03474510|"~     The purpose of this study is to examine the effectiveness of post-operative pain control of~     local infiltration (LIA) of EXPAREL administration to ropivacaine administered via continuous~     interscalene nerve block (CINB) for postoperative pain relief following shoulder replacement.~     Effectiveness will be measured in opioid consumption and NRS pain intensity scores from 0-4h,~     4-8h, 9-12h, 13-16h, 17-20, 21-24h, 48 hours and 72 hours post-op. Patient satisfaction with~     pain control; patient functional outcome; adverse events related to CINB, EXPAREL~     administration, and opioid consumption; and pain intensity scores from the time of surgery~     until post-operative day 10 (+/- 5 days) will also be examined.~   "
7055|NCT03474497|"~     This is a phase I/II study that will evaluate the safety and toxicity of this combinatorial~     approach. Eligible patients >18 years of age with histologically proven metastatic NSCLC,~     melanoma, RCC, or HNSCC who have failed PD-1 / PD-L1 checkpoint blockade therapy will be~     enrolled. Patients must have a candidate treatment lesion (subcutaneous, nodal, or visceral)~     accessible and safe for radiotherapy and serial intralesional injections as specified by the~     protocol. They must also have at least one target lesion (distinct from treatment lesion and~     outside of treatment lesion radiation field) evaluable for response by RECIST.~      This study will consist of a phase I dose escalation using a standard 3+3 design to determine~     safety and MTD of intralesional IL-2 which will be dose escalated in conjunction with~     standard fixed doses of RT and Pembrolizumab. At the MTD there will be a phase II dose~     expansion which will incorporate a simon-two stage design to assess efficacy and safety.~      Patients will receive pembrolizumab and intralesional IL-2 in combination with~     hypofractionated radiotherapy.~   "
7056|NCT03474484|"~     Lower respiratory tract infection is the most common cause of acute exacerbations of chronic~     obstructive pulmonary disease (AECOPD). Patients diagnosed with pneumonia in addition to an~     AECOPD experience more severe clinical and laboratory disease manifestations, increase~     in-hospital morbidity and worse outcome. Clinicians have sought for new biomarkers that~     together with clinical assessments can improve the diagnostic accuracy of pneumonia in~     patients with AECOPD.The aim of the present study is to compare the accuracy of calprotectin~     with procalcitonin (PCT), C-reactive protein (CRP) and white blood cell count (WBC).~   "
7057|NCT03474471|"~     Rationale: The published clinical trials investigating the bronchoscopic lung volume~     reduction, showing important patient-related improvements in efficacy, led to the~     acknowledgement of the treatment in the GOLD-COPD2017 guidelines. Interaction with pulmonary~     rehabilitation, impact on patient-reported outcomes, physical activity, and extrapulmonary~     consequences are all topics to gain more insight in. This importantly, to further develop and~     optimize this innovative and personalized therapy.~      Objective: To study in detail the impact and optimal timing of pulmonary rehabilitation (PR)~     on exercise physiology and patient-reported outcomes and the impact of the bronchoscopic lung~     volume reduction treatment using endobronchial valves (EBV) on cardiopulmonary function,~     metabolism and changes in body composition.~      Study design: This study is a randomized controlled trial with 3 study-arms. Group 1 will~     first follow a PR program and afterwards undergo the EBV treatment. Group 2 will first~     undergo the EBV treatment and approximately 8 weeks later will follow a PR program. Group 3~     will only undergo the EBV treatment (and can choose to follow a PR program after completing~     the 6 month FU visit).~      Study population: The study population exist of patients with severe emphysema who undergo a~     bronchoscopic lung volume reduction treatment using one-way valves.~      Intervention: Most patients will undergo a bronchoscopic lung volume reduction treatment~     using endobronchial valves and a pulmonary rehabilitation program. One group of patient will~     under a bronchoscopic lung volume reduction treatment using endobronchial valves and can~     choose whether they also want to follow a pulmonary rehabilitation program afterwards.~      Main study parameters: The main study parameter is the difference in change in endurance time~     measured by an endurance cycle test between the EBV treatment group and the bronchoscopic~     lung volume reduction + rehabilitation group (EBV+PR).~   "
7058|NCT03474458|"~     Systemic amyloidoses are rare diseases affecting approximately 1 in 100,000 persons each~     year.~      In systemic amyloidoses abnormal proteins deposit in bodily organs and severely impair their~     function, causing death if not treated effectively. Light chain (AL) amyloidosis is caused by~     a usually small population of plasma cells (the cells that produce antibodies). These cells~     produce part of antibodies, the light chains (LC) that form amyloid deposits. Almost every~     organ, with the exception of the brain, can be affected by AL amyloidosis. The heart is~     involved in three fourths of patients and is responsible for almost all the deaths occurring~     in the first 6 months after diagnosis. Current therapy of AL amyloidosis is based on drugs~     targeting the plasma cells producing the amyloid-forming LC. At present, most patients~     receive a powerful anti-plasma cell drug, bortezomib, as part of their initial treatment.~     However, bortezomib-based therapy, can improve heart involvement only in less than one third~     of patients with AL amyloidosis, and many patients (approximately one third) still die within~     12 months from diagnosis. Early cardiac deaths remain an acute unmet need and the major~     determinant of overall outcome in this disease. Thus, there is the need of alternative means~     to treat heart involvement in AL amyloidosis. Doxycycline is a widely used, well tolerated,~     antibiotic that has been marketed for decades and used to treat a number of different~     infectious diseases caused by bacteria. This molecule has been extensively studied in the~     laboratory, in animal models and, more recently, in small studies involving patients, for its~     potential of improving cardiac damage in amyloidosis. These studies showed that doxycycline~     disrupts amyloid deposits, reduces the amyloid load in a mouse model, and counteracts the~     toxicity exerted by amyloid-forming LCs on C. elegans, a worm whose pharynx is used as a~     model resembling human heart. In a small clinical study, doxycycline was given to patients~     with cardiac AL amyloidosis during treatment for their underlying plasma cell disease. This~     resulted in a remarkable improvement of survival compared to matched historical controls~     (i.e. similar patients who had received only anti-plasma cell therapy without doxycycline in~     the past). Based on these promising preliminary results, we designed the present clinical~     trial to assess whether the addition of doxycycline to anti-plasma cell therapy can improve~     survival in patients with cardiac AL amyloidosis who were not previously treated. The rate of~     survival at 12 months will be compared in patients receiving doxycycline and in controls~     receiving standard antibiotic therapy, together with anti-plasma cell therapy. Patients will~     be assessed for parameters of plasma cell disease, heart involvement and possible involvement~     of other organs, as well as for quality of life. To make sure that patients who will receive~     doxycycline and those who will not have comparable severity of cardiac disease, patients will~     be stratified according to the stage of cardiac involvement. Patients with very advanced~     heart dysfunction will not be enrolled in the trial, because preliminary data indicate that~     doxycycline is of little or no benefit in these subjects. Patients will be randomized to~     receive doxycycline or standard antibiotics in combination with anti-plasma cell therapy.~     Bortezomib-based treatment directed against plasma cells will be delivered according to each~     participating institutions' guidelines. Doxycycline will be administered at a dosage of 100~     mg two times a day, which is usual in the treatment of bacterial diseases. Standard~     antibiotics will be delivered according to each participating institutions' guidelines~     (provided that drugs of the same class as doxycycline are not administered) in the control~     arm. Patients will be provided a diary to record possible adverse events and will be~     instructed accordingly. Patients will be evaluated at trial centers every 2 months for~     treatment efficacy and toxicity. In case of unsatisfactory response second-line therapy will~     be initiated. In the absence of unacceptable toxicity, doxycycline administration will be~     continued for the entire duration of follow-up (12 months).~   "
7059|NCT03474445|"~     We plan to compare 2 types of plating systems for volar plating of distal radius fractures~     (Aptus 2.5® Medartis AG, Basel, Switzerland vs. INTEOS 2.5® - Hofer Medical GmbH and Co KG,~     Austria) in a prospective single-blinded controlled clinical trial.~   "
7060|NCT03474432|"~     BACKGROUD:~      Percutaneous coronary intervention (PCI) is increasingly used to treat unprotected left main~     coronary artery stenosis. Protected LM PCI is considered standard of care in most centers.~      OCT allows for precise determination of stent placement, stent expansion and apposition. The~     pattern of vessel healing can be very precisely studied if immediate post-stent implantation~     OCT/IVUS data is compared to the 6-month post-PCI interval.~      While OCT cannot be optimally used for ostial lesion imaging, IVUS can be used to image~     ostial lesions/stent placement.~      Optimal and consistent vessel healing is particularly important in LM PCI where stent~     thrombosis is a potential complication with serious adverse outcome.~      HYPOTHESIS:~      Due to the absorption of the polymer of the Boston Scientific Synergy Stent over time, early~     strut coverage patterns and timeline may be different than previously observed in DES and BMS~     stents in LM PCI. Late acquired stent malapposition (LASM) is expected to differ from~     previous observations with traditional DES/BMS.~      Stent coverage in LM PCI will be studied with OCT or IVUS at six and 12 months and compared~     to OCT or IVUS at the time of stent implantation.~      OCT/IVUS data will be analyzed in a core lab (CRF) and correlated with clinical outcomes at 6~     and 12 months.~   "
7061|NCT03474419|"~     Every year more than 70 000 interventions for prostatic adenoma are realized. Several type of~     surgery are realized going of the ambulatory to longer hospital lengths of stay. There are~     also several techniques.However it appears that ambulatory surgery is less costly. The~     arguments of surgeons are patients reluctance or the difficulty to manage in case of~     complication.~      The aim of the study is to show that there is a good acceptance from patient with a good~     level of satisfaction at day 30.~   "
7063|NCT03474393|"~     This study aims to analyse if intensive systematic treatment via internet and telephone~     during 4 months improved HbA1c for persons with type 1 diabetes which are already treated~     with CGM or FGM, and if the effect continuous for 1-2 years after the intervention stops.~     Time in Hypoglycaemia, treatment satisfaction, Diabetes distress and hypoglycaemia fear will~     even be analysed.~      A randomised, non-blinded, multi-centre, clinical study for persons with type 1 diabetes and~     hbA1c ≥ 58mmol/mol and treated with CGM or FGM.~      The control group continuous its normal diabetes care with study visits at randomisation, 10,~     18, 32, and 52 weeks for HbA1c and to fill in questionnaires.~      The intervention group will have contact with the study team on a weekly basis, when mean~     blood glucose levels the previous week are elevated. They will receive help with analysing~     data and advice on how to improve their glucose values. They will even meet the study team at~     randomisation, 10, 18, 32, and 52 weeks for HbA1c and to fill in questionnaires.~   "
7064|NCT03474380|"~     Optimizing Function and Independence Through iHI-FIVES aims to implement the iHI-FIVES~     caregiver skills training program at 8 VAMC sites in a stepped- wedge design and evaluate~     caregiver and patient outcomes before and after the program is implemented, as well as the~     efficacy of a usual vs enhanced implementation design.~   "
7065|NCT03474367|"~     Despite evidence of worse outcomes, initiation of renal replacement therapy by unplanned~     modalities in chronic kidney disease (CKD) patients is the reality in the practice for both~     hemodialysis and peritoneal dialysis. Unplanned therapy peritoneal dialysis (PD) is the~     initiation of the modality in less than 48 hours after implantation of the peritoneal~     catheter, without family training or adequacy of the home. Unplanned hemodialysis (HD) is the~     initiation of the method without a functional arteriovenous fistula, i.e., with a central~     venous catheter (nontunneled or tunneled).~      Growing evidence shows unplanned PD (or urgent start PD) as a viable and safe alternative to~     unplanned HD, with the similar rates of infection and survival.~      On planned scenario, solid studies demonstrate that PD has a better cost-effectiveness when~     compared to HD, however the literature lacks in this kind of analysis in unplanned methods.~      Briefly, the workgroup will follow patients that would anyway start a Renal Replacement~     Therapy by an unplanned method and register Government payment for the therapy, including the~     therapy direct costs and the costs with events (internation, infection), access for dialysis,~     laboratory and CKD specific medications to performed a cost-effectiveness analysis in both~     groups (Unplanned Hemodialysis and Unplanned Peritoneal Dialysis).~      The workgroup is responsible for the placement of the catheters (PD and HD) using the~     Seldinger Technique.~      The study is unicentric, the therapy is continuous and necessary for the maintenance of life;~     therefore, no great difficult in the follow up is expected. A database with up-to-date~     information of patients will be functional during the study.~      A Markov model will be developed to assess the relative cost-effectiveness of different~     dialysis modality distribution scenarios versus current practice. The model considers a~     hypothetical adult incident patient cohort with end-stage renal disease (ESRD) requiring~     dialysis and adopts payer perspective. Markov models have been used to model dialysis~     treatment in previous economic analyses and are widely accepted to be suitable for modelling~     chronic condition~      Statistical analysis plan:~      From the study protocol, the data will be entered in a spreadsheet and verified typographical~     errors and their analysis will be performed using the statistical program Statistical~     Analysis System (SAS) for Windows (version 9.2: SAS Institute, Cary, North Carolina, USA,~     2012).~      Considering an alpha error of 0.05 and a beta error of 0.2, power of statistic test of 0.8~     and cost difference detection between groups of 15%, the calculated sample size for each~     group is 94 patients.~      Initially descriptive analysis will be done for all patients treated in the period,~     calculated measures of central tendency and dispersion for continuous variables and~     frequencies for categorical variables.~      For the analysis of repeated measures, asymmetric distribution (gamma) under the Generalized~     Linear Model (GENMOD) procedure will be used.~      Chi Square will be used to compare categorical variable between the two groups. T test or~     Mann-Whitney will be used to compare parametric continue variables.~      By the utilization of Kaplan Meyer and log rank, survival curves of the two groups will be~     presented at the end of the study. A p-value of 5% or lower will be considered to be~     statistically significant~   "
7066|NCT03474354|"~     The primary purpose of the study is to evaluate the distribution of radiopaque microspheres~     loaded with doxorubicin in the treatment of unresectable HCC. Prospective, single arm, open~     label, single centre, pilot study. All patients will undergo clinical follow-up. Twenty~     patients will be enrolled.~   "
7067|NCT03474341|"~     Rationale: For locally advanced esophageal cancer the standard treatment consists of 5 weeks~     of neoadjuvant chemoradiotherapy (nCRT) followed by surgery.1 Surgery is currently performed~     independent of the response to nCRT and is associated with substantial morbidity. Prior~     knowledge of the eventual response to nCRT would greatly impact on the optimal care for many~     esophageal cancer patients for two imperative reasons:~      Firstly, it is argued that patients who achieved a pathologic complete response (pCR, 28-34%)~     may not have benefitted from surgery. Consequently, proper identification of pathological~     complete responders prior to surgery could yield an organ-preserving regimen avoiding~     unnecessary toxicity.~      Secondly, non-responders are exposed to the side effects of nCRT without showing any tumor~     regression. Early identification of the non-responders during nCRT would be beneficial for~     this group as ineffective therapy could be stopped, and for who altered treatment strategies~     could be explored.~      Objective: To develop a model that predicts the probability of pathologic complete response~     to nCRT in esophageal cancer, by integrating diffusion weighted magnetic resonance imaging~     (DW-MRI) and dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) in conjunction~     with combined 18F-fluorodeoxyglucose positron emission tomography and computed tomography~     (18F-FDG PET-CT) scans acquired prior to, during and after administration of nCRT.~      Study design: Multi-center observational study~      Study population: Patients (>18 years) with potentially resectable locally advanced squamous~     cell- or adenocarcinoma of the esophagus or gastroesophageal junction, receiving nCRT prior~     to surgery.~      Intervention: In addition to the standard diagnostic work-up for esophageal cancer that~     includes a 18F-FDG PET-CT scan at diagnosis and after nCRT, one 18F-FDG PET-CT scans will be~     performed during nCRT, as well as three MRI scans (before, during and after nCRT) within~     fixed time intervals. Furthermore, after response imaging after nCRT has been performed, but~     prior to surgery, patients will undergo (on an opt-out basis) an endoscopy and/or endoscopic~     ultrasonography (EUS) with biopsies of the primary tumor site, other suspected lesions and~     suspected lymph nodes. Furthermore, blood samples will be collected at five time points.~      Main study parameters/endpoints: An accurate prediction model for the patients' individual~     probability of pathologic complete response after nCRT, based on the quantitative parameters~     derived from a longitudinal series of DW-MRI, DCE-MRI and 18F-FDG PET-CT datasets.~   "
7068|NCT03474328|"~     Alcohol contributes to over 5% of deaths worldwide, and death rates from alcohol-related~     liver disease (ARLD) in the UK continue to rise sharply. On-going alcohol use in ARLD leads~     to markedly increased mortality (Thursz et al, 2015), and maintaining abstinence is a key~     therapeutic goal. However, there are no effective pharmacological therapies for maintaining~     abstinence. Brief intervention (BI) is an effective psychological tool for reducing alcohol~     use, but is difficult to scale widely.~      AlcoChange is a smartphone app and breathalyser (AlcoChange), which facilitates~     self-monitoring and delivers BIs in response to patient triggers. The aim of this open-label~     study is provide AlcoChange to 60 patients with ARLD, to determine compliance with the~     app/breathalyser and changes in self-reported alcohol consumption.~      Recruitment of inpatients/outpatients with ARLD and recent alcohol use will take place at~     Royal Free London. The inclusion criteria are: intent to maintain abstinence, possession of~     compatible smartphone. The exclusion criteria are: inability to provide consent. Participants~     will be assessed at baseline and 3-months. The primary endpoint is self-reported alcohol use~     (units/week, timeline follow-back). Secondary endpoint is compliance with the app (monitored~     remotely).~   "
7069|NCT03474315|"~     Patients with chronic heart failure (CHF) and reduced left ventricle ejection fraction~     benefit from cardiac resynchronization therapy (CRT) and implantable cardioverter~     defibrillator (ICD). Currently used devices, besides delivering low and high-energy~     therapies, record patient's activity and many hemodynamic parameters. However, increasing~     numbers of patient with CRT and ICD devices produce overload of cardiology centers where~     patients are admitted to ambulatory visits. Contrarily, there are technological possibilities~     for remote monitoring proven to be effective in recognizing damage of the implanted device~     and risk of exacerbation of chronic heart failure. Patients' registries show that majority of~     ambulatory visits are unproductive and do not result in significant modification of device's~     parameters. Promising experiences with application of data mining and machine learning~     techniques allow us to assume probable benefits from using modern methods of data analysis in~     determination of requirement for ambulatory follow-up on basis of data gathered through~     telemonitoring and clinical assessment of a patient.~      Aim of the study is to find multivariate model predicting the requirement for ambulatory~     follow-up of IECD.~   "
7070|NCT03474302|"~     The study is designed to develop and evaluate a physical activity promotion program among~     elderly African Americans with a long-term goal of reducing risk of Alzheimer's disease. The~     motivation for this study is that previous exercise interventions have improved cognitive~     function in older adults with and without cognitive impairments, but these studies were~     largely conducted without substantial African American representation. Due to genetic and~     environmental differences between African American and other populations, it is unclear~     whether positive findings from previous interventions will translate to African American~     individuals. We hypothesize that a community-based physical activity intervention will a) be~     tailored to African American adults, b) increase daily amounts of physical activity, and c)~     improve cognitive function in sedentary older African American adults.~   "
7071|NCT03474289|"~     The purpose of this study is to access the safety and tolerability of the study drug known as~     SHR-1316 in metastatic/advanced malignancies~   "
43867|NCT02992626|"~     In a randomised controlled cross-over study, the influence of interacting with a dog on~     children's learning performance is investigated.~   "
7077|NCT03474211|"~     Background: Currently prevalence of HPV infections for high risk strains among young women in~     Switzerland is unknown. In addition, since 2008 a vaccination program to prevent these~     infections has been implemented in a number of cantons, but its actual population impact is~     currently unknown. For now, HPV screening in Switzerland is mainly performed by gynecologists~     or during gynecological consultation at hospital. This method is certainly effective, but~     expensive; population coverage of screening is still insufficient. A whole segment of the~     target population does not participate in this screening especially young people of foreign~     origin, for various reasons: economic cost, no gynecological, and for other reasons.~      Several studies raise the effectiveness and efficiency of self-sampling to increase coverage~     of screening, and the rate of participation of non-participants. Through this study, the~     investigators evaluate effectiveness of this vaccination on the prevalence of HPV infections~     using HPV prevalence kit and assess evolution of infection and clearance of HPV virus during~     5 years in a population of young unvaccinated and vaccinated women.~      Method: During the study, each participants will perform a vaginal swab sampling by auto to~     research HPV. These samples will be sent to a laboratory where HPV typing is done by PCR~     using the Anyplex ™ II technology.~      The study will focus on a sample of 400 young women. Participants must complete a~     questionnaire containing demographic questions and their HPV immunization status. Vaccination~     coverage expected in this population is about 50%. Depending on the state of vaccination, two~     different groups will be vaccinated vs unvaccinated (200 women per group). The cases of HPV~     infection are then calculated for each group and compared as a function of the status of~     vaccination. Statistical tests will be applied McNemar's test for comparison between the HPV~     prevalence rates between the 2 groups.~      Expected Results: This study will allow us to confirm the possibility of using self-sampling~     as a method of screening and monitoring of HPV infections in the general population, it will~     also enable us to document the effectiveness of HPV vaccination by comparing prevalence rate~     of HPV infections among a group of young girls vaccinated and not vaccine and assess~     evolution of infection and clearance of HPV virus.~   "
7078|NCT03474198|"~     The current standard management strategy for drug-sensitive pulmonary tuberculosis (TB) is to~     treat with multiple drugs for 6 months, although patients often fail to adhere to the long~     treatment, leading to poor clinical outcomes including drug resistance, which is expensive~     and difficult to treat.~      The TRUNCATE-TB trial evaluates an alternative strategy (the TRUNCATE-TB Management Strategy)~     comprising treatment for 2 months (8 weeks, extended to 12 weeks if inadequate clinical~     response) with a regimen predicted to have enhanced sterilising activity (boosted regimen)~     and monitoring closely after treatment cessation. Those who relapse (predicted to be always~     drug sensitive and likely to occur early) will be retreated with a standard 6 month regimen.~      The trial is a randomized, open-label, multi-arm, multi-stage (MAMS) trial to test the~     hypothesis that the TRUNCATE-TB Management Strategy is non-inferior to the standard~     management strategy in terms of longer-term outcomes (clinical status at 96 weeks). If~     non-inferiority is demonstrated then the advantages/disadvantages of implementing the~     strategy will be explored in secondary outcomes (from patient and programme perspective).~      The trial will evaluate the TRUNCATE-TB Management Strategy with 4 potential boosted regimens~     (180 per arm, total 900 with the standard TB management strategy arm). The boosted regimens~     include new drugs (licensed drugs, repurposed from other indications) and optimized doses of~     standard drugs, selected based on consideration of maximal sterilising effect, absence of~     drug-drug interactions, as well as safety and tolerability over a period of 2 months~   "
7079|NCT03474185|"~     Background:~      Exercise-based cardiac rehabilitation (CR) is the gold-standard in tertiary prevention of~     coronary artery disease (CAD), yet average CR attendance is only 67%. Patient education is~     commonly delivered during CR to impart information about CAD and its risk factors. An~     underlying assumption is that knowledge will enhance patients' attitudes toward CR, promote~     better program adherence, and improve clinically relevant cardiovascular outcomes. However,~     more formative work is needed to characterize the impact of patient education delivered in a~     CR setting on purported mechanisms-of-action in order to optimize efficacy. Few cardiac~     patient education interventions have been empirically validated, and it is unclear whether~     knowledge gains from education translate to improved CR attitudes and program adherence.~      Objective: This study aims to 1) examine the association between cardiac patient education~     and changes in knowledge about CAD, and; 2) explore whether changes in knowledge correspond~     to (a) improved attitudes about CR (perceived necessity, concerns about exercise, practical~     barriers, perceived personal suitability), and (b) increased CR adherence.~      Hypothesis: It is expected that 1) knowledge will increase from pre- to post-patient~     education, and 2) knowledge gains will be associated with improved CR attitudes and better CR~     adherence.~      Methods: 100 adults with CAD referred to outpatient CR will be recruited prior to attending~     four, mandatory 2.5-hour-long group-based education classes. Patients will subsequently~     attend supervised CR exercise sessions twice-weekly for 12 weeks. Validated questionnaires~     assessing knowledge about CAD and attitudes toward CR (i.e., perceived necessity, exercise~     concerns, barriers, perceived suitability) will be completed pre- and post-cardiac education~     classes, and 12-weeks post-CR. Adherence (# of CR exercise sessions attended) will be~     obtained by chart review.~      Implications: This study will help identify whether patient education delivered in a CR~     setting impacts hypothesized treatment targets and inform future efforts to optimize~     behavioral interventions for increasing CR utilization~   "
7080|NCT03474172|"~     This study aims to evaluate the effectiveness of a Cloak Shape sham Pediatric Tuina device~     which can be applied in randomized controlled trials for Pediatric Tuina research.~   "
7081|NCT03474159|"~     The objective is the development and validation of morphological markers informative of~     aortic dilatation in order to improve the precision of the risk of aneurysm of the thoracic~     aorta and of acute aortic syndrome for patients with bicuspid aortic valve (BAV).~      The primary objective of this study is to demonstrate a correlation between the aortic local~     pulse wave velocity (PWV) measured with MRI and the progression of the thoracic aorta~     diameters measured by MRI after a follow-up of 2 years.~   "
7082|NCT03474146|"~     Chlorhexidine is considered as gold standard for its antiplaque and antigingivitis efficacy~     till date but it has got many side effects. So it is need of the hour that investigators will~     find some substitute having similar antiplque and antigingivitis efficay but have less or no~     adverse effects. so in this study investigators planned to do Comparative evaluation of~     antiplaque and antigingivitis efficacy of ocimum sanctum (tulsi) extract mouthrinse with~     0.12% chlorhexidine mouthrinse.~   "
7083|NCT03474133|"~     This study evaluate possibility of brentuximab vedotin, administered after first treatment~     failure (no response or relapse after I line therapy) of Hodgkin's lymphoma, to induce~     durable response or cure without autologous stem cell transplantation.~   "
7084|NCT03474120|"~     genetic screening and etiological analysis was conducted on patients with ovarian~     insufficiency and decline in ovarian reserve. All patients were enrolled in the IVF-treated~     and non-IVF-treated groups, followed up for long-term treatment outcomes and genomic~     screening.~   "
7085|NCT03474107|"~     The purpose of this study is to compare the overall survival (OS) of participants with~     locally advanced or metastatic urothelial cancer treated with enfortumab vedotin (EV) to the~     OS of participants treated with chemotherapy.~      This study will also compare progression-free survival on study therapy (PFS1); the overall~     response rate (ORR) and the disease control rate (DCR) per Response Evaluation Criteria in~     Solid Tumors (RECIST) V1.1 of participants treated with EV to participants treated with~     chemotherapy.~      In addition, this study will evaluate the duration of response (DOR) per RECIST V1.1 of EV~     and chemotherapy and assess the safety and tolerability of EV, as well as, the quality of~     life (QOL) and Patient Reported Outcomes (PRO) parameters.~   "
10417|NCT03430453|"~     The purpose of the study is define the minimal intensity of stimulation range at which the~     needle is closed to the nerve without penetrating its surface (epineurium layer) in~     ultrasound guided peripheral nerve blockade~   "
7086|NCT03474094|"~     This multicentric, randomised, Phase II trial will use a pick-the-winner design in order to~     evaluate the clinical and biological activity of atezolizumab when combined with~     pre-operative or post-operative radiotherapy in STS patients.~      Following Inform Consent Form (ICF) signature, eligible patients will be randomised (1:1:1)~     to receive:~        -  Arm A: Radiotherapy followed by atezolizumab then surgery.~        -  Arm B: Atezolizumab followed by surgery then radiotherapy.~        -  Arm C: Radiotherapy then surgery followed by atezolizumab.~      The sequence of the study treatments is different among the 3 study arms. However, the dose~     regimens will be the same:~        -  Atezolizumab will be administered to all patients at the dose of 1200mg, by IV~          injection, for 2 cycles (Q3W).~        -  Radiotherapy will be administered to all patients at the dose of 2Gy/day, 5 days per~          week, for a total of 5 weeks and 50Gy.~        -  Surgery will be performed as per institutional practice.~      Randomisation will be stratified according to histological subtypes as follows:~      Group 1: Liposarcoma (LPS), Undifferentiated Pleomorphic Sarcoma (UPS), Leiomyosarcoma (LMS),~     myxofibrosarcoma, angiosarcoma versus Group 2: all translocation sarcoma except Ewing,~     rhabdomyosarcoma (RMS) and myxoid LPS.~   "
7087|NCT03474081|"~     COPD is a progressive disease characterized by increasing obstruction to airflow and the~     progressive development of respiratory symptoms including chronic cough, increased sputum~     production, dyspnea and wheezing. Once-daily triple therapy of an Inhaled Corticosteroid/~     Long-acting Muscarinic Receptor Antagonists/ Long Acting Beta-Agonist (ICS/LAMA/LABA) that is~     combination of FF/UMEC/VI in a single device is being developed with the aim of providing a~     new treatment option for the management of advanced COPD. The primary purpose of this study~     is to evaluate lung function and health related quality of life (HRQoL) after 84 days of~     treatment with a single inhaler triple therapy combination of FF/ UMEC/VI once daily via the~     ELLIPTA® dry powder inhaler (DPI) compared with tiotropium once daily via HANDIHALER®, in~     subjects with COPD. Subjects will be randomized 1:1 to receive FF/UMEC/VI or tiotropium in~     the morning for 84 days. Subjects will also receive albuterol/salbutamol as a rescue therapy~     throughout the study. Approximately 848 subjects with advanced COPD will be enrolled in the~     study. The total study duration will be approximately 17 weeks including, 4-week run-in~     period, 12-week treatment period and a 1-week follow-up period. ELLIPTA is a registered~     trademark of GlaxoSmithKline (GSK) group of companies. HANDIHALER and RESPIMAT are registered~     trademarks of Boeringher Ingelheim.~   "
7088|NCT03474068|"~     Back pain is experienced by approximately 80% of the population during their life. However,~     only a small minority (<1%) will have a medical condition (such as Cauda Equina Syndrome)~     which requires immediate medical intervention.~      Currently, it is not known how many people access Emergency Medical Services (EMS) in an~     attempt to meet their needs for their back pain. The demand on EMS is increasing and many of~     these patients could be better managed by other services. Additionally, little is known about~     the characteristics of those accessing EMS due to back pain, or the nature of the contacts~     regarding issues such as outcome of the patient contact. The aims of this study are:~        1. to quantify the prevalence of people contacting EMS via telephone with non-traumatic~          back pain~        2. to describe the characteristics of people calling EMS with non-traumatic back pain~        3. to describe key characteristics of the contact between the service user and EMS~        4. to compare the call prevalence, patient characteristics and contact characteristics~          between people with non-traumatic back pain and a group of people for whom EMS contact~          is recommended as standard, in this case people presenting with cerebrovascular accident~          (CVA).~      A secondary aim of the work is to explore what factors might predict patient outcomes such as~     whether the patient is transported to A/E, whether the patient receives analgesics, and~     whether the patient is admitted to hospital.~   "
7089|NCT03474055|"~     This study has been designed to compare the liquid formulation of BRV-PV (LBRV-PV) with the~     lyophilized formulation (ROTASIIL) by testing the vaccine in infants (three doses~     administered 4 weeks apart, starting at 6-8 weeks of age) in order to demonstrate the~     non-inferiority in the induction of specific anti-rotavirus IgA antibodies by these vaccines.~     The study will also evaluate lot-to-lot consistency in the manufacture of LBRV-PV by~     demonstrating equivalence in the induction of specific anti-rotavirus IgA antibodies across~     three production lots.~   "
7090|NCT03474042|"~     This is a Phase IIa, multi-center, randomized, double-blind, placebo-controlled,~     parallel-group study to evaluate GLPG2737 administered orally b.i.d. for 28 days to adult~     male and female subjects with a confirmed diagnosis of cystic fibrosis homozygous for the~     F508del CFTR mutation and on stable treatment with Orkambi.~   "
7091|NCT03474029|"~     This study is conducted to compare the safety and effectiveness of a novel short 6-week~     regimen of daily rifapentine (6wP, experimental arm) with a comparator arm of 12-16 weeks of~     rifamycin-based treatment (standard of care, control arm) of latent M. tuberculosis infection~     (LTBI).~      This trial is conducted among persons who are at increased risk of progression to~     tuberculosis (TB) and require treatment of LTBI. The study will be conducted in the United~     States, the United Kingdom, and other countries with low to moderate TB incidence (< 100 TB~     cases per 100,000 population) that have treatment of LTBI as their standard of care and offer~     12-16 week rifamycin-based therapy as standard of care.~      The hypothesis of this study is that the safety and effectiveness of the experimental~     treatment (6wP arm) is non-inferior to a comparator arm of 12-16 weeks of rifamycin-based~     treatment of LTBI (control arm).~      Participants are enrolled and randomly assigned to one of the two study arms: experimental~     6wP or control. The comparator (control) arm's treatment regimens include 12 weeks of~     once-weekly isoniazid (INH) and rifapentine (3HP), 12 weeks of daily INH and rifampin (3HR),~     and 16 weeks of daily rifampin (4R). A total of 560 participants per arm (1,120 total) for~     the evaluation of safety and 1,700 participants per arm (3,400 total) for the evaluation of~     effectiveness will be enrolled, given treatment as per randomization assignment, and followed~     for 24 months from the date of enrollment.~      After completion of data collection, statistical analyses will be conducted to compare~     proportions of drug discontinuation due to adverse drug reaction (ADR) and proportions of~     newly diagnosed tuberculosis between 6wP and control arm.~   "
7092|NCT03474016|"~     Breast cancer (BC) is the most common cancer in women worldwide, and is the leading cause of~     death from cancer among women globally. Mammography is the standard method for early~     detection of BC in many countries, with over 1.3 million annually new diagnosed cases.In~     Egypt, breast cancer is the most common cancer in females accounting for 38.8% of all female~     cancers.~   "
7093|NCT03474003|"~     To further develop personalized medicine in kidney transplantation and improve transplant~     patient outcomes, attention has been given to define early surrogate endpoints that might aid~     therapeutic interventions, clinical trials and clinical decision-making.~      Despite a clear pressing need, no population-scale prognostication system exists that will~     combine traditional factors and biomarker candidates to represent the complete spectrum of~     risk predicting parameters. To adequately predict transplant patients' individual risks of~     allograft loss and allograft function trajectories, this would require a complex integration~     of data, including: donor data, recipient characteristics, transplant characteristics,~     allograft precision phenotypes, ethnicity, immunosuppressive regimen monitoring, allograft~     infections, acute kidney injuries, and recipient immune profiles.~      This project aims:~        1. To develop a generalizable, transportable, mechanistically and data driven composite~          surrogate end point in kidney transplantation;~        2. To validate several risk scores to predict kidney allograft survival and response to~          treatment of individual patients;~        3. To predict individual patient kidney function trajectories;~        4. To dynamically predict kidney allograft survival with the help of evolution overtime of~          selected clinical and biological parameters.~      Eventually, it will provide an easily accessible tool to calculate individual patients' risk~     profiles after kidney transplantation, by using datasets from prospective cohorts and post~     hoc analysis of randomized control trial datasets.~   "
7094|NCT03473990|"~     This study will aim to evaluate the efficacy of a short-term, home-based, high-intensity~     interval (HIT) programme in improving cardiovascular fitness in healthy volunteers aged 55~     and above, with an age-comparison to younger individuals taking part in the same training~     regime.~      It will also explore the efficacy of time-matched 'static' interventions for improving~     cardiovascular parameters in middle-aged females.~   "
7095|NCT03473977|"~     A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy of~     Benralizumab (Anti-IL5RA) in Subjects With Eosinophilic Gastritis.~   "
7096|NCT03473964|"~     Sarcoidosis is a multisystem granulomatous disease that can affect nearly any organ in the~     body. While most commonly affecting the lungs, vision threatening eye involvement occurs in~     approximately 25% of patients with sarcoid. Eye involvement may lead to a chronic,~     sight-threatening uveitis which may result in cataract, glaucoma, and macular edema. The~     treatment of sarcoid uveitis involves the use of topical and systemic corticosteroids or~     potent immunosuppressive agents (medications that suppress the body's immune system) both of~     which can cause severe long-term side effects. The adverse effects of steroids may be avoided~     by treatment with the use as H.P. Acthar® Gel. The effectiveness of H.P. Acthar® Gel in the~     treatment of sarcoid uveitis and patient quality of live have not been previously examined.~     These issues, will be explored in this research.~   "
7097|NCT03473951|"~     Hyperuricemia is associated with the prevalence of metabolic syndrome and cardiovascular~     risks in diverse of the population. Whether the dose-response effects on the prevalence of~     metabolic syndrome and cardiometabolic risks is unclear. The present study is conducted to~     investigate the relationship between serum uric acid and the prevalence metabolic syndrome~     and left ventricular hypertrophy.~   "
7098|NCT03473938|"~     Intragastric balloon degree of efficacy and duration of effect can be variable and~     unpredictable. The Spatz Adjustable intragastric balloon (AIGB) was developed to extend~     implantation to 1 year, decrease balloon volume for intolerance and increase volume for~     diminishing effect. The aim of the study was to determine the utility/efficacy and responder~     rate with the Spatz3 AIGB.~   "
7099|NCT03473925|"~     The purpose of this study is to assess the efficacy and safety of navarixin (MK-7123) in~     combination with pembrolizumab (MK-3475) in adults with one of three types of solid tumors:~     Programmed Death-Ligand 1 (PD-L1) positive refractory non-small cell lung cancer (NSCLC),~     castration resistant prostate cancer (CRPC) or microsatellite stable (MSS) colorectal cancer~     (CRC).~   "
7100|NCT03473912|"~     Serum, synovial fluid and skin biopsies from patients will be collected to the biobank with~     rheumatoid diseases. These samples will later be used for clinical and basic research,~     following approval of each specific study by the IRB. The investigators intend to extract~     protein, DNA and RNA from each sample.~   "
7101|NCT03473899|"~     This study tests the hypothesis that the combination of radial extracorporeal shock wave~     therapy performed with the Swiss DolorClast device (Electro Medical Systems, Nyon,~     Switzerland) and a specific rehabilitation program (hereafter, rESWT + RP) is effective and~     safe in treatment of acute hamstring muscle complex injury Type 3b, and is statistically~     significantly more effective than the combination of sham-rESWT and RP (hereafter,~     sham-rESWT + RP).~   "
7102|NCT03473886|"~     Specific Aim #1 (Feasibility; primary aim): To assess the feasibility of the positive~     psychology (PP)-motivational interviewing (MI) group-based physical activity intervention and~     outcome assessments in patients with metabolic syndrome (MetS).~      Hypothesis: The PP exercises and MI-based goal-setting sessions will be feasible: most (≥50%)~     of participants will complete 6/8 exercises/sessions. Furthermore, we will be able to obtain~     objective physical activity measurement follow-up data from at least 80% of enrolled~     participants at 8 weeks.~      Specific Aim #2 (Acceptability): To assess whether the intervention is acceptable to~     participants, as measured by ratings provided after each PP and MI exercise.~      Hypothesis: The intervention will be acceptable: participants will rate each PP and MI~     exercise with a mean score of at least 7 out of 10 on ratings of ease of completion and~     helpfulness.~      Specific Aim #3 (Outcomes): To assess whether this preliminary intervention appears to result~     in improvement of physical activity, related health behaviors (sedentary time, diet quality),~     and psychological well-being (optimism, positive affect, anxiety, depression).~      Hypothesis: The intervention will lead to improvements in physical activity, related health~     behaviors, optimism and positive affect, and reductions in depression and anxiety at 8 weeks~     compared to baseline.~   "
7103|NCT03473873|"~     In this longitudinal prospective cohort study including young people with anterior cruciate~     ligament reconstruction (ACLR), the aims are to 1) study the association between different~     measures of muscle function and early future of knee osteoarthritis (OA) assessed as~     patient-reported pain, 2) monitor the patients' functional status, and early OA development~     over time, 3) explore potential associations between muscle function and features indicative~     of early radiographic OA measured with MRI, and early detection of OA in biomarker profiles,~     respectively. The main hypothesis is that knee extensor weakness predicts future symptomatic~     OA of the knee (KOOS pain).~   "
7107|NCT03473821|"~     Anterior cruciate ligament injury is a common issue in sports involving cutting and jumping.~     Treatment may include surgical intervention followed by physical therapy, or no surgical~     intervention with the main treatment being physical therapy. Despite meeting physical~     therapist requirements for return to sport, many athletes do not return to sport. This~     discrepancy in the physical requirements for returning to sport and actually returning to the~     same physical activity level leads to the question of whether current rehabilitation~     treatments may be improved upon.~      One potential method is by integrating mental training into physical rehabilitation. By using~     mental training and increasing the meaning and relevance of rehabilitation, the athlete may~     be preparing more effectively for return to the pace and intensity common during play.~      In this study, the investigators aim to create and evaluate a model of training which~     incorporates sport/related movement and mental training in order to more effectively prepare~     athletes for return to sport after anterior cruciate ligament injury. This will be measured~     by examining functional hop measures, as well as patient-reported outcomes.~   "
7108|NCT03473808|"~     After stroke, it is common for individuals to experience hand impairment. This deficit can~     severely restrict functional ability and independence. Recovery of hand function following~     stroke is highly variable. In this study, the investigators will use brain imaging to predict~     individual response to treatment. Survivors of stroke will receive upper extremity therapy~     while they concurrently receive imperceptible vibration to the wrist aimed to enhance therapy~     outcomes.~   "
7109|NCT03473795|"~     This umbrella protocol seeks to develop robust data registries for non-communicable diseases~     (NCDs) in sub-Saharan Africa (SSA) with the aim of providing accurate and comprehensive data~     for the evaluation of such diseases in sub-Saharan African countries.Healthy volunteers will~     be included in the study for comparison.~   "
7110|NCT03473782|"~     This is a prospective cohort study study with the primary aim of identifying the strongest~     correlating parameters between voiding diaries and UDS studies most predictive for each type~     of urologic condition. Investigators will focus on OAB related conditions, as these are~     symptoms~   "
7111|NCT03473769|"~     Sepsis is a leading cause of death worldwide, and contributes to approximately 750,000~     hospitalizations per year, a third of which may die. International guidelines recommend~     timely interventions, including cultures, fluid resuscitation and antibiotics. Following~     guideline bundles is associated with a decrease in mortality. Key to timely intervention is~     timely diagnosis.~      Using the Epic sepsis predictive analytic tool, investigators will trigger vital sign and~     delirium monitoring in patients determined to be at increased risk for developing future~     sepsis.~      The primary objective of this study is to demonstrate reduced mortality in patients for whom~     the pre-sepsis algorithm threshold is met, and who enhanced monitoring.~   "
7112|NCT03473756|"~     Study 19131 is designed to evaluate safety, efficacy, RP2D and PK of rogaratinib in~     combination with atezolizumab in patients with untreated FGFR-positive urothelial carcinoma.~     The study comprises two separate parts: Phase 1b (Part A) and Phase 2 (Part B).The study~     parts differ in design, objectives and treatment.~      The primary objectives of this Phase 1b study (Part A) are to determine the safety,~     tolerability,RP2D and pharmacokinetics of rogaratinib in combination with atezolizumab in~     these patients.~      The primary objective of the Part B is to compare progression-free survival (PFS) according~     to RECIST v1.1 of rogaratinib in combination with atezolizumab over placebo in combination~     with atezolizumab in untreated patients with FGFR-positive locally advanced or metastatic~     urothelial carcinoma.~      Of note, patients who participate in Part A are not allowed to participate in Part B.~      Part B will be initiated once the data from Part A supports continuation of the study, even~     if this occurs prior to primary completion of Part A. The sponsor may decide not to continue~     the study as a whole after completion of Part A if the data do not support further~     development.~   "
7113|NCT03473743|"~     The purpose of this study is to identify the recommended Phase 2 dose (RP2D) and schedule of~     erdafitinib in combination with JNJ-63723283 (Phase 1b) and to evaluate the safety and~     clinical activity of erdafitinib alone and in combination with JNJ-63723283 (Phase 2).~   "
7114|NCT03473730|"~     Objectives:~      Primary:~      Safety and tolerability of therapy with daratumumab in a cohort of patients with metastatic~     renal cell carcinoma and a cohort of patients with muscle invasive bladder cancer.~      Secondary:~      1A. To assess the proportion of patients who achieve pathological CR with daratumumab in~     patients with muscle invasive bladder cancer.~      1B. To assess the objective response rate (ORR) to daratumumab in patients with metastatic~     renal cell carcinoma.~      2. To assess the progression free survival for patients with metastatic renal cell carcinoma~     receiving Daratumumab.~   "
7115|NCT03473717|"~     The so-called direct method of intrauterine device (IUD) and intraintuerine system (IUS)~     insertion is increasingly used. A study has shown that it is technically simpler and assumes~     less painful than the classic pose.~      It seems interesting to compare the pain felt by the patients during IUD / IUS insertion in~     these two methods of placement and also to confirm that there is no more malposition with the~     direct method.~   "
7116|NCT03473704|"~     In diabetes, web programs have been designed that have integrated cognitive-behavioral~     therapy (CBT) with diabetes education, obtaining positive results in the mood of the patient.~     In Spain, no similar approach has been performed in people with diabetes and depression.~     However, the need to provide professionals with adequate tools to help people with this~     problem is justified.~      The main objective of this project is to apply a telematic program for the treatment of~     specific depression for people with type 1 diabetes designed by our research team in a sample~     of patients with type 1 diabetes and mild-moderate depressive symptomatology of the province~     of Malaga. To do this, the sample will be divided into two groups: treatment group (TG) and~     control group (CG). The design of the study is quasi-experimental, longitudinal randomized~     pre-post with control group. The treatment group (TG) will receive the web treatment, which~     consists of 9 weekly sessions, while the control group (CG) will be evaluated in the same~     phases as the TG. For ethical reasons, the CG will receive the web treatment once the TG~     intervention has been completed. There will be a follow-up at 3, 6 and 12 months.~   "
7158|NCT03473158|"~     In this study multifetal pregnancy reduction (to twins) will be carried out through a~     transvaginal route, at an early gestational age (6 weeks - 9weeks + 6days) using 2 methods:~     mere mechanical disruption against potassium chloride injection. The 2 methods will be~     compared regarding the efficacy, complications and pregnancy outcome.~   "
7117|NCT03473691|"~     This is a single arm, pilot study assessing safety/feasibility and efficacy of neo-adjuvant~     glembatumumab vedotin (GV) in patients with high risk triple negative breast cancer (TNBC)~     with glycoprotein-NMB (gpNMB) expression ≥ 25%. Primary endpoints will be safety/feasibility,~     and secondary endpoints will be rates of pathologic complete response (pCR), and measurements~     of growth differentiation factor-11 (GDF11) and glycoprotein NMB (gpNMB) expression.~   "
7118|NCT03473678|"~     This study investigates the influence of dietary nitrate supplementation on cardiovascular~     health and physical and cognitive performance in older adults. Participants will receive both~     a nitrate containing beetroot juice for 10 days and a nitrate depleted beetroot juice for 10~     days~   "
7119|NCT03473665|"~     This is a 6-week randomized, double-blind trial of 4 different non-steroidal~     anti-inflammatory drugs in patients with axial spondyloarthritis to compare the change of~     pain score from baseline at 4 weeks to the change of pain score from baseline at 6 weeks.~   "
7120|NCT03473652|"~     The investigator propose to evaluate the interest of the provision of a suitable treadmill~     offering fall protection and verticalization assistance.~   "
7121|NCT03473639|"~     The purpose of this study is to learn about the safety and side effects of combining~     entinostat, an investigational drug, with capecitabine, a drug commonly used in breast cancer~     (BC), in both participants with metastatic breast cancer (MBC) and then participants with~     high-risk breast cancer after neo-adjuvant therapy.~   "
7122|NCT03473626|"~     Phase 1 study to compare the effect of food on alicaforsen tablet.~   "
7123|NCT03473613|"~     Giving oral Cabergoline or calcium infusion in women at high risk for developing ovarian~     hyperstimulation syndrome in context of assisted reproductive technologies aiming in its~     prevention~   "
7124|NCT03473600|"~     Alopecia areata is the most frequent cause of inflammation-induced hair loss with prevalence~     from 0.1 to 0.2%. It has no age nor sex predilection .~      Clinically, alopecia areata presents as a well-circumscribed patch of sudden hair loss. It~     affects any hair bearing area. The most common affected site is the scalp. Based on site and~     extent, AA can be classified into; diffuse, multi-locularis, mono-locularis, totalis,~     universalis, and ophiasis.~   "
7125|NCT03473587|"~     This trial will compare the effects of a culturally targeted intervention designed to assist~     participants to identify and overcome individual barriers to colorectal cancer (CRC) and to~     promote CRC screenings using motivational interviewing (Ml) delivered by a lay health advisor~     (LHA) compared to the current standard-of-care (distribution of a brochure describing CRC~     screening services offered by the hospital) on CRC screening compliance.~   "
7126|NCT03473574|"~     To determine the efficacy in terms of objective response rate (ORR) of the combination of~     durvalumab and tremelimumab in addition with gemcitabine or in addition with gemcitabine and~     cisplatin in treatment-naïve patients with advanced, unresectable and/or metastatic~     cholangio- and gallbladder carcinoma (CCA).~   "
7127|NCT03473561|"~     Efficacy and Safety of Racecadotril in the treatment of children aged 3 to 60 months~     suffering from acute diarrhea: A controlled randomized, open-label, parallel-group study~   "
7128|NCT03473548|"~     The purpose of the study is: 1) To assess the feasibility of unmonitored polysomnography and~     2) to compare apnea hypopnea index (AHI), average SPO2, and SPO2 nadir between unmonitored~     polysomnography and in-laboratory polysomnography in pediatric patients.~   "
7129|NCT03473535|"~     This study evaluates the effectiveness of a smartphone-assisted problem-solving therapy (PST)~     service across Emergency Departments in Ontario. A total of 25 Emergency Departments have~     been randomized to either usual care or the smartphone-assisted PST service intervention. The~     cohort component of this study will use data collected from consenting participants who~     presented to an intervention site's Emergency Department for self-harm. This data will be~     gathered over the course of six PST sessions, during a booster session occurring six months~     after the final therapy session, and at one year post-enrollment.~   "
7130|NCT03473522|"~     Parkinson's disease is a progressive, degenerative neurological disease associated with~     profound changes in the quality of life of its survivors. Therapeutic exercises are widely~     employed in the attempt to delay or minimize disease progression, characterized by~     significant motor and sensory deficits. Recent evidence has demonstrated the potential use of~     transcranial direct current stimulation (TDCs) as a complement to therapeutic exercises.~     However, few studies have investigated the effects of TDCs combined with therapeutic~     exercises in patients with Parkinson's disease. This study aims to investigate the effect of~     TDCs combined with therapeutic exercises in people with Parkinson's disease. Thirty patients~     will be randomized into two distinct groups to receive either TDCs(anodal) + therapeutic~     exercises or TDCs (sham) + therapeutic exercises for 24 sessions over a five-week period. The~     primary clinical outcome (balance) and secondary outcomes (functional capacity, quality of~     life and perception of overall effect) will be collected before treatment after two and five~     weeks at month 3 and month 6 after randomization. The data will be collected by a blind~     examiner to the treatment allocation.~   "
7131|NCT03473509|"~     This study examines whether a safety-net primary care CKD registry directed at the entire~     primary care team can enhance the delivery of guideline concordant CKD care, including BP~     control, ACEi/ARB use and albuminuria quantification.~   "
7132|NCT03473496|"~     Multiple myeloma（MM） is one of the most common malignant diseases in the blood system.There~     is still no cure for the disease which only control the development of the disease in various~     ways.Chimeric Antigen Receptor-transduced T cell (CAR-T) therapy is one of revolutionary~     targeted immunotherapy.The efficacy of CAR-T cells for the treatment of acute B lymphocytic~     leukemia has been widely recognized, and several clinical trials have been reported in the~     treatment of multiple myeloma with CAR-T cells.~   "
7133|NCT03473483|"~     This is an observational, crossover study that will be examine use behaviors, chemical~     exposures, and biological effects of SREC compared to TC use in subjects confined to a~     research ward setting.~   "
7157|NCT03473171|"~     The purpose of this study is to implement a standardized protocol to initiate nasal~     non-invasive ventilation with RAM nasal cannula (NIV/RAM-NC) with Trilogy mechanical~     ventilator at Children Memorial Hospital inpatient and outpatient sites, as well as to~     explore the side effects and complications associated with the use of NIV/RAM-NC in children.~   "
7134|NCT03473470|"~     A prospective randomized study of healthy term parturients undergoing cesarean delivery was~     designed to assess the impact of the active warming on perioperative and postoperative~     temperature.~      The main objective is to evaluate the maternal core temperature in the perioperative and~     postoperative period during cesarean delivery.~      The secondary objectives are to assess the incidence of maternal hypothermia, the incidence~     of maternal shivers, the evaluation of maternal thermal comfort, the neonatal temperature at~     birth, the Apgar score at 1 and 5 minutes, the umbilical pH, the evaluation of coagulative~     assessment in case of maternal hypothermia trough the use of thromboelastography.~      The patients are randomized into three groups: a group of no warmed patients, a second group~     of Active waming patients with iv fluids and lower body forced air warming and a third group~     of Active warming patients with only warmed iv fluids.~      The inclusion criteria are healthy parturients up to age 18. The exclusion criteria included~     parturients who develop fever, diabetes mellitus, BMI up to 40kg/ m2, coagulative disorders,~     pre eclampsia or eclampsia, all the factors that can cause intraoperative bleeding such as~     placental abruption or antecedent placenta overgrowth ( placenta previa).~   "
7135|NCT03473457|"~     Acute myeloid leukemia (AML) is a group of genetically highly heterogeneous malignant disease~     . The disease is the most common type of adult acute leukemia. Overall survival (OS) was less~     than 50% in 5 years. Chimeric Antigen Receptor-transduced T cell (CAR-T) therapy is one of~     revolutionary targeted immunotherapy. The efficacy of CAR-T cells for the treatment of acute~     B lymphocytic leukemia has been widely recognized, although it start late, several clinical~     trials have been register in ClinicalTrials.gov.~   "
7136|NCT03473444|"~     The prevalence of hyperuricemia has rarely been investigated in developing countries~     Hyperuricemia, or raised serum uric acid (SUA), is the condition closely associated with gout~     due to the deposition of monosodium urate crystals in peripheral joints and soft tissues.~     Hyperuricemia is associated with an increased risk for incident hypertension, independent of~     traditional hypertension risk factors. This risk appears more pronounced in younger~     individuals and women. Cross-sectional studies show an association of hyperuricemia with the~     presence of CKD. Insulin resistance plays a potentially key role in the causal relationship~     between metabolic syndrome, type 2 Diabetes and hyperuricemia. Furthermore, it is likely that~     hyperuricemia and insulin resistance share a bidirectional causal effect. The rationale of~     this study is to determine prevalence of hyperuricemia in Pakistan.~   "
7137|NCT03473431|"~     the prevalence of depression in elderly is from 4 to 30% and is associated with a lower~     quality of life mayor medical comorbidity, and increased mortality. Although there are~     various treatments for depression in the elderly, the study of interventions in resistant~     depression is limited and there are few reports of the efficacy and safety profile of~     alternative interventions such as ketamine in the elderly. The final objective of the present~     study is to report the effects of a single infusion of ketamine on the depressive symptoms in~     patients undergoing ophthalmologic surgery~   "
7138|NCT03473418|"~     Vaginal Candidiasis is an infection caused by a yeast normally lives inside the body .~     Sometimes Candida can multiply and cause an infection if the environment inside the vagina~     changes in a way that encourages its growth. Candidiasis in the vagina is commonly called a~     vaginal yeast infection. Risk factor use of intra uterine devices , pregnancy ,use hormonal~     contraceptives ,have diabetes , immune compromised taken antibiotics Diagnosis cause itching~     or soreness Pain during sexual intercourse Pain or discomfort when urinating and abnormal~     vaginal discharge Although most vaginal candidiasis is mild, some women can develop severe~     infections involving redness, swelling, and cracks in the wall of the vagina~   "
7139|NCT03473405|"~     This objective of this study is to determine whether the Air Barrier System device reduces~     airborne colony-forming units (e.g., bacteria) present at a surgery site during total knee~     arthroplasty surgeries.~   "
7140|NCT03473392|"~     The results found in the literature do not allow to define objectively the indications~     respective for a one-step or a two-step exchange of prosthetic joint. Some criteria could~     help to decide for one-step exchange or two-step exchange: bacteria is/are identified,~     profile of the bacteria, anesthetic difficulties,..~      A puncture could allow to identify the bacteria involved in the prosthetic joint infection~     (PJI) and an antibiotherapy for a few days can be given to the patient in order to decrease~     the inoculum. Then, a one-step exchange can be performed.~      The purpose of this study is to describe the management of patients who had a pre-treatment~     before a one-step exchange of their prosthetic joint.~   "
7141|NCT03473379|"~     The aim of this study is to develop and validate a patient-reported-outcome instrument~     (PROFTC-I: Patient Reported Outcome Financial Toxicity in Cancer - Italy) able to describe~     and measure financial problems of Italian patients receiving cancer treatment.~   "
7142|NCT03473366|"~     The Tao Mask is a new novel facemask for positive pressure ventilation which has recently~     been demonstrated (MUSC study Pro00047645) to have superior performance to our conventional~     (standard) positive pressure mask in a random distribution of patients with experiences~     users. This additional study will extend our investigation of the new masks capabilities by~     studying it's performance in the morbidly obese - which are more challenging patients to~     ventilate by mask. Our hypothesis is that the Tao mask will be even more effective in this~     challenging population than in the random distribution of patients.~   "
7143|NCT03473353|"~     The purpose of the study is to collect outcomes related to a quality improvement project~     assessing the feasibility and effectiveness of a medical scribe program in which medical~     scribes accompany clinicians during their visits with patients. The medical scribes involved~     in the project are professional scribes and medical students who will accompany clinicians~     during patient visits and takes notes, enabling the clinician to engage more directly with~     the patient.~   "
7144|NCT03473340|"~     Greater than 50% of lung transplant recipients show signs of chronic lung allograft~     dysfunction (CLAD) by 5 years post-transplantation.Therapies to prevent or slow CLAD are~     lacking. Anti-fibrotic therapies may offer an avenue to prevent progression of CLAD and~     prolong allograft survival. This study investigates if Pirfenidone therapy will stabilize~     lung function decline and slow progression of Functional small airways disease (fSAD) in lung~     transplant recipients with CLAD.~   "
7273|NCT03471650|"~     This is a phase II, single-center, open-label, trial to evaluate the diagnostic accuracy of~     PSMA-targeted 18F-DCFPyL PET/CT for detecting clinically significant prostate cancer in a~     screening population.~   "
7145|NCT03473327|"~     The aim of this study is to characterize the systemic stress response (SSR) induced in~     patients undergoing colorectal cancer (CRC) surgery. The project is a clinical prospective~     study. Blood samples will be collected from 30 patients on the day before CRC-surgery, and 1,~     2, 3 and 10 days after surgery. A specimen from the resected tumor tissue will also be~     collected and sent for immunohistochemical analysis. Whole blood gene expression profiling~     will be performed to gain knowledge of the genetic changes in immunological, inflammatory and~     oxidative stress-related factors initiated by surgery. Peripheral immunological cells,~     proteins and cytokines will be analysed by FLOW and ELISA methods, and the functional~     capacity of NK-cells will also be defined for each time point. Furthermore, tumor tissue will~     be analyzed for invasion of immunological cells. At each time point, the patients will be~     asked to fill out a validated patient reported outcome measure with questions concerning~     clinical outcome parameters related to recovery after CRC-surgery~   "
7146|NCT03473314|"~     An open labeled Study (NCT03331445) is demonstrating encouraging safety and efficacy results~     for most subjects receiving 160ppm nitric oxide gas (gNO) for treatment of non-tuberculous~     mycobacteria (NTM) over a 15 day treatment regimen. In one subject, who had a reduction in~     sputum culture concentration of Bacterium bolletii from plus 3 to plus 1 corresponding to a~     2-3 log10 cfu/gm reduction during the treatment, the one-week post treatment follow-up sputum~     culture had increased to plus 2. It is hypothesized that a longer treatment period may be~     necessary to fully eradicate NTM from the sputum culture in chronic lung disease. This study~     will extend the period of gNO exposure for a prolonged period of time (3 months) to attempt~     to fully eradicate the NTM in this single subject. This study will transition from the~     medical clinic to supervised delivery in the patient's home environment.~   "
7147|NCT03473301|"~     The main purpose of this study is to estimate change in motor function 12 months after~     treatment with a single dose of allogeneic umbilical cord blood (AlloCB) or repeated doses of~     umbilical cord tissue-derived mesenchymal stromal cells (hCT-MSC) in children with cerebral~     palsy. In addition, this study will contribute much needed data to the clinical trials~     community on the natural history of the motor function in CP over short-term (less than 1~     year) time periods relevant to the conduct of clinical trials and assess the safety of AlloCB~     and hCT-MSC infusion in children with cerebral palsy.~   "
7148|NCT03473288|"~     The proposed study will establish a newly-identified signaling pathway regulating both~     autophagy and apoptosis in human satellite cells. These findings will allow for novel~     pharmacological targets in satellite cells to return regenerative capacity to elderly~     individuals. Up to 80 adults, 21 years of age and greater, will undergo a consent visit~     followed by three blood draws and muscle biopsy visits- baseline (pre), after the first~     exercise bout (post-acute), and after the 12 week training program (post-chronic). Blood will~     be obtained and tested for inflammatory (IL-6/TNF/IL-1) and endocrine markers~     (Testosterone/Estrogen/Thyroid hormone). As part of the intervention, participants will~     undergo moderate intensity treadmill exercise three times per week for 10-12 weeks or serve~     as sedentary controls. Muscle stem cell function will be compared across age groups at each~     time point using a One Way ANOVA or t test for specific comparisons. An alternative analysis~     will be a longitudinal design following muscle stem cell function from each individual before~     and after exercise training. This analysis will be performed with repeated measure ANOVAs.~     Data will be analyzed using GraphPad Prism 6 statistical software. Significance will be~     accepted as p<.05. Thigh Muscle biopsies may result in momentary pain and discomfort, burning~     or bleeding, numbness, and rarely fainting or infection. The incision site may leave a scar~     and muscle soreness may be present up to ten days after the biopsy. While the local numbing~     medicine xylocaine is almost entirely free from allergic properties (such as causing hives),~     an allergic reaction is possible, and the participant will not be given xylocaine if they~     have a history of such a reaction. The xylocaine will be given by a small injection into the~     skin at the site of the muscle biopsy. Risks associated with a standard blood draw include~     momentary discomfort and/or bruising. In addition, there is a minimal risk of infection,~     excess bleeding, clotting, and fainting. An exercise program may result in muscle, bone~     and/or joint soreness, discomfort and/or injury. All collected data will be stored in a~     locked file to be accessed only by Dr. White and his study staff. Study records that identify~     subjects will be kept confidential as required by law.~   "
7149|NCT03473275|"~     This study will explore the brainstem activity in response to stress in hypertensive patients~     and normotensive subjects. In addition, it will evaluate if the response in hypertensive~     patients can be modulated by blocking the afferent signalling of sympathetic nervous system~     from the kidney to the brain achieved by renal denervation.~      The investigators hypothesize that the change in BOLD signal intensity in response to stress~     is higher in hypertensive patients than in normotensive subjects and that in patients~     responsive to renal denervation the change in BOLD signal intensity in response to stress is~     decreased compared to non-responders or to non-denervated resistant hypertensive patients.~   "
7150|NCT03473262|"~     This study evaluates the efficacy and safety of the empagliflozin as add-on thearpy compared~     to insulin glargine-based antidiabetic agents (OADs) combination thearpy in patients with~     type 2 diabetes inadequately controlled on triple OADs in a real clinical practice.~   "
7151|NCT03473249|"~     The purpose of the study is to generate pilot data describing test characteristics of~     contrast enhanced ultrasound in young children with concern for abdominal trauma. The primary~     objective in this study is to determine the sensitivity and specificity of contrast-enhanced~     ultrasound (CEUS) compared to abdominal Computed Tomography (CT) in the detection of~     abdominal solid organ injury in young children < 8 years of age with concern for blunt~     abdominal trauma.~   "
7152|NCT03473236|"~     This is a phase 1A randomized double blind placebo controlled single ascending dose and~     multiple ascending dose trial of inhaled PK10571 in healthy adult subjects~   "
7153|NCT03473223|"~     This is a phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group~     study to evaluate the efficacy and safety of CSL112 on reducing the risk of major adverse CV~     events [MACE - cardiovascular (CV) death, myocardial infarction (MI), and stroke] in subjects~     with acute coronary syndrome (ACS) diagnosed with either ST-segment elevation myocardial~     infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI), including~     those managed with percutaneous coronary intervention (PCI) or medically managed.~   "
7154|NCT03473210|"~     A randomized controlled trial that involved 100 women diagnosed with PPROM between 24 and 34~     weeks of gestational age. Participants were randomized equally into 2 groups. Group I in~     which amniopatch was done (an amnioinfusion of platelet concentrate followed by fresh frozen~     plasma in addition to the routine management used in the control group. Group II were treated~     with routine management including antibiotics and corticosteroids~   "
7155|NCT03473197|"~     A study in healthy male and female adult volunteers to determine the potential of CCP-020~     (Diacerein 1%) Topical Ointment to induce a photoallergic skin reaction using a controlled~     photopatch testing procedure.~   "
7159|NCT03473145|"~     Epidemiological findings indicate that older adults do not meet physical activity (PA)~     guidelines & spend up to 11 hrs/day sitting. Given the high prevalence of sedentary behavior~     (SB), the higher chronic disease risk in this population, & the age-associated challenges of~     meeting traditional PA guidelines, involving longer bouts of moderate PA, the investigators~     hypothesize that older adult health will benefit from new strategies to interrupt sitting.~     This protocol Sedentary Behavior Interrupted: A randomized trial of 3-month effects on~     biomarkers of healthy aging and physical functioning in the real world (Project 2) is part~     of a National Institutes of Aging Program Grant called Sedentary Time & Aging Mortality and~     Physical Function (STAR). The overall purpose of the STAR program to is to better understand~     how to interrupt sitting time and the consequences for healthy aging in postmenopausal women.~     This protocol (also referred to Project 2 of the STAR program) is a 3-arm randomized control~     trial designed to assess ways of interrupting sitting in 405 overweight, postmenopausal~     women.~   "
7160|NCT03473132|"~     Prospective assessment of vitamin K dependent coagulation factor levels after temporary~     warfarin reversal in participants with left ventricular assist devices (LAVD).~   "
7161|NCT03473119|"~     Pneumonia is a major infectious cause of death worldwide and imposes a considerable burden on~     healthcare resources. Obstructive lung diseases (COPD and Asthma) are increasingly important~     causes of morbidity and mortality worldwide. The patients with community-acquired pneumonia~     (CAP), and acute exacerbations of obstructive lung diseases commonly present with similar~     signs and symptoms. For antibiotic use, the rapid and accurate differentiation of clinically~     relevant of bacterial lower respiratory tract infections from other mimics is essential.~     Sphingosine-1-phosphate (S1P) is a bioactive sphingolipid has both extracellular and~     intracellular effects in mammalian cells. S1P is involved in many physiological processes~     including immune responses and endothelial barrier integrity. In term of endothelial barrier~     integrity, S1P plays a crucial role in protecting lungs from the pulmonary leak and lung~     injury. Because of the involvement in lung injury, S1P would be the potential biomarker of~     pneumonia. Based on the above evidence, S1P plays an essential role in the pathobiology of~     pneumonia was hypothesized.~   "
7162|NCT03473106|"~     The use of a pneumatic tourniquet with the purpose of maintaining an operative field free of~     blood is a common practice in orthopedic surgery. Its use is associated with local and~     systemic consequences related to hemodynamic and reperfusion ischemia phenomena. Although is~     known that its use is not an innocuous measure, there is still certain degree blurriness~     regarding the potential metabolic and functional consequences that may result in the involved~     limb.~      In this trial, the investigators are setting out to discriminate the effect of the pneumatic~     tourniquet on thigh muscle function (strength, tone and activation). The hypothesis is that~     the pneumatic tourniquet by itself causes a significant postoperative muscular dysfunction of~     the quadriceps and, thus, the main outcome will be the presence of postoperative quadriceps~     muscle dysfunction, defined as a fall greater than or equal to 10% of the maximal voluntary~     isometric contraction measured at 24 hours post surgery.~   "
7163|NCT03473093|"~     Determine the effect of using oral pregabalin on the analgesic effects of IV infusion of~     morphine in patients with multiple fracture ribs.~   "
7164|NCT03473080|"~     This study is a feasibility study of Internet-delivered CBT for OCD in children and~     adolescents (7-17 years) with comorbid Autism Spectrum Disorder.~   "
7165|NCT03473067|"~     Dating and sexual violence are significant public health concerns occurring on a continuum of~     severity across the lifespan, with serious consequences to victims and society. The present~     research advances the science of prevention by rigorously evaluating a comprehensive social~     norms marketing campaign to promote community-level change in dating and sexual violence in~     middle schools. Partnership between researchers and a CDC Rape Prevention and Education~     Program (RPE) funded agency is a core feature of this work, and aims to build community~     capacity to implement and evaluate violence prevention efforts, and promote the subsequent~     uptake of social norms marketing campaigns as a strategy for reducing dating and sexual~     violence among youth.~   "
7166|NCT03473054|"~     Stroke survivors and their family caregivers often experience stress, anxiety, and~     depression. The psychological wellbeing of stroke survivors and family caregivers is thought~     to be interconnected and can have an important role to play in rehabilitation outcomes.~     Mindfulness meditation can help improve psychological wellbeing, but it often involves people~     attending groups by themselves and engagement can be poor. One solution is for stroke~     survivors and family caregivers to learn mindfulness meditation together online.~      This study aims to explore the feasibility, appropriateness, meaningfulness, and~     effectiveness of mindfulness meditation delivered online for stroke survivor and family~     caregiver partnerships.~   "
7167|NCT03473041|"~     a hybrid sling formed of a central part of autologus rectus sheath (2×6 cm) and two arms of~     polypropylene mesh (2×10cm) versus transobturator tension free vaginal tape(TVT-O)~   "
7168|NCT03473028|"~     to evaluate the value of using transvaginal ultrasound guided embryo transfer in obese~     patients undergoing in vitro fertilization.~   "
7169|NCT03473015|"~     The OxAMI-PICSO is a study about the use of pressure controlled intermittent coronary sinus~     occlusion (PICSO) to improve the treatment of patients presenting with heart attack. PICSO is~     a device consisting of a balloon which is deployed in the coronary sinus. When inflated the~     balloon can improve the blood flow to the region of heart affected by the heart attack. The~     study aims to analyse the potential benefit of PICSO in improving blood flow to heart muscle~     in a selected group of patients admitted with a large heart attack involving the anterior~     wall of the heart. The comparator group will be a well-matched group of participants of the~     ongoing OxAMI study.~      In order to select patients with a large heart attack, we will measure the index of~     microcirculatory resistance (IMR), before completion of the heart attack treatment procedure.~     The IMR value provides measurement of the blood flow at the level of the tiny vessels~     branching from the large coronary arteries. Our preliminary data from the OxAMI study have~     shown that an IMR > 40 suggests that the patient is having a large myocardial infarction~     (heart attack). Only patients with starting IMR > 40 will be considered eligible for the~     PICSO treatment.~      The benefit of PICSO will be assessed by measuring 1) indexes of coronary blood flow, 2) the~     extension of the infarcted area and 3) the levels of different molecules released in the~     blood.~   "
7170|NCT03473002|"~     This is a Phase I randomized, double blind, placebo controlled trial in up to 25 males and~     non-pregnant females, 18-45 years old, inclusive, who are in good health and meet all~     eligibility criteria. This trial is designed to assess the safety, reactogenicity and~     immunogenicity of a single intranasal dose of Sendai virus vectored Respiratory Syncytial~     Virus (SeVRSV) vaccine. The subjects will be randomized in a 4:1 ratio to receive SeVRSV~     vaccine at a dose of 1 x 10^7 EID50 or placebo (saline) intranasally. Study duration is~     approximately 11 months with subject participation duration approximately 6 months. The~     primary objectives are to: 1) assess the safety and reactogenicity of SeVRSV vaccine~     following receipt of one intranasal dose; 2) assess the ELISA antibody responses to SeV and~     to the RSV F protein at 28 days post receipt of one intranasal dose of SeVRSV vaccine; 3)~     assess the detection of vaccine virus from nasal washes at days 3, 5, 8 and 15 following~     receipt of one intranasal dose of SeVRSV vaccine.~   "
7171|NCT03472989|"~     The purpose of this study is to evaluate whether radial extracorporeal shockwave therapy~     (rESWT), sham rESWT or standardized exercise program is more effective on heel pain than~     usual care in the treatment of plantar fasciopathy.~      The null hypothesis is: There is no difference between rESWT, sham- rESWT or standardized~     exercise program on change in heel pain compared to usual care in the treatment of plantar~     fasciopathy at 6 months follow-up.~      Alternative hypothesis is:~      H1: There is a difference between rESWT and usual care on change in heel pain at 6 months~     follow-up.~      H2: There is a difference between sham-rESWT and usual care on change in heel pain at 6~     months follow-up.~      H3: There is a difference between standardized exercise program and usual care on change in~     heel pain at 6 months follow- up.~      We will perform a subgroup analysis on the patients who have no previous experience in~     receiving rESWT.~   "
7172|NCT03472976|"~     Phase I randomized, double-blind, placebo-controlled trial in 50 males and non-pregnant~     females, 18 to 49 years old, who are in good health and meet all eligibility criteria. This~     clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of~     inactivated A/H5N1 influenza vaccine administered intradermally (ID) with topical Aldara or~     control cream as a 2-dose regimen. The vaccine will be administered using the MicronJet600™~     device. Subjects will be assigned to 2 treatment arms (25 subjects per treatment arm). Group~     A will receive two doses of A/H5N1 IIV ID with pre-application of topical Aldara on Days 1~     and 22. Group B will receive two doses of A/H5N1 IIV ID with pre-application of topical~     control cream on Days 1 and 22. The duration of this study will be approximately 20 months~     with patient participation duration approximately 7 months. The primary objectives of this~     study are: 1) to assess the safety and reactogenicity after 2 doses of A/H5N1 IIV vaccine~     containing 9 mcg HA per dose administered ID approximately 21 days apart with topical Aldara~     or control cream; 2) to assess the serum HAI antibody responses 21 days after receipt of the~     2nd dose of A/H5N1 IIV administered ID at 9 mcg HA per dose with topical Aldara or control~     cream.~   "
7173|NCT03472963|"~     This study is being conducted to determine if the uptake of anti-HIV medications called~     Genvoya® and darunavir is different at several body sites, including mucosal tissues.~   "
7174|NCT03472950|"~     The purpose of this research study is to evaluate the safety and effectiveness of Ranolazine,~     and how well it is tolerated in patients with Amyotrophic Lateral Sclerosis (ALS). Ranolazine~     is an FDA approved drug that is used for decreasing chest pain.~   "
7175|NCT03472937|"~     The investigators are performing a randomized controlled trial investigating starting~     cervical ripening in the outpatient setting with a mechanical method, the transcervical Foley~     catheter. The objective of the study is to determine if outpatient compared to inpatient~     cervical ripening with a transcervical Foley catheter in nulliparous women undergoing~     induction shortens the time spent in labor and delivery (from the time of admission to the~     time of delivery).~   "
7176|NCT03472924|"~     This study evaluates whether the use of Kinesio Tape® in combination with a standard exercise~     program improves muscle function in individuals with chronic ankle instability. Twenty~     participants will receive Kinesio Tape® and perform an ankle exercise program, while twenty~     will perform the ankle exercise program without Kinesio Tape®.~   "
7177|NCT03472911|"~     In this study, the primary objective was to estimate the minimum effective volume of~     bupivacaine 0.5% resulting in successful block in 50% of patients (MEV50) for~     ultrasound-guided retroclavicular approach to infraclavicular brachial plexus block.~   "
7178|NCT03472898|"~     The investigators present an interesting co-incidence of Gated wall abnormality in the~     inferolateral wall in normal sestamibi myocardial perfusion images with J wave in the~     inferior derivations of the ECG in a patient. The subsequent coronary angiography~     demonstrated 80% mid right coronary artery (RCA) stenosis, which was intervened with a~     drug-eluting stent. The investigators conclude that even though the myocardial perfusion is~     normal, the association of gated wall abnormality with J wave presentation within the same~     location should be further evaluated.~   "
7179|NCT03472885|"~     To determine the effectiveness of ACH-0144471 in improving anemia when given with eculizumab~     for 24 weeks in patients with PNH.~   "
7180|NCT03472872|"~     This randomized, double-blind trial will compare the clinical efficacy of IV acetaminophen to~     that of IV ketorolac as adjuncts to standard therapy (prochlorperazine and diphenhydramine)~     in the treatment of patients presenting to the emergency department with chief complaint of~     headache or variants thereof.~   "
7181|NCT03472859|"~     The goal is to compare a novel yellow laser, based on semiconductor technology, with~     traditional green laser, in the treatment of cheek telangiectasias. The trial design is~     randomized split-face double-blinded study with 20-30 volunteers. The improvement will be~     assessed using a 7-point Telangiectasia Grading Scale.~   "
7182|NCT03472846|"~     The aim of this study is the quantitative determination of bone-specific microRNAs in the~     serum of postmenopausal women with osteoporosis during antiresorptive or osteoanabolic~     therapy.~   "
7274|NCT03471637|"~     This research aims to study how Compassion-Focused Therapy (CFT) might work for people with~     chronic pain. People with chronic pain may feel shameful about their condition and this type~     of therapy aims to help people to view themselves and their difficulties in a kinder, less~     critical way (i.e. self-compassion). Currently, no research is available on the effectiveness~     of CFT in helping people with chronic pain.~      Participants attending a CFT-incorporated Pain Management Programme will complete a battery~     of questionnaires at the start of the group (week 1), in the middle of the group (week 5) and~     at the end of the group (week 11).~   "
7183|NCT03472833|"~     Different studies have shown that a deficiency in vitamin D (≤20ng/mL) results in higher~     rates in morbidity and mortality rates in cancer patients. Clinical studies investigated and~     demonstrated altered vitamin d tissue in pancreatic cancer. But there is no prospective study~     evaluating the beneficiary effects of oral supplementation of vitamin d in altered vitamin d~     tissue from pancreatic cancer. We want to examine the effect of a high dose vitamin D3~     therapy vs. a standard base dose vitamin D3 therapy in pancreas cancer patients with a~     vitamin D deficiency. In case of benefit in our results we could implement vitamin D3 as a~     supportive standard therapy in pancreatic cancer patients.~   "
7184|NCT03472820|"~     The maintenance of health and the progression of disease are associated with an individual's~     genetic make-up and environmental factors, including lifestyle choices (such as diet,~     exercise, behaviors, stressors, sleep, tobacco and alcohol use), environmental exposures and~     socioeconomic determinants. Environmental factors have been shown to influence, sometimes~     rapidly, epigenetic processes thereby influencing genetic expression. Regulation of the human~     genome by the epigenome is now regarded as a cornerstone, heritable, physiologic process,~     playing a key role in phenotypic expression of health and disease.~      DNA methylation is a well-researched, primary epigenetic process. Aberrant DNA methylation~     resulting in hyper- or hypomethylated regions of the genome, generally results in inhibition~     or expression of certain genes and has been associated with the pathogenesis of numerous~     conditions, ranging from inflammation and accelerated aging, to cancer, autoimmunity,~     diabetes, heart disease, dementia, allergic disease, posttraumatic stress disease and others.~     Likewise, certain healthy diet and lifestyle habits have been demonstrated to favorably~     influence DNA methylation patterns.~      Understanding that environmental factors can potently and sometimes rapidly, favorably or~     negatively influence epigenetic expression, a short-term diet and lifestyle intervention may~     significantly augment DNA methylation expression.~      The purpose of this study is to evaluate a 9-week diet and lifestyle intervention on~     patient-reported quality of life, symptoms, and DNA and biochemical methylation-related~     biomarkers in healthy males ages 50-72.~   "
7185|NCT03472807|"~     Other than high-dose radiation and previous chemotherapy, few strong risk factors have been~     identified as causes of childhood cancer. Geneticists estimate that 5 to 10% of all cancers~     diagnosed during the paediatric period occur in children born with a genetic mutation,~     increasing their lifetime risk of neoplasia. Such genetic risk is higher in children with~     congenital anomalies and specific genetic syndromes. Some germline genetic alterations are~     well known (e.g. P53 protein (P53), Neurofibromatosis type 1(NF1)), however many children~     with none of these mutations have clinical presentations that strongly suggest the~     involvement of a genetic predisposition. Comprehensive genetic testing for all such patients~     is an important factor for improving disease surveillance. Such opportunities are now~     available thanks to whole exome sequencing (WES). In oncology, an important clinical~     application of WES will be to routinely identify mutations associated with inherited cancer~     predispositions and to guide cancer risk-management decisions.~      Our project is a national translational multicenter genetics study aimed at identifying genes~     involved in paediatric cancer predisposition by WES in a very select population of children~     with both developmental delay and cancer. Our project relies on the TED register (Tumeur Et~     Développement), an initiative by the French organisation SFCE (Société Française de lutte~     contre les Cancers et les leucémies de l'Enfant et de l'Adolescent) involving 30 child cancer~     units in France. This database includes the information of more than 500 paediatric cancer~     patients with congenital abnormalities. The investigators plan to sequence the germline and~     tumour exome of 100 patients with developmental delay in a trio-design consisting of 300~     people and 100 tumours.~      The investigators believe that the ExoCaRe project will provide answers to the genetic~     origins of certain particular childhood cancers. The ExoCaRe project relies on a genetic~     study to identify genetic risk factors for rare forms of childhood cancer and aims to~     establish more personalised treatment. It is aimed at improving genetic counselling for~     families and will be fully integrated in the genetic counselling process. The information~     provided by our study will be used to improve the management approach to an initial cancer by~     clarifying the risks of other cancers in related families. The investigators hope to identify~     new germline genes predisposing to cancer that will be of interest in understanding tumour~     biology.~   "
7186|NCT03472794|"~     The project is imbued with the whole problematic of patient follow-up and patient support,~     taking into account the experiences and needs of breast cancer patients. It concerns the~     dissemination of knowledge through the implementation of a specific clinical innovation~     designed to optimizing breast cancer patient pathway. The  Patients en réseau  association~     offers us to participate at the web platform evolution Mon Réseau Cancer du Sein in adapting~     it. The feasibility study focuses on (1) the platform utilization and (2) sources and~     obstacles to its utilization in the French context~   "
7187|NCT03472781|"~     Data on demographics, etiology, clinical features, diagnosis, secondary complications,~     treatment and outcomes of intraocular inflammation in children aged 16 years and below that~     presented to uveitis clinic in Singapore National Eye Centre (SNEC) from January 1989 to~     January 2017, will be retrieved and analyzed from the uveitis database retrospectively.~      The results will be compared with other published studies on different study populations.~   "
7188|NCT03472768|"~     Newborns and children with life-threatening heart and lung failure may require support with~     ECMO (extracorporeal membrane oxygenation). With ECMO, oxygen and carbon dioxide are~     exchanged and circulated throughout the body even if the heart is unable to do so.~     Unfortunately, ECMO can cause breakdown of the red blood cells (known as hemolysis). For~     unclear reasons, newborns are at particularly high risk of hemolysis while being supported by~     ECMO. The amount of hemolysis is measured with concentrations of a breakdown product from red~     blood cells known as free hemoglobin. One possible reason for high free hemoglobin levels in~     newborns on ECMO could be related to another blood protein called haptoglobin. Haptoglobin is~     known to help in clearing free hemoglobin through the kidneys into the urine. However,~     haptoglobin levels in newborns can be very low and increases slowly during the first few~     months of life. Free hemoglobin may be inappropriately high in newborns supported by ECMO~     because of low levels of haptoglobin. The purpose of this study is to characterize~     haptoglobin, free hemoglobin, and hemolysis in newborns and children supported by ECMO and~     compare those values to age-matched newborns and children not on ECMO.~   "
7189|NCT03472755|"~     Recent increased interest in tissue-sparing and minimally invasive arthroplasty has given~     rise to a sharp increase in the utilization of direct anterior total hip arthroplasty.~   "
7190|NCT03472742|"~     This is a follow-up study to assess safety and preliminary clinical activity of ADR-001 in~     patients with liver cirrhosis (Child-Pugh score; Grade B) caused by Hepatitis C or~     Nonalcoholic Steatohepatitis. Patients who have already participated in the ADR-001-01 study~     and completed the last evaluation after 24 weeks of administration will be eligible to this~     study.~      Patients registered will continue follow-up observation and evaluate long-term safety and~     exploratory efficacy.~   "
7275|NCT03471624|"~     Primary Objective:~      To describe rate of persistence and/or improvement of viral suppression with TAF as with~     previous anti-HBV (hepatitis B virus) treatment~   "
7191|NCT03472729|"~     AGE-ON is a series of workshops developed by the Regional Geriatric Program central, based in~     Hamilton, Ontario. The goal of these workshops is to teach older adults with limited computer~     knowledge how to use tablet computers to connect with friends and family and gather~     information related to issues of importance to them. The overwhelming positive response to~     three initial pilots proved the interest in such a program from seniors in the community.~     Preliminary feedback from program participants was collected as part of the initial pilot;~     the investigators would now like to use this feedback to improve the existing workshops and~     expand implementation of the program to a diverse population of older adults. The objective~     of this study is to conduct a formal mixed-methods evaluation of the updated AGE-ON workshops~     implemented at multiple community-based sites.~   "
7192|NCT03472716|"~     The primary objective of this trial is to evaluate the correlation between the intensity of~     the protein big-h3 expression at tumoural microenvironment and the TNM/UICC staging (from I~     to IV) of pancreatic adenocarcinoma lesion.~   "
7193|NCT03472703|"~     To get a better understanding of the interaction between metabolism, neural responses,~     cognitive processes and appetite the investigaters will examine the effect of food~     consumption on cognitive processes. The investigaters will look at the effect of satiation on~     cognitive performance on both a behavioural and neuronal level. In this study participants~     will undergo functional magnetic resonance imaging (fMRI) measurements while performing a~     food reward and inhibition task, and in addition perform a memory, working memory and delay~     discount task, once when hungry and once when full.~   "
7194|NCT03472690|"~     The QBECO-CD-02 trial in subjects with moderate to severe Crohn's disease (CD) is intended to~     build on past experience with QBECO SSI and further establish the safety and efficacy of~     QBECO SSI for the induction of clinical and/or endoscopic response and remission.~      The study will be conducted in three stages; a Lead-in, Main Induction and Main Maintenance~     .The first 20 patients will be enrolled in the Lead-in study, at approximately 5 study~     centers in Canada. Subsequent patients will be enrolled in the Main study, which aims to~     enroll 150 patients. The Lead-in component will be an open-label study to evaluate endoscopic~     healing endpoints. The Main Induction study will be randomized and placebo-controlled.~     Participants meeting response criteria following the Main Induction study will be eligible to~     continue into the Main Maintenance study, remaining on their initially randomized treatment.~     Participants not meeting response criteria will complete their follow-up and study~     involvement at the end of the Main Induction.~   "
7195|NCT03472677|"~     A clinical study to measure the effects of injection-site cooling on pain experienced after~     knee injections of capsaicin in healthy subjects and in patients with knee osteoarthritis.~   "
7196|NCT03472664|"~     The Brain Energy for Amyloid Transformation in AD (Alzheimer's disease) or BEAT-AD study will~     compare the effects of a ketogenic low-carbohydrate diet and a low-fat diet in adults with~     mild cognitive impairment. The data collected will help determine whether diet interventions~     induce changes in cognitive function, cerebral blood flow, and levels of certain proteins and~     hormones in body fluids.~      The study will include volunteers who have mild cognitive impairment, who will be randomly~     assigned to receive either a ketogenic low-carbohydrate diet or a low-fat diet for 16-weeks,~     with follow-up assessment 8 weeks after diet completion. Study measures, clinic visits and~     phone sessions will occur at baseline and throughout the 24-week study.~      Group 2 will include volunteers who have mild cognitive impairment. This group will complete~     a 16-week low-fat diet study, with follow-up assessment 8 weeks after diet final completion.~     Study measures, clinic visits and phone sessions will occur throughout the 24-week study.~      Participant will follow either a low-carbohydrate or low-fat diet that will be individually~     planned with help from a study dietitian. After completing the study diet for 16 weeks,~     participants will resume their normal diet. The final visits will occur at week 24 (8 weeks~     after the completing the diet). At the end of the 24-week study, participants will be given~     the opportunity to meet with the study dietitian for education and assistance with planning a~     healthy diet.~   "
7197|NCT03472651|"~     The purpose of this study is to establish bioequivalence of flupentixol/meltracen, between a~     new film-coated tablet formulation and the marketed coated tablet formulation (Deanxit®),~     administered single dose in fasted and fed condition~   "
7198|NCT03472638|"~     This randomized trial with a crossover design will examine the efficacy of rTMS targeting the~     dorsomedial prefrontal cortex as a treatment for medication-resistant major depression in~     patients meeting diagnostic criteria for borderline personality disorder.~   "
7199|NCT03472625|"~     The objective of the study is to estimate the incidence and recovery of aphasia, dysarthria~     and dysphagia in an acute setting (first week) with the NIHSS sub-item scores for language~     and speech and a dysphagia screening.~      Furthermore, we will evaluate the severity of aphasia, dysarthria and dysphagia in an acute~     setting (first few days) with standardized measurements (ScreeLing, BNT, NSVO-Z, perceptual~     assessment, MASA/FOIS).~      To evaluate the effect of early IVT/EVT in patients with ischemic stroke on functional~     outcomes for language and speech via the NIHSS scale.~   "
7200|NCT03472612|"~     Continuous positive airway pressure (CPAP) therapy is the most effective Treatment for~     obstructive sleep apnoea (OSA ). However, adherence to CPAP is often limited. There are~     established and emerging treatment alternatives to CPAP available, however, they are usually~     less effective than CPAP. To develop novel treatment methods and to predict who will respond~     to which treatment, the mechanism underlying obstructive sleep apnoea and different patient~     types should be described. Especially the contribution of the upper airway function and~     central respiratory control should be studied for this purpose. In a prospective~     interventional study, patients with OSA effectively treated with CPAP will undergo~     physiologic measurements during a two week period off CPAP to define the pathophysiological~     mechanisms associated with OSA recurrence. This knowledge could facilitate individually~     tailored treatment and improve therapy adherence and patient outcomes.~   "
7276|NCT03471611|"~     How safe and effective are CD34+ cell intracoronary injections for treating coronary~     endothelial dysfunction (CED)?~   "
7301|NCT03471286|"~     This is a single-institution, single arm, open label, window of opportunity clinical trial~     that will act as a Master Protocol with a primary objective to assess pharmacodynamic effects~     of the novel study drugs in subjects with resectable solid tumor malignancies.~      Each Sub-protocol conducted under the Master Protocol will evaluate different novel~     therapeutic agent(s).~      Estimated enrollment is 15 subjects per Sub-Protocol.~   "
7201|NCT03472599|"~     Bladder spasms after spinal cord injury (SCI) can result in incontinence, urinary tract~     infections, kidney damage, trigger dangerous increases in blood pressure and decrease~     independence and quality of life. The investigators' long-term goal is to develop and provide~     a bladder pacemaker able to restore bladder continence for Veterans with SCI. Electrical~     stimulation of sensory nerves can stop bladder spasms during a doctor visit. However, this~     approach has not been tested during long term home use. This proposal will 1) determine how~     well sensory stimulation reduces incontinence and improves quality of life for Veterans with~     SCI during 1 year of home use, and 2) produce an effective take home system that can be used~     by more Veterans and other VAs.~   "
7202|NCT03472586|"~     This phase II trial studies ipilimumab and nivolumab with immunoembolization in treating~     participants with uveal melanoma that has spread to the liver. Monoclonal antibodies, such as~     ipilimumab and nivolumab, may interfere with the ability of tumor cells to grow and spread.~     Immunoembolization may kill tumor cells due to loss of blood supply and develop an immune~     response against tumor cells. Giving ipilimumab and nivolumab with immunoembolization may~     work better in treating participants with uveal melanoma.~   "
7203|NCT03472573|"~     This phase I trial studies the side effects and best dose of palbociclib when given together~     with dexamethasone in treating participants with B-cell acute lymphoblastic leukemia that has~     come back after a period of improvement or does not respond to treatment. Palbociclib may~     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~     Dexamethasone is a steroid medication that is used in combination with other medications to~     treat B-cell acute lymphoblastic leukemia. Giving palbociclib together with dexamethasone may~     work better in treating patients with B-cell acute lymphoblastic leukemia.~   "
7204|NCT03472560|"~     This is a Phase 2 study to evaluate the safety and efficacy of avelumab in combination with~     axitinib in patients with advanced or metastatic non-small cell lung cancer (NSCLC) who have~     received at least one prior platinum containing therapy, and in treatment naïve patients with~     advanced or metastatic urothelial cancer, who are ineligible for cisplatin containing~     chemotherapy for their advanced disease.~   "
7205|NCT03472547|"~     Single center, randomized, controlled, evaluator blinded, within-subject comparison study to~     evaluate the sensitization potential of CCP-020 (Diacerein 1%) Topical Ointment on normal~     skin.~   "
7206|NCT03472534|"~     Single center, randomized, controlled, evaluator blinded, within-subject comparison study to~     evaluate the irritation potential of CCP-020 (Diacerein 1%) topical ointment on normal skin.~   "
7207|NCT03472521|"~     Our previous work has identified the group of women at risk for prolonged pain, opioid use~     and poor functional recovery after childbirth. The optimal intervention to mitigate this risk~     is unknown. We propose to test an analgesic adjutant that is commonly used for post-operative~     pain compared to placebo to improve post-partum recovery.~   "
7208|NCT03472508|"~     This is a multicenter, randomized, double-blind, controlled clinical trial. It aims to~     investigate the effects of different doses of folic acid on lowering homocysteine (Hcy) in~     patients with hypertension with different genotypes of MTHFR C677T and to determine a~     dose-response relationship.~      This study consists of 3 phases: Screening ( 2-10 Days ), Run-in period (2 Weeks),~     Double-Blind Treatment (8 Weeks). Follow-up visits will take place at the beginning of both~     the Run-in Period and the Double-Blind Treatment Period, and at the end of the 2nd, 4th, 6th,~     and 8th weeks. No medications that could affect the assessment of efficacy may be taken~     during any stage of the study.~   "
7209|NCT03472495|"~     The primary objective of this study is to compare the incidence of rate control (defined as:~     HR <110 beats/min or conversion to sinus rhythm) at 2 hours after medication administration~     between oral immediate release diltiazem and intravenous continuous infusion diltiazem.~   "
7210|NCT03472482|"~     In this observational study, the investigators aim to evaluate whether changes in the retinal~     and choroidal circulation, as assessed by Optical Coherence Tomography (OCT) and the~     quantification of retinal amyloid deposits using auto-fluorescence and hyperspectral retinal~     imaging, are correlated with the degree and subtype of dementia and with the presence or~     absence of a positive amyloid scan.~      For this purpose, patients with established Alzheimer's Disease (AD) and Lewy Body Dementia~     (LBD), as well as amyloid positive and amyloid negative Mild Cognitive Impairment (MCI) and~     aged matched cognitively intact patients will be included in this cross-sectional study.~   "
7211|NCT03472469|"~     This is a comparative effectiveness study of current pain management strategies in acutely~     injured trauma patients. Two different multi-modal, opioid minimizing analgesic strategies~     will be compared.~   "
7212|NCT03472456|"~     The objective of the study is to determine which of the two commonly used endodontic~     medications (Eugenol VS Articaine) is most effective in controlling postoperative pain in~     irreversible pulpitis of the mature permanent tooth in adults. To do so, an assessment of the~     pain felt by patients will be carried out a few days apart. The supposed results are that the~     medications are equivalent in terms of effectiveness on the pain, but could then present~     different economic arguments~   "
7213|NCT03472443|"~     Background:~      Prevalence of de Quervain's Tenosynovitis (dQt) is estimated at 0.5% among men and 1.3% among~     women. As there is an increasing length of time in smart phone usage, the prevalence is~     believed to be higher in the future. However, the public has a common avoidance of~     corticosteroid usage.~      Although the surgical treatment of the disease is reported to be effective in providing long~     term relief, its complications include radial sensory nerve injury, incomplete decompression,~     and volar subluxation of the tendons. The above factors raised the need of alternative~     treatments.~      Sinew Acupuncture is a new acupuncture technique developed based on the Jing-jin theory from~     Huangdi Neijing the tradition Chinese Medicine classic literature. Previous observational~     studies indicated that sinew acupuncture had the immediate analgesic effect on soft tissue~     injuries at various locations. It is a subcutaneous and transverse needling which minimizes~     the pain, sore, swelling sensations of acupuncture. A controlled study includes longer~     follow-up is needed for providing evidence for this alternative treatment , which is safe and~     with the least undesired sensation.~      Aims:~        1. To determine whether sinew acupuncture can reduce pain (measured by Visual Analogue~          Scale VAS) of dQt patients.~        2. To determine whether sinew acupuncture can reduce disability (measured by pinch~          strength, grip strength and the Quick Disabilities of the Arm, Shoulder, and Hand Q-DASH~          questionnaire ) of dQt patients.~        3. To determine whether sinew acupuncture can improve life quality (measured WHOQOL-BREF~          Quality of Life Questionnaire) of dQt patients~      Design:~      A randomised subject trial will be employed. A total of 68 cases will be recruited in the~     study and allocated into study and wait-list control group under ratio 1:1. Treatment group~     participants will receive 5 treatments in 2 weeks and follow-up sessions after 6 and 12~     weeks. Wait-list control group participants will receive same treatment and assessment after~     waiting and follow-up period. Both groups will receive health education session on dQt. The~     subjects are prohibited from receiving corticosteroid injection for treating de Quervain's~     Tenosynovitis. The subjects are recommended not to receive any other treatments for dQt~     during the trial period; Rescue medication for pain is allowed if patients have intolerant~     pain. Any treatments or medications for dQt received should be reported and recorded.~      Setting:~      The Hong Kong Tuberculosis Association - The University of Hong Kong Chinese Medicine Centre~     for Training and Research (Aberdeen)~      Participants: 68 subjects with dQt~      Treatment:~      According to the theory of Sinew Acupuncture, acupoints are chosen based on 3 criteria, 1.~     the tender spots, 2.the spots which induce relief of symptoms and 3.the knots (elevated~     spots of the soft tissues, can be located by Chinese Medicine Practitioner (CMP) with Sinew~     Acupuncture training), these spots should locate along the Jing-Jin where the diseased spot~     lies, in this case the Jing-Jin of the Lung meridian and the Large Intestine meridian.~     Acupoints chosen for Sinew Acupuncture should lie within the forearm area. Subcutaneous~     acupuncture with the needle tips pointing towards the radial styloid activates the Wei-Qi~     to achieve analgesic effect and to promote healing.~      Measures:~      Primary outcome: change of Visual Analogue Scale (VAS) score in the 5th treatment (week 2)~     from baseline.~      secondary outcome: Q-DASH (Quick Disabilities of the Arm, Shoulder, and Hand), WHOQOL-BREF~     Quality of Life Questionnaire, pinch strength, grip strength and averse events.~      Data analysis:~      The scores of VAS and Q-DASH at different time points are reported as means ± standard~     deviation. The scores are analysed by the intent-to-treat analysis. The last observation~     carried forward analyses will be employed for missing value. The difference between two~     groups at a time point or the difference between the two time-points in a group is tested by~     the student t-test. The level of the statistical significance is set P<0.05. Subgroup~     analysis and multiple regression analysis will be conducted to eliminate the possible bias~     due to the length of waiting time, the use NSAIDs, or other factor.~   "
7214|NCT03472430|"~     This randomized double-blinded control trial aims to compare the pain levels experienced by~     the women using the standard conscious sedation and those who had transcutaneous electrical~     nerve stimulation (TENS) in addition to conscious sedation. The hypothesis is that there will~     be less pain in women with both conscious sedation and TENS.~   "
7215|NCT03472417|"~     A study to test the efficacy of a partial rebreathing device in treating and/or preventing~     migraine pain~   "
7216|NCT03472404|"~     This study evaluates the effect of internal bracing in lateral ligament ankle surgery. Half~     of the patients will receive the standard Brostrom-Gould reconstruction followed by a~     standard revalidation protocol including 6 weeks of immobilisation, while the other half of~     the patients will receive the same operation augmented with internal brace followed by an~     accelerated rehabilitation protocol.~   "
7217|NCT03472391|"~     In-patients with severe anorexia nervosa (AN) often drop out of treatment, because of~     ambivalence towards treatment and anxiety for weight gain. However, physical therapy has~     shown some positive effects on symptoms of AN. This study aims to investigate the feasibility~     of a randomized control trial (RCT) of a standardized physiotherapeutic program for patients~     with severe AN with compliance to nutritional therapy as the primary outcome measure.~   "
7218|NCT03472378|"~     The majority of migraineurs seeking secondary or tertiary medical care develop cutaneous~     allodynia during the course of migraine, a sensory abnormality mediated by sensitization of~     central trigeminovascular neurons in the spinal trigeminal nucleus. Triptan therapy can~     render allodynic migraineurs pain-free within a narrow window of time (20-120 min) that opens~     with the onset of pain and closes with the establishment of central sensitization. This calls~     for the development of drugs that can tackle ongoing central sensitization and render~     allodynic migraineurs pain-free after the window for triptan therapy has expired. There are~     two main objectives the investigators seek to achieve from this study: to determine whether~     oral administration of DFN-15 (solution of a COX2 inhibitor, Celecoxib) terminates migraine~     attacks when given to allodynic participants 3 hours after attack onset; and to determine~     whether mechanical and heat allodynia that develop during acute migraine attacks could be~     reversed by late (> 3hrs after attack onset) treatment with DFN-15. Participants will be~     recruited from the Headache Center and randomized in a double-blinded fashion to receive~     either the active drug (DFN-15) or placebo in a ratio of 4:1.The participants will be~     instructed to return to the clinic during a migraine. At the 'during-migraine' visit, which~     will begin 3 hours after onset of headache, the investigators will document headache~     intensity, associated symptoms, and mechanical and heat pain threshold (first) before~     treatment (at 180 min after onset of headache) and (second) at a 120 min after treatment (5~     hours after headache onset). Based on our prior experience studying migraine patients, the~     investigators plan to screen 100 patients to achieve 50 participants completing the 2 study~     visits as planned. The active drug group will consist of 80/100 patients and 20/100 patients~     will receive the placebo. The study will be terminated as soon as the first 40 participants~     who received the DFN-15 and first 10 patients who received placebo completed visit 2.~   "
7219|NCT03472365|"~     The purpose of this trial is to estimate overall response rate (ORR) of SHR-1210 combined~     with capecitabine and oxaliplatin or with apatinib as first-line treatment in subjects with~     locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.~   "
7220|NCT03472352|"~     This is an open-label study to evaluate the safety and efficacy of an anticancer medication~     (A01) with immune cells (IC01) in subjects with advanced solid tumors.~   "
7221|NCT03472339|"~     NSAIDs are commonly used in the management of acute pain; Diclofenac is one from the same~     class. It is an amino phenyl acetic acid derivative which inhibits prostaglandin biosynthesis~     to produce analgesic, antipyretic and anti-inflammatory effect. The drug efficacy and safety~     in acute pain management has been proved by several studies like in renal colic, post and~     pre-operative pain management, migraines etc. It's also known to have an opioid-sparing~     effect. Mode of administration is one of the important factors to consider in a busy~     emergency room. Perception about the route of administration differs among patients. As~     believed,injectable have rapid onset, easier to titrate, and patients respond better to them~     as they consider them stronger than oral medication. Number of trials has compared oral and~     parenteral NSAIDs. Most found no benefit to the parenteral route. Considering the limitations~     of the previously done studies like small sample size, heterogeneity in the group of patients~     enrolled, improper blinding and comparing of two different drugs from the same class.~     Therefore, aim of the study is to conduct a Double blind randomized clinical trial to assess~     the clinical efficacy and pharmacokinetic parameters of oral diclofenac compared to~     intramuscular diclofenac in patients with acute limb injury.~      In this two group double blind randomized clinical trial, the clinical efficacy and~     pharmacokinetic parameters among the two groups will be assessed. Eligible patients visiting~     to HGH-ED, age (above 18 years) with acute limb injury, having moderate to severe pain~     (defined as pain score of >=4 on Numerical rating scale) will be recruited. With the use of~     computer generated block randomization, subjects will be allocated to one of the two~     treatment groups in the ratio of 1:1. Each group will receive either (intramuscular~     diclofenac / oral placebo) or (oral diclofenac / intramuscular placebo). Among the 300~     subjects enrolled for the study, further stratified randomization will be done in order to~     enroll 20 patients for pharmacokinetic study within the subjects.High-performance liquid~     chromatography, method will be used for the determination of drug concentration in human~     plasma, for detailed pharmacokinetics. The pain score will be assessed by using the validated~     pain scale i.e. Numerical rating scale (NRS). The participants, clinicians and investigators~     will be masked to treatment assigned and the results will be analyzed by the intention to~     treat analysis among the two group treatment.~   "
7222|NCT03472326|"~     The primary objective of this study is to evaluate the short-term antiviral potency of a~     regimen containing GS-9131 at 30 mg, 60 mg, and 90 mg, compared to placebo-to-match (PTM)~     GS-9131, each administered once daily with the existing failing antiretroviral therapy (ART)~     regimen.~      This is a two-part study. Part 1 consists of two cohorts: a Sentinel Cohort followed by a~     Randomized Cohort. Eligible participants from Part 1 will proceed to Part 2 followed by an~     optional open-label extension.~   "
7223|NCT03472313|"~     The overall goal of this protocol is to evaluate the biodistribution of [18F]MNI-958 also~     known as APN-0000455 or PM-PBB3, as a tau targeted radiopharmaceutical.~   "
7224|NCT03472300|"~     Although knee pain is prevalent among community-dwelling older adults, little is known about~     how people in general handle their pain. We will conduct a survey to explore how knee pain~     affects people's lives and which treatments or self-management strategies they have chosen~     (or are being offered), and how these interact concerning pain reduction and maintenance of~     function.~   "
7225|NCT03472287|"~     The study is designed as an open label, single period study in approximately 16-20 patients~     with EB ranging in age from infants/children (ages 6 months - 11 years, inclusive) and~     adolescents/adults (ages 12 and up) with at least 8-10 subjects between the aged 6 months to~     11 years, inclusive (infants/children). Note: US sites will only enroll patients ages 4 and~     up. The study is 10 days total and will consist of serial PK blood sampling on Days 1 and 10.~   "
7226|NCT03472274|"~     In the treatment of localized/locally advanced urothelial cancer, there are several questions~     that have not yet been resolved, such as the limited benefit of cisplatin-based chemotherapy~     in the adjuvant or neoadjuvant context, the difficulty in establishing which groups actually~     benefit from either perioperative treatment and what are the molecular markers that could~     help us predict the response to this treatment to allow a better selection of patients. On~     the other hand, not all patients are candidates for cisplatin-based chemotherapy and~     carboplatin is not comparable in activity, so there is an urgent need to find other drugs~     that may offer a therapeutic opportunity to these patients.~      In the context of metastatic disease, immunotherapy has been able to modify the natural~     history of this disease, administered as monotherapy, but the combination with double immune~     checkpoint inhibitors is also being evaluated with promising results. Even this therapeutic~     strategy is being advanced to the context of adjuvant and neoadjuvant treatment of urothelial~     tumors. In this sense, on the one hand, the present study, as a research in the neoadjuvant~     setting, constitutes the opportunity to define molecular phenotypes in bladder cancer since~     the design of this study will allow both, to evaluate the efficacy of the drug when the tumor~     is operable and to carry out an extensive analysis of biomarkers in the tumor tissue of these~     patients with an in-vivo evaluation of immune-based therapy activity. On the other hand, it~     allows to evaluate a strategy of double-immune checkpoint inhibitors that has already~     demonstrated activity in metastatic disease and, taking into account, the modest benefit of~     standard chemotherapy in the perioperative context: platinum-based neoadjuvant chemotherapy~     in patients with muscle-invasive bladder cancer (MIBC) Modest increase in overall survival,~     but only a subset of eligible patients are eligible to receive it. In addition, radical~     cystectomy alone, in MIBC patients, presents a 5-year relapse rate of 10-50%.~   "
7227|NCT03472261|"~     Pronation deformity is a very common problem in children with cerebral palsy. This deformity~     is usually has neural and non-neural aspects. In this clinical trial the aim is to show the~     importance of combine treatment approach with pharmacological and non-pharmacological~     modalities. .~   "
7228|NCT03472248|"~     Intervention study with uncontrolled design investigating the effects of smartphone delivered~     Acceptance and Commitment Therapy for longstanding pain in adolescents. Primary outcome is~     pain interference. Internet-based parental support will be offered to the adolescents'~     caregivers.~   "
7299|NCT03471312|"~     The aim of this study is to study the therapeutic and adverse effects of oral magnesium~     sulfate therapy on constipation in children with spastic cerebral palsy suffering from~     chronic constipation in neuro pediatric unit at Assiut University Hospital.~   "
7229|NCT03472235|"~     Melasma is an acquired disorder of hyperpigmentation characterised by blotchy, light-to-dark~     brown macules distributed symmetrically on the sun-exposed parts of the body.~      Although many factors have been proposed to have a role in pathogenesis, the exact ethology~     is yet to be understood. The most commonly identifiable risk factors include ultraviolet~     radiation, genetic predisposition, pregnancy, oral contraceptives, thyroid disease and drugs~     like antiepileptic. The excessive pigmentation has been attributed to both melanocytosis~     (increased number of melanocytes) as well as melano genesis (excess production of melanin) as~     confirmed in a histopathological study on Asian patients.] Furthermore, a vascular component~     has also been proposed to play a role in the pathogenesis of melisma. Kim et al. have found~     that lesion melasma skin had greater expression of the vascular endothelial growth factor in~     keratinocytes compared to nearby nonlesional skin.~   "
7230|NCT03472222|"~     Substance abuse remain critical problems in both developed and developing countries. Under~     privileged communities where health and economic system is weakest, use of drugs and illicit~     substances starts during adolescence and young adulthood. This not just affect physical~     development, mental health and social integration, but also family formation and stability,~     deviant behaviour, sexual behaviour and involvement, educational pursuits, livelihood~     pursuits. Therefore, emphasises the need for preventive education at this impressionable age.~   "
7231|NCT03472209|"~     We aimed to evaluate the different ETCO2 levels (with the help of ultrasonographic optic~     nerve sheath diameter) in preventing gynecological laparoscopic surgeons' postoperative~     nausea induced by intracranial pressure change due to pneumoperitoneum and trandelenburg~     position.~   "
7232|NCT03472196|"~     This is first-in-man safety and performance feasibility study, aimed to provide initial~     clinical assessment of safety and effectiveness of the EndoZip in the treatment of obesity.~   "
7233|NCT03472183|"~     The close homology between the central and enteric nervous system suggests that a disease~     process affecting the central nervous system could also involve its enteric counterpart. This~     has already been demonstrated for patients with Parkinson's disease but needs to be proven~     for Alzheimer's disease. Studies on enteric nervous system during Alzheimer's disease are~     indeed in low number and don't have led to definite conclusion. The investigators thus~     propose to realize a complete analysis of the enteric nervous systems in Alzheimer's disease~     by studying the presence of tau' protein, of beta-amyloid peptide,...~      not only by immunohistochemical but also by a biochemical approach. This study will be~     realized from colonic samples.~   "
7234|NCT03472170|"~     To evaluate the efficacy of enteral administration of bovine lactoferrin (bLf) in the~     reduction of probable late sepsis or microbiologically proven in preterm infants with birth~     weight ≤ 1500 gr and / or gestational age ≤ 32 weeks.~   "
7235|NCT03472157|"~     The aim of the study is to demonstrate the superiority of bariatric surgery on the~     disappearance of NASH without worsening of fibrosis in comparison to medical standard~     treatment in obese patients (35 kg/m² > BMI ≥ 30 kg/m²) with NASH complicated of advanced~     fibrosis (F3 and F4 fibrosis grade according to Brunt score).~   "
7236|NCT03472144|"~     To assess the efficacy of intra-sinus installation of a poloxamer gel that releases~     antibiotics and corticosteroids topically after balloon sinuplasty in chronic sinusitis~     patients with or without polyps. This is a single-blinded Randomized Control Trial study, in~     which every patient receives active gel on one side and placebo on the other (L or R to be~     randomly selected).~   "
7237|NCT03472131|"~     This retrospective study assess the efficacy and safety of a posterolateral unilateral~     approach for debridement and titanium cage insertion supplemented by contralateral~     transfascial screw fixation for sick patients suffering from septic thoracolumbosacral~     spondylodiskitis. Hematogenous pyogenic spondylodiskitis requires surgical intervention in~     cases of development of neurological signs, spinal instability, progressive spinal deformity~     and abscess. When operative treatment is indicated, an anterior approach by open thoracotomy~     or by a thoraco-abdominal approach or combined anterior and posterior approaches are~     recommended. In cases of severe sick patients anterior approach is associated with high~     morbidity and mortality.~   "
7238|NCT03472118|"~     Patients undergoing suspension laryngoscopy under general anaesthesia have oxygen delivered~     to their lungs through different methods. Inserting a tube in the trachea is the best means~     for oxygen delivery. However, it does not allow for optimal visibility of the operated area.~     Other techniques can be used but have disadvantages with some being associated with serious~     complications. No consensus exists regarding the best airway management technique for this~     intervention.~      The aim of the study is to investigate a new device that delivers oxygen at very high flow~     through a nasal cannula in patients undergoing suspension laryngoscopy under general~     anaesthesia. This technique allows the surgeon to have a perfect visualisation of the~     laryngeal structures while allowing the delivery of oxygen for the lungs.~      After informed consent, adult patients undergoing suspension laryngoscopy under general~     anaesthesia in two French hospitals will receive high flow oxygen throughout the procedure.~     At the end of surgery or, whenever applicable, at the time of technique failure (with a~     decrease in blood oxygen saturation to less than 92%), blood will be drawn for analysis. All~     patients will have a thin security catheter inserted in their trachea (the currently used~     technique in both participating hospitals), allowing for rescue high frequency ventilation if~     ever the study technique fails.~      The safety of the device will also be assessed by analysing the blood samples for signs of~     carbon dioxide accumulation and by collecting any intra or post-operative complications.~      If the device shows to be effective at maintaining blood oxygenation without significant~     associated risks, it could be used for other surgical situations where airway management is~     expected to be difficult.~   "
7239|NCT03472105|"~     Hyperphosphatemia is a severe complication to chronic kidney disease (CKD) and is associated~     with increased risk of vascular calcification, cardiovascular morbidity and mortality. Early~     dietary intervention and improvement in dietary therapy might optimally reduce cardiovascular~     complications. For this purpose we have investigated patients with CKD stage 3-4, their~     dietary habits, developed a New Nordic Renal Diet and investigated the short term effect on~     phosphorus homeostasis.~   "
7240|NCT03472092|"~     This study evaluates whether cognitive behavioral therapy (CBT) is more effective in engaging~     and changing brain mechanisms associated with predicting a reduction in headaches than pill~     based therapies (placebo or amitriptyline).~   "
7241|NCT03472079|"~     Patients with septic shock in the intensive care unit have a high risk to develop acute~     kidney injury (AKI) and AKI is an independent risk factor of mortality. Given the absence of~     validated pharmacological treatments for limiting the progression of AKI or for accelerating~     recovery from AKI, early intervention and the restoration of the glomerular filtration rate~     (GFR) in this context of septic shock might improve the patients' prognosis. One major~     challenge is to determine whether or not the AKI is reversible (return to normal function~     KDIGO 0 within 72 hours). In this retrospective study the investigators will analyze all~     patients admitted for a septic shock in three French ICUs between the 1st january 2014 and~     01st January 2017 who developed an AKI (KDIGO ≥1) at admission and who had a determination of~     the urine concentration of TIMP2*IGFBP7 at admission. The investigators will determine the~     best threshold of TIMP2*IGFBP7 to distinguish the population of patients who will return to~     normal kidney function within 72 hours (KDIGO 0).~   "
7242|NCT03472066|"~     Treatment of precancerous lesions of the cervix by conization has been shown to increase the~     risk of premature delivery and premature rupture of the membranes. It has now been clearly~     established that the cervix is a growing organ during adolescence and early adulthood, It has~     been hypothetized that cervical conization during the growth phase reduced its growth~     potential, and induced shorter cervix during the upcoming pregnancy. No studies have been~     conducted investigating the age at which conization no longer had an impact on cervical size~     during pregnancy. This will help to identify the age at conisation below which patients will~     be identified as being at risk event, and thus offer increased monitoring and possibly~     prophylactic management by programmed strapping. We propose to measure the length of the~     cervix of pregnant patients who have benefited from conization, which is currently~     recommended by the Collège National des Gynécologues Obstetriciens Français .In addition, the~     investigators will use a control group consisting of non-con conical, parity-matched pregnant~     patients in whom a cervical measurement will also be performed.~   "
7243|NCT03472053|"~     This Phase 2 is a randomized study in advanced Non-Small Cell lung cancer patients to~     evaluate safety and efficacy of aerosolized BIO-11006 in conjunction with chemotherapy.~   "
7244|NCT03472040|"~     This is an open-label study to evaluate the long term safety and effectiveness of oral~     treatment with BCX7353 in preventing acute angioedema attacks in patients with Type I and~     Type II HAE.~   "
7245|NCT03472027|"~     A Multicenter Open-Label Single-Arm Multi-Cohort Phase I Study of Pharmacokinetics,~     Pharmacodynamics, Safety, and Immunogenicity of BCD-145 (JSC BIOCAD, Russia) Monotherapy in~     Patients with Unresectable/Metastatic Melanoma.~   "
7246|NCT03472014|"~     Prophylactic smallpox vaccination for personnel actively working with or in the vicinity of~     replicating vaccinia virus~   "
7247|NCT03472001|"~     Medical students' abilities to diagnose skin lesions after dermatology electives often remain~     unsatisfactory despite a dermatology elective being one of the most effective ways to improve~     their clinical reasoning. Feedback and reflection are two basic teaching methods used in~     clinical settings. This study aimed to investigate the effectiveness of structured reflection~     and immediate feedback in improving of medical students' evaluation of skin lesions.~   "
7248|NCT03471988|"~     The objective of this study is to investigate the safety and efficacy of administering 372.6~     mg of AK1820 (isavuconazonium sulfate) intravenously or orally to adult Japanese patients~     with deep mycosis. The primary endpoint is safety (percentage of patients with adverse events~     after starting the study treatment).~   "
7249|NCT03471975|"~     prospective randomised trial to compare the teaching effect for tracheal intubation following~     training with McGrath video laryngoscope as direct laryngoscope versus training with McGrath~     video laryngoscope as video laryngoscope~   "
7250|NCT03471962|"~     Indirect respiratory quotient (RQ) measurement involves indirect calorimetry, which measures~     O2 and CO2 inspired and expired fractions. This measurement is usually used to estimate~     energy expenditure and which energetic substrate is preferentially used in resuscitation~     patients. Cohen et al. demonstrated in a mouse model that the formation of hemorrhagic shock~     was associated with a change in RQ due to VCO2 and VO2 imbalance. RQ was able to distinguish~     anaerobic metabolism and corrected itself with correction of shock. Recently in a letter,~     Danin et al showed a link between lactate production, cardiac output and the evolution of the~     RQ measured by indirect calorimetry in a resuscitation patient. Also, these authors raise the~     question of a possible use of the RQ in intensive care as an early non-invasive marker of~     anaerobic metabolism that can replace the invasive ones usually used (arterial lactate,~     venoarterial PCO2 gradient, venoarterial PCO2 gradient/ arteriovenous O2 content difference,~     ScVO2). However, the measurement of inspired and expired fractions in O2 and CO2 is part of~     the systematic monitoring of the intubated-ventilated patient in the operating room. The~     measurement of the VO2, VCO2 and the RQ could therefore be done from these fractions inspired~     and expired in O2 and CO2 by the following equation:~      RQ = (FeCO2-FiCO2) / (FiO2-FeO2) The main objective of our work is to demonstrate the ability~     of the RQ, measured indirectly from the anesthesia ventilator, to predict the occurrence of~     anaerobic metabolism in patients operated of major non-cardiac surgical operation in the~     operating room. Secondly, the objective is to evaluate the association between the variations~     of the RQ, EtCO2, Dc, ScVO2, venoarterial PCO2 gradient, venoarterial PCO2~     gradient/arteriovenous O2 content difference and lactate levels at different times during the~     surgical procedure and depending on the occurrence of postoperative complications.~   "
7251|NCT03471949|"~     The purpose of this study was to obtain reference values of CGM in healthy individuals using~     the Dexcom G4 sensor and evaluate whether reported low glucose values by the Dexcom G4 sensor~     are really low when confirmed by capillary testing.~   "
7252|NCT03471936|"~     The aim of the study is to assess the characteristics, incidence and predictors of~     load-independent right ventricle (RV) diastolic dysfunction in patients with congenital heart~     disease (CHD) and adverse RV loading conditions by acquiring pressure-volume loops and~     compare these results to a population of patients with exclusion of coronary artery disease~     and absence of any known disease affecting the RV.~   "
7253|NCT03471923|"~     This study will examine the prevalence of four previously identified non-motor markers in a~     population of cervical dystonia patients, unaffected family members, and healthy volunteers~     in an attempt to identify a distinct combination of non-motor symptoms that may be indicative~     of disease development.~   "
7254|NCT03471910|"~     Clinical non-inferiority study between Diosmin 600 mg tablets and Diosmin 900 mg + Hesperidin~     100 mg tablets in symptomatic chronic venous insufficiency after 6 months of treatment.~     Prospective, single-blind, randomized study in parallel groups (total patient population 120,~     60 subjects per treatment group), with a total of 4 clinical assessment at months 0, 2, 4,~     and 6 of treatment.~   "
7300|NCT03471299|"~     This study assesses retrospectively the association of mortality on UFR assessments in our~     study population undergoing HD.~   "
7302|NCT03471273|"~     Comparison of Endoscopic and Laparoscopic Resection for Small Gastric Gastrointestinal~     Stromal Tumor~   "
7255|NCT03471897|"~     In this study, the investigators profiled plasma glycosaminoglycans (GAGs) in a retrospective~     consecutive series of patients with a radiographic finding of renal mass referred to primary~     surgery for renal cell carcinoma (RCC). A control group was formed by measuring plasma GAGs~     in healthy volunteers. The primary endpoints were the specificity and sensitivity of plasma~     GAGs in the detection of early stage RCC in pre-surgical samples versus healthy individuals.~     The investigators further analyzed how plasma GAGs varied according to stage, grade, RCC~     histology, other renal masses, and after surgery. Finally, the investigators estimated~     whether plasma GAGs could be used for prediction and surveillance of RCC recurrence.~   "
7256|NCT03471884|"~     A novel nonintubated thoracoscopic technique is promising to enhance recovery after thoracic~     surgery. However, the effects of nonintubated technique on specific organ protection in not~     clear yet. In this randomized trial, the effect of nonintubated technique on lung function~     protection will be evaluated via PaO2/FiO2 ratio, oxidative stress and inflammatory cytokines~     serially in lung cancer patients undergoing thoracoscopic lobectomy.~   "
7257|NCT03471871|"~     This study will be conducted to determine whether lemborexant as compared to placebo~     decreases the peripheral oxygen saturation during total sleep time in healthy adult and~     elderly participants after a single dose of treatment and to determine whether it increases~     the apnea-hypopnea index after single and multiple doses of treatment in adult and elderly~     participants with mild Obstructive Sleep Apnea.~   "
7258|NCT03471858|"~     To determine if mechanical labour induction can offer a safer and effective alternative to~     prostaglandins to women with previous caesarean section attempting trial of labour after~     caesarean (TOLAC).~   "
7259|NCT03471845|"~     It is a single arm clinical evaluation of safety and efficacy of the Medtronic Resolute Onyx™~     zotarolimus-eluting coronary stent system in subjects who are eligible for percutaneous~     transluminal coronary angioplasty (PTCA) in de novo lesions amenable to treatment with~     Resolute Onyx™ Stent System in China.~   "
7260|NCT03471819|"~     Atopic dermatitis (AD) is a chronic pruritic inflammatory skin disease of unknown aetiology.~     Global prevalence rates range from 1%-20%.AD is often worsened by stress and anxiety.Plasma~     levels of 5-HT were found to be positively correlated with the disease severity.~   "
7261|NCT03471806|"~     This study will assess the role of dopamine responses to food reward in Bulimia Nervosa~     patients, by performing simultaneous Positron Emission Tomography (PET) and Magnetic~     Resonance (MR) scanning. The dopamine response will be measured before and after treatment,~     and will be compared to healthy controls.~   "
7262|NCT03471793|"~     A prospective, multicentre, observational study of all patients referred for endoscopic~     resection of sessile colorectal polyps sized ≥20 mm conducted with intention to treat~     analysis~   "
7263|NCT03471780|"~     Assessment of progress of labour is an important step in decision making of obstetricians~   "
7264|NCT03471767|"~     This research study is designed with the purpose of evaluating a new drug, combination~     Dextromethorphan-Bupropion (AXS-05), for its effects on smoking behavior.~   "
7265|NCT03471754|"~     This pilot study uses TESA-HB therapy for treatment of depressive symptoms associated with~     mild and moderate depression episodes. Primary objectives of this pilot study are to~     demonstrate the safety of TESA-HB Therapy, and to investigate the efficacy of TESA-HB Therapy~     for depressive symptoms.~   "
7266|NCT03471741|"~     To assess feasibility of postoperative IMRT with concomitant boost in moderate-high risk~     breast cancer in terms of late toxicity and local control~   "
7267|NCT03471728|"~     The objective of this study is to evaluate the long-term safety and efficacy of linaclotide~     in post-marketing use.~   "
7268|NCT03471715|"~     observational crosssectional study to evaluate the Frequency of Root Fenestration and~     Dehiscence at Different Teeth Types in a Sample of Adult Egyptian Population Using Cone Beam~     Computed Tomography.~   "
7269|NCT03471702|"~     Aqueduct's Smart External Drain (SED) will be compared to the current gold standard for~     temporary CSF management in a hospital setting.~        -  Evaluate the number of subjects requiring to be switched to a standard of care EVD~        -  Evaluate subject transport while on the SED~        -  Evaluate SED system control from initiation of SED through discharge of external drain~          system~   "
7270|NCT03471689|"~     Pain is a predominant disruption of well-being among humans. Feeling pain is a multimodal~     sensory experience where information is collected and processed from various senses such as~     sight and touch. Because pain is complex, variable, and experienced differently by each~     individual, finding more accessible and practical treatments for pain are necessary.~     Mindfulness meditation (MM) aims to reduce pain by directing focus to perceive thoughts~     through non-judgmental awareness. Positive reappraisal (PR) is a possible cognitive pain~     treatment that focuses on changing the meaning of stressful or negative events into positive,~     benign, valuable, or beneficial. When a stressful event, such as experiencing pain, is~     positively reappraised, the individual recognizes and engages with the feeling of stress~     produced by the event and intentionally looks for benefits that change the feeling from~     negative to positive. The focus of this study is to examine the effect of different cognitive~     techniques on multimodal innocuous and noxious stimuli. Visual and tactile noxious stimuli~     will be administered to determine how visual cue integrate to form and modulate the~     subjective experience of pain. The study team postulates that mindfulness meditation and~     positive reappraisal will significantly reduce pain in response to multimodal stimulus~     (visual cue + noxious heat) when compared to a non-manipulation control condition. These~     findings will be utilized to better understand the multidimensional mechanisms supporting~     nociception and the cognitive modulation of pain.~   "
7271|NCT03471676|"~     Preliminary data underline the fact that muscular deoxygenation during training happens~     earlier in adult patients suffering from neuromuscular disorders in comparison to controls.~     Up to date, pediatric data are lacking.~      The study aims at demonstrating if a correlation exists between the motor deficiency and the~     muscular deoxygenation in children suffering from neuromuscular disorders.~   "
7272|NCT03471663|"~     This is a phase I, open-label study of D-0502 single agent and D-0502 in combination with~     standard dose of palbociclib to assess the safety and tolerability, identify an MTD, and/or~     RP2D, evaluate the PK properties and evaluate preliminary anti-tumor activities in women with~     advanced or metastatic ER-positive, HER2-negative breast cancer.~   "
7277|NCT03471598|"~     Impaired motor function is common after stroke. Individuals with stroke often exhibit~     synergic pattern that disturb daily function. It is crucial to identify the movement~     impairment in the clinical settings. Upright Motor Control Test (UMCT) is one of the tests~     developed to assess the selective movement control and functional strength in people with~     central nervous disorders. It can be used to reflect the impairment of motor function and~     evaluate changes of performance after treatment. Yet is little to know the clinimetrics of~     the UMCT on clinical utility. To date, only few researches explore that UMCT has some~     construct and criterion validity.~      Therefore, this study aims to 1) establish the inter-rater reliability to administer the~     UMCT. 2) explore the correlation between the Fugl-Meyer Assessment of Motor Recovery after~     Stroke (FMA) and UMCT. 3). investigate whether the UMCT is able to predict the walking~     ability in patients with stroke.~   "
7278|NCT03471585|"~     The purpose of this study was to examine the effects of THC on the retrieval of emotional and~     neutral memories in healthy young adults.~   "
7279|NCT03471572|"~     This is a non-interventional, cross-sectional, multicentre, observational study planned to be~     conducted at 15 sites across all geographical regions of India. The study targets to enrol~     240 patients with approximately 16 patients from each site. Written approval of Independent~     Ethics Committee (IEC)/ Institutional Review Board (IRB) and written informed consent from~     willing patients will be obtained prior to the start of the study.~   "
7280|NCT03471559|"~     Basic characterization of the drug delivery system for cannabidiol. A comparative~     bioavailability study.~   "
7281|NCT03471546|"~     The purpose of this research study is to determine the feasibility and acceptability of~     incorporating palliative care into the clinical care plans of patients newly diagnosed with~     malignant brain tumors. Palliative Care is a field of medicine that focuses on providing~     relief from symptoms and stress related to serious illnesses. This study will assess the~     feasibility of conducting a future study, and will gather data upon which to appropriately~     tailor the intervention and the future study design. The statistical analysis of this study~     will describe 8 components that encompass each of the 4 areas of focus or domains:~     acceptability, demand, implementation, and integration.~   "
7282|NCT03471533|"~     Randomized controlled trial with two parallel branches (experimental product and placebo),~     double blind and unicentric with which it is intended to evaluate the efficacy of the product~     under investigation against placebo on blood pressure of normotensive subjects or with~     hypertension grade I without Pharmacotherapy. The subjects that meet the selection criteria~     will make a total of five visits to the research laboratory and perform the tests that were~     pre-established in the protocol. Later, a statistical analysis will be carried out with the~     variables measured in the study to obtain results.~   "
7283|NCT03471520|"~     There has been some recent evidence to support the use of earplugs and eye masks to prevent~     delirium, but the existing studies have been small, have not been thoroughly replicated, and~     have only been conducted with intensive care unit (ICU) patients. Therefore, we propose to~     conduct a single-arm pilot study for an eventual single-blinded randomized controlled trial~     designed to assess the efficacy of earplugs and eye masks worn at night for prevention of~     delirium in a population of general medicine inpatients over the age of 65. The primary~     outcome will be incidence of delirium as measured by Confusion Assessment Method (CAM). In~     this pilot study, we will assess feasibility and will not perform any statistical~     comparisons. In the subsequent randomized controlled trial, we will be comparing the hazard~     rates on an intention-to-treat basis. Secondary outcomes will be exploratory and include~     length of stay, cost data, and use of pharmacologic interventions for sleep, delirium, or~     agitation. There are no physical risks and no cost to the subjects in this study.~   "
7284|NCT03471507|"~     This study is a non-inferiority study comparing efficacy and onset of action between the~     herbal extracts topical solution, Bonipar, and diclofenac sodium topical solution, diclofenac~     gel 1%.~   "
7285|NCT03471494|"~     Aim The aim is to determine the variation in quality of cancer surgery worldwide. Quality~     will be determined using measures covering infrastructure, care processes, and outcomes. The~     study will concentrate on the most common surgically treated cancers worldwide: breast,~     gastric and colorectal cancer. The primary aim focusses on 30-day mortality and complication~     rates after cancer surgery. The secondary aim is to characterise infrastructure and care~     processes in the treatment of these cancers worldwide.~      Primary outcome measure 30-day mortality and complication rates after cancer surgery.~      Primary comparison Between country groups defined by human development index.~      Hospital eligibility Any hospital in the world performing surgery for breast, gastric or~     colorectal cancer.~      Patient eligibility Consecutive patients undergoing surgery for breast, gastric, or~     colorectal cancer. Surgery can be with palliative or curative intent.~      Team Individual hospital teams with up to three people, collecting data for four weeks.~     Several teams collecting data over multiple four-week periods is encouraged.~      Time period Patients will be identified, and data collected on all patients during the~     time-period with follow-up to 30-days. The study will run from 1st April 2018 to 31st October~     2018 (with follow-up of the last period to 30th November 2018).~      Validation Data validation will be in two parts. First, centres will self-report the key~     processes used to identify and follow-up patients. Second, independent validators will~     quantitatively report case ascertainment and sampled data accuracy.~   "
7286|NCT03471481|"~     The objective of this study is to determine the role of magnesium on bone and vitamin D~     metabolism in patients receiving anti-epileptic medications.~   "
7287|NCT03471468|"~     Microparticles have recently emerged as a thrombotic risk marker with a potential role in~     determining which patients are at greatest risk for developing thrombosis. Available data~     show an increase in the level of microparticles in cancer patients who are undergoing~     chemotherapy for solid tumors with a possible link to their thrombogenic state.~      Our study focuses on the kinetics of microparticles under chemotherapy in patients with~     pancreatic or gastric cancer by serial measurements of microparticles procoagulant activity.~      Detailed Description:~      The impact of chemotherapy on microparticles expression will be assessed by measuring their~     procoagulant activity on blood samples taken during the course of chemotherapy. The~     thrombotic risk will be evaluated by the score of Khorana in parallel. Microparticles~     expression in patients with thrombosis will be compared to that in other patients.~   "
7288|NCT03471455|"~     This study is a prospective, double blinded, randomized, pilot study to assess the~     effectiveness of oral low dose isotretinoin in combination with oral terbinafine and~     itraconazole in preventing recurrences in chronic recurrent dermatophytosis. The recruited~     patients will be randomized into four treatment arms; oral terbinafine alone and oral~     itraconazole alone versus oral isotretinoin in combination with each of these two antifungal~     agents. Randomization will be done using computer generated random number table. The patients~     in first treatment arm will receive 250 mg of oral terbinafine for 4 weeks, the patients in~     second treatment arm will receive oral itraconazole 200 mg twice a day for the same duration,~     while the patients in the third arm will receive oral terbinafine 250 mg once a day for 4~     weeks with oral isotretinoin 20 mg once daily and patients in the fourth arm will receive~     oral itraconazole 200 mg twice a day for 4 weeks with oral isotretinoin 20 mg once daily. In~     the third and fourth arms, oral terbinafine and oral itraconazole respectively will be~     stopped after 4 weeks while oral isotretinoin will be continued for 6 months with monthly~     monitoring of liver function tests and fasting lipid profile.The patients will be followed at~     monthly intervals for recurrence and treated appropriately.~      The primary objective is to evaluate the effectiveness of low dose isotretinoin (20 mg/day)~     in preventing recurrences in chronic recurrent dermatophytosis by comparing the frequencies~     of recurrence in patients who are on low dose isotretinoin during the follow up versus those~     who are not comparing the disease free interval between the four randomized groups at monthly~     follow up for a total duration of 6 months.~   "
7289|NCT03471442|"~     This study aims to compare the effectiveness of paravertebral block and erector spinae plane~     block after mastectomy.~      The primary objective of this randomized controlled trial is to demonstrate equivalent~     dermatomal spread for ultrasound-guided single-injection Erector Spinae Plane (ESP) block~     performed at T4-T5 level and ultrasound-guided single-injection (paravertebral) PVB block at~     the same level.~      Secondary objectives are Numerical Rating Scale (NRS) pain scores in the first 24~     post-operative hours, opioid analgesia use intra-operatively and in the first 24~     post-operative hours, block procedural time and patient discomfort during block insertion.~      The investigators hypothesize that ESP block efficacy is not inferior to PVB with reference~     to dermatomal sensory spread and analgesic efficacy, while being easier to perform with less~     associated discomfort during block insertion.~   "
7290|NCT03471429|"~     The purpose of this study is to see if dogs can reduce the anxiety level of patients in the~     emergency department.~   "
7291|NCT03471416|"~     This study proposes to investigate the association of nutritional status of a children~     assessed by body mass index (BMI), triceps skinfold thickness (TSFT), and mid upper arm~     circumference (MUAC), with body composition, measured by dual-energy X-ray absorptiometry~     (DEXA), in 60 children undergoing treatment of ALL at Unidad Nacional de Oncologia Pediatrica~     (UNOP), in Guatemala City, Guatemala. The study also aims to establish normative values of~     body composition in children residing in an LMIC by examining 160 healthy siblings of~     children under treatment, and to measure habitual physical activity in children with acute~     lymphoblastic leukemia (ALL) at diagnosis and during therapy.~   "
7292|NCT03471403|"~     The purpose of this study is to collect prospective observational data regarding patients~     with diagnosed Familial Adenomatous Polyposis (FAP) undergoing cold snare polypectomy for~     duodenal adenomas~   "
7293|NCT03471390|"~     This study aims to improve pain management in Swiss nursing homes by addressing behavior~     change of the care workers with a multilevel intervention~   "
7294|NCT03471377|"~     The investigators are studying the duration it takes surgeons to complete their respective~     surgical cases. The hospital hopes to improve the overall operating room scheduling accuracy~     from this project.~   "
7295|NCT03471364|"~     This early phase I trial studies the side effects of ketoconazole and how well it works in~     treating participants with ongoing EGFR inhibitor-induced rash. Ketoconazole may reduce the~     symptoms related to EGFR inhibitor therapy and improve EGFR inhibitor-induced rash.~   "
7296|NCT03471351|"~     To characterize safety, tolerability and to establish the maximum tolerated dose (MTD) for~     Tenalisib in combination with Pembrolizumab in patients with cHL.~   "
7297|NCT03471338|"~     Multiple sclerosis (MS) is a central nervous system inflammatory disease that causes a~     chronic and progressive physical handicap. Though primarily considered as a motor disease, it~     may, in 40 to 65% of cases, cause cognitive function deficits, concerning mainly attention,~     information processing speed, executive functions and memory. The impairment of these various~     functions may significantly impair the patients' social, professional and family lives. As~     such, the presence of cognitive difficulties is more frequently associated with the onset of~     anxio-depressive psychiatric symptoms and with reduced quality of life to the extent that it~     can be estimated via psychometric scales, or by a more qualitative approach. Recent research~     has focused, not on demonstrating the existence of cognitive disorders in MS, but rather on~     attempting to reduce their daily impact through cognitive rehabilitation programmes. While~     encouraging, the available results are relatively discordant and further work is required to~     demonstrate the actual efficacy of such programmes applied to daily life and of their~     long-term effects.~      The main objective of this work is to evaluate, in patients suffering from MS and presenting~     with cognitive disorders and/or with complaints, the effect of an innovative computerised,~     semi-autonomous at-home cognitive rehabilitation programme, following care, on quality of~     life. The secondary objective is to estimate the improvement, or even stabilisation over~     time, of patients' cognitive performance and psycho-affective sphere.~      In this randomised trial, the investigators plan to include 40 patients suffering from the RR~     and SP forms of MS, distributed to two groups paired by age, gender and socio-cultural level,~     one of which will benefit from computerised management, along with at-home support from a~     psychologist, while the other receives only the support.~      This work is expected to provide two types of benefits. Firstly, to enable patients to better~     understand their cognitive function via daily management and as such to improve their quality~     of life and self-esteem. Secondly, to eventually allow more appropriate patient management by~     combining the quasi-systematic use of this programme with follow-up consultations with~     referring practitioners (neurologists, psychologists, etc.).~   "
7298|NCT03471325|"~     Background: In most practices, conventional in-office prophylaxis starts immediately with~     scaling and polishing. Therefore, this project was designed to challenge tradition by~     comparing plaque removal efficacy of rubber cup and air polishing in two scenarios, one where~     plaque was disclosed prior to treatment and the other where plaque was not disclosed.~      Methods: In this randomized, single blind, split-mouth design clinical trial, healthy,~     non-smoking participants with poor oral hygiene were recruited. Quadrants in each participant~     were randomly assigned to 4 treatment groups, which were plaque disclosure with rubber cup~     polishing, no plaque disclosure with rubber cup polishing, plaque disclosure with air~     polishing, and no plaque disclosure with air polishing. Examiners were calibrated and masked~     to the treatment rendered in each quadrant. Post treatment satisfaction questionnaires for~     both participants and operators were completed. Plaque scores for each quadrant and treatment~     time were the recorded outcome measures.~   "
7303|NCT03471260|"~     There are 2 parts to this clinical research study: Part 1 (dose escalation) and Part 2 (dose~     expansion).~      The goal of Part 1 of this clinical research study is to find the highest tolerable dose of~     the combination of ivosidenib (AG-120) and venetoclax that can be given to patients with~     relapsed (has come back) or refractory (has not responded to treatment) acute myeloid~     leukemia (AML) with an IDH1 mutation (a type of genetic change).~      The goal of Part 2 is to learn if the highest tolerable dose of ivosidenib and venetoclax~     found in Part 1 can help to control the disease.~      The safety of this drug combination will be studied in both parts.~      This is an investigational study. Ivosidenib is not FDA approved or commercially available.~     Venetoclax is FDA approved and commercially available for the treatment of a certain type of~     chronic lymphocytic leukemia (CLL). It is considered investigational to use ivosidenib in~     combination with venetoclax to treat AML.~      The study doctor can explain how the study drugs are designed to work.~      Up to 48 patients will be enrolled on this study. All will take part at MD Anderson.~   "
7304|NCT03471247|"~     Patients who survive critical illness usually experience long-lasting physical and~     psychological impairments, which are often debilitating. Rehabilitation interventions started~     in the ICU may reduce this morbidity. In-bed cycling, which uses a special bicycle that~     attaches to the hospital bed, allows critically ill patients who are mechanically ventilated~     (MV) to gently exercise their legs while in the ICU. The main goal of this study is to~     determine whether critically ill MV adults recover faster if they receive early in-bed~     cycling than if they do not. Another objective is to determine whether in-bed cycling is a~     cost-effective intervention. 360 patients admitted to the ICU and receiving MV will be~     enrolled in the study. Following informed consent, patients will be randomized to either (1)~     early in-bed cycling and routine physiotherapy or (2) routine physiotherapy alone. Patients'~     strength and physical function will be measured throughout the study. If early in-bed cycling~     during critical illness improves short-term physical and functional outcomes, it could~     accelerate recovery and reduce long-term disability in ICU survivors.~   "
7305|NCT03471234|"~     Prospective, multicenter, single arm registry to monitor post-market clinical outcomes of~     patients treated with Inspiron Sirolimus-Eluting Stent with Biodegradable Polymer.~   "
7306|NCT03471221|"~     This study involves two distinct activities:~      The first is a randomized controlled trial (RCT) to assess the efficacy and safety of therapy~     dog visits for children with cancer. This activity has the following specific objectives:~        1. To assess the effect of therapy dog visits on psychosocial outcomes and satisfaction~          with care among pediatric oncology inpatients.~        2. To determine whether therapy dog visits increase microbial levels on children's hands.~      The Investigators hypothesize that therapy dog visits will reduce patient distress, lower~     treatment-related anxiety, increase happiness, and improve satisfaction with hospital care.~     The Investigators further hypothesize that therapy dog visits (including standard hand~     sanitization) will not increase microbial levels on children's hands.~      Once the main study aims for the first study activity have been completed, the research study~     team will begin recruitment for the second activity. The second activity is an observational~     study to describe microbial levels before a dog visit, after a dog visit but before hand~     cleaning, and after hand cleaning. This phase will provide additional information for Aim 2~     that cannot be obtained during the RCT given the nature of the RCT design. The Investigators~     will proceed with the observational study only if all main study activities can be completed~     within the study timeline.~   "
7307|NCT03471208|"~     Placement of dental implants via the freehand approach may result in damage to the~     surrounding critical anatomy of undiscordant prosthetic position. A real-time navigational~     stereotaxic surgical instrument (navigation) may help to alleviate these undesired outcomes~     in the freehand approach.~      All patients received implants in the right and left the side of their upper jaws via the~     random use of the navigation or the freehand approach. Positional deviations between the~     planned and placed implants were measured on a final tomographic image matched to the~     baseline.~   "
7308|NCT03471195|"~     always reliable.Pain is an important diagnostic tool in dentistry. The type of treatment,~     extent of treatment and, sometimes, even the decision on whether to treat or not is dependent~     on the pain history obtained from the patient.The absence of an accurate description of~     dental pain is a factor that severely limits dental treatment planning in children with CP.~     The aim of this study is to study to evaluate the salivary cytokine profile of children with~     CP who have severe dental problems and to compare this to verbal children who have a similar~     dental profile.~   "
7309|NCT03471182|"~     The proposed research program will investigate the changes in brain chemistry and circuitry~     that 're-wire' the brain during chronic cocaine use, promote relapse, and complicate~     treatment efforts. Currently-using and non-treatment-seeking individuals with a cocaine use~     disorder will undergo a cocaine self-administration paradigm 2-5 days prior to completing~     positron emission tomography (PET) and functional magnetic resonance imaging (fMRI).~   "
7310|NCT03471169|"~     To investigate the therapeutic effect of individualized treatment of antiplatelet in~     secondary prevention of ischemic stroke.~   "
7328|NCT03470935|"~     Brest cancer is the most common cancer in women in France with 52.000 new cases diagnosed in~     2010 including nearly 6.000 women younger than 40.~      The improvement of the fertility conservation of cancer patients is one of the goals put~     forward by the french Cancer Plan (Objective 8.1).~      The issue of fertility after a breast cancer is a frequently raised subjects by the concerned~     couples today. The improvement in prognosis due to therapeutic advances combined with the~     increasing age of the first pregnancy and in the recomposed couples bring number of young~     women between 35 and 40 years followed for breast cancer today to raise these questions with~     their oncologists.~      Young women have a greater risk to develop agressive tumors requiring a mulitimodal treatment~     whose general and gonadic side effects can be important and permanently impact the~     reproductive capacity. At the time of diagnosis, almost 50% of these young patients report~     that they want to consider a later pregnancy but no data are available on the evolution of~     this wish over time although it is known that anti-cancer treatments have a serious impact on~     future possibilities of pregnancy(s).~      The sequential chemotherapy regimen prescribed in adjuvant or neo-adjuvant situation includes~     intercaling agents (antracyclines) and an alkylating agent (cyclophosphamide) partially~     responsible for subsequent fertility disorders. In addition, a chemotherapy-induced~     amenorrhea (CAI) occurs in 50 to 80% of women according to the studies, the latter is~     sometines definitive and sequellar of treatment. However, few data describe the time of~     recovery of menstrual cycles in women with CAI and subsequent impact of fertility.~      The aim of this study is to evaluate the impact of cancer diagnosis and treatment on the~     wishes of fertility before and after the management of cancer of the patients in question, on~     the recovery of menstrual cycles and the quality of sexual life of these patients.~      The investigators hope to improve the pre-therapeutic evaluation of women wishing to~     implement measures to preserve fertility, to assist women wishing to consider this type of~     project after cytotoxic treatments and accompany women suffering from a change in self-image~     that has an impact on their quality of life. These results could help to sensitize the~     doctors to the difficulties encountered by young women and to improve and/or to strengthen~     the global and adapted care of these patients.~   "
7311|NCT03471156|"~     Endoscopic mucosal resection (EMR) of large (≥20 mm) laterally spreading colonic lesions~     (LSL) is safe, effective and superior to surgery. This advantage is based on a day stay model~     of care, however the most common adverse event is abdominal pain and this is a major~     impediment to this efficiency. No prospective data exist on the optimal selection of~     analgesics, the necessary recovery period or the triggers that should alert the practitioner~     to a more serious trajectory and the need for escalation of care.~      We aimed to characterise potential predictors for persistent (>5 minutes) post-procedural~     pain (PP) and develop a simple and effective management algorithm for patients with PP based~     on the need for analgesics in recovery.~      Data on consecutive patients with a LSL referred for EMR at a single, tertiary referral~     centre were included. Patient and lesion characteristics and peri-procedural data were~     prospectively collected. Standard post EMR care included 2 hours in first stage recovery~     followed by 1 hour in 2nd stage recovery where clear fluids were given and discharge after if~     the patients were well. PP was graded from 0 to 10 using a Visual Analogue Scale (VAS). If PP~     occurred >5 minutes, 1 gram of paracetamol was administered parenterally and outcomes were~     monitored. If pain settled the patient was transferred to second stage recovery after medical~     review. PP >30 minutes lead to clinical review and upgrade of analgesics to fentanyl, with a~     starting dose of 25 micrograms (mcg) up to a maximum of 100 mcg. Investigations, admission~     and interventions for PP are recorded.~   "
7312|NCT03471143|"~     Niemann-Pick disease, type C (NPC) is a lethal, autosomal recessive, lysosomal storage~     disorder characterized by neurodegeneration in early childhood and death in adolescence. NPC~     results from mutation of either the Niemann-Pick C1 disease (NPC1) (~95% of cases) or NPC2~     genes. NPC is characterized by the endolysosomal storage of unesterified cholesterol and~     lipids in both the central nervous system and peripheral tissues such as the liver.~     Individuals with NPC demonstrate progressive central nervous system decline including~     inability to coordinate balance, gait, extremity and eye movements. Acute liver disease in~     the newborn/infant period is frequently observed, but subsequently resolves. However,~     chronic, sub-clinical liver disease persists. Intrathecal 2-Hydroxypropyl-β-Cyclodextrin~     (HP-β-CD, VTS-270) has proven effective in reducing the signs and prolonging life in animal~     models and Phase 1/2a data support efficacy in NPC1 patients. VTS-270 also has been shown to~     be effective in treating liver disease in the NPC1 cat.~      This Phase 1/2a, open-label, multiple ascending dose trial will evaluate whether VTS-270~     administered intravenously is effective in treating acute liver disease in NPC1 infants.~   "
7313|NCT03471130|"~     This is a study to definitively assess the effects of MT 8554, adjusted for placebo, on the~     change of the QT interval corrected for heart rate (HR) using the Fridericia formula (QTcF)~     from Baseline in healthy adult subjects~   "
7314|NCT03471117|"~     Chronic kidney disease (CKD) is associated with a higher risk of cardiovascular disease and~     death. An overactive sympathetic nervous system in CKD patients is one of the major~     mechanisms increasing the cardiovascular risks in this patient population. Recently, some~     studies have shown that a drug typically used to improve glucose control (pioglitazone) may~     also reduce sympathetic nerve activity and improve blood vessel function.~      The goal of this study is to determine whether a short-term treatment with pioglitazone can~     reduce sympathetic nerve impulses throughout the body in CKD patients.~   "
7315|NCT03471104|"~     The study aim to evaluate the use of Patient-Reported Outcome Measures in clinical diabetes~     consultations.~   "
7316|NCT03471091|"~     Chronic Obstructive Pulmonary Disease (COPD) is a worldwide common disease with high~     morbidity and mortality and leads to heavy social and economic burden. Health management of~     stable COPD patients has been suggested to be essential for delaying diseases progress,~     reducing acute exacerbation events and improving patient quality of life. Non-invasive~     ventilation (NIV) is a widely used treatment in COPD patients. There were studies shown that~     NIV could improve ventilation, blood gases etc., and several clinical trials have shown~     improvements in survival, exercise capacity, quality of life and so on. Compliance to NIV and~     optimal parameter setting are important factors that will affect the effect of the use of~     NIV, thus NIV usage monitoring might also be a crucial element in the health management of~     COPD patients. Many studies have been designed to study the effect of tele-monitoring program~     on the management of COPD patients. However, almost none of these studies were designed for~     specific population, and little is known about the effect of such program on the management~     of patients with NIV treatment.~   "
7317|NCT03471078|"~     Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and~     safety of avatrombopag in subjects with chemotherapy-induced thrombocytopenia receiving~     chemotherapy for the treatment of ovarian, non-small cell lung and bladder cancer.~   "
7318|NCT03471065|"~     A Prospective, Single-arm, Study of the Edwards Lifesciences SAPIEN 3 Ultra Delivery System~     used with the SAPIEN 3 Ultra THV and SAPIEN 3 THV in Intermediate Risk Patients with Severe,~     Calcific, Aortic Stenosis Requiring Aortic Valve Replacement~   "
7319|NCT03471052|"~     Inlet patch is a congenital condition of the upper oesophagus, consisting of stomach lining~     that is in the wrong place. It affects 5% of the population. Symptoms are a feeling of a ball~     in the back of the throat (called chronic globus sensation), cough and sore throat - these~     account for 4% of general practitioner (GP) referral to Ear Nose & Throat departments.~      There is no recognised treatment. Drugs that reduce acid may help but do not block mucus~     production. Argon Plasma coagulation has been shown to be successful but limited to a few~     expert centres. The investigators have previously shown a device that uses radiofrequency~     energy to remove the patch to be highly effective in a ten patient pilot study, with 80%~     response rate that was durable over 1 year.~      The purpose of this trial is to demonstrate the previous study was not due to placebo effect~     alone, with a sham controlled arm. Patients would then crossover to treatment at 6 months~     after sham. All males and non-pregnant females over 18 years old with previously diagnosed~     inlet patch causing symptoms of globus, with > 50% severity on a visual analogue score, are~     eligible.~   "
7320|NCT03471039|"~     Pituitary adenylate cyclase-activating polypeptide (PACAP) is a signaling molecule, localized~     in sensory and parasympathetic perivascular nerves fibres. PACAP exists i to functional~     iso-forms Pituitary adenylate cyclase-activating polypeptide-38 (PACAP38) and PACAP27.~   "
7329|NCT03470922|"~     The purpose of this study is to determine whether Nivolumab in combination with Relatlimab is~     more effective than Nivolumab by itself in treating unresectable Melanoma or Melanoma that~     has spread~   "
7321|NCT03471026|"~     Post-operative paediatric cerebellar mutism syndrome (pCMS) is a well-recognised complication~     of resective surgery for brain tumours of the cerebellum and fourth ventricle in children.~     Occurring in around 25% of infratentorial craniotomies, it is characterised by a delayed~     onset of mutism and emotional lability, and may comprise motoric and cognitive cerebellar~     deficits. Transient mutism gives way to prolonged, and often incomplete, recovery.~     Neuroimaging studies are beginning to reveal anatomical and functional aberrancies in the~     brain of children with pCMS. The cerebellar efferent pathways are likely to be implicated as~     a neuroanatomical substrate in the development of pCMS, as shown by a handful of diffusion~     tractography studies to date. However, the pathophysiology of this condition still remains~     unclear. Hypoperfusion of supratentorial cortical and subcortical structures may mediate the~     speech and behavioural deficits seen in pCMS, and is a candidate for a causal~     pathophysiological mechanism.~      This study aims to prospectively image children with pCMS using advanced MRI techniques~     including diffusion tractography and arterial spin labelling, and to correlate this with~     clinical descriptions of the syndrome.~      All children referred to Great Ormond Street Hospital for Children with a posterior fossa~     brain tumour will be imaged pre-operatively, post-operatively and at delayed follow-up. In~     tandem with this, clinical assessments will be made of children post-operatively to ascertain~     which patients develop pCMS. In addition, anonymised advanced MRI data on healthy controls~     will be used as a comparator group.~   "
7322|NCT03471013|"~     Only one third of patients with schizophrenia are observant to their treatment knowing that~     the lack of adherence to treatment is one of the most important predictors of relapse.~      Recent work shows that the erroneous or negative beliefs of patients with schizophrenia~     regarding antipsychotic treatment are associated with poor compliance.~      The hypothesis is that negative beliefs about the antipsychotic treatment of caregivers of~     patients with schizophrenia may be associated with a higher risk of poor compliance compared~     to caregivers with positive beliefs about treatment.~      The primary purpose is to explore the correlation between caregiver beliefs about treatment~     and patient compliance, taking into account the level of caregiver-patient link.~   "
7323|NCT03471000|"~     The aim of the study was to determine whether implant length and the crown-to-implant (C/I)~     ratio influence implant stability and the loss of the surrounding marginal bone, and whether~     short implants can be used instead of sinus augmentation procedures.~   "
7324|NCT03470987|"~     Visfatin is an adipokine that plays an important role in immune functions as a growth factor,~     enzyme, and proinflammatory mediator. The investigators aimed to determine the levels of~     visfatin, interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha) in gingival~     crevicular fluid (GCF) in both obese/non-obese patients, with/without generalized chronic~     periodontitis (GCP). Patients were categorized as obese (O) (n=31) or non-obese (nO) (n=19).~     Groups were divided into four subgroups according to periodontal conditions: (1)~     periodontally healthy without obesity (nO-Ctrl); (2) GCP without obesity (nO-CP); (3)~     periodontally healthy with obesity (O-Ctrl); and (4) GCP with obesity (O-CP). Demographic~     variables and anthropometric and laboratory data were recorded. Periodontal measurements were~     recorded at baseline and 3rd months after either non-surgical periodontal treatment or~     calorie restricted diet therapy. At the same time GCF samples were taken from patients to~     analyze TNF-alpha, IL-6, and visfatin levels.~   "
7325|NCT03470974|"~     This study aims to investigate the relationship among self-efficacy, anxiety, depressive~     symptoms, quality of life, lifestyle, heart rate variability and blood pressure control; and~     to examine the effects of self-titration strategy on self-efficacy, anxiety, depressive~     symptoms,heart rate variability, sodium excretion, lifestyle modification,quality of life,~     and blood pressure control in patients with hypertension.~   "
7326|NCT03470961|"~     A single-centre, prospective, observational study to evaluate the safety and efficacy of~     Polyclonal Antibodies in simultaneous Pancreas Kidney Transplant recipients.~   "
7327|NCT03470948|"~     The number of new cases of pancreatic cancer is 12.4 per 100,000 men and women per year. The~     number of deaths is 10.9 per 100,000 men and women per year. These rates are age-adjusted and~     based on 2009-2013 cases and deaths1. This cancer has a very poor prognosis and around 7.7%~     of these patients have a 5 years survival rate. Whipple procedure is the surgical treatment~     option for cancer pancreas, where the head of the pancreas, the gallbladder, part of the~     stomach, part of the small intestine, and the bile duct are removed.Those that undergoes this~     procedure, the 5 year survival rate increases to about 20%2. The duration of intensive care~     unit monitoring and hospital stay are longer than for most upper gastrointestinal surgeries.~     Pancreaticoduodenectomy is a major operation, carrying significant risk of morbidity and~     mortality with 30 - 60% complication rate3. The possibility of identifying patients at risk~     for postoperative complications and targeting them from surveillance and early treatment~     offers an opportunity to develop interventions that might significantly improve outcomes and~     efficiency. Gawande et al. developed and validated the surgical Apgar score (SAS) and~     demonstrated that SAS can be useful for rating the condition of patients after general or~     vascular surgery4. SAS is based on intraoperative blood loss, blood pressure, and heart~     rate3. The score is very simple and easy to calculate and can be available immediately after~     surgery. Several validation studies have reported that SAS is useful for predicting the risk~     of complications associated with various procedures4-10. We investigated this SAS could~     predict major postoperative complications among patients undergoing Whipples procedure in~     patients with pancreatic cancer.~   "
7330|NCT03470909|"~     Prospective collection of health related personal data and biological material (tissue~     biopsy) in patients undergoing mastectomy.~   "
7339|NCT03470779|"~     The aim of this study is to assess the impact and feasibility of an interdisciplinary group~     treatment approach, involving psychotherapy and physiotherapy, with survivors of torture that~     are incarcerated in a prison in Kurdistan, Iraq. The primary aim is to develop initial~     estimates of treatment effects on symptoms and poor functioning consistent with centralized~     pain and post-traumatic stress disorder, anxiety, and/or depression. The secondary aim is to~     assess the feasibility of studying this interdisciplinary treatment program in which local~     Kurdish psychotherapists and physiotherapists provide a 10-week intervention in a prison, in~     the Kurdish Sorani language, and to Kurdish participants that present with mental health~     symptoms, physical complaints, and poor functioning~   "
43905|NCT02992132|"~     To evaluate the efficacy of pimavanserin compared with placebo in treatment of agitation and~     aggression after 12 weeks of treatment~   "
7331|NCT03470896|"~     Since the publication of the law  Hôpital, Patients, Santé, Territoire  of 2009 in France,~     the development of telemedicine is a public health issue. It is also a government priority~     registered in the government investment plan of 2017-2018.~      The quality of preanesthesia teleconsultation at home, through video-conference, has never~     been tested in practice.The aim of this study is to evaluate the quality of preanesthesia~     teleconsultations through video-conference, compared with traditional preanesthesia~     consultations. The quality is established by the assessment of the primary outcome : the~     risks related to difficult intubation, in patients undergoing ambulatory surgery at the~     Surgical Center Emile Galle. Our research hypothesis is that there is no difference between~     the quality of preanesthesia teleconsultations through video-conference, and the quality of~     traditional preanesthesia consultations. Secondary objectives are to identify satisfaction~     and preoperative anxiety of patients regarding teleconsultation, to identify satisfaction of~     practioners regarding teleconsultation, to evaluate the quality (based on the assessment of~     secondary outcomes) of preanesthesia teleconsultations compared with traditional~     preanesthesia consultations, and to evaluate the technical viability of generalising~     preanesthesia teleconsultation.~   "
7332|NCT03470883|"~     To evaluate the long-term complete remission rate (> 12 months) after endoscopic treatment of~     early neoplastic colorectal lesions.~   "
7333|NCT03470870|"~     Validation of a predictive nomogram of a short hospital stay (less than two days after~     surgery) on a prospective cohort of patients.~   "
7334|NCT03470857|"~     The research aims to determine the parameters of oxidative stress and inflammatory processes~     and compare these parameters with the image obtained using positron emission tomography (PET)~     with 2-deoxy-2-[fluorine-18]fluoro- D-glucose (18F-FDG) integrated with computed tomography~     (CT) in the group of oncological patients.~   "
7335|NCT03470844|"~     The long term survival of patients who require admission to critical care (CC) following a~     major burn injury (MBI) continues to improve with advanced clinical management. There has~     been increasing interest into cognitive dysfunction (CD) due to neuroinflammation (NI)~     following CC, anaesthesia, surgery, and the association of NI with diseases characterised by~     CD such as Alzheimer's disease. Patients who suffer a MBI and who subsequently require~     admission to CC will be at uniquely high risk for CD. MBI produces an exaggerated and~     prolonged systemic inflammatory response, with NI demonstrated in animal models. Additionally~     NI can be exaggerated by insults such as sepsis, anaesthesia, and surgical trauma, common and~     often necessary following MBI. The aim of this study is to identify CD using cognitive tests~     to examine for deficits in working memory and executive function. Test proposed to use are~     the Hopkins Verbal Learning and Verbal Fluency tests, and a validated computerised battery~     (CogState). Neuroinflammation and underlying pathophysiology using fMRI and spectroscopy,~     known to demonstrate biomarkers for CD and NI. QoL will be assessed using the validated EQ-5D~     tool.~      The Inclusion criteria; patients who survive their burns injury (greater than 15% total body~     surface area) and require mechanical ventilation. Primary exclusion criteria; admission with~     toxic epidermal necrolysis syndrome, and evidence of head trauma.~   "
7336|NCT03470818|"~     The primary objective of this study is to assess if letting learners know in advance what~     medical illnesses will be practiced in an upcoming simulation session and providing them with~     instruction regarding that medical content ahead of time (flipped classroom model) will allow~     them to focus on the application of Crisis Resource Management (CRM) principles during a~     simulation session and result in an increase retention of theses skills. Secondary objectives~     of this study are to assess the relationship between the study intervention and learners'~     emotional responses and its impact on the retention of non-technical skills, in occurrence~     CRM~   "
7337|NCT03470805|"~     Epithelial ovarian cancer harbours 20% Breast Cancer gene (BRCA)1/2 mutations independently~     of family history. Poly ADP ribose polymerase (PARP) inhibitors (PARPi) have shown clinical~     activity among patients with homologous recombination deficiency (HRD) and specifically among~     BRCA1/2 mutation carriers.~      The European Medicines Agency (EMA) approved the use of olaparib as maintenance therapy as~     monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed~     BRCA mutated (germline and/or somatic) high-grade serous epithelial ovarian, fallopian tube,~     or primary peritoneal cancer who are in response (complete response or partial response) to~     platinum-based chemotherapy.~      Trabectedin and Pegylated liposomal doxorubicin (PLD) have shown relevant activity in~     relapsed epithelial ovarian cancer. In the relapse with Treatment-free interval of last~     platinum (TFIp) between 6 and 12 months this efficacy translated into an increase in Overall~     survival (OS) and Progression free survival (PFS).~      There is an increase of hypersensitivity reactions (HSR) among platinum sensitive patients,~     that reaches 44% in third line and does not always allow for platinum use despite~     desensitization protocols. In relapse with TFIp between 6-12 months the use of~     Trabectedin+PLD is accepted in guidelines and consensus.~      Following clinical BRCAness criteria a group of patients that harbours up to 50% of BRCA1/2~     mutations can be selected. Olaparib has been licensed according to EMA for maintenance in~     BRCA mutated patients after response to platinum following Study 19 phase II trial and~     further confirmed with phase III SOLO-2 data. However there is no evidence of the benefit of~     adding olaparib after Trabectedin+PLD response among BRCA1/2 carriers.~      The combination of Trabectedin+PLD, as well as both single drugs, have shown higher activity~     among BRCA1/2 carriers.~   "
7338|NCT03470792|"~     One of the key factors of survival of patients with extra-corporeal membrane oxygenation~     (ECMO) life support system is whether the blood flow supplied by ECMO can meet the need of~     perfusion of each organ. In our previous study, we found that microcirculaton parameters~     within 12h after placement of venoarterial ECMO (VA-ECMO) were lower in the 28-day~     non-survivors than those in the survivors. Moreover, in our ongoing observational clinical~     trial, we found that adjustment of ECMO blood flow could improve microcirculatory dysfunction~     in some patients. We hypothesize that if we can find out the patients with poor~     microcirculation and use the microcirculation parameters to assist the adjustment of ECMO~     blood flow and related treatments, we might improve the survival of these patients. In this~     clinical trial, the patients will receive microcirculation examination within 12h after~     placement of ECMO. The patients were randomly divided into control and~     microcirculation-assisted groups. The microcirculation parameters in patients of the~     microcirculation-assisted group will be given to the ECMO team, and the ECMO blood flow and~     relative treatments will be adjusted according to macrocirculation parameters, clinical~     condition, and microcirculation parameters. In the patients of the control group, the ECMO~     blood flow and related treatments will be adjusted according to macrocirculation parameters~     and clinical condition. The microcirculation will be measured again at 24h and 48h after~     placement of VA-ECMO, and the ECMO and related treatments will be adjusted as previous~     description. The microcirculation will be measured at 72h after placement of VA-ECMO. The~     ECMO setting, intake-output balance, dose of inotropic and vasopressors, and prognosis will~     be recorded. The difference will be compared between the two groups.~   "
7341|NCT03470753|"~     Patients seeking care for chronic low back or knee pain will be recruited for enrollment, and~     randomized within two phases (retention and compliance). Patients will consent to a 2-step~     study design, with independent randomization for each. The initial step will assess retention~     based on 4 different exercise prescription strategies. This will be assessed short-term, and~     then the 2nd step will consist of a second independent randomization to receive different~     reminder strategies to determine their influence on exercise compliance at home.~   "
7342|NCT03470740|"~     Rheumatoid arthritis (RA) is a persistent systemic disease. WHO (World Health Organization)~     commented that a crucial goal of heath care for RA is prevention of loss of daily function by~     patients' self-management (SM) skills; however, a comprehensive rheumatoid arthritis~     self-management (RASm) for RA patients' day-to-day self-managing is limited in Taiwan.~      Aims: The aims of the study are: (1) to implement the RASm program, (2) to determine the~     effectiveness of the program with 6 months follow-up, and (3) to understand participants'~     experiences when receiving the RASm program for the experimental group.~   "
7343|NCT03470727|"~     Acetate-free citrate containing dialysate is expected to be clinically effective in~     maintaining hemodynamic stability during hemodialysis (HD). It has been demonstrated that~     citrate dialysate help produce a local anticoagulant effect by chelating ionized calcium.~     Moreover, citrate can improve phosphate and beta2 macroglobulin and better control of~     arterial hypertension and hemoglobinemia. We therefore would like to study the effect of~     citrate dialysate on clot formation and anemia while reducing heparin in chronic hemodialysis~     patients.~   "
7344|NCT03470714|"~     The study is assessed the electromyographic activity response of non-dominant biceps brachii~     muscle during unilateral-dominant concentric, eccentric and isometric biceps brachii muscle~     contractions under kinesiotaping and non-taping conditions. The aim of the study is to~     determine the synergistic effect of kinesiotaping which is applied on non-dominant biceps~     brachii muscle on force irradiation.~   "
7345|NCT03470701|"~     This study will test the effectiveness of mailed, smartphone urinalysis kits to improve~     albuminuria screening compliance and detection of albuminuria.~   "
7346|NCT03470688|"~     An observational study investigating the utilisation and effectiveness of originator and~     biosimilar anti-TNF agents in patients with rheumatoid arthritis, psoriatic arthritis, or~     ankylosing spondylitis.~   "
7347|NCT03470675|"~     Obstetric anal sphincter injuries (OASIS) encompass both third and fourth degree perineal~     tears. These tears can have a significant impact on women's quality of life in the short and~     long term. One of the most distressing immediate complications of this severe perineal injury~     is perineal pain. Women can also experience postpartum depression, dyspareunia, and altered~     sexual function after OASIS.~      This is a randomized controlled trial to study the effects of three interventions (placebo,~     low dose intravenous ketamine plus epidural morphine, or epidural morphine alone) on acute~     pain after OASIS.~      The objective of this study is to assess the incidence of perineal pain in postpartum~     patients 1 week after obstetric anal sphincter injuries.~   "
7348|NCT03470662|"~     Objective: To evaluate the effect of care bundle on prevention of delirium among elderly~     patients with hip fractures.~      Methods: A prospective randomized case control study was performed for 80 patients (≥65~     years) with hip fractures treated surgically according to their ages and the type of~     fractures from March 1th of 2017 to June 30th of 2017．There were 11 males and 69 females,~     with the age of (79.3±7.84) years. Confusion assessment method (CAM) was applied to diagnose~     delirium after surgery, the subjects were randomized divided into experimental group (n=43)~     and control group (n=37). The parameters next were recorded and analyzed, including age,~     gender, type of fractures, type of internal instrument, amount of bleeding, time between~     injured to surgery, time length of operation, type of operation, VAS, incidence of delirium,~     perioperative complications and adverse events.~   "
7349|NCT03470649|"~     Postoperative anemia is a frequent complication after total knee arthroplasty, with an~     incidence of 87%. Iron supplementation is known to be effective in treatment and prevention~     of postoperative anemia. The investigators examined the effect of intravenous iron~     isomaltoside (Monofer®) administration on postoperative anemia and transfusion requirements~     in patients undergoing total knee arthroplasty.~      Participants undergoing total knee arthroplasty will be randomly assigned to treatment group~     or control group. After main procedure of total knee arthroplasty, iron isomaltoside 1000~     (Monofer®) or normal saline will be intravenously administered depending on the group~     assigned. The dose of iron isomaltoside will be determined based on patient's body weight~     using the manufacturer's recommendation. Serum hemoglobin, hematocrit, iron, ferritin,~     transferrin saturation, and phosphorus level will be checked at preoperative day,~     postoperative day 1, 7, and 30.~      The primary outcome is the incidence of postoperative anemia at 30 days after surgery.~     Secondary outcomes included the incidence and amount of red blood cell transfusion during~     admission period, hospital length of stay, the incidence of surgical site infection, and~     quality of life during postoperative period.~   "
7350|NCT03470636|"~     The objective of the study is to demonstrate the improved ablation and procedure times of the~     HeartLight X3 compared to the current HeartLight catheter in the treatment of atrial~     fibrillation.~   "
7367|NCT03470415|"~     The heart and vessels are surrounded by layers of adipose tissue, which is a complex organ~     composed of adipocytes, stromal cells, macrophages, and a neuronal network, all nourished by~     a rich microcirculation. The layers of adipose tissue surrounding the heart can be subdivided~     into intra- and extra-pericardial fat. Their thicknesses and volumes can be quantified by~     echocardiography and computed tomography or magnetic resonance imaging, respectively. The~     term extrapericardial fat defines thoracic adipose tissue external to the parietal~     pericardium. It originates from primitive thoracic mesenchymal cells and thus derives its~     blood supply from noncoronary sources. Intrapericardial fat is further subdivided into~     epicardial and pericardial fat. Anatomically, epicardial and pericardial adipose tissues are~     clearly different. Epicardial fat is located between the outer wall of the myocardium and the~     visceral layer of pericardium.~   "
7378|NCT03470272|"~     Red light laser therapy using 635nm red light laser technology has previously been shown to~     cause lipolysis in subcutaneous fat as a non-surgical method to promote weight loss and body~     contouring. This study hypothesizes that red LED light therapy using 650nm red light LED~     (light emitting diode) technology produces similar results to the laser device (red LASER~     635nm) when preformed using a specified treatment protocol.~   "
7351|NCT03470623|"~     Hallux valgus is the most common deformity of forefoot and the patients would suffer pain and~     disable of walking and wearing normal shoes. Chevron osteotomy of the first metatarsal is~     widely used for the treatment of mild or medium hallux valgus. It is a V sharp osteotomy~     that can decrease the intermetatarsal degree of first-second metatarsal by pushing the distal~     side of osteotomy laterally.A 2.5mm or 3.0mm steel cannulated screw is usually used for the~     fixation of the osteotomy side to provide stability.However,there are some shortcomings of~     steel screws such as rejection of internal fixation or the financial cost of the second~     surgery of fixation taken-out. To obviate these shortcomings of steel screws, bioabsorbable~     screw fixation may be an alternative method for chevron osteotomy.~      This trial is a randomized, prospective, controlled, parallel experimental design, to compare~     the clinical and radiographic outcomes of bioabsorbable screw versus steel screw for the~     treatment of hallux valgus with chevron osteotomy. The patients will be randomized to two~     groups, one treated with bioabsorbable screws while the other treated with steel screws.Data~     collection for the outcomes measures will occur pre-op,immediate post-op and then 6 weeks, 12~     weeks, and at 1 years post operation.~      The clinical outcomes measure are the VAS (visual analogue scale) score and AOFAS (American~     orthopedic foot and ankle society) forefoot score.The radiographic outcomes measures are the~     IMA (intermetatarsal angle) and the HVA (hallux valgus angle)~   "
7352|NCT03470610|"~     Observational study of reproductive outcome after frozen embryo transfer in HRT with vaginal~     and rectal progesterone.~   "
7353|NCT03470597|"~     Pre-gestational performance of hysterosalpingography (HSG) using an oil-soluble iodinated~     contrast medium has been demonstrated to be the main cause of excessive iodine exposure for~     pregnant women. However, its long-term health effects on the mothers and offsprings have not~     been adequately elucidated. A case registry study is designed to follow up all the pregnant~     women with pre-gestational history of ethiodized-oil HSG examination and try to keep track of~     maternal and fetal outcomes.~   "
7354|NCT03470584|"~     To investigate the prospective association between a vegetarian diet and chronic degenerative~     diseases in two cohorts of Taiwanese Buddhists~   "
7355|NCT03470571|"~     Presentation of myocarditis is heterogeneous, often ranges from being asymptomatic, to chest~     pain, dyspnoea, palpitations, and even sudden cardiac death. Diagnosing myocarditis is~     challenging with no current uniform clinical gold-standard. CMR is a key investigative tool,~     however the predictive value of CMR features is unknown. In this study we assess 670~     consecutive patients with suspected myocarditis who were referred for CMR between 2002 and~     2015 at the BWH. CMR features such as late gadolinium sizing, T1 mapping, extracellular~     volume fraction assessment, strain analysis (feature tracking), clinical data, labortory~     tetsings and electrocardiogramm are linked to the outcome in order to assess its predictive~     value.~   "
7356|NCT03470558|"~     The purpose of the study is to evaluate how dietary habits in the post-surgical year impact~     outcomes of bariatric surgery.~   "
7357|NCT03470545|"~     This is a multicenter, international, double-blind study of the administration of mavacamten~     in participants with symptomatic obstructive HCM (oHCM). Approximately 220 participants will~     be randomized to receive placebo or mavacamten.~   "
7358|NCT03470532|"~     This study compares the the efficacy of buccal infiltration of 4% Articaine and 2%~     Mepivacaine without any palatal injection during extraction of maxillary teeth. One group of~     patient receives buccal infiltration of Articaine and another group receives buccal~     infiltration of Mepivacaine.~   "
7359|NCT03470519|"~     The study aims to develop a quick tool to assess magnesium intakes.~   "
7360|NCT03470506|"~     The purpose of this pilot study is to investigate the relationship between gut microbial~     composition and stroke outcome. If we can establish a relationship between gastrointestinal~     microbial community composition and convalescent ischemic stroke outcomes in a U.S. sample,~     such results would prompt further mechanistic studies, and ultimately provide a rationale for~     trials to determine whether modulating intestinal immune responses (e.g. via prebiotic,~     probiotic, or fecal transfer methods) would be beneficial.~   "
7361|NCT03470493|"~     This study compares the diagnostic capability of a home sleep apnea testing device to~     polysomnography.~   "
7362|NCT03470480|"~     The primary aim of this project is to use a randomized single-blind sham-controlled study to~     investigate if high frequency repetitive transmagnetic stimulation (HF-rTMS) can modulate~     cue-induced craving in adult methamphetamine (METH) users. The investigators hypothesize that~     HF-rTMS directed at left dorsolateral prefrontal cortex (DLPFC) will result in a reduction in~     craving for METH compared to sham-controlled rTMS in adults with methamphetamine use disorder~     (MUD) as evidenced by validated measures of METH craving. Neurobiologically, the~     investigators anticipate rTMS mediated stimulation of the DLPFC could result in inhibition of~     cue-induced craving through potential disruption of involved circuitry. The current project~     proposes that participants who are recently abstinent from METH will be randomized into four~     experimental groups to provide two rTMS conditions (real versus sham) and two picture cues~     conditions (METH versus neutral). The experiment will have an induction phase where each~     subject will receive 10 daily treatments within 2 weeks. Just before each rTMS/sham session~     participants will be shown visual cues (METH or neutral). Participants will then undergo a~     maintenance phase for an additional month with assessments to evaluate craving and relapse.~     Urine samples for urine drug screening (UDS) will be collected at screening day and on days~     1, 5 and 10. Just before each rTMS/sham session participants will be shown visual cues (METH~     and neutral). VAS craving scores will be assessed before and after picture presentation and~     after the rTMS/sham session. Before the first and 10th treatment session, participants were~     evaluated by the the Stimulant Craving Questionnaire (STCQ) and the Severity of Dependence~     Scale (SDS) questionnaires. Participants will then undergo a maintenance phase for an~     additional month. During the first week of maintenance, three rTMS/sham sessions will be~     administered. During each of the following 3 weeks, one rTMS/sham session will be given per~     week. As with the induction phase, urine samples will be collected for screening and STCQ and~     the SDS questionnaires will be completed at each maintenance session. To evaluate the~     long-term effects of the rTMS treatment, the investigators plan on contacting participants 6~     months after treatment termination for all subjects who completed the 10 treatment sessions.~     During that phone conversation, craving and relapse will again be assessed.~   "
7363|NCT03470467|"~     Posterior Reversible Encephalopathy Syndrome prospective (PRES) registry. Data collection~     using a standardized form : demographic data and data related to the PRES, including~     circumstances of onset, dates and times of onset and of symptoms control, on-scene clinical~     findings, clinical and radiological features of PRES, pre-hospital and hospital care~     providers, timing of antiepileptic, antihypertensive drugs and supportive treatments, results~     of etiological investigations, cause of PRES, type and dosage of antiepileptic and~     antihypertensive drugs. Dates and times of EEG monitoring, EEG results, radiological and~     biological investigations. Outcomes including vital status and Glasgow Outcome Scale score at~     ICU and hospital discharge, day-90 and 1-year after SE and determined based on data in the~     ICU and/or neurologist charts and/or patients phone interview~   "
7364|NCT03470454|"~     To study the effect of radiocontrast material on kidney functions in diabetics with~     microalbuminuria~   "
7368|NCT03470402|"~     The objective of this study is to expand genetic testing for hereditary breast and ovarian~     cancer syndrome to a broader population of high-risk women by prompting appropriate referrals~     from the primary care setting with the use of an electronic health record-embedded breast~     cancer risk navigation (BNAV) tool. To address patient-related barriers to genetic testing,~     we developed a web-based decision aid, RealRisks, which is designed to improve genetic~     testing knowledge, accuracy of breast cancer risk perceptions, and self-efficacy to engage in~     a collaborative dialogue about genetic testing.~      The study design is a randomized controlled trial of patient educational materials and~     provider EHR notice alone (control arm) or in combination with RealRisks and BNAV~     (intervention arm). The researchers hypothesize that combining the patient-centered RealRisks~     with the provider-centered BNAV will increase appropriate uptake of genetic counseling. The~     researchers also hypothesize that genetic counseling decisions will be more informed, and~     result in less decision conflict and improved shared decision making.~   "
7369|NCT03470389|"~     This is an open-label, non-randomized, multi-center trial that will be conducted at Shanghai~     Ninth People's Hospital, Renji Hospital and Xinhua Hospital. In this study, the investigators~     aim to establish the HVPG using biofluid mechanics (HVPGBFM) model using biofluid mechanics~     methods and validate the HVPGBFM model. First, in the original cohort, the investigators will~     use some of the patients' clinical data to establish and improve the HVPGBFM model; then, in~     the validation cohort, the investigators will calculate the HVPGBFM of the other patients,~     compare the HVPGBFM and HVPG, and assess the model.~   "
7370|NCT03470376|"~     The effects of a nutraceutical combination (NC) containing low-dose monacolin K and berberine~     on lipid profile, proprotein convertase subtilisin/kexin type 9 (PCSK9), subclinical~     inflammation and arterial stiffness were investigated in human immunodeficiency virus~     (HIV)-infected patients receiving stable antiretroviral therapy (ART).~   "
7371|NCT03470363|"~     Aim of study : Assessement of neutrophil activation during ischemia reperfusion associated~     with tourniquet use for total knee arthroplasty. This activation was compared in a group of~     patient scheduled for spinal anesthesia and for sevoflurane anesthesia~   "
7372|NCT03470350|"~     Part I of this study is designed to identify the recommended phase 2 dose (RP2D) of the~     combination regimen of galunisertib/capecitabine as second line treatment in patients with~     5-FU or capecitabine resistant CRC. Part II is designed to obtain proof of principle of the~     galunisertib plus capecitabine combination in patients with chemo-resistant CRC. The~     combination of galunisertib plus capecitabine will be given as second line therapy in the~     phase II part of this study.~      Patients with chemotherapy resistant activated TGF-β signature-like tumors will have received~     a fluoropyrimidine (5FU or capecitabine) in the first line of chemotherapy, usually combined~     with oxaliplatin and, depending upon local hospital preferences or national guidelines, also~     bevacizumab, or cetuximab/panitumumab if the tumor is KRAS wild type. Addition of~     galunisertib to capecitabine should thus result in reversal of unresponsiveness, which is the~     first step in exploring this concept in the clinic. Capecitabine can be used as single agent~     in advanced CRC and is thus attractive for this study concept. If proof of principle is~     achieved also other tumor types can be explored with this genetic makeup, such as non-small~     cell lung cancer (NSCLC) in second line of treatment after platinum doublet therapy in first~     line, usually cisplatin/carboplatin-pemetrexed in non-squamous and~     cisplatin/carboplatin-gemcitabine or cisplatin/carboplatin-paclitaxel in squamous type NSCLC.~   "
7373|NCT03470337|"~     Oral enzyme therapy in patients with acute superficial vein inflammation (thrombophlebitis)~     can serve as an additional treatment option besides standard therapy with compression~     stockings, common pain medication and physical treatments. This randomized, double-blinded~     trial compares efficacy and safety with placebo.~   "
7374|NCT03470324|"~     20 patients with idiopathic Parkinson's disease and dysphagia will be included into this~     randomised controlled double-blinded parallel group clinical trial. The treatment consists of~     two different stimulation settings using (i) conventional stimulation of the subthalamic~     nucleus [standard STN] as active comparator and (ii) combined stimulation of active electrode~     contacts located in both the subthalamic nucleus and substantia nigra pars reticulata~     [STN+SNr]. Both groups receive additional swallowing therapy as standard of care.~   "
7375|NCT03470311|"~     In severe prednisone-dependent eosinophilic asthma, Benralizumab would suppress airway~     eosinophilia that is not suppressed by either Mepolizumab or Reslizumab and this would be~     associated with greater asthma control~   "
7376|NCT03470298|"~     ES is a procedure used to help embryos to implant more successfully after In-Vitro~     Fertilization (IVF) , ICSI in patients who had failed cycles in spite of transfer of good~     quality embryos. New researches and evidence suggests that scratching the uterine endometrium~     causes a repair reaction in patients may increase embryo implantation rate . In spit of the~     optimum timing of scratching not finally determined, the usual timing to perform ES is~     approximately one week before starting IVF, ICSI treatment . our study aims to compare other~     time of scratching which is the scratching at retrieval time.~   "
7377|NCT03470285|"~     Renal cell carcinoma represents annually 3-5% of all new cancer diagnoses. To date, the~     standard of care for small renal masses is partial nephrectomy. However, in the specific~     setting of small renal masses, 20% of them are benign and surgery results in overtreatment.~     Non-invasive techniques able to differentiate the inherent characteristics of tumors (nature,~     aggressiveness) would be useful to offer the most appropriate therapeutic options.~     Morphological ultrasound or CT imaging appeared limited because of the lack of discriminatory~     power. Based on the data of retrospective studies, the hypothesis is that multiparametric~     (mp) MR parameters using chemical shift, diffusion and/or contrast injection techniques may~     be a reproducible diagnostic test with sufficient diagnostic accuracy to differentiate benign~     from malignant renal tumors. The originality of this project lies in the opportunity to~     simultaneously assess the performance of mpMRI in diagnosing renal tumors in a routine~     clinical practice in 18 centers. In each center, two independent MRI readings performed by~     two radiologists will be carried out within a short delay and interpreted blind to each~     other's results or pathological results using a predefined template. A third reading will~     also be centrally performed by the coordinating center according to similar modality. All~     clinical, radiological and pathological data will be collected after anonymization in the~     UroCCR database. These informations are used to adjust the therapeutic decision and selecting~     patients eligible for nephrectomy, other therapeutic options or monitoring.~   "
7379|NCT03470259|"~     Almost 50 % of papillary thyroid cancer (PTC) patients have central lymph node metastases~     (CLNM), which are associated with a high risk of persistent or recurrent disease. However,~     the practice of performing a prophylactic central lymph node dissection (PCLND) routinely~     remains controversial. The proponents argue that without a PCLND, PTC patients with positive~     lymph nodes have an increased risk of local recurrence, and postponed node dissection leads~     to with 5-6 fold higher risk of morbidity. If performed, PCLND in clinical node negative~     patients increases staging to pN1 in more than 50% of the cases without increasing survival.~     The complication rate in PCLND is lower when compared to a technically challenging~     re-exploration in recurrent disease, with reported incidences of 0.6% and 7.3-20%,~     respectively. Opponents of routine PCLND point out the lack of randomized clinical trials and~     object to treatment-induced hypo-parathyroidism and recurrent nerve damage for the N0~     patients. Currently, no diagnostic tool is available which reliably identifies these patient~     categories. Therefore, there is a clear need for novel diagnostic imaging modalities that~     overcome this issue. Molecular Fluorescence Guided Surgery (MFGS) is potentially such a~     diagnostic tool. The administration of NIR fluorescent tracers can increase detection~     accuracy of cancer and nodal metastatic tissue using macroscopic MFGS. Therefore, we aimed to~     identify a GMP-produced near infrared (NIR) tracer that potentially has a high~     target-to-background ratio in PTC compared to normal thyroid tissue. Tyrosine-protein kinase~     Met (c-Met) is significantly upregulated at the protein level in PTC compared to normal~     thyroid tissue. The investigators therefore hypothesize that the GMP-produced NIR-fluorescent~     tracer EMI-137 (targeting c-Met, peak emission at 675 nm range) might be useful for~     intraoperative imaging of PTC and nodal metastases. The investigators' aim is to investigate~     if the administration of EMI-137 is a feasible approach to enable intraoperative selection of~     PTC patients for CLND. Eventually, secondary the investigators might also be able to~     visualize multifocality, more selective lateral neck dissections and asses residual tissue~     after thyroidectomy. Ultimately, all of these strategies may reduce overtreatment, morbidity,~     and costs while maintaining the same or better effectiveness with a lower recurrence rate and~     improved quality of life.~   "
7380|NCT03470246|"~     The PACO trial is a randomized clinical trial conducted in Heart Centers of Kuopio and Turku~     university hospitals. The coronary artery disease, aortic valve stenosis and mitral valve~     insufficiency patients preparing for elective coronary artery bypass grafting (CABG), aortic~     valve replacement (AVR) or mitral valve repair (MVR) will be randomized to either~     intervention or control group. The specific operation groups (CABG, AVR and MVR) will be~     analyzed separately. The 7-day baseline measurements of sedentary behaviour (SB), physical~     activity (PA) and sleep will be conducted to the patients by using the RM42 accelerometer~     during the pre-operative month.~      After the cardiac procedure is completed and the patient is moved to post-operative ward, the~     control group patients will begin the standard post-operative rehabilitation program of the~     participating hospitals (activity guidance given by a physiotherapist). Patients in the~     intervention groups will follow the identical program but after discharge they will also~     receive personalized activity guidance through the combination of ExSed smart phone~     application, Suunto MoveSense accelerometer and cloud system during the first 90 days of~     post-operative rehabilitation. Weekly evolving daily goals to replace SB with PA (daily goals~     for steps, moderate PA, light PA and standing, and sitting time limit) will be designed for~     each patient of the intervention groups. A new daily step goal will be delivered from the~     cloud system to the patient's smart phone in the beginning of each week of the intervention.~     The daily step goal of the first intervention week is based on patient's walking distance~     assessed by a physiotherapist in post-operative ward. The following goals will be~     automatically evolved in the basis of patient's personal average step count of the previous~     week. The MoveSense accelerometer will measure accumulated levels of SB, PA and sleep, and~     transmit the data to user's ExSed application with Bluetooth. With information about~     accumulated levels of SB and PA, the application is able to guide the patient to accomplish~     the predefined activity goal. The guidance and motivation will be offered with pop-up~     notifications and histograms (columns are fulfilled according to patient's accumulated daily~     activity). The researches retain a remote access to the activity data of patients in the~     cloud system. The ExSed application will be connected to the cloud system with internet~     connection.~      In addition, the patients of the intervention groups will receive short video files (lasting~     from 1 to 3 minutes) containing exercise guidance from a physiotherapist specialized to~     cardiac operation patients. These videos are available on the ExSed application during the~     intervention. The physiotherapist will also contact each patient (by mobile phone) with~     structured contact form from 1 to 4 times in a month to make sure that the intervention is~     proceeding as designed.~   "
7381|NCT03470233|"~     Deltyba Registry aims to collect the usage information of Deltyba which could be a factor of~     developing resistance in actual clinical settings.~   "
7382|NCT03470220|"~     The aim of this study is:~        1. To describe the natural course of acute cholecystitis, by performing repeated ultrasound~          examinations from day of admission to hospital until day of surgery or discharge.~        2. To investigate if there is anything in the ultrasound picture that can predict a~          difficult operation.~      Patients will be prospectively enrolled. The ultrasound picture (ultrasound variables:~     gallbladder volume, gallbladder wall thickness, and presence of oedema in the gallbladder~     wall), will be compared to clinical variables (tenderness in right upper quadrant, WBC, CRP~     and temperature) and to the time (hours) from onset of symptoms. Statistical analyses will be~     made to see if statistically significant, and clinically relevant, associations between~     variables exist.~      Furthermore, for participants receiving acute surgery, an upper GI surgeon will evaluate the~     operation as easy, intermediate or difficult. In extension, investigators will look at~     associations between difficult surgery and all the variables previously mentioned (both~     ultrasound variables, clinical variables and time).~   "
7383|NCT03470207|"~     This research study wants to find markers in the blood that may help to predict a patient's~     future risk of developing a disease called CTEPH. The study also wants to see if active~     monitoring for signs and symptoms of CTEPH after a pulmonary embolism (a blood clot in the~     lungs) can improve the diagnosis of CTEPH.~      Patients who enroll in this study will have periodic blood draws and clinic and/or phone~     follow-up to monitor for signs and symptoms of CTEPH. Patients' medical records will also be~     reviewed for information related to pulmonary embolisms and/or CTEPH.~   "
7384|NCT03470194|"~     The aim of the study is to determine if In-person interpreters increases patient satisfaction~     of URGYN office visits compared to the use of phone interpreter services for Limited English~     Proficient (LEP) patients~   "
7385|NCT03470181|"~     Cyclic vomiting syndrome is a disorder characterized by nausea and vomiting, separated by~     periods without any symptoms. There is very little research on this field at this point and~     most doctors do not fully understand the disorder. The goal of this study is to assess how~     the stomach empties food. Participants will be asked to participate in this study because~     either (a) they have been diagnosed and/or treated for cyclic vomiting syndrome in the past,~     or (b) they are physically healthy. The study seeks to compare how a healthy person's stomach~     empties to how the stomach of someone with cyclic vomiting disorder empties.~   "
7386|NCT03470168|"~     A 30 alcohol dependent patients were divided into A: Treatment group and B: Placebo group~     using simple randomization technique. (Liver function tests) GGT, ALT and AST levels and MCV~     (Mean corpuscular volume) at admission and 2 weeks later were estimated. Daily withdrawal~     symptoms were assessed using the Clinical Institute Withdrawal Assessment scale (CIWA-Ar) and~     DTs by Delirium Observation Screening (DOS) Scale (version 0 - 1). The data collected from~     the two groups were compared.~   "
7387|NCT03470155|"~     Functional mitral insufficiency poses a challenge with regard to the optimal time of~     intervention, particularly because they are frequently associated with left ventricular (LV)~     dilation and reduced LV ejection fraction (EF). The registry will document the underlying~     pathology by using transthoracal echo cardiography (TTE) with analysis of common tenting~     parameters. OP strategies, data and outcomes will be documented, as well as follow-up data~     for echocardiography, quality of life and MACCE outcomes after 6 months, 1 and 2 years.~   "
7388|NCT03470142|"~     This study is to compare the short-term and long-term outcomes of traditional~     laparoscopy-assisted surgery and total laparoscopic surgery with no incision (natural orifice~     transluminal endoscopic surgery, NOSES) for colorectal cancer and to find a better surgical~     method for patients.~   "
7389|NCT03470129|"~     Comparison of the retention of a new fissure sealant (Helioseal F Plus) and a fissure sealant~     that has been on the market for years in children~   "
7390|NCT03470116|"~     The MILAR trial is a multicenter randomised , prospective, controlled, single-blind,~     superiority French clinical trial, with a 1: 1 distribution of patients to compare intubation~     during the first laryngoscopy between the MacGrath MAC videolaryngoscope and the MacIntosh~     laryngoscope for patients with less than 2 criteria of difficult intubation in elective~     surgery.~   "
7391|NCT03470103|"~     The main objectives of this observational cohort study are to describe the use of~     intravitreal aflibercept and to describe follow-up as well as treatment patterns in patients~     with wAMD or DME in routine clinical practice in Latin America for a study population of~     treatment naive patients and those who have received prior therapy (anti-VEGF injections,~     laser, steroids, etc.) and are being switched to intravitreal aflibercept injection.~   "
7392|NCT03470090|"~     This study was planned to evaluate the effect of neuromuscular exercise program on physical~     activity, functionality and balance in patients with knee osteoarthritis aged 35-65 years.~   "
7393|NCT03470077|"~     Our primary objective of this study is to compare the effect of administration of single dose~     of intravenous nalbuphine given with induction of anesthesia with intravenous nalbuphine~     given at the end of surgery on the incidence and severity of EA in children undergoing~     strabismus surgery under general anesthesia.~      The secondary outcomes will include modified CHEOP score for postoperative pain assessment,~     hemodynamic variables, any complications as postoperative vomiting (POV) and sedation and~     parents' satisfaction score.~   "
7394|NCT03470064|"~     This study aims to assessing right ventricular function early after surgical repair of~     tetralogy of Fallot and identifying the risk factors associated with development of RV~     dysfunction.~   "
7395|NCT03470051|"~     This is a prospective case collection study to collect cases for subsequent statistical~     studies and future reader studies.~   "
7396|NCT03470038|"~     The purpose of this study is to investigate responses of NGF and the maintenance of~     mechanical muscle hypersensitivity over time following an acute exercised-induced ischemic~     condition in an NGF-sensitized muscle.~      The hypothesis is that an ischemic conditioning in a NGF-sensitized muscle is able to~     potentiate NGF responses, induce pain, and prolong muscle hypersensitivity in comparison with~     a NGF-sensitized muscle alone.~   "
7397|NCT03470025|"~     Because of a lack of clinical trials, there is currently a paucity of evidence on the most~     effective strategies to identify and address psychological co-morbidity in COPD, or on~     targeting these interventions to specific patient groups. The relationship between~     physiological disease impairment and patient's disease experience is weak. Some patients have~     highly impaired Quality of life (QoL) despite relatively minor lung function impairment, and~     others have good QoL despite severe lung function impairment. It is likely that psychological~     and behavioral factors may be relevant; moreover the coping strategies used by patients and~     their relationship to individual psychological factors have been incompletely explored.~     Pulmonary Rehabilitation (PR) is part of integrated COPD patient management and its potential~     impact on QoL should be underlined: several studies have found that physical exercise has a~     beneficial effect on depression symptoms [GOLD, 2017].~      Before initiating PR a comprehensive and careful assessment should be performed: treatment~     goals, specific healthcare needs, smoking status, nutritional health, self-management~     capacity, health educational, psychological health status and social circumstances, medical~     history and comorbidities, and exercise capabilities and limitations. Moreover, PR has~     beneficial effects on mood status and daily activities.~      Sustaining Pulmonary Rehabilitation benefits and regular exercise over the long term is~     difficult without any maintenance strategy. The main aim of this study is to assess the~     Effect of the Psychological Intervention (PI) on Quality of life, psychological status and~     well-being, and the maintenance of Pulmonary Rehabilitation benefits, in COPD patients.~      A PI based on psychoeducation and psychological and emotional support may be a key to improve~     Quality of life and to bring COPD patients to show a greater awareness of their health~     status.~   "
7398|NCT03470012|"~     The objective of this study is to determine the relative gentleness of a new medical tape. A~     three-prong multidimensional evaluation consisting of expert grader, subject discomfort~     assessment, and laboratory assessments was used. One pre-study visit took place up to 7 days~     prior to the start of the study. The study was conducted over two days with one tape sample~     applied and removed. Assessments were taken on the final day. This was to mimic a normal tape~     application in health care practice. Assessments were compared to those taken in a previous~     study.~   "
7399|NCT03469999|"~     This study aims to evaluate the efficacy of single event multi level chemoneurolysis with the~     abobotulinumtoxinA drug, Dysport®, on walking energy expenditure and gait in children with~     spastic diplegia Cerebral Palsy.~   "
7400|NCT03469986|"~     This is an outpatient, multicenter, prospective, pivotal, double-blind, within-subject~     comparison trial of the Marcus Autism Center Investigational Device (MAC-ID) diagnostic~     procedure relative to the gold-standard (reference standard), current best practice expert~     clinician diagnosis (ECD) of Autism Spectrum Disorder (ASD) in children 16-30 months of age.~      Consecutive pediatric patients from the intended population (i.e. children 16-30 months of~     age) recruited from pediatric referrals and general advertisements will be the subjects of~     this trial. All subjects will undergo the MAC-ID diagnostic procedure (test). All subjects~     will also undergo the current best practice clinical diagnostic procedure, using standardized~     ASD diagnostic instruments and standardized developmental assessments, to produce the ECD of~     each child's ASD status (reference/gold standard).~      The study consists of a screening phase and diagnostic evaluation phase to assess the~     validity (sensitivity and specificity), safety, and effectiveness of the MAC-ID when used to~     diagnose ASD.~      Subjects will be enrolled in the trial for a period of 1 day. The trial will be completed in~     approximately 12 months.~      The overall study objective is to assess the safety and effectiveness of the MAC-ID to~     accurately diagnose ASD (primary analysis), as well as to accurately assess severity of ASD~     (secondary analysis) in very young pediatric subjects.~      The primary endpoints of this study are the diagnostic result from the MAC-ID and the~     diagnostic results from the ECD evaluation, both of which are either positive or negative for~     ASD. Each subject will undergo the Social Developmental Testing Device procedure and an~     examination by a clinical expert in the field of ASD diagnosis; all study center site~     personnel (including the expert clinicians responsible for the ECD evaluation) will be~     blinded to MAC-ID results.~   "
7401|NCT03469973|"~     The velopharyngeal valve is a tridimensional muscular valve that is located between the oral~     and nasal cavities. It consists of the lateral and posterior pharyngeal walls as well as the~     soft palate. The role of the velopharyngeal valve is to separate the oral and nasal cavities~     during speech and swallowing.~   "
7418|NCT03469739|"~     This study uses data from 29,990 women from 12 different countries collected by the WHO~     multi-country study on women's health and domestic violence to capture the effect of~     different types, frequency and timing of IPV on self-reported health, symptoms and suicidal~     behaviours.~   "
8154|NCT03460106|"~     Phase I: To develop and validate laboratory urine and blood test for the detection of~     medications commonly used in the treatment of asthma Phase II: to test the developed assay in~     the clinic, to determine its practicality to conduct, and its clinical utility in adherence~     assessment.~   "
7402|NCT03469960|"~     Non Small Cell lung cancer (NSCLC) remains the first cause of death by cancer in the World.~     For the patients presenting a NSCLC stage IV, the median of survival is about 15 months~     today. The chemotherapy with platinum is the standard treatment for these patients but~     immunotherapy showed these efficacy in 1st line for patients PD-L1 positive. On the other~     hand, the duration of treatment by immunotherapy is not clear. Indeed, prolonged responses~     and long survivals have been described in patients having interrupted the treatment. In the~     melanoma, a treatment of 6 months of ipilimumab demonstrated its efficacy. The objective of~     the study is to demonstrate that a treatment of 6 months followed by an observation (stop and~     go) is not less effective than a treatment given until progression or toxicity. This strategy~     would allow to decrease the accumulated toxicities, to improve the quality of life of the~     patients and to decrease the costs.~   "
7403|NCT03469947|"~     The California Prehospital Antifibrinolytic Therapy (Cal-PAT) study seeks to evaluate the~     safety and efficacy of Tranexamic Acid (TXA) use in the civilian prehospital and in hospital~     setting in cases of traumatic hemorrhagic shock.~   "
7404|NCT03469934|"~     The purpose of this study will also assess the safety and tolerability of ANB020 in adult~     patients with severe eosinophilic asthma.~   "
7405|NCT03469921|"~     Unicentric retrospective analysis of a cohort of 602 young adult and adolescent patients,~     aged 15 to 30 years, with haematological malignancies, and managed between 2000 and 2016~   "
7406|NCT03469895|"~     Efficacy of BCR Inhibitors in the Treatment of Autoimmune Cytopenias Associated with Chronic~     Lymphocytic Leukemia (CLL): A Retrospective Analysis of the French Innovative Leukemia~     Organization (FILO)~   "
7407|NCT03469882|"~     This study analyse the impact of high protein intake associated to early programed exercise~     on functional outcomes of adult intensive care patients.~   "
7408|NCT03469869|"~     This study evaluates the effect of balanced and sustainable diet application on fat~     composition, insulin resistance and inflammation marker in obese people.~      Intervention: Obese subject will receive intervention on balanced and sustainable diet~     application Control: Obese subject will receive a balanced diet application only~   "
7409|NCT03469856|"~     A multicenter, single arm, open-label trial of prasugrel monotherapy after PCI with the~     new-generation thin-strut biodegradable polymer everolimus-eluting SYNERGY® stent in patients~     with chronic stable angina~   "
7410|NCT03469843|"~     Cardiac denervation is inherent to the arterial switch (ASO) technique for the repair of~     transposition of the great arteries (TGA) and the long term reinnervation process has not~     been studied. We sought to describe the reinnervation status of adult patients long after the~     ASO, to identify areas of myocardial perfusion/innervation mismatch and to assess the~     relation of innervation status and exercise capacity.~   "
7411|NCT03469830|"~     This study explores the smart scar care pad's potential therapeutic effect in treatment~     hypertrophic scar while elucidating the adverse effects if there is any. Half of the~     participant receives traditional treatment of pressure garment and the other half receives~     the smart scar care pad together with pressure garment.~   "
7412|NCT03469817|"~     The study aims to describe bone apposition and fixation of the Trident and Trident II~     Tritatnium acetabular system in patients 1 year status post total hip replacement. We will be~     studying this by comparing magnetic resonance imaging (MRI)s taken 1 year s/p total hip~     replacement with a Trident II cup with MRI's taken of patients with the Trident Cup who had~     MRIs done at 1 year post-op.~   "
7413|NCT03469804|"~     Classic and endemic Kaposi's sarcoma (KS) are lymphangio-proliferations associated with human~     herpes virus 8 (HHV8), which treatment is poorly codified. Chemotherapies give at best 30-60%~     of transient responses. While interferon responses are frequent, this drug is often poorly~     tolerated in elderly patients. Therefore new therapies are needed. Classic KS represents an~     ideal model for evaluating new drugs since patients do not receive concomitant~     immunosuppressive regimens nor antiviral therapies.~      Pembrolizumab, an anti-PD1 monoclonal antibody has recently been shown to improve survival in~     several solid tumors. In KS few data are available on the role of PD1-PD-L1 axis. A~     significant PD-L1 expression on HHV8-associated pleural effusion lymphomas and on KS samples~     have been recently reported. Our experience in classical and endemic KS supports the role of~     this pathway with expression of PD-L1 by subpopulations of T cells but also NK cells in~     peripheral blood cells from these patients and expression of PD-L1 by tumor cells in KS~     lesions.~      In this study we will evaluate the benefit and safety profile of pembrolizumab in classic and~     endemic KS.~   "
7414|NCT03469791|"~     In many countries a majority of patients with degenerative spondylolisthesis are operated on~     with decompression plus instrumented fusion, but the scientific evidence for adding fusion is~     controversial. To evaluate whether micro-decompression alone is as good as (non-inferior to)~     decompression plus instrumented fusion, a study with data from the Norwegian Registry for~     Spine Surgery will be conducted.~   "
7415|NCT03469778|"~     The objectives of this phase II clinical study are: evaluate the efficacy, safety, patient~     adeherence and clinical applicability of a new robotic device for patients with stroke at a~     physical rehabilitation institution (Instituto de Medicina Física e Reabilitação do Hospital~     das Clínicas da Universidade de São Paulo - IMREA HCFMUSP - Rede de Reabilitação Lucy~     Montoro, unidade Vila Mariana). Methods: 10 patients with stroke diagnosis and Fugl-Meyer~     score ranging from 34 to 55 will be selected to be included in the study. After signing the~     informed consent form and being assessed by the baseline evaluations, they will undertake 18~     sessions of robotic therapy, which in its turn will be prescribed three times a week. After~     this period, the patients will be evaluated for future comparison of both the pre-treatment~     and final assessments.~   "
7416|NCT03469765|"~     New biomarkers that predict the development of renal dysfunction in patients with aortic~     surgery are urgently needed. The investigators investigate whether urinary (TIMP-2)x(IGFBP7)~     predicts postoperative Acute Kidney Injury and/or need for Renal Replacement Therapy (RRT) in~     patients after aortic surgery (including EVAR).~   "
7417|NCT03469752|"~     The purpose of this study is to evaluate the efficacy of Latino parent-focused education that~     combines enhancing parent engagement, building quality parent-child relationships, promoting~     healthy eating and physical activity, and engaging families with community resources for~     healthy foods on youth energy balance related behaviors and weight status.~   "
7419|NCT03469726|"~     Given the dismal prognosis of pancreatic cancer, detecting liver metastases early can avoid~     inappropriate therapy with the associated substantial risks, long-term hospital admissions~     and high costs, but without survival benefit. The current standard of diagnostic workup with~     contrast-enhanced CT (CECT) has a poor sensitivity (38-76%) for the detection of liver~     metastases. As more sophisticated and expensive treatment options emerge, better staging of~     pancreatic cancer is needed to avoid unnecessary procedures and select the most appropriate~     treatment strategy. New imaging modalities are available, but their value in staging of~     pancreatic cancer has not been evaluated yet. Therefore prospective imaging studies are~     necessary.~      The main aim of this study is to determine the diagnostic accuracy of contrast-enhanced~     diffusion-weighted MRI (CE-DW-MRI) in the detection of liver metastases in patients with~     pancreatic cancer compared to a reference standard of histopathology and follow up imaging.~      The study is an international, multicenter prospective cohort study (inclusion of patients~     until 138 patients with liver metastases are included, with a total maximum of 465 patients).~     Patients with pancreatic cancer will undergo additional CE-DW-MRI within two weeks from the~     CECT. CECT and CE-DW-MRI will be read independently by two radiologists. Suspected liver~     lesions on CECT and/or CE-DW-MRI will be biopsied to obtain histopathology as reference~     standard. For liver lesions without histopathologic proof of metastases a paired follow-up~     CECT and CE-DW-MRI serve as a composite reference standard. Pancreatic resection will be~     pursued in patients without proven liver or distant metastases. Patients with locally~     advanced or metastatic disease will be offered palliative treatment. Follow up CECT and~     CE-DW-MRI will be performed in all patients at 3, 6, and 12 months.~   "
7420|NCT03469713|"~     NIVES study is an ongoing phase II, single arm, multicenter study. In this trial pts received~     SBRT to one non-brain measurable lesion and concomitant NIVOLUMAB, an anti-programmed cell~     death (PD-1). Combining SBRT with NIVO may enhance the antitumor immune responses and improve~     clinical outcomes, how it was demonstrated for other solid tumors with a phenomenon known as~     the abscopal effect . It was planned to enrolled a total of 68 pts within 12 months. The~     objective of the current analysis is to describe the first report of safety profile of NIVO~     in combination with SBRT.~   "
7421|NCT03469700|"~     The incidence of obesity is steadily rising. Laparoscopic sleeve gastrectomy (LSG) is an~     innovative approach to the surgical management of morbid obesity.~      We will be discussing the effect of adding paravertebral block (PVB) in addition to general~     anesthesia (GA) vs. GA alone for post operative pain after laparoscopic sleeve gastrectomy.~   "
7422|NCT03469687|"~     The uncemented Symax hip stem is developed through optimization of the uncemented Omnifit hip~     stem. The Symax stem design combines an anatomical anteverted proximal geometry with a~     straight distal section. The proximal part is coated with a biomimetic hydroxyapatite (HA)~     coating for improved osseointegration to enhance load transfer and to minimize proximal bone~     loss. The distal part is treated with an anodization surface treatment in order to prevent~     distal bone apposition, which is expected to prevent distal loading and reduce proximal~     stress shielding. Aim of this study is to report mid-term clinical performance and evaluate~     whether the radiographic features are in line with the design principles of the Symax hip in~     an international clinical study with 5 years of follow-up.~   "
7423|NCT03469674|"~     This is prospective, multicenter, randomised phase III trial among women with endometrial~     cancer with high-intermediate risk features to investigate the role of an integrated~     clinicopathological and molecular risk profile to determine if participants should receive no~     adjuvant therapy, vaginal brachytherapy or external beam radiotherapy based on a favourable,~     intermediate or unfavourable profile as compared to standard adjuvant vaginal brachytherapy.~   "
7424|NCT03469661|"~     Current diagnostic criteria for Immune ThrombocytoPenia (ITP) are mainly based on the~     presence of low numbers of platelets, excluding other multiple causes of thrombocytopenia,~     including immunodeficiencies, constitutional or acquired thrombocytopenia, hypersplenism and~     clonal hematological disorders such as MDS, disorders lymphoproliferative and acute myeloid~     leukemia (AML), among others. The analysis complementary tests for the diagnosis of ITP~     include studies basic systematic hematology, together with autoimmune assays and~     microbiological tests, while the evaluation of bone marrow is limited to elderly patients~     and/or patients resistant to treatment. Previous research has described the development of~     Myelodysplastic Syndrome (MDS) in patients with a previous diagnosis of ITP, and even the~     presence of MDS associated with genetic background. Therefore, it is conceivable fact that a~     percentage of cases with clinical signs of ITP in the moment of appearance may actually~     correspond to the first stages of MDS development in which bone marrow cells are not~     systematically evaluated in the initial presentation.~      The anomalous immunophenotypic patterns between multiple compartments of bone marrow cells~     and peripherally blood (PB) platelets have been characterized through flow cytometry. The~     flow cytometry currently represents an important complementary tool for diagnosis of MDS that~     has shown great effectiveness and applicability in the differential diagnosis of non-clonal~     cytopenias against early MDS and for the detection of stages prior to MDS. Besides, the flow~     cytometry has made it possible to detect the presence of coexisting features related to MDS~     in patients with other malignancies hematologic conditions such as multiple myeloma, AML, and~     lymphocytic leukemia chronic. Therefore, the immunophenotypic analysis of the cells of the~     bone marrow of patients with ITP at the time of appearance would help to identify the cases~     that underlie clonal hematopoiesis MDS type. In the present study it is planned a broad~     characterization immunophenotyping of multiple compartments of bone marrow cells and PB~     platelets from patients with recently diagnosed ITP and investigate their morphological~     antecedents, in order to identify those patients who show compatible clonal hematopoietic~     patterns with MDS evident (or at risk of development), as candidates to receive most~     appropriate therapeutic methods.~   "
7425|NCT03469648|"~     Although imaging techniques are the reference standard to diagnose alveolar collapse, in the~     postoperative period and using the peripheral hemoglobin oxygen saturation (SpO2), a~     non-invasive simple and accurate test (Air-Test) was recently validated to diagnose alveolar~     collapse.~      The aim of this study is to non-invasively describe the incidence of intraoperative~     atelectasis with the Air-Test in an unselected surgical population. In addition, we attempt~     to describe the association between positive Air-Test and the patient´s preoperative or~     intraoperative variables.~   "
7426|NCT03469635|"~     Background: There is a lack of evidence on whether maternal nutritional deficiencies after~     Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) affect fetal development. The~     investigators hypothesis is that SG could induce nutritional deficiencies during pregnancy,~     as RYGB does, because of food restriction. These nutritional deficiencies may alter fetal~     growth. Methods: Women with singleton pregnancies who had at least one nutritional evaluation~     during pregnancy in our institution between 2006 and 2017 were included. The investigators~     evaluated nutritional deficiencies according to standard and pregnancy-specific norms. They~     have planned to study the relationships between these parameters and fetal growth.~     Objectives: To compare maternal nutritional parameters and neonatal outcomes after RYGB and~     SG and to assess the impact of nutritional alterations on fetal growth.~   "
7427|NCT03469622|"~     Adenoma detection rate (ADR) in colon cancer screening is most important for avoiding colon~     cancer development. Recent studies suggest a benefit of endoscopic devices attached to the~     distal tip of the colonoscope for improving the ADR. This work is the first GERMAN randomized~     controlled trial comparing standard colonoscopy with EndoRIngs-assisted colonoscopy.~      EndoRings is a new FDA approved device that is attached to the distal tip of the colonoscope.~     Better Polyp detection is suspected by flattening the mucosal folds during withdrawal~   "
7428|NCT03469609|"~     The primary objective of this study is to demonstrate that mucous fistula refeeding between~     enterostomy creation and enterostomy closure reduces the time to full enteral feeds after~     enterostomy closure compared to standard of care.~   "
7429|NCT03469596|"~     Anal canal cell carcinoma is a very rare cancer but well treated. If the morphological test~     are well established in the initial evaluation, it's not the case of the follow up evaluation~     particularly by MRI.About 1/3 of patient decline with metastatic relapse during the follow up~     of these patients.It appears that clinical regression seen precociously is a predictive~     factor of survival without relapse. But there 's no study confirming that point.~      This context takes us to evaluate if there is a predictive factor in MRI to final clinical~     result.~   "
7430|NCT03469583|"~     This is a Phase 1, single-center, open-label, three subsequent dosing periods study to~     evaluate the drug-drug-interaction (DDI), pharmaco-kinetics (PK) and pharmacodynamics (PD),~     safety, and tolerability of a single dose of EYP100a combined with ETV in healthy men and~     women dosed in the morning under fasted conditions.~   "
7431|NCT03469570|"~     The primary objective of this study is to evaluate the performance of the Acumen™ Assisted~     Fluid Management (AFM) Feature in its ability to predict a subject's fluid responsiveness.~   "
7432|NCT03469557|"~     This is a Phase 2, multi-cohort study to investigate safety, PK, and preliminary anti-tumor~     activity of the monoclonal antibody BGB A317 in combination with standard chemotherapy as~     first-line treatment. Cohorts include an ESCC cohort and a gastric carcinoma (GC) or GEJ~     carcinoma cohort that will be enrolled concurrently. The study includes a screening (up to 28~     days), treatment (until disease progression, intolerable toxicity, or treatment withdrawal~     for another reason), safety follow-up (up to 30 days following last study drug treatment),~     and survival follow-up phase.~   "
7433|NCT03469544|"~     Thyroid cancer is the most prevalent endocrine malignancy.Papillary thyroid carcinomas and~     follicular thyroid carcinomas account for 95% of all thyroid cancer cases. They are~     clinically classified as well-differentiated thyroid carcinomas due to their biological~     behavior resembling normal follicular cells and good responsiveness to surgery and~     radioiodine therapy . However, they are usually curable when discovered at early stages, but~     survival rates may be reduced from 100% in stages I and II to 50% at stage IV So,early~     detection is the key for successful treatment and reduction of mortality.~      pathological analysis by fine-needle aspiration biopsies has some limitations including~     difficulty in sampling small tumors, inconclusive diagnosis in up to 35% of patients and~     bleeding. Thus, biomarkers for diagnosis are needed.~   "
7434|NCT03469531|"~     The purpose of this phase II trial is to determine the feasibility and efficacy of~     nimotuzumab combined with concurrent chemoradiotherapy for initially inoperable locally~     advanced cervical squamous cell carcinoma.~   "
7435|NCT03469518|"~     Regular consumption of a beverage containing β-cryptoxanthin (β-Cx) and plant sterols (PS)~     has been shown to exert a synergic effect in reducing some markers of cardiovascular risk and~     bone-remodeling (formation and resorption). The present project aims to:~        -  Evaluate (by in vivo and in vitro studies) the bioavailability of added β-Cx, PS and~          galactooligosaccharides (GOS) and its stability in the beverage employed in the proposed~          study.~        -  Study the biological effect (bioefficacy) associated with the regular consumption of~          modified milk-based fruit beverages containing β-Cx, PS and GOS in post-menopausal women~          (target group) by assessing changes in inflammation, cardiovascular and bone turnover~          biochemical markers.~        -  Characterize genetic variability (polymorphisms), genetic expression and DNA oxidative~          damage in the target group as determinants of bioavailability and biological effects of~          β-Cx, PS and GOS.~        -  Evaluate the potential prebiotic effect associated to regular consumption of a beverage~          supplemented with β-Cx, PS and GOS: including in vitro studies and characterization of~          subjects' microbiota and possible microbiota changes associated to the beverage~          consumption.~   "
7436|NCT03469505|"~     To conduct a superiority trial of COPES versus standard Veterans Health Administration (VHA)~     Cognitive Behavioral Therapy Chronic Pain (CBT-CP)~   "
7437|NCT03469492|"~     To investigate whether longer-term improvement of glycemic control in poorly controlled~     diabetes patients with a 12-week intensified insulin treatment regimen will lead to decreased~     polyol pathway activity.~   "
7438|NCT03469479|"~     The purpose of this study is to evaluate the efficacy and safety of resection plus~     neoadjuvant hepatic arterial infusion chemotherapy (HAIC) compared with resection alone in~     patients with huge resectable hepatocellular carcinoma (HCC) BCLC A-B stage.~   "
7439|NCT03469466|"~     This study will assess the feasibility of remotely guided US use by individuals without~     ultrasound training to assess for normal lung parenchyma in healthy volunteers. The untrained~     operators (operators) will perform US examinations of lung under the guidance of a medical~     professional (professional) with experience in ultrasound technique. The professional will~     guide the operator step by step on how to conduct an US exam of the 'patient's' lung. Images~     will then be saved and reviewed at a later time by an ultrasound expert to determine quality~     and clinical functionality in recognizing normal lung parenchyma. This simulation will be~     analogous to an untrained US operator assessing a potentially ill patient with the assistance~     of a remotely located physician. An example of this would be an astronaut with respiratory~     distress after experiencing a rapid decompression event being evaluated by another healthy~     astronaut by US under the guidance of the flight surgeon at Mission Control.~   "
7440|NCT03469453|"~     This multiple baseline evaluation aims to test the feasibility and preliminary effectiveness~     of Internet-delivered cognitive behavioral therapy (ICBT) for adolescents with Generalized~     Anxiety Disorder (GAD).~   "
7441|NCT03469440|"~     The purpose of this study is evaluate goal-directed therapy with continuous central venous~     saturation compared to standard therapy in children undergoing cardiac surgery.~   "
7442|NCT03469427|"~     Facial nerve paralysis is a disfiguring complication which occurs in 7-10 % of temporal bone~     fractures.~      The onset of paralysis may be immediate, delayed or undetermined, the latter of which often~     occurs in unconscious patients with accompanying life-threatening complications.About one~     fourth has complete paralysis.~   "
7462|NCT03469167|"~     This is a prospective, single-blinded, randomized study to evaluate the efficacy and safety~     of CEGP003 in patients with acute peptic ulcers bleeding, compared to endoscopic epinephrine~     injection therapy.~   "
8155|NCT03460093|"~     PURPOSE: to evaluate the efficacy of superior hypogastric plexus block for pain relief after~     cesarean section~   "
7443|NCT03469414|"~     This is a cross-section correlational study that will examine the relationships between~     wheelchair speed, maneuverability, and endurance with community integration. By identifying~     which of these has the biggest contribution to community participation, the information will~     be used to justify continues therapy, to alter the focus of therapy, and to justify purchase~     of power or power assist wheelchairs when needed. Currently, therapists make the~     recommendation for a power or power assist chair based on their clinical judgement and the~     patient's experience, but there has been limited justification from the literature for these~     decisions. Finally, because the CHART measure is the gold standard in rehabilitation research~     for community integration, but has psychometric problems, we will use this opportunity to~     validate a new more psychometrically solid measure, the PART-O, against the CHART.~   "
7444|NCT03469401|"~     Invasive candidiasis has a high mortality rate, around 40%. Outcome remains tightly linked to~     the time of treatment administration. Routine microbiological techniques give results too~     lately to allow prompt antifungal therapy initiation (at least 48 hours). It is important to~     develop diagnostic tools to initiate antifungal therapy as early as possible.~      The B D glucan detection, one of the major components of the candida cell wall, can be useful~     for a early diagnosis.~      There are several techniques on the market for the detection of glucan. In Europe and~     America, the most used is Fungitell (Associated of Cape Cod, Inc).~      There is several studies about the use of such kits for fungemia. A number of studies are~     reporting evidences of a early diagnosis.~      But, in medical literature, there isn't study focused on the detection of B D glucan in~     peritoneal fluid for Candida peritonitis diagnosis.~   "
7445|NCT03469388|"~     Comparison of non-invasively obtained central blood pressure using SphygmoCor and invasively~     recorded central blood pressure in patients with an AAA that will be treated with EVAR.~   "
7446|NCT03469375|"~     FOLFIRINOX regimen is first-line neoadjuvant chemotherapies for patients with locally~     advanced pancreatic cancer (LAPC) worldwide. However, FOLFIRINOX is not well accepted in~     China because of the high prevalence of adverse events and poor tolerance. To evaluate the~     safety and efficacy of modified-FOLFIRINOX (mFOLFIRINOX) in Chinese LAPC patients and compare~     survival between LAPC patients with mFOLFIRINOX-based preoperative therapy and LAPC patients~     who underwent surgery alone.~   "
7447|NCT03469362|"~     Intracorporal urinary diversion (ICD) provides superior postoperative outcomes compared to~     extracorporal urinary diversion (ECD). The investigators' hypothesis that ICD may provide~     clinical benefit is based on principles of less bowel and ureteral handling, superior~     operating room workflow, less exposure to the external environment, and optimal visualization~     with ICD while utilizing a smaller incision compared to ECD. ICD should have less~     bowel-related complications, lower pain scores allowing patients to be discharged from the~     hospital sooner and regain functional independence more quickly.~   "
7448|NCT03469349|"~     The purpose of the study is to evaluate the efficacy and safety of actovegin in participants~     with peripheral arterial disease (PAD) Fontaine Stage IIB.~   "
7449|NCT03469336|"~     The study is a randomized, double blinded, vehicle and active comparator controlled, multiple~     dose study in subjects with chronic plaque psoriasis. The study will have approximately 15~     completers. Each subjects will receive three different topical doses of PF 06763809, PF~     06763809 vehicle, and two active comparators. These will be applied to six different~     treatment fields for 18 days. The total duration of participation in the study will be~     approximately 7 weeks (minimum) to approximately 11 weeks (maximum), including the interval~     from Screening to the Follow up phone call visit.~   "
7450|NCT03469323|"~     A safe and effective surgical environment is important for nonintubated thoracoscopic~     surgery. The investigators hypothesize that mini-dose succinylcholine can induce ultra-short~     period of apnea, by which the ventilatory responses to open pneumothorax were abolished and~     may facilitate rapid and satisfying collapse of the operated lung during nonintubated~     thoracoscopic surgery.~   "
7451|NCT03469310|"~     This research is being done to better understand and test if the investigators can minimize~     narcotic medication for controlling pain after thyroid or parathyroid surgery. This research~     will be performed at Doctors Hospital At Renaissance in the investigators clinic and the~     perioperative area.~      Participants will be randomly chosen to receive one of two options for pain management that~     the investigators are already using in the care of patients after surgery. One option~     includes a narcotic medication and one option includes a non-narcotic and a narcotic as~     needed.~      Participants will be asked to complete a form about the level of pain and how much pain~     medication was needed after surgery in the hospital and while at home. Participants will not~     have to do any additional visits to participate in this study. The investigators will obtain~     the research materials at the same time as the usual care visits around the participants'~     surgery.~   "
7452|NCT03469297|"~     This is a prospective, non-randomized, single-arm early feasibility study to assess the~     safety and feasibility of lowering intraocular pressure with the Brown Glaucoma Implant. A~     total of 10 subjects will be enrolled at a single center. Subjects will be followed for 24~     months, with the primary assessments completed 6 months after implant.~   "
7453|NCT03469284|"~     The goal of this clinical research study is to compare methylene blue (an oral rinse) to~     standard therapy to learn if one is better, the same, or worse than the other in controlling~     mucositis (mouth blisters/sores). Standard therapy may include regular analgesics (numbing~     medications) and mouth rinses.~      This is an investigational study. Methylene blue is FDA approved and commercially available~     to treat methemoglobinemia (a type of blood disorder). It is considered investigational to~     use methylene blue to treat mucositis.~      The study doctor can explain how methylene blue is designed to work.~      Up to 60 participants will be enrolled in this study. All will take part at MD Anderson.~   "
7454|NCT03469271|"~     This research is intended to begin to explore the impact of inspiratory muscle resistance~     exercise and/or 1,25(OH)2D3 for improving respiratory muscle strength in cancer patients~     (subjects).~   "
7455|NCT03469258|"~     This research study is evaluating a study drug to treat pancreatic exocrine insufficiency~     (PEI) during the first year after the diagnosis of pancreatic cancer while the participant is~     recovering from surgery and receiving adjuvant treatment.~      The study drug involved in this study is:~      -Zenpep~   "
13270|NCT03393156|"~     The purpose of this study is to investigate if an internet-based metacognitive therapy~     reduces negative metacognitions and if reductions negative metacognitions mediates reductions~     in worry.~   "
7456|NCT03469245|"~     Fenestrated endovascular repair (FEVAR) is nowadays a recognized option to treat juxtarenal,~     pararenal or suprarenal abdominal aortic aneurysms in patients at high risk for conventional~     repair. The technique consists in deploying a custom-made stent-graft (SG) inside the patient~     aorta. Part of the customization involves cauterizing a hole in SG fabric and reinforcing it~     with a Nitinol stent ring, thereby creating a fenestration for each corresponding collateral~     artery. For this reason, preoperative planning is crucial to determine adequate positions of~     fenestrations, in order to obtain perfect alignment with the collateral arteries of the~     patient. Inadequate positioning may result in failure to catheterize a collateral artery and~     subsequent organ damage, increased catheterizing time, increased irradiation dose, endoleaks…~     The current process of fenestrations positioning for fenestrated anacondaTM SG involves: (i)~     anatomical measurements on patient preoperative CT-scan by case planners using dedicated~     sizing software; (ii) designing an initial custom device scheme with its positioned~     fenestrations, created by engineers with CAD software using the above cited measurements and~     (iii) validation of fenestrations position by in vitro testing using a SG prototype deployed~     inside a transparent anatomy model (3D-printed model of patient aorta and collateral~     arteries). The main limitations of this process are the costs and long SG delivery time.~   "
7457|NCT03469232|"~     This clinical research focus on evaluating the effectiveness of Huanglian-Jiedu Decoction in~     patients with intense-exuberant stomach fire syndrome (one of the common TCM syndrome)of~     acute pericoronitis,minor recurrent aphthous stomatitis and recurrent herpes simplex~     labialis,meanwhile, exploring the pharmacological mechanism and potential biomarkers of this~     traditional formula.~   "
7458|NCT03469219|"~     Psoriasis is a chronic inflammatory and proliferative papulosquamous skin disease of unknown~     cause,overexpression of Anti Microbial Peptides is characteristic of psoriasis.~      Granulysin is a cytolytic and proinflammatory peptide that belongs to a family of~     saposin-like, lipid binding antimicrobial peptides, and localized in the granular~     compartments of cytotoxic T lymphocytes and natural killer cells,Patients with psoriasis had~     high tissue granulysin expression, which increased with increased clinical severity of the~     disease.~      The aim of the study is to measure serum granulysin level and correlate with severity of~     psoriasis and tissue level of granulysin.~   "
7459|NCT03469206|"~     Background: Intravenous thrombolysis (IVT) combined with mechanical thrombectomy (MT) has~     been proven safe and effective in patients with acute ischemic stroke (AIS) of anterior~     circulation large vessel occlusion (LVO). Despite recanalization, a considerable proportion~     of patients do not recover. The incidence of symptomatic intracerebral hemorrhage (sICH) was~     similar between bridging therapy and IVT, suggesting that this complication could not be~     attributed to the MT, but rather to pre-treatment with IVT. Meanwhile, the incidence of~     intracranial atherosclerosis stenosis (ICAS) is higher in Asians. It is not clear whether~     patients with ICAS benefit from pretreatment with alteplase or not and how ICAS modifies~     treatment effect.~      Objective: The primary objective is to assess the effect of direct MT compared to bridging~     therapy in patients with AIS due to an anterior circulation LVO. Secondary objective is to~     assess treatment effect modification by presence of ICAS.~      Study design: This is a parallel group, RCT of direct MT versus bridging therapy, using a~     non-inferiority design. The trial has observer blinded assessment of the primary outcome and~     of neuro-imaging at baseline and follow up. The trial will be executed in collaboration with~     MRCLEAN NO-IV investigators.~      Study population: Patients with AIS of anterior circulation VLO confirmed by CTA. Initiation~     of IVT must be feasible within 4.5 hours from symptom onset. Age must be 18 or over and NIHSS~     2 or more.~      Main outcomes: The full distribution of the mRS at 3 months Secondary outcomes: eTICI score~     on postprocedural DSA, NIHSS at 24 hours and 5-7 days, recanalization on CTA at 24 hours and~     infarct size on CT at 5-7 days, dichotomous clinical outcome on the mRS and mortality at 90~     days . Safety outcomes include rate of sICH.~   "
7460|NCT03469193|"~     Unicompartmental knee arthroplasty by unicompartmental prosthesis (PUC) is a treatment for~     isolated internal femoro-tibial osteoarthritis. This intervention is justified in cases of~     significant discomfort, failure of medical treatment and the absence of osteoarthritis in~     femoro tibial external and patellofemoral femoro compartments. It aims to replace the native~     internal femoral tibial articulation by a joint between two implants, without intervening on~     the other compartments. The functional results of PUC are superior and faster than those~     obtained with total knee arthroplasty (TKA). Its indications and its realization are on the~     other hand very demanding to allow an optimal functional result.~      Robotic-assisted surgery provides an excellent level of precision, which could allow better~     positioning of implants, compared to the use of a mechanical ancillary, according to the~     first published studies. The functional results and survival of these implants could also be~     improved.~      The internal PUC with mechanical ancillary is carried out for many years in the orthopedic~     surgery department of Croix Rousse. For 3 years this surgery is sometimes performed with~     robotic assistance.~      We would like to prospectively evaluate the clinical and radiological impact of~     robotic-assisted surgery when performing a Journey unicompartmental prosthesis (Smith &~     Nephew).~      The assessment of alignment during walking seems to be a paramount parameter in the results~     of the PUC and has not so far been evaluated in this type of robotic-assisted surgery.~   "
7461|NCT03469180|"~     It is reported in the literature that children with attention deficit hyperactivity disorder~     (ADHD) may have executive function deficits, impaired social functions, emotional~     dysregulation, behavioral disorders and motor impairments. Furthermore, studies have shown~     that exercise, such as acute and chronic aerobic exercises and acute whole body vibration~     training, improves executive functions and motor abilities and so it is hypothesized that~     exercise may have a potential or additional treatment option for children with ADHD.~     Neurobiological researches have already proven the effects on brain changes during exercise~     and in the case of ADHD, increasing levels of serotonin, dopamine, and norepinephrine within~     the front striatal lobes of the brain were highlighted when discussing the effects on this~     neurodevelopmental disorder. The literature emphasizes the importance of physical activity in~     children with ADHD, but there is no clarity regarding the frequency, intensity or duration of~     the exercise. Thus, the aim of this study was to investigate and compare the effects of~     treadmill training as an aerobic exercise and whole body vibration training on executive~     functions and balance in children with ADHD.~   "
46267|NCT02961270|"~     This study aims to evaluate the efficacy of icotinib, a first generation EGFR TKI, in~     non-small cell lung cancer patients harboring uncommon EGFR mutation~   "
7463|NCT03469154|"~     In a randomised non-inferiority trial the investigators examine two training interventions to~     train paediatric basic life support to laypersons: Dyad training vs Instructor led training.~      For dyad training two participants are guided by video instructions and perform exercises on~     children resuscitation manikins. The participants take turn to complete the exercises and~     provide feedback to their peer. The duration is up to 50 minutes Instructor led training of~     paediatric basic life support in instructor led courses with up to 6 participants per course~     with hands-on training on children resuscitation manikin. The duration of the courses is up~     to two hours.~      Instructor led training represents the common gold standard for training Paediatric Basic~     Life Support, however it is inflexible and uses a lot of resources. Dyad training provides a~     low cost solution with improved flexibility. Consequently a non-inferiority design is chosen~     as the benefits of dyad training with the same learning outcomes favours the dyad training~     method.~      Prior to the training both groups are informed about and have access to a website with~     videos, quizzes, pictures and text information on paediatric basic life support and foreign~     body airway obstruction management.~   "
7464|NCT03469141|"~     The goal of this module project is to establish the efficacy of a portable sensor and~     app-based biofeedback technology system for promoting effective pressure relief behaviors and~     reducing risk of pressure ulcer development among wheelchair users. In collaboration with the~     participating SCIMS centers, the investigators will conduct a randomized clinical trial of~     education and goal setting alone compared to education and goal setting combined with the~     biofeedback system (SENSIMAT®) that is commercially available.~   "
7465|NCT03469128|"~     The present research was aimed at comparing the effects of the Cognitive Processing Therapy~     (CPT) with the effects of medicine in treating the patients who have dual diagnosis PTSD &~     SUD. The present study examines the extent to which CPT is effective in treating PTSD~     symptoms for patients with PTSD and SUD.~   "
7466|NCT03469115|"~     The purpose of this study is to find out if there is a connection between a higher level of~     peptide alpha defensin in blood serum with the metabolic profile of adolescents aged 13-17.~   "
7467|NCT03469102|"~     Tumors are characterized by a great heterogeneity. Characterizing this intra-tumor~     heterogeneity is a major challenge in oncology to improve the therapeutic management and move~     towards personalized medicine adapted to each patient. However, intra-tumor heterogeneity~     remains rarely used for diagnostic purposes The discovery of an adrenal mass can occur in~     different circumstances. Detection of an adrenal mass can be done in a context of secreting~     syndrome, in the assessment of an extra-adrenal neoplasia or fortuitously when performing an~     imaging for another reason. The etiologies are numerous (cortical tumors, medullary tumors,~     metastatic lesion of a extra-adrenal neoplasia, others). The adrenal masses can be divided~     into two categories, depending on whether they are hyperfunctional or not. In patients~     without an oncological history, an adrenal mass discovered is most often a benign adenoma,~     but requires an endocrine assessment. In patients with known primary cancer, approximately~     30% of the adrenal masses are malignant.~      In all cases, the diagnostic procedure includes an imaging assessment to characterize the~     lesion and an endocrine assessment. CT scan performed without and after intravenous iodinated~     contrast agent injection is the first-line examination to assess an adrenal mass.~      18F-FDG-PET may be indicated as second-line for characterizing an adrenal mass. Adrenal tumor~     SUVmax (Standard Uptake Value) and adrenal tumor SUVmax / liver SUVmax ratio are routinely~     used to determine the malignancy of a lesion. Although very useful for assessing the glucose~     metabolism of a given lesion, these parameters do not allow assessing the heterogeneity of~     tumor uptake. The texture analysis corresponds to an analysis of the spatial distribution of~     FDG uptake, and allows, by the calculation of many indices, an evaluation of the~     heterogeneity of the tumors.~      The hypothesis of our study is that the texture parameters could have an additional~     diagnostic value to improve the performance of conventional quantitative parameters to~     determine the malignancy of a lesion.~      The objective of this study is to investigate the diagnostic value of texture indices in a~     large cohort of patients presenting an adrenal lesion~   "
7468|NCT03469089|"~     This phase Ib study aims to evaluate applicability of touchscreen-based cognitive test~     battery for assessment of ketamine-induced schizophrenia-like cognitive deficits in healthy~     volunteers. Additionally, the study aims to assess whether ketamine-induced cognitive~     deficits are reversed by modafinil using touchscreen-based test battery for testing of~     cognition.~   "
7469|NCT03469076|"~     In this study the topical use of cream with live probiotic bacteria was evaluated for its~     efficacy in reducing acne symptoms and its effect on the skin microbiota on patients with~     acne. Patients with mild to moderate acne used the probiotic cream for 8 weeks and clinical~     evaluation and sampling was done at start, 4, 8 and 10 weeks. Next-Generation Sequencing was~     used to analyze the skin microbiota of the patients.~   "
7470|NCT03469063|"~     The AFERBIO study will evaluates safety and potential benefit of AferBio® in patients with~     non-small cell lung cancer undergoing at least a second-line palliative monochemotherapy.~     AferBio® is a fermented supplement in powder form obtained through biotechnological processes~     developed in Brazil. In this double-blind placebo-controlled randomized clinical trial,~     participants starting a new palliative regimen will be allocated to AferBio® or placebo. The~     primary aim will be to compare health-related QOL scores among the arms of the study over~     time.~   "
7471|NCT03469050|"~     Colonic microbiota changes may play a key role in the pathogenesis of acute diverticulitis. A~     previous proof-of-concept study suggests that rifaximin, a low-absorbable oral antibiotic,~     may be beneficial for prevention of acute diverticulitis recurrence by modulating the gut~     microflora.~      The main objective of this study is to evaluate the safety and efficacy of two different~     doses of a delayed release formulation of rifaximin, versus placebo, for the prevention of~     recurrence of acute diverticulitis and diverticular complications in patients with a recent~     episode of acute diverticulitis.~   "
7472|NCT03469037|"~     To develop an experimental model of dyspnea by external thoraco-abdominal elastic strapping~     at rest in order to study the mechanisms involved in the relief of dyspnea by the~     administration of high flow by nasal cannula (HFNC).~   "
7473|NCT03469024|"~     The main objetive of this study is to analyze the effectiveness of a home rehabilitaton~     program vs a e-Health program. Therapeutic approach will be by electroanalgesia and exercise~     of patients with chronic low back pain.~   "
7493|NCT03468764|"~     Intraoperative hemodynamic management is important, since even mild variations in circulatory~     volume can be extremely damaging for patients.~      Minimally invasive hemodynamic monitoring are not always available or cost-effective,~     therefore management of fluids is challenging for anesthesiologists.~      This study aims to assess if, after performance of a lung recruitment maneuver (LRM),~     standard parameter's variation differs between hypovolemic and normovolemic patients.~      Patients' volemic state will be assessed with the Vigileo system. Standard monitoring values~     (heart rate, invasive blood pressure and saturation) will be registered before and after~     LRMs.~      A fluid challenge will be performed and the above mentioned parameters will be recorded~     again, after a second LRM.~      The study is a prospective observational study.~   "
7474|NCT03469011|"~     Thyroid cancers that have spread beyond the neck are not curable. About 30,000 people~     worldwide die from thyroid cancer every year. Usually, thyroid cancers get worse because the~     cancer cells become more and more abnormal through a process that is called~     dedifferentiation.~      Radioactive iodine is a standard treatment for this type of thyroid cancer. Patients will~     usually receive multiple dose of radioactive iodine over the course of their cancer journey.~     Thyroid cancers lose sensitivity to radioactive iodine as the cancer progresses/worsens with~     the process of dedifferentiation. When this occurs, the radioactive iodine treatments no~     longer work against the cancer and the cancer grows.~      Radioactive iodine enters cancer cells through transporter proteins on the outside of the~     cancer cell. The transporter proteins that are the most important are the sodium iodide~     symporters. As thyroid cancers dedifferentiate, these symporters stop working as well as they~     once did. The radioactive iodine can therefore not get into the cancer cells to cause cancer~     cell death.~      Laboratory research has shown that in thyroid cancer, a protein on the cell called platelet~     derived growth factor receptor alpha (PDGFRα) is an important for tumour growth and thyroid~     cancer dedifferentiation. PDGFRα helps cancer progression and lowers the ability of sodium~     iodine symporters to move radioiodine into cells where it would normal act to kill the cancer~     cells. PDGFRα therefore makes thyroid cells resistant to radioactive iodine.~      Imatinib is an anti-cancer drug that blocks PDGFRα function. It has been used for many years~     to treat other cancers such as leukemia. The investigators who wrote this study believe that,~     base on laboratory testing, if thyroid cancer patients are given imatinib whenafter their~     cancers have become resistant to radioactive iodine, the imatinib will block PDGFRα. This~     will let the sodium iodine symporters work again and move the radioactive iodine into the~     cancer cells. This should shrink the tumours. Imatinib would then make the thyroid cancer~     cell sensitive to radioactive iodine again. This should shrink the tumours and would mean~     longer control of the cancer, helping people with this disease live longer.~   "
7475|NCT03468998|"~     This study will evaluate the effect of allograft bone particle size on the bone quantity and~     quality following socket grafting and lateral ridge augmentation in preparation for~     endosseous implant placement.~      Pre (baseline)- and post-grafting (3 months for sockets and 6 months for edentulous ridges)~     clinical as well as 2- and 3-dimensional radiographic measurements will be used to evaluate~     the differences between sites grafted with small vs. large particle sized bone allografts.~      Histological analysis will be performed at time of surgical re-entry of grafted sites to~     place the dental implants, and assessed for differences in new bone formation between the 2~     types of grafts.~   "
7476|NCT03468985|"~     This partially randomized phase II trial studies how well nivolumab, cabozantinib s-malate,~     and ipilimumab work in treating patients with stage IV non-small cell lung cancer that has~     come back. Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the~     ability of tumor cells to grow and spread. Cabozantinib s-malate may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. Giving nivolumab, cabozantinib~     s-malate, and ipilimumab may work better in treating patient with stage IV non-small cell~     lung cancer.~   "
7477|NCT03468972|"~     IgA nephropathy (IgAN) is the most common glomerulonephritis worldwide, leading to end stage~     renal disease (ESRD) in up to 30 to 40% of patients with in a few decades after diagnosis.~     Several therapeutic options have been used in clinical practice. However, no treatments can~     completely stop the progression of IgAN. Given the pathogenic mechanism of IgAN, many~     researchers have tried to treat patients with IgAN using immunosuppression such as~     corticosteroids. To date, there have been conflicting results on the effects of~     immunosuppression in IgAN. Earlier studies from Italian groups showed that corticosteroid~     treatment significantly attenuated kidney function decline and decreased the development of~     ESRD. Since then, the beneficial effects of corticosteroids have generally been accepted for~     treatment of IgAN particularly in patients with high degree of proteinuria > 1.0 g/day~     despite maximal conservative care during 3 to 6 months. However, a recent interventional~     study by German group, known as the Supportive Versus Immunosuppressive Therapy for the~     Treatment of Progressive IgA Nephropathy (STOP-IgAN) trial, showed that immunosuppressive~     treatment in addition to intensive supportive care did not significantly improve renal~     outcome and resulted in more treatment-related side effects. Moreover, the Therapeutic~     Evaluation of Steroids in IgA Nephropathy Global (TESTING) study, another randomized~     controlled study from China, was early terminated because of safety concern related to~     corticosteroids. Interestingly, the primary composite outcome occurred significantly less in~     the methylprednisolone group as compared to the placebo group despite more serious adverse~     events in the former group. With this background in mind, we designed a multicenter~     prospective randomized controlled open-label trial; a step-wise therapeutic approach with~     corticosteroids or add-on cyclophosphamide therapy in IgAN patients with persistent~     proteinuria who have preserved eGFR of ≥ 30 ml/min/1.73 m2. A total of 19 hospitals will~     participate in this study. During 12 weeks before the enrollment, all patients will receive~     maximal supportive care including the use of RAS blockers, blood pressure control with a~     target of <130/80 mmHg, and protein restriction diet. If proteinuria does not decrease < 1.0~     g/g creatinine, patients will be randomly assigned to continue supportive care, or to receive~     corticosteroids. At 3 months after randomization, patients in the corticosteroid arm who have~     persistent proteinuria of ≥ 1.0 g/g creatinine, or fast decline in eGFR ≥ 15% from the~     baseline value, will additionally receive cyclosphosphamide during the following 3 months.~     Patients who have substantial decreased amount of proteinuria < 1.0 g/g creatinine at 3~     months will continue protocol-based corticosteroids during the same period. At 6 months after~     randomization, patients who receive add-on cyclophosphamide will switch to azathioprine as a~     maintenance therapy and those who receive corticosteroids alone will discontinue the~     treatment and will be followed up during 24 months thereafter. At least 87 subjects (a total~     of 174) would be required for each group to detect 13.5% difference in response rates between~     the two groups based on previous studies if type I error rate is 5% and type II error is 20%~     given 20% of drop-out rate during the study period. The primary endpoint is the development~     of a ≥ 30% decline in eGFR from the baseline or the onset of ESRD. This study will unveil~     conflicting results on the effects of immunosuppressive treatment in IgAN patients at high~     risk of progression.~   "
7478|NCT03468959|"~     This study is to examine the association between maternal omega3 and other polyunsaturated~     fatty acids (PUFAs) during pregnancy and autism spectrum disorder (ASD) as well as other~     non-typical development (Non-TD) in the prospective Markers of Autism Risk in Babies-Learning~     Early Signs (MARBLES) cohort.~   "
7479|NCT03468946|"~     Four basic taste perceptions and relationship with caries are poorly investigated in children~     as compared to adults.~      The aim of this study was to evaluate salty, sweet, bitter and sour taste perceptions of~     school children and compare them with demographic, clinical, microbiologic and biochemical~     caries-risk factors.~   "
7480|NCT03468933|"~     The purpose of this prospective randomized clinical trial is to compare two currently~     accepted standard-of-care treatment strategies: Medical thoracoscopy as compared to~     instillation of intrapleural tissue Plasminogen Activator (TPA) and human recombinant~     Deoxyribonuclease (DNase) for the management of empyema or complicated parapneumonic effusion~     (CPPE) in adults.~   "
7481|NCT03468920|"~     The current study proposes to examine whether there is a significant difference in patient~     outcomes related to the administration route of preoperative Acetaminophen. Specifically, the~     study will compare outcomes of surgical patients who receive IV Acetaminophen with surgical~     patients who receive oral Acetaminophen.~   "
7482|NCT03468907|"~     Mother-to-child transmission (MTCT) is the most common mode of perpetuating chronic hepatitis~     B virus (HBV) infection in endemic countries. Many studies have demonstrated antepartum~     anti-viral therapy (AVT) is a advisable option to reduce mother-to-child transmission and the~     risk of vaccination breakthrough in infants who received passive-active immunoprophylaxis.~     However, several controversies over antiviral treatment have not been resolved, that is,~     optimal duration, effect of postpartum therapy, and risk of postpartum alanine~     aminotransferase (ALT) flare after withdrawal. Will the risk of postpartum hepatitis flares~     increase after short-term AVT in late pregnancy for maternal HBV infection is discontinued?~     Is there any correlation between postpartum hepatitis flares and withdrawal time? Will the~     proportion of postpartum flares be reduced if extending the duration of AVT after delivery?~     There is an urgent need in this area. This study mainly investigates the safety of antiviral~     therapy in preventing HBV mother-to-child transmission in pregnant women after~     discontinuation.~   "
7483|NCT03468894|"~     Sitting for long uninterrupted periods of time can increase risk of heart disease, diabetes~     and early death, even if you take part in the United Kingdom government guidelines for~     physical activity of 21/2 hours per week of exercise. Effective interventions to reduce the~     risk of these diseases are therefore needed. The aim of this study is to examine the effects~     of regularly breaking up sitting time with light intensity treadmill desk walking among~     office workers on health markers, sitting time and physical activity. If using a treadmill~     desk leads to benefits in these disease risk markers then this could be an effective strategy~     to improve employee health in the workplace.~      Participants will be randomly assigned to the intervention group or the control group. After~     baseline activity and health measures, they will take part in the study for 4 weeks.~      Intervention group: Participants will have a treadmill desk placed in their office or a~     nearby location and will be asked to walk while working on the treadmill desk continuously~     for 20 minutes at a self-selected slow pace each hour for a minimum of 6 hours per shift.~     There will be one treadmill desk between 2-3 people.~      Control group: Participants will be asked to work as usual at their regular workstation with~     no changes in their physical activity and dietary habits.~      Sitting time and physical activity will be measured at baseline and during the last week f~     the intervention. A range of health and psychological measures will be taken at baseline and~     post-intervention.~   "
7484|NCT03468881|"~     This study (FORECAST 2) builds upon the work of the successful pilot study (FORECAST) that~     found some evidence that breast cancer patients' fears of cancer recurrence (FCR) were~     sensitive to the communication exchange with therapeutic radiographers during weekly review~     appointments. The aim of FORECAST 2 is to co-design and pilot a communication training~     package for therapeutic radiographers to help them manage emotional talk with breast cancer~     patients who are undergoing treatment, with the intention to minimise patients' development~     of FCR during this trajectory.~   "
7485|NCT03468868|"~     This study aims to compare the effectiveness of an exercise program delivered in a~     conventional facility-based format versus a telerehabilitation format, which takes place in~     the home. Exercise can improve mobility and perhaps decrease the rate and extent of~     disability in people with MS. Evidence shows that traditional, facility-based exercise~     training may help people with MS consistently participate in exercise or to exercise at a~     higher, more intense level. Despite this evidence, lack of access to facility-based exercise~     programs may make it difficult for people with MS to engage in exercise.Telerehabilitation~     (telerehab) has great potential to overcome challenges associated with facility-based~     programs. Telerehab can include videoconferencing, remote monitoring of signs and activity,~     and dissemination of specialized and individualized information via electronic mechanisms,~     such as smartphones and computers. Both facility-based and telerehab exercise training have~     yielded positive results in people with MS, but have not been compared head-to-head. The~     current study will fill this gap in the evidence base and compare the outcomes of delivering~     the same exercise interventions in a facility or in the home/community using a telerehab~     approach. The interventions are designed to be identical in content, with the only difference~     being the mode of training delivery.~   "
7486|NCT03468855|"~     The main objective of this study is to assess the safety, tolerability and efficacy of~     ATI-50002 Topical Solution, 0.46% in subjects with non-segmental facial vitiligo.~   "
7487|NCT03468842|"~     Exploratory, phase I study to evaluate the clinical efficacy of Streptococcus dentisani CECT~     7746 in the risk reduction of caries. Patients who meet the inclusion and exclusion criteria~     will be randomized and receive the corresponding treatment. The study will follow a~     randomized design, with two groups in parallel (placebo group and probiotic group) of~     prospective, double-blind follow-up, for a period of 45 days. The present study will be~     conducted in a single center and will include a total of 70 patients. The present study has a~     double main objective:~        -  Evaluate whether the administration of the probiotic S. dentisani CECT 7746 alkalizes~          the basal pH of saliva.~        -  Test the safety and tolerability of the probiotic~      Secondary~        -  Evaluate other microbiological parameters associated with caries risk such as the~          presence of microorganisms such as S. mutans.~        -  Evaluate the presence in the mouth and colonization capacity of S. dentisani.~        -  Evaluate the lactic acid and the pH of the ex vivo plate before and after the~          administration of a sugar solution~        -  Evaluate the salivary pH before and after the administration of a sugar solution~        -  Evaluate the salivary pH before brushing with water.~        -  Evaluate the buffer capacity of saliva~   "
7488|NCT03468829|"~     The primary objective of the study is to evaluate the antiviral effect and safety of inhaled~     ALX-0171 in adults diagnosed with respiratory syncytial virus (RSV) respiratory tract~     infection after hematopoietic stem cell transplantation (HSCT).~      The secondary objective is to assess the clinical activity, pharmacokinetics (PK), virology,~     and immunogenicity of inhaled ALX 0171 in adults diagnosed with RSV respiratory tract~     infection after HSCT.~   "
7489|NCT03468816|"~     Ulcers, such as leg wounds (venous, arterial and combinations) and diabetic foot ulcers, have~     become a challenge for healthcare around the world. In this study we aim to assess the~     combination of a moisture sensor on a clinical established super absorbent wound dressing.~     Six patients will be recruited in the study and two different sensors will be compared in a~     cross-over design. After inclusion the leg ulcer will be dressed with a sensor of type A or~     type B. The patient will then be asked to come back at a day that the clinician estimates as~     proper. During the first revisit to the wound care site the ulcer will be assessed before~     again dressed but now with the other sensor type than first chosen (type A or B. During the~     second revisit the ulcer will be assessed and then dressed with the first chosen sensor type~     (A or B). During the third revisit the ulcer will be assessed.~      The study will be done accordingly to ISO 14155 and the declaration of Helsinki.~   "
7490|NCT03468803|"~     Candida species are both known to colonize physiologically mucosal surfaces in the human body~     without causing signs or symptoms of infection and to cause a wide variety of diseases,~     including mucocutaneous infections and potentially fatal invasive infections of the~     bloodstream or organs. Throughout the past decades, invasive fungal infections (IFIs) are of~     increasing importance even in non-neutropenic patients who are in need of treatment in~     intensive care units (ICU) or have undergone major surgeries. Several factors like parenteral~     nutrition, central venous catheters, broad spectrum antibiotics admission, disturbance of~     gastrointestinal mucosa integrity have been associated with an increased incidence of IFIs.~     Positive testing for 1,3-ß-D-Glucan (BDG) in serum is widely used to assess invasive fungal~     infections. It detects circulating BDG, which is part of the fungal cell wall of clinical~     relevant fungi such as Candida spp. and Aspergillus spp..~      The issue of BDG kinetics after intestinal mucosal damage (e.g. mucositis or gut surgery) is~     poorly understood. Intestinal mucosal damage is characterized by a loss of integrity of the~     intestinal mucosal barrier and increasing translocations of bacterial and/or fungal~     commensals of the gastrointestinal tract.~      In abdominal surgery a key concern in serum BDG kinetics is the potential introduction of BDG~     from surgical sponges and gauze or mucosal damage due to surgical damage of the mucosal~     integrity. Compared to open abdominal surgery in laparoscopic abdominal surgery sponges and~     gauze are rarely used. As life-threatening intraabdominal candidiasis occurs in 30 to 40% of~     high-risk abdominal surgical intensive care unit (ICU) patients it is of utmost importance to~     obtain reliable BDG values for diagnosis or exclusion of invasive candidiasis.~   "
7491|NCT03468790|"~     This is a multi-centre, randomized, double-blind，placebo parallel-controlled phase III study~     to evaluate the efficacy and safety of CMAB007 (recombinant humanized anti-immunoglobulin~     E(IgE) monoclonal antibody for injection) to treat asthma patients who remain not adequately~     controlled despite Med/high ICS plus LABA in China. Following a screening period of up to 2~     weeks and run-in period of 4 weeks, randomized patients will enter a 24-week treatment period~     with CMAB007 or placebo. Efficacy and safety will be assessed at 4-week intervals during the~     treatment period.~   "
7492|NCT03468777|"~     The main purpose of study is to evaluate the effect of multiple-dose administration of~     lansoprazole (and optional: time-separated single dose administration of ranitidine) on the~     pharmacokinetics (PK) of JNJ-63549109 after a single dose of lumicitabine in healthy adult~     participants, under fasted (and optional: fed) conditions.~   "
7494|NCT03468751|"~     The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended~     Phase 2 dose (RP2D) of humanized anti-PD-1 monoclonal antibody, HLX10, in patients with~     advanced or metastatic tumors refractory to standard therapy. This study will also evaluate~     the pharmacokinetics, pharmacodynamics, immunogenicity and anti-tumor effect of HLX10 and~     explore the potential prognostic and predictive biomarkers.~   "
7495|NCT03468738|"~     The aim of the CeKATU study is to describe the transfusion practices in patients undergoing~     major surgery in Turkey. The transfusion rates of red blood cells (RBC), fresh frozen plasma~     (FFP) and platelets; the transfusion predictors and transfusion related patient outcomes are~     investigated.~   "
7496|NCT03468725|"~     The XEN1101 Phase 1 clinical trial is a randomized, double-blind, placebo-controlled study~     that will eventuate the safety, tolerability, pharmacokinetics (PK) and effects on~     transcranial magnetic stimulation (TMS) of oral doses of XEN1101 in healthy male subjects.The~     TMS procedure is designed to demonstrate delivery of XEN1101 into the central nervous system~     and to observe a change in cortical excitability as measured by EEG and/or EMG activity. It~     is estimated there will be approximately 15 subjects in the planned study.~   "
7497|NCT03468712|"~     Gastric cancer is the third major cancer of global cancer-related death. In China, the early~     diagnosis rate of gastric cancer is relatively low, and most patients are with locally~     advanced tumor stage. The neoadjuvant chemotherapy (NAC) can bring the survival advantage for~     gastric cancer patients with locally advanced tumor stage. The primary goal of NAC is to~     control the micrometastasis and/or progression of the primary lesion in order to improve~     potential of radical gastrectomy. NAC is recommended for patients with locally advanced stage~     (T2-4Nx) according to the latest NCCN Gastric Cancer Guidelines.~      Laparoscopy distal gastrectomy (LDG) can achieve a better postoperative short-term recovery~     than the traditional open distal gastrectomy (ODG), which can reduce the intraoperative blood~     loss and to shorten the postoperative hospital stay. Therefore, Enhanced Recovery After~     Surgery program of gastric cancer surgery recommends the use of minimally invasive surgery.~     For long-term survival outcomes, there is limited evidence supported that laparoscopic~     gastrectomy is comparable open gastrectomy. Therefore, due to the lack of high-quality~     prospective clinical trial results, whether advanced tumor is suitable for laparoscopic~     surgery is still controversial. Therefore, some multi-center prospective randomized~     controlled trials have been carried out, compared safety and long-term survival outcome~     between laparoscopic and open gastrectomy in locally advanced gastric cancer patients.~     CLASS-01 trials reported that for locally advanced gastric cancers, laparoscopic D2 distal~     gastrectomy is safe and feasible.~      Patient's surgical tolerance and stress response may be inhibited after the treatment of NAC.~     The aim of this trial is to confirm the safety of laparoscopy distal D2 radical gastrectomy~     for the treatment of after neoadjuvant chemotherapy gastric cancer patients (cT3-4a, N+, M0)~     in terms of postoperative complications.~   "
7498|NCT03468699|"~     The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow~     mononuclear stem cell transplantation for Children Suffering from Liver Cirrhosis Due to~     Biliary Atresia~   "
7499|NCT03468686|"~     This study aims to compare the effectiveness of rTMS on the reduction of anhedonia and~     rumination and their associated neural networks. In a randomized double-blind trial, 45~     patients with major depressive disorder (MDD) in Atieh Clinical Neuroscience Center are~     assigned to two groups. The first group receives bilateral rTMS for 10 sessions on DLPFC; the~     second group receives sham rTMS for 10 sessions. In this group, the stimulation parameters~     are similar to that in the actual rTMS group, except that the coil angel is 90° and~     perpendicular to the head. Anhedonia symptoms will be measured by the Snaith-Hamilton~     Pleasure Scale (SHAPS), and rumination symptoms will be measured by the Ruminative Responses~     Scale (RRS) in the baseline and in the end of 10th session. In order to investigate neural~     networks associated with Anhedonia and rumination, EEG of patients will be recorded at the~     first session and at the end of the treatment.~   "
7500|NCT03468673|"~     To develop and validate a specific questionnaire of sexual quality of life in several~     languages and cultures (France, Brazil, Australia) allowing a meaningful and comprehensive~     assessment of the sexuality of patients infected with HIV and HCV; Propose reference scoring~     for sub-populations.~   "
7501|NCT03468660|"~     Older people experience great difficulty understanding speech, especially accented English,~     and this problem is expected to increase with the influx of immigrants who provide services~     to the elderly population. The research examines the underlying factors that contribute to~     older listeners' difficulty understanding accented speech, including those associated with~     age-related hearing loss, changes in processing in auditory pathways in the brain, and~     general cognitive decline. The investigation also evaluates the efficacy of training~     strategies to improve understanding of accented English by older people. Outcomes of this~     research are expected to improve communication between senior citizens and those with whom~     they interact daily, and thereby improve quality of life for the older segment of the~     Nation's population.~   "
7502|NCT03468647|"~     The object of the present project is to promote the prevention of disability by providing 1)~     a feedback and motivational coaching to the user, 2) relevant clinical parameters to the~     healthcare professionals in order to support the patient's follow-up, and 3) supporting the~     detection of preliminary signs of functional loss. The technical solution will contain~     wearable (e.g. smart insole) and ambient unobtrusive devices (e.g. weigh scale including~     balance analysis), and analysis and diagnosis assistance software. The devices transmit~     wirelessly the collected data to a remote server through a tablet. Data will then be~     available remotely for consultations by users (i.e. patients or physicians). The clinical~     evaluation will be a multi-phased design with a first living lab evaluation followed by a~     real life home trial to finalize the evaluation. Comprehensive assessments will be conducted~     to highlight the feasibility and acceptability.~   "
7503|NCT03468634|"~     To develop and endoscopic Raman spectroscopy probe for delivery down and channel in an~     endoscope to make near instant assessments of the condition of the oesophagus without the~     need for expensive and distressing tissue removal (biopsies).~   "
7504|NCT03468621|"~     This study aims to asses whether the rate of surgical wound infections in vascular surgery~     procedures involving exposure of the proximal femoral artery can be reduced using a different~     skin closure technique.~   "
7516|NCT03468465|"~     -  To determine if the T-PTNS is not inferior in the short term (3 months) to one of the~          usual pharmacological treatments (Solifenacin) in the treatment of hyperactive bladder~          syndrome and with respect to the percentage of patients that improve 50% any of the 3~          signs (Urinary frequency, diurnal / nocturnal frequency, urgency and urinary~          incontinence).~        -  To determine prognostic factors associated with insufficient improvement (less than 50%~          in the 3 main signs of hyperactive bladder syndrome (urinary frequency, urgency and~          urinary incontinence frequency) after treatment with T-PTNS and Solifenacin.~   "
10426|NCT03430336|"~     This study assesses whether an electronic medication management support system improves~     quality, safety, and cost-effectiveness of the drug therapy in adult patients with~     polypharmacy at fifteen (T1) months from baseline compared to usual care.~   "
7505|NCT03468608|"~     The quality of care associated with medical procedures, such as procedural sedation, has~     historically been assessed from the perspective of the healthcare professional, wherein the~     appropriateness of the services provided and the skill with which this care was performed~     were considered. However, more recently, the perspectives of consumers of healthcare services~     (i.e. the patients) have also been sought in the form of patient satisfaction. A review of~     the literature shows that patient satisfaction is routinely assessed when determining the~     effectiveness of sedation; however, it is less frequently assessed as the primary outcome. In~     child-specific, validated studies, limitations are noted with respect to being validated in a~     language other than English and failing to encompass a variety of procedures. As a result,~     these validated tools are not appropriate for use with pediatric populations undergoing~     procedural sedation in North America, nor are these validated tools amenable to comparison~     with our proposed tool.~   "
7506|NCT03468595|"~     The aim of this trial was to establish the clinical efficacy of Listerine and chlorhexidine~     (CHX) when used as a cooling agent with ultrasonic instrumentation, on periodontal parameters~     and halitosis.~      Ninety patients with periodontal disease participated for the study. Individuals were~     randomly selected to a control and test groups. At baseline, all subjects completed a~     questionnaire and carried out an examination. Standard periodontal outcome variables were~     assessed. For both groups, the plaque index (PI), gingival index (GI), pocket depth (PD),~     bleeding on probing (BOP) and clinical attachment level (CAL) scores were enrolled at~     baseline and after 30 days. Volatile sulphur compound (VSC) levels were evaluated by a~     Halimeter (Interscan Corp., Chatsworth, CA, USA) at baseline (T0), immediately after~     treatment (T1), and at 7 (T2), 14 (T3) and 30 days (T4).~   "
7507|NCT03468582|"~     The conventional way to control HIV infection is the usage of a drug cocktail capable of~     suppressing the viral replication cycle, commonly known as antiretroviral therapy (ART).~     Despite effective ART it is not possible to eradicate HIV. The virus hides in particular~     cells to form the latent HIV-reservoir.[1-9] Studies that emphasise on revealing hidden~     reservoirs would aid in designing novel therapeutic strategies for controlling HIV infection.~     Molecular imaging by SPECT/CT has the potential to reveal hidden reservoirs of HIV virus that~     are not eliminated by currently used drugs capable of suppressing and thereby controlling the~     viral replication cycle in HIV infected patients. New approaches, necessary to prevent and~     treat HIV-1 infection, are gradually emerging. A new generation of highly potent broadly~     neutralizing antibodies (bN/Abs) may represent a promising approach to combating HIV-1~     infection.[10] The broadly neutralizing antibody 3BNC117 antibody that can mimic human CD4~     binding targeted against the HIV gp120 envelope protein has been tested in various clinical~     trials.[11-14] It has found to be safe and effective in reducing viraemia and to improve host~     humoral responses in HIV-1 infected individuals, and to have effect on viral rebound in~     patients who are kept off antiretroviral treatment briefly for experimental purpose.~      Imaging of simian immunodeficiency virus (SIV) infection by PET/CT has been successfully~     performed in nonhuman primates with a 64Cu-labeled SIV gp120-specific antibody called~     7D3.[15] This study aims to use a similar approach in human with the 3BNC117 antibody. The~     3BNC117 antibody has been successfully radiolabeled with iodine 123. The half-life of this~     radioisotope is appropriate for antibody imaging in nuclear medicine. Radiolabeled 123I~     3BNC117 was shown to keep a good immunoreactivity for gp120. By using state of the art SPECT~     scanner a semi-quantitative image will be obtained. In addition, the absence of any chelator~     and the well known use of iodine-123 in clinic make it suitable for human intervention.~      No HIV imaging in human has been achieved yet, which is however fundamental to understand~     some key steps in the pathogenesis of HIV-induced immunodeficiency. This research opens~     promising opportunities for drug and vaccine development. Indeed, identification of virus~     reservoirs in treated patients would facilitate the development of strategies for eradicating~     these reservoirs or for extending latency period.~   "
7508|NCT03468569|"~     RELATIONSHIP OF FUNCTIONAL MOVEMENT ANALYSIS WITH INJURY HISTORY AND ATHLETIC PARAMETERS IN~     HANDBALL ATHLETES~      Abstract Objectives: Handball is a popular sport in many countries. There is lack of~     knowledge about handball athlete's functional movement capacity. The aim of this study is to~     investigate the Functional Movement Screen (FMS™) scores, to evaluate the injury risks of~     handball athletes and to determine its relationship with athletic performance.~      Design: Observational study. Methods: A total of 51 professional handball players in Turkey~     were included in this study. The sport-specific features and demographic data were recorded.~     The functional movement analysis was performed and agility and balance and force were~     evaluated.~   "
7509|NCT03468556|"~     The primary objective of the study is to compare the changes in serum ALT level among~     patients with non-alcoholic steatohepatitis (NASH) following 3-month treatment of 800 mg~     SNP-610 or the placebo. The secondary objectives will be to compare the changes in liver fat~     fraction, other liver function tests, cytokeratin-18 (CK-18) fragment level and adverse event~     / serious adverse event rates among the interventional and placebo arms.~   "
7510|NCT03468543|"~     To assess how long modified release (MR) memantine hydrochloride prototype capsule~     formulations stay in the stomach as determined by magnetic resonance imaging (MRI).~   "
7511|NCT03468530|"~     efficacy of endoscopic ablation of Hunner lesions in patients with IC/BPS and the~     characteristics of HLs based on a long-term follow-up~   "
7512|NCT03468517|"~     The patients were randomized into Bathe and Control groups by using the closed envelope~     technique. Demographic data and pre-examination anxiety scores State- Trait Anxiety Inventory~     (STAI) are recorded as entrance STAI for all patients. Then they had routine preoperative~     evaluation. During these procedures, Bathe method was applied to the Bathe Group whereas it~     was not applied to the Control Group. After that post-examination, STAI scores were recorded~     as exit STAI and the patients were later asked questions about their contentment.~   "
7513|NCT03468504|"~     This is a pilot randomised controlled trial investigating a combination of mirror therapy and~     treadmill training for the rehabilitation of lower limb impairment following a stroke. This~     study has been conducted as part of a PhD qualification at the Institute of Technology Sligo~     in Ireland with all therapy sessions taking place at the institute. The study was conducted~     in conjunction with Sligo University Hospital and it attained ethical approval through the~     relevant University Hospital Ethics Committee.~   "
7514|NCT03468491|"~     The study purpose is to investigate the effectiveness of a program combining biomechanical~     taping with lower extremity neuromuscular exercises for runners with patellofemoral pain~     syndrome (PFPS) and hallux valgus~   "
7515|NCT03468478|"~     This study was designed to compare 3 immunosuppression regimens: sirolimus and tacrolimus~     versus everolimus and tacrolimus versus mycophenolate and tacrolimus.~      The primary outcome is the incidence of cytomegalovirus infection / disease, a relevant~     medical need in the absence of pharmacological prophylaxis.~   "
7682|NCT03466294|"~     This study is being done to determine if treatment with azacitidine and venetoclax is~     effective treatment for elderly patients with acute myeloid leukemia (AML) who have not~     received previous treatment. Azacitidine and venetoclax will be given as induction treatment~     followed by venetoclax maintenance treatment for patients who respond to the induction~     treatment.~   "
7517|NCT03468452|"~     MYASTHENIA GRAVIS (MG) is an autoimmune disease characterized by varying degrees of muscle~     weakness and fatigability worsened with exertion and relieved with rest。Thymectomy plays an~     important role in the management of these patients because a consistent association between~     myasthenic and thymic pathology has been recognized.The need for prolonged mechanical~     ventilation in these patients after thymectomy is determined by their preoperative condition~     and various perioperative risk factors. Leventhal et al proposed a preoperative scoring~     system to predict the need for postoperative mechanical ventilation in myasthenic patients~     undergoing thymectomy based on the following 4 criteria: duration of MG, chronic respiratory~     disease, dose of pyridostigmine, and vital capacity. However, some investigators discovered~     that the Leventhal criteria may not be the sole benchmark and that other criteria such as~     severity of myasthenia,history of myasthenic crisis, and presence of thymoma may be more~     important in predicting the necessity for prolonged mechanical ventilation after thymectomy.~     Naguib et al described multivariate determinants of the need for postoperative ventilation~     after thymectomy in MG patients predominantly on the basis of pulmonary function tests. In~     addition, the prevalence and presentation of MG may be variable among different ethnic~     groups. However, there are very few large studies investigating the determinants of prolonged~     mechanical ventilation after thymectomy. The authors describe the parameters associated with~     prolonged mechanical ventilation after trans-sternal thymectomy at their institution.~   "
7518|NCT03468439|"~     A pre-post descriptive study was performed to examine the immediate effects of ultrasound~     (US) guided femoral nerve block with phenol (UGFNBwP) in managing lower limb spasticity of~     individuals with traumatic spinal cord injury (SCI).~   "
7519|NCT03468426|"~     PART 1:~      Primary objective:~      - To determine the Recommended Phase 2 Dose (RP2D) of BI 836880 in combination with BI 754091~     in check point inhibitor naïve patients with locally advanced or metastatic non-squamous~     NSCLC who progressed during or after first line platinum based treatment.~      Secondary objective:~        -  To provide safety data~        -  To evaluate the basic pharmacokinetics of BI 836880 and BI 754091 during combination~          therapy after the first and fourth infusion cycle.~      PART 2:~      Primary objective:~      - To assess anti-tumour activity of BI 836880 in combination with BI 754091 in check point~     inhibitor naïve patients with locally advanced or metastatic non-squamous NSCLC who~     progressed during or after first line platinum-based treatment .~        -  Cohort A: Patients with locally advanced or metastatic non-squamous NSCLC with low PD-L1~          expression (PD-L1 expression in 1-49% of tumor cells)~        -  Cohort B: Patients with locally advanced or metastatic non-squamous NSCLC with high~          PD-L1 expression (PD-L1 expression in ≥ 50% of tumor cells)~      Secondary objective:~        -  To provide preliminary safety data and the secondary measures of clinical efficacy~          including disease control (DC), duration of objective response (DoR), progression free~          survival (PFS), and tumour shrinkage~        -  To evaluate the basic pharmacokinetics of BI 836880 and BI 754091 during combination~          therapy after the first and fourth infusion cycle.~   "
7520|NCT03468413|"~     This is a Phase I, first-in-human, double-blind, single-centre, randomised,~     placebo-controlled, single and multiple oral dose study in healthy subjects conducted in 4~     parts (Part 1; Single-ascending dose, Part 2; Food-effect evaluation, Part 3; Gender-effect~     evaluation, Part 4; Multiple-ascending dose).~   "
7521|NCT03468400|"~     The study aims to develop and test a user-friendly, accessible approach to sleep assessment~     which can function as an initial triage of targeted sleep conditions, such as insomnia,~     insufficient sleep syndrome, sleep apnea syndromes/snoring, and circadian sleep/wake~     disorders, within the clinical and community population. Specifically, this study will test~     the validity and reliability of a self-rated, digitized, and cost-effective diagnostic~     measure with sufficient sensitivity to accurately assess/diagnose common sleep conditions~     and/or risk for these conditions. Such an approach, would allow for faster assessment of~     common sleep conditions and disorders, and provide clinical knowledge to the individual, the~     physician, and if required insurance companies, as to those persons who need more immediate~     attention or treatment for their sleep condition.~   "
7522|NCT03468387|"~     It is prospective randomized comparative clinical trial comparing primary urethral~     realignment vs. suprapubic cystostomy in initial management of pediatric pelvic fracture~     urethral injury regarding:~        1. The success rate after initial intervention.~        2. The need for urethroplasty in the failed realignment group and cystostomy group.~        3. The success rate of urethroplasty in the failed realignment group and cystostomy group.~   "
7523|NCT03468374|"~     Role of SPECT/CT in detection of sentinel lymph node in patients with breast cancer that is~     in early stage with small mass with no nodal or distant metastasis using radioactive material~     nannocolloid that can change surgical approach~   "
7524|NCT03468361|"~     The use of alternative therapy, particularly herbal treatment is becoming prevalent among~     patients. Many herbs are in-use for various ailments such as diabetes, digestive problems,~     fever, hepatitis and hypertension etc. The common belief is, herbs are safe and easy to~     access as compared to conventional therapy, however, most of the studies reported different~     side effects which may be toxic at times. These adverse effects are mostly due to incorrect~     use or lack of patient education.~      Parsley is a plant with antioxidant, diuretic and antimicrobial properties. Literature~     reported use of parsley as a diuretic by different communities in throughout the world. In~     vitro studies in animal have also reported the diuretic effect as well as proposed mechanisms~     for the use of parsley as diuretic however none of the studies have been conducted to~     investigate the diuretic effect of parsley in humans. This study aims to evaluate the~     diuretic and hence antihypertensive effect of parsley in hypertensive patients.~   "
7525|NCT03468348|"~     The objective of this study is to evaluate the analgesic effect of oral dulexitine tablet~     (administered 2 h before surgery) as well as the ideal dose for acute postmastectomy pain.~   "
7526|NCT03468335|"~     Second-line therapy with Nal-IRI after failure gemcitabine/nab-paclitaxel in advanced~     pancreatic cancer - predictive role of 1st-line therapy~   "
7551|NCT03468010|"~     Cervical cancer with pelvic or para-aortic node involvement has a poor prognosis. Despite~     low-quality data, the routine practice to treat these patients is radiation with concurrent~     cisplatin. The aim of this study is to compare systemic chemotherapy with observation after~     radiation with concurrent cisplatin of cervical cancer ( with pelvic or para-aortic node~     involvement) for incidence of adverse events and local recurrence rate.~   "
7527|NCT03468322|"~     Inherited epidermolysis bullosa (EB) is a genetic skin disorder characterized by skin~     fragility and recurrent blister formation. More and more evidence has suggested that the skin~     lesions initially caused by genetic mutations may be further aggravated by inflammatory~     responses. Several reports showed successful alleviation of EB symptoms upon treatment with~     immunomodulatory therapies. Modulation of proinflammatory cytokine IL-1β has shown promising~     results in alleviating epidermolysis bullosa simplex (EBS), a major subtype of inherited EB,~     by downregulating IL-1β-mediated JNK/MAPK signaling pathway. This data further supports the~     potential of using cytokine modulators to treat EB.~      AC-203, a topical formulation, can inhibit the production and activity of IL-1β,~     down-regulate IL-1β receptors, and increase IL1β-receptor antagonist (IL1-Ra) expression. In~     addition, AC-203 has been reported to inhibit anti-BP180 autoantibody-induced IL-6/IL-8~     upregulation in cultured keratinocytes and LPS-induced IL-6 upregulation in cultured~     macrophages. Furthermore, AC-203 was also found to inhibit the formation of NLRP3~     inflammasome, which plays essential roles in induction of caspase-1-dependent pyroptosis and~     release of inflammatory cytokines IL-1β and IL-18. These studies demonstrated the cytokine~     modulatory properties of AC-203 and pointed out the possible application of AC-203 in a~     variety of inflammatory diseases.~      This study is designed to test the efficacy, safety, tolerability, and pharmacokinetics of~     AC-203 ointment (vs. placebo) in patients with inherited EB.~   "
7528|NCT03468309|"~     Use of polypharmacy has significantly increased over the past two decades, which has unproven~     clinical benefit and is associate with an increased the risk of adverse side effects.~     Pharmacogenetic assays, such as the Genecept® Assay, have the purported benefit of being able~     to predict response(s) to specific medication based on genetic markers. Thus, this study is a~     12-week open-label, naturalistic study of the provision of pharmacogenetic testing and a~     computerized decision tool for providers to determine the potential efficacy of the assay to~     reduce polypharmacy and improve patient outcomes.~   "
7529|NCT03468296|"~     This study is designed to evaluate the safety and efficacy of every 2 week intravitreal~     aflibercept injections in a population of neovascular AMD patients that have demonstrated~     refractory subretinal fluid with or without intraretinal fluid despite prior monthly~     intravitreal aflibercept treatment.~   "
7530|NCT03468283|"~     Since diabetes is a chronic disease closely related to unhealthy lifestyle, the improvement~     and management of living habits are as significant as medical care with regard to the~     disease. In addition, this is regarded as the most effective method for prevention and~     treatment of diabetes. However, many diabetic patients are now reported to lack proper~     management in Korea with a low level of compliance with treatment instruction. In that sense,~     it is urgently necessary to develop a program in which diabetic patients are able to~     effectively manage their own blood glucose at home, and to grasp the real state of self-blood~     glucose measurement. Accordingly, a system to manage diabetes using electronic equipment such~     as mobile phone or the Internet is currently being developed and studied, for the effective~     management of diabetes with the help of highly evolving information technology. These~     investigators have developed a diabetes management program that provides an optimal solution~     based on a mobile device and software, so that individual patients can undergo a regular~     blood glucose test and achieve improvement and constant management of living habits by being~     properly informed of how to manage diabetes. This clinical study was designed to evaluate the~     effectiveness and efficacy of the application through the comparison between usual medical~     care and additional care using the smartphone application, targeting patients with type 2~     diabetes who lack blood glucose control. This study is targeted at the subjects who are being~     treated at this hospital's endocrinology, are using a smartphone, and voluntarily signed the~     informed consent form (ICF). The subjects who pass the subject eligibility evaluation provide~     information regarding assessment items and demographic information using the smartphone~     application and questionnaire. Based on the information given by subjects, the medical team~     offers a management system that supports and improves the existing treatment process of~     diabetes using the application developed on its own. The feasibility and effectiveness of the~     management using the application are evaluated through the result values of the laboratory~     tests performed during the subject's usual medical care.~   "
7531|NCT03468270|"~     The aim of the study is to describe pain coping strategies and their evolution in children~     and adolescent with cerebral palsy.~   "
7532|NCT03468257|"~     The purpose of this study is to develop a healthy stress-induced eating intervention that~     will encourage individuals to replace unhealthy stress-induced eating with healthy~     stress-induced eating of fruit.~   "
7533|NCT03468244|"~     A single arm, open-label pilot study is designed to determine the safety, tolerability and~     effectiveness of personalized mRNA tumor vaccine encoding neoantigen in Patients with~     advanced esophageal squamous carcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma and~     colorectal adenocarcinoma~   "
7534|NCT03468231|"~     The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion~     chemotherapy (HAIC) of oxaliplatin plus fluorouracil/leucovorin compared with HAIC of~     oxaliplatin alone in patients with hepatocellular carcinoma (HCC) with major portal venous~     tumor thrombus (PVTT).~   "
7535|NCT03468218|"~     This phase II trial studies how well pembrolizumab and cabozantinib in treating patients with~     head and neck squamous cell cancer that has come back or spread to other places in the body~     and cannot be removed by surgery. Monoclonal antibodies, such as pembrolizumab, may interfere~     with the ability of tumor cells to grow and spread. Cabozantinib may stop the growth of tumor~     cells by blocking some of the pathways needed for cell growth. Giving pembrolizumab and~     cabozantinib may improve the chances of tumor response in patients with head and neck~     squamous cell cancer.~   "
7536|NCT03468205|"~     Background: Breathlessness is common through a range of chronic and life limiting diseases,~     such as chronic pulmonary disease and congestive hearth failure. There is a lack of knowledge~     concerning the understanding of the experience of breathlessness such as the relation between~     predicted, experienced and recalled breathlessness.~      Method: Questions on breathlessness intensity will be asked to participants with~     breathlessness several times daily through a mobile application installed on the users own~     cellphone. The mean experienced breathlessness will be related to the predicted and the~     recalled breathlessness as well as to background factors.~   "
7537|NCT03468192|"~     394 participants were cluster-randomized during 2010-2014. Depending on which ward the~     participants admitted to, they were allotted to free rehabilitation (non-precaution group,~     NPG, n=226) or our conventional regime with precautions and mandatory assistive equipment~     (precaution group, PG, n=168). The participants were followed during hospital stay, at 6~     weeks (postal questionnaire), 3 month (visit) and 6 months (reading of medical records) by~     means of function tests, health-related quality of life (EQ-5D) and other patient-reported~     outcome measures (PROM).~   "
7976|NCT03462446|"~     The main objective of this project is to evaluate savings in direct costs as regards the use~     of rivaroxaban versus vitamin K antagonists (VKAs) in routine clinical practice using data~     from three cohorts of patients receiving VKAs or rivaroxaban in Spain, including the time in~     therapeutic range (TTR) values of the same and the incidence of events in the first year~     following diagnosis.~   "
7538|NCT03468179|"~     N-acyl-phosphatidylethanolamine (NAPEs) and their active metabolites, N-acyl-ethanolamides~     (NAEs) are lipid satiety factors that are normally biosynthesized in the intestinal tract in~     response to food intake. Reduced levels of NAPEs and NAEs have been found in obese~     individuals, and increasing plasma NAPE and NAEs levels may be beneficial to obese~     individuals trying to lose weight or to keep off weight gain after losing weight. We have~     found that oatmeal has large amounts of NAPEs, and based on previous mouse studies, we~     hypothesize that a single dose of dietary oatmeal is sufficient to double plasma NAE from~     baseline, possibly inducing satiety and increasing basal metabolic rate. To test this~     hypothesis, we will feed volunteers a single weight-based serving of oatmeal while monitoring~     its effects on serum glucose, NAPE and NAE levels as well as on subjective satiety.~   "
7539|NCT03468166|"~     In chronic stroke patients, the data for motor function and gait pattern analysis was~     obtained.~   "
7540|NCT03468153|"~     Patients with relapsed or refractory lymphoma often develop resistance to chemotherapy.~     Chimeric antigen receptor-modified T cell (CART) therapy showed promising effect in B-cell~     malignancies these years. CD19 and CD22 are proteins expressed on the surface of the lymphoma~     cells in patients with CD19+CD22+ lymphoma. The CAR enables the T-cells to recognize and kill~     the tumor cell through recognition of CD19 and CD22. This is a phase 2 trial to study the~     safety and efficacy of dual specificity CD19 and CD22 CAR-T cell immunotherapy for CD19+CD22+~     relapsed and refractory lymphoma.~   "
7541|NCT03468140|"~     The number of liver transplants that can be performed is limited by the availability of~     organs. Livers that are steatotic (i.e., infiltrated by triglycerides and other fatty~     substances) are usually not used for transplants, due to increased risk of adverse events and~     deaths post-transplant. The investigators propose administering eculizumab to patients~     receiving macrosteatotic liver transplants and hypothesize that doing so will mitigate~     post-surgical adverse outcomes.~   "
7542|NCT03468127|"~     The FDA have revised the data on soy and concluded that a heart health claim is no longer~     justified based on more recent studies. They are allowing and established panel for public~     input. The selected studies have not been meta-analyzed, therefore we will conduct a~     meta-analysis of the 46 FDA selected studies to assess the effect of soy protein on surrogate~     markers of cardiovascular disease (LDL-C and TC).~   "
7543|NCT03468114|"~     This a cluster randomised controlled trial (cRCT) to evaluate the effect of a novel food~     hygiene intervention on infant health.~   "
7544|NCT03468101|"~     The main objective of the BALISTIC research program is to characterize COPD related to~     organic particles (of which the model is agricultural COPD) in comparison with~     tobacco-related COPD, at the clinical, functional (at rest and exercise), inflammatory and~     physiopathological level.~      The cross-sectional step BALISTIC 1 made it possible to include 400 patients between 2011 and~     2015, and to identify approximately 100 dairy farmers COPD and 100 non-dairy farmers COPD~     (tobacco COPD). Preliminary results, as well as those of an ancillary study that included a~     group of subjects exposed to mineral dust and fumes, suggest that agricultural COPD is a~     predominantly non-emphysematous or essentially bronchial disease with IgE-mediated allergic~     mechanisms.~      The current project BALISTIC 2 proposes to conduct a comparative study at + 6 years on~     average of the two groups of COPD subjects identified in BALISTIC 1 in order to specify the~     phenotype of COPD in dairy farmers by, in particular, the study of the rate of decline of~     resting and exercise respiratory function parameters, its computed tomography presentation~     and its genetic and epigenetic profile.~      The prospects of this work are to improve the management of COPD in any cause by setting up~     preventive and curative therapeutic approaches in order to provide answers to the progression~     of a disease that makes part of the few major public health problems of the 21st century.~   "
7545|NCT03468088|"~     This study aims to investigate the relative effect of handgrip strengthening exercise in~     improving function, pain, strength, and active range of motion (AROM) of the shoulder among~     patients with primary sub-acromial impingement syndrome (SAIS).~   "
7546|NCT03468075|"~     This study will enroll patients who have a diagnosis of locally advanced, unresectable or~     metastatic soft tissue or bone sarcoma (except gastrointestinal stromal tumors and Kaposi's~     sarcoma) from any site.~   "
7547|NCT03468062|"~     Dexmedetomidine is a selective a2-agonist and a sedative with anti-inflammatory,analgesic,~     and antiemetic effects, and its use for procedural sedation during endoscopy or ablation for~     atrial fibrillation has been increasing. It is also used for sedation in the intensive care~     unit. Recently, it was reported that dexmedetomidine is often used as an adjuvant for general~     anesthesia. Sympatholysis of dexmedetomidine can attenuate the increased sympathetic tone~     after surgery and result in antistress effects. In addition, opioid-sparing and analgesic~     effects are promoted by the perioperative administration of dexmedetomidine. Although it has~     been reported that the perioperative administration of dexmedetomidine improves quality of~     recovery after spinal and ENT surgeries, the outcomes for patients who undergo laparoscopic~     cholecystectomy remain poorly investigated.~      The aims of this study were to evaluate the effects of preoperative dexmedetomidine~     administration on quality of recovery by using the QoR-40 questionnaire in patients who~     undergo laparoscopic cholecystectomy.~   "
7548|NCT03468049|"~     One of the disabling consequences of stroke is hemipleic shoulder pain. Hemiplegic shoulder~     pain could be most important hinderance to upper extremity function after stroke . Evidence~     for rehabilitation approaches for shuolder pain suggested diverse approaches with strong need~     for further studies. This study planned to investigate the effect of Allium Cepa in the~     management of shoulder pain post stroke using four arms of the studying with three~     intervention groups and control group All participants who met study inclusion criteria and~     gave their consent shall be assessed at baseline for impairment (Fugl Meyer Assessment),~     activity limitation (Brief Pain Inventory) and participation restrictions (Stroke Impact~     Scale)~   "
7549|NCT03468036|"~     Data analysis of routinely applied extubation procedures on the ICU: i.e. extubation with~     100% O2 vs. 35% O2 with/without suctioning.~   "
7550|NCT03468023|"~     This study prospectively compares the performance of an above-elbow cast (long arm cast) and~     a below-elbow cast (short arm cast) to maintain reduction in conservatively managed distal~     radius fractures.~   "
11700|NCT03413670|"~     In the project, investigators plan to test difference of social cognition between depressive~     patients and healthy individuals and the brain activation underlying the difference to~     further understand the neural mechanism of depressive disorder.~   "
7552|NCT03467997|"~     This study uses an experimental design to conduct a double-blind, randomized, crossover study~     where participants receive both diesel exhaust and a mental stress test in a controlled~     setting. My hypothesis is that the synergistic effect of stress and air pollution will result~     in higher levels of stress and inflammation (measured via biological markers) as well as~     poorer cardiovascular disease related outcomes compared to the independent effect of each~     exposure separately.~   "
7553|NCT03467984|"~     The purpose of this study is to evaluate the safety and immunogenicity of LBVE (Multivalent~     Pneumococcal Conjugate Vaccine) in healthy infants.~   "
7554|NCT03467971|"~     This study will assess the food effect on bioavailability of Metformin/Gliclazide fixed dose~     combination tablet in fed and fasted state.~   "
7555|NCT03467958|"~     This is a Phase 3, open-label, multicenter extension study to evaluate safety and efficacy of~     ozanimod in subjects with moderately to severely active Crohn's Disease.~   "
7556|NCT03467945|"~     This study will investigate the bioequivalence and drug-drug interaction of~     Metformin/Gliclazide fixed combination tablet compared to co-administration of individual~     tablets of Metformin and Gliclazide.~   "
7557|NCT03467932|"~     This study is designed to explore efficacy of ORMD-0801 when given in different regimens~     across a dose range for up to 12 weeks in subjects with type 2 diabetes mellitus (T2DM).~   "
7558|NCT03467919|"~     This is a non-surgical trial comparing the clinical and functional outcomes of patients with~     osteoarthritis treated with Intra-articular injection of autologous Adipose-Derived Stem~     Cells (ADSC) combined with platelet-rich plasma (PRP) versus conventional therapy of~     Intra-articular injection of corticosteroid.~   "
7559|NCT03467906|"~     The purpose of the study is to compare dietary habits after bariatric surgery in patients~     with poor weight loss versus good weight loss outcomes.~   "
7560|NCT03467893|"~     Proton pump inhibitor are frequently used and are short term well tolerated ; but few studies~     show there are adverse event in long term prescription like fracture or pulmonary infection~     to Clostridum difficile. The fact is that multi medication in old patient increase the~     iatrogenic risk and decrease the medication compliance. The Proton pump inhibitor (PPI)are~     overused in this patient category.Several studies suggest the existence of a rebound effect~     when people were treated more than 8 weeks ; this effect seems to appear around 14 days after~     with hyperacidity symptoms.~      But there are no studies about old patient. So in this context the aim of the study is to~     evaluate the prevalence of rebound effect occurence after the end of PPI 8 weeks treatment.~   "
7561|NCT03467880|"~     The purpose of this study is to establish the reference values of impulse oscillometry (IOS)~     in healthy Chinese, and compare the indices of IOS in patients with lung disease, such as~     chronic obstructive pulmonary disease (COPD), asthma, interstitial lung disease (ILD), and~     upper airway Obstruction (UAO).~   "
7562|NCT03467867|"~     This is an open-label, multicenter, Phase II study to investigate the efficacy and safety of~     venetoclax in combination with Rituximab/hyaluronidase human in participants with relapsed or~     refractory chronic lymphocytic leukemia (CLL).~   "
7563|NCT03467854|"~     This study is designed to provide preliminary data to determine if concentrations of~     piperacillin/tazobactam change in patients with severe respiratory failure receiving~     extracorporeal membrane oxygenation (ECMO). The investigators hypothesize that patients will~     have significant changes in concentration measurements, specifically an increased clearance~     rate and increased volume of distribution, during ECMO as compared to critically ill~     patients.~   "
7564|NCT03467841|"~     Aim of the work~        -  To identify the prevalence of CMV infection in patients with steroid-refractory~          ulcerative colitis.~        -  To assess the clinical and endoscopic conditions in these patients.~   "
7565|NCT03467828|"~     Bronchopulmonary dysplasia (BPD) is a chronic lung disease that affects a ratio of up to~     20-30% of infants prematurely born before 30rd week. Delay of starting to speak, cerebral~     palsy and cognitive disorders may be seen in infants suffering from this disease. Although~     all the evidence found on the specific mediators and pathways that regulate the mechanism by~     studies made to understand the pathophysiologic mechanism, there hasn't been any remarkable~     progress on preventing the development of BPD in new-born infants born below 1500gr body~     weight. BPD is still one of the most important morbidity and mortality reasons in premature~     infants. There is a need of further studies to understand the genetic background of BPD~     specific to different populations, to identify polymorphisms related with the disease and for~     developing genetic methods for early the diagnose of the disease.~      With this purpose, first of all polymorphisms related with BPD and those which are related~     with similar other lung diseases will be investigated. DNA samples derived from blood samples~     of 200 patients (100 BPD infant and 100 control) will be examined for polymorphisms in~     specific genes that are chosen in the light of the prior literature scanning. To the~     investigators' knowledge, this will be the first study of a broad scanning of polymorphisms~     related with BPD in Turkish population.~   "
7566|NCT03467815|"~     For patients admitted to the medical ward, it is usually difficult to predict if their~     clinical condition will deteriorate, however subtle changes in vital signs are usually~     present 8 to 24 hours before a life-threatening event such as respiratory failure leading to~     ICU admission, or unanticipated cardiac arrest. Such adverse trends in clinical observations~     can be missed, misinterpreted or not appreciated as urgent. New continuous and wearable 24/7~     clinical vital parameter monitoring systems offer a unique possibility to identify clinical~     deterioration before patients progress beyond the point-of-no-return, where adverse events~     are inevitable. The WARD-COPD project aims to determine the number and duration of~     cardiopulmonary micro events during the first 4 days after hospital admission with Acute~     Exacerbation of COPD. We will also test the server installation, develop a database of core~     data and assess the frequency of artefacts and failure to capture the continuous monitoring~     signal.~   "
7608|NCT03467269|"~     Today the treatment of ischemic stroke in acute phase is based on medicinal or endovascular~     revascularization. Cerebral MRI sequences help the diagnostic. This procedure uses~     deoxyhemoglobin as an endogenous tracer. This is also a scorer of cerebral ischemia and the~     increase lets visualized transcerebral veins in the suffering zone giving a brush aspect.~     Several studies show the interest of this sign and conclude that deoxyhemoglobin presence is~     a predictive factor of cerebral ischemia. The aim of the study is to evaluate this brush-sign~     and correlate it with the prognosis retrospectively.~   "
7567|NCT03467802|"~     The purpose of this prospective, double-blinded, randomized, split-mouth study is to compare~     the effectiveness of a porcine collagen matrix (CM) and coronally advanced flap (CAF) with or~     without the addition of enamel matrix derivative (EMD) in the treatment of Miller Class I,~     II, or predictable class III recession defects. One defect will receive CM + CAF + EMD~     (Experimental), while the other will receive CM + CAF (Control) alone. The treatment of 60~     similarly sized Miller class I, II, or predictable class III recession defects on~     single-rooted teeth in 30 subjects using CM + CAF + EMD or CM + CAF alone will be evaluated.~     The subjects will be in good health, non-smokers, periodontally healthy with good oral~     hygiene and have no contraindications to periodontal surgery. Paired, similar sized defects~     on single-rooted teeth will be in the same subject and measure within 2mm of each other. One~     defect will be randomly assigned as the test group using CM + CAF + EMD, and the other as the~     control group using only CM + CAF. Clinical measurements will be made using a UNC-15~     periodontal probe by calibrated, board certified periodontists and will include: probing~     depth (PD), clinical attachment level (CAL), vertical recession (RD), and width of~     keratinized tissue (KT). Percent root coverage (%RC) will be calculated. The measurements~     will be used to evaluate surgical outcome. Surgical outcome will also be assessed using stone~     models. All measurements will be taken at baseline (on the day of the surgery) and 3 and 6~     months post-surgery for comparison.~   "
7568|NCT03467789|"~     The purpose of this study is to study 50 patients with multiple Basal Cell Carcinoma (BCC)~     who will be receiving Photodynamic Therapy (PDT) as treatment for their tumors. This study~     wants to establish the optimal conditions for treating BCC tumors with PDT. Previous research~     suggests that taking Vitamin D prior to the start of PDT could help improve the effectiveness~     of the treatment in eliminating the BCC. Overall, this study will help establish oral Vitamin~     D3/PDT as a new combination therapy for skin cancer (BCC).~      Photodynamic Therapy (PDT) is an investigational (experimental) technique that works by~     combining a photosensitizing topical agent and an intense light source to kill tumor cells.~     PDT is currently approved for the treatment of BCC in Europe, Canada, and Australia. However,~     it is experimental in the United States because it is not approved by the Food and Drug~     Administration (FDA).~   "
7569|NCT03467776|"~     The purpose of the study is to establish the methodology of bronchial dilation test by~     salbutamol MDI with Spacer in wheezy infants with asthma and to evaluate the effects of atopy~     on the exacerbation of wheeze in wheezy infants.~   "
7570|NCT03467763|"~     Metformin is a safe and effective first-line drug for type 2 diabetes that is also widely~     recommended for weight loss and diabetes prevention. But, metformin is associated with~     gastrointestinal and other side effects which prevent its use in 10-20% of patients and~     appear to limit the usable dose in others. This study is an N-of-1 trial design that will~     recruit 20 previously metformin-intolerant patients for re-challenge with metformin in a~     double-blind scenario. In this setting, 'intolerant' means either unable to take metformin at~     all, or unable to increase the dose past 1,000 mg despite the treating physician's~     recommendation to do so. Patients will be assigned to take their baseline medication regimen~     plus 2 weeks of 250 mg per day of metformin extended release, followed by 500 mg metformin~     XR, 750 mg, and 1,000 mg metformin XR with each treatment period separated by a 2-week course~     of placebo. Initial treatment, placebo or metformin XR, will be decided randomly. At the end~     of each two-week treatment period, participants will complete questionnaires assessing~     overall satisfaction with the medication, gastrointestinal symptoms, and adherence. Six~     months after the conclusion of the intervention, patients will be asked if they are~     continuing metformin at a higher dose than upon entry to the trial. This trial has two aims.~     First, to test the hypothesis that medication satisfaction will be the same during periods of~     placebo treatment and during periods of treatment with the active drug. The second aim is to~     test the hypothesis that > 30% of metformin-intolerant patients in an N of 1 crossover trial~     are able to tolerate higher-dose metformin at 6-months.~   "
7571|NCT03467750|"~     This randomized prospective study aims to determine the effect of ketorolac on the total dose~     of morphine required to achieve postoperative analgesia in children with obstructive sleep~     apnea (OSA) undergoing adenotonsillectomy. Participants will be randomly assigned to a study~     group where they will receive ketorolac in addition to the standard of care treatment or will~     receive only the standard of care pain management. The researchers hypothesize that by~     administering ketorolac at the end of the procedure once hemostasis has been achieved, it~     will be possible to decrease the amount of morphine administered in the post-anesthesia care~     unit (PACU). This study aims to provide a more comprehensive understanding of the efficacy~     and safety of the current standard post-operative analgesic regimen employed at the study~     institution, in which opioid analgesia currently plays a prominent role.~   "
7572|NCT03467737|"~     Research has demonstrated that there is a relationship between malnourishment and~     insufficient production of pancreatic enzymes, such as α-amylase which digests starch into~     glucose. Starchy foods that can be easily digested into glucose are critical to the~     development child for energy and proper growth. This study investigated the use of a~     noninvasive breath test for the assessment of amylase sufficiency, digestibility of normal~     and modified sorghum porridges and gastric emptying rate of a sorghum porridge in Malian and~     U.S. children.~   "
7573|NCT03467724|"~     Split-body/face evaluator-blind study of the safety and performance of fractional RF for the~     treatment of surgical scars following breast augmentation, abdominoplasty or face lift. The~     study will enroll up to 50 female subjects requesting treatment of surgical scars following~     breast augmentation or abdominoplasty and up to 25 male and female subjects requesting~     treatment of surgical scars following face lift surgery. Subjects will receive a total of~     three treatments of their surgical scars at one-month intervals on one side of the body or~     face only. Subjects will be followed up at one, two, three and ten months after their last~     treatment. Outcomes will be compared to the non-treated side.~   "
7609|NCT03467256|"~     The purpose of this study is to evaluate the safety and efficiency of autologous CD19 CAR-T~     lymphocytes in a cohort of pediatric and young adult patients with relapsed /refractory~     B—lineage acute lymphoblastic leukemia~   "
7610|NCT03467243|"~     The Veterans Health Administration (VHA) is advocating that Veterans with serious mental~     illness (SMI) receive recovery-oriented, rehabilitation approaches that target real-world~     functioning. One such approach is Cognitive-Behavioral Social Skills Training (CBSST). Unlike~     traditional cognitive-behavioral therapy, CBSST is a more recovery-oriented psychosocial~     rehabilitation intervention that teaches Veterans with SMI to correct errors in thinking and~     build social skills. While effective, CBSST has only been tested when facilitated by masters-~     or doctoral-level therapists, which limits its use in VHA. However, the investigators' pilot~     data shows that Peer Specialists-individuals with SMI who are hired and trained to use their~     own recovery experience to assist others with SMI-can also provide CBSST (called CBSST-Peer).~     Stand-alone social skills training (SST) is also a recovery-oriented program that VHA is~     attempting to rollout nationwide for Veterans with SMI. A few Peer Specialists have been~     trained to co-lead SST with professionals. However, SST is not widely implemented because~     professionals are busy and Peer Specialist delivered SST has not been tested. This study will~     evaluate the effectiveness of Peer Specialist-delivered CBSST and SST, which would increase~     access Veterans with SMI have to effective treatment. The investigators' aims are: Aim 1~     (Effectiveness): To compare the impact of CBSST-Peer on outcomes in Veterans with SMI to~     Veterans receiving Peer Specialist-delivered SST and Peer Specialist-led manualized,~     goal-focused groups of equal duration. The investigators will also assess fidelity of SST and~     CBSST. Aim 2: (Helpfulness of CBSST/SST--Peer and implementation barriers and facilitators):~     To use focus groups with patients and interviews with Peer Specialists and other staff to~     assess perceptions of SST- and CBSS Peer and identify potential barriers and facilitators to~     future implementation. Methods: This is a randomized, Hybrid 1 trial involving 252 Veterans~     with SMI (n=126 each from Pittsburgh, San Diego) comparing 3 treatment arms: CBSST-Peer vs.~     SST-Peer vs. a manualized, goal-focused group of equal duration. Hybrid 1 trials test the~     effectiveness of an intervention and collect implementation data that could inform its future~     adoption. At each site, across 6 waves (a wave = 1 CBSST-Peer, 1 SST-Peer, 1 goal focused~     group), 2 Peer Specialists will co-lead 18 groups, each lasting 20 weeks. Peer Specialists~     will be trained and receive an hour of supervision weekly by the CBSST developers. Master~     trainers from the SST rollout will train and supervise Peer Specialists in each site. All~     three arms' sessions will be taped and 25% rated for fidelity on standardized measures. A~     survey battery that assesses functioning, quality of life, recovery, and symptoms will be~     administered to the Veterans in each wave at: baseline, mid-intervention (10 weeks),~     end-of-intervention (20 weeks), and follow-up (32 weeks, 3 months post intervention). The~     investigators will examine all outcomes using Hierarchical Linear Models (HLM), with~     treatment condition included as a time-invariant covariate, and random intercepts for person~     and random slopes for time. Relevant covariates will include site, treatment attendance,~     symptom severity, service use, and demographic variables. The investigators will evaluate the~     effect for treatment conditions (CBSST-Peer vs. SST-Peer vs. goal focused group) in the~     expected direction and the time X group effect. Qualitative data on SST- and CBSST-Peer~     helpfulness and implementation factors will be collected from 8 focus groups, audio-recorded~     from a random sample of Veterans who participated in SST- and CBSST-Peer. Interviews will be~     conducted with participating Peer Specialists (n=approximately 8 per site), and key mental~     health staff (n=3-4 per site). The qualitative interviews and focus groups will be analyzed~     using rapid assessment, a team-based, iterative data collection and analysis approach~     providing data on the barriers and facilitators to future implementation of SST- and~     CBSST-Peer. Innovation: No study has tested peer-delivered SST or CBSST, or compared the two,~     in a rigorous trial. Significance/Expected Results: CBSST and SST are not widely available.~     If SST- or CBSST-Peer is effective, it could greatly increase the delivery of evidence-based~     services Veterans receive and enhance the services by VHA Peer Specialists.~   "
8181|NCT03459755|"~     The purpose of this study is to show that reduction in advanced glycation end-products (AGEs)~     is associated with the beneficial regulation of receptor for AGE (RAGE) mediated tumor~     response which may correlate with improved quality of life in PCa survivors. AGEs are~     produced by the body and are affected by lifestyle, weight and diet.~   "
7574|NCT03467711|"~     Laparoscopy is increasingly used for major abdominal and pelvic surgery. As this approach is~     also recommended in elderly patients with serious comorbidities, optimal fluid therapy~     guidance during this procedure is important.~      Many studies have reported that less invasive dynamic indices such as pulse pressure~     variation (PPV) and stroke volume variation (SVV), which are derived from the arterial~     pressure waveform, are superior to static indices to predict fluid responsiveness. PPV and~     SVV are based on the heart-lung interaction and reflect cyclic changes in stroke volume~     induced by mechanical ventilation in the closed-chest condition. Therefore, their ability to~     predict fluid responsiveness can be affected by factors that influence the arterial tone or~     the compliance of the respiratory system.~      Laparoscopic surgery for the abdominal visceral organs requires pneumoperitoneum and the~     Trendelenburg position to optimize surgical conditions, and can reduce cardiac output and~     respiratory compliance. Accordingly, the usefulness of PPV and SVV in predicting fluid~     responsiveness during laparoscopic surgery under these conditions may be questioned. A recent~     study investigated the effect of pneumoperitoneum during laparoscopy. Using an uncalibrated~     pressure waveform device, PPV and SVV had a relatively poor capacity to predict fluid~     responsiveness during laparoscopy. Interestingly, Sheila and colleagues recently reported~     that the changes in pulse pressure variation or stroke volume variation (ΔPPV6-8 and ΔSVV6-8)~     obtained by transiently increasing tidal volume from 6 to 8 mL/kg predicted body weight~     (tidal volume challenge) are superior to PPV and SVV in predicting fluid responsiveness~     during low tidal volume ventilation. The primary objective of this study was to demonstrate~     that the changes in PPV and SVV (ΔPPV6-8 and ΔSVV6-8) and the after a tidal volume~     challenge predict fluid responsiveness during pneumoperitoneum and Trendelenburg position.~   "
7575|NCT03467698|"~     The overall objective of this study is to explore whether transcranial Direct Current~     Stimulation (tDCS) can accelerate associative learning and boost associative memory in~     healthy subjects.~   "
7576|NCT03467685|"~     Perception of cutaneous sensory stimulation shows a large range of variability across~     multiple populations. Understanding this variability is critical to medical practice as~     interpretation of discomfort and pain is critical to diagnosis and treatment. Further,~     procedural medicine involves inflicting pain on patients in the form of injection of local~     anesthetic. Our protocol aims to determine how patients differentially interpret the~     non-noxious stimulation of vibration and the differences in perceiving anesthestic injection~     after the vibratory stimulus. We will explore how this ranges across all patients treated in~     a dermatological surgery out-patient setting. The goal is to identify which variables, such~     as age, gender, medical history, influence how sensation is interpreted.~   "
7577|NCT03467672|"~     Several studies have described the interest of eosinopenia as a marker of infection in~     internal medicine or in intensive care units. Eosinopenia is an inexpensive and easily~     accessible biological marker of sepsis. Retrospective work in the adult emergency departments~     of Strasbourg University Hospitals has shown the good specificity of this biological sign for~     the diagnosis of infection. Our work aims to confirm the results by a more meaningful study.~      Main objective: Evaluation of the interest of eosinopenia in the diagnosis of bacterial~     infection in ED.~      Methodology: inclusion of all patients with criteria for bacterial infection in ED, inclusion~     of an equivalent number of uninfected control patients.~      Duration : 12 months Multicentric prospective study 6 centers : Strasbourg, Hôpital Nord~     Franche comté, Sélestat, Wissembourg, Colmar, Mulhouse~   "
7578|NCT03467659|"~     Whole grains have been associated with controlled glycemic response and increased satiety~     compared to refined grains. However, the properties of whole grains which are responsible for~     these purported improved health outcomes are still unclear. The current study investigated~     the extent of whole grains' low glycemic property when food properties are controlled, and~     how this relates to gastric emptying rate and glycemic response.~   "
7579|NCT03467646|"~     A prospective randomized clinical study of all morbidly obese patients undergoing SG, RYGB~     and OAGB, as primary bariatric procedures, was performed. Patients were randomly assigned~     into 3 groups: those patients undergoing SG, those ones undergoing RYGB and those ones~     undergoing OAGB. BMI, excess BMI loss (EBMIL) and remission of type 2 diabetes (T2DM),~     hypertension (HT) and dyslipidemia (DL) were assessed.~   "
7580|NCT03467633|"~     This is a study looking at the feasibility of conducting a larger definitive research trial~     looking at the effectiveness of high intensity interval training in individuals who are~     scheduled for electro-cardioversion. Usual care for these participants is to go home and~     continue with their typical daily routine. The investigators will test whether participating~     in 3-weeks of thrice-weekly high intensity interval training before electro-cardioversion can~     lengthen the time to recurrence of atrial fibrillation after electro-cardioversion in these~     individuals. Participants will be asked to come to the University of Ottawa Heart Institute~     for a baseline visit at which fitness (cycle ergometer), body composition (weight, height,~     waist circumference and percentage body fat), heart rate variability and habitual exercise~     levels will be measured. Participants will then be randomized to either the exercise group or~     the usual care group. Those randomized to the usual care group will go home for 3-weeks and~     continue with their typical daily routine. Those randomized to the exercise group will return~     to the Heart Institute three times per week for 3-weeks to participate in a high intensity~     interval training program prior to their electro-cardioversion. All participants will be~     asked to measure daily heart rate and rhythm using the AliveCor system which is compatible~     with their Smartphones, for up to 12-months following their electro-cardioversion. All~     participants will be asked to return at 3-weeks (and prior to their electro-cardioversion) to~     measure fitness (cycle ergometer), body composition (weight, height, waist circumference and~     percentage body fat), heart rate variability and habitual exercise levels. The entire study~     should last approximately 15-months. Participants will be involved for 52-weeks. The~     investigators are looking to recruit 40 participants total for the feasibility trial. The~     investigators hypothesize that recruitment rates, drop-out rates, and adherence to the~     intervention will support a larger definitive trial.~   "
7581|NCT03467620|"~     To date, few studies have assessed the efficacy and safety of Cannabinoids, compounds derived~     from the Cannabis plant, in patients with Crohn's disease. Our study seeks to pilot a~     randomized, placebo-controlled trial assessing the efficacy and safety of oral cannabinoids~     as an adjunct therapy in patients with Crohn's disease.~   "
7582|NCT03467607|"~     A study of two ventilatory strategies for low tidal volume ventilation compared to a control~     group to elucidate if low tidal volumes of 3ml/kg or 4ml/kg were feasible for one lung~     ventilation.~   "
7583|NCT03467594|"~     BE@Work (Brief Exercise at Work) is a pilot controlled before and after trial of a workplace~     physical activity programme.~   "
7584|NCT03467581|"~     The aim of this study is to evaluate the long-term (5-year follow-up) results of laparoscopic~     gastric sleeve (LGS) in terms of weight loss and obesity related comorbidities, as well as~     the risk factors associated with postoperative nutritional deficiencies.~   "
7585|NCT03467568|"~     Humans display a preference for salt although the reasons remain unclear. The aim was to~     examine the hypothesis that salt may enhance mood. The study compares the drinking of water~     with and without electrolytes (either dissolved in water or by capsule). Mood was rated over~     a period of 155 minutes~   "
7586|NCT03467555|"~     The main objective of this study is to quantify the distal movement of maxillary central~     incisors and molars achieved with miniplate anchorage.~   "
7587|NCT03467542|"~     This study is a prospective, multicenter, single-arm study. Patients with Dural Arteriovenous~     Fistulas (dAVF) have a few choice for safe treatment. In this study, all patients with~     qualifying dAVFs will be treated with PHIL® Liquid Embolic material.~   "
13329|NCT03392389|"~     This clinical study will assess the safety, reactogenicity and immunogenicity of mRNA-1653, a~     combined human metapneumovirus and human parainfluenza virus type 3 vaccine in healthy~     adults.~   "
7588|NCT03467529|"~     New tools are needed to 1) diagnose and 2) stage early esophageal squamous cell carcinoma~     (SCC) in order to improve outcomes of this frequent and lethal cancer.~      Optical coherence tomography (OCT) is an optical technique, which can image human tissue ex~     vivo and in vivo with a resolution around 30µm and with a depth of 1mm. Full-field optical~     coherence tomography (FFOCT) is a new modality, which allows to image an ex vivo specimen~     with a cellular resolution and to perform 3D reconstruction. This device has never been~     tested on esophageal specimens.~      Therefore, the aim of this non-interventional research is 1) to determine FFOCT diagnostic~     criteria for SCC and 2) to figure if FFOCT allows the staging of the depth of invasion in~     SCC.~      To achieve these goals, we will image ex vivo 10 specimens of endoscopic resection of SCC~     (endoscopic mucosal resection (EMR) and submucosal dissection (ESD)) using an FFOCT device~     and we will compare the results with histological analysis of these specimens.~   "
7589|NCT03467516|"~     This is a Phase 2 study in which the efficacy of a non-myeloablative lymphodepleting~     preparative regimen followed by infusion of autologous TIL and high-dose aldesleukin in~     patients with metastatic uveal melanoma will be evaluated.~      Metastatic uveal melanoma (UM) carries a poor prognosis with estimated survival of 4-6~     months. There are no known effective systemic therapies. Metastatic UM is classified as an~     orphan disease and there are currently few clinical trial options for these patients. Thus,~     novel systemic approaches are desperately needed.~      A recent pilot study has found that administration of autologous tumor infiltrating~     lymphocytes (TIL) generated from resected metastases can induce objective tumor response and~     durable complete response in metastatic uveal melanoma patients. These encouraging results~     require confirmation to determine if this immunotherapy is of future benefit in treating this~     disease.~   "
7590|NCT03467503|"~     The purpose of this clinical study is to collect baseline information on dietary habits and~     metabolic risk factors, and to examine the effects of a dietary intervention focusing on~     fiber and antioxidant rich berries on the development of gestational diabetes, glucose and~     lipid control and inflammation in obese pregnant women at risk of developing diabetes. With~     the ongoing epidemic of obesity, the prevalence of gestational diabetes is significantly~     increasing and the goal of this research is to identify optimal dietary strategies that can~     reverse this condition or control the rise in blood glucose among those with already~     developed diabetes.~   "
7591|NCT03467490|"~     Dry Eye Disease (DED)is a chronic disease without a cure. Empowering patients to engage in~     better self-care requires knowledge of their disease and skills in self-management, which can~     lead to improved well-being and quality of life. The Investigation team has developed a DED~     self-management program (video series and educational booklet) that can be easily implemented~     into clinical use. The Investigators are going to use the Ocular Surface Disease Index (OSDI)~     to measure the dry eye in the participants. In addition, the research team plans to use the~     heiQ (validated questionnaire that assesses self-management and health education programs) to~     evaluate the DED self-management program by comparing results taken at baseline to 2 months~     after undergoing the self-management program.~   "
7592|NCT03467477|"~     This protocol is designed to serve as a pre-screening study for subjects who are potentially~     eligible for Alzheimer's Disease (AD) therapeutic trials that require tau imaging for~     inclusion by means of a flortaucipir F18 Positron Emission Tomography (PET) scan.~   "
7593|NCT03467464|"~     Rationale: Currently, for youngsters there is no treatment available that directly targets~     the core symptoms of autism. EMDR is hypothesized to improve the core symptoms of ASD by~     reducing the generally high stress levels experienced during social interactions, and~     increasing the functional connectivity in neuronal networks associated with executive~     functioning and limbic circuitry.~      Objective: The primary objective of the study is to determine if EMDR reduces the core~     symptoms of ASD and daily experienced stress in youngsters diagnosed with ASD.~      Study design: Longitudinal multiple single case studies. Study population: Youngsters aged~     12-21 years who are diagnosed with ASD and have a full-scale IQ of 80 or more (N=20).~      Intervention: 10 weekly EMDR sessions.~      Main study parameters/endpoints: The main endpoint of the study are autism symptoms, which~     will be assessed using the Social Responsiveness Scale (SRS-A) and the Autism Diagnostic~     Observation Schedule (ADOS 2). The SRS-A will be administered prior, during and after~     treatment. The ADOS 2 will be administered prior to treatment and after treatment completion.~     In addition, we will also administer the Trauma Symptom Investigation Form in Autism Spectrum~     Disorders (TIF-ASD) questionnaire prior to, during, and after treatment. Furthermore, to~     answer more fundamental questions concerning the working mechanism of EMDR in ASD, other~     secondary outcome measures (i.e. PSS-10, AWMA-2) will be included.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: Participants are expected to benefit from treatment. The risks associated with~     study participation are considered negligible and the burden associated with participation is~     estimated as low.~   "
7594|NCT03467451|"~     This safe and simple technique without extra cost would allow us to improve R0 resection~     ratio and so decrease relapses and the time between two different exams~   "
7595|NCT03467438|"~     Gastroesophageal reflux disease (GERD), according to the Montreal classification, is defined~     as a condition that develops when the reflux of stomach contents causes troublesome symptoms~     and/or complications. GERD, as clinically defined by the presence of heartburn, acid~     regurgitation, or both, at least once a week, is a global disease, being one of the most~     common gastroenterological disorders worldwide that affects roughly 10-30% of the general~     population in the Western world and less than 10% of the Asian populations. GERD~     complications may be life threatening and range from reflux esophagitis to Barrett's~     oesophagus and, eventually, adenocarcinoma.~      Zinc L-carnosine (brand name in Italy: Hepilor®) is a chelate compound of zinc and~     L-carnosine, with a long history of more than 20 years of clinical use in Japan that has~     recently become available in Italy for the treatment of any condition that requires a mucosal~     protection and mucosal repair within the gastrointestinal tract, thus including GERD.~     However, clinical data in western countries are limited. The aim of this double-blind,~     placebo-controlled study is to demonstrate the efficacy of Zinc-l-carnosine in maintaining~     GERD clinical remission during a 12-week treatment.~   "
7625|NCT03467035|"~     The objectives of this research grant are to determine the association of hypoxia with the~     severity of osteoporosis in the patients with bronchiectasis and whether the mechanism of~     inflammation is triggered by inflammasones, which makes it more prone to osteoporosis in~     patients with bronchiectasis.~   "
7596|NCT03467425|"~     The primary purpose of this study is to assess the effectiveness of TRELEGY ELLIPTA relative~     to non-ELLIPTA Multiple Inhaler Triple Therapies (MITT) for Chronic Obstructive Pulmonary~     Disease (COPD) control within the usual clinical practice setting. The study will be~     conducted once TRELEGY ELLIPTA has been approved in the countries in which the study will be~     conducted and is available commercially. This is a randomized, open-label, effectiveness,~     phase 4 study of 24 weeks' duration in COPD subjects to evaluate TRELEGY ELLIPTA (fluticasone~     furoate [FF]/vilanterol [VI]/umeclidinium bromide [UMEC]: 100 microgram [mcg]/62.5 mcg/25~     mcg) inhalation powder taken once daily using a single ELLIPTA inhaler compared with any~     non-ELLIPTA MITT in the usual care setting. Effectiveness of TRELEGY ELLIPTA will be assessed~     by comparing proportion of COPD Assessment Test (CAT) responders at Week 24 between two~     treatment groups. TRELEGY and ELLIPTA are trademarks of GlaxoSmithKline (GSK) group of~     companies. The study will enroll approximately 3000 subjects.~   "
7597|NCT03467412|"~     The trial is a multicentre, randomised, double-blind, placebo controlled phase 2 trial.~      60 healthy bald male subjects diagnosed with alopecia, who are between 18 and 55 years old~     and provide written informed consent will be eligible for inclusion.~      The trial period will consist of a screening period of up to 3 weeks followed by 12 weeks of~     dosing, three times per week. Each subject will receive two doses of the five trial treatment~     doses (placebo, 0.00625, 0.025, 0.050, and 0.100 μg respectively). The doses will be given as~     intradermal injections. On each volunteer, two treatment areas will be placed on the head and~     the two selected doses will be allocated to the respective treatment areas according to the~     randomisation scheme. The treatment areas will be selected on the border between the bald~     surface and the surface with hair.~      The effect on hair growth will be measured at week 8 and 12~   "
7598|NCT03467399|"~     The primary objective of this study is to assess the usability of a Cochlear implant system.~   "
7599|NCT03467386|"~     This pilot phase I trial studies the side effects of total bone marrow and lymphoid~     irradiation and how well it works with cyclophosphamide in treating patients with acute~     myeloid leukemia. Total marrow and lymphoid irradiation targets cancer in bone marrow and~     blood, instead of applying radiation to the whole body. Giving total bone marrow and lymphoid~     irradiation before a donor transplant helps stop the growth of cells in the bone marrow,~     including normal blood-forming cells (stem cells) and cancer cells. Drugs used in~     chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Giving total bone marrow and lymphoid irradiation before donor transplant and~     cyclophosphamide after transplant may work better at treating acute myeloid leukemia.~   "
7600|NCT03467373|"~     This is a phase 1B, multi-center, dose-finding study of RO7082859 administered in combination~     with obinutuzumab (Gazyva; [G]), rituximab (R) and standard doses of CHOP (G/R-CHOP or~     R-CHOP) in participants with Grades 1-3a r/r FL and untreated diffuse large B-cell lymphoma~     (DLBCL). Evaluating the safety, preliminary activity, pharmacokinetic (PK), and~     pharmacodynamic effects of this combination will be the main objectives of this study. The~     study is divided in two parts:~        -  Part I: Dose finding in participants with r/r FL~        -  Part II: Dose expansion in which the maximum tolerated dose (MTD) (or optimal biologic~          dose [OBD]) determined in Part I will be further assessed in participants with r/r FL~          and those with untreated DLBCL (>60 years old with an age-adjusted International~          Prognostic Index [IPI]) of 2-3), and the impact of using G in place of R in Cycle 1 on~          safety and tolerability will be assessed via a randomized, unblinded, two-arm design in~          participants with untreated DLBCL.~   "
7601|NCT03467360|"~     The investigators propose to study the carbonic anhydrase inhibition (acetazolamide)~     associated with concomitant radiochemotherapy in localized small cell lung cancer due to:~        1. The over-expression of carbonic anhydrases in this type of cancer,~        2. The Anti-tumor effect in preclinical acetazolamide in various tumor lines including~          neuroendocrine tumor lines,~        3. The observed synergy between irradiation and inhibition of carbonic anhydrases,~        4. Potential anti-tumor immune effect caused by decreased extracellular acidity.~   "
7602|NCT03467347|"~     This is a Phase I single-center, two-arm, open-label, randomized study in healthy~     HIV-negative women to evaluate the pharmacokinetics, safety, and bleeding patterns associated~     with 90-day use of matrix vaginal rings containing 200 mg Dapivirine and 320 mg~     Levonorgestrel.~   "
7603|NCT03467334|"~     This study evaluates the efficacy of Bifidobacterium breve CECT7263 and the mixture B. breve~     CECT7263/Lactobacillus fermentum CECT5716 in the treatment of infant colic. Group 1 will~     receive B. breve CECT7263 (2x10E8 CFU/day) one dose per day, group 2 will receive B. breve~     CECT7263 (1x10E8 CFU/day) and L. fermentum CECT5716 (1x10E8 CFU/day) in one dose per day,~     group 3 (control group) will receive simethicone 20 mg 4 times a day.~   "
7604|NCT03467321|"~     The aims of this study were to investigate balance and pulmonary functions in pregnant and~     non-pregnant women and to determine their relationship with LBP.~   "
7605|NCT03467308|"~     Colorectal cancer (CRC) is the third most commonly diagnosed cancer and the second leading~     cause of cancer-related death worldwide. In Egypt, CRC constitutes 4.2% of all cancers with~     median age is 50 years old.~   "
7606|NCT03467295|"~     This nationwide multicenter prospective cohort study will collect the treatment information~     and outcomes of the patients with previously untreated cavernous malformations (U-CMs) in~     China (at least 2000 patients from 20 centers). The investigators aim to determine the effect~     of different treatments on long-term outcomes in patients with untreated cerebral cavernous~     malformations.~   "
7607|NCT03467282|"~     Non-alcoholic Fatty Liver Disease (NAFLD) is characterized by excessive accumulation of~     lipids in hepatocytes, not associated with alcohol consumption and ranges from hepatic~     steatosis to steatohepatitis, a form that can progress to cirrhosis or hepatocarcinoma, and~     is considered a liver manifestation of the metabolic syndrome (MetS). The disease occurs in~     16 - 30% of the general population, but can reach up to 90% of obese individuals. Changes in~     lifestyle, including weight loss and physical activity are indicated with first choices for~     improvement of the liver condition.~      Recently the relationship between obesity, diabetes, MetS and NAFLD with intestinal~     microbiota has also been suggested in the development and progression of liver disease, since~     it is related to hepatic steatosis and inflammation. In this sense, this work aims to~     evaluate the effects of probiotic supplementation on intestinal microbiota modulation, degree~     of hepatic fibrosis and steatosis, inflammation and body composition.~   "
7611|NCT03467230|"~     A novel measure of nociception is the nociception level (NoL) index. The NoL index ranges~     from 0 to 100 and is based on a combination of nociception-related physiologic variables,~     which estimates the nociceptive/antinociceptive state.~      The purpose of this project is to conduct an observational study of the PMD-200 noninvasive~     monitor (Medasense Biometrics Ltd., Ramat Gan, Israel), As this is an observational study,~     this monitor will not be used for clinical decision making, and the point of the study is to~     assess what happens with the NoL index during routine care. After thorough discussion with~     patients and written informed consent is provided in the pre-operative unit, patients will be~     transferred to the operating room. Patients will be connected to a vital sign monitor and any~     other medical equipment needed for the surgical procedure, as required by the standard of~     practice. The PMD-200 finger probe will be connected to the left hand middle finger (or~     right). The PMD-200 will be activated after the induction of general anesthesia. A~     calibration period of 1-2 minutes will be performed. At the conclusion of the surgical~     procedure, the PMD200 will be disconnected from the patient.~      All the phases of anesthetic care are performed at the discretion of the anesthesiologist,~     but the time of administration of analgesics, muscle relaxants and other medications during~     anesthetic care will be recorded. The investigators will also record the time point of~     intubation (placement of breathing tube), extubation (removal of breathing tube), skin~     incision and any other significant surgical stimulation or noxious stimulation during the~     procedure. The investigators will be comparing NOL values prior to and following noxious~     stimuli, administration of analgesic agents and during non-noxious periods.~   "
7612|NCT03467217|"~     A multicenter, randomized, double masked, placebo-controlled, parallel treatment groups phase~     2 trial of losartan for pediatric nonalcoholic fatty liver disease (NAFLD).~   "
7613|NCT03467191|"~     This study aims to identify risk factors that prospectively predict alcohol problems in young~     adults.~   "
7614|NCT03467178|"~     Multicenter Phase II study on Decitabine-Carboplatin combination in platinum resistant~     ovarian cancer patients.~      Patients will receive study treatment until disease progression is documented, extraordinary~     medical circumstances occur, intolerable toxicities occur, or the patient withdraws consent.~   "
7615|NCT03467165|"~     This project aims at performing a pilot study to provide data on safety and potential~     efficacy of Magnetic Resonance guided Focused Ultrasound Surgery (MRgFUS) in the treatment of~     pain caused by trapeziometacarpal osteoarthritis (OA) and/or scaphotrapezial OA, and by hip~     OA, while exploring the potential application of MRgFUS to two different and central joints~     burdened by OA.~   "
7616|NCT03467152|"~     This study will be conducted to compare E2027 to placebo on the cognitive endpoint of~     Montreal Cognitive Assessment and the global clinical endpoint of Clinician's Interview Based~     Impression of Change Plus Caregiver Input in participants with dementia with Lewy bodies~     after 12 weeks of treatment.~   "
7617|NCT03467139|"~     The purpose of this study was to determine the effects of abdominal breathing exercises on~     pain, sleep quality and quality of life with adhesive capsulitis patients. The 41 adhesive~     capsulitis patients, 29 women and 12 men aged between 40-65 years, had divided into two~     groups by simple random sampling. In the study group, abdominal breathing exercise training~     was applied to routine physiotherapy program, in the control group routine physiotherapy~     program was applied for 8 weeks. Individuals were assessed for lung function test, range of~     motion, pain, sleep quality and quality of life. First assesment were performed at the~     beginning of treatment, 2nd assesment were performed at the end of 8 th week.~   "
7618|NCT03467126|"~     A prospective, single-arm, multi-center, non-randomized, pre-market study designed to provide~     clinical data regarding the use of the AcQMap High Resolution Imaging and Mapping System~     during an atrial fibrillation retreatment ablation procedure.~   "
7619|NCT03467113|"~     This is an open label study to evaluate the safety of ZX008 (fenfluramine) in patients with~     DS or LGS who are being administered CBD.~   "
7620|NCT03467100|"~     The XEN901 Phase 1 clinical trial is a randomized, double-blind, placebo-controlled study~     that will evaluate the safety, tolerability and pharmacokinetics (PK) of both single~     ascending doses (SAD) and multiple ascending doses (MAD) of XEN901 in healthy subjects. It is~     estimated there will be approximately 64 subjects in the planned SAD and MAD cohorts.~   "
7621|NCT03467087|"~     Intensive chemotherapy, with or without following autologous or allogeneic stem cell~     transplantation (HSCT), is often the only curative treatment option for patients with~     haematological malignancies, leave many survivors physically and psychologically impaired~     because of side effects, many caused by weeks of immobilisation. Electrical muscle~     stimulation (EMS) is a proven training tool to improve physical performance in seniors and~     patients with chronic disease. The investigators therefore intend to evaluate the safety and~     feasibility of EMS in patients undergoing autologous HSCT, allogeneic HSCT and intensive~     chemotherapy. To assess feasibility all patients are asked to document training time during~     hospitalization in an EMS diary.~      Furthermore, physical Performance will be measured using the 6-minute-walking distance (6MWD)~     and Short Physical Performance Battery (SPPB) as well as psychological performance using the~     Multidimensional Fatigue Inventory (MFI) and EORTC QLQ-C30 at the start of chemotherapy (T1)~     and when patients are discharged from hospital (T2).~      At the time intensive chemotherapy is started and all inclusion and no exclusion criteria are~     met, patients will receive an EMS device with electrodes and will be instructed on how to use~     the device. After that, baseline tests using the above mentioned tools will be performed.~      EMS will be conducted with a Myopuls 2000 (Curatec Services GmbH, Moers, Germany) device~     using 13 cm x 5 cm electrodes. Electrodes are placed subsequently on both thighs and upper~     arms with instructions to stimulate each limb for at least 15 minutes on at least 5 days per~     week. Stimulation settings were as follows: 300 µs pulse width, 60 Hz frequency, 5 seconds~     on, 5 seconds off. The amplitude is initially set to elicit a visible muscle contraction and~     patients are encouraged to increase the amplitude as much as tolerated. After an initial~     training session, patients are to use the devices on their own and document their activities~     in an EMS diary.~      Patients are then asked to use EMS throughout their therapy in addition to physical therapy~     until the day of their discharge when the initially performed tests are repeated.~      The investigators hypothesis is, that EMS can be safely applied in patients undergoing~     intensive chemotherapy regimens and that patients are able to administer EMS by themselfs.~   "
7622|NCT03467074|"~     The following observational study will investigate whether the vaccine response (antibodies,~     T and B cells) after allogeneic stem cell transplantation is influenced by genetic~     polymorphisms in the interferon lambda signal.~   "
7623|NCT03467061|"~     This study evaluates whether dietary manipulation of the oral microbiota modulates~     cardiovascular health through effects on nitric oxide bioavailability.~   "
7624|NCT03467048|"~     Our goal is to compare conventional direct laryngoscopy using a Macintosh blade with the~     McGrath videolaryngoscope for endotracheal intubation in very morbidly obese patients~     undergoing non-cardiac surgery. Specifically, we propose to test the primary hypotheses that~     videolaryngoscopy improves visualization of the vocal cords, defined with modified Cormack~     and Lehane classification, compared to direct laryngoscopy.~   "
7626|NCT03467022|"~     Scurvy, or latent scurvy, may be underestimated in developed countries, but continue to be~     described, often as case report. Little is known about the prevalence of vitamin C deficiency~     in a specific population as withdrawal alcoholics and about his possible consequences, latent~     scurvy.~      In an observational study, the investigators will evaluate prospectively the prevalence of~     vitamin C deficiency in alcoholic withdrawal patients, its correlation with latent scurvy,~     mainly tiredness and weakness, and the evolution of the latter at three months after oral~     vitamin C supplementation.~   "
7627|NCT03467009|"~     The purpose of this randomized controlled study is to evaluate acceptability and feasibility,~     and to gather preliminary data about efficacy, of iPACT (intervention to Prevent Adolescent~     Cyber-victimization with Text messages), a brief in-clinic introductory session +~     longitudinal automated text-message-based secondary prevention program for adolescents with a~     history of past-year cyber-victimization presenting to a pediatric clinic for well-child~     visits.~   "
7628|NCT03466996|"~     The purpose of this study is to explore the feasibility and efficacy of using telemedicine to~     improve transition from pediatric to adult care in patients with spina bifida.~   "
7629|NCT03466983|"~     Treatment with iron isomaltoside and ferric carboxymaltose in subjects with iron deficiency~     anaemia due to inflammatory bowel disease and comparison of the incidence of hypophosphatemia~   "
7630|NCT03466970|"~     IgG4-related disease (IgG4-RD) is an immune-mediated, fibro-inflammatory disease that leads~     to tissue damage, organ dysfunction and, if untreated, to organ failure. The disease can~     affect almost any anatomic location, but the sites involved most commonly are the pancreas,~     salivary glands, orbital adnexa, lymph nodes, and retroperitoneum. IgG4-RD, typically~     diagnosed among individuals who are middle-aged, is characterized by a male predominance~     except with regard to organs of the head and neck (e.g., the salivary glands and orbits),~     where the gender distribution is approximately equal. The epidemiology of IgG4-RD remains~     poorly understood because of its recognition only recently as a multi-organ disease. However,~     IgG4-RD accounts for many conditions once regarded as disparate, single-organ disorders The~     purpose of our study is to evaluate the method of plasmablast measurement in peripheral blood~     of IgG4-RD patients, for diagnosis and follow-up on disease progression and response to~     treatment. This document will outline the collection, processing and testing procedures for~     measuring plasmablasts from IgG4-RD patients~   "
7631|NCT03466957|"~     MRI guided adaptive brachytherapy (BT) represents the gold standard in the treatment of~     gynecological cancers. Commercially available standard MRI compatible applicators for BT of~     gynecological cancers don't always allow for optimal target volume coverage.~     Three-dimensional (3D) printed technology enables versatile possibilities of improvement of~     standard applicators and development of novel applicators with better coverage of the target~     volume. The purpose of this study is to implement and assess 3D printing technology as an~     instrument for designing and manufacturing applicators for individualized BT of gynecological~     cancers.~   "
7632|NCT03466944|"~     This is a pilot cancer imaging study investigating change in the apparent diffusion~     coefficient (ADC) at a single time point post-transplantation in patients. The treatment is~     bone marrow transplant as per standard patient care, without change for trial purposes.~      Its main aim is to evaluate the engraftment of bone marrow after transplantation performing~     functional Magnetic Resonance Imaging (MRI) of the lumbar spine and pelvis at baseline and~     after 2-3 weeks after the transplantation (according to the appearances of raised white blood~     cells).This will enhance the understanding of bone marrow features on imaging at engraftment~     and improve the management of children/young adults who suffer acute leukaemia.~      Following allogenic haemopoietic stem cell transplantation, changes in bone marrow apparent~     diffusion coefficient (ADC) are measurable at the point of engraftment and in conjunction~     with peripheral blood counts may provide a future biomarker of successful clinical outcome.~   "
7633|NCT03466931|"~     Food allergies have become a relevant health problem in westernized societies, particularly,~     with children. Cow's milk (CM), along with hen's eggs, are the most common foods eliciting~     allergic reactions in children under 4 years of age. The main objective of this intervention~     study is to evaluate the safety and efficacy of the intervention known as The Milk Ladder~     in the development of tolerance by children with CM allergies. This will be compared to an~     historical cohort (CoALE), which investigated the natural history of this allergy.~     Additionally, the ability of informative epitopes will be evaluated for their potential to~     predict tolerance and their correlation against clinical variables.~      The Milk Ladder will be evaluated within a prospective cohort of CM allergic children. This~     intervention is enacted through the introduction of meals cooked with progressively~     increasing amounts of cow's milk into the participant's diet. The primary outcome will be the~     development of tolerance which will be evaluated through a double-blind placebo-controlled~     food challenge. IgE and IgG4 epitopes will be described using a peptide microarray~     immunoassay. Quality of life will be determined by administering the FAQLQ-PF~     disease-specific questionnaire. Finally, within a subgroup of study participants, the ability~     of different peptides to activate basophils will be analyzed, and CM T cell epitopes will be~     studied by means of T-cell proliferation and cytokine production assays.~   "
7634|NCT03466918|"~     To evaluate the safety and effectiveness of the SAPIEN 3 (Edwards Lifesciences, Irvine,~     California) transcatheter heart valve implantation (TAVI) in Chinese patients with~     symptomatic severe calcific aortic stenosis who are considered at high risk for surgical~     valve replacement.~   "
7635|NCT03466905|"~     There is a need to reduce the number of ambulance transports to the Emergency Room to the~     patients who are not in need of urgent medical care. There are currently no studies and the~     aim of the study is to investigate if the ambulance transports to the Emergency Room can be~     reduced by a dialogue between a Registered Nurse in ambulance and a Medical Doctor in the~     Primary Care (called Ambulant assessment). In this connection there is also a need to~     follow up patients that not have been transported to the Emergency Room, secondary ambulance~     transport, relapse within 48 hours, type of examination and treatment and mortality.~   "
7680|NCT03466320|"~     This open-label Phase I study aims at assessing primarily the safety of the NKR-2 treatment~     administered after a non-myeloablative preconditioning regimen in r/r AML/MDS patients.~      This Phase I study will contain two different sequential segments. The first segment will~     determine the recommended investigational treatment option (schedule of preconditioning and~     NKR-2 dose) and the second segment will expand to a larger number of r/r AML/MDS patients.~   "
7636|NCT03466892|"~     Theoretical models of chronic pain hypothesize a privileged treatment of pain-related~     information that would be the basis of avoidance behaviors in chronic pain. This privileged~     treatment, also called attentional bias, has been found experimentally in chronic pain.~     Meta-analyses confirmed that but leaded the question of the difference found between bias in~     period of attention orientation and bias in period of maintained attention. One of the~     hypotheses is to consider one or more cognitive processes that would fix the attention~     around significant perceived problems and that would hinder the attentional disengagement and~     the reorientation of attention towards neutral or positive stimuli. In view of the scientific~     literature in psychopathology but also in chronic pain we think that the negative repetitive~     thoughts (RNT) variable is one of these processes. So the investigators want to better~     understand the difference of attentional bias at different moments of the attentional process~     by interrogating the Repetitive Thinking variable. More specifically the investigators test~     the Attentional Bias hypothesis in Fibromyalgia. Patient with Fibromyalgia will be recruited~     at the Pain Center of CHU-Amiens. Patients will complete different scales and also the visual~     probe task. First, the investigators hypothesize the attention bias for pain-related~     information in the FM group is correlated with the level of negative repetitive thinking in~     the maintained attention phase. Second, the investigators hypothesize the attention bias is~     more important in the attention maintenance phase (1250 ms) than in the attention orientation~     phase (500 ms).~   "
7637|NCT03466879|"~     Demonstrate the ability of subjects suffering from sinus pain to self-treat with the SYNUS~     Pain Relief device and to obtain pain relief compared to a sham/placebo device.~   "
7638|NCT03466866|"~     This RCT will compare the efficacy of COPDE (COmmunity Care to Prevent Diabetes Emergencies)~     vs. intensive home-based diabetes (DM) education [i.e., Enhanced Usual Care (EUC)] to reduce~     DM-related emergency department (ED) visits and/or hospitalizations over 12 months (primary~     outcome) in 230 blacks with diabetes, 50 years and older, after an ED visit. A moderation~     analysis will determine whether participants who reside in low- vs. high-need communities~     [defined by Community Need Index scores (i.e., an indicator of the built environment)]~     respond differently to treatment.~      COPDE is a collaborative intervention of Primary Care Physicians, (PCPs), a DM nurse~     educator, and Community Health Workers (CHWs) that extends from the ED into the community.~     The CHWs will: 1) deliver in-home DM education to increase participants' knowledge and skills~     to manage DM; 2) use DM-specific Behavioral Activation to reinforce DM self-care; and 3)~     facilitate telehealth visits with PCPs and a DM nurse educator to increase access to care.~     The control treatment, EUC, is home-based intensive DM education. EUC matches COPDE in~     treatment intensity (i.e., number and duration of in-home visits) and delivery of DM~     self-care education, but does not include COPDE's other active elements (i.e., Behavioral~     Activation and telehealth). The treatment comparison will identify COPDE's specific efficacy~     over and above EUC. We hypothesize that COPDE will halve the rate of incident DM-related ED~     visits and/or hospitalizations relative to EUC. The three secondary outcomes are: 1)~     subjective perceptions of access to care; 2) receipt of DM Quality Metrics (i.e., objective~     indicators of realized access to care); and 3) DM self-care.~   "
7639|NCT03466853|"~     Assessment of malnutrition within 48 hours of birth through anthropometric indices as Weight,~     Length and Head circumference, Proportionality indices as MAC/HC ratio, Ponderal index and~     Body mass index, Clinical assessment of nutritional status (CANS) score. Detection of early~     neonatal morbidities within the first week of life including Hypoglycemia ,Polycythemia,~     Respiratory Distress Syndrome, Neonatal sepsis, Hyperbilirubinemia and Feeding intolerance~   "
7640|NCT03466840|"~     Comparison of cronally advanced lingual flap to modified periosteal releasing incision (MPRI)~   "
7641|NCT03466827|"~     The aim of the study is to determine the efficacy of selinexor in adults with TETs determined~     by overall response rate (RECIST 1.1) in two parallel cohorts of patients with advanced~     thymomas or thymic carcinomas. The study is an international, multicenter, open label phase~     II trial using Simons two stage design. The study population is adults with histologically~     confirmed, advanced, inoperable TETs who are progressing after treatment with least one~     platinum containing chemotherapy regimen.~      This study is comprised of 2 similar phase II tirals, one running in EU (25 patients) and one~     running in US (25 patients).~      There are two study arms:~      Arm A: Thymoma~        -  Stage 1: 15 patients~        -  Stage 2: 10 patients~      Arm B: Thymic carcinoma~        -  Stage 1: 15 patients~        -  Stage 2: 10 patients~   "
7642|NCT03466814|"~     Observational study of abatacept in the treatment of JIA in Japan.~   "
7643|NCT03466801|"~     Multi-center, prospective, randomized, controlled study to verify the efficacy of prednisone~     alone and combination therapy with methylprednisolone and cyclophosphamide in the treatment~     of stage I membranous nephropathy.~   "
7644|NCT03466788|"~     Through this study, The investigator believe to evaluate the impact in terms of overall~     quality of life of adjuvant chemotherapy in patients with locally advanced endometrial cancer~     at a distance from their care~   "
7645|NCT03466775|"~     Incompatibility between non-genetically identical donors and recipients has been increasingly~     recognized as the main contributing factor to solid allograft rejection and failure, through~     the triggering of donor-specific responses mediated by T- and B-lymphocytes. The Human~     Leucocyte Antigen (HLA) system has been identified as the main target of donor-specific~     responses, especially through the production by the recipient of antibodies directed toward~     non-self donor HLA molecules expressed on the allograft endothelium. As a consequence, in~     organ transplantation, the current approach to immunological risk stratification, patient~     monitoring and rejection diagnosis is based on biomarkers derived from the HLA system.~     However, this approach does not provide a sufficient accuracy for the risk stratification and~     the diagnosis of immunological complications in solid organ transplantation, which still~     remain the dominant cause of allograft failure.~      A recent body of evidence supports that specific non-HLA antigens expressed on the allograft~     endothelium may be relevant to allograft rejection, suggesting that a new strategy to~     transplant diagnostic testing at a non-HLA level would help to overcome the limitations of~     the current HLA-based approach to immunological assessment of transplant recipients. Among~     antibodies to non-HLA endothelial antigens, angiotensin II type 1 receptor activating~     antibodies have been the most widely reported antibodies to associate with the occurrence of~     allograft rejection, dysfunction and loss, even if their independent role, with respect to~     the presence of concomitant anti-HLA antibodies, has not been demonstrated.~   "
7646|NCT03466762|"~     The main aim of this study is to evaluate the impact of head & neck cancer and brain tumors~     on lives of patients in Pakistan. To the best of the investigators knowledge this will be the~     first in-depth study to evaluate resilience and quality of life (QoL) among this group of~     patients. These patients encounter challenges as they battle to maintain optimistic outlook~     towards life. Resilience and QoL among them changes over time and may be modifiable towards~     increased well-being. Resilience and QoL are critical components during diagnosis, treatment,~     survivorship, and at the end of life. Hence, these are important traits for promoting~     positive psychological well-being. Through this study the investigators will be able to~     identify problems faced by such patients in our setting. the investigators will be able to~     plan appropriate interventions to improve a person's resiliency and quality of life, reduce~     depression and anxiety, and increase their satisfaction with life. This study is also aimed~     to inform healthcare providers and researchers regarding protective or risk characteristics~     for coping with cancer. Practices and resilience interventions may improve well-being and~     adherence to care guidelines.~      The objectives of our study are:~      Primary Objectives:~        -  To determine resilience and quality of life scores after treatment separately for head &~          neck cancer and Brain tumor patients in Pakistan.~        -  To evaluate important factors associated with resilience and quality of life after~          treatment separately for head & neck cancer and Brain tumor patients in Pakistan.~      Secondary Objective:~      • To examine the relationship between resilience and quality of life after treatment~     separately for head & neck cancer and Brain tumor patients in Pakistan.~      It will be an analytical cross sectional study design. The study will be conducted at the Aga~     Khan University Hospital, Karachi. Study participants will be men and women greater than 18~     years, with brain tumors or head & neck cancer fulfilling the eligibility criteria.~     Approximately 250 patients will be recruiting with brain tumors and 250 with head & neck~     cancer. Validated tools will be used to measure resilience and QoL.~   "
7647|NCT03466749|"~     The aim of this Real-world study in China is evaluating the Safety and Efficacy of Paclitaxel~     Eluting Balloon Catheter in Coronary de-novo lesions(target vessel~     diameter:2.5mm-4.0mm)Treatment. And the primary point of this study is the target lesion~     failure of 12 months after surgery.~   "
7648|NCT03466736|"~     The primary objective of this study is to demonstrate that individuals with low short-term~     practice effects (STPE) on cognitive testing are more likely to be identified as positive~     on amyloid imaging than individuals with high STPE. STPE may also inform us about other~     AD-related biomarkers, including hippocampal volumes, functional connectivity, and APOE~     status. By realizing the aims of this pragmatic study, we hope to be able to offer more~     economical and efficient screening of potential participants for clinical trials, which would~     reduce participant burden and financial costs.~   "
7649|NCT03466723|"~     microRNAs (miRNAs) regulate fundamental cell processes. Dysregulation of miRNA expression and~     function is reported in various diseases including cancer, metabolic disorders as well as~     neurological disorders. Circulating miRNAs have been proposed to mirror physiological and~     pathological conditions suggesting their use as biomarkers for various diseases. The study~     will focus on a case-control study cohort (N=1000) of subjects recruited at the IRCCS~     Neuromed for which a deep clinical characterization and genome-wide sequencing data are~     available. This study will enable to identify novel circulating biomarkers for Parkinson's~     disease (PD). Further, the project will give new insights on the involvement of miRNAs in the~     etiology of PD and in the understanding of the genetics of the disease thus opening avenues~     for novel therapeutic strategies.~   "
7650|NCT03466710|"~     There is weak evidence supporting optimal follow-up of women with ASC-US or LSIL cytology~     found to have low grade disease or normal findings at initial colposcopy. Surveillance~     options include continued colposcopy, discharge with Pap testing, or HPV testing at 12~     months. The investigators performed a pilot randomized controlled trial (RCT) comparing these~     3 follow-up policies. Study objectives are to determine the feasibility of an RCT and to~     compare the incidence of >/=HSIL in each of the arms by intention to treat principle.~   "
7651|NCT03466697|"~     Healthy subjects will be enrolled in this study. Each subject will be scanned twice with~     F18-FP-CIT PET which is commercially available. F18-FP-CIT reflects dopamine transporter~     availability of striatum. Before each PET scan, subject will be injected either glucose or~     normal saline. Therefore, PET scan will reflect the changes of dopamine transporter~     availability after the injection of glucose.~   "
7652|NCT03466684|"~     High volume fluid therapy in open abdomen (OA) trauma patients contributes to excessive~     visceral edema, delayed fascial closure, and prolonged parenteral nutrition. Thus, we~     investigated whether bioelectrical impedance analysis-directed resuscitation reduced~     postoperative fluid overload, and improved outcomes in OA trauma patients.~   "
7653|NCT03466671|"~     To test efficacy and safety of a novel nasal spray of oxytocin on social deifies in autism~     spectrum disorder, and To compare effect sizes of different doses~   "
7654|NCT03466658|"~     The objective of the study is to evaluate the efficacy of preoperative treatment with a~     novel, wireless, low-level microcurrent-generating antimicrobial device (brand name:~     JumpStart) in preventing the spread of Propionibacterium acnes in patients receiving open or~     arthroscopic shoulder surgery.~   "
7655|NCT03466645|"~     Surgical-site infection is the most commonly reported nosocomial infection in patients~     undergoing surgery and 3rd most nosocomial infection in hospitalized patients. The SSI is~     associated with increases of length of hospitalization for 6 days and increases the~     hospital's cost by $ 300.~      Because of these, prevention of SSI with appropriate antibiotic is essential.~   "
7656|NCT03466632|"~     Dexmedetomidine as a Sedative Agent for Patients Presented for Lower Gastrointestinal~     Endoscopy~   "
7657|NCT03466619|"~     Erectile dysfunction (ED) is defined as the persistent inability to attain and or maintain an~     erection sufficient to permit satisfactory sexual performance~   "
7658|NCT03466606|"~     Pre-habilitation programs that combine physical training, nutritional support and emotional~     reinforcement have demonstrated efficacy as presurgical optimization strategies in the~     context of digestive surgery. The experience in patients at risk for cardiac surgery, one of~     those associated with higher morbidity and mortality, is anecdotal. Main objective: to~     evaluate the feasibility, efficacy and cost-effectiveness of a pre-habilitation program for~     the improvement of preoperative functional capacity in high-risk and intermediate risk groups~     for cardiac surgery and its impact on the reduction of postoperative complications (primary~     endpoint). Secondary objectives: (i) in-hospital stay; (ii) symptoms, quality of life, (iii)~     evaluation of information and communication technologies (ICT) as a support for the~     pre-habilitation, and (iv) design and validation of indicators for a future large-scale~     implementation of this type of intervention.~      Design: Subproject: #1: Prospective study of the efficacy of prehabilitation in heart~     transplant candidates during the study period. The results will be compared with historical~     records; #2: Randomized controlled trial with a 1:1 ratio to assess the efficacy of~     prehabilitation in patients undergoing elective coronary revascularization or valve~     replacement surgery. Subjects: Subproject #1: 40 patients candidates for heart~     transplantation. Subproject #2: 80 patients in the prehabilitation group and 80 controls in~     which a conventional treatment will be performed. Intervention: (i) personalized supervised~     resistance training, and (ii) program to promote physical activity and healthy lifestyles.~     The overall duration of the intervention is estimated to be at least 4-6 weeks (variable in~     each subproject). The support with ICTs will be a significant aspect of the program in which~     the adaptation of the personal health folder of Catalonia (Cat@SalutLaMevaSalut) will be~     fundamental.~   "
7681|NCT03466307|"~     This study aimed to investigate the effects of nocturnal pain on clinical and~     ultrasonographic parameters in patients with rotator cuff tendinopathy.~   "
7659|NCT03466593|"~     Open upper gastrointestinal surgery includes surgery in the upper abdomen such as~     ventricular, duodenal, pancreatic and biliary tract surgery. After upper abdominal surgery~     there is a risk of gastrointestinal and cardiopulmonary complications. There is currently~     insufficient knowledge about the effect of prehabilitation and extra early postoperative~     mobilization in upper pancreatic surgery.~      This study's aim is to evaluate the effect of prehabilitation and extra early mobilization.~      The study includes two substudies:~        1. A prospective cohort of 75 patients undergoing pancreatic surgery after a~          prehabilitation program will be compared to 75 historical controls. Primary outcome is~          postoperative complications.~        2. A randomized controlled trial based on 72 patients undergoing pancreatic studying the~          effect of extra early rehabilitation. The intervention group will be mobilized to~          bedside, standing or sitting in armchair <6 hours after surgery, ie 3-4 hours after~          arrival at the Postoperative Department (PIVA). The control group will be mobilized~          according to routine i.e. the morning after surgery. Primary outcome is PaO2.~   "
7660|NCT03466580|"~     The aim of the project is to evaluate the use of the caregiver-led 'CSNAT intervention' to~     identify, prioritize and address support needs among caregivers of patients who are starting~     in specialized palliative care at home in Denmark~   "
7661|NCT03466567|"~     The aim of the study is to investigate the effect of the medicines, probenecid and~     ciclosporin on the concentrations of SNAC. SNAC is an ingredient of the semaglutide tablets.~     Participants will get 3 different treatments (that is 3 treatment periods): 1) a single dose~     of 3 mg semaglutide, 2) a single dose of 600 mg ciclosporin with 3 mg semaglutide, 3) 500 mg~     probenecid twice a day for 3 ½ days with a single dose of 3 mg semaglutide on the last day.~      The sequence of treatments participants get is decided by chance. Probenecid and ciclosporin~     are available medicines. They are given by doctors. Semaglutide contains SNAC. It cannot be~     prescribed yet.~      The study will last for up to 125 days. Participants will have 17 to 18 visits at the study~     centre. This includes short visits at the centre for blood sampling only. Participants will~     have several blood draws.~   "
7662|NCT03466554|"~     Posttraumatic stress disorder (PTSD) is the long term effect of severely distressing~     traumatic event characterized by intrusive thoughts, nightmares, and avoidance. Brain imaging~     of PTSD patients demonstrate alterations in regional brain perfusion, with stunned,~     hypoperfused regions. Those brain-biological pathologies may be responsible for the limited~     success rate of currently available interventions.~      During the last years data regarding Hyperbaric Oxygen Therapy (HBOT) induced neuroplasticity~     accumulated. A number of studies in traumatic brain injury, cerebrovascular attacks, and~     fibromyalgia have presented evidence of improved perfusion and recovery of metabolic brain~     tissues, accompanied by clinical improvement under HBOT even years after the acute insults.~      Considerable evidence supports potential benefit of HBOT on PTSD, however, no clinical trial~     was done on this pure PTSD population. The aim of the proposed study is to examine hyperbaric~     oxygen therapy as a treatment for PTSD. Advanced brain imaging and functional analysis tools~     will be used to evaluate treatment's effect.~   "
7663|NCT03466541|"~     The aim of this study is to investigate the effectiveness of two workplace interventions (the~     Riskbruk model and Balance) in reducing risky alcohol consumption, sickness absence and~     presenteeism. The purpose is to assess whether the Riskbruk model should be implemented in~     the Norwegian workforce in its entirety, whether the less extensive and costly alternative~     Balance is sufficient, or if neither one of them show effectiveness compared to usual care.~   "
7664|NCT03466528|"~     Patients who suffer Alcohol Use Disorder (AUD) have a 30-80% incidence of thiamine deficiency~     causing Wernicke's Encephalopathy (WE).~      Intravenous (IV) thiamine replacement is standard practice in the treatment of alcoholic~     patients presenting to the Accident & Emergency (A&E) department, however routine~     co-supplementation with magnesium (administered IV as magnesium sulphate ), which is required~     as a co-factor for thiamine in some metabolic processes, e. g. on the activity of the enzyme~     transketolase in red blood cells, is not routine practice in the treatment of these patients.~     Without correction of concomitant magnesium deficiency there may be impaired utilisation of~     thiamine resulting in a failure to treat WE.~      This study is designed to determine if administration of magnesium to AUD patients affects~     red cell transketolasae and serum lactate concentrations by itself, or only acts to increase~     the effect of thiamine on the activity of this enzyme.~   "
7665|NCT03466515|"~     A pilot study to investigate the safety and feasibility of stem cells treatment of complex~     anal fistula in patients with Crohn`s disease.~   "
7666|NCT03466502|"~     This study will assess the efficacy of oral vancomycin prophylaxis in preventing recurrent~     Clostridium difficile infection in hospitalized patients requiring oral or intravenous~     antibiotics for a suspected or confirmed bacterial infection.~   "
7667|NCT03466489|"~     Infection after total joint arthroplasty can have devastating consequences. Adhesive drapes~     have been traditionally used at our institution to help reduce the risk of wound~     contamination and infection by superficial skin flora. Our primary objective is to determine~     if a cyanoacrylate-based sealant (FloraSeal microbial sealant) is superior to conventional~     iodine impregnated drapes in prevention of both superficial and deep surgical site infections~     in total joint arthroplasty (TJA) patients. A prospective, randomized controlled model will~     be used to answer this question.~   "
7668|NCT03466476|"~     Total Knee Arthroplasty is becoming an increasingly common operation. An important part of a~     successful overall patient outcome is regaining functional range of motion after surgery.~     Wearable devices for fitness have become increasingly common in the general population. This~     study seeks to utilize wearable technology to enhance the post-operative rehabilitation~     experience by allowing patients and surgeons to monitor patient recovery in real time. The~     Consensus TracPatch is a wearable device which utilizes an accelerometer, temperature sensor~     and step count to allow the surgeon and patient to monitor recovery and help ensure critical~     milestones are being met. Our hypothesis is that this new technology will improve patient~     outcomes as it pertains to rehabilitation milestones and overall satisfaction as compared to~     controls who do not utilize this technology.~   "
7669|NCT03466463|"~     This is a Phase 1/2, multinational, open-label, escalating-dose study to evaluate the safety~     and efficacy of an intravenous infusion of GNT0003 in patients with Crigler-Najjar aged ≥10~     years and requiring phototherapy. Patients will received a single administration of GNT0003~     and will be followed for safety and efficacy for 1 year.~   "
7670|NCT03466450|"~     Glioblastomas (GBMs) are the most common malignant primary brain tumors. Despite~     multimodality aggressive therapies (surgery followed by chemoradiotherapy based on TMZ and~     adjuvant TMZ), median overall survival is only 12 to 15 months. This dramatic behavior is~     mainly due to the high invasiveness and proliferation rate of GBM.~      In addition, GBM exhibits a high resistance to standard chemotherapy and radiotherapy.~     Current strategies for the treatment of GBM are only palliative, and include surgical~     resection (which is frequently incomplete due to the proximity of the tumour to vital brain~     structures) and focal radiotherapy. A large number of chemotherapeutic agents (e.g.~     alkylating agents such as TMZ and nitrosoureas such as carmustine) have also been tested, but~     they display limited efficacy.~      The current gold standard first line treatment for glioma for patients less than 70 years old~     includes radiation and concurrent TMZ followed by adjuvant TMZ (i.e., the Stupp regimen).~     However, results are disappointing and there is an unmet medical need of new drugs in this~     setting.~      Glasdegib (SHH pathway inhibitor) is a rational therapeutic agent for patients with newly~     diagnosed Glioblastoma since inhibits SHH pathway interfering with cancer stem cells and~     endothelial migration.~   "
7671|NCT03466437|"~     This study will be a controlled, randomized, parallel group trial where the survival rate of~     direct and indirect restorations on removable partial denture abutment teeth will be~     assessed. For this, individuals with widely destroyed teeth and need for endodontic~     treatment, with at least one remaining dentin wall, adjacent to edentulous spaces in Kennedy~     Classes I and II will be selected. After the minimum period of one year the teeth will be~     reassessed through clinical and radiographic examination annually.~      All patients will receive oral hygiene instructions, caries disease control and endodontic~     treatment according to the need of each case. Prior to post cementation, patients will~     receive endodontic treatment through routine techniques that include use of rubber dam,~     mechanized instrumentation with NaOCl 2%, gutta percha and endodontic cement filling and~     condensation by the McSpadden technique. The preparation for post space will be done with a~     specific bur compatible with the diameter of root canal, and the same preparation cast post~     and cores. The glass-fiber posts (will be cleaned with 70% alcohol and receive silane~     application.~      The clinical protocol for direct restoration and confection of the composite resin core will~     occur in the same way, using the same materials: the dental structure will be etched with 37%~     phosphoric acid and rinsed, followed by the adhesive system and fabrication of the~     restoration by incremental technique according to the manufacturer's recommendations. It is~     important to emphasize that the direct restorative procedure will be carried out in the same~     consultation of the glass-fiber post cementation.~      In order to make the cast metal cores, the indirect impression technique will be done with~     prefabricated pins associated with addition silicone. In this technique, the lightweight~     material will be inserted into root canal and then, the pin will be introduced into the~     canal. Next, a prefabricated tray with the heavy and light material will be positioned for~     removal of the assembly, being removed after the setting time determined by the manufacturer.~     The mold obtained will be sent to the dental technician for cast post and core fabrication.~     All posts will be cemented under rubber-dam isolation using self-adhesive resin cement.~      In teeth where randomization is a metalceramic crown, first the composite resin or metal core~     will be prepared with a 3216 drill, in order to obtain 1.5mm wear on the proximal and free~     faces and 2mm on the occlusal surface. The margin design in form of a chamfer, preferably at~     the gingival level whenever possible. The impression procedure will be carried out using a~     molding cap and polyether, which will be removed in a tray with irreversible hydrocolloid. A~     temporary crown will also be made for the patient. The metallic infrastructure will be tested~     in order to verify its adaptation and transferred in irreversible hydrocolloid molding for~     later ceramic application. After application of the ceramic, the laying and adaptation of the~     prosthetic piece will be conferred, being the crown luted with self-adhesive resin cement.~      Once the restoration / crown of the abutment tooth has been made, the treatment will continue~     with the preparation of the removable partial denture. The teeth will always be prepared in~     the mesial proximal area. The delivery of the removable partial denture will be considered~     the baseline of the study. At this moment, the necessary adjustments and subsequent control~     of the prosthesis will be made after 24, 72 hours, a week and 15 days in order to check for~     possible flaws. After 6 months and 1 year of delivery of the removable partial denture, all~     patients will be recalled for clinical and radiographic evaluation of prostheses /~     restorations and oral hygiene conditions. This monitoring will be conducted by two evaluators~     until the end of the trial.~      All clinical procedures will follow pre-established protocols and the data of each patient~     and intervention will be recorded in the individual patient file.~   "
7672|NCT03466424|"~     Preoperative radiotherapy followed by total mesorectal excision (TME) has been recommended as~     the preferred treatment method for locally advanced rectal cancer. Similar rates of local~     control, survival and toxicity were observed in preoperative long-course radiotherapy (LCRT)~     (45-50.4 Gy in 25-28 fractions) and short-course radiotherapy (SCRT) of 25 Gy in five~     fractions. For the convenience of SCRT, a growing number of patients tend to receive SCRT as~     preoperative radiotherapy. Although SCRT can shorten treatment interval and cut down the cost~     of treatment, it's pathological complete response (pCR) rate is relatively low (SCRT vs.~     LCRT: 0.7% vs. 16%). Hence, the optimal pattern of preoperative therapy of locally advanced~     rectal cancer still deserves to be explored. Previous studies have confirmed the feasibility~     and safety of 30Gy/5 fractions in SCRT of rectal cancer and verified that SCRT followed by~     mFOLFOX6 chemotherapy can improve the pCR rates. Therefore, investigators aimed to establish~     a dose escalation mode of SCRT (5×6Gy/7Gy/8Gy) followed by four cycles of modified~     FOLFOX6(mFOLFOX6) chemotherapy to test the safety and efficacy in treating locally advanced~     rectal cancer.~   "
7673|NCT03466411|"~     The purpose of this program is to evaluate the efficacy and safety of guselkumab in~     participants with Crohn's disease.~   "
7674|NCT03466398|"~     This study will use a randomized, crossover design. Children aged 13-18 years who have been~     diagnosed with Type 1 diabetes for at least 1 year and with at least 2 Hemoglobin A1c values~     ≥10.0% more than 60 days apart within the past year, with the most recent HbA1c value between~     10-14%, will be placed into two separate treatment groups. Group A will undergo home~     monitoring for 12 weeks through the use of the Vivify kit, which contains a wireless tablet~     with daily medication/diet/symptom questionnaires. Group B will initially continue diabetes~     management per standard of care, including quarterly office visits. After a period of 12~     weeks, Group B will switch to the RPM protocol, while Group A will return to standard of~     care. Both groups will have HbA1c values checked at the 0, 3, and 6 month time periods to~     assess the effect of the remote monitoring protocol. Participation in the RPM protocol will~     involve daily completion of the Care Plan questions, as well as weekly uploads of blood~     glucose values using the Glooko, Inc (Mountain View, CA) application, and weekly video visits~     with a member of the endocrinology team that will aim to address barriers to optimal care,~     whether they be motivation, knowledge or other difficulties. Barriers to care will be~     assessed in part through the completion of knowledge and self-efficacy assessments.~   "
7675|NCT03466385|"~     Although non-invasive ventilation (NIV) usage has increased significantly over time in COPD~     exacerbation, a great percentage of patients (~30%) present contraindications to NIV or~     cannot tolerate it. Nasal high flow (NHF) has been introduced for the management of hypoxemic~     respiratory failure in adults with favorable effects on ventilation and respiratory~     mechanics. The above mentioned NHF positive effects has been observed also in stable COPD~     patients with or without chronic hypercapnia.~      In this study, the investigators hypothesize that NHF is not inferior to NIV for respiratory~     support in patients with COPD exacerbation and acute or acute on chronic hypercapnic~     respiratory failure.~   "
7676|NCT03466372|"~     The long-term study goal is to develop a more engaging, motivating gait biofeedback~     methodologies specifically designed for post-stroke gait training. The current project aims~     to address fundamental questions regarding the optimal methodology to deliver AGRF~     biofeedback during gait, and the feasibility and preliminary efficacy of AGRF progression~     protocols for improved gait patterns and gait function. The study objectives are to (1)~     evaluate the immediate effects of biofeedback training methodology on gait biomechanics; and~     (2) evaluate the feasibility and short-term effects on gait performance of a real-time~     biofeedback protocol incorporating progression criteria (similar to those employed during~     clinical rehabilitative training).~   "
7677|NCT03466359|"~     The aim of the present study is to compare the effect of two weight loss interventions~     inducing the same energy deficit but one based on exercise and one using dietary restriction,~     on appetite control in obese adolescents. Investigator hypothesis that daily energy intake~     and hunger will be increased in the dietary restriction group but not in response to the~     exercise program.~   "
7678|NCT03466346|"~     Despite carrying the vast majority of the global mental disorder burden, 75% of adults with~     mental disorders in Low and Middle Income Countries have no access to services. This study~     will test strategies for integrating evidence-based depression treatments with primary care~     services at a large public sector hospital and conduct robust cost and cost-benefit analyses~     of each treatment to produce a menu of cost-benefit options for integrated depression care~     with corresponding effectiveness and implementation values. The project is relevant to the~     mission of the National Institutes of Mental Health because it addresses mental health care~     delivery and related health economics at the individual, clinical and systems levels.~   "
7679|NCT03466333|"~     This is a double blind randomised controlled feasibility study investigating the effect of~     postnatal enalapril on cardiovascular function in women who have had preterm pre-eclampsia.~     Participants will be randomised to 6 months of enalapril or placebo within 3 days of~     delivery. Cardiovascular function will be assessed using serial echocardiography and~     biomarkers.~   "
7683|NCT03466281|"~     In this randomized controlled study in patients with irritable bowel syndrome (IBS) the~     investigators plan to compare the effects of a structured patient group education (IBS~     School) with structured education provided via the internet. The effects of the interventions~     on GI and psychological symptom severity, knowledge and quality of life will be assessed with~     validated questionnaires at baseline, immediately after the intervention and 3 and 6 months~     after the intervention.~   "
7684|NCT03466268|"~     This study evaluates the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of~     SCC244 in patients with advanced solid tumors with c-Met Alterations.~   "
7685|NCT03466255|"~     The investigators plan to evaluate the correlation between carotid plaque enhancement on~     Contrast-enhanced ultrasound (CEUS), significant coronary artery disease (CAD), and~     cardiovascular (CV) outcomes in a systematic manner. The investigators hypothesize that~     increased levels of CEUS-detected vulnerable carotid plaque will be predictive of CV risk~     determined by angiography and future cardiovascular events.~   "
7686|NCT03466242|"~     The primary objective of this study is to evaluate the sedative, and analgesic effects of~     intranasal (IN) Dexmedetomidine (DEX) in children presenting to a Pediatric Emergency~     Department (PED) who undergo conscious sedation for reduction of closed distal forearm~     fractures when compared to those receiving intravenous (IV) Ketamine. The secondary objective~     is to compare each sedation technique for safety and procedural outcomes.~   "
7687|NCT03466229|"~     Increased sperm DNA Fragmentation Index implies decreased male fertility in vivo and in~     vitro. There is need for developing new strategies for improvement of male fertility. The~     study aims to investigate whether high sperm DNA Integration Index can be treated by use of~     antioxidants.~   "
7688|NCT03466216|"~     AlphaMedix™ (²¹²Pb-DOTAMTATE) is a radiotherapeutic drug indicated in subjects with~     unresectable, metastatic somatostatin receptor (SSTR) positive neuroendocrine tumors (NETs).~     Because 212Pb is an in vivo generator of alpha particles, it is particularly suitable for~     SSTR therapy applications.~      This drug addresses an unmet need in the field of peptide receptor radionuclide therapy~     (PRRT) for NETs. Substitution of an alpha emitter (²¹²Pb) for the beta emitters currently~     being used (i.e., 177Lu or 90Y) will provide significantly higher Linear Energy Transfer~     (LET) and a shorter path length. Higher LET particles should cause more tumor cell death.~     Shorter path length should result in less collateral damage of the normal tissue and~     therefore less side effects for subjects receiving the drug.~   "
7689|NCT03466203|"~     The purpose of the study is to evaluate the safety and tolerability of multiple doses of~     LLF580 administered subcutaneously over 3 months in obese subjects. In addition, the study~     will also determine early efficacy signals in various metabolic diseases associated with~     elevated triglycerides and/or obesity.~   "
7690|NCT03466190|"~     Two groups of patients with mandibular body fractures indicated for Open reduction internal~     fixation alone or in combination with fractures elsewhere in the mandible or midface. First~     group will be subjected to traditional titanium internal rigid fixation. Second group will be~     subjected to custom made PEEK plates.~   "
7691|NCT03466177|"~     Because of a shared ontogenic origin, the retina displays similarities to the brain and~     spinal cord in terms of anatomy, functionality, response to insult, and immunology. Hence,~     the retina can be approached as an integral part of the central nervous system. The occurence~     of ocular manifestations in several neurodegenerative pathologies, such as Alzheimer's~     disease and Parkinson's disease, accentuates the strong relationship between eye and brain.~     Particularly retinal changes can present a substrate for cerebral changes in these disorders.~     Offering a 'window to the brain', the transparent eye enables non-invasive imaging of these~     changes in retinal structure and vasculature. In this project, the potential of retinal~     biomarkers for e.g. Alzheimer's will be explored with the aim to overcome some of the hurdles~     in the current management of these pathologies, mainly the lack of techniques for patient~     screening and early diagnosis. The aim of this clinical trial is to correlate the retinal~     biomarkers for Alzheimer's with neuro-imaging, and cognitive function. Integrating the~     results will yield non-invasive retinal biomarkers for clinical research, screening, and~     follow-up of disease progression in various neurodegenerative disorders.~   "
7692|NCT03466164|"~     This project focuses on understanding the cognitive and neural mechanisms by which~     mindfulness training (MT) results in positive behavioral change and enhanced psychological~     well-being. Participants will complete two sets of cognitive tasks during functional magnetic~     resonance imaging (fMRI) and either be assigned to an MT intervention between scan sets or~     after scan sets.~   "
7693|NCT03466151|"~     It is a randomized controlled trial to evaluate the safety and efficacy of the Medtronic~     Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in comparison with the Medtronic~     Resolute Integrity™ Zotarolimus-Eluting coronary stent system in the treatment of subjects~     eligible for percutaneous transluminal coronary angioplasty (PTCA) in China.~   "
7694|NCT03466138|"~     The proposed study is designed to further demonstrate the performance of the Nociception~     Level (NoL) Index - in surgical patient under general anesthesia, by evaluating its response~     to controlled changes in the levels of noxious stimuli/analgesia and to correlate early~     outcome predictors to the NoL values throughout the surgical procedure, thus provide the~     medical caregiver general recommendations on how to interpret the NoL Index in terms of~     magnitude and direction, and how to utilize it during the surgical procedure.~   "
7695|NCT03466125|"~     The purpose of the research is to identify the frequency and severity of adverse events~     related to atrial fibrillation that occur after discharge from hospital where the patient~     underwent cardiac surgery.~      The Specific Aims of the proposed study are to:~        1. Identify the predictors of postoperative atrial fibrillation after discharge from~          hospital.~        2. Identify the frequency of readmission to hospital, or other resource use such as~          Emergency Department or outpatient visit, for the treatment or prophylaxis of~          postoperative AF and consequent stroke or bleeding outcomes.~        3. Identify the risks for stroke, death and other morbidity in patients after cardiac~          surgery and the effect of postoperative AF upon subsequent stroke or bleeding outcomes.~   "
7696|NCT03466112|"~     The study investigates the efficacy of aerobic exercise on cognitive performance and brain~     plasticity in remitted early phase schizophrenia.~   "
30901|NCT03162575|"~     The current study aims to investigate the efficacy of Mindfulness-Based Cognitive Therapy~     (MBCT) for reducing fatigue in Inflammatory Bowel Disease patients in remission.~   "
7697|NCT03466099|"~     This is a clinical study where patients with diabetes and a vision threatening eye condition~     called Diabetic Macular Edema receive four injections into the eye at monthly intervals.~     The patients will already have tried the standard of care without complete success. The~     patients will be randomized to receive either a high dose, a low dose or a sham control~     treatment. The study will evaluate whether the new treatment improves vision and whether it~     changes the underlying course of the disease in the eye.~   "
7698|NCT03466086|"~     This clinical study is a randomized, double-masked, cross-over, bilateral, 2 treatment x 2~     period, dispensing 4-visit study with a 7-9 day washout period in between visits 2 and 3. The~     study will last approximately 3 months.~   "
7699|NCT03466073|"~     A Phase 1b/2a, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the~     Safety, Pharmacokinetics, and Pharmacodynamics of Recombinant Human Plasma gelsolin~     (rhu-pGSN) Added to Standard of Care in Subjects Hospitalized for Acute Community-acquired~     Pneumonia (CAP)~   "
7700|NCT03466060|"~     This is a multi-site, randomized, double-masked, contralateral, 2 treatment x 2 period~     crossover, dispensing, five-visit study to gain clinical insights of the study lenses and~     solutions.~   "
7701|NCT03466047|"~     This study is part of a research theme aiming at elucidating the physiological mechanisms of~     action of weight loss after gastric bypass surgery. The Roux-en-Y Gastric Bypass procedure~     induces pronounced and sustained weight loss, but the physiological mechanisms of action are~     not completely clear. Neither mechanical restriction of food intake nor malabsorption, are~     the main contributing factors. The enhanced postprandial responses of gut hormones (e.g.~     GLP-1 and PYY) which increase satiety as well as energy expenditure after surgery suggest a~     changed physiological set point for appetite and metabolism.~      Our hypothesis is that the intake of high quantity of protein in a microcapsule form would be~     able to reach the distal parts of the intestinal mucosa and stimulate maximum stimulation of~     the anorectic gut hormones. The higher functions of the brain will respond to these strong~     neuroendocrine signals by ensuing satiety and fullness.~   "
7702|NCT03466034|"~     The study aims to develop scans that tell the investigators about the oxygen content of~     tumours using Magnetic Resonance Imaging (MRI) and seeing whether regions of low oxygen~     content are related to mutations in cancer genes such as TP53. MRI is a method of obtaining~     pictures of inside of the body that shows the appearance and structure of soft tissues.~      To get the information about the oxygen content of tumours, MRI is carried out while~     breathing 100% oxygen. The variation of oxygen supply to different regions of the tumour will~     help the investigators to predict tumour behavior and tumour response to treatment.~   "
7703|NCT03466021|"~     The study is a 44 weeks, prospective, randomized, placebo-controlled, double-blinded,~     parallel group two-center trial. Forty patients are recruited among the outpatients of the~     chronic obstructive pulmonary disease (COPD) clinic, Hospital of South West Jutland and~     Lillebælt Hospital according to the inclusion and exclusion criteria. The patients are~     randomized to receive liraglutide 3 mg per day (initial dose 0.6 mg, increasing by 0.6 mg~     weekly until 3 mg is reached) or placebo. At baseline, after four weeks (assessment of the~     acute effect of liraglutide), 20 weeks, and 40 weeks (assessment of the combined effect of~     liraglutide and weight loss) and at week 44 (assessment of the weight-loss after~     discontinuation of liraglutide) the patients are assessed by physical examination, carbon~     monoxide (CO) diffusion test, pulmonary function test, biomarkers of inflammation (CRP,~     interleucine-6 (IL-6), monocyte chemitactic protein-1 (MCP-1)), Fluorodeoxyglucose~     (FDG)/PET-CT scan of the lungs, 6-minute walking test, respiratory polygraphy and validated~     questionnaires including basic dyspnea index, transition dyspnea index, COPD Assessment Test~     (CAT)-score, short-form-36 (SF-36) and Epworth Sleepiness Score.~   "
7704|NCT03466008|"~     Our aim was to determine whether Whole Body Cryotherapy (WBC) can result in improved pain~     status, perceived health, and quality of life in patients with fibromyalgia. It is~     hypothesized that this positive effect can be achieved through increased functional mobility~     and decreased pain intensity resulting from cold-induced modulation of the~     inflammation-immune axis.~   "
7705|NCT03465995|"~     The long term goal for the Traumatic Injury Research Program (TIRP) is testing of novel~     devices for the identification and longitudinal assessment of traumatic brain injury (TBI).~     DoD (United States Department of Defense) has now tasked TIRP with the test and evaluation of~     these devices to assess reliability and validity. The objective of this effort is to test the~     reliability of the NKI, Inc, (NeuroKinetics, Inc) i-PAS device using a test/re-test protocol~     with healthy controls.~      The research design is test/re-test, with three assessments obtained on three separate~     visits. This will allow the assessment of reliability of both the device and the measure(s)~     that are computed from the input signals. Participants will be Healthy Controls (HC) as~     defined in the inclusion exclusion section.~      In this initial study, investigators will be administering standardized self-report~     instruments (Standard Form 36 - SF36, and Symptom Checklist 90r, or SCL-90r), standard~     three-lead EKG. In addition they will administer the NKI i-PAS specific protocol as~     delineated by NKI.~   "
7706|NCT03465982|"~     The trial is a multicenter, prospective, randomized controlled, unblinded, parallel-group~     trial comparing standard and delayed surgery after neoadjuvant chemoradiotherapy for the~     curative treatment of rectal cancer. Three-hundred and thirty-two patients will be randomized~     on an equal basis to either robotic-assisted/standard laparoscopic rectal cancer surgery~     after 8 weeks or robotic-assisted/standard laparoscopic rectal cancer surgery after 12 weeks.~     The recruiting interval will be of 5 years and the follow-up period will end 5 years after~     the last patient is randomized.~   "
7707|NCT03465969|"~     The purpose of this study is to assess relationship between tacrolimus concentrations~     determined via whole blood MITRA assay method with those determined using the established and~     validated whole blood venepuncture method using samples taken from liver and kidney~     transplant participants.~   "
7723|NCT03465761|"~     The objective of this prospective, multi-site, single-arm, open-label study is to capture the~     safety and efficacy(performance) of bilateral staged Exablate treatment in subjects with~     bilateral medication-refractory essential tremor (ET). . The staged second procedure will be~     performed at least9 months post contralateral side. The benefit of real-time feedback will~     allow the physician to maximize benefit without jeopardizing safety.~      This study is designed as a prospective, open-label, single arm, multi-site study design.~   "
7708|NCT03465956|"~     Laparoscopic Sleeve Gastrectomy (LSG), Also known as longitudinal or vertical gastrectomy.~      LSG was initially considered a first-stage operation in high-risk patients before~     bilio-pancreatic diversion or Roux-en-Y gastric bypass surgery. However, LSG was subsequently~     found to be effective as a single procedure for treatment of morbid obesity.LSG functions~     mainly as a restrictive procedure in which about 75 % of the stomach is removed leaving a~     narrow gastric tube or sleeve. So, it limits the amount of food that can be eaten at one time~     via inducing early satiety after eating a small amount of food due to early distension of the~     fashioned gastric sleeve giving a sense of satiety, consequently losing excess body weight by~     time.Sleeve gastrectomy may also cause a decrease in appetite by reducing the amount of~     Ghrelin (hunger hormone) produced by the stomach.~   "
7709|NCT03465943|"~     The aim of this study was to compare between crystalloid versus crystalloid and colloid~     combination preloads for prevention of hypotension following intrathecal anaesthesia in~     patients undergoing elective Caesarean section.~      To examine weather baseline perfusion index could predict the incidence of~     intrathecal-induced hypotension during Caesarean section.~   "
7710|NCT03465930|"~     Lymphedema, primary or secondary, is a chronic disease that causes functional impairment and~     has an important impact on patient's quality of life. Lymphedema can be primary or secondary.~     Secondary lymphedema, which is more common, especially in industrialized countries, is often~     due to surgery and radiotherapy to treat cancer. There is no definite cure for lymphedema;~     conservative treatments such as elastic compression garments, bandages and manual lymphatic~     drainage help reducing the edema but do not resolve it. Many types of surgery have been used~     in the past, the most recent are lymphatic-venous anastomoses, a minimally invasive procedure~     that may be performed under local anesthesia. Briefly, after visualizing the lymphatic~     vessels with a fluorescent dye, one or more anastomosis are created between collecting~     lymphatic vessels and superficial veins in order to drain the lymph into the blood stream~     bypassing the obstacle. During this procedure, it is possible to take samples of the~     collecting lymphatic vessels that are to be anastomosed with veins and use them for~     histological and immunohistochemical studies, without causing any additional discomfort to~     the patient. These samples can be formalin fixed and paraffin embedded. The obtained sections~     will be stained with a lymphatic endothelium marker and a smooth muscle specific stain. A~     morphometric study will be conducted and, based on the results a statistical evaluation will~     be made. The analysis will be conducted on samples obtained from patients, affected by~     secondary or primary lymphedema willing to provide their free and informed consent. The aim~     of this study is to evaluate the histopathological characteristics of the collecting~     lymphatic vessels that have been anastomosed with adjacent veins during surgery, and relate~     the results with the obtained clinical response. The acquired knowledge will contribute to~     optimize the clinical approach to prevent and treat lymphedema, by helping to select the~     patients that will benefit more from the surgery, and to select vessels and anatomical sites~     that have better chances to provide efficient anastomoses.~   "
7711|NCT03465917|"~     Hypertension is a major risk factor for heart disease and stroke, two of the leading causes~     of death in the United States. Hypertension is a common and widespread problem;~     unfortunately, current treatment strategies fail to adequately control blood pressure in up~     to 50% of patients either because of failure to take prescribed medications (because of cost,~     side effects, inconvenience etc.) or lack of therapeutic response. Indeed, it is estimated~     that 50% of patients stop taking antihypertensive medication within 6-12 months after the~     initiation of drug therapy.~      Despite enthusiasm for a novel approach called renal denercation, presently there are no~     integrative studies of the antihypertensive effect of renal denervation on the multiple~     regulatory pathways it may consequentially affect. Experimental evidence from pre-clinical~     models suggests the effects are due to reducing efferent sympathetic activity and thus~     lowering blood pressure by altering the renin-angiotensin system. Uncontrolled clinical~     studies in humans suggest that when effective, this procedure may also lower renal~     sympathetic nerve activity. However the sympathetic response to monopolar radiofrequency~     therapy has been highly variable. Moreover, there have been no assessments of procedural~     efficacy performed in humans. Thus the actual mechanism by which this type of procedure~     reduces BP in humans is largely unknown, making it extremely difficult to identify the~     appropriate patients for this invasive procedure.~      Recently, chemical renal denervation using ethanol (EtOH), was demonstrated to markedly lower~     blood pressure in small numbers of patients with resistant hypertension. However the~     mechanisms by which blood pressure is altered using this novel technique in humans is~     entirely unknown, and procedural efficacy has also not been assessed. Therefore it is~     unclear, whether in humans renal sympathetic nerve activity is lowered following renal~     denervation using this new approach. The Investigators propose to use high resolution~     physiological testing to determine the effects of chemical renal artery denervation on~     sympathetic activity.~      Therefore the global objective of this physiological study is to provide the first detailed~     assessment of the integrated mechanistic effects of chemical renal nerve denervation in~     humans with hypertension that is uncontrolled by conventional treatment (because of lack of~     adherence or response to therapy).~   "
7712|NCT03465904|"~     The main objective of this study is to have Phase III evidences of the efficacy of the~     Cefaly® Abortive Program device used at home for 2 hours to treat a migraine attack. This~     randomized, double-blind, sham-controlled trial will study the abortive treatment of migraine~     using the Cefaly® Abortive Program device.~   "
7713|NCT03465891|"~     The purpose of this study is to compare the safety and effects of atezolizumab with low dose~     radiation on people with relapsed or refractory follicular lymphoma, In this study, the~     patient will get either atezolizumab with low dose radiation or, atezolizumab alone. To be~     better, the atezolizumab and low dose radiation should increase life by 1 year or more~     compared to the usual approach.~   "
7714|NCT03465878|"~     The purpose of this study is to compare LY900014 with insulin lispro (Humalog) in~     participants with type 1 diabetes mellitus.~      There are 2 parts to this study. Part A is investigating how the body processes LY900014 and~     the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog) when study~     treatment is given by subcutaneous injection. Part B of the study is investigating how the~     body processes LY900014 and the effect of LY900014 on blood sugar levels compared to insulin~     lispro (Humalog) when study treatment is given by continuous subcutaneous insulin infusion~     (CSII) pump.~      Screening is required within 28 days prior to the start of the study. For each participant,~     the study will last about 40 days in each part.~   "
7715|NCT03465865|"~     ILM-flap transposition is a new surgical option in repair of macular holes, therefore one~     year outcomes are needed to better evaluate that method.~   "
7716|NCT03465852|"~     Wake Forest University and its partners, Triad Health Project, and the University of North~     Carolina, Greensboro, will be evaluating the effectiveness of ChiCAS (Chicas Creando Acceso a~     la Salud or Girls Creating Access to Health), a locally developed, Spanish language small~     group behavioral intervention that promotes access to and participation by Hispanic/Latina~     transgender women who are HIV negative and who have sex with men in pre-exposure prophylaxis~     (PrEP), medically supervised hormone therapy, and consistent condom use.~   "
7738|NCT03465566|"~     The social processes depend on complex cognitive mechanisms, which involve mainly the frontal~     and temporal lobe regions. Patients with early onset frontal and temporal lobe lesions might~     later develop important deficits in social integration. Accordingly, children with early~     onset temporal lobe epilepsy (TLE) demonstrate altered emotion recognition.~   "
7739|NCT03465553|"~     The study wants to define the maximum tolerated dose (MTD), safety and efficacy of a short~     course radiation therapy in patients with symptomatic advanced thoracic cancer.~   "
7740|NCT03465540|"~     Evaluate the safety and tolerability of AMG 397. Estimate the maximum tolerated doses (MTDs)~     and/or biologically active doses.~   "
7717|NCT03465839|"~     Nursing handovers are performed 2-3 times a day for each patient, with an approximate average~     of 2 million nursing deliveries per year in a hospital of medium size. Nursing handovers are~     considered essential for the continuity and safety of care. If the relevant clinical~     information is not shared in a precise and timely manner, it may worsen the patients'~     outcomes with an increase in adverse events, delays or inappropriate treatment until the~     omission of procedures.~      The modality of nursing delivery presents, therefore, a gap of vulnerability where vital~     information could not be considered and systematically shared.~      Patients should be involved in their care to promote a patient-centred approach. The~     involvement of patients in handovers is effective compared to other delivery methods.~      To date, however, the best mode to deliver handovers was still unclear due to a systematic~     lack of studies to identify the best practice of nursing handovers. The studies in the~     literature lack of sound methodologies due to not randomized designs.~      Thus an intervention to improve quality of handovers and to implement bedside handovers in~     surgical wards will be performed.~      The following hypotheses were made:~        -  The introduction of nursing bedside handovers will improve the quality of the~          information exchanged.~        -  The educational intervention training intervention will positively modify the nursing~          handovers.~        -  There is a relationship between the qualitative level of nursing handovers and working~          status (expert vs novice) of the nurses.~        -  There is a relationship between the qualitative level of nursing handovers and the~          patients' characteristics.~   "
7718|NCT03465826|"~     This ClinicalTrials.gov record pertains only to the clinical trial described below in Aim 4.~     Aims 1-3 and 5 are described here as background information. This study will be a two-site~     collaborative research effort (Wake Forest & Duke Univ.) drawing on expertise of~     investigators steeped in PCST, Internet-based treatment delivery, and development of~     cost-efficient and maximally-accessible behavioral interventions for migraine and chronic~     pain. This research will address four specific aims via a mixed-methods approach. In Aim 1~     subjects (n=20) will be recruited to participate in user testing of the extant program~     (PainCOACH1). In Aim 2 subjects (n=64, including migraineurs, members of migraine patient~     advocacy groups, and clinical professionals trained in headache medicine) will participate in~     focus groups to provide guidance for appropriately tailoring the program for the treatment of~     chronic migraine. In Aim 3 feedback from Aims 1 and 2 will be employed to build and develop~     PainCOACH Migraine which will be beta-tested and refined. In Aim 4 subjects (n=144) will be~     recruited to participate in a randomized, controlled trial of the PainCOACH Migraine program~     (versus Medical Treatment as Usual) to demonstrate its feasibility, acceptability and~     engagement, and promise. Guided by findings from these aims a final exploratory aim will be~     conducted to optimize the program using prediction models to identify patients at risk for~     poor outcomes or attrition, and an adaptive therapeutic process targeting improved outcomes~     for such patients. Ultimately these research efforts will provide data and experience needed~     to support a subsequent large-scale and methodologically rigorous adaptive trial to test~     PainCOACH Migraine and enhance understanding of the potentials for Internet-based delivery of~     behavioral programs for individuals with chronic migraine.~   "
7719|NCT03465813|"~     Of the 3.1 million U.S. breast cancer survivors, approximately 30% experience significant~     cancer-related distress ranging from sub-threshold to diagnosable adjustment disorders,~     depression-symptoms and major depression up to 20 years after diagnosis. Rural cancer~     survivors report poorer mental health than urban survivors. Lack of access to care, support~     and stigma associated with cancer and mental health, challenge rural women's ability to~     prevent cancer-related distress and its deleterious outcomes. These barriers may be overcome~     by a new Internet-based, psychoeducational program designed for newly diagnosed women;~     CaringGuidance™- After Breast Cancer Diagnosis. This self-guided program provides~     information, cognitive-behavioral and supportive coping strategies in a text/audio/visual~     format accessed via Internet/mobile devices to increase understanding, and provide supportive~     tools to prevent/manage distress and depressive-symptoms.~      The aims of this pilot study are to determine preliminary efficacy of the CaringGuidance™~     program on distress and depressive-symptoms monthly and over 3 months, for rural women newly~     diagnosed with breast cancer, and trial measures and methods, prior to a fully powered RCT.~      Sixty rural women, will be randomized to 3 months of self-guided CaringGuidance™ program~     access with usual care or usual care alone. Both groups complete monthly standard~     psychosocial measures, daily activity/symptom logs and receive a monthly call. Program~     engagement/dose will be measured by the CaringGuidance™ internal data system. Descriptive and~     inferential statistics will characterize the sample and determine differences between groups~     at monthly intervals and overall. Variability of outcome variables will also be assessed to~     determine usefulness.~   "
7720|NCT03465800|"~     This research seeks to examine psychological factors that may impact relationship between~     incentives and health behavior engagement, specifically physical activity. Additionally, it~     will compare the impact of two different incentive schedules on behavior engagement, one~     providing immediate rewards (i.e. rewards received on a daily basis) and another providing~     delayed rewards (i.e. rewards received at the end of the study period), with an active~     self-monitoring intervention condition in which no rewards are offered. Study participants~     will provide reports of their physical activity each day for three weeks, and in the two~     incentive conditions, they will receive small monetary rewards for their physical activity.~     Following the three week reporting and reward period, participants will complete two~     additional assessments, measuring psychological constructs and behavior engagement following~     the cessation of rewards. The study will also examine how cognitive and anthropomorphic~     factors may contribute to intervention response and the effects on psychological constructs.~   "
7721|NCT03465787|"~     This is a study designed to evaluate the efficacy and safety of lurasidone in acutely~     psychotic patients with chronic schizophrenia and to confirm the non-inferiority of~     lurasidone relative to quetiapine XR.~   "
7722|NCT03465774|"~     Indwelling pleural catheters (IPCs) are commonly used to treat pleural effusions (build-up of~     fluid in the lungs). Doxycycline is an antibiotic that is also used to treat pleural~     effusions. The goal of this clinical research study is to learn if adding doxycycline to the~     use of an IPC can lead to shorter treatment times with IPCs.~      This is an investigational study. Doxycycline and IPCs are FDA approved and commercially~     available for the treatment of different types of infections and pleural effusions. Either or~     both can be done even if you do not take part in this study as part of your regular care. It~     is consider investigational to compare the results of IPC alone and IPC plus doxycycline.~      The study doctor can describe how the IPC and doxycycline are designed to work.~      Up to 208 participants will take part in this study. All will be enrolled at MD Anderson.~   "
7741|NCT03465527|"~     A phase 2 trial of pre-phase treatment before R-CHOP chemotherapy in elderly patients with~     newly diagnosed DLBCL~   "
7742|NCT03465501|"~     Comparative retrospective study of two anal canal brachytherapy techniques aimed at boosting~     [low dose rate (LDR) and high dose rate (HDR)]~   "
7724|NCT03465748|"~     The high prevalence of myopia - especially in Asian countries - is well documented, as are~     the sight-threatening complications of high or degenerative myopia. Retinal detachment,~     glaucoma, vitreal degeneration and focal retinal changes may occur secondary to the~     progressive axial elongation of the eye with age. Specialty rigid lenses have long been shown~     to lessen this progression in the pediatric population; orthokeratology (ortho-k) lenses are~     worn at night and change the corneal topography to correct low to moderate amounts of myopia.~     Most of the studies on orthokeratology were conducted on Asian children. To the best of the~     investigators knowledge, no study has been done on African American (AA) children. The~     investigators' project seeks to investigate the efficacy of ortho-k in slowing axial~     elongation and myopic progression in AA children compared to that in other races.~   "
7725|NCT03465735|"~     The Researchers are studying whether a vascular boot warming program plus standard of care~     anticoagulation can be a safe and effective method to resolve Deep Vein Thrombosis (DVT)~     ±Pulmonary Embolism (PE) earlier and prevent development of post-thrombotic syndrome (PTS).~     Additionally, to learn whether a more detailed imaging of the affected lower extremities will~     provide a more accurate and reliable method to guide treatment for this condition.~   "
7726|NCT03465722|"~     This is an open-label, randomized, Phase 3 study in patients with locally advanced~     unresectable or metastatic GIST (advanced GIST) of avapritinib (also known as BLU-285) versus~     regorafenib in patients previously treated with imatinib and 1 or 2 other TKIs.~   "
7727|NCT03465709|"~     Safety Assessment of APL-2 in Patients with Neovascular AMD~   "
7728|NCT03465696|"~     Biologic medications have revolutionized the treatment of inflammatory diseases such as~     moderate-to-severe psoriasis. Though very effective with an excellent safety profile,~     patients may be apprehensive about choosing a biologic medication for a variety of reasons.~     The purpose of this research study is to learn more about patient's perception of certain~     psoriasis treatment options.~   "
7729|NCT03465683|"~     The aim of this research project is to investigate the transmission of ESBL-producing~     Enterobacteriaceae on both, the level of bacterial strains and mobile genetic elements, and~     to determine the source of hospital-acquired infections.~   "
7730|NCT03465670|"~     Backround: No data on the adjunctive effects of hyaluronic acid (HA) in a post-surgery,~     chlorhexidine (CHX) - based plaque control regimen are available. Also, contrasting evidence~     is available regarding the efficacy of CHX-based formulations containing anti-discoloration~     system (ADS). The aim of the present study was to evaluate the post-surgery gingival healing~     as well as plaque, gingival inflammation, and staining levels following the use of a 0.2%~     chlorhexidine (CHX) solution with or without anti-discoloration system (ADS) and 0.2%~     hyaluronic acid (HA).~      Methods: Patients undergoing flap surgery at sites with an intact or reduced but healthy~     periodontium participated in a parallel-arm RCT. After surgery, patients used the assigned~     mouthrinse (CHX+HA+ADS or CHX) for 21 days. At day 7 and 21, the Gingival Healing Index (GHI)~     was used to assess the quality of flap closure at the interdental papilla. Plaque index~     (PlI), Gingival Index (GI), Angulated bleeding score (AngBS), tooth and tongue staining were~     also assessed.~   "
7731|NCT03465657|"~     Previous evidence shows that sodium intake in Spanish adult population is over the~     recommended limits and this high sodium intake is related with difficulties in body weight~     control and blood pressure control.~      The aim of this study is to stablish a direct relationship between salt intake and the health~     parameters previously mentioned in a representative sample of Spanish schoolchildren between~     7-11 years old. The investigators are applying a 3-day dietary records to collect dietary~     data, and collecting 24-h urine samples in order to analyse biochemical indicators of sodium~     intake and other nutrients. Anthropometric data are also being recorded and body composition~     is also analysed using bioimpedance technique.~   "
7732|NCT03465644|"~     This study evaluates the efficacy and safety of tailored antithrombotic therapy with early~     (<6-month post-PCI) intensified (low-dose ticagrelor [120 mg loading, then 60 mg bid~     maintenance] and aspirin) and late (>6-month post-PCI) deescalated (clopidogrel alone)~     strategy in patients undergoing high-risk complex PCI as compared with standard Dual~     Antiplatelet Therapy(aspirin and clopidogrel for 12 months).~   "
7733|NCT03465631|"~     The aim of this study to investigate the effect of combined bilateral tDCS and VR-based~     therapy on distal upper extremity training in patients with stroke. We hypothesized that~     experimental group (VR-based training with dual-tDCS) would improve distal upper extremity~     function rather than control group (VR-based training with dual sham tDCS).~   "
7734|NCT03465618|"~     The purpose of this study is to test if PET scans using 89Zr-DFO-cRGDY-PEG-Cy5-C' dot~     particles, can be used to take pictures of brain tumors. The investigators want to understand~     how the particles are distributed and removed from the body, which may help others be treated~     in the future. This will be the first time that 89Zr-DFO-cRGDY-PEG-Cy5-C' dot particles are~     being used in people. The amount of particles given in this study is very small compared to~     the amount that was used in mice animal studies.~   "
7735|NCT03465605|"~     Frailty is known as an independent risk factor for morbidity and mortality in older cardiac~     patients, including patients with congestive heart failure. It is an important factor taken~     into the cardiologists decision making in the clinic, and influences the intensity of follow~     up treatment, invasive intervention and the need to ensure a stronger social support system~     for the patient. Frailty assessment is usually made subjectively by the cardiologist, known~     in the literature as eyeball testing.~      In this study the investigators will compare the cardiologists subjective eyeball testing to~     objective frailty assessment tests based on Fried score and Edmonton frail scale~   "
7736|NCT03465592|"~     This research is being done to find out if an investigational drug, Nivolumab, can be safely~     administered after a half-matched (haplo) bone marrow transplant (BMT), and if the~     investigational drug will help to prevent or delay relapse or progression of sarcomas. In~     this study investigators will also be trying to learn more about how the investigational drug~     changes blood and/or tumors. Participants are eligible for this trial if they have recently~     undergone a half-matched (haplo) bone marrow transplant and have either relapsed or are at~     high risk to relapse.~   "
7737|NCT03465579|"~     BIOPSTAGE is a prospective, non-randomized, diagnostic, multi-cohort investigational study to~     evaluate the impact of pelvic Multi-parametric 3-Tesla magnetic resonance imaging (mp-3TMRI)~     and whole-body 68Ga-PSMA PET/CT for diagnosis of clinically-significant prostate cancer and~     pre-surgical staging.~   "
7743|NCT03465488|"~     Soil-transmitted helminths (STHs) are a group of parasitic worms that infect millions of~     children in sub-tropical and tropical countries, resulting in malnutrition, growth stunting,~     intellectual retardation and cognitive deficits. To control the morbidity due to these worms,~     school-based deworming programs are implemented, in which anthelminthic drugs are~     administered to children without prior diagnosis. The continued fight against these worms is~     aided by the London declaration on neglected tropical diseases, which helps sustain and~     expand global drug donation program, resulting in an unprecedented growth of deworming~     programs. However, the high degree of drug pressure makes deworming programs vulnerable to~     the development of anthelmintic resistance because they only rely on one drug with sometimes~     suboptimal efficacy and there is no availability of alternative drugs. Moreover, at present,~     there is no surveillance system to monitor the emergence and spread of anthelmintic~     resistance. It remains unclear to what extent the efficacy of drugs may have dropped and~     whether anthelmintic resistance is already present.~      This project aims to strengthen the monitoring and surveillance of drug efficacy and~     anthelmintic resistance in STH programs. As such, it will support deworming programs in their~     quest to eliminate STHs as a public health problem.~      The specific objectives of the first work package are to validate diagnostic tools to monitor~     drug efficacy and the spread of anthelmintic resistance, and to validate molecular markers~     for benzimidazole resistance.~      This study will be conducted at four different sites (Ethiopia, Tanzania, Lao PDR and Brazil)~     and will focus on school-aged children (age 5-14). At baseline subjects will be asked to~     provide a recent stool sample which will be processed using 3 different microscopic~     techniques (KK, Mini-Flotac and FECPAKG2). All children will be treated with a single-oral~     dose of albendazole (ALB) 400 mg and 14-21 days after treatment, a second stool sample will~     be collected from all children to again determine the fecal egg counts. At each sampling,~     stool is stored in preservative. Stored stool will be shipped to Belgium for DNA extraction~     and quantitative PCR (qPCR) analysis. A subset of the samples will be analysed by~     pyrosequencing to evaluate the single nucleotide polymorphisms in the b-tubulin gene. Pooling~     of the stored samples will also be performed to compare with the values obtained from~     analysing individual samples.~   "
7744|NCT03465475|"~     Inhalation agents constitute the major part of anesthetic drug costs (20% - 25%) and a~     significant portion of the applied inhalation agents are thrown into the atmosphere through~     the waste gas system without being absorbed by the patient. The amount of waste gas is~     directly correlated to the fresh gas flow (FGF). Reducing the TGA during general anesthesia~     reduces the consumption of inhalant agents and contributes to the reduction of greenhouse gas~     pollution. Risks such as hypoxia, hypercapnia, inadequate depth of anesthesia and potential~     toxic gas accumulation were associated with low flow anesthesia, but the patient was provided~     with adequate safety by following pulse oximetry, capnography, FiO2 and anesthetic gas~     analysis. We aimed to perform anesthetic cost analysis in fresh gas flow (5 and 10 mL/kg)~     determined according to ideal body weight.~   "
7745|NCT03465462|"~     The aim of the study was to evaluate the effects of hypotensive treatment combined with a~     higher zinc supply in the diet and supplements on the mineral status and selected biochemical~     parameters of newly diagnosed hypertensive patients on monotherapy.~   "
7746|NCT03465449|"~     We are studying the feasibility, acceptability, and outcomes of an intervention called~     chronic kidney disease -palliative care (CKD-PC). CKD-PC is a palliative care-based dialysis~     decision-making intervention that involves educating patients and caregivers about dialysis~     and engaging them in shared decision-making. Half of the enrolled patients will receive~     CKD-PC and the other half will receive Usual Care.~   "
7747|NCT03465436|"~     The purpose of this study was to determine how two doses of lasmiditan affected the heart in~     healthy participants. The study also evaluated how much lasmiditan got into the blood stream~     and how long it took the body to get rid of it. Information about side effects was collected.~     The study lasted a maximum of 46 days for each participant, not including screening.~   "
7748|NCT03465423|"~     Investigators hypothesized that propofol dose for pituitary somatotroph patients might differ~     from nonfunctioning pituitary tumor, and investigators will evaluate a target controlled~     infusion (TCI) effect site concentration (Ce) of propofol for BIS score of 40 and LOC (loss~     of consciousness) in pituitary somatotroph patients in comparison with non functioning~     pituitary tumor patients.~      On arrival in the operating room, standard monitoring devices, including electrocardiogram,~     pulse oximetry, noninvasive blood pressure cuff, and bispectral index (BIS) will be applied~     to the patients. Propofol with the modified Marsh pharmacokinetic parameters using a keo of~     1.2/min will be administered through TCI pump (OrchestraBase Primea, Fresenius Vial, France).~     The initial target Ce of propofol will be chosen as 3.0 mg/mL (0.5 mg/mL of incremental size)~     based on an earlier study.~      The sedation of patients will be assessed with BIS score and the modified observer's~     assessment of awareness and sedation (OAA/S). LOC was defined as an OAA/S lower than 2 (loss~     of response to spoken command to eye opening and loss of response to mild prodding or~     shaking). The primary end point of this study is the Ce of propofol when the BIS score is 40.~     The secondary end point of this study is the Ce of propofol at LOC.~   "
7749|NCT03465410|"~     The pharmacokinetics of tacrolimus (TAC) are characterized by high inter- and~     intra-individual variability with narrow therapeutic range. Currently, the limiting point of~     Tac drug monitoring is the inability to individualize doses during the first few days after~     transplantation. Our group developed a population pharmacokinetic model (PPK) identifying~     CYP3A4 * 22 and CYP3A5 * 3 polymorphisms and hematocrit as explanatory variables of the~     observed variability in pre-dose (Co) concentrations. According to this model, the proportion~     of patients that do not reach the therapeutic target is 40~   "
7750|NCT03465397|"~     This is a clinical trial comparing the immunosuppressive treatment determined according to~     two biomarkers, donor-specific IFN-γ ELISPOT and Mismatch of HLA between donor and recipient,~     in patients undergoing low immunological risk live donor kidney transplantation~   "
7751|NCT03465384|"~     The Comet-program is a Swedish parent training program developed to target externalizing~     behaviors in children between 3-11 years. The program is normally delivered in group format~     in primary and specialized care and has already been evaluated in several studies. The~     internet-based version of the program has also been evaluated separately, but in this study~     the two formats will be directly compared in a randomized non-inferiority study. Parent~     ratings, child ratings as well as blinded clinical assessments will be conducted before the~     interventions, after the interventions (2-3 month after start of intervention), and at~     follow-up (12 mont after first assessment). The primary research question is: Will the~     internet-based format of Comet be at least as effective as the group format in reducing~     externalizing behaviors? Secondary research questions concern possible differential effects~     of the two formats on cost-effectiveness, parenting behaviors, parent mental health,~     applicability and consumer satisfaction, and the children's quality of life.~   "
8327|NCT03457857|"~     This study is to assess the impact of two skincare regimens on the cutaneous microbiome and~     skin physiology of healthy male and female infants, ages 3-6 months using clinical,~     instrumental, D-Squame tape, microbiome and parental assessments over a five-week period.~   "
7752|NCT03465371|"~     In response to the growing need for training on interventions to address first episode~     psychosis, the Center for Social Innovation (C4) has partnered with experts in Coordinated~     Specialty Care (CSC) to develop and test CSC OnDemand: An Innovative Online Learning Platform~     for Implementing Coordinated Specialty Care. The product builds on the findings of the~     Recovery After an Initial Schizophrenia Episode (RAISE) studies, funded by the National~     Institute of Mental Health (NIMH). RAISE examined team-based models of care for people early~     in the course of schizophrenia. Through a Fast Track Small Business Innovation Research~     (SBIR) grant, investigators will prototype, test, refine, and evaluate the impact of CSC~     OnDemand.~   "
7753|NCT03465358|"~     Motor Function Measure (MFM) is a validated tool assessing the motor function of~     neuromuscular patients constituted of 32 items. Despite standardized Motor Function Measure~     (MFM) training sessions, there is still an inter-individual variability in the items' scoring~     procedure, depending for example on the subjectivity of the therapist.~      Among the 32 items of the MFM, 3 currently require the use of a paper, and could be automated~     by using a digital tablet. It is the item 18 where the patient traces the edge of a Compact~     Disc, item 19 requiring to draw loops inside a frame and item 22 requiring to place a finger~     on each standardized cases. The reproducibility of these 3 items could be improved with the~     use of a digital tablet and the development of a software allowing to computerize the scoring~     procedure. The second interest is to implement directly the MFM data in the MFM base.~      The hypothesis is that the difference of scoring of these 3 items between digital tablet~     versus paper completion is enough low to use indifferently each completion in patients with a~     neuromuscular disease.~   "
7754|NCT03465345|"~     The overall goal of this study is to identify a safe dose of metformin, in combination with~     oligomeric procyanidin complex (OPC) for pharmacologic reduction of AGE levels in patients~     with prostate cancer.~   "
7755|NCT03465332|"~     This study will evaluate the diagnostic measures (including blood eosinophil counts) commonly~     used by lung specialist's in routine clinical care of subjects with COPD in Germany and how~     these diagnostic tests influence the physician's treatment decisions. The study will be~     conducted in three parts. In the first part, lung specialist's, who will not participate in~     the survey, will develop doctor's questionnaire. The second part is an interventional~     cross-sectional study, wherein approximately 30 lung specialists will be enrolled and data on~     their perspective on diagnosis and treatment of COPD subjects will be collected via the~     revised doctor's questionnaire. The third part is a retrospective non-interventional study~     where each doctor will collect retrospective data from selected subjects with COPD from the~     time of informed consent up to 12 months before. The retrospective data will be collected~     from subject files of approximately 250 subjects with COPD.~   "
7756|NCT03465319|"~     The anesthesia machine Draeger Perseus A 500 has an integrated software which calculates~     the predicted course of the concentration of oxygen and the volatile anesthetics sevoflurane~     and desflurane for the next 20 minutes.~      The Goal of this study was to evaluate the accuracy of this prediction under controlled~     clinical circumstances.~      Therefore 20 patients undergoing an operation with general anesthesia were included. They~     were assigned to a sevoflurane- or desflurane-group by lots.~      The oxygen- and volatile anesthetic influx into the anesthesia machine`s circuit was adjusted~     following a fixed protocol. The concentration of oxygen and the volatile anesthetic was~     measured and compared to the predicted values.~   "
7757|NCT03465306|"~     The aim of the present study is to develop and validate the effects of a new cognitive~     behavioral therapy (CBT) using digital healthcare mobile apps such as Noom Coach and InBody.~   "
7758|NCT03465293|"~     The mechanical bowel preparation (BP) used to clean the colon prior to colonoscopy frequently~     results in a significant but temporary reduction in patient's symptoms for a number of bowel~     disorders including symptomatic uncomplicated diverticular disease. The cause of this~     improvement is unknown.~      We hypothesise that changes to the gut microbial population (microbiota) are responsible for~     this improvement and that the repopulation of the GI tract with bacteria following~     colonoscopy results in a return of their normal symptoms. This pilot study will test this in~     a preliminary way by examining the stool, urine and blood of patients before and after bowel~     preparation to detect any destabilising effect that BP has on the gut microbiota and to what~     extent the microbiota repopulates at 3 months If the hypothesis is proven, this study will~     show that BP generates a 'window of opportunity' in which to influence the subsequent~     re-establishment of the microbiota. This is with the eventual aim of correcting potential~     dysbiosis and preventing the progression of symptomatic uncomplicated diverticular disease~     (SUDD).~   "
7759|NCT03465280|"~     Recurrent Respiratory Papillomatosis (RRP) causes wart-like growths in the airway which can~     make it difficult to breathe, speak and carry out normal everyday activities. It is a rare~     condition but is more common and aggressive in children than in adults, affecting 4 in every~     100,000 children. There is no known cure for RRP, but symptoms are checked through regular~     hospital visits, with multiple therapies or procedures under general anaesthetic needed to~     remove or shrink the growths which can grow back quickly. The problem is that nobody knows~     which therapies or procedures work best. Aim: To identify which RRP treatments currently used~     in National Health Service (NHS) hospitals within the United Kingdom (UK) are the most~     effective and safest in the short- and long-term. It will also identify which patients~     respond best to specific treatments, and those who are at higher risk of experiencing a~     complication after treatment. Method: Collect information from usual patient care and quality~     of life questionnaire responses in a secure online database. Participation in this study~     requires patient/parent/guardian consent. This observational study does not require patients~     to undergo any additional intervention as part of the research.~   "
7760|NCT03465267|"~     Comparison of two types of robot (Armeo power vs Armeo spring) for upper extremity~     rehabilitation on upper extremity function~   "
7761|NCT03465254|"~     This is an observational study for 5 years, and aims to determine the risk of developing~     dengue among Philippine children who are eligible to receive the dengue vaccine during the~     DOH mass dengue vaccination, by dengue serostatus at baseline.~   "
8205|NCT03459443|"~     The primary purpose of this open-label, Phase 2 proof of concept study is to evaluate the~     efficacy of 12 months of oral ACH-0144471 in participants with C3G or IC-MPGN based on renal~     biopsy results and the number and percentage of participants with an improvement relative to~     baseline in clinical manifestation(s) of C3G (proteinuria and reduced estimated glomerular~     filtration rate [eGFR]).~   "
7762|NCT03465241|"~     The second generation of high-throughput gene sequencing (NGS) is an important means of~     detecting the tumor DNA and circulating tumor DNA (ctDNA), which can detect trace ctDNA from~     smaller plasma samples. This project is chiefly to study the role of ctDNA dynamic monitoring~     of stage IIA to IIIA NSCLC by NGS technique to verify the prognostic predictive effect of~     ctDNA. And the investigators also wander the concordance of lung cancer related genes~     mutation map and frequency between primary tumors and infiltrated regional lymph nodes.~   "
7763|NCT03465228|"~     Physical exercises proves to be an option to revert a vicious cycle and aggravation of the~     painful that chronic low back pain can provide, which can improve the mobility and~     stabilization of the spine, muscle strength, motor coordination and general aerobic~     conditioning. In addition, photobiomodulation using light emitting diodes (LEDs) has~     attracted attention for acute and chronic pain and wound healing, being used as a resource~     for prevention and recovery of lesions. Thus, the present study aims to analyze the efficacy~     of aerobic training systematized with Deep Water Running associated with photobiomodulation~     in individuals with chronic nonspecific low back pain. Individuals of both sexes, sedentary,~     who present chronic low back pain, aged between 30 and 55 years (middle-aged individuals) who~     meet the inclusion and exclusion criteria will be invited to participate. Anthropometric~     measurements, maximal stress test, functional tests, physiological measures and~     questionnaires concerning disability and pain, besides psychological ones, will be carried~     out. After the evaluations, the participants will be randomized into three experimental~     groups with 15 participants in each: the first group will be the training group that will~     hold interval training sessions in addition to continuous training sessions (GT). The second~     group will perform the same training model, and before the training sessions the LED will be~     applied (GTL). And the third group will only receive the LED application (GL).~   "
7764|NCT03465215|"~     Crohn's Disease (CD) patients, belonging to Inflammatory Bowel Disease (IBD), frequently~     suffer from uncontrolled intestinal inflammation. This can lead to severe disease~     complications requiring hospitalization. Up to 50% of all CD patients develope intestinal~     strictures. Intestinal strictures can be subdivided into predominantly inflammatory and~     predominantly fibrotic types. This subclassification in different types of strictures is~     important for clinical decision making: patients with predominantly fibrotic strictures would~     undergo surgery or interventional endoscopic treatment and patients with predominantly~     inflammatory strictures would be treated anti-inflammatory. To determining the degree of~     fibrosis and inflammation in CD strictures remains difficult.~      Digital holographic microscopy (DHM) is a new imaging approach belonging to the group of~     quantitative phase imaging. DHM enables stain-free quantitative phase contrast imaging and~     provides the determination of an refractive index which directly correlated to tissue~     density.~      This study aims to evaluate DHM for assessing the degree of fibrosis and inflammation in~     surgical specimen from patients with stricturing CD. The investigators collect full thickness~     surgical resection specimen from 29 patients with symptomatic CD strictures. More detailed,~     the investigators collect full thickness surgical resection specimen out of stenotic and~     non-stenotic bowel segments from each patient. For primary purposes, the investigators~     analyze the obtained tissue using DHM and compare differences of the refractive index,~     determined by DHM, between stenotic and non-stenotic parts of the intestinal wall. For~     secondary purposes, the investigators will correlate the findings made by DHM with a detailed~     analysis by a histopathologist using a scoring system (Goldstandard) to determine the degree~     of fibrosis and inflammation in the samples.~   "
7765|NCT03465202|"~     This is a multi-centre prospective non-interventional study designed to evaluate the effects~     of patient age on the pharmacokinetics of capecitabine and its metabolites 5'DFCR, 5'DFUR,~     and 5-FU. In addition, the study will assess the correlation between the pharmacokinetic~     parameters calculated and cytidine deaminase, biomarkers of aging, clinical frailty,~     treatment outcome, and toxicity. To be enrolled, patients must have breast or colorectal~     cancer and be eligible to receive capecitabine monotherapy in accordance with its approved~     clinical usage in the UK. Treatment will be administered according to NICE guidelines as well~     as the clinical judgement of the prescribing physician. One hundred patients (50 breast~     cancer patients, 50 colorectal cancer patients) who are about to start treatment with~     capecitabine monotherapy will be recruited to the study and undergo study procedures within~     the first week of treatment.~   "
7766|NCT03465189|"~     The investigators aim to determine the feasibility of using the Medtronic LINQ device for~     epilepsy diagnosis, monitoring and management. The feasibility will be determined by~     comparing EEG signals from the LINQ system to the gold standard clinical recordings. If~     seizures can be identified using the LINQ device with the same level of accuracy as adjacent~     scalp EEG recording electrodes, then the LINQ will be deemed feasible.~   "
7767|NCT03465176|"~     This study evaluates the effects of an inhaled blend of essential oils on fatigue scores~     among women who have hypothyroidism. Half of the participants will receive an essential oil~     blend to inhale daily for two weeks while the other half will serve as controls and inhale a~     carrier oil.~   "
7768|NCT03465163|"~     The main purpose of this research project is to evaluate the safety and effectiveness of a~     surgically implanted device called the Medtronic Activa PC+S System in patients with~     medically refractory epilepsy (people who have seizures that are not completely controlled by~     medical therapy). The system sends small electrical pulses into a part of the brain called~     the thalamus to help control seizures. It sends this signal in regularly, regardless of if a~     seizure is occurring. A different version of this device is already approved for the~     treatment of epilepsy in Australia. This study aims to use the brain's responses to single~     pulse electrical stimulation to measure the level of seizure susceptibility. The~     investigators would like to show that this measure can be used to provide more effective deep~     brain stimulation therapies, to stop seizures.~   "
7769|NCT03465150|"~     With 24 million results associated with Google's searchon keywords severe acne, Pr Dreno's~     team understand better thatthis disease, which affects many French people, is a real concern~     of Public Health and not a forced evil of the adolescent period, which will eventually~     resolve itself. Acne does not affect the vital prognosis, but its psychosocial impact is~     major and should not be underestimated. Paradoxically, despite the high prevalence of acne,~     few quality epidemiological studies have been published. Physicians are often helpless when~     faced with patients' questions. They often need a lot of explanations, especially on the~     factors aggravating this dermatosis, which greatly affects their quality of life.~      This cohort, the first of its kind in France, will determine the predictive factors of~     therapeutic response, endogenous and environmental factors impacting on the severity of acne~     assess the quality of life and psychological impact of acne patients, determine the patient's~     course of care and the associated costs. Pr Dreno's team will also build up a bio collection~     (bacteriological samples).~   "
8255|NCT03458793|"~     The purpose of this study will be to examine the feasibility of a Physical Activity~     Intervention for Loneliness (PAIL) in community-dwelling older adults. The research is a~     feasibility study designed as a two-arm randomised controlled trial (RCT) with a wait-list~     control group (intervention will be offered at 12 weeks to control group).~   "
7770|NCT03465137|"~     Social anxiety disorder affects as many as 12% of Americans, resulting in significant~     distress and disability. Although exposure therapy is one of the best treatments available,~     as many as 25% of patients do not respond and we do not know why. Extinction learning is~     thought to be the mechanism of exposure therapy, and the neuroscience of extinction learning~     has advanced significantly since exposure therapy was developed; however, there has been~     little application towards improved clinical outcomes.~      This project aims to improve exposure therapy response for patients with social anxiety~     disorder by directly linking exposure therapy response to the neurobiology of extinction~     learning. It also aims to increase our scientific understanding of how brain circuits work to~     support extinction learning. To do this, 80 adults with social anxiety disorder will randomly~     be assigned to either receive exposure therapy right away, or to wait before therapy.~     Participants will all complete a functional magnetic resonance imaging scan to assess~     extinction learning before the therapy.~   "
7771|NCT03465124|"~     The investigational device is an approved femtosecond laser (FSL) device with an integrated~     imaging system to perform certain steps of the cataract procedure. The FSL will perform~     anterior capsulotomy and lens fragmentation in individuals suffering from age-related~     cataract with need of cataract surgery.~      Cataract surgery will be performed in subjects who have signed an informed consent form.~     Macula thickness will be measured with Spectralis OCT on screening date.~      Postoperative examinations will be implemented in accordance with the approved~     investigational plan on subjects and includes: visual acuity, slitlamp examination, retinal~     oct imaging and quantitative autofluorescence.~   "
7772|NCT03465111|"~     ATLAS study is a clinical trial to evaluate the potential role of subcutaneous~     adrenocorticotropic hormone (ACTH) gel, in the management of scleritis.~      Specifically, the ATLAS Study aims to evaluate the safety, tolerability and effect of 2~     different dose regimens of ACTH gel administered by subcutaneous (SC) injection in patients~     with scleritis, over a period of 12 months. The patients will be randomized (1:1) at their~     first visit to one of the two treatment arms: Twice-weekly or thrice-weekly SC administration~     of 80 Units of ACTH Gel. The effect of two dose regimens of subcutaneous ACTH gel in patients~     with scleritis will be monitored and evaluated.~      Patients enrolling to the study include those with non-infectious scleritis, which is an~     inflammatory disease affecting the sclera (white outer coating of the eye) and cause blurring~     of vision, redness, tearing and painful ocular inflammatory episodes in one or both eyes.~     Scleritis may results in vision threatening ocular complications (corneal ulceration,~     cataract, glaucoma, retinal detachment) and subsequent blindness, if left untreated.~     Treatment of scleritis is usually chronic and requires systemic therapy with non-steroidal~     anti-inflammatory drugs and corticosteroids, along with immunosuppression therapy. Due to its~     treatment resistance nature, scleritis remains a therapeutic challenge for many~     ophthalmologists.~      H.P. Acthar Gel (ACTH Gel) is a highly purified preparation of adrenocorticotropic hormone~     (ACTH) in a gel that is designed to provide extended release of the ACTH following injection.~     ACTH stimulates the adrenal cortex gland to secrete cortisol, corticosterone, and~     aldosterone. It is FDA approved treatment for flares or on a regular basis (maintenance) in~     people with systemic lupus erythematosus (lupus), infantile spasms in infants and children~     under 2 years of age, adults with acute relapses or flares of multiple sclerosis (MS),~     patients with kidney diseases, among other indications. ACTH Gel is also approved for a wide~     range of allergic and inflammatory diseases of the eye.~      Given the established role of inflammation in the pathogenesis of scleritis and the~     anti-inflammatory effects of ACTH Gel treatment by blocking various inflammatory pathways, a~     beneficial outcome could be anticipated from ACTH Gel in patients with scleritis.~   "
7773|NCT03465098|"~     Infectious endocarditis (IE) is a pathology where the mortality rate of between 20 and 25%,~     but a higher morbidity since 50% of the patients are treated by a valvular surgical~     procedure. The diagnosis of IE is often difficult and therefore too late. In 2015, the~     European Society of Cardiology recommendations published by the integrate Positron Emission~     Tomography with Computed Tomography (PET/CT) with 18F-Fluorodeoxyglucose (18F-FDG) in the~     diagnostic management of IE.~      However, during conventional examinations, with 12 hours fasting and low carb dieting,~     myocardial uptake of 18F-FDG may be intense and interfere with results.~      The purpose of this study is to assess a strict low carbohydrate diet as Atkins (<3gram/day~     of carbohydrate) diet to facilitate the infective endocarditis diagnosis by 18F-FDG PET/CT~     Primary objective is to assess a strict low carbohydrate diet during 12h and 12h fasting for~     enhancing the contrast between infect area and surrounding structures and improve the~     detectability of infective endocarditis by PET/CT~      Secondary objectives:~        1. Comparison of the detection sensitivity of IE outbreaks between 18F-FDG PET/CT performed~          with the low carbohydrate diet and conventional diet performed~        2. To assess the strict low carbohydrate diet effects on the uptake 18F-FDG distribution ,~          particularly in the myocardium, circulating blood, skeletal muscles, brain and liver.~        3. Characterization of metabolic changes generated by the low carbohydrate diet using~          plasma bioassays (blood glucose, insulinemia, free fatty acid concentration,~          ß-hydroxybutyrate).~   "
7774|NCT03465085|"~     Background: Intra-alveolar clotting and alveolar collapse in ARDS is due to alveolar~     capillaries epithelial and leakage. Subsequently, collapse induces hypoxemia that is~     resistant to recruitment (RM). Heparin and Streptokinase may prevent or dissolve~     intra-alveolar fibrin clot respectively helping alveolar re-expansion. We examined and~     compared the effect of nebulizing Heparin versus Streptokinase on reversing this pathology.~      Methods: Sixty severe ARDS (PaO2/FiO2<100) patients and failure of RM, prone position (PP)~     and neuromuscular block (NMB) were partially randomised into Group (I): (n=20) received~     nebulized Heparin 10000 IU/4h. Group (II): (n=20) received nebulized Streptokinase 250,000~     IU/4h. Group (III): (n=20) received conservative management. Randomization to either Heparin~     or Streptokinase groups was applied to patients whom guardian accepted participation, while~     those who declined participation were followed-up as a control. The primary outcome was the~     change in PaO2/FiO2; the secondary outcomes included the change in compliance, plateau~     pressure, ventilation-off days, coagulation and ICU mortality.~   "
7786|NCT03464929|"~     Several videolaryngoscopes have been developed but few have been compared in terms of their~     learning curves and efficacy. The aim of this study is to compare the learning curves of~     Airtraq versus King Vision in a group of residents trained in direct laryngoscopy. Four~     residents will perform, after a short training in manikin, 8 intubations with each device.~     The sequence of use of the devices will be randomized. Outcome measures will be duration of~     intubation attempt, glottic visualization and percentage of intubation success.~   "
7787|NCT03464916|"~     The study is an open-label Phase 1 single dose-escalation safety study of CAR2 Anti-CD38 A2~     CAR-T Cells in patients with Relapsed or Refractory Multiple Myeloma, who meet all other~     eligibility criteria.~   "
7788|NCT03464903|"~     The purpose of this study is to try to understand why reversals of amyotrophic lateral~     sclerosis (ALS) and primary muscular atrophy (PMA) take place. The study will enroll patients~     with ALS or PMA reversals to give saliva samples in order to determine if the ALS or PMA~     reversal is because of certain changes in the genetic code.~   "
7775|NCT03465072|"~     Heart failure with preserved ejection fraction (HFpEF) accounts for approximately half of the~     heart failure population in the United States. The primary chronic symptom in patients with~     HFpEF is severe exercise intolerance quantified as reduced peak oxygen uptake during whole~     body exercise (peak V̇O2). To date, studies have focused almost exclusively on central~     cardiac limitations of peak V̇O2 in HFpEF. However, in stark contrast to heart failure with~     reduced ejection fraction (HFrEF), drug therapies targeting central limitations have~     invariably failed to improve peak V̇O2, quality of life, or survival in HFpEF. Emerging~     evidence from our lab suggests reduced skeletal muscle oxidative capacity may contribute to~     exercise intolerance in HFpEF patients. However, the mechanisms responsible for peripheral~     metabolic inefficiency remain unclear. Reduced blood flow (oxygen delivery), and slowed~     oxygen uptake kinetics (O2 utilization) may both contribute to reduced peripheral oxidative~     capacity. Importantly, reduced oxidative capacity may result in increased production of~     metabolites known to activate muscle afferent nerves and stimulate reflex increases in muscle~     sympathetic (vasoconstrictor) nervous system activity (MSNA). However, to date there have~     been no studies specifically investigating the contribution of peripheral metabolic and~     neural impairments to reduced exercise capacity in HFpEF. The overall aim of this proposal~     will be 1) to identify impairments in peripheral vascular, metabolic, and sympathetic neural~     function and 2) to assess the ability of small muscle mass (knee extensor, KE) training,~     specifically targeting these peripheral skeletal muscle deficiencies, to improve aerobic~     capacity and exercise tolerance in HFpEF.~      GLOBAL HYPOTHESIS 1: HFpEF patients will demonstrate reduced skeletal muscle oxygen delivery,~     slowed oxygen uptake kinetics, and elevated resting and metaboreflex mediated MSNA.~      Hypothesis 1.1: The vasodilatory response to knee extensor exercise will be impaired in HFpEF~     patients.~      Specific Aim 1.1: To measure the immediate rapid onset vasodilatory response to muscle~     contraction, as well as the dynamic onset, and steady state vasodilatory responses to dynamic~     KE exercise.~      Hypothesis 1.2: Skeletal muscle oxygen uptake kinetics will be slowed in HFpEF.~      Specific Aim 1.2: To measure pulmonary oxygen uptake kinetics during isolated KE exercise in~     order to isolate peripheral impairments in metabolic function independent of any central~     impairment.~      Hypothesis 1.3: HFpEF patients will demonstrate elevated MSNA at rest, and exaggerated~     metaboreflex sensitivity during exercise.~      Specific Aim 1.3: To test this hypothesis the investigators will measure MSNA from the~     peroneal nerve at rest, and during post exercise ischemia to directly assess metaboreflex~     sensitivity in HFpEF.~      GLOBAL HYPOTHESIS 2: Isolating peripheral adaptations to exercise training using single KE~     exercise training will improve peripheral vascular, metabolic, and neural function and result~     in greater functional capacity in HFpEF.~      Hypothesis 2.1: Isolated KE exercise training will improve the vasodilatory response to~     exercise, speed oxygen uptake kinetics, and reduce MSNA at rest HFpEF.~      Specific Aim 2.1: The assessments of vascular, metabolic, and neural function proposed in~     hypothesis 1 will be repeated after completing 8 weeks of single KE exercise training.~      Hypothesis 2.2: Single KE exercise training will improve whole body exercise tolerance, peak~     V̇O2, and functional capacity in HFpEF.~      Specific Aim 2.2: To test this hypothesis the investigators will measure maximal single KE~     work rate, V̇O2 kinetics and peak V̇O2 during cycle exercise, as well as distance covered in~     the six minute walk test.~   "
7776|NCT03465059|"~     This study is designed to evaluate the safety and pharmacokinetics of zanubrutinib in~     subjects with impaired liver function in comparison with healthy subjects~   "
7777|NCT03465046|"~     This is a comparative study where two protocols of intensive therapies will be applied to~     study the improvements in the functional performance of the affected upper limb of children~     with hemiparesis and check whether to increase their quality of life.~   "
7778|NCT03465033|"~     Several studies describe that the maximum mandibular opening decreases 60% -70% immediately~     after orthognathic surgery (OS) and other variables, including laterotrusion, movement speed~     and facial mimic also decrease drastically. In addition, patients frequently experience~     temporary or permanent sensory orofacial disturbances ranging from 9% to 76% of cases.~      It has been described that scheduled early physiotherapy reduces these complications.~   "
7779|NCT03465020|"~     The objective of the study is to produce a dynamic picture of the adult ITP natural history~     and management in Italy by collecting standardized information retrospective and prospective~     data of patients in active management through a nation-wide registry.~   "
7780|NCT03465007|"~     Symptomatic hypotension during (or immediately following) hemodialysis complicates 5 to 30~     percent of all dialysis treatments and is associated with increased morbidity and mortality.~     Kidney Disease Outcomes Quality Initiative (KDOQI) and European Best Practice Guidelines~     define intradialytic hypotension as the presence of a decrease in systolic blood pressure ≥20~     mmHg or a decrease in mean arterial pressure by 10 mmHg, providing the decrease in blood~     pressure is associated with clinical events and need for nursing interventions. Common causes~     of intradialytic hypotension include excessive or rapid ultrafiltration, high blood flow~     during dialysis, CHF, taking the antihypertensive medications prior to HD, and others. One of~     the possible reasons that is surprisingly has not been approached worldwide for~     intra-dialytic hypotension could be more prevalent adrenal insufficiency in ESRD patients or~     a delay in the appropriate rise of endogenous serum cortisol given hemodialysis is considered~     by all means a stressful condition to the body. Investigators will assess first the~     prevalence of intradialytic hypotension at JUH dialysis unit. Investigators will screen~     patients who developed intradialytic hypotension for adrenal insufficiency by ordering random~     am cortisol. Then Investigators will give IV Hydrocortisone 100 mg prior to HD to patients~     who developed intra-dialytic hypotension and monitor their BP response during the HD~     treatments for 3 HD sessions (1 week, 3 HD sessions). After that, the same patients will~     receive 100 mg normal saline for 3 HD sessions. Both the administrator and the patient will~     be blinded for the interventions.~   "
7781|NCT03464994|"~     Presence/absence of subclinical keratoconus with corneal topographic abnormalities (skewed~     radial axes for forme fruste keratoconus, and inferior steepening for keratoconus suspect) on~     axial specular topography (TMS-4 Tomey), and elevation topographies: Pentacam (Oculus) and~     Orbscan (Bausch & Lomb).~   "
7782|NCT03464981|"~     The overall objective of this pilot analysis is to characterize the hemodynamic changes that~     occur during implantation of a left ventricular assist device (LVAD) in patients with~     advanced heart failure - specifically, how right ventricular function is compromised as a~     result of LVAD implantation.~   "
7783|NCT03464968|"~     In second line with advanced or recurrent biliary tract cancer refractory to first line~     gemcitabine plus cisplatin, efficacy of mFOLFOX vs. mFOLFIRI will be evaluated at randomized~     phase 2 trial.~   "
7784|NCT03464955|"~     Preprocedural, preoperative, and prevascular access anxiety in pediatric patients has been~     previously shown to increase the likelihood of family stressors, agitation, sleep~     disturbances, and negative behavioral changes. The purpose of this study is to determine if a~     non-invasive distracting device (Virtual Reality (VR) headset, Augmented Reality (AR)~     headset, or bed mounted Video Projection unit (i.e. BERT, Bedside EnterRtainment Theater)) is~     more effective than the standard of care (i.e., no technology based distraction) for~     preventing anxiety before non-invasive surgical sub-specialty procedures among children~     during out-patient clinic visits. Examples of the most common procedures include, but are not~     limited to gastrostomy tube exchanges, suture removals, dressing changes, foley insertions,~     EEG set up, chest tube removals, cast removals, pin removals and other similar procedures.~     (The investigators refer to these procedures under an umbrella term of non-invasive surgical~     subspecialty procedures). The anticipated primary outcome will be reduction of child's~     anxiety during and after procedures.~   "
7785|NCT03464942|"~     This is a multi-centre, open label, phase 2, randomised controlled trial of patients with~     advanced triple negative breast cancer (TNBC) who have received no more than one line of~     chemotherapy (not including neoadjuvant or adjuvant therapy) who will be randomised to be~     treated with SABR 20Gy in 1# followed by atezolizumab or SABR 24Gy in 3# followed by~     atezolizumab.~   "
7789|NCT03464890|"~     Open clinical study to evaluate the soothing and re-epithelizing activity of a single~     application of two cometic formulations (P926 - LICHTENA DermAD CREMA VISO and P927 -~     LICHTENA DermAD CREMA CORPO) on experimentally induced erythema by repeated tape stripping~     on the forearm (volar surface) of 20 healthy volunteers.~      Study products activity was assessed in comparison to placebo (P926P - LICHTENA DermAD CREMA~     VISO - PLACEBO) and versus untreated control area.~   "
7790|NCT03464877|"~     Low back pain (LBP) encompasses heterogeneous patients unlikely to respond to a unique~     treatment. Identifying sub-groups of low back pain may help to improve treatment outcomes.~     Our objective was to identify variables associated with a favorable outcome in soldiers with~     sub-acute and chronic LBP participating in a multi-station full-body supervised exercise~     program. The results obtained may permit generation of potential treatment effect modifiers~     that will eventually have to be validated before being recommended for clinical practice.~   "
7791|NCT03464864|"~     A Dose-Rising Clinical Trial to Evaluate the Pharmacokinetics, Safety and Tolerability of~     Treprostinil Inhalation Powder in Healthy Normal Volunteers~   "
7792|NCT03464851|"~     The purpose of this study is to determine the accuracy of a new non-invasive device, the~     Carotid Stenotic Scan (CSS), to check for stenosis of the internal carotid artery (ICA) as~     compared to a carotid ultrasound study.~   "
7793|NCT03464838|"~     Disordered gambling is associated to high impulsivity and excessive risk-taking behaviour.~     These behavioural characteristics related to addiction are linked to cognitive processes in~     specific brain areas located in the prefrontal cortex (PFC).~      With the aim of studying the role of PFC in disordered gambling, the investigators employ~     transcranial current direct stimulation (tDCS), a noninvasive brain stimulation technique~     that applies a very weak electrical current to the superficial areas of the brain.~      The clinical phase of the research consists on studying the effects of tDCS in combination~     with cognitive behavioural therapy (CBT) in patients that attend the United Kingdom (UK)~     National Problem Gambling Clinic. The main objective of the project is to investigate whether~     this technique can help to decrease impulsivity and risk-taking behaviour, and therefore~     offer improved opportunities for the treatment of disordered gambling.~   "
7794|NCT03464825|"~     Three months of balance training with follow-up 6 and 12 months thereafter.~   "
7795|NCT03464812|"~     The proposed study has been developed to evaluate patient, physician, and provider (educator)~     centered barriers to and facilitators for engaging in the Diabetes Self Management Education~     and Support (DSMES) and developing a patient-centered, physician supported DSMES program that~     could potentially address barriers shared by the patients and their healthcare professionals~     (Phase 1). The feasibility and efficacy of the newly developed program will be evaluated with~     an ethnically diverse cohort of 90 patients with type 2 diabetes (30 Caucasians, Asians, and~     Hispanics each) (Phase 2). A variety of outcomes including clinical, behavioral and~     psycho-social measures will be used to assess program acceptability and effectiveness.~   "
7796|NCT03464799|"~     Pathological specimens of 40 women that had been operated for endometriosis will be included~     in this study. These tissues will be stained with a marker named as PDL-1 in pathological~     examination. programmed cell death (PD-1) is expressed on T cells. The immunotherapies in~     which antibodies against these PD-1 and its ligands (PDL-1) have been used are accepted as~     very effective in the treatment of many cancers. If these ligands can be shown in the~     endometriosis, it will be an important step for the treatment of endometriosis.~   "
7797|NCT03464786|"~     This is a randomized, paralleled, control trial to validate the effectiveness and safety of~     Lando® absorbable collagen membrane for oral bone repair.~   "
7798|NCT03464773|"~     Children born with severe brain-based developmental disabilities frequently experience~     persistent unexplained periods of pain and irritability, often compounded by a limited~     capacity to communicate their distress. The investigators call this entity Pain and~     Irritability of Unknown Origin (PIUO). The investigators have designed a systematic approach,~     called the PIUO Pathway, to address the management of these children's pain and irritability~     with the goals of reducing pain symptoms, improving the day-to-day lives of the child and~     family, and simplifying treatment options for clinicians.~   "
7799|NCT03464760|"~     The investigators hypothesize that spirulina-silicon supplementation will lead to an~     improvement in vasomotor endothelial function, followed by decreased arterial wave velocity~     on the aorta and central arterial pressure compared to placebo subjects.~   "
7800|NCT03464747|"~     During shock, arterial hypotension, inadequate cardiac output and microcirculatory~     alterations lead to tissue hypoxia, multiple organ failure and death. Arterial lactate is~     considered as the best marker of tissue hypoxia. A lactate decrease during the first 6 hour~     is strongly associated with better outcome and may be used as a target for assessing the~     efficiency of shock resuscitation.~      The EIRUS system (Maquet Critical Care AB, 17154, Solna, Sweden) is a new device allowing the~     continuous measurement of venous lactate through a central venous catheter.~      However, before being used extensively, such device needs to be evaluated concerning its~     accuracy. The aim of the present study is to assess the reliability of this device.~   "
7801|NCT03464734|"~     This phase II, single-center study will assess the efficacy of pembrolizumab + nab-paclitaxel~     in patients who have metastatic urothelial tumor and do not respond to chemotherapy. The time~     between drug administration and progression of the disease will be assessed to determine if~     the drug will work.~   "
7802|NCT03464721|"~     This study represents the first step for testing this device in patients in real-life~     situations to evaluate the technological capacities and usability by the patient~   "
7803|NCT03464708|"~     This study aims to investigate the effect of beta-hydroxy-beta-methylbutyrate (HMB) on~     skeletal muscle wasting, physical function, strength and quality of life in survivors of~     critical illness. In addition, protein turnover, muscle biology and muscle histology will be~     investigated.~   "
7890|NCT03463577|"~     The purpose of this study is to assess the safety of Boostrix administered on or after the~     first day of the 27th week of pregnancy by conducting a post-marketing study that will~     provide safety information to the public and healthcare providers. This will be one of the~     largest cohorts of pregnant women vaccinated with Boostrix in the U.S. Through partnership~     between Kaiser Permanente Southern California (KPSC) and the sponsor, GlaxoSmithKline (GSK),~     information about the safety of maternal vaccination with Boostrix and maternal and infant~     adverse events in a community setting will be gained.~   "
7804|NCT03464695|"~     The aim of the study is to examine if automated oxygen delivery with O2matic is better than~     manually controlled oxygen therapy for patients admitted to hospital with an exacerbation in~     Chronic Obstructive Pulmonary Disease (COPD).~      O2matic is a closed -loop system based on continuous non-invasive measurement of pulse and~     oxygen-saturation that is processed in an algorithm that controls the flow of oxygen to the~     patient.~      The primary hypothesis is that O2matic increases time within acceptable oxygen-saturation~     interval and reduces time with hypoxia and hyperoxia. Secondary hypotheses are that O2matic~     improves patient's sense of safety compared to manual control, reduces nurse's workload,~     reduces admission time and reduces time spent with oxygen therapy.~   "
7805|NCT03464682|"~     To determine the efficacy of the HS-25 (10mg or 20mg) or in combination with Atorvastatin~     (10mg)in reducing low density lipoprotein-cholesterol (LDL-C) levels after a 12-week period~     of treatment in adults with primary hypercholesterolemia; To determine the safety of HS-25~     (10mg or 20mg) or in combination with Atorvastatin (10mg)in subjects with LDL-C after a~     40-week period of treament.~   "
7806|NCT03464669|"~     This project aims to evaluate the impacts of group prenatal education and online prenatal~     education on health determinants and users' health status.~   "
7807|NCT03464656|"~     The proposed research aims to study the effects of antioxidant therapy, commonly used in male~     infertility treatment, on semen analysis. Patients presenting with male infertility, who are~     found to have abnormal semen analysis shall be recruited to this study. They will be asked to~     provide a sample of semen for routine semen analysis and advanced semen tests including sperm~     DNA fragmentation and sORP before starting with antioxidant therapy and after 3-month~     treatment with antioxidants.~      After completing the data analysis, we intend to publish the study in high impact perr~     reviewed journals and present it in international conferences.~   "
7808|NCT03464643|"~     The aim of this study is to analyze whether there is difference in the effect of single~     embryo culture and group culture in PGD/PGS cycle, and provide reference for the feasibility~     of the clinical application of medium-based noninvasive PGD. This prospective study prepares~     for including 543 nomal fertilizated zygotes in each group over a 9-month period. For the~     recruited patients, all normal fertilizated zygotes were randomly allocated into two groups:~     cultured individually in 25 ul media or 2-3 embryos cultured together in 50 ul media. The~     blastocyst formation rates, aneuploid rates, clinical pregnancy rates, implantation rates and~     miscarriage rates will be compared between the two groups.~   "
7809|NCT03464630|"~     A mobile remote coaching program study to improve maternal mood and increase parenting~     practices that lead to better infant social-emotional and communication outcomes~   "
7810|NCT03464617|"~     Observational Study that evaluates the interest of Doppler waveforms classification in~     Peripheral Artery disease~   "
7811|NCT03464604|"~     The purpose of this study is to evaluate the process, accuracy and patient outcomes of~     pre-screening dermatology referrals in a clinical setting by a qualified nurse. The~     long-range goal of the proposed program is to improve referral wait times for patients to see~     a dermatologist for lesions suspicious for melanoma in comparison to normal standards of care~     in NS. If effective, this screening program would decrease wait times for those patients with~     lesions suspicious for melanoma providing earlier diagnosis and expedited treatment, and~     potentially reducing mortality rates.~   "
7812|NCT03464591|"~     The investigators intend to evaluate the function of left heart and right heart and the~     motion balance between four chambers of the heart by speckle tracking technique during the~     follow-up of patients with pulmonary hypertension, and explore the relationship between the~     balance and prognosis of patients.~   "
7813|NCT03464578|"~     Proximal humerus fractures are particularly frequent injuries and represent 6% of all~     fractures with an overall incidence of 63/100.000 in human. The goal is to assess our~     institutional evidence based algorithm for treatment of proximal humeral fractures.~      Objective(s):~        1. Test the algorithm in terms of clinical applicability and clinical outcome~        2. Compare general outcome and general complication/revision rate to the literature.~      Inclusion / Exclusion criteria: Inclusion: All patients with an acute proximal humeral~     fracture (not older than 48 hours) admitted to our institution later than 1.1.2014.~     Exclusion: Multilevel and pathological fractures are excluded.~      Terminally ill patients and those not being able, or willing to sing the informed consent.~      Project Centre(s): Single-centre.~      Statistical Considerations: Standard descriptive statistics will be performed using~     R-statistics program. Considering the population of 160 patients, we will be able to detect~     differences in proportions as low as 0.15 with power 82% and alpha = 0.05.~      Other methodological Considerations: Terms applicability of a treatment protocol and adhesion~     to protocol are not well defined for decision making in orthopaedic surgery.~   "
7814|NCT03464565|"~     The purpose of this study is to collect real-world performance and safety data on the~     Penumbra System including the 3D Revascularization Device in patients with acute ischemic~     stroke (AIS) due to blockages of the large blood vessels in the brain.~   "
7815|NCT03464552|"~     Women often experience pain and discomfort during colposcopic examination especially at time~     of colposcopic directed excisional biopsy, pre-procedure anxiety, women pain threshold may~     also increase pain, woman's cooperation during the procedure is affected by all these~     factors, which also may hinder the colposcopist from obtaining adequate data and biopsies.~      Several pharmacological and non-pharmacological methods have been studied to reduce pain~     associated colposcopic directed biopsy (CDB). We aim to study the effect of Celecoxib to~     reduce pain associated with CDB.~   "
7816|NCT03464539|"~     To test the activity of a polyglucosamine (PG) together with a Standard Management protocol~     (SM) on the occult and obscure gastrointestinal bleeding (OGIB) and the clinical symptoms in~     patients suffering from colonic diverticulitis (CD).~   "
7817|NCT03464526|"~     The purpose of this study is to determine the effectiveness of three doses of orvepitant,~     taken once a day, in the treatment of pruritus associated with atopic dermatitis.~   "
7911|NCT03463304|"~     The general objective of this project is to investigate the interplay of the gut microbiome -~     endocannabinoid axis with host environmental factors and intestinal, metabolic and mental~     health status in free-living adults with various metabolic statuses and lifestyles.~   "
8328|NCT03457844|"~     To assess the primary effects and safety of Anlotinib in patients with Gastroenteropancreatic~     Neuroendocrine Tumor G3.~   "
7818|NCT03464513|"~     Lower gastrointestinal bleeding occurs distal to the ligament of treitz and may involve the~     small bowel, colon and rectum .~      Active lower gastrointestinal bleeding is a common, potentially life threatening medical~     presentation that can be challenging to localize and treat .~      There are many diseases that may cause lower gastrointestinal bleeding, including~     angiodysplasia, diverticulosis, benign or malignant bowel neoplasm, inflammatory bowel~     disease, ischemic bowel disease, and infectious bowel disease.~      Often, gastrointestinal bleeding will stop spontaneously, but in approximately 25% of~     patients, bleeding is massive or recurrent, requiring imaging localization and directed~     therapy.~   "
7819|NCT03464500|"~     This is a Phase 2 randomized, double-blind, placebo-controlled study enrolling 90 healthy,~     overweight, middle aged subjects (30 placebo, 30 low dose and 30 high dose AMAZ-02~     intervention), 40-65 years of age, who are otherwise healthy. AMAZ-02, a food derived~     ingredient, will be given as a daily oral dose for 4 months.~   "
7820|NCT03464487|"~     Drug resistant epilepsy constitutes about one third of all children diagnosed with epilepsy.~     Although ketogenic diet is being used for drug resistant epilepsy for almost hundred years,~     its restrictiveness and adverse effects interferes with its compliance. So less restrictive~     alternatives like Low Glycemic Index Therapy diet is gradually becoming more popular and its~     effectiveness is well established. Still the restrictiveness of such monotonous diets is one~     of the most significant issues for long term maintenance of children on dietary therapy. In~     this study, we are planning to compare the efficacy of daily and intermittent Low Glycemic~     Index therapy Diet in children aged 1-15 years with drug resistant epilepsy in a open~     labelled randomized controlled non-inferiority trial. The children in intermittent LGIT arm~     will receive the dietary therapy for five days of each week, alternating with a liberal diet~     on the rest of the two days of the week.~   "
7821|NCT03464474|"~     Ulcerative colitis (UC) belongs to the group of inflammatory bowel disease (IBD) and is~     characterized by a chronic relapsing disease course. As uncontrolled intestinal inflammation~     can lead to severe disease complications, treatment of UC has evolved from sole treatment of~     symptoms up to histological remission which is marked by the absence of histological~     inflammation. To correctly assess and quantify the degree of histological inflammation in IBD~     patients remains difficult.~      Digital holographic microscopy (DHM) is a new imaging technique belonging to quantitative~     phase contrast imaging. It is based on the detection of optical path-length delays in a~     stain-free manner, thereby providing a refractive index which directly correlates to tissue~     density.~      This study aims to evaluate the role of DHM for quantifying the degree of histological~     inflammation in endoscopically acquired biopsies of UC patients in a prospective clinical~     trial. From 28 UC patients, the investigators will obtain endoscopically acquired colonic~     biopsies. The investigators will assess the degree of inflammation in these biopsies using~     DHM and in addition to this an experienced histopathologist will determine the degree of~     inflammation in these biopsies using a histological scoring system (Nancy-Score =~     goldstandard). Finally, the investigators will directly correlate the results from DHM~     analysis to the histological analysis using the Nancy-Score.~   "
7822|NCT03464461|"~     The optimal dose of ketorolac in the Emergency Department setting is no clear. We will~     compare 3 doses to determine the optimal dose.~   "
7823|NCT03464448|"~     This study is to address the mechanism of action of teriflunomide in a phase IV open label~     trial with Teriflunomide in multiple sclerosis. Researchers will recruit 20 relapsing~     remitting multiple sclerosis patients (Group 1) start on treatment with teriflunomide~     (Aubagio). Patients will be enrolled from the Multiple Sclerosis Center at the University of~     Michigan Health System in Ann Arbor. Meanwhile, 10 healthy controls will be recruited, to~     establish a healthy baseline for B and T cells, which are affected by both MS and its~     treatment (Group 2). This Study will collect baseline pre-treatment blood samples~     periodically for up to 2 years. Blood biomarker changes will be correlated with clinical~     response to teriflunomide treatment intervention.~   "
7824|NCT03464435|"~     To evaluate the efficacy and safety of 0.1% tacrolimus combined with loteprednol etabonate~     0.5%/tobramycin 0.3% (LE/T) in vernal keratoconjunctivitis (VKC) patients resistant to~     conventional treatment. This prospective 6-mouth period study aims to include 20 severe VKC~     patients who were not responding to conventional treatments. All the patients will be treated~     with 0.1% tacrolimus suspension two times daily, LE/T eye drops four times daily for 1 month.~     Additionally, 0.1% olopatadine two times daily and preservative-free artificial tears four~     times daily will be used. After the first month, LE/T will be stopped, with other treatments~     continued for the last 5 months. Visual acuity and intraocular pressure (IOP) will be~     measured at enrollment and 1, 2, 3 and 6 months after treatment. Besides, 6 subjective~     symptoms and 6 clinical signs will be graded at each visit based on a 4-point scale. The~     primary endpoints are the change in symptoms and objective signs. Treatment failure will be~     recorded if extra corticosteroids were required.~   "
7825|NCT03464422|"~     The purpose of this study is adapt an evidence-based intervention for stigma-related stress,~     mental health, and HIV risk for bay, bisexual, and other men who have sex with men (MSM) of~     color in small urban areas.~   "
7826|NCT03464409|"~     The goal of this study is to collect and describe patient and caregiver reported outcomes~     regarding surgical and non-surgical treatment for improving hand and arm function in the~     setting of cervical spinal cord injury. Eligible study participants will be recruited across~     the 4 sites and the investigators plan to recruit the following groups and numbers of~     participants:~        1. Nerve or tendon transfer recipients: people who have elected to undergo nerve (N=10) or~          tendon (N=10) transfer surgery to restore some hand and arm function as part of their~          standard clinical care and their caregiver (N=20)~        2. Non-surgical control group: people with cervical SCI (N=20) and their caregiver (N=20)~   "
7827|NCT03464396|"~     The purpose of this research study is to improve our understanding of unstable breathing and~     heart blood flow patterns seen in premature infants. The investigator will use novel~     non-invasive measures to understand the determinants of these unstable breathing and heart~     flow patterns to potentially identify new therapies for their prevention.~   "
7931|NCT03463044|"~     This was a single center, randomized, placebo-controlled study with a sequential i.v. dose~     escalation cohorts design, to assess safety, tolerability and pharmacokinetics of MOTREM~     (nangibotide) in healthy volunteers~   "
7828|NCT03464383|"~     As a potential solution to address high rates of depression and anxiety seen in epilepsy~     patients and poor mental health care access, this randomized trial aims to study treatment~     for anxiety and depression in epilepsy taking place directly within the epilepsy clinic vs.~     psychiatry referral (typical care). Patients that meet eligibility criteria, including~     significant symptoms of depression and/or anxiety, will be randomized to the either the~     intervention group or the control group. The intervention will consist of an initial~     prescription for an FDA-approved medication to treat depression/anxiety and telephone-based~     chronic care management plan for repeated symptom measurement and side effect surveillance.~     The control group will receive usual care, which is a referral order to psychiatry placed by~     their treating neurologist.~   "
7829|NCT03464370|"~     Recently, a possible subtype of temporal lobe epilepsy (TLE) has been proposed: this subtype~     presents ipsilateral amygdala enlargement (AE) without any other lesion. However, little is~     known about its clinical and psychiatric phenotype. The amygdala seems to play a major role~     in stress related disorders (including perception of stress). The hypothesis in this study is~     that patients with TLE-AE more frequently report emotional distress as a~     seizure-precipitating factor than any other epileptic patient.~   "
7830|NCT03464357|"~     Photophobia is a common and disabling symptom in patient with dry eye syndrome. The aim of~     this study is tried to better understand this complain analyzing brain activation during a~     luminous stimulation to highlight modification of cortical activation.~   "
7831|NCT03464344|"~     Cerebral amyloid angiopathy (CAA) is a major cause of lobar intracerebral hemorrhage (ICH) in~     the elderly with high risk of recurrence.~      The investigators aim to determine the relationship between cortical superficial siderosis~     (cSS), a MRI hemorrhagic marker of CAA and the risk of symptomatic ICH recurrence in a~     multicentric prospective cohort of patients with acute lobar ICH related to CAA. The~     investigators hypothesize that patients with cSS have an increased risk of recurrent~     symptomatic ICH relative to those without cSS.~   "
7832|NCT03464331|"~     Background Physical activity (PA), is an effective means of protecting against cardiovascular~     disease (CVD) development. PA refers to any skeletal muscle bodily movement that requires~     energy expenditure. Research shows that low- to moderate-intensity muscle endurance exercise,~     such as walking or brisk walking for about 15-20 minutes per day, is associated with a~     significantly lower CVD risk regardless of body mass index. Mobile technologies such as~     smartphone physical exercise apps offer a potentially cost-effective platform for~     facilitating regular exercise, allowing individuals to set goals, receiving feedback on~     achievements and health information for facilitating regular exercise. Zero-time Exercise~     (ZTE) is a new concept for physical activities (PA) and exercise promotion and can easily~     attract attention especially when most people believe that extra time is needed to do~     exercise. ZTE can be done easily during most time of day, while sitting, standing, walking or~     waiting. These include simple movements, such as stretching and resistance (endurance)~     movements of the head, neck and shoulders, chest and abdominal muscles and the upper and~     lower limbs. When ZTE is integrated into daily life and sustained with increasing intensity,~     the effects could be substantial, especially for those who are sedentary and have~     difficulties to meet the minimal requirements of 150 minutes of at least moderate PA per~     week. The term is also intended to motivate people to start with simple exercises (the~     'Foot-in-the-door' approach), change the mindset (that exercises need much time, money and~     sweats) and overcome the inertia from a sedentary lifestyle to become more active. It could~     also be a way to promote mental health (such as increasing happiness) through PA or exercises~     and enjoying the fun and satisfaction from the rapid improvements in fitness performances.~     Having brought some easily observable benefits quickly to those who are willing to try for a~     few days, ZTE might lead to more intensive or vigorous exercises requiring extra time for~     greater benefits.~      Objective:~      To test the feasibility [recruitment, dropout, and adherence to PA] of using whatsapp as an~     inertia reminder to promote the adherence of Zero-time Exercises (ZTE) in patients with CHD.~   "
7833|NCT03464318|"~     The aim of the study is to evaluate the intraobserver repeatability and the interobserver~     reproducibility of low-dose radiographs with a HELIOS DRF (CAT) imaging system in patients~     with idiopathic scoliosis.~   "
7834|NCT03464305|"~     The purpose of this study is to determine whether acetylsalicylic acidis effective on the~     recurrence and survival of colon cancer patients.~      Condition or disease: Colon Cancer (Adjuvant Therapy) Intervention: Drug: Acetylsalicylic~     acid; Drug: Placebo Acetylsalicylic acid Phase 3~   "
7835|NCT03464292|"~     Fibromyalgia (FM) patients have increased windup (WU). However, WU of FM patients is only~     quantitatively but not qualitatively different from healthy controls (HC). Thus WU~     abnormalities of FM patients could be the result of supra-spinal and not the result of spinal~     pain mechanisms. The study team will test this hypothesis by sensitizing FM patients with~     topical capsaicin. The study team hypothesize that at baseline the slopes of sensitivity~     adjusted WU of FM patients are not statistically different from HC. However, after capsaicin~     application, the slopes of sensitivity adjusted WU will be significantly different from~     baseline and greater than those of HC, suggesting central sensitization. This would imply~     that FM patients are sensitive to heat pain but not sensitized.~   "
7836|NCT03464279|"~     In an effort to implement Choosing Wisely guidelines and decrease patient harm, we will~     implement and evaluate a clinician audit-feedback and behavioral nudge initiative to reduce~     low-value antibiotics for URIs. Using a quasi-experiment (pre-post) design, antibiotic~     prescriptions for URI at LAC+USC Urgent Care Center (intervention site) vs. Olive View-UCLA~     Urgent Care Center (control site) will used to test the effects of behavioral nudge on~     antibiotic prescribing.~   "
7837|NCT03464266|"~     The primary objective of this study is to address critical safety questions with concurrent~     TDF-based PrEP and DMPA use. We hypothesize that young women using TDF-based PrEP and DMPA~     will have lower bone acquisition and altered bone metabolism. Bone mineral metabolism is in~     part regulated by the kidney, and we hypothesize that bone effects from concurrent PrEP and~     DMPA use will be driven by subclinical kidney injury, a known side effect of TDF, as well as~     DMPA-induced hypoestrogenism. To investigate our hypothesis, we will enroll a prospective~     cohort of approximately 500 HIV-uninfected women ages 16-25 years in Kampala, Uganda who have~     substantial HIV risk and are initiating DMPA or barrier method contraception. Over a 24-month~     period, we will offer TDF-based PrEP. We will use state-of-the-art radiologic, biochemical,~     and epidemiologic methods to test the hypothesis that concurrent TDF-based PrEP and DMPA use~     results in compounding adverse effects on bone health.~   "
7932|NCT03463031|"~     Study to evaluate the efficacy, safety and tolerability of GSP 301 nasal spray (NS) compared~     with placebo NS in pediatric subjects (aged 6 to under 12 years) with Seasonal Allergic~     Rhinitis (SAR).~   "
7933|NCT03463018|"~     This study evaluates whether Echinacea angustifolia (AnxioCalm) is a safe and effective~     treatment for mild to moderate Generalized Anxiety Disorder (GAD) symptoms. Half the~     participants will receive Echinacea angustifolia and half will receive placebo.~   "
7838|NCT03464253|"~     The parturients are at particular risk of post dural puncture headache (PDPH) because of~     their sex, young age, and the widespread application of spinal and epidural anesthesia. PDPH~     has a negative impact on quality of life, patient satisfaction, the postpartum experience~     with the mother's inability to bond with and care for her baby and it increases the economic~     burden associated with childbirth. Therefore, it is necessary to prevent or decrease its~     incidence and severity.~      TCD enables measurement of the blood flow velocity in intracranial arteries and its~     parameters are affected by both fluctuations in intracranial pressure and changes in cerebral~     vessel diameters. The possibility of equipment mobilization, the opportunity of repeated~     bedside technique together with the noninvasive nature, makes TCD measurements attractive in~     the attempt to estimate CBF and offers potential application to predict and follow patients~     with PDPH.~   "
7839|NCT03464240|"~     During dietary fat absorption, the gut packages the majority of the fats into lipid particles~     that are secreted into blood circulation. The gut is also capable of storing a considerable~     amount of fats that can be released at a later time upon receiving certain stimulus signals.~     One of the signals is glucose ingestion. This protocol examines how glucose ingestion~     releases gut lipid store. Participants drink a fatty formula and 5-9 hours later drink either~     a glucose solution or water (as control). One hour later, duodenal biopsy specimen are taken~     for analysis of lipid stores in the gut cells.~   "
7840|NCT03464227|"~     The purpose of the study is to evaluate the safety and tolerability of single ascending doses~     of UCB0107 administered by intravenous (iv) infusion in healthy male subjects.~   "
7841|NCT03464214|"~     In healthy individuals, many postural musculoskeletal problems arise due to various reasons.~     The cervical region is the region where these problems are most common. The cervical region~     ranks second in the general population after the lumbal area of musculoskeletal system~     disorders and affects close to 70% of the general population.The most important causes of~     this posture disorder are; muscular performance and strength are inadequate, as well as~     decreased proprioception of the muscles, deterioration of the individual balance systems that~     result in individual visual or vestibular problems.~      Exercise therapy is at the forefront of these methods, while a variety of methods are applied~     in the prevention and treatment of neck problems. Recent studies have focused on multifaceted~     treatments including exercises to improve strength, endurance and coordination of cervical~     muscles, proprioceptive training, relaxation exercises to prevent muscle tension,~     stabilization exercises and behavior modification. Cervical stabilization exercises are a~     frequently used exercise approach. Cervical stabilization exercises, which are different from~     ordinary exercises, are based on biomechanics, neurophysiology and physiotherapy research.~     The main objective of this method is; improve body awareness, maintain posture uniformity,~     improve strength, endurance, coordination and proprioception. Stabilization exercises also~     increase the strength and endurance of the postural and stabilizer muscles, improving~     stability control in the stabilized and non-stabilized positions.~      Another method that contributes to the development of balance and proprioceptive sense is~     vibration application. Proprioception plays an important role in ensuring the coordination of~     movements. When the proprioception input is disturbed, both the position sense and the speed~     of movement may be affected. Muscle-tendon vibration is a noninvasive method that is often~     used in proprioception studies. It has been suggested that the vibration application are the~     enhancing effect of the proprioceptive. However, there is not enough research on this~     subject.~      The purpose of this study is to determine whether the cervical stabilization exercises to be~     applied to the cervical region and the local vibration applied to the neck muscles are~     related to muscle performance, proprioception and balance and their superiority with each~     other.~   "
7842|NCT03464201|"~     The good tolerability profile of enzalutamide, the fact that the administration of steroids~     is not necessary and the impressive results achieved in prostate cancer, make this drug an~     ideal candidate to be tested in ovarian granulosa cancer, a tumor that could somehow be~     considered as female prostate cancer.~   "
7843|NCT03464188|"~     The burden placed on advanced cancer family caregivers (FCGs) and the toll on their mental~     and physical health have never been greater and is particularly pernicious for underserved~     groups in the Southeastern U.S., including rural-dwellers and African-Americans, for whom~     interventions have not been specifically developed and tested. The purpose of this K99/R00 is~     provide the awardee with the knowledge and training necessary to become a leading independent~     clinical investigator in developing and testing telehealth palliative care interventions for~     family caregivers (FCGs) of underserved persons with advanced cancer. The research specific~     aim during the K99 phase was to develop and tailor the content, format and delivery of a~     telehealth intervention for FCGs of persons with advanced cancer in the rural South. To meet~     this aim, qualitative semi-structured interviews were conducted with 26 lay healthcare~     navigators, 20 FCGs, and 18 patients with advanced cancer to elicit feedback on a FCG~     intervention outline based on published evidence-based interventions. After thematic~     analysis, major findings included that the intervention should: have topical content that is~     flexible and based on continuous assessment; include at least some face-to-face contact;~     cautiously consider internet-based technologies because internet access in rural areas is~     poor; and potentially have navigators lead the intervention with appropriate oversight and~     additional training. K99 study findings have been used to adapt and develop a potentially~     scalable FCG intervention in the Southern U.S. population (Project Cornerstone). The K99~     study phase in combination with accomplishing the training objectives has successfully~     catalyzed the awardee's transition from a Postdoctoral Fellow to a Tenure-Track Assistant~     Professor at the University of Alabama at Birmingham School of Nursing. The overall goal~     during the R00 phase will be to conduct a small-scale pilot RCT of Cornerstone with 60 FCGs~     of rural-dwelling and/or African-American patients with advanced cancer to assess~     acceptability, feasibility, and potential efficacy. The research specific aims during the R00~     phase are to: evaluate the acceptability of Cornerstone and the feasibility of enrolling and~     retaining 60 participants into a RCT of the FCG intervention for 24 weeks (Aim 1) and~     evaluate the potential efficacy of Cornerstone in improving caregiver (Aim 2) and care~     recipient (Aim 3) outcomes compared to usual care (quality of life and distress~     [anxiety/depressive symptoms]). The results will directly support an R-01 application to~     conduct an efficacy RCT of an early, telehealth PC intervention for Southern FCGs of~     underserved persons with advanced cancer.~   "
7844|NCT03464175|"~     The intention is to enroll a specific sample of intubated patients. To compare the effect of~     respiratory gas conditioning on lung deposition and considering the well-known influences of~     lung pathology on lung deposition, intubated patients with healthy lungs will be included.~     Postoperative neurosurgery ventilated patients respond perfectly to this criteria. A previous~     study including 17 postoperative neurosurgery patients was performed in 2013 with a perfect~     collaboration between the ICU and the Department of Neurosurgery and Anesthesiology.~   "
7845|NCT03464162|"~     Early intervention programs for psychosis help improve short-term treatment and recovery~     outcomes for individuals experiencing psychosis. OnTrackNY is a coordinated specialty care~     (CSC) program, developed to treat young adults within two years of experiencing a~     non-affective episode of psychosis. This project aims to expand the role of family engagement~     and support within the OnTrackNY model. Borrowing from the Needs Adapted and Open Dialogue~     models, the study team created a family therapy service that includes the client and members~     of his/her social network to navigate crises and assist in treatment planning. This service,~     Social Network Meetings, will be offered to individuals enrolled in the OnTrackNY@MHA program~     as an additional, voluntary, service option. The study proposes that the introduction of~     Social Network meetings may improve treatment and recovery outcomes.~   "
7952|NCT03462771|"~     Both aging and other factors associated with it may contribute to the development of~     sarcopenia, such as lack of physical activity, inadequate food intake, hormonal changes and~     age-related increases in cytokine levels. What is a growing number of elderly people in~     Brazil and the world, it is extremely important to conduct research in order to know the~     mechanisms of action of new strategies to combat sarcopenia. Supplementation with omega-3~     fatty acids is a promising intervention in sarcopenic rest. However, there is a practice of~     studies confirming the effects of omega-3 fatty acid supplementation on neuromuscular~     function in the elderly.~   "
7846|NCT03464149|"~     The main study aim is to quantify the agreement between the analytical results provided by~     two third generation and two second generation Parathyroid hormone (PTH) assays. The primary~     comparison will be performed between the second-generation PTH assayIntact PTH assay from~     Siemens Healthcare Diagnostics Inc. and the third-generation PTH assay biointact (1-84)~     from Roche Diagnostics in terms of a Bland-Altman analysis. Several studies have evaluated~     the correlation between various PTH assays at a single time-point, but no previous study has~     tested the hypothesis that longitudinal changes in PTH levels, which are important for making~     treatment decisions, can be monitored by several PTH assays alike. To this aim, the key~     secondary objective is to analyze the longitudinal variance in PTH over the course of 1 year,~     using each of two assays of the second and third generations, respectively. Other secondary~     objectives include determining changes in serum phosphate, serum calcium, fibroblast growth~     factor 23 (FGF23), with respect to treatment decisions. For clinical applicability of the~     results to be obtained here, an important goal of the present study will be not to influence~     treatment decisions, which will remain independent of the study investigators, at the full~     responsibility of the hemodialysis physicians.~      At every quarterly blood draw over the course of one year, the investigators will freeze the~     serum from 100 patients, and at the end of 4 quarters the investigators will analyze~     PTH-levels using the following assays: Intact Parathyroid Hormone (Advia Centaur, Siemens~     Healthcare), PTH-Intact (Cobas, Roche), PTH (1-84) - The agreement between the PTH assays~     will be analyzed at baseline, as well as at the subsequent quarterly evaluation time-points~     by Bland-Altman analysis and complemented by Passing-Bablok regression. The longitudinal~     changes in PTH will be displayed graphically and analyzed by estimating the within-patient~     variance across time, the between patient variance at each time-point as well as effects on~     the mean log-PTH level due to course of disease and therapeutic interventions from a linear~     mixed model.~   "
7847|NCT03464136|"~     The purpose of this study is to compare the efficacy of treatment with ustekinumab or~     adalimumab in biologic naive participants with moderately-to-severely active Crohn's disease~     (CD) who have previously failed or were intolerant to conventional therapy (corticosteroids~     and/or immunomodulators, such as azathioprine, 6-mercaptopurine, or methotrexate), as~     measured by clinical remission at one year.~   "
7848|NCT03464123|"~     The study is aimed to assess (a) the incidence of hyperoxia at the point of return of~     spontaneous circulation (ROSC) and (b) the role of arterial blood oxygen partial pressure to~     brain oxygenation during out-of-hospital cardiac arrest. 80 adult patients will be recruited~     in a physician staffed helicopter emergency medical services. Brain regional oxygen~     saturation and invasive blood pressure are monitored until hospital admission and arterial~     blood gases are analyzed immediately when the unit arrives to the patient and again at the~     time of ROSC.~   "
7849|NCT03464110|"~     The purpose of this study is to determine the effect of a clinician communication coaching~     intervention versus control on an objective measure of the quality of communication (primary~     outcome) and patients' perceptions of the quality of patient-centered care (secondary~     outcome), both overall and within Black and White patients.~   "
7850|NCT03464097|"~     This is a Phase 3, randomized, double-blind, placebo-controlled study to demonstrate the~     effect of oral ozanimod as maintenance therapy in subjects with moderately to severely active~     Crohn's Disease.~   "
7851|NCT03464084|"~     This project aims to test the impact of melatonin and MTNR1B variation on regulation glucose~     regulation in a highly controlled in-laboratory setting and ex vivo in pancreatic islets.~   "
7852|NCT03464071|"~     Due to the failure of the respiratory system, many patients admitted to the Intensive Care~     Units (ICUs) require the institution of invasive mechanical ventilation (MV), aiming at~     maintaining gas exchange, reversing respiratory muscle fatigue, among other benefits.~     However, an artificial airway installation may be harmful because of its deleterious capacity~     to the mucociliary clearance mechanism, predisposing to the accumulation of secretions and~     consequent respiratory infections. Physiotherapy in patients critical for the purpose of~     preventing and treating these respiratory complications. In this way, they are techniques~     that aim at a reexpansion and removal of airborne secretions. An application of manual~     hyperinflation with the Ambú (HM), applied through compression of the resuscitator (Ambu), an~     application of hypertension for the use of energy, pulmonary volume. Similar to the goal of~     manual hyperinflation, a hyperinflation maneuver without mechanical ventilator (HVM) is also~     widely used and has been shown to be effective. A maneuvering visa re-expansion of collapsed~     lung areas and increased peak expiratory flow, resulting in the mobilization of secretions.~     It is known that these techniques can cause deleterious effects to the lungs due to the high~     volumes administered and the variation in airway depression, predisposing to barotrauma and~     volutrauma, increasing the lung permeability and consequent pulmonary edema. There may also~     be a more subtle form of injury, such as a release of lung mediators, initiating a process of~     local inflammation. This biological response is called biotrauma, and if these mediators~     translocate into the systemic circulation, it can lead to dysfunction and death. The aim of~     the present study was to evaluate the biomarkers of pulmonary lesion in the hyperinflation~     maneuver with mechanical ventilator versus manual hyperinflation with environments in sudden~     patients under mechanical ventilation.~   "
7853|NCT03464058|"~     Part 1 of the study will be conducted to provide additional information on the safety and~     tolerability of single doses of BOS172767 in healthy participants, to evaluate the~     pharmacokinetic (PK) profiles (including relative bioavailability) of BOS172767 following~     oral administration of 3 prototype formulations in healthy participants compared to an~     immediate release capsule formulation (reference), and also to determine the relative~     bioavailability of a selected BOS172767 prototype formulation in the fed and fasted states.~      Part 2 of the study will be conducted to provide additional information on the safety and~     tolerability of escalating single doses of the selected formulation of BOS172767 in healthy~     participants, to evaluate the PK profile following increased single doses of the selected~     formulation of BOS172767 following administration in healthy participants, and also to~     evaluate the dose linearity of the selected prototype.~      Part 3 of the study will be conducted to provide additional information on the safety,~     tolerability, and PK of the selected formulation of BOS172767 following multiple ascending~     doses (MADs) over 14 days of dosing in healthy participants.~   "
7854|NCT03464045|"~     The aim of the study is to assess the risk of urinary tract malignancies in patients~     initiating empagliflozin (free or fixed dose combination) compared to patients initiating~     other sodium glucose co-transporter-2 (SGLT-2) inhibitors and to patients initiating a~     dipeptidyl peptidase-4 (DPP-4) inhibitor (2 separate comparison groups).~   "
7855|NCT03464032|"~     A Multicenter Open-Label Single-Arm Multi-Cohort Phase I Study of Pharmacokinetics, Safety,~     and Immunogenicity of BCD-135 (JSC BIOCAD, Russia) in Patients with Advanced Solid Tumors~   "
7856|NCT03464019|"~     The primary objective of this study is to determine whether etripamil nasal spray (NS) 70 mg~     is superior to placebo at terminating episodes of PSVT in an outpatient setting.~   "
7857|NCT03464006|"~     This study looks to examine whether an online patient tool to monitor factors affecting~     patients peripheral artery disease can lead to improvements in patients' disease and slow its~     progression.~   "
8178|NCT03459794|"~     We hypothesize that ivermectin, a drug used to treat parasitic worm infections, interacts~     with the human innate immune system and that this contributes to its anti-parasitic effects.~     Participants will donate blood before and after being administered the normal human dose of~     the drug. We will compare the cell types present in the blood and the chemicals known to~     influence the human immune system before and after the drug is given, as well as measuring~     any changes in gene expression in white blood cells 4 and 24hrs after the drug is taken.~   "
7858|NCT03463993|"~     Background Postpartum haemorrhage (PPH) is a major cause of maternal mortality worldwide~     accounting for 25% of maternal deaths. In Zimbabwe PPH is the second most common cause of~     death. Tranexamic acid (TXA) is widely used to reduce blood loss in elective surgery,~     bleeding trauma patients, and menorrhagia.~      The investigators seek to determine the efficacy of TXA in reducing PPH during and after~     elective caesarean section.~      Methods and Design The investigators intend to perform an open label randomized control study~     of 1,162 women who are undergoing elective caesarean section. The participants will be~     randomly selected to receive an intravenous infusion of TXA 10 minutes prior to skin incision~     or not to receive the intervention. Prophylactic oxytocin will be administered to all the~     women.~      The primary outcome will be incidence of PPH defined by blood loss equal to or more than~     1,000ml calculated by determining the difference in haematocrit values taken prior to and 48~     hours after caesarean section.~      Discussion In addition to prophylactic uterotonic administration, TXA is a complementary~     component acting on the haemostatic process that can be used in the third stage of labour to~     prevent PPH. It is a promising intervention that is cheap, easy to administer and would be~     easy to add to routine delivery protocols in hospitals. It would also help to conserve~     precious resources by reducing the need for blood products, and expensive surgical~     interventions to manage PPH.~      This large adequately powered randomized study seeks to determine the efficacy of TXA to~     validate its routine use at caesarean section to prevent PPH.~   "
7859|NCT03463980|"~     The purpose of this study is to conduct a pilot randomized controlled trial (RCT) with~     low-income, suicidal African American women and men that compares the relative effectiveness~     of compassion meditation (CM) versus a support group (SG) .~   "
7860|NCT03463967|"~     CONTROLLED TRIAL ON THE EFFECT OF TOMATO PRODUCTS IN OBESE CHILDREN WITH NON ALCOHOLIC FATTY~     LIVER DISEASE~      Aim of the study To evaluate the effect of the addition of a daily dose of lycopene enriched~     tomato sauce on the progress of NAFDL in obese children.~      Participants Children with obesity referred to the Hepatology unit of Dept.of Pediatric~     Clinic of the University Federico II of Naples. Diagnosis of NAFLD is made on the presence of~     fatty liver at ultrasound examination, with or without hypertransaminasemia.~      Patients are eligible on the basis of:~        -  Age 4-14 years~        -  BMI > 85°percentile~        -  Liver Steatosis evaluated as mild, moderate or severe by US (hyperechogenic liver tissue~          compared with the adjacent kidney cortex)~      Patients are excluded on the basis of:~        -  Liver disease~        -  Diabetes or manifest metabolic alterations~        -  Associated diseases Informed consent is obtained from the parents of the participating~          children. Sample size estimation To provide an 80% power to detect a 25% or greater~          relative shift of outcome variables, with a first degree error of .05 a sample of 50~          cases is estimated in a cross over trial.~      Study design This is a randomized, crossover, one side open trial with blinded outcome~     evaluation. A statistician who is not otherwise involved in the trial generated the~     randomized assignment sequence. At the enrollment all participants received a low carotenoids~     diet for two weeks (wash out), then children are assigned to the first intervention for 8~     weeks, and subsequently, in the crossover phase, they are switched to the second intervention~     for the next 8 weeks. No wash out is planned between the two treatments.~      Interventions~        1. Supplemented diet: 100 gr/day of Lycopene enriched tomato products (weekly average)~        2. Control diet: ordinary healthy diet, with no special encouragement to eat carotenes~          products All children are put on a 'mediterranean style' diet, with a controlled amount~          of calories: a dedicated dietitian for the whole study, irrespective of the treatment,~          checked their diet twice a week.~      At beginning (T0) and at the end of each treatment (T1 and T2) all patients underwent~     anthropomorphic measurements, including weight, height, waist, abdomen and hips~     circumferences. BMI and its standard deviation score are calculated.~      Regardless of group assignment, all participants are seen by a hepatologist at the end of~     each intervention and checked for liver steatosis, by US. Fasting blood samples are collected~     at beginning (T0) and at the end of each treatment (T1 and T2) to evaluate IR (assessed by~     HOMA), transaminases levels, lipids profile, oxidative state (assessed by antioxidant enzymes~     activity, serum levels of MDA and carbonylated proteins), inflammatory state (by cytokines~     serum levels, typing of lymphocytes subpopulations, metabolism of lymphocytes).~      Data collection are performed in a partially blind fashion: the statistician performing data~     analysis is blind to treatment.~      Outcomes: The primary outcome is reduction of the liver steatosis estimated by US Scan,~     according to the following parameters: parenchyma echogenicity (compared with that of the~     cortical of the right kidney), far gain attenuation, diaphragm blurring. steatosis.~      Secondary outcomes is reduction in Insulin resistance, Oxidative state, Inflammatory state.~      Statistical Analysis Data are inspected for normality and paired t-test (before/after) of~     each phase of the trial are performed when appropriate. The Median % change of each variable~     between the values at Time 8 and 16 weeks and values at enrollment are also looked. Ordinal~     logistic regression analysis, hierarchical, mixed model with adjustment variables are adopted~     to estimate the size of the effect.~      The study is approved by the Ethical Committee of University Federico II of Naples.~   "
7861|NCT03463954|"~     Prior to this confirmatory pivotal study, the multicenter Br-002 feasibility study was~     completed. 98% of tumors less than or equal to 15mm were completely ablated in one~     procedure.This study will evaluate Novilase for the focal destruction of malignant tumors of~     the breast that are less than or equal to 15 mm against a performance goal for the standard~     of care, lumpectomy. The ASBrS' goal of less than 20% retreatment by 2020 was selected as a~     representative performance goal, i.e., 80.0%, and is consistent with published effectiveness~     rates for lumpectomy.~   "
7862|NCT03463941|"~     The purpose of this study is to explore how working with a partner can influence~     participation in a church wellness program. There are many different types of church wellness~     programs. Church members are more likely to participate and achieve goals in these programs~     when they have peer support. The researcher would like to know what African American men and~     women think about working with a support partner. This information will help researchers~     design better church wellness programs. The participants are being asked to take part in this~     research because the investigators believe that it is helpful to share feelings and thoughts~     about experiences working with a partner to achieve health goals. This knowledge will be used~     to create church wellness programs that will help African American men and women prevent~     disease and live healthier lives.~   "
7863|NCT03463928|"~     Allogenic hematopoietic stem cell transplant (Allo-HSCT) is routinely used for treatment of~     aggressive hematological malignancies. The biological foundation of allo-HSCT is the~     graft-versus-leukemia (GVL) effect, which is primarily mediated by donor T cells present in~     the graft and is able to eradicate malignant B cells either CD19+ or CD19-. Relapse following~     an allo-HSCT remains a major challenge in the treatment of B-ALL. CD19-directed CAR-T cell~     therapy has shown promising results for the treatment of relapsed or refractory B-cell~     malignancies; however, a subset of patients relapse due to the loss of CD19 in tumor cells.~     Co-infusion of donor-derived CD19/22 bispecific CAR-T cells or CD19-directed CAR-T cells and~     donor-derived-HSCT has the potential to combine the CAR-T cell mediated targeted elimination~     of CD19 expressing B cells with GVL effect, which could have clear advantages in reducing the~     risk of relapse and the evolution of CD19− escape variants or clonally related malignancies~     in other lineages. Therefore, a complete and durable tumor responses induced by this~     immunotherapy could be expected.~   "
7864|NCT03463915|"~     Interstitial cystitis/bladder pain syndrome (IC/BPS) is a condition that results in long-term~     bladder and pelvic pain. IC/BPS affects women more often than men. How the disorder develops~     is not completely known, but one thought is that IC/BPS is closely related to other chronic~     pain conditions like irritable bowel syndrome and fibromyalgia. Although several options are~     available to treat IC/BPS, the therapy effects often don't last long. Studies in chronic pain~     disorders have shown that oral gabapentin is effective in relieving pain in these patients~     and some studies suggest that oral gabapentin also improves IC/BPS symptoms. The purpose of~     this study is to assess the effectiveness of oral gabapentin combined with bladder~     instillations to treat IC/BPS in women. The study hypothesis is that women with IC/BPS~     treated with bladder instillations and gabapentin will have improved outcomes compared to~     women treated with bladder instillations and placebo.~   "
7865|NCT03463902|"~     The majority of schizophrenia patients is impaired in hand gesture performance, which~     contributes to poor functional outcome and poor communication skills. The left inferior~     frontal gyrus (IFG) and the left inferior parietal lobe (IPL) are key nodes of the gesture~     network, which is less active in patients with schizophrenia. Here, the investigators test~     single 10 min sessions of tDCS known to either enhance or inhibit local brain activity for~     app. 1 hour. The investigators aim to determine, which protocol may improve gesture~     performance in patients and healthy controls. This is a randomized, double-blind, cross-over,~     placebo-controlled single-center trial in 20 patients with schizophrenia spectrum disorders~     and 20 healthy controls. Gesture performance will be tested immediately after each tDCS~     session, which are separated by 24 hours. Results of this study will inform larger~     interventional trials comparing 2 tDCS protocols with repeated administration.~   "
7866|NCT03463889|"~     This pilot clinical trial studies how well Gallium-68 prostate specific membrane antigen~     positron emission tomography (PET) work in diagnosing patients with thyroid cancer.~     Diagnostic procedures, such as 68Ga-PSMA PET, may more accurately diagnose thyroid cancer and~     find out how far the disease has spread.~   "
7867|NCT03463876|"~     The purpose of this study is to observe and preliminary explore the efficacy and safety of~     combination of Apatinib and SHR-1210 regimen in treating advanced hepatocellular carcinoma.~   "
7868|NCT03463863|"~     assessment of the safety and efficacy surgeon tailored rectus sheath midurethral sling~   "
7869|NCT03463850|"~     Osteoporosis is a common disease among elderly people, which leads to an increased bone~     fracture risk. Bone fractures can greatly reduce quality of life and increase age-related~     problems including reduced life expectancy. In clinical practice, a bone mineral density~     (BMD) scan using dual-energy X-ray absorptiometry (DEXA) is used for diagnosing osteoporosis.~     However, DEXA does not always accurately predict who will develop fractures and who will not.~     This is because bone mineral density alone does not capture all of the factors that~     contribute to bone strength. One factor bone mineral density does not measure is trabecular~     microarchitecture of bone (structure of bone).~      Our goal in this study is to use a specialized CT scan called Dual-Energy CT (DECT) to~     capture information about the trabecular (spongy) bone in the vertebra of the lower (lumbar)~     spine. Research has shown that this kind of information helps in predicting bone strength in~     bone specimens. The investigator will use this information to develop a method to more~     accurately predict which patients are likely to experience fractures of the lumbar vertebra.~     These are the most common type of fractures associated with osteoporosis.~      The participant is being asked to participate in this research study because a physician is~     treating the participant for osteoporosis and the participant has met the initial criteria to~     participate in the study. Participation in this study involves having a DECT scan, as well as~     a DEXA scan if the participant has not had one recently (within two months).~      Research studies include only those individuals who choose to take part. Please take time to~     make a decision. Please ask the study doctor or the study staff to explain any words or~     information that are not understood. The participant may also want to discuss it with family~     members, friends or other health care providers.~   "
7870|NCT03463837|"~     The JUUL 5% Electronic Nicotine Delivery System (ENDS) is being studied as an alternative to~     combustible cigarette use. This study aims to find out how much nicotine is in the blood and~     urine of healthy adult subjects after using three JUUL 5% ENDS compared to smoking usual~     brands of combustible cigarettes and stopping smoking.~   "
7871|NCT03463824|"~     This study will measure the effects of interactive, whole-body video games on movement~     behavior in people with chronic low back pain.~   "
7872|NCT03463811|"~     The present study is aimed to assess whether lactate determination in vaginal fluid is~     associated with and can predict onset of labor for women with suspected preterm prelabor~     rupture of membranes (PPROMs).~   "
7873|NCT03463798|"~     this study aim to evaluate wether new, non-invasive and non-contact devices such as~     Structured Light Plethysmography (SLP) and Sonar would be able to accurately detect and~     quantify diaphragm dysfunction (mono-or-bilateral) by assessing the asymmetric chest wall~     motion generated during spontaneous breathing as compared with a classic, standard and~     invasive technique.~   "
7874|NCT03463785|"~     Obstructive sleep apnea (OSA) is a sleep-related breathing disorder, often associated with a~     compromised upper airway space and an increase in upper airway collapsibility. The anatomical~     and functional abnormalities of the upper airway play an important role in the pathogenesis~     of OSA. It is hypothesized that there is racial variation in the craniofacial characteristics~     among OSA patients. However, inter-race comparisons based on previous studies can be~     problematic due to variation in measurements, OSA definitions and the sample size. Besides,~     to our best knowledge, there is no studies that made direct inter-race comparisons in the~     upper airway anatomy. Therefore, studies on inter-race comparisons of the upper airway~     characteristics are needed to further understand the role of race in the upper airway anatomy~     of the OSA patients. This would provide more insights into the pathophysiology of OSA, and~     could result in the development of new effective treatment strategies for OSA patients.~   "
7875|NCT03463772|"~     A single center, prospective, open-label, non-inferiority randomized controlled clinical~     trials (1:1 treatment ratio) regarding pregnancy outcomes between IVM and standard IVF among~     infertility couples with PCOS in China.~   "
7876|NCT03463759|"~     This study evaluates psychophysical measures of pain inhibition and facilitation, along with~     cortical responses to different sensory stimuli, in patients with recurrent low back pain and~     matched healthy individuals.~   "
7877|NCT03463746|"~     Background and Rationale:~      Every year, more than a 15 million people worldwide suffer a stroke1. Despite laborious~     rehabilitation programs 70% of those stroke patients still show limited gait ability after~     three months.~      Numerous RCTs have shown the superiority of over ground gait training and~     electromechanical-assisted gait devices in comparison with conventional over ground gait~     training alone. (Jan Mehrholz, Elsner, Werner, Kugler, & Pohl, 2013) However, most of these~     trials used the electromechanical-assisted gait devices in a very high frequency which is~     almost impossible to achieve in daily clinical routine. Therefore, the effect of a~     practice-oriented physical therapy protocol including electromechanical-assisted gait~     training remains unclear.~      Objective(s):~      The aim of this clinical trial is to investigate the effects of an integrated,~     practice-orientated individual physical therapy protocol with or without~     electromechanical-assisted gait training in subacute stroke patients, respectively.~      The effects of both physical therapy protocols will be compared with validated assessments~     covering the different components of the ICF framework: function, activity and participation.~      Primary objectives: Effects on gait ability and on basic activities of daily living (ADL).~      Secondary objectives: Effects on walking speed, walking capacity, functional mobility, muscle~     force, spasticity and reintegration to normal living (RNLI).~      Furthermore, different training-related data are recorded to capture the efficiency~     (intensity and hassle) of both physical therapy protocols.~   "
7889|NCT03463590|"~     Deep brain stimulation (DBS) offers an effective and safe treatment for patients with~     debilitating, otherwise treatment-refractory obsessive-compulsive disorder(OCD). Although~     several target areas for DBS have been used for OCD, such as the ventral capsule/ventral~     striatum and the subthalamic nucleus, not all patients show a clinical response, varying from~     10% to 61.5%. Exploring new DBS targets may be a key approach to improve this situation. The~     habenula is an evolutionarily conserved structure playing an important role in depression,~     punishment avoiding, reward, addiction, pain and circadian rhythms. The habenula can be~     considered a promising target for OCD treatment based on the following hypotheses and~     clinical observations.~        1. The lateral habenula DBS has significant clinical antidepressant effects.~        2. The habenula plays an important role in the regulation of dopamine and serotonin~          systems.~        3. Selective serotonin reuptake inhibitors, the first line treatment for OCD, are commonly~          used to treat clinical depression.~        4. The habenula serves as a 'negative reward center' that mediates or moderates stress,~          negative emotions and thoughts, aversive learning, and goal-directed behavior, which are~          core clinical symptoms and signs of OCD.~        5. In our hospital, DBS of the habenula produced a significant improvement in OCD symptoms~          in one patient who failed to respond to other treatments, including capsulotomy either~          alone or in combination combined with cingulumotomy.~      These theoretical and clinical considerations indicate that the habenula can be seen as a~     promising DBS target for OCD treatment. This study is focused on the effectiveness of~     bilateral DBS of the habenula for patients with treatment-refractory OCD. Furthermore, the~     study is aimed at exploring the influence of DBS of the habenula on brain activity and~     cognition.~   "
8348|NCT03457584|"~     Patients with intraretinal cystoid changes before scheduled membrane peeling for epiretinal~     membranes are included. Patients are randomized for balanced salt solution (BSS) or~     air-tamponade.~   "
31594|NCT03153527|"~     Investigator-initiated, placebo-controlled, multicenter noninferiority trial, comparing rapid~     termination of systemic glucocorticoid treatment with a tapering regime over 4 weeks.~   "
7878|NCT03463733|"~     Background~      Currently, no standard treatment exists for patients with recurrent glioblastoma multiforme~     (rGBM) and used 2nd line treatments have low (up to max. 20%) response rates and very modest~     response duration (months). The median overall survival for GBM patients is 12-14 months from~     the time of diagnosis; therefore the development of new therapeutic options is imperative. HU~     has been used to treat hematological diseases and solid tumors (such as melanoma, ovarian,~     squamous cell carcinoma, head and neck carcinoma and brain tumors) in combination with other~     anti-cancer agents, but never with TMZ. If found safe, HU+TMZ, is easily translated to the~     clinic.~      Purpose: Phase I trial to identify the maximum tolerated dose (MTD) for the combination of~     dose intense temozolomide (TMZ) and hydroxy-urea (HU) in (maximal) thirty patients with~     recurrent glioblastoma (rGBM).~      Plan of investigation:~      Month 0-24 (1st and 2nd year): Inclusion and follow-up of a maximum of 30 patients with rGBM~      Month 25-31 (3rd year): Follow-up of patients included in the trial, data analysis~     (determining MTD and explorative analysis) and manuscript preparation.~      Possible results:~        1. Obtaining MTD and safety profile of daily HU+TMZ in patients with rGBM;~        2. Preliminary data on the estimation of the median progression-free (PFS) and overall~          survival (OS), radiographic response proportion in patients with measurable disease, and~          exploratory correlation of treatment outcomes (PFS and OS) with~          o6-methylguanine-DNA-methyltransferase (MGMT) promoter methylation status in archival~          tumor specimens and further elucidation of underlying mechanism of re-sensitization of~          TMZ by HU. Exploratory analysis of biomarkers profile of platelets in patients treated~          with HU+TMZ.~   "
7879|NCT03463720|"~     Extremity wounds and fractures constitute the majority of war-associated traumatic injuries,~     both for civilians and combatants. War-associated injuries are often contaminated with~     foreign material, leading to infection. Wound infections is considered a major risk to life~     and restoration of function in war-wounded patients surviving past the first hours. In a~     cohort study the investigators aim to assess whether the infection itself affects patient~     outcome (i.e. amputation, death) when comparing patients with and patients without infection.~   "
7880|NCT03463707|"~     This study is to confirm efficacy and safety of study drug BP101 in female patients with with~     decrease or loss of sexual desire, which is equal to acquired generalized hypoactive sexual~     desire disorder (HSDD). Patients will be randomized in 1:1 ratio to either BP101 or placebo~     arms.~   "
7881|NCT03463694|"~     ELVIS Kids is a parallel, open label, randomised controlled trial (RCT) of Hypertonic Saline~     (HS) nose drops (~2.6% NaCl) vs. standard care in children <7 years of age with symptoms of~     an Upper Respiratory Tract Infection (URTI).~   "
7882|NCT03463681|"~     This is an open label single arm, multicenter, phase II study designet To assess the~     progression free survival (PFS) of cabozantinib in patients pretreated with one~     immunocheckpoint inhibitor (CPI) in monotherapy or in combination~   "
7883|NCT03463668|"~     To assess the efficacy of duodenal prostheses for duodenal stenosis established for~     endoscopic pyloric or duodenal stenosis on dysphagia~   "
7884|NCT03463655|"~     Current recommendations do not recommend the concomitant administration of albumin after~     ascites puncture in patients with ascites neoplasia unlike cirrhotic ascites. The etiology of~     ascites in cancer patients is multifactorial, particularly by hepatic invasion that can lead~     to ascites loaded with albumin. Ascites punctures therefore lead to undernutrition, recurrent~     early ascites by decreasing the oncotic pressure by hypo albuminemia and a state of anasarca~     affecting the quality of life.~   "
7885|NCT03463642|"~     To test the efficacy of different vitamin D delivery methods on serum 25(OH)D. Participants~     randomly assigned to one of seven groups - three placebo groups and 4 active supplement~     groups receiving 100,000IU vitamin D3~   "
7886|NCT03463629|"~     This study seeks to determine if a specialized multidisciplinary diabetes team (SMDT)~     approach that incorporates the use of the chronic care model can be an effective method for~     improving glycemic control in Hispanic adults with uncontrolled type 2 diabetes residing in~     the Rio Grande Valley. The study will expand the current model of care used and focus on the~     multidimensional aspects that consist of physical, nutritional, educational and psychological~     needs of this underserved Hispanic population residing in the Rio Grande Valley.~   "
7887|NCT03463616|"~     Rectal cancer is a common diagnosis. The prognosis after treatment has improved over the last~     decades, partly due to neoadjuvant radio(chemo)therapy, but also due to improved surgical~     technique (TME) and, in certain cases, due to adjuvant therapy after surgery. For some 15-20~     years, treatment of metastasis has changed; liver- and lung metastasis in certain situations~     are surgically removed, or in the liver, treated with ablation (radio-frequency). During the~     same period the possibilities for chemotherapy of metastatic disease have improved, with new~     drugs and more drug regimens.~      These changes in treatment pathways have required changes in how patients with newly~     diagnosed rectal cancer are worked up pre-treatment. Starting in the early 2000s magnetic~     resonance imaging of the pelvic area has developed and is today mandatory to be able to~     adequately stage the tumour and plan for the multi-modal treatment before and after surgery.~      In many hospitals the set-up is a combination of computed tomography of the abdomen and chest~     and to this a MRI of the pelvic organs is added, whereas others have adopted MRI also for the~     abdominal part, thus having an MRI of the liver for the diagnosis of liver metastasis~     initially, before surgery. For the chest organs, CT is still normative.~      MRI has a higher sensitivity and specificity to detect liver metastasis, compared with CT. In~     order to plan the liver surgery/ablations, most liver surgeons rely on MRI for detailed~     information about the position of the metastasis and the relation to large vessels.~      The aim of this study is to examine the possible differences in percentage of patients~     requiring further radiology examinations after basic set-up comparing the routine of initial~     MRI of abdomen (and pelvic organs) with the routine of initial CT of the abdomen (and MRI of~     the pelvic organs). Further included is an analysis of the rate of liver metastasis using the~     two different routines, and finally outcome over 12 months in terms of liver treatment for~     metastasis.~   "
7888|NCT03463603|"~     When doctors and nurses use accepted guidelines for quickly treating patients who come to the~     emergency department (ED) with a possible heart attack, patients do better. Research shows~     that there are racial-identity- and ethnicity-based differences in the symptoms these~     patients have, when and why they seek care, the treatments they receive, and how well they~     fare afterwards. There is also Canadian evidence that there may be racial-identity-based~     disparities in the care some patients receive, and it has been suggested that health~     professionals may unconsciously treat patients of different racial identities differently.~     But it is not known if there is racial-identity variation in the care given to Canadian~     patients with heart attack symptoms in the critical first hours after coming to an ED, or in~     their experiences of this care. The investigators collected information from the health~     records of patients who come to EDs with symptoms of heart attack. The investigators recorded~     events and times such as what provisional diagnosis was assigned to the patient, how often~     they received pain medication, how long until certain tests were performed and what~     treatments were offered. The investigators also collected information about things that might~     affect delivery of care, e.g., the number of doctors and nurses who were on duty.~     Participants also completed a short questionnaire about their reasons for coming to the~     hospital, how long they waited before coming and why, and what their experience in the ED was~     like. The investigators reviewed this information to see if there are racial-identity-based~     differences in the care received by patients with heart attack symptoms. The findings could~     identify important disparities, which could in turn inform future projects to correct these~     disparities, for example, education of health professionals about ethnic differences in ideas~     of health and illness.~   "
7891|NCT03463564|"~     The transition from the Pediatric clinic to the adult care is a challenging period for young~     adults with type 1 diabetes, due to the high risk of poor glycemic control. Achieving the~     glycemic target without hypoglycemia and/or large glucose excursions is of paramount~     importance for type 1 diabetic patients, who have high variability of daily glucose levels .~     Both insulin pump therapy and multiple daily injections of insulin are recommended strategy~     to achieve glycemic control in type 1 diabetes; however, no studies investigated the effects~     of insulin pump vs insulin injections on glycol-metabolic outcomes in the transition phase.~     The aim of this study was to evaluate the effects of continuous subcutaneous insulin infusion~     (CSII) therapy, as compared with multiple daily injections of insulin (MDI), on glycemic and~     metabolic control, in young type 1 diabetic patients transitioned to the adult diabetes care.~   "
7892|NCT03463551|"~     This study evaluates the safety and tolerability of 3 dose levels of ABL-101 and supplemental~     oxygen in acute stroke patients.~   "
7893|NCT03463538|"~     To compare the Oxford shoulder score at 6 months post intervention for primary frozen~     shoulder randomised to either an arthroscopic capsular release or hydro-dilatation~   "
7894|NCT03463525|"~     This is an open-label, single centre, Phase I study to determine the brain exposure of~     [11C]osimertinib in patients with EGFRm NSCLC with brain metastases.~   "
7895|NCT03463512|"~     Multicenter, open-label, controlled, randomized clinical study to evaluate the efficacy and~     safety of Racecadotril in infants, children and adolescents with acute diarrhea~   "
7896|NCT03463499|"~     The efficacy and safety of intravesical hyaluronic acid and chondroitin sulfate after~     transurethral resection of Hunner lesion in interstitial cystitis/bladder pain syndrome~     patients. To analyze the number and timing of recurrence based on a long-term follow-up.~   "
7897|NCT03463486|"~     Aim of this study is to give evidence to outpatient cardiac rehabilitation in Austria. The~     database created in this context is supposed to pave the way as instrument to document and~     comprehend quality of outpatient cardiac rehabilitation in Austria as a key for quality~     management. Analyses of the created database should be made on a regular basis.~   "
7898|NCT03463473|"~     This is a phase I study to determine the safety and toxicity, PK/PD, immunogenicity,~     biomarkers, anti-tumor activity and establish a preliminary recommended Phase 2 dose (RP2D)~     in subjects with advanced solid tumors.~   "
7899|NCT03463460|"~     This phase II trial studies how well pembrolizumab and sunitinib malate work in treating~     participants with thymic cancer that has spread to other places in the body or cannot be~     removed by surgery and does not respond to treatment. Monoclonal antibodies, such as~     pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Sunitinib~     malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Giving pembrolizumab and sunitinib malate may work better in treating thymic cancer.~   "
7900|NCT03463447|"~     This study has quantified the hand strength in movements of handgrip and pinch with~     electronic dynamometer.~   "
7901|NCT03463434|"~     Patients who have at least one stage 3 or 4 PI and are admitted to a participating treating~     facility will be candidates for study enrollment. Patients must provide written informed~     consent. Standard care for their admitted condition will be provided for the patients except~     for support surface selection, laboratory blood tests, PI measurement(s) by the 3-D camera~     measurement tool, and added pain and patient satisfaction assessments. Clinical assessments~     will be recorded weekly as described below. Patients will be followed until discharge from~     the LTACH or until 1) they require a different mattress for their admitted condition; or 2)~     reach a maximum of 12 weeks in the LTACH. At study discontinuation, a clinical general~     assessment of the quality of improvement of the PIs will be recorded.~   "
7902|NCT03463421|"~     The aims of this project are to:~        1. investigate the adherence and persistence to anticoagulation (and in specific, to VKAs~          and NOACs) in AF patients with previous ischemic stroke;~        2. identify predictors of poor adherence and persistence and~        3. assess whether the SAMe-TT2R2 score predicts adherence and persistence to~          anticoagulation~   "
7903|NCT03463408|"~     Immunotherapy + Radiation in Resectable Soft Tissue Sarcoma~   "
7904|NCT03463395|"~     Hypothesis:~        1. Tissue and salivary pepsin will resolve after 12 weeks use of Reza band, but not~          following standard of care alone.~        2. RFS, RSI and inflammatory cytokines (IL -1β, -6, and -8) will decrease to normative~          levels following 12 week use of Reza band, but not with standard of care alone.~   "
7905|NCT03463382|"~     Postoperative pain management in children is still standing as a problem to solve. Effect of~     quadratus lumborum block has been shown to be a promising technique to overcome postoperative~     pain in children undergoing low abdominal surgeries. Erector spinae plane block is a new~     defined relatively safer and easier regional anesthesia technique which could be used for~     this purpose. Primary aim of this double blinded randomized controlled trial is to compare~     the analgesic efficacy of this two block techniques in this group of pediatric patients.~   "
7906|NCT03463369|"~     The purpose of this study is to evaluate the safety, tolerability and reactogenicity of~     escalating doses of JNJ-64300535 delivered via electroporation-mediated intramuscular~     injection in nucleos(t)ide analogs (NA)-treated chronic hepatitis B (CHB) participants.~   "
7907|NCT03463356|"~     The current project will develop and test a brief 2-session shame intervention in individuals~     diagnosed with social anxiety disorder (SAD). Using a non-concurrent multiple baseline~     design, the investigators will determine whether the brief shame intervention leads to~     reductions in trait self-reported shame and state shame in response to an in vivo stressor~     task. The investigators will also evaluate the effect of changes in shame on trait SAD~     symptoms.~   "
7908|NCT03463343|"~     This study had the goal of analyse the neurophysiologic effects of both mechanical and manual~     cervical manipulation, in asymptomatic individuals.~   "
7909|NCT03463330|"~     The purpose of this study is to learn the effects of two mild body exercises on quality of~     life, non-motor symptoms, anxiety, depression, fatigue, sleep quality, cognition, and~     executive function on people with Parkinson's Disease (PD).~   "
7910|NCT03463317|"~     The study goal is to determine the clinical benefit of percutaneous catheter‐based left~     atrial appendage (LAA) closure in patients with non-valvular atrial fibrillation (NVAF) at~     high risk of stroke (CHA2DS2‐VASc Score ≥2) as well as high risk of bleeding as compared to~     best medical care (including a [non-vitamin K] oral anticoagulant [(N)OAC] when eligible).~   "
7912|NCT03463291|"~     Bone tumors are categorized according to their tissue of origin into cartilagenous,~     osteogenic, fibrogenic, fibrohistiocytic, haematopoietic, vascular, and lipogenic tumors.~      Magnetic resonance imaging (MRI) is now indispensable for the preoperative workup and~     therapeutic follow-up of patients with musculoskeletal tumors.~      The application of DW-MRI in bone marrow is today an established examination technique that~     provides a unique contrast and that can help in the detection of bone-marrow pathologies and~     the differentiation of benign and malignant bone-marrow lesions.~      Diffusion MRI provides quantitative and qualitative assessments of tissue cellularity and~     cell-membrane integrity. It is widely used for tumour detection, characterisation, and~     monitoring during treatment. Diffusion MRI supplies functional information that complements~     the structural evaluation.~      In combination with standard structural MRI parameters, the ADC value improves tumour~     characterization. Diffusion MRI can also be used to monitor tumours during chemotherapy.~     Tumour necrosis results in loss of cell membrane integrity and in expansion of the~     extracellular compartment, leading to greater water-molecule diffusion with an increase in~     the ADC value.~   "
7913|NCT03463278|"~     A prospective study of the blastulation rate in the outcome of the Freeze all strategy~   "
7914|NCT03463265|"~     A Phase 2, Open-label Study of ABI-009 (nab-Rapamycin) in Bevacizumab-Naïve Subjects with~     Progressive High Grade Glioma Following Prior Therapy and Subjects with Newly Diagnosed~     Glioblastoma. ABI-009 will be tested as single agent or in combination with standard~     therapies~   "
7915|NCT03463252|"~     Primary end points:~      This clinical trial is aimed to analyze the effectiveness of Levonorgestrel-Releasing~     Intrauterine System (LNG-IUS, Mirena®) in the fertility-sparing treatment of atypical~     endometrial hyperplasia and early endometrial carcinoma, including pathology response and~     pregnancy outcome.~      Second end points:~      To analyze the appearances of side-effects.~   "
7916|NCT03463239|"~     The primary objective of this clinical trial is to evaluate the safety of autologous~     engineered corpora cavernosa + albuginea constructs for treatment of complex penile~     deformities. Autologous endothelial and smooth muscle cells obtained from enrolled subjects'~     corpora cavernosa biopsy sample, will be culture expanded in vitro and used to seed~     decellularized corpora cavernosa + albuginea obtained from cadaveric-donors to create~     autologous bioengineered corpora cavernosa/albuginea constructs for repair of damaged penile~     tissues.~   "
7917|NCT03463226|"~     Heart failure (HF) has been associated with chronic deleterious effects on skeletal muscle,~     endocrine system, vasculature and sympathetic nervous system. These alterations have a~     significant impact on quality of life, leading to a reduction in functional capacity and~     limited symptoms, which involve dyspnea and fatigue. The investigators tested the hypothesis~     that hormonal anabolic deficiency associated with neurovascular alterations may worsen the~     prognosis of patients with heart failure.~   "
7918|NCT03463213|"~     While healthy lifestyle behaviors have been identified as instrumental to preventing chronic~     disease, programs to successfully promote healthy behavior adoption in underserved~     communities have had limited sustainable success. SHE Tribe is a culturally tailored, social~     network intervention created through CBPR to overcome previously identified barriers and~     improve health behavior among women in underserved communities.~   "
7919|NCT03463200|"~     This study aim evaluates the effect of Kinesio Taping (KT) on back muscle fatigue of low back~     pain patients, analysing the electromyography activity of longissimus muscle (median~     frequency) and the sustained time during a fatigue test (Ito test).~   "
7920|NCT03463187|"~     This is a multi-regional, randomized, double-blind, placebo-controlled, clinical trial to~     evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of SHR-1314 in adults~     with moderate-to-severe plaque psoriasis.~   "
7921|NCT03463174|"~     This is a randomized clinical trial designed to assess the 1-year effectiveness of two~     treatment modalities for the mandibular edentulists: conventional complete dentures and~     single-implant mandibular overdenture.~   "
7922|NCT03463161|"~     Study to determine response rate of the combination of pembrolizumab plus epacadostat in~     patients with head and neck cancers that have received prior immunotherapy.~   "
7923|NCT03463148|"~     Subjects will be measured with both a sensor and a reference device~   "
7924|NCT03463135|"~     Primary Objective:~      To assess tolerability and safety of SAR439794 [peanut extract (PE) sublingual immunotherapy~     (SLIT) adjuvanted with Glucopyranosyl Lipid A (GLA)] after repeated sublingual (SL) daily~     administration in peanut allergic adult and adolescent patients.~      Secondary Objective:~      To assess pharmacodynamics of SAR439794 after repeated SL daily administration in peanut~     allergic adult and adolescent patients.~   "
7925|NCT03463122|"~     Head-mounted display based virtual reality rehabilitation for hemispatial neglect.~   "
7926|NCT03463109|"~     Digital body charts are used to assess the pain experience in people with pain. People are~     asked to report their pain by shading a human body template on a digital tablet. The aim of~     this study is to investigate whether people with chronic low back pain, compared to healthy~     volunteers, consistently locate on a digital body chart all nociceptive stimuli induced in~     the lumbar region.~   "
7927|NCT03463096|"~     This is a study of advanced lung physiology in altered gravitational conditions, consisting~     of respiratory measurements in healthy volunteers during high G acceleration on a long-arm~     human centrifuge.~   "
7928|NCT03463083|"~     To determine if the epidural route provide an acceptable analgesia in spine surgeries and~     avoided the need for excessive IV analgesics. Also to determine whatever dexmedetomidine or~     fentanyl is more better neuroaxial adjuvant regarding providing early onset and prolonged~     analgesia and stable cardiorespiratory parameters~   "
7929|NCT03463070|"~     comparison of the effect of misoprostol before and after cesarean on the blood loss~   "
7930|NCT03463057|"~     The prognosis of Diffuse Large B cell Lymphoma (DLBCL) patients with an early relapse is~     dismal. Atezolizumab has shown promising activity in relapsed DLBCL patients. Toxicity data~     on atezolizumab are available for > 6000 patients and is manageable. The assumption of this~     study is that atezolizumab consolidation will result in higher disease free survival by~     eradicating minimal residual disease In melanoma and lung cancer consolidation immunotherapy~     after chemoradiotherapy has shown an increase in survival.~   "
48222|NCT02935725|"~     A Phase 1, Single-centre, Double-blind, Placebo controlled Crossover Study to Assess the~     pharmacoMRI Effects of AUT00206 in Healthy Male Participants~   "
7934|NCT03463005|"~     The present Pocock clinical trial study was conducted In the city of Mashhad in Iran between~     2015 and 2016. The study inclusion criteria were men with low fertility of sperm motility<25%~     and total motility <50% (asthenozoospermia), no history of endocrine diseases, no diabetes~     men, no hormonal problems in their wives, and a healthy salpingography in their wives. The~     study subjects were voluntarily assigned to royal gel and IUI groups. In royal gel group, 5~     grams of royal gel was used after menstruation and every other night before and after~     intercourse. IUI group received 75 units of FSH from the second day of the cycle. Then~     vaginal ultrasound was performed from the sixth day of menstrual cycle to determine the right~     size of follicle. 10000 units of HCG was administered when follicle diameter reached 16mm,~     and the study subject was prepared for IUI 32-36 hours later. Each subject alternately~     swapped groups following fertility failure.~   "
7935|NCT03462992|"~     In this prospective study, the main goal is to evaluate the strength of Monomark -a~     monocyte-based transcriptomic test combined to a mathematical model- in patients with a~     positive FIT test. Therefore, in parallel to the routine FIT screening, blood samples will be~     harvested and the monocyte genetic profile will be determined. This fundamental study, will~     disclose the diagnostic power of a biomarker panel (MonoMark) head to head with the~     well-established FIT diagnostic test, a core prerequisite for the routine use of this test as~     an alternative and more reliable CRC screening tool.~   "
7936|NCT03462979|"~     This study aims to investigate how knowledge of gluten immunogenic peptide (GIP) levels in~     stool and urine affects subsequent adherence to a gluten-free diet. Half of the participants~     will receive results in real-time using a home device and the other half will store samples~     to be tested at the end of the 30 week study. Participants will also have a diet review with~     a dietitian at the beginning of the end of their study and be asked questions about their~     symptoms, gluten-free diet adherence and quality of life.~   "
7937|NCT03462966|"~     Irritable bowel syndrome (IBS) is one of the most common gastrointestinal disorders, with a~     global prevalence of 11% according to a recent meta-analysis. The total cost of managing IBS~     in the United States is in excess of $30 billion per year, including indirect costs relating~     to loss of productivity of more than $20 billion. Abdominal pain/discomfort (i.e. visceral~     hypersensitivity) is present in all patients with IBS and remains the most therapy-resistant~     symptom. Apart from abdominal pain, which is measured subjectively using visual scales,~     several studies have shown a significant increase in rectal sensitivity, which is measured~     objectively using an inflatable balloon. Drugs which are shown to have objective effects on~     visceral hypersensitivity are crucial in the management of IBS.~      While certain drugs have shown to decrease abdominal pain, there is very little data to~     substantiate objective changes in visceral hypersensitivity. Rifaximin is a poorly absorbed~     antibiotic and the exact underlying mechanism of action for rifaximin in reducing the pain~     component of IBS remains unknown. However, rifaximin has been shown in randomized controlled~     trials to decrease abdominal discomfort in all subtypes of IBS.~      The investigators hypothesize that rifaximin is effective in decreasing rectal visceral~     hypersensitivity in IBS patients. In this study, the investigators propose to test this~     hypothesis by measuring visceral hypersensitivity using the graded balloon distention test,~     before and after a course of rifaximin. To test whether this effect is accompanied by~     treating SIBO, the investigators will also perform lactulose breath tests before and after~     rifaximin therapy.~   "
7938|NCT03462953|"~     The current study focuses on the localization and quantitative assessment of growth factors~     and cytokines related to the EMT process found in the human gingival tissue samples taken~     from periodontally diseased individuals compared to other samples taken from healthy~     individuals. Through this investigation the correlation between the severity of the disease~     and the amount of these factors will be studied aiming to alleviation of the high prevalence~     of periodontal diseases among the Egyptian population.~   "
7939|NCT03462940|"~     The pilot study is designed to investigate the acute and chronic effects of the diet~     supplement tauroursodeoxycholic acid (TUDCA) on endothelial function in participants with~     type 2 diabetes mellitus.~   "
7940|NCT03462927|"~     This is a phase 2, randomised, open-label, parallel-group, multicentre trial in which MC2-01~     cream and calcipotriene [CAL]/betamethasone [BDP] ointment (comparator) is investigated in~     subjects with clinically diagnosed extensive psoriasis vulgaris.~   "
7941|NCT03462914|"~     • Give an effective treatment for CPA-petroclival meningiomas and can detect the best~     approach for these tumors.~      . Improve the outcome of these patients and decease rate of recurrence.~   "
7942|NCT03462901|"~     Clavicular fracture, constitutes 2.6% e 5% of all adult fractures, most are located in the~     midshaft clavicle with different degrees of displacement. Conservative methods are commonly~     used for midshaft clavicular fractures treatment, but with various unsatisfactory~     complications such as nonunion, malunion and shoulders asymmetry. The rate of malunion after~     conservative treatment for the midshaft clavicular fractures reached 15%, and 30% patients~     were unsatisfied. Recently, early midshaft clavicular fractures could greatly reduce the~     incidence rate of nonunion and malunion. Open reduction and plate-screw ﬁxation was~     considered as the gold standard with the advantages of ﬁrm ﬁxation and earlier postoperative~     mobilization, but also with disadvantages of larger incision and more organizations being~     exposed, presenting with many postoperative complications. Intramedullary ﬁxation treatment~     for mid-clavicular fractures has been favored due to its strengths including small incision,~     less periosteal striping, dispersion of stress and simple to operate However, early~     intra-medullary implants, such as Hagie pins and Kirschner wires, have been gradually~     replaced due to insufficient stability. In addition, various nails such as elastic stable~     intramedullar~   "
7953|NCT03462758|"~     Intrauterine devices (IUDs) are historically placed at a six-week postpartum visit for women~     who desire intrauterine contraception after delivery. A two-week postpartum visit could be a~     convenient time for women to receive contraception, including IUDs. Offering women IUDs at~     two-weeks postpartum may decrease the risk of undesired pregnancy and rapid repeat pregnancy.~     This study will compare IUD insertion at two different times after delivery: two-weeks and~     six-weeks postpartum. This will allow researchers to assess whether the timing of IUD~     placement affects whether an IUD is expelled, or pushed out of it's ideal location.~   "
14333|NCT03379298|"~     This study is built upon the existing data in the Children's Health Study to examine the~     longitudinal association between childhood exposure to air pollutants and changes in diet~     among adolescents.~   "
7943|NCT03462888|"~     Rhabdomyosarcoma (RMS) stands for the most frequent soft tissue sarcoma in children and,~     adolescents and young adults (AYA, 15-25-year-old population), accounting for approximately~     half of the whole soft tissue sarcomas in these populations.. Conversely, RMS represents a~     very small proportion of the soft tissue sarcomas in adults (3%), that is less than 1% of all~     solid cancers of adults.~      To date, previous studies undertaken among the paediatric population have pointed out several~     prognostic factors such as tumor localisation, tumor invasiveness at diagnosis, tumor size,~     histological subset, and treatment plans. Age at diagnosis remains an independent prognostic~     factor.~      RMS management is consensual in Europe for paediatric population, essentially based on the~     protocol RMS 2005 within the framework of the European Paediatric Soft tissue sarcoma Study~     Group (EpSSG). Care in AYAs remain heterogeneous and are either achieved in paediatric~     department, according to EpSSG guidelines, or in oncology department, known as adult unit,~     depending on ESMO (European Society for Medical Oncology), which are non-specific~     recommendations for the management of rhabdomyosarcoma.~      No consensus has been published yet for RMS in AYA despite the growing interest in cancers in~     AYA population - topic.supported by the French National Cancer Institute (INCa) - and the~     increasing network between paediatricians and adult-oncologists. Thus management of RMS in~     AYA remains patchy/unequal depending on the type of care unit.~      Herein, with the support of the Oscar Lambret Center, we aim at assessing and identifying~     clinico-biological prognostic factors of rhabdomyosarcoma in AYA. Eventually, we hope to~     offer a standardized treatment to this population. Data collected from medical file will be~     anonymised in a confidential database of which the recipient is the sponsor of the study.~      The ancillary study will aim at characterizing the molecular profile of the~     difficult-to-classify RMS subtypes (fusiform or pleomorphic subsets) in molecular biology for~     ambiguous cases.~      From a scientific point of view, this study aims at understanding the parameters that may~     influence the prognosis of RMS in AYAs by evaluating various clinical and biological factors.~      Biologically, molecular profiling of RMS in AYA may improve the characterization of this~     tumour in this age group.~      At the clinical level, the completeness of the data collected will lead to a better~     description of RMS in AYAs. We hope to harmonize their therapeutic management by providing~     therapeutic adjustments according to population subsets.~      Finally, these results could also help to adapt the therapeutic management of AYAs within the~     framework of the European protocol that is currently under construction, and will involve~     both children and adults.~   "
7944|NCT03462875|"~     The incidence of inflammatory bowel diseases, (IBD) including Crohn's disease (CD) and~     ulcerative colitis (UC), is increasing in the developing world. Our recent Asia-Pacific~     population-based study in 8 Asian countries and Australia has demonstrated that Hong Kong and~     China have amongst the highest disease incidences in Asia while Australia has the equal~     highest incidence of these diseases in the world.~      The ENIGMA project comprises three main enteric microbiome domains of central importance to~     Crohn's disease. Two specific organisms which may play a critical role in disease~     pathogenesis, including the candidate protective bacterium, and the novel pathogenic~     candidate, will be characterised and studied in detail. Microbial findings will be related to~     detailed assessment of environmental factors that permit microbial changes or expression.~   "
7945|NCT03462862|"~     This study evaluate Candida Albicans growth on Bre-Flex versus PEEK denture base in Bilateral~     Maxillary bounded partial denture , half of patients will receive a framework with breflex~     denture base and the other half will receive a framework with PEEK denture base then evaluate~     the Candida growth~   "
7946|NCT03462849|"~     This study intended to assess the expiratory flow limitation (EFL) during tidal breath in~     patients intubated in intensive care unit (ICU) for moderate or severe acute respiratory~     distress syndrome (ARDS). EFL is defined as the lack of increase in expiratory flow in~     response to an increase in alveolar-to-atmospheric pressure gradient. It reflects airway~     closure. Early studies have been done using the Negative expiratory pressure (NEP) technique,~     which is no longer available. We proposed in present study a new method, which consists of~     diverting manually the expiratory flow to the atmosphere by-passing the expiratory valve. We~     aimed at assessing EFL at positive expiratory pressure (PEP) 5 cmH2O in semi-recumbent then~     in supine position together with measurement of trans-pulmonary pressure and regional lung~     ventilation. Higher PEP levels will be tested, namely 10, 15 and a trans-pulmonary PEP of 3~     cmH2O, in semi-recumbent position.~   "
7947|NCT03462836|"~     Traditionally, pain control methods based on narcotic analgesics have been used to control~     severe pain after surgery, but this has resulted in side effects such as vomiting,~     constipation, dizziness, mental confusion due to drugs, and respiratory depression. This~     slowed the recovery of the patient after surgery and increased the duration of~     hospitalization, which had a negative impact on the patient 's prognosis. In addition,~     research has been conducted on the use of various painkillers in a variety of ways over the~     past decade to reduce the dose of narcotic analgesics and to increase the effectiveness of~     pain control, since studies of anesthetics and narcotic analgesics have shown~     immunosuppressive effects.~      This study investigate the effect of multimodal analgesics for postoperative pain control on~     immune function amd prognosis in patients undergoing laparoscopic colorectal cancer~     resection.~   "
7948|NCT03462823|"~     Primary objective of the study is to evaluate efficacy of the surgical technique for ACL~     reconstruction using an osteoconductive scaffold, enlaced into the hamstring tendon~     autograft, compared to the traditional technique.~   "
7949|NCT03462810|"~     The goal of this compassionate use program is to provide a mechanism to supply Cabotegravir,~     CAB on an individual named patient basis for treatment of individuals who have no available~     treatment alternatives and/or limited treatment options (e.g., who are unable to participate~     in the Phase III clinical studies or do not qualify), and are in need of new drugs to~     construct an effective antiviral regimen and may require the use of parenterally administered~     drug given underlying medical conditions. You can access ViiV's Policy on Compassionate via~     https://us.viivhealthcare.com/media/124424/viivs-external-policy-on-cup_final-version_23feb20~     17.pdf.~   "
7950|NCT03462797|"~     The current project seeks to explore the use of emergent biosensor technology to detect~     opioid use. The investigators goal is to recruit 60 opioid naïve patients presenting at the~     College of Dentistry at UTHSC. Candidate participants must be scheduled for an upcoming~     dental procedure that will involve subsequent pain management using oral opioid medication.~     Participants will be consented prior to any study procedures. All participant information~     from this study will be kept strictly confidential (e.g., no individual data will be shared~     with the College of Dentistry).~   "
7951|NCT03462784|"~     Worldwide, there are more than 60,000 births annually of serious forms of thalassemia .The~     World Health Organization considers thalassemia to be a major health burden.~      Beta- thalassemia is a group of recessively inherited disorders of hemoglobin synthesis~     characterized by reduced synthesis of the ß-globin chain caused by a mutation. The homozygous~     state results in severe anemia which needs regular blood transfusion.~   "
7975|NCT03462459|"~     This study evaluates the efficacy of prophylaxis with oral vancomycin for preventing~     recurrent Clostridium difficile Infection (CDI) in patients who have experienced at least one~     CDI episode in the last 90 days and are receiving antibiotics for a non CDI condition.~     Participants will be randomized to receive either placebo or oral vancomycin in addition to~     their prescribed antibiotic therapy.~   "
7954|NCT03462745|"~     Background: The AccuVein AV300 device helps in venepuncture and intravenous (IV) cannulation.~     It uses infrared light that can be absorbed by the blood hemoglobin so that veins location is~     clearly viewed on the skin's surface.~      Objectives: To assess the effectiveness of the AV300 device over the standard technique in~     increasing the ﬁrst-time success rate (SR) for pediatric patients who needed IV cannulation.~      Methods: This was a prospective cross study of patients aged 0-18 years scheduled for surgery~     or examination under anesthesia but without having an existing IV access and after providing~     consent form. Patients were randomized into two groups; cannulation with AV300 or standard~     insertion performed by experienced pediatric anesthesiologists and residents under training.~   "
7955|NCT03462732|"~     The value of this study is to compare between stented endotracheal tube with nelaton catheter~     and non stented tube as regard nasotracheal related complications as epistaxis and nasal~     cavity injury.~   "
7956|NCT03462719|"~     The purpose of this study is to assess progression‑free survival (PFS) from treatment with~     ibrutinib plus venetoclax (I+VEN) compared with obinutuzumab plus chlorambucil (G-Clb) as~     assessed by an Independent Review Committee (IRC).~   "
7957|NCT03462706|"~     The study will compare the use of cold snare, hot snare, cold EMR, and hot EMR for polyp~     resection. Although previous studies have compared two of the potential resection methods, no~     previous study has evaluated all four of the resection methods.~   "
7958|NCT03462693|"~     A single-center, observational, prospective, two dynamic cohorts study with before-after~     design. Group 1: Treatment with 6 sessions using dry needling with DNHS® (Dry Needling for~     Hypertonicity and Spasticity) on the spastic muscles of the affected arm in patients with~     stroke plus standard physiotherapy treatment. Group 2: Standard physiotherapy treatment.~     Spasticity will be assessed by Modifying Modified Ashworth Scale (MMAS), functionality with~     the Fugl-Meyer scale for the upper limb, motor recovery with Brunnstrom Stages Scale (BSS)~     and upper limb spasticity pattern (ULP), pain by 10-points Numerical Rating Scale (NRS10) and~     the quality of life with the Euro QoL 5D 5L survey.~      In both groups the valuations will be made following the same schedule.~   "
7959|NCT03462680|"~     Inflammation plays a central role in Parkinson's disease. The use of anti-inflammatory drugs~     was found to reduce the risk of PD . Niacin may play an important role in reducing~     inflammation in PD. The investigators also found that individuals with PD have a chronic~     niacin deficiency .~      The purposes of this study are to (1) examine the blood, urine and spinal fluid of persons~     with Parkinson's to look for evidence of inflammation and; (2) whether 6 months of vitamin B3~     supplements may reduce the inflammation and/or improve symptoms.~   "
7960|NCT03462667|"~     The purpose of this study is to learn if the stoma boot camp is a good and effective way to~     help people adapt to life with a stoma after surgery.~   "
7961|NCT03462654|"~     In the Lifestyle-Integrated Functional Exercise (LiFE) program, exercises to increase~     strength and improve balance are embedded into daily life activities. Recurring daily~     activities and tasks are used as prompts for these exercises so that they are performed~     multiple times per day. However, implementing the original LiFE program includes high~     financial requirements and human resources as it comprises one-to-one supervision of~     participants. Therefore, it is investigated whether implementing LiFE in groups (gLiFE) is~     not inferior to the individually delivered LiFE (iLiFE) in terms of reducing falls per~     physical activity. In addition, gLiFE is expected to be more cost-effective as compared to~     iLiFE. In a multicenter non-inferiority trial, 300 participants aged 70 years or older with~     confirmed fall risk will be randomized into either the iLiFE or gLiFE arm of the study. Both~     arms will undergo the same strength and balance exercises and habitualization strategies as~     described in the LiFE program, however, based on different approaches of delivery (i.e.,~     group vs. individual).~   "
7962|NCT03462641|"~     This arm is a positron emission tomography (PET) biomechanistic GABA-A receptor target~     engagement study that includes detailed clinical and motor assessments before and after the~     i.v. administration of 1 mg flumazenil or placebo in Parkinson disease subjects. Each subject~     will receive 1mg flumazenil or placebo at two visits.~   "
7963|NCT03462628|"~     The primary objective of this investigation is to compare the efficacy of two different AF~     ablation strategies in older patients with paroxysmal AF: Pulmonary vein isolation alone~     versus additional low-voltage substrate modification during sinus rhythm~   "
7964|NCT03462615|"~     Malaria during pregnancy remains an important public health issue in endemic countries. Most~     cases of malaria in pregnant women are asymptomatic, and can contribute to adverse outcomes,~     such as maternal and neonatal anaemia as well as low birth weight. Infections that do not~     cause symptoms (sub-clinical infections) - particularly in low transmission settings -remain~     difficult to diagnose during pregnancy but can contribute to adverse outcomes e.g. growth~     restriction, premature birth, miscarriage and stillbirth.~      The Bill & Melinda Gates Foundation (BMGF) has supported the development of an HRP2-based~     high sensitivity rapid diagnostic tests (HS-RDT) that has analytical sensitivity ten times~     better than current RDTs and a sensitivity near 80% when compared to the 'gold standard' of~     quantitative polymerase chain reaction (qPCR). In this regard, the new HS-RDT may be a~     promising diagnostic and screening test for subclinical malaria during pregnancy.~      The overall aim is to compare the performance of novel high sensitivity rapid detection tests~     with conventional rapid diagnostic tests for Plasmodium falciparum malaria infection in~     pregnant women in Papua New Guinea~   "
7965|NCT03462602|"~     Introduction: The value of routine nasogastric tube (NGT) decompression after pancreatic~     surgeries is not yet established. Previous studies in the setting of abdominal surgery~     suggested that the use of NGT does not accomplish any of its intended goals.~      Methods/design: This is a prospective, randomized, controlled multicenter trial with two~     treatment arms. One group underwent pancreatic surgeries with routine NGT and was left in~     place after surgery until the patient passed flatus or stool. The other group underwent~     pancreatic surgeries without receiving NGT decompression, in which the NGT was removed at the~     end of surgery.~      Discussion: Routine NGT decompression after pancreatic surgeries does or does not appear to~     have its anticipated advantages would be discovered in this RCT.~   "
7966|NCT03462589|"~     This is a phase Ⅰ，single-center, randomized, double-blinded, placebo-controlled, single~     ascending dose trial of SY-008 in healthy subjects.~   "
33210|NCT03132324|"~     The purpose of this study is to evaluate the safety and tolerability, and the pharmacokinetic~     and biologic activity of INCB059872 in participants with sickle cell disease.~   "
7967|NCT03462563|"~     This is a prospective, randomized controlled study. The study population will include 220~     subjects scheduled to undergo laparoscopic radical resection of rectal carcinoma with~     preventive ileostomy (Phase 1 operation).~      During the Phase 1 operation, when the definite decision to create a temporary ostomy is~     made, patients will be randomized in 1:1 ratio to either the treatment arm (INTERCEED™) or~     the control arm (standard of care treatment: no adhesion barrier, no placebo). In subjects~     assigned to the treatment arm, the INTERCEED™ must be applied beneath the target incision~     site (the midline incision mainly for the removal specimen). The subjects will return 6-9~     months after the phase 1 operation (colorectal resection with temporary ileostomy) for phase~     2 operation, to have their diverting ostomy taken down (ileostomy reversal). During the phase~     2 operation (ileostomy reversal), the incidence, extent and severity of adhesions will be~     evaluated through the laparoscope from the ostomy site abdominal wall opening before~     submersion of the bowel loop into the peritoneal cavity and abdominal wound closure~   "
7968|NCT03462550|"~     The Laryngeal Mask Airway is a supraglottic airway device that has been used in anesthesia~     for decades. Now the third generation (LMA Supreme) is commonly used. Recently the LMA~     Protector is manufactured.~      The primary hypothesis of this study is: the oropharyngeal leak pressure of the LMA Protector~     is 5 cmH2O higher than the oropharyngeal leak pressure of the LMA Supreme. Secondary outcome~     measures are: ease of insertion, fibreoptic position, ease of gastric tube placement.~      Differences between LMA Supreme and LMA Protector are: the LMA protector has a dual gastric~     drainage channel, LMA supreme one. For LMA protector, airway tube and cuff are 100% silicone,~     in LMA supreme the cuff is polivinylchloride. Silicone cuffs have shown to reduce risk of~     sore throat and achieve higher seal pressures. There are no aperture bars in the LMA~     protector (2 in LMA supreme). The tube of LMA protector is more flexible. An integrated cuff~     pressure indicator for single use airway management devices that enables continuous cuff~     pressure monitoring only in the LMA protector.~   "
7969|NCT03462537|"~     The purpose of the present study was to evaluate the effects of one session of aerobic~     exercise associated with low level laser therapy in lipolytic activity, lipid profile and~     inflammatory markers (C-reactive protein - CRP).~   "
7970|NCT03462524|"~     Although recent global trends indicate reduced postoperative mortality after esophagectomy,~     major morbidity, in particular pulmonary, remains high, with considerable health and economic~     costs. In a recent modern international collaborative series of 2704 patients from~     high-volume centers, with an approximate equal mix of open and minimally invasive approaches,~     respiratory complications were evident in 28% of patients, pneumonia in 15%, and respiratory~     failure in 7%.1 In other series, respiratory failure is reported in up to 15% of patients and~     is the most common cause of mortality. Prediction of risk and prevention of respiratory~     morbidity is therefore of considerable importance, and in this context baseline assessment of~     respiratory physiology compliments clinical assessment, history and enhanced recovery~     pathways representing key elements of current patient management.~      In this study, which will include all prospective patients with locally advanced esophageal~     cancer treated at a National Center, pulmonary function will be systematically measured~     before and after neoadjuvant therapy. The investigators seek to evaluate the incidence of~     radiation induced lung injury (RILI), as well as subclinical changes in pulmonary physiology~     that may be linked to postoperative complications, and quality-of-life in survivorship, and~     to compare cohorts who received radiation therapy or chemotherapy alone, preoperatively.~   "
7971|NCT03462511|"~     Many youth with chronic disease have difficulty taking medication every day and therefore do~     not receive full benefit from treatment. Sickle Cell Disease (SCD) is an inherited blood~     disease that affects African Americans and other underserved communities. Hydroxyurea (HU) is~     the sole FDA-approved drug therapy for SCD and is highly effective and improves quality of~     life. The proposed study, a 5-site four-year randomized control trial (RCT), builds upon the~     investigators' recent feasibility study of the same title. Overall goals are reducing~     barriers to HU use and improving adherence for youth 10-18 years through creation of a daily~     medication habit. The goal of the proposed multi-site study is to test the efficacy of the~     HABIT intervention at 6 months and sustainability of the effect at 12 months.~   "
7972|NCT03462498|"~     The purpose of this study is to evaluate the safety of reducing dual antiplatelet therapy~     (DAPT) duration to 1 month after implantation of the everolimus-eluting cobalt-chromium stent~     (CoCr-EES) under the setting of acute coronary syndrome (ACS).~   "
7973|NCT03462485|"~     The research question for this study is whether golf is a suitable physical activity for~     people with dementia (PWD). It follows a qualitative pilot study in Lincoln where PWD enjoyed~     the activity and caregivers appreciated the service. Golf combines many desirable elements in~     a physical activity programme that include being outdoors, social, cognitively challenging,~     no reaction-time component, and being a typical everyday activity. The length of time that~     golf sessions last could also offer a potential respite from care for caregivers.~      Participants will be people with dementia and their caregivers. Eligibility criteria will~     include having been clinically diagnosed with dementia, being able to stand on one leg for at~     least six seconds to ensure participants are able to balance sufficiently well to be able to~     play golf. The study will be undertaken at The London Shire Golf Club, with the golf training~     provided by the Golf Trust, which is a charitable foundation experienced in providing golf~     training to people with a range of different disabilities.~      The randomised controlled trial study will last 16 weeks, with a partial crossover design.~     The experimental group with have two eight-week periods of golf while the control group will~     have eight weeks without golf, then the golf intervention. There will be two 150-min sessions~     each week, starting with 30 minutes socialising, then 90 minutes playing golf, then 30~     minutes socialising. The golf sessions will progress from putting, to chipping, and then a~     full swing, with sessions taking place on a nine-hole golf course. Participants will be~     evaluated before and after each eight-week period for physical function, physical activity~     level, cognitive function, and quality of life. Their caregivers will also provide~     information related to the PWD in terms of quality of life and psychopathology in dementia,~     as well as their own quality of life.~   "
7974|NCT03462472|"~     Peripheral arterial disease (PAD) is characterized by poor circulation in the lower~     extremities that often provokes claudication (leg pain, numbness, and heaviness) with~     physical exertion. The aim of this research protocol is to determine the effect of two~     non-invasive treatment modalities on leg blood flow and exercise capacity in those with PAD.~     Specifically, we are measuring popliteal artery blood flow (Doppler ultrasound), toe oxygen~     saturation, ankle-brachial index (ABI), and 6-minute walking distance (6MWD) in men and women~     who have intermittent claudication (Fontaine Stage II; Rutherford Category 1-2) in response~     to 15 or 45 minutes of lower limb heating and transcutaneous electrical nerve stimulation~     (TENS).~   "
9136|NCT03447262|"~     This study will evaluate the long-term safety and tolerability of VX-659 in triple~     combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis~     (CF), including but not limited to those who are heterozygous for the F508del mutation~   "
7977|NCT03462433|"~     Ruptured intracranial aneurysms is currently a common disease that seriously affects human~     health and quality of life due to its high morbidity,high mortality and high disability. At~     present,Ruptured intracranial aneurysms are treated with craniotomy clipping and~     interventional embolization ,but for ruptured wide-neck intracranial aneurysms, the treatment~     of craniotomy clipping and coiling embolization are not effective.With the improvement of~     endovascular treatment materials and techniques, three dimensional coil basket technique,~     double microcatheter technique, balloon assisted ONYX embolization, simple stent covered~     aneurysm neck, balloon or stent assisted neck remodeling and coil embolization are used in~     endovascular treatment of ruptured wide-neck intracranial aneurysms. The treatment methods~     are different in the intervention effect of ruptured wide-neck intracranial aneurysms, for~     example, the complications of interventional therapy are lower than craniotomy clipping,but~     the rate of well functional outcome (mRS ≤2) differed significantly by 3 months follow-up~     (65.0% vs.75.0%), and there is not standard of treatment in different parts of ruptured~     wide-neck intracranial aneurysms in our country, the choice of interventional therapy or~     craniotomy clipping are different in different clinical centers; on the other hand, there are~     serious problems in the treatment of ruptured wide-neck intracranial aneurysms, because~     without the relevant guidelines of diagnosis and treatment of ruptured wide-neck intracranial~     aneurysms, different clinical centers will cause excessive treatment of ruptured wide-neck~     intracranial aneurysms, not only bring unreasonable utilization of medical resources, but~     also cause the subject's life and property to be threatened.~      The patients with ruptured wide-neck intracranial aneurysms(n=1084) and unruptured~     intracranial aneurysms(n=300) were included in prospective cohort study, after interventional~     therapy and craniotomy clipping, setting fixed time for postoperative follow-up, the clinical~     data and image data were recorded, the safety, efficacy and economic benefits of~     interventional treatment and craniotomy clipping were compared, providing strategies for the~     standardized treatment of ruptured wide-neck intracranial aneurysms.~   "
7978|NCT03462420|"~     This pilot randomized trial will compare the preliminary effect of a regular physiotherapy~     (PT) program to a regular PT combined with a progressive walking program (PT+) in patients~     with and without diabetes who have adhesive capsulitis. After signing the consent form,~     recruited participants will be randomized into either PT group (control) or PT+ group~     (experimental). Participants in both groups will be referred to a physical therapy facility.~     The intervention will be chosen by treating physical therapist. In PT+ group, participants~     will also be asked to perform free walking at their own pace. Outcomes measures for the~     primary outcome (shoulder functional performance) will be evaluated at baseline and after 6~     weeks. Secondary outcomes (shoulder ROM, pain and function, muscle strength, and physical~     activity level) will be evaluated at baseline, at 3 and 6 weeks, and again at 3 and 6 months~     after enrolment. We expect adding a progressive walking program to regular PT will result in~     better outcomes.~   "
7979|NCT03462407|"~     This R21 application will provide a multidisciplinary One Health approach to DAID physical~     activity intervention for adolescents with developmental disabilities and their family dog.~     The novel intervention approach includes the use of the family dog in an established dog~     training protocol, focused on physical activity and aimed at improving physical activity,~     quality of life and social wellbeing for children with developmental disabilities. Recent~     pilot work has revealed physical and social-emotional improvements in children with~     developmental disabilities following an animal assisted intervention. There has been~     relatively limited research focused on the physical activity of adolescents with~     developmental disabilities and there remains a critical need to develop strategies that will~     encourage an active lifestyle for adolescents with developmental disabilities. Animal~     assisted therapy has known positive impacts on morale and is also known to reduce depressive~     psychological symptoms for children and adults. Yet, traditional 'service dogs' are~     prohibitively expensive for many families. Dog ownership alone is known to improve~     health-related physical activity. Thus, a critical need exists to create physical activity~     interventions that are easily accessible and provide manageable home-based physical activity~     adherence, but that are less expensive than traditional service dogs. To achieve these goals~     the investigators of this project have developed the following specific aims: 1) To develop~     and evaluate a novel DAID dog training program to promote physical activity in children with~     developmental disabilities; 2) To determine what impact participation in a DAID dog-training~     program has on the child's quality of life, feelings of social wellbeing and the child-dog~     relationship. The long term goal of this research is to improve the lives of adolescents with~     developmental disabilities. This research supports the One Health initiative and brings~     together aspects of improving health related to human and animal development.~   "
7980|NCT03462394|"~     NYU Langone Health calls patients to remind them to schedule their annual well-health~     appointments (including annual well visit, mammograms, etc.). The proposed study will test~     different iterations of the call script with the goal of increasing call completion rate and~     the number of scheduled appointments within an appropriate timeframe.~   "
7981|NCT03462381|"~     Participants will perform three endurance training sessions weekly for 12 weeks. All~     participants will be randomly assigned to the protein supplementation group or the placebo~     (iso-caloric carbohydrate) group. During the 12 weeks endurance training program participants~     allocated to the protein group (30 g protein per beverage) will receive a protein drink after~     exercise and prior to sleep at night on training days. On non-training days participants will~     only receive a protein drink before sleep. Participants allocated to the carbohydrate group~     (30 g carbohydrates) will receive a carbohydrate drink instead of a protein drink.~   "
7982|NCT03462368|"~     The aim of this study was to evaluate the effect of two different treatment agents used in~     conjunction with subepithelial connective graft technique on root coverage outcomes in~     multiple recession defects. Half of patients will receive root treatment with antimicrobial~     photodynamic therapy and the other half will receive photobiomodulation therapy by laser on~     surgery site.~   "
7983|NCT03462355|"~     Certain studies reported that cigarette by-products may make the cornea more rigid,~     suggesting that it could lead to natural CXL of collagen fibers, hence a protective effect~     for KC. Others have reported that cigarette smoking causes no significant changes in the~     corneal biomechanics. The aim of this study was to assess a possible link between keratoconus~     (KC) occurrence and patients' smoking habits.~   "
7984|NCT03462342|"~     Investigational agent, AZD6738 will be given in combination with Olaparib to women with~     recurrent ovarian cancer (platinum-sensitive or platinum-resistant).~      This study will determine if using Olaparib in combination with AZD6738 is safe and tolerable~     and also determine the objective response rate and progression free survival of combination~     of AZD 6738 and Olaparib in women with recurrent ovarian cancer in distinct Pt-sensitive and~     Pt-resistant cohorts.~   "
7985|NCT03462329|"~     The investigators will focus on pretreatment expectations of patients with early Lyme disease~     manifested as erythema migrans with the aim of assessing the association between pretreatment~     expectations quantified with a questionnaire and treatment outcome quantified with the~     presence of post-Lyme symptoms. Furthermore, the investigators will compare the prevalence of~     nonspecific symptoms among patients and among age-matched controls without a history of Lyme~     borreliosis.~   "
7986|NCT03462316|"~     The main purpose of this trial is to investigate the safety and tolerability of NY-ESO-1（TCR~     Affinity Enhancing Specific T cell Therapy）in the first-line treatment failed advanced bone~     and soft tissue sarcoma. The secondary purpose of this trial is to investigate the efficacy~     of NY-ESO-1（TCR Affinity Enhancing Specific T cell Therapy）in the first-line treatment failed~     advanced bone and soft tissue sarcoma.~   "
8256|NCT03458780|"~     The immune system is composed of diverse cell types with different functions that act~     together in order to defend against infection. This pilot study will test a new technology~     for studying these many different cell types at very large numbers at the level of individual~     cells. This method will then be used to identify the cell types and functions important for~     the immune response to the highly protective yellow fever vaccine, which will improve our~     understanding of effective vaccine features.~   "
7987|NCT03462303|"~     The dorsolateral prefrontal cortex (dlPFC) and dopamine (DA) have been implicated in the~     control of cognitive flexibility. However, while a great deal of what it is know regarding a~     causative relationship between cognitive flexibility and its neuronal underpinning comes from~     animal studies, human data have largely been correlational (i.e. imaging investigations). In~     a recent study, the current research group examined whether putative increases in dopamine~     levels through tyrosine administration and blockage of these by cathodal (i.e. inhibitory)~     transcranial direct current stimulation (tDCS) of the dlPFC could be causally related to~     cognitive flexibility as measured by task switching and reversal learning.~      The next step involves finding a way of lowering dopamine concentrations while anodal (i.e.~     excitatory) stimulation of the dlPFC is applied and cognitive flexibility measured. One~     experimental approach to reduce global DA synthesis and transmission is through acute~     phenylalanine and tyrosine depletion (APTD). This dietary intervention involves the~     administration of an amino-acid mixture lacking in tyrosine and phenylalanine, which can be~     used to selectively lower DA synthesis in humans.~   "
7988|NCT03462290|"~     The main objective of this study is to investigate efficacy and safety of injecting botulinum~     toxin towards the sphenopalatine ganglion using MultiGuide in patients with persistent~     idiopathic facial pain~   "
7989|NCT03462277|"~     The purpose of this trial is to investigate the relationship between DNA methylation and~     hydroxymethylation and the expression of DNMTs, TET family gen and coronary heart disease.~   "
7990|NCT03462264|"~     This is a second study in a series of 3 studies. The first study assessed exercise compliance~     of scoliosis patients (adults and children). This study will look at different strategies to~     improve exercise compliance after a patient has completed an intensive course of treatment at~     Scoliosis SOS Clinic. It will be a randomised control trial. The control group will receive~     the regular exercise schedule that is created for the patients at the clinic, there will be~     two intervention groups, one using the exercise schedule with a diary and one using the~     exercise schedule with a mobile application. Compliance will be monitored through a~     questionnaire at their first and second check-up appointments which will take place every 3~     months for a patient under the age of 18 and every 6 months for a patient who is 18 years old~     or over.~   "
7991|NCT03462251|"~     This study is designed to evaluate the efficacy and safety of first-line treatment ribociclib~     in combination with aromatase inhibitor (AI) or paclitaxel with / without bevacizumab in~     patients with HR-positive, HER2-negative advanced breast cancer with visceral metastasis.~      Half of the patients will receive a combination of ribociclib and AI while the other half~     will receive paclitaxel +/- bevacizumab.~   "
7992|NCT03462238|"~     Arterial calcifications (AC) are constant lesions in patients with Chronic Kidney Diseases~     (CKD). Renal transplantation would reduce their progression compared to dialysis. AC~     pathophysiology is a complex and finely regulated process that involves many local and~     systemic factors, both pro- and anti-calcification. The progression of the CKD is accompanied~     by an increase in phosphate levels as the renal excretion capacity of inorganic phosphates~     (Pi) decreases while their digestive absorption remains unchanged. Hyperphosphatremia is a~     well-identified calcifying factor contributing to ACs in the CKD. On the other hand,~     pyrophosphate (PPi) is an anti-calcifying factor from the hydrolysis of extracellular ATP by~     ectonucleotidases. While there are many factors that may contribute to a protective effect~     against AC progression of renal transplantation, no study has been yet analysed the role of~     PPi. Plasma concentration of PPi is decreased in dialysis patients compared to non-kidney~     failure patients.~      The main objective of this monocentric, prospective and interventional pilot study will be to~     compare the progression of CA and [PPi]pl between a group of renal transplant patients over~     the past 24 months and a group of dialysis patients over the same period of time. The~     secondary objectives will be to compare the progression of ACs and the ratio[PPi]pl/[Pi]pl~     between transplanted and dialysis patients. Transplanted patients will be included within 24~     (±3) months of transplant. Dialysis patients will be included at 24 (±3) months of the CT~     scan performed during the pre-transplant check-up. At inclusion, all patients will benefit~     from a CT scan without injection and a plasma dose of PPi, Pi and other factors involved in~     controlling calcification.~   "
7993|NCT03462212|"~     This trial is a randomized, open-label Phase II multi-center study designed to evaluate the~     effect of first line therapy of Carboplatin-Paclitaxel-Bevacizumab (in combination and~     maintenance) vs Carboplatin-Paclitaxel-Bevacizumab-Rucaparib (Rucaparib only in maintenance)~     vs Carboplatin-Paclitaxel-Rucaparib (Rucaparib only in maintenance) on progression-free~     survival in patients with advanced high grade ovarian cancer.~      The randomized phase of the study will be preceded by a single arm Phase I study aiming at~     evaluating the MTD of the combination Rucaparib-Bevacizumab. Once the MTD has been reached~     the randomized study will start.~   "
7994|NCT03462199|"~     Low and High doses of Actazin and Livaux will be compared against a control formula and~     placebo to evaluate how each investigational study product effects complete spontaneous bowel~     movements in healthy adults that currently experience less than or equal to 3 complete~     spontaneous bowel movements per week. During the 28-day study period, it is hypothesized that~     participants consuming Acatzin, Livaux, or control formula will have an increased number of~     complete spontaneous bowel movements when compared to participants consuming the placebo. It~     is hypothesized that participants consuming Actazin or Livaux will respond more than~     participants consuming the control formula. It is hypothesized that participants consuming~     Actazin or Livaux will have a favorable microbiome change than placebo.~   "
7995|NCT03462186|"~     Clinical preventive services (CPS) are fundamental to early disease detection and improvement~     of health outcomes but are often poorly understood and utilized by patients. Myhealthfinder~     is a web-based tool developed by the Office of Disease Prevention and Health Promotion~     (https://healthfinder.gov). This study tests the prescription of myhealthfinder to engage~     patients in CPS, improve patient-clinician communication and increase uptake of CPS.~   "
7996|NCT03462173|"~     The Safety, Tolerability and Pharmacokinetic Study of Chronic Hepatitis C Treatment Drug~     Yimitasvir in Healthy Adults Subjects.~   "
7997|NCT03462160|"~     The investigators aim to assess the effectiveness of prophylaxis of urinary tract infections~     in children with a probiotic containing Lactobacillus rhamnosus PL1 and Lactobacillus~     plantarum PM1. It is formulated a hypothesis that a 3-months course of probiotic prophylasis~     is more effective than placebo.~   "
7998|NCT03462147|"~     When patients suffer from chronic pain after multiple back surgeries, this is denominated as~     the 'failed back surgery syndrome'. A possible treatment for these patients is spinal cord~     stimulation. This is an invasive treatment where no other treatment options (medication,~     minimal invasive treaments) can offer progress to the patients' health status. In spinal cord~     stimulation, an electrode will be placed at the spinal cord under local anaesthesia whereas~     via a battery a painless electrical stimulation will arise. Clinical research have~     demonstrated that a new way of spinal cord stimulation can improve back and leg pain~     significantly. This will lead to a better quality of life for the patients and a decreased~     use of medications. In Ziekenhuis Oost-Limburg, different manners of spinal cord stimulation~     will be compared to each other.~   "
7999|NCT03462134|"~     In this study the investigators examined the ability of orthopaedic surgeons to predict the~     outcome of surgery and non-operative treatment in patients (age 45 to 70) with a~     non-obstructive meniscal tear.~   "
8000|NCT03462121|"~     This study is a randomized, double-blind, placebo-controlled, multicentre, Phase 2 study,~     with an optional open-label extension, to evaluate the safety, tolerability, and efficacy of~     RPh201 in subjects with mild to moderate AD who are eligible for enrollment in this study.~      Subject participation will include a Screening Phase, Treatment Phase, and an Optional~     Open-Label Extension. The Screening Phase will be up to 4 weeks prior to randomization. At~     Visit 2, Subjects will be randomized 2:1 to RPh201 or placebo. The Treatment Phase will last~     for 6 months post-randomization, or until subject withdrawal from the study, whichever comes~     first. The Optional Open-Label Extension will begin once a subject has completed the~     Treatment Phase and has signed an informed consent form to continue on the study. The~     Optional Open-Label Extension will continue for 6 months, or until subject withdrawal from~     the study, whichever comes first.~   "
8001|NCT03462108|"~     This study is to assess the safety of Rotavirus (Bio Farma) vaccine in adults, children and~     neonates.~   "
8002|NCT03462095|"~     No high-dose methotrexate (MTX) and high-dose cytarabine (ARA-C) consolidation blocks,~     L-asparaginaseis scheduled for 1 year of treatment, 21 intrathecal injections through the~     whole treament, T-ALL patients in complete remossion (CR) after the informed consent are~     randomized to: auto-HSCT vs no auto-HSCT, - with the similar further maintenance. Stem cell~     harvest is performed after the 3rd consolidation by G-SCF disregarding minimal residual~     disease (MRD) level. Auto-HSCT is planned after the 5th consolidation phase. All primary bone~     samples are collected and tested for cytogenetics and molecular markers, all included~     patients are monitored by flow cytometry by aberrant immunophenotype in a centralized lab.~   "
8003|NCT03462082|"~     This single-center, randomized, double-blinded, double-crossover comparative efficacy trial~     will study the effects of unilateral 50% voltage reduction in axial motor dysfunction for~     patients with Parkinson's disease that develop treatment-resistant postural stability gait~     dysfunction after bilateral subthalamic nucleus deep brain stimulation surgery.~   "
8004|NCT03462069|"~     Primary Objective:~      To compare the metabolic and gastrointestinal pharmacodynamic (PD) effects of an 8 weeks~     treatment with sotagliflozin once daily (QD) to an 8 weeks treatment to empagliflozin QD in~     mild or moderate hypertensive T2DM patients on a stable treatment regimen with metformin and~     an angiotensin converting enzyme (ACE) inhibitor or Angiotensin Receptor Blocker (ARB) under~     standardized diet conditions.~      Secondary Objectives:~        -  To compare the renal and cardiovascular PD effects of an 8 weeks treatment with~          sotagliflozin QD to an 8 weeks treatment to empagliflozin QD in mild or moderate~          hypertensive T2DM patients on a stable treatment regimen with metformin and an ACE~          inhibitor or ARB.~        -  To evaluate the safety and tolerability of an 8 weeks QD treatment with sotagliflozin or~          empagliflozin in mild to moderate hypertensive T2DM patients on a stable treatment with~          metformin and an ACE inhibitor or ARB.~        -  To evaluate the pharmacokinetic (PK) profile of sotagliflozin in steady state~          conditions.~   "
8005|NCT03462056|"~     Children with cystic fibrosis require increased caloric intake to maintain appropriate~     growth, an important determinant of long-term outcomes. This study seeks to determine the~     feasibility of using a novel therapeutic food to promote weight gain and growth in children~     with cystic fibrosis.~   "
8006|NCT03462043|"~     This study will assess the relative bioavailability of s.c. infused ND0612 versus jejunally~     infused CLES in patients with advanced PD.~   "
8007|NCT03462030|"~     The purpose of this study is to determine whether baked milk oral immunotherapy is safe in~     the treatment of cow's milk allergy.~   "
8008|NCT03462017|"~     Primary Objective:~      To assess the pharmacodynamic effects of SAR247799 on macrovascular endothelial function of~     the brachial artery using flow-mediated dilation (FMD) in patients with type 2 diabetes~     mellitus (T2DM).~      Secondary Objective:~        -  To assess the pharmacodynamic effects of SAR247799 on microvascular endothelial function~          using laser Doppler perfusion monitoring in patients with T2DM.~        -  To assess the safety profile of SAR247799 in patients with T2DM.~        -  To assess the plasma pharmacokinetic profile of SAR247799 in patients with T2DM.~   "
8009|NCT03462004|"~     The purpose of this study is to evaluate the safety, infectivity, and immunogenicity of two~     doses of the HPIV3/ΔHNF/EbovZ GP vaccine candidate when administered intranasally in healthy~     adults.~   "
8010|NCT03461991|"~     Corneal dystrophies are usually classified histopathologically according to the layer of the~     cornea that is affected. The International Committee for the Classification of Corneal~     Dystrophies (IC3D) takes this anatomical classification as referral with summarizing~     clinical, genetic, and pathological data.~      Most of this classification relies on slit lamp findings or histologic specimen, since~     in-vivo imaging of corneal microstructures has only become available in the recent years.~     With confocal microscopy it is possible to image corneal microstructures at a high~     resolution, but this technique is limited by its reduced repeatability and the fact that only~     a small area can be imaged. By the use of optical coherence tomography (OCT) systems it is~     possible to overcome these limitations. Commercially available systems, however, only have an~     axial resolution of about 18 µm which is not sufficient for imaging of all corneal layers.~      Recently, a high-resolution optical coherence tomography (OCT) system was developed at the~     Center for Medical Physics and Biomedical Engineering that enables a resolution of about 1~     µm. With this resolution, all corneal structures and several pathologies can be visualized.~      In the present study the investigators want to use this OCT system to image corneal~     dystrophies in patients scheduled for corneal transplantation.~   "
8011|NCT03461978|"~     The development of optical coherence tomography (OCT) and its application for in vivo imaging~     has opened entirely new opportunities in ophthalmology (Wojtkowski, Kaluzny et al. 2012;~     Drexler, Liu et al. 2014). The technology allows for both noninvasive visualization of the~     morphology and measurement of functional parameters within ocular tissues to a depth of a few~     millimetres even in nontransparent media. Until now the resolution of commercially available~     OCT systems is, however, much lower than that provided by light microscopy.~      Recently, an ultrahigh-resolution OCT system was developed by our group providing resolutions~     of 1.7 and 17 µm in axial and lateral direction, respectively. This axial resolution is about~     four times better than that provided by standard OCT systems. It allows to perform in vivo~     imaging with a resolution close to biopsy of tissue and to visualize structures of the~     anterior eye segment with a remarkable richness of detail. The prototype was applied for in~     vivo imaging of the cornea including the precorneal tear film (Werkmeister, Alex et al.~     2013).~      The goal of the planned pilot study is to apply this innovative imaging modality for~     visualization of the ultrastructure of the different parts of the anterior eye segment~     structures in diseased subjects, as well as in patients who underwent minimally invasive~     glaucoma surgery (MIGS). The obtained in vivo cross sectional images and three-dimensional~     data sets are hoped for contributing to the knowledge about the anatomy and physiology of the~     corresponding tissues. This could allow for a better interpretation of clinical features and~     findings obtained in slit lamp examination.~   "
8012|NCT03461965|"~     Patients undergoing Mohs micrographic surgery frequently experience anxiety. It has been~     suggested that enhanced patient education prior to the procedure may decrease patient~     anxiety. The purpose of the study is to investigate if optimized patient education enhances~     patient understanding, decreases patient anxiety and increases patient satisfaction.~   "
8013|NCT03461952|"~     The purpose of this study is to determine the safety and effectiveness of nivolumab alone or~     in combination with ipilimumab in patients with metastatic or unresectable tumors harbouring~     mutations in genes, POLE and POLD1. These mutations will be determined by plasma cfDNA.~     Nivolumab and ipilimumab have been given to patients across multiple types of cancer, and~     safe doses and schedules have been determined.~   "
8014|NCT03461939|"~     New treatments are continually being developed to help patients living with advanced cancer,~     which require extensive clinical trials before authorisation for standard clinical use.~     Reporting of adverse events (AE) in this setting is essential to ensure treatment safety and~     tolerability. The current system for reporting AEs, the Common Toxicity Criteria and Adverse~     Events (CTCAE) relies on the clinician's interpretation of patient symptoms, but a~     substantial body of evidence suggests clinicians miss/underestimate AEs experienced by~     patients. The aim of the overall project is to explore the implementation of an electronic~     patient-reported outcomes (ePRO) system to gather adverse events data in early phase clinical~     trials (EPCT) patients. In Phase 1 of this study, through semi-structured interviews, we~     explored patient, healthcare, and clinical trial staffs' views about collecting electronic~     patient-reported outcomes in this setting. This work informed the direction of the current~     pilot. This proof-of-principle feasibility study will explore the feasibility and~     satisfaction with using an electronic system to remotely self-report AEs whilst on EPCT. The~     key objectives are to:~        1. Evaluate the feasibility of using a secure online method (ePRIME system) to collect~          PRO-AEs in EPCT patients.~        2. Explore patient satisfaction with the use of the ePRIME system to collect PRO AEs in~          EPCT patients.~        3. Monitor the number of notifications for severe AEs generated by the system to address~          concerns from the interviews that ePROs will lead to increased workload.~      To this end, a prospective longitudinal pilot will be conducted of the ePRIME system in early~     phase clinical trial patients in Leeds and Sheffield. A convenience sample of patients~     enrolled in Phase I or Phase II trials will be recruited. Patients in general oncology and~     haematology clinics will be included if diagnosed with metastatic or progressive disease and~     are presently receiving novel agents in an academic early phase clinical trial, such as~     chemotherapy, targeted agents, or chemo-radiotherapy. Patients will be included in this pilot~     whether the trial is a test of a novel drug, drug combination, or dose escalation. The study~     will aim to identify, approach, and consent all eligible patients over a 12 month period. If~     they are over 18, able to give informed consent, have access to internet via any device, and~     able to read and understand English. Patients will be approached and consented within 1 month~     of having been entered in the clinical trial. Patients will not be eligible if they will be~     on the clinical trial for less than 3 months. Each patient will complete a patient-reported~     AE checklist at baseline (i.e. time of consent) and then weekly for 12 weeks. At the end of~     the 12 weeks an end-of-study interview will be conducted to explore patient satisfaction with~     the system. It is envisaged that this project will provide initial information on the~     feasibility and acceptability of a novel electronic system to facilitate the collection of~     patient-reported AEs in early phase trials.~   "
8015|NCT03461926|"~     Societal changes have resulted in reduced demands to be active and increased daily time spent~     sitting. Sedentary behavior (SB) has been linked to many health problems such as type 2~     diabetes and heart disease. Office-working adults are a high-risk population for excessive~     SB. Increasing the length and frequency of breaks from sitting and increasing the time spent~     standing and engaged in light physical activity are ways to decrease SB. The purpose of this~     study is to determine whether combining a Health Action Process Approach-based~     (theory-driven), specifically action and coping planning intervention, with a tailored text~     messaging intervention can reduce workplace sitting time among adult office workers.~     Participants in the intervention group will receive one behavioural counselling session,~     followed by daily, tailored text messages over a 6-week period, with a focus on encouraging~     them to reduce their occupational sitting time by increasing their frequency and duration of~     breaks from sitting, as well as time spent standing and engaged in light-intensity physical~     activity. It is expected that office-working adults who receive the planning intervention and~     tailored text messages will report greater increases in non-sedentary behaviours (e.g., break~     frequency, break duration, standing, light physical activity) than those who do not receive~     the intervention.~   "
8016|NCT03461913|"~     Patients were classified into two equal groups using the presence or absence of hypertension~     during pregnancy into: hypertensive group (BP>140/90) and normotensive group (BP≤140/90. The~     surgical time intervals are assessed and classified the patients accordingly into short and~     log time interval subgroups (induction of regional anesthesia to delivery (I-D), initial skin~     incision to delivery (S-D), and uterine incision to delivery (U-D)~   "
8035|NCT03461653|"~     The guidance on Safe abortion technology by the World Health Organization (WHO 2012) suggests~     the evaluation of internet provision and telemedicine, as further alternative service~     delivery channels of safe abortion, as a subject for future research (WHO 2012) Our studies~     have shown that telemedicine and provision of medical abortion through wow is safe,~     acceptable and with outcomes similar to medical abortion provided traditionally following~     face-to-face counselling. Furthermore, recently home self-assessment of the abortion outcome~     through a low sensitivity U-hCg test was shown to be highly acceptable to women. To evaluate~     whether counselling through telemedicine is non-inferior to face-to face counselling a RCT~     will be conducted including women who chose medical abortion up to 63 days of gestation with~     home administration of misoprostol and self assessment of the outcome. The results of this~     study could be of major importance to increase access to safe and acceptable abortion~     services.~   "
8017|NCT03461900|"~     Many observational studies have highlighted an independent association between fluid overload~     and clinical outcomes during septic shock. To optimize fluid balance, clinician has several~     options to consider carefully fluid administration and avoid fluid overload. More than a~     general restrictive approach, a pragmatic, individual tailored approach should be considered~     to optimize patients' hemodynamics during acute circulatory failure. Many advances in~     hemodynamic monitoring were described. Mini-fluid challenge appears to be a sensible method~     to use for bedside assessment to optimize fluid infusion. The next step for hemodynamic~     management in the ICU should be to test a hemodynamic goal-directed approach to better~     control fluid management and eventually improve patient's outcome. The main objective of the~     GOAL study is to evaluate a pragmatic optimization fluid management protocol tailored to each~     patient's hemodynamic status based on mini-fluid challenges. This intervention will be~     compared to usual management based on the latest guidelines. This intervention aims to~     decrease organ dysfunction during septic shock. This is the first large clinical trial~     designed to test this hypothesis.~   "
8018|NCT03461887|"~     The aim of this study is to assess the effectiveness of a home-based exercise training~     program in COPD patients who have completed a pulmonary rehabilitation.~   "
8019|NCT03461874|"~     The aim is to compare the effectiveness of a behavioral treatment, the Acceptance and~     Commitment Therapy, provided as an add-on to the prophylactic treatment (treatment as~     usual-TaU) against TaU only on the reduction of monthly headaches frequency over 12 months in~     a sample of patients with high-frequency migraine without aura (i.e. reporting 9-14 days with~     headache per month in the previous three months).~      ACT will be provided in small groups (5-7 patients each) by specifically trained therapists.~     The ACT consists in 6 weekly sessions, 90 minutes each, and 2 supplementary booster~     sessions, at two and four weeks after the conclusion of the weekly session. The main focus of~     the six ACT session will be the following: 1) Creative helplessness: the problem of control;~     2) Identifying values: introduction to Mindfulness; 3) Actions guided by values: working with~     thought; 4) Working with Acceptance and Willingness; 5) Committed Actions: self-as-context;~     6) Integration: working with obstacles - wrap-up. The booster session starts with a~     mindfulness exercise, followed by a review of the contents covered across the ACT program.~      TaU will consist of education of patients, followed by pharmacological prophylaxis.~     Prophylaxis is prescribed based on patients' profile, such as previous failures,~     contraindications and so on by a neurologist with expertise in headache treatments and~     limited to Topiramate, Propanolol, Amytriptiline or Calcium channel blockers.~      The study will be a Phase II Trial; randomized, Open-Label; Multicenter study. Patients will~     be randomized 1:1 to the two groups: 64 patients (32 per group) will be enrolled to detect an~     absolute difference of at least 2 migraine days/month in the experimental group (assuming~     alfa 5%, power 95%, up to 15% loss to follow-up).~   "
8020|NCT03461861|"~     The purpose of this project is to test the hypothesis that a low dose of levetiracetam can~     reduce abnormal hyperfunctional activity in the hippocampus in normal, healthy adults who are~     APOE 4 carriers. The investigators will compare the results to normal, healthy adults who are~     APOE 4 non-carriers.~   "
8021|NCT03461848|"~     The Children and Young People's Health Partnership (CYPHP) Evelina London model is an~     innovative, evidence-based approach to reshaping healthcare services in Southwark and~     Lambeth. The model of care is a complex health services public health intervention aiming to~     integrate care across organisational and professional boundaries. There is a major focus on~     improving front line care for all children and young people, and comprehensive proactive care~     for those with common and long-term conditions such as asthma, epilepsy, eczema, and~     constipation~      CYPHP Evelina London model of care is being adopted by the Clinical Commissioning Groups of~     Southwark and Lambeth as part of routine care. Early roll out of the model has already~     started. However, due to resource limitations, implementation will occur in phases. In the~     first phase (~two years), half of GP practices in the Lambeth and Southwark area will~     implement the full model while others will offer enhanced usual care (EUC). The evaluation~     team will utilize this staged CCG roll out to evaluate the programme using a cluster~     randomised controlled trial design. It is expected that all the EUC practices will also adopt~     the CYPHP model within the next three years.~      The impact of the CYPHP Evelina London model will be assessed at two levels; at the~     population level (Population evaluation) and among CYP with specific conditions (Tracer~     condition evaluation). The tracer condition evaluation will with consent, follow up CYP with~     tracer conditions (asthma, epilepsy, eczema, constipation) to assess the impact of the new~     model of care on health service use, quality of care, and child health measures including~     health-related quality of life. Cost-effectiveness will be assessed for population and tracer~     conditions.~   "
8022|NCT03461835|"~     In a randomized multicenter trial we want to compare the ability of two hCG-based models in~     correctly classifying EPs as high risk among PULs and correctly classifying IUPs and failed~     PULs as low risk after two hCG measurements.~      After the classification of PULs into high or low risk of EP, the clinical management will be~     the same within each risk group (high and low) regardless of randomization group (which model~     classified the patients). The clinical management will be according to the management~     protocol published in a NICE guideline.~   "
8023|NCT03461822|"~     The purpose of this study is to development of more effective treatment tactics of the~     stereotactic radiotherapy and radiosurgery alone and together with classic radiation therapy~     in primary inoperabel solid tumors and oligometastastatic cancer.~   "
8024|NCT03461809|"~     This retrospective observational study is designed to assess the response to treatment with~     ocular acupuncture and its relative factors, in terms of diplopia status, ocular motility~     differences, and clinical features, in ocular motor nerve palsy patients. During this study,~     a retrospective data collection will be carried out using the information contained in the~     medical record of aimed patients, provided that the treatment with ocular acupuncture.~   "
8025|NCT03461783|"~     The purpose of this randomized, prospective study is to evaluate how this activated carbon~     dressing affects the total bacterial load and biofilm in a wound bed in wounds of the lower~     extremity and foot. We anticipate that the use of Zorflex® Activated Carbon Cloth dressing~     will maintain the bacterial burden in the wound bed below the level of critical colonization,~     with potential secondary benefits of pain reduction, decrease in inflammation, and control of~     odor. Wound bed healing progression/acceleration also will be assessed.~   "
8026|NCT03461770|"~     Anesthesia-induced atelectasis is a well-known entity observed in approximately 68-100% of~     pediatric patients undergoing general anesthesia. Infants and young children are more~     susceptible to this lung collapse due to their small functional residual capacity. Thus,~     intrapulmonary shunting caused by those atelectasis are more likely to occur during general~     anesthesia in infants and younger children than in adults. This problem predisposes children~     to hypoxemic episodes that can persist in the early postoperative period. Beyond the negative~     impact of atelectasis on gas exchange, mechanical ventilation induces a local inflammatory~     response in atelectatic lungs, even in healthy patients undergoing general anesthesia.~      Therefore, the diagnosis, prevention and active treatment of anesthesia-induced atelectasis~     are mandatory, not only to avoid hypoxemic episodes and atelectasis-related post-operative~     pulmonary complications, but also to protect the lungs during mechanical ventilation.~     Nowadays, the diagnosis of anesthesia-induced atelectasis is easily and accurately~     accomplished by lung ultrasound (LUS). LUS is a simple and non-invasive tool useful to detect~     atelectasis in children, to assess lung aeration and for monitoring ventilator settings or~     strategies. Regarding to the prevention of atelectasis, it was demonstrated that the~     application of continuous positive airway pressure (CPAP) during the induction of general~     anesthesia decreases atelectasis formation in adult morbidly obese patients.~      The investogators hypothesized that the use of CPAP during general anesthesia induction in~     pediatric patients can prevent or decrease atelectasis formation.~   "
8027|NCT03461757|"~     The purpose of this study is to compare the efficacy of BHV-3000 (rimegepant ODT) versus~     placebo in subjects with Acute Migraines.~   "
8028|NCT03461744|"~     It is difficult to predict which patients with acute small bowel obstruction require~     operative intervention and which ones can be handled conservatively. Similarly, strangulation~     remains difficult decision. The rationale for this observative study is to collect~     prospective cohort of patients with small bowel obstruction to create scoring system to~     predict early 1) small bowel obstruction resistant to conservative therapy, 2) strangulation.~   "
8029|NCT03461731|"~     800-nm laser light has been shown to delay muscle fatigue when applied before exercise. The~     effect of illumination during the aerobic phase of strenuous exercise has not been studied.~     The investigators hypothesize that the increased energy donated to cells during the aerobic~     phase will significantly delay muscle fatigue. A novel aspect of this study is to include~     simultaneous treatment with near infrared light at 800 nm and 905 nm. Fatigue index and~     change in lactate blood level will be used to compare the different laser treatments for each~     participant. Monte Carlo simulations of light energy reaching the muscle will be carried out,~     based on skin-fold thickness measurements of each participant. The investigators believe this~     will be the first report of optical dosimetry as a function of adipose thickness and it will~     enable estimation how much of the light applied to the skin surface is able to penetrate to~     the muscles that are thought to be affected. The results of this study will help clinicians~     to optimize treatment for individual patients.~   "
8030|NCT03461718|"~     We will be investigating the use of ketamine in sedation for endoscopic procedures,~     specifically outpatient endoscopy including esophagoduodenoscopy (EGD) and colonoscopy.~     Participants will be randomized to one of two arms including conventional moderate sedation~     with midazolam and fentanyl or the ketamine arm. They will then undergo the planned~     procedure. Physicians preforming the procedure will be surveyed following the procedure and~     patients will be surveyed twice, once after meeting criteria for discharge on day of the~     procedure and a second time 48 hours following the procedure.~   "
8031|NCT03461705|"~     This study will enroll patients who are referred for coronary angiography and require~     physiological assessment to see if the lesion can be treated as per the local standard of~     care. Approximately 92 participants will be enrolled. There are no follow up visits required~     so participation in this study will end when subjects are discharged from the hospital.The~     study will be comparing the resting flow reserve against the instantaneous wave-free ratio~     (iFR) and fractional flow reserve. All these tests offer a way to image a legion and~     determine if it is suitable to be treated. FFR measures the pressure differences across~     (narrowed coronary arteries usually due to atherosclerosis), iFR's are performed during~     cardiac catheterisation (angiography) using invasive coronary pressure wires which are placed~     in the arteries of the heart that are to be assessed and the Resting flow reserve looks at~     the maximum increase in blood flow through the coronary arteries above the normal resting~     volume.~   "
8032|NCT03461692|"~     This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy~     of Chinese Medical Sciences in February 2018.~      The purpose of this study is to make a monitoring of adverse reactions in 100 thousand~     children aged 14 years and below to see whether Reduning injection is safe and the~     characteristic and mechanism of anaphylactic reaction used Reduning injection in hospitals in~     China.~   "
8033|NCT03461679|"~     The aim of the study is to investigate whether the addition of an adductor canal block to a~     femoral triangle block will provide better analgesia for patients after total knee~     replacements.~   "
8034|NCT03461666|"~     This study compares the efficacy of four different types (Cognitive Behavior Therapy for~     Insomnia (CBT-I); Focus of Attention (FOA); Combined CBT-I and FOA; and Sleep Hygiene~     (control group) for the treatment of insomnia. This study is a randomized, open label study,~     and the participants are asked to assess the benefits they get from the intervention. This~     study involve 6 weekly in person one-to-one sessions after screening and completion of the~     1-week, 3-month, 6-month and 12-month follow-up assessment. The trained study staff will~     administering the treatment. The Research Department will administer the outcome measures.~     The review of insomnia improvement will be assessed at at end of treatment, 3 months, 6~     months and 12 months follow-up.~   "
8103|NCT03460769|"~     The Coordinating and Data Management Center (CDMC) at MD Anderson Cancer will be responsible~     for the coordination and data management for the Evaluation of a mixed meal test for~     Diagnosis and characterization of Type 3c diabetes mellitus secondary to pancreatic cancer~     and chronic pancreatitis (DETECT), which is part of the NIH U01 funded Consortium for the~     Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC). Similar to all~     studies that will be coordinated and managed by the CDMC, no patient enrollment will occur at~     MDACC. All patient recruitment will occur at external sites that are a part of the CPDPC,~     which are listed in the appended DETECT protocol. The data management systems, auditing, and~     monitoring effort are supported by the CDMC.~   "
8036|NCT03461640|"~     One initiative to address communication problems between migrant women not fluent in Swedish~     and caregivers throughout childbirth is to provide language assistance, cultural~     interpretation and labour support to the woman through Community Based Doulas (CBDs). CBDs~     are bilingual women from migrant communities trained by midwives to provide cultural,~     language and labour support to migrant women throughout their labour and birth.~      The study will evaluate the effectiveness of community-based doula support for improving the~     intrapartum care experiences and postnatal wellbeing of Somali-, Tigrinya -, Arabic- and~     Russian-speaking migrant women giving birth in Stockholm, Sweden.~      The randomisation ratio will be 1:1; CBD support in addition to standard intrapartum care or~     standard intrapartum care. Women allocated to receive CBD support in addition to standard~     intrapartum care (intervention group), will be contacted by a Somali, Arabic-, Russian- or~     Tigrinya-speaking CBD as appropriate, and arrangements will be made for the doula and the~     women to meet twice prior to the birth to get to know each other and discuss the woman's~     wishes regarding support in labour and what the CBD can offer. Each woman will then contact~     her CBD when she goes into labour and the CBD will attend hospital with her and stay with her~     throughout labour and birth, in addition to any other support people she may have, such as~     her partner. Women allocated to the comparison arm of the trial will receive standard~     intrapartum care as provided at their chosen hospital of birth.~      The hypothesis is that women randomised to receive CBD support in labour will rate their care~     for labour and birth more highly and have better emotional wellbeing (lower mean scores on~     the Edinburgh Postnatal Depression Scale) two months after birth than women allocated to~     standard care.~   "
8037|NCT03461627|"~     assess the efficacy and safety of Salmeterol Xinafoate and Fluticasone Propinate Powder for~     inhalation (50ug/250ug) in combination with seretide to patients with Asthma.~      a randomized, double-blind, double-dummy, positive-controlled, parallel-group trail.~   "
8038|NCT03461614|"~     In recent years adolescent substance abuse is a serious and growing problem. Substance use~     among adolescents means the use of alcohol, opiates, amphetamines, inhalants, cocaine,~     marijuana, benzodiazepines, hallucinogens, and anabolic steroids. The United Nations Office~     on Drugs and Crime reports that approximately 5% of the world's population used an illicit~     drug in 2010 and it is estimated that heroin, cocaine and other drugs are responsible for 0.1~     to 0.2 million deaths per year.~      There is a limited number of studies in the literature that investigate the relationship~     between substance use disorder and respiratory functions. In Taylor et al., study reported~     that the proportion of cannabis-dependent study members with an FEV1/FVC ratio of, 80% was~     36% compared to 20% for non-smokers. Another research of Taylor et al., in longitudinal~     observations over 8 years in young adults (cannabis smoking on lung function in young adults~     between the ages of 18 and 26) revealed a dose-dependent relationship between cumulative~     cannabis consumption and decline in FEV1/VC. In a monograph, stated that follow-up studies of~     regular cannabis-only smokers also found impaired respiratory function and pathological~     changes in lung tissue like those preceding the development of chronic obstructive pulmonary~     disease .~      The core anatomically described as a box, with the abdominals at the front, spinal and~     gluteal muscles at the back, the diaphragm on the top, and the pelvic floor and hip muscles~     on the bottom. Correct breathing is vital to abdominal training because respiratory muscles~     are directly involved during common core stability exercises. Moreover, the diaphragm, a~     component of core stability, plays a role in respiration and trunk stability by controlling~     intra-abdominal pressure . Oh et al.reported that, 30-min, 3 days a week for 8 weeks lumbar~     stabilization exercise had a more positive effect on pulmonary function than general physical~     therapy on stroke patients.~      Our hypothesis was that core exercises may positive effect on respiratory functions and~     functional capacity of substance use disorder individuals. The aim of our study is to~     investigate the effects of core exercises on respiratory functions and functional capacity in~     adolescents with substance use disorder.~   "
8039|NCT03461601|"~     A prospective randomized study included 210 women with Unexplained infertility subjected to~     combined ovarian stimulation and Intrauterine insemination (IUI). Two equal groups. Study~     group, subjected to uterine flushing with Human chorionic gonadotropin (HCG) one day before~     IUI and control group subjected to IUI alone.~   "
8040|NCT03461588|"~     This study is to prospectively investigate the cardiac dose-sparing effect and clinical~     benefit of deep inspiration breath-hold (DIBH) technique. Patients with left-sided breast~     cancer treated with breast conserving surgery followed by radiotherapy is enrolled.~     Radiotherapy is delivered with either free-breathing or deep inspiration breath-hold (DIBH)~     technique. The cardiac dose parameters and cardiac toxicity are prospective evaluated, and~     the dose-effect relationship is analyzed.~   "
8041|NCT03461575|"~     A multicenter, Randomized, Double blind, Restasis®-controlled Non-inferiority, Moisview® Eye~     Drops-controlled Superiority, Phase III Study to Evaluate the Efficacy and Safety of HU007~     Eye Drops in Patients with Dry Eye Syndrome~   "
8042|NCT03461562|"~     Purpose of the study will investigate the effects of two different training programs on~     hepatic steatosis and physical fitness parameters. This trial is designed in a randomized~     controlled study plan and aerobic training (40 minutes) wil be combined with Whole Body~     Vibration Training (WBVT for 15 minutes) which is made up of a shorter time application. WBVT~     to be applied instead of the resistance exercises.~   "
8043|NCT03461549|"~     Pilot study of a soft, flexible pressure and temperature sensor~   "
8044|NCT03461536|"~     This is a randomized trial to determine the effect of a clinical decision support tool on~     image ordering for patients with suspected nephrolithiasis. Patients who present with acute~     unilateral flank or abdominal pain in whom emergency department providers suspect~     nephrolithiasis will receive either a clinical decision support module or no module.~   "
8045|NCT03461523|"~     The purpose of the study is to evaluate the hypothesis of poor clinical outcomes in~     critically ill patients that are having abnormal BMI.~   "
8046|NCT03461510|"~     This study evaluates differences in brain function and cognitive performance in adolescents~     with type 2 diabetes (T2D) compared to non diabetic controls (both obese and lean) and~     correlates these changes with obesity, insulin resistance, and glycemic control in youth with~     T2D.~   "
8101|NCT03460795|"~     Fibrosis of the liver is excessive accumulation of scar tissue that results from ongoing~     inflammation and liver cell death that occurs in most types of chronic liver diseases.~     Nodules, abnormal spherical areas of cells, form as dying liver cells are replaced by~     regenerating cells. This regeneration of cells causes the liver to become hard. Fibrosis~     refers to the accumulation of tough, fibrous scar tissue in the liver. The potential for stem~     cells to differentiate into hepatocytes cells was recently confirmed. Particularly,~     mesenchymal stem cell (MSC) has been demonstrated to decrease model for end-stage liver~     disease (MELD) score and increase serum albumin in liver injury patients. Therefore, the~     investigators propose a hypothesis that MSCs can also improve the disease conditions of liver~     fibrosis patients, particularly reducing the decompensated conditions in these patients.~   "
8047|NCT03461497|"~     As surgery enters the era of value-based care, it is advocated that postoperative recovery be~     measured using patient-reported outcomes (PROs) as they provide a mean to incorporate the~     patient's perspectives and experiences into research and clinical decision-making. In~     abdominal surgery, this is currently precluded by the lack of PRO measures specifically~     developed and validated in the context of postoperative recovery.~      The core goal of this research project is to develop a PRO measure aimed to assess~     postoperative recovery from the perspective of patients undergoing abdominal surgery. This~     project complies with the US Food and Drug Administration (FDA) and International Society for~     Pharmacoeconomics and Outcomes Research (ISPOR) guidelines for PRO development and will be~     conducted in three phases:~      Phase 1: Qualitative interviews with patients to develop a conceptual framework and generate~     relevant items.~      Phase 2: Use of Rasch Analysis for item-reduction and scale formation.~      Phase 3: Further assessment of measurement properties based on traditional psychometric~     methods.~   "
8048|NCT03461484|"~     Prospective, multi-center observational study to be conducted in up to 30 French~     interventional cardiology centers. The purpose of this observational study is to capture, in~     French Centers, clinical data of the BioMatrix Flex™ and BioMatrix NeoFlex™ Drug Eluting~     Coronary Stents System (Biolimus A9, BA9™-) in normal practice, in patients treated with~     6-month DAPT, and to compare the outcomes to those of previous e-biomatrix registries with~     longer DAPT durations. The patients will be followed up for 2 years for data collection.~   "
8049|NCT03461471|"~     Exercise in all Chemotherapy (EnACT) is a study to assess safety, feasibility, and~     acceptability of an exercise program within chemotherapy. This will be a single group study~     to capture the effects of an exercise intervention on the average chemotherapy patient and~     the patients compliance to the study.~   "
8050|NCT03461458|"~     To determine the safety and feasibility of autologous, culture-expanded adipose-derived (AD)~     mesenchymal stromal cells (MSCs) in subjects with painful degenerative disc disease (DDD).~   "
8051|NCT03461445|"~     Previous studies have shown that elderly patients experience higher trough levels of~     tacrolimus and are more sensitive to the effects of medications, they experience higher~     occurrence and severity of such medication related toxicities. Therefore, the investigators~     hypothesize that by transitioning patients from tacrolimus immediate release to Envarsus ®,~     the peak-dose effect will be eliminated or attenuated, leading to a significant decrease in~     neurocognitive toxicities in the older patient population.~   "
8052|NCT03461432|"~     Cognitive deficits have been shown to have negative impact on social functioning and~     functional goals such as ability to work and perform daily tasks in people with~     schizophrenia. There is evidence that Cognitive Remediation Therapy, a form of psychological~     therapy, is effective in improving cognition and functioning but there is still a limited~     understanding of what influence people's different response to this therapy. A tailored~     treatment is likely to be more effective because it will adapt to service users' unique~     characteristics.~      The investigators are planning a study exploring at the feasibility and acceptability of~     novel form of Cognitive Remediation Therapy which is personalised (pCRT) to the person~     individual characteristics. The personalised therapy will consist of task practice using~     computerized Cognitive Remediation software (i.e. called CIRCuiTS). The knowledge gathered in~     this work will contribute to develop the next generation of personalised treatment approaches~     for people with schizophrenia.~   "
8053|NCT03461419|"~     Purpose of study is to determine safety and efficacy of use of autologous Adipose-Derived~     cellular Stromal Vascular Fraction (AD-cSVF) suspended in Normal Saline and delivered via~     intravascular system of quality of life and alteration of documented Advanced Muscular~     Sclerosis (MS). It is believed that the heterogeneous cell population which includes~     multipotent stem/stromal cells plus non-multipotent cellular elements are capable of immune~     modulation/inflammatory modulation properties. Exam of disease progression and quality of~     life changes will be evaluated by sophisticated mathematical non-biased MRI analysis.~   "
8054|NCT03461406|"~     This is a prospective, randomized, active-controlled, single-blind, parallel group clinical~     trial to evaluate the safety and efficacy of FS Grifols as an adjunct to hemostasis during~     surgery in pediatric subjects.~      Pediatric subjects (<18 years of age) requiring an elective (non-emergent), open~     (non-laparoscopic), pelvic, abdominal, or thoracic (non-cardiac) surgical procedure, wherein~     a target bleeding site (TBS) is identified, and a topical hemostatic agent is indicated, will~     be eligible to participate in the clinical trial.~      The study treatments will be applied on the cut parenchymous surface of a solid organ (ie,~     liver) and in soft tissue (ie, fat, muscle, or connective tissue).~   "
8055|NCT03461393|"~     Data collection and observation of changes within AMD patients performing visual training on~     mobile devices~   "
8056|NCT03461380|"~     This study compares the efficacy of a fixed combination of black cohosh (EP-40) and Rhodiola~     rosea (EPR-7) with low (6.5 mg) and high doses (500 mg) of a standardized black cohosh~     extract only in adult woman with menopausal complaints.~   "
8057|NCT03461367|"~     To evaluate the long-term outcome of chronic total occlusion (CTO) patients underwent~     contemporary percutaneous coronary intervention (PCI) techniques, we design this~     single-center, large-sample, prospective registry with five-year clinical follow-up, based on~     the intravascular ultrasound (IVUS) finding.~   "
8058|NCT03461354|"~     This study will examine if the administration of prophylactic MucoLox formulation versus~     sodium bicarbonate mouthwash in subjects with head/neck cancer receiving radiation ±~     chemotherapy will result in significantly fewer subjects experiencing severe mucositis.~   "
8059|NCT03461341|"~     The ENSURE study will comprise two phases.~      Phase 1: European multicenter survey of surveillance protocols after esophageal cancer~     surgery~      ENSURE questionnaire will be circulated to representatives from participating European~     countries.~      Phase 2: European multicenter retrospective observational study of the impact of~     postoperative surveillance protocols on oncologic outcome and HR-QL~      Phase 2 will constitute a retrospective observational study of patients undergoing treatment~     with curative intent for esophageal cancer at participating Centers from June 2009 to June~     2015.~   "
8102|NCT03460782|"~     IPILIMUMAB Extended Access Program for patients who received chemotherapy and / or radiation~     therapy before the protocol, before or after the operation.~   "
8104|NCT03460756|"~     A clinical study to evaluate safety, tolerability and efficacy of oral administration of~     ganaxolone in women with postpartum depression~   "
8060|NCT03461328|"~     Chronic Obstructive Pulmonary Disease [COPD] is a major cause of chronic morbidity and~     mortality worldwide. COPD is characterized by persistent progressive airflow limitation that~     adversely affects the ventilation/perfusion (V/Q) matching and mechanics of the respiratory~     muscles and leads to hypoventilation and reduced gas transfer. COPD was identified as a~     significant comorbidity associated with increased incidences of postoperative pulmonary~     complications and prolonged hospital stay. MgSO4 either intravenous or inhalational has been~     shown to promote bronchodilation and to improve lung function in asthmatic patients. MgSO4~     either intravenous or inhalational has been shown to promote bronchodilation and to improve~     lung function in asthmatic patients. Administration of MgSO4 in patients with stable COPD was~     associated with reduced lung hyperinflation and improvement of respiratory muscle strength.~     This randomized control trial is designed to assess the effect of intravenous MgSO4 infusion~     on oxygenation and pulmonary mechanics and incidence of postoperative pulmonary complications~     and length of hospital stay in patients with COPD undergoing cancer larynx surgery.~   "
8061|NCT03461315|"~     Home care is the assistance provided at home to those who can not travel to their Health~     Center. There are multiple studies on models of home care and many discrepancies about the~     impact that preventive home visits can have. Hypothesis: home care is expected to be better~     if performed by a team dedicated exclusively to the home patient, than to the traditional~     model, where the patient is assisted by the team that cares for the rest of the community.~      Goals:~      Main: determine the difference in median cumulative days of hospital admission in 12 months.~      Secondaries:~        -  results in health~        -  in health experience in efficiency Methodology: Quasi-experimental study of two years~          duration. All the subjects included in the Home Care Program and that meet the inclusion~          and exclusion criteria are studied. The care team will provide the informed consent and~          information sheet to the patient and clinical scales at the beginning and end of the~          study. Researchers will be responsible for the collection of data that they will~          anonymize and guard. Statistical analysis: The analyzes will be calculated with the~          statistical package SPSS version 21 Expected results: hospital admissions (25%) and~          cumulative days by admission and patient by 65% are expected to improve in the model~          under study. Applicability and relevance: the trend towards a greater aging of the~          population makes it necessary to study models of care that allow us to detect which can~          be beneficial to the population and feasible in our current context.~   "
8062|NCT03461302|"~     Rationale/hypothesis: Atopic dermatitis (AD) is an inflammatory skin disease, occurring most~     frequently in children. Currently, topically applied corticosteroids are used as a standard~     anti-inflammatory treatment. When a corticosteroid with a high potency is used for a long~     period of time, adverse effects like skin atrophy and systemic effects may occur, especially~     in children. In addition, corticophobia among patients is an issue that warrants alternatives~     for the treatment of AD in children. An alternative treatment is the topical application of~     coal tar, which is known to be an effective and safe treatment for AD for ages, and is used~     in our department for decennia. Although there is convincing evidence in the literature on~     the safety of coal tar, evidence in the literature on the efficacy of coal tar in the~     treatment of AD is lacking, especially in children.~      Objective: To evaluate efficacy of topical treatment with coal tar compared to topical~     treatment with corticosteroids in children aged 1 to <16 years with moderate to severe AD~      Study design: investigator-initiated, parallel-group randomized controlled pilot study~      Study population: Children aged 1 to <16 years with moderate-severe AD~      Intervention: Patients will be randomized in two groups: (1) topical treatment with coal tar~     or (2) topical treatment with moderate potency corticosteroids for a treatment duration of 4~     weeks.~      Main study parameters/endpoints: The primary outcome is the percentage change in EASI score~     at week 2.~   "
8063|NCT03461289|"~     Phase 3, open-label, single-arm, single-dose, trial of AVXS-101 (gene replacement therapy) in~     patients with spinal muscular atrophy (SMA) Type 1 who meet enrollment criteria and are~     genetically defined by a biallelic pathogenic mutation of the survival motor neuron 1 gene~     (SMN1) with one or two copies of survival motor neuron 2 gene (SMN2). Up to 30 patients < 6~     months (< 180 days) of age at the time of gene replacement therapy (Day 1) will be enrolled.~   "
8064|NCT03461276|"~     Alzheimer's disease (AD) is the most common type of dementia, accounting for 50-75% of the~     estimated 47 million people with dementia worldwide. The amyloid cascade hypothesis of AD~     proposes that amyloid-β (Aβ) peptide accumulation in the brain, caused by an imbalance~     between Aβ production and clearance, is the initiating factor of a cascade ultimately leading~     to dementia.~      Aβ peptides are generated from sequential cleavage of the amyloid precursor protein (APP),~     including Aβ40 and Aβ42. Aβ40 is the predominant variant (90%) among the secreted Aβ forms~     and although Aβ42 is more hydrophobic and prone to aggregate, and Aβ42 oligomers are regarded~     to be the most neurotoxic species, Aβ40 can also produce highly toxic diffusible aggregates,~     which can be prevented in vitro by specific anti-Aβ40 antibodies.~      Several studies have proposed that a high concentration of Aβ40 in the brain distinguishes~     patients with AD from those who have senile plaques but are cognitively normal, pointing to~     the importance of Aβ40 in the onset of dementia. In keeping with this, previous studies have~     demonstrated that specific anti-Aβ40 antibodies label NFTs in the entorhinal cortex and the~     hippocampus of AD brains, and that these do not co-localize with tau NFTs, suggesting the~     presence of degenerating neuronal populations filled with C-terminal fragments of Aβx-40. In~     addition, Aβ40 is the main component of amyloid deposition around cerebral arteries causing~     cerebral amyloid angiopathy (CAA), which has a prevalence of about 80-90% in patients with AD~     (for more information see Lacosta et al. Alzheimer's Research & Therapy (2018) 10:12 DOI~     10.1186/s13195-018-0340-8).~      Considering those previous results suggesting that strategies targeting Aβ40 could represent~     novel disease-modifying therapies, we have developed ABvac40, the first active vaccine~     targeting the C-terminal end of the Aβ40 peptide.~      The purpose of this Phase II study is to confirm in patients with a-MCI or vm-AD the level of~     safety and tolerability obtained in the ABvac40 Phase I clinical trial in patients with~     mm-AD. In addition, the study is aimed to better characterize the immune response elicited by~     ABvac40 and to explore its effects on AD biomarkers.~   "
8065|NCT03461263|"~     It has been observed that out of all visits to the clinics by the young and middle age men~     for grievances including the genital and urinary frameworks, about 25% of the visits account~     for Prostatitis. A significant number of men, aged less than 50, visits to urologist due to~     Interminable prostatitis. Nevertheless, just 5 to10% of prostatitis cases is really caused~     by a bacterial contamination.~      The purpose was to investigate thoroughly the effect of pumpkin seeds oil phonophoresis among~     males who are diagnosed with chronic non-bacterial prostatitis.~   "
8257|NCT03458767|"~     Development and pilot testing of a cognitive self-management intervention for persons with~     multiple sclerosis (PwMS) emphasizing physical activity (PA) delivered via web-based video~     conference.~   "
48677|NCT02929797|"~     A Prospective Study on the Efficacy and Safety of CD8+NKG2D+ AKT cell immunotherapy to the~     pancreatic cancer patients treated with adjuvant chemotherapy.~   "
8066|NCT03461250|"~     This is an observational study of cases of chronic hepatitis C and negative HCV controls in~     adults receiving chronic hemodialysis at the National Renal Health Center (NRHC) -EsSalud in~     Lima - Peru.The NRHC provides specialized health care, including hemodialysis, to people with~     advanced kidney disease from all the districts of Lima.~      Study population: By December 2017, there were 293 adults receiving chronic hemodialysis at~     the NRHC-EsSalud.~      All adult patients receiving chronic hemodialysis at the NRHC-EsSalud will be invited to~     participate.~      Primary objective: Characterize HCV disease in patients receiving chronic hemodialysis at the~     NRHC-EsSalud.~      Secondary objective: Identify factors associated with an increased risk of HCV infection.~      Inclusion criteria:~      Age > 18 years Receive chronic hemodialysis (for at least 6 consecutive months) at the NRHC.~      Exclusion criteria:~      • Inability to provide informed consent. To comply with the primary objective of the study,~     samples from volunteers with HCV serology confirmed in Roe Clinic Laboratory (cases) will be~     subjected to additional tests: HCV viral load followed by determination of the HCV genotype~     by using the Abbott m2000 real-time PCR system capable of identifying genotypes 1 (1a and~     1b), 2, 3, 4 , 5 and 6, using fluorescent probes of oligonucleotides specific for each~     genotype .~      In addition to these lab tests, volunteers will have a Fibroscan test performed at a local~     provider, with the Fibroscan Model 402 with E and XL probes.~      The information will be collected in a Case Report Form (CRF), which will be filled out by~     study staff. The source of clinical information will be primarily the clinical history of the~     NRHC - EsSalud. The source of information on the results of the auxiliary tests will be~     obtained from the results issued by Roe Clinic Laboratory and by the image center of the~     Delgado Clínic.~      Protection of Human Subjects:~      The protocol and informed consent will be reviewed and approved by the Ethics Committee of~     the NRHC. No study procedure will be carried out if the volunteer has not given his or her~     written consent. All reasonable precautions will be taken to protect the privacy of the~     volunteer's information, whose data will be identified only through a code. Researchers will~     keep the study folders in a locked cabinet in a safe place~   "
8067|NCT03461237|"~     1. To Compare overall rates of second hip fractures in both genders,~        2. To determine the effect of hip fracture on proximal femoral volumetric bone mineral~          density (vBMD), bone structure and muscle by quantitative computed tomography(QCT),~        3. To evaluate the contribution of QCT-image analysis to the prediction of the second hip~          fracture risk.~        4. To identify the differences between femoral neck fracture and trochanter fracture~          following hip fracture~   "
8068|NCT03461224|"~     This trial was a retrospective study on postoperative accelerated hypofractionated IMRT~     (MARA-1) in patients with early stage breast carcinoma, to compare late toxicity after this~     treatment and standard fractionated RT delivered with 3D-CRT.~   "
8069|NCT03461211|"~     The overall objective is to evaluate the safety and efficacy of teprotumumab in the treatment~     of Thyroid Eye Disease (TED) in participants who participated in the lead-in study~     HZNP-TEP-301 (NCT03298867) and who were either proptosis non-responders at Week 24 of~     HZNP-TEP-301 or were proptosis responders at Week 24 but meet the criteria for re-treatment~     due to relapse during the Follow-Up Period of HZNP-TEP-301.~   "
8070|NCT03461198|"~     The objective of this study is to determine the efficacy and safety of Restylane® Silk~     microinjections when used in a grid-like injection pattern for the correction of fine lines~     to the cheeks.~   "
8071|NCT03461185|"~     Epidermal growth factor receptor Tyrosine kinase inhibitor (EGFR TKI) have been approved to~     treat NSCLC harboring EGFR mutation as first-line therapy. However, the acquired resistance~     of EGFR-TKI is a common and severe problem.The study explore the superiority of~     anti-angiogenesis drugs (Apatinib, endostatin, anlotinib) plus EGFR TKI versus single~     EGFR-TKI.~   "
8072|NCT03461172|"~     For several years, the Paoli-Calmettes Institute has been centralizing the retrospective~     collection of clinical data of patients operated on for histologically proven breast cancer.~   "
8073|NCT03461159|"~     Emerging evidence demonstrates that animals and people can exert control over the level of~     excitability in spinal and corticospinal neural circuits that contribute to movement. This~     discovery has important implications, as it represents a new strategy to improve motor~     control in people of all ability levels, including those with neurological conditions.~     Operant conditioning is a well-studied mechanism of learning, in which the modification of a~     behavior can be brought about by the consequence of the behavior, and reinforcement causes~     behaviors to become more frequent. In recent years, operant conditioning has been applied to~     spinally-mediated reflex responses in mice, rats, monkeys and people. By electrically~     stimulating a peripheral nerve, recording the muscle response, and rewarding responses that~     are within a desirable range, it is possible to increase or decrease the neural circuit's~     excitability. This may alter the level of resting muscle tone and spasticity, as well the~     muscle's contribution to planned movements and responses to unexpected events. Operant~     conditioning of spinal reflexes has been applied to a lower limb muscle in healthy people and~     those with spinal cord injuries. In this project, we will expand the use of operant~     conditioning to muscles of the upper limb, demonstrating feasibility and efficacy in healthy~     people and people post-stroke. We will determine whether operant conditioning can be used to~     decrease excitability of spinal reflexes that activate a wrist flexor muscle. Additionally,~     in a separate group of healthy people, we will determine whether operant conditioning can be~     used in a similar way to increase corticospinal excitability. We will stimulate the motor~     cortex with transcranial magnetic stimulation to elicit motor evoked potentials in the same~     wrist flexor muscle, and will reward responses that exceed a threshold value. We will examine~     the effects of these interventions on motor control at the wrist, using an innovative~     custom-designed cursor-tracking task to quantify movement performance. We will determine~     whether changes in spinal reflex excitability or corticospinal excitability alter motor~     control. The overall goal of this research is to develop a new, evidence-based strategy for~     rehabilitation that will improve recovery of upper limb function in people after stroke.~   "
8074|NCT03461146|"~     For hemodialysis subjects not receiving ESAs with anemia associated with chronic kidney~     disease, evaluate Hb correction and maintenance effect and safety of MT-6548.~   "
8075|NCT03461133|"~     Establishment of early warning systems in hospitals was strongly recommended in recent~     guidelines to detect deteriorating patients early and direct them to adequate care. Upon~     meeting of predefined trigger criteria Medical Emergency Teams (MET) should be directed to~     these patients. The present study analyses the effect of introduction of an automated early~     warning and trigger system on two peripheral wards hosting a highly complex surgical patient~     cohort.~   "
8076|NCT03461120|"~     When a limb is amputated, pain perceived in the part of the body that no longer exists often~     develops, called phantom limb pain. The exact reason that phantom limb pain occurs is~     unclear, but when a nerve is cut-as happens with an amputation-changes occur in the brain and~     spinal cord that are associated with persistent pain. The negative feedback-loop between the~     injured limb and the brain can be stopped by putting local anesthetic-called a nerve~     block-on the injured nerve, effectively keeping any bad signals from reaching the brain. A~     continuous peripheral nerve block (CPNB) is a technique providing pain relief that involves~     inserting a tiny tube-smaller than a piece of spaghetti-through the skin and next to the~     target nerve. Local anesthetic is then introduced through the tiny tube, which bathes the~     nerve in the numbing medicine. This provides a multiple-day block that provides opioid-free~     pain control with no systemic side effects, and may prevent the destructive feedback loop~     that results in phantom limb pain following an amputation. We propose a multicenter,~     randomized, triple-masked (investigators, subjects, statisticians), placebo-controlled,~     parallel arm, human-subjects clinical trial to determine if a prolonged, high-concentration~     (dense), perioperative CPNB improves post-amputation physical and emotional functioning while~     decreasing opioid consumption, primarily by preventing chronic phantom limb pain.~   "
8077|NCT03461107|"~     The purpose of this study is to evaluate the beta-adrenergic receptor gene polymorphisms in~     the long-term effects of beta-blockade in patients with chronic heart failure.~   "
8078|NCT03461094|"~     Fluid therapy is often used as first line treatment of acute circulatory failure, aiming an~     increase in cardiac output (by improving preload) and in tissue perfusion. Depending on left~     ventricular systolic function, fluid challenge could lead to an increase in cardiac ouput and~     tissue perfusion, or only detrimental consequences (by fluid overload and aggravation of lung~     and tissues oedema, increase of morbi-mortality). Patients are defined as responders to fluid~     therapy if one can observe an increase of cardiac output up to 15% after fluid therapy (500ml~     of crystalloids): gold standard test used in most of the studies on the subject. Literature~     reports on heterogenous populations a reproductible and constant response rate to this fluid~     challenge of 50%. It seems reasonable to dispose of indices allowing to predict fluid~     responsiveness without resulting in fluid intake. Statics markers have been abandonned for~     several years and dynamics methods have been developped.~      In front of arrythmia, validated methods are scarce. Passive leg rising method appears to be~     the only one and it's validity seems to be less well documented than in sinusal patients. The~     purpose of this study is to determine a new method to assess fluid responsiveness in~     arrythmic patients.~      In atrial fibrillation, RR interval varies widely between cardiac cylces. Systolic interval~     remain constant. Variations will occure at expense of diastolic interval, or ventricular~     filling interval. One can reliably assume that when RR is longer, preload is rising. If the~     patient is on the ascendant part of the Franck-Starling curve, a longer RR should cause au~     greater VTI (Vitess Time Integral, surrogate of cardiac output).~      The evaluation by transthoracic echocardiography of the indice delta ITV / delta RR should~     determine the degree of fluid responsiveness in arrhythmic patients.~      After decision of fluid expansion, patients will have haemodynamic and echocardiographic data~     measured, delta ITV / delta RR indice assessed, then passive leg rising and fluid expansion~     with 500 ml of cristalloids administered, with evaluation of VTI (as surrogate of cardiac~     output) at each time. Fluid responders will be compared to non-responders to evaluate the~     diagnostic performances of the indice delta ITV / delta RR.~   "
8079|NCT03461081|"~     study to evaluate drug-drug interaction following oral administration of~     telmisartan/amlodipine and atorvastatin in healthy adult volunteers~   "
8080|NCT03461068|"~     The ketone body beta-hydroxybutyrate is produced during prolonged fasting or when endogenous~     carbohydrate stores are depleted and can be used as an alternative fuel source. Exogenous~     beta-hydroxybutyrate, in the form of a ketone monoester, is proposed to have glucose-lowering~     potential but this has not been adequately studied. The purpose of this study is to determine~     whether supplementing with an acute dose of ketone monoester can improve the glycemic~     response to an oral glucose tolerance test in individuals with impaired fasting glucose.~   "
8081|NCT03461055|"~     The Researchers hope to learn if by using lavender aromatherapy during an intrauterine~     insemination patients have decreased anxiety and pain at the time of the procedure.~   "
8082|NCT03461042|"~     To investigate effects on combination use of Ramelteon in the dose reduction or interruption~     process of (non-)BZD hypnotics during the dose reduction or interruption algorithm.~   "
8083|NCT03461029|"~     The aim of the study is to establish and identify the level of sedation that is performed in~     the endoscopy rooms of Galdakao Hospital. To do this, the investigators used the BIS~     monitoring system, which obtains objective values in real time from the anesthesia performed.~     The monitoring is completed with basic parameters validated by European guidelines (heart~     rate, blood pressure, oxygen saturation and respiratory rate), capnography and Ramsay~     sedation scale, widely validated for use outside the operating room. The main work hypothesis~     was that in at least 10% of the patients BIS values compatible with moderate or deep sedation~     would be obtained (BIS <65).~   "
8084|NCT03461016|"~     Exposure therapy, including its self-directed forms, is effective for treatment of specific~     phobias. Nevertheless, there are issues with patient adherence in the use of exposure~     therapy, including its self-directed formats. Technological advancements, as with~     smartphones, may improve adherence to self-directed exposure therapy, perhaps due to exposure~     stimuli being more readily accessible. Thus, there is a need to examine how presenting phobic~     material on a smartphone might promote increased adherence in conducting self-directed~     exposure. Additionally, exposure can incorporate phobic material from different perspectives~     (i.e., first-person or third-person), which is one factor that may impact treatment~     effectiveness. Participants will be randomly assigned to a treatment or control condition,~     and complete a pre-assessment and then a post-assessment two weeks later. The assessment~     consists of a multimodal approach (e.g., self-report, physiological response, and overt~     behavior). Participants in the treatment condition will be instructed to watch a standard~     exposure video of a dental examination and prophylaxis three times daily for two weeks. One~     week of videos was shown in a first-person perspective and the same video will be shown in a~     third-person perspective for one week. The study can demonstrate the potential utility of~     smartphone-based self-directed exposure therapy for specific phobia.~   "
8085|NCT03461003|"~     The single patient (n-of-1) randomized trial is an underused approach to resolving~     therapeutic uncertainty by using a patient's own data to inform an individualized treatment~     plan. The proposed research is designed to assess whether the n-of-1 trial approach improves~     blood pressure control. This trial will advance learning about not only the treatment of~     pediatric hypertension but also the use of a neglected type of randomized trial to optimize~     the care of each patient.~   "
8086|NCT03460990|"~     This study will evaluate the efficacy of VX-659 in triple combination (TC) with tezacaftor~     (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous for the~     F508del mutation (F/F).~   "
8087|NCT03460977|"~     A Phase 1 Dose Escalation and Expanded Cohort Study Of PF-06821497 In The Treatment Of Adult~     Patients With Relapsed/Refractory Small Cell Lung Cancer (SCLC), Castration Resistant~     Prostate Cancer (CRPC) And Follicular Lymphoma (FL).~   "
8088|NCT03460964|"~     This pilot clinical trial will explore the accuracy and acceptability of a non-invasive,~     wearable glucose sensor in patients living with DM. This study will compare needleless~     glucose sensor readings from sweat with glucometer measurements from patients with any type~     of diabetes at fasting, and after a meal.~   "
8089|NCT03460951|"~     The main purpose of this study is to assess the clinical feasibility of diffusion tensor~     imaging (DTI) for the diagnosis of chronic inflammatory demyelinating polyradiculoneuropathy~     (CIDP). For thar purpose, investigator will compare, fractional anisotropy (FA) obtained by~     diffusion tensor imaging (DTI) MRI 3T on brachial plexus and cervical spinal nerve roots~     between patients with defined Chronic Inflammatory Demyelinating Polyradiculoneuropathy~     (CIDP), according to the EFNS 2010 criteria, and healthy controls.~      The secondary outcomes will be to compare DTI parameters (FA, ADC or Apparent Diffusion~     Coefficient) between CIDP patients, healthy volunteers, and patients with Charcot Marie Tooth~     disease type 1a (CMT1a) and MRI morphological parameters (T1, STIR) between these groups.~     Moreover, investigator will investigate the possible relationship between MRI parameters,~     clinical indices, and electrophysiological measure.~   "
49035|NCT02925104|"~     Dose escalation study to assess PK, safety and tolerability of INC280 when taken with food in~     patients with cMET dysregulated advanced solid tumors.~   "
8090|NCT03460938|"~     High-risk abdominal surgery is frequently complicated by postoperative complications, such as~     sepsis, pneumonia or anastomotic dehiscence. Asymptomatic myocardial injury after abdominal~     surgery (MINS) predicts non-cardiac complications. The etiology of MINS in abdominal surgery~     patients is unknown. Remote ischemic preconditioning (RIPC) is a physiologic mechanism that~     exposes tissues to brief periods of non-lethal ischemia and reperfusion, creating resistence~     for future serious ischemic insults. RIPC in patients after cardiac or aortic surgery is~     associated with a protective effect on the heart. The effect of RIPC in abdominal surgery~     patients is unknown.~      Objective of the study: To determine the effect of RIPC on MINS in patients after pancreatic~     sugery.~      Study design: Randomised controlled parallel group mono-center pilot study.~      Study population: 90 adult patients scheduled for elective pancreaticoduodenectomy in St.~     Antonius Hospital (45 in the intervention group and 45 in the control group).~      Intervention: RIPC: 3 periods of 5 minutes of ischemia followed by 5 minutes of reperfusion~     are created by inflating a blood pressure cuff on the upper extremity after induction of~     anesthesia and prior to surgery. In the control group a non-inflated blood pressure cuff is~     placed on the upper extremity for 30 minutes.~      Primary study parameters/outcome of the study: Maximum postoperative concentration of~     high-sensitive cardiac troponin T.~      Secondary study parameters/outcome of the study: Markers of inflammatory, intestinal and~     renal injury, postoperative complications during 30 days, length of stay and hospital~     mortality.~   "
8091|NCT03460925|"~     Evaluation of clinical response in terms of resectability of patients with locally advanced~     pancreatic cancer treated with neoadjuvant chemotherapy plus stereotactic body radiotherapy.~   "
8092|NCT03460912|"~     Intraoperative nerve monitoring is often used in many centers during thyroidectomy. According~     to the investigators' knowledge, there's no study showing superiority between bipolar and~     monopolar stimulation probes used for nerve monitoring during thyroid surgery. In this study,~     the investigators aimed to compare two different types of probes and find out~     superiorities.Twenty-one patients who underwent primary total thyroidectomy or~     hemithyroidectomy were included in the study. During surgery, amplitude and latency values~     obtained in the same patient with both bipolar and monopolar stimulation probes from 10~     different anatomical spots [vagal nerve, recurrent laryngeal nerve inferior portion,~     recurrent laryngeal nerve superior portion, external branch of superior laryngeal nerve~     (EBSLN)] were recorded prospectively, both when sheath was intact and after being dissected.~   "
8093|NCT03460899|"~     This experimental study is planned to investigate the impact of hypoglycaemia on platelet~     activation parameters (PAP) during a hyperinsulinaemic hypoglycaemic clamp study. The~     hypothesis that hypoglycaemia in patients with Diabetes Mellitus, Type 2 (T2DM) leads to~     increased platelet activation will be tested.~   "
8094|NCT03460886|"~     The aim of this study is to investigate the most effective stimulation site in transcranial~     direct current stimulation for gait recovery after stroke. All subjects will go through four~     conditions of transcranial direct current stimulation with for 30 minutes. Four conditions~     are 1) bihemispheric stimulation - anodal stimulation on both ipsilesional and contralesional~     leg area of primary motor cortex and supplementary motor area. 2) ipsilesional stimulation -~     anodal stimulation on ipsilesional leg area of primary motor cortex and supplementary motor~     area. 3) contralesional stimulation - anodal stimulation on contralesional leg area of~     primary motor cortex and supplementary motor area. 4) sham stimulation. Subjects will walk on~     treadmill for 10 minutes during transcranial direct current stimulation. Motor evoked~     potential and functional evaluations will be done before and after stimulation to measure the~     changes.~   "
8095|NCT03460873|"~     Prognostic factor in the patients with benign prostatic hyperplasia (BPH) who undergo holmium~     laser enucleation of the prostate~   "
8096|NCT03460860|"~     The purpose of this study is to determine the clinical efficacy of a combination of~     Astaxanthin (2 mg), Lycopene (1.8 mg), and d-alpha-Tocopherol (10 IU) in terms of its skin~     anti-aging properties. Specifically, the investigators aim to determine the increase in~     hydration levels of the skin, decrease in atypical skin pigmentation, and reduction of signs~     of photoaging, particularly facial fine lines.~   "
8097|NCT03460847|"~     Alterations in the intestinal microbiota have been associated to disease pathogenesis in~     ulcerative colitis. Refractory disease to standard medical therapy as corticosteroids often~     leads to an unfavourable course in patients suffering from this disorder. This study proposal~     aims at investigating changes in the intestinal microbiota that can predict a therapy~     refractory course of ulcerative colitis (UC) and may be used to identify high risk patients~     in an early phase of their disease.~   "
8098|NCT03460834|"~     Obesity is associated with poor asthma control and greater healthcare utilization and costs.~     In this study the researchers will examine the biologic and behavioral interrelationships~     between these conditions and their impact on outcomes. Towards this end, the researchers will~     conduct an observational prospective cohort study of 400 obese asthmatic patients treated at~     institutions in New York City and Denver, and develop and pilot test educational and~     counseling modules that take an integrated approach to asthma and obesity self-management~     support.~   "
8099|NCT03460821|"~     The aim of the entire project was to perform a translation and cultural adaptation of the~     Addenbrooke's Cognitive Examination - III (ACE-III), adhering to the Translation and Cultural~     Adaptation of Patient Reported Outcomes Measures—Principles of Good Practice, in order to~     make it available to German clinicians.~      Part of the translation process is the cognitive debriefing which will be performed as a~     survey which rates the applicability of every single item as well as of the entire~     Addenbrooke's Cognitive Examination - III tool.~   "
8100|NCT03460808|"~     Single-arm, open-lable, multicentre study to compare the efficacy and safety of atorvastatin,~     acetylcysteine plus danazol with danazol monotherapy in patients with~     corticosteroidresistant/relapsed ITP.~   "
8105|NCT03460743|"~     Multicentric study, Phase III; this study is a randomized, participant- and observer-blind,~     parallel group evaluation to evaluate the immunogenicity, relative efficacy, safety and~     reactogenicity of a recombinant quadrivalent hemagglutinin influenza vaccine versus an~     inactivated quadrivalent influenza vaccine in pediatric subjects and adolescents of 3-17~     years of age. Investigational vaccine is indicated for active immunization against influenza~     A and B for strains contained in the vaccine marketed in the United States for persons 18~     years of age or older.~   "
8106|NCT03460730|"~     To explore a further dimension of susceptibility to disease, the investigators tested the~     hypothesis that natural variation exists in the rapidity of IgG responses following exposure~     to pneumococcal polysaccharides, and that these differences are sufficiently great to affect~     susceptibility to and outcome of IPD. The study recruited children aged 24-36 months, who had~     recovered from IPD, and age-matched healthy controls and vaccinated them with 1 dose of the~     23-valent PPV to mimic natural exposure. The investigators collected serum samples after~     vaccination and analysed the dynamics of anti-polysaccharide antibody responses to several~     capsular antigens.~   "
8107|NCT03460717|"~     To trial a traditional pain management technique from Ayurveda in a modern way - the~     technique involves micro - cautery to painful areas in knee osteoarthritis for patients on a~     waiting list for knee replacement. The Investigators will include a waiting list control~     series.~   "
8108|NCT03460704|"~     The co-primary objectives of the trial are to investigate the effect of the use of inhaled~     colistimethate sodium, administered twice daily via the I-neb for 24 months, compared to~     placebo in subjects with non-cystic fibrosis bronchiectasis (NCFB) chronically infected with~     P. aeruginosa on:~        -  the frequency of pulmonary exacerbations;~        -  the number of exacerbation-free days.~   "
8109|NCT03460691|"~     Nowadays obesity is emerging as a very common health problem. It has been shown in various~     studies that obesity may be an important risk factor for the onset and progression of knee~     osteoarthritis (OA). The aim of this study is to determine the effects of bariatric surgery~     on knee pain, loss of function, quality of life and central sensitization.~   "
8110|NCT03460678|"~     The purpose of this multicenter randomized study is to compare the effectiveness and safety~     of erlotinib and pemetrexed in the maintenance treatment of patients with advanced~     non-squamous non-small cell lung cancer (NSCLC)~   "
8111|NCT03460665|"~     The aim of this double-blind, randomized, single-center prospective study (patient and~     evaluator) is to evaluate the efficacy of arterial occlusion (embolization) of neovessels by~     microparticle versus placebo on pain in disabling knee osteoarthritis at 12 months.~   "
8112|NCT03460652|"~     This study is a multicenter, dose-optimized, open-label safety study with KP415 in children~     with Attention-Deficit/Hyperactivity Disorder (ADHD).~   "
8113|NCT03460639|"~     Orofacial pain encompasses painful conditions, such as temporomandibular disorder.~     Multidisciplinary health teams seek to control such musculoskeletal disorders to improve the~     quality and functional capacity of the muscles of mastication. The aim of the proposed study~     is to evaluate the effect of low-level laser therapy as a form of treatment for the~     prevention of initial fatigue of the muscles of mastication (masseter and anterior temporal~     muscles) as well as the recovery of these muscles after induced exhaustion (caused by~     isometric contraction) in young adults. The participants will be 78 (n obtained from~     calculation of the sample size with p < 0.05) healthy male and female volunteers between 18~     and 34 years of age. The volunteers will be randomly allocated to a laser group (n = 26),~     sham group (n = 26) and control group (n = 26). All participants will be submitted to a~     clinical evaluation to record mandibular movements, bite force, muscle sensitivity to~     palpation and initial muscle fatigue. Initial fatigue will be induced by isometric~     contraction of the jaws. Maximum voluntary contraction will be performed to record the time~     until initial exhaustion of the masseter muscle (determined by electromyography). The groups~     will then be submitted to the interventions: 1) active laser therapy (wavelength: 780 nm;~     fluence: 134 J/cm2; power: 50 mW; irradiance: 1.675 W/cm2; exposure time: 80 seconds per~     point) on three points of the masseter and one point on the anterior temporal muscles on each~     side, 2) sham laser (placebo effect) or 3) no intervention (control). Maximum voluntary~     contraction will be performed again after the interventions to record the time until initial~     exhaustion of the masseter muscle (determined by electromyography). Differences in individual~     time until exhaustion between the pre-intervention and post-intervention evaluations will be~     measured to determine the effect of low-level laser therapy.~   "
8114|NCT03460626|"~     Stress affects the health and is prevalent among medicine and pharmacy students. A number of~     factors such as busy schedules, course load and lack of recreational time during semesters as~     well as exams, have been reported to be associated with stress. Study reports that the use of~     aroma oils especially those with relaxant properties can alleviate the level of stress. This~     study aims to investigate the effects of aroma oils in stress during exams in pharmacy~     students.~   "
8115|NCT03460613|"~     Irritable bowel syndrome (IBS) is a disorder of gastrointestinal function characterized by~     abdominal symptoms and pain associated with alterations in bowel habit. The condition impacts~     on the quality of life of at least 10% of the population, impacts on activities of daily~     living and is associated with considerable direct and indirect costs to the individual, the~     health system and society. The etiology of IBS appears multifactorial and several mechanisms,~     among them mucosal inflammation, abnormal intestinal motility, visceral hypersensitivity and~     psychological factors, appear to be involved.~      An underlying pathophysiology, namely Joint Hypermobility (JH) and Joint Hypermobility~     Syndrome (JHS), that we are going to study, have recently gained increasing attention in~     patients with functional bowel disease.~      One factor which was shown in previous IBS-studies to reduce abdominal symptoms is a FODMAP~     diet.~      To identify FGID patients which profit most from different diagnostics and therapies (such as~     FODMAP diet) we are going to carry out a study analyzing different subtypes of FGID (in~     particular IBS, FD, functional abdominal pain/bloating) for demographics, clinical~     diagnostics (e.g. nutrient challenge testing, microbiome testing, anorectal manometry and MR~     defecography), comorbidities (in particular JH, JHS and psychological comorbidities) and~     treatment.~   "
8116|NCT03460600|"~     Optical Coherence Tomography (OCT) is a relatively new imaging technique in ophthalmology.~     This clear and documented imaging identified new diseases/ observations that were not~     previously known.~   "
8117|NCT03460587|"~     The aim of the current protocol is to study 40 patients, each for 90 days, to address~     hypotheses related to the ability of a telerehabilitation system to (a) improve motor status~     and disability, (b) collect various forms of patient data from the home, (c) improve risk~     factor knowledge and control, and (d) assess patient compliance with home-based~     telerehabilitation.~      Patients who have returned to their home after stroke will be provided with a telehealth~     system and be asked to use it 6 days/week for 90 days, during which time subjects will use~     this system for daily rehabilitation therapy, assessments, and education--all on one~     platform.~   "
8118|NCT03460574|"~     Research has shown that people suffering from MDD tend to maintain dysfunctional expectations~     despite experiences that disconfirm expectations. Recently, it has been shown that this~     persistence of expectations is due to maladaptive information processing involving cognitive~     immunization. This experimental study aims at testing three different strategies to inhibit~     cognitive immunization, in order to enhance expectation change.~   "
8139|NCT03460301|"~     Patients who are positive of PNH-type cells are followed up for the percentage of PNH-type~     cells regularly for examining how it change.~   "
8119|NCT03460561|"~     Thoracic epidural analgesia (TEA) can be considered the gold standard for postoperative~     analgesia in major abdominal surgeries, as proved by a lot of number of systematic reviews~     and meta-analyses have demonstrated that TEA was associated with superior postoperative~     analgesia, better patients' outcomes, reducing (systemic opiate requirements, ileus and~     pulmonary complications).~      The rectus sheath block (RSB) is effective for the surgeries that necessitated midline~     abdominal incisions as local anesthetics instillation will be within the posterior rectus~     sheath bilaterally providing intense analgesia for the middle anterior wall from the xiphoid~     process to the symphysis pubis in adults.~   "
8120|NCT03460548|"~     The efficacy and safety of Remogen® Omega in the treatment of dry eye signs and symptoms will~     be investigated in comparison to Cationorm®.~   "
8121|NCT03460535|"~     This is a purely observational project and the objectives are to record and analyze the local~     potentials at the site of Premature Ventricular Contraction (VPC) focus through the Rhythmia~     system, ti determine the short and long-term success of the procedure and compare it to the~     existing literature about standard procedures, to highlight the advantages of the system~     compared to conventional mapping and to characterize optimal pace map or activation map as~     achieved by the Rhythmia system.~   "
8122|NCT03460522|"~     The trial proposed to evaluate the efficacy and safety of an inotuzumab ozogamicin followed~     by an age-adapted intermediate intensive consolidation therapy and maintenance treatment in~     patients with acute lymphoblastic leukemia older than 56 years~   "
8123|NCT03460509|"~     Neuromuscular blocking agents (NMBA) are among the most commonly used drugs during general~     anesthesia and may induce complete muscle paralysis.They are used clinically to facilitate~     endotracheal intubation and to optimize surgical working conditions. Incomplete recovery from~     non-depolarising NMBAs continues to be a common problem in modern postoperative care unit and~     is associated with significant risk of microaspiration and hypoventilation which leads to~     pulmonary complications.Recently effective reversal of neuromuscular blockade has been~     described by use of lower dose of sugammadex the recommended without providing adequate~     answer to whether the lower dose is safe enough to avoid recurrent block.~      Hypotheses:~        1. Administration of sugammadex 0.25 mg/kg at TOF ratio 0.3 will successfully reverse~          (TOF=0.9) rocuronium induced neuromuscular block within 10 min.~        2. Recurrent block (TOF ratio < 0.9) does not occur after reversal with low dose sugammadex~          0.25 mg/kg.~      The primary objective of this trial is to assess the dose-response characteristics of~     sugammadex in reversing rocuronium induced neuromuscular block and to identify the minimal~     effective dose~      Secondary objective is to assess the safety of different doses of sugammadex (recurrent block~     (TOF ratio < 0.9) after reversal and the occurrence of adverse reactions)~      Sugammadex is a very expensive drug which limits its use i anaesthesia department. By~     optimising drug dosage it may have economic impact and contribute to a wider use of~     sugammadex to reverse neuromuscular block before extubation and thus avoid incomplete~     recovery. This may lead to less risk for postoperative pulmonary complications and thereby~     reduce morbidity and mortality after surgery.~   "
8124|NCT03460496|"~     Preterm birth is associated with significant and often life-long developmental, emotional and~     financial burdens. Preterm infants face several challenges that continue late into life,~     including developmental delays, social, and behavioural problems and poor academic~     performance. Parents also suffer considerable emotional and physical stress which in turn can~     have a negative impact on the child's development.~      In Switzerland, during the transition from hospital to home, there are not many interventions~     intended to improve mental health outcomes in parents or to promote positive parenting to~     improve developmental outcomes for the preterm infant. There are also few interventions to~     reduce associated health care costs.~      In order to improve parent and preterm infant outcomes, reduce hospital stay in the neonatal~     intensive care unit (NICU), lower readmission rates, and avoid unnecessary use of primary~     care resources a unique, new model of transitional care was developed. The new 'Transition to~     Home' (TtH) model makes use of well-tested, successful methods of post-discharge care.~      The investigators' study will evaluate the organizational and financial feasibility and cost~     effectiveness of the TtH model for infants born preterm by measuring the impact of an~     Advanced Practice Nurse (APN)-led intervention at the Children's University Hospital Bern.~     The intervention focuses on improving parental mental health and well-being, on infant growth~     and development, and on lowering overall costs. The investigators will gather data and then~     adapt and test the model within a longitudinal interventional comparative effectiveness~     study, and prepare it for other Cantons in Switzerland to implement.~   "
8125|NCT03460483|"~     This clinical trial studies universal screening for deoxyribonucleic acid (DNA) mismatch~     repair deficiency in patients with endometrial cancer, mutations in the genes responsible for~     Lynch syndrome (inherited forms of endometrial cancers) and other DNA changes that could help~     guide treatment strategies. Universal tumor DNA sequencing may help doctors better understand~     how to personalize care, increase length of life, and increase quality of life in patients~     with endometrial cancer and their relatives.~   "
8126|NCT03460470|"~     This protocol describes a 2-arm randomized controlled pilot study assessing the tolerance,~     safety and efficacy of sildenafil compared to control. The hypothesis is that sildenafil will~     be well tolerated and efficacious in patients with chronic heart failure (NYHA class II and~     III) with evidence of systolic dysfunction (EF ≤40 %) and secondary pulmonary hypertension~     (SPAP >40mmHg).~      Patients that satisfy the inclusion criteria will be randomized to sildenafil (40mg x 3) or~     placebo therapy for 6 months in a 2:1 blinded fashion. The placebo group will be compared to~     the active therapy group and analyzed for differences in the main study end-points Patient~     Global Assessment and 6-Minute Walk Test.~      The study will also assess safety, tolerability, symptoms and quality of life.~   "
8127|NCT03460457|"~     To study the pharmacokinetic characteristics of TQB2450 in the human body, recommend a~     reasonable regimen for subsequent research.~   "
8140|NCT03460288|"~     The study examines the efficacy and acceptance of a computer-based training program for~     individuals with problematic or pathological gambling behavior. The study intends to~     investigate the extent to which the computer-based training program leads to a significant~     reduction in pathological gambling (primary outcome) when compared to a control group. The~     study design is a randomized-controlled trial with one intervention group and one wait-list~     control group.~   "
8128|NCT03460444|"~     Ketogenic diets are gaining support as a method to lower inflammation within the body, but~     studies have not been able to show the way by which this occurs. Ketones, which are molecules~     made by the body as a source of energy during carbohydrate restriction, have been shown to~     have the ability to alter the number and types of messages that immune cells send to each~     other, and thus have the potential to lower inflammation. To determine whether raising~     ketones independent of diet reduce inflammation, 20 healthy, young men will follow a 14-day~     normal diet combined with MCT oil supplements. Based on previous research, the~     investigators expect that raising ketones will reduce immune cell pro-inflammatory signaling.~   "
8129|NCT03460431|"~     clinical comparative study comparing the effectiveness of fractional CO2, long pulsed Nd YAG~     and their combination in collagen remodeling in keloid clinically, biochemically and~     histopathologically~   "
8130|NCT03460418|"~     Proximal humerus fractures are more common in older people. They can be caused by a minor~     trauma on an osteoporotic bone.~      Non- or little-displaced proximal humerus fractures are treated orthopedically. When the~     displacement is more important, the choice of the treatment is crucial and the algorithm of~     treatment is in permanent evolution. The technology and design of the implants and the~     operative techniques of osteosynthesis and arthroplasty have evolved. Patients live longer,~     they lead a more active life and their expectations have changed. The goals of the treatment~     should be an increase in shoulder function and a decrease in treatment failure.~      This study analyzes the results of the treatment by intramedullary osteosynthesis using a~     Multiloc nail from Synthes between 2012 and June 2017. The study will compare the functional~     results obtained after fixation by a Multiloc nail, a Philos plate or arthroplasty.The~     functionality of the shoulder and the quality of life will be evaluated according to the type~     of treatment.~   "
8131|NCT03460405|"~     This study is to assess the safety and immunogenicity of Vi-DT vaccine in adults, adolescent,~     children and infants.~   "
8132|NCT03460392|"~     The aim of the present study is to characterize the bacterial composition (microbiota)~     colonizing to the human body in different physio - pathological conditions (lifestyle, motor~     activity, surgical operations, probiotic and prebiotic consumption, antibiotic therapies,~     chemotherapeutic therapies), nervous and musculoskeletal diseases, gastrointestinal and~     metabolic disorders , oral and vaginal diseases, etc.). In particular, they will be~     investigate:~        -  the changes in the bacterial abundance~        -  the potential microbial interactions with the human host~        -  the microbial networks describing on the bacterial interactions within a specific~          composition of the human microbiota~   "
8133|NCT03460379|"~     Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the~     pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the~     pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery.~     Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological~     availability of medication. In this study the pharmacokinetic effects of bariatric surgery on~     escitalopram are investigated.~   "
8134|NCT03460366|"~     Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the~     pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the~     pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery.~     Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological~     availability of medication. In this study the pharmacokinetic effects of bariatric surgery on~     enalapril are investigated.~   "
8135|NCT03460353|"~     Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the~     pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the~     pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery.~     Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological~     availability of medication. In this study the pharmacokinetic effects of bariatric surgery on~     dexamphetamine are investigated.~   "
8136|NCT03460340|"~     Purpose: The purpose of the study is to explore the efficacy of H1 deep TMS for the treatment~     of FMS.~      Design: Prospective randomized sham controlled trial Study Population & sample size:forty~     (40) FMS subjects between 18-80 years of age.~      No. of Centers: Four centers-~        1. Shalvata Mental Health Center, Tel -Aviv University, Israel.~        2. Soraski medical center, Tel-Aviv University, Israel.~        3. Sheba Medical Center, Tel-Aviv University, Israel~        4. Beer-Yakov Mental Health Center, Tel-Aviv University, Israel. Duration and intensity of~          Treatment: All subjects will receive prefrontal deep rTMS of H1 Coil (75 trains of 2~          seconds, 20 Hz, with 20 seconds inter-train intervals, up to 120% of motor threshold, a~          total of 3000 pulses per session), for 4 weeks, 5 days a week, overall 20 sessions.~      Name of device: The Brainsway Ltd. H1-Coil~      Study Endpoints: Clinical outcome:~      primary outcome Change in self-reported average pain intensity over the last 24 hours will be~     measured at the end point with the numerical scale (0 = no pain, 10 = maximal pain~     imaginable) of the VAS-FIQ.~      secondary outcome~        1. Change of sensory and affective pain dimensions will be measured at the end point using~          the McGill Pain Questionnaire.~        2. Change of the impact of pain and FMS on quality of life, will be measured at the end~          point using the BPI items for pain interference.~        3. change of sensitivity to painful stimuli will be evaluated by physical measurements:~             -  WPI~             -  SSS~        4. Changes in cognitive functions in domains of attention, working memory, spatial memory,~          executive functions and social cognition will be measured at the beginning and end point~          of the study using the Penn Web-Based Computerized Neurocognitive Battery (WebCNP).~   "
8137|NCT03460327|"~     Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the~     pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the~     pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery.~     Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological~     availability of medication. In this study the pharmacokinetic effects of bariatric surgery on~     candesartan are investigated.~   "
8138|NCT03460314|"~     Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the~     pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the~     pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery.~     Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological~     availability of medication. In this study the pharmacokinetic effects of bariatric surgery on~     buprenorphine are investigated.~   "
8141|NCT03460275|"~     Based on the existing research results, Osimertinibi is effective not only for patients with~     sensitizing EGFR mutations, but also for other less common EGFR mutations. However, no~     studies have been done so far regarding the difference in efficacy of various EGFR mutation~     subtypes. Meanwhile, the presenting studies data of the safety and efficacy of Osimertinib as~     first-line therapy for NSCLC is very limited. Therefore, this study aims at assessing the~     safety and efficacy of Osimertinib as First-line therapy for patients with EGFR~     mutation-positive locally advanced or Metastatic Non-squamous NSCLC as well as the its~     difference in efficacy of various EGFR mutation subtypes.~   "
8142|NCT03460262|"~     Surgical site infection in vascular surgery is a relatively common event with reported~     incidence as high as 43%. When considering the groin alone, the incidence is around 20% (30%~     when considering any wound complication). This complication may sometimes lead to heavier~     complication (leg amputation, longer hospital stay, high costs…) and affects the early~     postoperative quality of life of the patients.~   "
8143|NCT03460249|"~     The investigators plan to determine if the sequence of blood pressure measurements from the~     sitting position to the table and vice versa has an impact on the measurements.~   "
8144|NCT03460236|"~     Knee Osteoarthritis (OA) is a leading cause of premature disability in Veterans who develop~     knee OA at higher rates and younger ages than the population in general. For those with~     symptomatic early knee OA, who are years to decades away from meeting clinical indications~     for knee replacement surgery, knee injections have been a key treatment option. In recent~     years, platelet rich plasma (PRP) injections have gained increasing attention for improving~     pain and function in patients with knee OA. Basic science studies also suggest that PRP may~     also potentially stimulate repair responses to articular cartilage. However, the mechanisms~     of action of PRP in the treatment of knee OA are unknown. Because autologous blood is used,~     the PRP composition differs between patients. It is also unknown whether these differences in~     PRP composition affect clinical outcomes. This study will address these gaps and provide~     critical new and objective information on PRP treatment effects in Veterans and additional~     women with early knee OA important to improving clinical use of this new treatment.~   "
8145|NCT03460223|"~     In progressive kidney diseases, fibrosis represents the common pathway to end-stage kidney~     failure. The potential for stem cells to treat kidney failure was recently confirmed.~     Particularly, mesenchymal stem cell (MSC) has been demonstrated to protect kidney function~     and alleviating renal injury in these patients. Therefore, the investigators propose a~     hypothesis that MSCs (MSC) can also improve the disease conditions of kidney fibrosis~     patients, particularly reducing the decompensated conditions in these patients.~   "
8146|NCT03460210|"~     Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the~     pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the~     pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery.~     Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological~     availability of medication. In this study the pharmacokinetic effects of bariatric surgery on~     atomoxetine are investigated.~   "
8147|NCT03460197|"~     There are various techniques to obtain tissue samples by using fine needle guided by~     endoscopic ultrasound (EUS). These techniques attempt to obtain the most adequate material~     with the best quantity and quality for analysis. Currently studies that compare the results~     concerning capillary technique versus wet technique are not available. In this sense, the~     authors consider necessary to explore both techniques documenting the results that can define~     which could be the best method so that it can routinely be used in cases of digestive~     neoplasia.~   "
8148|NCT03460184|"~     comparing the effect of general anesthesia versus spinal anesthesia on brain natruretic~     peptide hormone levels preoperatively and postoperatively in parturient cardiac patient~     undergoing cesarean section~   "
8149|NCT03460171|"~     The human metapneumovirus (hMPV) was first described in 2001. It belongs to the paramyxovirus~     family and is genetically close to the Respiratory Syncytial Virus (RSV). hMPV has a seasonal~     epidemic pattern, between January to April. Clinical symptoms of hMPV infection include~     influenza-like illness (fever, asthenia and curvatures) associated with signs of respiratory~     tract infection. The incidence of hMPV infection is higher in children than in adults. In~     child pneumonia, hMPV is the third most frequent isolated pathogen (14 % of the subjects),~     after rhinovirus and RSV. In hospitalized adults, hMPV was detected in 6 to 8% of the~     subjects with lower respiratory tract and in 4 % of subjects with pneumonia.~      Clinical, radiological and biological features, as well as evolution course of hMPV~     infections have been mainly described in children. Clinical presentation of in adult seems~     polymorph, ranging from acute bronchitis or exacerbation of COPD to pneumonia. The frequency~     of viral-bacterial coinfection is unknown. Intensive care unit (ICU) admission may involve~     almost 1 for 10 patients. Elderly and immunocompromised subjects are probably high-risk~     subjects.~      Currently, treatment of hMPV infections is mainly symptomatic. However, several anti-RSV~     drugs that are currently in clinical development have demonstrated an activity against other~     paramyxoviridae in pre-clinical studies. Consequently, it seems necessary to better~     characterize hMPV infections in adult inpatients: presentation, course profile and risk~     factors for morbidity and mortality. These data would help clinicians to identify high risk~     patients, and consequently to choose those who could benefit from coming treatments.~      The French hMPV Study is observational prospective multicenter clinical study. The study~     population includes all consecutive adult inpatients with a community-acquired acute lower~     respiratory tract infection and a mPCR positive for hMPV on any respiratory sample. The~     primary objective is to describe the prognosis. The secondary objectives are i) to~     characterize clinical, radiological and biological features, ii) to describe the hospital~     course and the rate of ICU transfer; in ICU patients, to describe organ failures and~     supports, and iii) to describe the viral and/or bacterial coinfections. The primary endpoint~     is the number of subjects with a poor outcome (defined by the requirement for invasive~     mechanical ventilation and/or the death during the hospital stay).~   "
8150|NCT03460158|"~     A prospective, trial to quantitatively and qualitatively compare the dermal fillers for the~     treatment of age related aesthetic changes.~   "
8151|NCT03460145|"~     Assessment of how Lavender oil reduces preoperative anxiety and subsequently influences~     requirement of induction agents for general anesthesia.~   "
8152|NCT03460132|"~     The use of miniscrew implants as an anchorage device in orthodontics has gained a widespread~     acceptance in recent years. There prevailed use has been attributed to its ease in insertion~     and removal at a relatively low cost with no need to wait for a long time between miniscrew~     insertion and force application. In this regard; clinical studies have suggested that~     miniscrew implants may provide stable anchorage during the orthodontic treatment without~     requiring patient cooperation. These studies proved many successful applications in~     orthodontics involving; retraction of anterior teeth, correction of open bites,~     distalization, mesialization, and intrusion of teeth~   "
8153|NCT03460119|"~     The aim of this study was to describe the changes in respiratory rate, heart rate and~     dyspnea, before and after using HFNC in patients presenting to our emergency department with~     ARF.~   "
8156|NCT03460080|"~     The incidence of Hepatocellular carcinoma (HCC) is increasing worldwide. However, most of HCC~     cases were at advanced stage when the diagnosis established.Early diagnosis improves the~     prognosis.The study is intended to evaluate the diagnostic efficiency of alpha-fetoprotein-L3~     (AFP-L3) and Protein Induced by Vitamin K Absence or antagonist-II (PIVKA-II). This study is~     performed at Hanoi Medical University Hospital. Participants including patients with HCC and~     hepatic hemangioma. All the serum samples are collected before any treatments and will be~     tested in single center in order to decrease bias. Serum samples were tested for PIVKA-II,~     AFP, AFP-L3 and biochemical indexes including alanine aminotransferase(ALT),aspartate~     aminotransferase (AST), gamma-glutamyl transferase, HbsAg, Anti HCV, etc.~   "
8157|NCT03460067|"~     The primary objective of this study is to describe the rate of local control in patients with~     her-2 positive early stage breast cancer with a complete response to chemotherapy and~     lumpectomy alone.~   "
8158|NCT03460054|"~     Glomerulonephritis (GN) is one of the most important causes of kidney failure in Canada.~     These comprise a group of rare diseases (<5 per 250,000 population), yet GN is a leading~     cause of kidney failure and accounts annually for close to 20% of incident cases of end stage~     kidney disease (ESKD) in Canada. Prevention of progression to kidney failure is possible,~     however several barriers and gaps in knowledge challenge our ability to provide patients with~     individualized effective therapy. These include a lack of sensitive non-invasive tools for~     monitoring disease activity, prognosis, and response to therapy. A gap in understanding of~     the core molecular processes underlying the development and progression of GN, and a lack of~     cohesive networks for evaluation of novel treatment approaches contribute to a lack of~     targeted and personalized therapies for GN. To address these challenges we will create a~     national, multi-dimensional platform for application of human-based molecular research and~     advanced therapeutics in GN.~   "
8159|NCT03460041|"~     This study will be performed in Abo Elreesh Pediatric Hospital / Cairo University after~     obtaining approval by the University Ethics Committee, and a written informed consent from~     the parents or guardians.~      Thirty six patients will be randomly assigned using an online randomization program~     (http://www.randomizer.org) and the sealed envelope method into three groups: Group D (n=12):~     Dexmetedomidine group. 0.5 ml of dexmetedomidine (2 μg/kg) added to bupivacaine, Group M~     (n=12) : Magnesium group.0.5 ml of magnesium sulphate (50 mg) added to bupivacaine, Group C~     (n=12) :Control group.bupivacaine 0.25% diluted in normal saline with total volume of 1~     ml/kg.~   "
8160|NCT03460028|"~     This randomized controlled trial will evaluate a yoga intervention for individuals who~     experience persistent pain following oncology surgery. The integrated yoga program will~     involve postures, breathing exercises, and concentration practices. Data will be collected at~     several time points (pre-, mid-, and post-intervention) for both the intervention and~     wait-list control conditions. The data will be analysed using linear mixed effects growth~     models. Results will be written up in manuscript format, published in a peer review journal,~     and disseminated at scientific research conferences.~   "
8161|NCT03460015|"~     Prospective, open-label, single-center, study to investigate the effect of sevoflurane~     sedation compared to a propofol-controlled arm during COPD exacerbation requiring invasive~     mechanical ventilation in ICU.~      Primary outcome measure:~      Evolution of airway resistance before and after sevoflurane in COPD patients,~      Secondary outcomes measures:~      Respiratory mechanics (Maximum pressure, PEEPi and PEEPtot, trapped volume), Gas exchange by~     the help of blood gases, The heterogeneity of alveolar ventilation by electro-impedancemetry,~     Evolution of pulmonary inflammation, Trophicity and contractility of the diaphragm,~   "
8162|NCT03460002|"~     The world is set on eradicating measles and polio infections in the coming decade. Once both~     infections are under control, campaigns with measles and oral polio vaccines will be phased~     out. This might do more harm than good for child survival in low-income countries. Studies~     from the Bandim Health Project in Guinea-Bissau, and elsewhere, have revealed, that the live~     measles and oral polio vaccines have beneficial non-specific effects, i.e. effects on child~     morbidity and mortality unrelated to prevention of the targeted diseases.~      The campaigns are presumed to be most beneficial for children not reached by routine~     vaccination programs, as they are not already protected. However, studies show that prior~     routine or campaign vaccination may boost resistance against unrelated infections. If we~     phase out measles and oral polio campaigns after eradicating their target infections without~     considering the impact on child survival, the drastic decline in child mortality since 1990~     could change direction. We will conduct the first cluster randomized controlled trial to~     evaluate the effect of measles and oral polio campaigns on general child morbidity and~     mortality via the Bandim Health Project. Bandim Health Project runs a Health and Demographic~     Surveillance System in Guinea-Bissau since 1978 and assesses child health interventions'~     real-life effects, via continuous registration of all interventions given to all children,~     and follow-up of individuals. We will conduct the trial in rural Guinea-Bissau monitoring all~     nine health regions, covering 182 clusters, with 18,000 children <5 years. The hypothesis is:~     measles vaccine and oral polio vaccine campaigns in Guinea-Bissau reduce morbidity and~     mortality among children between 0 and 59 months of age by 20% during the subsequent 18~     months in a context of limited measles and no polio infections..~   "
8163|NCT03459989|"~     We are going to do 2d ultrasound to compare between hadlock's formula and thigh soft tissue~     formula in expecting the after birth fetal weight and to find which of these formulas to be~     more accurate~   "
8164|NCT03459976|"~     Evaluation of Serum level of Human Epididymis Secretory Protein 4 (HE4) in Benign Endometrial~     Disease and Endometrial Cancer~   "
8165|NCT03459963|"~     This study aims to compare the routine use versus non-use of urethral catheterization in~     women undergoing first elective cesarean section as regard to intraoperative and~     postoperative complications~   "
8179|NCT03459781|"~     Survivors of solid tumor cancers and their informal caregivers (family members or friends)~     experience significant impairments in health-related quality of life (HRQOL) including~     disruptions in psychological, physical, social, and spiritual well-being. Our prior work~     demonstrates that impairments in depression, anxiety, fatigue, and negative affect~     experienced by cancer survivors across time are strongly related to, or interdependent with,~     those experienced by their informal caregivers. These findings suggest that interventions~     directed simultaneously toward both members of the cancer survivor-caregiver dyad may be~     especially impactful in improving HRQOL in cancer survivors and informal caregivers. Although~     a number of interventions have been developed and tested to support the survivor or the~     caregiver, few have attempted to simultaneously intervene with both to improve HRQOL within~     the collective survivor-caregiver dyad. CBCT®, Cognitively-Based Compassion Training (already~     piloted by members of this team with breast cancer survivors, is an 8-week manualized~     meditation-based program that starts with attention and mindfulness training and builds to~     contemplation about compassion for the self and others. It differs from other meditation~     interventions in that it directly enhances self-compassion, feelings of social connection,~     empathy for others, and equanimity and by doing so lessens emotional suffering. Our recent~     findings suggest that CBCT® may reduce depressive symptoms, fear of cancer recurrence, and~     improve vitality in breast cancer survivors. The proposed pilot feasibility study builds upon~     this work to intervene with caregivers in addition to survivors of solid tumor cancers. The~     major aim of the proposed project is to test the feasibility and acceptability of CBCT® for~     survivors of solid tumor cancer and their informal caregivers after the end of cancer~     treatment. The project will also determine in a preliminary manner whether or not CBCT®~     (compared to a cancer health education [CHE] comparison group) has a positive impact on~     different measures of HRQOL (e.g. features of depression and anxiety, fatigue, social~     isolation), stress-related biomarkers of inflammation and cortisol, and assessments related~     to healthcare utilization (medication adherence and patient healthcare-related activation).~   "
8166|NCT03459950|"~     Insomnia belongs to the category ofsleeplessin Chinese medicine. Sleepless is defined as a~     persistent sleep disorder, results in some form of daytime impairment.~      Traditional Chinese medicine(TCM) has obvious advantages in the treatment of chronic~     insomnia, but there have some subjective and objective obstacles in the advantages of TCM~     treatment of replication, promotion, and popularization. Therefore, it is necessary to carry~     out the research from a multi-angle, and further summarize the ideas and methods from the~     perspective of TCM, to make it more objective, visual and standardized.~      Insomnia is a clinical manifestation of the disorders of the Zang and Fu, and it can further~     aggravate the dysfunction of the Zang and Fu. The Traditional Chinese medicine believes that,~     outward is the internal manifestation. Infrared image can reflect the state of cold and heat,~     yin and yang in all parts of human body. So it is called the CT of TCM. Pre-study found that~     patients with sleep disorders have different infrared image than normal changes.~     Polysomnography is currently recognized as the golden indicator of sleep research.~     Polysomnography can monitor the whole sleep process, and study the sleep structure by the~     related indexes, which is a basic technique for Sleep medical research and diagnosis of sleep~     disorders, and a standard method of evaluating sleep-related pathophysiology and sleep~     architecture. We will study the relationship between sleep structure of the PSG, the~     characteristics of infrared image, the four diagnostic information of TCM, and the~     self-rating scales of sleep and psychology in patients with chronic insomnia.~   "
8167|NCT03459937|"~     The focus of this study is to examine the feasibility of integrating Vinyasa yoga into a~     Standard Behavioral Weight Loss Intervention, to examine whether engagement differs between~     Vinyasa yoga and a restorative form of Hatha yoga within a Standard Behavioral Weight Loss~     Intervention, and to use this information to inform an expanded study to directly test the~     effectiveness of these interventions on weight loss in adults.~   "
8168|NCT03459924|"~     Cirrhotic patients undergoing liver transplantation might develop acute transient right~     ventricular dysfunction, ranging from mild to severe form. More than two decades ago, a~     number of studies with pulmonary artery catheters looked at this particular issue with~     controversial results. However, the pulmonary artery catheter as a monitor for right~     ventricular function (RVF) has several limitations, while the echocardiogram is deemed to be~     more accurate in this regard. Therefore, we sought to evaluate the RVF with the~     transesophageal echocardiogram, and particularly whether the RVF significantly varies during~     this procedure.~   "
8169|NCT03459911|"~     To demonstrate bioequivalence of single dose test formulation of Losartan potassium tablets~     (containing Losartan potassium 100 mg) of Pharmtechnology LLC, Republic of Belarus with~     reference Cozaar® (containing Losartan potassium 100 mg) of Merck Sharpe & Dohme B.V.,~     Haarlem, the Netherlands in normal, healthy, adult, human subjects under fasting~     conditions.To monitor adverse events and ensure the safety~   "
8170|NCT03459898|"~     The standard treatment for breast cancer is surgery followed by adjuvant breast radiation~     therapy in most cases. For left sided breast cancers, the heart dose delivered by the~     radiation treatment is often of particular concern. In order to spare the heart, different~     strategies are currently available, including active breathing control (ABC) and voluntary~     deep in inspiration breath hold (DIBH) (both strategies are currently being used at our~     centre). To perform accurate heart-sparing treatments, it is important to ensure that~     patients are positioned consistently. One available approach is through surface imaging which~     tracks the position of a portion of the skin surface, known as the AlignRT system (VisionRT~     Ltd, London, UK).~   "
8171|NCT03459885|"~     The investigators have recently shown in incomplete SCI patients that long-term paired~     associative stimulation is capable of restoring voluntary control over some paralyzed muscles~     and enhancing motor output in the weak muscles (1,2). In this study, the investigators will~     administer long-term paired associative stimulation to patients with incomplete cervical~     level SCI and investigate its effectiveness for lower extremity rehabilitation.~   "
8172|NCT03459872|"~     Can acupuncture be quantified. This study sets out to observe if there are measurable effects~     of fine motor control that are attributable to acupuncture. The study utilizes an FDA~     approved medical device for measurements of fine motor control called the RU-Fit.~   "
8173|NCT03459859|"~     The investigators hypothesize that the combination of Pevonedistat/Low-Dose Cytarabine (LDAC)~     therapy will be tolerable, that a recommended phase 2 dose of Pevonedistat in combination~     with LDAC will be identified, and that the combination therapy will show evidence of clinical~     activity in adult patients with Relapsed/Refractory Acute Myelogenous Leukemia (AML) and~     Advanced Myelodysplastic Syndromes (MDS).~   "
8174|NCT03459846|"~     A Phase II, Randomized, Multi-Center, Double-Blind, Comparative Global Study to Determine the~     Efficacy and Safety of Durvalumab in Combination With Olaparib for First-Line Treatment in~     Cisplatin-Ineligible Patients With Unresectable Stage IV Urothelial Cancer~   "
8175|NCT03459833|"~     This randomized controlled cross-over study aims to evaluate the effect and safety of glans~     penis augmentation using Hyaluronic acid in the treatment of premature ejaculation in compare~     with placebo .~   "
8176|NCT03459820|"~     This is a multi-center, single-arm, open-label, phase III trial in patients with~     biopsy-proven prostate cancer. Patients will receive regular standard of clinical care. The~     only study-specific procedures will the administration of 18F-DCFPyL followed by a PET/CT~     scan. Differences in theoretical optimal clinical management based on a review of clinical,~     biochemical and radiographic subject data before and after 18F-DCFPyL PET/CT imaging by a~     central panel of experts will be captured at study completion.~   "
8177|NCT03459807|"~     Blood pressure may be one of the most important modifiable risk factors for cardiovascular~     disease in patients with end-stage-renal-disease undergoing maintenance hemodialysis.~     Although a systolic blood pressure <140 mmHg treatment target has been recommended, there~     remains uncertainty on which blood pressure should be targeted, more specifically that~     measured in the dialysis unit or at home. Observational studies have reported a paradoxical~     U-shaped associated with dialysis unit (pre-dialysis) systolic blood pressure and~     cardiovascular events and death (where blood pressure below 140 mmHg is actually linked with~     poor outcomes). Conversely, the same studies have reported a linear association between~     higher home systolic blood pressure and worse clinical outcomes, where blood pressure below~     140 mmHg is associated with better outcomes. This pilot clinical trial aims to address this~     important question.~   "
8182|NCT03459742|"~     School-based interventions have shown mixed results. Most studies have lacked enough~     statistical power and have been carried out in North America and Europe.~      The Juntos Santiago is a cluster-randomized trial based on a gamification strategy conducted~     in Santiago de Chile. The trial uses elements of a game such as points, levels and rewards~     along with a strong community participation component.~      Children voted their enrollment and collectively chose the rewards (two per year, one~     activity and another structural) they are playing for. The intervention consists of a healthy~     snacks challenge, a steps challenge and an activity challenge. The primary outcome is change~     in z-BMI and waist circumference.~   "
8183|NCT03459729|"~     A Window of Opportunity Clinical Trial. This study design permits examination of effects of~     an oral agent on cancer patients during the window between diagnosis of their cancer and~     their definitive cancer surgery. Similar to a phase 0 study, the trial design permits~     examination of the biologic effects of an agent; in this study pharmacokinetic properties~     will be examined.~   "
8184|NCT03459716|"~     Systemic sclerosis (SSc, AKA scleroderma) is an autoimmune condition characterized by~     endothelial damage and progressive fibrosis of the skin and internal organs. One of the~     leading causes of morbidity and mortality in patients with SSc is pulmonary hypertension~     (PH), which is estimated to occur in up to 31% of high risk SSc patients. Early detection of~     patients with SSc-PH may lead to improved outcomes and although there have been concerted~     efforts to accurately screen for SSc-PH, these patients continue to present with advanced~     disease and suffer from poor survival. Therefore, better methods to screen for patients with~     PH and, perhaps more importantly, to screen for those at risk for PH development are~     desperately needed. Since PH and SSc are disorders originating from the endothelium,~     biomarkers that reflect endothelial damage are very promising tools to identify early~     disease. Such potential biomarkers include endothelial microparticles, asymmetric~     dimethylarginine (ADMA), pentraxin-3, and soluble endoglin. No previous study has used a~     combination of these biomarkers to detect the presence of PH in patients with SSc, or studied~     the novel concept of exercise-induced changes in biomarker levels. The investigators will~     collect the above listed endothelial biomarkers before and after exercise, and combine these~     levels with exercise echocardiogram findings, and routine clinical information to derive a~     composite detection score for the early identification of systemic sclerosis-associated PH.~   "
8185|NCT03459703|"~     Time-restricted feeding (TRF) is a novel type of intermittent fasting that involves eating~     within a daily period of 10 hours or less, followed by fasting for at least 14 hours daily.~     Several studies in rodents report that TRF reduces body weight, improves blood sugar control,~     and reduces the risk of cardiovascular disease—even when food intake is matched to the~     control group or no weight loss occurs. Preliminary evidence suggests that TRF may also~     increase weight loss, fat loss, and reduce the risk of diabetes and cardiovascular disease in~     humans. This study will test whether TRF enhances fat loss and increases weight loss in~     adults with obesity, relative to conventional dieting alone. In addition, this study will~     determine whether TRF reduces risk factors for type 2 diabetes and cardiovascular disease and~     will measure the feasibility and acceptability of TRF.~   "
8186|NCT03459690|"~     Simple meditation and EEG changes~   "
8187|NCT03459677|"~     The main objective of this study is to examine the efficacy of a new psychological~     intervention, called Back2School, in helping youths with problematic school absenteeism to~     return to school. Furthermore, the study will examine how well this program fares against the~     treatment or interventions that are usually given to youths with school absenteeism~     (treatment as usual or TAU).~      Based on previous studies we hypothesize that the Back2School intervention will be better at~     improving levels of school attendance as compared with treatment as usual (TAU).~   "
8188|NCT03459664|"~     This study evaluates a cross sectional, severity stepped, evidence-based care model for~     patients with mental disorders (RECOVER).~      RECOVER is a consortium of well-known institutions for the treatment and integrated care of~     patients with mental disorders, patient associations, relative associations, research~     institutions, health care insurances and authorities from the care region Hamburg, Germany.~      This project aims to evaluate the RECOVER care model with treatment as usual (TAU) regarding~     cost-effectiveness (costs, efficiency and cost utility) for patients with mental disorders.~      The following questions are examined:~        1. Does RECOVER reduce psychiatric health care costs compared to TAU?~        2. Does RECOVER improve patient relevant outcomes (i.e. symptom remission, response, daily~          functioning and quality of life)?~        3. Is RECOVER cost effective compared to TAU? (from a payer's and societal perspective)~      A total sample of 1070 patients with mental disorders will be assessed at baseline (before~     treatment) and randomized into the RECOVER care model or get TAU. Follow-up assessments are~     conducted after 6 month and 12 month.~      As primary outcomes, cost reduction, improvement in symptoms (i.e. amount of remission and~     response to treatment, daily functioning and quality of life) and cost-efficiency-ratios will~     be measured. In addition, several secondary outcome parameters will be assessed.~      Impact: The present randomized controlled trial (RCT) evaluates the cross-sectional, severity~     stepped, evidence-based approach of the RECOVER model in patients with mental disorders. With~     its focus on effectiveness and cost-effectiveness, the study aims to improve the health care~     system in Germany.~   "
8189|NCT03459651|"~     This study evaluates approximate number sense (ANS) in children, adolescents, and adult women~     with Turner syndrome compared to age-matched healthy peers. One primary aim of this project~     is to assess the effectiveness of an online ANS training tool in enhancing complex~     mathematics ability. Participants will undergo weekly training sessions in their own home.~     Half of the participants will complete 2 training sessions a week for 8 weeks, and the second~     half will complete 1 training session for 8 weeks.~   "
8190|NCT03459638|"~     This study investigates the differences between subjects with and without periodontitis in:~     the prevalence of (pre)diabetes mellitus, the risk of atherosclerotic cardiovascular disease,~     the prevalence of metabolic syndrome and the risk of obstructive sleep apnea syndrome.~   "
8258|NCT03458754|"~     The primary aim of the study is to evaluate the maximal and submaximal exercise capacity in~     patients with peripheral artery disease (PAD). The secondary aim of the study is assessment~     of physical activity level, respiratory function, peripheral and respiratory muscle strength,~     respiratory muscle endurance, depression, quality of life, intermittent claudication and~     cardiovascular risk factors in patients with PAD.~   "
8259|NCT03458741|"~     Nine healthy, moderately fit male volunteers participated in the study. The subjects gave~     written informed consent after having been informed of any possible risk and discomfort~     associated with the study. The study was approved by the regional ethics committee in Denmark~     (Journal number: H-4-2013-071) and performed in accordance with the Declarations of Helsinki~     II.~      All subjects underwent 3 clinical investigations (day 1, day 2 and day 5) during a 5 day~     glycogen supercompensation regime. The subjects were asked to refrain from physical activity~     and to eat a controlled diet containing 60% carbohydrates (CHO) for 4 days prior to the~     initial experiments.~      Upon arrival at the laboratory on day 1, the subjects performed one-legged knee extensor~     exercise for 1 hour at 80% of PWL interspersed by 5 min bouts at 90% of PWL. This was~     followed by interval exercise until exhaustion containing 4 min bouts starting at 100% PWL~     followed by 1 min at 50% of PWL. Upon cessation of exercise the subjects showered and rested~     in the supine position for 4 hours. Then a 120 min hyperinsulinemic euglycemic clamp was~     initiated by a bolus insulin injection (9.0 mU/kg, Actrapid, Novo Nordisk, Denmark) followed~     by continuous insulin infusion (1.42 mU/kg/min insulin) reaching a level of plasma insulin~     around 100 µU/mL (n=9). At least 2 hours before the insulin clamp, catheters were placed in~     both femoral, one antecubital and one dorsal hand vein. A heat pad was placed around the~     lower part of the arm and hand in order to arterialize blood drawn from the hand vein.~     Substrate uptake/release across the legs was calculated by multiplying the arterial-venous~     (AV) difference in blood substrate concentration by femoral arterial blood flow (measured by~     ultrasound, Philips DICOM). Blood glucose levels were maintained at the euglycemic predefined~     target by continuously adjusting the glucose infusion rate (GIR) (20% glucose solution;~     Fresenius Kabi, Sweden). Concurrent measures of substrate AV differences and blood flow were~     performed every 20 min. Muscle biopsies from m. vastus lateralis were obtained under local~     anaesthesia (3-5 ml of Xylocaine, 20 mg/ml.) in the basal- and insulin-stimulated state (120~     min) by use of needle biopsy technique. Muscle specimen were frozen within 20 sec in liquid~     nitrogen and stored at -80°C for further analysis. A new incision was made for every biopsy~     and spaced 4-5 cm apart.~      This insulin clamp procedure in combination with basal and insulin stimulated muscle biopsies~     was repeated in the rested state (without prior exercise) on day 2 and day 5. The subjects~     arrived in the morning in the overnight fasted state at day 1, day 2 and day 5. During the 5~     day supercompensation regime the subjects were provided a predefined isocaloric diet~     containing 80% carbohydrates, 10% fat and 10% proteins. All food items were handle out to the~     subjects and compliance of the diet regime was ensured by survey.~   "
8191|NCT03459625|"~     The current study examines the efficacy of Mindfulness-Based Stress Reduction (MBSR) to~     reduce parenting stress, lessen parental reactivity and negativity, and decrease child~     externalizing behaviors among families of children with Autism Spectrum Disorder (ASD). The~     design is a randomized controlled trial of 138 families of preschool-aged children with ASD.~     Parents of children with ASD will be randomized to MBSR or to a Psychoeducational (PE)~     support control group matched for clinical contact and dosage (see details on interventions~     below). Families will participate in laboratory assessments at baseline and immediately~     post-treatment, as well as at 6 months and 12 months post-treatment. Measures include~     standardized and validated parent and teacher questionnaires, gold-standard psychological~     assessments, and observational and interview ratings.~   "
8192|NCT03459612|"~     The purpose of this study is to evaluate the effect of lasmiditan on simulated driving~     performance in healthy participants. Participants are expected to complete each of four study~     periods, which will last a total of about 10 days. During this time, participants will remain~     in the clinical research unit. Screening must be completed within 28 days before the start of~     the study. Follow-up will be completed about one week after discharge.~   "
8193|NCT03459599|"~     In some centres, women are routinely given a course of antibiotics postnatally if ragged~     placental membranes were present at delivery. The investigators examined the necessity such~     an intervention.~   "
8194|NCT03459586|"~     The purpose of this study is to determine if the 9zest app for Parkinson's disease is~     feasible, safe, and efficacious when used independently by individuals with Parkinson's~     disease.~   "
8195|NCT03459573|"~     The Fit-One trial involves three prospective, randomized waitlist-controlled studies. These~     studies evaluate the effects of One Drop's digital therapeutics solution with and without~     Fitbit devices on the social cognitive, behavioral, and health outcomes of people with~     diabetes. Fit-One is being tested on adults with type 1 diabetes (T1D) of all weights, and~     adults with type 2 diabetes (T2D) or pre-diabetes that are overweight or obese (BMI ≥ 25).~   "
8196|NCT03459560|"~     The purpose of this study is to determine the effects of a fixed dose combination of~     enalapril, hydrochlorthiazide, atorvastatin and acetylsalicylic acid (PolyPill) on primary~     and secondary prevention of cardiovascular disease in participants of Pars Cohort of Iran.~   "
8197|NCT03459547|"~     Soft tissue attachment to the implant surface serves as a biological seal preventing the~     development of inflammatory periimplant diseases (i.e. peri-implant mucositis and~     peri-implantitis).It occurs in the presence of a biomaterial during healing of the surgical~     wound that might be influence by this foreign body. Myofibroblasts represent key players in~     the physiological reconstruction of connective tissue after injury.~      This work will focus on the role of myofibroblasts during the early phases of the healing~     process in peri-implant tissues around four different abutment materials.~   "
8198|NCT03459534|"~     In a multicenter, single-arm, open-label and Phase III Radotinib clinical study, chronic~     phase Ph+ chronic myeloid leukemia patients with resistance or Intolerance to previous TKIs~     therapy including Imatinib will be recruited. In this phase 3 study, 195 subjects are~     expected to be enrolled in a single arm with the administration of Radotinib 400mg twice~     daily, which includes 20% of dropout rate.~   "
8199|NCT03459521|"~     Background: Cirrhotic patients have an increased risk of infections. In these patients is~     important to prevent hepatitis B virus (HBV) infection, as it may cause a deterioration of~     liver function. However, HBV vaccine efficacy in this group of patients is lower than in~     healthy population. Despite increasing standard doses to double doses or administering an~     accelerated pattern, the response to HBV vaccination remains suboptimal. For this reason, an~     alternative strategy may be using vaccines with novel adjuvants such as Fendrix®.~      Aim: To assess the adjuvanted HBV vaccine (Fendrix ®) efficacy in patients with chronic liver~     disease and to understand the kinetics of anti-HBs titers over time in patients who respond~     to vaccination.~      Methods: Prospective and multicenter study. Serological markers of HBV will be assessed~     prospectively in consecutive patients with non-cirrhotic liver disease (permanent abnormal~     liver blood tests > six months; elastogram ≥8 kilopascal (kPa); serum markers of fibrosis~     (APRI or FIB-4 ≥ F2); ultrasound changes suggesting chronic liver disease) and cirrhotic~     patients (diagnosed by liver biopsy and/or non-invasive methods: clinical, blood tests and~     ultrasound). Seronegative patients will receive four doses of Fendrix ® at 0,1, 2 and 6~     months. Antibodies against HBV superficial antigen (anti-HBs) will be determined at 2 months~     +/- 10 days, six months and one year after having received the fourth dose of the vaccine (to~     see kinetics). The study will differentiate between responders and non-responders to the~     vaccine: adequate immunity to HBV will be defined as anti-HBs higher than > 10mUI/mL~     (standard definition of seroconversion) and> 100mUI/mL. Investigators will evaluate the~     factors that influence the response, kinetics and safety of the vaccination in patients with~     chronic liver disease and cirrhosis.~   "
8200|NCT03459508|"~     Antiphospholipid antibody syndrome (APS) is an autoimmune disease characterized by systemic~     thrombosis and bad obstetric history. APS secondary to another medical disorder is the most~     common. Visual and ocular changes e.g. vaso-occlusive disease of retinal and choroidal~     vessels are found in patients with secondary APS. Patients with primary APS have also been~     reported to have ocular changes e.g. retinal vascular occlusion~      The aim of our study to detect prevalence of ocular changes in women diagnosed with primary~     APS and correlation of these changes with adverse obstetric outcome. If a correlation is~     present, ocular findings in women with APS could be used in the future as a predictor for~     poor obstetric outcome.~   "
8201|NCT03459495|"~     Headache affects the daily quality of life of patients. It has been reported that headaches~     may be associated with neck muscles, neck movements and trigger points in the neck Drug and~     non-drug treatments can be used today in the treatment of headaches. Various physical~     therapies are applied to cranial and cervical regions in non-drug therapies. Therapeutic~     ultrasound, Transcutaneous Electrical Nerve Stimulation (TENS), Hotpack and manipulation are~     some of them.This is a randomised placebo- controlled trial to determine the efficacy of the~     therapeutic ultrasound in the treatment of migraine.~   "
8202|NCT03459482|"~     This study is designed to evaluate the most applicable endpoints for evaluation of the~     Biomerica InFoods® IBS product.~   "
8203|NCT03459469|"~     Phase I, open-label, non-randomized study to evaluate safety of BC2059 administered~     intravenously to subjects with proven primary or recurrent desmoid tumor that is unresectable~     and symptomatic or progressive.~   "
8204|NCT03459456|"~     The investigators propose to synchronize automated measurements of behavior - head, body, and~     face dynamics, gaze, and vocal prosody - with simultaneous recordings of brain activity in~     clinically relevant contexts.~   "
8260|NCT03458728|"~     This study is designed to investigate whether the use of copanlisib is safe, feasible and~     beneficial to pediatric patients with solid solid tumors or lymphoma that are recurrent or~     refractory to standard therapy.~   "
8206|NCT03459430|"~     Core stability (CS) training is nowadays largely used in several fields, mainly to enhance~     athletic performance and to prevent and rehabilitate musculoskeletal injuries. However, in~     several experimental studies, CS training programs have not delivered as positive results as~     could be expected. The lack of proper modulation and quantification of the training load~     parameters (such as intensity, volume, frequency, etc.) may be one of the main explanations.~     Although training intensity has been manipulated by modifying the CS exercise difficulty~     through variations in mechanical constraints (i.e. participant posture, lever arms, base of~     support, unstable surfaces, etc.), to the best of the authors' knowledge no experimental~     study has quantified the CS training intensity based on objective parameters. The~     quantification of the load intensity is fundamental to analyze the dose-response~     relationships between training and CS adaptations. Therefore, the main aim of this study is~     to evaluate the effectiveness of two individualized CS training programs using smartphone~     accelerometers placed on the pelvis to quantify the intensity of several of the most common~     CS exercises employed in fitness, sports and rehabilitation. The expected effect is that the~     experimental groups will improve CS significantly.~   "
8207|NCT03459417|"~     Magnesium sulfate safety profile has been documented by histopathological analysis in~     experimental studies. magnesium sulfate added to local anesthetics decrease postoperative~     opioid requirements.~   "
8208|NCT03459404|"~     The Zalviso® Sufentanil Sublingual Tablet System (SSTS) (Grünenthal Italia, Milan, Italy) is~     a patient-controlled analgesia (PCA) system approved in September 2015 by the European~     Commission for the management of acute moderate-to-severe pain in adult patients in a~     hospital setting. This preprogrammed drug/device combination product delivers a fixed dose of~     15 mcg of sufentanil tablets as needed, in a non-invasive sublingual dosage form.~      Multimodal analgesia is defined as the administration, by one or more routes, of various~     analgesic medications with different mechanisms of action, thereby providing superior~     analgesia with fewer side effects. To improve pain control and patient satisfaction,~     patient-controlled analgesia (PCA) techniques have been developed, i.e. any delivery system~     which allows patients to self administer predetermined doses of analgesic drug to relieve~     pain. Over the past decades, intravenous (IV) PCA with morphine has been the gold standard~     for acute pain control. In our clinical practice, though, not only IV-PCA pumps were~     frequently prone to technical problems, but also patients and caregivers were not often able~     to understand or activate them, thus raising important safety issues and profoundly affecting~     the management of pain control. As a consequence, IV-PCA eventually fell into disuse,~     although no alternative has emerged until recently. The SSTS should go beyond the~     above-quoted limitations: it is a non invasive, patient-controlled and easy to use device,~     with an effective and safe opioid profile. It is, in our thinking, a promising technology.~      The aim of this retrospective analysis is to examine the role of the SSTS for management of~     pain after vertebral surgery, as part of a multimodal approach.~   "
8209|NCT03459391|"~     A double-blind, randomized, placebo-controlled, Phase I clinical study of the safety and~     tolerability of increasing doses of drug XC221 after single and repeated oral administration~     in healthy volunteers. The volunteers received the study drug once, and then continued daily~     intake for 5 days after a 6-day break. The primary objective of the study was to evaluate the~     safety and tolerability profile for drug XC221 after single and multiple administration based~     on the frequency and severity of adverse events and changes in vital signs, laboratory~     results, electrocardiography and results of the physical examination. The secondary objective~     of the study was to assess pharmacokinetics of active pharmaceutical substance XC221GI and~     its metabolite XC221A.~   "
8210|NCT03459378|"~     This clinical trial is a retrospective single-centre study. Research data will be acquired~     via patient histories stored in the hospital data system. Data of patients who received a~     Transjugular Intrahepatic Portosystemic Shunt (TIPS) at the University Hospital Graz between~     1.1.2004 and 31.12.2017 will be included into the study. The aim is to investigate the~     outcome (transplantation free survival, time to (re)occurrence of ascites, occurrence of~     hepatic encephalopathy) of patients with portal hypertension after TIPS.~   "
8211|NCT03459365|"~     The effect of Euflexxa therapy for knee osteoarthritis on levels of inflammatory and~     degenerative synovial fluid bio-markers in patients with knee osteoarthritis~   "
8212|NCT03459352|"~     The primary purpose of this pilot study is to determine the feasibility of the Noona~     Healthcare Mobile PRO Application to describe oncology patient engagement using a web-based~     symptom self-monitoring instrument. Additionally, the studyy will dentify side effects as~     well as long term or chronic adverse events during and following cancer therapy based on the~     United States (US) National Cancer Institute (NCI) Patient Reported Outcomes Common~     Terminology Criteria for Adverse Events (PRO-CTCAE), and identify patients to participate in~     future long-term Quality of Life studies following cancer therapy.~      The study is not intended to compare outcomes between groups receiving different therapies.~   "
8213|NCT03459339|"~     The goal of this research is to follow Barrett's Esophagus patients for 3 years using the~     tethered capsule endomicroscopy device with distal scanning and a compact imaging system in a~     multi-site clinical study.~   "
8214|NCT03459326|"~     According to the World Health Organization and the World Association for Sexual Health,~     sexual health is directly associated with the psychological well-being and quality of life of~     each individual.~      Infertility is a real public health problem. In recent years, there has been a clear decline~     in male fertility in industrialized countries, particularly in sperm quality. Male~     infertility may be perceived as a loss of masculinity and so men will be more reluctant to~     talk about their fertility problem than women. The studies published so far have focused on~     infertile men without any specification on the type or stage of care in Medically assisted~     procreation (MAP).~      Through our work, we propose to evaluate the impact of the type of care in Medical Assistance~     with procreation on the sexuality of man. Does the type of MAP technique used (intrauterine~     insemination, in vitro fertilization or intra cytoplasmic sperm injection) have an impact on~     male sexuality? Sexual health and reproductive health are closely linked; management of~     sexual disorders is essential to improve the quality of life. A prevention of sexual~     difficulties during the care of these patients in MAP can be set up in the MAP service from~     Clermont-Ferrand hospital.~      The main objective of our study is therefore to evaluate the perceived quality of sexuality~     by the man whose couple is engaged in a process of medical assistance to procreation.~   "
8215|NCT03459313|"~     The long-term purpose of an on-going participatory action research program The KLUB-study~     in Sweden, that involves scientists and representatives from all levels of athletics, is to~     develop a sustainable framework for safe athletics (track and field) training for child~     athletes born 2002-2006. The first part of the research program, a 1-year longitudinal study~     analysing training and injury data, was completed in November 2017. The present study sets~     out to evaluate a website that aims to support coaches and caregivers in their role as adult~     key stakeholders to foster young athletes to become adult athletes who possess the tools to~     maintain a healthy sporting lifestyle.~   "
8216|NCT03459300|"~     7 to 14 days actimetry recording in order to exclude sleep deprivation just before~     hospitalisation for differential diagnosis of hypersomnia~   "
8217|NCT03459287|"~     The objective of this study is to evaluate the efficacy and safety of RBC transfusion for~     support of acute anemia in cardiovascular surgery patients based on the clinical outcome of~     renal impairment following transfusion of red blood cells (RBCs) treated with the INTERCEPT~     Blood System (IBS) for Red Blood Cells compared to patients transfused with conventional~     RBCs.~   "
8218|NCT03459274|"~     The purpose is to study the use of virtual reality (VR) and biofeedback in rheumatology~     clinics to help manage chronic pain in patients with rheumatologic diseases. The objective is~     to know the usefulness of VR/biofeedback-based therapy in the clinic.~   "
8219|NCT03459261|"~     The present trial was aimed to identify which biomarkers could be associated in perioperative~     period after surgical treatment of tibial fracture to the development of POM.~   "
8220|NCT03459248|"~     The incidence of postoperative nausea and vomiting (PONV) after general anesthesia is up to~     30% when inhalational anesthetics are used with no prophylaxis. This makes PONV one of the~     most common complaints following surgery under general anesthesia, together with~     postoperative pain.~   "
8221|NCT03459235|"~     Total mesorectal excision and neoadjuvant radio-chemotherapy have revolutionized the~     management of rectal cancer allowing an increase in survival (between 55 and 68% at 5 years)~     and allowing a decrease of local recurrence (under 10%) and allowing to push the limits of~     sphinctyer saving procedures.~      Parallel to the oncological findings, evaluating quality of life and functionnals sequelae~     has become a priority as highlighted by the second axis of plan cancer 2014-2019.~      The prevalence of digestive functional sequelae decrease during the first two years after~     surgery. However, these results are difficult to analyse due to the heterogeneity of used~     scores in medical litterature. The low anterior resection syndrom associate poly-exoneration,~     gas and / or stool incontinence, urgency and stool splitting.~      The score of low anterior resection  LARS score  validated in Danemark in 2012 allow us to~     understand the complexity of these sequelae and to measure their impact on the quality of~     life of patients, that's why he is currently recommended.~      In the long term, almost two out of three patients suffer from this syndrom, with half of the~     patients in a severe form.~      However, its prevalence and severity are often underestimated by practitioners. It leads to~     inappropriate therapeutic measures. The aim of this study is to evaluate the impact of~     digestive and genito-urinary sequelae on quality of life from validated scores in patients~     operated curatively of rectal cancer using a population study.~      This study should include 676 patients with rectal cancer treated in calvados and alive at 2~     years of their proctectomy without local or general recurrence.~   "
8222|NCT03459222|"~     The purpose of this study is to investigate safety and anti-tumor activity of relatlimab~     combination therapy in solid cancers that are advanced or have spread~   "
8223|NCT03459209|"~     Long-chain polyunsaturated fatty acids (LCPUFAs) docosahexaenoic (DHA) arachidonic acid (AA)~     are major building blocks for the lipid bilayer of neuronal and retinal membranes and play a~     crucial role in brain and visual development. Humans lack enzymes synthetizing DHA and AA~     precursors and thus rely upon dietary sources to achieve adequate intakes. Human milk (HM)~     feeding, either own mother's milk (OMM) or donor milk (DM), is the first nutritional choice~     for preterm infants and provides appropriate LCPUFAs amounts to support neurological and~     visual development of this fragile population.~      Due to their immaturity, preterm infants are often unable to coordinate sucking and~     swallowing, thus requiring tube feeding (TF) for prolonged time periods. During TF, fatty~     acids tend to separate from aqueous milk components and to adhere to the infusion set, thus~     reducing the delivery of HM lipid contents. To dare, however, a targeted evaluation of~     TF-related LCPUFAs losses has not been performed.~      This study aims to quantitatively assess, by means of gas chromatography coupled to mass~     spectrometry, the effect of bolus and different continuous feeding methods routinely adopted~     for preterm infants' enteral nutrition on the delivery of DHA and AA contained in human milk~     samples.~   "
8224|NCT03459196|"~     The QDOT-FAST study is a prospective, multi-center, non-randomized, interventional clinical~     study.~   "
8225|NCT03459183|"~     Findings in neuroscientific research show that the environment one lives in has measurable~     effects on brain morphology and functioning. Human exposure to airborne infra- and ultrasound~     has been constantly increasing during the last decades. For instance, the European Renewable~     Energy Directive, established in 2009, lead to an increased use of wind turbines, generating~     infrasound. The EU Directive states that until 2020 a 20% of the EUs' total energy needs is~     to be generated with renewables, therefore the current infrasound load in the European~     environment will increase further. Similarly, ultrasound is ubiquitous in the modern public~     environment, emitted from public address systems, animal repellents, industrial machines,~     even toothbrushes. The present study aims to investigate potential long-term effects of~     exposure to infra- and ultrasound on subjective well-being, cognitive and brain functioning,~     as well as on brain structure. The study will apply a randomized-(placebo) controlled~     single-blind approach to investigate this subject.~   "
8226|NCT03459170|"~     Phase I, open-label, non-randomized study of safety, pharmacokinetics and efficacy of donor~     BPX-501 T cell infusion in children with recurrent or minimal residual disease (MRD)~     hematologic malignancies post-allogeneic transplant. The study will consist of the Main Study~     and an optional Pharmacokinetics (PK) Sub-Study.~   "
8441|NCT03456375|"~     Since the implantation is related with endometrial receptivity, the patient specific plasma~     progesterone concentration influences this pattern.~      Following this hypothesis, the study establishes a correlation between the serum progesterone~     measured on the day of the endometrial biopsy and the endometrial receptivity with the ERA~     test.~   "
8227|NCT03459157|"~     This demonstration project will assess the acceptability and feasibility of pre-exposure~     prophylaxis (PrEP) for men who have sex with men (MSM) as part of a comprehensive HIV~     prevention package in community-based clinics in West Africa.~      An interventional, open label, multidisciplinary and multicentre cohort study will be~     performed in Burkina Faso, Côte d'Ivoire, Mali, and Togo.~      All MSM enrolled will benefit from a comprehensive HIV prevention package including quarterly~     clinical examinations, screening and treatment of STIs, screening of HIV, PrEP (daily or~     on-demand, according the participant's choice), immunisation against hepatitis B,~     individualised peer-led support (for adherence and prevention), group discussions, condoms,~     and lubricants.~   "
8228|NCT03459144|"~     The aim of this study is to compare the outcomes of different treatment methods including~     photodynamic therapy (PDT), intravitreal ranibizumab injection (IVR) and combination therapy~     under the 1+PRN treatment regimen for polypoidal choroidal vasculopathy (PCV) and find the~     optimal treatment for PCV.~   "
8229|NCT03459131|"~     The purpose of this study is to explore overall vision with BIOFINITY® ENERGYS™ contact~     lenses as compared to BIOFINITY® contact lenses after one week of wear.~   "
8230|NCT03459118|"~     This study will evaluate pain, management of pain, behavioral symptoms, and the quality of~     staff-resident interactions between residents with and without dementia, test the~     relationship of these variables to participation in function focused care at baseline, and~     consider if there is a differential impact of FFC-AL-EIT between those with and without~     dementia with regard to participation in function focused care, functional outcomes and~     physical activity over the 12 month study period. Findings from this study will provide new~     information on how to optimize function and physical activity among older adults with~     dementia in assisted living.~   "
8231|NCT03459105|"~     Spinal anesthesia can be challenging in patients with lumbar scoliosis or previous lumbar~     spine surgery. This study aims to evaluate whether the use of the ultrasound-assisted spinal~     anesthesia reduces the number of passes required to successful dural puncture compared with~     the conventional surface landmark-guided technique in patients with abnormal spinal anatomy.~   "
8232|NCT03459092|"~     The purpose of the study is to evaluate if strabismus can be successfully treated requiring~     less surgical interventions with a Botox-based treatment regimen compared to a purely surgery~     based treatment regimen.~      Experimental arm: Botulinum toxin injection in the horizontal extraocular muscles.~      Control (active comparator) arm: Strabismus surgery on the horizontal extraocular muscles. No~     investigational product is used.~      In Switzerland the standard procedure for treating large angle esotropia is surgery, which is~     performed on the horizontal eye muscles that may be either recessed or shortened leading to~     reduced or increased muscle function respectively.~      As an alternative to strabismus surgery, botulinum toxin (Botox) can be applied in~     extraocular muscles. Botox prevents the release of acetylcholine in the synaptic cleft and~     thereby blocks the neuromuscular transmission thus inducing a palsy.~      Current evidence on the use of Botox in strabismus is incoherent, is poorly supported by~     basic research findings and leaves dedicated clinicians in the dark. The objective is to shed~     light into this field of clinical research, which may help to guide future pediatric~     ophthalmologists in their management of strabismic patients. In a best case scenario, the~     results from this trial will prevent strabismus operation for many children with acquired~     large angle esotropia.~   "
8233|NCT03459079|"~     The primary aim is to establish the safety, efficacy and mechanism of action of lanifibranor~     in patients with type 2 diabetes (T2DM) and nonalcoholic fatty liver disease (NAFLD).~     Specifically, to determine if lanifibranor decreases intrahepatic triglycerides (IHTG)~     (primary endpoint), improves hepatic insulin sensitivity, endogenous (hepatic) glucose~     production, de novo lipogenesis (DNL), HbA1c and lipid profiles. In addition, exploratory~     analysis with surrogate plasma biomarkers and imaging on liver fibrosis changes on with~     treatment will be performed.~   "
8234|NCT03459066|"~     Spasticity is part of the syndrome motor neuron following a Stroke. It is a clinical sign of~     great complexity that generates disability, limiting the function and altering the quality of~     life of the subjects, generating great impact on families and society.~      Identify times and characteristics of appearance; as well as its predictive factors can~     support an early intervention, orienting and strengthening the work of the rehabilitation~     team.~      Determine the times of establishment, location and factors that favor the development of~     spasticity in acute stage and how it influences the functionality, quality of life and~     emotional level of post-stroke patients in hospital facilities.~      Through this proposal, it is proposed to generate a new line of research that allows the~     development of scientific evidence in the area of neurorehabilitation, specifically in the~     field of spasticity, through the identification of establishment times, affected structures~     and predominant patterns in the extremities; as well as determining factors that favor the~     development of spasticity and its impact on post-stroke functionality and quality of life.~      This information will strengthen the rehabilitative process of these subjects and the actions~     of the rehabilitation team, supporting the identification of preventive measures and~     implementing effective interventions that allow achieving better motor and functional~     results, in search of an optimal recovery.~   "
8235|NCT03459053|"~     The study is a randomized controlled trial of a cognitive behavioral interventions and an~     art-based stress reduction treatment protocol (CB-ART) with 100 women, identified with~     elevated perceived stress, before undergoing IVF treatment; in order to examine its effect on~     perceived stress, plasma CFD, telomere length and pregnancy rates.~      CB-ART is a 6-session treatment protocol that has been utilized with women coping with~     stress, depression and pain and is effective in reducing these indicators, developed and~     evaluated by our research team. The treatment protocol emphasizes processing together with~     the client's recalled image, symptom or memory (ISM) pertaining to a current distressing~     mental or physical state. CB-ART is a multi-method model that integrates cognitive behavioral~     interventions and art-based stress reduction interventions. The innovation in this method is~     the transformation of imagined and drawn images and memories rather than solely verbally~     discussing their contents. The focus is on changing compositional elements that comprise each~     image and memory, thus providing a therapeutic venue to reframe and transform stress~     producing, recalled images and memories and reduce symptoms of perceived stress. Art making~     is beneficial for eliciting an emotional response and provides a concrete platform to conduct~     the cognitive processing that initiate change on the paper and then in the mind. Furthermore,~     the soothing qualities of interacting with art making foster and enhance behavioral~     relaxation techniques.~      Our study population, women with infertility problems, who are designated to undergo IVF~     treatment and have been identified to have elevated perceived stress scores on the Perceived~     Stress Scale (above 15) will be randomized and allocated to receive the CB-ART intervention~     tailored to reduce stress or treatment as usual.~   "
9137|NCT03447249|"~     This study will evaluate the efficacy of VX-659 in triple combination (TC) with tezacaftor~     (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for~     F508del and a minimal function mutation (F/MF subjects)~   "
8236|NCT03459040|"~     Bone marrow transplant (BMT) patients can develop graft-versus-host disease (GVHD), a serious~     and potentially fatal complication. The researchers have developed a blood test to identify~     patients most at risk for developing severe GVHD. Patients who consent to this study will~     have their blood tested up to two times after BMT to determine if they are at high risk for~     severe GVHD. The tests will be performed one week and two weeks after BMT. Patients who are~     high risk will be treated with a drug called alpha-1-antitrypsin (AAT) to see if it prevents~     the development of severe GVHD. Patients will receive 16 doses of AAT through a catheter~     placed into a blood vessel over eight weeks. AAT will be given either in the hospital or the~     outpatient clinic two times per week. Patients will be followed for the development of severe~     GVHD for up to four months from the BMT and will continue to be followed at routine clinic~     visits for up to one year after BMT.~   "
8237|NCT03459027|"~     The main purpose of this study is to evaluate the effects of an acute dose of dietary nitrate~     in the form of beetroot juice on skeletal muscle blood flow in response to dynamic knee~     extension exercise in healthy older adults. All subjects will receive active (rich in dietary~     nitrate) or placebo (devoid of nitrate) supplementation.~   "
8238|NCT03459014|"~     The aim of this study is to investigate the effect of manipulating the optic flow (OF) speed~     in 2 different virtual environments (VE) on active participation in healthy participants~     during virtual reality (VR) - enhanced robot-assisted gait(RAG).~      The second aim is to investigate the effect of two different VEs on active participation~     during RAG.~   "
8239|NCT03459001|"~     This prospective, observational study is designed to observe the use of a high calorie, high~     protein tube feed product in adults that are malnourished or at risk of malnutrition, as~     assessed by a clinician, and have been placed on a nutritional care plan which includes a~     tube feeding formula, per standard of care.~   "
8240|NCT03458988|"~     To prove the novel device is able to reliably detect pulsatility in patients with CF-VADs and~     to analyze whether pre-programmed intrinsic pulsatility of the 3rd generation CF-VADs can~     also be picked up. The study is not designed to measure blood pressure.~      Should this pilot study be successful in detecting enough pulsatility a follow-up study would~     then try to transfer the results into blood-pressure values with the help of comparators in~     order to identify an easier and more reliable method to measure BP in CF-VAD patients. .~   "
8241|NCT03458975|"~     The oscillations of ultrasound (US) contrast agent microbubbles under their activation by US~     waves engender a modulation of the permeability of biological barriers amplifying hence the~     extravasation of drugs and/or fluorescent markers through a process known as sonoporation. In~     such a way, the bioavailability of the therapeutic agent is augmented only in the area where~     US waves are focused. The objective now is to translate this therapeutic approach to the~     clinic by performing a feasibility study with the development of a therapy regime optimized~     for hepatic metastases of colorectal cancer.~      In order to demonstrate the clinical feasibility of the therapeutic approach based on~     ultrasound and microbubbles, we will focus on patients with liver metastases of colorectal~     cancer treated with monoclonal antibodies in combination with chemotherapy.~   "
8242|NCT03458962|"~     The goal of this collaborative research is to study human genomes in children with suspected~     congenital disease, multiple-congenital anomalies and/or multi-organ disease of unknown~     etiology by understanding the potential value of Whole Genome Sequencing (WGS) in~     establishing genetic diagnosis. The study will examine diagnosis rates, changes in clinical~     care as a result of a genetic diagnosis, health economics including potential~     cost-effectiveness of WGS and patient and provider experience with genomic medicine.~   "
8243|NCT03458949|"~     The main objective of this pilot study is to implement an awareness campaign for colorectal~     cancer screening in the workplace, in partnership with the staff of the occupational health~     service of one of the largest companies in Maine-Loire , and to evaluate the impact of this~     action on the participation rate of colorectal cancer screening among employees.~   "
8244|NCT03458936|"~     The RAD study is a longitudinal study to prospectively characterize the biological mechanisms~     of resilience in adolescents and young adults at risk for developing depression. The study~     will capture biomarkers from the domains of socio-demographic and clinical data, cognitive~     and psychological assessments, fluid-based biomarkers, neuroimaging and EEG. Such biomarkers~     will compose a human biosignature of resilience and identify risk factors for depression,~     contributing to effective treatment selection or may represent moderators of response or~     non-response to treatments in subjects with depression. A cohort of 1,500 participants, age~     10-24 will be recruited over a 5 year period. Participants will be followed for 10 years~     following an initial baseline visit. Study visits are conducted 4 times per year.~   "
8245|NCT03458923|"~     The study aims to compare the effect of intravitreal non steroidal anti inflammatory~     (Diclofenac) versus the standard treatment of diabetic macular edema, intravitreal anti~     vascular endothelial growth factor (Ranibizumab), measuring central macular thickness changes~     and best corrected visual acuity.~   "
8261|NCT03458715|"~     The population of type 2 diabetes increased enormously worldwide. As disease progression,~     uncontrolled type 2 diabetes patients need multiple daily insulin injections, but the risk of~     body weight gain and hypoglycemia will increase. In recent years, the newly oral~     anti-hypoglycemic agents developed, such as dipeptidyl peptidase-4 inhibitors (DPP4i) and~     sodium-glucose co-transporter 2 inhibitors (SGLT2i). The former indirectly stimulate insulin~     secretion and suppress glucagon through increase incretin. The later inhibit re-absorption of~     blood glucose in proximal renal tubule to improve hyperglycemia. According to the guideline~     published in 2017 by American diabetes Associations, if patients received premix insulin~     injections twice daily and their glycemic control can't meet the target, increase the~     frequency of injection such as basal bolus would be considered. However, it is difficult for~     some patients and it may cause more hypoglycemia and gain of body weight. Because previous~     report revealed dipeptidyl peptidase-4 inhibitors or sodium-glucose co-transporter 2~     inhibitors added to insulin resulted in better glycemic control, but there was no direct~     comparison, so we design this study to observe the efficacy of these two drugs in~     uncontrolled diabetes patient received twice daily insulin injections.~   "
8262|NCT03458702|"~     In summary, state anxiety scores indicate that both YogaFit and seated rest were effective at~     acutely reducing state anxiety post-condition, but not at preventing an induced anxiety~     responses post-exposure. However, physiological measures indicate a healthy adaptive response~     to YogaFit and rest both post-condition and post-exposure.~   "
8246|NCT03458910|"~     Previous research suggests that heart rate variability (HRV) biofeedback aimed at increasing~     HRV can reduce anxiety and stress. However, some mental quiescence practices that reduce HRV~     during the practice sessions also lead to positive emotional outcomes. Thus, it is not~     obvious that the benefits of HRV-biofeedback accrue due to increasing HRV during the session.~     An alternative possibility is that the benefits arise from engaging prefrontal control over~     heart rate. In this study, the investigators will test two possible mechanisms of the effects~     of HRV on emotional health by comparing two groups. In one group, participants will be asked~     to engage in daily training to decrease HRV using the HRV biofeedback device. In the other~     group, participants will be asked to engage in daily training to increase HRV using the HRV~     biofeedback device. This will allow analyses to pit two possible mechanisms against each~     other:~        1. Mechanism 1: engaging prefrontal control over heart rate is the critical factor that~          allows HRV biofeedback to help improve well-being. In this case, well-being should~          increase over time in both groups, as both training should engage prefrontal cortex to~          implement self-directed control over heart rate. Strengthening prefrontal control~          mechanisms may help improve emotion regulation in everyday life.~        2. Mechanism 2: increased HRV during the training sessions leads to greater functional~          connectivity among brain regions associated with emotion regulation during the high HRV~          state. In this case, improved well-being would be specifically associated with having~          time each day during which there were very high HRV states, and so improved well-being~          should be seen only in the group in which participants get biofeedback to increase HRV.~   "
8247|NCT03458897|"~     The primary purpose of this research is to determine if it is feasible to perform serial~     magnetic resonance imaging (MRI) to evaluate the amount of bone marrow cells (also called~     cellularity) and iron stores before and after bone marrow transplantation for severe sickle~     cell disease.~   "
8248|NCT03458884|"~     Post-stroke fatigue is common and negatively influences post-stroke recovery. Today, there is~     insufficient evidence how to treatment post-stroke fatigue. Our objective is to investigate~     if a structured cardiorespiratory interval training program added to the early supported~     discharge (ESD)-service results in relieved post-stroke fatigue and increased oxygen uptake.~      This is a 1:1 prospective randomized open- label trial with blinded evaluators (PROBE-design)~     of 50 participants referred to ESD with study start at 4 (±1) weeks after discharge from the~     stroke unit. The intervention group (N=25) receives a 12 week structured cardiorespiratory~     interval training program on ergometer cycle, 30-40 minutes, 3 days a week for 8 weeks. The~     cardiorespiratory interval training program comprises of 4x4 minute interval, at 70 to 80% of~     peak heart rate, interrupted by 3 minutes active recovery.~      The control group (N=25) receives usual ESD care. The primary outcome will be a shift in the~     Swedish Fatigue Assessment Scale before intervention (baseline) versus 8 weeks months after~     start of intervention in the intervention and control groups. Secondary outcomes include~     cardiorespiratory fitness, compliance, adherence and adverse events.~   "
8249|NCT03458871|"~     Determine the safety, feasibility, compliance, and efficacy of a daily home TTNS protocol in~     chronic SCI provided by self or caregiver for 4 weeks.~   "
8250|NCT03458858|"~     The primary objective of this study is to determine which components of berries improve~     glucose metabolism and increase fat oxidation in humans.~   "
8251|NCT03458845|"~     The study evaluates whether sarcopenia influences the prevalence of abdominal hernias in~     patients with cirrhosis.~   "
8252|NCT03458832|"~     The primary cause of facioscapulohumeral muscular dystrophy (FSHD), a common adult-onset~     dystrophy, was recently discovered identifying targets for therapy. As multiple drug~     companies pursue treatments for FSHD, there is an urgent need to define the clinical trial~     strategies which will hasten drug development, including creating disease-relevant outcome~     measures and optimizing inclusion criteria. This proposal will develop two new outcome~     measures and optimize eligibility criteria by testing 160 patients in 7 sites over a period~     of 18 months.~   "
8253|NCT03458819|"~     Approximately 10-11% of end stage kidney disease patients worldwide utilize peritoneal~     dialysis (PD) as their method of renal replacement therapy. Over time, the peritoneal~     membrane often undergoes anatomic and functional changes due to the process of epithelial to~     mesenchymal transition (EMT). EMT is characterized by increases in pro-inflammatory and~     pro-angiogenic cytokines. In this process, the mesothelial cells lining the peritoneal~     membrane are denuded and change their morphology to one more closely resembling fibroblasts.~     These fibroblasts invade the submesothelial zone of the peritoneal membrane resulting in~     marked fibrosis, and the pro-angiogenic cytokines cause an increase in neovascularization.~     Jointly, these processes culminate in impaired function of the peritoneal membrane and often~     limit the duration of effective PD therapy.~      In vitro studies in cultured human peritoneal mesothelial cells (HPMCs) and in vivo studies~     in rodent models of PD have demonstrated that the use of active Vitamin D receptor agonists~     or statins may attenuate this process of EMT. These are both classes of drugs that are~     commonly in use by patients on PD. The investigators goal is to determine whether either or~     both of these drugs might attenuate the process of EMT in patients performing PD.~   "
8254|NCT03458806|"~     The diagnosis of valvular heart disease (VHD), or its absence, invariably requires cardiac~     imaging. A familiar and inexpensive tool to assist in the diagnosis or exclusion of~     significant VHD could both expedite access to life-saving therapies and reduce the need for~     costly testing. The FDA-approved Eko Duo device consists of a digital stethoscope and a~     single-lead electrocardiogram (ECG), which wirelessly pairs with the Eko Mobile application~     to allow for simultaneous recording and visualization of phono- and electrocardiograms. These~     features uniquely situate this device to accumulate large sets of auscultatory data on~     patients both with and without VHD.~      In this study, the investigators seek to develop an automated system to identify VHD by~     phono- and electrocardiogram. Specifically, the investigators will attempt to develop machine~     learning algorithms to learn the phonocardiograms of patients with clinically important~     aortic stenosis (AS) or mitral regurgitation (MR), and then task the algorithms to identify~     subjects with clinically important VHD, as identified by a gold standard, from naïve~     phonocardiograms. The investigators anticipate that the study has the potential to~     revolutionize the diagnosis of VHD by providing a more accurate substitute to traditional~     auscultation.~   "
33223|NCT03132155|"~     This is a phase 2 study that will assess the efficacy of AMG 337 in subjects with advanced or~     metastatic clear cell sarcoma that contains the EWSR1-ATF1 gene fusion.~   "
8263|NCT03458689|"~     The enhanced recovery after surgery and laparoscopic approach have been proven beneficial in~     surgery of the colon. However, patients have still pain, nausea and vomiting postoperatively.~     Postoperative pain is an expected but undesirable effect after an operation. This study will~     compare Transabdominis Plane (TAP) Block and Quadratus Lumborum (QL) Block with the common~     postoperative treatment with enteral and parenteral analgesics.~   "
8264|NCT03458676|"~     The goal of this clinical research study is to learn if using advanced magnetic resonance~     imaging (AMRI) will improve the targeting of brain tumor needle biopsies compared to the~     standard targeting techniques. Researchers also want to learn how the results of the images~     and biopsies compare to each other to try to improve the way researchers and radiologists use~     AMRI images.~      This is an investigational study. The perfusion scan is not FDA approved or commercially~     available. It is currently only being used in research.~      There will be no cost to you for the advanced MRI, additional anesthesia, special pathology~     stains, and/or gene testing for this study.~      Up to 50 patients will take part in this study. All will be enrolled at MD Anderson.~   "
8265|NCT03458663|"~     In a single-blinded randomized, controlled study design we wish to examine to effect of~     Prevena + ActiV.A.C. therapy system on the postoperative healing in patients operated for~     chronic pilonidal disease using Bascoms' Cleft Lift procedure. At our department we handle~     cases from our entire region and have a decent patient volume. We have used Bascoms' Cleft~     left since 2013 and registered complications and experience wound deshisseance or prolonged~     healing in approx. 15% causing us to challange our postoperative regime.~   "
8266|NCT03458650|"~     This study is a single-center, randomized, double-blinded and placebo-controlled trial~     designed not only to assess pharmacokinetics, safety and tolerability of LXI-15028 but also~     to evaluate the pharmacokinetic characteristics of main metabolite M1 in vivo in 38 healthy~     adult Chinese subjects after receiving escalating single oral doses of 50 mg, 100 mg and 200~     mg and multiple oral doses of 100 mg of LXI-15028.~   "
8267|NCT03458637|"~     Background: Family-based lifestyle intervention programmes have been known to reduce~     overweight and improve cardiovascular risk in adolescent obesity [1]. This study was designed~     to address the gap in service provision of a family based weight management program for~     overweight and obese adolescents. The LITE (Lifestyle Intervention for obese teenagers) group~     program is a 6-month, family-based behavioural lifestyle intervention, specifically designed~     to treat obesity in adolescents 10-16 years referred to the Weight Management Clinic. The~     main principles underpinning LITE program are that parents are identified as the agents of~     change responsible for implementing lifestyle change in the family .~      Methods: The study design is a two-arm randomized controlled trial that recruited 60~     overweight and obese adolescents 10-16 year olds that attended Kandang Kerbau Women and~     Children's Hospital(KKH) weight management clinic. Adolescents with secondary cause for~     obesity are excluded. Participants are randomized to LITE program with usual care or usual~     care.~      Briefly, the LITE program involves four x 180 min weekly sessions, followed by three x 90 min~     monthly sessions, for adolescents and parents. The key aspects covered in the LITE program~     are in keeping with Health Promotion Board guidelines for the management of overweight and~     obesity and include healthy food choices and eating patterns, increasing physical activity~     and reducing sedentary behavior. The parenting aspects aim to support and increase parental~     capacity to implement and maintain the lifestyle changes. The program takes a solution~     focused approach with families identifying small changes that they would like to try each~     week instead of a child-centric approach.~      Outcome measurement are assessed at 3 and 6 months post baseline and include anthropometric~     measurements, physical activity, dietary intake, metabolic profile, improvement in positive~     parenting behaviour and measurement of family support.~      Primary outcome is change in body mass index (BMI) z-score at 6 months. Secondary aim is to~     evaluate the changes in waist-height ratio and fat percentage change and improvement in~     positive parenting behaviour.~   "
8268|NCT03458624|"~     Observational Study to Assess the Safety and Efficacy of FURESTEM-AD lnj. In moderate to~     Atopic Dermatitis~   "
8269|NCT03458611|"~     Hemispatial neglect is a post-stroke condition in which patients fail to detect stimuli~     presented on the side of space opposite to the damaged brain hemisphere (contralesional~     space). To date, there is no established effective treatment for this condition. A virtual~     reality (VR) behavioral training for the attention deficits characteristic of patients with~     hemispatial neglect was developed. Patients are stimulated in the visual and auditory~     modality to orient towards the contralesional side and are rewarded for detecting targets on~     this side in this training. In the current study the researchers aim to answer two main~     questions: 1) how feasible is a VR game-based intervention in stroke patients? and 2) what is~     the efficacy of the virtual reality game-based intervention in reducing the attention~     deficits characteristic of hemispatial neglect? To answer these questions a randomized~     partially double-blind placebo-controlled crossover study will be conducted. Two~     within-subject conditions will be compared: in the active condition patients will play a VR~     game in which multisensory stimulation is progressively presented in the neglected region~     (the location where previously presented targets were missed by the patient) and in the~     placebo condition patients will play a VR game in which the stimulation is presented in the~     center of of the VR environment. Neglect symptoms will be measured on a two-daily basis to~     establish the trend of symptom recovery through time. The hypothesis states that symptoms~     will recover more quickly when patients receive the active version of the VR intervention~     compared to the placebo version of the VR intervention.~   "
8270|NCT03458598|"~     Objectives The primary objective is to demonstrate that in patients undergoing major urologic~     surgery, Patient Controlled Analgesia (PCA) opioid consumption in the first 24 hours after~     surgery will be significantly less in patients who have had a single shot rectus sheath block~     pre-operatively in addition to a post-operative rectus sheath continuous block via surgically~     placed catheter versus those who only have post-operative rectus sheath continuous block.~     Secondary outcomes will be opioid requirement intra-operatively, Numerical Rating Scale (NRS)~     pain scores including maximum pain score in Post Anesthesia Care Unit (PACU) and score at 24~     and 48 hours, incidence and severity of nausea, number of vomiting episodes, sedation score,~     time to first bowel movement, time to first mobilization and duration of hospital stay.~   "
8271|NCT03458585|"~     This questionnaire is aimed at finding out if patients understand how much radiation they are~     being exposed to when they have a bone scan (99mTc-MDP)or an FDG PET/CT scan (18F-FDG~     PET/CT). This questionnaire is also interested in understanding if patients consider current~     leaflet information sent with appointment letter as sufficient to understand what the~     radiation dose from that scan is.~      By collecting information on how much patients are aware and understand about radiation~     exposure, we can use this information to develop better guidance for medical staff who advise~     patients as well as clearer information leaflets for patients to assist in their~     understanding.~   "
8272|NCT03458572|"~     This study aims to determine the effectiveness of using a commercially available acupuncture~     stud at the LI11 acupuncture point at reducing the severity of itch caused by intrathecal~     diamorphine in elective caesarean section.~   "
8273|NCT03458559|"~     Radium-223 chloride is an alpha-emitting radiopharmaceutical with proven survival benefit in~     patients with castration-resistant prostate cancer metastatic to bone. Beta-emitting~     radiopharmaceuticals have proven efficacy for palliating malignant bone pain. Nowadays,~     rhenium-188-HEDP is used in clinical practice for pain relief and palliative care. Several~     studies suggest that also rhenium-188-HEDP has the potential to improve overall survival. The~     purpose of this study is to investigate if treatment with rhenium-188-HEDP results in~     improvement of overall survival compared to treatment with radium-223-chloride.~   "
8274|NCT03458546|"~     This study is a phase Ib, single arm, open label clinical trial that will enroll patients~     with untreated diffuse large B-cell lymphoma (DLCBL) at moderate or high risk for poor~     outcome~   "
8275|NCT03458533|"~     This study aims to identify new morphological and quantitative magnetic imaging parameters of~     pituitary gland and sellar region in overweight and obese patient at baseline and after 3~     years, dividing patients in 3 groups (weight loss through diet and lifestyle changes, weight~     loss through bariatric surgery, no weight loss)~   "
8276|NCT03458520|"~     The purpose of this study is to compare whole body magnetic resonance (MR) imaging, whole~     body positron emission tomography (PET)/MR imaging, and (if available) PET/Computed~     Tomography (CT) imaging for the diagnosis of tumors in children and young adults.~     Sensitivities, specificities and diagnostic accuracies of the different imaging modalities~     will be compared for significant differences.~   "
8277|NCT03458507|"~     Nocturnal Non Invasive Ventilation (NIV) is the reference treatment for chronic alveolar~     hypoventilation in patients with neuro-muscular diseases. NIV can be provided by using~     different types of interfaces: Nasal masks are the most frequent type of interface used at~     home but oronasal masks are used by at least 25% of neuro-muscular patients mainly because of~     persistent unintentional mouth leaks. However, oronasal mask may cause persistent upper~     airway obstructive respiratory events because of the mechanical constraint on the chin~     induced by the traction of the straps that may push the mandible posteriorly during sleep.~      No randomized study has specifically addressed the question of the impact of type of~     interface in patients with neuromuscular diseases treated by nocturnal NIV.~      The investigators hypothesize that:~        1. the application of oronasal mask may jeopardize the pharyngeal patency in patients~          already proned to upper airway obstruction;~        2. the use of a nasal mask may improve upper airway stability and NIV efficacy while~          reducing side effects.~      Authors objective will be to compare the impact of nasal mask versus oronasal mask on NIV~     efficacy and side-effects. Eligible patients are those with nocturnal NIV and neuromuscular~     disease.~      After a scheduled hospital visit, patients willing to participate will undergo in random~     order 2 unattended nocturnal polygraphies under NIV at home: one polygraphy with nasal mask;~     one with an oronasal mask. Each polygraphy ans side effects assessment will be performed~     after one week of familiarization with each mask.~   "
8278|NCT03458494|"~     Nutrients and chemicals in food are able to regulate expression of genetic elements.~     Gene-nutrient interaction in response specific diets can increase an individual's risk,~     shifting the individual from health toward the development of chronic disease. The~     Transcription Factor 7 Like 2 (TCF7L2) gene may either put individuals at risk for or protect~     from Type 2 diabetes mellitus in the presence of certain foods. The main purpose of this~     four-week study is to examine diet-induced gene-nutrient interaction, with a focus on~     glucose, insulin, inflammation (CRP) and the plasma metabolome in individuals who have either~     the CC or the TT form of the rs7903146 single nucleotide polymorphism (SNP) (C/T) within the~     TCF7L2 gene. The (2) one-week study diets, one Mediterranean diet (MedDiet) based and the~     other low-fat based will be separated by a (1) week return to a regular habitual diet.~   "
8279|NCT03458481|"~     The safety, tolerability and antiviral activity of DAG181/SoF in treatment-naive and~     treatment-experienced patients with chronic hepatitis C virus (HCV) genotype 1 infection~   "
8280|NCT03458468|"~     The investigators propose a double-blinded randomized study evaluating the effectiveness of~     tranexamic acid in reducing postoperative swelling and haematoma formation after the Latarjet~     procedure.~      The purpose of this study is to assess the efficacy of tranexamic acid (TXA), given via~     intra-articular injection at the time of surgery in patients undergoing the Latarjet~     procedure for shoulder instability.~   "
8281|NCT03458455|"~     TREATMENT is an observational study addressing the need for knowledge and adequate diagnostic~     biomarkers in the response assessment of patients with brain metastasis. Reliable response~     assessment will be highly relevant in the coming years given the introduction of~     next-generation cancer drugs, including immunotherapy. This project uses advanced Magnetic~     Resonance Imaging (MRI) and Vessel Architecture Imaging (VAI) to better understand the~     response to traditional stereotactic radiosurgery (SRS) and immunotherapy.~      Secondary objectives include:~      In patients with brain metastases, use advanced MRI and Vessel Architectural Imaging methods~     to reveal parameters of traditional, immunotherapeutic, and anti-angiogenic therapy response.~      In patients with brain metastases, use advanced MRI and Vessel Architectural Imaging methods~     to compare results with traditional biomarkers.~      Use existing infrastructure at Oslo University Hospital to standardize therapy monitoring.~      In patients with brain metastases, use advanced MRI and Vessel Architectural Imaging methods~     to separate real tumor progression from treatment-induced pseudoprogression or radionecrosis~      In patients with brain metastases, use advanced MRI and Vessel Architectural Imaging methods~     to assess whether anti-angiogenic drugs improve delivery of chemotherapy.~   "
8282|NCT03458442|"~     This is a prospective, investigator-masked randomised controlled education-intervention trial~     of intense simulation-based surgical education plus conventional training versus a current~     six-week standard training course. The aim is to investigate whether the addition of~     simulation-based surgical education to standard training improves competence and surgical~     outcomes. All participants in the study will receive the educational intervention of the~     six-week Orbis-COS course. The intervention groups will receive this training and an~     additional element of learning and sustained deliberate practice using model eyes and~     simulation.~   "
8485|NCT03455803|"~     This study will investigate the changes in the reflux symptom index (RSI) and reflux finding~     score (RFS) among patients with obstructive sleep apnea after regular humidified CPAP~     therapy. Since these two diseases have strong associations then one may consider the possible~     benefits from therapy in between them.~   "
8283|NCT03458429|"~     1. Primary Objective~           To determine the safety and tolerability of 12 once monthly transfusions of GMFFP~          (Granulocyte - Colony Stimulating Factor (G-CSF) Mobilized Fresh Frozen Plasma harvested~          from young, healthy donors), given to older, frail individuals who are at risk due to~          unhealthy aging and who will then have a subsequent 12-month follow-up period.~        2. Secondary Objective~      To determine the efficacy in older, frail individuals of 12 once monthly transfusions of~     GMFFP (Granulocyte - Colony Stimulating Factor (G-CSF) Mobilized Fresh Frozen Plasma~     harvested from young, healthy donors), and a subsequent 12-month follow-up period, to improve~     the Immune Risk Profile, (IRP), cognitive function (MME), quality of life (OPQOL-35),~     Frailty Index (FI), associated with unhealthy aging in the treated subjects.~   "
8284|NCT03458416|"~     The objective of this study is to assess the long-term safety and tolerability of Cannabidiol~     Oral Solution (CBD) in patients with Prader-Willi Syndrome.~   "
8285|NCT03458403|"~     The aim of the study is to record and analyze endoscopist and endoscope motions to identify~     key movements in flexible endoscopy.~   "
8286|NCT03458390|"~     A prospective, single center, study to evaluate the effectiveness of the HyGIeaCare Prep when~     used in combination with the PillCam COLON; the hypothesis is that the HyGIeaCare Prep will~     be easier for the patients to tolerate, and the results will be as good as the existing oral~     preparation.~   "
8287|NCT03458377|"~     This study assesses what impact has on colonoscopy quality the implementation of a telephone~     educational intervention carried out individually on the patient in the days before the test.~     Half of the study patients will receive the educational intervention and the other half will~     not.~   "
8288|NCT03458364|"~     High flow nasal cannula (HFNC) has been shown to improve oxygenation and facilitate weaning~     in hypoxemia patients. Some clinical studies show the benefits of using HFNC in COPD~     patients, including reducing dead space and work of breathing. However, no clinical study has~     been to investigate the value of HFNC in weaning COPD patients from invasive ventilation.~     Thus, we proposed a randomized controlled trial to compare the use of HFNC and noninvasive~     ventilation (NIV) in weaning COPD.~   "
8289|NCT03458351|"~     In this study, the investigators are going to investigate the effects of remote ischemic~     preconditioning on platelet activation in patients undergoing cardiac surgery with~     cardiopulmonary bypass.~   "
8290|NCT03458338|"~     Prospective cross-sectional study at the outpatient clinic (OPC) of the Bagamoyo District~     Hospital (BDH) in Tanzania. Assessment of basic epidemiological data (Point prevalence and~     risk factors) on CKD with simple clinical, laboratory tests and the patients history. After~     informed consent blood samples are taken for complete blood count, serum creatinine, HbA1c,~     HIV-Screening, and urine samples for dipstick, urine sediment, and albumin-creatinine ratio.~     Further, office blood pressure, weight and height are taken. Further, patients history are~     asked by a questionnaire (i.e.history of infectious and cardiovascular diseases and basic~     demographic data: i.e. sex, age).~      CKD is defined as the presence of either impaired kidney function and/or albuminuria based on~     a one-time measurement.~      Primary outcome of the study are prevalence rates of CKD and the impact of non-communicable~     and communicable disorders on CKD.~   "
8291|NCT03458325|"~     The study is to evaluate the safe admission avoidance and the overall economic impact~     associated with management of worsening HF using the drug-device combination product, the~     Furoscix Infusor, outside the hospital setting in patients initially presenting to the~     emergency department.~      The study drug, Furoscix (furosemide injection 8 mg/ml), is a furosemide solution buffered to~     a neutral pH containing 80 mg/10 mL for subcutaneous administration over 5 hours via the~     Furoscix Infusor.~      The study objectives are:~        1. To evaluate differences in healthcare resource utilization and direct medical costs for~          patients treated with the Furoscix Infusor outside the hospital versus patients~          receiving intravenous furosemide for ≤ 72 hours in the hospital setting for 30 days~          post-discharge from the emergency department.~        2. To evaluate the safety of Furoscix administered outside the hospital.~        3. To evaluate and describe quality of life and patient satisfaction for patients who~          receive the Furoscix Infusor outside the hospital setting.~   "
8292|NCT03458312|"~     Patients diagnosed with high-grade gliomas (HGG) experience a complex symptom burden~     including high-levels concerns.~      As a consequence to this life-threatening disease, the rely on close contact with a~     specialized neuro-oncological team as well as support and practical assistance from their~     families. However, multidimensional burden of caregivers has been reported.~      CARES seeks to facilitate and activate the existing resources within the patient and the~     network using a new model of systematic family care approach.~      Specialized neuro-oncological nurses are responsible for an expanded area providing an~     opportunity for the nursing profession to establish a new model of nursing care. This may not~     only benefit the patients and their families but also contribute to strengthen the nurses'~     professional identity and support further development of neuro-oncological specialist team.~   "
8293|NCT03458299|"~     The goal of this research program is to implement and evaluate complementary interventions~     designed to address underage alcohol, marijuana, tobacco and other drug use and abuse among~     Native American youth residing in and around nine contiguous Indian reservations in rural~     portions of a Southern California county.~      Component 1. Motivational Interviewing (MI) Evaluations (Identified PHI). Approximately 150~     participants between 13 and 20 years of age will participate in the Motivational Interviewing~     (MI) intervention and the three follow-up assessments over an 18 month period. Questionnaires~     of youth substance use and access patterns will be by phone or self-administered using paper,~     iPad, and web-based surveys. Formal informed consent from participants 18 and older and~     assent and parental/legal guardian consent will be obtained from those participants under 18.~      Component 2. Psychoeducation (PE) Evaluations (Identified PHI). Approximately 150~     participants between 13 and 20 years of age will participate in the Psychoeducation (PE)~     intervention and the three follow-up assessments over an 18 month period. Questionnaires of~     youth substance use and access patterns will be by phone or self-administered using paper,~     iPad, and web-based surveys. Formal informed consent from participants 18 and older and~     assent and parental/legal guardian consent will be obtained from those participants under 18.~   "
9164|NCT03446898|"~     This ambispective cohort study aims to evaluate the effect of high altitudes environment on~     human's physiological and metabolic markers, specific markers of main human systems, and~     incidence rate and severity of chronic mountain sickness (CMS).~   "
8294|NCT03458286|"~     The study aims to investigate if combined modulated ultrasound and electric current~     stimulation (CUSECS) is an effective adjunctive treatment to use to treat diabetic foot~     ulcers when compared against usual care. Consenting patients with diabetic foot ulcers (DFUS)~     and meet the inclusion criteria will be randomly allocated in to either an experimental group~     or a control group. The experimental group will receive the adjunctive CUSECS treatment along~     their usual treatment for their diabetic ulcer. They will be required to attend the Diabetic~     Foot clinic in St. James's hospital twice a week for a maximum of eight weeks. The CUSECS is~     provided by attaching small electrodes around the ulcers to provide electric current~     stimulation. A probe is used on the ulcers to provide the ultrasound waves. Both aiming to~     increase the blood flow to an area to increase wound healing. The control group will be~     required to attend the diabetic foot clinic for their usual care for their diabetic foot~     ulcer once a week for a maximum for eight weeks. Once a week both groups ulcers will be~     assessed and measured and a photograph solely of the wound will be taken for documentation of~     wound healing. Wound pain as determined using the 0-10 Numeric pain rating scale will also be~     measured once a week.~      The movement in participant's ankle will be measured (flexion, extension, inversion) at the~     start and at the end of the study to see if treatment has improved its movement.~      As part of this study participants' will also be requested to fill out a SF-36 questionnaire~     at the start and at the end of the 8 week trial. This questionnaire evaluates a person's~     health related quality of life in which the research wants to see if it is affected by a~     diabetic foot ulcer. The self-efficacy of participants will also be assessed using PROMIS®~     Item Bank v.1.0 - General Self-Efficacy at the start and at the end of the 8 week trial. The~     cost of treatment for each arm will be calculated taking into account both direct (cost of~     treatments, consumables etc.) and indirect costs (loss of earnings, travel, parking etc.).~     Therefore, as part of this study, participants will be asked about mode of transport and~     transport time to and from the clinic and if their diabetic foot ulcer has affected their~     ability to work.~      Diabetic foot ulcer reoccurrence rates will be monitored in both groups by a follow up~     appointment 4 weeks after each group completes treatment or monitoring.~      Data from both groups will be examined and compared to see if CUSECS is effective in healing~     DFUs. The primary outcome of interest is wound healing and is determined by the number of~     wounds healed and the time to complete wound healing within eight weeks. All data will be~     stored confidentially.~      The study hypothesis is that there is be increased healing rates in subjects treated with~     CUSECS in combination with standard care compared to those treated with standard care alone.~      This study aims to provide evidence for continuing improvement in treatment for those~     suffering with diabetic foot ulcers.~   "
8295|NCT03458273|"~     A Retrospective Propensity Matched Study comparing:~        -  real zero fluoroscopy catheter ablation~        -  conventional fluoroscopy catheter ablation without 3D system~        -  conventional fluoroscopy catheter ablation with 3D system~   "
8296|NCT03458260|"~     This study will evaluate the efficacy of Pixantrone with rituximab, ifosfamide and etoposide~     as measured by the overall metabolic response rate after 2 cycles of treatment or at~     permanent treatment discontinuation.~   "
8297|NCT03458247|"~     The purpose of this study is to test whether a dose escalation up to 2000 mg per day of~     abiraterone acetate is feasible and lead to disease stabilization in castration-resistant~     metastatic prostate cancer patients who experience disease progression within the first 6~     months of abiraterone actetate at standard dose (1000 mg/d) and have a plasma abiraterone~     concentration below 8.5 ng/mL.~      It is a non-comparative phase 2 study in which patients will be included in two successive~     steps. Patients with mCRPC will be included in the first step and treated with standard dose~     (1000 mg/day) of ABI + prednisone /prednisolone (10 mg/d) according to the summary of product~     characteristics and monitored for trough ABI plasma level each month for 3 months.~      In the second step intrapatient ABI dose escalation (2000 mg/day) + prednisone/prednisolone~     (10 mg/d) will be realized for patients from the first step experiencing progressive disease~     within 6 months of ABI standard dose and with mean ABI plasma level during the first three~     months < 8.5 ng/mL~   "
8298|NCT03458234|"~     This study offers focal therapy for prostate cancer by using an intra-urethral~     radiotransponder temporarily placed during radiotherapy. The study aims to improve the~     risk-benefit ratio of therapy for early prostate cancer and potentially lessen symptom burden~     over time.~   "
8299|NCT03458221|"~     PROBLEM DEFINITION/OBJECTIVE: Ovarian cancer is the 5th most lethal cancer in the world due~     to the fact that tumours are detected at late stage of disease, currently without curative~     therapies at that stage. Standard therapy consists of surgery and chemotherapy. Despite this~     aggressive treatment overall five year survival is only 30%. Tumors are driven by cellular~     signal transduction (ST) pathways. Identifying activity of these pathways in cancer tissue~     can be used to choose an appropriate targeted drug. A number of targeted therapy drugs have~     become available, or are being developed that target individual ST pathways. Identification~     of the predominant ST pathway in cancer has shown to be extremely difficult. A newly~     developed reliable mRNA analysis technique (STAnalysis) is able to assess which pathway/s~     is/are active indicating which targeted therapy is deemed to be effective.~      STUDY DESIGN: A multicentre prospective cohort study. STUDY POPULATION: Patients with~     platinum-refractory/resistant or recurrent ovarian cancer.~      DIAGNOSTIC INTERVENTION & COMPARATOR: Analysis of the prevalent ST pathway and targeted~     therapy towards this pathway.~      OUTCOME MEASURES: Increase in survival.~   "
8300|NCT03458208|"~     Bioequivalence Study of 2 formulation of metformin (Metformin GEROPHARM vers. Glucophage®~     Merck )~   "
8301|NCT03458195|"~     Crohn's disease (CD), a chronic inflammatory process in intestinal segments leads to tissue~     damage. More than two thirds of CD patients need intestinal resection. Symptomatic clinical~     recurrence occurs in 60% by 10 years. The principal factors affecting postoperative~     recurrence are active smoking, penetrating disease, perianal lesions history, prior~     intestinal resection, small bowel resection extent, and prophylaxis treatment absence.~      Ileocolonoscopy within one year of surgery can predict clinical recurrence risk.~      Different therapies are proposed after surgery, to prevent post-operative recurrence :~     Thiopurines, 6-mercaptopurine (positive for clinical and endoscopic postoperative recurrence~     prevention), Anti-tumour necrosis factor therapy (anti-TNF), the most effective therapy.~      Intestinal microbiota acts as a central factor in the CD pathogenesis, and fecal stream role~     is clearly shown. Various changes in luminal flora with a possible link to local inflammation~     was also demonstrated. Bacteria associated with postoperative recurrence could be more~     pathogenic as adherent invasive E coli (AIEC), which could be a pathogen in CD through~     several mechanisms including increased mucosal colonization, adherence, replication and~     induction of TNF secretion. Alternatively, postoperative CD recurrence could be linked to a~     protective commensal species lack, such as Faecalibacterium prausnitzii.~      Microscopic inflammation occurs as early as 8 days after anastomosis in the neoterminal ileum~     mucosa. IL6, IL10 and TGFb levels, measured in neoterminal ileum early after surgery are~     associated with different rates of postoperative recurrence. It suggests cytokines~     implication in postoperative recurrence. T cells are major players in the intestinal immune~     response. The presence at time of surgery and persistence of disease inducing T cell clonal~     expansions could play an important role in post-operative recurrence.~      The main objective is to define a classification of ileal Crohn's Disease based on data~     integration on a large cohort of patients.~   "
8313|NCT03458039|"~     This study will evaluate two Train-the-Trainer implementation strategies to increase and~     better sustain the number of providers delivering evidence-based mental health services in~     low and middle-income countries (LIMC). The first strategy is the gold standard approach~     using experts to do a live training and the second is a technology based strategy.~     Evaluation will include trainer and provider competency, knowledge and fidelity, as well as~     cost effectiveness and will be relevant for diverse evidence-based practices that are not~     being scaled-up in LMIC.~   "
8576|NCT03454607|"~     To evaluate the safety and feasibility of a Foot Controlled Robotic Endoscope Enabled Robot~     (FREE) in performing functional endoscopic sinus surgery to answer the two key questions:~        1. Is the FREE robot feasible to use in patients for endoscopic sinus surgery?~        2. Is the FREE robot safe to use in patients for endoscopic sinus surgery?~   "
8302|NCT03458182|"~     Breathlessness during exertion is a major limiting factor for patients' physical capacity and~     activity. Increased exertional breathlessness often results in impaired activity, spiraling~     deconditioning and further worsening of exertional breathlessness, quality of life and~     prognosis.~      Recalled symptoms (from memory) can differ substantially from the actually experienced~     symptoms.The recall of symptom intensity is affected by several factors including the~     experienced peak intensity and the intensity at the end of the episode. This 'Peak-end-rule'~     has been reported in studies of pain, and in breathlessness in daily life and during~     exercise. A randomized trial reported that adding a time period with decreased pain at the~     end of a colonoscopy decreased the patient's recalled total pain of the event, improved their~     overall perception of the event and made them more willing to participate in similar~     procedures in the future.~      Pulmonary rehabilitation training is the first line treatment for exertional breathlessness~     and deconditioning in cardiorespiratory disease. However, the training as well as physical~     activities of daily life are often limited by the person's perception of his/her capacity,~     which is based on recalled breathlessness during exertion. The person's predicted~     breathlessness - that is, the level of breathlessness that the person predicts will occur~     during a future activity, is likely a major determinant of his/her willingness to participate~     in training as well as of the level of physical activity in daily life.~      To improve the effectiveness of cardio-pulmonary rehabilitation training and the patients'~     health status, new approaches for decreasing the perceived exertional breathlessness and~     optimize training are needed.~      The investigators hypothesize that adding a period of lower breathlessness intensity at the~     end of training might be a way to manipulate the recalled (remembered) symptom intensity~     during the training, and to improve the subject's perceived future exercise capacity and~     willingness to participate in physical exercise/ training.~   "
8303|NCT03458169|"~     People with central nervous system disorders such as spinal cord injury, stroke, cerebral~     palsy, Parkinson's disease, multiple sclerosis, etc… often have impaired lower extremity~     function that limits activities of daily life and independence. Different body-weight support~     systems have been developed to facilitate the rehabilitation process by compensating for the~     user's residual abilities. However, studies on weight-supported gait training on a treadmill~     have failed to show superiority over conventional rehabilitation programs for spinal cord~     injury and stroke. A recent study by the group around Grégoire Courtine showed that~     body-weight support systems that provide assistance only in the vertical direction disrupt~     the production of gait and balance, suggesting that current practices may even be detrimental~     for relearning to walk. For the past year, the Clinique Romande de Réadaptation (CRR) worked~     together with the G-Lab at EPFL and G-Therapeutics on a new robot platform specifically~     developed to provide adjustable trunk support along four independent degrees of freedom~     (LEAP). The investigators were able to draw on their long-term experience, which consists of~     different body weight support training systems for stroke and spinal cord injury. This~     knowledge, combined with the input of our therapists and physicians and the specific~     requirements for people with neurological/musculoskeletal disorders, has resulted in a design~     that can provide adjustable bodyweight support during over-ground locomotion, treadmill,~     stairs training, standing up and sitting down and for support during the training of~     activities of daily living.~      The scope of this study is to examine how well the robot can be used for rehabilitation~     therapy in everyday clinical practice. This includes, among other things, technical aspects~     such as the handling of the hardware, the adaptability of the robot to the patient, and the~     safety during operation (such as the fall prevention). Various patient-specific aspects will~     also be evaluated e.g. comfort, positioning, or motivation of the patient. This study also~     aims to evaluate the software with the various support modes, operating options, and the user~     interface of the LEAP.~   "
8304|NCT03458156|"~     To investigate the safety and efficacy of umbilical cord mesenchymal stem cell~     transplantation in patients with systemic lupus erythematosus (SLE) and lupus nephritis (LN).~   "
8305|NCT03458143|"~     This study evaluates the effect of the addition of ketamine to a conscious sedation protocol~     including remifentanil during oocyte retrieval. The investigators will have 2 groups with~     different target effect site concentrations, namely 150 ng/ml and 200 ng/ml.~   "
8306|NCT03458130|"~     This prospective, randomized, multicenter, double-blind, parallel group, placebo-controlled,~     dose-ranging study will evaluate the safety, tolerability, PK and PD of AG10 compared to~     placebo administered on a background of stable heart failure therapy. Screening and~     randomization will be followed by a 28-day blinded, placebo-controlled treatment period.~   "
8307|NCT03458117|"~     Evaluation of the mechanism of Action of talimogene laherparepvec (T-VEC) in patients with~     locally advanced non-melanoma skin cancer.~   "
8308|NCT03458104|"~     1. The purpose of this study is to develop a validated computational model for assessing~          normative change in these patterns in patients with vocal cord atrophy before and after~          voice therapy.~        2. This is a prospective study comparing two cohorts - patients with vocal cord~          atrophy(VCA) (G1) and healthy controls (G2). Subjects with VCA will receive a cone beam~          computed tomography (CBCT) scan with the standard laryngeal protocol before and after~          voice therapy. Healthy controls will also receive one cone beam computed tomography~          (CBCT) scan. Subjects with VCA (G1) will undergo post-therapy scans approximately 4~          weeks after completion of voice therapy treatment. Enrolled subjects will also undergo a~          video stroboscopy and acoustic/aerodynamic testing. Subjects in G1 typically have these~          procedures performed before and after voice therapy as standard of care. Participants in~          G2 (healthy controls) will have the video stroboscopy and acoustic/aerodynamic testing~          just once since they would not otherwise be scheduled to undergo voice therapy.~          Potential subjects will be between 65 and 80 years of age will be considered for the~          study if they qualify based on inclusion criteria. Potential subjects will undergo are~          pre-screening process involving an initial telephone screening.~        3. Raw data (measured and calculated) derived from this pilot study will be reported, and~          no statistical analysis will be performed. Data from specific aim 1 (G2) and specific~          aim 2 (G1) will be compared using graphical representations such as bar and dot plots.~          There is a potential for the loss of confidentiality; however, every reasonable effort~          will be made to limit breaches of privacy and confidentiality. Subjects may directly~          benefit from this study. In addition, data and conclusions derived from this study may~          help future patients regarding the effects of vocal therapy on vocal cord atrophy (VCA).~      The investigators will recruit up to 12 subjects to account for screen failures. Once 8~     eligible subjects are enrolled (4 per group), then enrollment will end.~   "
8309|NCT03458091|"~     Oxygenation with high-flow nasal cannula with 100% oxygen have now been evaluated in a number~     of studies and the data are convincing. The THRIVE technique is able to oxygenate patients~     safely and vital parameters has been shown to be stable. But it is of great importance to~     evaluate this new concept regarding other potential negative physiological aspects such as~     lung atelectasis and inflammatory stress response before implementing it into clinical~     practice.~   "
8310|NCT03458078|"~     : Pain modulation is very important after operation, particularly for women who undergo~     caesarean section. A pain-free postoperative period is essential following a caesarean~     section so new mothers may care for and bond with their neonates. The consequences of the~     improper pain management which raise the healthcare costs and prolong the recovery process.~     Intrathecal adjuvants are often administered during this procedure to provide significant~     analgesia, but they may also have bothersome side effects. Intrathecal midazolam and~     magnesium sulfate produces effective postoperative analgesia with no significant side~     effects.~      Objectives: This prospective, randomized, double-blind study was designed to compare the~     analgesic efficacy and safety of intrathecal midazolam vs. Magnesium sulfate vs plain~     bupivacaine as an adjunct to bupivacaine in pregnancy patients scheduled for elective~     caesarean section.~   "
8311|NCT03458065|"~     Implantable cardioverter defibrillator (ICD) shocks are associated with a subsequent~     increased risk of death, and an elevation of cardiac enzymes has been measured after~     defibrillation testing (DFT). The aim of our study was to investigate the association between~     S-ICD vs T-ICD shocks and acute cardiac damage in humans, as evaluated by means of sensitive~     and highly specific circulating biomarkers~   "
8312|NCT03458052|"~     The aim of this study is to gather information about knowledge, professional experience and~     attitude toward organ donation among health care professionals involved in the care of~     potential donors about the procurement process and potential lung donor management~     nationwide.~   "
8314|NCT03458026|"~     By this project, the investigators are going to try to demonstrate that to use objects~     connected to make a physical activity can have an impact on the clinical activity of the~     disease by bringing the subjects which present a spondyloarthritis to make a physical~     activity. The investigators shall show furthermore, than the use of connected objects also~     has better chances to glue the patients presenting a spondyloarthritis to a practice of~     regular physical activity that a simple recommendation.~   "
8315|NCT03458013|"~     Rationale: there is a need for psychosocial symptom management in hand therapy which has been~     understudied. Mindfulness-based interventions are used to address psychosocial symptoms in~     other settings such as chronic injury but have yet to be implemented or explored for patients~     in acute outpatient rehabilitation.~      Intervention: a supplemental mindfulness-based intervention (MBI) will be provided to the~     experimental group while the control group will receive standard care. The MBI will begin~     with an explanation of the purpose of a mindfulness, how mindfulness relates to hand therapy,~     and lead to a 20-minute guided meditation using an audio recording.~      Objectives: to establish the feasibility of providing a MBI in hand therapy and evaluate~     preliminary effects of the MBI on patients' stress, anxiety, and depression.~      Population: adult patients at an outpatient hand therapy clinic in the Los Angeles area who~     have received a traumatic injury (e.g., tendon laceration, compound fracture, finger~     amputation).~      Methodology: the study will use a mixed-methods, non-randomized, 2-group, comparative trial~     design with 40 participants in total. Quantitative data on psychosocial outcomes, including~     salivary cortisol, will be collected once a week for 4 weeks while patients are attending~     hand therapy and qualitative interviews will be conducted at the end of the study.~      Study arms: the experimental group (n = 20) will receive the MBI just before regularly~     scheduled standard care visits. The control group (n = 20) will receive only standard care.~      Outcomes: this pilot study will be used to inform a future fully powered trial on~     mindfulness-based interventions in hand therapy. Feasibility and preliminary psychosocial~     effects of MBIs will be evaluated and used to inform future work.~      Analysis: (1) A repeated measures ANOVA for intervention group, time, and time by~     intervention group effects on the psychosocial outcomes (i.e., Cortisol, Anxiety, Depression,~     and Pain Catastrophizing). (2) A descriptive qualitative process will be used to analyze~     themes in participant interview responses.~   "
8316|NCT03458000|"~     This is a multi-center randomized controlled trial examining the use of Video Capsule~     Endoscopy (VCE) to discharge low-moderate risk patients with suspected upper gastrointestinal~     bleeds (UGIB) from the Emergency Department (ED.) The investigators will enroll 100 subjects~     at 4 sites who present with signs of hemodynamically stable UGIBs and compare VCE risk~     assessment to an Active Control (AC) group who receive inpatient upper endoscopy (EGD).~   "
8317|NCT03457987|"~     The investigators seek to determine whether preoperative renal functional reserve predicts~     postoperative acute kidney injury in patients with normal resting glomerular filtration rates~     undergoing elective cardiac surgery.~   "
8318|NCT03457974|"~     The purpose of this study was to evaluate whether there are relationships between the~     salivary oxidative stress status of children with CHD directly dental caries including~     gender, age, salivary flow rate, salivary pH, salivary buffering capacity and drug intake~     such as angiotensin-converting enzyme (ACE) inhibitors. If such relationships exist, they~     might be employed to patient caries -prevention treatment.~   "
8319|NCT03457961|"~     Background:~      Epilepsy is a chronic neurological disease which affects approximately 70,000 patients in~     Hong Kong and 50 billion people worldwide. Among these patients one-third remained~     unresponsive to antiepileptic agents. Continual drug manipulation is an essential therapeutic~     option for these patients with refractory epilepsy. In particular, rational polytherapy has~     become the mainstay of treatment for the sub-group of patients who have failed two or more~     antiepileptic drugs (AEDs).~      A substantial amount of research has shown that N-methyl-D-aspartate receptors (NMDA) may~     play a key role in the pathophysiology of several neurological diseases, including epilepsy.~     Animal models of epilepsy and clinical studies demonstrate that NMDA receptors activity and~     expression can be altered in association with epilepsy and particularly in some specific~     seizure types. NMDA receptor antagonists have been shown to have antiepileptic effects in~     both clinical and preclinical studies. There is some evidence that conventional antiepileptic~     drugs may also affect NMDA receptor function.~      Aims:~      To investigate the medium to long-term effects of AMPA/NMDA receptor antagonist in an Asian~     cohort as there is a relative lack of clinical data in this population To explore the~     efficacy of AMPA/NMDA receptor antagonist in patients with partial onsets seizures that may~     secondarily generalize and the specific side effects of AMPA/NMDA receptor antagonist in~     relation to behavioral problems.~      Methods:~      A semi-prospective design is adopted to recruit patients who are indicated and started on~     AMPA/NMDA receptor antagonist aged 12 or above in Hong Kong. This study will collect~     information about demographic details, medical history and seizure information. Assessment of~     seizure frequency is based on seizure diary and interviews with family members. Physical~     examination, electrocardiogram and other medical information relevant to the follow-up of the~     patient will be collected.~   "
8320|NCT03457948|"~     This pilot phase II trial studies how well pembrolizumab and liver-directed therapy works in~     treating patients with well-differentiated neuroendocrine tumors and symptomatic and/or~     progressive tumors that have spread to the liver. Monoclonal antibodies, such as~     pembrolizumab, may interfere with the ability of tumor cells to grow and spread.~     Liver-directed therapies such as radiofrequency ablation, transarterial embolization,~     yttrium-90 microsphere radioembolization, and cryoablation may help to shrink tumors that are~     not being directly targeted. Giving pembrolizumab and liver-directed therapy may work better~     in treating patients with well-differentiated neuroendocrine tumors and symptomatic and/or~     progressive tumors that have spread to the liver.~   "
8321|NCT03457935|"~     The purpose of the study is to determine if miR200 family may serve as a biomarker of IPF.~   "
8322|NCT03457922|"~     This study is examining the impact of a therapy group for all anxiety disorders provided by~     the Stanford Department of Psychiatry and Behavioral Sciences's Psychosocial Treatment Clinic~     on anxiety symptoms, impairment, and access to quality mental health care.~   "
8323|NCT03457909|"~     The purpose of the study is to determine the safety and feasibility of the new~     technique,detachable string magnetically controlled capsule endoscopy(DS-MCE)for evaluating~     gastric and esophagus diseases.~   "
8324|NCT03457896|"~     This is a phase II trial to examine the efficacy of neratinib plus trastuzumab or neratinib~     plus cetuximab in patients with quadruple wild-type (all RAS/NRAS/BRAF/PIK3CA wild-type),~     metastatic colorectal cancer based on HER2 status (amplified, non-amplified [wild-type] or~     mutated). Patients must have confirmed quadruple wild-type (WT) genotype, via NSABP MPR-1 or~     from colonic biopsy or a metastatic biopsy taken prior to treatment, and known HER2 status.~   "
8325|NCT03457883|"~     232 women underwent transvaginal mesh repair (TVM)with /without transvaginal hysterectomy for~     symptomatic POP, including group A（accepted herniamesh polypropylene mesh， 117~     patients)；group B （underwent biological graft of cook，115 patients)；follow-ups for six months~     and one year after the surgery and a questionnaire about the life habits associated with~     relapse.~   "
8326|NCT03457870|"~     Extended bouts of periodic mastication and intermittent energy restriction (IER) may improve~     cognitive performance in the context of adult hippocampal neurogenesis in an ageing~     population. A randomised controlled parallel design trial will determine the impact of a 3~     month IER diet (2 consecutive days of very low calorie diet and 5 days of normal eating) and~     a mastication intervention (1 piece of gum chewed for 10 minutes 3 times a day) in comparison~     to a control on neurogenesis-associated cognitive measures and circulating levels of the~     anti-ageing protein Klotho.~   "
8329|NCT03457831|"~     Convulsive and Non Convulsive Status Epilepticus (SE) and Pseudo Status Epilepticus~     prospective registry.~      Data collection using a standardized form : demographic data and data related to the SE,~     including circumstances of onset, dates and times of onset and of seizure control, on-scene~     clinical findings, clinical features of the seizures, pre-hospital and hospital care~     providers, timing of antiepileptic and supportive treatments, results of etiological~     investigations, cause of SE, type and dosage of antiepileptic drugs. Dates and times of EEG~     monitoring, EEG results. Outcomes including vital status and Glasgow Outcome Scale score at~     ICU and hospital discharge, day-90 and 1-year after SE and determined based on data in the~     ICU and/or neurologist charts and/or patients phone interview.~   "
8330|NCT03457818|"~     The goal of the study is to characterize the effect of Prolia® (denosumab, AMG 162; Human~     Monoclonal Antibody to RANK, Ligand) on indices of bone strength in type 2 diabetes (T2D).~     The investigational plan involves administration of Prolia® or identical placebo for 12~     months as a randomized double-blind placebo-controlled trial in 66 T2D postmenopausal women~     assigned to Prolia® or placebo. The study will include assessment of different measures of~     bone quality: skeletal microarchitecture, including measurement of skeletal cortical pores;~     bone mineral density; bone material quality, and accumulation of advanced glycation~     endproducts (AGEs) in collagen. This information will help to determine whether Prolia®~     treatment in type 2 diabetes has skeletal benefits.~   "
8331|NCT03457805|"~     This is a pilot study assessing efficacy and safety in patients with advanced prostate~     cancer.~   "
8332|NCT03457792|"~     This is a long-term study of Abatacept in participants that only recently started to develop~     Rheumatoid Arthritis, a chronic inflammatory disorder affecting mainly joints.~   "
8333|NCT03457779|"~     The primary objective is to describe and discover new insights into the glucose, amino acid,~     and lipid metabolic dependencies of TNBC via nuclear magnetic resonance (NMR) spectroscopy~     analysis of in vivo [1,2-13C] glucose-labeled breast cancer biopsies.~      The secondary objectives are to correlate the dominant metabolic dependencies of TNBCs with~     pathologic response to preoperative chemotherapy, and with the cancers' molecular signaling~     pathways assessed via NGS and RPPA.~   "
8334|NCT03457766|"~     1. To ensure complete elimination of lesions with maximum preservation of function and~          aesthetics.~        2. To elaborate the Ultrasonographic features of skin cancers.~        3. To determine the accuracy of HIFU to assess the margins of skin lesions and its safety~          margins by histopathiological examination..~        4. To follow up the patient postoperatively for incomplete excision or recurrence by~          clinical and HIFU examination.~   "
8335|NCT03457753|"~     The primary objective of this study is to assess the safety and tolerability, with emphasis~     on the oral cavity, of ROSF (containing riluzole 50mg) in subjects with amyotrophic lateral~     sclerosis (ALS) administered twice daily for 12 weeks. Secondary objectives include (1) to~     record the subject's assessment of any difficulty taking riluzole administered as ROSF and~     any difficulty taking riluzole in the tablet formulation and (2) to record the relative~     preference, if any, of subjects and caretakers, for riluzole administered as ROSF vs. the~     riluzole tablet.~   "
8336|NCT03457740|"~     Decreased muscle mass (sarcopenia) and strength (dynapenia) are common during aging, with a~     rate of muscle mass loss that is approximately 6% per decade between 30 and 70 years of age.~     Muscle mass loss results in reduced strength and physical function (frailty), increased risk~     for falls and bone fractures, and decreased quality of life. The age-related decrease in~     testosterone plays a key role in the loss of muscle mass and strength for aging males. There~     is increasing interest in nutritional and exercise strategies to prevent aging-related losses~     in muscle mass and strength. Sexual dysfunction has a high prevalence among men (31%), and~     include erectile difficulties (10%), lack of interest in sex (9%), and inability to achieve~     orgasm (7%). There are multiple causes including low testosterone. There is growing interest~     in natural supplements, and this study will compare under double blind procedures two natural~     supplements with placebo (Men's Perfect Multi Formula and Andro Vitality) that have been~     formulated by Purity Products. The supplements contain micronutrients, plant extracts, and~     herbs, with the primary bioactives Rhaponticum carthamoides and magnesium. Rhaponticum~     carthamoides, commonly known as maral root or Russian leuzea, is a perennial herb that grows~     in South Siberia, and has been used to enhance muscular and sexual function, but more~     evidence from properly designed human trials is needed to determine both efficacy and safety.~     The purpose of this study using a randomized, parallel group design, is to evaluate the~     effect of two supplements relative to placebo on strength, serum free and total testosterone~     levels, sexual function, mood state, and quality of life compared to placebo over a 6-week~     period in 120 males.~   "
8337|NCT03457727|"~     This 2-part study will be carried out on healthy elderly subjects to evaluate relative~     bioavailability of danirixin formulations. Part A will support the selection of the~     formulation and Part B will assess food effect, bioavailability and pharmacokinetic (PK)~     profile of selected formulation from Part A. Danirixin is currently administered with food,~     therefore the investigation of food effect for the selected formulation could potentially~     enable dosing without food. Approximately 16 subjects will be included in Part A and~     approximately 24 subjects will be included in Part B. Both parts will include a screening~     phase, treatment phase with in-between washout period and a follow-up phase.~   "
8349|NCT03457571|"~     Patients with inflammatory bowel disease, such as Crohn´s disease or ulcerative colitis, have~     recurring episodes of abdominal pain, diarrhea and loss of weight. Besides this other~     clinical symptoms are possible e.g. deficiency syndromes such as iron deficiency. Iron~     deficiency usually attended by symptoms like hair loss, pale skin, loss of concentration or~     fatigue. In some cases iron deficiency can lead to neurological manifestations such as~     restless-legs-syndrome (RLS). Restless legs syndrome is a neurological disorders which is~     accompanied by substantial urge to move legs or other parts of the body and unpleasant~     sensations.~      Aim of this study is to to investigate the prevalence of RLS in patients with inflammatory~     bowel disease and furthermore evaluate the effect of iron supplementation in patients with~     iron deficiency and concomitant RLS.~   "
8577|NCT03454594|"~     This study will evaluate the effect of low level laser blood radiation applied to all~     participants in the treatment and controlling high blood pressure and high blood viscosity as~     well~   "
8338|NCT03457714|"~     In Canada the prevalence of spinal cord injury (SCI) is approximately 85,556, with incidence~     rates of traumatic and non-traumatic SCI at 1,785 and 2,286 cases per year, respectively.~     Common secondary health conditions experienced by individuals with SCI include psychological~     distress and pain. Appropriate management of these secondary conditions, through a~     multidisciplinary approach, is imperative as they have been shown to contribute to slower~     recovery, increased negative outcomes, and greater rates of rehospitalizations and health~     care utilization. However, resource limitations can restrict the ability of service providers~     to deliver these integrative biopsychosocial approaches in the community. In Canada over 37%~     of individuals with SCI expressed a need for emotional counselling; of these, only 43% felt~     that these needs were met. Transportation can also be a significant issue for persons with~     SCI, with 87% and 73% respectively expressing a need for short- and long-distance~     transportation. Guided internet delivered cognitive behavioural therapy (ICBT) program offers~     an alternative approach for psychosocial service delivery in the community. The program~     provides online structured self-help modules based on the principles of cognitive behavioural~     therapy (CBT) in combination with guidance from a coach through weekly emails and telephone~     calls. ICBT has shown to have a greater reduction in levels of anxiety and depression post~     treatment compared to a waitlist control group, and these levels were maintained at both 3~     and 12 month follow-ups. ICBT was shown to have similar effects to face-to-face CBT. These~     studies demonstrate that guided ICBT is a safe and effective alternative to face-to-face~     interventions and it may be beneficial for under serviced populations. Hence, examination of~     its effectiveness is warranted in the SCI population which faces various psychological and~     somatic secondary issues. Participants with SCI will receive a 8 week guided ICBT program~     called the Chronic Conditions Course for persons with SCI. The program is completed over 8~     weeks with once a week guidance from a coach. The guided course consists of five lessons, Do~     It Yourself activities, and case vignettes adapted from persons with SCI. The course also~     provides guidance and resources on other essential skills for persons with SCI, including~     communicating with health care professional, managing chronic pain, and sleep hygiene.~     Psychosocial outcomes will be assessed at baseline, 8 weeks, and at 3 months. Data on~     intervention usage and satisfaction measures will also be examined through a qualitative~     interview. Caregivers of participants will be asked to complete self-report measures and a~     qualitative interview regarding their caregiver burden.~   "
8339|NCT03457701|"~     Daprodustat administration has the potential, by virtue of increasing hypoxia-inducible~     factor (HIF) levels, to increase oral iron absorption and incorporation into hemoglobin~     (Hgb). Therefore, the purpose of this study is to compare the effect of daprodustat to rhEPO~     (i.e., epoetin alfa or darbepoetin alfa) on non-heme oral iron absorption using stable~     isotopic iron (57Fe and 58Fe) by measuring incorporation of iron in erythrocytes. This study~     will be a randomized, repeat dose, open label, two period cross-over study in adult, male and~     female subjects with anemia associated with chronic kidney disease who are not on dialysis~     currently treated with stable doses (<=50% change in 4-weekly dose) for at least 8 weeks~     prior to and including the screening period, of rhEPO (i.e., epoetin alfa or darbepoetin~     alfa). Sufficient subjects will be enrolled such that at least 12 subjects comprise the~     Evaluable Population. The study will compare the fractional iron absorption between treatment~     arms (daprodustat and rhEPO [i.e., epoetin alfa or darbepoetin alfa]) and will evaluate the~     difference is equal/not equal to zero. Approximate duration of study participation will be up~     to 73 days.~   "
8340|NCT03457688|"~     The study aims to confirm the effectiveness of chicory-derived prebiotic inulin-type fructans~     on the reduction of the number of febrile infections diagnosed by the paediatrician in~     children.~   "
8341|NCT03457675|"~     This research study is for participants that have been diagnosed with intractable Obsessive~     -compulsive disorder (OCD). OCD is a persistent and oftentimes disabling disorder marked by~     unwanted and distressing thoughts (obsessions) and irresistible repetitive behaviors. OCD~     affects 2-3% of the US population, and is responsible for substantial functional impairment~     and increased risk of early death.~      The only established first-line treatments for OCD are cognitive-behavioral therapy (CBT)~     with exposure/response prevention and certain medications. About 30-40% of patients fail to~     respond and few experience complete symptom resolution. Up to 25% of patients have difficulty~     tolerating CBT and the risk of relapse after therapies remains large. For the most severe~     cases, neurosurgery (surgery in the brain), has long been the option of last resort.~      In this study the investigators want develop an adaptive Deep Brain Stimulation (aDBS) system~     to use in subjects with intractable (hard to control) OCD. Deep brain stimulation remains~     investigational for OCD patients and is not considered standard therapy. DBS involves the~     surgical implantation of leads and electrodes into specific areas of the brain, which are~     thought to influence the disease. A pack implanted in the chest, called the neurotransmitter,~     keeps the electrical current coursing to the brain through a wire that connects the~     neurotransmitter and electrodes. It is believed deep brain stimulation may restore balance to~     dysfunctional brain circuitry implicated in OCD. The goal of this study is to enhance current~     approaches to DBS targeting in the brain and to use a novel approach to find a better and~     more reliable system for OCD treatment.~      Phase Ia is to gather data to eventually develop a prototype adaptive DBS system for~     intractable OCD that uses signals from the brain to automatically adjust the DBS stimulation~     factors. The overall goal is to improve symptom management and reduce stimulation-induced~     behavioral side effects.~   "
8342|NCT03457662|"~     The purpose of this trial is to evaluate the safety and efficacy of sonodynamic therapy (SDT)~     in reducing atherosclerotic plaques inflammation and increasing peak walking time (PWT) among~     peripheral artery disease (PAD) patients with symptom of intermittent claudication.~   "
8343|NCT03457649|"~     A phase 1 study in healthy volunteers (female and male) to evaluate through SAD and MAD, the~     safety, PK, PD and immunogenicity of ARGX-113 administered intravenously.~   "
8344|NCT03457636|"~     This is a single-center, open label pilot study. The study is comprised of 5 study visits;~     Screening, Baseline, and weeks 4, 8, and 12. All subjects will receive Oracea once daily (QD)~     and Epiduo Forte at Baseline. We will evaluate Investigator Global Assessment (IGA), total~     lesion count, inflammatory lesion count, non-inflammatory lesion count, adverse events and~     concomitant medications.~   "
8345|NCT03457623|"~     The goal of this study is to evaluate the health and social benefit of innovative management~     - IsereADOM - versus conventional follow-up in patients with heart failure.~      There is a medico-economic goal too, is to perform a cost-utility analysis of the service~     bundle (IsereADOM) versus conventional 6-month community-based follow-up in a population with~     heart failure.~   "
8346|NCT03457610|"~     Speech and language intervention (speech therapy) is one of the few methods which seem to be~     useful in management of persistent chronic cough. This method has not been available for~     patients with cough in Poland so far.The aim of the study is to implement speech therapy to~     the management plan of patients with difficult-to-treat chronic cough and to analyze its~     efficacy in this particular group.~      Patients with difficult-to treat chronic cough will be offered speech and language~     intervention as an added therapy. The effectiveness of speech therapy will be measured by~     changes in cough severity, its influence on quality of life and cough challenge test before~     and after speech therapy measured in every patient.~   "
8347|NCT03457597|"~     This is an open-label, single-sequence, 3-period crossover study conducted in healthy~     subjects. Eligible subjects will participate in a single treatment period, in which they will~     receive the following treatments: Day 1, single doses of midazolam and metoprolol; Day 2,~     single doses of pioglitazone, tolbutamide, and omeprazole; Days 5 to 17, daily doses of~     relacorilant; Day 14, single doses of midazolam and metoprolol (with relacorilant); and, Day~     15, single doses of pioglitazone, tolbutamide, and omeprazole (with relacorilant).~   "
8350|NCT03457558|"~     Food security is one's ability to get food. Individuals with a Spinal Cord Injury (SCI) have~     many risk factors for low rates of food security. Some of these risk factors include lower~     levels of income and employment. Our long-term goal is to identify if food security is more~     prevalent in the SCI population, and to develop ways to improve food security in the SCI~     population. The purpose of this study is to determine the rates of food insecurity in a~     sample of people living with a SCI and to identify some perceptions of barriers to healthy~     eating in the SCI population.~   "
8351|NCT03457545|"~     In this pilot project, 35 lung transplant candidates will be recruited to participate in a~     three month individualized home-based program focused on exercise and nutrition optimization.~     This pilot is designed to assess the feasibility of treating frailty before lung~     transplantation. Participants will complete a 1 day in-person assessment and training session~     that will include baseline frailty assessment, determination of exercise capacity, and a~     determination of nutritional status. Based on American Thoracic Society Guidelines and a diet~     evaluation by a registered dietician, information gathered during the assessment will be used~     to develop a tailored prescription for exercise and nutrition to be continued at home.~     Participants will also be taught self-management skills specific to control of dyspnea,~     fatigue, motivation, and support. Participants will receive training in protocol~     implementation at home by a coordinator trained in principles of behavior change, adult~     learning theory, and dyspnea control techniques. Subjects will be provided tablet computers~     with an app called Aidcube preloaded and taught how to interface with the app. Aidcube is a~     commercially available exercise platform designed for patients with lung and heart diseases.~     It was designed with the input of physicians, physical therapists, respiratory therapists,~     nutritionists who specialize in patients with lung and heart disease and adheres to~     professional society guidelines for exercise and rehabilitation in patients with lung~     disease. Subjects will then adhere to a individually tailored home exercise and nutrition~     program based on their exercise capacity. Aidcube allows clinicians (or in this case the PI~     and co-PI) the ability to design a customized program of exercises and diet plan through the~     provider interface. The subjects interacts with the patient interface to complete their~     exercise program during the 8 week study intervention.~      This goal of this pilot project is to determine the feasibility of implementing a home-based~     exercise and nutrition program with patients with advanced lung disease awaiting lung~     transplantation.~      Information on Aidcube can be found at https://www.aidcube.com.~      The overarching aim of this pilot study is preparatory investigation to evaluate the~     feasibility of performing a home-based intervention to treat frailty in lung transplant~     candidates.~      Specific aims:~        -  Establish a sampling time frame and recruitment techniques.~        -  Assess willingness to participate~        -  Assess adherence and compliance.~        -  Identify logistical problems in the in-person and at-home components of the intervention~        -  Determine the resources needed for a full-scale study.~        -  Provide funding bodies evidence that research team is competent and knowledgeable.~        -  Provide funding bodies that the study is feasible~   "
8352|NCT03457532|"~     This is a Phase 1a/1b multi-center and open label study to evaluate the safety, tolorability,~     pharmacokinetics and priliminary efficacy of SCC244 in advanced solid tumors patients with~     c-MET alteration~   "
8353|NCT03457519|"~     The primary objective of this study is to estimate the impact of a self-monitoring tool~     (ChARM), used as a teaching/monitoring device, on the CHWs respiratory rate counting accuracy~     when assessing children under the age of 5 years with suspected pneumonia symptoms.~   "
8354|NCT03457506|"~     In this study, the investigators will analyze the impact of digital PET/CT on the final~     diagnostic conclusion of the scan in patients with lung cancer, breast cancer, esophageal~     cancer and a group of mescellaneous cancers.~   "
8355|NCT03457493|"~     The primary objective of this substudy is to measure the concentration and the regional brain~     distribution of activated brain microglia/macrophages using the PET ligand [18F]DPA-714 in~     participants enrolled in the UAB Neuroinflammation in PD study. The PET tracer [18F]DPA-714~     binds to the 18 kDa translocator protein (TSPO, also known as the peripheral benzodiazepine~     receptor) in the mitochondria of activated microglia/macrophages and provides a non-invasive~     measure of neuroinflammation. The amount and distribution of [18F]DPA-714 in the brain will~     be correlated to clinical data acquired through the separate ongoing Neuroinflammation in PD~     study. The primary objective of this study is to determine if patients with PD have higher~     levels of neuroinflammation than healthy controls as measured with [18F]DPA-714-PET/MRI.~   "
8356|NCT03457480|"~     Objectives:~      This 5-year project is concerned with the development and evaluation of a highly innovative~     mobile phone text messaging project designed to inform young adults about risks associated~     with conventional and emerging tobacco products. The program's results can inform the Food~     and Drug Administration's (FDA) leadership, allowing them to make decisions about the text~     messages that effectively communicate risk to young consumers.~   "
8357|NCT03457467|"~     The treatment of the patients with metastatic breast cancer remains a major problem. However,~     there is an intermediate state between the primary tumor and distant metastases called~     oligometastasis. Current research indicates that good local control of oligometastasis can be~     obtained with Stereotactic body radiotherapy (SBRT) Can not prolong the long-term survival of~     patients. Researchers believe that after SBRT treatment of patients with oligometacosis in~     breast cancer, it is necessary to explore whether the anti-angiogenic therapy targeted drug~     apatinib can reduce the occurrence of new lesions and prolong the survival of patients.~   "
8358|NCT03457454|"~     The proposed research fills a significant gap in rigorous intervention studies to eliminate~     rural-urban disparities in cancer outcomes. The persistent poverty and health disparities in~     Southern Illinois is a prime example of rural cancer health disparities. The investigators'~     approach to developing and testing the multi-level intervention will serve as a model for~     working in other rural areas.~   "
8359|NCT03457441|"~     This study evaluates the level of agreement between visual parameters tested using OdySight,~     a mobile application, and standards in office methods.~   "
8360|NCT03457428|"~     Earlier studies suggest that acoustical analysis of snoring sounds can identify obstructive~     sleep apnea (OSA). The goal of the current study is to refine and validate algorithms for OSA~     diagnosis.~   "
8361|NCT03457415|"~     The primary objective of this study is to compare Assay results to diagnoses determined by~     currently accepted standards for lung cancer detection. This will be accomplished by analysis~     of sputum samples from three cohorts including healthy Participants, high risk Participants,~     and cancer patient Participants using the Assay as developed in accordance with findings of~     bioAffinity protocol BA-001 to confirm assay results. Adjustments will be made as necessary~     to finalize Assay design for clinical trials and commercialization.~      The secondary objective of this study is to determine optimum methods for collection of~     sputum samples. Three sputum collection methods used by high risk Participants will be~     compared. Individuals at high risk for lung cancer will be assigned to one of three sputum~     collection cohorts including (1) acapella® airway assist device under medical supervision to~     obtain a single sputum sample; (2) acapella® airway assist device to obtain a sputum sample~     over a three-day period, and (3) individuals who under medical supervision will collect a~     single sputum sample assisted by nebulization of between 0.9% to 10% hypertonic saline.~     Samples will be compared to determine the optimal collection method for sample analysis by~     CyPath® Lung.~   "
8362|NCT03457402|"~     Deficits in self-control are of major public health relevance as they contribute to several~     negative outcomes for both individuals and society. For children, developing self-control is~     a critically important step toward success in academic settings and social relationships, yet~     there are few non-pharmacological approaches that have been successful in increasing~     self-control. We found in our earlier studies that self-control can be increased in~     preschool-aged children with high impulsivity by using games in which they practice gradually~     increasing wait-time for larger, more delayed rewards. We are performing this current study~     to test if this training to increase self-control can be increased using mobile app~     technology, with computerized game time being used as a reward.~   "
8363|NCT03457389|"~     The aim of this study is to investigate whether inhibition of serum prolactin levels below~     normal range during cabergoline administration may reduce the recurrence rate after drug~     withdrawal in patients with prolactinomas.~   "
8364|NCT03457376|"~     This study aimed to examine the relationship between Hand Grip Force (HGF), Maximum~     Inspiratory Pressure (PImax) and Maximum Expiratory Pressure (PEmax) in ICU tracheostomized~     patients. METHODS: All patients underwent assessment of PImax and PEmax by a membrane-type~     manometer, and for the measure of HGF an hydraulic hand dynamometer~   "
8365|NCT03457363|"~     The objective of the study is to determine whether adjunctive mask of our design (Double~     Trunk Mask - DTM) has an effect on increasing arterial pressure in Oxygen (PaO2) diagnosed~     with severe hypoxia.~   "
8366|NCT03457350|"~     This study aims to estimate if performing a small caliber office hysteroscopic cervical~     negotiation would succeed to bypass tight markedly stenotic cervix in comparison to blind~     cervical probing done under general anesthesia. Moreover, we test the impact of drawing a~     detailed diagram after this procedure on the success of ET in patients with failed mock or~     actual trials of embryo transfer (ET).~   "
8367|NCT03457337|"~     To investigate the survival benefit of first-line therapy for patients with EGFR-sensitive~     mutation-positive advanced non-squamous non-small cell lung cancer treated with S-1plus~     gefitinib versus gefitinib monotherapy~   "
8368|NCT03457324|"~     This is a multicenter, randomized, double-blind, placebo controlled clinical trial, in order~     to evaluate the efficacy and safety of Chinese Medicine JCM-16021 for diarrhea-predominant~     irritable bowel syndrome. All patients will be evaluated for study eligibility at Visits 1~     (baseline) and 2 (2 weeks). On visit 2, patients who meet the criteria will be randomly~     assigned to receive 8-week treatment of either JCM-16021 Granules or JCM-16021 placebo~     Granules. The investigators, research assistants and participants are not aware of the~     treatment assignments throughout the study. Treatment codes will only be broken after the~     completion of study. The assessments at Visit 3 (4-week post treatment) and at visit 4 (end~     of 8-week treatment) are used to measure treatment response (i.e. changes from baseline).~     Assessment at visit 5 (end of 8-week follow up) is to determine any sustained response to~     treatment. All the visits will be carried out in HKBU and CUHK clinics.~   "
8369|NCT03457311|"~     The primary objective is to determine the oral galactose single point (OGSP) cutoff values to~     discriminate subjects with different hepatic function. The secondary objective is to analyze~     the correlations between OGSP and other hepatic function assessment methods among this trial~     subjects.~   "
8370|NCT03457298|"~     The aim of the current study is to compare lateral bone augmentation using the current gold~     standard (FDBA plus resorbable collagen membrane) versus Ossix Volumax as a stand-alone~     material.~   "
8371|NCT03457285|"~     This is a pilot study to investigate the use of Salaso, a web based exercise app, to increase~     access to physiotherapy and improve physical activity in patients attending St James's~     Hospital Rheumatology for Ankylosing Spondylitis (AS). Participants will be set up on the app~     and given an individual exercise programme. All individual exercises and exercise class~     videos will be available on the app. Completion of exercises can be logged on the app and~     exercise compliance will then be monitored remotely by the physiotherapist through the Salaso~     app. The physiotherapist will have a monthly telehealth session with each participant to~     assess progress and to address any difficulties. Outcome measures will be completed at~     initial assessment and again at the end of the pilot study. This data will then be analysed~     to assess the effectiveness of the Salaso app as a treatment option for AS.~   "
8372|NCT03457272|"~     Despite systems for early detection of critical illness, 12% of patients in the emergency~     department develop clinical deterioration with an increased risk of death as a result.~      There is a need for a intervention to support the identification and clinical management of~     patients at risk of clinical deterioration earlier hospitalization. The Cincinnati Children's~     Hospital has introduced a model that systematically complements systems for early detection~     of critical illness with the assessment of patient and relatives concern, clinical intuition~     and concern of the staff. In addition, the model includes formalized organizational processes~     aimed at systematic review of risk patients and early treatment efforts. Studies from United~     States indicate that the model can lead to reduction of serious incidental events and~     increase the staff awareness of the situation. The Cincinnati model is designed for children~     and has not yet been studied in a controlled study.~      Purpose To develop and investigate the impact of a Danish patient safety model. Method A~     literature review is conducted to identify risk factors that should be included in a model~     aimed at detecting and managing clinical deterioration. A patient safety model is developed~     on the basis of the literature review and the Cincinnati model and is tested in a pilot~     study. In a controlled intervention study, the effect is investigated against severe clinical~     deterioration. The intervention is carried out at the emergency departments at Horsens~     Regional Hospital and Viborg Regional Hospital with the regional hospitals in Randers and~     Herning as control departments.~   "
8373|NCT03457259|"~     The study will evaluate the clinical efficacy of midline catheters compared to conventional~     treatment in patients with an expected intravenous therapy duration of more than 5 days.~     Patients will be randomized in a 1:1 ratio. The study will include 120 patient. Endpoints~     include insertion of CVSs, peripheral venous catheters, catheter patency and a number of~     possible complications.~   "
8374|NCT03457246|"~     Pierre Fabre Dermo-Cosmétique has commercialized a cosmetic product (D-pigment rich texture)~     for treatment of hyperpigmentation. The aim of this study is to evaluate the efficacy of~     D-pigment after laser therapy, through its action on peri-lesional areas, in obtaining better~     cosmetic effect.~   "
8375|NCT03457233|"~     Induction of ovulation cycle:~        1. Gonadotrophines is started on day 2 with HMG(merional, IBSA) ,until the day of HCG~          administration(choriomon,IBSA10000IU) with starting dose 300 to 450iu.~        2. GNRH antagonist (cetrorelix 0,25mg s.c, cetrotide, serono laboratories, Aubonne~          Switzerland) is given using flexible protocol, it is given when at least one follicle~          reaches size 14 mm to prevent premature lutenization ,until the day of hCG~          administration~        3. Ovarian ultrasound scans were performed using a 5.0-9.0 MHZ multi frequency trans~          vaginal probe (mindrayDP-5)to assess the ovarian response till the mature follicles~          reach18-20mm when hCG administration 10000 IU is given.Serum E2 level is done on day of~          HCG trigger.~        4. Trans vaginal ultrasound-guided oocyte retrieval is performed 34-36 hours after hCG~          injection~        5. Progesterone vaginal tablets (Prontogest,IBSA) are administrated 400mg twice daily as~          luteal support from the day of oocytes retrieval.~        6. Ultrasound -guided fresh embryo transfer is performed on day 2 or 3 after fertilization.~        7. Serum hCG assessment to detect pregnancy is performed at 14 days after embryo transfer~          .if positive(chemical pregnancy) ,women undergo trans -vaginal ultrasonography 2 weeks~          after, to confirm fetal pulsations as well as number of gestational sacs (clinical~          pregnancy).~        8. The implantation rate is calculated as the number of viable embryos divided by the~          number of transferred embryos multiplied by 100~   "
8376|NCT03457220|"~     AZD9291 Early Access Program (EAP) was available in Taiwan during October 2015 to September~     2016, a time period before the approval of AZD9291, to supply the unlicensed AZD9291 for the~     NSCLC patients who received at least one prior EGFR TKI therapy. At the end of September~     2016, more than 450 patients have been under AZD9291 treatment through the EAP. This~     observational study aims to evaluate the clinical benefit of AZD9291 treatment for these~     patients who were in the EAP~   "
8377|NCT03457207|"~     Under general anaesthesia, the patient is placed in the modified dorsal lithotomy position a~     10-mm umbilical trocar is inserted. A panoramic view of the pelvis was obtained together with~     full assessment of the ovarian mass(es).~      Aspiration of the cyst:~      Veress needle is inserted in the midline 2 cm above the symphysis pubis to aspirate the cyst~     under laparoscopic guidance (to guide the entry of the needle into the cyst wall & to confirm~     complete aspiration).~      Delivery of affected ovary outside the abdominal cavity:~      Classic ovarian cystectomy will be done using microsurgical techniques in which the cyst wall~     will be dissected gently and carefully from the healthy ovarian tissue followed by perfect~     haemostasis and re-fashioning of the remaining ovarian tissue using Vicryl (3-0) sutures.~      Re-introduction of the ovary to inside the abdominal cavity:~      The stitched ovary is pushed gently inside the abdominal cavity and the minilaparotomy is~     re-covered by the rubber shield (to allow re-inflation of the abdominal cavity). The ovary is~     reassessed under laparoscopic guidance to ensure perfect haemostasis and normal position of~     the ovary. Pelvic irrigation is done if needed.~   "
8378|NCT03457194|"~     This study has been designed to investigate if:~        1. BMI affects the immunogenicity of influenza and pertussis vaccines given during~          pregnancy.~        2. If pertussis vaccine co-administered with influenza vaccine impacts on the~          immunogenicity of the influenza vaccine.~        3. If BMI affects transplacental antibody transfer efficiency following maternal~          vaccinations.~   "
8379|NCT03457181|"~     The purpose of this study is to test the hypothesis that music listening during carotid~     endarterectomy administered the cervical plexus block will cause less anxiety, less pain, and~     greater patient satisfaction.~   "
8380|NCT03457168|"~     On the basis of new evidence on the relationship between achieved office blood pressure (BP)~     measurements (OBPM) and the risk of cardiovascular disease (CVD) morbidity and mortality~     documented in the SPRINT trial, the recent 2017 guidelines of the American College of~     Cardiology (ACC) and the American Heart Association (AHA) have established lower values of~     130/80 mmHg for clinic systolic BP (SBP)/diastolic BP (DBP) as new diagnostic thresholds for~     hypertension and therapeutic targets for treatment of all individuals aged ≥18 years~     regardless of age, sex, or concomitant complications including presence of diabetes, chronic~     kidney disease (CKD), or history of past CVD event. According to these guidelines, the new~     proposed ambulatory BP measurment (ABPM) thresholds for diagnosis of hypertension in adults~     are 130/80 and 110/65 mmHg for the awake and asleep SBP/DBP means, respectively. However, the~     ACC/AHA guidelines do not provide any scientific evidence documenting neither the equivalence~     between these ABPM thresholds and the 130/80 mmHg cut-off values for OBPM nor the potential~     improved CVD event-free survival time of the proposed more intensive control of ambulatory~     BP.~      Results derived from observational prospective studies consistently document that therapeutic~     BP targets in hypertensive individuals, i.e., persons at increased CVD risk, should be~     established in terms of proper control of asleep BP. To date, no prospective randomized study~     has ever before evaluated which should be the adequate therapeutic ABPM target for most~     effective reduction of CVD risk. Accordingly, the Tratamiento de Hipertensión Arterial~     Durante el Sueño study (THADEUS, i.e., Treatment of Hypertension During Sleep) has been~     designed to prospectively evaluate if intensive control of asleep SBP mean proposed by the~     new ACC/AHA guidelines (<110 mmHg) in more effective than the so far its conventional~     control (<120 mmHg) to reduce CVD morbidity and mortality in hypertensive individuals.~   "
8381|NCT03457155|"~     Atrial fibrillation (AF) is a cardiac rhythm disorder particularly common in intensive care~     patients. Some meta-analyzes report a prevalence of new onset AF ranging from 4.5% to 29.5%~     in polyvalent intensive care. In our department, a recent month-long survey showed that more~     than 30% of the patients who were unhealthy on admission suffer from an episode of new onset~     AF during their stay.~      The occurrence of AF in intensive care has a pejorative effect on the patient's outcome, and~     this through two factors. On the one hand, the decreasing of cardiac output by degradation of~     the ventricular filling in diastole time, on the other hand the FA is responsible for an~     over-risk of ischemic stroke. In fact, it has been shown that the occurrence of new onset AF~     in intensive care is associated with a higher level of severity and a higher mortality. It is~     also important to underline the medico-economic impact of this rhythmic disorder as~     complication of shock due to the frequent prescription of various anti-arrhythmic or~     anticoagulant medication.~      Various factors have been mentioned to explain the frequent occurrence of AF in shocked~     patients. The shock state, whatever its origin, is characterized by the occurrence of a~     systemic inflammatory response syndrome in which is observed a particularly important~     releasing of stress hormones and endogenous catecholamines involved in the occurrence of a~     rapid multi-organ failure without treatment. Systemic humoral elements are possibly involved~     in the occurrence of new onset AF, such as high level of inflammation that characterizes~     shock states. In addition, physiological factors such as hypoxia, hypovolemia, hyperthermia~     or ionic disorders are also implicated, but their non-systemic association with intensive~     care new onset FA suggests that humoral factors may play an important and independent role.~     Among these humoral factors, the proteins of chromogranin family particularly Vasostatin-I~     (VS-I) seem possibly involved in the genesis of AF in the aggressed intensive care patients.~     Several studies have highlighted the beneficial regulatory role of VS-I on the cardiovascular~     system, particularly in a study on a canine model Stavrakis and al. have shown the VS-I~     protective role on the FA occurrence.~      However, as has been demonstrated in a prospective study in intensive care, the rates of~     circulating VS-I were significantly higher in the most severe patients and those whose~     prognosis was the most pejorative, thus not supporting the thesis of the protective effect of~     VS-I. An explanation exists for this discrepancy: VS-I is present in two distinct forms in~     the circulating blood. In vitro work carried out within the U1121 INSERM team with has made~     it possible to highlight the coexistence of two forms of VS-1: an aggregated inactive form~     and an active disaggregated form. In our hypothesis, the inactive aggregated form would be~     predominant during the states of acute pathological aggressions such as the shock and thus~     would not exert the anti arrhythmic and cardio protector expected functions.~      The first aim of our study is therefore to confirm that the onset of new onset FA during the~     shock state is associated with a significant decrease in the VS-I plasma level in its~     monomeric form called active, even when high levels of total VS-1 are detected by ELISA in~     the plasma of patients.~      Our project is a pilot and unpublished translational work. The link between VS-I and new~     onset AF in intensive care severe patients has never been studied in vivo, and the recent~     work of the associated INSERM team provides advances in understanding the function of VS-I~     over time shock conditions. Nevertheless, our experimental hypothesis require confirmation in~     humans.~      A better understanding of the factors influencing the occurrence of cardiac arrhythmias in~     intensive care patients is a major ambition as it would be a step forward in the development~     of a preventive strategy or new treatment for the benefit of patients.~   "
8382|NCT03457142|"~     This phase II trial studies how well abatacept, ixazomib citrate, and dexamethasone work in~     treating patients with multiple myeloma that is resistant to chemotherapy. Abatacept may~     block certain proteins that are present on multiple myeloma cells that have been shown to~     protect against chemotherapy. Drugs used in chemotherapy, such as ixazomib citrate and~     dexamethasone, work in different ways to stop the growth of tumor cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. Giving~     abatacept, ixazomib citrate, and dexamethasone may work better at treating patients with~     multiple myeloma resistant to chemotherapy.~   "
8383|NCT03457129|"~     This study will aim to improve retention and tolerability by slowing the initial titration~     rate of perampanel from a standard up-titration rate of 2 week intervals to a slower~     up-titration rate consisting of 3 week intervals. Subjects will be randomized to either~     perampanel, standard titration interval rate (Group A) or perampanel, slower titration~     interval rate (Group B).~   "
8384|NCT03457116|"~     The purpose of this study is to compare the efficacy and safety of oral opiate pain~     medication vs non-steroidal ant inflammatory drugs (NSAIDs) in the treatment of postoperative~     rhinoplasty pain. This study will also evaluate potential contributing factors affecting the~     efficacy of these pain control methods. Patients will be randomized to receive either NSAIDs~     in the form of 400mg of Ibuprofen or Norco (hydrocodone 5mg- acetaminophen 325mg) to be used~     for post-operative pain. The study will then compare which is more effective in controlling~     post operative pain.~   "
8400|NCT03456908|"~     The goal of this proposal is to perform first-in-man evaluation of the imaging probe F-18~     tetrafluoroborate (BF4) as a PET imaging biomarker for expression of the human sodium/iodide~     symporter (hNIS) in tissues. .~   "
8385|NCT03457103|"~     Capnometry-Assisted Breathing Training for COPD (CATCH) is a behavioral intervention that~     aims to promote optimal, self-regulated, mindful breathing. A portable capnometer is used~     in-session to provide continuous visual feedback of Respiratory Rate (RR), End-Tidal Carbon~     Dioxide Tension (ETCO2), and breathing pattern. The tailored CATCH intervention will~     emphasize a slow, quiet, regular, nasal breathing pattern, as well as pursed lips breathing~     (PLB). CATCH is once weekly for 6 weeks, for a total of 6 sessions; each session is~     approximately 60 minutes long. The principal investigator will implement the CATCH~     intervention. The principal investigator will implement the CATCH intervention. Patients will~     use the Address Stress app on a smart phone or computer tablet as part of their home~     breathing exercises.~   "
8386|NCT03457090|"~     To determine how venoarterial extracorporeal membrane oxygenation (ECMO) affects cerebral~     blood flow velocity (CBFV) measured by transcranial doppler (TCD), to determine whether~     specific changes in cerebral blood flow velocity may be associated with neurologic injury and~     to determine modifications of CBFV after withdrawal of ECMO.~   "
8387|NCT03457077|"~     This study will examine the neural mechanisms underlying both spontaneous behavior change and~     behavior change in response to a brief intervention among problem drinkers.~   "
8388|NCT03457064|"~     The study compares two programs to increase physical activity among sedentary old persons.~     The first is a provision of a free physical activity program tailored to their abilities. The~     other combines the same free physical activity with an adherence intervention which focuses~     on social contact with others in the program and on enhancing self-efficacy.~   "
8389|NCT03457051|"~     This study allows patients to take part of the decision making between a unicompartment knee~     (partial ) or a total Knee replacement . Using the measures of a decision aid questionnaire~     which explicitly details the risks and benefits of both procedures.The study will use~     subjective (reported by patient) and objective data (which will be measured) to allow the~     determination if one option is superior to the other. Information gathered from this study~     will be used to assist future patients in selecting the surgical option that best fits their~     life style.~      A feasibility pilot study of a randomized clinical trial will help to evaluate the outcomes~     of both procedures and help shape a multicentre Canadian study.~   "
8390|NCT03457038|"~     Use Mannose Binding Lectin (MBL) as a biomarker to measure levels of Pathogen- Associated~     Molecular Patterns (PAMP) during septic shock. This will allow evaluating interest of this~     biomarker to monitor and manage a septic shock. Consecutive patients admitted for sepsis in~     Intensive Care Unit Department will be included. This biomarker will be compared to all the~     parameters monitored usually for these patients in standard care.~   "
8391|NCT03457025|"~     This is a randomized, single blinded, non-placebo controlled that will compare one group of~     Bells Palsy patients receiving the current standard of care including oral corticosteroids~     and oral antivirals against an experimental group receiving the current standard of care in~     addition to hyperbaric oxygen therapy. Outcome assessment will be based on both objective~     analyses of facial movements as well as subjective quality of life scales.~   "
8392|NCT03457012|"~     The purpose of the study is to collect information on how semaglutide works in real world~     patients. Participants will get semaglutide prescribed by the study doctor. The study will~     last for about 6 to 8 months. Participants will be asked to complete some questionnaires~     about the health and the diabetes treatment. Participants will complete these during the~     normally scheduled visits with the study doctor.~   "
8393|NCT03456999|"~     This study is being conducted to determine whether MAU868 warrants further clinical~     development for the prevention of BKV infection in kidney transplant recipients.~   "
8394|NCT03456986|"~     The proposed SBIR Phase I study tests the feasibility of PATH neurotraining for improving~     cognitive skills in older adults and, potentially, forestalling or protecting against~     cognitive decline and dementia. The feasibility of PATH neurotraining will be evaluated by~     comparing it with another cognitive training program, Brain HQ's Target Tracker, and~     ascertaining the relative advantage(s) of PATH neurotraining for enhancing cognition in older~     adults between 55 and 75 years of age whose cognition is either in the age-normative range or~     in the mild cognitive impairment (MCI) range of standardized psychometric measures. MEG/MRI~     source imaging will be used on 12 of the PATH group participants to determine whether the~     behavioral results are verified by improvements in the dorsal, attention, and executive~     control networks.~   "
8395|NCT03456973|"~     The investigators propose to build and test a supportive care software platform called Nurse~     AMIE (Addressing Metastatic Individuals Everyday) to be provided to metastatic breast cancer~     patients on Android Tablets. This program will be tested in 50 metastatic breast cancer~     patients within the Penn State Cancer Institute's 28 county catchment area. The company with~     whom the investigator will partner to develop this application is already working with~     multiple investigators at the institution (Webster Group).~   "
8396|NCT03456960|"~     The purposes of this study are to evaluate bioequivalence between a single-dose of TAK-438ASA~     tablet versus a single-dose combination of TAK-438 tablet 10 mg and aspirin enteric-coated~     tablet 100 mg in Japanese healthy adult men (Study 1), and to evaluate the effects of food on~     the pharmacokinetics of TAK-438ASA tablet in Japanese healthy adult men (Study 2).~   "
8397|NCT03456947|"~     The purpose of the study is to evaluate whether Pregabalin is safe and effective in~     stabilizing cardiovascular response to laryngoscopy and tracheal intubation of patients under~     general anesthesia.~   "
8398|NCT03456934|"~     The primary objective of this study is to investigate if consumption of lower protein formula~     can slow the rate of weight gain of formula-fed infants between 3 and 12 months of age.~     Secondary objectives include investigation into whether infant nutrition and growth have an~     impact on later risk of obesity and cardiovascular disease.~   "
8399|NCT03456921|"~     This project project will provide an effective, evidence-based intervention for advance care~     planning (ACP) to 50 underserved U.S. communities or those with poor access to healthcare~     systems due to economic, cultural or other barriers. The project will also examine 15 of the~     50 communities to learn about the unique needs of African American communities in regards to~     ACP and to assess the intervention with this population. The team includes the Hospice~     Foundation of America and a university-based research team from Penn State Milton S. Hershey~     Medical Center.~   "
8401|NCT03456895|"~     The purpose of this study is to assess subjects' perceptions of environmental conditions and~     their preferences, and to expose subjects to varied environmental conditions as well as to~     assess their perception and feedback to these conditions. Another aim of this study is to~     explore potential patterns, factors of influence, and factors of reference in relation to the~     objectively assessed quality of the imagining examination and/or the perception of the~     patient. Finally, another aim of this study is to explore the feasibility of innovative~     biofeedback response capturing methodologies and technologies to guide the design of specific~     clinical investigations or trials.~   "
8402|NCT03456882|"~     Amyotrophic Lateral Sclerosis (ALS) is a rare lethal neurodegenerative disease involving~     inflammation. Riluzole, the only drug for ALS, improves median survival by 3 months. This~     prompts new treatments of ALS. RNS60 is an experimental drug with favorable effects in~     preclinical studies of neuroinflammation and neurodegeneration. Based on significant efficacy~     demonstrated in preclinical studies and its excellent clinical safety profile, RNS60 is a~     promising candidate for a drug to treat ALS. Developing a pharmacodynamic marker will be a~     first and important step for dose finding and exploration of the mechanism of action in~     human, and pave the way to trials measuring drug efficacy.~      The Investigator propose a multicenter, randomized, double-blind, placebo-controlled,~     parallel group, Phase II trial. The study centers will be located in Italy and at~     Massachusetts General Hospital (MGH) in Boston. A total of 142 ALS patients will be randomly~     assigned to RNS60 or placebo (administered by intravenous infusion once/week and inhaled via~     nebulization every morning for 24 weeks). All participants will also take riluzole (50-mg~     tablet twice/day). Blood samples for biomarker analysis (protein, RNA) will be collected in~     the screening period, on day 1, week 4,12 and 24. Both safety and potential therapeutic~     effects of RNS60 will be also assessed.~   "
8403|NCT03456869|"~     The purpose of this study is to assess the accuracy and clinical validation of patient~     specific implants (PSI) technique for genioplasty.~   "
8404|NCT03456856|"~     This study is a prospective, single-site, open-label, single-arm intervention study in~     African-American/Black subjects with HFrEF nested in the Henry Ford Heart Failure~     Pharmacogenomics Registry, and will be conducted at the Henry Ford Health System in Detroit,~     MI.~      There will be a 7-day screening period, a 57-day open-label treatment period, and a safety~     follow-up at day 87 or 30 days after the last administration of the investigational product.~   "
8405|NCT03456843|"~     This randomized phase II trial studies how well surgical removal of the prostate and~     antiandrogen therapy with or without docetaxel work in treating men with newly diagnosed~     prostate cancer that has spread to other places in the body. Androgens can cause the growth~     of prostate cancer cells. Antiandrogen therapy may lessen the amount of androgens made by the~     body. Drugs used in chemotherapy, such as docetaxel work in different ways to stop the growth~     of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Surgery, antiandrogen therapy and docetaxel may work better in treating~     participants with prostate cancer.~   "
8406|NCT03456830|"~     The purpose of this study is to determine the efficacy and safety of ALLN-177 in patients~     with enteric hyperoxaluria.~   "
8407|NCT03456817|"~     The purpose of this study is to find out whether compared to our standard low dose ATG with~     CSA, the high dose ATG without CSA minimizes the chances of relapse and chronic GVHD, without~     increasing the chances of other transplant complications.~   "
8408|NCT03456804|"~     This phase II trials studies the side effects and how well ESK981 works in treating patients~     with castration-resistant prostate cancer that has spread to other places in the body. ESK981~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
8409|NCT03456791|"~     Endometrial cancer represents the most common gynecologic cancer, and it is expected to~     become an even greater public health concern as the prevalence of obesity, one of the most~     common risk factors for endometrial cancer, increases worldwide.~      Almost 20% of patients with endometrial cancer are in the premenopausal state and 10% are~     asymptomatic. In such a case, it is much harder to make an early diagnosis and usually they~     are probably diagnosed at advanced stages.~      An earlier diagnosis represents an imperative goal to improve survival and prognosis of~     patients of endometrial cancer. Actually, there are no certified screening tools for~     endometrial cancer. Pelvic ultrasound as screening for endometrial cancer-reaches 80.5% of~     sensitivity, when endometrial echo is > 5 mm, but it dramatically decreases to 20% in~     asymptomatic women; moreover, specificity is low (61%).~   "
8410|NCT03456778|"~     The purpose of this prospective study is to utilize a real-time ultrasound modality known as~     real-time Shear Wave Elastography (SWE) to first study the viscoelastic properties of the~     Achilles tendon to understand the functional differences between normal/asymptomatic vs~     tendinotic/symptomatic tendon states. The secondary aim will be to assess the degree of~     tendon healing after percutaneous tenotomy (a minimally invasive technique that can be used~     to treat tendinosis) and Platelet-Rich Plasma (PRP) targeting mid-substance Achilles~     tendinopathy. Utilizing a quantitative tool to assess healing response to percutaneous tendon~     fenestration and PRP injection may have significant clinical implications because it will~     provide insight into the mechanism of Achilles tendon healing.~   "
8411|NCT03456765|"~     A true estimation of gestational age (GA) plays animportant role in quality of maternity care~     such asassessment of fetal growth and to schedule the labordate. Any inaccurate estimation~     may lead to peri-natalmorbidity and mortality due to iatrogenic pre- or post-maturity .~   "
8412|NCT03456752|"~     The objective of this RCT is to determine the efficacy of a single preoperative dose of~     Dexamethasone for accelerating the recovery and reducing the incidence of postoperative~     complications in adult patients undergoing intestinal resection for inflammatory bowel~     disease.~   "
8413|NCT03456739|"~     ear swabs will be collected from 120 patients with established CSOM at the ear-nose-throat~     (ENT) outpatient clinic at the Ziv medical center, and 120 swabs will be taken from children~     with Otitis Media with Effusion (OME) undergoing elective tympanostomy tube insertion,~     serving as a control group. Ear swabs will be frozen at -80C until analysis.DNA will be~     purified from ear swabs, and amplified by PCR so that a barcoded 16S rRNA library from each~     subject will be generated. Using correlation analysis, we will compare between microbial~     compositions in chronic otorrhea patients vs. control groups.An additional ear swab will be~     collected from patients and cultured to test antibiotic resistance.~   "
8415|NCT03456713|"~     The purpose of this study is to look at the amount of the study drug, LY3074828, that gets~     into the blood stream and how long it takes the body to get rid of LY3074828, when given as a~     solution formulation in different devices. The tolerability of LY3074828 will also be~     evaluated and information about any side effects experienced will be collected.~      Screening is required within 28 days prior to the start of the study. For each participant,~     the total duration of the clinical trial will be approximately 13 weeks, not including~     screening.~   "
8416|NCT03456700|"~     This phase II trial studies how well auranofin and sirolimus work in treating participants~     with ovarian cancer. Immunosuppressive therapy, such as auranofin and sirolimus, is used to~     decrease the body?s immune response and may increase blood cell count.~   "
8417|NCT03456687|"~     The purpose of this research study is to investigate how the brain and motor behavior changes~     Parkinson's Disease (PD) over time in response to Exenatide. In previous clinical trials, PD~     patients have experienced symptomatic improvement on Exenatide and literature suggests it may~     help slow the progression of Parkinson's. Both will be evaluated in this study.~   "
8418|NCT03456674|"~     This study will evaluate the clinical outcomes associated with use of the LaseMD Laser System~     for the treatment of melasma.~   "
8419|NCT03456661|"~     A double blind prospective randomized controlled trial in which the effect of single shot~     levobupivacaine 0,25% will be compared with the effect of levobupivacaine 0.25% in~     association with dexmedetomidine when performing an ultrasound guided modified pectoral nerve~     block , in patients undergoing a mastectomy with axillar procedure.~      The difference in effect will be evaluated by monitoring the postoperative morphine~     consumption in both groups .~      Our hypothesis is that there is a significant decrease in morphine consumption during the~     first 24h postoperatively due to association of dexmedetomidine to the local anesthetic~     compared to the local anesthetic alone when performing a ultrasound guided modified pectoral~     nerve block. The morphine consumption will be our primary outcome parameter.~   "
8420|NCT03456648|"~     Apixaban is a novel oral direct factor Xa inhibitor; In patients with atrial fibrillation,~     apixaban was superior to warfarin in preventing stroke or systemic embolism, caused less~     bleeding, and resulted in lower mortality (the ARISTOTLE trial). Given its favorable outcome~     profile compared to oral vitamin K antagonists in patients with normal kidney function and in~     patients with mild to moderate kidney disease and given the potential serious side-effects of~     oral vitamin K antagonists in end-stage kidney disease, apixaban may be an attractive~     alternative for systemic anticoagulation in dialysis patients. The pharmacokinetics of~     apixaban in end-stage renal disease is not well characterized.~      The aim of the current study is to perform single dose pharmacokinetics / pharmacodynamics~     studies in patients treated with end-stage renal disease. The primary aim is to determine~     inter-dialytic pharmacokinetics of Apixaban, secondary aims are intra-dialytic~     pharmacokinetics and dose finding. Two doses of drugs will be studies (2.5 mg and 5 mg).~     Study drug will be administered at the end of a dialysis session (part A) and at the~     beginning of a dialysis session (Part B). Six (n=6) patients are scheduled to be included for~     each part and each dose.~      Anti-Xa activity values (IIU/mL) will be converted to apixaban concentration data (ng/mL).~     Apixaban concentration-time profiles will be generated and observed values for the~     descriptive PK parameters Cmax (peak plasma concentration) and time to Cmax (Tmax) will be~     determined directly from these profiles. PK profiles will be further analyzed with~     non-compartmental analysis (NCA).~   "
8421|NCT03456635|"~     To evaluate the impact of using a computerized decision program on the adequacy of the~     perioperative antimicrobial prophylaxis~   "
8422|NCT03456622|"~     A prospective , observational, multi-centre, cohort study of the G7™ Acetabular System used~     with compatible femoral stems in patients with degenerative disease of the hip.~      The study will be enrolled onto Beyond Compliance.~   "
8423|NCT03456609|"~     The efficacy and safety of cancer patients in patients with gastrointestinal cancer~     (Palliative care) in patients with gastrointestinal tumor (chemotherapy) were prospectively,~     randomized blind, multicenter clinical trials. They were randomly divided into 2 groups, test~     group Shenqifuzheng injection of 500 ml, the control group 0.9% sodium chloride injection,~     500 ml, intravenous drip, 1 times a day, 14 days post, rest is 7 days, 21 days each for a~     period of treatment, observation of two procedures. At the same time, according to the NCCN~     guide and the health ministry issued the diagnosis and treatment guidelines for cancer~     treatment. The main curative effect of the clinic was to evaluate the pretreatment of cancer~     due to the fatigue score of the patients before and after treatment -- the Piper fatigue~     revision scale was used to evaluate the Chinese version. Assess effectiveness and safety~     based on clinical assessment~   "
8424|NCT03456596|"~     The Purpose of this project is to implement ENABLE (Educate, Nurture, Advise, Before Life~     Ends) at four community cancer practices that have a high percentage of rural and/or~     medically-underserved patients diagnosed with advanced cancer and their family caregivers.~     The ENABLE principal investigator (PI) and the Coordinating Center team are located at the~     University of Alabama at Birmingham (UAB). Site teams are - Spartanburg SC/Gibbs Cancer~     Center, Birmingham VA Medical Center, University of South Alabama/Mitchell Cancer Institute,~     UAB Division of Gynecologic Oncology and UAB Department of Hematology Oncology.~   "
8425|NCT03456583|"~     The Brevera Breast Biopsy System integrates tissue acquisition, real time imaging, and post~     biopsy handling all during the same procedure. This post-market clinical trial will be~     performed to obtain clinical/operational data and feedback on the Brevera Breast Biopsy~     System.~   "
8426|NCT03456570|"~     The aim of this study is to determine whether the use of progesterone only pills has a~     beneficial effect over the expectant management of functional ovarian cyst or not , through a~     sample of female patients within the reproductive years~   "
8427|NCT03456557|"~     The investigators to establish whether early microvascular permeability parameter evaluated~     by perfusion-CT could be good biomarkers for severity in acute pancreatitis.~      Therefore the investigators want to compare 48 hours-clinico-biological systemic inflammatory~     response syndrome score to initial microvascular permeability parameters ( ktrans - capillary~     membrane permeability factor- and pancreatic blood flow ) calculated by OLEA software using~     inclusion perfusion CT.~   "
9188|NCT03446586|"~     The purpose of the registry/repository is to understand the natural history of tyrosinemia in~     our region and to provide a mechanism to store data and specimens to support the conduct of~     future research about hereditary tyrosinemia among the Arabs.~   "
8428|NCT03456544|"~     The objective of this study was to investigate the current situation of vancomycin~     (VAN)-associated acute kidney injury (VA-AKI) in China and identify the risk factors for~     VA-AKI, as well as to comprehensively examine the risk related to concurrent drug use.~     Further, the investigators assessed the outcomes of patients who developed VA-AKI and the~     risk factors for these outcomes. Finally, the investigators aimed to provide suggestions for~     improving the prevention and treatment of VA-AKI in China.~   "
8429|NCT03456531|"~     this study to detect the effect of pulsed radiofrequency to the suprascapular nerve in~     treating chronic pain and to evaluate range of motion of shoulder joint after the~     intervention~   "
8430|NCT03456518|"~     The concept of acute-on-chronic liver failure (ACLF) was introduced by Jalan and Williams in~     2002 to describe the acute deterioration in liver function over 2 to 4 weeks in a patient~     with well-compensated cirrhosis associated with a precipitating event (hepatotoxic:~     superimposed hepatitis viral infection, drug-induced liver injury, hepatotoxins, or excessive~     alcohol consumption; extra hepatic: variceal bleeding or sepsis), leading to severe~     deterioration in clinical status with jaundice and hepatic encephalopathy and/or HRS.~     Following this concept, several proposals for the diagnostic criteria of ACLF have been~     suggested.~   "
8431|NCT03456505|"~     The proposed study will assess the effects of mindfulness meditation training on an eye blink~     conditioning (EBC) task in a sample of novice meditators. This methodology will allow~     investigation of whether mindfulness interrupts classical conditioning through the process of~     de-automatization. Implicit learning rates, as reflective of unconscious habit formation and~     measured by the frequency of conditioned responses during the EBC, will be a main outcome of~     interest. The proposed study will also assess the effects of mindfulness meditation training~     on an emotion regulation (ER) task, with a specific focus on reappraisal of negative images~     and savoring of positive images.~   "
8432|NCT03456492|"~     Hyponatremia was defined as a serum sodium concentration <135 mmol/L that occurred at least~     once during a patient's hospital stay from admission to discharge. Elderly patients with~     fragility fractures are particularly susceptible to hyponatremia because of their impaired~     physiology, multiple comorbidities (such as hypocortisolism, hypothyroidism, hepatic~     cirrhosis, renal disease, and congestive heart failure), polypharmacy (e.g.,~     antihypertensives, antidepressants, and antiepileptics), hospitalization, perioperative fluid~     restrictions, and homeostatic stress from the fracture itself and the subsequent surgery. The~     aim of this study is to compare incidence of hyponatremia in elderly patients (>70 years)~     with hip fractures (case group) to incidence of hyponatremia in elderly patients(>70 years)~     undergoing joint replacement or prostate surgery(control group).~   "
8433|NCT03456479|"~     The study will assess the diagnosis of Cow's milk protein allergy (CMPA) among infant and~     children in Assiut University Children Hospital using skin prick test and specific serum IgE~   "
8434|NCT03456466|"~     Primary Outcome Measures:~      Area under the curve (AUC) forTQB2303 and rituximab concentrations [ Time Frame: 85 days ]~      Secondary Outcome Measures:~      The Maximum Concentration (Cmax) of the TQB2303 and rituximab [ Time Frame: 85 days ] The~     area under the plasma concentration-time curve from 0 to inf (infinite) time (AUC0-∞); The~     time to reach the maximum plasma concentration after treatment (Tmax) Total clearance (CL);~     Elimination of half-life (t1 / 2); Apparent distribution volume (Vd).~   "
8435|NCT03456453|"~     The overall aim of this R34 application is to adapt and feasibility test an evidence-based~     HIV prevention education for high-risk, underserved rural women in Appalachia. This study has~     potential to make a significant contribution to science by advancing knowledge on the use of~     social media to increase access to prevention interventions to reduce high-risk substance use~     and related health disparities among rural women during a time of emerging and significant~     public health risk in Appalachia. Successfully accomplishing study aims will respond to a~     critical and unmet need to increase access to prevention interventions using social media, as~     well as advance knowledge about the high-risk drug use behaviors among vulnerable~     populations.~   "
8436|NCT03456440|"~     Hepatitis is known to induce severe liver diseases. The evaluation of the severity of liver~     cirrhosis is very important for the selection of appropriate treatment plan and the~     monitoring of patient response to treatment, accurate staging of liver fibrosis is critical~     because it determines the indication of antiviral treatment and prognosis of patients with~     chronic viral hepatitis, DWI is a particularly appealing method for the diagnosis of liver~     fibrosis because it is easy to implement and process, without the need for contrast agents.~     Apparent diffusion coefficient (ADC) has been shown to be a promising marker of fibrosis and~     cirrhosis.~   "
8437|NCT03456427|"~     Patient-assisted compression (PAC) allows the patient to participate in controlling the~     amount of compression force during mammography and is a personalized approach that has~     demonstrated successful reduction in discomfort experienced during mammography. GE~     Healthcare's Senographe Pristina, an innovative mammography platform that provides both~     two-dimensional (2D) and three-dimensional (3D) imaging capabilities, offers both standard~     and patient-assisted compression modes. This study will evaluate image quality and clinical~     workflow as it relates to use of PAC with the Senographe Pristina 3D.~   "
8438|NCT03456414|"~     The main objective of this investigation is to assess if an intradialysis virtual reality~     exercise-based program results in an improvement in physical function and if it results in~     high adherence rates to exercise. The secondary aim is to assess the effect of intradialysis~     VR in physical activity level, health related quality of life and in cognitive function.~   "
8439|NCT03456401|"~     The study aims to evaluate the efficacy of a third TKI after two previous lines of therapy~     with TKIs, in terms of median progression free survival (mPFS), in patients affected by~     metastatic renal cancer cell.~      Patients receiving the sequence Sunitinib- Axitinib, will receive Sorafenib.~      Patients receiving the sequence Pazopanib-Sorafenib, will receive Sunitinib.~      Sorafenib dosage 400mg orally, twice a day.~      Sunitinib dosage 50 mg 4 weeks on followed by 2 weeks a rest.~      The therapy will be continued until disease progression or unacceptable toxicity.~   "
8440|NCT03456388|"~     This study evaluates the safety, tolerability and pharmacokinetics of Ammoxetine~     Hydrochloride Enteric-coated Tablets in Chinese heathy subjects. Part of the participants~     will receive Ammoxetine Hydrochloride Enteric-coated Tablets, while the other part will~     receive placebo.~   "
8442|NCT03456362|"~     The cerebellum is known to be strongly implicated in the functional reorganization of motor~     networks in stroke patients, especially for gait an balance functions. Repetitive~     transcranial magnetic stimulation of the cerebellum can be used to enhance these adaptive~     processes in stroke recovery. In this randomized, double blind, sham-controlled trial we aim~     to investigate the efficacy and safety of cerebellar intermittent theta burst stimulation~     coupled with intensive physical therapy in promoting gait recovery in hemiparetic patients~     due to recent stroke in the territory of the contralateral middle cerebral artery~   "
8443|NCT03456349|"~     Multi-centre study of HTL0018318 in patients with Alzheimer's disease as an add-on to~     standard-of-care~   "
8444|NCT03456336|"~     Estimate the risks and benefits of active treatment versus expectant management of a~     symptomatic patent ductus arteriosus (sPDA) in premature infants.~   "
8445|NCT03456323|"~     This is a single center, pilot, randomized, single-blind, usual care controlled, pragmatic~     clinical trial of a post-ICU palliative care consultation intervention in older (age ≥50~     years) survivors of acute respiratory failure.~      Aim 1: To conduct a pilot post-ICU palliative care consultation intervention trial among~     frail older ICU survivors and their surrogates. Hypothesis:The Investigators can achieve an~     adequate enrollment rate, protocol adherence, and intervention fidelity.~      Aim 2: To estimate effect sizes and variability for changes in symptoms at hospital discharge~     and 1 month, and to estimate hospice referral rates and acute-care readmission rates at 1 and~     3 months. Hypothesis: Effect sizes and feasibility data will inform and support future~     post-ICU palliative care studies focused on improving ICU survivorship.~      Exploratory Aim. To assess the use of methylphenidate that is recommended and dosed by the~     palliative care physician for the treatment of moderate-to-severe fatigue. Hypothesis: (1)~     Not all patients with moderate-to-severe fatigue will be recommended for methylphenidate~     therapy. (2) Patients prescribed methylphenidate for treatment of moderate-to-severe fatigue~     after critical illness will adhere to methylphenidate therapy.~   "
8446|NCT03456310|"~     Pelvic floor failure is a common disorder that can seriously jeopardize a woman's quality of~     life by causing urinary and fecal incontinence, difficult defecation and pelvic pain.~     Multiple congenital and acquired risk factors are associated with pelvic floor failure,~     including altered collagen metabolism, female sex, vaginal delivery, menopause and advanced~     age. A complex variety of fascial and muscular lesions that range from stretching, insertion~     detachment, denervation atrophy and combinations of pelvic floor relaxation to pelvic organ~     prolapse may manifest in a single patient.~      The prevalence of pelvic floor dysfunction increases with age. It is approximately 9.7% in~     child bearing period (20-39 yrs), while it reaches up to 49.7% by 80 yrs and older. Thorough~     preoperative assessment of pelvic floor failure is necessary to reduce the rate of relapse,~     which is reported to be as high as 30%.~      MR imaging is a powerful tool that enables radiologists to comprehensively evaluate pelvic~     anatomic and functional abnormalities, thus helping surgeons provide appropriate treatment~     and avoid repeat operations.~      Real time 2D trans-perineal ultrasound is emerging as an exciting new technique for pelvic~     floor assessment. It has advantage of providing a global view of the entire pelvic floor,~     from the symphysis to the ano-rectum, and includes the lower aspects of the levator ani~     muscle, in addition to its lower costs and greater accessibility; also sonographic imaging is~     more useful in the clinical environment, and generally better tolerated than magnetic~     resonance imaging.~   "
8447|NCT03456297|"~     The study aims to develop a Web-based clinical pedagogy program (WCP) for nurse preceptors;~     compare the WCP with the current preceptorship course on clinical teaching competence,~     assessment techniques and self-efficacy; examine nurse preceptors' attitudes toward Web-based~     learning; and explore the preceptors' perspectives of WCP.~   "
8448|NCT03456284|"~     Orphan livers are organs that have been declined for clinical use by all centers due to their~     marginality. The current standard of care of liver preservation before transplant is cold~     storage. NMP may allow these livers to be evaluated before transplantation. NMP has already~     been used in a clinical setting with promising results.The advantage to utilizing NMP is that~     it would attenuate the incidence and clinical impact of classical preservation injury, reduce~     EAD and other complications, allow liver function assessment before implantation and thus~     improve outcomes for high risk ECD liver transplants performed at our center.~   "
8449|NCT03456271|"~     The objective of this study is to find out the biochemical markers which have independent~     predictive value of fragility fractures risk with Type 2 diabetes in Guangzhou community and~     evaluate bone strength better and increase the ability of recognizing fracture risk through~     following-up visits the bone metabolism index like esRAGE-to-pentosidine ratio of the~     petients with type 2 diabetes and osteoporosis,compared with the classical fracture risk~     assessment instrument.~   "
8450|NCT03456258|"~     The study aims to compare the efficacy and the safety of Lactoferrin versus ferrous sulphate~     for the treatment of iron deficiency anemia during pregnancy.~   "
8451|NCT03456245|"~     Study compares four portable vision measurement and eye-imaging technologies in terms of~     accuracy and time and ease of use with older adult (ages 40-100) participants in a~     developing-country setting (India). Specifically, the five portable devices will be measured~     against the baseline of the traditional eye-examination techniques, including the use of eye~     charts and phoropters.~   "
8452|NCT03456232|"~     This study evaluates the effect of high-flux hemodialysis compared to hemodiafiltration on~     small and moderate molecule substances clearance. Meanwhile, this study evaluates the effect~     of high-flux hemodialysis compared to hemodiafiltration on cardiac function. In this self~     matching study, participants will receive high-flux hemodialysis compared to~     hemodiafiltration.~   "
8453|NCT03456219|"~     This study evaluates the effect of different dietary conducts in the nocturnal period on the~     postprandial metabolism and food perceptions of night workers of the Hospital of Clinics of~     Uberlândia, Federal University of Uberlândia.~   "
8498|NCT03455634|"~     Aim: to search for reasons for seeking orthodontic treatment, compliance during orthodontic~     treatment, drop-out from orthodontic treatment and success of orthodontic treatment.~      Methods: evaluation before, during and at the end of orthodontic treatment. Clinical and~     diagnostic evaluation of complexity before and at the end of orthodontic treatment,~     evaluation of awareness of treatment need, impact on social and psychological aspects,~     functional disturbances, impact of malocclusion on quality of life, social interaction,~     ability to perform daily activities.~   "
8454|NCT03456206|"~     Chronic inflammatory diseases (CID) - including inflammatory bowel diseases (Crohn's disease~     and ulcerative colitis), rheumatic conditions (rheumatoid arthritis, axial spondyloarthritis,~     psoriatic arthritis), inflammatory skin diseases (psoriasis) and multiple sclerosis are~     diseases of the immune system that have some shared genetic and environmental predisposing~     factors, but still little is known on the effects of lifestyle as a prognostic factor on~     disease risk. This observational study will contribute to preexisting research on lifestyle~     factors by identifying diet factors associated with risk of developing CID, using prospective~     register data.~      The study will use data from all of the 57,053 participants in the Danish cohort Diet,~     Health and Cancer (DHC) together with registry data. Blood samples, anthropometric measures~     and questionnaire data on diet and lifestyle were collected at the DHC study entry. The~     National Patient Registry (NPR) will be used to obtain to identify patients with CID during~     follow-up. Follow-up information on death and immigration will be collected in March 2018~     from the Danish Civil Registration Register.~      The outcome CID is defined as at least one of the following CIDs: Crohn's disease, ulcerative~     colitis, psoriasis/psoriatic arthritis, rheumatoid arthritis/ankylosing arthritis, or~     multiple sclerosis, during the follow-up period from 1993 to March 2018.~      The primary hypothesis is that the risk of CID will be significantly higher among those with~     a low fibre/high red and processed meat intake compared to those with a high fibre/low red~     and processed meat intake. Based on previous research on a shared etiology in CIDs a second~     hypothesis is that the postulated causality between low fibre/high red and processed meat~     intake and risk of developing CID is applicable for each of the CID-diagnoses.~      The core study is an open register-based cohort study. The study does not need approval from~     the local Ethics committee or Institutional Review Board by Danish law. The study was~     approved by the Danish Data Protection Agency (2012-58-0018) Study findings will be~     disseminated through peer-reviewed journals, patient associations and presentations at~     international conferences.~   "
8455|NCT03456193|"~     This is a prospective, single center, safety and feasibility trial to evaluate the~     transplantation of the left atrium and pulmonary veins in patients with pulmonary vein~     stenosis. Consented patients will be listed for transplantation. Once a suitable donor has~     been identified, the left atrium, pulmonary veins and complete lung block will be harvested~     from the donor and transported to Boston Children's Hospital as is the procedure for routine~     lung transplantation patients. The left atrium and pulmonary veins will be transplanted into~     the recipient. The recipient will receive the normal immunosuppression protocol used for~     heart transplantation.~      This pilot study will include 5 patients.~   "
8456|NCT03456180|"~     Sepsis is defined as a life-threatening event due to a dysregulated immune response to an~     host. Blood purification techniques may be considered as a therapeutic weapon to front sepsis~     and septic shock.~      Haemoadsorption is one of the known blood purification technique that is employed in this~     study, and it is based on the principle that whole blood, contacting the surface of proper~     designed sorbent, would be cleared of certain substrates. With haemoadsorption it is possible~     to de-circulate from bloodstream high molecular weight substances, such as cytokines.In this~     study Cytosorb® cartridge, based on haemoadsorption principle is applied on septic patients,~     suffering for acute kidney failure, along with continuous veno-venous haemodialysis~     (CVVH-D).Microcirculation has a crucial role in the natural history of sepsis.~      In this prospective observational non interventional study, 10 septic patients with an acute~     kidney failure that need CVVH are enrolled.~      The primary endpoint of the study is to verify an improvement in the density of~     microcirculatory vessels and in the quality of blood flow after exposure to Cytosorb®. These~     two parameters are well described synthetically by the Perfused Vessel Density (PVD).~      As secondary endpoints we also want to analyze the modification of microcirculation after~     haemoadsorption therapy: microvascular blood flow, described by the microvascular flow index~     (MFI) and peripheral tissue oxygen perfusion during Cytosorb® exposure using near infrared~     spectroscopy technique (NIRS)~   "
8457|NCT03456167|"~     This study will assess whether the implementation of a combination of ERAS (Enhanced Recovery~     After Surgery) protocols and postoperative followup via a smartphone app can offer 1)~     improved patient satisfaction, 2) virtual patient monitoring without an increase in~     postoperative emergency room visits, number and severity of postoperative complications, and~     readmissions, 3) decreased healthcare system costs, and 4) improved patient convenience and~     reduced patient financial costs. The study will be conducted among women having mastectomy,~     breast reconstruction, and gynecological oncology procedures. Half of the participants will~     be assigned to physician monitoring via a smartphone app and half will receive conventional~     care.~   "
8458|NCT03456154|"~     This randomized clinical trial will compare the standard treatment (occlusal splint) and~     botox for the treatment of face muscular pain in adults. Fifty patients will be invited and~     selected, and allocated to the experimental group, according to the randomization sequence~     previously performed. For the splint group, a rigid splint will be worn by the patient every~     night. For the botox group, 60u of botox will be injected in 3 regions of the masseter~     muscle. Patients will be assessed before the experiment, 3 and 6 months after the beginning~     of the study. Oral health related quality of life, pain, and cervical neck position will be~     evaluated. Paired t-test and chi-square will be used for statistical analysis.~   "
8459|NCT03456141|"~     With a prospective, observational study assess post-surgery pain levels and patient's use of~     opioids and other analgesic drugs to moderate pain following third molar surgery.~   "
8460|NCT03456128|"~     This study evaluates whether the utilization of integrated health services such as help with~     medications, muscle strengthening, balance training, pain management and home modification~     interventions can help improve older adults' ability to sleep, balance, walk, and take care~     of themselves after hospitalization.~   "
8461|NCT03456115|"~     The research team has developed a prototype for an investigational mechanical nasal dilator~     and the investigators aim to evaluate its efficacy.~      Specifically, the investigators wish to address the following research questions: 1) How does~     mechanical nasal obstruction affect patients' lives? The investigators aim to answer this~     question with use of validated questionnaires. 2) How do currently available mechanical nasal~     dilators affect objective and subjective findings related to nasal obstruction? This will be~     evaluated with objective nasal airflow testing and with modifications to validated~     questionnaires 3) How does the investigational team's novel device affect these same outcome~     measures? 4) Do patients find the investigational device subjectively comfortable and~     efficient?~   "
8499|NCT03455621|"~     The aim of the study is to determine the fluoride availability in saliva and dental biofilm~     after the use of increasing amounts of fluoride toothpaste. Using a crossover and blind~     design, 15 children (18-42 months old) had their teeth brushed with increasing amounts of~     fluoride toothpaste. Fluoride concentration in saliva and dental biofilm was determined up to~     30 min after brushing.~   "
8578|NCT03454581|"~     The aim of the present study was to investigate the effect of photobiomodulation (PBM) and~     manual therapy (MT) isolated or combined in the reduce of pain, the improve of mandibular~     movements, the psychosocial aspects and the anxiety symptoms of patients with TMD.~   "
8462|NCT03456102|"~     There is an urgent need for novel therapies to shorten TB treatment and improve long-term~     lung function outcomes. Host-directed therapies (HDT) have received significant attention~     recently given the ability of M. tuberculosis to subvert host immune responses and cause~     destructive lung pathology. Statins are among the most promising HDT agents for TB. In~     addition to having a highly favorable safety profile, statins have been shown to have anti-TB~     activity in macrophages, to synergize with anti-TB drugs, and to shorten the duration of TB~     treatment in the standard mouse model.~      The StAT-TB trial will comprise two different stages. In the 14-day Stage 1 study,~     investigators will test the safety and tolerability, as well as Pharmacokinetics (PK), of two~     different doses of pravastatin co-administered with standard anti-TB treatment. In Stage 2,~     investigators will test the ability of pravastatin adjunctive therapy (dose to be determined~     in Stage 1) to shorten the mean time to sputum culture conversion (primary endpoint) and~     improve lung function outcomes (secondary endpoints) relative to the standard regimen. In~     addition, investigators will continue to investigate the anti-TB mechanism of action of~     pravastatin in order to further improve HDT options for TB in the future.~   "
8463|NCT03456089|"~     The investigators have developed a novel pressure monitoring device that hooks to standard~     urinary catheters. The investigators will be testing how the pressure measurements recorded~     with this device compare to the gold standard measurement of urodynamics.~   "
8464|NCT03456076|"~     This randomized, active-controlled, multicenter, open-label, Phase III study is designed to~     investigate the efficacy and safety of alectinib compared with platinum-based in the adjuvant~     setting. Participants in the experimental arm will receive alectinib at 600 mg orally twice~     daily (BID) taken with food for 24 months.~      Participants in the control arm will receive one of the protocol specified platinum based~     chemotherapy regimens for 4 cycles. Following treatment completion, participants will be~     followed up for their disease until disease recurrence. At the time of disease recurrence,~     participants will enter a survival follow-up until death, withdrawal of consent or study~     closure, whichever occurs earlier.~   "
8465|NCT03456063|"~     This is a randomized, double-blinded study designed to evaluate the efficacy and safety of~     neoadjuvant treatment with atezolizumab (MPDL3280A) or placebo in combination with~     platinum-based chemotherapy in patients with resectable Stage II, IIIA, or select IIIB~     non−small cell lung cancer (NSCLC) followed by open-label adjuvant atezolizumab or best~     supportive care and monitoring.~   "
8466|NCT03456050|"~     The aims of this study are to examine the effectiveness of functional range conditioning in~     patients with chronic non-specific low back pain in terms of improving hip internal rotation~     and strength of the hip abductors, and reducing pain and disability.~   "
8467|NCT03456037|"~     The aim is to investigate incidence of HBsAg, anti-HCV in serum samples and evaluation of~     biomarkers taken from patients who were followed the intensive care unit of Sakarya~     University Training and Research Hospital and The intensive care unit attracts attention by~     making health workers more susceptible to the risk of hepatitis.~   "
8468|NCT03456024|"~     Exploration of abdominal pain post sleeve gastrectomy in morbid obese patients~   "
8469|NCT03456011|"~     The study evaluates pain relief and subsequent range of motion changes combining battlefield~     acupuncture with sodium hyaluronate vs local anesthetic and sodium hyaluronate~   "
8470|NCT03455998|"~     The study aims to explore patients perception of chronic abdominal pain after Roux en Y~     gastric bypass surgery for morbid obesity. The investigators aim to describe characteristics~     of symptoms of pain. Potential risk factors for developing abdominal pain post gastric bypass~     will be explored.~   "
8471|NCT03455985|"~     Diabetes is present in 25% of hospitalized patients; yet effective hospital discharge~     programs for patients with diabetes are understudied. In particular, patients who are~     initiating or intensifying insulin therapy have the most to benefit in terms of glycemic~     control. However, these patients are also particularly vulnerable to poor transitions of care~     for a variety of reasons, including the complexity of therapy, inadequate patient education,~     differences in patient and provider expectations, and insufficient resources. Disruption of~     insulin therapy following hospitalization is associated with higher HbA1c, shorter survival,~     and increased readmissions and medical costs. In a Society of Hospital Medicine Survey, only~     one fourth of hospitals were supported with written protocols to standardize medication,~     education, equipment, and follow-up instructions. However, discharge order sets have largely~     been limited to the inpatient setting and have not been utilized to guide insulin use at~     hospital discharge. This study will assess whether a nurse supported diabetes focused~     inpatient discharge order set (DOS) can improve post-discharge outcomes among hospitalized~     patients with poorly controlled insulin-requiring diabetes.~   "
8472|NCT03455972|"~     Placing a tumor antigen chimeric receptor that has been created in the laboratory into~     patient autologous or donor-derived T cells may make the body build immune response to kill~     cancer cells. Genetically engineered lymphocyte (CART) therapy has showed good safety and~     efficacy in treatment of lymphoma and acute lymphoblastic leukemia. Researchers want to see~     if this helps people with high risk multiple myeloma after auto-HSCT. To test the safety and~     efficacy of giving targeting CD19 or B-cell maturation antigen T cells in treating patients~     with CD19 or BCMA positive high risk multiple myeloma followed with auto-HSCT.~   "
8473|NCT03455959|"~     Determining how memory T helper type 2 (Th2) initiate recall responses to aeroallergens has~     the potential to change the therapeutic approach to allergic asthma, the most common asthma~     subtype. ~5-10% of effector Th2 cells recruited into the lung give rise to long-lived tissue~     resident memory cells that are poised to respond upon allergen re-exposure.Consequently,~     targeting memory Th2 cell activation is an attractive therapeutic strategy. However, it is~     not well understood how allergen inhalation initiates a memory Th2 cell response in the lung.~     The focus of this new study on the role of lung-resident memory Th2 cells in orchestrating~     the recall response to allergen in the lung, including the recruitment and activation of~     circulating Th2 cells, is a natural, timely and exciting extension of the investigators'~     ongoing Allergen Challenge Protocol.~   "
8512|NCT03455452|"~     This is a French, nationwide, prospective, observational, multicenter study in participants~     diagnosed with renal call carcinoma, who start a new systemic therapy with nivolumab for the~     first time and within the market authorization approval, following a first or second-line~     therapy.~   "
8474|NCT03455946|"~     The DASH diet is a proven behavioral strategy to reduce blood pressure, however, national~     adherence rates are poor. Using digital health tools may help to improve adoption of the DASH~     diet. Digital health approaches capitalize on the ubiquitous utilization of mobile~     technologies and have broad dissemination potential. There have been few efforts to test a~     DASH intervention via digital, and none using voice-activated technologies (e.g, Amazon~     Alexa). This proposal will enroll up to 20 participants to leverage a commercial diet~     tracking application, an existing intervention technology platform and the Amazon Echo Dot to~     test the feasibility of using DASH Cloud, a digital health intervention, with the Amazon~     Alexa personal assistant.~   "
8475|NCT03455933|"~     The aim of this study is to evaluate whether the intensity of pain perceived during the~     application of extracorporeal shockwave therapy (ESWT) is determinant for producing changes~     in pressure pain threshold (PPT) in asymptomatic subjects. The investigators will perform a~     single controlled random trial to three groups. Two of them will receive ESWT whereas the~     third group will get a cold pressure test (CPT).~   "
8476|NCT03455920|"~     Sleep apnea is a prevalent problem and references for the evaluation of this condition often~     exceeds the sleep clinic's capacity thus creating important delays in the patients' care.~      The overall goal of this project is to assess the feasibility and the non-inferiority of~     integrating a clinical nurse, or supernurse, to the initial consultation team.~      The hypothesis is that the integration of a clinical nurse to the sleep clinic's evaluation~     team is non inferior in terms of patients' outcomes such as improvement of symptoms and~     quality of life as well as adherence to treatment.~      This study is supported by funding dedicated to teaching and research activities related to~     sleep-disordered breathing.~   "
8477|NCT03455907|"~     Self-administered questionnaire survey to determine the presence or absence of joint pain~     during bevacizumab treatment for lung, ovarian, colorectal cancers.~      The principal end-point is the frequency of arthralgia after 6 months of treatment with~     Bevacizumab.~   "
8478|NCT03455894|"~     DETECT'CHUTE CLINIBED is a smart carpet equipped with several sensors. Positioned at the foot~     of the bed, this system allows detecting i) patient fall out of the bed and ii) when patient~     is not back to bed after a certain time. When one of these two events is detected, the system~     then sends a short message syteme (SMS) and/or an email to the medical staff. The aim of this~     clinical study is to test the system ability to detect and transmit alarms for both those~     events.~      In this clinical trial, the investigators will therefore test the alarms positive and~     negative predictive values for both the events.~   "
8479|NCT03455881|"~     The investigators propose a preliminary study performing exome sequencing on samples from~     patients and their biologically related family members with tracheal and esophageal birth~     defects (TED). The investigators will use advanced, non-invasive magnetic resonance imaging~     (MRI) techniques to assess tracheal esophageal, lung, and cardiac morphology and function in~     Neonatal Intensive Care Unit (NICU) patients. The purpose of this study is to determine if~     patients diagnosed with TED and similar disorders carry distinct mutations that lead to~     predisposition and to determine if an MRI is a more effective way of evaluating the TEDs.~   "
8480|NCT03455868|"~     Background: Bone fragility is a complication of type 2 diabetes. Diabetes treatments may~     ameliorate or deteriorate bone fragility in this population. Bariatric surgery is gaining in~     popularity in people with type 2 diabetes and may impact bone health. Objectives: To~     determine, in people with type 2 diabetes and obesity undergoing bariatric surgery: (1) the~     impact of 3 bariatric procedures namely sleeve gastrectomy, Roux-in-Y gastric bypass and~     biliopancreatic diversion, on bone fragility; (2) what factors influence bone fragility after~     bariatric surgery.~      Research project overview: This study will involve 3 research centres in the province of~     Quebec. It will include 105 patients with type 2 diabetes who are undergoing bariatric~     surgery (35 patients per type of bariatric procedure) and 20 individuals without type 2~     diabetes and obesity who will serve as controls. Bone density and factors that may influence~     bone density (including improved diabetes control and changes in abdominal fat, muscle mass,~     physical activity, nutrition, hormones, etc.) will be evaluated before surgery and at 1 and 2~     years after surgery.~      Relevance to diabetes: This study is important for both the patient with type 2 diabetes~     undergoing bariatric surgery and healthcare professionals to inform on the benefits and risks~     of each bariatric procedure. It will also help identify factors that could be tested to~     prevent or treat bone fragility in people with type 2 diabetes.~   "
8481|NCT03455855|"~     This clinical study is a prospective, non-randomized, multicenter, single-arm study to~     demonstrate the acceptable safety and performance of the JETSTREAM™ Atherectomy System~     (Jetstream) used during percutaneous peripheral vascular intervention in patients with~     occlusive atherosclerotic lesions in the native SFA and/or PPA. It is intended that all~     patients with qualifying lesions would be considered for enrollment and treated with the~     Jetstream System.~   "
8482|NCT03455842|"~     The study is Phase II randomized, double-blind, placebo-controlled clinical trial to evaluate~     efficacy and safety, pharmacokinetics and pharmacodynamics of 2 dosing regimens (qw and q2w,~     s/c) of monoclonal antibody to IL6R (BCD-089) in patients with active rheumatoid arthritis~     and inadequate response to methotrexate.~   "
8483|NCT03455829|"~     This is a study to investigate the potential clinical benefit of G1T38 as an oral therapy in~     combination with osimertinib in patients with EGFR mutation-positive metastatic non-small~     cell lung cancer.~      The study is an open-label design, consists of 2 parts: safety, pharmacokinetic, and~     dose-finding portion (Part 1), and randomized portion (Part 2). Both parts include 3 study~     phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase~     begins on the day of first dose with study treatment and completes at the Post-Treatment~     Visit. Approximately, 144 patients will be enrolled in the study.~   "
8484|NCT03455816|"~     Based on international recommendations, the current clinical research project considers the~     effectiveness of a free diabetes app with a CE (Conformité Européenne) mark, Social~     Diabetes, which incorporates the addition of a glucometer (Glucomen Areo) it allows using~     NFC technology the automatic introduction of data, evaluating the impact on metabolic results~     and other related psychosocial variables, in people with diabetes 1 through a randomized~     randomized study during 6 months of follow-up.~   "
14357|NCT03378986|"~     This is an observational prospective study aimed to assess the lower limbs motor and~     functional recovery in patients who underwent to unilateral THA respect to simultaneous~     bilateral THA, in early postoperative phase.~   "
8486|NCT03455790|"~     The aim of the study is to investigate the relationship between shoulder internal and~     external rotation isokinetic muscle strength, grip strength, anaerobic capacity, aerobic~     capacity and sportive performance in wheelchair basketball athletes. Through this work, we~     aim to contribute to the literature with objective, blood-based results.~      The wheelchair (WC) basketball characterizes high intensity activities such as rolling,~     rebounding, rolling, smashing overhead. Because these activities are fast and powerful, they~     require both anaerobic and aerobic capacities. The main factors affecting WC Basketball~     performance are upper extremity muscle strength and aerobic capacity. It is stated that~     higher muscle power and aerobic performance in WC Basketball will provide more independence~     in daily life activities as well as increased speed and power during sports play.~      WC basketball players have both a spore-specific activities and a shoulder rotational muscle~     strength aerobic power components have a critical functional role when using a wheelchair.~     When the literature on this subject is examined, it is seen that there is a limited number of~     works for WC basketball sport which is very popular nowadays. Assessment of upper limb muscle~     strength, aerobic capacity and sporting performance in wheelchair basketball athletes is~     crucial in regulating the athletes' training programs and establishing individual training~     programs.~   "
8487|NCT03455777|"~     This is a single center, open-label study to evaluate the efficacy of AKCEA-ANGPTL3- LRX for~     reduction of low density lipoprotein cholesterol (LDL-C) levels in patients with Homozygous~     Familial Hypercholesterolemia (HoFH).~   "
8488|NCT03455764|"~     This research study is studying a combination of targeted therapies as a possible treatment~     for advanced melanoma that was found to have a BRAF V600E or BRAF V600K genetic mutation.~      The interventions involved in this study are:~        -  MCS110~        -  Dabrafenib~        -  Trametinib~   "
8489|NCT03455751|"~     The primary objectives of this study are to evaluate the potential for preoperative~     pharmacogenomics (PGx) testing to positively influence postoperative opioid use through~     visual analog scale (VAS) guided administration of narcotic equivalent and lower pain scores~     as measured by OBAS in patients undergoing major abdominal surgery.~   "
8490|NCT03455738|"~     Dynamic arterial elastance (Eadyn) has been proposed as an indicator of arterial tone that~     can predict norepinephrine-dependent arterial pressure. Eadyn is calculated using the ratio~     of respiratory pulse pressure variation (PPV) over the respiratory stroke volume variation~     (SVV). Guinot et al demonstrated a decrease in the duration of norepinephrine treatment with~     the use of Eadyn. To date, studies that have validated Eadyn at bedside have used cardiac~     output (CO) calibrated pulse contour analysis (PiCCO™, Pulsion™) or oesophageal doppler. Such~     monitoring systems need dedicated and specific arterial line and venous access that may limit~     their use at bedside. In addition to CO calibrated pulse contour analysis, CO uncalibrated~     pulse contour analysis has been developed and is considered less invasive. Nevertheless, one~     limitation of the latter CO monitoring is inaccuracy of CO measurement in patients who are~     being treated with norepinephrine. These limitations may affect the predictability of Eadyn.~     We conducted a prospective study in a university hospital ICU. Patients with vasoplegic~     syndrome for whom the intensive care physician planned to decrease the norepinephrine dosage~     were included. Hemodynamic and uncalibrated pulse contour analysis (Volume view, FloTrac,~     Edwards Lifescience, Irvine) values were obtained before and after decreasing the~     norepinephrine dosage. Responders were defined by a >10% decrease in mean arterial pressure~     (MAP).~   "
8491|NCT03455725|"~     Prospective, multi-center, 2:1 randomized (Treatment : Sham Control), sham-controlled,~     double-blinded trial to compare treatment using the CardiAMP cell therapy system to sham~     treatment~      Treatment Group:~      Subjects treated with aBMC using the CardiAMP cell therapy system~      Sham Control Group:~      Subjects treated with a Sham Treatment (no introduction of the Helix transendocardial~     delivery catheter, no administration of aBMC)~   "
8492|NCT03455712|"~     Women with singleton pregnancies at one outpatient clinic to be recruited for controlled~     clinical trial. Over eight weeks, women 15 0/7--22 6/7 weeks' with at least one prior~     prenatal visit to be enrolled in the control group. Women 6 0/7--14 6/7 weeks' to be enrolled~     in the intervention group at their first prenatal visit and to receive a pregnancy-specific~     gestational weight gain card. Women to be encouraged to record their weight at each prenatal~     care visit. All women to complete a GWG knowledge--based questionnaire at 15 0/7‐22 6/7~     weeks'.~   "
8493|NCT03455699|"~     The VeClose Five Year Follow-up Extension Study will seek to gain additional follow-up data~     from the patients enrolled in the VeClose study (NCT01807585).~   "
8494|NCT03455686|"~     This is a single centre exploratory study that aims to apply hyperpolarized xenon-129 (129Xe)~     magnetic resonance imaging (MRI) methods and measurements in individual patients with and~     without lung disease to better understand lung structure and function and evaluate response~     to therapy delivered as a part of clinical care.~   "
8495|NCT03455673|"~     Atrial fibrillation is the most frequent heart rhythm disorder. Its symptomatic forms,~     resistant to drug therapy, require invasive management (catheter ablation), which exposes to~     potentially serious complications including thromboembolic complications. Despite~     anticoagulant treatment, intra-atrial thrombus, which is a contraindication to catheter~     ablation, is detected in nearly 2 % of cases. Its diagnosis requires prior transoesophageal~     echocardiography, an unpleasant examination.~      A previous study (NCT02199080) showed that a zero ATE score, defined by no heart failure, no~     hypertension, no history of stroke, d-dimer < 270 ng/mL, has a negative predictive value of~     100 % for the exclusion of intra-atrial thrombus.~      The objective of the study is to confirm the negative predictive value, sensitivity and~     specificity of the ATE score for the exclusion of intra-atrial thrombus.~   "
8496|NCT03455660|"~     The objective is to retrospectively gather peri-operative data on neonatal outcomes,~     primarily neonatal acid-base status, based on umbilical cord gas analysis, for the 23 months~     preceding and 23 months following the conduct of the tilt versus supine study. The~     investigators hypothesize that there will be no difference in mean neonatal umbilical artery~     base excess in neonates delivered by cesarean section during the period before and after~     conduct of the study, for elective, urgent and emergent deliveries.~   "
8497|NCT03455647|"~     This study is a mixed-methods cluster-randomized controlled trial in Rwanda designed to~     measure the impact of a dairy asset transfer program with or without nutrition education~     promoting the home consumption of dairy milk and other animal source foods.~   "
8500|NCT03455608|"~     Dysphagia (difficulty swallowing) is a common and potentially life-threatening toxicity of~     radiotherapy (RT) for patients with head and neck cancer (HNC). HNC survivors have a 20-24~     percent lifetime risk of pneumonia after RT, which is associated with a 42 percent excess~     risk of death in survivorship. Moreover, dysphagia predisposes individuals to malnutrition,~     and at least half of HNC patients require feeding tubes during RT.~      Patients are commonly referred for swallowing therapy with a speech pathologist. Some~     patients receive early intervention, before a swallowing problem begins—PRO-ACTIVE therapy.~     Other patients are monitored and prescribed dysphagia interventions only if and when a~     swallowing problem occurs—RE-ACTIVE therapy. Thus, REACTIVE therapy aims to reverse an~     already impaired swallowing ability, whereas PRO-ACTIVE therapy aims to prevent or reduce~     severity of dysphagia. These two broad categories of therapy represent the most common types~     of intervention offered to HNC patients across North America. Although there is~     single-institution evidence to support each practice, it is yet unknown which is most~     effective.~      To address this gap, the primary aim of this international, multi-site 3-arm pragmatic~     randomized clinical trial is to compare the effectiveness of PRO-ACTIVE (high and low~     intensity) versus RE-ACTIVE swallowing therapy among 952 patients with HNC planning to~     undergo RT, using duration of feeding tube dependence after RT as the primary outcome. Our~     secondary aim proposes to compare the relative benefit or harm of these swallowing~     interventions on secondary outcomes considered relevant to our stakeholder partners.~   "
8501|NCT03455595|"~     Prospective study so as to evaluate CONECCT score to determine both histological tissue and~     therapeutic choice~   "
8502|NCT03455582|"~     Cognitive impairment is nowadays more and more recognized as an important feature of the~     multiple sclerosis (MS) disease. Cognitive disorders frequency in MS is estimated between 40~     and 60%. Cognitive impairment affects quality of life and vocational status in MS patients.~      Until recently, little information was available on the cognitive dysfunction and their~     evolution that occur in primary progressive multiple sclerosis (PPMS) as compared with~     relapsing-remitting MS (RRMS). In PPMS pathological studies have shown the importance of~     cortical demyelination and meningeal inflammation suggesting that the GM alteration could~     play a major role in the cognitive impairment in this phenotype. The cognitive evolution and~     the brain tissue alteration at the origin of these difficulties remain poorly understood in~     PPMS. The use of new techniques for morphological and functional MRI can study the~     contribution of diffuse White Matter (WM) alteration (probably through disconnexion of~     relevant network) and diffuse Grey matter (GM) alterations in the cerebral cortex and other~     structures (the hippocampi, the cerebellum, and the thalami) in cognitive impairment in PPMS~     patients and on their evolution.~   "
8503|NCT03455569|"~     Studies consistently show the negative health impact of sleep problems in both Alzheimer's~     disease (AD) patients and their caregivers. However, only a few sleep interventions have been~     conducted for AD patients or their caregivers in community settings and none have addressed~     both members of the dyad concurrently. To fill these gaps, this study aims to develop a sleep~     intervention program specifically tailored for AD patient/caregiver dyads who both experience~     sleep difficulties.~   "
8504|NCT03455556|"~     This phase I/II trial studies the best dose and side effects of anetumab ravtansine when~     given together with atezolizumab and how well they work in treating participants with~     non-small cell lung cancer that has spread to other places in the body. Monoclonal~     antibodies, such as anetumab ravtansine and atezolizumab, may interfere with the ability of~     tumor cells to grow and spread.~   "
8505|NCT03455543|"~     Part A of this trial is a multi-center, prospective, double-blinded, sham-controlled,~     randomized clinical trial. Part A will evaluate PEMF treatment compared to sham treatment in~     patients with painful diabetic distal symmetric peripheral neuropathy (DSPN) when treatment~     is administered 30 minutes twice daily through a 120-day period (4 months). Part B is a~     2-month open-label active treatment extension period designed to collect longer-term data on~     pain, medication use, quality of life and safety (Part B).Part B of this trial is a an~     extension period upon completion of Part A.~   "
8506|NCT03455530|"~     This project aims to reduce negative health outcomes in small businesses that primarily~     employ high-risk Latino workers by characterizing their exposures to hazardous chemicals and~     assessing if a community health worker (CHW) intervention is effective at decreasing these~     exposures. Although preventable by definition, occupational disease and injuries are leading~     causes of death in the United States, with a disproportionate burden faced by Latinos. Small~     businesses pose a particular risk. They are more likely to employ low-wage Latino workers,~     and often use hazardous solvents including volatile organic chemicals that can cause asthma,~     cancer, cardiovascular, and neurological disease; yet their workers lack access to culturally~     and linguistically appropriate occupational health and pollution prevention information due~     to economic, physical, and social barriers. CHW-led interventions and outreach in Latino~     communities have documented increased access to health care and health education and reduced~     workplace exposures among farmworkers. CHWs are an innovative method to bridge the gap~     between these small business communities and other stakeholders. The proposed project will~     capitalize on established partnerships between the University of Arizona, the Sonora~     Environmental Research Institute, Inc. and the El Rio Community Health Center. A~     community-engaged research framework will be used to complete the following specific aims: 1)~     quantify and identify exposures to hazardous chemicals in the two high risk small business~     sectors common in our target area (i.e., auto repair shops and beauty salons); 2) work~     collaboratively with business owners, trade groups, workers and CHWs to design an industrial~     hygiene - enhanced CHW intervention tailored for each small business sector; and 3) conduct a~     cluster randomized trial to evaluate the effectiveness of the CHW intervention at reducing~     workplace exposures to volatile organic compounds and assess which factors led to successful~     utilization of exposure control strategies in both male and female-dominated businesses.~     Businesses will be randomized to either an intervention or delayed intervention group, both~     of which will receive incentives to participate including worksite health screenings. CHWs~     will work closely with business owners and employees to select and implement~     exposure-strategies appropriate for their worksite using a menu of complementary strategies~     of varying complexity and cost. This innovative project has the potential to directly reduce~     occupational health disparities through a CHW intervention that moves beyond providing~     occupational health education. The intervention will overcome current barriers by helping~     marginalized Latino workers and small business owners who may have limited education,~     literacy, and computer skills to understand the hazards associated with their work, and will~     empower them to have greater control over their occupational exposures, with the ultimate~     goal of preventing occupational disease and reducing health disparities.~   "
8507|NCT03455517|"~     Fludarabine, cyclophosphamide, and rituximab (FCR) is the gold treatment for fit and young~     patients with Chronic Lymphoid Leukemia (CLL). However, patients with a mutation known as~     IGVH unmutated and patients with a particular characteristic known as 'disrupted TP53' show~     an inferior outcome after FCR in terms of survival. Venetoclax as a single agent or combined~     with rituximab is an effective treatment for relapsed/refractory patients with IGVH unmutated~     CLL and/or del(17p) and is associated with a high rate of clinical responses.~   "
8508|NCT03455504|"~     This study will test the effectiveness and safety of Venetoclax in combination with standard~     induction regimen for patients with acute leukemia and poor prognosis.~   "
8509|NCT03455491|"~     A multicenter double-blinded, randomized, placebo-controlled, parallel-group comparative~     Phase II clinical study to assess safety, tolerability, efficacy and optimal dose of XC221~     vs. placebo in patients with uncomplicated influenza or other ARVI during a 3-day treatment.~      The primary objective of the study is to demonstrate the difference in time before the onset~     of a sustained improvement in clinical symptoms according to the Modified Jackson Scale for~     ARVI and to determine the optimal dose of XC221 in the treatment of influenza and other ARVI.~   "
8510|NCT03455478|"~     Blindness and visual impairment severely impact the visual health and life quality of people,~     particularly the 2.566 million senior citizens aged at 65 and above in Shanghai. The main~     reason is uncorrected refractive error, of which, 62.1% can be solved through refractive~     correction. For this reason, the uncorrected refractive errors of 154,000 senior citizens in~     Shanghai can be taken as a priority among the public health issues to prevent blindness. Now,~     with the aim to reduce the prevalence rate of blindness and visual impairment, it is planned~     to establish a public health service mechanism in terms of refractive error screening and~     correction for the elderly by relying on Shanghai's three-level (city-district-community) eye~     diseases prevention network, using proper refractive correction technology, and moving~     related services forward to communities in order to screen, identity, and correct blindness~     and visual impairment caused by refractive errors as early as possible.~   "
8511|NCT03455465|"~     This study is evaluating the effectiveness of the post-discharge program facilitated by the~     Community Health Worker program in the Emergency Department at NYU Langone Health Hospital -~     Brooklyn and testing different strategies to increase patient engagement in the program.~   "
8514|NCT03455426|"~     Rationale: Intrauterine insemination (IUI) is the treatment of first choice for couples with~     unexplained and mild male factor infertility in many countries, but it is controversial~     whether ovarian stimulation improves fertility outcomes. In recent retrospectively collected~     data, investigators found that in couples with unexplained and mild male factor infertility~     undergoing IUI, ovarian stimulation with letrozole increased live birth rate as compared to~     natural cycle IUI without substantially increasing the multiple pregnancy rate. Investigators~     therefore perform a randomized clinical trial (RCT) on the subject in the Centre of~     Reproductive Medicine, Peking University Third Hospital, Beijing, China.~      Objective: To test the hypothesis that in couples with unexplained or mild male factor~     infertility scheduled for an IUI program ovarian stimulation with letrozole increases the~     live birth rate as compared to natural cycle treatment.~      Study design Randomized clinical trial.~      Study population Women diagnosed with unexplained or mild male factor infertility scheduled~     for treatment with IUI.~      Intervention Women will be randomized for ovarian stimulation with letrozole or to natural~     cycle IUI. In the group allocated to ovarian stimulation, women will receive oral tablets~     letrozole 5 mg daily from cycle day 3-5 for 5 days. Investigators will treat the couples for~     3 cycles, with a time horizon of 4 months.~      Main study parameters/endpoints Primary outcome is ongoing pregnancy leading to live birth.~     Secondary endpoints are clinical pregnancy, multiple pregnancy, miscarriage rates, pregnancy~     complications and patients' costs.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness The strategies compared are already broadly applied in current practice. No~     additional risks are expected. There is no benefit for participants, but the results may~     benefit future subfertile couples.~   "
8515|NCT03455413|"~     This is purely observational study in which quality of invasive ventilation is observed with~     electrical impedance tomography (EIT) during perioperative intensive care. EIT parameters~     will be used to assess if protective ventilation strategies are successfully followed during~     routine care.~   "
8516|NCT03455400|"~     Electrical impedance tomography (EIT) is an evolving monitoring tool for respiratory support~     in neonatal and pediatric intensive care. In this observational study basic EIT parameters~     will be measured on 20 healthy newborn infants during spontaneous breathing and assess the~     effect of position changes in ventilation distribution.~   "
8517|NCT03455387|"~     The pre-eclampsia is a frequent pathology, concerning approximately 5 % of the~     pregnancies.The pre-eclampsia can evolve into severe maternal and\or foetal complications and~     is a major cause of mortality.~      The purpose of the study will to estimate the relevance of the serum markers sFlt1 and PlGF~     to predict the arisen of severe complications at these patients, what would allow to decrease~     the materno-fœtale morbi-mortality due to the pathology.~   "
8518|NCT03455374|"~     This is a prospective, nonrandomized, single-arm study using CSI Orbital Atherectomy System~     in patients with PAD (total occlusions or significant stenosis). Patients will be enrolled if~     they have claudication and/or critical limb ischemia, and identifiable PAD disease with~     moderate to severe calcification on Computer Tomography Angiogram (PCA) or peripheral~     angiogram requiring percutaneous peripheral intervention (PPI).~   "
8519|NCT03455361|"~     Clinical evaluation of osteointegration of bone level implants (Stark conical screw implants,~     with V-Blast surface treatment), placed without sufficient primary stability.~   "
8520|NCT03455348|"~     Dysfunctions radial arterial catheter are frequent. This was a prospective, randomized~     observational study monocentric in ICU in France. Patients are randomized in 2 groups : One~     to less than 4 four centimeters to the wrist joint (Group A) and the other, to more than four~     centimeters to the wrist joint. (Group B). The primary outcome was the incidence of catheter~     dysfunction (defined by the impossibility of taking blood from the catheter and / or the~     impossibility having a reliable blood pressure curve). Investigators compared also the~     incidence of infection, satisfaction of doctors and nurses, the numbers of days with catheter~     and the cause of withdrawal.~   "
8521|NCT03455335|"~     The trial is a phase 1b, open label, uncontrolled, non-randomized dose-escalation study of~     autologous bone marrow-derived MSCs. Following informed consent, patients who meet the~     criteria will be screened and enrolled. Up to 100 mls of bone marrow will be harvested from~     the participant from which MSCs will be culture expanded. In this dose escalation study, 3~     participants on each cohort will be treated with a targeted dose of either 20 million hMSC;~     40 million hMSC; or 80 million hMSC. The cells will be administered to the ischemic leg by 20~     intramuscular injections of approximately 0.5ml per injection . Treatment groups will be~     completed sequentially, beginning with the lowest dose group.~   "
8522|NCT03455322|"~     compare the efficacy of each drug; norepinephrine versus midodrine &octreotide on renal~     function & survival in patients with HRS.~   "
8523|NCT03455309|"~     The proposed study aims to further evaluate the safety and immunogenicity of a candidate S.~     aureus vaccine NDV-3A, as well as its efficacy against acquisition of S. aureus~   "
8524|NCT03455296|"~     the study aimed to compare the efficacy of lactate clearance versus ScVO2 to guide fluid~     management post-operative in intensive care unit (ICU).~   "
8525|NCT03455283|"~     The purpose of this study is to prospectively collect data on the pattern of use for~     gadolinium-based contrast agents (GBCAs) in real-life setting with special reference to~     Clariscan after its commercial launch in Europe and in addition quality of images, diagnostic~     confidence and customer satisfaction will be assessed on a Likert scale by the local~     radiologist/technician and spontaneously reported immediate and delayed adverse events (AEs)~     to assess the effectiveness and safety profile of GBCAs in clinical practice respectively.~   "
8526|NCT03455270|"~     This is a study to investigate the potential clinical benefit of G1T48 as an oral selective~     estrogen receptor degrader (SERD) in patients with estrogen receptor-positive, HER2-negative~     metastatic breast cancer.~      The study is an open-label design, consisting of 2 parts: dose-finding portion (Part 1), and~     expansion portion (Part 2). Both parts include 3 study phases: Screening Phase, Treatment~     Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with~     study treatment and completes at the Post-Treatment Visit. Approximately, 96 patients will be~     enrolled in the study.~   "
8527|NCT03455257|"~     This pilot study will test the effect of a cash transfer program aiming to improve family~     food consumption patterns, family health and schooling, with resulting benefits for childhood~     growth and cognition.~   "
8528|NCT03455244|"~     This is a prospective, observational, single-center, single-arm, clinical trial designed to~     assess the efficacy of FFRangio in measuring FFR obtained from angiography compared to~     Invasive FFR for diagnosing hemodynamically significant coronary stenosis in Multi-Vessel~     Disease.~   "
8529|NCT03455231|"~     The study wants to define the maximum tolerated dose (MTD), safety and efficacy of a short~     course radiation treatment in patients with complicated bone metastases.~   "
14358|NCT03378973|"~     This a parallel group, two-arm, randomized superiority trial that will compare the effect of~     two different doses of dexmedetomidine on motor evoked potentials during spine surgery~   "
8530|NCT03455218|"~     Open heart surgery requires the use of a cardiopulmonary bypass (CPB) circuit. As blood flows~     across the artificial surfaces of the CPB circuit, platelets are activated and consumed. This~     activation results in a profound inflammatory reaction and need for transfusion. This~     reaction is intensified in younger, smaller patients undergoing longer, more complex open~     heart surgery. Nitric oxide is naturally released by vascular endothelial surfaces and acts~     as a signaling molecule which prevents platelet activation. The investigators hypothesize~     that the addition of the nitric oxide to the sweep gas of the oxygenator during~     cardiopulmonary bypass surgery will replace this natural endothelial function and thus~     prevent platelet activation and consumption. The investigators plan to test this hypothesis~     with a pilot double blinded, randomized trial of 40 patients less than a year of age~     undergoing cardiac surgery requiring CPB.~   "
8531|NCT03455205|"~     The efficacy and safety of cancer patients in patients with gastrointestinal cancer~     (chemotherapy) in patients with gastrointestinal tumor (chemotherapy) were prospectively,~     randomized blind, multicenter clinical trials. They were randomly divided into 2 groups, test~     group Shenqifuzheng injection of 500 ml, the control group 0.9% sodium chloride injection,~     500 ml, intravenous drip, 1 times a day, 7 days post, rest is 14 days, 21 days each for a~     period of treatment, observation of two procedures. At the same time, according to the NCCN~     guide and the health ministry issued the diagnosis and treatment guidelines for cancer~     treatment. The main curative effect of the clinic was to evaluate the pretreatment of cancer~     due to the fatigue score of the patients before and after treatment -- the Piper fatigue~     revision scale was used to evaluate the Chinese version. Assess effectiveness and safety~     based on clinical assessment~   "
8532|NCT03455192|"~     The aim of this study is to evaluate the efficacy of oral administration of synbiotic tablets~     on the clinical parameters and the levels of selected inflammatory mediators in gingival~     crevicular fluid (GCF) in smokers and non-smokers with gingivitis.~      This study designed as a double-blind randomized placebo-controlled clinical trial.~   "
8533|NCT03455179|"~     Human aging is characterized by a progressive deterioration of multiple physiologic systems,~     with marked decreases in skeletal muscle mass, muscle strength, physical function and quality~     of life beginning in the sixth decade in life. These deleterious modifications have a~     significant impact upon mobility and ability to undertake daily living activities in elderly~     people. If we consider that, according to current projections, the proportion of the European~     population over 65 years will increase from 17% in 2010 to 30% in 2060 and that physical~     activity participation rates for older adults (>60 years) remain low, with only 16% meeting~     the recommendations of the American College of Sports Medicine Guidelines (11% for resistance~     training), we need to understand what type of training (strategy) can be the most effective~     for reverse physical impairments, and not only that, but which one obtains greater adherence~     and self-perception for contribute a healthier, active and more independent elderly~     population in the future.~      Thus, the purpose of this study is to investigate the effects of 20-week slow-speed~     traditional resistance training, high-speed resistance training and multicomponent training~     program with variable resistance (elastic bands) on molecular, body composition,~     neuromuscular, physical function and quality of life variables in older adults. This research~     also aims to evaluate if this novel types of training intervention (using variable~     resistances such as elastic bands in all the training programs and measure the intensity with~     the OMNI-RES perceived exertion specific for older adults) is feasible in this population,~     through analysis of adherence, intervention fidelity and self-perception reported.~   "
8534|NCT03455166|"~     Identification of possible markers associated with the onset and / or progression of~     psoriatic arthritis through comparison in patients with psoriasis alone (Ps) and patients~     with psoriasis with joint involvement (PsA), plasma levels of a panel of cytokines referable~     to the Th17 pathway , together with serum levels of MMPs, TIMPs and markers of bone~     remodeling.~      The primary objective of this study is to verify whether the arthropathy component has an~     effect on the metabolic activity of osteoblasts. This will be determined through the study of~     the differences in serum concentrations, between Ps and PsA subjects, of CTx, the parameter~     best characterized in terms of analytical variability and intra- and inter-individual~     variability, in the field of bone metabolism.~      The secondary objective is the verification of the differences in serum concentrations of the~     series of parameters specified above, in order to define a complete pattern of variations~     that can identify the molecular pathways involved in the definition of psoriatic arthropathy.~   "
8535|NCT03455153|"~     COPD is characterised by irreversible airflow limitation that is usually progressive and~     associated with an enhanced chronic inflammatory response. This inflammation can be amplified~     with flare-ups that are commonly seen in COPD patients. Pulmonary rehabilitation is one of~     the most effective methods of managing chronic obstructive pulmonary disease (COPD).~     Pulmonary rehabilitation has been seen to induce improvements in functional capacity and~     quality.~      In healthy individuals, exercise has been shown to induce an anti-inflammatory response when~     performed regularly. However, the effects of exercise on inflammation in COPD are unclear.~     Our initial CIMPRES-COPD study has looked into the effects of short-term exercise, as part of~     pulmonary rehabilitation, on inflammation. However, this trial will examine the inflammatory~     response in COPD patients who are most active following pulmonary rehabilitation against~     those who are least active.~      This study will split participants into 2 groups according to physical activity level~     following pulmonary rehabilitation. We will recruit 40 COPD patients who provided a sample in~     the initial CIMPRES-COPD study to explore inflammatory responses in those who are most active~     and least active. By better understanding the mechanisms of how long-term physical activity~     levels affects inflammation in COPD, we could design better interventions to increase~     physical activity levels following pulmonary rehabilitation.~   "
8561|NCT03454815|"~     Maintaining Apical patency during root canal treatment is a widely followed methodology in~     modern endodontic treatment protocols. It involves passing of a small #08 or #10 K file~     through the apical foramen during root canal shaping without widening it. it is done to keep~     the foramen and apical thirds of root canal free of debris. proponents of the procedure claim~     it to improve irrigation; provide better tactile feedback; reduce the chances of procedural~     errors; reduce transportation and reduce pain following root canal procedures. however, there~     is no clinical trial which specifically evaluates the effect of apical patency on outcome of~     root canal procedure. hence this study was designed to evaluate the effect of apical patency~     on outcome of root canal treatment.~   "
8536|NCT03455140|"~     PARC is an international phase I/II trial evaluating the safety and activity of pegylated~     recombinant human arginase (BCT-100) in children and young people with relapsed/refractory~     leukaemia, neuroblastoma, sarcoma and high grade gliomas (brain cancers).~      Currently the outcomes for these patients are poor and the therapeutic options are limited~     with a significant toxicity burden. Therefore new treatments which work in different ways to~     standard chemotherapy are urgently needed. Research has shown that arginine (a nutrient) is~     important in the survival of cancer cells. BCT-100 is a drug which can deplete arginine~     levels and starve cancer cells - a completely new approach. BCT-100 has been tested in adults~     and shown to be active with almost no side-effects. This trial will test whether this dose of~     BCT-100 is also safe and active in children with relapsed/refractory leukaemia,~     neuroblastoma, sarcoma and high grade glioma. The trial will also study how BCT-100 is broken~     down in the body and look for new biological markers of treatment response. Up to 64 children~     with relapsed cancers will be recruited over 2 years.~   "
8537|NCT03455127|"~     Preliminary pilot testing of the home-based FSI-ECD intervention as delivered by community~     based lay workers.~   "
8538|NCT03455114|"~     The AssiAnchor 2 is a fixation ophthalmic device. The device is manufactured by Hanita Lenses~     from PMMA material which is being used for the production of Intra-ocular lenses.~      The device is intended for patients requiring capsule centration to clip the anterior lens~     capsule between the arms of the device and secure it to the scleral wall.~   "
8539|NCT03455101|"~     This study evaluates the overall cardiovascular risk status and best predictors of optimal~     metabolic control of Turkish adult patients with diabetes mellitus.~   "
8540|NCT03455088|"~     This study is to examine whether the efficacy of DBT for BN is comparable with drug~     treatment, whether short-term and long-term efficacy of DBT combined with drug treatment of~     BN is better than single DBT or single drug treatment, and trying to explore predictable~     biological indicators of short-term and long-term efficacy of DBT for BN. Our study will use~     multi-center randomized controlled study design. 165 outpatients with BN will be recruited~     from Shanghai Mental Health Center, No.6 Hospital of Peking University and Shanghai Tongji~     Hospital. Patients with BN will be randomly divided into three groups: DBT treatment group,~     Fluoxetine treatment group, DBT combined with fluoxetine treatment group. The sample size of~     one group is 55, and then three groups will be given standard intervention for 12 weeks. To~     assess the eating disorder symptoms, impulsive and emotional change, clinical symptom scales,~     psychological scales and the security indexs will be used at baseline, 4 weeks, 8 weeks, 12~     weeks (end of treatment), 36 weeks (6 months after treatment) and 60 weeks (12 months after~     treatment follow-up). Furthermore, brain MRI will be used for DBT treatment group at~     baseline, 36 weeks and 60 weeks.~   "
8541|NCT03455075|"~     This is a Phase IIa multicenter, double-blind, placebo-controlled study in healthy men to~     evaluate the spermatogenesis suppression after oral administration of Dimethandrolone~     Undecanoate (DMAU) alone or with Levonorgestrel (LNG) for 12 weeks versus placebo alone.~   "
8542|NCT03455062|"~     In terms of immunity, pregnancy can be considered a semi-allogeneic transplant. There are~     several immunological mechanisms for implantation and maintenance of pregnancy by induction~     of tolerance without induction of immunosuppression.~      This study wants to evaluate the impact of immunodepression on women's fertility by studying~     the fertility of transplanted cardiac, renal, hepatic and pulmonary women.~   "
8543|NCT03455049|"~     Prevalence of type 2 diabetes have been increased, but medications had not been well, so that~     needed new alternatives. A new approach used in management of type 2 diabetes is incretin~     based therapy. Incretin hormone, glucagon-like peptide 1 (GLP-1) and glucose-dependent~     insulinotrophic peptide (GIP), had producted in intestine due to carbohydrate intralumen.~     After had secreted, GLP-1 had degradated by DPP-4 enzyme till number and effect had been~     decreased. Decreasing of GLP-1 effect as main defect in type 2 diabetes.~      Andrographis paniculata (A. paniculata) as traditional treatment had known since years ago to~     have hypoglycemia effect. Extract of A. paniculata consists of andrographolid and flavonoid.~     Based on study of Wooten et al that flavonoid has hydroxyl to stimulate insulin's production~     through modulated GLP-1 receptor (GLP-1 receptor ligand). So the investigators need to study~     about The Effect of A. paniculata Extract to GLP-1, Fasting Plasma Insulin, Insulin~     concentrations measured during a standardized 2-h OGTT, and HOMA-IR.~   "
8544|NCT03455036|"~     Intense itch on the legs sometimes associated with redness can be adverse effects of whole~     body vibration (WBV) according to own observations and numerous posts in non-professional~     online-blogs. To the investigators' knowledge, the appearance of itch and/or a rash during~     WBV exercise has not yet been described.~      The research objectives are:~        1. To determine the effect of WBV on itch rating and its unpleasantness and on skin~          changes.~        2. To determine the effect of WBV on immunoglobulin E (IgE) and serum tryptase~   "
8545|NCT03455023|"~     The purpose of the study is to investigate the impact of pharmaceutical care on cancer pain~     treatment for opioid-tolerant inpatients~   "
8546|NCT03455010|"~     The research question is if there is a dose-response relationship between blood biomarkers~     for articular cartilage and the magnitude of physiological load. To investigate this load~     induced biomarker change, the participants will complete a 30-minute walking test under three~     loading conditions: A: 80%, B: 100% C: 120% of their respective bodyweight (Fig. 1).~      The main biomarker we are interested in is called cartilage oligomeric matrix protein (COMP).~     Serum COMP levels are increased immediately after 30-min running but there is no~     dose-response relationship shown yet.~   "
8547|NCT03454997|"~     This is a pilot randomized clinical trial testing an implementation intervention to support~     delivery of a behavioral weight loss program at community mental health programs.~   "
8548|NCT03454984|"~     High risk MDS (Myelodysplastic Syndrome) patients will be treated with SGI-110 after~     Allogeneic Stem Cell Transplantation in the hypothesis that SGI-110 maintenance given early~     after HSCT can prevent relapse without increasing non-relapse mortality translating in an~     improved disease-free survival.~   "
8574|NCT03454633|"~     By comparing the clinical outcome of patients underwent different hypothermic circulatory~     arrest (mild hypothermic versus moderate hypothermic) during aortic arch surgery, this study~     aims to determine the optimal hypothermic circulatory arrest strategy for aortic surgery.~   "
8549|NCT03454971|"~     During the last few years, the medical care of oncohematologic cancers diagnosed patients was~     shaken by the arrival of new therapies : targeted therapies. Very efficient, these therapies~     use the oral pathway in most cases, and are taken at home. These treatments show plenty of~     drug interactions and side effects aren't rare and require, in their own, a rigorous follow~     up in order to reduce their occurrence, intensity and their impact on patients' quality of~     life. A bad management of the treatment could lead to an inacceptable toxicity, or to its~     premature interruption.~      With all the new administration and follow up strains in mind, we want to elaborate the~     medical pathway structure for these patients by reinforcing the nurse coordination and by~     integrating another healthcare professional : the hospital pharmacist, which is a~     professional especially implicated in the drug delivery, the control of drug interactions and~     medical advices relative to the given drug.~      Private healthcare professionals (referring physicians, pharmacists, private nurses),~     unsufficiently trained and informed about these new treatments and their side effects, are~     asking for further information concerning the drugs prescribed to their patients, and are~     willing to keep open a communication line for the home follow up.~      These patients, who are autonomously taking their medication, are in need to be informed and~     supported to insure the good management of the drug, while taking in account their~     environment, their knowledge of their cancer and treatment and also of all the issues that~     could occur during their therapy, in order to resolve them.~      We propose a multidisciplinary medical care taking place at the very beginning of an oral~     therapy treatment, in order to ensure the security of the drug administration. Patients and~     healthcare professionals will be closely followed during the first two treatment cycles.~     After this, side-effects incidence are less frequent and the usual oncohematologic follow up~     is sufficient.~   "
8550|NCT03454958|"~     Understanding critical periods during which people are at risk to gain weight or display~     unhealthy changes in energy balance related behaviour, i.e. eating, physical activity and~     sedentary behaviour, can facilitate the development of weight gain prevention programs.~     Although the transition to parenthood is associated with pregnancy-related weight gain and~     retention in women, evidence on the effect of having a first child on men's body weight is~     lacking. It is also unclear whether pregnancy-related weight gain and retention cohere with~     unfavourable changes in body composition and energy balance related behaviour in both women~     and men transitioning to parenthood. Using a mixed-methods design, the investigators aim to~     provide insight into this critical life phase. An observational follow-up study will be used~     to investigate changes in body weight, body composition and energy balance related behaviour~     among couples from pre-conception to one year postpartum, and to identify those most at risk~     for excessive weight gain.~   "
8551|NCT03454945|"~     Current study aims at assessing the efficacy of doxycycline as a potential treatment modality~     for early stages of MF.~   "
8552|NCT03454932|"~     Rheumatic diseases regroup a variety of disorders affecting the locomotor system including~     joints, muscles, connective tissues and soft tissues around the joints and bones.~     Inflammation and/or autoimmune reactions contribute to the aetiology of many rheumatic~     diseases. Such autoimmune conditions, commonly referred to as inflammatory rheumatic diseases~     (IRD), include arthritis of various origins such as rheumatoid arthritis (RA), psoriatic~     arthritis (PsA) or spondylarthritis (SpA). Patients with autoimmune diseases such as RA or~     SpA are in higher risk of fractures compared to the general population.~      Initial pharmacotherapies for IRD remain NSAID treatment for pain relief, and anti-resorptive~     agents (e.g., TNF-alpha blockers) which aim at reducing bone loss and preventing occurrence~     of new bone erosions. Yet current treatments may have strong side effects and are not always~     effective (e.g., 35-40% of the patients treated with TNF-alpha inhibitors will initially or~     progressively loose response). Therefore there is a need for further treatment modalities in~     IRD, which would focus on both suppressing inflammation and treating bone disorders.~      Current research studies indicate that Bone Therapeutics' allogeneic osteoblastic cells~     exhibit in vitro potent immunosuppressive and anti-inflammatory properties (in addition to~     osteo-regenerative and immune-privileged properties).~      The present research study aims at investigating in vitro the properties of these~     osteoblastic cells in the context of inflammatory rheumatic diseases. In this purpose, in~     vitro assays will be used to test these immunosuppressive effects on peripheral blood~     mononuclear cells (PBMCs) of subjects diagnosed with RA, PsA and SpA.~   "
8553|NCT03454919|"~     It is a prospective, phase II, open-labeled, clinical trial aimed to determine the efficacy~     of palbociclib in advanced melanoma patients who bear gene aberrations in cell cycle pathways~     [including CDK4 amplification and/or CCND1 amplification and/or P16 (CDKN2A) loss]. Fifteen~     patients, if there is a response then further 45 patients will be enrolled. Totally 60~     subjects with known above-mentioned gene aberrations who comply with the inclusion and~     exclusion criteria will be enrolled, their serum samples (at the time of the first~     administration of palbociclib and every 4 weeks afterwards) will be collected. Palbociclib~     will be given in the dose of 125 mg orally qd d1-21 every 28 days, unless disease progression~     or intolerance. All patients will be evaluated for the response to palbociclib by Response~     Evaluation Criteria in Solid Tumors (RECIST) at baseline. The standard radiographic imaging~     (CT scans) will be performed every 4 weeks until the end of treatment.~   "
8554|NCT03454906|"~     The aim of the study is to investigate the factors influencing hemoglobin variability with~     inflammatory and nutritional parameters and its associations with all-cause mortality among~     hemodialysis patients.~   "
8555|NCT03454893|"~     This is a multinational, open-label study to assess the efficacy and safety of AVR-RD-01 in~     approximately 8 to 12 male subjects 16 years of age or older and postpubertal with a~     confirmed diagnosis of classic Fabry disease based on deficient AGA enzyme activity who have~     not previously received treatment with enzyme replacement therapy (ERT) and/or chaperone~     therapy at the time of Screening.~   "
8556|NCT03454880|"~     The study will be a single-centre, prospective observational study to evaluate the use of a~     wearable accelerometer device to measure physical activity levels of patients within critical~     care.~   "
8557|NCT03454867|"~     Ischemic stroke is accompanied by a three to four hundred percent increase in the brain's~     extracellular fluid (ECF) and cerebrospinal fluid (CSF) concentration of glutamate, which~     diffuses and damages surrounding neurons. In this study we tested our hypothesis that blood~     glutamate levels can be reduced by hemofiltration, resulting in increased extracellular~     clearance of glutamate and attenuated neurodegeneration, and that decreased blood glutamate~     levels can provide significant neuroprotection against stroke-associated neurodegeneration,~     dysfunction and death. Our primary outcome of interest was to assess safety of hemofiltration~     in acute ischemic stroke patients.~   "
8558|NCT03454854|"~     Develop an exemplary anti-thrombotic therapy network data platform and a intelligent terminal~     application(APP), establish an new pattern used in long-time anti-thrombotic management based~     on dynamic risk evaluation, and promoted and verified by 10 thousands large sample's cohort~     study.~   "
8562|NCT03454802|"~     The aim is to describe the physiological background for PLR and the interpretation of a PLR~     manoeuvre.~      The protocol entails the measurement of stroke volume (SV) at baseline (semirecumbent patient~     position), during PLR and after returning to semirecumbent position. Simultaneously blood~     pressure (BP), pulse rate (PR), pulse oximetric saturation (SpO2) and ECG are recorded. The~     procedure is performed in ten normal subjects, ten patients recruited in the cardiology~     outpatient department and ten critically ill patients under analgosedation in the ICU.~      Analysis includes changes in measured variables and heart rate variability in the frequency~     domain during the three phases of the experiment.~   "
8563|NCT03454789|"~     Objective To investigate the onset times and duration of local anesthetic mixture solutions~     used for axillary-supraclavicular brachial plexus blocks and to compare the quality of~     anesthesia in patients with trauma of the upper limb.~      Design Randomized-prospective, observational study. Setting Perioperative, Trauma Clinic,~     University of Pecs, Hungary. Participants 85 consecutive, unpremedicated ASA physical status~     I-III patients, between the ages of 19 and 83, scheduled for trauma surgery of the hand and~     forearm.~      Interventions Patients assigned to four groups for standardized ultrasound guided~     axillary-supraclavicular block with lidocaine 1% and bupivacaine 0,5% 1:1 mixture (Group LB,~     n = 17) or bupivacaine 0.33% (Group BS, n = 14) or lidocaine 0,66% (Group LS, n = 14) or~     bupivacaine 0.5% and lidocaine 1% 2:1 mixture (Group BL, n = 40). Total target volume of 0.4~     ml/kg was administered to both groups.~      Measurements Data were collected on patient demographics, the onset times and the duration of~     actions of local anesthetic mixtures were measured, the tourniquet discomfort, vital~     parameters, pre and postoperative verbal numeric rating scale of pain intensity,~     anxiolytic/analgesic consumption and the complications were recorded. The quality of~     anesthesia was assessed by a sensory-motor-coping-pain scale (0-16).~   "
8564|NCT03454776|"~     The purpose of this study is to assess the effect of the Unloader one brace on the clinical~     symptoms of patients with knee osteoarthritis (OA) by comparing a functioning brace with a~     dummy.~   "
8565|NCT03454763|"~     Randomized Phase II Trial in sstr2 Positive Tumors to Optimize the Interval Between Cycles of~     PRRT With 177lu-dotatate~   "
8566|NCT03454750|"~     Radiometabolic Therapy (RMT) with 177Lu PSMA 617 in advanced castration resistant prostate~     cancer (CRPC): efficacy and toxicity evaluation~   "
8567|NCT03454737|"~     This is a clinical trial, unicentric, prospective, controlled, randomized, double blind~     during the experimental phase A.~      In the experimental phase B, it is contemplated to administer the experimental treatment to~     the subjects included in the group treated with P-PRP in the event that the first treatment~     would be significantly more effective, both from a clinical and regenerative point of view~   "
8568|NCT03454724|"~     This is a Multi Center Randomized Control Study of MeRes100 Sirolimus Eluting BioResorbable~     Vascular Scaffold System in treatment of approximately 484 subjects with Coronary Artery~     Disease in China. Eligible subjects shall have up to two de novo lesions in different~     epicardial vessels (One lesion in each coronary artery or it's major branch),Target lesion~     shall have visually estimated diameter stenosis ≥ 70% (or ≥ 50% and has clinical evidence of~     myocardial ischemia), lesion length ≤ 24mm, reference vascular diameter visually ≥ 2.75mm and~     ≤ 4.0mm. And subjects must meet all the study inclusion / exclusion criteria before enrolment~     in the study.All subjects shall accept clinical follow up at 1 month, 6 months, 12 months, 2~     years, 3 years, 4 years and 5 years post procedure.~   "
8569|NCT03454711|"~     Identification of the cerebral fMRI phenotype of obese patients with FA in cognitive task~     context based on food choice making~   "
8570|NCT03454698|"~     Venous leg ulcers (VLU) are slow healing wounds. They have a high recurrence rate and are~     associated with pain, infection, smell and exudate. 60% of VLU become chronic. Current~     therapeutic approaches are multifaceted and focus on improving wound healing and preventing~     recurrences. As those approaches include compression therapy, leg elevation, specific~     exercises for the foot/ ankle region and a protein rich diet/ nutrition plan a~     multidisciplinary team of health care professionals such as nursing, physiotherapy,~     occupational therapy and nutrition specialists. Most persons with VLU have a knowledge~     deficit in regards to therapeutic measures and hence have difficulties with adherence to~     treatment protocols/ management plans. It is of utmost importance, and best practice, that~     the treatment team provides effective patient education and support during the learning~     phase.~      However, there is little evidence and no published studies that describe and evaluate~     effective multidisciplinary educational interventions that target compliance/ adherence to~     the treatment plan in patients with VLU. Therefore the investigators propose to develop an~     evidence-based interprofessional educational intervention and evaluate its feasibility first~     in a pilot study and subsequently in a randomized controlled trail.~      Method/Design: Firstly, the development of an evidence based education intervention in~     collaboration with an expert panel and secondly a randomized controlled pilot study in one~     wound care outpatient clinic is proposed. Data will be analyzed using SPSS version 23.~     Univariate and bivariate analysis will be conducted according to the data level and~     distribution of the data.~      Discussion: The TIEIVLU will firstly develop an evidenced based educational intervention and~     secondly examine the feasibility of implementing this education intervention in a realistic~     care context in patients with VLU. The results will inform the final design of a following~     RCT which will examine the effectiveness of the educational intervention. An intervention~     that enhances patient adherence to therapy and hence reduces the negative outcomes of VLU~     would be beneficial to individual patients as well as society as a whole.~   "
8571|NCT03454685|"~     Relationship between human microbiota and epidemiology of lung cancer~   "
8572|NCT03454659|"~     The purpose of this study is to compare the effect of high 0.8 and low 0.4 *FiO2 ventilation~     primarily on surgical field infection and secondarily on postoperative pulmonary~     complications in patients are undergoing supratentorial craniotomy surgeons.~      *fraction of inspired oxygen~   "
8573|NCT03454646|"~     Cholinesterase inhibitors (CI) remain the only drugs with a recognized efficacy in mild to~     moderate Alzheimer's disease (AD) in spite of enormous research efforts. However, these drugs~     presented as symptomatic treatment of AD are considered as having only a weak effect on the~     course of AD. The reimbursement of these drugs is regularly challenged due to the lack of~     evidence for the impact of these drugs on milestones stages of AD evolution (survival without~     severe dementia, restriction in Basic Activities of Daily Living - BADL) and on major~     consequences in public health (hospitalization and institutionalization). The great majority~     of previous randomized controlled trials conducted with CI have had a too short duration and~     the end points were limited to cognition (ADAS Cog scale), IADL (Instrumental Activities of~     Daily Living) function and Global Impression of Change. New evidences from the DOMINO trial~     (1) conducted in UK, independently of the pharmaceutical industry, showed that the true~     effect of CI might be more to avoid or to delay the cognitive or functional decline in AD~     than to improve patients; the institutionalisation (2) was also delayed. However, this trial~     was conducted in patients with moderate to severe AD, and the interest of the drugs at the~     mild to moderate stage remains questionable.~      The investigators have shown that a good surrogate marker of survival without severe dementia~     would be an increase of ADAS Cog scale of more than six points (3). A post hoc reanalysis of~     the pivotal RCT with two CI showed that in mild to moderate patients, CI was associated with~     a 15% decrease of patients with a deterioration of ADAS-Cog of more than six points in six~     months. Thus at the beginning of dementia the real effect of CI might be more of delaying the~     cognitive and functional decline, than to improve the patients. The main objective of the SOS~     trial is to demonstrate that the benefit of CI at the early phase of dementia is the same as~     at the later phase.~   "
8579|NCT03454568|"~     In this study, the investigators are looking to understand: 1) how adults ≥ 60 years old~     thinking and memory abilities are affected by stem cell transplant; 2) whether these changes~     affect day-to-day activities and quality of life; and 3) how thinking and memory abilities~     are affected by genetics, depression, anxiety and physical function. Genetics and other~     factors may affect the brain's chemicals or structure, and may increase risk for negative~     effects on thinking and memory.~   "
8580|NCT03454555|"~     Up to one-third of Americans suffer from chronic noncancer pain (CNCP). Opioids are often~     used to treat CNCP. Once on chronic opioid therapy (COT), individuals often continue for~     months or years. Evidence for the effectiveness of COT to treat CNCP is insufficient,~     exposing individuals to known risk. Strategies are needed to reduce/eliminate COT in patients~     who are not benefiting from opioids while ensuring access for those who are.~      The researchers will employ a multisite pragmatic trial using real-time randomization to~     examine the comparative effectiveness of 2 approaches: a guideline-concordant pharmacotherapy~     approach integrated with shared decision making (SDM) (Arm 1) compared with a~     guideline-concordant pharmacotherapy approach integrated with motivational interviewing (MI)~     and cognitive behavioral therapy for chronic pain (CBT-CP) (Arm 2).~      The researchers will examine the impact of the 2 approaches on several outcomes. The study~     will examine which set of patients have greater opioid dose reduction, greater rates of~     opioid discontinuation, improved functioning, and/or lower pain scores. Clinical outcomes~     (opioid dose reduction and time to discontinuation) will be assessed using electronic health~     record data at 4 timepoints: baseline, 6 months, 12 months, and 18 months. Patient-reported~     outcomes, including physical functioning and level of pain, will be measured via patient~     survey at 3 timepoints: baseline, 3 months, and 12 months.~      The study will include patients from North Carolina and Tennessee. The researchers will~     enroll 530 patients in each study arm for a total enrollment of 1,060. This sample size will~     provide robust power to detect clinically important differences in reduction of opioid use~     between the two study arms.~      Analyses will include longitudinal (mixed effects) models to compare the change in outcomes~     from baseline to each timepoint between the two study arms. The project team will explore~     differences in the intervention effect according to participant characteristics such as age,~     sex, baseline pain level, baseline opioid dose, physical comorbidities, mental health~     comorbidities, and a history of substance abuse. Qualitative research methods will be used to~     obtain patient input on their experiences.~   "
8581|NCT03454542|"~     A comparison of two lens designs manufactured in the same material. The hypothesis is the~     subjectively rated performance of comfort, vision and lens handling will be better with the~     modified design compared to the initial design~   "
8582|NCT03454529|"~     The purpose of this pilot phase II trial is to identify the molecular and genetic mechanisms~     by which statins influence breast cancer cell proliferation. Simvastatin may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth and reduce the~     aggressiveness of breast cancer cells.~   "
8583|NCT03454516|"~     The present prospective study aims to assess the efficacy of using the telehealth solution~     Hypertension Monitor in patients with hypertension by comparison to the standard care.~   "
8584|NCT03454503|"~     The purpose of this observational study is to evaluate the effectiveness and safety of~     generic imatinib under usual clinical practice in patients of Philadelphia~     chromosome-positive (Ph+) chronic myeloid leukemia (CML) patients in chronic phase (CP) in~     Egypt~   "
8585|NCT03454490|"~     Gingival recession is defined as the apical migration of the gingival margin from the~     amelocemental junction. This condition may be associated with symptoms such as tooth~     hypersensitivity, root decay, and cosmetic complaints from patients. Many treatments have~     been used to treat gingival recession and the gold standard is the autogenous connective~     tissue gingival graft because of its predictability. This type of gingival graft is performed~     by harvesting connective tissue from patients' hard palate. Periodontists and general~     dentists frequently perform these gingival grafts. Occasionally, some patients develop~     postoperative complications that need to be addressed in an hospital setting. An uncommon but~     concerning complication of an autogenous connective tissue gingival graft is a donor site~     pseudoaneurysm of the greater palatine artery. No description of this complication following~     a gingival graft has been identified in the current literature. One case report mentioned~     that pseudoaneurysm of the greater palatine artery looks like a pulsatile nodule associated~     or not with pain on palpation. From the experience of the investigators, patients may consult~     an hospital setting having a complaint of major oral bleeding. Local hemostatic agents can~     palliate this type of bleeding, but angiographic embolization is often required. Several~     cases were treated in the investigators' hospital. Thus, the investigators believe it is~     relevant to share this experience with the scientific community. The primary objective of~     this case series is to inform dental professionals of the existence and the management of~     postoperative pseudoaneurysm of the greater palatine artery following autogenous gingival~     graft. The secondary objective is to find potential solutions to minimize the incidence of~     this morbid complication.~   "
8586|NCT03454477|"~     Comparison of endoscopic thyroidectomy, robotic thyroidectomy and conventional open surgery,~     the safety of the operation, the timing of the operation and the complications.~   "
8587|NCT03454464|"~     In accordance with the current guidelines,papillary thyroid microcarcinoma such as turmo~     invasive nerve or trachea, requires total thyroidectomy for follow-up iodine-131 treatment.In~     the course of clinical work, if the patient can achieve R0 resection, most of the patients do~     not need iodine-131 treatment,Therefore, there is no need to continue total thyroidectomy.To~     evaluate the practicable, thoroughness and Clinical value of bilateral central compartment~     dissection while preserve contrary thyroid glands.~   "
8588|NCT03454451|"~     This is a phase 1/1b open label, multicenter, dose-selection study of CPI-006, a Type 2~     humanized IgG1 antibody inhibiting enzymatic activity of CD73 and adenosine production. This~     trial will study the safety, tolerability, and anti-tumor activity of CPI-006 as a single~     agent, in combination with CPI-444, a small molecule targeting the adenosine-A2A receptor on~     immune cells, and in combination with pembrolizumab, an anti-PD1 antibody against various~     solid tumors.~   "
8598|NCT03454321|"~     Shoulder pain is a common reason for medical consultation affecting 6.7 % of the adults from~     50 to 70 years old and until 21 % of the adults over 70. Among these painful shoulders,~     rotator cuff tendinopathy represents 44 to 65% of these consultations. To treat this~     condition, patients usually receive analgesics and physical therapy. When these treatments~     are not effective, a corticosteroid sub-acromial injection is proposed. However, according to~     the literature, there is only about 50% of good response to this subacromial injection in~     rotator cuff tendinopathy. It has been suggested that the injection could be more effective~     in the presence of an inflammation over the tendons called bursitis. However, no studies have~     clearly established this. The objective of the study is to determine if the presence of a~     bursitis could be a factor of good response to corticosteroid injection. The results could~     allow us to determine which patients have the best profile to respond to subacromial~     injection. The investigators hope that these data would improve the treatment of this~     frequent disease.~   "
8589|NCT03454438|"~     Rationale: Currently, only 22% of all patients referred to the rheumatologist by primary care~     are diagnosed with an inflammatory rheumatic disease (IRD). Previous research has shown that~     structured referral sheets and community-based specialist service improve appropriateness of~     referrals.~      Objective: The aim of this study is to improve the number of effectively referred patients~     with IRD to the rheumatology outpatient clinic with either use of validated referral pro~     formas or triage of IRD by specialists in a primary care setting compared to usual care. In~     addition, the investigators want to provide tools for the general practitioner to recognise~     IRD and improve early referral of patients with IRD, and a cost-effectiveness analysis will~     be performed to evaluate the decreasing effect on health-care cost.~      Study design: Cluster randomized trial with randomization of general practitioner clinics.~      Study population: Primary care patients of 18 years or older who are suspected of an IRD and~     considered by a GP for referral to a rheumatologist.~      Intervention: One group of GPs will use a standardized referral strategy for IRD, another~     group will consist of triage by a rheumatologist in the local primary care clinic, the third~     group is usual care.~      Main study parameters/endpoints: Percentage of patients diagnosed with an IRD by a~     rheumatologists after 12 months. In addition, cost effectiveness, quality of life, work~     participation and health care costs at baseline and after 12 months.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: There is no additional risk to participating patients. Patients might benefit~     from early referral since the referral pro formas point out important aspects of IRD that are~     frequently overlooked. Patients will be requested to fill in three online questionnaires~     related to quality of life, work participation and socio-economic costs. There are no~     additional visits, physical examinations or other tests.~   "
8590|NCT03454425|"~     The objective of this study is to test the efficacy and safety of unilateral subthalamotomy~     performed using the ExAblate System for the treatment of Parkinson's disease (PD) motor~     features.~   "
8591|NCT03454412|"~     The aim of the study is to observe the effects of Intensive Neurophysiological Rehabilitation~     System on hand function in children with spastic cerebral palsy.~   "
8592|NCT03454399|"~     Image quality of intraoperative transesophageal echocardiography (TEE) tends to get worse~     during long hours of operations. An orogastric tube (OGT) is often inserted in the beginning~     of the case, and left there for intermittent suction as needed, or removed before TEE exam to~     prevent echoic artifacts. However, if left there, the effect of suction might be limited due~     to unreliable tip position of the OG tube. If removed, stomach will be distended again. We~     devised the OG tube attached TEE for practical suction and assessed its effect on image~     quality intraoperatively.~   "
8593|NCT03454386|"~     This is a pilot study to determine the efficacy of the Stress Management and Resilience~     Training (SMART) program in improving gastrointestinal and psychological symptoms,~     health-related quality of life, and satisfaction of care in patients with irritable bowel~     syndrome (IBS). Half of the participants will be enrolled in the SMART program initially. The~     other half will be placed in a self-management stress reduction program where they will read~     a popular stress reduction book over 12 weeks. Then they will have access to participate in~     the online SMART program.~   "
8594|NCT03454373|"~     This protocol is for the long term follow-up study of Comparing Food and Cash Assistance for~     HIV-Positive Men and Women on Antiretroviral Therapy (ART) in Tanzania, a 3-arm randomized~     controlled trial led by Professor Sandra McCoy at the University of California Berkeley and~     Dr. Prosper Njau at the Tanzanian Ministry of Health and Social Welfare. The investigators~     will determine the long-term effectiveness of short-term incentives for ART adherence and~     retention in care. The study will also determine whether incentives can also be used to~     re-engage PLHIV with HIV care after they have fallen out of care.~   "
8595|NCT03454360|"~     The purpose of this registry is to collect specific health and patient data to identify more~     precisely the patient population undergoing TA aortic valve replacement with the ACURATE neo™~     Aortic biprosthesis and ACURATE neo™ TA Transapical Delivery System.~      Safety and efficacy data will be collected to support the commercial use of the ACURATE neo™~     Aortic Bioprosthesis and ACURATE neo™ TA Transapical Delivery System in a specific TA~     population.~      As per IFU, the ACURATE neo™ and its ACURATE neo™ TA Delivery System are intended for use in~     minimally invasive, transcatheter aortic valve replacement using transapical access in~     patients presenting with severe aortic valve stenosis.~   "
8596|NCT03454347|"~     Following orthopedic surgery and/or injury, a significant loss of muscle mass is generally~     observed. While this loss of muscle mass appears to be the norm, it causes significant~     problems in both the athletic and general population. Athletes struggle to regain their~     performance because of the decrease in muscle mass and also have a greater potential for~     reinjury while they are in a depleted state. In the general population, and particularly~     among the elderly, this loss in muscle mass can be even more devastating because as people~     age, it is more difficult to regain muscle after it is lost. In elderly individuals, this~     loss in muscle mass can lead to significant disability, diminished quality of life along with~     an increased risk of falls. In addition to the muscle mass lost during the post-operative~     period, the strength of the muscle also decreases. This has obvious performance implications~     in athletes, as well as having the potential to extend recovery time. In the elderly,~     decreased strength may result in reduced independence and inability to perform activities of~     daily living. Many previous bed rest studies have reported that significant bone loss also~     occurs during times of decreased mechanical loading. The post-operative period generally~     results in decreased mechanical loading; however, some muscle loading will still occur during~     the rehabilitation process. The dynamic relation between muscle activity/loading and bone~     density changes in the post-operative state has not been fully described and requires further~     study.~      With this knowledge of the importance of nutrition to the musculoskeletal system, applying~     the principles of increased protein intake through the addition of a dietary supplement to a~     population preparing for orthopedic surgery and subsequent muscle disuse is a logical next~     step. The investigators hypothesize that through the consumption of a protein-based dietary~     supplement three times per day (75g protein), along with educating patients on the importance~     of consuming foods that are high in protein, there will be an attenuation of decreases in~     muscle mass and strength as well as losses in bone that occur with orthopedic injury and~     disuse. The investigators long-term goal is to identify a nutritional protocol that can be~     implemented prior to and following orthopedic surgery to diminish the deleterious effects of~     the subsequent disuse on muscle and bone.~   "
8597|NCT03454334|"~     This investigation assessed the visual performance of presbyopia and cataract patients after~     bilateral implantation of 4 distinct sorts of multifocal IOLs: At lisa tri, PanOptix, ReSTOR,~     and Symfony. The clinical results demonstrated here were excellent for four groups, however,~     there were also differences in group ReSTOR, UCVA and BCVA for the intermediate and near of~     the other groups showed less vision also symphony group for far distance demonstrated less~     vision than other groups, which may be related to their design.Multifocal IOLs demonstrated~     very good technology and unquestionably have a place in refractive surgery, whether for clear~     lens extraction or cataracts.Patients can expect excellent outcomes and surgeons can expect~     patients to be very satisfied with surgical outcomes. Four groups multifocal lenses provided~     excellent distance, intermediate and near vision, but several measures indicated that the~     PanOptix and at lisa tri lens provided better vision in all distances. Spectacle independence~     was significantly higher with four groups. Multifocal IOL design might play a role in the~     postsurgical outcome, because better results were obtained with diffractive lenses. Although~     there were differences in the results of these four lenses in the study, all of the results~     were acceptable.~   "
8639|NCT03453788|"~     This pilot study is evaluating a new smartphone application named the LETSGO app. The LETSGO~     app is designed to promote empowerment in patients after treatment for gynecological cancer.~   "
8599|NCT03454308|"~     This will be a two--arm Randomized controlled trial (RCT) design that will assess efficacy of~     the Smartphone Medication Adherence Stops Hypertension (SMASH) mobile health ( mHealth)~     program compared to an enhanced standard care (SC) program. Participants will be~     African-American (AA) hypertension patients with no other known chronic diseases.~      Participants found to have uncontrolled hypertension (HTN) and medication non-adherence via~     electronic device monitoring will be randomized to SMASH or enhanced Standard Care (SC). The~     SMASH group will receive reminders in the form of auditory and visual reminders from a pill~     monitoring device when their medication dose is due, they will monitor their blood pressure~     at home and will receive tailored motivational text messages based upon levels of adherence .~     Enhanced SC group will use the pill monitoring device without reminder functions enabled and~     will receive text messages on topics of healthy lifestyles not related to medication~     adherence and hypertension.~      The active intervention will continue for 6 months and follow-up will continue for 1 year.~   "
8600|NCT03454295|"~     The overall goal of this study is to determine the best time to offer Meaning-Centered~     Psychotherapy (MCP), an intervention that has proven to be helpful in improving spiritual~     well-being and decreasing existential distress among patients with advanced cancer, to~     caregivers. (MCP has also been shown to be an appropriate method of attending to the~     palliative or comfort care needs of caregivers of patients with cancer. Studies show that the~     psychological burden associated with caring for a patient with advanced cancer is often~     greater than that experienced by the patients themselves.) The investigators would also like~     to find out about caregivers initial impressions of MCP-C, Meaning-Centered Psychotherapy for~     Cancer Caregivers, so that the intervention can be adjusted to meet the unique needs of~     caregivers of patients with Glioblastoma.~   "
8601|NCT03454282|"~     This trial aims to assess the immunological and metabolic changes induced by the Fasting~     Mimicking Diet (FMD) in the pre-operative and post-operative setting in breast cancer and~     melanoma patients. Three cohorts of patients will be enrolled: 1) Cohort A: patients with~     resectable breast cancer (cT1N0M0 stage or cT1cN1M0-cT2cN0M0 stages not requiring~     pre-operative systemic treatment at the judgment of the investigator) who are candidate to~     curative surgery; 2) Cohort B: patients with malignant melanoma patients candidate to~     dissection of the lymph node basin because of a positive sentinel lymph node (stage~     IIIA-IIIB-IIIC); 3) Cohort C: patients with resected malignant melanoma (including~     radicalization and, in case, lymph node dissection) who are not candidate to any adjuvant~     treatment, but only to clinical and radiological follow-up (stage IIB-IIC). Patients in~     cohorts A and B will undergo one 5-days FMD cycle about 13-15 days before surgical removal of~     primary tumor (breast) or lymph nodes (breast, melanoma). Patients in cohort C will undergo 4~     consecutive FMD cycles every 28 days, starting one month after surgery.~   "
8602|NCT03454269|"~     Parkinson's disease is characterized not only by motor symptoms but also by psycho-behavioral~     symptoms including Visual Hallucinations (VH) and illusions (I), that are generally~     associated with a severe functional impairment and a bad prognosis for patients. Visual~     Hallucinations are defined by a visual perception without any real objet to perceive, whereas~     illusions are defined by a wrong perceptions of an object that is really present. In most of~     studies investigating the pathophysiology of VH in PD, no difference is made between VH and~     I, however different mechanisms could lead to the emergence of these two phenomenon, with~     different prognosis.~      Investigator hypothesize that illusions could be related to a visual impairment, maybe at the~     retinal level, known to be impaired in PD, whereas Visual hallucinations would be due to a~     more widespread impairment affecting higher levels visuo-perceptive and cognitive functions.~   "
8603|NCT03454256|"~     Impaired proprioceptive accuracy could be a risk factor for progression of gait limitations~     in knee osteoarthritis patients, even after the Total Knee Replacement (TKR). Recent studies~     on Virtual Reality (VR) in rehabilitation show its efficacy in restoring proprioceptive~     capacity, postural control and gait. However, literature lacks such studies in TKR patients.~     This preliminary study aims to evaluate the efficacy of a VR system for the enhancement of~     motor skills in TKR patients compared to a traditional approach of rehabilitation.~   "
8604|NCT03454243|"~     This is a first-in-human, open label, multicenter, dose escalation study of RXDX-106 in~     patients with locally advanced or metastatic solid tumors, who have no available therapy~     likely to convey clinical benefit.~      This study will examine the safety, tolerability, pharmacokinetics (PK), pharmacodynamics and~     preliminary efficacy of RXDX 106.~   "
8605|NCT03454230|"~     Pressure ulcers (PU) represent a major health issue because of their high incidence and of~     their important consequences. There is an important risk of pressure ulcer acquisition for~     ICU patient with acute organ failure.~      Specific risk factors identified in ICU are immobility, which accentuates the effects of~     friction and shears, as well as mechanical ventilation and the use of vasopressors.~      A repositioning schedule is a guideline for pressure ulcer prevention, but repositioning~     frequency remains unknown.~      Adaptation of the repositioning schedule to pressure ulcer risk assessment using Braden scale~     should decrease emergence of pressure ulcer. This could limit their important consequences~     for ICU patients which add to their brittle clinical condition (infection, increased length~     of stay, mortality…).~   "
8606|NCT03454217|"~     Postoperative pain is usually treated with opioids. Among them, oxycodone is popular in the~     daily practice as it is administered orally and is easily titrated. However, side-effects~     include increase duration and frequency of apneic episodes. Some authors believe that~     tramadol has less impact on these apneic episodes during the first postoperative night, based~     on a trial that reported conclusive results only during the first 2 postoperative hours. The~     objective of this randomized controlled trial is to compare the effect of postoperative pain~     treatment of oxycodone with tramadol on apneic episodes during the first and third~     postoperative nights.~   "
8607|NCT03454204|"~     Currently, administration of norepinephrine diluted at 5 µg/ml bolus or continuous infusion~     is common during sympatholysis hypotension of TCI following the elimination of hypovolemia or~     anesthetic overdosage. Continued intravenous administration must meet hemodynamic goals~     within a narrow time frame. Depending on the intensity of hypotension the dosage is variable.~     It is adjusted in real time while it is excessive or insufficient at times. Therefore, the~     development of modeling should predict the kinetic and hemodynamic effects based on dosage~     and individual.~   "
8608|NCT03454191|"~     The erector spinae plane block has been recently described as an effective analgesic~     postoperative pain treatment in case reports. It consists of injecting local anaesthetics~     below the erector spinae muscle, at the level of the transverse processes, in order to~     anaesthetize the thoracic roots coming out from the spinal cord. However, the analgesic~     efficacy has never been demonstrated in a randomized controlled trial. Therefore, the~     objective of this study is to investigate the analgesic benefit of this block on patients~     scheduled for thoracoscopy.~   "
8609|NCT03454178|"~     Background: Traditional office blood pressure (BP) measurement is often inaccurate and is~     inferior to out-of-office measurements, such as ambulatory blood pressure monitoring (ABPM),~     in predicting cardiovascular outcomes. A relatively new BP measurement method, called~     Automatic Office Blood Pressure measurement (AOBP), may provide similar BP readings to ABPM~     (latest clinical gold standard for BP measurements) and can easily be conducted in clinics.~     AOBP machines measure BP repeatedly 3-5 times with 1-min intervals and automatically provide~     the mean BP value. While AOBP was used in landmark trials (e.g. SPRINT trial) and was shown~     to eliminate white-coat effect, AOBP is rarely used in Hong Kong partly because there is no~     data concerning the accuracy of AOBP in Chinese. Almost all previous AOBP research used BpTRU~     (AOBP model), but BpTRU manufacturer was shut down permanently.~      Aim: To assess if WatchBP Office (another AOBP model) has superior diagnostic accuracy than~     traditional office BP measurements, when compared to ABPM readings.~      Method: 150 Chinese adult patients with a diagnosis of essential hypertension will be~     recruited consecutively from a Government-funded primary care clinic. All patients will have~     their BP measured by a 48-hour ABPM, a WatchBP office, and two traditional office blood~     pressure measurements.~      ABPM will be considered the gold standard; sensitivity, specificity, positive and negative~     predictive values of AOBP and traditional BP to diagnose elevated BP level, masked~     hypertension and white-coat hypertension will be calculated and compared~      Implication: if WatchBP provides closer BP readings to ABPM, this can lead to its~     implementation in routine clinical practice~   "
8610|NCT03454165|"~     A Phase I Trial of BNC105P in combination with BTK inhibitor ibrutinib in patients with~     relapsed/refractory chronic lymphocytic leukemia(CLL). This study proposes that ibrutinib~     will have far greater efficacy when it is combined with drugs that kill the CLL cells in~     peripheral circulation, thereby preventing them from returning to the protective lymph node~     niche. The study will establish the maximum tolerated dose(MTD) of the combination of BNC105P~     with ibrutinib, characterize the pharmacodynamic effects of BNC105P alone and in combination~     with ibrutinib in CLL cells, and provide preliminary assessment of the efficacy of the~     combination in CLL.~      The study consists of a Screening Period with baseline tumor assessment before BNC105P~     administration, a Treatment Period with up to six 21-day cycles and Follow-up Period.~     Subjects will receive a total of six cycles of therapy unless treatment is discontinued~   "
8611|NCT03454152|"~     Diabetic ketoacidosis (DKA) is an important complication of childhood diabetes mellitus and~     the most frequent diabetes-related cause of death in children.~      Diabetic ketoacidosis (DKA) is caused by a decrease in effective circulating insulin~     associated with increases in counter regulatory hormones including glucagon, catecholamines,~     cortisol, and growth hormone. This leads to increased glucose production by the liver and~     kidney and impaired peripheral glucose utilisation with resultant hyperglycaemia, and~     hyperosmolality. Increased lipolysis, with ketone body (beta-hydroxybutyrate, acetoacetate)~     production causes ketonaemia and metabolic acidosis. Hyperglycaemia and acidosis result in~     osmotic diuresis, dehydration, and obligate loss of electrolytes.~   "
8612|NCT03454139|"~     Percutaneous nephrolithotomy (PCNL) is a minimally- invasive procedure for removing kidney~     stones. The small incision of PCNL is performed medially from the posterior axillary line~     according to stones location. Despite the small skin incision patients suffer from~     postoperative pain due to visceral pain and intercostal nerve injury. The aim of this study~     is to evaluate the perioperative analgesic effect of subcostal transversus abdominis plane~     (TAP) block performed prior to PCNL procedure.~      Primary outcome of our study was Morphine consumption at 48th hour after the surgery.~     Secondary outcomes were perioperative fentanyl consumption; postoperative Verbal Analog Scale~     and additional analgesic drug requirement.~   "
8613|NCT03454126|"~     The primary objective of the study is to evaluate the safety and tolerability of single- and~     multiple-ascending oral doses of BIIB095 in healthy participants. The secondary objectives~     are to characterize the single- and multiple-oral-dose PK of BIIB095 in healthy participants~     and to investigate the effect of food on the single-oral-dose PK of BIIB095 in healthy~     participants.~   "
8614|NCT03454113|"~     Ellipsys Vascular Access System Registry will enroll up to 100 patients to evaluate the use~     and performance of the Ellipsys Vascular Access System when it is used within its intended~     use in accordance with standard of care in a clinical setting. The Ellipsys Vascular Access~     System is intended for use to create an arteriovenous (AV) fistula via percutaneous access.~   "
8615|NCT03454100|"~     The study evaluates the impact of a multi-sectoral intervention (water, sanitation, and~     hygiene; training on climate smart activities; care groups for mothers; market gardens) on~     the prevalence of acute malnutrition as the primary outcome using a randomized intervention~     trial between 2012-2017 with four points of data collection (2012, 2014, 2015, and 2017).~   "
8616|NCT03454087|"~     This study is a prospective single-center randomized double-blinded placebo-controlled~     clinical trial testing the effects of early enteral dextrose as a therapeutic agent in~     critically ill patients with sepsis. Primary outcomes are differences in circulating plasma~     levels of the pro-inflammatory cytokine IL-6 to be tested 24 hours after the start of enteral~     infusion. Secondary outcomes include differences in circulating incretin hormone levels,~     differences in other pro-inflammatory cytokines including IL-1β and TNF-α, changes in~     intestinal microbial composition and function after intervention, glycemic control and~     variability as assessed by capillary blood glucose measurements and exogenous insulin dosing~     during the intervention period, and clinical outcomes including intensive care unit (ICU) and~     hospital stay and in-hospital mortality.~   "
8652|NCT03453619|"~     This is a Phase II trial assessing the safety and preliminary efficacy of daily APL-2~     subcutaneous infusion administered for 16 weeks with a 6 month safety follow up, in patients~     with glomerulopathies~   "
34407|NCT03116191|"~     The purpose of this trial is to demonstrate efficacy of SK-1404 against placebo for the~     treatment of subjects with nocturia due to nocturnal polyuria, during 4 weeks of treatment.~   "
8617|NCT03454074|"~     An accumulating body of research indicates that activities such as exercise, active cognitive~     and social engagement, good sleep hygiene, stress reduction and proper nutrition are~     associated with the maintenance of cognitive health. Emerging data also suggests that healthy~     lifestyle behaviors may promote brain plasticity. Despite nationwide efforts to raise public~     awareness about brain health, there remains a gap concerning how to best promote behavioral~     change and help at-risk middle-aged and older adults adopt effective, evidence-based brain~     health behaviors into their everyday lives to maximize cognitive health. The objective of~     this study is to evaluate the efficacy of a 7-week group brain fitness intervention (B-Fit)~     for increasing preventative brain health behaviors and enhancing cognitive health in~     participants at-risk for cognitive impairment. We will also examine mechanisms of action of~     the B-Fit intervention through tracking of behavioral responses in the real-world environment~     using wearable sensors.~   "
8618|NCT03454061|"~     Unlike other European countries, Italian kindergartens do not include the physical education~     teacher in the school organic personnel. This is frequently associated with the lack of~     opportunities to perform physical education by preschool children. The aim of this study was~     to analyse the effects of a specific 16-week-long physical education programme (PEP) of~     16-week length on the development of locomotor and object control skills in preschool~     children.~   "
8619|NCT03454048|"~     This is a single-center, open label study. The primary aim of this project is to develop a~     controlled human malaria infection transmission model (CHMI-trans) or challenge model to~     evaluate the capacity of vaccines, biologics (monoclonal antibodies, or mAbs), and drugs to~     block malaria parasite transmission by assessing infectiousness of Plasmodium falciparum (Pf)~     gametocyte carriers for Anopheles mosquitoes.~   "
8620|NCT03454035|"~     This phase I study is designed to establish the safety, maximally tolerated dose (MTD) and~     recommended phase II dose (RP2D) of the ERK inhibitor ulixertinib (BVD-523) when combined~     with the CDK4/6 inhibitor palbociclib.~   "
8621|NCT03454022|"~     Successful communication between patients, caregivers, and physicians can improve how~     patients feel about their treatment. Our recent studies of older dialysis patients find,~     however, that many patients do not engage in this type of communication about treatment~     options. This study aims to determine whether the Decision-Aid for Renal Therapy (DART), a~     web-based program, can improve shared decision-making (decisions where patients are actively~     engaged) among patients, caregivers, and physicians, and improve certainty and satisfaction~     in treatment decisions.~   "
8622|NCT03454009|"~     This is a comprehensive randomized cluster hand-hygiene improvement intervention to reduce:~     self-reported acute respiratory tract infections (ARI) / influenza-like-illness (ILI) and~     gastrointestinal (GI) illness, absenteeism, presenteeism; and related behavioral and~     attitudinal change over a 90 day trial. The Intervention group will receive hand hygiene~     supplies, and a variety of educational materials, including environmental posters in common~     areas. The control group will perform their usual hygiene activities and will not receive an~     intervention.~      Identical weekly surveys will be administered to the intervention and control groups to~     measure self-reported illness, absenteeism, presenteeism, along with behavior and attitudes~     measured at specified intervals during the study. The intervention and control groups were~     randomized by work floors before the onset of the enrollment period. It is hypothesized that~     employees in the intervention group will experience reduced self-reported illness,~     absenteeism and presenteeism along with improved protective hygiene behaviors and related~     attitudes, relative to those in the control group over the 90-day trial.~   "
8623|NCT03453996|"~     Diagnostic and therapeutic cardiac catheterization procedures are important interventions to~     reduce the risk of death, avoid future cardiovascular events, and improve quality of life of~     people with heart disease. However, exposure to the radiocontrast dyes required for these~     procedures can lead to contrast-induced acute kidney injury (CI-AKI); a common and costly~     complication. There are accurate ways to identify patients at increased risk of this~     complication and strategies to prevent CI-AKI. This involves ensuring that patients who are~     at risk have procedures done with the minimum amount of X-ray contrast dye required, and that~     they receive optimal intravenous fluids at the time of the procedure.~      This study will evaluate the implementation of a strategy where computerized decision support~     tools are used to help doctors identify patients at risk of CI-AKI, as well as make decisions~     about how much contrast dye to use and how much intravenous fluid to provide to patients who~     are identified at risk of CI-AKI in cardiac catheterization.~   "
8624|NCT03453983|"~     Transcrainial direct current stimulation (tDCS) has become increasingly popular over the past~     decade. tDCS is a safe and well-studied form of non-invasive brain stimulation. The purpose~     of the current study is to see if tDCS can improve motor function in children with~     developmental coordination disorder.~      Non-invasive brain stimulation is shown to positively affect motor performance in children~     with neurodevelopmental and/or neurological conditions. For example, tDCS improves hand motor~     function in children with paediatric stroke and cerebral palsy. The benefits of tDCS in~     developmental coordination disorder is unknown. The current study will assess children's~     motor performance before and after tDCS intervention.~   "
8625|NCT03453970|"~     GOALS:~      PRIMARY:~        1. Analyze the overall impact of the proposed diabetes education program on metabolic~          control (HbA1c) and modifiable cardiovascular risk factors (lipid profile and blood~          pressure).~           SECONDARY:~        2. Evaluate the effectiveness of the program on smoking habits and body mass index (weight,~          height).~        3. Analyze the impact of the program on the quality of life related to health.~        4. Check the effect on lifestyles: compliance levels of physical exercise and adherence to~          diet mediterranean.~      DESIGN: Cluster randomized controlled trial~   "
8626|NCT03453957|"~     This study evaluates a professional development program intended to improve the relationship~     or alliance between therapists and patients/clients who are receiving psychotherapy in the~     community. Half of the participating therapists will receive training to detect and improve~     alliance with new patients while half will not. The professional development training is~     expected to improve therapists effectiveness in identifying and correcting alliance tensions~     which will, in turn, improve therapeutic outcomes for patients/clients.~   "
9346|NCT03444532|"~     This study of a randomized controlled trial aims to evaluate the feasibility of a 12-week~     sleep program and the randomized controlled trial research procedure. In total 20~     participants will be recruited and randomized to the intervention or control group.~   "
8627|NCT03453944|"~     Patients requiring prolonged time on the ventilator are susceptible to a wide range of~     clinical complications and excess mortality. It is therefore imperative for them to wean at~     the earliest possible time.~      Respiratory muscle weakness due to disuse of these muscles is a major underlying factor for~     weaning failure. Surprisingly, there is not much known about the impact of critical illness~     and MV on the expiratory abdominal wall muscles.These muscles are immediately activated as~     ventilation demands increase and are important in supporting respiratory function in patients~     with diaphragm weakness. Weakness of expiratory abdominal wall muscles will result in a~     decreased cough function and reduced ventilatory capacity. These are considerable causes of~     weaning failure and (re)hospitalisation for respiratory complications such as pneumonia.~      Recent evidence shows that neuromuscular electrical stimulation (NMES) can be used as a safe~     therapy to maintain skeletal muscle function in critically ill patients. This study will be~     the first to test the hypothesis that breath-synchronized NMES of the abdominal wall muscles~     can prevent expiratory muscle atrophy during the acute stages of MV.~   "
8628|NCT03453931|"~     The goal of this observational design is to study the effects of intravenous corticosteroids~     on heart rate variability, arrhythmias and microalbuminuria. Some previous studies have shown~     that intravenous corticosteroids could induce bradycardia but also supra-ventricular~     tachycardia and atrial fibrillation.~      A second goal of this study is to investigate whether exogenous corticosteroids may induce~     microalbuminuria. A large retrospective study has revealed an association between~     microalbuminuria and corticosteroid use in the year preceding the measurement.~   "
8629|NCT03453918|"~     Dysmetabolic iron overload syndrome and genetic hemochromatosis are frequent causes of iron~     overload. Polyphenols are efficient iron-chelators. Investigator hypothesize that polyphenol~     supplementation can reduce iron absorption in iron overload disease. Iron absorption can be~     studied by the area-under-the-curve of serum iron after iron oral loading. The primary~     outcome is the decrease of post-prandial serum iron after rich-iron meal, due to polyphenol~     supplementation.~   "
8630|NCT03453905|"~     Patients with metastases to proximal femur, who are evaluated fr the risk of pathologic~     fracture in order to decide on preventive fixation vs follow-up constitute the study~     population. The patients will be randomized in two arms. First arm - the decision of~     treatment will rely on conventional decision algorithm including specialist judgement and~     Mirels' score. Second arm- the decision on treatment will be supported by CTFEA analysis of~     bone structure and quantitative simulation-based estimate of fracture risk, in addition to~     the conventional decision algorithm. Operation rates, pathologic fracture rates and~     additional secondary outcomes will be compared between the two study arms.~   "
8631|NCT03453892|"~     Immunotherapy for the treatment of several cancer entities steadily increased during the last~     years. The data from the finalized and ongoing studies show the tremendous impact of immune~     checkpoint inhibition (ICI) also for advanced metastatic patients. Especially the ICI with~     pembrolizumab and nivolumab have an increasing number of first line treatment approvals.~     However, in particular metastatic patients which receive ICI therapy are often irradiated for~     immediate palliation of several metastases. Preclinical work revealed that radiotherapy (RT)~     is capable to modulate the tumor phenotype, its microenvironment in a way that systemic~     anti-tumor immune responses are induced. However, radiation has also immune suppressive~     properties as e.g. the expression of immune checkpoint molecules is increased following~     radiotherapy. So the ICI therapy in combination with the RT has the potential to overcome the~     immunotolerance of the tumor and the metastases. More and more reports therefore describe a~     so-called systemic immune-modulating effect of radiotherapy (former and still often named as~     abscopal effect). However the timely application of ICI and RT is often randomly and depends~     on the clinical need for the palliative RT. The aim of this trial is therefore to standardize~     the chronology of RT in combination with ICI, to evaluate the effects of radio-immunotherapy~     with a stratified and comparable patient cohort. The ST-ICI study is a prospective and~     observational study not influencing the standard therapeutic scheme and will provide hints~     how the radio-immune therapy drives systemic anti tumor responses.~   "
8632|NCT03453879|"~     The TeamOBS study is an observational study. We analyze actually recordings of obstetric~     emergencies to get an even better understanding and knowledge of the association between the~     communication and cooperation and the quality of the performance of the interdisciplinary~     team.~   "
8633|NCT03453866|"~     The purpose of this study is to determine if pre-warming of arthroscopic fluid reduces~     immediate post-surgical pain in hip arthroscopy patients. The investigators hypothesize there~     will be a significant decrease in the Visual Analog Score (VAS) measured 30 minutes~     post-operatively in the warmed fluid group compared to the control group. Secondary outcome~     measures to be collected will include VAS scores 60 minutes after surgery and on~     post-operative day (POD) one. Additionally, the investigators will collect post-operative~     temperature measured 30 and 60 minutes post-operatively as well as morphine equivalent dosing~     in PACU and at the two-week follow up visit.~   "
8634|NCT03453853|"~     To evaluate second stage safety and feasibility of Mitral Loop Cerclage(MLC) Annuloplasty~     with CSTV for repair of functional mitral regurgitation.~   "
8635|NCT03453840|"~     This project will determine the pharmacokinetic/pharmacodynamic (PK/PD) of an extended~     artemether-lumefantrine (AL) dosing regimen in HIV-infected children on efavirenz (EFV)-based~     antiretroviral therapy (ART) that is designed to improve the PK exposure and treatment~     efficacy of this artemisinins-based combination therapy (ACT) regimen. Our overarching goal~     is to inform the best treatment guidelines for young children in Africa. HIV-infected and~     HIV-uninfected children will be enrolled for intensive PK studies, as well as additional~     children for population PK studies to enhance association analyses with clinical outcomes.~   "
8636|NCT03453827|"~     To evaluate long-term intraocular lens (IOL) decentration and tilt in eyes with~     pseudoexfoliation syndrome (PES) following cataract surgery using Visante anterior segment~     OCT and iTrace Visual Function Analyzer.~   "
8637|NCT03453814|"~     The objective of this study is to administer music therapy to patients in the pediatric~     intensive care unit (PICU) in order to observe how music affects patient agitation, vital~     signs, and overall recovery in the unit.~   "
8638|NCT03453801|"~     The purpose of this study is provide a better understanding of the adaptive immune response~     to the licensed influenza vaccines in children.~   "
8640|NCT03453775|"~     We propose here to evaluate the precision of lumbar periradicular infiltration performed~     under a transverse ultrasound approach by performing a fluoroscopic control once the needle~     in the desired position. The effectiveness of the technique will be assessed by measuring~     different pain and disability scores at four weeks post-infiltration: the Visual analogue~     pain Scale score, the DN4 score, and the Oswestry disability score (ODI); The decrease in~     irradiation received will be collected, compared to that of the conventional fluoroscopic~     technique.~   "
8641|NCT03453762|"~     The investigators compare the degree of atelectasis in recovery room between conventional~     recruitment maneuver and ultrasonography-guided lung recruitment during surgery.~   "
8642|NCT03453749|"~     Introduction/Background Brain swelling/brain edema can occur due to many pathologies of the~     brain, such as infections, ischemia and trauma.~      The edema can be either primarily intra-cellular or extra-cellular. The mechanisms by which~     edema arise are not fully known but it is proposed that inside the damaged brain, fluid will~     pass over the blood-brain barrier of the vessels into the extra-cellular space. The~     accumulation of fluid will lead to an increase in distance between the cell and its closest~     capillary, which may lead to energy failure and intra-cellular edema. The extra volume of the~     fluid leads to increased intracranial pressure, which in turn leads to an increase in blood~     pressure, aggravating the edema. In addition to the physiological changes that occur, the~     edema will be increased by the immunological response to the tissue damage with release of~     pro-inflammatory cytokines that give rise to both extra- and intra-cellular edema.~      Today, no treatment has been proven efficient against traumatic brain edema. AF -~     anti-secretory factor is a 41 kDa protein that exists in humans and most animals. It was~     discovered due to its ability to inhibit experimental diarrhea.~      AF has been proven to have an effect on Mb Menière and glaucoma. In animal models, AF has~     been proven efficient in reducing increased intracranial pressure caused by trauma and virus~     infection in the brain.~      Salovum®, an egg yolk powder enriched in AF, is registered in the European Union as a medical~     food.~      Methods: 5 adult patients with severe traumatic brain injury will be included in the trial~     via next of kin consent.~      Medical interventions are protocol based. The protocol includes first, second and third~     treatment levels.~      Patients included in the trial, will receive two micro-dialysis (MD) catheters in addition to~     standard treatment. One catheter will be placed in a separate burr hole close to the ICP and~     LICOX catheter, the other MD catheter will be placed in vicinity of the damaged barin tissue.~      Patients will receive Salovum® 6 hours after trial inclusion. Patient dosage is 1g/kg body~     weight/24 hours, divided into 6 doses and administered orally, via tubing every 4 hours for 5~     consecutive days.~      Objective: Primary end-point is to investigate if Salovum® has a beneficiary effect on ICP.~      Secondary endpoints are to investigate if Salovum® has a beneficiary effect on treatment~     intensity levels (TIL), brain-oxygenation, microdialysis bio-chemistry and cytokine~     expression in plasma and microdialysate.~   "
8643|NCT03453736|"~     Studies have shown that team work impacts patients safety. This is particularly the case in~     surgical theatres where individuals from different backgrounds (surgeon, anaesthetists,~     nurses, ..etc) work together to achieve a common goal which is looking after the patient. The~     robotic theatre set up is different due to the physical separation of the surgeon from the~     patient and the rest of the team. This may represent a communication challenge. The Study~     investigators aim to study theatre staff experiences and practices of communication and~     teamwork in this special setup, investigating any challenges participants may be facing and~     possible ways of adapting to them. Staff opinions and suggestions for improvement will be~     explored for utmost surgical performance and patient safety.~      The study will involve two parts:1) individual staff interviews and 2) teamwork observations~     during real life surgery. The two parts should complement each other giving an overall~     picture of the teamwork in the robotic theatre setup.~   "
8644|NCT03453723|"~     The simplicity of the implementation and the effectiveness of hypno-analgesia (via the magic~     glove technique) has already been proven in some research work, during the installation of~     peripheral venous route. An unpublished preliminary study has shown that this method appears~     to be the most effective in preventing pain during pediatric propofol injection.~      The purpose is to compare the effectiveness of hypno-analgesia of the hand by the magic~     glove technique to lidocaine used in an extemporaneous mixture in the prevention of pain~     with injection of propofol during intravenous induction in children aged 7 to 14 years~   "
8645|NCT03453710|"~     This is a pilot study designed as a prospective, randomized controlled trial comparing~     arthroscopic Bankart repair and Remplissage with an open Latarjet coracoid transfer for the~     treatment of recurrent anterior glenohumeral instability with subcritical bone loss.~   "
8646|NCT03453697|"~     Effects of acute intermittent hypoxia on brain function imaging and systemic inflammation~      Patients with obstructive sleep apnea (OSAS) may have neurological cognitive impairment. The~     reason is not clear. Intermittent hypoxia is one of the main manifestations of OSAS.~      The investigators hypothesize that acute intermittent hypoxia (AIH) can lead to abnormal~     metabolic activity in some regions of the brain, which may be associated with systemic~     inflammation.~      The investigators proposed in 12 to 15 cases of healthy volunteers, in the form of breathing~     in the nitrogen intermittently, were observed before and after AIH MRI diffusion tensor~     imaging (DTI) changes in brain regions and at the same time understand the inflammatory~     factors and the change of oxidative stress in the human body.~      The investigators look at the data from different brain regions of the brain DTI anisotropic~     score (FA), radial diffusion coefficient (RD), axial diffusion coefficient (AD) and~     peripheral blood interleukin-6 (IL - 6), interleukin-8 (IL - 8), interleukin-10(IL - 10),~     tumor necrosis factor alpha (TNF-α), Interleukin-1 beta (IL-1β), Leptin, high sensitivity~     reactive protein‭‬‬‬‬(hsCRP), Intercellular Adhesion Molecule 1(ICAM 1),Vascular cell~     adhesion protein 1(VCAM-1) , E-selectin, endothelin-1(ET - 1),~     8-iso-PGF2α,3-nitrotyrosine(3-NT),hypoxia-inducible factor 1α(HIF 1α).~      Statistical data processing includes: the matching t test of the above indicators before and~     after AIH; The relationship between DTI and peripheral blood inflammatory factors was~     analyzed by single factor. Using DTI as the dependent variable, the peripheral blood~     inflammatory factor was analyzed by multifactor correlation.~      Ultimately, the effect of AIH on the brain's regional functions will be understood, and~     whether the effect is related to systemic inflammation.~   "
8647|NCT03453684|"~     A study of plasma and tissue vancomycin pharmacokinetics in pediatric surgical patients.~   "
8648|NCT03453671|"~     This study aims to test the effect of three cognitive strategies to affect individuals'~     subjective experience of cardiovascular exercise. Participants will be randomly assigned to~     one of three strategies to use while exercising, both during an in-person session and~     self-directed two week exercise period.~   "
8649|NCT03453658|"~     Mechanized instrumentation systems stand out amongst various devices used in modern~     Endodontics. Its use in Pediatric Dentistry, its action in primary teeth, has been in the~     center of many discussions and laboratory studies. Nevertheless, up to now, a lack of~     clinical studies on this issue can be found. Our objective is to conduct a double blinded, 2~     years follow up clinical trial to compare the success of endodontic treatment in primary~     teeth using mechanized reciprocating instrumentation to the use of manual instrumentation.~   "
8650|NCT03453645|"~     Sudden cardiac death is a frequent cause of cardiovascular mortality. Numerous rhythmic risk~     assessment criterion have been described targeting the substratum, the cardiac nervous tone~     or the trigger of arrhythmias. Development of ventricular tachycardia ablation in the past~     few years show interesting results preventing the recurrence of ventricular arrhythmias.~   "
8651|NCT03453632|"~     The investigators hypothesize that palmar injections of botulinic toxin, via an inhibition of~     the sudation, would limit the occurrence of blisters in localized epidermolysis bullosa~     simplex (LEBS).~   "
8653|NCT03453606|"~     The aim of this clinical trial is to establish the non-inferiority of home-based respiratory~     rehabilitation compared to respiratory rehabilitation in center in terms of exercise~     tolerance as evaluated by the 6 minutes Stepper test..~      This trial will also 1°) evaluate the Medico-economic aspects of the home-based Respiratory~     rehabilitation versus respiratory Rehabilitation in center; 2°) analyse the patient~     preferences between home-based respiratory rehabilitation and respiratory rehabilitation in~     center and 3°) Compare home-based respiratory rehabilitation vs respiratory rehabilitation in~     center in terms of dyspnea, quality of life, anxiety and depression.~   "
8654|NCT03453593|"~     The study aims to assess whether time to CT is associated with survival in adult trauma~     patients in an urban lower-middle income setting.~   "
8655|NCT03453580|"~     Esophageal variceal bleeding and hepatic encephalopathy are serious complications of hepatic~     cirrhosis, and they may lead to high mortality rate and severely threaten life quality of the~     patients~   "
8656|NCT03453567|"~     This study evaluated effectiveness and safety of aortic valve replacement in real-world~     clinical practice.~   "
8657|NCT03453554|"~     This study will investigate the efficacy of a smart home / digital memory notebook (DMN)~     partnership that will allow for real-time intervention and thereby facilitate acquisition and~     use of the DMN to support everyday independence. The DMN is an app that is installed on a~     mobile tablet. The smart home technology discovers and recognizes generalizable activities~     and provides information about functional status and health-related variables for older adult~     participants. This study will examine how smart home prompts affect individuals' DMN use,~     ability to maintain activity routines, and overall wellbeing. Prompts will center on helping~     users organize and schedule daily activities, record both routine and uncommon events that~     may need to be remembered, and record activities performed and important associated event~     information (e.g., when, what, where). Prompting will help to promote everyday functional~     independence by encouraging frequent and regular notebook use and reducing memory~     difficulties. The DMN will also help to support functional independence by notifying~     individuals about appointments or prompting individuals to initiate important activities of~     daily living (e.g., take medications).~      This study will also involve a machine learning technique to gain a better understanding of~     the contexts in which individuals adhere or do not adhere to the prompts. This activity-aware~     intervention will be deployed in the homes of older adults with memory difficulties, to~     assess the usability of the technology as well as to evaluate in a naturalistic setting the~     efficacy of the technology for increasing everyday functional independence and quality of~     life and decreasing care-partner burden. This contribution is significant because it will~     demonstrate that intelligent technologies can improve the efficacy of traditional memory~     rehabilitation techniques, extend functional independence, reduce caregiver burden, and~     improve quality of life.~   "
8658|NCT03453541|"~     This prospective, randomized, double blinded study is designed to compare the bleeding rates~     of ketorolac vs. placebo when used for post tonsillectomy pain control in pediatric patients~     ages 2-18.~   "
8659|NCT03453528|"~     Single-centre, prospective, diagnostic trial to evaluate the Prostate-Specific Membrane~     Antigen (PSMA-antigen) over-expression in metastatic castration resistant prostate cancer~     (mCRPC) and in advanced/metastatic solid tumors patients.~   "
8660|NCT03453515|"~     This study evaluates an educational web-based intervention designed to increase adolescent~     boys' and girls' motivation and skills to engage in safer sexual behavior (HEART: Health~     Education and Relationship Training). Half of participants will receive HEART and half of~     participants will receive Growing Minds, an attention-matched control website focused on~     growth mindsets of intelligence and self-regulation. The ultimate goal of this work is to~     help youth reduce their risk of HIV and other sexually transmitted diseases and to avoid~     unplanned pregnancies.~   "
8661|NCT03453502|"~     Twenty-seven hospitals in China will participate in the study, which aims to increase~     breastfeeding rate in the neonatal intensive care unit (NICU) and reduce the clinical~     complications in very low birth weight infants and extremely low birth weight infants.~   "
8662|NCT03453489|"~     This pilot trial studies how well telotristat etiprate works in treating participants with~     well differentiated neuroendocrine neoplasm that has spread to other places in the body and~     monitored by carbon C 11 alpha-methyltryptophan (AMT)-emission tomography (PET). Telotristat~     etiprate may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Studying the changes within the tumor cells via AMT-PET may help doctors better~     understand how tumors respond to treatment with telotristat etiprate.~   "
8663|NCT03453476|"~     Systemically healthy periodontitis patients were recruited in this single-blind, split-mouth,~     randomized controlled clinical trial. After SRP, PDT was applied at probing depth (PD) ≥ 4 mm~     at test quadrant. At baseline, 3rd month and 6th month, clinical parameters and cytokine~     pattern in gingival crevicular fluids (GCFs) were analysed.~   "
8664|NCT03453463|"~     The study determined the effects of predominately resistance type exercise on parameters of~     sarcopenia and osteopenia (sarco-osteopenia) in older, community dwelling men with~     sarco-osteopenia over 18 months.~   "
8665|NCT03453450|"~     This study is meant to evaluate the Health TAPESTRY volunteer program. The objective of this~     study is to explore volunteer experiences in Health TAPESTRY in terms of implementation and~     to understand how participation in Health TAPESTRY as a volunteer is related to compassion,~     self-reported physical activity, quality of life, and attitudes toward older adults.~   "
8666|NCT03453437|"~     The study is a randomized controlled study. A total of 200 students will be invited to~     participate in a 5-session mindful self-compassion course aimed at increasing self-compassion~     and reducing maladaptive perfectionism, anxiety, depression, and unhealthy body image.~     Self-compassion is the ability to show oneself kindness in instances of perceived inadequacy,~     failure, and suffering by attending to distressing experiences with kindness, mindfulness,~     and the ability to recognize these as a part of a shared humanity. Twelve participants will~     be randomly selected for pre- and post interviews to qualitatively evaluate outcome. Ten~     participants with high perfectionistic tendencies will be selected to participate in a~     narrative life story interview.~   "
8667|NCT03453424|"~     Dexmedetomidine if add to patient controlled epidural analgesia for patients undergoing major~     abdominal cancer surgery may improve its effects.~   "
8668|NCT03453411|"~     The main objective of this project is to evaluate the effects sought and the effects felt by~     children when EMONO is used in pediatric dental care. The Investigators will try to~     characterize the children who have submitted a request to extend contact with EMONO. The~     maintenance of a framework for the safe use of this drug whose place in dental care is~     fundamental and the benefit ratio is very favorable is essential.~   "
8681|NCT03453242|"~     The study of this study is to evaluate the age influence on cortical bone strength properties~     by two methods:HR-pQCT (HighResolution-peripheral quantitativeComputedTomography) and~     ultrasound. The main objective consists in the evaluation of the age influence on cortical~     thickness at 1/3 distal radius measured by US.~   "
8669|NCT03453398|"~     Shift work deeply impacts on temporal organization leading to a circadian desynchronization,~     which translates into a worsening of the sleep quality and work ability during waking hours.~     Furthermore, also the fine motor control skills and the subjective mood profile could undergo~     modifications in relation to the acquired sleep debt. The misalignment between working time~     and physiological/behavioral functions could have negative influences on the levels of~     spontaneous daily activity, with possible alteration of the activity-rest rhythm of the~     worker, especially in clinics.~      In relation to the participants' chronotype, the aim of this project will be to evaluate the~     effect of irregular working hours (shift work) on (i) the sleep quality, (ii) the circadian~     rhythm of activity levels and, (iii) the motor control. These assessments will help to~     identify the shift type with less impact on the health status in a nurse cohort.~   "
8670|NCT03453385|"~     The purpose of this study is to measure changes in smoking behavior during and following~     sampling of an e-cigarette product. E-cigarettes are classified by the US Food and Drug~     Administration (FDA) as a tobacco product, though they contain no tobacco. Unlike regular~     cigarettes, which are burned (creating smoke that is inhaled), e-cigarettes include a heating~     element that vaporizes nicotine. E-cigarettes are likely much safer than conventional~     cigarettes, but they may not be entirely safe. We are testing the effects of one specific~     ecigarette (NJoy) on naturalistic changes in smoking behavior. Neither the tobacco industry~     nor any ecigarette manufacturer provides support of any kind to this study. There is no~     requirement to quit smoking in this study, nor is there any requirement to use e-cigarettes.~   "
8671|NCT03453372|"~     A double-blind placebo-controlled randomized clinical trial to evaluate the efficacy of~     magnetic resonance-guided focused ultrasound surgery (MRgFUS) in the treatment of pain caused~     by knee osteoarthritis (OA)~   "
8672|NCT03453359|"~     The aim of the study is to compare the monitoring of anesthetic depth in colonoscopies using~     the bispectral index monitor versus conventional monitoring as a guide for sedation, allowing~     to offer the best care in terms of patient safety. The investigators will choose non-obese~     adult patients without many pathologies and with intact neurological capacity. They must~     voluntarily participate in the study and sign the informed consent designed specifically for~     the study. The main hypothesis is that the percentage of optimal sedation in the group of~     patients guided by the monitoring of the bispectral index will be 20% higher than in the~     group guided in a conventional manner. The investigators expect significant differences in~     the incidence of complications, total dose of drugs and need for rescue medication. There~     will be no significant difference in the satisfaction with the colonoscopy.~   "
8673|NCT03453346|"~     This study aimed to evaluate the safety and efficacy of generic sofosbuvir, an~     investigational anti-hepatitis C virus (HCV) drug, combined with weight-adjusted ribavirin~     for treatment-naive Chinese adults chronically infected with genotype 2 HCV, the second most~     prevalent genotype in China. One hundred and thirty-two (132) subjects, including one hundred~     and twenty (120) non-cirrhotics and twelve (12) compensatory cirrhotics, were medicated with~     sofosbuvir 400 mg daily combined with weight-adjusted ribavirin 1000-1200 mg daily. The~     treatment course lasted 12 successive weeks and thereafter all the study participants entered~     into a 12-week treatment-free follow-up period.~   "
8674|NCT03453333|"~     Lack of depth perception and spatial orientation are drawbacks of laparoscopic surgery. The~     advent of the three-dimensional (3D) camera system enables surgeons to regain binocular~     vision. The aim of this study was to gain subjective and objective data to determine whether~     3D systems are superior to two-dimensional (2D) systems.~   "
8675|NCT03453320|"~     Treatment with colloidal solutions has during long time been a cornerstone within intensive~     care. Lately there has been a shift from synthetic colloids to natural albumine.~      One of these solutions is the hyperoncotic Albumin 20%. There are however still several~     aspects of the physiological effects of hyperoncotic albumin, that are not known.~      In this study the main object is to study with what rate hyperoncotic albumin should be~     administered. Rapidly 30 minutes or slower 120 minutes.~   "
8676|NCT03453307|"~     This clinical study aims to evaluate the feasibility to predict clinical response of target~     therapy or chemotherapy drugs based on the ex vivo drug sensitivity data using~     patient-derived organoids.~   "
8677|NCT03453294|"~     Oxygenation with high-flow nasal cannula with 100% oxygen have now been evaluated in a number~     of studies and the data are convincing. The THRIVE technique is able to oxygenate patients~     safely and vital parameters has been shown to be stable. But it is of great importance to~     evaluate this new concept regarding other potential negative physiological aspects such as~     biological stress response detected by blood-bourne biomarkers before implementing it into~     clinical practice.~   "
8678|NCT03453281|"~     This is a one month pre post intervention study. Subjects with diabetic macular edema were~     given intravitreal anti VEGF (Aflibercept) injection. Central retinal thickness, macular~     electrophysiology, and visual acuity were observed one week and one month after injection was~     given to the eye to describe early anatomical, physiological, and clinical changes. We~     hypothesized that changes to these outcomes can be found and documented.~   "
8679|NCT03453268|"~     The investigators hypothesize that a gradual reduction in antihypertensive treatment in~     nursing home (NH) patients with low systolic blood pressure (SBP) can improve survival~     through a controlled increase in SBP and a decrease in secondary morbidity due to~     'overmedication'.~      Accordingly, the investigators propose a randomized, case/control trial in NH patients ≥ 80~     years with a SBP<130 mmHg with >1 anti-Htn drugs. This trial will consist of two parallel~     arms: the intervention arm will entail antihypertensive drug step‐down, while the control arm~     will comprise the standard anti‐hypertensive treatment.~   "
8680|NCT03453255|"~     Acute myelocytic leukemia ( AML) is a highly heterogeneous group of malignant hematopathy.~     Chromosomal translocation with t (8; 21) (q22; q22) , about 10 ~ 15% incidence in AML and 40%~     incidence in the AML-M2 type of leukemia, is a karyotype that is considered to have a good~     prognosis. The National Comprehensive Cancer Network (NCCN) guidelines recommend that~     high-dose Ara-c regimens may benefit for patients, but with 30 to 40% relapse and serious~     risks on myelosuppression, infection and bleeding in high-dose Ara-c consolidation~     chemotherapy and more than 70% recurrence rate with （tyrosine kinase）KIT mutation. So the~     exploration of a relatively safe and efficient consolidation therapy is one of the difficult~     problems to be solved in the treatment of mitigatory t (8; 21) AML.~   "
8682|NCT03453229|"~     The present study will be a prospective non-interventional study involving 15 to 20 lung~     transplant patients. The patient will do as usual Forced Expiratory Volume (FEV1) measures~     and some physiological parameters will be automatically recorded through the wearable and~     wireless sensors. The spirometer will also be connected but only to transmit stored data, not~     for real time use. The patient and the physician will not have access to the data until the~     end of the study. The 6 following physiological parameters will be recorded: heart rate,~     respiratory rate, body temperature, SPO2, motion, and sleep. The study duration for each~     patient will be 6 months.~      The primary endpoint will be the number of FEV1 measures combined with physiological~     parameters. This primary endpoint has been chosen because it is easy to obtain. The secondary~     endpoints will be: - physiological parameters associated with a 10% or higher decrease in~     FEV1, - correlation between variations of physiological parameters and occurrence of a~     clinical event (defined by presumption of infection or of graft failure), - interval between~     the first significant modification of each physiological parameter and the onset of an event,~     - number of recorded values, - patient's satisfaction. In this pilot phase, there is no real~     time health advice.~   "
8683|NCT03453216|"~     In a recent study, investigators provided the first neuroscientific data on social~     facilitation. This neuroimaging study, performed in the macaque monkey, shows a marked~     improvement in performance in a simple task when a congener is present compared to when the~     animal performs the task alone. This social facilitation is accompanied by a significant~     increase in brain activity within the fronto-parietal network of attention. No variation in~     activity, however, is observed in the cerebral network of motivation. These results argue in~     favor of the implication of attentional processes in the phenomenon of social facilitation.~     The challenge now is to determine whether social facilitation is always based on the~     attention network (whatever the task) or, alternatively, whether it increases activity in any~     cerebral circuit involved depending on the task performed and the population studied. This~     hypothesis, which the investigators have named the multi-mediator model of social~     facilitation, has the advantage of reconciling the attentional and motivational theories of~     social facilitation, which are not mutually exclusive. This hypothesis also provides an~     explanation for the pervasiveness (across species and different ages for humans) of social~     facilitation. The main objective of SOFEE is to gather neuroscientific evidence to support~     the multi-facilitator model of social facilitation.~   "
8684|NCT03453203|"~     Chronic migraine (CM) is defined as a headache that occurs more than 15 days per month, which~     has the features of migraine headache on at least 8 days per month.1 The cause of CM is not~     well understood. Many patients with CM appear to have associated musculoskeletal neck pain.~     The purpose of this study is to treat cervicalgia in patients with migraine and to look for~     improvement in migraine frequency and intensity. Osteopathic manipulative treatment (OMT) can~     diagnose and treat common musculoskeletal dysfunction. This may break facilitation within the~     nervous system and reduce musculoskeletal pain which subsequently will reduce headache~     frequency. This will be a randomized controlled trail comparing patients with CM treated with~     OMT vs no treatment. The investigators will look at the frequency of migraine days before and~     after the treatment period to determine migraine frequency and improvement.~   "
8685|NCT03453190|"~     Researchers want to find out if giving the drug Apremilast in combination with Clobetasol~     spray can help people clear their moderate to severe plaque psoriasis quicker than if~     Apremilast is used by itself.~   "
8686|NCT03453177|"~     Neonatal sepsis has a high risk of morbidity and mortality. The current WHO and national~     guidelines recommend antibiotics to which resistance is reported in neonatal populations,~     although the available data is limited. Research on alternative empirical regimens for~     neonatal sepsis which are affordable, safe and cost-effective, with a step-down oral option,~     is needed. AMR is an issue of global public health concern and is one of the WHO's global~     health priority areas. Understanding the benefits, risks, MIC capacity and PK of fosfomycin~     will influence global policy on the case management of neonates with sepsis in Kenya and~     international settings.~   "
8687|NCT03453164|"~     This study aims to evaluate safety and efficacy of nivolumab (anti-PD-1 antibody), which is~     approved as tertiary therapy, and neoadjuvant short-term limited local radiotherapy in~     patients with unresectable recurrent gastric cancer who progressed (SD or PD) after standard~     treatment (primary and secondary chemotherapy) and have more than one lesion assessable in~     diagnostic imaging (one lesion must be >=2cm).~   "
8688|NCT03453151|"~     Patients with chronic heart failure and undergoing right heart catheterization will be~     enrolled in this study. Subjects will undergo catheterization of the heart to obtain central~     cardiac pressure and other cardiac hemodynamic parameters. Subsequently, the subject will~     undergo a regional nerve block of the splanchnic nerves.~      This study will be a prospective, uncontrolled clinical trial. The study will not be~     controlled as invasive monitoring of hemodynamics will be performed, allowing clear~     demonstration of a cause-effect relationship. The goal of the study is to provide proof of~     concept.~      Patients will undergo detailed physiological testing.~   "
8689|NCT03453138|"~     LMA Protector is a recently developed second generation laryngeal mask several kinds of~     different laryngeal masks were used for the airway management during laparoscopic surgeries.~     However there is a lack of knowledge for the use of LMA Protector during laparoscopic surgery~     .In this study researchers aim to determine the effectivity of LMA Protector and plan to~     analyse the orofaryngeal cuff pressure and fiberoptic grading scale measurements .~   "
8690|NCT03453125|"~     The goal of this study is to establish that a memory retraining protocol, originally~     developed for English-speakers, and translated into Spanish, is effective.~   "
8691|NCT03453112|"~     The purpose of this study is to demonstrate the non-inferiority of Foster 100/6mg NEXThaler~     versus Foster 100/6mg pMDI in terms of pulmonary function in asthmatic patients, as well as~     the effect of the test treatments in terms of additional lung function parameters and~     clinical outcome measures. The purpose is also to assess the safety and tolerability.~   "
8692|NCT03453099|"~     The investigators aim to understand the effect of a caffeine intake, sleep habits, anxiety~     about surgery, alcohol intake and smoking status upon the dose of the anaesthetic drug,~     propofol, required for anaesthetic induction.~   "
8693|NCT03453086|"~     The investigators hypothesize that the analgesic efficacy of ultrasound-guided serratus~     anterior plane block will provide better analgesia with fewer complications in comparison to~     ultrasound guided thoracic paravertebral block~   "
8696|NCT03453047|"~     Several neurological problems which include both central nervous system and peripheral~     nervous system can occur as a result of acute liver failure or severe chronic liver failure.~     The main reason of cerebral damage in liver failure is cellular metabolic changes, long term~     neuro-inflammation status, activation of brain microglia, accumulation of manganese and~     ammonia besides acute and severe hyperammoniemia that triggers systemic inflammation.~     Examples of neurological complications of serious hepatocellular failure are hepatic~     encephalopathy, diffuse brain edema, Wilson disease, hepatic myelopathy, acquired~     hepatocerebral degeneration; Parkinsonism induced cirrhosis and osmatic demyelinization.~     Attentive neurological evaluation is of high importance in order to define seriousness level~     and distribution of neurologic disorders besides current treatable anomalies and potentially~     prescribe postoperative prognosis.~      S100β is released by astrocytes in brain damage. S100β increases in the beginning of brain~     damage so it can be used to diagnose early stage brain damage. Neuron specific enolase (NSE)~     acts as intracytoplasmic enzyme and increases serum levels in neuron damage.~      The aim of the study is to evaluate neurological damage and analyze its effect on prognosis~     by considering S100β and NSE levels in liver transplantation.~   "
8697|NCT03453034|"~     Study of Tolerance and Pharmacokinetics of TQ-B3233 Capsule, phase I,single arm.~   "
8698|NCT03453021|"~     The primary objective of the study is to measure the effect of mepolizumab on declines in~     oral corticosteroid therapy (prednisolone or prednisone) in patients with severe eosinophilic~     asthma.~      Asthma is a chronic inflammatory disease of the airways that affects 5 to 10% of adults and~     children. Despite current treatments that are often effective, 10% of patients are not~     controlled by inhaled therapies. These severe asthma require regular use of systemic~     corticosteroids in 30 to 40% of cases. In this context, the use of glucocorticoids is~     associated with many more or less serious adverse effects, but still affecting the patient's~     quality of life. Several treatments have already been proven to save systemic steroids~     (theophylline, anti-leukotrienes, golimumab ...). On the other hand, none is currently~     recommended because of a risk / benefit ratio that is too high.~      Mepolizumab is a human monoclonal antibody that binds to and inactivates interleukin 5. It~     has recently been shown to be effective in reducing the daily dose of oral corticosteroids~     and in reducing exacerbations in these patients with severe eosinophilic asthma. It also~     reduces the number of eosinophils in the blood and sputum and improves the quality of life.~      Patients will receive a subcutaneous injection of 100mg mepolizumab every 4 weeks for one~     year, for a total of 12 injections.~      In France, this treatment was subject to a Temporary Authorization for Nominative Use in~     severe eosinophilic asthma and is reserved for hospital use.~      The injections will be done in HDJ Pneumology CHU Grenoble Alpes and patients will be~     followed monthly during injections.~   "
8699|NCT03453008|"~     Following a stroke , 55% of the patients do not recover any traction of the upper limb and~     30% a residual motricity not allowing a functional grip. For this last group of patients,~     there are major therapeutic issues to restore a functional grip.~      The aim of the study is to relieved the spastic cocontractions before and after usual~     injection of botulinum toxin A at stroke patient.~   "
8700|NCT03452995|"~     Aim of the study: To evaluate the efficacy of lymphatic drainage treatment associated with~     the application of kinesiotaping in the reduction of lymphedema, pain and in the recovery of~     knee joint ROM in patients undergoing surgery of total knee arthroplasty in osteoarthritis.~      Inclusion criteria: Operated patients of total primary knee arthroplasty in osteoarthritis~     not later than 5 days after surgery, Patients of both sexes aged between 65 and 85, Presence~     of lymphedema and volumetric difference with the contralateral limb of the cirtometry equal~     or greater than 3 cm.~      Exclusion criteria: Patients operated for re-implantation or revision, presence of~     inflammatory, neurological, important cardiological diseases and active tumor pathologies,~     absence of DVT of the lower limb.~      Study design: Prospective, open, randomized, lasting 12 months GROUP 1 (33 pts) KINESIOTAPING~     + STANDARD REHABILITATION GROUP 2 (33 pts) LYMPHODRAINAGE+ STANDARD REHABILITATION GROUP 3~     (33 pts) KINESIOTAPING + LYMPHODRAINAGE + STANDARD REHABILITATION Outcome measures: Pain:~     evaluation with NRS scale 0-10, Edema: cirtometric evaluation (in 4 standard points), ROM:~     goniometric measurement of the knee joint excursion. All measures at the beginning and end of~     treatment (6 days).~   "
8701|NCT03452982|"~     This research study evaluates the concordance of the result between two diagnostic tests:~     Sentinel node and Pelvic-para-aortic lymphadenectomy in patients with ovarian cancer.~   "
8702|NCT03452969|"~     To evaluate visual outcomes of a segmental refractive multifocal intraocular lens (IOL) after~     cataract surgery.~   "
8703|NCT03452956|"~     This is an observational study that aims to better understand the genetic causes of~     frontotemporal degeneration (FTD), Multiple Systems Atrophy (MSA), and Progressive~     Supranuclear Palsy (PSP). It is hoped the information gathered in this study will help lead~     to better diagnostics and future treatments.~   "
8704|NCT03452943|"~     This is a study to evaluate the efficacy and safety of deutetrabenazine (TEV-50717) tablets~     for the reduction of motor and phonic tics associated with TS in children and adolescents 6~     through 16 years of age.~   "
8705|NCT03452930|"~     The goal of this clinical research study is to find the highest tolerable dose of EDO-S101~     that can be given with or after radiation therapy to patients with glioblastoma. The safety~     of this study drug will also be studied.~      This is an investigational study. EDO-S101 is not FDA approved or commercially available for~     the treatment of glioblastoma. It is currently being used for research purposes only.~      The study doctor can describe how the study drug is designed to work.~      Up to 128 participants will be enrolled in this study. All will take part at MD Anderson.~   "
8706|NCT03452917|"~     In this clinical study, a total of 1500 patients with out-of-hospital cardiac arrest in~     Seattle/King County will be enrolled. This will be a randomized clinical trial and patients~     will receive either two different doses of IV sodium nitrite (45 mg or 60 mg) or placebo~     during resuscitation in the field by paramedics. The primary safety outcome will be~     proportion of patients surviving to hospital admission and primary efficacy outcome will be~     survival to discharge.~   "
8730|NCT03452605|"~     Type 1 Diabetes (T1D) is associated with microvascular changes in the brain, which can cause~     cognitive dysfunction. Cocoa flavanols (CF) can stimulate vasodilation, resulting in enhanced~     cerebral blood flow and better cognitive function. This study aimed to investigate whether~     acute CF supplementation can improve cognitive function and the hemodynamic (BOLD) response~     in T1D patients.~   "
8707|NCT03452904|"~     Drug-eluting stent (DES) has been the primary choice for in suit coronary lesions treatment.~     In comparison to bare-metal stent (BMS), it evidently decreases the rate of restenosis.~     However, in recent years in-stent restenosis or thrombogenesis caused by acquired stent~     malapposition in the late stage or by new in-stent atherosclerotic plaques was oberved, which~     possibly was associated with chronic inflammation stimulation because of residual~     intravascular metal or polymer coating. Through being expanded around 30 to 60 seconds,~     drug-coated balloon (DCB) can ensure adequate paclitaxel enter the artery wall, which can~     inhibit smooth muscle cells hyperplasia without remaining any foreign body. In recent small~     sample trials, they showed that sole DCB treatment had a good long-term effect when~     pre-treating ideal in suit coronary lesions (defined as residual stenosis< 30%, without~     dissection severer than type C, anterograde flow TIMI III). In PEPCAD I trial, the rate of~     major adverse cardiovascular events (MACE) was 6.1% in the first 12 months and persistent to~     3-year follow up. Small sample prospective observational study from Korea, like Shin, showed~     that in the in suit coronary lesions with the fractional flow reserve (FFR)>0.85 after~     percutaneous transluminal coronary angioplasty (PTCA), the FFR kept unchanged in the 9-month~     follow up after DCB treatment and there was not MACE happened. However, so far randomized~     controlled trials with large sample to confirm their non-inferiority compared with DES when~     treating relatively larger in suit coronary lesions are lacked. Meanwhile, a number of~     doctors worried about acute cardiovascular occlusion and long-term restenosis. In this study,~     we assume that in the in suit coronary lesions with FFR>0.85 after PTCA pre-treatment, DCB~     treatment is not inferior to DES treatment regarding to middle- and long-term functional~     recovery.~   "
8708|NCT03452891|"~     The purpose of this study is to determine of local application of commericially-available,~     FDA-approved preparation of simvastatin is effective in increasing clinical attachment levels~     (primary outcome), as well as alveolar bone (secondary outcome) compared to standard~     mechanical therapy in patients on periodontal maintenance therapy (PMT). Subjects undergoing~     PMT at the UNMC College of Dentistry clinics will be recruited to participate in the~     randomized one-year clinical trial based on the following eligibility criteria: 1) diagnosis~     of chronic advanced periodontitis (generalized or localized), 2) participating in regular PMT~     visits (3-6) month intervals), 3) no systemic diseases or medication which significantly~     impact periodontal inflammation or bone turnover (e.g. steroids, bisphosphonates, > 325 mg~     aspirin/day and in good general health, 4) one experimental quadrant of the mouth with an~     inflamed 6-9 mm interproximal posterior periodontal pocket with history of bleeding on~     probing (BOP), 5) willingness to sign consent form. Subjects will be divided into two groups~     for additional therapy in a 6-9 mm interproximal periodontal pocket at baseline: 1) local~     anesthesia and mini-flap reflection with subgingival mechanical debridement plus application~     of the simvastatin-methylcellulose gel or 2) local anesthesia and mini-flap reflection with~     subgingival mechanical debridement plus application of saline. Samples/measurement will be~     obtained at the designated experimental site at baseline, 2 weeks, 6 and 12 months during~     PMT: 1) digital radiographs (baseline and 12 months only; bone height measurements), 2)~     presence of explorer-detectable supragingival plaque, 3) 30-second gingival crevicular fluid~     (GCF) sample (markers of inflammation, bone turnover), 4) recession from the cemento-enamel~     junction, 5) probing pocket depth and bleeding on probing (BOP). Following the 12-month~     visit, the research-specific intervention and measurements in the experiment quadrant will be~     removed from routine PMT.~   "
8709|NCT03452878|"~     Aggressiveness has a high prevalence in the psychiatry population and is of major concern.~     Though pharmacological treatments are effective for most patients, there is a portion that~     doesn't respond properly and is considered medically refractory. For them, surgical~     procedures (i.e. stereotactic lesions) have been performed as an attempt to reintegrate~     patient into society. The amygdala is a main structure in the control of aggressive behavior~     and amygdala lesion could improve behavior without neurological or other behavioral~     impairment. In this study, it will evaluate the functional results of the bilateral amygdala~     lesion of aggressive refractory patients through neuroimaging, clinical assessment and blood~     hormonal levels. To better understand the neurobiology of aggression, aggressive patients~     that are not refractory will also be studied through neuroimaging and hormonal levels.~   "
8710|NCT03452865|"~     Sepsis is a severe disease with a high mortality rate and lack of efficacious therapies.~     Proton pump inhibitors (PPI) are drugs widely used to inhibit acid secretion by gastric cells~     and with a high safety profile. The investigators have recently reported that PPI, such as~     esomeprazole, inhibit TNF-alfa and IL-1ß secretion. Moreover, we showed that a single~     administration of PPI protects mice from endotoxic shock with no adverse effects. PPI-SEPSIS~     is a randomized, double blind, controlled against placebo clinical trial to test if~     high-doses esomeprazole in septic patients reduces the severity of organs failure.~      In parallel, the investigators will evaluate ex vivo in monocytes from septic patients: redox~     state and response to inflammatory stimuli; ATP release; metabolic changes and pH; cytokine~     production; the effects of PPI on these parameters.~   "
8711|NCT03452852|"~     The single center, prospective, randomized trial includes in total 60 patients. We want to~     compare two different treatment methods for compression therapy for split thickness skin~     graft in lower leg. The patients are randomized to compression therapy with NPWT (negative~     pressure wound therapy) using the device PICO or using the compression bandage with Coban 2~     lite.~      Primary outcome is complete healing of the skin transplant 30 days postoperatively. Secondary~     outcomes will be to note frequency of infection, bleeding, loss of transplant etc.~   "
8712|NCT03452839|"~     This study arises from the need to optimize antibacterial drug usage to face increasing drug~     resistance among gram-negative pathogens in intensive care units. Gram-negative organisms are~     responsible for 70% of drug-resistant infections acquired in the intensive care unit.~     Meropenem is a β-lactam, carbapenem, antibacterial agent usually administered by intermittent~     infusion. As β-lactam efficacy is determined by the time in which the drug concentration~     exceeds the minimum inhibiting concentration of the target pathogen, intermittent infusion of~     this short half-lived drug can lead to precipitous drops in serum drug levels, an occurrence~     linked to emergence of resistant pathogens. The investigators hypothesize a beneficial effect~     of a continuous meropenem infusion on mortality and emergence of drug resistant pathogens.~     All patients enrolled will receive 1 g of meropenem bolus. After that, subjects will be~     randomized to receive a continuous infusion of study drug 3g/day or a bolus administration of~     the same amount of drugs. The investigators expect a reduction of mortality and emergence of~     extensive or pan drug resistant pathogens from 52 to 40% in the continuous infusion group.~   "
8713|NCT03452826|"~     To assess the effectiveness of a management strategy combining a broad panel respiratory mPCR~     and an algorithm of early antibiotic de-escalation and discontinuation based on both the mPCR~     results and the procalcitonin (intervention) in severe CAP, as compared to a conventional~     strategy (control).~      A multicentre, parallel-group, open-label, randomized controlled trial. The primary~     assessment criterion est the number of antibiotic-free days at 28 days~   "
8731|NCT03452592|"~     This study is conducted to evaluate the efficacy and safety of Alflutinib in locally advanced~     or metastatic non-small cell lung cancer patients harbouring T790M mutation~   "
9566|NCT03441620|"~     In this study, we propose to investigate the effects of dietary achievable doses of~     strawberries on serum LDL-cholesterol (LDL-C) and related lipid profiles, measures of~     glycemia and insulin resistance, and biomarkers of inflammation in a 14 week controlled~     crossover study.~   "
8714|NCT03452813|"~     The TCSD Study will identify disparities in transitions of stroke care and key factors~     associated with effective transitions of care through structured telephone interviews to~     evaluate medication adherence, healthy lifestyle, utilization of rehabilitation interventions~     and medical follow-up 30 days after hospital discharge to home in 2,400 participants across 6~     comprehensive stroke centers (CSC) in Florida. A novel Transitions of Stroke Care Performance~     Index (TOSC PI) correlated with 90-day rehospitalization will be derived and validated.~   "
8715|NCT03452800|"~     Our goal is to determine the representations of addiction among caregivers working in the~     field of mental health. We hypothesize that caregivers, despite their investment in care,~     have a negative social representation of patients suffering from addictive disorders, which~     could be related to a lack of training on the pathology and its social repercussions.~   "
8716|NCT03452787|"~     Obesity is driven by genetic and environmental factors. Among the latter, diet is a most~     important one. The investigators refer to these combinations of genetic and dietary factors~     as 'gene-diet interactions.' Higher consumption of saturated fats (found mostly in foods of~     animal origin) has been associated with higher weight in people who were homozygotes for the~     minor allele at a genetic variant known as APOA2 -265 T>C (rs5082). In the current study, the~     investigators will seek to gain an understanding of the biological mechanisms driving this~     interaction. The investigators will select participants in three cohorts according to this~     genetic factor and conduct a series of molecular analyses (epigenetics, transcriptomics, and~     metabolomics). The analyses will identify epigenetic marks that are associated with saturated~     fat intake exclusively in subjects who carry this genetic factor. Moreover, the investigators~     will examine the association between epigenetic status and genotype at APOA2 and mRNA~     expression of the gene, and concentrations of metabolites in the blood. This study will~     increase the understanding of how genetics and diet act together to promote weight gain, and~     may eventually have implications for dietary recommendations that make use of genetic~     information.~   "
8717|NCT03452774|"~     International registry for cancer patients evaluating the feasibility and clinical utility of~     an Artificial Intelligence-based precision oncology clinical trial matching tool, powered by~     a virtual tumor boards (VTB) program, and its clinical impact on pts with advanced cancer to~     facilitate clinical trial enrollment (CTE), as well as the financial impact, and potential~     outcomes of the intervention.~   "
8718|NCT03452761|"~     Exogenous ketone supplements in the form of beta-hydroxybutyrate can be utilized as an~     alternate energy source (in place of glucose) for all cells except red blood cells. Exogenous~     ketone administration has been shown to be beneficial in terms of reducing oxidative stress,~     improving neuronal energy supplies, and maintaining normal blood glucose levels. The purpose~     of this study is to determine the effects and safety of supplementing with exogenous ketones~     for 6-weeks in healthy college-aged males and females. The results of this proposed study~     will determine whether exogenous ketone supplementation can be useful in promoting better~     body composition, energy levels, and blood cholesterol, glucose, and insulin levels.~   "
8719|NCT03452748|"~     Epiretinal membranes (ERM) are disorders leading to vision loss and metamorphopsia.~     Vitrectomy with membrane peeling has developed to be the gold-standard in treatment of ERM.~     ERM can be well visualized with spectral domain optical coherence tomography (SD-OCT).~      The aim of the study is to examine ERM and internal limiting membranes (ILM) exzised during~     routine macular surgery with fourier transformed infrared spectroscopy (FTIR) and compare~     results to optic coherence tomography (OCT) findings.~   "
8720|NCT03452735|"~     Etiopathogenesis of Chronic inflammatory rheumatisms (CIR) includes genetic, autoimmune and~     environmental factors. Their impact on the quality of life is important, leading to a~     sometimes severe disability. Thus they are likely to affect female fertility through several~     mechanisms, including autoimmune since the association between immunity and fertility has~     already been demonstrated in other autoimmune diseases.~      This study wants to evaluate and compare the birth rate between CIR and control group.~   "
8721|NCT03452722|"~     This study compares the neuroinflammatory response in patients with hypertensive ICH and IVH~     treated with intraventriculary applied rtPA, and the control group. The inflammatory mediator~     concentration is analyzed in local cerebrospinal liquor.~   "
8722|NCT03452709|"~     The principal objective is analyzed whether a selective intervention no pharmacological (use~     of ABPM +/- prescription of physical exercise) for cardiovascular risk factors in patients~     with high cardiovascular risk in primary prevention is associated with a decrease in~     cardiovascular risk measured using the risk Score tables for countries with a low risk. It~     will be independently analized the effectiveness of systematic use of ABPM and the~     prescription of physical exercise.~   "
8723|NCT03452696|"~     Interventional Clinical trial with food supplement, randomized, double-blind, comparative~     between microencapsulated calcium, calcium carbonate salts standardized and calcium citrate,~     in a population of postmenopausal women, lasting 1 month.~   "
8724|NCT03452683|"~     The purpose of this study is to determine the efficacy and feasibility of using a smartphone~     application to monitor symptoms and weight in patients with advanced heart failure.~   "
8725|NCT03452670|"~     The study will examine the use and impact of a meditation app delivered to adult workforce~     populations facing extreme time demands. Enrollees will be randomized to either app or a~     wait-list group, and will be assessed in terms of job and daily functioning, well-being, and~     biomarkers of immune function and stress physiology, and neural structure and function prior~     to randomization and again at multiple time points after participants commence app~     engagement. In order to assess efficacy, we will examine the longitudinal changes in all~     measures in both the mindfulness group, compared to wait-list control group.~   "
8726|NCT03452657|"~     The purpose of this study is to determine the efficacy and safety of intravitreous~     ranibizumab treatment versus sham injections for prevention of high-risk DR.~   "
8727|NCT03452644|"~     A retrospective evaluation of soft tissue tumors that have undergone core needle biopsy with~     US guidance (US-CNB)~   "
8728|NCT03452631|"~     Psoas hematomas are a rare and potentially lethal pathology whose incidence in resuscitation~     is unknown. The pathophysiology of this pathology is not known to date.~   "
8729|NCT03452618|"~     To compensate for insufficiency of diagnostic tools, the present study propose to look for~     the predictive factors of an early fitting by noninvasive ventilation.~   "
8732|NCT03452579|"~     The purpose of this study is to test the effectiveness (how well the drug works), safety and~     tolerability of an investigational drug called nivolumab (also known as BMS-936558) in~     glioblastoma (a malignant tumor, or GBM), when added to bevacizumab.~      Nivolumab is an antibody (a kind of human protein) that is being tested to see if it will~     allow the body's immune system to work against glioblastoma tumors. Opdivo (Nivolumab) is~     currently FDA approved in the United States for melanoma (a type of skin cancer), non-small~     cell lung cancer, renal cell cancer (a type of kidney cancer), Hodgkin's lymphoma but is not~     approved in glioblastoma. Nivolumab may help your immune system detect and attack cancer~     cells.~      Bevacizumab is a drug which works on the blood vessel that supply the tumor and potentially~     can starve the tumor by cutting off the blood supply to these tumors. Bevacizumab is~     commercially available and FDA approved for patients with recurrent glioblastoma.~      This study has two study groups. Arm 1 will receive the study drug Nivolumab 240mg and~     bevacizumab 10 mg (standard dose) every 2 weeks and Arm 2 will receive the study drug~     Nivolumab 240 mg and bevacizumab 3 mg (reduced dose) every 2 weeks. A process will be used to~     assign patients, by chance, to one of the study groups. Neither patients nor doctors can~     choose which group patients are in. This is done by chance because no one knows if one study~     group is better or worse than the other. 90 total patients are expected to participate in~     this study (45 patients in each arm).~      Your total participation in this study from the time you have signed the informed consent to~     your last visit, including follow-up visits, may be more than three years (depending on what~     effect the treatment has on your cancer, and how well you tolerate the treatment).~   "
8733|NCT03452566|"~     Actinic cheilitis is a major potentially carcinogenic disorder of the lower lip and several~     reports of clinical cases with excellent results for the treatment of this lesion that can~     differentiate to squamous cell carcinoma of the lip. However, clinical trials are lacking to~     define the optimal dosage of the drug for a therapeutic modality and to define its true~     efficacy in controlled studies of this pre-malignant labial lesion.~   "
8734|NCT03452553|"~     Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer. This type of~     cancer may be hypervascular. Hypervascular means there is an increased number or~     concentration of blood vessels. These blood vessels get their blood supply from the hepatic~     artery, while the non-tumor liver tissue gets blood supply from the portal vein. Therefore,~     blockage of the hepatic artery to cut off the blood supply to the tumor is possible without~     affecting the normal liver.~      This research protocol will study chemoembolization using radiopaque beads loaded with a~     chemotherapy drug called doxorubicin. Chemoembolization is a procedure in which the blood~     supply to a tumor is blocked after anticancer drugs are given in blood vessels near the~     tumor. In this study, the anticancer drug, doxorubicin, is attached to small beads that are~     injected into an artery that feeds the tumor. The radiopaque beads (RO beads) are visible on~     imagining scans (X-rays) so that the Interventional Radiologist performing the~     chemoembolization procedure can see the location of the beads in the tumor during and after~     the procedure. The visibility of the beads allows the interventional radiologist to confirm~     where the beads loaded with doxorubicin have been delivered in the tumor; this in theory~     could help to improve the efficiency of embolization and plan the next course of treatment.~     In addition to the embolization, the beads elute a sustained dose of doxorubicin locally to~     the tumor site as a second effect.~   "
8735|NCT03452540|"~     The purpose of this randomised, double-blind, placebo-controlled, phase II study is to assess~     the efficacy and safety of orally administered DS102 in patients with acute decompensated~     alcoholic hepatitis~   "
8736|NCT03452527|"~     The purpose of this study is to evaluate the safety and effects of repeated intravitreal~     injections of ICON-1 0.6 mg administered as maintenance therapy or in combination with~     aflibercept in patients with wet macular degeneration.~   "
8737|NCT03452514|"~     To demonstrate that the specificity of the Hummingbird microRNA profile for the diagnosis of~     lung cancer in a cohort of patients who meet current eligibility criteria for lung cancer~     screening in the U.S. is superior to the specificity of LDCT.~   "
8738|NCT03452501|"~     The purpose of this observational study is to assess the safety and effectiveness of~     biosimilar Infliximab in patients with inflammatory bowel disease (IBD) in Saudi Arabia where~     no visits or intervention(s) additional to the daily practice will be performed.~   "
8739|NCT03452488|"~     SARA-INT is a phase 2 interventional study performed in Europe and USA aimed to evaluate the~     clinical benefits, safety and tolerability of the investigational drug BIO101 administered~     orally for a six-month (26 weeks) duration to older patients, community dwelling men and~     women aged ≥65 years, suffering from age-related sarcopenia (including sarcopenic obesity),~     and at risk of mobility disability.~      The double-blind, placebo controlled clinical trial will collect and analyse data on physical~     performance and body composition and will specifically focus on the change of one functional~     measurement, the gait speed measured during the 400MW test plus the change of a highly~     standardised patient reported outcome (PRO), the physical function domain PF-10 at the SF-36~     auto-evaluation questionnaire, in order to estimate the efficacy of BIO101 administered over~     26 weeks, in preventing mobility disability in the target population.~   "
8740|NCT03452475|"~     This open-label randomised controlled clinical trial will compare the safety, tolerability,~     therapeutic efficacy and pharmacokinetics and pharmacodynamics of arterolane-piperaquine,~     arterolane-piperaquine plus mefloquine versus artemether-lumefantrine.in children with~     uncomplicated falciparum malaria in Kilifi, Kenya. This study will also provide an up to date~     insight on the current presence of antimalarial resistance in this site.~      In addition, all children will be treated with a single low dose of primaquine, dosing is age~     based.~      The investigators will recruit 219 patients aged 2 years to 12 years with acute uncomplicated~     falciparum malaria in Kilifi County Hospital.~   "
8741|NCT03452462|"~     The aims are to compare Direct His Bundle Pacing (DHBP) with biventricular pacing (BiV) in~     terms of electrical resynchronization using electrocardiographic imaging (ECGI) and also in~     terms of acute hemodynamical effect using finger plethysmography and conduction velocimetry.~     The study will be a randomized crossover design with acute measurements.~   "
8764|NCT03452163|"~     Performance Assessment of the PMD-200, a Novel Pain Monitor, in Subjects at Neurointensive~     Care Unit.~   "
9567|NCT03441607|"~     Safety & Efficacy of Micronized Dehydrated Human Amnion Chorion Membrane Biologic (mdHACMb)~     (BioXentral®) in Adults With Pain Due to Osteoarthritis of the Knee.~   "
8742|NCT03452449|"~     To date it is unknown how physical activity levels in adults is limited before and after~     lumbar spine surgery and if physical activity level is associated with disability and~     limitations of quality of life. The main objective is to compare physical activity~     preoperatively and 6 and 12 weeks postoperatively in patients undergoing lumbar spine surgery~     with norm data. In addition, the investigators will study the association of changes in~     physical activity, disability and quality of live.~   "
8743|NCT03452436|"~     The primary aim of the study is - in a prospective controlled design - to examine whether~     treatment-induced decreases in testosterone acts as a mechanism of cancer-related cognitive~     impairment (CRCI) in testicular and prostate cancer patients.~      Secondary aims are 1) to explore whether decreases in testosterone interacts with increasing~     age to cause more severe CRCI in older patients, 2) to explore underlying neurophysiological~     (brain morphology) mechanisms of CRCI, and 3) to evaluate selected genetic variants as~     possible moderators of CRCI.~   "
8744|NCT03452423|"~     The aim of this study is to discuss the effect of gait pattern in patients receiving~     arthroscopic cartilage regeneration facilitating procedure (ACRFP) for treatment of~     osteoarthritis of knees.~   "
8745|NCT03452410|"~     Our objective is to allow positive MRI diagnosis of vestibular neuritis by highlighting~     contrast enhancement of the vestibular nerve on the pathological side of the FLAIR sequence~     acquired 1h after intravenous gadolinium injection in patients with typical vestibular~     neuritis. At present, the diagnosis is based on a combination clinical examination /~     video-head impulse test, and no imaging examination allows the diagnosis to be positive.~   "
8746|NCT03452397|"~     The objective of this study is to evaluate the safety and effectiveness of OC-02 Nasal Spray~     as compared to placebo on signs and symptoms of dry eye disease (DED)~   "
8747|NCT03452384|"~     Major depressive disorder (MDD) is a serious psychiatric illness with a high lifetime~     prevalence rate and causes major clinical, social and economic burden to patients and their~     family. Despite more than 40 antidepressants with various mechanisms are available on the~     market, half of patients fail to achieve remission with optimized medication treatment. Due~     to unsatisfactory efficacy, frequent intolerability and poor compliance of~     psychopharmacotherapies, novel and safe alternative therapies are critically in need to~     improve the treatment of depression.~      Traditional Chinese medicine (TCM) theory describes a state of health maintained by a balance~     of energy in the body. If imbalanced, it can be corrected by acupuncture, the insertion of~     fine needles into different parts of the body. Although there are several clinical trials to~     demonstrate the antidepressant effects of acupuncture, its biological and physiological~     mechanisms are still unknown. In addition, clinical depression is frequently accompanied with~     somatic presentations, which are related to autonomic nervous dysfunction. It would be of~     interest to know if acupuncture could regulate autonomic nervous system (ANS) and improve the~     somatic symptoms in depression. The purpose of this study is to assess the effectiveness of~     acupuncture in the treatment of depression and to determine the influence of acupuncture on~     the molecular and ANS systems.~   "
8748|NCT03452371|"~     In a pilot RCT, smokers hospitalized on the general internal medicine or family medicine~     service will be randomized to: 1) enhanced traditional care (ETC), or 2) patient navigation~     (PN). Patients will be assessed at 1 month for self-report of quitting, use of smoking~     cessation medications, and use of counseling in the outpatient setting. Medical charts will~     be reviewed to ascertain if a prescription for smoking cessation medications was sent to the~     participants' pharmacy (primary outcome), if participants received inpatient tobacco~     counseling from the Tobacco Treatment Service (TTS), and whether they had a diagnosis of~     mental health and substance use.~   "
8749|NCT03452358|"~     A retrospective clinical study will be performed evaluating a large number of partial ceramic~     restorations (IPS e-Max press, Ivoclar, Liechtenstein) placed in general practice. Evaluation~     will be based on the well established Hickel criteria (Hickel et al, 2010). Rationale:~     IPS-e-max press has been made available to the market since 2006. Although millions of these~     restorations have been placed worldwide, clinical data are available of less than 200 single~     restorations only, covering observation periods of 2-8 years.(Guess et al, 2009; Etman en~     Woolford, 2010; Gehrt et al, 2012; Esquivel-Upshaw et al, 2012).~      Objective: Study the survival of lithium disilicate restorations during regular check-ups in~     a private dental practice.~   "
8750|NCT03452345|"~     To evaluate the efficacy and safety of MEDITOXIN in subjects with benign masseteric~     hypertrophy compared with placebo~   "
8751|NCT03452332|"~     The goal of this clinical research study is to learn if it is safe to give a special type of~     radiation called stereotactic ablative radiotherapy (SABR) in combination with durvalumab and~     tremelimumab to patients with advanced forms of cervical, vaginal, or vulvar cancer that is~     recurrent (has returned after treatment) and/or metastatic (has spread). Researchers also~     want to learn if this combination can help to control the disease.~      SABR is a type of radiation commonly used to treat various types of cancer with larger doses~     of radiation focused precisely at the tumor.~      This is an investigational study. Durvalumab is FDA approved for the treatment of urothelial~     cancer. Tremelimumab is not FDA approved or commercially available. The use of these drugs in~     combination with SABR is investigational. SABR is delivered using FDA-approved and~     commercially available methods.~      The study doctor can describe how the study drugs and radiation are designed to work.~      Up to 18 patients will enroll in this multi-center study. Up to 9 will take part at MD~     Anderson.~   "
8765|NCT03452150|"~     This is a phase 1 open label multicentre study of D-0316 administered orally in patients with~     advanced NSCLC who have progressed following prior therapy with an EGFR-TKI (Epidermal Growth~     Factor Receptor tyrosine kinase inhibitor agent). This is the first time this drug has ever~     been tested in patients, and so it will help to understand safety, tolerability,~     pharmacokinetics and preliminary anti-tumour activity of ascending doses of D-0316.~   "
8766|NCT03452137|"~     This study will evaluate the efficacy and safety of atezolizumab compared with placebo as~     adjuvant therapy after definitive local therapy in patients with high-risk locally advanced~     squamous cell carcinoma of the head and neck (SCCHN)~   "
8767|NCT03452124|"~     I quit ordinary smoking (IQOS) is proposed as a bridge to smoking cessation. In this study~     the investigators will examine its effects on aortic elasticity, glycocalyx integrity, and~     exhaled carbon monoxide (CO) concentration, both acutely and after 1 month of use.~   "
8768|NCT03452111|"~     The long term objective is to develop a gel to be used as a male contraceptive.~   "
8752|NCT03452319|"~     Thoracoabdominal oesophageal resection for cancer is a procedure with high risks for~     complications, and patients' preoperative status is a crucial factor for outcome. There are~     only a few studies that evaluate the effect of preoperative intervention, including physical~     exercises and breathing exercises, after this type of surgery.~      The aim of the study is therefore to evaluate the effect of a training intervention before~     resection of the oesophagus.~      One hundred patients scheduled for oesophagus resection according to Ivor-Lewis from five~     different hospitals in Sweden will be included. The patients will be randomized to an~     intervention group or a control group. The training intervention starts directly after~     preoperative radiotherapy and chemotherapy are given and lasts until three months~     postoperatively.~      Intervention includes increased physical activity, strength training and respiratory muscle~     training.~      At inclusion and three months after discharge, the patients will undergo tests of physical~     function and lung function. In addition, they will fill in questionnaires concerning level of~     physical function, level of physical activity and quality of life. These questionnaires will~     also be answered one year after surgery.~   "
8753|NCT03452306|"~     Bioequivalence Study of 2 formulation of metformin (Metformin GEROPHARM vers. Glucophage®~     Long Merck )~   "
8754|NCT03452293|"~     The study will evaluate the safety and efficacy of subintimal Supera stenting in complex de~     novo or re-occlusive CTO (TASC C-D) lesions in patients with CLI. This study will be~     performed based on a rigorous sample size calculation, which will allow us to have the~     statistical power to validate our conclusions and therefore establish the generalizability of~     this strategy.~   "
8755|NCT03452280|"~     The JADE wRAP™, a wrist worn cuff to measure blood pressure and its supporting software~     platform is currently at the final alpha prototype stage of development and is not intended~     for sale.~      There are minimal risks with using the JADE wRAP™ device; however, the likelihood of these~     risks has been reduced through design limitations on electrical power delivered to the device~     and of the pressure delivered to the cuff portion. Patients should experience little to no~     discomfort from the inflation of the JADE wRAP™ cuff.~   "
8756|NCT03452267|"~     The insulin sensitizing effects of metformin and pioglitazone in the skeletal muscle remain~     unknown. Our group aims to analyze molecular changes within the skeletal muscle of~     pre-diabetic patients through the use of a clinical trial in humans.~   "
8757|NCT03452254|"~     Stroke is one of the leading causes of serious long-term impairment. According to the~     estimates, 12,500 people suffer a new or recurrent ischemic stroke in Chile annually, which~     shows the magnitude of the problem. Motor impairment of the upper limb (UL) stands out as the~     principal sequel after a CVA (50% of the patients experience it), and the Constraint-Induced~     Movement Therapy (CIMT) is the rehabilitation approach that shows more scientific evidence~     today. Even though patients reach certain recuperation levels through this approach, results~     are still insufficient since 50-80% of the patients continue having upper limb motor~     impairment after completing standard rehabilitation. Because of this, it is pertinent to~     conduct research to explore new rehabilitation strategies to reduce the impairment indexes~     and to provide information for decision making based on evidence.~      Recent studies on functional neuroimaging propose that there is an abnormal balance in the~     motor cortex excitability after stroke - relative under-excitability in the affected~     hemisphere and over-excitability in the unaffected hemisphere (with the consequent inhibitory~     influence on ipsilesional regions) in patient with subacute/chronic stroke and moderate motor~     impairment. This imbalance in the hemispheres function would limit the possibilities of a~     greater recovery. Then, in order to reestablish brain balance, the investigators proposed~     that the early introduction of noninvasive techniques of brain stimulation, such as tDCS, to~     the motor rehabilitation training could promote improvement of upper limb function in~     patients with stroke. However, we lack studies that confirm the benefits of using these~     techniques, define the most appropriate protocols, and determine what patients and under~     which evolving stages would be the best candidates for treatment.~      This study aims to compare the effectiveness of seven days of bi-hemispheric tDCS, both~     active and sham, combined with modified CIMT (mCIMT) in the motor and functional recovery of~     the hemiparetic upper limb in hospitalized patients with subacute unihemispheric stroke at~     Hospital Clínico de la Universidad de Chile and Hospital San José. This comparison responds~     to the hypothesis that patients who receive bi-hemispheric and active tDCS combined with~     mCIMT (experimental group) get at least 30% more recovery of the paretic upper limb compared~     to the control group who receive sham bi-hemispheric tDCS plus mCIMT after a protocol of~     seven days treatment.~   "
8758|NCT03452241|"~     The purpose of this research is to improve the ability of primary medical staffs in screening~     and intervention for alcohol, benzodiazepines, and other illicit drug use.~   "
8759|NCT03452228|"~     The primary objective is to determine the change in Triglyceride (TG) levels following 12~     weeks of repeated Intravenous (IV) doses of evinacumab.~   "
8760|NCT03452215|"~     Randomized controlled trial to investigate the impact of a pregnancy-specific mobile phone~     application on the knowledge of specific pregnancy topics and guidelines.~   "
8761|NCT03452202|"~     The purpose of this study is to determine whether the effect of treatment for acquired speech~     impairment can be enhanced by combining effective behavioral treatment with non-invasive~     brain stimulation. Transcranial direct current stimulation (tDCS), which delivers~     low-intensity current to the scalp, and is a safe and well-tolerated approach that poses a~     non-significant risk to participants. tDCS provides low intensity neural stimulation which~     has been shown to facilitate motor learning in other domains of stroke rehabilitation such as~     arm motor learning but the potential to enhance speech motor learning has not been explored.~     This will be examined with a series of single-case experimental designs.~   "
8762|NCT03452189|"~     The purpose of this study is to determine if multiple doses of vancomycin over the course of~     3 months will perturb the intestinal flora (microbiome) and result in reduced serum~     concentration of the uremic toxin indoxyl sulfate and p-cresyl sulfate. The design of the~     study will permit investigators to assess the variability of serum uremic retention solute~     concentrations with and without antibiotic over a three-month period.~   "
8763|NCT03452176|"~     A novel technology called Scrambler Therapy is a non-invasive pain modifying technique that~     utilizes transcutaneous electrical stimulation of C fibers with the intent of re-organizing~     maladaptive signaling pathways. This neuromodulatory therapy has been investigated for~     treatment of chronic neuropathic pain in several conditions including chemotherapy-induced~     peripheral neuropathy, post-herpetic neuralgia and post-surgical neuropathic pain with~     promising results. Patients report sustained relief after undergoing daily treatment sessions~     for 10 consecutive weekdays. This study is a randomized single blinded, sham-controlled trial~     of patients with Neuromyelitis Optica Spectrum Disorder who have central neuropathic pain~     using Scrambler Therapy added to standardized empiric medications using patient reported~     outcomes to determine if Scrambler Therapy is a feasible and effective add-on treatment of~     chronic neuropathic pain.~      This trial will recruit twenty-two adult patients diagnosed with NMOSD who have chronic~     neuropathic pain despite empiric treatment with an anti-epileptic, antidepressant, opioid~     and/or an NSAID medication. Patients will be randomized 1:1 to undergo Scrambler Therapy or~     blinded sham daily for 10 days. The primary outcomes will be acceptability and feasibility.~     The secondary outcome will be efficacy measured as a change in pain scores of more than two~     points recorded daily by the patient using an 11-point visual analog scale; quality of life~     (QoL), neurologic function, anxiety, depression, sleep disturbance and pain will also be~     evaluated at baseline, at the end of therapy, and at 4 & 8 weeks following completion of~     treatment. Investigators hypothesize that Scrambler Therapy will be an acceptable, feasible~     and efficacious intervention that significantly reduces pain in patients with neuromyelitis~     optica spectrum disorder.~   "
8769|NCT03452098|"~     A case-series review was performed on five collegiate athletes with osteochondral lesions of~     the knee at California State University, Northridge (CSUN). All subjects received surgical~     intervention to treat the defect. The surgeries performed were either an Osteoarticular~     Transfer System (OATS) procedure and/or a Microfracturing procedure. Subjects were treated~     post-operatively by the CSUN team physical therapist and/or athletic trainers at CSUN. This~     paper seeks to provide information about osteochondral defects of the knee, the surgical~     interventions, and a protocol for post-operative treatment and rehabilitation of such~     injuries.~   "
8770|NCT03452085|"~     In diabetes Type II the xerostomia is a quite frequent symptom. In evaluating the activity of~     an artificial saliva spray compared to a water gel in patients with Diabetes Type II patients~     had to follow a three day treatment with each product. Whereas after the first treatment~     period the two groups had to follow a wash out period of three days before the second~     treatment period could begin.~      The artificial saliva spray reduced the xerostomia and the inflammation or the oral tissue.~   "
8771|NCT03452072|"~     The use of topical beta-blockers, such as 0.25% timolol, in promoting wound healing is~     currently emerging in the academic literature. The investigators will enroll 114 patients who~     have their skin cancer surgically removed resulting in open surgical wounds less or equal to~     1.5 cm. The objective of this randomized safety study is to determine the safety and efficacy~     of 0.25% timolol in promoting wound healing in open surgical wounds less or equal to 1.5 cm.~   "
8772|NCT03452059|"~     Evaluation of the effectiveness and safety of the lower extremity exoskeleton rehabilitation~     training robot~   "
8773|NCT03452046|"~     Collapsibility (CI-IVC), distensibility (dIVC) and delta (ΔIVC) indices, which are dynamic~     measures of inferior vena cava (IVC) diameter, are used to assess the intravascular volume~     status in critically ill patients. Positive pressure support (PS) has been shown to induce~     IVC diameter distention by increasing intrathoracic pressure, and high positive expiratory~     pressure (PEEP) decreases the CI-IVC percentage (4). During Triggered positive pressure~     support it is necessary to clarify which IVC index is valid for measuring the volume~     status.it is aimed to compare the IVC indexes (CI-IVC, DIVC, ΔIVC), positive rate of change~     with pressure, correlation with central venous pressure and accurate prediction of volume~     status in patients with different positive pressure support.~   "
8774|NCT03452033|"~     The study will evaluate the safety, tolerability, and preliminary efficacy of three~     concentrations of H-1337 and vehicle administered twice daily in a parallel group,~     double-masked design for 28 days of dosing in patients with elevated intraocular pressure~     (IOP).~   "
8775|NCT03452020|"~     Patients who present to the Emergency Department will be evaluated for eligibility to the~     study. Those meeting all the inclusion criteria and none of the exclusion criteria will~     undergo an informed consent process and will sign a written consent. Within each age group~     both afebrile and febrile patients will be represented.~      The patients will be divided into 3 study groups by age:~      Group 1: up to 1 year Group 2: 1 to 5 years Group 3: older than 5 years~      The following temperature measurements will be taken:~        1. Three temperature measurements using the Tyto thermometer~        2. Temperature measurement using the standard of care~        3. Three temperature measurements using the predicate device~   "
8776|NCT03452007|"~     The investigators propose to determine the electrode configurations that promote functional~     gains in the storage and voiding phases of lower urinary tract function as a result of~     activation of spinal circuits with spinal cord epidural stimulation in humans with spinal~     cord injury. The innovative approach and novel application of the Medtronic Specify 5-6-5~     (16-electrode array) epidural device will allow the investigators to determine, with this~     early feasibility study, specific parameters of spinal cord epidural stimulation and~     approaches for bladder training needed for lower urinary tract function which will lay the~     groundwork for expedient translation of this promising technology to larger numbers of~     individuals with spinal cord injury who currently have limited treatment options. The current~     proposed study will increase the understanding of human lumbosacral spinal networks and guide~     the use of innovative therapeutic strategies that would be immediately available to not only~     improve the motor output during standing and walking but also ameliorate bladder dysfunction~     and thus improve quality of life in individuals after spinal cord injury.~   "
8777|NCT03451994|"~     The purpose of this secondary analysis is to identify breath signatures associated with~     idiopathic malodor conditions.~   "
8778|NCT03451981|"~     Peri-implantitis are important disease entities as a result of their high prevalence and the~     lack of a standard mode of therapy.~      Based on the available data, the non-surgical therapy of peri-implantitis doesn't seem to be~     effective in disease resolution. Surgical access to peri-implantitis lesions facilitates the~     removal of all granulation tissue from the defect area as well as a thorough debridement and~     decontamination of exposed implant surfaces.~      Numerous approaches have been used for implant surface decontamination during peri-implant~     surgery, including mechanical, chemical and laser treatments.~   "
8779|NCT03451968|"~     Introduction Sarcopenia is defined as progressive generalized loss of skeletal muscle mass,~     strength and function. Sarcopenia due to lack of physical activity is a known phenomenon and~     is usually observed as a normal part of aging or in certain diseases and pathogenic~     processes. Major associated factors causing development of sarcopenia may be summarized as~     interactions of environmental and hormonal factors, underlying diseases, activation of~     inflammatory pathways, mitochondrial dysfunction, reduced satellite cell numbers, and loss of~     neuromuscular junctions.~      Intensive care acquired weakness (ICU-AW) known formerly as critical illness polyneuropathy,~     is a diagnosis that becomes more common as survival rates from long ICU hospitalization are~     more prevalent. It is characterized by a primary axonal degeneration, without demyelination,~     that typically affects motor nerves more than sensory nerves.~      ICU-AW affects the limbs (particularly the lower extremities) in a symmetric pattern.~     Weakness is most notable in proximal neuromuscular areas (e.g., the shoulders and hip~     girdle). In addition, involvement of the respiratory muscles can occur and can impede weaning~     from mechanical ventilation.~      The pathophysiological mechanisms of ICU-acquired weakness are believed to be multifactorial.~     Some suspected factors include dysfunctional microcirculation and hyperglycemia. It has been~     shown that tight glucose control in ICU patients reduces the risk for ICU-AW (although it has~     been associated with other adverse events). Sodium channels channelopathy is also a~     researched cause for ICU-AW. Muscle loss in the ICU are usually related to bedridden~     condition and lack of mobility, increase in ubiquitination and inadequate protein~     administration associated with large negative nitrogen balance. In addition mechanical~     ventilation contributes greatly to this problem. This has been particularly relevant in post~     trauma/surgical long stayer patients.~      In the past years great progress was made in the investigation of protein balance, breakdown~     and synthesis using stable isotope tracers in various medical conditions. In a research~     performed in PICU (1-5) and ICU (6, 7) regarding the measurement of plasma amino acid during~     critical illness, stable phenylalanine, tyrosine leucine, arginine and citrulline isotope~     were used intravenously without any safety issue problem. Another study was performed on~     adults suffering from COPD with matched healthy adults, using stable isotopes of~     phenylalanine, tyrosine leucine, isoleucine and valine (8). During the study the isotopes~     were given parenterally as well as enterally. The study showed significant change in~     splanchnic extraction of various amino acids and higher turnover of BCAA in COPD patients.~     Using the theory that supplemental milk can compensate for the elevated turnover of BCAA in~     COPD patients, using the isotope analysis demonstrated that this theory was proven wrong and~     the conclusion was that alterations are present in BCAA metabolism despite normal plasma~     levels in normal weight COPD. Further research is needed to find a way to compensate for it.~     These studies and other recent studies (9-19) show us the safety regarding the use of stable~     isotope tracers whether IV or PO, while giving us the opportunity to assess the metabolism of~     amino acid in all sorts of pathological states.~      Hypothesis & Aim of the study We think that based on current literature, there are important~     differences between critically ill patients and healthy population in the amino acid profile~     and distribution in the body as well as synthesis and breakdown.~      The aim of the study is to measure these differences in long ICU stayers (above 7 days)~     admitted in the ICU after surgical/trauma injury, and to try and help aiming future treatment~     and research in this field.~   "
8780|NCT03451955|"~     Disruption of the blood brain barrier (BBB) is associated with inflammatory conditions of the~     central nervous system (CNS). This clinical trial aims to investigate whether following a~     gluten-free diet (GFD) for six months can contribute to normalizing BBB permeability in~     patients with newly diagnosed clinically isolated syndrome (CIS) and multiple sclerosis (MS).~     Furthermore, the study seeks to identify possible effects of a GFD on markers of systemic as~     well as CNS inflammation. Lastly, gut permeability is measured in order to examine whether~     there are any correlations between the permeability of the gut and the BBB as well as the~     inflammatory state in the intestine and CNS. From a patient's view, potential positive~     effects of a GFD will be manifested through an alleviation of symptoms, improved quality of~     life and reduced risk of CIS progressing to MS. Evaluating a possible role of gluten in MS~     pathogenesis can contribute to directing future research and optimizing treatment protocols.~   "
8781|NCT03451942|"~     Evaluate survival benefit of surgical treatment after FLOT regimen conversion therapy of~     Her-2 Negative and single site metastasis adenocarcinoma of the stomach / gastroesophageal~     compared with chemotherapy, use relevant biomarkers to evaluate the efficacy of chemotherapy~     and seek for patients with Her-2 negative and metastatic adenocarcinoma of the stomach /~     gastroesophageal surviving benefit from surgical treatment after the FLOT regimen conversion~     therapy.~   "
8786|NCT03451877|"~     The investigators aimed to investigate TGFB1 and LAMA1 gene polymorphisms in children with~     high myopia in order to determine the genetic basis of large myopic shifts causing severe~     visual impairment and complications.~      Seventy-four children with high myopia (≥6 diopters [D]; study group) and 77 emmetropic~     children (±0.5D; control group) were included. Genetic and polymorphism analyses were~     performed in the Medical Genetics Laboratory using DNA purified from the patients' blood~     samples.~   "
8787|NCT03451864|"~     Eighty-eight pregnant women and their newborns were enrolled in a cross-sectional study.~     Maternal serum 25-OHD was measured by ELISA~   "
8788|NCT03451851|"~     The purpose of this study is to evaluate the efficacy and safety of guselkumab in pediatric~     participants aged greater than or equal to 6 through less than 18 years with chronic plaque~     psoriasis.~   "
8789|NCT03451838|"~     Fetal macrosomia defined as birth weight above 90th centile ,macrosomia occurs in 42-62%of~     pregnancy complicated by type 1 diabetes mellitus ,in 30-56% of pregnancy complicated by type~     2 diabetes mellitus .~      -The delivery of macrosomic infant has potentially severe consequence for both the newborn~     and mother .Increased birth weight increase the risk in the fetus of shoulder dystocia and~     premature brachial plexus injury ,and those infant weighing above 4500g are at increased risk~     for neonatal morbidity ,including the need for assisted ventilation and meconium aspiration~     .Maternal complication result from operative delivery and include postpartum hemorrhage~     ,third or fourth degree laceration and postpartum infection .~   "
8790|NCT03451825|"~     This is a multi-center, open-label, international study to evaluate the dose, safety and~     tolerability, antitumor activity, pharmacokinetic and pharmacodynamics of avelumab in~     pediatric subjects 0 to less than 18 years of age with refractory or relapsed malignant solid~     tumors (including central nervous system tumors) and lymphoma for which no standard therapy~     is available or for which the subject is not eligible for the existing therapy.~   "
8791|NCT03451812|"~     Primary objective:~      To correlate the blood/urine metabolomic biomarkers with PET/MR imaging.~      Secondary objectives:~        1. To evaluate the sensitivity and specificity of the PET/MR in diagnosis of prostate~          cancer.~        2. To examine the diagnostic performance among subgroups of defined high-risk and low-risk~          subjects.~        3. To interrogate the metabolomic alterations with the molecular PET/MR to develop workable~          panel biomarkers.~   "
8792|NCT03451799|"~     Enrolled subjects will be placed on a 16-week ketogenic diet (subject specific as prescribed~     by RD) while receiving standard of care cancer treatment (Radiation + Temozolomide). Study~     dietitians will create personalized meal plans for each patient with the goal of achieving~     and maintaining protocol defined metabolic ketosis. Subjects will be monitored for safety,~     nutrition, quality of life, and standard of care tumor assessments over the course of the~     study.~   "
8793|NCT03451773|"~     Background:~      Pancreas cancer ranks 4th in all cancer-related deaths in the U.S. Gemcitabine is a standard~     treatment for it. M7824 blocks a pathway that prevents the immune system from effectively~     fighting cancer. The two drugs together might help people with pancreas cancer.~      Objective:~      To test if giving M7824 together with gemcitabine is safe and causes tumors to shrink.~      Eligibility:~      People ages 18 and older with pancreatic cancer already treated with standard therapies~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Scans in a machine that takes pictures of the body~      Blood, urine, and heart tests~      Some participants may have a tumor sample removed.~      Participants will get M7824 by IV once every 2 weeks. They will continue until their disease~     gets worse or they have unacceptable side effects. In addition they will get~      Participants will get gemcitabine by IV once weekly for 7 weeks. Then they will get it as~     follows for up to 6 months: Skip 1 week, get the drug once a week for 3 weeks, skip 1 week.~      Before treatment on the first day of each cycle, participants will repeat screening tests.~     They will also have:~      Optional tumor biopsies before and after 3 cycles of therapy~      Questions about their well-being and function~      Genetic testing of tissue and blood samples~      Participants will have a follow-up visit 4 5 weeks after they stop therapy. This includes a~     physical exam, blood and urine tests, and maybe a scan. If their disease does not get worse,~     they will be invited for scans every 12 weeks.~   "
8794|NCT03451760|"~     This is designed as a randomized, double-blind, placebo-controlled clinical trial with a 12~     week intervention period. Seventy participants with a diagnosis of AD, vascular, and mixed~     dementia with at least 3 behavioral symptoms present from the Neuropsychiatric Inventory~     Questionnaires (NPI-Q) will be randomized to the Feru-guard (ferulic acid and Angelica~     archangelica) or placebo group. Participants will be screened first by a telephone interview~     or briefly in-clinic and then will be scheduled for an in-clinic screen to establish study~     eligibility prior to the baseline assessment visit. Clinical and biological outcome measures~     will occur at baseline and 12 weeks.~   "
8795|NCT03451747|"~     The incidence of CVD-related deaths is generally higher in women than men. Postmenopausal~     changes in estrogen/androgen ratio that induce a relative androgen excess have been proposed~     as important factors in the higher prevalence of hypertension. Therefore, the investigators~     hypothesize that testosterone has potential role between hypertension and target organ damage~     in postmenopausal hypertensive women. And the objective is to evaluate the effects of~     testosterone between hypertension and target organ damage in postmenopausal hypertensive~     women.~   "
8796|NCT03451734|"~     The aim of this project is to establish and improve the Chinese schizophrenia clinical~     information database and biobank patients, by evaluating the related genetic gene,~     psychopathology, neuropsychology, brain physiology and biochemistry the image indexes, and~     found 6 kinds of commonly used antipsychotics (olanzapine, risperidone, aripiprazole,~     ziprasidone, amisulpride, haloperidol) treatment response biomarkers and biomarker selection~     which can predict antipsychotic efficacy and adverse reactions of schizophrenia, establish~     individual clinical disease commonly used antipsychotic drug treatment to optimal treatment~     for the disease, and further testing, validation and evaluation of biomarkers in clinical~     independent samples. At the same time, the investigator focus on solving the problem of~     antipsychotic induced metabolic syndrome.~   "
8797|NCT03451721|"~     To observe the safety and effectiveness of ImageReady™ MR conditional defibrillation system~     in a Chinese population.~   "
35824|NCT03097692|"~     An association between white blood cell count (WBC), neutrophil-lymphocyte ratio , and~     inflammatory process is well known . Ischemic preconditioning reduces the inflammation~   "
8798|NCT03451708|"~     Hemispatial neglect is a disorder where the patient has difficulty attending to objects and~     information in the left side of space, which occurs following strokes to the right side of~     the brain. This project is designed to help us understand how optokinetic stimulation treats~     the symptoms of hemispatial neglect.~   "
8799|NCT03451695|"~     The incidence of chronic post-surgical pain (CPSP) after caesarean section (CS) is reported~     to be as high as 18%, reflecting it to be a significant clinical problem. Studies related to~     prevention of progression of acute post-CS pain to its chronicity are sparse. Current~     guidelines on post-CS analgesia recommend the use of intrathecal (IT) opioids to spinal~     anaesthesia for improved post-CS pain relief. Despite its frequent use, studies related to~     the IT morphine use and its association with post-CS chronic pain are lacking.~      A recent prospective observation study revealed a significant reduction in persistent pain~     after CS when IT morphine was used as an adjuvant to spinal anaesthesia. However, there is no~     any randomized controlled trial (RCT) that has explored this association to date. We~     hypothesized that spinal morphine would reduce the incidence of persistent pain after CS.~   "
8800|NCT03451682|"~     Cryopreservation is the storage of biological material at subzero temperatures at which~     biochemical processes of cell metabolism and the biochemical reactions that lead to cell~     death are slowed, interrupted or stopped.Many investigators have focused on the use of~     antioxidants in the freezing media to reduce the negative effects of reactive oxygen~     species(ROS) on spermatozoa and in this context addition of vitamin E to cryoprotective~     medium enhanced the post-thaw sperm motility and preserved sperm DNA integrity , superoxide~     dismutase (SOD) and catalase (CAT) were added to boar spermatozoa freezing media and they not~     only increased sperm motility and viability but also decreased post-thaw ROS generation which~     led to improvement in results of in vitro fertilizing with thawed spermatozoa.However, the~     impact of in vitro addition of proanthocyanidins to human semen before cryopreservation on~     post-thawing semen parameters, DFI has not been studied yet. The research question evaluated~     in the current study was whether semen samples of infertile men supplemented or not with~     procyanidine before cryopreservation, differ in post-thawing semen parameters and sperm DNA~     fragmentation index (DFI).~   "
8801|NCT03451669|"~     There have been reports in the past of using thermal cameras to demonstrate flow in the~     tubing as a surrogate of proper shunt function. This was shown to have almost 90% accuracy at~     determining proper functioning but required expensive equipment that was not universally~     available. There is now smart phone based thermal camera technology (Flir One:~     http://www.flir.com/flirone/) that could make this technique widely available for health care~     use. The goal of the study is to determine if this device can demonstrate flow in the distal~     tubing of a VP shunt.~   "
8802|NCT03451656|"~     The project aims to use epidemiological tools to understand the transmission and evolution of~     influenza viruses at an individual and population level within a small-scale city (Basel)~     through a combination of experimental, clinical, and mathematical advances. Investigators aim~     to quantitatively characterize the viral transmission using novel molecular-epidemiological~     tools based on whole genome sequencing.~   "
8803|NCT03451643|"~     Patients with Stage IV obstructing colorectal cancer and unresectable liver metastses, with~     general and local conditions not a risk for coliorectal resection, will be randomized to have~     either endoscopic stenting or colorectal resection~   "
8804|NCT03451630|"~     Multiple chronic conditions (MCC) are widely recognized as the U.S. public health challenge~     of the 21st century. These physical and behavioral health conditions take a large toll on~     those suffering from the diseases, including many who are publicly insured, as well as~     caregivers and society. While evidence-based integrated care models can improve outcomes for~     individuals with MCC, such models have not yet been widely implemented. Insurance~     providers/payers have innovative system features that can be used to deploy these models;~     however, the investigators do not yet know which of these features can best help to improve~     outcomes for individuals with MCC in general or high-need subgroups in particular. As a~     result, patients lack information to make important decisions about their health and health~     care, and system-level decision makers face ongoing challenges in effectively and efficiently~     supporting those with MCC.~      This real-world study will provide useful information about available options for supporting~     individuals with MCC. Building on existing integrated care efforts, the investigators will~     enroll 1,662 adults with MCC at risk for repeated hospitalizations and assess the impact of~     three payer-led options (High-Touch, High-Tech, Usual Care) on patient-centered outcomes,~     namely patient activation in health care, health status, and subsequent re-hospitalization.~     The investigators will also determine which option works best for whom under what~     circumstances by gathering information directly from individuals with MCC through self-report~     questionnaires, health care use data, and interviews.~   "
8805|NCT03451617|"~     To evaluate and compare the performance of two stent delivery systems for percutaneous~     coronary intervention with everolimus-eluting stent.~   "
8806|NCT03451604|"~     The aim of the preoperative assessment clinic (PAC) is to ensure optimal anaesthesia, reduce~     the morbidity associated with surgery, to increase the quality and decrease the cost of~     perioperative care 1. In addition, the PAC is an appropriate time to educate the patient on~     anaesthesia, perioperative care, and pain treatments, to reduce anxiety, to develop care~     plans, and to obtain informed consent. Moreover, a strong correlation exists between the time~     spent at the PAC and patient satisfaction2,3.~      A high variability of preoperative assessment clinic (PAC) times is a reason for waiting time~     for patient. A better match between the reserved PAC time and the real consultation time~     could improved efficiency in consultation theatre. The PAC time depends on various~     parameters. On average the preoperative assessment of patients with a higher American Society~     Anesthesiologists' (ASA) class requires more time 4. In other monocentric study, the mean~     (SD) procedure time was 13 (6) min for the physician. It was significantly longer for~     patients with a higher ASA class : 10 min for ASA I, 14 min for ASA II, 17 min for ASA III~     and 21 min for ASA IV patients. In this monocentric study, every patient had a nurse~     consultation before PAC by the anesthesiologist.~      The primary endpoint of this study was to assess the time involved in preoperative assessment~     clinic included the time during patient's health status has to be assessed (this encompasses~     a medical history and physical examination) and the time during the patient education on~     anaesthesia, perioperative care and pain treatments, to reduce anxiety, to develop care plans~     and to obtain informed consent.~   "
8807|NCT03451591|"~     About 35,000 people each year in the UK have a type of stroke, called 'lacunar' or 'small~     vessel' stroke, which is different to other common types of stroke and for which there is no~     proven treatment. It is thought that small vessel stroke is caused by damage to the lining of~     the tiny blood vessels deep inside the brain that stops them functioning normally. This not~     only causes stroke but, perhaps more importantly, causes problems with thinking and walking,~     possibly causing up to 45% of all dementias either on its own, or mixed with Alzheimer's~     disease (about 350,000 patients in the UK). Some drugs that are commonly used in other blood~     vessel diseases may help improve small vessel function and prevent worsening of brain damage.~     One drug (cilostazol) has been tested in patients with stroke in the Asia Pacific countries~     but not on dementia; the other drug (isosorbide mononitrate) is widely used in the UK for~     heart disease but not stroke. The investigators want to set up a clinical trial to test if~     the study methods are practical so that patients and trial centres can follow the procedures,~     and to confirm how many patients have more stroke-like symptoms or experience worsening of~     their thinking skills. This information is needed to be sure that a very large clinical trial~     to find out if these drugs can prevent worsening of small vessel disease will be possible.~   "
8808|NCT03451578|"~     The purpose of this study is gain a better understanding of a molecule called alpha~     melanocyte stimulating hormone (alpha MSH) and its potential role in your retinal disease.~     Alpha MSH has been shown to have an important role in the regulation of ocular immunity in~     animal models of inflammatory retinal diseases and retinal dystrophies, and there may be a~     protective effect of alpha MSH. By studying the levels of alpha MSH in your eye we may better~     understand its role in advanced dry macular degeneration. By studying the levels of this~     molecule we hope to better understand if it may be a good target for future treatment.~   "
8809|NCT03451565|"~     This study aims at describing the systemic arterial hypotension secondary to intraoperative~     beach chair positioning. This is a non-interventional prospective study.~      The primary endpoint will be the intraoperative systemic arterial pressure measured at the~     arm.~      The secondary endpoints will include postoperative mortality, intensive care admission, post~     anesthesia care unit length of stay,~   "
8810|NCT03451552|"~     Some people living with health problems require extra support to properly manage their~     conditions, as family doctors are only able to spend limited time in the office with these~     patients. There are many resources and programs in the community that can provide the~     necessary time and support for these patients, yet many patients are unaware that such~     resources exist. Patient navigators have been shown to be useful in helping patients with~     certain conditions (such as cancer) to get to the resources they need, especially when they~     have social challenges that make it difficult for them to reach these programs (for example,~     language or transportation barriers, poverty, or poor social support). This study will look~     at how helpful Navigators are to link patients at family doctors' offices to community~     resources. To do this, family doctors' offices in Ottawa and Sudbury will be recruited. All~     offices will receive training on directing patients to CRs and will be assigned a patient~     navigator to support patients access CRs. Half of the patients referred to CRs by their~     providers will have access to the navigator (intervention) assigned to the practice. This~     study will assess whether access to a navigator increases patients' access to community~     health and social services compared to usual standard of care. In addition, the study aims to~     understand whether English and French speaking individuals are as likely to benefit from a~     navigator in accessing community resources in the language of their choice.~   "
8811|NCT03451539|"~     Numerous studies dealt with the hospital doctors' work but little is known about the work of~     ICU doctors, especially concerning the medical time spent outside the Intensive Care Unit~     (ICU) which is a significant workload that has never been evaluated to date. The main~     objective of our study was to evaluate the time spent by ICU doctors outside the unit, for~     the management of their patients during the IHT and for the care of patients in other~     departments. Secondary objectives were to describe the organization and distribution of~     medical time outside the intensive care unit.~      In this observational study, which took place during 5 years, from January 2012 to December~     2016 in the medical ICU of the Nouvel Hôpital Civil at the University Hospitals of~     Strasbourg, every day after the morning medical staff, the anonymized information were~     collected in a register.~   "
8812|NCT03451526|"~     The trial was designed to compare the effectiveness of radical resections of lung cancer plus~     adjuvant chemotherapies and perioperative chemotherapies in the patients with N2 non-small~     cell lung cancer~   "
8813|NCT03451513|"~     The purpose of this study is to better investigate the efficacy of the PRIDE Body Project in~     respect to preventing eating disorders in sexual minority men. In this randomized controlled~     trial, participants will be enrolled in one of two arms: 1) the PRIDE Body Project~     intervention or 2) Media Advocacy, a time and attention-matched intervention. This study will~     recruit participants who are between the ages of 18 and 30, identify as men, are gay,~     bisexual, or experience sexual attraction to men, and who express body image concerns for the~     San Diego area.~   "
8814|NCT03451500|"~     From 3 large patient databases, patients diagnosed with AMD who have never taken~     levodopa(L-DOPA) containing medications have a mean age of diagnosis at 71 years.~      Patients who have been treated with L-DOPA containing medications have a mean age of~     diagnosis of AMD at 79 years. L-DOPA binds to GPR143 in the retinal pigment epithelium, and~     releases PEDF, which protects the retina and downregulates VEGF, which is the cause of~     neovascularization.~      The Investigators will evaluate the safety and tolerability of carbidopa-levodopa in patients~     with Neovascular AMD, and measure the effects on visual acuity and retinal abnormalities due~     to wet (neovascular) AMD. The Investigators will evaluate the safety and tolerability of~     carbidopa-levodopa in patients with Dry AMD and Geographic Atrophy, and measure the effects~     on visual acuity, area of geographic atrophy and other retinal abnormalities due to dry~     AMD.~   "
8815|NCT03451487|"~     To investigate and compare the possible response of Panadol® and SafeTynadol® formulations in~     healthy volunteers.~   "
8816|NCT03451474|"~     The primary objective of this study is to evaluate the safety and efficacy of nerve transfer~     surgery for restoring hand function as a therapy for patients with cervical spinal cord~     injury.~   "
11710|NCT03413540|"~     This study evaluates the longitudinal, dose-dependent effects of jumping on bone health in~     young women. The women will be divided into 9 groups of varying jump height and repetitions,~     with a tenth group serving as control.~   "
8817|NCT03451461|"~     Invasive mechanical ventilation (IMV) is a life support treatment for patients with acute~     respiratory failure. The IMV can generate adverse effects that may cause alterations in other~     organs besides the lung, creating an important problem during ICU stay, hospital stay and~     years after discharge. These consequences on morbidity and mortality have significant~     economic and social weight. In the United States the IMV represents 2.7 episodes per 1000~     habitants, with an estimated cost of $27,000 million, representing 12% of all hospital~     expenses. The overall mortality in patients with IMV is 30-35%, increasing with age.~     Therefore, patients receiving IMV are a high-risk population and with higher costs.~      A poor interaction between patient and ventilator during IMV can develop asynchronies. The~     asynchronies may present in 25% of patients. The majority of studies in ICU patients are~     limited to a evaluation of short periods of time. Asynchronies identification needs the~     application of respiratory physiology knowledge and the interpretation of respiratory signals~     from the ventilator waves. This allows identifying in an easy way different situations of~     fight, but it also difficult the identification of situation where asynchronies are less~     obvious, doing that them remain underdiagnosed. Moreover, asynchronies can be only evaluated~     during a brief period of time, and it's difficult to know their incidence during all the IMV~     period and to make adjustments to improve them.~      In our centre, it has been developed a continuous monitoring system during IMV which~     integrates, in real-time, all the information derived from digital monitors and ventilators.~     It allows a continuous and automatic detection of different events (through an intelligent~     alarm system) and quantification of asynchronies. It was demonstrated that asynchronies are~     frequent, that it can be present from the beginning of IMV, that it increase in severe~     patients under deep sedation and it can increase ICU and hospital mortality.~      The investigators can study different factors that can influence over asynchronies~     development or can improve them.~   "
8818|NCT03451448|"~     This study will assess the use of position emission tomography/magnetic resonance imaging~     (PET/MRI) using ultra-small-superparamagnetic particles of iron oxide (USPIO) as a contrast~     agent in patients with coronary artery disease.~   "
8819|NCT03451435|"~     Pulp re-vascularization/regeneration is a procedure performed to allow pulpal stem cells to~     survive and/or differentiate to allow immature tooth root structures to grow to full~     maturity. Currently, the procedure includes disinfection of the necrotic root canal space and~     induction of bleeding to potentiate pulpal stem cell differentiation to allow root growth on~     an immature root. A number of studies conducted previously demonstrate that N-acetyl cysteine~     (NAC) potentiates differentiation of pulpal stem/stromal cells and protects pulpal cells from~     apoptosis. 14-18 human subjects will be recruited forming two groups where pulp~     re-vascularization/regeneration procedures will be performed with or without the use of NAC~     treatment prior to induction of bleeding. Recall follow-up appointments will be done at 6~     months and 1 year post treatment with subsequent yearly appointments until full root growth~     has been achieved.~   "
8820|NCT03451422|"~     To evaluate the safety and tolerability of subcutaneous (SC) dose administrations of AMG 592~     in subjects with systemic lupus erythematosus (SLE)~   "
8821|NCT03451409|"~     The Research Domain Criteria (RDoC) approach seeks to address the neurobiological mechanisms~     of sensory symptoms in patients with obsessive-compulsive disorder (OCD) by investigating~     dimensional components of behavior that more closely align with brain circuitry. This project~     focuses on the dimensional symptom of sensory phenomena (SP), which are uncomfortable or~     aversive sensory experiences that drive repetitive behaviors in OCD, including not just~     right sensations, physical urges, and sensations of disgust. SP are very prevalent,~     occurring in 60-80% of OCD patients, and experienced as highly distressing. Unfortunately, SP~     are not well addressed by standard treatment approaches, which may be in part because their~     neurobiological mechanisms are not well understood.~      This project builds on our preliminary data to (1) investigate the neural mechanisms of SP in~     large OCD cohort showing the full range of SP severity and (2) probe for familial risk~     markers in unaffected siblings of patients. For Aim 1, SP will be measured in 100 OCD~     patients using the Sensory Phenomena Scale. Diffusion and fMRI data will be acquired during~     rest and fMRI tasks. In order to identify familial risk markers, Aim 2 will compare sensory~     phenomena and neural circuitry between OCD probands, 50 unaffected biological siblings of OCD~     patients, and 50 unrelated healthy controls without a family history of Axis 1 disorders.~   "
8822|NCT03451396|"~     To determine whether a fall in tear osmolarity precedes improvement in symptoms and signs of~     dry eye in dry eye patients treated topically with 5% lifitegrast drops for 3 months.~   "
8823|NCT03451383|"~     The goal of this study is to evaluate the impact of systemic therapy on cognition in older~     breast cancer patients, explore which domains are most affected, measure associations between~     cognitive decline and QOL, and describe how APOE and COMT polymorphisms, inflammatory~     biomarkers and physical activity moderate cognitive outcomes. This study is being done~     nationally, with recruiting sites at Georgetown University, Montgomery General Hospital,~     Virginia Cancer Specialists, Memorial Sloan-Kettering, Moffitt Cancer Center, City of Hope~     National Medical Center, Hackensack University Medical Center, Indiana University and~     University of California, Los Angeles.~   "
8824|NCT03451370|"~     -  Oxaliplatin-based doublets plus bevacizumab are standard first-line therapy options for~          patients (pts) with metastatic colorectal cancer (mCRC). Slight adjustments in~          chemo-dosage are commonly applied in routinely practice to elderly pts, but those~          modified schedules have never been standardized~        -  The addition of oxaliplatin versus no oxaliplatin to treatment with 5-fluorouracil in~          older and frail untreated pts with mCRC resulted in a non-statistically significant~          trend toward improvement in Progression Free Survival (PFS) and a lack of benefit in~          Overall Survival (OS)~        -  In elderly pts deemed unfit for an upfront combined chemotherapy a fluoropyrimide-based~          monotherapy plus bevacizumab is considered a reasonable first-line treatment~        -  Clinical definition of elderly (over 70 years old) pts with CRC that may deserve a more~          or less intensive combination therapy is still debated. The cut-off of 75 years old~          combined with ECOG PS assessment is a reasonable approach for clearly defining~          candidates to different approaches~        -  Several geriatric screening tools have been used to identify pts with a geriatric~          profile potentially predicting for overall survival and risk of toxicity. The G8~          screening tool has been already validated in pts with cancer showing the strongest~          prognostic value for OS; the CRASH score is able to stratify pts according an estimated~          risk of treatment-related toxicities~      On the basis of these considerations, we designed the present observational study of~     first-line therapy with bevacizumab in combination with capecitabine and oxaliplatin in~     previously untreated elderly pts affected by unresectable mCRC in order to evaluate its~     efficacy in real world practice (as measured by progression free survival)~   "
9199|NCT03446443|"~     This is a Randomized, Positive -Controlled, Multi-center Trial enrolling 240 subjects with~     Bacterial Vaginosis who will be randomized at a ratio of 1:1 to receive active Honghe Fujie~     lotion or Metronidazole Suppositories. The primary objective is to assess the safety and~     tolerability of Honghe Fujie lotion compared to Metronidazole Suppositories.~   "
8825|NCT03451357|"~     Understanding the risk of dependence and its severity before hospital discharge for stroke is~     important for health and social care planning as instrument to prioritize people where the~     assistance is more appropriate in a context o limited resources and avoid the gap across the~     health care continuum. The goal is to conduct an assessment, which will identify the~     patient's needs. In doing so, the team, along with family may effectively coordinate, plan~     and implement any steps necessary to ensure a safe and healthy environment for the patient.~      The main study's objective is to asses which factors are associated with outcome of~     dependence after stroke and propose a suitable instrument for identifying patients in higher~     risk for needing formal care from health and/or social care providers.~   "
8826|NCT03451344|"~     Background: Relapse is very common in patients with illicit drug use disorder and contributes~     to a series of bad consequences that substantially impact patients' physical and social~     functions. Due to the limited existence of effective addiction treatment, the majority of~     patients with drug use disorder could not access help when needing. Mobile health (mHealth)~     offers a potential solution to improving recovery outcome for patients in community.~      Objective: This paper is a protocol for a randomized controlled trial (RCT) of a smart phone~     application called community-based addiction rehabilitation electronic system (CAREs) . This~     interactive system consists of an APP for clients and a webpage for service providers, with~     the aim of teaching clients craving and emergency coping skills and helping service providers~     to improve work efficiency and effectiveness in community.~      Methods: A randomized controlled trial(RCT) will be conducted. Sixty drug illicit users who~     are newly ordered to undergo community rehabilitation will be recruited from the community in~     Shanghai. Participants will be 1:1 randomly assigned to receive integrated community~     rehabilitation by using CAREs or only receiving routine community rehabilitation for 6~     months. Corresponding anti-drug social workers will provide service and monitor participants'~     drug use behavior in accordance with the routine work-flow. Outcomes will be assessed at~     baseline and in the 6th month. The primary study outcome is the performance on illicit drug~     urine test which will be carried on regularly twice per week during the study period.~     Secondary study outcomes include days that participants interact with anti-drug social~     workers, and the decrease rate of addiction-related issues severity index.~   "
8827|NCT03451331|"~     This is a randomized phase 2 trial of gemcitabine + carboplatin + nivolumab or gemcitabine +~     oxaliplatin + nivolumab for the treatment of cisplatin-ineligible patients with metastatic~     urothelial cancer. Randomization will be stratified on the metastasis status (lymph node only~     vs. other metastatic sites).~   "
8828|NCT03451318|"~     The aim of this study is to compare the efficacy and safety of drug therapy, tonsillar~     adenoidectomy only, orthodontic treatment only and tonsillar adenoidectomy plus orthodontic~     treatment in children with obstructive sleep apnea hypopnea syndrome (OSAHS) and~     malocclusion.~      In this study, we hope to improve children's OSAH in function, three-dimensional shape and~     subjective and objective symptoms of sleep breathing through tonsillar adenoidectomy plus~     orthodontic treatment.~   "
8829|NCT03451305|"~     Vertebroplasty in the symptomatic osteoporotic vertebral fracture has become increasingly~     popular. However, there have been some limitations in restoring the height of the collapsed~     vertebrae and in preventing the leaking of cement. In the severely collapsed vertebrae of~     more than two thirds of their original height, vertebroplasty is regarded as a~     contraindication. We tried postural reduction using a soft pillow under the compressed level.~     This study was undertaken to investigate the effectiveness of the combination of postural~     reduction and vertebroplasty for re-expansion and stabilization of the osteoporotic vertebral~     fractures. single level vertebral compression fracture were treated with postural reduction~     followed by vertebroplasty. We analyzed the degree of re-expansion according to the onset~     duration.~   "
8830|NCT03451292|"~     This is a phase 3, multicenter, randomized, controlled, parallel-group, and open-label~     clinical study to evaluate the efficacy of standard medical treatment (SMT) + Albutein 20%~     administration versus SMT alone in subjects with decompensated cirrhosis and ascites. The~     study population will consist of subjects being discharged after hospitalization for acute~     decompensation of liver cirrhosis with ascites (or with prior history of ascites requiring~     diuretic therapy) with or without acute-on-chronic liver failure (ACLF) at admission or~     during hospitalization but without ACLF at discharge.~   "
8831|NCT03451266|"~     The objective of the study is to determine whether administration of vitamin C (1.5g/6 hours)~     in the first three days post-partum reduces the amount of extravascular lung water assessed~     by lung ultrasound in patients with severe preeclampsia.~   "
8832|NCT03451253|"~     This pilot study will examine the benefit of this amino acid based hydration solution in~     patients with IBD who have undergone a total colectomy and have either ileostomies or~     jpouches. Findings from this study and possible future studies could have broad implications~     for patients with malabsorption resulting from many underlying conditions, including IBD.~   "
8833|NCT03451240|"~     The primary objective of the Resilience Study is to determine the impact of the Corporate~     Athlete® Resilience product through recalibrating mindset and changing resilience supportive~     behavior.~      Analysis will be performed via Survey and Study Interviews (two methods) to determine how the~     CAR Training recalibrated and impacted the Research Participants mindset and resilience~     state.~      1. Tool: Stress Mindset Measure-General (SMM-G)~      Additional analysis will evaluate participants' engagement in behavior changes in the first~     30 days.~      2. Tool: Energy Management Behaviors.~      Secondary objectives include further analysis to determine if the intervention group~     demonstrated significant improvements in the following measures:~      1. Brief Resilience Scale (BRS)~      2. Public Health Surveillance Wellbeing (PHS-WB)~      3. Sleep Habits (Rand MOS)~      4. Health, Wellbeing and Productivity (SF36, HPQ)~      5. Work Productivity and Activity Impairment (WPAI)~      6. Brief Cope~      7. Perceived Stress (PSS)~      In addition, demographic assessments will be collected.~   "
8834|NCT03451227|"~     To evaluate the safety and efficacy of dexmedetomidine and compare this to a current~     technique commonly used at TGH for sedation in patients undergoing ablation procedures for~     atrial fibrillation (AF) and atrial flutter.~      The investigators hypothesise that dexmedetomidine will be at least equivalent to, or more~     so, in terms of effectiveness and safety, when compared to midazolam and remifentanil for~     sedation during ablation procedures.~   "
8835|NCT03451214|"~     The purpose of this study is to determine the effect of different dietary zinc intakes on~     fatty acid metabolism and other zinc biomarkers~   "
8836|NCT03451201|"~     To study the effect of 8 week high-intensity interval training (HIIT) compared with moderate~     intensity (MCT) interval training and sedentary patients(CON) with type 1 diabetes. Adult~     T1DM patients without known complications are randomised in blocks into these 3 groups~     according to their baseline flow mediated dilation (FMD). After 8 week exercise training, the~     main outcome, FMD, is re-evaluated. Additional variables such as VO2 peak for cardiovascular~     fitness, oxidative stress and endothelial independent vasodilation to study vascular rigidity~     are also evaluated.~   "
8837|NCT03451188|"~     EDS (Ehlers-Danlos syndromes) form a heterogeneous group of hereditary connective tissue~     pathologies, which present a characteristic triad: cutaneous hyperelasticity, articular~     hyperlaxity and connective tissue fragility.~      The innumerable sprains and dislocations of all the joints require recurrent immobilizations~     and are responsible for a musculoskeletal handicap, chronic pains and a great fatigability,~     resounding on the quality of life of the patient.~      The use of custom-made compression garments seems to provide relief from pain, especially~     nociceptive pain and in stabilizing joints by proprioceptive effect.~      The SEDCARE study is an observational monocentric, non-comparative study. 76 patients will be~     followed in this study for 2 years during which they will wear compression custom-made~     garments (Cerecare®).The main objective of this study is to demonstrate the effectiveness of~     pressure garments Cerecare in the EDS, especially in terms of joint pain.~   "
8838|NCT03451175|"~     This study evaluates the reproductibility (quantitative and qualitative) of cystometry in~     mutiple sclerosis patients.~   "
8839|NCT03451162|"~     This first-in-human, Phase 1, open-label, multicenter, dose-escalation study will evaluate~     the safety, tolerability, and PK of DHES0815A as a single agent in participants with advanced~     and/or metastatic HER2-positive breast cancer for whom established treatment has proven~     ineffective or intolerable or is unavailable. The study may include a dose-expansion cohort~     (based on an ongoing assessment of the totality of data obtained in this study) to further~     assess safety, tolerability, PK, and preliminary anti-tumor activity.~   "
8840|NCT03451149|"~     A novel radiofrequency (RF) wire created by Baylis Medical (Montreal, CAN) is an FDA cleared~     device commonly used for percutaneous recanalization procedures. This wire has an active tip~     that delivers focused RF energy and has been applied for many procedures such as percutaneous~     transseptal left heart access, recanalization of central vein occlusion, recanalization of~     arterial occlusion, and recanalization of bile duct occlusion. There has been no study~     investigating the use of the RF wire for TIPS creation in clinical practice with humans.~     Having promising results of an experimental feasibility investigation in swine, the~     investigators are seeking to assess the feasibility and safety of the RF wire to cut through~     tissue in the liver while creating TIPS in the clinical setting.~   "
8841|NCT03451136|"~     This study establishes the relationship between cervical length and whether it can be used to~     predict haemorrhage and preterm delivery in cases of placenta previa.~   "
8842|NCT03451123|"~     The primary objectives of this study are:~        1. Determine the percentage of patients whose surgical plan would change with FET-PET/MRI~          compared to MRI alone.~        2. Determine the percentage of patients who have residual tumor after surgery detected with~          FET-PET/MRI.~      A secondary objective of this study is:~      1) Perform preliminary correlations between the pre- and post-surgical metabolic tumor~     volumes measured with FET-PET/MRI to progression free survival.~   "
8843|NCT03451110|"~     This study will be conducted to evaluate the effect of lemborexant 10 milligrams (mg) (at~     steady state) on the pharmacokinetics (PK) of a single-dose combined oral contraceptive,~     Loestrin 1.5/30 (containing 0.030 mg of ethinyl estradiol and 1.5 mg of norethindrone), and~     to evaluate the effect of fluconazole 200 mg (at steady state) and a single dose of~     famotidine 40 mg (an H2 blocker) on the PK of a single oral dose of lemborexant 10 mg.~   "
8844|NCT03451097|"~     Evaluation of Severity of Heart Failure in Children Attending Cardiology Unit, Assiut~     University Children Hospital~   "
8845|NCT03451084|"~     This is a multicenter, single arm, non-randomised Phase IIA Study to evaluate ASLAN003 as a~     monotherapy in patients with AML.~      AML patients who are ineligible for standard treatment including, but not limited to the~     following conditions, will be enrolled in the study:~        -  Newly diagnosed patients who are ineligible for standard therapy i.e., standard dose~          induction chemotherapy and reduced dose chemotherapy~        -  Patients with relapse from prior remission~        -  Patients with failed response to prior therapy including chemotherapy, hypomethylating~          agents, and bone marrow (BM) transplantation~   "
8846|NCT03451071|"~     Human papillomavirus (HPV)-related cancers are on the rise in the United States. Furthermore,~     greater than 90% of cervical cancer cases are attributable to HPV, and cervical cancer~     disproportionately affects women of color in both incidence and mortality. Due to low HPV~     vaccine uptake in the US, innovative approaches to vaccinating vulnerable populations are~     necessary in order to maximize the cancer prevention potential of this vaccine. The~     puerperium is a time period when women are engaged in the healthcare system and have almost~     universal access to affordable health care. Two prior studies have shown that postpartum HPV~     vaccination is acceptable to patients, and high rates of vaccination were achieved in these~     primarily Hispanic populations. However, data show that the immune response in young women is~     less robust than in adolescents, and no studies have examined immunogenicity in postpartum~     women specifically. We propose an HPV vaccination pilot study in women who receive postpartum~     care at University of Alabama at Birmingham (UAB) hospital. We will examine the~     acceptability, uptake and immunogenicity of the vaccine in the postpartum setting.~   "
8847|NCT03451058|"~     Traumatic brain injury (TBI) is one of the most frequent injuries affecting service members.~     Unfortunately, current neurocognitive assessment tools are unable to reliably detect mild TBI~     more than a few days post- injury. Therefore, development of advanced systems for assessment~     and diagnosis of TBI are a top priority within Department of Defense. This project aims to~     evaluate a combined electroencephalography (EEG) and eye tracking system capable of assessing~     compromised cognitive function stemming from TBI, with the goal of enhancing operational~     readiness and aiding in diagnosis, improving health care and rehabilitation for affected~     military personnel.~   "
9200|NCT03446430|"~     The aim is to compare a new technique for assessing local and regional arterial stiffness:~     the Laser Doppler Vibrometry with the reference techniques, the applanation tonometry and~     echotracking.~   "
8848|NCT03451045|"~     This is a Phase 2 multicenter, double-blind, randomized, placebo-controlled study assessing~     the efficacy and safety of lenabasum for the treatment of cystic fibrosis in patients 12~     years of age or older. Approximately 415 subjects will be enrolled in this study at about 100~     sites in North America, Europe, and Australia. The planned duration of treatment with study~     drug is 28 weeks.~      Study drug will be lenabasum 20 mg BID, lenabasum 5 mg BID, and placebo in a 2:1:2 ratio.~   "
8849|NCT03451032|"~     Prospective, multicenter study to evaluate tolerability, adherence and efficacy of a 28-day~     course of TAF/FTC/RPV, an HIV post-exposure prophylaxis after a potential sexual or blood~     exposure to HIV.~      At baseline, participants are prescribed TAF/FTC/RPV and a blood test. At W6, all~     participants are contacted by phone to evaluate completeness and tolerability of the~     TAF/FTC/RPV regimen.~   "
8850|NCT03451019|"~     Sevelamer hydrochloride (SE) can increase intestinal calcium absorption in contrast to~     lanthanum carbonate (LA). Study compared effect of LA and SE on serum and urine phosphate and~     calcium, and hormones regulating mineral-bone metabolism.~   "
8851|NCT03451006|"~     This study will test whether chronic metformin administration will improve longevity of the~     cell, improves its machinery by reducing aging-related biochemical parameters and thereby~     improving physical performance, as measured by short physical performance battery test.~   "
8852|NCT03450993|"~     This is a pilot study to test the effects of the SMART-3RP (Stress Management and Resiliency~     Training Relaxation Response Resiliency Program) on quality of life, mental health,~     arrhythmia burden, and heart rate variability (HRV) in patients with paroxysmal atrial~     fibrillation (PAF).~   "
8853|NCT03450980|"~     Develop and evaluate a new smartphone based app to screen for and measure eye misalignment~     (strabismus). The investigators will validate the app against simulated strabismus of known~     magnitude and common clinical tests. They will evaluate the app as a screening tool in high~     risk populations, to determine the sensitivity and specificity. They hypothesize that the app~     can measure to within 2 units (prism diopters) of the ground truth, and that it will be~     correlated with gold standard tests.~   "
8854|NCT03450967|"~     -  Clinical Phase: phase II single arm study~        -  Primary Objectives: Response rate~        -  Number of Subjects: 27 patients~        -  Study Population: recurrent or metastatic head and neck squamous cell carcinoma~        -  Investigational Product(s), Dose, and Mode of Administration:~      Durvalumab 1500mg plus tremelimumab 75mg via IV infusion Q4W, starting on Week 0, for up to a~     maximum of 4 doses/cycles followed by durvalumab monotherapy 1500mg via IV infusion Q4W,~     starting 4 weeks after the last infusion of the combination until progression.).~      Proton therapy 5 GyE x 5 fractions~      - Study Assessments and Criteria for Evaluation: Safety Assessments: according to NCI CTCAE~     version 4.0 Efficacy Assessments: according to RECIST version 1.1~      - Statistical Methods and Data Analysis: PFS: from the date of treatment to the date of~     progression or death or last follow-up OS: from the date of treatment to the date of death or~     last follow-up~      - Sample Size Determination: Patients must have a histologically confirmed diagnosis of~     HNSCC. In this phase II study, up to approximately 27 eligible patients will be enrolled. It~     is anticipated that full accrual to this study will take approximately 24 months.~      H0: Objective response rate ≤10% H1: Objective response rate ≥35% According to Simon's~     two-stage optimal design (power of 90% and one-sided alpha of 0.05), this study needs total~     27 evaluable patients. At the first stage, 11 patients would be enrolled. If two or more~     among them achieve objective response, the study will go forward the second stage. At the~     second stage, 16 additional patients (total 27 patients) would be enrolled. Among the total~     27 evaluable patients, six or more objective responses are necessary for this drug to be~     evaluated further in the group of R/M HNSCC~   "
8855|NCT03450954|"~     A retrospective study including 22 patients who have undergone amniotic membrane transplant~     in our unit up till 2016. Confocal microscopy and anterior segment optical coherence~     tomography (ASOCT) were performed to assess the retention of amniotic membrane and to detect~     any corneal structural changes. Comparison was made with 5 controls who had bullous~     keratopathy awaiting endothelial keratoplasty.~   "
8856|NCT03450928|"~     Per-Oral Endoscopic Myotomy (POEM) is increasingly used for the treatment of achalasia. In~     published series, a 12cm-POEM is usually performed. Surgical myotomy is typically shorter~     (8cm). The clinical efficacy of both procedure is comparable.~      This study intends to investigate if clinical outcomes of POEM depends on the length of~     esophageal myotomy, in patients with classic-type achalasia (type I and type II according to~     Chicago Classification)~   "
8857|NCT03450915|"~     The pivotal Phase 3 trial plans to enroll a total of 9,630 participants aged 50+ over two~     years. Participants will be immunized twice with the M-001 universal influenza vaccine~     candidate or placebo and then followed for up to 2 seasons. The trial will evaluate the~     number of influenza cases in each group and the severity of illness during the follow up~     period.~   "
8858|NCT03450902|"~     The purpose of this study is to determine whether combination therapy with Chinese herbal~     formula, Yiqi Suoquan granule, and acupuncture is effective in the treatment of female mixed~     urinary incontinence.~   "
8859|NCT03450889|"~     Serrated polyposis syndrome (SPS) is a condition characterized by the presence of multiple~     serrated polyps (SPs) spread throughout the colorectum and is associated with an increased~     risk of colorectal cancer (CRC). SPS is defined by the World Health Organization (WHO) as the~     presence of at least 5 SPs proximal to the sigmoid colon, of which 2 ≥10 mm in size (WHO~     criterion 1), the presence of at least 1 SP proximal to the sigmoid and a first degree~     relative with SPS (WHO criterion 2), or more than 20 SPs spread throughout the colon~     (WHO-criterion-3). In practice only WHO 1 and WHO 3 criteria are used.~      The condition seems rather common and more prevalent than other polyposis syndromes such as~     familial adenomatous polyposis (FAP) (1:13.000).~      Several retrospective studies have shown that patients with SPS have an increased risk of~     developing CRC during endoscopic surveillance. Close endoscopic surveillance to prevent~     malignant progression of polyps has therefore been advised by several expert groups. However,~     due to a shortage of prospective data the optimal treatment and surveillance approach is~     largely unknown.~      The current study aims to prospectively evaluate the effectiveness and feasibility of a~     personalized surveillance protocol for patients with SPS to prevent CRC that is being used in~     several Dutch and Spanish hospitals. Furthermore, the polyp burden, colonoscopy complication~     risk and rate of conversion from endoscopic surveillance to colorectal surgery will be~     examined.~      For this purpose, all eligible SPS patients are prospectively enrolled 2013 onwards, and~     surveyed according to the study protocol. Based on the amount and characteristics of the~     polyps encountered during surveillance colonoscopy, the next colonoscopy will be scheduled~     after either 1 year or 2 years.~      Patients will undergo surveillance after 1 year in case of:~        -  Advanced adenoma (≥ 10 mm and/or high-grade dysplasia and/or 25% villous component)~        -  Serrated polyp ≥ 10mm and/or SP containing dysplasia~        -  Cumulative ≥5 sessile serrated polyps (SSPs) (irrespective of size), adenomas~          (irrespective of size) and/or hyperplastic polyps (HPs) ≥5mm~        -  Surgery needed during previous (clearing or surveillance) endoscopy~      Patients will undergo surveillance after 2 years in case none of above is reached~   "
8861|NCT03450863|"~     The purpose of this study is to collect information about Fiasp® to evaluate how effective~     Fiasp® is in treating elevated blood sugar in patients with type 1 diabetes, compared with~     the participant's previous insulin treatment. The study will also assess how satisfied the~     participants are with the treatment with Fiasp® and the impact of the treatment on quality of~     life. The study has also been set up to learn more about how effective Fiasp® is in~     controlling the glucose levels during the day and night. The duration of the study is~     expected to be approximately 2 years. The participation is expected to be approximately 6-8~     months for each patient.~   "
8862|NCT03450850|"~     This is a Phase 2 study in subjects with WHO Grade III Anaplastic Astrocytoma (G3~     astrocytoma) who had progressive disease during first or second line treatment and who have~     not previously received any BEV or any experimental agents.~   "
8863|NCT03450837|"~     Anabolic androgenic steroids (AASs) have been associated with coronary artery disease (CAD).~     The illicit use of these substances also leads to a remarkable decrease in high-density~     lipoprotein (HDL) plasma concentration, which could be a key factor in the atherosclerotic~     process. The investigators tested the functionality of HDL by cholesterol efflux and~     antioxidant capacity and its association with CAD in young men.~   "
8864|NCT03450824|"~     This study aims to research on the relationship between knee varus and patellofemoral pain.~     The standardized standing whole-lower-extremity radiographs of the participants will be~     taken. The hip-knee-ankle angle will be obtained from the radiographs. The hip-knee-ankle~     angle of the participants with knee varus in the study group and the hip-knee-ankle angle of~     the participants with knee varus in the control group will be compared.~   "
8865|NCT03450811|"~     Post operative acute urinary retension or voiding dysfunction are complications after~     inguinal hernia repair and they cause a great deal of discomfort and stress to patients.~     Furthermore, they can also increase hospital costs by increasing hospital stay, and by~     growing the need for outpatient appointments after an elective surgical procedure. Some~     studies recommend prophylactic alpha blockers to minimizing these adverse effects.~      Investigators aimed to determine the changes of uroflowmetric values for male patients~     following elective inguinal hernia repair.~   "
8866|NCT03450798|"~     Peripheral nerve block is an ideal choice for lower limb surgery because of the peripheral~     site of the surgical procedure and the ability to block pain pathways at multiple levels. On~     the contrary to other anesthetic techniques, as spinal or general anesthesia, properly~     performed peripheral nerve blocks bypass adverse events as hemodynamic instability and~     respiratory complications, properly treat post-operative pain leading to early hospital~     discharge. Additional advantages of peripheral nerve blocks are that they can be used in~     patients receiving anti-coagulants or lumbo-sacral disease inaddition to avoidance of airway~     instrumentation.~      Recently, there has been a significant interest in regional anesthesia and peripheral nerve~     blockade. This is facilitated by a significant advance of the research in this field and~     availability of better equipment facilitating regional anesthesia.The aim of this study was~     to assess the efficacy and safety of SOFT block (sciatic-obturator-femoral nerve block~     technique) in comparison with spinal anesthesia in patients undergoing surgery for fixation~     of open tibial fractures using Ilizarov external fixator.~   "
8867|NCT03450785|"~     Central venous catheters are frequently used for monitoring haemodynamic status and rapidly~     delivering fluid therapy during the peri- and postoperative periods. Indwelling central~     venous catheters are typically used 7-14 days postoperatively for additional monitoring and~     treatment, but patients may develop asymptomatic catheter-related thrombosis, leading to~     life-threatening pulmonary embolism and death. Early detection helps to avoid such~     complications. This prospective observational study investigated the risk factors associated~     with catheter-related right internal jugular vein thrombosis in pediatric patients. The study~     enrolled 80 pediatric patients who were scheduled to receive central venous catheter. To~     detect thrombus formation, Doppler ultrasound examinations from the thyroid cartilage level~     to the supraclavicular region were used after CVC placement and on each of the following days~     until the catheter was removed.~   "
8868|NCT03450772|"~     This will be an open-label, randomized, multicenter, cross-over study in 60 subjects with PEI~     delivering data of 60 subjects for Pancreatin Enteric-Coated Capsules 25000 and of 60~     subjects for Pancreatin Enteric-Coated Capsules 10000. The study will be conducted in up to~     10 sites in China.~   "
8869|NCT03450759|"~     This study will evaluate pharmacokinetics (PK) of four different formulations with different~     release profiles of AZD9977 (PART A) in the fasted state, and one of the formulation will be~     selected for further development (Part B). In Part B, the influence of food on the PK of~     AZD9977 will be evaluated~   "
8870|NCT03450746|"~     The air we breathe contains 21% of oxygen. Oxygen is vital for the cells ability to produce~     energy and without it we could not survive. Oxygen normally exists as a molecule consisting~     of two atoms, O2. It has two unpaired electrons and thus is unstable and willing to accept~     electrons to become stable. During the formation of ATP a transportation of electrons happens~     over the inner membrane of the mitochondria's. Oxygen can accept these and is thereby reduced~     to water. Normally about 4% is not fully reduced and instead produces superoxide. Superoxide~     is transformed to hydrogen peroxide by superoxide dismutase (SOD) and then into oxygen and~     water by catalase and glutathione peroxidase. It is also possible for hydrogen peroxide to be~     converted to hydroxyl radicals by Fenton reactions. All these radicals are called reactive~     oxygen species (ROS) and they are highly reactive and capable to induce damage to cellular~     components as proteins, DNA and lipids. Under normal conditions SOD, catalase and glutathione~     peroxidase work as anti-oxidative compounds to prevent oxidative stress and damage. However,~     under hyperoxic conditions these defences can be overwhelmed, resulting in the formation of~     excess ROS and thus oxidative damage.~      During general anaesthesia the use of supplemental oxygen to avoid life-threatening~     hypoxaemia has been common practice for many years and a fixed fraction of inspired oxygen~     (FiO2) ranging from 0.3 to 1.0 is often used. This lead to supranormal levels of oxygen in~     the lungs and most of the patients also have supranormal levels of partial pressure of~     arterial oxygen in their blood.~      This study will examine otherwise healthy ambulant patients undergoing minor orthopaedic~     surgery during general anaesthesia to elucidate metabolic and physiological changes caused by~     ventilation with FiO2 0.50 for at least 45 minutes using standard respiratory settings.~     Exhaled breath condensate (EBC) and arterial blood will be collected prior to and after~     surgery. The two EBCs and two blood samples will be stored at -80°C for analysis after all~     patients have been included. The metabolic changes will be measured with NMR technique and~     multivariate statistical analysis comparing baseline values with values obtained after oxygen~     exposure.~      Collapse of the small airways induced by anaesthesia and FiO2 will be evaluated by measuring~     resistance and reactance with airway oscillometry after surgery compared to a baseline~     measurement before surgery.~   "
9201|NCT03446417|"~     This is a Phase I, open-label, multicenter, sequential dose-escalation study to evaluate the~     safety, tolerability, pharmacokinetics, and preliminary efficacy of ZN-e4 administered orally~     in subjects with advanced non-small cell lung cancer (NSCLC) with activating epidermal growth~     factor receptor (EGFR) mutations who have progressed following treatment with an EGFR~     inhibitor.~   "
8871|NCT03450733|"~     This study is in response to the Food and Drug Administration (FDA) call to all manufacturers~     with 510(k) clearance for metal-on-metal (MoM) total hip arthroplasty (THA) devices to~     conduct postmarket surveillance studies. MicroPort has various acetabular shells, acetabular~     liners, fixation screws, femoral heads, femoral stems, modular necks, and proximal bodies~     currently cleared for MoM indications. Together these components comprise the Wright Medical~     Technology (WMT) MoM THA System. The primary objective of the study is to determine the~     incidence of adverse local tissue reactions (ALTR) in each THA implanted with the WMT MoM THA~     System overall and for each yearly cross-section from 4-year to 8-year post implant.~   "
8872|NCT03450720|"~     This is a single dose, open label study in adult male subjects with cystic fibrosis to~     investigate the pharmacokinetics, safety and tolerability of GLPG2737.~   "
8873|NCT03450707|"~     This is a randomized, double-blind, placebo controlled study to investigate the effect of~     intravenous thiamine (vitamin B1) on lactate, cellular oxygen consumption, global oxygen~     consumption and biomarkers of neurologic injury after out-of-hospital cardiac arrest (OHCA).~     .~   "
8874|NCT03450694|"~     The aim of the study is to assess the efficiency and limitations of ultrasound in detecting~     and characterizing laryngeal anatomy and study of some laryngeal disorders and their~     ultrasonographic appearance.~   "
8875|NCT03450681|"~     Approximately 40% of patients undergoing total knee arthroplasty develop acute to moderate~     post operative pain. Furthermore 20-30% develop chronic post operative pain. The objective of~     this work is to study the effectiveness and safety of pulsed radiofrequency of the saphenous~     nerve realized during the pre-operative period of total knee arthroplasty. The study design~     is a randomized, blinded clinical trial. Patients scheduled for total knee arthroplasty are~     divided into two groups. The first group procedure consists in pre-operative pulsed~     radiofrequency under ultrasound guidance of the saphenous nerve and standard postoperative~     pain management by the pain clinic. The second group receives only the standard postoperative~     pain management by the pain clinic. Patient follow ups are performed 3 times (after 2 weeks,~     2 months and 6 months) within a period of 6 months, evaluating pain severity using the VAS.~   "
8876|NCT03450668|"~     The mOm Incubator is a collapsible infant incubator designed to provide a level of~     thermoregulation that meets the standards set for conventional incubators whilst being low~     cost and space-saving. Babies recruited will be clinically stable, at least 30 weeks~     gestational age and require at least 48 hours incubator care. A standard or test incubator~     will be used for the first 24 hours chosen randomly, then the baby will be moved to the over~     arm for a further 24 hours.~   "
8877|NCT03450655|"~     Given the increasing prevalence of obesity, there is an urgent need to find better strategies~     to promote physical activity in the community. The present study will invite 70-year-olds~     with central (abdominal) obesity to participate in a 10-week aerobic exercise program.~     Participants will be randomly assigned to one of two equally large groups. The first group~     will complete the exercise program in instructor-led groups. The second group will complete~     the program at home with the help of an on-line video.~   "
8878|NCT03450642|"~     Acute appendicitis is a common condition requiring urgent surgery but is often difficult to~     distinguish from other non-surgical conditions such as urinary infections, pelvic~     inflammatory disease and non-specific abdominal pain. Delay in diagnosis can result in~     significant morbidity and potential mortality. Currently, there is no one diagnostic test~     available and raised inflammatory markers such as C-reactive protein (CRP) and White Blood~     Count (WBC) along with an evolving clinical picture, help guide management. However, these~     markers are slow to respond to inflammation and are non-specific for appendicitis. The~     Complement cascade is an immune response to inflammation and infection involving three~     pathways which activate a number of proteins in the blood. Monitoring the absolute levels of~     these proteins should provide a faster and differential diagnostic test. The investigators~     propose a pilot trial to measure concentrations of Complement cascade activation biomarkers~     in the blood during hospital admissions for acute right lower abdominal pain, a symptom of~     appendicitis. Further, analysis of the differential Complement cascade pathway activation~     could potentially identify underlying pathology allowing the clinicians to target therapies.~   "
8879|NCT03450629|"~     The study will be conducted to evaluate the efficacy and safety of topical administration of~     brimonidine tartrate ophthalmic suspension compared with brimonidine tartrate ophthalmic~     solution.~   "
8880|NCT03450616|"~     This study is being conducted to determine how the PICO™ Negative Pressure Wound Therapy~     compares to standard care treatment for venous stasis ulcers, as there is no evidence to~     date.~   "
8881|NCT03450603|"~     Exacerbations of chronic obstructive pulmonary disease (COPD) are unfavourable events in the~     course of disease for most COPD patients. Published evidence indicates a significant impact~     of exacerbations, especially if frequent, on patients' health-related quality of life (HRQL),~     disease progression, mortality, health care utilisation and costs. However, the~     severity,evolution and outcome of an exacerbation may differ significantly between patients -~     some patients will recover completely in a short period of time while others may die. The~     identification of risk factors for an adverse outcome could help in distinguishing patients~     who require more intense management in order to prevent failures, achieve satisfactory~     recovery and reduce the negative clinical and socioeconomic impact of exacerbations.~   "
8882|NCT03450590|"~     A patient undergoing ophthalmic arterial chemosurgery may experience a sudden, profound~     decrease in lung compliance when the microcatheter is in the ICA or ophthalmic artery.~     However, underlying pathophysiology of the respiratory complication is unknown. In this~     study, the investigators are going to investigate the relation between underlying balance of~     parasympathetic and sympathetic tone and the respiratory complications by analyzing heart~     rate beat-to-beat variability.~   "
8883|NCT03450577|"~     The IBS registry is an observational, multi-center, real-world registry of stenting in~     coronary bifurcation lesions that will collect information on procedures and outcomes from~     various participating centers.~      The aim of this registry is to investigate long-term clinical results and predictors of~     adverse outcomes after PCI for coronary bifurcation lesions among various participating~     centers.~   "
9202|NCT03446404|"~     This study will help us decide the best way to image the knee for diagnostic purposes: Knee~     computed tomography vs knee x-ray. The computed tomography will provide a weight bearing 3D~     view.~   "
8884|NCT03450564|"~     The cluster randomized controlled trial will be done in Pastoralist community of Afar region,~     Ethiopia for a total of nine months. There will be three arms in the study. The type of~     randomization will be a cluster randomized controlled trial where kebele are randomized to~     two different interventions and control groups together. These interventions are women~     education to use family planning and male education/involvement to enhance family planning~     use in the community.~   "
8885|NCT03450551|"~     To investigate each treatment modality in its optimal environment to avoid operator~     experience bias. Therefore we propose to operate out of three specialist centres with~     specific units providing one modality alone Which of the three orthodontic appliances does~     achieve best clinical progress, produce least discomfort to the patient, minimize the time~     taken for completion of treatment and maximize compliance.~   "
8886|NCT03450538|"~     This study is aimed at assessing the survival benefit potentially associated with CT scans~     for trauma patients in an urban lower-middle income setting.~   "
8887|NCT03450525|"~     The study aims to assess whether time between injury and first Glasgow Coma Scale measurement~     will affect its predictive value.~   "
8888|NCT03450512|"~     This is the first prospective study on digestive affections in an homogeneous cohort of~     hematological patients. These affections are unknown in neutropenic patients with digestive~     symptoms after induction or consolidation courses pour AML although causing high~     morbi-mortality rates (infections, denutrition, loss of autonomy…).~      The aim of the study is to evaluate incidence of NE by clinical signs and with a systematic~     CT scan performed at day 5 of fever during aplastic period. An early diagnostic could~     decrease complications and evaluate gravity criteria which could imply surgery therapy.~      The physician will performe a CTscan with injection during the induction and/or every~     consolidation, at the same time as the thoracic CTscan (to research an invasive fungal~     bronchopulmonary infection), in front of a febrile neutropenia with persistent fever after 5~     days of antibiotics and presence of digestive signs.~      The clinical, microbiological, radiological symptoms will be registered at every time of~     febrile neutropenia with digestive symptoms at induction and each consolidation courses. The~     patient will be get out of the study when the AML is refractory, hematopoietic stem cell~     transplantation is required or if whenever he want. The last visit will be at the end of~     consolidation courses.~   "
8889|NCT03450499|"~     This randomized double blind study will be conducted in pregnant woman planned for non~     elective cesarean section under spinal anesthesia. Ketamine group will receive intravenous~     0.25 mg/kg and placebo group will receive same amount of normal saline after spinal~     anesthesia prior to skin incision. Postoperative outcomes measures are total opioid~     consumption and pain scores for 24 hrs.~   "
8890|NCT03450486|"~     Osteoarthritis is a prevalent and disabling condition. Exercise is recommended to maintain~     strength and mobility, and to decrease pain. However, acute bouts of exercise have~     conflicting outcomes: they are fatiguing and they also can increase coordination and balance.~     The purpose of this study is to assess the effects of a single bout of exercise (30 minutes)~     on balance performance of individuals with self-identified unilateral knee osteoarthritis.~     Balance will be assessed using the star excursion balance test before and after the exercise~     session. Differences in performance between the two star excursion balance tests will reflect~     the changes due to exercise. The changes between their balance performance on each limb will~     reflect the changes due to osteoarthritis.~   "
8891|NCT03450473|"~     Large abdominal wall hernias are surgically challenging to repair and often associated with~     significant postoperative complications. Risk factors associated with surgical site~     complications, such as infection and wound dehiscence, include obesity, diabetes, and~     smoking. In these high risk patients, the placement of synthetic mesh increases the risk of~     mesh infection, enterocutaneous fistula formation, and mesh explantation. One of the larger~     studies of risk factors associated with mesh explantation demonstrated concomitant~     intra-abdominal procedures have a greater than 6-fold increased hazard of subsequent mesh~     explantation. As an alternative to synthetic meshes, bioprosthetic meshes derived from the~     decellularization and processing of allogeneic or xenogeneic tissue sources have been~     introduced that can often allow the surgeon to treat the surgical site occurrences and~     salvage the repair without required mesh explantation. Low rates of mesh infection and~     explantation have been reported for bioprosthetic meshes and are recommended in these~     complicated patients by the Ventral Hernia Working Group, based on the best available~     clinical evidence. Despite widespread use of bioprosthetic mesh, there continues to be~     concern for complications associated with their use (i.e. high seroma and recurrence rates,~     etc.). This has led to the modification of these matrices by several industry leaders~     (Acelity, Cook, Integra, etc.) to include a fenestrated platform to allow for fluid to flow~     through the matrix upon implantation while supporting regeneration in complex abdominal wall~     reconstruction. To our knowledge, there are no clinical studies prospectively evaluating the~     long term clinical outcomes for abdominal wall reconstruction procedures involving~     fenestrated macropourous biologic matrices.This macroporous technology allows for tissue~     revascularization and integration of the biologic graft and thus an expected improvement in~     overall outcome. Bioprosthetic fenestrated materials such as Surgimend MP® were developed to~     assist with earlier incorporation and vascularization of the biologic graft while providing~     reinforcement of hernia repair. However, there is an absence of high quality prospective data~     regarding the use of these materials in complicated abdominal wall reconstruction, and no~     comparative data exists.~      This study is a prospective, case series study evaluating the efficacy and performance of~     SurgiMend MP® during complex ventral hernia repairs. This case series involves a biologically~     derived hernia mesh under its cleared FDA indication for hernia repair. Efficacy will be~     determined by quantifying surgical complications, hernia recurrence, and cost effectiveness~     endpoints.~   "
8892|NCT03450460|"~     Most people with moderate or severe TBI have difficulty returning to their usual social roles~     and activities. The OBIA has developed a program where peers (other individuals living with~     TBI) coach or mentor those with more recent brain injury. The objective of this project is to~     evaluate the feasibility of measuring the impact of the OBIA Peer Program on social~     participation and mood compared to a control group who have not received peer support yet.~      The proposed study will involve three phases. It will begin with a qualitative component~     (stakeholder interviews), then a pilot RCT, and end with more interviews to explore the~     success of the study intervention. A qualitative descriptive approach will be used at these~     first and last phases of the study. In Phase 1, interviews will be conducted with~     approximately 15 participants including individuals with moderate to severe TBI, caregivers,~     Mentors, OBIA staff members, and health researchers. Phase 2 will be a clinical trial,~     conducted with 60 participants. These participants will be randomized to one of three groups:~     a twice a week Program (n=20), a once a week Program (n=20), or the wait list control group~     (n=20). For Phase 3, a sub group of approximately 25 participants from Phase 2 who~     participated in the OBIA Peer Support Program will be asked to participate in a one-on-one,~     telephone/Skype interview. A sub-group of Mentors will also be asked to participate in a~     one-on-one, telephone/Skype interview.~      This research project will address the highest priority areas of strategies to enhance~     social participation and community life (personal relationships) and psychological~     strategies to improve mood, depression, and irritability, as identified in the ONF's Request~     for Proposals on Addressing Evidence Gaps in Moderate to Severe TBI Rehabilitation. The~     study will provide important results to inform a RCT (of appropriate size) on the impact of~     peer support on the social participation and mood of individuals with moderate to severe TBI.~     This study will then provide the best evidence to support the recommendation on a~     peer-supported relationship model of intervention, and inform future versions of the~     INESSS-ONF Guideline.~   "
8893|NCT03450447|"~     To summarise the outcomes of a treatment decision of patients with superficial esophageal~     carcinoma synchronously associated with head and neck cancer, that is endoscopic treatment~     for the superficial esophageal carcinoma plus surgery of the head and neck carcinoma.~   "
11711|NCT03413527|"~     This study will examine the effects of rTMS on the negative and positive symptoms of~     schizophrenia using 2 treatments in sequence applied to related brain areas.~   "
8894|NCT03450434|"~     A multicenter, double-blind, randomized, parallel-group comparative Phase II clinical study~     to assess the efficacy and safety of different doses of XC8 vs Placebo in patients with~     partly controlled bronchial asthma receiving stable treatment with low doses of inhaled~     corticosteroids with or without long-acting beta2-agonists during 12-weeks treatment period.~      Study design was developed by Pharmenterprises LLS, Russia in cooperation with Eurrus Biotech~     GmbH, Austria and FGK Clinical Research GmbH, Germany.~      The primary objective of the study was to evaluate the effect of different doses of XC8 on~     change in pre-bronchodilator forced expiratory volume in 1 second (FEV1) (% of predicted~     value) at Week 12 as compared to baseline at Week 0 vs. Placebo in patients with partly~     controlled bronchial asthma (BA).~   "
8895|NCT03450421|"~     Women undergoing laparoscopic abdominopelvic surgery with a planned, second look laparoscopy~     within 8-12 (+4) weeks will be enrolled. All subjects must undergo myomectomy with/without~     treatment of co-existing pathology e.g. (+/-) adhesions and/or (+/-) endometriosis, and/or~     (+/-) adenomyosis, and/or (+/-) ovarian cyst(s). The value of the second look laparoscopy~     (SLL) must be confirmed by the investigator to be of clinical benefit to the subject. The~     subject must be desirous of future fertility and willing to undergo the SLL to assess whether~     pathology (e.g. adnexal adhesions or endometriosis) exists which could be treated with a goal~     of improving their likelihood of conceiving and progressing to full term.~   "
8896|NCT03450408|"~     The investigators will compare, in a randomized clinical trial, two methods of placement~     (placement with a gloved hand vs. placement with a sterile speculum) of a Foley bulb~     transcervical dilator. The primary outcome is rate of infection.~   "
8897|NCT03450395|"~     The objectives of this study are to examine fecal bacterial population(s) and plasma~     cholesterol levels elicited by 40g of Oats and Cream of Rice over 6 weeks.~   "
8898|NCT03450382|"~     To study the difference between participants interested in a lifestyle change when enrolled~     in Hans Kai or not when comparing behaviour change, social support, self health efficacy and~     mental health. Hans Kai is a community based, peer led program that is low cost and self~     sustaining, which places participants through a 9 week health school to learn skills related~     to improving health such as nutrition, exercise, sleep, stress management etc. Once~     completed, participants form a Hans Kai group and continue meeting independently of health~     care providers~   "
8899|NCT03450369|"~     Acne vulgaris is a multifactorial disease caused by overgrowth of Propionibacterium acnes (P.~     acnes), impaction of hair follicles, excessive sebum production and hormonal dysregulation.~     Recent literature from the Human Microbiome Project has shown there are unique microbial~     signatures specific to healthy and acne disease states.~      From this data, the investigators hypothesize that by eliminating resident disease-associated~     bacterial strains and replacing them with health-associated strains, recurrences/fares of~     acne may be improved, mitigated, and prevented. Instead of current approaches which focus on~     eliminating all bacteria from the skin, the investigators aim to deliver healthy bacteria to~     restore the skin to a healthy state via this replacement therapy.~      The investigators aim to test this in a Phase Ib single application study evaluating the~     safety, tolerability, and clinical impact that a single application of NB01 has on adult~     subjects with moderate acne.~   "
8900|NCT03450356|"~     Goal of the current project is the development of a German-language test battery for a~     realistic investigation of core areas of social issues Cognition (emotion, perspective~     taking). This test battery should be used in the investigation of patients with~     neuropsychological disorders. Investigators plan to establish a German-version of the TASIT~     that is more sensitive and shorter in administration than the original TASIT.~   "
8901|NCT03450343|"~     The purpose of this study is to determine the safety and tolerability of adding oral~     azacitadine to the chemotherapy combination R-ICE. This study will also look at whether or~     not disease outcomes improve with the combination.~   "
8902|NCT03450330|"~     This study will treat patients with advanced NSCLC who have progressed following prior~     therapy. This is the first time this drug has ever been tested in patients, and so it will~     help to understand what type of side effects may occur with the drug treatment. It will also~     measure the levels of drug in the body and preliminarily assess its anti-cancer activity as~     monotherapy and in combination with Osimertinib.~   "
8903|NCT03450317|"~     Colorectal cancer (CRC) is the third most common cancer type in males and the second in~     females, accounting for about 693,900 deaths worldwide per year. Although the annual CRC~     mortality rate is still very high, it demonstrated a decline by 47% among men and 44% among~     women from 1990 to 2015. This decreasing trend may be attributed to improved screening, early~     detection as well as combined CRC treatment. In fact, the mortality rate is expected to~     reduce further by long-term use of chemopreventive agents that can prevent the development of~     neoplasms in the large bowel. Several decades of research both in clinic and laboratory has~     identified aspirin as an effective synthetic CRC chemoprevention drug.~      It is commonly accepted that aspirin exerts its chemopreventive effects by inhibiting~     catalytic enzymes cyclooxygenase (COX) -1 and COX-2 involved in prostaglandin synthesis. But~     the mechanism of its chemopreventive effect on CRC is not clearly understood. Other than CRC,~     aspirin also showed its potential inhibitory effects on some other types of solid cancer,~     such as pancreatic, lung, breast and prostate cancers. However, its effects on~     extragastrointestinal cancer types are still elusive due to lack of reliable supporting~     evidence from randomized clinical trials. Based on current knowledge, it is unclear why~     aspirin appears to inhibit CRC more than other cancers. This might be associated with the~     unique microenvironment comprising trillions of microbes in which CRC resides.~   "
8904|NCT03450304|"~     A comparative, observational, cross-sectional and prolective diagnostic test study, including~     patients that have had a right heart catheterization and were referred for a CT pulmonary~     angiography as part of their imaging workup protocol for pulmonary hypertension.~      Dual-energy computed tomography (DECT) pulmonary angiography was performed on each patient to~     obtain perfusion maps and do a quantitative analysis. Segments with and without perfusion~     defects according to significant differences in the quantitative values, were defined as~     compatible or not with chronic thromboembolism.~      To assess the accuracy of the method and evaluate its performance, these results were~     compared with the sole results from the right heart catheterization, known to be the gold~     standard diagnostic tool.~   "
8905|NCT03450291|"~     This study uses a computational task to examine differences in adaptive learning to both~     rewards and punishments between three groups: those who have recovered from anorexia nervosa,~     those who score highly on the EAT-26 (Eating Attitudes Test - 26 item version; an eating~     disorder symptom scale), and healthy controls. This task also allows the examination of pupil~     response (thought to reflect norepinephrine activity) in response to expected and unexpected~     wins and losses.~   "
8906|NCT03450278|"~     The current study Is a split-mouth Randomized Controlled Trial that was performed to~     investigate three dimensionally, using digital models and Cone Beam Computed Tomography~     imaging, the effect of micro-osteoperforations (MOPs) on the rate of tooth movement in a~     canine retraction model.~   "
8907|NCT03450265|"~     This study is a randomized, controlled study, with the primary objective to demonstrate~     non-inferiority of Hemopatch compared to TachoSil in postoperative air leak duration after~     pulmonary resection, and with the secondary objective of evaluating the safety of Hemopatch~     compared to TachoSil.~   "
8908|NCT03450252|"~     The main aim of this study is to assess the acute effects of a pacemaker on reducing~     abnormally high intracavity pressures in the hearts of patients with mid-cavity obstructive~     hypertrophic cardiomyopathy (HCM). During a 12-month period of double-blinded follow-up,~     descriptive data will be collected on patients symptomatic and physical performance during~     dichotomous pacemaker settings for 6-months each (active and back-up). The statistical~     information collected will be used to design a much larger research trial of patient benefit.~   "
8909|NCT03450239|"~     The investigators will examine compulsivity in those who have recovered from anorexia~     nervosa, using a multi-modal MRI study. The neural activation of key fronto-striatal areas~     will be explored using a task which examines set-shifting and reversal-learning, two key~     components of compulsivity. Additionally, the functional networks displayed during~     resting-state MRI will be examined between groups, as will the neurochemicals present (using~     Magnetic Resonance spectroscopy).~   "
8910|NCT03450226|"~     studies suggest that off-pump coronary artery bypass surgery is associated with improved~     outcomes when compared to on-pump coronary artery bypass. many studies have shown that~     off-pump coronary bypass surgery reduces patient morbidity and mortality.~      manipulation of the coronary arteries during cardiac surgery can stimulate the adjacent~     post-ganglionic sympathetic fibers and mimic stellate ganglion stimulation ,stellate ganglion~     block (SGB) can interrupt this reflex by decreasing the efferent cervical sympathetic~     outflows.~   "
8911|NCT03450213|"~     Keratoconus is a bilateral (but usually asymmetrical) non-inflammatory progressive thinning~     process of the cornea. It manifests as characteristic cone-like ectasia of the cornea~     associated with irregular stromal thinning, resulting in a cone-like bulge , which causing~     irregular astigmatism and vision impairment.~   "
8912|NCT03450200|"~     Diabetic Peripheral Neuropathy (DPN) is the common complication seen in the diabetic~     patients. Moreover, it will lead to another complication as disabilities and difficulties in~     activities of daily living (ADL). Most of the intervention for diabetes and diabetic~     neuropathic patients are mostly focusing on the prevention of foot ulcer. Diabetic foot care~     can prevent only for diabetes-related foot ulcer and foot amputation. It cannot be reduced~     DPN and cannot be improved the activities of daily living of the patient with DPN. Moreover,~     there is the restriction of weight-bearing exercise on the recommendation of exercises for~     the patients with DPN. Therefore, exercise program which may be suitable for all the patients~     with DPN was introduced in this study to improve ADL and decrease the neuropathic symptoms in~     the diabetic patients.~      Compliance with exercise or intervention is not only critical to get adherence but also for~     the long-term use of its. Easy to do exercise in the short duration which can able to do on~     their own in their home promote their compliance and adherence to the exercises. In this~     study, the effectiveness of exercises in the patients with diabetic peripheral neuropathy was~     examined to fulfill the requirement of exercises which is simple and can be done in a short~     time. The objective of the study is to examine the effectiveness of exercise in the patients~     with diabetic peripheral neuropathy.~      Randomise controlled trial was used in this study. Data collection was done at the outpatient~     diabetic clinic in North-Okkalapa General Hospital (NOGH), and University of Nursing, Yangon.~     The inclusion criteria for the participants were the patients receiving diabetic care at the~     out-patient-department of designated hospitals, able to contact via the telephone, presence~     of signs and symptoms of DPN, agreed to involve in the study (informed consent), and aged~     over 25 years. The persons who are suffering from DPN other than diabetes, severe illness of~     diabetic patients, diabetes with other comorbidities, amputation of hands and feet from any~     reasons, mental illness and alcoholism will be excluded from this study. By using a~     randomizing table, the patients who met the including criteria and had already examined the~     presence of DPN in the prevalence study of DPN were assigned intervention (n=61) and control~     group (n=60) and invited to participate in the second study. After getting informed consent,~     further assessment and examination were done on the day of data collection because some parts~     of data collection have already done in the prevalence study. Research assistants have~     trained all procedures including interviewing with the questionnaires and physical~     assessments. The instruments used in this study are Patient Neurotoxicity Questionnaire~     (PNQ), short-form McGill Pain Questionnaire (SF-MPQ), Behavioural Rating Scale and visual~     analog scale (0-100) as the standardized instruments in this study. Physical assessments were~     done for hand grip, pinch force, 10-g Semmes-Weinstein Monofilament (SWM) test, Timed Up and~     Go (TUG) test. A1cGEARs was used to check HbA1C level of the diabetic neuropathic patients.~     Finger counting time also recorded by using the stopwatch.~      The participants in the intervention group learned the exercise program by demonstration,~     using audio-visual aids. Hand and finger exercises and foot exercises were used as the~     intervention in this study. The intervention was developed by modifying some exercise for~     arthritis and other neuropathy. The permission to use some parts of their exercise has~     already got from the responsible person of the sources. The exercises lasted 10 minutes for~     all of the exercises completely. Health education about foot care was provided to the control~     group and the intervention group. The data collection points were before the intervention,~     immediately after the intervention (eight weeks), and follow-up eight weeks after the~     intervention.~      This study had already obtained ethical clearance from Nursing Science Ethical Review~     Committee, Graduate School of Health Sciences, Okayama University, Japan with the review~     number of D16-07, University of Nursing, Yangon, and Department of Medical Research (Lower~     Myanmar) with approval number Ethics/DMR/2017/048.~   "
8913|NCT03450187|"~     This is a phase 1, single-center, randomized, placebo-controlled, double-blind, multiple~     ascending-dose study to assess the safety, tolerability, and PK of oral TP-271 in healthy~     adult subjects. Male or female subjects aged 18 to 50 years who fulfill the~     inclusion/exclusion criteria will be enrolled in this study.~   "
8914|NCT03450174|"~     Multiple micro-nutrient deficiencies in Pakistan is wide spread, there is dire need to~     address these by using smart solutions, among them multiple fortified product (fudge) is an~     alternate possible way to address this issue. Fortified products have the potential to reduce~     micronutrient deficiencies in children, therefore in current study children from 3-5 years~     will receive fortified product along with enhance nutrition promotional information to bring~     change in their dietary practices and nutritional indices.~   "
8915|NCT03450161|"~     Randomized, double-blinded, three arm study in adult patients undergoing first time coronary~     artery bypass grafting (CABG) surgery with median sternotomy. The investigators will examine~     the effects of three fentanyl dosing schemes (high-dose bolus, low-dose bolus, continuous~     dose) on the area of hyperalgesia and allodynia at 24 and 48h as well as on persisting pain~     at 3, 6, and 12 months. Additionally, the investigators will measure fentanyl concentrations~     throughout anesthesia.~   "
8916|NCT03450148|"~     The purpose of this research study is to test a new way to help people quit smoking. The PI~     will test acceptability and feasibility of a new device called Pavlok wearable wrist band to~     help caregivers of pediatric patients with respiratory illness quit smoking. Participants~     will be caregiver of a child with respiratory illness and referred for Nicotine replacement~     therapy. Participants will be randomized into intervention and control groups.~   "
8917|NCT03450135|"~     The prevalence of adolescent depression is steadily rising in the U.S., especially among~     adolescent girls. Currently 20% of adolescent girls experience major depression compared with~     6% of boys (National Institute of Mental Health, 2016). The profound gender disparity in~     depression that emerges at puberty, but not before, implicates a role of ovarian steroid~     hormones in promoting affective (mood) symptoms in adolescent girls. In addition to dramatic~     physical maturation and a rapidly changing reproductive hormone environment at puberty,~     adolescence is also a time of exposure to substantial psychosocial stress, particularly in~     girls. It is well documented that stress interferes with the maturation of neurodevelopmental~     trajectories and is a critical precipitating factor in the pathway to psychopathology.~     However, the neuropathophysiological mechanisms linking stress exposure and sensitivity to~     ovarian hormone fluctuations at puberty to the onset and maintenance of depression symptoms~     in adolescence have yet to be elucidated, and is the purpose of this research.~   "
8918|NCT03450122|"~     The goal of this clinical research study is to learn if it is safe to give modified, or~     changed, T cells (called CD8+ NY-ESO-1T cells) alone or in combination with LV305 and CMB305~     to patients with sarcoma. Researchers also want to learn if this combination can help to~     control the disease.~      T cells are a natural type of immune cell. The changed T cells used in this study will be~     participant's own that can be changed in a laboratory and designed to kill some types of~     cancer cells.~      This is an investigational study. Modified T cell infusions are not commercially available or~     FDA approved. Additionally, neither LV305 nor CMB305 are FDA approved or commercially~     available. It is investigational to give the combination of modified T cell infusions, LV305,~     and CMB305 to sarcoma patients.~      The study doctor can explain how the study drugs are designed to work.~      Up to 18 participants will be enrolled in this study. All will take part at MD Anderson.~   "
8920|NCT03450096|"~     Randomised controlled prospective trial with 2 groups (active group with Lumbar plexus block~     (LPB)-catheter vs control group). In a randomized controlled trial, the investigators will~     investigate under controlled circumstances the effect of a LPB-catheter placed with~     ultrasound guided Shamrock-technique to improve postoperative pain treatment after~     unilateral open hip and femoral surgery in paediatric patients. The investigators will~     investigate the effect on opioid consumption and the reduction of opioid related side effects~     during the first 24 postoperative hours~   "
8921|NCT03450083|"~     Benralizumab will be used in a placebo controlled randomized study to treat severe chronic~     rhinosinusitis with nasal polyps~   "
8922|NCT03450057|"~     This study will evaluate the effects of Daratumumab with dexamethasone in subjects with~     relapsed or refractory multiple myeloma and renal impairment.~   "
8923|NCT03450044|"~     This study aims to evaluate for the first time in Colombia the immunogenicity and safety of~     autologous DCs as enhancers of the immune response in patients with ductal breast cancer who,~     prior to surgical resection of the tumor, will receive neo-adjuvant chemotherapy with~     Doxorubicin and Cyclophosphamide. concomitantly with the transfer of autologous DCs. This~     clinical trial is based on the concept proposed in countries like France more than a decade~     ago, that chemotherapy or radiotherapy cause the tumor cells to release certain signals that~     favor the activation of the immune system against cancer. Therefore, the combined use of~     chemotherapy with vaccination with dendritic cells would provide the immune system with~     greater antitumor response capacity, taking advantage of the release of said signals to~     initiate a series of processes that would be reflected in the activation of T lymphocytes~     capable of destroying the remaining cells of the tumor. To determine the specificity of the~     response evoked by the adoptive transfer of autologous DCs, in each patient the degree of~     recognition of the tumor by the immune system before and after said procedure will be~     evaluated. These results will be compared with those of patients who participated in a~     control group.~      Hypothesis Adoptive transfer of autologous DCs generated in vitro, in patients with stage~     IIA-IV breast cancer who receive neoadjuvant therapy with Doxorubicin and Cyclophosphamide,~     is a safe procedure that stimulates anti-tumor immune responses in treated patients.~      Principal aim:~      To evaluate the safety and immunogenicity of the use of DCs when used in patients with stage~     IIA-IV breast cancer in association with neo-adjuvant chemotherapy with~     Doxorubicin/Cyclophosphamide.~      Specific aims:~        -  Generate immuno-competent dendritic cells in conditions of Good Clinical Practice and~          Good Laboratory Practices.~        -  Determine in each patient the immunological status of specific T lymphocytes against~          tumor antigens, before and after chemotherapy, in order to demonstrate whether the~          adoptive transfer of DCs favors the anti-tumor immune response.~        -  Register in patients with breast cancer in neo-adjuvant chemotherapy the class and~          frequency of adverse effects that could be generated as a result of the adoptive~          transfer of autologous DCs.~   "
8924|NCT03450031|"~     This research aims to establish a panel of inflammatory biomarkers of the early (Histamine,~     Tryptase, ProstaglandineD2) and late (Interleukin-4, Interleukin-5, Interleukin-6,~     Interleukin-13, Eotaxin, Tumor necrosis factor-a (TNF), (Macrophage Inflammatory~     Protein-1beta (MIP1ß)) phase response to nasal bolus allergen challenge (NAC) in subjects~     with out-of-season seasonal allergic rhinitis, suitable for future application in drug~     intervention studies of novel anti-allergy therapeutics.~   "
8925|NCT03450018|"~     This is a multi-center, open-label Phase 1b study of SLC-0111 (oral) in combination with IV~     gemcitabine in CA IX positive subjects with mPDAC and comprises of 2 parts:~        -  Part 1: Dose Escalation~        -  Part 2: Dose Expansion~   "
8926|NCT03450005|"~     The objective of the European Confederation of Medical Mycology - ECMM Candida Registry~     (CandiReg) is to overcome the lack of knowledge on epidemiology, clinical course, and~     molecular characteristics of invasive infections due to invasive Candida infections and to~     function as a platform for future studies and in case of outbreaks.~   "
8927|NCT03449992|"~     This study analyzed the effects of 15 days of beetroot juice supplementation on different~     performance measures in elite Spanish distance runners~   "
8928|NCT03449979|"~     Purpose: Investigating the effects of non-invasive transcranial alternating current~     stimulation (tACS) on healthy participants and participants with mood disorders.~      Participants: 30 males and females, ages 18-65, with depressed mood; 30 healthy males and~     females, ages 18-65, free of neurological or psychiatric conditions.~      Procedures: This is a single visit study with two stimulation conditions (tACS and sham~     tACS). The session will begin with clinical assessments (behavioral inhibition and behavioral~     activation scales (BIS/BAS), the structured clinical interview for the DSM-5 (SCID), and the~     hamilton-depression rating scale 17 item (HDRS17)), followed by a 7 minute resting state EEG~     (2 minutes eyes closed, 5 minutes eyes open), followed by the stimulation session (40 minutes~     of tACS or sham tACS), followed by an additional 5 minute resting state EEG. An additional 10~     minutes of EEG will be collected following this 5 minute resting state (2 minutes segments,~     with 30 second breaks). The stimulation will involved 40 minutes of transcranial alternating~     current stimulation, 2mA in amplitude and 10 Hz frequency.~   "
8929|NCT03449966|"~     * single center, prospective study First, evaluate the lesion under the white light endoscopy~     (WLE) → IV fluorescein sodium 0.1mL/kg → evaluate the lesion under probe-based confocal laser~     microendoscopy → target biopsy under the pCLE → random biopsy under WLE~   "
8930|NCT03449953|"~     Hematologic malignancy patients are admitted to ICU in increasing numbers. Successful ICU~     intervention has led to an increasing number of ICU survivors; however, there is a lack of~     information available about these patients' long term survival and quality of life. There is~     little Canadian data regarding ICU survival and regarding 1-year survival and functional~     outcomes in this group of patients. Over 500 patients are admitted annually to Canadian ICUs~     with an underlying hematologic malignancy or stem cell transplant, yet there is a paucity of~     up to date long-term outcome data. This information will facilitate a better understanding~     who would best benefit from critical care interventions and the impact of critical illness on~     their level of function at 1 year as well as survival.~   "
8931|NCT03449940|"~     To prospectively compare erectile function at 12 months, utilizing the abbreviated~     International Index of Erectile Function-5 (IIEF-5) score, for men treated with an immediate~     repair versus a delayed repair.~   "
8932|NCT03449927|"~     The purpose of this pilot before and after interventional study is to determine if early~     intervention and provision of menus regarding appropriate diet choices for melphalan~     autologous transplant patients experiencing nausea and diarrhea will improve nutrition status~     and overall calorie and protein intake throughout the transplant process.~   "
8933|NCT03449914|"~     Management of older cancer patients is challenging, due to a lack of good quality evidence to~     guide treatment decisions, as well as the wide variability in the level of fitness for~     treatment of elderly patients. Oncologists are faced with the challenge of determining the~     most suitable treatment for an individual taking into account their comorbidities, competing~     causes of death, quality of life and functional reserve.~      Colorectal cancer (CRC) is the second leading cause of cancer-related deaths in the western~     world and ranks second among the most frequent malignancies in Europe in both men and women.~     The incidence and mortality of CRC strongly increases with age. Approximately 60% of new~     cases of CRC and 70% of CRC-related deaths occur in patients aged 65 years and older, with~     about 40% of patients aged 75 years or older.~      The oncologists' therapeutic decision-making for elderly patients with metastatic colorectal~     cancer (mCRC) has been largely debated in the last few years, mainly because of the lack of~     trial-based recommendations, due to the underrepresentation of patients more than 65 years~     old in clinical trials. As a consequence, therapeutic choices in this setting are frequently~     driven by data from retrospective, pooled and meta-analyses. These results do not necessarily~     reflect the general population affected with mCRC and are often limited by potential~     confounding factors.~      It is well recognized that chronological age is not an effective criterion on which to base~     therapeutic decisions. Rather, treatment tolerability in an older cancer patient is primarily~     related to physiological or biological age, that is the level of fitness, which takes into~     account factors such as functional status and comorbidities. Physiological age is better~     assessed with a comprehensive geriatric assessment (CGA), a multidisciplinary evaluation~     covering domains such as cognitive and mood status, functionality, comorbidities, and~     nutrition. These deficits are prevalent in older patients but which may be missed with~     routine evaluation.~      There is now strong evidence that use of a CGA assessment in a general geriatric patient~     population can improve health outcomes. While some form of geriatric assessment have been~     recommended by specialist advisory panels for all elderly patients in whom chemotherapy is~     considered, evidence of CGA leading to improved outcomes in a geriatric population with~     cancer is very limited. CGA for older patients with cancer does appear to provide information~     relating to prognosis, likelihood of toxicity from chemotherapy, and has been shown to~     influence treatment decisions. However, this approach is time-consuming, leading cancer~     specialists to seek an easier screening tool that can separate fit older patients with~     cancer, who are able to receive standard cancer treatment, from vulnerable patients that~     should subsequently receive a full assessment to guide tailoring of their treatment regimen.~      The G8 is a simple 8-items screening tool, developed specifically for older patients with~     cancer. This tool, addressed by the clinician, covers multiple domains, focusing on~     nutritional status, mobility, neuropsychological problems, medication use, self-rated health~     status and age. The G8 demonstrated a good sensitivity in identifying patients with~     impairments across multiple domains when a cut-off of 14 points is adopted. Patients with a~     score < 14 would be candidate to a CGA. Nevertheless, this cut-off showed poor specificity~     and negative predictive value. Furthermore, some evidences suggested that the G8 might be~     able to predict survival, while its predictive value for treatment-related toxicities has not~     been extensively explored.~      While literature data support a promising role for G8 as a simple cost-effective screening~     tool in elderly patients, to date its use in clinical practice is not widespread, and only~     selected centers with a focus in geriatric oncology routinely perform this assessment to~     enhance the baseline evaluation of patients before treatment choice.~      The lack of ''real life population'' data makes it difficult to evaluate the role of G8 in~     the setting of common practice in an unselected population and to prove its efficacy and~     reliability outside selected cases.~      Moreover, recent data suggest how a physical performance test, such as Timed Up and Go, could~     be a useful indicators of prognosis, functional decline and treatment-related complications.~      This study is designed to promote a comprehensive evaluation of elderly patients before~     treatment decisions and to prospectively evaluate the association of G8 assessment with~     clinical outcome and treatment-related severe toxicity in the real life population of elderly~     patients with colorectal cancer in Veneto. Additionally, preliminary data on feasibility and~     reliability of Timed Up and Go measurement as prognostic determinant and dynamic marker, will~     be collected.~   "
8959|NCT03449576|"~     Social difficulties are serious and frequent complicating factors in the treatment of~     post-traumatic stress disorder (PTSD). To better understand how treatment of post-traumatic~     stress disorder impacts neural mechanisms of social cognition, the investigators are~     examining behavior and brain processes associated with response to Trauma Management Therapy.~     Understanding the behavioral and neural impact of psychotherapy may contribute to development~     of more effective treatments for PTSD.~   "
15155|NCT03368534|"~     The purpose of the study is to provide a more effective method of harvesting skin with~     minimal or no pain, heal more rapidly with little scarring in an outpatient setting with the~     use of only local anesthesia.~   "
8934|NCT03449901|"~     The investigators have recently demonstrated that argininosuccinate synthase 1 (ASS1)~     expression is silenced in 88% of all sarcomas (n=708), and that this loss is associated with~     a decreased overall survival. Using the extracellular arginine depleting enzyme PEGylated~     arginine deiminase (ADI-PEG20), an extracellular arginine depleting enzyme, the investigators~     demonstrated ADI-PEG20 induces a prosurvival metabolic reprogramming in ASS1-deficient~     sarcomas that redirects glucose into the serine/folate pathway directing the carbons from~     glucose into pyrimidine biosynthesis, thus sensitizing cells to death by the pyrimidine~     antimetabolite gemcitabine by using metabolomics. The synthetic lethality was increased by~     the addition of docetaxel. Therefore a phase II clinical trial of ADI with gemcitabine and~     docetaxel, a standard second line therapy for soft tissue sarcoma will be conducted to~     determine if the clinical benefit rate of gemcitabine and docetaxel is improved by the~     metabolic changes induced by ADI-PEG20~   "
8935|NCT03449888|"~     This is a 5-year clinical trial to evaluate whether arm exercise electrocardiographic (ECG)~     stress testing without or with coronary artery calcium scoring (-/+ CAC) is non-inferior to~     treadmill ECG stress testing -/+ CAC and pharmacologic myocardial perfusion imaging as an~     initial evaluation to detect obstructive coronary artery disease, determined by cardiac~     computed tomographic angiography (CTA) and to predict clinical outcome, defined by a primary~     clinical endpoint of the composite of cardiovascular (CV) mortality, myocardial infarction,~     and 90-day post-stress test coronary artery revascularization and secondary clinical~     endpoints of all-cause mortality and CV mortality.~   "
8936|NCT03449875|"~     Patients with abdominal aortic aneurysms (AAA) suitable for endovascular aortic repair (EVAR)~     with Treovance were eligible to participate. Main inclusion criteria were: age 18-85 years;~     infrarenal AAA without significant infrarenal or distal iliac landing neck calcification or~     thrombus formation; infrarenal or distal iliac landing neck size requirements specified in~     the instructions for use. Main exclusion criteria: dissection/ruptured aneurysm or prior AAA~     endovascular or surgical repair. The primary endpoints were standard EVAR criteria.~   "
8937|NCT03449862|"~     The frequency of head computed tomography (CT) imaging for mild head trauma patients has~     raised safety and cost concerns. Validated clinical decision rules exist in the published~     literature and on-line sources to guide medical image ordering but are often not used by~     emergency department (ED) clinicians. Using simulation, we explored whether the presentation~     of a clinical decision rule (i.e. Canadian CT Head Rule - CCHR), findings from malpractice~     cases related to clinicians not ordering CT imaging in mild head trauma cases, and estimated~     patient out-of-pocket cost might influence clinician brain CT ordering. Understanding what~     type and how information may influence clinical decision making in the ordering advanced~     medical imaging is important in shaping the optimal design and implementation of related~     clinical decision support systems.~   "
8938|NCT03449849|"~     The primary objective of this study is to determine how daily consumption of kale changes the~     activity of human xenobiotic metabolizing enzymes. Secondary objectives are to measure~     absorption and metabolism of kale phytonutrients, and to determine how kale consumption~     affects gene expression related to metabolism and lipid measures associated with~     cardiovascular health.~   "
8939|NCT03449836|"~     Allergic rhinoconjunctivitis is a pathology of the nasal and conjunctival mucosa induced by~     Immunoglobulin E (IgE) mediated inflammation following allergic exposure. This condition~     represents a global health problem that affects 5 to 20% of the population. As with all~     allergic diseases, its prevalence in pediatric age has increased over the last 30 years, as~     shown by the results of the international epidemiological study International Study of Asthma~     and Allergies in Childhood (ISAAC) which shows that the overall prevalence is 8.5 % in~     children aged 6-7 and 14.6% in children aged 13-14. In Italy, on average, the prevalence~     stands at 17.6% in the 6-7 year age range and 31.3% in the 13-14 age range, demonstrating a~     growing trend. The allergic rhinoconjunctivitis undiagnosed and / or not treated properly can~     negatively affect the school activities and in general the quality of life of children and~     their parents, as well as having important socio-economic repercussions in terms of medical~     expenses, school absences and days of work lost by parents. Furthermore, the lack of~     therapeutic intervention can lead to an increased risk of complications in the medium and~     long term. Recent advances in the understanding of the mechanisms underlying the inflammation~     of the airways have led to an improvement of the therapeutic strategies for the management of~     allergic rhinoconjunctivitis: the four cornerstones of the approach to this pathology~     promoted by the European Academy of Allergy and Clinical Immunology (EAACI) include allergen~     removal, patient education, pharmacotherapy and specific immunotherapy. However, there is~     discordant evidence to support their efficacy in reducing the symptomatology of allergic~     rhinoconjunctivitis, with the need to resort to the invasive surgical approach in several~     cases. Therefore, the use of probiotics, defined as live micro-organisms which, when~     administered in adequate quantities, confer an advantage for the organism can be useful. The~     mechanisms by which probiotics or their components, for example DNA, proteins and peptides,~     exert such beneficial effects concern the regulation of the immune system, the antagonist~     action against potentially pathogenic microorganisms and the quantitative and qualitative~     modulation of the intestinal microbiota. In fact, recent clinical studies have demonstrated~     the protective effect of infections of the high respiratory tract in adults and recurrent~     average otitis in pediatric age of the Streptococcus salivarius 24SMBc and Streptococcus~     oralis 89a strains administered through nasal spray. These well-characterized probiotics were~     safe, tolerated and able to positively modulate the composition of the respiratory epithelial~     microbiota and the function of the immune system.~   "
8940|NCT03449823|"~     Twin-twin transfusion syndrome (TTTS) is a complication affecting 10-15% of monochorionic,~     diamniotic (MCDA) twin pregnancies. Unevenly distributed blood flow across a shared placental~     circulation results in a volume-restricted donor twin and a volume-overloaded recipient twin,~     and TTTS has high perinatal morbidity and mortality without treatment.~      Differential donor and recipient findings in TTTS can be observed upon ultrasound evaluation.~     TTTS is classified according to the Quintero staging system, which evaluates amniotic fluid~     volumes, fetal bladders, Doppler study of the umbilical artery and ductus venosus, and for~     the presence of hydrops or death. However, due to seemingly complex and variable disease~     pathophysiology, the Quintero system cannot predict outcomes on a case-by-case basis.~      Prior studies have associated fetal renal artery Doppler ultrasound measurements with~     amniotic fluid volume in singleton pregnancies. In fetuses with placental insufficiency,~     adaptive circulatory changes maintain adequate oxygen delivery to vital organs such as the~     heart, brain, and adrenals, with a consequent deprivation to splanchnic organs. In the fetal~     kidney, as vascular resistance increases during hypoxia, renal perfusion decreases~     proportionately. These changes are reflected in renal artery Doppler findings. As these same~     adaptations are believed to occur in donor twins, renal artery Doppler studies may also be of~     value in the TTTS evaluation.~      This study plans to perform renal artery Doppler assessments in MCDA twins complicated by~     TTTS, and compare them to measurements in gestational-age equivalent MCDA twins without TTTS.~     If findings differ significantly, it would support further investigation into the use of~     renal artery Doppler studies for the evaluation of complicated MCDA twins.~   "
8941|NCT03449810|"~     Low back pain is the most common health problem that affects work performance and quality of~     life. It's defined as pain, stiffness and discomfort experienced in the area lying on the~     posterior aspect of the body from the lower margin of the twelfth rib to the lower gluteal~     folds that could be referred into one or both lower limbs lasting for at least 1 day. LBP may~     be classified by duration as acute (pain less than 6 weeks), sub-acute (6 to 12 weeks), or~     chronic (more than 12 weeks) or by the underlying cause (non-mechanical or mechanical).~     Mechanical low back pain (MLBP) or Unspecified is deﬁned as low back pain not attributable to~     recognizable, known speciﬁc pathology. It is the leading cause of disability amongst the~     major musculoskeletal conditions which leads to Impairments, Activity limitations and~     Participation restrictions. Therefore it becomes a psychosocial/economic burden on~     individuals, families, communities, industries and government. Existing literature shows~     globally 40% to 50% of people have LBP at some point in their lives and there exists a~     challenge in Africa on the best rehabilitation methods for low back pain which could prevent~     chronic pain and disability as evident in a literature. The aim of the study is to understand~     the profile of the MLBP in Jigawa state Northwest Nigeria, in order to test the effectiveness~     of Muscles Energy Technique intervention as an appropriate procedure that can influence~     spinal instability, relieve pain, decrease functional disability, improve Quality of life~     (QoL), Activity limitation and Participation restrictions. The study intends to use recent~     advance techniques in measuring outcomes variable of Physiotherapy research like~     Electromyography machine to establish an empirical evidence on the effectiveness of the study~     interventions in Patients with CMLBP.~   "
8942|NCT03449797|"~     Background: Adrenal vein sampling (AVS) is the gold standard test for the subtyping of~     primary aldosteronism (PA). This procedure is hampered by unsuccessful bilateral cannulation~     of adrenal veins, which can occur in up to two thirds of the cases depending on the cutoff of~     the selectivity index used. The rapid intra-procedural cortisol assay (IRCA) can increase the~     rate of bilateral success of AVS. This can be proven using a randomized prospective study~     design approach.~      Aim: We will therefore evaluate if an IRCA-guided AVS strategy can increase the rate of~     selectivity and thus the success rate of adrenal vein catheterization.~      Methods: Consecutive patients with a biochemical diagnosis of PA, seeking surgical cure, will~     be randomized to undergo AVS according to an IRCA-sham or an IRCA-guided procedure.~      Experimental and endpoint will be the rate of bilaterally selective AVS studies as defined by~     a selective index cutoff > 2.00 value under baseline (unstimulated) conditions. With 100~     patients submitted to AVS with a normal procedure and 100 patients undergoing AVS with IRCA,~     it has been estimated that the study has 82% power to detect a significant difference of 18%~     at a two-sided 0.05 significance level between arms.~      Expected results. Given this power we expect to the able to determine if IRCA is useful or~     not for improving the success rate of AVS. Given the current disastrous situation regarding~     the clinical use of AVS this will be a major accomplishment in the field of the subtyping of~     PA.~   "
8943|NCT03449784|"~     Cardiovascular disease (CVD) due to atherosclerosis of the arterial vessel wall and to~     thrombosis is the foremost cause of premature mortality and of disability-adjusted life years~     in Europe, and is also increasingly common in developing countries. In the European Union,~     the economic cost of CVD represents annually €192 billion in direct and indirect healthcare~     costs. The main clinical entities are coronary artery disease (CAD), ischaemic stroke, and~     peripheral arterial disease (PAD). The causes of these CVDs are multifactorial. Some of these~     factors relate to lifestyles, such as tobacco smoking, lack of physical activity, and dietary~     habits, and are thus modifiable. Other risk factors are also modifiable, such as elevated~     blood pressure, type 2 diabetes, and dyslipidaemias, or non-modifiable, such as age and male~     gender. LDL-cholesterol (LDL-C) is one of the major risk factors for CVD, through its role in~     the development of atherosclerosis. The efficacy of statins has been demonstrated by a~     considerable amount of literature not only in lowering LDL cholesterol levels but also in~     reducing cardiovascular events, both in diabetes and non-diabetes patients. Guidelines for~     the management of dyslipidemia have emerged from different countries. Thereby, in 2016 the~     French Society of Endocrinology (SFE) and the New French Society of Atherosclerosis (NSFA)~     published a consensus statement on the management of dyslipidemias integrating features from~     European recommendations and in 2017 the Haute Autorité de Santé updated the French~     guidelines. However, LDL-C goal attainment has rarely been assessed specifically in diabetes~     population, in which CVD is of particular importance. This study aimed to assess the rate of~     dyslipidaemias in a population of patient hospitalized in Endocrinology-Diabetology-Nutrition~     unit.~      This observational study was carried in the Diabetes-Nutrition unit of the University~     Hospital of Montpellier - France. All consecutive patients admitted to that unit during the~     study period were assessed for eligibility. Data on age, sex, tobacco smoking, body mass~     index, hypertension (treatment of previously diagnosed hypertension or blood values > 140/90~     mmHg), presence and type of CVD (coronary artery disease, stroke and transient ischemic~     attack, peripheral arterial disease), were collected at admission. LDL-C, HDL-C and~     triglycerides levels calculated with the Friedewald formula, and glomerular filtration rate~     calculated according to the CKD-EPI formula were obtained from blood samples taken within 24~     hours of hospitalization admission. Information on the name and daily dose of lipid lowering~     drugs (statins, fibrate, ezetimibe …) at admission was documented. Cardiovascular risk level~     and LDL-C target values were defined according to 2011 and 2016 ESC guidelines and 2017~     French guidelines.~   "
8944|NCT03449771|"~     HIV pre-exposure prophylaxis (PrEP) with Truvada®, a combination of two antiretrovirals~     (tenofovir & emtricitabine) is a prevention strategy for HIV-negative people at high risk of~     acquiring HIV. PrEP has thus been integrated as a new tool to significantly reduce the risk~     of HIV infection, especially among men who have sex with men (MSM). Since its introduction,~     an increase in sexually transmitted infections (STIs) has been observed, particularly in~     relation to the use of psychoactive substances in a sexual context (Chemsex).~      In this context, the description and evaluation of these practices seem necessary, as well as~     the impact on the risk of addiction and mental health.~   "
8945|NCT03449758|"~     Primary Objective:~      To assess the effect of sarilumab in combination with conventional synthetic~     Disease-Modifying Anti-Rheumatic Drug (csDMARD) and/or monotherapy on patient-reported impact~     of disease, using the rheumatoid arthritis impact of disease (RAID) questionnaire, in~     patients with active rheumatoid arthritis (RA) and inadequate response or intolerance to~     current csDMARD or tumor necrosis factor (TNF) inhibitors.~      Secondary Objectives:~        -  To assess the change of the RAID score in patients treated with sarilumab in combination~          with csDMARD and/or monotherapy.~        -  To assess the effect of sarilumab in combination with csDMARD and/or monotherapy on~          other patient-reported outcomes (global assessment of disease activity, disability,~          morning stiffness, fatigue, anxiety/ depression, mood disorders, and physical~          activities).~        -  To assess the efficacy of sarilumab in combination with csDMARD and/or monotherapy using~          DAS28-ESR and clinical disease activity index (CDAI).~        -  To assess the safety of sarilumab in combination with csDMARD and/or monotherapy.~   "
8946|NCT03449745|"~     This project aim at deciphering immune mechanisms that allow the immunoescape of AML~     initiating cells.~   "
8948|NCT03449719|"~     Metastatic castration resistant prostate cancer causes approximately 258400 deaths annually~     worldwide.~      In the presence of metastatic disease, systemic treatment remains the main clinical option.~     However, since the introduction of highly sensitive imaging techniques, a new clinical entity~     of metastatic patients with a limited number of lesions has been defined: oligometastatic~     patients.~      Although a clear benefit has yet to be demonstrated in this group of patients, the use of~     stereotactic body radiotherapy (SBRT) or other local therapies directed against all active~     lesions has been suggested as a possible salvage treatment.~      Irradiation of metastatic foci may delay the emergence of castration resistance because~     irradiation is effective against both ADT¬ sensitive and ADT ¬resistant prostate cancer cells~     as shown in re-biopsy studies. Stereotactic body radiation therapy has been used in this~     setting to defer the initiation of ADT in patients with oligometastatic prostate cancer with~     notable results.~      Abiraterone acetate is a first class inhibitor of cytochrome P ¬450c17, a critical enzyme in~     extragonadal and testicular androgen synthesis. Abiraterone plus low dose prednisone improves~     survival in patients with metastatic castration ¬resistant prostate cancer who have already~     received docetaxel and the combination therapy has received regulatory approval for this~     indication. Furthermore, Abiraterone acetate is approved also in patients who did not undergo~     to docetaxel chemotherapy, after the results from the COU-AA 302 study; Results from this~     phase III trial confirmed the benefit in chemo-naïve patients treated with abiraterone~     acetate both in terms of overall and radiological progression free survival, if compared to~     placebo.~      In oligometastatic CRPC, the rationale to use SBRT is that the addition of a local ablative~     treatment could improve disease control in mCRPC patients treated with a systemic therapy.~      The current phase II randomized trial,Ablative Radiation Therapy in patients with~     Oligometastatic castration resistant prostate cancer (ARTO trial) aims to evaluate the~     difference in PSA response rate between the experimental arm (AA+SBRT) and control arm (AA)~     in metastatic castration-resistant prostate cancer patients~   "
8949|NCT03449706|"~     In this prospective longitudinal study we aim to assess how immunologic and viral aspects of~     the human immunodeficiency virus (HIV) viral reservoir, established during early HIV~     infection and responsible for viral rebound at treatment interruption, evolve in individuals~     who start combination anti-retroviral therapy (cART) during acute seroconversion.~      Recently infected patients will be selected based on Fiebig staging for an in depth sampling~     protocol at different timepoints during a 2 year follow up period. Colonbiopsies, lymphnode~     resection, lumbar puncture, leucapheresis and repeated peripheral venous blood-draws will be~     performed. Immunological, virological and genome expression analysis will be performed on the~     gathered samples.~   "
8950|NCT03449693|"~     Clinical Trial. Open label. Parallel Groups. The purpose of the study is to determine the~     efficacy of oral supplementation with magnesium oxide to reduce febrile neutropenia episodes~     in pediatric oncology patients treated with cisplatin-based chemotherapy.~   "
8951|NCT03449680|"~     Hip arthroscopy surgery can be associated with significant pain. A regional anesthesia~     technique, the femoral articular branch block (FAB), has recently been proposed to~     collectively block terminal femoral and accessory obturator nerve branches to the hip joint~     with a single injection, theoretically blocking most of the innervation relevant to hip~     arthroscopy while sparing the main femoral nerve branches to the quadriceps muscles. The~     investigators aim to demonstrate the analgesic benefits of FAB. The investigators hypothesize~     that FAB will reduce opioid consumption and improve postoperative quality of recovery in~     patients having hip arthroscopy. This is a randomized, controlled, double-blind study and~     half the patients will be randomized to receive the femoral articular branch block and the~     other half of patients will be randomized to receive a placebo block. A comparison of pain~     will be made between both groups.~   "
8952|NCT03449667|"~     When a limb is severed, pain perceived in the part of the body that no longer exists often~     develops and is called phantom limb pain. Unfortunately, phantom pain goes away in only 16%~     of afflicted individuals, and there is currently no reliable definitive treatment. The exact~     reason that phantom limb pain occurs is unclear, but when a nerve is cut-as happens with an~     amputation-changes occur in the brain and spinal cord that actually increase with worsening~     phantom pain. These abnormal changes may often be corrected by putting local~     anesthetic-called a nerve block-on the injured nerve, effectively keeping any bad signals~     from reaching the brain with a simultaneous resolution of the phantom limb pain. However,~     when the nerve block resolves after a few hours, the phantom pain returns. But, this~     demonstrates that the brain abnormalities-and phantom pain-that occur with an amputation are~     not necessarily fixed, and may be dependent upon the bad signals being sent from the~     injured nerve(s), suggesting that a very long peripheral nerve block-lasting many months~     rather than hours-may permanently reverse the abnormal changes in the brain, and provide~     definitive relief from phantom pain. A prolonged nerve block lasting a few months may be~     provided by freezing the nerve using a process called cryoneurolysis. The ultimate~     objective of the proposed research study is to determine if cryoanalgesia is an effective~     treatment for intractable post-amputation phantom limb pain. The proposed research study will~     include subjects with an existing lower extremity amputation who experience intractable daily~     phantom limb pain. A single ultrasound-guided treatment of cryoneurolysis (or sham~     block-determined randomly like a flip of a coin) will be applied to the target nerve(s)~     involved with the phantom pain. Although not required, each subject may return four months~     later for the alternative treatment (if the first treatment is sham, then the second~     treatment would be cryoneurolysis) so that all participants have the option of receiving the~     active treatment. Subjects will be followed for a total of 12 months with data collected by~     telephone.~   "
8953|NCT03449654|"~     The objective of this study is to evaluate the mechanism behind the anti-atherogenic effects~     of liraglutide.~      In a randomized, placebo-controlled, double-blind, parallel trial we will included 100~     patients with type 2 diabetes. Patients will be randomized 1:1 to an active treatment period~     of 26 weeks or placebo for 26 weeks.~      The primary endpoint is change from baseline to week 26 in vascular inflammation, assessed by~     Flour Deoxy Glucose (FDG)-Positron Emission Tomography/Computed Tomography (PET/CT)~   "
8954|NCT03449641|"~     The role of different levels of compliance and long-term effects of positive airway pressure~     (PAP) therapy on gas exchange, sleepiness, quality of life, depression and death rate in~     patients with obesity hypoventilation syndrome (OHS).~   "
8955|NCT03449628|"~     To assess the effect of L. casei DG® (Lactobacillus paracasei CNCMI1572; Enterolactis® plus)~     on abdominal symptoms and gut microbiota metabolism/composition in non constipated patients~     with IBS (Irritable Bowel Syndrome). Patients will be randomized to receive L. casei DG®~     capsules, b.i.d. for 12 weeks the a 4 weeks Follow Up period will follow.~   "
8956|NCT03449615|"~     This study has been designed to validate a non-radioactive method to identify the sentinel~     lymph node using a superparamagnetic iron-oxide (SPIO) tracer respect to the traditional~     isotopic method. Both methods are used in every included patient and each patient is its own~     control.~   "
8957|NCT03449602|"~     Consecutive patients who are planned to undergo a medical thoracoscopy for obtaining pleural~     biopsies will be enrolled in the study.~      One hundred subjects will be randomized in 1:1 ratio to undergo thoracoscopy to the following~     groups:~      Group A (mini-thoracoscopy) Group B (Conventional rigid thoracoscopy) Primary outcome: (a)~     diagnostic sensitivity of mini-thoracoscopy and conventional rigid thoracoscopy in the~     diagnosis of exudative pleural effusions~   "
8958|NCT03449589|"~     Primary aim: examine a possible connection between cigarette smoking, disease activity and~     perceived pain in patients with rheumatoid arthritis.~      Secondary aim: Evaluate cardiovascular risk in patients with rheumatoid arthritis.~   "
11712|NCT03413514|"~     The purpose of the study is to evaluate the maximal cycle of effective neoadjuvant~     chemotherapy for resectable gastric cancer, to determine what is the best cycle of~     neoadjuvant chemotherapy for the patients who receive neoadjuvant chemotherapy.~   "
8960|NCT03449563|"~     The study was aimed to assess the effects of open thoracic paravertebral block on~     postoperative analgesia in patients undergoing open pulmonary lobectomy under general~     anesthesia. Then, A total of 90 patients with American Society of Anesthesiologists (ASA)~     scores of Ⅰ or Ⅱ, scheduled for open pulmonary lobectomy under propofol - remifentanil total~     intravenous anaesthesia, were randomly divided into PCIA group (group G), Ultrasound-guided~     TPVB combined with PCIA group (group U), and open TPVB combined with PCIA group (group~     E).Finally, the study find that Open TPVB can provided satisfactory analgesia for patients~     undergoing open pulmonary lobectomy under general anesthesia, and the analgesia efficacy was~     equivalent to the TPVB under ultrasound guidance,which should be popularized.~   "
8961|NCT03449550|"~     To assess the diagnostic validity and cost-effectiveness of a home respiratory polygraphy~     (HRP) performed at home compared with the standard polysomnography (PSG) in children with~     clinically suspected Obstructive Sleep Apnea (OSA).~   "
8962|NCT03449537|"~     Cow's milk allergy (CMA) affects up to 3% of European children. In the absence of an~     alternative to cow's milk, the management of CMA is based on the use of safe, affordable and~     nutritionally adequate formulas. In Scientific Societies Guidelines, extensively hydrolyzed~     casein formula (EHCF) is considered as safe first line approach for the treatment of children~     with CMA, whereas amino acid-based formula (AAF) is considered as second line strategy in~     children reacting to EHCF or as first line approach in children with CMA-induced anaphylaxis.~      Few and not recent studies, involving a poorly characterized study population, suggested that~     up to 10% of CMA children could react to the extensively hydrolysed formulas.~      It has been demonstrated that EHCF supplemented with L.rhamnosus GG (LGG) maintains~     hypoallergenic status and that is able to accelerate oral tolerance acquisition in children~     with CMA comparing with other formulas.~      The purpose of this study is to investigate the feasibility of a step-down approach in~     children affected by Immunoglobulin E (IgE)-mediated CMA with the aim to evaluate the effects~     of EHCF + LGG on oral tolerance acquisition and on immune response and gut microbiota~     shaping.~   "
8963|NCT03449524|"~     This is a multicenter double-blind, placebo-controlled study to evaluate the safety, efficacy~     and pharmacokinetics of 2 doses of CXA-10 on stable background therapy in 96 subjects 18 to~     80 years of age with PAH.~   "
8964|NCT03449511|"~     The purpose of this clinical trial is to determine the feasibility and effectiveness of~     aromatherapy in relief of commonly reported symptoms in cancer patients undergoing~     chemotherapy. Aromatherapy is a noninvasive, minimal risk intervention that could potentially~     alleviate the severity of treatment-related symptoms. This study will evaluate the ability of~     four aromatherapy scents (ginger, lavender, orange, jojoba) to reduce the severity of seven~     chemotherapy-induced symptoms (nausea, vomiting, pain, anxiety/distress, fatigue, sleep~     difficulties, and lack of appetite). Jojoba oil is a  carrier oil and will act as a placebo~     comparator in this study. Jojoba oil is present in small amount (1 drop) in the ginger,~     lavender, and orange aromatherapy inhalers. As part of the study, the participants will be~     asked to use an aromatherapy inhaler, which resembles a lipstick container, during three~     chemotherapy cycles. The participants will use the aromatherapy inhaler for 7 consecutive~     days. The investigators will ask the participants questions regarding demographics, clinical~     information, current severity of symptoms, and current methods of symptom management. There~     is a non-intervention baseline cycle during which subjects rate the severity of the seven~     different symptoms from 0 to 10 for seven consecutive days during their first chemotherapy~     study cycle. The next two study cycles are intervention cycles using the randomized~     aromatherapy. The participants will rate the severity of seven different symptoms from 0 to~     10 each day the aromatherapy inhaler during each of the three chemotherapy cycles (i.e., 7~     consecutive days during each chemotherapy cycle). At the end of the study, the participants~     will be asked about his/her satisfaction with the aromatherapy used during the study. All of~     these measurements will provide a better understanding of the effectiveness of aromatherapy~     for symptom management.~   "
8965|NCT03449498|"~     Research on the effects of physiotherapeutic interventions in children with CP has grown~     expansively, and shows a wide diversity of techniques and concepts that are used in variable~     intensity. Until now there is no consensus on the optimal intensity of these interventions to~     have a positive impact on the activity and participation level of these children. A recent~     systematic review and meta-analysis already showed evidence for the effect of intensive~     training of hand function in children with CP, including short bursts of highly intensive~     therapy. In contrast, studies on the effect of intensive therapy of gross motor function were~     limited, and training was performed at a lower intensity during a longer period, resulting in~     effects that are more inconclusive. Moreover, none of the reviewed studies included~     improvement of trunk control as one of their treatment goals, although it is known that most~     children with CP experience some problems with trunk control, to a variable extent.~      This research project has two aims, i.e. 1) investigating the effect of intensive therapy~     camps on qualitative and quantitative parameters of lower limbs and trunk; and 2) comparing~     the effect of two therapeutic approaches, namely a functional approach versus a more~     qualitative-functional approach on these parameters.~   "
8966|NCT03449485|"~     Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the~     pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the~     pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery.~     Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological~     availability of medication. In this study we investigate the pharmacokinetic effects of~     bariatric surgery on chlorprothixene.~   "
8967|NCT03449472|"~     Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the~     pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the~     pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery.~     Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological~     availability of medication. In this study the pharmacokinetic effects of bariatric surgery on~     quetiapine are investigated.~   "
8968|NCT03449459|"~     The colonization of potential pathogenic bacteria in lower respiratory tract is thought to be~     accountable for acute exacerbation in subjects with moderate to severe COPD. However, there~     is no accepted therapy for patients with COPD to remove the colonized bacteria in lower~     respiratory tract. Therefore, we plan to perform a multi-center, randomized, controlled trial~     to study the efficacy and safety of oral probiotics, aerosol inhaled amikacin or combined~     vaccination to decolonize bacteria in lower respiratory tract and prevent acute exacerbation~     of COPD.~   "
8969|NCT03449446|"~     The primary objectives of this study are:~        -  To assess the safety and tolerability of selonsertib (SEL), GS-0976, and GS-9674,~          administered alone or in combination, in participants with bridging fibrosis or~          compensated cirrhosis due to Nonalcoholic Steatohepatitis (NASH)~        -  To evaluate changes in liver fibrosis, without worsening of NASH~   "
16388|NCT03352453|"~     The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) of~     Rapastinel, compared to placebo in adult patients with major depressive disorder (MDD) who~     are at imminent risk of suicide.~   "
8970|NCT03449433|"~     Two forms of insulin lispro (LY900014 and Humalog®) and two forms of insulin aspart~     (NovoRapid® and Fiasp®) will be given to trial participants with diabetes mellitus type 1 by~     injection under the skin. The study will assess how fast the active ingredient (insulin~     lispro or insulin aspart) gets into the blood stream and how long it takes the body to remove~     it. A test meal will be given to trial participants to assess the course of the blood sugar~     lowering effect of the investigational products. The safety and tolerability of LY900014 will~     also be assessed. Screening is required within 14 days prior to the lead in. For each~     participant, the study will last up to 91 days.~   "
8971|NCT03449420|"~     The aim of the study is to determine if thromboelastography parameters can be predictive of~     severe post partum hemorrhage.~   "
8972|NCT03449407|"~     Auditory verbal hallucinations (AVH) are commonly reported as source of distress, disability~     and mortality in schizophrenia. Despite proven efficacy of antipsychotics, many patients~     still experience drug-refractory AVH. It has been postulated that AVH is maintained by~     negative emotions. Yet, little is known about the temporal relationship and underlying~     mechanisms between negative affect and AVH. Utilizing both an ecologically-validated method~     and brain imaging technique, this study aims to uncover the role of emotions in the~     maintenance of psychotic symptoms.~   "
8973|NCT03449394|"~     Psychological studies have shown that individuals tend to attribute causes of positive and~     negative events differently. Specifically, individuals hold an internalising or externalising~     bias of attribution which, in the case of particular patient groups, was found to polarize to~     the extreme. Such extreme attributional styles have found to have a direct impact on~     emotions, leading to a waning course of psychiatric disorders. This project aims to further~     examine the theoretical links between attributions and emotions using a transdiagnostic~     approach, and the effect of a 4-session process-based intervention on attributional biases.~   "
8974|NCT03449381|"~     Phase Ia - The main objective of the dose-escalation part of the trial is to determine the~     maximum tolerated dose (MTD), based on the frequency of patients experiencing dose limiting~     toxicities (DLT) during the first treatment cycle, and the recommended dose for expansion~     (RDE) of BI 907828 monotherapy, and to evaluate its safety and tolerability, by monitoring~     the occurrence and severity of adverse events (AEs), in two different schedules (Arm A with~     one single dose every 21 days, Arm B with one single dose on Days 1 and 8, every 28 days).~      The secondary objectives are the determination of the pharmacokinetic (PK) profile of BI~     907828 monotherapy, and the preliminary assessment of anti-tumor activity in patients with~     advanced or metastatic solid tumors.~      Phase Ib - In the expansion cohorts of the trial, the main objectives are to assess efficacy,~     and to further assess the safety, and PK profiles at the RDE, and determine the recommended~     Phase 2 dose (RP2D).~   "
8975|NCT03449368|"~     Observational study looking at the burden of illness in achondroplasia subjects aged 5-70.~     The study will include a 5 year review of historical clinical data as well as a single point~     collection of questionnaire data to look at the impact on the following in individuals with~     achondroplasia versus a normative population:~        -  Quality of life~        -  Clinical burden~        -  Healthcare resource use~        -  Socio-economic burden~        -  Psychosocial burden~      Up to 300 subjects will be included in sites in Germany, Spain, Italy, Sweden and Denmark~   "
8976|NCT03449355|"~     Pregnancy and delivery usually affect the general women's quality of life. Some studies have~     reported that sexual health may be affected by the mode of delivery. More than 70% of~     pregnant women prefer C-section due to several reasons point out the fear of pain and~     complications of vaginal delivery as the most common reasons.~      Aim of the work: To explore the relationship between quality of life and the possible sexual~     dysfunction after normal vaginal in comparison to cesarean section deliveries.~   "
8977|NCT03449342|"~     This study will test the well-known medicine turoctocog alfa for any side effects. The~     purpose is to test turoctocog alfa for any side effects in the Indian population. The~     participants will get turoctocog alfa. Turoctocog alfa is already a well-known medicine in~     India, and can be prescribed by the study doctor. The participants will get an injection~     every second day or 3 times per week. This is decided by the study doctor. The study doctor~     will decide the amount and how often the participants must take the medicine. The study will~     last for about 16 weeks. The participants will have 5 visits with the study doctor. If the~     participants agree to participate in this study, the participants will receive the first~     injection at the second visit, thereafter the participants will be trained to do the~     injection by themself.~   "
8978|NCT03449329|"~     Rationale Video Assisted Thoracic Surgery (VATS) is known to be a moderate painful procedure.~     There are many ways to manage postoperative pain following this kind of surgery. One of the~     'golden standards' nowadays is epidural analgesia using Patient Controlled Epidural Analgesia~     (PCEA). Patient Controlled Intravenous Analgesia (PCIA) is also an option, as are several~     kinds of regional anesthesia. One of the most recent described regional blocks is the~     Serratus Anterior Plane block (SAP), also called Serratus Intercostal Plane (SIP) block.~      Objectives The objective of this study is to evaluate the efficacy and opioid sparing effect~     of a SIP block in postoperative pain relief after VATS.~      Hypotheses Patients receiving a SIP block prior to surgery need less opioids during and 24h~     after VATS compared with patients who didn't receive a SIP block.~      Study design Single center randomized controlled trial Study population Patients older than~     18 years old scheduled for VATS. Main study parameters/endpoints The primary endpoint is the~     opioid use during the first 24 hours after start of surgery. Secondary endpoints are the VAS~     score on day 0 and day 1 after surgery, and the prevalence of postoperative nausea and~     vomiting (PONV).~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness In the intra-operative period, patients will not experience discomfort from~     either strategy because of general anesthesia. If the hypothesis proves to be true, patients~     with SIP block could benefit from a lower amount of received opioids, which could give less~     chance of opioid associated adverse effects. There won't be any additional blood sampling~     related to this study.~   "
8987|NCT03449212|"~     Washington University in St. Louis is seeking participants with ALS for a study to determine~     the half-life of the protein SOD1 in the cerebral spinal fluid. Mutations in the SOD1 gene~     are known to cause some forms of familial ALS. Researchers are developing a treatment to~     reduce the level of SOD1 in familial ALS, but need to know more about how long SOD1 stays in~     the body (half-life) to help determine if the new treatment is effective.~   "
8979|NCT03449316|"~     Introduction COPD and Asthma affect more than 10% of the population. Most patients use their~     inhaler incorrectly, mainly the elderly, thereby becoming more susceptible to poor clinical~     control and exacerbations. Placebo device training is regarded as one of the best teaching~     methods, but there is scarce evidence to support it as the most effective one to improve~     major clinical outcomes. Our objective is to perform a single-blinded RCT to assess the~     impact of this education tool in these patients.~      Methods and Analysis A multicentre single-blinded RCT will be set, comparing a placebo-device~     training programme versus usual care, with a one-year follow-up, in elderly patients with~     Asthma or COPD. Intervention will be provided at baseline, and after 3 and 6 months, with~     interim analysis at an intermediate time point. Exacerbation rates were set as primary~     outcomes, and quality of life, adherence rates, clinical control and respiratory function~     were chosen as secondary outcomes. A sample size of 146 participants (73 in each arm) was~     estimated as adequate to detect a 50% reduction in event rates. Two-sample proportions~     Chi-squared test will be used to study primary outcome and subgroup analysis will be carried~     out according to major baseline characteristics.~      Discussion The investigators expect to confirm that inhaler performance education will~     significantly reduce exacerbation rate and improve clinical and functional control.~      Ethics and dissemination:~      Every participant will sign a consent form. A Data Safety Monitoring Board will be set up to~     evaluate data throughout the study and to monitor stop earlier criteria. Identity of all~     participants will be protected. Results will be presented in scientific meeting and published~     in peer-reviewed journals.~   "
8980|NCT03449303|"~     This study will evaluate an oil blend with active ingredients for the reduction in~     chemotherapy-induced peripheral neuropathy in people with breast cancer. Half of the~     participants will receive the oil blend with active ingredients and the other half will~     receive a placebo (an oil blend with no active ingredients). One-fourth of the people will~     also take pictures of their life with chemotherapy-induced peripheral neuropathy.~   "
8981|NCT03449290|"~     This study aimed to investigate the short-term effects of trunk kinesio taping on trunk~     muscle endurance and postural stability in healthy young adults.~   "
8982|NCT03449277|"~     Hypertensive disorders of pregnancy are important cause of severe morbidity, long-term~     disability and death among both mothers and their babies. In Africa and Asia, nearly one~     tenth of all maternal deaths are associated with hypertensive disorders of pregnancy research~     has focused on the antenatal complications' for both mother and baby and the risks and~     benefits of administering antihypertensive therapy prior to delivery hypertension disorders~     of pregnancy often persist following delivery and sometimes arise de novo postpartum one of~     the maternal complications of pre eclampsia is residual chronic hypertension in about 1/3 of~     cases elevated blood pressure is seen in 6%to 8% of all pregnancies hypertension (arterial~     pressure >140/90 mmhg) in pregnancy is classified into one of four conditions~        1. chronic hypertension that precedes pregnancy~        2. pre eclampsia and eclampsia: a systematic syndrome of elevated arterial~          pressure,proteinuria and other findings~        3. pre eclampsia superimposed upon chronic hypertension~        4. gestational hypertension or nonproteinuric hypertension of pregnancy~   "
8983|NCT03449264|"~     The BCB is a tool:~        -  for research in analytical and public health epidemiology, biological research and for~          the development of data useful for clinical research and therapeutic trials;~        -  to help scientists understand and explain phenomena ranging from the interaction of~          molecules to the whole metabolism of the organism in normal and pathological situations;~        -  to identify potential strategies for prevention, diagnosis, management and analysis of~          cancer subtypes.~      The creation of a broad clinical and biological prospective base dedicated to different types~     of cancer is essential for the development of such projects.~   "
8984|NCT03449251|"~     Type two diabetes mellitus (T2DM) is a common, long term metabolic disorder characterised by~     hyperglycaemia (high blood glucose) resulting from insulin resistance and relative insulin~     insufficiency. The risk of developing insulin resistance and subsequently T2DM is increased~     by being overweight and also through a sedentary lifestyle. As the onset can be gradual,~     physiological damage may have occurred prior to diagnosis. Diabetes is associated with the~     development of microvascular complications (diabetic nephropathy, neuropathy, and~     retinopathy), and macrovascular complications (coronary artery disease, peripheral arterial~     disease, and stroke). While there are many treatments available for T2DM, these complications~     may still arise, leading to significant morbidity and mortality. There is therefore an urgent~     need to identify novel signalling pathways that may contribute to the development of diabetes~     related complications. The identification of these pathways may ultimately lead to the~     development of new therapies targeting better blood glucose control and preventing these~     subsequent complications.~      Both animal and human studies have indicated that two endogenous peptides, apelin and relaxin~     both act as vasodilators in the human cardiovascular system and could also have beneficial~     action in T2DM. Therefore, we aim to carry out experimental medicine studies to test this~     hypothesis, and explore the signalling pathway in the human vascular system.~   "
8985|NCT03449238|"~     Patients with metastatic breast cancer with at least 2 brain metastases will receive~     pembrolizumab every 3 weeks. Patients will undergo stereotactic radiosurgery (SRS) to one of~     the brain lesions. Pembrolizumab will be infused a day before SRS at the standard dose of~     200mg IV over 30 minutes and repeated every 3 weeks until disease progression or unacceptable~     toxicity.~   "
8986|NCT03449225|"~     A standard part of obstetrical care is offering prenatal genetic screening. Numerous~     professional guidelines have emphasized the importance of pretest counseling for prenatal~     genetic screenings. Informed consent includes the optional nature of the test, information on~     the conditions being screened, possible test results, implication of each result, and the~     type of test offered (screening or diagnostic). This responsibility falls on the physician in~     a busy clinic. Technology may be able to address this limitation and give consistent pretest~     counseling for patients waiting for their appointment. This study is looking to evaluate the~     use of computer-aided genetics education module for facilitating decision making about~     prenatal genetic screening and testing for fetal chromosome conditions and carrier status.~   "
9203|NCT03446391|"~     The aim of this study is to evaluate postoperative knee function after total knee~     arthroplasty performed according to the anatomical alignment and compare these results to~     those of a matched historical cohort of patients operated with mechanical alignment.~   "
8988|NCT03449199|"~     The primary objective of this study is to assess the effect of 2 dose levels of TMX-049 on~     urinary albumin excretion in subjects with Type 2 diabetes and albuminuria (a urinary~     albumin-to-creatinine ratio (UACR) 200 to 3000 mg/g and an estimated glomerular filtration~     rate (eGFR) ≥30 ml/min/1.73m2). Effects of each TMX-049 dose on UACR will be assessed in~     terms of ratios using log-transformed UACR at Baseline and after a 12-week period of~     treatment.~   "
8989|NCT03449186|"~     The aim of this study was to investigate salivary and gingival crevicular fluid (GCF) levels~     of IL-17A, IL-17E, IL-6 AND IL-23 during 2/3 trimester of pregnancy and after delivery.~   "
8990|NCT03449173|"~     Study to investigate response to sunitinib in patients with thymic epithelial tumours who had~     progressive disease after at least one previous regimen of platinum-based chemotherapy.~   "
8991|NCT03449160|"~     Participants with low back pain who are referred for physical therapy will be randomized to~     routine physical therapy or routine physical therapy plus receiving a postural training~     device~   "
8992|NCT03449147|"~     The primary objective of this study will be to evaluate the efficacy of gefapixant (MK-7264)~     in reducing cough frequency as measured over a 24-hour period. It is hypothesized that at~     least one dose of gefapixant is superior to placebo in reducing coughs per hour (over 24~     hours).~   "
8993|NCT03449134|"~     The primary objective of this study was to evaluate the efficacy of gefapixant in reducing~     cough frequency as measured over a 24-hour period.~   "
8994|NCT03449121|"~     Slow breathing may reduce stress. Adults with congestive heart failure have higher stress~     than the general population. This study will examine if using slow breathing is feasible~     among adults with heart failure.~   "
8995|NCT03449108|"~     The goal of this clinical research study is to learn if LN-145 can help to control soft~     tissue sarcoma, osteosarcoma, or ovarian cancer that is recurrent (has come back after~     treatment).~      LN-145 is made by collecting and growing specialized white blood cells (called T-cells) that~     are collected from your own tumor.~      This is an investigational study. LN-145 is not FDA approved or commercially available. It is~     currently being used for research purposes only. The study doctor can explain how LN-145 is~     designed to work in more detail.~      Up to 80 participants will be enrolled in this study. All will take part at MD Anderson.~   "
8996|NCT03449095|"~     In this study, the investigators examine whether emotional and social reward from alcohol~     varies depending on the social context of consumption.~   "
8997|NCT03449082|"~     The aim of this study is to evaluate the efficacy and safety of intra-tendon injection of~     allogeneic adipose-derived mesenchymal stem cells (Allo-ASC) in intractable common extensor~     tendinosis patients in comparison with a control treatment.~   "
8998|NCT03449069|"~     The purpose of this study is to determine the safety of using an autologous mesenchymal~     stromal cell (MSC) coated fistula plug in people with fistulizing Crohn's disease. Autologous~     means these cells to coat the plug come from the patient.~   "
8999|NCT03449056|"~     High-flow nasal cannula is an oxygenation technique increasingly used for patients admitted~     for acute respiratory failure. Literature essentially concerns de novo acute hypoxemic~     failure and the interest of high-flow during take care of chronic obstructive pulmonary~     disease patients is few studied. Physiological studies reported potential benefits of~     high-flow nasal cannula oxygenation in chronic obstructive pulmonary disease patients~     including dead space clearance and decrease of respiratory, which lead to decrease work of~     breathing. As inhaled bronchodilators are part of treatment of chronic obstructive pulmonary~     disease exacerbation, nebulization could be also provided through high-flow nasal cannula~     oxygen therapy. The aim of our study is to determine whether a beta-2 agonist nebulization~     administered through High-flow nasal cannula is efficient to improve spirometry of patients~     for admitted hronic obstructive pulmonary disease exacerbation.~   "
9000|NCT03449043|"~     The number of consultations in the emergency services has continued to increase with 19.7~     million passages in 2014, an increase of 4% compared to 2013. Among these admissions, many~     patients come spontaneously to the emergency department and others are sent by the general~     practitioner who remains the first resort in the care of the patient.~      Faced with this massive influx to emergency services, the investigator will see what is the~     future of these. Are they more likely to be hospitalized than patients presenting to~     emergencies on their own?~   "
9001|NCT03449030|"~     The purpose of this study is to evaluate the safety of TAK-164 and to determine the maximum~     tolerated dose (MTD) and recommended phase 2 dose (RP2D) and schedule.~   "
9002|NCT03449017|"~     The purpose of this study is to 1) examine cognitive acuity following e-cig use (as compared~     to no e-cig use), 2) examine motor coordination following beer and e-cig use (as compared to~     beer consumption only).~   "
9003|NCT03449004|"~     Low Back Pain (LBP) is the most common musculoskeletal disorder and a leading cause of~     disability worldwide. It is the most frequent reason for consulting general practice and has~     an impact on daily life and work capacity. A cornerstone in treating LBP is the provision of~     information to patients, and the internet is increasingly being used as a source of health~     information delivery. However, the effect of and satisfaction with online information have~     been questioned. The investigators aimed to develop and validate a multi-item instrument to~     measure an index score of satisfaction of online information for patients with LBP.~      The conceptualization of a Patient Reported Outcome (PRO) to measure a multidimensional index~     score is modelled on the assumption of a causal relationship between domains of experiences~     with online information and patients' combined index score of satisfaction. Findings from 15~     patient interviews was applied to draft the first version of the instrument. Followed by~     pilot testing on patients (n=20) and experts (n=7) before validating the instrument on~     patients (n=150). Patients were eligible for inclusion if they had their first onset of LBP~     for 14 days. Patients were included regardless of pain intensity. Patients were excluded if~     they did not have Internet access, were pregnant, did not speak Danish as their native~     language, or had signs of serious underlying disease.~   "
9055|NCT03448328|"~     The purpose of this study is to determine if supplementation with NUTRALYS pea protein~     isolate compared to whey protein and apple juice (carbohydrate, non-protein control) before,~     during, and after a 90-minute bout of eccentric exercise can attenuate exercise-induced~     muscle damage, inflammation, and delayed onset of muscle soreness (DOMS), and speed recovery~     of muscle function.~   "
9004|NCT03448991|"~     According to normal physiology, the longer fasting period allows food particles to pass~     stomach through small intestines to minimize intragastric content. The practice guidelines~     recommend 2-hour fasting period for clear fluid (including water, pulp-free juice and tea or~     coffee without milk), 4- hour fasting period for breast milk and 6-hour fasting period for~     non-human milk and solid food to reduce risks of pulmonary aspiration. As a result of longer~     fasting period, patients tend to experience preoperative dehydrated states and intraoperative~     hypotension. Patients' demographic data will be obtained from charts. Parents will be asked~     for type, volume of fluid/food intake and NPO time.~      This study will be done at BCH's Gastroenterology Procedure Unit (GPU) theaters to measure~     actual intragastric volume and pH at the beginning esopagogastroduodenoscopy procedures. We~     hope to demonstrate the relationship between NPO time and actual intragastric volume which~     provide sufficient data of NPO time to ensure patient's safety.~   "
9005|NCT03448978|"~     This Phase I study will test the safety and anti-myeloma activity of ascending doses of~     Descartes-08 (autologous CD8+ T-cells transiently expressing an anti-BCMA chimeric antigen~     receptor) in eligible patients with active multiple myeloma.~   "
9006|NCT03448965|"~     Definition of low birth weight:~      Low birth weight infants are those born weighing less than 2500 g. These are further~     subdivided into:~        -  Very Low Birth Weight : Birth weight <1,500 g~        -  Extremely Low Birth Weight : Birth weight <1,000 g Their survival is directly related to~          birth weight, with approximately 20% of those between 500 and 600 g and>90% of those~          between 1,250 and 1,500 g surviving. Perinatalcare has improved the rate of survival of~          low birth weight infants.~   "
9007|NCT03448952|"~     Thrombocytopenia is diagnosed when platelet count is lower than 150,000 U/L, it is a common~     hemostatic problem in neonatal intensive care units According to platelets count, it is~     classified into mild thrombocytopenia with platelet count 100,000 to 150,000 U/L, moderate~     thrombocytopenia with platelet count 50,000 to 100,000 U/L and severe thrombocytopenia that~     have platelet count less than or equal to 50,000 U/L.~   "
9008|NCT03448939|"~     To assess the efficacy and safety of S5G4T-1 compared to S5G4T-1 Vehicle when applied once~     daily for 12 weeks in patients with papulopustular rosacea~   "
9009|NCT03448926|"~     This is a prospective cohort study for patients diagnosed with ductal carcinoma in situ~     (DCIS) of the breast. The primary objective of the study is to create a de-identified~     database of patients, test results, treatment decisions and outcomes that can be queried to~     determine the utility of the DCISionRT™ test in the diagnosis and treatment of ductal~     carcinoma in situ of the breast.~   "
9010|NCT03448913|"~     This observational study evaluates difference in chronic pain after six months from surgery~     between patients who received PECS block and general anesthesia versus general anesthesia~     alone.~   "
9011|NCT03448900|"~     This study evaluate the effectiveness of a nurse multi-component intervention aimed at~     helping Spanish college student smokers to quit smoking.~   "
9012|NCT03448887|"~     Theranova is a novel medium cut-off (MCO) dialyzer. Previous studies identified that~     theranova dialyzer had superior performance on middle molecule removal to conventional~     hemodialysis (HD) and hemodiafiltration (HDF). The present study addresses to compare~     clinical outcomes including cardiovascular endpoint between HD with theranova dialyzer and~     HDF.~   "
9013|NCT03448874|"~     The purpose of this study is to evaluate safety of Seal-G MIST System in reinforcing~     colorectal anastomosis, in subjects undergoing colorectal surgery.~   "
9014|NCT03448861|"~     ChroniSense Medical Ltd. is developing a wearable medical multi-parametric monitoring system,~     Polso™. Polso™ provides a number of the parameters employed in various Early Warning Scores~     (EWS), such as the National Early Warning Score (NEWS), utilised widely in UK hospitals.~      The EWS is a physiological track and trigger system that is generated from multi- parameter~     or aggregate of vital signs measurements for early recognition of clinical deterioration in~     acutely admitted patients. Patients who are admitted into hospital are monitored with~     routinely measurements of these parameters that are manually recorded on a clinical chart.~   "
9015|NCT03448848|"~     The purpose of this study is to evaluate the impact of intravenous BCAAs infusion as adjunct~     therapy post liver surgery in intensive care unit (ICU).~   "
9016|NCT03448835|"~     In this explorative study, patients with resectabel cancer of the stomach or~     stomach-oesophagealjunction cancer will receive neoadjuvant treatment.~      The treatment will be 1 cyle atzolizumab monotherapy, followed by 4 cycle of atezolizumab and~     capecitabine, oxaliplatin and docetaxel.~   "
9017|NCT03448822|"~     Assessment of accuracy of sentinel node biopsy, defined as the false negative rate.~   "
9018|NCT03448809|"~     In this feasibility RCT of the modular and flexible cognitive and behavioural therapy (Mind~     My Mind, MMM) compared with treatment as usual, the overall research aim was to explore the~     trial design and the acceptability of the assessments, interventions and outcome measures~     among children, parents, teachers and therapists, and secondly to provide data to estimate~     the parameters required to design a definitive RCT.~   "
9019|NCT03448796|"~     A prospective, randomised controlled trial where clinical and radiological outcome of high~     tibial opening wedge osteotomy with physiotherapy is compared to physiotherapy alone while~     treating symptomatic medial knee osteoarthrosis.~   "
9020|NCT03448783|"~     Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the~     pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the~     pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery.~     Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological~     availability of medication. In this study we investigate the pharmacokinetic effects of~     bariatric surgery on apixaban.~   "
9021|NCT03448770|"~     All patients presenting to the emergency department of Institute of Liver and Biliary~     Sciences with known cirrhosis and hepatic encephalopathy with grade II will be included in~     the study. The patient will be randomized into one of the two arms of lactulose or~     polyethylene glycol. The patient on the lactulose arm will be administered 20 to 30 g of~     lactulose orally or by nasogastric tube (3 or more doses within 24 hours ) or if oral intake~     was not possible or inadequate. The Dose will be repeated to ensure 3-4 loose motions per~     day. The Polyethylene Glycol group will get 17 gm of PEG (Polyethylene Glycol) administered~     orally or via nasogastric tube. PEG (Polyethylene Glycol)will be administered in 3-4 doses in~     24 hours to ensure 3-4 loose stools per day.~   "
9022|NCT03448757|"~     Biofeedback is an autonomic response observed during the exposure period to CEMBE. After~     prospectively evaluating 20 healthy individuals or 40 patients with advanced breast cancer or~     hepatocarcinoma, it was possible to determine subtle hemodynamic changes consistent with the~     biofeedback effect associated with exposure to a cancer-specific set of modulated~     frequencies.~      Once CEMBE is administered through an intra-oral administration device, the human body~     absorbs the energy applied at the level of 0.2-1 mW / kg, with a peak absorption in 10 g of~     tissue between 55 and 132 mW / kg. Initially, the discriminatory study analyzing 9~     hemodynamic parameters recorded beat heart beat in 18 individuals demonstrated a hemodynamic~     pattern specific for hepatocarcinoma and breast cancer, with sensitivity of 94.1% and 95%,~     respectively, and specificity of 75% and 95%, respectively. These findings were validated in~     blind analysis in the remaining 56 patients, confirming the high rate of discriminatory~     success.~      A specific pattern of response associated with exposure of a cancer-specific frequency group~     was also observed in patients diagnosed with neoplasia, since the control group of healthy~     individuals did not present these response patterns.~      This specific signature of response to CEMBE-modulated exposure to cancer-specific~     frequencies was significantly altered only in patients with hepatocarcinoma after tumor~     withdrawal (Costa et al, 2015a).~   "
9023|NCT03448744|"~     This is a multicenter, randomized, open-label control trial of two arms conducted at 10~     centres in China.The aim was to investigate whether sequential combination therapy with~     Thymosin alpha 1 and entecavir is superior to continuous ETV monotherapy in HBeAg-positive~     chronic hepatitis B patients with previous long-term entecavir therapy (≥ 2 years), and to~     select the optimal patients who may benefit from sequential combination therapy.~   "
9024|NCT03448731|"~     Clinical evidence has suggested that sub-antimicrobial doses of doxycycline may have the~     potential to treat inflammatory lesions of acne. The efficacy of doses below 100 mg/day of~     doxycycline in the prevention of skin toxicity in patients with treated with Epidermal Growth~     Factor Receptor (EGFR)-targeted therapies has never been studied. Therefore, the aim of the~     present study is to describe the efficacy of doxycycline 50 or 100 mg per day in the~     prevention of skin toxicity in patients with metastatic Colorectal cancer (mCRC) treated with~     anti-EGFR in combination with chemotherapy.~   "
9025|NCT03448718|"~     This is a single arm open label multi-institutional phase II trial of olaparib monotherapy in~     subjects with metastatic urothelial cancer harboring somatic DNA damage response (DDR)~     alterations. The primary objective of the study is to estimate the objective response rate~     (per RECIST 1.1) to treatment with olaparib.~   "
9026|NCT03448705|"~     The primary objective of the study is to evaluate the safe usability of the study drugs, i.e.~     4Fluart ID 1 µg haemagglutinin (HA)/0.1 ml QIV and 4Fluart ID 2 µg haemagglutinin (HA)/0.1 ml~     QIV in terms of safety concerns emerged.~      The secondary objective of the study is to further assess safety in terms of safety~     parameters, as well as to assess the immunogenicity of 4Fluart ID 1 µg haemagglutinin~     (HA)/0.1 ml QIV and 4Fluart ID 2 µg haemagglutinin (HA)/0.1 ml QIV in terms of immunogenicity~     parameters.~   "
9027|NCT03448692|"~     The purpose of this Phase 2 adaptive study is to evaluate the efficacy, safety, tolerability~     and pharmacokinetics of PF-06730512 following multiple injections in adult subjects with~     primary FSGS. In addition, the intention is to obtain an early indication of efficacy. This~     study may have two doses in two separate cohorts, and it will be conducted in 2 phases: an~     optional longitudinal observational Natural History Phase (Part A) and an adaptive Treatment~     Phase (Part B).~   "
9028|NCT03448679|"~     To study the correlation between colloid osmotic pressure, albumin and the loss of vascular~     integrity in terms of endothelial dysfunction in patients with ESLD undergoing OLT and its~     impact on the perioperative course, as well as on morbidity and mortality.~   "
9029|NCT03448666|"~     This is a Phase 2 multicenter, open label, non-randomized, interventional study enrolling 53~     patients.The objectives and purposes of the clinical study described herein are to determine~     if concomitant Pembrolizumab (Keytruda) and ECT treatments are safe and able to improve local~     and systemic response rates.ECT will be performed with the CLINIPORATOR and a single IV dose~     of Bleomycin~   "
9030|NCT03448653|"~     This prospective bicentric trial aims to evaluate the diagnostic performance of the~     characterization of scalloped polyps less than 20 millimeter in NBI (Narrow Band Imaging) in~     patients with screening colonoscopy.~      The NBI is a so-called virtual electronic staining technique available on conventional~     OLYMPUS endoscopes without additional intervention.~      The colonoscopy procedure for each patient will not be different from a conventional~     colonoscopy examination with excision of all polyps visualized and anatomopathological~     analysis, except for a short time of analysis in NBI for each polyp detected before excision~     to classify the polyp in existing endoscopic classifications (ie NICE classification for~     adenomatous polyps and WASP classification for festooned polyps).~   "
9031|NCT03448640|"~     Because of the neonatologists reported that some infants had suffered from vomiting,~     bradycardia, hypotonia, and aspiration risk about 30-60 minutes after the fundus examination~     in the intensive care unit. The investigators observed the pupil dilation effects and side~     effects of tipple instillation of phenylephrine 2.5% plus tropicamide 0.5% ophthalmic drop~     combination which the investigators routinely used in ROP examination.~   "
9032|NCT03448627|"~     Pulmonary functions, exercise capacity and muscle strength deteriorate in survived~     hematopoietic stem cell transplantation (HSCT) recipients due to toxic effects of~     chemotherapy, radiotherapy, conditioning regimens and/or corticosteroid use before HSCT,~     prolonged stay of recipients in rooms with laminar airflow and strict infection control rules~     during process of HSCT. There are also limited numbers of studies demonstrated pulmonary~     function abnormalities, decreased maximal exercise capacity, respiratory and peripheral~     muscle weakness in recipients. Current study was planned since no study compared pulmonary~     functions, maximal exercise capacity, respiratory and peripheral muscle strength between~     recipients and healthy individuals in the literature.~   "
9056|NCT03448315|"~     the role of transcranial magnetic stimulation over the primary motor cortex area on acute~     postoperative pain after breast cancer surgery and on the probability of developing chronic~     neuropathic pain.~   "
9241|NCT03445897|"~     Bolivian cutaneous leishmaniasis due to Leishmania braziliensis was treated with the~     combination of miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120~     ug/mm2 lesion area on days 1, 3, and 5).~   "
9033|NCT03448614|"~     Endonasal endoscopic approach to the skull base has been expanded in the last several years~     owing to advances in the radiological aspect that provided a better evaluation of the lesions~     and the surrounding structures, technological advances that include angled endoscope,~     development of high-resolution cameras, high definition monitors and navigation systems and~     better anatomical experience. The endoscopic endonasal approach now provides access to~     frontal sinus to the second cervical vertebra in the sagittal plane and from the sella to the~     jugular foramen in the coronal plane. Endoscopic resection of large skull base tumors results~     in large defect for which repair is a challenge. Several factors besides the size of the~     defect should be considered during skull base repair as CSF leak, CSF pressure, history or~     need for future radiotherapy, lack of support and local tissue vascularity. The aim of this~     study is to Provide an algorithmic approach for skull base reconstruction after endonasal~     cranio-endoscopic resection using autologous grafts according to the extent of resection,~     skull base defect size, the presence of CSF leak, CSF pressure and local tissue vascular~   "
9034|NCT03448601|"~     This mixed-methods, multi-state study will develop and evaluate culturally tailored~     recruitment materials and test their effectiveness for a) engaging American Indian and Alaska~     Native participants in a culturally tailored recruitment and engagement module focused on~     Alzheimer's Disease and Precision Medicine (AD-PM); b) enhancing enrollment in AD-PM clinical~     trials; and c) improving knowledge and attitudes about AD and PM.~   "
9035|NCT03448588|"~     As one of the essential micronutrients, selenium has important biological functions. However,~     an effective and convenient method for evaluation of selenium nutritional status has not yet~     been established. Previous literature has disclosed effect of selenium deficiency on~     inactivating glutathion peroxidase and deiodinase, which may cause decreased conversion from~     thyroxine ( T4) to triiodothyronine (T3). A case-control study is designed to demonstrate the~     association between selenium deficiency and abnormally elevated T4 or T4/T3, which may~     provide more clues for establishing effective selenium assesment methods.~   "
9036|NCT03448575|"~     This study tests the effectiveness of an intervention treatment algorithm vs. usual care~     control in a practical clinical trial. Control arm providers will receive a standard~     medication alert in the electronic medical record (EMR) when initiating an antipsychotic~     prescription for an eligible patient. Intervention arm prescribers will receive an~     interactive medication alert in the EMR when prescribing for eligible patients and the~     patient and provider will enter the treatment algorithm (provider - medication alert plus~     clinical review by a child psychiatrist; patient - offer of personalized behavioral health~     navigation plus bridging therapy when appropriate). The study aims to recruit 800 eligible~     patients in 4 health systems.~   "
9037|NCT03448562|"~     The primary objective of this investigation is to compare the efficacy of two different AF~     ablation strategies in patients with non-paroxysmal AF: CPVI plus electrophysiologic~     substrate ablation in the left atrium during sinus rhythm (STABLE-SR) and CPVI alone.~   "
9038|NCT03448549|"~     Fluorouracil combined with oxaliplatin are routinely recommended to patients with~     pathological stage III (p-stage III) colorectal cancer, leading to significant improvement of~     5-year disease-free survival and overall survival (approximately 3.4% -4.2%) by by~     international guidelines such as the National Cancer Comprehensive Network. The Considerable~     proportion of patients suffer with hand-foot syndrome due to capecitabine as commonly~     prescribed. Meanwhile as another agent of fluorouracil, tegafur，gimeracil and oteracil~     potassium (short for TGOP) has been shown with similar effect and less adverse reaction. This~     study was designed to investigate the short-term and long-term safety and efficacy of TGOP-OX~     and XELOX regimens in colorectal cancer p-stage III patients who undergo curative surgery and~     adjuvant chemotherapy, and to explore the compliance and quality of life in patients treated~     with TGOP-OX regime.~   "
9039|NCT03448536|"~     The purpose of this study is to compare the maximum single dose of Aleve® (two tablets,~     equivalent to 440 mg of naproxen sodium) to the maximum single dose of Tylenol Extra Strength~     (two tablets, equivalent to 1000 mg of acetaminophen) in the treatment of menstrual pain~     associated with primary dysmenorrhea.~   "
9040|NCT03448523|"~     This is a RCT conducted with 1752 children in 40 public middle schools in Hyderabad Pakistan~     with the goal of evaluating the effectiveness of the international non-governmental~     organisation Right To Play's Positive Child and Youth Development program on reducing peer~     violence perpetration and victimisation and child depression in a two arm trial where this~     intervention is compared to a no intervention arm.~   "
9041|NCT03448510|"~     Irreversible electroporation (IRE) is a novel ablation modality using electric pulses to~     create nanoscale defects in the cell membrane. It has been verified to be safe on the~     treatment of prostate, lung, liver and kidney masses. The present is a randomized, controlled~     trial, with a main purpose of looking into the safety and feasibility of irreversible~     electroporation for patients with benign prostatic obstruction.~   "
9042|NCT03448497|"~     The purpose of this study is to describe the first-line therapy landscape for patients with~     advanced melanoma and to describe clinical outcomes and healthcare resource utilization in a~     subset of treatment-naïve patients who initiated nivolumab + ipilimumab combination therapy.~   "
9057|NCT03448302|"~     Colorectal cancer is the third most commonly diagnosed cancer in the world. The 5-years~     survival rate depends on the tumor stage and grade at patient presentation. Individual~     treatment strategy based on the tumor stage and grade should be applied to improve the~     prognosis, So the pre-operative diagnostic evaluation and grading of colorectal cancer are~     important.~   "
9070|NCT03448133|"~     The primary progressive aphasia (PPA) is a neurodegenerative condition characterized by a~     gradual, irreversible decline of language function (Mesulam, 2001). There are no known~     treatments for PPA so far. The relentless progression of PPA symptoms eventually leads to a~     profound impairment in communication ability and, ultimately, to more generalized deficits of~     cognition. Some cases and small studies reported that Transcranial Magnetic Stimulation~     (TMS), one of the non-invasive neuromodulation tech, can be employed to facilitate language~     production and improve the language ability in patients with PPA. Herein we will explore the~     tolerance and efficacy of TMS for the treatment of PPA by the randomized controlled trial~     .Meanwhile the functional MRI tech will be used to investigate the neural network changing in~     the procedure~   "
9043|NCT03448484|"~     Malnutrition is a public health problem in Kenya, with 26% of children under-five years of~     age stunted, and 26% of pre-school children, 26% of women of reproductive age and 42% of~     pregnant women being anaemic, respectively. Agriculture is the main source of income, food~     and nutrients for the majority of rural families in Sub-Saharan Africa including Kenya. Most~     farmers are smallholders and are vulnerable to poor nutrition. Thus far, programmes have~     mostly focused on increasing yields and household income, but not on improving nutritional~     status. One Acre Fund (1AF) has over the past 10 years successfully introduced an agriculture~     programme to smallholder farmers in Western Kenya focusing on improving harvest. 1AF is~     therefore well placed to transform an existing and successful agriculture programme into the~     world's largest 'nutrition network' for farmers, and it is the hope that a partnership~     between Children's Investment Fund Foundation (CIFF) and 1AF will create a strong voice for~     nutrition within the agriculture sector. The project aims to use an integrated programme by~     introducing nutrition-sensitive (improved water, sanitation and hygiene (WASH): e.g. soap for~     hand washing) and nutrition-specific (e.g. micronutrient supplements) components to 1AF's~     agricultural programme.~      The impact of such an integrated programme will be assessed in a cluster-randomized~     intervention study in children 6-35 months at recruitment comparing one group receiving the~     integrated intervention to another group receiving the agricultural intervention (already in~     place).~   "
9044|NCT03448471|"~     Fatigue is a common symptom during allogeneic-hematopoietic stem cell transplantation~     (allo-HSCT). However, effects of severe fatigue on pulmonary functions, blood cells, dyspnea,~     muscle strength, exercise capacity, depression and quality of life (QOL) in allo-HSCT~     recipients are still unknown.~   "
9045|NCT03448458|"~     This pilot clinical trial studies how well gallium Ga 68-DOTATATE positron emission~     tomography (PET)/computed tomography (CT) works in treating patients with castration~     resistant prostate cancer that has spread to other placed in the body. Gallium Ga 68-DOTATATE~     PET/CT may help doctors to identify those patients with early neuroendocrine~     transdifferentiation and who are at greater risk for poor outcomes.~   "
9046|NCT03448445|"~     This study will be conducted to evaluate the rate of Alzheimer's disease conversion~     differences between high-risk mild cognitive impairment (MCI) and low-risk MCI.~   "
9047|NCT03448432|"~     Anemia during pregnancy occurs in 41% of women. The most common etiology is iron deficiency,~     but studies to determine prevalence of other causes of anemia in pregnancy are still lacking.~     However, anemia in pregnancy lead to adverse pregnancy outcomes and increase risk of maternal~     and fœtal morbidity and mortality. Specific management of anemia is so needed.~   "
9048|NCT03448419|"~     The primary objective of the study is to evaluate the effect of empagliflozin 10 mg versus~     placebo on exercise ability using the 6 minute walk test in patients with chronic HF with~     reduced ejection fraction (LVEF ≤ 40%) Secondary objectives are to assess Patient-Reported~     Outcome (PRO)~   "
9049|NCT03448406|"~     The primary objective of the study is to evaluate the effect of empagliflozin 10 mg versus~     placebo on exercise ability using the 6 minute walk test (6MWT) in patients with chronic~     heart failure (CHF) with preserved ejection fraction (LVEF > 40%).~      Secondary objectives are to assess Patient-Reported Outcome (PRO)~   "
9050|NCT03448393|"~     Background:~      B-cell leukemias and lymphomas are cancers that are often difficult to treat. The primary~     objective of this study is to determine the ability to take a patient's own cells (T~     lymphocytes) and grow them in the laboratory with the CD19/CD22-CAR receptor gene through a~     process called 'lentiviral transduction (also considered gene therapy) and growing them to~     large numbers to use as a treatment for hematologic cancers in children and young adults..~     Researchers want to see if giving modified CD19/CD22-CAR T cells to people with these cancers~     can attack cancer cells. In addition, the safety of giving these gene modified cells to~     humans will be tested at different cell doses. Additional objectives are to determine if this~     therapy can cause regression of B cell cancers and to measure if the gene modified cells~     survive in patients blood.~      Objective:~      To study the safety and effects of giving CD19/CD22-CAR T cells to children and young adults~     with B-cell cancer.~      Eligibility:~      People ages 3 30 with certain cancers that have not been cured by standard therapy. Their~     cancer tissue must express the CD19 protein.~      Design:~      A sample of participants blood or bone marrow will be sent to NIH and tested for leukemia.~      Participants will be screened with:~      Medical history~      Physical exam~      Urine and blood tests (including for HIV)~      Heart and eye tests~      Neurologic assessment and symptom checklist.~      Scans, bone marrow biopsy, and/or spinal tap~      Some participants will have lung tests.~      Participants will repeat these tests throughout the study and follow-up.~      Participants will have leukapheresis. Blood will be drawn from a plastic tube (IV) or needle~     in one arm then go through a machine that removes lymphocytes. The remaining blood will be~     returned to the participant s other arm.~      Participants will stay in the hospital about 2 weeks. There they will get:~      Two chemotherapy drugs by IV~      Their changed cells by IV~      Standard drugs for side effects~      Participants will have frequent follow-up visits for 1 year, then 5 visits for the next 4~     years. Then they will answer questions and have blood tests every year for 15 years.~   "
9051|NCT03448380|"~     This is a prospective, multi-center, non-randomized, single-arm, post-approval study of the~     FreeStyle Libre Flash Glucose Monitoring System intended to characterize the safety of the~     Libre Flash Glucose Monitoring System when used in people with diabetes.~   "
9052|NCT03448367|"~     This is a prospective, multi-center, non-randomized, single-arm, post-approval study of the~     FreeStyle Libre Flash Glucose Monitoring System intended to characterize the safety of the~     Libre Flash Glucose Monitoring System when used in pediatric patients with diabetes.~   "
9053|NCT03448354|"~     Ovarian cancer is a lethal malignancy and reported as a fifth leading cause of death in all~     age in the developed country. Most of the ovarian cancer patients are diagnosed at advanced~     stages due to an inadequate screening tool and a lack of clinical symptoms. Optimal~     cytoreductive surgery with no gross residual disease followed platinum-based adjuvant~     chemotherapy has been the most effective therapeutic strategy in the treatment of advanced~     ovarian cancer. However, the optimal surgical procedure is not always possible, especially in~     patients with extensive disease or women with poor performance status. Neoadjuvant~     chemotherapy(NAC) followed interval debulking surgery (IDS) is an alternative therapeutic~     option for these patients. There is growing interest in the use of HIPEC (hyperthermic~     intraperitoneal chemotherapy) for ovarian cancer, and early data on HIPEC as a component of~     front-line therapy of advanced ovarian cancer are encouraging. However, intraperitoneal~     chemotherapy is not actively used in the treatment of ovarian cancer due to the~     catheter-related complications or inconvenience. The aim of this study is to evaluate the~     effectiveness and safety of HIPEC after interval debulking surgery in advanced ovarian cancer~     patients.~   "
9054|NCT03448341|"~     Nowadays radio-chemotherapy is considered an alternative to surgical treatment in patients~     with locally advanced cancer of the cervico-cephalic district (LA-HNC), in order to guarantee~     organ preservation.~      Radio-induced dysphagia, as a multifactorial final effect, represents the real Achilles~     Heel; it occurs in more than 50% of patients and can lead to a serious state of~     malnutrition, with consequent long-term maintenance of a predominantly enteral nutrition with~     PEG or risk of aspiration pneumonia.~      A therapeutic strategy of organ preservation should guarantee the greater probability of~     tumor control and the minimum damage to the organ functions. Moreover, the reduction of~     symptoms, related to changes in swallowing function and possible complications, could lead to~     an improvement in the patient's quality of life and to a significant reduction in~     hospitalization costs. Intensity Modulated Radiotherapy (IMRT), have shown very promising~     results both in terms of increased tumor control and reduction of toxicity, due to a~     reduction in dose of radiation to the major salivary glands, pharyngeal mucosa and also to~     the structures responsible for swallowing. For a correct and complete evaluation of the~     deglutitory function should be useful the use of both clinical scales and instrumental~     methods. It is strongly recommended by the international scientific community to use, in~     association with the clinical evaluation, appropriate instrumental examinations for a correct~     evaluation of the swallowing function both before and after radiotherapy. The examens that~     are recognized as gold standards in the study of dysphagia are the Endoscopic Fibroscopy of~     Swallowing (FEES) and Videofluoroscopy (VFS). The protocol envisages the use of Swallowing~     Videoendoscopy (FEES) and Videofluoroscopy (VFS), that have to be performed in the baseline~     conditions to assess the presence or absence of dysphagia cancer related, and after 6 and 12~     months to evaluate the effect of the treatment. Patients should also complete a questionnaire~     for the assessment of quality of life in relation to dysphagia problems. The Primary aim is~     the Evaluation of changes of instrumental scores for swallowing function, the Secondary aims~     are the correlation between instrumental scores and clinical score and the dose received from~     each of the SWOARs with the deterioration of the instrumental and clinical scores. The~     evaluation of the swallowing functions effectuated by VFS and FEES have to be done in the 20~     days before the beginning of the treatment (Baseline Evaluation) and then at a distance of 6~     and 12 months from the end of the treatment. Clinical evaluation of the impact of dysphagia~     on quality of life by administering a specific MDADI (MD Anderson Dysphagia Inventory)~     questionnaire at baseline conditions and then at 6 and 12 months. Radiotherapy treatment have~     to be necessarily performed with IMRT technique (static or dynamic). For the optimization~     process of Inverse Planning the primary risk organs (P-OARs) and the secondary risk organs~     must be both identified as Objective Structures (S-OARs), which include the organs~     responsible for swallowing, indicated by the acronym SWOARs. In the treatment planning~     process, the highest priority must be given to respect the constraints on the P-OARs, the PTV~     coverage must have a higher priority than the constraints on the S-OARs.~      In the case of extensive overlapping between PTV and a secondary risk organ (eg for the upper~     constrictor muscle in patients with large nasopharyngeal tumor) it's a medical decision to~     set any dosimetric constraint and to limit the average dose received from the structure in~     analysis. At the end of radiotherapy planning, the average doses received from each of the~     SWOARs must be recorded and will be used in the final statistical analysis. The use of image~     fusion with MRI for the definition of both target volumes and OARs is strongly recommended.~     Finally, the radiation treatment must include the use of on-line verification and correction~     systems for the patient's Set-Up through three-dimensional imaging. The instrumental~     assessment of the swallowing function involves the execution, under basal conditions (in the~     20 days before the beginning of RT) and subsequently at a distance of 6 and 12 months from~     the end of RT, both of the FEES and of the VFS. The exams must be done by specialist doctors~     in Otorhinolaryngology (FEES) and Diagnostic Imaging (VFS), with consolidated experience in~     the field of deglutology. Both tests are important for the evaluation of the pharyngeal phase~     of the swallowing act.~   "
9242|NCT03445884|"~     The aim is to examine the expression of αvβ3 integrin using a novel selective radiotracer in~     patients with myocardial infarction and investigate if it is a suitable tool for predicting~     myocardial recovery and thus prognosis.~   "
9058|NCT03448289|"~     Improved access to timely health care and contraception in the postpartum (PP) period is~     needed to reduce unintended pregnancies and help women achieve desired birth spacing. While~     the routine 6-week visit has historically been considered the place for women to discuss and~     receive contraception, many women, particularly low-income women, do not attend the~     postpartum visit. A novel approach to increasing receipt of PP care and contraception is the~     adoption of a reproductive life planning tool. Explorations of the use of a self-administered~     Reproductive Life Plan Tool (RLPT) by pediatricians in the context of the Well-Baby Visit~     (WBV) with postpartum mothers, holds great promise.~      The objective of this study is to determine whether use of a simple self-administered~     Reproductive Life Plan Tool at the 2-month WBV increases the proportion of postpartum women~     receiving woman's health care and contraception at 6-months PP, compared to women not exposed~     to such an intervention. The two specific aims of the project are: 1) To determine if~     introducing a self-administered Reproductive Life Planning Tool (RLPT) with postpartum~     mothers during the 2-month WBV will increase the proportion of women receiving a well-woman~     primary care health visit by 6 months postpartum; and if introducing a self-administered~     Reproductive Life Planning Tool (RLPT) will increase utilization rates of contraception by 6~     months postpartum. 2) To assess patient-, provider-, and systems-level barriers and~     facilitators to integrating a self-administered Reproductive Life Planning Tool (RLPT)~     designed to facilitate referral of postpartum women for primary well-woman care in the~     context of a pediatric clinic.~      The investigators hypothesize that exposure to a self-administered RLPT combined with a~     conversation with a pediatrician during a 2-month WBV will increase use of well-woman primary~     health care during the postpartum period as well as receipt of contraception, by 6-months~     postpartum. If successful, the results of this study have great potential to inform clinical~     and public health practice to increase women's use of health care and contraception in the~     postpartum period.~   "
9059|NCT03448276|"~     Introduction: Osteoporosis and Osteopenia are common bone disorders, characterized by low~     bone mass, signs of bone deterioration and are responsible for typical bone fragility.~     Physical activity is certainly a valid prevention tool because it contributes to a healthy~     energy balance, increasing muscle mass and providing beneficial effects in bone metabolism.~     Stress induced by more vigorous activities such as weight lifting, increases the risk of~     injury, particularly in the elderly. Therefore, alternative strategies with lower risk of~     injury are indicated such as whole body vibration and walk.~      Objective: Compare the effect whole body vibration and walking on muscular strength, balance~     and functional performance in the elderly with Osteoporosis and Osteopenia~      Methods: It is a clinical trial study, controlled, parallel, randomized and blind, which will~     follow the guidelines established in the Consolidated Standards of Reporting Trials~     (CONSORT). Participants will be randomly distributed in 2 groups: the experimental group (GI)~     that will hold the training in the vibrating platform and the control group (GC) that will~     perform the walk, settling 1 treatment session. All participants will be subjected to the~     initial and final assessment.~   "
9060|NCT03448263|"~     The goal of this research was to relate the occurrence of post-endodontic pain after~     single-visit RCT using Balanced Force technique and two reciprocating system when cryotherapy~     is used. Methodology: All 216 patients had upper or lower molar, premolar or anterior teeth~     selected for conventional RCT for prosthetic reasons detected with only vital pulps. Of the~     sample of 216 teeth, were selected to the 3 instrumentation methods. For hand~     instrumentation, Balanced Force were used. All canals were clean and shaped with hand Flex-R~     files (fMoyco/Union Broach, York PA, USA). For mechanical shaping, all instruments were used~     with a micro motor (VDW, Munich Germany). WaveOne and Reciproc instruments. Final irrigation~     with cold (6oC) 17% EDTA served as a lubricant.~   "
9061|NCT03448250|"~     The trial aims to evaluate the effectiveness of a novel web-based intervention (Optimune),~     which was designed to introduce relevant cognitive-behavioral therapy (CBT) techniques to~     women with breast cancer who are past the active eradication phase and free from disease~     recurrence. The present study will test the hypothesis that Optimune has an impact on immune~     status, markers of inflammation and psychometric outcomes. Therefore, 150 woman with breast~     cancer will be recruited and randomized to two groups: (1) a control group, in which they may~     engage with any treatment (Care-as-Usual, CAU) and receive access to Optimune after a delay~     of 6 months (i.e., CAU/wait list control group), or (2) to a treatment group that immediately~     receives 12-month access to Optimune and may also use CAU. The primary outcome measure is the~     effect on inflammatory parameters six month post-baseline.~   "
9062|NCT03448237|"~     To show the interest of the association of proprioceptive and orthophonic care of dyslexic~     children. The assumption is that proprioceptive support by correcting a centrally located~     spatial localization instability restores the ability to automate.~      It allows a gain of effectiveness of the orthophonic remediation of the reading of dyslexic~     children.~      Interventional comparative study over 9 months, of three modes of care: Speech-language, or~     proprioceptive, or combined (speech therapy or proprioceptive)~   "
9063|NCT03448224|"~     This partially randomized clinical trial studies how well a behavioral intervention works in~     reducing indoor tanning. Artificial ultraviolet indoor tanning increases the chance of~     developing skin cancers. Behavioral interventions use techniques to help participants change~     the way they react to environmental triggers that may cause a negative reaction.~   "
9064|NCT03448211|"~     The primary objective of this study is to determine the MTD of PTS following local and~     intratumoral injections over a treatment course of two 5-day cycles to patients with palpable~     advanced solid malignancies who have failed standard treatment.~   "
9065|NCT03448198|"~     The objective of this study is to validate a new technique for intraoperative quantification~     of the patello-femoral joint kinematics in patients undergoing total knee replacement, and~     for postoperative quantification of implanted knee and general lower limb activity, along~     with relevant muscle dynamics.~   "
9066|NCT03448185|"~     The purpose of this study is to determine whether 1 year of supervised exercise training in~     obese individuals at high risk for developing HF, incorporating high intensity interval~     training (HIIT) two to three times per week in conjunction with daily oral administration of~     omega-3 poly-unsaturated fatty acids will lead to reduction in visceral adiposity, regression~     of myocardial triglyceride levels and improvements in cardiac diastolic and vascular~     function.~   "
9067|NCT03448172|"~     The purpose of the study is to characterize the absorption, distribution, metabolism, and~     excretion (ADME) of a single oral dose of [14C]PF-05221304 in Healthy Adult Male Subjects~   "
9068|NCT03448159|"~     The FLOW trial is a randomized placebo-controlled trial analyzing the effect of coupling an~     anti-depressant, fluoxetine (Prozac), and exercise to improve motor recovery following a~     stroke.~   "
9069|NCT03448146|"~     This trial was to evaluate the efficacy of intratumoral PTS injection in alleviating airway~     obstruction and dyspnea by improving the percentage of lumen patency of patients with central~     air way NSCLC tumor severe obstruction.~   "
9568|NCT03441594|"~     The current pilot study will examine emergent hypotheses by investigating the role of~     psychological mechanisms in the relationship between food insecurity and obesity. This~     objective will be achieved via a cross-sectional, observational pilot study collecting~     quantitative and qualitative data.~   "
9071|NCT03448120|"~     Introduction: Neuromuscular fatigue is defined when the muscle becomes incapable of~     generating muscle power or strength after exercise or long repetitive activities. As well as,~     the inability to maintain optimum performance and generate maximum voluntary contractions~     during a physical exercise. When performing physical activity, the body's metabolic response~     increases proportionally to exercise to satisfy the demands of the human physiological. Part~     of the energy accumulated during exercise is lost to the environment in the form of heat and~     another part is maintained internally through the physiological control for thermoregulation.~     In addition, the muscle generates an electric signal important to determine its status~     regarding power and fatigue.~      Objective: To investigate the reduction of acute peripheral fatigue induced by isometric~     contractions from acupuncture and dry needling techniques, compared to absolute rest.~      Methods: This is a cross-sectional study and experimental study, with descriptive, analytical~     and quantitative approach. It follows the Consolidated Standards of Reporting Trials~     (CONSORT) guidelines. The volunteers will be gathered according to the eligibility criteria,~     and randomly divided in 3 groups: the control group (G1), the volunteers who will remain in~     prolonged rest; the acupuncture group (G2), in which volunteers will receive six needles in~     six acupoints in the non-dominant upper limb and the dry needling group (G3), in which the~     volunteers will receive application of six needles arranged in the non-dominant biceps~     brachialis.~   "
9072|NCT03448107|"~     Dental caries (tooth decay) is the most prevalent childhood disease in the world. Multiple~     interventions are available to treat and prevent caries. The aim of the proposed study is to~     compare the benefit of silver diamine fluoride (SDF) and fluoride varnish versus fluoride~     varnish and glass ionomer sealants. This study is a five-year, cluster randomized, pragmatic~     controlled trial conducted in public elementary schools in New Hampshire.~   "
9073|NCT03448094|"~     Previous research shows that a diet high in fat has harmful effects on gut health. This~     increases the chance of developing obesity-related diseases (such as type 2 diabetes) and~     disrupts cognition and mood.~      Research has suggested that gut health can be improved by taking certain supplements,~     including resveratrol (a polyphenol found primarily in red grape skins). Resveratrol has also~     been shown to improve brain blood flow and possibly brain function - however, there is~     limited research studying this.~      This study will investigate the effects of 12 weeks daily consumption of resveratrol on~     cognitive function, cerebral blood flow, gut microbiota and systemic inflammation in~     overweight and obese healthy adults.~   "
9074|NCT03448081|"~     A Phase 2 study evaluating safety, tolerability, and efficacy of SNA-120 ointment when~     administered topically with calcipotriene ointment for the treatment of pruritus and~     psoriasis.~   "
9075|NCT03448068|"~     Opioid medications such as morphine, hydrocodone and oxycodone are standard for treating pain~     after surgery, however there are disadvantages. Because of the way opioids work, gastric~     bypass patients may have an increased risk of having sedation or problems with breathing. In~     patients with sleep apnea, opioids may increase the risk of severe apnea.~      Ketamine is an alternative pain medicine that can be used to treat pain after surgery and may~     have fewer effects on breathing. Using ketamine as part of the regimen may be a better choice~     for laparoscopic gastric bypass patients.~      This study is being done to find out if intraoperative ketamine infusion combined with~     continuation for twenty-four hours post-surgery provides superior pain control and decreases~     post-operative opioid use versus standard non-ketamine therapy.~   "
9076|NCT03448055|"~     Alzheimer disease (AD) is a dementing illness characterized by progressive neuronal~     degeneration, gliosis, and the accumulation of intracellular inclusions and extracellular~     deposits of amyloid in discrete regions of the basal forebrain, hippocampus, and the~     association cortices. Mild cognitive impairment (MCI) refers to individuals with cognitive~     impairment (often memory loss) that fails to meet clinical criteria for AD or another~     dementing illness.~   "
9077|NCT03448042|"~     This study will evaluate the safety, tolerability, and pharmacokinetics of BTRC4017A in~     participants with locally advanced or metastatic Human Epidermal Growth Factor Receptor 2~     (HER2)-expressing cancers.~   "
9078|NCT03448029|"~     The RECording COurses of vasculaR Diseases registry (RECCORD registry) is an observational,~     prospective, multicentre, all-comers registry platform.~      In the initial phase, patients referred for endovascular revascularization of peripheral~     artery disease (PAD) of the lower limbs will be prospectively included and followed up for at~     least one year.~      At baseline, data on patients' demographic characteristics, comorbidities, previous~     peripheral interventions, medication, and clinical stage of PAD (Rutherford category),~     haemodynamic parameters, and procedural data including complications will be assessed.~      Major adverse cardiac and limb events will be recorded at planned (at six and 12 months) and~     at any unplanned visits.~      For details see NM Malyar et al., Rationale and design of the RECording COurses of vasculaR~     Diseases registry (RECCORD registry). Vasa. https://doi.org/10.1024/0301-1526/a000631~   "
9079|NCT03448016|"~     The goal of this study is to compare [C-11]NOP-1A binding in recently abstinent alcohol use~     disorders and controls~   "
9080|NCT03448003|"~     The goal of this research study is to develop a cancer prevention program for women who may~     be at risk for breast cancer and who do not have a regular diet, exercise, and stress~     management plan in place. The program will include dietary recommendations, physical~     activity, stress management and mindfulness training, learning sleep hygiene techniques, and~     behavioral counseling in addition to social support.~      This is an investigational study.~      Up to 60 participants will be enrolled in this study. All will take part at MD Anderson.~   "
9081|NCT03447990|"~     The purpose of this Phase 1 study is to evaluate the safety, tolerability, pharmacokinetics,~     and pharmacodynamics of MYK-491 in patients with DCM and stable heart failure.~   "
9103|NCT03447704|"~     BCD-085-5 is an International, Multicenter, Randomized, Double-blind, Placebo-controlled~     Clinical Study of the Efficacy and Safety of BCD-085. BCD-085 is a monoclonal antibody to~     interleukin 17. During BCD-085-5 trial patients with active ankylosing spondylitis will~     receive 120 mg of BCD-085 subcutaneously every other week or placebo up to Week 16. Starting~     from week 16 all patients will receive BCD-085. Efficacy, PK and safety parameters will be~     evaluated.~   "
9104|NCT03447691|"~     Investigators asses whether there is any difference in short term recovery and long term~     prognosis according to the anesthetic method in patients who undergoing pancreatic cancer and~     bile duct cancer and undergoing surgery for PPPD or distal pancreatectomy.~   "
9082|NCT03447977|"~     Neck pain which is common musculoskeletal system problem in all populations, negatively~     affects functional status and quality of life. Muscle spasms, postural problems in cervical~     and thoracic regions and impairment on respiratory parameters (respiratory functions and~     respiratory muscle strength) is seen with neck pain. Manual therapy and exercise are widely~     preferred in the treatment of neck pain for improve pain, posture, muscle strength, range of~     motion, functional status and quality of life.~      There are some studies showing that manual therapy improves respiratory parameters in~     pulmonary diseases but studies are lacking for neck pain. Our aim is to indicate that effects~     of manual therapy, manual therapy for different regions (cervical and/or thoracal region) and~     exercises for pain, posture, quality of life and also respiratory parameters in patients with~     chronic neck pain.~   "
9083|NCT03447964|"~     Sphingolipids are associated with metabolic diseases. Distribution of plasma sphingolipids in~     type 1 and type 2 diabetes has never been studied. The objective of the CERADIAB study is to~     compare plasma sphingoliplids concentrations in type 1 and type 2 diabetic patients.~   "
9084|NCT03447951|"~     This study is being performed to evaluate the efficacy and safety of 20% and 30% PTS100 of~     total tumor volume as intra-tumoral injection therapy in primary Hepatocellular Carcinoma~     patients who are ineligible for operation or local regional therapy.~   "
9085|NCT03447938|"~     MICS CABG (Minimally invasive coronary surgery), where coronary artery bypass grafting (CABG)~     is completed through a small incision over the left chest, has evolved to become a safe and~     less invasive alternative to conventional sternotomy CABG. Several observational studies have~     suggested significantly shorter time to return to physical activity for MICS CABG patients~     compared to sternotomy CABG patients. A randomized study is warranted to validate these~     findings, provide higher level of evidence, and potentially lead to changes in practice. The~     MIST Trial is a multi-centre, prospective, open label, randomized control trial comparing~     quality of life and recovery in the early post-operative period, between patients undergoing~     MICS CABG versus patients undergoing sternotomy CABG. Patients referred for isolated CABG for~     multi-vessel coronary artery disease and deemed technically suitable for sternotomy CABG as~     well as for MICS CABG are considered for enrollment into the trial. Quality of life~     questionnaires (The SF-36, Seattle Angina Questionnaire and EQ-5D-5L) will be used to assess~     the quality of life and recovery in patients undergoing sternotomy CABG or MICS CABG at 1~     month, 3 months, 6 months and 12 months follow up.~   "
9086|NCT03447925|"~     This study evaluates the addition of medicinal plant in the treatment of diabetic foot~     keratosis. Half of participants will receive medicinal plant and other half will receive a~     placebo.~   "
9087|NCT03447912|"~     This is a matched-pairs community randomized controlled trial (CRCT) to examine the impact of~     coalitions promoting smoke-free air policies on individual secondhand smoke exposure (SHSe).~      This proposal will build the capacity of Georgia (GE) and Armenia (AM) researchers to conduct~     high-quality mixed methods tobacco research and test the Community Coalition Action Theory~     (CCAT) as a framework for impacting local community-driven policy change to inform such~     processes for the region more broadly. Researchers from the GE National Center for Disease~     Control (NCDC) and AM National Institute of Health (NIH) will collaborate with Emory to~     execute the proposed research, train tobacco control researchers within their organizations~     and partnering universities, and train practitioners within local communities to build local~     coalitions for tobacco control policy.~      Twenty-eight communities (14 per country) will participate in the population-level tobacco~     survey at baseline and follow-up. Within each country, 7 communities will be randomized to~     the intervention condition and 7 to the control condition (14 communities per condition). In~     the intervention communities, public health center staff will form a coalition by recruiting~     partner organizations from civil society and other government sectors (e.g., health care,~     education), conduct situational assessment, and develop and implement action plans to promote~     the adoption and enforcement of smoke-free policies in worksites and restaurants, settings~     selected based on general support for smoke-free policies in these settings and the~     likelihood of impacting population-level SHSe through widespread reach. The GE NCDC and AM~     NIH will establish subcontracts with the local public health centers in the randomly selected~     communities to provide funding for local staff to develop local coalitions and to support~     program activities. The 14 communities assigned as controls will participate in the~     population-level survey and be provided with a site-specific summary of findings but will not~     participate in any aspects of the intervention. Additionally, to examine potential~     contamination in the control communities, a follow-up interview will be conducted with public~     health center leaders to assess any local coalition or grassroots actions regarding tobacco~     control that may have naturally occurred or be influenced by coalition activity in other~     communities.~   "
9088|NCT03447899|"~     Family dynamics and caregiver responses to a child with traumatic brain injury are implicated~     both as precipitating events as well as factors influencing outcomes of abusive head trauma~     (AHT). However, no family behavioral health intervention exists to meet the unique needs of~     families with infants and very young children with AHT. The study utilizes a randomized~     controlled trial (RCT) to assess the efficacy of an evidence-based behavioral intervention to~     improve outcomes for families and children with AHT. The investigators will examine outcomes~     in multiple dimensions, including clinical, cognitive, family, caregiver, child behavior, and~     service usage over time compared to patients not receiving the intervention. The~     investigators will then examine characteristics of patients and families that are best suited~     for this behavioral health intervention.~   "
9089|NCT03447886|"~     The overall goal of this study is to qualitatively explore how behavioral, cultural,~     psychosocial, and economic barriers and facilitators affect the decision to start and adhere~     to endocrine therapy (ET) among young breast cancer survivors of diverse racial, ethnic, and~     socio-economic backgrounds with hormone receptor positive (HR+) breast cancer~   "
9105|NCT03447678|"~     This is a prospective, monocentric, open label, phase II trial of intravenous (IV)~     Pembrolizumab monotherapy in subjects previously untreated for their stage IIIB-IV, PD-L1 low~     non small cell lung cancer (NSCLC).~   "
9106|NCT03447665|"~     While frequent night awakenings in newborns are common and expected, an estimated 20-30% of~     older infants and toddlers have frequent problematic night wakings requiring parental~     intervention throughout the night. Standard infant behavioral sleep intervention approaches,~     which require parental intervention throughout the night, are effective but often difficult~     for families to implement. The aim of this study is to compare the efficacy of two infant~     behavioral sleep interventions with a no treatment condition, on infant sleep and family~     functioning. Healthy infants between the ages of 6 and 18 months with night wakings will be~     randomized into one of three conditions: Entire night intervention, bedtime only~     intervention, or no treatment.~   "
9107|NCT03447652|"~     A randomized controlled trial investigating the effects of a 4-week ankle rehabilitation~     program on high school athletes with chronic ankle instability.~   "
9569|NCT03441581|"~     This study will evaluate the possibility of a differential effect of eluxadoline on altered~     bowel function in Irritable Bowel Syndrome with Diarrhea (IBS-D) patients with and without~     evidence of Bile Acid Malabsorption (BAM).~   "
9090|NCT03447873|"~     The persistence of an aberrant state of immune activation and inflammation (pIA) may~     contribute to the emergence of serious non-AIDS events which carry a higher morbimortality in~     HIV-infected patients. Although combined antiretroviral treatment (cART) reduces both~     cellular and soluble activation markers, it fails to completely control pIA despite~     consistent plasma viral load suppression. One of the mechanisms involved in pIA is may be an~     incomplete suppression of viral replication not reflected by plasma viral load, which only~     reflects a balance between viral replication and clearance of HIV-RNA. In addition, low-level~     viremia detected in most HIV-1-infected patients despite years on cART. Unintegrated 2-LTR~     HIV-DNA, and cellular associated HIV-RNAs, as products of active integrated DNA~     transcription, support this issue.~      Furthermore, the key rationales behind simplifying cART are a reduction of toxicities, lower~     risk of resistance mutations in case of virological failure and saving costs. One of these~     simplification strategies is a dual therapy which, based on the data up to date and in our~     clinical experience, has similar virological efficacy than cART. However, it is unknown if~     this strategy could increase the persistent HIV-1 replication and, therefore, pIA. The~     CD4+/CD8+ T cell ratio as a marker of immune recovery, the changes in T cell immune~     activation, senescence, exhaustion and apoptosis, and the cellular associated HIV-DNA and~     -RNA would answer the question if simplification to dual therapy would provide less control~     of residual HIV replication and, therefore, a detriment on pIA compared to triple therapy~     and, therefore, would worsen the patients' long-term prognosis.~   "
9091|NCT03447860|"~     The Primary objective of the study is to evaluate the effectiveness of mindfulness based~     caregiver intervention, Practice of Acceptance, Awareness, and Compassion in Caregiving~     (PAACC) compared to an established cognitive behavior therapy based dementia caregiver~     intervention, Resources for Enhancing Alzheimer's Caregiver Health (REACH) in improving~     caregiver burden and quality of life of care recipient.~   "
9092|NCT03447847|"~     Interventional crossover study on healthy volunteers aimed at evaluating the effect of the~     composition and timing of ingestion of different types of water on the urinary excretion of~     lithogenic substances; the study will also analyze the effect of potassium citrate on urine~     pH and lithogenic substances~   "
9093|NCT03447834|"~     In acute myocardial infarction, early restoration of epicardial and myocardial blood flow is~     of paramount importance to limit infarction size and create optimum conditions for favourable~     long-term outcome. Currently, restoration of epicardial blood flow is preferably and~     effectively obtained by primary percutaneous coronary intervention (PPCI). After opening the~     occluded artery, however, the reperfusion process itself causes damage to the myocardium, the~     so called reperfusion injury. The phenomenon of reperfusion injury is incompletely~     understood and currently there is no established therapy for preventing it. Contributory~     factors are intramyocardial edema with compression of the microvasculature, oxidative stress,~     calcium overload, mitochondrial transition pore opening, micro embolization, neutrophil~     plugging and hyper contracture. This results in myocardial stunning, reperfusion arrhythmias~     and ongoing myocardial necrosis. There is general agreement that a large part of the cell~     death caused by myocardial reperfusion injury occurs during the first few minutes of~     reperfusion, and that early treatment is required to prevent it.~      Myocardial hypothermia may attenuate the pathological mechanisms mentioned above. However,~     limited data are available on the beneficial effects of hypothermia to protect the myocardium~     from reperfusion damage. In animals, several studies demonstrated a protective effect of~     hypothermia on the infarction area. This effect was only noted when hypothermia was~     established before reperfusion. Hypothermia is therefore thought to attenuate several~     damaging acute reperfusion processes such as oxidative stress, release of cytokines and~     development of interstitial or cellular edema. Furthermore, it has been shown that induced~     hypothermia resulted in increased ATP-preservation in the ischemic myocardium compared to~     normothermia. The intracoronary use of hypothermia by infused cold saline in pigs was~     demonstrated to be safe by Otake et al. In their study, saline of 4°C was used without~     complications (such as vasospasm, hemodynamic instability or bradycardia) and it even~     attenuated ventricular arrhythmia significantly.~      Studies in humans, however, have not been able to confirm this effect, which is believed to~     be mainly due to the fact that the therapeutic temperature could not reached before~     reperfusion in the majority of patients or not achieved at all. Furthermore, in these studies~     it was intended to induce total body hypothermia, which in turn may lead to systemic~     reactions such as shivering and enhanced adrenergic state often requiring sedatives, which~     may necessitate artificial ventilation.~      In fact, up to now any attempt to achieve therapeutic myocardial hypothermia in humans with~     myocardial infarction, is fundamentally limited because of four reasons:~        1. Inability to cool the myocardium timely, i.e. before reperfusion~        2. Inability to cool the diseased myocardium selectively~        3. Inability to achieve an adequate decrease of temperature quick enough~        4. Inability to achieve an adequate decrease of temperature large enough~      Consequently, every attempt to achieve effective hypothermia in ST-segment myocardial~     infarction in humans has been severely hampered and was inadequate. In the last two years,~     the investigators have developed a methodology overcoming all of the limitations mentioned~     above. At first, the investigators have tested that methodology in isolated beating pig~     hearts with coronary artery occlusion and next, the investigators have tested the safety and~     feasibility of this methodology in humans.~      Therefore, the time has come to perform a proof-of-principle study in humans, which is the~     subject of this protocol.~   "
9094|NCT03447821|"~     To assess the safety and the preliminary efficacy data on the three doses of the new Cosmo~     Technologies oral rifamycin SV colon-release 200 mg tablets manufactured according to MMX~     technology (CB-01-11) in the treatment of infectious diarrhoea.~   "
9095|NCT03447808|"~     This phase Ib trials studies the side effects of daratumumab and ibrutinib and how well they~     work in treating patients with symptomatic chronic lymphocytic leukemia. Monoclonal~     antibodies, such as daratumumab, may interfere with the ability of cancer cells to grow and~     spread. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed~     for cell growth. Giving daratumumab and ibrutinib may work better in treating patients with~     chronic lymphocytic leukemia.~   "
9096|NCT03447795|"~     Alveolar bone resorption following tooth extraction is unavoidable. Graft placement following~     extraction is recommended when considering restorative procedures afterwards. The extracted~     tooth was considered a clinical waste. However, it is now seen as a convenient and available~     source for graft material. Different protocols are applied to process the extracted tooth for~     obtaining the graft material and investigations are needed to assess the protocol with the~     best outcome.~   "
9097|NCT03447782|"~     New daily persistent headache (NDPH) is a primary headache disorder characterized by the~     daily and unremitting headache pain patients experience with a distinct onset. Despite the~     known significant impairment associated with NDPH, the process by which some patients with~     NDPH recover within months while others do not is unknown.~      The investigators propose to refine the clinical definition and suggest a novel mechanism~     underlying new daily persistent headache (NDPH) in adolescents. In non-responding patients,~     they further aim to investigate low-dose naltrexone for the treatment of new daily persistent~     headache.~      Adolescents ages 10-17 will be recruited from Boston Children's Hospital Pediatric Headache~     Program.~   "
9098|NCT03447769|"~     The primary purpose of the study is to compare the efficacy and safety of canakinumab versus~     placebo as adjuvant therapy in adult subjects with stages AJCC/UICC v. 8 II -IIIA and the~     subset of IIIB (T>5cm N2 disease) completely resected (R0) non-small cell lung cancer~     (NSCLC).~   "
9099|NCT03447756|"~     This study is designed to identify a titration regimen of ABX-1431 in adults with neuropathic~     pain with satisfactory tolerability to central nervous system (CNS) adverse events (AEs).~     During the course of this study, each participant will take a daily dose of ABX-1431 or a~     matching placebo for 28 days.~   "
9100|NCT03447743|"~     The overall aim of this R34 proposal is to examine the feasibility, acceptability, and~     short-term outcomes associated with an innovative service delivery model to increase~     adherence to extended-release naltrexone (XR-NTX) during the transition from jail to the~     community for rural women with opioid use disorder (OUD). The significance of this study is~     grounded in the public health emergency associated with the opioid epidemic in rural~     Appalachia, the increased vulnerability of rural women with OUD, and the dearth of available~     and accessible evidence-based treatment in the region. This study has potential to make a~     significant contribution to the OUD treatment field by advancing knowledge on innovative~     service delivery models to increase access to evidence-based treatment to reduce the~     prevalence of opioid use disorders and related health disparities among hard-to-reach,~     high-risk, underserved populations.~   "
9101|NCT03447730|"~     This is a phase 1b/2a, randomized, double-blinded, placebo-controlled study to evaluate the~     safety, tolerability and pharmacodynamics of SYNB1020 in hepatic insufficiency and cirrhosis~     patients.~   "
9102|NCT03447717|"~     The aim of this study is to investigate the effects of the implantable drop foot stimulator~     ActiGait (Ottobock Health Care, Duderstadt, Germany) on gait in hemiparetic patients. While~     several studies investigated the effects of implanted systems on walking speed and gait~     endurance, only a few studies have focused on the system's impact on kinematics and long-term~     outcomes. Therefore, our aim was to further investigate the effects of the implanted system~     ActiGait on gait kinematics and spatiotemporal parameters with a 1-year follow-up period.~   "
9570|NCT03441568|"~     To investigate the safety and tolerability of the modified Diprobase formulation over 14 days~     in infants and children with a history of Atopic Dermatitis (AD).~   "
9108|NCT03447639|"~     Over the last decade, there has been great emphasis on reducing the incidence of~     hospital-acquired infections, including catheter-associated UTI (CAUTI). This study will~     evaluate the effectiveness of Betadine irrigation solution (2% povidone-iodine) instilled~     into the bladder immediately prior to indwelling catheter removal to decrease the risk of~     subsequent bacteriuria, leading to decreased rates of NHSN defined CAUTI.~   "
9109|NCT03447626|"~     The purposes of this investigation is to 1) To determine if Robotic-arm assisted UKA (RA-UKA)~     allows for more accurate component placement than manual UKA (MI-UKA)and 2) prospectively~     assess the learning curve, radiographic, and clinical outcomes of use of the RIO system as it~     is incorporated into our clinical practice and compare it to historical data on manual UKAs~     and TKAs.~   "
9110|NCT03447613|"~     To test the hypothesis that retinal nerve fiber layer (RNFL) thickness is correlated with Aβ~     and Tau concentration of cerebrospinal fluid (CSF) in an older population.~   "
9111|NCT03447600|"~     The aim of this study is to test the hypothesis that dietary weight loss (WL) through~     alternate day fasting (ADF) will enhance appetite control, health markers and wellbeing~     following WL compared to standard daily calorie restriction (CR).~   "
9112|NCT03447587|"~     A randomized controlled trial involving 140 subjects with (Diagnostic and Statistical Manual~     of Mental Disorders, Fifth Edition) DSM-5 insomnia disorder after excluding those with other~     medical conditions, psychiatric disorders, and sleep disorders that may cause insomnia. The~     subjects will be randomly assigned to either acupuncture treatment or sham acupuncture~     (control group) in a 1:1 ratio. The acupuncture treatment group will receive acupuncture~     treatments using a semi-standardized protocol. In a similar way, the sham acupuncture control~     group will receive acupuncture using validated non-invasive sham acupuncture needles. Both~     subjective (the sleep questionnaire and sleep diary) and objective (actigraphy) outcome~     measures will be recorded at baseline and at 1- and 5-week post-treatment. Fasting blood~     samples will be taken on the morning of the assessments at these time points to measure the~     oxidative stress parameters, including the malondialdehyde (MDA) level, and the glutathione~     peroxidase (GPx), paraoxonase (PON), and arylesterase (ARE) activities. The primary outcome~     is sleep efficiency, measured using a 7-day sleep diary and the oxidative stress parameters~     at 1-week post-treatment.~   "
9113|NCT03447574|"~     This study is designed to answer the question of if several non-invasive methods are~     comparable to the invasive clinical gold standard of radiolabeled albumin in terms of~     detecting changes in fluid volume.~      It is broken into two studies: Aim 1 Study A is designed as a pilot phase to develop the~     non-techniques, and Aim 2 Study B is comparing these techniques to the gold standard.~   "
9114|NCT03447561|"~     This study aims to disentangle the relative contribution of the anticipatory (food images)~     versus consummatory (food administration) component of dopamine release to food reward, by~     performing simultaneous Positron Emission Tomography (PET) and Magnetic Resonance (MR)~     scanning. Additionally, this study aims to assess the relationship of the dopamine release~     with (changes in) metabolic hormone levels.~   "
9115|NCT03447548|"~     Young people who are at great risk for developing psychosis have cognitive deficits which are~     strongly related to functioning in the community. This study looks to target a specific~     cognitive skill called processing speed to see if improving the ability to process~     information in a timely manner will improve social function in adolescents and young adults~     at risk for developing schizophrenia. Half will receive neurofeedback cognitive training~     targeting processing speed while the other half will receive an active control.~   "
9116|NCT03447535|"~     Oppositional Defiant Disorder (ODD) is defined in the Diagnostic and Statistical Manual of~     Mental Disorders, Fifth Edition (DSM 5) as: A pattern of angry/irritable mood,~     argumentative/defiant behavior, or vindictiveness lasting at least 6 months exhibited during~     interaction with at least one individual who is not a sibling. The disturbance in behavior~     is associated with distress in the individual or others in his or her immediate social~     context (e.g., family, peer group, work colleagues), or it impacts negatively on social,~     educational, occupational, or other important areas of functioning. Children with classic~     oppositional defiant disorder, except for mild forms, show symptoms in several settings (at~     home, at school, with peers).~      In this study, the investigators will consider the specifics of children presenting~     intrafamilial oppositional defiant disorder (IODD). These children's symptoms are confined~     to only one setting: the home. Therefore, the aim of this study will be to characterize~     children with intrafamilial oppositional defiant disorder. The investigators want to~     understand the differences between IODD and classical forms of ODD in terms of psychiatric~     comorbidities, medical histories and cognitive abilities. They also investigate what~     clinicians currently do to help these families.~   "
9117|NCT03447509|"~     The overall goals of this proposal are to examine the contribution of physiological pathways~     to the control of grasping behaviors after cervical SCI, and to maximize the recovery of~     grasping by using tailored non-invasive brain stimulation and acoustic startle protocols with~     motor training. The investigators propose to study two basic grasping behaviors, which are~     largely used in most daily-life activities: a precision grip and a power grip~   "
9118|NCT03447496|"~     Multi-center Study on Surgical Treatment for the Displaced JakobⅡ Classification Humerus~     Lateral Condylar Fractures in Children.~   "
9119|NCT03447483|"~     This trial is a multicentric, prospective cohort study of 150 patients aiming to model~     evolution of toxicity over time in patients with solid tumor and starting first cycle of~     Immune Checkpoint Inhibitor (ICI) treatment.~      The study will be conducted on a population of patients treated with ICI in the context of~     routine care. The follow-up during the treatment period and the clinical, biological and~     radiological assessments will be performed according to the standard of each centre.~      The study data (immune-related adverse events) will be collected during each administration~     of the treatment.~      A questionnaire will be completed by the patient before the treatment administrations.~      Patients will be followed until disease progression or up to 12 months of treatment.~   "
9120|NCT03447470|"~     The purpose of Part A of this study is to determine the safety and tolerability of RXC004 in~     patients with advanced malignancies. In order to define the doses and schedules for further~     clinical evaluation.~   "
9121|NCT03447457|"~     The aim of the study is to compare the efficiency on respiratory failure regression of~     high-flow nasal oxygen therapy versus standard oxygen in patients admitted to the ED for de~     novo acute respiratory failure.~   "
9122|NCT03447444|"~     Fronto lobe dementia constitutes 10-20 % of dementia conditions within younger persons (>65).~     People with neuronal degeneration in frontal and temporal lobes demonstrate a decline in~     social conduct, apathy, loss of insight that is gradual and progressive. Family members often~     experience guilt and shame because of the patients' behavior before institutionalization, and~     different behavioral disorders will cause great challenges to family caregivers and to staff~     after institutionalization. Preservation of dignity, both in regards to the person being~     affected, and their relatives, therefore seem highly relevant both before and after~     institutionalization.~   "
9123|NCT03447431|"~     MSI (Microsatellite Instability) colorectal cancer (CRC) show improved survival, are less~     prone to metastasis and show poor response to chemotherapy (compared to MSS tumors). The~     underlying reasons for these characteristics are still not understood and no specific~     therapeutic approach for MSI colon tumours (15% of CRC overall) has yet been developed.~      The MSI process is oncogenic when it affects DNA repeat sequences that have a functional~     role, e.g. Small Coding Repeats (SCR). MSI also frequently affects Long Non-Coding Repeats~     (LNCR) in tumour DNA. In contrast to SCR, only a few LNCR are endowed with biological~     activity. Consequently, this area has received very little attention. Our group recently~     identified HSP110 mutant chaperone protein in MSI CRC that was generated by somatic deletion~     of a LNCR. Of interest, HSP110 mutant (due to exon skipping) have anti-oncogenic properties~     and the survival of MSI CRC patients receiving chemotherapy is positively associated with~     HSP110 mutations in tumour DNA.~      The aim of the current project is to identify additional clinically relevant MSI-associated~     splicing aberrations due to mutations in LNCR located in splice acceptor sites. The four main~     steps are as follows:~        1. To identify exon/intron sites affected by aberrant splicing events due to MSI in CRC .~          All RNASeq data will be exploited to identify recurrent splicing aberrations (mostly~          exon skipping) that occur specifically in MSI colon tumours;~        2. To investigate for possible functional links between MSI and any detected aberrant~          splicing events . All specific aberrant splicing events detected by RNAseq in MSI CRC~          samples will be first confirmed (quantitative RT-PCR) in order to eliminate false~          positive cases. For validated exon candidates, the allelic profiles of adjacent intronic~          LNCR will be analysed (PCR and fluorescence genotyping) in CRC cell lines and primary~          tumours (MSI and MSS), as well as in matching normal mucosa samples in order to assess~          their polymorphic status;~        3. To identify splicing events and LNCR mutations with clinical relevance in MSI CRC~          patients . All LNCR with a confirmed role in gene splicing in MSI CRC will be analysed.~          The clinical relevance of candidate genes will be assessed using multivariate survival~          regression models for Relapse- Free Survival, with interaction terms (response to~          chemotherapy);~        4. To initiate functional studies on a limited number of clinically relevant,~          cancer-related genes whose splicing is perturbed in MSI cancer cells, and to develop~          biological tools to simplify screening in future clinical assays Similar to HSP110, we~          will focus on 4 or 5 mutant proteins that are promising drug therapeutic targets.~          Functional assays will be developed to further elucidate their role in the~          pathophysiology of MSI tumours. We also aim to develop biological tools for these~          candidate genes, such as the detection of wild-type or mutant proteins by~          immunohistochemistry.~   "
9124|NCT03447418|"~     This study is designed to establish reference values of multiple breath nitrogen washout~     indexes in an healthy population of volunteers (from childhood to adulthood)~   "
9125|NCT03447405|"~     Dino EGG mother's voice exposure and multisensory processing in Neonatal Intensive Care Unit~     infants.~      This is a 2 phase prospective comparative effectiveness trial of our parents' voice~     intervention with 290 hospitalized preterm infants.~      As a part of a previous project, an early technology development award from the Nationwide~     Children's Hospital (NCH) Technology Office allowed us to develop 10 functioning prototypes~     of the DINO EGG speakers, a NICU-safe and developmentally appropriate music player that~     delivers parent's voice to the bedside of NICU infants. The device passed NCH NICU-safe~     products committee and has been used in the clinical setting delivering clinical music~     therapy services (available at bedside to play parents' voice).~      The first phase of the current study is to test an updated prototype version of the device~     that replicates a previously FDA (and NCH NICU-safe products) proved device called Pacifier~     Activated Lullaby (PAL), used and described in IRB15-01035, but being discontinued by the~     company. The discontinuation is not due to safety or health benefits concerns. Therefore, no~     device available on the market currently exists to accomplish NICU parents' voice delivery in~     a consistent and safe manner, the investigators modified a 510K-approved feeding device that~     is no longer available and whose intellectual property rights have expired. The device's air~     displacement sensor, which fits into a standard NICU pacifier, allowed the investigators to~     deliver processed and developmentally appropriate recordings of parent's voice, contingent~     upon the infant producing effort to receive it. Intellectual property rights were filed for~     the modifications and use process through the technology transfer and legal office at NCH.~      Therefore, phase I will test the usability of the device (safety for the NICU was confirmed),~     not the effectiveness of the parents' voice delivery for the infant. Parent and nursing~     questionnaires about the importance of the device availability and its usability will be~     collected from parents and Registered Nurse (RN) staff that choose to provide the feedback.~   "
9126|NCT03447392|"~     Although interventions combining patient education and postdischarge management have~     demonstrated benefits in patients with chronic heart failure, the benefit attributable to~     patient education alone is not known. The investigators hypothesized that a patient discharge~     education program would improve clinical outcomes in patients with chronic heart failure.~   "
9127|NCT03447379|"~     •Prospective, open label, randomized, multicenter study~        -  Patients treated with a new generation of Everolimus-eluting stents (Synergy®). After~          PTCA, patients are randomized to a group of DAPT for one year or a group of P2Y12~          monotherapy after 3 months of DAPT. After 12 months of PTCA, evaluate major~          cardiovascular events and major bleeding events~        -  This study is to confirm after PTCA, DAPT for three months is not considered to be~          inferior to keeping DAPT for a year.~   "
9128|NCT03447366|"~     Interventional study of the accuracy of a non-invasive testing by echocardiography to predict~     respiratory worsening after vascular filling.~   "
9129|NCT03447353|"~     The aim of this research is to assess drug effects (Xanax and Norco) on driving performance.~     Researchers will use the Alertness Memory Profiler (AMP) application to compare results to~     previous related studies.~      This study continues a line of research designed to characterize the effects of common~     recreationally used prescription and illicit drugs with well known stimulant and sedating~     effects and their relationship to results from the Alertness Memory Profiler (AMP) that~     included a set of vigilance and memory tasks.~   "
9130|NCT03447340|"~     The proposed project will develop, implement, and test methodology for the design of an~     acceptable, effective intervention for diabetes prevention in a real-world setting. By~     determining the effectiveness of the intervention, the study will serve to guide the~     translation of research into routine public health prevention programs and policy. And, the~     hands-on experience will directly support the development of expertise, tools and training to~     advance translational science as a discipline. The study aims to test the effectiveness of an~     environmental and individual level intervention to prevent diabetes at Dhulikhel~     Hospital-Kathmandu University Hospital (DH-KUH), Nepal. Specific aims are to measure:~      Effectiveness of a canteen intervention on a composite score based upon improvement in 3~     cardio-metabolic risk factors (0-3) [HbA1c decrease ≥0.5%; a systolic blood pressure decrease~     (SBP) ≥5 mm Hg; and plasma triglycerides decrease ≥10 mg/dl] Effectiveness of a behavioral~     intervention on a composite score based upon improvement in 3 cardio-metabolic risk factors~     (0-3) [HbA1c decrease ≥0.5%; SBP decrease ≥5 mm Hg; and plasma triglycerides decrease ≥10~     mg/dl] Effectiveness of a canteen intervention on change in HbA1C and healthy food intake~     after six months of the canteen only (CO) intervention compared to the change over six months~     during the control period.~      Effectiveness of a behavioral intervention on change in Hba1c and healthy food intake after~     six months of behavioral intervention plus the canteen (CB) intervention compared to the~     change over six months during CO.~      We will recruit 366 adult employees of DH-KUH. At baseline (T1), 6 months (T2), 12 months~     (T3) and 18 months (T4), we will administer a standard questionnaire to record relevant~     characteristics of the participants (age, sex, education, income, marital status, and family~     history of CVD, physical activity, smoking, alcohol intake and diet). We will abstract food~     consumption data from the administrative database in DH-KUH. Blood samples will be collected~     and analyzed for HbA1c, fasting glucose, and lipid profile (HDL, LDL, total cholesterol,~     triglycerides). We will measure height, weight, waist circumference, hip circumference, and~     blood pressure. After 6 months of control period, the participants will receive the canteen~     intervention: (a) form and train a canteen improvement team; (b) train canteen staff on~     healthy cooking; (c) add healthy food and remove unhealthy food; (d) information and~     communication of canteen changes to employees; (e) monitoring of the interventions. After six~     months of the canteen intervention, half of the participants will be randomized to receive~     the behavioral intervention. The behavior intervention will be a combination of intensive~     education sessions, group counselling, goal setting and monitoring based on the Diabetes~     Prevention Program (DPP). The primary analysis will use χ^2test use to compare (a) Proportion~     of individual with score ≥ 2 during CO intervention to the proportion of individual with~     score ≥ 2 during the control period; (b) Proportion of individual with score ≥ 2 during CB~     intervention to the proportion of individual with score ≥ 2 during CO intervention. We will~     conduct a logistic regression with the proportion of individual with score ≥ 2 as outcome and~     CO vs CB as exposure at T4. Secondary analysis will use paired t-test to compare (a) the~     change in healthy food intake and HbA1c during CO to the change in healthy food intake and~     HbA1C during the control period (b) the change in healthy food intake and HbA1C% during CB to~     the change in healthy food intake and HbA1C% during CO period. We will conduct linear~     regression with HbA1c% as the outcome and CO vs CB as the exposure variable at T4. Further~     analysis will adjust for confounding in time-varying variables and assess effect~     modification.~   "
9131|NCT03447327|"~     Aim of the work: Is to evaluate the prognosis of single burr hole under local anesthesia in~     management of CSDH according to clinical picture, risk factors, and age.~   "
9132|NCT03447314|"~     GSK1795091 is being developed for administration in combination with other immune system~     modulators for the treatment of cancers. The combination of GSK1795091 and GSK3174998 will be~     evaluated for the first time in this clinical study.~   "
9133|NCT03447301|"~     Saudi Arabia has the highest prevalence (24%) of type 2 diabetes mellitus (T2DM) among the~     modern nation states in the world. In addition, majority of Saudi diabetic patient do not~     have their blood glucose controlled. Data suggests that diet, rich in olive oil and nuts,~     significantly reduces fasting plasma glucose and HbA1c (glycated hemoglobin). Olive oil has~     been associated with weight reduction as well as improvements in lipid profile (increase in~     high density (HDL) and decrease in low-density lipoprotein (LDL)). No randomized controlled~     trial has specifically examined the effect of olive oil as a supplement on blood glucose~     among diabetics. The study objective is to test the effect of daily consumption (30 mL) of~     extra-virgin olive oil (EVOO) on HbA1c among patients with type 2 diabetes.~   "
9134|NCT03447288|"~     Patients sedated under mechanical ventilation with acute hypoxemic respiratory failure with a~     PaO2/FiO2 equal or less than 200mmHg (Acute Respiratory Distress Syndrome, ARDS and non-ARDS)~     will be included in the study early in the course of the disease (first week of mechanical~     ventilation). At enrollment, data on the clinical condition of the patient will be recorded~     together with ventilation settings: ventilation mode, the fraction of inspired oxygen (FiO2),~     PEEP, tidal volume, set pressure, respiratory rate, time of the respiratory cycle, recent~     blood gas parameters.~      Airway pressure, flow, and esophageal pressure (or alternatively electrical activity of the~     diaphragm, Eadi) will be recorded 3 times a day for 7 days:~        1. Period 1 (morning): duration 20-30 minutes~        2. Period 2 (afternoon): duration 20-30 minutes~        3. Period 3 (evening / night): duration 20-30 minutes~      Registration will be ended at extubation, death or at eight days from the first recording.~      Monitoring of vital parameters (hemodynamic and respiratory) will be continuous throughout~     the duration of the study, as per normal clinical practice. All drugs used during the day of~     the measurements will be recorded. The patient will then be followed until discharge from the~     ICU and after 60 days of discharge to evaluate mortality.~      The analysis of the recorded waveforms will be performed in a single center by a centralized~     system that will quantify dyssynchrony and its intensity, calculate pressure time product,~     collect clinical and physiological data and outcome, and investigate possible correlations.~   "
9135|NCT03447275|"~     The objective of this study was to evaluate vitamin B deficiency (particularly vitamin B6~     deficiency) in diabetic patients in Germany in relation to the presence or absence of~     proteinuria, and global vascular risk.~   "
9138|NCT03447236|"~     Background: The Feuerstein Instrumental Enrichment Program was designed to prevent mental~     deterioration and preserve cognitive abilities among people aged 60 and above. The program is~     an applied practicable program based on the theories of Structural Cognitive Modifiability as~     well as on a Mediated Learning Experience. The program takes into consideration the unique~     characteristics and requirements of the older population. The program is composed of a~     variety of cognitive tasks that offer systematic activities intended to stimulate mental and~     cognitive development.~      Objective: To examine the influence of the Feuerstein Program on brain functional~     connectivity as measured by MRI assessments and cognitive function of participants suffering~     from Mild Cognitive Impairment (MCI).~      Hypothesis: The Feuerstein Program will improve cognitive abilities and affect brain~     functional connectivity.~      Methods: Residents of retirement homes will be offered to participate in the study.~     Participants will undergo cognitive and MRI assessments prior to and following a period of~     cognitive intervention using the Feuerstein Instrumental Enrichment Program.~   "
9139|NCT03447223|"~     Host-microbe interactions play a key role in brain development and function and in the~     etiology of neurodevelopmental disorders. Attention-deficit/hyperactivity disorder (ADHD) is~     a heterogeneous disorder that affects 1 in 20 children and results in poor life-time~     outcomes. However, the etiology of ADHD is unclear and its diagnosis and treatment are still~     challenging. Different factors reported to be associated with the risk of developing ADHD~     and/or linked to different ADHD manifestations have also been linked to shifts in gut~     microbiota composition, suggesting a link between the microbiota and the disorder. Here, we~     will perform a metagenome-wide association study and serum metabolomics profiling in a cohort~     of control and ADHD, 3-15 years, Chinese individuals. We aim to identify ADHD-associated gut~     microbial species linked to changes in circulating metabolites. We also aim to find the~     possible intervention strategy in ADHD by targeting the gut microbiota.~   "
9140|NCT03447210|"~     This study will determine whether assisted partner notification services (APS) can identify~     and link to care, the sexual and needle-sharing partners of HIV-infected and HIV/hepatitis C~     (HCV) co-infected persons who inject drugs (PWID). It will also define the risk factors for~     onward HIV and HCV transmission among PWID using viral phylogenetics.~   "
9141|NCT03447197|"~     Randomised controlled trials (RCTs) have shown high long-term patency for no-touch saphenous~     vein grafts (NTSVGs), comparable to the internal thoracic artery in on-pump coronary artery~     bypass grafting (CABG). RCTs on patency in NTSVGs in off-pump CABG have not been published~     yet. Orebro University Hospital participated in the CABG Off- or On-pump Revascularization~     study (CORONARY, ClinicalTrials.gov number, NCT00463294) and included fifty-six patients.~     Accordingly, this is a sub-study and the aim was to assess the midterm patency in NTSVGs in~     clamp-less off-pump versus on-pump CABG at five-year follow-up.~   "
9142|NCT03447184|"~     Until now no scientific clinical evidence exists regarding the possible impact of long term~     endogenous androgen priming in IVF patients aligned with the Bologna Criteria, in specific~     the impact of priming on serum parameters correlated with the ovarian reserve, antral~     follicle count, and the number of retrievable follicles. Thus, this pilot-study will explore~     a new suggested protocol for the Bologna criteria patient developed from basic physiology,~     and will if successful result in a subsequent randomized controlled trial in the same subset~     of patients, enabling a possible paradigm shift in the treatment of poor ovarian response~     (POR).~   "
9143|NCT03447171|"~     The objective is evaluation of GoCheck Kids, a smartphone application ('App'), for use as a~     photo screening device in a pediatric population to detect amblyopia risk factors (ARFs).~   "
9144|NCT03447158|"~     The main purpose of this study is to compare treatment efficacy of different concentration~     dextrose injection in chronic subacromial bursitis .~   "
9145|NCT03447145|"~     To identify the safety and tolerance of TQ-B3203.~   "
9146|NCT03447132|"~     This is a multicenter, international, double-blind randomized Phase III study to evaluate the~     pathological complete response (pCR) according to Chevalier classification between~     Fulvestrant® and the combination of Fulvestrant® plus Palbociclib as neoadjuvant therapy of~     hormone-sensitive patients with operable luminal breast cancer.~      Eligible patients will be assessed upfront using the OncotypeDX® molecular test (Recurrence~     Score <31).~   "
9147|NCT03447119|"~     The purpose of this proposal is to implement a joint project with Georgia Southern University~     and the Effingham County Navigator Team to improve the quality of life of families with a~     child with a disability in southeast Georgia. The final outcome of this project will be a new~     curriculum, Living Well Together, which builds on a previous implementation of the Living~     Well with a Disability curriculum in Bulloch County.~   "
9148|NCT03447106|"~     Gastric cancer is a common gastrointestinal tumor, and surgical operation is still the main~     method of gastric cancer treatment. Reported for the first time since 1994, the laparoscopic~     gastric cancer radical prostatectomy, laparoscopic technique is widely applied in the field~     of gastrointestinal surgery, has gradually replaced the traditional open operation as the~     main mode of surgical treatment for gastric cancer. Although laparoscopy has many advantages,~     there are still disadvantages, such as the discomfort of the physician, the reverse~     operation, and the ease of shaking, which hinder the application of laparoscopy. In recent~     years, the Da Vinci robot assisted gastric resection has become a new way to treat gastric~     cancer. Compared with the traditional laparoscopy and laparotomy, the operation of the robot~     is more precise and flexible, with obvious advantages of minimally invasive and good~     application value and prospect. The aim of the study is to compare value (outcomes/costs) of~     surgery in patients with Gastric Cancer by 3 approaches: open, laparoscopic, and~     robotic.First of all, the investigators will collect 500 cases of Gastric Cancer patients,~     randomly assigned for the open, laparoscopic, and robotic group. Secondly, to analyzing the~     demographic data,basic treatment and follow-up data, including the operation time, blood~     loss, the number of cut edge positive, the distances of cut edge away from the tumor edge,~     the cases of anastomotic fistula bleeding, stenosis, average such confinement, the meal time,~     cost of treatment, tumor recurrence rate, the presence of residual stomach, upset stomach and~     frequency, reflux esophagitis, bile reflux gastritis and other indicators.~   "
9732|NCT03439436|"~     An observer-blind, multi-centre, randomized, parallel-group study to compare the efficacy and~     safety of two formulations of xylometazoline/dexpanthenol nasal spray for the treatment of~     nasal congestion caused by an acute upper respiratory tract infection in adults.~   "
9149|NCT03447093|"~     Autoimmune thyroiditis (AITD) mainly includes Hashimoto's thyroiditis (HT) and Grave's~     disease (GD). Studies have shown that autoimmune thyroiditis is closely related to microbial~     disorders such as autoimmune thyroiditis However, there is no report on the relationship~     between oral microecology and autoimmune thyroiditis. Therefore, our group will study the~     correlation between oral microbiota and AITD.~   "
9150|NCT03447080|"~     bread and that rice-bran soymilk will have an additional beneficial effect on the glucose and~     insulin The proposed research project is important because it will provide, for the first~     time, evidence on the benefits of the addition of rice-bran to soymilk by measuring the acute~     effect on the glycaemic and insulinaemic response in co-consumption with a high GI meal in~     Asians. Investigators hypothesize that soymilk will lower the glycaemic and insulinaemic~     response of white response. This will have an important implication for public health as~     investigators will understand better how additional dietary fibre can improve the local diet~     which is typically of high GI values. Ultimately, results from this project will enable the~     development of dietary recommendations for better glycaemic control in Asian people.~   "
9151|NCT03447067|"~     in patent have deeply impacted lower third molar ,dose computer guided enhance surgical~     outcome versus conventional surgical remove of wisdom teeth~   "
9152|NCT03447054|"~     Most severe forms of alcohol-use disorder are thought to reflect an abnormal interplay~     between two neural systems: an overly active impulsive one driven by immediate rewards~     prospects and a weak reflective one, tuned on long-term prospects. The investigators propose~     that two non-pharmacological interventions, Transcranial Direct Current Stimulation (tDCS)~     and Inhibitory Control Techniques (ICT) may act on both systems when combined, which might~     ultimately result is a reduction of alcohol relapse rate.~   "
9153|NCT03447041|"~     This study is to inquiry the contrast sensitivity function in the 50 eyes of keratoplasty~     patients with quick contrast sensitivity function (quick CSF), as well the relationship~     between visual quality.~   "
9154|NCT03447028|"~     We investigate the association between Triglyserid-Glucose(TyG) index and prostate cancer in~     patients undergoing radical prostatectomy.~   "
9155|NCT03447015|"~     This study investigates the effect of ambulation (walking) during first stage of labour on~     maternal and neonatal outcomes. In the intervention group women will be encouraged to~     ambulate and women in the control group will receive usual maternity care.~   "
9156|NCT03447002|"~     Enhanced automaticity process is the underlying mechanism for arrhythmias due to excess~     catecholamines. Catecholamines may increase in patients with PVC. Metabolites of~     catecholamines are metanephrine and normetanephrine. Our aim is to measure 24 hours urine~     levels of metanephrine and normetanephrine.~   "
9157|NCT03446989|"~     Case management (CM) has been recommended as a way of inspiring measurable changes in~     individual behaviors and improving clinical outcomes for patients with chronic diseases.~     However, data on its effectiveness for Taiwanese patients with rheumatoid arthritis (RA) are~     limited. This study aimed to determine the long-term effectiveness of CM that focused on~     nurses' role among Taiwanese RA patients.~   "
9158|NCT03446976|"~     This study compares two administration methods of CT-P13. Half of participants will receive~     CT-P13 by pre-filled syringe while the other half will receive CT-P13 by auto-injector.~   "
9159|NCT03446963|"~     This study evaluates the feasibility of the Groups for Health (G4H) intervention for adults~     accessing support for depression in the UK. G4H targets improvements in adults' interpersonal~     functioning in order to reduce feelings of loneliness. The study will adapt the G4H~     intervention for delivery to adults seeking treatment for depression in the UK and estimate~     trial parameters (recruitment, retention, missing data and acceptability) of the adapted~     intervention, prior to a definitive trial. A mixed methods design of interviews and a single~     group, pre-post study will be employed.~   "
9160|NCT03446950|"~     The primary objective is to assess the impact of patient positioning using the candy cane~     stirrups as compared to boot stirrups on physical functioning outcomes at 6 weeks post-op~   "
9161|NCT03446937|"~     It will be a randomized controlled trial. There will be two study groups. Study group 1 will~     be given dexamethasone while study group 2 will be given betamethasone. The control group~     will be given placebo.~   "
9162|NCT03446924|"~     Ageing is characterized by a loss of muscle mass that is detrimental for physical function~     and metabolic health and increases the risk of mortality. The loss of muscle protein mass~     with ageing is characterized by a blunted muscle anabolic response to nutrition and exercise.~     Thus, interventions to counteract muscle anabolic blunting in old age might assist in the~     long-term maintenance of muscle mass.~      Phosphatidic acid (hereafter defined as 'PA') is a novel nutrient compound that has been~     suggested to play an important role in muscle growth. Oral consumption of PA may amplify the~     signalling response to nutrition and exercise and restore muscle anabolic sensitivity in~     older adults. In order for PA to be 'clinically' applied as a means to mitigate muscle loss~     in aged populations, we must first understand the efficacy and mechanisms underlying the~     anabolic properties of this compound, which have yet to be defined in man. The proposed pilot~     study is needed to investigate the acute muscle metabolic properties of oral PA~     supplementation in older individuals.~      Sixteen healthy (non-obese, non-diabetic, non-smokers) older males aged 65-75 yrs will~     initially complete a lower-limb strength assessment and undergo a body composition scan.~     Between 4-14 days after these initial assessments, participants will be assigned to co-ingest~     1.5g of either phosphatidic acid (N= 8; PA) or a non-caloric placebo (N=8; PL) after~     following a bout of moderate intensity, single leg resistance exercise. A stable isotope~     infusion will be combined with serial muscle biopsies from the thigh of each leg to determine~     the measure rates of muscle protein synthesis in the fasted state and in the 'early' and~     'late' phase of feeding-only and exercise-plus-feeding.~   "
9163|NCT03446911|"~     This study aims to evaluate the safety and mechanisms of action of the trimodality treatment~     (radiotherapy, immunotherapy and surgery) in early-stage non-small cell lung cancer. Half of~     the patients will receive stereotactic ablative radiotherapy followed by 2 cycles of~     immunotherapy (pembrolizumab); the other half will not receive the immunotherapy treatment.~     After treatment, both groups will continue treatment according to guidelines and will undergo~     surgery (lobectomy).~   "
9747|NCT03439241|"~     The purpose was to investigate the performance of a new ostomy device measured with a~     measuring device.~   "
9165|NCT03446885|"~     There has been little research on the third area of impairment noted in the Diagnostic and~     Statistical Manual of Mental Disorders - occupational functioning. Individuals with ADHD~     experience job-related impairments including a greater likelihood of being unemployed and not~     enrolled in school and for those that were employed they were in a lower status occupation,~     relative to typically-developing comparison peers. The current literature on analogue~     workplace settings and the effects of lisdexamfetamine dimesylate includes office-based tasks~     similar to school seat work. Unfortunately, this is inconsistent with the typical work~     environment most common for individuals with disabilities such as ADHD where food preparation~     is the most common job following high school. Therefore, medication effects in this type of~     setting, most common for individuals with ADHD entering the workforce, need to be studied.~     The investigators propose to study workplace behavior in an analogue work setting in a~     laboratory pizza place. Individuals with ADHD will participate in an interview with a~     supervisor each day, have a list of deliveries that need to be managed, deal with situations~     that require occupational judgment and appropriate customer service, and drive to make~     deliveries accurately and on-time. These behaviors can be reliably assessed within the~     laboratory. Twenty young adults will participate in two workdays within a randomized,~     double-blind, placebo-controlled design wherein participants will be administered placebo and~     .3 mg/kg lisdexamfetamine dimesylate in a counter-balanced order.~   "
9166|NCT03446872|"~     The purpose of this study is to characterize the safety of ONIVYDE when used under standard~     clinical practice in South Korea; and to describe effectiveness in patients receiving ONIVYDE~     in combination with 5-fluorouracil (5-FU) and leucovorin for the treatment of metastatic~     pancreatic cancer under standard clinical care in South Korea.~   "
9167|NCT03446859|"~     Dysmenorrhoea is a common problem in women of reproductive age. It is associated with painful~     uterine contractions and discomfort. The primary aim of the study was to determine the effect~     of Transcutaneous Electrical Nerve Stimulation (TENS) on pain intensity associated with~     primary dysmenorrhoea among female undergraduate students of Obafemi Awolowo University.~      The study involved 50 females undergraduates of Obafemi Awolowo University with primary~     dysmenorrhoea lasting for at least 5 days. They were allocated in to two groups equally. One~     group was treated with TENS and other group served as control. The treatment was for 5 days~     and Pain intensity was measured before and after the treatment in the two groups. The post~     treatment pain intensity was then compared.~   "
9168|NCT03446846|"~     MIN-117C03 is a 6-week, 3-arm, randomized, double-blind, placebo-controlled study to~     investigate the safety and efficacy of MIN-117 in male and female patients with Major~     Depressive Disorder, aged 18 to 65 years. Approximately 324 patients will be randomly~     assigned to 1 of 3 treatment arms, including placebo, 5.0 mg MIN-117, or 2.5 mg MIN-117 in a~     2:1:1 ratio.~   "
9169|NCT03446833|"~     The purpose of this study is to use local field potentials as control signals for adjusting~     DBS stimulation settings under varying patient states and to assess patient outcomes.~   "
9170|NCT03446820|"~     Thermal comfort and subsequent sleep quality will improve with the use of bedding that~     incorporates thermoregulation technology, in comparison to standard bedding products.~   "
9171|NCT03446807|"~     The purpose of this study is to determine the efficacy of Droxidopa for the treatment of~     fatigue in patients with Parkinsonism by the Visual Analog Fatigue Scale (VAFS). This is a~     randomized, placebo-controlled, double-blind clinical trial for 3 months where half the~     subjects will receive placebo and the other half will receive Droxidopa. Following this will~     be a wash-out period of 7 days and then all subjects will receive Droxidopa for 3 months~     during the open-label phase.~   "
9172|NCT03446794|"~     Atrial fibrillation (AF) is more common in patients with renal disease compared to the~     general population an risk increase to as much as 10 times in patients on hemodialysis (HD).~     Stroke is an important cause of morbidity, mortality and suffering for patients with~     end-stage chronic kidney disease (ESCKD) on hemodialysis.The risk of bleeding in these~     patients can be roughly 5-fold higher that without it. Current guidelines recommend the use~     of oral anticoagulants (AO) to prevent stroke or systemic thromboembolism in high-risk~     patients with AF. Left atrial appendage occlusion (LAAO) reduces the risk of bleeding while~     allows thromboembolic stroke prevention. The aim of the study is to assess the procedural~     safety on stroke and bleeding prevention of LAAC in patients with non-valvular atrial~     fibrillation (NVAF) and ESCKD on HD.~   "
9173|NCT03446781|"~     Subjects will be screened for study eligibility within 14 days prior to enrolling in this~     study. Subjects with 2 treatment areas (bilateral buttocks) with moderate or severe levels of~     cellulite as independently assessed by the subject using the Patient Reported Photonumeric~     Cellulite Severity Scale (PR-PCSS) and by the Investigator using the Clinician Reported~     Photonumeric Cellulite Severity Scale (CR-PCSS) will be eligible. The eligibility of the~     buttocks will be confirmed on Day 1. Once the eligibility of the buttocks is confirmed,~     subjects will be randomly assigned to a treatment group (EN3835 0.84 mg per buttock or~     placebo) in a 1:1 ratio within an investigational site. Each subject will receive a treatment~     course which consists of up to 3 treatment visits (sessions), separated by 21 days (ie, Days~     1, 22, and 43). Each treatment visit will consist of 12 injections (0.3 mL per injection of~     EN3835 0.07 mg/injection or placebo; 0.84 mg in 3.6 mL per buttock) in each of the two~     buttocks for a total volume of 7.2 mL (1.68 mg). Selection of dimples to be treated in the~     buttocks will be at the discretion of the Investigator. End of study will occur at study day~     71.~   "
9174|NCT03446768|"~     The O2VERLAP study investigators would like to find out if individuals living with both COPD~     and OSA would benefit from an online, educational curriculum, coupled with access to peer~     support (i.e. telephone and online chatting with peers) and remote CPAP adherence monitoring~     data. The curriculum and peer coaching is meant to provide participants the information and~     tools they need to be more compliant in using their CPAP device.~   "
9175|NCT03446755|"~     Patients suffering of subfertility as a consequence of intra uterine adhesions could be~     treated with adhesiolysis by hysteroscopy. Post-operative recurrent adhesions could be~     developed. To prevent these recurrent adhesions, an intra uterine balloon is inserted as a~     barrier. The investigator wants to test if the intra uterine balloon is a good alternative~     for the current used intra uterine device or gel.~   "
16644|NCT03349086|"~     The purpose of this study is to assess the effect of voice exercise and voice rest on~     subject's perception of vocal handicap and communicative participation following Botox~     injections for adductor spasmodic dysphonia.~   "
9176|NCT03446742|"~     Introduction: Despite the various beneficial effects, cardiovascular rehabilitation programs~     (CVRP) have been associated with the appearance of signs and symptoms. Risk stratification~     protocols are used to stratify into risk trials for an occurrence of events during physical~     exercise, although studies investigating their efficacy in predicting signs and symptoms~     during VCTV are inconclusive. In addition, several clinical, physical and biochemical~     parameters have been used in the literature as risk markers for the appearance of adverse~     events, and to investigate whether these parameters are capable of predicting a possibility~     of intercurrences during PRCV sessions.Objectives: 1) to evaluate the efficacy of risk~     stratification protocols in predicting signs and symptoms during the performance of a PRCV;~     2) to analyze the correlation between clinical, physical and biochemical parameters measured~     at rest with the presence of signs / symptoms in participants of a PRCV; 3) to evaluate~     whether changes in clinical, physical or biochemical parameters induced by PRCV influence the~     appearance of signs and symptoms during PRCV. Materials and Methods: To perform this study,~     data from 70 patients inserted in a PRCV will be evaluated. The study will be divided into~     three subprojects that can be divided into three stages: 1) risk stratification of patients~     who will participate in the study by two independent evaluators (Study 1) and evaluation of~     clinical parameters (cardiorespiratory parameters and autonomic modulation evaluation);~     (maximal isometric resistance, maximal isometric contraction, functional capacity and level~     of physical activity) and biochemical (IL-6, TNF-alpha and IL-10) (Studies 2 and 3). Patients~     will then be followed up by 24 sessions during the PRCV routines to evaluate signs and~     symptoms, for posterior correlation with the risk stratification obtained in each protocol~     (Study 1), and with resting values of clinical, physical and biochemical studies (Studies 2~     and 3); 2) Patients perform the normal routines of their PRCV for a period of 6 months (Study~     3); 3) The patients will again have their clinical, physical and biochemical parameters~     evaluated and then will be followed up for another 2 months (24 sessions) during the routines~     of the PRCV sessions to evaluate signs and symptoms, which will allow to evaluate if gains /~     losses in these parameters exert influence on the appearance of signs and symptoms during~     PRCV sessions.~   "
9177|NCT03446729|"~     The objective of this application is to pilot test and evaluate the acceptability and~     efficacy of a program to facilitate weight loss by enhancing memory for a recently consumed~     meal.~   "
9178|NCT03446716|"~     This pseudo-randomized intervention study examined change in inhibitory control following a~     sleep manipulation in which children with and without ADHD were instructed to advance their~     bedtime by 90 minutes for five days.~   "
9179|NCT03446703|"~     The present work consists of a randomized clinical trial comparing the effectiveness of two~     interventions based on social cognition training in outpatients with schizophrenia. The~     investigators sought to compare the effect of a targeted (TAR) and a broad-based (SCIT)~     intervention on schizophrenia patients' performance in facial affect recognition, theory of~     mind and attributional style. Secondarily, the investigators compare the effect on~     symptomatology, general cognition and functioning. The main hypothesis was that the patient~     group receiving TAR would exhibit a greater improvement in emotion recognition performance at~     the post-intervention assessment in comparison to patients receiving the SCIT, and,~     conversely, patients receiving SCIT would show more effect in ToM and attributional style. To~     assess the durability of these effects, performance in measures of social cognition, basic~     cognitive functioning, symptomatology and functional capacity were assessed before (T0),~     after treatment (T1) and 3 months later (T2).~   "
9180|NCT03446690|"~     The current study aimed to determine if MI Varnish has an effect in preventing the formation~     of white spot lesions for patients undergoing orthodontic treatment. 33 subjects were~     prospectively recruited for the project as the MI Varnish group, with a control group of 29~     orthodontically treated subjects who received routine treatment and oral hygiene~     regimes.Difference in prevention of white spot formation between the control and the study~     groups were evaluated through photographic records and clinical examination by using the~     Enamel Decalcification Index (EDI) scores.~   "
9181|NCT03446677|"~     Persons with HIV can present vestibular system impairments, affecting postural stability.~     There is scarce literature related to the contribution of the visual and somatosensory~     systems in maintaining postural stability in persons with HIV. The purpose of this study is~     to describe the sensory systems used to maintain postural stability and how the sources of~     sensory information contributes to postural stability in asymptomatic persons with HIV.~     Postural stability was measured in 20 asymptomatic persons with HIV (11 male, 9 female, aged~     43 ± 8 years). Static postural stability was evaluated during eight conditions that perturbed~     the visual, somatosensory and vestibular inputs. A paired-samples t-test was conducted to~     compare center of pressure (COP), antero-posterior displacement (APD) and right-left~     displacement (RLD) on stable and unstable surface and to characterize each balance sensory~     system. There was a significant difference in the COP and APD of eyes open condition compared~     to the remaining conditions on stable surface. Furthermore, there was a significant~     difference in the COP, APD and RLD for the eyes open on a foam surface compared to the~     remaining conditions on an unstable surface. Postural instability can be detected in~     asymptomatic persons with HIV under challenging conditions, previous to the evident~     appearance of balance impairments.~   "
9182|NCT03446664|"~     Evaluate the initial safety and effectiveness of Microburst VNS stimulation in subjects with~     refractory epilepsy.~   "
9183|NCT03446651|"~     The purpose of this study is to understand the effects of chloride supplementation on~     volume-overloaded acute heart failure patients concomitantly treated with IV diuretics.~   "
9184|NCT03446638|"~     This open-label, randomized, parallel group phase II study will investigate the efficacy of~     computational biology-informed treatment vs. standard of care treatment for patients with~     relapsed or refractory myelodysplastic syndromes (MDS).~   "
9185|NCT03446625|"~     Evaluation of resveratrol treatment oh ovarian hyperstimulation syndrome in egg donors~   "
9186|NCT03446612|"~     Daprodustat has demonstrated an ability to effectively raise hemoglobin concentrations with~     lower EPO levels than those observed after administration of rhEPOs. Therefore, daprodustat~     has the potential to treat anemia of CKD with a lower CV risk than is observed with the~     rhEPOs. While the effect of rhEPOs on endothelial function has been assessed, to date the~     effect of daprodustat or other prolyl hydroxylase inhibitor (PHI) compounds on endothelial~     function has not. Therefore, the purpose of this study is to compare the effect of~     daprodustat to darbepoetin alfa on endothelial function by assessing FBF in subjects with~     anemia of CKD by using venous occlusion plethysmography as a means to estimate the potential~     for daprodustat to have a lower risk of CV events as compared to rhEPO.~      This study will use a randomized, repeat dose, open label, parallel group design, in adult,~     not on-dialysis, male and female subjects with anemia of CKD that are currently not treated~     with rhEPOs.~      The study will comprise of three study periods: a screening period starting up to 30 days~     prior to Day 1, a 42 day (6 week) treatment period, and a follow-up visit up to 14 days~     later. The total duration of subject involvement is up to 14 weeks. Approximately, 50~     subjects will be randomized to either daprodustat or darbepoetin alfa.~   "
9187|NCT03446599|"~     This is a pilot study to determine the hemodynamic effects when hydroxocobalamin vs methylene~     blue is administered during cardiopulmonary bypass in patients at risk of vasoplegia by~     measuring mean arterial pressure (MAP), systemic vascular resistance (SVR) and vasopressor~     requirement.~   "
9189|NCT03446573|"~     The aim of the study is to establish if human immunodeficiency virus type 1 (HIV-1) infected~     adult participants with current virologic suppression on a ≥3-drug tenofovir alafenamide~     (TAF) based regimen (TBR) remain suppressed upon switching to a two-drug regimen of~     dolutegravir (DTG) 50 milligram (mg) + lamivudine (3TC) 300 mg. This study will also provide~     important information regarding the safety and participant satisfaction with this two-drug~     regimen. The primary objective of this trial is to demonstrate the non-inferior antiviral~     activity of switching to DTG + 3TC once daily compared to continuation of TBR over 48 weeks~     in HIV-1 infected, ART-experienced, virologically suppressed participants. This study also~     will characterize the long-term antiviral activity, tolerability and safety of DTG + 3TC~     through Week 100.~      This will be a 100-week, Phase III, randomized, open-label, active-controlled, multicenter,~     parallel-group study. The study will include a screening phase (up to 28 days), a randomized~     early switch phase (Day 1 up to Week 52), a randomized late switch phase (Week 52 up to Week~     100), and a continuation phase (post Week 100). Approximately 550 HIV-1 infected adults on~     stable TBR will be randomized 1:1 to switch to DTG + 3TC once daily for up to 100 weeks, or~     to continue their TBR for 52 weeks, at which time and if HIV-1 ribonucleic acid (RNA) <50~     copies per milliliter (c/mL) at Week 48, these participants will switch to DTG + 3TC up to~     Week 100.~   "
9190|NCT03446560|"~     Obstructive sleep apnea (OSA) is treated with a continuous positive airway pressure, so~     called CPAP. A new technology that enables telemetric monitoring of CPAP therapy. This study~     randomizes 560 patients to A) conventional follow up procedures or B to a telemedicine based~     follow up procedure. Main endpoint parameter is CPAP treatment compliance at 3 months after~     start of treatment.~   "
9191|NCT03446547|"~     This is a randomized multicentre open label phase II study of Durvalumab following~     Stereotactic Body Radiotherapy (SBRT) in patients with T1-2N0M0 NSCLC.~      Patients will be randomized 1:1 to follow up or receiving Durvalumab every 4th week for 12~     months~   "
9192|NCT03446534|"~     This study evaluates the effect of amoxicillin in the treatment of lower airway infections in~     preschool children. Half of the patients will receive amoxicillin, while the other half will~     receive placebo.~   "
9193|NCT03446521|"~     The immune system is impaired in liver cirrhotic patients, which is associated with a high~     risk for bacterial infections and worse outcome. A novel biomarker, acellular growth~     retardation ability (AGRA), can predict the development of severe infections in patients with~     liver cirrhosis and therefore identify patients at risk. It is still unclear, how this~     biomarker develops after liver transplantation and how valid its predictions are for~     post-operative infections. Therefore, AGRA will be measured before and after liver~     transplantation and predictive merit of AGRA for post-transplant infections will be tested.~   "
9194|NCT03446508|"~     This study is attempting to improve word finding and memory retrieval problems persons with~     mild cognitive impairment (MCI) may have.~   "
9195|NCT03446495|"~     This is a Non-interventional, Multicenter study evaluating the efficacy and safety of the~     combination of pegylated liposomal doxorubicin and trabectedin in routine practice in~     patients with recurrent partial-platinum sensitive ovarian cancer, which is held in~     Kazakhstan.~   "
9196|NCT03446482|"~     The evolution of the health care system in Western countries has increased the scope of the~     tasks assigned to doctors in their daily lives. The burden of administrative tasks and the~     use of IT tools reduce the time spent with the patient. Indeed, in a very recent work~     published in the Annals of Internal Medicine, Sinsky et al. showed that in 4 different~     specialties (general medicine, internal medicine, cardiology and orthopaedics) for every hour~     spent in front of a patient, each physician spent two hours on tasks in the absence of the~     patient1. This distribution of time was found in the Wenger et al. study in 36 internal~     medicine interns, since a ratio of 1:3 between the working time spent in the presence of the~     patient (1.7 hours) and that spent in front of a computer (5.2 hours) was noted2.~      The reduction in the clinical time devoted directly to the patient is a major source of~     dissatisfaction for physicians, which can even extend to burnout3. Moreover, it has been~     shown that the importance of computer tasks in everyday life is correlated with the~     occurrence of burnout4. Finally, beyond these clinical times directly or indirectly linked to~     patient care, the time spent on other tasks (administrative, travel time between different~     sites,...) appears to be significant (20% in Sinsky et al.)1.~      The anesthesiologist faces the same constraints as other specialties, but no work has been~     specifically concerned with the distribution of time spent on the different tasks. Compared~     to other specialties, anesthesiologist is also regularly confronted with specific~     organisational tasks within the operating room that could reduce the time spent directly with~     patients.~      The objective of this work is to determine the division of the different tasks in a~     anesthesiologist's work day by analysing the time spent directly with the patient but also~     that allocated to his or her care outside of his or her presence, as well as that devoted to~     organizational or administrative tasks.~   "
9197|NCT03446469|"~     Fascia is defined as the soft tissue component of the connective tissue system. It is a~     continuous mesh that has several functions such as maintaining structural integrity and~     providing support and protection. Ligaments are part of the dense connective tissue system.~      Studies conducted for ankle retinacula, which are thickened bands of fascia, also confirmed~     the presence of nervous tissue and proprioceptors within. Specific changes are seen in the~     MRI of ankle retinacula of individuals with chronic ankle instability. These changes include~     thickening of subcutaneous tissue. These structural changes may be responsible for~     interrupting the signals from the mechanoreceptors or also in damaging them.~      Since fascial manipulation can help reduce the densifications of deep fascia, it is possible~     that on restoring the original structural and material properties, the proprioception may~     improve due to clearer signals from the mechanoreceptors. For a normal individual, recurrent~     sprains may lead to occupational absence and difficulty with their ADLs. Hence, there is a~     need for this study to determine the influence of FM on chronic ankle instability.~   "
9198|NCT03446456|"~     The feeling of pain is not just a sensory experience, but is also influenced by emotions,~     beliefs and expectations, making pain a highly subjective experience. This is evident in~     clinical practice, where the behavior of the physician and the treatment context can strongly~     influence the pain experience of patients. Research has shown that patients' expectation that~     a treatment will reduce pain influences individual perception of pain, even if the treatment~     has no active ingredient. The expectancy-induced analgesia emerges due to a modulation of the~     individual pain experience of patients by an engagement of endogenous inhibitory systems in~     the central nervous system.~      The development of expectancy-induced analgesia can be generated in several ways. The~     investigators have previously demonstrated that social information and observational learning~     (e.g. the patient observes analgesia in another person receiving a treatment) can lead to~     expectancy-induced analgesia and pain reduction. However, the neural mechanisms (mechanisms~     in the brain) of how these expectancies are acquired and the neural mechanisms of analgesia~     induced by observational learning are unknown.~      The investigators recently established a procedure to investigate neural mechanisms of~     observational learning in placebo analgesia. Here the investigators propose to investigate~     the influence of vasopressin, a neurotransmitter that is important for social interaction, on~     observational learning.~      The investigators will use functional magnetic resonance imaging (fMRI), a non-invasive~     method, to investigate neural activity in humans. Participants will either receive~     vasopressin or saline with a nasal spray. During fMRI scanning, participants will then~     undergo an observational learning phase, where the study participants will learn the~     experience of analgesia in another person through a video, and a testing phase, where~     participants will perceive painful stimulations with the same cues as the observational~     phase. The comparison of the vasopressin group and the saline group will allow us to~     investigate how vasopressin influences behavioral effects of observational learning on pain~     perception as well as its effect on the neural processing of observational learning.~      A better understanding of how the human brain processes observationally-induced analgesia~     would allow us to improve the therapeutic context of pain treatments by increasing the~     contextual factors which help patients cope with pain.~   "
9204|NCT03446378|"~     In this study, it is wondered whether cortical excitability level could predict/direct the~     use of transcranial direct current stimulation combined with physical therapy on upper limb~     rehabilitation of post stroke patients. Furthermore, the study aims to correlate the motor~     recovery with cortical excitability level. For this purpose, after basal evaluation, patients~     will be classified according cortical excitability level in following categories: (i) mild:~     less than 4% of difference between lesioned and non lesioned hemisphere, evaluated with~     resting motor threshold measured by transcranial magnetic stimulation; (ii) moderate: more~     than 4% of difference between lesioned and non lesioned hemisphere, evaluated with resting~     motor threshold measured by transcranial magnetic stimulation; (iii) severe: non response of~     motor threshold measure in lesioned hemisphere.~   "
9205|NCT03446365|"~     Health disparities in pediatric asthma persist, with Latino children demonstrating increased~     asthma morbidity. Middle school children with asthma have greater morbidity than children~     from any other age group and spend a majority of their day in school, where they must manage~     any asthma. The investigators developed and piloted a novel group-based intervention - ASMAS~     (Asthma Self-MAnagement in Schools) in two geographic areas with a high prevalence of urban~     and Latino children with asthma: Providence, Rhode Island, and San Juan, Puerto Rico. ASMAS~     is a 4-session, peer-facilitated asthma self-management intervention specific to the school~     setting for Latino middle school (6th-8th graders) children. It is delivered by trained High~     School Juniors and Seniors of Latino descent with asthma. The preliminary effects of ASMAS~     for improving asthma outcomes and self-management relative to controls were demonstrated in a~     previous intervention development study. This study will evaluate ASMAS through a~     large-scaled Randomized Control Trial with urban middle school students who have persistent~     asthma in Providence, Rhode Island and San Juan, Puerto Rico and will identify barriers and~     facilitators to the implementation of ASMAS. These results will inform future, large-scale~     dissemination in other urban school settings.~   "
9206|NCT03446352|"~     The aim of present study is to analyze and compare the effect of two exercise programs -~     psychomotor exercise program vs exercise combined program (psychomotor + whole body~     vibration) - on risk factors for falls and falls occurrence of community-dwelling older~     adults who are fallers or are at high risk of falling.~      This experimental study is a randomized controlled trial. The program will run for 16 weeks~     (3 sessions / week of 75 minutes), followed by 8 weeks of follow-up without intervention.~     Participants will be assessed 1) at baseline, 2) at the end of the program, and 3) after the~     follow-up. Participants will be randomly allocated to three groups: experimental group 1~     (psychomotor program); experimental group 2 (combined program) and control group.~   "
9207|NCT03446339|"~     Pulmonary arterial hypertension (PAH) is a serious and often fatal complication of connective~     tissue diseases including systemic sclerosis and systemic lupus erythematosus. It has been~     reported primarily from European series that the prevalence of PAH in patients with~     connective tissue diseases particularly systemic sclerosis is as high as 15-20%. However,~     given the paucity of medical literature in the area from Chinese population, the prevalence~     of PAH amongst Chinese patients with these conditions is largely unknown. Even worse, PAH is~     often undiagnosed amongst patients with connective tissue diseases due to the lack of~     awareness and/or access to echocardiography, which is a non-invasive first-line screening~     tool for PAH. As a result, most patients at diagnosis of PAH are at a relatively late stage,~     rendering pharmacological treatment less effective. Here, the investigators propose a~     territory-wide pulmonary hypertension screening for patients with connective tissue disease~     in order to (1) detect pulmonary hypertension amongst patients with connective tissue disease~     through systematic screening, and (2) understand the prevalence of pulmonary hypertension in~     Chinese patients with connective tissue diseases.~   "
9208|NCT03446326|"~     The investigators will seek to determine the effects of different heart rates on both stroke~     volume and cardiac output using non-invasive hemodynamic assessments. In order to safely~     manipulate the HR, the investigators will study patients with permanent pacemakers in whom~     heart rate manipulation can be done in a safe and non-invasive manner.~   "
9209|NCT03446313|"~     The purpose of this study is to determine whether using a mobile app increases adherence to a~     heart healthy prescription after discharge from a cardiac rehab program.~   "
9210|NCT03446300|"~     High myopia retinopathy has become the first cause of irreversible blindness and severe~     visual impairment in Chinese adults, in order to avoid the blind and visual impairment caused~     by high myopia retinopathy, it is very necessary to research the mechanism of early visual~     impairment to prevent and control damages. Our recent research found that the decreasing of~     macular retina vascular density and subfoveal choroidal thickness, the increasing of Beta~     Zone area in optic atrophy and the rising of glycosylated hemoglobin in high myopia patients~     were significantly related to visual impairment, which suggested that the source of visual~     impairment was the abnormal structure changes surrounding optic and fovea, but so far there~     is no related study. We will conduct a 5 years prospective cohort study in the population of~     2420 high myopia and controls which have established in college student population, working~     population and aged more than 50 years old population, using the latest OCT-A and SS-OCT to~     measure macular retina vascular density, subfoveal choroidal thickness, Beta Zone area in~     optic atrophy, combined with the semiparametric mixed effects model, we will analysis the~     prediction index between fundus structure parameters, blood biochemical index and individual~     characteristics prediction to explore the public health management mode of early prevention~     and treatment during high myopia population.~   "
9211|NCT03446287|"~     This is a prospective, non-randomized, single center, data collection study of patients~     treated with open surgical repair (OR) for complex aortic aneurysms (CAAs).~   "
9212|NCT03446274|"~     This is a single-center, open-label, non-randomized, single dose of 14C-NW-3509 capsule study~     in 6 healthy male subjects.~   "
9213|NCT03446261|"~     To assess the efficacy and safety of rosuvastatin/ezetimibe combination therapy compared to~     rosuvastatin monotherapy in Korean patients with type 2 diabetes mellitus and~     hypercholesterolemia~   "
9571|NCT03441555|"~     An open-label, dose-escalation study to assess the safety and pharmacokinetics (PK), to~     determine the dose limiting toxicity (DLT) and the recommended Phase 2 dose (RPTD), and to~     assess the preliminary efficacy of alvocidib with venetoclax when co-administered in~     participants with relapsed or refractory (R/R) acute myeloid leukemia (AML).~   "
9214|NCT03446248|"~     This is a randomized controlled single blinded crossover study to compare fetal vibroacoustic~     stimulation with a handheld device to a mobile phone application designed for this study. The~     handheld device, the Corometrics model 146, was previously marketed and sold for fetal~     stimulation and is modeled after devices used as artificial larynxes. The mobile phone~     application uses an iPhone's built in vibration with acoustic stimulation from the speaker at~     2,000 Hz frequency at a sound level of 74 decibels when measured at 1 meter distance. The~     investigators' hypothesis is that the mobile phone application will elicit a fetal response~     (defined as one or more fetal heart rate accelerations in 15 minutes) at a similar rate to~     that of the handheld device.~      Fetal vibroacoustic stimulation is commonly used during antenatal tests of fetal well being~     such as a non-stress test. Fetal vibroacoustic stimulation works by arousing the fetus to a~     state of wakefulness during which reassuring fetal movements and associated fetal heart rate~     accelerations occur. During a non-stress test, two or more fetal heart rate accelerations in~     20 minutes constitutes a reassuring test. Fetal vibroacoustic stimulation has been shown to~     decrease the false positive rate of non-stress testing without increasing the false negative~     rate. This study will compare the frequency that one or more fetal heart rate accelerations~     occur in the 15 minutes after vibroacoustic stimulation with the Corometrics-146 fetal~     acoustic stimulator compared to after vibroacoustic stimulation with a mobile phone~     application designed for the study.~   "
9215|NCT03446235|"~     Many kinds of wearable technology have become available, but the superiority of those devices~     in weight loss compared to the standard care without them is uncertain. The possible problems~     are long-term self-motivation, utility and validity of the device, and outcome measures in~     clinical trials. The connected health care with motivational interviewing as an intervention,~     and body composition parameters in addition to body weight as outcome measures are employed~     in the project. The expected outcome is that connected health care, which is more~     individualized approach by heath care professionals, is more effective compared to~     self-monitoring using wearable devices. Two types of wearable device are going to be used to~     monitor 1) body activity and 2) heart rate variables during exercise which reflect fitness~     level in this study in order to investigate appropriate monitoring parameters to predict~     outcome measures.~      The hypothesis is that addition of connected health system will result in improvement of body~     composition and fitness level compared to self-monitoring.~   "
9216|NCT03446222|"~     This study will assess the efficacy of catheter ablation versus the Wolf Mini-Maze surgical~     ablation for rhythm control in patients with persistent afib.~   "
9217|NCT03446209|"~     Adult patients with Familial Mediterranean Fever, who have active disease~   "
9218|NCT03446196|"~     There are currently no clear recommendations on hemodynamic targets during kidney~     transplantation and most anesthesiologists rely on empiric or obsolete parameters such as~     CVP.~      The aim of this study is to investigate hemodynamic management of these patients applying a~     new generation of advanced monitoring systems such as MOSTCAREUP which can potentially~     provide a clear overview of the circulatory status beat by beat and to adjust fluid therapy~     in every single patient or clinical condition.~   "
9219|NCT03446183|"~     Investigating the short term smoking cessation on metabolism, examining of participant of~     smoking cessation workshops and former participants' file survey for metabolic aspects~   "
9220|NCT03446170|"~     The objective of this study is to examine whether cigarette packaging regulations including~     graphic health warning labels on cigarette packs and requiring plain, unbranded packaging~     reduce the appeal of cigarettes and prompt young adult smokers to quit.~   "
9221|NCT03446157|"~     This research study is designed to provide a better understanding of study drugs cetuximab~     (Erbitux®) and palbociclib when used in combination to treat patients with metastatic colon~     cancer.~   "
9222|NCT03446144|"~     The purpose of this study is to assess the Safety and Efficacy of IONIS-FB-Lrx for up to 120~     patients with Geographic Atrophy secondary to Age Related Macular Degeneration~   "
9223|NCT03446131|"~     This study will train War Fighters with lower extremity trauma to decrease fall risk.~   "
9224|NCT03446118|"~     Can an MRI detect and monitor the inflammatory and fibrotic possess in patients with~     Eosinophilic Esophagitis~   "
9225|NCT03446105|"~     This study expands on a prior pilot study to refine the intervention messaging to focus on~     goal-oriented thinking, include a coach, and extend the intervention to a larger sample of~     young adult cancer survivors (aged 18-39 years) recruited from two National Cancer Institute~     (NCI)-designated cancer centers (Emory's Winship Cancer Institute in Atlanta; University of~     Kentucky's Markey Cancer Center in Lexington). Participants will be randomly assigned~     (stratified by age and sex) to one of the 8-week treatment conditions in a 2:1 ratio (2 to~     intervention: 1 to attention control).~   "
9226|NCT03446092|"~     The study will investigate whether a mindfulness course can help people with incurable cancer~     who are seen by oncologists in a particular National Health Service Hospital Trust in the~     United Kingdom.~   "
9227|NCT03446079|"~     Demonstrate the relationship between single nucleotide polymorphisms (SNP) and response to a~     topical skin care product.~   "
9228|NCT03446066|"~     Cognition was assessed using Minimental state examination (MMSE), Trail making tests A and B~     (TMT) tests, P300 and quantitative electroencephalography (QEEG) sleepiness was assessed~     using Epworth Sleepiness Scale (ESS), Karolinska sleepiness scale (KSS) and QEEG also~     polysomnography (PSG) was done for all participated subjects~   "
9229|NCT03446053|"~     To evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of N-Rephasin®~     SAL200 following single and multiple ascending doses in healthy male volunteers after~     continuous intravenous infusion over 60 minutes.~   "
9230|NCT03446040|"~     The purpose of this study is to determine whether BMS-986258 both by itself and in~     combination with Nivolumab is safe and tolerable in the treatment of advanced malignant~     tumors~   "
9289|NCT03445273|"~     The MONET registry will include any patient with previous coronary stenting undergoing any~     type of surgery or operative endoscopic/endovascular procedure. The effects of the~     application of the Consensus Document Stent and Surgery-2 on perioperative antiplatelet~     therapy will be assessed. The study will also assess ischemic and hemorrhagic events in~     relation to the application of the Consensus Document and length of any antiplatelet~     discontinuation and delay in performing surgical procedures.~   "
9231|NCT03446027|"~     Intermittent claudication (IC) is caused by a blockage in the artery of the leg, causing~     muscle pain. Although some evidence of the efficacy of neuromuscular electrical stimulation~     (NMES) in the management of patients with IC exists, further high quality research is~     required. This proposed study is vital to identify the contribution of clinical change using~     NMES, compared to the current gold standard recommended practice of supervised exercise~     therapy (SET) and, actual standard of care offered in the majority of the UK and Ireland,~     including best medical therapy (BMT). The device is expected to increase the walking distance~     in patients with intermittent claudication (IC), and therefore have a benefit on the same~     when provided in addition to supervised exercise programmes. It is also expected to cause a~     reduction in pain symptoms and reduced likelihood of major intervention in late stage~     peripheral arterial disease (PAD). The principal research objective is to assess the clinical~     efficacy of a neuromuscular electrical stimulation (NMES) device as an adjunct to the local~     standard care that is available at the study randomisation sites, in order to improve walking~     distance in patients with intermittent claudication (IC).~   "
9232|NCT03446014|"~     The genetic contribution and influence on the progression of peripheral artery disease (PAD)~     and possible cardiovascular events remains relatively unknown. As a result, the investigators~     are proposing for the creation of a registry of patients in the University of Pennsylvania~     Health System who are known to have PAD. The patients in this registry will be systematically~     monitored by conducting lower extremity ultrasound exams, ankle-brachial index (ABI)~     measurements, and six minute walk tests which have strong value in the positive diagnoses of~     PAD. These exams, combined with follow-up quality of life questionnaires, would allow for~     thorough monitoring of new diagnoses, symptoms, or serious adverse events. Blood will also be~     drawn looking for genetic biomarkers associated with this disease, which will provide further~     knowledge on the advancement and potential cardiovascular events associated with this~     disease. This blood will also be analyzed for components that will provide the investigators~     with knowledge of the patients overall blood vessel health. Micro RNA will also be evaluated~     to try to test if proteins and RNA in the blood can be used as predictors for future strokes~     or heart attacks. These exams will be repeated once annually over a duration of 10 years,~     with patients having hemodynamic monitoring as well as quality-of-life and cardiovascular~     events recorded at each visit. The data obtained from this registry will be compared to a~     created genetic profile looking for any genetic contribution to these new developments.~     Furthermore, this knowledge should offer impetus for physicians to target patients with these~     risk factors for the identification of potential adjustments to care.~   "
9233|NCT03446001|"~     The purpose of this study is to determine the safety and efficacy of TRx0237 8 mg/day in the~     treatment of subjects with mild Alzheimer's Disease compared to placebo.~   "
9234|NCT03445988|"~     The proposed study will fill several critical gaps in evidence that are preventing patients~     and physicians from making informed decisions about their pain care. This project will~     provide patients taking opioids and physicians with the specific evidence they need to choose~     the most effective route to pain control, reduced pain interference, opioid reduction, and~     improved role function, thereby improving patient care.~      The aims of this study are to (1) reduce or contain prescription opioid use while maintaining~     pain control and (2) compare the effectiveness of the Chronic Pain Self-Management Program~     (CPSMP), Cognitive Behavioral Therapy for chronic pain (pain-CBT), and no behavioral~     treatment within the context of patient-centered collaborative opioid tapering (Taper Only).~   "
9235|NCT03445975|"~     A monocentric cluster-crossover design has been used in this study to test the effectiveness~     of a 3-in-1 perineal care washcloth versus standard of care (e.g., water and pH neutral soap)~     to prevent and treat pressure ulcers in ICUs.~   "
9236|NCT03445962|"~     The obstructive sleep apnea syndrome (OSAS) is frequently reported in subjects with trisomy~     21. The consequences of this syndrome are expressed in various disorders such as cognitive~     and cardiovascular alterations. It is also reported a premature exhaustion with the~     achievement of various professional or recreational activities, as well as an increase in the~     frequency of daytime sleepiness. In trisomy 21, there are factors that are systematically~     associated with obstructive apnea. The identification of these factors would make it possible~     to diagnose OSAS earlier, under-diagnosed in the population with trisomy 21 even though these~     OSAS are associated with increased cardiovascular risks.~      The aim of this study is to identify the predictive factors associated with sleep apnea in~     the trisomy population in order to propose early detection.~      OSAS treatment in a young adult with Down syndrome could reduce physical fatigue apparition~     during various activities, reduce daytime sleepiness, and have a positive impact on physical~     fitness, and therefore more broadly on health.~   "
9237|NCT03445949|"~     SAFE-LAAC Trial has been designed to gather data on the most optimal strategy of antiplatelet~     therapy after transcatheter left atrial appendage occlusion with Amplatzer Amulet device~   "
9238|NCT03445936|"~     This study compares a synthetic mesh and biological implant in prevention of incisional~     hernia after loop-ileostomy closure.~   "
9239|NCT03445923|"~     All patients starting an IVF-treatment at the clinics, and meeting the inclusion criteria,~     will be offered to participate in the study. Randomization will be performed on day 5 and the~     patients will be allocated into either morphology only group or time-lapse group. Embryos~     will be cultured to day five according to the clinics own routines. All embryos in both~     groups will be cultured using time-lapse incubation. In the control group the embryo~     selection will be based only on traditional morphological evaluation and in the treatment~     group a time-lapse selection model (KID Score day 5) will be used to select the embryo.~   "
9240|NCT03445910|"~     Despite recent advances in clinical and laboratory techniques of Assisted Reproductive~     Technology (ART), the pregnancy rate remains around 30% per cycle. It has been estimated that~     50% to 75% of lost pregnancies are due to failure of implantation.~      The process of implantation is a locally controlled paracrine/juxtacrine-mediated phenomenon.~     Successful implantation depends on the synchronized cross-talk between a functional~     blastocyst and a receptive endometrium. This process leads to apposition, attachment and~     invasion of embryos and subsequent normal placentation. So the objective of this study is~     investigate the impact of intrauterine injection of human chorionic gonadotropin (hCG) at the~     day of ovum pick-up on implantation and pregnancy rates in patients with recurrent~     implantation failure.~   "
9243|NCT03445871|"~     Methotrexate (MTX) is the first-line treatment of rheumatoid arthritis (RA). In case of MTX~     failure, it is discussed to start a Biologic Disease-modifying Antirheumatic Drug (bDMARDs)~     according to the latest European recommendations of the EULAR. Before to add a Biologic~     Disease-modifying Antirheumatic Drug (bDMARDs), an objective estimation of MTX impregnation~     could be carried out by MTX polyglutamates (MTX-PG). In rheumatoid arthritis patients with~     active disease estimated by DAS28 (Disease activity Score 28)> 3.2 insufficiently controlled~     by MTX subcutaneously and patients in remission obtained with a DAS 28 <2.6 with methotrexate~     prescribed since more than 6 months at stable dose for at least 3 months, a concentration of~     MTX-PG will be achieved.~   "
9244|NCT03445858|"~     This pilot study is designed to assess the safety, tolerability, and preliminary anti-tumor~     activity of the combination of pembrolizumab, decitabine and fixed-dose hypofractionated~     index site radiotherapy in pediatric and young adult patients with relapsed, refractory or~     progressive non-primary CNS solid tumors and lymphomas.~      Primary Objectives~        -  To determine the feasibility of administering pembrolizumab in combination with~          decitabine and hypofractionated index lesion radiation~        -  To identify the treatment-related toxicities and tolerability of the combination of~          decitabine and pembrolizumab~        -  To identify the treatment related toxicity and tolerability of the combination of~          decitabine and pembrolizumab with hypofractionated index lesion radiation~      Secondary Objective~      To preliminarily define the anti-tumor efficacy of the combination of pembrolizumab,~     decitabine and hypofractionated index lesion radiation in patients with relapsed, refractory,~     or progressive non-CNS solid tumors and lymphomas using overall response rate (CR + PR) by~     irRECIST after 3 cycles (1 block) of therapy.~      Exploratory Objectives~      To profile the kinetics of the immune response and to correlate with promotor methylation~     changes, nuclear imaging, stool microbiota diversity, and tumor associated antigen immune~     responses.~   "
9245|NCT03445845|"~     Axial spondyloarthritis (axSpA) is a chronic inflammatory disease characterized by~     inflammatory arthritis and enthesitis involving the spine. AxSpA prevalence is around 0.17%~     of the French population. Tumor necrosis factor (TNF) was the first target defined in axSpA.~     Since one third of axSpA patients failed to the first TNF blocker, many axSpA patients~     received a second biological Disease-Modifying AntiRheumatic Drugs (bDMARDs). Until few~     months, the only choice was to use a second TNF blocker.Since 2003, pharmaceutical companies~     investigated efficacy of TNF blockers already used in rheumatoid arthritis. Etanercept is a~     fusion protein with TNF receptor type II p75 and IgG1 Fc fragment, whereas adalimumab,~     infliximab, and golimumab are monoclonal antibodies. Certolizumab is a fusion between a fab~     fragment targeting TNF and a Peg fraction. All demonstrated efficacy versus placebo in a~     randomized double blinded study~      In case of failure to the first TNF blockers, rheumatologists will follow the~     Treat-to-Target principle. This approach already demonstrated its benefit in rheumatoid~     arthritis or in psoriatic arthritis. This concept was also suggested for axSpA with low~     levels of evidence and recommendation. So rheumatologist will provide the best treatment in~     case of failure to the first TNF blockers, which is a daily clinical situation. Since few~     months, rheumatologists have the choice between targeting IL-23/17 axis compared to a second~     TNF blocker.~   "
9246|NCT03445832|"~     This study aims to describe the evolution of pulmonary function in 3 neuromuscular diseases :~     Duchenne muscular dystrophy, Werdnig-Hoffinann disease, congenital myopathy, monitored in~     Besançon university hospital.~   "
9247|NCT03445819|"~     This is a multi-centre, randomized controlled trial comparing operative and non operative~     treatment for displaced patella fractures in elderly, low-demand patients.~   "
9248|NCT03445806|"~     The purpose of this study is to investigate how much trabeculectomy influences intraocular~     pressure (IOP) fluctuations measured with iCare Home rebound tonometry (RTHome) in patients~     with primary open-angle glaucoma (POAG) or pseudo-exfoliation glaucoma (PEX).~   "
9249|NCT03445793|"~     This study is a single center study of clinical and laboratory outcomes in patients ≥ 12 who~     transition from use of Orkambi to tez/iva. Clinical and laboratory measurements will be~     measured at baseline, 1 month, 3 months, and 6 months after initiation of tez/iva. The length~     of study participation will be approximately 6 months.~   "
9250|NCT03445780|"~     The purpose of this study is to evaluate the best distraction mechanism during trigger finger~     injection in the outpatient setting. Temporary discomfort from the needle prick is highly~     feared by patients and is often accompanied by significant acute pain and distress during~     routine corticosteroid injection in the orthopedic outpatient setting. This study aims to~     examine 4 different distraction methods and their efficacy in reducing perceived pain, which~     will be evaluate using the VAS (visual analog pain score.) The three distraction methods will~     be ethyl chloride spray, adjacent pinch, ethyl chloride spray and pinch, and screen or~     looking away method.~   "
9251|NCT03445767|"~     The older segment of the population is growing faster than any other segment. Older people~     have surgery more often than any other age group, and these older patients often take~     multiple medications, including medications that may result in more side effects (and risk)~     than benefit. Older patients who take multiple medications, and especially high risk~     medication, are more likely to die after surgery, and in those who survive, levels of~     disability are higher. For these reasons, testing a program that reviews the medications of~     older patients before surgery to decrease the use of dangerous medicines is very important.~      Most older patients in Ontario are seen in a preoperative anesthesiology clinic. Previous~     research has shown that this clinic visit is a teachable moment, where patients are more~     motivated to change their health-related behaviors. Therefore, the investigators propose to~     compare a structured medication review in the preoperative clinic to the usual care that~     people receive with the goal of decreasing the number and potential danger of the medications~     taken by older surgical patients. Recent systematic reviews have shown that no such programs~     have been tested to date in patients having surgery, so our findings will be unique. In~     addition, the investigators will also measure the impact of this program on people's health~     status, disability status, and use of healthcare resources (such as days in hospital) after~     surgery. If the investigators find that this single-center pilot randomized controlled~     designed study positively impacts these patient health outcomes, the investigators will~     perform a future multi-center cluster randomized trial of our intervention.~      MedSafer is a CIHR-funded Canadian software product that aids patients and physicians in~     deprescribing. It contains rules that identify potentially inappropriate medications (PIMs),~     prioritizes them in terms of risk of harm, and provides deprescribing opportunities for~     safely stopping medications using the current evidence as well as incorporating patient~     comorbidities in the analyses.~   "
9301|NCT03445117|"~     Pneumonia and influenza are among the top causes of hospitalisation and death in the elderly.~     While vaccinations are recommended against these diseases, a large proportion of elderly in~     the community remain unvaccinated, with approximately only 10% vaccinated for either disease.~     In this study, the investigators aim to implement an intervention package within GP clinics~     to increase influenza and pneumococcal vaccination rates, especially among elderly patients~     with chronic diseases.~   "
9252|NCT03445754|"~     Peripheral arterial disease (PAD) constitutes a major public health burden. The incidence of~     PAD increases with age and is associated with other comorbid cardiovascular disorders.~     Atherosclerosis which underlies PAD is associated with increased arterial stiffness and an~     enhanced inflammatory state as evidenced by increased levels of pro-inflammatory cytokines~     and markers. One the earliest signs of cardiovascular disease is endothelial dysfunction~     which is characterized by a decreased vasodilatory capacity of the vascular endothelium and~     this lesion predates the development of clinical atherosclerosis. Endothelial dysfunction has~     been shown to be widely prevalent in PAD. It is postulated that endothelial dysfunction is~     due to enhanced sympathetic drive, diminished parasympathetic drive, chronic inflammatory~     state all of which leads to reduced nitric oxide synthase activity in the vascular~     endothelium with subsequent loss of vasodilatory capacity. Studies have shown endothelial~     dysfunction to be reversible with pharmaco-therapeutic interventions, though these~     interventions are associated with their own adverse effects. Stimulation of Vagal nerve~     increases the parasympathetic activity while suppressing sympathetic drive, decreases~     inflammation and enhancing nitric oxide synthase activity. Recent experimental and clinical~     data suggest that low-level tragus nerve stimulation (by stimulating the auricular branch of~     the vagus nerve located at the tragus of the external ear) may produce the same desired~     neuromodulator effect compared to vagus nerve stimulation. It is however unknown if~     Transcutaneous Vagal Stimulation (TVS) would lead to improved endothelial function as~     measured by flow mediated dilatation (FMD) and laser speckle contrast imaging(LSCI), a~     non-invasive method of measuring endothelial function or decrease in arterial stiffness as~     measured by Pulse Wave Analysis (PWA), in patients with PAD. The objective of this study is~     to determine the impact of TVS on endothelial dysfunction as measured by FMD & LSCI and~     arterial stiffness. Study population will include patients with established diagnosis of PAD.~     After performing baseline FMD, LSCI and PWA patients will be randomized to TVS and sham~     stimulation with cross over. The patient randomized to TVS stimulation will obtain~     stimulation for 1 hour followed by measurement of FMD,LSCI and PWA. There will be a washout~     period of at least 24 hours with patient crossing over to the other arms thus serving as~     their self-control.~   "
9253|NCT03445741|"~     Objective: To show metabolic and hormonal responses and effects on abdominal obesity of~     aerobic exercise in different intensity and duration and detraining period in women with~     metabolic syndrome.~   "
9254|NCT03445728|"~     We compared the infarct and edema size in ST-segment elevation acute myocardial infarction~     (STEMI) patients undergoing primary percutaneous coronary intervention (PCI) treated by~     nicorandil before and after the reperfusion with those standard therapy treated by PCI~   "
9255|NCT03445715|"~     This study will evaluate the safety and tolerability of a single intra-articular~     administration of ART-I02 (AAV5.NF-kB.IFN-β), a recombinant adeno-associated virus (AAV) type~     5 vector in subjects with RA and active arthritis in the joint.~   "
9256|NCT03445702|"~     Metformin is associated with a high degree of gastrointestinal intolerance, which limits the~     effective use of the medication. It is proposed to be an inhibitor of liver mitochondrial~     glycerophosphate dehydrogenase which results in partial blockade of mitochondrial complex 1~     and inhibition of metabolism of lactate to pyruvate. There is also evidence that it is~     accumulated in gastrointestinal cells, and that there are certain genotypes associated with~     inclusion or lack of exclusion of the metformin from these cells. To validate this hypothesis~     investigators propose to give metformin after a standard meal test to see if there is the~     accumulation of lactic acid in those with gastrointestinal intolerance to metformin, compared~     to those without intolerance, and to determine if these elevations of lactic acid and GI~     symptoms are associated with genetic predispositions.~      Aims:~        1. To determine if the GI intolerance to metformin is associated with post meal elevations~          of lactic acid.~           a. The test will measure the inhibition of mitochondrial complex 1 levels of lactate to~          pyruvate compared with non- intolerant subjects.~        2. To determine if individuals with gastrointestinal symptoms and elevated lactate/pyruvate~          ratios have genetic variation in the organic cation transporters.~   "
9257|NCT03445689|"~     Premature infants present with significant oxygenation instability in the form of frequent~     spontaneous episodes of hypoxemia during the first weeks after birth. These infants are also~     exposed to hyperoxemia.~      The objective of this study is to determine the extent to which exposure to frequent episodes~     of hypoxemia and hyperoxemia in extreme premature infants during the early stages of their~     evolving lung disease is associated with altered maturation and function of their respiratory~     control system.~      This study is part of the Prematurity-Related Ventilatory Control (Pre-Vent): Role in~     Respiratory Outcomes Clinical Research Centers (CRC) (U01) cooperative program of the~     National Heart Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH).~   "
9258|NCT03445676|"~     Although little is known about compliance with the World Health Organization (WHO) 5 Moments~     of hand hygiene, the few existing studies report a high number of opportunities and~     compliance ranging from just 22 to 60%. Previous studies have reported an increased density~     of opportunities, perceived insufficient time and glove use as factors associated with~     non-compliance. A healthcare worker performing multiple tasks in one encounter may spend up~     to half the time in the room doing hand hygiene. Strategies to reduce the time required for~     hand hygiene may in turn promote increased compliance and may ultimately be most effective in~     limiting microbial transmission. In this study, the investigators examine whether cleansing~     gloves at each hand hygiene opportunity at the point of care and reusing the same gloves is~     as effective as standard practice and the current recommendation (remove gloves, perform hand~     hygiene, and don new gloves).~   "
9259|NCT03445663|"~     A multi-center Phase 1, First-in-Human study conducted in 2 Parts, testing AMG 424 in~     subjects with relapsed/ refractory multiple myeloma.~   "
9260|NCT03445650|"~     A Phase 3 Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Trial to Evaluate the~     Safety and Efficacy of ADX-102 1% Topical Dermal Cream in Subjects with Sjögren-Larsson~     Syndrome (SLS).~   "
9261|NCT03445637|"~     This non-interventional study is designated as a Post Marketing Surveillance Study and is a~     commitment to MFDS.~   "
9262|NCT03445624|"~     assessment of inflammatory bowel disease patients in activity and remission by abdominal~     ultrasound examine non-invasive and in physiological condition by measuring the colon wall~     thickness in diagnosis and follow up the patient also including extra intestinal features~     such as the splanchnic vessels,mesentery and lymph nodes . Doppler u.s can evaluate bowel~     wall vascularity In activity and remission . peripheral hemogram in relationship to activity~     inflammatory bowel disease asses anemia ,increase monocyte and decrease mean platelet volume(~     MPV) . also,the investigator will evaluate the outcome of different lines of treatment~     traditional and biologic therapy (response to treatment,times of activity and complications)~   "
9263|NCT03445611|"~     The purpose of this study is to identify whether corticosteroid use with anesthetics~     containing preservatives (parabens) reduces clinical effectiveness of the anti-inflammatory~     agent Up to 100 patients, both male and female, between the ages of 18-89 will be enrolled~     and randomized into either of the following groups; Group 1: These patients will receive a~     corticosteroid solution with lidocaine containing parabens.~      Group 2: These patients will receive corticosteroid solution with paraben free lidocaine.~   "
9264|NCT03445598|"~     This study is designed to evaluate a novel online tool to deliver computerized Cognitive~     Behavioral Therapy (CBT). Participants will be randomized into three groups: experimental,~     active control, and waitlist. Participants in the experimental group will have access to the~     full-featured online tool designed to deliver CBT in an interactive and personalized manner.~     The participants in the active control group will have access to a limited version of the~     online tool designed to deliver basic CBT in plain text format. The waitlisted participants~     will be put on a waitlist for 6 weeks. We hypothesize that the experimental group~     participants will show a significantly higher reduction in depression symptom severity and~     will show increased engagement and adherence to the online tool.~   "
9265|NCT03445585|"~     This study is a biobank of specimens and clinical data for use in current and future research~     to better understand the cholestatic liver diseases primary biliary cirrhosis/cholangitis~     (PBC) and primary sclerosing cholangitis (PSC).~   "
9266|NCT03445572|"~     The goal of this research study is to learn if meditation can help to improve cancer-related~     symptoms in hospitalized cancer patients. The meditative practices taught in this study are~     yoga based, but does not involve postures.~      This is an investigational study.~      Up to 90 participants will be enrolled in this study. All will take part at MD Anderson.~   "
9267|NCT03445559|"~     The primary aim of this study is to determine whether a multi-modal, physician-focused~     behavioral intervention can improve facility-level guideline-concordant utilization of~     prostate cancer staging imaging. Other aims of this study include to use mixed methods to~     explore physician influence on guideline-concordant imaging and to determine the cost and~     cost impact of a physician-focused behavioral intervention to improve guideline-concordant~     prostate cancer imaging.~   "
9268|NCT03445546|"~     Approx. 65% of resuscitated patients at the intensive care unit for internal medicine are due~     to myocardial infarction. Almost all patients are initially diagnosed and treated in the cath~     lab. Therapy usually consists of one or more stent implantations. After implantation of a~     coronary stent, dual platelet inhibition is necessary for 12 months. Insufficient platelet~     inhibition causes an pronounced increase in risk of stent thrombosis. Therefore, secured~     inhibition and knowledge of the individual platelet function is valuable.~   "
9269|NCT03445533|"~     A Phase 3 comparison of ipilimumab with and without IMO-2125 in advanced melanoma~   "
9270|NCT03445520|"~     In this study, the investigators will randomize 20 families per site (across 4 sites) to be~     in the BBB Transition Passport Only Group or BBB Intervention Group. Both groups will receive~     the BBB Transition Passport, which include the Transition Checklist, Student Snapshot,~     Parent/Caregiver Guide, and Student Guide. In addition to receiving the Transition Passport,~     the BBB Intervention Group will also receive coaching support to implement these resources.~     This coaching will include a member of the research team assigned as a coach for each family.~     This coach will introduce the resources to the family, briefly teach them fundamental~     information about the transition process, provide brief coaching phone calls, and guide~     parents in using the tools and requesting help from the child's provider(s).~      The investigators will be testing the differences between these two groups in terms of: 1)~     quality of the transition as reported by the parent and teacher, 2) self-efficacy of the~     parent during the transition process, 3) child school engagement and behavior during the~     transition as rated by the teacher and parent, and 4) the quality of the child's team to~     communicate about information important to the child's transition.~   "
9271|NCT03445507|"~     This study aims to evaluate the effectiveness of an intervention to help people to quit~     smoking throughout an chat bot compared with usual assistance to increase long-term rates of~     nicotine abstinence in smoking outpatients with biochemical validation at 6 months.~      Half of participants(control group) will receive usual care by their usual general~     practitioners and nurses, and the other half (intervention group) will use an evidence-based~     chat bot specifically designed to help people quit smoking.~   "
9272|NCT03445494|"~     The patient undergoes arthroscopic surgery to treat rotator cuff injury. At the end of the~     surgery, the patient will be randomized into group A (brace) or group B (normal sling).~      Both groups will be also treated according to standard of care with physiotherapy and~     progressive introduction of movements.~   "
9273|NCT03445481|"~     Patients with a trans-femoral amputation who experienced problems, complications pain due to~     the ischial weight bearing and discomfort with conventional socket prosthesis will be~     proposed to implant a new developed prosthesis.~   "
9274|NCT03445468|"~     The purpose of this study is to evaluate the immunogenicity and safety of 'IL-YANG~     Quadrivalent Seasonal Influenza Vaccine' in healthy Korean children and adolescents.~   "
9275|NCT03445455|"~     High Tidal volume is one of the main mechanisms that lead to lung injuries under mechanical~     ventilation (ventilator induced lung injury: VILI). It could also induce lung damage during~     spontaneous or assisted ventilation (patient-self inflicted lung injury: P-SILI). Different~     non invasive oxygenation devices are available to deliver oxygen during acute hypoxemic~     respiratory failure: high concentration mask, high flow nasal canula and non-invasive~     ventilation (with bucco-nasal mask or helmet). The investigators hypothesized that the device~     may influence the tidal volume. Therefore, the objective of this study is to measure and~     compare the tidal volume during the use of each device. Tidal volume will be measured using~     Electrical impedence tomography.~   "
9276|NCT03445442|"~     The investigator aimed to compare various pelvic floor repairs in female aged from 70 to 80~     years old, to see which procedure in terms of treatment-related complications of SCP, VMR and~     NTR by comparing the operative and functional outcomes in this patient population.~   "
9300|NCT03445130|"~     The purpose of this study is to determine the effects of lavender aromatherapy on~     preoperative anxiety by measuring changes in pulse rate and anxiety core using Spielberger~     State-Trait Anxiety Index questionnaires and on postoperative pain medicine usage. Study~     participants will then be randomized into one of four groups; either they will receive 2~     drops of lavender (Lavandula Angustifolia) oil (LO) or 2 drops of Michelia Alba Leaf oil (MA)~     or 2 drops of unscented Almond oil (AO) or two drops water on the inside of an oxygen face~     mask for 15 minutes. Linalool makes up ~30% of Lavandula Angustifolia oil and is believed to~     be its most active anti-anxiety component. Before and after treatment, anxiety level will be~     measured using the Spielberger State-Trait Anxiety Inventory.~   "
9277|NCT03445429|"~     Modern display technique seems to optimize visualization in minimal-invasive surgery. Many~     systems are available right now with a fundamental difference between the passive polarizing~     3-dimensional (3D) and 2-dimensional (2D) technique. Data seems to show a benefit for the 3D~     technique in the visualization of the operative field. This could lead to more precision in~     minimal-invasive surgery. 2D-systems with high resolution of 4.096 x 2.180 pixels (4K) could~     be a promising alternative. This study wants to evaluate if 3D- or 4K- display technique~     could optimize surgeons´ view and improve the performance during minimal-invasive surgery.~     Therefore medical students and surgeons of different experience levels will perform surgical~     tasks on a minimal-invasive training system.They will be randomized to use first the 3D- or~     the 4K-display system in the training set-up. After completing the tasks with one system the~     minimal-invasive training set-up will be repeated with the other display system. NASA~     (National Aeronautics and Space Administration) task load index is evaluated after each~     round. The ability for stereoscopic vision is tested after finishing the complete training~     set-up with both systems. The primary outcome parameter surgical performance will be~     evaluated in this study defined as the performance time and the number of defined mistakes~     made during each task.~   "
9278|NCT03445416|"~     Vaccine-preventable diseases such as hepatitis A and meningitis, as well as cancers caused by~     human papillomavirus (HPV) disproportionately impact young Black men who have sex with men~     (YBMSM). Traditional techniques of vaccination promotion have been unable to address the~     racial disparities in vaccination rates. One promising method for influencing behavior change~     within YBMSM networks is diffusion of information through Popular Opinion Leaders (POLs). The~     POL model engages persons who are leaders within their own networks/communities to promote~     behavior change. The objective of this project is to develop and pilot test a POL~     intervention to increase routine HAV, HPV and meningococcal conjugate vaccination among~     YBMSM, ages 18-26. research (PAR) framework to facilitate community support and ensure~     intervention strategies are salient. PAR includes community members as equal collaborators in~     the research process. Outcomes from these aims are expected to have an impact on health~     outcomes by identifying effective strategies for increasing vaccination and routine~     healthcare engagement among YBMSM.~   "
9279|NCT03445403|"~     Pediatric chronic pain disorders are common and consequential in Western societies, occurring~     in 25-80% of population-based samples with a median prevalence of 11-38% and significant~     pain-related disability in 3-5% of these children. Pediatric chronic pain disorders have a~     negative impact on many aspects children's lives including mobility, night sleep, school~     attendance, peer relationships, family functioning, and overall quality of life. Parents~     caring for these children risk loss of parental earnings, and these disorders place a high~     financial burden on healthcare. In a nationally representative sample in the United States,~     costs related to health care were significantly higher ($1,339 per capita) for children with~     chronic pain disorders compared to children with common pediatric health conditions of ADHD,~     asthma and obesity.~      In children with clinical chronic pain conditions, such as daily headaches or fibromyalgia,~     chronic pain is presumably a persistent state of an overly excitable nervous system. This~     phenomenon known as central sensitization is characterized by excessive pain sensitivity that~     occurs in response to non-painful stimuli, such as light touch or contact with clothing, and~     slightly painful stimuli, such as a light pinprick. This hypersensitivity results from~     peculiar changes in the working of the central nervous system, including the spinal cord and~     brain, and leads to unusual intensification of pain that is out of proportion to the inciting~     stimulus. For example, light touch from clothing on the skin is perceived as intensely~     painful. Central sensitization is also thought to contribute to the spreading of pain to~     other body sites in several chronic pain disorders.~      In chronic pain disorders, the function of the central descending inhibitory modulating~     system is likely impaired and is traditionally measured by a phenomenon identified as~     conditioned pain modulation (CPM) and more recently measured by a phenomenon of offset~     analgesia (OA). The OA test is more robust than the CPM test and likely more acceptable to~     most patients, especially children, because it is shorter in duration and uses a more~     tolerable painful stimulus. Compared to CPM, the OA test is more tolerable because it is~     conducted using a painful test stimulus that is less than the maximal (suprathreshold).~     Additionally, the time of exposure to the painful stimulus is significantly shorter, a few~     seconds, in the OA test compared to CPM.~      The central descending inhibitory pathway that modulates pain as tested by OA is functional~     and mature in healthy children as young as 6 year of age, but it has yet to be investigated~     in children with chronic pain disorders. The investigators plan to test OA responses in a~     population of common pediatric pain disorders with overlapping symptomology attributed to~     central sensitization (such as chronic musculoskeletal pain, chronic abdominal pain and~     chronic headaches and chronic regional pain syndromes) and compare their responses with an~     age- and sex-matched control group. The characteristics of OA responses in each group will~     allow for assessment of the presence or absence of central sensitization as a mechanism~     driving the persistent, abnormal pain in a subgroup of these chronic pain disorders. The~     investigators hypothesize that central sensitization is the potential contributory mechanism~     of the central nervous system heightened sensitivity to two testing stimuli of painful~     (moderate heat discomfort sensation) and non-painful (warmth sensation) in children with~     chronic pain disorders. These types of sensations mimic those that children would be expected~     to experience their natural environment during typical activities of daily living such as~     showering/bathing in warm water or hand washing.~      Additionally, the Pain Sensitivity Questionnaire (PSQ) and Central Sensitization Inventory~     (CSI) will be used as clinical screening tools for subjective report of sensitization~     symptoms, and are simple and easy to administer in a clinical setting. The investigators~     hypothesize that these measures will correlate with the objective offset analgesia responses~     thus allowing for assessment of central sensitization in children with chronic pain~     disorders.~      These tests are advantageous because they are feasible to perform rapidly in a clinic setting~     and have utility for measurement of patient responses to therapeutic interventions. If this~     concept is supported by this study, future studies could utilize OA to examine the effects of~     various pharmacological and physical interventions used to manage children with chronic pain~     disorders including intensive interdisciplinary rehabilitation or specific interventions such~     as aerobic exercise, which likely modulates pain via similar mechanisms.~   "
9280|NCT03445390|"~     The purpose of the study is to determine the efficacy of IV acetaminophen when administered~     to neurosurgical patients at the beginning and end of their surgery. If the result is~     improved pain control with less opioid consumption postoperatively, then those patients may~     also experience less opioid related side effects such as nausea/vomiting, pruritus, and~     sedation.~   "
9281|NCT03445377|"~     The main objective of this study is to determine whether real-time continuous glucose~     monitoring (CGM) for 8 weeks is more efficacious compared to self-monitoring of blood glucose~     (SMBG) in young adults with type 1 diabetes.~   "
9282|NCT03445364|"~     Percutaneous coronary intervention for myocardial infarction with ST elevation could be~     complicated with thrombus embolisation to the more distal segments of the culprit artery.~     Hypothesis - lower injection pressure could reduce the incidence of this complication. In~     this study the investigators compare two different protocols for dye injection - first one~     with higher and the second one with lower injection pressure.The impact of different pressure~     will be evaluated using the estimation of completeness of resolution of ST elevation as well~     as Myocardial Blush Grade on the end of the procedure. Patents will be followed for~     in-hospital mortality and MACE.~   "
9283|NCT03445351|"~     Aim: Evaluate the influence of exercise, in different times, on quality of life, sleep and~     clinical parameters in people living with HIV/AIDS (PLHA). Methods: Intervention study,~     prospective.~   "
9284|NCT03445338|"~     This is an open-label, multiple-dose study to evaluate the plasma and CSF pharmacokinetics of~     K0706 in healthy adult male subjects.~   "
9285|NCT03445325|"~     This study is the first of three sub-studies aimed at evaluating the outcomes of Living~     Green, Healthy for Teens (LiGHT v2.1), an app for 13 to 17 year -olds and their families that~     is intended to help them shift from an unhealthy lifestyle toward better health habits in~     three areas: physical activity, nutrition and sedentary behaviours. This first evaluation has~     the following aims to: 1) describe reach; 2) determine utilization/adherence to strategies~     implemented in the app and predictors of utilization/adherence; 3) assess change in knowledge~     and lifestyles behaviours associated with obesity as well as assess mediators of behaviour~     change. As this is a formative evaluation, it will prospectively follow 500 families for 4.5~     months.~   "
9286|NCT03445312|"~     This is an observational cohort study of 1000 consecutive patients on medical and surgical~     wards at the Mount Sinai Hospital in Toronto who have a mid-stream urine culture ordered.~     When these cultures are ordered or received in the laboratory, a message is posted that the~     specimen will not be processed in the laboratory unless a call is received to say that the~     patient has local urinary symptoms. The goal is to establish whether not processing~     mid-stream urine cultures is safe.~   "
9287|NCT03445299|"~     The study aims to evaluate the effect of listening to music at bedtime on sleep in elderly~     persons with dementia and sleep problems.~   "
9288|NCT03445286|"~     Gingivitis in the geriatric population is one of the growing global public health concerns,~     thus finding the most effective and non-invasive approach to prevent and treat gingivitis in~     the geriatric population is essential to prevent tooth loss and maintain oral health and~     function. Silver Diamine Fluoride (SDF) is Class II medical device. It was cleared for use in~     US August 2014 and became commercially available in April 2015. It is a chemical agent which~     has bifunctional properties. The silver itself kills caries causing bacteria directly. Silver~     and fluoride together interact to form fluorapatite in addition assist in hardening the teeth~     and preventing further demineralization.~      Even though, SDF has been approved in dental caries prevention and treatment, there are no~     published studies or evidence that evaluated the direct effect of SDF on gingivitis. If SDF~     improves or prevents gingivitis is unknown. The main goal of this clinical study is to~     investigate the effect of SDF on gingival status in geriatric patients with gingivitis. There~     is an urgent need to solve this common oral disease in the geriatric population. The logic~     for this research in a geriatric population is to find the most effective approach to treat~     gingivitis to prevent tooth loss and maintain oral health and function.~      To find an effective approach to treat gingivitis in the geriatric group, we will investigate~     the effectiveness of SDF application on gingival tissues in this group. The patients with~     gingivitis will be randomly allocated to two groups: group1(case group) will receive SDF~     application and group 2 (control group) will receive chlorhexidine (CHX) application. The~     gingiva will be evaluated for both groups at baseline before the application. Then 2 weeks~     and 4 weeks after the last application of the intervention. In addition, a sample of plaque~     will be taken from the teeth selected in this study by swab using dental kit (Ubiome) before~     and after both applications to quantify the presence of bacterial pathogen at baseline and~     follow up visits. The feasibility of this proposed therapy is supported by published~     literature that has shown that SDF was effective on dental and root caries prevention and~     treatment in geriatric patients.~   "
9290|NCT03445260|"~     This is a single-center randomized, placebo-controlled, double-blind feasibility study~     comparing the intervention of perioperative nutritional supplements (immunomodulation,~     carbohydrate loading, and protein isolate) with an identical placebo for each solution in~     patients with gastrointestinal cancer undergoing surgery. Eligible and consenting patients~     will be randomly allocated to receive the intervention or placebo in a 1:1 ratio.~      This study will assess the feasibility of a large, multi-centre trial by establishing the~     feasibility of randomization to intervention or placebo. This study will be conducted at the~     Juravinski Hospital and will enroll 100 patients over 18 months.~      The study intervention includes three perioperative nutritional supplements: (1) a protein~     supplement administered 3 times a day for 30 days before surgery, (2) a sugar-based~     supplement administered the day prior to and the day of surgery, and (3) a formulated liquid~     diet containing arginine, RNA, proteins and omega-6 fatty acids (referred to as~     immunonutrition for the purposes of this study) administered for 5 days prior to and 5 days~     after surgery.~      The primary outcome for each eligible patient is defined as being randomized to intervention~     or placebo. The criteria for success of this study is defined as the proportion of eligible~     patients randomized as ≥ 60%. If the estimated proportion is <40%, the trial will be~     considered not feasible. If the proportion is between 40%-59%, the trial will be considered~     feasible with modifications to improve enrolment. Other secondary objectives include~     compliance with study intervention, estimating differences in postoperative complications,~     length of hospital stay, and quality of life between groups.~   "
9291|NCT03445247|"~     In the current study, we use extracorporeal low-intensity shockwave therapy (ESWT) to treat~     on patients with type 2 diabetes in stage 3-4 chronic kidney disease and see whether it can~     improve the proteinuria, renal function, and blood pressure compared to baseline and control~     group.~   "
9292|NCT03445234|"~     The PURPOSE of this study is to investigate the combined influence of 2-weeks blueberry~     ingestion and banana ingestion (during exercise) on performance and in mitigating metabolic~     perturbation, immune dysfunction, and increase in inflammation following a 75-km cycling time~     trial. We hypothesize that the combination of 2-weeks ingestion of blueberries (versus~     placebo) and acute ingestion of bananas (versus water alone) during 75-km cycling will:~        1. Enhance performance.~        2. Attenuate the magnitude of metabolic perturbation due to exercise (using a targeted~          panel of metabolites) which may be associated with increased plasma levels of beneficial~          gut-derived phenolics.~        3. Attenuate post-exercise inflammation (as measured with cytokines, muscle damage markers,~          regulatory lipid mediators, ex-vivo monocyte cell cultures, and targeted immune proteins~          including S100A8 and S100A12).~        4. Counter post-exercise downturns in innate immune function (natural killer cell lytic~          activity), and viral defense (using an ex-vivo cell culture with Hela cells).~   "
9293|NCT03445221|"~     With the progress of cardiac surgery, the indication of cardiac valve replacement has been~     extended to include severely ill patients, even those with cardiac cachexia caused by~     long-standing mitral valve disease. Since patients with advanced cardiac functional~     disability are prone to fall into a low cardiac output state after valve replacement, Those~     severely ill, cachectic patients may be susceptible to postoperative acute renal failure.~     Preoperative malnutrition because of poor oral intake significantly increases the risk of~     adverse events after surgery and leads to increased length of stay.~      Major operation itself possibly cause the dysfunction of the host homeostasis, defense~     mechanisms and inflammatory response, which would increase the rate of postoperative~     complications and prolong hospital stay. Recently, many researchers argued that~     immunonutritional formulas supplemented with biologically active nutrients were more~     effective than standard nutrition intervention in improving inflammation, promoting the wound~     healing and shortening the length of hospital stay (LOS) after operation.~   "
9294|NCT03445208|"~     This is a study of experimental medication BMS-986036 given to healthy participants.~   "
9295|NCT03445195|"~     This study is a double-blind, randomized, placebo-controlled study to evaluate the safety and~     efficacy of IV ETX2514SUL in patients with complicated urinary tract infections (cUTIs) who~     are otherwise relatively healthy.~   "
9296|NCT03445182|"~     The aim of this study is to determine the effectiveness of DentalVibe (DV) in reducing~     injection pain and anxiety associated with local anaesthesia in paediatric patients.~      The clinical trial is a randomized split-mouth assignment. Included patients are 8-12 years~     old requiring local anesthetic infiltration with conventional syringe (CS) for extraction of~     two primary maxillary molars bilaterally. Eligible patients undergo two single-visit~     treatments after CFSS-DS measurement before each, where as DV is allocated to either first or~     second local anaesthesia procedure. Primary outcome measure will be pain felt during~     injection, reported by patient on VAS. Secondary outcome measures: self-reported anxiety~     during injection on FIS; pain-related behavior according to FLACC scale; heart-rate dynamics;~     patient preference to local anaesthesia method - CS or CS+DV.~   "
9297|NCT03445169|"~     This Phase 1, single-dose study will be conducted in adult male and female subjects (N = 16)~     who are in general good health and selected for participation in the study according to the~     selection criteria. This study will assess the effect of food on the pharmacokinetics of~     PT2977 Tablets. The study will consist of two periods and will be conducted in a crossover~     fashion.~   "
9298|NCT03445156|"~     The present research tests the effects of violent shooting games on behavior within the game~     (Pilot Study) and on behavior after the game is turned off (Experiment Proper). The~     Experiment Proper is an exact replication of a previous study conducted in our lab that was~     retracted (see citation), but with a larger sample to get more reliable results (N=287 rather~     than N=151).~   "
9299|NCT03445143|"~     The general purpose of the study is to determine whether yoga is an effective method for~     treating Generalized Anxiety (GAD), and its relative efficacy compared to a standard~     psychosocial intervention. This five-year multi-site study will examine the comparative~     efficacy of yoga, CBT, and stress education, a previously employed control condition, for~     patients with GAD. Across 2 enrolling centers (BU and MGH) 230 patients will be randomized~     with GAD to one of three 12 session weekly study treatments: 12-weekly yoga (n=95), CBT~     (n=95), or stress education (SE: n=40). Independent clinical assessments will occur before~     the 12-session intervention phase, at mid-treatment, after the intervention, and at 6-month~     follow-up. All clinician-rated outcomes will be assessed by trained Independent Evaluators~     (IEs) blind to treatment assignment.~   "
9302|NCT03445104|"~     This study evaluates the effects of acute huperzine A ingestion prior to exercise on~     cognitive function and perceived effort in exercise-trained individuals. Huperzine A has~     shown the ability to improve cognitive function in dementia patients, and is currently~     marketed as a cognitive enhancing supplement. Study participants will receive either~     huperzine A or placebo during the first experimental session, and will receive the other~     substance during the second session.~   "
9303|NCT03445091|"~     Clinical study to evaluate impact on quality of life in patients with Chronic Venous~     Insufficiency during 4 weeks period of using SANKOM® Patent Socks~   "
9304|NCT03445078|"~     Previous literature has found potential association between selenium deficiency and~     inactivated glutathione peroxidase and deiodinase, which may contribute to subsequent~     elevation of T4 and ratio of T4/T3. Conduction of a case-control study (ID: Liuyanping3) has~     been applied on Clinicaltrials.gov to further elucidate effect of selenium deficiency on~     thyroid function. Based on its data, the investigators will perform a randomized,~     placebo-controlled,single-blinded crossover study on 20 participants with selenium deficiency~     to verify health consequence of selenium.~   "
9305|NCT03445065|"~     This study will evaluate the usefulness of using a long term subcutaneously inserted~     continuous glucose monitoring (CGM) sensor in patients with insulin treated Type 1 or Type 2~     Diabetes Mellitus. The study will be conducted in France. Patients will be enrolled into two~     cohorts and randomized into two groups within each cohorts.~   "
9306|NCT03445052|"~     People with Xeroderma Pigmentosum (XP) have a genetic condition which stops their skin~     repairing damage from Ultraviolet Radiation (UVR). This means they are much more likely to~     develop potentially fatal skin cancers. The only way to reduce this damage is to rigorously~     protect the skin, by limiting UVR exposure. This done in a number of ways including: staying~     indoors; wearing protective clothing, sunscreen and glasses. People with XP can find it~     difficult to maintain this level of protection, putting themselves at risk.~      This research will test whether an intervention designed to enhance photoprotection~     activities is successful. It will use a randomised controlled trial design to compare the~     amount of UVR reaching the face, between participants receiving the intervention and those~     receiving standard clinical care. The amount of UVR reaching the face is important, as this~     is where people with XP develop most cancers. It is dependent on the overall level of~     exposure to UVR in the environment, and photoprotection used.~      The intervention involves a tailored conversation with the participant about their~     photoprotection practices. It will target both the overall exposure to UVR and the~     photoprotection used when outdoors, and will be conducted in 7 sessions with an intervention~     facilitator. The content will be dependent on the specific photoprotection behaviour being~     targeted (e.g., poor sunscreen application) and the reasons for poor photoprotection for each~     person. This could be low motivation related to doubts about the need to protect and concerns~     about protecting. Other barriers to protection might be lack of routines. The facilitator~     will provide information tailored to these beliefs and use other standard behaviour change~     techniques to encourage the development of better photoprotection habits.~      The investigators predict that the intervention group will have a lower mean daily dose of~     UVR to the face compared to the control group in two time periods in the summer months.~   "
9307|NCT03445039|"~     Background: Implant placement in the posterior maxilla is always troubled by the insufficient~     bone volume. Trans-alveolar sinus floor elevation (TSFE) has been proven a predictable~     surgical procedure to increase the bone height in the posterior maxilla. However, questions~     as the necessity of the bone grafting is necessary during the sinus lift and could the TSFE~     be performed when the residual bone height is below 5mm are still being debated. Besides,~     high-quality evidence on comparing the clinical outcome of transalveolar sinus floor~     elevation with osteotome and modified sinus floor elevation with crestal non-cutting drills~     is limited.~      Methods/Design: 120 adult patients who fit the inclusion criterions are being recruited from~     the first clinical division, School and Hospital of Peking University (Beijing, China). All~     the patients are assigned into four groups according a table of random numbers. Participants~     receive 1) TSFE using osteotomes with bone grafting; 2) TSFE using osteotomes without bone~     grafting; 3) modified TSFE with bone grafting; and 4) modified TSFE without bone grafting.~     The clinical operators will be concealed with the assignment until the beginning of surgical~     procedures. In a one year follow up period, implant survival rates, complications, implant~     stability, bone remodeling around the implant and patient-reported outcome (visual analogue~     scale for intraoperative discomfort and postoperative pain) are observed and documented. The~     implant stability is gauged by the resonance frequency analysis for 7 times (2,~     4,8,12,16,26,52 weeks). And the bone remodeling is observed and compared by CT scan.~      Discussion: The result of the trial will support a better decision making in atrophy~     posterior maxilla when implant placement is needed. If favorable, the use of the modified~     TSFE would achieve as ideal outcome as the traditional TSFE but with less trauma and~     postoperative discomforts. Besides, whether the bone graft procedure is necessary for the~     TSFE will also be discussed.~   "
9308|NCT03445026|"~     This study aims to provide information on the frequency of hypodontia in children cancer~     survivors receiving chemotherapy before 4 years of age.Patients who met the eligibility~     criteria will be given a structured questionnaire to fill followed by a radiographic~     examination (dental panorama) for confirmation and standardization of the results.~   "
9309|NCT03445013|"~     The objectives of this study are to assess the pharmacokinetics, pharmacodynamics, safety,~     and tolerability of SB414 in subjects with mild to moderate plaque psoriasis.~   "
9310|NCT03445000|"~     A research study to evaluate the activity of alectinib for the Treatment of pretreated~     patients with advanced NSCLC that have confirmed RETrearrangement.~   "
9311|NCT03444987|"~     Uterine fibroids (UFs), also called uterine leiomyomas or myomas, are steroid~     hormone-responsive, benign tumors of the smooth muscle compartment (myometrium) of the~     uterus. They are the most common neoplasm affecting women in their reproductive age. It is~     estimated that up to 77% of women develop UF in their life. UFs are one of the leading causes~     of hospitalisations for gynaecological disorders and are the most frequent reason for~     hysterectomy. According to relevant literature, 40%-60% of all the hysterectomies performed~     are due to the presence of UFs.~   "
9312|NCT03444974|"~     This study aims to investigate sociodemographic background of youth drug abuse, as well as~     psychiatric comorbidities with the help of self-report questionnaires and structured~     diagnostic interviews. The study simultaneously intends to evaluate long term cortisol levels~     in a single hair sample. Furthermore, three intravenous blood samples will be obtained from~     each participant in the course of the treatment in order to investigate substance related~     changes in immune and stress Systems, as well as methylation based changes associated with~     vulnerability and dependency.~      As the efficacy of currently available treatment options for addiction disorders is still~     unacceptably low, our study also aims to adapt, apply and evaluate new methods of treatment,~     such as a an adapted short term Matrix therapy for adolescents suffering from addiction~     disorders and their parents. Therapy outcomes, parental stress levels and learned skills will~     be evaluated.~   "
9313|NCT03444961|"~     The goal of the current project is to fill the unmet clinical needs around the objective~     assessment of visual function and develop outcome-oriented visual rehabilitation approach~     using the computer assisted rehabilitation environment (CAREN) system for Argus recipients.~   "
9314|NCT03444948|"~     To assess if endoscopic ultrasound-guided radiofrequency ablation application in patients~     with inoperable pancreatic cancer confers survival benefit when compared to patients~     receiving standard medical care.~   "
9315|NCT03444935|"~     This goal of this research is to examine the efficacy and feasibility of starting a phone~     call follow-up program for individuals discharged to the community after presenting to the~     Crisis Response Centre (CRC), a standalone mental health facility in Winnipeg, with suicidal~     ideation or behaviours. Currently there is no worldwide gold standard for how best to~     follow-up with individuals following presentations to health services with suicidal ideation~     or behaviours, despite the period immediately after discharge from mental health services~     being identified as a period of increased risk for death by suicide (Chung et al., 2017;~     Steeg et al., 2012). This risk is higher still for individuals who specifically had suicidal~     ideation or behaviours as a component of their reason for presenting to mental health~     services (Chung et al., 2017). One strategy that has been employed to mitigate this risk is~     brief contact interventions (BCI), which involves following up with people through text,~     phone calls, or written messages. Research has shown that this type of follow-up is~     well-received by individuals and although some studies have found this strategy reduces the~     rates of suicidal behaviours during this high-risk period, the overall literature shows mixed~     results (Miller et al., 2017; Exbrayat et al., 2017; Cebria et al., 2016; Milner et al.,~     2015; Morthorst et al., 2012; Fleischmann et al., 2008; Cedereke et al., 2002).~      Because the research on phone call follow up programs has been mixed, we will be conducting a~     brief trial to study the efficacy and feasibility of a phone call follow-up system in~     Winnipeg to inform whether or not this type of program would be of benefit to the community.~     In order to best study this, we will be conducting a randomized control trial for individuals~     who are discharged to the community after presenting to the CRC with a recent history of~     suicidal thoughts or behaviours. Participants will be randomized into either an intervention~     group or a control group. All participants will receive at least one and no more than five~     phone calls during the five-week period immediately following discharge from the CRC, and the~     content and timing of these phone calls will be different depending on which group a~     participant is randomized to. We will rely on both self-reported data, which will be~     collected in a formalized fashion, and data in the electronic medical records of participants~     to analyze this intervention. Our hypothesis is that the specific protocol we have designed~     to follow up with the intervention group will result in decreased suicidal thoughts and~     behaviours in the period immediately following discharge.~   "
9316|NCT03444922|"~     The National Institutes of Health has encouraged research examining effects of BPA, yet~     evidence in humans evaluating the effects of BPA on insulin and glucose concentrations~     remains exclusively associative in nature. Thus, the primary purpose of this study is to~     determine whether an acute oral ingestion of BPA impacts insulin and glucose concentrations,~     and other endocrine factors (Pro-insulin, C-Peptide, Estrogen, triglycerides). Findings from~     this pilot study will inform public health recommendations for food packaging and provide~     much needed experimental evidence as to whether BPA poses any public health risk.~   "
9317|NCT03444909|"~     The purpose of this trial is to create a comparative database, with data obtained with a new~     monitoring device of pregnant women,Toconaute, and a standard clinical cardiotocograph, It~     will allow to optimize the development of this new device.~      The use of the Toconaute will succeed to the usual monitoring of pregnant women with a~     cardiotocograph. It will not change their medical care.~      The trial will include up to 35 pregnant women between 24 and 41 weeks of amenorrhea that~     requires discontinuous monitoring. It will last about 12 months, with an estimated inclusion~     period of 11 month.~   "
9318|NCT03444896|"~     This study evaluates the efficacy and mechanism of acupuncture treatment in patients with~     subjective cognitive decline. Half of patients will receive acupuncture treatment for three~     months, while the other half will receive sham acupuncture treatment for three months.~   "
9319|NCT03444883|"~     The purpose of this study is to evaluate the efficacy and safety of Ilaprazole 20 mg in~     patients with non-erosive reflux disease. This study intends to demonstrate the clinical~     superiority of Ilaprazole 20 mg to placebo administered once daily for 4 weeks.~   "
9320|NCT03444870|"~     This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the~     efficacy and safety of gantenerumab versus placebo in participants with early AD. All~     participants must show evidence of β-amyloid pathology. Eligible participants will be~     randomized 1:1 to receive either subcutaneous (SC) injection of gantenerumab or placebo. The~     primary efficacy assessment will be performed at the end of the double blind period at week~     104. Participants will then be offered to enter into an open-label extension (OLE).~     Participants not willing to go to the OLE will participate in a long term follow-up period~     for up to 50 weeks after the last gantenerumab dose.~   "
9321|NCT03444857|"~     The aim of this randomized controlled trial to investigate the effects of CPAP treatment on~     myocardial salvage index and clinical outcomes at 3 months in patients with OSA and~     ST-Segment Elevation Myocardial Infarction (STEMI) after primary percutaneous coronary~     intervention (PPCI).~   "
9322|NCT03444844|"~     Whole body biodistribution and dosimetry with preliminary comparison to PSMA-11 in prostate~     cancer patients with biochemical recurrence~   "
9323|NCT03444831|"~     This study is a double-blinded Randomised clinical trial aim to compare buspirone plus~     omeprazole with placebo plus omeprazole.~   "
9324|NCT03444818|"~     This study will be conducted to evaluate the absorption, metabolism, and excretion of a~     single oral dose of [14C]-E6007 in healthy male participants.~   "
9325|NCT03444805|"~     The aim of the study is to assess the effectiveness of various post-transplant treatment~     management approaches on clinical and immune biological responses after Autologous~     Hematopoietic Stem Cell transplantation (AHSCT) for Systemic Sclerosis (SSc) as currently~     performed by the different treatment protocols used in routine clinical practice across~     Europe in various EBMT centres~   "
9326|NCT03444792|"~     obstetric hemorrhage remains one of the major causes of maternal death in both developed and~     developing countries. Because of its importance as a leading cause of maternal mortality and~     morbidity, and because of evidence of substandard care in the majority of fatal cases,~     obstetric hemorrhage must be considered as a priority topic for national guideline~     development.~      Some obstetricians believe that the cervix of women at non-labor cesarean section is~     undilated and might cause obstruction of blood or lochia drainage, leading to postpartum~     hemorrhage and endometritis from the collection of lochia or debris. Dilatation of the cervix~     helps with the drainage of blood during postpartum, reducing intrauterine infection or the~     risk of postpartum hemorrhage. To avoid this problem, some obstetricians routinely dilate the~     cervix from above during an elective/ non-labor cesarean section using finger, sponge forceps~     or other instruments~   "
9327|NCT03444779|"~     PMSI (French Medico-Administrative Database) data shows more than 10000 proximal tibial~     fractures diagnosed in 2014 and 4055 lateral tibial plateau fractures operated in 2013 in~     France. 50% of these fractures is related to the lateral condyle and causes split/depression~     (Schatzker 2) or pure depression (Schatzker 3). This high rate results from the recent~     democratization of high-risk sports, as well as an aging population with increased risks of~     falling. Aside from the resulting reduced physical activity, the social and professional~     impact of these fractures is undeniable and represents significant costs for our health care~     system. A recently published prospective case series reports 28 job losses out of 41 patients~     treated.~      The clinical outcome of these patients depends mainly on the primary stability provided by~     the surgical treatment, after the greatest anatomical reduction possible. Indeed, Giannoudis~     and al. have demonstrated that under simple X-rays, the smaller the detected step-off, the~     better the outcome.The aim is to allow for recovery of good joint mobility to promote rapid~     resumption of activity and to limit the onset of early osteoarthritis.~      The classical technique used for reduction and osteosynthesis of tibial plateau fractures~     (open surgical technique using a bone tamp) has several pitfalls : devascularization of the~     bone and skin, risks of infection and functional rehabilitation difficulties with delayed~     recovery of weight bearing. Moreover, this technique does not allow for the simultaneous~     diagnosis and treatment of other possible lesions, such as meniscal injuries in particular.~      Since 2011, Poitiers University Hospital is offering to its patients a new minimally invasive~     technique for the reduction and stabilization of tibial plateau fractures, baptized Tibial~     Tuberoplasty.~      The concept derives from the divergent use of vertebral kyphoplasty, initially dedicated for~     spinal injuries and transposed here to the tibial plateau. This technique involves expansion~     of the tibial plateau through inflation of a kyphoplasty balloon, filling of the created~     cavity with cement (PMMA, calcium phosphate) and percutaneous screw fixation.~      The first tibial tuberoplasties were performed through a feasibility study on 36 cadaveric~     subjects and then transposed the technique to human. Major advantages were identified such as~     minimal skin damage, possible treatment of posterior and multi-fragmented compressions~     (lifting in a single block by the balloon), reinforcement of the stability of the assembly~     using cement, possible use of combined arthroscopy (for concomitant meniscal injuries~     treatment).~      This technique allows for optimization of the fracture reduction by elevating the posterior~     fragments with the inflatable bone tamp through an anterior approach. The reduction is made~     possible thanks to the specificity of the inflatable bone tamp which inflates and reduces the~     area of least resistance.~      The aim of this innovative technique is focused on the anatomical reduction in order to~     restore the convexity of the tibial plateau which is similar to the balloon convexity.~      The results from the first 40 patients operated since 2011 are promising and show a~     proportion of 70% presenting less than 5 mm step-off reduction. A larger scale multicenter~     randomized controlled trial is now requested to further demonstrate the superiority of the~     Tibial Tuberoplasty to the standard treatment.~      This study was designed to evaluate the quality of tibial fracture reduction offered by~     percutaneous Tibial Tuberoplasty versus conventional open surgery for tibial plateau~     fracture but also its impact on clinical outcome.~   "
9328|NCT03444766|"~     This is a study of nivolumab in participants with advanced Non-Small Cell Lung Cancer or~     Kidney Cancer in India.~   "
9329|NCT03444753|"~     The purpose of this study is to determine whether BMS-986299 both by itself and in~     combination with Nivolumab and Ipilimumab is safe and tolerable in the treatment of advanced~     solid tumors. In addition, the ability of study drugs to stimulate an immune response against~     cancer will be investigated.~   "
9345|NCT03444545|"~     The capnodynamic method non-invasively calculates effective pulmonary blood flow (EPBF)~     continuously during surgery. In this study EPBF is compared to cardiac output (CO) measured~     with Transpulmonary Thermodilution (TPTD) att baseline and during hemodynamic changes in~     patients scheduled for open abdominal surgery at the Karolinska University Hospital, Solna,~     Sweden.~   "
9330|NCT03444740|"~     Our hypothesis that the prevalence of AD in uro-gynecologic patients with LUTS who are~     seeking medical help for their condition is higher than that of the general population~     (indicated by high scores at the ADNM-20; score above 48). Taking into consideration that~     affective disorders, anxiety and depression among patients with LUTS present with a~     prevalence of 17-23% [20] as well as through long personal experience, we hypothesize that~     the prevalence of AD in this group is 20%.~   "
9331|NCT03444727|"~     This study will compare pre-treatment with ice prior to injection of local anesthetic for~     vulvar biopsy to no pre-treatment and evaluate pain levels and patient satisfaction with the~     procedure.~   "
9332|NCT03444714|"~     This is a prospective, open-label, single arm, non-randomized study of RiMO-301 with~     radiation in patients with advanced tumors. A single escalation dose of RiMO-301 is~     intratumorally injected in a 3 + 3 study design to identify the recommended dose and dosing~     volumes.~      Condition or Disease:~      Patient with advanced tumor which is clinically accessible for intratumoral injection~      Intervention/Treatment:~      Drug - RiMO-301~      Radiation - Radiotherapy~      Phase:~      Phase 1~   "
9333|NCT03444701|"~     The primary objective of this study is to evaluate the tolerability and safety profile of~     E7130 in participants with advanced solid tumors.~   "
9334|NCT03444688|"~     The aims of this study is to test the training effects of the robotic walker. This study will~     compare the effectiveness of 2 different types of gait training protocols in chronic stroke~     patients, 1) conventional gait training (CT, control group), and 2) gait rehabilitation with~     the new walker modified after 1st stage (WT, experimental group).~   "
9335|NCT03444675|"~     The study validates prospectively a new endoscopic scoring system (Gothenburg Intestinal~     Transplant Endoscopy Score, GITES) designed to summarize and stratify the abnormal ileal~     endoscopic findings after intestinal transplantation. GITES is a five-tier, four grade score~     which asseses mucosal friability, mucosal erythema and mucosal injury (ulcerations) as well~     as villous changes according to severity. These features (i.e., endoscopic descriptors) are~     also grouped from mild to very severe in the same sequence as observed during the progression~     of several pathologic conditions encountered after intestinal transplantation (acute~     rejection, infectious enteritis).~   "
9336|NCT03444662|"~     The goal of this study is to determine the effects of Citicoline plus Omega-3 or Omega-3~     alone versus placebo on attention in non-demented healthy older adults.~   "
9337|NCT03444649|"~     This trial assess the maximum tolerated dose (MTD) and to characterize dose-limiting~     toxicities (DLTs) of epacadostat when added to the anthracycline/cytarabine combination as~     first-line induction treatment in AML patients fit for intensive treatment~   "
9338|NCT03444636|"~     The study was performed in patients aged 6-18 years after the Ravitch procedure and~     thoracotomy. The primary aim of the study was to evaluate the efficacy and safety of pain~     control provided by the multimodal approach that involves the continuous infusion ropivacaine~     with fentanyl vs. bupivacaine with fentanyl through thoracic epidural catheter. Secondary~     aims were to identify the determinants of acute post-operative pain at rest, during deep~     breathing and coughing.~   "
9339|NCT03444623|"~     Purpose: to examine the possibility of using the onco-protein survivin as a predictive~     biomarker for identifying individuals at risk of developing rheumatoid arthritis within a~     cohort of patients seeking treatment for joint pain/stiffness. Secondly, to study survivin as~     a prognostic marker for joint destruction, refractory and highly active disease in patients~     with established RA.~   "
9340|NCT03444610|"~     Blood transfusion is very lengthy procedure and consumes a substantial time from patients and~     health care providers. On average, it may take most if not all the working day which leads to~     significant constrains on hospital bed utilization. It starts from pre-transfusion testing,~     clinical assessment, actual administration of blood and post-transfusion care. The main bulk~     of this procedure is usually related to administration of the blood which typically given~     over 3 hours (5ml/kg/hour), although there is no strong evidence to support that. Indeed, it~     has been accepted as standard of care to transfuse blood over short time as in emergency~     situations.~      OBJECTIVE:~      To determine the maximum tolerated blood transfusion rate that can be safely delivered in~     patient who required blood transfusion i.e. transfusing blood over short time.~      METHOD:~      This is a phase I, open label, nonrandomized, prospective and rate-finding study. A~     well-known dose escalation design called 3+3 design will be used to identify the maximum~     tolerated rate. To assure the safety of such procedure, blood transfusion rate will be~     escalated very slowly by 1 ml/kg/hour for each cohort until rate-limiting toxicities or~     maximum of 10ml/kg/hour.~   "
9341|NCT03444597|"~     Post-Market Clinical-Follow-Up Study of Suprasorb® C collagen wound dressing~   "
9342|NCT03444584|"~     A Phase 2 study Comparing the effects on glucose control of Medi0382 in combination with~     Dapagliflozin and Metformin compared to placebo in combination with Dapagliflozin and~     Metformin in overweight/obese patients with Type 2 Diabetes Mellitus, Approximately 46~     subjects.~   "
9343|NCT03444571|"~     Implantation of joint prostheses is currently the second largest diagnosis-related group in~     the Danish health service, and in view of the demographic development and spread of lifestyle~     diseases, this type of intervention is expected to continue to increase.~      Unfortunately, 5% of patients experience significant discomforts and complications. The~     second most frequent and serious complication is infection. While the established laboratory~     analyses (culture of tissue biopsies) are good at diagnosing acute infections, they are not~     satisfactory to diagnose a large group of patients especially with chronic infections. This~     can lead to prolonged diagnosing time and even to wrong diagnosis.~      Several studies have shown that analyses of prosthetic parts and the use of molecular~     biological methods for detecting infecting microorganisms can significantly improve~     diagnostics accuracy.~      The purpose of this project is primarily to demonstrate that analyses of bacterial specific~     DNA (16S rRNA genes) can confirm or rule out infection as fast (or faster) as cultivation~     methods. Rapid clarification can promote targeted treatment and in order to demonstrate this,~     the trial is conducted as a randomized study. .~   "
9344|NCT03444558|"~     Clinical trial about beneficial effects of natural ingredient containing chlorogenic acid and~     luteolin on liver health and conditions related to liver (such as metabolic syndrome) for~     general body health.~   "
9347|NCT03444519|"~     Although mannitol is used for brain relaxation during neurosurgery and in the treatment of~     raised intracranial pressure; there is not a consensus on its safe, effective dose and the~     duration of its administration. This study aimed to compare the effects of the mannitol in~     different use times, on the brain relaxation, electrolyte, lactate levels of the blood,~     peroperative fluid balance and the volume of the urine in supratentorial mass resection~     surgeries.~   "
9348|NCT03444506|"~     A single-center, double-blind, placebo-controlled study of FDC olopatadine hydrochloride and~     mometasone furoate nasal spray (Molo; also referred as GSP 301) was conducted in subjects~     with seasonal allergic rhinitis. In this study, the efficacy and safety of two regimens (BID~     and QD) of the FDC (i.e. Molo 1 and Molo 2) were evaluated compared to placebo nasal spray,~     DYMISTA® and PATANASE®.~   "
9349|NCT03444493|"~     A gap of knowledge exists on the understanding of the acute effects of stabilization~     exercises on pain, disability and physical performance when applied after radiofrequency~     denervation. Therefore, the main objective of this study is to show the effects of~     stabilization exercises when started in acute period and also reduce the frequency of~     recurrence low back pain of patients with FJS after radiofrequency denervation.~   "
9350|NCT03444480|"~     The purpose of this study is to evaluate the Pharmacokinetics/Pharmacodynamics and safety of~     Remimazolam Tosylate in healthy volunteers after loading/maintenance dose regimen.~   "
9351|NCT03444467|"~     The study is comparing the new medicine NNC9204-1513 with a standard therapy of glucagon~     (GlucaGen®). This is the first time NNC9204-1513 is given to humans.~      Participants will either receive NNC9204-1513 or GlucaGen® - which treatment you get is~     decided by chance (like flipping a coin). Neither the participant nor the study doctor will~     know which study medicine (NNC9204-1513 or GlucaGen®) the participant is receiving (double~     -blinding). In case of emergency, this information will be readily available.~      NNC9204-1513 is a new medicine for rescue treatment of severe low blood sugar and currently~     not available on the market (doctors cannot prescribe this medicine). The participant will~     receive two or three single injections below the skin. One injection will contain~     NNC9204-1513 or GlucaGen®. The other injection will include placebo - this is a product that~     looks like the actual study drug but without any active ingredients. If a third injection is~     given, this will contain NNC9204-1513 or placebo. NNC9204-1513 and GlucaGen® will be given~     using different devices and volumes. In order to mask these external differences, a double~     dummy approach will be used, that means when you get either of the study medicine~     (NNC9204-1513 or GlucaGen®) you will get another injection which contains no medicine called~     'placebo' (it will not have any effect on the body). Dependent on the injection volume to be~     administered, injections are given by either syringe with needle or an injection pen (NovoPen~     Echo®). The study will last for up to 39 days.~   "
9352|NCT03444454|"~     The main aim of the study is to evaluate the efficacy of the Virtual Reality Rehabilitation~     System (VRRS, Khymeia) compared to usual care treatment for patients with MS at home. The~     effects of the intervention on outcome variables will be assessed using a randomized~     controlled trial design with a comparison group receiving usual care training. The~     investigators will assess the effect of VRRS system on the quality of life, motor, and~     cognitive abilities.~   "
9353|NCT03444441|"~     The present study investigates the minimal important change and validity of foot and ankle~     measures.~   "
9354|NCT03444428|"~     -  Patients with Motor Neurone Disease (MND) admitted to Lane Fox Unit /Royal Brompton~          Hospital and/or reviewed in Lane Fox Unit /Royal Brompton Hospital clinics and/or~          outreach review will be approached for participation in the study~        -  Physiological assessment and measurement of arterial stiffness will be performed in all~          patients at baseline and after the use of non invasive ventilation for 6 weeks.~        -  MND patients not requiring mechanical ventilation will serve as controls since non~          invasive ventilation cannot be withheld from MND patients in type II respiratory~          failure.~        -  Data will be analysed to look for differences between groups, relationships in baseline~          or change from baseline in respiratory physiological measures, inflammatory indices,~          breathlessness, and arterial stiffness.~             -  Age, Height, Weight~             -  History and Physical Examination~             -  Evaluation of dysponea: mMRC, Borg Scale (Seated-Supine)~             -  Amyotrophic lateral sclerosis functional rating scale (ALSFRS-R)~             -  Sleep Disordered Breathing in Neuromuscular Disease Questionnaire (SiNQ-5)~             -  24 hour blood pressure monitor~             -  Carotid-femoral pulse wave velocity~             -  Respiratory Muscle Strength - Maximal Inspiratory Pressure, Maximal Expiratory~               Pressure, and Sniff Nasal Inspiratory Pressure~             -  Spirometry - FEV1 and FVC~             -  Arterial Blood Gas~             -  CRP and fibrinogen (clinically)~             -  Breathe CO exhale~   "
9355|NCT03444415|"~     The main objective of this study is to evaluate the effect of an early and intensive~     intervention, based on techniques of effective counseling on healthy habits for parents, in~     order to reduce mean BMI at 2 years of age Secondly, the investigators will analyze the~     weighted increase of children's BMI, the eating habits of parents and children, duration of~     breastfeeding, physical activity level of parents and children and the children sleeping~     habits. In order to achieve it, the investigators have developed a randomized trial by~     Primary Care Centers, controlled by two parallel groups of study, open and multicenter study.~     The investigator team will recruit 414 pregnant women bwtween 12 and 16 weeks of gestation~     who will or will not receive an intervention, depending on their Primary Care Centers. The~     investigators will develop an intervention for parents, based on effective counseling~     techniques which are grounded on Motivational Interviewing approach with the objective of~     transmitting habits to reach a healthy lifestyle. The intervention consists in six workshops~     (90 minutes long), two prenatal and four postnatal, directed by professionals of the Field~     Researchers Basic Group (Family Practitioners, Pediatricians, Nurses and Midwives).~     Previously the field researchers will receive specialized training. This intervention will be~     compared to the usual model of care for children and women.~   "
9356|NCT03444402|"~     A Study to compare pharmacokinetics and safety of CKD-381 and D026 in healthy male subjects~   "
9595|NCT03441230|"~     There is a clear need for a novel method that can readily assess gastric motility in daily~     clinical practice. Isometric determination of the stomach motility would avoid the use of a~     large flaccid balloon while still being affordable. The aim of this study was to determine~     the optimal balloon characteristics that enable to measure motility-induced pressure changes~     in healthy volunteers.~   "
9357|NCT03444389|"~     The objective of this study is to examine the relationship between hemorrhoids, a common~     complaint, and the use of smartphones, also a common feature of modern life, in the lavatory.~      As is known, hemorrhoidal disease is a frequently observed disease of the lower rectum and~     anal region that seriously impairs the patient's quality of life.~      Based on clinical observations, the study investigators have found that the use of mobile~     phones in the lavatory has become a habit for some people. The investigators surmise that~     this habit, which increases the time spent on the toilet, also leads to an increase in~     pressure on the anal region and straining during defecation. There is a gap in the literature~     investigating the relationship between these two situations (smartphone use in the lavatory~     and the development of hemorrhoids). The basic research question of the present study is thus~     designed to determine to what extent the use of smartphones increases time spent in the~     lavatory and whether there is an association between this increase in time and hemorrhoidal~     disease.~   "
9358|NCT03444376|"~     A Multi-Center, Open-label Phase Ib-II Trial of the Combination of GX-188E Vaccination and~     Pembrolizumab in Patients with Advanced, Non-Resectable HPV-Positive Cervical Cancer~   "
9359|NCT03444363|"~     This study aimed to investigate the effects of diode laser (DL) in addition to non-surgical~     periodontal treatment on periodontal parameters, systemic inflammatory response, and serum~     hemoglobin A1c (HbA1c) level in patients with uncontrolled type 2 diabetes mellitus (T2DM)~     and chronic periodontitis.~   "
9360|NCT03444350|"~     The purpose of this study is to evaluate the clinicaland laboratory (as oxidative stress and~     pro-inflammatory mediators) effects of the use of gaseous ozone in periodontal treatment in~     addition to scaling and root planning.~      The study population consisted of 40 patients with CP (chronic periodontitis). It was~     performed with two groups; The Test Group, and the Control Group. SRP plus gaseous ozone [1 W~     (100 mJ, 10 Hz)] was applied to the Test Group. The Control Group, on the other hand, had~     only SRP.The clinical periodontal parameters were performed and saliva samples were taken~     before SRP (baseline) and 1 month after treatment. The periodontal examination involved~     assessing the plaque index, gingival index , probing depth, and clinical attachment level.~     The total antioxidant status, total oxidant status, nitric oxide, 8-hidroxi-deoksiguanosine,~     myeloperoxidase, glutathione, malondialdehyde and transforming growth factor-beta levels were~     determined in the saliva samples.~   "
9361|NCT03444337|"~     Patients undergoing FIRM guided ablation of atrial fibrillation will undergo high resolution~     MRI imaging to determine correlation of underlying anatomic fibrotic regions with FIRM~     targeted sites for ablation.~   "
9362|NCT03444324|"~     The purpose of this study is to investigate efficacy and safety of fibrinogen concentrate~     BT524, when administered to patients with major blood loss during elective spine surgery.The~     study aims to demonstrate that BT524 is at least not worse than the comparator fresh frozen~     plasma in reducing intra-operative blood loss.~   "
9363|NCT03444311|"~     Ulcerative colitis (UC) is an entity of complex etiology where environmental, genetic and~     intestinal microflora-related factors trigger and perpetuate a chronic inflammation of the~     gastrointestinal tract. It is suspected that an alteration in primary intestinal microbial~     colonization (dysbiosis) could trigger, or at least contribute to, said oversized immune~     response. The hypothesis is that the administration of a series of fibers, could improve the~     bacterial diversity and repair the dysbiosis that has been seen in patients affected by~     ulcerative colitis, improving the clinical evolution of it. The primary objective of the~     present study is to know the impact on the microbiota of patients with UC in remission~     derived from the administration of dietary fibers. The RETOS study is a pilot project in~     which a population of patients with UC is tested for the effect on the composition of the~     microbiota that would have the administration of various combinations of fibers, in addition~     to the tolerability and acceptance by the patient. The clinical applicability derived from~     this intervention would be to improve the diversity of intestinal flora of patients with~     ulcerative colitis.~   "
9364|NCT03444298|"~     Purpose: To determine the efficacy of 1400 mg gamma tocopherol-enriched supplement for~     mitigating inhaled wood smoke particle-induced airway inflammation in healthy adults~   "
9365|NCT03444285|"~     The objectives of this study is to determine the immediate and 10 minutes follow-up effects~     of a warm-up based on a continous run on a treadmill or the application of a hot-pack in~     athletes with previous hamstring injury. The investigators have as an hypothesis that the~     subjects, after one of this interventions show statistically significant improvements in the~     measurements of pain, flexibility, proprioception and postural control~   "
9366|NCT03444272|"~     Sofosbuvir plus Daclatasvir in Treatment of Chronic Hepatitis C Genotype 4 Infection in a~     cohort of Egyptian patients: an experiment the size of Egyptian village~   "
9367|NCT03444259|"~     The objective of CAREBANK study is to establish definitive relationships with human cardiac~     samples and clinical phenotypes in patients undergoing cardiac procedures. Specifically, the~     investigators aim at comparing atrial phenotypes from atrial fibrillation patients and~     controls. The work consists of three broad categories: A) role of atrial cardiomyopathy in~     atrial fibrillation; B) genetic defects predisposing to atrial fibrillation; and C) the role~     of inflammation in atrial fibrillation.~   "
9368|NCT03444246|"~     To clarify the influence of iodine intake in salt on the incidence and treatment of~     hyperthyroidism patients, so as to provide theoretical basis for accurate formulation of~     iodine intake in salt, and provide strategies for effective prevention and control of~     hyperthyroidism.~   "
9369|NCT03444233|"~     The purpose of this study is to investigate how a high-fructose diet, either by high fructose~     intake from complex, natural foods or by fortifying the diet with corn syrup, affects the~     metabolism. Furthermore, it will be investigate if there are differences between obese and~     normal weight participants.~   "
9389|NCT03443973|"~     This randomized, double-blind, placebo-controlled, parallel group study will evaluate the~     efficacy and safety of gantenerumab versus placebo in participants with early (prodromal to~     mild) AD. All participants must show evidence of beta-amyloid pathology. Eligible~     participants will be randomized 1:1 to receive either subcutaneous (SC) injection of~     gantenerumab or placebo. The primary efficacy assessment will be performed at the end of the~     double blind period at week 104. Participants will then be offered to enter into an~     open-label extension (OLE). Participants not willing to go to the OLE will participate in a~     long term follow-up period for up to 50 weeks after the last gantenerumab dose.~   "
9370|NCT03444220|"~     Systemic Sclerosis (SSc) is a progressive multi-organ disorder with high disease burden. Life~     expectancy in SSc is reduced by 25-40 years, mainly due to cardiopulmonary and~     gastro-intestinal (GI) disease involvement; and a very poor response to available treatment.~     Aiming to improve treatment for SSc, the ReSScue project will determine the therapeutic~     potential of standardized, cultivated gut microbiome transplantation (GMT), and assess the~     mechanisms by which this novel intervention strategy works. This approach is rationalized by~     studies indicating that skewed gut microbiomes could act as major, environmental risk factors~     in SSc; and thereby be rational targets for therapeutic manipulation. ReSScue is set up as a~     4 months randomized double blind trial involving the University Hospital in Oslo. Trial~     participants will be recruited from the population-based, nationwide SSc cohort. Intervention~     will be by GMT or placebo. Primary end point is reduction in SSc disease activity, while~     secondary outcomes include safety, explorative clinical parameters, changes in oral, skin and~     gut microbiomes, and in immune cell phenotypes.~   "
9371|NCT03444207|"~     The aim of this study was to compare the effects of three months' endurance training and~     three months' endurance-strength training on inflammatory markers in women with abdominal~     obesity.~   "
9372|NCT03444194|"~     More than 4200 new cases of colorectal cancer (CRC) are diagnosed each year in Denmark, and~     30.000 patients live with the diagnosis. Up to 40% of CRC patients will have synchronous~     liver metastases (LM) at the time of the diagnosis or will develop metachronous LM during the~     course of their disease. CRC-LM are treated with a combination of chemotherapy and liver~     surgery, but less than 25% of the referred patients with CRC-LM may be treated with curative~     intend. If looking at population-based data this figure drops to less than 5%.~      During pre-operative chemotherapy the treatment response is monitored by CT and MR scans, and~     the patients are then discussed on multidisciplinary team (MDT) conferences. However,~     monitoring is inaccurate since the simple measurement of size of the liver lesions cannot~     provide reliable evidence of the treatment response. The cancer cells may actually have been~     replaced by scar tissue but without any shrinkage.~      The question is how may we improve the evaluation of treatment response? With the goal of~     improving the assessment of the response to chemotherapy, and thereby only treat the patients~     that will benefit from chemotherapy?~   "
9373|NCT03444181|"~     Music has powerful effects on memory in patients with neurodegenerative diseases. However,~     although there is anecdotal evidence for beneficial effects of active music interventions in~     patients with Alzheimer's disease (AD), there is lack of high-quality research investigating~     this issue, and the cognitive, emotional, and social factors that contribute to potentially~     beneficial effects of music making in AD patients are largely unknown. In a randomised~     controlled intervention trial, a cohort of AD patients will undergo twelve months of music~     lessons specifically tailored for AD patients. Structural and functional magnetic resonance~     imaging (MRI) will be used to determine changes in brain age (as compared to two control~     groups), and voxel-based morphometry will be computed to determine contributions of different~     factors of the music intervention (cognitive, emotional, and social) to plastic changes of~     brain morphology, and a potential deceleration of brain atrophy. In addition, quality of life~     of patients. In cooperation with the Bergen municipality, and a strong network of national~     and international partners, the neurocognitive music therapy will be implemented, involving~     training of music therapists, and communication of results to patients, patient groups, and~     therapists.~   "
9374|NCT03444168|"~     The purpose of this study is to learn whether or not certain risk factors and patient~     characteristics are linked with and possibly can predict the development of chronic pain~     after lumbar spine surgery.~   "
9375|NCT03444155|"~     In a cross-over study the investigators evaluate the effects of natural (Panmol-B-Complex)~     versus synthetic vitamin B complexes to identify the bioavailability of distinct vitamins as~     well as long-term effects. The primary hypothesis for this study: Natural Vitamin~     B-complexes are as effective as synthetic Vitamin B-complexes or better. For this reason 30~     subjects (18 to 65y; BMI >19 to <29) were recruited for this study. The study population was~     divided into 2 groups of each 15 subjects in a cross-over trial. Vitamin supplementation~     consisted of Thiamine (2,77mg), Riboflavin (3,53mg), Niacin (40,32mg), Pantothenic acid~     (15,12mg), Pyridoxine (3,53mg), Biotin (0,13mg), Folic acid (0,50mg) and Cobalamin (6,3µg)~     per day in both groups. Blood samples are taken at baseline - 1.5h after vitamin~     supplementation - 4h - 7h - 6 weeks - wash out phase I (2 weeks); start cross-over: baseline~     - 1.5h after vitamin supplementation - 4h - 7h - 6 weeks - washout phase II (6 weeks). In~     case of main target criteria Thiamin, Riboflavin, Pyridoxine, Folic acid and Cobalamin were~     measured in serum as well as total peroxides (µmol/L), peroxidase-activity (U/L), total~     antioxidant status (mmol/L) and polyphenols (mmol/L).~   "
9376|NCT03444142|"~     Mortality due to cardiovascular problems is increased by having Diabetes Mellitus type 2~     (DM2), related to the time of evolution and glucose levels or if alterations in blood~     pressure coexist. With this variability there is greater damage to the target organ and in~     patients with DM2 the process is more severe and frequent due to alterations in the~     coagulation mechanisms that accelerate in the presence of hypertension, figures ≥135 / 85~     mmHg are considered risk factors to develop coronary, cerebral or renal events. As a~     quantitative range, blood pressure is currently monitored ambulatory by (MAP) which is the~     most used and reliable non-invasive instrument for its evaluation. The American Association~     of Clinical Endocrinologists (AACE) proposes an algorithm that contemplates initiating~     management to patients with a diagnosis of diabetes with drugs such as metformin,~     thiazolidinediones and glucagon-like peptide analogues type 1 (GLP1).~      Exenatide LAR and Dulaglutide are GLP-1 analogue drugs with potential to decrease the~     progressive losses of pancreatic β cell function and mass and cardiovascular risk (CV)~     factors with maintained use, in addition to hypoglycemic, hypotensive effects, weight~     decreases and visceral adiposity, however, it has been reported that although they share the~     same basic mechanism of action, each one has a different molecular structure and~     pharmacokinetic profile that make their pharmacological and clinical effects different, in~     particular as regards the variability of blood pressure and heart rate.~   "
9390|NCT03443960|"~     This will be a single center, comparative pharmacokinetic, open-label, randomized,~     multiple-dose, 1-period, 2-arm, parallel study of TNX-102 SL 5.6 mg (administered as 2 x 2.8~     mg tablets) to AMRIX® (cyclobenzaprine hydrochloride [HCl] extended-release [ER] capsules),~     30 mg.~   "
9377|NCT03444129|"~     Broad, diverse, and innovative efforts are needed to address the growing dual public health~     challenges of obesity and diabetes, especially for those at increased risk like minority~     older adults. The emerging field of health games offers an innovative opportunity to reach~     populations to provide healthy eating and physical activity messages. Little research has~     focused on the use of health games specifically tailored for older adults. This study builds~     upon a health game designed to provide knowledge, facilitate movement, enhance motivation,~     and encourage healthy eating (HE) and physical activity (PA) behaviors in youth. This study~     will adapt, implement, and evaluate the feasibility, acceptability, adherence, and~     preliminary outcomes of the game among overweight/obese African American older adults.~   "
9378|NCT03444116|"~     Excessive anteversion is commonly observed in the cerebral palsy (CP) population. This can be~     treated by an orthopedic surgery, called femoral derotation osteotomy (FDO), to de-rotate the~     femur. It is a vital aspect of patient care to understand if the effects of an FDO are~     maintained long-term. The results of this study will have direct clinical impact by equipping~     providers with the necessary information to counsel families by providing families the~     information needed to make the most informed decision possible about this aspect of their~     child's healthcare.~   "
9379|NCT03444103|"~     This bi-center study (Medical University of Vienna & Charité Berlin) is an~     investigator-driven pilot trial designed to assess the safety, tolerability,~     pharmacokinetics, pharmacodynamics and efficacy (preliminary assessment) of humanized~     anti-IL-6 monoclonal antibody clazakizumab in kidney transplant recipients with late~     antibody-mediated rejection (ABMR). The study is designed as a phase 2 trial and has two~     subsequent sub-parts, a randomized placebo-controlled trial (part A) of 12 weeks, where~     recipients are allocated to receive either anti-IL-6 antibody clazakizumab (n=10) or placebo~     (n=10), followed by an open-label prospective study, where all 20 study patients will receive~     clazakizumab for a period of 40 weeks. Study protocol biopsies will be performed at the end~     of part A and part B.~   "
9380|NCT03444090|"~     Small colon polyps which are found during colonoscopy insertion are sometimes difficult to~     find during withdrawal and thus missed. The investigators aim to evaluate the differences of~     colon polyp/adenoma detection rates of patients undergoing additional inspection and~     polypectomy during insertion as compared to the patients undergoing traditional practice of~     careful inspection and polypectomy performed entirely during withdrawal of colonoscopy.~   "
9381|NCT03444077|"~     Early identification of trauma patients in need for Damage Control Resuscitation (DCR) has~     potential to be beneficial for general emergency units that are not expected to be ready for~     this rare situation 24 hours per day, 7 days per week. It could also be useful for high~     performing trauma centers to identify such patients earlier and be able to provide earlier~     adequate treatment.~      By contrast, initiation of DCR in patients who do not require this aggressive therapy may~     negatively affect their survival. An early identification of patients who do not require DCR~     would probably be beneficial (impact on cost-effectiveness and on patients' survival).~      The evidence of the Trauma Induced Coagulopathy Clinical Score (TICCS) accuracy has been~     evaluated in several studies but the potential effect of its use on patient outcomes needs to~     be evaluated. There has never been any evaluation of the impact of a prehospital~     discrimination of trauma patients with or without the need for DCR.~      The primary objective of this study is to evaluate the impact on mortality of a prehospital~     discrimination between trauma patients with or without a potential need for DCR. Secondary~     objectives include evaluation of the feasibility of such discrimination and its impact on~     cost-effectiveness. We hypothesize that the information will lead to improved quality of care~     with reduced mortality and morbidity.~   "
9382|NCT03444064|"~     Islet transplantation is a relatively new procedure used in people with difficult to control~     Type 1 diabetes. Patients who receive an islet transplant take medication that suppresses~     their immune system and prevent rejection of the islet tissue. In spite of the strengths of~     the current immunosuppression regimen, it has failed to enhance single-donor success rates,~     and the majority of patients require 2 or more islet transplants to achieve insulin~     independence. The need for life-long, high-dose immunosuppression is also associated with~     substantial side effects, and continues to limit application of islet transplantation earlier~     in the course of the disease.~      The investigators have learned that Regulatory T cells (Tregs), a small subset of cluster of~     differentiation 4+ (CD4+) T cells, have emerged as the major contributor to self-tolerance~     through suppression of activation and effector function of other immune cells. Tregs function~     by preventing the initiation of unwanted immune activation and by suppressing ongoing immune~     response to limit bystander tissue destruction. It has been suggested that infusion of Tregs~     before extensive graft damage may improve long-term graft outcomes.~      This study is an open label, controlled, dose finding pilot study. Up to 18 participants will~     be recruited including 12 participants receiving the investigational treatment and 6~     participants being assigned to control group. All participants will undergo the routine~     Standard of Care islet transplant procedure, and will be maintained on lower dose tacrolimus~     and sirolimus immunosuppression.~      The primary goal is to assess the safety and feasibility of intravenous infusion of ex~     vivo-selected and ex vivo-expanded autologous PolyTregs in islet transplant patients. The~     other goal is to assess the effect of Tregs on beta cell function in islet transplant~     patients.~      The control group (6) will receive the current Edmonton islet transplant induction therapy~     (Alemtuzumab with Etanercept and Anakinra). The intervention group (up to 12) will receive~     islet transplant with same induction therapy as control group and PolyTregs (400-1600~     million) six weeks post- transplant and will be followed for 1 year to assess safety and~     preliminary efficacy of Treg therapy. The Treg product will be administered via a peripheral~     intravenous (IV) line primed with saline per established standard operating procedures in~     approximately 20 to 30 minutes. The intravenous line will be maintained after the infusion~     and the participant will be asked to remain in the hospital for 24 hours. All participants~     will be maintained on low dose tacrolimus and sirolimus immunosuppression.~      The investigators will also use retrospective data from the islet transplant cohort receiving~     Tac/mycophenolate mofetil(MMF) with alemtuzumab (>100 patients).~      All study participants will be followed up for 58 weeks. Tests and assessments will be~     performed at each key study visit and will be allowed for +/- 2 weeks to accommodate~     scheduling.~      The following measurements will be recorded at each key study visit :~      Blood work, including the following:~      Complete blood count (CBC) and differential~      Creatinine and electrolytes~      Fasting glucose and c-peptide~      Any adverse events~      Physical examination~      Body weight (kg)~      Vital signs (BP, HR)~      Glucose records for self-monitoring.~      Hemoglobin A1c~      Insulin use (total daily dose)~      Autoantibodies and autoreactive T cell~      MMTT~      Immune profile~   "
9383|NCT03444051|"~     This observational study compared quality of histological sampling of pancreatic EUS-FNB with~     the 20-gauge Procore® and 22-gauge Acquire® needles. In total, 68 patients were recruited.~     Histological diagnosis was achieved and a histological core biopsy was obtained in 82% of~     patients (28/34) in the 20-gauge Procore® group and 97% of patients (33/34) in the 22-gauge~     Acquire® group (P=0.1). Core biopsy specimens obtained were significantly longer with the~     22-gauge Acquire® needle with a mean cumulative length of tissue core biopsies per needle~     pass of 4,33±3,46mm vs. 7,9±4,35mm for the 20-gauge Procore® (P<0,01). Reproducibility of~     this simple histological criterion was validated in intra and inter-observer.~   "
9384|NCT03444038|"~     This is a Phase 2b, multicenter, open-label study to evaluate the safety and tolerability of~     optimized doses of NBI-98854 administered once daily for 24 weeks in pediatric subjects with~     Tourette Syndrome.~   "
9385|NCT03444025|"~     This is a phase II randomized trial that will evaluate the effect of adding LHRH analogue,~     goserelin, to the standard neoadjuvant chemotherapy to patients with triple negative breast~     cancer. Targeting LHRH might decrease resistance to chemotherapeutic agents in the~     neoadjuvant setting and increases clinical and pathological response rates. Additionally,~     exploring potential surrogate markers (as AR and LHRH receptors) for molecular distinct~     subtypes of TNBC.~   "
9386|NCT03444012|"~     noninterventional study investigating persistence and adherence on ticagrelor in ACS patients~     in Serbia~   "
9387|NCT03443999|"~     The primary objective of this registry is to evaluate the safety and efficacy of the~     Supraflex sirolimus-eluting coronary stent system in a 'real-world' patient population~     requiring stent implantation.~   "
9388|NCT03443986|"~     Introduction: Diabetes Mellitus (DM) is an important health condition of the population and~     its prevalence continues to grow due to population aging, economic development and~     urbanization. The exercise is an important factor of prevention and control, thereby~     decreasing the risk of metabolic diseases, cardiovascular diseases and improving the~     functionality of the patient with diabetes.~      Objective: Evaluate the response of resistance training associated with whole-body vibration~     on peripheral circulation and functional performance of elderly with type 2 diabetes.~      Methods: This is a clinical trial study, controlled, randomized and blinded, which will~     follow the guidelines established by the Consolidated Standards of Reporting Trials~     (CONSORT). Patients will be recruited in the light of the eligibility criteria and randomly~     divided into 3 groups: resistance training associated with whole body vibration (G1),~     resistance training associated with vibration sham (G2) and control group-guidelines about~     foot care (GC), establishing 36 treatment sessions, three times a week for the G1 and G2.~   "
9392|NCT03443934|"~     Liver cirrhosis is a chronic disease characterized by a progressive accumulation of fibrosis,~     loss of liver function and portal hypertension leading to several hemodynamic changes.The~     exact pathophysiological mechanisms causing the hyperdynamic alterations in cirrhosis are not~     fully elucidated.~      Aim:~      The aim of the study is to assess hemodynamic alterations in liver cirrhosis by non-invasive~     MRI and echocardiography compared to portal hypertension measured with liver vein~     catheterization (HVPG, hepatic vein pressure gradient). Furthermore, the aim is to explore~     hemodynamic differences between cirrhotic patients and healthy subjects.~      Study design and cohort:~      The study has a cross-sectional design and a cohort with 54 patients with liver cirrhosis -~     with and without complications and 18 healthy volunteers. The patients are recruited at the~     Gastrounit Hvidovre University Hospital.~      The day before the first visit patients are hospitalized and fasting overnight. At first~     visit liver vein catheterization (LVC) and echocardiography are performed. Second visit must~     be performed within 4 weeks after first visit. At the second visit patients are fasting~     minimum 6 hours before having MR-flow scanning, cardiac-MR and MR-Elastography (MR-E).~      The healthy volunteers are only offered MR-flow scanning, cardiac MR and MR-E as well as~     urine- and blood tests~   "
9393|NCT03443921|"~     Pancreatic cancer is the most lethal malignancy of human being. Surgery is the only potential~     cure of pancreatic cancer. The invasion of major abdominal arteries is one of the most~     important factor restricting surgical intervention. For artery-involved pancreatic cancer~     (ai-PC) patients, pre-operative adjuvant therapies, especially the neoadjuvant chemotherapy,~     has brought exciting postoperative survival. Yet due to the potential screening effect of~     this treatment strategy, nearly half of ai-PC patients failed to benefit from surgery because~     of disease progression, adverse reactions of adjuvant treatment and other reasons. Artery~     divestment for the treatment of ai-PC firstly reported by our center, can significantly~     increase resection rate and produce overall survival benefit in some patients. This study is~     to explore whether up-front surgery with artery divestment combined curative pancreatectomy~     or the chemotherapy-first strategy would be more beneficial for ai-PC patients' survival.~      Subjects will be randomized to treatment group either receiving up-front artery divestment~     combined pancreatectomy (Surgery Group) or adjuvant chemotherapies (Chemo Group). In Surgery~     Group, an artery divestment combined pancreatectomy will be performed if no pre-operative~     contra-indication or intra-operative metastasis were revealed. Post-operative adjuvant~     chemotherapies were prescribed according to performance status. In Chemo Group, adjuvant~     chemotherapy of gemcitabine or gemcitabine + cisplatin will be utilized according to~     performance status. After 2 circles of adjuvant chemotherapies, patients will be reevaluated~     and curative operation would be attempted if without disease progression.~      Overall mortality at one year after randomization will be the primary endpoint. Other~     parameters as overall survival after 2 and 3 years, median survival, disease-free survival,~     margin status of subjects receiving curative surgery, etc. will also be observed.~   "
9394|NCT03443908|"~     Sleep-disordered breathing at night is a common medical problem. It leads to daytime fatigue,~     impairment in concentration and daily activities, and a higher risk of cardiovascular disease~     and life-threatening events. A particularly common form is obstructive sleep apnea (OSA), and~     it is usually treatable with a high rate of patient satisfaction and improved quality of life~     using a continuous positive airway pressure (CPAP) device.~      Treatment of this condition improves nighttime low-oxygen levels by ensuring patency of the~     upper airways. Research shows that in cancer, sleep disordered breathing is frequent. Low~     oxygen levels overnight may cause tumors to grow: tumors deprived of oxygen grow more blood~     vessels to try to get more oxygen, and growing more blood vessels makes the tumor grow. This~     study aims to examine how treating sleep-disordered breathing may lessen blood-flow to lung~     tumors, and thus serve to ultimately block tumor growth.~      Participants of this study will undergo sleep study and receive CPAP therapy as a part of~     routine care.~   "
9395|NCT03443895|"~     The study is designated to evaluate the safety, tolerability, pharmacokinetics (PK) and~     pharmacodynamics (PD) of escalating multiple oral doses of AEF0117 in healthy adult male and~     female subjects.~   "
9396|NCT03443882|"~     Bioavailability of dietary supplement formulations in healthy volunteers after a single oral~     dose.~   "
9397|NCT03443869|"~     The primary objective of this study is to evaluate the efficacy of letermovir (LET) versus~     valganciclovir (VGCV) in preventing CMV disease in adult kidney transplant recipients. The~     primary hypotheses are that LET is non-inferior to VGCV; and if non-inferiority is~     demonstrated, that LET is superior to VGCV, in preventing CMV disease through 52 weeks~     post-transplant.~   "
9398|NCT03443856|"~     The primary objective of the trial is to investigate if nivolumab plus ipilimumab given as~     adjuvant treatment improve disease free survival (DFS) in patients with stage Ib-IVa gastric~     and esophagogastric junction adenocarcinoma and high risk of recurrence (defined by ypN1-3~     and/or R1 status) following neoadjuvant chemotherapy and resection.~      Other study objectives:~        -  To investigate the safety and effect of adjuvant immunotherapy on long term oncologic~          outcomes and quality of life of patients in the study~        -  To correlate nutritional status assessment on outcomes and quality of life of patients~   "
9399|NCT03443843|"~     The purpose of the study is to evaluate changes in nasal airflow caused by loratadine 5~     mg/pseudoephedrine sulfate 120 mg (Claritin D) tablet and fluticasone propionate 50 mcg per~     spray nasal spray (Flonase) in subjects suffering from nasal congestion and other allergy~     symptoms.~   "
9400|NCT03443830|"~     Zika virus (ZIKV) infection is a new emerging arbovirus disease, caused by the same vector~     that transmits Dengue virus, Aedes aegypti. ZIKV is a growing public health problem, rapidly~     spreading throughout the continents since the first epidemic was reported in the French~     Polynesian islands.~      Currently, there are several ZIKV vaccine candidates in clinical trials. However, no ZIKV~     therapy (biologic or small molecule) has advanced to clinical trials. Tyzivumab will be the~     first therapeutic in the world, specifically targeting ZIKV, to enter clinical trials.~      This is a Phase 1, first in human, time-lagged, parallel-group, single dose ascending (6 dose~     cohorts), Tyzivumab, ZIKV monoclonal antibody (mAb), study to be conducted in 24 flaviviral~     naïve healthy adult volunteers.~      Tyzivumab will be administered once through single IV infusion over 30 minutes. Total~     duration of study participation is estimated at approximately 98 days from the date of~     screening. Post-trial monitoring through weekly telephone calls will continue from Day 85~     post-dose onwards for another three (3) more months.~      The main objective of this study is to evaluate safety of Tyzivumab in healthy adult~     volunteers through assessment of subject vital signs, clinical laboratory results, ECG,~     presence/absence of AE/SAE, PK and ADA.~   "
9596|NCT03441217|"~     To evaluate the duration of labour (active phase of labour) in nulliparous women with~     gestations between 37 and 41 6/7 weeks when 20 mg of Hyoscine butylbromide was applied~     intravenously and compared with similar patients that received a placebo.~   "
11950|NCT03410394|"~     This registry aims to collect informations about patients with endocrine tumors (Thyroid,~     Parathyroid, Adrenal, Endocrine Pancreas, Endocrine Digestive Tube) who undergo endocrine~     surgical procedures. This registry is part of the Eurocrine Project.~   "
9401|NCT03443817|"~     Introduction In order to guarantee chronic patients & elderly a high quality service from~     health care organizations in the coming decades, new technologies have been implemented to~     treat patients from a distance. There is still a need for more studies on the efficacy and~     cost-effectiveness of tele-rehabilitation (TR) and its long-term effects needs also to be~     determined. To guarantee individuals with chronic obstructive pulmonary diseases (COPD) a~     high quality service from health care organizations in the coming decades and economically~     save the national health systems for an expensive bill for the treatment of COPD, new actions~     plans has to be taken into use. Hereby, more patients can be treated with less human~     resources while still sustaining or even improving today's services. The importance of such~     welfare action plans has to maintain a high quality of service that individuals with COPD are~     willing to accept. Here, TR seems to be a good welfare action plans. Despite proof of~     improved cost-effectiveness, no studies support the benefits of TR in COPD patient with~     respect to adherence, security, treatment efficacy and improved quality of life.~      Aim To assess and compare the feasibility and effect of a tele-rehabilitation program with a~     new and innovative TR platform (NITRP) compared to standard treatment with respect to~     exercise capacity, quality of life and activities of daily living in patients with COPD.~      Method and material The study is a prospective randomized controlled trial comparing the~     effects of a follow-up tele-rehabilitation program and conventional follow-up rehabilitation~     in patients with severe COPD. 54 patients fulfilling the inclusion criteria will be~     randomized in two groups to either an 8 week follow-up tele-rehabilitation program or to~     standard follow up after rehabilitation. Participants will be tested at baseline, after 8~     weeks and 6 months after cessation of the training programs. In the intervention group, a~     real- and a virtual physiotherapist agent will facilitate the rehabilitation.~      Ethical considerations This study will not pose any risk to the patient as compared to~     current practice. Participation is voluntary and the patient may at any time withdraw from~     the study without consequences for future care or treatment. The questionnaires and the test~     methods used are clinically recognized instruments. Signed informed consent will be obtained~     from the all participants after verbal and written information and before the study starts.~     The study will not be initiated before approval from the Ethics Committee and the Data~     Protection Agency has been obtained. The study will follow the general research ethical rules~     as expressed in the Helsinki Declaration II.~   "
9402|NCT03443804|"~     Evaluate the Efficacy and Safety of DW1401 versus Stillen tab. in Patients with Acute or~     Chronic Gastritis~   "
9403|NCT03443791|"~     The objectives of the protocol are to determine if a structured cognitive-behavioral~     interventional counseling of pregnant women can limit acquisition of human cytomegalovirus~     (HCMV) during pregnancy that we believe, will in turn decrease the incidence of congenital~     HCMV infections in this highly seroimmune population. Previously, investigators have~     demonstrated the success of a similar approach in pregnant women without previous evidence of~     HCMV infection (non-immune women) but to date, there is no evidence that such an approach~     will alter the incidence of congenital HCMV infections in seroimmune women. This protocol~     will take advantage of recently derived data in this maternal population that has identified~     sources HCMV exposure in women in this population and thus provided new insight into targeted~     counseling interventions that could limit maternal acquisition of HCMV. The primary endpoints~     of this study will be a 50% reduction in the overall incidence of congenital HCMV infections~     in this maternal population with secondary endpoints being efficient uptake of behavioral~     recommendations and modifications of simple hygiene behaviors that have previously been shown~     to decrease exposure and acquisition of HCMV.~   "
9404|NCT03443778|"~     Investigators compared in this study peritonsillar infiltration of bupivacaine %0.5 (n=40~     participants) versus bupivacaine % 0.5 and dexamethasone (number 40participants ) before~     surgery for reduce posttonsillectomy pain.And control group (n= 40participants) participants~     received peritonsillar Nacl 0,9% .~   "
9405|NCT03443765|"~     Pityriasis alba (PA) is a common, benign skin disorder occurring predominantly in children~     and adolescents. It is characterized by ill-defined hypopigmented macules and patches, round~     or oval in shape. They are most commonly located on the face (especially the cheeks), arms,~     and upper trunk; and they are more noticeable in people with darker skin types. Sun exposure~     accentuates the lesions. Patients and their parents are often anxious about the cosmetic~     appearance of the lesions. PA is not seasonal, although peeling may be worse in the winter~     (as a result of dry air in homes) and lesions may be more obvious in the spring and summer~     (as a result of sun exposure and darkening of the surrounding skin).No specific cause of PA~     has been identified. It is not contagious, and no infectious etiology has been reported. It~     is most common in individuals with a history of atopy, although it may occur in nonatopic~     individuals.~      In the present study, we will investigate the role of serum vitamin D levels and serum total~     IgE levels with development and course of PA. Plasma levels of 25(OH) vitamin D and Total~     serum immunoglobulin E will be determined by using ELISA technique.~   "
9406|NCT03443752|"~     The following study will be a comparison of balance and quality of life in Tai Chi training~     programs and Shotokan-Karate training programs in individuals with Parkinson's Disease. The~     following study will be a 12-week program which will assess whether or not Shotokan-Karate~     betters balance and quality of life even more than Tai Chi. Both Tai Chi and Karate will be~     taught by a professional instruction at the Sun Life Financial Movement Disorders and~     Rehabilitation Centre located in Waterloo, Ontario.~   "
9407|NCT03443739|"~     The aim of the study is to find out the effects a specific religious fast (i.e. Bahá'í fast)~     has on certain metabolic parameters, hydration, psyche and circadian clock~   "
9408|NCT03443726|"~     This study is a Randomized Controlled Trial (RCT) which objective is to compare the~     effectiveness, efficacy and complication associated to an infiltrative anesthetic technique~     for the removal of lower third molars comparing it to the standard inferior alveolar nerve~     block using 4% articaine 1:100.000 epinephrine.~   "
9409|NCT03443713|"~     The goal of this study is to assess the impact of physician-driven insulin setting changes in~     type 1 patients using multiple daily injection insulin therapy with exercise. This is a short~     outpatient study with multiple outpatient and home exercise sessions with an assigned type of~     exercise.~   "
9418|NCT03443596|"~     Management of acutely elevated blood pressure during the early phase of ischemic stroke~     remains controversial. In patients treated with IV-tPA, the risk of ICH is closely related to~     the BP levels. However, intensive reduction of BP carries a theoretical risk of clinical~     deterioration by inducing cerebral hypoperfusion. Assessment of cerebral perfusion before and~     after BP reduction is one of the most scientific method to evaluate the safety (and potential~     benefits) of BP management in the acute phase of stroke. This project will impact practices~     and delivery of BP management during the acute phase of ischemic stroke. The findings would~     aid in designing phase 3 clinical trials will track clinical indicators, including the impact~     on functional outcomes as well as quality-of-life and cost-effectiveness.~   "
9419|NCT03443583|"~     Immediate Dentin Sealing as an adjunct to adhesive cementation of all ceramic restorations is~     proposed and executed in several studies, but there is very limited evidence to support its~     effectiveness. It is presumed that IDS both reduces postoperative sensitivity and increases~     the bond strength to dentin as compared to DDS.~   "
9410|NCT03443700|"~     The recent introduction of robotics for locomotor training in paraplegic patients, and in~     particular the use of anthropomorphic exoskeletons, has opened new frontiers in~     rehabilitation. Existing literature, though encouraging, is still scarce and studies~     demonstrating efficacy are highly heterogeneous and have a small sample size. Evidence is~     also needed about cortical plasticity after SCI, in conjunction with the use of innovative~     rehabilitation devices, through indicators like neurophysiological and neuroradiological~     markers, as the knowledge of such mechanisms is crucial to improve clinical outcomes.~     Cortical circuits controlling prosthetic devices are different from those controlling normal~     parts of the body and remodeling mechanisms following prosthetic use have been documented,~     but in conditions other than SCI.~      The aims of this randomized controlled trial, with a 2-arm parallel-group design, are:~        1. to evaluate and quantify the efficacy of locomotor rehabilitation with a robotic~          anthropomorphic exoskeleton (EKSO-GT) in terms of clinical and functional outcomes, and~          the persistence of such efficacy;~        2. to investigate the presence and persistence of brain neuronal plasticity and cortical~          remodeling mechanisms underlying the robotic rehabilitation approach.~      Forty patients will be recruited and randomly assigned to 2 treatment arms. Both groups will~     follow a program of standard locomotor rehabilitation for 8 weeks. One group will also~     undergo an overground locomotor training with the EKSO-GT during the first 4 weeks.~   "
9411|NCT03443687|"~     This randomized controlled study evaluates the effect of home biofeedback compared to pelvic~     floor physical therapy for the treatment of stress urinary incontinence. Half of the~     participants will use a home biofeedback device for 3 months and the other half will attend~     pelvic floor physical therapy appointments for 3 months.~   "
9412|NCT03443674|"~     The purpose of this study is to evaluate the safety, tolerability, preliminary efficacy, and~     PK/PD of SCB-313 (recombinant human TRAIL-Trimer fusion protein) administered once daily over~     3 days via IP bolus injection for the treatment of cancer patients with recurrent refractory~     malignant ascites.~   "
9413|NCT03443661|"~     This study aims to investigate the feasibility, safety and efficacy of triplet regimen of~     neoadjuvant chemotherapy in patients with locally advanced rectal cancer~   "
9414|NCT03443648|"~     Assessment of accuracy of correction of genu varum more than 20 degrees using external~     fixator assisted plating. Intraoperatively, the operative time needed for completion of~     accurate correction, torniquet use, blood loss will be assessed. Postoperative complications~     either early ones like infection, thromboembolic complications, peroneal nerve palsy or late~     post operative complications like implant failure, delayed union, non union and bone healing~     time will be assessed..~   "
9415|NCT03443635|"~     Cooking for Health Optimization with Patients (CHOP) is the first known multi-site~     prospective cohort study with a nested Bayesian adaptive randomized trial in the preventive~     cardiology field of culinary medicine. It is also the first known longitudinal study to~     assess the impact of hands-on cooking and nutrition education on patient outcomes, with those~     classes taught by medical students and other future and current medical professionals who~     have first been trained in those classes on how to integrate diet and lifestyle counseling of~     patients with their respective scopes of clinical practice. CHOP is the primary research~     study of the world's first known medical school based teaching kitchen, The Goldring Center~     for Culinary Medicine at Tulane University School of Medicine. Medical trainees and~     professionals are followed in this study long-term to understand how the classes impact their~     competencies in patient counseling, attitudes about the counseling, and their own diets.~     Patients who consent to being randomized to these classes compared to standard of care are~     studied within the nested Bayesian adaptive randomized trial to understand how the classes~     impact their health outcomes, clinical and food costs, and the costs of health systems caring~     for these patient populations. CHOP is designed as a pragmatic population health trial to~     hopefully improve healthcare effectiveness, equity, and cost by establishing an~     evidence-based, scalable, sustainable model of healthcare intervention targeting the social~     determinants of health, while complementing the pharmacological and/or surgical management of~     patients.~   "
9416|NCT03443622|"~     This phase I study will be conducted in an open-label, conventional 3+3 dose escalation~     design manner (for the first 28 days of dosing) followed by an extension period for subjects~     responsive to the study drug to continue dosing up to 52 weeks. This study is intended to~     assess the safety and efficacy of the investigational product (IP), SC-43 Oral Solution, in~     subjects with refractory solid tumors. Subjects who have diseases progressing unresponsive to~     the previous treatments or who have no standard treatments for their current diseases will be~     enrolled in this study once the eligibility is confirmed.~      During the first 28 days, the study will be done in the conventional 3+3 design to determine~     the maximum tolerated dose (MTD) of SC-43 Oral Solution. The dose will be increased in a~     step-wise fashion from the initial dose of 100 mg/day to the dose of 200, 400, 600, 900, and~     1200 mg/day. The pharmacokinetics (PK) of SC-43 will also be measured in this period.~      The dose of SC-43 Oral Solution will be escalated to the subsequent cohorts when there is no~     dose-limiting toxicity (DLT) in 3 subjects or only one DLT in 6 subjects of the previous~     cohort, and it is recommended by Data and Safety Monitoring Board (DSMB). The safety results~     will be reviewed by DSMB after the last subject in the each cohort has finished the Visit 6~     (Day 29), and DSMB will determine if it is safe to proceed to the next dose cohort.~      Subjects who have finished the 28-day dose escalation period and with complete response (CR),~     partial response (PR), or stable disease (SD) will be eligible to enter the extension period~     and continue SC-43 Oral Solution therapy up to 52 weeks or until occurrence of unacceptable~     toxicity, withdrawn consent, disease progression, not receiving medical benefit as considered~     by investigators, loss of follow-up, or death, whichever comes first. For ethical and safety~     concerns, the dosage used in this extension period can be adjusted and different from the~     original dosage assignment. The actual dose of SC-43 Oral Solution, which must be confirmed~     safe, administered during this extension period will be at the investigator's discretion.~   "
9417|NCT03443609|"~     68Ga-HBED-CC-PSMA is a radiopharmaceutical allowing a new imaging modality for the detection~     of prostate cancer recurrences, used in recent years in clinical studies by some teams mainly~     in Europe (1-6 ).~      The aim of this study is to study the diagnostic performance of 68Ga-HBED-PSMA PET / CT in~     occult recurrent carcinoma (PCa) by prospectively comparing it to the standard techniques~     used in this indication: optimized bone scintigraphy with double TEMP / CT systematic and~     abdominopelvic MRI. The therapeutic impact and tolerance of this examination will also be~     evaluated.~      The expected results are a demonstration of the superiority of 68Ga-HBED-PSMA PET compared to~     the standard assessment, with a potential impact on the therapeutic management of patients~   "
9420|NCT03443570|"~     The project was undertaking by Qilu Hospital of Shandong University and other 2 well-known~     hospitals in China. In order to report the efficacy and safety of rituximab combining with~     bortezomib for the treatment of adults with immune thrombocytopenia (ITP), compared to~     rituximab alone .~   "
9421|NCT03443557|"~     A retrospective study based on Thai data from Nutrition Day study (nD). Comparing clinical~     outcome between malnourished patients who were prescribed oral nutrition supplement along~     with hospital diet and those without oral nutrition supplement.~   "
9422|NCT03443544|"~     Background:~      Fournier's gangrene it's a necrotizing infection of the genital area, with high morbidity and~     mortality. The site of infection its the origin of the necrotizing fasciitis. There are 4~     well known origins of Fournier's gangrene: Testicular, Intestinal, Urinary and cutaneous, and~     its prognostic value has not been established yet, that's because the lack of case series~     with adequate number of patients. This is a retrospective study in which we evaluate the~     prognostic factors of every patient and its mortality compared with its origin area and~     multiple scores with their survival rates and hospital stay.~   "
9423|NCT03443531|"~     The aim of this study is to evaluate the effectiveness of Traditional Chinese Medicine (TCM)~     on patients with clinically stable bronchiectasis by a multi-center, randomized,~     double-blind, controlled trial: one, TCM treatments based on syndrome differentiation; the~     other, a placebo of TCM treatment.~   "
9424|NCT03443518|"~     Endovascular aneurysm repair (EVAR) was introduced in 1990 for the first time as a minimally~     invasive procedure instead of the conventional open surgical repair, with the aim to decrease~     morbidity and mortality . Nowadays EVAR has become an acceptable management for patients with~     infra-renal aortic aneurysms (AAA) . A lot of anesthetic techniques have been used~     successfully for EVAR. EVAR requires sedative analgesic medications to achieve an acceptable~     level of comfort to the patient and cardiorespiratory stability.~      This is prospective randomized single blinded study of patients presenting with aorto-iliac~     aneurysm who will undergo EVAR. Patient's demographic data will be assessed, as well as~     clinical presentation, intraoperative complications.~      30 patients undergoing elective EVAR will be included and will be divided equally into 2~     groups.~      First group is the psoas compartment block (PCB) (15 patients): 30 ml of bupivacaine 0.25%~     will be infused over 3 minutes at the anatomical landmark.~      Second group is the LA and remifentanil group (LR) (15 patients): lidocaine 5 ml of 2% will~     be injected subcutaneous as local infiltration then remifentanil infusion with rate 0.03-0.1~     μg kg−1 min−1. to achieve visual analog scale (VAS) 3 or less.~      Vital date will be recorded as baseline then every 5 minutes till the end of the procedure.~     VAS will be recorded as baseline then every 5 minutes till the end of the procedure. Also~     stress response which will be measured subjectively as vital data and VAS and objectively as~     cortisol level in the blood which will be measured as base line and immediate after the end~     of the procedure.~   "
9425|NCT03443505|"~     COPD is a common, serious disease and is a major burden on patients and the National Health~     Service. Patients with COPD can develop worsening of their symptoms, known as an~     exacerbation, which can be severe enough to warrant hospital admission. There are currently~     no objective measurements available to patients and clinicians to predict exacerbation and~     monitor recovery. Detection of exacerbation by both patients and physicians is known to~     correlate poorly with onset of respiratory deterioration.~      Measurement of neural respiratory drive (NRD), or drive to breathe, using respiratory muscle~     electromyography (EMG) correlates with changes in patients' symptoms and physician defined~     deterioration during hospital admissions.~      This pilot study aims to identify whether daily measurement of NRD at home following~     admission to hospital with exacerbation of COPD can detect an exacerbation within 30 days of~     discharge (20% of patients are readmitted within this period). This technique could enable~     early detection of deterioration at home, facilitating earlier treatment compared to current~     practice, potentially avoiding hospital readmission.~      30 patients admitted to St Thomas' Hospital because of an exacerbation of COPD aged 40-80,~     with a body mass index <35kg/m2, who can follow English instructions and give informed~     consent, who are discharged home will be recruited. If patients consent to participate, they~     will have assessments as inpatients and for 30 days at home following discharge, or until~     hospital readmission, whichever is sooner. Assessments include vital observations (heart~     rate, blood pressure, respiratory rate and oxygen saturations), NRD, and a symptom~     questionnaire. At the baseline assessment, age, height weight, a brief medical history,~     results of tests already taken by the clinical team (blood tests and chest x-ray) and lung~     function tests will be recorded. This study will take 12 months. Philips and its Affiliates~     are providing the NRD measuring equipment.~   "
9426|NCT03443492|"~     A Phase II Randomized Study.Primary objective:to investigate the 6-month progression-free~     survival (PFS) rate i patients receiving SLOG or mFLFIRINOX as a first-line treatment for~     locally advanced and metastatic pancreatic cancer.~   "
9427|NCT03443479|"~     A retrospective cohort study of all patients treated for type II (hypercapnic) respiratory~     failure with either High-Flow Oxygen Therapy or Non-Invasive Ventilation in a general adult~     hospital.~   "
9428|NCT03443466|"~     Forty pregnant women (36 to 41 weeks gestation) will randomly allocate to two groups. Groups~     will be defined based on the method used to identify the epidural space for epidural~     anesthesia: the loss of resistance group (n=20) and the epidural electric stimulation group~     (n=20). Pain during the cesarean section will be assessed using a numerical visual analog~     scale and maternal satisfaction by a post-partum interview. The success rate of epidural~     anesthesia, maternal satisfaction, and neonatal Apgar scores will be compared between groups.~   "
9429|NCT03443453|"~     This is a single-Center, Randomised, 4-Period, Phase 1 Study to Evaluate the~     Pharmacokinetics, Safety and Tolerability, and Effect of Food on Pharmacokinetics following~     Single Doses of MIV-711 Capsule and Tablet Formulations in Healthy Volunteers~   "
9430|NCT03443440|"~     A longitudinal observational study examining preoperative, intraoperative and postoperative~     factors associated with Postoperative Cognitive Dysfunction in patients older than the age of~     50.~   "
9431|NCT03443427|"~     The purpose of this study is to test two schedules of how a vaccine will be given to patients~     with chronic obstructive pulmonary disease (COPD) to prevent acute exacerbations. An acute~     exacerbation is when during an infection, the breathlessness in COPD patients will get even~     worse than it normally already is, sometimes to the point where oxygen therapy is required.~      In previous studies, study participants have received two doses of the vaccine according to a~     0, 2 month vaccination schedule, in addition to standard care. The current study will find~     out if a third dose of the study vaccine against NTHi/Mcat is safe and working well. The~     study will also investigate if the third dose of vaccine works best when given after 6 months~     or after 12 months.~   "
9432|NCT03443414|"~     The study investigates the effect of 4 weeks of twice daily treatment of four different doses~     of RPL554 (a phosphodiesterase [PDE]3/4 inhibitor) or placebo in patients with moderate to~     severe COPD. Patients will be equally allocated to one of the five treatment options.~   "
9433|NCT03443401|"~     To investigate whether changes in trust between physical therapist and patient correlate to~     outcomes after receiving physical therapy care. We will be utilizing established~     questionnaires from the medical literature and one new generated questionnaire.~   "
9434|NCT03443388|"~     This is a two-part study that aims to determine the reliability and safety of the use of the~     Hövding inflatable helmet in seizures, as evidenced by the deployment of the helmet during~     seizures, and qualitative patient reporting.~   "
9435|NCT03443375|"~     The present study aimed at investigating the effects of two different resistance training~     protocols — nonperiodized (NP) and daily undulating periodization (DUP) — on hemodynamic,~     morphofunctional and cognitive parameters of robust older women. Methods: Forty-two older~     women were randomized allocated into one of the three experimental groups: NP, DUP, and~     control group (CG). Evaluations of the hemodynamic, morphofunctional and cognitive parameters~     occurred before, during and after six months. The exercise groups performed the program of~     exercise twice a week over 22 weeks. In NP, the two weekly sessions were based on 3 sets of~     8-10 repetitions at a difficult intensity. However, in DUP, a power exercise session based on~     3 sets of 8-10 repetitions at a moderate intensity was added in the first session of the~     week.~   "
9436|NCT03443362|"~     Chronic urticaria (CU) is a disease that usually affects a large visible amount of surface of~     the skin. It is accompanied by severe itch and feeling of burned skin. Therefore the disease~     has a big impact on the quality of life of patients. Unfortunately, to date CU is not easily~     controlled by its few existing treatment options (i.e. antihistamines, omalizumab,~     cyclosporine).~      This research's main perspective is to improve quality of life for CU patients by first of~     all focusing on a good clinical diagnosis of (different subtypes of) CU in a CU reference~     center, and secondly by gaining more insight on the pathogenesis of the disease to expand~     knowledge on potential new targeted treatments for the patients.~   "
9437|NCT03443349|"~     Vibwife One was developed to support the mobilization of the delivering women during the~     labor process. It consists of a mattress that fits on existing delivery beds. Different~     movements, adjustable in pace and intensity can be chosen to mobilize women in labor.~      Although existing evidence is rare, some literature and historical reports have shown a~     positive impact of active mobilization during labor.~      At time of rising epidural anesthesia rate, Vibwife One could be an interesting way to~     active mobilize those women to support the physiological birth process.~      So far, the device has not yet been applied in delivering women. The investigators carry out~     a first safety study to assess the safety, to evaluate the comfort and the practicability for~     delivering women and medical staff of this new medical device.~   "
9438|NCT03443336|"~     Prospective multi-center surveillance study on the prevalence of azole-resistant Aspergillus~     spp. in clinical isolates of patients with pulmonary colonization or invasive infections in~     Switzerland~   "
9439|NCT03443323|"~     The purpose of this study is to evaluate the Organizational Skills Training Program - School~     based version (OST-S) in a cluster randomized trial. Participating schools will be randomly~     assigned to one of two groups: 1) an OST-S intervention group and 2) a treatment as usual~     control group. Participating students (3rd through 5th grade) will be from 20 schools in~     Pennsylvania and New Jersey and include both urban and suburban schools serving a diverse~     population. OST-S is a small-group, skills training intervention for children, which includes~     parent and teacher consultation to support student use of new skills. The program is~     delivered by school staff who receive training and consultation from intervention experts.~   "
9440|NCT03443310|"~     The study is designed as a prospective comparative study. All patients will receive~     prophylactic anticoagulation according to routine hospital protocol after surgery. A bedside~     ultrasound examination will be performed by a trained anesthesiologist prior to the surgery~     and then daily beginning on postoperative day 2 until patient discharge.~   "
9441|NCT03443297|"~     The introduction of enteral feeds for preterm, growth restricted infants are often delayed~     due to concern that early introduction may not be tolerated and may increase the risk of~     necrotizing enterocolitis. However, prolonged enteral fasting may diminish the functional~     adaptation of the immature gastrointestinal tract and extend the need for parenteral~     nutrition with its attendant infectious and metabolic risks. Early introduction of small~     volumes of milk in the form of Trophic feeding, promote intestinal maturation, may enhance~     feeding tolerance and decrease the time taken to reach full enteral feeding independently of~     parenteral nutrition.~      A Randomized Trial will be carried out over a period of 12 months in Department of~     Neonatology of BSMMU. Sample size will be 50(25 in each group). Infants with gestation below~     35 weeks, birth weight below the 10th percentile for gestational age, will be randomly~     allocated by web-based randomization to commence enteral feeds early, whose feeding will be~     started from 24 to 48 hours of age or late, whose feeding will be started from 48 to 72~     hours of age. Gradually feeding will be increased. Rate of advancement of feeding will be~     same for both groups. Primary outcomes will be time to achieve full enteral feeding sustained~     for 72 hours. Statistical analyses will be performed by using Fisher Exact test and by~     Student's t test for categorical data and quantitative data respectively. Logistic regression~     analyses will be performed to determine the role of independent variable.~   "
9442|NCT03443284|"~     This is a prospective, mixed methods, multi-center, randomized, comparative, controlled~     study. Providence Health & Services will enroll a total of 296 subjects (18 years or older)~     who are electing to have total knee or hip replacement surgery. Subjects will be randomized~     to either the treatment group (Health Partner alongside standard care) or the control group~     (standard care alone). Health Partner is a combination of an iPhone or iPod Touch Operating~     System mobile application and a health care provider portal. The primary objective is to~     compare care plan adherence (pre- and post-surgery) for Health Partner vs. control subjects.~     Secondary objectives include evaluating all-cause medical resource utilization, communication~     with health care provider, well-being, fear of surgery, confidence in recovery from surgery,~     sleep, and patient satisfaction for 90 days post-surgery. To evaluate the behavioral factors~     associated with care path adherence using a qualitative interview method.To evaluate the~     usability and preferences of patients in their interaction with the intervention using a~     qualitative interview method, for product development.~      The total planned study duration is approximately 1 year and 7 months.~   "
9453|NCT03443141|"~     A prospective, randomized study will be performed. Patients are randomized using a 1:1~     allocation into 2 groups: patients receiving a vitamin E-containing dressing (group 1) and a~     conventional dressing (group 2). The primary outcomes variable will be occurrence of~     incisional SSI. Follow-up will be 30 days postoperatively.~   "
9454|NCT03443128|"~     The purpose of this study is to assess the efficiency and safety of vinorelbine in the~     treatment of relapsed / advanced ALCL in children and adolescents.~   "
9443|NCT03443271|"~     Random allocation of patients in two groups; Tap block group (T group) and control group (C~     group). All patients will receive standard general anesthesia and postoperative pain~     management. The TAP group patient will receive ultrasound guided (US) TAP block with 20 cc of~     0.25% of bupivacaine and control group will receive 20cc of normal saline. TAP block in both~     groups will be performed with US guidance and the study drug will be injected after complete~     visualization of the needle tip between the internal oblique and the transversus abdominis~     muscles.~      Venous blood samples (5 ml for each time) for metabolic and stress hormones, including, Serum~     cortisol and nor-epinephrine will be collected before anesthesia at the time of cannulation~     (T1),60 minutes after incision(T2), 6hrs (T3)and 12 h (T4) after the surgery.~      Postoperatively patient will be put on patient controlled intravenous infusion of nalbuphine~   "
9444|NCT03443258|"~     The study tests a needs assessment and decision-making tool with patients who are in need of~     rehabilitation after surgery for Head and Neck Cancer. The purpose is to enhance patient~     involvement in decision-making.~   "
9445|NCT03443245|"~     Currently, there is no reliable biomarker for stroke, meaning that treatment is often delayed~     and patients are often left with a disability. Stroke is one of the largest causes of~     mortality (death) and morbidity (disease) in the UK and affects around 120 and 15 people per~     100,000 population. This has huge economic implications, with around £9 billion a year being~     spent on stroke in the UK alone, and health and social care costs accounting for half of this~     amount. Productivity losses (i.e. income costs) are estimated at £1.33 billion and benefit~     payments total £840 million per year.~      Previous studies involving heart attack patients have suggested that succinate (a biomarker)~     levels rise after reperfusion (reoxygenation) of the heart tissue and in the context of~     ischaemia (i.e. when a restriction of blood supply to the heart has caused a heart attack and~     the tissue has been reoxygenated to improve blood flow around the body). Malonate is a~     therapeutic option to block this rise in succinate and reduce any potential resulting damage.~     Animal studies support these findings and have further shown that malonate prevents ischaemic~     brain damage and reduces the succinate increase in tissue.~      However, there is currently no pre-clinical data for the release of succinate into blood, nor~     for stroke. This study aims to explore whether elevated succinate levels are present in~     stroke patients having thrombolysis (brain reperfusion). If we can show that elevated~     succinate levels are attributed to stroke (and not a result of thrombolysis), it might be~     possible to identify a therapeutic intervention at baseline for these patients and this~     reduce disability in all stroke patients, and healthcare costs in turn.~   "
9446|NCT03443232|"~     A total of 106 patients with drug-refractory persistent atrial fibrillation, who are planned~     to undergo circumferential pulmonary vein isolation (CPVI), will be randomly allocated into~     two groups. These patients will receive cryoballoon ablation, radiofrequency ablation under~     the guidance of 3D mapping respectively (allocation ratio, 1:1). Atrial electrical activity~     including atrial effective refractory period, atrial conduction time, electromechanical~     conduction time, P wave dispersion and spatial dispersion of atrial refractory will be~     measured before and after the operation. Left atrial appendage flow velocity of all patients~     are measured by Transesophageal Echocardiography(TEE) 24 hours before the operation.~     Real-time ultrasound examinations of left atrial function are carried out for all patients~     before the operation and after the operation. Blood samples are extracted in all patients~     before the operation and after the operation.This study will clarify whether these different~     operation methods have different effects on the recovery of postoperative left atrial~     function and electrical activity in patients with persistent atrial fibrillation, and whether~     changes in left atrial function electrical activity are related to indicators such as~     inflammation, blood clotting and myocardial injury. Cryoballoons ablation is still less used~     to operate on persistent atrial fibrillation. To investigate the ablative effect, electrical~     remodeling and structural remodeling of persist atrial fibrillation with different operating~     methods. Therefore, the ablation is related indicators such as the success rate of the~     operation, intraoperative complications, postoperative recurrence rate and the amount of~     x-ray exposure are compared among two groups. At the same time, biochemical indicators of~     inflammation, blood clotting and myocardial injury such as blood routine, myocardial enzyme,~     BNP, troponin I and D-D dimmer are detected to analyze and determine which indicators are~     related to the postoperative recurrence of atrial fibrillation, the recovery of postoperative~     left atrial function.~   "
9447|NCT03443219|"~     The study compares the LMA Supreme™ versus the Spritztube® tracheal cannula in anesthetized~     adult patients.~      The current randomized study is designed to assess the success placement of blind insertion~     using LMA Supreme™ , in comparison with the Spritztube® tracheal cannula.~      In addition, time, number of attempts, easy insertion and the number of complications at~     insertion and removal will be assessed.~      The investigators hypothesize that the LMA Supreme™ versus the Spritztube® tracheal cannula~     will similarly perform during anesthetized adult patients despite differences in their~     structural design.~   "
9448|NCT03443206|"~     The goal of this study is to determine whether a community-based website that is intended to~     provide support for adolescents experiencing psychological distress can improve members'~     mental health outcomes. The investigators want to understand if a digital platform can help~     young people who are suffering and may be unlikely to access more traditional forms of mental~     health services.~   "
9449|NCT03443193|"~     The research project includes two components that assess exercise physiology parameters,~     cerebrovascular reserve, cognitive functions and cardiac function in coronary heart disease~     patients at rest, during an acute exercise, and after two different periodized training~     programs.~   "
9450|NCT03443180|"~     Siblings of those with type 1 diabetes are at an increased risk of developing the disease~     themselves. Through prior research, the investigators have found that siblings as well as~     those with type 1 diabetes have a general level of inflammation in the body. The~     investigators are examining the role that diet plays in this level of inflammation by asking~     siblings of children with type 1 diabetes to go on a gluten and Amylase Trypsin Inhibitors~     (ATI)-free diet for 4 weeks. Blood and stool samples will be measured before the diet, after~     the diet is completed and again 4 weeks after participants resume their normal diet.~   "
9451|NCT03443167|"~     Children's education students are able to identify a possible emergency and in their case act~     appropriately.~      The authors think that the propsed training will improve the knowledge, change the attitude~     and improve their practical skills, and also retain the information over time.~   "
9452|NCT03443154|"~     The purpose of this research study is to determine if a vaginal fluid (VF) test can predict~     very early preterm birth in patients who are scheduled to have an exam indicated cerclage for~     severe cervical shortening.~      Prior to participants undergoing a scheduled amniocentesis two swabs to collect vaginal~     secretions for the VF tests will be done. During the amniocentesis your doctor will remove~     amniotic fluid as part of the routine clinical care. From that fluid sample, the study will~     use less than a quarter teaspoon for the amniotic fluid study test (AF test). Data regarding~     maternal and birth outcomes will be collected by medical record review.~   "
9455|NCT03443115|"~     Retrospective cohort study including patients with genetically proven Duchenne muscular~     dystrophy, diagnosed from January 1993 to March 2020.~      Inclusion of the data relative to genetic diagnosis, clinical characteristics at baseline,~     cardiac and respiratory workup, medical treatments (ACE inhibitors, steroids), surgical~     procedures, and occurrence during follow-up of cardiac, respiratory and fatal events.~      Objectives are to describe long-term natural history of the disease, vital prognosis,~     genotype-phenotype correlations, effect of treatments.~   "
9456|NCT03443102|"~     SARS-CoV has caused severe epidemic respiratory disease in human populations. By July 2003, a~     total of 8,096 probable cases of SARS had been reported including 774 deaths in 27 countries,~     around one-third of which were health care workers (HCWs). Previous studies have been~     reported about long-term impacts of SARS infection, including lung function deficiency,~     steroid-induced osteonecrosis, reduced exercise capacity, and impairment in health-related~     quality of life (HRQoL). HCWs, especially nurses, have been reported to experience greater~     psychological distress, particularly increased levels of posttraumatic stress symptomatology~     (PTSS). But the very complex impacts of this fatal infection on HCWs have not been fully~     elucidated. It is thus important to follow these occupational patients to detect and manage~     multi-organ sequelae and functional impairment.~   "
9457|NCT03443089|"~     This clinical trial evaluated the comparative bioavailability of two injectable suspension~     formulations of medroxyprogesterone acetate + estradiol cypionate, a test (Depomês®, 25 mg/mL~     medroxyprogesterone acetate + 5 mg/mL estradiol cypionate, Biolab Sanus Farmacêutica Ltda.)~     and a reference formulation (Cyclofemina®, 25 mg/0.5 mL medroxyprogesterone acetate + 5~     mg/0.5 mL estradiol cypionate, Millet Roux Ltda.) in healthy female volunteers after a single~     intramuscular dose administration. In addition, this study also evaluated the safety and~     tolerability of these drugs.~   "
9458|NCT03443076|"~     This study will assess the relative bioavailability of 500 mg eicosapentaenoic acid (EPA) +~     docosahexaenoic acid (DHA) in a self-micro-emulsifying delivery system (SMEDS) formulation~     compared with a standard omega-3-acid ethyl ester product in healthy men and women.~   "
9459|NCT03443063|"~     This study will be conducted to assess the effect of severe renal impairment on the~     pharmacokinetics of lemborexant after a single-dose administration.~   "
9460|NCT03443050|"~     The objective of this study is to determine the effects on balance and postural control~     produced by the implementation of a training program that includes work with unstable~     surfaces in its methods. It also seeks to quantify to what extent the benefits exceed those~     achieved with a training of similar characteristics, but implemented on a stable surface. An~     intensive program is proposed, whose target population is young adults.~   "
9461|NCT03443037|"~     The study was a single center observational-prospective study and approved by local ethics~     committee. Patients in coma state due to traumatic brain injury, cardiac arrest or ischemic~     stroke who are older than 18 years of age were included in the study. Patients who received~     amantadine 200mg/day for fourteen days according to ICU protocols decided by primary~     physician formed the amantadine group, and the rest of the subjects were included in the~     control group. All patients were evaluated for Glasgow Coma Score, JFK Coma Recovery Scale~     and Disability Rating Scale once a week for three months.~   "
9462|NCT03443024|"~     The purpose of this study is to evaluate the safety and efficacy of lebrikizumab compared~     with placebo in patients with moderate-to-severe atopic dermatitis.~   "
9463|NCT03443011|"~     This study focuses on if low dose CT without intravenous contrast has a high enough~     specificity and sensitivity for acute diverticulitis that it can be used as the primary~     diagnostic method instead of a full dose CT with intravenous contrast which is the standard~     method in Sweden.~   "
9464|NCT03442998|"~     The investigators hypothesize that walking on a nature trail will lead to greater reductions~     in stress and greater improvements in the capacity to direct attention as compared to walking~     on a suburban sidewalk.~      The effects of walking in these different locations will be measured using physiological and~     psychological outcomes. The study design is a randomized with-in person cross-over trial.~     Subjects will take six 50-minute walks, one walk per week for six weeks. Three walks will~     occur in the urban setting and three in the nature setting. The order of the conditions will~     be randomly assigned to each subject, so that half of the subjects will complete the urban~     walks first and half the subjects will complete the nature walks first. There will be a~     two-week washout period between the two sets of walks. Day of the week will be fixed within~     person, and walks will occur during the mild weather months. In the case of inclement~     weather, the weekly walk will be skipped and an additional week will be added to the~     schedule. Limiting the frequency to one walk per week maximizes feasibility of the protocol~     and minimizes training effects, with any training effects over time being handled primarily~     by randomization (condition order is balanced), but also in the statistical analysis.~   "
9465|NCT03442985|"~     This is a randomized, double-blind, placebo-controlled study comparing the safety and~     efficacy of 2 dosage regimens of palovarotene versus placebo in preventing disease~     progression in pediatric subjects with multiple osteochondromas (MO).~   "
9466|NCT03442972|"~     Some of the fat (triglyceride) from the food humans eat gets stored in the bowel. This~     triglyceride can then be released into the blood when another meal is consumed or in response~     to hormones. How the gut hormone glucagon-like peptide-2 (GLP-2) releases the triglyceride~     from the gut is not known. The research team in this study is interested in finding out how~     teduglutide (a degradation resistant form of GLP-2) releases stored triglyceride from the gut~     by studying samples from patients undergoing endoscopy and small bowel biopsy.~   "
9536|NCT03442049|"~     Gait and mobility are among the functions frequently affected in Multiple Sclerosis (MS) and~     have a negative impact on quality of life. Strength losses in lower limb muscles, ataxia,~     sensory problems and fatigue are the most important reasons of walking problems in patients~     with MS. In addition to loss of strength and tonus problems, especially biomechanical~     disorders can be seen on foot and this problem affects gatin and balance negatively. The~     stabilizing muscles, defined as the core region and enveloping the body like a corset, are~     active in the context of postural preparation prior to lower extremity movements and~     stabilize for the limb movements to be performed. The aim of this study was to investigate~     the effects of spinal stabilization exercises on walking performance, fatigue, plantar~     pressure distribution, balance, muscle strength and quality of life in patients with Multiple~     Sclerosis.~   "
9467|NCT03442959|"~     Small Intestinal neuroendocrine Tumors (SiNETs) incidence is rising. Most of siNETs primaries~     are localized in jejunum/ileum. At the diagnosis, 50-70% of them present either lymph node~     (LN) and/or liver metastases (LM). It is admitted that almost 30% of the patients present or~     will present primary complications. Primary complications include endoluminal obstruction~     and/or LN-fibrotic mesenteritis with occlusive symptoms, and less frequently haemorrhage~     and/or intestinal ischemia.However, it is not clear weather this affects patient with or~     without multiple liver metastases (LM). In this regard, many centres propose to perform~     primary resection even in patients presenting unresectable LM. Thus, systemic reviews suggest~     a possible benefit of the primary midgut siNETs resection even in patients with unresectable~     LM, there is no prospective randomized trial showing the benefit of primary resection in such~     patients especially those who are totally asymptomatic. Indeed, all retrospective published~     series have several limitations and the results should be therefore considered with caution.~      Theoretical impact of preventive resection of midgut primaries in patients with~     unresectable LM and totally free of occlusive symptoms is controversial. Firstly, it is to~     avoid primary mechanical complications, and secondly to allow targeting therapeutics to the~     liver compartment. In this regard, in patients with synchronous unresectable LM from siNENs,~     ENETS, UKINETS, NANETS guidelines propose, in a case-by-case selective approach, the~     resection of the primary, while NCCN guidelines advocate to do not propose primary resection~     in such patient if they are free of symptoms with low tumor burden.~   "
9468|NCT03442946|"~     Malnutrition is common among critically ill patients, and has negative effects on clinical~     outcomes. Artificial nutrition therapy in the form of enteral or parenteral nutrition is~     therefore considered an integral part of standard care. While it has long been widely~     accepted that it is unethical to withhold nutrition therapy from those at risk of~     malnutrition, we and our collaborators provide first evidence that nutrition practices~     significantly influence clinically important outcomes such as length of stay, morbidity and~     mortality in critically ill patients. Among these, cardiac surgery patients are routinely~     exposed to significant systemic inflammation due to the need for a cardiopulmonary bypass,~     which triggers a systemic inflammatory response syndrome. As a consequence, the releases of~     reactive oxygen and nitrogen species as well as pro-inflammatory cytokines lead to~     life-threatening complications in cardiac surgical patients. For such patients, aggressive~     life-sustaining therapies are needed while their organs recover.~      Besides, underfeeding is a major issue in this specific patient population. Often nutrition~     starts late and reaches only low nutrition adequacy. Recent data from our collaborators~     suggest that providing at least 80% of prescribed amounts of protein and energy is associated~     with improved clinical outcomes. Achieving this threshold of 80% of prescribed amounts of~     protein has been shown to be associated with reduced mortality in at-risk ICU patients and~     is more important than achieving energy goals. Despite these benefits, enteral or parenteral~     feeding should always be adopted with caution, as nutrition practices themselves are not per~     se without adverse effects or risks. Making decisions regarding the most effective and safe~     means of feeding patients in the ICU can be challenging, and consequently considerable~     variation exists in nutrition practices in this setting, whereas no guidelines yet exists~     specific of cardiac surgery patients.~      Clinical Practice Guidelines (CPGs) are systematically developed statements to assist~     practitioner and patient decisions about appropriate health care for specific clinical~     circumstances, and therefore aid in the implementation of evidence-based medicine. The~     Canadian Clinical Practice Guidelines for Nutrition Therapy in Mechanically Ventilated,~     Critically Ill Adult Patients published in 2003 by our close collaborator Prof Heyland and~     most recently updated in 2015, sought to improve nutrition practices in ICUs across Canada~     and worldwide by providing guidance to select and deliver the most appropriate form of~     nutrition therapy at the appropriate time via the most appropriate route. A validation study~     prior to the widespread dissemination of the Canadian Critical Care Nutrition CPGs concluded~     that adoption of the recommendations should lead to improved nutrition practices and~     potentially to better patient outcomes [24]. To change clinical practice, attention must~     extend beyond initial development to guideline implementation, dissemination and evaluation.~     Implementation strategies will vary by ICU, health care system and region and should be~     guided by local factors including the ICU's barriers and facilitators to following best~     practice. Evaluating and monitoring nutrition performance and focussing on different groups~     of critically ill patients, should be part of an on-going improvement strategy to improve~     nutrition care and clinical outcome. The few studies regarding the process of knowledge~     translation conducted in the ICU setting have demonstrated by our collaborators that~     guidelines and guideline implementation strategies improve the processes, outcomes, and the~     costs of caring for critically ill patients.~   "
9469|NCT03442933|"~     The two most important problems of the musculoskeletal system in cyclists are low back pain~     (60%) and knee pain (33%). There is no clear hypothesis about the development of low back~     pain in cyclists, but several authors agree that it may be due to the maintenance of a~     maintained posture, with the lumbar spine in inversion and the characteristics associated~     with this sport (long duration, static posture, high intensities), so it is recommended a~     preparation of the musculature (strength-endurance work) and exercises to improve the~     postural scheme in the cyclist.~      The project proposes to analyze the acute effect of a long-lasting bicycle trip (3 hours) on~     the muscles involved in low back and knee pain, see, lumbar paravertebral, quadriceps and~     hamstrings, by means of tensiomyography (TMG).~   "
9470|NCT03442920|"~     The aim of this study was to evaluate the effect of obesity and exercise on periodontal and~     biochemical parameters [serum, saliva and gingival crevicular fluid (GCF) adipokines~     (interleukin-1β, tumor necrosis factor-α, leptin, resistin and adiponectin)].~   "
9471|NCT03442907|"~     The aim of this research project is to find out whether a personalized definition of the~     lower blood pressure threshold based on the individual blood pressure profile by means of~     preoperative 24-hour blood pressure measurement can reduce organ damage (brain, kidney,~     heart) through reduced blood flow during surgery.~   "
9472|NCT03442894|"~     This trial will investigate the benefit of trigger point dry needling (DN) for individuals~     with a common cause of shoulder pain - sub-acromial pain syndrome. Sub-acromial pain~     syndrome, also knowns as SAPS, is one of the most common causes of shoulder pain. Physical~     therapy treatments are routinely used for treating SAPS. One treatment approach that has been~     shown to be beneficial is a combination of exercises and manual or manipulative therapy. This~     approach has been shown to reduce pain and improve overall shoulder function in individuals~     with SAPS.~      Recently, a novel treatment approach for SAPS has emerged that involves trigger point DN to~     muscles of the shoulder and ribcage. Some studies have shown promising results for this~     approach while others have not found it to be helpful. Overall there is currently little~     research available on the benefit of trigger point DN for individuals with SAPS.~      This study will investigate whether adding trigger point DN to a treatment program of~     exercise and manual therapy provides any benefit to individuals with SAPS. To answer this~     question, this study will divide subjects into three groups. One group will receive just~     exercise and manual therapy; one group will receive manual therapy and exercise plus trigger~     point DN and one group will receive manual therapy and exercise plus a sham trigger point DN~     treatment.~      All patients receiving treatment in the study will attend 10 visits to a physical therapy~     clinic over a 6-week period. Subjects in the dry needling and sham dry needling groups will~     receive 6 sessions of this treatment in addition to their 10 sessions of exercise and manual~     therapy.~      The investigators will assess the effectiveness of the three treatment protocols by measuring~     patients pain, shoulder function and disability levels. These outcomes will be assessed at~     baseline, six weeks, 6 months and one year from enrolling in the study.~      In addition to assessing clinical outcomes following treatment, the investigators will assess~     the amount of health care utilized by each participant in the year following enrollment in~     the study. The 3 groups will be analyzed to determine if there is a difference in the amount~     or type of additional healthcare utilized in the year following study enrollment. Examples of~     healthcare utilization include x-rays, medication and/or surgical procedures.~      The investigators hypothesis is that individuals that receive actual trigger point DN in~     addition to manual therapy and exercise interventions will demonstrate greater improvements~     in pain, shoulder function and disability when compared to individuals receiving exercise and~     manual therapy alone or exercise and manual therapy with sham needling. The investigators~     think these differences in clinical outcomes will be present at each of the follow-up points.~     Additionally, the investigators hypothesize that individuals receiving actual DN will use~     less healthcare than those in the other two groups.~   "
9473|NCT03442881|"~     All participants will be subjected to Serum measurements of CA-125 by the immunoradiometric~     assay, Ultrasound evaluation of the Adnexal masses which is described according to origin~     (ovarian/extraovarian); position (right/left/bilateral); number of lesions; type of lesions~     (unilocular/multilocular); size in three dimensions (longitudinal, anteroposterior and~     transverse diameters); intracystic fluid echogenicity; number of loculations; presence and~     size of septations (only thickest one of septations is considered); presence, number and size~     of solid papillary projections (largest thickness is considered); presence and size of the~     largest solid component (three diameters); presence and measurement of fluid volume in the~     posterior cul-de-sac and presence and location of lesions suggestive of metastases. Then~     surgical intervention will be done with pathological examination of the specimen~   "
9474|NCT03442868|"~     The study aims to identify neural locus critical for dual-task walking (walking and talking)~     in individuals with stroke. To achieve this aim, the investigators apply repetitive~     transcranial magnetic stimulation (rTMS) to different parts of the brain and evaluate the~     effects of brain stimulation on dual-task walking speed.~   "
9475|NCT03442855|"~     Prospective observational (non-interventional) cohort study, multi-centric in 5 study Centers~     in Japan to collect short term clinical and radiological results of the cementless Bicontact®~     E stem in a standard patient population used in routine clinical practice~   "
9476|NCT03442829|"~     This study will assess the impact of repeated sweet breakfast consumption versus repeated~     non-sweet breakfast consumption on subsequent sweet and non-sweet food preferences and~     intakes~   "
9477|NCT03442816|"~     This research project aims to evaluate use in a clinical context of a novel imaging~     instrument, the Metabolic Hyperspectral retina Camera (MHRC) from Optina Diagnostics. This~     camera enables the acquisition of retinal images at multiple colors (up to 100 specific~     colors) and therefore extract way more information that can be captured with a conventional~     retinal camera (up to 3 colors). This additional color information available for each pixel~     of the image could be useful to identify signs of pathologies having manifestations in the~     retina. The performances of this new prototype camera will be evaluated and the acquisition~     procedures optimized in a diverse population of subjects.~   "
9478|NCT03442803|"~     There exists continued controversy over the use of propofol in Emergency Department~     procedural sedation, this is despite its widespread existence in clinical practice for at~     least a decade. These concerns are not limited to the ED setting and are primarily related to~     the pharmacological properties of the drug itself and its potential for harm. The bolus~     administration of propofol, aimed at a target of sedation, offers several advantages over~     more traditional agents, yet these advantages are also its limitations. The use of a~     target-controlled infusion may provide the sedationist with greater control over the~     pharmacokinetics of propofol and thus reduce the rate of adverse incidents.~      This feasibility study aims to use a pragmatic design to test the safety and efficacy of~     propofol TCI whilst assessing the practicalities of it's use in the ED. If it proves to be~     feasible then the researchers plan to proceed to a multi centre pilot study to gather~     information to adequately power a larger randomised multi centre trial.~   "
9479|NCT03442790|"~     Central venous lines insertion are common procedures these days. CVL placed under USG~     guidance have high success rates and low complications even in developing country settings.~     However, the investigators still have to rely on chest x-ray (CXR) to confirm the correct~     placement of central venous lines as a gold standard method. This might be time consuming and~     may cause delay in initiation of treatment. In some cases, as in operating room, the~     treatment is started even before confirmation by CXR. Ultrasound has ability to localize the~     tip of the catheter at the superior venacava- right atrium junction using agitated saline and~     the appearance of contrast within 2 seconds in right atrium. However, this technique is~     rarely used. The investigators, therefore, designed the trial to study whether confirmation~     of tip of CVL by ultrasound is non-inferior to the CXR confirmation.~   "
9480|NCT03442777|"~     The objective of this study is to determine if silicone adhesive multilayer foam dressings~     applied to the sacrum, heels and greater trochanter in addition to standard prevention reduce~     pressure ulcer incidence category II, III, IV, Unstageable and Deep Tissue Injury (DTI)~     compared to standard pressure ulcer prevention alone, in at risk hospitalised patients. In~     particular, this trial extends previous trial results obtained in ICU setting. Therefore,~     only a maximum of 25% of patients will be recruited from ICU settings.~      The hypothesis is: 'The use of silicone adhesive multilayer foam dressings as adjuvant~     prophylactic therapy for pressure ulcer prevention is more effective in reducing pressure~     ulcer category II, III, IV, Unstageable, and Deep Tissue Injury (DTI) incidence rate on~     sacrum, heels and greater trochanter, compared to standard pressure ulcer prevention alone.'~     The null hypothesis is: 'The use of silicone adhesive multilayer foam dressings as adjuvant~     prophylactic therapy for pressure ulcer prevention is not more effective in reducing pressure~     ulcer category II, III, IV, Unstageable, and Deep Tissue Injury (DTI) incidence rate on~     sacrum, heels and greater trochanter, compared to standard pressure ulcer prevention alone.~   "
9481|NCT03442764|"~     This is a multicenter, exploratory, randomized, double-blind study of the administration of~     mavacamten in 60 participants with symptomatic nHCM randomized to receive a 16-week course of~     mavacamten doses titrated to achieve 1 of 2 target drug concentrations.~   "
9482|NCT03442751|"~     To evaluate the safety and efficacy of epithelium-on corneal collagen cross-linking (CXL) in~     preventing the progression of, and/or reducing corneal curvature (Kmax) in eyes with~     progressive keratoconus. Epithelium-on CXL uses a formulation that allows the riboflavin to~     penetrate the cornea without the need to remove the epithelium, the outer most layer of the~     cornea.~   "
9483|NCT03442738|"~     The aim of this study is to evaluate the effect of ENDOCUFF VISION® (caps with soft, about 1~     cm long lateral feet of rubber (Endocuff) to flatten the colon folds) on ADR in a real-life~     setting (general practices) and in a homogenous patient collective (screening colonoscopies~     only).~      It is a prospective randomized multi centric study, with participation of at least 10 study~     sites (private practice). The study is an inverstigator-initiated trial (IIT).~      Depending on the randomization (closed envelope), the patients are examined with the standard~     instruments without or with ENDOCUFF VISION®.~      Group 1: screening colonoscopy with standard colonoscopes with ENDOCUFF VISION® Group 2:~     screening colonoscopy with standard colonoscopes without cap~   "
9484|NCT03442725|"~     Renal excretion is a minor elimination route of telotristat etiprate. So this trial is~     intended to assess the drug behaviour in subjects with decreased renal function.~      This is a staged study with Part B contingent upon the results of Part A. Part A will enrol a~     total of 16 subjects, eight with severely impaired renal function and eight healthy subjects.~     Part B with enrol a total of 16 subjects, eight subjects in each additional renal function~     group, i.e. mildly impaired renal function group and moderately impaired group.~   "
9485|NCT03442712|"~     Obesity is a common global health problem. A three-arm randomised waitlist-controlled~     feasibility trial is proposed. A total of 54 subjects (18 subjects per arm) will be~     recruited. The three groups are AA plus smartphone application (experimental group); AA only~     (comparison group); and Waitlist control group. In the experimental group, seeds will be~     applied on six specific ear acupoints of the subjects by the researcher. Subjects will be~     requested to apply pressure on the acupoints thrice per day. They will install a smartphone~     App which will send out regular reminders for pressing, allow the subjects to input the~     number of bowel open, compliance rate, and difficulties entered during the process for timely~     advice. The total treatment period will be 8 weeks. Outcome measures will be conducted at~     baseline and postintervention at 8 weeks, including obesity and anthropometric index, leptin~     concentration and adiponectin level. Patient satisfaction towards the therapy, the use of the~     smartphone application and the implementation of the treatment protocol will be determined.~   "
9553|NCT03441802|"~     Background: The Mediterranean Diet (MD) is considered an healthy diet useful in the~     prevention of cardiovascular disease (CVD). High quality extra virgin olive oil (HQ-EVOO,~     [1]), an essential component of this diet, exerts a protective effect against CVD. Moreover,~     the gut microbiota (GM) has recently been recognized as a key factor in driving metabolic~     activities and involved in the stimulation of host immunity [2]. In particular, Lactic Acid~     Bacteria (LAB) and their probio-active cellular substances produce beneficial effects in the~     gastrointestinal tract, thus representing important assets in pathological conditions such as~     obesity and CVD [3,4].~      Objective: The purpose of this study is to demonstrate that 3 months of treatment (MD with~     40g/die HQ-EVOO) in 36 subjects (cases: overweight/obese vs controls: normal weight) may~     change their GM and inflammatory panel.~   "
9486|NCT03442699|"~     Suicide is a major public health problem. Although inpatient treatment provides immediate~     stabilization and crisis management, the risk of suicide post-discharge is substantial.~     Approximately one third of all suicides by individuals with mental disorders occur in the 90~     days following hospitalization. Cognitive behavioral therapy (CBT) has been shown to reduce~     both suicidal ideation and behavior in outpatients. However, to date, the efficacy of~     inpatient CBT for suicide prevention is not clear. This study aims to 1) develop and~     implement a brief CBT treatment for suicide prevention for inpatients, 2) conduct a brief~     feasibility test and collect initial pilot data on efficacy, and 3) collect preliminary data~     on the effects of CBT on implicit cognitive suicide associations. In Phase 1, the~     investigators will work with an expert in CBT for suicide prevention to modify his treatment~     protocol for use with inpatients, and meet with this expert for a 2-day protocol training. In~     Phase 2, the investigators will conduct an initial feasibility trial with 5-10 inpatients~     recruited from the Institute of Living inpatient units. Participants will be recruited within~     24 hrs of admission or later and will provide written informed consent prior to any study~     procedures. Enrolled participants will undergo a clinical assessment by an independent~     evaluator (IE) that will include diagnostic/symptom assessments, assessment of suicide risk~     using the Columbia-Suicide Rating Scale, and an implicit association test (IAT). Participants~     will receive up to 10 daily sessions of CBT (depending on length of stay), lasting 1 hour,~     following the manualized protocol developed in Phase 1. Participants will then meet with the~     IE again for reassessment after the 10th session or within 24 hr prior to discharge,~     whichever comes first. After discharge, participants will have a telephone interview at 1~     month, 2 month, and 3 month follow-up. The IE will administer the C-SSRS during these calls.~     The proposed study will yield feasibility and initial efficacy data that will be used to~     inform a grant proposal to the American Foundation for Suicide Prevention. That proposal will~     fund a randomized controlled trial of CBT vs. treatment as usual. Concurrently, the~     investigators will develop an in-house program to train other staff in the protocol, and will~     submit a second grant to investigate the efficacy of the training program as well as the~     efficacy of CBT by those clinicians.~   "
9487|NCT03442686|"~     The Compass Course is an 8-session progressive structure that was developed based on~     theoretical and scientific evidence from psychology and occupational therapy. The goal of the~     intervention is to provide participants with information, tools, and support that help them~     move towards reclaiming a sense of self-grounded purpose in daily life. The study will use a~     convenience sample of breast cancer survivors to evaluate the efficacy of the Compass Course~     intervention.~   "
9488|NCT03442673|"~     This study aims to demonstrate that the mobilization with cytokine stimulation with G-CSF~     alone is non-inferior as compared to the standard mobilization with chemotherapy and G-CSF~     while associated with fewer side effects in myeloma patients.~   "
9489|NCT03442660|"~     The purpose of the study is to describe the psychometric properties (validity, reliability~     and responsiveness) of the SQOL-6D instrument in the context of routine clinical treatment of~     upper limb spasticity.~   "
9490|NCT03442647|"~     The number of people with kidney disease is constantly rising and renal failure represents~     one of the major health care burdens globally. An accurate measurement of kidney function is~     urgently needed to better understand and treat loss of renal function. Kidneys have an~     intrinsic reserve capacity to respond to a higher work load by increasing filtration in their~     nephrons. The number of nephrons and their reserve capacity define how well kidneys can adapt~     to an increased demand and disease.~      The degree of renal reserve capacity becomes particularly important when the number of~     functioning nephrons is significantly reduced either due to surgical removal of one kidney as~     in living kidney donation or in tumor nephrectomy or due to progressive injury as in~     autosomal dominant polycystic kidney disease (ADPKD). A reduced functional reserve likely~     reflects an impaired adaptive capacity and increased risk of accelerated loss of function in~     the remaining single kidney or in kidneys exposed to a disease. Despite the importance of~     accurately measuring baseline and reserve capacity renal function, due to the time- and~     laborintensive procedure, in clinical routine this testing is rarely done.~      Investigators aim to measure renal functional reserve (RFR) and loss of function in patients~     undergoing nephrectomy (living kidney donors and renal tumor patients) as well as in patients~     with ADPKD.~      The results should provide evidence whether renal functional reserve indeed predicts adaptive~     capacity and functional loss after removal of a healthy kidney (living donors), of a tumor~     kidney (cancer patients) or in progressive kidney disorders (ADPKD patients).~      Investigators are confident that the proposed project will enhance the understanding of~     progressive kidney disease and with this improve donor safety, planning of tumor nephrectomy,~     and prediction of renal functional loss as well as provide a strong argument that dynamic~     renal function testing, i.e. accurate measurement of baseline and reserve capacity, is~     necessary in certain disease entities.~   "
9491|NCT03442634|"~     this study helps us to compare and evaluate prospectively the benefits and safety of early~     hydration on bowel movement after cesarean section it includes two groups, a control group~     and a study group. the study group will get 200 ml of sugar free water within 1 hour after cs~     while the control group will get 200 ml of sugar free water 6 hours after cs~   "
9492|NCT03442621|"~     This is an open-label, randomized, single-dose, 3-period crossover, Williams' design,~     food-interaction (fasted and fed arms) study conducted in healthy subjects.~   "
9493|NCT03442608|"~     This study is a prospective, multi-centre, randomized,controlled trial to compare the~     efficacy of long-term mild hypothermia with normothermic intensive management in patients~     with poor-grade aneurysmal subarachnoid hemorrhage.~      The primary hypothesis is that the induction of mild hypothermia (maintained at 32-35℃) for~     at least 5 days would improve the outcome of patients at six months post hemorrhage compared~     with normothermia.~   "
9494|NCT03442595|"~     The MedStar Diabetes Pathway (MDP) is transitioning into a clinical program offered at~     various MedStar sites. The MDP clinical team is reviewing the data collected during the pilot~     to improve the program and adapt it to various clinical settings in order to better serve the~     target patient population. It is imperative to continue reviewing patient clinical outcomes~     as the program expands in order to insure continuous quality improvement of the program. This~     will be achieved through chart reviews of patients receiving diabetes care via the MDP and~     comparison with patients received diabetes standard of care through their primary care~     physician.~   "
9495|NCT03442582|"~     The study is a population based prospective cohort study designed to collect data on~     pregnancy outcomes and events of interest among women immunized with Afluria during~     pregnancy.~   "
9496|NCT03442569|"~     To investigate the combination of nivolumab and ipilimumab with panitumumab in subjects with~     unresectable, refractory, KRAS/NRAS/BRAF wild-type, microsatellite stable (MSS) metastatic~     colorectal cancer.~   "
9497|NCT03442556|"~     This phase II trial studies how well docetaxel, carboplatin, and rucaparib camsylate work in~     treating patients with castration resistant prostate cancer with homologous recombination~     deoxyribonucleic acid (DNA) repair deficiency that has spread to other places in the body.~     Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop~     the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Rucaparib camsylate may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Giving induction docetaxel and~     carboplatin followed by maintenance rucaparib camsylate may work better in treating patients~     with castration resistant prostate cancer.~   "
9554|NCT03441789|"~     This study seeks to show whether there is a benefit of prescribing Enstilar with Otezla in~     the treatment of patients with moderate plaque type psoriasis. Subjects will be randomized to~     study treatment at a 1:1 ratio of Otezla plus Enstilar foam versus Otezla plus vehicle foam.~   "
9498|NCT03442543|"~     A question is raised about the possibility of accurate localization of the SLN (sentinel~     lymph node) detected by CTLG (Computed Tomography Lymphography) which offers a detection rate~     of 100% in many studies In Oncology center, Mansoura University (OCMU), the surgical oncology~     unit had a previous experience in using charcoal for localization of non-palpable suspicious~     breast lesions and it showed promising results in comparison to traditional localization~     methods In addition, we had another study using silver wire for localization of breast masses~     before neoadjuvant therapy.~      In the study, the investigators will study the usage of both methods as preoperative~     localization methods for the SLN detected by CT lymphography in breast cancer patients The~     investigators suppose that this method can offer two main advantages over the traditional SLN~     intraoperative methods which are; saving operative time needed for the intraoperative~     procedure as well as solving the problem of the need for complex logistic preparations~     especially for the usage of radioisotope method.~   "
9499|NCT03442530|"~     The proposed project will test the effectiveness of the novel delivery of an established~     tobacco cessation treatment among pregnant women in Kentucky. Tobacco use during pregnancy is~     one of the most modifiable risk factors associated with poor birth and maternal outcomes and~     yet smoking prevalence among pregnant women in Kentucky is among the highest in the county~     and estimated to be twice that of the national average, with no meaningful declines observed~     in twenty years.~   "
9500|NCT03442517|"~     The purpose of this study is to learn if group-based phone counseling is effective for~     increasing breastfeeding rates, reducing the early introduction of solids and increasing~     maternal weight loss after pregnancy.~   "
9501|NCT03442504|"~     Clinicians are currently proposing second-line hormonal treatment to a metastatic patient who~     is progressing after first-line hormonal therapy if the initial disease was RH + with an~     increase in survival without recurrence more or less long. The biopsy of the metastatic site~     or sites is rarely performed because of the heaviness of the gesture. Clinicians are waiting~     for imaging, which can replace biopsy before the second-line metastatic hormone treatment in~     breast cancer, which will reveal the metastatic lesion heterogeneity allowing to establish if~     hormone therapy is the best therapeutic option for these patients and therefore lead to a~     personalized medicine driven by PET FES. This imaging approach seems all the more interesting~     as ER expression appears to evolve over time under the pressure of treatment or the natural~     evolution of carcinomas.~      Currently, no studies in breast cancer, in an ER + population on the initial tumor and Her2~     negative, are listed for the study of ER expression by PET FES before a second metastatic~     hormone treatment line.~   "
9502|NCT03442491|"~     Post-partum haemorrhage continues to be a leading cause of maternal mortality and morbidity,~     accounting for more than 125 000 deaths per year across the world. Prompt diagnosis and~     effective action are the cornerstones of management and are crucial to prevent fatal maternal~     haemorrhage.~      Considering that published data are extremely limited, the aim of our study will be to~     evaluate retrospectively the efficacy of Hayman's Haemostatic Suture for the treatment of~     resistant post-partum hemorrhage resistant to pharmacological therapy.~   "
9503|NCT03442478|"~     In March 2009, Health Canada approved Tomosynthesis for use in screening and diagnosis of~     breast cancer. The Tomosynthesis technology is designed as a complementary imaging model that~     is incorporated into the 2D Mammography system. This new imaging system has the capability to~     provide 2D, 3D and combination mode models. It consists of generating thin slice images that~     can be viewed individually as multiple images from the same breast. Tomosynthesis provides~     improved visibility of possible lesions within the breast. The study aims to compare the~     performance of Tomosynthesis to the conventional Digital Mammography in detecting and~     characterizing suspicious findings in subjects who will be having breast biopsies.~   "
9504|NCT03442465|"~     The purpose of this study is to look at the amount of function that returns in participants~     that have reconstruction with bone graft or artificial device and in participants who have~     tumor surgery plus regenerative osseous surgery.~      The study will look at the level of function for a period of 3 years after the surgery.~     Another purpose of this study is to look at how well the bone heals in participants~     undergoing regenerative surgery~   "
9505|NCT03442452|"~     The purpose of this study is to test the feasibility and preliminary efficacy of a novel~     electronic decision aid to improve AML patients' understanding of their illness, prognosis,~     and treatment options.~   "
9506|NCT03442439|"~     The purpose of this current study is to investigate the efficacy of a group model of Family~     Nurture Intervention in ameliorating behavioral problems in preschool-aged children. The~     behavioral, neurobiological and clinical insights gained from this project may eventually~     lead to better treatment of emotional, behavioral, and developmental disorders. The~     investigator hypothesizes that the children who are treated with Family Nurture Intervention~     (FNI), which incorporates interactive touch with vocal soothing, and family practice in~     comforting, will show increased emotional connection and mother child co-regulation with~     better results in the outcome measures in the short term and long term.~   "
9507|NCT03442426|"~     It is well known that older Canadians are high users of health care services. What is less~     well known is that the health care system is not well-designed to meet the needs of those who~     use it most. Older persons look to their primary care practitioners to assess their needs and~     coordinate their care. Unfortunately, the health concerns of older persons are often missed~     in too-short office visits. They may need care from a variety of providers and services, but~     this care is often not well-coordinated. Older persons and their caregivers are the experts~     in their own needs and preferences, but often do not have a chance to participate fully in~     treatment decisions or care planning. As a result, they may have health problems that are not~     properly assessed, managed or treated resulting in poorer health, as well as preventable and~     expensive emergency department visits and hospital stays.~      Improving the health of older Canadians means identifying health problems early. It means~     providing timely supports so that manageable concerns do not spiral out of control. And,~     above all, it means helping health care providers actively engage older patients and their~     family caregivers as partners in care. Patients want to make informed choices about their~     health and the care they receive, based on their personal values, preferences and goals, and~     informed by available evidence.~      Nine primary care clinics in three provinces (Quebec, Ontario, Alberta) will use a quick~     screening tool to identify older patients who are at risk of becoming frail. This will help~     initiate referral to health care or support services where necessary. Innovative technology~     will be used to streamline the referral process and help assist older adults in~     decision-making about their care.~      With support from the Canadian Frailty Network (CFN, formerly TVN), researchers,~     collaborators, health care providers and older adults from across Canada will work together~     to transform primary health care for frail elderly Canadians.~   "
9555|NCT03441776|"~     To prospectively evaluate the tools, environment and resources to compare the effectiveness~     of two different standard of care vestibular rehabilitation approaches in a military cohort~     with post-concussive vestibular symptoms.~   "
9508|NCT03442413|"~     Physically healthy adult smokers may be eligible for this study. Volunteers may participate~     in this study if they are 18 - 65 years old.~      Subjects will participate in two separate 10-hour PET/CT Scan Sessions (each with 2 hours of~     actual PET/CT scanning): one following an overnight abstinence and one following two~     overnights of abstinence. To achieve and confirm two overnights of abstinence, participants~     will present to the inpatient CHPS the day prior to the scheduled scan and stay overnight.~      The 2-[18F]-FA PET/CT brain scans will consist of an injection followed by an 8-hour infusion~     of 2-[18F]-FA. The scan session will begin at approximately 6 hours after the bolus~     injection. The PET/CT scan will be approximately 120 minutes long with a bolus injection of~     IV nicotine that will occur during scanning at approximately 30 minutes into the procedure.~     The pre and post nicotine images will be analyzed to evaluate for differences in receptor~     uptake after the nicotine challenge.~      Subjects will have a structural Brain MRI performed within 1 year of study enrollment.~     Subjects who have not had a Brain MRI that is deemed acceptable for use for this study will~     undergo a research Brain MRI.~   "
9509|NCT03442400|"~     Coronary artery blockages can reduce blood flow to the heart muscle. Fractional flow reserve~     (iFR or FFR) assessment is an invasive tool used to determine how much blood flow is reduced.~     The investigators will perform iFR/FFR on all intermediate coronary stenoses using standard~     practice, immediately before (at the time of) transcatheter aortic valve replacement (TAVR)~     and after successful TAVR. The investigators will compare pre- and post-TAVR iFR/FFR values,~     and assess short-term outcomes. The investigators hypothesize that iFR/FFR values will be~     consistently and significantly higher pre-TAVR in comparison with post-TAVR for the same~     lesions.~   "
9510|NCT03442387|"~     The aim of the study was to conduct three different parallel randomized controlled trials to~     assess how the different framing of Cochrane summary information (positive vs negative~     framing of health information) affects affect the perception of the efficacy and intention~     for use of the described treatment.~   "
9511|NCT03442374|"~     Low back pain (LBP) is a complex condition that affects 65-85% of the population, and is the~     leading musculoskeletal condition contributing to disability in the United States. Disc~     herniation is the most common injury and 75% of individuals undergoing surgical and~     rehabilitative interventions for this condition experience suboptimal or poor outcomes. These~     patients demonstrate disability and deficits in functional capacity, including strength and~     endurance of the lumbar musculature. Muscle-specific changes in individuals with LBP include~     altered muscle volume, fatty infiltration and fibrosis, and fiber area and type. Importantly,~     these changes are insensitive to rehabilitation in patients with continued chronic or~     recurrent symptoms. While normal disuse-related atrophy in the presence of LBP is expected,~     more severe or chronic pathology, such as inflammation and fiber damage, may be inducing~     irreversible fiber degeneration and fatty/fibrotic tissue changes that impair muscle function~     and recovery. While the structural and adaptive capacities of healthy muscle are well~     understood, muscle recovery in the presence of pathology is less clear. To address this gap~     in knowledge, the purpose of this project is to compare structural, physiological, and~     adaptive responses of muscle in the presence of acute and chronic lumbar spine pathology. The~     central hypothesis is that chronic injury results in a state of muscle inflammation, atrophy,~     fibrosis, and muscle degeneration that is not responsive to exercise. The Investigators will~     identify which patients respond to exercise by examining muscle hypertrophic, fibrotic,~     inflammatory, and adipogenic gene expression profiles. Patients will be followed for six~     months post-operatively to measure muscle recovery and strength.~   "
9512|NCT03442361|"~     Background: Intravenous lipid emulsions (IVLE) are an essential component of parenteral~     nutrition (PN). Omega-6 reducing strategies may improve outcomes, including reduced PN~     associated liver disease.~      Objective: The primary objective was to compare serum alkaline phosphatase (ALP), among~     surgical and medical patients provided with either Intralipid or Clinoleic lipid emulsions.~      Design: In this quasi-experimental study the medical records of surgical and medical adult~     patients were reviewed from 3 Canadian hospitals that received PN with either soybean oil~     (Intralipid) or predominantly olive oil (Clinoleic) based lipid emulsions for at least 7~     consecutive days.~   "
9513|NCT03442348|"~     Metabolic syndrome represents a major health burden worldwide affecting 20-30% of the~     population. This clustering of abnormalities that confers an increased risk of cardiovascular~     disease and type 2 diabetes mellitus, is the hallmark of unhealthy aging in longevity~     studies. Preventive strategies have so far failed since they have focused mainly on reducing~     caloric intake, ignoring the metabolic dysfunction in the aging body. The growing importance~     of the gut microbiota in all aspects of human health is clear, and unlike our genomes is~     potentially highly modifiable and tightly related to metabolic and immune efficiency, energy~     and fatty acid metabolism and satiety hormones. The investigators and others have reported~     that higher microbiome diversity correlates with significantly lower long-term risk of weight~     gain and metabolic syndrome. The investigators have recently shown that serum levels of~     omega-3 fatty acids correlate with higher microbiome diversity, and increased abundance of~     bacteria that produce butyrate are linked to lower inflammation of the gut. The investigators~     therefore propose to carry out a proof of concept nutritional intervention study in the~     TwinsUK cohort. The TwinsUK sample is probably the most detailed omic and phenotypic resource~     in the world and is ideal for this study. The mechanisms that result in improved microbiome~     composition and diversity will be explored in a highly focused novel interventional study~     hypothesizing that key fatty acid pathways are crucially involved in the link between diet,~     microbiome, immune phenotypes and metabolic syndrome. The specific objectives are to measure~     changes in gut microbiome composition in response to fibre supplementation compared to~     omega-3 fatty acid supplementation. The study will measure faecal metabolites relevant to~     fatty acid metabolism (short chain fatty acids), the abundance of microbial species linked to~     higher or lower inflammation and immune cell phenotypes to unravel the link between~     inflammation, diet and metabolic syndrome. There is a real lack of good diet intervention~     studies in this field and if successful this trial will pave the way to funding a wide~     variety of other diet intervention studies.~   "
9524|NCT03442205|"~     ABSTRACT Introduction: Common bile duct (CBD) stone is a common clinical situation,~     especially in Asia area. Laparotomy and laparoscopic surgical procedure are often used for~     treatment. This study compares outcomes of different surgical procedures treating for the~     disease.~      Methods/design: This is a prospective, randomized, controlled multicenter trial with three~     treatment arms. One group underwent laparoscopic cholecystectomy (LC) + laparoscopic CBD~     exploration (LCBDE) + intraoperative endoscopic nasobiliary drainage ENBD + primary closure~     of CBD. The other underwent preoperative endoscopic retrograde cholangiopancreatography~     (ERCP) and subsequent LC and the third arm underwent laparoscopic cholecystectomy (LC) +~     laparoscopic CBD exploration (LCBDE) + primary closure of CBD. The duration of the entire~     trial is two years including prearrangement, follow-up and analyses.~      Discussion: Despite the fact plenty evidences provided by meta-analyses suggests that these~     approaches would appear comparable. It is hopeful to fully address which would be the better~     approach with this RCT design.~   "
9514|NCT03442335|"~     Background Miscarriage is the most frequent complication of pregnancy and represents the~     spontaneous loss of the embryo or foetus before it is able to survive independently (24 weeks~     of gestation). It affects up to 50% of pregnancies with the vast majority (80%) occurring at~     pre-clinical stage before the woman recognises the pregnancy. Up to 5% of couples suffer~     recurrent miscarriage defined as 2-3 or more miscarriages leading to physical, emotional and~     financial consequences for couples, doctors and medical systems.~      Different maternal health problems (thyroid disease, sticky blood, autoimmune disease,~     anatomical anomalies of the womb) and embryo defects may be responsible for some of the~     miscarriages; however, more than 50% of the occurrences have no identifiable cause based on~     the current diagnostic tests.~      Aim The aim of the present research proposal is to understand the role of the lining of the~     womb in miscarriage and to explore the development of a potential implantation test that is~     cost-effective and may be implemented in clinical practice.~      Methods Over a period of two years, women who suffered recurrent miscarriage will be~     approached in the advanced miscarriage clinic at Birmingham Women's Hospital during their~     routine appointment. Participants will be invited to participate by undergoing~     chromohysteroscopy and/or a biopsy from the lining of the womb during an outpatient~     appointment.~      Chromohysteroscopy is based on a routine hysteroscopy which involves visualising the inside~     of the womb using a narrow telescope passed through the neck of the womb (cervix). Chromo~     comes from the fact that an iodine based dye will be injected to increase the power of the~     test.~      The biopsy will be taken using a narrow plastic tube passed through the cervix. It is a~     standard diagnostic test for women with abnormal bleeding. As part of the present research,~     different cells and molecules will be analysed from the biopsy sample.~   "
9515|NCT03442322|"~     Of the 1.4 million nursing home (NH) residents in long term care facilities, more than half~     have Alzheimer's disease or dementia. Due to changes in their familiar daily routines,~     difficulty expressing their thoughts or asking for what they need, and overstimulation (such~     as noise) or under stimulation (such as lack of activity), individuals with dementia often~     display disruptive behaviors like resisting help or continually repeating the same phrases.~     Medications are often prescribed to reduce agitation and aggressive behavior; however, these~     medications may not be effective and can have a negative impact on the individual. Therefore,~     families and other stakeholders strongly advocate the use of other types of approaches that~     focus on minimizing the cause of the behavior. Two facility-based methodologies include the~     transdisciplinary approach for integrated dementia care, which combines the expertise of all~     NH staff, who work together to build a common language and approach for each resident, and~     the multidisciplinary approach for problem-based dementia care, in which each staff member~     conducts individual assessments and makes discipline-specific recommendations. While prior~     research suggests that both of these facility-based approaches are useful, the circumstances~     under which each approach is most effective are not clear. This project will prospectively~     randomize 80 nursing homes to one of the two treatment arms to compare the effect of the~     transdisciplinary approach versus the multidisciplinary approach.~      This study will examine the difference between the two comparators with respect to facility~     rates of medications dispensed to residents with dementia, leading to enhanced quality of~     life for the resident.~      This project is important because it will address a key clinical dilemma NH staff face as~     they strive to optimize the use of alternative approaches to reduce disruptive behaviors in~     residents with dementia. Transforming the quality of dementia care in NHs and enhancing the~     quality of life of residents with dementia are high priorities for families and other~     advocates.~   "
9516|NCT03442309|"~     Dental caries (tooth decay) is the most prevalent childhood disease in the world. Multiple~     interventions are available to treat and prevent caries. The aim of the proposed study is to~     compare the benefit of silver diamine fluoride (SDF) and fluoride varnish versus fluoride~     varnish and glass ionomer sealants. This study is a five-year, cluster randomized, pragmatic~     controlled trial conducted in public elementary schools in New York City.~   "
9517|NCT03442296|"~     Age-related hearing loss is highly prevalent and hearing health care is underutilized. The~     primary objective of the proposed randomized controlled trial is to investigate the efficacy~     of a community health worker (CHW)-delivered hearing loss intervention program. A preceding~     pilot study demonstrated preliminary effectiveness of the intervention program in reducing~     self-reported hearing handicap, and highlighted its acceptability among the target~     demographic. The proposed trial will now expand upon lessons learned through previous pilot~     studies and expand to other affordable residences for low-to-moderate income older adults in~     Baltimore. Primary outcome measurements will investigate intervention effects on hearing~     handicap, with secondary measurements investigating effects on domains such as social~     isolation and quality of life. This trial is a first-in-kind investigation of a novel~     community-based intervention that addresses hearing loss in a vulnerable, urban population.~   "
9518|NCT03442283|"~     The use of vitamin and mineral supplementation has historically been to treat and prevent~     micronutrient deficiencies. In recent years, however, and with their widespread use, the~     interest has shifted toward a possible role in the prevention and treatment of chronic~     diseases. The investigators will review and perform meta-analyses of vitamin and mineral~     supplementation trials in relation to cardiovascular disease. Publications from 2012, both~     before and including the US Preventive Service Task Force (USPSTF) 2014 review, will be~     included in the review.~   "
9519|NCT03442270|"~     An observational prospective will be conducted to determine the detection rate of serrated~     adenoma during screening colonoscopy at our institution. Additionally, the variability of~     serrated adenoma detection among endoscopists will be evaluated and the characteristics of~     serrated adenomas will be described.~   "
9520|NCT03442257|"~     The primary objective of the study is to examine the impact of lifestyle advices,~     administered through regularly sent SMS, on hypertension in a primary health care setting.~     The secondary objective is to evaluate changes in other cardiovascular risk factors and~     general health, e.g. tobacco use, obesity, blood lipids, blood glucose, self-rated health and~     health-related quality of life.~   "
9521|NCT03442244|"~     This trial is looking at whether the LEO 90100 foam causes irritation of the skin in healthy~     Japanese male adults without psoriasis. A single application of LEO 90100 foam and its~     vehicle will each be made to 2 body sites in 20 subjects.~   "
9522|NCT03442231|"~     This is a retrospective/prospective, open-label single cohort, multicenter study to collect~     relevant clinical data from 147 subjects with unicompartmental degeneration of the knee in~     whom the Journey UNI UKS was previously implanted.~   "
9523|NCT03442218|"~     To evaluate the rate of infections after cesarean sections in patients with premature rupture~     of membranes after vaginal wash either with an antiseptic solution (clorhexidine solution)~     vs. saline solution (placebo).~   "
9525|NCT03442192|"~     This research is being done to learn more about the differences in engaging, recruiting,~     linking and adhering to pre-exposure prophylaxis (PrEP) services for men who have sex with~     other men at risk for HIV in Baltimore City.~      In 2012, the U.S. Food and Drug Administration (FDA) approved the use of Truvada as~     pre-exposure prophylaxis (PrEP) to help prevent HIV infection. In the intervention, a~     virtual, PrEP Care Anywhere Telemedicine approach supported by virtual peer-navigator will be~     compared to standard clinic-based PrEP services with face-to-face peer navigation. The study~     will evaluate whether PrEP Care Anywhere, which is more patient-centered, will improve~     adherence and retention in PrEP care.~   "
9625|NCT03440840|"~     This study investigates the effectiveness of computer-based cognitive training with or~     without transcranial direct current stimulation (tDCS) in improving the functioning of older~     individuals with HIV-related cognitive dysfunction.~   "
9526|NCT03442179|"~     Brain activity can be inferred from brain waves that can be observed using a technology known~     as the Electroencephalogram (EEG). Anesthetic drugs change these EEG patterns. A patient's~     state of consciousness during general anesthesia is closely related to their EEG brain wave~     patterns, and these patterns are visible using existing EEG monitors that are readily~     available in the operating room. However, currently, most anesthesiologists do not use EEG~     brain monitors in their routine practice. During aging, the brain undergoes structural and~     functional changes that can increase a patient's sensitivity to anesthetic drugs, leading to~     an increased potential for delayed cognitive recovery following anesthesia and surgery. Safe~     delivery of anesthesia in elderly patients is of great importance. By using the EEG, the~     investigators can track brain activity during anesthesia and use it to provide a more~     personalized form of anesthesia care. In this study, the investigators are trying to~     understand if monitoring brain waves can help anesthesiologists administer anesthetic drug~     more precisely, specifically in elderly patients.~   "
9527|NCT03442166|"~     In dentistry, one of the most common surgical procedures is the removal of included third~     molars. This surgery generates great morbidity to patients for causing pain, edema and~     trismus due to surgical trauma. The use of photobiomodulation (PBM) (low-power laser or light~     emitting diode - LED) in the postoperative of these procedures has shown excellent results in~     the control of postoperative sequelae. The objective of the present study is to evaluate the~     effectiveness of PBM with LED in the control of pain, facial edema, trismus and quality of~     life resulting from the extraction of retained lower third molars. A randomized,~     double-blind, placebo-controlled clinical trial involving 34 adult patients, who search the~     Discipline of Buccomaxillofacial Surgery and Traumatology (CTBMF) II of FO-UFRGS for the~     removal of included lower third molars will be conducted. Before and after the surgeries, the~     facial and mouth opening measurements of all patients will be done. Immediately after the~     surgeries, the patients will be randomized by means of envelopes in two groups. In the LED~     group the patients will receive daily LED applications (intra oral with 660nm and extra oral~     with 850nm) from the immediate postoperative to 7 days after the surgical procedure. In the~     control group the patients will be treated in the same way as in the LED group, however, the~     person in charge of the application will simulate intraoral and extraoral irradiation with~     the LED kept off. Pain (EVA and NRS-101), postoperative edema, trismus, temperature,~     dysphagia and hematomas, as well as the impact of the surgical procedure on patients' quality~     of life will be evaluated after 1, 2, 5 and 7 days. For the analysis of the oral health~     impact profile (OHIP-14 Questionnaire) and anxiety analysis (Beck anxiety inventory -BAI) the~     questionnaires will be applied preoperatively and 7 days after treatment. Initial descriptive~     analyzes will be performed considering all variables measured in the study, both quantitative~     (mean and standard deviation) and qualitative (frequencies and percentages). Later, the~     appropriate statistical tests will be applied for each specific analysis. In all tests, the~     significance level of 5% probability or the corresponding p-value will be adopted. All~     analyzes will be performed using the statistical software SAS for Windows, version 9.1.3.~   "
9528|NCT03442153|"~     This study evaluates the effect of dietary supplement Solgar No7 in 76 adult Osteoarthritis~     of the Knee Patients, while the other half will receive placebo.~   "
9529|NCT03442140|"~     15 patients who have completed the Baylor Martha Foster Lung Center Pulmonary Rehabilitation~     Program at least six months ago will be selected to participate in a 12 week training program~     with six months of follow up.~   "
9530|NCT03442127|"~     The Internet-based program CaringGuidance™ After Breast Cancer Diagnosis and its new~     electronic Summary Report (CGSR) tool are hypothesized to empower patients to raise their~     emotional and social concerns during oncology consultations and assist medical oncology~     clinicians in identifying patient needs. The purpose of this study is to assess satisfaction~     and feasibility of clinical use of the new patient guided, Internet-based CGSR to support~     patient-clinician communication in the outpatient breast oncology clinic. The study will~     enroll 30 women who are receiving chemotherapy for breast cancer. They will all have access~     to the CaringGuidance™ program for at home use on computer or mobile device for approximately~     one month (or up to 6 months depending on when they return to their primary medical~     oncologist for evaluation). Following this, these women will meet with the researcher or~     research assistant prior to a medical oncology appointment and create a CGSR on an iPad while~     they talk through the process with the researcher. Women will complete demographic data and~     assessment of coping prior to receiving access to the program and at this appointment. These~     assessments will help characterize the emotional state at the time of working with the~     program and the CGSR, these measures are not to assess the efficacy of the program.~     Clinicians will complete a brief, one-time demographics survey prior to enrollment of~     patients to the study. Women will take the CGSR into their oncology appointment, record the~     appointment if she and the physician have consented to this, and use the CGSR as much or as~     little as desired. Clinicians will complete a brief satisfaction survey following the~     appointment and patients will debrief (recorded) about whether they used the CGSR and their~     impressions following the appointment. Data will be analyzed primarily qualitatively to~     determine women's appraisal of the functionality, content satisfaction and usability of the~     CGSR and the communication patterns, topics discussed during the appointment and~     patient/clinician satisfaction with communication during the appointment when the CGSR was~     available for use. Data will be used for future modification of the CGSR to assure that it~     meets patients' needs prior to initiating a larger scale trial.~   "
9531|NCT03442114|"~     The goal of the study is to understand how best to help parents of young children with sickle~     cell disease and their clinicians have a shared discussion about hydroxyurea (one that takes~     into account medical evidence and parent values and preferences). The study will compare two~     methods to help clinicians facilitate this—a clinician pocket guide and a clinician~     hydroxyurea shared decision making toolkit—in a group of parents of children ages 0-5 with~     sickle cell disease. The investigators hope that both methods lead to parents reaching a~     high-quality, well-informed decision. In addition, the team hopes to demonstrate that parents~     who experience a shared decision will have lower anxiety and decisional uncertainty. The~     researchers also expect these parents to be more likely to choose hydroxyurea and that their~     children will have less pain, fewer hospitalizations, better developmental outcomes, and~     higher quality of life. The project team hopes to show that the toolkit method is easy for~     clinicians to use and gives parents the support needed to make an informed decision.~   "
9532|NCT03442101|"~     Psychosis is a heterogeneous disorder and present treatment only works for a limited number~     of patients. In order to identify new therapeutic targets, this study will longitudinally~     characterize the underlying pathologies in those with poor treatment response using~     complimentary brain imaging modalities.~   "
9533|NCT03442088|"~     This is an open label pilot study of the impact of treatment with standard dosing of Otezla~     for 16 weeks on AM-endotype psoriasis patients, identified by elevated (>150% of normal): 1.)~     Intermediate (CD14++CD16+) monocytes, or 2.) circulating monocyte doublets, or 3.)~     circulating monocyte-platelet aggregates (MPA).~      Approximately 25 psoriasis patients with the AM-endotype will be followed during treatment~     over 16 weeks with 4 monthly individual blood draws will be enrolled. 10 untreated healthy~     controls will also be enrolled and will provide two blood draws (baseline and 16 weeks).~     These are needed to maintain quality control of the normal levels of the biomarkers being~     tested. All treated psoriasis subjects will receive apremilast through Week 16~   "
9534|NCT03442075|"~     Define the best analgesic method between peri prostatic blockage, analgesic suppository, oral~     analgesic and topic anesthetic gel, during trans rectal prostate biopsy~   "
9535|NCT03442062|"~     HPV vaccination is at lower levels than the national goals. This study will evaluate the~     effectiveness of quality improvement strategies for increasing HPV vaccination coverage among~     adolescents in primary care clinics. The study will also evaluate the impact of delivering~     booster doses of the interventions one year later.~   "
9537|NCT03442036|"~     Following painful surgical procedures, postoperative analgesia is often provided with a~     single-injection peripheral nerve block. Hothe investigatorsver, even with the longest-acting~     FDA-approved local anesthetic currently available-bupivacaine-the block duration is measured~     in hours, while the surgical pain may persist for days. A continuous peripheral nerve block~     allows a prolonged block, consisting of a percutaneously-inserted catheter with its orifice~     adjacent to a target nerve/plexus through which local anesthetic may be administered. Two~     basic perineural catheter designs currently exist: (1) catheters that are inserted either~     through or over a straight hollow-bore needle; and, (2) catheters that are attached to the~     back of a hollow suture-shaped needle that pulls the catheter adjacent to the target nerve~     (suture-method design). To date, a comparison of the relative risks and benefits of these~     two designs have not been investigated. The investigators therefore propose a randomized,~     observer-masked, controlled, parallel-arm, clinical trial to compare these two catheter~     designs when used to provide post-surgical analgesia following foot and ankle surgery.~   "
9538|NCT03442023|"~     This study will assess the utility of different chlorhexidine mouthwash concentrations on ICU~     patients to decolonize their oral cavities from gram-negative bacteria, since this is a~     non-desirable condition that leads to higher mortality rates and longer hospitalization~     times. One group will receive the 0.12% chlorhexidine mouthwash and the other group will~     receive the 2% chlorhexidine mouthwash.~   "
9539|NCT03442010|"~     Emergency departments (EDs) are a crucial element of the health care systems at interface~     between hospital and communities. The goals of the ED are to make an initial diagnosis and~     deliver urgent and critical care 24 hour per day and 365 days a year. Also, many Adverse Drug~     Events (ADEs) are not identified by emergency physicians. ADEs are injuries resulting from a~     drug related medical intervention. Their detection, documentation and reporting are essential~     for adequate medical care and knowledge of risk/benefit profiles of medication throughout~     their lifecycle. However, a number of studies indicate that in clinical practice the~     under-reporting of ADEs is a pervasive and widespread problem. The main reasons for~     under-reporting were difficulty in determining the cause of the ADE, lack of time, poor~     integration of ADE-reporting systems and uncertainty about reporting procedures. Successful~     treatment of ADEs depends on the ability of physicians to attribute ADEs to a medication.~     Some studies have reported that pharmacists but also student pharmacists were one of the best~     health care providers to establish medication history. Consequently, the aims of our study~     were to assess prevalence and characteristics of ADEs identified in an emergency department~     and to identify factors associated with ADEs in ED patients.~      This prospective observational study is conducted at the ED of a tertiary care hospital~     (University hospital of Montpellier). This department supports 80 000 patients every years.~     Patient were not included if they were less than 18 years old, present acute psychological~     disturbance or they did not agree to participate at this study.~      For each patient included, a pharmaceutical team conducted: medication reconciliation process~     to establish medication history and a structured interviews to determine self-reported~     adherence and self-medication. ADEs were attributed to a medication by the treating senior~     emergency physician: directly during patient consultation or after being alerted by the~     pharmaceutical team.~   "
9540|NCT03441997|"~     The purpose of this study is to compare two different exercise programs to see if there are~     differences after exercise in fibromyalgia (FM) symptoms and responses from the immune~     system.~   "
9541|NCT03441984|"~     This is a 2-part, single-dose, open label, randomized 3-way cross-over study to compare BA of~     pediatric study drugs TRIUMEQ and (DTG/3TC) in healthy volunteers under fasted conditions.~     Study will be conducted in 2-parts. Each part 1 and part 2 will comprise of 3-treatment~     periods (TP) where Part 1, will assess BA, of pediatric TRIUMEQ dispersible tablets with an~     adult TRIUMEQ conventional tablet formulation and Part 2, will assess BA, of pediatric~     DTG/3TC dispersible tablets with adult DTG and 3TC conventional tablets formulation. Total~     duration of study is 9-weeks and will be conducted in approximately 36 subjects. The 2-parts,~     may be run in parallel as they are independent of each other. TRIUMEQ is a registered~     trademark of GlaxoSmithKline group of companies.~   "
9542|NCT03441958|"~     MM is a morbid disease associated with a poor outcome and while current therapies with new~     drugs have improved survival, MM still remains incurable in most patients. The only potential~     curative treatment remains allogeneic HSCT, as shown by our cohort of 92 NDMM patients who~     received a sibling tandem auto-allo Hematopoietic stem cell transplant (HSCT) with an~     estimated 10-year progression free survival (PFS) of 43%. However, the high incidences of~     toxicities including chronic graft-versus-host-disease (GVHD) (up to 79%) and disease~     progression (up to 49%) impair improvement in cure rate. Using umbilical cord blood (CB) as~     an alternative source of hematopoietic stem cells (HSC) could be superior biologically~     because of their increased proliferative capacity, greater number of progeny with longer~     telomeres and better anti-tumor efficacy in presence of positive residual disease. Moreover,~     using CB has been shown to decrease incidence of chronic GVHD. However, CBs have the~     disadvantage of having a limited HSC dose leading to prolonged cytopenia and higher risk of~     infections.~      In a first in-human trial using CB expanded with the ECT-001 (UM171) molecule~     (clinicaltrial.gov # NCT02668315), the median net expansion of HSC was 36 fold, which allows~     for the selection of better HLA matched CB regardless of their lower HSC dose. Moreover, the~     ECT-001 expanded CBs have a different cell composition than regular CBs, with more than 25%~     of dendritic cell precursors. This, combined to better HLA matched CBs, may reduce chronic~     GVHD incidence and improve immune reconstitution. To date, 22 patients received an ECT-001~     expanded CB and the procedure proved to be safe and feasible.~      In this new trial, the goal is to evaluate the safety and efficacy of ECT-001 expanded CB~     transplant in high risk MM patients.~   "
9543|NCT03441945|"~     The research continuously enrolled 100 patients undergone MCCG between May to December 2017~     as the intervention group with magnetic steering of capsule in the pylorus and duodenum, and~     randomly selected 100 patients before May 2017 from the database as the control group with~     passive movement of the capsule. The difference of the pyloric transit time (PTT) and~     duodenal papilla detection rate (DPDR) between the two groups were compared, and related~     factors were also investigated.~   "
9544|NCT03441932|"~     Specific objectives:~        -  Evaluation of morbidity and mortality associated with the severity of pharyngeal residue~          in patients admitted to Hotêl-Dieu de France university hospital for Stroke based on the~          The Yale pharyngeal residue scale~        -  Evaluation of the accuracy of screening protocol of Dysphagia at the Emergency~          Department in patients admitted for stoke based on the Emergency Department Dysphagia~          Screening Tool~   "
9626|NCT03440827|"~     The low-flow malformations include venous and lymphatic malformations. The malformation often~     affects the skin and can extend deep to the muscles and bone, as well as to deep organs.~     Children with low-flow vascular malformation and their family have difficulty living with~     their illness and have an impact on their life quality.~      In this context, the aim of the study is to develope life quality test for the children~     between 11 to 15 years old.~   "
9545|NCT03441919|"~     Hyperglycemia is a well-known cardiovascular risk factor. It has also been shown that~     episodes of hyperglycemia increase the risk for cardiovascular diseases despite return to~     normoglycemia, a phenomenon termed 'glycemic or metabolic memory'. The molecular mechanism~     underlying this phenomenon remains unclear.~      Cardiovascular events, such as myocardial infarction and stroke are caused by~     atherosclerosis, which is characterized by low grade inflammation of the vascular wall,~     including accumulation of innate immune cells such as monocytes and macrophages.~      The investigators hypothesize that chronic hyperglycemia shifts intracellular metabolism of~     innate immune cells towards glycolysis and changes the epigenetic state of (progenitors of)~     innate immune cells (monocytes and macrophages), which reprograms these cells towards a more~     aggressive, pro-atherogenic phenotype, thereby accelerating atherosclerosis.~      In this study, the investigators aim to test this hypothesis. This research will reveal~     whether the innate immune cells of patients with chronic hyperglycemia show a durable shift~     in intracellular metabolism and epigenetic changes and whether this associates with vascular~     inflammation.~   "
9546|NCT03441906|"~     Background:~      The prognosis of patients with rare cancers in general and sarcomas in particular suffers~     from delay in diagnosis. Routes to diagnosis for sarcoma need to be quicker and more~     streamlined, but have neither been studied in detail in larger numbers before, nor in a~     direct comparison between two countries with different health systems. Comprehensive~     assessment of diagnostic delays and its determinants, including demographic, clinical,~     psychosocial and health care system factors, is necessary to improve referral pathways and~     come to best practice and patient reported outcomes for sarcoma patients.~      Research questions to be answered:~      This study aims to quantify diagnostic delay (including patient, general practitioner and~     system delay) and evaluates routes to diagnosis and referral to sarcoma expert centres in the~     Netherlands and England; to comprehensively evaluate risk factors of diagnostic delay;~     determine the association between diagnostic delay and outcomes (health-related quality of~     life, quality-adjusted life years, patient satisfaction, TNM classification, time to~     local/distant relapse and overall survival); and to assess differences between both~     countries. This should lead to advices about faster referral where possible.~   "
9547|NCT03441893|"~     Ulcerative colitis (UC) is a chronic inflammatory disorder of the gastrointestinal tract of~     unknown etiology. UC is characterized by recurring episodes of inflammation limited to~     mucosal and submucosal layers of the colon. The object of the present study was to determine~     the prevalence of intestinal protozoa and helminthes in UC patients, and the role of this~     changes in aetiopathogenesis of diseases. Patients will be examined before and after therapy.~     Parasites and protozoa prevalence and intensity will be detected by triple~     coproscopy.Microbiological study will be conducted before therapy for detection pathogenic~     bacteria only from UC patients infected with B. hominis . If intestinal pathogenic bacteria~     are found, participants will be excluded from further investigation.~   "
9548|NCT03441867|"~     This multi-site study will examine patients with epilepsy (ES) following head injury [i.e.,~     posttraumatic epilepsy (PTE)] and posttraumatic psychogenic Non-epileptic seizures (PNES) and~     will compare them to patients with traumatic brain injury (TBI) who do not have seizures~     using functional neuroimaging.~   "
9549|NCT03441854|"~     Humidified oxygen therapy via high-flow nasal cannula (HFNC) is a recently available~     technique delivering heated and humidified high flow oxygen through simple nasal prongs. In~     immunocompetent patients HFNC can help generating low levels of Continuous Positive Airway~     Pressure (CPAP) due to the high flow of fresh gas, improving comfort and oxygenation, and it~     attenuates signs of respiratory distress compared with non-rebreathing oxygen face mask such~     as Venturi mask. Moreover, HFNC is considered to have several physiological advantages~     compared with other standard oxygen therapies, including the provision of positive~     end-expiratory pressure (PEEP), constant inspiratory oxygen fraction (FiO2), and good~     humidification. More importantly, it can reduce the anatomical dead space. For its advantages~     over conventional oxygen delivery system in patients undergoing abdominal surgery or~     Thoracoscopic Lobectomy, the investigators are currently and according to clinical practice~     using HFNC oxygen delivery in Liver transplantation after extubation, in our Post-Operative~     Intensive Care Unit (PICU).~      Due to recipients' generally poor preoperative clinical conditions, the extensive surgical~     field and long operating times, post-operative respiratory disorders are very common after~     liver transplantation and they significantly contribute to the related morbidity and~     mortality, both in the acute postoperative stage and in the long term. Several factors are~     involved in the onset of postoperative pulmonary complications (PPCs), and many preoperative~     and intraoperative variables have been associated with different degrees of severity of~     respiratory impairment after liver transplantation. In the early stages after~     transplantation, pulmonary complications may prolong intubation time and increase the risk of~     systemic infective complications. Prolonged mechanical ventilation due to refractory~     respiratory failure is an extremely morbid event, as this event is a marker of poor recipient~     recovery, predisposes a recipient to long term ventilator dependency and predicts further~     complications.~      In this matched control study, the investigators hypothesize that HFNC treatment might be~     superior to conventional oxygen therapy in terms of post-operative gas exchange and~     post-operative pulmonary complications for patients undergoing liver transplantation after~     extubation.~   "
9550|NCT03441841|"~     This trial evaluated the pharmacokinetic interaction between fixed doses of lidocaine (2.5%),~     prilocaine (2.5%) or the association of both (Nanorap®) in healthy volunteers. The drug~     safety and tolerability was also evaluated.~   "
9551|NCT03441828|"~     Comparison of the impact of a deep neuromuscular blockade (TOF count = 0 and posttetanic~     count [PTC] 1-2) and a moderate neuromuscular blockade (TOF count= 1 - 3) on intraoperative~     surgical conditions assessed by the surgeon as a 5 points scale (Optimal= 5 points/ Good= 4~     points / Adequate= 3 points / Poor = 2 points / Inadequate = 1 point) in patients undergoing~     laparosopy for benign gynecological pathologies.~   "
9552|NCT03441815|"~     A double-blind, randomized, placebo-controlled, Phase I clinical study of the safety and~     tolerability of increasing doses of XC8 after single and repeated oral administration in~     healthy volunteers. The volunteers received the study drug once, and then continued daily~     intake for 14 days after a 6-day break.~      The primary objective of the study was to evaluate the safety and tolerability profile for~     XC8 after single and multiple administration based on the frequency and severity of adverse~     events and changes in vital signs, laboratory results, electrocardiography and results of the~     physical examination.~      The secondary objective of the study was to assess pharmacokinetics of XC8.~   "
9565|NCT03441633|"~     Apixaban is a direct anticoagulant, which inhibits the factor Xa. Its clinical efficiency in~     prevention of stroke and systemic embolism in adult patients with NVAF (non/valvular atrial~     fibrillation) was demonstrated as well as has shown better safety profile compared with~     warfarin. A Drug Utilization study will evaluate whether this drug has been used in~     accordance with the approved indication and recommendations described in the summary of~     product characteristics (SmPC) and estimate possible misuse or overuse apixaban.~   "
9627|NCT03440814|"~     The purpose of this is study is to evaluate the effects of DCCR (diazoxide choline controlled~     release tablets) in children and adults with Prader-Willi syndrome.~   "
9556|NCT03441763|"~     Background: The foot is considered a sensitive structure of musculoskeletal system that bears~     significant loads of the body weight during walking. So, the evaluation of the body weights~     on planter pressure distribution during walking among adult obese subjects is very critical~     for foot dysfunctions.The aims:To evaluate the planter pressure distribution in normal ,over~     weight and obese adult during dynamic situation. Subjects and Methods: A one-hundred fifty~     normal adult (male and female) subjects will be recruited in this study. They will be divided~     into Group-I: includes 50 normal subjects Group-II: includes 50 of over weight~     subjects.group-III 50 obese adult subjects The all three groups will be detected according to~     the individual BMI. The details of the study will be explained to each participant and a~     consent form was signed by each subject.Each participant should be free from any~     musculoskeletal or locomotors disorders Conclusion: Results of this study can help physical~     therapists to understand the foot pressure distribution map for normal , over weight and~     obese and non-obese subjects to detect any foot abnormalities and detect any causes of foot~     dysfunctions.~   "
9557|NCT03441750|"~     A multicentred, randomized, open study to evaluate the efficacy of metformin in preventing~     Diabetes.~   "
9558|NCT03441737|"~     Although more than half of Canadian smokers in 2015 attempted to quit, with one-third~     attempting more than once, successful smoking cessation (quitting) remains a challenge.~     Relapse (return to smoking) has been attributed to failures in inhibitory control. Inhibitory~     control is the ability to suppress actions. Previous studies have identified that aerobic~     exercise improves inhibitory control and reduces the urge to smoke. This study will examine~     whether an acute bout of moderate intensity aerobic exercise (i.e. brisk walk on a treadmill)~     will improve inhibitory control, increase time to first cigarette smoked, and reduce urges to~     smoke during a brief period of abstinence. Inhibitory control will be assessed using the~     antisaccade task, which requires the participant to shift their gaze away from a visual~     target presented to them. Phase I will include assessments of smoking behaviours, physical~     activity levels, urges to smoke, and inhibitory control. Phase II will consist of a 12-hour~     smoking abstinence period conducted at home, followed by reassessment of urges to smoke and~     inhibitory control. Participants will then be randomized to either 20 minutes of aerobic~     exercise or sitting. Following the intervention, reassessment of urges to smoke, inhibitory~     control, and time to first cigarette smoked will be conducted.~   "
9559|NCT03441724|"~     The study aim is to evaluate the capability of mechanocardiography in detecting acute~     myocardial ischemia in patients suffering evolving ST-segment elevation infarction.~   "
9560|NCT03441711|"~     Preeclampsia: associated with poor placentation, incomplete uteroplacental spiral arteries~     remodeling. Result: ischemia, re-perfusion injury, oxidative stress.~      A low-grade systemic inflammatory response is more pronounced in preeclampsia. This results~     in an imbalance between maternal circulating pro-angiogenic (PlGF & VEGF) & anti-angiogenic~     factors (sFlt-1).~      PlGF & VEGF function as vasodilators & preserve structure & function of glomerular~     endothelium. sFlt-1 blocks these actions, resulting in hypertension, endothelial dysfunction~     & nephropathy.~      Various stressors, including hypoxia, villous crowding, angiotensin II, & oxidative stress~     are associated with preeclampsia & mediate secretion of soluble vascular growth factor 1~     (sVEGFR-1 or sFlt-1) by GADD45 (Growth Arrest and DNA Damage-45). GADD45 is one of a family~     of stress-induced genes sFlt-1 releases into maternal circulation. Excess sFlt-1 leads to~     endothelial dysfunction, hypertension & proteinuria.~      Exogenously administered sFlt-1 results in syndrome of nephrotic range proteinuria,~     hypertension, and glomerular endotheliosis in animal models.~      Women with preeclampsia tend to have higher sFlt-1 & lower PlGF, resulting in an increased~     ratio (sFlt-1:PlGF). The difference is greater in women who develop early-onset preeclampsia~     (before 34 wks gestation).~      Verlohren, et al., showed an increased sFlt-1/PlGF ratio in patients with preeclampsia as~     compared to controls & patients with chronic/gestational hypertension.~      Other work has examined the longitudinal changes in the individual values of sFlt-1 & PlGF~     over the course of the pregnancy, as well as the ratio.~      Given the low prevalence of preeclampsia in the population, the positive predictive value~     remained low, however the negative predictive value approached 97% late in gestation. This~     suggests that the utility of the sFlt-1/PlGF may be in its ability to rule out preeclampsia.~      More recently the PROGNOSIS study was designed to investigate the value of the sFlt-1/PlGF~     ratio for the prediction of the presence or absence of preeclampsia in the short term & found~     that a cutoff point of 38 for the sFlt-1/PlGF ratio is useful for predicting the short-term~     absence of preeclampsia in women with suspected disease (Negative predictive value 99.3% for~     ruling out preeclampsia within 1 week).~      Hypothesis: In women with chronic hypertension, the sFlt-1/PlGF ratio will better predict the~     development of superimposed preeclampsia than clinical criteria alone.~   "
9561|NCT03441698|"~     Background: The communication between a patient and clinician may have significant effects on~     treatment outcomes and one likely mediator of the communication-related treatment effects is~     patient expectations, as demonstrated by placebo studies in various clinical domains. To~     investigate the link between patient-clinician interactions and patient expectancy in a~     clinical setting, acupuncture is suggested an effective method, as acupuncture is a procedure~     with known non-specific treatment components. As a scene for investigating the importance of~     expectations on treatment outcomes, the investigators used acupuncture for relaxation~     effects. It is commonly reported that participants experience a sense of relaxation during~     acupuncture treatment, yet, it is not known if the effects are related to the specific~     effects of needling or non-specific effects associated with the treatment procedure.~      Aim: To investigate if communication type (positive or neutral) about the expected treatment~     outcome affected i) participants' expectations, ii) short-term relaxation effects in response~     to genuine or sham acupuncture or to rest, and to investigate if treatment expectations were~     related to outcome.~      Procedure: Volunteers, i.e. Swedish individuals in general, not part of any specific patient~     group, are given written and oral study information and are screened for study criteria. The~     volunteers giving informed consent are randomized to one treatment session a´30 minutes with~     a) genuine acupuncture or b) sham acupuncture (telescopic non-penetrating needles).~      They are compared to a non-randomized reference group that receive no acupuncture, just 30~     minutes of rest.~      Within the three groups, participants are randomized to 1) positive communication or 2)~     neutral communication from therapists, regarding expected treatment effects.~      Outcome measures: Visual analogue scales (VAS) (0-100 millimeter) measured treatment~     expectations and relaxation, at baseline two hours before the treatment session, pre~     treatment (directly before the treatment session) and post treatment (directly after the~     treatment session). Heart rate, blood pressure, and salivary cortisol are measured pre and~     post treatment. Primary endpoint is change in relaxation pre to post treatment.~   "
9562|NCT03441685|"~     This study is designed to evaluate whether children with Down syndrome and children with~     typical development exhibit different levels of accuracy demonstrating novel verbs taught~     under three conditions: semantic cues (perform action), syntactic cues (sentence frame), and~     combined (syntactic and semantic cues). The participants complete an eligibility evaluation~     and then one verb learning session (approximately 60 minutes in length). During that verb~     learning session they are taught sets of words under each condition (i.e., within-subjects~     design) and then asked to identify and label those target words immediately after~     instruction.~   "
9563|NCT03441672|"~     Significant barriers exist for effectively informing women about prenatal screening in the~     clinical setting. This project developed and evaluated the efficacy of a game decision aid~     among pregnant women about prenatal screening in a randomized controlled study.~   "
9564|NCT03441659|"~     The study is intended to include all patients who will undergo surgical reconstruction of the~     anterior cruciate ligament (ACL). The patients will be monitored and evaluated preoperatively~     and also at 6 months and 1, 2 and 5 years after the intervention through a clinical visit or~     telephone interview. Such assessments will include the administration of questionnaires to~     determine the patient's functional symptoms and the objective examination of the knee during~     a medical examination to quantify its stability.~   "
9572|NCT03441542|"~     This study seeks to implement and evaluate a data-driven case navigation system for hepatitis~     C virus (HCV) treatment among persons who are either actively injecting drugs or who are~     receiving opioid substitution therapy (OST). The study will use data from a previously~     developed patient registry system to identify patients for study recruitment, and use monthly~     updates of registry data to organize and direct patient navigation services for those~     individuals assigned to the treatment group. Patients assigned to the control group will also~     be eligible to receive HCV treatment, but will otherwise receive usual care.~      This study has a parallel, randomized unblinded, case/control design in which eligible~     patients are assigned at baseline to either a registry-directed patient navigation system~     (case) or to usual care (control), characterized in terms of demographic and sub-population~     variables, and then compared after 12 months on two categories of outcomes; (1) attainment of~     care cascade milestones; and (2) treatment initiation, adherence, and virologic response. The~     study is designed and powered to answer two primary hypotheses (H1 & H2):~        -  H1: As compared to those randomized to usual care (control), those randomized to the~          registry directed patient navigation arm (case) will be more likely to complete all~          pretreatment HCV care milestones as defined by a higher proportion completing all four~          pre-treatment care cascade outcomes.~        -  H2: As compared to the control group, a significantly higher proportion of those~          randomized to the case group will achieve a sustained viral response.~   "
9573|NCT03441529|"~     The main purpose of this study is to evaluate the effect of intravenous (IV) infusions of~     piperacillin/tazobactam on the pharmacokinetics (PK) of JNJ-63549109 after a single oral dose~     of lumicitabine in healthy adult participants.~   "
9574|NCT03441516|"~     This study will evaluate the performance of Alzheimer's Disease Assessment Scale-cognitive~     subscale (ADAS-cog) in patients with Alzheimer's disease (AD).~   "
9575|NCT03441503|"~     The goal of this study is to identify effective ways to assess the patient and family~     experience. Specifically, the study will examine automated administration of the Child~     Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey on the day~     of discharge through an electronic interactive patient care system. The will be a multisite~     study that will take place at Boston Children's Hospital (BCH) as well as at several other~     hospitals across the United States.~   "
9576|NCT03441490|"~     The purpose of this study is to evaluate the effects of learning support and chat on~     treatment outcome in internet-administrated cognitive behaviour therapy (ICBT) for~     adolescents with anxiety.~   "
9577|NCT03441464|"~     The primary objective of this feasibility study is to determine if administration of LUM015~     will result in positive fluorescence of tumor tissue from ex vivo specimen imaging with the~     LUM Imaging device from patients undergoing radical prostatectomy for prostate cancer. Both~     normal tissue and tumor tissue will be imaged and analyzed. The LUM Imaging System is a~     portable combination product consisting of an imaging device and an imaging agent (LUM015).~      Patients with an established diagnosis of prostate cancer and who are eligible for radical~     prostatectomy will be screened. Eligible patients will be enrolled and on the day of their~     planned surgery, LUM015 will be administered 2-6 hours prior to surgery. Patients will~     undergo radical prostatectomy 2-6 hours after LUM015 administration. All surgical specimens~     will be imaged with the LUM imaging device and have routine diagnostic assessment. Patients~     will be monitored for adverse events from time of injection through the first standard of~     care post-surgical follow-up visit.~   "
9578|NCT03441451|"~     Persons with obesity are more likely to suffer from many other serious health conditions and~     are more likely to die young. Lifestyle interventions have not been found to be an effective~     long-term solution for treating obesity. When usual weight loss measures are not successful,~     bariatric, or 'weight loss,' surgery may be considered. Bariatric surgery is performed to~     help people with obesity achieve weight loss which they can maintain. Weight loss following~     bariatric surgery leads to improvement in health and well-being, and patients have been shown~     to live longer. It is invasive surgery which has surgical risks and potential side effects,~     including death. Since people are having this surgery to improve their health, it is~     important that the surgery is performed with a minimum of side effects, otherwise it cannot~     be justified. Information is collected about the surgery, any complications after the~     surgery, weight at various time points, and if the patient has diabetes and how it is is~     treated. Patient details are needed to be able to identify patients on the registry and track~     their progress through data linkages. Participants have information about their bariatric~     surgery provided to the registry by their surgeon or hospital. They may also be contacted~     directly by the registry staff to see if they had any complications and if the surgery had~     any effect on their health (if they have diabetes), weight, and well-being. The Registry will~     hold their identifiable information as it aims to follow each patient for ten years after~     their first bariatric operation. By systematically collecting information on every procedure~     performed in Australia and New Zealand, the registry will help to identify when surgeons,~     hospitals or procedures not performing to the expected standard. A Bariatric Surgery Registry~     should also be able to demonstrate how effectively bariatric surgery results in weight loss~     and improved health (using diabetes as a marker of health) across the two countries.~   "
9579|NCT03441438|"~     The purpose of this study is to determine what type of reactions in the body may be~     responsible for the respiratory symptoms that occur when patients with Aspirin Exacerbated~     Respiratory Disease (AERD) drink alcoholic beverages. These reactions are most often seen~     with red wine.~   "
9580|NCT03441425|"~     Some educational researchers deliberately induce stress upon learners to in order to enhance~     retention; this practice is controversial and its utility must be weighed against the~     negative emotional effects it may have on participants. In this study we investigate the~     effect of the unexpected death of a simulation mannequin on the retention of non-technical~     and technical crisis resource management skills and consider the emotional impact of this~     acute stressor.~   "
9581|NCT03441412|"~     The study is an experimental observational study in ten healthy volunteers. Based on an in~     vitro study, it is hypothesize that a low dose epinephrine infusion will improve platelet~     function in healthy volunteers who have received ticagrelor. Volunteers fulfilling all of the~     inclusion and none of the exclusion criteria will be included. Enrollment will be continued~     until the required sample size is achieved (10 subjects).~      Once informed consent is obtained, screening data will be collected to determine each~     subject's eligibility for study participation. The total expected duration of subject~     participation is 18 days, from screening visit to end of follow-up. The active participation~     is 8h (study procedure 4 hours, observation period 4 hours).~   "
9582|NCT03441399|"~     The investigators will test using financial incentives by leveraging decision-making biases~     to improve adherence to antidepressants among adults newly prescribed antidepressants. This~     study will compare the effects of usual care, increasing financial incentives, and decreasing~     financial incentives on daily antidepressant medication adherence and depression symptom~     control of non-elderly adults with Major Depressive Disorder.~   "
9583|NCT03441386|"~     Cognitive function and psychological well-being are two variables related to academic~     performance. Several studies have shown that these variables are sensitive to acute physical~     exercise, but it is not known which doses of exercise are the most adaptive. To explore this~     issue, a quasi-experimental study was conducted with 35 adolescents from three physical~     education classes. Participants performed three sessions of physical education with different~     doses of exercise: no exercise, light/moderate exercise, and moderate/vigorous exercise,~     controlling intensities with accelerometers. All subjects completed the Stroop test (to~     measure cognitive inhibition) and well-being questionnaires of subjective vitality, positive~     affect and negative affect before and after each session.~   "
9584|NCT03441373|"~     A multicenter double-blind, randomized, placebo-controlled, parallel-group comparative Phase~     II / III clinical study to assess safety, tolerability, efficacy and optimal dose ranging of~     XC8 vs. placebo in patients with uncomplicated influenza or other ARVI during a 5-day~     treatment.~      The primary objective of the study was to demonstrate the difference in time before the onset~     of a sustained improvement in clinical symptoms according to the Severity Rating Scale for~     ARVI, and to determine the optimal dose of XC8 in the treatment of influenza and other ARVI.~   "
9585|NCT03441360|"~     This study will be conducted as an assessment of the safety and preliminary activity of~     eribulin mesylate in pediatric participants with relapsed/refractory rhabdomyosarcoma (RMS),~     non-rhabdomyosarcoma soft tissue sarcoma (NRSTS), or Ewing sarcoma (EWS) to determine whether~     each cohort warrants further investigation.~   "
9586|NCT03441347|"~     This study evaluates the effect of a specific, multidisciplinary and personalized~     rehabilitation program compared to usual care, on motor control and functional disability in~     patients with neuralgic amyotrophy.~      Half of the participants will start with the 17-week specific rehabilitation program while~     the other half will first continue their usual care for 17 weeks, after which they will also~     receive the 17-week specific rehabilitation program.~   "
9587|NCT03441334|"~     The study will enroll 5 individuals post-stroke to examine the feasibility and efficacy of a~     high frequency repetitive transcranial magnetic stimulation (rTMS) combined with body weight~     supported treadmill training.~   "
9588|NCT03441321|"~     This randomized clinical trial studies how well social-media intervention works in reducing~     indoor tanning in high-risk indoor tanners. Social-media intervention delivered via Facebook~     may help to promote healthy behaviors, positive body image, and to understand young women's~     perception of a social media campaign.~   "
9589|NCT03441308|"~     The concept Dare to be satisfied with food is an educational method of group treatment~     based on regular meals and food based on Nordic nutrition recommendations. The method has~     been developed by a district nurse at the city of Ljungby, Sweden and has shown permanent~     weight loss in a limited number of persons who tested the method. It is important to test the~     method scientifically and in the long term for possible implementation in routine activities~     in the healthcare sector. Adults with overweight and obesity (BMI 27-45) will be recruited to~     the study by announcing in newspapers in the counties of Kronoberg and Kalmar and then~     randomized to intervention group and control group, where the control group receives dietary~     advice according to the Swedish National Food Agency's guidelines for overweight and obesity~     (including brochures).~   "
9590|NCT03441295|"~     Single-blind, multi-centre, prospective, randomized controlled trial comparing Ligamys~     Anterior Cruciate Ligament (ACL) repair, Internal Bracing ACL repair and conventional ACL~     reconstruction for relative clinical efficacy and economic benefit.~      Patients with a primary proximal acute ACL rupture will be included in either study 1 (0-4~     weeks post rupture) or study 2 (5-12 weeks post rupture) of the LIBRE study.~   "
9591|NCT03441282|"~     The concept of precision medicine - taking individual variability into account when planning~     preventions and interventions - is not new but is quickly gaining attention in this age of~     powerful methodology of patient characterization and development of tools to analyze large~     sets of data. Oncology is the most obvious field in which this information has been readily~     applied. Increasing focus, nationally and internationally, on developing broad databases of~     patient genetic information and research efforts evaluating those data will, hopefully, lead~     to the development and application of evidence-based data enhancing the practice of all~     fields of medicine. It has yet to become obvious how this information can best be applied to~     the field of anesthesiology. Most genomics work in anesthesia has been focused in the area of~     pain medicine. There is a known genetic influence on the potency of opioid-induced analgesia,~     however; a genetic component of opioid-induced respiratory depression has yet to be~     thoroughly evaluated. Respiratory depression plays a role in clinical care - from procedures~     requiring sedation with monitored anesthesia care to treating post-opertative pain and~     chronic pain - but perhaps its largest current role in the public arena is the unfortunate~     deaths caused by side effects due to drug overdose.~      Personalized medicine remains on the horizon for the field of anesthesia, but, as genetic~     testing becomes more affordable and mainstream in clinical practice, the potential~     applications are broad. Most readily would be its incorporation into development of patient~     specific pain regimens. Respiratory depression is a potentially lethal side effect of opioid~     therapy. In light of the opioid epidemic and CDC-scrutiny of opioid use, determining genetic~     profiles susceptible to respiratory depression could prove useful in further tailoring the~     treatment of pain both in the perioperative setting and in the chronic pain management~     setting.~   "
9592|NCT03441269|"~     Ibuprofen is one of the most widely used non-steroidal anti-inflammatory drug (NSAID) for~     management of mild -to moderate pain in the ED (acute musculo-skeletal pain, headache, dental~     pain). Ibuprofen as a representative of NSAID's as a class follows the analgesic ceiling~     concept that postulates that there is a dose of a drug beyond which any further dosage~     increase results in no additional analgesic effect. Despite this fact, Ibuprofen may commonly~     be used at doses above its analgesic ceiling, although this may not offer an incremental~     analgesic advantage and potentially adds risk of harm. The analgesic ceiling dose for~     ibuprofen is only 200-400mg/dose, and about 1200 mg/day. Thus, we hypothesize that~     administration of Ibuprofen in a dose of 400 mg in the ED is as effective in treating~     mild-to-moderate acute pain in patients presenting to the ED as 600 mg and 800 mg~   "
9593|NCT03441256|"~     Possover pioneered a minimally invasive and fully reversible laparoscopic technique,~     laparoscopic implantation of neuroprosthesis (LION), for precise placement of an implantable~     pulse generator and one to four leads for stimulating nerves of the lumbosacral plexus.~      Unexpectedly, Possover in 2014 made the clinical observation that four patients with complete~     and incomplete chronic traumatic spinal cord injury regained significant motor and sensory~     function following the LION procedure for bladder and bowel dysfunction.~      The primary objective of this randomized clinical trial is to investigate whether the LION~     procedure and the subsequent neurostimulation in individuals with chronic traumatic~     thoracolumbar spinal cord injury with spastic paraplegia is associated with increased walking~     capacity.~   "
9594|NCT03441243|"~     Prospective, non-interventional, monocentric, case-control study~   "
9597|NCT03441204|"~     Multicenter, phase IV, registry-based, randomized controlled trial. Patients starting~     long-term oxygen therapy (LTOT) are randomized between LTOT prescribed 24 h/day or 15 h/day~     using the Swedish Register for Respiratory Failure (Swedevox). Clinical follow-up and~     concurrent treatments are according to routine clinical practice. The main endpoints of~     mortality, hospitalizations, and incident disease are assessed using Swedish registry data,~     with expected complete follow-up. Patient-reported outcomes are assessed using a posted~     questionnaire at 3 and 12 months. The study is managed by the Uppsala Clinical Research~     Centre (UCR).~   "
9598|NCT03441191|"~     Background and Purpose: The purpose of the study is to test the efficacy of an audio-visual~     stimulation program for sleep promotion in adults with chronic pain. The hypothesis is that~     hyper-arousal plays an important role in insomnia. Brainwave entrainment from 8 to 1 Hz~     reduces arousal, and thereby improves sleep. Improved sleep may change how people perceive~     pain.~      Methods: Using a double-blind, randomized controlled trial design, we plan to enroll 30~     adults (21-65 years old) experiencing both nonmalignant pain and insomnia. Exclusion criteria~     include: seizure disorder, sleep disorder, and night shift workers. After a one-week baseline~     measure, participants will be randomized to intervention or placebo group. Participants in~     both groups will be asked to self-administer the audio-visual stimulation program every night~     at bedtime for one month. Upon completion, post intervention measures will be collected.~   "
9599|NCT03441178|"~     This prospective, single-arm, multi-center, evaluation will collect clinical data in a~     post-market setting. The three types of procedures studied will be colectomy, gynecological,~     and thoracic. Investigators will perform each procedure using the device in compliance with~     their standard surgical approach and the ENSEAL X1 instructions for use.~   "
9600|NCT03441165|"~     Intraoperative knee laxity evaluation of patiente undergoing ACL reconstruction, ACL~     revision, MAT~   "
9601|NCT03441152|"~     Objectives: 1) To examine whether the real transcranial direct current stimulation (tDCS)~     group would perform better in the cognitive training (CT) intervention than the sham tDCS~     group and the CT group; 2) To determine if, as a consequence of the stimulation generated by~     the use of tDCS, there would be a transfer effect to other cognitive domains and to cognitive~     tasks in activities of daily living; 3) To investigate the time and spatial responses of tDCS~     on the brain cortex during and after tDCS application.~      Hypothesis to be tested: By applying anodal tDCS with the combination of a CT delivered via~     the use of tablet PCs in older adults at risk of MCI, it will enhance their cognitive task~     performance in CT and subsequently generalize to other cognitive domains as well, involving a~     transferability to cognitive tasks in activities of daily living.~      Design and subjects: A multi-centered single-blinded randomized controlled trial (RCT) with~     three groups (CT alone/Sham tDCS with the combination of a CT/ Real tDCS coupling with CT)~     The participants who will take part of this study will be older adults at risk of MCI Study~     instruments: tDCS, Ipad, Neuron Up CT Apps, EEG. Interventions: The intervention will last~     for 9 sessions (3 sessions per week for 3 weeks). Sham tDCS and real tDCS, will be combined~     with the same CT which is used in the CT group. During the experimental intervention, anodal~     tDCS will be placed on left dorsolateral prefrontal cortex (DLPFC) and cathodal tDCS on the~     contralateral deltoid muscle with the combination of a CT. During the experimental~     intervention, anodal tDCS will be placed on left dorsolateral prefrontal cortex (DLPFC) and~     cathodal tDCS on the contralateral deltoid muscle with the combination of a CT.~      Main outcome measures: Cognitive assessments, CT performance, EEG. In addition, delta and~     theta frequency suppression and alpha increment power under the anode electrode will be~     observed.~   "
9602|NCT03441139|"~     The primary objective of this trial is to compare the efficacy of 2 analgesic strategies,~     based on percutaneous cryotherapy plus medical supportive care versus medical supportive care~     alone in the treatment of cancer patients with painful musculoskeletal metastasis.~   "
9603|NCT03441126|"~     This study will test the hypothesis that reliable implementation of an evidence-based~     clinical practice guideline for evaluation of patients with signs and symptoms of sepsis will~     decrease antibiotic use in pediatric intensive care units (PICUs).~   "
9604|NCT03441113|"~     The primary objective of this study is to provide extended access of momelotinib (MMB) in~     participants with primary myelofibrosis (PMF) or post-polycythemia vera or post-essential~     thrombocythemia myelofibrosis (Post-PV/ET MF) enrolled in Gilead sponsored studies~     GS-US-352-0101 (NCT01969838), GS-352-1214 (NCT02101268), GS-US-352-1154 (NCT02124746), who~     are currently receiving treatment with MMB (available as 100 mg, 150 mg and 200 mg tablets)~     and have not experienced progression of disease.~   "
9605|NCT03441100|"~     The study purpose is to establish the safety and tolerability of IMA202 product in patients~     with certain solid tumors.~   "
9606|NCT03441087|"~     Although hysteroscopy (HS) and transvaginal ultrasonography (TVSG) are methods in the~     diagnosis of AUB, there is some suspicion about their efficacy. The aim of this study was to~     determine the efficacy and safety of HS and TVSG on diagnosing abnormal uterine bleeding(AUB)~     .216 women admitted to the investigators clinic (Sisli Ethal Training and Research Hospital,~     Obstetrics and Gynecology Department Obstetrics Service ) between 21-51 years of age. These~     patients were divided into two groups; menopause (71women) and pre-menopause (145 women). HS~     and endometrial sampling were performed both groups after TVSG.The success of these methods~     was assessed by kappa analysis~   "
9607|NCT03441074|"~     To study the correlation of POCD with olfactory function. To explore whether enhanced~     olfactory stimuli can reduce the risk of POCD as a preventive strategy.~   "
9608|NCT03441061|"~     The goal of this clinical research study is to learn how well low-dose inotuzumab ozogamicin~     may help to control acute lymphocytic leukemia (ALL). The safety of the study drug will also~     be studied.~      This is an investigational study. Inotuzumab ozogamicin is FDA approved and commercially~     available for the treatment of ALL.~      The study doctor can explain how the study drug is designed to work.~      Up to 40 participants will be enrolled in this study. All will take part at MD Anderson.~   "
9609|NCT03441048|"~     This is a prospective, single-center phase I clinical study aimed at determining the~     maximum-tolerated dose and safety of Lintuzumab-Ac225 in combination with CLAG-M chemotherapy~     in the management of relapsed/refractory acute myeloid leukemia. This study uses a 3+3 design~     to estimate the maximum-tolerated dose (MTD).~   "
9610|NCT03441035|"~     This clinical observational cohort study assess the loss of albumin from blood circulation~     during and after liver transplantation by mass balance of albumin. The overall assumption of~     this method is that if albumin is more diluted than hemoglobin, it must have left the plasma,~     presumably into the interstitial space. Predictors of albumin leakage will be assessed,~     including biomarkers of inflammation and of endothelial damage and dysfunction. The sub~     cohorts children and patients with complications, defined as prolonged postoperative~     treatment in the intensive care unit, respectively, will be focused in separate publications.~   "
9611|NCT03441022|"~     The purpose of this study is to determine whether a wristband that detects your pulse can~     detect your heart rate and rhythm similar to electrocardiograms (ECG).~   "
9612|NCT03441009|"~     Adult patients suffering from acquired brain damage run the risk of developing PSH. This~     group of patients is admitted to our unit, the Neurointensive Stepdown Unit, at Silkeborg~     Regional Hospital for intensive care and early neurorehabilitation. After weaning from~     intensive carethey are transferred to Hammel NeuroCentre.~      Aim is to assess whether HRV-derived variables in the frequency domain mirror therapeutic~     and/or nursing and/or pharmacologic interventions. To the extent clinically available BRS and~     metabolism are included in the assessment.~   "
9613|NCT03440996|"~     The purpose of the study is to determine if Clinpro™ 5000, Clinpro™ Tooth Crème, or MI-Paste~     Plus has an effect on the formation and resolution of white spot lesions for patients~     undergoing orthodontic treatment. This study will include 90 patients in the UAB Orthodontic~     Clinic.~   "
9614|NCT03440983|"~     Using MRI, many technical parameters can be changed to optimize the diagnostic quality of the~     examination. The study is interventionnel because healthy volunteers are not supposed to have~     an MRI exam.~      The primary objective of this study is to optimize the imaging protocols and to validate the~     choice of the technical parameters in healthy volunteers.~      The quality of the images, cartographies or spectres will be compared to standard~     acquisitions. This evaluation will be based on qualitative visual criteria assessed by expert~     radiologists or on quantitative criteria assessed by data processing tools.~   "
9615|NCT03440970|"~     This study is designed to investigate the quantitative effects of sodium-free chloride~     supplementation on electrolyte balance, volume status, and sodium avidity in stable heart~     failure patients in a highly controlled environment.~   "
9616|NCT03440957|"~     Staying confined in the bed is frequent at the end of life. The cancer patients can also~     experiment this situation, and consequences are painful, with pain increasing with the time.~     This pain are related to the joints stiffing , muscles mass decreasing, and tendons~     retractions . The non pharmacological approach associated with the conventional treatments~     can be interesting to assess in this frails patients.~   "
9617|NCT03440944|"~     Obtaining intravenous access (IVA) is the most common procedure performed in the emergency~     department (ED). Placement of IVA allows for blood work and delivery of intravenous fluids~     and medications. The implementation of ultrasound guided peripheral IVs (UGPIV) have allowed~     for ultrasound to be used to place an IV into patients with difficult vein access (DVA). An~     alternative device to place is a midline catheter (MC). The use of MCs against UGPIV has not~     been compared in a randomized study. Aim 1: To determine if UGPIVs have a higher failure rate~     than midline catheters within 72 hours of placement. Aim 2: To collect information to perform~     a direct cost analysis of UGPIV against that of the midline catheter. Aim 3: Assess patient~     satisfaction.~   "
9618|NCT03440931|"~     This prospective study will primarily aim to determine what monitoring is required of ovarian~     cysts when they are diagnosed in pregnancy, as well as what intervention, if any, is~     necessary. It also aims to identify the prevalence of ovarian cysts in pregnancy and the~     nature of these cysts, as well as their natural history throughout pregnancy.~   "
9619|NCT03440918|"~     The timely use of antibiotics can reduce morbidity and mortality associated with bacterial~     infections, particularly in the intensive care unit setting (ICU). Long courses of~     antibiotics, however, are associated with the emergence of multi-drug resistant organisms and~     antibiotic-associated adverse events, such as C. difficile infections. Thus, antibiotic~     de-escalation is an important goal of antimicrobial stewardship programs.~      Procalcitonin (PCT) has been investigated as a biomarker for critically ill adult patients~     with bacterial infection, particularly pneumonia and sepsis. The proposed project will~     evaluate whether a PCT testing and treatment algorithm, implemented through daily~     antimicrobial stewardship audit and feedback, can promote early and safe antibiotic~     de-escalation in the pediatric ICU.~   "
9620|NCT03440905|"~     The purpose of this study is to characterize the symptoms of Zellweger Spectrum Disorder~     (ZSD) and related peroxisome disorders, and to assess the quality of life of family~     caregivers (parents, stepparents, legal guardians) of patients diagnosed with ZSD or a~     related peroxisome disorder. All family caregivers of patients enrolled in the Rare Diseases~     Clinical Research Network (RDCRN) Contact Registry who are diagnosed with ZSD or a related~     peroxisome disorder will be invited via email to participate in this study.~   "
9621|NCT03440892|"~     To validate the utility of survivin as a biomarker of pharmacological response to therapeutic~     intervention in rheumatoid arthritis patients.~   "
9622|NCT03440879|"~     Prostate cancer (PCa) patients receiving androgen deprivation therapy (ADT) (e.g., Zoladex),~     experience troublesome side effects during and after treatment (e.g., loss of lean body mass~     (LBM) and increased fat mass). Although the negative effects of ADT on muscle mass are well~     documented, the cellular effects of ADT on muscle tissue are still largely unknown, and~     studies investigating the mechanisms are highly warranted. Furthermore, understanding the~     cellular mechanisms through which ADT negatively influences muscle mass and glucose~     metabolism is important so that appropriate measures can be taken to counteract muscle~     wasting and comorbidities during ADT. Thus, PCa patients on ADT (Zoladex), along with non-ADT~     treated PCa patients serving as controls, will be invited to participate in this study, that~     aims to investigate the influence of ADT on the basal muscle protein turnover, as well as the~     responses to strength training. Secondary aims are to investigate between-group differences~     in blood glucose and insulin responses following a meal).~   "
9623|NCT03440866|"~     Medical termination of pregnancy is a common and safe alternative to surgical termination of~     pregnancy(8). The current protocol in the investigators unit includes oral administration of~     Mifepristone 600 mg and oral Misoprostol 400 mcg in a time interval of 48 hours. There is~     little data to compare the efficacy of concomitant administration of both drugs and different~     time intervals.~      This study evaluates the success rate and side effects of medical termination of pregnancy~     while both drugs are administrated concomitantly in comparison to interval of 48 hours~     between the drugs.~   "
9624|NCT03440853|"~     This study evaluates a collaborative care intervention in reducing depression, fatigue and~     pain symptoms and improving health related quality of life in hemodialysis patients. Half of~     participants will receive the collaborative care intervention, while the other half will~     receive technology delivered health education information.~   "
17098|NCT03343145|"~     A study to compare the efficacy, safety and immunogenicity of Leucostim® to those of~     Neupogen® in patients with breast cancer intended to be treated with TAC regimen as a~     myelosuppressive chemotherapy.~   "
9628|NCT03440801|"~     This study aims to compare the acute thrombogenecity and frequency of neoatherosclerotic~     lesions and other aspects of long term arterial healing such as the frequency of malapposed~     and uncovered stent struts at 3 years among patients treated with either a biodegradable~     polymer everolimus-eluting stent (Synergy) or a durable polymer everolimus-eluting stent~     (Xience Alpine) for STEMI.~   "
9629|NCT03440788|"~     The goal of this is study is focusing on assessment of patient-reported outcomes in terms of~     quality of life (QoL) and symptom profile as well on evaluation of clinical efficacy and~     safety of BV in patients with refractory/resistant HL in a real-world setting.~   "
9630|NCT03440775|"~     The proposed research will use a double-blind randomized controlled design to pilot test a~     model for how stories shared by a panel of HCT survivors impact the psychosocial well-being~     of the digital stories (DS) intervention condition of 55 patients who recently underwent HCT~     and their respective caregivers compared with 55 people in an information control (IC)~     condition and their caregivers (total 220 participants; N=110 per condition). Participants,~     recruited from the Mayo Clinic Arizona Cancer Center, will be randomly assigned to one of two~     conditions: the DS intervention or the IC video condition. Participants will questionnaires~     at baseline (T1), after the 4-week intervention (T2), and 3 months (100 days) later (T3).~   "
9631|NCT03440762|"~     The purpose of this study is to evaluate the outcomes of a community placed atrial~     fibrillation (AF) screening and education program~   "
9632|NCT03440749|"~     Cerebral palsy (CP) affects the motor function but also the cognitive function of the child.~     Physical activity brings motor and cognitive benefits and appears as an important aspect of~     the therapy that is offered to them.~      The child is seating in front of a computer, seating comfortably on a chair during 1 hour.~     The experimental task consists in learning a sequence of taps on Serial reaction time task~     type buzzers (SRTT) in which the child must press a buzzer corresponding to one of the 4~     squares that on the screen. The sequence corresponds to 10 steps in a particular order.~   "
9633|NCT03440736|"~     Around 40% of moderate to severe psoriasis patients are affected by concomitant metabolic~     syndrome, making it one of the clinically most relevant comorbidities. Psoriasis as well as~     the metabolic syndrome are both characterized by a state of low-grade systemic inflammation~     (e.g. in the skin, joints, adipose tissue, liver or vascular endothelium). This shared~     pathophysiology makes systemic inflammation an attractive target for the treatment of both~     diseases. Secukinumab as well as lifestyle intervention are able to reduce systemic~     inflammation.~      This trial is designed to answer the question whether the combination of Secukinumab with~     lifestyle intervention can primarily improve skin symptoms and secondly cardiometabolic~     status more than Secukinumab alone in psoriasis patients with concomitant metabolic syndrome~     by targeting the shared pathophysiology behind both diseases, which is systemic inflammation.~   "
9634|NCT03440723|"~     Trial to compare the interexaminer agreement between two cervical dilation examinations~     conducted by Labor and Delivery physicians when using standard methods versus DilaCheck~     device.~   "
9635|NCT03440710|"~     Currently, surgical treatment of patients with chronic otitis media is one of the most~     important treatment methods. However, the current results show that some patients with~     eustachian tube dysfunction can't reconstruct the gas-containing structure of the middle ear~     after operation.~      This is a randomized controlled trial that aims to evaluate the therapeutic effect of balloon~     eustachian tuboplasty (BET) for the treatment in chronic otitis media (COM) with eustachian~     tube dysfunction (ETD). This future study will aim to address the question: Does BET gain~     better recovery of auditory function and lower recurrence rate in chronic otitis media with~     eustachian tube dysfunction?~   "
9636|NCT03440697|"~     The main purpose of this study is to define the complex genetic and pathogenic basis of~     thoracic aortic aneurysm (TAA) and other forms of aortopathy and/or aortic valve disease by~     identifying novel disease-causing genes and by identifying important genetic modifiers for~     aortic and aortic valve disease severity.~   "
9637|NCT03440684|"~     The core region is prescribed as a box which is formed from abdominal muscles at the front,~     paraspinals and glutueal muscles on the back, diaphragm on the roof, oblique abdominal~     muscles on sides and hip joint and pelvic girdle at the base.~      With the activation of these muscles, both trunk stabilization is ensured and movement that~     emerges in the distal segments is supported by power generation and transfer. The location of~     the center of gravity in the space changes frequently with the movement of the body segments.~     Postural adjustments that required to restore the impaired balance due to this displacement~     of center of gravity, consist of lumbal stabilization with the activation of the core~     muscles.~      The upper extremity is a body part with a wide variety of abilities. With the same basic~     anatomical structures, the arms, forearms, hands and fingers may function differently. The~     upper extremity is the primary tool that people use to manipulate the environment. Therefore,~     mobility comes to the forefront rather than stability in the upper extremity. On the upper~     extremity, the most vital component in the transition from high-level mobility to~     functionality is the hand. The continuity of the kinetic chain is necessary for these~     functions to be carried out with biomechanical and kinesiologically correct patterns.~      The kinetic chain is a system that allows different body parts to produce coordinated power~     and collect and transfer it to the final connection point through muscle activity and body~     position. It is necessary to provide body stabilization by a strong core in order to achieve~     power transfer between the extremities and the trunk with the minimum loss of power due to~     this system. Core stabilization is defined as a prerequisite for the consist of movements~     involving the upper limb through regional biomechanical stabilization and power generation,~     transfer and control along the kinetic chain.~      The aim of this study planned in line with the available information is to investigate the~     effect of core stabilization exercises applied for 6 weeks on body balance and hand~     functions.~   "
9638|NCT03440671|"~     A Phase Ⅲ Clinical Trial to Compare the Safety and Efficacy of Hutox versus Botox® in Subject~     with Moderate to Severe Glabellar Lines~   "
9639|NCT03440658|"~     The purpose of this retrospective work is to study the consequences of obstetrical brachial~     plexus paralysis on the rotator muscles of the shoulder. First of all, the investigators want~     to study the reproducibility of the isometric contraction forces of the rotator muscles of~     the shoulder thanks to an isokinetic dynamometer. The investigatorsthen want to compare the~     measurements obtained from the paralyzed side compared to the healthy side. The preoperative~     MRI performed will be studied in search of amyotrophy. These data will be compared with those~     of the isokinetic assessment to identify children requiring muscle transfer of reinforcement~     of the external rotator muscles.~   "
9655|NCT03440437|"~     This study will be conducted in adult patients diagnosed with advanced tumors to characterize~     the safety, tolerability, pharmacokinetics (PK), and activity of FS118. This is a Phase 1,~     multi-center, open label, multiple-dose, first in human study, designed to systematically~     assess safety and tolerability, and to identify the maximum tolerated dose (MTD) and/or~     recommended Phase 2 dose (RP2D) for FS118 in patients with advanced tumors. Pharmacokinetics,~     pharmacodynamics, immunogenicity, and response will also be assessed.~   "
9640|NCT03440645|"~     Over a 12-month period, patients admitted with acute coronary disease to the cardiovascular~     care unit at the Jewish General Hospital (JGH), an academic tertiary care referral center in~     Montreal, Quebec, will be approached to refer first-degree relatives and/or household members~     age 18 years or older to an outpatient cardiovascular (CV) risk factor screening and~     treatment program. Relatives and household members will undergo a focused history, physical,~     and CV risk factor assessment and will receive evidence-based guideline-recommended treatment~     as indicated. Participants will be referred to nutritionists, smoking cessation programs, and~     to other allied healthcare professionals as needed. A follow-up visit at 6-months will assess~     treatment adherence and improvement in CV risk factors. All family and/or household members~     including the index patient will be encouraged to attend all healthcare visits together.~      The effectiveness of the screening strategy will be measured by the total number of~     participants identified as intermediate or high modified Framingham 10-year risk of~     cardiovascular disease. The effectiveness of the primary prevention intervention will be~     measured by the change in percentage of the mean modified Framingham 10-year risk score for~     participants between the initial visit and 6-month follow-up. The value of the referral,~     screening, and treatment program, as well as participant engagement and satisfaction will~     also be systematically evaluated.~   "
9641|NCT03440632|"~     Children with spastic cerebral palsy (CP) often walk with insufficient ankle dorsiflexion in~     the swing phase. A pathological gait, known as drop-foot gait, can be the result and this has~     2 major complications: foot-slap during loading response and toe-drag during swing. This is~     partly caused by weakness of the anterior tibial muscle and partly due to co-contraction of~     both the fibular- and anterior tibial muscle. For classification of gait, the Winters scale~     can be used, where unilateral CP with dropfoot is classified as type I.~      In daily life these problems cause limited walking distance and frequent falls, leading to~     restrictions in participating in daily life. The current guideline for spastic cerebral palsy~     describes the following therapies: 1) conservative therapy (physiotherapy, orthopaedic shoes~     and orthoses) 2) drugs suppressing spasticity 3) surgical interventions.~      Functional electrical stimulation (FES) may be an effective alternative treatment for~     children with spastic CP and a drop foot. By stimulating the fibular nerve or the anterior~     tibial muscle directly during the swing phase, dorsiflexion of the foot is stimulated. In~     contrast to bracing, FES does not restrict motion, but does produce muscle contraction, and~     thus has the potential to increase strength and motor control through repetitive neural~     stimulation over time.~      In a systematic review the investigators found that FES immediately improves ankle dorsal~     flexion and reduces falls and these effects also sustain. However, it should be noted that~     the level of evidence is limited. Until now, the use of FES in CP is limited and no data~     exist about the effects on walking distance (activity level) and participation level.~      The overall objective of this study is to conduct a randomised cross-over intervention trial~     in children with unilateral spastic CP with 12 weeks of FES (for every participant) and 18~     weeks of conventional therapy. The effectiveness of FES will be examined at participation~     leven, using individual goal attainment. Next to that the effect at gait will be measured. An~     additional goal is to investigate the cost effectiveness of FES, which, in case of a positive~     effect, may support allowance by insurance companies.~   "
9642|NCT03440606|"~     Background: The need for empathy and the difficulties of coping with morality when caring for~     the dying and the bereaved pose great psychological and spiritual strains. End-of-Life (EoL)~     care professionals including doctors, nurses and social workers are particularly prone to~     burnout given the intense emotional and existential nature of their work. Supervision is one~     important way to provide adequate support that focuses on both professional and personal~     competencies in working with death and loss. Previous research has provided strong evidence~     that support the inclusion of art therapy within supervision for it had effectively reduced~     burnout and enhanced emotional regulation. Combining the practice of mindfulness in~     art-therapy based supervision has immense potential to create a dynamic platform for~     self-care and collegial support, of which could ultimately cultivate sustained resilience,~     compassion and growth among those immersed the fields of hospice and palliative care.~      Methods/Design: A randomized wait-list control trial design. 60 EoL care professionals were~     randomly allocated into one of two groups: (i) Intervention group (MCAT Supervision), and~     (ii) Control group (MCAT Supervision will be provided after the intervention group completed~     all supervision sessions). Both quantitative and qualitative outcomes were assessed at~     baseline, immediately after intervention, and four weeks post intervention. Primary outcome~     measure included level of burnout. Secondary outcomes included death attitude and fear of~     death, emotional awareness and regulation, resilience, compassion, and overall quality of~     life. Qualitative data were analyzed using Framework method.~      Discussion: The integration of art and mindfulness practice to process the needs of~     professional EoL caregivers for self-care is a scarcely explored area in the field of hospice~     and palliative care in Singapore and in the international context. This pilot study proposes~     to develop and test a novel Mindful-Compassion Art Therapy (MCAT) Supervision for~     professional EoL caregivers. The expected outcome would generate new knowledge contributing~     to advancements in both theories and practice in hospice and palliative care for Singapore~     and across the globe.~   "
9643|NCT03440593|"~     Patients admitted to the ICU with diagnosis of sepsis and requiring mechanical ventilation~     for at least 24-hours and receiving enteral or parenteral nutrition will be prospectively~     randomized to one of two arms. Patients allocated to the estimated energy expenditure group~     will receive nutrition with caloric intake calculated based on the Penn State equation.~     Patients randomized to the measured group will receive nutrition with caloric intake~     calculated based on IC measurement present in the GE ventilator. Patients in the estimated~     group will have IC performed, but these data will not be used for prescription of nutrition.~     An equal number of beds within the ICU will be allocated to the measured group and the~     estimated group. The primary objective is to assess whether the utilization of indirect~     calorimetry for caloric goal calculation results in improvement in muscular structure, and~     consequent reduction of mechanical ventilation duration in patients with sepsis in comparison~     to utilizing the Penn State estimation equation for caloric goal calculation. The secondary~     objective is to assess whether the utilization of indirect calorimetry for caloric goal~     calculation results in improved adequacy of nutritional delivery in comparison to the~     adequacy of nutritional delivered when utilizing the Penn State estimation equation. Adult~     patients (> 18 years of age) admitted to the hospital with diagnosis of sepsis, and who~     require mechanical ventilation during hospitalization will be considered. Patients newly~     ventilated for at least one day but less than three days will be included in the study.~     Informed consent will be obtained from the legal authorized representative (LAR).~   "
9644|NCT03440580|"~     Physical inactivity is considered to be one of the ten principal risk factors for death~     worldwide. Children need to perform one hour of daily moderate-to-vigorous intensity physical~     activity whereof at least twice a week these activities are of vigorous intensity. In 2010,~     the percentage of 4-11 year-old normoactive Dutch children was approximately 20%.Previous~     interventions that aimed to increase childhood physical activity produced small to negligible~     effects. One possible explanation is that individuals were not intrinsically motivated~     towards physical activity during the intervention period. Children spend a substantial amount~     of their time behind a game consule. There are a number of applications that motivate~     increase in physical activity in a fun way through engaging individuals in games that mix~     real and computing worlds. These games became known as serious games. In this study we want~     to investigate if the incorporation of a serious game BOOSTH in combination with an activity~     tracker and battle to stimulate physical activity behaviour in primary school children~     (grades 5th to 7th).~   "
9645|NCT03440567|"~     This phase I trial studies the side effects and best dose of avelumab, utomilumab, rituximab,~     ibrutinib, and combination chemotherapy in treating patients with diffuse large B-cell~     lymphoma or mantle cell lymphoma that has come back or does not respond to treatment.~     Monoclonal antibodies, such as avelumab, utomilumab, and rituximab, may interfere with the~     ability of tumor cells to grow and spread. Ibrutinib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as~     etoposide phosphate, carboplatin, and ifosfamide, work in different ways to stop the growth~     of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Giving avelumab, utomilumab, rituximab, ibrutinib, and combination~     chemotherapy may work better in treating patients with diffuse large B-cell lymphoma or~     mantle cell lymphoma.~   "
9646|NCT03440554|"~     This study aims to learn how to improve MRIs (Magnetic Resonance Imaging) that do not require~     the patient to be injected with a contrast dye. Researchers expect to learn how to better~     find and describe tumors in patients with prostate cancer. Participants have a whole body~     research MRI scan within 90 days of a standard-of-care imaging procedure. The research study~     will collect copies of those scans to compare to the research scans as part of the study~     analysis.~      Patients who have additional standard-of-care scans within 12 months after their research~     scan may be asked to have a second non-contrast MRI for research within 90 days of their~     follow-up standard of care imaging. The whole body MRI scan will be compared to the~     standard-of-care scan for prostate cancer detection and to assess patient response to~     standard-of-care treatment.~   "
9647|NCT03440541|"~     Using of human amniotic membrane extra-cellular matrix as a topical treatment for improving~     Psoriasis Area and Severity Index (PASI).~   "
9648|NCT03440528|"~     To evaluate the using of a commercial product of dried human amniotic membrane sterilized by~     gamma irradiation for the treatment of skin ulcer.~   "
9649|NCT03440515|"~     To achieve optimal clinical outcomes with imatinib in GIST patients, it is crucial to~     maintain standard imatinib dose. Skin rash is a relatively common and sometimes severe~     adverse event of imatinib in GIST patients and may affect imatinib compliance. Our previous~     retrospective study suggested that severe skin rash induced by imatinib can be managed by~     systemic steroid without imatinib dose interruption or reduction. This phase II study was~     conducted to evaluate the efficacy and safety of systemic steroid in GIST patients with~     imatinib-associated severe skin rash.~   "
9650|NCT03440502|"~     The current study aimed at studying the effect of DM during pregnancy on the spinal block~     criteria during C.S.~      The primary end point of the trial is the incidence of complete failure of spinal block.~      Secondary endpoint is to determine the effect of DM on the other spinal block criteria as~     onset and duration of block, level of spinal block, rate of regression, hemodynamic changes,~     doses of inotropes and incidence of complications~   "
9651|NCT03440489|"~     Interstitial lung disease includes a heterogeneous group of chronic lung conditions that is~     characterized by exertional dyspnoea and poor health related quality of life . includes~     idiopathic pulmonary fibrosis of unknown cause And another groups are caused by occupational,~     inorganic or organic exposure, drug- induced toxicities, or are secondaries to connective~     tissue disease The clinical course and outcome of interstitial lung diseases are highly~     variable between different sub types, but survival after diagnosis of idiopathic pulmonary~     fibrosis is only 2.5 to 5 years is a progressive and fibrosing lung disease that is~     characterized by architectural distortion of the lung parenchyma and is progressive, with a~     dismal prognosis Also patient with idiopathic pulmonary fibrosis generally demonstrate~     greater abnormalities of exercise induced gas exchange than those with other forms of~     Interstitial lung disease~   "
9652|NCT03440476|"~     Heavy episodic alcohol use within the college student population is widespread, creating~     problems for student drinkers, their peers, and their institutions. Negative consequences~     from heavy alcohol use can be mild (e.g., hangovers, missed classes), to severe (e.g.,~     assault, even death). Although online interventions targeting college student drinking reduce~     alcohol consumption and associated problems, they are not as effective as in-person~     interventions. Online interventions are cost-effective, offer privacy, reduce stigma, and may~     reach individuals who would otherwise not receive treatment.~      In a recently completed randomized, controlled trial, an emailed booster with personalized~     feedback improved the efficacy of a popular online intervention (Braitman & Henson, 2016).~     Although promising, the booster incorporated in the study needs further empirical refinement.~      The current project seeks to build on past progress by further developing and refining the~     booster. In particular, one aspect missing from online interventions is a connection with a~     person invested in improving the student's outcomes. The current study aims to generate a~     personal connection for online interventions through a follow-up booster emailed by a member~     of the research staff. Outcomes will be compared for participants who receive a follow-up~     booster with similar content, but is clearly automatically generated and not from any~     particular individual.~      There are 3 conditions: all participants receive the initial online intervention targeting~     college drinking. Condition 1 (the control group) receives an email with a reminder to~     complete the follow-up surveys, but no feedback (i.e., no booster). Condition 2 receives an~     emailed booster with normative feedback plus protective strategies feedback, clearly~     automatically generated. Condition 3 receives an emailed booster with normative feedback plus~     protective strategies feedback, from a member of the research staff. The booster content~     alone (automatically generated) may be efficacious, or the additional personal connection may~     enhance the effect.~      Thus, the aim of the current study is to examine if personal contact enhances the tailored~     feedback received via booster email.~   "
9653|NCT03440463|"~     Heavy episodic alcohol use within the college student population is widespread, creating~     problems for student drinkers, their peers, and their institutions. Negative consequences~     from heavy alcohol use can be mild (e.g., hangovers, missed classes), to severe (e.g.,~     assault, even death). Although online interventions targeting college student drinking reduce~     alcohol consumption and associated problems, they are not as effective as in-person~     interventions. Online interventions are cost-effective, offer privacy, reduce stigma, and may~     reach individuals who would otherwise not receive treatment.~      In a recently completed randomized, controlled trial, an emailed booster with personalized~     feedback improved the efficacy of a popular online intervention (Braitman & Henson, 2016).~     Although promising, the booster incorporated in the study needs further empirical refinement.~     In addition, the intervention originally tested (Alcohol 101 Plus) is no longer widely~     available.~      The current project seeks to build on past progress by further developing and refining the~     booster. In addition, it examines the utility of the booster after a different, widely-used,~     empirically-supported online intervention (e-checkup to go). e-checkup to go directly~     provides personalized normative feedback, but not protective strategies, the two components~     of the examined booster. Hence, the current study compares the reinforcing content (normative~     feedback) to the combination of reinforcing and novel content (norms PLUS protective~     strategies). There are 3 conditions: all participants receive the initial online intervention~     targeting college drinking. Condition 1 does not receive a booster email. Condition 2~     receives an emailed booster with normative feedback only. Condition 3 receives an emailed~     booster with normative feedback plus protective strategies. The aims of the current study are~     as follows:~      Aim 1: Examine if novel feedback in the form of protective strategies enhances the~     reinforcing normative feedback received via booster email (i.e., a comparison of reinforcing~     normative feedback only versus reinforcing normative feedback plus novel protective strategy~     feedback).~      Aim 2: Examine previously identified potential moderators and mediators of reductions in~     alcohol use and related problems.~   "
9654|NCT03440450|"~     To determine the safety profile, maximum tolerated dose (MTD), dose-limiting toxicities (DLT)~     and recommended Phase 2 dose (RP2D) in patients who receive FF-10832 (Gemcitabine Liposome~     Injection) for treatment of advanced solid tumors.~   "
9656|NCT03440424|"~     This study will be conducted to assess the effect of mild and moderate hepatic impairment on~     the pharmacokinetics (PK) of lemborexant after a single-dose administration.~   "
9657|NCT03440411|"~     The combination lenalidomide plus low-dose dexamethasone (Rd) is an active treatment for~     Multiple Myeloma (MM) patients, both at diagnosis and at relapse.~      Pomalidomide, is an immunomodulatory molecule (IMID), derivative of thalidomide, developed to~     improve the efficacy and reduce the toxicity of the parent molecule. Pomalidomide and~     dexamethasone (pom-dex) proved to be an effective and safe treatment in MM patients~     refractory to lenalidomide and refractory/intolerant to bortezomib.~      The addition of chemotherapy to novel drugs has been evaluated both at diagnosis and at~     relapse. The combination of pomalidomide-cyclophosphamide-prednisone proved to be safe and~     effective in relapsed/refractory MM patients. The combination~     pomalidomide-cyclophosphamide-dexamethasone (pom-cyclo-dex) was tested in a phase II study in~     patients with relapsed and refractory MM, demonstrating a good tolerability using~     pomalidomide at the dose of 4 mg. Pom-cyclo-dex resulted in a superior response rate and PFS~     compared to pom-dex. The increased hematologic toxicities, as a result of the addition of~     oral cyclophosphamide, were manageable. With an overall response rate of 65% the combination~     demonstrated a promising efficacy.The first aim of our trial, is to compare the combination~     of pom-cyclo-dex vs pom-dex.~      Relapsed myeloma is defined as previously treated myeloma that progresses and requires the~     initiation of salvage therapy.~      According to IMWG recommendation, biochemical relapse is defined as an increase of ≥ 25% of~     tumor burden from lowest value, without any CRAB feature (CRAB is defined as the onset of~     clinical symptoms: hypercalcemia, renal failure, anemia and bone lesions) and detected in 2~     consecutive determinations.~      Clinical relapse requires one or more direct indicators of progressive disease and end organ~     dysfunction (CRAB features).~      Treatment at relapse should start in case of clinical relapse or a significant paraprotein~     increase (doubling of M-component in 2 months).~      In case of biochemical relapse the standard is observation only, as in case of asymptomatic~     MM at diagnosis.~      However, a recently published trial, showed improved PFS and OS for newly diagnosed~     asymptomatic patients treated with lenalidomide and dexamethasone in comparison with~     observation only. Our hypothesis is that similarly, in the relapse setting, patients may~     benefit from an early intervention, meaning a treatment at biochemical relapse and not only~     in case of clinical relapse or rapid increase of M-component.~   "
9658|NCT03440398|"~     This trial is designed to compare robotic nipple-sparing mastectomy and immediate robotic~     breast reconstruction with conventional open technique. It is a prospective randomized trial~     evaluating patients satisfaction~   "
9659|NCT03440385|"~     This is a Phase 3, randomized, double-blind, placebo-controlled study to explore the effect~     of oral ozanimod as an induction treatment for subjects with moderately to severely active~     Crohn's Disease.~   "
9660|NCT03440372|"~     This is a Phase 3, randomized, double-blind, placebo-controlled study to explore the effect~     of oral ozanimod as an induction treatment for subjects with moderately to severely active~     Crohn's Disease.~   "
9661|NCT03440359|"~     Aromatase inhibitors such as letrozole are hypothesized to maintain normal hypothalamic/~     pituitary feedback mechanisms and in the case of OI (ovulation induction) in women with PCOS,~     may act to increase follicular sensitivity to FSH by increasing intrafollicular androgen~     levels. Letrozole also may act to increase midluteal P levels presumably by induction of~     follicles and corpora lutea. The investigators are asking the question whether P~     supplementation with Crinone (8%) may have an additive beneficial effect on endometrial~     development in those women taking letrozole. Progesterone levels in the endometrium (tissue~     levels) have been documented to be significantly higher than serum levels after vaginal~     administration which may lead to higher pregnancy rates. In addition P has been shown to~     decrease LH pulse frequency which is elevated in PCOS and has been shown to down regulate~     endometrial androgen receptors. There have been retrospective studies showing progesterone~     supplementation seems to benefit both CC and letrozole treatment groups. In fact, this study~     showed the only pregnancies in the letrozole group were those in women who took P~     supplementation. However the number of cycles studied was small. There is a place for a~     randomized controlled trial (RCT) to determine if luteal phase P supplementation with Crinone~     should be used in all women using letrozole for Ovulation Induction (OI) in combination with~     Intrauterine Insemination (IUI) or Timed Intercourse (TI). This is currently not done in all~     clinical practices.~   "
9662|NCT03440346|"~     Attention deficit hyperactivity disorder (ADHD) is the most common childhood behavioural~     disorder, causing significant impediment to a child's development. The exact aetiology of~     ADHD is still unknown. It is a complex disorder with numerous contributing (epi)genetic and~     environmental factors. Currently, treatment predominantly consists of behavioural and~     pharmacological therapy. However, medication use is associated with several side effects and~     concerns about long-term effects and efficacy exist. Therefore, there is considerable~     interest in the development of alternative treatment options.~      Double-blind research investigating the effect of a few-foods diet (FFD) has demonstrated~     large improvements in ADHD symptoms. However, following an FFD requires great effort of both~     the child and parents. To make this treatment easier or potentially obsolete, it is important~     to understand how and in which children an FFD affects ADHD symptoms.~      The investigators hypothesise that an FFD affects brain function and behaviour, including~     ADHD symptoms, via the complex network of communication between the microbiota, gut and~     brain, i.e. the MGB axis. The aim of this study is to identify potential mechanism(s)~     underlying the impact of an FFD on ADHD symptoms and to identify biomarkers that predict the~     response to the FFD.~      100 boys with ADHD will follow the FFD for 5 weeks. After inclusion, all participants will~     start with a baseline period, during which they will maintain their regular diet. The~     baseline period ends at the end of week 2. Thereafter, participants will follow a 5-week FFD,~     preceded by a 1-week transition period. The FFD period ends at the end of week 8.~      At the end of the baseline period (i.e. at the end of week 2) and at the end of the FFD (i.e.~     at the end of week 8), fMRI scans will be made, blood and buccal saliva will be collected,~     and stool and urine will be handed in. Children will do computer tasks and parents will~     complete questionnaires to monitor ADHD and physical complaints. All samples will be analysed~     by researchers blinded to behavioural responses to the FFD. To assess the impact of the FFD~     on brain function and the MGB axis, associations between ADHD behavioural changes and changes~     in other primary and secondary study outcomes will be analysed.~      This study may lead to the identification of biomarkers that can predict the response to an~     FFD. Understanding which changes - induced by an FFD - lead to improvements in ADHD symptoms~     may provide new avenues for developing treatments. Ultimately, the findings may enable~     personalised intervention strategies based on an individuals' configuration of the MGB axis.~   "
9663|NCT03440333|"~     The traditional concept believes that the etiology of neonatal respiratory distress syndrome~     (RDS) is immature development of lung,especially the surfactant synthesis system,and RDS is~     still one of the major causes of mortality and morbidity in newborns, especially premature~     infants[1].In recent years, using pulmonary surfactant replacement therapy (PS treatment) in~     the treatment of respiratory distress syndrome (RDS) is a major breakthrough in neonatal~     medicine [2].Combined with clinical practice and experience,and through Meta analysis of~     related randomized controlled trials (RCTs),it confirms that natural surfactant treatment can~     reduce mortality,the incidence of pulmonary air leaks (pneumothorax and interstitial lung~     emphysema),and the incidence of bronchopulmonary dysplasia (BPD) or 28-day-old mortality.For~     RDS in preterm infants whose gestation is <35 weeks ,surfactant replacement therapy is also~     more effective than in nearly term and full term infants.Therefore, in the analysis of cases~     of different gestational age groups,the investigators should focus on the study of premature~     infants cases.Due to less relevant research for using PS treatment to cure newborn RDS in~     high altitude area,this retrospective study conducts statistics and analysis of recently~     three-year cases in some hospital of high altitude area,to explore the treatment effect of~     the high altitude region and the impact of altitude on the treatment.~   "
9716|NCT03439644|"~     This is a prospective, single-center study in normal subjects aged 20 to 89 years.~      The objective was to describe upper eyelid laxity by age group (20/29 years old, 30/39 years~     old, 40/49 years old, 50/59 years old, 60/69 years old, 70/79 years old and 80/89 years old)~     measured with the method of McNab and studying it according to her customary side of sleep.~     In addition, we evaluated a method for measuring tarsal laxity.~   "
9664|NCT03440320|"~     Aim 1: Develop and manualize the MY-Skills intervention. Using focus groups, clinical~     reasoning, literature, and findings from previously tested interventions of yoga and~     self-management, the researchers will develop, refine, and standardize the MY-Skills~     intervention for chronic pain. In parallel, the researchers will develop a control group that~     includes exercise and health and wellness education. The expected outcomes include MY-Skills~     intervention workbooks for participants and training and teaching manuals for~     interventionists leading the MY-Skills intervention group and control group.~      Aim 2: Assess feasibility and acceptability of MY-Skills and research procedures including~     planned assessments. In this small RCT, the researchers will examine feasibility and~     acceptability of the 8-week MY-Skills procedures and intervention compared to an exercise and~     health and wellness education control group. Participants will include 30 caregiving dyads~     randomly assigned to the two groups (15 dyads for My-Skills and 15 dyads for control group; N~     = 30 dyads/60 participants). The primary hypothesis is that MY-Skills will be feasible and~     acceptable to caregiving dyads, as measured by benchmarks for recruitment, screening,~     attendance, and completion of assessments and intervention. Surveys will be administered and~     focus groups will be conducted to understand participant satisfaction and experiences with~     MY-Skills. After each intervention session, interventionists, caregivers, and care recipients~     will rate their satisfaction with the session content and activities.~   "
9665|NCT03440307|"~     The purpose of this study is to determine whether a 3-week intervention reduces urinary~     Bisphenol A (BPA) in women with obesity~   "
9666|NCT03440294|"~     The purpose of this study is to investigate the effect of wearing both neoprene suit and life~     jacket on respiratory capacities at rest and cardiopulmonary capacities during exercise in~     windsurfers.~   "
9667|NCT03440281|"~     Study included all pregnant women admitted with threatened preterm labor during the study~     period. All participants underwent estimation of maternal serum homocysteine level and~     assessment of uterine artery Doppler indices.~   "
9668|NCT03440268|"~     This is a randomized clinical trial, double-blind, placebo-controlled study with the goal to~     assess the influence of using N-AcetylCysteyn (NAC) for prevention of AKI (Acute Kidney~     Injury) in post operatory of valve replacement until their discharge or death~   "
9669|NCT03440255|"~     This non-randomized, open-label study has the objective to study the effects and feasibility~     of Transauricular Vagus Nerve Stimulation (TaVNS) for patients suffering from Generalized~     Anxiety Disorder (GAD), Chronic Pain (CP) and Irritable Bowel Syndrome (IBS) in a private~     healthcare centre.~   "
9670|NCT03440242|"~     This is a non-masked, non-randomized, stratified, 4-arm parallel group, non-interventional~     study where subjects will be enrolled into one of four arms based on their habitual contact~     lenses. Subjects will be wearing their habitual contact lenses throughout the study and will~     be scheduled for morning and afternoon visits totaling 10 visits with a ~4-week washout~     period between visits 6 and 7.~   "
9671|NCT03440229|"~     A randomized double-blind study of the effect of carboxymethylcellulose (CMC) on stool~     microbiota composition, microbiota localization, and metabolic parameters in healthy~     subjects. It includes a 17-day in-patient stay, randomization to an emulsifier-free group or~     a CMC group with the same diet except baked goods/sorbet with added CMC at 15g/person/day.~   "
9672|NCT03440216|"~     Antibiotics are still most often administered on an empiric fashion, as defined for the~     general population with dosages only adapted based on weight and renal and/or hepatic~     functions. As a result, serum concentrations show important interpatient variations with the~     risk of being subtherapeutic or toxic. Recent studies with temocillin, ceftriaxone, or~     meropenem confirm this for patients in intensive care units.~      The aim of the study will be to measure the total and free concentrations of temocillin,~     ceftriaxone, and meropenem in patients hospitalized in Intensive Care Units for pulmonary~     infections or another infection for which one of the above mentioned antibiotics is~     indicated. Patients will be stratified according to the level of their renal function. The~     antibiotics will be assayed in plasma as well as other accessible fluids in order to assess~     their pharmacokinetic properties.~   "
9673|NCT03440203|"~     The trend of diabetes prevalence was increased by comparing these two national surveys in~     2009 and 2014. However, the studies only focused on the prevalence and risk of diabetes and~     non-communicable diseases in Myanmar. The study focused on the common complications of~     Diabetic Peripheral Neuropathy (DPN) is rare. The studies in other countries showed high~     prevalence rate and under-diagnosis of DPN. Most of the patients with DPN did not complain~     about their symptoms because of without prominent symptoms. DPN is the major complication of~     diabetes. According to the international studies, DPN has the hidden epidemic and is the~     common causes which can lead to disability and decreased the quality of life in diabetes.~     Therefore, the study focused on the prevalence of DPN and its impact on the ADLs is~     obligatory as the descriptive study to explore the actual situation.~      Nursing care is not only for the patients in the hospital but also for the people in the~     community. Moreover, the nurses have to focus on all levels of prevention. Diabetes is the~     lifelong diseases and accessibility of health care for everyone with diabetes is a very~     important issue in the era with increased prevalence of diabetes. Therefore, we all have to~     focus not only on the primary prevention but also on the secondary and tertiary prevention of~     diabetes. The secondary and tertiary prevention in the diabetic patients also means the~     primary prevention of other diseases and disabilities (the complications of diabetes). For~     diabetic neuropathic patients, maintaining normal daily living is very important liked~     everyone. After getting information about the prevalence of diabetic peripheral neuropathy,~     the future research can be focused on the prevention of diabetic peripheral neuropathy and~     its complications. Furthermore, the intervention to decreases the development of DPN and~     impact of DPN on the ADLs will be supported to study.~      The objective of this study is to evaluate the prevalence of DPN and DPNP in type 2 diabetic~     patients and impact on the activities of daily living. The descriptive, cross-sectional study~     design will be used in this study. The inclusion criteria are the person aged over 25 years~     of age who had already diagnosed type 2 diabetes mellitus, taking any anti-glycemic~     treatment. The persons who are suffering from neuropathy and neuropathic pain other than~     diabetes, severe illness of diabetic patients, mental illness and alcoholism will be excluded~     from this study.~      The patients who are coming to the diabetic clinic at the outpatient department of Yangon~     General Hospital (YGH), North-Okkalapa General Hospital (NOGH), East Yangon General Hospital~     (EYGH), West Yangon General Hospital (WYGH) in Myanmar will be collected as the sample.~     Convenience sampling method will be used in this study. The patients who meet the inclusion~     criteria and come to outpatient diabetic clinics at YGH, NOGH, EYGH, and WYGH will be chosen~     as a sample after obtaining informed consent. Sample size will be calculated by using formula~     described by Keysel et al. 975 participants will be used as the sample to cover the dropout~     rate 20%.~      Data collection will be done at this outpatients diabetic clinic of these four hospitals.~     After getting informed consent, the medical history of diabetic adults who meet the including~     criteria will be collected from medical records. Data collection will be done by using the~     standardized measurement tools [Patient Neurotoxicity Questionnaire (PNQ), short-form McGill~     Pain Questionnaire (SF-MPQ), and visual analog scale (0-100)] in Myanmar languages. All of~     the instruments had been tested the reliability of back to back translation by two translator~     independently. Demographic data and health history will also be collected at the start of the~     interview.~      Physical assessments will be done by using standardized instruments which used to test hand~     and leg functioning. The strength of hand grip and pinch force will be assessed in both~     hands. 10-g Semmes-Weinstein Monofilament (SWM) test will be measured in index and ring~     finger of both hands and four areas of the foot. Moreover, time up and go (TUG) will be used~     to collect data about walking time and gait in DPN patients.~      This study has already obtained ethical clearance from Nursing Science Ethical Review~     Committee, Graduate School of Health Sciences, Okayama University, Japan with the review~     number D1605. It will be carrying out after obtaining approval from Department of Medical~     Research, Myanmar. At the outset, informed consent will be obtained with detailed information~     about the purpose of research, the part they need to participate, possible benefits and their~     rights to withdraw.~   "
9674|NCT03440190|"~     Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the~     pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the~     pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery.~     Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological~     availability of medication. In this study we investigate the pharmacokinetic effects of~     bariatric surgery on methylphenidate.~   "
9675|NCT03440177|"~     Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the~     pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the~     pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery.~     Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological~     availability of medication. In this study we investigate the pharmacokinetic effects of~     bariatric surgery on ramipril.~   "
9676|NCT03440164|"~     Twenty-four healthy volunteers of both genders, aged 18 to 44 years old and body mass indexes~     between 18 to 27 kg/m2,were selected to participate in a two-way, balanced, prospective,~     blind, single-dose crossover study with a one-week wash-out period. It was assessed that~     volunteers were free from significant cardiac, hepatic, renal, pulmonary, neurological,~     gastrointestinal and hematological diseases. The volunteers clinical evaluation were~     determined by clinical examination, ECG, and the following laboratory tests: blood glucose,~     urea, creatinine, AST, ALT, GGT, alkaline phosphatase, total bilirubin and fractions, uric~     acid, total cholesterol, triglycerides, albumin and total protein, and routine urinalysis.~     All subjects were negative for HIV, HBV, and HCV.~   "
9677|NCT03440151|"~     The purpose of this study is to compare the oncological and functional results of the~     contralateral submental flap with primary closure for reconstruction of tongue squamous cell~     carcinoma.~   "
9728|NCT03439488|"~     The purpose of this study is to evaluate the safety and tolerability of JNJ-440 in healthy~     and Chronic Hepatitis B (CHB) participants after single and multiple doses; and to evaluate~     the pharmacokinetic (PK) of JNJ-440 in healthy participants and in CHB participants following~     single and multiple dose regimens, administered alone (healthy participants and CHB~     participants).~   "
9678|NCT03440138|"~     Aim: To define benchmark outcomes in minimally-invasive primary bariatric surgery.~      Design: Multicenter retrospective cohort study.~      Assessed outcomes: Morbidity as defined by the Clavien-Dindo classification for surgical~     complications, the Comprehensive Complication Index® (CCI®) at discharge, at 3 months and at~     latest follow-up. Evolution of body mass index (BMI) will be also analyzed.~      Hospital eligibility: High volume centers (> 200 bariatric operations per year) from at least~     three continents, maintaining a prospective database, as well as having published previously~     critically on their outcome.~      Study population: Adult patients who underwent primary minimally invasive (laparoscopic /~     robotic) Roux-en-Y gastric bypass or sleeve gastrectomy from 1st of June 2012 to 31st of May~     2017.~      Patient Exclusion criteria: detailed later.~      Data collection Deadline: 1st September 2017 - 30 April 2018~   "
9679|NCT03440125|"~     The beneficial analgesic effects of Rubefacenciae (redden skin substances), is known since~     1830 as a treatment for pain, cramps, and disorders of the musculoskeletal system. Herbal~     cataplasms containing rubefacient substances, such as Cayenne pepper, are commonly used as~     natural medications to treat painful or aching areas in the case of acute or chronic back~     pain, and rheumatisms. In Vienna and lower Austria, a Cayenne Pepper Cataplasm (CPC)~     application containing Cayenne pepper and Kaolin powder in mixed proportion, is commonly used~     to treat musculoskeletal conditions of pain especially of the low back. However, a concern~     about the safety of such applications was recently raised.~      Therefore, the aims of the present study are to evaluate the effects of 10x 20min CP~     cataplasm application as a single treatment or in combination with electrical stimulation and~     massage on selected functional and molecular parameters on i) healthy subjects and ii)~     subjects suffering from low back pain.~   "
9680|NCT03440112|"~     The arm of this study evaluates possible GABA-A receptor target engagement effects of the~     FDA-approved medication, clarithromycin, in the setting of Parkinson's disease. Two-thirds of~     the subjects will receive clarithromycin for 7-9 days, and 1/3 will receive a placebo.~     [11C]Flumazenil GABA-A receptor PET imaging will be used to assess target engagement effects.~   "
9681|NCT03440099|"~     In general, men and women experience differing degrees of age-related decreases in physical~     function, with women having a greater prevalence of functional limitations and disability. A~     key predictor of this decrease in functional capacity is the reduction in leg muscle maximal~     power (product of force and velocity), which can be improved with exercise training. However,~     the development of exercise interventions to optimally improve skeletal muscle function in~     older adults has been difficult, in part because we now know that men and women respond~     differently to the same exercise training stimulus. In fact, the fundamental mechanisms by~     which habitual exercise improves physical function in older adults are still not well~     understood. The proposed studies are designed to address these knowledge gaps by examining~     the molecular and cellular mechanisms underlying the response to two distinct exercise~     training paradigms, and determining how these responses differ between older men and women.~     The investigators hypothesize that molecular, cellular and whole muscle contractile~     performance will be most improved in men by traditional low-velocity, high-load resistance~     training, and in women by high-velocity, low-load power training. Moreover, sex-specific~     structural responses in myofilament remodeling, protein expression and post-translational~     modifications will explain these sex-specific performance adaptations to each modality. To~     test these hypotheses, data will be gathered from 50 healthy, sedentary older men and women~     (65-75 years) prior to and following a 16-week unilateral exercise training program in which~     one leg undergoes resistance training and the other power training. The Specific Aims of this~     project are to identify the sex-specific effects of low-velocity resistance training versus~     high-velocity power training on: Aim 1) skeletal muscle function at the molecular, cellular~     and whole muscle levels, and Aim 2) protein expression and modification as well as size at~     the molecular and cellular levels. The within subject, unilateral intervention design~     provides a powerful model to minimize the effects of between-subject variability, and the~     translational approach will take advantage of our unique expertise with state-of-the-art~     measures from the molecular to whole body levels.~   "
9682|NCT03440086|"~     Recent evidence has shown that the onset and intensity of post-operative pain are~     significantly related to the amount of residual pneumoperitoneum at the end of the surgical~     procedure. In addition, the use of low pressures of carbon dioxide (CO2) for induction of the~     pnemoperitoneum has been associated with a reduction in post-operative pain, probably due to~     a lower abdominal distension and a consequent reduced compression of the pelvic, abdominal~     and sub-diaphragmatic pain nerve fibers.~      The reduction of the residual pnemoperitoneum at the end of the surgical procedure could~     therefore play a key role in the reduction of post-operative pain, with consequent greater~     comfort for the patient and reduction of the use of analgesics.~      In view of the available evidence, the aim of the present study is to evaluate whether the~     application of Jackson-Pratt drain, for one hour from the end of the surgical procedure, can~     significantly reduce post-operative pain and the need of analgesics in patients undergoing~     laparoscopic gynecological surgery.~   "
9683|NCT03440073|"~     Women in rural communities receive less access to prenatal care, and experience slightly~     higher rates of complications during pregnancy. A very prevalent pregnancy related~     complication is Pregnancy Related Pelvic Girdle Pain (PPGP), effecting up to 76% of all~     pregnant women. Historically, PPGP has been thought to originate from hormonal changes~     associated with pregnancy, but its cause is more likely due to loss of motor control and/or~     malpositioning of the pelvic bones. Despite growing interest and clinical awareness of the~     condition, treatment outcomes of PPGP are inconsistent and intervention studies are lacking.~     The goal of this proposal is to investigate a treatment modality with minimal risks and~     potential to be self-administered. The Mulligan Concept manual therapy technique aims to~     restore mechanical function of the lumbopelvic region and has yet to be measured in women~     with PPGP.~   "
9684|NCT03440060|"~     This study assess whether a procalcitonin guided antibiotic therapy can reduce significantly~     unnecessary antibiotic prescription during severe exacerbation of COPD requiring mechanical~     ventilation without compromising patients' outcome. The first group of patients will receive~     systematically empiric antibiotic therapy and the second group will receive antibiotics only~     if procalcitonin value is at or greater than 0.25 ng/ml.~   "
9685|NCT03440047|"~     The purpose of this study is to see if advanced endoscopic imaging may be helpful to~     accurately distinguish pathological tissue from normal tissue and guide therapy of~     endoscopically identified pathology.~   "
9686|NCT03440034|"~     A study looking at the effect of pioglitazone in skeletal muscle of patients with sporadic~     inclusion body myositis (sIBM).~   "
9687|NCT03440021|"~     The aim of the present study is to investigate changes in neural activity (BOLD signal), as~     measured using fMRI, in brain areas associated with emotional and working memory during task~     performance after single-dose administration of a novel selective alpha2c adrenoceptor~     antagonist (ORM-12741) in healthy volunteers. Further, it will be explored whether ORM-12741~     affects connectivity between brain areas in rest, as measured using fMRI, and cognitive~     performance in the sample under investigation.~   "
9688|NCT03440008|"~     The Veteran population is prone to foot and ankle maladies from common injuries such as~     sprains, and diseases such as ankle osteoarthritis (cartilage damage). More specific to~     Veterans are prior service injuries of the foot and ankle, which historically account for~     nearly a quarter of injuries received. These injuries include bone fractures and ligament~     damage. Some of these injuries may lead to poor ankle joint alignment, which over time could~     lead to osteoarthritis due to abnormal wear on a day to day basis. The goal of this proposal~     is to use a novel technology - biplane fluoroscopy, to study the movement of ankles which are~     misaligned in subjects with ankle osteoarthritis. This proposal will also benefit current~     diagnostic methods with additional information. Last, this proposal will test the~     effectiveness of a conservative treatment (modified shoe insoles) to correct or reduce the~     misalignment in ankles. This proposal will create evidence about: the nature of ankle~     osteoarthritis, the accuracy of diagnosing alignment, and conservative treatment for patients~     with ankle OA.~   "
9689|NCT03439995|"~     The primary goal of this study is to assess whether ventilation of deceased organ donors with~     an open lung protective ventilatory strategy will improve donor lung utilization rates and~     donor oxygenation compared to a conventional ventilatory strategy.~   "
9690|NCT03439982|"~     The purpose of the study is to determine if fecal microbiota transplant (FMT) can reverse~     hepatic encephalopathy (HE) in cirrhotic patients who continue to have breakthrough episodes~     of HE despite maintenance therapy with lactulose and/or rifaximin or metronidazole.~   "
9691|NCT03439969|"~     To investigate the effects of using an intra-oral camera (IOC) during supportive periodontal~     therapy, and oral hygiene mobile text messages (SMS) between appointments on clinical,~     behavioral and psychological parameters of patients with gingivitis.~   "
9692|NCT03439956|"~     One of the most important downsides of endoscopic surgery is the need to remove surgical~     specimens of different sizes through very small incisions. This step should ensure the~     complete retrieval of the surgical specimen with concomitant preservation of its integrity~     (if possible) in order to avoid intraabdominal contamination of potentially infected or~     malignant tissues. Possibilities for specimen extraction during laparoscopy include~     minilaparotomy, enlargement of an ancillary port, transumbilical extraction, and transvaginal~     extraction through posterior colpotomy.~      Although recent evidence has already suggested that transvaginal extraction through posterior~     colpotomy is a safe and feasible option, to date there are no published data about obstetric~     outcomes after this procedure.~      For this reason, the current study aims to evaluate obstetric outcomes between women that~     underwent transvaginal specimen extraction through posterior colpotomy and women who did not.~   "
9693|NCT03439943|"~     The main objective of the study is to evaluate the effect of lixisenatide (20 μg/d), versus~     placebo, administered as add-on therapy with the usual antiparkinsonian treatment, on the~     progression of motor disability in patients with early PD in order to assess its potential~     disease-modifying effect.~   "
9694|NCT03439930|"~     The goal of this study is evaluate the effect of uni-axial versus multidirectional balance~     training on muscle reaction time in subjects with chronic ankle instability. Muscle reaction~     time is measured on a trapdoor simulating an inversion sprain before and after a 6 week~     lasting balance training protocol.~   "
9695|NCT03439917|"~     It will be evaluated whether carnitine, a dietary supplement, reduces liver fat and improves~     metabolism in individuals who have a high concentration of fat within their liver.~     Participants will be given either Carnitine or placebo, together with a meal replacement~     milkshake twice daily for 6 months.~   "
9696|NCT03439904|"~     The purpose of the study is to investigate the impact of pharmaceutical care on cancer pain~     treatment for opioid-tolerant outpatients~   "
9697|NCT03439891|"~     This study is designed to determine the best-tolerated dose and safety of sorafenib combined~     with the immune checkpoint inhibitor, nivolumab, in treating participants with hepatocellular~     carcinoma (primary liver cancer) that cannot be removed by surgery. Sorafenib may stop the~     growth of cancer cells by blocking some of the enzymes needed for cell growth. Immune~     checkpoint inhibitors, such as nivolumab, may help the immune system inhibit the cancer.~   "
9698|NCT03439878|"~     This study aims to assess the postprandial triglyceride response to the ingestion of a~     high-fat meal with co-ingestion of either galactose, or glucose.~   "
9699|NCT03439865|"~     The purpose of this pilot study is to explore wither ivacaftor in refractory CRS patients~     will demonstrate safety and tolerability; restore CFTR-mediated Cl- secretions as measured by~     EDSPD testing; produce detectable improvements in validated measures of CRS including the~     SNOT-22 questionnaire, Lund-MacKay CT scan grading, and Lund-Kennedy endoscopic scores; and~     provide beneficial effects on readily measured markers of sinonasal inflammation and~     infection (IP-10, IL-8, and Pseudomonas CFUs).~   "
9700|NCT03439852|"~     The outcomes of this application will provide nursing researchers with information about ways~     to increase physical activity (PA) and decrease sedentary time (ST) in at-risk older~     Filipinos adults who are lay leaders in Filipino Catholic clubs in Hawaii. The proposed~     12-week PA/ST program will include both a group-based component (3 group discussions during~     monthly club meetings) and a personalized telephone counseling component (12 weekly calls~     from nursing students to problem solve barriers to increasing light-to-moderate physical~     activity and decreasing / breaking up sedentary time). The project will stimulate~     multidisciplinary research at our School of Nursing and School of Medicine and has the~     potential to help older at-risk Filipinos reach national guidelines for healthy levels of~     physical activity and lower the amount of time they spend sitting/being sedentary.~   "
9701|NCT03439839|"~     The main purpose of this study is to evaluate the efficacy of LNP023 in patients with PNH,~     showing signs of active hemolysis despite treatment with SoC (defined as an antibody with~     anti C5 activity).~   "
9702|NCT03439826|"~     Observational study~   "
9703|NCT03439813|"~     The TASK (Treating Anxiety after StroKe) trial is a feasibility randomized controlled trial.~     It aims to evaluate the feasibility of i) web-enabled trial procedures, and ii) the TASK~     intervention in stroke and TIA patients~   "
9729|NCT03439475|"~     Expanded access requests for AMG 714 may be considered for adult patients with biopsy proven~     Refractory Celiac Disease Type II who have failed all available treatment options and do not~     have EATL. To request access, use Responsible Party contact information provided in this~     record.~   "
9704|NCT03439800|"~     INTRODUCTION: Mental practice (MP) and action observation (AO) are characterized as cognitive~     strategies that contribute to motor planning and learning in diverse populations. Individuals~     with Parkinson's Disease (PD) are recent targets, since, with disease progression, they need~     external strategies to aid in motor organization. However, there is still no evidence of the~     efficacy of MP and AO in the gait of PD. OBJECTIVES: To compare the effects of physical~     practice preceded by MP and AO on gait performance in individuals with Idiopathic PD (IPD).~     METHODS: A controlled, randomized, single-blind clinical trial with 66 individuals with IPD,~     aged between 50 and 75 years, without cognitive deficit and in the moderate phase of the~     disease will be performed. For the inclusion and characterization of the sample, the~     following instruments / equipment will be used: (1) Identification form (sociodemographic,~     clinical and anthropometric aspects); (2) Mini Mental State Examination and Montreal~     Cognitive Assessment (cognitive level); (3) Hoehn and Yahr Scale (level of physical~     disability); (4) Revised Movement Imagery Questionnaire (sharpness of the mental image); (5)~     Qualisys Motion Capture Systems® (gait kinematics); (6) Emotiv Epoc +~     (electroencephalographic activity); (7) Unified Parkinson's Disease Rating Scale - UPDRS~     (motor function and activities of daily living); (8) Timed Up and Go Test - TUG Test~     (mobility); and (9) Parkinson's Disease Questionnaire - PDQ-39 (quality of life).Participants~     included will be randomly assigned to two groups: experimental (n = 33), who will participate~     in MP + AO and physical gait practice; and control group (n = 33), who will participate only~     in the physical practice of gait. Both groups will be submitted to 12 training sessions (3x /~     week, for 4 weeks) and will be reevaluated 10 minutes, 7 days and 30 days after the last~     training session with respect to items (4), (5), (6) and (8) of the evaluation. Primary~     outcomes will be velocity, stride length and range of motion of the hip and the secondary~     ones will be sharpness of the mental image, electroencephalographic activity and performance~     in the TUG Test. The normality in the data distribution will be verified through the~     Shapiro-Wilk test. The t test and the Mann-Whitney test will be used to verify the~     homogeneity of the groups in the baseline. A repeated measures ANOVA will verify the~     interaction between the groups at the moments observed.~   "
9705|NCT03439787|"~     This study aims to assess the analgesic effect of the popliteal plexus block as a supplement~     to a femoral triangle block in patients undergoing total knee arthroplasty~   "
9706|NCT03439774|"~     The study will assess the CT-800 and TRK-2P for conformity to ANSI Z80.10-2014 Ophthalmic~     Instruments - Tonometers, to the FDA Guidance for Industry and FDA Staff, Tonometer-Premarket~     Notification [510(k)] Submissions, and to the applicable Supplemental Information Sheet. This~     clinical device study will also assess the substantial equivalence of TRK-2P to a predicate~     device in regard to pachymetry.~   "
9707|NCT03439761|"~     Use PT-112 alone for Phase I dose escalation stage: advanced solid tumors, Phase I dose~     confirmation stage: advanced solid tumors. Phase II hepatocellular carcinoma (HCC). To~     evaluate the safety and tolerability of PT-112 injection from 250mg/m2 dose level with 3+3~     dose escalation design, find Maximum tolerated dose (MTD), Recommended Phase II Dose(RP2D)~     and evaluate the Pharmacokinetic (PK) profile of PT-112 through Phase I dose escalation~     stage. Phase I dose confirmation stage: evaluate the safety and tolerability of PT-112 with~     RP2D, evaluate the anti-tumor effect of PT-112 at RP2D. Phase II stage: evaluate the~     anti-tumor effect of PT-112 at RP2D in advanced HCC~   "
9708|NCT03439748|"~     Affect, or the tendency to experience a given emotion, often is subdivided into two domains.~     Positive affect is the tendency to experience positive emotions, such as happiness,~     excitement, elation, and enthusiasm. Negative affect is the tendency to experience negative~     emotions, such as anger, resentment, sadness, anxiety, and fear. Humans exhibit a range of~     emotions that span across positive and negative affect domains with some individuals~     experiencing more of one type of affect than another. Recent research and developing theories~     have suggested that mental health disorders can be conceptualized as the tendency for an~     individual to fall into one or more extremes on these categories. Therefore, treatments~     should not be based on targeting a conglomeration of symptoms (as we have been doing for the~     past century) but rather they should be treating the underlying dysregulation (e.g., high or~     low positive and negative affect).~      In an effort to address this gap, the current study plans to recruit participants for a~     treatment trial consisting of two psychotherapies: (a) positive affect treatment (PAT), and~     (b) negative affect treatment (NAT). The overarching goals of this project are to evaluate~     the efficacy of PAT and to identify whether aspects of positive or negative affect moderate~     (i.e., effect) the degree of response to these treatments.~      Participants will be randomized to either a 15-week positive (PAT) or negative affect~     treatment (NAT). Participants will also complete three laboratory visits (before treatment,~     after treatment, and at 6-month follow-up) to examine potential moderators of treatment.~     These laboratory based assessments will included measures of the positive and negative affect~     system such as behavioral and psychophysiological responses to reward, fear conditioning and~     extinction, recovery from distress, and positive and negative imagery as well as diagnostic~     interviews.~   "
9709|NCT03439735|"~     The goal of this research study is to determine if we can predict which participants will~     respond to an aromatase inhibitor and palbociclib for metastatic breast cancer and which~     participants will not. Investigators will use information from the tumor tissue and serial~     blood samples. Investigators hope that a deeper understanding of which participants will~     respond to this combination and how resistance emerges will allow the investigators to better~     tailor therapies for metastatic breast cancer.~      Subjects will have archived tissue or new biopsy collected at study enrollment. This tissue~     will undergo special molecular testing. Subjects will also have blood collected at study~     enrollment and periodically thereafter. This blood will also undergo special molecular~     testing. Information from this testing will not be available to subjects or their treating~     physicians as the investigators do not know how this information should impact treatment.~      The investigators will collect information about which treatment the subjects receive and how~     their cancer responds.~      Any man or woman being seen at Johns Hopkins for treatment of newly diagnosed estrogen~     receptor positive (ER+) and/or progesterone receptor positive (PR+) metastatic breast cancer~     may be eligible.~   "
9710|NCT03439722|"~     Sleep study in episodic cluster headache patients.~   "
9711|NCT03439709|"~     In this study, the investigators hypothesize that upfront gamma knife radiosurgery with drug~     therapy is superior in the treatment of growth hormone-secreting pituitary tumors after~     primary surgical treatment compared with the drug therapy alone. This study can provide~     useful clinical information in the treatment of patients with acromegaly.~   "
9712|NCT03439696|"~     The investigators' study aims is to evaluate the safety and efficacy of uniportal VATS under~     assistance of needlescopic instruments through additional 2-3 mm ports compared to~     conventional uniportal VATS in patients with lung lesions.~   "
9713|NCT03439683|"~     The investigators developed a web-based survey to assess knowledge, attitudes and practice of~     health care professionals about patient-ventilator asynchrony.~   "
9714|NCT03439670|"~     Brief Summary: This Phase IIb study is a randomized, double-blind, parallel group, placebo~     and active-controlled study to evaluate the efficacy, safety, PD, and population PK of~     vamorolone administered orally at daily doses of 2.0 mg/kg and 6.0 mg/kg versus prednisone~     0.75 mg/kg/day and placebo over a Treatment Period of 24 weeks, and to evaluate persistence~     of effect over a Treatment Period of 48 weeks in ambulant boys ages 4 to <7 years with DMD.~   "
9715|NCT03439657|"~     The purpose of this study is to assess immunogenicity and safety of GSK Biologicals' HZ~     vaccine when its first dose is co-administered with a pneumococcal polysaccharide conjugate~     vaccine (Prevenar13) in adults aged ≥50 YOA, as compared to the control group where the two~     HZ/su doses are administered subsequent to Prevenar13.~   "
9717|NCT03439631|"~     Operating room (OR) costs consume a significant portion of hospital budgets. Standard or~     Status Quo ORs are equipped with the same, fixed set of assigned resources, regardless of~     case complexity or actual resource requirements. Allocation of resources in standard ORs is~     the same whether the participant is having heart surgery or bunion removal.~      The investigators propose a strategy for OR design and set up wherein resources are carefully~     matched to procedure complexity as a novel means of healthcare delivery.~      This prospective, comparative cohort pilot study will compare two operating room (OR) setup~     designs. The Tiered OR setup (study intervention) will be an efficiently staffed and equipped~     OR, geared to the complexity of the surgical procedure. The level of care provided would be~     equivalent to that of an out-patient day surgery setup. The Status Quo OR setup (control~     intervention) will be a standard fully equipped, fully staffed OR.~   "
9718|NCT03439618|"~     In the nutrition guideline (A.S.P.E.N guideline), there was no recommendation about the~     feeding type in enteral feeding of critically ill patients. Continuous feeding is the most~     popular feeding type in ICU because of its less nursing burden and reducing the aspiration~     incidence theoretically. However, some previous studies demonstrated that there were no~     complications differences between continuous and time-restricted feedings（such as~     intermittent feedings）.~      In ICU, the disorder of protein synthesis is a universal problem and is associated with ICU~     acquired weakness. Time-restricted feeding is more physical than continuous feeding. In some~     animal researches, time-restricted feeding was proved to have a greater stimulatory effect on~     protein synthesis than continuous feeding. Besides of light, time-restricted feeding can may~     also adjust the biological rhythms. It is known that biological clocks could affect energy~     metabolism, emotion and so on. Until now, there are no enough clinical studies to prove the~     advantages in time-restricted feeding in ICU patients.So researchers designed the study to~     compare the time-restricted feeding and continuous feeding effect(especially protein~     synthesis) on ICU patients.~   "
9719|NCT03439605|"~     This study will be investigating how a common blood test for identifying heart damage~     (Troponin T) is affected by red blood cell damage in the blood sample (Haemolysis). It is~     already known that damage to the red blood cells during or after blood sample collection can~     cause falsely low test results however the exact amount is not clear. Some previous studies~     suggest that a much higher amount of red blood cell damage could be allowable when reporting~     the test results. This study will mimic the type of red blood cell damage that occurs in the~     hospital and determine what degree of damage or 'haemolysis' causes a significant reduction~     in the test result and therefore determine an allowable limit for safely reporting the test~     result. The results of this study may help provide an evidence based approach to improving~     current practice and may lead to fewer rejected blood samples, fewer repeat tests, improved~     A&E treatment times, general cost savings and an improved service to patients.~   "
9720|NCT03439592|"~     Hyperglycemia is a common finding in patients diagnosed with acute coronary syndrome (ACS),~     and an independent predictor of mortality in patients with and without diabetes. Though~     percutaneous coronary intervention (PCI) is the cornerstone of ST-segment elevation~     myocardial infarction (STEMI), the incidence of heart failure, re-infarction and death in~     hyperglycemic patients remains significant, with a mortality of more than 40% one year after~     the event. In these STEMI patients dual anti-aggregation therapy is currently the gold~     standard after PCI, but bleeding phenomena, and therapeutic resistance may reduce their~     therapeutic efficacy. Therefore, it is likely that the individual response to the dual~     anti-aggregation therapy, and the hyperglycemic stress, may influence resistance mechanisms,~     and/or lead to an increase in pharmacological functional deactivation by the microbiotic~     flora. The term microbiota indicates the totality of the genomes of microorganisms that~     reside in an ecological niche, and which constitute the human microbiota. In this context,~     the analysis of the faecal microbiota before PCI, at hospital discharge and at follow-up,~     could be considered useful for identifying hyperglycaemic patients with alteration of~     metabolic-oxidative processes, and pro-thrombotic correlates with worse post procedural~     prognosis. Therefore, the analysis of faecal microbiota during the STEMI event could~     theoretically identify hyperglycemic patients with excessive inflammatory and oxidative tone~     caused by hyperglycemia, conditioning resistance to double anti-aggregation therapy and~     coronary stenting, and conditioning pro-thrombotic phenomena after coronary reperfusion by~     PCI. Therefore, authors will conduct a study to analyze the microbiota in patients with acute~     hyperglycaemic and normoglycemic coronary syndrome. The primary objective of this study will~     be to evaluate any changes in the microbiota and its activity on faecal material taken before~     PCI, and after 6 and 12 months in patients with hyperglycemic STEMI, and also evaluate if the~     changes in the microbiota can be related to the 12-month prognosis.~   "
9721|NCT03439579|"~     The goal of the project is to test a remotely delivered, standalone behavioral weight loss~     intervention designed to help adults initiate the important dietary, physical activity (PA)~     and behavioral changes necessary to achieve weight loss.~   "
9722|NCT03439566|"~     This study wishes to investigate if pain by peripheral venous cannulation (PVC)~     preoperatively, will predict pain levels after 24 h postoperatively. Furthermore, to~     investigate moderate/severe pain at the postoperatively at the post-anaesthesia care unit~     (PACU) is associated with increased late (24h) pain. Additionally, if the PACU nurse is able~     to predict if the patient will be a high pain responder, by using a clinical judgement.~     Finally to evaluate the patient's pain-levels at home after discharge and investigate for~     associations between postoperative pain and post-discharge pain.~   "
9723|NCT03439553|"~     Bing ads designed to encourage people to adopt healthier practices (e.g., stop smoking,~     become physically active, stop consuming harmful content) are shown using the advertising~     system, to test which ads are more effective as apparent in the subsequent queries to Bing~     submitted by users who saw the ads.~   "
9724|NCT03439540|"~     Effect of oral supplementation with Plantago major on cardiometabolic risk factors and~     mineral content and lifestyle in obese women: double-blind, randomized clinical trial.~   "
9725|NCT03439527|"~     The rising success of cell therapies places an increasing burden on health care costs.~     Consequently, the need to reduce production costs while maintaining quality has been widely~     acknowledged. In addition, the demand for high-quality products with an optimal safety~     profile is increasing. The proposed cell treatment is the first therapeutical option with the~     possibility to revert the underlying condition. The investigators expect that this healing~     response will be achieved with minimal side effects justifying the addional costs and~     complexity.~   "
9726|NCT03439514|"~     This is a randomized, double-blind, placebo-controlled study in patients with dilated~     cardiomyopathy (DCM) due to a gene encoding the lamin A/C protein (LMNA) mutation. The study~     will further evaluate a dose level of ARRY-371797 that has shown preliminary efficacy and~     safety in this patient population. After the primary analysis has been performed, eligible~     patients may receive open-label treatment with ARRY-371797.~   "
9727|NCT03439501|"~     This study was conducted to evaluate the complete response rate of avelumab in patients with~     NK / T-cell lymphoma besides relapsed or refractory stage lymphoma.~   "
9733|NCT03439423|"~     The aims of this study are to verify non-inferiority of magnetic resonance (MR) without~     contrast agent associated to color-Doppler ultrasound for the diagnosis of endoleaks after~     endovascular aortic repair (EVAR), to evaluate both the economical and biological~     cost-effectiveness of such diagnostic algorithm as an alternative to computed tomography (CT)~     with contrast agent, and to analyze its impact on both patients work-flow and infrastructure~     logistics~   "
9734|NCT03439410|"~     The progressive rising of multimorbidity, which has been always considered the hallmark of~     clinical complexity (CC), has made management of the complex patient one of the most~     topical and challenging issues in medicine. However, patient-related factors (multimorbidity,~     age, frailty, disease severity) pertain only to the biological complexity, while CC is the~     result of the dynamic interaction between biological complexity and a number of other~     coexisting factors (socio-economic, cultural, behavioural, environmental). Starting from~     these premises, the investigators designed a five-year observational prospective longitudinal~     study that aims to validate and compare a CC score system on a large cohort of patients~     (n=1000) admitted in internal medicine wards. Clinicians, biostatisticians and~     epidemiologists will cooperate into the project. A questionnaire that encompasses the main~     biological and extra-biological factors was designed (Clinical Complexity Index, CCI) by a~     multiprofessional consensus. This questionnaire will be administered by the investigators to~     the patients and validated. Consecutive patients will be enrolled every other week for two~     years and followed-up for 5 years. The primary endpoint will be the validation of the CCI.~     Thereafter, the investigators will evaluate the correlation between the CCI and the length of~     stay of the index hospitalization, assuming that a higher CCI score is associated with longer~     length of stay. The secondary endpoints will be the demonstration of the association between~     higher CCI score and more health resources utilization (i.e., evaluating occurrence of~     hospital readmissions, number of accesses to the emergency room, visits at the outpatient~     clinic, different drugs prescribed and hospital reimbursement according to the local~     diagnosis-related group [DRG] system) along with worse prognosis (mortality at 1 and 5~     years).~   "
9735|NCT03439397|"~     Retinoblastoma is the most common intraocular tumor in children..IAC--Targeted Treatment for~     Intraocular Retinoblastoma,Is minimally invasive procedure that infuse chemotherapy select~     into the ophthalmic artery, its can increasing the drug concentration reaching the tumor and~     reducing systemic toxicity compared with traditional intravenous treatment.: one is Ballon~     technique , another is selective ophthalmic artery infusion.This study evaluates the~     difference of Ballon technique and selective ophthalmic artery infusion effect in the~     treatment of retinoblastoma. Half of participants will receive, Ballon technique while the~     other half will receive selective ophthalmic artery infusion~   "
9736|NCT03439384|"~     Modern technology like computers, smartphones and the internet enable patients to measure~     certain health indicators like blood pressure and body weight from the comfort of their own~     homes. This information can also be shared electronically with doctors and other healthcare~     providers. This is called home health monitoring. In TEC4Home, the investigators are~     developing a home monitoring solution for patients with heart failure to support their care~     and recovery after a visit to the emergency department. The investigators hypothesis is that~     TEC4Home will be a cost-effective strategy to decrease 90-day Emergency Department (ED)~     revisits and hospital admission rates, and improve self-management and quality of life for~     patients with Heart Failure (HF).~   "
9737|NCT03439371|"~     This study aims at evaluating the safety and the tolerance of the micro-transplantation in~     elderly patients with acute myeloid leukemia who are ineligible to conventional allogeneic~     transplantation.~   "
9738|NCT03439358|"~     Magnesium has been shown to decrease the shivering experienced from neuraxial anesthesia.~     This study aims to investigate whether magnesium decreases the shivering experienced in~     parturients undergoing labor epidural anesthesia for Cesarean delivery.~   "
9739|NCT03439345|"~     LENS is a streamlined multicentre randomized placebo-controlled parallel-group trial~     investigating the effect of fenofibrate treatment on the progression of diabetic~     retinopathy/maculopathy~   "
9740|NCT03439332|"~     Despite an aggressive therapeutic approach, the prognosis for most patients with glioblastoma~     (GBM) remains poor. The relationship between non-invasive Magnetic Resonance Imaging (MRI)~     biomarkers at preoperative, postradiotherapy and follow-up stages, and the survival time in~     GBM patients will be useful to plan an optimal strategy for the management of the disease.~      The Hemodynamic Multiparametric Tissue Signature (HTS) biomarker provides an automated~     unsupervised method to describe the heterogeneity of the enhancing tumor and edema areas in~     terms of the angiogenic process located at these regions. This allows to automatically draw 4~     reproducible habitats that describe the tumor vascular heterogeneity:~        -  The High Angiogenic enhancing Tumor (HAT)~        -  The Less Angiogenic enhancing Tumor (LAT)~        -  The potentially tumor Infiltrated Peripheral Edema (IPE)~        -  The Vasogenic Peripheral Edema (VPE)~      The conceptual hypothesis is that there is a significant correlation between the perfusion~     biomarkers located at several HTS habitats and the patient's overall survival.~      The primary purpose of this clinical study is to determine if preoperative vascular~     heterogeneity of glioblastoma is predictive of overall survival of patients undergoing~     standard-of-care treatment by using the HTS biomarker.~   "
9741|NCT03439319|"~     A two-arm, parallel group, multicentre, single-blind, randomized controlled trial comparing~     electrical neuromodulation delivered by MyndMove® therapy to intensive upper-limb~     conventional therapy in the treatment of patients with moderate to severe motor impairment to~     their arms and hands from an incomplete, sub-acute, traumatic spinal cord injury.~   "
9742|NCT03439306|"~     The purpose of this study is to evaluate the oxygen saturation accuracy performance of Belun~     Ring Oximeter placed on the index fingers during non-motion conditions~   "
9743|NCT03439293|"~     The purpose of this study is to evaluate the efficacy and safety of ixazomib in combination~     with daratumumab and dexamethasone in participants with relapsed and/or refractory myeloma.~   "
9744|NCT03439280|"~     The purpose of this study is to assess the safety, tolerability, maximum tolerated dose~     (MTD)/recommended phase 2 dose (RP2D) in Phase 1 of the study and to provide a preliminary~     evaluation of the clinical activity of TAK-079 monotherapy in participants with r/r MM in~     Phase 2a of the study.~   "
9745|NCT03439267|"~     The primary objective of this study is to test the effectiveness of a proactive~     cardiovascular primary prevention strategy, with or without the use of coronary calcium~     screening, compared to present standard care, in preventing future major adverse cardiac~     events (MACE), including all-cause death, non-fatal myocardial infarction (MI), stroke, or~     any arterial revascularization among a moderate risk population with no present evidence of~     cardiovascular disease.~   "
9746|NCT03439254|"~     The primary objective of this study is to evaluate whether obeticholic acid (OCA; INT-747)~     can lead to histological improvement in fibrosis with no worsening of NASH in adults with~     compensated cirrhosis due to NASH.~   "
9748|NCT03439228|"~     The use of a lumbar brace following single-level lumbar fusion for degenerative spondylosis~     (non-traumatic) is variable between surgeons. Some surgeons prefer to prescribe a brace and~     others do not. There is a lack of guidelines and evidence to support either treatment option.~     The purpose of this study is to assess feasibility and collect preliminary data to conduct a~     larger, definitive trial to provide evidence as to whether prescribing a brace or not results~     in better or equal outcomes. Imaging by CT scan, one year after surgery, will be used to~     analyze bone fusion (healing), and functional and pain scores from patients during their~     recovery will be compared to identify differences between patients who wore a brace and those~     who did not.~   "
9749|NCT03439215|"~     This is a phase II study assessing response rate to PF-06463922 in patients with ROS1~     translocation resistant to previous crizotinib therapy. Eligible patients will be treated~     with the study drug until disease progression, unacceptable toxicity or patient refusal.~     Disease assessment will be performed every 8 weeks according to RECIST criteria.~   "
9750|NCT03439202|"~     The main goal of this project is to investigate how low intensity cycling exercise (1.5W/kg,~     for 6 minutes) influences cerebral functions, such as: Cerebral blood flow, oxygenation, and~     other physiological variables in different normobaric and hypobaric hypoxic conditions.~   "
9751|NCT03439176|"~     The adhesion of the new adhesive strips is investigated on healthy volunteers~   "
9752|NCT03439163|"~     Resting-state functional magnetic resonance imaging (RS-fMRI) has frequently been used to~     investigate local spontaneous brain activity in Parkinson's disease (PD) in a whole-brain,~     voxel-wise manner. To quantitatively integrate these studies, we conducted a coordinate-based~     meta-analysis on 15 studies that used amplitude of low frequency fluctuation (ALFF) and 11~     studies that used regional homogeneity (ReHo). All these ALFF and ReHo studies have compared~     PD patients with healthy controls. We also performed a validation RS-fMRI study of ALFF and~     ReHo in a frequency-dependent manner for a novel dataset consisting of PD and healthy~     controls.~   "
9753|NCT03439150|"~     In acute myocardial infarction, early restoration of blood flow to the jeopardized myocardium~     is of paramount importance to limit infarct size and to improve long term outcome. Primary~     percutaneous coronary intervention (PPCI) is the treatment of choice in these patients.~     Despite achievement of adequate epicardial coronary artery reperfusion in many patients,~     transient or persistent myocardial microvascular dysfunction is often present, also referred~     to as the no-reflow phenomenon. This microvascular dysfunction and the time course during~     which it recovers, is most likely also related to long term outcome.~      If microvascular reperfusion is still limited immediately after myocardial infarction but~     recovers quickly in the days thereafter, this might be beneficial for long term prognosis.~      Several treatments have been suggested to limit microvascular injury and to improve~     microvascular reperfusion in the acute phase of myocardial infarction (such as intra-aortic~     balloon pumping, glycoprotein IIB/IIIA inhibitors, adenosine, verapamil, nitroglycerine,~     cyclosporine, or gap-junction-inhibitors), but it has been difficult to assess the effect of~     such treatment due to the simple fact that no methodology has been available for quantitative~     assessment of the microcirculation of the heart.~      Assessment of microvascular perfusion and function has been very difficult so far and has~     been hampered by a number of methodological and technical shortcomings. Measurement of~     absolute blood flow in the infarcted area and true quantitative calculation of absolute~     resistance in acute myocardial infarction, has been introduced in the last years using a~     technique with thermodilution and continuous infusion of small amounts of saline. This~     technique offers the possibility to study the course of microvascular (dys)function after~     acute myocardial infarction with potentially important implications for treatment at~     follow-up. Technical performance of such measurements was difficult so far because of a~     complex instrumentation and the necessity of additional administration of intravenous~     adenosine. In the last 2 years, this technique has been largely simplified by the~     introduction of a new multipurpose monorail infusion catheter (RayFlow ®, Hexacath, Paris)~     and the observation that saline infusion of 15-20 ml/min in itself already ensures maximum~     coronary hyperemia. Finally, easy to handle software has been developed for online~     interpretation of such measurements. Consequently, measurement of absolute blood flow and~     myocardial resistance has become easy to perform now and the complete measurements only take~     a few minutes in addition to a regular PPCI or Fractional Flow Reserve (FFR) measurement. The~     measurements are absolutely safe, reproducible, only a small amount of saline (100 ml at room~     temperature) is needed, no additional medication is necessary, the patient doesn't experience~     any discomfort of the measurement and the measurements can be repeated multiple times within~     minutes.~      Therefore, a window is opened for further examination and quantitative assessment of the~     microcirculation of the heart. The purpose of the present study is to evaluate changes in~     myocardial resistance over time in ST-Elevation Myocardial Infarction (STEMI) patients, both~     in the early stage and the subacute phase. Furthermore, the course of such changes and~     recovery of the microcirculation will be correlated to long-term outcome as assessed by~     Magnetic Resonance Imaging (MRI) measurements and final infarct size. It is hypothesized that~     patients can be divided into 3 groups:~      A. Patients with an (almost) normal resistance and flow immediately after PPCI B. Patients~     with still elevated resistance and decreased flow immediately after PPCI, but (partial)~     recovery in the next days C. Patients with elevated resistance and decreased flow immediately~     after PPCI which do not recover at all.~      The investigators would like to evaluate changes in microvascular resistance of the infarcted~     area in the first hour after ST-elevation myocardial infarction and during the recovery~     period (<5 days). Classify patients according to recovery of microvascular resistance and~     relate the (recovery of) microvascular resistance to outcome and preservation of left~     ventricular function (with MRI, echo and clinical follow-up at 1 year).~   "
9754|NCT03439137|"~     For hemodialysis subjects currently receiving ESAs with anemia associated with chronic kidney~     disease, demonstrate non-inferiority of MT-6548 compared to darbepoetin alfa using Hb value~     and evaluate long-term safety of MT-6548.~   "
9755|NCT03439124|"~     This is a study of the safety and efficacy of ceftobiprole in pediatric patients with~     hospital-acquired bacterial pneumonia (HAP) or community-acquired bacterial pneumonia (CAP)~     requiring hospitalization.~   "
9756|NCT03439111|"~     Lycium chinense fruit (LCF) is widely distributed in East Asia that has been used~     traditionally for anti-aging purposes. This study was performed to examine the effects of LCF~     on attention and cognitive function in healthy young people. An 11-week, double-blind,~     randomized, placebo-controlled, crossover trial was conducted.~   "
9757|NCT03439098|"~     The objective of this study is to demonstrate the cognitive enhancement effect and safety of~     Fermented Codonopsis lanceolata, using the cognitive and clinical indicators (e.g. memory,~     attention, and psychomotor speed) and the latest brain imaging methods for healthy adults~     suffering subjective cognitive impairment.~   "
9758|NCT03439085|"~     The goal of this clinical research study is to learn if the combination of MEDI0457 and~     durvalumab can help to control cancers related to the Human Papilloma Virus (HPV). The safety~     of this combination therapy will also be studied.~      MEDI0457 is given using a procedure called electroporation, or EP. EP is the delivery of~     low-voltage electric pulses to the muscle tissue after injection of the MEDI0457. EP is~     designed to make MEDI0457 more effective.~      This is an investigational study. Durvalumab is FDA approved and commercially available for~     the treatment of urothelial cancer. It is not approved for use in patients with the types of~     cancer that are being enrolled on this study. Neither MEDI0457 nor the use of EP are FDA~     approved or commercially available for the types of cancer in this study. They are currently~     being used for research purposes only.~      The study doctor can explain how the study drugs are designed to work.~      Up to 77 participants will be enrolled in this study. All will take part at MD Anderson.~   "
9759|NCT03439072|"~     This is a non-inferiority, multi-center, randomized, controlled, single-blind, two-way~     crossover efficacy and safety study in subjects with Type 1 diabetes mellitus. The study~     involves two daytime clinical research center (CRC) visits with random assignment to receive~     G-Pen™ glucagon 1 mg during one period and Lilly Glucagon 1 mg during the other. Each daytime~     visit is preceded by an overnight stay in the CRC. In the morning of the inpatient study~     visit, the subject is brought into a state of hypoglycemia through IV administration of~     regular insulin diluted in normal saline. After a hypoglycemic state with plasma glucose < 50~     mg/dL is verified, the subject is administered a dose of G-Pen or Lilly Glucagon via~     subcutaneous injection. Plasma glucose levels are monitored for up to 180 minutes~     post-dosing, with a value of >70.0 mg/dL within 30 minutes of glucagon administration~     indicating a positive response. After 3 hours, the subject is given a meal and discharged~     when medically stable. After a wash-out period of 7 to 28 days, subjects return to the CRC,~     and the procedure are repeated with each subject crossed over to the other treatment. A~     follow-up visit as a safety check is conducted 2-7 days following administration of the final~     dose of study drug.~   "
9770|NCT03438929|"~     The objective of this clinical study is to evaluate safety and efficiency of Diolase XL~     blended modes for hair removal. The handpieces tested were a blend of 755nm/810nm and~     810nm/1064nm. At least 30 female subjects seeking hair removal treatment will be enrolled.~     Treatment sites will be o groins and axillae. Study design included 3 treatment sessions 4~     weeks apart and follow-up after 3 months.~   "
9799|NCT03438539|"~     The purpose of this study is to test the feasibility and acceptability of delivering~     cognitive training over mTurk. Subjects will be randomized to a 1) inhibitory control~     training condition, 2) working memory training condition, or 3) control training condition.~     Recent studies have also demonstrated the feasibility and potential efficacy of delivering~     brief normative feedback to reduce alcohol consumption through mTurk. In these brief~     interventions, subjects are provided information about their drinking compared to their same~     age and gendered peers. Approximately half of the subjects in each cognitive training group~     will receive normative feedback to evaluate effects on alcohol consumption and possible~     interactions with cognitive training. This study will focus on alcohol use given the ease and~     clinical acceptance of alcohol use self-report as a primary outcome.~   "
9760|NCT03439059|"~     With the nation's fastest growing demographic being adults over 65, one in every three~     seniors is estimated to die from Alzheimer's Disease (AD). The strong correlation between AD~     and age, combined with the exponential growth of this demographic, highlights the need for~     non-pharmaceutical treatment/prevention strategies. Research has established a relationship~     between moderate to vigorous physical activity (PA) and improved cognitive functioning.~     However, there is insufficient evidence to support this relationship at the lower end of the~     PA spectrum. Assisted living facilities (ALF) are an easy target for reducing SB, as many~     individuals in these facilities have various functional limitations and therefore cannot meet~     the recommended PA guidelines. Older adults are also the most sedentary population, with~     results showing over 8.5+ hours daily spent in SB. ALF typically provide meals, laundry~     services as well as housekeeping duties, leaving the residents very susceptible to large~     amounts of SB. The primary purpose of my study is investigating how reducing sedentary~     behaviour (SB) in ALF will affect Alzheimer's Disease Assessment Scale-cognitive scores among~     65-85-year-olds with mild-to-moderate cognitive impairment. I will also investigate its~     effects on physical functioning with the Timed Up and Go test (TUG), quality of life with the~     Short Form 36 (SF-36) Health Survey, and sleep with the Mpow IP68 tracker. Participants will~     be prompted to take a 10-minute light intensity PA break at three different time points~     throughout the day, reallocating SB to any task equating to over 1.5 metabolic equivalents.~     Positive findings may encourage ALF to implement policies and procedures regarding SB.~   "
9761|NCT03439046|"~     The purpose of this clinical trial is to study of the molecular features of postmenopausal~     women with hormone receptor-positive (HR+) HER2-negative advanced breast cancer on first-line~     treatment with ribociclib and letrozole.~   "
9762|NCT03439033|"~     This is a study primarily comparing Magnetic Resonance Imaging (MRI) alone to Positron~     Emission Tomography (PET)/MRI using an experimental tracer, 68Ga-PSMA-HBED-CC, among men with~     prostate cancer or prostatic cancer recurrence/metastasis. It is hypothesized that this~     comparison will demonstrate that PET using the tracer, 68Ga-PSMA-HBED-CC, is more sensitive~     than MRI alone. Potential subjects who cannot undergo MRI may undergo PET/CT instead.~   "
9763|NCT03439020|"~     The aim of this study is to demonstrate that the group with an additional plastic stent to~     anchor the fully covered self expandable metal stent (FCSEMS) in patients with malignant~     biliary stricture has less stent migration than the group with FCSEMS only. The primary~     outcome is stent migration for 6 months. The secondary outcomes are stent related adverse~     events, stent patency, and overall survival.~   "
9764|NCT03439007|"~     The purpose of this study is to find out which of the variables related to fluid~     responsiveness (e. g., perfusion index [PI], pleth variability index [PVI], pulse oximetry~     plethysmographic variance [ΔPOP]) can best predict hypotension during induction of~     anesthesia.~   "
9765|NCT03438994|"~     The primary aim of this study is to compare the diagnostic accuracy of an iPad application~     (Play.Care assessment) with the current clinical gold standard diagnosis for diagnosis of~     Autism Spectrum Disorder (ASD) in children. Recent evidence has suggested that movement~     abnormalities are one of the early markers of ASD. However, current clinical diagnostic~     assessments fail to take this into account. Further, the current gold standard clinical~     tests take a number of hours to administer, require extensive clinical training and are~     subject to a certain level of subjectivity. Alternatively, by assessing a child's interaction~     with an iPad screen as they play, an objective measurement of movement can be obtained, which~     can aid in the diagnostic process.~      This study aims to recruit a total of 760 children (Typically Developing (TD), Other~     Neurodevelopmental Disorders (OND) and ASD groups) to assess the diagnostic accuracy of~     tablet game play in ASD. Children who have been diagnosed with ASD will perform the Play.Care~     assessment to assess if the tablet result matches their clinical diagnosis. Results from the~     clinical assessment and Play.Care assessment will then be compared to assess the sensitivity~     (the proportion of participants with ASD who test positive for ASD as a result of the~     Play.Care assessment) and specificity (the proportion of participants without ASD who test~     negatively for ASD as a result of the Play.Care assessment assessment) of the Play.Care~     assessment.~   "
9766|NCT03438981|"~     WP2.1. PK/PD target attainment Plasma exposure ELF exposure WP2.2. Predictive dosing~     algorithm WP2.3. Validation WP2.4. ECMO subset~   "
9767|NCT03438968|"~     Cardiovascular disease (CVD) is highly prevalent in women resulting in 398,086 deaths~     annually. Even as women participate in traditional CR programs, data specificity and~     subsequent research have yet to emerge in a meaningful way so that women-centered CR can be~     better customized and their outcomes properly assessed. Aerobic fitness is a powerful~     predictor of prognosis in individuals with CVD yet there is evidence that women do not~     improve their peak VO2 as much as men during CR. We have designed a training program for~     women based upon past research with a goal of optimizing their training potential in CR. This~     program combines the utilization of a training technique termed high intensity interval~     training along with specific strength training exercises of the upper legs. We hypothesize~     that women, irrespective of age, would be capable of high intensity interval training to~     improve peak aerobic capacity in the CR setting. Furthermore, since women often have a~     deficit of thigh strength entering CR, and thigh strength correlates with endurance~     walking,strength training will also be included. The purpose of this study is to examine the~     value of high intensity interval training and strength training to maximize aerobic training~     response in CR for women. This may contribute to establishing specific protocols and training~     guidelines for future program design for women in CR. Since a set of comprehensive CR~     guidelines pertaining to women is lacking, it is hoped that the results of this study will~     help us develop exercise protocols and regimen to better structure and modulate CR programs~     for optimal benefit to women.~   "
9768|NCT03438955|"~     This study evaluates the safety and pharmacokinetic drug-drug interactions of omega-3 and~     atorvastatin in healthy male volunteers. Half of the participants will receive omega-3 for 16~     days to be steady state of omega-3 and followed by omega-3 and atorvastatin in combination~     for 7 days. The other half will receive Atorvastatin for 7 days to be steady state of~     Atorvastatin, and followed by Atorvastatin and Omega-3 in combination for 16 days.~   "
9769|NCT03438942|"~     The aim of the study is to determine the factors affecting the bioavailability of iron and~     folic acid during the simultaneous use of iron supplements and folic acid supplements in~     non-pregnant women of childbearing age.~   "
9771|NCT03438916|"~     Background:~      Standardization and new therapeutic treatments of variceal bleeding has significantly reduced~     the mortality the last 25 years, but there is still a high 6-week mortality around 15-20% and~     1-year mortality of about 40%. Cirrhotic patients without prophylactic treatment suffer a~     risk of 60% of re-bleeding within the first year after the first bleeding episode. Variceal~     ligation and NSBB are the standard therapy as secondary prophylaxis, while only non-selective~     beta-blocker (NSBB) is offered as first-line therapy in primary prophylaxis. If portal~     pressure is reduced to a value below 12 mmHg or by 20% (10% if assessed by intravenous~     administrations), the risk of bleeding is substantially reduced, but not all patients respond~     to the treatment with propranolol (40-50%). Hence, patients who are non-responders to NSBB~     should be offered alternative treatment with e.g. carvedilol, which is a combined~     alpha-beta-receptor blocker or endoscopic band ligation. Currently, the response to NSBB is~     assessed invasively during a liver vein catheterization (LVC). Unfortunately, only a few~     centres in the world can perform this procedure and there are no reliable non-invasive~     alternatives to assess the respond to NSBB, which is of extreme importance, since~     non-responders have three fold increased risk of a new variceal bleeding episode.~      Aim:~      In general the aim of the project is to develop faster and non-invasive methods to evaluate~     portal hypertension and individual pharmacological response of NSBB in patients with~     cirrhosis. Furthermore, we expect to detect changes in liver and spleen stiffness as measured~     by MR-Elastography (MRE) after NSBB and that these depend on the drug-related effects on~     portal pressure.~      Study design and patients:~      39 patients with cirrhosis and esophageal varices that require NSBB (propranolol) treatment.~      Patients are assessed with LVC, MR-scans, echocardiography and biochemical tests. LVC is the~     gold standard method to test if patients respond to propranolol treatment. At visit 1. the~     response to NSBB is defined as a reduction of HVPG ≥10%, or to a HVPG< 12mmHg after~     intravenous NSBB administrations during LVC. MRI-scan with intraveneus NSBB administration is~     performed at visit 2. Minimum 5 days of NSBB wash out between visit 1 and 2.~   "
9772|NCT03438903|"~     Comparison of intradevice repeatability of thickness measurements for macular area in the~     eyes with normal and various retinal diseases using SS-OCT and SD-OCT~   "
9773|NCT03438890|"~     The aim of this study is to compare three popular methods of minimizing or reducing~     laparoscopic lens fogging (LLF) by heating lens using warm saline, applying anti-fog agent to~     lens, and rubbing lens with chlorhexidine in laparoscopic gynecologic surgery.~   "
9774|NCT03438877|"~     This is a multicenter, pilot RCT study, aiming to compare intensive dosage and regular dosage~     of PD for AKI patients with indications for dialysis.~      Aims of the study are to:~      Examine the efficacy and safety of intensive PD for AKI patients as compared to regular PD.~      Establish the appropriate workflow for PD treatment for AKI patients.~   "
9775|NCT03438864|"~     Interferential current is a form of electrotherapy that is obtained by placing two different~     plates that produce medium frequency waveform current, resulting in a low frequency~     interferential waveform in deeper tissues. It was shown interferential current electrotherapy~     is beneficial for reduction of traumatic edema in tissues and pain control.~      Patients with conservatively managed distal radius fractures were recruited after casts are~     shed, and were treated with one session(30 minutes) of different protocols of interferential~     current electrotherapy. Before and after therapy, they were evaluated with volumetry, hand~     grip strength and visual analogue scale for pain.~   "
9776|NCT03438851|"~     Symptoms resulting from mild/moderate trauma to the brain are as varied as the individuals~     who sustain them. The currently held belief is that the majority of healing and functional~     recovery occurs within the first two years post injury. A large proportion of individuals who~     sustain mild/moderate brain injuries (mTBIs) do not fully recover, and continue to experience~     symptoms well beyond two years post injury. Cognitive rehabilitation programs have been shown~     to be somewhat effective in helping mTBI patients regain some functionality in these~     executive domains.~      The purpose of the current study is to use an objective assessment of brain function to track~     changes during either a full-time or part-time holistic cognitive rehabilitation program,~     specifically the Watson Centre for Brain Health (WCBH) program. The NeuroCatch Platform™ test~     will be used to assess brain functioning before, during and after 3 months in the WCBH~     program. The NeuroCatch Platform™ test uses electroencephalography (EEG) to measure~     event-related potential (ERP) signals produced by the brain, in response to an auditory~     stimulus. Three brain processes are examined with this test: Auditory sensation (ERP marker~     is the N100), Basic attention (ERP marker is the P300), and Cognitive processing (ERP marker~     is the N400).~   "
9777|NCT03438838|"~     Back ground: Achalasia Cardia (AC) manifests with major symptom dysphagia. Surgery as the~     treatment modality relieves dysphagia in most of the patients. Laparoscopic Heller's~     myotomy(LHM) is the surgery of choice but is associated with gastroesophageal reflux.~     Anterior fundoplication (Dor Fundoplication) is usually combined with LHM in patients with~     AC. It reduces gastroesophageal reflux following LHM. It has been observed that along with~     reduction of gastroesophageal reflux Dor Fundoplication also affects relief of dysphagia. But~     it has not been prospectively studied.~      Hypothesis:The hypothesis of present study is that Frequency of dysphagia following~     Laparoscopic Heller's myotomy with Dor fundoplication is more than that compared to~     Laparoscopic Heller's myotomy alone in patients with Achalasia Cardia.~      Methods: From December2017 to November 2018 minimum of 20 patients with diagnosis of~     Achalasia cardia will be randomized to receive either Laparoscopic Heller's myotomy (LHM)~     alone or LHM with Dor fundoplication. Symptomatic outcomes would be assessed using frequency~     of dysphagia and Eckardt's score. .~      Outcomes: Primary outcome is Frequency of dysphagia and secondary outcome is manometry~     pressure assessment. Statistical analysis would be done using Statistical Package for the~     Social Sciences (SPSS) soft ware. P value < 0.05 is considered significant.~   "
9778|NCT03438825|"~     The PREPARE-MVR (PRediction of Early PostoperAtive Right vEntricular failure in Mitral Valve~     Replacement/Repair patients) Study aims to evaluate those preoperative factors which can~     predict the early postoperative right ventricular failure or determine the functional shift~     seen in right ventricular function after mitral valve replacement/repair. The PREPARE-MVR~     study focuses mainly on echocardiographic (both conventional and advanced) parameters and~     includes right heart catheterization intraoperatively and in the early postoperative period~     as gold standard method.~   "
9779|NCT03438812|"~     To investigate whether the DHEA supplementation could improve mitochondrial quality in poor~     ovarian responders~   "
9780|NCT03438799|"~     This is a multi-center, observational, non-interventional, prospective, Single-arm, open~     study for database establishment for R&D purposes. R&D data will be analyzed retrospectively~     in order to validate algorithm efficacy.~      The study will be conducted in the following settings: hospital (admission due to CHF~     exacerbation), CHF clinic and at home.~   "
9796|NCT03438578|"~     The primary aim of this project is to determine whether postoperative patients may benefit~     from the Efficacy Safety Score (ESS) as a tool for postoperative clinical decision support,~     with a special focus on the first 24 hours after discharge from the postoperative care unit.~   "
9781|NCT03438786|"~     Mesh repair of inguinal hernia is the most common operation performed on general surgical~     patients. Approximately 20 million groin hernioplasties are performed each year worldwide.~     Countless studies have been reported in the medical literature in attempts to improve the~     overall outcomes following hernia operations and, due to this fact, the procedure has evolved~     immensely, especially over the last few decades. Recurrence of inguinal hernia was initially~     a significant problem. Lichtenstein repair (LR), recurrence rate has consistently been~     reported as low as 1-4%[2], a drop from up to 10%. But increased incidence of chronic groin~     pain following LR.~      Transinguinal preperitoneal (TIPP) inguinal hernia repair with soft mesh has been reported as~     a safe anterior approach with a preperitoneal mesh position .~      Theoretically, TIPP repair may be associated with lesser chronic postoperative pain than~     Lichtenstein's technique due to the placement of mesh in the preperitoneal space to avoid~     direct regional nerves dissection and their exposure to bio-reactive synthetic mesh. The~     placement of mesh in this plane without using any suture for fixation and lack of mesh~     exposure to regional nerves was assumed to result in the reduced risk of developing chronic~     groin pain. So aim of our study to prove less hospital stay and complication and cost~     effectiveness for preperitoneal meshplasty~   "
9782|NCT03438773|"~     This investigator-initiated post-marketing study will evaluate the role of Hispanic ethnicity~     on drug dosing of Envarsus in first-time stable renal transplant recipients. Tacrolimus~     trough drug levels will be studied as a primary endpoint at 24 hours after drug dosing and at~     steady state (e.g., trough level at 3 months post conversion) and secondary compliance~     assessments will be done by pill counts at clinic visits. Secondary outcomes will be the~     safety of once a day dosing as well as assessment of graft rejection and graft failure. In~     addition, concentration/dose ratios will be analyzed. The results of this study will provide~     important information about dosing of once a day tacrolimus (Envarsus) in Hispanic kidney~     transplant patients, which represents the largest growing group of patients with End-Stage~     Renal Disease~   "
9783|NCT03438760|"~     The sophisticated language of science can be a barrier to Science, Technology, Engineering,~     and Math (STEM) learning, especially for children who have specific language impairment~     (SLI). The purpose of this randomized controlled trial is to test vocabulary and grammar~     interventions embedded in a small-group inquiry-based science instruction for their potential~     to ameliorate language deficits that impede science learning. Participants will be 54~     kindergartners with SLI. Proximal and distal probes will reveal their mastery of taught and~     generalized language and science concepts.~   "
9784|NCT03438734|"~     Obesity is a chronic disease that affects quality and duration of life negatively. It's not~     clearly known the effects of low flow anesthesia on cerebral oxygenation with high-risk~     morbidly obese patients. In this study, it was aimed to compare the effects of general~     anesthesia with low flow (0,75 L/min) and normal flow (1,5 L/min) on cerebral oxygenation and~     depth of anesthesia in morbidly obese patients in bariatric surgery.~   "
9785|NCT03438721|"~     Latino children experience higher rates of obesity compared to non-Hispanic white children,~     especially in low-income communities. Optimal feeding strategies in early life, avoidance of~     screen time and longer sleep duration may lower the risk of obesity. Family financial~     hardship is also associated with short- and long-term health risks, including behavioral and~     mental health problems, and toxic stress which contributes to elevated risk of common chronic~     conditions over the life course. This proposal aims to pilot test two interventions to~     promote optimal health outcomes in Latino infants. Study participants will meet with a health~     educator after well child visits at 2-weeks, 2-, 4-, 6-, 9- and 12-months. Half of the~     parents will receive education on obesity prevention. The other half will receive financial~     education and case management using an established financial coaching approach. Parents will~     also receive text messages that reinforce educational content. The objective of this study is~     to determine the acceptability and feasibility of offering these interventions in the~     well-child setting. Study investigators also seek to determine the preliminary efficacy of~     these interventions on infant and parent health outcomes including dietary intake, screen~     time, sleep duration, health related quality of life and financial stress.~   "
9786|NCT03438708|"~     This is a single arm phase II study of axitinib in patients with clear cell renal cell~     carcinoma (RCC) with strong indications for partial nephrectomy (PN) for whom PN is not~     currently possible due to anatomic considerations and residual renal function concerns.~     Evaluation of tumor downsizing will be performed including changes of tumor complexity by~     nephrometry score. A total of 50 participants will be enrolled.~      It is hypothesized that pretreatment with axitinib will be safe and improve the feasibility~     of complex nephron sparing surgery in select patients with localized clear cell RCC and~     imperative indications for partial nephrectomy.~   "
9787|NCT03438695|"~     Study design Prospective bicentric non-controlled clinical trial~      Study purpose~      - to evaluate the efficacy and safety of Novel Motorized Spiral Enteroscopy (NMSE) for total~     enteroscopy in patients with suspected small bowel diseases with an indication for direct~     visualization of the entire small bowel~      Primary objective~      Rate of total enteroscopy by means of NMSE with:~        1. a complete anterograde approach~        2. or a combined anterograde and retrograde approach~      Secondary objectives~        -  Procedural success of anterograde and retrograde approach~        -  Procedural time (minutes)~        -  Depth of maximum insertion (cm)~        -  Diagnostic yield~        -  Therapeutic yield~        -  Adverse events~   "
9797|NCT03438565|"~     The objective of this study is to obtain post market data on the Asahi Chikai Black 18~     neurovascular guidewire in the treatment of intracranial large vessel occlusive stroke. This~     will be compared to a historical control that will include the prior 50 consecutive patients~     fitting the same selection criteria.~   "
9798|NCT03438552|"~     Stereo-Re-Pro aims to provide further evidence of Stereotactic Body Radiotherapy (SBRT) as a~     supplementary non-invasive curative treatment for local recurrence following radiotherapy.~      The objective of the first part of the trial (Phase I) is to select the recommended dose for~     salvage SBRT (either 5 x 6 Gy, 6 x 6 Gy, or 5 x 5 Gy) based on dose-limiting toxicity~     observed during the 18 weeks following the initiation of salvage-SBRT. Particular attention~     will be paid to the quality of life and tolerance of the treatment.~      The objective of the second part of the trial (phase II) is to estimate the efficacy of the~     salvage-SBRT in terms of biochemical relapse-free survival rate.~   "
9788|NCT03438682|"~     More than 345,000 U.S. women undergo either tubal ligation (getting her tubes tied) or~     Essure procedures each year to permanently avoid pregnancy. Both prevent pregnancy by~     blocking women's Fallopian tubes but neither are 100% effective. Both can have complications,~     but not enough is known to help women make an informed choice between the two.~      Essure is popular because it can be performed without anesthesia in a doctor's office and~     women can return to work the next day. However, patients have reported that the Essure~     procedure was unexpectedly painful. Also, women need to use other contraceptives for 3 months~     and then return for testing, to make sure their tubes are blocked and will prevent pregnancy.~     Not all women return for this test and some may get pregnant before realizing their Essure~     didn't work.~      Essure was approved by the Food and Drug Administration (FDA) in 2002, but no studies ever~     compared it to tubal ligation. By 2015, over 9,000 women reported serious complications to~     the FDA. Women who were unhappy with Essure found each other online and created a Facebook~     Essure Problems support group that now has over 31,000 members. After an FDA Advisory Board~     expressed concerns about Essure's risks, in 2016 the FDA required stronger warnings about~     complications and announced that more rigorous research was needed, demanding Essure's~     maker conduct a new study comparing the benefits and risks of Essure to tubal ligation.~     Unfortunately, that study will not be finished before September 2023.~      To provide answers as rapidly as possible for women considering sterilization, we will~     analyze data from the medical records of thousands of women with sterilization procedures~     funded by California's Medicaid. As poor women and women of color have different experiences~     with healthcare, and they more often choose sterilization, comparing these women's~     experiences with Essure and tubal ligation is very important. We will compare the safety and~     effectiveness of the 2 sterilization procedures to answer:~        -  How many women got pregnant afterwards?~        -  How many operations did each woman need to become infertile?~        -  Which complications did women have (i.e. chronic pain, depression)? We will also check~          whether certain women (such as certain age groups or those with diabetes) were most~          likely to have problems after either procedure.~   "
9789|NCT03438669|"~     Patient-reported vision-related quality of life (QOL) outcomes are increasingly incorporated~     into clinical trials of new treatments for age-related macular degeneration (AMD). In~     patients with central visual field defects they often do not correlate with distance visual~     acuity changes as evaluated according to the Early Treatment Diabetic Retinopathy Study~     (ETDRS) protocol. Therefore there is the need for better correlated visual acuity (VA)~     outcome measures for these patients. In a current big trial for treatment of dry AMD~     (geographic atrophy) reading speed and low luminance visual acuity are used as outcome~     measures for the first time. However, limited information is available regarding the~     associations between distance ETDRS visual acuity, reading speed, low luminance visual~     acuity, contrast sensitivity, morphological parameters and the National Eye Institute Visual~     Function Questionnaire-25 (NEI VFQ-25) subscales judged relevant to these measures.~     Evaluating these correlations could provide the basis for objective study outcome parameters~     which are better correlated to patient-reported outcomes. Further it increases the~     understanding of the impact of visual impairment on activities and functioning in patients~     with eye diseases.~      There is an immediate benefit to the study patients, as they might gain information regarding~     their individual results regarding objective VA measures, contrast sensitivity (and their~     impact on reading ability). Furthermore, the results of the study could be beneficial for~     future patients due to, e.g., a better understanding of the disease, especially regarding~     factors which have an impact on their near vision ability and therefore their quality of~     life. The study could provide a basis to find and include outcome measures which are~     correlated better with quality of life than ETDRS distance VA for further AMD trials.~   "
9790|NCT03438656|"~     National data indicate over 650,000 children and adolescents are exposed to physical, sexual,~     or emotional abuse or physical or emotional neglect each year. Moreover, youth with a history~     of childhood maltreatment (CM) are at least twice as likely to develop depression and are at~     substantial risk for nonresponse to current best practice depression interventions (i.e.,~     cognitive behavioral therapy and antidepressants) compared to non-maltreated peers. Research~     suggests that CM increases risk for depression through disruptions in the positive valence~     system, such as reward processing, and Behavioral Activation (BA) may be an alternative~     depression intervention that targets these deficits. This study takes an innovative approach~     integrating neural, behavioral, and novel mobile technologies to measure longitudinal change~     in reward processing as a mechanism of BA intervention response among depressed adolescents~     with a history of CM. Specifically, depressed adolescents with a history of CM will complete~     pre- and post- BA intervention fMRI and behavioral measures of reward processing along with~     daily passive mobile monitoring of physical (steps) and social (amount of texts, calls,~     social media usage) activity to determine 1) how BA targets neural and behavioral reward~     processing and real-world behavioral engagement (Specific Aim 1), and 2) whether change in~     neural and behavioral reward processing predicts intervention response and maintenance~     (Specific Aim 2).~   "
9791|NCT03438643|"~     Extracorporeal photopheresis (ECP) is a cellular therapy indicated in the treatment of~     chronic GVHD (cGVHD). In this study protocol, patients suffering from inaugural cGVHD will be~     treated with the association of ECP and corticosteroid treatment. Treatment will start by an~     induction stage with 2 sessions of ECP per week until the 10th week followed by a maintenance~     stage including one session every other week until the 22th week. The objective of this study~     is to highlight the immunological mechanism of extracorporeal photopheresis treatment.~     Indeed, ECP is based on an immunomodulatory immunological effect and despite several~     hypotheses highlighted by different teams; clear mechanisms still need to be defined. This~     French multicenter study realize an immunological follow-up before and during treatment to~     elucidate the impact of ECP on immune system of responder patient.~   "
9792|NCT03438630|"~     Hip and knee osteoarthritis is one of the leading causes of global disability. There is no~     cure for the disease, but research and guidelines recommends that patients with~     osteoarthritis, early after the diagnosis, receive individually adapted physical exercises,~     information about their disease and about self-management and, if needed, recommendations on~     weight loss as a core treatment to prevent disability and impairment in health. This core~     treatment improves symptoms in osteoarthritis by reducing pain and increasing function, and~     have the potential to delay replacement surgery. In Sweden, core treatment has since 2008,~     been standardized in a supported self-management programme and evaluation and follow-ups are~     registered in the National Quality Register BOA (Better management of patients with~     OsteoArthritis). The course of deterioration in pain and physical functioning among different~     individuals with osteoarthritis is currently difficult to predict. Factors such as~     socioeconomic status and comorbidity contribute to progression of the disease, but are not~     fully established. There is a need for early identification of individuals who have a good~     prognosis with slow disease development and those that should be recommended joint~     replacement surgery in the future. Overriding aim of the study is to increase knowledge about~     the population who has received education and supervised exercises as a core treatment for~     hip and knee osteoarthritis and been registered in the BOA Register and to identify factors~     that can predict long-term outcome for this population.~   "
9793|NCT03438617|"~     This project will develop a combined model of the Shanghai Integration Model and peer~     support, implement and evaluate it in ten Community Health Centers in Shanghai, disseminate~     the resulting model across the 240 Community Health Centers in Shanghai, and, in~     collaboration with the Chinese Diabetes Society, across care providers throughout China.~   "
9794|NCT03438604|"~     A study to assess the effect of heat application on the delivery profile of Corplex™~     Donepezil Transdermal Delivery System (TDS)~   "
9795|NCT03438591|"~     trans-coronary sinus intraseptal pacing (cerclage pacing)~   "
9800|NCT03438526|"~     Delirium is a neurobehavioural syndrome that frequently develops in the postoperative and/or~     ICU setting. The incidence of elderly patients who develop delirium during hospital stay~     ranges from 11-82%. Delirium was first described more than half a century ago in the cardiac~     surgery population, where it was already discovered as a state that might be accompanied by~     serious complications such as prolonged ICU and hospital stay, reduced quality of life and~     increased mortality. Furthermore, the duration of delirium is associated with worse long-term~     cognitive function in the general ICU population. This long-term experience with delirium~     suggests a high socioeconomic liability and has been a focus of many studies. The~     aforementioned consequences of delirium are observed in all of three subtypes: hypoactive,~     hyperactive, and mixed. Pharmacological treatment options for hypoactive delirium are~     lacking. Since patients in hypoactive delirium suffer from disturbed circadian rhythm, the~     investigators suggest that the administration of melatonin as a promising possibility in~     these patients to shorten delirium duration and to lower its severity. Previous~     investigations confirmed loss of melatonin rhythm in patients that had developed delirium~     thus reasoning the study hypothesis.~      In this randomized study, the investigators aim to test the hypothesis that the reinstitution~     of a normal circadian rhythm by the administration of melatonin compared to placebo after~     diagnosis of hypoactive delirium, decreases the duration of delirium and reduces the~     transmission to a form of agitated delirium. The administration might have to be repeated~     several times to achieve resolution of delirium.~   "
9801|NCT03438513|"~     The coverage of the caregivers of patients reached of neurodegenerative disease becomes~     essential. The psychic, physical but also social impacts for the caregivers are widely~     documented in the literature just like the stress associated with this role, we speak then~     about burden of the caregivers. It seems that the caregivers set up little effective~     strategies of adaptation pulling fatal consequences on their well-being. He was shown in the~     literature, that a level of high stress is going to engender a decrease of mental flexibility~     and so entrainer a rigidity of adaptation.~      To decrease the burden of the caregivers, numerous interventions were proposed. The analysis~     of the literature highlights that these interventions are rarely developed from theoretical~     models pulling(entailing) a stream of techniques proposed to the caregivers but without~     precise objective. The most effective interventions concerning the coverage(care) of the~     burden of the caregivers are the ones which are targeted and structured, those who put the~     helper in active position and who have an effect on the subjective burden. The~     cognitive-behavioral therapy (TCC) would seem particularly effective.~      So, to modify the perception (collection) of the caregivers in front of cognitive,~     behavioral, functional modifications of their close friend(relation), to bring them to~     estimate positively their role and to favor the employment(use) of adaptive strategies turns~     out to be a privileged target of intervention to be used(employed) to improve the well-being~     of the caregivers and so decrease their burden.~      Considering this, an intervention based on the techniques of resolution of problems (TRP)~     could show itself very relevant as specific coverage (care). The works concerning the~     contribution of the TRP and the adaptation generally concerning situations of health showed~     that this type(chap) of intervention facilitated an adapted situational coping, but also~     increased generally the social, academic and professional performances.~      Various searches(researches) also showed that the resolution of problem is associated with~     indicators of adaptation at patients' nursing reached(affected) by Alzheimer's disease.~      So we propose to the family caregivers a coverage(care) based on the therapy of resolution of~     problems taking support on the model of Lazarus's stress and Folkman and according to the~     model stemming from works of D' Zurilla and Nezu.~      We make the hypothesis that this intervention is going to allow a decrease of the burden by~     allowing the caregivers to find a capacity to modulate their strategies to fit at best the~     evolutions of the clinical situation.~      The main objective of our study is to compare the efficiency of a coverage(care) based on the~     Therapy of Resolution of Problems to a group of word and to that proposed at the moment~     within the pole of gerontology in the decrease of the burden of the caregivers of patients~     reached(affected) by neurodegenerative disease in 12 months. Our secondary objectives will~     concern the evolution of the burden in 6 months and the evolution of the strategies of~     coping, the anxious, depressive symptomatology, the quality of life, the mental flexibility~     in 6 and 12 months.~      According to the data of the current literature, we expect a decrease of the psychological~     distress, an increase of the good(property) to be psychological. More specifically, by~     proposing an intervention targeted in particular at the management of the stress, the helper~     is going to acquire fitnesses which will have a long-lasting(sustainable) therapeutic effect.~      By associating techniques of psychoeducation with techniques of management of the stress we~     hope we can propose a type(chap) of intervention suited to the natural caregivers to favor~     the preservation at home.~   "
9802|NCT03438500|"~     The purpose of the study is to assess the feasibility of Cardiac Shock Wave Treatment in~     patients with anginal chest pain and evidence of abnormal myocardial perfusion under stress~     in the absence of significant stenoses of the epicardial coronary arteries.~   "
9803|NCT03438487|"~     The study is a population based prospective cohort study designed to collect data on~     pregnancy outcomes and events of interest among women immunized with the TIVc or QIVc vaccine~     during pregnancy.~   "
9804|NCT03438474|"~     The primary aim of this trial is to ascertain whether or not systematic pelvic and~     para-aortic lymphadenectomy (LNE) does have a significant impact on overall survival (OS) in~     patients with endometrial cancer (EC) FIGO Stages I or II and high risk of recurrence.~     Secondary aims will be to evaluate the effect of LNE on disease free survival (DFS) and~     quality of life, as well as the complications and side effects of LNE and the number of~     resected lymphnodes. 640 patients with histologically confirmed EC with high risk of~     recurrence (stage pT1b - pT2, all histological subtypes; pT1a, G3 endometrioid or serous or~     clear cell EC or carcinosarcomas) will be randomized. In Arm A, a total hysterectomy and~     bilateral salpingo-oophorectomy and in case of serous or clear cell EC additionally an~     omentectomy will be performed. In arm B in addition a systematic pelvic and para-aortic LNE~     up to the level of the left renal vein will be performed.~   "
9805|NCT03438461|"~     The purpose of this study is to assess and compare the pharmacokinetics (PK) and relative~     oral bioavailability of 3 oral tablet formulations of seltorexant in fasted and semi-fasted~     conditions.~   "
9806|NCT03438448|"~     Background: Despite preoperative screening, technical improvements and increased patient~     monitoring, perioperative myocardial infarction (PMI) remains the first cause of morbidity~     and mortality within 30 days after surgery. Moreover, the available evidence indicates~     worrying rise of risk in postoperative patients with only elevated troponins reflecting~     cardiac injury, but without a conventional clinical diagnosis of myocardial infarction~     according to current definition. Worldwide, annually approximately 300 million adults undergo~     major non cardiac surgery and 10 million of them are estimated to suffer a myocardial injury~     after non-cardiac surgery (MINS), defined as a prognostically relevant increase of a troponin~     T peak of 0.03 ng/ml or greater. Many of the patients with MINS does not fulfill the~     universal definition of myocardial infarction, rarely experience ischemic symptoms and their~     prognosis is very poor (1 out of 10 die at 30 days).Troponin levels needed to be monitored in~     order to MINS diagnose and high sensitive cardiac troponin T assays are currently the most~     frequently used.~      Methods: Patients with high cardiovascular risk undergoing major non-cardiac surgery will be~     selected from the daily surgical program during a two years period Three determinations of~     hs-cTnT for each patient will be obtained. The proportion of patients with MINS and pre- and~     post-operative thresholds of hs-cTnT that would be prognostically relevant will be~     determined. The cost-effectiveness analysis of hs-cTnT monitoring compared with usual care~     will be undertaken. Finally using computed tomography angiography (CTA) and cardiac magnetic~     resonance imaging (MRI) pathophysiology of MINS will be determined, whether is due to plaque~     rupture, supply-demand mismatch, non-ischemic cardiac cause or non-cardiac cause.~      Discussion: The study will evaluate the feasibility and impact of implementing the hs-cTnT~     monitoring program in the Hospital de la Santa Creu i Sant Pau of Barcelona, as well as its~     cost-effectiveness. Moreover, this is the first study which will determine pre and~     postoperative thresholds of hs-cTnT and with minimally invasive diagnostic tools will~     evaluate potential mechanisms involved in perioperative ischemic events.~   "
9807|NCT03438435|"~     Patients undergoing ERCP procedure with biliary stricture will have epithelial mucosa labeled~     with QRH-882260 fluorescence peptide that binds to EGFR. A custom mini-cholangioscope will be~     used to image the luminal surfaces of the biliary duct that are exposed to the fluorescence~     peptide. The images will be recorded and analyzed for relative fluorescence pattern and~     intensity and correlated to patient diagnosis and clinical outcomes.~   "
9808|NCT03438422|"~     Study with food supplement to assess the eficacy of pollen extract on Urinary Incontinence~   "
9809|NCT03438409|"~     The purpose of this study is to investigate changes in response to robotic gait training in~     individuals with a traumatic brain injury.~   "
9810|NCT03438396|"~     A Single arm, Multicenter, International Trial of Tisotumab Vedotin (HuMax®-TF-ADC) in~     Previously Treated, Recurrent or Metastatic Cervical Cancer.~   "
9811|NCT03438383|"~     The effect of Bi-PAP at individualized pressures on the postoperative pulmonary recovery of~     morbidly obese patients (MOP) undergoing open bariatric surgery (OBS) and possible placebo~     device-related effects (sham-Bi-PAP) were investigated.~   "
9823|NCT03438227|"~     Iron deficiency is the most common cause of anemia in pregnancy worldwide, and, when severe,~     can have serious consequences for mothers and babies. While treatment of iron-deficiency~     anemia with iron supplementation is recommended, treatment strategies remain controversial:~     the American College of Obstetrics and Gynecology recommends oral iron supplementation with~     parental iron reserved for the rare patient who cannot tolerate or will not take oral iron,~     while UK professional organizations recommend a more liberal use of parenteral iron. The~     reason for these disparate recommendations is that few high-quality studies comparing oral to~     parenteral iron have been conducted in developed countries, and the potential impact of~     parental iron treatment on obstetric and perinatal outcomes remains unclear. We propose the~     first randomized-controlled trial in the United States describing the effectiveness and~     safety of treating pregnant women with iron-deficiency anemia with a protocol including~     parenteral iron compared with a protocol based on oral iron.~   "
9812|NCT03438370|"~     The aim of this study is to evalulate the effectiveness and cost-effectiveness of three~     models of ART provision for stable ART patients. The objectives are to measure patient~     retention, virological suppression, provider and patient costs, cost-effectiveness, and~     patient acceptability amongst stable patients who receive ART at intervals of three and six~     months within community distribution models, and to compare these to patients who receive ART~     directly from the clinic at three month intervals.~      Methods~      A prospective, parallel, cluster-randomized non-inferiority trial with three study arms will~     be conducted. 30 Clusters (sites) will be randomized in strata according to geographic~     location (urban and rural) to the 3 study arms as follows:~        -  Control arm: sites at which patients will receive three monthly ART supply at the~          facility (arm 3MF).~        -  Intervention arm 1: sites at which patients will receive three monthly ART supply in~          CAGs (arm 3MC)~        -  Intervention arm 2: sites at which patients will receive six monthly ART supply in the~          community by a healthcare worker (arm 6MCD).~      The study population will consist of stable, HIV-infected adults who have received first-line~     ART for at least six months, who have a viral load <1000 copies/ml at baseline, and who~     provide informed consent for inclusion in the study. An average of 192 participants from each~     study site will be included, with a total sample size of approximately 5760 participants.~      The primary outcome is retention in care defined as the proportion of patients remaining in~     care 12 months after study enrolment, with the hypothesis that patient retention within the~     intervention arms will be non-inferior compared to the control arm. Retention in care will~     also be compared between the three arms after 24 months.~      The secondary outcomes are:~        -  Viral suppression: defined as the proportion of patients with virological suppression~          (<1000 copies/ml) 12 and 24 months after study enrolment;~        -  Cost of providing ART: defined as the cost per patient of providing ART in each of the~          three arms (from a provider perspective);~        -  Cost of retaining a patient: defined as the provider cost per patient retained and~          provider cost per patient retained with virological suppression in each of the three~          arms, and the incremental cost-effectiveness ratio for the comparative arms.~   "
9813|NCT03438357|"~     Using an automatic software tool, Pixyl.Neuro, to conduct a retrospective analysis (detection~     of lesions + segmentation of images + tracking over time) of cerebral MRI images acquired~     during a prospective study of patients presenting with clinically isolated syndrome, and~     comparing the results against manual analysis.~   "
9814|NCT03438344|"~     This randomized phase II trial studies how well multi-peptide cytomegalovirus (CMV)-modified~     vaccinia Ankara vaccine works in reducing CMV related complications in patients with blood~     cancer who are undergoing donor stem cell transplant. Vaccines made from a gene-modified~     virus may help the body build an effective immune response to kill cancer cells.~   "
9815|NCT03438331|"~     Major depressive disorder (MDD) is among the most common psychiatric disorders among~     adolescents, and is associated with considerable psychosocial and functional impairments and~     an elevated risk of suicidal behaviour and completed suicide. Meanwhile, sleep disturbance,~     particularly insomnia, is among the most prevalent and prominent presenting complaints in~     adolescents with depression. Despite its high prevalence, insomnia often remains overlooked~     and under-treated in clinical practice. However, growing evidence suggests an intricate~     relationship between insomnia and depression, which has become an area in need of further~     focused attention. This project will involve a randomised controlled trial proposed to~     examine whether insomnia treatment confers additional benefit to depression treatment in~     adolescents with comorbid depression and insomnia, for improving sleep and depressive~     symptoms, and other clinical and daytime symptoms as well as overall functional improvement~     in both the short and long term. Eligible adolescent participants will be randomised to~     either intervention (8-week group Cognitive Behavioural Therapy for Insomnia, CBT-I, or~     8-week group Cognitive Behavioural Therapy for Depression, CBT-D) or waiting-list control~     condition. Assessments will be conducted at pre-treatment (week 0), during the treatment~     (week 2, 4, 6) and post-treatment (week 8/at the conclusion of the last group session). The~     two active treatment groups will be additionally followed up at posttreatment one-month and~     six-month.~   "
9816|NCT03438318|"~     This is a multicenter, open-label, Phase 1b study of CMP-001 administered IT and~     subcutaneously (SC) in combination with atezolizumab with or without low-level radiation~     therapy in subjects with advanced non small cell lung cancer (NSCLC).~   "
9817|NCT03438305|"~     Background :An important risk factor for aspiration is gastric volume, determined in large~     part by gastric emptying. Unfortunately, measuring gastric volume over time is not easy, and~     scintigraphy has remained the gold standard technique for many years. Ultrasound has~     progressively emerged as a useful substitute due to its reduced cost and ease of performance~     Objectives:Assess whether ultrasonographic measurement of antral cross sectional area (CSA)~     can be used reliably for the diagnosis of risk stomach which defined by a gastric content~     volume at risk of clinical consequences for pulmonary aspiration (i.e., presence of solid~     particles and/or gastric fluid volume >1.5 ml/kg) during the preoperative period in~     longstanding diabetic patients.~      Study population :~        -  -Longstanding diabetic patients (group D)~        -  -Non diabetic patients (group N) Study Design : Prospective observational study This~          study will be conducted at Kasr alainy Hospital; Faculty of Medicine, Cairo~          University.Patients scheduled for elective operations need General Anesthesia (GA) with~          endotracheal intubation in theatre of general surgery Preoperative ultrasound to assess~          gastric residual volume then general anesthesia induction will be Modified~          Rapid-sequence Induction as follow; Group (D)/(N) : propofol 2-3mg/kg and fentanyl 1~          µg/Kg followed by Rocuronium 0.6-1.2 mg/kg.~      Suction of Gastric Contents by Nasogastric tube (18 french) will be inserted First set of~     analysis will be comparing preoperative US findings in 2 groups.~      Second set of analysis will be finding correlation between US findings and suction volume in~     two groups.~      Outcome parameters: To assess the residual gastric volume in longstanding diabetic patients~     compared to non diabetic patients.~      Sample Size ; was calculated as 48 patients (24) in each group.~   "
9818|NCT03438292|"~     Berberine from medicinal plants has therapeutic activities against multiple chronic diseases.~     But its absorption rate is very low. The objective of this study is to test if adding TPGS (a~     water-soluble form of vitamin E) as an emulsifier enhance the absorption of berberine in~     human.~   "
9819|NCT03438279|"~     This study will review published trial literature and documents for Overall Survival (OS) to~     evaluate the association between the hazard of death and each baseline variable.~   "
9820|NCT03438266|"~     The objective of this study is to evaluate the safety and effectiveness of JUVÉDERM VOLUMA XC~     (hereafter VOLUMA XC) injectable gel using cannula in subjects seeking correction of~     age-related volume deficit in the mid-face.~   "
9821|NCT03438253|"~     Penile engorgement during intraoperative period is of rare occurrence however when do~     happens, leads to difficulty in performing and even cancellation of elective urogenital~     surgery. The mechanism behind intraoperative penile engorgement is complex and involves~     various factors. One common myth is that penile engorgement occurs only during spinal~     anaesthesia and not in general anaesthesia. In this study we intend to report the incidence~     and management of intraoperative penile engorgement in pediatric patients undergoing~     urogenital operations under spinal anesthesia with/without sedation over a period of one~     year. The pathophysiology and role of common contributing factors leading to intraoperative~     penile engorgement are also discussed.~   "
9822|NCT03438240|"~     The purpose of this study is to compare addition of dexmedetomidine or fentanyl to~     bupivacaine for epidural analgesia in combination with general anesthesia in elective lumbar~     spine operations as regard hemodynamic stability, postoperative pain control and adverse~     effects.~   "
12014|NCT03409562|"~     The purpose of the present study is to evaluate whether the addition of two pain~     neurophysiology education sessions to motor control training may result in an improvement of~     the outcome measures of pain and disability, compared to motor control training alone.~   "
9824|NCT03438214|"~     This is a randomized, controlled multicenter clinical trial. The purpose of this study is to~     compare the continuous infusion of vancomycin with intermittent infusion regarding the~     effectiveness to reach the target serum level and the relationship between infusion type and~     nephrotoxicity in critically ill patients.~   "
9825|NCT03438201|"~     This is a Randomized Controlled Trial . The purpose of this study is to assess the hypothesis~     that whether a high protein diet combined with a physical activity protocol in surgical~     cancer patients admitted to the ICU in the post operative period is associated with better~     physical function at the hospital discharge as well as a better quality of life.~   "
9826|NCT03438188|"~     The purpose of this research study is to better understand why people gain weight when they~     quit smoking by examining food intake and changes in brain activity in smokers when they are~     smoking as usual compared to when they have been deprived of cigarettes (i.e., have not~     smoked for 4 days) as compared to a non-smoker control group.~   "
9827|NCT03438175|"~     The admission of a loved one in an ICU is a hard experience for family members. They~     frequently feel fear and grief, develop anxiety and depression symptoms, or even show some~     behaviors as this event was a real traumatic one, like hyper-arousal, avoidance and intrusion~     in the daily life.To improve the communication between them and the ICU staff members, and to~     meet their needs in terms of medical comprehension and emotional legitimization, a specific~     website was built, and a brochure was printed to make them welcomed in the ICU; moreover, a~     series of poster was prepared for the family waiting room outside the ICU. These instruments~     appeared able to improve the correctness of prognosis comprehension and to decrease the~     post-traumatic stress symptoms in a multicenter study involving Italian ICUs. The proposal of~     the present study is to verify on a larger scale if these instruments can really ameliorate~     the empathic communication among staff members, without increase in workload, and to make~     less traumatic, for the family members, their experience during and after the ICU stay.~   "
9828|NCT03438162|"~     Type 2 diabetes mellitus (T2DM) is a chronic progressive disease that affects more than 400~     million people worldwide. There are a few studies evaluating ADRs in diabetics. Many patients~     experience ADRs soon after hospital discharge which can be attributed to the changes in the~     pharmacotherapy during hospitalization. Education and counseling of diabetic patients has~     been shown to improve medication adherence and clinical outcomes. Studies that included~     medical patients revealed that education can significantly reduce risk of ADRs after hospital~     discharge. Pharmacotherapeutic education is a part of comprehensive education of diabetics~     that is focused on a proper use of medications, prevention and early detection of ADRs.~   "
9829|NCT03438149|"~     Obstructive sleep apnea (OSA) is independently associated with cardiovascular diseases,~     including myocardial infarction and stroke. OSA may promote atherosclerosis risk factors such~     as hypertension, diabetes and dyslipidemia and may have direct proatherogenic effects on the~     vascular wall. A growing number of studies have recently focused on the role of~     microparticles (MPs) in the atherogenic process. Case-control studies have shown that~     platelet-, endothelial- and leukocyte-derived MP levels are increased in OSA and that~     leukocyte-derived MP are released during the night in OSA. Furthermore, experimental evidence~     shows that MPs from OSA patients induce endothelial dysfunction.~      The objective of this prospective study is to evaluate the impact of increased levels of~     leukocyte derived MPs on the cardiovascular outcomes in patients with prevalent~     cardiovascular diseases investigated for OSA.~   "
9830|NCT03438136|"~     This study evaluates the feasibility of enrolling and retaining older adults in a 15-week~     intervention that will implement six factors from early childhood experiences: individualized~     scaffolding (having a responsive teacher), forgiving environment (allowing the learner to~     make and learn from mistakes), growth mindset (believing that abilities can develop with~     effort), open-minded learning (exploring new experiences), serious commitment to learning~     (adopting a learning lifestyle), and learning multiple skills simultaneously. These six~     factors will be implemented via concurrent classes at the UCR Extension center (OSHER~     Lifelong Learning Institute).~   "
9831|NCT03438123|"~     This study evaluates SPECT image data acquired from Spectrum Dynamics' multi-purpose CZT~     SPECT camera. All subjects will undergo routine clinical Anger SPECT imaging and an~     additional SPECT acquisition on the CZT SPECT camera. The quality of images from each device~     will be compared.~   "
9832|NCT03438110|"~     Preterm birth is a major cause of child mortality and morbidity, most of which occurs in~     south-east Asia and sub-Saharan Africa. To date few neonatal cause of death studies,~     especially in low- and middle-income countries have determined the specific causes of preterm~     death, instead attributing all neonatal deaths of infants born at less than 37 weeks to~     prematurity. Infections are responsible for a large proportion of these deaths but because of~     complexity and costs associated with testing, little is known about the prevalence of~     infection-related deaths in preterm infants or the specific pathogens associated with~     mortality.~      The primary objective of this study is to determine the cause of deaths among preterm births~     and stillbirths. Secondary outcomes include determining the specific pathogens responsible~     for infection-related deaths, potential preventability of these deaths and interventions~     which may reduce mortality. One site in India and one in Pakistan will include a total sample~     size of 700 (350 stillbirths and 350 preterm neonatal deaths) for 1,400 cases to be included~     in the cause of death analyses. All women who deliver a preterm birth or a stillbirth at the~     study hospitals will be eligible for inclusion. Among those who consent, an obstetric~     history, clinical obstetric and (if applicable) neonatal care will be collected as well as~     research investigations including ultrasound, x-ray, microbiology and minimally invasive~     tissue sampling and autopsy will be collected.~      This study will align with other efforts to determine cause of death among infants and~     children and ultimately the results will inform future interventions to reduce neonatal~     mortality and stillbirth. The researchers emphasize that this study, with its focus on~     preterm neonatal mortality and stillbirth, will provide information not available elsewhere.~   "
9833|NCT03438097|"~     The objective of this study is to survey the type and the amount of non-resuscitation fluids~     that patients with septic shock receives during their first 5 days of ICU admission.~   "
9834|NCT03438084|"~     The purpose of this study is to investigate whether there are differences in postprandial~     cardiometabolic metabolic indices following interesterified fats used commercially versus~     application appropriate non- interesterifed alternative fat.~   "
9835|NCT03438071|"~     The aim of the study is to test the effect of daily videoconference updates between parents~     of preterm newborns and health care providers which also offer them the possibility of seeing~     their child on the parental stress in a neonatal intensive care unit (NICU).~   "
9844|NCT03437954|"~     This research is being done because it is not known which dietary recommendations are best to~     help patients recover after a tonsillectomy and/or adenoidectomy. The purpose of this study~     is to determine how diet after tonsil/adenoid surgery affects bleeding, pain, and oral~     intake.~   "
9836|NCT03438058|"~     This project will involve a systematic literature review and meta-analysis of studies~     assessing the impact of complement-activating anti-Human Leukocyte Antigen (HLA) donor~     specific antibodies (DSA) on the allograft survival rate and on the rejection rate.~      This meta-analysis will assess the role of complement activating anti-HLA DSAs across the~     entire transplant field including kidney, liver, lung and heart transplant recipient's~     studies.~   "
9837|NCT03438045|"~     This feasibility and acceptability study will be conducted at 3 community outreach centers~     serving an urban, low-income Chinese population. The study will evaluate the feasibility and~     acceptability of implementing a partnered intervention to improve the oral and general health~     of low-income, urban Chinese American adults and of using remote data entry into an~     electronic health record (EHR). The research staff will survey a sample of Chinese American~     patients screened at each center about their satisfaction with the partnered intervention and~     about their oral health behaviors. An additional sample selected from providers [dentists and~     community health workers (CHW)], research staff, New York University (NYU) administrators,~     site directors, and community advisory board (CAB) members will participate in structured~     interviews about the partnered intervention. The remote EHR evaluation will include group~     adaptation sessions and workflow analyses via multiple recorded sessions with research staff,~     NYU administrators, outreach site directors, and providers (dentists and CHWs). The study~     will also model knowledge held by these non-patient participants (including CAB members) to~     evaluate and enhance the partnered intervention during and/or after the feasibility and~     acceptability study for use in future implementations.~   "
9838|NCT03438032|"~     Alveolar macrophages isolated from bronchoalveolar lavage (BAL) fluid from SSc patients with~     clinically significant lung fibrosis will be studied at baseline and at 6 months after~     enrollment to assess longitudinally the presence and persistence of an emergent, pro-fibrotic~     alveolar macrophage population, using single cell RNA-Seq technology to measure the~     individual transcriptome from each cell.~   "
9839|NCT03438019|"~     This proposal aims at evaluating an inspiratory muscle training (IMT) method not previously~     tested in COPD called the Test of Incremental Respiratory Endurance (TIRE). As a training~     method, TIRE promises to provide further benefits over standard IMT because it allows the~     user to adjust training loads as progress is made, adjusts the training based on day-to-day~     variations commonly noted in COPD, and provides a graphic representation of the inspiratory~     effort throughout all inspiration with real-time biofeedback in order to coach the user in~     performing the exercises. The TIRE device can also be used as an assessment tool, not only to~     measure the commonly used measure of inspiratory muscle strength Maximal Inspiratory Pressure~     (MIP), but also measuring the MIP variation generated throughout a maximal sustained~     inspiration. In this way, TIRE integrates MIP over the inspiratory duration (ID), providing a~     novel derivative measure called the sustained maximal inspiratory pressure or SMIP, that is~     likely a better surrogate of inspiratory muscle performance in COPD based upon preliminary~     data. The main goal of this trial is to fully evaluate the utility of TIRE as an IMT method~     in veterans with COPD. The investigators hypothesize that as a stand-alone therapy, TIRE~     training is superior to standard IMT in improving inspiratory muscle strength and endurance~     and in improving COPD-related clinical outcomes.~   "
9840|NCT03438006|"~     The purpose of this prospective, multi-centre, PMS cohort study is to monitor the safety of~     Cervarix, which is the first HPV vaccine licensed for use in China, to help prevent cervical~     cancer caused by HPV types 16 and 18. The vaccine was approved by China Food and Drug~     Administration (CFDA), in July 2016.~      As per Chinese Food and Drug Administration (CFDA) commitment, this study will collect data~     regarding the safety of the vaccine, related information on potential immune-mediated~     diseases (pIMDs); which are diseases that could affect the immune system, and the effect on~     pregnancy outcomes (POs) including birth defects in the newborn.~      Cervarix was approved for use in females between 9-25 years of age, for the prevention of~     cervical cancer, cervical intraepithelial neoplasia grade 1 (CIN1), cervical intraepithelial~     neoplasia grade 2, grade 3 (CIN 2/3) and adenocarcinoma in situ caused by high-risk human~     papillomavirus (HR-HPV) types 16 and 18.~      The exposed set (ES) will comprise of approximately 3000 subjects, who will be vaccinated~     with Cervarix, on a voluntary basis, as per standard practice. The study will collect~     information on any adverse event following immunisation, pIMDs, POs and congenital anomalies.~   "
9841|NCT03437993|"~     Adults who have attention deficit hyperactivity disorder (ADHD) suffer from significant~     occupational, academic and social problems, many of which are believed to be a result of~     problems with executive functioning. Executive functioning refers to a group of~     neuro-psychological functions which include sustained attention, working memory, verbal~     fluency, as well as motor and mental processing speed. Individuals with ADHD have been shown~     to have deficits in executive functioning independent of IQ, co-occurring psychiatric~     disorders, gender, and ADHD subtype. Recollect is an application (App) based working memory~     training video game where participants conduct 3-different adaptive working memory tasks. In~     each of these tasks participants are presented with a set of stimuli to be remembered while~     playing a simple platform game where they help navigate an astronaut across the screen and~     dodge obstacles. Recollect has been designed for all age groups to an interesting, fun and~     effective brain-training activity. The memory tasks included in the game have been~     independently shown to improve working memory in a manner that transfers to untrained tasks.~      The purpose of this study is to evaluate the effects of playing Recollect versus Tetris for~     20 minutes per day, 5 days per week over a 4 week period, on executive functioning deficits~     in individuals who have Adult ADHD.~   "
9842|NCT03437980|"~     Patient's safety and satisfaction are major concerns of anesthesiologists and obstetricians.~     According to evidence, guidelines and quality markers, regional anesthesia is preferred over~     general anesthesia in obstetric surgery. A high level of anxiety is present in obstetric~     patients preoperatively. Patients with high anxiety tend to prefer general anesthesia for~     cesarean section. The anxiety can be reduced variably by non-pharmacologic and pharmacologic~     methods. The evidence supports the benefits of procedural sedation for distressed, anxious~     pregnant women.~   "
9843|NCT03437967|"~     This study will examine the effect of LASER photobiomodulation therapy on pain and opioid~     pain medication weaning on patients who are undergoing opioid pain medication weaning.~   "
35992|NCT03095495|"~     The enrolled RSV-bronchiolitis patients will be randomized into two arms , the early HHHFNC~     group and the standard therapy group with rescue HHHFNC to study the efficacy of this~     treatment.~   "
9845|NCT03437941|"~     This is an open-label, Phase 1/2a dose escalation study with an expansion phase to evaluate~     the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD), and preliminary~     efficacy of CORT125281 in combination with enzalutamide in patients with metastatic~     castration-resistant prostate cancer (mCRPC) to identify a recommended dose (RD) for Phase 2~     studies.~   "
9846|NCT03437928|"~     The goal of the study is to address the unmet need of TRD patients by identifying brain~     networks critical for treating depression and to use next generation precision DBS with~     steering capability to engage these targeted networks. The study's goal will be achieved~     through 3 specific aims:~        1. Demonstrate device capability to selectively and predictably engage distinct brain~          networks~        2. Delineate depression-relevant networks and demonstrate behavioral changes with~          network-targeted stimulation~        3. Demonstrate that chronic DBS using steered, individualized targeting is feasible and~          safe for reducing depressive symptoms~   "
9847|NCT03437915|"~     Partial breast irradiation is typically performed after surgical removal of the tumor.~     Partial breast irradiation allows for focused radiation to the area from which the cancer was~     removed, sparing breast tissue from the potential bad effects of radiation compared to~     radiating the whole breast, which was the standard of care for many years. This study is~     evaluating the use of partial breast irradiation with NIBB performed before surgery instead~     of after surgery.This should allow researchers to target the cancer even more accurately and~     result in less normal breast tissue receiving radiation which may cause less side effects~     and/or a better cosmetic outcome.~      In this study partial breast treatment will be given with NIBB in 5 treatments over about 1~     week. Surgical removal of the tumor will then be performed between 4-12 weeks following~     radiation treatment. Researchers believe that participant's risk of complications from~     surgery will not be higher after getting these radiation treatments than it would have been~     if participants had surgery first, but that is one of the things researchers are studying.~   "
9848|NCT03437902|"~     The objective of this study is to investigate the effect ofRutin and Vitamin C combination in~     comparison with vitamin C alone on the oxidative and antioxidative status , insulin~     resistance and lipid profile in type 2 diabetic patients.~   "
9849|NCT03437889|"~     Pregnant women, with a Body Mass Index (BMI) greater than 30 kg/m2, who receive epidural~     analgesia/anesthesia for childbirth will have epidural catheter placement per our standard~     procedure, which includes using the gravity flow technique to confirm that the tip (aperture)~     of the epidural needle is indeed located within the epidural space. The study procedure will~     be to use a cold stimulus (ice) to assess the subjects for hypesthesia the dermatomes of the~     lower abdomen between 10 and 30 minutes after the epidural catheter is inserted. Hypesthesia~     to cold will be taken a sign of successful lumbar epidural block.~   "
9850|NCT03437876|"~     Chronic hepatitis B (CHB) is a common infectious disease affecting up to 2 billion people~     worldwide. Around 650 thousand people died of liver failure, cirrhosis and primary liver~     cancer caused by chronic hepatitis B every year. 3%-5% compensatory liver cirrhosis develop~     to decompensated cirrhosis and suffer from series symptoms such as fatigue, edema, portal~     hypertension, splenomegaly, hemorrhage, hepatic encephalopathy, hepatorenal syndrome and so~     on. Chronic hepatitis B is closely related to the imbalance of intestinal microbiota, and the~     intestinal microbiota of patients is significantly different from healthy people. The~     response of patients to hepatitis B virus can be influenced by reconstructing intestinal~     flora, while Intestinal microbiota transplantation(IMT) is a significant method to achieve~     it. In a previous study using IMT to treat HBeAg positive chronic hepatitis B patients~     combined with antiviral therapy, 80% of them has reached HBeAg clearance. The investigators~     propose a randomized trial of IMT in patients with HBV induced cirrhosis. Patients will be~     randomized to either control group or IMT group over a 12 months period.~   "
9851|NCT03437863|"~     Self-management of chronic illness can be highly demanding and people need to mobilize their~     personal strengths in order to live well with their condition. A mobile application was~     designed in collaboration with people with chronic illness and health care providers with the~     aims to support awareness of patients' strengths and patient-provider dialogues that include~     strengths. The aim of the present study is to evaluate with mixed methods the perceived~     usefulness and usability of the application and potential effects of the application on~     patients and patient-health care provider communication on strengths.~   "
9852|NCT03437850|"~     A traumatic spinal cord injury (TSCI) often causes an unprecedented change in functioning by~     altering bodily structure and function. More specifically, the direct consequences of TSCI to~     the motor, sensory and autonomic nervous system not only challenge an individual's~     independency but also the ability to make a positive adjustment to life after injury. In line~     with this, TSCI survivors often experience threats to their livelihood and becoming~     integrated members of society. Health systems therefore need to be ready to respond to the~     myriad of challenges following a TSCI by providing access to specialized and comprehensive~     services. The provision of specialized care in a time-sensitive manner has shown to be~     crucial for survival and recovery of functioning after a traumatic spinal cord injury (TSCI).~     However, little is known about the provision of TSCI care in different international~     contexts; information which is required for strengthening policy and practice.~   "
9853|NCT03437837|"~     Prognostic assessment after preoperative systemic therapy (PST) plays a vital role in breast~     cancer patients. The clinical-pathologic staging system incorporating estrogen receptor~     (ER)-negative disease and nuclear grade 3 tumor pathology (CPS+EG staging system) can~     effectively predict prognosis after PST. The Neo-Bioscore has been developed by the~     incorporation of the human epidermal growth factor receptor 2 (HER2) status into the CPS+EG~     staging system. But in a real world in China, the both staging systems had limits because of~     trastuzumab administration varied a lot in China from the United States. This retrospective~     study will validate CPS+EG and Neo-Bioscore system and explored a modified Neo-Bioscore~     system in multiple centers.~   "
9854|NCT03437824|"~     In this study, the investigators aim to assess if vitamin B12 treatment demonstrates a~     beneficial effect on voice performance. If so, they wish to examine the relationship between~     the vitamin B12 treatment and the study participant's general well-being.~   "
9912|NCT03437070|"~     This study seeks to determine if addition of trabectedin (T) to combination doxorubicin (D)~     and olaratumab (O), is feasible and tolerable with antitumor activity in metastatic or~     recurrent Leiomyosarcomas (LMS) patients who have limited therapeutic options.~   "
9855|NCT03437811|"~     Phase IV interventional study of adults (18 to 55) having a diagnosis of cystic fibrosis~     (mild, moderate or severe). The study is completely voluntary and is designed to measure~     participants use and the effectiveness of the device within the 510K indication of: airway~     clearance therapy when external manipulation of the thorax. The trial period shall be 30 days~     and include use of a FDA cleared pulse oximetry monitor (K131111), manual spirometer as well~     as completion of semi-weekly participant survey.~   "
9856|NCT03437798|"~     Despite significant improvement in treating periodontal disease (PD) and the identification~     of multiple risk factors, little is known about the specific contribution of genetics to PD~     pathogenesis. Several genomewide association studies (GWAS) of PD have been published, but~     only one reported locus has reached the threshold for genome-wide significance.~     Epidemiological studies and biological experiments established associations and suggested~     common pathogenetic pathways between PD and cardiovascular disease (CVD), diabetes (DM), and~     osteoporosis. The overall objective is to identify genetic loci for PD as a first step toward~     a better understanding of PD pathogenesis. In a preliminary study in the Women's Genome~     Health Study (WGHS), new-onset cases of PD were associated with a family history of~     myocardial infarction (MI). Further preliminary analyses presented shared phenotypic~     variation of PD/CVD, PD/DM, or PD/osteoporosis that could be accounted by the whole-genome~     genetic matrices. Several variants from the GWAS catalog of bone density and family history~     of MI were found correlated with PD in the WGHS. Based on these findings and the literature,~     the central hypothesis is that there are common pathogenetic links between PD and these other~     diseases and that GWAS using the comorbidity case definitions will help identify potential~     common loci.~   "
9857|NCT03437785|"~     To Evaluate the Efficacy and Safety of CKD-495~   "
9858|NCT03437772|"~     The investigators hypothesize that the mindfulness Cognitive Behavioral Therapy program will~     lead to a reduction in attention deficit and hyperactivity disorder symptoms, anxiety and~     depression, and improve self-confidence, emotional control, social integration and school~     results.~   "
9859|NCT03437759|"~     Purpose: To assess the safety and efficacy of mesenchymal stem cells (MSCs) and MSC-derived~     exosomes (MSC-Exos) for promoting healing of large and refractory macular holes (MHs).~      Hypothesis: MSC and MSC-Exo therapy may promote functional and anatomic recovery from MH.~     MSC-Exo therapy may be a useful and safe method for improving visual outcomes of surgery for~     refractory MHs.~   "
9860|NCT03437746|"~     Complications due to infection after colorectal surgery are frequent, affecting up to 25% of~     patients. Infection increases mortality, lengthens hospital stays, increases costs and~     decreases long term survival for cancer patients. Perioperative inflammation leads to~     hypercatabolism, denutrition and immunosuppression, all of which are associated to~     postoperative infection. Data from various sources suggests that modulating perioperative~     inflammatory response through the injection of corticosteroids would benefit the patient by~     reducing the number of postoperative complications after major surgery. Pre- or perioperative~     intravenous administration of a single corticosteroid flash is a means of modulating systemic~     inflammation that has been suggested for numerous types of surgeries, including pancreatic~     surgery. The objective of this study is to assess whether a preoperative single~     corticosteroid flash (methylprednisolone: 20 mg/kg IV at anesthetic induction) reduces the~     risk of serious complications after elective colorectal surgery.~   "
9861|NCT03437733|"~     This clinical investigation is a prospective, multicenter, single arm clinical evaluation~     utilizing the multi-electrode radiofrequency balloon catheter and the multi-electrode~     circular diagnostic catheter.~   "
9862|NCT03437720|"~     Primary Objective:~      - To evaluate the dose response relationship of SAR425899 compared to placebo on resolution~     of non-alcoholic steatohepatitis (NASH) with no worsening of fibrosis in diabetic and~     non-diabetic patients with histopathologically-confirmed NASH.~      Secondary Objectives:~        -  To assess the effect of SAR425899 on overall non-alcoholic fatty liver disease (NAFLD)~          activity score (NAS), individual components of NAS (steatosis, hepatocyte ballooning,~          and lobular inflammation), and fibrosis score.~        -  To assess to the effect of SAR425899 on MRI-PDFF (Magnetic Resonance Imaging-determined~          Proton Density Fat Fraction) derived parameters (total liver fat, liver volume, and~          fractional liver fat content).~        -  To assess the effect of SAR425889 on body weight and waist/hip circumference ratio.~        -  To assess SAR425899 pharmacokinetics.~        -  To assess safety and tolerability of SAR425899.~   "
9863|NCT03437707|"~     Primary aim of this prospective, randomized, double-blind, placebo-controlled clinical trial~     is to compare the analgesic effects of IV ibuprofen and paracetamol on postoperative pain,~     and secondary aim is the effects on morphine consumption and side effects of morphine in~     patients who underwent lumbar disc surgery with a single level unilateral hemi-laminectomy.~   "
9864|NCT03437694|"~     This is a clinical trial. The purpose of this clinical trial is to see if study participants~     have better health outcomes if their pharmacist has access to their medical records. The~     study will take place at a Walgreens community pharmacy in Dallas, Texas. The trial will~     enroll adult, African-Americans with HIV. They must also have diabetes, high blood pressure~     or both. Study participants will agree to have their medical records from all of their health~     providers released to UNTHSC. UNTHSC will provide the Walgreens pharmacist the medical~     records for half of the participants. Using the medical records, the pharmacist will provide~     'enhanced' patient counseling services to half of the participants. This enhanced service is~     called 'medication optimization'. For the half of participants that the pharmacist does not~     see the medical records, they will receive usual and customary patient counseling. Not seeing~     the medical records is considered standard of care. In both groups, the counseling frequency~     will be based on the participant's needs but the pharmacist will contact every participant to~     check on them at least every 90 days. These visits will happen for 2 years. The groups will~     be compared to see if those participants having medication optimization have better health~     than those getting routine patient counseling.~   "
9865|NCT03437681|"~     This study plans to learn more about how sleep loss impacts the way the body responds to~     sugar. This work will have important implications for development of treatments and~     countermeasures for people who are not able to get enough sleep for various reasons.~   "
12848|NCT03398668|"~     This study will evaluate the clinical performance and safety of a self administered abortive~     treatment for migraine headache using combined occipital and supraorbital transcutaneous~     nerve stimulator (Neurolief device, Relievion™).~   "
9866|NCT03437668|"~     To determine whether a standardized extract of Withania somnifera will reduce psychopathology~     scores (PANSS total score) in persons with schizophrenia. A secondary aim is to determine~     whether WSE reduces measures of positive and negative symptoms (PANSS subscales) and stress~     scores on the Perceived Stress Scale (PSS).~   "
9867|NCT03437655|"~     The aim of this study is through a randomized clinical trial, double blind, splithmouth,~     evaluate the success rate (retation rate and dental sensibility) of temporary direct~     restorations in vital teeth. The composition of the temporary direct restoration (based on~     Zinc-Oxide with Eugenol; and mineral trioxide aggregate). Data will be collected, tabulated~     and submitted to statistical analysis.~   "
9868|NCT03437642|"~     Psychological processes play a complex role in the pathophysiology of many diseases. However,~     the body and emotional perception of patients and the relationship between dreams and disease~     still need to be investigated.~      The investigators planned an observational and controlled research aimed at assessing some~     previously unaddressed baseline psychological characteristics and their changes at 1 and 5~     years after a short-term psychotherapy in carefully characterised patients with heart or~     oncologic diseases .~      The patients that will be enrolled are:~        -  50 patients ≤ 75 year old with acute myocardial infarction;~        -  30 patients ≤ 75 year old with Tako-Tsubo syndrome;~        -  50 women ≤ 75 year old, recently operated on breast cancer:~        -  90 control subjects of the same age and gender of the enrolled patients, without~          relevant pathologies during the last 10 years. Relevant pathologies are defined as those~          that required a hospitalisation or a long-lasting medical therapy.~      At the enrolment all the subjects will undergo a complete medical evaluation, and the~     following psychometric tests: Self-evaluation test, Social Support Questionnaire, Beck~     Depression Inventory II (BDI II), MacNew Heart Disease Health-Related Quality of Life~     Questionnaire, State-Trait Anxiety Inventory (STAI), State-Trait Anger Expression Inventory~     (STAXI 2).~      In two distinct following meetings, an open questionnaire exploring the body and emotional~     perception, and another exploring past and recent dreams, will be administered.~      The same evaluation will be done for the healthy subjects.~      After the initial evaluation, all the patients will be given the choice to start a short-term~     psychotherapy lasting 6 months on top of medical therapy or to continue classic medical~     therapy only. Healthy subjects will be not offered the possibility to follow psychotherapy.~      At first year of follow-up, the battery of psychometric test, and the two questionnaires~     exploring the body and emotional perception, and changes and characteristics of dreams during~     the psychotherapy, will be re-administered.~      The following data will be evaluated:~      Psychological characteristics at follow-up. Incidence of new relevant medical events Quality~     of life Relationship between psychological characteristics and health status, and quality of~     life~      At 5 year follow-up psychometric tests and the clinical data will be evaluated in all the~     groups.~   "
9869|NCT03437629|"~     The aim of this study is through a randomized clinical trial, double blind, split-mouth,~     evaluate the success rate (retention rate and dental sensibility) of temporary dental crown~     cemented on vital teeth. The composition of the cement (Based on calcium hydroxide; and based~     on mineral trioxide aggregate) will be evaluated. Data will be collected, tabulated and~     submitted to statistical analysis.~   "
9870|NCT03437616|"~     This study investigates the effectiveness of a Finnish Tulppa outpatient rehabilitation~     program. Tulppa is a group-based secondary prevention program for patients with vascular~     diseases. The program is developed by the Finnish Heart Association. The intervention is~     implemented at the local primary health care centers in 12 health districts in Finland.~      A longitudinal controlled study is used to investigate the effects of the intervention on~     participants' level of cardiovascular risk factors (e.g. lipids, blood pressure, body mass~     index), functional capacity (e.g. 6 minute walk test), life style as well as psychosocial~     factors (e.g. smoking, diet, physical activity, health-related quality of life and~     depression). The data will be collected at baseline (i.e. before the intervention), and 6 and~     12 months after the intervention started.~      The participants (n = 300) are patients diagnosed with coronary heart disease. The study~     group (n = 150) is recruited from participants of Tulppa rehabilitation in two health care~     districts (Pirkanmaa and Southern Karelia). The control group (n = 150) is recruited from two~     health care districts (Turku and Hyvinkää) that do not provide Tulppa rehabilitation.~   "
9871|NCT03437603|"~     To investigate the efficacy and safety for secondary poor graft function (PGF) post~     allogeneic hematopoietic stem cell transplantation (allo-HSCT). The primary objective is the~     hematologic response rate. Secondary objectives include: (1) incidence and severity of~     adverse events; (2) overall survival (OS), and disease-free survival(DFS).~   "
9872|NCT03437590|"~     The purpose of this study is to measure the blocking of [18F]-JNJ-64413739 uptake in the~     brain at the time to reach maximum plasma concentration (Tmax) and at 24 hours postdose of~     JNJ-55308942 following a single dose of JNJ-55308942; and to model the exposure/receptor~     interaction of JNJ-55308942.~   "
9873|NCT03437577|"~     The primary objective is to compare the effect of treatment with an immediate-release~     tacrolimus to an extended-release tacrolimus (i.e., Envarsus® XR) immunosuppressive regimen~     on cognitive and motor function in kidney transplant recipients~   "
9874|NCT03437564|"~     The purpose of this study is to evaluate the bioequivalence of a single oral administration~     of a Lu AA21004 20 mg tablet in comparison with two of Lu AA21004 10 mg tablets in Japanese~     healthy adult participants.~   "
9875|NCT03437551|"~     This study is designed to evaluate the prevalence of different stages of diabetic retinopathy~     and diabetic macular edema among patients suffering from type 1 diabetes (DM1) for 5 to 25~     years and have been treated with intensified insulin therapy aiming near-normal blood glucose~     levels for the whole duration of disease.~      Prevalence of different stages of diabetic retinopathy and diabetic macular edema is assessed~     using the modified Airlie House classification and the Early Treatment Diabetic Retinopathy~     Study (ETDRS) retinopathy severity scheme. Results of this study will provide the basis for~     designing further studies as well as staging and screening guidelines for diabetic~     retinopathy/diabetic macular edema.~   "
9876|NCT03437538|"~     The Medium Cut-Off dialysis (MCO) membrane has been developed to improve middle molecule~     removal compared to standard high-flux dialysis filters.~      The major aim of this study is to compare the reduction ratio and clearance of middle~     molecules, during a single hemodialysis session with MCO-filter, compared to~     hemodiafiltration (HDF) with standard high-flux filter.~      Secondary aims are to compare the reduction ratio and clearance of small and large molecules~     between the treatments.~   "
9877|NCT03437525|"~     This project will develop a combined model of the Shanghai Integration Model and peer support~     for diabetes self-management with a special focus on appropriate insulin use.~   "
9878|NCT03437512|"~     Research studies in stuttering have shown that activity patterns in certain brain areas~     differ in people who stutter compared to people who do not stutter when speaking. The purpose~     of this study is to investigate how mild, non-invasive brain stimulation applied~     consecutively for five days affects speech relevant brain areas, which may in turn affect~     speech fluency and speaking-related brain activity in people who stutter.~   "
9879|NCT03437499|"~     In this clinical trial the Investigators aimed to assess the Adrenomedullin (AM) release in~     urine and plasma in preterm infants undergoing Sustained Inflation or Positive Pressure~     Ventilation at birth to manage respiratory failure.~   "
9880|NCT03437486|"~     This a prospective, longitudinal study of first-degree family members of patients diagnosed~     with familial interstitial pneumonia (FIP). FIP is the familial form of idiopathic pulmonary~     fibrosis (IPF), which is defined as 2 or more bloodline relatives which have a diagnosis of~     idiopathic interstitial pneumonia (IIP). The most common form of idiopathic interstitial~     pneumonia in FIP families is IPF (approximately 70%). The inheritance pattern in FIP is~     consistent with autosomal dominant inheritance with incomplete penetrance. Therefore,~     individuals in this study have approximately 50% risk of carrying a disease-associated~     allele. The causative gene is currently only known approximately 20% of families. The main~     goal of this longitudinal study is to better establish the natural history of FIP and to~     identify risk factors for later development of symptomatic disease. The investigators' plan~     is to follow these at-risk individuals with yearly questionnaires and planned in person 5~     year follow-ups through age 70 or until they develop symptomatic FIP.~   "
9881|NCT03437473|"~     Multi-site, first-in-human study to assess safety and efficacy of an active implantable Vagus~     Nerve Stimulation (VNS) device in 15 adult patients with active moderate-to-severe rheumatoid~     arthritis who have had an incomplete response or intolerability to at least two different~     mechanisms of action.~   "
9882|NCT03437460|"~     Physical pain is a common but largely overlooked aspect of the lives of the poor. Not only~     does pain directly reduce life quality and happiness, it may also hamper cognitive function~     and, consequently, decision-making, productivity, and earnings. Workers with chronic pain may~     work fewer days, take longer breaks, and make less-considered choices regarding inputs; all~     outcomes that would reduce output and lead to greater impoverishment or impede the~     productivity and profitability of microenterprises and firms. The investigators will take the~     first steps in understanding the broader causal impact of physical pain on the cognitive and~     economic lives of the poor via a randomized controlled trial (RCT). 450 low-income women in~     Chennai, India, will be assigned to one of three treatment arms: 600 mg of over-the-counter~     pain medication, a placebo pill, or no medication. The research will quantify the causal~     impact of reduced pain on previously unstudied outcomes essential to escaping poverty~     including cognitive function, productivity, and earnings.~   "
9883|NCT03437447|"~     The purpose of this trial is to assess the bioequivalence (BE) of new 600 milligram (mg)~     Cisticid tablet (Test) versus 600 mg Biltricide tablets (Reference) at a dose of 1200 mg in~     healthy male subjects. Praziquantel (PZQ) is the active ingredient for Cisticid and~     Biltricide tablets.~   "
9884|NCT03437434|"~     This study evaluates the Visual Acuity and refraction of patients post 4-point Scleral~     fixation of BunnyLens (Intra Ocular Lens- IOL) with GoreTex sutures. All patients underwent~     secondary IOL implantation or IOL exchange during 2014-2017.~   "
9885|NCT03437421|"~     Vitamin D deficiency is recognized as a cardiovascular risk factor. Diabetic patients are of~     major risk for cardiovascular diseases and typically present with Vitamin D deficiencies.~     Myocardial function is altered in both type I and II diabetic patients but no data is today~     available on the effect of Vitamin D supplementation.~      The aim of the study will be to investigate myocardial function (by deformation imaging~     techniques) at rest and during low-dose dobutamine stress echocardiography in both type I and~     II diabetic patients. Within each diabetic population, myocardial function will be compared~     at baseline between the vitamin D deficient and non-deficient individuals. Furthermore, the~     investigators will study the effect of a 3 month supplementation in those with deficiencies.~   "
9886|NCT03437408|"~     There is an increasing evidence regarding the efficacy of a substrate-based ablation approach~     to ventricular tachycardia (VT). This approach involves identifying regions of scar and also~     areas displaying late potentials and fractionated activity. Automated mapping systems are now~     available which may be able to generate high density maps displaying regions containing both~     late potentials and ventricular scar. Such an automated approach has not been validated.~     Furthermore, most patients presenting for VT ablation have pacing devices in situ. It is not~     known how the pacing modality affect the substrate maps generated for these procedures. Once~     an area felt to be important to ablate has been identified, the next key step is to perform~     effective ablation. An algorithm has now been made available (Ablation index - Biosense~     Webster Inc.,) which in preclinical studies is an effective predictor of radiofrequency~     lesion depth. This algorithm has been studied extensively in the atrium but not in the~     ventricle. This study would also seek to collect ablation index data during ablation to~     assess the algorithm during ventricular ablation.~   "
9887|NCT03437395|"~     Breast cancer patients at Sentara RMH Hahn Cancer Center who are treated with accelerated~     partial breast irradiation will be monitored over a period of 10 years. From this group of~     patients, local and regional recurrence rates will be determined. Patients in the registry~     will also take part in assessments of cosmesis and quality of life.~   "
9888|NCT03437382|"~     In this multi-center, dose-finding study, patients with early stage hepatocellular carcinoma~     according to the Barcelona Clinic Liver Cancer (BCLC) staging system will be included to~     receive percutaneous radiofrequency ablation in combination with RFA with adjuvant segmental~     radioembolization.~   "
9889|NCT03437369|"~     This is a randomized 1:1 blinded study that evaluate in acute left heart failure-cardiogenic~     shock patients if ivabradine treatment can reduce pulmonary wedge pressure, without inducing~     a significant or relevant reduction in cardiac output or increasing the risk of arterial~     hypotension and with the benefit of allowing a faster titration of heart failure drugs.~   "
9890|NCT03437356|"~     In the POWDER 1 study, paroxysmal atrial fibrillation (AF) patients undergoing conventional~     contact force (CF)-guided PVI were investigated. Patients were randomized between continuing~     previously ineffective antiarrhythmic drug therapy (ADT) or stopping ADT at the end of the~     blanking period. This trial, showed an added value of ADT after ablation (in support of~     'hybrid rhythm control' as an alternative treatment strategy for AF in some patients).~      In the POWDER 2 trial, an analogue study in persistent AF patients will be performed. All~     patients will undergo ablation index (AI)- and IL distance (ILD)-guided PVI (just like in~     VISTAX trial) and continue previously ineffective ADT during the blanking period. 'PVI only'~     was chosen as the ablation strategy according to the STAR AF trial findings.~   "
10541|NCT03428828|"~     The purpose of this study is to determine the clinical efficacy of real-time functional~     magnetic resonance imaging neurofeedback (rtfMRI-nf) training to increase the amygdala's~     response to positive autobiographical memories in patients with depression who are considered~     treatment-resistant~   "
9891|NCT03437343|"~     This study used 3D reconstructions from the EOS biplanar radiographic imaging system to~     perform leg length measurements before and after THA (Total hip arthroplasty) on all included~     THA patients from 2015 to evaluate surgeon performance in restoring lower limb length after~     THA and the relationships between the quality of life, estimated by the HOOS score (Hip~     disability and osteoarthritis outcome score), and the anatomy of the new hip in standing~     position.~   "
9892|NCT03437330|"~     Empagliflozin effect on glucose toxicity in type 2 diabetes patients - a randomized,~     open-label, controlled, parallel group, exploratory study~   "
9893|NCT03437317|"~     The Perceptual Training Study is a series of studies performed with the purpose of~     identifying a potential avenue for treatment of mood disorders, particularly anxiety-based~     mood disorders. The underlying theme is that neural representations may be threat-oriented,~     and may also be generalized to non-threatening cues by means of similarity to threatening~     representations. These may result in anxiety symptoms from innocuous cues. The idea behind~     the perceptual training is to create a divorce between the threat representations and cues~     which should be considered non-threatening, enhancing perceptual acuity and potentially~     reducing anxiety symptoms.~   "
9894|NCT03437304|"~     This is a Phase I/II, randomised, multicentre, partially double-blind (group 1, 2, 4 and 5),~     parallel-group study designed to primarily evaluate the safety, tolerability and immune~     response in older adults (age 50 to 75 years) following Immunose™ FLU vaccination at 5 sites~     in Sweden. A total of 300 subjects will be randomised to 1 of 7 treatment groups. The~     hypothesis is that Immunose™ FLU is safe and tolerable and will increase the~     influenza-specific mucosal immune response in older adults.~   "
9895|NCT03437291|"~     Objective:~      To compare between the role of Transabdominal ultrasound versus Transvaginal ultrasound in~     evaluation of placental invasion in cases of placenta previa anterior wall with previous~     uterine scar applying the unified ultrasonographic descriptors suggested by the European~     working group on abnormally invasive placenta EW-AIP' Also to evaluate the sensitivity and~     specificity of each criterion by comparing them with the final outcome of pregnancy Fifty~     pregnant women with persistent placenta previa (after 28 weeks' gestation) were prospectively~     enrolled into this study. Both transabdominal and transvaginal ultrasound were performed by~     two different operators who were blinded to the results of each other.~      the placenta was studied as regarding the exact loacalization and the unified descriptors~     were applied and evaluated by TAS and TVS.~      The ultrasound findings were analyzed with reference to the final diagnosis made during~     Cesarean delivery and histopathological examination~   "
9896|NCT03437278|"~     This clinical study is designed to evaluate the pharmacokinetics, safety and efficacy of~     ligelizumab in children from 12 to <18 years of age, with chronic spontaneous urticaria.~      The study will generate data to be analyzed in a separate modelling and simulation study with~     the objective of i) estimating the relative potency of ligelizumab in adolescent patients~     compared with adults and ii) proposing a posology for the future treatment of adolescent~     patients.~      The patient population will be treated with ligelizumab as an add-on therapy to approved~     doses of H1- antihistamines following the guideline on treatment of CSU .~      The study consists of 3 distinct study periods: Screening period (up to 4 weeks) Treat~     period: Day 1 patients are randomized into one of the three treatment arms in 1:2:1 fashion~     to ligelizumab high dose q4w vs. ligelizumab low dose q4w vs. placebo. During the 24 weeks of~     treatment, doses are administered on Day 1 then 4, 8, 12, 16, and 20 weeks after~     randomization. Subjects randomized to placebo will receive placebo on Day 1, Weeks 4 and 8;~     thereafter they will receive ligelizumab (high dose) at Weeks 12, 16 and 20 such that the~     same number of patients will, by the end of the study, receive the high dose as the low dose.~     Safety is assessed every 4 weeks; efficacy is primarily assessed using daily itch and hives~     scores summed into the weekly UAS7. The treatment period (24 weeks) is followed by a~     follow-up period of 16 weeks to a maximum of Week 40.~   "
9897|NCT03437265|"~     This study characterises the pharmacokinetic (PK) profile of the active ingredients of~     NER1006 and their related substances/metabolites. Subjects will receive NER1006.~   "
9898|NCT03437252|"~     Patients who are suffering from COPD had a decreased level of physical activity which is~     consequentially related to another acute exacerbation event. In this study, we selected~     patients from those who were admitted for acute exacerbation of COPD, evaluated physical~     activity by accelerometer (wearable multisensory armband devices) to find out the correlation~     between physical activity in COPD acute exacerbation patients.~   "
9899|NCT03437239|"~     A randomized controlled pilot study evaluating the effect of occlusion training on bone~     density and function of the upper extremity following a biceps tenodesis.~   "
9900|NCT03437226|"~     Repetitive levosimendan infusions for patients with advanced chronic heart failure (LeoDOR) A~     randomised, double-blind, placebo-controlled multicentre study with parallel group design.~      Mortality and rehospitalisation rates are high in the vulnerable phase following heart~     failure hospitalisation. Previous studies suggest that these events can be reduced by repeat~     infusions of levosimendan in patients with advanced heart failure.~   "
9901|NCT03437213|"~     General anesthesia has an important effect on inflammatory cytokines. Inhalational agents as~     isoflurane and sevoflurane attenuate immune function expressed by neutrophil~     chemoattractant-1 as well as inflammatory enzyme and also they reduce inflammatory cascade.~     Total intravenous anesthesia (TIVA) based on using propofol suppresses the inflammatory~     response caused by surgery to a greater extent because Propofol affects the balance between~     pro-inflammatory and anti-inflammatory cytokines, increasing production of the~     anti-inflammatory cytokine IL-10 and at the same time reducing the increase of IL-6 during~     the perioperative period. It also alters expression of nitric oxide and inhibits neutrophil~     function. TIVA has many advantages such as; fewer side effects, earlier discharge, better~     patient satisfaction, faster recovery, less nausea and vomiting and reduced muscle relaxant~     requirements. Paravertebral block has an important role in the inflammatory and immune~     response. The paravertebral block can decrease perioperative inflammation and prevent immune~     suppression. Also, it can attenuate the cytokine response and reduce acute stress response~     caused by surgery. Decrease inflammation processes, improve surgery result, limit the~     duration of hospital stay, decrease post-operative fatigue and reduce postoperative~     complications.~   "
12849|NCT03398655|"~     The purpose of this phase 3, randomized, multicenter study is to compare VB-111 plus~     paclitaxel to paclitaxel in adult patients with Recurrent Platinum-Resistant Ovarian Cancer.~   "
9902|NCT03437200|"~     The main objective of the trial is to assess the feasibility and the safety of the addition~     of immunotherapy with PD-1 antibody nivolumab +/- CTLA-4 antibody ipilimumab to concomitant~     chemoradiation therapy (CRT) in inoperable patients with early or locally advanced~     oesophageal cancer and to select the more promising experimental arm among the two possible~     combinations in terms of activity (based on progression free survival (PFS) at 12 months~     according to RECIST 1.1) for further evaluation in a phase III trial.~      The secondary objectives will aim to evaluate progression-free survival, failure-free~     survival and overall survival and pattern of progression (including incidence of distance~     metastasis).~   "
9903|NCT03437187|"~     The enhanced recovery after surgery and laparoscopic approach is essential after day-case~     surgery. The patients want to go home early without pain and nausea, and the hospitals need~     the post-operative capacity for more patients. Many patients have pains, nausea and vomiting~     postoperatively. Postoperative pain is an expected but undesirable effect after an operation.~     The aim of the study is to find out if a bilateral quadratus lumborum block has a beneficial~     effect after a cholecystectomy.~   "
9904|NCT03437174|"~     Long-term conventional treatment of chronic hypoparathyroidism does not fully restore calcium~     homeostasis leading to increased morbidity, emergency events and reduced subjective health~     status. To further investigate general morbidity, hypocalcemic events, subjective and daily~     life performance in patients with chronic hypoparathyroidism a disease specific~     questionnaire, as well as the SF-36 are handed out.~   "
9905|NCT03437161|"~     This phase II trial studies how well deep inspiratory breath hold or prone breast radiation~     therapy works in reducing cardiac dose in patients with breast cancer or ductal carcinoma in~     situ. Deep inspiratory breath hold is a technique that involves a patient holding their~     breath during radiation to move the heart away from the breast to minimize radiation to the~     heart. Prone breast radiation therapy is a technique in which a patient receives treatment~     face-down to minimize the radiation to the rest of the body, including the heart and lungs.~     Comparing deep inspiratory breath hold to prone breast radiation therapy may help doctors~     improve radiation to the target while reducing radiation to healthy tissues surrounding the~     target.~   "
9906|NCT03437148|"~     Shunt quantification in atrial septal defect (ASD) is estimated by Echocardiography-Doppler,~     with the pulmonary-to-systemic blood flow ratio: Qp/Qs. Higher is the ratio, more important~     is the shunt, and the consequence on right ventricular function. A value higher than 1.5 is~     one of the criteria for percutaneous closure of Secundum ASD. Maatouk and al. have~     demonstrated that a shunt fraction (Qp/Qs) over 3 is a predictive factor of an incomplete~     reversibility of the right ventricular remodeling [1]. Even if the accuracy of Doppler~     echocardiography is admitted for Qp/Qs measurement, there is still some technical~     difficulties. Thus, the right cardiac catheterization for O2 consumption measurement by the~     direct Fick method is used. The major inconvenient is the potential risk of adverse effects.~     Non-invasive methods have been developed using physical properties (as the thoracic~     bioimpedance) or inert gas rebreathing technique. Thoracic Bioimpedance (TB) and inert gas~     rebreathing (IGR) techniques have been studies on healthy individual and different~     respiratory or cardiac diseases to evaluate the cardiac output (CO). TB and IGR measure the~     systemic and pulmonary blood flow respectively. Without shunt the pulmonary blood flow is~     equal to the systemic blood flow.~      Thus, Investigator suppose that combine the two techniques in disease with shunt, will allow~     a quantification of the shunt fraction Qp/Qs as accurate as with the gold standard technique~     (Fick method and Echocardiography Doppler).~      The purpose of the study is to evaluate the feasibility and the accuracy of the non-invasive~     measurement of the Qp/Qs ratio in secundum ASD using the IGR technique and the TB versus the~     two gold standard techniques: the Fick method and the Echocardiography-Doppler.~      The study hypothesizes that the values of Qp et Qs determined by IGR et TB respectively are~     in the same range of values that the one determined by gold standard techniques.~   "
9907|NCT03437135|"~     Diabetes is now the most common chronic disease, affecting nearly 6% of the population in~     Western populations. Diabetic neuropathy is a priori the most common and the most common~     specific complications of diabetes. It can of course touch the lower limbs, the vegetative~     nervous system as well as the cranial nerves. However, the association between hearing~     impairment and diabetes has always been controversial on the basis of conflicting literature~     data. Are auditory disorders an underestimated complication of diabetes? A meta-analysis made~     in 2013, examined the scientific literature between 1950 and 2011 and of the 3158 citations,~     only 13 articles were selected. This study found that hearing impairment in diabetic patients~     was 2.1 times more prevalent than in non-diabetic matched subjects. In addition, the age /~     aging factor is associated with the prevalence of hearing loss and diabetes. However, it also~     appears that the link between diabetes and hearing impairment is more pronounced among young~     people than older people. In order to document the influence of diabetic pathology on~     hearing, Investigator have set up a search audiological exploration platform within the~     department of Endocrinology-Diabetology of Clermont-Ferrand University Hospital. It will be~     proposed a hearing screening (duration 30 minutes) and a questionnaire to diabetic patients~     of the service. In the context of a positive screening, that is to say that one of the tests~     carried out reveals the presence of a hearing disorder, an in-depth assessment of the hearing~     will be carried out to better characterize the origin of the auditory disturbance (duration~     60-90 minutes). These different tests are based on the listening of sounds requiring or not~     the participation of patient. Thus, the results of the various tests will make it possible to~     classify the impairment of hearing in (1) peripheral impairment (dysfunction of certain cells~     of your ear involved in the amplification of sounds), and / or (2) in neural damage~     (dysfunction of your auditory nerve).~   "
9908|NCT03437122|"~     The increasing incidence of chronic respiratory diseases is a public health problem affecting~     hundreds of thousands of people around the world, including children. Directly exposed to~     atmospheric aerocontaminants (pollution, allergens), the respiratory tracts represent a~     complex ecosystem that involves different cells that develop complex interactions with the~     surrounding connective tissue but also with their rich immune environment and with the~     microbiota. Although a pathophysiological continuum is postulated between the nasal and~     bronchial airways in certain diseases, such as allergic diseases, we have identified broad~     gradients in gene expression between nasal and bronchial samples. This is why cellular~     variability throughout the respiratory tree needs to be studied in detail.~      The sequencing of RNAs specifically present in a particular cell, and its comparison with~     neighboring cells, allows us to document precise cellular contributions and intercellular~     relationships. Our project will establish protocols to stabilize airway swabs by brushing~     and/or biopsy, under conditions that will then allow the analysis of gene expression profiles~     at the single cell level (single cell RNA sequencing).~      The development of the single cell stabilisation and analysis protocol will first be~     carried out on primary respiratory epithelium cultures and then extended to respiratory~     specimens taken from healthy volunteers. Through sampling at several levels of the~     respiratory tree, variations in expression along the tracheobronchial axis will be fully~     documented. Finally, the interaction between the epithelial compartment and the immunological~     compartment will be studied by analyzing gene expression on a single cell in different~     physiopathological contexts.~   "
9909|NCT03437109|"~     The purpose of the study is to get data of prevalence of testosterone deficiency in patient~     with T2DM in Russian Federation~   "
9910|NCT03437096|"~     Association between venipuncture pain and postoperative pain~   "
9911|NCT03437083|"~     The primary objective of the study is to observe efficacy in terms of progression-free~     survival rate at 6 months in eribulin-treated breast cancer participants retrospectively.~   "
9913|NCT03437057|"~     Background/Rationale for the study:~      Lithiasis pathology is increasingly common because of the change in our lifestyle and our~     food. Thus, we hold a prevalence for urinary lithiasis 10% in France currently including 13%~     of the male population and 6% of the female population.~      The formation of urinary lithiasis is the result of a complex mechanism involving factors~     anatomical and infectious metabolics. They are classified according to their size, topography~     and composition.~      The treatment of urinary lithiasis has changed dramatically in recent years. The~     recommendations of the French Urology Association (AFU) for the management of kidney stones~     and ureteral of the adult of 2004 give a certain place to the treatment by lithotripsy (ECL).~      The ELC is indicated for the first purpose for lithiasis ureteral or renal lithiasis of less~     than 20 mm, whether or not associated with the setting up of a JJ probe. For kidney stones of~     more than 20 mm or complex or Coralliformes, the lithotripsy can be associated with treatment~     with percutaneous nephrolithotomy. In addition, the ECL is indicated in case of residual~     cholelithiasis 3 months after a first treatment whatsoever.~      It is found, as the main complication of the LEC, a risk of the appearance of Hematomas under~     capsular, peri-renal and intra-parenchymatous. Its prevalence is estimated to be between 6.2%~     and 13% according to studies.~      KARDEGIC 75, antiplatelet (PAA) is the lowest dosage of aspirin in the adult. The AMM of~     KARDEGIC recognises its indication in secondary prevention after a first myocardial or~     cerebral ischemic attack related to atherosclerosis. It entrains a reduction mortality and~     morbidity of cardiovascular causes.~      Kardegic is currently being stopped 5 to 7 days before the LEC. The interest of maintaining~     the KARDEGIC 75 is:~        -  A simplification of the management of patients under KARDEGIC 75 (No modification of~          Treatment to be implemented)~        -  Decreased cardiovascular risk (treatment maintained)~      Main objective:~      Evaluation of the proportion of renal hematoma during the production of Lithotripsy for renal~     lithiasis, on a 15-day scan, in patients under KARDEGIC 75mg not stopped~      Secondary objectives:~      Evaluation of the efficacy of treatment with lithotripsy (Stone free, fragments Minimal~     residuals) Evaluation of the proportion of hematuria macroscopic post lithotripsy in Patients~     under KARDEGIC 75 not stopped. Evaluate the rate of post-LEC complications requiring~     treatment, Analgesic, obstructive pyelonephritis.~      Evaluate post-LEC pain due to hematoma or lithiasis migration Evaluation of the evolution of~     renal function post session of Lithotripsy in the patients under KARDEGIC 75 not stopped.~      Type of Study: Interventional study, prospective, mono centric, single-arm~   "
9914|NCT03437044|"~     To date there is very little PD and pharmacokinetic (PK) data on the ticagrelor 60 mg bid~     dosing regimen. In particular, there is no prospective PK/PD study on this dosing regimen in~     patients with DM who are known to have impaired response to clopidogrel therapy. Since DM~     patients frequently require elective PCI due to chronic progression of CAD (and not solely~     because of an acute thrombotic complication), and clopidogrel remains the guideline~     recommended P2Y12 inhibiting therapy for these patients, understanding the PD effects of the~     ticagrelor 60 mg bid regimen in this setting is an unmet clinical need. This is also in light~     of the ongoing THEMIS trial which is specifically evaluating the impact of the ticagrelor 60~     mg bid dosing regimen in type 2 DM patients without a prior major CV event.~   "
9915|NCT03437031|"~     The purpose of this study is to identify whether use of virtual reality devices can improve~     the pain management of women in labor and delivery. The investigators will perform a~     randomized controlled trial of patients in labor at Cedars-Sinai Medical Center.~   "
9916|NCT03437018|"~     The aim of this study is to evaluate the monitoring of moderate diabetic retinopathy by~     tele-expertise~   "
9917|NCT03437005|"~     The global aim of this study is to investigate how the human microbiome changes from baseline~     with commonly used topical medications such as topical antifungals, low to mid potency~     topical steroids and emollients.~      The specific aims are as follows:~        1. Investigate whether ketoconazole cream, a commonly used topical antifungal, causes~          alterations in the human skin microbiome with short-term use.~        2. Investigate whether desonide 0.05 % ointment, a commonly used low potency topical~          steroid, alters the human microbiome with short-term use.~   "
9918|NCT03436992|"~     Diabetes has recently been referred to as the epidemic of the 21st century. The reason why~     women with type 1 diabetes have a 2-3 fold greater risk of cardiovascular disease (CVD)~     compared to men with type 1 diabetes is unknown.The purpose of this study is to investigate~     whether or not estrogen contributes to vascular dysfunction in premenopausal women with~     diabetes.~   "
9919|NCT03436979|"~     The objective of the study is to assess the long term safety, durability of clinical~     effectiveness and cost effectiveness of the NeuGuide™ system when used for vaginal colpopexy~     in the treatment of uterine prolapse.~   "
9920|NCT03436966|"~     Aim of the work: To evaluate the role of CT in diagnosis of IBD~   "
9921|NCT03436953|"~     This is a Phase 2, multicenter, double-blind, placebo-controlled, parallel-group study~     consisting of a screening period of up to 4 weeks, a 4 week randomized double-blind,~     dose-titration treatment period, followed by a 1 week safety follow-up period after the last~     dose of study medication, and a scheduled follow-up safety telephone call one week later.~   "
9922|NCT03436940|"~     The purpose of this study is to improve discharge planning effectiveness by comparing two~     strategies [on-Demand Discharge Planning (DDP) vs. Routine Discharge Planning (RDP)], in~     terms of reduction of hospital readmissions for inpatients classified at intermediate risk of~     complex discharge using the simplified Blaylock Risk Assessment Screening Score (BRASS).~   "
9923|NCT03436927|"~     As a chronic, autoimmune, inflammatory disease of the central nervous system, Multiple~     Sclerosis (MS) is a neurologic problem which the most frequent cause of disability in young~     adults. Fatigue, pain, spasticity, muscle weakness, depression, as well as balance and gait~     disorders are amongst the symptoms of MS. Balance disorders and the falls caused by them are~     the most frequent problems which result in disability of MS patients, with 75% of all~     patients being affected during the course of disease. When considering previous studies~     carried out on physiotherapy and rehabilitation practices in the light of balance disorders~     and other related problems faced by MS patients, it can been that various physiotherapeutic~     approaches are applied with varying follow-up times and in the form of hospital sessions,~     home sessions, or group training. Posture and balance problems in MS patients are tried to be~     solved through long-lasting treatment sessions using traditional methods of physiotherapy,~     where less patient participation is observed. Fatigue, psychological impairment, and~     insufficient motivation are other aspects which influence the success of treatment and which~     need to be addressed in MS patients. In contrast to traditional methods of physiotherapy~     applied in form of long-lasting treatment sessions, technology-supported rehabilitation~     approaches have emerged in recent years. It can be seen that different systems have started~     to be employed in the physiotherapy of many chronic diseases, either alone or in company with~     traditional methods. Even though the clinical use of these systems is becoming widespread,~     there are certain gaps in terms of the systems' impacts, comparative advantages, or cost~     effectiveness. Keeping this in mind, the purpose of this study is to investigate and compare~     the impacts of 'Nintendo Wii Fit' and 'Balance Trainer', as two of the technologic methods~     with therapeutic impact which have started to be used for different diagnosis groups in~     recent years, on the balance and posture parameters of MS patients, with the ultimate aim to~     introduce a whole new point of view to traditional physiotherapy and rehabilitation studies.~   "
9924|NCT03436914|"~     For ERD(erosive reflux disease), which pathogenesis is mainly the acid reflux mechanism,~     primary treatment is therefore PPI. However, NERD(non-erosive reflux disease) is much more~     complex than ERD and there are more factors causing the typical symptoms. As a result, there~     is no consensus for the treatment of NERD besides using PPI similar to GERD(gastroesophageal~     reflux diseas). This study intent to evaluate the effect of PPI(Esomezol) on NERD patients~     and analyze the improvement of symptoms and the factors related to the result.~   "
10542|NCT03428815|"~     This clinical trial will compare how many days per year people with lower limb prosthesis do~     not wear their prosthesis when fitted with a conventional liner and a liner made with phase~     change materials.~   "
9925|NCT03436901|"~     Testicular cancer (TC) affects approx. 1% of Danish men and is the most common cancer in men~     aged 15-35 years. It is the most curable solid cancer type with a 5-year survival rate of~     90-95%. Staging and follow-up of these patients involve 5-10 CT scans of each patient,~     imposing a significant radiation burden: Approx. 3-5 of the 300 Danish patients presenting~     with TC each year are expected to develop a radiation-induced secondary cancer, half of which~     are expected to be fatal.~      MRI is rapidly developing and new WB-MRI can cover large parts of the body in a clinically~     realistic scan time. With this development, it is within reach to nearly eliminate the~     radiation burden by substituting the large amount of CT scans with MRI scans in TC. MRI is~     without any known risk of long-term side effects. Despite this, limited data exist on MRI~     used in follow-up of TC.~      At Aarhus University Hospital, we introduced MRI for the follow-up of TC stage I in 2008. We~     now want to evaluate the results of in this unique cohort of patients and evaluate in a~     prospective trial if the newest WB-MRI techniques can replace CT in patients with TC stage~     II-IV. To the best of our knowledge, no study has investigated how much it is possible to~     reduce the MRI scan time in patients with TC in order to develop a clinically realistic scan~     time while still maintaining an acceptable uncompromised diagnostic accuracy.~      The overall aim of this study is to reduce the risk of radiation-induced secondary cancers in~     patients operated diagnosed with TC by replacing CT as a follow-up imaging method with~     non-ionizing WB-MRI including DWI. We have these specific aims:~        -  To study the ability of WB-MRI with DWI to replace standard CT in TC stage II-III~          patients in a prospective non-inferiority study.~        -  To evaluate if it is possible to reduce scan time in the WB-MRI protocols in the TC~          stage II-III group while maintaining sufficient diagnostic accuracy in order to improve~          clinical application of the techniques.~   "
9926|NCT03436888|"~     The objective of this study is the adaptation of the Pelvic Girdle Questionnaire to the~     French language from France, and the analysis of its psychometric properties. Firstly, a~     translation and adaptation process will be performed according to international guidelines.~     Secondly, the validation process will be performed through a sample of 250 pregnant or~     postpartum women suffering from pelvic girdle pain. They will fill several questionnaires,~     including Pelvic Girdle Questionnaire, that will allow us to analyse psychometric properties~     of the French version.~   "
9927|NCT03436875|"~     Microvascular insulin resistance has been shown to precede myocyte insulin resistance and~     impairments in metabolic function. However, there is no convincing data showing the~     relationship between impaired microvascular flow and impaired metabolic flexibility. Recent~     evidence exists that impaired microvascular blood flow in Caucasians directly contributes to~     impaired metabolic flexibility in Caucasians (under review), however there is no such~     evidence in Hispanics. Since there is a large disparity in cardiometabolic disease in~     Hispanics, this study aims to determine the role of impaired microvascular blood flow on~     impaired substrate oxidation switching (metabolic flexibility) in healthy people at risk for~     developing type 2 diabetes.~   "
9928|NCT03436862|"~     This is a Phase II single-arm open-label study of nivolumab as maintenance therapy after~     autologous stem cell transplantation in patients with Hodgkin lymphoma at risk of relapse or~     progression.~   "
9929|NCT03436849|"~     The purpose of this study is to evaluate the safety and tolerability of single and multiple~     oral doses of ESN364 in healthy Japanese male and pre- and post-menopausal female subjects.~     This study will also evaluate the pharmacokinetics (PK) of ESN364 and its metabolite, and the~     pharmacodynamics (PD) of ESN364 after single and multiple oral doses administration in~     healthy Japanese male and pre- and post-menopausal female subjects.~   "
9930|NCT03436836|"~     Nalbuphine has been used as an adjuvant to bupivacaine in intrathecal, epidural, caudal~     anesthesia and peripheral nerve blocks showing an increase in the efficacy and the duration~     of postoperative analgesia.The aim of this study is evaluation of the effect of nalbuphine~     when used as an adjuvant to a local anesthetic mixture in peribulbar block undergoing~     cataract surgery~   "
9931|NCT03436823|"~     Repeated Transcranial Magnetic Stimulation - R.TMS - is currently part of the treatment for~     depressive illness. This non-invasive technique is designed to stimulate certain areas of the~     cerebral cortex involved in this pathology. FDA approved this treatment in routine for~     depressive illness. R.TMS still remains in assessment. Due to the heterogeneity of methods~     and the weakness of the cohorts therapeutic superiority can not concluded .~      Stimulation parameters remain numerous even if a consensus is beginning to emerge. The~     therapeutic target is the left dorso - lateral prefrontal cortex. The lack of efficacy is~     probably due of the inaccuracy. The empirically location of the target does not take into~     account the inter-individual anatomical differences. The neuronavigation is becoming~     widespread in routine clinical practice.~      The referent nurse stays with the patient all along the rTMS sessions. His role is to set up~     treatment, to ensure the safety and the well-being of the patient. An rTMS session is an~     average of 30 minutes and is a very special moment to create a specific therapeutic~     relationship.~      No study was conducted to evaluate the therapeutic relationship. The assumption is made that~     rTMS with a semi - structured interview provides a qualitative and quantitative clinical~     response greater than a semi - structured rTMS without this nursing care. The investigators~     therefore propose to patients not receiving a semi-structured interview to listen to music~     with eyes closed.~   "
9932|NCT03436810|"~     The objectives of the study will be General Objective is to investigate the effect of TOCCT~     with MI on gait performance in patients with stroke. Speific Objevtives.~      Specific Objectives are to compare the effect of TOCCT with MI and TOCCT with education on~     the spatio-temporal and functional gait variables in patients with stroke, to investigate the~     spatio-temporal and functional gait variables in patients with stroke after receiving TOCCT~     with MI and to investigate the spatio-temporal and functional gait variables in patients with~     stroke after receiving TOCCT with education.~   "
9933|NCT03436797|"~     This is a Phase 2a, open-label, study to assess the effects of AK002, given as monthly~     intravenous infusions at up to 3 mg/kg. A total of 48 patients will be enrolled across 2-4~     sites. All patients enrolled in the study will receive 6 monthly infusions of AK002 and will~     then be followed for another 8 weeks.~   "
9934|NCT03436784|"~     The goal of the study is to determine the immediate and long-term effects of SNAP-Ed on the~     dietary intake of participants.~   "
9935|NCT03436771|"~     This study will provide long-term follow-up for patients who have received treatment with a~     Juno CAR T-cell product in a Juno-sponsored clinical trial. In this study, patients will be~     followed for up to 15 years after their last dose of Juno CAR T cells for evaluation of~     delayed adverse events, presence of persisting CAR T-cell vector sequences, presence of~     replication-competent retrovirus (RCR) or lentivirus (RCL), and survival.~   "
9966|NCT03436368|"~     Renal transplantation is now recognized as a treatment of choice for patients with end-stage~     renal disease. An adequate anesthetic technique should achieve hemodynamic stability and~     enhance perfusion of the transplanted kidney. The aim of this study is to assess the use &~     effects of continuous spinal anesthesia for kidney transplantation recipients, compared with~     balanced general anesthesia.~   "
9936|NCT03436758|"~     Infertility or infertility affects about 15% of couples of reproductive age. It is estimated~     that 80 million people around the world suffer from this problem. Assisted reproduction~     techniques (ART) use culture media (during in vitro fertilization or early embryo~     development) with protein sources that are very different from natural sources. This media~     could produce an added stress to the gametes and embryos that could cause epigenetic~     alterations and health effects during adult life.~      Our working hypothesis is based on studies in animal models (pig and cow), in which it was~     observed that the culture media with reproductive fluids used as additives instead of~     conventional sources of proteins (such as serum albumin) , produce embryos with an epigenetic~     profile closer to that of embryos generated in the maternal oviduct. Moreover, with these~     fluids, blastocysts obtained have a greater number of cells and hatchability than those~     produced with serum albumin alone.~      Therefore, the University of Murcia, with an extensive experience in this area, and the IVI~     Murcia (Valencian Infertility Institute) research team have come together to launch this~     research project in order to determine the advantages of the use of human reproductive fluids~     as additives in embryonic culture media. To do this, 2 specific objectives are proposed,:~        1. Creation of the first collection of human uterine fluid samples for Assisted~          Reproduction use.~        2. To evaluate the use of uterine fluid as a media supplement in the culture media for~          assisted reproduction techniques, by evaluating embryo quality cultured with autologous~          fluid from voluntary patients (autologous culture)~      This achievement would allow us the development of protocols in the nearest ART physiological~     conditions which represent not only a technical challenge but a biomedical responsibility~     that must be addressed to prevent future diseases of the offspring.~   "
9937|NCT03436745|"~     Background:~      Insomnia is associated with difficulty sleeping. The drug zolpidem is widely prescribed for~     insomnia. Women have reported worse effects from the drug than men. Women have higher amounts~     of zolpidem in their body that may persist after waking. Drug exposure may also depend on~     male hormones that change during prostate cancer therapy. Researchers want to see if these~     findings can provide a more-accurate dose to healthy women and men with prostate cancer.~      Objective:~      To study amounts of zolpidem in men who have been diagnosed with prostate cancer before they~     are castrated and after, and to compare these results to healthy women s.~      Eligibility:~      Men ages 18 and older who have been diagnosed with prostate cancer who are planning to~     receive androgen deprivation therapy (ADT)~      Healthy women age 18 and older~      Design:~      Participants will be screened with:~      Blood tests~      Physical exam~      Electrocardiogram (EKG) heart test~      Male participants will confirm their prostate cancer. This can be done with a tumor sample~     tissue from a previous surgery or a report from a doctor.~      Female participants may have a pregnancy test.~      Participants will be admitted to the clinic in the evening and stay overnight. They will:~      Take a 5 mg zolpidem tablet on an empty stomach around 11 p.m.~      Have blood drawn multiple times~      Have physical exams and EKGs~      Answer questions about their symptoms and medicines they are taking~      Male participants will have ADT as part of their standard cancer treatment. After that, the~     testosterone in their blood will be measured. They will repeat the overnight clinic stay.~      Participants will get a follow-up phone call after each stay.~   "
9938|NCT03436732|"~     Background:~      Mesothelioma is cancer of the tissue that lines some organs. A new drug, LMB-100, may bind to~     a protein on mesothelioma tumors and kill cancer cells. But sometimes the body makes~     antibodies that reduce how well LMB-100 works. Researchers want to see if adding the drug~     SEL-110 to LMB-100 will prevent these antibodies from forming.~      Objective:~      To learn how safe and tolerable LMB-100 plus SEL-110 is in people with advanced mesothelioma.~      Eligibility:~      Adults ages 18 and older who have pleural or peritoneal mesothelioma that has not responded~     to prior platinum-based therapy~      Design:~      Participants will be screened with~        -  Medical history~        -  Physical exam~        -  Blood and urine tests~        -  Sample of tumor tissue. This can be from a previous procedure.~        -  Scan of the chest, abdomen, and pelvis. Participants will lie on a table in a scanner~          that takes pictures. A special dye may be injected in a vein.~        -  Positron emission tomography (FDG-PET) scan. A sugar attached to a chemical that gives~          off a signal will be injected before the scan.~        -  Heart function tests~      The study will be done in 21-day cycles. Participants will get the study drugs for up to 4~     cycles. They will get them through an IV catheter (a tube inserted in a vein, usually in the~     arm):~        -  LMB-100 for about 30 minutes on day 1, day 3, and day 5 of each cycle~        -  SEL-110 for about 1 hour on day 1 of each cycle~      Participants will get standard medicines to help prevent side effects.~      Participants will repeat some screening tests during each cycle and about 5 weeks after the~     last dose of study drug.~   "
9939|NCT03436719|"~     This is a randomized, controlled, parallel study to determine the efficiency of oral~     antibiotics in reduction of surgical site infection (SSI) in rectal cancer surgery.~   "
9940|NCT03436706|"~     Aim 1: To characterize allostatic load (AL) biomarkers in a sample of low-income early~     adolescents (N = 225). How many children living in low-income homes have atypical or~     out-of-range biomarker levels, on which biomarkers, and in what combinations (Aim 1a)? Do AL~     biomarker elevations predict physical and mental health problems in early adolescence (Aim~     1b)? How much and what type of change in AL biomarkers occurs between ages 11 and 14 (Aim~     1c)?~      Aim 2: To investigate in the same sample of early adolescents exposed to varying levels of~     early life stress (ELS), the relative contributions made by ELS, recent (past year), and~     cumulative (since age 5) stress exposures to initial AL levels at T1 (Aim 2a), and to changes~     in AL across the two years of the study (Aim 2b).~      Aim 3: To explore the extent to which coping resources, including children's coping skills,~     children's physiologic self-regulation, and parental coping socialization, uniquely and~     synergistically influence AL levels and accumulations in these early adolescents.~   "
9941|NCT03436693|"~     The purpose of this study is to evaluate the efficacy and safety of Canagliflozin (TA-7284)~     in Japanese patients with Diabetic Nephropathy, compared with placebo~   "
9942|NCT03436680|"~     The goal of this clinical research study is to learn if using neurofeedback training can help~     teach patients with peripheral neuropathy (nerve damage that affects motor function) how to~     change their own brain waves to lower their own perception of symptoms and help improve~     overall quality of life.~      Neurofeedback training is a type of therapy that uses an electroencephalograph (EEG) and a~     computer software program to measure brain wave activity.~      This is an investigational study. Neurofeedback training is performed using FDA-approved and~     commercially available methods. Using neurofeedback equipment to teach patients ways to~     change their own brain waves to lower the perception of symptoms and improve quality of life~     is considered investigational.~      Up to 20 participants will be enrolled on this study. All will take part at MD Anderson.~   "
9943|NCT03436667|"~     This prospective study will measure various factors in children coming in for ambulatory~     surgery and attempt to create a scoring system that would be able to predict post-operative~     outcomes.~   "
9944|NCT03436654|"~     The purpose of this study is to test if treatment with medications that reduce the male~     hormone level in the participant's body for a few months before surgery can shrink prostate~     cancer as much as possible, which might reduce the chances of the cancer coming back in the~     future. These treatments include a hormone injection given monthly or every three months and~     the study drugs, which include abiraterone acetate, prednisone, and apalutamide.~      These medications are being used in combination with surgery and maybe radiotherapy because~     studies have shown that any single approach on its own is not sufficient to control or get~     rid of the cancer especially if they have high risk or aggressive features. The researchers~     hope to learn if combining the study drugs with surgery and radiation will get rid of the~     cancer from participants' prostates and reduce their prostate-specific antigen (PSA) to an~     undetectable level.~   "
9945|NCT03436641|"~     Numerous studies dealt with the hospital doctors' work but little is known about the work of~     ICU doctors, especially concerning the medical time spent outside the Intensive Care Unit~     (ICU) which is a significant workload that has never been evaluated to date. The main~     objective of our study was to evaluate the time spent by ICU doctors outside the unit, for~     the management of their patients during the IHT and for the care of patients in other~     departments. Secondary objectives were to describe the organization and distribution of~     medical time outside the intensive care unit.~      In this prospective and observational study, which took place during 5 years, from January~     2012 to December 2016 in the medical ICU of the Nouvel Hôpital Civil at the University~     Hospitals of Strasbourg, every day after the morning medical staff, the anonymized~     information were collected in a register.~   "
9946|NCT03436628|"~     Type 1 diabetes (T1D) afflicts approximately 154,000 people under the age of 20. Most people~     with T1D are diagnosed at a young age; their parents have to manage their child's condition.~     Eventually, the child must begin to take steps to transition to self-management. During the~     transition from parent to adolescent self-management, difficulties arise because adolescents~     may not be fully aware of, or want, to take responsibility for all the necessary tasks to~     successfully manage their T1D. Though there are other apps on the market to help with~     diabetes care, NONE do what the proposed app will do. The proposed self-management mobile app~     allows for monitoring the patients' T1D by linking their self-management information to their~     parents' cell phone, and thus also helps to bridge communication gaps. Prior research~     suggests that these are critical gaps that must be filled in order for successful transition~     in care to occur, the proposed app will help fill some of these gaps.~   "
9947|NCT03436615|"~     This is a phase 2 multi-center, randomized, double-blind, vehicle-controlled ascending dose~     study to be conducted in non-immunocompromised subjects with molluscum contagiosum.~   "
9948|NCT03436602|"~     The study aims at developping and validating an integrated clinico-molecular model for an~     accurate identification of FL patients who are progression free and progressed, respectively,~     at 24 months after treatment.~   "
9949|NCT03436589|"~     The goal of the study is to determine the immediate and long-term effects of SNAP-Ed on the~     food insecurity of the entire household, household adults, and household children. The study~     also aims to determine if there is a dose-response effect on food security after receiving 4~     to 10 FNP lessons and if other characteristics influence the change in food security status.~   "
9950|NCT03436576|"~     The purpose of this study is to compare the effects of autologous serum 20% and autologous~     serum 50% for the treatment of Severe Dry Eye Syndrome~   "
9951|NCT03436563|"~     The goal of this clinical research study is to learn about the safety of giving M7824 to~     patients with colorectal cancer. Researchers also want to learn if the study drug can help to~     control the disease.~      This is an investigational study. M7824 is not FDA approved or commercially available. It is~     currently being used for research purposes only.~      The study doctor can explain how the study drug is designed to work.~      Up to 59 participants will be enrolled in this study. All will take part at MD Anderson.~   "
9952|NCT03436550|"~     The purpose of this study is to determine whether new multiparametric magnetic resonance~     imaging (MRI) methods (including diffusion-weighted MRI, dynamic contrast-enhanced MRI, MR~     elastography and phase-contrast imaging) can be useful in assessing liver damage and degree~     of portal hypertension (a complication of advanced liver fibrosis and cirrhosis) secondary to~     chronic liver disease, compared to ultrasound measurement of liver stiffness [acoustic~     radiation force impulse (ARFI) ultrasound] and routine blood tests. MRI uses magnetic fields~     to look at soft tissues in the body. This study will ultimately help to determine whether~     these methods will be useful in identifying liver disease and their complications that cannot~     be well-understood using current liver MRI techniques.~   "
9953|NCT03436537|"~     Aesthetics for individuals become increasingly important, while the aesthetic effects of~     periodontal disease is an important issue that should be assessed by the patient's~     perception.~      The results demonstrate that the periodontal aesthetic perception scale showed reliable and~     valid scores in healthy controls and periodontal patients.~      The periodontal aesthetic perception scale may be an appropriate tool to assess periodontal~     esthetic in clinical and research settings.~   "
9954|NCT03436524|"~     The study aims at developing a model for the prediction of time to first treatment in chronic~     lymphocytic leukemia patients presenting with asymptomatic early stage disease~   "
9955|NCT03436511|"~     This observational study is designed to more specifically describe the burden of the disease~     and the use of healthcare resources of subjects with eosinophilic COPD that may be eligible~     in the future for a biologic treatment. Subjects who attend a routine follow-up visit and~     fulfill the inclusion/exclusion criteria defined provide a signed informed consent will be~     invited by the investigator to participate in this study. Subjects will be recruited in~     hospital Pulmonology Services across Spain. It is planned to include approximately 20~     centers. To select the final participating centers, a feasibility study has been carried out~     in approximately 50 potential participating centers. It has been estimated that each~     investigator will include 18 subjects during the 4-month inclusion period. Total 354 subjects~     will be required: 250 subjects with an eosinophil level >=150 cells per microliter and 104~     subjects with an eosinophil level <150 cells per microliter. The study inclusion period will~     be 4 months (expected to be from November 2017 to March 2018) and the retrospective data~     collection period will be 12 months prior to the inclusion visit.~   "
9956|NCT03436498|"~     Primary Objective:~      - To assess the safety of SAR341402 and NovoLog® when used in external insulin pumps in terms~     of the number of patients with infusion set occlusions.~      Secondary Objectives:~        -  To assess the safety of SAR341402 and NovoLog® when used in external pumps in terms of~          unexplained hyperglycemia.~        -  To assess the safety of SAR341402 and NovoLog® when used in external pumps in terms of:~             -  Intervals for infusion set changes.~             -  Number of patients with insulin pump for non-delivery alarm.~             -  Patient observation of infusion set occlusion.~             -  Adverse events and serious adverse events.~             -  Number of patients with hypoglycemic events (according to ADA Workgroup on~               hypoglycemia).~   "
9957|NCT03436485|"~     The purpose of this first-in-man study is to evaluate safety and tolerability of ODM-208 in~     patients with metastatic castration-resistant prostate cancer.~   "
9958|NCT03436472|"~     Delirium is a frequent postoperative complication. Its occurrence is associated with worse~     long-term outcomes. In a previous randomized controlled trial, prophylactic low-dose~     dexmedetomidine infusion during the early postoperative period decreased the incidence of~     delirium in elderly patients after surgery. The purpose of this 5-year follow-up study is to~     evaluate whether prophylactic low-dose dexmedetomidine infusion can improve the 5-year~     outcomes in elderly patients recruited in the previous randomized controlled trial.~   "
9959|NCT03436459|"~     This study evaluates the effects of low level laser therapy and extracorporeal shock wave~     therapy in patients with myofascial pain syndrome of the upper trapezius. Half of the~     patients receive laser therapy, half of them receive shock wave therapy for three weeks.~   "
9960|NCT03436446|"~     Value-based healthcare is heavily dependent on the accurate measurement of patient outcomes,~     both immediately after treatment and at long-term intervals. Patient reported outcomes (PROs)~     are often the central component of any quality improvement process as they are patient~     centered, reflect the ultimate objective of the intervention and are endorsed by many~     professional societies as the preferred physician performance metric. Although high response~     rates are critical to producing reliable data to support value-based payment models, quality~     improvement, and stakeholder transparency - especially in arthroscopy in which patients often~     fare well over time and may be less likely to continue with follow-up - response rates to~     outcome surveys after initial recovery from treatment are consistently below 50%. Monetary~     incentives offer only minor improvements in response rates against large increases in already~     rising costs. Individually tailored social incentives - as grounded in current behavioral~     economic practice - offer a potential cost-effective solution to this problem in Sports~     Medicine and arthroscopy.~      The investigators predict that well-constructed, personal social incentives will increase~     response rates for long-term follow-up of episodic care compared to control. The~     investigators predict these rates will vary depending on the patient demographics and other~     characteristics.~   "
9961|NCT03436433|"~     This protocol is designed to assess the need for seizure prophylaxis in the perioperative~     period for patients undergoing craniotomy for suspected diagnosis of new, recurrent or~     transformed glioma (WHO grade I-IV). This will be determined by observing the impact of~     Lacosamide (LCM), Levetiracetam (LEV), or no anti-epileptic drug (AED) on whether visits to~     the emergency department (ED) or hospital re-admissions occur within 30 days after~     craniotomy. A secondary endpoint will evaluate the safety and tolerability of LCM and LEV.~     Exploratory endpoints will evaluate admission duration for the craniotomy, number of~     post-operative provider communications (telephone, email, and additional clinic encounters,~     etc.), and patient risk factors associated with post-operative seizure.~   "
9962|NCT03436420|"~     This is a multicenter, prospective, open-label, Phase 2, proof of concept study to test~     preliminary efficacy and safety of gemcabene in children with established nonalcoholic fatty~     liver disease (NAFLD) incompletely treated by lifestyle changes. The hypothesis of the study~     is that 300 mg of gemcabene once a day for 12 weeks will reduce ALT, hepatic steatosis,~     dyslipidemia and down regulate de novo lipogenesis in children with NAFLD.~   "
9963|NCT03436407|"~     Despite the significant preventive efforts to reduce HIV infections in the past decades, the~     incidence in MSM has plateaued at a higher level after the turn of the millennium. In 2015 a~     reduction in newly diagnosed HIV cases was reported for the first time. Early detection of~     HIV and treatment as prevention may have played a positive role in reducing HIV transmission,~     however, numbers increased again in 2016. Over 90% of HIV positive MSM in Norway are treated~     and virologically suppressed and thereby considered not infectious.~      Since the early days of the HIV epidemic, changes in sexual behaviour and increased use of~     condoms have been advocated and the only tools available to prevent HIV transmission. Later,~     frequent testing and treatment of STIs (including HIV) have been added to the preventive~     measures available. Still, this does not seem to be sufficient for all MSM. The use of PrEP~     is therefore likely an important supplement to prevent HIV infections in MSM at high risk for~     HIV acquisition.~      The main objective of this study is to monitor the impact of PrEP on the subject's~     psychological and sexual health. It is also important to monitor the adherence to PrEP,~     development of drug resistance (in the case of undetected HIV infection at initiation of~     PrEP), frequency of other STIs, changes in sexual behaviour, recreational drug use and~     quality of life. PrEP has proven to be effective in reducing the sexual acquisition of HIV,~     however this requires that the medication is taken as prescribed, whilst the subject is~     exposed to high risk of infection.~   "
9964|NCT03436394|"~     The study will investigate the PK and safety of evobrutinib in subjects with different degree~     of renal impairment as compared to subjects with normal renal function.~   "
9965|NCT03436381|"~     Investigators hypothesize that the obese population (BMI ≥30 kg/m2) who might be at higher~     risk for obstructive sleep apnea (OSA), carries a higher risk of endoscopy associated adverse~     events. The primary aim of our study is to determine predictors of endoscopy associated~     adverse events (airway maneuvers and sedation related complications) in the obese population~     including the use of the STOP-BANG questionnaire (SBQ) and Epworth Sleepiness Scale (ESS). A~     secondary aim is to determine the impact of referral to sleep medicine clinic and home sleep~     test ordered from the gastroenterologist if patient was found to be high risk for OSA by the~     use of validated questionnaires such as SBQ and ESS.~   "
9976|NCT03436238|"~     The purpose of this multicentre, prospective, observational study is to identify robust~     biochemical markers that predict adverse cardiovascular outcomes and mortality in patients~     undergoing major abdominal surgery.~   "
9967|NCT03436355|"~     This study seeks to explore whether increased physical activity in school affects children's~     executive function, aerobic Fitness and childrens self-regulation. The Active school study~     was a 10-month randomized controlled trial. The sample included 449 children (10-11 years~     old) in five intervention and four control schools. The weekly interventions were 2×45~     minutes physically active academic lessons, 5×10 minutes physically active breaks, and 5×10~     minutes physically active homework. Aerobic fitness was measured using a 10-minute interval~     running test. Executive function was tested using four cognitive tests (Stroop, verbal~     fluency, digit span, and Trail Making). A composite score for executive function was computed~     and used in analyses.~      Self-regulation was measured by the Child Behavior Rating Scale.~   "
9968|NCT03436342|"~     Chemokine receptor CXCR4 was expressed in MM and lymphoma cells and CXCR4-targeting molecular~     imaging- 68Ga-Pentixafor PET/CT could be a promising technique to evaluate the extent of MM~     and lymphoma with higher accuracy. This prospective study is going to investigate whether~     metabolic characterization by 68Ga-Pentixafor PET/CT may be superior for diagnosis, risk~     stratification, and prognostic evaluation of MM and lymphoma.~   "
9969|NCT03436329|"~     The purpose of this study is to assess the impact of the sequence of vessel interruption in~     lung cancer patients on tumor cell spread and patient survival by using peripheral blood~     circulating tumor cells.~   "
9970|NCT03436316|"~     This study will be a Phase 1, first in human (FiH) study, consisting of 3 parts (Part 1, Part~     2 and Part 3) in healthy male and female subjects of non-childbearing potential, performed at~     a single study center. Part 1 of this study will be a randomized, single-blind,~     placebo-controlled, single ascending dose (SAD) in healthy non-smoking male and female~     subjects of non-childbearing potential. Six dose levels of AZD8154 are planned to be~     investigated. Depending on emerging data, 1 to 2 additional dose levels may be added at the~     discretion of the Sponsor. Furthermore, one dose level will be repeated using the same~     formulation of AZD8154 but with a larger particle size (Part 1 only). Part 2 of this study~     will be a single cohort, open-label, crossover study in healthy non-smoking male and female~     subjects of non-childbearing potential, to compare a single inhaled dose of AZD8154 with a~     single IV dose of AZD8154. Part 3 of this study will be a single cohort, randomized,~     double-blind, cross-over study in healthy smoking male and female subjects of~     non-childbearing potential, to compare the effect of a single dose of AZD8154 to a single~     dose of placebo in regard to sputum PIP3 fraction.~   "
9971|NCT03436303|"~     A prospective, open‑label, randomized controlled clinical trial to compare the benefits and~     risks of half-dose or standard-dose conjugated equine estrogens(CEE) plus natural~     progesterone or dydrogesterone in menopausal hormone therapy .~   "
9972|NCT03436290|"~     Frequently people diagnosed with cancer experience physical and emotional symptoms during the~     course of their disease. These symptoms can be very distressing to both the patient and the~     family members. The study doctor wants to know if the introduction of a team of clinicians~     that specialize in the lessening of many of these distressing symptoms may improve your~     overall care. This team of clinicians is called the palliative care team and they focus on~     ways to improve your pain and other symptom management (i.e. shortness of breath, fatigue,~     anxiety, etc.) and to assist you and your family in coping with the emotional, social, and~     spiritual issues associated with your diagnosis. The team consists of physicians, advanced~     practice nurses, case managers, and nurses who have been specially trained in the care of~     patients facing serious illness.~      This research study is being done because although many people with cancer receive palliative~     care late in the course of their illness, the study team thinks palliative care may be more~     useful when it is started earlier and in this case before surgery. The main purpose of this~     study is to compare two types of care -usual surgery and cancer care and usual surgery and~     cancer care with comprehensive palliative care services to see which is better for improving~     the experience of patients and families with cancer.~   "
9973|NCT03436277|"~     The L-carnitine has demonstrated effects in the treatment of obesity mainly promoting the fat~     degradation during exercise.~   "
9974|NCT03436264|"~     The proneness to react to noxious stimuli varies widely between individuals and pain ratings~     of seemingly identical noxious stimuli may range from no pain to excruciating pain .~     Imaging studies in healthy subjects have provided useful information on the identification of~     the inter-individual variability in pain perception [2,3,4]. These studies have shown that~     subjective pain reports are closely related to the degree of neuronal activity in several~     brain regions known to be identified in pain processing. Furthermore, there has been a~     growing interest in understanding structural and functional mechanisms of inter-individual~     variability in responses to identical noxious stimuli [5,6,7]. Yet, the relationship between~     pain perception and various anatomical and functional connectivity within resting state brain~     networks is not completely understood. With regard to the anatomical correlate of pain~     sensitivity, differences in grey matter may reflect neural processes contributing to the~     construction and modulation of pain in healthy individuals. As such, studies are inconsistent~     regarding this issue, showing positive [7] or inverse connections [6] between pain~     sensitivity and brain morphology. The inconsistency regarding this issue warrant further~     investigation which may elucidate the relationship between differences in pain sensitivity~     and regional grey matter and may provide novel insights into brain mechanisms contributing to~     that topic. Understanding brain morphology and connectivity within specific regions~     associated with pain processing can provide reliable anchor for the individual differences in~     pain response.~      A widely used approach to examine brain morphology from MRI images is voxel based morphometry~     (VBM). VBM tests for statistically significant differences in regional gray matter (GM)~     density between study groups, and its temporal changes. Diffusion tensor imaging (DTI) is a~     type of diffusion weighted imaging with the advantage of being able to resolve individual~     functional tracts within the white matter (WM) thus, DTI parameters serve as indirect~     measures of structural connectivity via the degree of integrity of WM tracts.~   "
9975|NCT03436251|"~     Human papillomavirus(HPV) infect epithelial cells and have the capacity to stimulate cell~     abnormal hyperplasia, especially by those high-risk HPV types. HPV vaccine primarily~     targeting HPV6/11/16/18 has been available and makes it possible to prevent cervical cancer.~     However, a large population was left unvaccinated, specifically for those aged ones. In~     clinic, patients harboring high-risk HPV is quite prevalent in China or other developing~     nations. Removing the virus and prevention of malignant transformation is required.~      Mild local Hyperthermia with a certain temperature range has been successfully used in the~     treatment of some diseases. It has been utilised in the treatment of some neoplasm, fungal~     and HPV infections. Investigators' study found that local hyperthermia at 44°C could cleared~     HPV in more than half of the patients with plantar warts. Investigators also note the fact~     that in patients with multiple lesions, the clearance of the target lesion is commonly~     followed by clearance of other distant lesions, a phenomenon suggesting that local~     hyperthermia could aid in establishing a specific immune response to eliminate HPV.So the~     purpose of the study is to evaluation local hyperthermia in the treatment of cervical~     intraepithelial neoplasias grade I and II after 3 months, with positive high-risk type HPVs,~     and patients with positive testing for high risk HPVs. Appropriate control arms were designed~     for different conditions.~   "
9980|NCT03436186|"~     Impairment in voice and swallowing functions are common after thyroidectomy. The~     investigators aimed to evaluate the objective functional voice and swallowing outcomes in a~     series of patients undergoing thyroidectomy.~      according to the study, even in the absence of recurrent laryngeal nerve injury, subjective~     and objective swallowing and voice alterations do occur after thyroidectomy.~   "
9981|NCT03436173|"~     Fluoxetine is commonly used to treat adolescent depression, but the neural mechanisms~     underlying antidepressant drugs in the young brain are still poorly understood. This study~     proposes to investigate the effects of a single dose of fluoxetine on emotional neural~     processing in a sample of depressed adolescents, using functional Magnetic Resonance Imaging~     (fMRI).~   "
9982|NCT03436160|"~     Open-label, randomized, microdose study~   "
9983|NCT03436147|"~     Utero-vaginal prolapse is a common, often disabling, condition experienced by women of~     varying ages. The traditional surgical treatment for utero-vaginal prolapse often includes~     vaginal hysterectomy and anterior or posterior colporrhaphy. Growing emphasis on~     patient-centered medicine and patient-generated definitions of surgical success has resulted~     in reassessment of uterine preservation versus hysterectomy at the time of apical POP repair.~     Various techniques have been described for uterine preserving prolapse surgery, which may~     include vaginal sacrospinous hysteropexy, transvaginal mesh kits, abdominal sacrohysteropexy~     using mesh and laparoscopic uterine suspension using sling or mesh. A modified form of~     uterine-preserving prolapse surgery using a combined vaginal and laparoscopic approach was~     introduced and a series of 70 women was reported by Fayyad and Siozos. To date, there have~     been no randomized studies comparing the outcomes of vaginal assisted laparoscopic uterine~     suspension (hysteropexy) with conventional vaginal hysterectomy. Women attending the~     gynecology clinic at a tertiary referral urogynecology unit in tertiary referral training and~     research hospital requesting surgical treatment for STAGE 2-4 symptomatic uterine prolapse~     will be offered participation in a randomized trial, over a 2-year period. Subjects~     participating in the study were randomly assigned to either of two groups: Group A, Vaginally~     Assisted Laparoscopic Hysteropexy (VALH), or Group B, Vaginal Hysterectomy and Mc Call~     Culdoplasty (VH + Mc Call).1 year following surgery, vaginal prolapse will be assessed again~     using the International Consultation on Incontinence Questionnaire for Vaginal Symptoms~     (ICIQ-VS) questionnaire and the Pelvic Organ Prolapse -Quantification (POP-Q) examination by~     another researcher then the operator.~   "
9984|NCT03436134|"~     In France around 90,000 cases of end-stage chronic kidney disease patients treated either by~     dialysis (60%) or renal transplantation (just over 40%).~      In terms of patient survival and quality of life and also economic reasons, the goal in~     France is to increase renal transplantation instead of patients on dialysis.~      After renal transplant, two main causes of the graft loss after the first years are death of~     patient with functioning graft, and chronic AntiBody Mediated Rejection (ABMR).~      Double Filtration PlasmaPheresis (DFPP) has never been evaluated for this indication.~      DFPP makes it possible to treat larger volumes of plasma than plasma exchange, and~     essentially eliminates higher molecular weights molecules including immunoglobulins~     comprising DSA (donor-specific alloantibody) but also the C1q involved in the lesions~     of(ABMR). It is postulated that it will be more effective in treating ABMR than usual plasma~     exchanges.~      A chronic ABMR is the result of the appearance de novo production of anti-Human Leucocyte~     Antigen antibodies (HLA) against one or more graft antigens (DSA: donor-specific~     alloantibody).These DSAs will lead to accelerated arteriosclerosis in the graft vessels,~     which will result in rapidly progressive renal failure, usually associated with a high rate~     of proteinuria.~      Numerous studies have shown that up to 20% of renal transplant patients develop DSA within 5~     years of renal transplantation.~      Today, no treatment has been shown to be effective in the case of chronic ABMR: the basis of~     treatment is the reduction/elimination of DSA ( by apheresis for example) and the prevention~     of its re-synthesis B lymphocytes/plasma cells of the patient (with rituximab for example).~      The investigators of this study propose in the context of the active ABMR demonstrated by~     renal biopsy to evaluate in combination with rituximab, a new apheresis technique double~     Plasma filtration (DFPP) instead of plasma Exchange.~   "
9985|NCT03436121|"~     In this proposal, the investigators will determine if a single dose of intravenous (IV)~     ketamine (in combination with midazolam) reduces pain severity, depressive symptoms and need~     for opiate analgesics both in the ED and in the acute recovery period after ED discharge. The~     investigators will compare the ketamine arm to an active placebo-controlled arm (with~     midazolam).~   "
9986|NCT03436108|"~     Polycystic ovary syndrome (PCOS) is the most common and the most heterogeneous endocrine~     disorder in premenopausal women. Its prevalence is estimated from 5 to 10% depending on the~     diagnosis' criteria .~      Apart from signs of hyperandrogenism such as acne, hirsutism and hair loss; women with PCOS~     usually present with menstrual irregularities and fertility problems ..~   "
9987|NCT03436095|"~     Based on nutritional support, Cardiopulmonary rehabilitation and Levosimendan Bundle~     measures, and making beside checklist of patients with difficult ventilator weaning;~     Implementation of nutritional risk, respiratory function, and cardiac function assessment~     prior to weaning; Regulate the procedure to solve the problem of difficult-weaning patients~     with Non neurogenic disease in ICU. Thereby,improve the success rate of weaning patients, so~     as to shorten the ICU hospitalization time, reduce medical costs, reduce the complications of~     mechanical ventilation, improve the patient's quality of life.~   "
9988|NCT03436082|"~     This is a study to pilot the feasibility of using a novel patient-led, smartphone-based~     mobile health platform (Hugo) for real-world surveillance of outcomes of patients after they~     undergo a bariatric surgical procedure (either sleeve gastrectomy or gastric bypass) and~     catheter-based atrial fibrillation ablation~   "
9989|NCT03436069|"~     Candidate markers have been identified thanks to an original approach developed by our~     research team aiming at detecting ectopic gene expression using public pan-genomic breast~     cancer data. The same approach had already been used and validated in lung tumors, leukemias~     and lymphomas. The main objective of the present research is to use tumor samples from~     patients in a retrospective and prospective cohort to test and validate the relevance of~     these prognostic markers in breast cancer.~   "
9990|NCT03436056|"~     This is a single centre non-randomised open label phase 1 trial of lung SBRT to part of a~     lung lesion in patients with advanced NSCLC in combination with pembrolizumab. This study~     will recruit up to 24 patients whose lung cancer has progressed beyond one line of palliative~     chemotherapy, and an EGFR or ALK inhibitor if an EGFR driver mutation or ALK gene~     rearrangement is present, respectively, and now requires further palliative systemic~     treatment.~   "
10219|NCT03433040|"~     Emergency data suggest 17OHP-C may be less efficacious in obese women. Since obesity is~     associated with lower levels of plasma 17OHP-C, the investigator hypothesize that higher~     doses of 17OHP-C may help to prevent spontaneous PTB among obese women. The study aims to~     compare the pharmacokinetics of 17 OHP-C in obese compared with non-obese women.~   "
9991|NCT03436043|"~     Walled of necrosis (WON) is severe local complication of acute necrotizing pancreatitis.~     Disconnected pancreatic duct syndrome(DPDS) is commonly seen (50-60%) after necrotizing~     pancreatitis and has long term implication like recurrent pancreatic fluid collections (PFC)]~     requiring re-intervention. Incidence of recurrent PFC is more common in patients with DPDS~     (17-50%) compared to others. Studies has shown permanent in-dwelling transmural stent reduces~     recurrence of PFC (1.7% vs 17.4%, p<0.001). Nowadays,WON is effectively managed with~     endoscopic step up approach (96%). Several studies showed dedicated self-expandable metal~     stent (SEMS) are effective compared to the plastic stents in management of WON with decreased~     need of re-intervention. However, SEMS cannot be kept for longer duration because of~     associated adverse events. So, experts recommend to remove SEMS within 4-6 weeks of~     placement. Considering this background, study is planned with aim to see the effect of~     transmural plastic stenting on recurrence of PFC after SEMS removal in walled off necrosis~     with DPDS.~   "
9992|NCT03436030|"~     Healthy reclining adult volunteers, with Valsalva manoeuver, Muller manoeuver, light~     continuous positive airway pressure by mask, passive leg raising, and maximal hand-grip.~     Ultrasound heart images captured before and during.~   "
9993|NCT03436017|"~     Attention-deficit with or without hyperactivity disorder (ADHD) is a real health public~     concern. No easy-use diagnosis tool are available. Metabolomic approaches has brought very~     usefull data in others neurological diseases like amyotrophic lateral sclerosis or autism~     spectrum disorder, as we had shown in previous studies. Targeting on neurotransmitter~     pathways involving in ADHD, metabolomic screening could help to enhance our diagnosis power~     to better help numerus of children. We propose to study the phenylalanine and the tyrosine~     pathways with a multimodal metabolomic approach, in easy-available biological fluid (blood~     and urine), in child or adolescent suspected of ADHD. Our objectives are: 1- to determine a~     specific metabolomic signature of ADHD 2- to compare the diagnostic value of this metabolomic~     signature with the reference methodology for ADHD diagnosis, as now practiced in our~     reference center for learning troubles.~   "
9994|NCT03436004|"~     Evaluation of colonoscopy with a specific device for the detection of adenomas: Multicenter,~     prospective and randomized study~   "
9995|NCT03435991|"~     Rationale: The overactive bladder syndrome is diagnosed clinically by using the ICS criteria~     of ≥8 micturitions and at least 1 urgency episode per 24 hours. To determine whether patients~     fit the criteria, micturition diaries ('sensation-related bladder diaries') and other symptom~     questionnaires with considerable limitations are used. This makes it difficult to get a good~     impression of the fluctuation of complaints during the day / week. These limitations are~     overcome using the Experience Sampling Method (ESM). This is an electronic questioning method~     which is characterized by repeated and random, momentary assessments in the subject's current~     environment and state. This study follows other successful ESM studies done within the~     Gastroenterology and Psychiatry Department. The aim of this study is to evaluate if the ESM~     is more accurate in the assessment of urological complaints in OAB compared to the current~     assessment with the use of the sensations-related bladder diaries (SR-BDs) and retrospective~     questionnaires. Furthermore the aim is to assess the reliability and validity of this~     OAB-specific electronic patient-reported outcome measure (ePRO), based on the Experience~     Sampling Method-principle, for symptom assessment and assessment of triggers for symptoms in~     OAB.~      Objective: To evaluate the accuracy of the ESM to assess urological complaints in OAB~     compared to SR-BDs and retrospective questionnaires. To assess content validity, reliability~     and the accuracy to validate the developed ePRO in OAB patients.~      Study design: The ESM study is a mono-centre, prospective, cross-sectional study.~      Study population: 66 OAB patients will be recruited at the outpatient Pelvic Care Centre in~     Maastricht UMC+, 66 healthy volunteers will be recruited as well.~      Methods: In a period of 7 days, participants will fill out an electronic ESM assessment at 10~     random moments during the day. Moreover, they will fill out a sensation-related bladder diary~     (SR-BD) during the last three consecutive days of filling out the ESM and several symptom~     questionnaires at the end of the study period.~      Main study endpoints: The main study outcome comprehends the psychometric properties of the~     PROM for symptom assessment of OAB symptoms. Secondary outcomes are increase in ESM score for~     OAB symptoms and environmental and psychosocial factors (e.g. as measured by the PROM) from~     one time point (t-1) to the next (t).~   "
9996|NCT03435978|"~     The prevalence of metabolic syndrome (MetS) in young population continues to rise. Obesity is~     a chronic inflammatory disorder in which leptin, adiponectin and C reactive protein (CRP)~     play an important role. This study aimed to determine whether these adipokines are~     significant markers in defining MetS in pediatric population and to assess the effect of~     hypocaloric diet and physical activity on serum concentrations of adiponectine, leptin, and~     high sensitivity CRP (hs-CRP).~   "
9997|NCT03435965|"~     Preterm premature rupture of the membranes (PPROM) is responsible for one-third of all~     preterm births. Optimum treatment relies on accurate diagnosis and gestational age. The~     diagnosis of PPROM is made by a combination of examination, patient history and some simple~     tests.~   "
9998|NCT03435952|"~     Some tumors are difficult to treat with chemotherapy or radiation. One of the reasons is that~     areas of the tumor do not have many blood vessels, which makes it difficult for drugs to~     reach those areas. One way that researchers have recently tried to overcome this problem is~     by injecting special kinds of bacteria into the tumors. These bacteria have been genetically~     changed to remove the chemicals that are poisonous to humans, but are still able to cause~     tumor cells to break down and die. The idea is that these bacteria may be able to assist~     chemotherapy drugs in fighting cancer.~      The goal of this clinical research study is to find the highest tolerable dose of one of~     these bacterial therapies (Clostridium novyi-NT spores) that can be given in combination with~     pembrolizumab to patients with advanced solid tumors. The safety of this drug will also be~     studied, as well as whether it can help to control the disease.~      This is an investigational study. Clostridium novyi-NT is not FDA approved or commercially~     available. It is currently being used for research purposes only. Pembrolizumab is FDA~     approved for the treatment of melanoma and different types of head and neck and non-small~     cell lung cancers. It is investigational to use these drugs in combination with each other in~     various types of advanced cancers.~      The study doctor can describe how the study drugs are designed to work.~      Up to 18 participants will be enrolled in this study. All will take part at MD Anderson.~   "
9999|NCT03435939|"~     The goal of this study is to execute a small clinical proof of concept trial: To examine the~     effects of losartan on mucociliary clearance (MCC) in patients not eligible for CFTR rescue~     therapies~   "
10011|NCT03435783|"~     The overall objective of this research is to use both qualitative and quantitative data to~     inform the development of a technology-based intervention for heavy drinking and sexual risk~     behavior among men who have sex with men (MSM) who are seeking free HIV testing.~     Investigators will be conducting a randomized-controlled pilot test of the intervention among~     MSM seeking HIV testing in community-based settings to explore its potential impact on~     alcohol and HIV-related behavioral outcomes. This research will ultimately produce a~     combined, theory-based, and technology- delivered intervention for heavy drinking and sex~     risk that is fully portable and has been preliminarily tested for efficacy in community~     settings where high-risk MSM engage with prevention services.~   "
10000|NCT03435926|"~     ARMD is the main cause of visual disability after 50 years old in France. Patients with~     active neovascular ARMD are treated with intravitreal injections of antiVEGF. Reinjections~     criteria are decrease of best corrected visual acuity or active neovascularization's signs~     (mostly found on macular OCT but also on angiography when necessary).~      The aim of this study is to evaluate the link between active neovascularization found on OCT~     and eye fixation quality measured with microperimetry in ARMD patients treated with antiVEGF.~      Quality of eye fixation and exudative signs presents or not present on OCT will be gathered~     at each consultation over the two-years follow-up for each patient. The mean central retinal~     sensitivity, the best corrected visual acuity and the bivariate contour ellipse area will~     also be gathered.~      In case no link will be found, for instance bad fixation quality without exudative signs on~     OCT or good fixation stability despite exudative signs on OCT, microperimetry should have an~     interest to improve reinjections criteria with a treatment more suitable to the patient.~   "
10001|NCT03435913|"~     Objective: The aim of this project is to evaluate how intra-abdominal pressure paired coupled~     with different ventilatory positive end-expiratory pressure levels affects the transpulmonary~     driving pressure during pneumoperiteneum insufflation for laparoscopic surgery.~      Methodology: Patients undergoing laparoscopic surgery will be included. The study will~     investigate the relationship between intra-abdominal pressure (IAP) and transpulmonary~     driving pressure (TpDp) and the effect of titration of PEEP on their relationship.~      At four different levels of intra-abdominal pressure, the respiratory driving pressure (RDp)~     and TpDp in each subject will be measured in each subject. The same subject will undergo two~     different ventilation strategies. Demographic data (height, weight, body mass index and sex),~     ASA physical status (surgical risk classification of the American Society of Anesthesiology),~     number of previous abdominal surgeries, number of previous pregnancies, and respiratory~     comorbidities will be collected. Respiratory pressures and mechanics will be recorded at each~     level of intra-abdominal pressure (IAP) during each ventilatory strategy. The variables~     recorded will include: airway pressures (Plateay pressure Pplat, Peak pressure, Ppeak), the~     final esophageal pressure of inspiration and expiration and pulmonary stress index. Mixed~     linear regression will be used to evaluate the relationship between IAP and TpDp by adjusting~     for known confounders and adding individuals as a random factor. The pulmonary distension~     pressure differences will be evaluated with a t test for dependent samples between protective~     and standard strategies. Likewise, an analysis using a mixed linear regression model with the~     pulmonary stress index as a function of the intra-abdominal pressure, the ventilation regime,~     and a specific random intercept term for each subject will be performed.~   "
10002|NCT03435900|"~     The objective of this trial is to evaluate if intraoperative intraperitoneal administration~     of fosfomycin, metronidazole and recombinant human granulocyte-macrophage colony-stimulating~     factor (rhGM-CSF) followed by oral antibiotic for three days is as effective as the current~     intravenous antibiotic treatment given during and three days after appendectomy for~     perforated appendicitis. The primary outcome is the total length of hospital stay, defined as~     the number of hours in hospital after end of operation and until 30-day follow-up.~   "
10003|NCT03435887|"~     Innovative strategies to expedite HIV diagnosis among exposed infants, including at-birth~     testing and two portable point-of-care (POC) diagnostic systems, will be evaluated from an~     implementation framework. The programmatic impact of these tools on early infant diagnosis~     (EID) will be measured in comparison with parallel standard of care (SOC) HIV DNA PCR testing~     initiated at 6 weeks of age.~   "
10004|NCT03435874|"~     This is a dose-escalation, age de-escalation randomised double-blind controlled Phase Ib~     trial to assess the safety, tolerability and immunogenicity of ChAd63-RH5 administered with~     MVA-RH5 in a heterologous prime-boost regimen. Adults (18-35 years), young children (1-6~     years) and infants (6-11 months) will be enrolled in the study. Safety data will be collected~     for each of the vaccination regimens. The humoral and cellular immune responses generated by~     each of these regimens will be assessed.~   "
10005|NCT03435861|"~     For this project, neflamapimod and placebo will be provided free of charge by the EIP company~     (www.eippharma.com). Neflamapimod is currently tested in 2 clinical trials in AD, one in~     Europe (The Netherlands) and one in the USA (clinical trials.gov/VX-745). The company~     commenced in May 2015 dosing in two phase 2a clinical studies in patients with Early AD: one~     in the Netherlands that is focused on PET amyloid imaging as the primary biomarker of drug~     effect, and one in the US (California) that is focused on Cerebrospinal fluid (CSF)~     evaluation to determine CSF drug concentrations and effects on inflammatory markers and~     disease biomarkers. Pharmacokinetic evaluation in these patients has demonstrated blood drug~     concentration levels in the predicted therapeutic range; and importantly, the data from the~     US study demonstrate that the drug achieves target drug concentrations in CSF, thus~     confirming the drug robustly enters the brain in humans.~      The present project offers us a unique chance to test this promising drug in AD patients. The~     aim of the study is to focus on PET neuroinflammation imaging as the primary biomarker of~     this drug effect. The chosen biomarker for imaging neuroinflammation in patients is [1~     8F]-DPA714.~   "
10006|NCT03435848|"~     The purpose of this study is to assesses the benefit, safety, and pharmacokinetics (PK) of~     BST-236 in patients with newly-diagnosed Acute Myeloid Leukemia (AML) who are not eligible~     for standard induction chemotherapy due to advanced age or comorbidities. The Complete~     Remission (CR) rate following treatment with BST-236 will be compared to the CR rate reported~     in historical data in a similar population.~   "
10007|NCT03435835|"~     The purpose of this study is to investigate whether exposure to heat therapy improves calf~     muscle oxygenation and enhances walking tolerance in patients with symptomatic Peripheral~     Arterial Disease (PAD).~   "
10008|NCT03435822|"~     This study is a multi-center randomized controlled trial of children with asthma. The~     objective of the study is to assess the efficacy of China Children Asthma Action Plan~     (CCAAP), which is the first asthma action plan for children with asthma in China, in asthma~     management.~   "
10009|NCT03435809|"~     Many infertility and subfertility issues are treated nowadays with intrauterine~     inseminations. This is a minimally invasive technique that consists in placing sperm into a~     woman's uterus. Inseminations have only a fair success rate despite advances in technology (~     7 % per cycle). The goal of this study is to find an easy intervention that could help with~     success rate. Some studies are showing that the use of Pozzi tenaculum forceps might increase~     rates of pregnancy following intrauterine inseminations. In order to study the impact of this~     intervention, we are conducting a randomized controlled trial comparing the rate of term live~     births after IUI between patients who had their treatment done with a pozzi tenaculum forceps~     and those who had their treatment done without a tenaculum forceps.~   "
10010|NCT03435796|"~     This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all~     pediatric and adult subjects exposed to Gene-modified (GM) T cell therapy participating in a~     previous Celgene sponsored or Celgene alliance partner sponsored study.~      Subjects who received at least one GM T cell infusion, will be asked to roll-over to this~     LTFU protocol upon either premature discontinuation from, or completion of the prior parent~     treatment protocol.~   "
10012|NCT03435770|"~     This study aims to evaluate the safety and efficacy of new ablation catheter developed by~     MEDICAL TAEWOONG for the treatment of pancreatic neoplasm (pancreatic adenocarcinoma or~     neuroendocrine tumour). The ablation is performed using EUSRA needle and radio frequency~     waves under ultrasound imaging. The subject who will be recruited into this study are~     patients who are deemed as non-surgical candidates.~   "
10013|NCT03435757|"~     To overcome the disadvantage of complex morphology and availability of less favorable support~     to retention of graft and clot stabilization in 1-, 1-2-wall periodontal defects, it was~     hypothesized that placement of CPS putty having the property of being easily moldable and~     shaped along with decortication would provide better healing outcome as compared to~     decortication alone in 1-, 1-2-wall periodontal defects.~      Therefore with this rationale, the present study is carried out to evaluate the treatment~     outcomes of decortication with and without use of CPS putty in 1- wall, 1-2-wall periodontal~     defects.~   "
10014|NCT03435744|"~     In this double blind, randomized placebo controlled trial we aim to determine the efficacy of~     simvastatin as an add-on treatment for treatment resistant depression. We will recruit 150~     people with treatment-resistant depression with the aim of determining whether the addition~     of simvastatin (20mg daily) to treatment as usual (TAU) for 12 weeks leads to an improvement~     in depressive symptom compared with placebo added to TAU.~   "
10015|NCT03435731|"~     Continuous positive airway pressure (CPAP) is considered the gold standard therapy for~     obstructive sleep apnea (OSA). However, CPAP users sometimes experience pressure-related~     discomfort. It is thought that lower CPAP pressure may increase comfort and lead to greater~     treatment adherence.~      Mandibular advancement splint (MAS) therapy has been shown to be the preferred OSA treatment~     option among patients. However, MAS therapy is only partially effective in some OSA patients,~     especially in severe cases.~      It is thought that a combination of MAS and PAP therapy may benefit patients in which MAS~     alone is only partially effective. Using MAS and PAP at the same time is called Dual~     Therapy. Dual Therapy may allow a lower CPAP pressure to be applied, which may increase~     patient comfort and therefore increase treatment adherence and overall effectiveness.~      This study will evaluate the effectiveness of 1 month of Dual Therapy in 30 OSA patients.~   "
10016|NCT03435718|"~     The main objective of this study is to provide data on the efficacy profile of different~     doses of oxfendazole when used in Trichuris trichiura infection. The drug will be also be~     examined for efficacy against other common nematodes encountered in man (Ascaris~     lumbricoides, Ancylostoma duodenale, Necator americanus). The study will also provide data on~     the safety and tolerability of the oxfendazole in patients.~   "
10017|NCT03435705|"~     France put a massive effort for improving dementia care through a national Alzheimer plan in~     2008 and this effort was confirmed by the next government (Neurodegenerative Diseases Plan~     2014-2019). Some new care models and interventions have been implemented such as Alzheimer~     specialized teams offering occupational therapy. The teams intervene at home with medical~     prescription. A recent pilot study demonstrated that occupational therapy has the potential~     to bring clinical benefits for both dementia patients and their caregivers. Nevertheless,~     occupational therapy has been designed as a short-term intervention and the end of~     intervention is challenging for therapists and patients. We aim to test the clinical and~     economic efficacy of maintaining occupational therapy over supplementary 4 months in a~     pragmatic randomized controlled trial.~   "
10018|NCT03435692|"~     Hip surgery in children is painful and the optimal modality for managing post-operative pain~     has not been established. This prospective randomized controlled trail compares lumbar plexus~     catheter (LPC), lumbar epidural catheter (LEC) and continuous patient-controlled analgesia~     with intravenous morphine (PCA).~   "
10019|NCT03435679|"~     This study investigates functional outcome and safety after one-stage versus two-stage~     revision of the infected knee arthroplasty.~      Half of participants are treated with a one-stage surgical procedure, while the other half is~     treated with a two-stage procedure.~      The investigators hypothesize that the functional outcome and quality of life of the~     participants is superior after one-stage surgery compared to two-stage surgery.~   "
10020|NCT03435666|"~     Purpose: To demonstrate the bioequivalence between Capecitabine Tablets 500 mg of Qilu~     Pharmaceutical Co., Ltd, China in comparison with XELODA® (Capecitabine) Tablets 500 mg,~     Distributed by Genentech USA, Inc.~      Design: two treatment, three period, three sequence, reference replicate crossover, single~     dose.~      Test Drug: Capecitabine Tablets; Reference drug: XELODA Sample size: Around 45 patients will~     be enrolled to have at least 39 evaluable patients in the study.~   "
10021|NCT03435653|"~     To compare clinically and radiographically the efficacy of demineralized freeze-dried bone~     allograft with and without decortication in the treatment of periodontal intrabony defects~     assessed by gain in clinical attachment, reduction of pocket depth and radiographic bone~     fill.To evaluate clinically and radiographically the regenerative potential of demineralized~     freeze-dried bone graft (DFDBA) material in periodontal intrabony defects.To evaluate~     clinically and radiographically the regenerative potential of demineralized freeze-dried bone~     graft (DFDBA) when used in combination with decortication in periodontal intrabony defects.~   "
10022|NCT03435640|"~     Patients will receive intratumoral (IT) NKTR-262 in 3-week treatment cycles. During the Phase~     1 dose escalation portion of the trial, NKTR-262 will be combined with systemic~     administration of NKTR-214. After determination of the recommended Phase 2 dose (RP2D) of~     NKTR-262, NKTR-262 will be combined with NKTR-214 (Cohort A) and with NKTR-214 plus nivolumab~     (Cohort B). In the Phase 2 dose expansion portion, patients will be treated with NKTR-262 and~     NKTR-214 (doublet) or NKTR-262 and NKTR-214 plus nivolumab (triplet) in the~     relapsed/refractory setting and earlier lines of therapy.~   "
10023|NCT03435627|"~     The purpose of this study is to collect information about safety and effectiveness for long~     term use of Norditropin®. Participants will attend the medical institution according to usual~     practice and receive medical care, as agreed with the study doctor.~   "
10053|NCT03435237|"~     This study will evaluate a new imaging technology, called optical coherence tomography (OCT)~     to examine the asthmatic airways before and after bronchial thermoplasty, which is a new~     treatment option for severe asthmatic patients. The aim of this study is to learn more about~     how airways respond to this new treatment. In the future the investigators hope OCT will aid~     clinicians in the initial assessment, management and long-term follow up of patients~     receiving bronchial thermoplasty.~   "
10024|NCT03435614|"~     Mechanically ventilated critically ill adults may require prolonged administration of opioids~     to facilitate ventilator support and maintain comfort. The prolonged use has been associated~     with withdrawal symptoms upon rapid weaning in critically ill patients, known as the~     opioid-associated withdrawal syndrome (OIWS). Such withdrawal symptoms are well described in~     the paediatric population, however there is a lack of information in the adult population.~     Currently there is no bedside tool to rapidly identify such patients. Recognition of~     withdrawal symptoms is the basis for the development of an assessment tool to identify~     patients with OIWS.~   "
10025|NCT03435601|"~     A multicenter, randomised, double-blind, placebo-controlled Phase 2A/ proof-of-concept study~     to evaluate the efficacy and safety of an intravenous treatment regimen of 300 mg Anifrolumab~     versus placebo in patients with moderately to severely active RA who did not respond to~     biological disease-modifying anti-rheumatic drugs (bDMARDs) and who have a high type I IFN~     gene signature.~   "
10026|NCT03435588|"~     Currently, the best way to evaluate pancreatic masses is through endoscopic-guided needle~     sampling of the mass to determine the diagnosis by looking at the acquired tissue under a~     microscope. This is done by inserting a small camera (endoscope) through the mouth of the~     patient then advanced to the stomach and using ultrasound guidance a sample of the pancreas~     can be acquired through the stomach. The sampling is usually done with a small needle called~     fine needle aspiration needle or FNA. FNA alone is sometimes limited due to inadequate~     acquisition of cells for proper diagnosis under the microscope, which can lead to need for~     repeat endoscopic procedures and delay in diagnosis and possibly treatment. Rapid on-site~     evaluation of cytopathology (ROSE) is where a cytopathologist is next to the physician doing~     the endoscopic procedures and evaluates each sampling performed immediately under the~     microscope and can give feedback to the endoscopist until enough cells has been acquired for~     a diagnosis. This method has been shown to increase the ability to diagnose pancreatic cancer~     but is expensive and requires significant amount of resources. New needles called core~     needles (fine needle biopsy, FNB) have recently been developed which not only acquires cells~     but also the entire tissue structure (histology) and has been shown to be also very accurate~     in the diagnosis of pancreatic cancer.~      The purpose of this study is to compare endoscopy-guided biopsy of pancreatic masses with the~     new core needle (FNB), which can obtain more tissue for diagnosis vs. using a traditional~     needle (FNA) with the help of an immediate assessment of the obtained samples under the~     microscope to determine whether enough tissue has been obtained (ROSE). Both approaches have~     been shown to increase the accuracy of diagnosis in solid pancreatic masses but it is unclear~     which one is superior. This is a randomized trial meaning that the participants would either~     undergo biopsy with the new needle or with the traditional needle plus the addition of~     on-site assessment of the obtained samples. The advantage of the new needle is that it is~     easy to implement and likely much cheaper. If the investigators can show in our study that~     the new needles are as accurate as FNA with ROSE then FNB could be implemented across~     hospitals worldwide in an easier and less expensive fashion.~   "
10027|NCT03435575|"~     Physical inactivity is considered to be one of the ten principal risk factors for death~     worldwide. Children need to perform one hour of daily moderate-to-vigorous intensity physical~     activity whereof at least twice a week these activities are of vigorous intensity. In 2010,~     the percentage of 4-11 year-old normoactive Dutch children was approximately 20%. In~     addition, there is a dose-response relationship between BMI by sex and physical activity~     levels. Previous interventions that aimed to increase childhood physical activity produced~     small to negligible effects. One possible explanation is that individuals were not~     intrinsically motivated towards PA during the intervention period. Children spend a~     substantial amount of their time behind a game consule. There are a number of applications~     that motivate increase in PA in a fun way through engaging individuals in games that mix real~     and computing worlds. These games became known as serious games. In this study we want to~     investigate if the incorporation of a serious game BOOSTH in combination with an activity~     tracker to stimulate physical activity behaviour in overweight/ obese children.~   "
10028|NCT03435562|"~     The purpose of this study is to determine differences in nicotine delivery, user behavior,~     subjective effects, and physiological effects, when cigarette smokers use an two new~     electronic cigarette devices (JUUL and IQOS) relative to their using their own brand of~     cigarettes.~   "
10029|NCT03435549|"~     This will evaluate the effectiveness of automated hovering to encourage patients to be~     discharged to home after hip or knee replacement surgery. Automated hovering includes~     monitoring of physical activity with an activity monitor, tracking of pain scores, daily~     feedback and motivational messages, social influence, and connection to clinicians as needed.~   "
10030|NCT03435536|"~     Pancreatic cancer represents the fourth cause of death by cancer in western countries. The~     only curative treatment is surgery but this one is possible only in 10 to 15 % of cases. To~     date, there are few biomarkers in circulating blood as prognostic or diagnostic markers in~     pancreatic cancer. The purpose of this study is to determine if the pancreatic tumor~     mobilization during its resection impacts the quantity of circulating tumor DNA in peripheral~     and portal blood.~   "
10031|NCT03435523|"~     -  Question: Ventilatory strategy to counterbalance the effect of one lung ventilation~          during thoracic surgery.~        -  Findings: the open lung approach improved oxygenation and lung compliance, reducing~          respiratory system driving pressure and transpulmonary driving pressure.~        -  Meaning: patients undergoing thoracic surgery during one lung ventilation may benefit of~          an open lung approach strategy to avoid ventilator lung injury.~   "
10032|NCT03435510|"~     The Live Donor Champion Program is a clinical education program offered to patients placed on~     the waitlist for kidney transplantation at the Johns Hopkins Comprehensive Transplant Center.~     The goal of the program is to increase patient knowledge regarding end stage renal disease,~     kidney transplantation, and live kidney donation and to help patients identify potential live~     kidney donors. Patients are encouraged to bring family and friends to participate in the~     program and act as advocates on their behalf. These friends and family members are labeled~     live donor champions and work to assist the patient in spreading awareness about end stage~     renal disease, kidney transplantation, and live kidney donation.~      The objectives of this project are to pilot-test and optimize strategies for the~     dissemination of the Live Donor Champion program in the clinical transplant center setting.~     The goals of the study are to develop an implementation protocol for centers who want to~     establish a live donor champion program at their institution.~   "
10054|NCT03435198|"~     The investigators are investigating the biochemical fingerprint of hypoglycemia (low blood~     sugar) in the breath of people with type 1 diabetes.~   "
10055|NCT03435185|"~     The investigators aimed to evaluate the efficacy of greater occipital nerve and supraorbital~     nerve blockade with local anesthetics for the preventive treatment of migraine without aura.~   "
10056|NCT03435172|"~     The primary objective of the protocol is to evaluate preliminary safety and feasibility of~     ADRCs via intravenous delivery in the treatment of deep partial and full thickness thermal~     wounds.~   "
10220|NCT03433027|"~     The purpose of this study is to evaluate the safety, tolerability and efficacy of~     intratumoral injections with an Epidermal Growth Factor Receptor (EGFR) AntiSense DNA~     (BB-401) in patients with metastatic/recurrent HNSCC.~   "
10033|NCT03435497|"~     This randomized controlled pilot study of the Game Changers program will:~        1. Assess the feasibility and acceptability of implementing an HIV prevention advocacy~          intervention with people living with HIV who are in HIV care, and who will be trained to~          be advocates of HIV protective behaviors within their social networks.~        2. Assess preliminary intervention effects on a) protective behavior of the HIV-positive~          clients (condom use, partner concurrency/number of partners, engagement in HIV care, ART~          adherence); and b) diffusion of prevention messages across the network, as assessed by~          the content and extent of communication with network members about protective behaviors~          (condom use, partner concurrency/number of partners, HIV testing, engagement in HIV~          care, circumcision), HIV disclosure, and HIV stigma.~        3. Explore characteristics of HIV-positive clients who more effectively engage in~          prevention advocacy (in terms of socio-demographics, network characteristics, and~          network position and type of alters receiving advocacy).~   "
10034|NCT03435484|"~     The proposed study aims to examine several iterations of instructions/reminders that patients~     receive for completing the Health Assessment Questionnaire (self-reported health outcomes)~     for their outpatient visit at NYU Langone Orthopedic Center. The goal is to increase the~     completion rates of patient-reported health outcomes.~   "
10035|NCT03435471|"~     Clinician directed prophylactic swallowing therapy will improve immediate (four weeks +/- two~     weeks) and short-term (26 weeks +/- four weeks) post-treatment swallowing function and~     quality of life versus patient directed home exercises.~      The purpose of this prospective, interventional, pilot investigation is to determine whether~     clinician directed swallowing therapy will improve patient swallowing function outcomes and~     quality of life in the immediate and short-term basis compared to patients receiving standard~     of care patient directed independent home swallowing therapy. Patient compliance with home~     exercises programs is reportedly inconsistent. Patients may experience changes in their~     physical functioning and overall well-being that may impact their ability to follow-through~     with independent home therapy. Clinician directed swallowing therapy allows for ongoing~     assessment of changes that may warrant modifying the therapy program in terms of intensity of~     exercises and/or expectations. This facilitates individualizing the patient's therapy plan to~     maximize their function and ability to achieve goals. It is anticipated that individualizing~     swallowing therapy through weekly session will result in improved swallowing function.~   "
10036|NCT03435458|"~     The rate of obesity increases continuously in France as in many developing countries.The risk~     of cesarean delivery is increased in obese compared to normal-weight women and postpartum~     complications as infections, thromboembolic events and related maternal death, are more~     common among obese women who deliver by cesarean than both normal-weight women with caesarean~     deliveries and obese women with vaginal deliveries. Unfortunately, obesity is associated with~     a higher rate of failed induction requiring a cesarean delivery and especially in~     nulliparous.~      Methods of induction for obese women have to be improved to decrease the c-section rate but~     we should also be cautious on the type and dose of PG not to affect the neonatal wellbeing~     associated with uterine hyperstimulation.~      The aim of this study is to demonstrate the efficacy of the association of mechanical and~     pharmacological cervical ripening (balloon catheter plus 50 µg oral prostaglandin E1) versus~     pharmacological cervical ripening alone (50 µg oral prostaglandin E1) to reduce the rate of~     caesarean sections in nulliparous obese women.~   "
10037|NCT03435445|"~     Clinical trial to test the efficacy of an online platform based on behavior change principles~     in promoting weight loss among overweight and obese students and employees of the Federal~     University of Minas Gerais. The hypothesis is that participants of the group which use the~     platform with or without a dietitian coaching will lose more weight than those allocated to~     the group who receives dietary and physical activity orientations by educational videos only.~   "
10038|NCT03435432|"~     During dietary fat absorption, the gut packages the majority of the fats into lipid particles~     that are secreted into blood circulation. The gut is also capable of storing a considerable~     amount of fats that can be released at a later time upon receiving certain stimulus signals.~     One of the signals is glucose ingestion. This protocol examines blood lipid responses to a~     glucose drink. Participants drink a fatty formula and 5 hours later drink either a glucose~     solution or water (as control), in one of two randomized study visits. Blood lipid levels are~     monitored throughout the study period.~   "
10039|NCT03435419|"~     New point-of-care (POC) tests are needed and assessing the performance of these tests for~     cutaneous leishmaniasis (CL) in Afghanistan may help increasing the number of CL patients~     with access to accurate diagnosis, and enable prompt treatment. Simpler tests could improve~     treatment access and benefit patients and communities, by reducing the risk of sequelae and~     the risk of disease transmission. CLeishPOCAFG aims to advance the diagnosis of CL by using~     more accurate and field-amenable methods.~   "
10040|NCT03435406|"~     to investigate the prevalence of hepatopulmonary syndrome in cirrhosis patients caused by~     Hepatitis B in western China~   "
10041|NCT03435393|"~     Whether a mapping algorithm Ripple-mapping is able to rapidly identify the areas of~     long-duration multicomponent electrograms which constitute the targets for ablation for an~     automated strategy remains to be assessed.~   "
10057|NCT03435159|"~     After lumbar pain, neck pain is the most common cause of patients needing chiropractic care;~     the second most common cause of spinal manipulation use (1). Manipulation and mobilization~     are commonly used by chiropractors, osteopaths and manipulative physiotherapists in the~     treatment of neck pain. Many studies show that the Activator instrument is also used for this~     purpose in the chiropractic profession (2) There are several published case reports that~     relate to neck manipulation to vertebral artery dissection and stroke. The prevailing theory~     is that the neck extension and / or rotation may damage the vertebral artery in the foramen~     transversarium, especially at the C1-C2 level (2). However, most cases of extracranial~     vertebral artery dissection are thought to be spontaneous (3).~      In the literature, there have been no studies investigating the effects of~     instrument-assisted spinal manipulation on vertebrobasilar and internal carotis arteries. the~     aim of this study to compare the effect of manual and instrumental spinal manipulation on~     blood flow parameters of vertebrobasilar and internal carotis arteries on healthy persons~     which have mechanical neck pain and asymptomatic in vertebrobasilar insufficiency test.~   "
10042|NCT03435380|"~     The primary purpose of this study is to determine the impact of maximizing patient and~     primary care provider (PCP) activation on breast cancer surveillance rates among women~     previously treated with chest radiotherapy (RT) for a childhood cancer. This is a 12-month,~     3-arm randomized controlled trial using a smartphone intervention with data being collected~     at baseline and 12-months through patient and provider surveys and medical record review.~     Eligible women treated for a childhood cancer with chest RT will be randomly sampled from the~     Childhood Cancer Survivor Study (CCSS) and randomly selected to one of three groups: control,~     patient activation (PA) using a smartphone-based intervention, or patient activation +~     primary care provider activation (PA+PCP) which will include physician materials about breast~     cancer risk in this population along with guidelines for breast cancer surveillance.~     Participants in all groups will receive mailed targeted print materials as an educational~     resource about their previous chest radiation and breast cancer screening recommendations.~     The primary outcome is a medical record confirmed breast MRI and mammogram with the goal of~     increasing the rate of women completing the national guideline-based recommended combination~     of breast MRI and mammogram. This study will test the hypothesis that women in the PA and~     PA+PCP groups will have significantly higher rates of breast cancer surveillance (breast MRI~     and mammogram) than women in the control group. In addition, the hypothesis that women in the~     PA+PCP group will have significantly higher rates of breast cancer surveillance than women in~     the PA group will also be tested.~   "
10043|NCT03435367|"~     Venipuncture and intravenous (IV) access continue to be the most common causes of pain and~     distress among children in the pediatric emergency department. Virtual reality has been~     successful for reducing pain and fear in many clinical scenarios, including port access in~     oncology patients, anxiety disorders, phobias, burn and wound care and others. There is only~     one previous study examining virtual reality distraction to reduce procedural pain during IV~     insertion in pediatric patients and no previous studies examining this in the emergency~     department setting. In this study, the investigators will compare immersive virtual reality~     (an interactive underwater environment) to the current standard (tablet device/iPad playing a~     movie) for distraction to reduce procedural pain during IV insertion. The investigators~     hypothesize that the immersive quality of the virtual reality will reduce patient's pain~     scores, fear scores and tachycardia during and after the procedure, and have minimal effect~     on departmental flow and nursing satisfaction. If this feasibility pilot study yields~     positive results, the investigators plan to expand to a larger randomized control trial.~   "
10044|NCT03435354|"~     Our cluster randomized controlled trial of a novel clinical practice change will IMPACT the~     physical activity (PA) of children living with congenital heart defects (CHD) through our~      Innovative and pragmatic approach to systematically incorporate PA counselling within each~     clinic visit. Long-term, the focus is to prevent or treat the most common secondary~     morbidities of these patients (atherosclerosis, anxiety, depression) through enhanced PA. We~     have previously shown that home-based, PA interventions can increase daily PA and enhance PA~     motivation, motor skill and fitness when delivered via an intensive research intervention.~     Our objectives for this study are to~      Measure the feasibility and efficacy of PA counselling using clinical resources among~     paediatric CHD patients (daily PA, PA motivation, competence, quality of life) and on clinic~     systems (% patients counselled, clinic/kinesiology personnel support required, clinic visit~     time, # of PA questions). Our~      Patient-empowering, ready-to-use, self-explanatory tool kit of clinician PA resources and~     patient/family/clinician friendly searchable electronic PA database will be used to promote~     the~      Active lifestyles that are critically important to physical/mental health, peer socialization~     & childhood growth/development. 90% of children are not active enough for optimal health.~      We initially target children with CHD because they are less active than peers, and their most~     important secondary morbidities can be prevented or treated through PA. Our~      Collaborative approach with patients, their families and leaders in paediatric cardiac~     healthcare will optimize our PA tool kit and novel practice change for~      Translation to all paediatric CHD healthcare systems (primary, secondary, tertiary) through~     our pan-Canadian Cardiac Kids Quality of LIFFE Research and Knowledge Exchange Network, a~     collaborative of 10 patient/family support networks and 10 paediatric cardiac clinics in 6~     provinces focused on Learning, Independence, Friends, Fitness & Emotional health (LIFFE).~   "
10045|NCT03435341|"~     Prospective, multicenter, observational, national study (EPA-SP) that aims to describe the~     survival and the quality of life, the clinical management strategies and the prognostic~     factors for survival related to the patient, in a prospective cohort of patients over 60 with~     AML diagnosis in Spain and treated outside of clinical trials; that is, under conditions of~     standard clinical practice.~      The study will last 24 months in total from the inclusion of the first patient until the end~     of the last patient's follow-up~   "
10046|NCT03435328|"~     This study evaluates response of abnormal low salivary flow rate to transcutaneous electrical~     nerve stimulation (TENS) in diabetic type 2 patients. Response of saliva monitored for all~     participants receiving only one session of 5-minute extraoral TENS on bilateral parotid~     glands.~   "
10047|NCT03435315|"~     The main purpose of this study is to better understand the effects of two types of treadmill~     exercise programs that include education and/or techniques that may be helpful for exercise~     among individuals with, or at risk for, metabolic syndrome.~   "
10048|NCT03435302|"~     This is a a multicenter, randomized, controlled, phase III trial comparing High-Dose IFN-a2b~     with Temozolomide Plus Cisplatin as Systemic Adjuvant Therapy for Resected Mucosal~     Melanoma.The study objective is to compare efficacy and safety of High-dose IFN-a2b and~     temozolomide-based chemotherapy as adjuvant therapy.~   "
10049|NCT03435289|"~     This is a single arm, open-label study of CPI-613 in combination with gemcitabine and~     nab-paclitaxel for patients with locally advanced or metastatic pancreatic cancer never~     treated with systemic chemotherapy.~   "
10050|NCT03435276|"~     This is a randomized, single-blind, placebo-controlled study conducted on healthy male~     subjects at a single study center to assess the safety, tolerability and the pharmacokinetics~     of AZD9977 following multiple-ascending oral doses at steady state~   "
10051|NCT03435263|"~     According to high tendency for admission of cases of premature rupture of membranes (PROM)~     for fear of maternal & fetal complications, we compare here between cases managed at hospital~     with other managed at home for if there any difference between in maternal and neonatal~     outcome.~   "
10052|NCT03435250|"~     This study will evaluate the safety, pharmacokinetics, pharmacodynamics, and clinical~     activity of AG-270 in subjects with advanced solid tumors or lymphoma with homozygous MTAP~     deletion.~   "
10289|NCT03432130|"~     The study will investigate the effect of structural training program and body composition on~     injury occurrence in hip-hop dance. Assuming that training program can significantly lower~     the number of injuries (experimental group will have less injuries during and at the end of~     the trial) and that body fat percentage negatively effects injury occurrence (dancers with~     higher body fat percentage will be more often injured).~   "
10058|NCT03435146|"~     Single-arm, two-center, Phase I/II clinical trial assessing the pharmacokinetics (PK),~     safety, and tolerability of once-weekly rifapentine and isoniazid (3HP) for the treatment of~     latent tuberculosis infection among individuals with HIV infection taking dolutegravir-based~     (DTG) antiretroviral treatment. The study population will be individuals with HIV taking DTG~     and 2 nucleoside reverse transcriptase inhibitors for ≥ 4 weeks, who have a suppressed HIV-1~     viral load (VL), and are candidates to receive TB preventive therapy. Sample size is 60~     participants divided into two main groups Group 1 (1A (n=12) and B (n=18)) and Group 2(n=30).~     The first 12 participants (Group 1A) will undergo semi-intensive PK sampling and will be key~     to determining whether an increased dosing of DTG is required in groups 1B and Group 2 due to~     accelerated DTG clearance due to 3HP induced drug-drug-interactions. Group 1B will receive~     dolutegravir at the new dose (if applicable) and will also undergo semi-intensive PK~     sampling. The subsequent 30 (Group 2) will receive DTG at the new dose and will only have~     sparse PK sampling.~   "
10059|NCT03435133|"~     The investigators propose to perform a randomized clinical trial comparing prasugrel vs.~     ticagrelor in 60 patients with ST elevation acute myocardial infarction (STEMI) undergoing~     primary percutaneous coronary intervention. The principal objective of the study would be~     analyzing the difference in myocardial infarction size measured by cardiac magnetic resonance~     at 6 months~   "
10060|NCT03435120|"~     In cancer patients, pain is one of the most common symptoms. The range of reported prevalence~     of pain varies from 33% to 64% including different stages of cancer, during or after~     anticancer treatment. Moreover, despite the optimal management of basal chronic pain, 66% of~     these patients have reported breakthrough pain which has a severe impact on quality of life.~     There is insufficient clinical information on the quality of life of cancer patients with~     breakthrough pain treated in medical oncology services according to routine clinical~     practice. For this reason we consider it is appropriate to prospectively evaluate the quality~     of life of cancer patients with cancer breakthrough pain in medical oncology services as well~     as other factors that can affect quality of life. This post-authorization observational study~     will assess the quality of life of cancer patients with breakthrough cancer pain treated in~     medical oncology services in Spanish hospitals.~   "
10061|NCT03435107|"~     The POLE mutations represent high somatic mutation loads in patients with colorectal cancer,~     especially in those with MMR proficient or MSS, therefore, tumors harbouring POLE mutations~     might be susceptible to immune checkpoint blockade.~      Based on these reasons, the investigators planned a phase II study of durvalumab monotherapy~     in patients with previously treated, metastatic, MMR deficient (MSI-H) or POLE mutated~     colorectal cancer.~   "
10062|NCT03435094|"~     Compare the data obtained with two formulations of alendronate 70 mg (tablets vs effervescent~     tablet for buffered solution) on the change in bone turnover markers, on gastric tolerance~     and on treatment adherence (including compliance and persistence).~   "
10063|NCT03435081|"~     The purpose of this study is to evaluate the efficacy and safety of baricitinib in adult~     participants with moderate to severe atopic dermatitis.~   "
10064|NCT03435068|"~     The aim of this study was to evaluate the degree of clinical discomfort and the issues~     experienced by patients and to use a software image program to compare wound healing during~     the 2-week period following gingivectomy performed with different techniques.~   "
10065|NCT03435055|"~     The purpose of this study is to understand how a commonly used drug, nitrous oxide, acts on~     the brain to reduce pain. Nitrous oxide is commonly used in anesthesiology but there is~     limited knowledge on how this drug affects functional networks in the brain.~   "
10066|NCT03435042|"~     Background: A lot of children with cancer suffer from emotional distress, fatigue and~     relational difficulties. Their parents are also impacted by the disease: their~     responsibilities increase and they can feel more distressed and tired. Different~     psychological interventions designed for ill children and their parents seem to be efficient~     to improve their social functioning, coping strategies and well-being. However, more research~     is needed in this field. Hypnosis is often used in paediatric oncology, mostly to decrease~     procedure-related pain and distress. It has been used efficiently to improve the well-being~     of adults with cancer. This paper describes a pilot study designed to assess the feasibility~     and interest of a group intervention combining self-care and hypnosis for children with~     cancer and their parents, and a quasi-experimental protocol aimed at assessing the efficacy~     of this group intervention to improve the quality of life of children and their parents.~      Methods: Our pilot study showed that our intervention was feasible and positive for the~     participants. To test the efficacy of the intervention, two groups will be set up: one with~     children with cancer and their interested siblings, and one with their parents. Data will be~     collected for each group before and after the intervention by questionnaires and a~     semi-structured interview.~      Discussion: There is a growing interest in hypnosis in oncology settings. The results of this~     study should improve knowledge about the efficacy of a group intervention combining self-care~     and hypnosis to improve quality of life of children with cancer and their family.~   "
10067|NCT03435029|"~     The aim of the study was to analyze the effectiveness of a comprehensive cognitive~     remediation program (REHACOP) in the non demented elderly, obtaining improvements in~     cognition and functional skills. It was a longitudinal randomized controlled trial with three~     assessments: basal, post-treatment, and 12-month follow-up.~      Recruitment and enrollment were conducted between September 2012 and November 2016. All~     participants underwent a clinical interview and an extensive neuropsychological battery.~     Patients were randomized in an experimental and a control group. The groups were formed by a~     maximum of eight participants run by an experienced therapist. The experimental group~     received cognitive remediation for 3 months, 3 times per week 60 minutes per session. The~     control group consisted of occupational group activities (reading the newspaper, drawing,~     singing or doing crafts) with the same frequency as the experimental group. Post-treatment~     assessment was carried out within the first week after completing the intervention. Finally,~     longitudinal follow-up at 12 months with neuropsychological assessments will be performed.~      Objective: To examine the efficacy of a comprehensive cognitive training program (REHACOP) to~     improve cognition, clinical symptoms and functional disability for the elderly.~   "
10290|NCT03432117|"~     This trial is multicenter prospective study to evaluate clinical efficacy of respiratory~     rehabilitation personalized mobile services for respiratory disease.~   "
10068|NCT03435016|"~     The aim of this study is to evaluate non-invasive imaging techniques for assessing treatment~     response in known Crohn's disease.~        1. Comparing imaging modalities:~           The applicability of small bowel colon capsule endoscopy (SBCCE), magnetic resonance~          enterocolonography (MREC) and ultrasound (US) for diagnosing ulcer healing after medical~          treatment in patients with symptomatic Crohn's disease compared to ileocolonoscopy.~             1. Sensitivity and specificity for ulcer healing~             2. Changes in activity parameters for SBCCE, MREC and US before and after medical~               treatment.~             3. Feasibility of SBCCE, MREC and US for assessing treatment response in known Crohn's~               disease.~        2. Treatment induced bowel wall alterations visualized with ultrasound:~             1. A non-blinded study of bowel wall changes detected with repeated US examination~               during medical treatment of known Crohn's disease.~             2. Changes in bowel wall thickness, vascularity and elastography parameters, and time~               to normalization of the bowel wall.~   "
10069|NCT03435003|"~     Bariatric surgery remains the most effective therapy for obesity. Postoperative nausea and~     vomiting (PONV) are commonly reported following bariatric surgery. The proposed study focuses~     on the most common bariatric procedure performed, laparoscopic sleeve gastrectomy (LSG), and~     aims to assess the effect of a post-operative nausea and vomiting-specific intervention. The~     investigators hypothesize that the intervention group will experience a reduction of~     nausea-related prolonged hospital stay and significantly improve patient-reported quality of~     recovery from surgery and quality of life.~   "
10070|NCT03434990|"~     The aim will be to compare a experimental group submitted to a protocol of spinal~     manipulation and myofascial release; and a control group composed by spinal manipulation~     only, in individuals with chronic non-specific low back pain. This is a randomized controlled~     trial, characterized by the application of manual therapy, in two modalities: spinal~     manipulation plus myofascial release and spinal manipulation alone. Participants will be~     enrolled and randomly allocated into two groups: 1) spinal manipulation plus myofascial~     release, totaling 6 sessions, 2x/week, for 3 weeks; 2) spinal manipulation: 6 sessions,~     2x/week, for 3 weeks. Participants will be evaluated in two different moments: 1) Baseline~     (pre-intervention); 2) at the end of intervention period (3 weeks). The primary outcomes will~     be pain intensity (measured in centimeters with the visual analogue scale - VAS) and~     functionality (measured by the Quebec questionnaire - QDS). The secondary outcomes will be~     muscle function (measured by isokinetic dynamometer and Biering-Sorensen test), postural~     balance (measured by the Y Balance test), pain threshold (algometry, in kgf) and perception~     of recovery (Likert scale of 6-points). Data analysis will be performed with the SPSS~     (Statistical Package for the Social Sciences) software version 24.0. Data normality~     assumptions will be confirmed by the Shapiro Wilk test. If the assumptions were met, a mixed~     ANOVA with repeated measures will be adopted, based on the outcomes (pain, functionality,~     muscle strength and postural balance) and the independent variables (groups), for the~     comparison between pre-intervention and post-intervention. Spinal manipulation plus~     myofascial release is expected to have better effects than spinal manipulation alone,~     associated with the outcomes of interest.~   "
10071|NCT03434977|"~     The purpose of this study is to assess the pharmacokinetics of TAK-536 and effect of food on~     the pharmacokinetics following single oral administration of TAK-536 pediatric formulation in~     Japanese healthy adult male participants.~   "
10072|NCT03434964|"~     To evaluate the intraoperative effectiveness of the AIFIB software in real time in the~     detection of atrial fibrillation drivers during an ablation procedure.~   "
10073|NCT03434951|"~     Double-blinded randomized control study investigating intrathecal morphine as an additive to~     spinal anesthesia in patients undergoing elective total knee arthroplasty. The investigators~     aim to include a total of 120 patients, randomized to two equal groups. Participants in the~     intervention group are administered intrathecal 0,2mg morphine and 12,5mg bupivacaine for~     spinal anaesthesia. Participants in the placebo group are administered 12.5mg bupivacaine and~     saline to match the volume of intervention goup. Primary end points are opioid consumption~     and possible adverse effects.~   "
10074|NCT03434938|"~     Background: Rehabilitation pathways are crucial to reduce stroke-related disability.~     Motivational Interviewing (MI), a centred-person intervention aimed to empower and motivate~     the patient, could be a resource to improve rehabilitation and its outcomes for older stroke~     survivors.~      Objective: The IMAGINE project aims to assess the impact of MI associated to standard~     geriatric rehabilitation, on 30 days functional improvement measured by the Functional~     Independence Measure (FIM), compared to standard geriatric rehabilitation alone, in patients~     admitted to geriatric rehabilitation after a stroke. Secondary objectives will be to assess~     the impact on physical activity and performance, self-efficacy, sense of coherence, safety,~     cost-utility and participants' experience, plus functional status at 3 months.~      Methods: Multicenter randomized clinical trial in three geriatric rehabilitation departments.~     Older adults after mild-moderate stroke without previous dementia, post-stroke severe~     cognitive impairment or delirium at admission, severe previous disability, aphasia or~     terminal conditions will be randomized into the control or the intervention group (136 per~     group, total N = 272). The control group will receive written information about the benefits~     of exercising, besides standard rehabilitation. The intervention group, in addition, will~     receive 4 sessions of MI by trained nurses. A shared tailored plan based on patients' goals,~     needs, preferences and capabilities will be agreed. Besides the FIM, in-hospital physical~     activity will be measured through accelerometers (activPAL) and secondary outcomes using~     internationally validated scales. As a complex intervention, a process evaluation and~     cost-utility assessments will be performed too.~      Results: Final results are expected by end of 2020. Implications: This project aims to~     achieve impacts on functional status, disability and physical performance and behavioral~     (increasing physical activity) and psychological implications (on general self-efficacy and~     sense of coherence) through a non-pharmacological and likely accessible, acceptable and~     scalable intervention. Efficiency and value, based on costs/quality adjusted life years, will~     be assessed. Moreover, a reduction in post-stroke disability would have social benefits also~     for families and would reduce health and social care costs. In brief, advances will be in~     terms of a better rehabilitation process.~   "
10075|NCT03434925|"~     This project is dedicated to identify the patients with possible higher risk of adenoma~     recurrence who should have follow-up colonoscopy in yearly interval. As a result, it can lead~     to optimizing the of follow-up colonoscopies intervals in real-world practice.~   "
10076|NCT03434912|"~     The primary objective of this study is designed to evaluate the enumeration of circulating~     tumor cells and identify the potential biomarkers associated with clinical outcome. The~     secondary objective is to explore whether the changes of tumor related rare cells associates~     clinical outcome.~   "
10077|NCT03434899|"~     The aim is to evaluate a novel treatment routine where contact through a smart phone/computer~     is used for online support for patients suffering from chronic widespread pain (CWP). The~     outline is that patients are encouraged to perform physical activity during a period of 12~     months with online support from a physical therapist.~   "
10078|NCT03434886|"~     A multifactorial, parallel group, randomised control study in cystic fibrosis (CF) patients~     aged 13-30 years over an 18 month period. Patients will be offered read-only access to their~     CF registry electronic health record (CF View), or educational videos on CF (videos), or~     videos and CF View, or usual standard of care. The study aims are to examine the effect of~     patient access to C View on a range of clinical outcomes, health service usage, health~     literacy and patient reported outcomes.~   "
10079|NCT03434873|"~     This work is intended to assess the effect of repetitive magnetic stimulation on the sacral~     roots versus repetitive magnetic stimulation on motor cortex in multiple sclerosis patients~     with the lower urinary tract dysfunction.~   "
10080|NCT03434860|"~     Probiotics have beneficial effect on obesity related disorders in animal models. Despite a~     large number of animal data, randomized placebo-controlled trials (RCT) concluded that~     probiotics have a moderate effect on glycemic control-related parameters. However, effect of~     probiotics on insulin resistance are inconsistent. In this double-blind single center RCT,~     effect of alive multistrain probiotic vs. placebo on insulin resistance in type 2 diabetes~     patient will be assessed.~   "
10081|NCT03434847|"~     Prospective, randomized, single-blind study, whether perioperative educational improves~     pain-related postoperative outcomes,~   "
10082|NCT03434834|"~     This is a pilot study to test a newly developed optical coherence tomography (OCT) device to~     determine 1) whether adequate tissue contact can be attained to acquire high quality images,~     and 2) to identify if these images can discern whether the imaged tissue is squamous or~     Barrett's Esophagus (BE) epithelium.~   "
10083|NCT03434821|"~     The aim of this prospective cohort single-center observational study is to determine the~     impact of hyperoxemia on ventilator-associated pneumonia (VAP) occurrence.~        -  SpO2 will be continuously recorded in order to determine the percentage of time spent~          with hyperoxemia.~        -  Patients with VAP will be prospectively identified.~        -  Patient characteristics and risk factors for VAP will be prospectively collected.~        -  Oxidant stress will be prospectively investigated in study patients: glutathion~          peroxidase (GPX), plasmatic superoxyde dismutase (SOD), total plasmatic antioxidant~          status (SAT) and urinary 8-isoprostanes will be performed at ICU admission, once a week,~          and at VAP occurrence.~      Patients with VAP will be compared with those with no VAP~   "
10084|NCT03434808|"~     The purpose of this study is to develop a collection of iPS cells called a bank (Bank) that~     are immune-matched to a large percentage of the US population by containing the most common~     HLA haplotypes in the US population.~   "
10085|NCT03434795|"~     Evaluate the reproducibility and validate a posteriori a new rule of clinical decision on a~     multi-center population of children with a post-chemotherapy febrile neutropenia~   "
10086|NCT03434782|"~     To investigate the effects of desensitizing agents on the dental bleaching process, testing~     the hypothesis that they may control dental sensitivity.~   "
10087|NCT03434769|"~     The purpose of this study is to determine if it is possible to treat your cancer with a new~     type of T cell-based immunotherapy (therapy that uses your immune system to treat the~     cancer). T cells are a type of white blood cell that helps the body fight infections. This~     treatment uses T cells already present within your body that have been modified outside of~     the body and returned to target your cancer. This type of treatment is sometimes referred to~     as adoptive cell transfer (ACT). In this study the specific type of cells that will be used~     is called chimeric antigen receptor T cells (CAR T cells). Another purpose of this study is~     to learn about the side effects and toxicities related to this treatment.~   "
10088|NCT03434756|"~     The aim of the study will be tried to observe if the propioceptive Stabilizer training is~     effective in abdominal wall muscles in healthy subjects. All the participants will be~     examined in two times. Initially, baseline measurements with ultrasound imaging will be taken~     without muscle activity. After, they will do the abdominal manoeuvre and it will take the~     ultrasound images.~   "
10089|NCT03434743|"~     The main objective of this study is to assess whether non-nutritive sucking on an emptied~     breast will lead to more success with direct breastfeeding than non-nutritive sucking on a~     pacifier in preterm infants.~   "
10090|NCT03434730|"~     The aim of the research in this study is to make participants' transplant safer by reducing~     the risk of developing GVHD and GVHD-related complications by giving participants a dose of~     the drug tocilizumab in addition to the standard approach for GVHD prevention. Tocilizumab~     reduces the risk of inflammation by blocking the effect of Interleukin-6, a protein that~     exists in high levels in the blood when there is inflammation. Participants who receive stem~     cell transplants have high levels of this protein in their blood early after transplant.~     Therefore, the goal of this study is to reduce the risk of inflammation after transplant with~     the addition of Tocilizumab. This could decrease the risk of developing GVHD and~     GVHD-associated complications.~   "
10091|NCT03434717|"~     This study aims to evaluate the effects of an intervention based on systematic screening of~     psychological distress as the basis for individualised support and rehabilitation following~     primary breast cancer surgery focusing on psychological , physical and health-economics~     outcomes. The aim is also to illuminate patients' and relatives' experiences and need of~     support during the rehabilitation .~   "
10092|NCT03434704|"~     SIR-POSA is a phase II trial of peripheral blood stem cell (PBSC) transplantation from a~     partially compatible family (Haplo) donor in patients with a blood tumor (myelodysplastic~     syndrome (MDS) and acute leukemia) treated for the prevention of primary fungal infections~     with posaconazole.~      The aim is evaluate the composite end-point graft-versus-host disease-free, relapse-free~     survival (GRFS) in these patients and evaluate the feasibility and efficacy of posaconazole~     oral tablets as primary antifungal prophylaxis.~   "
10093|NCT03434691|"~     To investigate changes in the concentration of glucose, lactate, pyruvate and glycerol in the~     extracellular fluid of the skeletal muscle following Dexmedetomidine administration in~     patients with septic shock.~   "
10094|NCT03434678|"~     The purpose of this study is to see if there is a difference in complications in patients who~     have an epidural started earlier (during their surgery) and used as part of the anesthetic in~     addition to using it for post operative pain compared with patients who receive an epidural~     later in the surgery to be used only for post operative pain.~   "
10095|NCT03434665|"~     BACKGROUND:~        -  Obesity, with its associated comorbidities, is set to become a major risk factor for~          cardiovascular disease in the 21st century. To this day, diet and medical therapy have~          proven only limited efficacy and bariatric surgery remains the last resort for many~          severely obese patients who wish to lose weight, modify their cardiovascular risk~          factors and ultimately modify their long-term prognosis. However, bariatric surgery~          remains associated with significant procedural morbidity and many patients are not~          eligible for such a surgery procedure as the risk-benefit ratio of bariatric surgery in~          severe obese patients with coronary artery disease is not yet well known.~        -  Recently, percutaneous left gastric artery embolization has been reported as a promising~          technique leading to a body weight loss that is equivalent to bariatric surgery.~        -  In the context of an endovascular procedure in obese patients, vascular access is a~          major concern. Transradial access (or radial artery approach) has been consistently~          associated with significant reductions in access-site related vascular complications and~          peri-procedural bleeding compared to the standard transfemoral access (or femoral artery~          approach). This is particularly evident in patients with severe obesity.~        -  Visceral arteries most often have an acute angulation with the aorta which makes them~          more easily cannulated from above (transradial access) compared to below (transfemoral~          access). Preliminary experience has shown that cannulation of the celiac artery is~          feasible from transfemoral and transradial access, the latter being associated with~          shorter procedural time and less contrast agent use. To date, several pilot studies have~          reported successful percutaneous embolization of the left gastric artery with~          biodegradable microspheres. This appears to be a promising technique to reduce weight in~          severely obese patients.~        -  Prior to launching a randomized trial, further study is warranted regarding the~          feasibility and safety aspects of transradial angiography of the celiac artery.~   "
10096|NCT03434652|"~     This study evaluates the efficacy of auricular neurostimulation via an non-invasive~     percutaneous electrical nerve field stimulator in children and adults with cyclic vomiting~     syndrome.~   "
10097|NCT03434639|"~     Leaky gut - or, increased permeability of the intestine - involves the leakage of bacteria~     from the intestine (gut) into the rest of the body and causes serious and repeated~     infections. This condition is associated with many widespread diseases including coeliac~     disease, inflammatory bowel disease, HIV, liver cirrhosis and environmental enteric~     dysfunction (EED). It has a considerable impact on quality of life and, in extreme cases, can~     lead to death. Furthermore, in the developing world (as part of EED), it severely hampers the~     mental and physical development of young children. Thus, new devices that can help us to~     learn more about leaky gut and more accurately monitor its effects are urgently needed.~      To address this issue, this research aims to develop portable devices - known as fluorescence~     spectrometers - to monitor the leakage of fluorescent dyes out of the gut into the blood~     stream. These devices will measure the leakiness (permeability) of the gut in a non-invasive~     manner and will provide an early warning that patients are at risk of infections caused by~     the unwanted flow of bacteria from the intestine to the rest of the body.~      In this project, patients will drink a small dose of a fluorescent dye. Then, by shining~     light on the patients' skin and recording the color and brightness of the light~     (fluorescence) that comes back, it will be possible to measure the amount of dye that has~     leaked into the blood (indicating the likelihood that bacteria are escaping from the gut and~     causing infections). We refer to this as a Spectroscopic gut permeability test. We will~     also ask patients to take a traditional permeability test (known as a PEG permeability test)~     so that we can validate our new sensor. Overall, this research will deliver vital information~     that will improve our understanding of leaky gut and help guide the development of treatments~     for the many diseases in which it occurs.~   "
10098|NCT03434626|"~     Sometimes people with health conditions become ill suddenly and can no longer speak for~     themselves and another person (such as a family member) will make health care decisions for~     them. This means it is important for people to think about their wishes and tell others about~     them. This is called advance care planning. When people have done advance care planning, if~     they become very sick and cannot speak for themselves they are more likely to get the kind of~     health care they want and it is easier for the people who make decisions for them. In Alberta~     there is a form in the health care system that is used to indicate a person's wishes if~     participants are unable to speak for themselves. It is best to fill out the Goal of Care~     Designation form after a person has thought about what is most important to them and when~     they understand some of the possible decisions. There are tools such as brochures,~     questionnaires, and videos that can help participants learn about these things. This research~     is being done to study whether using tools for advance care planning and goals of care~     discussions will increase the number of patients that have their wishes documented in their~     medical record. The research is also being done to study whether the tools help patients~     understand what is most important to them and help them make the best decisions. This study~     is evaluating whether patients who meet with an advance care planning navigator to learn~     about advance care planning and use a decision aid are more likely to complete a goals of~     care form than patients who receive usual care.~   "
10099|NCT03434613|"~     To investigate the therapeutic effect of ezetimibe on nonalcoholic fatty liver disease, the~     effect of rosuvastatin 5mg monotherapy and rosuvastatin 5mg / ezetimibe 10mg combination~     therapy n patients with hyperlipidemia and fatty liver will be compared and analyzed.~      This study included a total of 70 patients (35 per subgroup) for randomized controlled trials~     with prospective, open label, randomized, single-institution clinical trials.~      The drug will be maintained for a total of six months. The primary endpoint is the difference~     of liver fat change measured by MRI-PDFF in colocalized regions of interest within nine liver~     segments between two groups.~   "
10100|NCT03434600|"~     Comparison of two unicompartmental knee arthroplasties (UKA), to see if Sigma UKA performs~     equally good as the Oxford UKA. The study focuses on how well the arthroplasty is fixated to~     the bone and on the difference in wear of the plastic insert. Finally, the functional outcome~     after surgery is compared between the two arthroplasties.~      Hypothesis:~      H1: The Sigma UKA has an equal migration pattern compared to the Oxford UKA with a follow up~     of two years - that is, no significant difference in migration between 1-2 years follow-up.~      H2: The Oxford and Sigma UKA's have comparable polyethylene wear with a follow up of 5 years.~      H3: The Oxford and Sigma UKA's have comparable patient perceived outcome measures (PROM) and~     leg extension power (LEP) postoperative.~   "
10101|NCT03434587|"~     This study aims to compare the functional results of two different therapeutic approaches in~     patients that present with a 5th metacarpal neck fracture. Patients will be randomly assigned~     to be treated with either syndactyly or closed reduction plus inmovilization.~   "
10102|NCT03434574|"~     Aronia berries are a native North American berry with high naturally occurring anthocyanins~     among other polyphenols. Based on their polyphenol composition, there is growing interest in~     the potential for Aronia berries to elicit health promoting cardio-metabolic effects.~     Specifically, Aronia berry extracts, which provide a concentrated source of polyphenols, may~     improve blood vessel function.~      Thus, the primary focus of this project is to evaluate the effects of Aronia berry~     polyphenols on blood pressure and other biomarkers of cardiovascular disease risk such as~     endothelial function, arterial stiffness and blood lipids.~   "
10302|NCT03431961|"~     Subjects with allergic asthma developing the required nasal symptoms in response to nasal~     allergen titration during a screening period will be randomized 1:1 to one of 2 cohorts. All~     subjects will have repeated nasal challenges with allergen. One cohort will have nasal saline~     challenge as control. One cohort will have intranasal corticosteroid intervention.~   "
10103|NCT03434561|"~     Comorbidity assessment in the field of HCT might be a burden on the medical team at the~     clinic or the research staff. This research study aims to explore and validate new methods,~     Claims-based and patient questionnaire-based, as alternatives to the standard chart-based~     method in order to facilitate comorbidity coding. The study aims to save time and effort of~     medical personnel and to ensure the inclusion of comorbidity information in all clinical~     trials and outcome research studies in order to improve the accuracy of treatment~     decision-making, patient assignment to appropriate HCT strategy and hence HCT outcomes.~   "
10104|NCT03434548|"~     iMarkHD is an innovative clinical imaging study and collaboration between the CHDI Foundation~     and Professor Marios Politis from King's College London (KCL) designed to assess longitudinal~     change in Huntington's disease (HD) pathology with positron emission tomography (PET)~     molecular and multi-modal magnetic resonance (MR) imaging, and clinical observation for up to~     three years.~   "
10105|NCT03434535|"~     The purpose of this study is to determine the feasibility of using digital technology and~     remote monitoring to track health-related measures in men following prostate cancer~     treatment. Half of the participants will receive tools to monitor their activity and weight,~     as well as personalized feedback on these measures, while the other half will receive~     standard of care. Health related quality of life measure will be collected from both groups.~   "
10106|NCT03434522|"~     This is a prospective, observational, case series registry which will collect information~     pertaining to experiences and health economics in individuals implanted with vBloc Therapy~     who are conjunctively using a weight management program. Subjects will be followed for 12~     months after implant.~   "
10107|NCT03434509|"~     Attention Deficit Hyperactivity Disorder (ADHD) has tremendous individual and societal~     impact, and the effectiveness of current standard treatments is limited. Thus, there are~     potential public health benefits for novel behavioral training programs that could remediate~     the core features of ADHD and contribute to sustained improvements in behavioral control.~     There is mounting evidence that children with ADHD show difficulties with motor control, and~     that these motor deficits are strongly associated with the core behavioral features of ADHD.~     Based on this information, the CNIR initiated a feasibility trial of a movement-based~     intervention, utilizing Tai Chi practice, targeting improved behavioral control through~     engagement of the motor system and results are highly promising. The investigators therefore~     will employ an extension of our ongoing Tai Chi programs for children with ADHD, beginning~     with children who have already completed one of the previous Tai Chi sessions. This program~     will provide the basis for studying the long-term effects of mindful movement, as well as~     creating a foundation for exploring the way that such interventions can be expanded into a~     more realistic support setting for the community.~      Hypothesis: After participating in the ongoing Tai Chi program, children with ADHD will show~     improvements in behavioral measures of motor, cognitive, and attentional control. The~     investigators further expect movement-based training will result in decreases in ADHD symptom~     severity.~   "
10108|NCT03434496|"~     Neurologic Music Therapy (NMT) sensorimotor techniques are increasingly used to improve~     spatio-temporal gait parameters and postural stability in the course of Parkinson's Disease~     and following stroke. Nonetheless, the neurophysiological underpinnings of NMT-mediated gait~     recovery is still poorly understood.~      The aim of the study was to investigate the central mechanisms of connectivity related to the~     application of Rhythmic Auditory Stimulation (RAS) in PD gait rehabilitation. The~     investigators will enroll 30 patients with PD. They will be randomized into two groups: (A)~     gait training with Music; (B) conventional treadmill gait training. The experimental group~     will perform training by means of GT3 (Biodex), where the patient is able to walk (on a~     treadmill) following specific musical beets and rhythms. The control group will perform only~     gait treadmill training.~      Subjects will attend 3 sessions a week for at least 4 weeks. Each session will last 45-min.~   "
10109|NCT03434483|"~     Cardiovascular diseases are the main cause of death in industrialized countries. Among them,~     atherosclerosis has the highest prevalence and constitutes a common pathological pathway~     responsible for the majority of cases of chronic ischemic heart disease, acute myocardial~     infarction, heart failure and cerebrovascular disease. Classic studies have confirmed~     well-established etiopathogenic factors of atherosclerosis based on genetic and immunological~     components and environmental modifying agents such as diet and exercise. But in addition,~     recent experimental studies have shown that dysbiosis (alteration of the microbiota) may be~     an additional factor that participates in the onset and progression of atherosclerosis. The~     objective of this study is to identify the potential interactions between changes in the~     microbiota, changes in the immune status, and the instability and progression of~     atherosclerosis.~   "
10110|NCT03434470|"~     According to the guidelines for treating hepatitis C livers stiffness (LS) measurement is~     equivalent to liver biopsy to prove grade-2 fibrosis or more by Metavir-score. Also flares of~     inflammation in other viral hepatitis (B) have been reported to increase the elastography~     measurements. There are very few reports so far on longitudinal data in a treatment cohort.~     In this study investigators will follow patients who undergo active treatment for hepatitis C~     virus (HCV). Investigators will collect longitudinal data of liver elastography and compare~     this to the current status of liver inflammation by blood samples. This may be important in~     order to know if transcutaneous US with elastography can be used as a tool to monitor active~     inflammation in liver disease and to quantify how much the inflammatory component contribute~     to LS and finally if it is possible to reverse not only inflammation but also liver fibrosis~     by treating viral hepatitis. Our aim is to assess shear wave elastography (SWE) and~     investigate if the method can be used, not only to define the indication for treatment~     through LS measurements, but also if LS due to inflammation and fibrosis may be reversible in~     treated patients. To investigate what role frequency of measurement obtains in follow up of~     patients with HCV play.~   "
10111|NCT03434457|"~     Maternal Adversity Vulnerability and Neurodevelopment (MAVAN) project is a prospective~     community-based, pregnancy and birth cohort of Canadian mother-child dyads. The main~     objective of MAVAN project is to examine the pre- and postnatal influences, and their~     interaction, in determining individual differences in children development. The MAVAN project~     is designed to examine the consequences of fetal adversity as a function of the quality of~     the postnatal environment, focusing on mother-infant interactions.~   "
10112|NCT03434444|"~     The rates of cesarean deliveries (CD) and postpartum hemorrhage (PPH) are on the rise, with~     failed induction and augmentation of labor as major contributing factors. Oxytocin is~     commonly used for labor induction, as well as during the third stage of labor to minimize the~     risk of primary PPH. At delivery, it is imperative that the uterus responds effectively to~     parenteral oxytocin. Poor response to oxytocin following delivery is commonly due to~     prolonged labor with oxytocin augmentation that is known to desensitize the myometrium.~     Despite the option of several second line uterotonic agents, none of them are as effective as~     oxytocin in controlling PPH. Given that poor uterine muscle contraction is the root cause of~     both failed induction or augmentation (leading to a CD in labor) and uterine atony (leading~     to PPH), there is an urgent and clinically important need to investigate novel methods to~     enhance oxytocin-induced myometrial contractions.~      Propranolol, a beta adrenergic receptor agonist, has the potential to improve myometrial~     contractions by virtue of its ability to inhibit catecholamine production. The investigators~     plan to investigate the effects of propranolol in both naive and desensitized myometrium, in~     order to better understand its potential role in improving labor induction and reducing the~     risk of PPH following oxytocin exposure during labor.~      The investigators hypothesize that propranolol is likely to potentiate the action of oxytocin~     upon human myometrium, to ultimately help improve the success of labor induction/augmentation~     and treatment of PPH.~   "
10113|NCT03434431|"~     Introduction: It is known that weight loss results in decreased Resting Energy Expenditure~     (REE), due to a decrease in lean body mass (LBM), but also due to metabolic adaptation,~     resulting in a higher energy efficiency, responsible for weight regain. Powerlifting athletes~     submit themselves to caloric restriction before a competition to reach their desired weight~     category. After cessation of the restrictive diet body mass will quickly return to pre-diet~     values with a disproportionate gain of fat mass. To avoid fat gain 'reversed dieting' has~     become popular among athletes. This involves increasing caloric intake in a stepwise fashion~     with the assumption that the small increases in caloric intake might help to restore energy~     expenditure toward pre-dieting levels and decrease the chance of increasing fat mass. While~     anecdotal reports of successful reverse dieting are available, research is needed to evaluate~     its true efficacy. In addition, if the method would work in non-athletes this could be an~     important change in the risk of weight regain after a weight loss diet. .~      Aim: To test the effects of the reverse dieting protocol in the prevention of metabolic~     adaptation following a period of caloric restriction in weight training athletes. .~      Methods: A convenience sample of 3 powerlifters is used in this study. They are submitted to~     a 750kcal/day caloric deficit with a protein intake set at 2x bodyweight (kg) and 30%en from~     fat for 6 weeks, adjusted weekly. The reverse dieting protocol adds 100kcal during week 1-4~     and 150kcal during week 5-8. REE is measured bi-weekly and body composition at day 1 of~     caloric restriction and day 1 and day 56 of reverse dieting. Exercise is kept constant during~     the entire period. .~   "
10114|NCT03434418|"~     This is a research study to find out if a drug called, osimertinib, is safe and effective in~     treating advanced Non-Small Cell Lung Cancer (NSCLC) by targeting the treatment of epidermal~     growth factor receptor (EGFR) mutation exon 18 G719X, exon 20 S7681, or exon 21 L861Q.~     Patients on the study will not have had previous tyrosine kinase inhibitor (TKI) treatment.~   "
10115|NCT03434405|"~     The current investigation has been designed to test the feasibility of a mindfulness-based~     social cognition training (SocialMind) for people with a first episode of psychosis~     (AGES-Mind Study, NCT03309475). The intervention has been designed by professionals with both~     formal training and clinical experience in the field of mindfulness and third generation~     cognitive-behavioral therapies. Main outcomes are recruitment rate, adverse events and~     treatment adherence, although therapy effects and adjustment to intervention manual are also~     explored.~   "
10116|NCT03434392|"~     Quantitative Sensory Testing (QST) is a novel investigative technique used in other pain~     conditions to evaluate patterns of chronic pain, and in this study will be used to elucidate~     pain patterns in patients with Chronic Pancreatitis (CP). QST uses a specific series of~     standardized stimulations to map the pain system. QST has the potential to change and improve~     the treatment paradigm for patients with CP and may eventually be able to predict response to~     invasive CP therapies.~   "
10117|NCT03434379|"~     This study will evaluate the efficacy and safety of atezolizumab in combination with~     bevacizumab compared with sorafenib in participants with locally advanced or metastatic~     Hepatocellular Carcinoma (HCC) who have received no prior systemic treatment.~   "
10118|NCT03434366|"~     Autism spectrum disorder (ASD) is a life-long neurodevelopmental disorder characterized by~     qualitative abnormalities in reciprocal social interactions and patterns of communication,~     and by a restricted, stereotyped, repetitive repertoire of interests and activities. The use~     of medications in adolescents and young adults with ASD is extremely common. However, few~     data address the effectiveness and harms of medications specifically in this population.~      The purpose of the study is to determine the efficacy and safety of intranasal ketamine with~     dexmedetomidine in children with ASD.~   "
10119|NCT03434353|"~     The primary objectives of this study are to evaluate the antiviral activity, safety and~     tolerability of 12 weeks of GS-9992 plus tenofovir alafenamide (TAF) versus TAF alone in~     adults with chronic hepatitis B (CHB).~      Participants will be randomized in a 3:1 ratio to Group 1 and Group 2. Group 3 is optional~     and may be enrolled based on emerging safety and efficacy data from ongoing Phase 2 study~     ACHIEVE (SB-9200-HBV-201; NCT02751996).~   "
10120|NCT03434340|"~     This study evaluates the effect of combining non pharmacological anti emetic prophylaxis,~     namely peppermint essential oil to granisetron and dexamethasone in patient who receive~     intrathecal morphine for lower segment cesarean section. Half of the patient will receive~     nasal strip containing peppermint essential oil in addition to granisetron and dexamethasone~     while the other half will only receive granisetron and dexamethasone.~   "
10121|NCT03434327|"~     The purpose of the current study is to compare the impacts of specifically designed power~     training and strength training programs on function and physical performance in Parkinson's~     patients. Specific aims are to examine the impact of these interventions on performance~     variables such as balance, strength, power, posture, gait and physical function.~   "
10303|NCT03431948|"~     Study to determine the best dose of stereotactic body radiation therapy (SBRT) to be~     administered in combination with immunotherapy drugs including urelumab, cabiralizumab and~     nivolumab .~   "
10122|NCT03434314|"~     Aortic aneurysms represent the most common and dangerous aortic diseases. Although~     conventional aortic repair techniques cure the disease, there is a high risk of paraplegia~     particularly in extensive thoracoabdominal aneurysms due to impaired blood supply to the~     spinal cord.~      The PAPA-ARTiS trial will assess the clinical safety and efficacy of the MISACE~     (Minimally-Invasive Segmental Artery Coil-Embolization) procedure, a novel therapeutic~     concept to reduce the risk of paraplegia due to aneurysm repair.~      The study investigates the MISACE procedure as a potential pre-treatment prior to open or~     endovascular aneurysm repair in patients with thoracoabdominal aortic aneurysms. Patients~     will be randomized to one of the two treatment strategies: a) aneurysm repair without MISACE~     pre-treatment, or b) aneurysm repair with MISACE pre-treatment.~   "
10123|NCT03434301|"~     This study is designed to examine the effects on post operative pain after the use of a~     fixation device to secure a mesh in the abdomen to repair a hernia of the abdominal wall. The~     fixation devices to be used differ with one being made from titanium and is permanent and the~     other being made from an absorbable material. Both fixation devices are commonly used but two~     questions remain unanswered, does one cause more chronic pain and also what if any will be~     the effect on recurrence rates of the hernia. No trial has been undertaken to date which will~     not only examine the fixation device but in the setting where the hernia is closed first. The~     closure of the hernial defect by the keyhole technique is a relatively new and growing~     concept in the hernia world.~   "
10124|NCT03434288|"~     Bone samples from infected diabetic feet will be collected and tests will be performed for~     the diagnosis of causative bacteria. Samples will be processed by PCR multiplex tests and~     usual cultures for identification of causative bacteria and sensitivity to antibiotics.~     Results obtained by the two methods will be compared in terms of quickness and similarity of~     germ identification. Usual care strategy will not be modified since results of PCR multiplex~     tests will not be transmitted to the physicians before the results of usual cultures.~   "
10125|NCT03434275|"~     The primary objective of this study is to assess the effect of preoperative administration of~     N1539 on opioid consumption in subjects undergoing open unilateral total knee arthroplasty~     compared to placebo.~   "
10126|NCT03434262|"~     Approximately 90% of children with malignant brain tumors that have recurred or relapsed~     after receiving conventional therapy will die of disease. Despite this terrible and~     frustrating outcome, continued treatment of this population remains fundamental to improving~     cure rates. Studying this relapsed population will help unearth clues to why conventional~     therapy fails and how cancers continue to resist modern advances. Moreover, improvements in~     the treatment of this relapsed population will lead to improvements in upfront therapy and~     reduce the chance of relapse for all. Novel therapy and, more importantly, novel approaches~     are sorely needed. This trial proposes a new approach that evaluates rational combination~     therapies of novel agents based on tumor type and molecular characteristics of these~     diseases. The investigators hypothesize that the use of two predictably active drugs (a~     doublet) will increase the chance of clinical efficacy. The purpose of this trial is to~     perform a limited dose escalation study of multiple doublets to evaluate the safety and~     tolerability of these combinations followed by a small expansion cohort to detect preliminary~     efficacy. In addition, a more extensive and robust molecular analysis of all the participant~     samples will be performed as part of the trial such that we can refine the molecular~     classification and better inform on potential response to therapy. In this manner the~     tolerability of combinations can be evaluated on a small but relevant population and the~     chance of detecting antitumor activity is potentially increased. Furthermore, the goal of the~     complementary molecular characterization will be to eventually match the therapy with better~     predictive biomarkers.~      PRIMARY OBJECTIVES:~        -  To determine the safety and tolerability and estimate the maximum tolerated~          dose/recommended phase 2 dose (MTD/RP2D) of combination treatment by stratum.~        -  To characterize the pharmacokinetics of combination treatment by stratum.~      SECONDARY OBJECTIVE:~        -  To estimate the rate and duration of objective response and progression free survival~          (PFS) by stratum.~   "
10127|NCT03434249|"~     This is a single-center, randomized, double blind controlled study to investigate the effects~     of Bifidobacterium, BB-12® versus placebo in a study group of pediatric patients with~     infantile colic.~   "
10128|NCT03434236|"~     The aim of this pilot study is to investigate whether pre-operative supplementation with an~     over the counter dietary supplement containing a fractionated marine lipid concentrate~     derived from anchovy and sardine oil, Lipinova® (Solutex), improves the inflammatory profile~     and proresolving capacity in patients undergoing total knee arthroplasty. In addition, the~     investigators will compare the ability of two different dosing regimens to maximize SPM~     (Specialized Proresolving Mediators) availability.~   "
10129|NCT03434223|"~     Establish a data repository of patients who have undergone single, two-, or three-level~     lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz System.~   "
10130|NCT03434210|"~     This is a 49 weeks open-label randomized controlled study. Patients with schizophrenia and~     violence risk will be enrolled in the study. A community-based long-acting~     antipsychotics-treated management model will be applied to the experimental group, which~     means that professional psychiatrists will provide guidance to primary-level mental health~     workers on the psychotic treatment, and monthly-injected long-acting antipsychotic,~     paliperidone palmitate, will be used in the schizophrenia treatment. Subjects in control~     group will be treated and cared as usual.~   "
10131|NCT03434197|"~     The objectives of this study are to demonstrate the non-inferiority of esflurbiprofen plaster~     (SFPP) 40 mg applied for 2 weeks to diclofenac gel, the comparator, in terms of efficacy in~     patients with knee osteoarthritis (OA) and to examine the safety of SFPP.~   "
10132|NCT03434184|"~     The purpose of this study is to determine the effect of double end spinal instrumentation~     from the upper thoracic to the pelvis with sacro-iliac ﬁxation on the gait of ambulating~     patients suffering from cerebral palsy with pelvic obliquity 6 month after surgery.~   "
10133|NCT03434171|"~     50 menopausal women with the diagnosis of hot flushes were randomized to 1 of 2 groups~      Group (A):~      It consists of 25 women who practiced treadmill exercise program for 30 minutes at 60% to 70%~     of maximum heart rate. The treatment sessions will be repeated 3 times per week for 12 weeks.~      Group (B):~      It consists of 25 women who received diet modification contains soy products (phytoestrogen)~     such as soy milk and soy beans every day for 12 weeks only.~   "
10141|NCT03434067|"~     The half-life of the parathyroid hormone is about 4min, blood pth test is use in operation to~     confirm that parathyroid tumor is removed. but the blood pth test is time consuming and~     unpractical in most of hospital. this study will compare the application of rapid PTH test~     paper in operation of hyperparathyroidism.PTH test were measured in operation in different~     way. it will test at the time of preoperation, 15 minutes after surgery, 1 hour after surgery~     and 24 hours after surgery. thus evaluate the reliability and accuracy of PTH test paper in~     evaluating the Miami principles with the linear relation of blood PTH and the PTH test paper~     method.~   "
10134|NCT03434158|"~     A number of important systemic therapies have been developed to treat mCRPC and have received~     regulatory approval and now comprise the current therapeutic landscape. Durable and complete~     response following first-line chemotherapy in patients with advanced PC are uncommon. Most~     patients will ultimately experience disease progression within 6-9 months after initial~     response. Optimal Second line therapy in mCRPC is not well established and several options~     are possible.~      Olaparib has demonstrated anti-tumour activity in non-comparative studies in patients with~     germline BReast CAncer gene (gBRCA) mutated cancers including ovarian, breast, pancreas and~     prostate. Olaparib is indicated as monotherapy for the maintenance treatment of adult~     patients with platinum-sensitive relapsed Breast Cancer gene-mutated (germline and/or~     somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer~     who are in response (complete response or partial response) to platinum-based chemotherapy.~      This phase II study is developed to assess the effect of maintenance treatment with olaparib~     on radiologic progression free survival (rPFS) in patients with mCRPC who have received at~     least 6 cycles of docetaxel and achieved partial or complete response or disease~     stabilization according RECIST 1.1 criteria and PCWG3.~   "
10135|NCT03434145|"~     To evaluate the effect of hemodialysis on various ophthalmologic parameters in patients with~     end-stage kidney disease (ESRD).~   "
10136|NCT03434132|"~     This prospective randomized study is designed to provide high level of evidence supporting~     superiority of robot assisted (RA) versus open (O) radical cystectomy (RC). The primary~     endpoint is a 50% reduction of transfusion rate, several perioperative outcomes potentially~     linked to a reduced invasiveness are considered as secondary endpoints. Investigators~     hypothesis is that the reduced invasiveness of RARC might turn into a higher adherence to~     enhanced recovery after surgery (ERAS) protocols (early bowel recovery, reduced need for~     painkillers and insertion of nasogastric tube) and consequently to shorter hospital stay and~     to faster return to daily activities. These data will be taken into account in a matched cost~     analysis between arms. Secondary aims include a between arm matched comparison of~     perioperative complications, oncologic outcomes (2-yr disease free survival is an accepted~     surrogate of long term oncologic effectiveness of RC) and functional outcomes (daytime and~     nighttime continence).~   "
10137|NCT03434119|"~     Primary Objective:~        -  To demonstrate the superiority of Soliqua 100/33 versus Lantus in the hemoglobin A1c~          (HbA1c) change within the overall population.~        -  To demonstrate the benefit of Soliqua 100/33 versus Lantus in the HbA1c within each~          ethnic/racial subgroup evaluated (ie, Hispanics of any race, non-Hispanic black/African~          Americans and non-Hispanic Asians).~      Secondary Objective:~        -  To assess the effects of Soliqua 100/33 versus Lantus on the secondary efficacy~          parameters within each ethnic/racial subgroup evaluated.~        -  To assess the change in daily insulin glargine dose within each ethnic/racial subgroup.~        -  To evaluate the safety and tolerability (e.g., gastrointestinal tolerability) of Soliqua~          100/33 versus Lantus within each ethnic/racial subgroup.~   "
10138|NCT03434106|"~     The investigators hypothesize that the dry eye caused by SS may include the evaporative type,~     resulting from the MGD. Furthermore, the investigators hypothesize that both pSS and sSS are~     associated with MGD.To test our hypothesis, we conducted a prospective clinical study in~     patients with SS (both pSS and sSS) and MGD, and the normal population All subjects were~     matched for both age and gender and assessed for tear function and ocular surface signs and~     symptoms.~   "
10139|NCT03434093|"~     Background:~      Research shows that the parietal and prefrontal areas of the brain are involved in short-term~     memory. Researchers want to look at the effects of transcranial magnetic stimulation (TMS) of~     these areas on short-term memory and brain activity. They will use functional magnetic~     resonance imaging (fMRI) to look at brain activity.~      Objective:~      To look at the effects of TMS on brain pathways involved in memory.~      Eligibility:~      Healthy, right-handed adults ages 18-50~      Design:~      Participants will have 3 or 4 visits at least 1 week apart. They cannot drink alcohol for at~     least 48 hours before each visit.~      The screening visit lasts about 1 (Omega) hours. It can be combined with the first testing~     visit. Screening includes:~        -  Medical history~        -  Physical exam~        -  Neurological exam~        -  Urine tests~        -  Questionnaires about being left or right handed and about their ability to imagine~          physical activities.~      The first testing visit lasts about 1 (Omega) hours and includes an MRI. For the MRI,~     participants lie on a table that slides into a machine. They will lie still or perform simple~     memory tasks on a computer screen.~      The second and third testing visits last about 3 hours. Participants will have:~        -  2 MRIs~        -  TMS: A wire coil is held to the scalp. A brief electrical current passes through the~          coil to create a magnetic pulse that affects brain activity. They will perform simple~          memory tasks.~        -  EMG: Small electrodes are taped to the skin to record muscle activity while they rest.~      After the study, participants will complete a questionnaire about any discomfort they~     experienced during the study.~   "
10140|NCT03434080|"~     Background:~      New ways to study the brain as people move include near-infrared spectroscopy (NIRS) and~     electroencephalography (EEG). NIRS uses laser light shone through the scalp to look at blood~     flow in the brain which increases with movement. EEG records electrical activity in the~     brain. Little is known about brain activity while children learn new motor skills.~     Researchers want to learn more about how small children with and without cerebral palsy use~     their brain to control their body. This may help them find new ways to help children move~     better.~      Objectives:~      To learn more about how infants and young children with and without cerebral palsy use their~     brain to move their arms and legs.~      Eligibility:~      Children ages 3 months - 5 years with and without cerebral palsy~      Design:~      Participants will be screened with:~        -  Physical exam~        -  Questions for the parents about the child s health~      Participants will have at least 1 study session. Some may have up to 34 (all optional).~      In the sessions, participants will do motor tasks along with some or all of the following:~        -  Light sensors placed on the scalp, held there with a cap or Velcro straps.~        -  Small metal disks placed on the scalp with a cap or straps, with gel between them.~        -  Motion capture recording. Balls attached to the arms and legs by stickers, straps, or a~          garment are tracked by infrared and video cameras.~      Motor tasks include reaching, clapping, kicking, and standing.~      Participants may be placed in a toy or device that uses a motor to move their limbs.~      Participants head size, hair, and skin will be assessed.~      Parents will answer questions about their child s typical movements.~   "
10143|NCT03434041|"~     The purpose of this study is to evaluate the efficacy of switching adult participants with~     treatment-resistant depression (TRD) from a prior antidepressant treatment (to which they~     have not responded) to flexibly dosed intranasal esketamine (56 milligram [mg] or 84 mg) plus~     a newly initiated oral antidepressant compared with switching to a newly initiated oral~     antidepressant (active comparator) plus intranasal placebo, in improving depressive symptoms.~     Efficacy will be assessed by the change from baseline in the Montgomery Asberg Depression~     Rating Scale (MADRS) total score from Day 1 (before randomization) to the end of the 4-week~     double-blind treatment phase.~   "
10144|NCT03434028|"~     Multicenter, prospective, phase 3 randomized non-blinded interventional trial of fluid~     treatment strategies in the first 24 hours for patients with sepsis-induced hypotension. The~     aim of the study is to determine the impact of a restrictive fluids strategy (vasopressors~     first followed by rescue fluids) as compared to a liberal fluid strategy (fluids first~     followed by rescue vasopressors) on 90-day in-hospital mortality in patients with~     sepsis-induced hypotension.~   "
10145|NCT03434015|"~     Patients with atrial fibrillation are at significant risk of thrombus formation in the left~     atrial appendage, which can lead to a stroke or systemic embolism. This risk justifies~     first-line prescribing of long-term oral anticoagulant therapy in these patients.~     Percutaneous left atrial appendage closure, is a new interventional cardiology technique for~     patients at high risk of stroke related to atrial fibrillation in whom long term~     anticoagulation therapy cannot be conducted. This procedure involves implantation of an~     occlusion device into the left atrial appendage to close it and prevent migration of~     thrombotic material that can cause distant embolism. Closure of the left atrial appendage~     avoids long term prescription of anticoagulants while protecting patients against the risk of~     systemic embolism and stroke. In 2016, two devices developed for transcutaneous closure of~     the left atrial appendage (WATCHMAN, Boston Scientific, AMPLATZER CARDIAC PLUG, S. Jude~     Medical and its evolution AMPLATZER AMULET) were included in the list of products~     reimbursable in France. The French national authorities have requested the realization of a~     register whose objectives will be to evaluate:~        -  The efficiency and safety of implanting devices in France~        -  The type and duration of antithrombotic treatment prescribed after left atrial appendage~          closure~   "
10146|NCT03434002|"~     In this study, Investigators are going to develop and test a device to apply virtual reality~     simulation to improve and help for teaching and assessment of anesthesia crisis management.~   "
10147|NCT03433989|"~     In France The prevalence of Pregnancy Loss after 12 weeks of gestation is around 3%. This~     situation is probably associated to a risk of post-traumatic stress disorder.~      As a part of the medical staff midwives are often confronted with this situation, however~     they can have difficulties to identify short and long term effects of a post-traumatic stress~     disorders.~      The purpose of the present study is to estimate and analyze the prevalence of short-term (1~     month) post-traumatic stress disorder in women with pregnancy loss after 12 weeks of~     gestation.The symptoms of post-traumatic stress disorder will be tracked using the Impact of~     Event Scale-revisited and the Peritraumatic Dissociative Experiences Questionnaires.The~     diagnosis of post-traumatic stress disorder will also be clinically confirmed by a~     psychiatrist during a specific consultation.~   "
10148|NCT03433976|"~     The planned cesarean section is an intervention with a standard operating time of less than~     40 minutes in trained teams. Hyperbaric Bupivacaine is the local anesthetic (LA) reference~     for these operations. But the duration of its motor block is generally greater than 3 hours.~     The purpose of this study is to show a reduction in motor block time with hyperbaric~     Prilocaine by at least 30 minutes, which would allow mothers and their children to return to~     the maternity ward earlier and thus improve the circulation of patients within the~     maternity's PACU.~   "
10149|NCT03433963|"~     The present study is aimed to investigate whether oral L-arginine supplementation reduces the~     adverse cardiovascular effects of exposure to traffic-related air pollution among a group of~     non-smoking adults with elevated blood pressure.~   "
10150|NCT03433950|"~     Current management of hypertension in PD motor fluctuators is flawed. The current practice~     often is to treat transient hypertensive spikes reported by patients or measured in clinics~     with anti-hypertensive medications. This may contribute to morbidity by worsening orthostatic~     hypotension and increasing fall risk. There is a scarcity of literature on this subject and~     there is no documentation of severe hypertension with rises in systolic blood pressure~     exceeding 50% of baseline occurring during motor OFF. There are two studies that have~     demonstrated that blood pressure fluctuation can occur in motor fluctuators during the OFF~     state1,2. The study by Baratti et al measured blood pressure in 13 Parkinson's disease~     patients, 7 with motor fluctuations and 6 without fluctuations. In the fluctuators, the mean~     systolic/diastolic blood pressures were significantly higher than the non-fluctuators during~     the OFF state but not the ON state.~   "
10151|NCT03433937|"~     Inguinal lymph node dissection (ILND) is indicated following metastatic malignant melanoma,~     and is associated with a high-complication rate, of which many begin with the formation of~     seroma and ends in complicated wound healing, reoperation, multiple outpatient visits and~     re-hospitalization. Prevention of seroma may therefore lead to a reduction of many of the~     preceding complications and improve patient quality-of-life. The aim of this study is to~     evaluate the efficacy and oncological safety of prophylactic negative pressure wound therapy~     following ILND in melanoma patients.~   "
10152|NCT03433924|"~     The Primary Objective of this observational study is to investigate the prevalence of high~     PD-L1 expression in Chinese MIUBC patients.~   "
10153|NCT03433911|"~     Prospective, multi-center, international, non-randomized, two-arm study of subjects~     undergoing either FemBloc or laparoscopic bilateral tubal sterilization (Control). The~     FemBloc group total study duration will be approximately 65 months. The laparoscopic tubal~     sterilization (Control) group total study duration will be approximately 62 months.~   "
10363|NCT03431155|"~     The aim of this study is to determine the effect of nursing interventions based on Mishel's~     Uncertainty in Illness Theory on mothers', who have children with cancer, uncertainty,~     hopelessness, coping and compliance. Half of the mothers will receive nursing interventions~     based on Mishel's Uncertainty in Illness Theory while the other mother will receive routine~     nursing intervention of hospitals.~   "
10154|NCT03433898|"~     The main objectives of the BI 754091 monotherapy dose-finding part (Part I) of the trial are~     to investigate the following items in advanced solid tumours:~        -  Safety, tolerability, and pharmacokinetics (PK) of BI 754091 as monotherapy.~        -  Maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of BI 754091~          monotherapy.~      The main objectives of the Combination dose-finding part (Part II) of the trial are to~     investigate the following items in advanced solid tumours:~        -  Safety, tolerability, and PK of the combination treatment of BI 754091 and BI 754111.~        -  MTD and/or RP2D of the combination treatment of BI 754091 and BI 754111.~      The main objectives of the expansion part (Part III) of the trial are:~        -  To further investigate the safety, tolerability, and PK of the RP2D of BI 754091 and BI~          754111 combination in patients with gastric/esophagogastric junction cancer, esophageal~          cancer, or hepatocellular cancer~        -  To explore the efficacy of the RP2D of the combination of BI 754091 and BI 754111 in~          patients with gastric/esophagogastric junction cancer, esophageal cancer, or~          hepatocellular cancer~   "
10155|NCT03433885|"~     To evaluate the correlation between macular pigment optical density (MPOD) levels and risk of~     progression in patients with age-related macular degeneration~   "
10156|NCT03433872|"~     Mathematica Policy Research, funded by OPRE, ACF, DHHS, will conduct a field test of We Grow~     Together: The Q-CCIIT Professional Development System. These professional development (PD)~     tools and the interactive website featuring the materials were developed to promote~     high-quality caregiver-child interactions in non-parental care settings serving infants and~     toddlers. This field test aims to: (1) examine changes in caregiver practice that the~     investigators expect to be associated with use of the We Grow Together system, and (2)~     examine implementation of We Grow Together. As a secondary goal, the investigators will~     further evaluate the psychometrics of the Q-CCIIT observational measure of interaction~     quality.~      Collecting data from field test participants will occur from fall 2018 through spring 2019.~     First, the investigators plan to collect a background survey with caregivers and PD providers~     in fall 2018. Second, in fall 2018 and spring 2019 the investigators plan two rounds of~     classroom observations using the Q-CCIIT measure and classroom rosters. Third, the~     investigators plan to collect data on the use and implementation of We Grow Together through~     the interactive website from fall 2018 through spring 2019. Finally, the investigators plan~     to conduct a feedback survey with caregivers and PD providers in spring 2019.~   "
10157|NCT03433859|"~     The aim of this study is to demonstrate onabotulinumtoxinA superiority to aluminium chloride~     for the treatment of residual limb hyperhidrosis.~   "
10158|NCT03433846|"~     The aims of this study are to:~        -  Assess whether ex-preterm infants have a persistently immature immune system, which may~          decrease their ability to respond to infections, when they reach term-corrected~          gestational age.~        -  Examine whether clinical history, nutrition status, and microbiome composition are~          linked to the immune composition of term and ex-preterm infants and whether these~          variables can be used to predict the risk of developing sepsis. .~   "
10159|NCT03433833|"~     We propose a pilot clinical trial lasting 12 weeks of digoxin in patients with hypoxic~     response-related erythrocytosis. The complete blood count, safety, symptoms of headache and~     lack of energy, echocardiogram, physical performance, and plasma products blood cell~     expression of hypoxia inducible factor-1-regulated genes are the outcome variables. The~     enrolled patients will receive standard of care at the provider's and institutional~     preference. The patients will be studied at baseline, at two and four weeks and then at~     four-week intervals during treatment with digoxin.~   "
10160|NCT03433820|"~     The skin plays a critical role in protection where it acts as a barrier from damage and~     pathogens between the external and internal environments. Wounds compromise its protective~     role by disrupting the function and the normal structure of the skin and the underlying soft~     tissue. As a response to injury wound healing occurs in order to rapidly restore the defect.~     This process involves activation of keratinocytes, fibroblasts, endothelial cells,~     macrophages, and platelets and consists of multiple phases including hemostasis,~     inflammation, migration and cellular proliferation, and maturation and remodeling. A~     simplified schematic of the course of wound healing is depicted in Figure 2. Hemostasis~     occurs immediately after dermal injury. The inflammation phase is characterized by cellular~     recruitment and increased vascular permeability. The epithelization phase is achieved by~     proliferation of basal cells and migration of epithelial cells. The last phase is known as~     the maturation and remodeling phase where collagen cross-linking and remodeling, wound~     contraction, and repigmentation takes place. Due to the broad involvement of various cell~     types, extracellular matrix and many reactive molecules each phase in wound healing produces~     characteristic changes within the tissue. A deficiency in any part of the process can lead to~     delayed wound healing, abnormal scar formation or chronic wounds.~      To study wound healing in healthy volunteers a challenge model with skin punch biopsies has~     been described in literature previously. However, the characterization of this model was not~     performed comprehensively since advanced analysis of biopsies were omitted. Furthermore,~     analyses performed in previous studies only partially described wound healing processes~     either by insufficient time points for characterization or scarce simultaneous evaluations of~     multiple wound healing modalities.~      The overall aim of this study is to develop a standardized model to temporarily and locally~     induce a skin trauma to investigate wound healing and monitor wound closure. This clinical~     model will enable future application as proof-of-pharmacology and proof-of concept studies as~     well as drug profiling in early drug development programs. More specifically, the objective~     of the trial is to explore and characterize the induction of well-defined skin trauma and~     natural wound healing process over the course of the different phases using a battery of~     dermatological assessments after skin punch biopsies in healthy volunteers. Furthermore,~     safety and tolerability will be assessed.~      Characterization and monitoring of wound healing effects following skin punch biopsies will~     be performed by means of biophysical, biochemical, imaging, clinical parameters and subject~     reported outcomes.~   "
10161|NCT03433807|"~     The primary objective of this Expanded Access Program is to provide idebenone as a treatment~     for eligible participants with Duchenne Muscular Dystrophy before it is commercially~     available in the United States (U.S.) for the indication of DMD.~   "
10173|NCT03433651|"~     This study involves the use of an investigational drug called Creatine Monohydrate. This~     means that the drug has not yet been approved by the Food & Drug Administration (FDA) for~     treatment of altitude-induced depression. However, the FDA has not objected to its use to~     study its safety and effectiveness for preventing altitude-induced depression. This study~     will help find out what effects, good and/or bad, Creatine Monohydrate has on treating~     symptoms for altitude-induced depression. Creatine Monohydrate is believed to have an effect~     on improving symptoms of depression. The safety of Creatine Monohydrate in humans has been~     tested in prior research studies; however, some side effects may not yet be known.~   "
10174|NCT03433638|"~     This is a retrospective descriptive cross-sectional and observational multicenter clinical~     and progressive study of juvenile dermatomyositis. The aim is to determine the clinical,~     paraclinical, and evolutive characteristics and therapeutic modalities from a series of~     juvenile dermatomyositis identified in Alsace between 2000 to 2015.~   "
10162|NCT03433794|"~     Alcohol use among college students is both widespread and problematic. There are many~     negative consequences associated with frequent alcohol use, ranging from mild (e.g.,~     hangovers, missed classes) to severe (e.g., assault, even death). Online interventions~     targeting alcohol use among college students reduce alcohol consumption and associated~     problems. These interventions are popular among colleges because they are relatively~     inexpensive and easily disseminated. However, online interventions are not as efficacious as~     face-to-face interventions, such as brief motivational interviews. The proposed project~     employs emailed boosters in a randomized, controlled trial in an effort to improve the~     efficacy an existing, popular, free online intervention, while at the same time maintaining~     low cost and easy dissemination.~      Adding boosters after interventions is a common technique to improve the efficacy of the~     original intervention. Boosters have been used successfully for alcohol use interventions~     among those seeking injury treatment in emergency medical settings. However, prior research~     has not supported booster efficacy for college student alcohol interventions. The current~     project develops and evaluates the effectiveness of boosters for a widely-used college~     student alcohol intervention. Specifically, the present project improves boosters by~     providing easy access via email; providing succinct, personalized feedback; and providing~     reminders of protective behavioral strategies. To test the effectiveness of adding boosters,~     participants randomized to alcohol-intervention-plus-boosters receive emails 2 weeks after~     the intervention with tailored feedback based upon their reported alcohol consumption.~     Participants are assessed up to nine months. The current research addresses the following~     specific aims:~      Aim 1: Improve the efficacy of an easily-disseminated computerized intervention by adding~     personalized follow-up boosters, where efficacy is evidenced by reduced drinking and negative~     alcohol-related consequences (i.e., stronger effect sizes in the booster group immediately~     after receiving the booster).~      Aim 2: Extend the duration of the reduction in drinking and associated problems through the~     use of these personalized follow-up boosters (i.e., significant differences between the~     booster and control groups at later timepoints).~      Aim 3: Examine protective behavioral strategies highlighted by the booster as mediating~     behavioral mechanisms of change.~   "
10163|NCT03433781|"~     This is an open label, Phase Ib/IIa study designed to evaluate the safety, toxicity and~     biological activity of high dose Vitamin C in bone marrow and peripheral blood when~     administered as therapy to patients with intermediate or high risk myelodysplastic syndrome~     according to the revised IPSS (international prognostic scoring system) criteria whose~     disease has a Ten-eleven translocation-2, (TET2) mutation.~   "
10164|NCT03433768|"~     AR is a steroid hormone receptor that regulates various genes' expression and affects~     cellular proliferation and differentiation. Androgens interact with AR, exert their paracrine~     action on granulosa cells and regulate gonadotropin synthesis, follicle development, oocyte~     maturation and corpus luteum function. Estrogens increase AR mRNA and testosterone binding~     site in uterine endometrium and leiomyoma. In human cancer cells, low estradiol increases AR~     levels, suggesting the estrogen/androgen ratio as a predictor of sex steroid response. AR~     mRNA expression is, also, regulated by progesterone. Although AR mRNA is expressed in the~     female reproductive tissues, its expression has never been studied in peripheral blood.~   "
10165|NCT03433755|"~     This study is being done to learn more about evolocumab in Chinese people with primary~     hypercholesterolemia or mixed dyslipidemia. This study will see if evolocumab will reduce low~     density lipoprotein cholesterol (LDL-C) in Chinese people who are also taking a certain type~     of lipid-lowering medication (statins with or without ezetimibe) and whether it causes any~     side effects.~   "
10166|NCT03433742|"~     Metal Ions levels of cobalt, chromium, and titanium in 40 patients preoperatively and at~     least 1 year status post total hip replacement with the Trident II Tritatnium system using an~     MDM liner and ceramic head. Are cobalt, chromium, and titanium levels in patients who undergo~     a total hip replacement with a Trident II Tritanium system, MDM liner, and ceramic head~     normal one year after surgery? Investigators expect to find normal levels of metal ions~     (cobalt, chromium, and titanium) after total hip replacement using Trident II Tritanium cups~     with an MDM liner and a ceramic head. The primary outcome (PO) is blood metal ion levels of~     cobalt, chromium, and titanium (concentration of metal ions in blood). Blood will be drawn in~     the 3rd Floor West of the Main Building, and then tested for metal ions in the Hospital for~     Special Surgery laboratory. The bloods will be drawn at a preoperative visit and at a one~     year visit.~   "
10167|NCT03433729|"~     The purpose of the study is to determine whether patients who use a prompt sheet to identify~     their important issues before they see a doctor are more likely to feel that their important~     issues have been discussed during their consultation. The study will be conducted in a~     respiratory outpatient clinic.~   "
10168|NCT03433716|"~     Lateral epicondylitis (LE), also known as tennis elbow, refers to a painful condition at or~     around the lateral epicondyle of the humerus and common extensor tendon (CET) that is~     aggravated by dorsiflexion and/or supination of the wrist against resistance. Lateral~     epicondylitis is one of the most common injuries of the elbow, affecting 1-3% of the~     population.~      Therefore, determining an effective intervention that helps manage the condition and lessens~     the financial burden is important. Passive physical modalities, including electrotherapy and~     orthotic devices, are common treatments for the management of elbow pain. Passive physical~     modalities are physical treatments involving a device that does not require active~     participation by the patient. In a systematic review, 2017, Dion et al examined the~     effectiveness of passive physical modalities for the treatment of soft tissue injuries of the~     elbow, but little evidence exists to support or refute their use.~      Clinically, an invasive technique has appeared, known as Ultrasound-guided Percutaneous~     Neuromodulation (PNM). This minimally invasive intervention consists in the applicacion of a~     percutaneous electrical stimulation (PES) through an acupuncture needle-like electrode that~     is placed in close proximity to the nerve or motor point of the muscle with ultrasound~     guidance. At the clinical level, the PES is always used with the therapeutic aim of relieving~     chronic pain and neuropathic pain. Similarly, in sports, PES is used with the aim of~     improving muscular activity. Therefore, according to the characteristics and the therapeutic~     benefits of this technique, further research is needed to discover multiple clinical~     indications.~      The aim of this study was to examine the effects of a percutaneous neuromodulation~     intervention in patients with unilateral refractory lateral epicondylitis. Findings from this~     study may provide further evidence for the relevance of neural tissues in determining the~     elbow pain and may indicate effects of US-guided NMP technique on the rehabilitation and/or~     prevention of in patients with unilateral refractory LE.~   "
10169|NCT03433703|"~     The primary objective of this study is to assess the safety and tolerability of subsequent~     treatment of physician's choice (TPC) following the first-line lenvatinib treatment in~     unresectable hepatocellular carcinoma (uHCC) participants.~   "
10170|NCT03433690|"~     In this study the investigators wish to investigate whether a short duration High-intensity~     Interval Training(HIT) is superior to a moderate activity training modus with regards to~     improving weight-loss, Blood pressure and sleep quality in severely obese children and~     adolescents also receiving a multidisciplinary treatment regime.~   "
10171|NCT03433677|"~     The purpose of this study is to evaluate the compatibility and safety of LY900014 and insulin~     lispro with an external continuous subcutaneous insulin infusion system in adult participants~     with type 1 diabetes.~   "
10172|NCT03433664|"~     This study evaluates the effect effect of ablative fractional CO2 laser (AFCO2L) on burns~     scar appearance and dermal architecture at 6 weeks and up to 3-years post-treatment. Half of~     the scar will receive AFCO2L and half the scar will receive standard care.~   "
10202|NCT03433261|"~     The purpose of this research study is to understand the effect of nutritional ketosis on CNS~     oxygen toxicity in undersea divers. The investigators hope this will provide a starting point~     to develop methods for improving the safety of Navy divers, warfighters and submariners.~   "
10175|NCT03433625|"~     Generalized Anxiety Disorder (GAD) is a chronic condition that is characterized by excessive~     and uncontrollable worry and anxiety. In Canada, 3 to 4% of the population suffer from GAD at~     any point in time. These individuals have a lowered quality of life and are at risk for many~     medical conditions such as coronary heart disease and cancer. Research suggests that both~     pharmacological and psychological approaches are effective for treating GAD in the~     short-term; however, psychological treatments appear to offer the greatest long-term~     benefits. There exist a number of effective psychological treatments for GAD, most of which~     fall into the category of cognitive-behavioural therapy or CBT. In the 1990s, a group of~     Canadian investigators developed a CBT protocol for GAD that included four components. Data~     from five clinical trials suggest that one of the four components is particularly important~     for treatment success: experiencing uncertainty rather than avoiding it in everyday life.~     Stated differently, learning to tolerate and deal with uncertainty appears to be the key to~     decreasing worry and anxiety. Given this finding, the investigators have developed a new~     treatment that exclusively targets intolerance of uncertainty: Behavioural Experiments for~     Intolerance of Uncertainty or BE-IU. The goal of the current proposal is to test the efficacy~     of BE-IU (6 weekly treatment sessions) by comparing it to a Waiting List (WL) control~     condition (6 weeks). A total of 50 participants with a primary diagnosis of GAD will be~     randomly assigned to either BE-IU or WL and will be assessed at 4 time points ranging from~     pre-treatment to 12-month follow-up. The conditions will be compared in terms of treatment~     efficacy and mechanisms. The investigators will also examine the predictors of change during~     the 12-months following treatment. The proposed study will produce data on the efficacy and~     mechanisms of a treatment for GAD that is less costly, less complex and easier to disseminate~     than treatments that are currently available.~   "
10176|NCT03433612|"~     This study is a randomized clinical trial to evaluate the accuracy of the novel SAIL~     technique compared to the classic intercristal line technique in estimating the L4-L5~     interspace for labor epidural or spinal anesthesia placement. The investigators hypothesize~     that the SAIL technique will be more accurate in successfully locating the L4-L5 interspace~     in pregnant women than the classic intercristal line technique.~   "
10177|NCT03433599|"~     The overall objective of this project is to investigate the effectiveness of daily acute~     intermittent hypoxia therapy (dAIH), coupled with massed practice training, to improve~     upper-extremity function in individuals with chronic incomplete cervical spinal cord injury~     (SCI).~   "
10178|NCT03433586|"~     The PAVE study is a parallel trial of the effects of genetic variation in COMT in the~     presence or absence of Aspirin™ (81mg), placebo, and no treatment on platelet function.~     Healthy normal participants (N=90) between the ages of 18 and 40 years will be randomized to~     take daily placebo Aspirin™(81mg), placebo, and no treatment for 10+/- 3 days. Following each~     treatment, participants will have a 2-week washout period before taking the other treatments~     for an additional 10+/- 3 days. Blood samples will be taken at baseline and after each~     treatment for evaluation of platelet adhesion molecule expression and aggregation. Samples~     will also be evaluated for differential gene expression and metabolomic profiles.~   "
10179|NCT03433573|"~     Accuracy evaluation of the Abbott Sensor Based Glucose Monitoring System when used by~     children with diabetes.~   "
10180|NCT03433560|"~     The purpose of this observational study is to evaluate real-world safety and efficacy of~     pegfilgrastim (Neulasta) administered as secondary prophylaxis in Korean female patients with~     breast cancer receiving chemotherapy regimens recently covered under national health~     insurance. This is a prospective, observational, open-label trial with a target enrollment of~     1400 subjects.~      Primary endpoint The primary aim of this study is to determine the incidence of febrile~     neutropenia.~      Secondary endpoint Major secondary endpoint include a) Incidence of bone pain, b) All adverse~     events, c) Percentage of patients with RDI (relative dose intensity) ≥ 85%~   "
10181|NCT03433547|"~     Full-thickness macular Hole associated with macular detachment is a one of the maculopathies~     of high myopia. There is controversy in the primary treatment for this situation. This study~     will compare the effects of macular buckling versus vitrectomy in a cohort of highly myopic~     eyes with this situation.~   "
10182|NCT03433534|"~     To assess the relationship between progression free survival of patients treated with~     nivolumab for metastatic non small cell lung carcinoma or a metastatic renal cell carcinoma~     and nivolumab blood concentration.~      Collection of standard data prospectively.~   "
10183|NCT03433521|"~     Published data regarding the temporal pattern of AML are scarce and old. The greater~     knowledge of these neoplasias has made that their classification has been remarkable~     modified. Therefore, we consider relevant to carry out the present study as it would allow us~     to analyze the potential existence of a spatio-temporal pattern in the incidence of AML in~     Spain.~   "
10184|NCT03433508|"~     Consecutive cirrhotics who present to emergency department of ILBS with documented or~     suspected sepsis induced hypotension with Hb <8 gm/dl will be randomly assigned to~     restrictive (Target Hb 7-8 gm/dl) to liberal (Target Hb 10-11 gm/dl) group in a 1:1~     proportion At admission, all patients will undergo physical examination and baseline~     investigations to identify site of sepsis. Enrolled patients will be given PRBC-transfusion~     (Not more than two units of PRBC/day) when they reach their assigned trigger value (Hb 7-8~     g/dl or 10-11 g/dl ) during the entire ICU stay. All other interventions will be at the~     discretion of clinicians.~   "
10185|NCT03433495|"~     This study was conducted in three phases:~      The first phase involved creation of a Spanish adaptation of the Melodic Intonation therapy;~     the second phase consisted of a pilot non-randomized intervention study to analyse its~     feasibility for use with 4 Spanish patients with poststroke nonfluent aphasia; the third~     phase consisted of a pilot randomised, crossover, intervention pilot trial in a different set~     of patients with poststroke nonfluent aphasia (N=20)~   "
10186|NCT03433482|"~     MenACWY (Menveo) is a GSK vaccine intended for protection against disease caused by~     meningococcal bacteria groups A, C, W and Y in infants, children and adults, licensed in more~     than 60 countries.~      The purpose of this study is to compare the immunogenicity of the currently licensed MenACWY~     vaccine with the investigational MenACWY liquid vaccine aged for different lengths of time by~     storage at 2-8ºC.~   "
10187|NCT03433469|"~     This phase II trial studies how well osimertinib works in treating participants with stage~     I-IIIA Epithelial Growth Factor Receptor (EGFR) -mutant non-small cell lung cancer before~     surgery. Osimertinib may stop the growth of tumor cells by blocking mutant EGFR signaling in~     cancer cells.~   "
10188|NCT03433456|"~     The purpose of this study is to evaluate whether an intervention targeting healthy habit~     development reduces the risk and prevalence of obesity in low-income mothers and children.~     The study intends to evaluate whether the intervention, delivered in the context of home~     visitation services for low-income families, reduces weight gain and risk factors associated~     with parent and childhood obesity compared to those receiving standard home visitation~     services.~   "
10189|NCT03433443|"~     The aim of the current study is to examine the effect of a case manager-assisting~     rehabilitation program compared to usual physical rehabilitation for patients undergoing a~     lumbar spinal fusion on functional disability, pain, and return to work. Furthermore, to~     explore if the case manager-assisted rehabilitation program is cost-effective in a societal~     perspective compared to usual rehabilitation.~      Participants: 82 patients undergoing a lumbar spinal fusion due to disc degeneration or~     spondylolisthesis. Participants are adults of both gender.~      Patients are included from Aarhus University Hospital, Denmark, and Region Hospital of~     Silkeborg, Denmark. Participants will be block randomised at each centre. The participants~     were randomized 1:1 to case manager-assisted rehabilitation (intervention group) or usual~     physical rehabilitation (control group). Both groups received usual physical rehabilitation.~     The patients in the intervention group meet pre-operatively with a case manager in order to~     set a plan for their return to daily activities and work. The intervention also included~     post-surgical meetings, phone meetings, work place visits, or voluntary roundtable meetings.~   "
10190|NCT03433430|"~     An exploratory pilot study to evaluate the safety, efficacy and ergonomics of Cutera~     truSculpt device~   "
10191|NCT03433417|"~     Clinical Study to Evaluate the Performance the truSculpt Radiofrequency Device for Lipolysis~     of Abdominal Fat~   "
10192|NCT03433404|"~     Back pain is one of the most common complaints in pregnancy. It is caused by the growing~     pregnant abdomen which then strains the lower back and pelvis. Often Obstetricians recommend~     rest, Tylenol, pelvic support belts, or exercise. Typically, these do not provide the patient~     much relief. A physical therapy treatment known as soft tissue mobilization (tSTM) has been~     shown to be helpful in treating various types of pain. This study will explore whether tSTM~     can improve back pain in pregnancy.~   "
10193|NCT03433391|"~     This is a prospective, multi-center, randomized, controlled, patient and evaluator-blinded~     clinical study to assess the safety and effectiveness for the reduction of pain and symptoms~     following lumbar surgery.~   "
10194|NCT03433378|"~     Bioequivalence study comparing Tretinoin Cream, 0.05% to RETIN-A®.~   "
10195|NCT03433365|"~     This is an italian multicenter study to determine whether maintenance treatment with~     Lenalidomide-based regimen significantly increases the rate of molecular remission in~     patients achieving at least a VGPR after therapy with new drugs combination. No changing in~     the planned therapy will be made according to MRD results. A total of 70 patients with newly~     diagnosed MM who are 18 years of age or older and who meet all of the eligibility criteria~     may be enrolled in this study.~      Potential study subjects will sign an informed consent prior undergoing any study related~     procedure. Patients enrolled in this study will receive Lenalidomide-based regimen as~     maintenance therapy according to their previous decided therapeutic schedule. All consecutive~     patients treated with Lenalidomide-based regimen as maintenance therapy and with inclusion~     criteria will be asked to participate to this study.~      No additional drugs will be administrated for this study whose aim is to monitor the MRD on~     bone marrow aspirate and peripheral blood of patients during maintenance therapy with~     Lenalidomide-based regimen.~   "
10196|NCT03433352|"~     Graves' disease is an organ-specific autoimmune disease in which both genetic predisposition~     and environmental factors serve as disease triggers. Many studies have indicated that~     alterations in the gut microbiota are important environmental factors in the development of~     inflammatory and autoimmune diseases. Investigators systematically performed a comparative~     analysis of the gut microbiota in GD patients and healthy controls and analyse the~     relationship between intestinal microbiota and GD drug therapy.~   "
10197|NCT03433339|"~     This pilot clinical trial will evaluate the efficacy and safety of transcutaneous direct~     current stimulation (tsDCS) in major depressive disorder.~   "
10198|NCT03433326|"~     CryoKid is a no-profit, multi-center, single-arm, open-label, pilot study. The study aims to~     evaluate the tolerability of MK-8742 (Elbasvir) / MK-5172 (Grazoprevir) administrated for 12~     weeks without Ribavirin in patients with HCV chronic hepatitis (G1b and G4) and~     cryoglobulinemic nephropathy.~   "
10199|NCT03433313|"~     The purpose of this research study is to compare the effectiveness and safety of EG12014~     against trastuzumab in women with early breast cancer.~   "
10200|NCT03433300|"~     High-quality, empirical evidence to guide prosthetic rehabilitation following amputation~     ensures that Service members, Veterans, and civilians who experience limb loss have the~     potential to receive the highest quality care, regain mobility, return to gainful employment,~     and reintegrate into their communities. However, evidence to inform prosthetic care during~     the crucial post-amputation period is extremely limited. The proposed research will address~     this gap in knowledge by evaluating functional and patient-centered health outcomes~     associated with use of two distinct prosthetic knee technologies in early rehabilitation~     following transfemoral amputation. This novel, comparative effectiveness research aligns with~     the Prosthetic Outcomes Research Award (PORA) focus area of understanding the management of~     patient rehabilitation strategies throughout the rehabilitation process following~     neuromuscular injury.~      The long-term goals of this project are to optimize early rehabilitation processes and~     associated outcomes for Service members, Veterans, and civilians with lower limb amputation.~     The purpose of this study is to evaluate the potential for different prosthetic knee~     technologies to promote function, health, and quality of life following amputation. A pilot~     randomized controlled trial will be conducted to compare falls, step activity, balance~     confidence, mobility, health-related quality of life, and community integration of people~     with recent transfemoral amputation in two prosthetic knee conditions: a microprocessor knee~     (MPK) with control of stance phase and a non-microprocessor knee (NMPK) that is appropriate~     for people in early rehabilitation.~   "
10201|NCT03433287|"~     Chronic recurrent multifocal osteomyelitis (CRMO) is an immune-mediated chronic inflammatory~     self- limiting disease with non-suppurative inflammation involving one or multiple bone foci.~     A bacterial etiology has not yet been proven, but the investigators hypothesize that CRMO is~     caused by chronic infection. Using existing knowledge of chronic infections combined with~     sensitive molecular techniques, the hope is to elucidate the cause of CRMO by proving or~     disproving bacteria as the underlying etiology.~      In addition, a novel method, 18F-NaF-PET/MRI, will be investigated as to which it can improve~     diagnosis of CRMO. The investigators hypothesize that 18F-NaF-PET/MRI will have higher~     diagnostic accuracy than 99m-diphosphonate planar bone scintigraphy and SPECT/CT.~   "
10204|NCT03433235|"~     The investigators hypothesize that earlier initiation of edoxaban in AF-related stroke~     patients may significantly reduce the early recurrence of ischemic stroke, compared with~     conventional strategy of anticoagulation following 1-3-6-12 rule. To expedite the~     verification of the hypothesis, the investigators are planning to use diffusion weighted~     imaging (DWI), which has been reported to be a surrogate to predict both short-term and~     long-term prognosis after stroke, to detect the recurrent ischemic events. Because data on~     the early anticoagulation in patients with AF-related stroke are limited, the investigators~     decided to perform a pilot study before establishing an appropriate clinical trial protocol.~     This study will help estimate the efficacy and safety of early administration of edoxaban,~     and determine the sample size of a following clinical trial. To ensure the safety in this~     pilot exploration, the investigators will not include patients with severe ischemic strokes,~     who are often prone to experience hemorrhagic transformation in the acute post-stroke period.~   "
10205|NCT03433222|"~     The goal of this study is to establish the safety of high fluence LED-RL at fluence of 480~     J/cm2 and 640 J/cm2 in healthy non-Hispanic, Caucasian subjects. The hypothesis is that high~     fluence LED-RL phototherapy is safe in non-Hispanic, Caucasians.~   "
10206|NCT03433209|"~     The effect of two different bipolar instruments were compared in terms of operative time,~     total operative time, intra-operative blood loss and intra-operative and postoperative~     complications. Devices included the LigaSure™ Maryland Jaw 5 mm laparoscopic instrument~     (LigaSure; LF 1737, Covidien, Mansfield, MA, USA) and ENSEAL™ G2 Articulating Straight 5mm~     Tissue Sealer (ENSEAL; NSLG2S35A, Ethicon Endo-surgery, US, LLC).~   "
10207|NCT03433196|"~     To determine the efficacy of HS-25 (20mg) in reducing low density lipoprotein-cholesterol~     (LDL-C) levels after a 12-week period of treatment in combination with Atorvastatin in~     subjects with hypercholesterolemia and coronary heart diseases; To determine the safety of~     HS-25 (20mg) combination with Atorvastatin in subjects with hypercholesterolemia and coronary~     heart diseases~   "
10208|NCT03433183|"~     To determine the clinical benefit rate of selumetinib in combination with vistusertib in~     patients with unresectable or metastatic neurofibromatosis type 1 (NF1) associated or~     sporadic MPNST.~   "
10209|NCT03433170|"~     Randomized controlled trial comparing reconstruction of anterior cruciate ligament (ACL) with~     autologous quadrupled semitendinosus graft or with both semitendinosus and gracilis. It is~     intended to specially evaluate if by using only the semitendinosus (ST) tendon, the strength~     of the limb for hamstrings is affected different compared to using both gracilis and ST.~   "
10210|NCT03433157|"~     The purpose of this study is to evaluate and compare the clinical performance of Stainless~     Stain Crowns Placed Using the Hall Technique and Traditional Technique~   "
10211|NCT03433144|"~     This study seeks to answer the question: Does a single pre-operative dose of tranexamic acid~     have a statistically significant reduction in blood loss during orthognathic surgery?~      If it does, this drug may begin to be used routinely during orthognathic surgery to reduce~     blood loss in our patients.~   "
10212|NCT03433131|"~     This EAP will be open to provide access to treatment with pitolisant while a U.S. New Drug~     Application (NDA) is being prepared and submitted for review for marketing approval. This~     program will be open to adult patients in the U.S. with Excessive Daytime Sleepiness (EDS)~     associated with narcolepsy, with or without cataplexy. Pitolisant will be made available~     through treating physicians participating in the program.~   "
10213|NCT03433118|"~     Feasibility randomized controlled trial of standard care v standard care + acupuncture~     administered by specially-trained therapy radiographers in patients undergoing radiotherapy.~     It is a feasibility study to investigate all aspects of a future definitive randomized~     controlled trial, including statistical power calculation, hence there is no primary outcome~     or time point.~      Mixed methods: literature review, model validity, training and mentoring of radiographers,~     processes, resources, interventions, procedures, patient clinical outcomes, patient and~     stakeholder qualitative outcomes~   "
10214|NCT03433105|"~     1.Research hypothesis: during weaning patient from prolonged mechanical ventilation, if the~     work load caused by weaning was below the patient's AT, oxygen uptake will be constant.~     Otherwise, if the work load was above the patient's AT, the oxygen uptake will increase.~        1. Patient: who have tracheostomy tubes and with prolonged mechanical ventilation~        2. Measurement: oxygen uptake(V̇O2) and respiratory mechanics during the spontaneous~          breathing trials~        3. Outcome: Correlation between the oxygen uptake(V̇O2) and the weaning outcome~      2.Specific aims:~        1. to investigate the prognostic value of oxygen uptake in weaning patients from prolonged~          mechanical ventilation~        2. Subgroup analysis may suggest which weaning protocol potentially benefit the most for~          each population group (cardiovascular disease, chronic pulmonary disease, neuromuscular~          disease, cerebrovascular disease)~   "
10215|NCT03433092|"~     Previous studies have suggested that serum carotenoids may be associated with risk of~     gastrointestinal tract cancer (GIT cancer), but the results were inconsistent. Thus, the~     investigators conducted a meta-analysis to evaluate the associations between serum~     carotenoids and risk of GIT cancer.~   "
10216|NCT03433079|"~     Acute kidney injury (AKI) represents a serious complication following severe injury~     associated with adverse outcome. Main goals of the presented study were to define the~     incidence of AKI and to evaluate the validity of AKI biomarker neutrophil~     gelatinase-associated lipocalin (NGAL) in AKI prediction in severely injured patients.~     Secondary goals were to determine the time-dependent role of injury-related tissue hypoxia,~     systemic inflammatory response, and rhabdomyolysis in the pathophysiology of AKI.~   "
10217|NCT03433066|"~     The aim of this study is to clinically and radiographically evaluate the efficacy of advanced~     platelet-rich fibrin (A-PRF) when used with biphasic alloplast in the management of intrabony~     defects in patients with moderate to severe chronic periodontitis.~   "
10218|NCT03433053|"~     The goals of this study are to:~        1. Develop a HIV test message tailored for African American women. A generic non-tailored~          message will be developed as well for comparison. A third group will be included that~          will not be exposed to any message at all.~        2. Test the effectiveness of both messages on reported future intentions to get tested for~          HIV and HIV test behavior at 3 month follow up.~   "
10375|NCT03430999|"~     Randomized, double-bline, placebo-controlled, single dose study comparing the~     pharmacokinetics (PK) and safety of PP095-01 in Japanese and non-Asian (eg, Caucasian)~     subjects.~   "
10221|NCT03433014|"~     The study design is a prospective randomized, double-blind, controlled trial of patients who~     are due to have elective laparoscopic colorectal surgery in Ramathibodhi Hospital. The~     primary objective is to measure pain scores (Visual Analog Scale) in the postoperative~     period. The secondary objective is to compare the VAS scores between the two types of~     technique used for specimen retrieval incision.After approval by the ethics committee,~     patients scheduled for elective laparoscopic colorectal surgery under general anesthesia who~     are eligible for inclusion criteria were recruited for this study after informed consent by~     surgical residents or surgical staff at the Outpatient Department (OPD). Patients who meet~     the exclusion criteria will be excluded.~   "
10222|NCT03433001|"~     The purpose of this study is to investigate the real world effectiveness and safety of~     ixazomib in combination with lenalidomide and dexamethasone (IRd) in patients with relapsed~     and/or refractory multiple myeloma (RRMM), under conditions of standard medical care. In~     addition, an exploratory study of biomarkers will be conducted.~   "
10223|NCT03432988|"~     Aim: To test the hypothesis that fluid adherence in patients on hemodialysis can be improved~     through nurses´ solution-focused communication with patients on issues of adherence.~      Design: Single-group quasi-experimental study. Method: A one-month baseline of inter-dialytic~     weight gain was taken for a group of 36 adult patients in a hospital hemodialysis unit. Then,~     the nurses of the unit received an 5-hour training in solution-focused communication on~     issues of fluid adherence and applied it with the patients of the sample. Inter-dialytic~     weight gains (IDWG) were measured during another month. Six months after the training, IDWG~     was again measured during one month.~   "
10224|NCT03432975|"~     The study will be conducted at the Department of Periodontology, Cliniques universitaires~     Saint Luc. Patients diagnosed with Generalized Chronic Periodontitis (GChP) based on the~     current classification of the American Academy of Periodontology will be included. Detailed~     medical, periodontal and dental history will be obtained. Those who will fulfill the~     inclusion/exclusion criteria will be invited to participate in the study.~   "
10225|NCT03432962|"~     Measuring diet is difficult. This is the first time that brand level foods and nutrient~     values have been compared with generic food codes to explore the difference this might make~     to estimated nutrient intakes.~   "
10226|NCT03432949|"~     More than 90% of patients with metastatic castration-resistant prostate cancer (mCRPC) no~     longer responding to androgen deprivation hormonal therapy have evidence of bone metastases.~     This is a major cause of death, disability, and decreased quality of life.~      Radium-223 is radiopharmaceutical meaning that the drug is a radioactive compound used for~     therapeutic purposes. It is given intravenously (through a vein) every 4 weeks for 6 cycles.~     Research has demonstrated safety and efficacy in mCRPC patients resulting in radium-223~     becoming a standard of care option for such patients in addition to chemotherapy and new oral~     hormonal drugs enzalutamide or abiraterone.~      Prior research studies using radium-223 have shown improved survival in about 30% of~     patients. The same studies in combination with data collected from clinical use have also~     shown that between 20 and 50% of men do not complete the full 6 cycle course of treatment due~     to side effects or a rise in prostate specific antigen (PSA) requiring the stoppage of~     radium-223 therapy to start one of the other drug therapies.~      The purpose of this study is to determine whether an oral drug called dexamethasone (a~     corticosteroid) given together with radium-223 may control PSA levels and reduce side effects~     during radium-223 treatment. Corticosteroids are anti-inflammatory medicines prescribed for a~     broad range of conditions and are widely used in conjunction with chemotherapy treatments for~     cancer. Prior research studies have shown that dexamethasone reduces PSA levels by lowering~     the production of androgens (i.e. male hormones) and improves overall tolerance for~     cancer-fighting drugs and therapies.~      Up to 24 men being treated with radium-223 at University Health Network will be enrolled into~     this study. If the study is positive, it might offer an improved quality of life and extended~     survival.~   "
10227|NCT03432936|"~     This research study is being done to look at new MRI imaging guidance software, Philips~     Interventional iSuite software, to see if using will improve the physician's ability to~     quickly place and guide needle tip position for biopsies and ablations.~   "
10228|NCT03432923|"~     A multi-center, double-blind, randomized, parallel-group, placebo-controlled study to~     determine the efficacy and safety of a benzocaine lozenge for symptomatic treatment of sore~     throat caused by acute upper respiratory tract infection in adults.~   "
10229|NCT03432910|"~     This study analyzes the application of the Forced Breath Technique (FBT) to classify apneas~     during CPAP therapy with a prismaLAB (device name) therapy device.~      In this study the BiLevel ST (Spontaneous / Timed) therapy mode of the prismaLAB device is~     reduced to a CPAP pressure profile with exhalation relief by minimization of the pressure gap~     between exhalation and inhalation pressure.~      The FBT based apnea classification of the devices firmware is matched with the by hand~     scoring of the polysomnographic data that is usually used to evaluate the quality of patients~     sleep.~   "
10230|NCT03432897|"~     This study will evaluate approximately 3 months of treatment with the drug olaparib in~     patients with prostate cancer. A capsule formulation of olaparib (tradename Lynparza™) is~     approved by the United States Food and Drug Administration (FDA) for the treatment of women~     with advanced BRCA-mutated ovarian cancer. Olaparib is an investigational drug in prostate~     cancer. A tablet formulation of olaparib is being tested in this study. It is a new~     formulation which is more convenient for patients than the approved capsule formulation~     because fewer tablets of olaparib need to be taken daily than with capsules.~      The purpose of the study is to evaluate whether olaparib can reduce prostate cancer with~     defects in DNA repair genes when olaparib is given for approximately 3 months before surgery.~   "
10231|NCT03432884|"~     A Two-Part Phase 1 Study to Investigate A) Safety and Tolerability of Supratherapeutic dose~     of Zanubrutinib (BGB-3111) and B) Effect of Zanubrutinib on Cardiac Repolarization in Healthy~     Subjects~   "
10253|NCT03432598|"~     This is a Phase II, open-label, 4-cohort study of the monoclonal antibody BGB A317 in~     combination with standard platinum-based chemotherapy in subjects with advanced NSCLC or~     SCLC. The 4 cohorts will be enrolled concurrently including non-squamous NSCLC Cohort,~     squamous NSCLC Cohort A, squamous NSCLC Cohort B and SCLC Cohort. Subjects with a mixed~     adenocarcinoma and squamous cell NSCLC will be allocated to one of the NSCLC cohorts based on~     the predominant histopathological profile. (e.g., subjects with adenocarcinoma component~     accounting for > 50% will be allocated to non-squamous NSCLC cohort.) Subjects with squamous~     NSCLC will be sequentially enrolled into either of the 2 squamous NSCLC cohorts by the trial~     stage i.e. the sequence of the enrollment for the squamous NSCLC cohorts will be as Cohort A~     safety run-in Stage, followed by Cohort B safety run-in Stage, Cohort A dose-expansion stage~     and Cohort B dose-expansion Stage.~   "
10254|NCT03432585|"~     This study will assess and evaluate conference attendance feasibility and will gather~     feedback about preferences and barriers to attendance at the American Society for Nutrition~     annual conference.~   "
10232|NCT03432871|"~     Mitochondria are important parts of the cell that are responsible for producing energy. The~     amount of energy they produce depends on how much energy the body needs to function and this~     energy production can be severely impaired in people with mitochondrial disease. Symptoms of~     mitochondrial disease vary widely but usually involve the brain, nerves and muscles, as these~     are tissues that need a lot of energy. Mitochondrial disorders affect 1 in 5000 of the UK~     population and there is currently no cure.~      Some scientists think that increasing the number of mitochondria in the body (mitochondrial~     biogenesis) might be an effective treatment for the symptoms of mitochondrial disease.~     Studies carried out in mice have shown that a type of B-vitamin called Nicotinamide Riboside~     (NR) is able to increase the number of mitochondria, leading to increased energy and a~     reduction in the symptoms of mitochondrial disease.~      The aim of this study is to investigate if the same B vitamin, Nicotinamide Riboside, can~     increase energy production and reduce symptoms in humans with mitochondrial disease.~      The study will consist of two parts:~      Part 1: Participants will be given a single oral dose of Nicotinamide Riboside and the levels~     of NR in their bloodstream will be measured at regular intervals. This will involve a single~     overnight stay and simple blood tests.~      Part 2: This requires 6 separate visits from each participant. Each participant will undergo~     a series of standard tests including a muscle biopsy and an MRI scan, then they will take a~     course of Nicotinamide Riboside (twice daily for 4 weeks). After 4 weeks of treatment, the~     participants will undergo the same tests again to see if there have been any changes in~     response to the treatment.~   "
10233|NCT03432858|"~     This is a clinical trial to determine how effective antibiotics administered prior to~     endoscopic carpal tunnel release surgery are in preventing surgical site infections.~   "
10234|NCT03432845|"~     Patients who require bariatric surgery frequently bring a panoply of pre-existing~     comorbidities to the operating theatre. With body mass indices routinely in the 50s and 60s,~     patients who have bariatric surgery frequently have postoperative and post-discharge nausea~     and vomiting (PONV and PDNV)~   "
10235|NCT03432832|"~     This project will address impaired emotion regulation in adolescents with ASD (autism~     spectrum disorder). There are no evidence-based interventions to improve emotion regulation~     (ER) in this population, yet poor emotion regulation often leads to maladaptive behavior and~     substantially impedes capacity to learn and function across all life settings, and reduce~     their quality of life and that of their families. The primary objective of this study is to~     formally evaluate efficacy of EASE via a sufficiently powered, two-site randomized-controlled~     trial (RCT).~   "
10236|NCT03432819|"~     R34-funded study to pilot test an intervention to improve coping with discrimination and~     adherence among Latino MSM living with HIV. The proposed research aims to modify and refine~     Siempre Seguiré, a culturally congruent cognitive behavior therapy group intervention for~     HIV-positive LMSM, to include strategies for ART adherence and retention in HIV care; and to~     conduct a small randomized pilot of Siempre Seguiré to examine feasibility and acceptability,~     as well as to explore preliminary effects on coping responses to discrimination and~     antiretroviral treatment adherence among LMSM living with HIV.~   "
10237|NCT03432806|"~     The purpose of this study is to explore novel ways of diagnosing colon cancer and predicting~     its propensity to spread to other organs such as the liver.~   "
10238|NCT03432793|"~     This study is designed to assess the effect of fluvoxamine, itraconazole and smoking on the~     PK disposition of multiple doses TD-9855 in healthy male subjects. The study will also assess~     the relationship between caffeine PK and TD-9855 PK disposition in healthy male smokers and~     non-smokers.~   "
10239|NCT03432780|"~     A prospective, multicenter, parallel-group, open-label, randomized, phase II Clinical Study~     of Radiation Therapy, Hormone Therapy and Docetaxel Versus Radiation Therapy and Hormone~     Therapy in Patients with High-Risk Localized Prostate Cancer (Stage III and IV) whose primary~     objective is determine the percentage of patients free of biochemical recurrence within 5~     years of receiving a combination of radiation therapy with docetaxel associated with hormone~     therapy or the standard of care of radiation therapy and hormone therapy in patients with~     stage III and IV localized prostate cancer with a poor prognosis.~   "
10240|NCT03432767|"~     Postpartum hemorrhage (PPH) is a leading cause of maternal mortality and morbidity, and is~     most commonly caused by poor uterine tone after delivery of the baby and placenta. Currently,~     a lack of early identification of PPH also results in delayed treatment, with an increase in~     morbidity. The investigators propose that 2 non-invasive methods may provide monitoring for~     early and accurate detection of PPH. These methods include shock index (SI) and continuous~     hemoglobin (Hb) monitoring. SI is defined as heart rate divided by systolic blood pressure,~     and can be used as a marker to predict the severity of hypovolemic shock. Continuous Hb~     monitoring can now be done using a non-invasive probe that is placed on the patient's finger.~     It provides real-time Hb values, rather than having to draw blood and wait for a lab test.~      The investigators hypothesize that SI will have a stronger association with postpartum blood~     loss than Hb variation.~   "
10241|NCT03432754|"~     The investigators conducted a mindfulness training intervention in older adults aimed at~     examining the effects of brief mindfulness training on mind wandering as well as the~     cognitive and affective functioning of older adults. Individuals completed pre- and~     post-assessments of mind wandering and cognitive functioning. Additionally, all participants~     completed neuropsychological measures and self-report questionnaires.~   "
10242|NCT03432741|"~     This pilot phase I trial studies the side effects of direct tumor microinjection and~     fludeoxyglucose F-18 positron emission tomography (FDG-PET) in testing drug sensitivity in~     patients with non-Hodgkin lymphoma, Hodgkin lymphoma, or stage IV breast cancer that has~     returned after a period of improvement or does not respond to treatment. Injecting tiny~     amounts of anti-cancer drugs directly into tumors on the skin or in lymph nodes and~     diagnostic procedures, such as FDG-PET, may help to show which drugs work better in treating~     patients with non-Hodgkin lymphoma, Hodgkin lymphoma, or breast cancer.~   "
10243|NCT03432728|"~     Salivary samples were obtained from 20 children in their fifth year of life diagnosed S-ECC~     and 20 age and sex matched controls. Complete dental rehabilitation under general anesthesia~     was performed for the 20 children with S-ECC, and follow up salivary samples were obtained~     one week and three months post operatively. The TAC was measured using a commercially~     available Oxygen Radical Absorbance Antioxidant Assay measurement kit (Zen-Bio ORAC™, AMS~     Biotechnology, Abington UK).~   "
10244|NCT03432715|"~     The Wellness Champions for Change (WCC) study aims to reduce pediatric obesity among students~     who attend schools in Maryland by training teacher and student-led wellness teams to increase~     opportunities for physical activity and healthy eating at school.~      The study uses a cluster randomized design to allocate 6 schools (3 elementary, 3 middle) in~     5 school systems to one of 3 arms: A (teacher and student training), B (teacher training~     only), and C) (delayed teacher training/control). Approximately 36 3rd/6th graders and~     their caregivers (evaluation cohort), 15 4th/7th graders (student leaders), and 20~     teachers from each school will be recruited in the spring before the intervention. All~     schools will identify a teacher Wellness Champion who will coordinate intervention~     activities. In A and B schools, wellness champions will attend a training to learn how to~     build a wellness team and create more opportunities for students to make healthy choices. In~     A schools, student leaders (Student Wellness Champions) will meet weekly during lunch~     with a health educator to receive training as peer leaders and help the Wellness Champion~     with wellness initiatives. Student leaders in B and C schools will receive a monthly~     general Adolescent Health Curriculum. To assess the impact of the teacher and student-led~     interventions, the evaluation cohort will be followed for 2.5 years, with measures including:~     anthropometry (height/weight), 7-day accelerometry (physical activity), and validated~     questionnaires to assess healthy eating. Student leaders will be followed for 1.5 years to~     assess the impact of their participation, with measures including: anthropometry, 7-day~     accelerometry, validated questionnaires to assess healthy eating, and validated~     questionnaires and focus groups to assess leadership/advocacy skills. Teachers will complete~     validated questionnaires to investigate their perceptions of the school environment,~     classroom practices, and role modeling skills. Prior to data collection and analysis,~     participants will be assigned an identification number, and all documents linking participant~     information to identification numbers will be locked/ password-protected.~   "
10245|NCT03432702|"~     To evaluate dimensional bone alterations following horizontal ridge augmentation using guided~     bone regeneration (GBR) with or without autogenous block graft (ABG) for the rehabilitation~     of atrophic jaws with dental implants.~   "
10246|NCT03432689|"~     Transcranial magnetic stimulation (rTMS) is an investigational and therapeutic modality that~     impacts the connection strength between neurons by delivering patterned energy. In response~     to this patterned energy neurons fire and adapt by changing their connection strengths. This~     change in connection strengths is believed to be the underlying mechanism whereby this~     intervention has therapeutic benefit for this intervention in conditions such as depression.~     The purpose of this study is to test a means of enhancing the effect of rTMS using a~     medication (cycloserine) that has been shown to augment and stabilize activity dependent~     neuronal changes. The investigators wish to use the motor system, where the associated muscle~     response to brain stimulation can be measured, to probe activity dependent changes in~     connection strength between neurons.~   "
10247|NCT03432676|"~     The goal of this clinical research study is to learn if epacadostat in combination with~     pembrolizumab can help to control previously treated pancreatic ductal adenocarcinoma in~     patients who have a specific type of genetic change. This type of genetic change may mean you~     are more likely to respond to the study drugs.~      The safety of this combination will also be studied.~      This is an investigational study. Epacadostat is not FDA approved or commercially available.~     It is currently being used for research purposes only. Pembrolizumab is FDA approved and~     commercially available for the treatment of many types of cancer. It is investigational to~     use pembrolizumab to treat pancreatic ductal adenocarcinoma.~      The combination of these drugs is considered investigational. The study doctor can explain~     how the study drugs are designed to work.~      Up to 21 participants will be enrolled in this study. All will take part at MD Anderson.~   "
10248|NCT03432663|"~     Sixty consecutive emergency patients with newly diagnosed Atrial Fibrillation were randomized~     into two groups. The first received intravenous amiodarone infusions continuously for 24~     hours; the second received Amiodarone until sinus rhythms was reached or for up to 72 hours.~      The efficacy and safety of administering intravenous infusions of amiodarone for up to 72~     hours were investigated and compared to the efficacy and safety of administering a standard~     24 hours infusion of amiodarone. Specifically, the use of up to 72 hours infusions was~     considered as a new strategy to improve rates of conversion to sinus rhythm without altering~     the safety profile of the drug.~   "
10249|NCT03432650|"~     Hip arthroscopy is performed frequently and the postoperative course often involves moderate~     to severe pain. There remains no definitive perioperative pain regimen that has been proven~     to be effective and safe for this ambulatory procedure. Some institutions perform peripheral~     nerve blocks either preoperatively or postoperatively as a rescue block. All of these PNBs~     lead to quadriceps weakness which may impede earlier mobilization and physical therapy. While~     some case reports exist, there have not been any studies evaluating the QLB for hip~     arthroscopy patients. As previously mentioned, the technique is easy to perform,~     well-tolerated by patients, and avoids side effects such as hypotension, urinary retention,~     or the quadriceps weakness associated with lumbar plexus blockade.~   "
10250|NCT03432637|"~     With the development of video-assisted thoracoscopic surgery (VATS) techniques and technology~     for anesthesia control, non-intubated anesthesia with spontaneous ventilation has been widely~     applied in VATS. A prospective, multicentre, randomized controlled clinical study was applied~     in this study to assess the feasibility and safety of thoracoscopic lobectomy under~     spontaneous ventilation versus intubated single lung mechanical ventilation.~   "
10251|NCT03432624|"~     Pancreatic cancer represents the most lethal of the common malignancies, with a 5-year~     survival rate of less than 5%. For patients who, when are diagnosed of pancreatic cancer, are~     eligible for potentially curative resection, the mortality and morbidity rates after surgery~     can improve significantly, but who accounts for no more than 20% of all pancreatic patients.~     It is therefore an effective way to improve the treatment efficacy for pancreatic cancer by~     discovering novel detection methods for pancreatic cancer, especially at early stages.~     MicroRNAs have been proved in recent years as functional disease markers, and circulating~     microRNA-25 is reported of high pancreatic cancer specificity and can be used as a novel~     marker for pancreatic cancer. A detection kit MicroRNA (microRNA-25) Qualitative Detection~     Kit (Fluorescent PCR Method) is produced and proven to be effective in assisting the~     diagnosis of pancreatic cancer through clinical trials held independently in three~     state-level hospitals in China. To further validate the efficacy of the kit, the researchers~     in this study intend to compare the sensibility and specificity of microRNA-25 level~     detection and other diagnosis methods, including detection of conventional tumor markers~     (CA19-9, CA125, CA50, CEA) and imaging (CT, MRI, PET/CT), both in separation and combined, in~     the diagnosis of pancreatic cancer.~   "
10252|NCT03432611|"~     With a randomized, pragmatic study the effectiveness of a smartphone app for menstrual pain~     in 18-34-year-old women with primary dysmenorrhea will be investigated.~   "
10376|NCT03430986|"~     The purpose of this study is to determine whether VOLUMA with Lidocaine is safe and effective~     for the improvement of volume and aesthetic appearance of the nose in the Chinese population.~   "
10255|NCT03432572|"~     Recently, Indigo Carmine and Methylene Blue have been the standard agents to visualize~     ureteral jets during intraoperative cystoscopy. However, due to a national shortage of Indigo~     Carmine and Methylene Blue, there is a need to discover alternative IV and oral agents that~     are readily available and well tolerated when used for visualizing ureteral jets at the time~     of intraoperative cystoscopy. The aim of this study is to look at oral agents that have been~     studied such as pyridium (Phenazopyridine Hydrochloride) and riboflavin and compare them in a~     three-arm double-blinded randomized controlled pilot study using riboflavin, pyridium, and a~     placebo. The aim of the study is to provide evidence that both pyridium and riboflavin are~     effective and safe for staining urine to facilitate visualization of jets in evaluating~     ureteral patency at the time of intraoperative cystoscopy.~   "
10256|NCT03432559|"~     Transesophageal echocardiography is commonly used during cardiac surgery. Complications of~     transesophageal echocardiography are rare (1,2%), but are often underestimated and can lead~     to unrecognized blood loss and site of infection.~      This study wants to assess the mucosa of pharynx, upper larynx, esophagus and stomach prior~     to and after echo probe insertion during cardiac surgery with endoscopy.~   "
10257|NCT03432546|"~     Approximately 20,000 patients are treated in intensive care units (ICU) in Finland annually.~     During ICU stay many diagnostic and other procedures as well as immobilization and underlying~     diseases may cause pain. Therefore the incidence of pain in ICU patients can be high. Acute~     pain may cause several detrimental effects including respiratory distress, tissue hypoxia,~     immunosuppression and anxiety. After discharge many survivors of critical care have lower~     health-related quality of life, symptoms of post-traumatic stress disorder or persistent~     pain.~      Only few studies with a focus on acute or persistent pain in ICU patients have been made,~     hence the incidence and risk factors for ICU-related pain is not very well known. Some of the~     identified risk factors for persisting pain may be increased age, sepsis or inadequate pain~     management during ICU stay. Opioids are most often used for analgesics in intensive care.~     Because they may have several adverse effects the use must be based on validated pain scales.~     Many factors such as sedation, relaxation or delirium of the patient complicates the~     management of the pain.~      This prospective observational study aims to determine the incidence and risk factors for~     acute and persistent pain in ICU patients as well as and the use of analgesics during~     intensive care.~   "
10258|NCT03432533|"~     To evaluate the noninferiority of a 6-month treatment with 210 mg romosozumab at 90 mg/mL~     administered subcutaneously (SC) once a month (QM) in postmenopausal women with osteoporosis~     either by healthcare provider (HCP) administration with prefilled syringe (PFS) or by subject~     self-administration with autoinjector/pen (AI/Pen)~   "
10259|NCT03432520|"~     This long-term follow-up study will continue to evaluate the long-term safety and efficacy of~     SPK-8011 in males with hemophilia A, who have received a single intravenous administration of~     SPK-8011 in any Spark-sponsored SPK-8011 lead-in study.~   "
10260|NCT03432507|"~     All patients scheduled for lumbar spine surgery due to discogenic low back pain and/or~     sciatica, will be screened by the principal investigator for presence of inclusion/exclusion~     criteria. Their baseline neurological function before surgery will be assessed and recorded~     for recruitment into one of the three study groups. MRI scans will be assessed for the~     calculation of disc protrusion size. Experimental sensory and pain assessments and~     questionnaires will be performed at list 24 hours before surgery. Blood sample for~     pro-inflammatory mediator will be obtained at the same time as the experimental sensory and~     pain tests. Pre-operative pain and MPQ will be assessed pre-operatively (back and leg pain~     separately), and again on day 30 after surgery. Blood tests for ESR, CRP will be drawn before~     surgery, during the surgery, and on 30 after surgery. During surgery, intervertebral disc~     material will be harvested and divided into 4 specimens for culture and inflammatory mediator~     analysis. Repeat neurological assessment will be performed 30 after surgery.~   "
10261|NCT03432494|"~     Background:~      TAVR is a common therapy for people with heart problems as a better option than surgery. It~     stands for transcatheter aortic valve replacement. It is usually done by inserting a catheter~     (thin tube) through a groin artery. But this isn t safe for everyone. Researchers developed a~     new technique called transcaval access. The catheter is placed in the artery deep in the body~     by crossing through the wall of a deep vein. The connection between that vein and the aorta~     is closed with a new metallic device they are testing. This is called a transcaval closure~     device (TCD).~      Objective:~      To test the safety and early feasibility of closure of transcaval aortic access sites using~     the TCD after TAVR.~      Eligibility:~      Adults ages 21 and older undergoing TAVR for whom the procedure cannot be performed safely by~     the standard artery approach~      Design:~      Participants will be assessed by heart experts including cardiologists and surgeons.~      Participants will have TAVR by the transcaval approach. A small catheter will be passed~     between the largest vein in the body and the nearby largest artery (aorta), inside the~     abdomen. Through this catheter, the TAVR will be implanted in the usual way.~      After, doctors will implant the TCD by catheter to close the hole made in the aorta.~      Participants will be X-rayed. A dye will be injected to view the TCD device.~      Participants will get standard TAVR care afterwards. They will have physical exams, blood~     tests, and scans.~      Participants will have a follow-up scan within 1 month and after 12 months.~      Participants will have follow-up visits and phone calls 6 and 12 months after the procedure.~   "
10262|NCT03432481|"~     This study is designed to observe clinical outcomes of patient-specific knee arthroplasty in~     patients with osteoarthritis of the medial condyle.~   "
10263|NCT03432468|"~     This study compared the improvements of blood pressure levels, left ventricular hypertrophy,~     left ventricular diastolic function, vascular function and cognitive function between~     postmenopausal hypertensive women and age-matched hypertensive male patients through the~     evaluation of the effects of fully blocked AT1 receptor by valsartan. Additionally, the~     differences of the above indexes between the patients who were fully blocked AT1 receptor by~     valsartan and the patients who were treated with a single dose of valsartan treatment were~     assessed, so as to provide theory basis for clinical treatment of postmenopausal hypertensive~     women.~   "
10264|NCT03432455|"~     This is a descriptive, retrospective, multi-center, cross-sectional and observational~     epidemiological study of incidence and prevalence of juvenile dermatomyositis in Alsace from~     2000 to 2015. Alsace is a French region with a low migratory flow~   "
10265|NCT03432442|"~     Design and Outcomes This research study is designed as open-label, sequential dose-escalating~     clinical trial. There will be two phases of enrollment.~      In the first phase, pediatric dengue patients with body weight greater than 30 kg will be~     recruited. The first six volunteers will be administered with 400 μg/kg every 24 hours for a~     total of three times. The last six volunteers will be administered with 600 μg/kg every 24~     hours for a total of three times.~      In the second phase, pediatric dengue patients with body weight between 15 to 30 kg will be~     recruited. Similar to the first phase, the first six and the last six volunteers will be~     administered with 400 μg/kg and 600 μg/kg every 24 hours for a total of three times,~     respectively.~      A total of 24 volunteers will be recruited from Faculty of Medicine Siriraj hospitals~   "
10266|NCT03432429|"~     REI-EXCISE is a multicentre, prospective, non-randomised feasibility study, aimed to evaluate~     the diagnostic accuracy of rapid ionisation mass spectroscopy using an iKnife device. The~     iKnife will collect vapour, a by-product of surgery, which will pass through the mass~     spectrometer machine for analysis in order to evaluate what is normal and what is~     cancerous breast tissue.~   "
10267|NCT03432416|"~     This will be a multi-site, open-label, randomized clinical trial. The investigators will~     randomize 300 eligible participants in a 1:1 ratio to two different treatment regimens that~     are to be followed when using a contraceptive vaginal ring delivering a daily dose of~     Nestorone® and estradiol (NES-E2 CVR).~   "
10268|NCT03432403|"~     The purpose of this current study is to compare changes of the intracuff pressure in the~     newly designed LMA with the older design LMA after insertion of an esophagogastroduodenoscopy~     (EGD) probe in pediatric patients and adolescents.~   "
10269|NCT03432390|"~     SCENARIO: Hypoxemia is one of the most common adverse events during the induction of general~     anesthesia and may culminate with more serious complications such as cardiac arrest and~     death. Pediatric patients, due to their anatomical and physiological characteristics, are~     more likely to develop hemoglobin desaturation levels. Some preventive strategies are used~     during this period to reduce the chances of occurrence of adverse event. Continuous Positive~     Airway Pressure (CPAP) may be useful during anesthetic induction in delaying the drop in~     oxygen levels in the blood by increasing this body gas reserves. OBJECTIVES: To assess the~     effectiveness of CPAP during anesthetic induction in increasing apnea time until hemoglobin~     saturation falls to 95% in children undergoing general anesthesia for elective surgery.~     METHODS: Phase III, parallel, randomized clinical trial to be developed at the Hospital das~     Clínicas de Pernambuco. Patients (72) are divided into two groups (36 in each) in which all~     patients will spontaneously ventilate: group C will receive CPAP and group A will use the~     open system. Children of pre-school age with physical status I or II, according to the~     American Anesthesia Society, candidates for elective surgery under general anesthesia will be~     included. Patients with pre-existing parenchymal lung disease, cyanotic children or patients~     with oxyhemoglobin saturation <95% prior to anesthetic induction and recent history (<4~     weeks) or active upper respiratory tract infection will be excluded. The descriptive~     statistical analysis will be carried out through measures of central tendency and dispersion~     for quantitative variables and via distribution of frequencies for qualitative variables.~     ETHICAL ASPECTS: This work will respect human rights, principles of bioethics, the resolution~     466/2012 of the National Health Council and the statement from Helsinki. Submission and~     approval by the research ethics committee is required prior to data collection. KEY WORDS:~     Continuous Positive Airway Pressure, Hypoxia, General Anesthesia~   "
10270|NCT03432377|"~     The aim of our study is to evaluate the effect of coffee consumption on the risk of severe~     liver fibrosis in French patients with NASH.~   "
10271|NCT03432364|"~     This is a single-arm, multi-site, single-dose, Phase 1/2 study to assess ST-400 in 6 subjects~     with transfusion-dependent β-thalassemia (TDT) who are ≥18 and ≤40 years of age. ST-400 is a~     type of investigational therapy that consists of gene edited cells. ST-400 is composed of the~     patient's own blood stem cells which are genetically modified in the laboratory using~     Sangamo's zinc finger nuclease (ZFN) technology to disrupt a precise and specific sequence of~     the enhancer of the BCL11A gene (which normally suppresses fetal hemoglobin production in~     erythrocytes). This process is intended to boost fetal hemoglobin (HbF), which can substitute~     for reduced or absent adult (defective) hemoglobin, and is done without the use of~     integrating viral vectors. ST-400 is then infused back into the patient after receiving~     conditioning chemotherapy to make room for the new cells in the bone marrow, with the aim of~     producing new erythrocytes with increased amounts of HbF. The primary objective is to~     understand safety and tolerability of ST-400, and secondary objectives are to assess the~     effects on HbF levels and transfusion requirements.~   "
10272|NCT03432351|"~     Multi-center, prospective, observational study investigating the incidence of isoelectric~     electroencephalography (EEG) events and the associated peri-operative factors in infants~     0-3yo undergoing general anesthesia.~   "
10273|NCT03432338|"~     BACKGROUND:~      Non-Motor Symptoms (NMS) are frequent in patients with Idiopathic Parkinson's Disease (IPD).~     Clinical expressions, postulated pathophysiological mechanisms and responsiveness to~     antiparkinson medication represent differences between IPD and secondary Parkinsonism (SP).~      OBJECTIVES:~      To evaluate NMS expressions in IPD, SP and a control group.~      METHODS:~      Diagnosis of SP was supported by comorbidity, radiological findings, type of onset, onset~     rate and progression, exposures for neuroleptics, and responsiveness to pharmacological~     antiparkinson therapy.~      The participants were consecutively recruited at two outdoor patient clinics. The Well-Being~     Map™ for evaluation. These were completed by the participants at one point before visit. The~     controls consisted of non-Parkinsonian individuals, matched by age and gender.~   "
10274|NCT03432325|"~     This study is designed to evaluate the feasibility of The Adaptive Neural Systems~     Neural-Enabled Prosthetic Hand (ANS-NEPH) system.~   "
10275|NCT03432312|"~     The purpose of the study is to compare the pharmacokinetic (PK) profiles and assess~     bioequivalence between a new nicotine lozenge and a reference nicotine lozenge in healthy~     smokers~   "
10276|NCT03432299|"~     This is a single center prospective clinical trial with regard to efficacy and safety of~     radiofrequency ablation of papillary thyroid microcarcinoma.~   "
10277|NCT03432286|"~     The main purpose of this study is to determine the safety and efficacy of the study drug~     galcanezumab in participants 6 to 17 years of age with episodic migraine.~   "
10278|NCT03432273|"~     The purpose of the study is to compare the pharmacokinetic (PK) profiles and assess~     bioequivalence between a new nicotine lozenge and a reference nicotine lozenge in healthy~     smokers.~   "
10279|NCT03432260|"~     This is a research trial testing DUR-928 (an experimental medication). The purpose of this~     trial is to assess the dose related safety, Pharmacokinetics, and Pharmacodynamics of DUR 928~     in patients with moderate and severe alcoholic hepatitis (AH).~   "
10280|NCT03432247|"~     Chronic pain is one of the most feared symptoms in people with cancer. Insufficient relief~     from pharmacological treatments and the fear of side effects are important reasons for the~     growing use of complementary pain management approaches in cancer care. On such approach is~     music therapy. Although several studies have demonstrated that music therapy interventions~     can reduce pain in people with cancer, few studies have examined the therapeutic mechanisms~     that explain how music therapy interventions lead to improved pain management. The purpose of~     this study is to examine whether an interactive music therapy intervention improves~     psychological and social factors that play an important role in chronic pain management in~     people with advanced cancer. The findings will contribute towards the optimization of music~     therapy for palliation of chronic pain in people with advanced cancer.~   "
10281|NCT03432234|"~     The global objective of this coordinated project is to test the following hypotheses: 1) the~     lung microbiome in chronic obstructive pulmonary disease (COPD) is different in patients~     suffering from frequent exacerbations (FE) compared those who do not (NE ); 2) The microbial~     profile of patients with FE is associated with a different local and systemic inflammatory~     pattern; and 3) the inflammatory and immune characteristics of COPD are modulated by the~     intestinal microbiome.~      The project is based on bronchoalveolar lavage (BAL) for sampling lung microbiome, and~     includes analysis of regional variability (intrapulmonary) and temporal variability. The~     project will also assess the correlation between BAL samples obtained from the proximal~     airway (oral cavity, oropharynx and sputum), and the representation of lung microbiome in~     them. A cohort of COPD patients (n = 50 FE; n = 50 NE) and healthy subjects (n= 30), matched~     by age, sex and tobacco consumption. Respiratory secretion samples will be collected in~     clinical stability samples, with resampling in a quarter of the participants at 6-9 months.~     Coordinator Project: Bacterial and fungal microbiota will be determined by 16S rRNA and ITS~     amplification and sequencing. Virome and functional metagenomics will be analyzed in a~     quarter of the participants. Subprojects: Regional variability in the lung, local and~     systemic inflammatory response, and the relationship between the intestinal microbiome and~     inflammatory and clinical characteristics of the disease will be determined. The integration~     of the results will be performed using network medicine methodologies. The results of this~     project will help to understand the pathogenesis of COPD and its exacerbations with the final~     aim to identify new therapeutic targets.~   "
10282|NCT03432221|"~     Given the importance of cognitive function on depressed patients' treatment outcome and~     return to premorbid functioning, the effect of antidepressant drugs on cognition has become~     of primary concern. The aim of the present study is to assess the clinical outcome of~     switching from a selective serotonin reuptake inhibitor (SSRI) to desvenlafaxine on cognitive~     function in a Spanish sample of adults with moderate to severe major depressive disorder~     (MDD).~      This open-label clinical study will include a total of 36 MDD outpatients receiving treatment~     with desvenlafaxine according to treating psychiatrist clinical judgment.~      The primary efficacy endpoint will be changes from baseline to week 12 in cognitive function~     measured by a composite z-score comprising the Digit Symbol Substitution Test (DSST) and Rey~     Auditory Verbal Learning Test (RAVLT) scores. The secondary efficacy endpoints will involve~     depression severity, additional measures of subjective and objective cognitive function~     (including cold and hot cognitive function tasks), and functional status.~      A matched sample of 36 healthy controls will be assessed in order to obtain reference data~     for all cognitive function measurements. Patients with MDD and healthy controls will be~     compared regarding cognitive function both at baseline and after 12 weeks.~   "
10283|NCT03432208|"~     Emergency room patients referred for esophago-gastro-duodenoscopy (EGD) often have many~     possible causes for their symptoms. These inevitably undergo further testing if EGD is~     inconclusive, which adds costs and inevitably prolongs emergency room length of stay~     (LOS).EUS has traditionally been used after EGD for a myriad of costs reasons that no longer~     apply. We therefore propose a prospective pilot study to determine whether PEUS can reduce~     LOS and resource utilisation in emergency room patients referred for EGD.~   "
10284|NCT03432195|"~     A Phase 1, Crossover Study to Evaluate the Pharmacokinetics of Corplex™ Donepezil 10 mg~     Transdermal Delivery System Applied to Different Body Locations~   "
10285|NCT03432182|"~     Sleep is a key factor for normal brain development of the newborn. However, it is poorly~     studied and little is known about its characterization, especially in premature infants. Body~     movements during sleep are easy to evaluate but studies on their relationship to normal sleep~     states are scarce and limited. This project aims to characterize body movements during sleep,~     assessed by electroencephalography, in very premature infants. Then, a correlation between~     body movements, sleep organization and neurodevelopmental outcome will be evaluated at 3~     years of age.~   "
10286|NCT03432169|"~     The purpose of this study is to demonstrate the feasibility of recruiting, enrolling and~     collecting outcome data on CLBP patients within the Veterans Affairs Community Based~     Rochester Outpatient Center who undergo an 8 week active exercise class with mindfulness~     (yoga) and without mindfulness (stretching class)~   "
10287|NCT03432156|"~     Autologous Tcm cells immunotherapy combining surgery or chemotherapy could effectively~     prolong survival period and improve quality of life in patients.~   "
10288|NCT03432143|"~     Manuscripts submitted to medical journals are typically reviewed by physicians or~     researchers, with no input from patients or other community members. However, involvement of~     community members in other phases of the research process suggests that they provide distinct~     and useful expertise. Such involvement may lead to enhanced understanding of community~     priorities, refinement of study designs to minimize participant burden, and increased~     recruitment and retention of subjects.~      The investigators propose a randomized controlled trial involving 24 community members who~     will receive training and mentoring in reviewing manuscripts. A total of 568 manuscripts~     submitted to 2 medical journals will be randomly assigned to an intervention or control~     group. Intervention manuscripts will be reviewed by both a community member and by scientific~     reviewers while control manuscripts will be reviewed only by scientific reviewers. Journal~     editorial teams will use all reviews to help them make decisions about acceptance, revision,~     or rejection of manuscripts.~   "
10390|NCT03430804|"~     Transvaginal sonographic measurement of cervical length versus Bishop score in labour~     induction at term for prediction of Caesarean delivery. This study is prospective study. This~     study will be carried out in Ain-shams maternity hospital. Sample size of 320 parturients.~   "
10291|NCT03432104|"~     The aim of this study is to evaluate bioavailability and pharmacokinetics of phenolic~     compounds from Oxxynea®, a blend of fruit and vegetable extracts, in healthy volunteers,~     during a randomized, double-blind and cross-over trial. After a single dose supplementation,~     both metabolic profile and urinary excretion will be determined over a 48h-period by means of~     High-Performance Liquid Chromatography coupled with a tandem mass spectrometry (HPLC-MS) to~     identify and quantify phenolic metabolites. In parallel, post-prandial potential~     anti-oxidative and anti-glycemic properties of Oxxynea® will be determined in blood,~     following consumption of a cafeteria-type breakfast.~   "
10292|NCT03432091|"~     People who have insomnia typically co-occur with mental disorders, especially anxiety and~     depression. It has been documented that the melatonin phase in the depressed patients was~     reached with a delay. Melatonin plays a crucial role in regulation of circadian-clock-related~     gene expression.~   "
10293|NCT03432078|"~     Patients' fulfilling Rome III criteria for IBS with symptoms refractory to standard treatment~     who are referred to a specialist unit for hypnotherapy are consecutively included in the~     study. The patients are randomized to either individual or group treatment given by a nurse~     trained in hypnotherapy. The treatment consists of eight sessions of gut directed hypno~     therapy during twelve weeks. Effects are measured by validated questionnaires at baseline and~     at various time points during the treatment period as well as after the completion of the~     treatment.~   "
10294|NCT03432065|"~     The main objective of this exploratory 8-week pilot study is to evaluate the safety and~     efficacy of buspirone for the treatment of anxiety in youth (ages 6-17 years) with autism~     spectrum disorders. The study results will be used to generate hypotheses for a larger~     randomized-controlled trial with explicit hypotheses and sufficient statistical power.~   "
10295|NCT03432052|"~     Assess the recurrence of deformity after wrist Centralization in cases of radial club hand~     and effect of the procedure on the ulnar lengthening , ulnar bowing , hand function and~     parent satisfaction.~   "
10296|NCT03432039|"~     This is a randomized trial in which caregivers of children suffering from malaria will be~     assigned to two treatment conditions to prevent mental health problems in the children. A~     psycho-education arm (control) and a behavioral arm (intervention). Pre- and~     post-intervention assessments for behavioral problems in the child and mother will be carried~     out.~   "
10297|NCT03432026|"~     Chronic Obstructive Pulmonary Disease (COPD) has been defined by international guidelines as~     a common preventable and treatable disease characterized by persistent air flow limitation~     and respiratory symptoms caused by exposure to gases or noxious particles.~      COPD is a major cause of morbidity and mortality worldwide. It is predicted to become the~     third leading cause of death and the fifth leading cause of disability by the year 2020.~   "
10298|NCT03432013|"~     Emerging evidence suggests that it is not the negative affect per se but underlying~     maladaptive cognitive, behavioral, and emotional responses to it that put an individual at~     risk of pathological substance use. Maladaptive reactivity to negative affect may account for~     the association between substance-use and emotional disorders and may contribute to poor~     treatment outcomes for Substance Use Disorder. Thus, teaching adolescents and young adults~     (herein referred to as adolescents) skills to manage negative affect may improve~     therapeutic outcomes of treatment for substance use disorder. Cannabis-use disorder (CUD)~     among adolescents is a prevalent and growing public health concern. Maladaptive reactivity to~     negative affect contributes to the maintenance of CUD and accounts for the associations~     between symptoms of emotional disorders and cannabis use. Still, maladaptive reactivity to~     negative affect has not yet been targeted in an intervention for CUD. Thus, the overarching~     aim of this proposal is to develop and pilot test a treatment for CUD that emphasizes the~     reduction of maladaptive responding to negative affect in adolescents. Participants will be~     placed in either a standard cognitive behavioral therapy for CUD, or the proposed affective~     management therapy. The investigators hypothesize that affective management training will~     yield greater reductions in the participants' use of cannabis, as well as greater~     improvements to the participants' negative thoughts and emotions, compared to the standard~     cognitive behavioral therapy.~   "
10299|NCT03432000|"~     People with schizophrenia show disturbances in the perception of time. Among these~     alterations are the perturbations of the temporal order judgment. They are characterized by~     the fact that, as opposed to the general population, people with schizophrenia require a~     longer time interval between two successive stimuli to estimate which of the two events~     appeared first. If these alterations are now well documented, their consequences remain~     little explored. Among these consequences could however appear distortions of the judgment of~     causality (likely to underlie certain delusional interpretations) as well as a distressing~     experience of loss of the continuity of the lived experience (that could contribute to the~     alterations basic of self-awareness).~   "
10300|NCT03431987|"~     Alcohol is one of the most widely used intoxicants. The effects of driving while intoxicated~     are well documented, leading to the laws and regulations behind drunk driving. Marijuana is~     also a commonly abused drug, whose use is increasing with widespread~     legalization/decriminalization in many US states and use of medical marijuana. Marijuana use~     is linked to cognitive impairment and is likely be the cause of intoxication-induced~     accidents. The effects of marijuana intoxication on driving impairments are less documented~     than those of alcohol. However, most marijuana users also consume alcohol when smoking~     cannabis, and preliminary data strongly suggest that driving impairment from both drugs used~     together is synergistic rather than just additive.~      This study will aim to investigate the brain and behavior in the same individuals, using a~     similar design to the current Neuroscience of Marijuana Impaired Driving and the prior~     Alcohol and Driving Grant, that used similar techniques and measures to quantify drunk~     automobile driving. We hypothesize that alcohol and marijuana use combined will lead to~     greater impairment in a simulated driving task, as well as other driving-related cognitive~     impairments. In a randomized, counterbalanced, double-blind study, we will dose participants~     with alcohol to a legal level of 0.05% blood alcohol content, then we will administer a~     moderate inhaled dose of THC marijuana or placebo marijuana, using paced inhalation that~     employees a vaporizer. Participants will comprise 10 regular alcohol and marijuana consumers~     aged 21 to 40 years of age; all participants must report smoking marijuana and drinking~     alcohol together. Of the 10, 5 will be occasional marijuana smokers and 5 frequent marijuana~     smokers. Following this dosing, we will assess impairment through cognitive testing as well~     as a simulated driving test through fMRI and neuropsychological tests. Samples of breath,~     blood and oral fluid will also be collected at multiple time points throughout the study~     visits to be measured for alcohol and THC concentration and its metabolites. This allows~     clarification between the relationship of impairment, as well as subjective and objective~     intoxication, and levels of THC and its metabolites in the users system.~   "
10301|NCT03431974|"~     This study evaluates the treatment of psoriasis with aminopterin. Participants will be~     treated for 14 weeks with either aminopterin or placebo followed. The participants will not~     know if they are being treated with aminopterin or placebo.~   "
10304|NCT03431935|"~     Children with sickle cell disease (SCD) are living longer with the advent of medical advances~     such as prophylactic penicillin, chronic transfusion, and hydroxyurea. Despite greater~     longevity in SCD, the period following the transition from pediatric to adult care is~     critical; youth aged 18-30 years are at high risk for mortality and have high rates of~     healthcare utilization, leading to high healthcare costs. As such, health care transition~     (HCT) programs have been created to prepare patients for adult-centered care and~     subsequently, improve health outcomes. However, very few programs have been evaluated for~     effectiveness in achieving optimal health outcomes in SCD. This paucity of program evaluation~     is attributed to a lack of identifiable predictors and outcomes.~      Researchers at St. Jude Children's Research Hospital want to identify factors and patterns of~     successful HCT. This information will be used to develop approaches to best evaluate HCT~     interventions and identify areas of improvement of HCT programming.~      PRIMARY OBJECTIVE: Describe hospital utilization, treatment adherence, and health-related~     quality of life in a cohort of patients with sickle cell disease (SCD) who will transfer to~     adult care during the study period.~      SECONDARY OBJECTIVE: Examine the associations between various factors and health care~     transition (HCT) outcomes.~   "
10305|NCT03431922|"~     Endovascular arterial denervation (ED) is a minimally invasive technique which could reduce~     the occurrence of injury of visceral tissue or organs. As the principle of renal denervation~     (RDN), Radiofrequency energy delivered by a multi-electrode catheter to the celiac plexus~     over the anterolateral surface of the superior mesenteric artery (SMA) and the celiac axis.~     Damaged or partially damaged celiac plexus can achieve the effect of pain relief.~   "
10306|NCT03431909|"~     Background: Acute ischemic stroke (AIS) is a leading cause of morbidity and mortality~     worldwide. Human urinary kallidinogenase (HUK), a glycoprotein extracted from male urine~     currently used in China for enhancing cerebral perfusion5, plays a neuroprotective role~     including promoting angiogenesis, enhancing cerebral perfusion and suppressing the~     inflammatory response in animals and in patients with respect to regulating the~     kallikrein-kinin system. In previous clinical research, neurological function scores and~     cerebral perfusion scans were largely used to evaluate the efficiency of HUK. However, the~     mechanisms of Further well-conducted, randomized controlled studies using HUK are currently~     lacking.~      Objective: To assess the Human urinary kallidinogenase effects on brain metabolite and~     cerebral perfusion changes using magnetic resonance spectroscopy and CT perfusion in patients~     with AIS.~      Methods: The investigators plan to do a single-centre randomized, double-blind, controlled~     trial in which ischemic stroke patients will be randomized to treatment with either HUK or~     regular treatment within 72 hours of symptom onset. The study includes two MRS and two CTP~     scannings (before and after 2 week treatment) for all randomized subjects.~      The endpoints will include improvement of the NIH Stroke Scale (NIHSS) score from baseline,~     modified Rankin scale (mRS) score and Barthel index at 14 days.~      EvHUKMRS will test the following hypotheses:~        1. HUK enhanced N-acetylaspartate (NAA) and cerebral blood flow (CBF) 14 days after~          treatment compared with control group.~        2. HUK group compared to control group when administered 72 hours after onset of AIS~          improves recovery and functional outcome as assessed by improvement of NIHSS score , mRS~          score and BI score on day 14 post-stroke.~      A positive result will have a significant impact in the management of AIS and pave the way~     for future studies aimed at finding the optimal dose and formulation of HUK for treating~     acute ischemic stroke.~   "
10307|NCT03431896|"~     This study measures circulating, misfolded ATTR oligomers in asymptomatic ATTRm amyloidosis~     genetic carriers longitudinally over five years.~   "
10308|NCT03431870|"~     The aim of this study is to evaluate the accuracy and reliability of intra-operative TEE~     after the induction of anesthesia when assessing proximal thoracic aorta diameters in a~     cohort of aortic aneurysm patients.~   "
10309|NCT03431857|"~     This study is multicenter, prospective, non-randomized post-market. The primary objective is~     to evaluate mid-term (5-year) clinical performance of the TESS Version 2 Anatomic and Reverse~     prostheses in shoulder arthroplasty.~   "
10310|NCT03431844|"~     Objective of the study is to clarify humanin-like peptide concentration in myocard tissue and~     in blood and to study if its concentration level is related to early complication occurrence~     and frequency after cardiac operation.~      Hypothesis of the study is that previously described elements are related to each other.~   "
10311|NCT03431831|"~     Research purpose: The purpose of this pilot study is to assess obese clients for two~     phenotypes, those testing positive and those testing negative for Food Addiction (FA) (Yale~     Food Addiction Scale, YFAS) and determining the efficacy of four treatments: usual care (IC,~     dietary and physical activity instruction), individual motivational interviewing alone (MI),~     individual MI with pharmacotherapy (MI+P) for improving outcome measures within each~     phenotype, and pharmacological therapy (P).~      Background/significance: Obesity has long been an epidemic in the U.S. and other countries.~     Numerous approaches have been tried to address obesity with limited success. The YFAS is a~     relatively new, validated instrument that can help researchers and practitioners assess obese~     clients for food addiction. Meeting the YFAS diagnosis criteria for FA suggests the need for~     a stronger intervention with close monitoring to assist these clients in self-management of~     their eating and physical activity behaviors.~      Proposed methods/approach: The investigators propose assessing obese clients with the YFAS as~     part of their intake once they are referred to the Healthy Behaviors Clinic by Regional West~     physicians/practitioners. A nurse researcher with expertise in MI and a nurse practitioner~     will perform intake assessments, obtain consent and randomly assign participants in each~     phenotype (positive or negative for FA) to one of three treatment groups (usual care,~     individual MI alone, and individual MI with pharmacotherapy). Interventions will occur over 6~     months. A clinical psychologist with expertise in the YFAS (University of Michigan) will~     serve as a consultant on this project and a registered dietitian (University of~     NebraskaLincoln) will serve as a co-investigator.~      Expected outcomes: The investigators expect that MI and MI+P and P will be more effective in~     improving outcome measures than IC. We also expect that response to the treatments will~     differ between the two obesity phenotypes (those testing positive and those testing negative~     for FA).~   "
10312|NCT03431818|"~     The objective of this study is to determine the multifactorial relationship between the~     effective fraction of inspired oxygen (Effective-FiO2) and the FiO2 in the gas delivered by~     the nasal cannula (NC-FiO2), NC flow rate, spontaneous minute ventilation and other patient~     characteristics in premature infants who receive supplemental oxygen via nasal cannula (NC).~   "
10313|NCT03431805|"~     The aim is to assess the impact of tranexamic acid (TXA) for preventing postpartum hemorrhage~     (PPH) following a cesarean section (CS).~   "
10332|NCT03431558|"~     Pakistan has the third highest number of neonatal deaths worldwide. During the last two~     decades (1990-2013), neonatal mortality rate in the country has declined by only 1.0% per~     year. Severe infection is the second most leading cause of neonatal mortality, account for~     28% of all deaths in Pakistan. Majority of neonatal deaths occur in infants who LBW (birth~     weight <2500g) and LBW comprises of both preterm / small for gestational age newborns.~     Breastfeeding helps protect infants from infections by serving as a source of nutrition~     uncontaminated by environmental pathogens. The protection is due to the multiple~     anti-infective, anti-inflammatory, and immuno regulatory factors transmitted through milk~     including secretory antibodies, glycan's, Lactoferrin, leukocytes, cytokines & other~     components produced by the mother's immune system.~      Reduction in neonatal infections and deaths is the aim of this study. The study is being~     conducted at the Aga Khan University in collaboration with University of Sydney.~   "
10314|NCT03431792|"~     Congenital diaphragmatic hernia (CDH) has an incidence of 1:2200 to 1:4000 newborns. The~     survival rate depends on the extent of the lung hypoplasia and pulmonary hypertension. In~     case of an observed / expected total fetal lung volume ratio (o/e TFLV) ratio of 25% or lower~     and herniation of the liver in thorax, the postnatal survival is estimated to be 10-25% or~     lower. The aim of fetoscopic tracheal balloon occlusion is to positively influence the lung~     growth in CDH fetuses avoiding the development of lung hypoplasia.~      Some complications after sucsessfull FETO before delivery occur because of technical~     difficulties during the extraction of the balloon from the trachea, leading to asphyxia,~     worse outcome or neonatal demise. Jani et al. published 10 neonatal deaths from 210 FETO~     directly related to difficulties with the removal of the intratracheal balloon. The risk of~     emergent balloon removal was published to be very high (39%-56%).~      Our new technique exploits the fetal ability to removal the intratracheal balloon which has~     been implanted for the treatment of severe CDH before the delivery, avoiding many risks~     associated with balloon extraction and a second fetoscopy.~      The study will be performed on 20 fetuses with severe CDH. Before the FETO the total fetal~     lung volume ratio (o/e TFLV) will be measured by fetal MRI (magnetic . Only CDH fetuses with~     24-32 weeks' gestation with o/e TFLV < 25% or the fetuses with o/e TFLV < 35% and liver~     herniation will be operated Second fetal MRI should be performed in one week after the FETO.~     The balloon will be extracted by the fetus itself before the delivery, after puncture with 22~     gauge needle under ultrasound guiding, during second fetoscopy or using the EXIT (ex utero~     intrapartum Treatment). Neonatal follow up 12 months.~   "
10315|NCT03431779|"~     The investigators would like to investigate if lipofilling with its adipose derived stem~     cells (ADSC) could be a new, less invasive but equally or more effective therapeutic option~     for women with vestibulodynia than vestibulectomy. The investigators expect the study to be~     successful because of the anti-inflammatory effects of the ADSC and its effectiveness~     -although not thoroughly studied- in some neuropathic pain disorder like pudendal neuralgia~     or post mastectomy pain syndrome.~      Method: A controlled intervention study: one group receiving golden standard therapy~     'vestibulectomy' and one group receiving vestibular lipofilling.~   "
10316|NCT03431766|"~     The objective of this human randomized, double blind, placebo-control (RDBPC) study is to~     evaluate the efficacy of a 0.2% chlorhexidine (CHX) gel on reducing bacterial load and~     peri-implant inflammation at implant-abutment interface during the early healing~     stage.Thirty-six healthy patients (mean age 52,28 years; range 29-75 years) without a~     significant past medical anamnesis, all non-smokers, will be recruited as candidates for~     single implant placement and prosthetic rehabilitation.Patients will be randomly divided in~     group A (control) and group B (test) as indicated by the randomization chart. All Implants~     (Cortex classic, Shalomi, Israel)would be inserted by two skilled operators who followed a~     two-stage protocol and placed them according to the manufacturer's instructions.Eventually,~     all patients will be rehabilitated with a single implant-supported crown. During all the~     stages either a gel containing 0.20% CHX (Plak ®Gel; Polifarma Wellness Srl, Rome, Italy) or~     a placebo gel (Placebo, Polifarma Wellness Srl, Rome, Italy) will be used. The two gels are~     perfectly alike in packaging, color and smell and nobody knew the exact location of placebo~     or test gel, which will be revealed, only after data collection would be performed, by the~     person who prepared them. A or B gel will be placed on the internal connection abutments and~     then a cover screw would be inserted. Finally, the site would be sutured with non-absorbable~     nylon sutures. Cone Beam Computed Tomography evaluation (CBCT) (VatechIpax 3D PCH-6500, Fort~     Lee, NJ USA) would be performed both for pre-operative and post-surgical implant placement.~     Both gels will be given to the patients, according to the protocol, and applied 2 times/day~     until suture removal after 7 days. Soft tissue biopsies would be performed by means of a~     circular scalpel (5.5 mm in diameter) at the implant insertion (T0) and after two months of~     healing (second stage surgery)(T1) to analyze the peri-implant inflammatory infiltrate and~     the micro-vessel density (MVD) in both groups. All the radiographs taken during the study~     time points would be analysed to measure the bone resorption after 1 year or on other studt~     time points.~   "
10317|NCT03431753|"~     Prostate cancer (PC) is the most common malignancy (4500 new cases/year) and the second~     leading cause of cancer-associated mortality (1200 deaths/year) among men in Denmark. PC is~     generally diagnosed on the basis of an elevated prostate specific antigen blood test followed~     by transrectal ultrasound (TRUS)-guided prostate biopsy.~      This study aims to test early detection of PC in general practice, using the STHLM3 model~     with superior specificity and sensitivity for clinically significant PC, combined with~     multiparametric magnetic resonance imaging (mpMRI) of the prostate and MR guided biopsy.~   "
10318|NCT03431740|"~     The investigators aim to investigate the impact of thoracic radiation therapy on diffusion~     capacity of the lung (primary endpoint: diffusion capacity for nitric oxide, DLNO) and on~     exhaled nitric oxide.~   "
10319|NCT03431727|"~     The aim of the study is to investigate sleep apnea, circulation and metabolism in acromegaly~     before and after surgery and/or medical treatment.~   "
10320|NCT03431714|"~     The World Health Organization recommends regular surveillance of antimalarial efficacy to~     monitor the performance of different drugs. The Tanzanian National Malaria Control Programme~     (NMCP) in collaboration with its partners have been implementing therapeutic efficacy studies~     (TES) to monitor the performance of different antimalarials in the country. Most of the~     studies conducted in recent years focused on artemether-lumefantrine which is the first line~     antimalarial for the treatment of uncomplicated malaria in Mainland Tanzania. However, data~     on the performance of other artemisinin based combination therapy (ACTs) is urgently needed~     to support timely review and changes of treatment guidelines in case of drug resistance to~     current regimen. This study was undertaken in the same NMCP framework to assess the efficacy~     and safety of alternative ACTs used or with potential use in Tanzania. The study assessed the~     efficacy and safety of artesunate-amodiaquine (ASAQ) and dihydroartemisinin-piperaquine (DP)~     for the treatment of uncomplicated malaria in Tanzania. The study was undertaken at two NMCP~     sentinel sites of Kibaha and Ujiji from July to December 2017.~   "
10333|NCT03431545|"~     The purpose of this study is to learn whether a combination of two research-proven programs,~     a responsive caregiving parenting program and a teacher training program, will have an effect~     on infants' and toddlers' language, cognitive, social-emotional, and self-regulation skills.~     The interventions are designed to specifically target parent use of a responsive, stimulating~     caregiving style in the home in combination with teacher instructional practices and the use~     of a responsive interactive style in the classroom.~   "
10391|NCT03430791|"~     Phase II trial in which participants with bevacizumab-naïve, recurrent glioblastoma will~     receive a combination of tumor treating fields(portable device), nivolumab with or without~     ipilimumab.~   "
10392|NCT03430778|"~     The primary purpose of this study is to investigate the effect of pneumoperitoneum on the~     continuous and non-invasive hemoglobin monitoring during laparoscopic gastrectomy~   "
10321|NCT03431701|"~     Background: Women undergoing cesarean delivery have 5 to 20 fold greater risk for infection~     and infectious morbidity compared with those undergoing vaginal birth. Endometritis, febrile~     morbidity, and wound infection are the most frequent complications of post cesarean~     infections. Endometritis accounts for 6-27% followed by clinically significant fever, which~     was reported about 5-24%,while the incidence of wound infection is about 2-9%.Previous~     studies evaluated whether vaginal cleansing can reduce the incidence of postoperative~     infectious morbidity. In most of the studies, povidone iodine was used as intervention.~      Objectives: The aim of this study is to test the hypothesis that preoperative vaginal~     cleansing with chlorhexidine would be superior to iodine for the prevention of maternal~     infectious morbidities including endometritis, fever and wound complications.~      Methods: This prospective randomized single blinded controlled trial will be conducted at~     Makassed General Hospital between February 2018 and January 2019. Total of 300 patients, 150~     in each group, will be enrolled. Group 1 patients will receive chlorhexidine vaginal~     cleansing while group 2 patients will receive iodine prior to C-section. Adverse post~     infectious morbidities such as endometritis, febrile illness and wound infections will be~     observed within 30 days of C-section.~   "
10322|NCT03431688|"~     Clarithromycin-resistant H. pylori is the main cause of H. pylori eradication failure.~     Tailored therapy on the basis of detection of a clarithromycin resistance mutation by PCR has~     been studied recently, however, there have been few studies comparing treatment regimen in~     patient with clarithromycin-resistant H. pylori. We used sequencing-based clarithromycin~     resistance mutation and aimed to compare PAM (proton pump inhibitor, amoxicilline,~     metronidazole) regimen and PBMT (proton pump inhibitor, bismuth, metronidazole, tetracyclin)~     regimen in patient with clarithromycin-resistant H. pylori.~   "
10323|NCT03431675|"~     The trial is an interventional, cluster-randomized trial to assess the impact of oral~     ciprofloxacin for household and community contacts of meningitis cases on the incidence of~     meningitis during an epidemic.~      The trial contains a nested sub-study (resistance study) to assess the effect of a single~     dose of ciprofloxacin on the prevalence of fluoroquinolone-resistant enterobacteriaceae in~     the study area.~   "
10324|NCT03431662|"~     The purpose of this study is to assess whether there is a difference between the TomoFix and~     Ellipse Intramedullary HTO Nail System in terms of bone regeneration in the tibial wedge by~     performing a CT-scan at 3 and 6-months postoperatively.~   "
10325|NCT03431649|"~     To analyze the efficacy of beraprost and sildenafil for treatment of pulmonary hypertension~     in children with left to right shunt.~      analyze the efficacy and side effects.~   "
10326|NCT03431636|"~     Para-athletes are submitted and intense efforts in training and competitions that often~     overlap in days and weeks. In this sense, and in the search for better brands and indexes, it~     is necessary to use recovery methods that allow less late muscle pain and better physical~     performance. Recovery methods are widely used in athletes of various modalities, however~     there are no studies that point out their effects on para-athletes. This highlights the need~     for studies on this topic. Paragliding athletes, who train at the Londrina Yacht Club,~     Londrina Canoeing and Rowing School, who present paraplegia after spinal cord injury, with~     motor level T10 or lower, without any problem of thermoregulation will participate in the~     study. All were male and female, with no complaints of musculoskeletal pain or history of~     upper limb muscle injuries in the last six months and with the same demand for training and~     competitions. Initially an evaluation will be performed where 1RM, VO2 max, pain, spasticity,~     body temperature, heart rate variability and electromyographic signal of the involved muscles~     will be tested. After three days they will be induced to fatigue through a protocol in the~     traction exercise and immediately directed to one of the 3 intervention groups: ice pack,~     immersion in cold water or rest. The same baseline evaluations will be repeated after 24, 48~     and 72 hours. It is expected that the group submitted to immersion in cold water presents~     better parameters for pain and sports performance.~   "
10327|NCT03431623|"~     The aim of this study was to compare and evaluate efficacy and safety of subcutaneous~     CKD-11101 versus Darbepoetin alfa in patients who have renal anemia not on dialysis.~   "
10328|NCT03431610|"~     This is a Phase 1b, 2-week study assessing the pharmacokinetics, pharmacodynamics, safety and~     tolerability of SB414 in subjects with mild to moderate AD.~   "
10329|NCT03431597|"~     This micronutrient supplementation study is a 3-arm randomized controlled trial, unblinded,~     with 125 women per arm. Non-pregnant, non-lactating healthy women of reproductive age in West~     Kiang, The Gambia, will be randomized to 12 weeks of daily supplementation of either a) novel~     micronutrient supplement, b) a United Nations International Multiple Micronutrient~     Preparation (UNIMMAP) tablet or c) no intervention (control). The novel micronutrient~     supplement is a drink powder providing 800 µg folic acid, 5.2 µg cyanocobalamin (B12), 2.8 mg~     Riboflavin-5'-phosphate (B2), and 4g trimethylglycine (betaine). UNIMMAP contains 15~     micronutrients at the Recommended Daily Allowance level. The aim is to test the effectiveness~     of the supplements on correcting micronutrient deficiencies in the dry season and to reduce~     homocysteine levels. The hypothesis is that the new drink powder will be the most effective~     supplement, causing a reduction in 1 µmol/L compared to the control group after~     supplementation.~      The supplements will be supplied to participants on a daily basis by Community-based Birth~     Attendants (CBCs). The CBCs will observe consumption of the supplement. The novel~     micronutrient supplement will be provided in powder form with instructions to dissolve one~     sachet in a cup of 200ml water. UNIMMAP will be provided in capsule form to be taken with~     water. Women will provide one 10ml fasted venous blood sample at baseline and another after 6~     and 12 weeks of supplementation. At each time point they will also have their blood pressure~     and anthropometry assessed and provide a urine pregnancy test.~      Correcting micronutrient deficiencies is extremely important for the long-term health of~     women, and in particular around the time of conception and throughout pregnancy since~     micronutrients are needed for the proper physical and cognitive development of the baby.~     Certain micronutrients are required for adding a methyl group to places on DNA ('DNA~     methylation'). The pattern of these methyl groups can help determine whether a gene is~     switched on or off. Correct functioning of DNA methylation processes is therefore of critical~     importance for fetal development. High levels of homocysteine can impede DNA methylation,~     therefore supplements that reduce homocysteine may not only be beneficial for the mother but~     also for the developing child. The most effective supplement in this trial will be considered~     for testing in larger pregnancy trials.~   "
10330|NCT03431584|"~     The rhizarthrosis, or the degenerative osteoarthritis of the trapezo-metacarpal joint, is a~     frequent degenerative osteoarthritis.~      The treatment associates not pharmacological measures, such as resting relative of the joint,~     the orthosis of rest, glazing and pharmacological measures such analgesic, anti-inflammatory~     not steroidal per bones or premises, even infiltrations cortisone or by hyaluronic acid.~      No study has, for the moment, tested the interest of the combination of cortisone and~     hyaluronic acid in rhizarthrosis. In view of the current publications, we propose to carry~     out a study on two arms, with corticosteroids in reference arm; the experimental arm is the~     combination of hyaluronic acid and cortisone.~   "
10331|NCT03431571|"~     The correction of farsightedness using ReLEx SMILE for hyperopia is focus of this~     investigation. The objective is to evaluate the safety and effectiveness.~   "
10334|NCT03431532|"~     The impact of different anesthetic techniques on the immune system remains unclear.~      Aim of this ex vivo / in vitro study was to determine the effects of general and neuraxial~     anesthesia on monocyte subset alteration and the release of prototypical pro- and~     anti-inflammatory cytokines. Twenty patients undergoing total knee replacement surgery were~     randomly assigned to receive either general anesthesia (ITN) or combined spinal/epidural~     anesthesia (CSE). CD14 and HLA-DR expression patterns on monocytes and intracellular~     TNF-alpha production were quantified via flow cytometry. TNF-α and IL-10 release were~     measured via enzyme linked immunosorbent assay (ELISA).~   "
10335|NCT03431519|"~     The aim of this study was to examine the short- to medium-term efficacy of percutaneous~     vertebral body reconstruction by vertebral body augmentation with Sr-HA paste plus~     short-segment pedicle screw fixation in fresh fractures, as well as to evaluate Sr-HA~     resorption/substitution. The hypotheses tested in this study were as follows: 1) whether~     Sr-HA is equivalent to PMMA for restoring the fractured thoracolumbar vertebral body, 2)~     whether leakage of Sr-HA is less than that of PMMA, and 3) whether Sr-HA is completely~     resorbed and replaced by cancellous bone.~   "
10336|NCT03431506|"~     To evaluate the vestibular function and vestibular rehabilitation in sudden sensorneural~     hearing loss(SSHL) with vertigo~   "
10337|NCT03431493|"~     More and more people are surviving after receiving life support for respiratory failure in~     the intensive care unit, but these patients often experience problems with depression and~     physical functioning that lead to reduced quality of life. There is a lack of treatment for~     these patients, with past research suggesting that treatment may be more successful if mental~     and physical health are addressed at the same time. This research evaluates whether a therapy~     delivered via telephone and home visits, combining treatment for depression and physical~     rehabilitation, is feasible and might help patients recover.~   "
10338|NCT03431480|"~     This study aims to evaluate the safety and feasibility of coronary infusion of autologous~     placental cord blood mononuclear cells during the Norwood heart operation in newborn~     hypoplastic left heart syndrome (HLHS) patients.~   "
10339|NCT03431467|"~     Veno-arterial extra-corporeal membrane oxygenation (VA-ECMO) is indicated as a haemodynamic~     rescue strategy in decompensated acute or chronic heart failure presenting as cardiogenic~     shock. It has been used across aeitologies including post-myocardial infarction, dilated~     cardiomyopathy, acute myocarditis and in post-cardiotomy shock. VA ECMO has a number of~     effects on the circulation including improved end-organ perfusion and possibly improved~     coronary perfusion, and is a bridge to further therapies including permanent advanced~     mechanical circulatory support, cardiac transplantation and to cardiac recovery.~      Left ventricular assist devices (LVADs) provide long-term mechanical circulatory support and~     also profoundly mechanically unload the left ventricle. Multiple clinical studies have~     documented cardiac recovery using LVAD therapy, with a rate between 10-60% in selected~     populations. A large body of basic science has documented the pivotal role of mechanical load~     in determining ventricular contractile performance across species. Therefore both clinical~     data and basic laboratory studies support the notion that profound ventricular unloading may~     result in improved cardiac performance through a variety of mechanisms ranging from triggered~     de novo cardiomyocyte proliferation, subcellular calcium handling reverse remodeling, changes~     to the extracellular matrix of the heart, reverse remodeling of the neurohormal milleu,~     amongst many others.~      One of the major deficiencies of peripheral VA-ECMO is its lack of left ventricular~     unloading, with associated pulmonary congestion, which can derail clinical improvement and~     hamper cardiac recovery. Indeed, percutaneous VA-ECMO increases LV afterload due to the~     retrograde blood flow, and because of the lack of venting, there may be progressive LV~     distension. These conditions can result in a congested, pressure-overloaded ventricle, even~     in the absence of echocardiographic ventricular distension. This may be ameliorated with the~     addition of ventricular mechanical unloading using percutaneous therapies including the~     percutaneous left ventricular device, Impella CP.~      On the platform of VA-ECMO, the addition of an Impella device to reduce ventricular loading~     results in improved survival and recovery of ventricular performance in the setting of~     cardiogenic shock. In a number of small studies, the use of additional means to unload the~     ventricle, principally Impella, results in cardiac recovery and less ventricular distension.~     In chronic heart failure, direct ventricular unloading is critical to cardiac recovery.~      The objective of this randomized study is to determine whether the addition of early direct~     ventricular unloading using Impella CP leads to higher rates of cardiac recovery, defined as~     survival free from mechanical circulatory support, heart transplantation or inotropic support~     at thirty days. This study will also examine the clinical, biochemical, echocardiographic and~     radiologic effects of VA ECMO with and without the addition of Impella CP to directly vent~     the left ventricle to address adjunct important questions such as the effects on pulmonary~     congestion.~   "
10340|NCT03431454|"~     We compared the effectiveness of three active vision therapy approaches for convergence~     insufficiency (CI). Patients with eligible criteria and symptomatic CI were included in a~     prospective study and randomly allocated into three groups. In the home-based vision~     orthoptic therapy (HBVOT) group, patients were trained to do the pencil push-ups procedure 15~     minutes per day, five days a week. In the office-based vision orthoptic therapy (OBVOT)~     group, 60 minutes of orthoptic therapy using a major amblyoscope twice weekly with additional~     home orthoptic therapy was prescribed. For the augmented office-based vision orthoptic~     therapy (AOBVOT) group, orthoptic exercises using three diopter over-minus lenses and a base~     out prism, in addition to major amblyoscope and additional home reinforcement was prescribed~     in the same period of time.~   "
10341|NCT03431441|"~     This will be a single site, non-randomized, dispensing, brand-masked to the subject,~     bilateral single treatment study. There will be 2 study visits with a 10 to 14-day contact~     lens wear period between visits.~   "
10342|NCT03431428|"~     The aim of this study is evaluate the effect of two different surgical treatment on lower~     rectal cancer after almost clinical complete response(almost-cCR). All almost clinical~     complete response(almost-cCRs) were entered into two groups randomly. The estimated sample~     size of the minimal operation group was 221, and 221 in the Mile's group. Three years'~     progression-free survival(PFS) and overall survival(OS) were compared.~   "
10343|NCT03431415|"~     The primary objective of this study is disease free survival rate at 5 years in stage IA2~     (T1aN0M0 or T1bN0M0 only) non-small cell lung cancer (NSCLC) patients treated either by~     surgery or stereotactic body radiation therapy (SBRT).~   "
10359|NCT03431207|"~     An individual senses the world and reflects feedbacks via independent behaviors. Such precise~     collaboration of the sensory and behavioral systems is fundamental to survival and evolution.~     When a sensory modality is altered, the behavioral system has the potential to fit in a~     substitute modality. However, the specific dynamics of human behaviors in response to sensory~     loss remain largely unknown due to the paucities of representative situations and large-scale~     samples.~      Here, the investigators focused on thousands of human infants who suffered varying degrees of~     visual stimuli deficiency in early stages, while their behavioral systems remained sensitive~     and thus retained high behavioral plasticity. Having access to this unique population~     provides an unprecedented opportunity to investigate the effect of diverse visual conditions~     on the behavioral system.~   "
10360|NCT03431194|"~     The aim of this randomized trial was to assess the efficacy of oral midodrine tablets for the~     management of intradialytic hypotension among critically ill patients with acute kidney~     injury.~   "
10361|NCT03431181|"~     We have designed OVATION-65 to evaluate the effects of permissive low blood pressure compared~     to usual care on markers of organ injury and survival in older patients.~   "
10344|NCT03431402|"~     Background and Rationale:~      Cerebrovascular disease is always ranked at the top causes of death and most of hospitalized~     acute stroke patients have ischemic stroke [1].~      Although the mortality rate of acute ischemic stroke is less than that of hemorrhagic stroke~     [1], it still results in patient disabilities and complications that often lead to~     significant costs to individuals, families, and society.~      Traditional treatment for acute ischemic stroke includes thrombolytic therapy by injecting~     tissue plasminogen activator (t-PA) within three hours after onset of symptoms [2],~     antiplatelets and/or anticoagulant agents administered within the first 48 hours. Clinically,~     the narrow time window of thrombolytic therapy and coexisting contraindications limit the use~     of t-PA [2]. Thus, searching for an effective supplemental treatment for acute ischemic~     stroke is imperative.~      Hyperbaric oxygen therapy (HBOT) is valuable in treating acute carbon monoxide poisoning~     [3,4], air or gas embolism [5], facilitating wound healing [6] and has been used as an~     adjuvant treatment for many neurological disorders that need further study as concussion [7]~     , stroke [8,9], cerebral palsy [ 10],traumatic brain injury [ 11], cerebral air embolism~     [12], Autism [13] and multiple sclerosis [14].~      Indications of hyperbaric oxygen therapy recommended by undersea and hyperbaric medical~     society (UHMS) [15] are 1.air or gas embolism [5], 2.carbon monoxide poisoning [3,4],~     3.clostridial myositis and myonecrosis [16], 4.crush injury, compartment syndrome and other~     acute traumatic ischemias [17], 5.decompression sickness [18], 6.arterial insufficiencies~     [19], 7.severe anemia [20], 8.intracranial abscess [21], 9.necrotizing soft tissue infections~     [22],10. refractory osteomyelitis [23], 11.delayed radiation injury [24], 12.compromised~     grafts and flaps [25], 13.acute thermal burn injury [26] and 14.idiopathic sudden~     sensorineural hearing loss [27].~      Known mechanisms of HBOT-induced neuroprotection include enhancing neuronal viability via~     increased tissue oxygen delivery to the area of diminished blood flow, reducing brain edema,~     and improving metabolism after ischemia [28,29]. Furthermore, a recent study performed on a~     rat suggested that upregulation of the expression of glial derived neurotrophic factor (GDNF)~     and nerve growth factor (NGF) might underlie the effect of HBOT [30].~      The effectiveness of use of Hyperbaric oxygen therapy in human ischemic stroke is still~     controversial that need further evaluation.~   "
10345|NCT03431389|"~     This study was undertaken to Identify the factors affecting the outcomes of tracheostomy done~     in ICU for patients subjected to prolonged intubation and ventilation and to suggest~     guidelines to control:~        1. proper timing of tracheostomy~        2. process of decannulation.~   "
10346|NCT03431376|"~     Government has popularized potatoes as a major staple food in China. Potato, a potassium-rich~     food with high glycemic responses after consumption, exhibits unclear effects on~     hypertension. In this study, the investigators aimed to examine the association between~     potato consumption and hypertension risk among Chinese people.~   "
10347|NCT03431363|"~     The primary purpose of the study is to observe the adherence and health seeking behavior of~     patients with Head and Neck cancer (HNC) certified to obtain medically certified cannabis as~     part of their supportive care regimen undergoing treatment with definitive or adjuvant~     concurrent chemoradiation (CRT).~   "
10348|NCT03431350|"~     The purpose of this study is to establish the recommended phase 2 dose (RP2D) of niraparib~     combination therapies of Part 1 and to evaluate the antitumor activity and safety of~     niraparib combination therapies of Part 2.~   "
10349|NCT03431337|"~     Comparative-effectiveness study of the treatment of acute bacterial sinusitis with~     amoxicillin/clavulanate 875mg/125mg bid for 7 days with or without the addition of~     immediate-release amoxicillin 875 mg bid x 7 days. .~   "
10350|NCT03431324|"~     The current proposal aims to develop and establish the effectiveness of a novel behavioral~     smoking cessation intervention. Previous research has shown that having smokers engage in~     episodic future thinking (EFT) about specific positive life outcomes that they could~     experience if they quit smoking immediately can be an effective means of reducing cigarette~     consumption. This intervention allowed participants to generate their own general positive~     life outcomes. While the existing intervention approaches motivation from a generalist~     perspective, the current proposal seeks to modify this intervention to fit within a~     Fundamental Social Motives (FSM) framework. The FSM framework posits that there exist~     individual differences in fundamental social motives such as self-protection, disease~     avoidance, affiliation, kin care, and mating motives such that some individuals are more~     motivated to work toward some of these goals than others. Specifically, the current proposal~     seeks to develop an EFT intervention that appeals to fundamental mating motives by asking~     participants to imagine positive mating outcomes that they might experience in one year's~     time if they were to quit smoking immediately. This will be accomplished via two empirical~     studies. Study 1 will compare the effectiveness of the mating-EFT intervention to the~     general-EFT intervention and a yoked control condition while examining the possibility that~     individual differences in relationship status, mating motives, self-efficacy, and nicotine~     dependence moderate these effects. Study 2 will employ a quasi-experimental design to test~     the effectiveness of this intervention using a tailored messaging approach, assigning smokers~     who are either single and motivated to seek new mates or involved in a committed relationship~     and not motivated to seek new mates to complete the general or mating-EFT or a control task.~     The investigators predict that the mating-EFT will be more effective than the general EFT in~     reducing cigarette consumption, particularly if it is administered to participants who have~     more active mating goals.~   "
10351|NCT03431311|"~     T Cell Receptor Based Therapy of Metastatic Colorectal Cancer With mRNA-engineered T Cells~     Targeting Transforming Growth Factor Beta Receptor Type II (TGFβII)~   "
10352|NCT03431298|"~     The study purpose is to explore the effect of functional movement control for patients who~     have stage II or III degenerative knee joint disease and also physical inactive. Half of~     patients will receive aerobic exercise and functional movement control training in~     combination, while the other will simply receive aerobic exercise.~   "
10353|NCT03431285|"~     Investigators hypothesize that administration of ketamine for pain relief in sickle cell~     patients with vaso-occlusive crisis early on will lead to a more rapid improvement in pain~     score and less narcotic requirement.~   "
10354|NCT03431272|"~     Discomfort with contact lens wear is the biggest reason why people stop wearing contact~     lenses. The investigators believe that inflammation is one of the causes of discomfort, and~     by blocking the inflammation using lifitegrast, the investigators may be able to relieve some~     of that discomfort. This study will enroll 50 subjects with contact lens discomfort and will~     receive lifitegrast to use over a period of approximately 3 months.~   "
10355|NCT03431259|"~     This study aims to determine if inpatient enrollment into a patient communication app~     improves clinic follow-up of orthopedic trauma patients and improves survey completion rates~     after orthopedic trauma.~   "
10356|NCT03431246|"~     This study will assess the immunogenicity of one dose of Gardasil and one dose of Gardasil-9~   "
10357|NCT03431233|"~     The aim of this study is to explore premeal protein-enriched bar effect in food intake in~     healthy subjects.~   "
10358|NCT03431220|"~     A study in which subjects with a Grade 1 or Grade 2 open abdomen that require the use of NPWT~     for temporary abdominal closure. Subjects will use the NPWT system for up to 14 days, with a~     21 day post study initiation follow-up assessment for latent complications and mortality.~   "
10362|NCT03431168|"~     More than 3 billion people worldwide are at risk of acquiring malaria and pregnant women~     living with HIV in Africa are at particular risk. An effective prophylaxis regimen capable of~     preventing malaria and other common perinatal infections would have great potential to~     improve adverse birth outcomes. The purpose of this randomized controlled trial is to~     evaluate a new combination prophylaxis regimen in pregnant women with HIV in Cameroon to~     determine its efficacy and safety.~   "
10364|NCT03431142|"~     Current guidelines recommend that patients with ACS undergoing stent implantation might be~     offered extended DAPT treatment for up to 30 months if necessary.~      Therefore, we designed a prospective, multicenter, randomized, placebo-controlled trial among~     ACS patients with high-risk on ischemic and bleeding who received a new generation of DES and~     received 9 to 12 months of DAPT, and evaluated whether clopidogrel monotherapy reduce the~     risk of bleeding compared with clopidogrel plus ASA in the following 9 months and achieved~     non-inferior outcomes in preventing ischemic risk.~   "
10365|NCT03431129|"~     The purpose of this work is to perform hyperpolarized (HP) 129Xe MRI in human subjects~     undergoing thoracic radiation therapy (RT), both before, during and following RT. HP 129Xe MR~     images will be analysed to provide maps of ventilation (V), perfusion (Q), apparent diffusion~     coefficient (ADC) and gas exchange. These results will be combined to yield a new measure of~     RILI, (i.e. dose volume histograms; DVHV/Q) and compared with conventional dose volume~     histograms (DVH), pulmonary function tests (PFTs), quality of life (QOL) questionnaire and CT~     measurements for assessment of RILI at each time point. The aim is to development a novel~     method for early and more sensitive method of detecting RILI before irreversible lung damage~     happens.~   "
10366|NCT03431116|"~     Placenta Previa is defined as a placenta implanted in the lower segment of the uterus,~     presenting ahead of the leading pole of the fetus (over or near the internal os). The~     prevalence of placenta previa has been estimated to be approximately 0.5% of all pregnancies,~     and this increase correlates to the elevated cesarean section rate . In Egypt, the prevalence~     of placenta previa is around 1.3% in Sohag Governorate and 1.5% in Aswan region according to.~      Although various studies have tried to address risk factors associated with Placenta Previa~     development, the etiology of placenta previa still remains obscure. Several risk actors have~     been identified as strong contributors to placenta previa development. It is also a~     significant contributor to severe postpartum hemorrhage.Risk factors include; history of~     previous cesarean section, advanced maternal age, history of previous abortions, high parity~     and substance abuse during pregnancy (cigarette smoking), placental size (multiple~     pregnancy), endometrial damage (previous dilatation and curettage), uterine scars and~     pathology (previous myomectomy or endometritis), placental pathology (marginal cord~     insertions and succenturiate lobes), previous placental Previa, and curiously.~   "
10367|NCT03431103|"~     The overlap syndrome (OS), i.e. the association of both Chronic Obstructive Pulmonary Disease~     (COPD) and Obstructive Sleep Apnea (OSA) in a single Veteran, is prevalent and associated~     with increased cardiovascular disease (CVD) morbidity. Home-based exercise interventions that~     translate to a lifestyle with increased physical activity (PA) are an ideal strategy as 150~     minutes of leisure time PA a week is associated with a significant reduction in risk of CVD~     related events and death. This novel research study will help develop a home exercise~     intervention that is largely accepted by OS Veterans, as a first step toward implementing PA~     into the routine medical care of the large Veteran population with COPD and OSA. This data~     will be used for larger studies on CVD risk and its modification with exercise in OS, a~     research area that is urgently needed given its high impact on Veterans' morbidity, mortality~     and health-care associated costs.~   "
10368|NCT03431090|"~     This is a Phase I/II study designed to evaluate the kinetics of hematopoietic reconstitution~     and the incidence of acute chronic GVHD after partially matched related donor hematopoietic~     cell transplantation using an αβTCR/CD19+ cell depleted graft.~   "
10369|NCT03431077|"~     The objective of this study is to evaluate the effect of LJPC-501 infusion on mean arterial~     pressure (MAP) or reduction in sum norepinephrine (NE) equivalent dosing, at Hour 2 after the~     start of LJPC-501, in pediatric patients who remain hypotensive despite receiving fluid~     therapy and vasopressor therapy. In addition, this study will evaluate the safety and~     tolerability of LJPC-501 in pediatric patients, the change in MAP over 24 hours after the~     start of LJPC-501, the change in serum lactate concentrations, and the change in Pediatric~     Logistic Organ Dysfunction (PELOD) scores.~   "
10370|NCT03431064|"~     In this research study we want to learn more about using non-invasive tools as a way to~     predict whether or not a child under general anesthesia will require and respond to fluid~     administration.~      It is important for an anesthesiologist to know if a child would respond to fluid~     administration so that they can provide the optimal intervention for low blood pressure and~     avoid unnecessary treatment.~   "
10371|NCT03431051|"~     The study is designed to determine if instituting a Healthy Beverage Initiative (HBI) at~     hospitals influences health and wellness of employees over a 12 month period.~   "
10372|NCT03431038|"~     This study explore AAA prevalence in OSAHS patients by ultrasound screening and try to~     analysis risk factors of AAA in OSAHS patients.~   "
10373|NCT03431025|"~     Stroke and other causes of central nervous system damage can result in debilitating loss of~     motor control that is often more pronounced in one limb than the other. Using or attempting~     to use the affected limb during activities of daily living, despite considerable difficulty,~     stimulates neuroplasticity and motor function recovery. The investigators are conducting a~     clinical study to test the efficacy of wrist-worn sensors that encourage affected limb use~     during activities of daily living.~   "
10374|NCT03431012|"~     During the last pandemic influenza antivirals were prescribed both as prophylaxis and~     treatment. However, adherence rates were suboptimal. This study assessed the effect of~     theory-based and evidence-based health messages, which promoted the use of antivirals as~     prophylaxis for pandemic influenza, on intentions to use antivirals. Using hypothetical~     scenarios, the investigators tested whether written health communications about pandemic flu~     and recommended preventative medication (i.e. a prophylactic treatment with antivirals) had~     an effect on study participants' beliefs about the pandemic flu and the advice received, and~     their intention to adhere to the recommendation. In particular, the investigators assessed~     the behavioural impact of health messages presented in four different linguistic formats,~     defined by a 2×2 (agency assignment × attribute framing) factorial design. The originality of~     this study relies on the attempt to maximise the behavioural impact of written health~     messages by combining the agency assignment and attribute framings, which have never been~     tested together, and by systematically targeting specific predictors of adherence intentions~     through these messages. The findings of this study may be used to improve the behavioural~     impact of health communications to the general public in case of a pandemic flu outbreak in~     the UK.~   "
10377|NCT03430973|"~     Driving a car is the most dangerous behavior most people engage in every day. According to~     the World Health Organization, about 1.25 million people die each year as a result of road~     traffic crashes, and they are the leading cause of death among 15 to 29 year olds. According~     to the National Highway Traffic Safety Administration, 37,461 Americans were killed in motor~     vehicle crashes in 2016 — about 103 per day. Although there are several causes of traffic~     crashes (e.g., texting, alcohol consumption, inclement weather), the leading cause is~     aggressive driving. In the United States, aggressive driving accounts for more than half of~     all traffic fatalities. Thus, aggressive driving is an important applied health topic,~     especially for young drivers.~   "
10378|NCT03430960|"~     -  Purpose The general purpose of this project is to assess the utility of the mCare~          application and MHCE (Mobile Healthcare Environment) system - a secure, mobile,~          smartphone app based platform - for same day surgery postoperative follow up of patients~          receiving peripheral nerve blocks.~        -  Research Design Randomized open-label study, comparing the satisfaction of the two~          groups with the method of follow up, which is either over the phone or via a mCare~          application. A separate group made up of nurses and physicians will have the opportunity~          to take a short anonymous survey to rank their opinion on the use of the smartphone~          application for patient feedback.~   "
10379|NCT03430947|"~     This is a phase II, open label, non-randomised study of vemurafenib and cobimetinib after~     radiosurgery in adult patients with BRAFV600-mutant melanoma brain metastases. All patients~     will receive vemurafenib 960 mg twice a day on days 1 - 28 combined with cobimetinib 60 mg~     once a day on days 1 - 21 of each 28-day treatment cycle until disease progression, drug~     toxicity or death.~      The primary objective of this study is to determine the best overall response rate (BORR) in~     the brain. The extracranial BORR, intra- and extracranial duration of response,~     progression-free survival and overall survival, adverse events, quality of life and radiomics~     features predicting long-term local control of brain metastases and treatment-related~     toxicity will also be examined.~   "
10380|NCT03430934|"~     The objective of this study is to correlate traditional histological Mohs tissue mapping of a~     cutaneous tumor with the ICG-mapping procedure. The use of intradermal ICG in a cutaneous~     tumor during MMS followed by visualization using a fluorescent imaging system could allow~     surgeons to directly visualize, and roughly map the extent of a primary skin cancer and plan~     the Mohs procedure (i.e. the initial excision size and subsequent layer widths) accordingly.~   "
10381|NCT03430921|"~     The purpose of this pivotal investigation is to evaluate the efficacy and safety of the~     Cutera enlighten multi-wavelength 532 nm and 1064 nm Nd:YAG picosecond pulse duration laser~     and an investigational micro-lens array (MLA) handpiece attachment for improvement of~     moderate to severe acne scars.~   "
10382|NCT03430908|"~     This is a prospective, single-arm cohort, observational study to determine the incidence of~     gastric tube malposition during blind insertion by an anesthesia provider.~   "
10383|NCT03430895|"~     This study is being done test to test the safety and effectiveness of durvalumab combined~     with tremelimumab in patients who have a rare form of cancer of the urinary tract.~   "
10384|NCT03430882|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of TAK-228, carboplatin, and paclitaxel that can be given to patients with~     advanced cancer. The safety of the drug combination will also be studied.~      This is an investigational study. TAK-228 is not FDA approved or commercially available.~     TAK-228 is currently being used for research purposes only. Carboplatin and paclitaxel are~     both FDA approved and commercially available for the treatment of various cancers. The~     combination of carboplatin and paclitaxel is frequently used in clinical practice. The~     combination of these drugs with TAK-228 to treat advanced cancer is considered~     investigational.~      The study doctor can explain how the study drugs are designed to work.~      Up to 50 participants will take part in this study. All will be enrolled at MD Anderson.~   "
10385|NCT03430869|"~     Late-life depression has been frequently associated with cognitive impairment. Several~     meta-analyses consistently suggested that a history of depression approximately doubles an~     individual's risk for developing dementia later in life. Neurodegeneration may play an~     important component in late-life depression. The pathophysiology behind the link between~     late-life depression and the subsequent development of dementia largely remains unclear, and~     should be heterogeneous. This highlights the need to identify specific neurodegenerative~     pathways involved in late-life depression, which will facilitate research on mechanisms and~     new treatments in the future.~      The recently published the National Institute on Aging and the Alzheimer Association (NIA-AA)~     criteria might provide new insights and frameworks to explore the patterns of~     neurodegenerative process in elderly depressed patients and to categorize them into different~     biomarker-based groups. In the present project, the investigators will recruit 40 patients~     with lifetime major depressive disorder, and 20 non-depressed cognitively normal comparison~     subjects. Alzheimer's disease pathology (A) was determined by measuring Aβ deposition by F-18~     AV-45 PET, and neurodegeneration (N) was established by measuring hippocampal volume using~     MRI. Individuals were categorised as A-N-, A+N-, A+N+, or suspected non-Alzheimer's disease~     pathophysiology (A-N+, SNAP). All subjects will further undergo F-18-THK-5351 image study to~     detect underlying tau pathology. By doing this, the investigators will elucidate the~     neurodegenerative pathophysiology behind the link between depressive disorder and the~     subsequent development of dementia.~   "
10386|NCT03430856|"~     This is an open label Phase II/III study to evaluate the efficacy and safety of test drug,~     Insulin Tregopil (IN-105) compared with Insulin Aspart (IAsp) in Type 2 Diabetes Mellitus~     patients. on stable dose of Metformin and insulin Glargine. The study will be conducted in 2~     parts, Part I and Part II. The study duration will be approximately 37 weeks for Part I and~     for Part II of the study respectively~   "
10387|NCT03430843|"~     The purpose of this study is to evaluate the efficacy and safety of BGB-A317 as second line~     treatment in patients with advanced unresectable/metastatic ESCC that has progressed during~     or after first line therapy.~   "
10388|NCT03430830|"~     The purpose of this study is to evaluate the pharmacokinetics and safety of ASC16 after~     3-single dose(50mg、100mg、200mg) or fixed continuous dose(200mg) in healthy volunteers.~   "
10389|NCT03430817|"~     This randomized study aims at comparing between the effects of amantadine, citcholine and its~     combinations on arousal and behavioral consequences in early phase of moderate Traumatic~     Brain injury (TBI).~   "
10393|NCT03430765|"~     The proposed study will be a pilot randomized controlled trial comparing treatment as usual~     (TAU) to treatment as usual plus a brief Acceptance and Commitment Therapy (ACT) intervention~     (TAU + ACT) with mastectomy and lumpectomy patients identified as at-risk for developing~     persistent post-operative pain. The ACT intervention is a single individual therapy session~     scheduled two weeks following surgery. Potential participants will be recruited from the~     University of Iowa Breast Cancer Clinic. A sample size of n = 30 for each arm will be~     recruited. An attrition rate of 20% is anticipated so the total N to be recruited for the~     study is 72 participants. Study measures will consist of self-report questionnaires and~     medical record data. Data will be collected prior to surgery, one-week after surgery, and 3~     months after surgery.~   "
10394|NCT03430752|"~     The aim of the study is to examine the impact of cancer and treatment-related effects on the~     physical and psychosocial well-being and quality of life among Hong Kong Chinese survivors of~     childhood solid tumors.~   "
10395|NCT03430739|"~     Investigating the optimal usage time of helmet therapy is the aim of the study. Participants~     will be babies with deformational plagiocephaly. Plagiocephalometric assesments will be~     utilize to follow improvement of head symmetry. Scales asking sensational integration and~     severity of plagiocephaly will also be used. Time of daily usage will be follow with daily~     asking the caregivers how long the baby wear the helmet in a day. Participants will follow~     for three months.~   "
10396|NCT03430726|"~     In adults, probiotics have been shown to have no effect on the microbial composition and the~     beneficial effects are only transient. However, the gut microbiota of young children is less~     stable and more impressionable. The aim of this study is to examine the effects of probiotics~     on the developing microbiota in early life and to determine whether a young child's~     microbiota may be less resilient to probiotic-induced changes and possibly resulting in~     longer lasting probiotic effects compared to adults.~   "
10397|NCT03430713|"~     Twenty patients of Dental Medicine School will be recruited to participate in a pilot study~     about dental color measurement in which visual and digital instruments will be tested.~      Informed consents and local ethical committee clearance will be previously obtained.~      All data will be collected after an oral hygiene procedure. Two different methods of color~     measurement will be tested: visual method with VITA Classical (VC) and VITA 3D-Master (VM)~     and digital method with Spectroshade Micro (SS) and VITA Easyshade (ES). The CIE L*a*b*~     values will be evaluated in the VC scale for both methods. Reproducibility will be assessed~     based on intra-operator intra-device agreement and the accuracy will be assessed based on~     inter-device agreement using the kappa coefficient (K) and intraclass correlation coefficient~     (ICC), respectively. Results will be presented as mean, with 95% CI~   "
10398|NCT03430700|"~     The overall aim of the study is to demonstrate a clinically meaningful extension of~     progression free survival using maintenance pembrolizumab. The aim of the translational~     research is to study the immune microenvironment before and during pembrolizumab therapy.~   "
10399|NCT03430687|"~     This phase I trial studies the side effects and best dose of talimogene laherparepvec and to~     see how well it works in treating patients with non-muscle invasive bladder transitional cell~     carcinoma. Biological therapies, such as talimogene laherparepvec, use substances made from~     living organisms that may attack specific tumor cells and stop them from growing or kill~     them.~   "
10400|NCT03430674|"~     The purpose of this study is to better understand whether or not children with ALL can~     complete an exercise program during treatment and whether or not that program may impact~     peripheral neuropathy. Researchers will also study changes in the blood and body that may~     occur during the program by collecting samples of blood at various times during the study.~      Aim 1: Evaluate the feasibility and acceptability of EX as an intervention for VIPN in~     pediatric patients with ALL.~      Aim 2: Estimate preliminary effect sizes of the EX intervention.~   "
10401|NCT03430661|"~     The primary objective of this study is to assess the pharmacodynamic (PD) effects of~     clopidogrel and prasugrel when administered after a single subcutaneous (s.c.) dose of~     ACT-246475 in healthy male and female subjects~   "
10402|NCT03430648|"~     This project will provide new data to address an important question linking Alzheimer's~     disease neuropathology to physical disability.~   "
10403|NCT03430635|"~     ¹¹C-choline positron emission tomography/computed tomography (PET/CT) has been used in~     patients with some types of solid cancers, but few data are available in patients undergoing~     hepatectomy for hepatocellular carcinoma (HCC). The aim of this study was to analyze the~     prognostic value of metabolic imaging data by using ¹¹C-choline PET/CT in patients with HCC~     before hepatectomy.~   "
10404|NCT03430622|"~     To evaluate the effectiveness of a telephone based LTP Plus intervention for maternal~     depression.~   "
10405|NCT03430609|"~     Background: Endometriosis is defined by the presence of endometrial tissue outside the~     uterine cavity due to causes not yet fully elucidated. The disease affects approximately 2%~     of women of reproductive age and is associated with infertility. Approximately 17% to 44% of~     women with endometriosis exhibit endometrioma, or ovarian endometriosis. Laparoscopic~     cystectomy is currently considered the gold standard treatment for this problem, resulting in~     improvement of symptoms, a lower recurrence rate and a higher pregnancy rate among infertile~     patients. However, several studies have shown that this treatment is not free from risks~     because it is associated with reduction of the ovarian reserve due to accidental removal of~     ovarian cortex during stripping of the capsule or damage caused by the coagulation energy~     during hemostasis, even when performed by experienced surgeons. There is still controversy in~     the literature as to the cause of the reduction of the ovarian reserve, as the mere presence~     of endometrioma reduces ovarian function by itself. The aim of this study is to compare the~     effects of different hemostatic methods on the ovarian function of women subjected to~     laparoscopic surgery for ovarian endometrioma.~      Methods: Open-label randomized clinical trial to be conducted at Lauro Wanderley University~     Hospital from September 2017 to August 2020. Eighty-four patients will be randomly allocated~     to three groups according to the hemostatic technique used during laparoscopic surgery for~     ovarian endometrioma: bipolar coagulation, laparoscopic suture and hemostatic matrix. Ovarian~     function will be assessed by measuring serum anti-Mullerian hormone and follicle-stimulating~     hormone levels and by ultrasound antral follicle counts before surgery and 1, 3 and 6 months~     after surgery. The study was approved by the research ethics committee at the Medical~     Sciences Center, Federal University of Paraíba CAAE no. 71621717.9.0000.8069.~      Discussion: The present study intends to assess the ovarian function of patients with~     endometrioma subjected to laparoscopic surgical treatment, comparing different hemostatic~     techniques like bipolar coagulation versus suture versus hemostatic matrix with objective~     assessments of bipolar coagulation to avoid bias. Thus, the investigators expect to~     contribute data likely to dispel doubts on the subject.~   "
10414|NCT03430492|"~     This study aims to define the association between psychological resilience and biomolecular~     signatures in cancer patients and to relate psychological resilience to prognosis, as this~     could potentially open up a novel avenue of therapeutic interventions, medical as well as~     psychosocial.~   "
10406|NCT03430596|"~     This study is a pilot phased interventional clinical trial . The first stage will recruit 10~     patients with antipsychotic induced extrapyramidal symptoms.The patients will take~     pramipexole for 8 weeks. The inital dose of pramipexole will be 0.375 mg/d, and the~     adjustment of drug dose will be depended on the the doctor's decision and patients'~     condition.~      The second stage was a randomized, rater blindness and Antan controlled clinical study.~     Researchers will recruit another 40 patients with extrapyramidal symptoms (tradive dyskinesia~     will be excluded). The patients will randomly be divided into artane group or pramipexole~     group, and the efficacy and safety condition of pramipexole and artane for different kinds of~     EPS will be compared. The pramipexole group will have 20 cases, and 20 cases of artane group.~     The dose of pramipexole group group range from 0.375mg/d to 0.75mg/d dose .The dose of artane~     range from 2 mg/d to 4 mg/d,.The accurate drug doses can be adjusted by the doctor according~     to the patients' condition .~      Researchers will evualate patients' symptom at baseline, after three days' of baseline, 2~     weeks,4 weeks, 6 weeks and 8 weeks. The Simpson-Angus Scale(SAS) 、Barnes Akathisia Rating~     Scale（BARS）,Abnormal Involuntary Movement Scale (AIMS), Positive and Negative Syndrome~     Scale(PANSS), Calgary Depression Scale for Schizophrenia(CDSS), Clinical Global~     Impression-severity of Illness Scale(CGI-S) will be evualated by the trained raters indicated~     as the drug's efficacy of the extrapyramidal symptoms and schizophrenia .The adverse events,~     laboratory parameters, vital signs, ECG will be recorded as the safety indicators of the~     study drugs.~   "
10407|NCT03430583|"~     A study to evaluate the efficacy of MZ101 therapy in reducing liver stiffness.~   "
10408|NCT03430570|"~     This study will take a group-based intervention for adolescents that reduced sexual risk~     behavior and create a computer-based version, which is a format that adolescents like and~     that is more cost-effective. The intervention focuses on teaching adolescents skills for~     managing their emotions when they are making decisions that could put them at risk (like~     whether to have sex or drink alcohol). The investigators are hoping to learn whether a~     computer version of the program will be useful in helping adolescents learn about emotional~     competence and reducing risky behaviors. The investigators will make a version of the~     intervention as games on tablet computers in a partnership with a technology company, Klein~     Buendel. The research team will begin by getting advice from adolescents and experts (in~     separate groups) about how to convey the ideas from the group program into computer games.~     Klein Buendel will then create the games. Then, about 10 adolescents will be asked to try out~     the program and give us feedback about things to change. Klein Buendel will make those~     changes. Then the investigators will ask about 100 adolescents to volunteer to be randomly~     placed in one of two groups. One group will do the computer program right away; the other~     will wait for three months. Both groups will be asked to answer questions and do computer~     tasks when the team meets them, one month later, and three months later. The investigators~     will compare the groups to see if the group that received the computer intervention reports~     being more emotionally competent than the group that has not yet done the computer~     intervention. The research team will also ask them about their risk behaviors. If this is~     useful, it may be a good way to enhance health education taught in schools.~   "
10409|NCT03430557|"~     Title : Evaluation of the efficacy of Platelet Rich Plasma (PRP) in healing of through and~     through lesions~      Rationale: Bone replacement analogues have been used in the healing after periapical surgery.~     It has been a controversial issue to use bone grafts due to varied outcomes of different~     studies showing both improved outcomes and no difference. Lacunae while using bone grafts is~     their radiopacity which compounds the radiographic incomplete or uncertain healing. Thence we~     will be using platelet rich plasma as bone filling material.~      Aims and Objectives : To evaluate outcome of platelet rich plasma in healing after periapical~     surgery for through an through lesions.~      Setting: Department of Conservative Dentistry and Endodontics, PGIDS, Rohtak, Haryana.~      Study Design: Randomized controlled trial~      Time frame: 12-18 months~      Population/participant : Patients of age 16-45 years (male/female) will be enrolled in the~     study with diagnosis of through and through lesions.~      Inclusion criteria:- Patients of age 16 -45 years, -ve response to sensibility test, failed~     previous rct with purulent discharge, recurrent episode of purulent discharge.~      Exclusion Criteria:- Unrestorable tooth, fractured /perforated roots, serious medical~     illness, smokers, pregnant females and lactating mothers, grade 3 mobile teeth, the need for~     antibiotic prophylaxis prior to dental care.~      Sample size - a sample size of 30 patients has been calculated with n=15 in each group.~      Methods- Clinically and radiographically diagnosis of lesion, sensibility test by heat, cold,~     EPT, preoperative evaluation by bleeding on probing, clinical attachment level, gingival~     marginal position & pocket depth. Surgical procedures will be carried out under operating~     microscope with 8 × 16 magnification by following standardized treatment methods.~      Outcome Measures- The primary outcome variables observed for the study will be 3,6,9,12~     months clinical and radiographic success rates in terms of resolution of periapical~     radiolucency using the same criteria as preoperatively on the radiograph and alleviation of~     clinical sign and symptoms.~      Statistical Analysis : Intergroup and intra group comparison will be done according to~     distribution of data. Categorical data will be analyzed using chi-square test. Regression~     analysis will be done to observe any association between dependent and independent variables.~   "
10410|NCT03430544|"~     This is a phase II, randomized, single-blind, placebo-controlled study to examine whether~     cariprazine (1.5 or 3 mg/d) 1) alters brain and/or behavioral responses to probes of reward~     and inhibition and 2) decreases cocaine use in individuals with cocaine use disorder.~     Subjects will be tested as inpatients during fMRI and behavioral task sessions. Study~     medication will continue for 8 outpatient weeks, during which time cocaine use will be~     tracked. Subjects will be monitored during a 4-wk followup phase thereafter.~   "
10411|NCT03430531|"~     The objective of the study is to determine the effectiveness of Spheno-Palatine (SP) ganglion~     block to alleviate the pain of post-dural puncture headache (PDPH).~   "
10412|NCT03430518|"~     This study will evaluate the recommended Phase 2 combination dose (RP2D) of eribulin with~     durvalumab.~   "
10413|NCT03430505|"~     Asthma is a chronic inflammatory disease characterized by recurrent and reversible episodes~     of airway obstruction. Drug treatment usually includes inhaled corticosteroids and bronchial~     dilators, which often do not have adequate adherence. These acute episodes of~     bronchoconstriction can most often occur with hyperinflation and for decades the mechanisms~     that lead to hyperinflation have been studied, as well as increasingly modern ways of~     evaluating and treating these mechanisms. Noninvasive ventilation is increasingly occupying~     its space as a non-pharmacological resource in the treatment of asthma, initially as an~     adjunct in an attempt to help medication have its effect reached in the crisis, but this~     feature has been showing signs of having an even greater action which can even collaborate in~     reversing the crisis by not only giving time for pharmacological action. Recognizing these~     potential effects of this widely used resource and understanding its action on lung function~     and the reversal of exacerbation is part of this scientific process.~   "
10415|NCT03430479|"~     The aim of this study is to evaluate the safety and efficacy of anti PD-1 antibody with~     radiation therapy in patients with HER2-negative metastatic breast cancer.~   "
10418|NCT03430440|"~     Epidural PCA (patient controlled analgesia) for post-operative pain management are effective~     analgesic method. It is widely used in the postoperative pain management for decades.~      PCA pumps typically set a fixed basal infusion rate to infuse the analgesics at a constant~     rate per every hour (conventional mode). In contrast, the newly developed computer-integrated~     patient-controlled analgesia (CIPCA) mode increases or decreases the basal infusion rate with~     the use of the patient's bolus button. The CIPCA mode sets the basal infusion rate, the~     increase / decrease rate of basal rate, and the increment / decrement interval. If the~     patient presses the bolus button within the set time interval, the set infusion rate is~     increased because the analgesic is more required. If the bolus button is not pressed during~     the set time interval, the infusion rate is decreased. Therefore, it can be said that it is~     an effective method to control the dose of analgesic agent more sensitively to changes in~     patient's needs and pain.~   "
10419|NCT03430427|"~     Rapidly accumulating evidence indicates that the central nervous system (CNS) plays a pivotal~     role in mobility function with age-associated CNS changes strongly contributing to declining~     mobility. Studies linking the brain to mobility have used anatomical measures like brain~     volume and white matter integrity, and suggest that damage to the connecting fibers of the~     brain (white matter) is related to mobility impairment. Unfortunately, age-related structural~     white matter damage appears irreversible and only indirectly indicates the functional~     connectivity between brain regions. It is believed that functional brain network analyses~     have the potential to identify individuals that may benefit from interventions prior to the~     development of irreversible white matter lesions. The current project will assess both~     physical and cognitive function and integrate these variables with measures of brain network~     connectivity.~   "
10420|NCT03430414|"~     In adult kidney transplant recipients a therapy-responder and non-responder phenotype by~     antibody mediated rejection will be precisely defined according to clinical and histological~     characteristics such as creatinine, proteinuria and Banff-classification. Twenty-five~     patients will be selected each in the therapy-responder and non-responder group. Their stored~     Formalin Fixed Paraffin Embedded (FFPE) biopsies will be (re)-classified according to the~     most recent Banff classification. Using Nanostring Technology the gene transcription of~     therapy-responders versus non-responders will be analyzed and compared to serological and~     clinical parameters.~   "
10421|NCT03430401|"~     This study will adopt a newly developed computer-based cognitive rehabilitation program~     targeting the encoding stage of memory. The aims of the study are:~        1. To test the feasibility of conducting a newly developed computer-based cognitive~          rehabilitation program for people with MCI and mild dementia.~        2. To test the effectiveness of the newly developed program in improving cognitive function~          and enabling maintenance of occupational performance in people with MCI or mild~          dementia.~      Using an iPad application, study participants will learn a memory encoding strategy to~     support completion of their daily activities. By implementing memory encoding strategies~     during the mild stages of cognitive decline, the project aims to prolong independence in~     functional performance. It is anticipated that adoption of the same memory strategies will~     enable maintain performance as they may experience ongoing cognitive decline.~   "
10422|NCT03430388|"~     According to World Health Organization (WHO), since December 2016, Brazil is showing a~     significant increase in cases of yellow fever in humans. In view of this, vaccination is~     suitable for residents and travelers to the risk area. However, for immunosuppressed patients~     there is a formal recommendation not to vaccinate with live virus vaccine. On the other hand,~     the safety and efficacy of the vaccine has been demonstrated in patients with HIV, and safety~     and seroconversion have also been demonstrated in patients with rheumatic disease who were~     inadvertently revaccinated for yellow fever. Faced with the impossibility of leaving the~     high-risk area for some patients the vaccination could be released to only those who have low~     level of immunosuppression as suggested by some recommendations of medical societies. The~     availability of a fractional vaccine in the State of São Paulo, which has proved its~     efficacy, opens the possibility of exposure to a lower number of copies of the virus in the~     first exposure of immunosuppressed patients, allowing, if necessary, a safer revaccination,~     after 28 days to obtain of a more effective immunogenic response. The objectives of the study~     are to evaluate the immune response of the immunization with fractional yellow fever vaccine~     (neutralizing antibodies) in patients with systemic autoimmune rheumatic diseases residing in~     a high-risk area. Secondarily, evaluate the possible association between immunogenicity and~     vaccination with: demographic data, clinical and laboratory activity of the disease in~     patients with chronic rheumatic diseases, evaluate the curve of viremia and report adverse~     events. Patients and healthy controls will be vaccinated for yellow fever in the Immunization~     Center of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo~     (HC-FMUSP). The patients' screening for exclusion and inclusion criteria will be done at the~     rheumatology outpatient clinic after medical evaluation. For the controls will be the routine~     screening of the Immunization Center. The vaccination protocol will be a fractional dose of~     the yellow fever vaccine on day D0 for both groups. Patients will be evaluated on day D0, D5,~     D10, D30-4 and D365 and controls only on days D0, D10, D30-45 and D365 for aspartate~     aminotransferase (AST), alanine aminotransferase (ALT), platelets, urea and creatinine,~     immunoglobulin M (IgM) by immunofluorescence for Yellow Fever, viremia, autoantibodies.~   "
10423|NCT03430375|"~     Purpose: To examine the safety of the use of two wheelchair cushions for healthy individuals~     with intact sensation and individuals post stroke and spinal cord injury with impaired~     sensation. The new Ease Alternating Pressure wheelchair cushion will be compared to a static~     air cushion to examine interface pressure and skin responses in the areas of the buttock and~     posterior thighs when subjects sit without moving (static condition) and during upper~     extremity reaching activities (active condition). In addition, comfort, ease of transfer, and~     postural stability will be monitored while sitting on both cushions under both static and~     active conditions.~   "
10424|NCT03430362|"~     Women will be admitted when active phase of labour starts defined as the presence of at least~     three regular uterine contractions over 10 minutes with cervical dilatation four centimeters~     with cervical effacement not less than 50% and no progress of labor for 2 hours or more.~      Group A will receive injection Hyoscine butyl bromide 20 mg first dose at the time of~     amniotomy, and second dose 2 hours after. Group B, will receive normal saline same volume~     first dose at the time of amniotomy, and second dose 2 hours after.~      Labor will be monitored by Vaginal examination every two hours. The duration of the first~     stage was calculated from the time of cervical dilatation of three to four centimeters in~     active labor until a fully dilated cervix was observed.~   "
10425|NCT03430349|"~     This first-in-human (FIH) phase 1 study is designed to evaluate in contained conditions the~     safety, immunogenicity, shedding and genetic stability of both nOPV2 vaccine candidates in~     IPV-primed adults before testing in a larger adult and adolescent (> 15 y of age) population,~     and then in young children and infants. The primary objectives of the subsequent Phase 1 and~     2 studies will include the general safety, the shedding and genetic stability of the two~     candidate vaccines, primarily based on comparison with historical data obtained in the Phase~     4 studies of Sabin mOPV2.~   "
10427|NCT03430323|"~     The central hypothesis is that the combination of measurements from 3D optical scans with~     standard DXA scans can be used to calculate 4 unique body composition compartments: water,~     fat, protein, mineral. This is significant because it will allow for accurate assessment of~     adiposity and functional protein status independent of hydration. The hypothesis is based on~     preliminary data collected demonstrating the use of thickness and dual energy X-ray~     measurements to calculate three-compartment breast composition.~   "
10428|NCT03430310|"~     The hypothesis for this study is that pancreas lipid will be more closely associated with~     first-phase beta-cell response in African-Americans than in European-Americans, both at~     baseline and in response to treatment. The investigators will determine whether race~     influences the association of pancreas lipid with beta-cell function.The proposed research~     builds upon the investigators preliminary observations in non-diabetic adults that reduction~     in dietary glycemic load, in the absence of weight loss, selectively reduces visceral adipose~     tissue and ectopic lipid, and is associated with improvements in insulin sensitivity and~     beta-cell function. No study has attempted to test the hypothesis that selective reduction in~     pancreatic lipid with a simple change in diet composition, in the absence of energy~     restriction, will lead to the recovery of beta-cell function in patients with early Type 2~     Diabetes (T2D). The investigators hypothesize that participants following a Low Glycemic Diet~     will show a greater decrease in pancreas lipid. Specifically, the investigators will be the~     first to demonstrate that a weight-maintaining low-glycemic diet improves glucose tolerance~     by increasing first-phase insulin secretion. Results may be particularly relevant to~     African-Americans who are at greater risk for T2D.~   "
10429|NCT03430297|"~     This is one phase Ⅲ, randomized, open-label study in comparison of JS001 with dacarbazine as~     the 1st-line therapy for adult (≥18 years) subjects with unresectable or metastatic melanoma.~     The subjects will be 1:1 randomized and stratified in accordance with acral lentiginous~     melanoma and M stage (M0vsM1a/M1bvsM1c). Using standard dose and dose interval, the subjects~     will be given JS001 240mg intravenously, once every two weeks, or dacarbazine 1000mg/m2, d1,~     intravenously, once every three weeks. One cycle of therapy is 6 weeks (3 doses of JS001 or 2~     doses of dacarbazine per cycle).~   "
10430|NCT03430284|"~     The prevalence of diabetes mellitus has been increasing in recent decades in China, and~     vascular complication is the major burden in patients with type 2 diabetes. Previous studies~     demonstrated that only glycemic control was not effective enough to prevent or improve~     diabetic vascular complications, but guidelines from the Chinese Diabetes Society and other~     national guidelines recommend an integrated multifactorial treatment approach. In this study,~     we aim to evaluate the effect on diabetic vascular complications of a multifactorial~     intervention comprising behavior modification, polypharmacological therapy and periodical~     monitoring in patients with type 2 diabetes.~   "
10431|NCT03430271|"~     This study will be conducted to determine the safety and feasibility of translating a~     physical activity intervention (LIFE Study) into a community setting. Study outcomes include~     physical performance, safety, and feasibility of conducting the LIFE PA intervention in a~     community setting.~   "
10432|NCT03430258|"~     This prospective randomized controlled study was conducted in the emergency intensive care~     units (EICU) of the second affiliated hospital Zhejiang university school of medicine, a~     large tertiary university hospital in HangZhou, China.The aim of this randomized study was to~     compare the effectiveness of high-flow nasal cannula with conventional oxygen therapy in ICU~     patients with blunt thoracic injury.~   "
10433|NCT03430245|"~     Prospective, one-arm, baseline-controlled pilot study for the evaluation of the VelaShape III~     combined with UltraShape Power treatment for non-invasive circumference reduction to the~     thighs.~   "
10434|NCT03430232|"~     This is an interventional, first-in-man study, double-blind, placebo-controlled, two-part,~     ascending doses study to investigate the safety, tolerability and efficacy of STR-324~     infusions in healthy volunteers.~   "
10435|NCT03430219|"~     This is a prospective, multi-center, post-market data collection study intended to collect~     data on the short- and long-term safety and performance of the SCP Procedure.~   "
10436|NCT03430206|"~     THRIVE (Transnasal Humidified Rapid-Insufflation Ventilatory Exchange) refers to the use of~     high-flow nasal cannula to augment the ability to oxygenate and ventilate a patient under~     general anesthesia. The use of high-flow nasal cannula oxygen supplementation during~     anesthesia for surgical procedures has been a recent development in the adult population,~     with limited data analyzing the pediatric population. This study will determine whether high~     flow nasal cannula oxygen supplementation during surgical or endoscopic procedures can safely~     prevent desaturation events in children under anesthesia.~   "
10437|NCT03430193|"~     A number of studies for clinical pathway (CP) after hip fracture have been suggested to~     improve post-fracture outcome. However, CP is not carried out properly in most countries due~     to inadequate system and awareness, and lack of interdisciplinary approach among~     orthopaedists, geriatricians and rehabilitation specialists. Thus, we developed Fragility~     fracture integrated rehabilitation management (FIRM), a new standardized guideline and the~     multidisciplinary fragility fracture care based on the clinical rehabilitation pathway and~     conducted a prospective study to evaluate the effects of FIRM compared to conventional~     rehabilitation.~   "
10438|NCT03430180|"~     Primary objective:~      *To determine whether treatment with naloxone hydrochloride nasal spray reduces gambling urge~     symptoms in patients with gambling disorder~      The secondary objectives of the study are:~        -  To determine the effects of naloxone hydrochloride nasal spray on gambling severity,~          frequency and time, internet use, self-efficacy, quality of life, alcohol consumption,~          depression~        -  To evaluate the safety of naloxone hydrochloride nasal spray in the treatment of~          gambling disorder~   "
10439|NCT03430167|"~     The purpose of this study is to compare range of motion between a structured home exercise~     program to supervised physiotherapy post-operatively after Reverse Total Shoulder Replacement~     is performed for rotator cuff tear arthropathy/massive cuff tear through a single-center,~     assessor-blinded, randomized clinical trial.~   "
10543|NCT03428802|"~     This phase II trial studies how well pembrolizumab works in treating participants with cancer~     that has spread to other places in the body, has come back or has spread to nearby tissues or~     lymph nodes. Monoclonal antibodies such as, pembrolizumab, may interfere with the ability of~     tumor cells to grow and spread.~   "
10440|NCT03430154|"~     An online web-based cross-sectional survey in which participants will complete a distinct~     questionnaire for patients with hemophilia and obesity (PwHO) and/or their~     carers/spouses/partners, or a distinct questionnaire for healthcare professionals. Each~     questionnaire consists of more than 100 items including pre-coded (multiple choice)~     closed-ended questions, yes/no questions and rating scales. It is estimated that this one-off~     survey will take approximately 45-60 minutes to complete.~      As a cross-sectional study, there will be no treatment of patients.~   "
10441|NCT03430141|"~     The Nutritarian Women's Health Study (NWHS) is a long-term hybrid~     effectiveness-implementation study on the effect of the Nutritarian Diet on the occurrence,~     recurrence, and progression of chronic diseases (including all forms of cancer and~     cardiometabolic risk factors).~   "
10442|NCT03430128|"~     Patients with peritoneal disease commonly present with symptoms of abdominal distension and~     subacute intestinal obstruction. This results in poor oral intake leading to these patients~     often presenting in a malnourished state.~      CRS and HIPEC can potential provide improve survival for these patients, however can be a~     hazardous procedure, involving multi-organ resections. The risk is especially high in poorly~     nourished patients.~      The study investigators hypothesize that perioperative immunonutrition can reduce wound~     infections and length of hospital stay, and improve perioperative outcomes. To the~     investigators' knowledge, it has not been evaluated in patients undergoing CRS and HIPEC.~   "
10443|NCT03430115|"~     Aging is associated with significant declines in muscle mass, strength, and physical~     performance, all of which lead to disability, loss of independence, and adverse clinical~     outcomes. Obesity exacerbates these age-related declines in function and is associated with~     poorer clinical outcomes and quality of life. Weight loss can also worsen age-related loss of~     muscle mass and decrease bone mineral density. The overall goals of this study are to~     determine if the short-term functional benefits of intentional weight loss are sustained~     long-term, and to examine the long-term benefits and risks of weight loss.~   "
10444|NCT03430102|"~     The study is designed to repeat an initial training set study conducted at Johns Hopkins~     Medical Center, comparing a new investigational device, Indicor, a non-invasive tool for~     estimating left ventricular end diastolic pressure (LVEDP), to the gold standard, invasively~     measured LVEDP via direct measurement via left heart catheterization. The study is divided~     into an initial training set, followed by the validation set which is designed to support an~     FDA 510(k) submission and validate the final algorithm. Patients will be enrolled who are~     scheduled to undergo a cardiac catheterization and will be asked to perform three tests with~     the Indicor.~   "
10445|NCT03430089|"~     This phase I-like, open-label, monocenter, descriptive, single-arm clinical safety study will~     investigate the Shenzhen quadrivalent influenza vaccine (Shz QIV) in 100 participants aged 6~     months and older in China.~      Participants aged 9 years or more will receive a single dose of Shz QIV, and participants~     aged 6 months to 8 years will receive two doses of Shz QIV administered 28 days apart.~   "
10446|NCT03430076|"~     Open repair could be recommended in a first line of treatment to revascularize critical limb~     ischemia patients or performed in a second line of treatment in case of failure of~     endovascular repair. A good quality vein is one of the main factors that influence the~     clinical success of open revascularization for below-knee popliteal. In the absence of an~     suitable autologous vein, prosthesis such as polytetrafluoroethylen (PTFE) graft could be an~     option but demonstrated worse clinical and morphological results compared to autologous~     greater saphenous vein. Consequently, there is still a room for improvement in CLI patients~     in the absence of an suitable autologous vein in whom endovascular repair failed.~      Recently, PTFE with heparin-bound to the luminal surface (Hb-PTFE) significantly reduced the~     overall risk of primary graft failure by 37%, in particular, risk reduction was 50% in~     femoropopliteal bypass cases in cases with critical ischemia (58% Primary patency for crude~     ePTFE versus 80% primary patency for PROPATEN at 1 year follow-up) (Lindholt, et. al. 2011).~      Additionally, a weighted average from the literature suggests a 76% primary patency for below~     knee bypasses performed with PROPATEN at one year follow-up, whereas a published~     meta-analysis suggests a 59% primary patency for below knee crude ePTFE at one year~     follow-up. At two year follow-up using the same approach, the average primary patency for~     PROPATEN was 67% versus 43% for standard ePTFE.~      The aim of this study is to assess PTFE with heparin-bound to the luminal surface as an~     alternative to crude PTFE in absence of good venous conduit in patients with CLI.~   "
10447|NCT03430063|"~     The primary objective of the study is to compare the objective response rate(ORR) of high~     dose REGN2810 (HDREGN2810) and standard dose REGN2810 plus ipilimumab combination therapy~     (SDREGN2810/ipi) versus standard dose REGN2810 (SDREGN2810) in the second-line treatment of~     patients with advanced or metastatic squamous or non-squamous non-small cell lung cancer~     (NSCLC), in patients whose tumors express programmed cell death ligand 1 (PD-L1) in <50% of~     tumor cells.~   "
10448|NCT03430050|"~     Sex and gender differences in behavioral, biological, and clinical correlates of substance~     use disorders are myriad, yet there exists a dearth of gender-informed treatment options.~     Ovarian hormones have been identified as potential mechanisms of these disparities , and~     recent clinical trials have begun to examine their utility as possible pharmacotherapeutic~     agents. The ovarian hormone progesterone has shown promise as a treatment for female cocaine~     and nicotine users, but has not yet been tested for cannabis. Gender differences in cannabis~     withdrawal, which is associated with relapse, are pronounced and several studies report more~     severe and impairing withdrawal symptoms in women compared to men. Developing pharmacological~     interventions for cannabis withdrawal remains an important priority given the significant~     cognitive, psychiatric, and physical consequences of heavy cannabis use.~   "
10449|NCT03430037|"~     This is a pilot study to evaluate whether targeting inflammation will help reduce markers of~     insulin resistance inflammation, bone resorption and physical dysfunction in elderly women~     with gait disturbance. Positive results of this study would lead to the development of a~     larger clinical trial examining the effects of this intervention on age-related dysfunction.~   "
10553|NCT03428672|"~     RATIONALE: Collecting and storing bone samples from patients with osteoporotic and~     nonosteoporotic fracture to quantitatively analyze the differentially expressed proteins to~     further explain the relationship between bone iron content and bone mineral density (BMD).~      PURPOSE: This research study is looking at changes of iron content and differentially~     expressed proteins in bone samples from patients with osteoporotic and nonosteoporotic.~      fracture.~   "
10450|NCT03430024|"~     Gene expression, the transfer of the genetic code into cellular proteins is one of the most~     fundamental processes in living cells. This process is orchestrated by protein-based~     molecular machines, called RNA polymerases that read the DNA sequence to generate messenger~     RNA (mRNA), which is translated by the cellular machinery to make proteins. Our cells have~     evolved elaborate regulation mechanisms to control these molecular machines and a breakdown~     in this regulation leads to diseases such as cancer.~      Recently, molecules called myosins have been discovered in the genetic storage compartment of~     the cell (the nucleus) where they interact with RNA polymerases to regulate protein~     production. This is interesting because myosins are usually found outside the nucleus~     transporting cellular cargo or generating muscle contraction. In breast cancer cells, myosin~     is abundant and interacts with the oestrogen receptor. The majority of breast cancer in the~     UK is oestrogen receptor positive and activation of this receptor is an important factor~     controlling the growth of cancer cells. Oestrogen receptor activation appears to be dependent~     upon myosin and this research project will investigate how myosins are targeted to specific~     genes and how they are themselves regulated. This will greatly enhance our understanding of~     the role of nuclear myosins in oestrogen receptor positive breast cancer and may identify a~     novel therapeutic target for future drug development.~   "
10451|NCT03430011|"~     This is an open-label, multicenter, Phase 1/2 study to determine the safety and efficacy of~     JCARH125, a CAR T-cell product that targets B-cell maturation antigen (BCMA), in adult~     subjects with relapsed or refractory multiple myeloma. The study will include a Phase 1 part~     to determine the recommended dose of JCARH125 in subjects with relapsed or refractory~     multiple myeloma, followed by a Phase 2 part to further evaluate the safety and efficacy of~     JCARH125 at the recommended dose.~   "
10452|NCT03429998|"~     An open-label, prospective phase III study to compare the efficacy and safety of~     administering evolocumab versus treatment with LDLapheresis in patients with familial~     hypercholesterolemia and high cardiovascular risk.~   "
10453|NCT03429985|"~     While existing teen pregnancy prevention efforts have contributed to significant declines in~     the overall U.S. teen pregnancy rate, teen pregnancy prevention programs specifically~     targeting adolescent males are limited and sorely needed. The primary aim of the proposed~     research is to further develop, evaluate, and disseminate a teen pregnancy prevention program~     specifically designed for adolescent males to enhance the current scientific evidence and~     intervention options available for broad public health implementation. The proposed~     intervention Fathers Raising Responsible Men (FRRM) focuses on the adolescent male component~     of teen pregnancy by identifying and addressing adolescent risk and paternal protective~     behaviors specific to adolescent males that have not been fully addressed in previous~     prevention efforts. This study strives to reduce adolescent male sexual risk behavior through~     targeting African American and Latino adolescent males aged 15-19 and their fathers residing~     in the South Bronx, specifically Mott Haven and surrounding areas in three phases. Phase I is~     a pilot study consisting of eight dyads (fathers and sons) to test and refine the~     intervention and technical and training assistance needs. Phase II is the Randomized Control~     Trial (RCT) comprised of 500 dyads to rigorously evaluate the intervention. Finally, in Phase~     III the intervention will be refined and the intervention materials will be available to the~     general public, while findings will be widely disseminated. These three phases allow for the~     successful implementation and evaluation of FRRM in conjunction with the refinement and~     provision of all training and technical assistance necessary for the intervention. If~     successful, the proposed project will further develop the current scientific evidence and~     intervention options targeted specifically to the teen pregnancy prevention needs of African~     American and Latino adolescent males.~   "
10454|NCT03429972|"~     The trial will be preceded by a pilot phase study in 5 patients.~      This will then be followed by the randomized 1:1 phase II trial testing the utility of~     regional cryotherapy in preventing or reducing paclitaxel-induced peripheral neuropathy~     compared to no treatment.~      It is hypothesized that cryotherapy causes regional blood vessel constriction and decreases~     the paclitaxel exposure to the distal epithelial nerve fibres, thus resulting in decreased~     nerve damage.~   "
10455|NCT03429959|"~     The investigators aim to evaluate the user friendliness of a newly designed leg compression~     stocking kit, the SOCKNLEG, compared to a standard leg compression stocking of the same~     compression strength, the SIGVARIS Cotton. The SOCKNLEG is not yet commercially available,~     whereas the SIGVARIS Cotton has been successfully commercialized for many years.~      After an initial screening visit, a computer generated list will allocate the participants in~     either the SOCKNLEG or the SIGVARIS Cotton group.~      All participants will try on both study stockings, in the order of their allocated group, and~     will rate their donning and doffing success with a questionnaire. The patients will then wear~     only the assigned study stocking of their allocated group, for a day and rate its comfort~     again at the end of the day. The donning and doffing success will also be rated by the study~     investigator. Leg volume measurements of the study leg will be taken at each visit to~     determine edema prevention.~   "
10456|NCT03429946|"~     This study tests the hypothesis that, compared to prior normal blood sugar, prior low blood~     sugar impairs cardiovascular autonomic function. The proposed studies will also test the~     hypothesis that the effects of prior low blood sugar on cardiovascular autonomic function are~     blocked by administration of a mineralocorticoid receptor antagonist.~   "
10457|NCT03429933|"~     The purpose of this study is to investigate experimental medication BMS-986278 given to~     healthy participants.~   "
10458|NCT03429920|"~     This research study will test the effects of Q CAN PLUS powder on serum lipids, selected~     inflammatory and oxidative parameters and genome-wide methylation~   "
10459|NCT03429907|"~     The goal of this research study is to learn if starting a stress-reduction program before~     treatment can affect your stress, mood, and physical symptoms during and after treatment for~     cancer.~      This is an investigational study.~      Up to 140 participants will be enrolled in this study. All participants will be recruited at~     MD Anderson.~   "
10460|NCT03429894|"~     The DynamX stent study is a consecutive enrolling, prospective, multicenter clinical trial~     recruiting up to 50 patients at up to 10 international sites.~      Patients that require treatment of a single de novo lesion equal to or less than 14mm in~     length located in a coronary artery >2.5 mm and < 3.5 mm in diameter and meet all eligibility~     criteria will be invited to participate.~      After the stent implantation patients will be followed up clinically at 30 days, 180 days and~     annually for 3 years All patients will have an imaging follow up at either 6 months or 9~     months~   "
10494|NCT03429452|"~     The SALMANTICOR study will obtain data on the prevalence and incidence of structural heart~     disease in a population setting. A cross-section survey of randomly selected residents of~     Salamanca (Spain) will be performed. A total of approximately 2400 individuals, stratifies by~     place of residence (rural and urban) and by age and sex will be studied. The variables to~     analyzed will be obtained from the clinical history, different surveys including social~     status, Mediterranean diet, functional capacity, electrocardiogram, echocardiogram and~     biochemical and genetic analysis. Surviving participants are expected to return for a 5 and~     10-year follow-up visit.~   "
10461|NCT03429881|"~     Study objective: To evaluate serial generation of microparticles (MPs) after laparoscopic~     stripping or CO2 laser vaporization in surgical treatment of patients with ovarian~     endometrioma (OE).~      Design: A prospective, randomized, blinded, pilot study, including 33 patients. Setting:~     Tertiary university hospital from April 2015 to June 2017. Patients: 33 women with unilateral~     OE undergoing laparoscopic surgery. Intervention: Patients were randomly selected to undergo~     either CO2 laser vaporization (L group) or laparoscopic stripping (S group) of OE.~      Measurements and Main results: Blood samples were collected before surgery, and at 2 hours,~     24 hours, 1 month, and 3 months after surgery. MPs generation curve after ovarian~     endometrioma surgery was performed.~   "
10462|NCT03429868|"~     Nasopharyngeal carcinoma (NPC) differs from other head and neck malignancies terms of its~     epidemiology, pathology, and treatment outcome. Integrated PET/MRI is a new imaging modality,~     which can simultaneous acquire PET and MRI images. Considering lack of reports in the use of~     hybrid PET/MRI system in the prognosis prediction in NPC, we conduct this prospective study~     to investigate on the roles of integrated PET/MRI parameters for predicting treatment outcome~     and prognosis in patients with NPC.~   "
10463|NCT03429855|"~     In stroke patients, the impairment of the trunk affects many functions negatively. For this~     reason\ training of the trunk is necessary in the early period. Taking into account of~     literature, various approaches have been used to improve sitting balance and trunk control~     such as conventional physiotherapy for stroke patients . Bobath concept is another method~     used for stroke rehabilitation. When the studies about stroke rehabilitation are~     investigated, it is seen that most of the studies included only chronic patients and Bobath~     concept did not adequately take place in literature about trunk training. The aim of this~     study is to determinate effectiveness of the Bobath based trunk training on trunk control in~     acute stroke patients.~   "
10464|NCT03429842|"~     This study will be one of the first to systematically evaluate strategies to improve the~     implementation of a T&T strategy in a concentrated epidemic in Asia.~      While large controlled randomized trials assessing the efficacy of T&T at the community level~     are underway, they are being run in the generalised epidemic settings of Africa with the~     population HIV prevalence above 15%. Findings on implementation of T&T strategy from such~     settings will not be readily applicable to concentrated epidemics. This study will run in~     parallel with the trials so that the key implementation data in concentrated epidemic~     settings are available in a timely fashion. Finally, the study aims to develop capacity in~     implementation research in Indonesia.~      In line with principles of implementation science, the components of the intervention package~     will be designed from extensive discussions with all stakeholders including affected~     communities. This will ensure that the intervention is acceptable, feasible and could be~     integrated in to larger policy framework beyond the study. Further, the study will utilize~     and explore the role of primary care centres (Puskesmas) in providing 'Test and Treat'~     services. The success of T&T strategy based on primary care model will be critical for the~     wider penetration of services to the key affected populations.~      It will generate key data on critical steps in the cascade of care and show how current~     prevention services might enhance the uptake of HIV testing and immediate treatment. The~     study will identify which programmatic areas, under current resources, need strengthening for~     a larger scale implementation of T&T for HIV treatment and prevention.~      This will be a prospective implementation research study assessing the impact of enhanced~     community based interventions, on the uptake of HIV treatment and retention in care among key~     populations as part of a T&T strategy in three urban settings in Indonesia. The enhanced~     package of interventions will be introduced in a series of steps over time.~      This phase 1- Pre-implementation of the enhanced intervention package (Year 1) Current~     standard practices for HIV treatment and care will be observed ('business as usual'),~     utilising a comprehensive data collection system at each participating site. In accordance~     with current national guidelines, all HIV positive participants will be offered immediate ART~     initiation after being diagnosed as HIV positive.~   "
10465|NCT03429829|"~     Clinical study to evaluate the efficiency of Flairesse fluoride varnish in improving dental~     health in South African school children.~   "
10466|NCT03429816|"~     Patients with locally advanced, resectable gastric or esophagogastric junction adenocarcinoma~     will receive a biopsy of the primary tumor, followed by standard-of care neoadjuvant systemic~     treatment; after neoadjuvant therapy tumor biopsies will be taken from different sites of the~     resection specimen.~        -  Organoid cultures of pre-treatment tumor biopsies will be established and exposed to the~          same chemotherapy as the corresponding patient; in vitro response to treatment will be~          correlated with the in vivo response of patients.~        -  Whole genome, methylome and RNA sequencing of tumors biopsies and organoids will be~          performed prior to as well as after systemic treatment.~   "
10467|NCT03429803|"~     This research study is studying a drug TAK-580 (MLN2480) as a possible treatment a low-grade~     glioma that has not responded to other treatments.~      The name of the study drug involved in this study is:~      • TAK-580 (MLN2480)~   "
10468|NCT03429790|"~     The purposes of this study are:~        1. To compare the difference of blood loss of the patients undergoing cesarean section~          between intraoperative blood recovery and allogeneic blood transfusion.~        2. To compare the safety of the two methods.~        3. To evaluate the medical cost and the overall cost of the two methods.~   "
10469|NCT03429777|"~     The purpose of this project is to validate a quick, easy-to-use and administer smartphone~     hearing-in-noise test. The Hearing-in-Noise Test (HINT) measures an individual's ability to~     hear speech in quiet and in noise. HINTs are traditionally done testing both ears together as~     binaural hearing ability is key in noisy settings and everyday, functional hearing.~      The app (called HearMe) can potentially be used to easily and quickly collect~     hearing-in-noise and speech-in-noise measurements. The smartphone app developed is a~     hearing-in-noise test that presents the subject with a series of stimuli consisting of a~     spoken three-digit sequence presented at a varying hearing-to-noise ratio. For each stimulus~     presentation, the user tap the three-digit sequence. The duration of the app is less than 3~     minutes. For this project the investigators will test at least 50 subjects with hearing loss~     and 50 control subjects between the ages of 18-80. The subjects will be invited to take the~     app. The approach for this pilot study is to characterize hearing-in-noise thresholds (also~     referred to as a speech-reception threshold) as measured by the app in both subject groups,~     and relate it to the phenotype of each group as a preliminary evaluation of the app as well~     as a preliminary validation against their routinely collected measurements of hearing~     function (pure-tone audiometry thresholds).~      The study will assess the validity of the test construct in measuring hearing-in-noise~     thresholds, and serve as a foundation for further iterative designs of the app and future~     validation and characterization studies. This study seeks to validate a developed smartphone~     HINT on an initial cohort of patients and controls. It is anticipated that patients with~     hearing loss will display higher signal-to-noise ratio thresholds (as measured by the iPhone~     app) compared to controls.~   "
10470|NCT03429764|"~     Comparative clinical evaluation of internal mattress sutures vs continuous independent sling~     sutures on interdental papilla height and periodontal healing in esthetic zone.~      To evaluate the effect of internal mattress suturing technique on interdental papilla height~     and periodontal healing after periodontal surgery in esthetic zone.~      To evaluate the effect of continuous independent sling suturing technique on interdental~     papilla height and periodontal healing after periodontal surgery in esthetic zone.~   "
10554|NCT03428659|"~     In subacute stroke patients, dynamic time series data of brain imaging and motor function~     measurement were obtained from 7 days to 6 months (total 9 times) after stroke onset~   "
10555|NCT03428646|"~     A long-term observational registry in patients with atopic dermatitis initiating treatment~     with DUPIXENT® (dupilumab)~   "
10471|NCT03429751|"~     Bedside lung ultrasound can detect pulmonary congestion by detecting the appearance of~     B-lines. Pulmonary edema may occur even without cardiomyopathy or heart failure, especially~     after excessive fluid administration. B-lines have been acknowledged as sonographic signs of~     pulmonary interstitial and alveolar edema in critical and emergency care. Limited scientific~     evidence on optimal intraoperative fluid management has resulted in large variations of~     administered fluid regimens in daily practice. The restricted perioperative intravenous fluid~     regimen reduces complications after elective surgeries, however other studies had shown that~     intraoperative liberal fluid administration improves postoperative organ functions and~     recovery and shortens hospital stay after elective surgeries.~   "
10472|NCT03429738|"~     Evaluation of the comparative bioavailability between two oral formulations containing~     ibuprofen 200 mg and pseudoephedrine 30 mg after a single dose in healthy subjects under~     fasting conditions.~   "
10473|NCT03429725|"~     An online survey is conducted on MTurk populations from India and USA. Participants were~     assigned either a condition with primes of individualism or one with primes of collectivism,~     before responding to a scale on culture and indicating details of their demographics.~   "
10474|NCT03429712|"~     Radiation dose reduction has been a primary driver of technology development in~     multi-detector computed tomography (MDCT). The optimization of radiation dose for patient and~     task specific computed tomography (CT) applications continues to be an ongoing challenge,~     especially in pediatric patients where the desire to reduce radiation dose to lowest possible~     levels leads to both positive and negative effects. A novel research tool on the Siemens dual~     source (Flash® and Force ®) CT scanners allows one to assess multiple tube current levels~     from a single CT acquisition without incurring additional dose to the patient. Tube current~     is a primary contributor to radiation dose and image noise, which are inversely related. This~     is achieved by independently adjusting the current of each tube, while maintaining same kV in~     each x-ray tube. Moreover, Duke's medical physics team has developed a method based on~     mathematical expressions that allows the creation of incremental dose levels from the~     acquired image data sets. This innovative and powerful tool can be used to compare diagnostic~     accuracy, detectability, and many more relevant clinical features amongst multiple tube~     current levels with the attainment of a single CT acquisition.~   "
10475|NCT03429699|"~     Interventions that encompass behavioral modifications of dietary intake and physical activity~     dietary management are essential for the management of obese children. This study assessed~     the effectiveness of a stage-based lifestyle modification intervention for obese children. A~     total of 50 obese children (7-11 years) were randomized to intervention (n=25) or control~     (n=25) group. Data were collected at baseline, at follow-up (every month) and at six-month~     post-intervention. The intervention group (IG) received stage-based lifestyle modification~     intervention based on Nutrition Practice Guideline for the Management of Childhood Obesity,~     while the control group (CG) received standard treatment. Changes in body composition,~     physical activity, and dietary intake were examined in both intervention and control groups.~   "
10476|NCT03429686|"~     The purpose of this study is to explore the feasibility and acceptability of a digital~     reminiscence therapy (DRT) intervention for people with dementia (PwD). The objectives of~     this study include:~        1. To determine whether DTR can be delivered as planned in the care of PwD in Jordanian~          care homes.~        2. To determine whether DTR is acceptable/tolerable to PwD and care home staff in Jordanian~          care homes~        3. To identify the most appropriate outcome measures to evaluate the delivery of DRT to PwD~          in Jordanian care homes to be used in a subsequent definitive trial.~   "
10477|NCT03429673|"~     The trial was designed to compare effectiveness and safety of surgeries in the patients with~     non-small cell lung cancer~   "
10478|NCT03429660|"~     Primary immune thrombocytopenia (ITP) is rare. First-line treatment is corticotherapy. Then,~     several second-line treatments (SLT) are available: splenectomy, off-label rituximab and~     thrombopoietin-receptor agonists since 2009. The compared efficacy and safety on clinical~     events in the long-term are unknown. The main objective of the FAITH study is to build the~     cohort of all treated adult persistent (≥3 months) primary ITP patients in France, to assess~     the benefit-to-risk ratio of SLT in real-life practice. Data source is the database of French~     Health Insurance System (SNIIRAM) which covers the entire French population. It collects~     demographic, chronic disease, hospitalization and drug dispensing data. All patients with ITP~     were extracted from 2009 to 2012, and then every year for 10 years. The investigator will~     build the cohort from raw data. Outcomes (death, hospitalization, drug dispensing) will be~     compared according to SLT, with controls from the general population and untreated patients.~   "
10479|NCT03429647|"~     Blood supply to the sigmoid colon during open abdominal aortic aneurysm (AAA) repair is at~     risk. Ischemia of the sigmoid colon after AAA repair is potentially devastative. No reliable~     measures to prevent it are available and the underlying mechanisms are poorly understood. The~     aim of this study is to describe intraoperative perfusion patterns of the sigmoid colon~     during open AAA repair and their potential impact on postoperative outcome.~   "
10480|NCT03429634|"~     To compare the immediate and long-term clinical outcomes between Balloon-Stent Kissing~     Technique (BSKT) and Jailed Wire Technique (JWT) for the interventional treatment of coronary~     bifurcation lesions.~   "
10481|NCT03429621|"~     Tubal ligation is an everyday procedure for permanent female sterilization. It is usually~     performed after a vaginal delivery. Minilaparotomy is generally performed by doing small~     incision at infraumbilical area. This minimal access surgery requires adequate operative~     field exposure. Bowel interference, which obscures visualization of the operative field has~     been recognized as one of the major obstacles during this procedure. We found problems while~     doing surgery in small space and one of them is bowel interferance which obscures vision.~     This could lead to prolonged operation and complications. Simethicone is an antifoaming agent~     that use in bowel preparation prior to various procedures including laparoscopy, colonoscopy,~     endoscopy, and open major abdominal operations. Simethicone is proven to break the bubble and~     reduce intraluminal gas. This effect could result in reduction of bowel dilatation that~     interfere with the proper identification of the adnexal area. Benefit of taking simethicone~     prior to do minilaparotomy for tubal resection has not been examined.~      Objectives: To examine the effect of simethicone on reducing bowel interference during~     minilaparotomy for tubal resection.~      Design: A randomized controlled trial in women, age 20-45 years, undergoing postpartum~     sterilization after vaginal delivery at Faculty of Medicine, Chiang Mai University hospital.~     The participants will be randomly assigned into one of two study groups: intervention (taking~     simethicone) and control (not taking simethicone). For the intervention group, each woman~     will take simethicone (80 mg) 2 tablet chewing with water 50 ml at 2-8 hours before surgery.~     Fasting at least 6 hours before surgery. For the control group, the women will receive the~     same standard perioperative care without taking simethicone. The primary outcome measure will~     be surgeon-rated operative difficulty score, which is a visual analog scale based on assess~     from exposure of to the operative field in visual analog scale by surgeon. The secondary~     outcome will be operative time and incidence of intraoperative and postoperative~     complications.~   "
10482|NCT03429608|"~     The study aims to assess for the first time, through the application of innovative~     technologies (micro-CT), important characteristics of aspirated thrombi (such as their volume~     and their density), which might be linked to certain clinical outcomes, in patients~     presenting with STEMI and referred for primary Percutaneous Coronary Intervention (PCI). To~     this end, a methodology for the exact estimation of thrombus burden by measuring the volume~     and the density of aspirated thrombi will be developed. After being aspirated using dedicated~     catheters, thrombi will be preserved in formalin and their volume and their density will be~     calculated with the use of micro-CT. Having a better resolution than conventional computed~     tomography, micro-CT will allow us to create 3D models of aspirated thrombi from a series of~     x-ray projection images. These 3D models will be further analyzed in order to find the volume~     and the density of aspirated thrombi. Shape analysis of the surface of aspirated thrombi and~     potential differences in their structure will also be assessed. Correlation of these~     variables with clinical parameters and angiographic outcomes will be attempted.~      Thus, a risk-stratification model will be developed combining:~        -  Clinical and laboratory data,~        -  Angiographic parameters,~        -  Data regarding the volume, the density and the composition of aspirated thrombi.~      This model will enable the stratification of the cardiovascular and cerebrovascular risk of~     patients and the identification of who will benefit from thrombus aspiration, providing a~     personalized approach in treating patients with STEMI.~   "
10483|NCT03429595|"~     This is a Phase 2 study evaluating the safety, tolerability, systemic exposure, and activity~     of topical ATx201 GEL (2% and 4%) treatment for 1, 2, or 5 days in outpatients with primary~     nonbullous or bullous impetigo.~   "
10484|NCT03429582|"~     The purpose of this academic-industrial partnership will be to compare two thermoablation~     modalities using devices adapted to low and middle income countries (LMICs) to traditional~     CO2-based cryotherapy for the treatment of cervical precancer. The investigators will~     investigate whether the cure rates of cervical intraepithelial neoplasia 2 and more severe~     diagnoses (CIN2+) with these devices are non-inferior compared to that of conventional~     cryotherapy. The results of this study will affect other research areas by serving as a~     springboard to exploring treatment alternatives that are amenable to low-resource settings~     and thus will reach the most vulnerable populations.~   "
10485|NCT03429569|"~     A monocentric, parallel-arm, prospective, randomized therapeutic trial that compares the~     efficacy of two curative keratoconus treatment techniques by cross-linking collagen~     (accelerated conventional technique or iontophoresis). The primary endpoint will be the depth~     of the demarcation line measured by confocal microscopy and OCT at 1 month. This line~     represents the limit depth between treated and untreated stroma.~   "
10486|NCT03429556|"~     To determine the safety and efficacy of single intra-operative treatment of EB-001 IM~     injections into the Rectus Abdominus (RA) in subjects undergoing abdominoplasty.~   "
10487|NCT03429543|"~     The purpose of this research study is to evaluate the efficacy and safety of an empagliflozin~     dosing regimen and one dose of linagliptin in patients with type 2 diabetes who are aged 10~     to below 18 years and are currently taking metformin, insulin or both drugs.~      Empagliflozin and linagliptin are both approved for use in adult patients with type 2~     diabetes. This study will assess how well empagliflozin and linagliptin work by finding out~     how these treatments affect blood glucose (sugar) levels compared to placebo (a pill that~     contains no active drug), in children and adolescents. Empagliflozin and linagliptin are~     considered investigational products in this study since while they have been approved for use~     in adults, they have not been approved for children and adolescents due to lack of clinical~     studies in this specific population.~      Patients with type 2 diabetes have higher levels of blood glucose (sugar) than patients who~     do not have this disease. The high level of sugar in the blood can lead to serious short-term~     and long-term medical problems. The main goal of treating diabetic patients is to lower blood~     glucose to a normal level. Lowering and controlling blood glucose help prevent or delay~     complications of diabetes such as heart disease, kidney, eye and nerve diseases, and the~     possibility of amputation.~      Empagliflozin is a drug that helps to reduce blood glucose (sugar) levels by causing glucose~     to be excreted in the urines.~      Linagliptin works by increasing the production of insulin (a hormone that controls the level~     of blood glucose) after meals when blood glucose (sugar) levels are too high. This helps to~     lower blood sugar levels.~      The subject will either receive one of the active study drugs or a placebo. This study will~     be double blind; this means that neither the subject, nor the study doctor will know which~     treatment the subject will receive.~      Which treatment the subject receives is decided by a computer, purely by chance; this is~     called a random assignment.~      For this study, there will first be a screening visit, followed by a 2-week placebo run-in~     period (all subjects will take placebo once daily). This run-in period is designed to ensure~     subjects are able to take the study drugs as described in the study protocol. Thereafter~     there will be a 26-week treatment phase (week 1-week 26) and a 26-week safety extension~     period (week 27-week 52). Following this there will be a follow-up visit at week 55.~      On Day 1 after the placebo run-in phase, the subject will be randomly assigned to receive one~     of the 3 treatments: empagliflozin 10 mg, linagliptin 5 mg or placebo in a blinded manner.~     This treatment will continue up to week 14. Then after week 14, the subject will be assigned~     to receive one of the following 4 treatments: empagliflozin 10 mg, empagliflozin 25 mg,~     linagliptin 5 mg or placebo in a blinded manner. The drugs assigned after week 14 will be the~     same drugs as on Day 1 but some subjects will receive a higher dose of empagliflozin.~      After the completion of the 26-week treatment period, the subject will enter a 26-week safety~     extension period. The same active treatment that the subject had been assigned to at week 14~     visit will be continued. Subjects assigned to placebo on Day 1 will be randomly assigned to~     receive one of the 3 active treatments: empagliflozin 10 mg, empagliflozin 25 mg or~     linagliptin 5 mg in a blinded manner. This safety extension period is primarily designed to~     provide additional information on how well empagliflozin and linagliptin are tolerated.~      Following the treatment phases, there will be a follow-up visit at week 55~      Intervention model description:~      Eligible subjects with HbA1c of 6.5% to 10.5% at screening will be randomized in a 1:1:1~     ratio to receive empagliflozin 10 mg, linagliptin 5 mg or placebo. HbA1c assessment will be~     performed at Week 12. All subjects with Week 12 HbA1c < 7% will remain on previously assigned~     randomized treatment. Subjects taking empagliflozin with Week 12 HbA1c >= 7% will be~     re-randomized in a 1:1 ratio to continue on the low dose treatment (empagliflozin 10 mg) or~     up-titrate to the high dose treatment (empagliflozin 25 mg). Subjects taking linagliptin or~     placebo with Week 12 HbA1c >= 7% will remain on previously assigned treatment. All subjects~     will get new medication kits dispensed at Week 14 to maintain the blinding.~      At Week 26, all subjects previously assigned to placebo will be re-randomized in a 1:1:1:~     ratio to receive one of the active treatments: empagliflozin 10 mg, empagliflozin 25 mg or~     linagliptin 5 mg. All subjects will get new medication kits dispensed at Week 14 to maintain~     the blinding.~   "
10488|NCT03429530|"~     The aim of this work is to study the role of circulating miRNAs in diagnosis of HCV related~     hepatocellular carcinoma.~   "
10489|NCT03429517|"~     Background Changes in high-density lipoprotein cholesterol and triglyceride levels have been~     linked to residual cardiovascular risk, whereas non-high density lipoprotein levels have been~     shown to be more predictive of cardiovascular risk than are low-density lipoprotein~     cholesterol levels. We aimed to investigate the impact of high density lipoproteins,~     triglyceride, and non-high density lipoproteins levels on acute coronary syndrome risk with~     on-target low density lipoproteins levels.~   "
10490|NCT03429504|"~     Obesity has been linked to an increased risk of developing a number of malignancies,~     including postmenopausal breast cancer. One of the established risk factors for breast cancer~     development in post-menopausal women is obesity which has further been linked to breast~     cancer recurrence and poorer survival in pre- and post-menopausal breast cancer.~   "
10491|NCT03429491|"~     This study will examine the effect of leucine-enriched protein supplementation, alone and in~     combination with long chain n-3 polyunsaturated fatty acids (LC n-3 PUFA), on muscle mass and~     function in older adults at risk of sarcopenia.~      We hypothesize that LC n-3 PUFA supplementation will further enhance the efficacy of the~     leucine-enriched protein.~   "
10492|NCT03429478|"~     Surgery induced sterile inflammation leaves behind a biomolecular footprint measurable by~     various pro-inflammatory markers e.g. IL-6, CD(Cluster of differentiation)19B,~     HsCRP(High-sensitivity CRP) etc. Music is a non-pharmacological means in attenuating this~     inflammatory pathway thereby improving Health related quality of life measurable by improved~     postoperative convalescence. Correct timing of music application is a lacuna in the~     knowledge. This research aims at evaluating the effect of preoperative music on sterile~     inflammation induced by index Laparoscopic Surgery (Laparoscopic Cholecystectomy) and its~     proposed beneficial effects on patient reported outcomes. A total of 50 patients divided into~     2 groups (test and control) will be evaluated in this triple blind randomized controlled~     study aiming at evaluating the biomolecular signatures of sterile inflammatory response and~     its correlation with improved postoperative convalescence. All the patients will be followed~     up for a period of 1 month postoperatively to assess for overall improvement in health~     related quality of life. Collected data will be analysed using updated SPSS software and a p~     value of less than 0.05 will be taken as statistically significant in support of the measured~     indices.~   "
10493|NCT03429465|"~     The aim of the study is to determine whether a neuroscience-inspired cognitive remediation~     video game (EVO) that targets the cognitive control network (CCN) will improve executive~     functioning (EF) and resilience to psychiatric symptoms in typically developing 6th grade~     students, unselected for specific psychiatric symptoms. The primary goals are to 1) determine~     if EVO will result in improved EF and lower internalizing (e.g., mood, anxiety) and~     externalizing (e.g., attention deficit/hyperactivity disorder, AD/HD) psychiatric symptoms,~     2) evaluate whether the benefit experienced by youth changes depending on their level of life~     stress (e.g., academic or social difficulties), 3) determine if EVO will promote resilience~     to stress. We will measure EF, symptoms, and stress using self- and parent-report~     questionnaires. Other secondary outcomes include information on behavior in the classroom and~     academic performance (i.e., grades) that we will collect via school records. We hypothesize~     that engagement with EVO 20-minutes per day, 5-days a week across 4-weeks will improve EF,~     lower psychiatric symptoms, improve academic/behavioral functioning at school, and decrease~     maladaptive responses to stress.~   "
10495|NCT03429439|"~     Chronic hepatitis B(CHB) is a common infectious disease affecting up to 2 billion people~     worldwide. Around 650 thousand people died of liver failure, cirrhosis and primary liver~     cancer caused by chronic hepatitis B every year. Age is the main factor affecting the~     chronicity of hepatitis B, while 90% and 25% to 30% of hepatitis b virus(HBV) infection in~     perinatal and infant period will develop into chronic infection respectively. Whereas the~     proportion in patients above 5 years old is only 5% to 10%. Intestinal microbiota plays an~     important role in maintaining normal physiological function of the intestine and the immune~     function of the body. It has been found that the disorder of intestinal microbiota is~     associated with numerous intestinal and parenteral diseases. Intestinal microbiota~     transplantation(IMT) is a significant method to reconstruct intestinal flora. Recently, the~     relationship between immune response and intestinal microbiota has been claimed. In a~     previous study using IMT to treat HBeAg positive chronic hepatitis B patients combined with~     antiviral therapy, 80% of them has reached HBeAg clearance. The investigators propose a~     randomised trial of IMT in patients with chronic hepatitis B combined with antiviral therapy.~     The investigators will assess the serum HBsAg, anti-HBs, HBeAg, anti-HBe, anti-hepatitis B~     core antigen, the relief of gastrointestinal symptoms, and the fecal microbiota before and~     after IMT. Patients will be randomized to either antiviral therapy or IMT combined antiviral~     therapy over a 26 weeks period.~   "
10496|NCT03429426|"~     Today, regular X-ray examination is not sufficiently sensitive for detecting progression of~     bone destruction in rheumatoid arthritis, but a new type of high-resolution CT scanner, the~     High-Resolution peripheral Quantitative Computed Tomography (HR-pQCT) can detect very early~     and minor joint injuries.~      The purpose of this study is to use HR-pQCT techniques to look at the damage and disease~     activity progression in the hand and wrist joints of patients with rheumatoid arthritis.~   "
10497|NCT03429413|"~     Human papillomavirus (HPV) vaccines have potential to prevent an average of 26,900 cancer~     cases each year in the United States, but vaccine coverage rates remain low. The study team~     has developed an electronic application (app), Protect Me 4, to help parents and providers~     assess and have more productive conversations about needed vaccines.~      The specific aims of this study are to: (1) evaluate the feasibility of implementing Protect~     Me 4, and (2) estimate preliminary efficacy of Protect Me 4 to increase HPV vaccine~     initiation (receipt of first dose).~   "
10498|NCT03429400|"~     This is a multicenter, open-label study to evaluate the safety and PK of oral morphine~     sulfate in pediatric subjects with post-operative pain.~   "
10499|NCT03429387|"~     Patients with acute leukaemia requiring induction or consolidation chemotherapy and those~     requiring a haematopoietic stem cell transplant are at high risk of fever and infection when~     they have low white cell counts (neutropenic fever). The causes of neutropenic fever are~     frequently unknown and patients are treated with broad antibiotics, without a clear target to~     what is being treated.~      This study will prospectively enroll patients who are receiving chemotherapy for acute~     leukaemia or for a stem cell transplant and compare the diagnostic utility of bacterial and~     fungal PCR performed directly off blood drawn, to the standard blood culture. Patients who~     have persistent fever after 72 hours of antibiotics will then be randomized to have either~     the interventional scan (PET/CT) or the conventional scan (standard CT) to look for a source~     of infection. Diagnostic yield, change in management and outcomes will be compared between~     arms.~   "
10500|NCT03429374|"~     In laparoscopic ventral hernia repair, an abundance of methods has been developed to fix the~     mesh to the abdominal wall, including sutures (non-absorbable or absorbable), staples~     (non-absorbable or absorbable), clips, tacks (non-absorbable or absorbable) and (fibrin and~     synthetic) glues. Which fixation technique is superior, is still under evaluation. There is~     clearly a need for larger trials to obtain confident results on the safety and performance of~     glue mesh fixation and tack mesh fixation in LVHR. The hypothesis of this prospective,~     randomized controlled study is that post-operative pain at 4 to 6 weeks after mesh fixation~     with glue (LiquiBand® Fix 8™) will not differ compared to treatment with absorbable tacks~     during LVHR. A total of 510 patients will be recruited for this trial. This study will~     assess: pain, hernia recurrence, safety, procedural characteristics, technical success,~     analgesic intake, period to return to normal activity and quality of life.~   "
10501|NCT03429361|"~     The purpose of this study is two-fold:~        1. To identify the best smartphone data features (based on keyboard, sensor, voice/speech~          data) that correlate with mood, anxiety, and cognitive assessments in patients with~          Major Depressive Disorder (MDD) and Bipolar Depression (BD).~        2. To identify the best smartphone data features (based on keyboard, sensor, voice/speech~          at a) that predict relapse and remission in MDD or BD.~   "
10502|NCT03429348|"~     Firefighters are at increased risk of cancer, and both inhalation and dermal routes~     contribute to overall exposure to carcinogens, including polycyclic aromatic hydrocarbons~     (PAHs). The purpose of the current study is to determine if post-fire firefighter~     rehabilitation in an infrared sauna: a) affects absorption of PAHs as measured by urinary~     metabolites; and b) changes core body temperature and heart rate.~   "
10503|NCT03429335|"~     The Just TRAC It! study (Transitioning Responsibly to Adult Care using smart phone~     technology) is a randomized controlled trial designed to evaluate the impact of using smart~     phone technology in combination with the nurse led transition intervention, versus the~     current standard of care (nurse led transition intervention including MyHealth Passport), on~     preparing adolescents with chronic cardiac disease to successfully transition from pediatric~     to adult cardiology care. Just TRAC it! is a mobile-health intervention designed to teach~     youth to manage their health using existing functions on their mobile devices. We propose to~     conduct a nurse-led intervention that encourages adolescents to use Just TRAC it! while~     addressing the healthcare transition needs of 16-18 year olds.~   "
10513|NCT03429205|"~     External warming is routinely used in general surgery to offset the deleterious effects of~     hypothermia. It entails deployment of a disposable, external heating blanket attached to a~     regulated hot-air pump.~      The need for external warming in the morbidly obese population undergoing short laparoscopic~     procedures is unclear. If proven to be unnecessary, time and momentary costs could be~     lowered.~      The study will compare core-temperature dynamics during laparoscopic bariatric procedures~     anticipated to last <2h. The study group will be left without a warming blanket while the~     control group will receive routine external warming. Post-anesthesia care unit (PACU) arrival~     temperature will also be recorded.~   "
10504|NCT03429322|"~     Mayo Clinic's Traumatic Brain Injury (TBI) Model System Center (TBIMSC) will capitalize on~     longstanding collaborations with the non-profit Minnesota Brain Injury Alliance (MN BIA) and~     Minnesota Department of Health (MDH) to test a new way of delivering medical and social~     services. This trial will address chronic unmet needs expressed by individuals with TBI and~     their families in the U.S. pertaining to the ineffective connection to specialized medical~     and community resources in the transition from hospital to community-based care, limited~     access to TBI experts, and lack of primary care provider (PCP) knowledge about the complex~     needs of individuals with TBI. Target populations for this study are: 1) individuals with TBI~     eligible for MN BIA provided Resource Facilitation (RF), 2) their families, and 3) their~     PCPs.~      This clinical trial will use a theory-driven complex behavioral intervention that integrates~     the medical-rehabilitation, therapy, and TBI expertise of Mayo's Brain Rehabilitation Clinic~     (BRC) with MN BIA's highly developed RF program (a free two-year telephone support service~     offering assistance in navigating life after brain injury). Mayo Clinic's~     medical-rehabilitation expertise will be integrated with RF services to deliver direct~     clinical care remotely using telemedicine and other information and communication technology~     to test whether outcomes over time are better in a group receiving this model of care~     compared to a group that receives usual care in their communities.~      Costs between usual care and intervention groups will be compared in collaboration with the~     MDH. The overarching goal is development of a replicable, sustainable, and cost effective~     model of telemedicine care that integrates TBIMS Centers and BIAs nationwide and builds TBI~     expertise and capacity among PCPs.~   "
10505|NCT03429309|"~     Telomeres are protein-bound DNA repeat structures at the end of eukaryotic chromosomes that~     are made up of a simple repetitive sequence (in humans, TTAGGG) and regulate cellular~     replicative capacity and cellular proliferation, protect chromosomes from fusing together~     during mitosis and maintain genomic stability, and prevent the loss of genetic data.~     Telomeres are specialized repetitive DNA sequences, typically ranging from 5,000 to 15,000 bp~     in humans, which are the critical chromosome capping DNA sequences. The loss of telomere~     repeats diminishes telomeric functional capacity.Telomere length(TL) is important in~     determining telomere function.This is known as the end replication problem and results in a~     gradual decline in TL over time. Consequently,leukocyte TL shortens in a predictable way with~     age by roughly 20-40 base pairs per year. Cellular senescence and subsequent cell death often~     occur when the mean telomere length reaches a critical value.Shortened telomeres and lower~     telomerase are linked to age-related risk factors and disease.Peripheral blood leukocyte~     express telomerase at low levels, which can be measured over a short duration (hours) to~     demonstrate immediate, short-term changes. Shorter mean leukocyte telomere length has been~     shown to be associated with risk of several age-related diseases.The dosage of propofol~     gradually reduced with the aging process. However,it is not known whether the telomere length~     and variation of telomerase in PBL relate to the dosage of propofol and time of consciousness~     disappearance in anesthesia induction. In this exploratory study, the investigators examined~     that the changes of peripheral blood leukocyte telomere length was associated with the dosage~     of propofol and time of consciousness disappearance in anesthesia induction.~      Given the importance of telomeres in nuclear and cellular function, the central role of~     telomere length in determining telomere function,the investigator study that the changes of~     telomere length in peripheral blood leukocyte of patients are associated with the dosage of~     propofol in anesthesia induction.~   "
10506|NCT03429296|"~     Therapeutical hypnosis is proven to be an effective medical support to chemotherapy: it was~     shown that it can reduce the pain, anxiety, fatigue felt by the patient.~      Yet, hypnosis requires the presence of an hypnotherapist, which is why auto-hypnosis could be~     an efficient alternative to handle the side effects of chemotherapy.~      In this study, colorectal cancer and breast cancer patients are either taught auto-hypnosis~     or are taken in standard care for their chemotherapy.~      The life quality score (QLQC30) assessed during and after chemotherapies will determine if~     auto-hypnosis is a good medical support in chemotherapies' adverse effects management.~      The proven benefices of auto-hypnosis in the handling of the side effects of chemotherapies~     could improve the quality of life of cancer affected patients.~   "
10507|NCT03429283|"~     Data extraction from bacteriological laboratory of Martinique University hospital to~     determine the frequency and the distribution of nosocomial infections due to Achromobacter~     xylosoxidans (ACHX), an emerging multi-resistant environmental bacteria. The specific~     tropical environment and climatic conditions in Martinique may favor ACHX development and the~     investigators suppose that this new opportunistic pathogen can represent a danger for~     hospitalized patients. The aim of our study is to describe the most affected population and~     try to identify the main environmental sources of contamination.~   "
10508|NCT03429270|"~     A Pivotal Study to Assess the Performance, Safety and Usability of a New 5 French Air-Charged~     Catheter for Performing Urodynamic Studies on Pediatric Subjects~   "
10509|NCT03429257|"~     This prospective cohort study focuses on the relationship between maternal environmental~     enteric dysfunction (EED) and maternal aflatoxin B1 exposure and birth outcomes, particularly~     infant anthropometry and gestational age, in Mukono, Uganda.~   "
10510|NCT03429244|"~     The overall objective of this Early Phase Clinical Trial is to begin defining the accuracy of~     68Ga-PSMA-11 for detecting the location and size of clinically significant prostate cancer~     lesions in low and intermediate risk disease.~      A molecularly-targeted probe (68Ga-PSMA-11), coupled with an advanced clinical imaging system~     (PET-MRI), will improve accuracy during biopsy and staging. We propose detailed intra-lesion~     whole-mount pathologic analysis as the gold standard for critically assessing PSMA PET~     accuracy in patients undergoing surgery, and blinded PSMA PET-MRI comparison with standard~     multi-parametric MRI (mpMRI) for patients having biopsy on active surveillance. This~     intensive testing of the accuracy and value of PSMA-based tracers requires our unique~     collaboration of surgeons, radiologists, pathologists, and imaging scientists with decades of~     experience and innovation.~   "
10511|NCT03429231|"~     Observational study about quality of life in postmenopausal women taking coenzyme Q compared~     to another group of women of the same age who do not take it~   "
10512|NCT03429218|"~     TP-0184 is a potent inhibitor of ALK2 or ACRV1 kinase, a constitutively active~     serine/threonine receptor kinase due to activating mutations or upregulated upstream~     signaling pathways. This is a Phase 1, open-label, dose-escalation, safety, pharmacokinetics,~     and pharmacodynamic study, with a purpose of determining the maximum tolerated dose (MTD) and~     dose-limiting toxicities (DLTs) of oral TP-0184 administered daily for 28 days in patients~     with advanced solid tumors.~   "
10514|NCT03429192|"~     A study to compare patient survivals in the N2 patients with non-small cell lung cancer in~     the subgroups of lymph skip metastases and non-skip metastases~   "
10733|NCT03426332|"~     The management of adrenal crisis is often problematic and the time to adequate treatment is~     frequently delayed.The aim of the study is to evaluate the management of adrenal emergencies~     requiring parenteral glucocorticoid treatment by a prospective multicenter study in patients~     with chronic adrenal insufficiency.~   "
10515|NCT03429179|"~     Lower extremities surgery in orthopedics mostly adopt spinal anesthesia, it is characterized~     by fewer complications in central nervous system, good analgesic effect, less drug use and~     the exact effect of anesthesia. And it is especially suitable for the elder patients with~     complicated preoperative complications, poor tolerance to narcotic drugs, and narrow range of~     tolerating circulation fluctuations. But because the patients are awake during the operation,~     the surgical stimulation and psychological stress can aggravate the fear and anxiety of the~     preoperative anxiety patients which would make patients suffer from postoperative sleep~     disorder and a variety of complications. The purpose of this paper is to observe after using~     butorphanol for sedation in the operation, the correlation between the degree of preoperative~     anxiety and the time of achieving satisfactory sedation during the operation and meanwhile~     observe the correlation between the degree of preoperative anxiety and postoperative sleep~     quality of patients~   "
10516|NCT03429166|"~     Military sexual trauma (MST) is a common duty-related stressor which occurs among one in four~     female Veterans and is associated with substantial concerns about social isolation and high~     rates of PTSD. Women with MST also experience numerous person-level barriers to care~     including the desire to avoid male-dominated VA clinics, transportation difficulties and~     childcare responsibilities. Treatment programs that address the social and mental health~     needs of this population and acknowledge barriers to care that disproportionately affect~     women are lacking. The proposed study will use a hybrid effectiveness-implementation design~     to evaluate the in-home delivery of a gender-sensitive, evidence-based coping skills program~     to improve social and role functioning as well as reduce PTSD and will prioritize enrolling~     rural women in a representative manner. If the program is found to be successful at improving~     social functioning and PTSD, and in reducing barriers to care, it will provide a tremendous~     benefit to women Veterans with MST, particularly those in rural areas.~   "
10517|NCT03429153|"~     New ESC 2015 recommendations with encouragement to set up a Multidisciplinary Consultation~     Meeting to discuss the medical and surgical management of endocarditis, set up at Strasbourg~     University Hospital in October 2016: Impact and benefits~   "
10518|NCT03429140|"~     This research study is designed to allow the investigator to answer many questions about the~     reasons why anterior cruciate ligament (ACL) injury leads to knee pain and disability and~     osteoarthritis.~      The purpose of this research is to gather information on how safe and effective Gel-One is in~     alleviating knee pain following ACL surgery.~   "
10519|NCT03429127|"~     The purpose of this study was to investigate whether the balanced fluids therapy change~     plasma osmolality in neurosurgical procedures due to brain tumors, meningeomas and~     arterio-venous malformation.~   "
10520|NCT03429114|"~     The study will examine the neural and behavioral correlates of emotion regulation in~     adolescents engaging in binge eating and/or purging and healthy adolescents. Furthermore, it~     will look at the influence of executive function on emotion regulation in this population.~     This study will allow us to gain further understanding of the neural basis of emotion~     regulation in this age group. Moreover, this study supports the need to develop new treatment~     approaches based on a better understanding of the brain processes associated with eating~     disorders.~   "
10521|NCT03429101|"~     This is a Phase 1b, open-label, multicenter study to determine the Maximum Tolerated Dose~     (MTD) or Maximum Administered Dose (MAD) of poziotinib when administered with standard dosing~     of T-DM1 (3.6 mg/kg IV on Day 1 of each 21-day cycle) in women with advanced or metastatic~     HER2+ breast cancer. The poziotinib dose identified in Part 1 of the study will be used in~     combination with standard dose of T-DM1 in Part 2 of the study to confirm the poziotinib dose~     and evaluate the preliminary efficacy of the combination therapy.~   "
10522|NCT03429088|"~     The investigators conducted a pilot study to determine if telephone counseling, in a health~     care setting that routinely assesses physical activity of its members, is a feasible approach~     to improve physical activity among patients with diabetes and prediabetes. The investigators~     built on an existing innovation at Kaiser Permanente, in which physical activity is assessed~     at every outpatient visit. The primary aims were to (1) pilot study elements, including~     database identification of patients; recruitment, training and engagement of health care~     providers; patient recruitment; data collection procedures; and a 24-week intervention, and~     (2) to assess feasibility and obtain feedback from key stakeholders on the approach.~   "
10523|NCT03429075|"~     This is a randomised double-blind clinical trial. The aim is to compare the efficacy and~     mechanisms of action of psilocybin, the primary psychoactive substance in 'magic mushrooms',~     with the SSRI (selective serotonin reuptake inhibitor) escitalopram for major depressive~     disorder (MDD).~   "
10524|NCT03429062|"~     This study will compare the benefits of two community based exercise programs, personal~     training and whole body vibration on balance and gait in people with Multiple Sclerosis.~     Anyone with a diagnosis of MS can participate in the personal training. Only people who can~     walk with or without an assistive device with a diagnosis of MS can participate in the Whole~     Body Vibration. Pre testing and post testing will be completed using balance and gait~     measures and self reporting measures for balance confidence and impact of MS. The program~     will run two times per week for six weeks.~   "
10525|NCT03429049|"~     This is a phase 3, randomized, double-blind, placebo-controlled, single injection, 52-week~     study to evaluate the efficacy and safety of CNTX-4975-05 in subjects with chronic,~     moderate-to-severe osteoarthritis knee pain.~   "
10539|NCT03428854|"~     Examination of genomic and biologic responses to LNG-IUS in patients with adenomyosis.~   "
10540|NCT03428841|"~     The study involves assessment of hearing and visual complications along with headache after~     accidental dural puncture in patients receiving epidurals. Hearing loss will be assessed by~     clinical examination and audiometry testing, while visual complications will be assessed by~     clinical examination. The patients will receive standard treatment for headache in the form~     of drugs and if required an epidural blood patch ( injecting patient's blood in the epidural~     space). The course of these complications and response to treatment will be investigated over~     a period of time.~      Audiometry results from patients with dural puncture will be compared to those of patients~     who also had epidurals, but without a dural puncture.~      The investigators hypothesize that audiovisual complications occur more frequently in~     patients having accidental dural puncture with epidural needle and that the symptoms resolve~     with the administration of epidural blood patch.~   "
10526|NCT03429036|"~     Background:~      Researchers want to learn more about head and neck disorders. Understanding these disorders~     could help them find better treatments. To do this, they are collecting tissue samples for~     research.~      Objective:~      To create a repository of tissue samples and data to better study conditions of the head and~     neck.~      Eligibility:~      People who had or will have tissue samples taken because of a head or neck disorder. They~     must be ages 3 and older and not pregnant to join Part 2.~      Design:~      Participants will be screened with a questionnaire, medical history, and physical exam.~      Part 1. Participants will give permission for any of their tissue samples leftover from~     private care or other research protocols to be used.~      If participants tissue did not contain normal tissue or if they have a condition that~     suggests a genetic issue, they will be invited to join Part 2.~      Part 2: Participants will have additional samples collected. These could be:~        -  Blood: Blood is drawn through a needle in the arm.~        -  Cheek swab or brushing: A cotton swab or small brush is rubbed inside the cheek.~        -  Saliva: They rinse their mouth with water and spit into a tube or cup.~        -  Skin biopsy: They are injected with a numbing drug. A biopsy tool removes a small piece~          of skin.~        -  Mucosal biopsy: They are injected in the mouth with a numbing medication. A small piece~          of tissue from the inside of the cheek is removed.~      Participants samples will be used for future research, including genetic testing.~   "
10527|NCT03429023|"~     This is an observational chart review of all patients with confirmed and probable diagnosis~     of mucormycosis at 19 centers across Indian hospital. Data will collect using a standardized~     CRF. All collected data will be entered into a database prior to analysis. Broadly data will~     be collected on demography, clinical characteristics, diagnosis, treatment and outcome for~     each patient. Patient will continue to receive treatment as per treating physicians advise.~     Primary outcome for this study will be overall survival at 45 & 90 days.~   "
10528|NCT03429010|"~     This study is going to research the hypothesis that to strengthen the comprehensive treatment~     of perioperative anesthesia is possible to improve the prognosis of patients with hip~     fracture and reduce mortality. This is a randomized controlled pilot study aimed to elderly~     patients with hip fracture on one side and needing surgical treatment.~   "
10529|NCT03428984|"~     Primary Objective: To characterize the pharmacokinetic (PK) profile of EXPAREL when~     administered as a posterior intercostal nerve block.~      Secondary Objective: To assess the safety and tolerability of EXPAREL in this surgical model.~   "
10530|NCT03428971|"~     It is suggested that P-wave terminal force (Ptf), a product of the amplitude (PAM) and the~     duration (PT) of the terminal phase of P-wave in lead V1, shows early delay in left atrial~     conduction, observed earlier that the dilatation of left atrium.~      The aim is to follow PT, PAM and Ptf changes during 5-year follow-up (5FU) and examine the~     relation of these changes to the number of AF episodes requiring hospitalisation (HOSP) for~     restoration of sinus rhythm (RSR).~   "
10531|NCT03428958|"~     This is a two-part study of NUC-3373 administered every 2 weeks as an intravenous infusion,~     in separate combinations with leucovorin, oxaliplatin, oxaliplatin + bevacizumab, oxaliplatin~     + panitumumab, irinotecan, and irinotecan + cetuximab. The primary objective is to identify a~     recommended dose for NUC-3373 when combined with these agents.~   "
10532|NCT03428945|"~     The study is a 2-arm, double blinded, multicenter, 2:1 randomized, placebo controlled~     clinical trial. Subjects will receive hydroxychloroquine or placebo and close monitoring for~     progression of T1D.~   "
10533|NCT03428932|"~     The purpose of this study is to determine if improving diabetes control by better controlling~     blood sugars, will help improve or normalize brain function as compared to routine diabetes~     care. We will use either the patient's own insulin routine (injections or insulin pumps) or a~     closed-loop insulin pump (Medtronic 670G). This system uses a continuous glucose monitor~     (CGM) and an insulin pump to automatically give insulin and may improve control of blood~     sugars.~   "
10534|NCT03428919|"~     Conventionally, ICSI was initially developed and has been shown to be an effective treatment~     for male factor infertility. It is increasingly being used for patients without a male factor~     diagnosis, despite the lack of clinical evidence to support its use. Moreover, ICSI is an~     invasive and expensive procedure. This multi-center, randomized, controlled, parallel-group~     trial will be conducted to compare the effectiveness of ICSI versus conventional IVF in~     infertile couples scheduled for IVF treatment, in whom the male partner has normal sperm.~   "
10535|NCT03428906|"~     To investigate whether and how intranasal oxytocin of 8IU treatment will alter the topology~     of functional brain network in resting-state and multiple tasks in healthy males.~   "
10536|NCT03428893|"~     Osteoarthritis is the leading cause of disability in the U.S, particularly in older adults.~     Exercise is an evidence-based treatment option that improves pain and disability outcomes in~     adults with osteoarthritis, but adherence to prescribed exercise is generally low. Technology~     such as mobile applications (apps) for smartphones and tablets offers the potential to~     support exercise adherence through evidence-based components and enhanced communication~     between physical therapists and patients. The investigators aim to test mobile app-supported~     physical therapy exercise prescription compared to standard care. The investigators propose~     to use a two-arm randomized control trial with subjects in the intervention receiving mobile~     app-supported physical therapy exercise prescription and the control group receiving usual~     care physical therapy exercise prescription (paper handouts and verbal instruction). No known~     studies have assessed the impact of technological integration on adherence with PT exercises~     for OA. Current approaches such as therapist drawn pictures, hand-written or print-ready~     instructions do not account for patient communication preferences or ability to translate~     drawings into physical action. Mobile technology offers a potential solution to~     patient-centered care but has not been evaluated. This study will provide valuable~     information on effectiveness and user perspectives to key stakeholders such as patients,~     health care administrators, physical therapists and app designers.~   "
10537|NCT03428880|"~     Subarachnoid morphine (SAM) is the gold standard for treating postoperative pain after~     cesarean delivery (CD) but it has undesirable side effects, that's why the aim of our study~     is to identify whether ultrasound-guided Quadratus lumborum block type 3, a new regional~     anesthetic technique that blocks the abdominal wall neural afferents, can provide at the same~     time better postoperative analgesia after CD with less side effects~   "
10538|NCT03428867|"~     goal of this study is to check the effecivity, feasibility and toxicity of the~     chemoradiotherapy and hyperthermia~   "
10544|NCT03428789|"~     The sensory recovery of the breast remains an undervalued aspect of breast reconstruction and~     surgical reinnervation is not regarded as a priority by most reconstructive surgeons. A~     prospective study was conducted of all patients who underwent either innervated or~     non-innervated DIEP flap breast reconstruction in Maastricht University Medical Center and~     returned for follow-up between September 2015 and July 2017. Semmes-Weinstein monofilaments~     were used for sensory testing of the breast. This study showed that nerve coaptation in DIEP~     flap breast reconstruction resulted in a significantly improved sensation of the~     reconstructed breast compared to non-innervated flaps.~   "
10545|NCT03428776|"~     Although coverage for primary childhood immunizations has improved, a significant proportion~     of young children and pregnant women living in low-resource settings remain inadequately~     immunized. While young children receive some primary vaccines, many are never fully~     vaccinated. Progressive decline in immunizations are in large part attributable to poor~     follow-up and compliance. Major challenges include maintaining immunization records linked to~     positive identification of the individual child, incentivizing follow-up and return~     immunizations and efficiently identifying and targeting non-compliant subjects. Mobile-phone~     costs have decreased dramatically in the developing world with rapid proliferation of web and~     mobile-phone connectivity. Novel approaches that integrate these modern technologies with~     existing resources in low and middle income countries can cost-effectively address these~     challenges. In this proposal, investigators will evaluate a novel software platform,~     utilizing biometric identification and of subjects, paired with intelligent and~     subject-aware, mobile-phone reminders and compliance-linked incentives to improve uptake and~     coverage of primary vaccinations in young children.~   "
10546|NCT03428763|"~     The aim of this study is to explore whether the effectiveness of home-based disease activity~     monitoring via a home-based (eHealth) intervention is superior to standard clinical disease~     activity assessment in obtaining and maintaining a low(er) disease activity in patients with~     rheumatoid arthritis (RA).~   "
10547|NCT03428750|"~     Subjects will be screened for study eligibility within 14 days prior to enrolling in this~     study. Subjects with 2 treatment areas (bilateral buttocks) with moderate or severe levels of~     cellulite as independently assessed by the subject using the Patient Reported Photonumeric~     Cellulite Severity Scale (PR-PCSS) and by the Investigator using the Clinician Reported~     Photonumeric Cellulite Severity Scale (CR-PCSS) will be eligible. The eligibility of the~     buttocks will be confirmed on Day 1. Once the eligibility of the buttocks is confirmed,~     subjects will be randomly assigned to a treatment group (EN3835 0.84 mg per buttock or~     placebo) in a 1:1 ratio within an investigational site. Each subject will receive a treatment~     course which consists of up to 3 treatment visits (sessions), separated by 21 days (ie, Days~     1, 22, and 43). Each treatment visit will consist of 12 injections (0.3 mL per injection of~     EN3835 0.07 mg/injection or placebo; 0.84 mg in 3.6 mL per buttock) in each of the two~     buttocks for a total volume of 7.2 mL (1.68 mg). Selection of dimples to be treated in the~     buttocks will be at the discretion of the Investigator. End of study will occur at study day~     71.~   "
10548|NCT03428737|"~     The weaning of mechanical ventilation is difficult period. This period is particularly~     difficult for patient with obstructive chronic respiratory disease and a long mechanical~     ventilation is associated with an increased risk of infectious complication, cardiac~     dysfunction, muscular weakness or barotromatism. No guideline is available on the ventilator~     mode to use during the night. In weaning period, some studies have demonstrated that~     nocturnal control ventilation during the weaning period improved the quality and the quantity~     of sleep. The hypothesis is that use of nocturnal controlled mechanical ventilation could~     decrease the weaning period duration and the ventilation weaning failure because of a sleep~     improvement.~      The main objective is to compare mechanical ventilation weaning period duration according to~     the nocturnal ventilator mode (pressure controlled ventilation versus pressure support~     ventilation) in patients with an obstructive respiratory disease. A secondary objective is to~     evaluate the rate of weaning failure after the first extubation according to the nocturnal~     ventilator mode and to evaluate the sleep during the weaning period according to the~     nocturnal ventilator mode.~   "
10549|NCT03428724|"~     A randomized control trial comparing a standard bowel preparation for colonoscopy with an~     individualized bowel preparation strategy based on patient characteristics~   "
10550|NCT03428711|"~     The objective of the study is to demonstrate the superiority of the mesoglycan (Prisma®),~     compared to placebo, in reducing the incidence of thromboembolic complications (relapse /~     extension of superficial venous thrombosis (SVT), deep venous thrombosis (DVT), pulmonary~     embolism (PE)) in patients who have completed the cycle of therapy of the acute phase after~     superficial vein thrombosis.~   "
10551|NCT03428698|"~     Objective: The study aimed to assess the effect of topical application of an amino acid +~     sodium hyaluronate acid gel after lower third molar extraction.~      Study design: 136 patients requiring lower third molar extraction were enrolled. An amino~     acid + sodium hyaluronate acid (HA) gel was applied to the sockets of the patients in the~     treatment group immediately following extraction; the sockets of the controls were simply~     flushed with a sterile saline solution. 7 and 14 days after surgery, patients' outcomes and~     postoperative complications were evaluated. Cumulative incidence of dehiscence and secondary~     outcome measures were analyzed using a chi-square test.~   "
10552|NCT03428685|"~     Preterm birth (PTB) is a major challenge to perinatal health. It is defined as delivery~     before 37 completed gestational weeks. It accounts for 75% of perinatal deaths and more than~     50% of long-term neurological disabilities, and it is the second most common cause of death~     in children under the age of 5 year. Neonates born preterm are at risk of respiratory~     distress syndrome, chronic lung disease, retinopathy of prematurity, necrotizing~     enterocolitis, intraventricular haemorrhage and sepsis in the short term, as well as cerebral~     palsy, motor and sensory impairment, learning difficulties, and increased risk of chronic~     disease in long run. It is estimated that the societal cost of PTB is $26 billion annually in~     the USA alone.~      Until now, prevention or reduction of PTB is based on identification of risk factors in~     obstetrical history, biochemical markers and short cervix. History of PTB and asymptomatic~     short cervix at the second trimester are both strong predictors for PTB. In women with~     asymptomatic short cervix at the second trimester, vaginal progesterone could effectively~     reduce PTB. Universal cervical length screening followed by treatment with vaginal~     progesterone has been shown to be the most cost effective strategy in preventing PTB. These~     findings were confirmed in meta-analysis.~      Nevertheless, only minority of women may benefit from progesterone treatment if it was being~     started at the second trimester. There is still a large proportion of PTB, which is currently~     not preventable, and the current approach to prevent PTB is far from ideal.~      One possible hypothesis is that the initiation of progesterone treatment would be too late~     for its effect to take place. Therefore, we decide to use oral progesterone in the current~     study. The objective of the study is to determine whether early use of progesterone can~     prevent PTB better when compared with universal screening of cervical length and followed by~     treatment with progesterone in those with short cervix.~   "
10556|NCT03428633|"~     60 patients ASA I-III, undergoing open nephrectomy will be randomly assigned into one of two~     groups, namely group A (n=30), where a thoracic paravertebral block will be performed~     preoperatively and a paravertebral catheter for continuous and patient controlled bolus local~     anesthetic (ropivacaine) doses will be inserted and group B (n=30) where morphine IV will be~     administered at the beginning and the end of operation and postoperatively through patient~     controlled IV doses. NRS scores in static and dynamic conditions, complications, patient~     satisfaction, oxidative stress (through lactic acid, superoxide dismutase, malondialdehyde)~     and NGAL pre- and postoperatively, will be recorded.~   "
10557|NCT03428620|"~     Our purpose is to examine the combined effects of thrust mobilization of the ankle joints in~     conjunction with a six-week rehabilitation program on functional performance in subjects~     reporting chronic ankle instability (CAI).~   "
10558|NCT03428607|"~     This study is a single arm, multi-center phase II study of AZD6738 and olaparib combination~     therapy in patients with relapsed small cell lung cancer (SCLC) as a second or third line~     chemotherapy.~      Patients will receive AZD6738 and olaparib combination therapy. The arm is composed of 45~     patients.~      AZD6738 160mg QD per os administered for 7 days and olaparib 300mg BID per os administered~     daily. One cycle is considered of 28 days.~      Tumour evaluation using RECIST 1.1 will be conducted at screening (within 28 days prior to~     first dose) and every 8 weeks relative to the date, up to week 56, then every 12 weeks until~     objective disease progression (within a window of ± 7 days of the scheduled date).~      Study treatment will be continued until objective disease progression (unless other criteria~     for treatment discontinuation are met). Patients may continue AZD6738 and olaparib beyond~     progression (according to RECIST 1.1), at the discretion of the investigator if they are~     clinically benefiting from the treatment and they do not meet any other discontinuation~     criteria.~      If a patient discontinues study treatment prior to disease progression, they should continue~     to be assessed using RECIST 1.1 until disease progression and then followed up for survival.~      Assessments for survival should be made every 8 weeks following objective disease~     progression. The details of first and subsequent therapies for cancer, after discontinuation~     of AZD6738 and olaparib treatment, will be collected.~      The imaging modalities used for RECIST 1.1 assessment will be CT or MRI scans of chest,~     abdomen and pelvis. RECIST 1.1 scans will be analysed by the investigator on site.~      Patients may also be requested to provide tumour samples from the primary or metastatic~     tumours on progression to understand resistance mechanisms. Sample provision is optional and~     depend on the patient's will.~   "
10559|NCT03428594|"~     The aim of this study was to compare and evaluate efficacy and safety of intravenous~     CKD-11101 versus Darbepoetin alfa in patients who have renal anemia receiving hemodialysis.~   "
10560|NCT03428581|"~     The researchers are trying to answer if axillary reverse mapping (ARM) with lympho-venous~     bypass (LVB) in patients undergoing an axillary lymph node dissection reduces the rate and~     severity of post-operative lymphedema of the arm.~   "
10561|NCT03428568|"~     The aim of the study is to use Melanole, a herbal extract from Nigella sativa, for treatment~     of gastritis. The effect of Melanole will be compared between participants (including H.~     pylori and non-H.pylori infected patients), with the triple therapy and Standard of care~     treatment of gastritis, respectively.~      All participants will be examined before and after the administration of Melanole. The~     results showing a relief of gastritis symptoms for non-H. pylori patients and partial or~     complete eradication of H. pylori for H.pylori infected patients will be evaluated.~   "
10562|NCT03428555|"~     Major Depressive Disorder in adolescence is prevalent and debilitating. Our group aims to~     improve treatment response through the use of an Integrated Care Pathway (ICP) based on a~     high quality Clinical Practice Guideline and measurement-based care (MBC; where periodic~     symptom scale scores are used to make treatment decisions). We propose a controlled clinical~     trial comparing ICP to treatment-as-usual (TAU) across two sites.~   "
10563|NCT03428542|"~     This study aims to evaluate the benefits of yoga as a 'mind-body' practice, by measuring it's~     effects on health-related psychological and physiological variables. The study also aims to~     investigate whether an association exists between subjective (psychological) and objective~     (physiological) measures, with a particular focus on stress as the primary outcome.~   "
10564|NCT03428529|"~     A randomized two-arm study comparing preoperative CRT using oral capecitabine versus bolus~     5-FU/LV concomitant to external beam radiation (50.5 Gy/28 fractions) for locally advanced~     rectal cancer. Main outcome was clinical response assessed using MRI and endorectal US 6-8~     weeks after CRT. Secondary endpoints were pathological response, adverse effects, sphyncter~     preservation, quality of life, OS and DFS.~   "
10565|NCT03428516|"~     The present study aims to compare muscle sympathetic neural activity by microneurography~     after one month treatment of fixed versus auto-adjusting CPAP treatment and its impact on~     arterial blood pressure~   "
10566|NCT03428503|"~     -  Currently, paracetamol and nonsteroidal antiinflammatory drugs are widely used by~          emergency physicians in Turkey for the treatment of patients with acute traumatic~          musculoskeletal pain.~        -  The objective of the study is compare the efficacy of intravenous dexketoprofen with~          paracetamol in the treatment of acute traumatic musculoskeletal pain.~   "
10567|NCT03428490|"~     Alcohol use disorders (AUD) and social anxiety disorder (SAD) are highly comorbid and~     associated with significant impairment. Social anxiety comorbidity is associated with poorer~     addiction treatment engagement and outcomes. Thus, addressing underlying SAD symptoms that~     may lead to and maintain alcohol problems, as well as undermine successful treatment for AUD,~     is warranted. This proposal aims to develop and evaluate a fully integrated outpatient~     program for comorbid SAD and AUD that weaves evidence-based treatment for SAD (i.e.,~     exposure-based cognitive behavioral therapy) into a traditional, evidence-based treatment for~     AUD.~      First, the investigators will develop the protocol for the fully integrated treatment (FIT).~     The overarching goal of FIT will be to simultaneously deliver AUD and SAD treatment.~     Development will be an iterative process guided by previous research (including our own), and~     by input from clinicians, administrators, and patients in an outpatient substance use~     disorder treatment clinic. After the protocol is developed, the investigators will use their~     established clinician training procedures to train clinicians at their community partnered~     clinic to competently deliver the intervention. After protocol development and clinician~     training, the investigators will conduct a pilot randomized clinical trial (RCT) comparing~     the efficacy of our fully integrated treatment (FIT) for comorbid alcohol use and social~     anxiety disorders to usual care (UC) in the community substance use disorder specialty~     clinic. The goals of the RCT will be to gather data regarding acceptability, feasibility, and~     preliminary efficacy of the FIT protocol. The investigators will randomize treatment-seeking~     participants (N = 60) who have comorbid SAD and AUD. The investigators will assess treatment~     engagement, social anxiety outcomes, and alcohol use outcomes at baseline, 3-months, and~     6-months from baseline. The investigators will also gather qualitative and quantitative~     acceptability data from patients after completing FIT, which may guide final refinements of~     FIT prior to testing in a larger-scale grant.~      The knowledge gained from this investigation has the potential to significantly improve the~     treatment of alcohol use disorders and make a significant public health impact. The focus on~     direct translation to community practice paradigms and the emphasis on full mental health and~     addiction treatment integration significantly advance the field.~   "
10589|NCT03428204|"~     Percutaneous angioplasty with balloon dilation is the method of choice for the treatment of~     most femoropopliteal artery lesions. After balloon dilatation, arterial wall dissection with~     flow limiting dissection or recoil with residual stenosis often require additional procedures~     such as stent placement or prolonged balloon dilation. A shorter balloon inflation time of 30~     sec will be accompanied by a higher number of flow limiting dissection or recoil, demanding a~     time consuming and expensive stent placement or balloon redilatation. The effect of different~     balloon inflation times has only been assessed ones in peripheral balloon angioplasty with~     better outcomes after prolonged balloon inflation.~   "
10568|NCT03428477|"~     A significant proportion of patients who undergo liver surgery to remove bowel cancer that~     has spread to the liver (metastases) develop disease recurrence and die from the disease. A~     previous small study (the EMT study) suggested a possible survival benefit in patients who~     took the naturally-occurring omega-3 fatty acid EPA (a fish oil supplement) before liver~     surgery. The EMT2 study is a larger study which will recruit 448 men and women with liver~     metastases from bowel cancer. Trial participants will receive either Icosapent Ethyl (pure~     EPA derived from fish oil) or placebo (dummy capsules). EMT2 will investigate whether~     patients who take this supplement before liver surgery and for up to four years after~     surgery, remain free of recurrence for longer than those who take placebo (dummy capsules)~   "
10569|NCT03428464|"~     Metabolic acidosis is associated with vascular endothelial dysfunction and is a common~     complication in patients who have received a kidney transplant. Kidney transplant recipients~     (KTR) with lower serum bicarbonate levels, even within the normal range, have an increased~     risk of graft loss and mortality. The investigators propose a prospective, double-blind,~     randomized, placebo-controlled, 18-week crossover pilot study to examine the effects of~     sodium bicarbonate on vascular endothelial function, graft function, and cognitive function~     in 20 KTR patients.~   "
10570|NCT03428451|"~     The study is designed to evaluate the efficacy and safety of intravenous infusion of~     hypertonic saline in BPH patients, candidates for TURP surgery using the monopolar electric~     resectoscope in prevention of hyponatraemia and TUR syndrome.~   "
10571|NCT03428438|"~     The innovation in this preliminary study is the use of message reminders in patients after~     myocardial infarction in stage I of rehabilitation (ie discharge from hospital) at home via~     SMS, compared with studies of patients undergoing cardiac rehabilitation (stage II)in the~     hospital physiotherapy department.~   "
10572|NCT03428425|"~     The purpose of this study is to investigate the efficacy and safety of HIPEC plus apatinib~     and S-1 in the conversion therapy of gastric cancer with positive exfoliative cancer cells~   "
10573|NCT03428412|"~     This is a multi-center, randomized, double-blind, controlled trial to compare the efficacy of~     two therapies for patients with AECOPD. 378 subjects will be randomly assigned to one~     therapies (conventional drug, and the combination of conventional drug and TCM) for 14 days~     treatment. After the treatment period, subjects in two arms will be followed up for 4 weeks.~     The primary outcomes will include COPD Assessment Test (CAT), and secondary outcomes include~     treatment failure rate, treatment success rate, hospitalization time, hospital admission~     rate, endotracheal intubation rate, mortality and quality of life (COPD-PRO, SF-36).~   "
10574|NCT03428399|"~     Mastectomy is a major surgery that can have a profound effect on women's psychosocial~     wellbeing, including elevated depression and body image distress. Reconstructive breast~     surgery aims to improve patients' psychosocial adjustment to mastectomy, yet for some women~     substantial distress persists after reconstruction. However, very little is known about risk~     or protective factors for persistent depression or body image distress following mastectomy~     with reconstruction. The present study aims to address this critical gap. In women undergoing~     mastectomy with breast reconstruction, the investigators will assess risk and protective~     factors for post-surgery depression severity and body image distress.~   "
10575|NCT03428386|"~     The present study aims to explore the impact of combining laparoscopic greater curvature~     plication with a single gastro-ileal anastomosis in the same manner of single anastomosis~     sleeve ileal bypass on weight loss and postoperative complications. The objective of this~     combined procedure is to reduce the high intraluminal pressure that results after~     laparoscopic greater curvature plication owing to reduced intraluminal space which can lead~     to suture line leakage, vomiting, and gastroesophageal reflux disease. Another objective is~     to add a malabsorptive element to the restrictive effect of laparoscopic greater curvature~     plication and to induce early satiety in patients by distention of the distal bowel with~     nutrients immediately after meals, similar to the way that single anastomosis sleeve ileal~     bypass works.~   "
10576|NCT03428373|"~     The intended pilot study is designed as a multicenter randomized controlled clinical trial,~     comparing the impact of two different therapies including ASA vs. Rivaroxaban in newly~     diagnosed or relapsed and refractory multiple myeloma patients treated with Lenalidomide~     Dexamethasone (Len-Dex) combination therapy~   "
10577|NCT03428360|"~     This Phase 3, multicenter, open-label study of chronic, intermittent use of study drug (DBSF)~     is designed to evaluate the safety and tolerability of the buccal formulation of diazepam in~     children, adolescents and adults with acute repetitive seizures.~   "
10578|NCT03428347|"~     This Phase I clinical trial was developed to study drug safety, tolerability, and~     pharmacokinetics of the medicine for Ebola fever emergency prevention based on monoclonal~     recombinant antibodies in single use in healthy volunteers with a dose escalation. A~     consecutive recruitment of people who signed the Informed Consent Form into three groups of~     volunteers with different drug doses is made according to the volunteers' screening results.~     The total number of volunteers receiving the drug will be not less then 25 people.The purpose~     of this study is to assess safety, tolerability, and pharmacokinetics of a medicine for Ebola~     fever emergency prevention based on monoclonal recombinant antibodies in a single dose in~     healthy volunteers.~   "
10579|NCT03428334|"~     This is a single-arm, open label, Phase II study of Roflumilast in stable-state non-cystic~     fibrosis bronchiectasis subjects.~      Bronchiectasis refers to a suppurative lung condition characterized by pathological~     dilatation of bronchi. The predominant aetiology of bronchiectasis in the Western population~     is related to cystic fibrosis (CF), which is genetically determined. Bronchiectasis due to~     other causes are generally grouped under the term non-CF bronchiectasis, which accounts for~     practically all cases that are seen commonly in Hong Kong and many other Chinese populations.~      The main pathogenesis of non-CF bronchiectasis involves airway inflammation, abnormal mucus~     clearance and bacterial colonization, resulting in progressive airway destruction and~     distortion. The current treatment strategies mainly focus on targeting the key elements in~     the pathogenesis of non-CF bronchiectasis.~      In patients with bronchiectasis, there is also neutrophilic inflammation as in COPD. It is~     hypothesized that roflumilast can improve airway inflammation, sputum volume and sputum~     inflammatory markers in patients with bronchiectasis.~      This study aims to investigate the effect of short-term (4-week) treatment with roflumilast~     on neutrophilic airway inflammation in stable-state non-CF bronchiectasis.~   "
10580|NCT03428321|"~     Percutaneous thermoablation in an effective local curative treatment in patients with~     cirrhosis and HCC smaller than 3 cm in diameter (BCLC 0-A).~      Around 30% of HCC patients referred for percutaneous ablation were regarded as non-feasible~     because of a difficult-at risk location or undetectable nodules.~      We used percutaneous thermoablation to treat HCC on high risk locations (subcapsular or liver~     dome) with or without lipiodol marked (for undetectable HCC).~      No clinical study has been published so far to compare percutaneous thermoablation of HCC on~     liver dome CT guided with artificial pneumothorax and lipiodol marked, and percutaneous~     thermoablation of HCC guided by ultrasonography (non subcapsular, distent form diaphragm).~      This retrospective study evaluate the overall survival, the local tumor progression or~     distant liver progression after percutaneous ablation for HCC and determine prognostic~     factors.~   "
10581|NCT03428308|"~     In Denmark, around 2 % of the population live with severe mental disease. People with severe~     mental disease live 15-20 years less than the general population. The majority of the years~     of life lost are a consequence of the excess mortality due to somatic disease. The high~     prevalence of somatic disease among people with severe mental disease can be largely~     attributed to physical inactivity, unhealthy diet and side effects from psychopharmacological~     drugs. Apart from the impacts of unhealthy lifestyle and medication side effects, research~     suggests that individuals with severe mental disease do not receive the same treatment for~     their somatic diseases as do the rest of the population. The inequality in diagnostics and~     treatment can be attributed to stigmatization from healthcare providers and patients' lacking~     awareness of symptoms and reluctance to seek medical care. Further, the increasing~     specialization within both somatic and psychiatric care has led to a division between these~     two treatment systems (8,9). Patients with severe mental disease who simultaneously have one~     or more somatic diseases need their treatment to be coordinated; such treatment should span~     general practice, the municipality and the psychiatric and somatic hospital. Accordingly, the~     following elements are necessary to create effective and coordinated treatment trajectories:~     detailed preparation, qualitative process evaluation as an integrated part of the courses of~     treatment, and involvement of all stakeholders from the start.~      The overall aim of the project is to optimize the detection of selected chronic somatic~     diseases, including cardiovascular disease (ischaemia and heart failure), diabetes,~     hypertension and high cholesterol, in individuals with schizophrenia, schizoaffective~     disorder or bipolar disorder; to initiate medical treatment; and to ensure treatment~     compliance among patients.~      Accordingly, the project has the following objectives:~        -  To develop an intervention targeting individuals with schizophrenia, schizoaffective~          disorder or bipolar disorder that can optimize the detection of selected chronic somatic~          diseases, including cardiovascular disease (ischaemia and heart failure), diabetes,~          hypertension and high cholesterol~        -  To test whether the developed intervention can optimize the detection of cardiovascular~          disease (ischaemia and heart failure), diabetes, hypertension and high cholesterol in~          individuals with schizophrenia, schizoaffective disorder or bipolar disorder~      The project's hypotheses are that an interdisciplinary and intersectoral intervention~     targeting individuals with schizophrenia, schizoaffective disorder or bipolar disorder can~        -  optimize detection of cardiovascular diseases (ischaemia and cardiac insufficiency),~          diabetes, hypertension and high cholesterol by systematic screening in general practice~        -  lead to initiation and maintenance of relevant medical treatment. Moreover, we~          hypothesize that the complete intervention in a long-term perspective will lead to~          decreased mortality within the target group.~   "
10582|NCT03428295|"~     The objective of this study is to test two different operating modes of the latest version of~     the Dose Safety artificial pancreas system (APS), the Dose Safety Controller (DSC version~     2.3), in a population of subjects with type 1 diabetes (TID) in a hospital CRC setting. The~     first mode is the Fully Automated Closed Loop (FACL) mode, in which all insulin delivery is~     directed by the controller and the second mode is the Hybrid Closed Loop (HCL) mode, in which~     insulin delivery is a hybrid between controller directed delivery and user directed insulin~     delivery. There will be two study arms: HCL and FACL. No comparisons will be made between the~     two arms.~   "
10583|NCT03428282|"~     The aim of this study is to evaluate the effectiveness of two different audiovisual~     distraction techniques (Audio Video eyeglasses VR BOX/ Tablet) in the management of anxious~     pediatric patients during inferior alveolar nerve block~      Group A (Control group): IAN will be administrated with basic behavior guidance techniques~     and without using any type of distraction aids.~      Group B: IAN will be administrated with using AV eyeglasses VR BOX and wireless headphone.~      Group C: IAN will be administrated with using tablet device and wireless headphone~      All of the children who experienced an inferior alveolar block with/without distraction will~     be assessed by using a combination of measures: Wong-Baker FACES (self-report), pulse rate~     (physiological) and behavior (using FLACC behavior rating scale external evaluator~   "
10584|NCT03428269|"~     Detection of patient deterioration is a major healthcare problem. Indeed, acute clinical~     deterioration of the patient is often preceded by changes of several physiological parameters~     within 6 to 24h before the event occurs. The combination of i) early detection ii) rapid~     response and iii) efficient clinical management influences the patient's prognosis. Education~     of nurses, who are frontline healthcare providers, is therefore essential. Serious games~     might represent an interesting immersive educational tool to train a large number of~     healthcare professionals with high flexibility but assessment of their learning efficacy~     should be demonstrated. A serious game named LabforGames Warning has been developed for~     nursing students with the aims of improving their ability to detect clinical deterioration~     and to promote adequate interprofessional communication. The objective of this study will be~     to compare the respective value of digital simulation (using the above mentioned serious~     game) and a traditional teaching method to improve the clinical reasoning skills necessary to~     detect patient deterioration.~   "
10585|NCT03428256|"~     General anaesthesia involves giving patients anaesthetic and muscle relaxant medications to~     allow transition to sleep and airway relaxation to permit laryngoscopy, respectively. During~     laryngoscopy, a breathing tube is placed to 'secure' the airway. There is therefore a length~     of time from administration of these medications to when the breathing tube is placed, when~     the patient is not breathing and the airway is not secured. This time is known as apnoea~     time. In a patient who is not breathing, blood oxygen levels fall to dangerously-low levels,~     within 1-2 minutes. In order to prevent this, patients breathe 100% oxygen before induction~     of anaesthesia as part of a process known as pre-oxygenation. There are different ways of~     delivering pre-oxygenation, but the common aim is to increase the oxygen reservoir within the~     lungs to give the anaesthetist more time to place the breathing tube. With good~     pre-oxygenation, apnoea times of up to 7 minutes are possible.~      Apnoea time is a potentially hazardous period during induction of anaesthesia and it is~     particularly so in patients with severe obesity. On the one hand, obesity makes the upper~     airway anatomy difficult, and on the other hand, lung collapse (atelectasis) caused by~     abdominal contents compressing the base of the lungs reduces the amount of oxygen available~     within the lungs. Apnoea time can be as short of 30 seconds. Identifying the most effective~     method of pre-oxygenating bariatric patients can therefore significantly improve the safety~     of delivering general anaesthesia to these patients.~      The purpose of the study is to compare effectiveness of different methods of achieving~     pre-oxygenation in bariatric patients. The investigators intend to compare facemask~     pre-oxygenation with a high-flow humidified nasal oxygen.~      The primary outcome measure of interest is time to desaturation to 92% or 18 minutes of~     apnoea.~   "
10586|NCT03428243|"~     A long-term follow-up study to evaluate the safety and efficacy of the Cutera truSculpt~     radiofrequency device for circumferential reduction.~   "
10587|NCT03428230|"~     This is a phase II, single centre, randomised, parallel-group, double-blind, three doses,~     placebo-controlled, exploratory efficacy and safety study. The objective of this study is to~     investigate the efficacy and safety of a single intrathecal injection of Paracetamol 3% (30~     mg/mL) administered at 3 doses to 3 active treatment groups, as compared to placebo, for~     post-operative analgesia in knee procedures up to 40 min duration performed under spinal~     anaesthesia with Chloroprocaine HCl 1%.~   "
10588|NCT03428217|"~     This study is a randomized Phase 2 evaluation of CB-839 in combination with cabozantinib~     versus placebo with cabozantinib in patients with advanced or metastatic Renal Cell~     Carcinoma.~   "
10593|NCT03428152|"~     The primary indication for superior hypogastric (SHP) block is visceral pelvic pain, most~     commonly from malignancy of the ovary, uterus, cervix, bladder, rectum or prostate.~     Percutaneous SHP blocks should be done under guidance of ultrasonography, fluoroscopy,~     magnetic resonance or computed tomography. Because of the close proximity of SHP to major~     vessels, and structures like vertebral column (for posterior) and guts (for anterior) are~     being on the way of the needle, these percutaneous blocks are associated with serious~     complications. Performing SHP during hysterectomy surgery, gives advantages to rule out these~     complications by exploring the whole intraabdominal anatomy.~      The investigators' theory is to find out if SHP blocks (during pelvic surgery) are useful for~     decreasing VAS pain scores and opioid consumption for postoperative pain.~   "
10594|NCT03428139|"~     In this study, we try to evaluate the effect of using ALA as an adjuvant treatment in~     patients scheduled for pulsed radiofrequency treatment (PRFT) of the affected dorsal root~     ganglion (DRG) for treatment of Lumbo-Sacral radicular pain.~   "
10595|NCT03428126|"~     The goal of this clinical research study is to learn if durvalumab and trametinib can help to~     control microsatellite stable (MSS) colorectal cancer. The safety of these drugs will also be~     studied.~      This is an investigational study. Durvalumab is FDA approved and commercially available for~     the treatment of previously treated advanced bladder cancer. Trametinib is FDA approved in~     combination with another drug called dabrafenib for the treatment of unresectable or~     metastatic melanoma with BRAF V600E or BRAF V600K.~      It is investigational to use durvalumab and trametinib to treat MSS colorectal cancer.~      Up to 56 participants will be enrolled in this study. All will take part at MD Anderson.~   "
10596|NCT03428113|"~     ICU patients are at risk for catheter associated urinary tract infection. Frequently patients~     can't tell clinicians if they need to void if the catheter is removed. If clinicians know~     that an accurate volume measurement s of urine volume in the bladder can be obtained when the~     catheter is removed, catheters could be removed earlier and more frequently and thus possibly~     avoid an infection. For this study, measures with ultrasound (directly visualizing the~     bladder to measure), bladder scanner (partially blind measure with placement of scanner over~     the expected bladder location on the skin) and urine catheterized volume will be obtained.~     The investigators also want to know if the technology is user dependent. The study will~     include 2 levels of nurses RN and advanced practice RN (APRN) perform the bladder scanner. An~     APRN and MD will conduct the ultrasound. Ultrasound is technology primarily used by~     physicians but APRNs are using the technology technology more frequently. After these 4~     measurements, the patient's nurse will perform an intermittent straight catheterization~     (catheter inserted, urine drained, and catheter removed) as the gold standard comparison.~   "
10597|NCT03428100|"~     The purpose of this study is to determine the efficacy and safety of baricitinib in~     combination with topical corticosteroids in participants with moderate to severe atopic~     dermatitis who have experienced failure to cyclosporine or are intolerant to, or have~     contraindication to cyclosporine.~   "
10598|NCT03428087|"~     Impedance-based analysis could provide an adequate response to the need to identify a safe~     and reliable tool alternative to bioptic diagnosis. Patients who are candidates for prostate~     biopsy as suffering from urinary symptoms accompanied by clinical suspicions such as high~     total PSA value and / or presence of prostate nodule and / or evidence of obvious lesion to~     available imaging methods will be subjected to impedance measurement. Aim of this study is to~     be able to structure a bivariate analysis of the distribution of impedances detected in~     patients with neoplasia in order to detect test median reference values.~   "
10599|NCT03428074|"~     The study was designed to compare effectiveness and safety of the surgeries of Ivor-Lewis and~     Mckeown in patients with esophageal cancer~   "
10600|NCT03428061|"~     Cardiovascular disease (CVD) contributes importantly to mortality and morbidity. Prevention~     of CVD by lifestyle change and medication is important and needs full attention.~      In the Netherlands an integrated program for cardiovascular risk management (CVRM), based on~     the Chronic Care Model (CCM), has been introduced in many regions in recent years, but~     evidence from studies that this approach is beneficial is very limited.~      In the ZWOT-CASE study the investigators will assess the effect of integrated care for CVRM~     in the region of Zwolle on two major cardiovascular risk factors: systolic blood pressure~     (SBP) and low-density lipoprotein cholesterol (LDL-cholesterol) in patients with or at high~     risk of CVD.~      This study is a pragmatic clinical trial comparing integrated care for CVRM with usual care~     among patients aged 40-80 years with CVD (n= 370) or with a high CVD risk (n= 370) within 26~     general practices. After one year follow-up, primary outcomes (SBP and LDL-cholesterol level)~     are measured. Secondary outcomes include lifestyle habits (smoking, dietary habits, alcohol~     use, physical activity), risk factor awareness, 10-year risk of cardiovascular morbidity or~     mortality, health care consumption, patient satisfaction and quality of life.~   "
10601|NCT03428048|"~     Information gathered from the patients via a disease specific questionnaire will be married~     to data from the National Cardiovascular Data Registry (NCDR®). Details will be continuously~     analyzed and used to direct quality of care at our center. Our institution is categorized as~     a low-volume institution for percutaneous coronary intervention (PCI) for coronary artery~     disease treatment as well as surgical and endocardial ablation for the management of atrial~     fibrillation (Afib). The association between operator volume and quality has primarily~     focused on rare complications, such as mortality. Our aim is to highlight the advantages of~     receiving care close to home. A benefit of offering the procedures to treat diseases at~     centers that have lower volumes is to improve patients' outcomes while also providing more~     convenient access to quality care. The key outcome from the patients' experience is~     alleviation of their symptoms while increasing function and quality of life. To date, there~     have been no studies documenting the health status benefits of PCI and surgical / endocardial~     ablation for coronary artery disease and Afib, respectively with low- volume operators. In~     this study, we sought to examine the feasibility of implementing patient-reported outcomes~     into clinical care and to demonstrate evidence of benefits, from patients' perspectives, of~     receiving treatment by low-volume operators.~   "
10734|NCT03426319|"~     Within this trial, the cardiovascular status and metabolic profile of patients with chronic~     primary adrenal insufficiency is evaluated.~   "
10735|NCT03426306|"~     To evaluate the correlation between pre-surgical 4DCT-ventilation imaging and post-surgical~     lung function.~   "
10602|NCT03428035|"~     Background The nocebo effect describes the association between the expectation of negative~     effects, (e.g. side effects) and the actual occurrence of negative effects. Studies have~     shown that the nocebo effect can be influenced by (risk) communication. Till today there is~     no study that compares different types of information on adverse events regarding the~     strength of the nocebo effect.~      Aim The aim of this pilot randomized controlled trial is to analyse the influence of~     different communication types on the frequency and intensity of adverse events and adherence.~     To increase the relevance and applicability of the results the study intervention builds up~     on package inserts because these are the most widespread form of information on side effects.~      Methods Patients It is planned to include 60 patients in the study.~      Intervention~        -  Modified package insert: simplified and focused on neutral risk perception. The~          representations and formulations are based on the findings from research on~          evidence-based patient information and risk communication. The package insert contains~          the same information as the statutory package insert to ensure that it complies with the~          legal requirements.~        -  Verbal information about side effects: The patient is informed verbally about side~          effects and does not receive any package insert.~      Control Package insert according to EU (European Union) Directive 2001/83 / EC (European~     Commission) (usual package insert).~      Outcomes~        -  Number of patient reported adverse events (primary outcome).~        -  Adherence (correct initiation of therapy, correct intake amount, premature~          discontinuation of therapy).~        -  Resource use (e.g. provider contacts).~      Type of study Monocentric, outcome assessor, three-arm, randomised controlled pilot trial.~   "
10603|NCT03428022|"~     Patients with advanced non-small cell lung cancer (NSCLC) who progress slowly after Epidermal~     Growth Factor Receptor Tyrosine Kinase Inhibitors（EGFR-TKI）resistance will be treated with~     Apatinib and EGFR-TKI. The primary objective is the disease progression free survival of the~     patients.~   "
10604|NCT03428009|"~     The purpose of this study is to (1) investigate the effect of known dystonia-causing~     mutations on brain structure and function, to (2) identify structural brain changes that~     differ between clinical phenotypes of dystonia, and to (3) collect DNA, detailed family~     history, and clinical phenotypes from patients with idiopathic dystonia with the goal of~     identifying new dystonia-related genes. Investigators will be recruiting both healthy control~     subjects and subjects with any form of dystonia. For this study there will be a maximum of~     two study visit involving a clinical assessment, collection of medical and family history,~     task training session, an MRI using the learned tasks, and finally a blood draw for genetic~     analysis. In total, these visits will take 3-5 hours. If the dystonia subjects receive~     botulinum toxin injections for treatment, the participants and their matched controls will be~     asked to come for a second visit.~   "
10605|NCT03427996|"~     This study evaluates the effectiveness and safety rotational atherectomy in routine clinical~     practice.~   "
10606|NCT03427983|"~     This is a pilot study designed to acquire data on the added value of hydrodissection when~     using a corticosteroid injection as a treatment for patients with carpal tunnel syndrome.~     Hydrodissection is part of a standard clinical care injection under ultrasound guidance in~     which the fluid is used to separate the nerve from surrounding structures.~   "
10607|NCT03427970|"~     Adolescent idiopathic scoliosis (AIS) is one of the most prevalent spinal deformity that may~     progress sharply during growth. It is recommended that the physiotherapeutic~     scoliosis-specific exercises should be the first step to treat idiopathic scoliosis to~     prevent/limit progression of the deformity. Three-dimensionally integrated exercise for~     scoliosis is based the theory of physiotherapeutic scoliosis specific exercises, and consists~     of patient education, 3-dimension self-correction, stabilization of the corrected posture and~     training activity of daily living, combined with neuro-motor control, proprioceptive~     training, balance training, etc., forming the individual exercise approach for each patient.~     Nevertheless, the evidence concerning three-dimensionally integrated exercise for scoliosis~     is inadequate. Therefore, the objective of this study is to determine the effect of~     three-dimensionally integrated exercise intervention on the Cobb angle, angle of trunk~     rotation(ATR), sagittal profile, and quality of life, compared to standard care for patients~     with mild AIS.~      Informed consent will be obtained from each patient and one of their parents prior to~     inclusion. Eligible subjects will be randomized by a 1:1 allocation ratio by computer either~     to the experimental group, in which they will perform three-dimensionally integrated exercise~     for scoliosis, or the control group, in which they will receive the standard of care with~     observation according to the Scoliosis Research Society criteria.Blinded assessments at~     baseline and immediately post 6-month intervention will include radiographic measurement,~     trunk rotation, sagittal profile and health related quality-of-life.~   "
10608|NCT03427957|"~     Hysteroscopic endometrial biopsy is usually performed through the classic spoon grasper.~     Recently, a new hysteroscopic grasper with knurled terminal end and cutting jaws was~     designed, in order to improve feasibility of the procedure, reduce its duration and the~     discomfort for the patients.~      This study aims to compare the outcomes of the two hysteroscopic graspers for endometrial~     biopsy in post-menopausal patients.~   "
10609|NCT03427944|"~     To investigate the feasibility of calcium dobesilate in the treatment of microvascular injury~     provides new ideas and theoretical basis for the prevention and treatment of chronic renal~     failure.~   "
10610|NCT03427931|"~     A study assessing glucose variability in subjects with Type 1 Diabetes who have had islet~     transplant.~   "
10611|NCT03427918|"~     Female sexual dysfunction (FSD) includes impairments in sexual desire, arousal, orgasm, and~     genital pain resulting in significant subjective distress. This study is aimed to assess a~     mindfulness-based intervention for improving sexual functioning among women with epilepsy~   "
10647|NCT03427450|"~     The purpose of this clinical study is to demonstrate that the Parsortix™ PC1 system enables~     the capture and harvest of circulating tumor cells (CTCs) from the peripheral blood of~     patients with metastatic breast cancer (MBC) and not from healthy volunteers (HVs). The study~     is also designed to demonstrate that the CTCs harvested by the Parsortix PC1 system from MBC~     patients can be used effectively for different types of evaluations (e.g. cytopathology,~     FISH, qPCR, RNAseq, etc.).~      This is an investigational study. The Parsortix PC1 system is not FDA approved and is~     currently being used for research purposes only.~   "
10612|NCT03427905|"~     Most common forms of hair loss (alopecia) are caused by aberrant hair follicle cycling and~     changes in hair follicle morphology. However, current treatments for alopecia do not~     specifically target these processes. Adipose-derived stromal vascular cells (ADSVCs) that can~     be harvested from fat cells are one of the latest breakthroughs in the aesthetic field. The~     potential use of stem cell-based therapies for the repair and regeneration of various tissues~     and organs offers a paradigm shift that may provide alternative therapeutic solutions. This~     study aimed at the presentation of clinical cases to suggest a therapeutic plan comprised of~     acquisition of small volume of fat, followed by injection of ADSVCs in the scalp. 20 patients~     will be recruited for this study (considering the second group). Hair regeneration will be~     assessed by the pull test, hair quality, and hair density. All patients must show increased~     significant improvement of the hair quality and density. The obtained results must prove the~     efficacy and the safety of the treatment and satisfaction of the patient that will confirm~     the quality of the results.~   "
10613|NCT03427892|"~     The investigators will conduct an 8-week, non-randomized, open-label study of brexpiprazole~     in 20 persons with bipolar I or II disorder, depressed mood state. Primary aim will be to~     assess if brexpiprazole is associated with a reduction in depressive symptom severity using~     the Montgomery-Asberg Depression Rating Scale (MADRS). Secondary aims will include an~     assessment of the following in patients with bipolar disorder taking brexpiprazole: manic~     symptoms, cognition, safety and tolerability of brexpiprazole, and quality of life.~      Subjects will be discontinued from the study if any of the following conditions occurs:~     change in diagnosis to other than bipolar I or II disorder, development of active suicidal or~     homicidal ideation with plan and intent, worsening of mood symptoms, that in the opinion of~     the investigators requires discontinuation, pregnancy, development of severe life-threatening~     medical condition, involuntary psychiatric hospitalization or incarceration.~   "
10614|NCT03427879|"~     The purpose of this investigation is to test the hypothesis that chronic supplementation with~     a dairy-based beverage containing a mixture of blueberry, green tea, and cocoa flavonoids~     (non-nutritive natural plant compounds) will ameliorate exercise-related changes in gut~     permeability and inflammation. In a previous feeding study in humans, (NCT02728570) a high~     flavonoid diet (flavonoids at 340 mg/1000kcal) was effective in mitigating gut permeability~     and inflammation in overweight and obese adults compared to a low flavonoid diet (10mg/1000~     kcal). To test this hypothesis, 20 trained cyclists will complete a randomized crossover~     study with supplementation for 2 weeks with a dairy-based sports beverage containing either a~     high flavonoid (approximately 620 mg) or low flavonoid (approximately 5mg) beverage. After~     the two week intervention, cyclists will complete a 1 hour cycling trial (45 min at 65% VO2~     max then 15 minute time trial). The primary endpoints will be gut permeability as measured by~     plasma intestinal fatty acid binding protein (I-FABP) and the differential sugar test.~     Secondary endpoints will include gut inflammation (measured via fecal calprotectin), plasma~     cytokines (IL-6, IL-10 and TNFα) and plasma LPS. In addition, the distance completed in the~     time trial is a secondary endpoint.~   "
10615|NCT03427866|"~     This research study is studying a drug called Ruxolitinib as a possible treatment for~     Myelofibrosis.~   "
10616|NCT03427853|"~     This is a randomized, double-blind, parallel-group, placebo-controlled, single-dose~     escalation Phase I study to evaluate the safety, tolerability, pharmacokinetics,~     pharmacodynamics and immunogenicity of denosumab injection administered subcutaneously to~     healthy adults in China~   "
10617|NCT03427840|"~     The primary indication for superior hypogastric plexus (SHP) block is visceral pelvic pain,~     most commonly from malignancy of the ovary, uterus, cervix, bladder, rectum or prostate.~     Per-cutaneous SHP blocks should be done under guidance of ultrasonography, fluoroscopy,~     magnetic resonance or computed tomography. During minimally invasive laparoscopic surgery,~     percutaneous technique can be done under the guidance of cameras.~   "
10618|NCT03427827|"~     This trial is aimed to investigate whether adjuvant PD-1 antibody treatment could improve~     survival in locoregionally advanced nasopharyngeal carcinoma.~   "
10619|NCT03427814|"~     This study will enroll subjects with previously-treated advanced or inoperable gastric cancer~     who have responded to first line platinum therapy into two treatment arms. In Arm A subjects~     will receive BGB-290; in Arm B subjects will receive placebo. The purpose of this study is to~     show that BGB-290 (versus placebo) will improve progression-free survival (PFS) in subjects~     with advanced or inoperable gastric cancer.~   "
10620|NCT03427801|"~     An observational study to evaluate the effect of erythropoiesis-stimulating agents in~     treating anaemia of renal disease among adult patients receive palliative care instead of~     dialysis.~   "
10621|NCT03427788|"~     This single center, double-blind, randomized study with up to 11 treatment groups evaluates~     the safety and tolerability, pharmacokinetics, relative bioavailability and food effect of~     single ascending doses of BAY2328065~   "
10622|NCT03427775|"~     Pain management after shoulder surgery remains to be a major challenge. Reliance on a single~     agent (most commonly opioids) results in increased incidence of side effects. Multimodal pain~     management refers to the use of multiple drugs that target different components of pain~     pathway.This proposal aims to measure the quality of recovery and quality of pain management~     after shoulder surgery before and after implementation of a multimodal pain protocol.~   "
10623|NCT03427762|"~     The purpose of the study is to compare the effectiveness and specificity of agility and~     cycling exercise training on balance and mobility outcomes in PD and age and gender matched~     healthy controls. The hypothesis is that due to being profoundly deconditioned, agility and~     cycling will be similarly effective in PD but agility will be more effective then cycling in~     healthy old adults, in improving mobility and balance.~   "
10624|NCT03427749|"~     Patients will be recruited from those referred to the local site's Diagnostic Imaging~     Department for SPECT myocardial perfusion imaging (MPI) ,who have an intermediate to high~     pre-test likelihood of disease (Diamond-Forrester criteria ≥ 30%) and are clinically~     indicated to have an MBF study.~   "
10625|NCT03427736|"~     The purpose of this study is to characterize the pharmacokinetic (PK) and safety profile of~     anesthetics and analgesics in children and adolescents.~   "
11198|NCT03420235|"~     In this study it will be investigate whether a home monitoring program improves~     disease-specific health-related quality of life (HRQOL) for patients with idiopathic~     pulmonary fibrosis (IPF) through appropriate medication use and subsequently results in~     better objective and subjective outcomes.~   "
10626|NCT03427723|"~     Peripheral intravenous cannulation is one of the most common procedures performed in children~     admitted to hospital. It is a painful and anxiety-provoking gesture for children with~     possible memorization of the pain even more present for patients with chronic pathology.~     Nevertheless, this care is essential to administer the treatments.~      The cannulation is usually set up by the observation and touching of the veins by the nurse.~     However, this technique is often insufficient in young children and especially infants~     because they have a higher thickness adipose tissue. Their veins are of small caliber, hardly~     visible and palpable which increases the probability of a failure of the insertion of the~     catheter at the first attempt.~      In the literature, different techniques are mentioned to promote the visualization of veins~     and thus the insertion of cannulation. The AccuVein®400 (AV400) system uses an infrared laser~     beam to project the image of superficial veins to the skin. In adults, AV400 has been shown~     to improve the success rate of insertion cannulation when venous capital is precarious. The~     question now arises as to whether this tool could be of interest to children who are~     particularly difficult to assist cannulation, especially the youngest of them.~      Investigator hypothesize that AV400 could bring a benefit to the placement of cannulation, in~     the child with a venous capital difficult to catheterize and thus increase the success of the~     cannulation at the first attempt.~   "
10627|NCT03427710|"~     The primary objective of the study is to assess pharmacokinetics, dynamics, safety and~     tolerability of CiVi007 following single and multiple subcutaneous doses in subjects,~     including those on statin therapy~   "
10628|NCT03427697|"~     This study evaluates the effect of virtual reality and accommodation relax technique on~     controlling onset and development of myopia in school-aged children. Half of the children~     will receive head-mounted video display which shows video with virtual reality and~     accommodation relax technique in combination, while the other half will receive no~     intervention.~   "
10629|NCT03427684|"~     Gastric cancer is one of the most common malignant tumors in China, and the incidence and~     mortality rate are second in malignant tumors. The treatment of gastric cancer need~     integrated multidisciplinary treatment, and surgery is the only possible curative method for~     gastric cancer at present. Previous studies have reported that neoadjuvant chemoradiotherapy~     can downstage primary tumor to increase radical resection rate in order to improve the~     long-term prognosis of advanced gastric cancer. However, there is no study on the application~     of hypo-radiotherapy to neoadjuvant radiotherapy in gastric cancer. The aim of this study was~     to observe the maximum tolerated dose (MTD) and dose limited toxicity (DLT) of~     hypo-fractionated radiotherapy for locally advanced gastric cancer.~   "
10630|NCT03427671|"~     This is a prospective, open-label, single-arm, safety and effectiveness study of Occlusin 500~     microspheres in women with symptomatic uterine fibroids.~   "
10631|NCT03427658|"~     This study will assess the impact of repeated sweet versus non-sweet food consumption on~     subsequent sweet and non-sweet food preferences and intakes~   "
10632|NCT03427645|"~     The trial is testing an investigator-developed decision support tool for surrogate decision~     makers for stroke patients that are unable to make medical decisions for themselves.~      A historical usual care control group will be enrolled during tool development. The tool will~     then be tested in surrogates of hospitalized stroke patients.~   "
10633|NCT03427632|"~     Percutaneous vertebroplasty is a new technique to strengthen bone and reduce pain for~     patients with vertebral tumors~   "
10634|NCT03427619|"~     Standard of care for Lymphatic Malformations has been surgical excision. We have been using~     OK432/Picibanil (generously supplied by Chugai Pharmaceuticals in Japan) since 1992 with~     great success for macrocystic disease.~   "
10635|NCT03427606|"~     This prospective randomized pilot study is aimed to verify if the operative time of a~     standard laparoscopic sacral colpopexy associated to subtotal hysterectomy for the treatment~     of POP could be further reduced using a continuous locked suture vs. conventional single~     5-points suture for anterior mesh fixation.~   "
10636|NCT03427593|"~     The purpose of this study is to analyse the phenotype in a sub-population of adults with~     severe primary immunodeficiency with lymphoproliferation and neutropenia and to decipher the~     possible pathways involved, especially under the hypothesis of a CTLA4/LRBA schema~   "
10637|NCT03427580|"~     People with schizophrenia spectrum disorders are faced with significant metacognitive~     impairments that include difficulties in their ability to form complex representations of the~     self and others. These impairments are associated with increased symptoms, impaired~     subjective self-experiences, and lower social functioning. As a result, interventions that~     enhance metacognitive capacity have been recently developed and explored. One of these~     interventions is Metacognitive Reflection and Insight Therapy (MERIT; Lysaker et al., 2014).~     MERIT is an integrative model of psychotherapy that seeks to promote holistic metacognitive~     capacity and consequently increase a positive sense of agency and sense of meaning in life~     among clients with schizophrenia. Several case studies (including in Bar-Ilan's community~     clinic), as well as a recent pilot study, showed increased metacognitive abilities and a~     decrease in symptoms following MERIT. The current study will explore both the effectiveness~     and the change mechanisms that underlie MERIT interventon among clients diagnosed with~     schizophrenia spectrum disorders, via both pre- and post-measures of the intervention's~     outcome and session-by-session estimations of the therapeutic process.~   "
10638|NCT03427567|"~     A study to evaluate effectiveness of sublobar dissection in patients with non-small cell lung~     cancer~   "
10639|NCT03427554|"~     Bioequivalence study comparing Tretinoin Cream, 0.1% to RETIN-A®.~   "
10640|NCT03427541|"~     An observational study to explore prognoses and clinical treatments of the patients with~     non-small cell lung cancer complicated with oligometastases~   "
10693|NCT03426852|"~     Sacroiliac joint dysfunction (SJD) is a common problem in individuals with lumbar herniation~     nucleus pulposus (LHNP) plus back pain. It is important to determine the effects of SJD on~     the gait characteristics in individuals with LHNP.Twelve individuals with LHNP (control~     group) and six individuals with LHNP plus SJD (study group) will be the participants of the~     study. Gait characteristics of participants will be evaluate with treadmill. Participants~     will walk at their self-selected speed for six minutes and data from 2nd minutes to 4th~     minutes were selected for statistical analyses. Gait speed, cadance, step lengths, time on~     each foot and step length variabilities will be recorded.~   "
10641|NCT03427528|"~     During this project the investigators will develop and pilot test a companion intervention~     for fathers (Fathers and Babies-FAB), to supplement the Mothers and Babies Course (MB) that~     provides stress and mood management tools for home visiting clients. Focus groups with prior~     study participants, their male partners, and home visiting staff will be used to develop the~     FAB curriculum and protocol. FAB text messages aim to improve the mental health of the male~     partner and help him support his partner's mental health. Feasibility, acceptability, and~     outcome measures will be supplemented with assessments of fathers' mental health and~     partners' relationships. Participant assessments will be conducted at baseline, 3 and 6~     months in this uncontrolled pilot study. The public health significance and innovation of~     this project is substantial. If the investigators are able to integrate MB-TXT and MB-DAD~     into home visiting programs and generate improved mental health outcomes for home visiting~     clients and their partners, the investigators will be prepared to replicate this intervention~     across home visiting programs nationally at a time when home visitation as a service delivery~     model for families with infants and young children is rapidly proliferating through federal~     funding.~   "
10642|NCT03427515|"~     Probiotics are live microorganisms exhibiting multiple properties beneficial to health. An~     increasing body of evidence indicates that probiotics may support healthy brain function and~     may relieve stress. Recent research in this area has examined lactic acid bacteria in detail,~     but little is known about the stress-relieving effects of Saccharomyces, a yeast with~     probiotic properties.~      Psychological stress is a factor that allows people to successfully cope with various daily~     life situations. On the other hand, excessive stress may lead to bodily harm and decrease~     performance, e.g. academic achievements. Probiotics may help manage stress, but little is~     known whether probiotics improve performance under stress.~      The aim of this trial is to examine whether the healthy medical students may demonstrate~     better performance in academic examinations when supplementing their diet with a yeast~     probiotic strain Saccharomyces boulardii (CNCM I-1079) or bacterial probiotic strain~     Lactobacillus rhamnosus GG (ATCC 53103). The secondary aim of the trial is to evaluate the~     potential effects of this supplementation on state anxiety as well as on biochemical and~     physiological stress markers.~   "
10643|NCT03427502|"~     Postoperative agitation is an important complication of general anesthesia, moreover, it has~     been found with high incidence in ear, nose, throat (ENT) surgeries. We aim to study whether~     anterior ethmoidal nerve block will be successful in reducing postoperative agitation in~     those patients. Study population will be randomized into two groups, treatment and control~     group. Anterior ethmoidal nerve block will be done in treatment group and postoperative~     agitation compared between these two groups. Agitation score will be scored with Riker~     Sedation-Agitation Scale (SAS).~      Ho: Occurrence of post-operative agitation in patients undergoing nasal surgery with nasal~     pack under general anesthesia is equal in those with ethmoidal nerve block as compared to~     those without the block.~      Ha: Occurrence of post-operative agitation in patients undergoing nasal surgery with nasal~     pack under general anesthesia is not equal in those with ethmoidal nerve block as compared to~     those without the block.~   "
10644|NCT03427489|"~     Coronary heart disease (CHD) poses a major health burden in the Gulf countries. It is the~     leading cause of mortality and morbidity in the world and poses an enormous societal burden~     in the Gulf countries. Early detection of disease is imperative to reduce the health care~     burden and financial costs associated with CHD. Knowledge of novel genetic and proteomic~     markers of CHD will provide more precise estimates of risk while defining the pathways~     important in individual patients, revealing new targets for intervention, and ultimately~     enabling an individualized approach to care.~      To translate recent advances in genomics and proteomics into clinical practice, these newly~     discovered biomarkers will need to be evaluated in patients of diverse ethnic groups with~     varying characteristics, environmental factors, and medication use. The investigators propose~     to establish a biorepository of plasma and Deoxyribonucleic acid (DNA) linked to demographic~     and clinical variables to facilitate biomarker studies of CHD risk, progression, and outcome.~     The overarching goal in developing the Qatar Cardiovascular Biorepository (QCBio) is to~     create a resource that fosters research aimed at identifying novel biochemical and genetic~     markers of CHD. A biorepository with linkage to clinical data will also provide an invaluable~     resource for cardiovascular research, including genomic and proteomic studies of CHD and~     development of biomarkers for early detection of disease and personalized drug therapy~     (pharmacogenetics and pharmacoproteomics).~   "
10645|NCT03427476|"~     The purpose of this study is to test a novel diagnostic PET imaging agent for safety and~     biodistribution. The agent binds PSMA and is designed to detect Prostate Specific Membrane~     Antigen expressing tumors, such as has been described for some renal cell carcinoma tumors.~   "
10646|NCT03427463|"~     The purpose of this study is to determine the ideal dose of spinal morphine for use in~     Cesarean section. Spinal anesthesia (single injection in the lower back to numb patients from~     the waist down) is commonly used in Cesarean section to provide numbness and pain relief~     during the surgery, and adding morphine to the spinal anesthetic provides long lasting pain~     relief for up to 24 hours after surgery. The ideal dose of spinal morphine, when given with~     other types of pain medications such as nonsteroidal anti-inflammatories and acetaminophen,~     has not been determined. In addition, spinal morphine can have side effects such as nausea~     and itching, so using a lower dose of morphine may decrease these side effects while~     providing the same amount of postoperative pain relief. Study participants will be divided~     into two groups. Group 1 will receive the standard dose of spinal morphine (0.1mg) while~     Group 2 will receive a lower dose of spinal morphine (0.05mg). Both groups will receive the~     standard dose of spinal bupivacaine (numbing medication) and spinal fentanyl (short acting~     pain medication). The additional pain medications (IV Toradol and oral acetaminophen) will be~     given to both groups after surgery. Pain control and morphine side effects will be compared~     between the two groups in order to determine the best dose of spinal morphine for cesarean~     section.~   "
10705|NCT03426696|"~     The purpose of this study is to evaluate the psychological status of Thyroid Related Eye~     Disease.~   "
10931|NCT03423758|"~     There is increasing evidence that there are genetic risk factors for several forms of~     glaucoma, such as glaucoma caused by pseudoexfoliation syndrome (PXF) and primary angle~     closure glaucoma (PACG). The aim of the present prospective, multi-center, case-control study~     is to identify susceptibility genes/loci for PXF and PACG using a whole genome association~     (WGA) approach.~   "
10648|NCT03427437|"~     Caudal epidural block has been widely used, especially in pediatric surgery, to supply~     intraoperative and postoperative analgesia by affecting the region between T10 and S5~     dermatomes in surgeries below the umbilical level.~      In conventional single-shot caudal block, the needle is inserted through the skin with a~     60-80 degrees angle, until the sacrococcygeal ligament is passed through. Then the angle of~     the needle is decreased to 20-30 degrees and inserted further for an additional 2-3 mm,~     entering into the sacral canal.There is a risk of dural or vascular puncture when the needle~     is passing through sacral canal. Other complications are the soft tissue bulging,~     intraosseous injections and systemic toxicity.~      Many anatomical variations have been reported for sacral hiatus and sacral cornua. Therefore,~     the success rate of the classic caudal epidural anesthesia method in pediatric patients has~     been reported to be about 75%.~      With the usage of ultrasonography in regional anesthesia, many advantages have been reported.~     In particular ultrasonography under longitudinal image is helpful for visualization of the~     sacral hiatus, sacrococcygeal ligament, duramater, epidural space and the distribution of the~     local anesthetic agent Therefore, this significantly increases the block success and~     visualization of where local anesthetic is injected.~      The primary aim of this study was compare the success rate of ultrasound guided sacral hiatus~     injection and conventional sacral canal injection. Secondary objectives are; block performing~     time, number of needle puncture, success at first puncture and complication rate. However age~     and weight encountered wtih these complications are registered.~   "
10649|NCT03427424|"~     Background:~      Many people suffer from drug addiction. But currently, treatments are not very effective. One~     group of patients in this study are enrolled in addiction treatment through physician health~     programs (PHPs). About 70% of these patients are able to stop using drugs for extended~     periods of time. By studying this specific group of patients, researchers want to understand~     the difference between those who may or may not respond to treatment. They want to study the~     brain while people do thinking and feeling tasks and when they relax. They will study brain~     chemicals, a stress hormone, and certain genes. The results may help them understand the~     brain basis for addiction and recovery.~      Objectives:~      To use brain imaging to find differences between people with and without drug addiction. To~     see if these differences help predict addiction.~      Eligibility:~      Healthy, right-handed adults ages 25 65, enrolled in a physician health program or those with~     no history of addiction and with at least 16 years of education~      Design:~      Participants enrolled in a PHP will be screened under this study and participants with no~     history of addiction will be screened under another study.~      At the study visit, participants will:~      Have a routine check-up, including tests for pregnancy, drugs, and alcohol.~      Give 11 blood samples.~      Rate their cravings.~      Test their frustration with stressful situations by responding to questions on a screen.~      Practice the magnetic resonance imaging (MRI) tasks:~      Shock task. Two electrodes placed on a foot will deliver brief, low-strength electrical~     shocks that get gradually stronger, but not painful. Participants will see drug or neutral~     images. They will rate their discomfort.~      Thinking tasks. Participants will answer questions about pictures, numbers, and money. They~     will press buttons in response to things they see.~      Do the MRI tasks in 2 sessions (morning and afternoon) in the scanner. Participants will lie~     in an MRI machine which will take pictures of the brain while doing these tasks.~      Some participants will repeat the visit twice over a year at set intervals.~      Meals will be provided, and visits will include meal breaks and smoking breaks for those who~     smoke.~   "
10650|NCT03427411|"~     Background:~      In the United States, each year there are more than 30,000 cases of human papillomavirus~     (HPV) associated cancers. Some of these cancers are often incurable and are not improved by~     standard therapies. Researchers want to see if a new drug M7824, which targets and blocks a~     pathway that prevents the immune system from effectively fighting the cancer can shrink~     tumors in people with some HPV cancers.~      Objectives:~      To see if the drug M7824 causes tumors to shrink.~      Eligibility:~      Adults age 18 and older who have a cancer associated with HPV infection.~      Design:~      Participants will be screened with medical history and physical exam. They will review their~     symptoms and how they perform normal activities. They will have body scans. They will give~     blood and urine samples. They will have a sample of their tumor tissue taken if one is not~     available.~      Participants will have an electrocardiogram to evaluate their heart. Then they will get the~     study drug through a thin tube in an arm vein.~      Participants will get the drug every 2 weeks for 26 times (1 year). This is 1 course.~      After the course, participants will be monitored but will not take the study drug. If their~     condition gets worse, they will start another course with the drug. This process can be~     repeated as many times as needed.~      Treatment will stop if the participant has bad side effects or the drug stops working.~      Throughout the study, participants will repeat some or all the screening tests.~      After participants stop taking the drug, they will have a follow-up visit and repeat some~     screening tests. They will get periodic follow-up phone calls.~   "
10651|NCT03427398|"~     This phase II trial studies how well ibrutinib works in treating patients with stage IV~     melanoma of the skin that has not responded to previous treatment. Ibrutinib may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
10652|NCT03427385|"~     The purpose of this study is to determine the minimum dose of ropivacaine 0.5%, required to~     produce pain relief without weakening the leg muscles.~   "
10653|NCT03427372|"~     To investigate the effect of patient mood and cigarette smoking before spinal anesthesia on~     post spinal puncture headache and backache~   "
10654|NCT03427359|"~     To prospectively evaluate the short-term efficacy and toxicity of induction chemotherapy with~     cisplatin and capecitabine followed by concurrent chemoradiotherapy (CCRT) in the treatment~     of locally advanced nasopharyngeal carcinoma.~   "
10655|NCT03427346|"~     The study will compare EMR versus ESD technique (both combined with subsequent ablative~     therapy) of mucosal resection in Barrett's esophagus with regard to efficacy and risk in a~     long term setting.~   "
10656|NCT03427333|"~     The purpose of this study is to confirm the efficacy and safety of the Talon Surgical Rook®~     Epicardial Access Kit as a pericardial access device. The Rook® Epicardial Access Kit will be~     used to gain access the epicardial surface of the heart via a subxiphoid approach in adult~     patients with a normal, non-distended pericardial space.~   "
10729|NCT03426384|"~     The first phase of this pilot study will assess changes in quality of life at the end of a~     16-week Mymee program in patients with moderate to severe SLE. The second phase will assess~     changes in healthcare utilization and cost over a one year period after program end.~   "
10730|NCT03426371|"~     The study is an double blind, randomized, multicenter phase 3 trial. The efficacy analyses~     are based on 570 Chinese patients with RAS wt mCRC treated with mFOLFOX-6 ± cetuximab. Study~     treatment continues until disease progression or unacceptable toxicity (ie, not for a fixed~     number of courses). The primary endpoint of the study is progression-free survival (PFS) time~     according to RECIST 1.0; key secondary endpoints include overall survival (OS) time, overall~     response rate (ORR), and safety/tolerability.~   "
10657|NCT03427320|"~     Hypoxic cells in tumors have less oxygen than normal cells do, which leads to several changes~     inside the cells that lead to genetic chages making these cells resistant to treatment. The~     end result of this is increased tumor growth, spread of the tumor and poor outcome. Early~     studies have shown that [131]I-IAZA scans can help detect if there are hypoxic cells in the~     tumor. A [131]I-IAZA scan is a nuclear medicine test used to create pictures of the whole~     body after [131]I-IAZA is injected into a vein. Further scientific research will help~     understand how [131]I-IAZA is distributed throughout the body and how it can be used to treat~     hypoxic tumor cells.~      The purpose of this study is to :~        1. Demonstrate the safety of [131]I-IAZA~        2. To Determine the biodistribution and tumor avidity of [131]I-IAZA in patients with~          locally advanced or metastatic solid tumors.~        3. To determine the optimal imaging time of [131]I-IAZA SPECT.~        4. To collect data from imaging and plasma sampling for radiopharmacokinetic analysis of~          [131]I-IAZA.~        5. To determine whole body dosimetry of [131]I-IAZA in selected patients.~        6. To evaluate tumor dosimetry of [131]I-IAZA in patients with positive uptake.~        7. To determine the radiation dose accrued in hypoxic tumors.~   "
10658|NCT03427307|"~     Background In hemodialysis (HD) patients, impaired gut barrier and alteration in microbiota~     in the gut is thought to increase the risk of bacterial translocation and chronic~     inflammation. Lipopolysaccharide-binding protein (LBP) is an acute-phase reactant that~     mediates immune responses triggered by microbial products. Our aim is to investigate the~     relationship between circulating levels of LBP, inflammatory markers and incident~     atherosclerotic vascular events in HD patients and follow-up this defined cohort for 3 years.~      Methods A total of 300 HD patients will be recruited. The LBP and inflammatory markers will~     be determined using immuoassay methods annually. A bioimpedance spectroscopy device will used~     for body fat composition measurement and measurements will be done annually. Arterial~     stiffness is evaluated by measuring PWV in the heart-femoral segment using an automatic~     waveform analyzer.~   "
10659|NCT03427294|"~     Delphi study on perioperative rehabilitation after single level lumbar arthrodesis.~   "
10660|NCT03427281|"~     A variety of postoperative bracing are routinely applied after spinal procedures but there~     are limited data regarding their efficacy, especially with the increasing use of internal~     fixation.Currently, no data are available regarding the use of postoperative braces in~     Belgium. Bracing is sometimes considered after lumbar surgery for degenerative conditions.~     All neurosurgeons and orthopedical surgeons in Belgium will be questioned to assess the~     patterns of postoperative bracing use after lumbar surgery.~   "
10661|NCT03427268|"~     This trial will evaluate the efficacy of PM060184 in terms of progression-free survival at 12~     weeks (PFS3) in advanced or metastatic Colorectal Cancer (CRC) patients with any KRAS~     mutation status (wild- type; mutated; or unknown status) progressing after standard~     treatments (fluoropyrimidine, irinotecan, and oxaliplatin).~      Patients in this trial will receive PM060184 at a dose of 9.3 mg/m2 as a 30-minute~     intravenous (i.v.) infusion on Days 1 and 8 q3wk.~   "
10662|NCT03427255|"~     The current study will employ a group CBT treatment program of 10 group sessions and 3~     individual couple sessions targeting the thoughts, emotions, behaviors and couple~     interactions associated with the experience of dyspareunia. Women with superficial~     dyspareunia and their partners will be randomized to the CBT group program-plus or a waiting~     list control period at one treatment location in Sweden and two treatment locations in the~     Netherlands. The waiting-list control period will be comparable to the treatment duration of~     six months.~      It is hypothesized that the group program-plus is more effective in improving pain during~     intercourse in women with superficial dyspareunia compared to women on a waiting-list control~     period.~   "
10663|NCT03427242|"~     This is a phase II open-label, one-arm, single-center study of apatinib for eligible patients~     with advanced biliary tract carcinoma after the first-line treatment failure. A total of 55~     patients is planned for enrollment. The time for enrollment is from Nov 2017 to Nov 2020, the~     the follow-up will be ended after Nov 2021. Patients in the study would receive oral apatinib~     500-750mg qd until progression of disease.~   "
10664|NCT03427229|"~     Fecal microbiota transplantation (FMT) is acknowledged as a highly effective treatment for~     recurrent Clostridium difficile infection (CDI). Usually single fecal infusion achieves~     satisfactory cure rates of recurrent CDI). However, several retrospective studies show that~     severe clinical picture of recurrent CDI is a risk factor for the failure of single-infusion~     FMT, suggesting that multiple fecal infusions are required to cure this condition.~      This is an open-label randomized clinical trial aiming to assess if multiple-infusion FMT is~     more effective than single-infusion FMT in curing severe CDI~   "
10665|NCT03427216|"~     This study is a randomized, placebo controlled double blind cross over trial. Patients~     presenting with pelvic floor myalgia will be asked to complete a series of standardized~     questionnaires to assess their pain, quality of life and sexual function and satisfaction.~     They will be randomized to either a treatment group or placebo group and will use the~     supplied suppositories once daily for 2 months. They will then undergo a one month washout~     after which they will be placed in the cross over group for a second two months of treatment.~      Primary outcome measure: change in Visual Analogue Scale for Pain (VAS-P) scores before and~     after treatment Secondary outcome measures: change in Female Sexual Function Index (FSFI),~     Patient Global Impression of Improvement (PGI-I), and Short Form Health Survey (SF-12) before~     and after treatment~   "
10666|NCT03427203|"~     The study investigates the performance of three new adhesives with regard to leakage and the~     skin condition.~   "
10667|NCT03427190|"~     In France, suicide behaviours are a major public health concern that triggered the creation~     in 2013 of a National Observatory of Suicide. In continental France, the Algos protocol was~     found to be effective for the prevention of suicide attempts reiterations. This protocol is~     based on a procedure that keeps telephone and postal contacts with the suicide attempter and~     allows, via an algorithm, to assess the risk of suicide attempt recurrence, in order to~     intervene if necessary. Nevertheless, Algos does not involve primary care health~     practitioners, who could add a substantial additional efficacy, especially if they intervene~     downstream and in supplement to Algos. In addition, this kind of protocol has never been~     evaluated in the French overseas territories.~   "
11199|NCT03420222|"~     This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate AVP-786~     for the treatment of Intermittent Explosive Disorder (IED).~   "
10668|NCT03427177|"~     Investigators aim to test a culturally diverse and patient guided mHealth decision tool~     called mychoice, which allows patients to explore their concerns and questions related to~     clinical trial participation, as well as create a customized and personalized set of~     questions to enhance patient-provider communication and increase informed decision making.~     This study employs a mixed-methods approach using both qualitative and quantitative data to~     evaluate the effectiveness of the mychoice intervention for patients and to explore the~     provider and organizational factors that impact implementation. A randomized controlled trial~     will be performed with 200 participants in order to determine the acceptability and~     feasibility of the intervention, as well as its effects on self-efficacy in discussing~     clinical trial participation with providers, leading to enhanced informed decision-making.~     Results will also investigate whether the tool has enhanced effects on minority patients,~     particularly African Americans. A secondary aim of the study is to evaluate the~     implementation of the intervention in clinical settings. Implementation evaluation will occur~     using surveys of medical staff whose patients are participating in the study. These surveys~     will assess institutional facilitators and barriers to study implementation. Investigators~     will also conduct cognitive de-briefing interviews after the intervention is completed with~     key stakeholders at the participating institutions, which will inform a larger implementation~     study in the future.~   "
10669|NCT03427164|"~     The primary purpose of this project is to determine if acute monitoring of shunt patency via~     ultrasound elastography measurements of splenic stiffness before and after TIPS placement~     results in reduced morbidity and mortality from shunt failure.~   "
10670|NCT03427151|"~     this study extension objective is to evaluate the safety and tolerability of a 200-mcg dose~     every 4 weeks for 24 weeks of IPP-201101 in patients with active systemic lupus erythematosus~     (SLE) who had participated in the main study IP-005.~   "
10671|NCT03427138|"~     The aim of the study is to determine whether a targeted behavioral intervention can lead to~     both changes in early communication skills and in neural responses in toddlers and~     preschoolers with autism.~   "
10672|NCT03427125|"~     This Phase 3, 26-week, open label study with a 12-week, placebo-controlled, randomized~     withdrawal period followed by an open label long term safety extension will evaluate the~     safety and efficacy of tenapanor to treat hyperphosphatemia in end-stage renal disease (ESRD)~     on hemodialysis and peritoneal dialysis.~   "
10673|NCT03427112|"~     Xin1 Humerus system is an X-ray-based tracking and navigation system designed to calculate~     the plate position and all required proximal screw lengths for proximal humerus plate~     fixation. The aim is to validate the system performance in a clinical context and test the~     surgical handling of the Xin1 marker in a hospital environment. 10 adults having sustained a~     proximal humerus fracture and are indicated for plate fixation osteosynthesis will be~     provided intraoperatively with the Xin1 marker. The system performance is evaluated~     retrospectively by post-processing the intraoperative X-ray images after surgery~   "
10674|NCT03427099|"~     To compare the current rehabilitation pathway with the implementation of a newly developed~     rehabilitation pathway for patients with a single level lumbar arthrodesis.~   "
10675|NCT03427086|"~     This is a randomized double blinded randomized 2:1 study. The duration of the study is 6~     month. The safety and tolerability of high doses of biotin (300 mg/ day) will be compared to~     placebo in patients with amyotrophic lateral sclerosis. Patients will be evaluated at~     baseline, 3, and 6 month. The primary outcome will be any adverse effects recorded. The~     secondary outcomes will be motor disability measured by ALS-FRS, change in Pulmonary function~     test parameters (FEV1- FVC), change in subject weight (in kg).~   "
10676|NCT03427073|"~     ALM201 is a peptide with anti-angiogenic activity in a range of in-vitro and ex-vivo models.~     ALM201/0001 is a Phase 1, open-label, dose escalation study of the safety, tolerability and~     pharmacokinetics (PK) of ALM201. The study is divided into two parts. In Part 1, patients~     with advanced solid tumours will receive daily doses of ALM201 on Days 1-5, 8-12 and 15-19 in~     21 day cycles to assess the safety profile of ALM201. Part 2 will be a dose expansion of the~     Maximum Tolerated Dose (MTD) determined in Part 1. Patients with advanced ovarian cancer will~     be enrolled with the main objective to determine the recommended Phase 2 dose.~   "
10677|NCT03427060|"~     Coversin in Paroxysmal Nocturnal Hemoglobinuria (PNH) in patients with resistance to~     Eculizumab due to complement C5 polymorphisms.~   "
10678|NCT03427047|"~     Randomized study comparing surgical and economic parameter of Total Knee Arthroplasty~     performed using two different specific surgical techniques.~   "
10679|NCT03427034|"~     Is BladderLight® (BL) urine testing accurate, as a non-invasive method, to exclude presence~     of bladder cancer in patients.~   "
10680|NCT03427021|"~     The main purpose of this study is to evaluate whether exposure to ice chips in the mouth~     (oral ice chips) during oxaliplatin treatment prevents or reduces symptoms of cold~     sensitivity.~   "
10681|NCT03427008|"~     The investigators are interested in whether or not the use of a mobile health (mHealth)~     application increases the rate of immunosuppression medication adherence among adult kidney~     transplant recipients. The investigators aim to test this by randomly assigning transplant~     recipients to the intervention (use of an mHealth app to manage and track their~     immunosuppression regimen) or control arm (standard of care) upon discharge from their~     initial transplant hospitalization, and tracking medication adherence over time. The study~     population will be approximately 50 adult kidney transplant recipients at the Johns Hopkins~     Hospital.~   "
10691|NCT03426878|"~     The CHARM (Cancer Health Assessment Reaching Many) study will assess the utility of clinical~     exome sequencing and how it affects care in diverse populations. The study population~     includes adults at risk for hereditary cancer syndromes.~      The primary objective is to implement a hereditary cancer risk assessment program in healthy~     18-50 year-olds in primary care settings within a vertically integrated health delivery~     system (Kaiser Permanente) and a federal qualified health center (Denver Health). The~     investigators will assess clinical exome sequencing implementation and interpretation, as~     well as tailored interactions for low health literacy including a contextualized consent~     process, and a modified approach to results disclosure and genetic counseling. The~     investigators will also assess the clinical utility (healthcare utilization and adherence to~     recommended care) and personal utility of primary and additional results from clinical exome~     sequencing, and evaluate the ethical and policy implications of considering personal utility~     of genomic information decisions for health care coverage.~   "
10682|NCT03426995|"~     This FTIH study, intends to identify the doses of GSK3358699, which are well tolerated by the~     subjects whilst delivering a robust pharmacodynamic (PD) response. This study will evaluate~     the safety, tolerability, pharmacokinetic (PK) and PD profile of single (in both fed and~     fasted states) and multiple ascending doses of GSK3358699 in healthy male subjects within a~     pre-defined and controlled pharmacodynamic and pharmacokinetic range for each cohort. It also~     intends to understand the effect of GSK3358699 on systemic markers of inflammation following~     low dose in vivo lipopolysaccharide (LPS) or Granulocyte-Macrophage Colony-Stimulating Factor~     (GM-CSF) challenge and local inflammation in cantharidin-induced blisters. The study has been~     carefully designed to explore the in vivo biology of the target and the potential for the~     study drug to become a transformative medicine for subjects in multiple immuno-inflammatory~     disease indications.The study will be conducted in three Parts. Total duration for~     participation will be approximately 23 weeks for Part A, 9 weeks for Part B and 12 weeks for~     Part C. The study will be conducted in up to 80 subjects.~   "
10683|NCT03426982|"~     Background:~      Unfractionated heparin (UFH) is a sulfated polysaccharide extracted from porcine intestinal~     mucosa that enhances the inhibitory activity of the natural anticoagulant antithrombin~     towards most activated clotting factors (F), particularly FXa and FIIa (thrombin) . Despite~     the growing interest for low molecular weight derivatives (LMWH), UFH is still widely used~     for different indications including the treatment of acute thrombosis including venous~     thromboembolism, coronary syndromes (ACS), and other thrombotic diseases. UFH is administered~     by parenteral route either intravenous (IV) or sub-cutaneous (SC).Actually, there is evidence~     that the risk of recurrence of thrombosis is increased when heparin levels fells below the~     lower limit of the therapeutic range, while the hemorrhagic risk increases with heparin~     levels above the upper limit of the therapeutic range. Moreover, the anticoagulant response~     to UFH is highly variable for one individual to another. As the clinical efficacy of heparin~     is dependent on maintaining an anticoagulant effect above a minimum level, careful laboratory~     monitoring of UFH treatment is mandatory. For that purpose, two options are offered to the~     clinicians: i) to evaluate either the prolongation of a global clotting assay, the activated~     partial thromboplastin time (aPTT) and ii) to measure the heparin-enhanced inhibitory~     activity of AT toward purified activated factors such as FIIa and FXa using chromogenic~     substrate-based assays. UFH therapy is still widely monitored by the aPTT, a global clotting~     assay, that reflects the ability of heparin to enhance the inhibitory activity of AT against~     FIIa, FXa, and other activated factors. The therapeutic range of aPTT prolongation is highly~     dependent on the reagent and analyzer used. As the consequence, it must be defined by each~     laboratory in its own technical conditions (for each reagent batch) to correlate with heparin~     levels between 0.20 and 0.40 U/mL (protamine sulfate titration), corresponding to anti-FXa~     activity between 0.30 and 0.70 IU/mL. In that connection, the prolongation of aPTT~     corresponding to antiFXa activity between 0.30 - 0.70 IU/mL is highly variable depending of~     the reagents e.g.between 1.6 - 2.7 x control for weakly sensitive reagents and between 3.7 -~     6.2 x control for highly sensitive reagents. The use of aPTT has advantages as it is~     easy-to-perform, quick, inexpensive but faces numerous challenges due to the significant~     influence of the technical conditions (reagent/instrument) on the test result, to lot-lot~     variation in reagent sensitivity, to the need of studies to evaluate the therapeutic range,~     to limited therapeutic range, and also to non-specific prolongation in the case of lupus~     anticoagulant, factors deficiency, inhibitors or shortening in the case of high factor~     levels, particularly FVIII.In contrast, the use of chromogenic anti-Xa assays has many~     advantages particularly a published therapeutic range for UFH i.e. between 0.30 and 0.70~     IU/mL, a specificity to its interaction with AT (no Heparin Cofactor II interference by using~     bovine FIIa or short incubation time) and faces few challenges such as limited availability~     in some area and a cost that is slightly higher than that of aPTT. In addition, anti-Xa~     assays allow accurate measurement of all heparin(s) derivatives and particularly LMWHs and~     fondaparinux.~      Since the first reports in the mid-eighties, some small sized studies have compared the two~     monitoring strategies mainly retrospectively designed (7-11). Even though, one single~     prospective randomized management study evaluated the comparison between the two monitoring~     strategies with clinical end-points i.e. recurrence of thrombosis and bleeding complication~     in a cohort of 131 patients with VTE . All concluded to a trend toward higher, or at least~     similar, safety/efficacy/efficiency when patients were monitored using antiXa activity vs.~     aPTT. Even though differences were not significant due to the lack of power of these studies.~   "
10684|NCT03426969|"~     The goal of this clinical research study is to learn about the safety of giving a stem cell~     transplant from a tissue-mismatched (haploidentical) donor, followed by cyclophosphamide, to~     patients with advanced myelofibrosis (MF). Melphalan, fludarabine, and total body irradiation~     (TBI) will also be given before the transplant as part of your standard care.~      In this study, researchers also want to learn if cyclophosphamide can help to prevent~     graft-versus-host disease (GVHD -- when transplanted immune tissue, such as the donor's~     tissue, attacks the tissues of the recipient's body).~      This is an investigational study. All of the drugs, including TBI, used in this study are FDA~     approved and commercially available for the treatment of MF. It is considered part of your~     standard care. However, it is investigational to use a haploidentical donor in patients with~     myelofibrosis.~      The study doctor can explain how the study drugs are designed to work.~      Up to 12 participants will be enrolled in this study. All will take part at MD Anderson.~   "
10685|NCT03426956|"~     To investigate the impact of canagliflozin on secretion of gut hormones, in particular~     glucagon-like peptide 1 (GLP-1) in gastric bypass operated patients.~   "
10686|NCT03426943|"~     Sepsis is a major cause of death in Intensive Care Units and therefore finding new therapies~     to improve survival rates and limit morbidity is a major goal. Over the past decades, blood~     purification has been proposed as an adjuvant therapy for sepsis. The goal of blood~     purification is to restore the immune homeostasis and efficiency through the removal of~     bacterial products including endotoxins, broad-spectrum cytokines and other inflammatory~     mediators. Indeed, the large and overwhelmed release of these mediators in the early phase of~     sepsis may induce multiple organ failure syndrome. In 2017, different techniques are proposed~     for blood purification. Among them, the highly adsorptive membrane, oXiris™, seems promising.~     This membrane can be used in case of Acute Kidney Injury associated with sepsis and exhibits~     enhanced blood purification capacities. Previous studies on animals have already proven that~     this membrane can remove broad-spectrum cytokines but also endotoxins from the blood. This~     ability to remove endotoxins is particularly interesting since endotoxins are believed to be~     the trigger of the immune cascade at the initiation of sepsis.~      The lack of clinical evidence is the main limit to a wider use of this membrane. Therefore,~     the aim of the present clinical trial is to characterize the blood purification properties of~     the membrane in a human clinical setting. The oXiris™ membrane is specifically designed to~     improve the adsorptive capacities of the polyacrylonitrile-based AN69 membrane. Its extremely~     rich coating of polyethyleneimine (PEI) gives the membrane the ability to bind and remove not~     only cytokines but also endotoxins due to the positive charges of PEI at the surface of the~     membrane. The tested hypothesis is that the oXiris™ filter allows for a greater endotoxin and~     cytokine removal compared to a standard polysulfone (PrismafleX HF1400) filter in patients~     with septic shock.~   "
10687|NCT03426930|"~     Anorexia nervosa is an eating disorder that begins frequently in adolescence between the ages~     of 13 and 19, which affects girls with a sex ratio of 10:1, and the prevalence for females~     varies from 0,3% to 0,9%.~      The current therapeutic arsenal has a limited success in the treatment of anorexia nervosa~     with a long-term mortality rate and a 12-month relapse rate of up to 10% and 40%,~     respectively.~      One of the most difficult symptoms to treat is a body dysmorphic disorder, also called~     dysmorphophobia, the persistence of this symptom is a major negative prognostic factor.~      The main treatment of dysmorphophobia is currently cognitive behavioral therapy (CBT). In~     most protocols, the technique of progressive exposure face to the mirror is used with low~     efficiency. Adapted physical activity has recently been proposed in the literature as a tool~     to improve body perception.~      Face of complex management of this major symptom that is dysmorphophobia, some offer to use~     virtual reality.~      It is in this context that the study proposes to study the contribution of virtual reality in~     the treatment of the body dysmorphic disorder of adolescent patients hospitalized for~     anorexia nervosa in the department of Child and Adolescent Psychiatry Salvator Hospital in~     Marseille.~      It will be compare the importance and the evolution of the dysmorphophobia between two groups~     of teenagers hospitalized in Space Arthur for anorexia nervosa: an experimental group~     receiving the treatment with the contribution of the virtual reality, and a control group~     receiving the reference treatment of dysmorphophobia used in our unit.~      It will be recruit 30 adolescent females with anorexia nervosa according to the diagnostic~     criteria of Diagnostic and Statistical Manual of Mental Disorders (DSM)-5. The subjects will~     be divided into 2 groups of 15 teenagers, according to a randomization list, a group with a~     classic protocol, a group with virtual reality. The subjects with virtual reality will have 5~     exposure sessions where they will be able to model their body in view in 1st person and 3rd~     person, via an Oculus Rift. It will be compare the following parameters: the different scores~     related to dysmorphophobia according to different questionnaires, the self-evaluation of the~     Body Mass Index (BMI), in order to observe the evolution of the symptom, then the anxiety~     relative to the exposure of a BMI higher in order to work the fear of getting fat, the choice~     of the most pleasant BMI, to evaluate skinny body addiction.~      At the end of the study, we hope to highlight the effectiveness of virtual reality to fight~     against dysmorphophobia, in order to have a better estimate of its body aspect, and to impact~     the evolution towards the cure in anorexia nervosa in teenage girls. In addition to~     increasing our knowledge, this could allow to consider new strategies in the management of~     anorexia nervosa, and why not democratize more virtual reality with adolescents followed in~     child and adolescent psychiatry.~   "
10688|NCT03426917|"~     Retrospective descriptive study~   "
10689|NCT03426904|"~     The main cause of recurrence after surgical treatment of colon cancer is distant metastasis.~     Neoadjuvant chemotherapy has potential benefits of improving the effectiveness of~     chemotherapy. Preoperative chemotherapy may eradicate microscopic metastatic cancer cells~     earlier than adjuvant chemotherapy, reduce cancer cell spillage during surgery, and lessen~     the invasiveness of surgical resection. This randomized multicenter phase III trial is~     assessing whether preoperative chemotherapy improves oncologic outcomes of patients with~     locally advanced colon cancer.~   "
10690|NCT03426891|"~     The purpose of this research study is to test the safety and tolerability of the combination~     treatment of the investigational drugs vorinostat and pembrolizumab, in combination with~     chemotherapy (temozolomide), and radiotherapy. The U.S. Food and Drug Administration (FDA)~     has approved pembrolizumab for use to treat a deadly skin cancer called melanoma and lung~     cancer and vorinostat to treat some forms of blood and lymph node cancers. However, both~     vorinostat and pembrolizumab are considered investigational drugs in this study because they~     are not approved for treatment of glioblastoma.~   "
10692|NCT03426865|"~     Investigators will use Axumin PET/CT to help with the imaging modalities to determine the~     presence of occult retroperitoneal disease.~   "
13247|NCT03393455|"~     More and more parents decide to maintain pregnancy which could have been interrupted because~     of serious fetal pathologies.~      In this observational study, we examine obstetrical and pediatric evolution of these~     pregnancies, from 2006 to 2016 in Montpellier University Hospital.~   "
10694|NCT03426839|"~     Comparative study on efficacy of haemostatic therapy guided either by standard laboratory~     coagulation parameters or point-of-care testing in patients undergoing vascular surgical~     procedures. We investigate the amount of perioperative bleeding and the number of blood~     product used.~      Inclusion criteria Patients scheduled for elective and acute open aorta surgery or undergoing~     acute aorta surgery with minimally invasive techniques and were provided treatment in the~     operating theatre and/or ICU attached to perioperative care, they must be at least 18 years~     of age and written informed consent was obtained from the patient or his/her legal~     representative.~      Randomisation technique Patients will be randomly assigned to each of two treatment groups~     using sealed envelopes. In group 1 (G1) haemostasis strategy guided by conventional~     coagulation tests, while in group 2 (G2) transfusion algorithms guided by point-of-care (POC)~     tests will be carried out.~      Sampling techniques and measurements~      For assessment of monitored parameters shall be used arterial or venous blood depending on~     the catheter placed preoperatively. In case of the above mentioned vascular surgical~     procedures, all patients will receive arterial cannula routinely, and, depending on the~     extension of procedure, as appropriate, a central venous catheter will be inserted as well.~     Sampling in the patient groups shall be performed as follows:~        -  pre- and postoperative evaluation of standard laboratory parameters in all patients~        -  evaluation of standard laboratory parameters and arterial Astrup test during and after~          surgery in group 1, if the blood loss volume reaches 1,5 ml/kg/minute during 20 minutes~        -  in case of elective surgery: thromboelastometry and arterial Astrup test during and~          after surgery in group 2 if the blood loss volume reaches 1,5 ml/kg/minute during 20~          minutes~        -  in case of acute surgery: thromboelastometry and arterial Astrup test before, during and~          after surgery in group 2~        -  in case of positive anamnesis, preoperative platelet aggregation test in both groups~          Besides the above samplings, routine lab tests (blood gas, blood count, sodium (Na),~          potassium (K), parameters of renal and liver function, clotting and inflammation, lactic~          acid, blood sugar) will be performed every day as usual during intensive therapy.~   "
10695|NCT03426826|"~     The purpose of this study is to find out if transplant of fecal matter (stool), also known as~     fecal microbiota transplantation (FMT), from a healthy person into the intestines of children~     and young adults with Autism Spectrum Disorder (ASD).~      For this study children between the ages of 5-17years will be recruited over 2 years.~     Children will be recruited who receive an ASD diagnosis using the gold-standard Autism~     Diagnosis Observation Schedule -2 (ADOS-2) using module 1, 2 or 3 (none, limited or no~     moderate expressive language). Children diagnosed with these modules of the ADOS-2 may be at~     greater risk for GI disorders and rigid-compulsive behaviors. Additional assessment of~     rigid-compulsive behaviors and social communication will be done using the Repetitive~     Behavioral Scales-Revised (RBS-R) and Social Responsiveness Scale-2 (SRS-2), respectively.~     KBIT (the Kaufman Brief Intelligence Test) is used at baseline to obtain patient IQ. Total~     evaluation time is approximately 90 minutes. Following baseline symptom evaluation, a medical~     exam will be performed to determine whether each child is expressing specific GI symptoms. In~     addition, parents will fill out the Questionnaire for Pediatric Gastrointestinal Symptoms-~     Rome III (QPGS-III). Once an ASD diagnosis is confirmed, FMT treatment will be initiated,~     which typically occurs within 4-6 weeks of the initial diagnosis. Half 50% of the children~     (n=5) will receive the equivalent of 50 g of stools from a healthy donor into the jejunum~     through upper endoscopy and the other 50% off children (n=5) will receive Saline solution as~     Placebo control through upper endoscopy.~      Subjects will have a total of 5 visits within 24 weeks including phone call follow up on Day~     7 after FMT.~   "
10696|NCT03426813|"~     Pneumonia is a common health problem.This thesis may clarify whether early mobilization~     influence the time these patients are hospitalized, whether they are rehospitalized and~     whether it is possible to reduce the mortality rate.~   "
10697|NCT03426800|"~     Acupuncture as a treatment for headache in children~   "
10698|NCT03426787|"~     The overall purpose of this study is to develop and test a web-based decision aid (DA) to~     support patients with Hepatitis C and Chronic Kidney Disease during decisions about whether,~     when, and how to treat each illness. Patients will have the opportunity to learn about their~     hepatitis C and kidney disease, initiate thought about what matters most to them and choose a~     treatment plan for their liver and kidney disease that works best for them. Investigators~     will evaluate the tool's efficacy, usability, and the likelihood of using it in clinical~     practice. There are three (3) primary aims of this project: (1) to develop the DA; (2) to~     pilot-test the DA to determine efficacy, usability and likelihood of using it in routine~     practice; (3) to explore stakeholders feedback on the usefulness of the DA and likelihood of~     implementing the tool.~   "
10699|NCT03426774|"~     Movement is important for overall health. Lack of movement has been shown to be associated~     with numerous diseases. This study will assess the validity and usefulness of two innovative~     low risk, non-invasive wellness devices, the Gentle Jogger® and the Gentle Jumper that~     passively simulate the physical activities of jogging and jumping, respectively. The study~     will evaluate whether or not each of the devices in different body postures (seated, lying~     down, slight recumbent and slight head down) produces changes in blood pressure, and indices~     of dilatation of blood vessels, in a younger (25-59yr) and older (> 60 yrs.) subject~     population. Volunteers will be paid for their participation in the study.~   "
10700|NCT03426761|"~     Because of its prolonged terminal half-life, dalbavancin is an extremely attractive option in~     treating Gram-positive infections caused by S. aureus including MRSA, and streptococcal~     species. Systemic bacterial infections due to Staphylococci such as osteomyelitis and septic~     arthritis, are conditions which require prolonged IV therapy, typically for at least 3-6~     weeks, though sometimes more. Due to dalbavancin's prolonged terminal half-life, it may offer~     the opportunity to substantially reduce costs and morbidity in native joint and prosthetic~     joint infections with one infusion every fourteen days until completion of therapy.~   "
10701|NCT03426748|"~     H17-02904 is a randomized comparison of low dose rate vs. high dose rate prostate~     brachytherapy for favorable and intermediate risk prostate cancer suitable for brachytherapy~     as monotherapy. This is a continuation with expanded accrual of the randomized Pilot study~     H15-02103~   "
10702|NCT03426735|"~     The purpose of this study is to determine the best intervention after the extravasation of~     the iodinated contrast medium out of a vessel into the surrounding tissues.~   "
10703|NCT03426722|"~     we aim to evaluate the efficacy of L-carnitine for the treatment of muscle cramps after~     imatinib in patients with GIST and apply in the future.~   "
10704|NCT03426709|"~     The aim of this study is to assess the efficacy in Primary Care (PC) of a low intensity~     psychological intervention applied using Information and communication technologies (ICTs)~     for the treatment of multimorbidity in PC (depression and diabetes/low back pain) by a~     randomized controlled trial (RCT). A protocol will be design that combines face to face~     intervention with a supporting online program that will be tried in a RCT conducted in 3~     different regions (Andalucía, Aragón, y Baleares). Our main hypothesis is that improved usual~     care combined with psychological therapy applied by ICTs, will be more efficacious to improve~     the symptomatology of multimorbidity, compared to a group with only improved treatment as~     usual six months after the end of treatment.~   "
10706|NCT03426683|"~     There are many limitations in the current treatments of Inflammatory Bowel Diseases(IBD)~     which includes Ulcerative Colitis（UC) and Crohn's Disease(CD). Some patients have no or~     little reaction to the traditional drugs. Now the investigators realized that the intestinal~     microbiota is closely associated with the development of Inflammatory Bowel Diseases. In~     recent years, a retrospective study showed that the overall efficiency of intestinal~     microbiota transplantation for IBD was 79%, the overall remission rate was 43%, which opened~     a new chapter in the treatment of IBD. So the standardized intestinal microbiota~     transplantation is considered to be simple but effective emerging therapies for the treatment~     of IBD. In this project the investigators intend to carry out a single-center, randomized,~     single-blind clinical intervention study. The investigators plan to recruit patients with IBD~     in China. The patients will be randomly divided into two groups, one group will be given~     treatment of standardized intestinal microbiota transplantation, the other will be simply~     treated with traditional drugs, followed up for at least 1 year. The investigators aim to~     determine the efficiency, durability and safety of Intestinal Microbiota Transplantation for~     IBD treatment, and further to explore which major bacteria may effect in this project.~   "
10707|NCT03426670|"~     Transgender, male, and female sex workers are 49, 21 and 14 times as likely to be~     HIV-infected as other adults in the general population. In Uganda, sex workers have high HIV~     seroprevalence (35-37%) and account for 10% of new HIV infections. Two robust,~     evidence-based, self-controlled HIV prevention tools are available -- HIV self-testing~     (HIVST) and antiretroviral pre-exposure prophylaxis (PrEP) -- but these are not currently~     well utilized among sex workers. HIVST and PrEP are complementary tools that could be~     combined to build self-efficacy and empowerment, increase PrEP adherence and reduce sexual~     risk behaviors. However, research is needed to show how combination HIVST and PrEP may have a~     synergistic impact on uptake and use of each prevention intervention. The investigators will~     conduct a randomized trial among sex workers initiating PrEP in Uganda to test if HIV~     self-testing increases PrEP adherence among HIV-uninfected sex workers (Aim 1), changes~     sexual risk behavior in sex workers taking PrEP (Aim 2), and influences prevention choices~     among sex workers and their partners (Aim 3). The investigators will use novel technologies~     (real-time electronic monitoring with Wise pill technology and mobile phone surveys) to~     characterize patterns of PrEP adherence, and assess how use of HIVST and PrEP aligns with~     sexual risk behaviors. Additionally, the investigators will conduct in-depth qualitative~     interviews to explore the mechanisms through which combined HIVST and PrEP delivery may be~     synergistic and empowering. This study will be the first to jointly evaluate HIVST and PrEP~     in sex workers.~   "
10708|NCT03426657|"~     First-line treatment of locally advanced HNSCC with double checkpoint blockade and~     radiotherapy dependent on intratumoral CD8+ T cell Infiltration.~   "
10709|NCT03426644|"~     Investigators seek to determine if an online behavioral economic based intervention can be~     developed to target increases in childhood time in bed (TIB).~   "
10710|NCT03426631|"~     Obstructive sleep apnea (OSA) is common and has major health implications but treatment~     options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle~     activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared~     to normal subjects. In this protocol the investigators will test the effect of DAW1033B2~     administered before sleep on OSA phenotype traits and OSA severity during sleep.~   "
10711|NCT03426618|"~     This is a local, prospective observational study (regulatory post marketing surveillance) to~     access the safety and effectiveness of Baraclude in Korean pediatric patients with chronic~     HBV infection who are between the ages of 2 and less than 16 years.~   "
10712|NCT03426605|"~     A Phase 1 Dose-Escalation Study of LAM-003 in Patients with Acute Myeloid Leukemia~   "
10713|NCT03426592|"~     HIV persists despite antiretroviral therapy (ART) and is associated with chronic~     inflammation. This inflammation is thought to prevent an effective immune response against~     the virus and is mediated at least in part by gut epithelial permeability and microbial~     translocation. HIV accumulates preferentially within Th17 cells with time on ART; these~     memory CD4+ T cells are highly susceptible to HIV infection and are concentrated within the~     gut. Vitamin D promotes gut epithelial integrity in animal models and exerts~     anti-inflammatory effects on the human immune system including down-modulation of Th17 cell~     frequency. This study will evaluate whether high dose vitamin D is able to reduce immune~     activation and Th17 cell frequency, to improve gut barrier integrity and the gut microbiome~     and reduce HIV persistence in participants on long-term suppressive ART.~   "
10714|NCT03426579|"~     This study evaluates the correlation between sedation depth monitoring obtained by NeuroSENSE~     ® NS 701 Monitor and reflexes during intravenous anesthesia in children undergoing direct~     laryngoscopy for surgical procedures.~   "
10715|NCT03426566|"~     The prevalence of abnormal plantar pressure distribution (APD) and its connection with~     various factors among patients with diabetes is not known. The purpose of this study was to~     evaluate the prevalence of the APD and its connection with selected factors among patients~     with diabetes.~   "
10716|NCT03426553|"~     The aim of the study is to evaluate the effectiveness and safety of the application of~     pathogen inactivated RBC suspension in children with oncological and hematological diseases.~   "
10717|NCT03426540|"~     To evaluate the safety and efficacy of intravitreal conbercept after vitrectomy for the~     management of early-stage proliferative diabetic retinopathy (PDR).~      Hypothesis: intravitreal conbercept therapy may promote functional and anatomic recovery from~     PDR. intravitreal conbercept therapy may be a useful and safe method for improving visual~     outcomes of surgery for early-stage PDR.~   "
10731|NCT03426358|"~     ELASTOVOD is a prospective multicenter study, involving several centers of Onco-haematology~     in Italy. Investigators perform hepatic elastographic measurements (with Transient~     Elastography, ARFI or 2D-SWE) on patients undergoing HSCT, at baseline before transplantation~     (T0) and at T1/T2/T3 after HSCT (+9/10, +15/17, +22/24).~      SOS/VOD diagnosis was performed according to clinical criteria.~   "
10732|NCT03426345|"~     This study will evaluate the safety and efficacy of Relamorelin compared to placebo in~     patients with diabetic gastroparesis. Patients will report daily severity scores of their~     diabetic gastroparesis symptoms.~   "
13330|NCT03392376|"~     Delirium is a frequent condition in the Intensive Care Unit (ICU) with no existing~     evidence-based treatment. The aim of the AID-ICU study is to assess the benefits and harms of~     haloperidol treatment for the management of ICU acquired delirium.~   "
10718|NCT03426527|"~     Tracheal resection and reconstruction (TRR) is the treatment of choice for most patients with~     tracheal stenosis or tracheal tumors .The post intubation tracheal stenosis is the common~     indication for (TRR).The immediate postoperative period can be anxiety provoking for some~     reasons such as requirement to maintain a flexed neck, oxygen mask, and surgical pain which~     inadequately treated.~      Bilateral superficial cervical plexus block (BSCPB) is a popular regional anesthesia~     technique for its feasibility and efficacy. The use of regional anesthesia in combination~     with general anesthesia may lighten the level of general anesthesia required , provide~     prolonged postoperative analgesia and reduce the requirements for opioid analgesics~      Dexmedetomidine is a highly selective α2 agonist with high affinity for α2 adrenergic~     receptors and less α1 effects, which is responsible for the hypnotic and analgesic effects.~     Previous trials demonstrated that perineural dexmedetomidine in combination with bupivacaine~     enhanced sensory and motor block ,without neurotoxicity ,in both experimental and clinical~     studies.~      Levobupivacaine, is S-enantiomer of bupivacaine, has strongly emerged as a safer~     alternative for regional anesthesia than bupivacaine . Levobupivacaine has been found to be~     equally efficacious as bupivacaine, but with a superior pharmacokinetic profile.~      Clinically, levobupivacaine has been observed to be well tolerated in regional anesthesia~     techniques both after bolus administration and continuous post-operative infusion.~   "
10719|NCT03426514|"~     This study is designed to evaluate the short-term and long-term results after three-port~     laparoscopic surgery for colorectal cancer（TLSC） compared with conventional laparoscopic~     surgery for colorectal cancer（CLSC）.~   "
10720|NCT03426501|"~     165 patients admitted to two hospitals were included and short-time HRV measurements were~     obtained. Mortality data were gathered from the Norwegian central address register. Patients,~     close relatives of patients and in some cases their general physicians or nursery home~     physicians were interviewed six months postoperatively regarding the incidence of pneumonia,~     cardiac events or stroke.~   "
10721|NCT03426488|"~     NSHDS (Northern Sweden Health and Disease Study) is an umbrella term for a prospective~     biobank with related survey data. The sample collection consists of three subcohorts,~     Västerbotten Intervention Programme (VIP), Mammography Screening Project (MA) and MONICA~     (MONItoring of Trends and Determinants in CArdiovascular Disease). The blood samples are~     stored at the Northern Sweden Biobank.~   "
10722|NCT03426475|"~     Previously,six measures were developed for a better collaboration of general practitioners~     and nurses in nursing homes in a qualitative multistep bottom-up process. These measures,~     summarised as the interprof ACT intervention, shall improve the flow of information and the~     communication between the involved parties and lead to more transparency and effectiveness~     regarding treatment decisions of nursing home residents.The major aim of this trial is to~     examine the clinical effectiveness of interprof ACT. The main hypothesis is that~     implementation of interprof ACT reduces the cumulative incidence of hospitalisations of~     nursing home residents within 12 months from 50% to 35% (15% absolute reduction).~   "
10723|NCT03426462|"~     In order to determine the speed of onset of the anaesthetic propofol in children,~     investigators will compare the two age groups 1-6 years vs 8-13 years. The primary outcome~     measure is the time to peak effect of a bolus of proposal, which is measured by analysing the~     electroencephalogram by using the permutation entropy. Further pharmacodynamic modelling will~     enable investigators to quantify the difference with age in the hypnotic effect of propofol.~   "
10724|NCT03426449|"~     The present study aimed to compare the standard lateral internal sphincterotomy at 3 o'clock~     with posterolateral internal sphincterotomy at 5 o'clock in regards healing time,~     postoperative recurrence and complications, particularly fecal incontinence.~   "
10725|NCT03426436|"~     This study, sponsored by Nihon Kohden, aims to determine the sensitivity and specificity of~     synthesized 18-lead electrocardiogram (ECG) in the diagnosis of posterior-lateral and/or~     right-ventricular ischemia, using actual 18-lead ECG as the gold standard. The synthesized~     18-lead ECG calculates six extra leads of information from the standard 12-lead ECG done in~     the Emergency Department (ED). Nihon Kohden has created synECi18 Technology, which can~     mathematically synthesize and display the extra leads.~      The patient population (n=300) will consist of patients who present to the North Shore~     University Hospital or Long Island Jewish Medical Center ED with a chief complaint of chest~     pain, chest pressure, or chest discomfort. These patients will be receiving a standard~     12-lead ECG as part of their routine clinical care. Patients with ST-Elevation Myocardial~     Infarction (STEMI) and a known positive troponin value will be excluded from the study.~      Trained ED study technicians will use ECG machines provided by Nihon Kohden to obtain two~     consecutive 15-lead ECGs. The two 15-lead ECGs are then saved onto the ECG machine.The saved~     information will later be input into an algorithm to calculate the synthesized 18-leads. The~     actual 18-leads (composed of the two 15-leads conducted in the ED) will be compared with the~     synthesized 18-leads produced by the synECi18 technology. A study cardiologists will evaluate~     the actual 18-lead ECGs and synthesized 18-lead ECGs and determine whether there is~     posterior-lateral and/or right-sided ventricular ischemia. The cardiologists will be blinded~     to the type of waveform they are analyzing (synthesized versus actual).~      The study will not interfere with patient care or treatment, however, the two 15-lead ECGs~     done in the ED will be shown to the physician who can determine whether or not to order an~     official 18-lead ECG in the hospital's electronic medical record system.~      It is hypothesized that the synECi18 synthesized 18-lead ECGs will provide high sensitivity~     and specificity for diagnosing posterior-lateral and/or right-ventricular ischemia, with the~     actual 18-lead ECGs being used as the reference for comparison.~   "
10726|NCT03426423|"~     People with diabetes still smoke at equivalent rates as non-diabetics. There is lack of~     evidence regarding interventions for smoking cessation among individuals with diabetes. The~     aim of this project is to assess the 12 months efficacy of a smoking cessation intervention~     tailored to diabetes and gender specificities, in a population of 500 smokers with type 2~     diabetes. The secondary objectives are to assess the impact of smoking cessation on~     anthropometric outcomes, diabetes control and renal function and fecal microbiota.~   "
10727|NCT03426410|"~     Purpose and background:~      The purpose of the study is to investigate physiotherapeutic courses of rehabilitation in the~     primary sector for low back pain patients. This is done by identifying both how~     physiotherapeutic rehabilitation is organized in the primary sector and further what~     different types of physiotherapeutic interventions are offered for this patient group.~     Furthermore the study aims to evaluate to what extent existing physiotherapeutic~     rehabilitation practice adheres with the national and international guidelines and~     recommendations for low back pain rehabilitation.~      Methods:~      A quantitative survey is carried out, which includes development and validation of a~     questionnaire for the purpose, and this is subsequently distributed electronically to private~     and public providers of physiotherapy rehabilitation in all 19 municipalities in Central~     Denmark Region. Approximately 500 physiotherapists will be asked to participate in the survey~     in the period February to March 2018.~   "
10728|NCT03426397|"~     The aim of this prospective observational cohort study is to provide short and long term~     oncological and functional outcome data on organ preserving treatment in good responders~     after a standard indication for neoadjuvant (chemo)radiation for rectal cancer.~   "
10736|NCT03426293|"~     Aim of the MANCO study is to establish for once and for all that monitoring the effect of~     heparin during NCVI (Non-Cardiac Vascular Interventions) is essential to ensure the~     individual patient of safe and tailor-made anticoagulation. Not measuring the effect of the~     administered heparin exposes the patient to unnecessary risks of thrombo-embolic and bleeding~     complications. First aim of the MANCO study is to prove that the standardized bolus of 5000~     IU of heparin, used by 90% of vascular specialists in Europe, results in inadequate~     anticoagulation in more than 80% of patients. These measurements will be performed using the~     Hemostasis Management System by Medtronic.~   "
10737|NCT03426280|"~     To combat post-transplant weight gain, we seek to expand Stanford Kidney Transplant's~     multidisciplinary platform to include physical activity monitoring and coaching using the~     Apple Watch.~   "
10738|NCT03426267|"~     The efficacy and safety of SDN-037 twice daily will be evaluated and compared with vehicle~     for the treatment of inflammation and pain associated with ocular surgery.~   "
10739|NCT03426254|"~     To assess the safety and efficacy of two forms of Talazoparib therapy (injections~     subcutaneously Talazoparib and oral form for the treatment in the equivalent therapeutics~     dose~   "
10740|NCT03426241|"~     This study comparatively evaluate the expressions of MMP-2 and MMP-9 in smoker vs non-smoker~     chronic periodontitis patients as well as periodontally healthy subjects. the hypothesis of~     this study was that smoking may interfere with periodontal disease by effecting MMP-2 and~     MMP-9 expressions.~   "
10741|NCT03426228|"~     A quantitative prospective cohort study will be conducted, where blood samples will be~     collected at different timings during the IVF protocol, to assess the impact of fertility~     medications on metabolic parameters of patients undergoing IVF treatment.~   "
10742|NCT03426215|"~     This observational study will assess the long-term course and effect of Korean medicine~     treatment in lumbar intervertebral disc herniation patients who received integrative Korean~     medicine treatment for 24 weeks as part of a previous clinical study.~   "
10743|NCT03426202|"~     The study aims to examine whether a single dose of modafinil (200mg, p.o.) can affect~     feedback-based learning and interference processing in healthy male subjects.~   "
10744|NCT03426189|"~     The aim of this project is to determine whether latent HIV is enriched in cells expressing~     certain proteins (receptors) on their surface and whether it is possible to eliminate these~     cells through the use of drugs that specifically target these proteins. Lymph nodes are known~     to contain very high numbers of HIV infected cells.~   "
10745|NCT03426176|"~     the study aims to explore whether there is an interaction between oxytocin and serotonin in~     the regulation of emotion-based behavior by using a between-subject randomized double blind~     pharmacological fMRI design during which 4 groups of healthy male subjects will receive~     combinations of oxytocin nasal-spray (versus placebo) and acute tryptophan depletion (ATD,~     versus placebo)~   "
10746|NCT03426163|"~     Knee MRI is difficult for patients to understand as the image offers a single plane image.~     Accordingly,investigators sought to transfer the MRI image to 3-dimensional virtual reality~     system by Mesh rendering technique.~   "
10747|NCT03426150|"~     40 specimens were prepared from fresh-extracted human molars and further embedded using the~     acrylic resin. Specimens were randomly divided into 2 groups according to the treatment~     before in vivo erosion (n=20): CPP-ACP for 3 min (CPP-ACP group) and deionized water for 3~     min (control group). 10 healthy volunteers were recruited and customized maxillary appliance~     containing 4 specimens (2 from CPP-ACP group and 2 from control group) was fabricated for~     each volunteer. Participants were instructed to drink 150 ml cola in 5 min using the gargling~     method after placing appliances intraorally for 2 h. The in vivo attacks were performed 4 X 5~     min with 1-h interval daily over 7 d. The surface microhardness and surface microstructure of~     the specimens were evaluated at the baseline and after the treatment. The data were~     statistically analyzed using three-way ANOVA and post hoc tests. Data were considered~     statistically significant at a level of P <0.05.~   "
10748|NCT03426137|"~     The United States (US) faces a crisis of pain management. According to the 2012 National~     Health Interview Survey, almost 50 million adults in the US reported having significant~     chronic or severe pain (Nahin 2015). Doctors in the US still prescribe opioids across the~     board for pain despite a growing recognition of an epidemic of opioid overdose and use~     disorder. Few solutions have been successfully proposed and implemented. Placebos represent a~     novel and potentially fruitful means of addressing this issue. However, clinicians often use~     placebos deceptively and with little rationale or evidence of benefit, making their use~     ethically problematic. In contrast with their typical current use, a provocative line of~     research suggests that placebos can be intentionally exploited to extend analgesic~     therapeutic effects. Recently, we reviewed a database of placebo studies including 22 studies~     in both animals and humans hinting of evidence that placebos may work as a dose extender of~     active painkillers. Placebos given after repeated administration of active treatments can~     acquire medication-like effects based on learning mechanisms.~      Here, we will test if dose-extending placebos are effective in relieving clinical acute pain~     in opioid patients with rib fractures. Patients will be randomized to three arms. Arm 1 will~     be a Full Dose (FD) group, which will receive all NSAIDs as described in the Guidelines for~     NSAID use in Orthopedic Patients and Oxycodone (10mg). Arm 2 will be a Partial Reinforcement~     (PR) group, which will receive NSAIDs, Oxycodone (10mg), and placebos to reach a 50%~     reduction of the total intake of opioids. Finally, Arm 3 will be a Control (C) group~     receiving NSAIDs and placebos. Patients will be assigned to one of three arms according to a~     1:1:1 schedule of randomization. Study IDs will be generated by the pharmacy and blinding~     will occur by ensuring that oxycodone and placebos look, smell, and taste identical. Rescue~     therapy will be provided as needed. This novel prospect of placebo use has the potential to~     change our general thinking about painkiller treatments, the typical regimens of painkiller~     applications, and the ways in which treatments are evaluated.~   "
10749|NCT03426124|"~     This registry is designed to understand acoustic pulse thrombolysis (APT) treatment regimens~     used as standard of care globally for pulmonary embolism. The registry will include~     individuals who have already received the APT treatment and those that will undergo APT~     treatment.~   "
10786|NCT03425643|"~     This trial will evaluate the safety and efficacy of pembrolizumab (MK-3475) in combination~     with platinum doublet neoadjuvant chemotherapy (NAC) before surgery [neoadjuvant phase],~     followed by pembrolizumab alone after surgery [adjuvant phase] in participants with~     resectable stage IIB or IIIA non-small cell lung cancer (NSCLC). The primary hypotheses of~     this study are that neoadjuvant pembrolizumab (vs. placebo) in combination with NAC, followed~     by surgery and adjuvant pembrolizumab (vs. placebo) will improve: 1) event free survival~     (EFS) by biopsy assessed by blinded central pathologist or by imaging using Response~     Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) assessed by blinded independent~     central review (BICR); and 2) overall survival (OS).~   "
10750|NCT03426111|"~     Nonalcoholic steatohepatitis is a growing public health problem affecting over 5% of the~     population. These patients are at increased risk of cardiovascular and liver-related death~     and have higher rates of malignancy.~      The currently standard of care is weight loss and physical exercise, with histological and~     analytical improvement in patients achieving a 5-10% reduction in body weight. However, less~     than 25% of the subjects achieve this goal. In obese patients , restrictive surgical~     treatments and gastric bypass have been successful in improving the metabolic syndrome,~     insulin resistance and liver histology.~      Currently, less invasive and less costly endoscopic techniques are being developed. These~     techniques also achieve a gastric restriction with similar results than bariatric surgery.~     One of these is the OverStitch® system (Apollo Endosurgery, Austin, TX, USA). Our aim is to~     evaluate the efficacy and safety of this method in the improvement of liver histology in~     obese patients with nonalcoholic steatohepatitis.~   "
10751|NCT03426098|"~     To assess the safety, efficacy and patient satisfaction associated with the treatment of~     facial wrinkles using the Secret Micro-Needle Fractional RF System® (Ilooda Co., Ltd., Suwon,~     South Korea).~   "
10752|NCT03426085|"~     The purpose of this study is to conduct an interventional, one year, randomized, double~     blind, placebo-controlled trial with Liraglutide in patients with type 2 diabetes (diabetes~     duration of >6 months and <10 years, HbA1c <10%) to evaluate its effects on the peripheral~     autonomic nervous system, as well as inflammatory markers, and measures of oxidative and~     nitrosative stress.~   "
10753|NCT03426072|"~     The overall aim of the program is to advance knowledge translation science in order to~     improve clinical and staff related outcomes in long term care facilities (nursing homes) in~     western Canada. SCOPE will assess the effect of Care Aide led Quality Improvement efforts on~     staff quality of work life as well as resident quality of care. A key element of SCOPE is a~     leadership development stream which introduces complexity science and education on quality~     improvement which aims to support front line teams with their improvement initiative~   "
10754|NCT03426059|"~     The protocol aims to comprehensively define the phenotype of Phelan-McDermid Syndrome and to~     identify potential genetic factors, which may play a role in the variability of the disease's~     outcomes. The first aim involves a physical exam, a neurological exam, collection of medical~     history information, a clinical genetic evaluation, blood work and neuropsychological~     assessments. If clinically indicated, the protocol collects information from medical tests.~     These medical tests may include electrocardiography, echocardiography, renal ultrasonography,~     and renal ultrasound.~   "
10755|NCT03426046|"~     The aim of this randomized controlled trial is to compare partial pulpotomy treatments with~     Biodentine®, calcium hydroxide (CH) and Mineral Trioxide Aggregate (MTA) in cariously exposed~     asymptomatic young permanent teeth clinically and radiographically for 1 year and evaluate~     root developments with Image J Software Program. The null hypothesis of this study is~     Biodentine® will promote healing with high success rates and induce root development more~     than CH and MTA.~   "
10756|NCT03426033|"~     This is a single center, open label, single sequence, two-treatment, two-period drug-drug~     interaction study to evaluate the effect of multiple doses of ISIS 681257 on the~     pharmacokinetics of a single dose of warfarin.~   "
10757|NCT03426020|"~     Compare the effects of pharmacologic and nonpharmacologic premedications on postoperative~     emergence delirium and preoperative anxiety, vital parameters, blood pressure, heart rate,~     SpO2, and pain at PACU 15 minutes after adenotonsillectomy .~   "
10758|NCT03426007|"~     This is a feasibility study intended to demonstrate the Previvo Uterine Lavage System's~     ability to recover embryos from the uterus following either natural cycle (NC)/intrauterine~     insemination (IUI), or controlled ovarian hyperstimulation (COH)/intrauterine insemination~     (IUI).~   "
10759|NCT03425994|"~     Tenofovir alafenamide (TAF), active against both HIV and HBV, demonstrates similar antiviral~     efficacy but improved renal and bone safety compared to tenofovir disoproxil fumarate (TDF)~     in HIV-1-infected patients. HIV-1-infected patients whose estimated glomerular filtration~     rate (eGFR) between 30-69 mL/min were shown to have minimal change in eGFR and improved~     proteinuria, albuminuria, and bone mineral density after switching to a single-tablet regimen~     containing Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (EVG/cob/FTC/TAF). For~     treatment of chronic HBV infection, a similar proportion of HBV-monoinfected patients who~     received TAF and those who received TDF achieved undetectable HBV DNA at 48 weeks of therapy.~     Although TAF is effective for HIV and HBV suppression, data on efficacy of TAF are limited~     among patients co-infected with both viruses. Currently, only one open-label, single-arm~     study had investigated the efﬁcacy and safety of TAF in HIV/HBV-coinfected patients. In this~     study, 72 HIV/HBV-coinfected patients switching to EVG/cob/FTC/TAF were enrolled, and 91.7%~     of them maintained or achieved virologic suppression for both HIV and HBV at 48 weeks of~     therapy. Seroconversion occurred in 2.9% of HBsAg-positive participants and in 3.3% of~     HBeAg-positive participants. Improvements in eGFR and declines in markers of bone turnover of~     the participants were observed. The limitations of the above study are the small sample size.~     Taiwan is a country hyperendemic for HBV infection, with 19.8% of HIV-positive patients who~     were born before the implementation of nationwide neonatal vaccination in 1986 had concurrent~     chronic HBV infection. To further the understanding of the difference between TAF- and~     TDF-containing combination antiretroviral therapy among HIV/HBV-coinfected patients, the~     investigators plan to conduct an observational study to evaluate the efficacy and safety of~     EVG/cob/FTC/TAF as maintenance treatment of HIV/HBV-coinfected patients.~   "
10760|NCT03425981|"~     The subjects will be randomly distributed into 3 experimental groups: training with basic~     global electrostimulation (WB-EMS-SRT), training with specific global electrostimulation for~     runners (WB-EMS-WT) and control group (CG).~      Initially and at the end of the intervention period, which will consist of six weeks, the~     subjects will undergo a series of tests: (1) Maximum incremental effort test in tapestry to~     exhaustion to determine cardiorespiratory capacity (VO2max) and thresholds (aerobic and~     anaerobic). (2) Submaximal carpet test at constant speed to determine race economy (EC). (3)~     Lower train power test (CMJ and Abalakov). (4) Weight, size and waist circumference. The~     aforementioned tests will be carried out on different days to avoid the effect of fatigue on~     performance with a break of more than 48 hours between tests.~      The participants in the control group will maintain the volume and intensity of the training~     prior to the intervention study and the subjects of the WB-EMS and WB-EMS-AC groups will~     substitute one conventional training day for one with global electrostimulation for six~     weeks; the training of the first group will be non-specific and that of the second specific~     for runners and the duration of both will be 20 minutes.~   "
10797|NCT03425500|"~     To compare bridging reconstruction to superior capsular reconstruction using human dermal~     allograft augmentation for repair of massive rotator cuff tears.~   "
14510|NCT03376997|"~     This study will be conducted to evaluate the bioavailability of a single 12 milligram (mg)~     dose of perampanel intravenous infusions of different durations relative to a single 12 mg~     dose of perampanel oral tablet in healthy participants.~   "
10761|NCT03425968|"~     Knee hyperextension, also called genu recurvatum or back knee, is commonly seen in women,~     people with ligamentous laxity, stroke and cerebral palsy patients. This faulty posture would~     result in excessive tension of the passive tissues such as anterior cruciate ligament (ACL)~     and posterior capsule of the knee. Subjects may also develop compensations at hip and ankle~     joint, as well as lower extremity malalignment. Muscles surrounding the knee could also~     become dysfunctional when performing functional tasks requiring stability during terminal~     knee extension, during which uncontrolled knee hyperextension could easily be utilized to~     lock the joint for stability in gait and stair climbing. In athletes, landing from a jump on~     an extended knee is one of the common reasons resulting in ACL injury. Little is known about~     the injury rate of athletes with knee hyperextension who participate in sports involving~     jump-landing activities.~      The aim of the study is to explore if knee hyperextension is associated with poor lower~     extremity alignment and dynamic control and injury rate in athletes requiring jump-landing~     activities.~      One of the study hypothesis is that athlete with knee hyperextension can find more~     compensatory lower extremity alignments and poor control in dynamic movement than control~     group.~      The other hypothesis is with or without knee hyperextension, the parameter of lower extremity~     alignment and dynamic control can predict injury rate in jump landing athlete.~   "
10762|NCT03425955|"~     Aesthetic performance of SUNEKOS® 200 injectable treatment on main sign of face skin aging~     in normotypic or overweight subjects with rounded, oval or squared face and in thin subjects~     with oval or triangular face and sagging skin.Interstitial or cushion technique in~     comparison to bolus technique at five points (half - face method within subjects).~   "
10763|NCT03425942|"~     Cognitive behavioural therapy (CBT), that is designed to be short, concise and user friendly~     is compared to applied relaxation techniques as treatment for insomnia comorbid with chronic~     pain. Both treatments are administered via internet and participants are randomized to ether~     treatment arm.~   "
10764|NCT03425929|"~     Severe traumatic experiences such as falling victim to assault, torture, or rape have~     deleterious effects. Clinical manifestations include intrusions, avoidance behavior, and~     hyperarousal, which are associated, at a circuit level, with hyperfunction of the amygdala~     and hypofunction of prefrontal cortex (PFC) subregions. In up to 50 % of the cases,~     resilience is not sufficient and trauma-exposed individuals develop posttraumatic stress~     disorder (PTSD). Oxytocin (OXT) is a hypothalamic peptide hormone that exerts anxiolytic~     effects. Recent clinical trials provide preliminary evidence that post-trauma administration~     of OXT could be effective as a preventive intervention for PTSD in a subsample of individuals~     exhibiting early PTSD symptoms prior to the onset of the disorder. However, the underlying~     neurobiological mechanisms are unclear. Therefore, the rationale of the present project is to~     expose a sample of healthy participants to experimental trauma in order to explore the~     circuit mechanisms by which OXT influences, and interferes with, traumatic experience.~     Functional magnetic resonance imaging (fMRI) will be employed in order to elucidate the~     long-term effects of intranasal OXT on trauma-induced intrusions, amygdala and PFC responses~     during an emotional face matching task and resting state functional connectivity.~   "
10765|NCT03425916|"~     To describe and compare abdominal muscles and inter-rectus distance conditions in postpartum~     period in comparison with nulliparous women. Also to describe the activation changes during~     different abdominal exercises.~   "
10766|NCT03425903|"~     The aim of this study is to evaluate the effectiveness of an intervention with sessions of 3~     minutes of whole body cryotherapy (WBC) in the Cryosense cabin. Measurement period time: 8~     weeks.~   "
10767|NCT03425890|"~     The aim of this study is to investigate the effect of SURE program on UL recovery during~     first few weeks post-stroke. A randomised blinded controlled pilot trial will be conducted.~     Twenty people with stroke will be randomly allocated to 4-weeks of SURE program or education~     program. This is to perform on top of their usual care. To determine the clinical benefit,~     all participants will be assessed pre-, 2 weeks during the training, post-training, 1-month~     and 3-month follow-up using a range of impairment and activity measures. To determine the~     cortical activation (fMRI), structural (FLAIR and DTI) and functional (resting state fcMRI)~     connectivity of cortical motor regions, all participants will undergo a 3T MRI pre-, post-~     and post-3 months after training.~   "
10768|NCT03425877|"~     The present study therefore aims at studying and evaluating the state of activation by~     psycho-physiological, behavioral, and subjective responses of individuals with Stroke and~     Parkinson's disease in contexts from the gradual increase in cognitive and stress loads, in~     order to provide information on the possibility Use of biofeedback devices in rehabilitation~     contexts.Objectives: assess the psychophysical response; to describe the configuration of~     physiological activation patterns; to determine the interaction effect between task type and~     pathology; to assess behavioral response;to describe the performance; to determine the~     interaction effect between task type and pathology; to evaluate the subjective response; to~     measure the degree of awareness of your state and your performance.~   "
10769|NCT03425864|"~     The goal of the present study is to compare the esthetic result and stability of gingival~     tissue over the immediate implant only and immediate implant with connective tissue in~     patients with single or multiple non-restorable tooth or teeth in the esthetic zone. The main~     null hypothesis to be tested is that the addition of SCTG to immediately placed implants will~     not significantly differ from immediately placed implant alone as regard gingival tissue~     stability.~   "
10785|NCT03425656|"~     This is A Phase III, randomized, two-armed, patient-outcome assessor-data analyzer blinded,~     parallel active controlled non-Inferiority clinical trial study to evaluate efficacy and~     safety of AryoTrust™ (Aryogen Trastuzumab in comparison to Herceptin® (Genentech/Roche) in~     patients with Human Epidermal Growth Factor Receptor 2-Positive breast cancer. The main~     objective is to verify the non-inferiority of AryoTrust™ (Aryogen trastuzumab) vs. Herceptin®~     (Genentech/Roche trastuzumab), both given concomitantly with docetaxel after doxorubicin plus~     cyclophosphamide in the neoadjuvant setting according to pathological complete response (pCR)~     as primary objective and objective response (cOR), clinical complete response (cCR), clinical~     partial response (cPR), clinically no change (cNC), clinical progressive disease (cPD),~     breast conservation rate as Secondary objectives of this study. Evaluating the safety and~     immunogenicity of AryoTrust™ vs. Herceptin®, are also the other secondary outcomes. This~     study has two arms and 108 subjects will participate with a 1:1 allocation and receive~     mentioned treatment randomly.~   "
10770|NCT03425851|"~     The adverse effects of poverty at the individual, family, and community level on health~     outcomes for children are well-established. Material hardship, defined as difficulty meeting~     basic needs such as food, housing, and consumer goods, has been shown to have negative~     physical and emotional effects on both children and their parents. Diaper need, defined as a~     lack of sufficient supply of clean and dry diapers, is an example of a material hardship.~      Community-based studies of low-income families have demonstrated that between 30-50% of~     caregivers of young children expressed diaper need. Some of these caregivers with diaper need~     reported reducing diaper changes, a practice that is associated with diaper dermatitis and~     urinary tract infections (UTIs). These community-based studies have also shown that diaper~     need is associated with maternal depression and parental stress, even after adjusting for~     demographic factors and food insecurity. Diaper need may be a specific modifiable marker of~     caregiver stress and depression, beyond its role as an indicator of poverty. In this pilot,~     randomized controlled trial of low-income newborns and their caregivers the investigators~     will test the feasibility of supplying diapers as an intervention to infants in low-income~     families and assess if it can improve both a child's health and their caregiver's overall~     health.~   "
10771|NCT03425838|"~     Given the uncertain benefit in efficacy of adding CDK 4/6 to first rather than second line~     endocrine treatment, the aim of this project is to evaluate whether the sequence of an~     aromatase inhibitor plus CDK 4/6 in first line followed by fulvestrant in second line is~     superior to the sequence of an aromatase inhibitor in first line followed by fulvestrant plus~     CDK4/6 in second line.~   "
10772|NCT03425825|"~     Non-interventional, retrospective study of advanced SCLC patients in 4 European countries~     (France, Germany, Italy, and United Kingdom [UK]) with the aim to produce evidence across~     different SCLC treatment lines to characterize the clinical and economic burden of the~     disease in Europe.~   "
10773|NCT03425812|"~     The multicenter, randomized controlled trial is to investigate and evaluate the effect of~     NSAIDs therapy on recurrence in patients with axial spondyloarthritis;~   "
10774|NCT03425799|"~     The purpose of this study is to see if Tranexamic Acid can safely reduce bleeding in people~     undergoing spinal fusion surgery.~   "
10775|NCT03425786|"~     The investigators are training a group of four pediatric Sports Medicine providers in BPPV~     maneuvers. All four providers will be trained in the diagnostic maneuvers, and two will be~     randomly selected to also be trained in the treatment maneuvers. The providers will be~     encouraged to use the diagnostic maneuvers on all new concussion patients whose initial visit~     is within 28 days of their injury. They will complete a survey at the start and end of the~     study to determine if they thought the training affected their understanding of BPPV and~     confidence in managing it, as well as determine any challenges they faced with~     learning/administering the maneuvers. Additionally, the investigators will determine if the~     additional training impacts time to recovery from concussion, as well as determine potential~     risk factors for BPPV in concussion.~   "
10776|NCT03425773|"~     BVAC-B is immunotherapeutic vaccine using B-Cell and Monocytes as antigen presenting cell.~     This study is Open-label, Accelerated titration, Multiple dosing study to evaluate the~     safety, tolerability, immune response and pre-efficacy of BVAC-B in patients with progressive~     or recurrent HER2/neu positive gastric cancer after failure to standard care. 9-27 patients~     will be enrolled.~   "
10777|NCT03425760|"~     This non-interventional study aims at assessing stable GOLD C and D COPD patient's perception~     of daily and weekly symptoms variability and their impact on daily activities.~      It will also explore the current practice in management of stable GOLD C and D COPD patients.~   "
10778|NCT03425747|"~     Hypoparathyroidism is an endocrinopathy characterized by a deficient secretion or action of~     PTH associated with low calcium level. According to the European guideline (2015), standard~     treatment includes oral calcium salts and active vitamin D metabolites to relieve symptoms of~     hypocalcaemia, maintain serum calcium levels in the low normal range and improve the~     patient's QoL Calcium carbonate is most often used and less expensive than other calcium~     preparations and contains the highest concentration of elemental calcium per gram (42%). It~     requires gastric hydrochloric acid to form carbonic acid (H2CO3) that immediately decomposes~     into water (H2O) and carbon dioxide (CO2). CO2 is responsible for its side effects such as~     flatulence, constipation and general gastrointestinal disorders. Therefore, in some patients~     it is better to find an alternative to calcium carbonate. Calcium citrate should be~     recommended to patients with achlorhydria or on treatment with proton pump inhibitors (PPI)~     as well as to patients who preferred to take supplements outside mealtimes.~      Up to now, there are no studies aimed to investigate the efficacy of calcium citrate in the~     management of subjects with chronic hypoparathyroidism. In particular, the Investigator will~     test the efficacy of calcium citrate in maintaining normal calcium level compared to~     carbonate calcium in subjects with chronic hypoparathyroidism. Moreover, the investigator~     will evaluate the impact of calcium citrate on QOL in this kind of patients compared to the~     gold standard therapy (carbonate calcium).~   "
10779|NCT03425734|"~     I. Study design: open/ blinded randomized, controlled study.~      II. Study setting and location:~      The study will be conducted in Abul Reesh Paediatric Hospital Faculty of Medicine /Cairo~     University from 2016-2018.~      III. Study population:~      This controlled open/blinded labelled randomized study is designed to include 40 children of~     both sexes scheduled for open-heart surgery for total correction of congenital heart~     diseases.~      IV. Eligibility Criteria:~      Inclusion criteria;~        1. Paediatric patients of age group ranging from 6 months to 12 years .~        2. Patients with complex congenital heart disease undergoing open heart surgery for total~          correction of the cardiac anomaly using cardiopulmonary bypass.~      Exclusion criteria;~        -  Age less than 6 months or more than12 years.~        -  Significant ventricular dysfunction (Ejection fraction < 40%).~        -  Patients with pre-existing CNS disorders e.g.: seizures.~        -  Patients with abnormal liver functions.~        -  Pre-operative creatinine level >1.2 mg /dl.~        -  Patients with history of diabetes mellitus.~        -  Patients receiving NSAID for any reason. Study Protocol; The patients will be~          pre-medicated by atropine 0.01mg/kg, ketamine 0.03mg/kg and midazolam 0.02mg/kg IM, 30~          minutes before induction of anesthesia. Standard ASA monitors, including~          electrocardiogram (ECG), pulse oximetry (Spo2), and non-invasive blood pressure cuff,~          and INVOS somatic oximeter probes will be placed on the renal area (on the back to the~          right or to the left from T10 to l2) will be placed on the patients before induction of~          anesthesia.~      Anesthetic technique will be standardized for all the patients in the form of inhalational~     induction using sevoflurane 6% in a mixture of oxygen and air (1:1) to be followed by~     placement of peripheral intravenous cannula. Intubation will be facilitated by pancuronium~     0.01 mg/kg IV and ventilation will be controlled using pressure mode aiming to maintain PCO2~     between (30-35 mmHg). Anesthesia will be maintained by mixture of 2% sevoflurane in 1:1~     oxygen: air till time of CPB.~      A standard CPB technique will be used in all patients. Before aortic cannulation, patients~     will receive IV heparin 400 U.kg-1 aiming to produce ACT value > 400 sec. A membrane~     oxygenator (minimax plus ;Medtronics Inc.,Anaheim,CA) will be used during CPB. Priming~     solution in the form of isotonic saline solution supplemented with heparin added to fresh~     whole blood in appropriate amounts to achieve a hematocrit 20-25% during CPB will be used.~     Furosemide in a dose of 1mg .kg-1.min-1 will be given to all patients. Venting of left heart~     will be performed with a left atrial vent inserted through a small incision at the~     inter-atrial septum . Anesthesia during CPB will be given by Sevoflurane administrated via a~     vaporizer inserted into the oxygenator gas supply with a constant gas flow 3 liter.min-1. A~     non-pulsatile roller pump (model10.10.00;Stocket instruments ;Munich, Germany) will be used~     and the pump flow will be adjusted at 2.4 to 2.6 L/min /m2 during the normothermic period~     targeting mean arterial blood pressure between 40 and 60 mmHg. If the MAP will fall below 40~     mmHg despite full perfusion pressure, a bolus dose of 0.01-0.1 ng /Kg phenylephrine will be~     given. If MAP increased above 60 mmHg, a continuous infusion of nitroglycerin at a dose of~     1-2 µg.kg.min-1will be given.~      After application of aortic cross clamp and administration of cold cardioplegia solution~     (Saint Thomas cardioplegic solution, 20ml/Kg to be followed by doses of 10ml/Kg every 20~     min.), time will be allowed to develop a stable level of perfusion pressure and moderate~     hypothermia (28°C-32°C).~      These variables will be kept constant for at least 10 minutes after initiation of full flow~     CPB and initiation of the study sequence. Thereafter, patients will be randomely allocated to~     DEX group (Group D n=20) receiving dexmedetomidine in a dose of 3 mcg/kg over 10 minutes to~     be followed by an infusion of 1 mcg/kg/hr to be continued until the first 6 postoperative~     hours.~   "
10780|NCT03425721|"~     This study will determine if HA dermal filler late occurring (> 4 weeks and <2 years) nodules~     are associated with bacterial contamination (independent of filler type) and to characterize~     the histological response.~   "
10781|NCT03425708|"~     To investigate the Effect of Hyperuricaemia on Chronic Renal Disease and Intervention~   "
10782|NCT03425695|"~     The present placebo-controlled parallel design clinical study was planned to determine the~     effect of low level laser therapy on clinical periodontal conditions and dimensions of free~     gingival graft as well as postoperative pain levels in the surgical area.~   "
10783|NCT03425682|"~     Assess clinical and radiographic outcomes in patients who undergo anterior cervical~     discectomy fusion (ACDF), transforaminal lumbar interbody fusion (TLIF) or posterior lumbar~     interbody fusion (PLIF) using ViBone.~   "
10784|NCT03425669|"~     Attention Deficit Hyperactivity disorder (ADHD) is one of the most frequent childhood~     disorders with an estimated prevalence of about 5-7% (e.g. Ullebo et al., 2012). Today the~     most common treatment approach is stimulant medication, e.g. methylphenidate (Greenhill et~     al., 2002; Wigal et al., 2011). However there are many concerns about medication: i) best~     dose for cognitive functioning and adapted school behavior differs (Hale et al., 2011), ii)~     it is not even evident that medication improves learning processes (Molina et al., 2009),~     iii) concerns regarding potential for drug abuse (Gordon et al., 2004); and iv) uncertainties~     regarding long term effects of drug use on the developing brain (Andersen, 2005).~      In both national and international guidelines of ADHD care multimodal treatment is~     recommended (Young & Amarasinghe, 2010), but most patients only receive pharmacological~     treatment, sometimes in combination with parent training. If auditory or vestibular noise, as~     the present project suggests, could be a complement or an alternative to stimulant medication~     it could fundamentally change the treatment of ADHD and the school situation for those~     children.~      2. Noise benefit in ADHD Auditory noise benefit: The original findings from our research~     group, that auditory noise enhances cognitive performance in inattentive children without~     diagnosis as well as children with an ADHD diagnosis, have been replicated several times~     (Baijot et al., 2016; Söderlund et al., 2016; Söderlund & Nilsson Jobs, 2016; Söderlund et~     al., 2007). In a new study, the benefit of noise was shown to be in parity with or even~     larger than the benefit of pharmacological ADHD treatment on two cognitive tasks, episodic~     word recall and visuo-spatial working memory task. In the study a group of children diagnosed~     with ADHD were tested on and off medication, at separate occasions, in noisy vs. silent~     environments while performing the tasks (Söderlund, Björk et al., 2016). Inattentive and low~     achieving school children have been shown to improve their memory recall when exposed to~     noise, whereas attentive and high achieving children perform worse during noise exposure~     (Helps et al., 2014; Söderlund & Sikström, 2008, 2012; Söderlund et al., 2010).~      Vestibular noise benefit: Vestibular stimulation has since long been demonstrated to increase~     hippocampal activity and hippocampus is well demonstrated to be of crucial importance in~     detecting and holding on to spatial targets showing that hippocampus is of fundamental for~     both spatial orientation and learning in general (Moser et al., 2015). Therefore it is not~     surprising that external stochastic vestibular stimulation (SVS) exerts beneficial effects in~     different domains, e.g. balance in healthy astronauts (Mulavara et al., 2011), in Parkinson~     patients (Pal et al., 2009; Samoudi et al., 2014) and response times in continuous~     performance task (Yamamoto et al., 2005). The theory about noise benefit is thoroughly~     described by Sikström and Söderlund (2007). 1. The first objective is to systematically~     evaluate the effects of stochastic vestibular noise on cognitive task performance and to~     compare these results with the ones of stimulant medication using a double blind RTC design.~      2. The second objective is to implement a practical application, to evaluate if auditory~     noise can be beneficial in an every day school setting by the use of an iPhone application~     (see: www.smartnoise.se).~      Participants and recruitment: Participants with an ADHD diagnosis using medication will be~     recruited from Child and Adolescent Psychiatry in Lund and Malmö. Typically developing~     children (TDC) and inattentive children without diagnosis will be recruited from schools in~     collaboration with the municipality.~      Experimental design: All participants will perform a double-blind placebo cross over control~     study. ADHD participants will perform the entire test battery at three occasions with 2-3~     weeks intermission in between tests. One occasion with placebo medication and sham SVS~     stimulation; one occasion with active SVS stimulation; and one occasion with active~     medication. TD children will only be tested twice while they will not be given any medication~     or placebo and just perform under SVS vs. sham conditions.~      Test battery: 1) Episodic memory will be tested trough Auditory Verbal Learning Test (AVLT)~     (e.g. Dige et al., 2008). 2) Visuo-spatial working memory will be tested through the~     Spanboard task (Westerberg et al., 2004). 3) Motor-neurological investigation. 4) A finger~     tapping task. 5) Evaluation of an iPhone auditory noise application in a normal school~     setting. Our research group has developed an iPhone application (www.smartnoise.se) that is~     available at App-store right now. The study will last for about 5 months and participants~     will be 50 voluntary secondary school pupils that have documented attention difficulties as~     judged by their teachers. The application will be evaluated both by pupils, teachers and~     parents.~   "
10811|NCT03425318|"~     The aim is to test a device for applying continuous negative abdominal pressure in patients~     with ARDS~   "
10932|NCT03423745|"~     This is a clinical study based on analysis of video-clip data of intubation and clinical data~     for cardiopulmonary resuscitation patients between 2011.03.01.-2012.02.28.. Aim of this study~     is to estimate the appropriate number of endotracheal intubation(ETI) experience for~     successful ETI at first attempt during cardiopulmonary resuscitation.~   "
10787|NCT03425630|"~     The aim of this study was to assess the lipid-lowering activity and safety of a dietary~     supplement containing monacolin K, L-arginine, coenzyme Q10 and ascorbic acid (vitamin C).~      Twenty both gender caucasian outpatients aged 18-75 yrs with serum LDL-C between130-180~     mg/dL, not significantly modified by an appropriate dietetic regimen assumed two different~     dietary supplements (Argicolina [trade mark]: A; Normolip 5 [trade mark]: N) both containing~     monacolin K 10 mg for 8 weeks each separated by a 4-week wash-out period in a single center,~     controlled, randomized, open-label, cross-over clinical study. Exclusion criteria were~     pregnancy or breast-feeding; known liver, renal or muscle diseases; serum triglycerides (TG)~     greater than 350 mg/dL; previous cardiovascular events; concomitant neoplastic or~     immunodepressive disease; use of lipid-lowering drugs or dietary supplements within the last~     three weeks; concurrent use of thiazide diuretics, oral contraceptives containing estrogen or~     progestogen, systemic corticosteroids; use of psycho-active substances, drug or alcohol~     abuse; neurological or psychiatric diseases that could affect consent validity or impair the~     patient's adherence to the study protocol. Evaluation criteria were Tot-C, LDL-C,~     HDL-cholesterol, TG, fasting blood glucose, aspartate aminotransferase, alanine~     aminotransferase, creatinkinase, gamma-glutamyl-transpeptidase, humeral blood pressure and~     heart rate measured at the start and a the end of each treatment period. Safety was monitored~     through the study.~   "
10788|NCT03425617|"~     The deleterious consequences of lung hyperinflation seem not to be restricted to the~     respiratory system in patients with chronic obstructive pulmonary disease (COPD). Cardiac~     function, in particular, is strongly influenced by changes in lung volumes and intra-thoracic~     pressures. In this context, strategies to reduce lung hyperinflation and the work of~     breathing can positively impact upon cardiac output and blood flow redistribution to~     peripheral muscles in these patients. There is growing evidence that combination of~     bronchodilators of different classes is an efficacious and safe strategy for further~     improving airflow obstruction and hyperinflation in patients with more advanced COPD.~     Therefore, we aim to investigate that, compared with placebo, a novel LABA/LAMA fixed~     combination (tiotropium 5 mcg plus olodaterol 5 mcg via Respimat® (Inspiolto®) (TIO/OLO)~     would decrease lung volumes at rest and during exercise, thereby improving: 1) central and~     peripheral hemodynamics and 2) arterial oxygenation, with positive consequences on skeletal~     muscle oxygenation and exercise tolerance in hyperinflated patients with moderate to very~     severe COPD.~   "
10789|NCT03425604|"~     Intrauterine insemination (IUI) is an ART that provides good results in selected patients,~     improving their reproductive prognosis. Endometriosis I y II, according to ASRM~     classification, remains an indication to perform IUI. This indication is on continuous~     debate, considering that different studies have shown controversial results about it, due to~     the poor reproductive outcomes in this group of patients~   "
10790|NCT03425591|"~     The purpose of this study is to describe the effectiveness of ibrutinib and to provide a~     description of ibrutinib therapy and the first non-ibrutinib subsequent therapy for chronic~     lymphocytic leukemia (CLL) and mantle-cell lymphoma (MCL).~   "
10791|NCT03425578|"~     Amino acids play an important role in human metabolism. In aging individuals and in some~     diseases, certain amino acids, such as glutamate, are at lower than normal levels. Glutamate~     appears to be involved in providing energy and maintaining normal blood sugar (glucose)~     levels, processes which both depend heavily on skeletal muscle. The maintenance of healthy~     blood sugar levels, in particular, is tightly related to overall muscle mass and quality. To~     better understand the link between glutamate and glucose metabolism in skeletal muscle, the~     investigators will be using a nutritional approach to raise the body's glutamate levels with~     monosodium glutamate (MSG) supplementation, and raise blood glucose levels with a sugary~     drink. By altering the normal levels of glutamate and glucose in the blood and muscle tissue,~     the investigators can gather more information about the role of glutamate in energy~     metabolism. This will help the design of future studies investigating the function of~     glutamate in aging and disease. During this study the investigators will increase the levels~     of glutamate and glucose in the bloodstream by asking participants to ingest MSG along with a~     sugary drink. The goal is to subsequently determine: A) the amount of glutamate and glucose~     that ends up in the muscle; and B) whether normal skeletal muscle glucose metabolism, and the~     behaviour of additional amino acids (other than glutamate) is altered. The hypothesis is that~     when MSG and sugar drink are ingested together glucose uptake and metabolism within the~     skeletal muscle will be elevated.~   "
10792|NCT03425565|"~     PEACOCC is a multi-centre, single arm, single stage phase II trial. The overall aim is to~     determine whether treatment with pembrolizumab is effective in patients with advanced clear~     cell gynaecological cancers.~   "
10793|NCT03425552|"~     This clinical study will compare the equivalence of two products containing Paliperidone 100~     mg in the form of a prolonged release suspension for injection in patients affected by~     schizophrenia who are already receiving this treatment. Each patient will receive both~     products (Test and Reference). In total, each patient will receive 10 doses (five doses of~     the Test product and five doses of the Reference product; one dose every 28 days).~     Furthermore, the two products (Test and Reference) will be compared with regard to their~     safety and tolerability.~   "
10794|NCT03425539|"~     This study aimed to determine the efficacy and safety of lucerastat oral monotherapy in adult~     subjects with Fabry disease.~   "
10795|NCT03425526|"~     If you are reading and signing this form on behalf of a potential participant, please note:~     Any time the words you, your, I, or me appear, it is meant to apply to the potential~     participant.~      The goal of this clinical research study is to learn if giving cytotoxic T lymphocytes (CTLs)~     can help to control adenovirus. Researchers also want to learn about the safety of giving~     CTLs to patients with adenovirus.~      CTLs are made from donated blood cells grown in the laboratory and are designed to kill~     viruses that can cause infections.~      This is an investigational study. The use of CTLs to treat adenovirus is not FDA approved. At~     this time, CTLs are only being used to treat infections in research studies.~      Up to 16 participants will be enrolled in this study. All will take part at MD Anderson.~   "
10796|NCT03425513|"~     The aim of this study was to evaluate the current prevalence and risk factors of hepatitis B~     virus (HBV) infection in a multi-ethnic neighbourhood situated in Middle Limburg, Belgium.~     Additionally, the investigators will determine linkage of care in hepatitis B surface antigen~     (HBsAg) positive subjects.~   "
10798|NCT03425487|"~     The aim of this study is to assess and compare the benefits of two psychological~     interventions added to the usual treatment of patients who come to mental health. Patients~     will be randomly assigned to the following conditions: Mindfulness-Based Stress Reduction~     (MBSR), Attachment-Based Compassion Therapy (ABCT) and a Treatment As Usual (TAU) Group. The~     participants in the two psychological intervention groups will also receive usual~     psychological/psychiatric treatment managed by their specialist. Mindfulness and Compassion~     groups will be composed of 30 participants each, and TAU group will be composed of 60~     participants (total sample n = 120).~      The principal hypothesis is that Mindfulness- and Compassion-based therapy + TAU will be more~     effective than TAU alone for treating anxious and depressive symptoms in clinical population.~     Secondary hypothesis, are: 1) Clinical patients who participate in Mindfulness-based therapy~     will obtain more significant improvements in the psychological variables than patients who~     only perform TAU. 2) Clinical patients who participate in Compassion-based therapy will~     obtain more significant improvements in the psychological variables than patients who only~     perform TAU. 3) Mindfulness- and Compassion-based therapies will be more cost-effectiveness~     than TAU.~   "
10799|NCT03425474|"~     The purpose of this study is to evaluate the safety and efficacy of the sedation for~     Remimazolam or Propofol in patients undergoing diagnostic upper GI endoscopy.~   "
10800|NCT03425461|"~     This randomized pilot phase I trial studies the side effects and best dose of anti-SEMA4D~     monoclonal antibody VX15/2503 when given together with nivolumab or ipilimumab in treating~     patients with stage III or IV melanoma. Monoclonal antibodies, such as anti-SEMA4D monoclonal~     antibody VX15/2503, nivolumab, and ipilimumab, may interfere with the ability of tumor cells~     to grow and spread.~   "
10801|NCT03425448|"~     Hemodialysis catheter related bacterial infections represent a major cause of mortality and~     morbidity in the hemodialysis population. Several locking agents had been tried with variable~     degree of success but not without side effects.~      Neutrolin catheter locking agent comprises of heparin,citrate and trauolidine that had been~     studied in a prospective study in Germany, and it demonstrated a very good result in terms of~     reducing the catheter related infections and thrombosis.~      This study is a multi-center, double-blind RCT comparing the hemodialysis catheter locking~     solution Neutrolin with heparin in reducing the rate of catheter related bacterial infection~     and thrombosis.~   "
10802|NCT03425435|"~     Medical care for patients with home parenteral nutrition (HPN) is challenging. Among other~     aspects, the transition from the inpatient to the outpatient setting (discharge management),~     the organization of HPN at home or in a care facility (care management), the expertise~     required to care for patients with HPN and consistent compliance with standards are key to~     the quality of care for patients requiring HPN.~      Hospital patients on parenteral nutrition (PN) to be continued at home are often discharged~     at very short notice. A good interlocking of all players is required to collect and~     distribute the relevant information, to secure proper training for those involved and to have~     all utilities and equipment at hand when the patient arrives.~      This study collects nutritional and clinical parameters (including patient-reported~     parameters) along the continuum of care of HPN patients to evaluate the impact of the quality~     of care of HPN patients on their quality of life.~   "
10803|NCT03425422|"~     A multi-center randomized controlled clinical trial to evaluate Autonomic Regulation Therapy~     with the VITARIA system in patients with symptomatic heart failure and reduced ejection~     fraction.~   "
10804|NCT03425409|"~     This study aims to investigate dose based oxygen delivery vs. continuous flow of oxygen~     during simulated altitude conditions as would be experienced after a loss of pressure during~     commercial aircraft flight. Testing will be performed at rest and during light exercise at a~     simulated altitude of 15,000 feet in a hypobaric chamber. Performance of the two oxygen~     delivery systems will be compared using oxygen saturation determined by pulse oximetry.~   "
10805|NCT03425396|"~     The purpose of this study is to evaluate the safety and efficacy of oral omadacycline as~     compared to oral nitrofurantoin in the treatment of female adults with cystitis.~   "
10806|NCT03425383|"~     Chronic inflammation plays a crucial role in the genesis of atherosclerosis and at the same~     time promotes acute cardiovascular events. Periodontal and pulpal inflammation are two major~     low grade chronic inflammatory infectious disease of oral cavity. Apical periodontitis is an~     inflammatory process, most often chronic in nature, of endodontic origin usually occurring at~     or near apex of the tooth root. The scientific literature has failed to provide the potential~     connection between endodontic infection and CV risk. Few studies have found the possible~     association, yet few studies does not suggest any link. The association between chronic~     inflammatory lesions and endothelial dysfunction can be detected using inflammatory, invasive~     and non-invasive markers. Inflammatory markers such as hs-CRP and Interleukins are not cost~     efficient and invasive markers- Angiography and Plethysmography are unethical to use on~     asymptomatic subjects. Non-invasive markers such as Flow mediated dilatation (FMD) and~     carotid intima media thickness (c-IMT) are inexpensive, fast and safe. The rationale of our~     study is to check the possible association between endodontic infection and CVD using~     non-invasive markers.~   "
10807|NCT03425370|"~     Surgery wounds are typically closed with combination of absorbable stitches placed under the~     skin and non-absorbable stitched placed at the skin surface. Absorbable sutures can produce~     unwanted side effects when the body produces a reaction to them. The investigators are~     conducting a study to determine if absorbable stitches can be replaced but tissue glue~     applied on the surface of the skin. If participants enroll in the study, the investigators~     will close one half of the participants wound with absorbable stitches placed under the skin~     and non-absorbable stitches on the surface. The other half of the wound will be closed with~     non-absorbable stitches and tissue glue. The appearance of the scar (if any) will then be~     evaluated at 3- and 6-month follow-ups by two dermatologists (either board-certified~     dermatologists or dermatology residents) and the patient.~   "
10808|NCT03425357|"~     This study aims a determine the responsiveness of sonoelastography in the~     tendinopathy-affected supraspinatus tendon.~   "
10809|NCT03425344|"~     This study aims at testing the discriminative validity of strain elastography in the normal~     and abnormal/pathological Supraspinatus tendon due to tendinopathy~   "
10810|NCT03425331|"~     This research study is studying two immunotherapy drugs as a possible treatment for advanced~     non-small cell lung cancer (NSCLC).~      The drugs involved in this study are:~        -  Ipilimumab~        -  Nivolumab~   "
10812|NCT03425305|"~     Serum uric acid level is a commonly measured biomarker. The association between serum uric~     acid level and the risk of developing cardiovascular diseases has been observed in some~     studies, while others showed controversial results. Estimation of this association may help~     to predict cardiovascular outcomes and may guide new treatment strategies. The hypothesis is~     that increased serum uric acid level is associated with a range of cardiovascular diseases.~   "
10813|NCT03425292|"~     The purpose of this study is to test the safety and tolerability of nivolumab or nivolumab~     plus ipilimumab when used following surgery and before standard therapy with radiation and~     temozolomide in patients with newly diagnosed glioblastoma.~      Additional aims of the study are to:~        -  Find out side effects (good and bad) of nivolumab and ipilimumab.~        -  Evaluate any preliminary evidence of anticancer activity of nivolumab and ipilimumab.~        -  Evaluate tumor characteristics by collecting brain tumor tissue samples.~        -  Measure the amount of nivolumab and ipilimumab in biospecimens.~        -  Look at biomarkers in biospecimens.~   "
10814|NCT03425279|"~     The objective of this study is to assess safety and efficacy of CAB-AXL-ADC in solid tumors~   "
10815|NCT03425266|"~     The investigators seek to understand the preferences, goals, and perspectives of patients~     with chronic pain and their health care providers (HCPs) to create a patient-centered~     decision support tool. This tool, aimed at patients and HCPs, should improve patient-provider~     communication and chronic pain management. The investigators' long-term goal is to improve~     the quality of life of patients with chronic pain. The investigators target adults with~     chronic unremitting pain and HCPs who manage patients with chronic pain, including primary~     care providers and pain specialists.~      A pilot randomized controlled trial (RCT) will measure the impact of a new online tool that~     the investigators developed (Pain-APP) in a representative sample of adults with chronic~     pain, including approximately 50 patients and 4-15 HCPs. Eligible patients will be enrolled~     online, and after informed consent and eliciting baseline socio-demographic information,~     randomized online to either Pain-APP or the control group, which will consist of online~     educational materials at the ACPA website (https://theacpa.org/Communication-Tools). Patients~     in both groups will be assessed online before, just after viewing the intervention materials,~     just after the index clinic visit, and 1 month later. Patient-reported outcomes include~     patient-provider communication, pain intensity and interference, attitudes towards and use of~     opioid medication.~   "
10816|NCT03425253|"~     This study has been designed to evaluate the safety and effectiveness of sequential treatment~     with BELKYRA® (for the treatment of convexity and fullness associated with submental fat) and~     VOLUMA™ (to restore volume along the mandibular border) to enhance the overall contour of the~     jawline.~   "
10817|NCT03425240|"~     The purpose of this study is to evaluate the feasibility of electrical stimulation of nerves~     responsible for erectile function to evoke penile erection after surgery to remove the~     prostate (prostatectomy).~   "
10818|NCT03425227|"~     A pilot six-week randomised controlled trial was carried out introducing biofeedback with~     physiological constants as follows: systolic blood pressure, diastolic blood pressure, heart~     rate and blood oxygen saturation in the intervention group.~   "
10819|NCT03425214|"~     Up to 50% of Narcolepsy-cataplexy (NC) patients suffer from REM sleep behavior disorder~     (RBD), a parasomnia.~      A strong link was found between RBD and impulse control disorders (ICD) in Parkinson disease~     (PD) patients. ICD are thought to be related to a dysfunction of meso-cortico-limbic pathways~     which belong to the so called ''reward system''.~      A recent study in IRMf shows that RBD is associated with impaired reward system.~      A strong link was found between these two disorders and therefore we believe that RBD is~     associated with impaired reward system in NC~      The main objective of this study is to evaluate differences in brain activation between NC~     patients with and without RBD.~      The investigators hypothesize that NC patients with RBD have a more severe dysfunction of the~     reward system (hypoactivation of the meso-cortico-limbic pathway) than patients without RBD.~   "
10820|NCT03425201|"~     Cabozantinib is an oral, small-molecule tyrosine kinase inhibitor. Its primary targets are~     Hepatocyte growth factor receptor protein (MET), vascular endothelial growth factor receptor~     1-3 (VEGFR1-3), RET, AXL, FLT3 and KIT. Cabozantinib has been approved by the FDA for~     clinical treatment of progressive, metastatic medullary thyroid cancer. Recently published~     trials have demonstrated activity for cabozantinib in patients with advanced renal cell~     carcinoma and metastatic castration-resistant prostate cancer (mCRPC). Furthermore, in~     preclinical models of urothelial carcinoma (UC) of the bladder, cabozantinib has demonstrated~     the ability to inhibit tumor xenograft growth. It has been suggested that levels of soluble~     Met ectodomain (sMet) can be measured in the urine as a useful biomarker to monitor the~     efficacy of c-Met therapy in bladder cancer patients. Moreover, cabozantinib has demonstrated~     activity in heavily pretreated, advanced bladder cancer patients, with a response rate of~     19.5% and manageable toxicities.~      In the phase I of this study it is proposed to evaluate DLTs of niraparib and cabozantinib~     combination and determine maximum tolerated dose (MTD) in patients with advanced urothelial~     or renal cell carcinoma. In the phase II it is proposed to make a preliminary evaluation of~     the efficacy of this combination in patients with urothelial cell carcinoma. Efficacy results~     will be correlated with genomic alterations related to c-Met and Poly [ADP-ribose] polymerase~     (PARP) inhibitor activity.~   "
10821|NCT03425188|"~     Prospective, single arm cohort study to evaluate the long-term safety, long-term~     effectiveness, and survival rate in subjects implanted with the remedē System.~   "
10822|NCT03425175|"~     In september 2017 audio recording during laparoscopic general surgery was implemented as~     routine a Lindesbergs hospital. The study was designed to observe operations before and after~     the introduction of audio recording. The main outcome of the study was time spent on~     non-relevant conversation.~   "
10823|NCT03425162|"~     Percutaneous nephrolithotomy (PNL) is frequently used today for renal stones. percutaneous~     nephrolithotomy (PNL) procedure has become the treatment of choice for many patients with~     symptomatic renal stones . Patients undergoing PNL suffer from acute postoperative pain,~     despite a multimodal analgesic regime.~      This is a randomised controlled trial efficacy of the anterior Quadratus Lumborum Block (QLB)~     in terms of analgesic efficacy in patients who undergo percutaneous nephrolithotomy.~   "
18817|NCT03320629|"~     The purpose of this study is to assess the efficacy and safety of patients who receive~     apatinib plus radiotherapy and S-1 for treatment of refractory or metastatic esophageal~     squamous cell carcinoma.~   "
10824|NCT03425149|"~     In this Phase 1 study, two target dose levels of VLA1601, a purified, inactivated, whole Zika~     virus (ZIKV) vaccine candidate adsorbed on aluminum hydroxide (alum) will be evaluated: 6~     antigen units (AU) and 3 AU of inactivated ZIKV vaccine. Each dose will be administered~     intramuscularly (i.m.) in the deltoid muscle on Days 0 and 28. In addition, an accelerated~     2-dose vaccination schedule on Days 0 and 7 will be assessed for both doses.~   "
10825|NCT03425136|"~     Optimizing the prevention of mother-to-child HIV transmission cascade minimizes drop offs~     from one step to the next to maximize the benefits of antiretroviral therapy on maternal~     health and pediatric survival, growth, and development. This proposal scales-up a health~     systems intervention (the systems analysis and improvement approach - SAIA) that packages~     systems engineering methods (including cascade analysis, flow mapping, and continuous quality~     improvement) and was previously shown to be effective in improving the prevention of~     mother-to-child HIV transmission cascade. By spreading the SAIA through routine district~     management structures, and studying the implementation process, this study will build~     evidence on how to achieve rapid, sustainable and scalable improvements in services that can~     dramatically improve population health in resource limited countries.~   "
10826|NCT03425123|"~     In this clinical trial the investigators will evaluate an alternate treatment option, which~     was developed for teeth with incomplete roots, called Regenerative Endodontic Procedure~     (REP). This treatment works by harnessing the blood clot formed within the root canal from~     tissues surrounding the root as a scaffold for stem cells. These cells could help to increase~     the thickness and length of the root canal walls resulting in root end maturation.~      Results from the 50 participants who will receive the REP treatment will be compared with~     findings with historical data.~   "
10827|NCT03425110|"~     The Modified Ketogenic Diet for the Treatment of Pharmacoresistant Epilepsy in Adults: an~     Observational Cohort Study~   "
10828|NCT03425097|"~     The investigators wish to study the effectiveness of Fexofenadine (an over the counter~     allergy pill) for the treatment of gastroesophageal reflux symptoms in patients who still~     have symptoms despite being on a proton pump inhibitor. The investigators will do this by~     giving participants both Fexofenadine (an H1 blocker) for 2 weeks and placebo (sugar pill)~     for 2 weeks. The participants will not know which drug they are getting at a particular time.~     This will help the investigators better assess the true effectiveness of Fexofenadine.~   "
10829|NCT03425084|"~     The main objective of the trial is to investigate the effect of known genetic variants in~     organic cation transporter 1 (OCT1) on the effect of morphine after major surgery~   "
10830|NCT03425071|"~     Therapeutic drug monitoring (TDM) of immunosuppressive drugs is used to improve the~     immunosuppressive effect while minimizing the toxicity related to exposition to high serum~     levels. Although TDM is widely used in clinical practice, a significant number of kidney~     transplant recipients have acute allograft rejection in the first year after transplantation.~     To improve the use of immunosuppressive drugs, new approaches of TDM have been developed.~     Monitoring drug concentrations at lymphocytes of peripheral blood is considering promising~     because it indicates the availability of the drug directly in the target sites of~     immunosuppression. The present study intends to establish the concentration profile of~     tacrolimus in the peripheral blood in parallel with the concentration profile inside T and B~     lymphocytes of peripheral blood of kidney transplant recipients, and correlates them with the~     expected pharmacological effects. The pharmacological effects of tacrolimus in calcineurin~     dependent and calcineurin independent (mitogen-activated protein kinase (MAPK) dependent)~     activation pathways will be assessed by measuring activated nuclear factor of activated T~     cells (NFAT) and p38, respectively, by flow cytometry. The expression of interleukin (IL) - 2~     and IL-10 by T and B lymphocytes, respectively, will be also used to monitoring the~     pharmacodynamic effects of tacrolimus.~   "
10831|NCT03425058|"~     Gastric cancer (GC) is a leading global health problem and is the third most common cause of~     cancer related death. Neoadjuvant chemoradiotherapy (nCRT) followed by surgery is the~     mainstay treatment for locally advanced gastric cancer, and variable degrees of tumor~     regression are observed after nCRT. Treatment strategies, including close surveillance~     without immediate surgery, have been investigated to spare patients with complete tumor~     regression from potentially adverse outcomes of radical surgery. However, clinical and~     radiological assessment of treatment response does not deliver an ideal accuracy of patients~     identification with complete response. In the present study, we focused on the clinical~     courses of patients who have developed locally advanced gastric cancer, and investigated the~     potential clinical utility of the detection of deficient MMR(dMMR), microsatellite~     instability(MSI) status and the decreasing level of circulating tumor cells (CTCs) and~     circulating tumor DNA (ctDNA) as promising biomarkers for the diagnosis and prediction of GC~     during treatment progress. Twenty milliliters of plasma were collected at 3 time points:~     before nCRT; after 2 cycles of nCRT; and after surgery. Firefly ctDNA NGS assays were used to~     track ctDNA mutations previously characterized in paired tumor tissue by massively parallel~     sequencing (MPS). We investigated whether circulating tumor DNA (ctDNA) detection can reflect~     tumor response to nCRT and detect minimal residual disease(MRD) after surgery. We compared~     CTC and ctDNA levels to clinical, radiological and pathological assessment modalities for~     nCRT response. The results will provide lots of information which may contribute to promote~     the treatment of GC patients. We want to introduce these strategies into clinical practice if~     possible.~   "
10832|NCT03425045|"~     Therapy of subjective chronic primary tinnitus could be challenging. Repetitive transcranial~     magnetic stimulation (rTMS) is currently being tested for suppressing the symptoms. However,~     effect of stimulation remains controversial. The aim was to uncover real effect of rTMS~     stimulation for tinnitus treatment. There will be three groups, stimulation group, sham~     stimulation group and controlled group with medicament treatment. The investigators assume~     that combination of rTMS stimulation of dorsolateral prefrontal cortex and primary auditory~     cortex at both sides will be more efficient. The investigators considered a 10% improvement~     in the tinnitus questionnaire score and in the tinnitus masking to be clinically relevant.~   "
10933|NCT03423732|"~     The main objective of the CIRCULATE project is to compare the clinical outcomes of CardioCell~     administration in treatment of ischemic damages of cardiovascular system with control group,~     who will be treated by the administration of placebo during the sham procedure.~   "
10833|NCT03425032|"~     Computed tomography represents the mainstay for diagnosing various diseases in the whole~     body. Over the past decade, enormous efforts were undertaken by both CT manufacturers and~     radiologist to reduce the radiation dose to patients. Today, the dose is significantly lower~     that it was before the era of multislice CT and iterative reconstruction methods. The X-ray~     beam originating from the tube in a CT system contains a spectrum of different energies,~     whereby the harder beams with higher energy penetrate the patient better, and the softer~     beams will be absorbed through the patient's tissues. Recent research has been shown that the~     radiation dose can be further reduced by improved primary beam filtering in CT. This study is~     intended to compare the radiation dose in clinically indicated, routine CT examination while~     maintaining a diagnostic image quality, on a new CT system with modified primary beam~     filtering.~   "
10834|NCT03425019|"~     The purpose of this study is to determine the feasibility and preliminary efficacy of two~     weeks of self Transcranial Direct Current Stimulation (tDCS) for pain in older patients with~     knee osteoarthritis (OA).~   "
10835|NCT03425006|"~     This is a single center, single arm phase 2 study to establish the safety and efficacy of~     itacitinib (also known as INCB039110) administered in combination with pembrolizumab in~     patients with metastatic PD-L1 positive non-small cell lung cancer (NSCLC).~   "
10836|NCT03424993|"~     The purpose of this study is to determine the effects of dietary salt restriction on central~     hemodynamics and vascular function in men and women with salt resistant blood pressure.~   "
10837|NCT03424980|"~     This is a real-world non-interventional observational study. The study was designed to~     evaluate the effectiveness and safety of clinical treatments in the patients with advanced~     non-small cell lung cancer (NSCLC) complicated with brain metastases in clinical practice.~   "
10838|NCT03424967|"~     This study examines whether the ability to extract statistical properties from the~     environment among treatment-seeking patients with social anxiety disorder can predict~     therapeutic response to attention bias modification (ABM), namely, reduction in symptoms of~     social anxiety following ABM therapy.~   "
10839|NCT03424954|"~     Each year a large number of patients undergo ileostomy surgery, a procedure in which a~     portion of the small intestine is attached to a hole in the abdominal wall, allowing for~     digested material to pass into a disposable bag worn attached to the skin. Ileostomies are~     performed for the treatment of a variety of diseases of the intestinal tract, such as~     inflammatory bowel disease, intestinal trauma, and gastrointestinal malignancy. Of the~     patients that undergo ileostomy surgery, 36% will require urgent medical care within the~     first 30 days of surgery. Most frequently, this is a result of dehydration due to excessive~     ostomy output. Thus, there is potential for significant improvement of the post-operative~     outcomes of ileostomy patients. Implementation of an automated text messaging system,~     EpxOstomy, can provide a way of monitoring patient's daily ostomy output and allow for timely~     intervention if output is outside normal limits, providing an effective way of improving~     patient outcomes while simultaneously reducing healthcare costs.~   "
10840|NCT03424941|"~     The trial objective is to investigate whether Fractional Flow Reserve (FFR)-Guided~     Percutaneous Coronary Intervention (PCI) and TransCatheter Aortic Valve Implantation (TAVI)~     strategy for treatment of multivessel disease and aortic stenosis will be non-inferior to~     Coronary Artery By-pass Grafting (CABG) and Surgical Aortic Valve Replacement (SAVR) for a~     composite primary endpoint of all-cause mortality, stroke, myocardial infarction, coronary or~     valve re-intervention and life-threatening or disabling bleeding at one year.~   "
10841|NCT03424928|"~     Pomalidomide capsule were developed to offer an alternative to the marketed formulation, This~     pilot study was aim to pre-assess the bioequivalence of the capsule formulations under fasted~     condition.~   "
10842|NCT03424915|"~     This study is designed to find out how engaging in regular exercise (or not) alters the~     biology of breast tumors as well as the normal tissue surrounding the tumor. The~     investigators hope that findings from this initial study will guide the design of future~     studies to examine how changes in exercise alter breast tumor biology.~   "
10843|NCT03424902|"~     The presence of aortic regurgitation (AR) jet from the aorta into the left ventricle is the~     most common complication after TAVI, occurring in about 70% of patients but usually trivial~     or mild (4, 5). In most previous studies, mild AR was not associated with a significantly~     shorter survival time (4, 5); however, the PARTNER trial demonstrated that it may be~     associated with worse long-term prognosis (3).~      Significant AR (moderate and severe) is less common, occurring in approximately 15-20% of~     cases(6), and is considered one of the most important prognostic factors of mortality during~     short- and long-term follow-up (7, 8). It is, therefore, essential to understand the~     mechanisms and risk factors associated with the occurrence of AR in order to minimize its~     incidence .~      Significant PVL most commonly results from(9):~        1. Incomplete prosthesis apposition to the native annulus due to calcification or annular~          eccentricity~        2. undersizing of the device and/or~        3. malpositioning of the valve . These observations seem to be true for both~          balloon-expandable and self-expandable THVs.~      However there are some new predictors which may correlate to occurance of paravalvular~     leakage including :~        1. Eccentricity of aortic valve calcification.~        2. Characterization of aortic annular calcification.~        3. Associated mitral annular calcification.~        4. Angle of LVOT to ascending aorta measurement (LVOT-AO).~        5. The depth of implantation of valve in relation to aortic cusps.~   "
10844|NCT03424889|"~     Flexible bronchoscopy is a commonly performed procedure and is usually performed~     transnasally. The optimal topical anesthesia regimen for bronchoscopy is investigational.~     Topical Vasoconstrictors like xylometazoline produce decongestion of nasal mucosa and may~     make insertion of bronchoscope easier. The addition of topical vasoconstrictor to lignocaine~     may have advantage in terms of patient comfort and for reducing local complications. Although~     evaluated in the settings of nasal endoscopy and nasotracheal intubation, randomized trials~     on the role of topical vasoconstrictors during flexible bronchoscopy are not available. The~     aim of this randomized trial is to study the effect of topical nasal xylometazoline~     administration during flexible bronchoscopy.~   "
10845|NCT03424876|"~     To compare the efficacy of surgery followed by sunitinib with surgery followed by imatinib in~     GIST patients with progression on imatinib;To investigate the optimal therapy after surgery~     in GIST patients with focal or multifocal progression in imatinib~   "
10846|NCT03424863|"~     Patients with an aortic stent graft are recommended to do muscle strengthening exercise as~     part of their rehabilitation. But, as excess blood pressure pose a risk to the integrity of~     the stent graft, high intensity muscle strengthening exercise may potentially be detrimental,~     and hence moderate intensity muscle strengthening is recommended. However, the blood pressure~     changes during moderate intensity strengthening exercises are unknown, and this study aims to~     quantify these among patients and compare them to those of healthy volunteers.~      Purpose:~      The purpose of this study is to investigate the increase in blood pressure during quadriceps~     muscle strength training in patients with aortic stent graft.~      Methods:~      Patients with aortic stent graft will be included. The participants are investigated once.~     During the investigation, the blood pressure increase during a single strength training~     exercise (leg press) is measured. The strength training exercise is done at 60% of maximal~     strength (moderate intensity) corresponding to 15 Repitition Maximum (RM) (a load that can be~     lifted exactly 15 times).~   "
10847|NCT03424850|"~     The purpose of this research study is to learn more about the outcomes and early and late~     side effects of treating early stage prostate cancer with high dose rate brachytherapy.~   "
10848|NCT03424837|"~     This is a parallel group, multisite prospective clinical study. The purpose of this study is~     to evaluate whether ASCENT enables patients to adhere to the survivorship guidelines and~     improves coordination of care to address patient needs.~   "
10849|NCT03424824|"~     Proof of concept study evaluating in alcohol use disorder, the ability of psychosocial~     support in combination with BP1.3656 to reduce alcohol consumption. The study will be a~     multicenter, randomized, double-blind, placebo-controlled phase II trial with parallel groups~     to evaluate the effectiveness and the safety of BP1.3656.~   "
10850|NCT03424811|"~     The high prevalence of mealtime difficulties and obesity among children with autism spectrum~     disorder (ASD) calls for new and innovative ways to promote healthy eating and weight~     development in this population. This project aims to develop and test an interactive mobile~     health (mHealth) nutrition intervention, which incorporates core behavior change strategies~     that have been empirically tested in family-based nutrition research and behavioral~     interventions with children with ASD. The feasibility and efficacy of this mHealth~     intervention to improve dietary outcomes in children with ASD will be tested in a~     proof-of-concept randomized controlled trial.~   "
10851|NCT03424798|"~     This is a feasibility study of the use of a novel technique called 'Inspiwave' to measure~     heart and lung function in adult patients in critical care.~      The preliminary work has already been undertaken in animal models and in healthy volunteers.~     The ultimate aim of this study is to develop a clinical tool for measuring (and therefore~     being able to make treatment changes based on) indices of heart and lung function in critical~     care patients. This study is the first assessment of the technique in this population, and~     whilst we know it works in patients undergoing general anaesthesia, we now need to assess~     whether Inspiwave can be used at all in critical care patients who may have much more~     physiological derangement. The purpose of this phase of the research is to determine whether~     it is feasible to use Inspiwave in critical care.~      Inspiwave generates a sinusoidally modulated tracer gas signal in the inspired air. It also~     measures the resulting signal in the expired air. The unique handling of this signal by the~     patient can used be to derive key variables related to cardiopulmonary function such as lung~     volume, pulmonary blood flow, the deadspace (wasted ventilation) and the degree to which~     ventilation and blood flow are non-uniform. These are 'vital signs' in sick patients, yet are~     currently technically difficult to measure, particularly non-invasively.~   "
10852|NCT03424785|"~     The study evaluates outcomes of intramural hematomas after long-term follow up and establish~     predictive factors in Chinese population.~   "
10853|NCT03424772|"~     To assess the indications and diagnostic efficiency of whole genome sequencing (WGS) in~     pediatric patients with unexplained intellectual disability/developmental delay, multiple~     congenital abnormalities and other rare and undiagnosed diseases~   "
10854|NCT03424759|"~     EGFR (ErbB1) mutations define a lung cancer subtype with exquisite sensitivity to EGFR~     tyrosine kinase inhibitors (TKIs). While in-frame deletion in exon 19 (Del19) and a point~     mutation (L858R) in exon 21 are the two most common sensitizing EGFR mutations in NSCLC,~     approximately 10% of EGFR mutation-positive tumors harbor uncommon mutations.~      These mutations represent a heterogeneous group of rare molecular alterations (or~     combinations) within exons 18-21, whose oncogenicity and sensitivity to EGFR TKIs may vary~     and has not been prospectively studied. Recently, a retrospective analysis reported that~     overall response rate of EGFR TKI (gefitinib or erlotinib) treatment was about 10% or less in~     Korean NSCLC patients with uncommon EGFR mutation other than del19, L858R and T790M [11]. In~     preclinical data, the potency of AZD9291 against uncommon EGFR mutants other than exon 20~     insertion mutation was fairly good.~      Based on the result, in this study, we try to evaluate the efficacy of AZD9291, the potent~     irreversible inhibitor, in NSCLC patients with harboring uncommon EGFR mutations.~   "
10855|NCT03424746|"~     This is a Pilot Trial Using Chelation Therapy for Limb Preservation in Diabetic Patients with~     Critical Limb Ischemia.~   "
10856|NCT03424733|"~     Some of the most common side effects of the multiple sclerosis drug Plegridy (pegylated~     interferon beta-1a) include flu-like symptoms and injection site reactions. Physicians often~     advise patients to take Tylenol or aspirin prior to injection, but in this study the~     investigators evaluated whether using a low dose of oral steroid in combination with Tylenol~     reduced flu-like symptoms and injection site reactions.~   "
10857|NCT03424720|"~     The aim of this comparative analysis is to evaluate the reliability of PLE value as an~     anesthetic depth indicator~   "
10858|NCT03424707|"~     A Single-Center, Randomized, Double-Blind, Parallel, Pilot Study to Evaluate the Efficacy and~     Safety of Fixed Dose Combination of Pelubiprofen/Eperisone in Patients with Acute Low Back~     Pain~   "
10859|NCT03424694|"~     The purpose of this study is to evaluate High-dose rate (HDR) brachytherapy (1 vs 2 fractions~     on single implant) as monotherapy for the treatment of low risk and intermediate risk~     prostate cancer~   "
10968|NCT03423277|"~     To research the use of a novel set of intraoral tools called the Easy Stretch Toolkit for the~     therapeutic management of facial burns and other facial disorders.~   "
37418|NCT03076866|"~     It is a prospective follow-up. The aim is to study the maintenance of therapeutic at 10 years~     and 20 years of inflammatory rheumatism (rheumatoid arthritis and spondyloarthritis)~   "
10860|NCT03424681|"~     Alcohol use disorder (AUD) is a major cause of morbidity and mortality and more treatments~     are needed, especially pharmacotherapies. There are a variety of efficacious treatments for~     AUD, but effect sizes are small, and vary from study to study. Medications may be more~     effective if particular subgroups of AUD are targeted. Identifying the mechanisms of action~     of a particular medication will help identify the subtypes more likely to respond to therapy.~     Global impulse control is a rational treatment target, and improving it is a likely~     mechanisms by which some medications for AUD work, especially in subtypes of AUD with~     impaired impulse control at baseline. Modafinil is a medication that is FDA approved for the~     treatment of narcolepsy, and is relatively safe and tolerable. There is reason to believe it~     may improve impulse control, and underlying neural circuitry, and may work best to improve~     alcohol use outcomes in AUD with poor impulse control. The overall aim of this study is to~     investigate the effects of modafinil on task performance and the integrity of neural circuits~     mediating response inhibition in treatment-seeking AUD with poor response inhibition, to~     establish target engagement. Secondary aims are to measure whether target engagement mediates~     improvement in alcohol use outcomes, and to utilize machine learning to identify neural and~     behavioral markers which best predict treatment outcomes. Twenty-four individuals with AUD~     and impaired response inhibition will be enrolled in the study, randomized to modafinil or~     placebo, and treated for 6 weeks. Functional magnetic resonance imaging brain scans during a~     response inhibition task and during rest will be obtained at baseline and 2 weeks. Aversive~     stimuli will be included in the response inhibition task to assure that efficacy generalizes~     to several conditions. Diffusion imaging and arterial spin labeling sequences will also be~     obtained. Investigators predict that modafinil will significantly increase brain activity in~     the medial and lateral prefrontal cortex during response inhibition, thereby establishing~     target engagement, and that it will improve alcohol use outcomes. Findings will provide~     information about whether or not a larger R01 trial investigating the efficacy of modafinil~     for individuals with AUD and impaired response inhibition is warranted.~   "
10861|NCT03424668|"~     The European Prospective Investigation into Cancer and Nutrition in Norfolk is a population~     based prospective study of approximately 25,000 men and women resident in Norfolk United~     Kingdom. They were aged 39-79 years when first recruited from general practice age sex~     registers at baseline assessment 1993-1997. While part of a ten country half million~     participant European collaboration originally aimed to investigate diet and other lifestyle~     determinants of cancer, the objectives of the Norfolk cohort from inception were expanded to~     encompass the trajectory of health, ill health and mortality in a population over time and to~     examine the biological and lifestyle determinants of health and chronic disease.~   "
10862|NCT03424655|"~     The goal of this research was to relate the occurrence of post-endodontic pain after~     single-visit RCT using Balanced Force technique and three reciprocating system when AP is~     conserved. Methodology: All 224 patients had upper or lower molar, premolar or anterior teeth~     selected for conventional RCT for prosthetic reasons detected with only vital pulps. Of the~     sample of 224 teeth, 56 were selected to the 4 instrumentation methods. For hand~     instrumentation, Balanced Force were used. All canals were clean and shaped with hand Flex-R~     files (fMoyco/Union Broach, York PA, USA). For mechanical shaping, all instruments were used~     with a micro motor (VDW, Munich Germany). Twisted files adaptive, WaveOne and Reciproc~     instruments. Final irrigation with cold (6oC) 17% EDTA served as a lubricant.~   "
10863|NCT03424642|"~     Relationship between mother and child starts to develop during pregnancy and continues after~     birth. Drug abuse, depression, very young or old age, weak social network, mothers´ own~     negative experiences from childhood's relationships and fear of birth may weaken the normal~     development of maternal-fetal bonding during pregnancy. Gestational weeks 24-32 are crucial~     in the point of maternal-fetal bonding. Ultrasound examinations during pregnancy have shown~     to strengthen the early relationship between mother and fetus in every trimester, to diminish~     mother's anxiety, to improve mothers bonding to child and to guide mother towards healthier~     lifestyle. Mental images awaken emotional relationship to the child. It is possible to~     prevent the interference of the gestational process of forming mental images and to diminish~     the negative effects of gestational stress to the child by intervention, that further~     prevents the problems of the baby's first year. Psychological intervention, that supports the~     interaction between mother and child, combined to gestational ultrasound examination has not~     investigated before in pregnant women with risk to preterm birth, depressive symptoms or~     other mental symptoms.~   "
10864|NCT03424629|"~     This is a study in patients with moderate to severe chronic plaque psoriasis.All the~     participants will be randomized into three groups, high-dose UC-MSCs, low-dose UC-MSCs, or~     methotrexate group.This study is designed to prove that UC-MSCs is safe and effective.~   "
10865|NCT03424616|"~     Nucleus accumbens plays important roles in the process of opiate addiction and initial of~     relapse after detoxification.According to the single-centered preliminary open-labeled~     prospective trial results, the investigators hypothesize that bilateral stimulation of the~     NAc will effectively reduce the relapse of the opiate dependence.~   "
10866|NCT03424603|"~     First-in-human Phase 1 trial to study the safety, pharmacokinetics and preliminary efficacy~     of STRO-001 given intravenously every 2 weeks.~   "
10867|NCT03424590|"~     Clearblue Connected Ovulation Test System (COTS) has been designed for home use by women who~     are either planning or trying for a pregnancy. This study will determine the difference in~     pregnancy rate of female volunteers seeking to get pregnant who use COTS in comparison to~     those not using an ovulation product to assist with conception.~   "
10868|NCT03424577|"~     This study will be conducted to determine the effect of food on the relative bioavailability~     of H3B-6527 following administration of a H3B-6527 capsule with and without a meal.~   "
10869|NCT03424564|"~     This study will be conducted to evaluate the pharmacokinetics of perampanel following single~     and multiple oral doses in Chinese healthy male and female participants.~   "
10870|NCT03424551|"~     The aim of this study is to demonstrate whether whole body vibration-induced muscle activity~     is a reflex response in patients having spasticity due to the spinal cord injury.~      Hypotheses of this study: Unlike healthy cases, in patients with spastic spinal cord lesions~        1. Local vibration-induced tonic vibration reflex response disappear~        2. The the whole body vibration- induced reflex muscular response disappear~   "
10879|NCT03424434|"~     Regarding 30 to 50% of occupational blood exposure (OBE) are underreporting among health~     professionals, it's to highlight that the part of medical professionals in OBE reporting is~     among the lowest (1996 to 2016). The current study is aiming to evaluate the underreporting~     of this specific occupational accident among medical staff for the year 2017. The~     investigators are supposing this is declining and the part of OBE reporting is better than~     before. So the current situation concerning OBE underreporting for medical staff in an~     University Hospital Center (UHC), 20 years after the first study, is our main purpose.~   "
11528|NCT03415906|"~     The autonomic nervous system plays an important role in controlling the circulation.~     Increased sympathetic activity has detrimental effects in patients with heart failure.~      The purpose of this study is to test the hypothesis that combined angiotensin receptor +~     neprilysin inhibition results in lower sympathetic activity than angiotensin receptor~     inhibition alone.~   "
10871|NCT03424538|"~     Abstract Introduction: Postural control disorders are the most common motor disorder~     associated with multiple sclerosis.~      Objective: The aim of this study is to demonstrate the potential for improvement of postural~     control, motion performance and quality of life in patients with multiple sclerosis who are~     performing a special neurorevolutionary balancing program.~      Intervention: The treated group (n = 15) performed five times a week for the treatment we~     defined. (60 minutes per day). The experimental group performed movements using the Xbox 360~     and Kinect consoles. The study team participated in 25 sessions, five times a week. The~     duration of treatment was 5 weeks.The MStp group (n=14) participated in a 5-week~     physiotherapy course. The general treatment consisted of strengthening, stretching and~     walking correction. During the 5-week period, 25 patients attended training. One treatment~     takes 60 minutes. Sensory Organisation Test / Body Sway at the end of the baseline and~     treatment protocol is used to evaluate each patient. The quality of life mapping was measured~     by subjective tests (EQ-5D-5L, ADL). To assess the depressive state, a Beck depression~     questionnaire was used. Balance and motion performance were used by the Berg Balance Test and~     6Minutes Walk Test. The results were compared with the control group results (n = 14) and~     showed improvement in overall balance and motion performance.~   "
10872|NCT03424525|"~     Patients with suspected bacterial infection at the time screening are eligible for this~     study. Patients may participate in this study if they are at least 18 years of age, and most~     participants will be receiving care at the clinical practices of the University of~     Pennsylvania. Up to 30 subjects will participate in two different imaging cohorts.~      The Biodistribution cohort will include up to 5 patients referred from orthopedics who will~     undergo a series of vertex to mid-thigh (or feet if indicated) biodistribution~     [11C]trimethoprim PET/CT scans over a period of approximately 2 ½ hours.~      The Dynamic cohort will include up to 25 patients who will undergo approximately 60 minutes~     of dynamic scanning followed by up to 2 static skull base to mid-thigh (or feet if indicated)~     scans imaging post injection of [11C]trimethoprim. Some subjects who may be selected~     clinically to undergo surgical or antibiotic treatment may undergo a second therapy may also~     undergo an optional second [11C]trimethoprim PET/CT after the initiation of therapy to~     collect pilot data on the changes in [11C]trimethoprim biodistribution and uptake with~     therapy, the timing of this scan may vary depending on the type of treatment the patient is~     receiving.~      Patients will also undergo baseline lab tests complete blood count (CBC), C-reactive protein~     (CRP), erythrocyte sedimentation rate (ESR) and blood cultures. If these tests are done as~     part of clinical standard of care they will not need to be repeated for this study.~   "
10873|NCT03424512|"~     This study aims to test the potential of group metacognitive therapy in alleviating emotional~     distress in cancer survivors. The investigators aim to find out if a group based approach is~     acceptable to patients and feasible to deliver in a routine clinical health psychology~     service.~   "
10874|NCT03424499|"~     The objective of the study is to determine whether single-use polyvinylchloride (PVC)~     catheters reduce urinary tract infections (UTI) compared to reused PVC catheters for patients~     with neurogenic bladder due to spina bifida that require intermittent catheterization for~     bladder emptying. The investigators conducted a randomized parallel clinical trial with an~     8-week follow-up comparing single-use and reused (washed with soap and water, and stored in a~     container with benzalkonium chloride) PVC intermittent catheterization. Evaluations were~     established at days 0, 7, 14, 28, 42 and 56. Participants reported symptoms and urine culture~     results, collecting urine samples from a fresh midstream catheter specimen using sterile~     technique.~   "
10875|NCT03424486|"~     The Impact of cystic fibrosis (CF) on psychological and emotional functioning has been the~     focus of several studies over the past 20 years. The results from a current meta-analysis~     indicated that depressed patients were three times more likely to be noncompliant with~     treatment recommendations than nondepressed patients with chronic illness.~      To date, most studies of the prevalence of psychiatric symptoms have been limited by small~     sample size; reliance on samples of convenience that are potentially biased in term of rates~     of symptomatology, and measures that contain legitimate symptoms that are part of the~     respondent's chronic disease. Estimating the prevalence of depression and anxiety has become~     important as new evidence indicates that these symptoms may have a significant impact on~     health outcomes, including adherence to medical treatments, utilization of health care~     services, and rates of morbidity and mortality. More depressive the symptoms are associated~     with poorer lung function, and that in the absence of depression, poor lung function is~     minimally associated with lower patient ratings of quality of life.~      The purpose of the current study is to estimate the regional, and if possible the national~     prevalence of depressive and anxious symptoms in children and adults with CF and parents~     caregivers. Patients with CF ages 14 to 17, and parents of children ages 14 to 17, will~     complete and depression/anxiety screening measure at a routine clinic visit. These will then~     be linked with demographic and medical variables reported to the CF registry and analyzed~     cross sectionally. Adults with CF ages 18 and older will also complete the depression /~     anxiety screening measure at a routine clinic visit. Efforts will be made to recruit a~     representative sample of patients from each clinic.~   "
10876|NCT03424473|"~     Physicians interested in requesting a single patient IND should contact Cascadian~     Therapeutics at EAPrequest@CascadianRX.com~   "
10877|NCT03424460|"~     Investigators identified a high risk of deep vein thrombosis and pulmonary embolism in~     patients presenting myotonic dystrophy type 1 treated in our hospital, 10 times higher than~     general population matched on age and sex. These venous thromboembolic events were frequently~     severe and lethal.~      Investigators suspect that this high risk of venous thromboembolism is due to coagulation~     abnormalities specific to myotonic dystrophy type 1.~      The purpose of this study is to determine: 1/ if there is a hypercoagulable state in myotonic~     dystrophy type 1 by testing patient's coagulation, and 2/ if genes encoding factors involved~     in coagulation have modified expression resulting in this hypercoagulable state.~      Understanding the pathophysiology will help preventing venous thromboembolism in these~     patients.~      It is the first study to describe this specific issue.~   "
10878|NCT03424447|"~     The purpose of the study is to determine the impact of the efferent loop stimulation of a~     loop ileostomy prior to closure on postoperative complications such as ileus and hospital~     stay~   "
40096|NCT03041896|"~     To evaluate clinical, radiologic and patient-reported outcomes who have been treated 1 or 2~     levels with the coflex® Interlaminar Technology or decompression with or without fusion.~   "
10880|NCT03424421|"~     The arthroscopic subscapular sling procedure is a new technique for shoulder stabilization,~     which has been developed in human cadaveric studies by Klungsøyr et al, but has yet to be~     tested clinically. The procedure stabilizes the shoulder by using a semitendinosus graft that~     makes a new labrum and a sling around the subscapular tendon. Extensive biomechanical robotic~     testing of the procedure shows significant less translation and thus better stability of the~     humeral head with the sling compared to a normal Bankart repair. The investigators consider~     the biomechanical results after robotic testing sufficient to advocate a planned pilot study~     in humans. In this pilot study the clinical and radiological results of the sling will be~     investigated in a small number of cases. The safety of the subscapular sling procedure will~     be assessed. This studies results are expected to be a further step towards implementation of~     the sling procedure as a surgical option for shoulder instability.~   "
10881|NCT03424408|"~     Some aspirin-treated patients have a blunted pharmacological response predisposing to~     clinical failure. The investigators hypothesize that the blunted response often results from~     increased rate of platelet production and some failures will be prevented by administering~     aspirin twice daily. The overall objective is to develop a valid method to quantify platelet~     production (without the use of radioactive isotopes) in order to examine the hypothesis that~     enhanced platelet production is a common cause of poor aspirin responsiveness in patients~     with atherothrombosis.~   "
10882|NCT03424395|"~     The objective of this study is to determine the impact of an integrated personalized dietary~     and wellness program which includes dietary advice, meals, and counseling on health and~     wellness.~   "
10883|NCT03424382|"~     This study occurs in two phases. Phase 1 involves initial item development and measurement~     validation of a new tool for identifying hospitalized patients at high risk for preventable~     readmission. Primary tasks include item construction and content validation, data collection,~     analysis, and instrument refinement. Phase 2 involves administering the refined instrument to~     a new group of patients to determine final item content for the instrument, its factor~     structure, and its predictive validity.~   "
10884|NCT03424369|"~     The regular opening of the eustachian tube plays an important role in maintaining normal~     pressure in middle ear cavity, hearing function and preventing the occurrence of middle ear~     inflammation. The current evaluation of Eustachian tube function mainly depends on the~     patient's history of auricular distention, occlusion, physical examination (Valsalva),~     acoustic impedance test. However, these tests can not accurately assess the eustachian tube~     function, the lack of quantitative analysis of eustachian tube function. Currently, surgical~     treatment of patients with chronic otitis media is one of the most important treatment~     methods. However, the current results show that some patients can not reconstruct the~     gas-containing structure of the middle ear after operation, which brings about the treatment~     of diseases and the recovery of auditory function Difficulties. Although domestic and foreign~     scholars believe that eustachian tube function in tympanoplasty in the reconstruction of the~     middle ear with air cavity plays an important role, but due to the lack of a reliable~     quantitative evaluation of eustachian tube function, eustachian tube function in the~     occurrence of chronic otitis media , There is a lack of reliable evidence-based medicine in~     the assessment of the value of development and prognosis. In recent years, a new eustachian~     tube function evaluation method - Eustachian tube manometry technique, began a quantitative~     objective assessment of Eustachian tube function, combined with physical examination and~     subjective symptom scales to conduct a comprehensive assessment of eustachian tube function .~     This study wants to evaluate the eustachian tube function preoperatively and postoperatively~     in patients with chronic otitis media who underwent surgery. Regular postoperative follow-ups~     were used to understand the importance of eustachian tube function in the prognosis of~     chronic otitis media surgery , In order to further improve the eustachian tube function and~     improve the surgical curative effect of chronic otitis media.~   "
10885|NCT03424356|"~     Cystoscopy is a simple, effective and reliable method in current urological practice.~     Anesthesia may be required in cystoscopy for therapeutic purpose, however it may not be~     necessary for diagnostic cystoscopy. General anesthesia, spinal anesthesia, epidural~     anaesthesia and senile block methods may be performed in therapeutic cystoscopy.~      Pain is main reason of failed cystoscopy. Sedo-analgesia and LMA are generally used for~     diagnostic cystoscopies. LMA is mostly placed under general anesthesia with the combination~     of propofol-fentanyl and volatile anesthetics. There is no need for muscle relaxant~     administration in LMA placement, as it is necessary for intubation. However if muscle~     relaxant is not used, side effects like hiccup, straining, cough, undesirable muscle~     movement, hypoxia and laryngeal spasm may be observed.~      For the improvement of the patient comfort the use of effective muscle relaxants are~     described in several studies in literature. This study aimed to reveal the quality of~     anesthesia, hemodynamics, surgical comfort, extra propofol need and recovery time while low~     dose of muscle relaxant rocuronium was added to propofol-fentanyl combination for LMA~     placement.~   "
10886|NCT03424343|"~     The study investigators plan to conduct a longitudinal questionnaire study in adolescents and~     emerging adults (14-25 years of age at the start of the study) who survived childhood cancer~     to chart their identity development and broader social functioning. Additionally, the~     functioning of these survivors will be related to the functioning of their parents and~     siblings. The investigators shall focus especially on the current experience and impact of~     the earlier cancer experience. They will investigate to what extent the experience of a~     life-threatening disease has an effect on the daily life of survivors and over time and how~     the survivors develop through the course of adolescence and emerging adulthood on the~     psychosocial level. The formation of an adult identity is a very challenging task during~     adolescence and the way to adulthood and the fact that these youth had cancer during their~     childhood may especially complicate this process of identity formation. Furthermore, both~     parental and sibling functioning will be taken into account, which will allow us to examine~     inter-generational mechanisms (thus parental functioning that possibly impacts youth~     functioning and vice versa) and sibling functioning in these families. To investigate the~     latter, at each timepoint of the longitudinal study a sibling between 14 and 25 years of age~     at the start of the study will be included (if there is more than one sibling in a family,~     ideally the sibling who is closest in age will be the one who participates in the study).~     Moreover, a community sample that is matched on age and sex with the survivor of pediatric~     cancer will be assessed. This will allow the investigators to make well-founded comparisons~     regarding identity development and broader psychosocial functioning.~   "
10887|NCT03424330|"~     The study aims to evaluate the safety, usability and efficacy of the ReX-C - a novel~     medication management system - in measurement and improvement of adherence, in patients~     receiving oral anti-coagulation therapy for the treatment and prevention of thromboembolism.~   "
10928|NCT03423797|"~     The objective of this study is to compare the effectiveness of 25% AgNO3 solution plus 5% NaF~     varnish and 25% AgNO3 solution plus 5% NaF varnish with fTCP when applied semi-annually over~     30 months in arresting dentine caries of primary teeth among preschool children. Half of~     Participants will receive topical application of 25% AgNO3 solution and 5% NaF varnish, while~     the other half will receive topical application of 25% AgNO3 solution and 5% NaF varnish with~     fTCP.~   "
10888|NCT03424317|"~     The aim of this study was to evaluate the therapeutic effect of sodium intake reduction by~     education in patients with resistant hypertension.~      The study was designed to maximize the compliance to antihypertensive agents and use optimal~     doses of antihypertensive agents including diuretics for 2 months before randomization.~     Patients will be assigned randomly to receiving (1) education of sodium intake reduction and~     exercise, or (2) education of exercise alone. Education of sodium intake reduction will be~     blinded to patients, and education of exercise will be provided to both group to blind the~     subjects. Daytime ambulatory blood pressure is adopted for diagnosis of resistant~     hypertension to avoid white-coat effect.~   "
10889|NCT03424304|"~     Evaluate the Cutera excel V™ Laser with Green Genesis and a Micro-Lens Array (MLA) Attachment~   "
10890|NCT03424291|"~     The purpose of this study is to confirm the safety and efficacy of Apatinib in Combination~     With Radiotherapy / Chemotherapy for Second-line and Above Recurrent / Metastatic Head and~     Neck Squamous Cell Carcinoma.~   "
10891|NCT03424278|"~     This is a randomized controlled trial project to analyze the effectiveness of lumbar motor~     control exercises and lumbar resistance training on pain, functional, kinesiophobia and trunk~     strength in individual with chronic low back pain. The project has two parallel arms and will~     be supervised by physiotherapists (motor control exercises) and physical education~     professionals (resistance training). The participants will be Militaries of the Military Fire~     Department of the Federal District who presents in the recruitment regular low back pain more~     than 3 months. The two groups will be supervised in12 weeks of exercises in the Physical~     Activity Center of Military Fire Department of the Federal District. Our hypotheses is that~     the resistance training effects wil be superior to motor control exercises only for trunk~     strength (isokinetic flexion and extension).~   "
10892|NCT03424265|"~     The investigators will examine the effects of 12-weeks of nutritional interventions in older~     participants who have a symptom of mild to moderate heart failure.~   "
10893|NCT03424252|"~     Two parts, two periods, crossover study with part 2 is optional. In both parts, subjects will~     be randomized to sequentially receive both sublingual and oral formulations of FDL169.~   "
10894|NCT03424239|"~     This study evaluates whether zoledronic acid can prevent the high bone turnover that occurs~     after Roux-en-Y Gastric Bypass (RYGB) surgery.~   "
10895|NCT03424226|"~     This double blind randomized trial will compare acetazolamide taken the morning of ascent to~     acetazolamide taken the evening prior to ascent for the prevention of acute mountain sickness~     (AMS). The day of ascent dosing has not been studied as a powered primary outcome. The study~     population is hikers who are ascending at their own rate under their own power in a true~     hiking environment at the White Mountain Research Station, Owen Valley Lab (OVL) and Bancroft~     Station (BAR), Bancroft Peak, White Mountain, California~   "
10896|NCT03424213|"~     Data from evaluating prostate cancer (PCa) biopsy tissue from AA and white patients has led~     to the discovery of alternative splicing as a novel molecular mechanism underlying more~     aggressive PCa in AA men. Coded archival radical prostatectomy tissue specimens and annotated~     clinical data, questionnaire data, and ancestral genotyping data will be obtained from the~     racially diverse and federally funded North Carolina-Louisiana PCa Project (NC-LA PCaP). We~     will use 33 tissue specimens from each of the following 6 groups (n=198 total): white low~     aggressive, white intermediate aggressive, white high aggressive, AA low aggressive, AA~     intermediate aggressive and AA high aggressive. The aforementioned tissues will first be~     screened for tumor content and Gleason grade by a genitourinary pathologist. To identify~     race-related splice variants, RNA will be isolated for targeted sequencing of prioritized~     race-related alternatively spliced genes using the NimbleGen SeqCap Target Enrichment, SeqCap~     RNA System to capture regions of interest and the Illumina HiSeq sequencing platform to~     sequence these regions at a depth and coverage sufficient to accurately call alternative~     splicing events.~   "
10897|NCT03424200|"~     One major study objective is, using 2 study arms (data-driven health coaching plus RC vs. RC~     only), to evaluate the efficacy of data-driven health coaching. 'RC only' will serve as the~     control group. Participants will be enrolled in the trial on the basis of an existence of~     objective cognitive impairment defined by the MCI Screen (MCIS) and being in one of three~     functional stages as defined by the Functional Assessment Staging Test (FAST). The three FAST~     stages correspond to cognitive impairment without functional impairment (FAST 2), cognitive~     impairment with functional impairment without impairment in instrumental activities of daily~     living (FAST 3, also known as mild cognitive impairment, MCI), or cognitive impairment with~     impaired instrumental activities of daily living (FAST 4). Study objectives include measuring~     treatment related changes in cognitive and functional abilities, quality of life, and~     biological or biochemical measures.~      A second major study objective is to analyze longitudinal multi-omic data from individuals on~     a trajectory of early-stage dementia, to discover correlations between measured variables,~     and identify models of causation that can further advance knowledge and research in brain~     degeneration and healthy living~   "
10898|NCT03424187|"~     Aims: To investigate the effects of different food structures on appetite signals from the~     upper gastrointestinal tract.~      DESIGN: A randomised, controlled, clinical trial.~   "
10899|NCT03424174|"~     Comparison of coated and uncoated TKA with regard to cytokine expression and clinical results~   "
10900|NCT03424161|"~     The objectives of this study are to evaluate the efficacy and safety of the Cutera Secret RF~     device.~   "
10901|NCT03424148|"~     Open-label, Prospective, Study to Evaluate the Cutera excel V laser at 532 nm in a low~     fluence, high repetition rate mode and the Micro-Lens Array attachment used with excel V~     laser at 1064 nm and 532 nm for the improvement of skin quality.~   "
10902|NCT03424135|"~     To evaluate the relative bioavailability of naproxen sodium/diphenhydramine hydrochloride~     (DHP HCL) 220/25 mg soft capsules (Test) versus naproxen sodium/DPH HCl 220/25 mg tablets~     (Reference) after a single oral administration (2 x naproxen sodium 220 mg and DPH HCl 25 mg~     combination product) under fed conditions in healthy adult subjects.~      To assess the safety and tolerability of the investigational products in terms of adverse~     events (AEs) and clinical parameters (systolic/diastolic blood pressure, pulse rate, physical~     examination, clinical and laboratory testing).~   "
10903|NCT03424122|"~     The purpose of this study is to evaluate the safety and tolerability of INCB050465 when~     combined with rituximab, bendamustine and rituximab, or ibrutinib in participants with~     relapsed or refractory B-cell lymphoma.~   "
10904|NCT03424109|"~     This proposal builds upon the evaluation of Primary Palliative Care Education, Training, and~     Technical Support for Emergency Medicine (PRIM-ER) implemented in 33 Emergency Departments~     (EDs). This is a retrospective cohort study that seeks to measure the effect of PRIM-ER on~     older adults with serious illness on aspects of: 1) ED disposition to an acute setting; 2)~     healthcare utilization in the 6 months following the index ED visit; 3) survival following~     the index ED visit; and 4) determine site, provider, and patient-level characteristics that~     are associated with variation in impact of PRIM-ER across sites.~   "
10905|NCT03424096|"~     The purpose of this cluster-randomized stepped wedge design is to test the effectiveness of~     primary palliative care education, training, and technical support for emergency medicine~     (PRIM-ER) in 35 Emergency Departments (EDs). PRIM-ER includes four core components: 1)~     evidence-based multidisciplinary primary palliative care education, 2) simulation-based~     workshops on communication in serious illness, 3) clinical decision support, and 4) provider~     audit and feedback.~   "
10906|NCT03424083|"~     Contribution of four pulmonary function tests to diagnosis in patients with respiratory~     symptoms in the primary care.~   "
10907|NCT03424070|"~     This study compares the distance from the operating table to the eye of the laryngoscopist~     while intubating the trachea with or without a shoulder roll. A photo of the glottic opening~     will compare the glottic views in both positions.~   "
10908|NCT03424057|"~     The aim of this study was to reduce the residual dead-space volume with a modification~     following the standard Karydakis procedure.~   "
10909|NCT03424044|"~     Closed-loop systems are an emerging technology that automate hormone delivery. They are~     quickly paving the way to revolutionize the treatment of type 1 diabetes. Several categories~     have emerged: dual-hormone (insulin and glucagon) closed-loop systems and closed-loop systems~     with insulin only, one variety of which is the low glucose suspend safety feature now~     available from Medtronic (MiniMed640G with SmartGuard). The study described within this~     protocol is designed to test the efficacy of a new closed-loop algorithm for managing blood~     glucose in people with type 1 diabetes before and after exercise. The new algorithm will have~     3 modes: a single hormone insulin only mode, a dual-hormone insulin and glucagon mode and an~     insulin only mode with predictive low glucose suspend, all with an exercise detection~     algorithm. The purpose of this study is to determine whether a dual hormone AP using a stable~     investigational glucagon with an exercise detection algorithm outperforms both single hormone~     AP and a low glucose suspend algorithm.~   "
10910|NCT03424031|"~     Functional recovery is one of the main issues in the management of stroke and there are~     various ways in rehabilitation to promote this recovery.~      Verticalization is a technique whose benefits have been widely demonstrated, particularly in~     neurology. Although commonly used in the rehabilitation of stroke, evidence is still lacking~     as to its impact in this specific care.~      Verticalization is underutilized in two situations: in the hyper acute phase as well as in~     elderly and very deficient patients. It has, however, been shown that the precocity of the~     treatment allows a better functional recovery. Similarly, the re-education of the elderly is~     also debated since it has long been mentioned that age was a factor of poor prognosis, the~     objectives are sometimes underestimated. However, several studies have shown that with the~     same rehabilitation, elderly patients recover as much as younger patients. The differences~     found are at least in part due to less rehabilitation of older stroke patients.~      The different existing data lead us to the hypothesis that the verticalization of the elderly~     hemiplegic patient in acute phase would allow a better functional recovery.~   "
10911|NCT03424018|"~     The intent and design of this Phase 3 study is to assess BMN 111 as a therapeutic option for~     the treatment of children with Achondroplasia~   "
10912|NCT03424005|"~     This is a Phase Ib/II, open-label, multicenter, randomized umbrella study evaluating the~     efficacy and safety of multiple immunotherapy-based treatment combinations in patients with~     metastatic TNBC who had disease progression during or following first-line metastatic~     treatment with chemotherapy.~      The study will be performed in two stages. During Stage 1, participants will be randomized to~     capecitabine (control) or an atezolizumab-containing doublet or triplet combination. Those~     who experience disease progression, loss of clinical benefit, or unacceptable toxicity may be~     eligible to receive a new doublet combination treatment in Stage 2 until loss of clinical~     benefit or unacceptable toxicity. New treatment arms may be added and/or existing treatment~     arms may be closed during the course of the study on the basis of ongoing clinical efficacy~     and safety as well as the current treatments available.~   "
10913|NCT03423992|"~     A pilot study to determine the safety and efficacy of chimeric antigen receptor T cell~     (autologous T cells transduced with a lentiviral vector expressing chimeric antigen receptor)~     personalized immunotherapy for patients with recurrent malignant gliomas based on the~     expression of tumor specific/associated antigens (EGFRVIII, IL13Rα2, Her-2, EphA2, CD133,~     GD2).~   "
10914|NCT03423979|"~     A prospective, non-randomized, feasibility study. The subjects will be enrolled and treated~     with the Optilume BPH Prostatic DCB Dilation Catheter System at up to 15 clinical sites. The~     post-treatment follow-up visit can be up to 5 years.~      The objective of the study is to evaluate the safety and performance of the Optilume™ BPH~     Prostatic Drug Coated Balloon Dilation Catheter System in the treatment of BPH.~   "
10915|NCT03423966|"~     The study sets out to determine the effect of smartphone pedometers on the body mass of~     overweight and obese clients at the general outpatient department, national hospital Abuja.~      It is a synopsis of the proposed dissertation submitted to the West African College of~     Physicians in partial fulfillment of the requirements for the part 11 Fellowship examination~     of the faculty of Family Medicine.~   "
10916|NCT03423953|"~     This data collection project is intended to provide clinical outcomes data to engineering,~     marketing as well as fulfill the post market surveillance requirements of various regulatory~     authorities. The study will be a prospective and one-arm.~   "
10929|NCT03423784|"~     Medical device study for efficacy and tolerability of a HA gel in the management of teething~     symptoms~   "
10930|NCT03423771|"~     Japanese male healthy volunteers will receive NPF-08. The efficacy of NPF-08 will be assessed~     by intestinal cleaning degree. The safety of NPF-08 will be evaluated based on adverse events~     and adverse drug reactions observed from the date of administration to 7 days after~     administration.~   "
10917|NCT03423940|"~     Background: Functional communication training (FCT) is a commonly used intervention for~     teaching appropriate communication skills to children with intellectual disabilities who~     exhibit severe destructive behavior. Resurgence as Choice (RaC) Theory, a quantitative model~     of behavior, may help to explain why treatment relapse often occurs after FCT. This project~     will use the predictions of RaC to improve FCT treatments.~      Objective: To test the predictions made by RaC with human subjects who exhibit severe~     destructive behavior.~      Eligibility: Children between the ages of 3 and 18 who display destructive behavior that is~     maintained by social consequences, who have IQ and adaptive behavior scores between 35 and~     70, who are on a stable psychoactive drug regimen (or drug free) for at least 10 half-lives~     of each medication with no anticipated changes, and who have a stable educational plan and~     placement will be be eligible to enroll.~   "
10918|NCT03423927|"~     This study aims to assess the impact of a group intervention combining self-hypnosis and~     self-care techniques on prostate patients' well-being. More specifically, the investigators~     want to investigate the effects of that intervention on sleep, fatigue and emotional distress~     of the patients.~   "
10919|NCT03423914|"~     Premature birth can lead the mother to lose control of herself, and be a contributor to the~     psychological stress experienced due to the sudden breakdown of the interaction with her~     infant because of hospitalization in a neonatal care unit. This is a mixed method study, the~     aim is establish the effectiveness of expressive writing in the experience of mothers of~     hospitalized preterm infants. The intervention Expressive writing therapy could contribute to~     reduce the level of stress and anxiety, improving coping and the mother's interaction with~     her infant.~   "
10920|NCT03423901|"~     It was previously suggested an improvement of graft survival in ABO/HLA incompatible kidney~     transplantation (KT) compared with HLA (human leukocyte antigen) incompatible~     transplantation. Here, the investigators would analyse clinical, biological and histological~     results of ABO/HLA incompatible kidney transplant recipients, comparing with ABO or HLA~     compatible kidney transplantation.~   "
10921|NCT03423888|"~     In palliative care, the relief of the dyspnea is necessary. Medications for the reduction of~     dyspnea have side effects. High-flow nasal cannula oxygen therapy (HFNC) is a new way to~     deliver oxygen. Investigators hypothesize that HNFC is an acceptable technic for the patient~     with dyspnea in palliative care.~      A pilot study with 30 patients will be conducted. Acceptability of HNFC will be studied by~     the time of use by patients of the HNFC during one week. The effectiveness of HNFC in~     relieving dyspnea will be studied using Borg scale.~   "
10922|NCT03423875|"~     Delirium is a common and serious complication of medical care that affects 10% of older~     Emergency Department (ED) patients, which unfortunately is unrecognized in up to 75% of ED~     patients.Studies have shown that 26 - 42% of patient with delirium are sent home. And 80% of~     patients sent home with unrecognized delirium are re-hospitalized within 4 days. Unrecognized~     delirium also has grave consequences for patient care - Kakuma showed that patient with~     unrecognized delirium who were sent home had 3-8x the mortality rate of patients with~     recognized delirium at 6 months.~      Fluctuating severity over time is a key clinical characteristics of delirium, making its~     diagnosis challenging. Regardless of cause, failure to recognize delirium means that ED staff~     cannot meet their patient‟s needs. For example, ED staff may miss serious medical conditions~     associated with delirium, may not provide understandable discharge instructions or ensure a~     caregiver can supervise and assist a patient with delirium who is discharged. These care~     adaptations require staff to recognize the presence of delirium. Thus it is not surprising~     that unrecognized delirium has such grave consequences for patients.~      Thus recognition of delirium is critical to improving patient outcomes and reducing repeat ED~     visits. Patients with delirium may appear to have normal mental status at times, making its~     diagnosis challenging. High levels of service demand in the ED, plus the competing demands of~     numerous other initiatives to improve quality and reduce waiting times may explain why~     delirium continue to go unrecognized despite guidelines promoting routine delirium screening~     as a top priority in the ED. To address this care gap, the investigators developed an~     innovative solution. Rather than adding tasks to overburdened ED staff, our solution takes~     advantage of the long waiting times clients have in the ED for their initial assessments and~     between interactions with clinical staff. During these times, patients will use the PrEDICT~     serious game - similar to the Whack-a-Mole carnival game. The investigators have developed~     an algorithm based on participants‟ performance on this simple but serious game that can~     identify patients at high risk for delirium.~      The investigators propose to conduct a prospective, multi-center randomized clinical trial in~     4 provinces. The primary objective of this study is to assess the impact of our tablet~     technology on the recognition of delirium by ED staff. All eligible patients who agree to~     participate will be treated in the same manner and will play the PrEDICT tablet based game.~     The investigators will randomly assign half of patients to have their test performance shared~     with clinical staff. Patients assigned to the control condition will be treated using the~     current standard of care, clinical assessments, to identify delirium.~      This project will allow us to solidly advance this technology from a working prototype (TRL7)~     to a commercially ready product demonstrated effective in multiple real-world environments~     under expected operational conditions (TRL8). Also it will provide evidence that the PrEDICT~     tablet app is clinically, technically, commercially and operationally feasible.~   "
10923|NCT03423862|"~     Investigators aim to further the understanding of the various factors that govern the~     progression of beta-cell death in individuals recently diagnosed with Type 1 diabetes (T1D).~     Specifically, the investigators wish to examine the utility of plasma-induced signatures and~     other measures as predictive biomarkers for the rate of C-peptide decline in individuals with~     recent onset T1D. Persistent C-peptide in individuals with T1D reflects some degree of β-cell~     function and is clinically associated with a reduction in both severe hypoglycemic events and~     microvascular complications such as diabetic nephropathy and retinopathy. There is~     significant heterogeneity in the rate of C-peptide decline in individuals with T1D,~     reflective of the complex disease process. For example, ~10% of individuals have no~     discernable fall in stimulated C-peptide after two years from clinical diagnosis as compared~     to other individuals with very rapid C-peptide decline. It is currently impossible to predict~     how long, and to what extent, someone will have residual C-peptide production. This~     complicates clinical management but also the design and interpretation of T1D β-cell~     preservation trials. The gold standard outcome measure of any T1D β-cell preservation trial~     is the stimulated C-peptide to a mixed meal tolerance test (MMTT). Given the variability in~     this measure, intervention studies must include more subjects over a longer period of time.~     This slows the rate of scientific discovery and increases cost. This study aims to define the~     governing mechanisms of post-onset T1D disease trajectory. Understanding the trajectory of~     the disease may lead to the development of biomarkers to predict disease progression and~     therapies that could reverse or prevent the development of Type 1 diabetes.~   "
10924|NCT03423849|"~     Worldwide, breast cancer is the most incident and prevalent cancer among women. Despite~     advances in the treatment of advanced breast cancer (ABC) during the past decade, adjuvant~     systemic therapy has yield little progression for such patients. ABC remains an incurable~     disease, responsible for approximate 40,000 deaths annually and a median life expectancy of~     no more than 3 years. The NCCN guidelines clearly define routine adjuvant chemotherapy~     regimens for the early breast cancer, however, for the patients with recurrence and~     metastasis, the choice of treatment options is not clear. In this trial, we choose the~     patients with disease progression who received anthracycline and taxane adjuvant chemotherapy~     after surgery. The patients received vinorelbine and gemcitabine (NG) or vinorelbine and~     platinum (NP) regiments for 6 cycles. Then the patients with complete response (CR), partly~     response (PR) and stable disease(SD) will be assigned to 3 groups, one group will receive the~     original regiment for 3 cycles to maintain treatment, one group will receive the vinorelbine~     for 6 cycles, the other group will receive the capecitabine for 6 cycles. Trasuzumab will be~     used to patients if HER-2 positive. Endocrine therapy will be used if the hormone receptors~     positive after the chemotherapy. The primary endpoint is to assess disease-free survival~     (DFS), the secondary endpoint is to assess the overall survival (OS).~   "
10925|NCT03423836|"~     The principal objective was to conduct a 5 year; multi-center, observational follow-up study~     enrolling infants born to mothers who participated in the MOTOR clinical trial to determine~     the effects of maternal periodontal therapy during pregnancy on neonatal morbidity and~     mortality and whether this will result in lower incidence of functional neurological~     impairment.~   "
10926|NCT03423823|"~     This is a randomized, open-label, interventional, controlled study to determine the effects~     of Zaltrap on Neovascularized Wet Macular Degeneration as compared to the control~     anti-vascular endothelial growth factor (anti-VEGF) injections (bevacizumab, ranibizumab,~     or aflibercept).~   "
10927|NCT03423810|"~     The purpose of this study is to find a protein (ex. Polycystin 1 or mucin and cadherin like~     protein) in the urine that is changed after treatment of hydralazine.~   "
18832|NCT03320434|"~     To evaluate the efficacy and safety of two concentrations of PRT-2761 as a topical ophthalmic~     solution for the treatment of the signs and symptoms of acute and chronic allergic~     conjunctivitis.~   "
10934|NCT03423719|"~     The purpose of this study is to evaluate the effects of a 16-week supplementation with a~     polyphenol-rich extract, Fiit-ns®, on improvement of health-related quality of life (HR-QOL)~     of overweight and obese volunteers, as compared to placebo. Previous beneficial results from~     a pilot study showed that the supplementation may improve quality of life as well as body~     composition. Based on such results, this pivotal study is statistically powered to detect~     significant differences in HR-QOL assessed with the Short Form-36 Health survey (SF-36)~     between baseline (Week 1, W1) and end of the supplementation period (Week 16, W16).~   "
10935|NCT03423706|"~     Building a new haploid transplanted model with high-dose CTX、CD19-CART,donor CD34+~     hematopoietic stem cell and Tregs,to prevent graft-versus-host disease(GVHD),reduce the~     infection,promote the rate of immune reconstruction，seperate graft versus leukemia（GVL）and~     GVHD，then to reduce the relapse rate after hematopoietic stem cell transplantation（HSCT）for~     relapsed and/or refractory B cell acute lymphoblastic leukemia（r/r-B-ALL）.~   "
10936|NCT03423693|"~     This study was designed as retrospective chart review to test our hypothesis whether there~     are the differences in inflammatory and anti-inflammatory mediators between asthmatic and~     ACOS patients with small airway obstruction, and COPD~   "
10937|NCT03423680|"~     This is an 8-week, multicenter, randomized, double blind, placebo controlled study to~     evaluate the efficacy and safety of aripiprazole as an adjunctive treatment with mood~     stabilizer for the treatment of patients (outpatients or inpatients) with type I or II~     bipolar disorder accompanied by major depressive episode, without any psychotropic features.~      This study involves patients who are considered by the investigator not to have a proper~     improvement, despite receiving a mood stabilizer (lithium or valproic acid) for a sufficient~     (≥ 28 days) period of time during the current depressive episode.~   "
10938|NCT03423667|"~     Cocaine abuse is associated with serious physical, psychiatric and social problems. Addiction~     results in the compulsive use of a substance with loss of control and persistence despite the~     negative consequences.The act of re-engaging in the search for drugs is called relapse and a~     particularly insidious aspect of addiction is that vulnerability to relapse lasts for many~     years after stopping drug use.~      The main reason why people continue to use cocaine is because of its influence on the reward~     system.Indeed, this substance makes it possible to increase the level of dopamine,~     particularly in the nucleus accumbens.This increase in dopamine is not related to the hedonic~     pleasure that consumption provides. Instead, it imprints a positive value to enhancers and~     facilitates the learning of reward associations through the modulation of the cortical and~     subcortical regions of the brain.In other words, it suggests that users become sensitive to a~     series of stimuli that combine with a rewarding feeling, which drives them to consume when~     they encounter them.~      N-acetylcysteine (NAC) has been used for a long time, mainly as mucolytic. It has also been~     used as a glutathione antioxidant precursor in the treatment of paracetamol overdose for more~     than 30 years. NAC has shown beneficial effects in animal models of cocaine addiction by~     reversing neuroplasticity and reducing the risk of restoring consumer behavior in rodents.~     Human studies show that NAC is potentially effective in preventing relapse in abstinent~     patients and ineffective in reducing current consumption.~      In this study the investigators will test a sample of newly detoxified (and therefore~     abstinent) patients who have taken a 3-4 week course of treatment, in order determine if NAC~     can be a useful medication candidate to avoid relapse in patients with cocaine dependence.~   "
10939|NCT03423654|"~     This study is designed to see if doing regular training on a spatial imagery task leads to~     improvements in the ability to do the trained spatial imagery task and in the ability to get~     around in everyday activities.~   "
10940|NCT03423641|"~     The investigators will assess whether patients with the Hepatitis C virus (HCV) who are~     prescribed direct-acting antiviral (DAA) medications experience higher rates of adverse~     events than patients with HCV who are untreated. The investigators hypothesize that patients~     receiving DAAs do not experience higher rates of adverse events compared to patients who have~     not received DAAs. The study population is adults between the ages of 18 and 88 with any~     indication of a diagnosis of HCV. An intervention group (those receiving a DAA) and~     comparison group (those who are not treated) will be created using medication dispensing~     data. Eligibility for the study will be determined from January 1, 2011 through December 31,~     2017. Covariates will be collected from January 1, 2011 through December 31, 2017. Individual~     study sites may have access to historical data prior to 2011 that can be used as covariates~     or to identify individuals with HCV. The primary outcomes of interest include acute~     myocardial infarction, neurological outcomes (e.g. acute stroke, intracranial bleed), acute~     kidney failure, acute on chronic liver failure, hepatic decompensation, multiple organ~     dysfunction syndrome, cancer, bradyarrhythmia, and death. The secondary outcomes include~     decompensated cirrhosis, hospitalization, emergency department visit, and arrhythmia.~     Outcomes will be assessed from January 1, 2011 through December 31, 2017. The investigators~     will use two different analytic approaches to answer the question of interest: a Poisson~     regression model and marginal structural modeling (MSM). The simpler Poisson model is an~     extension of tabular rate of event analysis. The more complicated MSM model incorporates~     modeling of the treatment decision to more flexibly control for confounding by indication.~     For each outcome, the investigators will only record the first date an outcome occurs. Each~     outcome will be modeled separately.~   "
10941|NCT03423628|"~     This study will test an investigational drug called AZD1390 in combination with radiation~     therapy for the treatment of brain tumors. This is the first time AZD1390 is being given to~     patients. This study will test safety, tolerability and PK (how the drug is absorbed,~     distributed and eliminated) of ascending doses of AZD1390 in combination with distinct~     regimens of radiation therapy.~   "
10942|NCT03423615|"~     School-aged children in low and middle-income countries (LMIC) face significant challenges to~     their health and development which contribute to poor academic achievement. Multi-component~     comprehensive school health programs guided by the World Health Organization's (WHO) Health~     Promoting Schools (HPS) framework have been shown to positively impact health outcomes. Such~     programs are implemented widely throughout the world. However, in LMIC the scope and reach of~     school health programs are limited by human resource constraints. A key challenge to~     effective implementation has been the identification of effective delivery agents.~      A potential alternative approach is to leverage existing community members as lay~     fieldworkers for the delivery of school health promotion. Our hypothesis is that~     lay-fieldworkers can effectively implement comprehensive school health programs in~     resource-constrained primary schools. This hypothesis will be tested by retrospectively~     analyzing data obtained during a 5-year pilot of a school health program (CHHIP) in rural~     primary schools of the Darjeeling Himalayas of India.~   "
10943|NCT03423602|"~     The purpose of this Clinical Investigation Plan (CIP) is to:~        1. Confirm the safety and performance of the PerQseal® large hole closure system.~        2. To expand its indications of use to include common femoral arteriotomies created with 12~          to 20 F sheaths in patients undergoing endovascular procedures.~   "
10944|NCT03423589|"~     Investigators aim to further the understanding of environmental factors that underlie the~     progression to Type 1 diabetes (T1D). Dysbiosis, defined as alterations in intestinal~     microbiota composition and function, has been hypothesized to increase the risk of developing~     T1D in those with genetic susceptibility. Dysbiosis may result from modern dietary habits,~     such as broad consumption of the highly processed Western Diet, or by widespread use of~     antibiotics. Here, investigators propose to examine the impact of dysbiosis on the endogenous~     innate inflammation known to exist within families affected by T1D and if probiotic~     supplementation may beneficially modulate this inflammatory state.~      Participants will be asked to take the probiotic VSL#3 daily for six weeks. Stool and blood~     samples will be analyzed before and after the six week course of probiotics.~   "
10945|NCT03423576|"~     For the Project VEMSE-CF, a comprehensive patient-centered outpatient health service model~     was developed offering focused interventions in different areas. These included patient~     education, as well as nutritional and exercise counselling. Special emphasis was given to the~     psycho-social services. The implementation was supported by a case manager. The model was~     implemented in three German CF-Centers. For evaluation, Patient data from 13 additional~     German CF-Centers offering standard care was used as comparison. In total, 153 patients in~     the Intervention Group and 163 control patients aged 5-52 years contributed data. The primary~     endpoint was the number of BMI- and FEV1-measurements over 24 months. Secondary endpoints~     included mortality, lung transplantation, FEV1, BMI, adherence to therapy, Quality of life,~     and mental stress.~   "
10946|NCT03423563|"~     Tracheal intubation is one of the most common medical procedures performed in hospitals. On~     one hand, it is highly successful and easy to perform using a rigid laryngoscope. On the~     other hand, hypoxic brain damage and death may result rapidly if it is unsuccessful. This~     disastrous outcome happens when the airway cannot be secured by intubation and face mask~     ventilation becomes difficult.~      Careful preoperative evaluation to identify patients in whom tracheal intubation and mask~     ventilation may prove to be difficult can save lives.~      Over the past 40 years, different techniques of tracheal intubation have been introduced, the~     most effective under different conditions being fiberoptic intubation.~      The flexible intubation video endoscope is a relatively new device which delivers clear,~     pixel-free images without a Moiré pattern. The flexible intubation video endoscope can be~     directly connected to the C-MAC® monitor. Due to the Distal Chip technology the user enjoys a~     full-format direct video imaging with improved image quality with a resolution higher than~     fiberoptic bronchoscopy which has another disadvantage of being Fragile where Fibres can be~     broken or have transmission loss when wrapped around curves of only a few centimeters radius.~      After ethics approval and informed consent from patients, 60 obese patients aging from 20-60~     years will randomly allocated and divided into two groups each is (Thirty) patients in each~     group, using flexible intubation video endoscope(FIVE) in (group1) and fiberoptic~     bronchoscopy in (group 2).~      The study will compare the techniques for time of intubation, hemodynamic (SBP, DBP and HR)~     changes, success rate, number of attempts and complications in both groups.~      investigators expect from this study that flexible intubation video endoscope(FIVE) has~     become a good alternative and associated with better visualization of laryngeal structures in~     shorter time as compared to traditional flexible fiberoptic bronchoscopy.~   "
10947|NCT03423550|"~     This study evaluates new technique for diagnosis of tuberculosis. Among patients who are~     suspected with tuberculosis, half of participants will be tested conventional method such as~     Xpert TB/RIF assay, while the other half will be performed new diagnostic technique using~     homobifunctionalImidoesters compounds.~   "
10948|NCT03423537|"~     The objective of this prospective randomized clinical trial is to investigate whether the~     addition of low-dose hCG to a short GnRH-agonist protocol for IVF and ovarian stimulation~     with rFSH from the onset of the follicular phase and throughout stimulation in sub fertile~     women undergoing IVF, improves pregnancy rates.~   "
10949|NCT03423524|"~     Prospective, non-randomised, open, controlled, single-center post-market clinical follow~     study about Micropure 1.2.3 IOL.~   "
10950|NCT03423511|"~     To compare MiStent to either the Xience or Promus stents.with the primary objective being to~     assess the safety and efficacy of the MiStent in a patient population requiring~     revascularization of de novo obstructive lesions of coronary arteries in patients with stable~     and unstable coronary artery disease (CAD) including non ST-Elevation Myocardial Infarction~     (NSTEMI)~   "
10951|NCT03423498|"~     The effectiveness of conservative treatment of hallux valgus deformity has not been~     sufficiently explored yet. The aim of this study was to assess the effect of the~     toe-spread-out exercise on the amplitude and frequency pattern in a surface electromyographic~     examination in patients with hallux valgus and in people without the deformity. An additional~     objective is the assessment of nerve conduction in an electroneurography and the assessment~     of range of motion in a clinical examination.~   "
10952|NCT03423485|"~     The purpose of this study is to evaluate the CG-100 device, a single use, temporary~     intraluminal bypass device,intended to reduce contact of fecal content with an anastomotic~     site, following colorectal surgery (open or laparoscopic)~   "
10953|NCT03423472|"~     This cluster randomized controlled trial will test the effect of the promotion of vitamin~     A-rich orange flesh sweet potato (OFSP) production and nutrition education on vitamin A and~     energy intake, including any added value of the Healthy Baby Toolkit.~   "
10954|NCT03423459|"~     The primary objective of this study is to evaluate the real-world performance of the~     CoreValve Evolut PRO transcatheter aortic valve, including leaflet function, in a prospective~     observational registry.~   "
10955|NCT03423446|"~     This study is designed to evaluate the effect of severe hepatic impairment on the~     pharmacokinetics (PK) of telotristat ethyl (TE) ( LP-778902 active moiety, metabolite),~     following administration of a single dose of TE 250 mg (1 x 250-mg tablet) compared to~     healthy, demographically-matched subjects with normal hepatic function.~   "
10969|NCT03423264|"~     Enrollment is only available to patients enrolled on the Optima II study (NCT03107182).~      The purpose of this trial is to compare rates of opioid use at completion of radiation for~     patients with Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 2 oral mucositis~     after receiving definitive nonoperative locoregional therapy with or without prophylactic~     gabapentin as part of best supportive care for locoregionally-advanced, HPV-related~     oropharyngeal cancer. Secondary purposes include comparison of total equivalent opioid dosage~     above baseline opioid use at end of treatment, quality of life metrics, swallowing function,~     feeding tube dependence, and protocol compliance in patients managed with best support care~     with or without prophylactic gabapentin. Rates of gabapentin-related side effects and~     discontinuation will also be investigated.~   "
11713|NCT03413501|"~     Patients who fulfilled inclusion criteria and consented to participate received either~     treatment as usual at the clinic, or were enrolled in a group-therapy based intervention, the~     multi-disciplinary pain intervention, led by a Medical doctor, physiotherapist and~     psychologist at the clinic.~   "
10956|NCT03423433|"~     Physical inactivity and increased sedentary time are linked to increased blood pressure and~     may cause decreases in peripheral and cerebral oxygen perfusion in stroke survivors.~     Nonetheless, stroke survivors are significantly less active than their healthy counterparts~     due to physical incapability or a lack of confidence in physical capability. This study will~     determine whether a simple and non-demanding movement such as repeated heel raises are able~     to cause acute and chronic decreases in peripheral and central blood pressure and increases~     in oxygen perfusion and cognitive performance.~      Thirty participants will be recruited to this study. All will take part in four sessions. One~     familiarisation session will acclimatise participants to the equipment used involving central~     and peripheral blood pressures, pulse wave velocity, arterial stiffness, maximal voluntary~     contractions of the medial gastrocnemius and Stroop tasks.. Two experimental sessions will~     take place involving extended sedentary time (one involving uninterrupted sedentary time and~     one including ten heel raises every ten minutes). A control condition of 15 participants will~     then be tested ten weeks post-. The experimental condition of 15 participants will undergo a~     ten-week heel raise prescribed programme before having peripheral and central blood pressure,~     pulse wave velocity, arterial stiffness, peripheral and cerebral oxygen perfusion, cognitive~     performance and maximal voluntary contraction of the medial gastrocnemius assessed after~     their programme.~   "
10957|NCT03423420|"~     Recent studies indicated the central venous pressure (CVP) as a prognostic marker. Therefore,~     we retrospectively analyzed the CVP on admission to the intensive care unit (ICU) in cardiac~     surgery patients regarding its prognostic value for morbidity and mortality.~   "
10958|NCT03423407|"~     The purpose of this research proposal is to establish a mechanism to develop tools that will~     allow the investigators to measure the impact of magnetic resonance (MR) acquisition~     correction sequences for attenuation correction on positron emission tomography (PET)~     quantitation accuracy.~   "
10959|NCT03423394|"~     Untreated posttraumatic stress disorder (PTSD) is associated with high societal and~     individual costs. Effective interventions for symptoms of posttraumatic stress (PTS) exist~     but are underutilized by those who could benefit, especially among active duty military. This~     study will develop and test a brief telephone-delivered motivational enhancement intervention~     (MET) for active duty Army and Air Force personnel who are experiencing symptoms of PTS, but~     who are not currently engaged in PTS treatment. The goal of the intervention is to decrease~     stigma around seeking care, increase knowledge about treatment options, increase engagement~     in help-seeking behavior, all leading to reductions in PTS symptoms.~   "
10960|NCT03423381|"~     The aim of the project is to study the connection between bacterial fermentation in the colon~     of prebiotic substrates and effects on systemic metabolism and appetite i healthy humans~   "
10961|NCT03423368|"~     This is a randomized, double blind, placebo controlled, interventional clinical study aimed~     at evaluating the effects of the medical device Libramed (Policaptil Gel Retard®) on the~     glycemic, lipid and weight profile in overweight and mild obese subjects~   "
10962|NCT03423355|"~     Dapagliflozin effect on erythropoiesis and physical fitness in patients with type 2 diabetes~     - a randomized, double-blind, controlled, parallel group, exploratory study~   "
10963|NCT03423342|"~     Mitochondrial dysfunction has been implicated in heart failure (HF), and is associated with~     an imbalance in intracellular ratio of reduced nicotinamide-adenine dinucleotide (NADH) to~     oxidized nicotinamide-adenine dinucleotide (NAD), or the NADH/NAD ratio. In mouse models of~     HF, we have found that normalization of the NADH/NAD, through supplementation with NAD+~     precursors, is associated with improvement in cardiac function. This Study will randomize~     participants with systolic HF (ejection fraction ≤40%) to treatment with the NAD precursor,~     nicotinamide riboside (NR) or matching placebo, uptitrated to a final oral dose of 1000mg~     twice daily, to determine the safety and tolerability of NR in participants with systolic HF.~   "
10964|NCT03423329|"~     This Randomized study was designed to assess and compare the effect of two analgesic~     premedications (Ibuprofen BP 100 mg/5 ml and Paracetamol 200 mg/5ml.) on the anesthetic~     efficacy of buccal infiltration in vital pulpotomy of primary mandibular molars in children .~     A multivitamin with the same color as the twp tested medications will be administered to~     children in the control group. Parents of eligible children will be informed about the nature~     of the procedure, the purpose of the study, any possible discomfort or risks and a signed~     informed consent will be obtained from them prior to enrollment.~   "
10965|NCT03423316|"~     In this project, the investigators propose to use high-resolution magnetic resonance imaging~     (MRI) to measure blood perfusion in different groups of calf muscle. This imaging approach is~     standard of care for evaluation of coronary artery disease (CAD), and has never been~     successfully applied to PAD. Preliminary results show distinct patterns of muscle perfusion~     between healthy and PAD patients, and thus great promise of the technique. The investigators~     will first verify the reproducibility of the technique, and then compare the calf muscle~     perfusion measures in PAD patients against healthy age-matched controls. This comparison will~     test the feasibility of detecting functional abnormality in PAD patients. After the baseline~     scans, the PAD patients will opt to undergo a 12-week supervised exercise therapy, and then a~     post-therapy MRI scan. Comparison of the pre- and post-therapy measurements will indicate how~     the therapy improves the calf-muscle perfusion, and how this perfusion change correlates with~     increases in patient's walking ability.~      The long term goals of this project are to develop an improved diagnostic test for patients~     with PAD to predict who will benefit from therapeutic intervention. The MRI perfusion studies~     of calf muscle can be performed in conjunction with routine peripheral MR angiography to~     assess the functional significance of vascular stenosis.~   "
10966|NCT03423303|"~     A population-based randomised trial of prostate cancer screening will be carried out. A total~     of approximately 67,000 men aged 50-63 in Helsinki and Tampere are randomised to intervention~     (screening) or control arm. A reduction in harms of screening in the form of overdiagnosis is~     sought, while retaining as much as possible of the mortality benefit (reduction in prostate~     cancer mortality). Novel methods that have been shown to increase specificity for clinically~     relevant prostate cancer but never tested in a randomised setting will be employed in~     screening and diagnostics. The main end-point is prostate cancer mortality at 10 and 15 years~     of follow-up.~   "
10967|NCT03423290|"~     A prospective, multicenter, observational evaluation of the safety and efficacy of the FRED®~     device in the treatment of intracranial aneurysms~   "
10970|NCT03423238|"~     Although coronary heart disease (CHD) treatment guidelines recognize obesity as a major~     modifiable risk factor,2 nearly half of all CHD patients are obese and the current standard~     of care fails to implement evidence-based obesity treatment for this high-risk population.~     Multiple lines of evidence suggest that weight loss improves outcomes in CHD patients. The~     primary goal of this study is to determine the feasibility of adding a 6-month behavioral~     weight loss intervention to exercise-based cardiac rehabilitation.~   "
10971|NCT03423225|"~     This study's objective is to evaluate the incidence rate of acute rejection reactions after~     24 weeks treatment with ADVAGRAF® following 3 months treatment with tacrolimus in new liver~     transplant recipients.~      Treatment conversion will take place from twice daily tacrolimus to once daily tacrolimus~     (ADVAGRAF) 3 months after transplant in new liver transplant recipients.~   "
10972|NCT03423212|"~     Just Do You is a young-adult-centered and theoretically guided intervention that has shown~     promise for keeping young adults connected to their professional treatments, while also~     enhancing their hope for the future and their own recovery. Just Do You is a brief two-module~     engagement program that utilizes a hybrid provider team of a licensed clinician and peer to~     address mistrust, lack of hope for the future, stigma concerns, literacy and a sense of~     efficacy early on when young adults begin a new service experience in adult outpatient day~     programs (i.e., New York State Personalized Recovery Oriented Services). The aim of this~     study is to test Just Do You through a moderately-sized randomized trial in order to see if~     it improves initial and secondary engagement among young adults with serious mental health~     conditions. The program is designed as an orientation to services, coupled with a curriculum~     designed to enhance motivation and agency, and keep young adults connected to their care.~      This study utilizes a randomized controlled trial to test the preliminary impact of the~     intervention, compared to best available services (treatment as usual, TAU) at two outpatient~     programs for adults with serious mental illnesses (n = 195). The program was adapted to~     two-sessions from the piloted four-session version through conversations with leadership at~     partnering agencies. The intervention involves intensive staff training and 24 months of~     ongoing provision, monitoring and supervision of the program. Quantitative survey data will~     be collected at baseline (pre), 2 weeks (post), 1 month, and 3 months. In this~     intention-to-treat analysis, we will conduct basic omnibus analyses to examine whether Just~     Do You leads to improved outcomes relative to TAU utilizing t tests across treatment~     conditions for each outcome measure specified. The investigators will likewise examine~     whether changes in the proposed mediating variables differ across groups.~   "
10973|NCT03423199|"~     This study is conducted to evaluate the benefit of adding palbociclib in hormone receptor~     (HR)-positive, HER2-negative advanced or metastatic breast cancer patients, regardless of~     menopausal status, treated with tamoxifen (with or without goserelin) versus tamoxifen alone~     (with or without goserelin).~   "
10974|NCT03423186|"~     MPS IIIA, also known as Sanfilippo A, is an inherited lysosomal storage disease (LSD). MPS~     IIIA is caused by a deficiency in sulfamidase, one of the enzymes involved in the lysosomal~     degradation of the glycosaminoglycan (GAG) heparan sulfate (HS). The natural course of MPS~     IIIA is characterized by devastating neurodegeneration with initially mild somatic~     involvement. The aims of the present study is to assess the dose related safety,~     tolerability, PK and PD of SOBI003, a chemically modified recombinant human (rh) Sulfamidase~     developed as an enzyme replacement therapy (ERT).~   "
10975|NCT03423173|"~     The purpose of this study is to investigate lot-to-lot consistency in terms of equivalence of~     the immune responses induced by 3 consecutive TDV lots in healthy participants aged 18 to 60~     years in non-endemic country(ies) for dengue.~   "
10976|NCT03423160|"~     There is long-standing recognition that people with autism spectrum disorders (ASD) have~     difficulty imitating others' actions; some investigators have highlighted impaired imitation~     as being a core contributor to the development of autism. What is yet unknown is precisely~     how imitation in children with ASD differs from that of typically developing peers.The~     investigators have identified a task parameter that separates preserved from impaired gesture~     imitation in ASD: children with ASD have difficulty imitating when the task requires two~     separate movement elements be coordinated simultaneously. By contrast, imitation is~     relatively preserved when movement elements are performed serially. The coordination of~     simultaneous movements is a hallmark of actions performed in the real world. With an eye to~     optimizing common therapies that depend heavily on imitation, the next step is to tease apart~     where, in the chain from perception to action, the capacity limitation in simultaneous~     processing lies. This study will be conducted in about two days and will involve imitating~     gestures that are presented via video. In addition, an EEG will record the brain's electrical~     activity during certain tasks to assess how the brain responds when the imitation task is~     more or less difficult. Several other clinical and behavioral measures will also be used.~   "
10977|NCT03423147|"~     Surgical site infections (SSI) are the second most common cause of nosocomial infections~     accounting for 15% of all nosocomial infections among hospitalized patients and 38% of~     nosocomial infections in surgical patients. In obstetric patients, infectious morbidity (i.e.~     SSI, endometritis) occurs in 5-10% of cesarean sections, which is 5-fold higher than vaginal~     deliveries. Additionally, infectious morbidity is thought to be highest in those patients who~     have cesarean sections after undergoing labor.~      Chlorhexidine, a chemical antiseptic effective on gram positive and gram negative bacteria,~     reduces skin microflora/colonization but it is not clear if it decreases the risk of SSI.~      Historically, chlorhexidine has been studied and used in orthopedic and cardiac implant~     surgeries. Research on the use of chlorhexidine for SSI prevention in cesarean sections is~     limited. This study intends to evaluate the effectiveness of use of both chlorhexidine~     gluconate (CHG) wipe and vaginal scrub in reducing SSI in patients undergoing cesarean~     section that have previously been laboring. Patients will be randomized to one of two groups:~     wash with both a pre-operative CHG cloth prior to surgery and chlorhexidine gluconate vaginal~     scrub in addition to standard preoperative scrub as compared to standard preoperative scrub~     alone.~   "
10978|NCT03423134|"~     This study investigates the performance of a new adhesive~   "
10979|NCT03423121|"~     This study aims to identify the safety and tolerability of bile acid supplementation in~     patients with progressive Multiple Sclerosis (MS). Participants will also be assessed for an~     impact of the bile acid on their immune system and gut microbiome. Half of the participants~     will receive the bile acid tauroursodeoxycholic acid (TUDCA) and half will receive placebo.~     The investigators believe participants who take TUDCA will have normalization of blood bile~     acid levels, a normalization of abnormal immune response and a normalization of the gut~     microbiome.~   "
11007|NCT03422757|"~     This is an exploratory study to preliminary assess safety and efficacy of an adaptive Deep~     Brain Stimulation (DBS) closed-loop method in patients with PD.~      The study has been designed as a double blind randomized crossover trial that uses~     conventional DBS as a concurrent control in PD patients in need of Implantable Pulse~     Generator (IPG) replacement.~   "
10980|NCT03423108|"~     One-center randomized, three-arm, parallel, superiority, controlled trial in 132 elderly~     outpatients with type 2 diabetes. Two different combined exercise training doses (300min/week~     vs 150min/week) will be compared against usual care. The entire study length will last 24~     weeks, and assessments will be conducted at baseline, previously to the group allocation, at~     12 weeks and at 24 weeks just after the treatments' end. The study's primary outcome is the~     glycated hemoglobin level at 24 weeks. Secondary outcomes of clinical relevance to type 2~     diabetes and elderlies will also be acquired.~   "
10981|NCT03423095|"~     This research study is a six-week treatment pilot study to compare the effects of different~     exercise types on measures of tongue strength and swallowing pressure in typically aging~     older adults. Typically-aging older adults represent a group at risk for dysphagia~     secondary to sarcopenia of striated musculature important to swallowing. Participants at all~     study sites will be randomly selected into one of four study exercise groups. At some study~     sites, the investigators will also determine cortical activation patterns differences during~     motor execution and motor imagery of tongue exercises between the groups using near-infrared~     spectroscopy. The results of this study will inform refinement/further development of the~     mental practice protocol to use with patients with dysphagia in future studies.~   "
10982|NCT03423082|"~     18F Fluciclovine is a recently FDA- approved radiopharmaceutical for prostate cancer~     biochemical recurrence, which is only minimally eliminated by the kidneys and therefore the~     image interpretation is not affected by nonspecific urine activity in the ureters and~     bladder, which is advantageous for pelvic imaging. Recent literature suggests that~     Fluciclovine PET has diagnostic potential for a variety of solid tumors, thus, allowing new~     opportunities for noninvasive probing of glutamine metabolism and clinical use in patient~     management. Current literature indicates that amino acid transporters including that of~     glutamine are upregulated in endometrial and cervical cancer so that Fluciclovine PET may~     have clinical potentials. The hypothesis is that Fluciclovine PET provides better imaging~     properties and greater diagnostic confidence and accuracy than FDG PET does in pelvic~     malignancies.~      Given the lack of current clinical data, a pilot study providing a direct comparison of~     Fluciclovine PET with FDG PET is warranted. The investigators seek to conduct a pilot study~     with 10 subjects to evaluate the clinical utility of Fluciclovine PET for staging of cervical~     cancer and endometrial cancer. This research will compare the diagnostic performance of the~     research Fluciclovine PET/MRI with the standard-of-care FDG PET/CT as an exploratory~     endpoint.~   "
10983|NCT03423069|"~     A reduced content of FODMAPs (fermentable oligosaccharides, disaccharides, monosaccharides,~     and polyols) in the diet may be beneficial for patients with IBS diarrheal variant, but so~     far few randomized trials have reported data in favor of the effective therapeutic~     superiority of a low-FODMAPs diet compared to specific IBS dietary advice. On this basis, the~     present study is aimed, in a multidisciplinary perspective, at investigating possible changes~     in the symptom profile and intestinal permeability, GI peptides concentrations, metabolic and~     lipidomic profiles induced by these different diets in patients with IBS diarrheal variant.~   "
10984|NCT03423056|"~     Patients with gastrointestinal cancer often experience physical deconditioning; this could~     lead to an increased risk of complications, especially when they require major abdominal~     surgical procedures.~      It has been suggested that physical training in the preoperative period could improve their~     condition, reducing the risk of complications. Although this topic has been investigated, it~     has not been established yet the best short preoperative aerobic exercise program to enhance~     the aerobic capacity in patients with gastrointestinal cancer who are going to be to surgical~     primary management, and consequently, to help patients dealing with the physiological stress~     involved in a surgical intervention.~      Main objective:~      To determine the efficacy and safety of a 4 weeks preoperative exercise program in patients~     with gastrointestinal cancer scheduled for primary surgery.~      Materials and methods:~      This is a Phase II single arm clinical trial that will include patients between 45 and 70~     years, with confirmed gastrointestinal cancer (gastric, hepatic, colon or rectal cancer),~     without electrocardiographic abnormalities, and scheduled for primary surgery in 4 weeks or~     more since recruitment~      All the enrolled patients will receive a basal aerobic capacity assessment with the 6-minute~     walk test. Then, two physical therapist will prescribe them a supervised and individualized~     aerobic training program in 3 sessions per week during 4 weeks. Each session will last 50~     minutes and will increase the heart rate target weekly (from 50% to 70% of the maximum heart~     rate). The aerobic exercise will be carried on a treadmill or in a stationary bicycle.~      The post intervention aerobic capacity will be measured at week 3 and 4 with the 6-minute~     walk test. The main efficacy outcome will be peak oxygen consumption (VO2 peak) and the~     safety outcomes will be exercise-related adverse events and the program adherence.~      This protocol was approved by the Instituto Nacional de Cancerología's Ethical Board~   "
10985|NCT03423043|"~     This study is a prospective, departmental funded study examining the outcomes of Low Dose CT~     scans compared to Conventional Dose CT scans in patients who present to Duke University with~     a Distal Radius Fracture.~   "
10986|NCT03423030|"~     This is a randomized, double-blind, placebo-controlled, single ascending dose study conducted~     at one study center in Switzerland.~      Four (4) panels (A, B, C and D) of 8 male subjects (6 active and 2 placebo) each undergoing 2~     investigation periods and receiving either single doses of PBTZ169 at increasing dose levels~     or a matching placebo.~      Subjects will participate in only one panel. Blocks of 4 subjects (3 under active treatment,~     1 under placebo) will be investigated in parallel. Panels A and B are interleaved.~      Safety will be assessed throughout the study; serial ECGs and serial blood samples will be~     collected for the safety and PK assessment of PBTZ169.~      Dose escalation will be allowed once the Trial Safety Board has determined that adequate~     safety and tolerability after panel B and panel C completion has been demonstrated to permit~     proceeding to the next panel.~   "
11008|NCT03422744|"~     There is an interest in characterazing asymptomatic peripheral lung lesions beacause they~     could be an early form of neoplasm.~      These lesions are invisible in the endoscopic exam, so the samples must be made with a~     guiding technique.~      The trans bronchial biopsy after tracking by radial echo-endoscopic miniprobes can be used to~     collect tissue sample.~      When no diagnosis is made with this technique, the attitude can be discussed between~     different option: follow up versus an other sampling technique (transthoracic ponction,~     surgery,...).~      In this study the investigators will study the interest of a sampling guided by fluoroscopy~     after a negative sampling guided by radial echo-endoscopic miniprobe.~      People presenting with a peripheral lung lesion, invisible with a classical endoscopy, will~     be included after they sign an informed consent. The bronchoscopy will be executed after a~     local anesthesia and if there are no visible endobronchial lesions, the radial EBUS~     mini-probe will be used.~      If these samples give an anatomopathologic diagnosis consistent with the clinical context, no~     other exam will be proposed.~      If there isn't a diagnosis after this first exam, a second exam will be proposed to the~     participants including an histologic smear, a trans bronchial biopsy and a fine needle~     aspiration under fluoroscopic guidance.~   "
10987|NCT03423017|"~     Introduction Pierre Robin Sequence, PRS, incidence is about one hundred births per year in~     France. The main neonatal clinical manifestations are secondary to airway obstruction and~     food difficulties related to swallowing disorders. Despite recent progress, the pathogenesis~     of PRS is not fully understood.~      The hypothesis is that brainstem dysfunction, BSD, plays a central role in the pathogenesis~     of PRS.~      The purpose of the study is to achieve a complete evaluation of BSD to specify its role in~     the pathogenesis of PRS.~      The primary objective is to compare central apnea index (CAI) of infants with PRS with those~     of infants with isolated airway obstruction (AWO) and those of healthy infants in order to~     clarify the direct role of BSD.~      Material and Methods This prospective interventional study will be carried out in Lyon at the~     Hôpital Femme-Mère-Enfant and in Paris at the Hôpital Necker-Enfants Malades for 2 years. 3~     groups of patients will be studied: PRS, 50 patients, AWO, 50 patients and healthy, 30~     patients, included before 2 months of life. Infants will be followed for a maximum of 10~     months. The evaluations will be carried out for 48 hours between birth and 2 months of life~     and then for 24 hours between 6 and 10 months of life for PRS and AWO group. Concerning the~     healthy group, the evaluation will be carried out during 48h during a single hospitalization~     before 2 months. Polysomnography, holter-ECG, 24h gas exchange, impedance-pH monitoring and~     mental region EEG will be performed. The central apnea index (mean number per hour),~     obstructive apnea index, non-nutritive swallowing index (NNS), gastroesophageal reflux and~     NNS-respiration coordination will be assessed for each stage of sleep and compared between~     the three groups of patients.~   "
10988|NCT03423004|"~     The project topic consists on re-conciliating the fine tuners of the gene expression~     microRNAs and the immunopathogenic occasions responsible for skin disorders in context of~     skin infection and inflammation such as psoriasis. The skin is a network of effector cells~     and molecular mediators that constitute a highly sophisticated Skin Immune System (SIS)~     described by Jan D Bos in 1986. The cutaneous homeostasis maintenance is dependent on the~     cross talk between several immune sentinels present in the different compartments of the skin~     as well as the interplay between innate and adaptive immune responses. The whole is under the~     control of gene regulation. However, cutaneous homeostasis disruption occurs when the SIS~     safe framework erroneously sends aggravation signals due to gene regulation disbalance via~     inflammatory cellular and molecular mediators into the site of infection causing chronic~     inflammation characterized by thick red irritated skin lesions. The latter was showed to have~     a characteristic microRNA (regulators of gene expression) signature.~   "
10989|NCT03422991|"~     This is a prospective cohort study of patients with Heart Failure with an eighteen-month~     follow-up aimed to collect all demographic, clinical, biological and para-clinical data to~     study population characteristics, assess prognosis markers and occurrence of HF treatment~     side effects.~      Congestive Heart failure is a frequent pathology and its prevalence increases with age. Its~     prognosis stays pejorative despite years of major therapeutical progress. In recent trials,~     all-cause mortality rates at 1-year reach up to 20% and 50% at 5 years.~      Medical care of congestive heart failure is based on precise international recommendations.~     The association of Beta-Blockers, renin-angiotensin system blockers, mineralocorticoid~     receptor antagonists, represent the basis of the pharmacological treatment.~      Cardiac resynchronization treatment and implantable cardioverter-defibrillator are additional~     efficient treatments that reduce events in appropriately selected patients.~      Despite these improvements, the prognostic of congestive heart failure in registers is worse~     than those observed in randomized trials. This can be explained by differences in congestive~     heart failure patient populations and/or by a less rigorous medical care where treatments are~     not optimized.~      The evaluation of medical care in congestive heart failure is today of utmost importance.~      Integrating new pharmacological molecules, medical devices and the application of new~     recommendations have major interest for documentation and practical changes.~      The main objective of this cohort will be to evaluate the evolution of the 12-month quality~     of life score of a HF patient and the characteristics and treatments associated with it.~   "
10990|NCT03422978|"~     The investigators propose to determine the propofol and remifentanil sparing effects of a~     single dose of dexmedetomidine in the dental population. The investigators plan to do this by~     performing a blinded study with 4 test groups (3 experimental and 1 control), using BIS~     monitoring to titrate TIVA infusion to an acceptable depth of anesthesia.~   "
10991|NCT03422965|"~     This study is directed to evaluate the role of Optical Coherence Tomography Angiography~     (OCT-A) in the evaluation of the perifoveal vascular network in type 1 diabetic patients, and~     to investigate the relationship between OCT-A-derived parameters and demographic and clinical~     factors, as metabolic control and duration of the disease.~   "
10992|NCT03422952|"~     Stress reactions in emergency physicians will be measures using cortol-awakening-reaction,~     heart-rate-variability and standardised stress questionnaires~   "
10993|NCT03422939|"~     During the last update of the French FBDG, a survey with a representative sample of~     dieticians investigated 1) how to communicate portion sizes and 2) the most relevant time~     frame when delivering dietary guidelines. The objective was to determine how to express~     portion sizes and time frame for Food Based Dietary Guidelines (FBDG) using the feedback of~     dietitians. Data were obtained from an internet-based survey of 441 French dieticians~     (collected from November 24, 2013 through January 2, 2014).~   "
10994|NCT03422926|"~     The purpose of this study is to determine whether a messaging campaign affects the calories~     ordered for and consumed by children in a quick serve restaurant setting.~   "
11009|NCT03422731|"~     This pilot clinical trial studies multi-modality imaging and collection of biospecimen~     samples in understanding bone marrow changes in patients with acute myeloid leukemia~     undergoing total body irradiation (TBI) and chemotherapy. Using mutli-modality imaging and~     collecting biospecimen samples may help doctors know more about how TBI and chemotherapy can~     change the bone marrow.~   "
11010|NCT03422718|"~     This study evaluates a health theory based mobile health behavioral intervention to reduce~     blood pressure (BP) among hypertensive patients evaluated in a community Emergency Department~     (ED) setting.~   "
11208|NCT03420105|"~     The results of this study will contribute to a better understanding of prospective memory~     deficit processes in breast cancer in relation to sleep disorders frequently reported in this~     pathology. In the long term, a better understanding will make it possible to envisage~     appropriate treatments to compensate for these memory difficulties and to improve the~     autonomy of the patients.~   "
10995|NCT03422913|"~     Hepatectomy is the preferred method for the treatment of liver tumors. Since the liver is a~     double blood supply organ, massive hemorrhage during hepatectomy may lead to hemodynamic~     instability, prolonged portal vein occlusion and increased ischemia-reperfusion injury. In~     addition, bleeding during hepatectomy, intraoperative and postoperative blood transfusion are~     the main causes of postoperative morbidity and mortality. Therefore, bleeding control during~     liver resection is a critical technique. Based on the fact that liver is more tolerant to~     warm ischemia and hypoxia, a variety of techniques have been widely used for hepatic blood~     flow occlusion.~      With the prevalence of laparoscopy, more patients received laparoscopic resection of liver~     cancer. Bleeding has become a major constraint, so how to reduce the bleeding and preserve~     liver function has always been surgeons' concern.As conventional hepatic portal blood flow~     blocking technology is more mature, the risk of bleeding during laparoscopic liver resection~     mainly comes from hepatic veins in the process of hepatic parenchymal isolation. Although~     Ultrasound scalpel and Ligasure have been widely accepted in the treatment of laparoscopic~     hepatectomy, due to the thin hepatic vein and the high intraluminal pressure, it is also~     difficult to control the bleeding during surgery. How to prevent hepatic venous hemorrhage~     has become the key to reduce the bleeding . As sinusoidal pressure is affected by~     intrahepatic pressure, which is directly related to central venous pressure (CVP), reducing~     CVP can reduce the pressure in the hepatic veins and sinusoids hence reducing bleeding when~     the hepatic parenchyma is severed. That is the rationale of controlled low central venous~     pressure CLCVP) to reduce the risk of hepatectomy, which have been used maturely in open~     hepatectomy. Due to the low risk of hepatic and renal insufficiency and gas embolism in liver~     surgery, there is a potential risk of laparoscopic pneumoperitoneum and the risk of~     laparoscopic pneumoperitoneum is further increased. Therefore, how to implement CLCVP in~     laparoscopic surgery to reduce the risk of bleeding, also avoiding complications such as~     bleeding gas embolism, is a clinical problem to be solved, is rarely reported. A prospective~     randomized controlled trial (RCT) will be performed for laparoscopic hepatectomy in patients~     combine intraoperative combined hilar intermittent (Pringle method) with or without CLCVP to~     reduce the bleeding. This study was to investigate the safety and efficacy of CLCVP in~     combination with intermittent Pringle.~   "
10996|NCT03422900|"~     The purpose of this study is to evaluate the effect of a specific nutritional formula for~     diabetics on the development of hyperglycemia in patients with recent non-diabetic stroke who~     require admission and enteral nutritional support by nasogastric tube. As well as the effect~     on metabolic control, development of comorbidities, hospital stay, readmissions, mortality~     and tolerance of the formula under study.~   "
10997|NCT03422887|"~     The purpose of this study is to evaluate the postoperative pain and discomfort using~     flurbiprofen axetil or nalbuphine administration after oculoplastic surgery under general~     anesthesia.~   "
10998|NCT03422874|"~     This is an open label, dose escalation, phase I study of the combination of MLN9708 plus~     Nelfinavir.~   "
10999|NCT03422861|"~     This is a clinical trial of nabilone for patients with Inflammatory Bowel Disease (IBD) who~     are undergoing IBD-related surgery (Any abdominal surgery lasting for more than one hour).~     This study would include a total of 80 patients undergoing general surgery who will have~     Intravenous Patient Controlled Analgesia (IVPCA) after surgery. It is the intention to~     randomize these patients postoperatively into 2 groups of 40 patients:~        1. Patients who are chronic opioid users for chronic pain and have been exposed to cannabis~          or cannabinoid products, treated with IV PCA and nabilone as per protocol.~        2. Patients who are chronic opioid users for chronic pain and have been exposed to cannabis~          or cannabinoid products, treated with IV PCA and placebo as per protocol.~      The goal is two-fold. One is to demonstrate that patients will benefit from post-operative~     nabilone administration to achieve/maintain the opioid-sparing and pain modulation effects.~     Second is to demonstrate patients will benefit from the anti-inflammatory and~     immunomodulatory effects of nabilone to alleviate IBD symptoms and enhance recovery.~   "
11000|NCT03422848|"~     This study evaluates hydration (1.5 L of water daily during 1 year) in the lowering of blood~     glucose concentration in adults with signs of dehydration (elevated levels of the vasopressin~     marker copeptin and high urine osmolality). Half of participants will in addition to~     lifestyle advice receive extra water on top of their habitual fluid intake, and the other~     half (control) will receive only lifestyle advice.~   "
11001|NCT03422835|"~     To investigates the feasibility, practicability, safety and subjective as well as functional~     outcome of Robotic transanal total mesentery excision for rectal cancer in low site.~   "
11002|NCT03422822|"~     B7451015 is a Phase 3 study to evaluate PF-04965842 with or without Topical Medications in~     patients aged 12 years and older with a minimum body weight of 40 kg who have moderate to~     severe atopic dermatitis and have completed a qualifying Phase 3 study. The efficacy and~     safety of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily,~     will be evaluated over approximately two years of study participation. Patients who meet~     safety step-down criteria will have their dose reduced once, from 200 mg QD to 100 mg QD, or~     from 100 mg QD to placebo.~   "
11003|NCT03422809|"~     The overall goal of this study is to examine the influence of the menstrual cycle on~     micronutrient concentrations and plasma volume in healthy, reproductive-age women with~     regular cycles. The investigators aim to quantify changes in micronutrient biomarker~     concentrations (zinc, copper, iron, and vitamin A) and plasma volume across the menstrual~     cycle in healthy women.~   "
11004|NCT03422796|"~     To develop a pragmatic migraine model the investigators will induce headache in patients with~     migraine without aura with a phosphodiesterase inhibitor (cilostazol). If the headache~     responds to sumatriptan injection, the model can be used to test new drug candidates.~   "
11005|NCT03422783|"~     This study evaluates the correlation between NoL index response to standardized stimulus~     under general anesthesia and the post-operative pain, assessed by opioid consumption and~     numerical pain scores after video-assisted thoracoscopy (VATS).~   "
11006|NCT03422770|"~     This study is part of a research project in which new ultrasound-based techniques will be~     examined to improve clinical decision making for patients with aortic stenosis. These~     patients could develop increased amounts of myocardial fibrosis. This fibrosis is associated~     with the patients' prognosis. Fibrosis can be evaluated with magnetic resonance imaging~     (MRI), which unfortunately is quite expensive and not easily available. Ultrasound-based~     parameters will be developed for the assessment of the amounts of myocardial fibrosis,~     especially in the left ventricle. Then it will be examined whether these parameters can~     predict the patients magnitude of fibrosis and check for association with the patients~     prognosis. MRI will serve as a gold standard for quantification of myocardial fibrosis. The~     new echocardiographic techniques and parameters are expected to provide new insights in the~     interplay between aortic stenosis and left ventricular function, and to ultimately improve~     the care for patients with aortic stenosis.~      The present study's objectives are:~        -  Quantify the level of myocardial fibrosis in mild, moderate, and severe aortic stenosis~          compared with a healthy population.~        -  Evaluate the patients outcome after one and three year of follow-up~   "
11225|NCT03419871|"~     A longitudinal study to examine the relationships among sleep characteristics, stress, and~     child behavior problems in a community sample of toddlers (12-24 months- ages 12-15 months at~     enrollment) living in socioeconomically disadvantaged homes~   "
11011|NCT03422705|"~     Almost 40,000 people in the United Kingdom receive a new pacemaker annually. Because the~     pacemaker does not use the heart's normal conduction system, electrical activity from the~     pacemaker spreads more slowly, disturbing the timing of the heart's contraction, which can~     lead to heart muscle weakness and heart failure (HF).~      Those with the greatest requirement for a pacemaker and highest percentage of pacemaker beats~     are those at highest risk of heart muscle weakness.~      This pilot study will be in two stages. Patients will be approached after their pacemaker~     implant. Allocation to all treatment arms will be at random.~      At the normal 6w visit, all participants will undergo cardiac ultrasound, blood tests and~     complete a quality of life questionnaire. Participants will be allocated to optimal pacemaker~     programming (to limit pacemaker heartbeats) or standard care. Those allocated optimal~     programming will return 3m after the implant and those still needing a high proportion of~     pacemaker beats, will be asked to have a cardiac magnetic resonance (CMR) scan and will be~     randomly allocated to an angiotensin converting enzyme inhibitor (ACE inhibitor) a common~     treatment for blood pressure and HF or not. After another 6m all will undergo heart~     ultrasound, blood test and quality of life assessment, and where relevant, a second CMR scan.~   "
11012|NCT03422692|"~     The objective of this study is to investigate the use of human amnion chorion membrane~     (BioXclude®) as an exposed barrier in ridge preservation and whether the intentional exposure~     of this membrane to oral environment will adversely affect ridge healing, dimensions, and~     bone vitality. This is a randomized clinical study.~   "
11013|NCT03422679|"~     This is a phase I/II, non randomized, open-label, dose escalation study to investigate the~     safety, tolerability and preliminary efficacy of CB-103.~   "
11014|NCT03422666|"~     Some of the fat (triglyceride) from the food humans eat gets stored in the bowel. This~     triglyceride can then be released into the blood when another meal is consumed or in response~     to hormones. How the gut hormone glucagon-like peptide-2 (GLP-2) releases the triglyceride~     from the gut is not known. The research team in this study is interested in finding out how~     teduglutide (a degradation resistant form of GLP-2) releases stored triglyceride from the gut~     by evaluating how blood lipoproteins respond to teduglutide in healthy individuals.~   "
11015|NCT03422653|"~     This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the~     safety and efficacy of intravenous (IV) CR845 at a dose of 0.5 mcg/kg administered after each~     dialysis session. The study includes a 12-week Double-blind Phase and a 52-week Open-label~     Extension Phase.~   "
11016|NCT03422640|"~     This is open label single side study involvement 20 patient treated with Apremilast. Each~     enrolled patient may be evaluated at by a dermatologist using the Lichen Planopilaris~     Activity Index and Frontal Fibrosing Alopecia Index. Other measures include physician global~     assessment, dermatology quality of life and patients analogue score for pruritus. Pt will~     have visits at Week 0,2,4,8,12,16,20,24~   "
11017|NCT03422627|"~     Phase 1b To evaluate the safety and tolerability of multiple ascending doses of AMG 592 in~     subjects with steroid refractory cGVHD.~      Phase 2 To evaluate the efficacy of AMG 592 in subjects with steroid refractory cGVHD as~     measured by ORR at 16 weeks according to the 2014 cGVHD NIH Consensus Criteria.~   "
11018|NCT03422614|"~     The pathophysiology of primary immunodeficiencies (PID), which encompass a broad range of~     different diseases with susceptibility to infection and/or a deregulated inflammatory~     response, is poorly understood. Available treatments are often not specific for a distinct~     target and might be associated with side effects. To elucidate pathophysiology of different~     PIDs, stool, urine, blood, tissue biopsies and/or bone marrow will be collected and analysed~     for anti-microbial activity and inflammatory response. In a second step, targeted treatment~     for different PIDs might be developed preclinically and ex vivo according to underlying~     pathophysiology.~   "
11019|NCT03422601|"~     The primary objective is to validate that the Immunoscore® test (IS0 to IS4) is able to~     identify patients with high risk (IS 0-1) of relapse or death whichever occurs first among~     Stage III patients under oxaliplatin-based adjuvant therapy.~      Then the prognostic value of Immunoscore® Colon to predict disease free survival (DFS) will~     be assessed in Stage III patients under Oxaliplatin treatment in each arm of the IDEA trial~     (6- months and 3-months treatment).~      Finally, the additive value of the Immunoscore® test to stratify the DFS will be evaluated~     among standard clinical and biological parameters and tumor features.~   "
11020|NCT03422588|"~     The short-term advantages of minimally invasive colon resection have been well established in~     several randomized trials. A major factor in the development of morbidity is the surgical~     stress response with subsequent increased demand on the patient's reserves and immune~     competence. Although the advantage in term of stress response of laparoscopic surgery over~     open surgery has been widely reported, little is known about the role of Intracorporeal~     anastomosis.~      In an attempt to evaluate the surgical stress response after totally laparoscopic right~     colectomy a comparative study has been designed.~      Two surgical procedures will be evaluated:~        -  Totally laparoscopic right colectomy with intracorporeal anastomosis (Experimental~          group)~        -  Laparoscopic assisted right colectomy with extracorporeal anastomosis (Control group).~   "
11021|NCT03422575|"~     The present study was a randomized, open-label, two-period, two-sequence, cross-over study,~     conducted to find out whether the etoricoxib 120 mg film-coated tablet produced by PT Dexa~     Medica (test drug) was bioequivalent to the reference drug (Arcoxia® Film-Coated Tablet 120~     mg, PT. Schering-Plough Indonesia Tbk), under fasting condition with a fourteen days wash-out~     period, involving 26 healthy adult male and female subjects.~   "
11022|NCT03422562|"~     The gut microbiome plays a significant role in balancing the inflammatory system in the~     immature gut. A breakdown in this balance with altered colonization of the microbiota in very~     low birth weight (VLBW) preterm infants is associated with increased feeding intolerance,~     necrotizing enterocolitis (NEC) and sepsis. Probiotics are proposed to normalize microbial~     populations and decrease intestinal disease in preterm infants. There is limited data linking~     clinical outcomes with the biology of probiotics. We aim to study the colonization of the GI~     tract with probiotic species contained in a specific probiotic blend - Florababy - in VLBW~     preterm infants.~      Stool microbiome will be analyzed at 4 time points in 2 groups (one given Florababy and the~     other no) of infants less than 1000 grams birth weight and < 29 weeks gestation. A comparison~     of stool microbiome analysis and the incidence of feeding intolerance and time to reach full~     feeds in the two groups will be made.~   "
11023|NCT03422549|"~     Preterm babies have immature lungs and frequent pauses in their breathing which often~     necessitates breathing support. Nasal Continuous Positive Airway Pressure (CPAP) is one of~     the most commonly used tools but does not always provide enough support. A new option is~     non-invasive high frequency ventilation (NHFOV), which gently shakes the lungs to help with~     gas exchange and may decrease a baby's work of breathing. The investigators plan to study~     very low birth weight preterm babies who are generally well but require some support with~     their breathing. By inserting a special feeding tube with sensors into the stomach, the~     investigators can measure the electrical activity of the diaphragm (EAdi), which is an~     important muscle for breathing. By analyzing EAdi in babies receiving either CPAP or NHFOV,~     the investigators will be able to measure and compare how each method of support affects a~     baby's breathing. This important study will help us determine the most appropriate breathing~     support for preterm babies.~   "
11024|NCT03422536|"~     This randomized phase II trial studies how well ficlatuzumab with or without cetuximab work~     in treating patients with head and neck squamous cell carcinoma that has come back or spread~     to other places in the body and resistant to cetuximab treatment. Monoclonal antibodies, such~     as ficlatuzumab and cetuximab, may block growth signals that lets a tumor cell survive and~     reproduce, and helps the immune system recognize and fight head and neck squamous cell~     carcinoma.~   "
11025|NCT03422523|"~     This study evaluates the addition of Atezolizumab to current therapy of Rituximab,~     Gemcitabine and Oxaliplatin (R-GemOx) for patients with relapsed or refractory Diffuse Large~     B-Cell Lymphoma (DLBCL) that are not candidates for high-dose therapy. All patients will~     receive one cycle of R-GemOx. Three quarters of patients (Arm B) will go on to have a further~     5 cycles (every 14 days) of R-GemOx with Atezolizumab, with one quarter of patients (Arm A)~     continuing with 5 cycles of R-GemOx.~      The patients in Arm B will continue to have Atezolizumab every 21 days for 8 cycles whilst~     Arm A patients will enter an observational phase during this time.~      Follow up will begin at 12 months from initial treatment until month 32.~   "
11026|NCT03422510|"~     This is a multicenter, open label, randomized study investigating two dose titration regimens~     of CXA-10 in subjects 18 to 70 years of age with primary FSGS.~      The study will be performed at approximately 20 study centers across the United States of~     America (USA). The recruitment period is anticipated to be up to approximately 12 months.~     Approximately 30 subjects will be randomized to ensure 26 subjects complete the study.~   "
11027|NCT03422497|"~     The investigators will use multilevel multivariable regression analysis to measure the~     association of sex with provision of guideline-based perioperative care for hip fracture~     surgery in Ontario.~   "
11028|NCT03422484|"~     Transfers between interfaces of care are recognized as a source of medication discrepancies,~     medication errors (MEs) and potentially adverse drug events. ME are very common at hospital~     and may have important clinical and economic consequences. The lack and loss of medication~     information and communication between health professionals at points of care transition may~     often lead to ME. According to the literature, up to two thirds of medication histories~     contain at least one error. Some studies have compared pharmaceutical team with physician or~     nurse on the detection of UMD or ME and have reported that pharmacists were one of the best~     health care providers to establish medication history. To improve medication safety and~     decrease MEs rate, several institutions have recommended to develop medication reconciliation~     at all transition points such as admission, transfer and discharge. Medication reconciliation~     is the process that compares a patient's medication order to all medications that the patient~     has been taking and should take at admission, transfer and discharge of hospitalization.~     Medication reconciliation programs led by pharmacists are effective to reduce medications~     discrepancies. However, studies evaluating the efficacy of medication reconciliation program~     are very heterogeneous in terms of populations, definitions and methodology. Thus, proportion~     of ME differs enormously between studies, ranging from under 10% to over 60% at admission of~     hospitalization. Elderly patients with their numerous comorbidities associated with~     polypharmacy, such as patients of internal medecin unit, are at high risk of ME and at risk~     of safety issues. However, medication reconciliation process is very time consuming with an~     average of 30 minutes by patient. Thereby, review of all inpatients within 24 hours of~     admissions is very difficult or impossible. Targeting high-risk situation and high-risk~     patient are crucial to detect ME before causing harm. Therefore, evaluating the risk of MEs~     and their potential consequences in specific population of internal medicine unit using a~     validated medication reconciliation process seems of utmost importance for internal medicine~     specialist clinical practice and the decrease of ME rate. Consequently, the aim of our study~     was to (i) evaluate the prevalence of ME in an internal medicine unit at admission of~     hospitalization, (ii) determine the type of medication involved and the potential clinical~     impact of ME and (iii) identify factors associated with a risk of ME and serious ME.~   "
11029|NCT03422471|"~     We will study the effect of hypoglycemia (low blood sugar) on baroreflex sensitivity in~     participants with well controlled type 2 diabetes.~   "
11030|NCT03422458|"~     It is well known that following the loss of a single tooth, severe hard- and soft-tissue~     alterations may take place within the affected site, resulting in a subsequent reduction of~     both vertical and horizontal ridge dimensions, often not allowing neither appropiate pontic~     fabrication nor correct placement of endosseous implants.~      Over the past 20 years, various surgical procedures, grouped under the term of alveolar~     ridge preservation (ARP), have been introduced, aiming to maintain the existing soft and~     hard tissue envelope as well as a stable ridge volume, simplifying subsequent treatment~     procedures and optimizing functional and esthetic outcomes. They have been widely tested in~     controlled and not controlled clinical studies with various materials and approaches, and a~     number of recently published systematic reviews on this topic have confirmed the efficacy of~     ARP in preventing post-extraction dimensional changes of alveolar ridges.~      After these procedures a minimum of four to six months must be awaited before implant~     insertion can be performed, bringing the patient compromised comfort, function and aesthetics~     and needing of a second surgical procedure for the implant placement.~      Dental implant insertion at the time of tooth extraction (type I or immediate placement)~     reduced the number of dental appointments, of surgeries required and the overall treatment~     time. Nevertheless this surgical protocol does not provide predictable outcomes, since it may~     contribute towards a more pronounced bone resorption during healing. Different anatomical~     factors, as the thickness of the buccal bone wall and the dimension of the horizontal gap,~     may influence the dimensional changes of the alveolar crest following immediate implant~     placement. Such morphological changes could lead to negative esthetic complications, such as~     marginal soft tissues recessions, especially when affecting the buccal side of maxillary~     sites in patients with a high smile line.~      It is unknown if immediate implant placement plus grafting materials and/or barrier membranes~     could influence post-extraction dimensional changes of alveolar ridges. No consensus exists~     on the need for bone augmentation simultaneously with immediate implant placement.~     Furthermore, no human study has yet compared dimensional changes of both hard and soft~     tissues after two different treatments: an alveolar ridge preservation technique for a~     subsequent implant placement, and an alveolar ridge preservation technique with an immediate~     implant placement.~   "
11031|NCT03422445|"~     30 patients with advanced melanoma will receive apatinib plus Temozolomide as maintenance~     therapy.~   "
11040|NCT03422315|"~     Propofol is a widely used sedative anesthetic, but there are large individual differences,~     which making different patients with different sensitivity to propofol. The aim of this study~     was to analyze the effects of age, height, body weight, Drinking, metabolic enzymes CYP2B6~     and UGT1A9 on Pharmacological effects and pharmacokinetics of propofol, and to provide a~     reasonable reference for clinical anesthesia patients and evidence for individual dosage~     regimens.~   "
11226|NCT03419858|"~     The purpose of this psychophysical and pharmacologic study is to determine if slow-breathing~     induced pain relief is mediated by endogenous opioids in response to intravenous (IV)~     administration of the opioid antagonist naloxone during noxious heat stimulation. We were~     also interested in disentangling the endogenous analgesic mechanisms supporting~     mindfulness-based analgesia.~   "
11032|NCT03422432|"~     The study investigators hypothesize that prophylactic HIPEC is feasible and well tolerated in~     patients with colorectal cancers with high-risk of developing peritoneal recurrence.~      The aim of the pilot study is to test the feasibility of performing prophylactic HIPEC for~     colorectal cancer patients at high-risk of developing peritoneal recurrence in our~     institution, and determine the morbidity associated with such a procedure.~      Patients with high-risk of developing peritoneal recurrence are defined as patients with~        1. tumours involving the serosa and adjacent viscera (i.e. T4 cancers)~        2. krukenburg tumours (i.e. ovarian metastases)~        3. perforated tumours~        4. positive peritoneal fluid cytology~        5. minimal synchronous PC (nodules <1cm in the omentum and/or close to the primary tumour).~      The study investigators plan to assess feasibility according to~        1. The number of patients completing the treatment~        2. Time to adjuvant systemic chemotherapy, to evaluate if there is delay to adjuvant~          treatment~      Morbidity will be measured according to the Clavien-Dindo Classification, and graded~     according to low versus high grade morbidity.~      If prophylactic HIPEC is shown to be feasible, with acceptable morbidity, the investigators~     aim to carry out a randomized controlled trial to determine the effectiveness of prophylactic~     HIPEC in preventing the development of peritoneal metastases in patients with colorectal~     cancer at high risk of peritoneal recurrence.~   "
11033|NCT03422419|"~     The PROGRESS is an investigator-initiated, multicentre, randomized, trial comparing~     anticoagulation, which is the currently most frequently used treatment, alone, versus~     transjugular intrahepatic portosystemic shunt (TIPS) combined with anticoagulation, in~     patients presenting with ROPVT. The rationale of this study is to significantly increase the~     proportion of patients that achieve a complete or partial recanalization of the portal vein.~     The intervention of this study consists in TIPS deployment and catheter based clot removal in~     addition to anticoagulation. The investigators retain that this intervention will increase~     the proportion of patients with an open portal vein from 38% with anticoagulation alone to~     83% with anticoagulation and TIPS after 6 months. Both anticoagulant therapy and clot~     removal/TIPS are treatments that are currently available and accepted indications for the~     treatment of ROPVT. Anticoagulation will be performed with unfractioned heparin or low~     molecular weight heparin initially and with vitamin K antagonists in the long term. The~     investigators plan to collect blood for biobanking at the time of inclusion and after 6~     months. Blood samples for a biobank will be collected.~   "
11034|NCT03422406|"~     To explore main cause and health impact of iodine excess during pregnancy, we performed~     iodine evaluation for 390 consecutive pregnant women from January 1st, 2016 to December 31st,~     2016. Among them, 18 women (4.62%) with apparently elevated urinary iodine concentration~     (UIC) were enrolled onto this study for subsequent follow-up. History of high iodine exposure~     was collected from all participants. Parameters about iodine status were monitors until~     termination of pregnancy, and dietary iodine intake condition and thyroid function were also~     evaluated.~   "
11035|NCT03422393|"~     The purpose of the study is to investigate whether the combination of venetoclax and~     ibrutinib (administered up to 840 mg per day) might be useful for the treatment of CLL or SLL~     that is not responding or no longer responding to treatment with ibrutinib alone. The study~     will evaluate whether this regimen can reduce the amount of cancerous cells in your body. If~     you agree, you will receive ibrutinib at a dose of up to 840 mg a day by mouth, as well as~     venetoclax. Although both of these agents are approved by the FDA for the treatment of CLL or~     SLL, the combination and the dosing schedule of ibrutinib are considered experimental.~   "
11036|NCT03422380|"~     Obesity is reaching epidemic proportions and threatens both health and quality of life of~     people around the world. While many individuals succeed at short term weight loss, weight~     loss maintenance is the greatest barrier to successful treatment of obesity. High levels of~     physical activity are consistently associated with success in weight loss maintenance. The~     major goal of this proposal is to understand how and why high levels of physical activity are~     critical for long term maintenance of weight loss. This project takes advantage of the~     National Weight Control Registry (NWCR), which follows over 6000 individuals who have~     maintained a weight loss of ≥30 pounds for ≥1 year. Understanding how individuals successful~     at weight loss maintenance achieve energy balance will provide important insight into~     strategies to help more people sustain a weight loss.~   "
11037|NCT03422367|"~     The investigators are running an intervention study for young children with Tuberous~     Sclerosis Complex (TSC). The study will include free play-based behavioral intervention that~     may improve social and communication skills in children with TSC. Eligible families will have~     a child in the age range of 12-36 months, with a diagnosis of TSC. A parent must also be~     available to attend intervention and assessment sessions at the research site (UCLA or BCH).~      The intervention will focus on teaching caregivers skills to improve the social and~     communication outcomes of their children. The content of the intervention will be~     individually tailored to the child's developmental level. The intervention involves 4 on-site~     assessment visits, and 12 weekly intervention sessions. The intervention focuses on improving~     social-communication and play skills.~   "
11038|NCT03422354|"~     The paravertebral block (PVB) is a block of the mixed nerve soon after it exits the~     intervertebral foramen.(2) It provides intense unilateral analgesia of long duration and has~     become the primary anesthetic for many applications.(3) Paravertebral Block (PVB) involves~     injection of local anaesthetic in a space immediately lateral to where the spinal nerves~     emerge from the intervertebral foramina. This technique is being used increasingly for not~     only intra-operative and post-operative analgesia but also as a sole anaesthetic technique~     for carrying out various procedures. This popularity is mainly due to the ease of the~     technique and fewer complications.(4) The increasing demand for hip arthroplasties over the~     last decades has sparked the creation of new and innovative anesthetic techniques and~     analgesic pathways with the goal to support best possible outcomes among this frequently~     elderly patient population. As a result, today different perioperative treatment pathways are~     available to physicians and their patients. In this context, the focus has shifted to~     techniques based on regional anesthetic and analgesic techniques. This trajectory has been~     fueled by a number of advantages including effective, long-lasting and focused pain control,~     decreased need for systemic analgesics and earlier mobilization.~   "
11039|NCT03422328|"~     The aim of the trial is to study the long-term safety of macitentan and to provide continued~     treatment with macitentan to patients with pulmonary arterial hypertension (PAH) who were~     previously treated with macitentan in clinical studies.~   "
11041|NCT03422302|"~     When receiving stereotactic body radiotherapy (SBRT), it is important that you do not move so~     the radiation therapy can be delivered to the tumor. For patients with tumors in their chest,~     it is very hard to keep the area still because breathing may cause the tumor to move.~      The goal of this clinical research study is to compare 2 different methods of lowering the~     amount of tumor movement in patients who are receiving SBRT. In this study, a breath-holding~     technique (the standard method) and a device called continuous positive airway pressure~     (CPAP) will be compared. The CPAP device blows air into your lungs while you wear a face mask~     or nozzle to help expand your airways and lungs.~      This is an investigational study. The CPAP device is FDA-approved and commercially available~     for expanding the airways. It is considered investigational to use it to lower the amount of~     tumor movement during SBRT therapy.~      Up to 30 participants will be enrolled in this study. All will take part at MD Anderson.~   "
11042|NCT03422289|"~     PCOS patients are initially treated with 2 g myo-inositol and 0.2 mg folic acid, two times~     per day by oral route, for three months. Among them, the subjects who have not ovulated~     despite this treatment are administered with 2g myo-inositol and 0.2 mg folic acid plus 50 mg~     α-lactalbumin for three months. Most of them improve and achieve ovulation. Therefore, the~     combination of α-lactalbumin with myo-inositol allows to get a significant result in the~     treatment of PCOS patients.~   "
11043|NCT03422276|"~     Each year, about 2.8 million people sustain a traumatic brain injury (TBI) in the United~     States, and at least 25 percent of these injuries are classified as moderate to severe.~     Nearly half of those hospitalized for TBI have long-term disability. Most have psychological,~     physical, social, or work-related problems, which often become chronic. By talking with~     patients and family members, we found that returning to daily activities and regaining~     quality of life are major concerns. Outcomes are affected by the type and severity of the~     TBI, but the type of treatment someone with TBI receives is also important. What resources~     are available, whether providers are experienced with the problems associated with TBI, and~     how much treatment is available can affect outcomes as well.~      Currently, inpatient rehabilitation professionals are told to give people with TBI~     information, reassurance, advice, and referral resources. Some promising ways of helping~     people with TBI include using telephone and other mobile devices to reach patients after they~     leave the hospital, to regularly assess their individual needs and help them coordinate their~     health care, and to provide the information and resources that they need. These new~     strategies may lead to earlier return to activities and improved quality of life. No studies~     have compared the standard approach to discharge care with an approach that uses telecare to~     provide information and care coordination after discharge from inpatient rehabilitation for~     TBI.~      The main goal of this project is to find out how improving the transition from the hospital~     to outpatient care can improve the lives of people with moderate to severe TBI and achieve~     better results that are important to patients with TBI, their families, and healthcare~     providers. In this study, patients with TBI who are discharged from inpatient rehabilitation~     at one of six national TBI Model Systems sites (University of Washington, Indiana University,~     Ohio State University, Mount Sinai Hospital, Moss Rehabilitation, and Baylor Institute for~     Rehabilitation) will be randomized (like the flip of a coin) to either the standard discharge~     plan or the standard discharge plan with additional telephone follow up for the first 6~     months after discharge. The project team will compare patient and caregiver functioning and~     quality of life at 3, 6, 9, and 12 months after hospital discharge in these two groups.~   "
11044|NCT03422263|"~     The PUSH Study is conceived to investigate the early effects of SGLT-2-Inhibitors on the~     physical performance of patients with Type-II-Diabetes mellitus compared to patients under~     other therapy regimes. Patients shall be divided into 3 groups: I - Patients with type II~     diabetes mellitus under new treatment with an SGLT2-Inhibitor. II - Patients with type II~     diabetes mellitus without SGLT-2- Inhibitor medication. III - Patients without type II~     diabetes mellitus but with similar comorbidities to the previous groups.~   "
11045|NCT03422250|"~     This pilot study aims to test clinical and connectivity changes following non-invasive~     stimulation of disease-specific networks in Alzheimer's disease (AD) and behavioral variant~     frontotemporal dementia (bvFTD). Brain network stimulation will be carried out with~     transcranial direct current stimulation (tDCS). Target networks will be the default mode~     network (DMN) and salience network (SN). Twenty AD and 20 bvFTD patients will be recruited~     and assessed with a comprehensive clinical, behavioral and cognitive battery, and 3T MRI scan~     (including resting-state fMRI, arterial spin labeling, diffusion tensor imaging, structural~     MRI) at three time-points: baseline, after tDCS, and after 6 months. Patients will be~     randomized to 2 arms: anodal stimulation of the disease-specific network (DMN in AD, SN in~     bvFTD) or cathodal stimulation of the anti-correlated network (SN in AD, DMN in bvFTD). The~     intervention will consist of 10 tDCS sessions over two weeks. CSF samples will be collected~     at baseline for biomarker's assessment; blood samples will be collected at each time-point to~     assess changes in peripheral inflammatory markers. Blood and CSF collection will be optional.~     A sample of 20 elderly controls will be included for baseline comparisons.~   "
11046|NCT03422237|"~     The purpose of this study is to evaluate the infectivity, safety, and immunogenicity of the~     recombinant live-attenuated respiratory syncytial virus (RSV) vaccines RSV ΔNS2/Δ1313/I1314L~     or RSV 276 or placebo when delivered as nose drops to RSV-seronegative infants and children 6~     to 24 months of age.~      This study is a companion study to IMPAACT 2018.~   "
11047|NCT03422224|"~     In this study, we will establish a workflow to generate unique patterns of the donor-reactive~     T cell repertoire using mixed lymphocyte reactions to select alloreactive T cell clones prior~     to transplantation Tissue infiltrating as well as blood bound T cells will be characterized~     based on:~        1. Identification of donor-specific T cell receptor sequences pre- and post-transplant by~          in vitro expansion to determine unique patterns~        2. Quantification and comparison of donor-specific T cell clones in kidney biopsy and blood~          samples.~        3. Analysis of the TCR repertoire diversities derived from kidney biopsy and blood samples~          and association of repertoire diversities with the histomorphological phenotype of T~          cell mediated rejection.~        4. Identification of T cell subtypes within the donor-reactive population. We specifically~          hypothesize that highly expanded donor-reactive T cell clones in both kidney tissue and~          blood samples at time of indication biopsy are associated with the histological~          phenotype of acute T cell mediated rejection. We have previously shown that there is a~          strong correlation between highly expanded tissue-resident T cell clones and the~          repertoire found in periphery blood samples. To trace and quantify donor reactive T~          cells we will apply a truly quantitative approach for immune repertoire profiling based~          on high- throughput sequencing. Our ultimate goal is to develop a diagnostic tool to~          assess alloreactive cellular immunoresponses based on peripheral blood samples.~   "
11092|NCT03421639|"~     With this study the investigators want to test which is the best medical treatment for~     symptomatic uterine fibroid, mostly abnormal uterine bleeding, between Ulipristal acetate~     versus Aromatase inhibitor plus GnRH analog, in term of uterine and fibroid volume reduction~   "
11048|NCT03422211|"~     There was a study titled A prospective evaluation of opioid utilization after upper~     extremity surgical procedures: Identifying consumption patterns and determining prescribing~     guidelines by Dr. Matzon and team from Thomas Jefferson University that came up with a~     simple set of opioid guidelines post-surgically. These guidelines are helping to guide~     surgeon's prescribing patterns and ideally limit the number of prescribed pain medicines. We~     plan to identify typical narcotic analgesic usage post sports orthopaedic surgery. We hope to~     identify the number of narcotic pain pills to prescribe to patients undergoing orthopaedic~     sports surgery in the future.~   "
11049|NCT03422198|"~     This randomized phase III trial studies short course vaginal cuff brachytherapy to see how~     well it works compared with standard of care vaginal cuff brachytherapy in treating patients~     with stage I-II endometrial cancer. Short course vaginal cuff brachytherapy, also known as~     internal radiation therapy, uses (over a shorter period) radioactive material placed directly~     into or near a tumor in the upper portion of the vagina to kill tumor cells.~   "
11050|NCT03422185|"~     Cross-sectional survey of all adults residing in two defined geographical regions in urban~     Lilongwe and rural Karonga District. Participants were interviewed, had anthropometric~     measures taken, and had fasting blood specimens taken.~   "
11051|NCT03422172|"~     The pre-exposure prophylaxis (PrEP) is an important component in the overall strategy for~     prevention of HIV infection. Cabotegravir (CAB) is an integrase strand transfer inhibitor~     currently in development for treatment and prevention of HIV infection. CAB possesses~     attributes that allow formulation and delivery as a LA parenteral product. CAB is being~     developed as both oral and long acting (LA) injectable formulations. This study is designed~     to evaluate the PK, safety, tolerability, and acceptability of CAB LA in adult HIV uninfected~     Chinese male subjects at low risk for HIV acquisition. Eligible subjects will receive oral~     CAB during oral phase of the study followed by CAB LA intramuscular (IM) injection during~     injection phase of the study. Approximately 60 subjects will be screened, of which,~     approximately 48 subjects will enter the oral phase and 40 subjects will enter the injection~     phase of the study. The maximum study duration will be approximately 89 weeks including oral~     phase, injection phase and follow-up phase.~   "
11052|NCT03422159|"~     This study has been created to compare the addition of intravenous (IV) vitamin C, thiamine,~     and hydrocortisone to the usual standard of care of sepsis and septic shock. Sepsis is a~     possibly life-threatening condition in which a patient may have organ dysfunction due to an~     infection. Septic shock is defined as low blood pressure and organ dysfunction that do not~     improve after administering IV fluids. Standard of care for sepsis and septic shock include~     early administration of IV antibiotics, IV fluids, and vasopressors if need be to provide~     oxygen to vital organs.~      A large amount of experimental data has shown that vitamin C and corticosteroids decrease the~     release of inflammatory substances which may lead to organ failure seen in sepsis. Vitamin C~     and corticosteroids also improve blood flow to vital organs and increase the body's ability~     to respond well to vasopressor medications used in septic shock. Low blood levels of both~     thiamine and vitamin C are common in sepsis. The study will be placebo controlled, meaning~     one group will receive vitamin C, thiamine, and hydrocortisone, and the other will receive an~     inactive substance (placebo). The goal of the study is to compare the effects of receiving~     vitamin C, thiamine, and hydrocortisone (along with the standard sepsis care) versus placebo~     and standard sepsis care.~   "
11053|NCT03422146|"~     Previous studies have shown the clinical and antimicrobial efficacy of eyelid hygiene with~     tea tree oil (TTO) in resolving chronic blepharitis. Cliradex® is a novel over-the-counter~     eyelid wipe which contains the most active ingredient of TTO. The present study is a~     single-centre, randomized, trial comparing Cliradex® eyelid hygiene and I-Lid 'n Lash®~     Hygiene, another over-the-counter eyelid wipe, without any medicinal ingredients, in treating~     chronic blepharitis. The Primary Outcome Measure will be the difference in change in the~     number of CFU's after 2 weeks treatment, between the groups. The Secondary Outcome Measure~     will be the difference in change in objective clinical signs and symptoms by performing a~     vision check, a questionnaire, and visual grading, of each participants' blepharitis after 2~     weeks treatment, between the groups. The Tertiary Outcome Measures will be the difference in~     change in microbial CFUs and clinical signs and symptoms between the groups at the 4 and 6~     week point, (2 and 4 weeks after discontinuing treatment), to evaluate if the treatment will~     produce a lasting effect.~      Participants will be randomized into one of the treatment arms. They will use the appropriate~     treatment for two weeks. They will then be re-assessed. They will discontinue treatment at~     this time, and four weeks later, will be assessed one last time, to see if the temporary~     treatment provides a lasting effect. A sub-group of ten patients per group will also be~     randomized to an extra visit. This group will be assessed after two weeks of having stopped~     the wipes. The same testing and procedures will be performed at this appointment.~   "
11054|NCT03422133|"~     Many people have inpatient surgery each day. Most people will have no complications but some~     will have minor or serious complications. The risk of having complications can vary from one~     person to another depending on personal factors such as; age, medical conditions such as~     diabetes and whether someone smokes or takes certain medications.~      The Investigators have learned that people want more information about their surgeries, both~     the general information about the risk for complications, but also more specific information~     about whether they are personally more or less likely to have complications. Patients are~     also interested in practical information such as how long they might stay in the hospital and~     what the recovery period will be like for them. Receiving more information can help decrease~     a person's level of anxiety about their surgery.~      The Investigators are doing this study with the assistance of the mHealth Lab at The Ottawa~     Hospital (a team that develops simple technologies for managing health information). The~     Investigators will implement and evaluate a novel, innovative tablet-based, patient-oriented~     risk communication application to evaluate patient knowledge of their own surgical risk~     before and after their visit to the Pre-Admission Unit (PAU). The Investigators will also be~     exploring any potential levels of anxiety before and after the PAU visit, in addition to~     patient satisfaction with their PAU visit.~      The Investigators hypothesize that it will: improve patient knowledge and experience, not~     increase anxiety, be acceptable to patients and clinicians, and will improve care efficiency~     for TOH surgical patients.~   "
11055|NCT03422120|"~     Natural killer (NK) cells are leukocytes of the innate immune system and play a central role~     in the control of cancer metastases. NK cells and other innate immune cells often do not~     function well in patients with cancer and are also profoundly suppressed after cancer~     surgery. Dr. Auer's Lab and others have shown that NK cells are critically important in the~     clearance of tumor metastases and that their impairment can be recovered with immune therapy~     augmenting the innate immune system. Several studies suggest that cancer patients have~     depressed NK cell cytotoxicity as compared to healthy controls but that following resection~     of the cancer, NK cell cytotoxicity returns to normal levels. In this observational study,~     the investigators will measure NK cell cytotoxicity by the gold standard method (51Cr, a~     chromium51 release assay) and by a new interferon-ɣ (IFN-ɣ) based assay (NK-Vue™) in healthy~     humans and colorectal cancer (CRC) surgery patients seen a The Ottawa Hospital. The results~     of this study will determine if the NK-Vue™ is able to discriminate between healthy human~     volunteers and newly diagnosed cancer patients and is sufficiently sensitive to detect~     transient NK cell suppression immediately following surgery.~   "
11056|NCT03422107|"~     PNI (Peripheral Nerve Injury) occurs in 5-15% of patients in cardiac surgery. So far, the~     mechanism of injury has never been researched. In this study, we will compare minimally~     invasive cardiac surgery with conventional cardiac surgery using a novel portable SSEP device~     to pinpoint the mechanism and timing of PNI during cardiac surgery.~   "
11057|NCT03422094|"~     This is a single institution, open-label, multi-arm, pilot study assessing the safety,~     feasibility, and immunogenicity of a personalized neoantigen-based vaccine plus poly-ICLC~     (NeoVax) combined with immune checkpoint inhibitors in subjects with newly diagnosed,~     unmethylated glioblastoma.~   "
11058|NCT03422081|"~     Principal objective : Validation of a handy biochemical parameter, plasma concentration of~     Asymmetric DimethylArginine (ADMA), based on a recognize biochemical parameter, the dilation~     of the brachial artery, at ultrasound examination, after the deflation of a cushion to~     evaluate artery dysfunction (vascular suffering) in growth diseases, growth hormone~     deficiency (GHD) and intrauterine growth retardation (IUGR)~      Secondary objectives:~        -  Comparison of ADMA plasma concentrations with dose of matched healthy control children~        -  Investigation of the mechanisms of arterial dysfunction, inflammation, oxidative stress~          and insulin resistance.~   "
11059|NCT03422068|"~     Part 1: Multiple Rising Dose (MRD) The primary objective is to investigate safety and~     tolerability of BI 1015550 in patients with IPF.~      The secondary objectives are to investigate the effect of BI 1015550 on the target engagement~     biomarker and to evaluate the pharmacokinetics (PK) of BI 1015550~      Part 2: On top of standard of care (SOC) The primary objective is to evaluate the safety and~     tolerability of the identified dose of BI 1015550 from Part 1 in patients with IPF on top of~     nintedanib and pirfenidone, respectively.~      The secondary objectives are to evaluate the pharmacokinetics of BI 1015550 when~     co-administered with nintedanib and pirfenidone.~   "
11060|NCT03422055|"~     The development of an innovative imaging agent capable of non-invasively detecting vulnerable~     plaques is a major objective of research in cardiovascular pathology. Such a tool would allow~     for better identification of patients at risk of acute events. We showed that 99mTechnetium~     (99mTc)-labeled fucoidan was able to target P-selectine expressed by activated platelets in~     vitro in humans and in vivo in a model of abdominal aortic aorta thrombus and endocarditic~     vegetations in rats.~      One of the objectives of the Nanoathero program is the clinical translation of the~     99mTc-fucoidan. As a first step, we will assess the safety, biodistribution and dosimetry of~     this new radiopharmaceutical in humans.~   "
11061|NCT03422042|"~     Common bile duct stone cholangitis is a potentially fatal condition, characterized by an~     obstruction and bacterial infection of biliary system. The principles of management are~     appropriate biliary drainage and systemic antibiotics. There has been limited data about~     appropriate time of antibiotics in patient with successful endoscopic drainage.~   "
11062|NCT03422029|"~     The purpose of the study is to evaluate efficacy and safety of Peptide Receptor Radionuclide~     Therapy (PRRT) with 177Lu-Dotatate in patients with inoperable, progressive, somatostatin~     receptor-positive (SSTR+), neuroendocrine tumours of GEP-NEN~   "
11063|NCT03422016|"~     This study aims to find out the incidence of a reduced light adapted electroretinogram (ERG)~     b-wave amplitude in children with a diagnosis of Autism Spectrum Disorders (ASD).~   "
11064|NCT03422003|"~     This study is a randomized trial of hypofractionation (short-course) radiation therapy versus~     conventional radiation therapy in women who have undergone mastectomy and immediate breast~     reconstruction. The investigators will assess cosmetic and reconstruction outcomes,~     lymphedema, cancer status, side effects, and oncologic outcomes.~   "
11065|NCT03421990|"~     -  To assess the changes in liver functions postoperatively in patients with preoperatively~          elevated liver enzymes.~        -  To identify the most appropriate anesthesia technique for patients with preoperatively~          elevated liver enzymes.~        -  To assess the effect of intraoperative event (bleeding, hypoxia, hypotension, prolonged~          operation) on liver functions in these patients.~   "
11066|NCT03421977|"~     This is a long term, safety follow up study of patients in the AVXS-101-CL-101 gene~     replacement therapy clinical trial for SMA Type 1 delivering AVXS 101. Patients will roll~     over from the parent study into this long-term study for continuous safety monitoring for up~     to 15 years.~   "
11067|NCT03421964|"~     The aims of this traumatic brain injury (TBI) study are:~        1. to evaluate the short and long-term efficacy of two structured outpatient intervention~          programs, Resilience and Adjustment Intervention (RAI) vs. RAI with follow up booster~          sessions (RAI+) on resilience~        2. to evaluate the short and long-term impact of intervention on emotional well-being and~          postinjury adjustment with the RAI vs. the RAI+~        3. to evaluate the short and long-term impact of the RAI and the RAI+ on abilities~          including problem solving, communication, and stress management~        4. to determine if demographic, lifestyle, injury, or treatment response information can~          predict maintenance of gains~   "
11068|NCT03421951|"~     Study Title Subject-reported treatment efficacy and procedure satisfaction (steps)~     study.BURST study- a prospective observational clinical study examining the changes in~     quality of life and pain following spinal cord stimulation for the treatment of chronic~     intractable lower back and lower limb pain.~   "
11069|NCT03421938|"~     This study is planned for investigating effect of downhill-uphill walking exercises on~     functional level and muscle strength in patients with knee arthroplasty. Patients who have~     had primary knee arthroplasty and has gone 3 months after surgery will be included in this~     study. The patients will be divided into two groups by randomization. Totally, 22 patients~     will be included in this study. Every patients will have same standart post-operative~     rehabilitation programme. In addition,group 1 will have downhill walking exercises with %10~     slope; group 2 uphill walking exercises on the treadmill with %10 slope. Assessments will be~     made before and after treatment.~   "
11070|NCT03421925|"~     Laparoscopic inguinal hernia repair techniques has been compared with the open techniques in~     several studies. However, no one studied about the different uses of the same type of mesh on~     the same surgical technique, and effects of this different use on testicular volume and blood~     flow. The objective of this study is to investigate the effects at 6 months of the divided~     and non divided mesh in laparoscopic totally extraperitoneal hernia repair technique on~     testicular volume and blood flow by use of Doppler Ultrasonography~   "
11071|NCT03421912|"~     This randomized comparative study aims to evaluate the satisfaction and quality of life of~     patients using Cicaplast balm B5, versus Dexeryl, for the management of cutaneous toxicities~     of iEGFR in squamous cell carcinoma of the head and neck, cancers colorectal or pulmonary~   "
11072|NCT03421899|"~     Parkinson's disease (PD) is a progressive neurological disorder that is increasingly common~     with age, with the incidence rising from approximately 4 people per 10,000 in their forties~     to 2 in 100 over the age of eighty.~      Our understanding of the causes of PD has rapidly developed in the past two decades, but this~     has not yet translated into any clinically established neuroprotective treatment that slows~     disease progression. There is a growing consensus that the failure of previous efforts is~     mainly due to the causative diversity of PD i.e. that PD may have many different causes. For~     example, it is known that variants in mitochondrial (cellular power house) genes can cause~     specific forms of PD and this may be relevant to other forms of PD.~      The aim of this study is to attempt to group PD patients based on markers of biochemical~     dysfunction (e.g. into groups of patients that do and those who do not have evidence of~     mitochondrial dysfunction) to aid in the development of new candidate neuro-protective~     compounds.~      The investigators hope by grouping people with Parkinson's into those with and without~     impaired mitochondrial function the investigators will be better able to develop more~     targeted treatments aimed at protecting further loss of brain cells that occurs in~     Parkinson's disease.~      To achieve this the investigators will study people, in two study sites in London, with both~     genetic forms of PD and those with idiopathic PD (i.e. those where there is not a known~     genetic variant causing PD), as well as a healthy control group. All groups will undergo~     standardised clinical assessment to collect information on several aspects of their condition~     (e.g. disease severity, memory problems and sleep problems).~      Participants will be asked to provide blood, urine and optionally cerebrospinal fluid & skin~     samples from which various biochemical assays and genetic analysis will be performed in~     attempt to group participants based on the results of these tests. The study is funded for 3~     years with participants being asked to attend for up to 3 study visits each over this time~     period.~   "
11073|NCT03421886|"~     The purpose of this study is to evaluate the efficacy of the Aerodentis System for~     orthodontic tooth movement in an open label, two-arms, non-inferiority clinical study. This~     open-label, two-arm study will follow 45 patients for up to fifteen months. Thirty~     participants will wear the Aerodentis device, and fifteen participants will wear Invisalign,~     a commonly used clear appliance. Patients will be assigned to participate in the treatment~     group using the Aerodentis device at home for 10 hours daily or in the control group using~     clear correctors for the duration of up to 15 months. Outcome assessments will be performed~     every 4 weeks. Assessments will include tooth movement and quality of life assessments.~   "
11074|NCT03421873|"~     Chest pain is a common presenting complaint at the Emergency Department (ED). Many of these~     patients undergo lengthy assessments in the ED or are admitted which contributes to ED and~     hospital crowding as well as a substantial health care burden. The now commonly used~     high-sensitivity cardiac troponin assays enable faster rule-out of acute myocardial~     infarction (AMI). The European Society of Cardiology (ESC) recommend the use of a 0h/1h~     high-sensitivity cardiac troponin T (hs-cTnT) protocol, but all studies so far have been~     observational. The safety and effectiveness of the protocol when implemented in routine care~     is thus unknown.~      The aim of this study is to determine the safety and effectiveness of the ESC 0h/1h hs-cTnT~     protocol, supplemented with clinical assessment and ECG, when implemented in routine care.~   "
11075|NCT03421860|"~     The purpose of the study is to evaluate the cardiac output changes after an intravenous bolus~     of ephedrine, phenylephrine, ondansetron or norepinephrine during a spinal anesthetic for a~     cesarean delivery.~      For elective cesarean delivery, all participants will receive spinal anesthesia with a local~     anesthetic and sufentanil. This study includes 120 pregnant women. Patients will be randomly~     assigned according to a computer generated system to be in one of four groups.~   "
11076|NCT03421847|"~     This study evaluates the vestibular activity in major depression patients and healthy~     controls using the rotatory test and electronystagmography.~   "
11077|NCT03421834|"~     The aim of this study is to assess whether preventive substrate ablation of chronic total~     occlusion infarct-related artery (CTO-IRA) area in heart failure (HF) patients correlates~     with lower appropriate implantable cardiac defibrillator (ICD) therapies. In addition, the~     purpose of the study is to determine whether prophylactic substrate ablation at the time of~     primary ICD implantation in high-risk ischemic patients affects unplanned hospitalization, HF~     progression, and quality of life.~   "
11078|NCT03421821|"~     Quadratus lumborum block can be used for the hip surgery and abdominal surgery postoperative~     analgesia. But the lower thoracic to the hip dermatome can't be blocked at the same time. The~     anesthetists used the same method, but had produced the different dermatome were blocked. The~     investigators hypothesized that this was due to local anesthetics was injected to different~     locations of the anterior thoracolumbar fascia. If the investigators inject local anesthetics~     to the anterior layer of thoracolumbar extrafascial, this produced the dermatomal coverage~     from lower abdominal to hip. A different situation was when the investigators injected local~     anesthetics to anterior thoracolumbar subfascia, the lower thoracic dermatome were blocked.~   "
11093|NCT03421626|"~     The objective of this study is to establish the performance of an assay that detects mRNA~     transcript levels in patients diagnosed with CML. The study is conducted at locations within~     the United States. Testing is performed on peripheral blood specimens provided by eligible~     enrolled patients. Results from this study will not be used for patient management decisions.~   "
11094|NCT03421613|"~     Post-herpetic neuralgia (PHN) is pain following acute herpes zoster; defined as pain lasting~     longer than 3 months. Current first line management consists of tricyclic anti-depressants~     and anti-convulsants such as gabapentin and pregabalin. There is an unmet medical need for~     treatments got topical therapies that demonstrate efficacy without serious side effects.~   "
11079|NCT03421808|"~     Daily prefrontal TMS for depression, as developed by the PI, involves delivering TMS pulses~     to the prefrontal cortex and not assessing what the actual EEG phase is of the person's~     brain. In cardiology, in order to stimulate the heart effectively, one has to know the rhythm~     and phase of the heartbeat in order to perform cardioversion. The investigators wonder if it~     is important to time the brain stimulation with the phase of the person's brain. The brain~     has definite rhythms, and cycles through being excited or resting. A common EEG rhythm is~     alpha frequency. Theoretically, the effect of the TMS pulse might be diminished if it was~     delivered when the brain was temporarily cycling into an off state.~      In the r21 part of this grant, the investigators designed and constructed a combined~     TMS/EEG/fMRI system. With that equipment the investigators found that TMS pulses have~     different effects deeper in the brain as a function of the EEG alpha phase. Pulses delivered~     during a rising phase produce larger blood flow changes deeper in the brain than do pulses~     delivered during a falling phase.~      In the R33 phase of the grant the investigators now take that idea into a small clinical~     trial in depression to test if synchronized pulses have a larger clinical effect than do~     non-synchronized pulses.~   "
11080|NCT03421795|"~     This study investigates the impact of pain training delivery for respite care providers who~     support children with developmental disabilities on (a) pain assessment and~     management-related knowledge, (b) participant self-rated perceptions of the feasibility,~     confidence and skill in pain assessment and management, and (c) strategy use. Half of the~     participants will receive the pain training, while half will receive the training about~     family-centered care, and be offered the pain training after completion of the follow-up.~   "
11081|NCT03421782|"~     This randomized pilot phase II trial studies how well exercise intervention with or without~     internet-based cognitive behavior therapy works in reducing fatigue in patients with stage~     III-IV breast cancer or prostate cancer that has spread to other places in the body and~     usually cannot be cured or controlled with treatment. Exercise intervention and~     internet-based cognitive behavior therapy may help to improve feelings of tiredness in~     patients with breast or prostate cancer.~   "
11082|NCT03421769|"~     The purpose of this study is to explore whether corneal epithelial autograft (EA) combined~     with allogeneic middle lamellar keratoplasty (AMLK) is more effective than limbal autograft~     (LA) with AMLK for ocular surface reconstruction in patients with severe ocular burns.~   "
11083|NCT03421756|"~     This is a prospective pilot study of matched-related donor allogeneic stem cell~     transplantation in adults with severe sickle cell disease using a matched-sibling PBSC graft~     with a non-myeloablative conditioning regimen (Alemtuzumab).~   "
11084|NCT03421743|"~     The trial is an open-label, non-controlled, multicenter, pilot clinical trial of inhaled~     molgramostim (recombinant human Granulocyte-Macrophage Colony Stimulating Factor; rhGM-CSF)~     in subjects with persistent pulmonary Nontuberculous Mycobacterial (NTM) infection. Subject~     will be treated for 24-weeks with inhaled molgramostim and will be followed up for 12-weeks~     after end of treatment. The primary aim of the trial is to investigate the efficacy of~     inhaled molgramostim on NTM sputum culture conversion to negative.~   "
11085|NCT03421730|"~     The primary objective of this study is to evaluate budesonide levels in the blood following~     inhalation of single doses of VR647 Inhalation Suspension in children with wheezing, reactive~     airway disease or mild asthma using a nebulizer, the VR647 Inhalation System. Secondary~     objectives include the evaluation of the safety and tolerability of VR647 Inhalation~     Suspension administered using the VR647 Inhalation System.~   "
11086|NCT03421717|"~     Peri-implantitis is defined as inflammation in the mucosa surrounding an oral implant with~     loss of supporting bone. The goals of peri-implantitis treatment are to resolve inflammation~     and to arrest the progression of disease. It is important to systematically gather~     information on the effect of surgical peri-implant treatment and to assess different~     protocols regarding chair-side maintenance of peri-implant tissue after surgery~      The aims of this clinical investigation are to evaluate the clinical, microbiological and~     radiographic outcomes of surgical treatment of peri-implantitis and to evaluate the efficacy~     of 2 supportive treatment protocols based on the use of titanium cyrettes or by the use of a~     flexible, biodegradable chitosan brush. Furthermore, to evaluate the impact of this therapy~     on selected biochemical markers associated with chronic inflammation and bone tissue~     destruction.~   "
11087|NCT03421704|"~     This multi-center observational study will prospectively collect data from patients who have~     an indication for servo ventilation therapy. This registry is intended to characterize the~     patient populations that may benefit from DreamStation BiPAP autoSV therapy (PR DS-autoSV,~     Philips Respironics, Monroeville, PA) in real life settings. In addition, this registry will~     assess adherence to the PR DS-autoSV therapy, the therapeutic benefits, collect morbidity and~     mortality data of servo ventilation in patients with central sleep apnea (CSA) and complex~     sleep-disordered breathing (SDB).~   "
11088|NCT03421691|"~     The purpose of this investigation is to evaluate the safety and efficacy of the Cutera excel~     V Laser Genesis procedure utilizing the 1064nm Nd:YAG laser for skin rejuvenation.~   "
11089|NCT03421678|"~     The study will investigate the role of 1,3-butadiene metabolic activation and deactivation in~     lung cancer risk among various ethnic/racial groups. This project will require urine samples~     from smokers and nonsmokers from the three ethnic/racial groups recruited by the Clinical and~     Biomarker Core for the analysis of 1,3-butadiene DNA adducts. Data on nicotine intake~     (urinary TNE) in these subjects as well as in 400 lung cancer cases and 400 controls from~     Project 1 will be also required for this project.~   "
11090|NCT03421665|"~     Evaluate clinical healing and radiographic maintenance of correction following an LCL~     procedure or medial cuneiform osteotomy (Cotton) at 6 months following the use of the TITAN~     3-D™ Wedge. Subjects who receive one or more TITAN 3-D™ Wedges will obtain satisfactory~     levels of clinical healing and radiographic maintenance of correction at 6 months.~   "
11091|NCT03421652|"~     This phase II trial studies how well nivolumab works with radiation therapy in treating~     patients with urothelial bladder cancer that has spread from its original site of growth to~     nearby tissues or lymph nodes and are ineligible for chemotherapy. Monoclonal antibodies,~     such as nivolumab, may interfere with the ability of tumor cells to grow and spread.~     Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving~     nivolumab and radiation therapy may work better in treating patients with urothelial bladder~     cancer.~   "
11095|NCT03421600|"~     The adenoma detection rate by colonoscopy for asymptomatic individuals aged 50 years and~     older is estimated to be at least 25%. It is known that during colonoscopy, lesions may be~     missed. Image enhanced endoscopy techniques have been evaluated for the detection and~     differentiation of colonic polyps. Narrow band imaging (NBI), is one such technique. The~     common classification systems used predict histology is the NICE and the Sano and JNET~     classification. The NICE classification can be used without optical magnification; it~     evaluates the color of the lesion, regularity of the overlying vessels and regularity of the~     surface pattern. The Sano and JNET classification requires optical magnification in order to~     assess the capillary patterns such as whether there is dilation, irregularity or loss of~     irregular capillaries over the lesion. In the context of adenoma detection, the results are~     more contentious. A meta-analysis of randomized studies examining the utility of the first~     generation NBI system when compared to high definition WLI showed no difference in detection~     rates. A criticism of the NBI system had been the dark endoscopic view; this is a result of~     the optical filter, and can limit the far view. A second generation NBI system has since been~     developed. It is characterized by much brighter illumination despite the optical filter, and~     thus the far view is improved. A recent randomized controlled study compared the~     second-generation NBI system with high definition WLI. NBI was shown to improve polyp and~     adenoma detection rates compared to WLI. Blue laser imaging (BLI) is another form of narrow~     bandwidth imaging developed by Fujifilm Corporation (Tokyo, Japan). Instead of using an~     optical filter for white light to produce narrow bandwidths, the BLI system has a unique~     feature of illumination using two lasers and a white light phosphor to accomplish the visual~     enhancement of surface vessels and structures. This study aims to determine whether BLI can~     increase the detection rate of colonic polyps and adenomas when compared to white light~     endoscopy, with the null hypothesis being no difference in detection rates. This study will~     also examine the use of NICE and Sano/ JNET classification systems to predict histology with~     the BLI system.~   "
11096|NCT03421587|"~     Post-traumatic stress disorder (PTSD) is associated with altered processing of sensory~     stimuli. The clinical phenotype of PTSD has predominantly been described for the visual and~     auditory sensory modalities. However, PTSD symptoms such as intrusive memories are often~     evoked by olfactory and tactile cues in the environment. The purpose of this study is to~     compare trauma-exposed subjects who developed PTSD and trauma-exposed subjects who did not~     develop PTSD with non-exposed controls in the processing of olfactory and tactile stimuli.~     This sensory characterizations hold potential to identify potential biomarkers for the course~     of PTSD and to inform trauma therapies focusing on sensory integration.~   "
11097|NCT03421574|"~     The proposed study is to evaluate the safety and initial efficacy of MRgFUS for patients with~     treatment-refractory MDD. This study is designed as a prospective, single arm, nonrandomized~     study. Assessments will be made before and after MRgFUS for adverse events related to~     treatment, for clinical symptom relief, and quality of life (QoL). The target in the brain~     chosen for ablation will be the anterior limb of the internal capsule (i.e 'capsulotomy').~   "
11098|NCT03421561|"~     The ILLUMENATE Pivotal PAS is a continued follow-up study which will include 300 subjects~     from forty-three (43) sites across the United States and Austria previously enrolled in the~     ILLUMENATE Pivotal pre-market study to evaluate the Stellarex DCB compared to the PTA control~     device for the treatment of de-novo or post-PTA occluded/stenotic or reoccluded/restenotic~     (except for in-stent) SFA and/or popliteal arteries.~   "
11099|NCT03421548|"~     The purpose of this study is to evaluate the safety and performance of the EYEMATE system in~     patients undergoing concomitant implantation of a BKPro type 1 and an EYEMATE sensor over the~     24 months period beginning at implantation.~   "
11100|NCT03421535|"~     The purpose of this study is to investigate if stretching the contralateral sacroiliac (SI)~     joint improves GIRD in baseball players. Additionally, we aimed to compare our SI joint~     stretching regiment with a classically described sleeper stretch routine.~   "
11101|NCT03421522|"~     Sacrifice of the intercostobrachial nerve (ICBN) during surgery is associated with~     development of persistent post-surgical pain (PPSP), which affects up to 60% of breast cancer~     surgery patients. A large, definitive trial is needed to establish whether nerve preservation~     techniques are effective in reducing post-surgical pain after breast cancer surgery. If the~     effect of ICBN preservation is consistent with observational studies, the absolute reduction~     of rates of persistent pain would be considerable.The primary objective is to determine the~     effect of ICBN preservation, versus usual care, on the prevalence and intensity of PPSP at~     one year after breast cancer surgery involving axillary lymph node dissection (ALND).~   "
11102|NCT03421509|"~     The cutaneous silent period (CSP) is a brief transient suppression of the voluntary muscle~     contraction that follows a noxious cutaneous nerve stimulation. Studies in patients with~     central disorders of motor control such as dystonia and Parkinson's disease have shown CSP~     abnormalities indicating that supraspinal pathways influence this inhibitory spinal reflex.~     The aim of this study is to investigate the association between CSP parameters (duration and~     latency) and spasticity in stroke.~   "
11103|NCT03421496|"~     The primary objective of this study is to evaluate the efficacy of Cannabidiol Oral Solution~     as adjunctive therapy with vigabatrin as initial therapy in treating participants with~     Infantile Spasms. The secondary objectives for this study are to evaluate the continued~     efficacy of Cannabidiol Oral Solution after the 14-day treatment with vigabatrin or~     vigabatrin plus Cannabidiol Oral Solution is complete and to evaluate the safety and~     tolerability of Cannabidiol Oral Solution as adjunctive therapy with vigabatrin as initial~     therapy in treating participants with infantile spasms.~   "
11104|NCT03421483|"~     Folate, a B-vitamin, is necessary in metabolic processes such as amino acid and nucleotide~     synthesis. Since folate cannot be synthesized by mammals, it must be consumed as foods and~     dietary supplements or generated by bacteria present in the colon. There are many known~     adverse health outcomes associated with folate deficiency in humans such as neural tube~     defects in newborns and colorectal cancer in adults. It has also been proposed that~     supra-physiological folate status can also be detrimental since it can lead to changes in~     immune function and the masking of vitamin B12 deficiency. It is generally believed that~     dietary sources of folate are primarily absorbed in the small intestine, however recent~     evidence suggests the colon may play a more significant role in the absorption of folate than~     previously understood. The aim of this study is to assess how folic acid supplementation~     influences colonic folate absorption and metabolism in humans. This will be accomplished by~     assessing the expression of two major folate transporters responsible for folate absorption~     in the colon. Participants will be randomized to receive multivitamins with either 0 or 400~     µg folic acid during a 16-week randomized clinical trial in which blood and colonic tissue~     biopsies will be collected and analyzed. The total folate concentrations and expression of~     folate transporters in colonocytes will be measured to confirm levels and evaluate the impact~     of supplemental folic acid. The expression of two folate hydrolases responsible for~     converting naturally occurring folate to its bioavailable form will also be evaluated. This~     work will lead to a deeper understanding of colonic folate absorption and metabolism,~     resulting in more appropriate dietary and supplemental folate recommendations.~   "
11105|NCT03421457|"~     This study is aimed to compare the efficiency of two uterus-preserving laparoscopic methods~     to treat uterine prolapse in a randomized controlled trial. Laparoscopic lateral suspension~     with mesh (LLSM) will be compared with laparoscopic sacrohysteropexy (LS). Both procedures~     are known as sufficient uterus preserving methods. LLSM was introduced to be an alternative~     to others with avoiding dissection of promontory and therefore being safer, faster and~     feasible technique.~   "
11106|NCT03421444|"~     Base on enriched resources from the Metabolic Syndrome cohort in children, a long-term~     prospective cohort study will be carried out. This cohort is a unique biochemical and genetic~     database of Chinese population with large number of subjects in the world. By collecting~     information of disease history and lifestyle, measuring clinical and metabolic parameters,~     especially biomarkers which can reflect the underlying mechanism of insulin resistance and~     metabolic syndrome, we intend to sort out some unique biochemical and genetic markers for~     Chinese population.~   "
11107|NCT03421431|"~     A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of~     EDP-305 in subjects with Non-Alcoholic Steatohepatitis~   "
11108|NCT03421418|"~     A prospective, randomized, controlled study designed to assess whether digital virtual~     reality (VR) models, created from existing CT scans and MRIs, provide surgeons with an~     improved understanding of their patients' anatomy, resulting in more efficient operations~     (robotic partial nephrectomy) and improved patient care.~   "
11109|NCT03421405|"~     EEG signals have been collected and studied since the early 1990's as a way of assessing~     brain function at a gross level. As early as the 1930's a derivative of the raw EEG signal -~     event-related potentials (ERPs) - have been computed. These scalp-recorded ERPs are the~     brains response to a stimulus of interest (e.g. a flashing checkerboard or an angry face).~     The timing and topographical location of ERP components lends insight into the timing and~     complexity of various cognitive processes. At NeuroCatch Inc., research is primarily focused~     on three ERP components: the N100, P300 and N400.~      To elicit the ERP components of interest in this study (N100, P300, N400), proprietary~     auditory stimulus sequences will be administered using the investigational device, the~     NeuroCatch Platform™. Each sequence consists of pure tones and word pairs to elicit the~     various components associated with different attention abilities (sensory processing, target~     detection & semantic processing). A secondary objective of the study will be to validate the~     auditory stimulus sequences tested.~      Understanding the degree to which these neurophysiological components fluctuate over time is~     crucial to our understanding of typical brain functioning. Research and medicine is moving~     away from behavioural responses to assess brain health (e.g. verbal responses, reaction time,~     etc.) and are moving toward more neuroimaging focused measures, such as CT, and MRI scans.~     The strength of utilizing EEG technology is two-fold: i) it is portable and ii) has high~     temporal resolution. Looking forward, EEG-based brain assessment technology could be~     implemented field-side, at the site of an accident for a quick assessment of brain and~     cognitive functioning, or within a clinicians' office to evaluate treatment efficacy.~     However, for this type of technology to be useful in quantifying brain health, we must first~     quantify the degree to which a healthy brain naturally fluctuates in it processing~     capability. For example, should technology such as the NeuroCatch Platform™ be used as a~     monitoring tool, we must have an idea of what normal variation is.~   "
11110|NCT03421392|"~     Idiopathic thrombocytopenic purpura (ITP) is the most frequent auto-immune cytopenia. There~     is no specific biological marker and the diagnosis often results from the exclusion of other~     differential diagnoses, notably inherited thrombocytopenia.~      Recent studies have reported an original platelet destruction mechanism in ITP, by~     antibody-mediated desialylation of membrane proteins. The detection of platelet sialylation~     can be readily achieved using flow cytometry. This could provide a new biomarker of ITP,~     useful to ascertain a diagnosis of ITP and guide towards proper patient management.~   "
11111|NCT03421379|"~     The purpose of this study is to determine the efficacy and safety of nasal glucagon compared~     to intramuscular (IM) glucagon for treatment of insulin-induced hypoglycemia in Japanese~     participants with diabetes mellitus.~   "
11112|NCT03421366|"~     A prospective single center observational cohort of patients with cystic fibrosis to~     determine whether adequate serum levels of posaconazole, after administration of the newer~     modified release once daily oral formulation, can be achieved.~   "
11113|NCT03421353|"~     This is a phase Ib/II, open-label multicentre study to assess the safety, tolerability,~     pharmacokinetics and preliminary anti-tumour activity of AZD9150 plus durvalumab alone or in~     combination with chemotherapy in patients with advanced, solid tumours and subsequently in~     patients with non-small-cell lung cancer (NSCLC).~   "
11114|NCT03421340|"~     To prospectively compare non-complex biliary stone clearance using fluoroscopy/radiation-free~     direct solitary cholangioscopy (DSC) utilizing the SpyGlass™ system with non-complex biliary~     stone clearance using standard endoscopic retrograde cholangiography (ERC).~   "
11115|NCT03421327|"~     This study is being conducted to learn more about family communication of genetic risk~     information. Semi-structured interviews lasting up to one hour will be conducted with three~     populations: parent/child pairs at risk for Huntington's Disease, parent/child pairs at risk~     for hereditary cancer, and genetic counselors.~   "
11116|NCT03421314|"~     The aim of this study is to evaluate the effect of zinc gluconate and/or selenium yeast~     supplementation during six months on clinical (glucose, cholesterol, triglycerides, bone~     mineral density and body composition) and immunological (oxidative stress, CD4+ count and~     pro-inflammatory cytokines) parameters in a population with HIV diagnosis on antiretroviral~     treatment.~   "
11117|NCT03421301|"~     Aim: To study the effect of a dietary intervention with functional foods on gut microbiota in~     subjects with type 2 diabetes Materials and methods: Patients with type 2 diabetes were~     enrolled in a double-blind, parallel-arm, placebo-control study were randomized to receive a~     dietary portfolio (DP) or placebo (P) treatment for 3 mo. The primary endpoint was the effect~     of a dietary portfolio based on functional foods on gut microbiota. Secondary endpoints were~     biochemical parameters, branched chain amino acids, TMAO~   "
11118|NCT03421288|"~     This is a multicenter, randomized, controlled, open-label study comparing perioperative~     atezolizumab with FLOT chemotherapy versus FLOT alone in patients with locally advanced,~     operable adenocarcinoma of the stomach or GEJ.~   "
11119|NCT03421275|"~     Intranasal esketamine, fentanyl and placebo are compared in treatment of acute pain in adult~     patients with minor trauma. Study is blinded randomized placebo-controlled parallel design.~   "
11120|NCT03421262|"~     The aim of the study is to evaluate differences in pregnancy outcomes and medical costs~     depending on gestational diabetes diagnostic criteria used (one vs two-step approach).~   "
11253|NCT03419507|"~     In this prospective, randomized, cross-over study, investigators aimed to compare the first~     pass successes of inexperienced doctors with Macintosh laryngoscopy and endotracheal tube~     introducer on a manikin with continuous chest compression in the ambulance simulation in the~     pre-hospital process.~   "
11121|NCT03421249|"~     This study is a randomized controlled clinical trial using a blind evaluator. Fifty-one~     volunteers were selected from 50 years to 70 years, obeying the following criteria: diagnosis~     of knee OA grade II and III through the radiographic classification of Kellgreen and Lawrence~     1955, Body mass index (BMI) less than 40 kg / m², volunteers should have had knee pain for at~     least six months. All are from the Rehabilitation Sector of Santa Casa de Misericórdia de São~     Paulo (ISCMSP). The subjects were evaluated through a questionnaire developed by the authors~     of the study (Annex I), the Visual Analogue Scale (EVA) (Annex II), then applied to the Lower~     Extremity Functional Scale LEFS (Appendix III) and the Activities of daily living scale ADLs~     (Annex IV). In addition, the evaluation of muscular strength was through dynamometry using~     the Lafayete dynamometer model 01163, which was performed by a blind evaluator regarding the~     group that will belong to each candidate. The muscles tested were: quadriceps, ischiostibial~     and gluteus maximus. The randomization was through 60 brown envelopes divided into A, B, C~     and D, designating the randomness of the sample.~      In addition to the initial evaluation, an evaluation was performed at the end of the tenth~     session and after 3 months of treatment.~      The volunteers underwent a five-week treatment program, totaling 10 sessions, divided into~     four groups, group A - Intervention (INT) underwent knee and hip muscle strengthening~     exercises and electromagnetic field therapy with (Meditea - ARG) using the coplanar~     technique, group B - Exercises (EXE) carried out exercises to strengthen the hip and knee~     muscles in the C - Placebo group (PLA). hip and knee and electromagnetic field therapy with~     the Magnetron® coplanar technique, but with the device switched off and group D - Apparatus~     (APA) only use electromagnetic field therapy with the magnetron® coplanar technique. In the~     present study, there were no significant differences between groups regarding pain, function~     and muscle strength. However, group A obtained better results in the evaluated criteria,~     tending that the combination PEMF and exercises, is an indicated treatment for OA knee.~   "
11122|NCT03421236|"~     Bladder cancer is the fourth and eighth most common malignancy among men and women,~     respectively. About 75% of bladder cancers are diagnosed as non muscle-invasive and according~     to specific tumor-stage and grade characteristics, intravesical immunotherapy with Bacillus~     Calmette-Guérin (BCG) is used to prevent recurrence and/or progression. However, BCG~     immunotherapy is associated with significant adverse events and treatment failure may occur~     in 30-40% of cases, hence the necessity for alternative therapies. In an orthotopic MB49~     mouse bladder cancer model, another bacterial vaccine (Ty21a/Vivotif) turned out to be more~     effective than BCG for inducing tumor regression and mice survival upon intravesical~     instillation; and potentially safer because Ty21a bacteria did not infect/persist in any mice~     tissues nor in human bladder explants or cell lines, in contrast to BCG. Ty21a/Vivotif has~     been used in the last 30 years in millions of individuals as an oral typhoid vaccine with a~     high safety record. In this phase I trial we will be testing the safety of intravesical~     administration of Ty21a and its effect on bladder immunity in non-muscle invasive bladder~     cancer (NMIBC) patients, for whom recommendation of BCG therapy is not mandatory.~   "
11123|NCT03421223|"~     The DiSCover Project is a 1-year longitudinal case-control observational study. In this~     study, the investigators plan to collect different types of data including self-reported~     health outcomes and quality of life data, behavioral data from activity trackers and health~     and fitness apps, data from lab tests, genetic data, and environmental data. One of the goals~     of this study is to develop digital biomarkers for chronic pain severity, flare ups and~     quality of life.~   "
11124|NCT03421210|"~     The goal of this study is to evaluate correlations between brain reactivity (as assessed via~     functional magnetic resonance imaging (fMRI) following 24-h abstinence) and the amount of~     smoking in a specific location. The investigators will use ecological momentary assessment~     (EMA) to ask smokers to rate their exposure to, and smoking in, specific personal smoking~     environment cues (PSEs) over the course of 2 weeks before quitting smoking and 2 weeks after~     quitting smoking. The investigators propose to identify 48 regular cigarette smokers who will~     complete 8 visits (1 screening visit, 1 training visit, 1 camera turn-in visit, 1 fMRI~     session and 4 post-quit medication check sessions). Multiple methods will be used to test~     hypotheses about brain functioning during cue-reactivity (CR). The investigators will examine~     correlation between brain responses to smoking environments (minus non-smoking environments)~     and smoking cessation outcomes (i.e. days to lapse, days to relapse). Our EMA+Global~     Positioning System (GPS) analysis will primarily focus on locations where smokers smoke~     before and after quitting smoking. The investigators will evaluate whether EMA-assessed~     smoking intensity values are correlated with brain responses to these personal smoking~     environments.~   "
11125|NCT03421197|"~     This is a randomized, double-blind, placebo-controlled, multicenter study designed to assess~     the safety and efficacy of PPC-06 (tepilamide fumarate) extended release in subjects with~     moderate-to-severe plaque psoriasis.~   "
11126|NCT03421184|"~     The study aims at determining if dietary phytoestrogens can be risk factors for Systemic~     Lupus Erythematosus (SLE). Dietary enquiry and phytoestrogens measurements will be performed~     in blood and urine of patients with SLE in an active phase of the disease, in patient with~     other autoimmune diseases and in healthy volunteers. Subjects will be premenopausal women and~     when possible at a define stage of the menstrual cycle. Free blood estradiol will be assayed~     as a confounding risk factor.~   "
11127|NCT03421171|"~     This study will describe which ethical dilemmas are experienced by anesthesiologist in the~     Dutch Healthcare system and what the current solving strategies are for these issues. Semi-~     structured interviews will be conducted with anaesthesiologists employed in different~     hospitals in the Netherlands..~   "
11128|NCT03421158|"~     The purpose of this study is to compare the analgesic effects of four non-pharmacological~     interventions: skin-to-skin contact, breastfeeding, oral sucrose and nonnutritive sucking in~     newborns receiving a heel lance procedure.~   "
11129|NCT03421132|"~     The investigators will track 250 multiple myeloma patients across Canada over time, using new~     lab tests to evaluate their blood and bone marrow, as they receive standard of care~     treatment. The main hypothesis is that these tests will allow clinicians to better diagnose~     and manage multiple myeloma, improving patients' quality of life overall.~   "
11154|NCT03420807|"~     This research project concerns the evaluation of the Metabolic Hyperspectral Retinal Camera~     (MHRC), a novel medical instrument from Optina Diagnostics, for the detection of beta-amyloid~     plaques, a hallmark of Alzheimer's disease (AD), in the retina. The experimental device,~     produces multiple images of the retina when subjected to light in very specific colors~     (90-100 specific colors typically) and may be used to identify specific biomarkers based on~     their unique spectral signature. The retina is an extension of the brain and is the only~     optically accessible nervous tissue. The MHRC could represent a simple and non-invasive tool~     to facilitate the diagnosis of AD.~   "
11714|NCT03413488|"~     To compare the effect between the exercise intervention (strengthening exercise and~     stretching exercise) and exercise intervention with taping on decreasing round shoulder~     posture and improving symptoms in subjects with shoulder impingement syndrome/round shoulder~     syndrome.~   "
11130|NCT03421119|"~     The purpose of this study is to compare the efficacy and safety of liraglutide produced by~     CinnaGen company and Novo Nordisk liraglutide (Victoza®) in subjects with type II diabetes.~     Patients with Type II diabetes treated with two oral glucose-lowering agents for ≥ 3 months,~     aged between 30 to 65 years, HbA1c equal or greater than 7.5 and lower than 10, and BMI~     between 25 to 45 were included in this study.~      This study is a phase III, randomized, two-armed, parallel, double-blind, active-controlled,~     and non-inferiority clinical trial. Patients who enter the trial will be randomly allocated~     (1:1 ratio) to receive subcutaneous 1.8 mg daily injections of either Victoza® or~     CinnaGen-liraglutide. Doses of liraglutide will be up-titrated from 0.6 mg/day in the first~     week to 1.2 mg/day in the second, third and fourth weeks up to 1.8 mg/day from the beginning~     of the fifth week. Patients continue to receive 1.8 mg/day liraglutide until the end 26th~     week.~      The primary objective of this study is to assess non-inferiority of CinnaGen-liraglutide to~     reference liraglutide in terms of efficacy in patients with T2D. The secondary objectives of~     this study are to further compare the efficacy of CinnaGen-liraglutide to reference~     liraglutide and to assess the safety of CinnaGen-liraglutide to reference liraglutide.~   "
11131|NCT03421106|"~     The investigator proposes an evaluation of a randomized, sustainable intervention in 8~     intervention and 8 control pantries. We will enroll 272 clients at baseline and follow them~     for 1 year to assess changes in overall diet quality (the primary outcome).~   "
11132|NCT03421093|"~     The study was designed to evaluate effectiveness of the surgeries and adjuvant therapies~     after surgeries in the patients with lung malignant tumors~   "
11133|NCT03421080|"~     Hazardous alcohol consumption is common among people suffering from depression. There are~     effective Internet interventions that target hazardous alcohol consumption or depression~     separately but none that combine these online interventions without the involvement of a~     therapist. This study aims to evaluate the effects of combining an Internet intervention~     targeting hazardous alcohol consumption with one for depression on drinking and depressive~     symptoms.~   "
11134|NCT03421067|"~     This is a retrospective descriptive study using the American College of Surgeon's National~     Surgical Quality Improvement Program® (ACS NSQIP®) data to determine whether gynecologic~     surgeons are already meeting the recently recommended best practice of supporting the vaginal~     apex at time of hysterectomy for pelvic organ prolapse (POP).~   "
11135|NCT03421054|"~     Pilot, open non-controlled trial to assess the feasibility of implementing objective~     parameters as primary endpoints in a clinical trial with patients affected by knee~     osteoarthritis.~   "
11136|NCT03421041|"~     This study intends to solve the following problems: whether use dexamethasone can obviously~     decrease transplant cancelling probability in fresh embryo transplant cycle or not, reduce~     time and frequency going to hospital repeatedly for patients need frozen embryo transplant or~     not, and reduce the economic burden for patients or not; By comparing pregnancy rate of~     single transplant, hope to make clear in IVF-ET treatment for patients progesterone increases~     to a certain level whether it is a good choice to transfer fresh embryo after dexamethasone~     treatment, or frozen embryo transplant is better.~   "
11137|NCT03421028|"~     This study evaluates beneficial effects of biofeedback therapy in reducing pain and increased~     tension of masticatory muscles occurring in patients with sleep bruxism.~      During the study two functions of Biofeedback will be used: Functional Electro Stimulation~     (FES) delivering stimulation to relax masseter muscles and Electromyography Biofeedback~     (EMG-Biofeedback)- assisted training lowering the masseter muscle tension. The experimental~     group consists of adult subjects with sleep bruxism and masticatory muscles pain will be join~     to 8 meetings of FES and EMG-Biofeedback - assisted training and than compared to the control~     group consists of randomly enrolled adult subjects .~   "
11138|NCT03421015|"~     Developing a genetic study on localized or locally advanced prostate cancer. The aim of the~     study is to identify genomic alteration predictive of metastatic recurrence in the context of~     primary heterogeneity, by using the next generation sequencing (NGS) techniques.~      Identifying such biomarkers may be useful to detect a higher relapse risk, and thus lower the~     mortality rate.~   "
11139|NCT03421002|"~     The primary purpose of this study is to evaluate the pharmacokinetic profile of micafungin~     administered to neonates suffering from systemic candidiasis. This study will also evaluate~     the proportion of success and of failure of the therapy with micafungin among treated~     neonates and will identify a conversion factor to relate plasma levels of micafungin into~     capillary and venous blood measured through blood samples from the heel and from a peripheral~     vein, collected simultaneously. Safety of micafungin in neonates will also be assessed.~   "
11140|NCT03420989|"~     It is a blind randomized clinical trial of nutritional intervention in humans with a snack~     (seaweeds and carob), compared to a control snack without the bioactive ingredients studied~     but of similar nutritional composition, to evaluate the effect on the lipid profile, glycemia~     and Insulin resistance.~   "
11141|NCT03420976|"~     Study Synopsis~      This pilot study will determine the efficacy of a novel supplement protocol and low FODMAP~     diet for the treatment of small intestinal bacterial overgrowth (SIBO). The study will~     operate as a prospective, open label investigation, with an estimated sample size of 10~     patients.~      Patients diagnosed with SIBO by Dr. Nathan Morris, MD at Good Medicine Clinic (Oxford, Ohio)~     will be offered the opportunity to enroll in this study, if inclusion and exclusion criteria~     are met upon initial diagnosis. No control group will be assigned.~      The diagnosis of SIBO will be determined via assessment of clinical symptoms and the results~     of a lactulose breath test. After administration of the supplement therapy and adherence to a~     low FODMAP diet (8 weeks), the lactulose breath test will be repeated and symptoms~     re-assessed by Dr. Morris. The post-treatment lactulose breath test and all supplements in~     the protocol will be provided free-of-charge to enrolled patients. In addition, enrolled~     patients will not be billed for the mid-treatment office visit. Patient and/or patient~     insurance will be responsible for all other expenses, including but not limited to the~     initial breath test, all other office visits and travel.~   "
11175|NCT03420534|"~     to inspect relevant pharmacokinetic parameters and relative exploitation degree, with fasting~     and postprandial dosing bioequivalence test under the condition of the human body, provide~     the basis for registration filing.~   "
40270|NCT03039621|"~     The purpose of this study is to obtain additional data on efficacy and safety of Ergoferon in~     the treatment of acute respiratory viral infections in children aged from 6 months to 6~     years.~   "
11142|NCT03420963|"~     Any time the words you, your, I, or me appear, it is meant to apply to the potential~     participant.~      NK cells are specialized immune cells in the body that have been shown to kill tumor cells~     (including solid tumor cells) in the laboratory. Previous studies of NK cells in some cancer~     patients have suggested that they can be given without severe side effects and may help in~     controlling tumors.~      The goal of this clinical research study is to learn the recommended dose of donated natural~     killer cells that can be given to pediatric cancer patients with solid tumors after receiving~     chemotherapy (cyclophosphamide and etoposide). The safety of the NK cells given after~     chemotherapy will also be studied.~      In this study, the NK cells being used have already been donated/collected from cord blood~     (blood collected at birth from the afterbirth of healthy babies). They are then expanded,~     or grown, so that more NK cells can be made from a small sample and given to a patient.~      Cyclophosphamide and etoposide are standard chemotherapy drugs that are used in the treatment~     of pediatric solid tumors. In this study, the drugs are being given both to fight the cancer~     cells and also to help prevent your body from rejecting the NK cells.~      This is an investigational study. NK cell transplants are not FDA approved or commercially~     available. Cyclophosphamide and etoposide are FDA approved and commercially available for the~     treatment being used on this study. The use of NK cell transplants in combination with this~     chemotherapy is investigational.~      The study doctor can describe how the study drugs and NK cells are designed to work.~      Up to 32 participants will be enrolled on this study. All will take part at MD Anderson.~   "
11143|NCT03420950|"~     This is a randomized, blinded trial comparing the order of drug administration for rapid~     sequence intubation in the Emergency Department.~   "
11144|NCT03420937|"~     The aim of this project is to show, whether the use of the deep neuromuscular block in~     certain laparoscopic robot-assisted surgery can positively influence main physiological~     functions compared to the use of standard neuromuscular block. Secondary outcome is to find~     out whether the targeted specific reversal of neuromuscular block by sugammadex improves and~     fastens the post-operative recovery of the patients.~   "
11145|NCT03420924|"~     The aim of this clinical investigation is to prove that the thermal suit with forced-air~     warming is more effective to prevent inadvertent intraoperative hypothermia than conventional~     warming methods. The study group will have the thermal suit from arriving to the hospital~     until to the ward after surgery. In the operating theatre forced-air warming device will be~     connected to the trouser legs of the thermal suit and the device will be turned on during~     surgery. The control group will have normal hospital clothes. Intraoperative warming will be~     managed with the warming mattress and a forced-air warming blanket. The primary endpoint is~     core temperature after arriving to the post-anaesthesia care unit.~   "
11146|NCT03420911|"~     The aim of this study is to determine the level of pain and anxiety in patients who present~     to the emergency department with acute pain, and to investigate the effect of the standard~     analgesic treatment and an additional anxiolytic treatment on pain and anxiety.~   "
11147|NCT03420898|"~     Inappropriate prescription of unnecessary and potentially harmful medications continues to be~     a widespread problem for hospitalized patients. The investigators aim to study the~     prescription patterns of several classes of medications featured both in the Canadian~     Choosing Wisely campaign and the Beers Criteria for medication1,2. Specifically, this study~     will be looking at the patterns of sedatives (includes benzodiazepines, sedative-hypnotics,~     and sedating antipsychotics) prescriptions over time.~      The investigators aim to determine how closely these recommendations are adhered to on~     medical-surgical wards at five local hospitals (Sinai Health System, Toronto General~     Hospital, Toronto Western Hospital, Sunnybrook Health Sciences Center, and St. Michael's~     Hospital); and to observe trends in prescribing before and after hospital-wide quality~     improvement initiatives.~   "
11148|NCT03420885|"~     Many researches shows that Ba Duan Jin has clinical efficacy on cancer rehabilitation,~     respiratory diseases, psychological health, quality of life and so on. Studies examining the~     effects of Ba Duan Jin on patients with pulmonary nodules are sparse. Therefore, the aims of~     the present study are: 1) to examine the effects of Ba Duan Jin on physical and psychological~     condition, and 2) to examine the effects of Ba Duan Jin on quality of life.~   "
11149|NCT03420872|"~     Background: Adequate levels of beneficial nutrients are important for neurodevelopment.~     Although, nutrients are ingested in combination, considering nutrients as a mixture has not~     been studied with respect to health, such as neurodevelopment.~      Objective: To examine the impact of prenatal and childhood nutrition mixtures on~     neurodevelopment.~      Design: Participants included mother-child pairs in the Programming Research in Obesity,~     Growth Environment and Social Stress (PROGRESS) prospective birth cohort in Mexico City.~     Prenatal and child nutrition profiles were assessed among 65 and 329 children respectively by~     analyzing components of a food frequency questionnaire. Child neurodevelopmental outcomes at~     4-6 years of age were measured using the McCarthy Scales of Children's Abilities (MSCA).~   "
11150|NCT03420859|"~     A prospective cohort study in IVF patients at 5 IVF centres in Denmark. The primary aim is to~     include patients positive for abnormal vaginal microbiota to an RCT. Secondary aims are the~     prevalence of abnormal vaginal microbiota in women undergoing IVF treatment, intimate hygiene~     and relations to the vaginal microbiota, basic fertility work up in relation to vaginal~     microbiota.~   "
11151|NCT03420846|"~     This Interventional Randomised Controlled study is intended to establish that presurgical~     margin mapping of BCCs with OCT results in a reduction of the number of MMS surgery stages~     without adversely impacting clinical outcome, resulting in shorter patient stays and more~     efficient use of surgical and operating room resources.~   "
11152|NCT03420833|"~     The purpose of this study is to gather information on the safety and effectiveness of cardiac~     resynchronization therapy (CRT) in patients who have mild heart failure (HF) and left bundle~     branch block (LBBB).~   "
11153|NCT03420820|"~     This is a randomized controlled single blind prospective study evaluating the efficacy of~     ocular surface sterilization between three different povidone-iodine preparation techniques~     prior to intravitreal injection. The primary end point is significant different between~     median colony-forming units pre- and post-sterilization and injection.~   "
11778|NCT03412656|"~     The trial is designed to test the effectiveness of a force-feedback cuff in combination with~     a myoelectric prosthesis in conveying information on grasp strength to the user, as well as~     the user's preference regarding the feature.~   "
11155|NCT03420794|"~     This is a randomized controlled trial comparing pre-admission administration of routine oral~     preoperative non-narcotic analgesics with the administration of these medications in the~     pre-anesthesia care unit per our standard practice. Patients will be screened, enrolled,~     consented, and randomized during the preoperative office encounter, typically occurring~     within the 30 days prior to surgery. Patients randomized to pre-admission administration~     (study group) will be provided with a prescription for a one-time dosing of routine oral~     non-narcotic analgesic medications to be filled at the Cleveland Clinic outpatient pharmacy.~     Both the study and the control groups will receive written pre-operative instructions. Those~     patients randomized to the standard practice of administration in the pre-anesthesia unit~     (control group) will be administered the same medications in the same doses by the nursing~     staff.~      Patients in both groups will undergo general anesthesia, orogastric tube placement, and~     minimally invasive hysterectomy (MIH). Post-operatively, patient pain will be assessed via~     NRS at standard intervals and treated with narcotics. Amount of total intravenous (IV) and~     oral (PO) narcotics given during PACU stay will be documented in the medication~     administration record (MAR) within the electronic medical record (EMR) and later converted~     into oral morphine equivalents (OME). Pain will be assessed via NRS on discharge and~     documented.~      Patients will be emailed on POD10 a survey to rate their satisfaction with their medication~     administration regimen on a 5-point Likert scale. Participants will also be asked to complete~     a thirteen-point surgical recovery scale (SRS) to evaluate their functional recovery from~     MIH.~      Patient participation will conclude after completion of the patient satisfaction survey and~     SRS. A maximum of 58 patients will be enrolled into the study, as we aim to randomize 26~     patients to each arm.~   "
11156|NCT03420781|"~     A 46-week study to compare the efficacy of relamorelin with that of placebo in participants~     with diabetic gastroparesis (DG). At the end of the 40-week Treatment Period, participants~     will either continue on relamorelin or placebo for 6 additional weeks.~   "
11157|NCT03420768|"~     This is a study of experimental medication BMS-986263 in adult patients with advanced hepatic~     fibrosis (scar tissue in the liver caused by inflammation that is far on in progress) after~     the patient is cured of hepatitis C (an infection caused by a virus that attacks the liver~     and leads to inflammation).~   "
11158|NCT03420755|"~     This project is aimed at enhancing the effectiveness and scalability of the Mothers and~     Babies 1-on-1 Course (MB) among home visiting programs. MB is a manualized 12-session~     postpartum depression prevention intervention guided by cognitive-behavioral therapy and~     attachment theory. Each session lasts 15-20 minutes and is delivered as part of a regularly~     scheduled home visit. Previous MB trials suggest that the intervention is less successful for~     women who exhibit smaller changes in hypothesized intervention mechanisms and less fully~     engaged in completion of personal projects. This study will determine the feasibility and~     acceptability of conducting MB-TXT, in which home visiting clients receive MB supplemented by~     a series of weekly text messages focused on skill reinforcement, personal project reminders,~     and self-monitoring of depressive symptoms. The investigators will also calculate a~     preliminary effect size that could be used to calculate sample size necessary for a future~     fully powered randomized controlled trial that examines MB-TXT efficacy. The investigators~     will use a stepped wedge design—a form of randomized controlled trial that involves~     sequential, but random, roll-out of the intervention over multiple time periods. The~     investigators have created two HV program clusters. Both clusters will initially implement MB~     1-on-1 and will recruit MB participants for one quarter (i.e., three months) before crossing~     over to recruit MB-TXT participants for one quarter. MB-TXT's core curriculum is identical to~     MB 1-on-1 and adds a series of text messages throughout the curriculum. Feasibility and~     acceptability data will be collected from clients and home visitors to assess percentages of~     received text messages, home visitor adherence to sending texts at specified intervals, and~     clients' perceptions of text message utility and clarity. If the investigators are able to~     integrate MB-TXT and home visiting programs and generate improved mental health outcomes for~     clients, the investigators will be prepared to replicate this intervention across home~     visiting programs nationally at a time when home visiting as a service delivery model is~     rapidly proliferating via federal Maternal Infant and and Early Childhood Home Visiting~     (MIECHV) program funding.~   "
11159|NCT03420742|"~     The purpose of this study is to characterize the effect of repeat-dose administration of~     brigatinib 180 milligram (mg) once daily (QD) on the single-dose pharmacokinetics (PK) of~     midazolam.~   "
11160|NCT03420729|"~     Dyspepsia is a common presenting complaint that doctors have to manage and this is true both~     in the primary and secondary care setting. OGD is a useful test for investigating a variety~     of suspected upper GI disorders including dyspepsia. However, it is uncomfortable for~     patients and incurs the risk of intubation and sedation. Capsule endoscopy (CE) is the~     investigation of choice for diseases of the small bowel. It is safe, non-invasive and well~     tolerated, the main risk being capsule retention occurring in up to 1-2% of procedures.~      The investigators wish to undertake a prospective study comparing acceptability and~     tolerability of MACE and OGD in the investigation of dyspepsia. Patients presenting to~     general practice or the outpatients department with symptoms of dyspepsia who are referred~     for investigation are invited to take part in the study. Patients will undergo MACE prior to~     OGD performed by an endoscopist blinded to the MACE findings. . A comparison of tolerance and~     acceptance of both procedures will be measured by means of using structured and validated,~     qualitative questionnaires. The aim is to assess for whether there is a significant~     difference between the perception and experience of both modalities.~   "
11161|NCT03420716|"~     Prebiotics have been linked to increased calcium absorption in animal and human studies~     (particularly in adolescents and in premenopausal women). Similarly, probiotics have been~     found to benefit calcium homeostasis in pregnant women, and to promote bio-mineralization in~     animal models. The effect of symbiotic on calcium absorption has been tested in rats, but not~     in human studies. The primary objective of this study is to investigate the effect of daily~     consumption of a functional symbiotic yogurt containing inulin and Lactobacillus rhamnosus~     compared to a control yogurt, on calcium absorption in young adult women. A secondary~     objective is to relate changes in calcium absorption following yogurt consumption, with~     calcium metabolism, vitamin D status, bone mass, calcium intake and overall composition of~     habitual diet.~   "
11162|NCT03420703|"~     Erector Spinae Plane Block is a newly defined regional anesthesia technique. Its use for many~     indications has been identified by case reports in the literature. As the investigators have~     considered that erector spinae plane block could be efficacious for providing postoperative~     analgesia in laparoscopic cholecystectomy, the investigators have implemented application of~     this blockade into practice at the clinic. Main purpose of this study is to evaluate the~     analgesic effect of ultrasound guided erector spinae block in laparoscopic cholecystectomy.~   "
11163|NCT03420690|"~     Negative symptoms in cancer in palliative care, such as pain, can lead to a withdrawal that~     can lead to a form of social exclusion. Maintaining pre-illness relationships is often~     difficult for the patient, especially since he is often not available to relationships.~      Art therapy defined as the exploitation of artistic potential in a therapeutic and~     humanitarian aim can contribute to the reduction of symptoms, to adaptation and to~     well-being. A recent review shows that positive affective states and meaningful social~     connections are important factors contributing to more effective adaptation to pain. Study~     hypothesis is that art therapy could play on these two factors.~      The objective of the qualitative study is to measure, using a questionnaire, the indirect~     impact of art therapy sessions on parents, during support and after death, from a relational~     and emotional point of view.~   "
11164|NCT03420677|"~     Sleep, specifically deep sleep, plays a central role in healthy brain function,~     cardio-vascular processes, mood and quality of life. Auditory stimulation during one night of~     sleep has previously been shown to improve deep sleep and along with memory formation in both~     young and older adults. Yet, it remains unclear whether long-term auditory stimulation~     considerably improves sleep quality over longer time periods and how it affects daytime~     functioning such as cognition, mood, quality of life and peripheral functions (e.g.~     cardio-vascular). Due to the importance of deep sleep for brain and body and the presence of~     many conditions that involve reduced deep sleep (e.g. ageing) assessing the beneficial impact~     of long-term sleep enhancement and its consequences is of central interest.This study will~     assess the effect of auditory stimulation over two weeks (interleaved with a two weeks~     washout period) in a cohort of healthy young and older adults using portable recording and~     stimulation devices.~   "
11165|NCT03420664|"~     In this study we are going to measure the blood flow in the lower limbs under cast~     immobilisation and also under mobilisation with an orthosis. The aim is to evaluate how the~     aforementioned modalities affect the blood flow and also to compare between the two.~   "
11166|NCT03420651|"~     Patients presenting to the emergency department with acute asthma exacerbation will be~     assigned to peak-expiratory flow rate (PEFR) guided management and non-PEFR guided~     management.~   "
11167|NCT03420638|"~     Tonsillectomy is one of the most commonly performed surgical procedures in the United States.~     The primary indications for tonsillectomy in the adult population include recurrent~     pharyngitis, chronic tonsillitis, and obstructive pathology. Tonsillectomy is often~     associated with severe postoperative pain, which can result in prolonged poor oral intake,~     dehydration, and the need for high dose narcotics. In severely dehydrated patients,~     epithelial shedding and necrosis of soft tissues at the surgical site can lead to~     postoperative complications such as bleeding, delayed healing, and severe pain. The goal for~     this study is to explore the use of a long acting local anesthetic bupivacaine liposome~     injectable suspension (Exparel) to manage pain experienced by adult patients after~     tonsillectomy. The proposed investigation will examine whether Exparel (bupivacaine liposome~     injectable suspension 1.3%—13.3 mg/mL) when used as a post-excision adjunct to the standard~     of care bupivacaine HCl 0.25% (2.5 mg/mL) with Epinephrine (5mcg/mL), will decrease the~     patient's post-tonsillectomy experience of pain intensity, especially for the first three~     days after surgery, and correspondingly reduce the requirement for pain medications and~     improve outcomes.~   "
11168|NCT03420625|"~     In this study, four different devices which stimulate the blood in the lower extremities are~     used in ten healthy persons while measuring the blood flow with ultrasound. The aim is to~     study the haemodymamic effects in the lower extremities of each modality and also to compare~     those effects between the four modalities in order to identify those which most effective~     than the others.~   "
11169|NCT03420612|"~     Colonoscopy is the gold standard in the diagnosis and treatment colorectal disease, but due~     to the uncomfortable or even painful procedure, a part of people unwilling to undergoing the~     examination and giving analgesic agents were recommended in several guidelines. However, use~     of analgesic agents have their own drawbacks, and nearly 70% patients felt no pain or only~     mild discomfort with the unsedated colonoscopy, routine administration of sedative or~     analgesic agents to all patients was considered as unnecessary. However, unsedated~     colonoscopy was thought to be an option for some but not for all, therefore a method to~     identify which patients at high risk for painful colonoscopy in preoperational stage is~     necessary.~   "
11170|NCT03420599|"~     Studies has shown an increasingly infection rate after splenectomy, and there is a potential~     correlation between microbiota and immune system. investigators suppose that increasingly~     infection can be associated with the alteration composition of the gut microbiota after~     splenectomy. It's investigators' aim to discover if any difference of gut microbiota is exist~     in patients who suffer from traumatic splenectomy compared with normal people, ultimately aim~     toreduce and mitigation infection rate through controlling gut microbiota.~   "
11171|NCT03420586|"~     Addition of nitrous oxide N2O towards the end of prolonged isoflurane anesthesia hastens~     patients recovery. The hypothesis is that the addition of N2O at the end of prolonged~     sevoflurane anaesthesia also hastens early recovery without increasing the frequencies and~     intensity of PONV and improves quality of recovery.~   "
11172|NCT03420573|"~     There is association between Hepatitis C and Parkinson's Disease as shown from previous~     studies. The clinical profile and natural history is not fully studied yet. We aim at~     studying the clinical characteristics of Parkinson's Disease in patients with hepatitis C~     infection.~   "
11173|NCT03420560|"~     Propofol injection pain will be surfed by up to 70-80 percentage by the Patients who induced~     by propofol. Temperature of Operating room was set to a certain range in normal clinical~     practice, which is 22- 26 centigrade. Warm feeling will make skin vassal dilated and more~     blood will pass through to bring more heat out of our body. It had been reported that a~     bigger venous vessels will get less propofol injection pain.~      The investigators hypothesis that Patients who stayed in a warmer room temperature will surf~     less injection pain while compare to a normal setting room temperature.~   "
11174|NCT03420547|"~     Disturbances in marital intimacy and sexual health is one of the most underrated and~     undertreated problems in cancer survivorship. A review on unmet supportive care needs of~     cancer patients noted one third to more than half of patients reported support for sexual~     disturbances as an area of unmet need during and after treatment. Patients, whose sense of~     femininity and body image may be at risk, such as in the case of breast and gynaecologic~     cancers, may be more susceptible to such intimacy and sexual disturbances. According to a~     recent study conducted in Singapore, 25% of gynaecologic cancer patients reported~     dissatisfaction with their bodies and 19% reported feeling less sexually attractive.~     Unfortunately, there is paucity in formal resources for couples counselling within the~     oncology setting in Singapore. The current study seeks to investigate a pilot program called~     Renewing Intimacy and Sexuality (RISE), which consists of 3 sessions with female cancer~     patients and their spouses, and that combine components of psychosexual education,~     communication training and skills building. The reach, acceptability, implementation, and~     preliminary effectiveness of the RISE program will be assessed based on the RE-AIM framework~     for program planning. The overall aim of the research project is to establish evidence-based~     programs for cancer survivors to enhance their quality of life.~   "
11176|NCT03420521|"~     This is a single arm open-label design study looking at Nivolumab plus Ipilimumab in patients~     with Advanced Neuroendocrine Tumors. Patients will be dosed Nivoluma 240mg IV over 60 minutes~     every 2 weeks and Ipilimumab 1mg/kg IV over 30 minutes every 6 weeks. Once cycle will include~     3 doses of Nivolumab and 1 dose of Ipilimumab. The objective of this study is to evaluate the~     objective response rate of combination nivolumab and ipilimumab in advanced,~     well-differentiated neuroendocrine tumors. Durability of response, and PFS will also be~     described.~   "
11177|NCT03420508|"~     The purpose of this study is to test the effects of the study drug, ensartinib, on the~     patient and the cancer. Ensartinib is a new, investigational type of treatment for melanoma~     with a particular type of abnormality.~   "
11178|NCT03420495|"~     The investigators are examining whether conditions of ambiguity during decision-making may~     prime intolerance of uncertainty beliefs (i.e., difficulties coping with ambiguity,~     unpredictability, and the future) and lead to impaired performance when individuals with~     obsessive-compulsive disorder (OCD) are making uncertain decisions compared to~     non-psychiatric controls.~   "
11179|NCT03420482|"~     A common complication of advanced liver disease is a condition called hepatic encephalopathy,~     which leads to confusion. The current treatment options cause side effects, are costly, and~     do not always work. An abnormal population of bacteria in the intestines may be causing this~     condition, and transplanting bacteria from the colon of a healthy person may treat it. In~     this research study, the investigators will first find two healthy stool donors whose stool~     donation improves the gut bacteria of patients with advanced liver disease and helps them~     think more clearly. Then, in a randomized controlled trial, the investigators will compare~     the ability of stool donation from these two best donors versus a placebo to improve the~     neurological function of patients with advanced liver disease. If the investigators find the~     expected results, there will be a new effective therapy for patients with advanced liver~     disease and the very troublesome complication of hepatic encephalopathy.~   "
11180|NCT03420469|"~     Primary objectives:~        1. To comprehensively characterize steady state stereoselective pharmacokinetics of~          bupropion and its primary and secondary metabolites in healthy volunteers~        2. To prospectively determine the time course (onset), extent and offset of CYP2D6~          inhibition in relation to the pharmacokinetic profiles of bupropion and metabolites.~   "
11181|NCT03420456|"~     Transcranial Light Therapy involves non-invasive and invisible beams of light that increase~     energy metabolism in the brain. Transcranial light therapy has been found to promote brain~     metabolism which may help people with anxiety. The research team proposes a novel approach to~     treating anxiety by using transcranial light therapy.~   "
11182|NCT03420443|"~     The aim of this study is to investigate how bacteria and fibre interact with the epithelial~     cells of the gastrointestinal mucosa to reduce inflammation and to diminish tissue damage~     caused by radiation therapy to patients diagnosed with rectal cancer.~   "
11183|NCT03420430|"~     GL-ONC1 expanded access is for patients who are ineligible for an ongoing GL-ONC1 clinical~     trial. Expanded access is intended to treat individual patients with advanced stage cancers,~     including blood cancer, with no standard of care options for treatment. Potential patients~     will be evaluated individually depending on GL-ONC1 product supply.~   "
11184|NCT03420417|"~     This study aims at assessing the respiratory mechanics of intubated patients in intensive~     care unit.~   "
11185|NCT03420404|"~     A pragmatic, prospective, randomized controlled trial will be conducted in patients with~     axial spondyloarthritis who are NSAID inadequate responders. Patients will be randomized in a~     1:1 ratio to either receive standard rheumatological care or a Traditional Chinese Medicine~     physician involved collaborative model of care (i.e. NSAIDs with acupuncture). Primary~     end-point was spinal pain score at week 6 with secondary end-points being evaluated week 24.~     Through this study, we hope to assess a novel model of care in AxSpA and be used as a~     reference to improve the management of other chronic diseases in Singapore.~   "
11186|NCT03420391|"~     Recent studies with photobiomodulation therapy (PBMT) have shown positive results delaying~     skeletal muscle fatigue and improving the status of biochemical markers related to skeletal~     muscle damage when these therapies were applied before exercise. The aim of this project was~     to verify the effects of PBMT in improvement of skeletal muscle performance and skeletal~     muscle recovery in healthy male subjects. This project aimed also to validate the concept~     that simultaneous use of three wavelengths and light sources lead to optimized action~     independently of time-window between irradiation and the exercise. It was performed a~     randomized, double-blinded, placebo-controlled trial, with voluntary participation of healthy~     subjects. Investigators analyzed parameters related to volunteers exercise performance (peak~     torque through maximum voluntary contraction - MVC), delayed onset muscle soreness (DOMS) by~     visual analogue scale (VAS), and biochemical marker of muscle damage (CK). Analysis were~     performed before exercise protocol (baseline) and the phototherapy was applied after 3~     minutes from baseline. The eccentric exercise protocol was done after 5 minutes, 3 hours, 6~     hours and 24 hours from PBMT. Then the assessments were repeated after 1 minute from~     exercise, and 1, 24 and 48 hours after the end of exercise protocol.~   "
11187|NCT03420378|"~     The purpose of this study is to investigate the presence of central sensitization in vitamin~     D deficiency and its effect on cutaneous silent period, pain, and quality of life. The~     secondary purpose of the study is to investigate whether a change in cutaneous silent period~     parameters, pain severity and neuropathic sensitization and quality of life after vitamin D~     replacement.~   "
11188|NCT03420365|"~     Individuals of advanced age are at higher risk of cognitive deterioration.A single bout of~     aerobic exercise was found to improve cognitive functions. The aim of this study is to~     explore the effect of a single bout of balance and coordination exercise versus aerobic~     exercise on cognitive functions among elderly people.~   "
11196|NCT03420261|"~     The primary purpose of the study is to evaluate whether the type of fluid (0.9% saline or 6%~     Hydroxyethyl starch 130/0.4) in the context of an individualized goal-directed fluid therapy~     is associated with a difference in morbidity and mortality within the first 14 days in~     patients at moderate-to-high risk of postoperative complications after abdominal surgery.~      Further investigation include the analysis of hemostasis modifications according to the fluid~     group during the first 7 days after abdominal surgery.~   "
11189|NCT03420352|"~     The Department of Health recommends using equipment which prevents wrong route drug~     administration. However, the epidural blood patch requires equipment that connects to the~     intravenous and epidural route. To comply with these recommendations a non-Luer butterfly~     needle with one-way valve has been produced. The one-way valve and length of tubing has the~     potential to activate the clotting cascade. This could reduce the time clinicians have to~     utilise the blood in the syringe. Also any alteration in clotting could affect the~     therapeutic value of the epidural blood patch. The primary objective of this research was to~     determine if phlebotomy using this new 21G needle altered blood clotting, determined by~     thromboelastograph analysis, compared to a standard 21G hypodermic needle.~   "
11190|NCT03420339|"~     The goal of this study is to determine the effects of stimulant medication on disruptive~     behavior, function, preference and choice; however, it is primarily methodological and will~     add to current research by establishing an effective evaluation of the impact of stimulant~     medication on these behaviors. Three behavior assessments for children and adolescents~     diagnosed with AD/HD who exhibit disruptive behavior will be conducted:~        1. Preference assessments will be conducted to determine whether preference for social and~          nonsocial items and activities differs under medication and non-medication conditions.~        2. Functional analyses will be conducted to determine whether stimulant medication has an~          effect on the frequency and function or purpose of disruptive behavior.~        3. Choice assessments will be conducted to evaluate the impact of stimulant medication on~          impulse control/delay discounting.~      This study will be conducted in three phases. For each of the 5 to 10 participants there will~     be 8 total visits. The first 4 visits will entail a preference assessment, followed by a~     functional analysis. On visits 1 and 3, the participant will be asked to take his/her~     stimulant medication as is typically done; however, on visits 2 and 4, the participant will~     be asked to refrain from taking the medication.~      For visits 5-8, participants will continue to participate in preference assessments, but will~     also be presented with a choice arrangement with work and play. In the choice arrangement,~     participants will be given four work cards and four play cards that they can organize in any~     order. Work cards will be associated with a brief academic task and play cards will be~     associated with a brief play period using high-preferred toys/activities. On visits 5 and 7~     the participant will be asked to take his or her stimulant medication as usual, while on~     visits 6 and 8 the participant will be asked to refrain from taking his or her medication.~   "
11191|NCT03420326|"~     Atrial fibrillation (AF) is the most common arrhythmias in clinical practice. Research~     investigating hospitalized patients have indicated there are deleterious effects of AF on~     patients besides the disease burden itself, including longer stay days for hospitalization,~     higher rates of frailty and increasing mortality rate after discharged in six months. In the~     community-dwelling research also found that elderly with AF have lower cognitive function,~     physical functional tests score and slower walking speed compared with the health ones.~     However, there is limited articles investigating the impact of AF on community-dwelling~     elderly, and the relationship between AF and frailty is also lack of discussion. According to~     the aged society and increasing prevalence of AF, the relationship between AF and frailty in~     community-dwelling elderly is warranting investigated.~   "
11192|NCT03420313|"~     Despite the demonstrated effectiveness of agonist treatment for opioid dependence and~     alarming recent increases in overdose deaths, waiting lists for treatment persist. In a~     Behavioral & Integrative Treatment Development pilot study, the investigators demonstrated~     the initial efficacy a novel Interim Buprenorphine Treatment (IBT) to mitigate the risks~     (e.g., illicit opioid use, IV drug use) associated with treatment delays. However, consistent~     with that R34 mechanism, our initial pilot study involved a limited sample size and was~     conducted at a single academic, well-controlled research clinic with an extensive history of~     research.~      It is important to replicate these very positive pilot results and begin to evaluate whether~     they generalize to less-controlled rural environments that are being so adversely impacted by~     the current opioid abuse epidemic. In this Stage II randomized parallel two-group trial, the~     investigators will evaluate the efficacy of IBT using a larger sample of 200 waitlisted~     opioid-dependent adults. UVM will serve as the coordinating center and primary recruitment~     site where the research team will enroll 100 participants (50 IBT, 50 WLC). The investigators~     will partner with health centers in rural Vermont counties to enroll the remaining 100~     participants (50 IBT, 50 WLC). The proposed research builds directly on the promising Stage I~     results and has the potential to substantially reduce the vast individual and societal costs~     associated with opioid treatment delays.~   "
11193|NCT03420300|"~     Hepatitis C virus (HCV) infection is common in patients receiving hemodialysis. The uptake of~     antiviral therapy for these patients is limited in the era of interferon (IFN) plus ribavirin~     (RBV), probably because the sustained virologic response (SVR) rates are low and the risk of~     treatment-related adverse events (AEs) are high. In the era of IFN-free direct acting~     antiviral agents (DAAs), several studies have indicated high rates of SVR and excellent~     safety profiles to treat patients with severe renal impairment. With regard to~     elbasvir/grazoprevir (EBR/GZR) treatment, a phase 3 study (C-SURFER) study has shown 99% of~     SVR in HCV-1 patients with chronic kidney disease (CKD) stage 4 or 5. Furthermore, most~     patients tolerated the treatment well. Although the data confirmed the excellent safety and~     efficacy in HCV-1 patients with severe renal impairment, data regarding the safety and~     efficacy for Asian HCV-1b patients receiving hemodialysis is lacking. Therefore, we aim to~     evaluated the safety and efficacy of EBR/GZR for 12 weeks in treatment-naive and~     treatment-experienced HCV-1b patients receiving hemodialysis.~   "
11194|NCT03420287|"~     The aim of this trial is to figure out the efficiency of Mineralized Plasmatic Matrix~     prepared from allogenic bone graft on cleft alveolus and oro-nasal fistula closure, adequate~     bone volume and acceptable density at the site of grafting.MPM might improve the~     physiological properties of allogenic bone graft and facilitate its handling and application~     during surgical grafting.This might decrease the need of the second surgical site for~     harvesting autogenous bone to be grafted with its all complications and hurdles.This trial~     will help the practitioners in taking the decision of using the MPM prepared from allogenic~     bone in alveolar cleft closure or not.~   "
11195|NCT03420274|"~     Noninvasive prenatal genetic testing (NIPT) is an important new screening test option~     provided to pregnant women in the first trimester of pregnancy. The advantage of this screen~     is that is provides information about the risk of trisomy 13, trisomy 18, and trisomy 21 with~     greater accuracy than conventional screens. At the same time, NIPT can produce information~     about the risk of a cohort of other fetal genetic variants, including sex chromosome~     aneuploidies and microdeletion syndromes. While not yet clinically available for whole exome~     sequencing, the potential for this next clinical application already exists. The challenge is~     that, while this is an important new test, there are little data about how to best structure~     patient-centered decisions about its use, including decisions if to use this screen and how~     the information may directly inform subsequent prenatal care decisions. The purpose of this~     study is to gain formative data about current practice patterns with respect to how NIPT is~     discussed in the clinical visit and to use these data to help inform best practices for its~     continued use in the clinical setting.~   "
11200|NCT03420209|"~     Cystic fibrosis and bronchiectasis are the most seen problems in children with chronic~     pulmonary diseases. İt is a genetic, chronic system disease that reduces life expectancy, and~     life quality as well. Chronic lung disease , malnutrition, and reduced activity, caused by~     disease lead to postural disorders. Muscle force, endurance, activity of Daily living are~     adversely affected. İn the treatment pulmonary rehabilitation are using. Airway clearance~     technique, pulmonary exercises, upper extremity ergometer, dumbbells, elastic bands,~     proprioceptive neuromuscular facilitation technique are applying. Resistance training using~     elastic bands has become an increasingly common intervention aiming to improve function by~     increasing muscular strength. İn one study indicated that muscle strength can be improved~     through three dimensional spiral large scale resistive exercises using proprioceptive~     neuromuscular facilitation. İn the literature there isn't any research , uses elastic bands~     with proprioceptive neuromuscular facilitation for the upper extremity and evaluating~     pulmonary functions, posture, quality of life, muscle force.~      The aim of this study is giving exercises programme with proprioceptive neuromuscular~     facilitation and elastic bands and to evaluate pulmonary muscle force, pulmonary functions,~     posture, activity of daily living, quality of life, functional capacity. And to evaluate the~     effect of treatment programme on these parameters.~      The subjects were divided in two groups. An experimental group three times a week for 12~     weeks will perform proprioceptive neuromuscular facilitation exercises with elastic bands,~     and pulmonary exercises. The control group will apply only pulmonary exercises at home~     programme.~   "
11201|NCT03420196|"~     This study compares the efficacy of a supervised rehabilitation program vs a non supervised~     rehabilitation program on pain, disability, quality of life and kinesiophobia in patients~     with non-specific low back pain.~   "
11202|NCT03420183|"~     This is a Phase 1b/2 study to investigate the safety and effectiveness of the investigational~     drug, cirmtuzumab, when given in combination with ibrutinib in patients with B-cell lymphoid~     malignancies. Cirmtuzumab is a monoclonal antibody that attaches to a protein (called ROR1)~     that is found on hematologic tumor cells. ROR1 has been shown to play a role in cell~     signaling that cause leukemia cells to grow and survive. ROR1 is rarely found on healthy~     cells.~   "
11203|NCT03420170|"~     This is a single blind randomized controlled trial study which will conducted on people with~     paraplegia wheelchair users. The objectives of this study is to investigates the effects of~     16 weeks of 'Graded Exercise Integrated Education' over conventional physical therapy on~     physical fitness, exercise self-efficacy and the level of physical activity. There will be a~     significant difference between the experimental and control group.~   "
11204|NCT03420157|"~     Despite the existence of an effective screening test (pap smear), cervical cancer is, every~     year in France, the cause of more than 3,000 new cases and 1,100 deaths. But, in France, 4 in~     10 women are not screened or not often enough (nearly 7 millions women). It is therefore~     necessary to develop new strategies to reach these women. The etiological factor of this~     cancer is persistent infection with oncogenic High-Risk Human PapillomaVirus (HR-HPV).~     Thereby, HPV-based tests could be alternative screening tests. Vaginal self-sampling with~     HR-HPV test is simpler and less intrusive than the pap smear. It has been shown that vaginal~     self-sampling with HPV test is a powerful means to increase the participation rate in~     cervical cancer screening. The investigators hypothesize that it is possible to optimize~     participation rate by improving the communication media associated to the vaginal~     self-sampling kit. This is why the accompanying letter and the leaflet explaining how to~     perform the vaginal self-sampling will be submit to women opinion by using the Focus Group~     method. The objective is to identify improvement ideas of these two communication media.~   "
11205|NCT03420144|"~     Liver cirrhosis (LC) is a leading cause of morbidity and mortality worldwide. Life-~     threatening complications of liver cirrhosis are ascites, gastrointestinal bleeding, variceal~     bleed, hepatic encephalopathy and hepatocellular carcinoma (HCC) which are associated with~     poor prognosis.The leading causes of liver cirrhosis include excess alcohol consumption,~     viral hepatitis and non-alcoholic fatty liver disease. Malnutrition is common in end-stage~     liver disease (cirrhosis) and is often associated with a poor prognosis. It occurs in all~     forms of cirrhosis with different etiology and prevalence ranges from 65 to 100% depending~     upon the methods used for nutritional assessment and the severity of liver disease.~     Nutritional state influences survival in patients with decompensated cirrhosis. Protein~     malnutrition manifested by reduced skeletal muscle mass and hypoalbuminemia, exist in~     patients with cirrhosis despite apparent adequate food consumption and these patients have a~     higher rate of complications and, overall, an increased mortality rate. Also, Malnutrition~     has significant implications for liver transplantation; patients with poor nutritional status~     before transplantation have increased complications and higher mortality rates~     postoperatively. Screening all patients with chronic liver disease for nutritional~     abnormalities can identify those at risk of developing preventable complications.~      Malnutrition is commonly associated with protein catabolism and the protein catabolic state~     of cirrhosis is associated with severe growth hormone (GH) resistance, with low levels of~     insulin-like growth factor (IGF)-I and its major binding protein (IGFBP)-3.~      GH therapy in cirrhosis has been shown to improve nitrogen economy and to improve the GH~     resistance in a small pilot study by Donaghy et al. Also, GH therapy of short duration has~     shown to increase IGF1 levels, IGFBP-3 levels in patients of cirrhosis. GH therapy has also~     shown to improve liver regeneration and protein synthesis after hepatectomy in patients of~     HCC with cirrhosis.~      However there is scarcity of data on clinical impact of long term administration of GH~     therapy in patients of cirrhosis. Hence, we undertook the present study to study the effect~     of growth hormone on nitrogen economy, malnutrition and liver regeneration in patients with~     cirrhosis.~   "
11206|NCT03420131|"~     A Prospective, observational, single center diagnostic study to investigate the the~     diagnostic agreement between QFR and the pressure wire-based iFR in a real world setting.~   "
11207|NCT03420118|"~     In recent years, there has been a significant improvement in understanding the biology of~     cancer and this information has been used to improve cancer care and patient outcome.~      Research has shown that changes in some genes and/or proteins may be important indicators for~     certain cancers and response to treatments. Genes are molecules made up of ribonucleic acid~     (RNA) and deoxyribonucleic acid (DNA). DNA contain instructions for the development and~     functioning of the cells in the body and are passed down from parent to child. RNA is~     involved with producing proteins in the body. Further research is needed to better understand~     the changes found in cancer cells and how to target them to stop or reduce cancer growth.~      A drug that may be able to block certain specific cancer cell changes is called targeted~     therapy. Different people with the same type of cancer receiving the same drug could have~     different responses to it. For example, one person may experience a reduction of their tumor~     while another person's cancer may worsen. The reason for this is still not well understood~     and could lie in gene changes.~      Understanding these changes may allow researchers to predict how treatments may work in~     guiding decisions around choice of drugs.~      The purpose of the study is to learn more about gene changes or protein expression (levels)~     of tumors to better understand the behavior of gynecological diseases and, if possible,~     better address participants' cancer care now or in the future.~   "
11209|NCT03420092|"~     In this study, the relative bioavailability of different formulations of AZD5718 will be~     determined in order to compare it with the formulation used in a previous Phase 2a study and~     confirm appropriate drug exposure. This study consist of 2 parts. In Part 1, 5 different~     formulations of AZD5718 would be provided to the participant in fasting condition in a~     randomized order. After evaluation of Part 1 a single formulation would be selected for~     dosing in fed condition in Part 2. Each participant will be involved in the study for~     approximately 5 to 6 weeks. Fourteen participants will be randomized to ensure at least 10~     evaluable participants at the end of the last treatment period.~   "
11210|NCT03420079|"~     This phase I trial with dose-escalation stage and dose-expansion stage is the first-in-human~     study of FCN-411, a drug being developed for treatment of advanced cancers. The initial~     purpose of the study is to determine the maximum tolerated dose (MTD) and the recommended~     phase 2 dose (RP2D) of FCN-411 monotherapy in EGFR-positive mutation non-small cell lung~     cancer chinese patients. The study will also provide early information on how the body~     handles the drug (pharmacokinetics) and on the anti-tumor activities of FCN-411.~   "
11211|NCT03420066|"~     A Multicenter, observational Data Collection Study to Evaluate the Safety and Performance of~     the Nexus™ Aortic Arch Stent Graft System in patients that were implanted with the device as~     part of Compassionate Use Procedures.~   "
11212|NCT03420053|"~     This is a randomized, double-blind, placebo-controlled trial to evaluate safety and~     tolerability of PfSPZ Vaccine administered as five doses of 9.0x10^5 PfSPZ or normal saline~     at 0, +2, +4, +6 and +28 days to healthy HIV negative adult volunteers and healthy HIV~     positive volunteers in Tanzania.~   "
11213|NCT03420040|"~     A clinical study of the use of glargine insulin in 2 subjects with type two diabetes in China~     was carried out. The two kinds of injection methods were evaluated as subcutaneous injection~     of insulin glargine.~   "
11214|NCT03420027|"~     A seven-item simplified score (the MACOCHA score) has been validated to predict difficult~     tracheal intubation in intensive care unit patients. In the prehospital or in the emergency~     department settings, no such validated predictive score is available yet. The aim of the~     present study is to assess the feasibility the quick calculation of the MACOCHA score before~     emergent intubation, in the prehospital and emergency department contexts.~   "
11215|NCT03420014|"~     The present study is an open-label, randomized, controlled, two-arm multi-center study of the~     efficacy of L19TNF treatment in combination with doxorubicin versus doxorubicin alone in~     metastatic or unresectable soft-tissue sarcoma patients.~      In the study, 114 patients will be randomized in a 1:1 ratio to receive doxorubicin treatment~     (Arm 1) or L19TNF treatment in combination with doxorubicin (Arm 2).~      The primary objective of the trial is to evaluate if L19TNF in combination with doxorubicin~     (Arm 2) given for unresectable or metastatic soft tissue sarcoma improves efficacy measured~     as progression free survival, as compared to doxorubicin alone (Arm 1).~      Anti-cancer activity will be assessed every 6 weeks during therapy and every 12 weeks~     thereafter.~   "
11216|NCT03420001|"~     There is no data regarding the risk of levator ani avulsion in women after a vaginal birth~     after caesarean although a possible increased risk has been suggested. The aim of the study~     is to describe the incidence of levator ani avulsion and compare it to primiparous women. In~     addition, health related quality of life will be evaluated and compared~   "
11217|NCT03419988|"~     Advanced age is the main risk factor for chronic diseases such as cardiovascular disease,~     type 2 diabetes, Alzheimer's disease and cancer. One reason may be due to decreased~     resistance to oxidative stress as antioxidant defenses and cell protection is reduced with~     aging. This has been shown in animal studies and also that the impairment can be somewhat~     restored with exercise. This will be the first study to test this in humans by comparing~     young and older inactive adults before and after an exercise intervention, a practical and~     cost-effective intervention that can have tremendous public health impact by lowering risk~     for disease and medical-related costs.~   "
11218|NCT03419975|"~     TJO-002 or Acitve Control was administered on primary open-angle glaucoma or ocular~     hypertension patients for 12 weeks. This clinical trial study has hypothesize TJO-002~     administration groups are not inferior to Active control administration groups.~   "
11219|NCT03419962|"~     Open-label observational study: including COPD patients receiving treatment with Spiolto®~     Respimat® for approximately 6 weeks, which is the average time between two medical~     consultations~   "
11220|NCT03419949|"~     Breast cancer is the most frequent neoplastic tumor in women, and surgical treatment is~     indicated in most patients. Complications related to this treatment, such as post-mastectomy~     pain syndrome (PMPS), a persistent pain that develops after surgery, have been reported.~     Although the genesis of the pain is multifactorial, sectioning of the intercostobrachial~     nerve is the nerve lesion diagnosed more often (1) ..~      Pain relief using drugs with high efficacy provides significant improvement in the patients'~     lives. Drugs like lamotrigine (LTG) and gabapentin (GBP) have the ability to overcome the~     symptoms of neuropathic pain (4).~      Both LTG and PGB have been extensively reviewed in the past for management of painful~     neuropathic conditions (5)~   "
11221|NCT03419936|"~     The purpose of this study is to know the distribution of Helicobacter pylori in stomach~     before subtotal gastrectomy and after subtotal gastrectomy.~   "
11222|NCT03419923|"~     The aim of our study is to assess three anticoagulation strategies for intermittent~     hemodialysis(IHD) in patients at risk of hemorrhage. A registry of consecutive hemodialysis~     patients with high risk of hemorrhage were conducted at the Guangdong General Hospital, the~     First Affiliated Hospital of Guangzhou University of Chinese Medicine, the Second Affiliated~     Hospital of Guangzhou Medicine University or Guangzhou Hospital of Chinese Medicine, between~     October 1st, 2017 and June 30th,2018. In this multi-center prospective and randomized study,~     participants were randomly divided into three groups during IHD according to different~     anticoagulation, including with regular saline flushes, one stage regional citrate~     anticoagulation (RCA) and two-stage RCA.~   "
11223|NCT03419910|"~     This is an investigational study of Cyclosporine on the experimental medication BMS-986165 in~     healthy male participants.~   "
11224|NCT03419897|"~     This is a Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and~     Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Patients with Previously~     Treated Hepatocellular Unresectable Carcinoma.~   "
11227|NCT03419845|"~     For some patients with mobility issues, a walking frame (commonly known as a zimmer frame -~     trademark of Zimmer Holdings), is provided to keep them on their feet and help them remain~     more independent in their home and when out and about. When patients are given the walking~     frame, they are given information on how to use it safely to protect them from hurting~     themselves. For a small group of patients, using the walking frame is difficult, and they~     will have a fall because they are unable to use the frame safely. For these patients, a fear~     of falling can then develop and they can then have more falls. It is thought that these falls~     with the walking frame happen because the patient steps too far into the frame, making them~     unstable. We have made an attachment for a standard walking frame, which we are calling the~     Step Right Buddy, that we think will help improve the stability of patients who step too far~     into the frame. We have attached a detachable elasticated band across the back legs of the~     frame to make patients aware that they have stepped far enough into the frame, to stop them~     stepping any further. In order to develop this further, we need to understand how people feel~     using this adapted frame and whether there are any new risks to the user.~      The investigators propose to ask patients who are considered to be at risk of falling because~     of the way they use their walking frame if they would like to use the adapted walking frame~     in their home, instead of their standard frame, for a week. At the end of this week,~     investigators will spend up to an hour with this patient, talking with them about their~     experience of the adapted walking frame, in order to understand things such as how they felt~     using the frame, were they more or less fearful of using it than their usual frame, did they~     think they were going to fall over more or less often, do they think they fall more or less~     often. In addition to this, patients will keep a written record of when they thought they~     nearly fell, or when they had an injury whilst using the adapted walking frame. This~     information will be used to explore whether or not the adaption to the frame introduces new~     risks to patients.~   "
11228|NCT03419832|"~     There is evidence that the current design and content provided by most biomedical research~     informed consent documents do not consistently meet the expectations researchers place on~     them to effectively inform research participants of information thought to be most important~     in facilitating their ability to make informed decisions about participation. The need for~     revisions to the informed consent document design is supported by empirical research.This~     pilot study will examine the effectiveness of the New Executive and Appendix Template (NEAT)~     form when used in the consent process for individuals participating in the Atherosclerosis~     Risk in Communities (ARIC) Neurocognitive Study.~   "
11229|NCT03419819|"~     A prospective, open-label study of PKU Sphere in patients with PKU following a phenylalanine~     restricted therapeutic diet.~   "
11230|NCT03419806|"~     In patients with Parkinson's disease, the characteristic motor symptoms, i.e., slowness of~     movement (bradykinesia), tremor and rigidity, are consequences of the progressive~     degeneration of neurons containing and releasing dopamine. The first-line treatment of~     Parkinson´s is oral administration of levodopa - a precursor to dopamine that (unlike~     dopamine) passes the blood brain barrier. After the first few years of treatment with~     levodopa, many patients do however develop a highly variable response to the drug~     characterised by rapid shifts between impaired locomotion and drug induced dyskinesias~     (referred to as the on-off syndrome). This is cased by the marked variation in serum levodopa~     levels following per oral administration, and it is known that intravenous administration of~     levodopa give a more stable level of levodopa with improved on-off symptoms.~      Levodopa-carbidopa intestinal gel (LCIG) - under the name of Duodopa® - is delivered directly~     to the proximal jejunum via a tube connected to a portable infusion pump. Infusion of Duodopa~     in the jejunum bypasses gastric emptying, helping to avoid the fluctuation in plasma levodopa~     levels. However, while clearly confirming that an even administration of levodopa is of~     considerable benefit to Parkinson patients with on-off symptomatology, the LCIG approach is~     marred by the need for surgery (for the insertion of the intestinal tube) and various~     possible complications following this, as well as by side effects such as abdominal pain.~      Researchers have now succeeded in producing a physiologically acceptable levodopa solution~     (called Infudopa) in a concentration allowing for a continuous intravenous (i.v.) or~     subcutaneous (s.c.) administration of therapeutic doses to humans. Early experience of this~     strategy confirms that both s.c. and i.v. administration of this solution results in even~     serum levodopa levels and markedly improved motor functioning. The aim of this study is to~     compare the pharmacokinetic profile of Infudopa administered i.v. and s.c. with that of~     Duodopa administered enterally in parkinsonian patients with on-off complications.~   "
11231|NCT03419793|"~     Background and objective: Upper extremity functional impairments are common consequences post~     stroke. The aim of this study was to investigate the influence of Segmental muscle vibration~     (SMV) application along with supervised physical therapy (SPT) on improving activities of~     daily living (ADL) and motor recovery on the hemiparetic upper extremity in patients with~     stroke.~      Methods: A sample of 37 patients post stroke (29 males) was randomly assigned to either~     supervised physical therapy (SPT) control group (n=18) or supervised physical therapy and~     segmental muscle vibration (SPT-SMV) experimental group (n=19). All patients received 3~     sessions per week of SPT for 8 weeks. The SPT-SMV experimental group received SMV at the end~     of each SPT session. Outcome measures used were Barthel Index (BI), Modified Ashworth Scale~     (MAS), Manual Muscle Testing (MMT), and goniometry for Range of Motion (ROM) assessment.~   "
11232|NCT03419780|"~     There is a paucity of data on management of non-acute postpartum anemia. Although blood~     transfusions were historically initiated with 2 units, the most recent recommendation from~     the American Association of Blood Banks is to begin with 1 unit. As no randomized controlled~     trials have been performed in obstetrics, the investigators propose a randomized, controlled~     trial in non-acute postpartum anemia comparing single- versus multiple-unit transfusion by~     total numbers of units transfused and maternal morbidity.~   "
11233|NCT03419767|"~     The main purpose of this study is to study the phenomenon of insulin resistance in patients~     after carotid revascularization surgery through population-based, randomized, double-blind,~     placebo-controlled trial.~   "
11234|NCT03419754|"~     Prolonged sitting is a common behavior in contemporary humans. In epidemiological studies,~     increased sitting time has been associated with increased risk for cardiovascular disease and~     all-cause mortality. Recent research has also shown that interrupting sitting time with~     standing prevents the poorer glycemic control. However, studies are lacking which evaluate~     the impact of low intensity physical activity during prolonged sitting on vascular function.~     Whether low intensity physical activity can increase blood flow substantially and prevent~     impairment in vascular function and glycemic control is unknown.~      The purpose of the present study is to evaluate whether increased blood flow during sitting~     via low intensity physical activity (fidgetting) prevents the impairment in vascular function~     and poorer glycemic control associated with prolonged sitting.~   "
11254|NCT03419494|"~     This trial is a multicenter prospective, open, non-intervention clinical study. 200 patients~     with newly diagnosed adult ALL who underwent induction remission with the VDCLD regimen~     containing PLD and DNR, respectively,were plan to enrolled in this study to evaluate the CR~     rate and the level of myeloid leukemia stem cells in the first course of chemotherapy with~     two regimens; and to evaluate the safety of the two induction chemotherapy regimens.~   "
11343|NCT03418324|"~     This research study is being done to measure the clinical benefit of TRC105 in combination~     with abiraterone or enzalutamide in metastatic, castration-resistant prostate cancer patients~     who are taking either abiraterone or enzalutamide and showing signs of biochemical~     progression without radiographic progression. A patient who is progressing on AR-therapy will~     continue the same AR-therapy on study with the addition of TRC105. The two arms will accrue~     in parallel and independently.~   "
11235|NCT03419741|"~     Smoking cessation and relapse prevention represent and important opportunity to improve~     cancer survival rates, reduce the risk of cancer treatment complication, and improve the~     quality of life of patients with and survivors of cancer. Previous studies showed that~     repetitive TMS (rTMS) reduced cue craving to smoking and treat nicotine dependent smokers.~     Recently one study completed by our team demonstrated that 10 sessions of rTMS over the left~     dorsolateral prefrontal cortex (DLPFC) reduced cigarette consumption and cue craving, and~     also increased quitting rate on target quit date in nicotine dependent smokers. Thus, we~     propose conducting a controlled, double-blind trial comparing the effect of treatments of~     active rTMS and sham rTMS on cigarette abstinence days, cigarette consumption and smoking~     craving during a 7-days of quit attempt period in 20 nicotine-dependent patients with cancer.~     Specific aims are: Aim 1: Assess a feasibility of the rTMS for smoking cessation in cancer~     patients. Aim 2: Obtain preliminary estimates of whether one-week active rTMS of left DLPFC~     tends to be more efficacious than sham rTMS during a 7-days of quit attempt laboratory model~     period increasing abstinence days, and also decreasing cigarette consumption and cue-elicited~     craving in cancer patients with smoking.~   "
11236|NCT03419728|"~     Under contract to the U.S. Department of Health and Human Services (DHHS), Mathematica Policy~     Research is conducting an impact study of Healthy Families Healthy Futures in Houston, Texas~     for a Federal Evaluation of Programs for Expectant and Parenting Youth (PEPY). The impact~     study will be designed to address three main questions:~        -  Was the program successful in exposing participants to program content, such as~          information about methods of birth control?~        -  Was the program successful at improving short-term outcomes, such as use of a LARC and~          intention to space births?~        -  To what extent did treatment youth receive the intended program components?~   "
11237|NCT03419715|"~     The study is to assess the effectiveness of topically applied bimatoprost in reducing~     migraine headache frequency, severity, and duration. It will also assess the effect of~     topical bimatoprost on quality of life.~   "
11238|NCT03419702|"~     The primary objective of the proposed study is to examine and understand the impact of~     long-term almond consumption on chronic glucose metabolism in subjects with impaired glucose~     tolerance.~   "
11239|NCT03419689|"~     This is a sample study that will collect biological samples (blood, tumor tissue, ascites,~     and/or other fluids) from gynecological cancer patients for biomarker research. In addition,~     the results of the testing done on the samples will be given to the participant's treating~     physician who may use the information to guide treatment decisions.~   "
11240|NCT03419676|"~     The objective of this study is to determine the effect of the sealant patch Hemopatch,~     compared to current practice without any sealant, on the decrease of the postoperative~     pancreatic fistula on patients undergoing pancreatoduodenectomy for benign or malignant~     tumors or other benign process.~   "
11241|NCT03419663|"~     This project involved a systematic literature review of published trials of cereal or grain~     in relation to the risk of gastric cancer. Data was extracted from the publications on~     PubMed, EMBASE, Cochrane Library.A traditional meta-analysis, subgroup analysis, and~     heterogeneity was conducted on the extracted data.~   "
11242|NCT03419650|"~     Demonstrate the clinical value of Acthar TM in patients with active Psoriatic Arthritis who~     lack adequate response to DMARDS, and the quantification of response by clinical, serologic~     and structural parameters.~   "
11243|NCT03419637|"~     Part I of this study surveys patients in the Penn Dermatologic Surgery Clinic to evaluate if~     a need exists for increased patient understanding of their skin history and which factors, if~     any, related to the patient or their skin history are associated with this need. In part II,~     the study aim is to evaluate mobile technology as a way of improving patient understanding of~     diagnoses, treatments, and procedures. In this part of the study, eligible patients from part~     I will be randomized either to a control group that receives the current standard of care~     regarding in-clinic counseling, informational handouts, and access to their medical records,~     or to an intervention group that in addition to the current standard of care, is setup with a~     mobile app, allowing patients to view a skin history summary report and a reference on their~     skin ﬁndings and procedures. Patients then complete a survey to establish their baseline~     understanding of their clinic visit. Three weeks later the patient is emailed a follow-up~     survey to assess their understanding of their in-clinic visit. Differences in understanding~     between the two study groups will be assessed by comparing the number of correctly answered~     survey items regarding their in-clinic visit, both at baseline (immediately following their~     surgery) and three weeks later. Qualitative information regarding satisfaction and areas of~     improvement will also be collected via survey. Patients who have an appointment during the~     study period at the Penn Dermatologic Surgery clinic for a skin excision will be eligible for~     inclusion.~   "
11244|NCT03419624|"~     This is a 28-week, multi-center, randomized, double-blind, placebo-controlled trial to study~     a potential synergistic effect of Dapagliflozin plus Exenatide once-weekly in combination~     with high-dose intensive insulin therapy compared to Placebo in obese insulin-resistant~     patients with Type 2 Diabetes mellitus (T2DM) and inadequate glycemic control (HbA1c≥8.0% and~     ≤ 11.0%).~   "
11255|NCT03419481|"~     This is a single-arm Phase II trial of pembrolizumab in patients with hepatitis B~     virus-related hepatocellular carcinoma with parallel study on baseline and serial change in~     the immune environment.~      Subjects should have a confirmed diagnosis of HCC (in accordance with the AASLD guideline)~     and confirmed chronic infection with hepatitis B virus as defined by positivity for HBsAg.~     Antiviral therapy for HBV must be given for at least 12 weeks and HBV viral load must be less~     than 100 IU/mL prior to first dose of study drug. They must have disease not amenable to a~     curative treatment approach or loco-ablation. Subject must be fit and agreeable with baseline~     and post-treatment biopsy of tumor. Subjects must have at least one measurable lesion per~     Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, an Eastern Cooperative Oncology~     Group (ECOG) performance score of 0 or 1 and adequate organ functions. 30 subjects will be~     enrolled to receive pembrolizumab 200 mg IV every 3 weeks(Q3W). Pre-treatment and~     on-treatment biopsy after 2 cycles of Pembrolizumab will be preformed. Treatment will be~     stopped when progression of disease or intolerable toxicity occurs. The primary objectives of~     this trial are to study the efficacy and safety of pembrolizumab in patients with HBV-related~     HCC and to study the serial change in RNA expression of immune-related gene panel in~     post-treatment biopsy tissue.~      The secondary objectives of this trial are to study the serial change in cytokine profile~     between pre-treatment and post-treatment samples, to study the PD-L1 immunohistochemical~     (IHC) expression in tumor sample at baseline and post-treatment tissue samples and to study~     the presence of tumor infiltrating lymphocytes in the baseline and post-treatment tumor~     samples.~      The exploratory objective of this trial is to evaluate the possibility of using baseline and~     the serial change in RNA expression of immune-related gene panel or PD-L1/2 IHC to predict~     treatment response.~   "
18833|NCT03320421|"~     This phase II study is to evaluate the safety of hypofractionated whole breast radiation~     (HFRT) with simultaneous tumor bed boost(SIB) in women with early breast cancer after~     breast-conserving surgery.~   "
11245|NCT03419611|"~     Our project highlights one of the primary areas of research within the Kansas Intellectual~     and Developmental Research Center— language and communication. Specifically, we focus on~     language and communication in children with autism and minimal verbal skills (less than 20~     spoken words). Remaining nonverbal past the age of 5 years has been considered a poor~     prognostic indicator for future language developments (Picket et al., 2009), yet few~     interventions have been developed to address this problem. The Specific Aims for this project~     are (1) to further investigate a multimodal intervention for school-age children with minimal~     verbal skills—defined as less than 20 words spontaneously spoken, signed, or selected via~     graphic symbol selection—and (2) to identify significant covariates associated with~     differential responding to the intervention. The research addresses an unmet need to promote~     spoken word production in children who remain essentially nonverbal well past the ages~     associated with speech acquisition. The project is also innovative because: a) it~     investigates a multimodal intervention based on principles of phonotactic probability and~     neighborhood density in combination with augmentative and alternative communication (AAC),~     and b) it investigates novel predictors of treatment response that are obtained through~     cutting-edge technologies. We propose that this intervention will have better success than~     past interventions because we will provide increased input through speech, digitized speech~     and visual images and additional speech sound practice for words that are comprised of high~     frequency sounds in the child's repertoire. Extant speech sounds in each participant's~     repertoire will be identified using LENA™ digitized recordings. Vocabulary words will then be~     selected based on a child's speech sound repertoire and principles of word learning—words~     with high probability speech sound sequences will be selected and taught with either our~     multimodal intervention or a treatment as usual condition. Responses to these interventions~     will be evaluated using a Sequential Multiple Assignment Randomized Trials (SMART) design. We~     propose that different outcomes will be associated with individual and environmental~     predictors identified in our previous research. Individual predictors include verbal~     comprehension, imitation skills, adaptive behavior, nonverbal speech sound repertoire, and~     communication complexity. Communication complexity will be measured with the Communication~     Complexity Scale (CCS), developed by the Principal Investigator. Environmental predictors~     include language input to the child as measured with LENA™ recording devices. Results will~     determine if our multimodal intervention is more successful than treatment as usual for~     teaching word productions, but will also identify the individual and environmental profiles~     associated with differential outcomes. Our discoveries will lead to more focused clinical~     trial research and will inform customized intervention practices in schools and clinics.~     Ultimately this line of research aims to improve the lives of children with autism and their~     families through enhanced communication skills.~   "
11246|NCT03419598|"~     High Tibial Osteotomy (HTO) is an alternative to knee replacement in suitable patients with~     early knee osteoarthritis (OA), it is particularly suited to patients with single compart~     disease who otherwise would be suitable for unicompartmental knee replacement (UKR). OA of~     the knee is very common and increasing driven by the ageing of the population. The current~     limitations of HTO are related to the difficulty of achieving the desired correction due to a~     challenging surgical technique and soft tissue irritation due to the use of generic~     stabilisation plates. This study will examine the safety equivalence of a new patient~     specific HTO process which has patient specific 3D printed plates, ToKa, with the existing~     most commonly used HTO procedure using the Tomofix plate. Importantly this study will be~     undertaken as a Virtual Trial, existing anonymised 3D imaging data will be used to create the~     virtual patient cohort. This cohort will receive both procedures, which for this type of~     procedure is only possible in a virtual scenario.~      The main question to be addressed is: Is the ToKa procedure as safe as the most commonly~     used existing HTO procedure?. In this context safety concerns the mechanical loads placed~     upon the tibia and the support plate.~      The interventions will all be made on computer models, the 3D imaging data will be used to~     create the intact (un-operated) models of the subject tibias. Each model will then be~     virtually operated upon, with both the ToKa and Tomofix procedures. The models will then be~     loaded with physiological loads experienced during function and the mechanical states~     compared.~   "
11247|NCT03419585|"~     Fatigue due to cancer and its treatment (for example, radiation therapy) can interfere with~     quality of life and can linger long after treatment has ended, yet research examining~     preventative approaches has produced limited clinical benefit. The proposed study will~     provide information about systematic light exposure for the prevention of fatigue in prostate~     cancer patients undergoing radiation therapy and will investigate how it works. This study~     would facilitate the development of this potential preventative treatment, giving health care~     providers and cancer survivors a much-needed tool to help with cancer-related fatigue.~   "
11248|NCT03419572|"~     The objective of this study is to understand the utilization of cabozantinib in subjects with~     advanced renal cell carcinoma (RCC) following prior VEGF-targeted therapy in real life~     settings in terms of dose modifications due to adverse events (AEs) when used as a second~     line therapy or third and later line therapy. Other patterns of use of cabozantinib will also~     be described.~   "
11249|NCT03419559|"~     This study is a Phase 2, open-label, 2-cohort, multicenter study evaluating adoptive cell~     therapy (ACT) with autologous TIL therapy (LN-145) alone, (Cohort 1), or in combination with~     durvalumab (anti-programmed cell death ligand 1 [PD-L1] monoclonal antibody [mAb]) (Cohort~     2).~   "
11250|NCT03419546|"~     The aim of this study is to evaluate the usefulness of the new Ambu® aScope ™ 4 bronchoscope,~     in the usual practice of low complexity diagnostic bronchoscopy managed by bronchoscopists~     who meet the minimum training requirements (having performed 100 supervised procedures [ 10])~     and maintenance of competition (with more than 25 bronchoscopies per year [10]).~   "
11251|NCT03419533|"~     This is an observational cross sectional study to evaluate the impact of a 4CMenB vaccination~     program on oropharyngeal N. meningitidis carriage in vaccinated and unvaccinated school~     leavers.~   "
11252|NCT03419520|"~     Obesity is a multifactorial, complex, chronic disease of special concern. It is originated as~     an interaction between genetic predisposition and environmental factors. Thus, knowledge of~     gene-diet interactions is especially important. However, most studies analyzing the efficacy~     of diet on body weight have not considered the genetic variability among the population.~      Childhood and adolescence are critical periods in the development of obesity. This is~     because, on one hand, during infancy dietary patterns are being implemented. Moreover, it has~     been described that around the age of 6 it occurs the adiposity rebound, which consists in~     the increase in body mass index (BMI) that occurs after reaching a lowest point in infancy.~     It is believed that an early adiposity rebound is associated with a higher risk of developing~     obesity in the following years. The prevalence of overweight and obese children is increasing~     every year. Specifically, according to the World Health Organization (WHO) the number of~     overweight or obese children aged 0 to 5 years, increased from 32 million globally in 1990 to~     41 million in 2016. Regarding Spanish children, they are amongst the highest levels of~     overweight and obesity in Europe. Precisely, in 2015 the Spanish Agency for Consumer Affairs,~     Food Safety and Nutrition reported 23.2 % overweight and 18.1 % obese Spanish children,~     according to the ALADINO study.~      Considering the previous elaboration, we hypothesized that an early identification of SNPs~     associated with obesity will improve the strategies applied for its prevention. Moreover, an~     adequate nutritional counseling and a healthy lifestyle implementation during childhood will~     contribute to a higher quality of life in the adulthood.~      Thus, schools from the Madrid Community agreeing to participate in the study will be randomly~     assigned to either control or intervention groups. Then, an initial evaluation where 26 SNPs~     associated with obesity and its related comorbidities will be carried out in all children~     involved in the study, in addition to anthropometric, blood pressure measurements, and~     physical activity and dietary patterns evaluation. Then, each group will be divided in two~     according to the genetic risk (high vs low) for presenting obesity and its related~     comorbidities. The initial evaluation was performed on all children at 1st and 2nd grades and~     it is going to be followed by 3 monitoring actions in the following years where the~     progression of anthropometric measurements and dietary habits are going to be studied.~     Besides, the intervention schools are going to receive healthy actions along the study aimed~     to reduce the risk of developing obesity.~   "
11298|NCT03418922|"~     The primary objective of this study is to evaluate the tolerability and safety of a~     combination of lenvatinib plus nivolumab in participants with hepatocellular carcinoma (HCC).~   "
11256|NCT03419468|"~     The Self Geriatric Assessment Measure [SGAM] is based on a standard diagnostic tool used to~     evaluate geriatric cancer patients in order to determine the appropriateness of cancer~     directed therapy at LCI. This questionnaire has sections that matches portions of a~     self-administered geriatric assessment in patients aged 70 or older with malignancy. The~     prolonged duration of time needed to complete the assessment makes its performance less~     feasible in standard practice settings.~      In previously published studies the Cancer Specific Geriatric Assessment (CSGA) has been~     provided both via written questionnaire and by personal computer in subjects 70 years of age~     or older. With improvements in technology we seek to evaluate the feasibility of~     administering the SGAM via an iPad tablet and compare our results to both gold standard paper~     format and prior desktop computer data.~      This study proposes the use of an iPad tablet to administer the SGAM may help:~      Improve the completion rate of the SGAM assessment Reduction in the time of completion~     Improvement in the accuracy of reporting~   "
11257|NCT03419455|"~     Obesity is associated with increased risk of several cancers. Suggested mechanisms mediating~     the obesity-cancer associations include hyperinsulinemia and altered IGF signaling, changes~     in sex hormone levels as well as altered secretion of adipokines and inflammatory proteins.~     However, little is known about the influence of lifetime adiposity on the relevant~     biomarkers. Moreover, although diet has been suggested to ameliorate the adverse metabolic~     effects of obesity, convincing evidence regarding how dietary factors may influence~     obesity-related carcinogenic pathways remains lacking. Thus, in the current project, the~     investigators aim to 1) examine the associations between trajectories of body fatness and~     plasma biomarker levels of the insulin/IGF system, sex hormones and biomarkers of~     inflammatory response including adipokines; 2) investigate how nutritional factors may~     modulate these obesity-related biomarkers. The investigators propose to utilize two large~     ongoing cohorts of US men and women, the Nurses' Health Study and Health Professionals~     Follow-up Study.~   "
11258|NCT03419442|"~     The study will be conducted from a real-world perspective to describe treatment sequences~     involving radium-223 and chemotherapy in patients with metastatic castrate resistant prostate~     cancer (mCRPC) and assess overall survival (OS) associated with treatment sequences involving~     radium-223 and chemotherapy. While clinical trials of radium-223 has demonstrated a survival~     benefit in the treatment of mCRPC, both pre and post- docetaxel, study lacked exposure to~     second generation androgens and hence could not assess outcomes pre or post abiraterone or~     enzalutamide.~      The specific objective of this study is to describe and compare the clinical outcomes between~     treatment sequences for patients with mCRPC where 1) radium-223 is used (alone or in~     combination with abiraterone or enzalutamide) prior to chemotherapy versus 2) radium-223 used~     after chemotherapy in the treatment of mCRPC. The secondary objectives are to describe the~     safety patterns of docetaxel use among mCRPC patients who received chemotherapy post~     radium-223.~   "
11259|NCT03419429|"~     Modified perforated membrane (MPM) is considered as a modality that could enable~     participation of periosteal cells and gingival stem cells which could improve the outcomes of~     guided tissue regeneration more than the use of the traditional occlusive membrane (OM).~     Simvastatin (SMV) modulates bone formation by increasing the expression of bone morphogenetic~     protein 2 and angiogenesis. Ethylenediaminetetraacitic acid (EDTA) found to be effective as~     low ph etchant for smear layer removal and exposing root surface collagen. The investigators~     compared the clinical and radiographic outcome of SMV gel combined with MPM to SMV gel~     combined with OM with and without an associated EDTA gel root surface etching for improving~     bone regeneration in intrabony defects in chronic periodontitis patients. Moreover,~     evaluation of SMV gingival crevicular fluid (GCF) levels availability for 30 days in cases~     with and without EDTA root surface etching was performed.~   "
11260|NCT03419416|"~     The main objective is to implement Kangaroo Mother Care (KMC) at selected facilities in Addis~     Ababa and Oromia Regions to achieve high effective coverage in the catchment population.~   "
11261|NCT03419403|"~     This study will evaluate the effect of several ophthalmologic prophylactic treatment~     strategies for the management of ocular side effects (OSEs) in participants with epidermal~     growth factor receptor (EGFR)-amplified glioblastoma (GBM) who are being treated with~     depatuxizumab mafodotin (ABT-414). The study will include 2 phases during the treatment~     period: chemoradiation therapy (radiation plus temozolomide [RT/TMZ]) and adjuvant therapy~     (TMZ ). All participants will receive depatuxizumab mafodotin during both phases of the~     treatment period plus 1 of 3 prophylactic ophthalmologic treatments (standard steroids [SS],~     standard steroids with vasoconstrictors and cold compress [SS/VC], and enhanced steroids with~     vasoconstrictors and cooling compress [ES/VC]).~   "
11262|NCT03419390|"~     The novel Coaxial Optical Coherence Tomography (OCT) System is designed to visualize both~     structures of the retina and choroid.~      The purpose of this research is the safety and evaluation of a combined coaxial optical~     coherence tomography (OCT) system, to image diseases of the posterior and anterior segment of~     the eye.~   "
11263|NCT03419377|"~     A randomised controlled trial of Lichen Sclerosus in a period of six months measuring Quality~     of Life and sexuality among women with Lichen Sclerosus.~   "
11264|NCT03419364|"~     Phase II Study of 2.5 gm of nicotinamide, given daily in 3 divided doses, to measure effect~     on maternal blood pressure in women with early onset preeclampsia.~   "
11265|NCT03419351|"~     Self evaluating tools based on smartphone devices are public available on the market for each~     person. The tools are used to estimate the existing refractive error for each eye of a~     patient. Hereafter, e.g. ordering glasses via internet could be the next step for this~     persons.~      The daily routine within an eye hospital shows, that estimation of the refractive error is a~     difficult and time consuming procedure.~      The study compares the results of the measured refractive error using a smartphone based tool~     with the results of conventional measurement methods.~   "
11266|NCT03419338|"~     The aim of this study is to evaluate the efficacy of newly forming bone graft (NFB) in the~     gain of bone volume in sinus lift procedures. For that, it will be compared the tomographic~     bone gain 6 months after surgery between a group that received inorganic bovine bone alone~     (n=8) and a group that received inorganic bovine bone associated with NFB (n=8).~   "
11299|NCT03418909|"~     To investigate the treatment related effects of transoral robotic surgery (TORS) versus~     oncological treatment of oropharyngeal squamous cell carcinoma with a 1-year follow up.~   "
11267|NCT03419325|"~     Clopidogrel is a prescription medicine used to minimize blood clot formation in patients with~     cardiovascular disease, particularly those undergoing heart catheterization and stroke. A~     substantial amount of medical evidence has proven that patients with stroke or heart diseases~     can benefit from this medicine. However, significant variability in such expected benefits~     has been found among individuals receiving Clopidogrel, with some patients not having the~     benefit of reduced complications and adverse cardiovascular events. Prior studies have~     demonstrated a significant association between certain variants on patient's genes (e.g.,~     CYP2C19) and poor response to Clopidogrel and, therefore, major adverse cardiovascular~     events. Variation in other genes and other factors such as platelet activation, weight,~     diabetes mellitus (a medical condition that produces high blood sugar), concomitant use of~     other drugs and smoking status have also been proposed to be related with the same adverse~     outcomes. In this study the investigators would like to determine a possible association~     between these genes and the response to the medication among Caribbean Hispanic~     cardiovascular patients on Clopidogrel. In other population, it is known that patients with~     certain genetic variants have lower or magnified response to this medication when compared to~     those individuals taking the same dose and not carrying the genetic variations. However, a~     fundamental gap remains in understanding whether the genomic diversity of Caribbean Hispanics~     accounts for the observed high inter-individual variability of clinical outcomes to~     preventive dual antiplatelet therapy (DAPT) with Clopidogrel.~   "
11268|NCT03419312|"~     The primary aim of this study is to investigate cerebral mechanisms of burst stimulation in~     Failed Back Surgery Syndrome (FBSS) patients treated with Burst Spinal Cord Stimulation (SCS)~     for chronic back and leg pain. This study is a single center, prospective, blinded,~     randomized crossover trial with two 14 days treatment periods and two treatment arms (burst~     before sham stimulation or sham before burst stimulation).~   "
11269|NCT03419299|"~     Internal medicine resident physicians were provided an ipod with the EN application to assist~     them in choosing EN formulas for patients during their ICU rotation. The primary outcome was~     improved initiation of EN within 24 hours of admission. Secondary outcomes include, time to~     initiate EN, goal calories reached, infections rates, length of stay, mortality, and~     concordance with clinical guidelines.~   "
11270|NCT03419286|"~     The discovery of oncogenic mutations and the use of targeted therapies have transformed the~     management of certain tumors. Thus 12 to 15% of bronchial adenocarcinomas (AD) carry~     mutations of EGFR and receive from the first line inhibitors of this kinase (ITK). Despite~     spectacular results, relapse and resistance are quasi-general phenomena. In most known cases,~     EGFR-TKI resistance mechanisms involve secondary mutations of EGFR or the activation of~     alternative oncogenic pathways. However, in 5 to 15% of patients, resistance is manifested by~     the emergence of a small cell carcinoma (CPC), a cancer of neuroendocrine origin very~     different from AD by its cellular, molecular and epidemiological characteristics. This~     phenotypic transformation is an almost unique phenomenon in oncology and its molecular bases~     are not understood. To study this phenomenon, a Franco-Italian network was established that~     documented and collected cases of this rare tumor. This series is the subject of detailed~     anatomopathological, clinical and therapeutic documentation. This project aims to investigate~     the exome of one or more matched lesion regions to evaluate the evolutionary processes~     leading from the initial AD to the relapsing CPC. These results will guide future research on~     predictive markers of relapse and their targeted treatment.~   "
11271|NCT03419273|"~     A growing body of work done over the past few decades has established that adipose tissue as~     an active endocrine organ which secretes a wide range of metabolic and immunological factors~     collectively called adipokines (1). Importantly, these secreted factors enter into the~     circulation and have paracrine and autocrine actions, which profoundly impact systemic~     metabolism (e.g., insulin sensitivity). Additionally, in animals, loss of ovarian hormone~     production via ovariectomy (similar to menopause in humans) leads to increases in both in~     adipose tissue mass and in adipose tissue inflammation (2) making this tissue less healthy~     than that from premenopausal animals. To date, no studies have investigated the effect of~     menopause on abdominal fat in overweight individuals. Knowing if adipose tissue-specific~     changes occur with menopause may potentially lead to recommendations or therapeutics to~     improve women's health post menopause.~   "
11272|NCT03419260|"~     Electrographic seizures are common in critically ill patients leading to increased use of~     resource-intense continuous EEG monitoring for seizure identification and management. When~     identified, electrographic seizures are generally treated with anti-seizure medications, but~     there are very limited data available regarding optimal treatment in terms of the efficacy or~     safety of specific anti-seizure medications or overall management strategies.~      This is a single-center prospective observational study. The investigators aim to track~     critically ill patients undergoing clinically indicated EEG monitoring and seizure management~     to identify risk factors for electrographic seizures, create prediction models guiding EEG~     monitoring resources to the patients at highest risk for seizures, and evaluate our current~     management strategy in terms of safety.~   "
11273|NCT03419247|"~     This is a study where fresh tumor tissue and blood samples will be collected from patients~     with advanced biliary tract cancer who will be undergoing 1st line therapy with gemcitabine~     or fluorouracil (5-FU) regimens to see how useful it is to look for changes and~     characteristics in genes (molecules that contain instructions for the development and~     functioning of the cells) and the genes within the tumour to find characteristics that may be~     useful in choosing treatments for patients in the future.~   "
11274|NCT03419234|"~     This randomized phase II trial studies how well abiraterone acetate and antiandrogen therapy,~     with or without cabazitaxel and prednisone, work in treating patients with hormone-sensitive~     prostate cancer previously treated with docetaxel that has spread to other parts of the body.~     Androgens can cause the growth of prostate cancer cells. Hormone therapy using abiraterone~     acetate and antiandrogen therapy may fight prostate cancer by lowering and/or blocking the~     use of androgens by the tumor cells. Drugs used in chemotherapy, such as cabazitaxel and~     prednisone, work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Giving abiraterone~     acetate and antiandrogen therapy with or without cabazitaxel and prednisone may help kill~     more tumor cells.~   "
11275|NCT03419221|"~     S. aureus bloodstream infection (SAB) is a severe disease associated with a 30% case-fatality~     rate at 12 weeks. Severity of this disease is related to the high prevalence of~     staphylococcal Deep Foci of Infection (SA-DFI), which require prolonged duration of~     antimicrobial therapy and specific treatment. Timely diagnosis and management of SA-DFI is~     associated with an improvement of prognosis during SAB. 18 FDG PET/CT (PET/CT) is a useful~     tool in the diagnosis of infectious foci during bacterial infections.~      An ecological study performed in the Netherlands has shown that use of PET/CT in patients~     with Gram positive cocci bloodstream infection was associated with an increase of detection~     of DFI and a decrease of recurrences and mortality compared to historical controls.~      The investigators hypothesize that SAB poor prognosis is in part related to the lack of~     diagnosis of all infectious foci and consequently to a suboptimal treatment.~   "
11276|NCT03419208|"~     The Scleroderma Patient-centered Intervention Network (SPIN) is an organization established~     by researchers, health care providers, and people living with scleroderma (systemic sclerosis~     or SSc) from Canada, the USA, and Europe. The objectives of SPIN are (1) to assemble a large~     cohort of SSc patients to complete outcome assessments regularly in order to learn more about~     important problems faced by people living with SSc and (2) to develop and test a series of~     internet-based interventions to help patients manage aspects of their disease, including hand~     limitations.~      In SSc, approximately 90% of patients experience significant hand function limitations, which~     impact overall disability more than any other aspect of the disease. The SPIN hand exercise~     program was designed by SPIN experts in rehabilitation, behavioural therapies, and e-health~     interventions, as well as patient representatives in SPIN. The program core consists of 4~     modules that address specific aspects of hand function, and integrates tools to support key~     components of successful self-management programs, including goal-setting and feedback,~     social modeling, and mastery experiences.~      The SPIN-HAND trial is a pragmatic randomized control trial (RCT) embedded in the SPIN Cohort~     that will evaluate the effect of SPIN's online hand exercise program, in addition to usual~     care, on hand function and health related quality of life (HRQL) in SSc patients with at~     least mild hand function limitations. SPIN will randomize 586 SPIN Cohort participants with~     at least mild hand function limitations and an indicated interest in using an online hand~     exercise program to be offered the hand exercise program or usual care only.~   "
11277|NCT03419195|"~     This study will define the relationship of cardiac, vascular function and skeletal muscle~     blood flow (individually and together) to cardiovascular exercise capacity in in men and~     women with and without type 2 diabetes (T2DM). Identification of differences in the effects~     of exercise training on the integrated cardiovascular system and metabolism in men and women~     with and without T2DM will reveal specific adaptive responses to exercise.This study will~     evaluate & compare exercise function in a total of 60 subjects from the Denver area (30~     people with T2DM and 30 overweight control subjects).~      Specific Aim 1: To test the hypothesis that the integration of cardiac function,~     macrovascular function, and microvascular function is impaired in T2D and correlates with~     cardiovascular exercise capacity (CVEC) impairment.~      Specific Aim 2: To test the hypothesis that exercise training will elicit adaptive responses~     in cardiac and vascular function, muscle perfusion and metabolism with differences by T2D~     status.~      Differences between the exercise responses in people with T2DM and healthy people will help~     further identify the disease process of T2DM and direct future research of treatments and~     interventions.~   "
11278|NCT03419182|"~     There is debate over the best management for acetabular (hip) fractures that occur within the~     geriatric population. Geriatric patients, 60 years or older, are at greater risk for~     operative complications because they tend to have poorer bone quality, complicated fractures,~     and multiple health problems. Physicians currently have no guidelines as to the best surgical~     management for these particular fractures, because there is little data on the long-term~     outcomes of these injuries. The use of internal fixation (a nail or plate) is a standard~     method for repairing these injuries, however when the injuries are complicated it is~     predicted to have a poorer outcome than performing internal fixation along with total hip~     arthroplasty (joint reconstruction). Given the significant problems that result from hip~     fractures in this population, our study is designed to determine the best method for~     treatment of acetabular fractures and to clarify the criteria for treatment with guidelines~     assisting the physician in selecting the appropriate treatment.~   "
11279|NCT03419169|"~     This study is examining the post-operative rehabilitation of anterior cruciate ligament (ACL)~     reconstruction patients within the National Health Service (NHS). It will compare the~     effectiveness of two resistance training protocols, light load blood flow restriction (BFR)~     training and heavy load training, on improving multiple aspects important to the~     rehabilitation process in this patient demographic, whilst also examining the feasibility of~     this novel training modality. It is hypothesised that light load BFR training will be equally~     effective as heavy load training, but more tolerable for patients.~   "
11280|NCT03419156|"~     The investigators will be using a text messaging intervention to identify potentially~     dangerous and re- admission causing symptoms in patients with Short Bowel Syndrome (SBS) on~     Total Parenteral Nutrition (TPN). Each consented patient will receive weekly text messages~     inquiring about potentially harmful symptoms identified by a team of physicians. If the~     patient screens positive via text message, an alert will be sent to the medical team. All~     patients with SBS on TPN will receive text messages. The investigators will be monitoring~     response rates to text messages screening for potentially harmful symptoms and compare the~     text- message response rate to historical rates of successful calls by nurses.~      All patients with SBS on TPN will receive text messages instead of weekly phone calls from a~     nurse. If the patient does not respond to the text messages or the text message responses~     suggest that the patient may be presenting with potentially harmful symptoms, the nurse will~     call the patient to inquire about more information.~   "
11281|NCT03419143|"~     This is a long-term, observational study of Abatacept in patients with Psoriatic Arthritis, a~     chronic inflammatory disorder.~   "
11282|NCT03419130|"~     This randomized phase II trial studies how well radiation therapy and pembrolizumab work in~     treating patients with urothelial bladder cancer that is restricted to the site of origin,~     without evidence of spread. Radiation therapy uses high energy x-rays to kill tumor cells and~     shrink tumors. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability~     of tumor cells to grow and spread. Giving radiation therapy and pembrolizumab may work better~     in treating urothelial bladder cancer.~   "
11283|NCT03419117|"~     The erector spinae plane (ESP) block is a novel regional anesthetic technique for the~     treatment of thoracic, cervical, and abdominal pain. This pilot study aims to investigate the~     post-operative analgesic effectiveness of ultrasound guided single-shot ESP blocks for~     patients undergoing minimally invasive thoracoscopic wedge resections of the lung in~     comparison to those receiving conventional parental opioid analgesia alone. This will be~     achieved through the use of objective measures including quality the 40 point Quality of~     Recovery assessment (QoR-40) on postoperative day (POD) 1, visual-analogue pain scale (VAS)~     in the post-anesthetic care unit (PACU) and at POD 1, and oral morphine-equivalent (OME)~     opioid consumption in the PACU and at 24 hours post-operatively.~   "
11284|NCT03419104|"~     The aim of our study is to evaluate the efficacy of 60 meters 60 seconds exercise test (a~     test designed by the study group) done preoperatively as a predictor test for postoperative~     intensive care unit need and extubation success in patients undergoing bariatric surgery.~   "
11285|NCT03419091|"~     Most flexible ureteroscopes that are used to treat kidney stones have been reusable.~     Recently, advances in technology have resulted in single-use (disposable) ureteroscopes to~     become available. The investigators are interested in determining if the performance of the~     two types of scopes are equivalent. This will help guide institutions in the future to~     purchase the best scopes for their patients.~   "
11286|NCT03419078|"~     Retrospective case-note review to determine if nutrition via the enteral compared to the~     parenteral route results in better outcomes after haematopoietic cell transplantation.~   "
11287|NCT03419065|"~     The purpose of this study is to investigate the effects of participation in relaxation~     exercises on pregnant women who are hospitalized on bed-rest.~   "
11288|NCT03419052|"~     The purpose of this study is to learn how foods high in polyphenols and brain training~     exercises affect older adults' cognitive performance~   "
11289|NCT03419039|"~     The aim of this project is to study the safety and efficacy of anthocyanins in improving key~     dementia-related mechanisms and cognitive functioning in older people at risk for dementia.~     Secondary analyses will include a variety of biological measures, including biochemistry,~     imaging and cardiovascular measures.~   "
11290|NCT03419026|"~     Breast cancer, the first female cancer, affects one in eight women in her lifetime. The~     increase and uneven distribution of its prevalence throughout the world cannot be fully~     explained either by the increase in life expectancy, or by genetic factors present in less~     than 10% of cases, or by early detection, or by the use of hormone therapy for menopause at~     certain periods of time.~      Numerous experimental and epidemiological arguments, as well as the increased risk of breast~     cancer in women after 50 years of age who were exposed in utero to Distilbene prescribed for~     their mothers in the 1950s to 75's, suggest the involvement of environmental factors involved~     in early development (nutrition, alcohol, tobacco, chemical pollutants) that may act as~     endocrine disruptors, estrogenomimetic or intervening on other nuclear receptors such as the~     However, the formal demonstration of the deleterious physiopathological role of such exposure~     comes up against methodological difficulties in epidemiological terms: first of all, the fact~     that correlation is sought at the time of the discovery of breast cancer when there are~     critical windows of exposure (fetal, perinatal, peripubertal and pregnant) and that~     persistent organic products or POPs, most often lipids, are present.~      The objective of this project is to correlate the per-gravidic exposure to POPs (dioxins,~     dioxinlike, polychlorinated bisphenyls, organochlorine pesticides and flame-retardant~     polybrominated derivatives) and the development, within 15 years of delivery, of breast~     cancer, taking into account the confounding factors of classical breast cancer risk (age,~     reproductive events, etc.).~      This project benefits on the one hand from a cord blood bank set up between 2002 and 2005~     (6,242 samples) carried out at the Nice University Hospital and the Grasse University~     Hospital, during a PHRC and on the other hand from the cancer observatory / CRISAP of the~     PACA Corsica region, exhaustive to more than 92% since 2005, registers which will be~     cross-referenced and whose cancer cases (N) will be compared to controls. The assays will be~     carried out after purification, using high-resolution mass spectrometry gas chromatography~     coupling, the quantification being carried out according to the principle of isotopic~     dilution. They will be carried out by LABERCA in Nantes, the national reference laboratory of~     the French Health Agencies ANSES and INVS and also involved in various European projects.~     Concentrations related to blood lipids will be expressed in quartile and analyzed separately~     or combined with a cumulative score taking into account confounding risk factors for breast~     cancer and the geolocation of the initial and final residence in relation to the incinerator~     of the City of Nice (Department of Public Health CHU of Nice).~   "
11291|NCT03419013|"~     This study investigated the performance of a new adhesive strip when impacted by output~   "
11292|NCT03419000|"~     Sudden and unexpected death in epilepsy (SUDEP) has become a major issue for patients with~     epilepsy and their physicians. SUDEP is a nontraumatic and non-drowning death in patients~     with epilepsy, unrelated to a documented status epilepticus, in which postmortem examination~     does not reveal a toxicologic or anatomic cause of death. It primarily affects young adults~     with drug-resistant epilepsy, with an incidence of about 0.5%/year. A recent study reported~     that up to 20% of patients with childhood onset drug resistant epilepsy will die of a SUDEP~     by the age of 45. Apart from optimizing antiepileptic drugs, no preventive treatment is~     available to prevent SUDEP. As underscored by the World Health Organization (WHO), there is~     an urgent need to develop specific therapeutic approaches to tackle this issue.~      The primary objective of the proposal is to evaluate the diagnostic value of a set of~     circulating microRNAs pre-selected because of their implication in the regulation of~     molecular pathways involved in the respiratory regulation to identify patients with~     seizure-related respiratory dysfunction, as defined by occurrence ictal/peri-ictal pulse~     oxymetry < 90%.~      A total of 50 patients will be included over a period of one year. Patients undergoing~     long-term video-EEG/SEEG monitoring will be recruited in the epilepsy monitoring unit of the~     Department of Functional Neurology and Epileptology, Hospices Civils de Lyon, Lyon, France.~      It will be a case-control study in a cohort of patients with drug-resistant focal epilepsy~     undergoing long-term video-EEG monitoring, in which patients who demonstrate ictal/post-ictal~     hypoxemia (cases) will be compared with those without seizure-related respiratory dysfunction~     (controls).~   "
11293|NCT03418987|"~     The diagnosis and classification of scoliosis are almost exclusively based on frontal and~     lateral radiographs. Current classifications of adolescent or adult idiopathic degenerative~     scoliosis are based only on the 2D approach. The classifications consider only the lateral~     deviation and the sagittal alignment and completely ignore all the changes (the axial~     vertebral rotation and the lateral translation etc ...) in the horizontal plane.~      The demand for an accurate assessment of the vertebral rotation in scoliosis is not new.~     Biplane x-ray images provide insufficient quantitative or qualitative information on the~     anatomical landmarks needed to determine axial rotation. Several measurement methods have~     been published, all of which are based on the evaluation of the relative positions of various~     posterior vertebral elements. The Perdriolle torsiometer is currently the most accepted~     method in clinical practice, but its reproducibility is very limited and can not be~     quantified accurately.The horizontal plane deviations are more accurately evaluated by the CT~     scan, but the systematic use of this method is limited because of its relatively high cost~     and excessive radiation dose. Expert opinion is also divided on the veracity and~     reproducibility of CT scan for such measurements.~      Given the absence of a definitive and reproducible measurement method for 3D characterization~     of the vertebral columnar deformities, the investigators introduced the concept and system of~     vertebral vectors.The vertebral vector technique is currently the only technique in the world~     that allows the visualization of vertebral column deformities by analyzing each vertebral~     body and defining characteristic mathematical and geometric parameters that uniquely~     characterize each vertebrae. A new digital radioimaging technique based on a low dose X-ray~     detection technology simultaneously creates frontal and lateral whole body radiographic~     images captured in a standing position, which is the basis of visualization of the vertebral~     vector.~      To examine the two phenotypes of scoliosis, it is necessary to collect the radiological data~     specific to the disease. After generating the vertebral vectors and obtaining the~     three-dimensional coordinates, an analysis and an exact mathematical description will be~     performed. The projections of the curves in the three planes will also be analyzed, with~     particular attention to the projections in the horizontal planes. Based on the mathematical~     models and the axial projection of the curves, a new three-dimensional classification can be~     imagined for the first time not only for adolescent scoliosis, but also for adult~     degenerative scoliosis.~      The main objective of this study is to develop new evidence-based treatments based on the~     unambiguous understanding of 3D features of vertebral columnar deformities.~   "
11294|NCT03418974|"~     This study is designed to verify the clinical efficacy and safety of different statins in~     dyslipidemia patients, and explore the effects on glycometabolic in patients with impaired~     glucose regulation.~   "
11295|NCT03418961|"~     This phase III trial studies how well carvedilol works in preventing cardiac toxicity in~     patients with human epidermal growth factor receptor (HER)-2-positive breast cancer that has~     spread to other places in the body. A beta-blocker, such as carvedilol, is used to treat~     heart failure and high blood pressure, and it may prevent the heart from side effects of~     chemotherapy.~   "
11296|NCT03418948|"~     The aim of this international multicenter study is to compare the adenoma detection rate and~     adenoma miss rate of conventional and Endocuff Vision-assisted colonoscopy.~   "
11297|NCT03418935|"~     The purpose of this study is to assess the safety and efficacy of Remaxol (succinate +~     methionine + inosine + nicotinamide; POLYSAN Ltd., Russia) infusions at dose 400 and 800 ml~     to treat mechanical jaundice of non-tumor cause during the first week after surgery.~   "
11300|NCT03418896|"~     A pilot study showed that serum calcium levels and calcium homeostasis change in response to~     hCG stimulation test. Serum calcium level differed when comparing pretreatment values at~     baseline with serum levels 72 hours after hCG stimulation in men with gonadal insufficiency~     referred for this stimulation test. Now we want to investigate whether this change in calcium~     is due to renal loss or other mechanisms and how the classical regulators of calcium~     homeostasis respond to hCG in men with impaired gonadal function compared with men having~     normal gonadal function. Moreover, the observed change in serum calcium implies that hCG also~     changes Phosphate, PTH and calcitonin and this will be clarified with this study~   "
11301|NCT03418883|"~     This study evaluates the effects of mirror therapy on upper-limb motor impairment in stroke~     patients early after their cerebrovascular accident. In recent years mirror therapy has been~     used in stroke rehabilitation, both to ease motor (e.g., upper limb impairment) and cognitive~     (e.g., spatial neglect) recovery. To note, mirror therapy is a simple and inexpensive~     treatment that patients can practice independently and with no significant side effects.~     However, a recent review concluded that the currently evidence available is not enough to~     determine about the actual effectiveness of mirror therapy in stroke survivors. Moreover, at~     our knowledge, the majority of studies recruited chronic stroke patients while only a few~     trials recruited patients within few weeks after stroke. Therefore, further research is~     encouraged particularly early after stroke.~      In mirror therapy patients exercise their sound hand while it is reflected by a mirror placed~     at right angle to the patient's trunk. With this gambit, patients see two hands moving: their~     sound hand (i.e., the hand that is voluntarily moved) and the avatar of their impaired hand~     (i.e., the sound hand reflection in the mirror). In this assessor-blinded, randomized~     controlled trial half of participants receive mirror therapy .The other half receive sham~     therapy, in which the mirror is flipped so that the opaque surface face the sound arm. Mirror~     therapy and sham therapy are added to conventional rehabilitation.~      In the current work, we investigate the efficacy of mirror therapy on upper-limb recovery in~     early post-stroke patients.~   "
11302|NCT03418870|"~     The purpose of this study is to compare the standard of care in the neonatal intensive care~     unit (NICU), known as Family Centered Care, to a new model of care, called mobile enhanced~     Family Integrated Care. This exploratory two-group comparison study will examine the~     feasibility, acceptability and effectiveness, providing the first United States (US)~     information about outcomes of a new NICU care model that better integrates parents into all~     aspects of their baby's care. The use of mobile technology as part of this new model of care~     could improve access and equity in family integration for the many US families who face~     barriers to NICU involvement.~   "
11303|NCT03418857|"~     This study evaluates the effects of probiotic consumption on inflammatory outcomes and~     measures of gut health. Participants will be given yogurt with probiotics for one period and~     yogurt without probiotics for another, with a break in between. These periods will occur in~     random order.~   "
11304|NCT03418844|"~     While they are documented in patients in remission of testicular cancer, the sequelae of~     chemotherapy and the impact of the disease and its treatments on the living conditions and~     QoL of women in remission of rare ovarian cancer remain poorly explored.~      The coordinator therefore propose a national 2-step case-control study to evaluate 1) chronic~     fatigue and QoL and 2) chemotherapy-related sequelae in adult patients in remission of~     surgery-treated TGMO or TSCS (conservative or not) supplemented with chemotherapy~   "
11305|NCT03418831|"~     The aim of the project is to assess the efficacy of Adjunctive Selective Estrogen Receptor~     Modulators (Raloxifene) on Negative and Cognitive symptoms of Schizophrenia in Postmenopausal~     Women.~      For postmenopausal women with schizophrenia, current research suggests that these people can~     be treated with estrogen, which can reduce cardiovascular and reproductive tissue problems,~     help sleep and improve mood. In addition, cognitive problems in this group of people can also~     be helped. Raloxifene is a Selective Estrogen Receptor Modulator (SERM), which means that it~     can affect the central nervous system (CNS) effects of estrogen (eg. improving emotional~     symptoms, memory, information processing and concentration), without adversely affecting~     reproductive tissue/organs such as breast, uterus and ovaries. The investigators are~     conducting a double-blind, placebo controlled, 12 weeks study comparing the negative symptoms~     and cognitive functions in postmenopausal women with schizophrenia in both groups. One group~     will receive clozapine plus 60mg Raloxifene (Usage: take 60mg Raloxifene tablets half an hour~     after breakfast every day, that is, take 1 tablet a day), while the second group will receive~     clozapine plus oral placebo (Usage: take 1 placebo half an hour after breakfast every day).~      Hypothesis 1: Adjuvant raloxifene therapy in postmenopausal women with schizophrenia can~     improve negative symptoms, as measured on the rating scales, compared with the women~     receiving adjunctive placebo.~      Hypothesis 2: The cognitive function of postmenopausal female schizophrenic patients treated~     with raloxifene would be better than that of the placebo group.~      Hypothesis 3: That the Raloxifene group has less adverse reactions in postmenopausal women~     with schizophrenia.~   "
11306|NCT03418818|"~     This is a single arm, single centre, investigator initiated study to investigate the use of~     FAZA-PET in combination with MRI. FAZA is an investigational radiotracer used in PET scans.~     FAZA PET/MRI will be used to measure hypoxia in sarcoma tissues of 14 patients who plan to~     undergo neoadjuvant radiation/chemotherapy treatment.~      After the FAZA PET/MRI scan, patients will be followed up via telephone, 48 hours after the~     scan, to see if there are any side effects due to FAZA. Patients may also be requested to~     repeat the FAZA scan after their standard of care radiation treatment.~   "
11307|NCT03418805|"~     To evaluate the food effect of Ibuprofen CR Tablets 600 mg (IBUCR), and its bioavailability~     comparison versus 3 doses of the reference arms including Advil® Ibuprofen Tablets 200 mg~     (IBUAdv) and Motrin® IB Ibuprofen Tablets 200 mg (IBUMot) in normal healthy volunteers.~   "
11334|NCT03418441|"~     The Danish Study Group of Infections of the Brain is a collaboration between all departments~     of infectious diseases in Denmark. The investigators aim to monitor epidemiological trends in~     central nervous system (CNS) infections by a prospective registration of clinical~     characteristics and outcome of all adult (>17 years of age) patients with community-acquired~     CNS infections diagnosed and/or treated at departments of infectious diseases in Denmark~     since 1st of January 2015.~   "
41092|NCT03028870|"~     The purpose of this study is to evaluate the analgesic efficacy of V120083 twice daily~     compared to placebo in subjects with moderate to severe chronic pain due to OA of the knee.~   "
11308|NCT03418792|"~     The proposed study is an attempt to improve patient xerostomia (dry mouth) after definitive~     radiation therapy treatment for head and neck cancer. Xerostomia is a frequently experienced~     symptom for those receiving radiation therapies to the head and neck that persists after~     treatment, potentially indefinitely. It has been shown that stem/progenitor cells~     preferentially reside in large ducts of salivary glands and that these cells have the ability~     to repair radiation induced salivary damage. Current practice does not specifically attempt~     to spare these regions and considers the entire salivary gland to have equal importance and~     function. This study will involve the acquisition of pre-treatment MRI sialogram images which~     enable visualization of salivary ducts (using saliva itself as a contrast agent) that can~     then be avoided during radiation treatment planning. The primary objective will be to obtain~     patient reported outcomes (PRO) measure of xerostomia related symptoms for comparison with a~     historical cohort. Xerostomia symptom information will be obtained by use of a patient~     reported quality of life survey administered prior to treatment, six months after treatment,~     and one year after treatment. The secondary objectives will be to quantitatively assess~     post-treatment changes in salivary gland volume as well as ductal visibility using MRI~     sialograms. The study team hopes to acquire pre- and post-treatment images from 40 patients.~     The investigator hypothesizes that reducing the dose to these stem cell containing salivary~     ducts will facilitate improvements in patient reported symptoms as well as improved recovery~     of salivary gland volume and intra-glandular ductal visibility using MRI sialograms.~   "
11309|NCT03418779|"~     This study is a prospective open-label randomized controlled clinical trial with a two-group~     parallel design aiming to prove the Yi-Qi-Qing-Jie formula combined immunosuppressive agents~     brings less adverse events but more potential renal benefit than only immunosuppressive~     monotherapy for the treatment in high-risk IgAN patients.~   "
11310|NCT03418766|"~     The purpose of the study is to evaluate the prevalence of white matter lesions in Chinese~     migraineurs with and without right-to-left shunt. The aim is to study the relationship among~     right-to-left shunt, migraine and white matter lesions.~   "
11311|NCT03418753|"~     The study is a prospective, multi-center, non-randomized, open label observational study. The~     objective of this study is to compare the accuracy of the EyeBOX to a clinical diagnosis of~     abnormal ICP as determined by an external ventriculostomy drain (EVD) or ventriculostomy~     catheter.~   "
11312|NCT03418740|"~     The purpose of this study is to identify ways to follow progression of Friedreich's Ataxia~     (FA) and be able to measure changes over time in children with FA. Participants will have~     biannual visits to observe how the disease progresses over time and determine the rate of~     progression.~   "
11313|NCT03418727|"~     To evaluate the tolerability and preliminary efficacy of Brimonidine eye drops (with and~     without corticosteroid eye drops) for the treatment of Dry Eye Disease (DED).~   "
11314|NCT03418714|"~     This study will investigate the effects of salvinorin A on human brain activity and~     connectivity using functional magnetic resonance imaging (fMRI) methods. An inhalation route~     of administration will be used as it is the most common route for contemporary use of Salvia~     divinorum, a plant containing salvinorin A.~   "
11315|NCT03418701|"~     The study will test the effectiveness of a culturally sensitive, evidence-based,~     multi-component, behavioral program for treating obesity called Health-Smart. This program is~     being implemented by Community Health Workers at the primary care centers and followed by~     either of two physician-implemented behavioral counseling programs to prevent weight~     gain--programs that are implemented quarterly over 12 months.~   "
11316|NCT03418688|"~     The study is a randomized, double-blind, placebo-controlled, multiple ascending dose study to~     assess the safety and tolerability of ascending repeat doses of COR388 HCl in older healthy~     male and female subjects and a cohort of Alzheimer's disease subjects.~   "
11317|NCT03418675|"~     The primary objective of the proposed study is to evaluate the safety and efficacy of~     Brexpiprazole in adults with borderline personality disorder (BPD). The hypothesis to be~     tested is that brexpiprazole will be more effective and well tolerated in adults with BPD~     compared to placebo. The proposed study will provide needed data on the treatment of a~     disabling disorder.~   "
11318|NCT03418662|"~     The study aims to compare the results between a standard colonoscopy to a colonoscopy with an~     attachment on the distal end of the colonoscope.~   "
11319|NCT03418649|"~     Low back pain is a leading cause of disability and health care costs in the United States,~     and treatments are ineffective for many patients. Epidural steroid injections are a common~     treatment, but their efficacy has been questioned and for many patients they do not provide~     complete relief. The investigators hypothesize, based on preclinical studies, that lack of~     complete efficacy may be due to the fact that clinically used steroids activate not only the~     intended drug target, the glucocorticoid receptor, but also the pro-inflammatory~     mineralocorticoid receptor. To test this hypothesis, this pilot study will recruit patients~     scheduled for lumbar epidural steroid injections for degenerative disc disease, and randomize~     them to receive a concurrent treatment with oral eplerenone (a clinically approved antagonist~     of the mineralocorticoid receptor) or placebo for 10 days starting just after the epidural~     injection. At several time points during the following year, subjects will answer the~     Oswestry Low Back Pain Questionnaire, to report on both pain and functional outcomes.~   "
11320|NCT03418636|"~     The growing population of young people who inject drugs (PWID) is at extremely high risk for~     HCV infection through the use of contaminated injection equipment, yet, to date, no~     behavioral intervention has been sufficiently potent to produce significant reductions in HCV~     incidence among PWID. To address this critical public health need, our team developed Staying~     Safe (Ssafe), an innovative, strengths-based, socio-behavioral HCV prevention intervention~     found in preliminary research to be highly acceptable and feasible, with strong indications~     of efficacy. The proposed randomized, controlled trial will assess the effectiveness of the~     Ssafe intervention in reducing both injection-related HCV/HIV risk behavior and HCV incidence~     among young adults (ages 18-29) who inject opioids (heroin and/or prescription opioids).~   "
11407|NCT03417479|"~     This double blind randomized control trial will enroll 100 participants ages 12-18 years,~     undergoing ACL repair. Participants receive gabapentin or placebo preoperatively. Outcome~     measurements of self-reported pain score using scale of 1 to 10 with 10 being the worse~     obtained from the EMR and participants interviews with a phone nurse for five days~     postoperatively to determine severity of pain as well as use of opioids.~   "
11321|NCT03418623|"~     This study is aimed at examining whether GET73 modulates the indices of central glutamate and~     γ-aminobutyric acid (GABA) levels in recently abstinent subjects that meet Alcohol Use~     Disorder (AUD) criteria, as measured by proton nuclear magnetic resonance spectroscopy~     (¹H-MRS), in order to provide a human translation of the findings demonstrated in different~     preclinical models, both in vitro and in vivo. In addition, the study will examine the~     effects of GET73 on alcohol cue induced brain activation by using a well-established~     blood-oxygen-level-dependent (BOLD) functional magnetic resonance (fMRI) paradigm in the same~     individuals. In summary, the study should provide important information on (i) the potential~     mechanism of action of GET73, (ii) on the brain mechanisms that would support its potential~     use for reduction in craving and drinking in AUD patients, and (iii) expand data on its safe~     use as a medication in heavy drinking individuals.~   "
11322|NCT03418610|"~     This research study is being performed to evaluate the photographic evidence of the efficacy~     and tolerability of Azelaic Acid Foam 15% in the treatment of papulopustular rosacea.~   "
11323|NCT03418597|"~     The primary objective of this trial is to evaluate the benefit of the virtual reality~     technology in the pain management for patients having a radio-guided musculoskeletal biopsy~     indication~   "
11324|NCT03418584|"~     The purpose of this study is to evaluate the efficacy and safety of the new technique of~     HybridAPC in the treatment of Barrett.~   "
11325|NCT03418571|"~     The objectives of this study are:~        -  to evaluate the safety, tolerability, and systemic pharmacokinetics (PK) of different~          doses of inhaled ALX-0171 in Japanese infants and young children hospitalized for~          respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI).~        -  to evaluate the antiviral effect, clinical activity, immunogenicity, and~          pharmacodynamics (PD) of different doses of inhaled ALX-0171 in Japanese infants and~          young children hospitalized for RSV LRTI.~   "
11326|NCT03418558|"~     This is a phase II, open label, multicenter study. Patients with advanced colon rectal cancer~     (CRC) harboring an amplified HER2 that have been previously treated and progressed with an~     aNti-HER2 treatment, will be treated with the anti HER2 antibody conjugate trastuzumab~     emtansine (TDM1).~      Patients will receive study medication until disease progression, unacceptable toxicity,~     withdrawal of consent or death. Main objective of the study is the evaluation of objective~     response rate according to RECIST 1.1 criteria. Disease control rate, defined as the sum of~     complete, partial and stable disease patients over total patient, followed by response~     duration, time to progression and safety are secondary endpoints.~   "
11327|NCT03418532|"~     The purpose of this study is to assess the anti-tumor efficacy, safety, tolerability,~     pharmacokinetics (PK), immunogenicity and biological activity of the MP0250 DARPin® drug~     candidate in combination with osimertinib orally once daily (o.d.), when administered to~     patients with EGFR mutated, advanced, non squamous NSCLC after tumor progression on~     osimertinib and on or after the most recent therapy.~      MP0250 is a multi-DARPin® protein with three specificities, able to simultaneously neutralize~     the activities of vascular endothelial growth factor (VEGF) and hepatocyte growth factor~     (HGF) and also to bind to human serum albumin (HSA) to give an increased plasma half-life and~     potentially enhanced tumor penetration.~   "
11328|NCT03418519|"~     This study evaluates CIMT(Constraint Induced Movement Therapy) in the treatment of physical~     activity performance and motor function of the weaker extremity in young children with~     cerebral palsy. Half of participants will receive CIMT while the other half will receive no~     treatment.~   "
11329|NCT03418506|"~     Oral cancer is a serious and growing problem in many parts of the globe. Oral cancer is the~     eighth most common cancer worldwide.The annual estimated incidence is around 275,000 for oral~     and 130,300 for pharyngeal cancers excluding nasopharynx, two-thirds of these cases occurring~     in developing countries. In Pakistan, it is the second most common cancer in women and third~     most common cancer in men. The Age Standardized Rates (ASR) for oral cancers are 13.8 and~     14.1 in males and females respectively.To the best of investigators knowledge, no~     intervention study has been done to improve knowledge and awareness of adults regarding~     association of areca nut/betel quid with oral cancer. Therefore, the study aims to implement~     a cluster randomized intervention trial in secondary schools to improve the knowledge and~     awareness regarding this association among children 11-16 years. For resource poor countries~     such as Pakistan, it is imperative to prevent oral cancer by improving knowledge about its~     important risk factor such as betel quid, areca nut and chew tobacco. A school-based~     intervention study will be carried out in secondary schools in Karachi. The target population~     will be male and female school students in school grades 6 to 10 with intervention group and~     control group at each site. School-based educational intervention will be given to the~     intervention group while no specific education will be given to the control group.~     Differences in attitudes, knowledge and behaviors between the intervention and control groups~     will be compared each site separately before and after the intervention. The minimum sample~     size required was 22 schools (clusters). The number of subjects in each arm will be 529 with~     average cluster size of 50. The selected schools will be randomly assigned to a control group~     or Interventions group. Randomization will be done at the school level to avoid contamination~     between groups.The health education programme will be conducted for 3 consecutive weeks in~     one academic year for all the selected schools.~   "
11330|NCT03418493|"~     The purpose of this study is to evaluate how well LY3316531 is tolerated and what side~     effects may occur in healthy participants and participants with psoriasis. The study drug~     will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into~     a vein in the arm).~      This is a three-part study. Participants will enroll in only one part. Parts A and B are for~     healthy participants and Part C is for participants with psoriasis. Participation could last~     between 16 and 57 weeks.~   "
11331|NCT03418480|"~     HARE-40 is a phase I/II vaccine dose escalation study with two different arms: Arm 1A will~     perform intrapatient dose escalation in patients with previously treated HPV16+ Head & Neck~     Cancer using two dose cohorts to establish a safe, tolerable and recommended dose of HPV~     vaccine.~      Arm 1B will perform intrapatient dose escalation in patients with advanced HPV16+ cancer~     (head and neck, anogenital, penile or cervical) using a single cohort to establish a safe,~     tolerable and recommended dose of HPV vaccine.~   "
11332|NCT03418467|"~     Decision between rate control and rhythm control can be a challenge in clinical practice.~     While there is some guiding evidence, we still lack a comprehensive insight into different~     subgroups of patients that will benefit from a rhythm control treatment.~      EMPATHY is a prospective clinical study in patients presenting with heart failure and a~     tachyarrhythmic rhythm disturbance. Biomarkers, routinely obtained results from clinical~     examinations, and results from endomyocardial biopsies shall be evaluated to identify~     patients which have better outcome from a rhythm control strategy by ablation therapy or, if~     contraindicated by pharmacological rhythm control.~      This study is designed to identifying risk factors and subgroups profiting from rhythm~     restoration and therefore improve current therapeutic approaches and the rate of~     recurrence-free survival.~   "
11333|NCT03418454|"~     Oral squamous cell carcinoma (OSCC) is the most common malignant tumor of the head and neck,~     and its incidence has increased in recent years. Extensive surgery with neck dissection and~     chemo/radio/ targeted therapy is the current treatment for OSCC, and despite great progress~     in chemotherapy, radiotherapy, and targeted therapy in the last three decades, the prognosis~     of OSCC is still poor due to aggressive local invasion and metastasis, which lead to~     recurrence. Postoperative tumor recurrence confers a poor prognosis in OSCC and a poor~     quality of life. The 5-year survival rate is over 90% in OSCC patients without recurrence and~     30% in patients with recurrence, with a median survival of 76.8 months in patients without~     recurrence and 42.5 months in patients with recurrence . Therefore, it is important to~     identify biomarkers that may predict the postoperative recurrence of OSCC. Also, some of the~     OSCC are preceded by precursor lesions. In the oral cavity the most common lesions recognized~     as potentially malignant are leukoplakia and erythroplakia, but it is also apparent that as~     many as 50% of OSCC arise from apparently clinically normal mucosa. The prognostic~     significance of an individual lesion is difficult to determin. At present therefore, the gold~     standard for the assessment of oral potentially malignant lesions is microscopic evaluation~     of haematoxylin and eosin stained sections for the presence of architectural and cytological~     changes, which are generally referred to as oral epithelial dysplasia (OED). The human~     microbiome is defined as the collective genomes of the microbes (composed of bacteria,~     bacteriophages, fungi, protozoa and viruses) that live inside and on the human body, and~     there are approximately 10 microbes and 100 microbial genes for each human cell and gene~     respectively. With the advent of next generation sequencing technology, the Human Microbiome~     Project delineated the composition of healthy microbial communities associated to different~     body sites in healthy individuals, including the oral cavity [Human microbiome consortium].~     As opposed to a normal (healthy) microbiome, a disrupted microbiome or dysbiosis represents~     the lack of equilibrium, and is hypothetically related to disease. Interestingly, the healthy~     oral microbiome shows relative intraindividual stability over time, suggesting that~     differences in microbiome profiles may serve as useful tools for the identification of~     disease states. The working hypothesis is that in OSCC patients, the oral microbiome is~     altered in comparison to healthy individuals and certain microbial signatures are~     characteristic of healthy versus disease. In addition, in precursor conditions, i.e., oral~     epithelial dysplasia (OED), a partial alteration in the composition of the microbiome may~     predict the progression to malignancy.Also, during treatment, it could be that specific~     microbial signatures are associated with incomplete eradication, tendency to local recurrence~     or metastatic potential.Correlations to local recurrence (LR), distant metastases (DM) or~     disease free survival (DFS) adjusted to clinicopathologic correlations will be sought. In~     this study, buccal mucosa samples will be collected from patients with OSCC, OED and from~     healthy individuals , after signing for informed consent, according to Helsinky protocol.~     Routine pathologic diagnosis will be performed by expert Pathology physicians in our center.~     Data will be correlated to demographic and clinical data obtained from medical records. This~     will be carried out in line with institutional ethical guidelines.~   "
11335|NCT03418428|"~     The gastric barrier plays a major role in the maintanance of the distal intestinal microbiome~     composition. It has been shown before that the use of gastric acid suppression medication,~     such as proton pump inhibitors, are associated with distinctive alterations of the intestinal~     microbiome. Foremost, the invasion of predominantly oral bacteria, like Veillonella and~     Streptococcus species, were a resurring finding in previous reports.~      Gastric cancer treatment includes the total or subtotal resection of the stomach which can~     influence the gastric acid production. However, the influence by alterations in gastric~     milieu after this treatment on the composition of the intestinal microbiome is not well~     studied.~      Therefore, the intestinal microbiome of patients after total or subtotal gastrectomy and its~     influence on intestinal inflammation and gut permeability will be studied.~   "
11336|NCT03418415|"~     Sympathetic overactivity induces insulin resistance and type 2 diabetes mellitus (T2DM), so~     we assume that renal denervation (RDN) might improve glucose metabolism and insulin~     sensitivity. The purpose of this study is to evaluate the effects of multi-electrode~     catheter-based RDN on glucose metabolism and insulin sensitivity in patients with T2DM.~   "
11337|NCT03418402|"~     Airseal® is an insufflation management system for laparoscopic surgery which provides stable~     pneumoperitoneum, continuous smoke evacuation and valve-free access to the abdominal cavity.~     It allows an optimal exposure with a low-pression pneumoperitoneum, which is rarely possible~     with our standard insufflation system under a pneumoperitoneum of 12 millimetres of~     mercury(mmHg).~      The objective of this study is to compare the use of Airseal® system with a low pression~     pneumoperitoneum and our standard insufflation system usually used in our center in term of~     postoperative abdominal pain after laparoscopic hysterectomy for benign disease.~      This superiority prospective randomized trial is designed to include all patients > 18 years~     old referred for laparoscopic total hysterectomy for benign disease (with or without uni or~     bilateral annexectomy). Each patient would be randomized to one of this two following groups~     :~        -   Airseal®  group : use of AIRSEAL® to obtain stable low pression laparoscopy with a 8~          to 10 mmHg pneumoperitoneum.~        -   Standard laparoscopy  group : laparoscopy realised with our usual insufflation system~          and a 12 to 15 mmHg pneumoperitoneum.~      The primary end point is mean intensity of abdominal pain six hours after the end of surgery~     (H6), measured by simple numerical scale (ENS).~      The secondary end points are:~        -  peroperative endpoints : operative time, blood loss, use of additional ways of~          increasing exposure, peroperative complications, conversion to laparotomy, feeling of~          the surgeon regarding the difficulty of the surgery (measured by a simple numerical~          scale)~        -  early postoperative endpoints : intensity of abdominal pain at the entry in recovery~          room (H0), at twelve hours after the end of surgery (H12), twenty four hours (H24) and~          forty eight hours (H48) ; intensity of scapular pain at the same times (H0, H6, H12, H24~          and H48), need for analgesic administration (regarding to the standardized analgesic~          protocol), difference in the hemoglobin level before surgery and the first day after,~          early postoperative complications, necessity of a second surgery and the reason, length~          of hospital stay.~        -  late postoperative end points : estimated time to return to optimal quality of life,~          global satisfaction of patients evaluated by the Quality Of Life Questionnaire Short~          Form 12.~      It will be estimate that the use of Airseal® will reduce the mean abdominal pain at H6 post~     operative of 1 point on the simple numerical scale compared to our standard insufflation~     system, with a standard deviation of 1,5. Type 1 and 2 errors were set to the usual levels of~     0,05 and 0,20 respectively (power of 80%). Assuming a 10% withdrawal rate, the sample size~     would be 80 patients (40 patients in each group).~   "
11338|NCT03418389|"~     Hypophosphatasia is a rare inherited metabolic disorder due to inactivating mutations of the~     ALPL-Gene. Particularly among adult patients, clinical manifestation exhibits a broad range~     of signs and symptoms, most commonly associated with musculoskeletal disabilities and~     compromised quality of life. Enzyme replacement therapy with Asfotase alfa (AA) is available~     and approved for patients with pediatric onset of the disease.~      This single-center observational cohort study aims at collecting clinical routine data~     regarding the course treatment, quality of life and physical performance in patients treated~     with Asfotase alfa in line with the label for pediatric-onset hypophosphatasia.~   "
11339|NCT03418376|"~     Increasing evidence favours exercise therapy as an efficient tool to counteract inactivity~     related secondary symptoms in MS. Furthermore, exercise therapy may affect MS-associated~     muscle contractile and energy supply dysfunctions. So far, low to moderate intensity exercise~     rehabilitation has shown to induce small but consistent improvements in several functional~     parameters. High intensity exercise training in MS seems to further improve this. However,~     although results are promising, impairments in both muscle contraction and energy supply~     probably attenuate therapy outcome. In keeping with the above described physiological role of~     skeletal muscle carnosine and because muscle carnosine content may be lower in MS, the~     primary aim of the present project is to investigate whether carnosine loading improves~     exercise therapy outcome (exercise capacity, body composition) and performance in MS. If the~     latter hypothesis can be confirmed, muscle carnosine loading could be a novel intervention to~     improve exercise capacity and muscle function in this population.~   "
11340|NCT03418363|"~     A randomized study is to learn more about how a supplement called DHEA~     (dehydroepiandrosterone) affects clotting factors in women taking combined oral contraceptive~     pills. Current research suggests that the progestin hormone in a specific type of birth~     control pill may increase a woman's blood clot risk. However, it is unknown exactly how the~     progestin causes the increased risk. This study aims to learn if taking a daily dose of~     supplemental androgen (dehydroepiandrosterone, or DHEA) in addition to birth control pills~     containing DRSP affects proteins related to coagulation.~   "
11341|NCT03418350|"~     The primary objective of this study is to show that the Supraglottic Index (SGI) is an~     easily-collected index that accurately identifies the presence and severity of~     laryngopharyngeal reflux (LPF) in idiopathic pulmonary fibrosis (IPF).~   "
11342|NCT03418337|"~     Patients with atypical gastro-esophageal reﬂux disease (GERD), include cough, globus, and~     non-cardiac chest pain (NCCP) usually require more aggressive or double dose proton pump~     inhibitor (PPI) therapy than patients with typical GERD. Dexlansoprazole is a new, dual~     delayed release formulation of PPI that increases the mean intragastric pH during a 24-hour~     period. The prospective, open-label, randomized study aims to compare the efficacy of two~     different PPI formula in treating patients with atypical GERD symptoms.~      Patients with atypical GERD symptoms and a total Reflux Symptom Index (RSI) score ≥13 (cough,~     globus, and NCCP) will be invited to participate. Personal characteristics including age,~     sex, body mass index, and the severity of erosive esophagitis will be recorded. After~     enrollment, 120 subjects will randomly assign (at a 1:1 ratio) to receive either oral~     lansoprazole, Takepron OD 30 mg, once daily before breakfast or oral dexilansoprazole,~     Dexilant 60 mg, once daily before breakfast for 8 weeks. Subjects will record their symptoms~     (cough, globus, NCCP, heart burn, and acid regurgitation) at daytime and nighttime everyday~     via diary for 8 weeks. The primary endpoint is to compare the cumulated incidence of each~     symptom free during 8-week therapy period between the two study groups. The secondary~     endpoint will be the withdrawal or drop-out rate due to poor symptoms response or drug~     adverse effects.~      Data will be analyzed with SPSS Statistical Software for descriptive statistics (percentage,~     mean, standard error, and 95% confidence interval) and analytical statistics (chi-square~     test, ANOVA, and generalized estimation equation; GEE).~   "
11344|NCT03418311|"~     Preterm birth (PTB) complicates 13% of all pregnancies worldwide and is the most important~     cause of neonatal morbidity and mortality. Women with a twin pregnancy are at increased risk~     of preterm delivery. In the Netherlands, approximately 50% of women with a multiple pregnancy~     deliver before 37 weeks of gestation (WoG), of whom 9% deliver before 32 weeks. Evidence~     based treatment guidelines concerning prevention of PTB are not available in Europe.~     Expectant management is usual care with interventions only in terms of a tertiary prevention~     of PTB according to guidelines for premature rupture of membranes, premature labour or other~     pregnancy complications. The studies done on this topic included women at different stages of~     the second trimester so the question of the onset of cervix shortening and its impact on PTB~     is not answered yet. The critical period for a maximum impact of the pessary treatment on PTB~     is still to be verified. Up to now only the ProTwinTrial addressed the long-term outcome of~     the newborns, so here data and evidence is clearly missing. The investigators want to assess~     the impact of a cervical pessary treatment in twin pregnancies with cervical shortening on~     children's survival without neurodevelopmental disability at the age of 3 years at 3~     different stages of the second trimester (16-20 (early) vs. 20-24 (middle) vs. 24-28 (late)~     weeks of gestation).~   "
11345|NCT03418298|"~     Objectives: The primary objective of this study is to assess the feasibility of a~     internet-based preoperative exercise program in patients with esophageal or gastric cancers.~     Secondary objectives are to evaluate the effects of this preoperative program on functional~     capacity, anxiety and depression, quality of life, fatigue and markers of inflammation.~      Methods: This feasibility study will be conduct at University Hospital Saint-Luc in Brussels.~     Twenty patients with esophageal or gastric cancers will participate in internet-based program~     3 sessions per week. Each session will combine aerobic and resistance training. Moreover,~     inspiratory muscle strengthening (IMT) will be performed daily. The researcher will conduct~     weekly telephone calls to educate and motivate subjects. Assessments will be performed at~     baseline, after neoadjuvant treatment (if a neoadjuvant treatment is indicated), one day~     before surgery, 10 days after hospital stay and 3 months after surgery. The following~     parameters will be measured: functional capacity, quality of life, fatigue, anxiety and~     depression and markers of inflammation.~   "
11346|NCT03418285|"~     Trimethylamine-N-oxide (TMAO) is produced from the metabolism of gut microbiota and is~     reportedly pro-atherogenic and associated with cardiovascular events. The purpose of this~     study is to investigate the sequential change in TMAO levels by current optimal secondary~     prevention therapies in patients with ST-elevation acute myocardial infarction (STEMI) and~     the clinical impact of TMAO levels on the progression of atherosclerosis and subsequent~     cardiovascular events.~   "
11347|NCT03418272|"~     This study is being done to determine if the bacteria found in your mouth (oral flora~     bacteria) in children admitted to the intensive care unit who need to be on a breathing~     machine is different from the oral flora in healthy children undergoing anesthesia for their~     dental caries. Children in the intensive care unit with a breathing tube are at a higher risk~     for getting a lung infection due to the bacteria in the mouth slipping into their lungs past~     the breathing tube over several days. This means that bacteria are found in the child's lung~     when this is normally not the case. If the bacteria in the mouth have changed from normal~     then they may get a pneumonia.~   "
11348|NCT03418259|"~     The purpose of the study is to evaluate how treatment with Kinetic Oscillation Stimulation~     (KOS) in the nasal cavity in patients with Keratoconjunctivitis sicca can relieve these~     symtoms.~   "
11349|NCT03418246|"~     This study will test if applying calcium silicate cements (Biodentine) to restore cervical~     carious lesions might adversely affect the gingival health in comparison with conventionally~     used tooth colored material (GIC)~   "
11350|NCT03418233|"~     The main objective of the CIRCULATE project is to compare the clinical outcomes of CardioCell~     administration in treatment of ischemic damages of cardiovascular system with control group,~     who will receive the placebo.~   "
11351|NCT03418220|"~     Age-related macular degeneration (AMD) affects 2 million people in France. It characterized~     by progressive degeneration of the central area of the retina allowing detailed vision. It is~     the main cause of irreversible blindness in France. All patients initially present an early~     form, the latter can evolve in two different ways: the atrophic form, which progresses~     slowly, and the exudative or neovascular form, of more rapid evolution. While the treatment~     of exudative AMD has improved dramatically in recent years, there is currently no therapy for~     atrophic AMD. Recently, it has been demonstrated in atrophic AMD, an accumulation of~     inflammatory cells, macrophages, in the sub-retinal space. This space is located between the~     pigment epithelium (PE) and the photoreceptors. It is physiologically devoid of immune cells~     (immune privilege). Macrophages will secrete many pro-inflammatory molecules, such as~     cytokines. It has been shown in mouse models that some cytokines (IL-1beta, IL6 et TNFalpha)~     have a deleterious role on (PE) and photoreceptors. The identification of specific cytokines~     in the aqueous humor of patients with atrophic AMD would help to better understand this~     disease and consider potential targeted therapies. This study will be conducted in the~     ophthalmology department of the Croix-Rousse Hospital in Lyon. 80 patients will be recruited~     and divided into 4 groups: three experimental groups of 20 patients with : Early /~     Intermediate AMD, atrophic AMD or exudative AMD, and one control group of 20 patients without~     signs of AMD. Assays of the markers will be performed using the Luminex® technique on aqueous~     humor and blood samples collected for all patients during cataract surgery. The~     concentrations obtained in the aqueous humor will be normalized on their respective blood~     levels in order to confirm the intraocular secretion of these markers,. The identification of~     particular cytokine profiles in atrophic AMD compared to other forms of AMD would support~     emerging hypotheses of involvement of specific inflammatory cells in this pathology. There is~     currently no treatment available for atrophic AMD. If molecular screening identifies one or~     more specific biomarkers, targeted therapy may be considered.~   "
11352|NCT03418207|"~     Investigators plan to use modified TTMB technology to puncture prostate of participants~     suspected prostate cancer, especially those with the first negative biopsy , but having a~     rising PSA.Then, Investigators will simulate the spatial distribution of prostate cancer in~     patients with positive biopsy before radical prostatectomy by way of the TPS software system~     . And after the radical prostatectomy ,Investigators will simulate the spatial distribution~     with the help of large tissue slice technique to compare with preoperative simulation ,which~     to verify the two simulations are consistent.~   "
11353|NCT03418194|"~     The aim of this study was to observe the effect of transcutaneous acupoint electrical~     stimulation (TAES) on postoperative heart rate variability and high-sensitive cardiac~     troponin T of elderly patients with coronary heart disease.~   "
11408|NCT03417466|"~     The purpose of this study is to demonstrate the performance and safety of the Enlite Sensor~     over 144 hours (6 days) when inserted in the abdomen and used with the iPro2 in subjects age~     14 - 75 years.~   "
41563|NCT03022695|"~     This is a monocenter, open-label, uncontrolled study in accordance with §23b MPG to evaluate~     the efficacy of the HIFU-treatment of fibroadenoma using the TH-One device.~   "
11354|NCT03418181|"~     Patients who start haemodialysis usually retain some natural kidney function for months or~     years after starting dialysis. Even a small amount of this natural kidney function can be~     helpful in reducing the need for dietary and fluid restriction. There is also good evidence~     that retaining a small amount of natural kidney function may provide a survival benefit for~     patients on dialysis.~      Most patients who commence haemodialysis start three times per week for 3.5-4 hours per~     session, irrespective of the amount of natural kidney function they may have. An alternative~     approach used in some kidney units is to take account of the natural kidney function in~     prescribing the amount of dialysis. This may allow patients to start treatment needing to~     spend less time on dialysis or even to start just twice weekly. The amount of dialysis can be~     adjusted over time as natural kidney function declines. This is called incremental~     haemodialysis. Both of these approaches are considered to be standard care although it is~     not known which approach is more beneficial to patients.~      There are some suggestions that the frequency of dialysis may influence the rate of decline~     of natural kidney function but this need to be tested in a large randomised study. To inform~     the design of such a study, a smaller scale feasibility study is required.~      We intend to randomise fifty new starters on haemodialysis with adequate natural kidney~     function into two groups - a group who will have dialysis prescribed in the standard fashion~     - three times weekly for 3.5-4 hours per session or a group who will have an incremental~     start beginning with twice weekly treatment. We will investigate how many patients have~     sufficient natural kidney function to be eligible, whether patients are willing to~     participate and continue in the study, compare the rate of loss of kidney function between~     groups, and ascertain whether this individualised dialysis approach is less intrusive to~     patients. The results will be used to design a larger definitive study.~   "
11355|NCT03418168|"~     The purpose of this study is to evaluate the efficacy and safety of molidustat in peritoneal~     dialysis subjects with renal anemia~   "
11356|NCT03418155|"~     This study evaluates the efficacy and safety of TongBi capsule compared with placebo in the~     treatment of knee osteoarthritis in adults.Half of participants will receive TongBi capsule~     in combination,while the other half will receive a Placebo.~   "
11357|NCT03418142|"~     The trial aims to evaluate the effectiveness of a novel internet intervention (Priovi), which~     was designed to introduce relevant schema therapy techniques to Persons with Borderline~     Personality Disorder (BPD). Therefore, 200 people with BPD will be recruited and randomized~     to two groups: (1) a control group, in which they may engage with any BPD treatment~     (Care-as-Usual, CAU) and receive access to Priovi after a delay of 12 months (i.e., CAU/wait~     list control group), or (2) to a treatment group that immediately receives 12-month access to~     Priovi and may also use CAU. The primary outcome measure is the score of the Borderline~     Personality Disorder Severity Index (BPDSI), collected at three, six and 12 month~     post-baseline.~   "
11358|NCT03418129|"~     Traumatic brain injury (TBI) and chronic pain are common and serious health problems for~     military veterans and often co-occur, leading to poor post-deployment adjustment.~     Pharmacological treatments for pain elevate risk of opioid abuse, and research suggests~     veterans perceive barriers to existing non-pharmacological, clinic-based treatments. Thus,~     there is an urgent need to develop pain management approaches that are effective, overcome~     barriers to care, and are readily usable by Veterans. Evidence suggests that neuromodulatory~     treatments, grounded in understanding of neurophysiological mechanisms of pain, reduce~     pain-related symptoms and have the potential to be developed into self-directed treatments~     through use of mobile technology.~   "
11359|NCT03418116|"~     The study is conducted to evaluate the safety and benefit of the Argus II System in a~     selected patient population with advanced Retinitis Pigmentosa who have a measurable central~     residual visual field smaller than or equal to 5 degrees radius.~   "
11360|NCT03418103|"~     Rinicare Ltd, a Lancaster-based SME, and University Hospitals of Morecambe Bay Trust (UHMB)~     will collaborate on a research study to determine the feasibility, suitability, and~     acceptability of the Rinicare developed SAFE (System to Avoid Fall Events) fall prevention~     and detection system in a hospital environment. The study is designed to determine if the~     implementation of the SAFE system will help clinicians to prevent in-patient falls from~     hospital beds. In-patient falls are a serious problem with more than 245,000 incidents~     reports in 2015-2016. 77% of these falls involve a patient over the age of 65, and the~     injuries patients suffer due to falls is estimated by NICE to cost the NHS £2.3B annually.~     This study will test the performance of the SAFE technologies against the current~     interventions to prevent falls, and it will investigate the impact of the SAFE technology on~     the workflow of the carers.~      The SAFE study is designed as a comparison study combining a descriptive, quantitative~     methodology measuring the number of fall events with a normative analysis of the qualitative~     aspects experienced by the clinicians using the SAFE system during the project period.~      The primary research objective of this study is to determine if the implementation of the~     SAFE system will quantifiably reduce the number of fall events in the ward compared to a~     similar control period. The secondary research objective is to determine if the SAFE system~     has a positive or a negative impact on the ward staff's workflow, i.e. the ability of the~     ward staff to provide care to the patients.~   "
11361|NCT03418090|"~     This study compares the equivalence of hyperpolarized 129Xe MRI to 133Xe scintigraphy for the~     evaluation of pulmonary function in patients being evaluated for lung transplant.~   "
11362|NCT03418077|"~     The purpose of this study is to determine the effects of consuming Monster Energy® original~     flavor drink on electrocardiographic (ECG) and hemodynamic responses during and after~     exercise in healthy subjects. The effect of drinking Monster Energy® on exercise performance~     will also be evaluated.~   "
11363|NCT03418064|"~     The aim of this prospective study is to evaluate the clinical performance of fanfilcon A~     toric and lotrafilcon B toric contact lenses after 1 month of wear in each pair.~   "
11364|NCT03418051|"~     ABSTRACT:~      Injury associated with sport and recreation is a leading reason for physical activity~     cessation, which is linked with significant long-term negative consequences. Lateral ankle~     sprains are the most common injuries associated with physical activity and at least 40% of~     individuals who sprain their ankle will go on to develop chronic ankle instability (CAI), a~     multifaceted condition linked with life-long residual symptoms and post-traumatic ankle~     osteoarthritis. Our long term goal is to develop intervention strategies to decrease~     disability associated with acute and chronic ankle injury and prevent posttraumatic ankle~     osteoarthritis. Conventional rehabilitation strategies, are only moderately successful~     because they ignore the full spectrum of residual symptoms associated with CAI. Manual~     therapies such as ankle joint mobilizations and plantar massage target sensory pathways not~     addressed by conventional treatments and have been shown to improve patient-reported~     outcomes, dorsiflexion range of motion, and postural control in CAI patients. While these~     early results are promising, the underlying neuromuscular mechanisms of these manual~     therapies remain unknown. Therefore the objective of this R21 proposal is to determine the~     neuromuscular mechanisms underlying the improvements observed following independent ankle~     joint mobilization and plantar massage interventions in CAI patients. To comprehensively~     evaluate the neuromuscular mechanisms of the experimental treatments, baseline assessments of~     peripheral (ankle joint proprioception, light-touch detection thresholds, spinal (H-Reflex of~     the soleus and fibularis longus), and supraspinal mechanisms (cortical activation, cortical~     excitability, and cortical mapping, sensory organization) will be assessed. Participants will~     then be randomly assigned to receive ankle joint mobilizations (n=20), plantar massage~     (n=20), or a control intervention (n=20) which will consist of 6, 5-minute treatments over~     2-weeks. Post-intervention assessments will be completed within 48-hours of the final~     treatment session. Separate ANOVAs will assess the effects of treatment group (ankle joint~     mobilization, plantar massage, control) and time (baseline, post-treatment) on peripheral,~     spinal, and supraspinal neuromuscular mechanisms in CAI participants. Associations among~     neuromuscular mechanisms and secondary measures (biomechanics and postural control) will also~     be assessed. The results of this investigation will elucidate multifaceted mechanisms of~     novel and effective manual therapies (ankle joint mobilizations and plantar massage) in those~     with CAI.~   "
11365|NCT03418038|"~     This randomized phase II trial studies how well ascorbic acid and combination chemotherapy~     work in treating patients with lymphoma that has come back or does not respond to therapy.~     Ascorbic acid may make cancer cells more sensitive to chemotherapy. Drugs used in~     chemotherapy, work in different ways to stop the growth of cancer cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. Giving~     ascorbic acid and combination chemotherapy may work better at treating lymphoma.~   "
11366|NCT03418025|"~     This pilot clinical trial studies how well the Exercising Together program works in helping~     couples cope with radiation treatment for prostate cancer. Treatments for cancer can cause~     side effects for the patient, such as fatigue, add stress for the spousal caregiver, and put~     strain on the marital relationship. The Exercising Together program is designed to promote~     teamwork and emotional intimacy during exercise, which itself can help manage fatigue and~     stress for the patient and spouse, and may facilitate communication between partners about~     day-to-day energy, abilities, and motivation.~   "
11367|NCT03418012|"~     Prevention of preterm birth (PTB) is a key factor for a positive short-term and long-term~     outcome of the newborn children as mortality and morbidity are inversely related to~     gestational age at delivery. Consequently every week of prolonged pregnancy will have a~     tremendous effect concerning the outcome of the new-borns, subsequently for their parents and~     society as well.~      The proposed RCT aims to evaluate the impact of a preventive pessary treatment on the~     prevention of preterm birth in women with a singleton pregnancy who are at high risk of~     spontaneous preterm birth (sPTB) due to a history of at least one previous preterm delivery~     and/or a history of previous cervical surgery. In accordance with the results by van´t Hooft~     et al. 2016 an approximately 20% higher percentage of children's long-term survival without~     neurodevelopmental disability is expected for the pessary group in comparison with usual~     management (=control group) on basis of a reduction of prematurity < 34 week of gestation~     (WoG).~      The primary outcome measure for the effect of the pessary treatment in comparison to~     expectant management will be the children's long-term survival (3yrs) without~     neurodevelopmental disability. Secondary endpoints assess the impact of a preventive pessary~     placement on the prevention of preterm birth and its resulting risk on mortality and~     morbidity for the neonates.~   "
11368|NCT03417999|"~     The main objectives of the study are to determine peak plasma drug concentration levels and~     corresponding time of dexmedetomidine following intranasal administration in children age ≥1~     mo to ≤ 6 yr with congenital heart disease undergoing an elective diagnostic or~     interventional cardiac catheterization procedure.~   "
11369|NCT03417986|"~     This proof-of-mechanism clinical trial study will test the efficacy and safety of~     thiethylperazine (TEP) in subjects with early onset of Alzheimer's Disease (AD). There is a~     strong scientific rationale for this study: TEP is a very well-known substance that has been~     available since 1961 and approved for the prevention and treatment of nausea, vomiting as~     well as vertigo. Therefore, it has a well understood pharmacologic background and promising~     safety data. Using AD mouse models, it has been recently discovered and confirmed that TEP~     promotes transport of toxic Aβ from the brain into the blood. More importantly, it has also~     been demonstrated to improve learning deficits in mice. The striking biological effect of TEP~     in preclinical testing and its known safety and toxicity profile encourages the investigators~     to investigate this in a multicenter clinical trial in subjects with early-to-mild AD in~     comparison to healthy volunteers. The investigators will assess whether TEP is able to~     enhance the transport of Aβ peptides from the brain into the blood in subjects with~     early-to-mild AD and improves cognitive efficacy.~   "
11370|NCT03417973|"~     ACTIVE study- a prospective observational clinical study examining the changes in quality of~     life and pain following dorsal root ganglion stimulation for the treatment of chronic~     intractable pelvic and lower limb pain.~   "
11371|NCT03417960|"~     The investigators are studying the feasibility and tolerability of 6x/day intermittent theta~     burst (excitatory) transcranial magnetic stimulation to the left dorsolateral prefrontal~     cortex over the course of 3 days for women with post-partum depression. The investigators~     further hope to characterize the anticipated anti-depressant effect of this treatment~     paradigm.~   "
11372|NCT03417947|"~     Sickle cell disease (SCD) is a genetic disease characterized by abnormal hemoglobin, the main~     constituent of red blood cells. People with SCD have nutritional deficiencies, and vitamin D~     deficiency is one of the most common. Symptoms of vitamin D deficiency are similar to those~     of SCD and include chronic pain and bone complications. Correcting vitamin D nutrition of~     children with SCD represents a treatment that will improve their health. A single oral~     high-dose of vitamin D3 will be given to SCD children during one of their follow-up visits at~     the SCD clinic of CHU Sainte-Justine, Montreal, Canada. This mode of administration was~     chosen to ensure a better adherence to the treatment. The investigators will determine~     whether this dose is safe and its administration feasible in clinic. The impact of this dose~     on blood vitamin D and calcium, urinary calcium, growth, inflammation, bone health, pain and~     quality of life will also be assessed. This study intends to propose a new intervention to~     improve the nutrition of children with this disease.~   "
11373|NCT03417934|"~     The purpose of this pilot study is to evaluate the effects of hip distraction without a~     perineal post on the lower extremity during hip arthroscopic procedures by peri-operative~     monitoring of various prognostic markers for venous, nerve and tissue injury.~   "
11374|NCT03417921|"~     A phase I/II open label study to assess the efficacy and safety of ABTL0812 in combination~     with gemcitabine and nab-paclitaxel in patients with advanced metastatic pancreatic cancer at~     first line therapy and as maintenance therapy after chemotherapy~   "
11375|NCT03417908|"~     To evaluate the activation of accessory respiratory muscles and the effects of stretching~     these muscles in patients with COPD.~   "
11376|NCT03417895|"~     This is a multi-center, open-label, phase II study of intravenous (IV) SHR-1210 at 200mg,q2w~     in combination with Apatinib at one dose (375mg). Comparison of 3 different dose schedules in~     subjects with extensive-stage disease small cell lung cancer. SHR-1210 is a humanized~     monoclonal antibody against Programmed death 1(PD-1). Apatinib is a new kind of selective~     Vascular Endothelial Growth Factor Receptor 2(VEGFR-2) tyrosine kinase inhibitor (TKI).~      The study is composed of two parts. Part 1 of the study will determine the safety and~     tolerability of SHR-1210 in combination with Apatinib in first 6 subjects of each arm. Part 2~     of the study will determine the safety and efficacy of SHR-1210 in combination with Apatinib~     in 45 subjects of each arm.~   "
11377|NCT03417882|"~     This is a non-randomized, Phase 2, 2-cohort, 2-stage, open-label, multi-center study of~     GRN-1201/sargramostim + pembrolizumab in subjects with PD-L1+ metastatic NSCLC. Both first~     and second line subjects will be enrolled including:~        -  Cohort 1: Subjects with newly diagnosed, metastatic PD-L1+ (TPS ≥ 50%) NSCLC with no~          epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic~          tumor aberrations, or~        -  Cohort 2: Subjects with metastatic PD-L1+ (TPS ≥ 1%) NSCLC with progression on or after~          first-line platinum-based regimen. Subjects with EGFR or ALK genomic tumor aberrations~          with progression on FDA-approved therapy for these aberrations are eligible~   "
11378|NCT03417869|"~     Demonstrate improved clinical performance of visually read QuickVue Influenza A+B test.~   "
11379|NCT03417856|"~     Ichthyosis is a group of genetic skin disorders that present with dry, thickened, scaly, or~     flaky skin. As of today, there is no cure or treatment. Doctors can only treat the dry skin~     with different types of emollients to soften the scale. A deeper understanding of this~     disease is required to develop better treatments. There are different types of cells and~     cell-produced signals (biomarkers) that are being studied in order to help find these new~     treatments. Looking at biomarkers has been successful in helping us to understand other skin~     disorders better. The purpose of this study is to determine which blood and skin biomarkers~     characterize ichthyosis.~      Hypothesis: We predict that the biomarkers correlating with disease activity in Netherton~     syndrome will be different than the biomarkers found to correlate with the lamellar and other~     ichthyosis phenotype.~   "
11380|NCT03417843|"~     This study aims to evaluate the safety and efficacy of new ablation catheter developed by~     MEDICAL TAEWOONG for the treatment of pancreatic premalignant and early malignant cystic~     lesion. The ablation is performed using EUSRA needle and radiofrequncy waves under ultrasound~     imaging. The method will be exaimened on patients who are candidates for surgical~     intervention and to examine the ability of the method to serve as an alternative to surgical~     intervention.~   "
11381|NCT03417830|"~     The principal aim of this study is to investigate the cardiac uptake of 89Zr-GSK2398852 in~     subjects with transthyretin cardiomyopathy amyloidosis (ATTR-CM), and its biodistribution to~     other organs. Low doses of GSK2398852 will be co-administered at levels not high enough for~     therapeutic benefit. This study will be conducted in two parts: Part A and Part B. Subjects~     in Part A will participate in up to two dosing sessions and subjects in Part B will~     participate in one dosing session. Subjects will undergo up to 3 PET scans at varying~     intervals after 89Zr-GSK2398852 administration. The total duration of study will be~     approximately 3 to 4 months for subjects in Part A and approximately 2 months for subjects in~     Part B. Part B of the study will be triggered based on data obtained in Part A and other~     emerging data.~   "
11382|NCT03417817|"~     First introduced over 40 years ago, the 24-hour catheter-based pH studies have previously~     been found to be the gold standard for the diagnosis of acid reflux. In 2003, the Bravo™ pH~     wireless monitoring revolutionised the study of gastroesophageal reflux disease (GORD),~     allowing patients an improved comfort and ability to perform activities of daily living.~     Normal ranges for acid exposure are established for 48-hour studies. However, the~     investigators' studies have shown that extending the duration of recording to 96 hours~     further improved diagnostic yield and consistency in patients with negative 24-hour~     catheter-based studies. The 96-hour recording is the current standard of care, despite the~     lack of normal ranges for this duration of the recording. The basis for the diagnosis of GORD~     in 96-hours studies is based on the 48-hours normal controls. The objective of this study is~     to determine the normal values for oesophageal acid exposure using the wireless pH recording~     apparatus over 96 hours in asymptomatic healthy subjects with unrestricted activity and diet.~   "
11383|NCT03417804|"~     This is an epidemiological multicenter, observational, prospective study, designed to~     determine the incidence of postoperative residual neuromuscular blockade - defined by a TOF~     (train-of-four) ratio < 0.9 - at PACU arrival.~      Subjects aged at least 18 years old (n=360) admitted for different types of elective surgical~     procedures requiring general anesthesia with neuromuscular blocking agents will be included.~   "
11384|NCT03417791|"~     The aim of our study is to assess the mortality in the in-hospital patients who have elevated~     serum creatinine. A registry of patients with increased serum creatinine during hospital was~     conducted at the Guangdong General Hospital from January 1st, 2007 to December 30th, 2013.~     The primary clinical outcome is all-cause mortality, followed from the date of hospital~     discharge to Dec 30th 2018. Patients were divided into three groups, according to the serum~     creatinine recovery ratio (discharge/max serum creatinine). All-cause mortality, including~     the date of death, was identified from the electronic hospitalization data, phone follow-up,~     and confirmed by the household registration (HUKOU) system, a record of registration required~     by law in China. Baseline characteristics, including primary disease diagnosis, blood~     pressure, major treatment, drug use and et al, were collected. Demographic data were~     collected from the electronic hospitalization data and electronic hospital discharge records.~     All co-morbid conditions were identified using International Statistical Classification of~     Diseases, Tenth Revision (ICD-10), coding algorithms applied to electronic physician claims~     and electronic hospital discharge records.~   "
11385|NCT03417778|"~     The primary objective of this study is to evaluate the pharmacokinetics (PK) of filgotinib~     and its metabolite, GS-829845, in participants with varying degrees of impaired hepatic~     function relative to matched, healthy controls.~   "
11396|NCT03417635|"~     Approximately 30% of community-dwelling older adults experience one or more falls per year,~     resulting in injuries, loss of independence, and reduced quality of life. While there are~     known physiological risk factors for falls, including poor balance and altered gait patterns,~     it is now recognized that impaired cognitive functioning is also a risk factor for falls.~     Within the broad construct of cognition, one specific domain that has been focused on in the~     falls literature is attention. The literature suggests that improving attention in those~     at-risk for falls may reduce older adult's risk of falling.~   "
11438|NCT03417076|"~     The purpose of this study is to determine the absolute bioavailability of bexagliflozin~     following a single oral dose co-administered with an intravenous dose.~   "
14042|NCT03383081|"~     The purpose of this study is verify the efficacy and safety of Human Umbilical Cord~     Mesenchymal Stem Cells (UC-MSC) therapy for patients with Osteoarthritis, and in addition,~     provide basis for exploring the treatment regimen of UC-MSC therapy in different degree of~     cartilage defect disease~   "
11386|NCT03417765|"~     RATIONALE:~      The integrity of the intestinal mucosa is a key factor for the preservation of a normal gut~     function. Damage of the epithelium (i.e. by chemotherapy) results in significant cellular and~     molecular alterations that ultimately lead to intestinal dysfunction/failure. This intestinal~     dysfunction manifests as several pathological processes, such as inability to absorb~     nutrients, intestinal inflammation, immune system dysregulation, and disequilibrium of normal~     intestinal microbiota leading to increased risk of infection due to bacterial translocation~     and septicaemia. Gastrointestinal (GI) mucositis is a well-known, frequent and debilitating~     side effect of most anticancer regimens with a very high incidence in hemato-oncology. The~     most common symptoms are nausea, vomiting, weight loss, abdominal cramps and pain, diarrhea,~     and electrolyte imbalance. Patients may also experience ulceration/bleeding and injury of the~     lining of the entire gastrointestinal tract from the esophagus to the colon. Currently no~     therapy is available for the prevention or treatment of GI intestinal injury. Treatment of~     related symptoms is limited to supportive measures to decrease diarrhea and to preventive~     antibiotic therapy. The GLP-2 analogue, FE 203799, has a favorable pharmacology profile for~     clinical development in the intended therapeutic indication of myeloablative~     chemotherapy-induced GI damage. The data collected from animal studies has shown that FE~     203799 stimulates the proliferation of the intestinal epithelium and protects the GI mucosa~     from chemotherapy-induced injury. Hence, the primary pharmacologic activity of FE 203799~     would promote a healthy GI microenvironment, thus preventing intestinal dysfunction and~     related complications.~      PURPOSE: Prevention by FE 203799 of chemotherapy-induced intestinal damage and related~     complications in patients with lymphoma receiving Melphalan based (BEAM) myeloablative~     conditioning regimen followed by hematopoietic stem cell transplantation.~   "
11387|NCT03417752|"~     This pilot study seeks to determine if exposure to the firearm safety PSA developed by the~     U.S. Department of Veterans Affairs (VA) is associated with changes in related beliefs and~     safe storage practices. Participants are randomly assigned to message exposure or control~     conditions. Data from this project will inform injury prevention outreach efforts targeted~     towards Veteran populations.~   "
11388|NCT03417739|"~     This research study is studying a targeted therapy called BVD-523 as a possible treatment for~     advanced uveal melanoma.~   "
11389|NCT03417726|"~     This study aims to evaluate Pediatric Balance Scale and quantitative balance and gait~     parameters assessed by Balance Master force plate in Cerebral Palsy (CP) patients who are~     ambulatory without an assistive device in daily life.~   "
11390|NCT03417713|"~     The purpose of this study is to collect feedback on imaging guidance adequacy from physicians~     who use the OEC™ Elite CFD Mobile Fluoroscopy System—Motorized Configuration to perform~     surgical procedures for which the use of mobile fluoroscopy is prescribed per standard of~     care.~      Up to 40 eligible subjects will be enrolled and have their clinically indicated procedure~     completed using the investigational device.~      Following completion of each subject's procedure, the investigators will complete a User~     Survey specific to the workflow and guidance adequacy of the OEC Elite device. The survey~     will consist of a series of questions on the use of the system as well as anonymized image~     data.~      After all subjects' procedures are completed at a given site, the site investigator will~     review survey data from the study subjects enrolled at the site and document his/her~     assessment of the overall acceptability of the system for use in a clinical environment.~      There is no statistical hypothesis being tested in this study. Results will be summarized~     using descriptive statistics.~   "
11391|NCT03417700|"~     Physical activity is a recommended, indispensable element of a healthy lifestyle as well as a~     countermeasure against many diseases often accompanied by the acute or chronic low grade~     inflammation. Papers published in recent years have demonstrated the anti-inflammatory effect~     of exercise. Based on current knowledge of the topic, own experience and preliminary work, it~     is expected the proposed research to provide information on the mechanism either determining~     or limiting pro-healthy effects of exercise in different age groups of people. Three~     different training programmes will be investigated. Specific goals of the project include the~     following:~        1. Establish, whether regular Nordic Walking training and HIIT can reduce the low-grade~          systemic inflammation and which type of training is the most effective at doing so.~        2. Establish, whether regular training can prevent muscle sarcopenia and assess if those~          changes are related to the concentration of the autophagy-inducing stress protein,~          HMGB1.~        3. Establish, whether regular Nordic Walking training alters iron metabolism and evaluate~          its correlation with the inflammatory markers and bone-morphogenesis.~        4. Establish, whether muscle-released irisin signals growth in the BDNF concentration in~          response to exercise and if these changes improve cognitive function.~        5. Establish, whether Nordic Walking or HIIT training effectively improve the blood lipid~          profile and aerobic capacity, and if these effects correlate with the blood 25-OHD~          concentration.~        6. Establish, whether concentration of vitamin D alters adaptation to training and modifies~          immunological response to regular training process.~   "
11392|NCT03417687|"~     This study compares the equivalence of hyperpolarized 129Xe MRI as compared to 133Xe~     scintigraphy for the evaluation of pulmonary function in patients being evaluated for lung~     resection.~   "
11393|NCT03417674|"~     Background: Overweight and obesity affect health, quality of life and ability to work.~     Therefore, the scientifically evaluated program SHAPE AND MOTION - medically ◦ accompanied ◦~     slimming was developed to support overweight and obese people in weight loss.~      Method: In a randomized controlled clinical trial, the effect of a lifestyle intervention~     with meal replacement by formula diet, exercise stimulation, and telemedicine coaching is~     examined compared to a control group with routine care. The learning contents are taught in 7~     group trainings, a practical unit with shopping and cooking training, as well as in 4~     individual telephone conversations. The state of health is examined at the beginning, after~     12 and 26 weeks.~      Objective: The aim is to develop a training and counseling program for overweight or obese~     individuals with diabetes risk or type 2 diabetes, which can be used both for primary and for~     tertiary prevention of overweight-related diseases.~   "
11394|NCT03417661|"~     This study evaluates the antimicrobial properties of HEXI-PREP by Clinell compared to both a~     negative and a positive control product.~   "
11395|NCT03417648|"~     The purpose of the study is to assess whether, in individuals with rheumatoid arthritis, a~     low-fat, vegan diet improves pain and other subjective symptoms more effectively than a~     control supplement or a placebo. The principal measure is pain as measured by Visual Analog~     Scale (VAS) and disease activity as measured by number of painful swollen and tender joints,~     respectively. The study duration is 36 weeks.~      This study tests that a low fat, plant-based (vegan) diet free of foods commonly identified~     as triggers improves mood, using the Center for Epidemiologic Studies Depression~     Scale-Revised (CESD-R), and the Beck Depression Inventory II (BDI-II).~   "
11397|NCT03417622|"~     Breast cancer patients often receive systemic drugs as the initial curative treatment of~     their disease. The initial systemic therapy leads to a variable degree of tumor shrinkage. At~     present, there is no evidence-based consensus among breast surgeons on the optimal extent of~     resection after considerable tumor shrinkage and whether resection margin should be designed~     according to the tumor extent before treatment or the extent after treatment. This trial will~     help determine the optimal extent of resection in tumors that exhibits a significant change~     in volume after primary systemic therapy.~   "
11398|NCT03417609|"~     Sarcopenia is a syndrome characterized by a progressive and generalized loss of skeletal~     muscle mass, strength and function that increases the risk of physical dependence, impaired~     quality of life and mortality. This is a major public health problem. Indeed, its prevalence~     has been estimated at 63.8% for elderly patients hospitalized in acute geriatric unit.~      Several methods of sarcopenia screening exist at present. The European Working Group on~     Sarcopenia in Older People (EWGSOP) proposes to carry out three examinations for the~     diagnosis of sarcopenia: the Dual-Energy X-ray Absorptiometry (DEXA) test and two motor tests~     (walking speed and hand test). These measurements have already been evaluated and validated.~     They are reliable, inexpensive and easily achievable in clinical routine.~      Recent studies have shown that decreased muscle mass and / or strength could be associated~     with dysphagia. Indeed, many muscles of the head and neck are simultaneously solicited for~     swallowing coordination. This suggests that a reduction in the mass or strength of these~     muscles could impact the swallowing function. The investigator's hypothesize that loss of~     lingual muscle strength may be associated with sarcopenia. The study will measure the tongue~     strength using the Iowa Oral Performance Instrument (IOPI) in a geriatric population with or~     without sarcopenia.~        -  Determine the incidence of lingual hypotonia in hospitalized elderly sarcopenia~          patients.~        -  To compare the sensitivity, the specificity of the measurement of the force of the~          tongue with the usual measures proposed by the EWGSOP in the context of screening for~          sarcopenia.~   "
11399|NCT03417596|"~     Abstract: Introduction:~      Vestibular migraine(VM) is a disease that manifests with episodic vertigo attacks in patients~     with or without migraine type headaches, when present accompanying the headaches. Its~     prevalence was found out as %1 in a study in Germany. It usually involves middle aged women.~     VM can make a huge impact on quality of life, therefore advances in its diagnosis and~     management are valuable. While pharmacotherapy that is being used in migraine can be~     beneficial, vestibular rehabilitation(VR) programmes are predicted to be one of the most~     important types of treatment in management of VM. This study compares the results of~     pharmacological management options and vestibular rehabilitation programmes in the context of~     dizziness, balance problems and headache.~      Material and methods:~      77 patients with VM were included in study, and 60 of them completed it. While one group took~     only VR programme, and another took only pharmacological prophylaxis. The third group took a~     combined therapy, and the groups were consisted of 20 patients. Patients were assessed with~     caloric tests, audiometric studies, static posturography, Dizziness Handicap Inventory(DHI),~     and Activities Specific Balance Confidence(ABC) scales. All of the assessments were applied 3~     times throughout the study, and the results were compared with relevant statistical tests.~   "
11400|NCT03417583|"~     Phase A: Recruit 50 patients with HD, and their caregivers, to complete a neuropsychiatric~     and quality of life battery of scales at baseline. Have these 50 patients complete a formal~     psychiatric assessment with a psychiatrist within 2 weeks of this clinical battery, and the~     results of these 2 types of assessments will be compared to establish the level of agreement~     between clinical rating scales and formal psychiatric assessment.~      Phase B: Continue to follow Phase A cohort longitudinally and administer neuropsychiatric and~     quality of life battery at 6 months, 12 months, and 18 months form baseline. Recruit an~     additional 50 patients, administer the same neuropsychiatric and quality of life battery at~     baseline, implement medication and counseling intervention according to a standard of care~     protocol, and follow up with the same neuropsychiatric and quality of life battery at 6, 12,~     and 18 months.~   "
11401|NCT03417570|"~     The hypothesis is that the addition of a transparent cap to the end of the endoscope will~     increase the detection and diagnostic yield of visible lesions in Barrett's esophagus. Thus,~     the goal of this tandem design trial is to compare the diagnostic yield (DY) of cap assisted~     endoscopy with that of conventional endoscopy using high definition-white light endoscopy~     (HD-WLE) and narrow band imaging (NBI) in patients with Barrett's esophagus.~   "
11402|NCT03417544|"~     This research study is studying a drug called atezolizumab as a possible treatment~     HER2-positive metastatic breast cancer (MBC) that has spread to the brain.~      The names of the study drugs involved in this study are:~        -  Atezolizumab~        -  Pertuzumab~        -  Trastuzumab~   "
11403|NCT03417531|"~     Physical inactivity and protein malnutrition have been implicated to be key and modifiable~     causes of enhanced muscle mass loss among seniors. However, the individual benefit, as well~     as the additive or possibly interactive benefit of exercise and Protein supplementation on~     fall prevention has yet to be confirmed in a large clinical trial. This study aims to test~     the individual and combined effect and cost-effectiveness of a simple home exercise program~     and / or protein supplementation on the risk of falling in seniors at high risk of~     progressive muscle mass loss and sarcopenia.~   "
11404|NCT03417518|"~     Evaluate the effects of propofol compared with desflurane on oxidative stress and~     inflammation markers in obese patients undergoing scheduled bariatric surgery.~   "
11405|NCT03417505|"~     Tangible Hydra-PEG is a novel coating technology designed to improve lens wettability,~     deposit resistance, and tear film breakup time. This is a randomized double masked cross-over~     study to examine contact lens discomfort and dry eye symptoms with Tangible Hydra-PEG treated~     scleral lens wear compared to untreated scleral lens wear in the dry eye patient population.~   "
11406|NCT03417492|"~     Investigators will measure cerebrovascular reactivity (CVR) using functional near-infrared~     spectroscopy (fNIRS) and magnetic resonance imaging (MRI) during the chronic phase after~     repetitive mild traumatic brain injury (rmTBI) as a biomarker of traumatic cerebrovascular~     injury (TCVI). We hypothesize that CVR will be decreased in patients with rmTBI and that~     these decreases will correlate with clinical outcomes. Furthermore, we predict that 5 week~     administration of a phosphodiesterase 5 (PDE5) inhibitor, sildenafil citrate, will augment~     CVR in patients with a history rmTBI.~   "
11409|NCT03417453|"~     One aspect to eye drop adherence is successful instillation of the drops; however, it is well~     known that many patients struggle with this task. Difficulties may include aiming their~     drops,extending their neck, preventing excess drop leakage, avoiding contamination of the~     bottle tip and generating enough force to expel a drop from the bottle. Instillation aids are~     devices that aim to ameliorate one or more of these barriers.~      Several eye drop dispensers had been developed in order to improved outcomes of eye drop~     instillation, including improved rates of successful administration and increased patient~     satisfaction compared to standard eye drop bottles.~      In this study we aim to compare the eye drops various installation aids~   "
11410|NCT03417440|"~     The purpose of this study is to develop, test, and optimize a physical activity (PA)-tracking~     smartphone app and specialty features, which are designed to facilitate older adults' PA by~     targeting common barriers in this population. For example, one feature sends messages~     throughout the day about the good things about growing older to combat negative views about~     aging which has been linked to decreased PA. Participants will include older adult smartphone~     users who are between the ages of 65 and 84 and are not very physically active. In phase one~     of the study, three groups of five older adults will be formed to test the PA-tracking app~     and one of three specialty features for a two-week period, followed by a focus group to learn~     about the older adults' experiences. In phase two, approximately 100 participants will be~     randomly assigned to one of eight groups that include various combinations of specialty~     features with the PA tracker, for the purpose of pilot testing the app for a four-month~     period. Testing will occur at the beginning and the end of the four-month intervention~     period, and will measure PA levels, sedentary activity time, self-reported PA, and functional~     mobility.~   "
11411|NCT03417427|"~     It is often impossible to find therapeutic target in intermediate-risk AML, so it is very~     important to select appropriate chemotherapy protocol to eliminate minimal residual disease~     (MRD) in these AML patients. Recent studies demonstrated that leukemia microenvironment is~     the shelter nich for leukemia stem cells and the essential reason for impossibly eliminating~     MRD. Demethylation drug not only prove the effect of chemotherapy, but also change leukemia~     microenvironment through epigenetics modification. Both of them will result in eliminating~     MRD in patients with AML. The investigators designed a multicenter randomized control~     clinical trail to evaluate the effect of demethylation drug combined with chemotherapy in AML~     patients with intermediate-risk factors after hematological complete remission. Efficacy will~     be evaluated through MRD detected by flow cytometry every 1 month. Continuous negative MRD~     indicates a good prognosis. The patients with continuous negative MRD can select auto-HSCT or~     consolidation chemotherapy, those with continuous positive MRD should be considered as~     candidates of allo-HSCT. Overall survival and relapse free survival will be recorded after~     follow-up every 3 months. It will provide a basis for precision therapy and a new way for~     designing a novel protocol for intermediate-risk AML. This clinical trail will benefit to the~     AML patients with intermediate-risk factors.~   "
11412|NCT03417414|"~     This is an observational cohort study of patients with a new diagnosis of B cell Chronic~     Lymphocytic Leukemia or B cell Non-Hodgkin's Lymphoma who will receive an anti-CD20~     monoclonal antibody treatment during the induction phase of their treatment. Throughout the~     study, patients will have four blood draws at specified time points throughout the study. The~     initial blood draw will be analysed test patients for Cytomegalovirus and conduct a g-NK cell~     analysis. The final three blood draws will be conducted to analyse the g-NK cells at~     specified time points. The objectives of this study are to: 1) characterize the frequency of~     CMV (+) and g-NK (+) individuals in the B-NHL and B-CLL populations, 2) Determine changes in~     circulating g-NK cells during and after anti-CD20 monoclonal antibody containing remission~     induction chemotherapy and 3) Evaluate whether the presence of g-NK cells improve the outcome~     of anti-CD20 monoclonal antibody containing remission induction treatment of patients with~     B-NHL or B-CLL.~   "
11413|NCT03417401|"~     This phase Ib study investigates the safety and efficacy of performing a retinal vein~     cannulation with recombinant tissue Plasminogen Activator infusion into a retinal vein with~     the help of an updated dedicated surgical stabiliser for the treatment of central retinal~     vein occlusion.~   "
11414|NCT03417388|"~     The Ischemia-IMT (Ischemia-Intensive Medical Treatment Reduces Events in Women with~     Non-Obstructive CAD), subtitle: Women's Ischemia Trial to Reduce Events in Non-Obstructive~     CAD (WARRIOR) trial is a multicenter, prospective, randomized, blinded outcome evaluation~     (PROBE design) evaluating intensive statin/ACE-I (or ARB)/aspirin treatment (IMT) vs. usual~     care (UC) in 4,422 symptomatic women patients with symptoms and/or signs of ischemia but no~     obstructive CAD. The hypothesis is that IMT will reduce major adverse coronary events (MACE)~     20% vs. UC. The primary outcome is first occurrence of MACE as death, nonfatal MI, nonfatal~     stroke/transient ischemic attack (TIA) or hospitalization for heart failure or angina.~     Secondary outcomes include quality of life, time to return to duty/work, health resource~     consumption, angina, cardiovascular (CV) death and primary outcome components. Events will be~     adjudicated by an experienced Clinical Events Committee (CEC). Follow-up will be 3-years~     using 50 sites: primarily VA and Active Duty Military Hospitals/Clinics and a National~     Patient-Centered Clinical Research Network (PCORnet) clinical data research network~     (CDRN)(OneFlorida Consortium).~      This study is being conducted to determine whether intensive medication treatment to modify~     risk factors and vascular function in women patients with coronary arteries showing no flow~     limit obstruction but with cardiac symptoms (i.e., chest pain, shortness of breath) will~     reduce the patient's likelihood of dying, having a heart attack, stroke/TIA or being~     hospitalized for cardiac reasons. The results will provide evidence data necessary to inform~     future guidelines regarding how best to treat this growing population of patients, and~     ultimately improve the patient's cardiac health and quality of life and reduce health-care~     costs.~   "
11448|NCT03416946|"~     To determine if the use of patient-specific custom cutting blocks for implantation of total~     knee components results in improved limb alignment and component positioning compared to~     regular instrumentation.~   "
11471|NCT03416647|"~     Superior Mesenteric Artery Syndrome (SMAS) is a rare cause of duodenal obstruction, that~     should be suspected in cases of chronic, refractory upper digestive symptoms. Between 2008~     and 2016, 39 consecutive patients with chronic gastrointestinal symptoms and a diagnosis of~     SMAS were prospectively included in the study, in order to describe their demographic,~     clinical and outcome features. All patients underwent duodenojejunostomy.~   "
11415|NCT03417375|"~     The purpose of this study is to histologically and radiographically evaluate the maxillary~     sinus bone volume and density, with reference to percentage of vital bone present, after four~     months of grafting with either Osteocel or a cortical-cancellous allograft.~        1. To assess the quality and quantity of the maxillary sinus bone prior to the placement of~          dental implants and subsequent restorations, approximately 20 patients will be randomly~          assigned to receive an augmentation of the maxillary sinus region using either Osteocel~          or a cortical-cancellous allograft.~        2. With the use of pre-operative and four months post-operative CBCT radiography, the~          maxillary sinus bone density will be assessed and compared between the individuals~          receiving Osteocel and the individuals receiving conventional cortical-cancellous~          allograft material.~        3. Histomorphometric analysis will be used to assess, compare and contrast the quality and~          the quantity of the new vital bone cells generated when using these different graft~          materials~   "
11416|NCT03417362|"~     The majority of abortions in the United Kingdom (UK) are performed before 9 weeks (63 days)~     gestation using a method known as Early Medical Abortion (EMA). EMA involves an assessment~     visit and provision of two types of medication .~      The assessment visit usually involves Ultrasound to confirm gestation, detailed personal~     history, safeguarding assessment and contraception planning, before arranging treatment and~     follow up.~      The process is long and lots of information is given to women attending the service. In NHS~     Lothian (National Health Service, Lothian Health Board), the average appointment length for~     combined assessment and provision of the first part of treatment is 3 hours.~      Despite how common abortion is ( 1 in 3), many women presenting for abortion care are not~     aware of what the procedure will involve. This may in part to the social stigma surrounding~     abortion and unintended pregnancy in general. This stigma can in turn result in feelings of~     anxiety and shame about the decision to terminate a pregnancy.~      There is evidence that short videos shown to patients prior to abortion or contraception~     consultations can improve their ability to recall information and can make them feel more~     confident about the procedure.~      Additionally, abortion care providers have found patients who have seen videos to be better~     prepared and informed and this allows consultations to progress more easily and allow greater~     time for discussion of contraceptive methods.~      We have prepared a video approximately 3 minutes in length to provide information about EMA.~     It summarises the process described above using simple language and animated characters. The~     video has been translated into French, Portuguese and Swedish and has been adapted to reflect~     subtle differences in practice and law in these countries. We have partners in services in~     these three countries who will be conducting the trial there in accordance with this protocol~     and their own local ethics and clinical governance requirements.~   "
11417|NCT03417349|"~     Sesame is a European, multi-center, single arm, prospective, observational registry.~      Sesame aims to demonstrate that use of SOFIA™/SOFIA™ PLUS catheter for direct aspiration as a~     first line treatment technique is fast, safe and effective in patients suffering an Acute~     Ischemic Stroke when assessed at 24 hours, discharge and 90 days after treatment. 250~     patients will be enrolled. All patients will be followed for 90 days or until death.~   "
11418|NCT03417336|"~     The standard treatment of high-risk prostatic adenocarcinoma is based on pelvic-prostatic~     external radiotherapy combined with concomitant and adjunctive hormone therapy for a total of~     3 years.~      Prostatic stereotactic radiotherapy in 5 sessions is a therapeutic option currently delivered~     and described in multiple cohorts of patients with a tolerance comparable to normo-fractional~     treatments. This therapeutic scheme makes it possible to deliver a higher equivalent~     biological dose than during a treatment carried out with a conventional fractionation.~      The results with a follow-up of 9 years are extremely encouraging and do not show any excess~     toxicity compared to other irradiation techniques. They confirm that urinary and digestive~     toxicities are acceptable. All these studies did not involve pelvic irradiation. Several~     trials have also demonstrated the feasibility of normofractionated pelvic irradiation~     associated with hypofractionated prostatic irradiation using an integrated boost technique.~      The primary objective is to evaluate, for localized high-risk prostate cancers (unfavorable~     intermediate or high risk), the rate of digestive and urinary toxicity cumulated at 3 months~     of the association of a pelvi-prostatic irradiation contracted in 5 sessions, with:To~     evaluate, for localized high-risk prostate cancers (unfavorable intermediate or high risk),~     the rate of digestive and urinary toxicity cumulated at 3 months of the association of a~     pelvi-prostatic irradiation contracted in 5 sessions, with:~        -  a prostatic boost in brachytherapy with high dose rate (HDR) or~        -  an integrated boost in stereotaxis (in case of contraindication to brachytherapy)~   "
11419|NCT03417323|"~     The study address two main topics:~        1. The effect of compression garment on whole-body electromyostimulation (WB-EMS) induced~          muscle soreness in young adults~        2. The repeated bout effect of one intense session of WB-EMS as determined by various~          regeneration parameters~   "
11420|NCT03417310|"~     This study will use a new H joystick for reduction on patients with femur fractures to~     investigate the reduction time, operating time and bone healing status for the evaluation of~     the clinical application benefits of this joystick.~   "
11421|NCT03417297|"~     The purpose of this study is to assess the safety and feasibility of Magnetic Resonance~     Imaging-guided focused ultrasound (MRgFUS) in patients with epilepsy whose medicines are not~     working well. The ExAblate transcranial system is the name of the device that will be used to~     create and send ultrasound waves through the scalp and skull precisely to a small structure~     located in the center of the brain. This structure is known as the Anterior Nucleus, and is~     an important region in the brain that may cause the seizures. Safety will be measured by~     recording and analyzing any adverse effects that may occur from the day of the experimental~     surgery through 12 months following the surgery.~   "
11422|NCT03417284|"~     The goal of this clinical research study is to find the recommended dose level and dosing~     schedule of Evomela that can help prevent multiple myeloma from coming back in patients who~     are receiving an autologous stem cell transplant. The safety of using this drug before a~     transplant will also be studied.~      This is an investigational study. Evomela is FDA approved and commercially available for use~     before stem cell transplants. It is investigational to compare different dosing schedules of~     the drug and to use a higher dose of Evomela than the FDA approved dose.~      The study doctor can describe how Evomela is designed to work.~      Up to 60 participants will be enrolled in this study. All will take part at MD Anderson.~   "
11423|NCT03417271|"~     The aim of this investigation is to explore the effect of reducing conventional pulse width~     of stimulation on known adverse effects of Subthalamic nucleus Deep Brain Stimulation (STN~     DBS) treatment such as; slurring of speech, gait impairment, and unsteadiness. This~     investigation is designed such that each of 16 patients (who have all had chronically~     implanted DBS systems), will be assessed using conventional (DBS-60µs) and short (DBS-30µs)~     pulse width DBS, in a randomised order.~   "
11424|NCT03417258|"~     INTRODUCTION: The data obtained by experimental studies about the influence of phytoestrogens~     on colorectal cancer (CRC) have been very promising. On the other hand, clinical trials have~     produced conflicting results. The literature suggests that some subclasses of phytoestrogens~     may have protective effects against CRC and colon adenomas, but most of these results come~     from population studies based on the dietary intake of phytoestrogens. On these premises, it~     is possible to hypothesize that the variability of the data reported in the literature may be~     due to the fact that the real absorption of phytoestrogens (by assessing their concentration~     in the serum or urine) and/or the ability of the single individual of producing equol was not~     evaluated.~      PURPOSE: In the present study, the association between the phytoestrogens intake and the~     prevalence of colon adenomas was evaluated not only on the basis of the simply dietary intake~     but also on the measurement their intestinal absorption. Moreover, a specific evaluation of~     equol production by the intestinal flora was performed. Finally, intestinal bacteria involved~     in equol production were evaluated.~   "
11425|NCT03417245|"~     The purpose of this study is to determine the frequency of bleeding episodes in patients~     receiving fitusiran as prophylactic treatment of hemophilia compared with patients who are~     assigned to continue with their regular medication. In addition, the study will assess~     safety, quality of life, pharmacodynamics (PD), and pharmacokinetics (PK).~   "
11426|NCT03417232|"~     Aim: to evaluate the possible benefit on wound healing and flap stability of periosteum~     inclusion, comparing a split-full-split thickness flap elevation versus a split thickness~     approach performed during CAF for the treatment of isolated-type gingival recessions in the~     upper jaw.~      Material and Methods: forty patients were randomized, 20 were treated with split-full-split~     (test group) and 20 with a split approach (control group). Analyzed parameters at 1 year~     were: CRC, percentage of Recession Coverage (RC), Keratinized tissue (KT) gain,~     patient-related outcome measurements.~   "
11427|NCT03417219|"~     To address the high burden of caring for a Veteran with dementia, the investigators propose~     to study the effect of a low-cost, rehabilitative intervention for family caregivers of~     Veterans with dementia. The investigators' novel approach will use mobile media technology~     that can reach caregivers in rural areas who do not have easy access to major VA medical~     centers. If this rehabilitative intervention proves successful, it may represent an approach~     to Veteran and family-centered dementia care that can be used throughout VA with low staff,~     resource, and cost burdens.~   "
11428|NCT03417206|"~     The aim of this randomized trial is to assess the utility of Pupillary Dilatation Reflex~     (PRD) for monitoring pain perception intraoperatively and its influence on intraoperative~     blood loss, quality of surgical field using Boezaart Bleeding Scale (BBS) in patients~     undergoing functional sinus surgery (FESS) under total intravenous anaesthesia using propofol~     or volatile anaesthesia using sevoflurane or desflurane~   "
11429|NCT03417193|"~     This study compares the intraoperative opioid free anesthesia approach in multilevel spine~     posterior instrumentation surgery to a conventional opioid-based anesthesia. Half of~     participants will receive opioid free anesthesia with dexmedetomidine, lidocaine and ketamine~     while the other half will receive opioid based anesthesia with fentanyl, remi-fentanyl and~     ketamine~   "
11430|NCT03417180|"~     The aim of this randomized trial is to assess the utility of Surgical Pleth Index (SPI) for~     monitoring pain perception intraoperatively and its influence on intraoperative blood loss,~     quality of surgical field using Boezaart Bleeding Scale (BBS) in patients undergoing~     functional sinus surgery (FESS) under total intravenous anaesthesia using propofol or~     volatile anaesthesia using sevoflurane or desflurane~   "
11431|NCT03417167|"~     Synovial biopsies are now routinely performed both in research and in clinical practice. The~     developments of ultrasound (US) and of US-guided needle biopsies devices have facilitated~     their use and tolerance by the patients. However, their interest in clinical practice in the~     context of an undifferentiated arthritis remains debated.~   "
11432|NCT03417154|"~     This is a phase II trial of nivolumab and low dose cyclophosphamide (CTX) when given in~     combination to patients with relapsed/refractory acute myeloid leukemia (AML) and higher-risk~     myelodysplastic syndrome (MDS) who are not eligible for or decline hematopoietic stem cell~     transplant. It includes a randomized pilot sub-study during stage 1.~   "
11433|NCT03417141|"~     The primary objective of this study is to assess the potential effectiveness of once daily~     application of Valchlor in decreasing disease activity in patients with Lichen Planopilaris.~     The primary measurement of efficacy will be with the Lichen Planopilaris Activity Index~     (LPPAI) before and after 6 months of treatment. Secondary measures of efficacy will be the~     mean follicular density, Physician Global assessment (PGA) score, and the Dermatology Quality~     of Life Index (DQLI) score before and after six months of therapy.~   "
11434|NCT03417128|"~     The outlook of a community-based intervention targeting nutrition and lifestyle behaviour~     modification among adults with metabolic syndrome (MetS) has not been fully explored. The~     primary aim of this study (PERSUADE) is to evaluate the effect of the peer support~     intervention on the clinical outcomes MetS components followed by improvements in the~     participants' dietary practices, physical activity levels and lifestyle behaviours. The~     program constructed using information obtained from the published clinical and dietary~     guideline in Malaysia.~   "
11435|NCT03417115|"~     The purpose of the project is to set up a national, prospective, longitudinal, multicenter~     cohort study with associated satellites, a tumor registry platform, to document uniform data~     on characteristics, molecular diagnostics, treatment and course of disease, to collect~     patient-reported outcomes and to establish a decentralized biobank for patients with advanced~     breast cancer in Germany.~   "
11436|NCT03417102|"~     The purpose of this study is to determine the frequency of bleeding episodes in patients~     receiving fitusiran as prophylactic treatment of hemophilia compared with patients who are~     assigned to continue with their regular medication. In addition, the study will assess~     safety, quality of life, pharmacodynamics (PD), and pharmacokinetics (PK).~   "
11437|NCT03417089|"~     The falciform ligament is hanging down in the upper abdomen and usually impede the work~     during laparoscopic upper GIT surgery, especially in obese patient, so the aim of this study~     is to evaluate the impact of routine suspension of falciform ligament during mini gastric~     bypass, which is advanced laparoscopic procedure, by comparing the outcomes in 2 groups of~     patient in the fist group the investigators will routinely suspend the falciform ligament and~     the other group the investigators will working without suspension~   "
11439|NCT03417063|"~     Stroke has become the leading cause of death in China. It has been shown that intracranial~     artery stenosis (ICAS) plays a key role in Chinese stroke patients. Although most of stenotic~     diseases in intracranial arteries are atherosclerotic, a substantial number of other vascular~     diseases, such as dissection, arteritis, moyamoya disease, and reversible cerebral~     vasoconstriction syndrome (RCVS), can also lead to intracranial artery luminal narrowing. It~     is challenging to differentiate the etiologies of ICAS relying on measuring luminal narrowing~     by angiographical approaches. In addition, the progression of intracranial atherosclerotic~     disease (ICAD) has been demonstrated to be highly associated with the risk of ischemic~     cerebrovascular events. However, the influence factors for ICAD progression remains unclear.~      High-resolution magnetic resonance imaging (HR-MRI) has been widely used to assess ICAS~     diseases. The different etiologies of ICAS are differentiable by MR-MRI according to the~     features of location, shape, signal pattern, remodeling, and contrast enhancement.~     Investigators have proved that HR-MRI is a reproducible technique that may be reliably~     utilized to monitor the changes of ICAD during natural follow-up or medical treatment.~      The ICASMAP (Intracranial Artery Stenosis MR Imaging: Aetiology and Progression) is a~     prospective, cross-sectional, observational, and multicenter study. The objectives of ICASMAP~     are to determine: 1) the spectrum of etiology of ICAS in stroke patients; and 2) the~     influence factors for progression of ICAD. A total of 300 patients with symptomatic stenotic~     disease in intracranial arteries (stenosis range: 30%-99%) will be recruited within two weeks~     after symptom onset from 18 different hospitals across Beijing-Tianjin-Hebei region in China~     within 1 year. All the patients will undergo HR-MRI for intracranial arteries at baseline,~     one-year, and two-years. The clinical risk factors will be collected and blood draw will be~     conducted. The ICASMAP study may help to improve the precise diagnosis and intervention of~     ICAS and stroke prevention.~   "
11440|NCT03417050|"~     An investigator-driven, retrospective study to compare long-term survival-data (10-year~     follow-up) of patients with coronary artery disease (CAD), previously enrolled in the SYNTAX~     trial, who were randomized to percutaneous coronary intervention (PCI) using a paclitaxel~     (TAXUS) drug-eluting-stent (DES) or coronary artery bypass grafting (CABG).~   "
11441|NCT03417037|"~     This is a study of experimental medication BMS-986205 given with Nivolumab with or without~     chemotherapy compared to chemotherapy in participants with previously untreated stage IV or~     recurrent non-small cell lung cancer.~   "
11442|NCT03417024|"~     The contribution of automated breast ultrasound (ABUS) to the screening pathway for breast~     cancer is not fully understood. This prospective study aims to collect longitudinal data in~     women with dense breasts undergoing ABUS as a supplement to digital breast tomosynthesis~     (DBT). The data are intended for use in future research on the value and effectiveness of~     ABUS in routine clinical care.~      Data will be collected from eligible women who have been prescribed or have completed DBT and~     ABUS, screening within a 30-day window. Radiologist evaluations and, when performed, outcomes~     of biopsy and/or laboratory testing will be recorded. Subjects will be followed for breast~     cancer status and results of any diagnostic breast exams and/or treatment.~   "
11443|NCT03417011|"~     Prospective, single-arm, multi-center, interventional post-market study. After signing~     informed consent, eligible subjects will be implanted with the CE marked Evolut™ PRO system.~      The investigation purpose is to evaluate the acute and long term clinical performance and~     safety of Evolut™ PRO in a routine hospital setting in patients with symptomatic native~     aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve~     failure necessitating valve replacement within the approved intended use in local geography.~   "
11444|NCT03416998|"~     Background: Photobiomodulation with low-level laser therapy (LLLT) has been widely used in~     clinical practice for diverse purposes, such as modulation of the inflammatory process,~     acceleration of the tissue repair process, pain relief and the enhancement of post-exercise~     recovery. Studies have demonstrated a beneficial interaction between photobiomodulation and~     the production of creatine kinase, with a reduction in the release of this marker of muscle~     damage when laser and/or LEDs is administered prior to high-intensity physical activity. The~     aim of the proposed study is to determine the influence of pre-exercise phototherapy on~     post-exercise muscle recovery.~      Methods: A randomized, cross-over, sham-controlled, double-blind, clinical trial is proposed.~     The participants will be healthy professional soccer players aged 15 to 20 years from the~     same team with a body mass index within the ideal range (20 to 25 kg/m2) and no history of~     lower limb musculoskeletal injuries or surgery or back surgery in the previous six months.~     The athletes will be allocated to two groups based on the previously calculated sample size~     and will be blinded to allocation. Creatine kinase will be measured and the subjective~     perception of fatigue will be determined for each participant. The volunteers will then be~     randomly allocated to Group A, which will receive active phototherapy, and Group B, which~     will receive sham phototherapy. The athletes will undergo reevaluations immediately after as~     well as 48 hours after a football match. The data will be submitted to statistical analysis~     and the level of significance will be set to 5%.~   "
11445|NCT03416985|"~     It is well accepted that the greatest contributor to the health of the periodontium and~     dentition is regular and thorough dental plaque removal, typically by means of adequate~     toothbrushing. Although patients are typically informed about the risks of substandard oral~     hygiene and the contributing factors in oral/dental disease by dental professionals, research~     has shown that an undesirably high proportion of adults find thorough toothbrushing with a~     standard manual toothbrush to achieve a plaque-free state challenging, as evidenced by high~     worldwide levels of gingivitis and/or periodontitis.~   "
11446|NCT03416972|"~     Lung cancer is the most common cause of cancer death in Canada. For approximately 30% of~     patients that present with locally-advanced non-small cell lung cancer (NSCLC), the standard~     treatment is curative-intent concurrent chemoradiotherapy. Outcomes remain poor, with 5-year~     survival of only 20%. Despite the long-held belief that higher radiation doses lead to~     improved overall survival (OS), the landmark randomized trial (RTOG 0617) showed the~     opposite. The investigators hypothesize that the inferior survival observed may be due to~     unexpected heart toxicity as secondary analysis revealed that the heart dose was a strong~     predictor of inferior OS. Up to now, change in heart function is typically detected~     histologically, requiring autopsy tissue. Therefore, a non-invasive marker of early heart~     damage is required. Hybrid PET-MRI has become available in Canada only recently. The ability~     to simultaneously perform metabolic imaging with functional and tissue imaging allows for~     novel assessment of heart toxicity. The primary objective is to examine the utility of hybrid~     PET-MRI and DCE-CT to assess acute changes in heart function and to measure inflammation~     before, and six weeks after NSCLC radiotherapy. A pilot of 20 patients with Stage I-III NSCLC~     will be enrolled. The findings of this study will aid in the design of new studies to~     reassess dose escalation for locally advanced NSCLC while limiting the risk of heart~     toxicity. FDG PET will be used to simultaneously assess both cardiac inflammation and tumour~     response. Quantitative DCE-CT will also be used to measure ventilation and perfusion changes~     in the normal lung and tumour after radiotherapy, providing image data that can~     comprehensively assess both tumour response and potential toxicity in both the heart and~     lungs. Such information is crucial in understanding the disease and its response to~     treatment. This data will also aid in the design of radiation techniques that spare the heart~     in other patients with any thoracic malignancies, including breast cancer, lymphoma, and~     esophageal cancer.~   "
11447|NCT03416959|"~     The aims of this study are to collect prospective data on the natural history of bone~     metastases (BMs) and skeleta related events (SREs),~   "
11449|NCT03416933|"~     BRAF V600-mutant metastatic melanoma are commonly treated using a combination of anti-BRAF~     and anti-MEK tyrosine kinase inhibitors (TKIs). The OPTIMEL trial aims to study the interest~     of therapeutic drug monitoring (TDM) of TKIs and circulating tumor DNA (ctDNA) detected in~     plasma of patients with metastatic melanoma for disease monitoring. 35 patients with~     metastatic melanoma and treated with dabrafenib and trametinib will be enrolled in this~     trial. Blood samples will be collected for the determination of TKIs concentration and ctDNA~     detection.~   "
11450|NCT03416920|"~     The investigators aim to evaluate Wellframe, a patient engagement platform that includes a~     mobile phone application for patients, for its impact on supporting patients who have~     undergone a percutaneous coronary intervention. The patient mobile app has articles about~     cardiovascular disease and other health related topics, patient-reported outcomes surveys,~     physical activity tracking, reminders for medications and upcoming appointments, and two-way~     communication with a Wellframe Health Advocate. The Wellframe Health Advocate encourages~     patients to achieve their health goals and stay engaged in their health. The feasibility of~     onboarding patients to the app and the clinical efficacy of the platform will be evaluated.~   "
11451|NCT03416907|"~     This study will test whether different formats of medical informed consent documents can help~     improve understanding and confidence in decision-making for clinical trials. The study will~     be primarily run through an online survey.~   "
11452|NCT03416894|"~     This is a phase I, non-blinded, non-randomized, pilot trial for safety and efficacy of deep~     brain stimulation for PTSD. A substantial number of individuals continue to experience PTSD~     symptoms despite appropriate medical treatment. In psychotherapy-based studies, over 30% of~     patients that completed a full course of treatment continue to meet criteria for PTSD.~     Response rates to treatment with SSRIs are usually no higher than 60%. This study would be~     the first exploration of a surgical therapy for refractory PTSD. The subgenual cingulate~     plays a role in mechanisms of this disorders and has been successfully targeted with DBS for~     the treatment of depression. The development of a therapy that targets brain structures known~     to play a role in this disease would be a substantial step forward in the treatment and~     understanding of these conditions.~   "
11453|NCT03416881|"~     Drug interactions between antiretroviral drugs and concomitants drugs and between~     antiretroviral need to be studied HIV-population is ageing. The referential of interactions~     is the Liverpool base.~   "
11454|NCT03416868|"~     Note that this is the second half of a study under the same IRB and NIH grant. This second~     study will enroll patients with nodules and those with muscle tension dysphonia. These two~     groups will receive ambulatory voice biofeedback throughout 6 weeks of voice therapy. The~     targeted objective voice measure during biofeedback will be individually tailored with the~     goal of increased percentage compliance.~   "
11455|NCT03416855|"~     The purpose of this study is to collect information about safety and effectiveness of~     Ryzodeg® FlexTouch® in participants with diabetes mellitus requiring insulin therapy under~     routine clinical practice conditions with the aim of identifying or quantifying a safety~     hazard, early detection of unknown safety problems. Participants will attend the~     clinic/hospital/medical institution according to usual practice and receive medical care, as~     agreed with the study doctor.~   "
11456|NCT03416842|"~     Repetitious motor therapy has been shown to yield the greatest improvement in motor function~     in those who suffer hemiplegia because of a neurological impairment. However, motor therapy~     remains largely clinically based due to the absence of quantitative home-based therapy~     technology or equipment. With the current lack of accountability, patient adherence to home~     exercise physical therapy programs is estimated to be as low as 35%. In response, some~     companies have extended the applications of their motion capture devices to be used for~     home-based physical therapy. However, the technologies often have not passed their initial~     stages of development. In contrast, a company named 4D Motion is actively working alongside~     the Restorative Neurology Clinic at Burke Medical Research Institute to develop a motion~     capture system tailored to the motor rehabilitation of hemiplegic stroke patients. This~     device is driven by a user's active range of motion and does not impart electrical or~     mechanical stimulation to the user. The device does not force the user beyond their active~     range of motion and does not apply resistance to motion that limits the user's capability.~     The 4D Motion capture system is only used to record what the patient is doing and to promote~     adherence to their prescribed physical therapy plan.~   "
11457|NCT03416829|"~     This first study will enroll 3 groups of patients with vocal fold nodules that will receive~     different schedules of ambulatory voice biofeedback (100% frequency feedback, 25% frequency~     feedback, summary feedback) to avoid their upper 15th percentile of vocal loudness.~   "
11458|NCT03416816|"~     This is a Phase 1, open label, multi-center study of orally administered DSP-0337 in adult~     subjects with advance solid tumors that are refractory to standard treatment, or for whom no~     effective therapy exists.~   "
11459|NCT03416803|"~     Objectives:~        1. To further validate the predictive efficacy of our established microRNA prediction model~          of HCC lymph node metastasis.~        2. To establish a precise therapeutic mode of prophylactic radiation therapy in high-risk~          patients with HCC with lymph node metastasis under the guidance of a microRNA prediction~          model.~   "
11460|NCT03416790|"~     IMPAACT 2015 is a cross-sectional, exploratory study that will investigate the central~     nervous system (CNS) reservoir in perinatally HIV-infected adolescents and young adults on~     effective antiretroviral therapy with neurocognitive impairment. The study will assess the~     frequency with which HIV is detected in the cerebral spinal fluid (CSF) in this population~     and assess whether detectable HIV in the CSF correlates with markers of inflammation and~     neuronal injury. Findings from this study will advance understanding of the role of the CNS~     in HIV-1 persistence and its implications for future HIV-1 remission research.~   "
11469|NCT03416673|"~     34 patients with Miller class III will be included in this study, where 17 participants will~     be treated with connective tissue graft with coronally advanced flap (control group) and 17~     participants will be treated with a papillary extended connective tissue graft with coronally~     advanced flap (test group) and followed up for 6 months.~   "
11470|NCT03416660|"~     This study aims to compare effectiveness of different densities of carbon dioxide fractional~     laser in the treatment of postburn scar.~   "
11461|NCT03416777|"~     Colorectal cancer (CRC) is strongly affected by diet, with red and processed meat increasing~     risk. To understand the role of microbiome in this phenomenon and to identify specific~     microbiome/metabolomics profiles associated with CRC risk, will be studied: 1) healthy~     volunteers fed for 3 months with: a high-CRC risk diet (meat-based MBD), a normalized CRC~     risk diet (MBD plus alpha-tocopherol, MBD-T), a low-CRC risk diet (pesco-vegetarian, PVD). At~     the beginning and at the end of the intervention, gut microbiome profiles (metagenomics and~     metabolomics), and CRC biomarkers (genotoxicity, cytotoxicity, peroxidation in faecal water;~     lipid/glycemic indexes, inflammatory cytokines, oxidative stress), 2) Colon carcinogenesis:~     the same diets will be fed (3 months) to carcinogen-induced rats or to Pirc rats, mutated in~     Apc, the key gene in CRC; faecal microbiome profiles, will be correlated to carcinogenesis~     measuring preneoplastic lesions, colon tumours, and faecal and blood CRC biomarkers as in~     humans; 3) To further elucidate the mechanisms underlying the effect of different microbiomes~     in determining CRC risk, faeces from rats fed the experimental diets will be transplanted~     into carcinogen-induced germ-free rats, measuring how microbiome changes correlate with~     metabolome and disease outcomes. The results will provide fundamental insight in the role of~     microbiome in determining the effect of the diet, in particular red/processed meat intake, on~     CRC risk~   "
11462|NCT03416764|"~     The current study aims to explore the relationship between estrogen-related plasticity in~     limbic circuits and response to amygdala-electrical-fingerprint focused neurofeedback~     (EFP-NF) among women with a history of childhood sexual abuse (CSA). Treatment groups will~     differ by phase of cycle where treatment is given, and effects are expected to differ based~     on estrogen levels during treatment. Greater effects are expected in the high-estrogen phase~     treated group on both symptoms and neural changes.~   "
11463|NCT03416751|"~     There is an epidemic of alcohol use disorder in the US. Alcoholism is an epidemic that spans~     all ages and socio-economic strata, which has a major impact on healthcare expenditure.~     Alcohol-associated liver disease can take the form of mild fatty liver, chronic liver disease~     including cirrhosis and a very acute active form known as alcoholic hepatitis. However, most~     patients with alcohol abuse issues with cirrhosis do not develop alcoholic hepatitis and are~     not willing to quit drinking. These patients are neither liver transplant candidates due to~     their drinking nor have any recourse to therapies directed towards the liver as is the case~     with alcoholic hepatitis. This is very large proportion of cirrhotic patients who do not have~     many therapeutic options.~      Prior studies have demonstrated that these patients have an altered gut-liver axis which is~     exacerbated by dysbiosis and a higher production of potentially toxic secondary bile acids.~     These secondary bile acids in turn have the potential to worsen the already impaired gut~     barrier in these patients, creating a vicious cycle of inflammation and further liver injury~     that is led by the altered microbial composition. A gut-based strategy that has the~     capability of resetting this dysbiosis could help in the amelioration of this inflammatory~     load and improve the prognosis of these patients.~   "
11464|NCT03416738|"~     Stroke is the leading cause of adult disability in the United States, and aphasia is common~     following a stroke to the left hemisphere of the brain. Aphasia therapy can improve aphasia~     recover; however, very little is known about how different patients respond to different~     types of treatments.~      The purpose of this study is to understand how the following factors influence an~     individual's response to aphasia treatment: 1) biographical factors (e.g., age, education,~     gender), 2) post-stroke cognitive/linguistic abilities and learning potential, and 3) the~     location and extent of post-stroke brain damage. We are also interested in understanding the~     kinds of treatment materials that should be emphasized in speech/language treatment.~      Overall, the goal of the current research is to inform the clinical management of post-stroke~     aphasia by identifying factors that can predict how an individual will respond to different~     treatment methods.~   "
11465|NCT03416725|"~     Tympanoplasty is the surgical operation performed for the reconstruction of the eardrum~     and/or the ossicles. Tympanoplasty is classified into five different types, originally~     described by Horst Ludwig Wullstein. 1,2 Type 1 involves repair of the tympanic membrane~     alone, when the middle ear is normal. A type 1 tympanoplasty is synonymous to myringoplasty,~     Type 2 involves repair of the tympanic membrane and middle ear in spite of slight defects in~     the middle ear ossicles, Type 3 when mallus and incus are absent graft place directly on~     stapes head., Type 4 describes a repair when the stapes foot plate is movable, but the crura~     are missing. The resulting middle ear will only consist of the Eustachian tube and~     hypotympanum, Type 5 is a repair involving a fixed stapes footplate.~      There are various prognostic factors reported in the literature that may influence the~     surgical success of tympanoplasty.~   "
11466|NCT03416712|"~     This will be a randomized control trial of 800 children admitted to the Pediatric Hospital~     Medicine service at Texas Children's Hospital. Each eligible participant will give informed~     consent prior to enrollment. Study participants will be randomized into an intervention (400~     participants) or control group (400 participants). The intervention group will receive a~     survey (WE CARE HOUSTON) that has been designed to assess family need for community resources~     that address the SDH (such as food insecurity, housing insecurity, etc.). The intervention~     group will receive referrals to community resources based on their responses to the WE CARE~     HOUSTON survey.~   "
11467|NCT03416699|"~     Total mesorectal excision (TME) is the gold standard procedure for treating rectal cancer.~     However, in patients with obesity, prostate hypertrophy, low located tumor or/and pelvic~     stenosis, the traditional laparoscopic or open surgery is not easy to conduct. Transanal~     total mesorectal excision (TaTME) might serve as a better procedure for these patients, for~     it might ease the dissection of the low mesorectum. So far, several studies have showed the~     promising results of TaTME, but the multi-center data in China is still lacking. This~     nationwide registry study included more than 30 Chinese hospitals, aiming at obtaining data~     on the safety and efficacy of this procedure in Chinese patients with rectal cancer and~     encouraging future research in this field.~   "
11468|NCT03416686|"~     Radiofrequency (RF) could be technically feasible and effective in the treatment of lymph~     node metastases of differentiated thyroid cancer. It could constitute a minimally invasive~     and feasible therapeutic alternative in ambulatory, allowing a reduction of the tumoral~     volume sufficient to limit the symptoms even to induce a tumor remission, a normalization of~     the tumoral markers and a better quality of life.~      The aim of this study is to evaluate the anti-tumor echographic efficacy at 12 months of~     radiofrequency on lymph node (LN) metastasis of thyroid cancer~   "
11472|NCT03416634|"~     Implementation of physical activity promotion in routine health care delivery is low because~     of multiple barriers including insufficient health system support, care team coordination,~     and scarcity of community resources for referring patients and technology tools for~     sustaining lifestyle changes. This study is a pilot project to test the feasibility of~     implementing a physical activity promotion protocol, including routine evaluation of~     patient's physical activity levels and provision of educational material in the clinical~     workflow. Physically inactive adult patients with at least one documented cardiovascular~     disease risk factor will be invited to participate in physical activity intervention.~     Patients will be randomized to receive a wearable device or a smartphone app to objectively~     monitor their physical activity. Participants will be further randomized to receive automated~     motivational text messages, or a personalized motivational message, or no messages.~     Participants will be followed through the 12 week intervention period and an additional 12~     weeks with no intervention.~   "
11473|NCT03416621|"~     The purpose of this pilot study is to evaluate the feasibility, acceptability, and~     preliminary efficacy of an intervention to promote smoking cessation among light smokers.~   "
11474|NCT03416608|"~     This study in part of a larger cohort study (clinical trials ID number: NCT03375333) that~     examine the use of ultrasound in general practice.~      In the present study patient experiences, with use of ultrasound in the consultation at the~     general practitioners office, will be explored through a questionnaire.~   "
11475|NCT03416595|"~     The aim of the study is to examine the intervening effects of N1115 Probiotic Supplement~     (containing Junlebao Lp. N1115) on gut development in young children at the age of 6 month to~     3 years by the way of a randomised, double-blinded, parallel, placebo-controlled clinical~     trial, and to explore the change of intestinal microbiota composition and healthy condition~     after intervention.~   "
11476|NCT03416582|"~     This is a descriptive mixed method pilot study to determine the feasibility of a tailored~     nurse-delivered telephone intervention designed to impact mucositis symptom severity and~     prevent dehydration in lung cancer patients undergoing chemoradiation, therefore reducing~     overall symptom severity and improving quality of life. Secondary purposes for this study are~     to investigate if the nursing intervention can decrease lung cancer patients' unscheduled~     medical visits between chemoradiation treatments.~   "
11477|NCT03416569|"~     To test whether specific aspects of the attention-enhancing effects of nicotine may be~     mediated by down-stream activation of alpha1 adrenoceptors, the interaction of nicotine and~     the alpha1 adrenergic antagonist prazosin on cognitive task performance will be tested in~     human non-smokers. The effects of a low-dose nicotine patch vs. a placebo patch will be~     tested in the presence and absence of prazosin over 4 test sessions.~   "
11478|NCT03416556|"~     Background: Passive oscillatory mobilizations are often employed by physiotherapists to~     reduce shoulder pain and increase function. However, there is little data about the~     neurophysiological effects of these mobilizations.~      Objectives: To investigate the initial effects of an anteroposterior (AP) shoulder joint~     mobilization on measures of pain and function in overhead athletes with chronic shoulder~     pain.~   "
11479|NCT03416543|"~     First, this study will evaluate, in vitro, the cellular composition of the synovial fluid~     from patient with rheumatoid arthritis or gout.~      Then samples will be test with a new format of bispecific antibody targeting dendritic cells.~     The production of IL-10 will be the principal criteria of judgment. Production of IL-6 and~     IFN will be checked as well.~   "
11480|NCT03416530|"~     This is a multicenter, open-label, two arm, dose escalation, phase I study of oral ONC201 in~     pediatric patients with newly diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) and~     recurrent/refractory H3 K27M gliomas. Arm A will define the RP2D for single agent ONC201 in~     pediatric patients with glioma who are positive for the H3 K27M mutation (positive testing in~     CLIA laboratory) and have completed at least one line of prior therapy. This will allow for~     recurrent patients and also patients who have not yet recurred, but have completed radiation~     and will inevitably recur based on prior clinical experience and the literature. Arm B will~     define the RP2D for ONC201 in combination with radiation in pediatric patients with newly~     diagnosed DIPG.~   "
11481|NCT03416517|"~     The investigators explored the activity of anlotinib combined with irinotecan in patients~     with relapsed and metastatic Ewing Sarcoma.~   "
11482|NCT03416504|"~     The current study sought to translate laboratory research on learning and memory to better~     understand the mechanisms and methods for implementing exposure therapy for unwanted~     obsessional thoughts. Specifically, we compared the processes and the short- and long-term~     outcomes of: (a) gradual exposure (EXP-G), emphasizing hierarchical exposure completion,~     versus (b) variable exposure (EXP-V), emphasizing variability in exposure intensity.~   "
11483|NCT03416491|"~     This study aimed to evaluate the safety and efficacy of KW-136, an investigational~     anti-hepatitis C virus (HCV) drug, combined with sofosbuvir for treatment of Chinese adults~     chronically infected with HCV. Thirty (30) non-cirrhotic subjects were medicated with KW-136~     30 mg daily, 60 non-cirrhotic subjects with KW-136 60 mg daily, and 30 cirrhotic subjects~     with KW-136 60 mg daily; all the 120 subjects received sofosbuvir 400 mg daily. The treatment~     course lasted 12 successive weeks and thereafter all the study participants entered into a~     12-week treatment-free follow-up period.~   "
11484|NCT03416478|"~     This study is to evaluate circulating tumor DNA (ctDNA) as a predictive and surveillant~     method for tumor recurrence in stage II and III colorectal cancer (CRC).~   "
11485|NCT03416465|"~     The Purpose of MGPEC_ONCO is to see if patient consult their general practitioner during the~     management of their cancer, especially before hospitalization. The study concerns not planned~     hospitalizations in medicine service.~      Before leaving hospital, the patient completes the survey, other data are taken in patient~     record~   "
11525|NCT03415945|"~     In cardiac resynchronization therapy (CRT), biventricular pacing is performed by pacing the~     right ventricle (RV) and epicardium of the left ventricular (LV) postero-lateral wall. A~     significant proportion of apparently suitable patients fail to benefit from CRT. One of the~     problems of CRT is proper positioning and fixation of the LV pacing lead in the coronary~     vein. LV septal pacing may be a good alternative for BiV pacing in patients with an~     indication for CRT.~   "
11526|NCT03415932|"~     This prospective intervention study evaluates whether health education and basic body~     awareness training reduces health care consumption and improves movement quality among~     refugees in Sweden.~   "
11486|NCT03416452|"~     Background:~      Parkinson s disease (PD) is a neurologic disorder that causes slowness, tremor, rigidity, and~     imbalance. Gait impairment is also common. There are 2 substudies: (1) Physiology of Freezing~     and Gait; (2) Vibratory Cueing. Healthy participants can join only Substudy 1.~      Objective:~      To study gait disorders in PD. Also, to test the effect of specific interventions for gait in~     people with PD.~      Eligibility:~      People ages 18 and older who:~      Have PD with bilateral symptoms but can walk without a cane or walker~      Are healthy~      Design:~      Participants will be screened in Protocols 93-N-0202 and 01-N-0206.~      Both substudies include a physical exam and medical history.~      Substudy 1:~      Participants will have one 6-hour visit. They must wear a tank tops and shorts with tennis~     shoes during the visit. They will perform gait tasks. Markers placed on the skin will record~     movements. They will have an EEG: They will wear an electrode cap to record brain waves. They~     will wear special glasses to record eye movements. Participants with PD will hold their~     morning dose of PD drugs. They can choose to be admitted to the hospital the previous~     evening. Otherwise someone else or a taxi must bring them to the visit. They will first~     perform the study tasks off their drugs. Then they will take their drugs and repeat them.~      Substudy 2:~      Participants will have one 3-hour visit. A small vibratory device will be attached to their~     ankle. Reflective markers placed on the skin will record movements while they walk:~      Without the device~      With the device, but the vibrator off~      With the device, with the vibrator on~      With a magnet attached to the ankle~   "
11487|NCT03416439|"~     The investigators compared the effectiveness of a lifestyle intervention program carried out~     by trained professionals versus standard unstructured information on healthy lifestyle given~     by the family physicians in ameliorating the metabolic pattern of adults with multiple~     metabolic and inflammatory abnormalities.~   "
11488|NCT03416426|"~     Among consecutive 47 cryptogenic stroke patients who underwent PFO closure, a serial~     follow-up bubble contrast TEE at 3 and 9 months after the index procedure was completed in 38~     patients (81%, 46±10 years, 19 men). To evaluate the efficacy of PFO closure, the incidence~     of any- and significant residual shunt (≥moderate) was assessed.~   "
11489|NCT03416413|"~     This study will be comparing the treatment of varicose vein tributaries using either foam~     sclerotherapy or ambulatory phlebectomies. Patients will be randomised to having either~     ambulatory phlebectomy (group A) or foam sclerotherapy (group B) following treatment of their~     saphenous vein.~      The re-intervention rates, safety, patient experience as well as the cost effectiveness of~     each intervention will be assessed.~   "
11490|NCT03416400|"~     Human oocyte cryopreservation is routinely used for fertility preservation of women who will~     be exposed to gonadotoxic effect of cancer treatment. After ovarian stimulation, matured~     oocytes are vitrified. However, this strategy cannot always be used, particularly for~     hormone-sensitive cancer or when ovarian stimulation is not possible. An approach including~     immature oocytes and in vitro maturation (IVM) could be considered in these cases. While some~     qualitative analysis of oocytes vitrified before or after IVM suggest that vitrification~     should be performed after IVM, little is known about vitrification effects on actin and~     tubulin cytoskeleton and kinetic of maturation of human ovocytes.~      To answer to this question, Investigator performed quantitive analyses comparing matured~     oocytes from three different groups: vitrified before IVM or after IVM and non-vitrified~     oocytes. Non-vitrified matured oocytes were used as a control. Different parameters have been~     analysed during maturation and in matured oocytes.~   "
11491|NCT03416387|"~     Three-dimensional (3D) printing has gained popularity in medicine over the last decade. Once~     3D printers have become more affordable, the true strength of this technique has been~     recognized because of its ability to obtain anatomical models based on the unique~     characteristics of each patient. Liver resections are challenging operations because of the~     complex nature of the liver and venous anatomy within the liver, so 3D imaging is a promising~     new tool for surgical planning.~   "
11492|NCT03416374|"~     The purpose of this study is to investigate the efficacy and safety of long-term~     administration of the oral proteasome inhibitor ixazomib as part of ixazomib in combination~     with lenalidomide and dexamethasone (IRd) therapy in patients with relapsed and/or refractory~     multiple myeloma (RRMM) treated initially with an injectable proteasome inhibitor-based~     therapy.~   "
11493|NCT03416361|"~     VINDICATE 2 will be a randomised, placebo-controlled, parallel group, double-blind study of~     vitamin D versus placebo in otherwise optimally-managed patients with CHF due to LVSD and~     vitamin D deficiency (<50nmol/L). The intervention will be a daily dose of 4000IU (100µg) per~     day or matching placebo for a minimum of 2 years and a maximum of 4 years.~   "
11494|NCT03416348|"~     The objective is to establish an evidence base for a hyperhidrosis treatment algorithm in~     amputees. This project will address a problem that has troubled Service members, Veterans,~     and civilians with amputations for decades, impacting satisfaction with prosthetic use,~     residual limb skin health, and negatively affecting quality of life. Prior research in this~     area has been limited and insufficient. The Investigators are confident that improving the~     evaluation and treatment of residual limb hyperhidrosis will reduce the secondary health~     consequences of amputation and will lead to improved quality of life. This will be accomplish~     by completing the following specific aims.~      Aim 1: Test the validity of the Minor iodine-starch test in amputees. Hypothesis: The~     iodine-starch test is a valid diagnostic tool of hyperhidrosis and can be useful for the~     identification of focal areas of sweating on a residual limb Aim 2: Test the effectiveness of~     a prescription strength topical antiperspirant (Aluminum Chloride 20%) on hyperhidrosis of~     the residual limb.~      Hypothesis: Aluminum Chloride will be more effective at controlling sweating than placebo~   "
11495|NCT03416335|"~     This is a Phase 1, open label, multi-center study of intravenously administered DSP-0509 in~     adult subjects with advance solid tumors that are refractory to standard treatment.~   "
11527|NCT03415919|"~     To collect human tissue, blood, and fecal samples from patients suffering from Inflammatory~     Bowel Disease and Colorectal Cancer. The samples will be used to establish biomimetic human~     organ-on-a-chip technology, as well as study the role of the microbiome in the pathogenesis~     in human gastrointestinal diseases.~   "
11781|NCT03412604|"~     This study aims to implement an intervention based on multiple, individualized multifocal~     tACS stimulation sessions based on individual PET and MRI information in patients with~     amyloid-positive PET with the hope that this leads to microglia activation and decrease in~     cerebral amyloid and tau depositions in human patients with AD.~   "
11496|NCT03416322|"~     Introduction and objectives: The adenoma detection rate (ADR) has been investigated as a~     formal method in the evaluation of a trainee or resident physician. Several studies have~     suggested that water-assisted colonoscopy methods increase the ADR, especially in the right~     colon, when compared to air-insufflated methods alone. The objective of this study is to~     compare the adenoma detection rates between the techniques of the second frontal view~     examination and Underwater examination by residents, supervised by a senior endoscopist.~      Patients and methods: This is a prospective, comparative and randomized clinical trial. The~     patients referred to the Cancer Hospital of Barretos for colonoscopy, and who agreed with the~     study, were divided into two groups, one with the use of water and the other only with air~     insufflation. The primary endpoint of this study is to compare adenoma detection rate.~     Secondary outcomes were withdrawal time, proportion of intubation of the cecum, preparation~     of the colon, and number of previously performed colonoscopies in the ADR in both techniques.~   "
11497|NCT03416309|"~     The aim of the study is to investigate the possible correlation of plasma drug concentrations~     with Time To Positivity (TTP) in liquid culture in patients with active pulmonary multi~     sensitive TB in the first two weeks of treatment. Secondary aims are: the correlation between~     plasma drug concentrations and hepato/neuro toxicity; the impact of different allelic~     variants on PK data, toxicity and TTP in liquid culture; the feasibility of using dried~     blood/plasma spots to measure plasma concentrations of anti-TB drugs and determine genetic~     polymorphisms.~   "
11498|NCT03416296|"~     Placenta accreta occurs when the placental implantation is abnormal. The marked rise in~     incidence has been assumed the increasing prevalence of cesarean delivery in recent years.~   "
11499|NCT03416283|"~     A 3-arm randomized pilot trial aimed at comparing the effectiveness of different remote~     approaches to improving blood pressure (BP) control.~   "
11500|NCT03416270|"~     This study aims to elucidate the mechanisms whereby the SGLT2i ertugliflozin modifies~     cardiorenal interactions that regulate fluid volume and neurohormonal activation in patients~     with type 2 diabetes and heart failure (T2D-HF).~   "
11501|NCT03416257|"~     In the present study, the investigators sought to prospectively examine the associations of~     plasma levels of TMAO, choline, betaine, dimethylglycine, and sarcosine with risk of incident~     carotid artery plaque, assessed by repeated B-mode carotid artery ultrasound imaging over a~     7-year period, in women and men with and without HIV infection from the WIHS and MACS.~   "
11502|NCT03416244|"~     Cancer - including esophageal squamous cell cancer (ESCC) - is a disease of the elderly but~     little is known about the biology and progression of cancers in these patients.~      While most patients receive chemotherapy and/or chemo-radiation as first treatment, no~     treatment standard for following treatments has been established so far and there is a clear~     unmet medical need, especially for elderly patients.~      Hence, this study assesses the efficacy and safety of two experimental immunotherapy regimens~     (Nivolumab monotherapy or Nivolumab/Ipilimumab combination) in elderly patients with advanced~     esophageal squamous cell cancer.~   "
11503|NCT03416231|"~     The purpose of this study was to evaluate the effectiveness and safety of apatinib combined~     with docetaxel in NSCLC.~   "
11504|NCT03416218|"~     The purpose of this study is to evaluate a game-based intervention (Prognosis) designed to~     improve science, technology, engineering, and mathematics (STEM) skills among high~     school-aged students.~   "
11505|NCT03416205|"~     Endoscopic retrograde cholangiopancreatography (ERCP) is commonly performed to remove bile~     duct stones.Endoscopic sphincterotomy (EST), endoscopic papillary balloon dilation (EPBD),~     and endoscopic sphincterotomy plus balloon dilation (sEST+EPBD) are 3 methods used to enlarge~     the papillary orifice, but their efficacy and safety remains controversial. This study aimed~     to compare these methods for treating common bile duct (CBD) stones.~   "
11506|NCT03416192|"~     The medium cut-off dialysis (MCO) membrane has been developed to improve middle molecule~     removal compared to standard high-flux dialysis filters.~      The aim of this study is to compare levels of middle molecules after 12 weeks of MCO~     hemodialysis, compared to 12 weeks of hemodiafiltration using standard high-flux filter.~   "
11507|NCT03416179|"~     Glasdegib is being studied in combination with azacitidine for the treatment of adult~     patients with previously untreated acute myeloid leukemia (AML) who are not candidates for~     intensive induction chemotherapy (Non-intensive AML population).~      Glasdegib is being studied in combination with cytarabine and daunorubicin for the treatment~     of adult patients with previously untreated acute myeloid leukemia (Intensive AML~     population).~   "
11508|NCT03416166|"~     For a long time, tricuspid valve disease has been considered as less important than~     left-sided valvular heart disease. If treated in an advanced stage and simultaneously with~     other cardiac diseases, it is associated with significant morbidity and mortality. Hence,~     physicians tend to refer patients more aggressively to surgery (1).~      Transcatheter procedures are an attractive alternative in high-risk patients. The field of~     transcatheter tricuspid devices has rapidly advanced over the last few years (2). Limited~     knowledge is available regarding the epidemiologic and anatomical settings in which these~     therapies are preferentially applied.~      The main purpose of this registry is the collection of baseline clinical and anatomical data~     of the patients treated with transcatheter tricuspid valve therapies, and their outcomes,~     whenever feasible. Apart from more knowledge regarding the current status in this field, the~     results could also help the establishment of guidelines with respect to the choice of the~     transcatheter device selected and to understand which therapy can provide the better outcome~     in the different anatomies. Moreover, this study will provide important information about the~     epidemiology of severe tricuspid regurgitation, which is at the moment an undertreated~     disease.~   "
11509|NCT03416153|"~     This prospective study aims to utilize pre- and mid-treatment PET-CT to guide de-escalation~     of radiation therapy in HPV-related squamous cell carcinoma of the oropharynx.~   "
11510|NCT03416140|"~     The purpose of this study is to assess the effectiveness and safety of the therapeutic~     exercise effects in patients with chronic kidney disease. An randomized clinical trial is~     carried out. A total sample of 70 patients with chronic kidney disease is recruited and~     divided into a therapeutic exercise group and a control group. The kidney function~     (creatinine clearance as main outcome) is measured at baseline and 1 month after treatment~     start.~   "
11511|NCT03416127|"~     Glycemic control is naturally the principal topic of diabetes and complications that can be~     developed as a consequence of loss of sensitivity to perceive insulin signals by the cell.~     The glycemic control goals established by the ADA are: glycosylated hemoglobin (A1C) <7.0%,~     fasting plasma glucose 80-130 mg/dL and casual plasma glycemia <180 mg/dL. The first-line~     treatment in patients of recent diagnosis is metformin, however, studies have shown that~     propolis, a resinous balsamic material collected by the Apis mellifera bee, from sprouts,~     exudates of trees and other parts of the plants, represents a very important and promising~     natural alternative in medicine, which can be considered as an antidiabetic agent.~      The aim of this study is to evaluate the effect of propolis or metformin administration on~     glycemic control in patients with type 2 Diabetes Mellitus without pharmacological treatment.~      The investigators hypothesis is that propolis or metformin administration, modify the~     glycemic control in patients with type 2 Diabetes Mellitus without pharmacological treatment.~   "
11512|NCT03416114|"~     Retro-prospective survey on specific and overall prevalence and incidence of rare primary~     headaches (Part One, Chapter 3 and Chapter 4, ICHD-3 beta) in patients referred to Italian~     Tertiary Headache Centres in a 3-year (May 1, 2014-April 30, 2017 - retrospective data) and~     annually (from May 1, 2017 - prospective data).~   "
11513|NCT03416101|"~     In Siewert type II adenocarcinoma, the relationship between adenocarcinoma sub types and~     survival, histologic/biologic patterns related to the presence/absence of gastric greater~     curvature metastases, were investigated.~   "
11514|NCT03416088|"~     The daily behaviors such as drinking,coffee and reading may have influence on the function or~     morphology of the retinal microcirculation in healthy people.A recent study found that the~     fingertips microvascular bed constricted obviously after the intake of a cup of coffee with~     caffeine, it significantly reduced blood flow to the fingers; Long reading of electronic~     products can induce significant dry eye symptoms, affect visual quality, and cause~     asthenopia. Microcirculation is critical for regulating vascular resistance and blood flow in~     organs. Fundus blood vessels is the only visible microvascular in vivo, its morphology and~     function changes not only associated with eye disease, but also with cardiovascular and~     cerebrovascular diseases. Optical coherence tomography angiography (OCTA) is a new technique~     which could acquire blood flow information in a non-invasive way without the use of dye. The~     study tried to detect the influence of daily behaviors such as drinking, coffee and reading~     on the retinal microcirculation with OCTA, and provide reference for health behaviors.~   "
11515|NCT03416075|"~     To identify risk factors for mortality in patients with interstitial lung disease receiving~     mechanical ventilation.~   "
11516|NCT03416062|"~     The trial intends to study the safety and efficacy of Remaxol® (succinate + methionine +~     inosine + nicotinamide; POLYSAN Ltd., Russia),solution for infusion for the reduction of~     hyperbilirubinemia in patients with obstructive jaundice caused by tumor (malignancy).~   "
11517|NCT03416049|"~     The purpose of this study is to determine the clinical effectiveness of a low-power PEMF~     device, a medium-power PEMF device and a high-power PEMF device as compared to a sham device~     to treat leg ulcers resulting from venous stasis (VSLU).~   "
11518|NCT03416036|"~     The purpose of this study is to evaluate the ability of a single dose of a live attenuated~     recombinant tetravalent dengue vaccine (TetraVax-DV-TV003, referred to as TV003) to protect~     against infection with a controlled human infection strain of either DENV-2 (rDEN2Δ30-7169)~     or DENV-3 (rDEN3Δ30) in adults 18 to 50 years of age with no history of previous flavivirus~     infection.~   "
11519|NCT03416023|"~     Study to assess the safety, performance and durability of the TIES® transcutaneous titanium~     implant in patients requiring a permanent ileostomy.~   "
11520|NCT03416010|"~     The overall purpose of this application is to evaluate the efficacy of an intervention~     designed to decrease health disparities in pregnant, emotionally distressed, minority women.~     This randomized controlled trial will test a six session (spaced over 18 weeks) cognitive~     behavioral skills building (CBSB) prenatal care intervention (specifically designed and based~     on prior research for pregnant minority women experiencing emotional distress) at two sites~     (Jacobi Medical Center, New York City and The Ohio State University Total Health and Wellness~     Clinic,Columbus, Ohio.~   "
11521|NCT03415997|"~     The purpose of this study is to evaluate the effect of dosing iodinated contrast media~     according to a patient's total body weight vs. lean body weight. Participants will be~     randomized into 2 groups based on contrast dosing technique, and solid organ enhancement at~     uniphasic abdominal CT will be measured.~   "
11522|NCT03415984|"~     Age related macular degeneration (ARMD) is a major and irreversible cause of blindness among~     the elderly. The sub-retinal space, located between the retinal pigmentary epithelium (RPE)~     and the external segments of the retinal photoreceptors, plays a crucial role in this~     pathology. A recent epidemiologic study in the US, has shown that Parkinson patients treated~     with L-DOPA, developed only later an ARMD when compared to the untreated patients.~      The L-Dopa is an endogenous ligand of the GPR43 receptor (G protein-coupled receptors),~     located on the RPE's cell's apical pole.~      This receptor, via several intracellular mechanisms, regulates the cell's exosomal and~     endosomal pathways: it would appear that the L-DOPA, by stimulating this receptor, decreases~     significantly the RPE's exosome release.~      The contents of the exosomes is still uncertain, however in addition to their signalization~     role, it seems they transport pro-inflammatory components, possibly helping the cellular~     recruitment due to the mononuclear phagocytic systems, particularly toxic for the~     photoreceptors.~      The aim of this study is to estimate the prevalence of ARMD in a sample of Parkinson's~     Patients followed at Fondation Ophtalmologique Adolphe de Rothschild and to compared it to~     the prevalence of ARMD of the general population.~      Furthermore the study aims to explore a possible causal link between L-DOPA treatment and~     ARMD.~   "
11523|NCT03415971|"~     The result of the study will demonstrate that the functional activity of maxillofacial area~     with edentulous posterior bounded spaces recovers more effectively in patients treated with~     restorations on implants comparing to patients treated with fixed dentures.~   "
11524|NCT03415958|"~     Outcomes for displaced midshaft clavicle fractures in adolescents are not defined. The~     current method of treatment for these fractures is non-operative management. There is recent~     Level 1 evidence in the adult literature to suggest that outcomes are superior when these~     fractures are managed surgically with open reduction and internal fixation.~   "
11529|NCT03415893|"~     EA is one of the most frequent birth defects, with an incidence of 1 in 3000 live births1.~     Until the 1950s, these patients had 100% mortality; nowadays, the survival rate is greater~     than 90%, and only those with associated severe malformations die1-5.~      Type C EA (atresia of the esophageal proximal segment with tracheoesophageal fistula between~     the trachea and the distal segment) is the most common variant, since it is present in 85% of~     the cases6-8. There is evidence that the esophageal motor disorder present in these children~     is secondary to a congenital neuromuscular disorder and a postoperative disorder9-14.~     Patients that survive the operation have greater risk of developing gastroesophageal reflux~     disease (GERD), caused by anomalies in the esophageal motility and its resulting delay in the~     evacuation of acid of the esophageal lumen.~      There was a hypothesis that suggested that motility alteration could contribute to dysphagia~     and to the high prevalence of gastroesophageal reflux in these patients15-18. Also, there~     were reports of a greater incidence of severe esophagitis with requirement of fundoplication,~     which shows a larger failure rate17-18. Esophageal dysmotility has been proved in children~     with EA through performance of conventional perfusion manometry.~      Lemoine C et al described three motility alteration patterns with HRM in children with~     repaired EA. Said study allowed a more precise knowledge of segmental esophageal motility19.~     Currently, there are no reports exclusively made about teenagers with repaired EA that~     describe segmental esophageal motility with HRM.~   "
11530|NCT03415880|"~     In type 2 diabetes (T2D), physical activity is an important modifiable risk factor of~     cardiovascular disease (CVD). Unfortunately (long-term) compliance to exercise programs in~     patients with T2D is poor. Light-intensity physical activity (LiPA) such as walking slowly,~     household activities or taking a flight of stairs might be a potential target for lowering~     the CVD risk in patients with T2D since it can perhaps be more be incorporated into daily~     life. To assess cardiovascular disease risk in this single-blinded RCT, the investigators~     settled on measuring arterial stiffness as the primary outcome. Arterial stiffness has~     independent predictive value for cardiovascular events and can be measured reliably and~     non-invasively. The investigators hypothesize that light intensity physical activity~     intervention program based upon increasing LiPA by replacing sedentary time is effective in~     lowering arterial stiffness as estimated by aortic pulse wave velocity (PWV) and carotid~     distensibility in individuals with T2D.~   "
11531|NCT03415867|"~     This is a phase 1b/2a, open label, multi-centre, safety and efficacy study of glasdegib in~     patients with sclerotic cGVHD refractory to second-line treatment. The design for the current~     study is a standard 3+3 dose-finding scheme. A dose escalation/de-escalation design will be~     applied in successive patient cohorts until identification of MTD. Glasdegib will be~     self-administered orally once daily in the morning as monotherapy in continuous 28-day~     treatment cycles for a maximum of 12 cycles.~   "
11532|NCT03415854|"~     The purpose of this study is to determine if the combination of paclitaxel protein bound,~     gemcitabine, cisplatin, paricalcitol are effective in individuals with previously untreated~     metastatic pancreatic cancer.~   "
11533|NCT03415841|"~     This study hopes to target the remaining 80% of low risk post-myocardial infarction patients~     who have refused uptake the traditional cardiac rehabilitation program In Changi General~     Hospital. This is a 6-week home-based Cardiac rehabilitation program enabling patients to~     track their blood pressure, physical activity and medicine compliance through a mobile~     application. Each patient in the intervention arm is provided with a blood pressure monitor,~     activity tracker and a single lead ECG monitor. The data from these devices would be~     automatically synced by a mobile application and uploaded to a confidential web portal which~     is only accessible by physician care-givers. The application also provides educational~     content/tasks, appropriate reminders for taking medications and daily goals on activity~     targets set by the care provider. This would help to engage the patients to enable~     behavioural change and improve compliance to mediation and activity recommendations.~      In general, 50 patients who are randomized to the intervention group (mHealth) will be~     enabled with remote monitoring devices (ECG, Blood Pressure, Activity tracker) and Kardia~     mobile application, for home-based rehabilitation program followed by review in the~     outpatient Cardiology clinics. The control group (50 subjects) will just be monitored at~     fixed intervals in the outpatient Cardiology clinics. Fu AT 3-4 months & 9-12 months.~     Subjects will be advised to commence the exercise program 2 weeks after the myocardial~     infarction. Block randomization using sequentially numbered sealed envelopes would be used to~     assign subjects to the intervention or control arms. The primary outcome measure is~     compliance and adherence to the Kardia program. Other endpoints include 6MWT, patient~     wellbeing and behaviour (e.g. dietary habits, stress levels, physical activity) assessed~     using questionnaires, major adverse cardiovascular events (MACE), modification of~     cardiovascular risk profiles (i.e. LDL, BP, BMI, HbA1c, etc) and medicine compliance.~   "
11534|NCT03415828|"~     DISCOGEL® is on the market since 2007. About 20,000 kits were sold to date (October 2017).~     The device re-obtained its CE mark in 2017.~      A clinical evaluation was performed by bibliographic route in 2016. Clinical data on more~     than 600 patients treated by DISCOGEL® were analyzed. These data should be confirmed by~     monitoring on the long term, with a large cohort of patients, over a two-year follow-up~     period.~      As part of the post-CE surveillance, the manufacturer GELSCOM is responsible of this~     Post-Market Clinical Follow-up (PMCF) study in accordance with Directive 93/42/EEC and~     MEDDEV guide 2.12/2, to assess the efficacy and the long-term safety of DISCOGEL®.~      The study is comparative. The results will evaluate the performance and safety of the~     CE-marked medical device used in real life, in comparison with a steroid infiltration, used~     according to its indication and to the current standards. It will include economic data.~     Patients and evaluators will be blinded. Both DISCOGEL® and HYDROCORTANCYL 2,5 POUR CENT are~     authorized products used according to their intended use.~      This is an interventional, prospective, national, multi-center, comparative, randomized,~     single-blind (patient and evaluator) post-market clinical study. The primary objective is to~     compare the short-term efficacy profile of DISCOGEL® versus intradiscal steroid.~   "
11535|NCT03415815|"~     The real-world observational study was designed to explore lymph metastases and prognoses of~     the Chinese patients with thoracic T1-T3 esophageal cancer~   "
11536|NCT03415802|"~     Pancreatic cancer is a common malignancy of digestive system with gradually increasing~     incidence, is the fourth and seventh leading cause of cancer-related mortality in the world~     (1) and China (2) according to the statistics in 2014. The vast majority of patients were~     confirmed as locally advanced or distantly metastatic disease at diagnosis with an estimated~     five-year survival rate of 4% (3) due to occlusive development and rapid progress. Advanced~     pancreatic cancer is characterized by poor prognosis.~   "
11537|NCT03415789|"~     This study is designed to quantify the ventricular stasis in patients with non-ischemic~     dilated cardiomyopathy by post-processing of 2D color Doppler echocardiography images in~     order to establish the relationship between quantitative variables of intraventricular stasis~     and the prevalence of silent embolic events and/or intraventricular mural thrombosis~     determined by magnetic resonance.~   "
11538|NCT03415776|"~     Hemodialysis is the most worldwide prescribed renal replacement therapy for patients with~     end-stage renal disease. The frequency of sessions per week remains a debatable issue. In the~     majority of developed Western and Asian countries, patients on chronic hemodialysis are~     undergoing three dialysis sessions weekly. In developing countries and some developed~     countries, a twice-weekly schedule independent of residual kidney function is still accepted,~     sometimes because of lack of resources and some other times because of patients' resistance~     to undergo three sessions per week. The primary objective of this trial is to assess the~     total mortality of patients on thrice against twice-weekly hemodialysis. The secondary~     objectives are a) to compare the rate of urgent supplementary hemodialysis sessions between~     the two arms, mainly those due to pulmonary edema and hyperkalemia, b) to compare the number~     of hospitalizations and duration of stay, c) to compare the rate of uncontrolled hypertension~     between the two groups, d) to analyze the quantity of erythropoiesis-stimulating agents~     (ESAs) in units to achieve a haemoglobin (Hb) 11 to 11.5 g/dl, e) to assess the factors~     associated with a higher mortality in the two groups.~   "
11539|NCT03415763|"~     The purpose of this study is to evaluate the efficacy of adjuvant chemotherapy in patients~     with clinical stage III rectal cancer who received neoadjuvant chemoradiotherapy on the basis~     of postoperative pathological stage.~   "
11540|NCT03415750|"~     Clinical study with two parallel group to compare the efficacy of everolimus combination +~     tacrolimus in regression of left ventricular hypertrophy vs tacrolimus + mycophenolate~     mofetil in renal transplant patients in the maintenance phase.~   "
11541|NCT03415737|"~     As patients improve on one parametric result, the results on the other parametric may worsen,~     but the total score may not be affected. For this reason, it would be useful to make~     measurements that evaluate all the parameters of the patients. Thus, it would be more~     advantageous to score both pain and symptoms separately, as well as activity limitations.~     Therefore, neck specific surveys are needed to meet this need.~      For this reason, this study was planned to determine the validity of the questionnaire named~     Profile Fitness Mapping Neck Questionnaire in patients with neck pain.~   "
11542|NCT03415724|"~     Aim of the study is to determine and compare the anaesthetic efficacy of dexmedetomidine and~     epinephrine in combination with 2% lidocaine for inferior nerve block in patients with~     irreversible pulpitis. Study will be conducted in Post Graduate Institute of Dental Sciences,~     Rohtak in department of Conservative Dentistry & Endodontics. Vital mature permanent~     mandibular molars with radiographically exposed dentinal caries and with signs of~     irreversible pulpitis will be included in the study. The patients will be randomly allocated~     into two control and two experimental groups and nerve block will be given according to~     standard protocol.~   "
11543|NCT03415711|"~     Ulcerative colitis (UC) is an inflammatory bowel disease (IBD) characterized by chronic~     inflammation limited to colonic mucosa. Its pathogenesis is not still clear, even if a~     multifactorial aetiology has been advocated. The aim of this study is to evaluate the~     long-term efficacy of two different doses of VSL#3® added on standard therapy (5-ASA) in~     maintaining remission in an adult population of patients with UC, compared with the standard~     therapy (5-ASA) plus placebo. The investigators hypothesized that adding VSL#3® to mesalamine~     would lead to higher remission rate at long-term evaluation.~   "
11544|NCT03415698|"~     Globally, cirrhosis is the fifth commonest cause of mortality. Its natural history is~     typified by an initial, largely asymptomatic, compensated phase followed by~     decompensation due to complications of raised portal pressures and hepatocellular~     dysfunction.~      Currently the only definitive treatment option for cirrhosis is liver transplantation which~     is limited in its applicability due to donor shortage, exorbitant costs and lack of~     widespread availability. The need for long term immunosuppression and its attendant~     complications are a further drawback. The ability of stem cells to differentiate into~     multiple cellular lineages makes one speculate that they can be used for tissue repair and~     regeneration when tissue-resident stem cells become overwhelmed. Bone marrow derived stem~     cells have amazing plasticity. They can home to the liver in response to injury and help in~     liver regeneration by trans-differentiation, cell fusion and augmentation of tissue- resident~     stem cell mediated repair. Two methods are available for the mobilisation of stem cells from~     the bone marrow to the liver. One involves the administration of cytokines like~     granulocyte-colony stimulating factor (G-CSF) and the other is the isolation of stem cells~     from the marrow followed by their injection into the hepatic artery or portal vein after~     purification. The latter is probably more cumbersome and may be potentially risky due to the~     underlying coagulation abnormalities in cirrhotic patients .~      G-CSF has been shown to mobilise bone marrow stem cells and even increase survival in~     patients of severe alcoholic steatohepatitis and ACLF. There is conflicting evidence on the~     role of G-CSF in decompensated cirrhosis with some studies showing improved survival while~     others have shown a lack of clinical or biochemical benefit. Many of these studies have used~     a single course of G-CSF. Verma et al, in a recent study published in 2018, elegantly~     demonstrated the beneficial effect of multiple courses of G-CSF in improving mortality and~     transplant free survival in decompensated cirrhotics.~      The investigators too speculate that multiple cycles of G-CSF could result in better outcomes~     in decompensated cirrhosis by causing more prolonged and sustained stem cell homing to the~     liver. Thus, this study is being undertaken to further evaluate the safety and efficacy of~     multiple cycles of G-CSF in decompensated cirrhotics.~   "
11545|NCT03415685|"~     This study will evaluate the use of the Lutronic PicoPlus for treatment of dermatological~     conditions such as unwanted tattoos and benign pigmented lesions.~   "
11546|NCT03415672|"~     In the current study, the investigators study the efficacy of the HBAI20 vaccine to induce~     seroprotection in registered non-responders (adults who were previously vaccinated with the~     HBVaxPro-10μg but did not achieve seroprotection). The study will further assess the safety~     of the HBAI20 vaccine in comparison with HBVaxPro-10μg.~   "
11547|NCT03415659|"~     This is an open-label, dose-escalation, phase I clinical trial study to investigate the~     safety and tolerability of HWH340. In addition, the pharmacokinetic characteristics will also~     be investigated. Two parts are included in this study.~   "
11548|NCT03415646|"~     Postoperative analgesia in breast surgery is a difficult and overworked issue due to~     extensive surgery and complex innervation of the breast. Erector spinae plane block (ESB) is~     a new defined regional anesthesia technique for thoracic analgesia.Main purpose of this study~     was to evaluate the analgesic effect of ultrasound guided double injection ESB in breast~     surgery.~   "
11549|NCT03415633|"~     To assess the diagnostic validity and cost-effectiveness of a APNiA device, a home~     respiratory polygraphy (HRP).~   "
11559|NCT03415503|"~     In order to study the effect of anthocyanins on the improvement of glucose and lipid~     metabolism, randomized intervention trials were conducted to compare the effects of~     anthocyanins on the improvement of glucose and lipid metabolism in different dose groups.To~     explore the best dose of anthocyanins for the prevention and treatment of anthocyanin~     metabolic diseases provide an important scientific basis.~   "
11560|NCT03415490|"~     The purpose of this study is to evaluate the interface pressure measurements of applying~     self-adherent wraps on eyes after orbital tumour extirpation.~   "
11550|NCT03415620|"~     The use of music to relieve pain has been studied in many forms of medicines and has been~     proven to reduce anxiety, pain and analgesic use in the perioperative setting. However, music~     listening as an inexpensive and duplicable method has not been investigated and implemented~     in the local context. The investigators hereby propose a prospective study to recruit~     patients undergoing surgery to evaluate the effectiveness of music in pain relief and~     post-operative recovery; as well as the implementation and operational readiness of music~     listening.~      Patients will be offered to select from pre-determined lists of music of different genres or~     patient choice, before and after surgery. Hospital Anxiety and Depression Scale (HADS) score,~     pain scores, analgesia usage, patient satisfaction, and quality of life measurement will be~     collected. Analysis of the type of music, duration of music listening, and the genre chosen~     will be analysed.~      This study will investigate the clinical relevance of music for pain relief in local context~     and cultural settings. The implementation and operational readiness of music listening can~     then be adopted as a non-invasive pain relief intervention in local surgical settings. This~     will prove patient outcomes with lower cost, greater efficacy and safety.~   "
11551|NCT03415607|"~     Succinylcholine is a myorelaxant agent often used during rapid sequence induction for~     patients who need to undergo general anesthesia but who are at risk of pulmonary aspiration~     of gastric content. Whereas other myorelaxant agents are monitored with train of four~     stimulation to assess onset and duration, few anesthesiologists use train of four stimulation~     for onset of succinylcholine, as the anesthesiologists evaluate the effect with the time from~     injection (usually one minute) and the muscle fasciculation due to the release of~     acetylcholine.~      The data available on onset duration of this drug are old and bases on only few studies, but~     the succinylcholine if sometime harmful (anaphylaxis , cardiac arrest, bronchospasm).~      The investigators want to assess the onset time of succinylcholine with an objective toll ,~     the train of four stimulation, and evaluate if the clinical judgment of the anesthesiologist~     is reliable to predict an adequate moment for endotracheal intubation.~   "
11552|NCT03415594|"~     once weekly dosing for 4 weeks in patients with short bowel syndrome who require total~     parenteral nutrition; patients will complete period 1 and after a 6-10 week wash-out, they~     will enter period 2 (active treatment and placebo)~   "
11553|NCT03415581|"~     Healthy, adult men and women, aged 21 to 59 years, who abuse opioids and are physically~     dependent on them will be recruited to participate in a study to examine the ability of~     doxazosin, an epinephrine receptor blocker, to alter the abuse potential of oxycodone. After~     participants complete the screening process, they will be scheduled for inpatient admission~     onto our clinical inpatient where they will reside during the 8-week study. During Weeks 1-2,~     participants will be transitioned from their normal opioid use regime onto oral morphine~     until withdrawal dissipates. At this time participants will also be stabilized on the first~     dose of doxazosin (0 or 16 mg/day; active doxazosin will be started at 4 mg and increased by~     4 mg every 3 days). During Weeks 3-4, either active or placebo oxycodone will be available~     (in random order). Monday-Friday each these drugs will be tested using our sample and choice~     self-administration procedure. On Friday, participants will also complete a cue exposure~     session during which they will be presented drug cues to determine whether the study~     medication affects how participants react to them. To summarize, Weeks 1-2 and 5-6 will be~     stabilization weeks (0 or 16 mg doses of doxazosin administered in random order) and Weeks~     3-4 and 7-8 will be test weeks under each of the doxazosin maintenance doses. At the~     conclusion of the study, participants will be given an exit interview, warnings about~     re-initiation of opioid use, and counseling about the different treatment options for Opioid~     Use Disorder. Within 1 week after discharge, investigators will assess adverse events using~     the a number of clinical assessments. At each weekly visits, investigators will assess~     participants' interest in treatment and drug use patterns.~   "
11554|NCT03415568|"~     It is well known that medium chain triglycerides (MCTs) and diacylglycerols (DGs) have~     effects on lowering circulating triglycerides (TGs). In this study, the mixture of MCTs and~     DGs (MCDGs) examined whether it has beneficial effects on postprandial lipids metabolism~     compared to long-chain triglycerides (TGs).~   "
11555|NCT03415555|"~     Patients scheduled for minimally invasive mitral valve replacement. Each patient will be~     treated with intravenous (i.v.) oxycodone - patient-controlled analgesia (PCA). Half of the~     patients will be randomly allocated to Erector Spinae Plane (ESP) blockade group.~   "
11556|NCT03415542|"~     Regular aerobic exercise is associated with reduced risk of multiple cancers, yet the~     majority of adults are inactive. Across health behavior theories, the expectations people~     have about the outcomes of exercise influence their decision to exercise. Extending prior~     work, a fine-grained analysis of the relationship between perceived outcomes and daily~     exercise behavior will be achieved using ecological momentary assessment methods to measure~     perceived outcomes, and accelerometry to measure exercise objectively. The results of this~     research will inform exercise promotion efforts by determining how perceptions and temporal~     factors interact to predict exercise behavior.~   "
11557|NCT03415529|"~     There appears to be considerable variability in the approach physicians use to manage~     arterial carbon dioxide tensions, in patients in the early phases [first 48 hours] of ARDS~     (Acute hypoxemic respiratory failure and). A number of specific concerns exist, particularly~     the use of greater than needed inspired oxygen concentrations (potentially in 40% patients),~     and the proportion of hypocapnic patients in our cohort.~   "
11558|NCT03415516|"~     The aim of this randomized, controlled, prospective clinical trial is to evaluate the~     performances of two different universal adhesives and an etch&rinse adhesive in restoration~     of non-caries cervical lesions. Twenty patients will receive restorations. Lesions will be~     divided into 7 groups according to adhesive systems and application modes: GSE: Gluma~     Universal- self etch, GSL: Gluma Universal-selective etching, GER: Gluma~     Universal-etch&rinse, ASE: All Bond Universal- self etch, ASL: All Bond Universal- selective~     etching, AER: All Bond Universal- etch&rinse, SB (Control): Single Bond2+etch&rinse.~     Restorations (nano-hybrid composite) will be scored with regard to retention, marginal~     discoloration, marginal adaptation, recurrent caries and post operative sensitivity using~     modified USPHS criteria after 48 months. Two examiners who is not involved in the placement~     of restorations will conduct the evaluations. Descriptive statistics will be performed using~     Chi-square tests.~   "
11586|NCT03415152|"~     A prospective observational program using digital technology tools to enhance patient~     adherence to Omacor therapy~   "
11561|NCT03415477|"~     The efficacy of traditional therapeutic approaches for aneurysmal bone cysts (ABC), such as~     surgery, embolization, sclerotherapy and radiotherapy, are often compromised for lesions in~     axial skeletons and adolescents complicated with pathological fracture. Therefore, denosumab,~     a new drug that has been successfully used in giant cell tumor of bone but has seldom used in~     ABC, was used to treat ABC in this trial.~   "
11562|NCT03415464|"~     Physical readiness of military personnel is a corner stone of each army, as soldiers are~     expected to meet high physical demands on a daily basis and soldiers have mandatory one hour~     of physical conditioning each day. Participation in physical conditioning rises the risk for~     musculoskeletal injuries, and our 10-year retrospective analysis shows that each year 5% of~     soldiers sustain a sports injury during physical conditioning and that ankle and knee~     injuries have highest incidence rate of 25% and 20%, respectively. The primary aim of our~     study is to lower the rate of ankle and knee injuries through implementation of preventive~     exercise program. The study is designed as a prospective randomized controlled trial with two~     arms (experimental and control).~   "
11563|NCT03415451|"~     For Head and neck cancer and uncooperative patients, blind nasogastric tube (NGT) insertion~     may sometimes be very difficult because of the anatomical obstructions in the pharynx and~     uncoordinated swallowing motion. To solve the problem, flexible endoscope has been used~     widely to assist the NGT insertion via direct visual assistance, working channels/guide~     wires, or suture fixation. Unfortunately, these tools are not easily assessed in the~     outpatient department. Here, we try to use a simpler method for the flexible endoscope to~     guide the NGT insertion.~   "
11564|NCT03415438|"~     The purpose of the study is to compare the elasticity of thoracolumbar fascia in patients~     with and without subacromial impingement syndrome.~      30 patients diagnosed as subacromial impingement syndrome in physical medicine and~     rehabilitation department of Baskent University will be recruited as group 1. 30 healthy~     volunteers will be recruited as group 2. Visual Analogue Scale (VAS) with the aim of~     assessing pain severity, tape measurement for posterior capsule shortness; body lateral~     flexion, rotation and extensor movements and lumbar extensor shortness will be observed for~     correlation with thoracalumbal fascia flexibility. Lateral flexion, flexion, and extension~     movements will be measured using goniometry for trunk normal joint movements. The~     thoracolumbar fascia length test and Modify Schober test will be used for thoracolumbar~     fascia length.~   "
11565|NCT03415425|"~     The proposed study aims to examine several iterations of the Influenza Best Practice Alert at~     NYU Langone Health. The goal is to increase ordering of the influenza vaccine through the~     alert.~   "
11566|NCT03415412|"~     The aim of this randomized, controlled prospective clinical trial is to evaluate and compare~     the performances of three different universal adhesives using a flowable universal composite~     resin in the restoration of non-caries cervical lesions over 48-month period.Participants~     over 18 will be included to the study. Oral hygiene instructions will be given before~     procedures. All the lesions will be restored by the same clinician who will not participate~     to the selection of patients for eligibility. Each patient will receive at least three~     restorations and randomization will be applied using a table of random numbers. All lesions~     will be cleaned before restoring. Adhesive procedures and restorations will be placed~     according to manufacturers' recommandation.~      The flowable universal composite resin will be placed in bulk and light-cured for 40 seconds.~     The restorations will be contoured and polished with Optidisc discs (Kerr Coorporation,~     Orange, CA, USA).~      Patients will be recalled at baseline and will be recalled at control periods after~     placement.~   "
11567|NCT03415399|"~     This study is to determine the safety, including potential dose limiting toxicities, of~     ET190L1-ARTEMIS™ T cells and the duration of in vivo survival of ET190L1-ARTEMIS™ T cells in~     patients with relasped/refractory B-cell lymphoma. For patients with detectable disease, the~     study will also measure anti-tumor responses after ET190L1-ARTEMIS™ cell infusions.~   "
11568|NCT03415386|"~     A multi-center study will be done to explore the optimal regimen of antithrombotic therapy~     for acute myocardial infarction with left ventricular mural thrombus. The investigators will~     evaluate the different combinations of antiplatelet drugs and anticoagulants for at least one~     month, such as aspirin 100mg qd+clopidogrel 75mg qd+warfarin (INR1.8-2.5), aspirin 100mg~     qd+clopidogrel 75mg qd+dabigatran 110mg bid, aspirin 100mg qd+ticagrelor 60mg bid+warfarin~     (INR1.8-2.5), and aspirin 100mg qd+ticagrelor 60mg bid+dabigatran 110mg bid. Transthoracic~     two-dimensional echocardiography will be done at the 1-month, 3-month and 6-month follow-ups~     to evaluate the left ventricular mural thrombus and determinate whether the antithrombotic~     therapy regimen could be regulated to double antiplatelet or anticoagulant+clopidogrel 75mg~     qd/ticagrelor 60mg bid. Then the investigators will complete the 12-month follow-up to~     evaluate the efficacy and safety of the optimal antithrombotic therapy regimen for acute~     myocardial infarction with left ventricular mural thrombus.~   "
11569|NCT03415373|"~     Microdermics Inc. is a British Columbia-based Canadian incorporation primarily focusing on~     microneedle-based painless and effective drug delivery systems.The Microneedle Adapter (model~     UAR-2S) is a single-use disposable medical device intended to provide a mechanism for~     intradermal bolus fluid delivery when used with a standard syringe with a Luer-lock tip~     connection. The Microneedle Adapter consists of a single-use gold-coated metallic microneedle~     integrated within the microneedle adapter with fluidic connections to a standard Luer syringe~     mount. The primary function of the Microneedle Adapter is to guide the microneedle into the~     skin in a controlled manner for successful insertion passing the stratum corneum layer. The~     fluid loaded onto the syringe can then be injected precisely intradermally into the skin.The~     primary objective of this study is to evaluate the performance of the Microneedle Adapter in~     healthy subjects in 3 different injection sites. Pain perception of the Microneedle Adapter~     will be a key secondary outcome, compared with the control device.~   "
11587|NCT03415139|"~     This clinical research studies the physiology and immunology of new-onset post-transplant~     diabetes mellitus in patients undergoing allogeneic stem cell transplantation. Oral glucose~     tolerance tests (OGTT), hyperglycemic clamps, and immune assays will be used to define the~     mechanisms associated with abnormal glucose homeostasis following stem cell transplantation.~     Information from this clinical trial could be used to develop standardized screening~     procedures or to develop optimal treatment strategies for patients developing post-transplant~     diabetes mellitus.~   "
11570|NCT03415360|"~     Assessment of pain intensity on the NRS. Assessment of the quality of life by SF-36 and AIS.~     Diagnostic/prognostic nerve block with 5 ml of 2% lidocaine under real-time ultrasound~     control with confirmation of the correct position of the needle using a peripheral nerve~     stimulator.~      Reassessment of pain intensity on the NRS 30 minutes after local anesthetic block.~      Cryoablation under real-time ultrasound control if the NRS value is reduced by ≥ 2 points.~      If pain intensity on the NRS reduced by less than 2 points, reassessment 60 minutes after~     local anesthetic block.~      Cryoablation under real-time ultrasound control if the NRS value is reduced by ≥ 2 points.~      If pain intensity on the NRS reduces by less than 2 points 60 minutes after local anesthetic~     block cryoablation will not be performed.~      Cryoablation effect will be evaluated 24 hours, 7 days, 30 days, 3 months, 6 months post~     procedure.~        -  24 hours after the procedure - assessment of pain intensity and quality of life~        -  7 days after the procedure - assessment of pain intensity~        -  30 days after the procedure - assessment of pain intensity and quality of life~        -  3 months after the procedure - assessment of pain intensity~        -  6 months after the procedure - assessment of pain intensity and quality of~   "
11571|NCT03415347|"~     Pilonidal disease refers to a common disease affecting mostly young males. It may present as~     asymptomatic pits, acute and painful abscess formation, or chronic discharging sinuses. There~     are many treatment options for the latter two manifestations but broadly speaking the~     surgical treatment of acute pilonidal abscess can fall into three categories: (1) incision~     and drainage, (2) de-roofing and curettage and (3) wide local excision.~      The evidence available for the surgical management of acute pilonidal abscess is limited.~     Previous studies have consistently demonstrated that incision and drainage results in high~     recurrence rates and should not be considered as the first-line treatment option for the~     management of acute pilonidal abscess. However, it is not clear whether abscess de-roofing~     with curettage or wide local excision should be considered as the surgical procedure of~     choice in acute pilonidal abscess. There has not been a prospective randomised study~     comparing abscess de-roofing with curettage and wide local excision for acute pilonidal~     abscess. The ideal surgical procedure would be one that results in the lowest rate of abscess~     recurrence, treats the underlying pilonidal sinus thereby reducing the need for re-operation~     but has acceptable post-operative pain, complications and time to complete wound healing.~   "
11572|NCT03415334|"~     Elimination of hepatitis C virus (HCV) is the process of stopping sustained transmission of~     viral hepatitis, reducing its incidence to zero and providing access to safe, affordable and~     effective treatment and care for everyone. Consequently, HCV will not be a leading cause of~     mortality (1). The World Health Organization (WHO) called for comprehensive programs that~     enhance access to affordable treatment in developing countries as HCV was considered a global~     public health priority since 2010 and set criteria of elimination(2). A disease is eliminated~     if its controlling efforts are sufficient to prevent an epidemic from occurring in a given~     geographical area and measures must be continued to prevent re-establishment of transmission~     (3) According to the Centers for Disease Control and Prevention (CDC), HCV now surpasses HIV~     as the nation's deadliest blood-borne disease. In addition, the majority of infected persons~     are not aware of their infection as they are not clinically ill and there is no vaccine for~     Hepatitis C. It is well known that the best way to prevent Hepatitis C is by avoiding~     behaviors that can spread the disease. (4) This study is a way forward for the elimination of~     hepatitis C from Egypt through applying different public health approaches for motivating~     people and changing villagers' risky behaviors aiming at increasing the number of people~     adopting healthy practices for decreasing the incidence rate of hepatitis in El Othmaneya~     village. The proposed activities along one year were applied for 3575 inhabitants aged more~     than 12 years who were get tested for Hepatitis C Virus (HCV) antibodies. The initiative~     activities were provided by community-led coalition and supported technically by the Egyptian~     Liver Research Institute and Hospital (ELRIAH).~   "
11573|NCT03415321|"~     A mobile support application will be developed that will support mothers in the postpartum~     period and will be tested the effects of application on anxiety and depression symptoms.The~     study will consist of two phases. The first phase of the action research (participant design~     method) method will be done to provide postpartum mobile support application. In the second~     stage, postpartum mobile support application will be evaluated for the anxiety and depression~     symptoms of the mothers after six weeks of use.~   "
11574|NCT03415308|"~     The overall goal and theme of the Duke Center for Research to Advance Equity in Healthcare is~     to reduce racial and ethnic disparities in health through interventions that affect the~     clinical encounter. To achieve this goal, there is an urgent need for interventions that~     address implicit bias in healthcare. Implicit bias training is widely used to raise~     self-awareness and provide self-management tools. The overall objective is to test the~     hypothesis that implicit bias training for healthcare providers will reduce racial and ethnic~     disparities in patient- centered care. The proposed project will lay the groundwork for~     testing that hypothesis by using patient focus groups to garner a deeper understanding of~     perceptions of implicit bias in the clinical encounter; provider and health system~     stakeholder semi-structured interviews to inform refinement of the existing implicit bias~     training at Duke; and perform a pilot study of implicit bias training for providers. At the~     conclusion of this study, the investigators will have the necessary preliminary data to~     propose a definitive trial to determine the impact of an implicit bias training intervention~     for providers on racial and ethnic disparities in patient-centered care. This research will~     ultimately lead to the delivery of equitable, evidence-based, patient-centered care for all.~   "
11588|NCT03415126|"~     The study is divided into two parts. The first part of the study will test various doses of~     ASN007 to find out the highest safe dose to test in five specific groups. The second part of~     the study will test how well ASN007 can control cancer.~   "
11600|NCT03414970|"~     This randomized phase III trial studies how well hypofractionated radiation therapy works in~     preventing recurrence in patients with stage IIa-IIIa cancer who have undergone mastectomy.~     Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter~     period of time and may kill more tumor cells that remain after surgery and have fewer side~     effects.~   "
11822|NCT03412071|"~     This pilot study will assess the impact of four antimicrobial products (3 topical, one~     systemic) on the foreskin microbiome and HIV susceptibility of foreskin-derived CD4+ T cells.~     Participants will include HIV-uninfected Ugandan men presenting for elective male~     circumcision to reduce their HIV risk.~   "
11575|NCT03415295|"~     Background: The microbiota-dependent metabolite trimethylamine-N-oxide (TMAO) has been~     reported as a novel and independent risk factor for the development of cardiovascular and~     metabolic diseases, but the association with gestational diabetes mellitus (GDM) remains~     unclear.~      Objective: To investigate the association between plasma TMAO concentration and GDM in a~     two-phase study.~      Design: The initial discovery phase included 866 pregnant women (433 GDM cases and 433~     matched controls) in Wuhan China. Study participants were recruited from pregnant women who~     attended the outpatient clinics of the Department of Endocrinology, Tongji Hospital, to~     screen for GDM between August 2012 and April 2015, or pregnant women who visited the Hubei~     Maternal and Child Health Hospital or the Central Hospital of Wuhan for a routine antenatal~     checkup from May 2014 to November 2016. The inclusion criteria of participants were: age ≥ 20~     years, gestational age between 24 and 32 weeks, no history of a diagnosis of diabetes or~     gestational diabetes, and no history of receiving pharmacological treatment known to affect~     glucose metabolism. An independent replication phase study was nested within an ongoing~     prospective cohort study, namely the Tongji Maternal and Child Health Cohort (TMCHC).~     Beginning in January 2013, women receiving prenatal care prior to 16 weeks of gestation were~     invited to join the TMCHC. Exclusion criteria included pre-pregnancy diabetes, clinically~     significant neurological, endocrinological or other systemic diseases and multiple~     pregnancies. All enrolled pregnant women received a regular prenatal checkup in hospital and~     underwent an oral glucose tolerance test (OGTT) during 24-32 weeks of gestation to screen for~     GDM. 276 members who developed GDM before May 2016 and had fasting blood collected before 20~     weeks'gestation were included as cases in this analysis. Two controls were individually~     matched to each case from among women without GDM. These two studies were approved by the~     ethics committee of Tongji Medical College. All the participants gave informed written~     consent before they were included in the study. Plasma TMAO concentrations were determined by~     stable isotope dilution liquid chromatography with online electrospray ionization tandem mass~     spectrometry.~   "
11576|NCT03415282|"~     This is a multicenter, open-label Phase 1b study in pediatric patients age 2-11 years old~     with extensive atopic dermatitis.~   "
11577|NCT03415269|"~     To assess the effect of a single doses of 20 mg ambroxol hydrochloride on cough reflex~     sensitivity to citric acid, capsaicin, adenosine triphosphate (ATP) and distilled water in~     patients with acute cough related to upper respiratory tract infection~   "
11578|NCT03415256|"~     The purpose of this study is to examine the effects of passive vibration (PV) in improving~     balance and sensation in patients with diabetic peripheral neuropathy (DPN).~   "
11579|NCT03415243|"~     This clinical study will be conducted to characterize the gastrointestinal transit of two~     multi-symptoms formulations by inclusion of a radiolabel marker.~   "
11580|NCT03415230|"~     This is a randomized control trial to test the effectiveness of therapeutic massage on the~     sleep quality and the stress levels in women that have completed their treatment for breast~     cancer.~   "
11581|NCT03415217|"~     The purpose of this study is to evaluate the implementation and the effects of the~     Neighbourhood Team Development (NTD) Program, an innovative multi-component program that aims~     to provide resident centred care in long term facilities (LTC). As Canadians age, there is an~     increasing demand for LTC services. Older people residing in LTC homes and their families~     expect excellent care and services. However, literature and anecdotal evidence clearly~     indicate that LTC is not necessarily resident and family centred, nor are the care providers~     always collaborating as a team, thereby compromising the residents' quality of life.1-5~     Residents with Alzheimer's Disease or Related Dementias (ADRD), who may have difficulty~     voicing their concerns, are at particular risk of receiving poor resident centred care.6,7~     Decisions such as mealtimes in large dining rooms or early bedtimes are seldom in line with~     the residents' needs or wishes and add to the growing concern that the current LTC system is~     ill-designed and outdated. The NTD Program, designed by the investigators, aims to both~     enhance team development and resident centredness in LTC. The Program has three components,~     designed to modify the physical environment, the organization and delivery of services, and~     the alignment of staff members, to function independently and collaboratively in providing~     resident-centred care.~   "
11582|NCT03415204|"~     Post operative pain (POP) is a major obstacle on the road to healing, despite the increasing~     interest in postoperative pain management and development of pain control modalities (1).~     Postoperative pain is still insufficiently treated with more than 50% of patients suffering~     from moderate to severe pain early after surgery .Pain after orthopedic surgery is considered~     especially difficult to manage. Approximately half of total knee or hip arthroplasty patients~     present with extreme pain immediately after surgery. Total knee and hip arthroplasty often~     results not only in severe perioperative pain and debilitation, but chronic pain, joint~     stiffness, and functional disability many months or even years following the procedure.~     Various modalities of treating orthopedic POP exist, but the optimal management of~     postoperative pain remains controversial with no clear consensus of the best method.We~     suggest that acupuncture can be an effective treatment for post operative pain after total~     knee or hip arthroplasty.~   "
11583|NCT03415191|"~     The goal of this paper is to evaluate whether the pre-emptive administration of Ketamine~     would potentiate the effect of intravenous morphine analgesia in management of post~     thoracotomy pain. This was a single center, double-blind, placebo controlled, parallel-group,~     prospective study. Patients were randomly assigned to receive 1 mg/kg ketamine (Ketamine~     Group) or an equivalent dose of normal saline (Placebo Group) before thoracotomy in 1:1~     ratio. All patients received postoperatively intravenous morphine administration as~     additional analgesic regimen Primary end-point was pain relief measured with Visual Analogue~     Scale at rest. The secondary end-points were the reduction of inflammatory response expressed~     by plasma c-reactive protein levels, the morphine consumption, and the rate of side effects.~     The measurements were carried out 6; 12; 24; 36; and 48 post operative hours.~   "
11584|NCT03415178|"~     Primary Objective:~      To collect real-use (usability) data assessing the robustness and user interaction of the new~     alirocumab auto-injector device (which is referred to as SYDNEY), in unsupervised settings.~      Secondary Objective:~      Device-related:~        -  To collect real-use (usability) data assessing the robustness and user interaction of~          SYDNEY and the current alirocumab auto-injector device (which is referred to as AI) in~          supervised settings.~      Pharmacokinetics:~        -  To compare alirocumab pharmacokinetics (PK) administered using SYDNEY and AI.~        -  To evaluate alirocumab PK administered using SYDNEY.~      Anti-drug antibodies:~        -  To evaluate the development of anti-drug (alirocumab) antibodies (ADA).~      Efficacy/pharmacodynamics:~        -  To compare the percent and absolute change in low-density lipoprotein cholesterol~          (LDL-C) using SYDNEY and AI.~        -  To evaluate the percent and absolute change in LDL-C using SYDNEY.~      Safety:~        -  To evaluate the safety and tolerability of alirocumab using both SYDNEY and AI.~   "
11585|NCT03415165|"~     Is topical application of green tea polyphenols buccal tablet more effective in treatment of~     patients with symptomatic oral lichen planus in comparison with topical application of~     corticosteroids and what is the most effective concentration of polyphenols~   "
11589|NCT03415113|"~     The geriatric population is exposed to poly-medication. Furthermore, old people have~     important pharmacodynamic and pharmacokinetic changes that expose to much drug iatrogenic.~     Adverse drug effects are a great cause for hospitalization that is why the knowledge of the~     complete list of medications taken by the patient is necessary. The poly-medication in~     elderly can lead to extremely serious clinical consequences and significant costs. Reference~     documents specific to geriatrics guide the doctor in therapeutic choices. On the one hand,~     the Laroche's criteria lists all PIM of the French pharmacopoeia in elderly. On the other~     hand, STOPP/START criteria are a tool for detect PIM listing inappropriate drugs and criteria~     of potentially drug omissions. This has been validated in French language. It is important~     that any changes proposed by the geriatrician resulting in just prescription is sustainable~     beyond the hospitalization to prevent the recurrence of adverse effects. Effective~     community-hospital coordination is essential.~      Medication reconciliation is defined as the formal process of checking the complete, accurate~     list of a patient's previous medication — including drug name, dosage, frequency, and route —~     and comparing it with the prescription after a transition of care (on admission, after~     transfer to another medical unit, and/or at discharge).~      Two groups of patients will be created, one for which medication reconciliation at discharge~     will be practiced and the other a similar process but not standardized. Four to eight weeks~     after the discharge, the member of the pharmacy team is calling the usual community pharmacy~     to get the first non-hospital prescription by fax and compare the number of PIM with the~     prescription before hospitalization.~   "
11590|NCT03415100|"~     This is a single-centre, single arm, open-label pilot study to evaluate the safety and~     feasibility of CAR-NK cell treatment in subjects with metastatic solid tumours. Autologous or~     allogeneic NK cells are transfected by mRNA electroporation to prepare investigational CAR-NK~     cells with transiently enhanced specificity and activity against NKG2D-ligand expressing~     cancer cells.~   "
11591|NCT03415087|"~     56 Parturients, aged 18-40 year, undergoing elective CS were randomly assigned to receive~     sequential intrathecal injection of fentanyl and hyperbaric bupivacaine at the same rate~     (normal sequential) NS or a rapid intrathecal injection of fentanyl followed by slow~     injection of hyperbaric bupivacaine (rapid sequential) RS. Time of first rescue analgesia,~     Dose of rescue analgesics, degree of postoperative pain, incidence of hypotension,~     hypotension duration, ephedrine dose, spinal anaesthesia related complications and failed~     block were recorded.~   "
11592|NCT03415074|"~     This is a prospective single center open label randomized controlled trial aiming to assess~     the effectiveness and safety of a low protein diet (0.6 g/kg-day, mainly vegetarian)~     supplemented with ketoanalogues of essential amino-acids (sLPD) as compared to a mild protein~     restriction (0.8 g/kg-day, MPD) in reducing Chronic Kidney Disease (CKD) progression, with a~     planned total duration is of 18 months.~      Adult diabetic patients with CKD stage 4+ [estimated glomerular filtration rate (eGFR) using~     the Modification of Diet in Renal Disease 4-variable (MDRD4) formula <30 mL/min per year],~     with stable renal function (historical reduction of eGFR of < 10 ml/min-year) , proteinuria >~     3g/g creatininuria and good nutritional status (SGA A) will be enrolled.~   "
11593|NCT03415061|"~     Decline in cognitive function after surgery occurs most commonly in older patients and~     patients undergoing major surgeries, such as heart surgery. Postoperative Delirium (POD) is~     an acute disturbance in attention, awareness and cognition. The cause of POD are not fully~     understood. Insulin given intravenously during heart surgery has been shown to preserve short~     and long-term memory function after the operation. Animal study showed that insulin given via~     the nose (intranasal insulin) preserves memory function after exposing to anesthesia~     suggesting that intranasal insulin also could be a therapeutic option POD.~      This study is designed to examine the effect intranasal insulin on POD. The goal is to~     investigate whether administration of intranasal insulin during and after heart surgery~     reduces the incidence of POD.~   "
11594|NCT03415048|"~     For children and adolescents who have had a concussion resulting in prolonged symptoms (>3~     months), the investigators will:~        1. Measure post-concussion symptoms, cognitive and emotional function during the 3 years~          post-injury.~        2. Determine length of recovery and frequency of return to prior level of sports~          participation.~        3. Determine the incidence of and risk factors for subsequent concussion during the 3 years~          post-injury.~   "
11595|NCT03415035|"~     This study will evaluate real-life effectiveness and use in participants starting venetoclax~     treatment for Chronic Lymphocytic Leukemia (CLL).~   "
11596|NCT03415022|"~     The present study is an open trial that seeks to examine the feasibility, acceptability,~     mechanism, and efficacy of a recently developed computer-based therapy in individuals with~     social anxiety disorder (SAD)~   "
11597|NCT03415009|"~     Response to peginterferon and ribavirin treatment in hepatitis C (HCV) depends on viral and~     host factors. Single nucleotide polypmorphisms (SNP) near to IL28B gene (especially at~     rs12979860 and rs8099917) are strongly associated with the response to treatment in HCV~     genotype 1 infection, less so in HCV genotype 2/3 infection. CC genotype in rs12979860 and TT~     genotype at rs8099917 are associated with good treatment outcome. Asian populations have high~     prevalence of CC genotype in other studies, which can explain relatively good response to~     peginterferon/ ribavirin in genotype 1 infection in Asians compared with Caucasians.~   "
11598|NCT03414996|"~     To date, no studies have evaluated the safety or efficiency (improvement of maximal oxygen~     uptake [VO2peak]) of a high-intensity interval training (HIIT) program in post-acute coronary~     syndrome (post-ACS) patients. Heart rate variability (HRV) and recovery (HRR), QT dispersion~     (QTd) and ventricular arrhythmias are all indices associated with an increased risk of~     cardiac death. HIIT has been shown to improve these risk markers and be safe in coronary~     heart disease patients but not yet in post-ACS patients which are considered more at risks.~      The aim of this study was to compare a HIIT program to a moderate-intensity continuous~     exercise training (MICET) program on HRV, HRR, QTd parameters and occurrence of ventricular~     arrhythmias in post-ACS patients.~   "
11599|NCT03414983|"~     This purpose of this study is to evaluate nivolumab (BMS-936558) in combination with standard~     of care (SOC) chemotherapy with bevacizumab for the treatment of first-line metastatic~     colorectal cancer (mCRC).~   "
11615|NCT03414775|"~     This study evaluates the effects of either Pediasure or Nourish formulas on the~     gastrointestinal microbiome in critically-ill children. Patients will be randomized to~     received either Pediasure or Nourish.~   "
11601|NCT03414957|"~     The abnormalities that characterize the Metabolic Syndrome (MetS) confer an increased risk of~     cardiovascular and other diseases. Women with Polycystic Ovary Syndrome (PCOS), the commonest~     endocrine disease among women of childbearing age, have an increased risk of developing MetS.~      2) The prevalence of MetS in PCOS patients varies among different ethnic groups. Malaysia is~     a unique country with a multiethnic population. The 3 largest ethnic groups are the Malays,~     Chinese and Indians. Previous studies in India and China have been able to determine the~     incidence of PCOS amongst those ethnic groups, but as yet, there is no published data on the~     prevalence of this disorder amongst women of Malay ethnicity. In this study, I intend to~     discover the prevalence of MetS amongst Malay women with established PCOS.~   "
11602|NCT03414944|"~     Brain metastases are the most common intracranial tumors in adults. Whole-brain radiation~     therapy (WBI) increases the median survival of patients with brain metastases up to 3-6~     months, but WBI can lead to the decline of cognition and quality of life, with short local~     control time. The use of SIB(simultaneous integrated boost) technology can increase the local~     control rate. Hippocampus avoidance can effectively reduce the cognitive impairment caused by~     WBI.This study was designed to evaluate the safety and efficacy of selective brain~     radiotherapy (EBI)(based on SIB and hippocampus, inner ear avoidance )in NSCLCs with limited~     brain metastases.~   "
11603|NCT03414931|"~     Major depressive disorder (MDD) is a complex and multi-factorial disorder. Most of the~     current antidepressants are based upon the monoamine hypothesis which cannot fully explain~     the etiology of depression. Many elderly patients have significant side effects after~     treatment with antidepressants which hamper the motivation for treatment and medication~     adherence. NMDA hypofunction has been implicated in the pathophysiology of depression. MDD in~     the elderly is often associated with cognitive deficits which are not necessarily recovered~     by current antidepressants. The NMDA receptor regulates synaptic plasticity, memory, and~     cognition. In our previous studies, cognitive improvement has been observed with treatment of~     NMDA enhancers. Therefore, this study will examine the efficacy and safety as well as~     cognitive function improvement of NMDAE in the treatment of MDD in the elderly by comparing~     with sertraline (a selective serotonin reuptake inhibitor [SSRI]) and placebo.~      The investigator will enroll elderly patients with MDD for an 8-week treatment. All patients~     will be randomly assigned into three groups: NMDAE, sertraline, or placebo. The investigator~     will biweekly measure clinical performances. Cognitive functions will be assessed at baseline~     and at endpoint of treatment by a battery of tests. The investigator hypothesize that NMDAE~     can safely yield better efficacy than placebo and sertraline for elderly patients with MDD.~   "
11604|NCT03414918|"~     This study evaluates if :~      1 ) the plasma aldosterone concentration and blood pressure change in response to~     roxithromycin could be useful for the screening of PA patients carrying a KCNJ5-mutated APA;~     2) the change of PAC in response to mutated KCNJ5 channel is truly occurring in KCNJ5-mutated~     APA.~   "
11605|NCT03414905|"~     Indwelling tunneled pleural catheters have been successfully used to palliate dyspnea~     associated with recurrent malignant pleural effusions with few complications and spontaneous~     pleurodesis occurring in 30-50% of patients when using vacuum assisted drainage systems.~     Notably, all data on palliation of dyspnea as well as on rates of spontaneous pleurodesis~     have been performed using indwelling tunneled pleural catheters with vacuum assisted drainage~     systems. No current data exists regarding the efficacy, complications or rate of spontaneous~     pleurodesis when using indwelling tunneled pleural catheters and non-vacuum assisted drainage~     systems. This study is designed to evaluate an indwelling tunneled pleural catheter with a~     non-vacuum assisted drainage system for the management of recurrent malignant pleural~     effusions.~   "
11606|NCT03414892|"~     This is a phase I placebo-controlled study to assess safety, tolerability, pharmacokinetics~     and pharmacodynamics of Globalagliatin Hydrochloride (SY-004) after Multiple Ascending Doses~     in patients with Type 2 Diabetes Mellitus (T2DM).~   "
11607|NCT03414879|"~     This randomized double-blinded study is performed to compare ketamine versus lidocaine for~     nebulization for awake nasal fiberoptic intubation as regard efficacy and side effects.~   "
11608|NCT03414866|"~     This is a global, prospective non-interventional, multi-centre, post-market study of the~     Vascutek Thoraflex™ Hybrid system in patients with acute thoracic aortic syndrome,~     subacute/chronic dissection of the aorta and aortic aneurysm.~   "
11609|NCT03414853|"~     Computer-aided diagnostic software has been used to assist physicians in various ways.~     Text-based prediction algorithms have been trained on past medical records through data~     mining and feature analysis. Currently, all text-based machine learning prediction problem~     models have been built on extracted data with no research completed on free text based~     prediction algorithms. This study aims to determine the accuracy of a free text prediction~     algorithm in predicting the probability of appendicitis in patients presenting to the~     Emergency Department with abdominal pain and gastrointestinal symptoms.~   "
11610|NCT03414840|"~     Assessment of Change in AtheROSclerotic Plaque by Serial CCTA (ACROSS) is designed as a~     prospective observational study which aim is to demonstrate the effect of statins on coronary~     atherosclerosis, assessed by quantitative analysis of CCTA.~   "
11611|NCT03414827|"~     Recruitment of participants to the study takes place at the urological department at Zealand~     University Hospital, Roskilde, Feb. 2018-April 2018. 10 people with diagnosis of renal cancer~     should be recruited in phases 1. Subsequently, biological materials from 100 patients with~     kidney cancer will be used from the national Biobank. In phase 3, 10 patients will be~     recruited for the final gene test.~   "
11612|NCT03414814|"~     This is a single-arm, non-randomized multicentre phase 2 study in NSCLC patients with EGFR~     exon 20 insertion mutation, whose disease has progressed on standard chemotherapy.~   "
11613|NCT03414801|"~     To assess the reproducibility of the allergic response in the cat allergic subjects, measured~     as the change from baseline of the Total Nasal Symptom Score (TNSS) on the two challenge~     days.~   "
11614|NCT03414788|"~     The purpose of the study is to evaluate the PK, safety and tolerability of PF-06687234 and~     [124I]IB-PF-06687234 (simultaneously given) in subjects with moderate to severe Ulcerative~     Colitis. The study used PET-CT scan imaging to assess the distribution of PF-06687234 and~     [124I]IB-PF-06687234 over 24 and 72 hours in colon (inflamed and non-inflamed), plasma,~     colon, liver, spleen, kidney and small intestine.~   "
11616|NCT03414762|"~     A randomized controlled, parallel group, superiority, open-label, single-institution, Phase 3~     interventional clinical trial to evaluate clinical outcomes in obese gravidas undergoing~     elective cesarean delivery whose wounds were dressed with the PICO Negative Pressure Wound~     Therapy (NPWT) versus the standard dressing. We hypothesize that the PICO NPWT will reduce~     the incidence of surgical site occurrences and interventions and postoperative readmissions~     in obese women. The study will compare surgical site occurrences and surgical incision~     intervention incidence within 42 +/- 10 days post cesarean delivery in obese women who have~     the current standard-of-care dressing versus the PICO NPWT.~   "
11617|NCT03414749|"~     The focus of this study is to explore the effect of upper and lower extremity chiropractic~     adjustments (manipulation) as well as surface condition (hard surface vs rocker board) on~     multisegmental postural control as represented by postural sway. Using a rocker (tilt) board,~     the participant cannot stand still, but has to adjust posture continuously to maintain~     balance. Body sways are considered to be self-induced because the design of the rocker board~     creates a natural instability without any external perturbation. This task provides a~     self-driven sensorimotor condition in addition to amplifying the sway dynamics. Because the~     rocker board has only one degree of freedom of motion, anteroposterior and lateral sways were~     considered separately on the device. We had the following hypotheses. Hypothesis 1: Lower~     extremity adjustments will lead to reduced postural sway magnitude compared to upper~     extremity adjustments. Hypothesis 2: Lower extremity adjustments will reduce sway variability~     of the rocker board, trunk and head compared to upper extremity adjustments. Hypothesis 3:~     Lower extremity adjustments will facilitate the organization of sway behavior as assessed by~     the chaotic structure of sway.~   "
11618|NCT03414736|"~     Primary Objectives:~        -  Main study: To assess in overweight to obese subjects and type 2 diabetes mellitus~          (T2DM) patients not requiring anti-diabetic pharmacotherapy the safety and tolerability~          of 3 different dose escalation regimens of SAR425899 in terms of the relative and~          absolute frequency and severity of gastrointestinal (GI) adverse events (AEs).~        -  Six-month safety extension period: To assess the safety and tolerability of SAR425899~          after 6 months treatment at the maximum dose that was individually well tolerated during~          the main part of the study in terms of the relative and absolute frequency and severity~          of GI AEs.~      Secondary Objectives:~      Main study and 6-month study extension period:~      To assess in overweight to obese subjects and T2DM patients not requiring anti-diabetic~     pharmacotherapy:~        -  The effect of once-daily dosing of SAR425899 on body weight (BW), fasting plasma glucose~          (FPG), and hemoglobin A1c (HbA1c).~        -  Safety and tolerability.~   "
11619|NCT03414723|"~     Primary Objective:~      To evaluate the effects of multiple-dose ramipril on the steady state pharmacokinetic (PK)~     parameters of sotagliflozin and its main metabolite (sotagliflozin-3-O-glucuronide) in~     healthy male and female subjects.~      Secondary Objectives:~        -  To assess the effects of multiple-dose sotagliflozin on the PK of ramipril and its~          active metabolite (ramiprilat).~        -  To assess the safety and tolerability of multiple-dose sotagliflozin with and without~          multiple-dose of ramipril.~   "
11620|NCT03414710|"~     A parallel-group, non-blinded randomized controlled trial was conducted. Participants were~     uncircumcised heterosexual male sexually transmitted disease patients attending the four~     collaborative public sexually transmitted diseases clinics in three Chinese cities. Those who~     were known to be HIV positive were excluded. After completion the baseline face-to-face~     interview, 238 participants will be randomized 1:1 into the intervention group and the~     control group. Participants in the control group will receive a health education booklet~     introducing voluntary medical male circumcision. In addition to the health education booklet~     received by the control group, the intervention group watched a 10-minute video and received~     a brief counseling delivered by the clinicians. Participants will be followed up by telephone~     six months afterwards.~   "
11621|NCT03414697|"~     To preliminarily evaluate the efficacy and safety of umbilical cord-derived mesenchymal stem~     cells (UC-MSCs), and compare the efficacy of UC-MSCs administered through the intravenous,~     intrathecal, and intranasal routes, in the treatment of cerebral palsy in children.~   "
11622|NCT03414684|"~     This research study is studying a drug called Carboplatin with or without another study drug,~     Nivolumab as a possible treatment for triple-negative breast cancer that has spread to other~     parts of the body.~      The interventions involved in this study are:~        -  Carboplatin~        -  Nivolumab~   "
11623|NCT03414671|"~     A health care initiative will be implemented December 4, 2017 in the Newborn Intensive Care~     (NICU) setting in an attempt to reduce the length of stay (LOS) for premature infants after~     standardizing the definition and approach to a clinically significant cardiopulmonary event~     (CSCPE). We would like to compare LOS in infants born < 30 weeks gestation before and after~     standardization to see if LOS is reduced.~   "
11624|NCT03414658|"~     This research study is studying a combination of drugs as a possible treatment for breast~     cancer.~      The drugs involved in this study are:~        -  Group A: Trastuzumab (Herceptin) + Vinorelbine (Navelbine)~        -  Group B: Trastuzumab + Vinorelbine + Avelumab~        -  Group C: Trastuzumab + Vinorelbine + Avelumab + Utomilumab (PF-05082566)~   "
11625|NCT03414645|"~     The purpose of this Phase 1/2 study is to compare the safety and tolerability of four times a~     day (QID) dosing of a non-preserved topical ocular drop formulation of 10 vol/vol % and 30~     vol/vol % of FD hPL to vehicle control eye drops in patients with Dry Eye Disease (DED)~     secondary to Graft vs. Host Disease (GvHD).~   "
11626|NCT03414632|"~     To estimate the prevalence of transthyretin cardiac amyloidosis (TTR-CA) among Heart Failure~     with Preserved Ejection Fraction (HFpEF) patients with increased LV wall thickness in~     Southeast Minnesota using 99mTc-PYP single-photon positive emission computed tomography with~     computed tomography (SPECT/CT).~   "
11627|NCT03414619|"~     The investigators are examining whether difficulties with cognitive control (i.e., the~     ability to stop one's thought process and shift attention) is a common problem across three~     types of repetitive, negative thinking: obsessions (as seen in obsessive compulsive disorder,~     OCD), worries (as seen in generalized anxiety disorder, GAD), and ruminations (as seen in~     major depressive disorder, MDD).~   "
11628|NCT03414606|"~     In the project, investigators basically plan to test the difference in social behavior and~     social cognition between depressive patients and healthy individuals. To test this,~     investigators plan to use traditional or novel behavioral experiment paradigms to target~     various behaviors.~   "
11629|NCT03414593|"~     The purpose of this study was to investigate the preemptive effect of ultrasound guided~     popliteal scistic nerve block on postoperative acute pain in patients with bilateral hallux~     valgus.~      After induction of general anesthesia, the leg to be operated first is decided randomly.~     After the operation of one leg is completed, PSNB is performed on both legs with 0.2%~     Ropivacaine and surgery is started on the remaining legs.~      When the surgery is over, check to see which foot pain begins first, how strong the pain is,~     and whether there are any side effects.~   "
11630|NCT03414580|"~     The availability of noninvasive biomarkers for diagnosis and stratification of inflammatory~     bowel disease (IBD) courses is lacking. Thus, the aim of this study is to evaluated the~     accuracy of exhaled breath volatile metabolite analysis on diagnosis and stratification of~     patients with inflammatory bowel disease.~   "
11631|NCT03414567|"~     Smoking is associated with many adverse health effects like circulatory disorders, pulmonary~     diseases or heart diseases. It was also shown that smoking correlates with a significantly~     higher risk for miscarriage, preterm birth or a significantly decreased implantation rate or~     life birth rate, thus affects the chance to have children.~      Combustion of tobacco products results in more than 4.000 toxic and/or carcinogenic~     substances. Examples of such substances are the carcinogenic substance Benzo(a)pyrene or~     nicotine and its main degradation product cotinine. Although the adverse effects of these~     substances were analyzed in many biological systems (e.g. cell culture, mouse model systems),~     less is known about the bio-accumulation in human tissue, especially in ovarian tissue or the~     follicular fluid (FF).~      The aim of this study is therefore to analyze the bio-accumulation of nicotine, cotinine and~     Benzo(a)pyrene in the follicular fluid of women with the unfulfilled desire to have children~     undergoing an intracytoplasmic sperm injection (ICSI) treatment. The analysis will be~     performed using a sensitive gas chromatography-mass spectroscopy (GC) in a control group~     (non-smoker) and a study group (smoker). For each group, a correlation analysis between the~     amount of toxic and/or carcinogenic substances and the clinical outcome (e.g. clinical~     pregnancy rate, fertilization rate) will be performed. In combination with a patient~     questionnaire, it will be possible to analyze the risk of smoking, the bio-accumulation of~     toxic substances in the follicular fluid, and the chance to have children.~   "
11632|NCT03414554|"~     Direct acting antivirals (DAAs) are a novel and completely oral hepatitis C therapy . DAAs~     are used in most patients being treated for hepatitis C, including those with decompensated~     cirrhosis. This type of treatment has now completely replaced interferon-based therapy~     .Therapy of chronic hepatitis C with direct-acting antivirals (DAAs) is able to induce a~     sustained virological response (SVR) in over 85% of patients, even if liver cirrhosis is~     present. Cirrhotic patients should be closely monitored after treatment.HCC is thought to~     develop over time as the liver is exposed to inflammation and develops fibrosis. Thus, if~     DAAs can eliminate inflammation mediated by HCV, the risk of HCC should decrease. However,~     several centers have observed that this actually may not be the case. Tumor genesis occurs~     through a multistep, multifactorial process. Eliminating HCV-induced inflammation may not be~     enough to decrease risk of HCC.DAAs have provided an effective, well tolerated treatment for~     hepatitis C in patents with cirrhosis . However, several studies have shown unexpectedly high~     rates of recurrence of HCC in the early post DAAs treatment time period.~        1. Evalution of occurrence and risk factors for hepatocellular carcinoma (HCC) in patients~          with HCV-related liver cirrhosis after direct acting antiviral drugs (DAAs) therapy.~        2. To asses diagnostic value of novel markers in patients who developed hepatocellular~          carcinoma (HCC) after (DAAs)~   "
11633|NCT03414541|"~     The purpose of this randomised, double-blind, placebo-controlled, parallel group study is to~     assess the safety and efficacy of orally administered DS102 capsules versus placebo in the~     treatment of adult patients with Chronic Obstructive Pulmonary Disease (COPD).~   "
11634|NCT03414528|"~     Analysis of DNA samples of patients with molecularly undetermined PID by whole exome/genome~     sequencing.~      Transcriptome analysis of patients with molecularly undetermined PID.~   "
11635|NCT03414515|"~     The purpose of this observational study is to evaluate the performance and safety of~     endovascular treatment with stenting (Optimed Sinus Superflex 635 or Qualimed Pontos-pp) or~     balloon angioplasty (Cardionovum Legflow or Optimed Nylotrack .035 + .018) according to~     current practice. The goal of the study will be achieved by assessing binary restenosis with~     duplex ultrasound, peri- and postoperative complications, technical success, target lesion~     revascularization, amputation and clinical outcome.~   "
11636|NCT03414502|"~     This is an open-label, prospective study of methotrexate in patients with early rheumatoid~     arthritis (RA) designed to characterize the subset of RA patients that respond best to~     methotrexate monotherapy. Eligible patients will be adults with RA who are naïve to prior~     methotrexate or combination disease-modifying antirheumatic drug (DMARD) therapy. Patients~     will be started on methotrexate at 15 mg once weekly, with the dose escalated to 20 mg once~     weekly at 8 weeks for patients not in remission. Patients will be assessed with joint counts~     and laboratory monitoring at study entry, 8 weeks, and 16 weeks. Primary endpoint will be~     achievement of ACR 50 (American College of Rheumatology 50) criteria. Investigators will~     collect serum for rheumatoid factor (RF) and anti-CCP antibody isotyping and, in patients who~     sign a separate consent, DNA for genotype analysis. This should allow Investigators not only~     to evaluate the efficacy of methotrexate monotherapy but also to identify predictors of a~     good therapeutic response and evaluate the tolerability of a more aggressive dosing regimen.~   "
11637|NCT03414489|"~     This is an expanded access program (EAP) for eligible participants who do not qualify for~     participation in, or who are otherwise unable to access, the ongoing clinical trial ABC-108.~     This program is designed to provide access to ABC294640 (Yeliva ®) for treatment of~     cholangiocarcinoma (CCA) prior to approval by the local regulatory agency. Availability will~     depend on territory eligibility. Participating sites will be added as they apply for and are~     approved for the EAP. An oncologist must decide whether the potential benefit outweighs the~     risk of receiving an investigational therapy based on the individual patient's medical~     history and program eligibility criteria.~   "
11638|NCT03414476|"~     In this study, the investigator will try to highlight the presence of carbonyl compounds in~     the hair follicles of women with telogen effluvium (ET) linked to stress of various origins~     (fatigue, infectious diseases, emotional stress ...).~   "
11640|NCT03414450|"~     This study evaluates the use of ETC-1907206 in combination with dasatinib in certain types of~     blood cancers. The first phase of the study (1A) is designed to find the highest tolerated~     dose of ETC-1907206, while the second phase (1B) will assess the safety and tolerability of~     the recommended dose of ETC-1907206. ETC-1907206 has been designed to block the activity of~     an enzyme of the body known as Mnk kinase, which is thought to be involved in the development~     of a variety of cancers.~   "
11641|NCT03414437|"~     This is a Long Term Follow Up study to eRADicAte, an open label study designed to examine the~     effects of Radium Ra 223 dichloride with concurrent administration of Abiraterone Acetate~     plus Prednisone Castrate-Resistant (Hormone-Refractory) Prostate Cancer subjects with~     symptomatic bone metastasis.~   "
11642|NCT03414424|"~     Most spinal cord injuries are anatomically incomplete - some nerve circuits remain intact,~     even if the individual cannot feel or control them. Activating spared nerve circuits may~     improve functional recovery.~      With this goal, the Investigators have developed a form of electrical stimulation over the~     cervical spinal cord that can activate muscles in both hands simultaneously and comfortably.~     This technique, called cervical electrical stimulation (CES), works at the skin surface - no~     surgery or other invasive procedures are required.~      The long-term goal is to use CES to strengthen residual circuits to hand muscles after SCI.~     Regaining control over hand function represents the top priority for individuals with~     cervical SCI.~      In the current study, the Investigators first need to better understand how CES works. In the~     first half of this study, the Investigators will take a systematic approach to determining~     how CES interacts with other circuits in the spinal cord and the brain. In the second half of~     the study, the Investigators will test combinations of CES with active hand and wrist~     movements to find ways to enhance physical movement with CES.~      These experiments will improve understanding of electrical stimulation in SCI, and may set~     the table for future treatments to prolong any short-term benefits observed in this study.~   "
11643|NCT03414411|"~     The purpose of this study is to follow a cohort of HIV-infected adults who have alcohol~     and/or drug use to: 1) test the associations between alcohol (and illicit drugs and~     polypharmacy (multiple prescribed medications)) and falls (fractures secondarily), and~     whether frailty mediates these associations; and 2) test the associations between alcohol~     (and illicit drugs and polypharmacy) and utilization (emergency department use and~     hospitalization for falls and fractures), and whether frailty mediates them.~      To achieve the stated aims the investigators will expand (to 400) and continue to follow an~     existing prospective cohort (The Boston ARCH Cohort) of adults with HIV infection and a high~     prevalence of exposure to alcohol, other drugs, and polypharmacy. The Boston ARCH Cohort is a~     longitudinal cohort (1-3.5 years of follow-up) of 250 HIV-infected men and women with current~     substance dependence or ever injection drug use that have a spectrum of alcohol use.~   "
11644|NCT03414398|"~     The objective of this study is to determine what influences the patient and caregiver~     perception of care, and if this perception associates with the percentage of and what quality~     metrics are being met and outcomes. The investigators also plan to capture the cost of~     providing quality metrics and the cost of monitoring adherence to quality metrics.~   "
11645|NCT03414385|"~     The proposed project will examine how exercise counteracts metabolic disorders and type 2~     diabetes through regulating gene expression. The project is highly relevant to public health~     because of the global pandemic of diabetes, obesity, and associated metabolic syndromes as~     well as the well-known metabolic benefit of physical exercise in correcting these disorders.~   "
11646|NCT03414372|"~     Tough Talks is a virtual reality based HIV disclosure intervention that allows HIV+~     individuals to practice disclosing to romantic partners. Tough Talks allows participants to~     have the opportunity to practice disclosing using a variety of strategies and experience~     different outcomes including acceptance, confusion, lack of HIV knowledge, and rejection.~   "
11647|NCT03414359|"~     Regional anesthesia is commonly used for elective and emergency cesarean delivery. It~     provides numerous safety advantages when compared to general anesthesia for both the mother~     and fetus1. Epidurals also have the added benefit of being able to provide pain relief~     throughout labor and in the event of cesarean delivery, epidural analgesia can be extended~     to provide surgical anesthesia. Numerous studies have been performed to assess the onset~     times of various local anesthetics when administered through an epidural catheter. Attempts~     to reduce anesthetic onset time and improve the quality of intraoperative analgesia have been~     attempted by using different local anesthetic solutions and by the addition of other drugs to~     the epidural solution (such as epinephrine, fentanyl and sodium bicarbonate).~   "
11648|NCT03414346|"~     As a therapeutic modality, cryotherapy is highly used for soft tissue damage control during~     acute and subacute stages. Cryotherapy is able to reduce pain, inflammatory condition, muscle~     spasm, nerve conduction, metabolic rate, edema formation and to prevent secondary hypoxic~     injury. These effects are due to the heat conduction, passing from tissue to different~     cryotherapy modalities, leading to tissue temperature reduction.~      The diversity of cryotherapy modalities in clinical practice, like crushed-ice packs, frozen~     food, gel packs and wetted ice packs, are widely explored by studies. To achieve anesthesia~     by cryotherapy it's settled that the skin temperature must reach 13,6 degrees celsius (ºC).~     Ice packs are the most effective modality of cryotherapy when placed directly on the skin,~     this effectiveness is accentuated when ice packs are associated with water. To improve the~     contact area the pack must be wrapped.~      Even though wetted ice packs are the most effective modality, there are few studies~     approaching it. There aren't studies analyzing an ideal percentage of water to ice in this~     modality either. Also, it isn't observed if the amount of water interferes on the conduction~     of the heat from the skin to the ice pack, and in rewarming time. Besides neither of the~     studies measures the amount of pain during cryotherapy application, and if there was any~     difference between wetted ice packs, and ice packs isolated.~      Therefore, the purpose of this study is to analyze the most effective cryotherapy modality~     for reducing skin temperature, rewarming time, and the amount of discomfort during the~     application.~   "
11779|NCT03412630|"~     This phase II trial studies how well computed tomography perfusion imaging works in~     predicting outcomes in patients with ovarian, fallopian tube, or primary peritoneal cancer~     who are receiving bevacizumab. Computed tomography perfusion imaging monitors the effects of~     the drug treatment on the blood flow to the tumor, and may help to predict whether a certain~     drug therapy is likely be successful in a patient with ovarian, fallopian tube, or primary~     peritoneal cancer.~   "
11649|NCT03414333|"~     To test the hypothesis that GLP1 can exert favourable effects on multiple aspects of brain~     function. To this purpose, the investigator determine whether chronic increase in GLP1~     concentration as it occurs after bariatric surgery (Roux-en- Y Gastric Bypass) is associated~     with improvement in:~        -  cognitive function measured by Mini Mental State Examination (MMSE) and Mental~          Deterioration Battery(MDB).~        -  brain glucose metabolism measured by FDG-CT/PET~        -  neuroplasticity measure by binocular rivalry and saccadic adaptation tests in morbid~          obese subjects. In order to discern the effect of GLP1 irrespective of changes in the~          metabolic milieu the investigator will test whether short-term GLP-1 infusion can~          modulate the same parameters in healthy subjects.~   "
11650|NCT03414320|"~     The adoption of bolus calculators has been limited by the slow speed of the current trial and~     error approach. The goal of this project is to automate the determination of patient specific~     insulin pump parameters based on current automatic electronic logbooks of glucose~     measurements, carbohydrate intake, and insulin usage, by means of a mathematical model. More~     specifically, the investigators are interested in computing the carbohydrate to insulin ratio~     (CIR) and insulin sensitivity factor (ISF), which are the main parameters of bolus~     calculators.~      The present study is a proof-of-concept, open label, single arm clinical trial to validate~     the new method and refine both the mathematical model and the numerical techniques in~     well-regulated and disciplined type 1 diabetic subject.~      The study is a trial of the selected underlying mathematical model and the associated~     algorithms to simulate the glucose values of a patient with uncertain meal-data.~   "
11651|NCT03414307|"~     Non-traumatic intracerebral hemorrhage (ICH) affects approximately 100,000 Americans yearly.~     Up to 30-50% of ICH is fatal, and those patients who survive are often left with significant~     neurologic dysfunction. In the past, medical management (e.g., control of hypertension,~     reversal of antiplatelet or anticoagulants) had been the most effective treatment for these~     patients, given the morbidity and mortality associated with open surgical treatment for~     evacuation of ICH. However, recent trials have demonstrated that minimally invasive~     stereotactic neurosurgical procedures to evacuate ICH are safe and result in improved~     outcomes for these patients.~      Initial attempts to evaluate the efficacy of surgical evacuation of ICH found no significant~     difference between medical management and standard craniotomy for surgical evacuation.~     Indeed, open surgery was often discouraged for these patients due to the significant~     morbidity and mortality associated with the surgical procedure itself. However, research has~     demonstrated that minimally invasive, image guided stereotactic frame-based and frameless~     methods are effective and safe for the placement of catheters for clot aspiration and~     fibrinolytic therapy of ICH in the basal ganglia and other deep seated regions. Larger~     randomized controlled trials have demonstrated that these minimally invasive approaches also~     offer clinical benefit for these patients.~   "
11652|NCT03414294|"~     This is a Phase 1 study designed to explore the safety, tolerability and pharmacokinetics of~     K-755 following oral administration to healthy male and female volunteers.~   "
11653|NCT03414281|"~     This trial is a prospective, randomized, single-center, open-label, parallel-arm,~     blinded-analysis trial, the objective of which is to evaluate the effect of transmuscular~     quadratus lumborum block (TMQLB) in the pain relief and quality of recovery in laparoscopic~     renal surgery compared with thoracic paravertebral block (TPVB).~   "
11654|NCT03414268|"~     Prospective, double-blinded, randomized controlled trial of the micronized dHACM injection as~     compared to the saline placebo injection in the treatment of plantar fasciitis~   "
11655|NCT03414255|"~     Prospective, Double-Blinded, Randomized Controlled Trial of the Micronized dHACM Injection as~     Compared to Saline Placebo Injection in the Treatment of Achilles Tendonitis~   "
11656|NCT03414242|"~     The overall objective is to provide an onsite diagnosis with subsequent return to play~     criteria, as well as, lower the risk of traumatic brain injury by primary prevention through~     cervical spine neuromuscular control and vision training. The central hypothesis is that~     improved understanding of neurocognitive measures and function will provide improved~     diagnosis of concussion and help reduce the incidence of subsequent sports-related injury.~   "
11657|NCT03414229|"~     The purpose of this study is to test any good and bad effects of the combination therapy of~     epacadostat and pembrolizumab and to determine how well the combination therapy works in the~     treatment of patients with sarcoma.~   "
11658|NCT03414216|"~     100 consenting subjects with Texas grade 1a diabetic foot ulcers will be randomized to~     surgical offloading or non-operative offloading.~   "
11659|NCT03414203|"~     This study aims to compare the effects of transcranial direct current stimulation on the~     clinical and cognitive function in patients with chronic migraine.~   "
11660|NCT03414190|"~     The study is a two-arm, parallel, randomized clinical trial. The purpose of the study is to~     evaluate the effectiveness of automated mobile phone text message-based intervention for~     secondary prevention after acute coronary syndrome hospitalization. Text messages will~     include information about lifestyle modifications, medication adherence and cardiovascular~     risk factor control. The participants will be randomized into intervention and control groups~     in a 1:1 ratio. The intervention group will receive 4 pre-designed and semi-personalized text~     messages per week in addition to usual care for 6 months, while the control group will~     receive usual care.~   "
11661|NCT03414177|"~     This study will conduct a 12-month randomized trial with 84 pediatric patients (aged 6-18~     years) with persistent asthma to compare outcomes among patients with follow-up visits~     managed via telemedicine (TM) vs. in-person (IP) visits.~   "
11662|NCT03414164|"~     Proanthocyanidins are a class of polyphenols found in a variety of plants that have~     antioxidant activity in vitro, which is stronger than vitamin C or vitamin E.~      Several studies have been performed evaluating the administration of antioxidant therapy in~     the form of oral antioxidant supplementation or in vitro addition of antioxidant to culture~     media during assisted reproductive techniques (ART).~      However, the impact of in vitro addition of proanthocyanidins to semen has not been studied~     yet. The research question evaluated in the current study was whether semen samples of~     infertile men supplemented or not with procyanidine immediately after their production,~     differ in semen parameters, sperm DFI.~   "
11823|NCT03412058|"~     This is a prospective cohort study which aims to identify predictive factors of response to~     PD-1 and PD L1 antagonists authorised for use in France in treatment of melanoma, NSCLC, or~     HNSCC.~   "
11663|NCT03414151|"~     Antipsychotic (AP) medications are currently the cornerstone of treatment for schizophrenia~     (SCZ), with off-label prescription rapidly increasing in youth, with an established two-fold~     increase in standardized mortality ratio attributable to cardiovascular disease in this~     population. However, APs have been associated with common and serious metabolic adverse~     effects including weight gain and diabetes, to which youth are disproportionally vulnerable.~     The Gut Microbiome (GMB) has been suggested as a potential target warranting further study as~     a mechanism of AP induced weight gain and has also been linked directly with cognition and~     behavior. It is hypothesized that there will be changes in the gut microbiome overtime with~     treatment correlated with metabolic measures and that APs will produce changes in glucose~     tolerance, insulin sensitivity, adipokines, glucagon like peptide (GLP)-1, lipids, fasting~     glucose, body weight, and cognition.~   "
11664|NCT03414138|"~     Mindfulness meditation has been shown to reduce pain in experimental and clinical settings,~     and the neural mechanisms underlying this analgesia are distinct from that of placebo related~     beliefs in the utility of the meditation. Although previous studies have identified potential~     cortical and sub-cortical targets responsible for mediating these effects, the connectional~     relationships between them remains largely unexplored. The present study will use~     blood-oxygen-level dependent (BOLD) neuroimaging to assess functional connections supporting~     mindfulness meditation.~   "
11665|NCT03414125|"~     This is a pragmatic, randomized, controlled trial comparing whether a mailed outreach~     intervention offering patients who are not up-to-date with colorectal cancer (CRC) a choice~     of completing a home Fecal Immunochemical Test (FIT) test or scheduling a screening~     colonoscopy increases CRC screening completion compared to a mailed FIT kit outreach program~     (which does not offer an explicit choice of screening modality). The trial will be conducted~     in a racially and socioeconomically diverse cohort of patients served by an integrated safety~     net delivery system that has a FIT first population health screening strategy. All patients~     will also have access to whatever CRC screening is recommended through usual visit-based~     care.~   "
11666|NCT03414112|"~     This study will use a randomized, controlled, double-blind design involving the~     administration of intranasal oxytocin (INOT) or placebo to adults with anorexia nervosa,~     restricting subtype and age-matched controls prior to neuroimaging to assess the impact on~     frontolimbic brain activity in response to socioemotional stimuli as well as eating behavior~     in a test meal paradigm.~   "
11667|NCT03414099|"~     The study aim is to evaluate potential analgesic properties of ketum using the cold pressor~     task.~   "
11668|NCT03414086|"~     Comparing the clinical effects of Acthar Gel before and after treatment and compare it to~     patients with inactive disease.~   "
11669|NCT03414073|"~     Removal and prevention of formation of dental plaque biofilms is the cornerstone of current~     hygiene regimens to prevent, reduce or even reverse the gingival and periodontal disease~     condition. In such endeavors of mechanical plaque removal, tooth-brushing and use of dental~     floss play an important role. Gomes et al have presented a modification in the use of knotted~     floss in wider embrasure areas. The modification in the dental floss has been done so as to~     increase the effective width of the floss. The purpose of this study is to compare the~     reduction of the clinical signs of plaque accumulation, gingival inflammation, gingival~     bleeding and gingival trauma in the area the knotted floss technique has been utilized versus~     the area where conventional flossing or interdental brush has been utilized in Type II~     gingival embrasures. Patients' acceptability of the knotted flossing technique will also be~     evaluated.~   "
11670|NCT03414060|"~     This study examines the feasibility and acceptability of the vaginal menstrual cup for~     short-term management of vesicovaginal fistula (VVF) among 11 women seeking treatment at a~     health facility in Ghana. The repeated measures design utilizes a 2-hr pad test to compare~     urinary leakage with and without the insertable cup, a questionnaire on acceptability and~     perceived effect is administered and a clinical exam is completed.~   "
11671|NCT03414047|"~     The purpose of this study is to evaluate the efficacy and safety of prexasertib in women with~     platinum-resistant or refractory recurrent ovarian cancer.~   "
11672|NCT03414034|"~     The purpose of the phase 2 study is to determine whether PCM-075 given orally once daily for~     5 consecutive days every 21 days is safe and tolerable in adult patients with Metastatic~     Castration-Resistant Prostate Cancer who have disease progression while receiving abiraterone~     acetate (abiraterone) and prednisone therapy, and to observe the effects of PCM-075 in~     combination with abiraterone and prednisone on disease control.~   "
11673|NCT03414021|"~     Since 2017, a revolution began in the departments of nuclear medicine, with the routine use~     of gamma-cameras with semiconductor. These gamma-cameras (which obtained the CE-marking in~     2016), offer a technological breakthrough by providing an additional information. They allow~     to quantify for the 1st time in clinical routine conditions, the quantity of radioactivity,~     by means of a SUVspect, in a volume of interest, while respecting the recommendations of~     best practice of the learned societies of French nuclear medicine (SFMN), European (EANM) and~     American (SNM), without injection of tracer nor acquisition or additional irradiation. The~     SUVspect is therefore an indicator of the quantity of tracer in a given volume of~     acquisition.~      Until now, the interpretation criteria of scintigraphies are based on the homogeneity of~     distribution of a tracer in the explored organ (for single organs such as the heart or the~     thyroid, for example) or in the asymmetry of distribution of the tracer (for the double~     organs, such as the kidney or the joints).~      This new gamma-camera allows to study the distribution of the radio-tracers in list mode,~     allowing to retrospectively reconstruct the images in various ways (for example, by modifying~     the size of the matrix of acquisition, the energy windows, the time of acquisition).~     Therefore, we can simulate and propose modifications in current procedures.~      Every patient referred to our department of nuclear medicine to undergo a scintigraphy with a~     tracer of nuclear medicine (with a marketing authorization) can, while benefiting from an~     examination by this gamma-camera, to be the object of this study, and to profit from this~     additional information.~      So, without changing the diagnosis or the usual care, we wish to take advantage of this~     additional information to improve the criteria of interpretation of our examinations.~      This possibility being new, there is no available bibliography (our department is the 5th~     department of nuclear medicine in Europe to equip itself with this large field-of-view~     gamma-camera CZT, the DNM 670, made by General Electric), while 2961 articles speak about the~     SUVmax (in PET) in Pubmed.~   "
11674|NCT03414008|"~     The primary objective of this trial is to investigate the safety and tolerability of BI~     1291583 in healthy male subjects following oral administration of single rising doses.~      Secondary objectives are the exploration of the pharmacokinetics (PK) including dose~     proportionality and pharmacodynamics (PD) of BI 1291583 after single dosing.~   "
12141|NCT03407898|"~     Mallampati score > 3 generally indicate difficult airway and difficult intubation. Most~     anesthesiologist usually use this score system to predict difficult airway management.~     Different laryngoscopes may be useful in management of difficult airway. This study designed~     to compare different videolaryngoscopes in intubation success in patient of Mallampati~     score>3.~   "
11675|NCT03413995|"~     The aim of this research is to find out if the study drug rucaparib leads to lowering of PSA~     levels in men with metastatic prostate cancer that has not yet been treated with androgen~     deprivation therapy (also referred to as metastatic hormone sensitive prostate cancer) and~     who have an inherited mutation in a gene involved in repairing DNA damage. The research will~     also examine if rucaparib is safe in individuals with metastatic prostate cancer.~      Prior research studies have shown that drugs like rucaparib can be of benefit to patients~     with advanced metastatic prostate cancer who are resistant to androgen deprivation therapy~     AND who carry a mutation in a DNA repair gene. We are studying if rucaparib will be an~     effective treatment for these patients earlier in their treatment course (for example, prior~     to the start of medicines that lower testosterone level). It is unknown whether rucaparib~     will have the same benefit in men with metastatic prostate cancer carrying a mutation in a~     DNA repair gene, prior to the use of medicines that lower your testosterone level.~   "
11676|NCT03413982|"~     The purpose of this study is to create a registry, which is a bank of information about~     patients who have had similar medical conditions and treatments. The registry will be used by~     researchers to learn more about long term outcome of patients with bladder cancer, how~     bladder cancer tissues are related to tumor development, recurrence and survival.~   "
11677|NCT03413969|"~     The purpose of this study is to determine whether a standardized application of a~     physician-oriented CREATION Health curriculum is associated with reductions in burnout and~     perceived stress and improvements in well-being and empathy~   "
11678|NCT03413956|"~     The real-world observational study was designed to explore the odd factors of lymph~     metastases in the patients with T1 non-small cell lung cancer, the effects of clinical~     characteristics on lymph metastases, and compare the differences in lymph metastases in the~     subgroups.~   "
11679|NCT03413943|"~     The purpose of this study is to test the influences of gaze training (GT) on the acquisition~     of laparoscopic surgical skills. For this purpose, the investigator will compare variants of~     GT in the second of 2 experiments. These questions will be evaluated using the validated~     Fundamentals of Laparoscopic Surgery (FLS) module 1, with the overall goal of developing a~     surgical training curriculum that achieves expert level skill in an expedited timeframe. This~     research provides a novel approach to general surgery training that has the potential to~     reduce the amount of time and repetitions required to achieve expert laparoscopic skills.~   "
11680|NCT03413930|"~     This study is designed to evaluate the short-term and long-term results after transanal total~     mesorectal excision (TaTME) for the resection of mid and low rectal cancer compared with~     laparoscopic total mesorectal excision（LaTME）.~   "
11681|NCT03413917|"~     The primary objective of this study is to determine whether there are markers in the tissue~     of atonic uteri, and in the patients' plasma that would help identify patients likely to~     suffer postpartum hemorrhage due to uterine atony. We also will attempt to identify the~     cause(s) of uterine atony that might suggest mechanisms to prevent and manage it.~   "
11682|NCT03413904|"~     This study is designed as a prospective, multi-center, randomized, open-labelled, parallel~     group, non-inferiority trial. The aim of this study is to evaluate the TaTME technique~     compared with conventional laparoscopic rectal surgery, focusing on, anastomotic dehiscence,~     conversion rate to open surgery, hospital stay and long-term functional outcomes.~   "
11683|NCT03413891|"~     In patients treated with direct oral anticoagulants, bleeding events during or after tooth~     extraction can lead to unscheduled interruption of the antithrombotic treatment and a~     potential increased risk of thrombo-embolic events. Therefore, an optimal strategy to~     minimize bleeding events after tooth extractions is required. In this study, the~     investigators want to assess whether adding tranexamic acid mouthwash reduces the number of~     bleeding events in patients treated with direct oral anticoagulants and undergoing a tooth~     extraction.~   "
11684|NCT03413878|"~     The aim of the study is to investigate respiratory parameters of a person in the simulated~     avalanche snow and consequent use of the measured data for development of a~     mathematical-physical model of breathing during increasing hypercapnia in the avalanche.~   "
11685|NCT03413865|"~     This randomized, open label study will evaluate a nurse and pharmacist led clinic conducted~     remotely from Grand River Regional Cancer Centre at Grand River Hospital (GRRCC/GRH) using~     OTN teleconferencing as a platform for patients with prostate cancer receiving oral~     chemotherapy agents.~   "
11686|NCT03413852|"~     The objective of this study is to further establish that SQUID, an alternative liquid embolic~     agent with specific properties, is a safe and effective alternative in bAVM endovascular~     treatment strategy available to date. Therefore, the performance of SQUID will be documented~     and its safety of use will be confirmed in current practice.~   "
11687|NCT03413839|"~     This is a pilot study to lead to a larger prospective, randomized, controlled study of older~     adult (ages 50 and older) spinal patients with thoracolumbar/lumbar scoliosis evaluating~     improvement with physiotherapeutic scoliosis-specific exercise (PSSE) compared to traditional~     low back physical therapy (PT).~   "
11688|NCT03413826|"~     The objective of this project is to determine the biological, neurobehavioral, and behavioral~     compensatory responses to exercise training-induced energy deficits in overweight to obese~     men and women. Participants will engage in exercise to expend 3,000 kcal per week for 12~     weeks and have body composition assessed via DXA before and after the exercise intervention.~     Accumulated energy balance (weight loss converted to kcal) will be compared to exercise~     energy expenditure to determine each individual's level of compensation, termed compensation~     index. Predictors of compensation index that will be assessed will include hunger/satiety~     hormone concentrations at rest and in response to a meal, reward driven feeding, changes in~     metabolic rate, and energy intake throughout the intervention. Exercise reinforcement and~     physical activity will also be assessed as a separate aim to determine if exercise~     reinforcement can be increased and if this can promote greater habitual physical activity~     after the intervention has ceased.~   "
11689|NCT03413813|"~     The safety and efficacy of percutaneous coronary revascularization has been progressively~     increasing since its inception, and the problem of restenosis has been minimized.~      The efficacy and safety data of the Magmaris stent are quite high, in selected cases.~      The objective is to evaluate the efficacy and safety of the bioabsorbable stent MAGMARIS in~     the percutaneous treatment of severe coronary disease (in vessels between 2.7mm and 3.75 mm)~     in routine clinical practice in poorly selected populations.~   "
11690|NCT03413800|"~     Multiple Myeloma (MM) is a morbid disease which can only be cured with an allogeneic~     hematopoietic stem cell transplant (HSCT). Approximately 50% of allotransplanted patients~     will relapse, with a median survival of 5 years. Better approaches to improve disease control~     at relapse, while decreasing toxicity, are urgently needed.~      Relapse after allogeneic transplant is a failure of the graft versus MM effect (GvMM). DLIs~     can be used to control disease following relapse, but the optimal dose, schedule of~     administration and drug association remain elusive, while the immunosuppression found in MM~     patients can compromise their effect. One reason for immunotherapy failure relates to the~     immunological environment: as much as myeloma cells depend on their microenvironment to~     survive and proliferate, the immunotherapeutic effect of allogeneic HSCT depends on both~     systemic and local immunological status to be efficacious. Immunomodulatory drugs such as~     Lenalidomide (Len) have been tried in various settings after allogeneic transplantation with~     the aim to reverse immunosuppression and stimulate the GvMM, but if and how Len influences a~     GvMM and thereby promotes an immunotherapeutic success remained uncharacterized. Therefore, a~     deeper understanding of the immunological environment in MM patients is needed in order to~     establish and / or restore a potent GvMM effect.~      This study proposes the powerful combination of the two following goals, one clinical and one~     biological :~        1. Clinical: The investigators propose a two-step treatment using first Len in association~          with Dexamethasone (Dex), followed by Donor Leukocytes Infusions (DLIs) to offer an~          optimal disease control strategy in relapsed patients. The cytoreductive and~          immunomodulatory effects of Len is expected to induce a permissive immunological~          environment for the immunotherapeutic activity of DLIs to develop, while the association~          with Dex will lessen the risk of graft-versus-host disease (GVHD). This treatment~          combination has the potential to further improve depth of myeloma response, delay~          myeloma progression and improve patient survival.~        2. Biological: In an attempt to gain knowledge on how the GvMM behaves in MM patients~          post-relapse after having received a combined treatment of Len/Dex/DLIs, the~          investigators propose to characterize the immune environment of their bone marrow (BM)~          using both minimal residual disease (MRD) assessement by flow cytometry and an unbiased~          analysis of the transcriptome at various time points.~   "
11691|NCT03413787|"~     The freezing of gait (FOG) is one of the disabling symptoms in Parkinson's disease. The~     diagnosis and assessment of the FOG may be diffucult, but it is absolutely necessary. The aim~     of this study was to develop a Türkish version of the freezing of gait questionnaire (FOG-Q)~     and assess the validity and reliability of this Türkish version.~      The researchers firstly communicated with the developers of the FOG-Q. The permission for~     Turkish version was received by Giladi. Then, the FOG-Q will be adapted into Türkish using~     forward-backward translation by three native Türkish-speaking forward translators and one~     native English-speaking backward translator. The internal reliability of the FOG-Q Türkish~     version will be assessed using Cronbach's alpha, and item analyses will be conducted by~     examining the effect on Cronbach's alpha of excluding each of the six FOG-Q items~     individually. The test-retest reliability will be assessed using intraclass correlation~     coefficient (ICC).~      Convergent validity will be evaluated by means of Spearman rank correlation coefficient (rs).~     In this section will be determined the correlation between the FOG-Q scores and scores of the~     UPDRS motor section , Berg Balance Scale, Timed up and go test, Falls Efficacy Scale and~     Hoehn and Yahr stages.~   "
11692|NCT03413774|"~     The study group included 910 women who attended Fayoum university hospital gynecology~     outpatient clinic for postabortive evaluation. The control group included 940 women attended~     outpatient clinic for any other procedure or complaint~   "
11693|NCT03413761|"~     This study will investigate the null hypothesis that use of antioxidant supplements during~     adjuvant chemotherapy will have no impact on toxicities and disease-free, as well as overall,~     survival, and also evaluate the role of polymorphisms in genes related to oxidative stress in~     relation to treatment outcomes.~   "
11694|NCT03413748|"~     All participants will be randomized at elective cesarean section to either irrigation with~     500 to 1000 ml of warm normal saline after closure of visceral peritoneum or non irrigation~   "
11695|NCT03413735|"~     This study is focused on assessing gastrointestinal-level improvements by which green tea~     limits metabolic endotoxemia. It is expected that catechin-rich green tea will improve gut~     barrier function to prevent endotoxin translocation and associated low-grade inflammation.~     Outcomes will therefore support dietary recommendations for green tea to alleviate~     obesity-related inflammatory responses. Specifically, the study is expected to demonstrate~     that a green tea confection snack food can attenuate metabolic endotoxemia in association~     with restoring gastrointestinal health.~   "
11696|NCT03413722|"~     The purpose of this study is to learn if changing from Tacrolimus to Everolimus will improve~     cognitive function by having less effect on brain blood flow.~   "
11697|NCT03413709|"~     The Fathers' Support Center, in partnership with the Brown School Evaluation Center at~     Washington University in St. Louis, seeks to evaluate the impact of their New Pathways to~     Responsible Fatherhood Family Formation Program (NPFF). The investigators are most interested~     in quantifying the added benefit of parenting, father-child engagement, and father well-being~     curriculum compared to course content containing 80 hour economic stability material only.~     The impact evaluation will answer four key outcome and implementation specific questions~     using a mixed methods approach. Participants will be randomly assigned to one of two groups~     (full program or 80 hour economic stability curriculum only) and tracked for the duration of~     the program. The impact evaluation tools include a set of validated instruments and will be~     administered to participants at baseline and again at three and twelve months after~     completion of the program. Performance measurement data will also be included in our~     analysis. Investigators hypothesize that participation in the full program will have a~     greater effect on key outcomes than the economic stability curriculum, a similar number of~     families will be reached by each condition, and that there will be minimal variability in~     retention rates across groups.~   "
11698|NCT03413696|"~     A clinical observational study for patients with HIV co-infected with hepatitis C that~     investigates the levels of their health literacy, hepatitis C and HIV knowledge. Participants~     will complete a one-time assessment of these studied domains and categorized in three groups~     defined by their hepatitis C treatment referral status: not-referred, referred-attended,~     referred and no-show.~   "
11699|NCT03413683|"~     Frailty has been proposed as a measure of biological (as opposed to chronological) aging. In~     this study the investigators plan to: (1) measure frailty in a cohort of older HIV-infected~     individuals in Hong Kong, and its association with mortality and quality of life; (2)~     identify risk factors predictive of development of frailty in HIV-infected individuals in~     Hong Kong; and (3) determine the outcomes of HIV-infected individuals in Hong Kong with and~     without frailty.~      The following assessment will be done:~        1. Physical examination including measuring height, weight, hip and waist circumference.~        2. Grip strength, chair stand test, gait speed test, balance tests, and neurocognitive~          tests~        3. Geriatric syndromes, screening for depression, disability and quality of life.~        4. Blood tests during fasting state to measure metabolic parameters.~      This is a prospective longitudinal observational study that lasts for 10 years.~   "
11701|NCT03413657|"~     The goal of this study is to identify in patients requiring active fluid resuscitation and~     mechanical ventilation for circulatory shock, can a controlled increase in intrathoracic~     pressure (either by positive-end expiratory pressure (PEEP) or tidal volume (TV)) predict~     responsiveness to additional fluid resuscitation.~      We hypothesize that a temporary, physiologically-safe increase in positive-end expiratory~     pressure (PEEP) and/or a temporary increase in tidal volume (from 6 cc/kg predicted body~     weight (PBW) to 8 cc/kg PBW) in patients requiring invasive mechanical ventilation will~     predict fluid responsiveness based upon an assessment of the change in pulse pressure and~     stroke volume variation.~   "
11702|NCT03413644|"~     Multi-center study of specimens from subjects presenting to the flow cytometry laboratory as~     part of their standard of care for hematological diseases work-up.~   "
11703|NCT03413631|"~     Objective: This randomized and controlled trial was aimed at exploring the effect of a new~     mentalization-focused 4D interactive ultrasound and a week-by-week pregnancy diary~     intervention with substance-abusing pregnant women.~      Method: Pregnant women referred to the hospital maternity outpatient clinic from primary~     health care due to substance abuse were recruited to participate in a randomized and~     controlled study. At admission, a psychiatric nurse offered all eligible women an opportunity~     for participation. A written informed consent was obtained from all participants included in~     the study. The participants were randomized into the intervention and control groups using a~     computer-generated block-randomization with block size of four. A separate randomization~     assignment was used for women in medication-assisted treatment for opioid dependence.~      The intervention group subjects were offered three mentalization-focused interactive 4D~     ultrasounds at 24, 30 and 34 gestational weeks and a mentalization-focused week-by-week~     pregnancy diary combined with three antenatal sessions and an option for one diary session~     after delivery. The control group received active treatment as usual in an obstetric tertiary~     setting.~      The pregnant woman and the child were followed-up until the child was one year old. The~     primary outcome was prenatal maternal depressive symptoms post-intervention, and secondary~     outcomes were anxiety symptoms, prenatal parental mentalization, maternal-fetal attachment~     and substance abuse. Other outcomes were utilisation of prenatal care, perinatal outcome,~     neonatal withdrawal symptoms and neonatal neurobehavior, postnatal maternal depressive and~     anxiety symptoms, parental mentalization, experienced stress from parenting and experienced~     social support, and emotional connection and commitment with the baby.~      The study was conducted at the hospital maternity outpatient clinic for substance-abusing~     pregnant women at Turku University Hospital (Finland) between October 2011 and December 2015.~     The registration of the trial is made retrospectively, but the research plan and outcomes are~     reported in this registration as they were originally documented in the research plan~     approved by The Joint Ethics Committee of the University of Turku and the Hospital District~     of Southwest Finland on 14th of June 2011.~   "
11704|NCT03413618|"~     The randomized clinical study aimed to assess the efficacy and safety of standard~     anticoagulation with rivaroxaban in combination with diosmin compared to the isolated use of~     standard rivaroxaban for prolonged therapy of acute femoro-popliteal deep vein thrombosis~     reflected the speed of deep vein recanalization and incidence of post-thrombotic syndrome.~   "
11705|NCT03413605|"~     Colorectal cancer (CRC) is the second most commonly diagnosed cancer and the third highest~     cause of mortality in Vietnamese and Asian Americans. CRC incidence is rising rapidly in~     Vietnamese Americans, but they have among the lowest rates of CRC screening (14%) and are~     more likely to be diagnosed with advanced stage disease, which is highly preventable. Over~     85% of Vietnamese Americans in our region (PA, NJ and NYC) are foreign-born with limited~     English proficiency, have low SES, and live in economically disadvantaged neighborhoods. Many~     lack knowledge about CRC risks and screening benefits and have limited access to culturally~     appropriate preventive care. Center for Asian Health, Temple University will be working with~     Vietnamese CBOs to address their critical health disparities. The investigators will test the~     hypothesis that the proposed multilevel CRC intervention will yield higher CRC screening~     rates compared to the control at 12-month follow-up. This project represents the first~     large-scale community-based randomized controlled trial of a multilevel,~     culturally-appropriate intervention to increase CRC screening among underserved Vietnamese.~     If effective, this innovative CRC intervention can be used as a model program that has~     potential impact, generalizability and sustainability in Asian American and other underserved~     ethnic communities.~   "
11706|NCT03413592|"~     The purpose of this study is to verify the intra-individual difference of the SDLP values in~     driving simulator.~   "
11707|NCT03413579|"~     The objective of the present study is to estimate the overall survival of patients with~     cervical cancer after the administration of monoclonal antibody (mAb) Nimotuzumab (hR3) in~     combination with chemotherapy of first intention. Patients will be randomized in two parallel~     treatment groups. The first group will receive a dose of 200 mg of monoclonal antibody~     anti-hR3 (weekly during 18 weeks), combined with a chemotherapy (6 cycles, every 21 days of~     Cisplatin 70mg/m2, Vinorelbine 60 mg/m2 (Per Os) at D1 and D8 and then 80mg / m2. The second~     group will receive a placebo in combination with the same chemotherapy regimen as the first~     group.~      At the end of the first intention chemotherapy treatment, a dose of maintenance of~     Nimotuzumab will be administered at the dose of 200mg every 14 days until progression. A~     second chemotherapy in the second intention is proposed, this one is based on Carboplatin (~     CBP) in an AUC (area under curve) of 6, and Paclitaxel (Txl) in 175 mg / m2 / BSA (body~     surface area ) in drip of 3 hours, every 3 weeks, concomitant with the administration of hR3,~     every 14 days, until a limit of toxicity or an ECOG (Eastern Cooperative Oncology Group)~     status superior to 3, appears.~   "
11708|NCT03413566|"~     Many studies have reported that the prevalence of cerebral palsy (CP) has been relatively~     stable and is mainly due to events before birth and therefore cannot be prevented. However,~     these studies were undertaken in populations born towards the end of the last century. There~     has since been significant improvement in both obstetrical and neonatal intensive care.~      The main aim is to investigate trends in the prevalence and clinical characteristics of~     children with CP in Norway born from 1996 to 2010 in order to gain a modern understanding of~     the panorama of CP in Norway. The investigators suspect that improved methods of obstetrical~     and neonatal care introduced in Norway during the last 20 years has resulted in a decrease in~     the prevalence of CP as well as in the proportion of children with severe CP subtypes and~     comorbidities. The long term aim is to improve the quality of pregnancy care and newborn~     medicine for children at risk of CP, and to ensure equal diagnostics and treatment of~     patients with CP, regardless of place of residence in Norway.~      For this project, the investigators will use data from three national health registers: The~     Cerebral Palsy Registry of Norway (CPRN), The Medical Birth Registry of Norway and The~     Norwegian Patient Registry (NPR). The use of data from these high quality health registries~     provides us with a unique opportunity to study our aims on a population level, as well as per~     health region/health trust.~   "
11709|NCT03413553|"~     The main hypothesis to be certified is that the addition of Subepithelial Connective Tissue~     Graft (SCTG) and Platelet rich Fibrin (PRF) to immediately placed implants will not~     significantly differ from immediately placed implant alone as regard gingival tissue~     stability.~   "
11715|NCT03413475|"~     The restorative and surgical odontological department at the Nantes University Hospital~     frequently hosts patients with a severely degraded oral condition who has never benefited~     from a removable prosthetic rehabilitation. The chosen treatment plan consists most of the~     time in extracting all the residual teeth at one or both arches with the immediate insertion~     of a complete removable prosthesis performed prior to the extractions. This prosthesis is~     adapted by regular relining during the osteomucosal healing and is replaced by a usage~     removable prosthesis on average 6 months after the extractions.~      The transition from dentate state (even dilapidated) to toothless state can be a source of~     discomfort and impairment and lead to a decrease of life's quality for patients. The purpose~     of this study is to evaluate oral health of the patients at the different stages of~     prosthetic rehabilitation by using GOHAI (Geriatric Oral Health Assessment Index).~   "
11716|NCT03413462|"~     To determine the efficacy of HS-25 (20mg) in reducing low density lipoprotein-cholesterol~     (LDL-C) levels after a 12-week period of treatment in adults with primary~     hypercholesterolemia;~      To determine the safety of HS-25 (20mg) in subjects with LDL-C~   "
11717|NCT03413449|"~     The purpose of this study is to develop an all-encompassing frailty model using laboratory~     and functional studies. A frailty model will help us determine prior to surgery who will~     require rehabilitation and skilled nursing needs beyond discharge. This model will also help~     us determine who will likely be readmitted and why they will be readmitted. Understanding~     these things can help us prevent some of them from occurring in the future.~   "
11718|NCT03413436|"~     The multicenter real-world and propensity score matching comparative study was designed to~     explore the toxicity and effectiveness of Lobaplation or Cisplatin based adjuvant~     chemotherapy in esophageal carcinoma~   "
11719|NCT03413423|"~     Summary of the Project :~      Quitting smoking following acute coronary syndrome (ACS) can reduce mortality up to 50%.~     However, depression and smoking are highly co-morbid and depressed mood may interfere with~     cessation and independently predicts mortality. Thus, a single, integrated treatment for both~     smoking and depression could be highly effective in reducing post-acute coronary syndrome~     mortality. Behavioral Activation (BA) is a well established treatment for depression and has~     recently shown promise as a treatment for smoking cessation. The investigators systematically~     developed an intervention integrating gold standard smoking cessation counseling with~     existing BA based mood management techniques for post-ACS smokers; Behavioral Activation~     Treatment for Cardiac Smokers (BAT-CS).~      Objective: For this R01 the investigators will evaluate the efficacy of using a single,~     integrated treatment that targets both depressed mood and smoking (BAT-CS).~   "
11720|NCT03413410|"~     This study is to test the feasibility and tolerability of the metoprolol optimal dosing~     pathway by observing the percentage of patients achieving target dose followed the pathway on~     ACS patients during hospitalization.~   "
11721|NCT03413397|"~     This phase II trial studies how well lenvatinib mesylate works with pembrolizumab in treating~     patients with gastric or gastroesophageal cancer that has spread to other places in the body~     or has come back. Lenvatinib mesylate may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth. Monoclonal antibodies, such as pembrolizumab, may~     interfere with the ability of tumor cells to grow and spread. Giving lenvatinib mesylate and~     pembrolizumab may work better at treating at gastric or gastroesophageal cancer.~   "
11722|NCT03413384|"~     This is a randomized, double blinded, placebo-controlled Phase II study to investigate the~     efficacy and safety of ceftriaxone in patients with mild to moderate Parkinson's disease~     dementia (PDD).This study will enroll approximately 106 patients to have up to 84 evaluable~     subjects, and conduct in Chung Shan Medical University Hospital, National Taiwan University~     Hospital,Taichung Veterans General Hospital and Kaohsiung Medical University Chung-Ho~     Memorial Hospital.~   "
11723|NCT03413371|"~     The aim of this randomized trial is to assess the efficacy of preventive analgesia using~     different peribulbar blocks (PBB) under SPI-guided anaesthesia for vitreoretinal surgery~     (VRS), presence of PONV (postoperative nausea and vomiting) and oculocardiac reflex (OCR) and~     compare Numerical Rating Scale (NRS) with Surgical Pleth Index (SPI) for monitoring pain~     perception postoperatively.~      Patients will receive general anaesthesia combined with either preventive PBB using either~     lidocaine with bupivacaine or bupivacaine or ropivacaine~   "
11724|NCT03413358|"~     The purpose of the study is to evaluate the efficacy and safety of Sheng Bai oral liquid in~     prevention and treatment of the decrease of neutrophilics after chemotherapy in patients with~     non-small-cell lung cancer.~   "
11725|NCT03413345|"~     It is a trial aimed to evaluate the ejection fraction in the preoperative phase and during~     follow-up in two groups of subjects undergoing major orthopedic surgery: the first consisting~     of subjects without history of cardiac disease, and the second from subjects with a history~     of cardiopulmonary disease~   "
11726|NCT03413332|"~     This two-phase research plan will develop and test a culturally relevant, web-based patient~     education program, hereafter known as E-Talkcare. The intervention aims to empower Chinese~     cancer patients to effectively communicate with different providers in different healthcare~     settings.~   "
11727|NCT03413319|"~     The purpose of this study is to assess the long-term safety and tolerability of ABBV-8E12 in~     subjects with progressive supranuclear palsy (PSP).~   "
11728|NCT03413306|"~     The analysis of our own clinical data suggests that majority of the hematologic responses~     observed after the course of h-ATG/CsA is partial, and about 10% tend to have cyclosporine~     dependence.~      The aim of the current study is to improve the rate and the quality of hematologic response~     as well as to prevent delayed complications such as relapse and clonal progression by means~     of adding eltrombopag to standard immunosuppressive therapy~   "
11729|NCT03413293|"~     Hospital acquired chest Infections are common complications in hospitalized cirrhotic~     patients. Infectious complications are the most common cause of mortality in cirrhotic~     patients with bronchopneumonia early antibiotic treatment at the base of culture and~     sensitivity is an optimal therapeutic approach in cirrhotics with nosocomial pneumonia~     Intensive care unit acquired pneumonia is the leading infection in critically ill patients~     and a major cause of morbidity and mortality despite recent major advances in antimicrobial~     therapy, supportive care, and the use of a broad range of preventive measures~   "
11730|NCT03413280|"~     The purpose of this study was to investigate the effectiveness of preemptive effect of rectus~     sheath block (RSB) and intercostal nerve block (ICNB) on postoperative visceral pain in~     laparoscopic cholecystectomy (LLC).~      After induction of general anesthesia, group of patient is decided randomly. In Group pre,~     RSB and ICNB are performed with 0.2% Ropivacaine 40ml before the operation. In Group post,~     RSB and ICNB are performed with 0.2% Ropivacaine 40ml after the operation.~      Measure the NRS and compare the rescue analgesic dose used at 0, 0.5, 1, 2, 6, 9, 18, and 24~     hours after arrival at the recovery room.~   "
11731|NCT03413267|"~     The nutritional quality of foods strongly depends on the structure / texture of foods,~     because of the impact on food disintegration, and then on digestion process and nutrient~     utilization by the human body. However, this relationship between food structure and nutrient~     bioavailability is still widely unknown.~      MicroNut project aims at demonstrating and evaluating in humans the impact of structure /~     texture changes on micronutrient bioavailability. In order to do this, four complex food~     matrices, with constant composition but different structures / textures, and as close as~     possible to real foods have been designed and are evaluated in the present study. A mixture~     of egg and plant proteins is the basis of these lipoprotein matrices in which four~     micronutrients will be followed up : two lipophilic (vitamin D and lutein) and 2 hydrophilic~     (vitamins B9 and B12).~   "
11732|NCT03413254|"~     The COLOPEC II multicentre randomized trial will investigate the role of second and third~     look laparoscopy to detect metachronous peritoneal metastases at a clinically occult stage~     during the follow-up of pT4 colon cancer patients. It is expected that detection of PM at a~     clinically occult stage will translate into survival benefit, due to higher percentage of~     patients eligible for curative intent treatment with cytoreductive surgery (CRS) and~     hyperthermic intraperitoneal chemotherapy (HIPEC).~   "
11733|NCT03413241|"~     The proposed project will be first performed on individuals with HF-ASD with their expected~     heterogeneity and healthy control (HC) subjects in order to explore the pain processing and~     modulation mechanisms underlying the pain sensitivity profile of adults with HF-ASD.~     Secondly, we will focus on individuals with ASD and HC, without ASR (ASD-nonASR, HC-nonASR)~     and with SHR (ASD-SHR, HC-SHR). This 2X2 factorial design will enable us to determine whether~     the feature of SHR in individuals with HF-ASD contributes to pain sensitivity. This research~     project will comprise of two sessions. Session I will include the following tests ADOS-2 for~     ASD diagnosing (only for individuals with ASD), intelligence quotation testing (IQ Wechsler~     Abbreviated Scale of Intelligence® - Second Edition (WASI®-II)107, serving for inclusion~     criteria. Session II will include familiarization with the researchers and lab, thermal~     detection threshold testing for small fiber abnormality identification since detection~     thresholds in some reports found to be abnormal pain threshold testing, and completion of~     questionnaires (see section 3.6 for details), psychophysical testing and EEG recordings in~     the following order: i) rEEG recordings; ii) psychophysical pain assessments; simultaneously~     with iii) neurophysiological pain assessments with pain EPs recorded. Our research protocol~     will be approved by the Helsinki Committee of the Rambam Health Care Center and The Chaim~     Sheba Medical Center.~   "
11734|NCT03413228|"~     Hospital-acquired influenza is associated with significant morbidity and mortality in~     hospitalized patients notably elderly patients. Furthermore, it is also associated with a~     large economic impact for the hospitals.~      The transmission of influenza has been mostly reported in pediatric and long-stay units. The~     chains of transmission of influenza in acute-stay units have to be describe in order to~     prevent and control potential outbreaks. Furthermore, to know clinical symptoms seems to be~     important in order to identify potential sources of virus as soon as possible and to set up~     appropriate hygiene prevention measures. Moreover, the definition of the hospital-acquired~     influenza has to be harmonized for all over the studies, especially concerning the delay~     between the admission in the hospital and the symptoms onset.~      The aim of this study is to describe the hospital-acquired influenza in a french university~     hospital of around 800 beds~   "
11735|NCT03413215|"~     This study aims to investigate whether channeling purposefully structured resources to~     patients at high risk of developing diabetic complications to interdisciplinary team clinic~     consultations, interspersed with closer remote follow-up and aided by simple technology will~     be more effective than usual care in controlling diabetes mellitus, controlling multiple~     cardiovascular risk factors and reducing clinical event rates.~   "
11736|NCT03413202|"~     This is a randomized, triple-blind, placebo-controlled, multicenter clinical trial.~     investigators plan to enroll 774 eligible patients, which will be randomized into either the~     butylphthalide (NBP) or placebo group in a 2:1 ratio.The main purpose of this study is to~     determine whether butylphthalide can improve dynamic Cerebral Autoregulation (dCA) in~     large-artery atherosclerosis acute ischemic stroke.~   "
11737|NCT03413189|"~     Survival following a critical illness continues to improve with ongoing developments in~     medical management, however evidence shows that this patient group is at a high risk of~     suffering long term disability. The objectives are to determine if there is a link between~     the amount of exercise performed in intensive care on the presence of delirium, long term~     cognition and disability whilst ensuring that patient reported outcomes correlate with actual~     measured results, and to obtain information on recovery from patients and/or relatives to~     determine themes.~   "
11738|NCT03413176|"~     Antiangiogenics (AAs) which are vascular endothelial growth factor (VEGF) or VEGF receptor~     (VEGFR) inhibitors might have high grade adverse events (AEs) on the cardio-vascular system.~     This study investigates reports of cardio-vascular toxicity with treatment including VEGF and~     VEGFR inhibitors using the World Health Organization (WHO) database VigiBase.~   "
11739|NCT03413163|"~     This study will define the postoperative analgesic effect of ESP block via amount of~     patient-controlled analgesia (PCA) and postoperative analgesic consumption (such as routinely~     and rescue analgesics) and compare the control group patients with retropubic radical~     prostatectomy .~   "
11780|NCT03412617|"~     Many provinces in Indonesia have some well known traditional foods that are widely consumed,~     but it remains unknown whether traditional ethnic dietary patterns can confirm healthy diets.~     High quality diet is associated with reduced risk of metabolic diseases and modulated gut~     microbiota. Moreover, the relationship between dietary quality and microbiota, a potential~     mediator of metabolic disease, has not been studied.~   "
11740|NCT03413150|"~     Aims Amiodarone is the gold-standard medication to control heart rate in critically ill~     patients with atrial tachyarrhythmias (ATs); however, effective doses and covariates~     influencing its efficacy remain unknown. The investigators therefore performed~     pharmacodynamic modeling of heart rate reduction induced by amiodarone in these patients.~     Methods and Results This observational study included 80 consecutive severely ill patients~     receiving amiodarone to treat ATs. A total of 1348 time-heart rate observations with 361~     amiodarone dose administrations were analyzed during a period of up to 6 days after hospital~     treatment initiation using a nonlinear mixed-effect model. Pretreatment with amiodarone~     before intensive care administration, paroxysmal versus persistent AT, catecholamine~     infusion, and fluid and magnesium loading were among the covariates assessed in the model. In~     case of paroxysmal AT in a patient not pretreated with amiodarone, a 300 mg intravenous~     loading dose combined with an 800 mg oral dose on the first day, followed by 800 mg/day~     orally for 4 days was effective in achieving a heart rate between 80 and 115 bpm within the~     first day, and to maintain it during the next 4 days. Corresponding doses were twice as high~     in patients with persistent AT. Use of intravenous magnesium (p\0.02) and fluid loading~     (p\0.02) was associated with an earlier and greater heart rate decrease, while use of~     dobutamine had an opposite influence (p\0.05). Conclusions In critically ill patients with~     AT, the dose of amiodarone required to control heart rate is influenced by the type of AT and~     by other easily measurable conditions which may allow better individualization of amiodarone~     dosing.~   "
11741|NCT03413137|"~     This will be a prospective cohort trial that compares transperineal to transrectal MRI-US~     fusion prostate biopsy~   "
11742|NCT03413124|"~     The purpose of this study is to compare the pharmacokinetics of MGL-3196 capsules with~     MGL-3196 tablets in healthy male subjects and female subjects not of child-bearing potential.~   "
11743|NCT03413111|"~     Selective cannulation is considered the most challenging step for most of Endoscopic~     retrograde cholangiopancreatography (ERCP). Wire-guided cannulation is the standard technique~     for initial cannulation. When meeting difficulty, double wire technique (DWT) is widely used.~     With one guidewire occupying pancreatic duct (PD), the following cannulation of common bile~     duct (CBD) with a sphincterotome preloaded with another guidewire often becomes feasible.~     However, because of the small opening of the papilla, sometimes it is technically challenging~     for the following cannulation of CBD with the sphincterotome and PD guidewire in the same~     working channel. We hypothesized that a tiny cut of the opening of papilla, without the~     injury of pancreatic sphincter, may facilitate the success of DWT and shorten the overall~     cannulation time.~   "
11744|NCT03413098|"~     This investigation is a prospective, non randomized, non blinded study. This investigation is~     designed to evaluate the performance, comfort and ease of use with the F&P trial nasal mask~     amongst Obstructive Sleep Apnea (OSA) patients.~   "
11745|NCT03413085|"~     The objective of this study is to investigate the efficacy and safety of soft lens in myopia~     control.~   "
11746|NCT03413072|"~     Atrial Fibrillation is considered as one of a common cardiac arrhythmia that presented with~     rapid and irregular rhythm and has an increased incidence.There are different types of atrial~     fibrillation one of these is paroxysmal atrial fibrillation that defined as lasts longer than~     30 seconds and lasting less than 7 days, while atrial fibrillation lasting more than 7 days~     to less than one year or requiring pharmacological or electrical cardioversion is called~     persistent atrial fibrillation, referring to the American Heart Association 2006~     guidelines.Patients with atrial fibrillation suffer from serious complications like stroke~     due to thromboembolism, heart failure and death. Risk of stroke is 5-folds in patients with~     atrial fibrillation in addition to presence or absence of another clinical risk factors.~   "
11747|NCT03413059|"~     The applicability of different thoracic epidural analgesia for patients with flail chest~   "
11748|NCT03413046|"~     The investigators aimed to study the effect of chemotherapy on regulatory T cells (Tregs) in~     children with precursor B (PreB) acute lymphoblastic leukemia (ALL) at 15 and 33 days of~     malignity directed therapy. The investigators will analyze peripheral and bone marrow blood~     samples of the participants, obtained at diagnosis, 15 and 33 days of treatment, about Treg /~     non Treg cells and interleukin (IL)-2, IL-6, IL-10, and transforming growth factor (TGF) beta~     levels. By this means, investigators will search response to chemotherapy. Also,~     investigators will analyze correlation between Treg population-Treg related cytokines with~     demographic, clinical and laboratory findings of the participants with ALL at these certain~     time points. Additionally, the investigators will compare Treg population and minimal~     residual disease at 15-33 days of malignity directed therapy. Also investigators will compare~     these Treg-Treg related cytokines obtained from the participants with ALL and a healthy~     children control group whom are voluntary donors for bone marrow transplantation.~   "
11749|NCT03413033|"~     This study aims to observe the physiological effects of two different Semi-occluded vocal~     tract (SOVT) exercises in the larynx and pharynx when they are executed by individuals with~     constant vocal effort and without vocal pathology.~   "
11750|NCT03413020|"~     With increasing antibiotic resistance and unsatisfactory results of empiric eradication~     regimens, tailored therapy may be the best choice to achieve high efficacy for rescue~     treatment. This study aimed to evaluate the eradication rates, safety, and compliance of~     antimicrobial susceptibility-based tailored therapy for rescue treatment in patients with~     Helicobacter pylori infection.~   "
11751|NCT03413007|"~     The Immune compleX Predictive Index (iXip) is a predictive tool for prostate cancer (PCa)~     diagnosis that integrates PSA, PSA-IgM, prostate volume and age of the patient. An algorithm~     processes these parameters providing the probability of prostate cancer. Several prospective~     studies confirmed its ability to predict prostate cancer presence at biopsy and therefore to~     reduce the rate of useless prostate biopsies. Moreover, preliminary results from a~     prospective study showed that iXip could predict cancer aggressiveness, too.~   "
11752|NCT03412994|"~     (1) Evaluate the efficacy of apatinib in combination with standard second-line chemotherapy~     for advanced colorectal cancer. Whether it can prolong Progression Free Survival (PFS),~     overall survival (OS) in patients with advanced colorectal cancer and reduce symptoms and~     improve quality of life compared with standard second-line chemotherapy; (2) Observe the~     safety of apatinib for the treatment of advanced colorectal cancer.~   "
11753|NCT03412981|"~     To date very little research has been conducted on pregnant mothers. Research shows that~     mothers with obesity and gestational diabetes have children who have a higher risk of later~     developing obesity and diabetes compared to children born to non-obese mothers but the~     mechanisms are not known. The maternal environment may place these babies at greater risk and~     it is possible that fat tissue (adipose tissue) releases many chemicals (adipokines and~     inflammatory cytokines) which may have an impact on the baby. Mothers who have greater~     amounts of adipose tissue most likely release these adipokines into the baby and it may~     affect the baby's body composition and/or health.~      This project will establish if there is a relationship between obesity and adipose tissue~     inflammation in pregnant mothers, and if there is a link between inflammation and the child's~     body composition.~      We will recruit mothers with low risk pregnancies already schedule for a C section at about~     36 wk. We will do initial testing at 36 wk, adipose tissue collection at delivery, and~     conduct post testing at 1 month postpartum on the mother and the baby.~   "
11754|NCT03412968|"~     This study aims to analyze the impact of using polysulfone membranes on continuous~     ultrafiltration with volume replacement in patients undergoing cardiac surgery. In this type~     of surgery, techniques such as conventional ultrafiltration (CUF) and modified~     ultrafiltration (MUF) are known for controlling the patient's fluid balance during the~     procedure. However, there is no scientific evidence on the benefits of continuous~     haemofiltration with volume replacement and its effect on lactatemia. Method and design: A~     single center randomized controlled trial, parallel treatment design with patient-blinded to~     compare outcomes in terms of the lactate clearance rates (quantity/unit of time) of the~     assigned therapy groups. Participants will be randomly assigned to receive the type of~     surgery, in order to ensure an unbiased assessment of treatments, randomisation will be~     performed in eight blocks of five patients. The study groups will be equivalent in all~     aspects except the procedures they undergo. Participants will be assigned to the first~     control group without haemofiltration (CG or 1) or one group with haemofiltration using a~     Polysulfone filter (PG or 2). Data will be collected by a blinded evaluator.~   "
11755|NCT03412955|"~     This is a pilot study, the principal investigator plans to enroll 14 patients. If 2 or more~     responses are documented, the principal investigator will consider to start a new phase II~     study. If there is less than 2 responses in the 14 patients, it is unlikely that Eribulin~     will produce 15% or more response rate in patients with active brain metastases, thus~     indicating no need to study further. Based on Poisson distribution, there is 38% probability~     of observing 1 or 0 response even if the underlying response is 15%. There is no null~     hypothesis, hence no p-value of significance.~   "
11756|NCT03412942|"~     A single-center, prospective, cohort analysis of the Femoral Introducer Sheath and Hemostasis~     (FISH) vascular closure device will study 100 consecutive patients on which the device will~     be used to close the femoral artery after angiogram and/or endovascular procedure. Study will~     be conducted in order to establish the level of comfort and confidence that this device~     provides for both patients and physician in terms of hemodynamic and usage outcomes.~   "
11757|NCT03412929|"~     The purpose of this study is to evaluate the effectiveness of a honey-impregnated wound~     dressing at removing necrotic tissue in subjects with chronic foot or ankle wounds.~   "
11758|NCT03412916|"~     The aims of this study are to adapt, pilot and examine the credibility, acceptability, and~     feasibility of an evidence-based mind-body program, the Relaxation Response Resiliency~     Program for Chronic Pain (p3RP), and the p3RP-Digital Monitoring Device (p3RP-DMD), which is~     the p3RP integrated with a commercial DMD, the FitBit.~   "
11759|NCT03412903|"~     This trial investigates the effects of a comprehensive pharmaceutical assessment in an acute~     care geriatric hospital on the number of hospital readmissions and patient's days spent at~     home.~   "
11760|NCT03412890|"~     The purpose of this study is to determine the long-term efficacy of Relugolix 40 mg once~     daily co-administered with low-dose estradiol and norethindrone acetate for up to 52 weeks,~     on heavy menstrual bleeding associated with uterine fibroids in patients who previously~     completed a 24-week treatment period in one of the parent studies (MVT-601-3001 or~     MVT-601-3002).~   "
11761|NCT03412877|"~     Background:~      In gene transfer therapy, cells are taken from a person s tumor to isolate mutations. White~     blood cells are then taken from the person's body, changed with a type of virus to attack the~     tumor cells, and returned to the person.~      Objective:~      To see if gene transfer therapy shrinks tumors.~      Eligibility:~      People with certain metastatic cancer for which standard treatments have not worked~      Design:~      Participants will complete screening and stages 1-3 under another protocol. Screening~     includes:~      Undergoing a biopsy or surgery at the NIH to obtain pieces of tumor in order to grow tumor~     cells~      Medical history~      Physical exam~      Scans~      Blood, urine, heart, and lung tests~      The study has 7 stages:~        1. Screening tests repeated over 1-2 weeks. Participants will have leukapheresis: Blood is~          removed by a needle in one arm. A machine removes white blood cells. The rest of the~          blood is returned by a needle in the other arm. An IV catheter will be placed in the~          chest.~        2. Care at home over 6-12 weeks.~        3. Stopping therapy for 4-6 weeks while their cells are changed in a lab.~        4. Hospital stay for 1 week to get chemotherapy by IV.~        5. Receiving changed cells by catheter. Then getting a drug over 1-5 days to help the cells~          live longer.~        6. Recover in the hospital for 1 2 weeks. Participants will get drugs and have blood and~          urine tests.~        7. Participants will take an antibiotic and maybe an antiviral for at least 6 months after~          treatment. They will have repeat screening tests at visits every few months for the~          first year, every 6 months for the second year, then as determined.~   "
11762|NCT03412864|"~     This study is post-marketing surveillance of Invossa K injection in patients with~     osteoarthritis.~   "
11763|NCT03412851|"~     Our aims is to evaluate the equality in efficacy and safety between direct aspiration~     technique and stent retriever thrombectomy procedure in anterior circulation strokes in a~     multicenter, prospective study.~   "
11764|NCT03412838|"~     A main drawback of bone block graft surgery is the resorption occurring in early stages of~     healing. The aim of this work was investigate different factors associated with graft~     resorption in allogeneic bone block graft surgery.~   "
19768|NCT03308227|"~     The study measures the plasma and bronchoalveolar lavage fluid concentrations of linezolid in~     septic shock patients comparing with non-septic shock patients to confirm the impact of~     septic shock on PK/PD of linezolid.~   "
11765|NCT03412825|"~     Arkansas has one of the highest rates for food insecurity and 27.7% of children in the~     University of Arkansas area are food insecure. In addition, more than 14% of children ages~     2-4 are obese and 20% of children ages 10-17 are obese. In Northwest Arkansas, the area~     surrounding the University of Arkansas in Fayetteville (Washington County), the food~     insecurity rate for adults is 17.9% (an estimated 34,730 individuals) and the food insecurity~     rate for children under 17 years of age is 24.4% (12,150 individuals). In addition, the~     surrounding counties have similar food insecurity rates (This makes Northwest Arkansas an~     ideal location to conduct a pilot study focusing on egg supplementation, childhood obesity,~     and food insecurity~     (http://www.feedingamerica.org/hunger-in-america/our-research/map-the-meal-gap).~   "
11766|NCT03412812|"~     This study looks at dose escalation for five fraction stereotactic radiotherapy for patients~     diagnosed with brain metastases with tumors 2.1-4.0 cm in diameter or 4.1-6.0 cm in diameter.~   "
11767|NCT03412799|"~     This is an open-label phase 1A/1B study to assess the safety, tolerability and~     pharmacokinetics of SBP-101 when combined with nab-paclitaxel and gemcitabine in subjects~     with previously untreated metastatic pancreatic ductal adenocarcinoma and to identify a~     recommended phase 2 dose. The study will also assess preliminary efficacy of the 3-drug~     treatment combination.~   "
11768|NCT03412786|"~     In this Phase I study, patients with hormone-sensitive Prostate Cancer (PC) and lymph node~     metastases are treated with the cancer vaccine Bcl-xl_42-CAF09b. The aim of the study is to~     clarify the safety and toxicity of the vaccine and also the immunological effect.~      The vaccine Bcl-xl_42-CAF09b is composed of the peptide Bcl-xl_42 and the adjuvant CAF09b.~     The B-cell lymphoma extra large protein (Bcl-xl) protein plays a vital role in the cancer~     cell's ability to avoid programmed cell death (apoptosis) and is upregulated in a variety of~     cancerous diseases. Bcl-xl_42 is a peptide fragment of the full protein and preclinical~     studies have shown that vaccination with this peptide (Bcl-xl) can activate the immune system~     and thereby lead to the death of cancer cells. In order to improve the activation of the~     immune system, adjuvant CAF09b is added; Preclinical studies have shown that special~     intraperitoneal (IP) injections of CAF09b improve the activation of the immune system.~   "
11769|NCT03412773|"~     This is a Phase 3, randomized, open-label, multicenter, global study designed to compare the~     efficacy and safety of BGB-A317 versus sorafenib as a first-line systemic treatment in~     patients with unresectable hepatocellular carcinoma. This study also includes a substudy~     investigating the safety, tolerability, PK, and preliminary efficacy in HCC in Japanese~     patients. In Japan, preliminary safety and tolerability will be evaluated (Safety Run-In~     Substudy) before Japanese patients are recruited in this Phase 3 study.~   "
11770|NCT03412760|"~     This is a multi-center, prospective study designed to investigate the genetic etiologies of~     non-immune hydrops fetalis (NIHF) and other birth defects. In the setting of NIHF, up to~     40-50% of prenatally diagnosed cases remain of unknown etiology after standard work up, and a~     substantial proportion of other birth defects remain of unknown etiology as well. The~     investigators will perform whole exome sequencing (WES) for the fetus or neonate, as well as~     both biological parents, in each of these cases to investigate the underlying genetic~     etiology.~   "
11771|NCT03412747|"~     This is a study to compare the efficacy of bimekizumab versus adalimumab in the treatment of~     subjects with moderate to severe chronic plaque psoriasis (PSO).~   "
11772|NCT03412734|"~     This is a randomized controlled trial to determine the influence of chlorhexidine gluconate~     surgical/topical antiseptic solutions on the bacterial environment of the vagina during~     hysterectomy and compare that to the effect of standard iodine-based preparations on the~     same.~   "
11773|NCT03412721|"~     The aim of this study is to determine the effectiveness of Er:YAG pulse therapy for achieving~     pulpal analgesia in pediatric patients and to quantify the duration and extent of any effects~     assessed.~      Design: a randomized split-mouth study with two-way repeated measures design.~   "
11774|NCT03412708|"~     Objective: To investigate the effect of vestibular rehabilitation exercises supported with~     virtual reality using virtual glasses technology on dizziness, static and dynamic balance,~     functional mobility, fear of falling, anxiety and depression in the short term (3 weeks) in~     the elderly with dizziness.~   "
11775|NCT03412695|"~     The prevalence of disease-related malnutrition among hospitalized patients is 30-50%. There~     is a lack of tools to follow up the nutritional treatment of these patients. The~     investigators develop the decision support system MyFood which can be used to assess~     patients' dietary intake, evaluate intake against individual needs, and propose nutrition~     related measures and an individual nutrition plan for each patient. The investigators will~     study the clinical effects of using MyFood among hospitalized patients. In addition the~     implementation of the tool among healthcare workers will be studied.~   "
11776|NCT03412682|"~     To demonstrate non-inferiority in efficacy of FE 999315 to mesalazine in patients with mild~     to moderate active ulcerative colitis after 8 weeks of treatment.~   "
11777|NCT03412669|"~     Background: Burden in addiction-affected families is a huge problem (well over 100 million~     family members worldwide are affected by substance use of a relative), largely unrecognised~     and untreated. Affected family members (AFMs) are vulnerable to physical and mental~     ill-health, reduced quality of relationships in the family, and family violence. In India,~     the burden of alcohol use is increasing: attitudes regarding alcohol use and alcohol~     availability, consumption patterns, age of drinking onset, levels of heavy drinking and~     alcohol-related problems, are all changing for the worse. These changes to levels of alcohol~     consumption and problems will have caused a corresponding increase in the prevalence of AFMs,~     although they are largely a hidden group. Yet, despite clear evidence of the burden of~     alcohol use on families, there is a lack of adequate support and targeted services for them.~     The objective of our study is to examine the preliminary effectiveness, feasibility and~     acceptability of Supporting Addiction Affected Families Effectively (SAFE) versus Enhanced~     Usual Care (EUC) in improving clinical outcomes.~      Methods: Our study is a parallel arm Pilot Randomised Controlled Trial of a psychosocial~     intervention for family members affected by a relative's alcohol use, in Goa, India. 100 AFMs~     will be recruited by referrals from community gatekeepers and professionals, and~     self-referrals resulting from media coverage of the study and and word-of-mouth publicity.~     Those who consent will be allocated in a 1:1 ratio to receive either SAFE (counselling) or~     EUC (information sheet). SAFE will be delivered by lay counsellors over 5 sessions spread~     across a month and a half, and EUC will consist of an information sheet on alcohol use, its~     nature, impact and treatment. The primary outcome is mean difference in 'symptoms' scores~     assessed by the Symptom Rating Test (at 3 months). Secondary outcomes are mean differences in~     'coping' scores assessed by the Coping Questionnaire, 'impact' scores assessed by the Family~     Member Impact Questionnaire, and 'support' scores assessed by the Alcohol, Drugs and the~     Family Social Support Scale (at 3 months). The primary analyses will be intention-to-treat at~     the 3-month end-point.~      Discussion: Our study will aid the process of translational research, by adopting frameworks~     that have an established evidence base, and implementing these frameworks in a culturally~     appropriate manner to newer underserved populations.~   "
11782|NCT03412591|"~     Insomnia is an extremely common and poorly treated problem in patients with substance use~     disorders (SUD)s undergoing rehabilitation treatment in a residential facility. The~     persistence of insomnia in substance use disorders (SUDs) may be associated with tonic levels~     of drug craving. Insomnia and craving can predispose to relapse in patients with SUDs.~     Insomnia and SUDs are independently associated with increased cortisol indicating~     physiological dysregulation of the stress response system including the~     hypothalamic-pituitary-adrenal (HPA) axis. Hence sleep disturbance, craving and increased~     cortisol leads to relapse in SUD subjects. Suvorexant, an orexin 1 / 2 receptor antagonist,~     approved by the FDA for the treatment of sleep disturbance in subjects with primary Insomnia.~     Previous animal studies report Orexin 1 receptor antagonist decreases craving and normal the~     HPA axis. However, the efficacy of suvorexant on sleep and craving in SUD subjects is not~     known. The primary aims of this study are-~        1. To determine if suvorexant will improve sleep quality (increased total sleep time, fewer~          awakenings), as measured through wrist actigraphy and the Insomnia Severity Index (ISI)~          in SUDs.~        2. To assess whether or not SUDs patients treated with suvorexant endorse scale items on a~          modified abuse liability assessment battery.~        3. To determine if daily reports of mood, stress, craving and sleep using Ecological~          Momentary Assessment (EMA data) change during the course of the study as patients with~          SUDs are treated with suvorexant.~        4. To determine if patients taking suvorexant will have a decrease in total daily salivary~          cortisol over the course of the study by collecting samples at five time points in a~          day, for two consecutive days at two different times in the study.~   "
11783|NCT03412578|"~     The effect of Tactile/Kinaesthetic massage therapy on weight gain and different components of~     growth, as assessed by anthropometric measurements and DXA scan, and correlate these~     components with serum IGF-1, leptin and adiponectin in preterm infants.~   "
11784|NCT03412565|"~     The purpose of this study is to evaluate the clinical benefit of subcutaneous (SC)~     daratumumab administered in combination with standard multiple myeloma (MM) regimens in~     participants with MM as measured by overall response rate (ORR) or very good partial response~     (VGPR) or better rate.~   "
11785|NCT03412552|"~     Laboratory monitoring of patients included serial measurement of complete blood cell count,~     liver function tests, coagulation profile, and renal function tests.~      ICU management during conduction of the research study included the following:~      Control of convulsions using magensium sulphate. Control of blood pressure Diastolic blood~     pressure above 110 mmHg, nifedipine was administered.A plasma volume expansion with saline~     was used in all women to maintain sufficient intravascular volume. Delivery was performed~     immediately after hemodynamic stabilization and clinical control of general condition .~   "
11786|NCT03412539|"~     The participants in the study are patients who undergo surgery to damaged nerve transmission~     and processing system in the nervous system as part of the routine clinical treatment that~     will not be affected by the proposed study. Patients who are candidates for procedures are~     referred from all over the country and undergo a multidisciplinary evaluation in the~     framework of the Palliative Pain Management Clinic, which operates exclusively in Israel at~     the Sourasky Medical Center in Tel Aviv.~   "
11787|NCT03412526|"~     Adoptive cell therapy (ACT) with tumor-infiltrating lymphocytes (TILs) in combination with~     lymphodepletion and high-dose interleukin 2.~      Most TIL ACT trials have been conducted as salvage therapy for patients who already had~     failed numerous treatments; many study participants presented with multiple metastases,~     frequently in visceral organs and even in the brain. The effectiveness of TIL ACT in~     eradicating metastatic tumors of the responding patients underlines the value of this~     immunotherapeutic approach.~      Recent developments in the identification and selection of tumor-specific T-cell populations~     have facilitated the implementation of TIL ACT also in nonmelanoma malignancies. Building on~     the experience of Ella Lemelbaum Institute, Sheba Medical Center with ACT TIL in the~     treatment of metastatic melanoma, the Dept. of Oncology, Tel HaShomer has expanded the use of~     TIL ACT following a reduced intensity, non-myeloablative, lymphodepleting induction regimen~     to metastatic Melanoma, Ovarian (OC) and Cervical cancer patients. The rationale supporting~     these studies is to further develop the ACT TIL procedure and expand its applicability to~     metastatic OC and cervical cancers.~   "
11788|NCT03412513|"~     The purpose of this study is to see the study drug, Mirabegron, is safe and effective in~     treating symptoms of Overactive Bladder in patients with Parkinson's disease.~   "
11789|NCT03412500|"~     An open-label randomized controlled trial to compare two vancomycin dosage adjustment methods~   "
11790|NCT03412487|"~     25 women with Premature Ovarian Failure who attended Fayoum university hospital gynecology~     outpatient clinic (case group) and another group of 25 women with normal ovarian function~     (control group).~      *Pelvic laparoscopy and ovarian biopsy will be done ovarian biopsy preparation~      For assessment of autoimmune oophoritis, sections were immunostained with anti-LCA (CD45)~     monoclonal antibody~   "
11791|NCT03412474|"~     Cleft palate (CP) is a common congenital malformation, with an incidence ranging from 0.1 to~     1.1 per 1000 births depending on the population group (liau et al, 2010). Early surgery is~     necessary to reduce phonation and feeding difficulties and reduce complications such as~     frequent sinusitis and other respiratory tract infections (Takemura et al., 2002).~      CP repair is painful, necessitating high doses of intravenous (I.V.) opioids. Therefore, the~     risk of postoperative respiratory depression and airway obstruction is important, and~     continuous monitoring is required during the initial 48h postoperatively (Roulleau et al,~     2003).~      Maxillary nerve block using the suprazygomatic approach is used in children since it presents~     a lower rate of complications (Captier et al, 2009). By this way, one can reach the nerve as~     it exits the skull at the foramen rotundum within the pterygopalatine fossa, before the~     location where its nervous branches innervate the palate (Prigge et al, 2014). This simple,~     reliable and almost risk-free approach can yield an effective and prolonged anesthesia with a~     clear decreased use of morphine agents during and after cleft lip-palate surgery in small~     children (Mesnil et al, 2010). The nerve block must be bilateral. The local anesthetic (LA)~     is directly injected in the middle part of the fossa at a distance from the foramen rotundum~     to avoid any trauma to the nerve or vascular injury, as soon as the tip of the needle has~     crossed the temporal muscle (Binet et al, 2015).~      Various adjuvants to local anesthetics to increase the duration of block are described in the~     literature and used in the daily clinical practice. Dexmedetomidine is a selective alpha 2~     (α2) adrenergic agonist with both analgesic and sedative properties. Animal studies showed~     that perineural dexmedetomidine added to bupivacaine or ropivacaine prolongs the duration of~     sensory and motor block (Brummett et al, 2011). Other clinical studies investigated the use~     of dexmedetomidine in patients undergoing ulnar nerve, axillary brachial and greater palatine~     nerve blocks, showed faster onset time and longer duration of block (Marhofer et al, 2013/~     Esmaoglu et al, 2010& Obayah et al, 2010).~   "
11792|NCT03412461|"~     Background: Seventy percent of lifetime cases of mental illness emerge prior to age 24. While~     early detection and intervention can address approximately 70% of child and youth cases of~     mental health concerns, the majority of youth with mental health concerns do not receive the~     services they need.~      Objective: This project will evaluate the impact of Thought Spot upon intentions and~     self-efficacy in help-seeking for mental health concerns among transition aged youth (youth~     aged 17-29) enrolled full-time or part-time at a college or university in the Greater Toronto~     Area (GTA), compared with a control group (who receive usual care; resource pamphlet).~      Methods: A two-group partially blinded pre-post randomized controlled study will be done to~     evaluate the impact of the digital platform, Thought Spot, on transition-aged youths'~     intentions to help-seek. Measurements will be taken over a 6 month period: baseline, 3~     months, and 6 months. 472 participants who are enrolled part-time or full-time at one of 3~     participating post-secondary institutions (George Brown College, Ryerson University,~     University of Toronto) who are interested in maintaining or managing their mental health will~     be recruited and randomized to the intervention arm or the control arm. The intervention~     group participants will have access to the Thought Spot platform. The control group~     participants will receive a pamphlet that outlines mental health services and wellness~     services across the GTA. Both groups will also have access to usual care.~      Results: The investigators are testing the hypothesis that 1) transition-aged youth who~     receive the intervention will show a greater improvement in intentions and self-efficacy in~     help-seeking for mental health concerns than those who are allocated to the control group;~     and 2) participants in the intervention arm will also show greater improvements in health~     literacy, including awareness of available services and supports, increased self-efficacy in~     managing their mental health concerns, and a reduction in mental health stigma, compared to~     the control arm.~   "
11793|NCT03412448|"~     The authors propose to evaluate the prevalence of chronic post-operative pain (CPOP) and~     continued opioid use in the population that has undergone cardiac surgery at the Montreal~     Heart Institute. In addition, the authors wish to evaluate the presence of known risk factors~     for CPOP in this population.~   "
11794|NCT03412435|"~     This study evaluates long-term outcome of patients diagnosed as acute myocardial infarction~     and treated with medication, coronary artery bypass surgery and percutaneous coronary~     intervention in Asan medical center, Korea.~   "
11795|NCT03412422|"~     Passive leg raise (PLR) and fluid challenge are useful tools in assessing the fluid~     responsiveness. However, they require continuous monitoring of cardiac output, which is~     usually an invasive technique and in some cases not always available. Vascular ultrasound can~     be an alternative to cardiac output monitoring in a fluid status evaluation. The common~     carotid artery (CCA) is an easily accessible vessel. It has recently been noted that the~     diameter of this artery changes after an intravenous fluid bolus. It is possible that the~     change in the diameter of the common carotid artery during passive leg raise and fluid~     challenge can be a predictor of fluid responsiveness.~   "
11796|NCT03412409|"~     This study aimed to evaluate the efficacy of reduced intensity conditioning (RIC) regimen in~     elderly or high comorbidity burden patients who receive haploidentical hematopoietic stem~     cell transplantation (haplo-HSCT). Haplo-HSCT is an effective treatment option for patients~     who did not have identical sibling donor (ISD) or unrelated donor (URD). However,~     post-transplant transplant-related mortality (TRM) is one of the major causes for transplant~     failure, and the risk of TRM for old patients or those with high comorbidity burden was~     higher. RIC regimen may decrease the risk of TRM for haplo-HSCT recipients. The study~     hypothesis: Using RIC haplo-HSCT regimen in elderly patients or those with high comorbidity~     burden can reduce TRM and improve survival.~   "
11797|NCT03412396|"~     The goal of this clinical research study is to learn if giving apalutamide before surgery~     affects the prostate cancer and makes it less likely that patients will have to receive~     radiation therapy after having surgery to remove the prostate.~      The safety of the drug will also be studied.~      This is an investigational study. Apalutamide is not FDA approved or commercially available.~     It is currently being used for research purposes only.~      The study doctor can explain how the study drug is designed to work.~      Up to 45 patients will be enrolled in this study. All will take part at MD Anderson.~   "
11798|NCT03412383|"~     A Phase II Study of Pyrotinib in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer~   "
11799|NCT03412370|"~     This pilot research trial studies how well questionnaires and cognitive assessments work in~     tracking patient symptoms following mammography. Gathering information over time through~     questionnaires and cognitive tests about symptoms patients may experience after a mammogram~     may help doctors understand the cause of these symptoms.~   "
11800|NCT03412357|"~     Malignant pleural mesothelioma is a cancer, caused by asbestos, which currently affects 2500~     people in the UK each year. The main symptom is breathlessness caused by fluid building up in~     the space between the lung and the chest wall (pleural effusion). Treatment involves draining~     the fluid to allow the lung to re-expand (pleurodesis). However, sometimes tumour growth over~     the surface of the lung can prevent it from re-expanding. This 'trapped' lung results in~     fluid re-accumulation and repeated drainage which can lead to discomfort and multiple~     hospital visits.~      One approach to dealing with 'trapped' lung in mesothelioma is to insert a thin tube~     (Indwelling Pleural Catheter - IPC) into the space around the lung. The tube can stay in~     place for a long time allowing patients to drain off fluid at home.~      Another approach is a keyhole surgical operation (video-assisted thoracoscopic partial~     pleurectomy/decortication - VAT-PD) to remove as much tumour as possible from the lining of~     the lung to allow it to re-expand.~      While both approaches are currently offered in clinical practice, it is not known which of~     the two is most effective at relieving breathlessness. The only way to find out is to conduct~     a research trial comparing the two. The Investigators plan to do this, but first of all need~     to carry out a small pilot study to collect information necessary to help plan the full~     study.~   "
11801|NCT03412344|"~     This research studies factors affecting Chinese patient participation in cancer clinical~     trials and their knowledge regarding clinical trials. The investigators design this study to~     determining how patients makes decisions about participating in a clinical trial and know~     about patients' attitude toward clinical trials. The investigators aim to find ways to make~     cancer clinical trials in China more efficient and satisfied patients participating in~     clinical trials in China.~   "
11824|NCT03412045|"~     Hyperbaric oxygen therapy in acute sickle cell pain crisis. The purpose of this study is to~     explore if hyperbaric oxygen therapy would decrease hospital length of stay and pain~     associated with acute sickle cell pain crisis. Eligibility criteria include both female and~     males age 19 years or older with sickle cell who are in an acute pain crisis. Exclusions~     include pregnancy and a sickle cell crisis complicated by any acute significant concomitant~     factors/conditions (i.e., acute chest syndrome, acute MI/stroke). Interventions would be 1-3~     hyperbaric oxygen sessions depending on response to the therapy. Each treatment session will~     be approximately two hours in length. Evaluation would be through patients' self assessment~     via the visual analog scale for pain level before and after treatments as well as tracking~     length of stay in the hospital.~   "
11802|NCT03412331|"~     Generalized aggressive periodontitis (GAgP) is a distinct type of periodontal disease~     characterized by rapid loss of attachment and alveolar bone occuring in young individuals.~     Photodynamic therapy (PDT) was introduced in periodontology as an adjunctive approach to~     non-surgical periodontal treatment (NPT) in periodontitis patients. In this trial, it was~     aimed that to evaluate the clinical and microbiological effects of adjunctive PDT to NPT in~     patients with GAgP. In this prospective controlled clinical study, 24 systemically healthy,~     non-smoking subjects with GAgP were enrolled. Subjects were randomly assigned to a control~     group (n=12) treated with NPT only or to a test group (n=12) treated with NPT and PDT. Plaque~     index, sulcus bleeding index (SBI), pocket depth (PD), relative attachment level, gingival~     recession, mobility were recorded at baseline and on day 63. Microbiological samples were~     obtained fom the sites with PD ≥5 mm at the same time points and evaluated for~     Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia,~     Tannerella forsythia and Treponema denticola using micro-IDent test.~   "
11803|NCT03412318|"~     A study to comparatively evaluate the post operative pain between root canal preparation by~     reciprocating file (TF) and full rotation file (M-Pro) in patients with single rooted teeth~     with acute irreversible pulpits.~   "
11804|NCT03412305|"~     The overall aim of the study is to investigate whether routine administration of antibiotic~     prophylaxis 1 hour prior to implant surgery may prevent postoperative infection and implant~     loss in healthy or substantially healthy patients (ASA Class 1 and Class 2).~   "
11805|NCT03412292|"~     This is a dose-escalation phase I trial to evaluate the safety and tolerability of MAX-40279~     in subjects with acute myelogenous leukemia(AML).~   "
11806|NCT03412279|"~     The Oswestry Disability Index (ODI), Roland-Morris Disability Questionnaire (RMDQ), SF-12~     Health Survey, Pain Catastrophizing Scale (PCS), and Back Beliefs Questionnaire (BBQ) are~     important and widely used validated patient self-reported measures commonly used in clinical~     trials and health research involving patients with chronic nonspecific low back pain.~     However, till date, validated Hausa versions of these tools are unavailable for use despite~     not only Hausa language is commonly spoken in Nigeria but in other parts of the world.~      The purpose of this study is to perform, using evidence-based guidelines, translation,~     cultural adaptation and validation of the ODI, RMDQ, SF-12 health survey, PCS, and BBQ into~     Hausa language among CLBP patients in Northern Nigeria.~   "
11807|NCT03412266|"~     This study aimed to evaluate the efficacy of reduced intensity conditioning (RIC) regimen in~     low- and intermediate-risk myelodysplastic syndrome (MDS) patients who receive haploidentical~     hematopoietic stem cell transplantation (haplo-HSCT). Haplo-HSCT is an effective treatment~     option for MDS patients who did not have identical sibling donor (ISD) or unrelated donor~     (URD). However, post-transplant transplant-related mortality (TRM) is one of the major causes~     for transplant failure in MDS patients, and the risk of TRM for haplo-HSCT recipients was~     higher than that of ISD recipients. RIC regimen can decrease the risk of TRM for haplo-HSCT~     recipients; however, the risk for relapse may increase in these patients. Thus, RIC regimen~     may be more appropriate for low- and intermediate-risk MDS patients receiving haplo-HSCT. The~     study hypothesis: Using RIC haplo-HSCT regimen in patients with low- and risk MDS can reduce~     TRM and improve survival.~   "
11808|NCT03412253|"~     Single- Anastomosis gastric bypass (SAGB) is a potentially curative line of treatment for~     type II diabetes mellitus (T2DM) patients with BMI 25-30 kg/m2. Accordingly, SAGB could be~     integrated into T2DM treatment algorithm~   "
11809|NCT03412240|"~     Cardiac pacing which involved stimulating the heart electrically with electrical wires that~     go into the heart is routine practice in the diagnosis and treatment of heart rhythm~     problems. Clinically this involved the fields of cardiac pacing and electrophysiology.~     Patients who are at risk of sudden death because of serious heart rhythms that are a result~     of malfunction of the electrical system of the pumping chambers of the heart (ventricles) are~     generally implanted with specialised pacemakers that can defibrillate (shock) the heart if a~     nasty life threatening rhythm should result. Shocks are painful and in order to try and treat~     these rhythms without shocks, anti tachycardia pacing is performed (this is routine part of~     the device), which aims to interrupt the rhythm by stimulating the heart electrically. This~     does not always work and can destabilise the rhythm leading to a shock. REVRAMP is a novel~     modification of anti tachycardia pacing which involved stimulating the heart through the~     defibrillator wires in a different way. It appears to work better and seems less likely to~     destabilise the heart rhythm, hence can reduce painful shocks.~   "
11810|NCT03412227|"~     The Overall Aim of the this project is to compare treatment outcomes and change in putative~     treatment mediators in Individual Behavioral Activation Therapy (IBAT) against two active~     psychological interventions (Coping Cat, PASCET) and a wait-list control. Participants will~     be 200 youth (ages 9-17) diagnosed with a principal anxiety or depression disorder and their~     caregivers.~   "
11811|NCT03412214|"~     The aim of this study is to evaluate the validity of perfusion index to determine the level~     of anesthesia in comparison with auditory evoked potential in children undergoing~     tonsillectomy.~   "
11812|NCT03412201|"~     STRONG-HF is a multicenter, randomized, parallel group study designed to evaluate the~     efficacy and safety of up-titration of standard oral heart failure medications during~     hospitalization for acute heart failure. Patients admitted for acute heart failure will be~     randomized 1-2 days before discharge to either usual care or intensification of treatment~     with a beta-blocker, a renin-angiotensin system blocker, and a mineralocorticoid receptor~     blocker (high intensity care arm). In the high intensity care arm, patients' clinical~     signs and symptoms of heart failure will be assessed, and routine laboratory measures and~     biomarkers will be measured, at frequent post-discharge visits. When these measures indicate~     that it is safe to do so, the doses of the oral heart failure medications will be increased~     to optimal levels. Patients will be followed through 90 days from randomization. Patients~     assigned to the usual care group will be followed by their general physician and/or~     cardiologist according to local medical standards. All patients, including those who were~     screened but did not meet eligibility criteria, will be followed for 90-day outcome.~   "
11837|NCT03411876|"~     Aim of this study is to investigate the effects of an Oxymizer pendant nasal cannula in~     hypoxemic patients with idiopathic pulmonary fibrosis during walking.~   "
43974|NCT02991222|"~     The objective of the study is to determine the relative bioavailability, safety and~     tolerability of SPARC001 and Reference001 in healthy, adult, male and female subjects~   "
11813|NCT03412188|"~     Using eltronmobag as an alternative pathway, which depend on stimulation of thrombocyte~     synthesis, in chronic and persistent immune thrombocytopenia may be more promising treatment~     than the classic type, not only by increasing platelets count but also through enhancing of~     the platelets activation and upregulation of GPVI expression on platelet surface.~      This study will include 40 pediatric patients with chronic or persistent ITP, recruited from~     the Hematology clinic of pediatric hospital Ain Shams University, aiming to investigate the~     efficacy, & the safety and tolerability of eltrombopag therapy for children as well as the~     ability of eltrombopag to enhance the platelet activation through the up-regulation of~     glycoprotein VI (GPVI) receptor expression in comparison with other lines of treatment.~      Patients will be divided into 2 groups : Group 1 on eltrombopag ; Group 2 : receiving other~     lines of therapy .~      All Patients will be subjected to :~        1. bleeding score assessment ( baseline &every month ) and Health related quality of life~          based on Kids' ITP Tools (KIT) questionnaires( baseline and week 24 )~        2. Baseline and at week 24 bone marrow examination with reticulin stain~        3. clinical examination every 2 weeks and complete blood counts.~        4. Assessment of soluble form of glycoprotein VI using sandwich enzyme-linked immunosorbent~          assay (ELISA) as well as assessment of platelet activation by GPVI using flowcytometry~          (Gardiner, etal.,2010 ) at baseline and at the end of 6 months treatment period~   "
11814|NCT03412175|"~     The CREATION Health Lifestyle Intervention (CHLI) will study the effect of a lifestyle~     intervention program on the cardiovascular risk profile (blood pressure, BMI, and Hemoglobin~     A1C) of participants diagnosed with hypertension and/or type 2 diabetes.~   "
11815|NCT03412162|"~     This study will implement an intervention designed to promote ethnic and racial identity~     development. It is hypothesized that the intervention will have positive effects on~     ethnic-racial identity development, stress biology (including sleep hours and quality and~     diurnal cortisol profiles), emotional well-being, executive functioning, and academic~     outcomes, particularly for minority youth.~   "
11816|NCT03412149|"~     Bariatric surgery represents the best therapeutic option to induce sustainable weight loss~     and to solve serious comorbidities improving the life-expectancy and the quality of life.~     Actually the choice of the procedure is based on the surgeon's and patients preference . Mini~     gastric bypass(MGB) is an emerging procedure offering excellent results in terms of weight~     loss and comorbidities (mainly metabolic) control. On the other hand, recent data indicated~     that the gut microbiota may mediate some of the beneficial effects of bariatric surgery and~     changes in the composition and diversity of the gut microbiota have been observed after RY~     Gastric Bypass (RYGB) in humans as well as in mice. However, there are no prospective~     investigations on Gut Microbiota changes after MGB, despite the procedure is described as~     malabsorptive and there are no studies comparing gut microbiota shift and malabsorption~     entity in humans after RYGB vs MGB. Thereafter prospective data on the incidence of bile~     reflux esophageal lesions after MGB are lacking.~      The aim of the present multicentric prospective comparative study is to evaluate~     malabsorption and gut microbiota shift after laparoscopic RYGB vs MGB at 1 year.~   "
11817|NCT03412136|"~     The purpose of this study was to determine the effect of acute protein and glucose intake on~     testosterone levels measured in adolescent boys and determine whether changes in testosterone~     levels are associated with alterations in short-term food intake. It was hypothesized that 1)~     ingestion of a protein beverage would result in no change of testosterone levels whereas~     glucose would result in a significant decrease of testosterone levels 60 minutes after~     ingestion and 2) decreases of testosterone levels as a result of the glucose preload would~     predict food intake for boys of similar body size. The first objective was to investigate the~     effect of an acute protein or glucose drink on testosterone levels and the second objective~     was to determine whether changes of testosterone levels associate with food intake.~   "
11818|NCT03412123|"~     This feasibility pilot is part of the project LiFE-is-LiFE (2017-2020). It is based on the~     Lifestyle-Integrated Functional Exercise (LiFE) program by Clemson et al., which has proven~     effective in improving strength, balance, and physical activity while simultaneously reducing~     falls in older people via incorporating exercises in recurring daily tasks. However,~     implementing the original LiFE program includes high financial requirements and human~     resources. Therefore, LiFE-is-LiFE investigates whether implementing LiFE in groups (gLiFE)~     is not inferior to the original, individually delivered LiFE in terms of reducing falls per~     physical activity. In this pilot study, we evaluate our conception of gLiFE for large-scale~     use in the subsequent, larger LiFE-is-LiFE trial.~   "
11819|NCT03412110|"~     Healthcare systems acknowledge the importance of patient safety including the reduction of~     preventable adverse events (AE). For healthcare providers who perform spinal manipulation~     therapy (SMT), the investigation of AEs remains in its infancy for several reasons including~     finding a reporting system that accurately collects AEs information, varied descriptions of~     AE's severity and occurrence frequency and the variable natural history of musculoskeletal~     conditions treated by SMT. Together, these factors act together to conspire against the~     implementation of systematic changes in SMT application that would result in improved patient~     care and safety.~      In addition, it is vital that patient safety training initiates at the start of a healthcare~     worker's career. This pilot active surveillance study was designed to assess the feasibility~     of collecting data with an electronic platform for patients' self-report of symptom changes~     as well as interns' report at a chiropractic teaching clinic.~   "
11820|NCT03412097|"~     Healthcare systems acknowledge the importance of patient safety including the reduction of~     preventable adverse events (AE). For healthcare providers who perform spinal manipulation~     therapy (SMT), the investigation of AEs remains in its infancy for several reasons including~     finding a reporting system that accurately collects AEs information, varied descriptions of~     AE's severity and occurrence frequency and the variable natural history of musculoskeletal~     conditions treated by SMT. Together, these factors act together to conspire against the~     implementation of systematic changes in SMT application that would result in improved patient~     care and safety.~      In addition, it is vital that patient safety training initiates at the start of a healthcare~     worker's career. This pilot active surveillance study was designed to assess the feasibility~     of collecting data on patients' self-report of symptom changes as well as interns' report at~     a chiropractic teaching clinic.~   "
11821|NCT03412084|"~     The purpose of the expanded study is to examine the effectiveness of a Stand Up and Move~     More intervention to reduce sedentary behavior in older adults from underserved communities.~   "
11825|NCT03412032|"~     Several approaches for summative assessment during Advanced Life Support courses are used.~     The most commonly used method during European Resuscitation (ERC) Council Life Support~     Courses is that 1 instructor is miming a whole team, and the candidate has to lead this~     team through a scenario; another variant of the summative assessment (mainly used by~     American Heart Association (AHA) Courses) is with a group of students, where one student is~     the team leader to be assessed and the others are his team not being assessed. The second~     approach might be more realistic; however there is no evidence around with regard to~     effectiveness (pass/fail rate, ability to test non-technical skills (NTS)) or~     participant/assessor satisfaction.~   "
11826|NCT03412019|"~     Several studies have demonstrated that music can improve various outcomes during labor and~     delivery. However, many of these studies didn't measure satisfaction rate accurately. This~     study aim to assess patient satisfaction in the setting of music or no music during the~     cesarean delivery. The study will be conducted in the labor and delivery unit and the~     expected number to enroll and complete the study is 22.~   "
11827|NCT03412006|"~     The purpose of the trial is the analysis of safety and efficacy of the chymase inhibitor~     BAY1142524 at a dose of 25 mg BID in comparison to placebo using a 6 months treatment period~     in type II diabetic patients with a clinical diagnosis of diabetic kidney disease. BAY1142524~     or placebo will be given on top of evidence-based standard of care for diabetic kidney~     disease. Primary objective is the analysis of first signs of efficacy as determined by~     favourable changes in urinary albumin creatinine ratio. Secondary objective is the analysis~     of safety and tolerability as evidenced by the incidence and severity of adverse events. 64~     valid patients have to complete treatment with verum and 32 valid patients have to complete~     treatment with placebo.~   "
11828|NCT03411993|"~     There is currently no routine screening for cardiac disease for pregnant women in areas of~     high prevalence. This study will aim to determine the point prevalence of cardiac disease in~     women presenting for antenatal care at Moi Teaching and Referral Hospital. More specifically,~     it will aim to use focused echocardiography as a screening tool to determine the prevalence~     of cardiac disease among pregnant women attending MTRH antenatal clinic.~   "
11829|NCT03411980|"~     The purpose of the study is to evaluate the pharmacokinetics of vilaprisan in subjects with~     moderate to severe renal impairment compared with matched subjects with normal renal function~   "
11830|NCT03411967|"~     In order to explore a new treatment strategy for patients with failed NSCLC~     platinum-containing double-drug therapy, this study was to investigate the clinical efficacy~     of apatinib in combination with docetaxel for patients with advanced NSCLC after failure of~     platinum-based regime~   "
11831|NCT03411954|"~     This is a prospective, non-randomized phase III study observing the cognitive function~     changes with conformal hippocampus avoidance during intensity modulated radiotherapy for T4~     nasopharyngeal carcinoma patients.~   "
11832|NCT03411941|"~     There is a need to investigate the effectiveness of IVT aflibercept injection in routine~     clinical practice.~      The aim of this study is to collect 12-month real-world clinical data from treatment-naïve~     nAMD patients who started first-line treatment with IVT aflibercept injection, according to~     the SmPC (Summary of Product Characteristics) and the SERV (Spanish Society of Retina and~     Vitreous) guidelines. The effectiveness of IVT aflibercept will be assessed by the changes in~     VA (Visual Acuity) and CRT (Central Retinal Thickness) during treatment.~   "
11833|NCT03411928|"~     The purpose of the study is to prospectively assess the use of a modified tracheal balloon~     dilator in children (<13 years old) with subglottic or tracheal stenosis. The hypothesis is~     that the device will effectively dilate the stenotic segment, whilst maintaining oxygenation~     (if applicable). The primary aim is to measure the stenosis prior to, and after dilatation;~     using diameter and the modified Myer-Cotton grading system. Secondary aims include assessment~     of stenosis at six-week follow-up and monitoring arterial oxygenation nadir (using peripheral~     plethysmography) during the procedure.~   "
11834|NCT03411915|"~     This is a Phase 1, multiple dose, ascending dose escalation study; to define a MTD/RD and~     regimen consisting of a first priming dose and escalated subsequent doses of XmAb18087; to~     describe safety and tolerability; to assess PK and immunogenicity; and to preliminarily~     assess anti-tumor activity of XmAb18087 in subjects with advanced NET or GIST.~      The study will enroll dosing cohorts to establish a MTD/RD and regimen in subjects with~     advanced NET or GIST, then enroll additional subjects into separate NET and GIST expansion~     cohorts to collect additional data on safety and potential efficacy of XmAb18087.~   "
11835|NCT03411902|"~     This is a pilot project to determine the feasibility of recruiting, enrolling, treating, and~     following 24 older sleeve gastrectomy patients into a randomized controlled trial (RCT)~     examining the efficacy of bisphosphonate use versus placebo in the prevention of surgical~     weight loss associated loss of bone mass and quality.~   "
11836|NCT03411889|"~     Watering eyes (epiphora) is a very common ophthalmic condition. It is frequently caused by~     dysfunction of the lacrimal (tear) drainage system which is the 'pipework' that takes tears~     from the eye to the nasal cavity. If the system is completely blocked then the patient is~     offered surgery to unblock or bypass the obstruction. However, the system is often either~     partially obstructed, or there is tear drainage delay despite there being no apparent~     obstruction (functional obstruction). Currently this is investigated with two separate scans,~     conducted at different times in different departments (CT and nuclear medicine). These are~     dacryocystography (DCG) and dacryoscintigraphy (DSG) and both are required as they have~     different limitations and benefits. Moreover DCG is a CT scan that uses radiation.~      Functional magnetic resonance dacryocystography (MR DCG) is increasingly widely used in other~     fields of medicine (e.g. cardiology) because of the increasing acquisition speed and~     resolution of MRI scanners in recent years. The investigators anticipate functional MRI of~     the lacrimal drainage system (i.e. scanning as eye drops are instilled and pass down the~     system) will overcome the shortcomings of DCG and DSG, by simultaneously providing both good~     anatomical detail and physiological images. Various methods of MR DCG have been described in~     the literature and there is no standard protocol for this procedure as of current. In this~     study, the investigators aim to develop a protocol for MR DCG that can be used in routine~     radiological practice in place of DCG and DSG and get pilot data on tear drainage in~     participants with known delayed tear drainage and controls with normal tear drainage systems.~   "
11838|NCT03411863|"~     Veterans are at higher risk than non-Veterans of falling ill with amyotrophic lateral~     sclerosis (ALS). ALS causes degeneration of motor neurons in both the brain and the spinal~     cord. Evidence from studies in people with spinal cord injury suggests that activating spared~     nerve circuits with electromagnetic stimulation improves nerve transmission.~      With this goal, the investigators have developed a novel method of noninvasive cervical~     (neck) electrical stimulation (CES). In this study, the investigators will investigate CES~     for its potential to strengthen nerve circuits to the hands in ALS.~      To the investigators' knowledge, electrical spinal stimulation for ALS has never been tested~     previously. This study will be performed in two stages: First, basic experiments will be~     performed to better understand how CES interacts with other types of electrical and magnetic~     stimulations over the brain and peripheral nerves. Second, experiments will be performed to~     determine the types of CES that can facilitate active arm and hand movements.~      These experiments will improve understanding of electrical stimulation in ALS, and may set~     the table for future treatments.~      Both United States Veterans and non-Veterans are eligible to participate in this study.~   "
11839|NCT03411850|"~     Ultrasound study focused on salivary gland outcomes in Sjogren's subjects~   "
11840|NCT03411837|"~     The investigators will monitor for the incidence of adverse-events in a prospective,~     longitudinal, non-interventional and observational real-world sub-study of adults patients~     with moderate-to-severe AD who are receiving dupilumab as standard-of-care therapy.~   "
11841|NCT03411824|"~     Community-acquired pneumonia (CAP) is frequently suspected in the Emergency Department (ED).~     However, usual diagnosis procedure based on clinical features and chest X-Ray has rather bad~     performances.~      A recent study on CT performance in suspected CAP found that 58% of classifications were~     modified by CT when compared with usual procedure. However, extended CT usage in CAP~     diagnosis is associated with many limitations :~      availability in a majority of ED, delay, cost and irradiation, in particular In young~     patients.~      Lung Ultrasound (LUS) has good performances in CAP diagnosis even when compared with CT. It~     is a rapid, inexpensive, radiation-free tool available in a majority of ED. It is performed~     at the patient's bedside with immediate results. The learning curve allows Emergency~     Physicians (EP) to perform this exam after a relative brief training.~      The Investigators aim to investigate LUS performances in clinically suspected CAP~     authentication , and assesses specific diagnostic contributions and impact on antibiotic~     prescriptions .~   "
11842|NCT03411811|"~     Participants with wrist pain on the little finger side of the wrist will received either~     usual care, consisting of ultrasound, specialized massage and stabilization exercises therapy~     for 6 weeks, or will receive injection of dextrose at 0, 3 and 6 weeks. After 9-week data is~     gathered, dextrose injections will be offered as needed to both groups, with follow-up at 6~     and 12 months~   "
11843|NCT03411798|"~     The drug regimes in treating ankylosing spondylitis(AS) have limitations. The tumor necrosis~     factor inhibitors(TNFi) was effective but expensive. Disease modifying anti-rheumatic drugs~     (DMARDs) were cheap but insufficient. This study proposed a sequential usage of TNFi, the~     Yisaipu®, and DMARDs, and aims to evaluate the mid-term therapeutic effect of this new scheme~     in treating the mild-to-moderate AS.~   "
11844|NCT03411785|"~     The Comprehensive Primary Care Plus (CPC+) Model, sponsored by the Centers for Medicare &~     Medicaid Services (CMS), is a multipayer advanced primary care model. CPC+ aims to strengthen~     primary care by transforming how primary care practices deliver care, supported by regionally~     based multipayer payment reform, learning support, data feedback, and health information~     technology (health IT) support. The CPC+ evaluation will assess how CPC+ was implemented; how~     practices transformed care; and the effects on cost, service use, quality of care, and the~     experiences of patients, primary care practitioners, and staff. The evaluation will also~     identify facilitators and barriers to implementation and improved outcomes.~   "
11845|NCT03411772|"~     Patients undergoing bariatric surgery will be divided randomly into two groups: the first~     will have TAP block upon completion of surgery and the second groups will not have TAP block.~   "
11846|NCT03411759|"~     The use of titrated drugs is at the base of a successful antalgic treatment in order to~     provide both an adequate relief and a satisfactory tolerability profile. These molecules,~     though, have a varying degree of efficacy in different subjects due to medical and genetic~     reasons. The latter are mainly represented by cytochrome (CYP) P450, in particular CYP2D6's~     polymorphisms are responsible for the diversified metabolism of analgesics used in chronic~     pain treatments.~      Four main types of enzymatic metabolism make up the population, each one defined by a~     different CYP2D6 allele: extensive metabolizers, ultra-rapid metabolizers, intermediate~     metabolizers and poor metabolizers.~      Moreover, regarding polytherapies, the analgesics' metabolism could be influenced by~     coadministration of other drugs, thus determining an inhibition or induction of the metabolic~     enzymes - known as phenocopying - and potentially also a change in the metabolic phenotype~     itself. The final outcome is the inconstancy of effectiveness and of the risk of developing~     side effects.~      The primary objective of this study is to define a genetic pattern for the gene CYP2D6 by~     assessing the incidence of poor or ultrarapid metabolizers in a population of chronic pain~     patients. This will also allow to observe phenocopying in the same population.~      Hence 100 patients diagnosed with chronic pain will be enrolled. The genetic pattern of the~     gene CYP2D6 of such patients will be examined by taking mouth samples. At the same time~     parametric tests for paired data to survey the correlations between phenotypical patterns and~     pharmacological therapies will be conducted.~   "
11855|NCT03411642|"~     The Comparative Effectiveness Study of Transthoracic and Transesophageal Echocardiography in~     Stroke (CONTEST) aims at assessing the diagnostic value of transesophageal echocardiography~     (TEE) and transthoracic echocardiography (TTE) with regards to treatment consequences in~     patients with acute ischemic stroke.~   "
11876|NCT03411356|"~     The primary aim of this study is to is to determine if intermittent fasting (IMF) is an~     effective dietary strategy for treatment of obesity. A 1 year randomized trial will be used~     to compare weight loss generated by IMF versus Daily Caloric Restriction (DCR). The targeted~     weekly energy deficit is designed to be similar (~30%) and a comprehensive behavioral support~     program will be provided to both groups. The primary outcome is weight change at the end of~     the 1 year intervention; follow up measures will also be obtained 6 months after completing~     the intervention. This study will provide robust data regarding weight loss effectiveness of~     IMF and will further our understanding of the impact of IMF on energy balance.~   "
11847|NCT03411746|"~     Subarachnoid hemorrhage (SAH) consists of blood extravasation into the space between~     arachnoid and pia mater. Bleeding is a consequence of cerebral aneurysm rupture in most~     cases. Despite incidence being only 9 cases out of 1000 people per year, young age and high~     mortality and morbidity lead to loosing several years of healthy life. Therapy priorities~     are: preventing rebleeding, with endovascular treatment (when possible) or neurosurgical~     aneurism clipping; preventing complications associated with blood extravasation into~     subarachnoid pace, such as acute hydrocephalus treatment (that occurs in 20% of patients), by~     ventricular external drainage positioning, and delayed cerebral ischemia, mainly due to~     vasospasm, by endovenous administration of nimodipine; optimal perfusion pressure~     maintenance.~      Endogenous osteopontin (OPN) is thought to fulfill a protective activity over ischemic damage~     both in brain and other organs, including kidney. Besides, recombinant OPN administration~     markedly decreases ischemic area in a focal cerebral ischemia model, by an antiapoptotic~     action. Recent in vivo studies on animal models of SAH demonstrated that OPN plays a major~     role: treatment with OPN seems to prevent vasospasm reducing smooth muscle cells and~     endothelial cells apoptosis.~      Microparticles are mediators released by platelets, leucocytes, erythrocyte and endothelial~     cells. In ischemic stroke endothelial microparticles levels directly relate to clinical~     severity and ischemic area extension. In typical parenchymal haemorrhage microparticles~     levels are higher both in blood and in liquor and associated with worse clinical outcome. In~     SAH increased microparticle levels have been demonstrated, especially in the days of the~     bleeding, and microparticle levels change based on subtypes. Data disagree about the subtypes~     involved and their time course. This study aims to evaluate the correlation between OPN and~     microparticles levels and vasospasm development/ischemic lesion at the CT-scan, and~     subsequently with medium and long-term patients outcome.~   "
11848|NCT03411733|"~     The objective of the study is to investigate prevalence of H.Pylori infection among acne~     vulgaris patients.~   "
11849|NCT03411720|"~     Persons with spinal cord injury (SCI) are confronted with a multitude of psychological and~     physiological changes post-injury leading to seemingly insurmountable barriers to~     participating in daily life. After injury persons with SCI engage in fewer social~     interactions, spend more time sedentary, and are less likely to leave the home. This leads to~     restricted social participation that, in turn, contributes to greater psychological problems~     and negatively impacts the lives of adults with SCI. Intense, structured exercise has~     substantial potential benefits for improving psychosocial wellbeing among persons with SCI,~     but accessible exercise options are few and cannot achieve high intensities of whole-body~     exercise. This work will use approaches to overcome the barriers to intense exercise. The~     investigators will use hybrid functional electrical stimulation row training (FESRT) to allow~     for a more intense exercise stimulus, potentially having a greater impact on psychosocial~     wellbeing. There is initial evidence that persons with mobility impairments who are highly~     physically active demonstrate better psychosocial wellbeing compared with those who have low~     levels of physical activity. A limitation to understanding the influence of exercise on~     psychosocial wellbeing is the lack of robust and time-dependent measures. The investigators~     will use a smartphone-based research application to measure psychosocial well-being, thus~     decreasing self-report bias and capturing in-the-moment behavioral and self-report data.~   "
11850|NCT03411707|"~     The primary objective is to determine the sensitivity and specificity of two Colorectal~     Cancer (CRC) screening methods, including stool DNA test and blood mRNA test, for colorectal~     cancer in Chinese population, with colonoscopy as reference method. Lesions will be confirmed~     as malignant or precancerous by colonoscopy and histopathologic examination.~      The secondary objective is to compare the performance of these two CRC screening methods to a~     commercially available FIT assay, both with respect to cancer and advanced adenoma. Lesions~     will be confirmed as malignant or precancerous by colonoscopy and histopathologic~     examination.~   "
11851|NCT03411694|"~     Previous studies showed that the role of the anesthesiologist, their education and role~     within the hospital is not known by the general public. The lack of knowledge about~     anesthesia can be an important factor in patients' fear before the planned surgery and can~     therefore impact patient's general satisfaction. By means of a survey in patients planned for~     elective surgery, the investigators want to investigate the perception of patients regarding~     the anesthesiologist, their education and role within the hospital, the general knowledge of~     the patient regarding anesthesia and possible pre-operative fears and concerns.~   "
11852|NCT03411681|"~     Obesity has numerous comorbidities that are associated with exceedingly high healthcare~     costs. In addition to well- characterized impairments in lipid and glucose metabolism,~     obesity is associated with altered protein metabolism. We have recently observed that obese~     individuals are essentially nonresponsive to protein ingestion with respect to myofibrillar~     protein synthesis. This suggests that skeletal muscle remodeling in obese individuals is~     impaired possibly contributing to a poor metabolic quality of muscle. Resistance exercise is~     known to strongly augment muscle protein synthesis in response to protein ingestion. The~     purpose of this research is to determine the muscle protein synthetic response during~     post-exercise recovery in obese individuals. Using stable isotope methodology, we will~     determine the postprandial muscle protein synthetic response in 14 male and female obese~     adults (Age: 20-45, BMI: 30-39.9 kg/m2) immediately after an acute bout of resistance~     exercise. Participants will be sedentary (< 60 min exercise/ week) and weight stable for a~     minimum of 6 months. During the testing blood and muscle samples will be collected. In~     addition participants will be asked to perform moderate intensity resistance exercise.~     Completion of the proposed research will identify the role of resistance exercise in the~     maintenance of skeletal muscle tissue after the consumption of a protein-dense meal in obese~     people.~   "
11853|NCT03411668|"~     Evidence-based practice (EBP) prevents unsafety/inefficiency and improves healthcare quality.~     However, EBP implementation and sustainment are challenging for healthcare organizations and~     providers considering gaps between research and practice. An educational preparation of the~     future healthcare professionals can minimize these gaps. Thus, it is mandatory that~     undergraduate curricula in health sciences, namely in nursing, promote an EBP culture so that~     future health professionals use it into clinical practice. Within the Portuguese context,~     there is no available scientific literature about the current state of EBP integration in the~     undergraduate nursing curricula. Thereby, the investigators intend to verify if an EBP~     educational programme would be successful in improving the undergraduate nursing students'~     EBP knowledge and beliefs and, and the extent of their EBP implementation This will be tested~     using a prospective cluster randomized control trial with two-armed parallel group design.~   "
11854|NCT03411655|"~     The investigators test the hypothesis that fiberoptic intubation (time and success rate)~     differ between the Ambu® Aura-ITM and Ambu Aura GainTM in paralyzed anaesthetized pediatric~     patients~   "
11922|NCT03410758|"~     Prospective study of Predictive Factors of Survival With and Without Repetition With 5 and 10~     Years Curative Post-oesophagectomy for Cancer of the Oesophagus~   "
11856|NCT03411629|"~     Acute pancreatitis is an inflammatory process which causes a local and systemic inflammatory~     response syndrome (SIRS). Although the majority of patients have a mild disease course,~     around 20% will develop moderate or severe pancreatitis, with necrosis of the (peri)~     pancreatic tissue and/or multiple-organ failure. Previous studies have correlated colonic~     involvement as a prognostic marker in acute pancreatitis. It is well known that translocation~     of the colonic flora may significantly influence the clinical course of patients with acute~     pancreatitis. The correlation between collection(s) around colon in CT finding and clinical~     outcomes has not been studied in necrotizing pancreatitis. In current study, the~     investigators will do a prospective observational study correlating collection(s) around the~     colon and clinical course of patients in acute necrotizing pancreatitis.~   "
11857|NCT03411616|"~     Excessive weight gain, obesity and metabolic syndrome are highly prevalent in patients~     undergoing liver transplantation. Traditional methods of assessing dietary intake have failed~     to demonstrate an association between these problems and dietary intake. Patients with an~     indication for transplantation due to ethanolic cirrhosis, ex-smokers and those with a~     previous history of overweight were identified as being at greater risk for overweight and~     metabolic syndrome, and these factors may be related to the change in eating behavior after~     the operation. Objective: To evaluate the eating behavior, the occurrence of food craving and~     relation to weight gain, overweight and obesity after liver transplantation. Method: This is~     a cross-sectional study in which adult and elderly patients in follow-up at the Hepatic~     Transplant Outpatient Clinic of the Alpha Institute of Gastroenterology of the Federal~     University of Minas Gerais were evaluated for eating behavior and food craving. The~     evaluation of the eating behavior was performed with the help of the Three Factor Eating~     Questionnaire-R21 (TFEQ-R21), translated version and validated for Portuguese. Food Craving~     Questionnaires State (FCQ-S) and Trait (FCQ-T) and the Brazilian Inventory of Foods Related~     to Craving (FCI-Br) were used in the translated and validated versions for Portuguese.~     Demographic, lifestyle, clinical and anthropometric variables of the evaluated patients were~     obtained through electronic medical records. Weight gain was assessed by the difference~     between the current weight and the first post-transplant outpatient weight.~   "
11858|NCT03411603|"~     The objectives of the study are to assess the validity of Nestlé reformulation criteria in~     two national dietary surveys: the US NHANES 2011, and the French INCA2 2006-07.~   "
11859|NCT03411590|"~     It is well known than an important part of Nigerian children from the lower social economic~     class have nutrient deficiencies. Fortified products, such as growing up milks (GUM), may~     play an important role in reducing the risk and incidence of nutrient deficiencies. However,~     affordability of GUM is an issue.~      In this project the effects are studied of different daily intakes of GUM on iron status,~     growth, several other nutrient status parameters in blood and urine, cognitive development,~     and the intestinal microbiome in Nigerian toddlers 1-3 years of age.~      The project is a collaboration with the department of Paediatrics and Child health of the~     Lagos State University College of Medicine in Lagos. The design is based on a three-arm, open~     (partly blind: statistics, biochemical analyses), randomized intervention trial. Recruitment~     will take place in Ijora-Badia community in Apapa-Iganmu Local Council Development Area~     (LCDA) in Lagos. The three groups will be given a multi-micronutrient fortified growing-up~     milk (PEAK), in amounts of 200, 400 or 600 ml per day during a period of 6 months. Primary~     objective of this study is to reduce iron deficiency anemia. Based on this objective, in~     total 150 children have to be included in this study.~   "
11860|NCT03411577|"~     Caribbean nations, including Jamaica, exhibit HIV rates that are second only to sub-Saharan~     Africa. Jamaican young women and adolescent girls are at particularly high risk due to a~     number of cultural factors, gender norms, partnering with older male partners, and lack of~     knowledge and skills related to sexual refusal and HIV prevention. U.S. studies have shown~     that mothers may act as a key influence of their daughters' sexual risk beliefs and~     behaviors. However, no such studies have documented these effects outside of the U.S. and no~     studies have evaluated HIV risk-reduction interventions with Jamaican adolescent girls and~     their mothers. Hence, the purpose of this study is to partner with the University of the West~     Indies, Jamaican community based organizations (CBOs) and families in order to develop and~     test a culture-specific mother-daughter HIV risk-reduction intervention in a randomized field~     experiment. Specifically, the investigative team will evaluate whether a culture-specific,~     theory-based, skill-building intervention with Jamaican adolescent girls and their mothers~     can directly and/or indirectly reduce these girls' HIV risk-associated sexual behaviors.~     Jamaican girls, ages 13 - 17, and their mothers/female guardians will be recruited from CBOs~     and randomly assigned to either: (a) a mother-daughter HIV risk-reduction intervention~     condition or (b) a no intervention waitlist control condition. The HIV risk-reduction~     intervention includes 12 1-hour modules scheduled over 2 days and implemented by trained~     adult Jamaican women (nurses and CBO staff). The mother component is designed to increase~     those parenting behaviors (e.g., monitoring and parent-teen sexual risk communication~     [PTSRC]) associated with reduced adolescent sexual risk-taking; the teen component is~     designed to improve girls' beliefs and skills related to abstinence, sexual negotiation and~     condom use. A waitlist control condition is being employed as the proposed project is a~     pilot study of the HIV risk-reduction intervention. Primary outcomes include~     mothers'/daughters' reports of parenting behaviors (monitoring and PTSRC) and daughters'~     self-reports of sexual risk behaviors (sexual intercourse, unprotected sex, condom use,~     number of partners). Secondary outcomes include daughters' STI rates, mothers' beliefs~     regarding parenting behaviors and daughters beliefs regarding sexual risk behaviors.~   "
11861|NCT03411564|"~     Lights4Violence aims to promote adolescents' capabilities to improve their intimate~     relationships with peers through different participation approach activities. In order to do~     that, it is planned to perform a longitudinal quasi-experimental educational intervention~     study with a quantitative evaluation in 5 different cities: Alicante (Spain), Cardiff (UK),~     Porto (Portugal), Iasi (Romania) and Lublin (Poland) between 2018 and 2019.~   "
11862|NCT03411551|"~     By means of an observer-blinded, randomized controlled trial, the analgesic efficacy of the~     forearm intravenous regional anesthesia and the ultrasound guided peripheral nerve block will~     be investigated in patients undergoing carpal tunnel release. The hypothesis is that the~     ultrasound-guided peripheral nerve block is superior compared to the forearm intravenous~     regional anesthesia with respect to the analgesic efficacy.~      Furthermore, pre-, intra-, and post-operative pain will be investigated at several time~     points as well as general patient satisfaction and satisfaction of the surgeon regarding the~     procedures.~   "
11863|NCT03411538|"~     This is a prospective surveillance study to estimate excess deaths due to and risk factors~     associated with antibiotic-resistant infection among patients with hospital-acquired~     infection (HAI) in a resource-limited setting. We will focus on six pathogenic bacteria that~     are of clinically important in the hospital.~   "
11923|NCT03410745|"~     This study will examine the effect of exercise on the turnover of collagen in articular~     cartilage and the content of cytokines in the synovial fluid from human adults with~     osteoarthritis.~   "
19769|NCT03308214|"~     The study measures the plasma concentrations of imipenem in septic shock patients and~     non-septic shock patients and observes hypoalbuminemia and the impact of the severity of~     critical illness on Vd~   "
11864|NCT03411525|"~     Clinicians' decisions to order potentially unnecessary services -- such as those targeted in~     the Choosing Wisely® campaign -- are often affected by their high-pressure practice~     environments, which can make it hard to consistently avoid ordering low-value care. The field~     of behavioral economics offers a promising and highly scalable approach to decreasing use of~     low-value services: asking clinicians to commit to avoid ordering such services and providing~     them and their patients with resources to support adherence to this commitment. This project~     will evaluate the effects of such an intervention across 2 large health systems, Michigan~     Medicine and IHA, through a mixed-methods, stepped wedge cluster randomized trial. In each of~     the study clinics, clinicians will be invited to commit to following a set of targeted~     Choosing Wisely® recommendations. Clinicians who make such a commitment, and their patients,~     will receive access to key resources to support adherence to this commitment. To measure the~     effects of the intervention, automated clinical data and medical record data before and after~     the intervention will be examined. Surveys and semi-structured interviews of both clinicians~     and patients will also be conducted to determine the effects of the intervention on their~     decision-making and experiences.~   "
11865|NCT03411512|"~     Congenital Heart Defects and NIRS~   "
11866|NCT03411499|"~     The purpose of the EARLY study is to evaluate the efficacy and effectiveness of early surgery~     in patients with Infective Endocarditis (IE).~   "
11867|NCT03411473|"~     A Phase IIa Open-Label Trial to Investigate the Safety, Tolerability, Pharmacokinetics,~     Biological, and Clinical Activity of AGEN1884 in Combination with Pembrolizumab in Subjects~     with Chemotherapy Naïve, PD-L1 high, metastatic Non-Small Cell Lung Cancer (NSCLC)~   "
11868|NCT03411460|"~     The aim of the study is to establish whether routine usage of the FreeStyle Libre™ system~     (Abbott) improves satisfaction and quality of sleep in patients hospitalized for poor~     glycemic control with an indication for external insulin pump treatment.~   "
11869|NCT03411447|"~     To evaluate the impact of enteral nutrition on microaspiration of gastric content and~     pharyngeal secretions~   "
11870|NCT03411434|"~     ADHD is a neurodevelopmental disorder characterized by symptoms of inattention and / or~     hyperactivity-impulsivity that affects nearly 6% of school-aged children and persists into~     adulthood. More and more studies are interested in biomarkers of this pathology. The~     oculomotricity, which allows to highlight deficits motor and attention present in ADHD, is~     used routinely in the expert centers. In general, the pharmacological treatment of ADHD is~     associated with a clinical response in approximately 70% of cases. Today, there is no review~     to predict the individual response to treatment.~      Hypotheses The investigators hypothesize that a precise analysis of the oculomotor markers~     will allow to measure the improvement of the symptomatology of the ADHD disorder following~     the introduction of the psycho-stimulatory treatment. In other words, the investigators~     hypothesize that these markers could be a useful aid in patient follow-up by the clinician~     and allow early identification of responder and non-responder patients.~      Primary objective The main objective of this study is to measure the added value of~     oculomotor examination in the follow-up of psycho-stimulant-treated ADHD patients.~      Main Evaluation Criteria The primary endpoint is oculomotor performance. Parameters analyzed~     for each saccade are latency, amplitude, duration, average speed, direction.~      Secondary Criteria Evaluation (s) Correlations will be established between oculomotor data~     and scores obtained at the clinical scales assessing ADHD symptoms of inattention and~     hyperactivity as well as cognitive performance. The data obtained before the introduction of~     the psycho-stimulant treatment (V0, baseline) will be compared with those obtained after~     acute administration of methylphenidate (10 mg orally,V1) and during the follow-up visit at 6~     months (V2).~   "
11871|NCT03411421|"~     The purpose of this study is to evaluate the safety and tolerability (including incidence of~     central nervous system [CNS] related events such as lightheadedness and dizziness), of~     multiple oral doses of AL-794 in healthy volunteers (HV). Also, to evaluate the~     pharmacokinetics of ALS-033719 and ALS-033927 in plasma after multiple oral doses of AL-794~     in HV.~   "
11872|NCT03411408|"~     This is a pilot study of radiotherapy using Hypofractionated image - guided helical~     tomotherapy after hyperbaric oxygen HBO therapy for treatment of recurrent malignant~     High-grade gliomas. HBO therapy will be perform in conjunction with each RT session.~      The treatment scheme is:~      Hyperbaric oxygenation therapy (the maximum period of time from completion of decompression~     to RT is 60 min) followed by tomotherapy (3-5 consecutive sessions- one fraction per day , 5~     Gy / die ).~      The trial will enroll 24 patients in 24 months with a follow-up period of 1 year.~   "
11873|NCT03411395|"~     It has previously been shown that a carbonated water including a defined amount of amino~     acids and chromium can decrease the postprandial glucose response. In this study, the effect~     of three different doses of amino acids on glucose excursions after a standardized test meal~     will be evaluated in healthy subjects. The study will be conducted in a randomized, single~     center, crossover, double-blinded, placebo controlled design including 25 participants. The~     primary endpoint of the study is the incremental area under the curve for capillary blood~     glucose (iAUC) within 180 minutes after ingestion of the meal.~   "
11874|NCT03411382|"~     Objective: The study aims to understand the physical function, body composition, mental~     state, behavior, depression, and life quality change of the elderly in a long-term care~     before and after the intervention. Four interventional activities are sitting strength~     training, games, sitting strength training with games, and health education.~   "
11875|NCT03411369|"~     Recently, researchers have paid attention to the development of new products such as~     supplements food and nutraceuticals for identify and develop integrative therapies to be used~     in cardiovascular disease. As suggested by literature, some nutritional components (creatine,~     ribose) can enhance the fundamental energy levels for the functioning of the heart muscle and~     can enhance the body's antioxidant capacity through the reduction in free radicals activity,~     one of the main pathogenic mechanisms of these diseases. In this context, the investigators~     have developed a research with the principal purpose to establish whether a supplement of~     creatine and ribose can improve the total work capacity during exercise in a population of~     patients with known ischemic heart disease.~   "
12173|NCT03407482|"~     This Phase II, multicenter, open-label extension (OLE) study will evaluate the long-term~     safety and efficacy of GDC-0853 in participants with systemic lupus erythematosus (SLE) who~     have completed Study GA30044 (NCT02908100) up to 48 weeks.~   "
11877|NCT03411343|"~     Interscalene brachial plexus block constitutes the analgesic criterion standard for shoulder~     surgery. However, it is associated with a high incidence of hemidiaphragmatic paralysis (HDP)~     that may not be tolerated by patients with chronic pulmonary disease. This randomized~     controlled trial (RCT) will compare ultrasound-guided interscalene block (ISB) and~     costoclavicular infraclavicular block (CCICB) in patients undergoing arthroscopic shoulder~     surgery.~      The main outcome is static pain at 30 minutes after arrival in the post anesthesia care unit~     (PACU) as measured by a numerical rate scale (NRS) from 0 to 10. Our research hypothesis is~     that interscalene and costoclavicular infraclavicular blocks will result in equivalent~     postoperative analgesia at 30 minutes in the PACU. The equivalence margin is set at 2 points.~   "
11878|NCT03411330|"~     Safety and efficacy of addition of hyaluronidase to lidocaine and bupivacaine in scalp nerves~     block in elective craniotomy operations,Comparative study~   "
11879|NCT03411317|"~     Aortic stenosis (AS) is the most frequent valvulopathy in Western countries. The prevalence~     of AS is constantly increasing due to the aging of the population. Although significant~     progress has been made in understanding the pathophysiological mechanisms underlying the~     onset and progression of AS, there is no medical treatment to slow or prevent its~     progression. The only treatment available is Aortic Valve Replacement (AVR) performed by~     surgery or by catheterization (TAVI).~      AS is associated with an increase of post-load which leads the left ventricular myocardium to~     hypertrophy. Associated with hypertrophy, myocardial fibrosis will gradually develop. Despite~     interesting data, many unknowns persist and remain to be identified.~      The aim of the study is to evaluate prospectively the progression and impact of AS in 500~     patients using clinical, biological, echocardiographic and MRI parameters performed annually.~   "
11880|NCT03411304|"~     Aortic stenosis (AS) is the most frequent valvulopathy in Western countries. The prevalence~     of AS is constantly increasing due to the aging of the population. Although significant~     progress has been made in understanding the pathophysiological mechanisms underlying the~     onset and progression of AS, there is no medical treatment to slow or prevent its~     progression. The only treatment available is Aortic Valve Replacement (AVR) performed by~     surgery or by catheterization (TAVI).~      AS is associated with an increase of post-load which leads the left ventricular myocardium to~     hypertrophy. Associated with hypertrophy, myocardial fibrosis will gradually develop. Despite~     interesting data, many unknowns persist and remain to be identified.~      The aim of the study is to characterize prospectively the left ventricular remodeling and~     assess its changes after AVR and within 1 year in 500 patients using clinical, biological,~     echocardiographic and MRI parameters.~   "
11881|NCT03411291|"~     Specific Aim: Demonstrate that statins have an effect on cerebral blood flow and neuronal~     activity~   "
11882|NCT03411278|"~     The purpose of this study is to evaluate the effects of Deep Oscillation (DO) self-treatment~     on recovery after fatiguing soccer training. We investigate deep oscillation (DO) self~     treatment as a measure to promote regeneration, hypothesizing that DO leads to an accelerated~     recovery within the first 48h after fatiguing training with positive effect on the maximum~     strength, rated perceived exertion, creatinkinase (CK) values and DOMS compared to no~     treatment after an .~   "
11883|NCT03411265|"~     The purpose of this research study is to:~        1. assess how well individuals entering medication assisted treatment like the RETAIN~          e-health application as measured by their feedback on the intervention.~        2. test the impact of RETAIN on knowledge about medication-assisted treatment(MAT).~        3. assess treatment retention rates in patients completing the RETAIN intervention.~        4. test the impact of RETAIN on knowledge about HCV/HIV~        5. test the impact of RETAIN on interest in being tested for HCV/HIV~   "
11884|NCT03411252|"~     This study evaluates whether a medication called mirabegron is better than placebo (sugar~     pill) in helping patients with achalasia swallow better. Each patient will receive either~     mirabegron or the placebo for 4 weeks followed by the opposite medication. Each patient will~     complete several surveys and undergo several tests to determine if the mirabegron is helping~     reduce the pressures in the esophagus (swallowing tube).~   "
11885|NCT03411239|"~     This is a single centre study. We intend to recruit 20 subjects over 4 months. Patients~     undergoing laparoscopic abdominal surgery for cholecystectomy, laparoscopic gynaecological~     surgery and laparoscopic urologic procedures either as day surgery, same day admission or in~     patients, will be included in the study. Patients will be identified at the time of listing~     for surgery and referred to study team, which in turn will recruit the patients. Informed~     consent will be obtained at the time of recruitment and a copy of consent with details of~     principal investigator would be provided to subjects. All data collection will be done~     intraoperative. Patient would be followed up once at day 3 post op period. If patients have~     any complications related to the study, they will be followed up weekly until the~     complication is resolved.~   "
11886|NCT03411226|"~     The Trans REctussheath PrePeritoneal (TREPP) mesh repair was introduced in 2006 to decrease~     the risk of postoperative inguinal pain in hernia surgery. For the repair of a recurrent~     inguinal hernia after a primary TREPP an alternative open anterior route (Lichtenstein) may~     seem the most logical option, but coincides with an increased risk of chronic postoperative~     inguinal pain. Therefore, this study aimed to evaluate the feasibility of a second TREPP~     procedure to repair a recurrent inguinal hernia after an initial TREPP repair. The hypothesis~     was that the technique is possible and does not lead to an increased risk of postoperative~     pain.~   "
11924|NCT03410732|"~     Study objectives are to investigate the efficacy and safety of activated autologous dendritic~     cells (DCs) in treatment of gastric cancer. DCs are activated by the proteins from autologous~     tumor cell membrane and cytokines in vitro. The efficacy endpoints include objective~     response, immune-cell response, recurrent rate after a radical surgery, progression-free~     survival and overall survival, and the safety endpoints include adverse events, laboratory~     tests, ECG, ECOG-PT, etc.~   "
11925|NCT03410719|"~     the aim of this study is to evaluate whether a Mediterranean diet rich in pasta and other~     starchy foods with a (Low-GI), as compared with a similar Mediterranean diet containing very~     little pasta and based on starchy foods with a (Hi-GI) is able to reduce insulin and glucose~     concentrations during a prolonged test study meal.~   "
14554|NCT03376425|"~     This study aims to provide the information of tissue elasticity in different etiologies of~     pulmonary lesions and to validate the predictive value of shear-wave elastography in~     differentiating benign pulmonary lesions from malignant lesions.~   "
11887|NCT03411213|"~     Atherosclerosis is accompanied by microvascular dysfunction (an impairment of blood vessels~     to dilate or constrict in response to demand). The ability to reliably measure microvascular~     dysfunction would help identify patients at risk of myocardial infarction and test new~     treatments. All existing measures of microvascular dysfunction suffer significant~     limitations.~      Near Infrared Spectroscopy (NIRS) is an imaging method that uses an infrared light-source and~     detector (called optodes) to painlessly shines light into tissue and collect reflected light~     at different wavelengths. This data allows quantification of the amount of haemoglobin~     (blood) in the tissue and whether it is oxygenated or de-oxygenated.~      Diffuse optical tomography (DOT) is a powerful analysis technique for data collected from~     multiple NIRH optodes. Unlike most NIRS studies that use a single pair of optodes and~     collects a single datapoint for each wavelength over time, DOT allows three-dimensional~     spatial reconstruction of haemodynamic and anatomic changes in a large region of tissue over~     time.~      In preliminary work DOT had the potential to measure forearm reactive hyperaemia, a key~     indicator of microvascular function. Team will test whether DOT can detect differences~     between patients and healthy volunteers.~      In this work, 30 patients will be recruited with type 2 diabetes, 30 patients who have had a~     previous myocardial infarction and 30 healthy volunteers. The Investigator will also recruit~     50 patients who are on waiting lists for coronary angiography.~      The DOT will be used to measure participants' microvascular function after brachial artery~     occlusion by a blood pressure cuff. The Investigator will then examine whether DOT can detect~     differences between healthy volunteers, diabetics, and patients with a previous heart attack,~     and whether DOT is able to predict existence of coronary artery disease on angiography. If~     successful, DOT can be developed for assessment of microvascular function to the point where~     it could be applied to clinical studies.~   "
11888|NCT03411200|"~     PACE-Mobil-PBL is a prospective randomized controlled trial. The aim is to investigate the~     effect of a multimodal and exercise-based intervention among older patients with advanced~     pancreatic cancer, biliary tract cancer, or lung cancer during treatment with first-line~     palliative chemotherapy, immunotherapy or targeted therapy.~      The hypotheses: That the multimodal intervention will increase or maintain physical function~     levels and strength, reduce symptoms and side-effects, improve quality of life, reduce~     treatment-related complications and hospital admissions, and reduce risk of cancer cachexia~     and sarcopenia.~   "
11889|NCT03411187|"~     Endoscopic thyroidectomy developed rapidly in recent years, and the most popular surgical~     approach was endoscopic thyroidectomy by bilateral areola approach, but some operative steps~     was required optimization. One of the most annoying problem was the smog blurring endoscopic~     lens during surgery. The researcher summarized a set of convenient foot-control exhaust~     method and carried out this prospective study.~   "
11890|NCT03411174|"~     The study was designed to evaluate the feasibility and safety of hypofractionated partial~     breast irradiation after breast-conserving surgery for low-risk breast cancer patients.~   "
11891|NCT03411161|"~     The purpose of this study is to determine the safety profile, the maximum tolerated dose~     (MTD) and the associated dose-limiting toxicities (DLTs) of S 81694 in combination with~     paclitaxel in metastatic breast cancer (mBC) patients, and to investigate the antitumour~     activity of the combination in metastatic triple negative breast cancer (mTNBC) patients.~   "
11892|NCT03411148|"~     Low balance confidence occurs when an individual perceives they have limited ability to~     maintain their balance while performing a specific task of daily living. It is a prevalent~     problem in lower limb prosthesis users and is a strong predictor of prosthesis use and~     community participation. Balance confidence is not necessarily related to functional~     abilities. It is possible to improve functional ability as a result of rehabilitation,~     without concurrently improving balance confidence. Interventions to address low balance~     confidence may need to target both functional abilities as well as beliefs regarding these~     abilities. The purpose of this study is to test whether, for users of lower limb prostheses,~     an intervention combining physical therapy exercise to improve function with cognitive~     behavioral therapy to address fears and thoughts associated with low confidence can improve~     balance confidence and promote community participation.~   "
11893|NCT03411135|"~     All patients with vitiligo attending dermatology outpatient clinic at Kasr Alainy Teaching~     Hospital will be enrolled in this study to compare VES and VASI scores and evaluate them as~     assessment methods~   "
11894|NCT03411122|"~     This is a phase I, single-center, open-label, single-sequence, 3-period, PK drug interaction~     study evaluating the effect of napabucasin in healthy volunteers on the single-dose PK of~     several cytochrome P450 (CYP450) probe drugs as well as a BCRP substrate.~   "
11895|NCT03411109|"~     Multimodal analgesia, sometimes including intrathecal analgesia (IA), is essential in any~     enhanced recovery pathway (ERP). This study aimed to evaluate the safety, feasibility, and~     optimal IA regimen in colorectal surgical patients.~   "
11896|NCT03411096|"~     Opioid analgesics have many side effects. Quadratus lumborum (QL) block is one kind of~     regional nerve block that can reduce the side effects of opioid analgesics. The investigators~     hypothesize that QL block with local analgesics (ropivacaine) can significantly reduce pain~     intensity in comparison with placebo.~   "
11897|NCT03411083|"~     In this cohort study, we will investigate short and long term outcomes after knee replacement~     surgery and identify preoperative and early postoperative factors associated with long term~     outcome.~   "
11898|NCT03411070|"~     This pilot clinical trial studies how well radiofrequency tagged surgery works in treating~     patients with breast cancer. Tagging radiofrequency markers to lymph nodes in the area of the~     armpit (axilla) to which cancer has spread may help doctors more accurately identify lymph~     nodes for removal.~   "
11899|NCT03411057|"~     This study will assess the mental health and clinical benefits of Mindfulness Based Stress~     Reduction (MBSR) in patients with rheumatoid arthritis who have anxiety or depression. MBSR,~     an interactive form of meditation that includes gentle yoga, will be taught by a certified~     instructor over an eight-week period. Mental health surveys will be conducted within one~     month of the study start and end as well as mid-course. Clinical assessments will be~     conducted within one-month of the study start and end.~   "
11900|NCT03411044|"~     A multi-centre, non-comparative, prospective post-market clinical follow-up study to obtain~     survival, clinical and radiographic outcomes data on the Zimmer Fitmore Hip Stem.~   "
11901|NCT03411031|"~     The purpose of this study is determine Time-to-Progression with elotuzumab plus lenalidomide~     when elotuzumab is added to multiple myeloma participants with serologic relapse/progression~     while receiving lenalidomide maintenance for each study arm.~   "
11902|NCT03411018|"~     This observational study evaluates the impact of respiratory management modifications~     implemented in our institution on the intubation rates and the death or Bronchopulmonary~     Dysplasia (BPD) outcome.~   "
46122|NCT02963168|"~     This is a nonrandomized, open-label, dose escalation, safety, activity, and PK study to~     determine the MTD and optimal dosing regimen of Oradoxel. No control group has been included.~   "
11903|NCT03411005|"~     Protein is the key determinant of growth and bodily functions. The quality of food proteins~     depend on their amino acid content and the amount of amino acids used by the body to make~     proteins. Globally Cereal Grains (CG) provide 50% of the calories and protein in the diet and~     exceed 80% in poorer developing countries. In many of those countries, sorghum is the major~     cereal grain in the diet. The protein in sorghum is low in the essential amino acid lysine.~     Hence sorghum protein is of low quality. Low lysine affects protein synthesis in the body.~     Cooking methods also affect the lysine available from foods to the body.The protein can be~     complemented by the addition of lentils to augment the low lysine content. However, lentils~     are prohibitively expensive in some developing countries.~      As the human population increases, the world faces the continuous challenge of maximizing a~     limited food supply. Protein quality (PQ) evaluation of sorghum directly in humans would~     allow us to bridge the gap in knowledge between what is required and how best to provide.The~     information gathered from this project will provide the first direct experimental data on PQ~     of sorghum protein in humans on which nutrition recommendations can be built.~   "
11904|NCT03410992|"~     Phase 3 study to compare the efficacy of bimekizumab versus placebo in the treatment of~     subjects with moderate to severe chronic plaque psoriasis.~   "
11905|NCT03410979|"~     This study is a first-in-human (FIH), Phase I, single center, randomized, double-blind,~     placebo-controlled, sequential group study in healthy male subjects to assess the safety,~     tolerability and PK of single ascending oral doses of GLPG2737 and multiple ascending oral~     doses of GLPG2737 administered for 14 days.~   "
11906|NCT03410966|"~     Objective. Atrial fibrillation (AF) recurrence after catheter ablation (CA) is a relevant~     clinical problem.~      Methods. 123 patients with paroxysmal AF will be identified and screened for participation in~     this randomized, prospective, double blind, controlled placebo multicenter trial. 109~     patients will be randomly assigned and enrolled in the study trial. Enrolled patients will~     receive magnetic atrial resonance and then will be treated by CA to receive pulmonary vein~     isolation (PVI). In this patients cytokines, inflammatory markers, and biomarkers such as ST2~     protein and B type natriuretic peptide (BNP) will be evaluated at baseline, after CA, and~     during follow up. These biomarkers will be correlated to clinical outcomes (AF recurrences~     and heart failure progression and hospitalizations), and to fibrotic atrium extension as~     evaluated by magnetic resonance.~   "
11907|NCT03410953|"~     Health workers with biological risk in their tasks, who have been vaccinated as~     non-responders to conventional vaccination against Hepatitis B. To provide Health~     workers-staff with an additional protection tool against hepatitis B infection. To evaluate~     the efficacy of the adjuvanted vaccine in healthy nonresponders to conventional hepatitis B~     vaccine~   "
11908|NCT03410940|"~     This study is a multi-center, prospective, non-controlled post-market surveillance study. The~     primary objective of this study is to confirm the safety and performance of the CLS Brevius~     stem with Kinectiv technology by obtaining implant survivorship and clinical outcomes data~     for the commercially available stem.~   "
11909|NCT03410927|"~     This is a First-in-Human (FIH), 2-part, Phase 1/2, open-label, multicenter study design to~     evaluate the safety, tolerability, PK, pharmacodynamics, PGx, and efficacy of TAS0728. This~     study consists of Phase 1 and Phase 2a components in subjects with advanced solid tumors with~     HER2 or HER3 overexpression, amplification, or mutation who have progressed despite standard~     therapy or for which no standard therapy exists, particularly urothelial cancer, biliary~     tract cancer, metastatic breast cancer, non-small cell lung cancer and colorectal cancer.~   "
11910|NCT03410914|"~     Despite improvements and advances in pancreas surgery, about 30-35% of patients who have~     pancreas surgery develop a type of complication called a pancreatic fistula. A pancreatic~     fistula occurs when fluid produced by the pancreas leaks into the abdomen after pancreas~     surgery. Patients who develop a pancreatic fistula can have poor short-term and long-term~     consequences.We are studying the effect of a medical device named HEMOPATCH on the~     development and seriousness of pancreatic fistulas. HEMOPATCH is a thin, flexible bovine~     protein-based pad that may improve tissue sealing where it is applied during surgery. Some~     small studies called case studies of between 2 and 7 patients, and two clinical trials have~     shown that HEMOPATCH is effective at stopping bleeding and reducing drain output after some~     types of surgery. However, there have been no completed clinical trials using HEMOPATCH to~     prevent or reduce pancreatic fistulas in patients having pancreas surgery, so we don't know~     if it works in this setting. Health Canada has approved the use of HEMOPATCH as a device to~     stop bleeding or seal other bodily fluids for procedures in which the control of bleeding or~     leakage of other body fluids or air by standard surgical techniques are either ineffective or~     impractical.~   "
11911|NCT03410901|"~     This phase I trial studies the side effects and best dose of the anti-OX40 antibody~     BMS-986178 when given together with the TLR9 agonist SD-101 and radiation therapy in treating~     patients with low-grade B-cell Non-Hodgkin lymphomas. TLR9 agonist SD-101 may stimulate the~     immune system in different ways and stop cancer cells from growing. Anti-OX40 antibody is a~     monoclonal antibody that enhances the activation of T cells, immune cells that are important~     for fighting tumors Radiation therapy uses high energy x-rays to kill cancer cells and may~     make them more easily detected by the immune system. Giving TLR9 agonist SD-101 together with~     anti-OX40 antibody BMS 986178 and radiation therapy may work better in treating patients with~     low-grade B-cell non-hodgkin lymphomas.~   "
11912|NCT03410888|"~     Study Hypothesis The investigators approach to demonstrate noninferiority of analgesia~     provided by popliteal block in TKA surgery will be based on a hypothesis of absence of a~     clinically significant difference in pain visual analogue sores (VAS) between the analgesia~     provided by the popliteal block and that of the infragluteal sciatic block in TKA surgery~     patients.~   "
11926|NCT03410706|"~     EINSTEIN PE study demonstrated that rivaroxaban is at least as effective as the current~     standard therapy with 51% relative risk reduction of major bleeding (1.1% vs. 2.2%, HR 0.49,~     95% CI, 0.31-0.79), in the treatment and secondary prevention of PE. However these patients~     were required to meet strict eligibility criteria. Little is known about PE treatment in~     China in routine clinical practice and in a real world study patients at higher or lower risk~     for adverse events can possibly recruited. Bayer conducts this study to yield~     post-authorization safety information in rivaroxaban under real-life conditions in China.~   "
11913|NCT03410875|"~     This is a multi-center, open label, single arm, phase II trial of the oral BRAF inhibitor,~     vemurafenib, plus obinutuzumab in patients with previously untreated HCL. A Simon mini-max~     two-stage design will be employed to assess the efficacy of the combination treatment of~     vemurafenib and obinutuzumab. In the first stage of the protocol, 9 patients will be treated.~     If fewer than 6 CRs are seen among the first 9 patients, the study will be closed for lack of~     efficacy. If at least 7 patients respond to the treatment, then an additional 19 patients~     will be accrued to the second stage, for a total of 28 patients.~      Eligible patients will receive vemurafenib at a dose of 960mg orally twice daily (b.i.d.)~     continuously in cycles of 4 weeks (28 days) for a total of 4 cycles.~      Obinutuzumab will be administered concomitantly with vemurafenib starting at cycle 2 of~     treatment in cycles of 4 weeks. Obinutuzumab infusions will be administered at 1000mg per day~     on days 1, 8 and 15 during the cycle 2 and 1000mg per day every 4 weeks during the cycle 3~     and 4 of treatment. After the completion of the treatment (i.e. after 4 cycles), a bone~     marrow aspirate and biopsy will be performed for assessment of response and evaluation of~     minimal residual disease (MRD). In case of certain defined toxicities, dose reductions of~     vemurafenib by 50% (480mg b.i.d.) or interruptions of up to 15 days are permitted. If~     additional dose reduction is required, vemurafenib may be reduced to 240mg oral b.i.d.~   "
11914|NCT03410862|"~     This research is being done to determine if an extract of cooked elderberries will help~     decrease the duration and severity of influenza symptoms in patients with confirmed~     influenza. Involvement in this study requires an initial patient screening at the time of~     their Emergency Department visit in order to confirm eligibility for the study. Once patients~     have been consented and enrolled as a participant, they will be randomized to take by mouth~     either Elderberry Extract or a placebo (a similar appearing and tasting liquid without~     elderberry) for a duration of 5 days. Study information regarding medication adherence, body~     temperature, symptoms, severity of symptoms, and any possible side effects will be collected~     from daily phone surveys conducted by the study coordinator. Participation in the study will~     end after at least 5 days once the patient has not had a temperature above 100°F and has had~     no influenza symptoms for at least 24 hours, or after 21 days in the study, whichever occurs~     first.~   "
11915|NCT03410849|"~     The goal of this trial is to examine long-term effects of laparoscopic gastric bypass (LRYGB)~     and sleeve gastrectomy (LSG) on oesophageal symptoms and disease, including the presence of~     Barrett oesophagus ≥ 5 years post-surgery.~   "
11916|NCT03410836|"~     This study evaluates the impact of intraoperative intravenous lidocaine administered during~     laparoscopic colorectal surgery on the intraoperative remifentanil consumption as well as~     postoperative pain and opioid requirements. It will evaluate immune cell activity for 48hours~     after surgical stress and general anesthesia with or without intravenous lidocaine.~   "
11917|NCT03410823|"~     Hip fracture is a common problem among older individuals. The goal of current standard of~     care after hip fracture is to achieve independent, household ambulation 2-3 months after~     surgery, yet decreased functional ability typically persists well beyond three months and~     many patients never resume independent ambulation outside the home. Previous research has~     established that one must be able to walk at least 300 meters (~330 yards) within 6 minutes~     to re-establish routine interactions in the community, such as going to the store or to~     church. In part, this is based on the average distance from handicapped parking spaces into~     most facilities. Activity and exercise are believed to be of benefit for reducing disability~     in older adults, yet the majority of older adults does not participate in regular exercise~     and is not active. This is especially true for older adults following hip fracture after they~     complete the usual rehabilitation program.~      This research study is being done to test a 16-week, multi-part exercise intervention for hip~     fracture patients that will be supervised by specially trained physical therapists (PTs). The~     exercise intervention uses a novel machine to provide strength and endurance training in the~     home. This has been shown in smaller studies to be safe and effective at increasing strength.~     The purpose of this small pilot study is to test whether adding a protein supplement to the~     exercise intervention leads to more improvements in a person's ability to walk in their own~     home and in the local community. With this knowledge, investigators hope to help a greater~     number of hip fracture patients enjoy a more complete recovery and improved overall health.~      In addition to providing important information on adherence, feasibility, and safety, this~     pilot study of hip fracture patients has the unique advantage of being able to compare data~     to two recently completed studies where participants received the PUSH intervention without~     protein supplementation.~   "
11918|NCT03410810|"~     Prematurely born children are at higher risk of cognitive impairments and behavioral~     disorders than full-term children. There is growing evidence of significant volumetric and~     shape abnormalities in subcortical structures of premature neonates, which may be associated~     to negative long-term neurodevelopmental outcomes. The general objective is to look directly~     at the long-term neurodevelopmental implications of these neonatal subcortical structures~     abnormalities. Investigators propose to develop biomarkers of prematurity by comparing the~     morphological and diffusion properties of subcortical structures between preterm, with and~     without associated brain injuries, and full-term neonates using brain MRI. By combining~     subcortical morphological and diffusion properties, investigators hypothesize to be able to:~     (1) delineate specific correlative relationships between structures regionally and~     differentially affected by normal maturation and different patterns of white matter injury,~     and (2) improve the specificity of neuroimaging to predict neurodevelopmental outcomes~     earlier. The specific aims and general methodology are: 1) Build a new toolbox for neonatal~     subcortical structures analyses that combine a group lasso-based analysis of significant~     regions of shape changes, a structural correlation network analysis, a neonatal tractography,~     and tensor-based analysis on tracts; 2) Ascertain biomarkers of prematurity in neonates with~     different patterns of abnormalities using correlational and connectivity analysis within and~     between structures features; 3) Assess the predictive potential of subcortical imaging on~     neurodevelopmental outcomes by correlating neonatal imaging results with long-term~     neurodevelopmental scores at 9 and 18 months, and 6-8 years, follow-up. In each of these~     aims, investigators will use advanced neuroimaging analysis developed by their group and~     collaborator, including multivariate tensor-based morphometry and multivariate tract-based~     analysis. This application will provide the first complete subcortical network analysis in~     both term and preterm neonates. In the first study of its kind for prematurity, investigators~     will use sparse and multi-task learning to determine which of the biomarkers of prematurity~     at birth are the best predictors of long-term outcome. Once implemented, these methods will~     be available to compare subcortical structures for other pathologies in newborns and~     children.~   "
11919|NCT03410797|"~     Current semi-occluded vocal tract therapies limit the type of vocalizations that can be~     produced to single vowels, which does not promote learning of the healthy voice behavior in~     connected speech or generalization to conversation. However, recent preliminary results using~     a semi-occluded mask indicate that the use of certain mask port diameters may allow for~     natural speech production while increasing supraglottal pressure and impedance, and thereby~     result in elicitation of voice with increased efficiency. In addition, the use of a~     semi-occluded mask provides the possibility for a better transition from phonating single~     phonemes in therapy to training the target therapy techniques in connected speech.~   "
11920|NCT03410784|"~     This study is designed to assess the therapeutic efficacy and toxicity of the combination~     chemotherapy Paclitaxel and Carboplatin with Pembrolizumab in patients with advanced ovarian~     cancer. The main objective is to test whether the therapeutic intervention benefits the~     patient evaluating the number of subjects who are progression-free after 18 months from the~     beginning of the first line treatment.~   "
11921|NCT03410771|"~     Bioelectrical impedance analysis is studied as a bedside tool to estimate capillary leak in~     order to guide dosing of hydrophilic antimicrobials.~   "
11927|NCT03410693|"~     This is a randomized, open-label, multicenter Phase 2/3 study to evaluate the efficacy and~     safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFRpositive~     locally advanced or metastatic urothelial carcinoma who have received Prior~     platinum-containing chemotherapy.~      The primary objective of the entire study is to compare rogaratinib (BAY1163877) with~     chemotherapy (docetaxel, paclitaxel or vinflunine) in terms of prolonging the Overall~     survival (OS) of patients with FGFR positive urothelial carcinoma.~      At randomization, patients will have locally advanced or metastatic urothelial carcinoma and~     have received at least one prior platinum-containing chemotherapy regimen. Only patients with~     FGFR1 or 3 positive tumors can be randomized into the study. Archival tumor tissue is~     adequate for testing of FGFR1 and 3 mRNA expressions, which will be determined centrally~     using an RNA in situ hybridization (RNA-ISH) test. Approximately 42 % of UC patients with~     locally advanced or metastatic UC are identified as FGFR-positive by the RNA-ISH cut-off~     applied.~   "
11928|NCT03410680|"~     In general, several studies show that adherence to antiretroviral therapy (ART) among men who~     have sex with men (MSM) is low. Yet, high adherence to ART is essential—not only to improve~     the quality of life and survival rates among MSM living with HIV, but also to reduce HIV~     transmission among their partners. Our project aims to address this unmet need through a~     community-based habit-formation intervention, which incorporates elements of gamification.~     This intervention will provide MSM living with HIV who have been recently diagnosed and~     linked to care several tools to develop the habit of taking their medication and overcome~     disruptive adherence events (DAE) that would otherwise lead to treatment abandonment or lower~     adherence.~      Between 2015 and 2017, the investigators conducted a study funded by CONACYT —the Mexican~     Council for Research—in two Mexican cities to involve MSM living with HIV in the design of an~     intervention to improve ART adherence. Results from this study show that at the beginning of~     ART, MSM living with HIV can benefit greatly from a habit-formation community-based~     intervention that includes support mechanisms to tackle the multiple barriers they face.~      Using these findings, the investigators created FUERTES, an intervention with two main~     components: 1) the provision of a simple tool that MSM can access to learn how to develop an~     habit of taking their ART drugs, and 2) the support of a trained peer with background in~     psychology to help teach them how to overcome the myriad of barriers they may face in~     achieving medication adherence.~      This is a multicentre, parallel, randomized, controlled trial. The project's aim is to~     pilot-test the intervention and document its implementation. Specifically, the investigators~     will assess the effect of the intervention on ART adherence among MSM living with HIV at four~     and ten months. Secondary outcomes include viral load and CD4 cell counts. They will also~     assess the scalability of the intervention by measuring the costs of the intervention. The~     duration of the project is two years starting December 2017. The researchers hypothesize that~     the FUERTES intervention will improve ART adherence among MSM living with HIV starting ART by~     at least 15%, measured by the medication possession ratio.~   "
11929|NCT03410667|"~     This study aims to develop an innovative, interactive tool for joint use by spina bifida~     patients and their urologists to identify patients interested in addressing their urinary and~     fecal incontinence and establish continence goal(s) they would like to achieve. To date, no~     such tool exists for use by spina bifida patients or urologists. This represents a major~     paradigm shift in the urologic care of pediatric SB patients. It will give children and~     families a voice in setting their personal goals for urinary and fecal incontinence, rather~     than relying on physicians' traditional clinical targets (e.g., absence of urinary~     incontinence, 4-hour dry interval). These traditional views fail to reflect the full patient~     experience of their ailment by underestimating symptoms and prioritizing only the most~     severe. This study represents the first time that such a process will be formalized before~     initiating urological therapy in children with SB (Aim 2). Additionally, this tool may help~     rule out interventions with a low chance of achieving desired goals and allow for a~     recalibration of unrealistic goals. MyGoal will be useful for any child, regardless of~     urinary and fecal incontinence treatment history or underlying bladder pathology, as it will~     help describe personalized clinical treatment goals based on urinary incontinence, a~     characteristic all these patients share. This study will also capture the health-related~     quality of life (HRQOL) impact of urinary and fecal incontinence improvement regardless of~     the treatment, whether behavioral, medical or surgical, many of which are available to~     patients regardless of age. A systematic therapeutic goal-setting tool will help in bringing~     precision medicine to the SB population.~   "
11930|NCT03410654|"~     The purpose of this study is to determine if cognitive function improves in patients~     converted from tacrolimus immediate release (TAC IR) to Envarsus XR® (tacrolimus extended~     release) using an objective measure of cognition.~   "
11931|NCT03410641|"~     This study examines the effect of a five-year multifactorial lifestyle intervention in the~     Oslo diet and antismoking study on long-term cancer risk. In 1972-1973, 1232 men with high~     cardiovascular risk profile were randomised to intervention including cholesterol lowering~     diet, weight loss and antismoking advice, or control (1:1). This study examines the effect of~     the intervention on 43-year cancer incidence and mortality.~   "
11932|NCT03410628|"~     The purpose of this feasibility study is to gather preliminary information on the safety and~     effectiveness of patient self-administration of a noninvasive neurostimulation of the vagus~     nerve using the GammaCore device for the treatment of pain and allodynia symptoms associated~     with acute migraine in adults.~   "
11933|NCT03410615|"~     Sometimes, cancer patients receive an initial treatment, followed by additional treatment to~     lower the chance of cancer coming back. The standard or usual treatment for this type of~     disease is initially having radiation therapy at the same time as chemotherapy (with a drug~     called cisplatin), with no additional therapy afterwards~   "
11934|NCT03410602|"~     The aim of this study was to evaluate the effect of nonsurgical periodontal therapy on first~     molars banded for fixed orthodontic treatment.~   "
11935|NCT03410589|"~     The purpose of this study is to evaluate quality of life, sleep and fadigue in patients with~     chronic pain using an Item-Response Theory methodology and also generating a Computer~     Adaptive Testing System~   "
11936|NCT03410576|"~     The aim was the comparison of the perioperative time courses of matrix metalloproteinase-9~     (MMP-9) and its inhibitor (TIMP-1) during elective carotid artery stenting (CAS). The~     investigators used a matched, historical carotid endarteriectomy group as controls. Blood~     samples at four time points: T1: preoperative; T2: 60 minutes after stent insertion; T3:~     first postoperative morning; and T4: third postoperative morning. Plasma was isolated from~     heparin anticoagulated blood samples by low speed centrifugation at 4 °C, and stored at -80~     °C until analyzed in a single batch at the end of the study. Plasma concentrations of MMP-9~     and TIMP-1 were expressed as ng/ml.~   "
11937|NCT03410563|"~     The study investigates the analgesic effect of different auditory inputs. Employing a~     within-subject design, the study includes healthy participants that are exposed to thermal~     stimuli while listening to three different auditory inputs. By repeating this on separate~     test days, the involvement of bodily processes is investigated.~   "
11938|NCT03410550|"~     The purpose of the current study is to investigate the effects of powered exoskeleton (EKSO)~     on cardiovascular performance as measured by resting blood pressure and heart rate, peak~     oxygen consumption during walking, energy expenditure, whole and regional body composition~     assessments. The effects of exoskeleton training on walking kinematics including stand-up~     time, walking time, distance covered and speed of walking will also be evaluated.~   "
11939|NCT03410537|"~     Diabetes has become important risk factors for threatening human life and health. Lower~     extremity arterial occlusive are the common complications of diabetes.Sulfur amino acid is~     the indispensable amino acid in mammals, and its metabolites include Taurine, Hydrogen~     sulfide (H2S) and sulfur dioxide (SO2). Taurine was first isolated more than 150 years ago~     from ox (Taurus) bile. Although the taurine can be synthesized in vivo by cysteine in the~     presence of cysteine dioxygenase, it is mainly acquired from dietary sources, such as eggs,~     meat, and seafood. H2S is a biologically relevant mediator and plays potential roles in~     several physiological processes and disease states in the body. H2S is synthesized from 2~     sulfur-containing amino acids, l-cysteine andl-methionine, by the 3~     enzymes,cystathionine-γ-lyase (CSE), cystathionine-β-synthetase(CBS), and3-mercaptopyruvate~     sulfurtransferase (3-MST). Previous studies have demonstrated that Taurine and H2S may play~     important roles in the development of the microangiopathy and lower extremity arterial~     occlusive.~   "
11940|NCT03410524|"~     An adequate bowel preparation has been well established to lead to a successful colonoscopy.~     Research has consistently demonstrated inadequate bowel preparation with lower adenoma~     detection rates. Over the years, endoscopy centers have changed the constituents of bowel~     preparation in light of new research. In 2006, 3 medical organizations recommended the use of~     polyethylene glycol (PEG) solution for bowel preparation. Initially, a 4 liter PEG solution~     was commonly used using a split dose regimen for bowel prep. However, many patients found~     that this large volume gave them side effects including bloating and cramping. Other studies~     showed that a low volume PEG solution with oral bisacodyl fared equally in terms of adequacy~     of bowel preparation. With the institution of lower volume PEG preparation our offices noted~     improved patient toleration, satisfaction, and clinical outcomes. However, multiple~     endoscopists have noticed an increased in intraluminal bubbles and foam with the low volume~     preparation. This can impair proper visualization of the bowel wall even with an adequate~     bowel preparation. The current standard of practice includes irrigation, lavage, and~     suctioning using a simethicone infused saline during the colonoscopy. Its property of~     reducing surface tension to help dissolve bubbles and clear the field of view is vital during~     the procedure. Furthermore, it does not dissolve into the blood stream and thereby, is~     considered rather safe.~      This study evaluates whether the addition of oral simethicone with the colonoscopy bowel~     preparation reduces bubbles and foam during the procedure using a randomized and controlled~     interventional study.~   "
11941|NCT03410511|"~     Propylene glycol/Glycerol intake is increasingly popular. The propylene glycol/glycerol~     intake effects on cardiorespiratory function are unknown.~   "
11942|NCT03410498|"~     The aim of this study is to measure the difference in the walking performance when functional~     electrical stimulation (FES) is on and off in people with MS that present foot drop under~     different 'real life' conditions, i.e. walking while doing another task that requires your~     attention and after been physically tired~   "
11943|NCT03410485|"~     So far, only vital signs (mostly, blood pressure and heart rate) helped the anesthesiologist~     to administer hypnotic agents or analgesics. Many devices have offered pain monitoring for~     anesthetized patients, the most recent being the PMD200 device and its NoL index. The BIS~     index is widely used for depth of anesthesia monitoring. The hypothesis of this study is that~     the intraoperative combination of both the NoL and the BIS indices to guide the delivery of~     opioids and hypotonics respectively, will improve the quality of recovery as well as the~     safety after anesthesia in ERAS patients undergoing colonic surgery.~   "
11944|NCT03410472|"~     Over nutrition has led to an increasing overweight and obese population. Maintaining a~     calorie deficit can be difficult causing many patients to be unsuccessful at weight loss~     attempts.~      There are many smart phone applications that are labeled as weight loss aids, MyFitnessPal™~     being one of these applications. MyFitnessPal ™ assists users to help record calorie intake~     to maintain a balanced caloric intake and to avoid over nutrition~      Primary Hypothesis: This study is testing the hypothesis that subjects using a smart phone~     calorie calculator with intervention will have a greater body fat percentage loss in 8 weeks~     when compared to the control group.~      Secondary Hypothesis: Subjects using a smart phone calorie calculator with intervention will~     report improved self-body image in 8 weeks.~   "
11945|NCT03410459|"~     The goal of this trial is to examine long-term effects of laparoscopic gastric bypass (LRYGB)~     and sleeve gastrectomy (LSG) on bone mineral density, fracture risk, and body composition ≥ 5~     years post-surgery.~   "
11946|NCT03410446|"~     This is a phase 2 study of the drug ketamine for the treatment of depression in cancer~     patients receiving palliative care. The purpose of this study is to see how useful the drug~     is at decreasing the severity of depression these patients. Ketamine will be given through~     the nose.~   "
11947|NCT03410433|"~     Background: Many factors play a role when selecting an appropriate suture for optimal soft~     tissue healing in oral surgery. Moreover, the oral cavity has its specific challenges: it is~     an aqueous environment in which biofilm formation takes place on all surfaces. Therefore,~     oral surgery has specific demands for suture materials.~      Aim: The primary objective of this study was to compare the bacterial load on different~     suture materials. The secondary objective was to determine the impact of suture material on~     decubitus.~      Material & methods: This prospective experimental study with a 'split-mouth' design enrolled~     36 patients requiring oral surgery. Five different suture materials were compared regarding~     their microbiological load and decubitus at the suture removal. Bacterial accumulation on the~     same 5 suture materials was also tested in an in vitro biofilm model.~   "
11948|NCT03410420|"~     This is a prospective study designed to determine the safety and value of Hypoxyprobe-1~     (pimonidazole hydrochloride (-HCl)) to detect levels of tissue hypoxia in patients presenting~     with ascending aortic aneurysm.~   "
11949|NCT03410407|"~     The present study aims at evaluating the prognostic factors at diagnosis predicting Central~     Nervous System (CNS) relapse in order to identify a group of patients with higher risk of CNS~     involvement in which prophylaxis with liposomal Ara-C or other drugs should be indicated.~   "
11951|NCT03410381|"~     Suicide is a major health problem that causes annually a million death worldwide. Suicide and~     suicide attempts are preventable.~      A history of self-injuries or suicidal attempts are known to be the most important risk~     factor for death by suicide. Suicidal ideation is also strongly correlated with suicide~     attempts.~      The development of Smartphones applications offers new possibilities for data collection and~     transmission.~      Moreover, the online help function, when a suicidal crisis occurs, is the most effective~     strategy for prevention of suicidal behavior.~      Specific technologies have been developed to analyse behaviors and experiences of patients in~     a natural environment, in real life.~      That is the goal of Ecological Momentary Assessment.~      The aim of the study is to develop an algorithm to assess and predict the risk of suicidal~     event occurrence, in order to detect as soon as possible the signs of suicidal crisis.~      EMMA will be the first application in French, meeting the recommendations for health~     applications, developed by experts on suicidal behavior and in collaboration with patients~     which aims to predict suicidal risk.~      A subsequent study, conducted on a larger population, should allow to validate the predictive~     algorithm of EMMA.~      Long-term goal is to improve the care of patients at risk for suicidal behavior.~   "
11952|NCT03410368|"~     Natural killer (NK) cells can kill a broad array of tumor cells in a non-major~     histocompatibility complex(MHC)-restricted manner. Adoptive transfer of NK may prolong the~     survival of patients with cancer. This study evaluates the efficacy and safety of NK~     cell-based immunotherapy for small-cell lung cancer (SCLC) after first-line chemotherapy.~     Half of the participants will receive autologous adoptive transfer of NK cells after the~     response from first-line chemotherapy, while the other half will be followed up in routine~     clinal practice.~   "
11953|NCT03410355|"~     The purpose of this study is to evaluate the effect of combined Bone marrow aspirate~     concentrate (BMAC) and Platelet Rich Plasma (PRP) action after a single hip intraarticular~     injection to young symptomatic patients with primary radiologic stage of hip OA~     (Kellgren-Lawrence grade I or II) compared to a control local anesthetic with cortisone~     injection group of patients. The hypothesis is that the patients with hip OA will benefit~     more and for longer from OA symptoms in the BMAC and PRP group rather than in the group of~     local anaesthetic and cortisone. Furthermore, this study could be valuable in determining the~     safety and effectiveness of the BMAC and PRP combined injection for early low grade hip OA in~     young active patients who are neither good candidates for total hip replacement nor~     preservative hip surgery.~   "
11954|NCT03410342|"~     The CIRCUS study is a randomised controlled, cross-over trial to evaluate the effects of~     increased intakes of citrus fruits and cruciferous vegetables on vascular function in 20~     untreated, prehypertensive participants. The study comprises three 14-day dietary~     intervention periods, preceded by one week run-in period and separated by one week wash-out~     periods, 9 weeks in total. The diet will be fully controlled and provided by the researchers.~     Participants will receive in random order three interventions:~        -  1 portion of fruits plus 1 portion of vegetables, of commonly consumed types per day.~          Intakes are at 25th percentile of UK consumption and will exclude citrus fruits,~          cruciferous and allium vegetables.~        -  4 portions of fruits plus 4 portions of vegetables, of commonly consumed types per day~          excluding citrus fruits, cruciferous and allium vegetables.~        -  4 portions of citrus fruits plus 4 portions of cruciferous vegetables per day.~   "
11955|NCT03410329|"~     The aim of this study was to evaluate the effects of a resistance training programme of one~     or three times a week on body composition, cardiometabolic risk factors and handgrip strength~     in overweight and obese women~   "
11956|NCT03410316|"~     The Netherlands Epidemiology of Obesity (NEO) study is a population-based cohort study in~     6671 men and women aged 45 to 65 years, with an oversampling of individuals with a BMI of 27~     kg/m2 or higher. The NEO study is designed to investigate pathways that lead to common~     diseases and conditions.~      Men and women aged between 45 and 65 years with a self-reported BMI of 27 kg/m2 or higher~     living in the greater area of Leiden, the Netherlands, were eligible to participate in the~     NEO study. Participants were recruited via three recruitment strategies. First, participants~     were recruited by general practitioners in the area of Leiden, in the West of The~     Netherlands. Second, participants were recruited through advertisements in local newspapers~     and through posters distributed in public areas of Leiden and surroundings. Third,~     participants were recruited via the registries of three municipalities surrounding Leiden~     (Katwijk, Leiderdorp and Teylingen). Inhabitants of Katwijk and Teylingen aged between 45 and~     65 years were invited to participate if they had a self-reported BMI of 27 kg/m2 or higher.~     All inhabitants aged between 45 and 65 years of Leiderdorp were invited to participate~     irrespective of their BMI, allowing for a reference distribution of BMI.~      Participants were invited to a baseline visit at NEO study centre of the LUMC after an~     overnight fast. Prior to this study visit, participants collected their urine over 24 h and~     completed a general questionnaire at home to report demographic, lifestyle and clinical~     information. The participants were asked to bring all medication they were using to the study~     visit. At the baseline visit an extensive physical examination was performed, including~     measurements of anthropometry, blood pressure, both fasting and postprandial blood sampling~     (30 minutes and 2.5 hours after a liquid mixed meal), ECG, carotid artery IMT, and pulmonary~     function tests. In random subsets of participants MRI of abdominal fat, brain, knee, heart~     function, and pulse wave velocity of the aorta was performed, as well as indirect~     calorimetry, accelerometry combined with continuous heart rate, and total sleep time with~     actigraphy. Participants are followed via their general practitioners and hospital registries~     for the incidence of common diseases and mortality.~   "
11957|NCT03410303|"~     This study is conducted in order to determinate the faisability of an intraoperative~     ultrasound to mesure the positioning of prostheses during laparoscopic promontofixation.~   "
11958|NCT03410290|"~     This study seeks to understand the journey that patients eventually are diagnosed with~     vasculitis experience in the period prior to their formal diagnosis by a healthcare provider.~     Data elements of interest include average time from the onset of the first symptoms to the~     time a diagnosis of vasculitis is confirmed. Other aims include identifying factors~     associated with the time to diagnosis. These factors will be divided into: a) intrinsic~     factors, or so-called patient-related factors, such as the type of vasculitis symptoms,~     patient demographics, socioeconomic status, patients' beliefs regarding the etiology of their~     symptoms, and other factors, and b) extrinsic factors, or professional/health system~     factors, such as healthcare access, referral patterns, testing patterns, and other factors.~     Understanding such factors can guide future efforts to shorten delays in diagnosis and~     thereby improve outcomes. All analyses will be done for the population of patients with~     vasculitis as a whole and by individual types of vasculitis.~   "
11959|NCT03410277|"~     This study will explore the cerebral mechanisms of impaired awareness of hypoglycemia (IAH)~     in type 1 diabetics following exposure to experimental recurrent hypoglycemia (HG). To induce~     IAH, patients with T1D identified to have normal awareness of hypoglycemia (NAH) will undergo~     three 2-hour long hypoglycemic clamps. Neurochemical profiles will be measured by high field~     MRS before and after induction of IAH. Subject glycemic variability for 2 weeks and~     activity/sleep for 1 week before each study will be monitored as all factors have been shown~     to alter responses to HG.~   "
11960|NCT03410264|"~     Despite the efficacy of exposure and response prevention (ERP) for anxiety and phobias,~     recent theoretical research on fear extinction via inhibitory learning suggests that~     cognitive restructuring (CR)--the explicit challenging of maladaptive beliefs (e.g,.~     overestimation of threat)--may actually attenuate exposure outcomes during an exposure trial.~     That is, by verbally disputing certain beliefs (e.g., the spider will jump on me and attack~     me and I will faint from the anxiety) before an exposure task (e.g., gradually approaching a~     non-venomous spider), anxious individuals may experience less surprise from the~     non-occurrence of feared outcomes, and consequently experience less inhibitory learning~     (e.g., learning that spiders are not inherently dangerous). Thus, the investigators aim to~     empirically test the conventional (yet recently challenged) assumption that cognitive~     restructuring is a necessary component for psychosocial interventions for phobias.~      90 participants recruited from the Psychology Department Participant Pool and the community~     will participate in this study. All participants will meet DSM-5 criteria for spider phobia.~     Following consent, participants will complete a pre-test assessment of various aspects of~     spider phobia. Participants will then receive education about the nature of anxiety/spider~     phobia and be randomly assigned to one of three 45-min intervention conditions: (a) CR before~     EXP, (b) EXP before CR, and (c) stress management (a control condition that involves neither~     CR nor EXP). Following the intervention, participants will complete a 10-minute post-test~     assessment and be scheduled to return for a follow-up assessment a month later.~   "
11961|NCT03410251|"~     Twenty-nine patients needing single tooth replacement in aesthetic area were treated by~     extraction and socket preservation with saddle connective tissue graft between September 2009~     and February 2012. Computed Tomography scan were taken at baseline just after the surgery and~     3 months later. Long- term evaluation of this particular socket management procedure was~     evaluated by recalling successfully seventeen of theses patients in June 2016. At this time,~     a clinical and radiographical consultation was done and Cone Beam CT was taken. Horizontal~     and vertical bone dimensional changes were then assessed thanks to 3D imaging analysis and~     esthetic and implants outcomes were evaluated.~   "
11962|NCT03410238|"~     The SafERteens Study demonstrated the efficacy of a brief intervention (BI) for violence on~     changing attitudes, self-efficacy, and reducing violent behaviors, peer victimization, and~     violence-related consequences among adolescents in the emergency department (ED). Using a~     RE-AIM framework to measure outcomes (Reach, Effectiveness, Adoption, Implementation, and~     Maintenance), a study was conducted to translate this BI for violence into clinical practice~     in the ED. A SafERteens Implementation Package was created, which is housed on a website~     (www.saferteens.org), and includes: 1) a self-administered screen via iPad; 2) training~     materials (e.g., standardized patient videos); 3) clinician tools to guide intervention~     delivery; and 4) a tailored text message booster program.~      To increase reach and impact on reducing youth violence, this project will implement~     SafERteens into primary care. Primary care represents a logical dissemination channel for the~     SafERteens intervention because 95% of adolescents report having a usual place for primary~     health care, with 75% receiving medical care in the past six months. Violence interventions~     have yet to be systematically implemented in primary care settings despite the alarming~     prevalence of violent behaviors among adolescents.~   "
11963|NCT03410225|"~     The present study aims to test and rigorously evaluate the effectiveness of a~     computer-assisted motivational interviewing (CAMI) intervention that has already been shown~     to be successful with young women by reducing the risk of rapid subsequent birth among~     adolescent mothers, and applying this intervention to young men.~      The purpose of the intervention is to increase condom use, increase female partner use of~     moderately or highly effective contraception, and increase completion of a reproductive~     health visit and STI/HIV testing.~      The primary hypothesis is that the CAMI-TPP (CAMI aimed at Teen Pregnancy Prevention)~     intervention will increase the proportion of participants who do not engage in risky sex,~     report condom use at last intercourse as well as partner use of contraception compared to~     those in the Fitness group. It is also predicted that young men who receive the CAMI-TPP will~     report higher completion of a reproductive health service visit with sexually transmitted~     infection (STI) testing over the course of study participation compared to those in the~     CAMI-Fitness (CAMI aimed at healthy diet, physical activity and tobacco avoidance) group.~   "
11964|NCT03410212|"~     The aim of this study is to determine whether inferior alveolar nerve block of ketorolac and~     lidocaine would improve the success rate in teeth with symptomatic irreversible Pulpitis.~      Design: In this randomized double-blind clinical trial, sixty healthy adult volunteers with~     including criteria have been randomly divided into two groups (n=30). Following the 5 minutes~     of the first IANB using 1.8 ml 2% lidocaine 2% containing 1:100000, the patients of case~     group have received a standard inferior alveolar nerve block injection that used 1 ml~     ketorolac tromethamine 30 mg/ml. The patients of the control group received a sham injection.~     After achieving the lip numbness, access preparation initiated after 15 minutes of initial~     IANB with two negative responses to the electric pulp test. Any pain during caries and dentin~     removal, access cavity preparation, and root canal preparation have been recorded using~     analog visual scale (HP-VAS). The success was considered as none or mild pain during~     treatment. The data have been analyzed using Mann-U-Whitney test.~      Intervention main outcome measures: Pain during caries and dentin removal access cavity~     preparation, and root canal preparation using VAS.~   "
11965|NCT03410199|"~     Aortocaval compression by the gravid uterus during the third trimester contributes to~     decreased venous return to the heart. Neuraxial anesthesia reinforces this hypotension by~     causing a vasodilatation and venous pooling of blood in the lower limbs. The current practice~     is to tilt the parturient 15 degrees on the operating table after neuraxial anesthesia in~     order to decrease this hypotension. Recent meta-analysis suggests there is no conclusive~     evidence to support the tilt position. The goal of our study is to compare ultrasound vena~     cava variation measurements in the supine versus the tilt position in third trimester~     parturients undergoing elective cesarean delivery.~   "
12099|NCT03408457|"~     This study evaluates antibiotic serum concentrations in correlation with perioperative fluid~     balance. Patients will be recruited in rectum and esophageal surgery (representative for low~     blood loss and restrictive fluid management) and in liver surgery (representative for high~     blood loss and liberal fluid management). The hypothesis is that high blood loss and liberal~     fluid management dilute antibiotic serum concentrations thereby potentially increasing~     surgical site infections.~   "
11966|NCT03410186|"~     Background: Bowel dysfunction is a major complication following open surgery for invasive~     cancer of the bladder that causes significant discomfort, complications and prolongs the~     length of stay in the hospital. Amenable factors that are responsible for postoperative bowel~     dysfunction include intravenous morphine given for pain relief and epidural infusion~     requiring excess intravenous fluids administration after surgery. The British Association of~     Urological Surgeons (BAUS) have published the Enhanced Recovery protocol (ERP) to reduce~     length of hospital stay following open surgery for cancer of the urinary bladder. The ERP is~     a care package that is provided to the patient from the day of the surgery till hospital~     discharge. At Leicester, we have modified the ERP and this has become the standard of care~     for our patients undergoing this surgery. The modified ERP care package includes a novel~     combination of two established pain relief techniques (erector spinae plane analgesia and~     intrathecal opioids) that will avoid the use of epidural analgesia, excess intravenous fluids~     administration and intravenous morphine in the postoperative period. The modified ERP has~     been well accepted by the patients and the clinical team looking after these patients. We~     would like to perform a formal evaluation of the modified ERP care package in the management~     of adult patients undergoing open bladder surgery through an observational pilot study.~      Aim of the study is to evaluate the incidence of postoperative bowel dysfunction and the~     median length of hospital stay in adult patients undergoing(open radical cystectomy Methods:~     Prospective, observational pilot study that will be conducted at Leicester General Hospital~     over 24 months. Adult patients scheduled to undergo open radical cystectomy will be included~     in the study. Patients who will have laparoscopic surgery will be excluded. After providing~     written consent, the participants will receive an enhanced recovery protocol (ERP) care~     package that will commence from the day of their surgery till they are discharged from the~     hospital. Participants will be asked to report time of opening their bowel, pain scores on~     movement, presence of nausea and vomiting, bowel dysfunction, length of hospital stay and any~     complication from day of surgery till 30 days after surgery. Participation in the study will~     end at 30 days after surgery.~   "
11967|NCT03410173|"~     Diabetes has become important risk factors for threatening human life and health. Studies~     have shown that chronic hyperglycemia lead to microvascular brain injury. The more common~     types of dementia are Alzheimer's disease (AD). Cognitive dysfunction is a precursor to~     Alzheimer's disease. Mild cognitive impairment (MCI) is a cognitive impairment between normal~     aging and dementia, mainly manifested as memory impairment, especially episode memory~     defects, but also named obstacles, but the overall cognitive function is normal, daily life~     ability is normal. Studies have shown that middle-aged diabetic patients' cognitive ability~     will decline by about 19% in 20 years compared to people without diabetes.~      Sulfur amino acid is the indispensable amino acid in mammals, and its metabolites include~     Taurine, Hydrogen sulfide (H2S) and sulfur dioxide (SO2). Taurine was first isolated more~     than 150 years ago from ox (Taurus) bile. Although the taurine can be synthesized in vivo by~     cysteine in the presence of cysteine dioxygenase, it is mainly acquired from dietary sources,~     such as eggs, meat, and seafood. H2S is a biologically relevant mediator and plays potential~     roles in several physiological processes and disease states in the body. H2S is synthesized~     from 2 sulfur-containing amino acids, l-cysteine andl-methionine, by the 3~     enzymes,cystathionine-γ-lyase (CSE), cystathionine-β-synthetase(CBS), and3-mercaptopyruvate~     sulfurtransferase (3-MST). Previous studies have demonstrated that Taurine and H2S may play~     important roles in the development of themicroangiopathy and lower extremity arterial~     occlusive.~   "
11968|NCT03410160|"~     Within this clinical study patients with chronic adrenal insufficiency will be investigated~     by clinical and biochemical examination as well as questionnaire to identify predisposing~     factors for adrenal crisis.~   "
11969|NCT03410147|"~     The objective of this dose-finding and feasibility study is to establish the optimal~     13C-octanoate concentration to be used with slowly infused enteral nutrition to perform a~     prolonged gastric emptying test using the breath test. More specifically, the aim is to~     discover the 13C-octanoate concentration that induces a steady state hourly 13C-recovery.~     This would allow to implement the prolonged breath test protocol in a future clinical~     investigation in critically ill patients.~   "
11970|NCT03410134|"~     The purpose of this study is to evaluate the long term clinical performance of vital pulp~     therapy of young permanent teeth with irreversible pulpitis~   "
11971|NCT03410121|"~     The aim of this study is to compare the humeral and thoracic implantation of a central venous~     access by an implantable device in patients with solids tumors who require intravenous~     chemotherapy. This is a monocentric randomized study. 572 patients will be recruited for 2~     years. They will be randomized either in the thoracic implantation, either in the humeral~     implantation Due to the 1:3 randomization, 143 patients will be randomized in the humeral arm~     and 429 into the thoracic one. Number of complications related to the implantable device,~     medico-economic analysis as well as patient satisfaction will be assessed.~      Every patients with solid tumor requiring medical device implantation for intravenous~     chemotherapy treatment will be eligible.~      Both humeral and thoracic implantation of medical device are standard procedures. The~     randomization in a specific arm is the study procedure and is considered as an interventional~     study in France.~   "
11972|NCT03410108|"~     The purpose of this study is to evaluate efficacy and safety of Brigatinib in Japanese~     patients with anaplastic lymphoma kinase (ALK)-positive NSCLC that has progressed after 1 or~     2 lines of prior ALK inhibitor therapy.~   "
11973|NCT03410095|"~     Sleep is critical to human health, but insufficient and disrupted sleep caused by sleep apnea~     are common and have a major impact on brain health. However, there is still much that is not~     known about how sleep apnea damages the brain and what can be done to fix this. The Brain~     Changes in Sleep Apnea Study will look at the brain health of people with severe sleep apnea~     both before and after 4 months of treatment with a CPAP machine. Pre- and post-CPAP~     treatment, 80 participants with severe sleep apnea will undergo cognitive testing, blood and~     urine tests, a pulse wave velocity test, and an MRI. Also pre- and post-CPAP treatment,~     participants will wear a blood pressure monitor for 24 hours, wear an accelerometer watch for~     7 days to track the duration and quality of their sleep, and wear a device for 1 night of~     sleep to assess their breathing and blood oxygen levels. It is expected that there will be~     improvements in participants' brain health after 4 months of CPAP treatment.~   "
11974|NCT03410082|"~     The investigators will evaluate the effect of bispectral index-guided titration of sedation~     during ear surgery under monitored anesthesia care on participant's satisfaction with~     anesthesia, as well as side effects caused by the anesthetics.~   "
12024|NCT03409432|"~     This phase II trial studies how well brentuximab vedotin and lenalidomide work in treating~     patients with stage IB-IVB T-cell lymphoma that have come back or do not respond to~     treatment. Monoclonal antibodies, such as brentuximab vedotin, may interfere with the ability~     of cancer cells to grow and spread. Drugs used in chemotherapy, such as lenalidomide, work in~     different ways to stop the growth of cancer cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Giving brentuximab vedotin and~     lenalidomide may work better in treating patients with T-cell lymphoma.~   "
46123|NCT02963155|"~     Prospective research of Natural Killer cells as predictive biomarkers to stratify patients~     likely to have longer response time to castration.~   "
11975|NCT03410069|"~     Circulatory shock is defined as an imbalance between oxygen supply and/or impaired oxygen use~     to maintain organ function. With growing evidence of lack of correlation between macro- and~     micro-circulation, use of Whole Body markers such as blood pressure (BP) or Lactates are~     often insufficient to assess the severity of the oxygen debt and/or tissue hypoperfusion.~     Thus, an approach incorporating tissue-perfusion based endpoints would represent a~     significant step up to guide optimal resuscitation of critically-ill patients and to reduce~     complications in high-risk surgery.~      Current monitoring techniques, that complement systemic hemodynamics by focusing on regional~     perfusion, still lack the required user-friendliness and/or clinical relevance to be~     routinely used at bedside. Therefore, assessment of the adequacy of tissue perfusion and~     oxygenation is suboptimal, and implementation of the above-mentioned approaches of~     resuscitation is still a challenge.~      Urethral perfusion is likely to be early and significantly impaired during low-flow states~     and thus represents a good candidate as a surrogate site to assess the perfusion of~     visceral organs. Besides, urethral mucosa can be investigated in a less invasive and simpler~     manner than deeper organs. Nowadays, no practical methods or devices are available to~     monitor perfusion in the pelvic area. Thus, recent development of a new monitoring device of~     urethral perfusion could fill this need and enable enhanced management of patients in~     Intensive Care Units (ICU) and Operating Rooms (OR).~      The device consists of a modified Foley catheter equipped with a photoplethysmographic~     sensor: the IKORUS UP probe.~      The probe will be used by intensivists on ICU patients with unstable hemodynamic states~     and/or suspicion of microcirculation impairment. The device is also intended to be used by~     anesthesiologists on high-risk surgical patients, i.e. patients with comorbidities undergoing~     major vascular, thoracic and/or abdominal surgery.~   "
11976|NCT03410056|"~     Phase 1b. To evaluate the safety and tolerability of subcutaneous (SC)dose administrations of~     AMG 592 in subjects with active RA.~      Phase 2a. To evaluate the efficacy of AMG 592 at week 12 as measured by the American College~     of Rheumatology 20% improvement criteria (ACR 20) in adult subjects with moderate to severe~     RA.~   "
11977|NCT03410043|"~     The goal of this research is to learn if receiving local consolidation therapy (LCT--~     surgery, radiation, or a combination of radiation and surgery) after receiving osimertinib~     can help to control non-small cell lung cancer (NSCLC) compared to continued treatment with~     osimertinib alone. The safety of this treatment will also be studied.~      This is an investigational study. Osimertinib is FDA approved and commercially available for~     the treatment of NSCLC. It is considered investigational to give surgery and/or radiation~     after osimertinib to patients with NSCLC.~      Up to 143 participants will be enrolled in this multicenter study. Up to 143 may take part at~     MD Anderson.~   "
11978|NCT03410030|"~     The purpose of this study is to see if a treatment regimen with a combination of paclitaxel~     protein bound (also known as nab-paclitaxel), gemcitabine, and cisplatin when given with high~     dose Ascorbic Acid will be safe and effective in individuals with untreated metastatic~     pancreatic cancer.~   "
11979|NCT03410017|"~     Single center, cross sectional observational research design to collect normative data on the~     acquisition of listening skills in normally-hearing children aged 0-6 years of age.~   "
11980|NCT03410004|"~     Study of Chidamide as a single-agent treatment for patients with relapse or refractory~     Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL)~   "
11981|NCT03409991|"~     This project is designed to develop and test a career guidance intervention called Opening~     Doors (OD) expected to assist individuals with psychiatric disabilities acquire knowledge,~     skills, and attitudes needed to pursue and advance in their careers. This project is a~     three-stage mixed methods study to 1) refine and pilot-test the Opening Doors career guidance~     intervention, 2) conduct a randomized control trial (RCT) to test the efficacy of the~     intervention with a waitlist control group, and 3) conduct a qualitative and process~     sub-study of the critical ingredients of the OD intervention from the perspective of~     participants. This study takes place at the Boston University Center for Psychiatric~     Rehabilitation (CPR). It is hypothesized that when compared to control group participants,~     individuals receiving Opening Doors will report 1) higher levels of vocational and~     pre-vocational activities, 2) greater career adaptability, fewer dysfunctional and more~     functional career thoughts, 3) greater work hope when compared to the waitlist control group~     participants, 4) greater vocational goal attainment, and 5) improved symptoms and~     functioning.~   "
11982|NCT03409978|"~     Analysis of spontaneous movements in young infants from video recordings is recommended as an~     early medical assessment tool for prediction of cerebral palsy in high-risk infants. Such~     video recording have previously been performed in follow-up programs at hospitals using semi~     standardized video set-ups. The research group behind this study develops a smart-phone~     application that makes it possible for parents to video film their infant spontaneous~     movements at home, upload and send the video for analysis at the hospital provided by~     experts. The objectives of the study are to assess the feasibility of the In-Motion app for~     video recording of infant spontaneous movements, upload and send the video to St. Olavs~     Hospital in Trondheim, Norway, for assessment, and how parents experience this. 90-120~     high-risk infants from Norway, Denmark, Belgium, USA, Great Britain and India will~     participate. Parents will record their infant spontaneous movements and answer~     questionnaires. Video quality will be evaluated by experts within the field and their use for~     computer-based assessment will be evaluated.~   "
11983|NCT03409965|"~     This is a prospective, multi-site, non-randomized study evaluating the safety and~     effectiveness of the Infini and LaseMD Systems for combination treatment in wrinkles,~     texture, and pigmentation of the face and/or neck.~   "
11984|NCT03409952|"~     The Lutronic LaseMD Laser System will be evaluated for the treatment of benign pigmented~     lesions.~   "
11985|NCT03409939|"~     Phenylalanine and tyrosine are aromatic amino acids that people need to obtain in their~     diets. Amino acids are the building blocks for protein, are are therefore required to form~     tissues in the body. It is well known that pregnant women require more protein in their~     diets, but the exact amount for each amino acid is undetermined. To find out how much of~     phenylalanine and tyrosine pregnant women require, the investigators plan to study pregnant~     women in early and late gestation with a modern minimally invasive technique.~   "
11986|NCT03409926|"~     FEAST-HF is a single-centre clinical trial in ambulatory patients with chronic HF to evaluate~     whether dietary supplementation with acacia gum reduces HF-related biomarkers NT-proBNP and~     ST2 and how the gut microbiome responds to dietary supplementation with acacia gum. The~     hypotheses of this study are 1) that changes in the gut microbiome will be correlated with a~     reduction in NT-proBNP and ST2 in patients with HF after treatment with acacia gum, and 2)~     gut microbiome configurations (composition, diversity), stability and function (gene content)~     will be significantly altered in patients with HF in response to acacia gum.~   "
11987|NCT03409913|"~     A case-control study to evaluate the diagnostic accuracy of FDG uptake in cranial arteries by~     FDG PET/CT in the diagnosis of giant cell arteritis.~   "
11988|NCT03409900|"~     Total hip arthroplasty (THA) is one of the most successful orthopedic procedures to~     effectively relieve pain and restore function in patients with end stage osteoarthritis. In~     an attempt to accelerate recovery many orthopedic surgeons have opted to utilize a direct~     anterior approach (DAA) as opposed to the more traditional posterolateral approach (PLA). The~     literature supports that DAA is superior to PLA with regard to lower blood loss, less pain,~     shorter hospital stay, and faster rehabilitation. Traditionally the study team has performed~     Lumbar Plexus blocks (LPB) to provide post-operative analgesia for total hip arthroplasty.~     The quadratus lumborum block (QLB) is a newer regional analgesic technique that may be as~     effective as LPB at providing pain control following DAA hip arthroplasty. This study is~     designed to compare the efficacy, with regards to post-operative pain management, between LPB~     and QLB following a DAA total hip arthroplasty.~   "
11989|NCT03409887|"~     Based on various in-vitro studies intraorifice barrier has been suggested as an effective~     mean to provide seal against coronal microleakage. This study intends to clinically~     investigate efficacy of intraorifice barrier in healing of apical periodontitis.~   "
11990|NCT03409874|"~     The purpose of this research is to compare two different approaches for treating patients~     with temporomandibular dysfunction (TMD): Dry needling and spinal manipulation or~     Interocclusal Appliance (Splint), NSAIDs and Temporomandibular Joint Mobilization .~     Clinicians commonly use all of these techniques to treat TMD. This study is attempting to~     find out if one treatment strategy is more effective than the other.~   "
11991|NCT03409861|"~     A wristband device intended for use as a standalone device, designed for the measurement of~     intermittent blood pressure, as well as other physiological signals. The device is intended~     to be worn in day to day life by individuals suffering from hypertension or other conditions~     where monitoring of blood pressure is of importance.~   "
11992|NCT03409848|"~     The INTEGA study assesses therapy Options for advanced or metastatic esophagogastric~     Adenocarcinoma in patients overexpressing human epidermal receptor type 2 (HER2 positive~     patients). Current treatment options in this situation include chemotherapy based palliative~     treatment in combination withTrastuzumab.~      Recent studies have shown that immunotherapy with Nivolumab or Ipilimumab after previous~     chemotherapy can also improve survival in esophagogastric cancer.~      This study assesses the efficacy of two experimental first line treatment strategies: A)~     Chemo-free immunotherapy with Trastuzumab, Nivolumab and Ipilimumab and B) addition of~     Nivolumab to the standard regimen (FOLFOX chemotherapy and Trastuzumab).~   "
11993|NCT03409835|"~     Nausea and vomiting after general anesthesia is one of the common anesthetic complications.~     If the patient is discharged from the hospital after surgery, proper treatment may be delayed~     or impossible if nausea or vomiting occurs. Thus, It is necessary to prevent these symptoms~     beforehand. Patients who underwent gynecologic surgery will be treated with prophylactic~     ramosetron to determine whether the frequency of nausea and vomiting is decreased when the~     patient returned home after discharge.~   "
11994|NCT03409822|"~     Non-invasive hemoglobin monitoring will be performed in patients who underwent cesarean~     section with placenta previa and this will be compared with actual laboratory findings.~      The investigators will investigate whether noninvasive hemoglobin monitoring can adequately~     reflect the massive bleeding that occurs within a short period of time and find out if it~     matches the actual laboratory findings.~   "
11995|NCT03409809|"~     This project will evaluate 3 approaches of implementation support for university peer leaders~     who will deliver a prevention program with a particularly strong evidence-base compared to~     changes observed in outcomes in response to usual care at the universities before~     implementation. This study aims to advance knowledge of this innovative and economical way to~     provide college prevention programs to reduce the burden of mental illness in the college~     student population.~   "
11996|NCT03409796|"~     The primary purpose of this study is to characterize changes in gluten-specific T cells and~     pathology in the small intestine with specific focus on biomarkers likely to change with~     therapeutic celiac disease (CeD) treatment.~   "
11997|NCT03409783|"~     Enso is a portable device for the treatment of chronic and acute types of musculoskeletal~     pain. This study is being designed as a single blind, sham-controlled randomized clinical~     trial.~   "
11998|NCT03409770|"~     Phase II randomised control trial of whole body cooling in mild neonatal encephalopathy.~   "
11999|NCT03409757|"~     This pilot study will be carried out to determine if the regular intake of iron-based~     Velphoro® by hyperphosphatemia patients influences the microbiome in the oral cavity and/or~     the gut.~   "
12000|NCT03409744|"~     The primary objective of the study is to evaluate the long-term safety and tolerability of~     evinacumab in patients with Homozygous Familial Hypercholesterolemia (HoFH). The secondary~     objectives of the study are to evaluate the effect of evinacumab on lipid parameters in~     patients with HoFH and to evaluate the potential development of anti-evinacumab antibodies.~   "
12001|NCT03409731|"~     The purpose of the Surveillance is to know the frequency and status of adverse device effects~     and adverse events in order to assure the safety of the new medical device, and to collect~     efficacy and safety information for evaluating clinical use results.~   "
12002|NCT03409718|"~     This study is a retrieval of database information regarding survivorship of the Comprehensive~     Shoulder System family of products. The primary objective of the retrieval is to collect data~     that will contribute to the post market surveillance requirements for this product and will~     provide feedback to design engineers, support marketing efforts and publications, and answer~     potential questions form reimbursement agencies.~   "
12003|NCT03409705|"~     Comparison of a randomized, double-blind, and control-group study for the effect of oral~     ingestion of low-molecular collagen peptides derived from Skate Skin on body fat reduction in~     adults~   "
12036|NCT03409276|"~     The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of env~     (A,B,C,A/E)/gag (C) DNA and gp120 (A,B,C,A/E) protein/GLA-SE HIV-1 vaccines (PDPHV-201401) as~     a prime-boost regimen or co-administered in repeated doses, in healthy, HIV-1-uninfected~     adults.~   "
12037|NCT03409263|"~     Patients with TIPS will be recruited in this prospective registry study. The clinical course~     will be documented and biomarkers for prediction of complicatiosn will be assessed.~   "
12004|NCT03409692|"~     The consortium aims to commercialise the MMpredictor as a personalised medicine tool that~     predicts the most effective treatment strategy for individual Multiple Myeloma (MM) patients.~     MM is the second most common form of blood cancer contributing to 15% of all blood cancers~     and ~1,5% and 2% of all cancer deaths annually in the EU and US, respectively.~      Patients show a large variability in treatment response and side effects due to tumour~     heterogeneity and the patient's intrinsic characteristics. Therefore, not every treatment~     will be suitable for each patient, and treatment strategies are often based on~     trial-and-error. The availability of multiple (>20) treatment options complicates treatment~     decision-making even more. With the current development of many more promising treatments,~     there is an urgent unmet clinical need for a diagnostic assay that supports personalised~     cancer treatment in order to improve patient health outcomes, prevent side effects and reduce~     healthcare costs.~      SkylineDx has previously developed the MMprofiler, a microarray-based diagnostic test that~     can subtype MM patients and reliably predict MM patient survival (prognosis). In this~     project, the test's clinical value will be expanded to include the prediction of treatment~     effectiveness in individual patients based on Gene Expression Profiling. An addendum for new~     intended use will be filed to the current in vitro diagnostic (IVD) registration, while~     renaming the test to MMpredictor. The project will also focus on positioning the test as a~     cost-effective IVD test for personalised medicine, that will increase health outcome and~     quality of life of patients and reduce healthcare costs.~      The consortium consists of a life science SME specialised in molecular diagnostics, clinical~     centres with world renowned KOLs, a leading health economic institute, and a European MM~     patient advocacy organisation combining all the required complementary expertise to~     successfully bring the MMpredictor to market.~   "
12005|NCT03409679|"~     This is a phase 3, multicenter, open-label, randomized active-controlled, parallel group to~     investigate the efficacy, safety and tolerability, and pharmacokinetics of intravenous~     murepavadin combined with of one anti-pseudononas antibiotic with that of two~     anti-pseudomonas antibiotics in the treatment of ventilator-associated bacterial pneumonia~     (VABP) in adult subjects.~   "
12006|NCT03409666|"~     This is a single center, prospective, randomized controlled study. The primary objective of~     this study is to measure migration over two years with RSA. Patients will be randomized in~     two arms, receiving a Taperloc Complete Reduced Distal or a Taperloc Complete Microplasty hip~     stem.~   "
12007|NCT03409653|"~     The purpose of this data registry is to prospectively collect data from patients referred to~     an Complex Chronic Diseases Program (CCDP) at BC Women's Hospital + Health Centre to assess~     the quality of life of the CCDP Patients before, during and after their care at the CCDP.~   "
12008|NCT03409640|"~     This study is being conducted to determine the rate of symptomatic and asymptomatic~     nonmalignant, noninfective soft tissue mass presence (referred to in the literature as~     pseudotumour, ALVAL, ARMD, cysts or lesions) in primary metal on metal hip replacement~     patients. The primary objective of the study is to determine the prevalence of masses in~     unbiased Metal on Metal (MoM) samples drawn from one study centre. The subjects receiving the~     Metal on Metal devices will be observed at two specific time points. Secondary objectives are~     to evaluate whether the occurrence of masses is related to any of several potential factors~     including patient and implant characteristics and time since the implant procedure took~     place.~   "
12009|NCT03409627|"~     To evaluate the safety of retrograde coronary sinus infusion of a novel triple-effector~     plasmid (INXN-4001) in outpatient LVAD recipients as assessed by incidence of all study~     intervention - related adverse events occurring up to 6 months post-treatment~   "
12010|NCT03409614|"~     The primary objective is to compare the progression-free survival (PFS) of REGN2810 plus~     platinum-based doublet chemotherapy combination therapy (REGN2810/chemo) and REGN2810 plus~     platinum-based doublet chemotherapy plus ipilimumab combination therapy (REGN2810/chemo/ipi)~     with standard-of-care platinum-based doublet chemotherapy in the first-line treatment of~     patients with advanced squamous or non-squamous non-small cell lung cancer (NSCLC) in the~     subgroup of patients whose tumors express programmed cell death ligand 1 (PD-L1) in 1% to~     <50% of tumor cells and in the overall population of study patients whose tumors express~     PD-L1 in <50% of tumor cells. The key secondary objectives are to compare the OS of~     REGN2810/chemo and REGN2810/chemo/ipi versus standard-of-care platinum-based doublet~     chemotherapy in the first-line treatment of patients with advanced squamous or non-squamous~     NSCLC in the subgroup of patients whose tumors express PD-L1 in 1% to <50% of tumor cells and~     in the overall population of study patients whose tumors express PD-L1 in <50% of tumor~     cells, to compare the ORR of REGN2810/chemo and REGN2810/chemo/ipi versus standard-of-care~     platinum-based doublet chemotherapy in the first-line treatment of patients with advanced~     squamous or non-squamous NSCLC in the subgroup of patients whose tumors express PD-L1 in 1%~     to <50% of tumor cells and in the overall population of study patients whose tumors express~     PD-L1 in <50% of tumor cells, and to evaluate the safety and tolerability of REGN2810/chemo~     and REGN2810/chemo/ipi compared to standard-of-care platinum-based doublet chemotherapy~   "
12011|NCT03409601|"~     The study uses a crossover design in which the portion size of food is varied at each meal.~     Across four test meals, subjects will be served four different portions of food, and intake~     will be determined from pre- and post-meal food weights. The first visit will be a screening~     visit, at which subjects will complete the consent form, have their height and weight~     measured, and rate the taste of the study food. Test meals will be scheduled once a week for~     four weeks. At visits 2-5, subjects will eat lunch and rate characteristics of the meal. At~     visit 6, subjects will complete various questionnaires. The objective of this study is to~     determine whether any individual characteristics related to satiety influence the effect of~     portion size on intake.~   "
12012|NCT03409588|"~     This is an open label study of Riociguat in patients with continued exercise intolerance at~     least 6 months following pulmonary endarterectomy (PEA).~   "
12013|NCT03409575|"~     The decline in physical function and strength was seen by the nature of aging. The older~     adults often complain of fatigue. For these reasons, proper rehabilitation approaches should~     be used to ensure healthy life and to keep the quality of life at the highest possible level~     by minimizing the decline seen with aging process. Exercise programs and Neuromuscular~     Electrical Stimulation (NMES) are applied in rehabilitation to restore muscular strength and~     improve physical performance. NMES is used to prevent the atrophy of nonuse, to increase~     joint range of motion, to re-educate muscle, to regulate spasticity, to replace orthosis, to~     improve motor involvement of muscle fibers. Despite the use of NMES for strengthening in the~     clinics, the application parameters and methods should be discussed. The frequency, the pulse~     duration, the on / off time, the amplitude, the waveform of the current and the application~     time vary between the studies. For geriatric populations, it is recommended that the highest~     intensity, biphasic symmetrical currents with a frequency in the range of 50-100 Hz, for~     100-400 μs, can be pulsed for ideal amplification. NMES is usually practiced by~     physiotherapists continuously for 20 minutes in to strengthen. However, in recent studies, it~     has been shown that continuous application of a single-session 100 Hz current for 20 minutes~     leads to intense fatigue and after a while the effect of the strengthening of the current has~     been removed. Therefore, intermittent applications have been proposed instead of continuous~     applications for 20 minutes. Considering the fragility and the presence of sarcopenia in the~     geriatric population, NMES applications should be preferred in which rest periods are given~     instead of continuous application for 20 minutes. In the literature, there is no study~     showing the effect of NMES on Quadriceps strength, fatigue and physical function by using~     quadriceps stimulation for 20 minutes using different stimulation periods.Therefore, in this~     study, will be investigated the possible effects of two different methods of NMES on~     Quadriceps strength, fatigue and physical function.~   "
12015|NCT03409549|"~     Glioblastoma is the most common adult brain tumour with approximately 2000 new cases each~     year in the UK.~      Optimal treatment consists of surgery followed by radiotherapy and chemotherapy but despite~     this survival is poor with only 10% of patients alive at 5 years.~      Standard imaging (MRI and CT) may not detect the full extent of tumours before treatment and~     it can be difficult to assess how the tumour is responding to treatment.~      The study aims to evaluate more advanced imaging techniques to see if they are better at~     mapping the whole tumour and assessing response to treatment. Two different imaging~     techniques will be assessed: Positron Emission Tomography - Computed Tomography (PET-CT) uses~     a mildly radioactive compound injected into the patient which is taken up into brain tumour~     cells and shows up as a bright spot on scans. Brain tumours affect blood supply and how much~     fluid is in the brain tissue as well as how freely fluid can move around. Advanced MR imaging~     known as multiparametric MRI will be used to look at these additional features. This extra~     information may help improve planning of radiotherapy and assessing how tumours respond to~     treatment. Twelve adult patients with glioblastoma undergoing radical treatment will be~     recruited over a 12 month period. Each patient will have standard MR imaging before~     radiotherapy (after surgery) and 4-6 weeks following completion of radiotherapy. They will~     also have advanced MRI and PET/CT before, during and after treatment.~      The aim will be to study if this is feasible and could potentially improve radiotherapy~     planning and response assessment. Imaging will be interpreted by both imaging and brain~     tumour treatment experts.~   "
12016|NCT03409536|"~     Brachial plexus block is a common regional anesthesia technique which is performed by~     anesthesiologists to anesthetize the arm for surgery. In this study, we are investigating the~     relationship between the nerve conduction (induced by brachial plexus block) and the~     patients' symptoms before and after the brachial plexus block. We will attach a nerve~     conduction device (SSEP device) to monitor the patients' arm conduction and we will assess~     the patients' symptoms simultaneously.~   "
12017|NCT03409523|"~     This study will develop a new electronic health record module to improve guideline-compliant~     care of older adults with diabetes. The module will incorporate effective behavioral~     economics (BE) principles to improve the degree to which care of older adults is compliant~     with Choosing Wisely guidelines; this generally involves less aggressive targets for HbA1c,~     and reductions of medications other than metformin.~      The implementation of the module will ultimately be triggered by medication prescribing in~     EPIC. The BE principles include suggesting alternatives to medications, requiring~     justification, setting of appropriate default order sets, and incorporation of anchoring and~     checklists to guide behavior. The study will involve provider workflow analysis based on~     observation, module user testing, and live usability testing with direct observation and~     semi-structure interviews.~   "
12018|NCT03409510|"~     Skin pigmentation (melanin) absorbs ultra violet type B (UVB) radiation found in sunlight and~     is believed to be responsible for darker-skinned persons' generally low 25(OH)D status. This~     phenomenon is found in immigrants living in Northern countries and their 25(OH)D responses to~     UVB-irradiation seem low.~      We hypothesized that objectively measured skin pigmentation and/or pigment genes influence~     UVB-induced 25(OH)D increase significantly in combination with other influential parameters.~      The influence of objectively measured constitutive and facultative skin pigmentation on~     UVB-induced 25(OH)D increase over time was investigated together with other possible~     influential parameters. These other influential parameters include sex, age, weight, height,~     BMI, number of fatty fish meals per week, Fitzpatrick Skin Type and 25(OH)D start level. The~     genetic parameters include 33 Vitamin D receptor and pigment SNPs.~      This is a single-centre, open and non-blinded clinical trial. No randomisation was used, as~     the participants were allocated into two groups based on their Fitzpatrick Skin type and~     ethnic origin. The light-skinned group included participants with Fitzpatrick Skin type II-IV~     and were of Northern origin (Denmark, the Faroe Islands and the UK). The darker-skinned~     included Fitzpatrick Skin Types V-VI originating from countries located at latitudes below 50~     degrees N. Thus, it could be ensured that the participants represented a wide range of skin~     pigmentation. The light-skinned (N = 22) and the darker-skinned subjects (N = 18) were~     exposed to identical UVB doses on identical body areas over nine weeks with weekly~     measurements of 25(OH)D. The UVB-induced 25(OH)D synthesis was investigated in~     summer-pigmented skin with melanin throughout the epidermis and during winter when ambient~     UVB exposure is negligible. Demographic data (gender, age, weight, height, Fitzpatrick Skin~     Type, measured constitutive and facultative skin pigmentation (PPF)) was collected/measured~     and registered in prior to study start. The number of daily consumed fatty fish meals was~     recorded in a questionnaire. Serum 25(OH)D was analysed weekly.~   "
12019|NCT03409497|"~     Assess the impact of 100% grape juice with a meal on postprandial glycemic response and~     subsequent appetite, food intake and cognitive function.~   "
12020|NCT03409484|"~     Assess the impact of 100% grape juice on postprandial glycemic response and subsequent~     appetite, food intake and cognitive function.~   "
12021|NCT03409471|"~     This study is a prospective observational study of human papillomavirus (HPV) testing using~     urine and self-collected vaginal samples for women who have atypical squamous cells of~     undetermined significance(ASCUS) or low grade squamous intraepithelial lesion(LSIL) on Pap~     test. Among women who are diagnosed with ASCUS and LSIL, HPV test is performed by collecting~     urine and self-collected vaginal sample in standardized condition before colposcopy, and~     evaluation will be performed as a primary screening test with cytology triage.~   "
12022|NCT03409458|"~     This is a Phase 1b/2a, open-label, multi-center, non-randomized, dose-escalation study of~     PT-112 in combination with the anti-PD-L1 antibody, avelumab, in selected advanced solid~     tumors. The study is to be conducted in two parts: the Dose Escalation Phase of PT-112 within~     the combination and the Dose Confirmation Phase. The Dose Escalation Phase will determine the~     Maximum Tolerated Dose (MTD) and recommended Phase 2 dose (RP2D) of PT-112 in the combination~     as avelumab will be administered at a flat dose of 800 mg. The trial will evaluate the PK~     (pharmacokinetic) effects of PT-112 and the safety and tolerability of the combination as~     well as preliminary clinical effects. The Dose Confirmation Phase will consist of two~     additional cohorts in patients with non-small cell lung cancer or urothelial carcinoma who~     will be treated at or below the MTD of PT-112 in the combination.~   "
12023|NCT03409445|"~     As essential nutrients omega 3 fatty acids contribute to normal growth and development.~     Inadequate intake is linked to the development of chronic diseases such as coronary heart~     disease, high blood pressure, cancer, arthritis, psychological illnesses and allergies.~     Therefore, it is important to be able to reliably detect the intake of these fatty acids. Due~     to eating habits varying in different countries the questionnaire documenting dietary habits~     needs to be adapted to the situation in question. Based on a US version the investigators~     developed a questionnaire suitable for Switzerland and now wish to validate it by measuring~     the fatty acid composition of red blood cells, which will provide information on the intake~     of the various fatty acids.~   "
12139|NCT03407924|"~     The purpose of this study is to examine the effects of exercise on recovery after traumatic~     brain injury. Investigators will determine if exercise enhances rehabilitation by increasing~     substances (proteins) that can facilitate recovery.~   "
12025|NCT03409419|"~     The goal of this proposal is to assess the biodistribution of 18F-Clofarabine, a new tracer~     developed for use in PET/CT scans. The investigator's hypothesis is this tracer will allow~     for imaging immune activation in patients with melanoma before and after treatment with~     immunotherapy.~      A maximum of 10 subjects are intended to be included in this study. Each subject will undergo~     a maximum of two 18F-Clofarabine PET/CT scans, with each visit taking up to 4 hours. The~     first visit will be prior to the first cycle of immunotherapy treatment, and the second scan~     will take place 2-4 weeks after the immunotherapy treatment has started.~      Prior to the PET scan an IV line will be placed. Blood pressure, heart rate, blood oxygen and~     ECG will be obtained. Then the 18F-Clofarabine will be injected and the PET/CT scan~     acquisition started. After a maximum of 120 min of scanning, subjects will undergo again~     blood pressure, heart rate, blood oxygen and ECG.~   "
12026|NCT03409406|"~     The goal is to remediate speech and language disorders early in the lives of South African~     children with significant developmental disorders (DD) by enhancing the health care service~     delivery system to better serve families across diverse backgrounds. This study assesses a~     new hybrid intervention to promote better communication skills for both the child and~     caregiver. The hybrid intervention includes a mobile health technology (MHT) web-based tablet~     protocol that assists parents/caregivers in communicating with their children on a daily~     basis at home over a 12-week period in addition to the current standard of care intervention,~     a 30-minute speech-language therapy session at the secondary/tertiary hospitals once a month.~     The hybrid intervention adds to the child's monthly therapy session by providing~     parents/caregivers with instruction about communication with their children via a sequenced~     web-based tablet protocol across a 12 week time period and face-to-face monthly follow-up at~     the hospital where the child receives therapy. Fifty parent/caregiver-child pairs (25 per~     group) will be assigned to either the hybrid intervention or the standard of care~     intervention. Child receptive and expressive language skills, child and parent/caregiver~     communication interactions and parent/caregiver and speech therapist satisfaction with child~     communication will be measured prior to the intervention and then again at the end of the~     12-week period. The effects of the hybrid intervention and standard of care intervention on~     child communication skills, caregiver perception and satisfaction and speech therapist~     perception and satisfaction will be measured. The expectation is that the new MHT enhanced~     hybrid intervention program that is applicable and deliverable in culturally and~     linguistically diverse settings will enhance the child's receptive and expressive~     communication skills and result in greater parent/caregiver and speech therapist satisfaction~     related to the child. The impact includes enhanced health care service delivery to South~     African children with DD and their families so as to better serve the children with DD by~     remediating speech and language disorders on a daily basis.~   "
12027|NCT03409393|"~     The aim of the COPUS study is to investigate, whether it is possible to recruit and retain~     young people with first-episode psychosis, to an 8 week supervised High-Intensity Functional~     Training intervention (HIFT) (i.e. COPUS Intervention) and to investigate if oxygen uptake,~     body composition and physical function improves following participation in the intervention.~   "
12028|NCT03409380|"~     This study will assess effects of an acute dose of the amino acid arginine on metabolism in~     healthy young men.~   "
12029|NCT03409367|"~     Atopic dermatitis (AD) affects over 9 million children in the U.S. and often heralds the~     development of asthma, food allergy, skin infections and neurodevelopmental disorders. Recent~     advances identify skin barrier dysfunction to be the key initiator of AD and possibly~     allergic sensitization.~      Our central hypothesis is that daily emollient use from birth can prevent the development of~     AD in a community setting and into newborns unselected for risk. The results of a~     community-based clinical trial utilizing a pragmatic trial design will be immediately~     applicable to the population at large and will establish a new standard of care for all~     newborns.~   "
12030|NCT03409354|"~     A proof of concept randomized controlled trial (RCT) only evaluated the National University~     of Singapore's (NUS) T-Rehab tele-rehabilitation (TR) system at a home setting where~     rehabilitation was provided on an individual level. The previous RCT was also limited to~     stroke patients. In addition to stroke, there are many other conditions (such as fractures,~     lower limb joint replacement, musculoskeletal conditions) require and benefit from~     rehabilitation. The primary aims of the pilot evaluation study are: (i) To document patient~     adherence to TR, compared to usual care (ii) To estimate the extent to which TR improves~     functional status, compared to usual care and (iii) To estimate the cost effectiveness of TR,~     compared to usual care in eight different health conditions in Singapore.~   "
12031|NCT03409341|"~     This prospective, observational study will evaluate whether vitro testing of tumor tissue and~     white blood cells from patients with lung cancer who are being treated with immune checkpoint~     inhibitors and other standard of care approaches, predicts clinical response to these agents.~   "
12032|NCT03409328|"~     Young gay, bisexual, and other men who have sex with men (MSM) are disproportionately~     affected by HIV. Despite this burden, most HIV prevention interventions target adult MSM~     (most of whom identify as gay) and heterosexual youth, creating an urgent need for~     interventions for gay and bisexual adolescents. Further, self-identified bisexual men,~     especially adolescents, have been neglected in research. Therefore, little is known about~     factors that drive engagement in risk behavior among self-identified bisexual adolescent men.~     The goals of this study are to: (1) examine factors that drive engagement in HIV risk~     behavior and substance use among self-identified bisexual adolescent men; and (2) develop and~     pilot test a tailored HIV and substance use prevention intervention for this population.~   "
12033|NCT03409315|"~     Observational, multi-centre, prospective study to investigate the feasibility of centralized~     TDM of moxifloxacin and levofloxacin in MDR-TB patients by determining turn-around time~     between sampling and receiving dosing advice.~      In addition, the effect of TDM will be evaluated by comparing treatment results of~     prospective patients receiving TDM with historical controls without TDM.~   "
12034|NCT03409302|"~     Acceptance and Commitment Therapy (ACT) delivered face-to-face is an empirically supported~     intervention for the management of chronic pain (CP). However, increasing demands for cost~     reduction in healthcare services in addition to obstacles regarding physical access to~     treatment, highlight the need for innovative, cost-reducing, digital self-management~     interventions. Poor user engagement nonetheless, is a significant challenge often faced in~     digital interventions, which often results in poor adherence or even non-completion in~     treatment. In addition, very few digital trials appear to plan for adherence a-priori, when~     designing an intervention. To date there are only two ACT-based digital interventions for CP~     demonstrating significant improvements in pain-related disability and increased functioning,~     yet with small to medium effect sizes and poor adherence rates. However, several limitations~     of the studies such as the absence of a-priori adherence planning and lack of investigation~     of underlying mechanisms, makes it difficult to draw clear conclusions on the effectiveness~     of this new treatment modality for chronic pain and warrants further research. This study~     seeks to: a) explore how a brief adherence-planned digital ACT-based intervention for CP~     management, compared to an active control group and a wait-list control group improves~     targeted study outcomes such as functioning and quality of life, and b) investigate which~     processes of change mediate the targeted study outcomes. It is hypothesized that the brief~     ACT-based digital intervention in comparison to the active control group and wait-list will~     result in increased functioning, improved quality of life and reduced pain intensity. The~     results of the study are expected to shed more light on the utility of planning for adherence~     in digital interventions and effectiveness of ACT-based digital interventions and their~     underlying mechanisms in the management of CP.~   "
12035|NCT03409289|"~     This will be a prospective observational study of adult primary cardiac arrest patients~     presenting to Shands Emergency Department following ROSC or actively in cardiac arrest with~     subsequent ROSC after treatment in the emergency department.~   "
12038|NCT03409250|"~     This investigator initiated pilot study is designed to investigate the efficacy and safety of~     SD-OCT-guided intravitreal ranibizumab treatment in choroidal neovascularization (CNV) due to~     myopia. Newly diagnosed and active CNVs due to myopia are treated with one intravitreal~     injection of Ranibizumab 0.5mg (Lucentis) at baseline. During the follow up period of 12~     months monthly ophthalmological examinations including best corrected visual acuity (BCVA)~     and high resolution spectral-domain optical coherence tomography (SD-OCT) assessments are~     performed. Detection of persisting or new signs of CNV activity at OCT triggers ranibizumab~     re-treatment considering that any ranibizumab injections can maximally be applied as often as~     monthly.~   "
12039|NCT03409237|"~     Osmotherapy consists in the therapeutic use of osmotically active substances with the aim of~     reducing the volume and therefore the intracranial pressure. It therefore represents an~     essential component in the clinical management of cerebral edema and intracranial~     hypertension, whether they are a consequence of head trauma, ischemic or hemorrhagic stroke,~     and neoplasm or neurosurgical procedures.~      The current study aims at evaluating in vivo the effects on haemostasis parameters of~     hypertonic saline solutions at different concentration, as compared to mannitol, in patients~     with neuroradiological signs (CT / MRI) of cerebral edema / non-traumatic intracranial~     hypertension.~   "
12040|NCT03409224|"~     The purpose of this study is to compare changes in the body's self-defense (immune response)~     after two different treatments for small kidney tumors: 1) Cryoablation (freezing) therapy in~     which the tumor and a margin of normal kidney tissue are frozen and thawed twice with a~     needle probe and 2) radiofrequency ablation (RFA) in which radiofrequency energy delivered~     through a needle probe is used to heat tissue and thereby destroy a tumor.~   "
12041|NCT03409211|"~     This is a proof-of-principle, placebo-controlled, open label study to assess the improvement~     in the Treg counts and PASI Scores with PEVCO given at 1000 mg four times daily in patients~     with PsO (subjects may or may not have PsA) , who have active disease and are not currently~     receiving other therapy (as defined by the inclusion/exclusion criteria) compared to healthy~     subjects.~      The patients and healthy controls will receive placebo or PEVCO for a total of 9 weeks (3~     weeks for placebo, followed by 6 weeks for PEVCO). No topical or systemic medications will be~     used during this period.~   "
12042|NCT03409198|"~     Breast cancer is rarely curable after metastasis, and the therapeutic options are limited.~     Interestingly, the host immune response is strongly predictive for the effect of chemotherapy~     in subgroups of patients with breast cancer. The aim is to release the brake on the immune~     response by use of ipilimumab, which blocks CTLA-4 and may deplete regulatory T cells,~     combined with nivolumab (anti PD1). Importantly, it is possible that non-responders to~     nivolumab/ipilimumab (nivo/ipi) can be turned responders by use of immunogenic chemotherapy.~   "
12043|NCT03409185|"~     The purpose of this study is to seek academic/non-industry research funding support to~     independently investigate the incidence and density of lens glistenings in cataract patients~     who are implanted with the latest generations of intraocular lenses (IOL) manufactured by~     Alcon and AMO Medical Optics.~   "
12044|NCT03409172|"~     The main purpose of this study is to compare the effects of high intensity interval training~     and moderate intensity continuous training on inflammatory profile and metabolic markers,~     after 8 weeks of intervention trial in obese women.~   "
12045|NCT03409159|"~     Left atrial appendage (LAA) occlusion (LAAC) has been introduced to treat patients with~     indication of oral anticoagulation (OAC) for atrial fibrillation (AF) with contraindication~     to OAC. This registry aims to document all LAAC procedures in Austria.~   "
12046|NCT03409146|"~     Accuracy and Reliability of the Novii device (fetal heart rate, maternal heart rate and~     uterine activity) compared with Food and Drug Administration (FDA) approved techniques~   "
12047|NCT03409133|"~     The purpose of this study is to evaluate the effectiveness of providing sensation of the~     missing limb by applying small electrical current directly to the remaining sensory nerves~     via implanted stimulating electrodes. These small electrical currents cause the nerves to~     generate signals that are then transferred to your brain just like the information about the~     foot and lower limb used to be transferred to your brain prior to the amputation.~   "
12048|NCT03409120|"~     This study occurs during five visits that are already scheduled as part of Biomarkers to~     Guide Directional DBS for Parkinson's Disease (ClinicalTrials.gov Identifier: NCT03353688).~     If participants have dystonia associated with Parkinson's disease, the investigators will~     consent and administer one additional rating scale (Burke-Fahn-Marsden Dystonia Rating Scale)~     to assess the severity of dystonia.~   "
12049|NCT03409107|"~     The purpose of this multi-center study in non-dialysis subjects with anemia associated with~     CKD is to evaluate safety, efficacy and quality of life of daprodustat compared to placebo.~   "
12050|NCT03409094|"~     This is a study to report the change of ocular biometry of schoolchildren and adolescents as~     well as its association with birth parameters in China.~   "
12051|NCT03409081|"~     The purpose of this study is to provide expanded access to gilteritinib (ASP2215) for~     patients with FMS-like tyrosine kinase 3 (FLT3)-mutated relapsed or refractory acute myeloid~     leukemia (AML) or with FLT3-mutated AML in composite complete remission (CRc: [complete~     remission (CR), complete remission with incomplete hematologic recovery (CRi), complete~     remission with incomplete platelet recovery (CRp)]) with minimal residual disease (MRD)~     without access to comparable or alternative therapy.~   "
12052|NCT03409068|"~     C2-C4 compartment block compared to the Costaiola block, in the control of persistent~     postoperative pain (somatic and neuropathic) in patients undergoing carotid~     thromboendarterectomy~   "
12053|NCT03409055|"~     Pleural effusions occur commonly in patients recovering from cardiac surgery, however, the~     impact on outcomes is not well characterized. The purpose of this study is to characterize~     the outcomes and costs of cardiac surgery patients with pleural effusions All patients~     undergoing cardiac surgery between 2006 and 2013 were included in this observational,~     cross-sectional analysis using propensity matching~   "
12098|NCT03408470|"~     This is an open-label, 2-cohort study to evaluate the absolute bioavailability, absorption,~     distribution, metabolism and excretion of TD-1473 in healthy male subjects. Subjects in~     cohort 1 will receive a single oral dose of TD-1473 and a single intravenous bolus dose of~     [14C]-TD-1473. Subjects in cohort 2 will receive a single oral dose of [14C]-TD-1473 only.~   "
12054|NCT03409042|"~     The aim of this study is, first, to describe the evolution of the caloric compensation~     ability in infants from 3 to 15 months old and, secondly, to assess the links between changes~     in the caloric compensation ability and the individual characteristics (adiposity, age,~     gender, infant's eating behavior) and maternal feeding practices.~      Three series of measurements of caloric compensation abitlity were conducted: at 3-4 months~     old, at 10.5 months old and at 14.5 months old in the laboratory.~      In this study, a preload paradigm usually employed in children and adults to measure the~     caloric compensation ability was adapted to infants below 15 months old. The maternal eating~     behavior and their feeding practices were measured by questionnaires. The infants' height and~     weight were measured at the laboratory by trained experimenters.~   "
12055|NCT03409029|"~     The standard non-surgical treatment for muscle invasive bladder cancer is concurrent~     chemo-radiotherapy. This treatment is associated with long term side effects in around a~     third of patients with up to 12% suffering from grade 3-4 toxicity.~      Effective radiotherapy depends on delivering a curative dose to the target whilst minimising~     dose to surrounding tissues to reduce toxicities. As an organ that constantly varies in shape~     and position, achieving this in bladder irradiation is challenging. Cone beam Computed~     Tomography (CBCT) has allowed visualisation of soft tissue on treatment and hence~     image-guided treatment and improved accuracy, but the image quality of CBCT is suboptimal for~     distinguishing soft tissue boundaries. On the other hand, MRI scans produce superior soft~     tissue definition and visualisation of tumour bed. This would in turn allow for various ways~     of optimising treatment and potentially improving outcome.~      There have been a number of studies evaluating pelvic organ motion in bladder cancer as well~     as assessing different adaptive radiotherapy strategies. These have included individualized~     margins, plan of the day and adaptive techniques. Most of these studies have been carried out~     using CBCT imaging which is often poor quality with limited soft tissue contrast. MRI offers~     better visualization of the tumour bed and organs at risk (OARs). As a result, the~     utilisation of MRI in radiotherapy could allow for increased radiation dose to the tumour bed~     while maintaining minimal dose to surrounding soft tissue.~      This study will explore the role of MRI imaging in adaptive radiotherapy for bladder cancer~     with development of a number of theoretical treatment strategies.~   "
12056|NCT03409016|"~     This is a single-center, correlative pilot study evaluating potential biomarkers predictive~     of immune-related adverse events associated with immune checkpoint inhibitor therapy.~   "
12057|NCT03409003|"~     The purpose of this study is to conduct post-marketing surveillance of carglumic acid~     (Carbaglu) to obtain long-term clinical safety information. Carglumic acid was approved by~     the United States Food and Drug Administration (FDA) for treatment of acute hyperammonemia~     due to N-acetylglutamate synthase (NAGS) deficiency. Much of the FDA-required data is already~     collected through the Longitudinal Study of Urea Cycle Disorders (RDCRN Protocol #5101). This~     study will collect additional data on adverse events (interim events), adverse reactions,~     pregnancy, and fetal outcomes.~   "
12058|NCT03408990|"~     The purpose of this study is to evaluate the association of signals recorded and analysed~     with Ventica® Lung Function Testing System (LFTS) in infants and pre-schoolers during the~     whole night sleep with the gold standard for sleep recording events, polysomnography, in~     order to better understand the confounding factors for momentary changes in the impedance~     pneumography-derived tidal breathing flow-volume (TBFV) curves.~   "
12059|NCT03408977|"~     Aim: to determine the effect of gender on the responses to meal ingestion. Participants (10~     men and 10 women) will be instructed to eat a standard dinner the day before, to consume a~     standard breakfast at home after overnight fast, and to report to the laboratory, where the~     test meal will be administered 4 h after breakfast. Studies will be conducted in a quiet,~     isolated room with participants sitting on a chair. Participants will ingest a probe meal up~     to the level of maximal satiation. The probe meal will be served stepwise (150 Kcal every 5~     min). Perception of homeostatic (hunger/satiation, fullness) and hedonic (digestive~     well-being, mood) sensations will be measured at 5 min intervals 10 min before, during and 20~     min after ingestion at 10 min intervals.~   "
12060|NCT03408964|"~     Participants to the study will be assigned to 4 cohorts according to the stage of disease and~     planned antitumor treatment at time of study entry.~      In all patients, 8 ml of blood sample will be collected in EDTA tube for analysis of~     biological biomarkers in different time points.~   "
12061|NCT03408951|"~     Recorded cutaneous ECG containing arrhythmia events are separately analysed by an expert~     Electrophysiologist and the ISSD detection algorithm, to allow assessment of the correct~     detection of tachyarrhythmia events and discrimination of supra-ventricular arrhythmia of the~     algorithm,m compared to the expert.~   "
12062|NCT03408938|"~     The principle aim of this study is to detect the accurracy of Masimo Radical-7¿ Pulse~     CO-Oximeter in relation to laboratory hemoglobin and estimated blood loss in intraoperative~     blood transfusion practice during obstetric procedures with high risk of bleeding.~   "
12063|NCT03408925|"~     The aim of this study is to investigate the effect a specific exercise program on the~     incidence of injuries in the lower extremity. 72 elite orienteerers, aged 18-40 years, are~     allocated to an intervention or control group. The intervention group performs four specific~     exercises, four times a week (10 minutes per session) in conjunction with normal training.~     Injury data are collected every second week using valid injury questionnaire distributed by~     text messages over 14 weeks. Primary outcome is the incidence of substantial injuries in the~     lower extremity. Secondary outcomes are incidence of ankle sprains and the average~     substantial injury prevalence across the 14 weeks.~   "
12064|NCT03408912|"~     Around 50% of patients that present with ST Elevation Myocardial Infarction (STEMI) have~     residual disease in the non-culprit lesions. If the residual disease should be treated, what~     should guide intervention? Fractional Flow Reserve (FFR) has been proposed as a guide for~     intervention, however new developments in cardiovascular magnetic resonance (CMR) allows for~     non-invasive FFR measurements.~      If FFR from CMR can predict physiological significant stenosis as good as FFR from invasive~     angiography, unnecessary invasive producers can be avoided in patients with STEMI.~   "
12065|NCT03408899|"~     The purpose of this study is to evaluate the safety and pharmacokinetics of PC-1005 gel when~     used as a rectal microbicide in HIV-uninfected men and women (cis or transgender) with a~     history of consensual receptive anal intercourse.~   "
12066|NCT03408886|"~     This is a clinical trial of Microbiota Transplant Therapy (MTT) for adults with autism~     spectrum disorders (ASD) who have gastrointestinal problems.~      Previous research has shown that individuals with ASD have a low diversity of gut bacteria,~     and low diversity is generally associated with poor gastrointestinal (GI) health. We~     previously found that MTT therapy for children with ASD and GI symptoms was helpful in~     reducing their GI symptoms, reducing their ASD symptoms, and increasing their diversity of~     gut bacteria.~      This clinical trial will investigate the hypothesis that MTT therapy will be helpful for~     adults with ASD who have GI symptoms.~   "
12067|NCT03408873|"~     This is a prospective study using customized adherence enhancement (CAE) and long-acting~     injectable (LAI) antipsychotic in 30 individuals with bipolar disorder (BD) at risk for~     treatment non-adherence. The CAE approach is expected to improve treatment adherence, as well~     as improve BD symptoms, functioning and treatment attitudes among subjects with bipolar~     disorder.~   "
12068|NCT03408860|"~     Borderline personality disorder (BPD) is a commonly occurring, severe, and costly condition~     that interferes greatly with quality of life. Considerable comorbidity with other disorders~     and existing multicomponent treatments with largely untested putative mechanisms of action~     represent obstacles for effective dissemination of BPD treatment; in light of this gap, the~     purpose of the present study is to isolate the effects of individual treatment components on~     putative mechanisms implicated in both BPD. This study will answer important theoretical~     questions about the mechanism of treatment change, and might lead to more efficacious,~     cost-effective, and easily disseminable treatment strategies for BPD, a severe and~     understudied disorder.~   "
12069|NCT03408847|"~     Epidemiological studies suggest that daily intake of fruits and vegetables high in~     polyphenols or the addition of olive oil containing many polyphenols is associated with a~     reduced risk of chronic diseases including cardiovascular, metabolic, neurodegenerative, and~     inflammatory bowel conditions.~      In vivo experiments demonstrated that the administration of a diet associated with daily~     intake of extra virgin olive oil (EVOO) reduces histological lesions and symptomatology in~     rats with a dextran sulfate sodium (DDS) induced colitis. A diet supplemented with~     hydroxytyrosol (a component of olive oil) showed a reduction of the inflammatory process at~     the inflamed colon of the rats.~   "
12070|NCT03408834|"~     This study was to find out whether laparoscopic colorectal surgery is detrimental to the~     kidneys via PVI monitoring. To detect the kidney injury, so-called kidney troponin NGAL~     ,which gives earlier information than creatin in renal ischemic injury, was used.~   "
12071|NCT03408821|"~     This study seeks to determine the feasibility and efficacy of a Problem Solving Therapy~     intervention for the treatment of late life depression (LLD). Participants diagnosed with LLD~     will participate in 8 weekly sessions of Problem Solving Therapy, a form of talk-therapy,~     over a period of eight weeks. A Case Manager (CM) trained in this therapy will lead the PST~     sessions. Participants will attend a clinical assessment pre and post study intervention to~     assess depression severity, quality of life, anxiety, insomnia, functional disability, and~     participant's acceptability of the intervention. Additionally self-rated depression will be~     collected weekly over 8 weeks.~   "
12072|NCT03408808|"~     Study to examine the efficacy of Platelet Rich Plasma (PRP) to reduce recurrence in dorsal~     wrist ganglia (DWG). We will compare aspiration alone and aspiration with injection of PRP.~      We plan to recruit a maximum of 200 patients. We will assess the efficacy by contacting the~     patients by email or telephone at 6 weeks and 12 months. They will be asked to complete a~     questionnaire and a Patient Evaluated Measure score (PEMS). Adverse events will be screened~     for/ managed by a telephone call +/- review as necessary between 7 and 14 days.~   "
12073|NCT03408795|"~     Laparoscopic distal gastrectomy (LDG) is a common surgery in the surgical trainees. However,~     there is no assessment system to measuring the surgical skill of surgical trainees. The novel~     surgical assessment system, which called Global Operative Assessment of Laparoscopic~     Skills-Distal Gastrectomy (GOALS-DG) by the task analysis and the Delphi method have been~     developed. This study describes assessing the development of surgical skill by GOALS-DG in~     the initial experience of LDG.~   "
12074|NCT03408782|"~     This prospective observational study examines the associations of presence, duration, type,~     number and location of surgical drains with the risk of surgical site infections in a~     contemporary and multicentric cohort of general, orthopedic trauma and vascular surgery~     procedures.~   "
12075|NCT03408769|"~     Sexual health is one of the relevant parameters for assesing the quality of life.~      Improvement sexual and emotional function improves quality of life scores and depression or~     anxiety in curative phase.~      The purpose of the study is to assess the quality of sexual life of postmenopausal women with~     metastatic breast cancer in couples and to establish links with overall quality of life and~     the quality of the relationship.~   "
12076|NCT03408756|"~     This study is a prospective, single blinded, randomized, pilot study to compare the~     effectiveness and safety profile of oral versus subcutaneous route of administration of~     methotrexate in management of patients with moderate to severe psoriasis. The recruited~     participants with moderate to severe psoriasis will be randomized into treatment arms.~     Randomization will be done using computer generated random number table. The participants in~     the first treatment arm will receive 0.3 mg/kg ( upto a maximum of 25 mg/week ) of weekly~     oral methotrexate for 12 weeks or achievement of PASI 90 whichever is earlier while the~     participants in second treatment arm will receive subcutaneous methotrexate at 0.3 mg/kg/week~     for the same duration. The participants will be followed at regular intervals and monitored~     adequately for hematological, hepatotoxic and other adverse effects both clinically and~     through laboratory investigations according to methotrexate consensus guidelines during the~     treatment period. PASI, percentage of body surface area (BSA) involvement and DLQI will be~     assessed at each follow up visit and at the end of 12 weeks. The treatment will be tapered at~     the rate of 5 mg/2 weeks and stopped after 12 weeks or achievement of PASI 90 whichever is~     earlier.. Follow ups will be done at every 2 weeks until treatment completion (12 weeks) and~     at every 4 weeks till 24 weeks after completion of treatment.~      The primary outcome measures will be achievement of PASI 90 (90 % reduction in psoriasis area~     severity score (PASI) compared to baseline).The secondary outcomes will be improvement in~     DLQI (dermatology life quality index), relapse rate and adverse events if any.~   "
46698|NCT02955628|"~     This is a multicentre, open-label, phase II study of ibrutinib 560 mg in combination with~     R-ICE for treatment of transplant-eligible relapsed/refractory diffuse large B-cell lymphoma.~   "
12077|NCT03408743|"~     The overall objective of the proposed research is to reduce the incidence of sexually~     transmitted infections (STIs) among college students. The investigators propose to accomplish~     this by using the innovative, engineering-inspired multiphase optimization strategy (MOST) to~     develop a highly effective, appealing, economical, and readily scalable internet-delivered~     behavioral intervention targeting the intersection of alcohol use and sexual risk behavior.~     The rate of STIs on college campuses is alarming: one in four college students is diagnosed~     with an STI at least once during their college experience. Sexual activity when drinking~     alcohol is highly prevalent among college students. Alcohol use is known to contribute to the~     sexual risk behaviors that are most responsible for the transmission of STIs, namely~     unprotected sex, contact with numerous partners, and hook-ups (casual sexual encounters).~     Few interventions have been developed that explicitly target the intersection of alcohol use~     and sexual risk behaviors, and none have been optimized. In order to reduce the incidence of~     STI transmission among this and other high-risk groups, a new approach is needed. MOST is a~     comprehensive methodological framework that brings the power of engineering principles to~     bear on optimization of behavioral interventions. MOST enables researchers to experimentally~     test the individual components in an intervention to determine their effectiveness,~     indicating which components need to be revised and re-tested. Given the high rates of alcohol~     use and sex among college students, the college setting provides an ideal opportunity for~     intervening on alcohol use and sexual risk behaviors. The proposed study will include a~     diverse population of college students on 4 campuses which will increase the generalizability~     of the findings. The specific aims are to (1) develop and pilot test an initial set of online~     intervention components targeting the link between alcohol use and sexual risk behaviors, (2)~     use the MOST approach to build an optimized preventive intervention, and (3) evaluate the~     effectiveness of the newly optimized preventive intervention using a fully powered randomized~     controlled trial (RCT). This work will result in a new, more potent behavioral intervention~     that will reduce the incidence of STIs among college students in the US, and will lay the~     groundwork for a new generation of highly effective STI prevention interventions aimed at~     other subpopulations at risk.~   "
12078|NCT03408730|"~     A Controlled Trial to Assess the Lot-to-lot Consistency of Sci-B-Vac™ in Adults~   "
12079|NCT03408717|"~     Pre-existing pain and severe postoperative pain are predictors of persistent pain after~     surgery, but a complete understanding on the development of persistent pain is still lacking.~     The study aims to identify clinically relevant and genetic risk factors for persistent~     postsurgical pain that can be reliably distinguished statistically.~   "
12080|NCT03408704|"~     The investigators have developed an antibiotic stewardship program (ASP) to increase~     adherence to the Swedish guidelines for managing patients with a sore throat. This is a~     randomized controlled trial where primary health care centers are randomised to get the ASP~     or not. The adherence to the Swedish guidelines are measured in all participating centers.~   "
12081|NCT03408691|"~     This is a single-site exploratory study aiming to demonstrate the effect of a fresh fermented~     dairy drink containing a probiotic strain on stress-related intestinal hyperpermeability in~     students defending a bachelor's or master's thesis in front of a jury at the University of~     Leuven (Belgium).~   "
12082|NCT03408678|"~     There is little known about menopause in African women, whose phenotype differs to Caucasian~     women, and no data is available on middle-aged black South African men. Accordingly, the~     study aims to examine the changes in sex hormone levels over the menopausal transition in~     women, and in men of the same age, and explore the effects on body fat distribution and~     insulin sensitivity and secretion, dissecting the specific roles of glucocorticoids and~     inflammatory mediators, in the context of HIV.~      Research questions and hypotheses:~        1. Does the decrease in sex hormones that occur with ageing increase circulating cortisol~          and/or inflammatory markers, and directly and/or indirectly via increases in central fat~          mass, decrease insulin sensitivity in middle-aged black South African men and women?~           Hypothesis: The mechanism underlying the decrease in insulin sensitivity (outcome)~          associated with the decline in sex hormones (exposure) that occurs with ageing is~          mediated via an increase in centralization of body fat (mediator), which is due to an~          increase in inflammation and cortisol production.~        2. How does HIV alter the relationship between sex hormones, inflammation and cortisol~          levels, and subsequently body fat distribution and insulin sensitivity?~           Hypothesis: HIV infection will exacerbate the effects of the decline in sex hormones~          with ageing, leading to further increases in inflammation and cortisol production, and a~          consequent increase in the centralization of body fat and decrease in insulin~          sensitivity.~        3. Does adipose tissue glucocorticoid and inflammatory gene expression differ between pre-~          and post-menopausal women, with and without HIV, and how do these relate to body fat~          distribution and insulin sensitivity and secretion?~      Hypothesis: Adipose tissue estrogen receptor beta (ERβ), 11-beta hydroxysteroid dehydrogenase~     type 1 (11HSD1) activity and pro-inflammatory markers will be higher in post- compared to~     pre-menopausal women, which will be exacerbated by HIV infection. This will be associated~     with down-regulation of subcutaneous adipose tissue (SAT) adipogenic genes, increased~     visceral adipose tissue (VAT), a decrease in insulin sensitivity and secretion, and~     consequently an increased risk for type 2 diabetes (T2D).~   "
12083|NCT03408665|"~     Intervention research involving the human person, phase II, prospective, multicentric,~     non-randomized and multi-cohort study. The eligibility criteria are broad, on purpose, so~     every patient, able to be treated by SBRT and unable to participate in another trial (non~     eligible patient or non included centers), can be included in this national study, in a~     prospective way.~   "
12084|NCT03408652|"~     Multicenter, randomized, open-label, 2-arm, parallel-group, phase III study whose goal is to~     assess the efficacy and safety profile of bone-targeted treatments (Arm A: denosumab or~     zoledronic acid) versus the control arm (Arm B: no specific treatment) in patients with bone~     metastases under targeted therapy for Metastatic Renal Cell Carcinoma.~   "
12085|NCT03408639|"~     This Phase III, randomized, two-armed, parallel, double-blind, active-controlled clinical~     trial is designed to compare efficacy and safety of CinnaPoietin® (Beta erythropoietin) and~     Eprex® (epoetin alpha) on the treatment of anemia in 156 End-Stage Renal Disease hemodialysis~     patients. 156 patients have been planned to randomize and assign to receive CinnaPoietin® or~     Eprex® for a 26-week period. Administration dose for patients who are treated with~     erythropoietin is the similar dose of the previously administered amount (IV or SC without~     any change). After then, dose adjustment will be made based on patients' response. The~     primary objective of this study is to compare the efficacy of CinnaPoietin® with Eprex®. The~     secondary objectives of this study are further comparison and evaluation of efficacy along~     with safety between CinnaPoietin® and Eprex®.~   "
12086|NCT03408626|"~     This study will be conducted to assess the efficacy of caries excavation using the~     papain-based chemo-mechanical method (Brix 3000) in comparison to conventional rotary tools~     in the reduction of the bacterial population in occlusal carious cavities~   "
12087|NCT03408613|"~     Many adults who are overweight have obstructive sleep apnea (OSA) which disrupts sleep and~     makes it difficult to breath during the night. OSA increases the risk for a person to become~     insulin resistant and diabetic. It is not known why OSA causes this problem, i.e., whether it~     is disrupted sleep or lack of oxygen., which can change how the body handles glucose in~     adipose tissue, muscle tissue and liver.~      The purpose of this research study is to determine the key issues and mechanisms responsible~     for dysregulated glucose metabolism in people with OSA. The investigators will do this by~     comparing glucose metabolism in people who have OSA, and those who do not, and by evaluating~     the effect of treating OSA by providing continuous positive airway pressure (CPAP) or simply~     oxygen during the night.~      The proposed study will evaluate the primary causes(s) (hypoxia, sleep fragmentation, or~     both) and pathophysiological mechanisms responsible for the OSA-associated metabolic~     abnormalities. Knowing the primary cause of Obstructive Sleep Apnea and pathophysiological~     mechanisms responsible for the OSA-associated metabolic abnormalities could help develop~     potentially novel therapeutic strategies to provide treatment for adults in improving OSA and~     associated comorbidities.~   "
12088|NCT03408600|"~     Early detection and timely therapeutic intervention can improve the prognosis of patients~     with sepsis. However, early diagnosis of sepsis can be difficult; because determining which~     patients presenting with signs of infection during an initial evaluation, do currently have,~     or will later develop a more serious illness is not easy.~      Physiological deterioration often precedes clinical deterioration as patients develop~     critical illness. In this study, the investigators aim to evaluate vital signs in a global~     cohort of patients with acute secondary peritonitis, determining which parameters are~     statistically significant to predict in-hospital mortality and ICU admission.~   "
12089|NCT03408587|"~     This is an open-label Phase 1b clinical study of ipilimumab in combination with intravenous~     CVA21 in subjects who have uveal melanoma metastatic to liver.~   "
12090|NCT03408574|"~     Prior research has shown that a chemical system in the brain called the cholinergic system is~     primarily responsible for cognitive symptoms seen in people with dementia. While therapeutic~     benefits are clear in dementia, what remains uncertain is the role that the cholinergic~     system in general and a subset of receptors called the nicotinic system plays in cognition in~     healthy non-demented older adults (referred to as normal cognitive aging). This is critical~     because the ever growing healthy aging population will show declines in cognition that fall~     short of dementia but still impact functional abilities and independence. Maintaining good~     nicotinic system functioning throughout adulthood may lessen the cognitive symptoms of aging.~     At this time, it is not clear what the biological cause of age-related changes in cognition~     is. This study will examine the role of the nicotinic system in the healthy aging brain and~     examine its role in memory and thinking processes in older and younger adults.~   "
12091|NCT03408561|"~     This pilot clinical trial studies how well social media listening works in improving clinical~     trial recruitment in patients with cancer. Social media listening and recruitment on Twitter~     may enhance enrollment for cancer-related clinical trials.~   "
12092|NCT03408548|"~     The aim of this study is to evaluate the effect of the probiotic therapy as an adjunct to~     non-surgical periodontal treatment in patients diagnosed with Generalized Chronic~     Periodontitis. Clinical study's hypothesis is that with the use of probiotic therapy, the~     standard treatment could be enhance.~   "
12093|NCT03408535|"~     The study will assess the feasibility of conducting a full-scale clinical trial of the~     effectiveness of an online rehabilitation program for adults living with hearing loss. The~     program aims to help people use their hearing aid(s) and interact in social settings more~     effectively. The program is made up of 5 modules that cover different topics, such as hearing~     aids, communication strategies, and relaxation techniques.~   "
12094|NCT03408522|"~     Major adverse cardiac events (MACE) are a leading cause of mortality in patients undergoing~     noncardiac surgery. Patients with perioperative myocardial injury (PMI), defined as either~     myocardial infarction and lower elevations in cardiac troponin, are also at substantially~     increased risk of additional cardiac and noncardiac complications. Accordingly, it is~     plausible to assume that PMI negatively affects quality of life in terms of disability. The~     aim of this study is to investigate and compare the independent prognostic effects of the~     different PMI phenotypes (myocardial infarction and non-infarct troponin elevations) and~     noncardiac complications on disability in patients undergoing elective noncardiac surgery.~   "
12095|NCT03408509|"~     Cognition encompasses memory, attention, language and other brain capacities that are~     necessary for good quality of life and independence. Age-related cognitive decline starts at~     the third decade of life and in some cases can start to impact daily functioning in the late~     forties. Dementia is the most devastating consequence associated with age-related cognitive~     decline. Recent studies indicate that improving cognition by means of intensive computerized~     brain training can mitigate some aspects of agerelated cognitive decline, and may even have a~     role in preventing or delaying dementia onset. Critically, the capacity of a given individual~     to improve their cognitive performance after training is fundamentally related to engagement~     with the exercises. Currently, little is known about how to apply intensive computerized~     cognitive training effectively in the health system, ensuring engagement and best progress.~     This project aims to tackle this challenge by developing, applying and testing personalized~     approaches to implement cognitive training in daily life of older adults that were recently~     evaluated at Memory Clinics and their care partners. The community readiness approach will be~     implemented using semi-structured interviews, conducted with subjects that may be interested~     in cognitive training, key informant, and key stakeholders. Using this information, the~     investigators will design an individualized training program and follow up its application in~     a feasibility trial. Twenty participants, recently evaluated at different Memory Clinics in~     Ireland, will be recruited, interviewed and invited to engage, over the ensuing 2 to 3~     months, in computerized cognitive training. Subjects will be assessed after completion of the~     intervention for training adherence and individual gains on the computerized exercises. In~     order to gain insight about regional specificities of the approach the investigators will~     perform a parallel project using the same methodology in Brazil. This project is expected to~     inform the future implementation of cognitive training in public health policies for older~     adults.~   "
12096|NCT03408496|"~     Muscle stretching is a therapeutic technique commonly used by physiotherapists, but for the~     treatment of fibromyalgia it still has weak evidence to support its real effect. On the other~     hand, myofascial mobilization in the location of tender points, as it is the solution for the~     population, demonstrating effects on the improvement of the symptoms, but not yet achieving~     the minimal clinically important change. In this context, myofascial release guided by~     physiological chains, so far not studied, is presented as an alternative to improve pain and~     quality of life in patients with fibromyalgia because it acts in a global way and, probably,~     more effective.~      This study evaluates the effect of myofascial release of the trunk physiological chains and~     muscle stretching on pain, quality of life and functional capacity of patients with~     fibromyalgia when compared to the control group.~   "
12097|NCT03408483|"~     Peripheral nerve blocks for joint and extremity surgeries have long been proven to provide~     effective post-operative analgesia. Of these surgeries, total hip arthroplasty (THA) remains~     one of the most common orthopedic procedures in the United States with approximately 300,000~     operations performed annually. At our institution, post-operative analgesia in these patients~     is primarily provided through parenteral and oral opioid medications. Quadratus lumborum~     blocks (QLB) have been described and implemented for various surgical procedures including~     caesarean and laparoscopic ovarian surgery. Recently, there has been increasing interest in~     the efficacy of quadratus lumborum blocks for THA. Currently, case reports have established a~     precedent regarding the efficacy of the QLB for THA in providing superior analgesia and~     decreasing visual analog pain scores (VAS), but randomized trials are still lacking. The goal~     of this study is to compare pain scores (VAS), opioid consumption, physical therapy scores,~     and patient and surgeon satisfaction in patients that receive QLB versus no peripheral nerve~     blockade in patients undergoing THA. The results of this study have the potential to change~     standard of care for patients undergoing THA.~   "
12100|NCT03408431|"~     In a previous study, NCT03147469, the investigators found that the vocal cords were more~     easily visualized by fiberoptic bronchoscopy with neck extension positioning. On the basis of~     this finding, the investigators are going to conduct a randomized controlled trial to~     evaluate the effect of neck extension on the success rate of blind intubation through~     laryngeal mask.~      Participants undergoing general anesthesia will be randomly assigned to group E (with neck~     extension) or group C (with neutral position). Ambu® AuraGain™ laryngeal mask will be placed~     first, and then, a lubricated endotracheal tube will be gently intubated through the~     laryngeal mask. The participants will be mechanically ventilated with an endotracheal tube if~     blind intubation succeed. Blind intubation will be performed with a maximum of two attempts.~     If all attempts failed, the laryngeal mask will be removed and the tube will be intubated~     using a direct laryngoscopy.~      The primary outcome of this study is the success rate of blind intubation within a first~     attempt. Secondary outcomes included overall success rate of blind intubation within a~     maximum of two attempts, time for blind intubation, the incidence of postoperative~     hoarseness, cough, and sore throat, and any obvious complications related to airway~     management such as bleeding, airway trauma, dental fracture, aspiration, or bronchospasm.~   "
12101|NCT03408418|"~     The effect of leucocyte- and platelet-rich fibrin (L-PRF) for enhancing the healing after~     dental extractions is still a matter of debate. The available literature suggests that L-PRF~     performs positive effect to improve alveolar preservation resulting in less bone resorption~     on extraction sockets. L-PRF is a second generation of platelet concentrate produced without~     biochemical blood manipulation. L-PRF is composed by three key parameters: first, the~     presence of platelets; second, the presence of leucocytes; third, the density and complex~     organization of the fibrin matrix architecture produced by a natural polymerization process.~     The theory is that this key parameters acts to produce a faster bone healing.~   "
12102|NCT03408405|"~     We propose to study the use of purified porcine Acthar Gel (ACTHAR, Mallinckrodt~     Pharmaceuticals) for treatment of steroid resistance nephrotic syndrome (SRNS) in a~     prospective pilot study. We plan to enroll 25 children between the ages of 2 to 21 years.~     Children fulfilling strict inclusion criteria, whose parents agree to written informed~     consent after institutional IRB approval for the study, will be enrolled. Purified porcine~     Acthar Gel will be administered SQ to all children using a defined treatment protocol for a~     period of six months. Renal function, urine protein excretion, serum albumin levels, blood~     pressure and growth parameters will be monitored closely on all patients. Baseline urine~     protein excretion will be compared to end of treatment levels to determine successful~     response to therapy. There will be an 18 month enrollment period, 6 month treatment period~     and a 12 month follow-up period.~   "
12103|NCT03408392|"~     This study is open-label, randomized two-way cross-over study to determine if cefixime 200~     mg/5 mL powder for suspension (test formulation: SKF101804) is bioequivalent to cefixime 200~     mg/5 mL suspension reference formulation. Study will be conducted in 28 healthy adult~     subjects under fasting conditions. There will be two treatment periods and each subject will~     participate in both periods. The washout period between both treatment periods will be 7-14~     days. Subjects will be randomized to either of treatment sequences of reference followed by~     test or test followed by reference to receive a single dose of test or reference formulation~     on Day 1 in each treatment period. The study will last for 5 to 7 weeks.~   "
12104|NCT03408379|"~     Sub arachnoid hemorrhage consecutive to intracranial aneurysm rupture is a devastating~     disease. Predictors of intracranial aneurysm rupture are limited and focus mainly on size and~     location. Platelet activation may have a deleterious role on aneurysm rupture. The assumption~     is that patients with ruptured intracranial aneurysm will present a higher rate of platelet~     activation compared to patients with non ruptured aneurysms.~   "
12105|NCT03408366|"~     This study is being done to find out if Spectrum Near-Infrared (NIR) imaging with Indocyanine~     Green (ICG) dye can help measure blood flow around an incision before and after the surgeon~     closes the incision with staples or sutures.~      The Spectrum NIR imaging system uses a handheld camera that produces a special type of light~     that can help surgeons see things during surgery that are difficult to see with the naked~     eye, for example, cancer tissue versus healthy tissue. Spectrum NIR imaging has been approved~     by the Food and Drug Administration (FDA) as a tool that is widely used during surgery.~      ICG dye is a sterile solution that can be seen with Spectrum NIR imaging. This dye, used with~     Spectrum NIR imaging, allows surgeons to see blood flow to parts of the body during and after~     surgery. Making sure that there is enough blood flow to the surgical site helps to promote a~     less complicated recovery.~   "
12106|NCT03408353|"~     The goal of this research study is to create a bank of research samples and a database of~     clinical and risk information from women undergoing routine screening mammograms, for use in~     future research related to breast cancer, other cancers, and women's health. This research~     study will collect mammogram images, blood samples, and clinical information.~   "
12107|NCT03408340|"~     This study is a prospective, randomized, non-blinded clinical trial examining the use of~     paravertebral peripheral nerve block in the neonatal and infant populations. The primary aim~     of this study is to determine the feasibility of studying whether a single-shot paravertebral~     nerve block is effective in providing intraoperative and postoperative pain control in~     infants undergoing a thoracotomy for coarctation of the aorta. This will be determined by~     comparing consumption of narcotics, expressed as morphine equivalents, in the standard of~     care and intervention groups.~   "
12108|NCT03408327|"~     The object is to develop a physical activity promotion program by applying social cognitive~     theory and wearable technology and evaluate its feasibility in people with MI~      Stage I: Accuracy, Acceptability, Feasibility. Stage II: Effectiveness Analysis~      In stage II, will conduct a single-blinded, randomized controlled study. 90 participants will~     be randomly assigned to experimental group or control group. The intervention for both groups~     will last for 12 weeks, with a 12-week of follow-up. The measurements include physical~     activity level, physical fitness, cognitive function and sleep quality, as well as the~     moderators of the effectiveness of program.~   "
12174|NCT03407469|"~     The goal of this research study is to learn about the quality of life, experiences with~     treatment, and healthcare costs of patients who are receiving long-term treatment for venous~     thromboembolism (VTE) that is related to cancer.~      This is an investigational study. Up to 260 participants will be enrolled in this multicenter~     study. Up to 170 will take part in MD Anderson.~   "
12109|NCT03408314|"~     PediQUEST Response proposes a new system of care that expects to improve quality of life in~     children, adolescents, and young adults with advanced cancer and their parents. The~     investigators want to learn whether patients that are cared for using PediQUEST Response do~     in fact feel better than those receiving usual care.~      National recommendations call for early palliative care (PC) integration for seriously ill~     children to ease suffering, however, very few randomized controlled trials (RCTs) have~     evaluated whether PC improves child and family outcomes. In prior work, the investigators~     developed the Pediatric Quality of Life and Evaluation of Symptoms Technology (PediQUEST/PQ),~     a software that collects electronic Patient-Reported Outcomes (e-PROMS) and generates~     feedback reports.~      Now, the PI and research team developed PediQUEST Response (Response to Pediatric Oncology~     Symptom Experience). PediQUEST Response includes an enhanced PediQUEST system (web-based and~     with an App that allows to answer surveys and see reports), that is coupled with early~     integration of a palliative care consulting team (Response team). This dual strategy will~     help to standardize the family report of distress, which will be done through the PediQUEST~     system. It will also help standardize the providers' response to such distress, as providers~     will be specifically trained. Pilot work for PediQUEST Response found it feasible, well~     received by families and oncologists, and potentially effective.~      Thus, the overall goal of this study is to conduct a RCT of PQ Response versus usual care at~     four large pediatric oncology centers among 136 children ≥2 years old with advanced cancer.~     Hypotheses include a) children receiving the intervention will have better (higher) quality~     of life scores b) parents of children in the intervention group will report better~     state-anxiety, depression and symptom-related stress scores, and c) intervention group~     families will demonstrate higher levels of activation.~   "
12110|NCT03408301|"~     This study evaluates the influences of the status of sympathovagal balance before tourniquet~     deflation on a decrease in arterial blood pressure following the deflation during total knee~     replacement arthroplasty~   "
12111|NCT03408288|"~     The investigators hypothesize that incorporation of a colorimetric scale on urine collection~     bags to estimate degree of hematuria would allow better characterization of urine by~     healthcare staff thus leading to improved patient care.~   "
12112|NCT03408275|"~     During pregnancy lead crosses the placenta freely and can have adverse effects on the fetus,~     with the potential for life-long impact on the child. Identification of dietary patterns and~     food groups in pregnancy in relation to measures of lead status could provide a more useful~     alternative to a nutrient-specific advice to minimise fetal exposure to lead during~     pregnancy. The aim is to evaluate whether dietary patterns and food groups are associated~     with blood lead concentrations in pregnancy.~   "
12113|NCT03408262|"~     This is a randomised two-part Phase I study which will explore the impact of different~     boosting options (MVA-CN54 and recombinant CN54gp140 protein) for oral Adenovirus serotype 4~     vector prime expressing HIV-1 CN54 envelope (Ad4-EnvCN54) designed to optimize systemic and~     mucosal antibody responses.~      Part 1 is exploratory and designed to select conditions capable of promoting enhanced~     systemic and mucosal B cell responses in a limited number of participants. Part 2 is~     dependent upon Part 1 and is designed to study groups selected on performance in part 1 in an~     expanded number of subjects. Data from both stages will be combined for safety and~     immunological analyses.~   "
12114|NCT03408249|"~     The objective of the IBDoc® user performance evaluation is to demonstrate the ease-of-use of~     the IBDoc® calprotectin home test to allow patients with inflammatory bowel disease (IBD) to~     independently and correctly determine calprotectin concentration in their own stool sample.~     The study is based on Chapter 8 of the International Organization for Standardization (ISO)~     Standard, ISO 15197:2013 In vitro diagnostic test systems - Requirements for blood-glucose~     monitoring systems for self-testing in managing diabetes mellitus. The study is a~     prospective, multicenter study, not blinded for patients, and includes a total of 61~     patients.~   "
12115|NCT03408236|"~     To determine the efficacy and safety of Botulax® in treatment of crow's feet line~   "
12116|NCT03408223|"~     RATIONALE: Giving chemotherapy and total marrow and lymphoid irradiation before allogeneic~     hematopoietic cell transplant helps stop the growth of leukemia cells. It may also stop the~     patient's immune system from rejecting the donor's stem cells. When the healthy stem cells~     from a donor are infused into the patient they may achieve brand new hematopoietic recovery.~     Sometimes the transplanted cells from a donor can make an immune response against the body's~     normal cells, resulting in graft versus-host disease.~      PURPOSE: This study is to evaluate the toxicity and efficacy of total marrow and lymphoid~     irradiation conditioning when given together with combination chemotherapy and allogeneic~     peripheral blood stem cell transplant in treating patients with high-risk acute leukemia.~   "
12117|NCT03408210|"~     RATIONALE: Giving chemotherapy and total marrow and lymphoid irradiation before allogeneic~     hematopoietic cell transplant helps stop the growth of leukemia cells. It may also stop the~     patient's immune system from rejecting the donor's stem cells. When the healthy stem cells~     from a donor are infused into the patient they may achieve brand new hematopoietic recovery.~     Sometimes the transplanted cells from a donor can make an immune response against the body's~     normal cells, resulting in graft versus-host disease.~      PURPOSE: This study is to evaluate the toxicity and efficacy of total marrow and lymphoid~     irradiation conditioning when given together with combination chemotherapy and allogeneic~     peripheral blood stem cell transplant in treating patients with myelodysplastic syndrome or~     acute leukemia.~   "
12118|NCT03408197|"~     In this study two warming methods will be compared in knee arthroplasty surgery. Barrier~     EasyWarm will be used in the study group and BairHugger upper body warming blanket in the~     control group. Both groups will be prewarmed 30 minutes before spinal anaesthesia. In the~     operating room warming will be continued with the same warming method. Primary end point is~     core temperature after arriving to post anaesthesia care unit. Hypothesis is that Barrier~     EasyWarm is not inferior to BairHugger in preventing inadvertent intraoperative hypothermia.~   "
12119|NCT03408184|"~     An inguinal hernia is one of the most common disorders requiring surgical repair in~     pediatrics. The effective treatment of postoperative pain in infants and children is~     challenging. Although the use of opioid analgesics is generally safe, adverse effects occur~     frequently, so the use of alternative analgesic techniques when available to improve~     postoperative analgesia while limiting opioid-related adverse effects, that is why there is~     an increase in the use of regional anesthetic techniques in infants and children.~   "
12140|NCT03407911|"~     The purpose of the study was to evaluate, from a microbiological point of view, microbiota~     around teeth and implants in the same patient affected by periodontal disease and~     peri-implant disease, all compared with a healthy tooth. From the identification of~     particular bacterial species in the examined sites, it is intended to be traced back to the~     identification of a clear etiopathogenic process, which may shed light on the similarities~     and differences between the two diseases. In recognition of these mechanisms, the~     investigators think to develop new therapeutic strategies for the future.~   "
12120|NCT03408171|"~     Chronic liver disorders (CLD) are a major cause of morbidity and mortality for individuals in~     the US. Though serologic analysis will often lead to a conclusive diagnosis, liver biopsy~     remains an important method for helping to determine the etiology and stage of LD.~     Percutaneous liver biopsy (PLB), transjugular liver biopsy (TLB) and surgical liver biopsy~     (SLB) are alternative methods for obtaining hepatic tissue. In recent years endoscopic~     ultrasound guided-liver biopsy (EUS-LB) has come to the forefront as a safe and effective~     method for obtaining tissue in CLD. There are several studies of the safety of EUS-LB as well~     as the adequacy of specimens obtained in this fashion. Most studies involve a 19-g needle,~     therefore in this study we hope to compare the tissue yields of a 19-g FNB needle, in~     comparison to conventional 19-g FNA needle. We predict that 19-g FNA and 19-g FNB needle will~     demonstrate similar diagnostic accuracy, with less visible blood artifact. Similarly, we~     predict the safety to be equal.~   "
12121|NCT03408158|"~     By detecting platelet antibodies of participants and then further to identify their genotype~     and analyzing laboratory examination, the investigators will obtain positive frequency of HPA~     antibodies, the distribution of HPA antigen and antibodies, effect of matching platelet~     transfusion, all of which in favor of draw a conclusion that it is very important to carry~     out HPA antibody detection and matching transfusion in early phase.~   "
12122|NCT03408145|"~     The investigators believe that amniotic tissue allografts may be an effective modality to~     treat osteoarthritis (OA) of the knee. One important mechanism of action may be stimulation~     of the synovial cells to increase production of endogenous hyaluronic acid (HA). A second~     mechanism may be the increase in the anabolic factors and a decrease in degenerative factors~     in the joint. The Investigators propose to quantify the concentration of HA and selected~     anabolic and degradative factors in synovial fluid aspirate pre and post implantation. While~     the treatment provided is designed to provide pain relief for symptoms, the purpose of this~     study is to learn more information about the impact of amniotic tissue allografts on~     inflammatory markers and growth factors in the knee joint.~   "
12123|NCT03408132|"~     This is a repeated dose, open label trial investigating safety, efficacy, PD and PK of FE~     203799 in 6 patients with SBS and intestinal insufficiency (SBS-II). The patients will~     receive a subcutaneous (SC) dose of 25 mg FE 203799 once weekly for 4 consecutive weeks, and~     efficacy parameters and PK will be assessed after the fourth dose. Safety follow up~     assessments will be performed 4-6 weeks after the last dose.~   "
12124|NCT03408119|"~     The goals of this study are 1) to investigate the extent to which dried plum improves bone~     health by measuring bone density (a measure of bone strength) of whole body, hip, and~     forearm, indicators of bone formation and bone breakdown, and 2) to determine the~     anti-inflammatory effects of dried plum by assessing biomarkers of inflammation.~     Additionally, relevant medical history and lifestyle variables will be recorded.~   "
12125|NCT03408106|"~     Prospective Clinical Trial of HIV+ Living Donor Kidney Donation for HIV+ Recipients~   "
12126|NCT03408093|"~     The primary objective of the study is to evaluate the adherence to the treatment with~     interferon beta-1b, in patients diagnosed with isolated syndrome (CIS), relapsing-remitting~     multiple sclerosis (RRMS), or secondary progressive multiple sclerosis (SPMS) who had more~     than 6 months in treatment.~   "
12127|NCT03408080|"~     24 adults, between the ages of 18 and 75 years, with cerebellar ataxia will be enrolled in a~     12 week trial of BHV-4157 for treatment of ataxia. BHV-4157 is a pro-drug of riluzole (which~     is currently FDA-approved for ALS, Lou Gehrig's disease). There will be 5 visits to UCLA~     required--Screening when general and neurological examination, blood and urine testing, ECG,~     and questionnaires will be administered; Baseline when general and neurological examination~     and questionnaires will be administered and study drug dispensed; Week 4 and Week 12 when~     general and neurological examination, blood and urine testing, ECG, and questionnaires will~     be administered; 2 weeks after finishing study drug when general examination and blood~     testing will be completed. There is an option for a 36 week extension of the study drug~     trial.~   "
12128|NCT03408067|"~     In several hospital clinical trials, the nutritional intervention has been proven to be~     effective in preventing and/or reducing malnutrition. Therefore, a procedure to identify the~     risk of malnutrition or malnourishment in hospitalized patients is necessary to guarantee an~     adequate and timely nutritional treatment.~      Aims: to compare two validated nutritional screening tools: NRS 2002 and SGA. These are used~     to identify the risk of malnutrition or malnourishment in hospitalized patients.~      Patients and Methods: The study is currently carried out at the Federico II University~     Hospital of Naples, Italy. The in patients admitted in the Clinical Wards since September~     2016 are being evaluated. The two screening test results and the assessment of the patients'~     parameters are collected within 72 hours following admission. Age, sex, height, weight, Body~     Mass Index (BMI), calf circumference and dominant hand of the participants are being noted.~     Venous blood samples are collected for routine biochemistry and inflammatory parameters ; all~     measurements are determined by routine laboratory methods at the Department of Laboratory~     Medicine of the University Hospital Federico II, Naples.~   "
12129|NCT03408054|"~     Oxytocin causes myometrial contraction via the oxytocin receptor (OTR). Desensitization of~     the OTR after exposure to oxytocin has been demonstrated in previous studies. The resultant~     need for a higher oxytocin dose to cause adequate uterine contraction in vivo has also been~     demonstrated in laboring women having received oxytocin for labor augmentation.~      Achieving rapid uterine relaxation can be invaluable for maternal and fetal wellbeing in some~     acute obstetric emergency settings. Nitroglycerin has become a commonly used agent for~     achieving rapid uterine relaxation amongst obstetric anesthesiologists.~      Previous studies have concluded that oxytocin can be used to re-establish uterine tone~     following nitroglycerin mediated relaxation. However, no studies to date have looked at the~     effects of nitroglycerin mediated relaxation of uterine muscle that has undergone oxytocin~     receptor desensitization. Nor has the response to oxytocin re-exposure and return of~     contractility in desensitized myometrium (following nitroglycerin) been examined.~      The investigators hypothesize that nitroglycerin will reduce and inhibit uterine contractions~     in both oxytocin pre-treated myometrium, as well as untreated myometrium in a dose dependent~     fashion, but that myometrium that has undergone OTR desensitization will require less~     nitroglycerin for contractions to abate.~      The investigators also expect that the dose of oxytocin required to re-establish equivalent~     contractions will be higher in the myometrial samples which have undergone nitroglycerin~     mediated relaxation.~   "
12130|NCT03408041|"~     The early diagnosis of Alzheimer's disease is essential to enable patients to have access to~     the available treatments. However, there is a delay between the diagnosis and the onset of~     symptoms, which can range from 1 year to more than 5 years. In clinical practice, the~     hippocampal volume, measured by the Scheltens index, is currently used as a marker of the~     progression of the disease.~      The purpose of this study is to determine whether the patient's sex, age and ethnicity can~     influence the delay in the expression of cognitive troubles reported by the family at the~     first medical consultation, as well as to determine if there is a correlation between the~     delay reported by the family and the Scheltens index.~   "
12131|NCT03408028|"~     The diagnostic and therapeutic progresses, associated with modifications in lifestyle and~     socio-cultural level of populations, have led to a remarkable increase in life expectancy. At~     the same time, the increasing medicalization of the individual has eroded the traditional~     boundaries between health and illness, normal and pathological state. This leads to the~     patient losing his sense of ownership of his own death. If most patients died at home before~     the Second World War, 75% of the population dies in hospital or institution at the present~     date.~      Most hospitals and care institutions have developed codes, in multidisciplinary internal~     consultation, to address the interruption or lack of implementation of treatments that make~     no sense from a medical point of vue. This avoids therapeutic relentlessness.The code in~     place within the CHU Brugmann is:~        -  code A: no therapeutic restriction~        -  code B: not to be resuscitated~        -  code C: not to be intensively treated (no escalation in therapeutic treatments)~        -  code D: best palliative care (progressive de-escalation in therapeutic treatments).~      These codes are established in consultation with the patient or his legal representative and~     are re-evaluated in a multidisciplinary way every week.~      Planning a care path and therefore establishing a therapeutic code is particularly important~     for people with cognitive impairment and dementia because the progressive loss of cognitive~     abilities complicates the process of decision making.~      A large part of the admissions are made via the emergency department. For these patients, no~     therapeutic plan has been established beforehand. However, the perception of the functional~     and cognitive status of the patient directly influences the intensity of care provided.~     Cognitive disorders are a risk factor for the exclusion of access to palliative care for the~     elderly patient.~      The objectives of this study are:~        -  To establish a record of the therapeutic limitation codes in an acute cognitive~          geriatric unit~        -  To correlate the therapeutic limitation code with the comorbidities of the patients~   "
12132|NCT03408015|"~     Every night during sleep, there is an accumulation of white blood cells in the closed eye.~     The closed eye white blood cells are predominantly neutrophils, but there is a small~     population (3%) of T cells. The effects of these closed eye white blood cells on dry eye~     disease pathogenesis have yet to be fully elucidated, but preliminary evidence suggests that~     closed eye neutrophils may have an associated hyperactivity and increased degranulation in~     dry eye disease that could contribute to epithelial instability. As an anti-T cell therapy,~     Xiidra offers an opportunity to better understand how the closed eye white blood cells are~     recruited and activated. This study also seeks to verify the proposed mechanism of action.~   "
12133|NCT03408002|"~     The study aims to verify if a short individual psychological intervention might increase~     perceived self-efficacy in managing preoperative anxiety in patients who will undergo~     pancreatic surgery. It is a randomized clinical trial where half of participants will attend~     a psychological intervention based on the four elements protocol by Elan Shapiro the day~     before surgery, while the other half will follow usual care.~   "
12134|NCT03407989|"~     With our SWIDINEP cohort, we propose to explore the relationship between vascular risk~     markers and renal function decline in CKD stage 1-5. In order to realize these goals, we~     intend to recruit 200 patients within a 7y recruitment period (2014-2021). Recruitment is~     done in the nephrology and diabetes ambulatory clinics in the CHUV at Lausanne. Each eligible~     patient is identified and whether he/she can be proposed the study is discussed with the~     physician in charge of the patient. Once the patient is informed and has signed the consent~     form, he/she is examined in the Service of Nephrology at baseline, 2y and 5y.~   "
12135|NCT03407976|"~     This is an open label nonrandomized Phase I/ IIA trial designed to assess the safety,~     tolerability, and efficacy of apatinib in combination with pembrolizumab. Phase I will assess~     the safety of combining increasing oral daily doses of apatinib with a fixed dose of IV~     pembrolizumab every three weeks and will determine the RP2D (Recommended Phase 2 Dose). Phase~     II will assess the efficacy of the RP2D of apatinib in combination with pembrolizumab and~     provide additional safety and tolerability data in three disease-specific cohorts~   "
12136|NCT03407963|"~     The authors hypothesize that, in patients with low volume tumors identified according to~     anatomo-pathological criteria and imaging, and under active surveillance focal, therapy by~     unilateral embolization of prostatic arteries will provide local control of the tumor via~     selective ischemia~   "
12137|NCT03407950|"~     Schizophrenia is a chronic disease with deficit in social interaction and lost of autonomy in~     daily life. Negative symptoms as blunted affect, avolition, social deficit and anhedonia and~     cognition were prognosis and functioning key's factors. Psychotropic medications have shown~     only poor effect to improve negative symptoms and cognition as attention, memory and~     cognitive flexibility. So, cognitive remediation programs were developped to focus cognitive~     disorders. The IPT (Integrated Psychological Treatment) is one of the most complete program~     with modules on cognitive and social abilities. The aim of this study is to evaluate the~     efficacy of IPT+ program to improve autonomy capacities of long stay inpatients suffering~     from schizophrenia 6 at the end of the program With IPT+ this study will improve autonomy~     capacities for patients suffering from deficit schizophrenia and allowed patients to go out~     hospital earlier than before.~   "
12138|NCT03407937|"~     Introduction: Many interventions such as hypnosis, mindfulness meditation, conditioned pain~     modulation and placebos have been shown to effectively reduce pain both in the laboratory and~     in clinical settings. However, little is known about their neurophysiological mechanisms of~     action. Analgesia induced by these techniques is thought to be based on opioidergic and~     non-opioidergic mechanisms (potentially endocannabinoid mechanisms). Objective: Our main~     objective is to evaluate the effect of hypnosis, meditation, conditioned pain modulation and~     placebo on blood concentrations of endocannabinoids (anandamide, 2-arachidonylglycerol,~     N-palmitoyl-ethanolamine, N-oleoylethanolamide), endogenous opioids (β-endorphins, met /~     leu-enkephalins, and dynorphins) and norepinephrine in healthy adults. Methods: This study is~     based on a single-group pre-experimental research design in which two experimental sessions~     including hypnosis or meditation, conditioned pain modulation and placebo interventions will~     be completed by all participants. In order to have a better description of the~     sociodemographic and clinical characteristics of the sample, information will be collected by~     questionnaires or tests filled by participants at baseline, including: age, sex, language,~     culture, religion, salary, menstrual cycle of women, medication (if any), mood, anxiety, pain~     catastrophizing, mindfulness, hypnotic susceptibility, and DNA information. Outcome measures~     will be collected before, during and after each intervention. The primary outcome is plasma~     concentrations of endocannabinoids. Secondary measurements include plasma concentrations of~     endogenous opioids and norepinephrine; change in pain intensity during the thermal noxious~     stimuli; and autonomic nervous system variability (as measured by heart rate variability).~     Anticipated results: The investigators expect a positive relationship between the change in~     pain intensity (analgesia) induced by the interventions (hypnosis, meditation, conditioned~     pain modulation, and placebo) and the change (increase) in plasma concentrations of~     endocannabinoids, opioids, and norepinephrine in healthy adults. It is also believed that the~     interventions will influence heart rate variability. Moreover, it is expected that there will~     be a relationship between the efficiency of the analgesic intervention and some gene~     polymorphisms associated to pain modulation and endocannabinoids, opioids or norepinephrine~     in healthy individuals.~   "
12142|NCT03407885|"~     Bundled payments (BP) are a key part of Medicare's shift away from the traditional~     fee-for-service (FFS) payment model. The investigators propose to study a nationwide~     randomized-controlled trial (RCT) of bundled payments for knee and hip replacements that was~     designed and implemented by CMS and launched in April 2016. Randomization was conducted at~     the Metropolitan Statistical Area (MSA) level with 67 MSAs and about 800 hospitals assigned~     to the treatment group. The investigators will examine the impact of bundled payments on~     Medicare spending, utilization, and quality. Study findings should be directly relevant for~     the design of payments for knee and hip replacements, two common and expensive medical~     procedures. Average impacts, as well as variation in impact across types of providers and~     markets may also shed light on economic mechanisms, which should be relevant for bundled~     payment initiatives under consideration for other medical services.~   "
12143|NCT03407872|"~     The planned study is to determine the pharmacokinetic properties of Esketamine and safety~     assessment with inhaled Esketamine after different number of inhalations and different dosing~     sequences within three parts of the study.~   "
12144|NCT03407859|"~     CD19-negative B-ALL relapses after CD19 CAR T-cell treatment have occurred in some patients.~     CD20/CD22/CD10 is still expressed in CD19 negative B-ALL cells which means these CD molecules~     may become new targets in treatment of CD19-negative relapse of B-ALL. Thus sequential~     treatment with CD20/CD22/CD10-CART after CD19-CART treatment in relapsed/refractory B-ALL~     will kill and eliminate CD19 negative B-ALL cells and prolong the remission time.~   "
12145|NCT03407846|"~     100 patient will be recruited for hystrectomy for benign cause and TLH will be copared to TAH~     and effect of learning curve will be assessed by comparing operative time between early and~     lat patients in TLH group~   "
12146|NCT03407833|"~     The long-term goal is to understand the mechanisms of intestinal nutrient sensing and signal~     relays to insulin sensitive tissues (adipose, skeletal muscle, liver) in humans. The~     investigators hypothesize that human tissue biopsies (from obese surgery and non-surgery~     subjects as well as lean controls) can be used to understand the molecular mechanisms~     underlying intestinal nutrient sensing and signal relay in humans. The investigator will~     obtain tissue specimens from obese patients during scheduled upper endoscopies, colonoscopies~     and scheduled metabolic and bariatric surgeries. The investigator will obtain tissue~     specimens from lean patients during scheduled endoscopies and colonoscopies. A blood sample~     (4mL) will be obtained concurrent with these procedures. From metabolic and bariatric surgery~     subjects blood and tissues (liver, adipose, small intestine, omentum, skeletal muscle) will~     be collected at the time of surgery. Stool will be obtained preoperatively and at various~     time points after surgery.~   "
12147|NCT03407820|"~     This study aims to assess the relationship between overall satisfaction with treatment in a~     group of randomized patients undergoing elective hand surgery using either absorbable (4-0~     Chromic) or non-absorbable (5-0 Nylon) sutures. The investigators will also assess factors~     associated with wound concerns, pain intensity, magnitude of limitations, and physical~     function within one month of surgery.~   "
12148|NCT03407807|"~     The aim of this study was to describe prevalence, radiologic and ultrasound evolution during~     pregnancy, postnatal evolution and treatment strategy in case of isolated fetal spelnic cyst~   "
12149|NCT03407794|"~     Overweight and obese individuals seem to have an altered profile of the gut microflora~     compared to normal weight individuals. This proposal will examine whether daily consumption~     of fermented vegetables for 6 weeks can impact the gut microflora and markers of inflammation~     of overweight and obese women.~   "
12150|NCT03407781|"~     This is an open-label positron emission tomography/near infrared (PET/NIRF) study to~     investigate the imaging navigation performance and evaluation efficacy of dual modality~     imaging probe 68Ga-BBN-IRDye800CW in patients with lower grade glioma. A single dose of~     40μg/111-148 Mega-Becquerel (MBq) 68Ga-NOTA-BBN and 1.0- or 2.0- mg/ml IRDye800CW-BBN will be~     injected intravenously before the operation and intraoperative respectively. Visual and~     semiquantitative method will be used to assess the PET images and real-time margins~     localization for surgical navigation.~   "
12151|NCT03407768|"~     Although combination endocrine therapy has been associated with significant reduction in risk~     of recurrence in younger women with hormone receptor positive breast cancer, it has been~     associated with more adverse effects and decline in quality of life (QOL). Various behavioral~     and complementary interventions can be effective in reducing treatment-related side effects.~     The study aims to evaluate if individually-tailored behavioral and complementary~     interventions could improve treatment tolerance and adherence in women with early stage~     breast cancer. This benefit will be assessed primarily by change in QOL and secondarily by~     adherence to adjuvant endocrine treatment.~   "
12152|NCT03407755|"~     This blinded, randomized study compares the use of air and sulfur hexaflouride (SF6)~     tamponade in Descemet Membrane Endothelial Keratoplasty.~   "
12153|NCT03407742|"~     The proposed specific aims of this K01 pilot study were:~        1. Develop a culturally adapted and web-enhanced version of the Parent Management~          Training-the Oregon model (GenerationPMTO) intervention for first generation Hispanic~          families with youth.~        2. Implement a small randomized controlled trial (RCT) with the culturally adapted and~          web-enhanced version of the GenerationPMTO intervention.~        3. Systematically examine the implementation feasibility (i.e., rates of engagement,~          retention, and cultural acceptability) and initial efficacy of the adapted intervention~          (i.e., reduced parental stress and depression, increased quality of parenting skills,~          reduced levels of internalizing and externalizing behaviors in youth, and reduced~          adolescent substance use likelihood).~   "
12154|NCT03407729|"~     This observational study will investigate whether differences in birth events and oxygen~     levels during the newborn period affects the brain activity of children during the middle~     childhood years.~   "
12155|NCT03407716|"~     This randomized pilot trial studies how well North American ginseng extract AFX-2 (ginseng)~     works in decreasing cancer-related fatigue after treatment in cancer survivors. Ginseng may~     decrease fatigue in people who were treated for cancer.~   "
12156|NCT03407703|"~     The purpose of this study is to learn how 12 weeks of HCV treatment with elbasvir and~     grazoprevir (brand name Zepatier) impacts your kidney function.~   "
14555|NCT03376412|"~     The objective of this study is to evaluate the Raindrop® Near Vision Inlay for the~     improvement of near vision in presbyopes implanted under a corneal flap or within a~     small-incision pocket.~   "
12157|NCT03407690|"~     Since the introduction of pneumococcal conjugate vaccines, this research group has conducted~     several carriage studies. These were at key points in the evolution of the pneumococcal~     immunisation schedule, with regard to the introduction of PCV7, the change to PCV13 and the~     impending change in number of doses of PCV13 given to infants. The last carriage study,~     conducted in 2015/16 identified interesting changes in carriage patterns which will further~     be explored by the current planned study.~      Nasopharyngeal swabs and saliva swabs will be taken from healthy subjects and any pneumococci~     present will be cultured and serotyped using standard methods, as per our previous studies~     (Hussain et al., 2005; Flasche et al., 2011; van Hoek et al., 2014).~   "
12158|NCT03407677|"~     The ROTO track® is an electronic injection form and injection log for keeping track of~     injection sites in the abdominal region. The device attaches directly to the insulin pen and~     activates whenever the insulin pen is picked up. Small LED lights on the device will indicate~     where the next injection site is according to the individual patient's injection plan. By~     moving the pen and device to an anchor point in front of the navel, the device is able to~     start tracking where the insulin pen is being moved to. The device additionally contains a~     haptic interface to indicate to the user when the device has been moved to the next area in~     the injection plan.~      The device registers the location, the time and the dosage automatically when the patient~     injects insulin with the pen~      The rationale of the trial is that the ROTO track® can help patients rotate their injections~     sites and that this will provide the healthcare system with a new cost-effective tool for~     improving insulin injection techniques.~   "
12159|NCT03407664|"~     An abdominal aortic aneurysm (AAA) is a dilation of the aorta, defined as an aortic diameter~     of ≥3cm. It is a significant cause of death internationally and in England each year causes~     c.4,000 deaths with 8,000 patients undergoing preventative surgery. AAA are often~     asymptomatic and there is a latent period between development and rupture. This represents an~     opportunity to screen by ultrasound which has been shown in trials to reduce AAA related~     mortality by half.~      In England this evidence is based on a randomised trial data from the late nineties, however,~     since these data were published the number of men identified with AAA has fallen to a current~     prevalence of just over 1%. Furthermore, similarly designed randomised trials in Western~     Australia demonstrated no meaningful differences in AAA or cardiovascular deaths. The first~     aim of our research is to follow men who have been screened for AAA in England in order to~     establish the medium (5 years) and long term (10+ years) impact of AAA screening on the risk~     of a AAA, cardiovascular and all-cause morbidity/mortality in a non-trial setting. Men with~     sub-aneurysms will be examined (Aorta=2.5-2.9cm) as several studies suggest this group is at~     risk of late rupture.~      The role of patient pathways to improve uptake of the screening programme will be examined.~     Current data suggests that the most 'deprived' men in England are the least likely to turn up~     for screening but the most likely to have an abdominal aneurysm. Outcomes in this group will~     be analysed including the benefit of a new patient pathway to improve uptake nationally.~      Lastly, several large studies have demonstrated that a larger aortic diameter may be~     associated with cardiovascular risk. The addition of aortic diameter to current risk~     prediction models could improve the accuracy of these models and will be examined.~   "
12160|NCT03407651|"~     Phase 2, multi-center, open-label study designed to evaluate the PK, bioavailability, PD,~     efficacy and safety of a daily subcutaneous [SC] treatment regimen with MarzAA for bleeding~     prophylaxis in 12 adult subjects with hemophilia A or B with an inhibitor and history of~     frequent spontaneous bleeding episodes.~   "
12161|NCT03407638|"~     Effective treatment for opioid use disorders (OUDs) requires medications. Two medications for~     treating OUDs—buprenorphine and injectable naltrexone—can be prescribed in primary care (PC).~     However, despite the current opioid epidemic and expert recommendations that OUDs should be~     treated in PC, most PC clinics do not offer treatment for OUDs. This reflects a lack of~     consensus among health system leaders and clinicians that OUDs should be treated in PC.~      The PRimary care Opioid Use Disorders treatment (PROUD) Trial is a pragmatic~     cluster-randomized, quality improvement trial that evaluates implementation of a team-based~     approach to PC supported by a full time nurse (the PROUD intervention). This type of~     team-based PC is often referred to as collaborative care for management of OUDs in PC, and~     this type of trial is often referred to as a Hybrid Type III implementation trial.~      The trial is being conducted in 6 diverse health systems spanning 5 states (New York,~     Florida, Michigan, Texas, and Washington), with 2 PC clinics in each system randomized. One~     clinic is randomly selected to implement the PROUD intervention and the other continues usual~     PC (UPC).~      The overall objective of the PROUD trial is to provide information to guide health system~     leaders who are faced with the decision of whether or not to treat OUDs in PC, by evaluating~     the benefits of implementing the PROUD intervention that integrates high quality OUD~     treatment (i.e. buprenorphine or injectable naltrexone) into the normal flow of PC.~      The primary objective of the PROUD trial is to evaluate whether the PROUD intervention~     increases OUD treatment with buprenorphine or injectable naltrexone, documented in the~     electronic health records (EHRs) of PC patients, over a 2 year follow-up, as compared to UPC.~      The primary hypothesis is that there will be a significant increase in the number of~     patient-days of medication treatment for OUDs documented in the EHR of PC patients in the 2~     years after clinics are randomized to the PROUD intervention compared to PC clinics~     randomized to UPC. This implementation objective reflects whether the PROUD intervention~     increases initiation of and/or retention in OUD treatment, documented in EHRs within medical~     settings.~      The main secondary objective is to test the hypothesis that PC patients with OUDs documented~     in their EHRs in the 3 years prior to randomization who receive care in PROUD intervention~     clinics, compared to those who receive care in UPC clinics, will have fewer days of acute~     care utilization (including urgent care, emergency department [ED] and hospital care) in the~     2 years after randomization. This effectiveness objective assesses whether implementation of~     the MA Model improves patient outcomes.~   "
12162|NCT03407625|"~     Induction of labor is associated with increased cesarean delivery rates, particularly in~     women with an unfavorable cervix. Both pharmacologic and mechanical methods are utilized for~     cervical ripening and labor induction. Evidence on the safety and effectiveness of various~     mechanical and pharmacologic methods of cervical ripening and labor induction is abundant,~     and yet the majority of clinical trials evaluate time to delivery, rather than mode of~     delivery. This is a prospective, cluster-randomized clinical trial to compare a standard~     method of induction at our institution (oral misoprostol) with an alternative, commonly used~     combination method of oral misoprostol and transcervical foley bulb in women with term~     pregnancies requiring induction of labor.~   "
12163|NCT03407612|"~     The purpose of this study is to measure whether CPM (continuous passive motion) usage~     improves outcomes following arthroscopic hip surgery that includes labral repair.~     Investigators tested the hypothesis that CPM usage reduces pain levels and pain medication~     use and improves function in individuals who undergo hip arthroscopy.~   "
12164|NCT03407599|"~     The study is done to compare how faster aspart is taken up, broken down and removed from the~     body between different age groups (children [6-11 years], adolescents [12-17 years] and~     adults [18-64 years]) who have diabetes. The blood sugar (glucose) lowering effect of faster~     aspart will also be investigated after consuming a meal replacement drink. The effects of~     faster aspart will be compared to the effects of NovoRapid®.~   "
12197|NCT03407157|"~     This is a double-blind randomized placebo controlled trial that will investigate whether the~     use of three specific species of probiotics taken orally in pregnancy from 25 weeks gestation~     will reduce the incidence of Group B Streptococcus (GBS) colonization. Participants will take~     2 capsules and 1 lozenge per day of either probiotic or placebo from 25 weeks gestation. The~     primary outcome will be the result of their routine vaginal/rectal GBS swab collected after~     35 weeks gestation and before delivery. A reduction in women testing positive for GBS would~     lead to a decrease risk to infants of GBS infection and a reduction in the use of antibiotics~     leading to less maternal and neonatal antibiotic exposure.~   "
12165|NCT03407586|"~     The goal of this prospective cohort study is to determine if a model of care including~     point-of-care testing, immediate therapy, expedited partner therapy and test of cure will~     result in a higher cure rate and a lower recurrence rate of sexually transmitted infections~     (STIs), with a subsequent reduction in genital inflammatory cytokines and hence HIV risk~     among young women in a high burden setting in KwaZulu-Natal, South Africa. The study will~     identify individuals with STIs using the GeneXpert system for the simultaneous detection of~     Neisseria gonorrhoeae and Chlamydia trachomatis, and Trichomonas vaginalis. Genital tract~     cytokines will be measured using Bio-Plex Pro Human Cytokine kits and a Bio-Plex MagPix Array~     Reader. Following point-of-care diagnosis, participants will be treated immediately with~     appropriate therapy under direct supervision, offering the participants expedited partner~     therapy for their partners. STI testing and cytokine assessments will be repeated after 6 and~     12 weeks, to determine if these have decreased. Overall, this study will provide some~     evidence on whether this STI care model can have an impact on STI prevalence and genital~     tract inflammation, in a low- and middle-income country, where currently syndromic STI~     management is the standard of care.~   "
12166|NCT03407573|"~     The investigator wishes to see if it is possible to undertake a study comparing blood~     transfusion at two different levels of anaemia to see which is best for patients. All~     patients that present to hospital with a broken hip will be able to take part in the study.~     If they become anaemic during their treatment they will be allocated to either be transfused~     when their blood count is less that 9 or less than 7. In all patients, we will measure heart~     damage with a blood test that is very sensitive. The investigator will also collect data on~     the incidence of heart attacks and other complications.~   "
12167|NCT03407560|"~     This pilot study is to evaluate the potential effectiveness of bone substitute SintLife~     within the spinal surgery in spinal stabilization applications for degenerative diseases.~      In particular, the investigators propose to evaluate:~        -  the ability of bone regeneration/ fusion, defined as the presence of trabecular bone~          continuous bridge and absence of radiolucent lines, verified by diagnostic imaging in~          accordance with the Brantigan scale;~        -  the patient's state of health, evaluated through the comparison of the~          functional-symptom pattern between the pre- and post-operative phases, verified by~          Oswestry Disability Index (ODI), Visual Analogue Scale (VAS) and EuroQol (EQ-5D);~        -  the safety of the medical device, evaluated through the impact of any adverse events,~          complications, unexpected reactions, accidents.~      STUDY DESIGN This collection of clinical data is set up as pilot study post-marketing. In the~     study will be included all consecutive patients who require spinal fusion surgery, in~     accordance with the inclusion and exclusion criteria after signing the informed consent.~     Patients will be treated and followed postoperatively according to the normal clinical,~     surgical and therapeutic practice, in place at the Rizzoli Orthopaedic Institute of Bologna.~      The total duration of data collection is 36 months:~        -  the stage of patient enrollment is 18 months from the date of approval of the study by~          the Ethics Committee of the center;~        -  the phase of post-operative monitoring is 18 months, with planned at 6, 12 and 18 months~          follow-up (± 15 days before scheduled date).~   "
12168|NCT03407547|"~     This clinical study is organized for people with stroke often experience difficulties with~     their sensation in their upper limb. New technologies may be able to help these important~     problems. However, there is currently not enough knowledge about how the brain recovers in~     people with sensory impairments in their arm and hand. Using a non-invasive technique of~     recording brain activity, known as electroencephalography (EEG), brain activity in~     combination with somatosensation of the hand will be measured. Therefore, the purpose of this~     study will be to analyse brain activity in relation to somatosensory impairments after stroke~     during the first two weeks after stroke.~   "
12169|NCT03407534|"~     The prevalence of exocrine pancreatic insufficiency (EPI) among patients presenting with~     diarrhea and bloating as their chief complaints is not well studied. Diarrhea and or bloating~     can be due to different etiologies such as celiac disease and irritable bowel syndrome.~     However, concomitant EPI can exacerbate these conditions, or be the main cause of the~     symptoms. Furthermore, some of these diagnoses can be epiphenomena or consequences of EPI.~     The Investigators hypothesize that EPI will be detected in significant proportion of patients~     with bloating or diarrhea and that early detection and management of EPI can prevent~     unnecessary work up for other causes of diarrhea.~   "
12170|NCT03407521|"~     the investigators aimed to study the efficacy and safety of nitric oxide donors when combined~     with prostaglandins in induction of second trimester abortion expecting that both drugs when~     used together will be of greater efficiency and associated with less side effects.~      the study included 60 women with gestational age between 13weeks+0day and 26weeks+6days~     indicated for pregnancy termination due to maternal or fetal cause.~   "
12171|NCT03407508|"~     There is a significant and growing interest in nutrition and health in the general population~     and there is also, paradoxically, an increasing problem with obesity and general debilitating~     conditions of affluence, such as type 2 diabetes mellitus. Igelösa Life Science AB has~     developed a modified Okinawan-based Nordic Diet (OBND) diet based on evidence primarily from~     the diet of the long-lived and healthy Okinawa population. The diet includes fish and whole~     grains, with a high level of vegetables, but is low in fat. In 2016, a clinical nutrition~     study was carried out at Kristianstad University with the intention to determine if the OBND~     resulted in reductions/changes in clinical and medical markers of importance for treatment of~     diabetes mellitus and gingivitis/periodontitis. The diet had a positive impact on the~     clinical progress of otherwise debilitating conditions such as diabetes and the health~     benefits on clinical parameters was extremely rapid, that is, within two weeks. Not only did~     the patients with type 2 diabetes receive the OBND, their partners were also offered the same~     option. This is a key innovation and the participants stated that it was a great support,~     which facilitated adherence and promotes the long-term impact on health. Ingrained habits~     such as poor diet, can only be defeated by a concerted team effort and our work to date~     provides a glimpse of the potential benefits to Sweden and the rest of the developed world~     through this shared approach.~      Initial studies have shown promising effects of the OBND on both diabetes and periodontal~     conditions. The objective of this study is to compare the OBND to the current recommended~     standard diet. Assuming the study provides positive evidence of health impact due to improved~     food quality, it will also be seen that the production and delivery of such 'healthy-living'~     meals will be of commercial interest for industry. The mission is to offer an evidence-based~     natural food alternative that both prevents disease and improves the health status of~     individuals with diabetes. The long-term goal is to design efficient and effective products~     that will protect against diabetes and other chronic diseases. The combination of scientific~     credibility and commercial interests may be a key factor to transfer the new knowledge about~     healthy dieting into actual improvements in public health.~   "
12172|NCT03407495|"~     This study is an exploratory study aiming to collect data on sensitivity and positive~     predictive value of IOP-enhanced MRI compared to dynamic multiphase MDCT for the detection of~     HCC.~   "
12175|NCT03407456|"~     The diagnosis of gastro-oesophageal reflux disease (GORD) is often based on 24-hour~     catheter-based pH studies. The Bravo™ wireless pH monitoring revolutionised the study of~     GORD, allowing patients an improved comfort and ability to perform activities of daily~     living. The backflow of gastric acid (acid exposure) in the oesophagus is monitored by a tiny~     pH sensor located in a capsule which is pinned temporarily to the wall of the oesophagus at~     the time of endoscopy. Normal measurements (also called parameters) for acid exposure are~     established for 48-hour studies. However, our studies have shown that extending the duration~     of recording to 96 hours further improved the diagnostic yield for GORD in patients with~     negative 24-hour catheter-based tests. While pathologic acid exposure and symptom-reflux~     association in catheter-based pH studies anticipate a successful outcome after anti-reflux~     surgery, the clinical relevance of increasing the duration of recording is lacking. This~     study aims to investigate the relationship between the result of participants Bravo test and~     their symptoms on their usual medication.~      This is a single centre, prospective, observational study enrolling males and non-pregnant~     females over the age of 18 years with gastro-oesophageal symptoms in accordance with Montreal~     criteria and who have clinical indications for Bravo™. The study is based on questionnaires.~     All clinical interventions, including 96-hour Bravo™ pH monitoring, temporary cessation of~     medication and outpatient clinic follow-up is offered as routine medical care, regardless of~     their participation in the study.~      Patients will be contacted over the phone ten days before the procedure by a member of the~     research team involved in their clinical care and asked whether they would be interested in~     joining the study.~      Participants will complete a baseline 7-day recall Reflux Symptom Questionnaire (RESQ-7)~     before having Bravo™ for 96 hours. Participants will have a telephone follow-up at 4 weeks~     and 8 weeks to assess their symptoms based on the RESQ-7 questionnaire.~      We anticipate the recruitment of 100 subjects over 6 months. The final endpoints will be~     achieved 6 months after the last patient has been interviewed.~   "
12176|NCT03407443|"~     This pilot study seeks to determine if exposure to the Make the Connection campaign messages~     developed by the U.S. Department of Veterans Affairs (VA) is associated with changes in~     mental-health related outcomes, specifically: (1) psychosocial determinants that drive help~     seeking behaviors (knowledge, attitudes and intentions); and (2) perceived barriers to~     seeking care. Participants are randomly assigned to message exposure or control (no exposure)~     conditions. Data from this project will inform mental health education and outreach efforts~     targeted towards Veterans experiencing mental health concerns.~   "
12177|NCT03407430|"~     Purpose:~      To evaluate the preventative effects of pregabalin on pegfilgrastim-induced bone pain in~     cycle 1. Because granulocyte colony stimulating factor (G-CSF) receptors are found at nerve~     endings which modulate the pain signal, blocking this with pregabalin is theorized to prevent~     the occurrence of this adverse effect.~      Participants:~      Patients will be at least 18 years of age with either a diagnosis of a non-myeloid~     hematologic malignancy scheduled to initiate a cycle of chemotherapy that requires~     prophylactic use of a G-CSF, or with a diagnosis of breast cancer scheduled to initiate~     dose-dense doxorubicin/cyclophosphamide chemotherapy or docetaxel/cyclophosphamide that~     requires prophylactic use of a G-CSF.~      Procedures (methods):~      This is a randomized (1:1), single center, placebo-controlled, double blind, crossover phase~     II study. The primary objective is to compare the proportion of patients who have an increase~     in pain score of ≥3 from baseline in cycle 1 between Arm A (pregabalin) and Arm B (placebo).~     In consultation with the treating physician, the PI will determine what day pegfilgrastim~     will be initiated in each eligible, consented patient. Pregabalin or placebo will begin 4~     days prior to pegfilgrastim administration, and continue for 7 additional days starting the~     day of pegfilgrastim administration.~   "
12178|NCT03407417|"~     The purpose of this proposal is to test the efficacy of a patient-centered, tailored message~     intervention delivered via virtual technology for increasing colorectal cancer (CRC)~     screening within guidelines among racial/ethnic minority and rural patients. This protocol~     focuses on the clinical portion of grant NCI 1RCA207689-01A1~   "
12179|NCT03407404|"~     A prospective, double-blinded, multicenter randomized control trial. All critically ill~     patients above 12 years of age requiring continuous sedation for >24hrs in the ICU will be~     screened and those meeting selection criteria (and consented) will be enrolled into the~     study.~   "
12180|NCT03407391|"~     Picky eating behaviour in young children is a very common concern for parents. The aim of the~     study is to investigate factors during early life which are associated with a child becoming~     a picky eater.~   "
12181|NCT03407378|"~     The purpose of this clinical trial conducted in patients with Parkinson's Disease is to study~     the relationship between patient individual profile and their response to IPT803 Adjunct~     Treatment (treatment response being characterized by movements improvement).~   "
12182|NCT03407365|"~     The purpose of this study is to determine if a 10 week exercise rehabilitation program~     decreases anterior knee oain (PFPS) and improves function in patients with patellofemoral~     pain syndrome (PFPS). Individuals (age 18-50) with PFPS will be recruited to participate in~     this study to see if a 10 week exercise program focusing in core and hip strengthening, lower~     extremity strengthening foot intrinsic strengthening can decrease pain and increase function.~   "
12183|NCT03407352|"~     Response inhibition is a cognitive process that helps individuals suppress or avoid unwanted~     actions and inappropriate behavior. In regards to food, response inhibition allows a person~     to resist eating, ignore poor food choices and poor behavior related to food choices.~     Previous research suggests that physical activity may play a role in the regulation of~     response inhibition to food in adults.~      The purpose of this study is to compare the effects of an acute bout of active video gaming~     versus passive video gaming on response inhibition to high calorie and low calorie food~     images among adolescents.~      The proposed study is a randomized cross-over study with counterbalanced design. Participants~     will come to the lab two times. Each subject will serve as their own control. There will be~     two conditions and all participants will complete both conditions. One condition will be~     completed each time the participants come to the lab. The two conditions will include (a) 60~     minutes of sedentary video game play and (b) 60 minutes of active video game play at~     moderate-intense levels. After each video game condition the participants will view pictures~     of high-calorie and low-calorie foods while being connected to an EEG machine. The EEG will~     measure the N2 and P3 event-related potentials, which will be used to index and analyze~     response inhibition. As participants view the pictures of high-calorie and low-calorie foods,~     they will be given a button pressing task where the press a button when they see pictures of~     the high-calorie or low-calorie foods. Immediately after each video game session participants~     will complete two cognitive measurement tasks. These tasks are (a) Stroop color-word task and~     (b) auditory verbal learning test. The Stroop color-word test requires the participants to~     read words typed in different colors on a sheet of paper and to say the name of the color of~     ink the words are printed in (ie to say blue when the word red is printed in blue ink).~     The auditory verbal learning test will require the researchers to read a list of 15 words and~     have participants repeat as many of the words back to the researcher as possible. This will~     be repeated 6 times. After the 5th time, there will be a 30 minute waiting period before the~     6th trial where participants will be allowed to eat ad libitum pre-weighed foods while they~     wait to complete the last trial of the verbal learning test.~   "
12198|NCT03407144|"~     This study will examine the safety and efficacy of pembrolizumab (MK-3475) in combination~     with chemotherapy in children and young adults with newly diagnosed classical Hodgkin~     Lymphoma (cHL) who are slow early responders (SERs) to frontline chemotherapy.~   "
12199|NCT03407131|"~     To evaluate the efficacy and safety of internal fixation or arthroplasty for hip fracture~     patients over 75 years of age with multiple medical complications through the operation time,~     intraoperative bleeding, time to start weight bearing activities and other indicators.~   "
12184|NCT03407339|"~     Background:~      Nationally and internationally, more people over the age of 65 and especially an increase of~     people over the age of 80 enter nursing homes with natural dentition and complex prostheses~     and bridges than previous generations. Furthermore, there is an increased incidence of dental~     diseases in the elderly. This is leading to increased and different oral care needs. There is~     a large discrepancy between the elderly who need help with oral hygiene and the elderly who~     actually receive help. In order to improve the oral hygiene competencies of healthcare~     professionals at nursing homes, it is necessary to increase their education and improve~     organizational strategies.~      Hypothesis:~      The Intervention Shared Oral Care improves the elderlys bleeding and plaque index after 6~     months.~      Study type:~      An intervention study.~      A cluster randomization of 14 nursing homes in Aalborg municipality is carried out.~      Outcome Measures:~      Change in mucosal-plaque score (MPS) index~      Change in Oral Related Quality of life~      Outcome Measure Time Frame:~      Change in mucosal-plaque score index measured at 0, 3 and 6 months.~      Change in Oral Related Quality of life measured at 0 and 6 months.~   "
12185|NCT03407326|"~     In this clinical equivalency trial, two foods will be compared for the treatment of SAM,~     testing the hypothesis that the difference in recovery rates and growth between the two test~     groups will be no greater than 5 percent.~   "
12186|NCT03407313|"~     This study will evaluate the safety and efficacy of rotational fractional resection (RFR) to~     improve neck contouring. RFR is used to remove loose skin and fat.~   "
12187|NCT03407300|"~     This is a prospective, randomized, multicenter clinical study designed to evaluate its safety~     and efficacy by using Docetaxel with or without Traditional Chinese Medicine XH1 in patients~     with Stage ⅢB-Ⅳ Non-small Cell Lung Cancer (NSCLC) who failed with first-line Chemotherapy.~     The primary outcome measure includes progression-free survival (PFS) after treatment.~     Secondary outcome measures include collecting biomarkers before and during treatment, overall~     survival (OS), objective response rate (ORR), disease control rate (DCR), and patient's~     quality of life.~   "
12188|NCT03407287|"~     The aim of this study is to determine the effects of fluid alternations, hemodynamic changes,~     mechanical ventilation, pharmacologic agents, positional changes, and comorbidities on the~     Peripheral Intravenous waveform Analysis (PIVA) signal.~   "
12189|NCT03407261|"~     OHRQoL assessment using OHIP-14 between sliding anterior retraction with self-ligating~     brackets and micro-osteoperforations for accelerated orthodontics in orthognathic surgery~     patients who were assigned for pre-molar extraction and decompensation~   "
12190|NCT03407248|"~     This is a secondary analysis of dietary, demographic and health parameter data collected in~     the 2008/09-2011/12 National Diet and Nutrition Survey (NDNS), UK to determine the roles of~     dairy products in sustainable diets by modelling nutritional adequacy, financial cost and~     environmental impact of UK diets containing varying amounts of dairy products.~   "
12191|NCT03407235|"~     Comparison of laparoscopic training simulator v use of eye patch (to simulate loss of dept~     perception) to investigate acquisition of laparoscopic skills.~   "
12192|NCT03407222|"~     In this study, investigators measured the number of steps, blood pressure, blood glucose, and~     weight in daily life through the smartphone personal health record application for patients~     with type 2 diabetes. The efficacy of text message intervention, which encourages an increase~     in the number of steps per week for 12 weeks, on an increase in the number of daily steps and~     changes in glucose levels, weight, and blood pressure will be investigated. Also, the~     durability of intevention will be checked after 12 weeks of intervention ending.~   "
12193|NCT03407209|"~     Epidural analgesia is a significant feature of the everyday experience of the delivery room.~     Its benefits on the maternal experience and in terms of security has been widely~     demonstrated.~      However, some women under epidural analgesia have experienced motor block, which has been~     found to contribute in the lengthening of the duration of labor, dystocia and instrumental~     delivery. Therefore, in recent years, reducing these side effects by modifying local~     anesthetics, concentration of local anesthetic and injected volume has been a priority, with~     one aim: optimize analgesia without motor blockage.~      Although epidural analgesia was first provided by continuous epidural infusion, the efficacy~     of intermittent epidural bolus has been demonstrated. Small regularly spaced intermittent~     boluses lead to a more extensive and symmetrical spread of local anesthetic in the epidural~     space. These findings have led to a new kind of administration combining epidural~     intermittent boluses with patient-controlled boluses called PEIB (Patient Epidural~     Intermittent Bolus). On clinical grounds, PEIB is associated with reduced local anesthetic~     consumption and higher maternal satisfaction.~      While PEIB is experimentally and clinically approved, incidence of maternal motor block and~     instrumental vaginal delivery don't decrease significantly with this programming. We~     hypothesized that automatic intermittent boluses can lead to an accumulation of local~     anesthetic overlapping with patient bolus. This accumulation can be the source of motor~     block, dystocia and instrumental delivery. Therefore, we propose to lead a monocentric~     prospective randomized study upon 308 patients in order to compare PEIB to epidural analgesia~     totally controlled by the patient. We expect a lower consumption of local anesthetic and a~     lower incidence of motor block, dystocia and instrumental delivery with the free automatic~     bolus programming.~   "
12194|NCT03407196|"~     Background/Rationale:~      Objectives and Hypotheses: To describe characteristics of patients with type 2 diabetes (T2D)~     prescribed dapagliflozin in routine internal medicine and endocrinology outpatient clinical~     care in Turkey; to describe changes in HbA1c(%), weight(kg), BMI(kg/m^2) and blood pressure~     (BP)(mmHg) in these patients; and the discontinuation rates of dapagliflozin in the first 6~     months of treatment.~      Methods:~      Study design: a retrospective observational cohort study. Data Source(s): Patient medical~     records of 81 different centres. Study Population: patients with a diagnosis of T2D, a first~     prescription for dapagliflozin, between July 2016 and Aug 2017 and who have been registered~     in the participating centre at least 6 months prior to first prescription of dapagliflozin.~      Study variables: patient characteristics: age, gender, smoking status, co-morbidities,~     duration of diabetes, prescribed medicines, HbA1c(%), weight(kg), body mass index~     (BMI)(kg/m^2) and blood pressure (BP)(mmHg).~      Outcome(s): description of patient characteristics, HbA1c(%), weight(kg), BMI(kg/m^2) and~     BP(mmHg) at baseline and during use of dapagliflozin at first visit (2,3 or 4 months) and~     second visit (5 or 6 months).~      Sample Size Estimations:1500 patients Statistical Analysis: the baseline characteristics and~     follow up variables will be described using frequency and percentage distributions for~     categorical variables. Continuous and count variables will be described using mean (±~     standard deviation), median (quartiles) and 95% confidence intervals. Proportion of patients~     falling above/below certain weight(kg)/BMI(kg/m^2), HbA1c(%) and BP(mmHg) thresholds will be~     derived. HbA1c(%), weight(kg), BMI(kg/m^2) and BP(mmHg) will be described at baseline and~     during use of dapagliflozin. Over all questionnaire response rate and rate of response to~     reasons for prescribing dapagliflozin will be described.~      Limitations: Variation in timing and completeness of clinical measures. The patient medical~     records are not collected for research purposes and the diagnostic and procedure coding on~     such data may be recorded incorrectly or not recorded at all, thereby potentially introducing~     measurement error with respect to code-based variables. The centres participating in the~     study, record that a prescription was issued, but not whether it was dispensed from the~     pharmacy.~   "
12195|NCT03407183|"~     To assess the efficacy of botulinum toxin in spastic neurogenic bladder.~   "
12196|NCT03407170|"~     In this study, participants with advanced melanoma will be treated with pembrolizumab~     (MK-3475) and their tumors and blood will be analyzed for changes related to pembrolizumab~     therapy.~   "
12207|NCT03407027|"~     This study has the primary goal of evaluating the efficacy of corticoid infiltration in the~     quadratus lumborum syndrome, aiming to determine if there are benefits with the use of~     corticosteroids and if they exist, if this improvement comes only from the systemic effects~     of corticosteroid administration.~   "
12200|NCT03407118|"~     This study will compare LY900014, a drug that lowers blood sugar, with insulin lispro~     (Humalog). Both drugs will be given by injection under the skin of the abdomen. This study~     will be conducted in participants with type 1 diabetes to investigate how quickly and how~     much LY900014 is absorbed and the effect of LY900014 on blood sugar levels in comparison with~     insulin lispro. The study will last about 3 to 6 weeks for each participant, not including~     screening.~   "
12201|NCT03407105|"~     The purpose of this study is to assess the safety and tolerability of 2 or 4 doses of MDX-010~     in HIV-infected subjects~   "
12202|NCT03407092|"~     This study aims to compare the efficacy and safety of ADAPT vs Stentriever techique in a~     multicenter stroke cohort of patients.~   "
12203|NCT03407079|"~     Background:~      Artificial sweeteners like sucralose are found in many foods and drinks. Sucralose might~     affect hormones and cause health changes.~      Objective:~      To see if sucralose changes how medicines are absorbed and processed, how hormones are~     secreted, gut bacteria, and how fat cells are metabolized.~      Eligibility:~      People ages 18-60 who:~        -  Are black or Hispanic~        -  Weigh more than 110 pounds~        -  Have a body mass index of 25-40~        -  Do not have a condition that requires drug treatment~      Design:~      Participants will be screened with:~        -  Medical history~        -  Physical exam~        -  Blood, heart, and urine tests~      Participants must not eat or drink anything with artificial sweeteners throughout the study.~      Over 7 days, Participants will answer questions, and give daily urine samples and 1 stool~     sample. Participants will repeat these throughout the study.~      Overnight Visit 1: participants will fast starting the night before. They will get breakfast~     at the visit. The visit includes:~        -  An IV will be placed in the arm. Participants will get 2 tablets of medicines. Blood~          will be drawn several times over 24 hours.~        -  A piece of fat tissue may be taken from the abdomen (biopsy).~        -  Participants will have a sweet drink. Blood samples will be taken over 2 hours.~      Then participants will be randomly assigned to take either a sucralose capsule or placebo.~     They will take it twice a day for 2 weeks. They will complete two 24-hour food diaries.~      Overnight Visit 2 repeats Visit 1 except the biopsy.~      Then participants will take the capsules for another 2 weeks.~      Overnight Visit 3 repeats Visit 1.~      Participants may be contacted by phone within 4 weeks after they finish.~   "
12204|NCT03407066|"~     Background:~      When people see and hear, the brain changes signals from the eyes and ears into perceptions~     and thoughts. No one fully understands how this happens. Researchers want to explore how~     healthy brains process sights and sounds.~      Objectives:~      To explore how people understand what they see and hear when the brain processes sights and~     sounds.~      Eligibility:~      Adults ages 18 65 who have at least 20/40 vision in at least one eye and do not use a hearing~     aid.~      Design:~      Some participants will take tests online anonymously. They will do computer tasks related to~     colors and behavior.~      In-person participants will be screened with medical history and physical exam. They will~     complete questionnaires and vision and hearing tests.~      Participants will plan how many testing sessions they will have and when. Sessions last 2 5~     hours. They may include:~      Magnetic Resonance Imaging: Magnets and radio waves to take pictures of the brain.~     Participants will lie on a table that slides in and out of a tube. They will do a task during~     the scan.~      Magnetoencephalography: Records magnetic field changes from brain activity. Participants will~     sit or lie down. A cone will be lowered onto their head. They may do a task during the test.~      Electromyography: Electrodes attached to the skin will measure the electrical activity of~     muscles.~      Electroencephalogram: Electrodes on the scalp will record brain waves.~      Electrocardiography: Electrodes on the chest will record heart electrical activity.~      Tests of memory, attention, thinking, vision, and hearing.~      Eye Tracking: Cameras will follow participants eye movements. They may wear a cap with~     infrared cameras in front of their eyes.~      During the sessions, participants vital signs may be monitored.~   "
12205|NCT03407053|"~     Background:~      Eating too much processed food is believed to lead to obesity. But the effect of processed~     food on energy intake has not been carefully studied. Researchers want to study people s~     diets for 4 weeks and do specialized tests of the effects. Participants will get two diets.~     They will have the same calories and nutrients, but one diet will be unprocessed food and the~     other will be ultra-processed.~      Objective:~      To better understand how processed and unprocessed foods affect daily food consumption and~     how the body handles blood sugar.~      Eligibility:~      Healthy adults ages 18-50 who have stable weight and can exercise~      Design:~      Participants will not eat for 12 hours. Then they will be screened with:~        -  Medical history~        -  Physical exam~        -  Heart and blood tests~        -  Resting energy expenditure test (REE). A hood will collect air exhaled while lying down~          for 30-40 minutes.~        -  Psychiatric questions~        -  Questions about mood, eating, sleep, and socioeconomic status~        -  20-minute stationary biking~      Female participants will have a urine pregnancy test.~      Participants will stay in the clinic for 4 weeks. For 2 weeks they will get a processed diet.~     For the other 2 weeks they will get an unprocessed diet. Participants cannot use the study~     period to gain or lose weight.~      Participants will have:~        -  Meals and snacks provided~        -  Daily exercise~        -  Blood, urine, and saliva tests~        -  To drink a special water and a very sweet liquid~        -  REE~        -  Scans and X-rays~        -  To wear activity monitors and a device to measure blood sugar~        -  Several 24-hour periods in a room that measures oxygen and carbon dioxide~        -  Repeats of screening questions~        -  Questions about hunger and meals~        -  Sleep monitoring~        -  Taste tests~   "
12206|NCT03407040|"~     Background:~      Researchers want to test if certain cells can be re-programmed into stem cells. Stem cells~     can keep reproducing for a long time. Cells made by stem cells can be turned into different~     types of cells. These include cancer-fighting cells, skin cells, etc. The stem cells~     generated in this study will be used to make specific tumor-fighting cells that can recognize~     different types of mutations in cancer cells. They may also help identify new tumor mutations~     that may not have been identified yet.~      Objectives:~      To test if a certain type of tumor-fighting cells can be re-programmed into stem cells.~      Eligibility:~      Participants in another Surgery Branch protocol who are at least 16 years old~      Design:~      Participants already gave samples of blood and/or tumor tissue in the other protocol. They do~     not need to come back to the clinic or give any other samples.~      Participants will give consent for their samples to be used in this study.~      Researchers will obtain cells from the samples. They will grow those cells in the lab. They~     will create stem cells from them.~      Researchers will do genetic tests on the samples.~      Most tests will not show important health results. But if they do, the participant will be~     invited to talk to a genetic counselor and get more detailed testing to confirm the results.~      Some of the samples and results will be stored indefinitely. They may be used in future~     research. No personal information will be stored with them.~   "
14556|NCT03376399|"~     The purpose of this registry is to evaluate if sleeve gastrectomy surgery will help with~     symptoms of delayed gastric emptying for patients suffering from diabetic gastroparesis.~   "
12208|NCT03407001|"~     The goal of this clinical research study is to find out if ultrasound scans using a contrast~     agent called Lumason (sulfur hexafluoride lipid-type A microspheres) can help doctors more~     easily find liver lesions (including hepatocellular carcinoma [HCC]), compared to ultrasounds~     without contrast agent. Contrast agents are drugs that are injected into a vein in order to~     help certain organs and tissues show up more clearly on scans.~      Researchers will also compare the effectiveness of liver ultrasounds using Lumason versus~     standard MRI imaging, in patients with cirrhosis of the liver.~      This is an investigational study. Ultrasound and MRI scans on this study are performed using~     FDA-approved and commercially available methods.~      Up to 150 patients will be enrolled on this research study. All will take part at MD~     Anderson.~   "
12209|NCT03406988|"~     A randomized controlled trial will be performed to confirm preliminary uncontrolled data~     indicating that regional adipose tissue grafting is effective in inducing digital ulcer~     healing in patients with systemic sclerosis.~      Systemic Sclerosis patients with digital ulcers will be randomized to be blindly treated with~     adipose tissue implantation or a sham procedure. Adipose tissue grafting will consist of~     injection at the base of the finger with digital ulcer of 0.5-1 ml of adipose tissue after~     centrifugation of fat aspirate. Sharm procedure will consist of false liposuction and local~     injection of saline solution.~      The primary end-point will be to compare the cumulative prevalence of healed digital ulcers~     in the two groups within the following 8 weeks.~   "
12210|NCT03406975|"~     Endoscopic Sleeve Gastroplasty (ESG) is an endoscopic minimally invasive weight loss~     procedure where a commercially available, FDA approved, full-thickness endoscopic suturing~     device (Overstitch; Apollo Endosurgery, Austin, TX) is used to reduce the stomach volume by~     80% through the creation of a restrictive endoscopic sleeve. This is accomplished by a series~     of endolumenally placed full-thickness sutures through the gastric wall, extending from the~     antrum to the gastroesophageal junction.~      Up to 200 participants at 8 locations in the United States will participate in this study.~      The ESG procedure has been performed clinically for 3 years in the United States. The~     investigators are completing this study to compare how effective the ESG is for achieving~     long-term weight loss when compared to lifestyle modification only, as well as to evaluate~     the long-term safety and durability of the procedure and its impact on quality of life.~     Results of this research may help support having this procedure covered by health insurance~     plans for future patients.~   "
12211|NCT03406962|"~     This study is designed to assess the safety and efficacy of using MGTA-456 in patients with~     Inherited Metabolic Disorders (IMD) undergoing stem cell transplantation.~   "
12212|NCT03406949|"~     The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics (PK)~     pharmacodynamics and preliminary antitumor activity of MGD009 administered in combination~     with MGA012 in patients with B7-H3- expressing tumors.~   "
12213|NCT03406936|"~     Daily interruption of sedation is one of the modalities which is known to enhance early~     weaning and separation from mechanical ventilation . Daily sedation interruption is also~     known to help decreasing incidence of ventilator associated pneumonia. The new modality is no~     sedation.~   "
12214|NCT03406923|"~     This study uses an intervention mixed methods design. The overall purpose is to improve~     medication adherence and assess the clinical impact on diabetes outcomes among patients with~     uncontrolled diabetes. We will examine if usual care combined with a clinic-based health~     literacy/psychosocial support intervention improves medication adherence compared to usual~     care alone. A randomized controlled trial will be conducted at William S. Middleton Memorial~     Veterans Hospital in Madison, targeting individuals with uncontrolled diabetes. The~     patient-centered health literacy intervention will focus on enhancing patients' self-efficacy~     and addressing patients' negative beliefs in medicine and illness.~   "
12215|NCT03406910|"~     This is a longitudinal study that will collect demographic, anthropometric and dietary data~     to determine the relationships between meat and egg intake and the incidence of Type 2~     Diabetes.~   "
12216|NCT03406897|"~     The investigator propose to test the safety and efficacy of a regimen that combines Omega-3~     Fatty Acids and Vitamin D in a design that considers timing and duration of administration in~     relation to their effects and predicted synergies.~   "
12217|NCT03406884|"~     Male or female neonates, < 28 days (inclusive) diagnosed with hypoplastic left heart syndrome~     (HLHS) undergoing Stage I surgery. A total of 30 patients will be enrolled for this pilot~     study in a staged enrollment diagnosed with HLHS.All patients will be followed for 12 months~     post-treatment.~   "
12218|NCT03406871|"~     the efficacy and safety ofhe use of regorafenib in combination with nivolumab~   "
12219|NCT03406858|"~     This phase II trial studies how well pembrolizumab and HER2Bi-armed activated T cells work in~     treating patients with castration resistant prostate cancer that has spread to other places~     in the body. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of~     tumor cells to grow and spread. HER2Bi-armed activated T cells are made using T cells and may~     target and kill cancer cells. Giving pembrolizumab and HER2Bi-armed activated T cells may~     work better in treating patients with castration resistant prostate cancer.~   "
12220|NCT03406845|"~     This pilot clinical trial examines the acceptability of meditation techniques versus health~     promotion in people receiving dialysis who have anxiety or depression. 50% of people who~     undergo dialysis experience anxiety or depression, but these conditions go undetected and~     untreated. Meditation and help promotion is helpful for anxiety and depression, but no one~     has compared the effects of meditation versus health promotion in people on dialysis~     specifically. Our aim is to evaluate whether meditation is more effective than health~     promotion.~      Nephrology doctors and nurses from collaborating hospitals in Montreal (MUHC) will help the~     recruit participants. The study will last 8 weeks, including a 6-month follow-up to measure~     depression and anxiety symptoms. Assessment will include pre-post evaluations about their~     depression and anxiety symptoms, overall health, sleep (Acti-watch), heart rate variability~     and blood draws (for inflammatory markers). A qualitative interview assessing participant~     experience will take place at program end.~      Participants will be randomly assigned. The participants will practice meditation or health~     promotion exercises with a trained interventionist in 20-minute sessions 3 times a week,~     during their dialysis sessions. Participants in the meditation group will learn mindfulness~     meditation exercises, whereas participants in the health promotion group will learn about~     healthy diet, music, exercise and positive health-enhancing life changes.~      Many people find meditation and health promotion enjoyable and relaxing. In the unlikely~     event people may have intense, but not dangerous reactions to meditation, the~     interventionists are trained to manage their reaction and direct them to appropriate care.~     Their hemodialysis treatment will not be affected by this study.~      It is hoped to improve mental health care for people on dialysis suffering from depression~     and anxiety. If this study shows that people in the meditation group greatly benefited than~     those participating in health promotion, investigators will create a bigger study to confirm~     whether it is truly effective for anxiety and depression in dialysis patients. Meditation may~     become a widely used treatment for people on dialysis with anxiety and depression, and~     investigators would train nephrology staff to make this treatment as accessible as possible.~   "
12221|NCT03406832|"~     Elective percutaneous coronary intervention (EPCI) is the common treatment of ST segment~     elevation myocardial infarction (STEMI).Slow flow / no-reflow phenomenon following EPCI in~     STEMI patients has been a serious and common complication that closely related to the~     incidence of major adverse cardiovascular events (MACE) and affected patients' prognosis. No~     reflow is a multi-factorial phenomenon. And its preventive and therapeutic effects are not~     satisfactory. This prospective randomized controlled study aimed to compare favorable effects~     of Nitroprusside versus Tirofiban on the prevention of slow flow / no-reflow phenomenon~     during EPCI.~   "
12222|NCT03406819|"~     Primary percutaneous coronary intervention (PPCI) is the gold standard of treatment of ST~     segment elevation myocardial infarction (STEMI).Slow flow / no-reflow phenomenon following~     PPCI in STEMI patients has been a serious and common complication that closely related to the~     incidence of major adverse cardiovascular events (MACE) and affected patients' prognosis. No~     reflow is a multi-factorial phenomenon. And its preventive and therapeutic effects are not~     satisfactory. This prospective randomized controlled study aimed to compare favorable effects~     of Nitroprusside versus Tirofiban on the prevention of slow flow / no-reflow phenomenon~     during PPCI.~   "
12223|NCT03406806|"~     The purpose of this study is to validate the walking velocity measured by the Gaitbox as~     compared to the measures obtained by clinicians administering the timed 4 meter walk test and~     the Sprint System device. The investigators have developed a compact device, the Gaitbox,~     which measures walking speed automatically. The device has an infrared light sensor that is~     capable to accurate distance measurements. To take a speed measurement, the device is placed~     at the end of the walking path and the subject simply walks towards the device. The device~     automatically records a starting and ending distance and calculates and displays walking~     speed in m/sec. This is a prospective, single site study. Up to 60 subjects will be enrolled~     at Duke. Subjects will be asked to complete the 4-meter walk test, three (3) times. Three~     speed measuring methods will be conducted simultaneously: NIH toolbox 4 meter clinic walk~     test and the Sprint System device (commercially available device typically used for timing~     track and field events), and the Gaitbox. The purpose is to validate the Gaitbox to the~     clinical NIH toolbox 4 meter test and against the Sprint System device. The following~     comparisons of speed will be made: Human timer 1 to human timer 2, Average human timer to~     Gaitbox, Gaitbox to Sprint System.~   "
12224|NCT03406793|"~     This is a randomized, double-blind, community-based efficacy trial of different doses, forms,~     and frequencies of zinc supplementation for the prevention of diarrhea and promotion of~     linear growth among children 9-11 months of age in Dhaka, Bangladesh.~   "
12225|NCT03406780|"~     HOPE-2 is a double-blind clinical trial evaluating the safety and efficacy of a cell therapy~     called CAP-1002 in study participants with Duchenne muscular dystrophy (DMD). Non-ambulatory~     and ambulatory boys and young men who meet eligibility criteria will be randomly assigned to~     receive either CAP-1002 or placebo every 3 months for a total of 4 doses during a 12-month~     period.~   "
12226|NCT03406767|"~     Osteoarthritis (OA) is the leading cause of disability worldwide and affects more than 4.4~     million people in Canada (13% of Canadians). OA symptoms include joint pain, stiffness, range~     of motion loss, and inflammation, resulting in a significant decrease in quality of life.~     Current evidence-based guidelines for OA management recommend weight loss, patient education,~     exercise therapy, bracing, viscosupplementation, and anti-inflammatory/pain medications prior~     to joint replacement surgery. Unfortunately, current practice trends are not consistent with~     these guidelines and focus largely on joint replacement. Recently, research from a group in~     Denmark has shown a reduction in the progression of knee OA symptoms, joint related~     painkiller use, individuals on sick leave, and higher physical activity levels 12 months~     after a combined patient education and standardized group exercise therapy program (GLA:D®).~     Based on the Danish success, the GLA:D® program has been made available in Canada. To date it~     is unclear if the GLA:DTM Canada program will result in outcomes similar to those seen in~     Denmark, or how the GLA:DTM program compares to existing individualized OA care programs~     (i.e. JointEffort). This research will answer the following three questions;~        1. Is the GLA:DTM standardized education and exercise program associated with improvements~          in functional mobility, quality of life, pain management, and inflammatory biomarkers in~          knee OA patients in Calgary, Alberta?~        2. Is the JointEffort individualized exercise and education program associated with~          improved functional mobility, quality of life, pain management, and inflammatory~          biomarkers in knee OA patients in Calgary, Alberta?~        3. Do the improvements in functional mobility, quality of life, pain management, and~          inflammatory biomarkers in knee OA patients differ between those enrolled in the GLA:DTM~          and the JointEffort education and exercise programs?~   "
12227|NCT03406754|"~     The present study examines the effectiveness of the rehabilitation program in the framework~     of the Ezra LeMarpeh project for Parkinson's patients. The Ezra LeMarpeh Association,~     founded by Rabbi A. E. Firer, provides assistance to the sick and needy. The site features a~     wide range of advanced, high quality rehabilitation devices, a unique hydrotherapy pool and~     associated accessories that enable the staff to provide the finest quality and most~     professional treatment. Before entering a rehabilitative program, each participant will~     arrive independently at the Ezra LeMarpeh Center for evaluation tests and will undergo~     comprehensive evaluation tests by the center's physiotherapist, including walking tests,~     balance tests, filling out questionnaires to assess Quality of life and disease severity. At~     the end of the program, the participants will be asked to repeat evaluation tests.~   "
12228|NCT03406741|"~     Hirschsprung's disease (HD) is a rare congenital disease (1:5000) characterized by neonatal~     functional low bowel obstruction that is caused by aganglionosis of the distal bowel. HD~     treatment consists in surgery of colonic reduction in the early childhood, requiring~     afterward a long-term follow-up. In the long term complications (incontinence, constipation,~     enterocolitis, soiling)but also iterative anesthesia in childhood and repeated~     hospitalizations can have negative effects on child's development.~      The main aim of the study is to estimate neuropsychological development at school age (6-10~     years). Of children operated of HD Secondary aims are evaluation of the neuro-driving~     development and global health, comparison of quality of life levels to those of French~     population standards as well as to study the complex relations between on one hand the~     quality of life of these children and on the other hand the socio-demographic data, the~     initial clinical elements and the surgical coverage, as well as their health and current~     cognitive profile.~      This multicenter study included pediatric surgery departments of Marseille. All children born~     between 1/1/2005 and 31/12/2010 and presenting HD represent the population. All the families~     will be contacted resting on the networks of set up follow-up. A written agreement will be~     collected with the parents. For all the participating children, a consultation will be~     organized: quality of life data (reported by children and by their parents in validated~     standardized questionnaires), clinical examination of the child, cognitive profile of the~     child. The duration of inclusion is scheduled for 12 months.~      This is the first French study using auto-reported data on children's quality of life at~     school age affected by a HD. The results of this study will allow developing hypotheses on~     predictive risk factors for neuropsychological development disorders. Besides a better~     knowledge of the relation existing between these children quality of life and their~     functional results due to the disease could help clinicians in their medical reflections.~   "
12229|NCT03406728|"~     This study aims to explore the use of full immersion virtual reality technology on improving~     balance in those with Parkinson's Disease. Patients will be immersed in a virtual environment~     and be tasked with completed games and activities, which mirror activities of daily living.~     It is hypothesized that this immersion in the virtual reality environment will improve their~     sensory pathways which are used to improve balance, decreasing falls.~   "
12230|NCT03406715|"~     The purpose of this study is to find out what effects (good and bad) immunotherapy treatment~     using the p53 vaccine (Ad.p53-DC) in combination with Nivolumab and Ipilimumab has on small~     cell lung cancer. Immunotherapy is a cancer therapy that uses the body's immune system to~     fight cancer cells.~      This study can be divided into three different phases: initial Induction Immunotherapy,~     Maintenance Immunotherapy and Retreatment.~   "
12231|NCT03406702|"~     This is a Phase 2a, multicenter, double-blind, placebo-controlled, parallel-group study~     consisting of a screening period of up to 4 weeks, a 4 week randomized double-blind,~     dose-titration treatment period, followed by a 1 week safety follow-up period after the last~     dose of study medication.~   "
12232|NCT03406689|"~     The analgestic efffect of Nepafenac 0.1% Eye Drops and Nepafenac 0.3% Eye Drops on pain~     related to intravitreal injections will be evalutated.~      Pain perception will be assessed by the Short Form of the McGill Pain Questionnaire.~   "
12233|NCT03406676|"~     To explore the effects of pre-treatment with methylene blue on reduced perioperative vascular~     resistance in patients with obstructive jaundice.~   "
12234|NCT03406663|"~     The aim of this study is to demonstrate efficacy and safety of self-titration algorithm with~     Gla-300 using the INSIGHT algorithm (once daily by 1 unit) and the EDITION algorithm (once~     weekly by 3 units) in Korean patients with T2D.~   "
12235|NCT03406650|"~     The main objective is to demonstrate that the addition of neoadjuvant and adjuvant~     immunotherapy with durvalumab, to standard neoadjuvant chemotherapy (with~     cisplatin/gemcitabine) and surgery in urothelial carcinoma could improve event-free survival.~   "
12236|NCT03406637|"~     Patients who received a total knee endoprosthesis BPK-S Integration between 2011 and 2013~     will be invited to participate in this PMCF study provided sufficient source data~     documentation is available regarding preoperative, intraoperative and early postoperative~     follow-up assessments.~      Only patients providing written informed consent prior to any study data collection can take~     part in the study.~      Preoperative, intraoperative and early postoperative data (3 months, 1 year and 2 years after~     implantation) will be collected retrospectively. Additional long-term follow-up of one visit~     (year 7 after implantation) will be documented prospectively.~      Only parameters assessed in clinical standard care for follow-up (implant control) visits~     will be collected for this PMCF study.~      Radiological assessment of the implanted prosthesis will only be conducted if medically~     indicated according to the investigator. No additional study related assessment will be~     performed.~      Only anonymized data will be used in this observational study to protect patient privacy. No~     personally identifiable information will be collected.~   "
12237|NCT03406624|"~     In the present study the investigators aim to examine the presence of bacteria in the disc~     and Modic Changes (bone) as well as characterize gene expression patterns and related markers~     to gain insight into molecular mechanisms that may be important for low back pain (LBP) and~     the development of Modic Changes (MCs). A case-control study with 1-year follow-up of two~     patient populations undergoing elective spinal surgery (spinal fusion or disc herniation~     surgery) will be conducted. 60 patients with MC (cases) and 40 without MC (controls) in each~     of the two patient populations undergoing either elective lumbar fusion surgery or disc~     herniation surgery will be included. The inclusion of control cultures from control patients~     is crucial since this may assist in determining whether a potential identification of low~     virulent bacteria in patients with MCs is due to true infection or contamination.~   "
12238|NCT03406611|"~     Cystathionine Beta-Synthase (CBS) Deficient Homocystinuria (CBSDH) is a rare~     autosomal-recessive metabolic condition characterized by an excess of homocysteine (Hcy) in~     the plasma, tissues and urine. It is due to reduced or absent activity of the Cystathionine~     Beta-Synthase (CBS) enzyme, and is also known as classical homocystinuria. The symptoms~     associated with CBSDH are variable in severity and time of onset across patients. Some~     affected individuals may have mild signs of the disorder; others may have multi-systemic~     involvement including potentially life-threatening complications. CBSDH can affect many~     different organ systems of the body; the four most commonly involved are the eyes, central~     nervous system, skeleton, and the vascular system.~      The current approaches to treatment of CBSDH patients include a highly restrictive diet and~     use of dietary supplements. Lifetime compliance with this diet is poor. OT-58 represents a~     novel therapeutic approach that incorporates the use of a modified version of the native,~     human CBS (hCBS) enzyme. The goal of treatment is to introduce the CBS enzyme into~     circulation, resulting in reduced Hcy levels, increased cystathionine levels and normalized~     cysteine (Cys) levels.~   "
12239|NCT03406598|"~     In shock patients, fluid resuscitation, infusion of vasopressors and transfusion are guided~     on hemodynamic macrovascular parameters. Analysis of sublingual microcirculation in shock~     patients is predictive of mortality and organ dysfunction. To optimize the quality of the~     resuscitation in shock patients, it could be useful to have an assessment of sublingual~     microcirculation in addition to the macrovascular parameters usually assessed by the nurses.~     But, this requires to have a monitor of sublingual microcirculation easy to use and to~     analyze at the bedside.~      The primary outcome of the present study is to test the ability of visual analysis of~     sublingual microcirculation by nurses to predict needs for fluid challenge, vasopressors or~     transfusion in patients in shock. After ICU admission and study inclusion, the nurses in~     charge of the patient will perform a set of measurements of macrocirculatory and~     microcirculatory parameters every 4 h during the first three days after ICU admission and~     before and after every hemodynamic therapeutic intervention, such as fluid challenge,~     transfusion of red blood cells or change in catecholamine rate.~      The secondary outcomes are to test 1/ to test the ability of visual analysis of sublingual~     microcirculation to predict organ dysfunction (SOFA score), and 2/ to evaluate the~     relationship between hemodynamic macrovascular and microvascular parameters. Intensive care~     patients in shock who need sedation, mechanical ventilation and invasive hemodynamic~     monitoring (Pulse Contour Cardiac Output (PiCCO 2 device)) will be included. In addition,~     patients will be included only when patients will obviously stay more than 24 hours in the~     ICU.~   "
12240|NCT03406585|"~     To investigate the safety and tolerance after allogeneic infusion of WJMSCs intravenously in~     adult patients diagnosed with type 1 diabetes.~   "
14057|NCT03382886|"~     This is an open label, phase I study to test for maximum tolerated dose (MTD) or recommended~     phase II dose (RP2D) of the combination of nivolumab and bevacizumab. The study will use a~     3+3 phase I study design using a fixed dose of nivolumab (240mg) and escalating doses of~     bevacizumab (1-10mg).~   "
12241|NCT03406572|"~     Chronic respiratory insufficiency and COPD are the third leading cause of death worldwide.~     Patients decompensate at various stages of their disease and exhibit acute-on-chronic~     respiratory failure (ACRF), a frequent cause of ICU hospitalization for hypercapnic acute~     respiratory failure (ARF). Non-invasive ventilation (NIV) is the first line ventilatory~     treatment for hypercapnic ARF. It is applied intermittently, separated by periods of~     spontaneous breathing (SB) with standard oxygen (O2).~      Standard O2 has drawbacks that limit the benefit of intermittent NIV in hypercapnic ARF:~     limited gas flow which is well below the patient's inspiratory flow rate, limited capacity~     and efficiency of oxygenation with non-controlled FiO2 (risk of excessive oxygen and induced~     hypercapnia), and cold and dry gas leading to discomfort and under-humidification of the~     airways and tracheobronchial secretions. Benefits in terms of work of breathing and CO2~     removal resulting from PEEP and pressure support applied during NIV periods could be rapidly~     lost during standard O2.~      Recently, use of high-flow heated and humidified nasal oxygen therapy (HFHO) has gained~     enthusiasm among intensivists to manage ARF. HFHO delivers high flows (up to 60L/min, that~     generate moderate PEEP) of heated and humidified oxygen at a controlled and adjustable FiO2~     (21 to 100%) that rapidly improve respiratory distress symptoms, oxygenation, respiratory~     comfort and outcome of patients with hypoxemic ARF.~      These unique features of HFHO could overcome some of the drawbacks of standard O2 during SB~     periods in hypercapnic ARF. Indeed, PEEP effect, washout of nasopharyngeal dead-space~     limiting CO2 re-breathing and inspired gas conditioning preserving adequate mucosal function~     and secretion removal, could potentially contribute to decrease airways resistance, intrinsic~     PEEP and work of breathing, while improving patient comfort. Investigators aim to determine~     if the use of HFHO, as compared to standard O2, increases the number of ventilator-free days~     (VFDs) and alive at day 28 in patients with hypercapnic ARF admitted in an ICU, an~     intermediate care, or a respiratory care unit, and requiring NIV.~   "
12242|NCT03406559|"~     the aim of this study is to document the changes brought about in the internal anatomic~     relationships of the TMJ complex , positional changes of glenoid fossa with respect to~     adjacent cranial structures after completion of fixed orthodontic treatment in adolescent~     males initially treated with removable functional appliances for skeletal class II, Angle's~     class II division 2 malocclusion~   "
12243|NCT03406546|"~     Therapeutic bronchoscopy is a common procedure to treat respiratory diseases. The procedure~     includes stent implantation, bronchus dilation, electronic incision, laser therapy, and so~     on. Most of these procedures are painful and require general anesthesia. Conventionally, the~     general anesthesia for therapeutic bronchoscopy was performed using laryngeal mask. But in~     the previous experiences, the investigators found that sedation with dexmedetomidine and~     remifentanil was as effect as laryngeal mask anesthesia. The present study was performed to~     compare the two approach for sedation or anesthesia in therapeutic bronchoscopy.~   "
12244|NCT03406533|"~     Diagnostic bronchoscopy is an invasive procedure performed to diagnose respiratory diseases.~     But pain has been complained by most of the patients receiving such procedures. Sedation or~     anesthesia was required by both of the patients and bronchoscopists. Unfortunately, no~     consensus has been made upon the sedation strategies. Multiple sedation approaches have been~     applied, such as midazolam and fentanyl, remifentanil and propofol, dexmedetomidine and~     propofol. The present study was designed to compare these protocols in sedation for~     diagnostic bronchoscopy.~   "
12245|NCT03406520|"~     The purpose of the study is to evaluate the efficacy and safety of chlorhexidine-impregnated~     disk in preventing catheter exit-site infection in peritoneal dialysis patients~   "
12246|NCT03406507|"~     The purpose of this study is to assess the pharmacokinetics (PK), pharmacodynamics (PD),~     safety, and efficacy of ALXN1210 in pediatric patients with paroxysmal nocturnal~     hemoglobinuria (PNH).~   "
12247|NCT03406494|"~     Despite of a remarkable decrease in overall mortality has been achieved following the~     International Guidelines for Management of Sepsis and Septic Shock since 2004,the short-and~     long-term outcomes remain poor in critically ill sepsis patients who had experienced~     prolonged ventilation in the Intensive Care Unit (ICU). The reason could be due to some~     subsequent complications developed in the ICU rather than original disease, e.g.,~     ICU-acquired weakness (ICUAW), delirium, diaphragmatic dysfunction (DD) and acute~     gastrointestinal (GI) injury, which are still not fully recognized or dealt with in a~     majority of ICU settings across China. This study is aimed to examine whether a~     multi-component physical therapy (PT) program against these lethal ICU-related complications~     could reduce ICU 28-day mortality, improve independent functional status and 1-year survival~     in this subset of patients.~   "
12248|NCT03406481|"~     The minimum period of fasting recommended by the 'American Society of Anesthesiologists' for~     the preoperative period is 6 hours for solid foods and 2 hours for clear liquids. Knowing the~     effect of preoperative fasting time on intravascular volume status may lead us to determine~     the amount of fluid to be administered intraoperatively. Cardiac preload static indicators~     are often insufficient to predict the need for fluid and are often measured by invasive~     methods. Knowing the adequacy of the preload is important in anesthesia practice; there is no~     hemodynamic benefit of fluid replacement in non-responsive patients. In this study, the~     investigators aimed to determine the effect of preoperative fasting period on cardiac index~     change after anesthesia induction in pediatric patients aged 5-12 years. The primary~     implication of this study is to determine the fasting period of fluid evacuation by assessing~     patients' intravascular volume status.~   "
12249|NCT03406468|"~     Radiotherapy in combination with different forms of immune therapy improved consistently~     local tumor control and very interestingly, lead to better systemic tumor control and the~     induction of specific anti-cancer immunity with a memory effect. In small series, it has been~     shown that a new long-lasting remission can be induced by irradiating one tumor site in~     patients who showed cancer progression after an initial response to immune therapy. In these~     series, the original immune therapy was continued and the treatment was very well tolerated.~     In this study the progression-free survival after radiotherapy to a single lesion will be~     investigated in patients with stage IV non-small cell lung cancer (NSCLC), who have at least~     achieved stable disease with immune therapy.~   "
12250|NCT03406455|"~     Subjectivity, cost-effectiveness, and inconsistent reporting limit monitoring after total~     knee arthroplasty (TKA). This prospective study leverages machine learning wearable~     technology to remotely monitor patients before and after TKA with fidelity and reliability,~     without sacrificing safe triage needing increased perioperative attention. Patients will~     download a mobile app that pairs with a smart knee sleeve to (1) monitor activity via daily~     step count, (2) solicit patient-reported outcomes, (3) calculate max flexion, and (4) provide~     physical therapy compliance data. The primary objective of this study is to determine~     validity and acceptability of the technology; secondary objectives include perioperative~     benchmarking with characterization of post-operative recovery trajectories.~   "
14058|NCT03382873|"~     The purpose of the study is to evaluate the impact of augmented care at the worksite through~     a lifestyle intervention for diabetes prevention among employees with prediabetes who are~     slower to respond to a standard diabetes prevention intervention.~   "
12251|NCT03406442|"~     To identify:~        1. The most frequent pathologies affecting pterygopalatine fossa, lateral recess of the~          sphenoid sinus, petrous apex, Meckel's cave, cavernous sinus, infratemporal fossa and~          lateral nasopharynx that can be treated by endonasal endoscopic transptergoid~          approaches, the most common presenting manifestations and indication of surgery.~        2. The different techniques and feasibility of different endonasal endoscopic~          transpterygoid approaches and the frequency of utilization of approach.~        3. Try to establish a protocol for post-operative care and management of complications.~        4. Obtain sufficient surgical experience in endonasal endoscopic transpterygoid surgery to~          establish endonasal endoscopic skull-base surgery in Assiut University Hospital.~   "
12252|NCT03406429|"~     The non-fluent/agrammatic (nfvPPA) and the logopenic (lvPPA) variants of Primary progressive~     aphasia are neurodegenerative diseases characterized by progressive word-finding difficulties~     and effortful speech. Efforts to slow or halt this progression have been largely~     unsuccessful. As such, there is a desperate need for novel treatment strategies in PPA.~      Repetitive transcranial magnetic stimulation (rTMS) is a safe, non-invasive way of~     stimulating cortical targets in a focal and reproducible manner. Therapeutic benefits from~     rTMS have been demonstrated when it is applied in many sequential sessions. For example,~     repeated sessions of rTMS to left dlPFC is an FDA approved treatment for major depressive~     disorder. With respect to language, high frequency (rTMS) increases the response rate for~     picture naming in healthy individuals. rTMS has also been shown to improve the number of~     correct naming responses in patients with Alzheimer's disease. Further, in a sham controlled~     study, Cotelli and colleagues demonstrated that in a group of 10 nfvPPA patients high~     frequency rTMS over the left and right dlPFC during object and action naming tasks improved~     the percent of correct responses for action, but not object naming. Finally, in a sham~     controlled single case study, Finocchiaro et al. applied high frequency rTMS to the left~     inferior mid-frontal gyrus for 3 sessions consisting of five consecutive days (treatment or~     sham). They found a significant and lasting improvement in the patient's performance on verb~     production when comparing active rTMS to sham rTMS or baseline. These studies have~     contributed valuable insights into the potential use of rTMS in treating the language~     symptoms of PPA patients.~   "
12253|NCT03406416|"~     This study is a proof of principal, to evaluate a safety and efficacy of a prototype~     suprachoroidal retinal implant.~   "
12254|NCT03406403|"~     To evaluate the efficacy of replacement of ETT with LMA and administration of Magnesium~     sulphate at the end of the surgery in attenuating systemic stress response during awakening~     of patients undergoing supratentorial tumours~   "
12255|NCT03406390|"~     Pterygium is the growth of conjunctival tissue onto the cornea, usually from the nasal~     quadrant of the cornea.Visual acuity may be reduced due to direct invasion of the visual axis~     or astigmatism induced by the pterygium. Contrast sensitivity measures two variables, size,~     and contrast which could comprehensively reflect the visual quality of the primary pterygium~     patients. In this study, we would investigate the the effects of primary pterygium on~     contrast sensitivity preoperatively and on the 1st, 3rd and 6th month postoperatively,~     moreover, the related parameters on the contrast sensitivity in the primary pterygium~     patients would be analyzed.~   "
12256|NCT03406377|"~     This study will evaluate the effect of dose escalation of once-weekly (QW) subcutaneous (SC)~     OPK-8003 injections vs placebo on HbA1c absolute change from baseline at 30 weeks in subjects~     with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise alone, or~     treated with a stable dose of metformin.~   "
12257|NCT03406364|"~     The proposed initial trial is a Phase I/IIa, open label study to evaluate the safety and~     explore efficacy of MG005 in combination with sorafenib in patients with solid tumor. The~     eligible patients will receive 200 mg of sorafenib with 3 pre-defined dose levels of GW5074,~     escalated from 750 mg to 1500 mg (daily dose), to determine the Maximum Tolerated Dose (MTD)~     and dose limiting toxicities (DLT) (if any) at Phase I stage. For the preliminary~     proof-of-concept stage (Phase IIa), a small number of patients will be recruited, and given a~     chosen dosing regimen of MG005 co-administered with sorafenib (a fixed-dose combination~     within the safe dosing range defined at Phase I) to assess its anti-tumor activity.~   "
12258|NCT03406351|"~     Societies become increasingly urban - more than half the world's population now lives in~     cities. Urbanization elevates anthropogenic (man-made) exposure to air pollutants. A clear~     association exists between exposure to air pollutants and exacerbations (worsening) of~     pre-existing asthma, incidence of nighttime asthma, difficulties with asthma control and~     increased disease risk. In 2012, the Public Health Management Corporation's Community Health~     Data Base estimated that 19.4% of adults in Philadelphia had asthma compared to a national~     prevalence of 7%.~      Asthma has a clear temporal signal. A majority of asthma patients, up to 75%, reports~     nighttime awakenings due to worsened cough, wheeze and dyspnea. This time-of-day-dependent~     exacerbation of symptoms, coined nocturnal asthma, is associated with poorer disease control,~     more frequent medication, and higher asthma-related morbidity and mortality. Consequently,~     several pathophysiological mechanisms proposed for nocturnal asthma relate to circadian clock~     biology.~      Lung function oscillates over the course of 24 hours, peaking around noon and reaching its~     nadir during early morning hours. Concentrations of air pollutants show oscillating patterns~     in urban settings.~      In this clinical research study, the investigators start to address how spatiotemporal~     fluctuations in air pollutants relate to asthma. Mechanistically, the investigators wish to~     address the hypothesis that microRNAs (miRs) act as interface between asthma phenotypes,~     circadian clocks and environmental exposure.~   "
12259|NCT03406338|"~     This randomized controlled trial will compare the outcome of surgery (fasciectomy) with that~     of local injection of Collagenase Clostridium Histolyticum in patients with recurrent finger~     joint contracture after previous treatment with either surgery or collagenase injection. Half~     of the participants will be treated with surgery while the other half will receive~     collagenase injection.~   "
12297|NCT03405844|"~     Shoulder injury is a common problem of overhead athletes, as swimmers. It's reported a~     reduction of side-to-side glenohumeral rotation from 11 to 18 degrees can increase 1.9 points~     the injury risk, because an alteration in biomechanics can turn lead to clinical findings of~     impingement and labral pathology. Posterior deltoid is a main muscle for propulsion in~     swimming stroke. To our knowledge, it isn't known how a posterior deltoid static passive~     stretch could reduce glenohumeral rotation restriction after swimming competition.~   "
12260|NCT03406325|"~     Activation of mast cells in the immune system is known to cause allergic reactions sometimes~     with severe systemic symptoms. The investigators have recently developed a blood-based mast~     cell activation diagnostic test in which levels of functional activation in-vitro in primary~     cultured mast cells generated from the peripheral blood of single individuals can be~     assessed. It is the hypothesis that the test can be used to predict the potential state of~     in-vivo mast cell activation in any individual based on the functional activation profiles~     exhibited by their cultured mast cells. The investigators now wish to translate their~     in-vitro findings in a pilot study to disease groups where mast cell activation is expected~     to be high. These include highly allergic individuals; those with chronic idiopathic~     urticaria; those with mastocytosis; and those with the mast cell activation syndrome.~     Furthermore, they will use the functional genomics approach to identify gene expression~     biomarkers that are correlated with such diseases. The results will be compared with data~     that have been collected from a cohort of healthy control blood donors.~   "
12261|NCT03406312|"~     Roux-en-Y gastric bypass (RYGB) leads to weight reduction but has also some unwanted side~     effects. A part of this population will develop postprandial reactive hypoglycemia (PPRH). At~     this moment no validated diagnostic tool exists for PPRH. The aim of this study is to prove~     an association between the Sigstad´s Score and the lowest postprandial glucose level in~     patients after RYGB surgery. This is investigated using a liquid mixed meal tolerance test~     (LMMTT). As a secondary hypothesis, associations between Edinburgh Hypoglycemia Scale (EHS)~     and postprandial glucose levels are investigated. Furthermore, changes of insulin and GLP-1~     levels during the test are analysed. Patient characteristics including co-morbidities are~     studied as possible influencing parameters. Moreover, a healthy control group is included to~     validate the results. Finally, a flowchart/diagnostic method will be proposed for diagnosing~     patients who had a RYBG surgery with symptoms suggestive of PPRH. Besides the LMMTT,~     participants at the Ghent University Hospital will undergo additional tests such as a solid~     mixed meal tolerance test (SMMTT) and continuous glucose monitoring (CGM). Associations~     between Sigstad Score, EHS and the lowest glucose measured during CGM and SMMTT will be~     investigated and compared to the results of the LMMTT.~   "
12262|NCT03406299|"~     To evaluate the following items in patients with locally advanced and metastatic biliary~     tract cancer receiving SLOG or GC treatment, Primary objective: 6-month progression-free~     survival rate~      Secondary objectives:~      Objective response rate Disease control rate (Objective response rate (ORR) + stable disease~     ≧ 12 weeks) Progression-free Survival Overall survival Safety profile Biomarker study~   "
12263|NCT03406286|"~     This is a Post-Marketing Surveillance study of Samsca® tablets in actual use in cases to slow~     the progression of cyst development and renal insufficiency in accordance with Korean~     regulations on Risk Management Plan(RMP) and New Drug Re-examination. This survey is a~     post-marketing, prospective, single-arm, all-cases survey conducted on approved indication,~     usage, dosage. The follow-up period shall basically start at the administration start and~     last until the end of the survey.~   "
12264|NCT03406273|"~     HITC001 is a single institution study to evaluate the efficacy of using a standardized~     protocol of surgery and radiation for patients with brain metastases in relapsed~     neuroblastoma.~   "
12265|NCT03406260|"~     The purposes of this study are to evaluate the effect of lasmiditan on blood pressure, as~     well as to look at the amount of study drug that gets into the blood stream and how long it~     takes the body to get rid of it in healthy elderly participants. The tolerability of the~     study drug will also be evaluated. Information about any side effects that may occur will~     also be collected. This study will take about 11 days, not including screening. Screening is~     required within 28 days prior to the start of the study.~   "
12266|NCT03406247|"~     Two randomized trials of reirradiation after salvage surgery have been conducted by the~     GETTEC and GORTEC collaborative groups, both members of the French HN Intergroup: The first~     trial compared reirradiation and a wait and see attitude and was published in 2008 [1]. The~     second trial compared two modalities of reirradiation. Our hypothesis is that adjuvant~     treatment with immunotherapy will lead to a DFS similar to that observed in previous trials~     of post-operative reirradiation with possibly lower toxicity.~   "
12267|NCT03406234|"~     An observational study was conducted in a health examination center to distinguish risk~     factors for health in a randomly recruited volunteers of Chinese population.~   "
12268|NCT03406221|"~     This study is designed to evaluate the impact of use of mobile technology by community-based~     health workers on health-promoting behaviors among women related to reproductive, maternal,~     newborn and child health and nutrition in Bihar, India.~      The intervention was funded by the Bill and Melinda Gates Foundation (BMGF) and in~     collaboration with CARE was implemented from 2012 to 2014. Health sub-centers in the~     catchment areas of four blocks (sub-districts) of the district of Saharsa were randomly~     assigned to treatment or control arms (35 sub-centers were assigned to each). Data were~     collected in the Intervention and Control areas from mothers of infants 0-12 months at~     baseline and at 2-year follow-up, to assess the intervention's effects on quality and~     quantity of FLW home visits, postnatal health behaviors, and among older infants/toddlers,~     complementary feeding and vaccination. Difference in difference analyses were used to assess~     outcome effects in this quasi experimental study.~      The ICT-CCS intervention was implemented in areas where the BMGF-funded Ananya program~     (official title: Bihar Family Health Initiative) was also being implemented. Thus, the impact~     is of the [ICT-CCS intervention + Ananya] versus [Ananya alone]. The Ananya program was~     developed and implemented via a partnership of BMGF, CARE, and the Government of Bihar. The~     ultimate purpose of Ananya was to reduce maternal, newborn, and child mortality; fertility;~     and child undernutrition in Bihar, India. Ananya involved multi-level interventions designed~     to build front line health worker (FLW) capacities and reach to communities and households,~     as well as to strengthen public health facilities and quality of care to improve maternal and~     neonatal care and health behaviors, and thus survival. It was implemented from 2012 to 2014.~     Eight focal districts in western and central Bihar received Ananya, while 30 districts did~     not.~   "
12269|NCT03406208|"~     The aims of this study are to compare the effect and durability of two stress and symptom~     management programs tailored for patients with neurofibromatosis on quality of life and~     psychosocial functioning.~   "
12298|NCT03405831|"~     This study evaluates whether treatment with ivabradine compared to placebo can improve~     exercise capacity in long-term heart transplant recipients with cardiac allograft~     vasculopathy and elevated heart rate at rest.~      Patients will receive treatment with either ivabradin or placebo for a period of 12 weeks.~   "
12527|NCT03402854|"~     The goal of this study is to test the efficacy of transcranial direct current stimulation~     combined with bimanual training on hand function in children with unilateral spastic cerebral~     palsy (USCP). Children who enroll in the protocol will be randomized to receive either sham~     (not stimulating) tDCS plus bimanual training, or active (stimulating) tDCS plus bimanual~     training.~   "
12270|NCT03406195|"~     The goal of this study is to evaluate the effect of white matter guided theta burst~     stimulation on episodic memory task performance in healthy older adults. The investigators~     aim to propagate the effect of theta burst stimulation from a superficial locus of~     stimulation (angular gyrus) to hippocampus and parahippocampal regions using white matter~     tract connection between these regions. Study activities and population group - for the study~     plans to recruit 20 healthy older adults who already have white matter scans acquired as part~     of another study performed by the Cabeza Lab at Duke University.~      Using tractography the exact site of stimulation on the cortical surface will be localized.~     An initial motor evoked potential (MEP) assessment will differentiate responders to theta~     burst stimulation from non responders. Responders will receive 1200 pulses of intermittent~     theta burst stimulation (iTBS) or sham stimulation to the angular gyrus while they perform~     the encoding portion of an episodic memory task. There after, they will perform retrieval~     piece of the task and data analysis will compare these performances.~   "
12271|NCT03406182|"~     Background Over the last 10 years there has been an increase in the female agriculture labour~     force, in Pakistan, resulting in a feminisation of agriculture; which could have either a~     positive or negative impact on maternal and young child nutrition. It could have a positive~     impact through increased female wage earnings that improve her bargaining/decision-making~     power within the household. Women are more likely than men to make pro-nutrition choices with~     regards to household expenditure. Conversely, women's involvement in agricultural work may~     have a negative impact on infant or maternal nutrition by reducing time available for child~     care, through increased expenditure of physical energy without compensatory increases in food~     consumption or exposure to harmful toxins present in pesticides and other chemicals used in~     farming. Understanding the dynamics of these pathways, in a specific context, is important to~     ensure agriculture programmes and policies do not disadvantage women or their children.~      Overall aim To provide insights into positive and negative pathways between women's work in~     agriculture and maternal and child nutritional status, in different agriculture workload~     contexts, to inform agriculture interventions and policies in Pakistan.~      Specific Objectives~        1. To determine whether the number of hours a mother participates in agriculture work is~          associated with maternal body mass index and infant nutrition.~        2. To identify factors that modify the influence of maternal participation in agriculture~          work on maternal and infant nutritional status.~      Study Design A cohort study was conducted from September 2015 in irrigated rural areas of~     Pakistan. Infant-mother dyads were recruited when the infant was between 2 and 12 weeks of~     age inclusive. Anthropometric measurements (maternal and infant height / recumbent length and~     weight), interviewer administered questionnaires and spot observations were collected at~     recruitment (Time 1) and again when the infants were between 9-15 months of age (Time 2). The~     interviewer administered questionnaires were collected from each infant's mother (or the~     household head if the father was not present). A one page questionnaire was also completed at~     recruitment to record the numbers of women who agreed to participate in the study, the number~     who were approached but were not recruited into the study and the reasons they were not~     eligible to participate or their reasons for refusal.~   "
12272|NCT03406169|"~     The study is a prospective, randomized, double-blind, placebo-controlled drug study to~     evaluate the pattern of erectile function recovery after robotic assisted laparoscopic~     prostatectomy (RALP). We hope to illustrate that early and continuous therapy with either~     Sildenafil citrate or pentoxyfylline after nerve sparing RALP will promote improved erectile~     function.~   "
12273|NCT03406156|"~     A study in previously untreated Chronic Lymphocytic Leukemia to evaluate alternate~     administration strategies for induction therapy (debulking) with obinutuzumab or~     obinutuzumab/bendamustine prior to combination therapy with obinutuzumab and venetoclax,~   "
12274|NCT03406143|"~     The purpose of this study is to evaluating whether autologous Concentrate Growth Factors(CGF)~     is safe and/or effective to accelerating skin regeneration and soft tissue expansion.~   "
12275|NCT03406130|"~     The aim of the present randomized controlled clinical trial will compare Insignia orthodontic~     treatment to piezocision-assisted Insignia orthodontics in adult patients. The primary~     objective will be to determine the efficacy of piezocision-accelerated orthodontic treatment~     by measuring the treatment duration in both groups. The secondary objectives will be to~     compare periodontal health, alveolar crest changes, bone and gingival healing, analgesic~     intake and patient-centered outcomes between the 2 groups.~   "
12276|NCT03406117|"~     The objective of this clinical study is to assess the irritation and sensitisation potential~     of HAT1 topical products after repeated patch applications to healthy human participants by~     following conventional Repeated Insult (HRIPT), Cumulative Irritation (CIT), and~     Phototoxicity (PT) methodologies under the supervision of dermatologists.~   "
12277|NCT03406104|"~     The goal of this clinical trial is to assess the long-term safety and efficacy of GS010, a~     gene therapy, and assess the quality of life in subjects with LHON due to the G11778A ND4~     mitochondrial mutation and who were treated in the Rescue or Reverse studies.~   "
12278|NCT03406091|"~     The study is an italian multicentric and will be conducted in 20 centers. The aim of this~     study is to evaluate poor mobilizer (PM) rate in newly diagnosed MM patients who are~     mobilized with cyclophosphamide and G-CSF and plerixafor on demand.~      Plerixafor is a specific reversible inhibitor of the chemokine receptor CXCR4 and prevents~     the binding of its ligand stromal cell derived factor SDF-1α also known as CXCL12, thereby~     releasing hematopoietic stem cells into the circulation.~   "
12279|NCT03406078|"~     Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Reducing Oral~     Corticosteroid Use in Adults with Oral Corticosteroid Dependent Asthma~   "
12280|NCT03406065|"~     The purpose of this study was to verify the effect of 10-day sodium bicarbonate (NaHCO3) and~     placebo (PLA) supplementation on physical and specific performance capacity, as well as~     concentrations of the selected biochemical blood markers in trained combat sports athletes,~     in a randomised, double-blind, placebo-controlled trial.~   "
12281|NCT03406052|"~     Randomized controlled trial (RCT) comparing youth diagnosed with major depressive disorder~     treated with online mindfulness-based cognitive behavioural therapy vs. standard psychiatric~     care (as wait-list controls). Eligible subjects will be recruited from the wait-lists of the~     Centre for Addiction and Mental Health. N = 168 subjects will consist of youth from First~     Nations background (18-30 yrs) and youth from all other ethnic backgrounds stratified to two~     intervention groups and two wait-list control groups consisting of 50% First Nations youth~     and 50% youth of all other ethnic backgrounds.~   "
12320|NCT03405545|"~     This human intervention study will test if supervised HIIT-based intervention improves~     skeletal muscle NOGD capacity in obese subjects. Moreover, we aim to investigate whether the~     consumption of an insulinogenic, CHO-rich drink during and after exercise prevents the~     adverse effects related to blood glucose fluctuations (energetic feelings, mood state) while~     maintaining the effect of HIIT on NOGD and promotes the adherence of the subjects to the~     training program in the long term.~   "
14696|NCT03374579|"~     finding surrogate to co to trace the effect of preload challenge would make the test more~     applicable without the need of advanced hemodynamic monitors,suggested that co2 gap can be~     used to detect FR after mini fluid challenge and fluid bolts .~   "
12282|NCT03406039|"~     Considering the high comorbidity between alcohol use disorders and emotional problems, there~     is currently a need for accessible, integrated treatments designed to target both disorders~     simultaneously. Evidence suggests that the combined use of Cognitive Behavioural Therapy~     (CBT) and Motivational Interviewing (MI) may be effective at reducing the combined symptoms~     of the two disorders. However, much of the empirical work has focused on testing the~     usefulness of CBT/MI for alcohol misuse and comorbid depression, and the majority of these~     studies involve in-person treatment. Therefore, additional empirical research is required to~     determine the efficacy of combined CBT and MI for alcohol use and both anxiety and depression~     using an online intervention. This may help inform future treatments in this domain, and~     potentially be able to inform the development of online, accessible interventions for this~     population.~      Participants (N = 214) with elevated levels of alcohol use and emotional problems will be~     recruited from Central and Eastern Canada. Participants will be randomly assigned to either~     the treatment group (i.e., combined CBT and MI), or the psycho-educational control group.~     Individuals in the treatment group will be given 8-weeks to work through 12 online modules.~     Throughout the modules, participants will identify goals related to alcohol use and mood,~     learn strategies to cope with alcohol cravings, triggers, and social pressures, and learn how~     to prevent relapse. Modules will also include content designed to target anxiety and~     depression, focusing on strategies designed to help reduce negative thinking and worry,~     increase behavioural activation, and increase self-care (e.g., relaxation techniques, sleep~     hygiene). Participants randomly assigned to the control (i.e., psycho-education) condition~     will receive links to websites that provide general psychoeducation about alcohol and mental~     illness. All participants will complete online assessment measures at baseline, at the end of~     treatment, and at follow-up approximately 4 months later) in order to assess the efficacy of~     the treatment. At the end of the study, individuals in the control group will be given full~     access to the treatment.~   "
12283|NCT03406026|"~     The aim of the study is to evaluate if the application of a protocol focused on the~     equilibrium systems versus the conventional treatments decreases the time to acquire~     equilibrium in standing, the risk of falls and favors the early initiation of treatments~     aimed at recovering the physiological gait.~   "
12284|NCT03406013|"~     This pilot clinical trial studies how well the True NTH Community of Wellness internet-based~     exercise and diet support works in improving diet and exercise habits in prostate cancer~     survivors. Internet-based exercise and diet support may help better control treatment-related~     side effects and symptoms, better overall quality of life, and lower risk factors associated~     with cancer progression.~   "
12285|NCT03406000|"~     Primary Objective:~      To evaluate the efficacy of switching treatment from twice-daily basal insulin to once-daily~     insulin glargine (U300) as part of basal bolus regime in terms of glycated hemoglobin~     improvement (reduction by at least 0.3%), in uncontrolled type 1 diabetes mellitus patients.~      Secondary Objectives:~        -  To evaluate other efficacy parameters in terms of glycemic control as well as safety~          including hypoglycemia events, weight changes, and adverse events.~        -  To evaluate the effect of insulin glargine (U300) on diabetes treatment satisfaction and~          fear of hypoglycemia as well as patient's satisfaction regarding the number of daily~          injections.~   "
12286|NCT03405987|"~     The association of T1-mapping (both native and ECV) and strain analysis of LV and RV by CMR~     will be assessed. Results from strain analysis will be investigated in terms of their~     prognostic value.~   "
12287|NCT03405974|"~     The purpose of this study is to determine if prolonged administration of low-dose aspirin~     will prevent the progression of early-stage osteonecrosis of the femoral head and may even~     reduce the extent of involvement of the femoral head by the necrotic process The design is~     intended to be parallel group where a total of 114 patients will be randomized in a 1:1 ratio~     to the treatment (ASA) and the control (Placebo) arms.~   "
12288|NCT03405961|"~     In dentistry, Peer Assessment Rating (PAR) is an objective way of quantifying how maligned a~     patient's teeth are by scoring orthodontic study models. It can also be used to assess~     treatment outcome by comparing pre- and post-treatment scores. Traditionally, PAR scoring is~     performed manually on plaster casts by a trained and calibrated individual. The plaster casts~     consume considerable amounts of storage space and the process of manual scoring can be time~     consuming and expensive. The recent decades have seen a rise in popularity of intra oral~     scanners in dentistry to produce digital study models. These obviate the need for physical~     storage space and a software can be used to calculate PAR scores more conveniently and at a~     faster speed. A review of the current literature showed that the CS 3600 intra oral scanner~     by Carestream Dental demonstrated acceptable accuracy for clinical use.~      In this study, patients will receive the usual impressions and their moulds will be PAR~     scored manually (usual care pathway). In addition, they will also receive intra oral scans~     with Carestream 3600 and the digital models will be scored by a computer. Manual and digital~     scores will be compared and analysed for any significant discrepancies.~   "
12289|NCT03405948|"~     Botulinum toxin is the main treatment for focal spasticity but the effects of botulinum toxin~     injections with respect to limitations of gait activities are still discussed. The aim of~     this study is to to investigate the effects of intramuscular Botulinum toxin type A~     injections on quantitative gait parameters (gait speed, step length and width, single support~     time) and posture, in hemiparetic post stroke patients with lower limb spasticity.~   "
12290|NCT03405935|"~     The primary objective of this study is to characterize the virologic efficacy of switching~     virologically suppressed participants on an elvitegravir/cobicistat/emtricitabine/tenofovir~     alafenamide (E/C/F/TAF) fixed-dose combination (FDC) regimen or a tenofovir disoproxil~     fumarate (TDF) containing regimen to bictegravir/emtricitabine/tenofovir alafenamide~     (B/F/TAF) FDC.~   "
12291|NCT03405922|"~     The aim of this study is to evaluate whether a local perianal block performed during a~     proctological intervention can reduce the postoperative pain.~   "
12292|NCT03405909|"~     Aim of this prospective national multicenter study is to improve standardization of~     contrast-enhanced ultrasound (CEUS) in the non-invasive diagnosis of hepatocellular carcinoma~     (HCC) in high-risk patients.~      The study is funded by the German Society for Ultrasound in Medicine (DEGUM).~   "
12293|NCT03405896|"~     The Validity and Reliability of a Wearable System for Assessing Turning Characteristics.~   "
12294|NCT03405883|"~     Characterization of the uterine microbiome in women with repeated implantation failure as~     well as in normal fertile women.~   "
12295|NCT03405870|"~     Briefly, this pilot clinical trial will evaluate preliminary safety and efficacy of the study~     drug (Smoflipid) at elevating cholesterol levels (primary outcome) in patients with sepsis~     and moderate organ dysfunction and will also evaluate measures of organ dysfunction,~     mortality, and biological activity (secondary outcomes).~   "
12296|NCT03405857|"~     The purpose of this study is to investigate the effect of cognitive rehabilitation program on~     the improvement of cognitive functions in patients with mild cognitive impairment(MCI).~   "
12299|NCT03405818|"~     This was an open-label study to evaluate the safety and pharmacokinetics of tavaborole 5%~     topical solution in treating distal subungual onychomycosis (a fungal infection) of the~     toenail in children and adolescents (ages 6 to 16 years).~      Following confirmation of eligibility, including laboratory evidence of a fungal organism in~     the toenail, tavaborole topical solution was applied once daily to all affected toenails for~     a 48-week treatment period.~      Clinical assessment of the extent of infection and safety assessments were performed~     periodically throughout the 48-week treatment period, and again at 52 weeks (4 weeks after~     stopping the treatment).~      A subgroup of enrolled subjects applied the topical solution to all 10 toenails and a small~     area of surrounding skin during the first 28 days. These subjects had blood samples analyzed~     to evaluate the pharmacokinetics (how the drug moves in the body) of tavaborole topical~     solution in children and adolescents.~   "
12300|NCT03405805|"~     The purpose of this study is to evaluate the establishment of immunological memory between~     the 3 different infant vaccination schedules with the 13-valent pneumococcal conjugate~     vaccine (PCV13) currently in use. We aim to determine the optimal schedule for the~     establishment of antigen-specific memory B-cell pool, which may serve as a correlate for~     longevity of immunological memory against vaccine serotypes. Moreover, we will study the~     transcriptome profiles expressed by peripheral lymphocytes during each immune response in an~     attempt to reveal immunological mechanisms beyond the antibody and circulating B cells level.~   "
12301|NCT03405792|"~     Glioblastoma multiforme (GBM) is the most common and deadliest primary malignant neoplasm of~     the central nervous system in adults. Despite an aggressive multimodality treatment approach~     including surgery, radiation therapy and chemotherapy, overall survival remains poor.~     Pembrolizumab has recently been approved in the United States for the treatment of patients~     with advanced and metastatic non-small cell lung cancer, recurrent or metastatic head and~     neck squamous cell carcinoma, locally advanced urothelial carcinoma, classical Hodgkin~     lymphoma, unresectable or metastatic melanoma~      This study is being performed to determine whether the triple combination of pembrolizumab~     when added to TTFields (Optune®) and adjuvant temozolomide increases progression-free~     survival (PFS) in patients with newly diagnosed GBM as compared to historical control data.~   "
12302|NCT03405779|"~     The primary objective of the study is to create a small dataset of regional pulmonary strain~     values in patients suffering from pulmonary diseases under mechanical ventilation in an~     intensive care setting.~      Hypothesis: The analysis of lung ultrasonographic sequences using speckle-tracking allows the~     determination of local pleural strain in 4 predetermined pulmonary areas in mechanically~     ventilated patients suffering from pulmonary diseases.~   "
12303|NCT03405766|"~     The study will explore barriers in the process of achieving informed consent from critically~     ill patients~   "
12304|NCT03405753|"~     Intervention cross-over study during which participants receive standardized amounts of~     aronia berry tablets or placebo for three months, then wash out for three months, then aronia~     tablets or placebo for three months. The potential health effects are investigated. Following~     parameters are measured before and after each period of tablet intake: 1) Blood pressure, 2)~     Lipid fractions, 3) Testosterone, 4) Phase II markers, 5) HbA1c, 6) HSCRP, 7)~     F2-isoprostanes, and 8) semen quality.~   "
12305|NCT03405740|"~     This is a Canadian multicenter randomized controlled trial to assess remote patient~     management. Patients will be randomized to remote patient management versus usual care, and~     will be stratified by RemoteView vs no RemoteView utilization, as well as by center.~   "
12306|NCT03405727|"~     Sarcopenia is defined as a decrease in muscular strength and muscle mass, accompanied by a~     decrease in physical performance. Seniors might develop sarcopenia because of a decreased~     physical activity and a decreased protein intake. Many patients also develop sarcopenia after~     a long stay in an intensive care unit.~      Protein intake is very important when treating sarcopenia. However, meeting the protein~     requirements at home proves difficult. Oral dietary supplements, given in addition to the~     other known recommendations, might provide a solution.~      This study will assess the efficacy of the oral dietary supplements for the treatment of~     sarcopenia.~   "
12307|NCT03405714|"~     The purpose of the study is to evaluate the pharmacokinetics (PK), safety, and tolerability~     of brivaracetam (BRV) administered intravenously (iv) in subjects >= 1 month to < 16 years of~     age with epilepsy.~   "
12308|NCT03405701|"~     In vitro maturation (IVM) is postulated to be an alternative to conventional in vitro~     fertilization (IVF) to avoid ovarian hyperstimulation syndrome. This has particular potential~     in women with Polycystic Ovarian Syndrome (PCOS), who are at increased risk for the ovarian~     hyperstimulation syndrome. However, no randomized controlled trials on the comparison of IVM~     and conventional IVF in women with PCOS have been reported with respect to pregnancy rate and~     hyper-stimulation. Investigators aim to compare the effectiveness and safety of IVM with~     controlled ovarian hyperstimulation/IVF in women with high antral follicle count.~   "
12309|NCT03405688|"~     Bearers of the sickle cell allele (S) are currently eligible for blood donations in Belgium.~     As blood donors are not tested for this allele, their heterozygous status is unknown.~     However, guidelines recommend to transfuse sickle cell patients with blood that is negative~     for the 'S' hemoglobin. To the investigator's knowledge, no study has been conducted to~     evaluate the impact of transfusion with blood originating from heterozygous donors on the~     transfusion performance and the improvement of clinical status of the sickle cell disease~     patients.~   "
12310|NCT03405675|"~     The Gerontology Research Programme (GRP) in the National University Singapore's Department of~     Psychological Medicine, was formed to coordinate and facilitate the conduct of~     multi-disciplinary research on in a wide range of research on ageing and health. The~     establishment of the Singapore Longitudinal Aging Cohort will provide a large community-based~     cohort of elderly subjects for observational studies with useful clinical applications.~     Research synergy is achieved in terms of pooling multi-disciplinary expertise, and combining~     genetic, biological, environmental, behavioural, social, clinical, and health services~     approaches to gerontological research.~   "
12383|NCT03404726|"~     To determine the safety, tolerability, pharmacokinetics, maximum tolerated dose, or~     pharmacological active dose of BAY2402234 in patients with acute myeloid leukemia (AML),~     myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML)~   "
12311|NCT03405662|"~     Photobiomodulation (PBM) describes the use of near-infrared light (which is not visible to~     the eye) to heal and protect tissue that has either been injured, is degenerating, or else is~     at risk of dying. Research suggests that the light delivered during PBM enhances the body's~     biochemical ability to store and use energy and increase blood flow, which triggers the~     body's natural healing processes. The goal of this study is to determine if PBM administered~     transcranially (through the scalp and skull) and intranasally (inside the nose) has an effect~     on cognitive function and behavioral symptoms in people with Alzheimer's disease (AD). The~     study will also examine whether PBM has an effect on biomarkers of AD in the blood and spinal~     fluid of patients with AD. A biomarker is a specific physical trait used to measure the~     progress of a disease or condition.~   "
12312|NCT03405649|"~     Among the well-known factors that contribute to the development of obesity, childbearing has~     been reported as an important influential factor. Physical activity is strongly recommended~     as one of the main tools to reduce any excessive weight gain during pregnancy and also to~     reduce weight retention in the postpartum period. During the postpartum period, exercise~     training coupled with a well-balanced nutritional plan, offers an effective intervention to~     help mothers lose weight safely. International guidelines for physical activity after~     pregnancy include strengthening routines. Worth noting, most of the above cited studies~     focused on the benefits of aerobic activities. Strength training interventions are virtually~     unexplored in postpartum women despite its potential benefits. Compared to the pregnancy~     period, postpartum barriers to physical activity seem to focus less on health-related~     barriers. In postpartum, time limitations for childcare become a more common barrier. For~     this reason, a postpartum exercise program that incorporates the babies in a specific~     exercise session has a better chance to succeed. The aim of this project is to determine the~     benefits of strength training in a group class setting in postpartum healthy women with their~     babies. Whereas mother's participation in regular physical activity may encourage regular~     physical activity habits in her offspring, a second aim of this project is to also quantify~     the infant's physical activity. The main measured outcomes are: maternal muscular strength;~     body composition; aerobic capacity; exercise self efficacy; depressive symptoms; physical~     activity level and food habits and baby's physical activity level.~   "
12313|NCT03405636|"~     This is a multi-center prospective, single-arm, non-randomized, open label study to assess~     safety and performance of the Xeltis Pulmonary Valved Conduit in subjects requiring Right~     Ventricular Outflow Tract correction or reconstruction due to congenital heart malformations.~   "
12314|NCT03405623|"~     When performing vascular cannulation such as radial artery cannulation, ultrasonography (US)~     helps proper positioning of the tip of needle in the vascular lumen, which facilitating~     cannulation of the catheter and successful pressure monitoring. Conventionally, short-axis~     out-of-plane (SAX) and long-axis in-plane (LAX) views are commonly used method to image the~     target vessel during cannulation under US guidance. Dynamic needle tip positioning (DNTP)~     method is newly introduced by one group of investigators who conducted a related study using~     vascular phantom model.~      In DNTP, SAX is used, and additionally, when the needle tip is imaged in the screen as an~     echogenic point, the practitioner (a) proximally moves the US probe a bit, and then (b) the~     needle is advanced until the needle tip reappears in the screen. In this manner, the~     practitioner repeats (a) and (b) until the needle is inserted 1 cm into the lumen of vessel,~     and then the catheter is inserted to finish the procedure.~      DNTP has not been compared to conventional imaging methods. The aim of this trial is to see~     the effect of DNTP on success rate of the radial artery cannulation at the first attempt,~     compared to the conventional LAX.~   "
12315|NCT03405610|"~     The aims of this study are to test a manualized skills-building program to address mood and~     coping aimed at preventing the development of chronic pain and disability following acute~     musculoskeletal injury in at-risk patients.~   "
12316|NCT03405597|"~     Chronic HBV infection is major problem in Asian countries. Years after chronic infection, in~     some cases serum HBsAg level declines to unmeasurable level. Some of patients develop~     anti-HBsAb but there is no standard treatment to accelerate HBsAg seroconversion.~      There is a study to determine efficacy and safety of HBV vaccine in who is Chronic HBV~     infection and lost their HBsAg without seroconversion to anti-HBsAb.~   "
12317|NCT03405584|"~     Dual therapy for Helicobacter Pylori including a proton pump inhibitor (PPI) and amoxicillin.~     Amoxicillin has low resistance rate as well as low percentage of side effects. No trial has~     examined the the efficacy of high dose of dual therapy plus bismuth for H. pylori~     treatment.This study is designed to evaluate the efficacy and safety of the addition of~     bismuth to high dose of dual therapy for H. pylori eradication.~   "
12318|NCT03405571|"~     Patients with newly diagnosed symptomatic multiple myeloma per IMWG criteria prior to therapy~     initiation are enrolled in the study. The aim of the study is to investigate clinical and~     disease related risk factors for venous thromboembolism (VTE) in these patients as well as~     possible biomarkers of hypercoagulability linked with the occurrence of venous~     thromboembolism at diagnosis and during the disease course. The purpose is to create a risk~     assessment model for VTE in newly diagnosed multiple myeloma patients and make the model more~     accurate by combining relevant clinical and disease characteristics with biomarkers of~     cellular and plasma hypercoagulability. A standardized clinical research form is completed~     for all patients at baseline, 3, 6 and 12 month follow up to include relevant clinical,~     patient-related, disease-related and treatment related data. Blood sampling also takes place~     at baseline and 3,6,12 months to assess multiple biomarkers of plasma and cellular~     hypercoagulability. In addition lowe limb ultrasound is performed at baseline, 6 and 12~     months. The primary endpoint is VTE occurrence. Following the elaboration of the~     ROADMAP-CAT-MM risk assessment model we will prospectively validate it. We expect that~     patients who are classified, as high risk according to the ROADMAP-CAT-MM will experience~     symptomatic VTE more frequently and will have higher morbidity and mortality rates during the~     follow-up. The prospective validation of the ROADMAP-CAT-MM will provide guidance for the use~     and choice of thromboprophylaxis in these patients and will identify high risk patients~     eligible for thromboprophylaxis with low molecular weight heparin (tinzaparin).~      In addition to symptomatic patients with multiple myeloma the study aims to investigate VTE~     risk in all plasma cell dyscrasias and will recruit patients with monoclonal gammopathy of~     undetermined significance, asymptomatic multiple myeloma, primary amyloidosis and~     Waldenström's macroglobulinemia.~   "
12319|NCT03405558|"~     A high physical fitness is crucial for a good quality of life in persons suffering from a~     spinal cord injury. The aim of the present observational study is to investigate the~     influence of an individually tailored 8-week endurance training program on endurance~     performance of patients with a paraplegia during their first rehabilitation.~   "
13169|NCT03394469|"~     This project aims first to determine the prevalence of sarcopenia in a population of obese~     people of extended age group (18-70 years). In a second step, the factors determining and /~     or predisposing to sarcopenic obesity will be identified as well as plasmatic and urinary~     biomarkers specific to this phenotype.~   "
12321|NCT03405532|"~     Filtration of urine in the kidney requires sufficient oxygen supply. The filtration of urine~     is greater in patents with diabetes. Our theory is that the diabetic kidney has a higher~     oxygen demand than the non diabetic kidney thereby making the diabetic kidney more sensitive~     to decreased oxygen delivery following reduced blood flow. With a catheter inserted into the~     kidney vein we will monitor the blood flow and oxygen saturation before and during CPB, in~     patient with diabetes.~   "
12322|NCT03405519|"~     Radiotherapy to the breast and lymph nodes is routinely planned using CT scans. The~     introduction of magnetic resonance imaging (MRI) has the potential to better visualise the~     lymph nodes and so define a smaller treatment area or 'target'. This means that the dose~     delivered to the target could be increased without increasing the dose to normal tissues. The~     MIRABELLE study is designed to test if this is possible by recruiting patients diagnosed with~     breast cancer including lymph node disease. The investigators will ask participants to have a~     CT scan and an MRI scan before they have radiotherapy. The investigators will then plan~     radiotherapy using both these scans and compare the possible dose delivered to the lymph~     nodes using the MRI and CT defined lymph nodes. This will not affect the patient's future~     treatment.~   "
12323|NCT03405506|"~     Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of~     coronary stenosis. Virtual stent implantation technique combined with QFR was recently~     developed to predict the functional significance of coronary stenosis as if the stenosis was~     revascularized.~      The purpose of this study is to evaluate the diagnostic accuracy of QFR in in tandem lesions~     with fractional flow reserve (FFR) as the reference standard. The secondary purpose is to~     evaluate the diagnostic accuracy of QFR-based virtual stent technique in predicting the FFR~     values after revascularizing the culprit lesion.~   "
12324|NCT03405493|"~     The aim of this study is to determine if altering the pattern of one's sleep and having light~     therapy can speed up the treatment of depression. In the UK, the large majority of patients~     with depression in the NHS are treated in the community, and one of the major objectives of~     the study one is to determine if this therapy is a practical treatment in the community. We~     will be comparing two treatments:~        1. Sleep Therapy and a Light Box: Participants will be given information and advice on how~          to get a good night's sleep. Participants will be given a light box to use in the~          morning for 1 week. Treatment with a light box will last 30 minutes when a person gets~          up. Participants may continue to have any treatment as usual (for example medication or~          talking therapies).~        2. Wake therapy and a Light Box: Participants will be helped to change the pattern of sleep~          by depriving participants of sleep for one night. Participants will go bed at 5pm on the~          following day for 8 hours and get up at 1am. Participants' sleep will then be advanced~          by 2 hours each night for the next three nights. Participants will be also given a light~          box to use in the morning for 1 week. Treatment with a light box will last 30 minutes~          when participants get up. Participants may continue to have any treatment as usual (for~          example medication or talking therapies).~   "
12325|NCT03405480|"~     This project aims to evaluate a rehabilitation program as treatment and uncover potential~     pathophysiological mechanisms of a newly identified chronic condition named Post Pulmonary~     Embolism Syndrome (PPS).~   "
12326|NCT03405467|"~     This observational study intends to analyze the characteristic of specific accidents happened~     in Austrian's mountainous regions. The mechanisms of accidents which are evaluated are~     lightning accidents, cardiopulmonary resuscitation with or without automated external~     defibrillator, frostbite injuries, accidents with flying vehicle (e.g. paraglider,~     hang-glider…).~   "
12327|NCT03405454|"~     The purpose of this study is to find out if treatment with a study drug, durvalumab has~     beneficial effects in people who have recurrent ovarian clear cell cancer and to determine~     what effects (both good and bad) it has on them and their cancer.~   "
12328|NCT03405441|"~     The purpose of this study is to assess safety and tolerability of day-time and night-time~     dosing of JNJ‑55375515 in healthy male participants.~   "
12329|NCT03405428|"~     In this study, the investigators will investigate how patients' radial artery diameters~     change according to sex, age, height, weight and body mass index by measuring radial artery~     diameter using ultrasonography. The correlation of Allen test with doppler ultrasonography~     will also be evaluated.~   "
12330|NCT03405415|"~     Participants will perform blood glucose monitoring (BGM) over the course of 14 days and, in~     parallel, wear continuous glucose monitoring (CGM) systems. Because current CGM systems~     typically achieve a lower level of analytical accuracy than BGM systems, participants will~     perform at least 5 blood glucose (BG) measurements per day. In addition, CGM systems are used~     to obtain minimally-invasive high-frequency glucose measurements to fill the gaps between BG~     measurements.~   "
12331|NCT03405402|"~     Sickle cell patients have a high prevalence of alloimmunization. This high rate of~     alloimmunization can be partially explained by the existence of an antigenic difference~     between the predominantly Caucasian donor population and the sickle cell patients of African~     origin. Genetic and environmental risk factors have also been described.~      The main risk factors that have been shown in retrospective or cross-sectional studies are~     some HLA alleles, the age of the patient, the number of leukocyte-depleted erythrocyte~     concentrates (CED) transfused, the number of transfusion episodes, the age of the CEDs, the~     existence of an inflammatory event at the time of transfusion and the presence of~     anti-erythrocyte autoantibodies.There is also evidence of an impaired TH response but the~     underlying immunological mechanism is not fully understood.~      The aim of this study is to study the prevalence and the risk factors for anti-erythrocyte~     alloimmunization and to try to understand the immunological mechanisms.~   "
12332|NCT03405389|"~     Following standard of care (routine) procedures, a total number of 50 patients suffering from~     a non-condylar and/or condylar fractures of the mandible requiring Mandibulo-maxillary~     fixation (MMF) for a minimum of two weeks during or subsequent to open reduction internal~     fixation (ORIF) will be prospectively enrolled in this focused registry.~      Classification of the injury and the time needed for application of the MatrixWAVE MMF system~     will be collected. Follow-up visits will be performed between 2 to 6 weeks and 3 months~     according to standard of care to evaluate the mandible function impairment, pain and local~     complications (anticipated procedure-related adverse events) related to the MatrixWAVE MMF~     system.~   "
12333|NCT03405376|"~     Retinal vein occlusion (RVO) includes central RVO (CRVO) and branch RVO (BRVO). A highly~     prevalent retinal vascular disease, RVO is second only to diabetic retinopathy. Most of this~     high prevalence is driven by BRVO; the yearly incidence of BRVO in the United States is~     150,000 and that of CRVO is 30,000. In CRVO, hemorrhages and edema develop throughout the~     retina, whereas in BRVO the pathology is more sectoral, involving the portions of the retina~     drained by the obstructed branch vein. This suggests that increased intraluminal pressure~     behind the obstruction may lead to transudation of blood cells and plasma into the retina.~     However, recent studies have demonstrated that although increased venous pressure may be the~     precipitating event for hemorrhages and edema, increased production of vascular endothelial~     growth factor (VEGF) occurs early in RVO and is a major contributor to their evolution and~     persistence. In addition, the high levels of VEGF contribute to progression of retinal~     nonperfusion and hence retinal ischemia, which may in turn increase production of VEGF, and~     may explain why some eyes enter a vicious cycle of worsening disease often referred to as~     conversion to an ischemic RVO.~      Treat-and-extend intravitreal anti-VEGF with age related macular degeneration and diabetic~     macular edema has been reported to offer the opportunity to indivisual management while~     minimizing treatment burden and similar visual and anatomical outcomes to those with fixed~     montly dosing.~      Also, small retrospective treat-and-extend intravitreal bevacizumab injection for treatment~     of BRVO associated macular edema demonstrated similar visual outcomes and number of~     intravitreal injections as did pro-re-nata treatment with ranibizumab conducted in phase 3~     trials but with fewer visits and lower annual medical costs.~      The effects of afilbercept have been reported to persist for over 8 weeks in DME and AMD~     studies. In addition, VIBRANT study also demonstrate that bi-monthly injection of aflibercept~     showed significant visual improvement in BRVO patients.~      In the treat-and-extend studies of RVO, ranibizumab has been extended for up to 4 months at~     intervals of 2 weeks. But, to our knowledge, there was no prospective study of~     treat-and-extend regiments with intravitreal aflibercept in treatment naïve patients in BRVO.~      The purpose of this study is to evaluate the efficacy and safety of the treat-and-extend~     regimen extending to 4 months by intervals of 4 weeks using intravitreal aflivercept~     injection for treatment of macular edema secondary to BRVO.~   "
12334|NCT03405363|"~     Examine the risk of cardiovascular events (cardiac arrhythmia or myocardial ischemia) or~     all-cause mortality in COPD patients who are new users of Olodateror or other LABAs available~     for the treatment of COPD.~   "
12335|NCT03405350|"~     Observation conducted during the 21 days of treatment in the health resort of Przerzeczyn~     Zdroj. In a treatment of applied therapy: redon-sulfide baths, partial mud baths,~     kinesitherapy, terrain therapy, dry massage, laser therapy, low-frequency magnetic field,~     ultrasonotherapy, cryotherapy, electrotherapy, light therapy. Study group with joint or back~     pain due to osteoarthritis or degenerative disc disease. The control group was selected by~     the spa workers, healthy individuals, nonsmokers, who did not drink alcohol. It was~     recommended to retain the previous lifestyle and use of resort's facilities was prohibited.~     In both of these groups, appropriate pre- and post-treatment studies were performed.~   "
12336|NCT03405337|"~     This US study will assess hemophilia A patient characteristics, health history and reasons~     for switching or not switching from both patient/caregiver and physician perspectives. For~     this purpose, this research study will include hemophilia A: 1) patients who have switched~     from conventional therapy to new FVIII products with an improved PK profile. 2) patients who~     remain on conventional therapy (who have never switched) but have considered switching,~     including those patients who switched from conventional therapy to new FVIII products with~     improved pharmacokinetics and then subsequently switched back to conventional replacement~     therapy. In doing so, real world evidence will be obtained from both patient and physician~     perspectives offering key insights for effective therapeutic management of patients with~     hemophilia A and to more fully understand what drives patient switching from a patient~     perspective and a physician perspective.~   "
12337|NCT03405324|"~     this work is looking for the effect of tDCS of the motor cortex on the chemotherapy induced~     nausea and vomiting in cancer breast patients~   "
12338|NCT03405311|"~     This study will be a randomized control study, with the objective to evaluate epidural~     analgesia success rates between the two methods (Blind Approach versus Accuro Device).~   "
12339|NCT03405298|"~     The goal of this project is to reduce chronic benzodiazepine use through two approaches:~     direct patient education or direct patient education paired with additional support and~     encouragement from a behavioral health care manager.~   "
12340|NCT03405285|"~     The objective of this study is to evaluate the safety and essential performance of the~     Connected Catheter System in males with neurogenic lower urinary tract dysfunction (NLUTD),~     both in an acute clinical setting, and during and extended period (up to 29 days) of home~     use.~   "
12341|NCT03405272|"~     The purpose of this study is to evaluate the efficacy and safety of recombinant anti-EGFR~     Monoclonal antibody（SCT200）in patients with wild-type RAS and BRAF mCRC treated with~     fluorouracil, oxaliplatin and irinotecan after failure of standard therapy~   "
12342|NCT03405259|"~     The objective of this study is to compare professional treatments for dentinal~     hypersensitivity immediately following a single, professionally-applied treatment and again~     approximately 2 months following treatment.~   "
12343|NCT03405246|"~     Adverse influences starting in utero may predestine an individual's long- term risk for~     developing cardiometabolic diseases. The Keeping Ideal CVH (cardiovascular health) Family~     Intervention Trial (KIDFIT) will test whether preschool-age children, born to~     overweight/obese (OW/OB (mothers who did or did not experience a diet and lifestyle~     intervention to reduce GWG: 1) demonstrate more favorable adiposity (body fat %), body mass~     index percentiles (BMI%), diet quality (DASH diet score), physical activity, and other CVH~     metrics at baseline according to antenatal intervention status; and 2) respond to an early~     childhood intervention targeting diet and lifestyle behaviors with improvement in these same~     adiposity and CVH metrics.~      We hypothesize children randomized to the KIDFIT diet and lifestyle intervention group at age~     3-5 years, regardless of initial maternal antenatal group assignment, will demonstrate more~     favorable adiposity changes assessed by anthropometry (body fat %/sum of skinfolds) and a~     lower cumulative incidence of obesity after the 12-month intervention, as compared with the~     control group. Additionally, after 12 months of the KIDFIT Intervention, children will have~     more favorable blood pressure and blood lipids, better diet quality (as measured by the~     DASH-style diet score), increased physical activity levels, and more optimal sleep duration,~     without adverse effects on height, compared to the control group~   "
12344|NCT03405233|"~     this randomized controlled trial will compare the double vein cuffed synthetic arteriovenous~     graft to the single vein cuffed synthetic and the non cuffed synthetic as regard to long-term~     patency of each modality~   "
12345|NCT03405220|"~     The aim of these studies is to adapt the self-affirmation kindness questionnaire for use in a~     mobile application. Two studies will be conducted to test hypotheses that simplifying and~     shortening the original questionnaire in systematic ways will result in comparable~     effectiveness (compared to the original version) in promoting reduced defensive avoidance,~     less reactance, greater yielding, and higher intentions to quit smoking among a sample of~     smokers.~   "
12346|NCT03405207|"~     The leading cause of death in the world is due to cardiovascular events, which originate from~     coronary artery stenosis therefore it affects myocardial blood flow and finally may cause~     infarction. Atherosclerosis is the most debatable hypothesis in coronary stenosis. Scientists~     think body inflammation is one of the main etiologies. There are many factors affect this~     inflammatory process, which Vitamin D is one of them. Vitamin D deficiency has been linked to~     various inflammatory diseases. However, the mechanism by which vitamin D reduces inflammation~     remains poorly understood. Vitamin D deficiency is pandemic around the world with 30-50%~     prevalence in adult population and several evidences advocated its association with~     immune-based disease. Additionally, there are some study suggesting patients who suffered~     from myocardial infarction have lower serum vitamin D level. It has been revealed Vitamin D~     deficiency has numerous major drawbacks on cardiovascular system. Its deficiency benefits~     atherosclerosis progression and may cause endothelial inflammation and dysfunction in~     coronary artery. There is not any evidences study vitamin D deficiency treatment on non~     ST-Segment Elevation Myocardial Infarction nor there is any study demonstrating its effect on~     cardiovascular health through Holick's protocol. Furthermore endothelial function, cardiac~     work retrieval and inflammation after 8 weeks has not been studied with this protocol yet.~      According to current data, the investigators assume by treating this vital and worldwide~     deficit in our body, doctors can help decrease inflammation, decelerate the atherosclerosis~     progression and enhance ventricular function after infarction.~      Besides all of the recognized risk factors, vitamin D deficiency should be considered a very~     important and mischievous cardiovascular alarm for the body, which should be treated and~     maintained through the whole life due to lack of sufficient sunlight exposure and nutrition~     intake.~      In preventive medicine domain, the investigators anticipate by maintaining a high level of~     this vitamin in the body, cardiovascular events decrease and its burden on society will~     decline to much extend leading to a higher quality of life and health worldwide.~   "
12347|NCT03405194|"~     Randomized, open-label study comparing Elvitegravir-Cobicistat-Tenofovir~     Alafenamide-Emtricitabine (Genvoya) vs. Efavirenz-Tenofovir Disoproxil Fumarate-Lamivudine~     (EFV-TDF-3TC) in patients starting ART on the day of HIV diagnosis.~   "
12348|NCT03405181|"~     The effects of additional weight on early motor skills of infants have been increasingly~     studied. During the reaching behavior, the additional weight has been shown benefits in~     certain kinematic variables in full term and preterm infants. There is a growing interest in~     the study of populations at risk for motor development, especially considering interventions~     based on functional activities with the purpose of improving the neuromotor control,~     functional capacity and muscle strength. The aim of the present study is to investigate the~     effect of a functional training with additional weight in the reaching behavior of preterm~     infants with low birth weight and to compare the effects with a full term population. A~     controlled and randomized trial will be carried out with full term infants of adequate birth~     weight and preterm infants with low birth weight at 6 months of chronological or corrected~     age. The participants will be recruited by convenience from the charts of a Public Hospital.~     Participants will be randomly allocated into four groups: 1) adequate weight placebo group~     (AWPG); 2) adequate weight intervention group (AWIG); 2) low weight placebo group (LWPG) and~     4) low weight intervention group (LWIG). . The assessor will be blinded (no knowledge of~     groups allocation). All infants will undergo a training program of eight sessions (2x/week; 4~     weeks). The AWIG and LWIG will receive the training with an additional weight (characterized~     by a bracelet with a weight of 20% of the mass of the upper limbs)and the AWPG and LWPG will~     receive the same training, however, without the additional weight (only the bracelets).. All~     infants will be assessed in three different moments: 1) Pre-intervention: baseline, before~     the start of the intervention program; 2) Post-intervention: evaluation performed after the~     end of the program; and 3) Follow-up: evaluation performed seven days after the~     post-intervention assessment. The following kinematic dependent variables will be calculated:~     straightness index, mean velocity and motion units and electromyographic variables: pattern~     of activation and recruitment of muscle fibers - Biceps brachialis, Triceps brachialis,~     Deltoid and Pectoralis Major muscles; co-activation between biceps and triceps. The Qualisys~     Track Manager (QTM) and a wireless surface electromyography with 8-channels will be used. If~     normality assumptions are met, a mixed 2X2 ANOVA with repeated measures will be applied, in~     order to verify differences between the intervention programs, considering the dependent~     variables. Otherwise, non-parametric procedures of the same nature will be adopted. The~     significance will be set at 5% (P<0.05).~   "
12349|NCT03405168|"~     This is a phase II,single center,prospective, single arm clinical trials. The objective is to~     evaluate the efficacy and safety of Antibiotic Plus TPC (Treatment of Physician's Choice) in~     Advanced Breast Cancer.Primary endpoint is PFS(Progress Free Survival).~   "
12350|NCT03405155|"~     This phase II trial studies how well nivolumab works in treating patients with stage IIB-IIC~     melanoma that can be removed by surgery. Monoclonal antibodies, such as nivolumab, may~     interfere with the ability of tumor cells to grow and spread.~   "
12351|NCT03405142|"~     This phase II trial studies how well panitumumab-IRDye800 works in identifying head and neck~     cancer that has spread to the lymph nodes in patients with head and neck cancer.~     Panitumumab-IRDye800 may help surgeons to identify metastatic lymph nodes during surgical~     removal of the primary tumor and/or lymph nodes of the neck with equal or better accuracy~     than the current methods.~   "
12352|NCT03405129|"~     Smoking is the leading preventable cause of death and disease in the United States. Although~     most smokers report that they would like to quit smoking at some point in the future, only~     20% are ready to quit within the next 30 days. Importantly, studies have indicated that~     interventions can increase motivation and/or readiness for cessation among smokers who are~     not yet ready to quit and these types of intervention can increase smoking cessation~     attempts. Smartphone apps that offer daily information about the benefits of quitting and~     motivational/supportive messages that aim to increase cessation self-efficacy may increase~     the likelihood of initiating a smoking cessation attempt. Previous research has indicated~     that smoking cessation smartphone applications are feasible and well-liked by smokers who are~     already committed to quitting smoking. However, there are no empirically supported smartphone~     apps that provide dynamic smoking cessation content that is automatically matched to a~     smoker's current readiness to quit. This type of dynamically tailored intervention could~     overcome many of the barriers that have hampered the widespread use of traditional~     empirically supported smoking cessation treatments. The current pilot study (N=150) is a~     3-armed randomized controlled smoking cessation induction trial that will determine the~     initial utility of a novel smartphone based intervention compared with an attention control~     group among smokers who are not yet ready to quit. The two intervention groups (Group 1:~     Phoenix App Only; Group 2: Phoenix App + Nicotine Replacement Therapy [NRT]) will receive~     targeted smoking cessation messaging that is matched to a participant's readiness to quit,~     while the attention control group (i.e., Factoid) will receive messages that are not related~     to smoking cessation.~   "
12353|NCT03405116|"~     A register and prediction model will be developed to predict the outcome of preterm labour~     and birth.~   "
12354|NCT03405103|"~     The vast majority of people want to be healthy and often make a change to be healthier.~     Change that is begun is seldom maintained. Osteoporosis is an example of one condition where~     people are encouraged to regularly engage in preventative health behaviors. This is a study~     testing a new approach to helping women engage in osteoporosis health behaviors. This new~     approach includes beliefs, self-regulating skills and abilities, and social facilitation~     delivered via a cell phone app. If effective, this approach could be tested with other health~     behaviors.~   "
12528|NCT03402841|"~     The purpose of the study is to assess the efficacy and safety of single-agent olaparib as a~     maintenance treatment in patients with relapsed High Grade Serous Ovarian Cancer (including~     patients with primary peritoneal and/or fallopian tube cancer) or high grade endometrioid~     cancer who do not have known deleterious or suspected deleterious germline BRCA mutations~     (non-gBRCAm) and who had responded following platinum based chemotherapy.~   "
12355|NCT03405090|"~     Activity-related breathlessness (dyspnea) is the dominant symptom and persists despite~     optimal medical care in as many as 50% of patients with advanced chronic obstructive~     pulmonary disease (COPD). The objective of this project is to determine the underlying~     mechanisms of the activity-related breathlessness in patients with advanced COPD. To study~     the different pathways involved in causing breathlessness, we will compare the effects of two~     treatments, opiates with oxygen versus bronchodilators, which relieve breathlessness in~     different ways.~   "
12356|NCT03405077|"~     Interpersonal psychotherapy (IPT) is an evidence-based therapy for the treatment of eating~     disorders (including binge eating disorder, bulimia nervosa, and disordered eating not~     meeting full diagnostic criteria). On a basic level, IPT is a time-limited treatment that~     helps the client understand the relationship between symptoms and social interactions.~     Traditional training methods require substantial cost, time, and resources, making~     evidence-based treatments difficult to disseminate. As such, college clinicians are not~     typically trained in IPT delivery, which prevents their clients from reaping the potential~     benefits of treatment. This study will attempt to show how technology can overcome such~     barriers to training dissemination.~      The purpose of this study is to see if online training in IPT is as effective as in-person~     training. To find out, the following procedures will occur: First, college mental health~     clinicians will complete baseline online questionnaires and deliver their usual treatment to~     1 or 2 clients with symptoms of eating disorders. Then, they will complete the guided online~     training program and post-training assessments. Next, they will treat 1 or 2 different~     clients with eating disorders and complete post-training assessments. As part of the baseline~     and post-training assessments, clinicians will complete a telephone-based simulation~     assessment with staff raters, in which the investigators will recreate a client session and~     rate how well the clinicians adhere to IPT in treating the simulated client. The guided~     on-line training program will ultimately be compared to the gold standard training (the~     group receiving in-person training in an associated, IRB-approved study, # 201111113).~   "
12357|NCT03405064|"~     This is a phase III, multi-center, randomized, active-comparator, study in subjects with~     ABSSSI. The study has two subgroups for assessment of efficacy and safety - oral subgroup 1~     and IV subgroup 2. Each subgroup will comprise of two treatment arms.~   "
12358|NCT03405051|"~     Hypokalemia is very common in heart failure patients. Deleterious effects have been report on~     the cardiovascular system. Most of the clinical data concerning this ionic trouble are based~     on post-hoc study and some findings seemed disjointed.~   "
12359|NCT03405038|"~     Catheter colonization, catheter-associated infection and catheter-associated bacteremia are a~     major challenge for resuscitation unit. This study wishes to explore the impact of the~     central venous catheter colonization on the ARDS patient with and without prone position.~   "
12360|NCT03405025|"~     High blood pressure (hypertension) causes strokes and heart attacks. While most patients need~     long-term treatment with pills, some have a cause which can be removed, curing the~     hypertension. The commonest curable cause is a benign nodule in one of the hormone glands,~     the adrenals. About one in 20 patients have such a nodule, but difficulties with diagnosis,~     and reluctance to proceed to surgery for a bengin condition, limit the number having adrenal~     gland surgery to fewer than 300 per year in the UK. A potential, and exciting, solution to~     this dilemma is to use a momentary electric current to cauterise the nodule (radiofrequency~     ablation), without affecting the rest of the adrenal gland, and avoiding the need for~     surgery. Nodules in the left adrenal gland are easily reached under mild sedation using a~     similar procedure as is standard for investigating stomach ulcers (endoscopy). The study is~     designed to show that this approach (endoscopic ultrasound guided radiofrequency ablation) is~     very safe, and to provide initial evidence that the hormone abnormality is cured.~   "
12361|NCT03405012|"~     This is a 48 week study to explore the pathogenesis of HIV treatment related bone disease by~     using a novel imaging technique, 18F-Fluoride Positron Emission Tomography (18F-PET/CT),~     which measures regional bone formation. The study will include other standard methods (serum~     bone markers and DXA) for comparison. Patients enrolled will have baseline, week 24 and week~     48 assessment, with baseline being the date of replacing tenofovir disoproxil fumarate (TDF)~     in their HIV treatment regimen with tenofavir alafenamide fumarate (TAF), compared to a~     control group continuing TDF. Allocation to change to TAF or continue TDF will be randomised~     to allow an unbiased assessment of bone changes.~   "
12362|NCT03404999|"~     Approaches are needed to help primary-care pediatricians address high blood pressure. This~     study will test whether an electronic health-record-based tool to address high blood pressure~     is feasible and improves the evaluation and management of high blood pressure in clinical~     practice. If successful, this approach can be used to address other lifestyle-related and~     complex health problems (e.g., dyslipidemia and diabetes), then disseminated and used~     nationwide.~      The investigators have developed a new, electronic health-record (EHR)-based tool that is~     designed to help pediatricians:~        1. IDENTIFY AND DOCUMENT~             1. when a child's blood pressure is elevated, and~             2. whether it has been elevated before--including number of prior elevations to~               document the correct diagnosis (for example, elevated blood pressure, vs.~               hypertension stage 1, vs. hypertension stage 2), THEN~        2. ORDER the next action(s) needed per guideline-based recommendations, AND per prior~          actions taken--including:~             1. laboratories and studies per 2017 updated guidelines~             2. follow-up interval in primary care~             3. referral to nephrology, when indicated, and~             4. patient education on diet/lifestyle modification.~      The investigators are working on improving this system further with addition of orders for:~        1. referral for sleep-apnea testing and treatment, when indicated, and~        2. blood-pressure medications (for example, initiation, titration, or addition of agents~          depending on blood-pressure control, comorbid conditions [e.g., diabetes], and risk for~          pregnancy)~   "
12400|NCT03404505|"~     This study is being done to examine the feasibility and impact of the Infant Achievements~     caregiver coaching treatment on caregiver child-engagement strategies used during play with~     their infant. The investigators will examine effects on infants' social and communication~     behavior. This randomized controlled trial will compare caregivers and infants in the Infant~     Achievements (IA) coaching group to caregivers and infants in the Caregiver Education (CE)~     no-coaching group. A total of 64 eligible participants (16 children plus their caregiver per~     group) will participate in the study.~   "
12363|NCT03404986|"~     The prevalence of urolithiasis is steadily increasing with an estimation of 1 out of 11~     people in the United States. The prevalence of calculi in Afro-Asian region including Arab~     Republic of Egypt ranges from 4% to 20%. Ureteroscopy is one of the first line treatments for~     definitive management of ureteric stones. Conventional ureteroscopy relies on intraoperative~     fluoroscopy for visualization and guidance, exposing the patient, surgeon and operating room~     staff to ionizing radiation. To minimize the hazards of ionizing radiation there has been a~     trend toward radiation free alternative imaging modalities . Ultrasound provides an excellent~     alternative for upper urinary tract imaging because it is radiation free, rapid, portable and~     allows excellent visualization of the renal pelvis and calyces. There is increasing awareness~     and concern about the clinical use of ionizing radiation and the need to decrease exposure of~     patients and medical professionals. Ultrasound guided ureteroscopy in pregnant females and~     children- in whom fluoroscopy is to be minimized or avoided when possible - has been~     reported.~   "
12364|NCT03404973|"~     The overall goal of the Parkland-UT Southwestern Population-based Research Optimizing~     Screening through Personalized Regimens (PROSPR) is to optimize colon cancer screening~     through personalized regimens in our integrated safety-net clinical provider network, which~     serves a large and diverse population of under- and un-insured patients in Dallas.~      Together, three research projects will assess clinic, system, and organizational factors~     associated with over-, under- and guideline-based screening among this important population~     and will compare benefits, harms, and costs of strategies for facilitating optimized~     screening regimens. Our theme of optimizing colorectal cancer screening in a safety-net~     clinical provider network brings together several components. Its focus on colorectal cancer~     (CRC) screening which is important, because CRC is the second cancer killer in the US while~     being the only major cancer for which optimized screening results in primary prevention.~     Despite this strong potential benefit, CRC screening remains suboptimal overall, and~     especially among low-income and minority individuals served by safety-nets. Safety-net~     networks therefore offer tremendous potential for CRC prevention and control, but numerous~     factors at the clinics-, system-, and organization-level influence their ability to provide~     optimized care.~   "
12365|NCT03404960|"~     The main purpose of this study is to look at the effectiveness, safety, and anti-tumor~     activity (preventing growth of the tumor) of the drugs Niraparib with either Ipilimumab or~     Nivolumab on patients and their pancreatic cancer.~   "
12366|NCT03404947|"~     This study will investigate how ethanol (pure alcohol) influences carbohydrate and fat~     metabolism during prolonged, moderate intensity exercise. Participants will perform two bouts~     of cycling exercise with or without prior ingestion of ethanol, in a randomised order,~     separated by one week.~   "
12367|NCT03404934|"~     In colorectal surgery, hand suturing and stapling are routine methods for performing~     intestinal anastomoses, and these methods appear to be similar in terms of clinical safety.~     Despite several years of experience with surgical procedures as well as improvements to the~     medical devices, problems with disturbed anastomotic healing leading to leakage and stenosis~     after colorectal surgery remain a significant challenge for surgeons. A frequency of~     anastomotic leakage after stapling or suturing has been reported to range from 3% to 20%. In~     addition, preoperative radiotherapy has been shown to increase the risk of anastomotic~     leakage even further.~      The methods that are used today to detect leakages are unfortunately inaccurately and limited~     to monitoring symptoms, temperature, CRP-levels, and performing abdominal examinations and~     CT-scans. These clinical signs and parameters usually become apparent several days after~     onset of the leakage, which leads to a delayed diagnosis. Anastomotic leakage is not only a~     significant cause of increased morbidity of complications and mortality in patients, but also~     associated with increased risk of local recurrence and poor prognosis. Moreover, when~     reoperation is required to fix the leakage, a permanent stoma may be made at the level of the~     sigmoid colon and this procedure impacts live quality of patients negatively.~      Based on the above considerations, a novel, adaptive anastomotic method has been developed by~     CarpoNovum to achieve a safer anastomosis. The method's working name is C-REX Ring-locking~     Procedure. C-REX is referred to our Colorectal anastomotic rings for Re-join the intestinal~     ends and validate the anastomosis, with function of Extract samples for analysis and conduct~     X-ray through connected catheters.~      The novel adaptive anastomotic medical devices, C-REX LapAid and C-REX DMH/DMHC are easy to~     use, with unique possibility to control the anastomosis during and after surgery. The~     previous successful preclinical study encourages a clinical verification in patients~     undergoing colonic resection to evaluate the safety and performance of C-REX Ring-locking~     Procedure by use of C-REX LapAid and C-REX DMH/DMHC.~   "
12368|NCT03404921|"~     To evaluate the efficacy and safety profile of endoscopic submucosal tunnel dissection for~     superficial esophageal squamous cell carcinoma.~   "
12369|NCT03404908|"~     Comparison of two types of analgesia after cesarean section All patients will be anesthetized~     with spinal technique. Ultrasound-guided transversus abdominis plane or quadratus lumborum~     block to treat postoperative pain. Postoperative pain will be measured with visual-analog~     scale (VAS). 1, 2, 6 months after surgery each patient will be called to assess neuropathic~     pain with Neuropathic Pain Symptom Inventory (NPSI).~   "
12370|NCT03404895|"~     The purpose of this study is to evaluate whether placing stent(s) for a blockage in a leg~     vein will help improve the healing of diabetic foot ulcers (DFU). The investigators know from~     having taken care of many patients with diabetic foot ulcers that it is a major cause of~     disability and amputation. These diabetic foot ulcers frequently heal slowly or not at all.~     They sometimes become infected and require antibiotic therapy, debridement and amputation.~     The investigators normally take care of a diabetic foot ulcer with a combination of local~     wound care, surgical debridement if necessary, antibiotics if there is an infection, and~     reduction of pressure on the area of the foot with the ulcer. The investigators observed that~     some patients with a diabetic foot ulcer also have a blockage in a major leg vein referred to~     as the iliac vein. This blockage in the iliac vein prevents the proper flow of blood from the~     leg. This blockage results in pressure within the leg veins leading to swelling in the legs~     which may also prevent healing of the diabetic foot ulcer. This study will investigate~     whether placing stent(s) to treat the blockage(s) will improve healing of the diabetic foot~     ulcer and reduce some of the complications associated with a diabetic foot ulcer. The results~     of this study could result in a new treatment that will allow future patients with diabetic~     foot ulcers to heal better. Right now, placing stents for these blockages in the iliac vein~     is not the standard of care treatment for a diabetic foot ulcer. In order for us to determine~     whether stent placement is helpful, the researchers will have to randomize each patient. In~     other words, to reduce bias, patients will be assigned either to a group receiving a stent or~     to a group not receiving a stent. Every patient in both groups will receive the standard of~     care for a diabetic foot ulcer and undergo an x-ray with contrast and intravenous ultrasound~     examination of the legs. The standard of care for a diabetic foot ulcer may include local~     wound care, antibiotic therapy, debridement and/or amputation, and pressure offloading in the~     foot.~   "
12384|NCT03404713|"~     There are limited evidence-based treatments for adolescents with binge eating and fewer~     specifically targeting adolescents with both binge eating and overweight/obesity. The~     existing research for adolescents with overweight/obesity and loss of control (LOC) eating~     supports a stepped-care model of treatment in which enhanced behavioral weight loss treatment~     is the first line of treatment followed by more intensive therapeutic treatment for~     individuals with remaining emotional eating difficulties. Thus, in this proposed study, the~     investigators will systematically develop a stepped-care protocol and manualized~     interventions for adolescents with LOC and binge eating behaviors. The investigators will~     then evaluate the feasibility and acceptability of the interventions in a pilot trial and~     gather preliminary outcome data to inform development of a subsequent randomized controlled~     trial.~   "
12371|NCT03404882|"~     The aim of the project is to conduct a four arm randomized controlled pilot trial to evaluate~     the effectiveness of an innovative peer support program that incorporates leadership~     training, mentorship, recognition, reward systems and supportive/reminder text messaging for~     patients discharged from acute (hospital) care. Methods and analysis: This is a prospective,~     rater-blinded, three arm randomized controlled trial. 180 patients discharged from acute~     psychiatric care in Edmonton, Alberta, Canada will be randomized to one of four conditions:~     treatment as usual follow-up care, enrollment in usual follow-up care plus daily~     supportive/reminder text messages, enrollment in a peer support system plus daily~     supportive/reminder text messages or enrollment on a peer support system without daily~     supportive text messages. Patients in each group will complete evaluation measures (e.g.,~     recovery, general symptomatology, functional outcomes) at baseline, six months, and 12~     months. Service utilization data and data regarding the experience of the peer support~     workers will also be collected. Data will be analyzed with descriptive statistics, repeated~     measures, and correlational analyses. We hypothesize that patients enrolled in the peer~     support system plus daily supportive/reminder text messages condition will achieve superior~     outcomes in comparison to other groups. Peer support worker experience will be derived from~     exploratory data analysis.~   "
12372|NCT03404869|"~     Study of ORL-1F in Patients With CDG-Ib~   "
12373|NCT03404856|"~     Study of ORL-1G in Patients With Glycogen Storage Disease Type 14~   "
12374|NCT03404843|"~     Previous work demonstrates that the red blood cells of older adults do not release a potent~     vasodilator (ATP) as well as the red blood cells of younger adults. The investigators are~     targeting a pathway within the red blood cell using fasudil hydrochloride to determine if~     both the release of ATP from red blood cells and blood flow responses to low oxygen (hypoxia)~     and exercise in older adults can be improved.~   "
12375|NCT03404830|"~     Due to the high incidence of falls in the elderly population, this study is presented as a~     method to reduce the risk of falls through a specific type of training in people over 60~     years of age.~   "
12376|NCT03404817|"~     This is a study of EMB-001 (a combination of two FDA-approved drugs, metyrapone and oxazepam)~     in healthy adults.This is a Phase 1, single dose, 3-period, 3-sequence, crossover study in 9~     healthy male and female (not of childbearing potential) volunteers. The study will evaluate~     the bioavailability and food effect of a new formulation of EMB-001 relative to the original~     formulation of EMB 001.~      During the study, a total of 9 eligible subjects will be randomized in a 1:1:1 ratio to each~     of 3 treatment sequences~   "
12377|NCT03404804|"~     Our primary objective is to demonstrate the feasibility of utilizing a novel penicillin~     allergy questionnaire in the PED to identify a low-risk group of patients who will complete~     an oral challenge in the PED to test for an IgE-mediated allergic reaction. This project will~     begin as a single site feasibility study, however including up to 2 other collaborative sites~     for enrollment has been favorably discussed. We do not anticipate this to be a single IRB~     scenario and will submit a timely comprehensive amendment if plans become concrete and the~     initial data here proves reliable.~      Our secondary objective is to examine whether health care outcomes and prescription-related~     costs are comparable between children who are de-labeled as penicillin allergic after an oral~     challenge compared to a standard of care group who are not challenged in the PED.~   "
12378|NCT03404791|"~     The purpose of this study is to determine if TAR-200, an investigational drug-delivery~     system, is safe and tolerable in patients with muscle-invasive bladder cancer (MIBC) who are~     unfit for radical cystectomy (RC) during an 84-day induction period comprised of four~     consecutive 21-day dosing cycles.~   "
12379|NCT03404778|"~     This study is a multicenter, prospective, non-randomized, non-controlled clinical outcome~     study. The primary objective of this study is to evaluate improvement of pain score at one~     year for the Biomet Comprehensive Reverse Shoulder. The secondary objective is collection of~     long term clinical outcomes.~   "
12380|NCT03404765|"~     The prevalence of older people with cognitive decline is increasing since the aging~     population is growing substantially worldwide. Cognitive impairment places older adults at~     high risk for functional disability. Previous researches have provided strong evidence on the~     beneficial effects of physical exercise on maintaining cognitive functions in older adults.~     Tai Chi is considered as a low to moderate intensity exercise, which is performed in a slow~     and rhythmic movement. It is a popular and safe exercise suitable for older people who have~     weaker muscle strength. The aim of this study was to determine the effects of Tai Chi on~     cognition and instrumental activities of daily living (I-ADLs), and health-related quality of~     life (HRQOL) in older Chinese adults with mild cognitive impairment (MCI).~      The research hypothesis of the study stated: There is significant improvement in the general~     cognitive performance, functional capabilities of instrumental ADLs,the physical component~     and mental component of HRQOL between the group of community-dwelling older people with MCI~     who have participated and the control group who have not participated in the Tai Chi program.~   "
12381|NCT03404752|"~     This is a randomized, multicentre, Phase 3 study. Patients will be randomly assigned to the~     Study drug or its comparator. The study will be blinded for the staff members in charge of~     the endpoint assessment.~   "
12382|NCT03404739|"~     Peroral endoscopic myotomy is a novel, promising endoscopic technique for achalasia~     considering its minimal invasive characteristics and comparable efficacy to Heller myotomy.~     Numerous studies have focused on the efficacy, safety as well as technical aspects of POEM.~     However, few efforts have been made to the issue of antimicrobial prophylaxis in POEM.~     Postoperative prophylactic antibiotics are universally initiated on call to the operating~     room or at the start of POEM and consist of second-generation cephalosporins. The mean~     duration of antibiotic regimen after POEM was 3 days ranging from 1 day to 7 days.~      Numerous studies have shown that a single dose of antibiotic prophylaxis in a variety of~     surgical procedures. Other studies have shown that prolonged administration of antibiotics~     for longer than 24 hours add no benefit in many surgeries. Prolonged use of antibiotics not~     only increases the costs and exposure to drug toxicity directly but also may be associated~     with an increased risk of acquired antibiotic resistance as well as infection with~     Clostridium difficile.~      Thus, investigators intend to perform a prospective randomized study to confirm the validity~     of single-dose antimicrobial prophylaxis for the prevention of infectious complications~     following peroral endoscopic myotomy.~   "
12385|NCT03404700|"~     Recent epidemiological studies show that egg consumption is associated with insulin~     resistance and altered glycemic control. For this study, the investigators hypothesize that~     this association is due to dietary patterns associated with egg consumption, such as~     saturated fat, and not the consumption of eggs per se. This study will be conducted in two~     parts that will be conducted simultaneously. Part I will utilize an ecological momentary~     assessment approach in which dietary patterns associated with egg intake will be determined~     using an objective measurement of food intake called remote food photography method. In Part~     II, a randomized partial crossover study will be conducted on the same sample of subjects to~     test the effects of egg consumption, saturated fat consumption, and consumption of the~     combination of eggs and saturated fat on glucose, insulin, and hunger and satiety hormone~     levels.~   "
12386|NCT03404687|"~     The presence of an adnexal mass is a frequent reason for a woman to be referred to a~     gynaecologist. The discrimination between benign and malignant adnexal masses is central to~     decisions regarding clinical management and surgical planning in such patients. Patients with~     malignant tumours should be referred to a gynaecological oncologist, as the quality of~     cytoreductive surgery and surgical staging/lymph node dissection are important prognostic~     factors in ovarian cancer. These specialized surgical procedures require the specific skills~     and experience provided by gynaecologic oncology surgeons. Furthermore, appropriate and~     timely referral to a gynaecologic oncologist has been proven to increase survival in patients~     with ovarian cancer.Conversely, patients believed to have a benign mass requiring surgery are~     able to have this performed by a general gynaecologist. A standardized method for~     preoperative identification of probable malignant masses would allow optimization of~     first-line treatment for women with ovarian cancer. A risk of malignancy index would be~     valuable for the selective referral of relevant patients to specialized oncology centres.~     Currently, clinical examination, ultrasound assessment, and assays of tumour markers are part~     of the standard work-up for an adnexal mass. Although none of these indicators alone is very~     sensitive or specific for detecting malignancy, an index developed by Jacobs et al.~     incorporates information about the patient's menopausal status and serum Cancer antigen A-125~     levels, and ultrasound characteristics of the mass to predict the risk of malignancy with~     greater sensitivity and specificity than any one factor alone.Some of the potential~     advantages of risk malignant index include rapid triage of patients through the referral~     system and fewer operations for benign masses being performed by gynaecologic oncologists.~   "
12387|NCT03404674|"~     This study will evaluate the safety of CssBA ± dmLT given by intramuscular (IM) injection.~   "
12388|NCT03404661|"~     The purpose of this study is to develop a test for detection of pancreatic cancer by looking~     at the subject's DNA.~   "
12389|NCT03404648|"~     The purpose of this study is to find out if a PET/MR scan in combination with standard MRI~     and CT scans can improve the early detection and treatment of patients with prostate cancer.~   "
12390|NCT03404635|"~     Prospective, multicenter observational study, of the effectiveness of a standard of care~     protocol implemented to enhance home treatment of VTE. Study population will be selected as~     part of usual care as eligible for home treatment. Study personnel will travel to~     participating institutions to qualify the sites, deliver a Powerpoint® lecture to introduce~     the protocol, meet and train site principal investigators, emergency physicians and research~     personnel on the implementation of the protocol as part of usual clinical care, and data~     collection methods for a quality assurance registry with plans to use the data collected in~     this registry in future publications. Follow-up will be 30 days using medical records and/or~     telephone interview to assess for primary outcomes of bleeding or VTE recurrence.~   "
12391|NCT03404622|"~     The aim of current study is to compare the rates of IUCD expulsion and complications in~     immediate post-placental insertion versus delayed IUCD insertion (6-weeks after cesarean~     delivery)~   "
12392|NCT03404609|"~     The purpose of this study is to understand how cortical stimulation affects~     Obsessive-Compulsive Disorder (OCD) symptoms.~   "
12393|NCT03404596|"~     The purpose of this study is to better understand what happens when someone attempts to quit~     smoking.~   "
12394|NCT03404583|"~     The goal of the research project PROMISE is to translate the person-centred care (PCC)~     principles into an eHealth (the use of information and communication technologies for health)~     context. A developed PCC eHealth platform will be used as a tool to identify patients´~     resources to enhance coping and living with their illness by means of a dialog and~     partnership with staff and relatives. The PCC eHealth platform will not replace, but instead~     be used as add on treatment to usual care (guideline directed care).~   "
12395|NCT03404570|"~     This is a pilot exploratory study to evaluate the safety and efficacy of TC-5214 in subjects~     with palmar hyperhidrosis.~   "
12396|NCT03404557|"~     The M2iSH laboratory showed with two previous clinical trials that Crohn's Disease (CD)~     macrophages present i) a defect to control Adherent-Invasive Escherichia coli (AIEC)~     infection related to polymorphisms associated with CD; ii) a CD - specific cytokine secretion~     profile after an AIEC infection and intestinal inflammation dependent; iii) a modification of~     the response of CD macrophages at a basal state and after the AIEC infection. These results~     consolidate the hypothesis of a defect specific to CD macrophages.~      That's why, the primary purpose of this study is to realize a proteomic analysis of~     macrophages of CD patients infected or not with AIEC and to compare them to Ulcerative~     Colitis (UC) patients and healthy volunteers.~   "
12397|NCT03404544|"~     Prospective, randomized and controlled study who will be conducted at Maisonneuve-Rosemont~     hospital with the following objectives:~      To determine if an infusion of carbetocin over 10 minutes will reduce hemodynamic side~     effects, especially the peak of heart rate, in comparison to a rapid intravenous bolus (less~     than 2 seconds).~      To determine if an infusion of carbetocin will reduce the other side effects of duratocin in~     comparison to a rapid intravenous bolus.~      Study plans to enroll 70 adult patients scheduled to undergo elective cesarean delivery under~     spinal anesthesia.~      Half of the patient will receive Carbetocin 100 mcg intravenous as a bolus (less than 2~     seconds) and the other half will receive Carbetocin 100 mcg intravenous infusion over 10~     minutes.~   "
12398|NCT03404531|"~     This project has the potential to improve the implementation science of treatment as~     prevention and pre-exposure prophylaxis uptake as a public health strategy for reducing new~     HIV infections in the United States. The investigators will develop and pilot test an~     intervention that combines messages sent over social media plus a newly developed interactive~     website specifically developed by and for Black/African American and Hispanic/Latino MSM to~     encourage treatment as prevention and pre-exposure prophylaxis use. Findings from this~     research can guide policy guidelines and recommendations for treatment as prevention and~     pre-exposure prophylaxis uptake for high-risk groups.~   "
12399|NCT03404518|"~     Patient's pain level and narcotic requirements will be evaluated after routine outpatient~     Otolaryngology procedures. This will be done by having study participants record their pain~     level and medication usage from home.~   "
12401|NCT03404492|"~     Clinical improvement has been demonstrated after cardiorespiratory rehabilitation in patients~     with pulmonary hypertension. Rehabilitation is therefore now part of the recommendations for~     good practice. However, no data is available to elucidate the mechanism of this improvement:~     an improvement in myocardial reserve or an improvement in peripheral muscular capacity? The~     main objective of this study is to evaluate the difference in right ventricular contractile~     reserve before and after cardiorespiratory rehabilitation during stress ultrasound in~     pulmonary hypertension in 10 patients with pulmonary hypertension.~   "
12402|NCT03404479|"~     The purpose of this study is to evaluate the pain relief effect of Co-administration of~     Diacerein with Celecoxib in patients with knee osteoarthritis compared with single~     administration of each drug.~   "
12403|NCT03404466|"~     The objective of this study is to evaluate the safety and efficacy of Hypidone Hydrochloride~     tablets in treatment of patients with major depressive disorder (MDD) by evaluating the~     change of MADRS total score from baseline to week 6.~   "
12404|NCT03404453|"~     The incidence of difficult airway in paediatric population is up-to date not well described.~     Difficult airway is connected with significant airway-related morbidity and mortality. The~     majority of difficult airway in paediatric patients should be predictable. The aim of the~     study is to evaluate the incidence of difficult airway in paediatric patients scheduled for~     surgery under general anaesthesia and to test the predictability of the set of prediction~     tests to reveal the patients with high risk of difficult airway.~   "
12405|NCT03404440|"~     Meta-analyses involving >4000 subjects with probiotics added to antimicrobial Helicobacter~     pylori eradication therapy in populations with antibiotic resistance have reported a mean~     increase in eradication rate of 12.2%. It is unclear how to translate that result into~     clinical practice.~      To evaluate whether administration of Lactobacillus reuteri plus a PPI without antibiotics~     would eradicate H. pylori infections.~      This was a double-blind placebo-controlled randomized 2 site study of L. reuteri (2 x 108 CFU~     L. reuteri DSM 17938 plus 2 x 108 CFU L. reuteri ATCC PTA 6475) 7 times per day or matching~     placebo plus 20 mg pantoprazole b.i.d. for 4 weeks. Cure was defined by negative 13C-UBT, 4~     weeks after therapy. Sample size was based on obtaining >50% cures to be clinically useful as~     monotherapy.~   "
12406|NCT03404427|"~     The investigator showed that a night of sleep deprivation halved the duration of an~     inspiratory endurance test and that this loss of endurance could be secondary to a lack of~     activation of the pre-motor cortex. However, the inspiratory endurance test is associated~     with a feeling of dyspnea that could lead to premature arrest, and the inspiratory drive is~     complex, both automatic and voluntary. The investigator can reproduce this results on a~     simpler drive.~      During the execution of an exercise involving repeated contractions of the hand it is~     possible to record the activation of the pre-motor cortex corresponding to the phase of~     preparation of the movement. The amplitude of these premotor potentials is proportional to~     the developed motive force.~      The purpose of this study is to assess the impact of sleep deprivation on the muscular~     endurance of non-dominant in healthy subjects.~      Hypothesis: Sleep deprivation causes a decrease in manual motor endurance by decreasing~     cortical pre-motor control.~      Main objective: To compare the motor endurance of healthy subjects after a night's sleep and~     after a sleepless night.~      Secondary objective: To compare the amplitude of premature cortical control at the beginning~     of the endurance test after a night's sleep and after a sleepless night.~   "
12407|NCT03404414|"~     This is a prospective case-control study to compare the usefulness of 18F-FDG PET/MRI with~     that of 18F-FDG PET/CT in detection of functioning pituitary microadenomas.A single dose of~     370 Mega-Becquerel (MBq) 18F-FDG will be injected intravenously.Visual and semiquantitative~     method will be used to assess the PET/MRI and PET/CT images.~   "
12408|NCT03404401|"~     The objective of this study is to compare the safety and efficacy of BLI4700 bowel~     preparation to an FDA-approved bowel preparation as 2-day, split-dose bowel preparations~     prior to colonoscopy in adult patients.~   "
12409|NCT03404388|"~     Although neurorehabilitation is the most promising clinical strategy for motor recovery in~     patients with multiple sclerosis (MS), treatment responsiveness and outcomes are mixed.~     Neurorehabilitation drives neuroplasticity, i.e., the brain's ability to form and reorganize~     synaptic connections, and involves learning new motor skills, such as standing or walking.~     Initial stages of learning motor skills often require explicit concentration on the details~     of the movement. As one becomes more proficient in the motor skill, it becomes less~     attention-demanding and more automatic. Among healthy adults, the cerebellum mediates the~     shift from early to automatic stages of learning, while animal work shows that brain~     myelination is essential for learning new motor skills and a recent human trial shows that~     task-specific motor training can improve myelin integrity. MS leads to demyelination that can~     affect both the cognitive domains required for this learning process as well as parts of the~     brain that may be required for the automatic execution of motor skills. Although individuals~     with MS are capable of learning new motor skills, not all individuals with MS achieve the~     automatic stage of learning, which is critical for successful rehabilitation. Thus, there is~     a critical need to identify both clinical and structural brain factors predictive of a shift~     from early to automatic learning in persons with MS.~      Specific Aims:~      Therefore, the aims of this study are to:~        1. Identify relationships among brain structures and motor skill acquisition.~        2. Identify relationships among clinical markers and motor skill acquisition.~      To achieve these aims, 72 ambulatory persons with MS will participate in a baseline 3T MRI as~     well as clinical testing of cognitive processing speed. All participants will be trained for~     4 days on a challenging balance program (i.e., motor skill learning) that mimics dynamic~     postural training performed during neurorehabilitation to target high-level balance in~     individuals with neurologic disorders. Briefly, participants will shift their weight to move~     a cursor on a screen to a target. Throughout the training blocks, individuals will receive~     online cursor feedback and will be guarded by a trained study team member to ensure safety.~     To examine the shift from cognitive to automatic learning, participants will be evaluated~     before and after training on their ability to perform a cognitive working memory task while~     performing the dynamic balance shifting (i.e., dual-task performance). The diminishing cost~     of dual-task performance can be used as an index for automaticity and will serve as the~     primary outcome measure for this study.~      Secondary outcomes include changes in clinical balance performance on the Berg Balance Scale~     and changes in single-task performance (i.e., ability to perform the dynamic balance shifting~     task alone or the working memory cognitive task alone).~      At the completion of the proposed research, our expected outcomes are to have identified key~     predictors of motor in persons with MS that influence neurorehabilitation responders (i.e.,~     those who reach the automatic stage of learning) and non-responders to a challenging~     balance-training program. We anticipate that a) brain myelin of the corticospinal tract and~     axonal integrity of the superior cerebellar peduncles will mediate motor skill acquisition~     leading to a shift from early cognitive learning to automatic learning; and b) higher~     cognitive processing speed, which is impacted by demyelination, mediates motor skill~     acquisition, leading to improved task automaticity.~      The objective of this work is to understand factors, both clinical and neuroimaging measures,~     that may influence motor skill acquisition and therefore success with rehabilitation.~   "
12410|NCT03404375|"~     Postpartum hemorrhage (PPH) is the leading cause of maternal mortality in low-income~     countries and the primary cause of nearly one quarter of all maternal deaths globally.~     Estimates of blood loss at delivery are notoriously inaccurate, with under-estimation more~     common than over-estimation. Traditionally, the surgeon performing the cesarean section would~     estimate the blood loss by visually assessing the blood collected in the surgical drape and~     counting the number of lap sponges used thru out the procedure. The investigators would like~     to study and validate an FDA approved device called the gauss Triton device used to estimate~     blood loss during scheduled cesarean sections.~   "
12411|NCT03404362|"~     The objective of this trial is to collect and compare safety and effectiveness data of~     Magnetic Resonance guided Focused Ultrasound (MRgFUS) using the ExAblate 2100 device and~     radiotherapy in the treatment of metastatic bone tumors.~      This study is designed as a prospective, double arm, randomized study with External Beam~     radiation therapy (EBRT) serving as control arm.~      The study hypothesis is that MRgFUS is an effective non-invasive and safe treatment for the~     palliation of metastatic bone tumors with a low incidence of co-morbidity as compared to~     EBRT.~   "
12412|NCT03404349|"~     Approximately 13%-20% of children living in the United States experience a mental health~     problem in any given year. Youth with mental illness have difficulty in social settings and~     have poor academic performance that place them at risk for increased stress and poor mental~     health outcomes. Stress typically manifests as depression, anxiety, or behavioral issues that~     lead to increasingly complex treatment with psychotropic medication. It would follow that~     reducing stress may be a way to improve psychological well being, prevent poor mental health~     outcomes, and hopefully avoid the need for psychotropic medication. Mindfulness teaching is a~     potentially powerful tool for adolescents because it focuses on reducing stress. Thus far,~     studies have not engaged adolescents in developing a patient-centered approach to mindfulness~     Interventions. The current project would be a significant contribution to clinical practice~     and the scientific evidence for mindfulness interventions. This research targets~     psychological well-being within a vulnerable adolescent population that is generally~     underrepresented in research. The research outcomes will be useful to healthcare providers,~     educators, and parents/families in encouraging optimal outcomes for adolescents. The overall~     goals of this proposed research project are to develop and assess the feasibility of an~     adolescent-developed mindfulness intervention.~   "
12413|NCT03404336|"~     Chronic migraine is a disabling type of migraine and is often resistant to treatment.~     Non-pharmacological interventions have been investigated as potential treatment although,~     unfortunately, the literature on their efficacy is poor and showed mixed results. Well-Being~     Therapy (WBT) is a brief psychotherapy which has shown efficacy in decreasing the relapse~     rates of depression in adults, in generalized anxiety disorder and in cyclothymia. It can be~     implemented to empower psychological well-being. The aim of the present study is to test the~     efficacy of WBT in a sample of patients with chronic migraine to verify if it reduces the~     disability due to migraine and distress, it increases the psychological well-being as well as~     the level of euthymia.~   "
12414|NCT03404323|"~     The purpose of the study is to evaluate retinal thickness change and the occurrence of~     central structural retinal changes after uneventful small-incision cataract surgery in eyes~     with asymptomatic early stages of epiretinal membrane.~   "
12415|NCT03404310|"~     The Human Papillomavirus (HPV) is well established as the primary causative agent in both~     warts and cervical cancer. Although cervical high risk HPV (hrHPV) infections have a high~     rate of spontaneous resolution this takes time and the infection can cause cervical cells to~     progress to precancerous and cancerous lesions. Zinc has been shown to play a central role in~     immunity. This study is to determine if oral zinc sulfate can improve clearance rates of high~     risk HPV versus placebo.~   "
12416|NCT03404297|"~     The efficacy of locally sourced compression therapy in the management of chronic leg ulcers~     and Kaposi Sarcoma in western Kenya will be studied in a rural setting~   "
12417|NCT03404284|"~     This is a mixed methods process evaluation of a programmatic intervention to integrate family~     planning and immunization services at health facilities and through outreach services in Dowa~     and Ntchisi districts of Malawi. The study involved qualitative methods (in depth interviews~     and focus group discussions with service providers, mothers and fathers of infants <1 year,~     and supervisors and program managers) as well as secondary analysis of service statistics for~     family planning and immunization services and of supervision reports.~   "
12418|NCT03404271|"~     The objective of this study is to examine the effects of time-restricted feeding (TRF;~     consuming all calories within an 8-hour period of time each day) and resistance training,~     with or without the addition of the dietary supplement HMB, on body composition, muscular~     performance and physiological outcomes in active females.~   "
12419|NCT03404258|"~     This is a novel preliminary study of biomarkers of pathologic pre-operative pulmonary~     vascular development, elevated pre-operative Pulmonary Vascular Resistance Index (PVRi), and~     complications associated with decreased post-operative pulmonary blood flow in single~     ventricle patients undergoing superior cavo-pulmonary anastomosis (SCPA). The study will~     utilize a combined targeted and untargeted approach to both optimize translation of a~     promising existing biomarker and efficiently identify novel biomarkers and potential~     therapeutic targets in this population.~   "
12420|NCT03404245|"~     Self-management is a key component of successful chronic disease management and patients can~     benefit from learning about how daily activities and treatments relate to their symptoms and~     health status on an ongoing basis. The primary goal of this randomized controlled trial is to~     assess the efficacy of an e-health intervention, OPERAS, which includes two components: 1)~     the use of a newly developed web app to self-monitor symptoms/disease activity and treatment~     use, and help patients identify when a medical visit or treatment change is needed; 2) remote~     activity counselling provided by a physiotherapist, with the use of a wearable device~     (Fitbit) and the app to provide activity level feedback. The app component of OPERAS is~     hosted by the secure network of Arthritis Research Canada.~   "
12421|NCT03404232|"~     The study aim is to show the effectiveness of a hybrid system (DTO) regarding clinical~     outcome and radiological alteration in a single-center prospective setting.~   "
12422|NCT03404219|"~     Social impairment contributes to more severe symptoms, higher rates of hospitalization, and~     increased disability in persons with schizophrenia. In this study the investigators will~     develop a smartphone application and test its impact on improving real-world social~     functioning in persons with schizophrenia. Findings from this study will allow researchers~     and clinicians to better understand ways to improve social skills and social motivation, two~     common problems in the daily lives of persons with schizophrenia. The investigators hope this~     mobile phone-based support application will ultimately contribute to increased access to~     effective treatments for social functioning in this population.~   "
12423|NCT03404206|"~     To compare the duration of analgesic efficacy as determined by the time to rescue medication~     of a single oral dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen~     400 mg (2 x 200 mg tablets) and placebo over 24 hours in subjects experiencing moderate to~     severe post-impaction surgery dental pain.~      To compare the overall analgesic effect (SPID 0-24) of a single dose of naproxen sodium 440~     mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo.~      To compare the overall relief from pain (TOTPAR 0-24) of a single dose of naproxen sodium 440~     mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo.~   "
12424|NCT03404193|"~     The goal of this clinical research study is to learn if venetoclax in combination with~     decitabine can help to control acute myeloid leukemia (AML) or high-risk myelodysplastic~     syndrome (HR-MDS) in newly diagnosed elderly patients or in patient with disease that has~     relapsed (come back after treatment). The safety of this drug combination will also be~     studied.~      This is an investigational study. Venetoclax and decitabine are FDA approved and commercially~     available. Venetoclax is FDA approved and commercially available for the treatment of chronic~     lymphocytic leukemia. Decitabine is FDA approved and commercially available for the treatment~     of MDS. It is considered investigational to use venetoclax in combination with decitabine to~     treat AML or HR-MDS.~      The study doctor can explain how the study drugs are designed to work.~      Up to 160 participants will be enrolled in this study. All will take part at MD Anderson.~   "
12425|NCT03404180|"~     Surgery performed with nerve blocks and sedation may be safer and provide better pain control~     compared to general anesthesia and opioid therapy in high-risk patient populations such as~     elderly and troubled with peripheral vascular disease, diabetes, hypertension, coronary~     artery disease, and chronic obstructive pulmonary disease (COPD).~   "
14697|NCT03374566|"~     The purpose of this study is to investigate the immune responses associated with Epstein-Barr~     virus infections, and to find out the possible immunodeficiency that may be linked to severe~     Epstein-Barr virus infections.~   "
12426|NCT03404167|"~     The trial is to evaluate the pharmacokinetics and safety profiles of the single-dose of~     zoliflodacin in eight healthy male or female subjects ages 18 to 45 years inclusive. All~     subjects will be dosed in the morning of Day 1 in a staggered fashion with a minimum of~     several minutes apart. Each subject will receive a single 4g dose of zoliflodacin (2 x 2 g~     sachets of zoliflodacin) after at least an 8-h fast, which will continue for at least 4 h~     after dosing. Consumption of water will be permitted during the fasting period. Subjects will~     be monitored as inpatients in the Clinical Trial Unit (CTU) up to Day 4 and at the Final~     Visit (Day 8 ± 2). Study duration is approximately 4 weeks with subject participation~     duration up to 10 days (from dosing to final visit). The primary objective of this study is~     to evaluate the plasma PK of zoliflodacin after administration of a single 4-g oral dose~     under fasting conditions.~   "
12427|NCT03404154|"~     The unbalanced estrogen with no progesterone will lead to endometrial thickening .This~     thickening result in endometrial hyperplasia & carcinoma and lead to irregular bleeding~   "
12428|NCT03404141|"~     Prenatal stress is associated with negative outcomes such as postpartum depression,~     prematurity or neurodevelopmental delays.~      The aim of this study is to implement a psychological therapy to reduce stress during~     pregnancy.~   "
12429|NCT03404128|"~     Follow up of the patients at Ghent University Hospital treated with hippocampal DBS for~     refractory epilepsy.~      Endpoints:~        -  Long term evaluation of the effects of hippocampal DBS on seizure frequency and~          cognition~        -  Evaluation of the satisfaction of patients and neurologist regarding the rechargeable~          DBS battery~   "
12430|NCT03404115|"~     A Multi-Center, Phase 2b, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled,~     Clinical Study to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution (0.25% and~     0.1%) Compared to Vehicle in Subjects with Dry Eye Disease~   "
12431|NCT03404102|"~     The intrauterine device (IUD) is one of the most widely used reversible, long-term~     contraceptive methods in the world. But despite all its advantages; discontinuation rate of~     IUD ranged from 9.6% to 37.3 % (according to Demographic and Health Surveys data). In Egypt,~     in 2014, the discontinuation rate of IUD (within 12 months of use) was 14.3%.This study~     explores the differences around this rate in Egyptian university clinic and primary~     healthcare clinic with detailed percentages of possible causes.~   "
12432|NCT03404089|"~     This study evaluate the capacity of the MON4STRAT device for drug monitoring of β- lactam~     antibiotic concentrations in newborns, children, and adolescents admitted in intensive care~     units with a health care-associated infection.~   "
12433|NCT03404076|"~     The study investigates response assessment of gastrointestinal stromal tumors using Dual~     Energy CT (DECT) in patients undergoing targeted therapy with a TKI Inhibitor.~   "
12434|NCT03404063|"~     The main objective of the CIRCULATE project is to compare the clinical outcomes of CardioCell~     administration in treatment of ischemic damages of cardiovascular system with control group,~     who will be treated by the administration of placebo during the sham procedure.~   "
12435|NCT03404050|"~     This study explores the value of a particular community based music and dance movement~     therapy group for older adults with dementia?~      To answer this question, the investigators intend to address the following two sub-questions:~        1. How does participants' use of music and movement change over time?~        2. Did a music and dance movement therapy group improve participants' depressive symptoms?~   "
12436|NCT03404037|"~     To assess the relationship between serum endostatin (ES) and Coronary artery calcification~     (CAC) in type 2 diabetic (T2DM) patients.~   "
12437|NCT03404024|"~     The purpose of this study is to evaluate the safety and clinical efficacy of VM202RY injected~     via transendocardial route using C-Cathez® catheter (Celyad, S.A., Belgium) in subjects with~     AMI.~        -  Stage 1: Evaluation of safety and tolerability of VM202RY injection~        -  Stage 2: Evaluation of safety and efficacy of VM202RY injection~   "
12438|NCT03404011|"~     The aim of this study is to evaluate the acute effect of propylene glycol and glycerol intake~     on cardiorespiratory blood parameters.~   "
12439|NCT03403998|"~     Musculoskeletal (MSK) pain is a common reason to seek medical treatment. Temporomandibular~     disorders (TMDs) are MSK disorders that affect the masticatory muscles, the temporomandibular~     joint, and related structures in the neck and head. Current research showed that people with~     chronic TMDs have structural and functional brain changes that may contribute to chronic pain~     development and maintenance. Therapeutic exercise is a central component in treating chronic~     MSK conditions. New therapies, including exercise, appear to have potential in targeting~     cortical changes to improve clinical outcomes. However, mechanisms of action are not well~     understood, and evidence is limited to a few weak studies and specific populations. Evidence~     from our research group highlights neck exercise as potentially useful in treating TMDs.~     However, we do not yet know how the brains of women with TMD respond to specific exercise and~     whether these changes relate to decreased pain, improved function, and quality of life.~     Evidence linking brain plasticity, pain modulation, and exercise therapy is currently~     limited, and non-existent for people with TMDs. Objectives: In women with chronic TMD pain,~     we will:1) determine the impact of motor control training using visual feedback (MCTF) on~     clinical outcomes such as pain intensity and jaw disability, 2) assess the impact of MCTF on~     brain structure, using diffusion tensor imaging, 3) assess the impact of MCTF on brain~     networks, using resting state functional magnetic resonance imaging, and 4) determine the~     effectiveness of MCTF to restore normal muscular structure, performance and fatigability of~     neck cervical muscles, using electromyographic analysis. Methods: Women with chronic TMD pain~     will be randomized to either an intervention arm or a placebo control group. Women in the~     intervention arm will receive 8 weeks of progressive exercise MCTF of the cervical muscles,~     twice per week. Women in the placebo arm will receive innocuous transcutaneous electrical~     nerve stimulation (turn off). Our primary outcomes will be changes in 1) pain, measured with~     the Visual Analogue Scale, 2) brain structure and networks, measured by fractional anisotropy~     (brain structure) and the blood-oxygen-level dependent signal (brain networks). Outcomes will~     be measured at baseline, after 8 weeks of treatment, and 4 months after treatment ends.~     Results will directly inform and guide clinicians in prescribing more effective interventions~     for women with TMD~   "
12440|NCT03403985|"~     Calcium hydroxide and mineral trioxide aggregate have been used in vital pulp therapy with~     variable outcomes recorded by different study. They will be compared when used for direct~     pulp capping in cariously exposed mature permanent teeth.~   "
12441|NCT03403972|"~     This phase 1 clinical trial is to evaluate the effects of the environmental change in~     intestine by antibiotics on the pharmacokinetic characteristics of simvastatin in healthy~     male volunteers. For change of intestine environment, especially the gut microbiota,~     investigators will administer PO vancomycin for 7 days, tid.~   "
12503|NCT03403166|"~     The present record represents a secondary data analysis of the Dietary Approaches to Stop~     Hypertension (DASH) trial. Study data and specimens were accessed through the National Heart,~     Lung, and Blood Institute (NHLBI) Biologic Specimen and Data Repository Coordinating Center~     (BioLINCC). A global, untargeted, metabolomic profile was used to investigate biomarkers of~     the DASH dietary pattern as well as blood pressure change.~   "
12442|NCT03403959|"~     As a subtype of major depressive disorder, seasonal affective disorder (SAD) or winter~     depression causes severe reductions in both quality of life and productivity and results in~     high morbidity and frequent sick leave (1). SAD is a prevalent disorder with rates as high as~     3-5% in central European countries and 8-10% in Scandinavian countries. In our recent~     screening survey among persons with severe visual impairment or blindness (visual acuity <~     6/60), we found a strikingly high prevalence of SAD of 17 % compared to 8% in the fully~     sighted control group. Persons with maintained light perception had a highly increased SAD~     prevalence of 18 % whereas no light perception (NLP) respondents had an SAD prevalence of 13~     %. Light is unquestionably of great importance in the development and treatment of SAD. It is~     suggested that a reduced retinal sensitivity to light leads to sub-threshold light input to~     the brain and consequently to the development of SAD. The novel retinal non-visual~     photoreceptors, the intrinsically photosensitive retinal ganglion cells (ipRGCs), are~     involved in the regulation of circadian rhythm and mood and their function are in part~     independent of the function of the classical rod and cone photoreceptors which form the basis~     of conscious visual perception. Function of the ipRGCs can be assessed by chromatic~     pupillometry where the sustained pupillary contractions following blue light stimulation~     (PIPR) is the main outcome. In persons with SAD without eye disorder the function of the~     ipRGCs is reduced. We here wish to investigate associations between ipRGC function and SAD~     symptoms, circadian profile and treatment response to light therapy in persons with visual~     impairment.~      Persons with visual impairment (SAD and non-SAD) are assessed for ipRGC function with~     chromatic pupillometry, for seasonal mood variation by interview and questionnaire and for~     diurnal melatonin secretion by saliva analysis summer and winter. In winter SAD participants~     are treated with daily morning bright light for 6 weeks. Reduction in depression scores and~     tolerability is recorded.~   "
12443|NCT03403946|"~     In the presented study, our aim was to compare intubation conditions regarding the modified~     Cormack & Lehane score (CL) between the D-Blade® in indirect laryngoscopy or Macintosh blade~     in direct and indirect laryngoscopy with C-MAC PM® in a simulated setting of a difficult~     airway in human subjects.~   "
12444|NCT03403933|"~     Prospective, monocentric study in open, aimed at evaluating the effects of supplementation~     with calcifediol on left ventricular function parameters in cardiopathic subjects undergoing~     major orthopedic surgery.~   "
12445|NCT03403920|"~     As patients improve on one parametric result, the results on the other parametric may worsen,~     but the total score may not be affected. For this reason, it would be useful to make~     measurements that evaluate all the parameters of the patients. Thus, it would be more~     advantageous to score both pain and symptoms separately, as well as activity limitations.~     Therefore, neck specific surveys are needed to meet this need.~      For this reason, this study was planned to determine the validity of the questionnaire named~     Profile Fitness Mapping Low Back Questionnaire in patients with low back pain.~   "
12446|NCT03403907|"~     This study evaluates the effect of probiotic supplementation in patients with drug-resistant~     epilepsy. All the patients received the probiotic.~   "
12447|NCT03403894|"~     Every year, at the Nice University Hospital, about sixty deliveries take place before 24~     weeks of amenorrhea. The child is not viable because of his extreme immaturity. In most~     cases, a child born before 24 years of age is stillborn, but in about one in three cases, it~     shows signs of life such as heartbeat, breathing, gasps or limb movements.~      With these too small children showing signs of life, three attitudes are possible: doing~     nothing and waiting for this life to stop by themselves, setting up palliative care to ensure~     the child's comfort, or administering a medication to shorten his or her life. The attitude~     to have is not univocal and the feeling of the teams confronted with their management is~     difficult even if the goal of the caregivers is always to act as best as possible.~      The main objective of the study is to describe the clinical state of the child and the~     practices implemented in the birth room at the Nice University Hospital when children showing~     signs of life before 24 weeks of amenorrhea are born.~      The secondary objective is to describe caregivers' experiences, their experiences of these~     situations and attitudes towards children and their parents, and to identify ethical dilemmas~     in these situations.~      This study is an observational cohort study including all births of live children before 24~     weeks of amenorrhea at Nice University Hospital for 12 months. It consists of two parts: a~     quantitative study describing the child's condition and caregiving practices, and a~     qualitative study of caregivers' experiences and the determinants of their attitudes towards~     the child.~      The investigator will coordinate the collection of the data necessary to conduct the~     quantitative study, and then conduct individual semi-directive interviews with each of the~     caregivers present at the birth of the child. The qualitative study will be based on the~     analysis of these interviews.~   "
12448|NCT03403881|"~     Randomized clinical trial that aims to increase physical activity levels in people with~     depression and to evaluate if the increase on PA levels has impact on clinical and biological~     measures.~   "
12449|NCT03403868|"~     Mono-center Study to evaluate different multimodal functional parameter of the right~     ventricle in PAH-patients~   "
12450|NCT03403855|"~     This study will take place in Ottawa, Ontario, and will include 100 patients who are~     receiving tunnelled pleural catheters to treat their symptoms of MPE. The aim of this study~     is to evaluate the effectiveness of the shorter versus longer external length Rocket® pleural~     catheter in managing malignant pleural effusions in terms of patients' self-rated quality of~     life, its ease of use, the incidence of complications, and levels of health care provider~     satisfaction.~   "
12451|NCT03403842|"~     Objective of the study is to compare three different analgesic techniques in patients~     undergoing laparoscopic colon resections: peridural catheter, patient controlled analgesia of~     endovenous morphine and patient controlled analgesia of sufentanil sublingual tablets.~   "
12452|NCT03403829|"~     Up to now, IMRT has largely improved the local control of locally advanced nasopharyngeal~     carcinoma (NPC), leaves the distant metastasis as the main treatment failure modality of~     patients with bulky lymph nodes (especially N3 stage). Although concurrent chemoradiotherapy~     (CCRT) continues to stand as the standard treatment of these patients, the role of adjuvant~     chemotherapy remains controversial due to its relatively severe toxicities and inferior~     compliance. However, our retrospective study of 2D-RT and IMRT era had proved adjuvant~     chemotherapy played key role in N3 NPC patients in terms of reducing distant metastasis and~     improving overall survival. Maintenance chemotherapy of gemicitabine single drug is promising~     with adequate efficacy and moderate toxicities. So we aim to conduct A Phase III Randomized~     Trial of Maintenance Chemotherapy in High-metastatic Risk Nasopharyngeal Carcinoma Patients~     of N3 Stage to evaluate the effectiveness and compliance of gemicitabine as maintenance~     chemotherapy in N3 nasopharyngeal carcinoma.~   "
12453|NCT03403816|"~     This study will determine the effectiveness of a free before-school physical activity~     program, BOKS (Build Our Kids' Success), in increasing objectively measured physical activity~     levels among children in elementary and middle school in 7 schools in Massachusetts.~   "
12454|NCT03403803|"~     The purpose of this study is to investigate if the potential biomarkers identified could be~     used for facilitating the diagnosis and prognosis of patients with glioblastoma (GBM).~   "
12455|NCT03403790|"~     The purpose of this study is to evaluate the safety and effectiveness of quetiapine in actual~     clinical settings.~   "
12526|NCT03402867|"~     This study evaluates the effectiveness of Deep dry needling of active myofascial trigger~     points present in muscles of the neck and shoulder region in orchestral musicians.~   "
12456|NCT03403777|"~     This is a proof-of-concept study to define efficacy of AVELUMAB in patients with multiple~     relapsed/refractory germ cell tumors (GCTs). Data suggest that PD-L1 is overexpressed in~     TGCTs, and PD-L1 expression is significantly higher in GCTs in comparison to normal~     testicular tissue.Patients with low PD-L1 expression had significantly better~     progression-free survival (hazard ratio [HR] = 0.40, 95% CI (0.16 - 1.01, p = 0.008) and~     overall survival (HR = 0.43, 95% CI (0.15 - 1.23, p = 0.040) compared to patients with high~     PD-L1 expression. These data suggest that PD-1/PD-L1 pathway could be a novel therapeutic~     target in TGCTs and that there is strong rationale to inhibit PD-1/PD-L1 signaling in GCTs.~   "
12457|NCT03403764|"~     This study evaluates the potential for a new kind of wellness improvement intervention,~     utilizing the cutting edge model of William Tiller, PhD, material scientist and Stanford~     Professor Emeritus. The Tiller model suggests that through the use of focused human~     intentionality, the investigators can impact many things, one of which is the wellness of a~     population. Prof. Tiller's research found that intention in the form of information can be~     imprinted on a simple electric device, called an Intention-Host Device, or IHD. This device~     then energetically broadcasts (or transmits) this information to the study participants. This~     present study examines what effect an intention broadcasted from an IHD has on well defined~     outcome variables in adult subjects, namely self-compassion, wellness, and awakening in~     adults.~   "
12458|NCT03403751|"~     Phase 2 multicenter study to be conducted in up to 50 qualified participating sites in the~     United States to assess the efficacy and safety of Reltecimod vs placebo in patients with~     abdominal sepsis-associated Stage 2/3 AKI.~   "
12459|NCT03403738|"~     Disaster survivors need freely accessible resources to self-monitor their emotional recovery~     and help them address mental health needs they may develop after a disaster. The~     investigators will evaluate a novel, scalable, and highly sustainable smartphone/web-based~     intervention that is designed to address post-disaster PTSD and depressed mood. The~     intervention, Bounce Back Now, will be tested in a study with 5,000 disaster survivors and~     will be accessible via any internet-connected device (e.g., laptop, tablet, smartphone).~   "
12460|NCT03403725|"~     The purpose of this clinical trial is to identify the highest dose of MEN1309 drug with~     acceptable safety profile and that can be used in patients affected by CD205-positive solid~     tumors and Non-Hodgkin Lymphoma~   "
12461|NCT03403712|"~     Multicenter, randomized, double-blind, double-dummy, parallel group, stratified study~     assessing the safety and describing the efficacy of a single dose of intraveneous (IV)~     fosnetupitant/palonosetron (260 mg/0.25 mg) infusion [test] versus oral~     netupitant/palonosetron (300 mg/0.5 mg) combination [control]; each administered with oral~     dexamethasone prior to initial and repeated cycles of AC chemotherapy in female breast cancer~     patients.~   "
12462|NCT03403699|"~     This study proposes to carefully examine the hypothesis that human inducible pluripotent stem~     cells (iPSCs) can be effectively employed as a future therapeutic option for individuals with~     diabetic retinopathy and macular ischemia. iPSCs will be generated from the peripheral blood~     cells of subjects with diabetes and age matched controls. The human iPSC cells will be used~     to generate mesoderm cells for injection into the vitreous cavity of diabetic rodents and~     primate eyes. The ability of mesoderm cells to generate endothelial cells and pericytes in~     areas of degenerated capillaries will be examined. The human iPSCs will also be used to~     generate hematopoietic CD34+CD45+ cells. The combination of CD34+CD45+ cells derived from~     iPSCs and iPSC derived mesoderm will be examined in combination for their potentially~     beneficial effect to enhance the vessel formation.~   "
12463|NCT03403686|"~     Results from large clinical trials demonstrate a strong association between lipid~     abnormalities and progression of the most common microvascular complication, diabetic~     retinopathy (DR). We found that activation of a master regulator of cholesterol metabolism,~     the nuclear hormone receptors liver X receptors (LXRα/LXRβ), prevents DR in rodent models. In~     this application, we seek to understand the mechanisms responsible for the beneficial effects~     of LXR agonists on retina and on bone marrow (BM) to preserve the function of reparative~     cells while reducing inflammatory cell.~   "
12464|NCT03403673|"~     Major vascular operations put the body under stress. We are trying to find out if the general~     health of a patient and the stress resulting from surgery can lead to the development of~     complications after surgery as well as increase the length of time spent in hospital.~      There is evidence to suggest that patients who are frail have a higher risk of developing~     complications after major surgery.~      Our aim is to ask you simple questions about your physical ability to perform daily life~     activities, assess your general health condition and ask you to do simple tasks such as~     drawing a clock or walking for a short distance to assess your speed of walking. Our main aim~     is to identify a tool that will assist us to identify patients who are at risk of frailty.~   "
12465|NCT03403660|"~     Wearing white coat during hospital rounds has been associated with increased risk of~     colonization and transmission of resistant pathogens. On the other hand, studies have shown~     that physicians' attire affects patients' confidence in their physician and the~     patient-physician relationship. The results of these studies were highly dependent on the~     practice setting, with no data in postpartum patients.~      The objective is to test the hypothesis that not wearing a white coat during physician~     postpartum rounds impact patient-physician communication scores.~   "
12466|NCT03403647|"~     Vitamin D is part of the regular treatment regimen among patients after heart~     transplantation. Due to potential drug-drug interaction between vitamin D and everolmus,~     these patients are in increased risk for increased everolimus metabolism, potentially leading~     to under- immunosupression.~   "
12467|NCT03403634|"~     This trial studies how well celecoxib, recombinant interferon alfa-2b, and rintatolimod work~     in treating patients with colorectal cancer that as spread to the liver. Celecoxib may stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth. Recombinant~     interferon alfa-2b is a substance that can improve the body's natural response and may~     interfere with the growth of tumor cells. Rintatolimod may stimulate the immune system.~     Giving celecoxib, recombinant interferon alfa-2b, and rintatolimod may work better at~     treating colorectal cancer that has spread to the liver.~   "
12555|NCT03402490|"~     The aim of our pilot study is to evaluate the feasibility, acceptance and efficacy of~     motivational interviewing (MI) to support elderly patients with heart failure with preserved~     ejection fraction (HFpEF) in maintaining or starting physical activity (PA).~   "
12468|NCT03403621|"~     Researchers are trying to find out more about the side effects of topical (applied to the~     skin) Pentamidine, to determine if it is safe for use in people. They also want to find out~     if topical use of Pentamidine can help treat hypertrophic scars.~      Pentamidine is a medicine that is currently used to treat certain kinds of infection. It is~     most often given by intravenous (into a vein) or inhalation (through a breathing device).~     This medication is approved by the U.S. Food and Drug Administration (FDA) for use in these~     forms.~      Everyone in this study will receive topical Pentamidine (TP) in a silicone based gel (PCCA~     Pracasil Plus). Topical treatment of Pentamidine is still experimental and has not been~     formally tested for safety or effectiveness in a randomized control trial within the United~     States. The FDA has allowed the use of topical Pentamidine in this research study.~   "
12469|NCT03403608|"~     For patients having a bone or joint infections, with or without device, optimal surgical~     therapy could be sometimes non-feasible, especially in the elderly population. Therefore, a~     medical therapy with oral prolonged suppressive antibiotic therapy (PSAT) seems to be an~     option to prevent recurrence and prosthesis loosening.~      Subcutaneous (SC) administration of injectable intravenous antibiotics as prolonged~     suppressive antibiotic therapy could be a convenient way when oral treatment is not available~     to facilitate ambulatory care, this practice being considered as routine care.~      The aim of this study is to evaluate tolerance and efficacy of subcutaneous administration of~     antibiotics for prolonged suppressive antibiotic therapy in patients having this treatment as~     part of their routine care.~   "
12470|NCT03403595|"~     This is an open-label, non-controlled, non-randomized study to assess the safety and measure~     image-based absorbed dose of 177Lu-EB-PSMA-617 in patients with metastatic~     castration-resistant prostate cancer (mCRPC) who will undergo radioliagnd therapy using~     177Lu-EB-PSMA-617. All patients underwent whole-body 68Ga-PSMA PET/CT for selection and~     accepted intravenous injection with single dose 0.80-1.1 GBq (21.5-30 mCi) of~     177Lu-EB-PSMA-617 within one week, then monitored at 2, 24, 72, 120 and 168 h after~     177Lu-EB-PSMA617 administration with serial whole body planar and SPECT/CT imaging.~   "
12471|NCT03403582|"~     Raspberries are high in several phytochemicals, vitamin C and B vitamins and have been shown~     to be potent antioxidants and anti-inflammatory agents. However, human interventional studies~     reporting the effects of raspberries in obesity, T2DM and associated oxidative stress and~     inflammation are limited. Aims, objectives and methods:~      Aim 1: To assess the effects of raspberries in postprandial glycemia and lipemia following a~     high-fat fast-food style meal challenge versus control group Objectives: to execute this aim,~     the investigators will conduct analyses of serum glucose, insulin and lipids (total~     cholesterol, LDL-cholesterol, triglycerides, VLDL-cholesterol and HDL-cholesterol) at fasting~     (baseline) and at postprandial 1,2,4 hours of high-fat, fast food style breakfast~     consumption. The investigators will also calculate homoeostasis model assessment of insulin~     resistance (HOMA-IR) at these time points using serum glucose and insulin values.~      Aim 2: To assess the effects of raspberries in postprandial vascular functions (blood~     pressure and artery elasticity) and inflammation following a high-fat fast food style meal~     challenge versus control group~      Objectives: to execute this aim, the investigators will measure C-reactive protein (CRP) and~     the following parameters of vascular function associated with CVD at fasting (baseline) and~     at postprandial 1,2,4 hours of high-fat, fast food style breakfast consumption:~        -  systolic blood pressure and diastolic blood pressure~        -  large artery elasticity index and small artery elasticity index~        -  systemic vascular resistance~   "
12472|NCT03403569|"~     The traditional Chinese herbal medicine Triptolide Wilfordii has displayed remarkable effect~     on the treatment of autoimmune diseases such as rheumatoid arthritis. Now that~     immunosuppression therapy has recently become a new strategy for HIV infection, it's~     reasonable to expect the anti-inflammatory effect of Triptolide Wilfordii in HIV infected~     patients. So we designed a randomized, double-blinded, placebo-controlled study to explore~     the efficacy and safety of Triptolide Wilfordii in new-onset HIV infection.~   "
12473|NCT03403556|"~     To assess the efficacy and safety of moderate-intensity rosuvastatin/ezetimibe compared to~     high-intensity rosuvastatin in high atherosclerotic cardiovascular disease risk patients with~     type 2 diabetes~   "
12474|NCT03403543|"~     The significance of this cohort study is: 1) to fully investigate the health status of~     pregnant women and newborn babies in China; 2) explore and verify the risk factors of adverse~     pregnancy outcomes in China;3) scientific basis for improving the management of pregnancy and~     ensuring the health of newborns.~      Measures： an electronic questionnaire for each trimester of pregnancy. Recruitment~     eligibility criteria: (1)pregnant women, (2) pregnant for less than 12 weeks, (3)can use~     mobile phone;~   "
12475|NCT03403530|"~     Study comprises of giving IVIG to half of the septic VLBW preterm neonates along with ongoing~     antibiotics and placebo to the other half. The immunoglobulin will be given for 3 days and~     neonates will be monitored for the results. The data will be analysed on the basis of blood~     culture results and outcome of the patients.~   "
12476|NCT03403517|"~     Background:~      Several randomized clinical trials have shown beneficial effects of pre-operative~     glucocorticoids on post-operative complications.~      Studies on the effects of glucocorticoids on the postoperative recovery after liver-resection~     show significantly lower markers of infection and liver damage, and some studies have shown a~     shorter hospital stay.~      Studies on the effects in the immediate postoperative phase are lacking.~      Methods: Randomized, double-blind, controlled trial evaluating incidence of postoperative~     complications in the immediate postoperative phase (and during admission) after open liver~     surgery. Participants are randomized to either active treatment (methylprednisolone 10 mg/kg)~     or control (8 mg dexamethasone), administered just prior to surgery.~      All patients undergoing open liver resection at our institution are eligible. Included~     patients are stratified according to extent of surgery into minor (<3 segments) or major (≥3~     segments) group.~      Patients in major group participate in Substudy I (markers of endothelial damage).~      Patients operated between January and July 2018 participate in Substudy II (delirium).~   "
12477|NCT03403504|"~     This is an open-label, single Dose, randomised, cross-over study to confirm the~     bioequivalence (BE) of OTR tablet 10 mg and OXYCONTIN tablet 10 mg in a fasted state in~     Chinese subjects with chronic pain~   "
14799|NCT03373227|"~     This phase II, single-center, open-label study will evaluate the comparable efficacy of~     tacrolimus extended release tablets (Envarsus®) to the standard of care (SOC) twice daily~     tacrolimus (Prograf®) dosing regimen post-cardiac transplantation.~   "
12478|NCT03403491|"~     Pilot-scale study to assess the effect of self-monitoring using the patientMpower electronic~     health journal (pMp app) [+digital weighing scales & BP monitor] on outcomes in ambulatory~     haemodialysis patients. Design: prospective, open-label, random order, sham-controlled,~     two-period crossover comparison of the pMp app [+digital weighing scales & BP monitor]~     compared with a sham application (without weighing scales or BP monitor). Duration: 10 weeks~     (usual care run-in for 2 weeks followed by 2 x 4 observation periods).~      Primary objective is to determine the frequency of use of the pMp app [+digital weighing~     scales & BP monitor] in patients randomized to that observation method. Additional objectives~     are to determine the effect of pMp app [+digital weighing scales & BP monitor] on proportion~     of haemodialysis sessions in which ultrafiltration rate is ≤ 10 mL/kg/h and in which~     interdialytic weight gain (IDWG) is ≤ 4% and effect of pMp on pre-dialysis weight and BP,~     medication adherence, compliance with daily recording (of fluid intake, weight, BP) and~     requirement for additional unscheduled dialysis.~      An additional objective is to assess the acceptability and utility of the pMp app in helping~     hemodialysis patients and their healthcare professional caregivers manage their condition~     (assessed from both patient and healthcare professional perspective).~   "
12479|NCT03403478|"~     This is a randomized controlled trial. The present study involves an acute and chronic~     intervention, which is a water-based exercise (one session: to acute intervention; 12-weeks~     of aquatic exercise program: to chronic intervention). The sample will be composed by elderly~     enrolled in university extension program titled Hidroginastica na Terceira Idade~     (Hydrogymnastics in aging). It will be evaluated the effects of water-based exercise on~     hemodynamics, self-reported sleep quality, depressive symptoms, quality of life, body~     composition, level of physical activity and functional capacity. The investigators~     hypothesized that an acute water-based exercise under different intensities promotes~     hemodynamics changes in elderly. In addition, the investigators hypothesized that 12-weeks of~     aquatic exercise may lead improvements in self-reported sleep quality, depressive symptoms,~     quality of life, body composition, level of physical activity and functional capacity in~     elderly.~   "
12480|NCT03403465|"~     This study expands on protocol (NCT01908504PET adaptive RT) designed to evaluate the~     utility of adaptive PET-CT planning for radiation therapy (RT). Radiation therapy is used in~     many malignant diseases as a curative treatment modality. However, critical normal tissue is~     often in close approximation to disease, and portions of such tissue must receive high doses~     of radiation for appropriate treatment.~      Positron Emission Tomography (PET) adapted radiation therapy, as defined in the current~     protocol, may allow for a means of determining the eventual response to therapy, at a time~     point when adaptation of treatment plan may be possible to improve outcomes. This protocol~     will build upon the findings the previous protocol (NCT01908504 PET adaptive RT) that~     evaluated the utility of intra-treatment PET imaging in multiple types of cancers. The~     current focus will be more specific to certain types of gastrointestinal and gynecologic~     cancers treated with RT, identified from the prior study to warrant further research.~   "
12481|NCT03403452|"~     This is an Exploratory Clinical Trial Study on Apatinib in the Treatment of Metastatic~     Colorectal Cancer Who Have Progressed after Standard Second Line Therapy.~   "
12482|NCT03403439|"~     The primary objective of this trial is to investigate whether and to what extent~     co-administration of multiple doses of itraconazole affect single dose pharmacokinetics of~     BI1015550, i.e. to compare the relative bioavailability of 6 mg BI 1015550 when given alone~     (reference, treatment R) to the relative bioavailability of 6 mg of BI 1015550 given on the~     4th day of a 12-day-treatment with itraconazole (test, treatment T) following oral~     administration in healthy male subjects.~   "
12483|NCT03403426|"~     To evaluate the safety and effectiveness of the ReFlow Medical Wingman Catheter used to cross~     de novo or restenotic infrainguinal CTOs that cannot be crossed with a standard guidewire.~   "
12484|NCT03403413|"~     The primary goal of this pilot study is to explore the feasibility of cyclic vibration (CV)~     of the lower extremity muscles to improve walking in individuals with gait deficits from~     multiple sclerosis (MS).~   "
12485|NCT03403400|"~     Dizziness is a common complaint reported by 30% of people above 65 years of age and by more~     than 50% of those 90 years of age and older.(1) Age-related decline in vestibular,~     musculoskeletal, and neurologic performances compounded by a vestibular pathology can result~     to debilitating physical and psychological consequences. Dizziness is associated with~     falls,(2) disability (3) and physical inactivity.(4) Walking for endurance is cited as one of~     the components of vestibular rehabilitation (VR) in the Clinical Practice Guideline for~     Peripheral Vestibular Hypofunction.(5) Although walking can offset the avoidance of physical~     activity from symptom provocation, no direct evidence has been found to support the effect of~     walking on postural and dynamic stability, function, and participation in people with~     dizziness.~      The primary purpose of this study is to evaluate the impact of walking as an exercise~     component of VR on both primary and secondary vestibular-specific outcome measures. The~     primary outcomes are mCTSIB, TUG test, DGI, and DHI, while the secondary outcomes are the~     total number of visits and length of interventions (in weeks). The second purpose is to~     evaluate whether pedometers increase the adherence of older adults with vestibular issues to~     a walking program. This will be measured by change in physical activity, as represented by~     International Physical Activity Questionnaire (IPAQ) Walking Metabolic Equivalent of Task~     (MET)-minutes/week and IPAQ Total Physical Activity MET-minutes/week scores from the IPAQ~     short form during the episode of care (admission and discharge) and on four-weeks follow-up~     compared to those patients who only received instructions to walk without a pedometer. The~     third purpose of this study is to establish test-retest reliability of the TUG test on older~     adults with dizziness. Lastly, the fourth purpose of this study to investigate if the TUG,~     DGI, and mCTSIB are significant and strong predictors of the DHI in older adults with~     dizziness.~   "
12486|NCT03403387|"~     This study evaluates the effects of combination probiotic, prebiotic, and enzyme~     supplementation on the colonic microbiome of individuals with GI symptoms (e.g. diarrhea,~     constipation, increased gas). Half of the participants will receive the placebo while the~     other half will receive the supplement for 28 days.~   "
12487|NCT03403374|"~     To describe the safety and tolerability of Repatha in subjects with homozygous familial~     hypercholesterolemia (HoFH) in India. All subjects will receive Repatha over an 8 week~     period.~   "
12488|NCT03403361|"~     The aim of this protocol is to refine the accuracy of proton beam therapy (PT) by the use of~     dual energy computed tomography (DECT), in conjunction with novel iterative image~     reconstruction algorithms, to more precisely determine the tissue properties through which~     the proton beam path travels.~   "
12489|NCT03403348|"~     The purpose of the study is to evaluate the safety and tolerability of single and multiple~     oral doses of JNJ-64417184 administered to healthy participants and the antiviral effect of~     multiple oral doses of JNJ-64417184 compared to placebo in participants infected through~     inoculation with respiratory syncytial virus (RSV)-A Memphis 37b (Part 4).~   "
12490|NCT03403335|"~     A newly developed intervention, Mindfulness Based Practices for Health Care Professionals in~     Training: Clinical Applications, will be piloted to determine the feasibility and~     accessibility within this population. The purpose of the proposed study is to assess the~     change in perceived stress at work/school and psychological symptomology; i.e., depression,~     stress, emotion regulation, and dispositional mindfulness, from pre to post intervention in~     health care professional students and when compared to a matched control group.~   "
12491|NCT03403322|"~     Children with Cerebral Palsy (CP) present limited performance of functional activities and~     activities of daily life. Kinesio taping has been definied as a promising technique for~     children with CP ans has been extensively used in clinical practice. However, several studies~     have found a low level of evidence of its effectiveness in healthy individuals. We aim to~     evaluate the effects of the immediate application of Kinesio taping on the activation of the~     rectus femoris and anterior tibialis muscles and on the duration of sit-to-stand movement in~     children with CP.~   "
12492|NCT03403309|"~     A purpose of the present study is to investigate the capability of serum uric acid elevation,~     safety, and tolerability of inosine 5'-monophosphate in patients with multiple system atrophy~     with multicenter, randomized, placebo controlled, parallel assigned design. This may provide~     the cornerstone for future extended trial in multiple system atrophy, a debilitating disease~     to date.~   "
12493|NCT03403296|"~     The purpose of this study is to validate a pre-defined single-patient classifier algorithm~     for predicting prognosis and benefit from adjuvant chemotherapy for patients who underwent D2~     gastrectomy for stage II and III gastric cancer. This algorithm classifies gastric cancer~     into five groups according to its molecular characteristics based on RNA expression levels.~     The prognosis and response from adjuvant chemotherapy will be different according to~     prognostic and predictive clusters respectively based on these groups, thus this algorithm~     can identify as patients which will have benefit from adjuvant chemotherapy or which will~     not. Consequently, this algorithm can be translated into clinical practice to help doctors~     who decide the necessity of adjuvant chemotherapy after D2 gastrectomy for patients who had~     diagnosed stage II and III gastric cancer.~   "
12494|NCT03403283|"~     The purpose of this study is to determine if the reparative cells of blood vessels called~     endothelial progenitor cells(EPC) are defective in people with diabetes.~   "
12495|NCT03403270|"~     The ENCOURAGE App will use mobile health technology to support employees to reduce their~     sedentary time and become more physically active. The mobile app has been developed using~     time management techniques (i.e. Pomodoro technique) as a strategy to provide prompts to~     encourage users to engage in an activity and break up bouts of prolonged sitting.~   "
12496|NCT03403257|"~     The Mexican American population in the U.S. is rapidly growing and aging. This project seeks~     to determine the prevalence and outcomes of cognitive impairment and dementia in Mexican~     Americans. It also seeks solutions to help patients with cognitive impairment and dementia~     and their caregivers get the resources they need.~   "
12497|NCT03403244|"~     The purpose of this study is to evaluate the feasibility and efficacy of US-MR image~     fusion-guided percutaneous transforaminal endoscopic discectomy for the treatment of lumbar~     disc herniation~   "
12498|NCT03403231|"~     This study will evaluate a VA MyHealtheVet Secure Messaging intervention that uses different~     intervention messaging strategies designed to increase engagement in behaviors to prevent~     type 2 diabetes.~      The investigators will enroll 144 eligible Veterans into a 12-week MyHealtheVet Secure~     Messaging intervention. Eligible Veterans include those who are currently using MyHealtheVet~     secure messaging, meet inclusion/exclusion criteria, and have received an HbA1c test within~     the last 6 months that meets the ADA/CDC classification for prediabetes. Study participants~     will be surveyed about their engagement in behaviors to prevent TDM2 and mediators of this~     engagement. After completing a baseline survey, participants will be randomly assigned to~     receive different novel presentations of information about ways to prevent T2DM through both~     Secure Messaging and US Mail. The investigators will test the 5 presentations that each: (1)~     represent an innovative approach from behavioral economics or health psychology with great~     promise to increase engagement in behaviors to prevent T2DM among patients with prediabetes;~     and (2) have not been tested in this setting.~   "
12499|NCT03403218|"~     This study aim to translate the BESTest and mini-BESTest to Spanish, adapt it and investigate~     its validity in spanish population.~   "
12500|NCT03403205|"~     Wilson Disease (WD) is an autosomal recessive disorder of impaired copper (CU) transport~     caused by mutations in the ATP7B gene. WTX101 (bis-choline tetrathiomolybdate) is a~     first-in-class copper-protein-binding agent with a unique mechanism of action, under~     investigation as a novel therapy for WD. It is formulated as an enteric coated tablet (15 mg~     strength) for oral administration. The purpose of this study is to evaluate the efficacy of~     WTX101 administered for 48 weeks compared to standard of care (SOC) in WD subjects aged 18~     and older.~   "
12501|NCT03403192|"~     The objective of this study is to evaluate the positional stability and quality of lung~     isolation provided by the EZ-blocker compared to a DLT for both right and left sided thoracic~     surgery.~      An additional objective will be to assess time to placement of both devices and other~     significant clinical differences between these two approaches to placement of the BB~     including airway injury and post-operatives sore throat, post-operative hoarseness,~     Additionally we would like to examine the preoperative high resolution CT imaging data to~     determine if there are anatomic landmarks that may potentially inform the appropriateness or~     inappropriateness of choosing an EZ-blocker or left sided DLT.~   "
12502|NCT03403179|"~     Bipolar Disorder is a major mood disorder with periodic mood episodes that may be very~     distressing, both to the individual and to others. When ill, the person is at particular risk~     for disruptions to social and occupational functioning, physical health, and even premature~     death. When not in an episode, individuals with BD may still be feeling well but have ongoing~     neurobiological processes, as well as the psychological sequelae from illness episodes, that~     can lead to subtle neurocognitive impairment that impedes overall functioning. This study is~     a test of an existing, published intervention that ameliorates deficits in functioning in~     euthymic bipolar individuals.~   "
14584|NCT03376035|"~     Our investigators plan to measure the skin on the breast six months after breast~     reconstruction. The non-reconstructed breast will be used as the control for subject with~     unilateral reconstruction only. For those who have BILATERAL reconstruction, a core~     temperature will be obtained from the ear.~   "
12504|NCT03403153|"~     The overall goal of this work is to adapt, refine, and conduct an open trial of a~     parent-training intervention for Veterans with posttraumatic stress disorder (PTSD) symptoms~     using feedback from Veterans, VA clinicians, and expert consultants as key stakeholders. PTSD~     symptoms are associated with parent-child functioning difficulties, which are also an~     important determinant of quality of life and functional recovery. This project will examine~     the feasibility and acceptability of an evidence-based group intervention to improve~     parenting behaviors, parenting satisfaction, and family functioning in Veteran parents with~     PTSD symptoms and who have children between the ages of 3 and 12.~      This intervention is derived from an existing evidence-based intervention to improve Veteran~     relationship functioning (Strength at Home; SAH), and it is informed by the Cognitive~     Behavioral Theory of Interpersonal Functioning and the Military Family Attachment frameworks~     for the association between PTSD and family functioning problems. The intervention also~     includes a pre-treatment Motivational Interviewing Assessment (MIA) to assist Veterans in~     strengthening and building motivation to change their parenting behaviors. The goals and~     change talk identified in the pre-treatment MIA are then referred to throughout the~     treatment. Groups are gender-specific, meaning that the investigators will pilot the~     treatment in separate groups of women and men Veterans.~   "
12505|NCT03403140|"~     The purpose of this study is to asses the long term efficacy, safety and immunogenicity of~     ENERCEPTAN® in combination with Methotrexate for the treatment of patients with rheumatoid~     arthritis up to 104 weeks~   "
12506|NCT03403127|"~     This study will see whether the addition of more frequent planning CTs during the course of~     radiation, and of Positron Emission Tomography (PET), a diagnostic test similar to CT, prior~     to and during a course of radiation may provide information that could potentially be used~     during the treatment to improve the initial radiation plan.~   "
12507|NCT03403114|"~     This study aims to evaluate the perceptions and knowledge of hospital specialists regarding~     vaccine recommendations targeting their patients, to study their behavior with respect to~     these recommendations and to quantify their vaccine hesitancy.~   "
12508|NCT03403101|"~     Pancreatic cancer represents the most lethal of the common malignancies with a 5-year~     survival rate of less than 5%. For patients who are eligible for potentially curative~     resection, despite mortality and morbidity rates after surgery have improved, the recurrence~     rate is up to 85% within 2 years. FOLFIRINOX (fluoropyrimidine/leucovorin plus irinotecan and~     oxaliplatin) has been proved to significantly improve the prognosis and is recommended as~     first line treatment in patients with advanced pancreatic cancer. However, the regimen is~     limited due to the severe adverse effects. Thus, the investigators replaced 5-FU and~     leucovorin in the FOLFIRINOX regimen with oral S-1, a new oral ﬂuoropyrimidine derivative~     which was proved to be the well-tolerated and effectively in large III phase randomized~     clinical trial, to form the SIRIOX regimen. A phase I clinical trial from Japan found that~     SOXIRI (S-1, oxaliplatin and irinotecan) works in patients with advanced pancreatic cancer.~     In this study, the researchers intend to investigate the activity and safety of the~     combination of this regimen in patients with advanced pancreatic cancer.~   "
12509|NCT03403088|"~     This study will compare clinically the efficacy, time to action and duration of different~     treatments for patients with non-carious cervical lesions (NCCLs) that caused dentin~     hypersensitivity (DH).~   "
12510|NCT03403075|"~     To date, studies published on multidimensional rehabilitation programs are addressed to~     patients with different types of cancer and, frequently, these studies only include a limited~     number of patients with blood neoplasms. So, there is no evidence of the effectiveness of~     multidimensional rehabilitation programs in this particular category of patients. A~     systematic review of the effectiveness of aerobic exercise alone, not associated with~     therapeutic education, has recently been conducted in adult individuals with hematological~     malignancies (reference 25386666). The review highlighted the effectiveness of physical~     activity on the quality of life of the target population. However, the medium and long term~     effects that physical exercise have on other clinically relevant endpoints, such as fatigue,~     psychological distress, and physical performance level, remain to be clarified. Thus, it is~     important to investigate the effectiveness of multidimensional interventions that integrate~     physical activity to therapeutic education targeted at the specific needs of individuals with~     blood neoplasm.~      The aim of this study is to evaluate, in blood cancer patients, the feasibility of a~     therapeutic education program associated with physical activity, and to verify its effect by~     a long-term follow-up.~   "
12511|NCT03403062|"~     1. Evaluate the relationship of RDW and severity and mortality in patients with neonatal~          sepsis .~        2. Using RDW as a simple, inexpensive, applicable and rapid test to detect prognosis of~          neonatal sepsis .~   "
12512|NCT03403049|"~     This is a phase I trial to determine the maximum tolerated dose of carbon ion radiotherapy~     for the treatment of locally advanced, unresectable, pancreatic cancer.~   "
12513|NCT03403036|"~     This study will evaluate the safety and efficacy of brodalumab in the treatment of~     moderate-to-severe psoriasis in patients who have previously failed treatment with~     interleukin (IL)-17A therapies. Forty patients will be enrolled in this 16-week open-label~     study. Patients will receive 210 mg of brodalumab subcutaneous injection at weeks 0, 1, and~     2, followed by 210 mg every 2 weeks. The primary efficacy endpoint will be the proportion of~     patients achieving a score of 0-clear or 1-almost clear in the sPGA score after 16 weeks~     of treatment. After completion of the 16-week trial, patients may desire to continue~     treatment with brodalumab.~   "
12514|NCT03403023|"~     Dry Eye Syndrome (DES) is a disease affects the production and stability of the tear film,~     leading to vision disturbances and a major decrease in quality of life. The most recommended~     treatment for moderate-severe DES today which failed conservative therapy with lubricating~     eye drops is topical Cyclosporine 0.05% (Restasis®).~      The Tear Film Imager (TFI) is a novel imaging modality designed for visualization of the~     individual tear film layers up to a resolution of 0.1 micrometers, a property not enabled by~     any other imaging modality for this indication to date.~      In this study we wish to assess the effects of topical Cyclosporine 0.05% on the tear film~     using the TFI. In our previous study we found this modality yields high resolution images of~     the tear film, yielding significant differences between healthy and diseased (DES) eyes. We~     believe the TFI will improve quality of assessment and follow-up of DES patients, allowing~     more effective diagnosis and treatment of this disease in the future.~   "
12515|NCT03403010|"~     The aim of this project is to evaluate the effectiveness of using rehabilitation-specific~     gaming in physical therapy of children with cerebral palsy.~      The primary goal of this project is to evaluate the effectiveness of integrating 15 to 20~     minutes of gaming using a rehabilitation-specific gaming platform into standard physiotherapy~     sessions on the achievement of individual goals of children with bilateral spastic cerebral~     palsy with GMFCS level III-IV.~      The secondary goal of this project is to evaluate the effectiveness of integrating 15 to 20~     minutes of gaming using a rehabilitation-specific gaming platform into standard physiotherapy~     sessions on trunk control and gross motor function of children with bilateral spastic~     cerebral palsy with GMFCS level III-IV.~   "
12516|NCT03402997|"~     The resistivity measurements will be done by introducing a needle-probe into fresh healthy,~     peritumoral, and tumoral ex vivo tissues.~   "
12517|NCT03402984|"~     Introduction. Functional dyspepsia (FD) is a common chronic gastrointestinal disorder with a~     high socio-economic impact. Acotiamide, a new prokinetic agent, was shown to be efficacious~     in the treatment of FD, especially in the postprandial distress syndrome subgroup. To date,~     the exact mechanism of action of acotiamide is incompletely elucidated.~      The aim of this study was to examine the effect of acotiamide on gastric motility, gastric~     emptying rate and gastrointestinal symptom perception in healthy participants in a~     randomized, placebo-controlled, cross-over study design. Participants were treated with~     acotiamide (100 mg t.i.d.) and placebo for 3 weeks, separated by a one-week wash-out period.~     At the end of each treatment period, gastric emptying and motility were assessed on two~     consecutive study days. During gastric motility assessment, epigastric symptom scores were~     collected at multiple time points.~   "
12518|NCT03402971|"~     The main goal is to establish echocardiographic reference values of the right heart for~     pregnant women, assuming they differ significantly from those of non pregnant women of same~     age.~      Therefore the investigators will use existing reference values published by American society~     of echocardiography and European Association of Echocardiography. As side arms the~     investigators want to explore, whether illness of either fetus or mother is connected with~     right heart affection.~   "
12519|NCT03402958|"~     Osteoporosis is a major public health problem. Its screening and its treatment remain largely~     insufficient while therapies have demonstrated their effectiveness. In the event of a severe~     fracture, the update of the 2016/2017 recommendations, prepared by the Research and~     Information Group on Osteoporosis and the French Rheumatology Society, concerning~     osteoporosis recommends a specific treatment with bisphosphonates as first-line treatment,~     without bone densitometry, regardless of age. The frequency of prescribing anti-osteoporotic~     treatment as an outpatient after a fracture of the upper extremity of the femur is very low~     (2% to 21% according to the studies). The main factors associated with non-prescription found~     are co-morbidities (charlson score> 6), dementia, obesity (BMI> 30), chronic alcoholism, male~     sex, polypharmacy> 4, age. Conversely, the factors associated with prescribing are recurrent~     falls (> 2 / year), a history of osteoporotic fracture, an Iso Resource Group> 3, female sex,~     and corticosteroid therapy.~   "
12520|NCT03402945|"~     This vanguard study will be conducted at two study sites in Canada. It is a cluster~     randomized trial to test a combination of two antibiotics for antibiotic prophylaxis as~     compared to routine prophylaxis with one single antibiotic, and to test a negative-pressure~     wound management system (Prevena) versus standard wound dressing to reduce chest wound~     infections.~   "
12521|NCT03402932|"~     The objectives of the current project aim to determine whether a more controlled~     amplification method or a visual administration has an effect on hearing impaired older~     individuals' cognitive test scores.~      Aim 1 is to create a visually administered condition of a cognitive test and to validate this~     condition in comparison to the auditory administration. Data will be collected from younger~     individuals with normal hearing. Each younger individual is tested using both visual and~     auditory condition and the scores are compared across the two conditions. It is anticipated~     that the scores will not be significantly different between the two conditions. Any remaining~     difference in performance will be used for analyzing the data from older participants with~     hearing loss.~      Aim 2 is to examine the test condition effect on cognitive testing results in older~     individuals with hearing loss. The three test conditions include auditory unamplified,~     auditory amplified, and visual. Each older individual will be tested using two different test~     conditions. It is predicted the auditory amplified and visual administrations will alleviate~     the cognitive load associated with hearing difficulty and lead to improved performance on the~     test.~   "
12522|NCT03402919|"~     This is a 5-year observational study recruiting sixteen hundred and fifty individuals between~     the ages of 50 and 90 with different types of dementia as well as a comparison group of six~     hundred and fifty aged matched individuals without cognitive deficits. Participants will be~     recruited at sites across Canada and will undergo assessments and provide biological samples~     at baseline and two years after baseline.~   "
12523|NCT03402906|"~     Spatial neglect may occur in patients who have had a stroke. People with spatial neglect~     often pay much more attention to one side of the body while ignoring the other side, even~     though they have no difficulty seeing. The purpose of this study is to evaluate the impact on~     stroke recovery, including spatial neglect, of the Family-Clinician Collaboration program,~     where a family member of a stroke survivor actively interacts with clinical staff members~     providing inpatient rehabilitation services to the stroke survivor.~   "
12524|NCT03402893|"~     This is a single-center, open label pilot study. The study is comprised of 5 study visits;~     Screening, Baseline, and Weeks 4, 8, and 16. All subjects will receive Onexton at Baseline~     and be instructed to apply the gel once daily to the face. The investigators will evaluate~     Investigator Global Assessment of acne (IGA), total lesion count, inflammatory lesion count,~     non-inflammatory lesion count, Investigator Global Assessment of Post-Inflammatory~     Hyperpigmentation and distribution of Post-Inflammatory Hyperpigmentation, adverse events and~     concomitant medications.~   "
12525|NCT03402880|"~     This phase II trial studies how well pembrolizumab and epacadostat work in combination~     treating patients with extensive stage small cell lung cancer. Monoclonal antibodies, such as~     pembrolizumab, may assist the immune system in recognizing cancer cells leading to~     elimination of those cells. Epacadostat may prevent down-regulation of T-cells, which means~     it can boost the immune system. Giving pembrolizumab and epacadostat together may work better~     than either drug alone in treating extensive stage small cell lung cancer.~   "
12529|NCT03402828|"~     This non-interventional study of real-life clinical practice strategies for long-term relapse~     control in patients with psoriasis vulgaris is planned to enroll 650 adult patients from~     60-100 Russian dermatology sites and follow the patients for up to 52 weeks. The study will~     map actual strategies and focus on patients' and dermatologists' experience with the~     different topicals used, including unspecified products with and without active drugs.~   "
12530|NCT03402815|"~     The investigator tested the efficacy of maraviroc intensification on down-regulating~     atherosclerotic progression in HIV infected patients with optimal viro-immunologic control~     and at high cardiovascular risk.~   "
12531|NCT03402802|"~     The study will monitor how often persons use eye drops that are prescribed after glaucoma~     surgery and will compare the adherence with drop use to the success rate of the surgery.~   "
12532|NCT03402789|"~     This study evaluates the addition of docosahexaenoic acid (DHA) to eye patching in the~     treatment of residual amblyopia in children ages 3 to 18 years old. Two thirds of~     participants will receive DHA along with eye patching, while one third of participants will~     receive a placebo along with eye patching.~   "
12533|NCT03402776|"~     It is recommended for patients who underwent an hematopoietic stem cell transplantation to~     receive 6 months after the graft 3 injections of hexavalent vaccine (diphteria-tetanus-~     poliomyelitis-pertussis-Hib-HBV) within 2 months followed by a booster dose one month after.~     The patients included in the study will have a measure of their antibody level against 5~     pathogens (diphteria toxin, tetanus toxin, Haemophilus influenza b, hepatitis B virus,~     poliomyelitis virus) one month after the 3rd injection of hexavalent vaccine. If the antibody~     response is not sufficient, they will be randomized for a 4th dose in the following month.~     The antibody response will be again measured one month after the 1 year booster dose.~   "
12534|NCT03402763|"~     There is an urgent need to increase advance care planning among older adults in order to~     ensure that patients receive care of the end of life that is consistent with their values and~     preferences. Emergency departments (EDs) provide an opportunity to reach a large proportion~     of older adults who have not yet completed advance care planning at a time when they are~     likely to recognize the need for such planning. The purpose of this pilot is to examine the~     potential of a video-supported intervention initiated during the emergency department visit~     to promote advance care planning.~   "
12535|NCT03402750|"~     The objective of this investigation is to pilot test a medication in-hand intervention (Meds~     to Beds) compared to standard care for patients with heart failure (ICD-50[all numbers]). The~     study will evaluate if the intervention improves adherence and physical health, and reduces~     hospital re-admissions. The study will provide evidence for the feasibility and acceptability~     of the medication-in-hand intervention.~   "
12536|NCT03402737|"~     To derive the maximum tolerated dose of hypofractionated stereotactic body radiotherapy~     (SBRT) using dose painting by numbers with cyclophosphamide in patients that are reirradiated~     for recurrent squamous cell carcinoma of the head and neck.~   "
12537|NCT03402724|"~     Transcatheter Aortic Valve Implantation (TAVI) is became the gold-standard therapy for~     patients with severe and symptomatic aortic stenosis with high operative risk or not suitable~     for surgery.~      All studies assessed TAVI showed excellent results at short and mid-term follow-up. The~     current and future development of the devices predict an extension of indications to~     intermediate-risk and younger patients.~      Therefore, long-term evaluation of these valves is a priority to determine their durability.~      However, standardized echographic follow-up of patients implanted with TAVI is lacking.~      Indeed, there was not consensual definition of TAVI degeneration until now. Recently,~     European Society of Cardiology published echographic criteria to precise and standardized~     TAVI deterioration based on simple hemodynamic and morphological criteria.~      In addition, very few studies have been interested in monitoring more than 5 years of these~     devices.~      Finally, nowadays we did not know if TAVI evolution is the same as surgical bioprosthesis.~   "
12538|NCT03402711|"~     The present study was designed to observe the incidence of bleeding events and~     characteristics of bleeding and exploratively analyse bleeding related biomarkers and gene~     polymorphisms in ACS patients undergoing PCI.~   "
12539|NCT03402698|"~     Prevalence of vitamin D deficiency in children in the northern country during winter season~     is very high (up to 90%). Vitamin D supplementation at a dose 600 -1000 IU/d is recommended~     in Polish children from September till April. However, there is shortage of studies in Polish~     children. The aim of the study is to assess the effectiveness of vitamin D supplementation in~     the prevention of vitamin D deficiency in Polish children (4-10 years of age).~   "
12540|NCT03402685|"~     The caesarean section is a frequently performed procedure in obstetrics and accounts for~     about 30% of all births in Germany. 55% to 68% of all caesarean sections are performed under~     spinal anesthesia. A possible side effect of spinal anesthesia is arterial hypotension with a~     prevalence of 70% to 80%. A placental hypoperfusion in the context of a reduced preload due~     to hypotension can reduce the fetal outcome. Early diagnosis and treatment of the hypotensive~     episode could reduce and at best prevent increased fetal morbidity.~      Due to their invasiveness due to the necessity of puncturing a distal artery of the extremity~     and the insertion of a catheter, established continuous blood pressure measurement procedures~     have disadvantages such as potential circulatory disorders of the hand, infections, bleeding~     and thrombosis and are therefore often not indicated in the context of an elective sectio.~     Non-invasive procedures such as NIBP, however, are discontinuous and may make a timely~     diagnosis of hypotension more difficult and delay therapy. The ClearSightTM system, which~     allows a continuous non-invasive blood pressure measurement, has been used in hip and knee~     joint surgery. There, a good correlation with invasive blood pressure measurements was found,~     particularly with regard to systolic and mean arterial pressure. An application in obstetrics~     has not yet been investigated. Due to the continuous measurement provided by ClearSightTM,~     continuous monitoring of blood pressure appears to be ensured, so that a faster reaction to~     previously undetected fluctuations in blood pressure can be expected compared to interval~     measurement.~   "
12541|NCT03402672|"~     The purpose of this research study is to:~        1. assess how participants like the AWAITS e-health application as measured by their~          feedback on the intervention~        2. test the impact of AWAITS on knowledge about opioid overdose and risk-reduction~          strategies.~        3. assess the proportion of participants who accept a list of local treatment providers~        4. test the impact of AWAITS on interest in being tested for HCV/HIV.~   "
12542|NCT03402659|"~     This is a phase 2b, double-blind, placebo controlled proof-of-concept study of a an oral~     small molecule selective inhibitor of p38 alpha kinase, neflamapimod, administered for 24~     weeks in subjects with mild Alzheimer's disease. The primary objective is to demonstrate~     significant improvement relative to placebo-treatment in episodic memory function, as~     assessed by the Hopkins Verbal Learning Test. Secondary endpoints include Clinical Dementia~     Rating scale (CDR), Wechsler Memory Scale (WMS), Mini-Mental-Status-Examination (MMSE) and~     Cerebrospinal fluid (CSF) biomarkers of AD disease activity and progression.~   "
12543|NCT03402646|"~     This study aims to implement and test the efficacy of photovoice, Short Messaging Service~     (SMS) and phone call reminders in improving childhood immunization coverage (uptake,~     timeliness and completion rates) and reducing incidence of vaccine-preventable diseases~     (VPDs) among infants in Nigeria~   "
12544|NCT03402633|"~     The incidence of leucotrichia has been reported to range from 9 to 48.4% of all vitiligo~     patients.Leucotrichia is more often observed in segmental vitiligo with a very high~     percentage. However, further studies considering the prevalence of leucotrichia in different~     types of vitiligo need to be conducted.~   "
12545|NCT03402620|"~     infertile , poor responders patients who underwent ICSI. The participants were divided into 2~     groups according to the starting dose of Gn stimulation. Group I started with 4 ampoules~     while group II started with 6 ampoules~   "
12546|NCT03402607|"~     This phase II, randomized trial will compare Quality of Life for patients with Hepatocellular~     Carcinoma (HCC) who are not surgical candidates or decline surgery and are treated with~     Percutaneous Local Ablation (PLA) or Hypofractionated Image-Guided Radiation Therapy (HIGRT).~   "
12547|NCT03402594|"~     Hypoxemia is common in acute ischemic stroke and associated with neurological deterioration~     and mortality. However, the benefit of oxygen therapy is controversial. Severity of stroke~     may affect the benefit of oxygen supplementation. Abnormal breathing patterns are commonly~     found among stroke patients and may increase the risk of hypoxemia. High flow nasal cannula~     (HFNC) has several advantages from controllable fraction of inspired oxygen (FiO2), reduction~     of nasopharyngeal resistance and positive end expiratory pressure effect. In this study, we~     aimed to assess the therapeutic effect of HFNC on oxygen desaturation index (ODI) and~     neurological outcomes in stroke patients with moderate and severe severities, compared with~     no and low flow oxygen supplementation.~   "
12548|NCT03402581|"~     Obese patients may have difficulty in airway management.Patients who have body mass index >~     35 are challenging patients for anesthesiologist. Short neck, more adipose tissue may be~     reasons for airway difficulty. Videolaryngoscopes are devices that ease the management of~     difficult airway.This study is designed to evaluate the differences and the effects of~     different laryngoscopes.~   "
12549|NCT03402568|"~     Alcohol consumption is a risk factor for numerous health conditions and an important cause of~     death. Identifying metabolites associated with alcohol consumption may provide insights into~     the metabolic pathways through which alcohol may affect human health. The objective of this~     study is to investigate associations of alcohol consumption with circulating concentrations~     of 123 metabolites including amino acids, acylcarnitines, hexoses, biogenic amines,~     phosphatidylcholines, and sphingomyelins. For this purpose, the investigators use data from~     the European Prospective Investigation into Cancer and Nutrition (EPIC) study and applied a~     discovery and replication approach.~   "
12550|NCT03402555|"~     To observe the stool patterns of healthy infants/toddlers by collecting a panel of stool~     images for the development of a software~   "
12551|NCT03402542|"~     Cold laparoscopic cholecystectomy is the gold standard for the management of symptomatic~     vesicular stones. There is considerable controversy as to whether it should be practiced in~     outpatient surgery or as part of inpatient surgery, regarding to patient safety.~      Minor surgical procedures, such as anal surgery or simple inguinal hernia interventions,~     were initially considered eligible for an outpatient procedure. Advances in surgical~     techniques, anesthesia and early rehabilitation have also made it possible to consider more~     heavy interventions, such as cholecystectomy.~      The aim of this study is to identify eligible patients for laparoscopic cholecystectomy in~     outpatient surgery, taking surgical criteria into account.~   "
12552|NCT03402529|"~     Introduction: To avoid unnecessary mastectomies and reoperations a correct size assessment of~     malignant lesions in breast is required. Sometimes a supplementary MRI is therefore~     recommended. However, at our unit MRI is not easily available. Contrast enhanced spectral~     mammography (CESM) has in smaller studies been shown to be equal to MRI regarding sensitivity~     and specificity. Size assessment using contrast-based modalities as CESM has also been shown~     to be significantly more accurate than using mammography. Prospective randomized studies~     using CESM are lacking.~      Aim: The aim of the study is to evaluate the added value of CESM in diagnostics of breast~     cancer and choice of operation; partial mastectomy or mastectomy.~      A pilot study of 50 patients will be conducted to prepare for a larger prospective randomized~     study.~      Method: Patients found with breast cancer after diagnostics with mammography, ultrasound and~     core biopsy, and whom are recommended primary surgery, will be enrolled in the study. A~     supplementary examination with CESM will be performed. Preoperative extent of the malignant~     lesions are estimated with each modality and is later compared with the extent measured in~     post-operative PAD. Data on weight, length, age at menopaus, use of contraceptive pills, HRT~     or endocrine therapy, breast volume and density is collected, as well as data of diagnosis~     (ductal or lobular carcinoma), surrounding DCIS, histological grade, ER, PgR, Her2 expression~     and Ki67 index.~      In this pilot study sensitivity and specificity for each modality is calculated. Multivariate~     analysis will be performed regarding influential factors. Pearson correlation coefficient~     will be calculated for each modality regarding size assessment of the malignant lesions in~     comparison with definitive PAD.~   "
12553|NCT03402516|"~     Hysteroscopic resection of type 0, 1 or 2 myoma is frequent. The more frequent resector used~     for myoma resection is 26Fr hysteroscope. Actual miniaturization of resector led to 18.5Fr~     resector with a potential benefit because of less dilatation. These resectors are often used~     but no scientific evaluation has been performed.~      Hypothesis of this non inferiority trial is that complete resection in a unique surgical time~     will be comparable with both resectors.~   "
12554|NCT03402503|"~     The aim of this study is to evaluate the safety, feasibility, tolerability and efficacy of a~     new buccal film of montelukast in patients with mild to moderate Alzheimer's disease.~   "
12556|NCT03402477|"~     Among patients treated for locally advanced rectal cancer with neo-adjuvant~     radio-chemotherapy, about 15% will have complete clinical response in terms of no visible~     tumor or ulcerations on the site of the primary tumor, or whitening of the rectal wall or~     telangiectasia. In this Norwegian national multicenter observational study, patients with~     complete clinical response (cCR) after neo-adjuvant treatment for rectal cancer as defined by~     national guidelines, will be invited to a Watch&Wait program with a specially designed~     follow-up in order to see if the tumor has disappeared permanently, or if there is regrowth~     of the tumor. Primary endpoint is the true regrowth rate in an unselected national cohort of~     patients.~   "
12557|NCT03402464|"~     The study was to evaluate the safety, PFS and ORR of icotinib/dihydroaremisinin (DHA)-based~     combination therapy in EGFR-mutated, advanced NSCLC patients who have gradually progressed~     disease after first-line icotinib treatment.~   "
12558|NCT03402451|"~     Korean Stroke Cohort for functioning and rehabilitation (KOSCO) is a large, multi-centre~     prospective cohort study for all acute first-ever stroke patients admitted to participating~     hospitals in nine distinct areas of Korea. This study is designed as a 10-year, longitudinal~     follow-up investigating the residual disabilities, activity limitations, and quality of life~     issues arising in patients suffering from first-ever stroke. The main objectives of this~     study are to identify the factors that influence residual disability and long-term quality of~     life. The secondary objectives of this study are to determine the risk of mortality and~     recurrent vascular events in patients with acute first-ever stroke. Investigators will~     investigate longitudinal health behaviors and patterns of healthcare utilization, including~     stroke rehabilitation care. Investigators will also investigate the long-term health status,~     mood, and quality of life in stroke patient caregivers. In addition, investigators will~     identify baseline and ongoing characteristics that are associated with secondary outcomes.~   "
12559|NCT03402438|"~     The study will investigate the pharmacokinetics of BAY1142524 in subjects with mild to severe~     renal impairment compared to age; weight, and gender-matched healthy subjects.~   "
12560|NCT03402425|"~     To investigate the diagnostic value of 18F-FET PET/MRI instead of MRI alone, children and~     adolescents with tumor in brain or spinal cord are included and scanned primarily at our~     hybrid PET/MRI using the amino acid analog 18F-FET. The scans are performed at primary~     diagnosis, before radiation therapy, before and after operation, when relapse is suspected~     and three or six months after initiation of chemotherapy.~   "
12561|NCT03402412|"~     Phototherapy with narrow band (nb) ultraviolet B (UVB) is a safe and effective but time~     consuming treatment option for patients with widespread eczema. Despite efficacy we know~     little about how it works, and even less why some patients fail to respond. Tintle et al~     showed that nb-UVB induced strong suppression of the Th2 and Th22 axes in patients with~     atopic dermatitis (AD), and also normalized the epidermal barrier function. We want to map~     the very early changes in gene expression after UVB-treatment in order to shed light on~     disease mechanisms, which eventually could lead to better treatment options.~   "
12562|NCT03402399|"~     The aim of the study is to determine the rate of HMR mutations in PMF and secondary MF (post~     PV/ET) subjects, and correlate the rate of mutations with clinical features as known~     prognostic scores.~   "
12563|NCT03402386|"~     To evaluate the efficacy and safety of MT-6548 in peritoneal dialysis subjects with anemia~     associated with chronic kidney disease~   "
12564|NCT03402373|"~     Carotenoids and polyphenols are assumed to have an active role in skin health. Sources for~     these phytonutrient are fruits and vegetables. They are widely applied as skin protectants,~     and supplementation with carotenoids have shown to protect against erythema caused by~     UV-radiation. UV radiation generates reactive oxygen species in the skin, which induces~     cellular signaling that may impair cell cycle, cell growth, and regeneration or repair~     processes.~   "
12565|NCT03402360|"~     The aim of the study is to investigate the effectiveness of motor and cognitive virtual~     environment rehabilitation on upper limb function in sub-acute patients after an acquired~     brain injury.~   "
12566|NCT03402347|"~     This clinical study has been initiated to assess the effect of laser exposure on human skin~     and determine the threshold for tissue damage. The tissue specific effects will be evaluated~     through histological evaluation. Excess skin from corrective surgery (gastric bypass or~     similar) will be donated for this study. Skin samples will be subjected to titrating laser~     treatment with varying laser intensity and exposure time.~   "
12567|NCT03402334|"~     The study aims to compare the effect of a cardiovascular education package intervention on~     treatment-seeking behavioral outcomes of HCV+ patients. This prospective multicenter trial~     will compare outcomes between the intervention group (HCV+ patients receiving the enhanced~     education package) and the control group (HCV+ patients receiving the standard of care, the~     basic education package). The primary outcome measured will be successful linkage to~     hepatology for a discussion of HCV treatment options. The secondary outcome measured will be~     linkage to primary care for chronic disease management.~   "
12568|NCT03402321|"~     clinical comparison between alvogyl and gelatin sponge when used to protect the denuded area~     of the palatal donor site after free gingival graft in means of reducing pain and healing.~   "
12569|NCT03402308|"~     The investigators conduct a randomized, double-blind, placebo-controlled study to investigate~     the effects of the SCE on muscle strength, muscle mass, and muscle function in healthy adults~     for 12 weeks.~   "
12570|NCT03402295|"~     This study compared two main different induction protocols used to treat myeloma eligible~     patients in Brazil. VCD against CTD.~   "
12581|NCT03402152|"~     Subnormal level of Glutamate+Glutamine (Glx) in the Anterior Cingulate Cortex (ACC) of the~     brain has been associated with depression and PTSD. Similarly, interventions that increase~     the level of Glx in the brain, specifically electroconvulsive therapy (ECT) and intravenous~     ketamine infusion have been associated with a rapid decrease in depression and suicidal~     ideation. This effect has been demonstrated in a dose-dependent manner in randomized clinical~     assessments. D-cycloserine, a glycine site modulator of NMDA receptor function has been~     demonstrated to increase Glx in the ACC of normal volunteers. The purpose of this study is to~     determine whether NRX-101, an experimental drug containing a fixed dose combination of~     D-cycloserine and lurasidone (1) raises Glx by a greater amount than either placebo or~     lurasidone alone in patients with bipolar depression, and (2) whether that elevation in Glx~     is correlated with a decrease in depression.~   "
12571|NCT03402282|"~     Hemorrhoidal disease diagnosis is based on medical history combined with physical exam and~     complementary exam. Physical exam should include inspection at exertion, digital rectal exam~     ,and anoscopy.~      The treatment indicated in patients with hemorrhoidal disease varies according to the disease~     grade, and it may be clinical or surgical. The classic surgical approach is an open surgical~     correction , a technique that has high success rates and low recurrence rates; however, it is~     accompanied by intense pain.~      Based on the concept that hemorrhoids are formed by pathological changes in submucosal pads~     vascularization in anal channel transition zone, selective embolization of upper rectal~     artery branches were performed in 14 patients with long-term severe rectal bleeding secondary~     to hemorrhoidal disease by Vidal et al. with no pain or ischemic symptoms being seen.~        -  Main Objective To determine the feasibility of implementing upper rectal artery~          embolization in the treatment of patients with grade 2 (protrude beyond the anal verge~          with straining or defecating but reduce spontaneously) and 3 hemorrhoids (protrude~          spontaneously or with straining and require manual reduction), relating its short- and~          long-term outcomes with patients undergoing surgical repair through the classic~          technique~        -  Hypothesis The expectation is that, with upper rectal artery embolization, patients~          experience a decrease or remission of symptoms, such as bleeding, pain and symptoms~          related to hemorrhoidal pads edema. Another expectation is that the decrease in the~          number of days to return to daily activities~   "
12572|NCT03402269|"~     Clavicle fractures in children are common. Typical treatment includes nonoperative treatment~     with a sling. Operative treatment is usually limited to open, unstable, fractures with either~     epidermal risks or neurovascular compromise. Orthopaedic literature has many studies that~     report the need for additional research for this prevalent fracture. This is an observational~     study evaluating the functional and patient reported outcomes of displaced clavicle fractures~     in adolescents. The results from this study will help the orthopedist understand the expected~     outcomes for a given pediatric patient with a clavicle fracture.~   "
12573|NCT03402256|"~     This is a research study of a text-messaging intervention to reduce alcohol relapse risk in~     pre-transplant liver transplantation patients. This study is an 8-week, randomized controlled~     pilot trial to investigate the feasibility and acceptability of a text-messaging intervention~     for alcohol relapse prevention and stress reduction in 20 liver transplant patients with~     alcohol-related liver disease. The goals of the study are (1) to develop a mobile, SMS-based~     stress reduction and alcohol use intervention for pre- liver transplant patients with~     alcohol-related liver disease (ALD) and (2) to evaluate the feasibility and acceptability of~     the mobile intervention and its effect on rates of alcohol consumption compared to a Standard~     Care condition in a liver transplantation center.~   "
12574|NCT03402243|"~     In this pilot study, menthol cigarette smokers will be randomized to one of three~     experimental marketplaces: 1) a condition simulating a ban on menthol cigarettes but not~     menthol e-cigarettes (condition A); 2) a condition simulating a ban on both menthol~     cigarettes and menthol e-cigarettes (Condition B); and 3) a condition in which menthol is not~     banned for either product (Condition C - the control condition). All conditions would have~     medicinal nicotine available if subjects decide to quit tobacco products entirely. At visits~     occurring every two weeks over a 6 week period, subjects will receive credits that they~     could exchange for any product available in their randomized marketplace condition. Outcomes~     include the amount of each tobacco product used.~   "
12575|NCT03402230|"~     This randomized early phase I trial studies how well broccoli sprout/broccoli seed extract~     supplement works in decreasing toxicity in heavy smokers. Broccoli sprout/broccoli seed~     extract supplement is a dietary supplement made from broccoli sprout and seed extract powder,~     and may break down some of the cancer causing substances in tobacco smoke and produce~     substances that may protect cells from tobacco smoke-induced damage in current smokers.~   "
12576|NCT03402217|"~     This study will evaluate a smart phone-based application (app) designed to inform pregnant~     women ages 15-25 about their contraception options. The goal of this research will be to~     evaluate the usability, feasibility and acceptability of this app.~   "
12577|NCT03402204|"~     Patients with acute ischemic stroke will be divided into 2 groups by double-blind,~     randomized, and controlled trial. Personality and past history of the patients will be~     recorded after the patients signed inform consent. The patient will be collected blood among~     10 cc. for measurement biomarker in serum that related plaque stability for baseline and~     obtained neurological examination for baseline.~      The patients must be take pills for 180 days by randomized code number on pill box, and~     patients must be turn into the site for follow up visit at Day 90 and Day 180. All visits of~     the patients will be collected blood among 10 cc. for measurement biomarker in serum that~     related plaque stability and obtained neurological examination.~      Next, the data will be separated with code number for divided group into 2 groups. Group 1 is~     simvastatin 10 mg per day treatment (n=36) and Group 2 is simvastatin 40 mg per day~     treatment. Finally, all data of each group will be calculated mean ± standard deviation, and~     compared by statistical analysis.~   "
12578|NCT03402191|"~     This study compares L-arginine Versus Sildenafil as treatment for pulmonary hypertension in~     Children with Beta Thalassemia~   "
12579|NCT03402178|"~     This study will be conducted to evaluate the safety, tolerability, and pharmacokinetics (PK)~     of single ascending oral doses of E2082 in healthy Japanese adult and elderly male~     participants, and to evaluate the safety, tolerability, and PK of multiple ascending oral~     doses of E2082 in healthy Japanese and Caucasian adult male participants.~   "
12580|NCT03402165|"~     Alpha-fetoprotein Levels on the Response to direct Antiviral Therapy in Patients with Chronic~     Hepatitis C~   "
12582|NCT03402139|"~     The molecular mechanisms underlying developmental programming of childhood obesity remain~     poorly understood. Here, the investigators address major questions about early childhood~     obesity programming by studying CD3+ T-cells from intrauterine growth restricted (IUGR)~     newborns who have an increased risk for obesity and other metabolic disorders in adult life.~   "
12583|NCT03402126|"~     The purpose of the Medtronic Tachy Prediction Download (TPD) study is to collect data from an~     implantable cardiac defibrillator (ICD) device that will be used to identify markers for~     imminent onset of ventricular arrhythmias.~   "
14643|NCT03375268|"~     The purpose of this study was to identify the major complications and their risk factors of~     elderly patients who had undergone Hemi-hip Arthroplasty.~   "
12584|NCT03402113|"~     To investigate the effects of different sedation protocols on skeletal muscle metabolism in~     mechanical ventilated patients in ICU. Mechanical ventilated patients who are anticipated to~     stay in ICU for more than 5 days are enrolled and randomly assigned to the following three~     groups, interventional group(dexmedetomidine), control group(midazolam) and no sedation~     group. Serum, CT scan of intercostal muscles, ultrasound evaluation of quadriceps femoris are~     obtained.~   "
12585|NCT03402100|"~     The myopia prevalence in schoolchildren is high in Taiwan. The myopia progression is fast in~     children and often associated high myopia in later life. This prospective and randomized~     study to investigate the effect of myopia control in myopic children with ultra low~     concentrations of atropine eye drops and/or low concentrations of anti-allergic and~     inflammatory eye drops.~   "
12586|NCT03402087|"~     The purpose of this study is to investigate effects of BMS-986165 on blood levels of~     methotrexate given as a single dose in healthy male patients.~   "
12587|NCT03402074|"~     This prospective feasibility study aims to test a 5 week group hypnosis training as~     intervention to reduce perceived psychological stress in healthy subjects.~   "
12588|NCT03402061|"~     Nutrition in Disguise is focused on developing and testing the acceptability of nutrient~     dense food products appropriate for older adults and specifically those living in long term~     care.~   "
12589|NCT03402048|"~     This is a randomized phase III trial that will randomize elderly patients(70 years of age and~     older) who are not considered eligible for standard doublet or triplet regimens. In a 2:1~     fashion, patients will be randomized to the customization arm or the standard arm,~     respectively. This trial will be offered to patients who are previously untreated for stage~     IV NSCLC.~      The primary objective is to evaluate if chemotherapy selection based on histology and tumoral~     molecular determinants ERCC1, RRM1 and TS (arm A, the experimental arm) results in superior~     outcome in elderly patients with untreated, advanced NSCLC compared to standard of care~     treatments (arm B, the standard arm).~   "
12590|NCT03402035|"~     The LITES Network is an operational trauma center consortium which has the expertise, track~     record and confirmed capabilities to conduct prospective, multicenter, injury care and~     outcomes research of relevance to the Department of Defense (DoD).~      Hemorrhage and Traumatic Brain Injury (TBI) are responsible for the largest proportion of all~     trauma-related deaths. It is the poly-trauma patient who suffers both hemorrhagic shock and~     traumatic brain injury where a paucity of evidence exists to direct treatment, limiting the~     development of beneficial trauma practice guidelines.~      The use of Whole Blood (WB) for early trauma resuscitation has been touted as the 'essential~     next step' in the evolution of trauma resuscitation. Despite its historical and more recent~     use, little is known regarding WB's benefit relative to the 'current practice' ratio-based~     blood component therapy in the acutely bleeding patient, and even less is known regarding its~     effects in patients with TBI.~      AIM#1: Evaluate patient centered outcomes associated with early whole blood resuscitation~     practice as compared to component resuscitation in poly-trauma patients with hemorrhagic~     shock and further characterize outcome benefits in those with traumatic brain injury.~      AIM#2: Characterize blood pressure and resuscitation endpoints during the acute resuscitation~     phase of care and the associated/attributable outcomes for traumatic brain injury in patients~     with hemorrhagic shock.~      General Hypothesis #1: Whole blood resuscitation will be associated with improved mortality~     and resuscitation outcomes in poly-trauma patients and long term neurological outcome in~     those patients with traumatic brain injury as compared to those resuscitated with component~     therapy.~      General Hypothesis #2: Differences in prehospital and acute phase resuscitation systolic~     blood pressure will be associated with differential outcomes in patients with traumatic brain~     injury at discharge and at 6 months.~      Study Design: The LITES network will perform a multicenter, prospective, observational cohort~     study over a 4 year period to determine the impact of whole blood resuscitation in trauma~     patients with hemorrhagic shock at risk of large volume resuscitation with and without TBI.~     Early whole blood resuscitation will be compared to standard component resuscitation. The~     study will also further characterize blood pressure and resuscitation endpoints in~     poly-trauma patients with traumatic brain injury. Six Trauma sites with appropriate~     characteristics will be selected from 12 LITES Network sites across the country.~      Study Setting: The study will be performed utilizing busy level I trauma centers within the~     LITES Network located across the country, at sites where either whole blood has currently~     been incorporated into standard of care or where component blood transfusion is being~     utilized for patients in hemorrhagic shock at risk for large volume resuscitation.~      Study Population: The study will focus on patients who suffer blunt or penetrating injury,~     transported to a SWAT participating LITES trauma center with evidence of hemorrhagic shock at~     risk of large volume blood resuscitation.~   "
12591|NCT03402022|"~     Hypothesis: To verify whether the use of drugs, in particular performance-enhancing drugs, is~     prevalent amongst participants in a very long distance mountain trail.~      Primary objective : To qualify and quantify drug use amongst participants in a very long~     distance mountain trail, by targeting the molecules most likely used by the runners.~   "
12592|NCT03402009|"~     The purpose of this study is to determine what tools best assist university students develop~     a personal meditation practice to self-manage stress. The two treatment conditions are 1)~     independent meditation using web-based tools and apps, and 2) independent meditation using~     web-based tools, apps and EEG-based neurofeedback. Outcomes of interest include~     acceptability, adherence, changes in mental health (i.e., anxiety, stress), physical health~     (i.e., sleep, inflammation), resilience, and level of commitment to further practice. Factors~     related to self-regulation (i.e., interoceptive awareness, self-esteem) will also be assessed~     as potential outcome moderators.~   "
12593|NCT03401996|"~     Double-blind randomized, sham-controlled clinical trial of 1 mA bilateral supplementary motor~     area in adolescents/adults with Tourette syndrome (TS). The primary objectives are to assess~     and quantify the safety and efficacy on tic severity of 5 inhibitory sessions of active vs.~     sham tDCS sessions during active tic suppression, and to explore the differences in brain~     functional activity before and after 5 sessions of active or sham cathodal tDCS in~     adolescents and adults with TS. Secondary objectives include the assessment of the severity~     of comorbidities after 5 inhibitory tDCS sessions.~   "
12594|NCT03401983|"~     The aim of this study was to investigate the effectiveness of pelvic floor muscle and~     abdominal training in reproductive-age patients with stress urinary incontinence.~      This prospective randomized controlled design study included 64 female patients aged 18-49~     years with stress urinary incontinence. The patients were divided into 2 groups (32 PFMT~     Pelvic Floor Muscle Training and 32 PFMT+AT Abdominal Training) by computer-based~     randomization. The stress urinary incontinence type was assessed by a stress test, and the~     pelvic floor muscle strength was measured with a home biofeedback device. Voiding functions~     were assessed by a 3-day voiding diary and uroflowmetric test. The UDI-6 scale was used to~     assess the urinary symptoms, and the IIQ-7 scale was used to assess the quality of life. The~     follow-up measurements of both groups were obtained in the 0th, 4th, and 8th weeks.~   "
12595|NCT03401970|"~     This is a 2-year randomized controlled trial to test the effect of dietary carbohydrates,~     both quality and quantity, on changes in internal body fat mass. Up to 250 women and men with~     obesity are recruited in Bergen, Norway, and randomized to one of the following normo- and~     isocaloric dietary patterns (same amount of protein, polyunsaturated fatty acids and moderate~     energy, 2,000 - 2,500 kcal per day): 1) a low-fat high-carbohydrate diet primarily with~     refined (e.g., flour-based) carbohydrate sources, 2) a low-fat high-carbohydrate diet based~     on minimally refined (e.g., cellular) carbohydrate sources, and 3) a very-high-fat~     low-carbohydrate diet.~   "
12596|NCT03401957|"~     To evaluate the emergence of RAS mutation in patients with metastatic colorectal cancer,~     circulating free DNA will be analyzed using mass spectrometric genotyping in subjects during~     cetuximab treatment. The hypothesis of this study is that acquired RAS mutation is~     responsible for the resistance to cetuximab treatment in wild-type colorectal cancer. The~     usefulness of liquid biopsy to monitor dynamic genetic alterations in colorectal cancer~     during treatment will also be investigated in this study.~   "
12597|NCT03401944|"~     The study investigates effects related to muscle protein metabolism at provision of Total~     Parenteral nutrition.~   "
12598|NCT03401931|"~     pilot clinical study, multicenter, prospective, open, nonrandomized~   "
12599|NCT03401918|"~     The purpose of this study is to determine if patients with recurrent pregnancy loss or~     unexplained infertility have an altered uterine gene expression or uterine microbiome~     (micro-organism composition) during the window of embryo implantation. Furthermore we would~     like to assess for women with an abnormal uterine gene expression whether vaginal~     progesterone medication improves or alters gene expression and for women with an abnormal~     microbiome whether antibiotic treatment followed by probiotic treatment normalizes the~     microbiome.~   "
12600|NCT03401905|"~     Comparison between high and low frequency percutaneous electrical nerve stimulation as~     treatment of myofascial chronic neck pain. The main hypothesis is that low frequency~     treatment will have more hypoalgesic effects than high frequency, and low frequency effects~     will last longer.~   "
12601|NCT03401892|"~     Ischemic optic neuropathy is among the most common causes of serious impaired vision in the~     middle-aged and elderly population in the western world. The current study focuses on a~     subgroup of ischemic optic neuropathy, the so-called non-arteritic ischemic optic neuropathy~     (NAION). Although the exact pathogenesis of NAION has not been fully clarified it is known~     that patients with cardio-vascular risk factors such as hypertension, diabetes mellitus and~     dyslipidemia have also an increased risk to develop NAION. Along this line of thought it has~     been shown that patients with a history of NAION in one eye have an increased risk to develop~     NAION also on the contralateral eye. However, clinical studies investigating ocular perfusion~     abnormalities in patients with NAION are sparse and even contradicting. Thus, the current~     study seeks to measure ocular blood flow parameters in patients with a history of NAION and~     compare it to healthy age-matched subjects.~   "
12602|NCT03401879|"~     Multiple sclerosis (MS) affects approximately 2.3 million patients worldwide, with a global~     median prevalence of 33 per 100,000. MS is diagnosed at an average of 30 years and affects~     twice as many women as men. MS is traditionally diagnosed by the presentation of lesions of~     the central nervous system, disseminated in time and in space, proven by clinical examination~     and magnetic resonance imaging. Several anatomical parameters in the eye, both vascular and~     neural, have been found to be altered in MS patients.~      Because of its unique optical properties, the eye offers the possibility of the non-invasive~     assessment of both structural and functional alterations in neuronal tissue. As the~     neuro-retina is part of the brain, it does not come as a surprise that neuro-degenerative~     changes in the brain are accompanied by structural and possibly also functional changes in~     the neuro-retina and the ocular vasculature.~      The current study seeks to test the hypothesis that beside the known anatomical changes, also~     functional changes can be detected in the retina of patients with MS. For this purpose,~     flicker light induced hyperemia will be measured in the retina as a functional test to assess~     the coupling between neural activity and blood flow. Further, structural parameters such as~     retinal nerve fiber layer thickness and function parameters such as ocular blood flow and~     retinal oxygenation will be assessed and compared to age and sex matched controls.~   "
12603|NCT03401866|"~     This clinical trial is to validate and demonstrate the clinical usefulness of a protocol for~     Magnetic Resonance Imaging (MRI) in people with high grade glioma brain tumors.~   "
12604|NCT03401853|"~     This phase II trial studies how well rituximab and pembrolizumab work in treating patients~     with follicular lymphoma or diffuse large B cell lymphoma that has come back or does not~     respond to treatment. Monoclonal antibodies, such as pembrolizumab and rituximab, may~     interfere with the ability of cancer cells to grow and spread.~   "
12605|NCT03401840|"~     The main objective of this national, open-label, non-randomized phase II trial is to evaluate~     severe late toxicity of postoperative hypofractionated stereotactic radiotherapy (SBRT) in~     the treatment of early stage oropharyngeal and oral cavity cancer with high risk margins.~   "
12606|NCT03401827|"~     Pancreatic cancer is a very poor prognosis and has a high mortality rate. The clinical~     results have improved somewhat with the combination therapy of chemotherapy as the first-line~     treatment. However, effective secondary chemotherapy after these first-line treatment~     failures is limited. Recently, FOLFIRINOX has been used in patients with locally advanced or~     metastatic pancreatic cancer who have good performance in Korea. Gemcitabine + nab-paclitaxel~     (GnP) as a second-line treatment after FOLFIRINOX may be expected to be considerable. The aim~     of this study was to evaluate the efficacy of GnP as a second-line treatment after failed~     FOLFIRINOX treatment for locally advanced or metastatic pancreatic ductal adenocarcinoma.~   "
12607|NCT03401814|"~     Patients will be imaged with MRE at the time of the RT planning MRI, prior to the induction~     of RT and immunotherapy. Research imaging will be in addition to standard imaging studies~     performed at time points consistent with the standard of care (at the time of the RT planning~     MRI and the first clinical follow-up). An additional MRE exam will be performed at the end of~     treatment outside the standard of care imaging.~   "
12608|NCT03401801|"~     The purpose of this study was to compare the temperature changes of the upper extremities~     when using local anesthetic of various volume (4ml, 6ml, 8ml) in the ultrasound guided~     stellate ganglion block.~   "
12609|NCT03401788|"~     This study is designed to investigate PT2977 as a treatment for VHL disease associated RCC.~   "
12610|NCT03401775|"~     The purpose of this study is to investigate the effect of cognitive rehabilitation program on~     the improvement of cognitive functions in normal elderly subjects.~   "
13170|NCT03394456|"~     This study evaluates the effect of diabetes group visits that are led by Community Health~     Workers (CHWs). Half of the subjects will be randomized to receive a 6-month, CHW-led group~     visit program (intervention) and the other half will be randomized to receive 6-months of~     treatment as usual in the clinic followed by the group visit program (wait list control). The~     CHWs will receive training and support via telemedicine.~   "
12611|NCT03401762|"~     The purpose of the study is to explore the feasibility of using a wearable device, called a~     myoelectric-computer interface (MCI), to improve arm movement in people who have had a~     stroke.~      Impaired arm movement after stroke is caused not just by weakness, but also by impaired~     coordination between joints due to abnormal co-activation of muscles. These abnormal~     co-activation patterns are thought to be due to abnormal movement planning.The MCI aims to~     reduce abnormal co-activation by providing feedback about individual muscle activations.~      This randomized, controlled, blinded study will test the home use of an MCI in chronic and~     acute stroke survivors.~   "
12612|NCT03401749|"~     Intervention: This study will involve three different study arms with different interventions~     prior to surgery: (1) shower only, (2) shower plus Theraworx wipes, (3) shower plus~     chlorhexidine wipes~      Study Design: Single center RCT~      Sample Size: 500 patients, aged 18+~      Objectives: Primary Objectives:~        1. Monitor for safety and adverse effects.~        2. Evaluate for differences in peri-operative skin cultures between treatment groups;~        3. Compare surgical site infection rates between groups.~      Secondary Objectives:~        1. Assess for patient compliance for each different treatment arms.~        2. Measure patient satisfaction.~        3. Measure nurse satisfaction.~        4. Visual assessment of wound healing~      Expected Results: We expect no statistically significant difference in peri-operative~     cultures or surgical site infection rates between groups.~   "
12613|NCT03401736|"~     Bidirectional communication between the CNS and the GI tract - the brain-gut axis - occurs~     both in health and disease.Patients with mechanical ventilation in ICU (ICU) often meet the~     necessary nutritional needs. These patients often appear varying degrees of intestinal flora~     imbalance, such as diarrhea, vomiting, abdominal distension and other complications, which~     exert negative effect on treatment and prolong hospitalization time.So far，whether the~     sedative drugs used for a long time in mechanically ventilated patients will affect the~     diversity of intestinal flora or not has not been reported.The effects of different sedative~     drugs on the intestinal flora diversity need further study.Therefore, this topic will used~     midazolam and dexmedetomidine to study the effect on the diversity of intestinal~     microbiota.Meanwhile，the research will provide a theoretical basis for rational use of~     mechanical ventilation and sedative drugs.~   "
12614|NCT03401723|"~     A cross validation study comparing an international acknowledged assessment tool Endoscopy~     Training System (ETS) and movement analysis of the colonoscope based on raw data from coils~     within the scope.~      24 physicians are recruited and divided based on experience (novices and experienced). All~     participants are to perform twice on the ETS that is based on four tasks; Scope manipulation,~     tool targeting, loop management and mucosal inspection. The movement of the colonoscope will~     be gathered during the tasks and correlated to the scores of the ETS.~   "
12615|NCT03401710|"~     The use of erythropoietin to treat anemia in acute kidney injury (AKI) is controversial. No~     previous clinical trial has assessed the possible reduction of transfusions when~     erythropoietin is started very early in a setting of in-hospital acute kidney injury.~      This randomised multicenter pragmatic clinical trial will compare the need for transfusion in~     acute kidney injury between two groups: group 1 will receive erythopoietin 4000 UI every~     other day and group 2 the usual treatment.~   "
12616|NCT03401697|"~     Initially, HCV Informatics (C-IT) will be used to filter the EMR data of the one million~     people who receive care at Mount Sinai and identify candidates for HCV testing (baby boomers,~     patients with HIV infection) and candidates for HCV treatment (patients with positive test~     results for HCV RNA and no record of treatment).once treatment candidates have been~     identified through this proactive approach, their providers will be directly notified. HCV~     champions and patient navigators will be used to further lower barriers to the delivery of~     HCV care. They will be co-located at non-hepatology care sites and will help deliver~     open-label HCV treatment as part of standard medical care to 500 HIV/HCV co-infected patients~     and 200 patients with type 2 diabetes.~   "
12617|NCT03401684|"~     The purpose of the study is to assess the impact of a mental health training program in~     volunteer and career firefighters.~   "
12618|NCT03401671|"~     The purpose of this study is to evaluate the pharmacokinetics (PK), safety and tolerability~     and pharmacodynamics (PD) of lanadelumab in healthy adult Japanese subjects and matched~     non-Hispanic healthy adult Caucasian subjects.~   "
12619|NCT03401658|"~     Infections that are caused by surgical incision are commonly known as surgical site~     infections (SSI). A surgical wound infection can develop at any time after surgery until the~     wound has healed (usually two to three weeks after the operation). Very occasionally, an~     infection can occur several months after an operation. About 5 in 100 patients develop SSI~     after hospital discharge. During the patient's stay in hospital, nurses routinely change~     their wound dressings to check for any signs of infection. However, since infections develop~     after patients leave hospital it is difficult for staff to monitor signs in patients' homes.~     In some hospitals, staff may contact patients in their homes to check on their wounds but~     most of the time it is not possible. The recent improvement in surgical operations means that~     more patients are discharged from hospital earlier than they would have been in the past even~     before their wounds are healed. Increasingly, patients develop SSI after leaving hospital~     particularly among the more vulnerable high risk groups. Signs of SSI may not always be~     recognised by the patient and delays in seeking care leads to serious infection-related~     complications. The investigators wish to fit a device onto the patients' personal mobile~     phone camera lens. This will allow patients to take pictures of their wound routinely at home~     submit images automatically to a computer at the hospital for analysis. Staff at the hospital~     will alert the patient if the results strongly that indicate signs of infection and an~     appropriate treatment plan put into place for you. This type of technology has never been~     used in this application before so, the investigators plan in this study to find out whether~     it can accurately detect early signs of wound infections and whether it is easy to use,~     acceptable to the patient and their health care professionals. A total of 40 patients will be~     invited to take part in the study over a period of 12 months.~   "
12620|NCT03401645|"~     The purpose of this study is to find out whether the Home-based Arm and Hand Exercise (HAHE)~     program improves functions of the upper limb that is affected after traumatic brain injury.~     HAHE is made up of exercises that simulate real-life tasks.~   "
12621|NCT03401632|"~     Enteral nutrition in critically ill patients undergoing vasoactive support due to hemodynamic~     instability is controversial. Hypothesis: enteral nutrition delivered in such patients can be~     feasible and safe.~   "
12634|NCT03401463|"~     There is no accepted standard for the frequency of monitoring endotracheal tube cuff~     pressures (ETCP). the investigators plan on comparing two strategies for monitoring ETCP in~     mechanically ventilated patients.~      Nowadays ETCP is evaluated once every 24 hours. Next, the investigator want to conduct~     training for medical and nursing staff. After the training, ETCP will be measured every 8~     hours.~      The aim of the study is to prove that more frequent pressure control (3 times a day) reduces~     the occurrence of abnormal ETCP.~   "
12622|NCT03401619|"~     Epigenetic modification refers to the change of heritable gene expression occurring in the~     case of unchanged DNA sequence, including DNA methylation, epigenetic modification, RNAS,~     chromatin modification, etc. The study found that osteoporosis (OSTEOPOROSIS,OP) with~     neurological disorders is very common, the risk of fracture of patients increased. It is~     considered that epigenetic regulation plays an important role in the occurrence and~     development of OP with neurological disorders. In particular, the role and molecular~     mechanism of epigenetic modification in OP with neurological disorders are not clear, and the~     results of clinical studies with different sample sizes are not consistent. (1) Two-way~     continuous queues,an ambispective cohort study， namely: forward-looking queue method~     (2017-2027) and Retrospective queue method (2007-2017) were used to understand the effect of~     epigenetic modification on bone mineral density, bone metabolic Biochemical Index, imaging~     index and fracture incidence of patients with neurological diseases in outpatients and wards,~     and to provide basis for further study. To observe the effects of epigenetic modification on~     cognitive function in two groups of patients (memory scale, life activity Energy meter (ADL)~     and cognitive scale (MMSE) and clinical physical examination and neuropsychological test,~     etc., Bone correlation detection (Lumbar and hip bone mineral density T-score, imaging index,~     bone Metabolic Biochemical Index and fracture incidence index) Influence. Multivariate~     stepwise regression analysis was performed to eliminate confounding factors, such as age,~     body mass index (BMI), related risk factors, and internal diseases. The patient's previous~     information is also analyzed; (2) To find meaningful epigenetic modification from clinical~     data, the molecular mechanism was studied in depth, and the imaging indexes (X-ray, CT, MRI)~     and Bone marker Index (serum osteocalcin (OC), total I-type procollagen peptide (TP1NP) were~     found in the study. Type I collagen hydroxy-terminated peptide beta degradation product~     (Β-CTX)). The relationship between the reaction epigenetic modification and cognitive~     function index, image and bone markers and the mechanism model were further established.~   "
12623|NCT03401606|"~     This study evaluates the surgeon and patient´s satisfaction who undergoes cataract surgery~     using either dexmedetomidine or remifentanil as sedation~   "
12624|NCT03401593|"~     This study is prospective randomized study which was performed in multicenter (General~     Hospital) in Korea. Inclusion criteria is patients who developed atrial~     fibrillation/flutter/tachycardia after pacemaker implantation among AF-pacemaker study~     (ClinicalTrials.gov Identifier: NCT03303872). The purpose is to investigate the recurrence~     rate of AF/AFL/AT in both groups after randomization for 60 months (5 years) in patients post~     pacemaker implantation and assess long term clinical results.~   "
12625|NCT03401580|"~     The purpose of this study is to evaluate the efficacy of different fixed-dose combination of~     Viena II in treatment of hypertension and dyslipidemia.~   "
12626|NCT03401567|"~     Purpose of the study is; to investigate the effect of exercises combined with blood flow~     restriction on strength, proprioception and functional motor performance in healthy~     individuals. There is no randomized controlled study of the effect of upper extremity~     exercises performed by restricting blood flow on the joint sensation of individuals and~     functional motor performance in healthy individuals. For this reason, purpose of the study~     is; to investigate the effect of exercises combined with blood flow restriction on strength,~     proprioception and functional motor performance in healthy individuals. Pain intensity with~     the numerical pain rating scale (NRS), muscle strength with digital hand dynamometer,~     shoulder and elbow proprioception with inclinometer, functional motor performance with Upper~     Extremity Closed Kinetic Chain Stabilization Test, Functional Throwing Performance Index,~     Single Arm Shot Put Test, Modified Pull-Up Test evaluation of 60 healthy individuals without~     neck and upper extremity pain, the fracture and surgical history for the upper extremity,~     cervical and thoracic area that prevent them to participate in the study will be made.~     Participants will randomly be separated into 2 groups of 30 people each. Elbow bending~     exercises with blood flow restriction will be performed to the exercise group during 6 weeks~     for 3 times a week accompanied by a physiotherapist. Control group will continue daily~     activities and a brochure on strengthening exercises and protection from injuries.~     Evaluations will be repeated 2 times and analyzed before the treatment and at the end of the~     6th week. With the project, the investigators aim to improve the strength, improve~     proprioception and functional motor performance in healthy individuals by performing~     exercises restricting blood flow. With the achievement of the targets, exercises combined~     with blood flow restriction can be considered among the treatments protective for injuries,~     healing proprioception. The investigators also believe that the project will blaze the trail~     for the studies to be performed on athletes.~   "
12627|NCT03401554|"~     Evaluation the amount of bone height gained when using titanium mesh in closing the lateral~     window of the sinus compared to collagen membrane.Evaluation the quality of new bone gained~     when using of the titanium mesh to close the lateral window of the maxillary sinus as a new~     option for tenting compared to collagen membrane.~   "
12628|NCT03401541|"~     To evaluate the pharmacokinetic parameters of orally administered 25-hydroxyvitamin D3~     [25(OH)D3] and vitamin D3 from the corresponding serum concentration-time curves in healthy~     adults and adults with a history of intestinal malabsorption.~   "
12629|NCT03401528|"~     This is a randomized single-blind, placebo-controlled, Phase 1, single ascending dose (SAD)~     and repeat dose (RD), safety and tolerability study of AVB-S6-500 in healthy subjects. A SAD~     portion of the study consists of 4 sequential dose escalation cohorts, whereas RD portion of~     the study consists of a single cohort receiving 4 weekly doses of AVB-S6-500. In both SAD and~     RD study arms, subjects are randomized to receive either a study intervention (AVB-S6-500) or~     matching placebo.~   "
12630|NCT03401515|"~     Traumatic Brain Injury (TBI) is one of the leading causes of death. Severe TBT is correlated~     with an exaggerated stress response due to plasma catecholamine levels known as sympathetic~     storming. It is also autonomic dysfunction syndrome. This phenomenon is also associated with~     brain tumors, severe hydrocephalus and subarachnoid hemorrhage. Patients are presented by~     tachycardia, tachypnea hypertension, diaphoresis, dystonia, hyperthermia, and dilated pupils~     with elevated levels of plasma catecholamine and blood glucose .~   "
12631|NCT03401502|"~     This is a double-blind, randomized, placebo-controlled, and parallel study. The study is~     comprised of three main phases: a single-blind placebo run-in qualifying phase lasting about~     14 days, a double-blind treatment phase of 12 weeks, and a 2-week follow-up phase.~     Approximately 18 patients will be enrolled and randomly assigned to receive placebo or 1,000~     mg of extended-release Ranolazine twice-daily for 12 weeks to reach 14 evaluable patients at~     the end of the study.~   "
12632|NCT03401489|"~     Program to Avoid Cerebrovascular Events through Systematic Electronic Tracking and Tailoring~     of an Eminent Risk-factor (PACESETTER) aims to assess the incorporation of its stroke~     intervention into all 3 safety net/academic health sytems in a given US state especially~     burdened by stroke, thereby enhancing knowledge about the complexity of stroke interventions,~     and especially the nature of the challenges encountered in low resource settings and for~     populations traditionally underrepresented in research. Altogether, the intervention, if~     proven implementable and effective, may eventually be exported to other medically underserved~     populations in the US beyond SC as a feasible model of post-stroke management.~   "
12633|NCT03401476|"~     Despite advances in treatment and corresponding improvements in survival, patients with~     pulmonary arterial hypertension (PAH) remain highly symptomatic. In one survey of 315~     patients with PAH, sixty-eight percent had moderate or severe dyspnea on exertion and 40% had~     a profound and clinically significant deficit in quality of life. Palliative care is being~     increasingly investigated in life-limiting cardiovascular diseases to alleviate symptoms. In~     PAH, its implementation is frequently delayed until end-of-life. Opioids are a common~     palliative care intervention, however the efficacy and safety of opioids for symptom relief~     in PAH has not been evaluated.~   "
13171|NCT03394443|"~     This study aims to understand parents' needs regarding social difficulties faced in a child's~     preterm birth context.~   "
12635|NCT03401450|"~     This is a prospective, randomized, single blinded trial involving human subjects. The goal of~     this study is to determine an optimal location (proximal or distal) for the nerve block and~     whether it will make a difference in how much opioid the patient will receive during and~     after surgery. Ultrasound will identify the adductor canal and the proximal end of the~     adductor canal/apex of the femoral triangle to determine the location of the blocks.~      Their will be two randomized groups: 1. ACB within true AC with bupivacaine 0.5% 20cc2. ACB~     proximal to true AC with bupivacaine 0.5% 20cc~   "
12636|NCT03401437|"~     To evaluate quality of life before and after laparoscopic removal of the Essure® system.~     Women who complain about symptoms attributed to the Essure® device are expected to have an~     improved quality of life postoperatively.~   "
12637|NCT03401424|"~     To observe and compare the short-term and long-term effects of different biliary and~     intestinal reconstruction methods for the treatment of congenital cystic dilatation of bile~     duct .~   "
12638|NCT03401411|"~     The primary objective of this study is aimed at analyzing the ICU triage practices of~     clinicians at a cancer hospital with and without the use of an algorithm-based triage tool,~     and to assess whether or not the triage tool improves the consensus amongst practioners on~     the prioritization of patients for ICU admission. Secondary objectives include assessment of~     whether or not triage practices based on guidelines correlate with what is done in actual~     practice.~   "
12639|NCT03401398|"~     SHIPSS is a multi-institutional, prospective, controlled, randomized, double-blinded~     interventional trial that will examine the potential benefits and risks of adjunctive~     hydrocortisone prescribed for children with fluid and vasoactive-inotropic refractory septic~     shock.~      It is hypothesized that adjunctive hydrocortisone will significantly reduce the proportion of~     children with poor outcomes, defined as death or severely impaired health-related quality of~     life, as assessed at 28 days following admission to a pediatric intensive care unit for the~     sepsis event.~   "
12640|NCT03401385|"~     This study is one single group of participants with NSCLC who have not been cured by other~     treatments. It is the first time the drug has been used in humans, and will be in two parts.~      The primary purpose of the parts are:~        -  Dose Escalation: To investigate the safety and tolerability and to determine the maximum~          tolerated dose (MTD) and the recommended dose for expansion (RDE) of DS-1062a~        -  Dose Expansion: To investigate the safety and tolerability of DS-1062a~      This study is expected to last approximately 2.5 years from the time the first subject is~     enrolled to the time the last subject is off the study.~      The number of treatment cycles is not fixed in this study. Participants who continue to~     benefit from the study treatment may continue, unless:~        -  they withdraw~        -  their disease gets worse~        -  they experience unacceptable side effects.~   "
12641|NCT03401372|"~     Survival of intermediate and high-risk primary light chain amyloidosis (pAL) remains poor due~     to high mortality within 3-6 months of diagnosis. Rapidly effective regimens such as~     bortezomib, cyclophosphamide and dexamethasone (BCD) still failed to overcome the poor~     prognosis in very advanced pAL amyloidosis patients. Recently, doxycycline was demonstrated~     to induce disruption of fibril formation and reduce the number of intact fibrils in~     transgenic mouse model of pAL amyloidosis. Furthermore, case-control study suggested that~     adjuvant oral doxycycline could improve response and survival in cardiac pAL amyloidosis,~     which necessities further confirmation through a randomized trial. Therefore, we designed a~     multi-center randomized open-label controlled study to investigate the efficacy and safety of~     co-administration of oral doxycycline with BCD regimen in treatment-naïve patients with Mayo~     stage II-III pAL amyloidosis. The primary outcome progression-free survival, and secondary~     endpoints including overall survival, hematologic response, organ response and toxicity of~     doxycycline will be evaluated.~   "
12642|NCT03401359|"~     The investigators propose to conduct a biomarker and molecular profiling study in~     longitudinally paired tumor biopsies and serum from patients with Hormone Receptor positive~     (HR+) metastatic Breast Cancer (BC) treated with Palbociclib in combination with endocrine~     therapies.~   "
12643|NCT03401346|"~     A Phase I clinical trial to compare the bioavailability of dihydroergotamine mesylate (DHE)~     following a single dose administration of INP104 (DHE administered by I123 Precision~     Olfactory Delivery (POD) Device Nasal Spray) to that of D.H.E. 45 for Injection (Intravenous)~     and Migranal Nasal Spray in healthy adult subjects.~      It is hypothesized that INP104 will address the current variability in nasal administration~     and give more reproducible dose delivery compared to Migranal nasal spray.~      Blood concentrations of all three investigational products will be compared for 48 hours~     following dosing. The safety and tolerability of INP104 will be monitored throughout the~     study.~      INP104 has been developed for the treatment of acute migraine headache. The device in which~     the drug will be delivered has been designed to deliver the medication to the upper nasal~     cavity with minimal variation in dose absorption, eg loss via dripping out of the nose or the~     dose being swallowed.~      Approximately 36 participants in general good health (equal ratio of males and females~     desired) will be enrolled and will be allocated to receive 3 treatments in a randomized~     sequence. They will receive a single dose of INP104, a single dose of DHE via intravenous~     injection, and a single dose of Migranal Nasal Spray. There will be a wash out period where~     no treatment will be administered for 7 days in between each treatment. Participants are~     required to attend 3 inpatient periods and 1 final outpatient visit. Each participant will be~     in the study for up to 43 days.~   "
12644|NCT03401333|"~     This study tests the feasibility of an intervention to prevent risky alcohol or marijuana use~     that adds a 4-week course of tailored text messaging to a brief motivational intervention for~     13-18-year-old adolescents.~   "
12645|NCT03401320|"~     This is a Phase I, open label, dose escalation study designed to evaluate the~     pharmacokinetics, safety, and tolerability of single intramuscular injections of Letrozole~     ISM® at different strengths in voluntary healthy post menopausal women~   "
12712|NCT03400436|"~     Dietary supplements are an important contributor to overall nutrient exposures for a large~     proportion of the U.S. population. Currently no standardized method exists to measure their~     use and contribution to total nutrient intakes, substantially limiting the rigor and~     reproducibility of their measurement. The purpose of this proposed project is to develop a~     standardized, data-driven, and valid metric that can be to measure use of and nutrient~     exposures from dietary supplements for use in research, clinical, and monitoring settings.~   "
12646|NCT03401307|"~     OBJECTIVE To investigate neurodegeneration and demyelination in the central and peripheral~     nervous system in multiple sclerosis linked to disease progression and mechanisms that can~     explain different responses to Fampridine treatment in MS patients with walking disability.~      METHOD The study is a prospective cohort follow-up study with 98 participants with MS and~     walking disability. Participants are identified as responders or non-responders to Fampridine~     treatment prior to the study. Participants will undergo MRI of the cerebrum with lesion load~     quantification, neurophysiological tests comprised of motor evoked potentials and~     electroneurographic examination, blood samples examining KIR4.1 antibodies, brain derived~     neurotrophic factor (BDNF), myelin protein zero (MPZ), peripheral myelin protein 22 (PMP22),~     p75-nerve growth factor receptor (p75NGFR) and anti-myelin associated glycoprotein~     (anti-MAG). The presence of SORCS-3 gene mutation will also be examined, as will~     cerebrospinal fluid levels of myelin basic protein, neurofilament heavy and light chains.~     Functional test of Timed 25-foot walk test (T25FW) will identify response to Fampridine~     treatment. A functional test battery will further detail function of upper extremities and~     cognition.~      CONCLUSION This study will add to the understanding of neurodegeneration and demyelination in~     CNS and PNS in patients with MS having walking disability. This will impact clinical~     decision-making by improving organization of immunomodulatory treatment, identifying~     biomarkers thus facilitating earlier treatment and improving patient control, information and~     education.~   "
12647|NCT03401294|"~     Most patients with mCRC are treated with palliative chemotherapy and only a small number of~     patients with limited metastatic disease achieve long-term remission following~     metastasectomy. There is a growing need for more effective treatment in patients with~     liver-only mCRC to improve the rate of curative resection without compromising QOL.The~     current study is informed by our patient's needs. It aims to evaluate the rate of conversion~     therapy in patients with unresectable liver-only mCRC using the combination of FOLFOXIRI and~     bevacizumab and to assess the association between an early FDG-PT/CT response and other~     clinical and pathological biomarkers and hepatic metastasectomy.~   "
12648|NCT03401281|"~     This is a randomised trial in which healthy volunteers, men and women aged 50-75 years from~     the general community are randomized into one of three arms: participants will be provided~     with 50 gm extra virgin coconut oil, or 50 grams butter or 50 extra virgin olive oil to be~     eaten daily for a month. The food will be provided in the form of processed cheese to mask~     participants. The key outcome is blood low density lipoprotein cholesterol concentrations and~     secondary outcomes blood lipid profile (total cholesterol, high density lipoprotein~     cholesterol, triglycerides) and anthropometric measures: weight and waist circumference. This~     trial is powered to detect a difference of 0.5 mmol/L LDL-cholesterol difference between the~     trial arms.~   "
12649|NCT03401268|"~     Tolerability of home subcutaneous immunoglobulin (ScIG) for replacement therapy for~     hypogammaglobulinemia in allogeneic HCT patients. A financial analysis comparing the cost of~     ScIG with intravenous immunoglobulin (IVIG) will also be performed.~   "
12650|NCT03401255|"~     Preterm labor is the first cause of hospitalization during the pregnancy, and at the origin~     of more than 60 000 births before 37 weeks of amenorrhea every year in France. It is however~     difficult to predict if a patient consulting in emergencies with symptoms of preterm labor,~     will give birth prematurely or not. Current diagnostic tools to identify patients with high~     risk of premature delivery in 7 days are insufficient because of their low positive~     predictive value. Yet the neonatal complications in case of premature delivery are important,~     with respiratory distress syndrome, hyaline membrane disease, necrotizing enterocolitis,~     intraventricular hemorrhage and post-natal death. Recent studies suggested that the detection~     of the placental alpha microglobulin 1 (PAMG-1) in the vaginal secretions, by Partosure® test~     at the women presenting symptoms of preterm labor with intact membranes would indicate that a~     premature spontaneous delivery could arise in 7 days with a good positive predictive~     value.The test is interesting all the more as the repetition of the prenatal cures of~     corticosteroids, aiming at the fetal lung maturation, is this day more recommended and as the~     beneficial effect takes place within 24 hours in 7 days following their administration. It~     seems thus essential to make studies to specify the interest of this test at the patients~     presenting a preterm labor. This study aims at estimating the diagnostic performance of the~     test of detection of PAMG-1 in the prediction of a delivery in 7 days, at the patients~     presenting symptoms of preterm labor.~   "
12651|NCT03401242|"~     CARBEHPAD is a multicentric randomized prevalence study aiming to assess the frequency of~     Enterobacteriaceae (ESLB) and carbapenemase producing Enterobacteriaceae (CPE) carriage in~     Pays de la Loire nursing homes.~      A sample of 50 nursing homes (NH) in Pays de la Loire will be randomly selected for~     inclusion, and a sample of 1/3 of residents of these NH will be screened for ESBL and/or CPE~     fecal carriage. Epidemiological data on each resident will be collected to identify risk~     factors for such carriage.~   "
12652|NCT03401229|"~     The aim of this present study is to investigate the use of benralizumab as treatment for~     severe nasal polyposis. The effect of benralizumab on nasal polyps will be assessed over a 56~     weeks of treatment period in patients with severe bilateral nasal polyposis who are still~     symptomatic despite standard of care therapy, i.e current use of intranasal corticosteroids~     (INCS) and prior surgery and/or use of systemic corticosteroids. The first 200 patients that~     complete the 56-week treatment will have a 6 month follow-up (FU) period without dosing.~   "
12653|NCT03401216|"~     The objective of this study is to evaluate the rate of SYNERGY 48 mm stent strut coverage and~     assess neointimal progression via OCT measurement in patients who underwent PCI.~   "
12654|NCT03401203|"~     This study is to establish the primary hypothesis that debulking with rotational atherectomy~     (RA) followed by balloon angioplasty (BA) is superior to BA alone for lesion preparation in~     patients with coronary in-stent restenosis (ISR) regarding the Optical coherence~     tomography(OCT)-measured in-segment minimal lumen area at 1 year.~   "
12749|NCT03399955|"~     This is an open label, randomized non comparative phase II clinical trial conducted on~     parallel groups, to assess the safety and efficacy of the combination of Paromomycin (20~     mg/kg/d) IM for 14 days and Miltefosine (allometric dosing) oral for 42 days, and a~     combination of AmBisome® (20 mg/kg total dose) IV over 7 days and Miltefosine oral for 28~     days (allometric dosing) for the treatment of PKDL patients in Sudan.~   "
12655|NCT03401190|"~     This open-label, dose-response study will evaluate the safety and efficacy of CM4620-IE in~     patients with acute pancreatitis and accompanying SIRS. The study will consist of two phases.~     The first phase will consist of 2 cohorts that will be enrolled concurrently. Cohort 1 will~     consist of 4 female patients who will be randomized 3:1 to receive CM4620-IE plus supportive~     care versus supportive care alone. Cohort 2 will consist of 4 male patients who will be~     randomized 3:1 to receive CM4620-IE plus supportive care versus supportive care alone. The~     second phase will consist of 2 cohorts. Cohort 3 will consist of 8 female patients who will~     be randomized 3:1 to receive CM4620-IE plus supportive care versus supportive care alone.~     Cohort 4 will consist of 8 male patients who will be randomized 3:1 to receive CM4620-IE plus~     supportive care versus supportive care alone.~   "
12656|NCT03401177|"~     this study evaluates the addition of initial short term NSAID treatment to physiotherapy~     prescribed exercise treatment in patient with early phase tendinopathy. Half of the~     participants will initially receive NSAID (naproxen) for 7 days, while the other half will~     receive a placebo, where after both groups will be subjected to 3 months heavy slow~     resistance training.~   "
12657|NCT03401151|"~     The mechanisms behind heart failure are largely unknown. Despite an increasing arsenal of~     pharmacological therapies, cardiovascular disease is still the most common cause of death in~     the western world, which demonstrates a pronounced need for more patient-related mechanistic~     research. Cachexia and limited exercise capacity are the symptoms that best match prediction~     of heart failure, both of which are symptoms involving a dysfunctional skeletal muscle. An~     increased understanding of the mechanisms and signaling pathways connects the failure heart~     with skeletal muscle dysfunction is likely to lead both to discoveries of prognostic factors~     and possible therapeutic options.~      The study is a prospective, non-blinded, study. The study will consist of the assignment of~     patients with heart failure, New York Heart Association (NYHA) III-IV, 60-80 years old. One~     hundred (100) patients will be enrolled in this study.~   "
12658|NCT03401138|"~     Background: Fracture of the hip is a potentially fatal event in an elderly, frail, highly~     comorbid patient group suffering from dehydration and hypovolemia, and it carries a risk that~     equals major trauma in young patients in regard of physiological insult and severity, yet no~     preoperative resuscitation and transfusion strategy is available. An important goal of~     hemodynamic monitoring and resuscitation is early detection of insufficient tissue perfusion~     and oxygenation. The peripheral perfusion index reflects changes in peripheral perfusion and~     blood volume and a decreased peripheral perfusion index predicts surgical complications and~     morbidity in acute surgical and septic shock patients. The research group hypothesize that~     elderly frail patients with a fracture of the hip suffer from hypovolemia and peripheral~     hypoperfusion of varying degrees and accordingly respond to controlled fluid resuscitation~     and that the non-invasive peripheral perfusion index will serve as an early predictor of a~     deteriorated circulation in reflection of stroke volume.~      Methods: The main objective of this prospective observational study is to assess to what~     extend patients with fracture of the hip suffer from hypovolemia and respond to a fluid~     challenge. The secondary objectives are to evaluate correlation between the~     minimally-invasive measurements of stroke volume and blood volume and the non-invasive~     measurement of peripheral perfusion index and near-infrared spectroscopy, as well as~     prevalence of postoperative complications and mortality. Fifty consecutive patients over the~     age of 65 years, presenting with a hip fracture, treated in a multimodal fast-track regimen,~     will be included when written informed consent is available. All patients will receive~     epidural analgesia and preoperative stroke volume-guided hemodynamic optimization. Blood~     volume measurements are performed and all patients are monitored with peripheral perfusion~     index and near-infrared spectroscopy.~      Discussion: This is likely the first study to address clinically applicable hemodynamic~     monitoring and resuscitation in patients with fracture of the hip where adequate~     resuscitation is easily missed. The study group aim to evaluate the feasibility of~     preoperative stroke volume-guided hemodynamic optimization in the context of minimally- and~     non-invasive monitoring of peripheral perfusion and blood volume measurements.~   "
12659|NCT03401125|"~     Sickle cell patients have a high prevalence of alloimmunization. This high rate of~     alloimmunization can be partially explained by the existence of an antigenic difference~     between the predominantly Caucasian donor population and the sickle cell patients of African~     origin. Genetic and environmental risk factors have also been described.~      The main risk factors that have been shown in retrospective or cross-sectional studies are~     some HLA alleles, the age of the patient, the number of leukocyte-depleted erythrocyte~     concentrates (CED) transfused, the number of transfusion episodes, the age of the CEDs, the~     existence of an inflammatory event at the time of transfusion and the presence of~     anti-erythrocyte autoantibodies.There is also evidence of an impaired TH response but the~     underlying immunological mechanism is not fully understood.~      The aim of this study is to study the prevalence and the risk factors for anti-erythrocyte~     alloimmunization in pediatric and adult patients with Sickle Cell Disease (with a SS~     genotype) who are being followed at Queen Fabiola University Children's Hospital (HUDERF) and~     at the CHU Brugmann Hospital. The identification of risk factors would allow the~     investigators to improve, or at least adapt, their transfusion policy to certain clinical or~     immuno-haematological situations.~   "
12660|NCT03401112|"~     A Phase 2a randomized, placebo-controlled, multicenter study of orally administered IMR-687~     in adults with Sickle Cell Anaemia (SCA).~   "
12661|NCT03401099|"~     Current guidelines recommend radiofrequency catheter ablation of the cavotricuspid isthmus as~     treatment for symptomatic/drug-refractory atrial flutter, in spite of the fact that~     recurrences of flutter and incidence of post-ablation atrial fibrillation are common.~      In this study, the investigators asses the hypothesis that the use of cryoballoon Pulmonary~     Vein Isolation ('novel' treatment) to achieve the electrical disconnection between the~     pulmonary veins and the heart will lead to higher rates of freedom from abnormal heart~     rhythms (atrial flutter, atrial fibrillation, or atrial tachycardia) and more improved~     quality of life than treatment using heat energy (radiofrequency ablation) directed at the~     cavotricuspid isthmus ('conventional treatment').~   "
12662|NCT03401086|"~     Breast cancer is a standout amongst the most widely recognized cancer among women. It is~     observed that upper extremity lymphedema is one of the most dangerous and prevalent~     complication following breast cancer surgery which prompts functional impairment,~     psychological disaster and social problems~      This study aimed to compare the effects of Kinesio taping and the pressure garment~     application on secondary lymphedema of the upper extremity and quality of life following~     mastectomy after breast cancer.~      Material and Methods: In this experimental study with pre and post-tests, 66 women with~     lymphedema following mastectomy were randomly allocated to Kinesio taping (KT) group (n=33)~     and pressure garment (PG) group (n=33). The KT group received Kinesio taping application,~     while the PG group received pressure garment (40-60 mmHg) for at least 15-18 hours per day~     through the study. All patients were evaluated to record the changes of the limb~     circumference, Shoulder Pain and Disability Index (SPADI), hand grip strength and quality of~     life at baseline and end of intervention.~   "
13700|NCT03387540|"~     Immune checkpoint inhibitors (ICIs) might have high grade immune-related adverse events~     (irAEs) on the cardio-vascular system. This study investigates reports of cardio-vascular~     toxicity with treatment including anti-PD1, Anti-PDL-1, and Anti CTLA4 classes using the~     World Health Organization (WHO) database VigiBase.~   "
12663|NCT03401073|"~     The objective of this study is to develop a rationale for the selective treatment of small~     fiber neuropathy with immune globulin (IVIG) in the appropriate patients.~      The investigators hypothesize that individuals with auto-antibodies targeting neuronal~     antigens (TS-HDS and FGFR3) and confirmed evidence of small fiber neuropathy (by skin biopsy~     analysis of intra-epidermal nerve fiber density) will have an improvement in both nerve fiber~     density and pain after treatment with immune globulin.~      The co-primary endpoints will be a change in neuropathic pain (by VAS pain score) and a~     change in intra-epidermal nerve fiber density (by punch skin biopsy).~      The data gained from this pilot study will establish a rationale, with an appropriate~     screening test, for the use of immune globulin for the treatment of small fiber neuropathy.~   "
12664|NCT03401060|"~     The study is looking at the efficacy of subcutaneously administrated denosumab 60 mg every 6~     months versus placebo after 3 years, by analyze of lumbar spine bone mineral density (BMD) in~     systemic mastocytosis.~      Investigators hypothesize that use of denosumab subcutaneously in patients with osteoporosis~     related to systemic mastocytosis is effective and safe to improve bone mineral density and~     prevent new bone events, based on targeted specific RANKL secretion by mast cells and short~     half-life of denosumab.~   "
12665|NCT03401047|"~     The purpose of this study is to learn how a hormone called estradiol (estrogen) affects the~     levels of luteinizing hormone (LH) and follicle stimulating hormone (FSH) in women with~     polycystic ovary syndrome (PCOS). The study will assess whether estradiol-induced LH and FSH~     release is impaired in women with PCOS.~   "
12666|NCT03401034|"~     The MARIEplus study is a prospective cohort of breast cancer patients recruited into the~     MARIE (Mamma Carcinoma Risk factor InvEstigation) study, a population-based case-control~     study of breast cancer conducted in two German study regions, Hansestadt Hamburg and~     Rhine-Neckar-Karlsruhe (RNK) region. Participants were identified through participating~     clinics and the Hamburg cancer registry between January 1st, 2001 and September 30th, 2005 in~     Hamburg and between August 1st, 2002 and July 31st, 2005 in the RNK study region. Patients~     were aged 50-74 years at histologically confirmed primary invasive (stages I to IV) or in~     situ breast tumor (stage 0). Comprehensive information on demographic, socio-economic, and~     lifestyle factors was collected at multiple time points: at recruitment by a standardized~     face-to-face interview and at follow-up median 6 years as well as 11 years later using~     computer assisted telephone interview.~      Vital status was assessed in 2009 and again in 2015 via the population registries and causes~     of death were obtained from death certificates and coded according to the 10th revision of~     the International Statistical Classification of Diseases and Related Health Problems~     (ICD-10).~      Information on the clinical course was abstracted from medical records to verify clinical~     events either self-reported in follow-up interviews or reported by treating physicians.~      The studies were approved by the ethics committee of the University of Heidelberg and the~     University of Hamburg and conducted in agreement with the Helsinki Declaration. Written~     informed consent was provided by all participants at baseline and during follow-up.~      The primary objectives of this study are~        -  To assess the association of modifiable lifestyle factors and personal factors,~          including BMI, diet, physical activity, tobacco and alcohol use, menopausal hormone~          therapy, socioeconomic status, with breast cancer survival, overall and according to~          tumor type, after accounting for established prognostic factors.~        -  To examine the influence of genetic variants on breast cancer relapse and survival~        -  To assess the association of lifestyle factors and their changes in the course of~          survivorship on subsequent breast cancer prognosis.~        -  To assess the individual and combined association of inflammation/metabolic biomarkers~          as well as changes in their serum levels with subsequent breast cancer prognosis overall~          and according to tumor type.~        -  To assess whether and to what extent the associations between breast cancer prognosis~          and lifestyle factors and/or their changes are mediated by circulating biomarker levels.~   "
12667|NCT03401021|"~     This study aims to use a cross-sectional study and semi-structured interview to explore level~     of intention to quit smoking among male smoking partners of Chinese couples planning for~     pregnancy, and further explore factors associated with their quit intention.~   "
12668|NCT03401008|"~     Context: Acromegaly is the rare condition (3 to 4 new cases per million per year) due to~     Growth Hormone (GH) overproduction by a somatotrope pituitary adenoma, resulting in Insulin~     Growth Factor 1 (IGF-1) excess. Consequently, many tissues of the organism become~     hypertrophied. Hypertrophy of gingival and dental tissues can lead to alteration of oral~     health. However, there are very few published data concerning oral impact of acromegaly.~      Objective: To do the most accurate clinical and radiological state of oral manifestations in~     the series of prevalent acromegaly patients followed in the endocrinology service of the CHU~     of Clermont-Ferrand.~   "
12669|NCT03400995|"~     This phase I study is to assess the mass balance recovery after a single oral dose of~     [14C]-AK0529 in healthy male subjects.~   "
12670|NCT03400982|"~     In men, the hope of lower life, the absence of equivalent of menopause and the existence of a~     higher peak bone mass are the three factors that explain the lower incidence of osteoporosis~     in men.~   "
12671|NCT03400969|"~     This study compares the effectiveness of 3 different oral moisturizers; 17% watery solution~     of glycerol, OGT oral spray, Aequasyal, and a newly developed Product, Salient.~   "
12672|NCT03400956|"~     The primary objective of this study is to show superiority of vilaprisan in the treatment of~     heavy menstrual bleeding (HMB) in subjects with uterine fibroids compared to placebo.~      The secondary objectives of this study are to additionally evaluate the efficacy and safety~     of vilaprisan in subjects with uterine fibroids.~   "
12673|NCT03400943|"~     The primary objective of this study is to show superiority in the treatment of HMB of~     vilaprisan in subjects with uterine fibroids compared to placebo.~      The secondary objectives of this study are to additionally evaluate the efficacy and safety~     of vilaprisan in subjects with uterine fibroids.~   "
12674|NCT03400930|"~     INTRODUCTION~      In 2014, 50 million children under 5 suffered from acute malnutrition, of which 16 million~     suffered from SAM, most of them living in sub-Saharan Africa and Southeast Asia. SAM children~     have higher risk of mortality (relative risk between 5 and 20). It is an underlying factor in~     over 50% of the 10 - 11 million preventable deaths per year among children under five. At~     present, 65 countries have implemented WHO recommendations for SAM treatment (both in-patient~     for complicated cases and outpatient for uncomplicated cases) but these programs have very~     low coverage, reaching only around 10 - 15 % of SAM children.~      In 2009 the World Health Organization (WHO) and the United Nations Children's Fund (UNICEF)~     issued a joint statement in an effort to harmonize the application of anthropometric criteria~     for SAM diagnosis and monitoring in child aged 6 - 59 months; the statement presents~     recommended cut-offs, and summarizes the rational for the adoption, of the following two~     anthropometric criteria:~        1. Weight-for-Height Z-Score (WHZ): WHO and UNICEF recommend the use of a cut-off for~          weight-for-height of below -3 standard deviations (SD) of the WHO standards to identify~          infants and children as having SAM. Additionally, analysis of existing data show that~          children with a WHZ < -3 have a highly elevated risk of death.~        2. Mid-Upper Arm Circumference (MUAC): WHO standards for the MUAC-for-age show that in a~          well-nourished population there are very few children aged 6 - 59 months with a MUAC~          less than 115 mm. Children with a MUAC less than 115 mm have a highly elevated risk of~          death compared to those who are above. Thus it is recommended to [use] the cut-off point~          [of] 115 mm to define SAM with MUAC.~      GENERAL OBJECTIVE~      To generate new evidence on pathophysiological process, nutritional needs and risks~     associated with different types of anthropometric deficits in children under 5, in order to~     optimize the diagnosis and treatment of SAM.~      SPECIFIC OBJECTIVES~        -  To compare nutritional status, metabolism, pathophysiological process and risks in~          different types of SAM anthropometric diagnosis, with or without concomitant stunting~          (growth retardation).~        -  To analyze the extent to which current SAM treatment is promoting recovery and healthy~          growth in different categories of children.~        -  To evaluate the relevance of current discharge criteria used in nutrition programs and~          their association with metabolic recovery, in different age groups and among those who~          are stunted.~        -  To test novel rapid tests of emerging biomarkers predicting long-term outcomes and~          mortality risk in the field.~      METHODOLOGY~      A wide range of supplementary information related to nutritional status, body composition,~     metabolic and immune status, including emerging biomarkers of metabolic deprivation and~     vulnerability, will be collected besides anthropometry during prospective observational~     studies. They will be collected with minimum level of invasiveness, compatible with field~     work requirements in the humanitarian context.~      Phase 1: Cross-sectional surveys. Phase 2: Prospective cohort studies involving SAM children~     between 6 months and 5 years old.~      Children admitted as SAM at the nutrition centers will be enrolled into the cohort. The~     follow up duration will be at least three months.~      EXPECTED OUTCOMES~        -  Confirmation of current hypotheses related to:~             1. possible misdiagnosis of SAM made by MUAC or WHZ criteria,~             2. varying degree of severity and need for admission to treatment of the different~               types of diagnosis,~             3. underlying heterogeneity of the pathophysiology.~        -  Generation of new algorithms for the assessment and classification of malnourished~          children, based on the combined use of emerging biomarkers and anthropometric measures,~          or on the modification of anthropometric criteria.~        -  Generation of new treatment paradigms based on the predictive value of biomarkers in~          combination with traditional anthropometric measures. This will enable us to assess the~          power of current treatment regimens to promote long-term weight gain and growth and will~          allow us to tailor treatment to the physiological needs of the child.~   "
12675|NCT03400917|"~     This is a single-arm, open-label phase II clinical trial in which approximately 55 patients~     with newly diagnosed glioblastoma (GBM) will be enrolled with the intent to receive an~     autologous dendritic cell vaccine consisting of autologous dendritic cells loaded with~     autologous tumor-associated antigens (AV-GBM-1).~   "
12686|NCT03400774|"~     This study aims to investigate the effect of moderate intensity stair-climbing bouts of~     various durations on postprandial blood glucose. Participants will perform a standard oral~     glucose tolerance test (OGTT) using 75g of dextrose and with fingerstick blood glucose~     measurements at baseline and every 15 minutes after consuming the drink for one hour. On~     separate subsequent visits, participants will perform the same OGTT combined with three~     stair-climbing bouts lasting 1, 3, and 10 minutes starting 27, 25, and 18 minutes~     respectively after finishing the drink. Participants performed maximal aerobic capacity~     (VO2max) using a ramp treadmill test in order to assess the relative intensity of each~     stairclimbing trial.~   "
13331|NCT03392363|"~     The purpose of this prospective study is to evaluate the efficacy of the ResAppDx software~     application in the diagnosis of childhood acute respiratory disease, including pneumonia,~     bronchiolitis, asthma/reactive airways disease, croup, lower respiratory tract disease~     (LRTD), viral lower respiratory tract infection (vLRTI), and upper respiratory tract disease~     (URTD).~   "
12676|NCT03400904|"~     Rationale Prolonged mechanical ventilation (MV) is common in patients with severe Brain~     Injury (BI). Guidelines for the management of extubation are largely lacking for patients~     with BI, and the role of tracheostomy is highly uncertain. More important, data on practice~     of management of extubation is yet underreported, as is the use of tracheotomy in this~     specific subset of critical care patients.~      Objective The objective of this prospective observational study is to describe the management~     of extubation and tracheostomy in intensive care unit (ICU) patients with BI. The aim is to~     describe the incidence of extubation failure and the rate of tracheostomy.~      Study design The Extubation strategies in Neuro-Intensive care unit patients, and~     associations with Outcomes (ENIO) is an observational multicentre international cohort~     study.~      Study population The investigators will include patients undergoing BI, with an initial~     Glasgow Coma Score ≤ 12 and with a delivered duration of mechanical ventilation (MV) ≥ 24~     hours at ICU admission. The inclusion period will last 6 months in total, and each centre is~     expected to include at least 24 patients during this period. With over 60 ICUs participating~     worldwide, we expect to include 1500 patients.~      Main parameters Parameters to be collected include: general neurological management,~     ventilatory management, general ICU complications, specific data on extubation and~     tracheostomy, general in-ICU outcomes and in-hospital mortality.~      Nature and extent of the burden and risks associated with participation Because of the~     observational design of the study using routinely collected data, there is no additional~     burden for the patient. Collection of data from ICU charts and/or (written or electronic)~     medical records systems bears no risk to the patients.~   "
12677|NCT03400891|"~     Because fruit and vegetables (FV) intake of children of Vitoria city is low, a controlled~     intervention program was proposed at school level. The intervention was based on the Theory~     of Planned Behavior (TPB) as long as behavioral theories have been proved to be the most~     effective changing infant FV intake pattern. The main purpose of the study is to evaluate the~     effectiveness of an intervention program based on TPB and aimed to increase FV consumption in~     schoolchildren aged 8 to 10. For that aim, eligible classrooms from different schools were~     randomly assigned to the intervention (n=86) or control (n=86) group. The intervention group~     received 14 sessions of 60 minutes during 9 months of an academic year. Sessions, designed by~     a multidisciplinary team, are based on TPB and aimed to modify determinants of behavior~     (attitudes, subjective norms, perceived behavioral control, intention of consumption), and~     intake of FV itself. Change in fruit and vegetable intake and determinants of eating behavior~     were evaluated at 9 months of intervention using validated surveys, 7 day food records, 24~     hour reminders and questionnaires. This study will provide a valid and useful tool to achieve~     changes in the consumption of FV at school level. A negative result will be useful to help~     redefining new strategies in the framework of changing habits in the consumption of FV.~   "
12678|NCT03400878|"~     Background: Investigators at Bandim Health Project (BHP, www.bandim.org) in Guinea-Bissau~     have shown in several randomized trials that the Bacille-Calmette-Guérin (BCG) vaccine~     against tuberculosis (TB) is associated with reduced mortality in the first months of life.~      BCG is a live attenuated vaccine, which means that it consists of active tuberculosis~     bacteria that are not capable of infecting a human with TB. BCG has been grown and maintained~     at many different laboratories all over the world using slightly different laboratory~     techniques. Due to the accumulation of genetic mutations in the different BCG strains, many~     variants of the vaccine exists today. These have different properties when it comes to immune~     response, side effects, protection against TB and scar formation. The BCG scar status after~     vaccination is a good marker for the non-specific effects of the vaccine; among~     BCG-vaccinated infants, those with a BCG scar have improved survival. The investigators~     hypothesize that the different types of BCG vary in terms of the strength of the non-specific~     effects and thus the impact on overall morbidity and mortality.~      In the trial, the investigators will compare the two most widely used BCG strains in the~     world, BCG-Russia and BCG-Japan, with respect to their non-specific effects on morbidity and~     mortality. As an addition, the investigators will study the effect of maternal BCG~     vaccination on the subsequent effect of BCG-vaccination in the offspring, since there are~     indications that the maternal BCG scar status primes for a stronger non-specific response in~     the offspring.~   "
12679|NCT03400865|"~     The purpose of this study is to preliminarily evaluate the safety and efficacy of cabergoline~     combined hydroxychloroquine/chloroquine(HCQ/CQ) therapy for cabergoline-Resistant~     Prolactinomas~   "
12680|NCT03400852|"~     This is a multicenter, double blind, placebo controlled, multiple dose study to examine the~     safety and efficacy of MNK-1411 in male subjects 4 to 8 years of age (inclusive) with~     Duchenne Muscular Dystrophy (DMD).~   "
12681|NCT03400839|"~     This prospective cohort study will investigate whether progression of the interstitial lung~     diseases is related to specific clinical endpoints and their changes over time. Longitudinal~     data of patients will be compared to an age-matched control group during a follow-up of at~     least two years.~   "
12682|NCT03400826|"~     The study aims to study the effect of simvastatin on the size of uterine fibroids.~   "
12683|NCT03400813|"~     Millions people, all over the world, are admitted in the Emergency Department after a trauma~     or simply to receive medical cares. In France, it represents 10 million patients. Probably~     because of stress associated with the event, 20% will suffer a combination of non-specifics~     symptoms which persist for many months and with daily life quality impairment. The~     investigators hypothesize that an early intervention, such as Eye-Movement, Desensitization~     and Reprocessing (EMDR) could be performed in the ED and could prevent the occurrence of~     these symptoms.~   "
12684|NCT03400800|"~     This is a Phase III, placebo-controlled, double-blind, randomized study in participants with~     ASCVD or ASCVD-Risk equivalents and elevated LDL-C despite maximum tolerated dose of LDL-C~     lowering therapies to evaluate the efficacy, safety, and tolerability of subcutaneous (SC)~     inclisiran injection(s). The study will be an international multicenter study (non-United~     States).~   "
12685|NCT03400787|"~     The primary objective of the LATERA RCT is to demonstrate the superiority of the Latera~     Implant to improve nasal breathing, compared with a Sham Control procedure.~   "
12708|NCT03400488|"~     This is a Phase I study to investigate the safety, tolerability, pharmacokinetics (PK) and~     pharmacodynamics (PD) of the novel compound, AZD5718 in healthy Japanese men. The results~     from this study will form the basis for decisions on future studies.~   "
12687|NCT03400761|"~     Several studies performed in elite endurance athletes have shown that running performance may~     be determined by a low fat mass in the overall population.~      The Course de l'Escalade occurs yearly during the first week-end of December. This race~     takes place in the city of Geneva. The distance of this race is 7.3 km for all men and elite~     women, and 4.8 km for non-elite women. During this race, measurement of body composition by~     biolelectrical impedance analyses (BIA) were performed in volunteer, between December 1999~     and 2017.~      Hypothesis :~      We hypothesize that:~        1. A low fat mass is associated with a slower running time, when adjusting for age, body~          weight, and habitual physical exercise.~        2. An increase in fat mass over time increases running time over the years~      Objectives :~        1. To evaluate whether total and regional body composition is associated with running time~          at the Course de l'Escalade.~        2. To determine whether changes in body composition with progressive aging lead to changes~          in running time.~   "
12688|NCT03400748|"~     Evaluate the preliminary safety and performance of the Electrosurgery Applicator (ANET~     device) during and after bronchoscopic ablation of a target pulmonary nodule/tumor.~   "
12689|NCT03400735|"~     It is planned to compare the efficacy and safety of cefdinir and cefdinir/clavulanic acide~     treatments in acute exacerbation of chronic bronchitis (AECB) and community-acquired~     pneumoniae (CAP) patients.~   "
12690|NCT03400722|"~     Patients with infertility of the older age group of 37-42 years - a large cohort of patients~     of reproductive medicine. Two possible causes reduce their probability of pregnancy - an~     increasing age and a decrease of the ovarian reserve. In these conditions, the early receipt~     of embryos for future transfer can serve as a correct strategy for treating infertility in~     this category of patients. According to statistical data, patients of the 37-42-year-old age~     group need 3-5 blastocysts, out of them 1-2 euploid to achieve pregnancy.~      The POSEIDON group of researchers identified a group of 2b patients with a suboptimal~     response to the induction of superovulation in IVF programs - patients older than 35 years~     with a normal ovarian reserve (the number of antral follicles greater than 5 and~     Anti-Müllerian hormone (AMH) greater than 1.2 ng / ml), resulting in 4-9 oocytes after a~     standard ovarian stimulation.~      In this situation standard stimulation protocols can stretch the process of obtaining embryos~     indefinitely, during which the patient will move to another age category with a decrease in~     the likelihood of pregnancy.~      Thus, these patients are shown the fastest reception of oocytes and the accumulation of~     embryos, which can be done using double ovarian stimulation in the same menstrual cycle.~      The aim of the study is to compare the different schemes of double stimulation in patients~     with infertility of the older age group of 37-42 years with the preceding suboptimal~     response.~      Group 1 - patients of the DUOSTIM group. Group 2 - Patients of the Shanghai Protocol.~      The investigated parameters - primary outcome measures: total number of retrieved oocytes per~     cycle, secondary outcome measures: total number of blastocyst per cycle, number of cycles~     with double ovarian stimulation required to obtain 3-5 blastocyst, time until embryo~     transfer, pregnancy rate and birth rate This is a prospective randomized non-blinded clinical~     study.~   "
12691|NCT03400709|"~     Introduction. Cisplatin-induced ototoxicity is a very frequent event and its consequences can~     cause a lot of deterioration in patients. Early diagnosis is essential because it would allow~     the appropriate implementation of strategies to reduce its effect. Among these~     N-acetylcysteine, an antioxidant agent that has shown otoprotective effect. Study design.~     Randomized, parallel design and placebo controlled clinical trial. Methods. Patients with~     head and neck cancer who require treatment with cisplatin were enrolled in 2 branches: a~     control group that receives a placebo and experimental group that receives the drug.~     High-frequency audiometries (6 - 16 KHz) are performed before, during and after the treatment~     finalization.~   "
12692|NCT03400696|"~     Excess weight is a major risk factor underlying leading causes of death globally, including~     cardiovascular disease, type 2 diabetes, and some cancers. Among participants assigned to the~     same lifestyle intervention arms in prior weight loss randomized controlled trials, large~     inter-individual differences in weight loss success have been observed, ranging from >50lbs~     of weight loss to >10lbs of weight gain. Both genetic and non-genetic factors underlying~     differential adherence and weight loss success are poorly understood.~   "
12693|NCT03400683|"~     The Patient are divided into 3 groups group 1 included 50 cases using misoprostol only. group~     2 included also 50 cases in which using misoprostol with letrozole. Group3 included also 50~     cases in which using misoprostol with Foleys catheter for termination of second trimesteric~     abortion between 14 and 24 weeks~   "
12694|NCT03400670|"~     is to compare introduction of two different NCPAP methods in terms of mechanical ventilation~     (MV) need (non-invasive respiratory support failure) and surfactant need within the first 72~     hours of life in preterm infants with Respiratory Distress Syndrome (RDS) at 26-30 weeks of~     gestation.~   "
12695|NCT03400657|"~     This is a prospective, multicenter, non-interventional, controlled clinical study. Evaluate~     MDT performance and benefit analysis in patients with advanced gastric or colorectal cancer~     after MDT discussion under real medical practice.~   "
12696|NCT03400644|"~     This is a randomized controlled trial to assess the use of rigid neck collar postoperatively.~     It consists of patients with cervical myelopathy undergoing open-door laminoplasty with~     titanium arch plates. Patients are divided into two groups: one group are not using rigid~     neck collar whereas the second group of patients wear rigid neck collar for three weeks~     postoperatively. Both groups of patients will then be assessed at fixed intervals. Clinical~     assessments include the cervical spine range of motion, any axial neck pain and also a full~     neurological examination. Radiographs will be used to assess for any complications. Cervical~     spine alignment and relevant questionnaires will be done and recorded. These results will~     help to conclude whether we can avoid the use of rigid cervical collars postoperatively, in~     view of the associated problems arising from restricted neck movement.~   "
12697|NCT03400631|"~     Twenty participants with severe arthritis will be enrolled. For the first week participants~     will either be injected with dextrose or just have fluid withdrawn for testing. The remaining~     participants will be given dextrose injection at the end of the week. After one week dextrose~     injections will be given at one, two, three, four, five, and six months. Fluid will be~     withdrawn from the knee at time zero, one week, and three months. The hypothesis is that~     dextrose injection will cause a change in proteins in the knee consistent with improved~     repair signals, along with improving knee pain and function. .~   "
12709|NCT03400475|"~     This study seeks to test the recently discovered anti-inflammatory action of statins on~     inflamed mucosa surrounding dental implants.~      Hypothesis: The application of 1.2% simvastatin gel will decrease peri-implant inflammation.~      The pilot study will involve 44 subjects divided into a test and control group. The test~     group shall receive topical simvastatin gel administered around the implant with a blunt~     tipped needle. The control group will receive a placebo.~      Inflammatory state shall be determined at baseline as well as follow up visits at 24 hours, 1~     week, and 1 month by clinical indices of inflammation as well as biochemical markers of~     inflammation gathered from around the implants.~   "
12698|NCT03400618|"~     The aim of this study is to analyse the effect of a diet with a moderate amount of~     carbohydrates and compare it with a traditional diabetic diet with a higher content of~     carbohydrates on mean glucose level, high and low glucose levels, and the risk of~     ketoacidosis in patients with type 1 diabetes. The glucose levels will be measured by blinded~     continuous glucose monitoring (CGM).~      The trial has a cross-over design and 12 weeks in duration, where patients will be randomized~     to; 1) a diet with moderate carbohydrate content for 4 weeks and 2) a traditional diabetes~     diet for 4 weeks and with a wash-out period between for 4 weeks. The two diets will both be~     healthy and planned by a dietitian. There will be 50 subjects included in the study.~   "
12699|NCT03400605|"~     In Toronto Ontario, the Parkdale Community Health Centre operates a community outreach~     program entitled Parkdale Parents' Primary Prevention Project (5P's). The 5P's provides~     weekly pre- and post-natal support and education programs for clients. This includes an~     infant feeding program for mothers with infants 0-6 months (Feeding Tiny Souls). The 5P's has~     a diverse client-base; the program is aimed at women who are in challenging life~     circumstances, therefore, clients may include low-income or single mothers and newcomers to~     Canada.~      The aim of this project is to investigate the incidence, duration and exclusivity of~     breastfeeding and timely complementary feeding based on level of maternal participation in~     components of a pre and postnatal community outreach program. Exploring infant feeding~     practices is an evaluation component that will not only characterize infant feeding practices~     within a vulnerable population, but will elucidate whether there are areas of concern that~     need to be expanded upon within pre or postnatal programming. A prospective infant feeding~     questionnaire will be administered to participants at 2 weeks and at 2, 4 and 6 months~     postpartum. The study population will consist of women who enrolled in 5P's prenatally. The~     hypothesis is that exclusive breastfeeding rates will be low, but higher breastfeeding rates~     will be observed among women who utilize provided postnatal services more readily.~   "
12700|NCT03400592|"~     The trial aims to evaluate the efficacy and safety of adding nimotuzumab to irinotecan after~     failure of first-line treatment in recurrent or metastatic gastric adenocarcinoma with~     overexpression of EGFR, and search for the effective biomarkers for nimotuzumab efficacy in~     gastric cancer.~   "
12701|NCT03400579|"~     Prospective, single center, single arm pilot study evaluating the feasibility of delivering~     remote ischemic conditioning (RIC) by emergency medical services (EMS) in the prehospital~     setting. Eligible patients will have chest pain or anginal equivalent symptoms and require~     ground ambulance transport to the hospital. All subjects will undergo the standard RIC~     procedure (i.e., up to four cycles of alternating 5-min inflation and 5-min deflation) with~     the autoRIC® device (CellAegis Devices, Inc., Toronto, Ontario). The primary objective is to~     evaluate the number of cycles of RIC completed in patients having the procedure initiated by~     EMS in the prehospital setting.~   "
12702|NCT03400566|"~     The aim of this cluster randomized control trial is to test the efficacy of providing~     experience of a target novel vegetable within the context of an interactive story time to~     increase intake of the target novel vegetable in preschool aged children (aged 2-5 years).~   "
12703|NCT03400553|"~     Thoracic pain can be caused by a life threatening disease as for instance a heart attack.~     Fast diagnosis and treatment is necessary for an advantageous clinical outcome. When a~     patient enters the emergency unit, an electrocardiogram (ECG) can diagnose a heart attack by~     recording the electrical activity of the patients' heart. However, an increasing number of~     patients with an acute myocardial infarction (AMI) are presenting without significant~     abnormalities on ECG In the latter group, diagnosis is dependent of elevated biochemical~     markers of myocardiocyte necrosis in the blood such as troponin. Generally, troponins are~     determined in blood and are analyzed by radiometry or at the hospital's laboratory. Time loss~     in the acquisition of troponin levels can occur during the workflow due to blood sampling~     difficulties, transport of the blood samples, processing in the laboratory, and processes~     inherent to the measuring assays. Roche developed a portable point-of-care (POC) device that~     determines troponin-T in a few minutes by using small volumes of the patient's blood with the~     added value that this device can be used in a pre-hospital setting which might save a~     significant amount of time in determining troponin levels.In this way, a faster diagnosis of~     AMI can be made improving patients' outcome.~   "
12704|NCT03400540|"~     The aim of this study is to T to compare the effectiveness of producing a pelvic floor muscle~     contraction by different verbal instruction. Pelvic floor muscle contraction will be measured~     displacement of the pelvic floor when imaged on ultrasound.~   "
12705|NCT03400527|"~     The purpose of this study is to determine the effects of self directed exercise on pain and~     function reported in patients with Fibromyalgia both in the short term and long term.~     Previous studies have shown that patients with fibromyalgia respond better to a single~     session of self directed exercise compared to prescriptive exercise. To the investigator's~     knowledge, no studies have examined the impact on pain and function after multiple sessions~     of self directed exercise in this patient population.~      This study hoes to be a case series exploring the effects of self directed exercise on~     participants with fibromyalgia. Participants will be encouraged to exercise 8-12 times in a 4~     week time frame at a self selected pace and intensity on a stationary bicycle. Outcome~     measures such as the Fibromyalgia Impact Questionnaire, SF-36 and Numeric Pain Rating Scale~     will be used prior to study participation as well as 4 and 8 weeks following the start of~     participation.~   "
12706|NCT03400514|"~     At present, Watson for Oncology has been applied in 14 countries worldwide, including China,~     the United States, Holland, Thailand, India, Korea, Poland, Slovakia and Bangladesh. In a~     double-blind study involving 362 patients in India, treatment recommendations from Watson for~     Oncology (WFO) performed a high degree of consistency with their multidisciplinary tumor~     board. The investigators would recruit cancer patients diagnosed as lung cancer, breast~     cancer, gastric cancer, colon cancer， rectal cancer，cervical cancer or ovarian cancer~     according to the criteria of Watson for Oncology ，using the updated version of Watson for~     Oncology to explore the concordance of therapeutic regimen between WFO and physicians in the~     Affiliated Hospital of Qingdao University.~   "
12707|NCT03400501|"~     This is a pilot study to examine and compare the efficacy of supervised injections of long~     acting insulins degludec and glargine to protect youth with poorly controlled type 1 diabetes~     (T1D) from development of ketones.~   "
12710|NCT03400462|"~     The aim of this study was to compare the effectiveness of myofascial pain treatment methods.~   "
12713|NCT03400423|"~     The effects of moderate intensity aerobic exercise and caffeine ingestion on cognition (more~     specifically working memory) in non-caffeine drinker and caffeine drinkers will be examined.~     The non-caffeine drinkers will be recruited for two visits, whereas, the caffeine drinkers~     will be recruited for three visits. The study involves a baseline assessment of cognition and~     examines the effects of exercise and caffeine. Finally the caffeine group will consist of a~     baseline and intervention assessment when deprived of caffeine (overnight abstinence). The~     exercise intervention is to complete 20-minutes of moderate intensity exercise (brisk walk)~     while the caffeine condition is to consume 1.2 mg/kg of caffeine. Immediately following both~     intervention the n-back assessment will be conducted.~   "
12714|NCT03400410|"~     Prospective randomized control trial of an educational electronic application on female~     hormonal contraception for adolescent males in the pediatric emergency department.~   "
12715|NCT03400397|"~     The aim of the present study is to investigate the effectiveness of the Cool Kids programme~     after implementation in two outpatient psychiatric clinics for children in Southern Jutland,~     Denmark. The Cool Kids programme is a manualised cognitive behavioural treatment programme~     for children aged 6 to 12 years with anxiety disorders. Previous efficacy studies have found~     that 60-80% of all children who complete the program show marked improvement. However, only~     one previous effectiveness study has ever been conducted. It is therefore relevant to examine~     whether the previously mentioned effect is maintained when the programme is implemented in a~     healthcare setting rather than a research setting.~   "
12716|NCT03400384|"~     To assess the effectiveness of a government-led population-based opioid intervention on~     discontinuation of opioid medication in community-dwelling adults with chronic non-cancer~     pain.~   "
12717|NCT03400371|"~     The investigators are collecting genetic information through blood samples as well as~     clinical and EEG data from over 1000 people with Juvenile Myoclonic Epilepsy (JME) across the~     UK, Europe and North America. This study will draw on both existing and new samples from JME~     patients. These will be compared to anonymised data from samples for 2000 controls. The goal~     of this study is to find the genetic cause of JME. Finding the cause will help create better~     treatments for JME, as well as improve patient outcomes by allowing us to detect it earlier.~   "
12718|NCT03400358|"~     To evaluate the uterocervical angle (UCA) in the prediction of second trimester termination~     success of multiparous women.~   "
12719|NCT03400345|"~     Upper extremity allotransplantation is a new procedure which is becoming more common in the~     United States. Ongoing data collection for research purposes is vital to the long-term~     assessment as to the safety of the procedure and accompanying immunosuppression protocol, as~     well as quantifying patient outcomes and changes in quality of life. For these reasons, The~     Johns Hopkins Hand/Arm Transplantation Team is interested in enrolling transplanted patients~     in a follow-up protocol to continue collecting informative data to further the field of~     vascularized composite allotransplantation.~   "
12720|NCT03400332|"~     The purpose of this study is to investigate experimental medication BMS-986253 in combination~     with Nivolumab in patients with advanced cancers.~   "
12721|NCT03400319|"~     The objective of this prospective cohort study is to determine the prevalence of obstructive~     sleep apnoea (OSA) in patients with and without thoracic aortic aneurysm.~   "
12722|NCT03400306|"~     This study will evaluate the bioavailability between the veliparib tablet formulation to the~     capsule formulation; and will assess the effect of food on veliparib bioavailability in~     participants with ovarian cancer.~   "
12723|NCT03400293|"~     This study is designed to identify the burden associated with HIV and its treatment, and~     assess their health-related quality of life (HRQoL) by measuring key HRQoL domains, including~     satisfaction with treatment and care, and internalised stigma (ISAT). The study will also~     explore data for various important subpopulations such as subjects who are virally~     suppressed; who we anticipate will be the majority of study subjects. The study design is an~     observational, cross sectional study employing subjects' own mobile phone devices for data~     entry.~   "
12724|NCT03400280|"~     This Nationwide stepped-wedge cluster randomized trial is designed to evaluate if the~     implementation of a best practice algorithm for postoperative care results in a decrease in~     incidence of major complications and death after pancreatic resection as compared to current~     practice.~   "
12725|NCT03400267|"~     Fast and accurate platelet inhibition is an important therapeutic goal in the acute treatment~     of patients with ST-segment elevation myocardial infarction (STEMI). Platelet inhibitory~     effects induced by normal oral P2Y12 receptor antagonists, for example ticagrelor, are~     delayed in STEMI patients undergoing primary percutaneous coronary intervention (primary~     PCI), which may be attributed to impaired absorption affecting drug pharmacokinetics (PK) and~     pharmacodynamics (PD). Another therapeutic goal in the acute treatment of STEMI is reduction~     of sympathetic stress and catecholamine release, thereby improving the balance between the~     demand for and supply of oxygen, by analgesia like fentanyl of morphine. To date, there are~     no studies that have specifically assessed the pharmacodynamics influences of fentanyl on~     platelet inhibition in STEMI patients who are pre-treated with crushed ticagrelor tablets.~     Therefore, In the ON-TIME-3 study, the investigators seek to show the influence of fentanyl~     on platelet inhibition in STEMI patients who are pre-treated with crushed ticagrelor in the~     ambulance.~   "
12726|NCT03400254|"~     The specific purposes of this study are to: 1) Determine the best dose of gedatolisib (GED)~     to give in combination with hydroxychloroquine (HCQ, at a fixed dose) to people with~     disseminated tumor cells detected in their pone marrow. 2)Determine how well these drugs do~     at reducing the number of disseminated tumor cells in the bone marrow. 3) Determine the type~     and degree of side effects of these drugs in people who have completed treatment for breast~     cancer.~   "
12727|NCT03400241|"~     Absorption of inhaled tiotropium is compared between three Tiotropium Easyhaler products and~     Spiriva capsules inhaled via HandiHaler. All subjects will receive all products as a single~     dose.~   "
12796|NCT03399344|"~     The only chance of cure for patients with advanced stage ovarian cancer is complete~     cytoreductive surgery (CRS). The only way to determine whether complete CRS can be achieved~     is by a laparoscopy. However, diffusion-weighted magnetic resonance imaging (DW-MRI) has a~     very high sensitivity to detect small volume malignant disease, making it a potentially~     suitable staging tool. Aim of this study is to determine the performance of DW-MRI for~     predicting whether complete CRS can be achieved.~   "
12728|NCT03400228|"~     Recent studies have demonstrated that the balance of intestinal microbiota is affected in~     chronic kidney disease (CKD), leading to a condition known as intestinal dysbiosis. These~     changes were associated with metabolic complications, accumulation of uremic toxins,~     inflammation, progression of CKD and cardiovascular risk. Measures with the aim of restore~     the balance of intestinal flora are suggested, such as the intake of probiotics composed of~     beneficial bacteria, but few studies have discussed the effect of these supplements in CKD.~     The present study aims to evaluate the effect of consumption of probiotics in factors~     associates with progression of CKD and cardiovascular risk. To such will be conducted a~     double-blind, placebo-controlled, and randomized clinical trial with 30 patients with CKD in~     stages 3-5, treated in ambulatories of Nephrology of the Hospital de Clínicas de Porto~     Alegre, independently of etiology and with steady renal function. Patients will be excluded~     whether in substitutive renal therapy, kidney transplant, on antimicrobial therapy or~     immunosuppressive agents in the last three months or with acute clinical events. The~     assessment will include clinical and nutritional parameters, estimated glomerular filtration~     rate, proteinuria, serum lipids, inflammatory factors, and bowel habits. The study protocol~     includes the recruitment of patients who will undergo to 4-week washout period. After~     patients will be randomized and provided with probiotic therapy (intervention group) or~     placebo (maltodextrin; control group) for 24 weeks. All patients will be instructed to~     consume 2 sachets/day of probiotic or placebo and receive nutritional advice. All data will~     be analysed by the principal investigator with the support of a trained statistician and the~     chief investigator. The statistical programme SPSS will be used.~   "
12729|NCT03400215|"~     The role of fat in breast cancer development and growth has been studied extensively using~     body mass index, a measure of whole body fatness, and dietary fat intake in a number of~     epidemiological studies. However, there is a paucity of studies, on an individual level, to~     assess the role of breast fat itself in breast cancer due to lack of a non-invasive and fast~     measurement method. Since breast fibroglandular cells are surrounded by breast fat cells, the~     characteristics of breast fat may have a stronger relationship with breast cancer~     development, as supported by recent studies showing that a majority of breast cancer develops~     at the interface between fibroglandular tissue and adipose tissue. However, it is not trivial~     to study the role of breast fat, mainly due to the lack of a non-invasive and fast~     measurement method sensitive enough to important features of breast fat, such as types of~     fat.Recently, we have developed a rapid MRI method, referred to as Gradient-echo~     Spectroscopic Imaging (GSI), to measure fatty acid composition during clinical breast MRI~     exams. GSI can provide map of saturated fat and unsaturated fats in the breast adipose tissue~     without performing tissue biopsy. Our pilot study found that the postmenopausal women with~     aggressive breast cancer, known as invasive ductal carcinoma, have a significantly higher~     percentage of saturated fat in their breast adipose tissue than the postmenopausal women with~     only benign lesions.~   "
12730|NCT03400202|"~     This study will evaluate the physiopathologic characteristics of dark circles in participants~     with various ethnicities and Fitzpatrick Skin Types and the impact of the dark circles on the~     quality of life.~   "
12731|NCT03400189|"~     This preliminary pilot exploration aims at specifying the pharmacokinetic parameters of~     sulthiame, formulated as an immediate release tablet, thus helping to design proper clinical~     trials for the future assessment of new paediatric formulations currently under development.~     The clinical tolerability to single doses of sulthiame will also be closely monitored to~     orient future trials.~   "
12732|NCT03400176|"~     Patients enrolled to the study will have chronic lymphocytic leukemia (CLL) and are actively~     receiving ibrutinib. Patients will have either been receiving ibrutinib for one year without~     having had a complete response or patients will have developed a resistance mutation to~     ibrutinib. This study will have two parts, a dose escalation part and a dose expansion part.~     In the dose escalation part, the maximum tolerated dose (MTD) of the combination of VAY736~     with ibrutinib will be determined. Once determined, the dose expansion part of the study will~     begin.~   "
12733|NCT03400163|"~     The purpose of this sub-study of MB130-045 is to determine the pharmacokinetic effects,~     pharmacodynamic effects, efficacy and safety of BMS-986036 20 mg QD in subjects with~     Non-alcoholic Steatohepatitis (NASH)~   "
12734|NCT03400150|"~     The ProSpace™ System is intended to temporarily position the anterior rectal wall away from~     the prostate during radiotherapy for prostate cancer and in creating this space it is the~     intent of the ProSpace System to reduce the radiation dose delivered to the anterior rectum.~     ProSpace is a balloon composed of a biodegradable material that maintains that space for the~     entire course of prostate radiotherapy treatment and is completely absorbed by the patient's~     body over time.~   "
12735|NCT03400137|"~     The purpose of this study is to improve understanding of the pathophysiologic process that~     leads to the development of glaucamotous damage. The mechanism by which vision loss in~     glaucoma occurs is still unknown, but it is clear that increased intraocular pressure (IOP)~     is a major risk factor. It is also thought that the LC is a site of primary damage during~     pathogenesis of the disease. This prospective study with determine the in-vivo mechanical~     response to IOP modulation at the level of the ONH and LC.~   "
12736|NCT03400124|"~     The purpose of this study is to evaluate the effectiveness and costs of immediately~     sequential bilateral cataract surgery (ISBCS) compared to delayed sequential bilateral~     cataract surgery (DSBCS) in order to determine whether ISBCS is an effective and~     cost-effective alternative to DSBCS.~   "
12737|NCT03400111|"~     Patients with class I malocclusion who have mild to moderate crowding will be treated in this~     study. The efficacy of low level laser therapy and Panadol-extra® in relieving pain due to~     orthodontic treatment will be assessed. The effect of these two interventions on oral-health~     related quality of life during all stages of orthodontic treatment will be explored, i.e. at~     the following stages: (1) separation between teeth, (2) archwire changing, (3) bonding of~     brackets, (4) removal of the fixed appliances.~      There are three groups :~        1. a group of patient being irradiated with low-level laser therapy (LLLT) at specific time~          points to relieve pain and discomfort.~        2. a group of patient in which pain control will be accomplished by prescribing Panadol~          Extra tablets in a regular manner.~        3. a group of patients in which nothing will be given to them during the course of~          treatment.~   "
12738|NCT03400098|"~     The purpose of this program is to provide expanded access to Inotersen for up to 100 Patients~     with Hereditary Transthyretin Amyloidosis (hTTR).~   "
12739|NCT03400085|"~     The investigators are interested in whether or not the use of a mobile health (mHealth)~     application increases the rate of follow-up compliance among living kidney donors. The~     investigators aim to test this by randomly assigning living kidney donors to the intervention~     (use of mHealth application to complete required living kidney donor follow-up at 6 months, 1~     year, and 2 years) or control arm (standard of care) upon discharge from their initial~     donation hospitalization, and tracking follow-up compliance over time. The study population~     will be approximately 400 living kidney donors who undergo donor nephrectomy at Methodist~     Specialty and Transplant Hospital (200/year for 2 years).~   "
12740|NCT03400072|"~     Exercise during chemotherapy (CT) is a promising strategy to reduce fatigue and improve~     health-related quality of life (HRQoL). Exercise may also have beneficial effects on tumor~     outcome by decreasing insulin resistance, inflammation, and by modulating various pro-tumoral~     signalling pathways. It has been shown to reduce mortality in breast and colorectal cancer~     adjuvant setting.~      This study aims to explore the effects of adapted physical activity (APA) in patients with~     resected pancreatic ductal adenocarcinoma (PDAC).~   "
12741|NCT03400059|"~     The efficacy of intranasal kinetic oscillation stimulation using the Chordate System S211 as~     a preventative treatment will be examined in patients diagnosed with chronic migraine. The~     medical device system will be applied in 6 treatments at weekly intervals. The study will~     examine the effects on monthly headache days with moderate to severe intensity.~   "
12742|NCT03400046|"~     Patients who are suffer from CIF often develop muscle wasting because of hypercatabolism.The~     relationship between different nutrition support formulas and lean body mass is still~     unclear. The purpose of this study is to investigate the relationship between nutrition~     support and muscle mass and attempt to find the nutrients which will benefit lean body mass~     in patients with CIF.~   "
12743|NCT03400033|"~     This Phase 3 study in hemodialysis-dependent subjects with anemia will evaluate the efficacy~     and safety of daprodustat administered three-times weekly compared to epoetin alfa, the~     current standard of care. This study includes a 4 week Screening Period, a 52 week Treatment~     Period and a 4 to 6 week follow-up period. Each subject will remain in the study for up to 62~     weeks. Approximately 402 subjects will be randomized to receive either daprodustat three~     times weekly or epoetin alfa three-times weekly or once weekly, depending on dose level.~   "
12744|NCT03400020|"~     Postpolypectomy bleeding is the most common major complication following a colonoscopic~     polypectomy procedure. The incidence rate ranging from 0.3 to 6.1%. Several preventive~     methods such as detachable snare and adrenaline injection have been proposed in the~     management of postpolypectomy bleeding in large colonic polyps. It has been demonstrated that~     administration of ascorbic acid (vitamin C) in abdominal surgeries could reduce the blood~     loss during the procedure, operation time and days of hospitalization. So the investigators~     designed a prospective, randomized study to compares the efficacy of vitamin C administration~     with application of prophylactic clip and detachable snare in the prevention of~     postpolypectomy bleeding in large polyps.~   "
12745|NCT03400007|"~     Pelvic organ prolapsed, associated with defecation disorders and urinary tracts symptoms are~     common and affect up to 25% of the population, mostly parous women. The pelvic floor must be~     seen as one entity, with multiple anatomical and physiological interactions between the~     various compartments (rectum, vagina, uterus and bladder) which are embedded in the same~     anatomical region. The often complex pathologies of this region should therefore be treated~     in a multidisciplinary setting.~      Besides clinical evaluation, functional dynamic imaging of anorectal and pelvic floor~     disfunctions has an important role in the diagnosis and management of these disorders.~     Although the colpocystodefecography is still considered to be the golden standard in imaging~     this complex anatomical region, there is clearly a need for more precise imaging of the~     structural details, preferentially without any irradiation. Transperineal ultrasound is an~     option but the investigators have chosen to evaluate the use of dynamic magnetic resonance~     imaging. In contrast to colpocystodefecography, dynamic pelvic floor magnetic resonance~     imaging is an evolving technology and its precise role in functional imaging of the pelvic~     floor still remains to be determined.~      Prolapse surgery is commonly performed and therefore it is important to assess the efficacy~     of the operations in correcting the anatomical defects and the symptoms associated without~     creating new, pelvic floor related symptoms. Few studies exist today allowing the assessment~     of the anatomical changes and symptoms after surgery, through abdominal or perineal approach.~      This study will evaluate the reliability of the dynamic pelvic floor imaging, done in a~     sitting position, compared to colpocystodefecography, done in a sitting position. It will~     also compare clinical objective and subjective results related to pelvic floor abnormalities~     with imaging. Finally, it will evaluate the anatomical changes in correlation with the~     clinical results, organ position and inter-compartments relationships after surgery.~      This study will allow to understand and explain some relapses and failures and could lead to~     an improvement of the indications for surgery and surgical techniques used.~   "
12746|NCT03399994|"~     The objective of the study is to compare angiographic and clinical performance of Abluminus~     DES+ versus Everolimus-eluting DES in patients with diabetes mellitus.~   "
12747|NCT03399981|"~     The primary purpose of this study is to estimate the incidence of progressive multifocal~     leucoencephalopathy (PML) among patients who switched to Tysabri from disease modifying~     therapies (DMTs), including newer DMTs (including fingolimod, dimethyl fumarate and~     teriflunomide) and the established DMTs (interferon beta and glatiramer acetate). Researchers~     will also look to estimate the incidence of other serious opportunistic infections among~     patients who switch to Tysabri from newer DMTs (including fingolimod, dimethyl fumarate and~     teriflunomide) and the established DMTs (interferon beta and glatiramer acetate)~   "
12748|NCT03399968|"~     The global prevalence of spinal cord injury is estimated between 236 to 4187/Million. A~     spontaneous recovery of the sense-motoric function is decreasing with the time after injury~     and is only seen sporadically after 1 to 2 years. Treatment options are mainly limited to~     improvement of the quality of life.~      The present prospective randomized study is intended as a double-blind, placebo controlled~     multi-center investigation. Patients suffering from chronic paraplegia (lesion between THII~     and THX, ASIA A = complete central lesion) at least for 1 year after the initial trauma~     without spontaneous remission of the last 6 months are considered to be included in the~     study. Meeting the inclusion criteria and signing the informed consent, patients are treated~     in one of the two study centers. At study inclusion, a baseline evaluation comprising~     neurological, neurophysiological, functional and clinical investigation is performed.~     Patients dedicated to the ESWT intervention group will be treated once a week over 6 weeks~     with local non-invasive low energy extracorporeal shockwave therapy (=6 treatments with an~     electrohydraulic device). The follow-up will include neurological, neurophysiological,~     clinical as well as functional evaluation at the time points 6 weeks, 3 months and 6 months.~     Additionally, patients will be provided with a diary for documentation of drug adaptation,~     grade of spasticity and pain. Those patients dedicated to the Placebo ESWT group, will~     receive the identical scheme in treatment (but without application of shockwaves) and~     follow-up as the patients in the ESWT group. However, after positive completion of the study,~     these patients will be offered ESWT as well.~   "
12750|NCT03399942|"~     Deep brain stimulation (DBS) of the sensory thalamus has been proposed for 40 years to treat~     medically refractory neuropathic pain, but its efficacy remains partial and unpredictable.~     Recently, bilateral DBS of the dorsal anterior cingulate cortex (ACC), a brain region~     involved in the integration of the affective and cognitive aspects of pain, has been~     successively proposed to treat few patients suffering from refractory chronic pain, by~     decreasing the emotional impact of their chronic pain. ACC-DBS could be an alternative or~     complementary approach to thalamic DBS in these patients, but the consequences of chronic~     dACC-DBS on cognition and affects have not been studied specifically.~      The primary objective is to evaluate the feasibility and safety of bilateral ACC-DBS combined~     with unilateral thalamic DBS in patients suffering from chronic unilateral pain, refractory~     to medical treatment. Secondary objective will evaluate the efficacy of this combined DBS~     compared to thalamic DBS only.~   "
12751|NCT03399929|"~     Investigators will determine the long-lasting effects of post-acute rehabilitation after~     traumatic brain injury and stroke. Investigators will also evaluate if the beneficial effects~     of rehabilitation continue after discharge from a rehabilitative program.~   "
12752|NCT03399916|"~     A two phase trial to understand the personal, behavioral, environmental, and contextual~     factors that underpin sedentary behavior and to systematically test a series of contextual~     prompt characteristics that may lead to subsequent change in sedentary behavior.~   "
12753|NCT03399903|"~     An open label study will be performed on 60 people with HIV infection who are maintained on~     effective treatment with antiretroviral drugs.~   "
12754|NCT03399890|"~     Neurological physical exam is a very important outcome that should be evaluated as soon as~     possible after every lumbar procedures. The aim of this study was to evaluate the~     neurological physical examination time after lumbar procedures.~   "
12755|NCT03399877|"~     Uroflowmetry(UF) has been the standard first-line diagnostic tool for the evaluation of~     pediatric voiding dysfunction. But recently, UF combined with pelvic flow~     electromyography(EMG) is emphasized and recommended to analyze the separate contributions of~     the detrusor and bladder outlet and sole UF is discouraged except for the follow-up study~     after abnormal UF/EMG result(Bauer et al., 2015). However, electrode itself can disturb~     pelvic floor relaxation and there is no evidence about necessity of consecutive UF/EMG test.~     Therefore, we are going to compare three different methods (Primary-Secondary: UF/EMG-UF/EMG,~     UF/EMG-sole UF, sole UF-UF/EMG)~   "
12756|NCT03399864|"~     This study aims to work out the effectiveness (effect size) of the musical training~     intervention in reducing depressive symptoms, improving self-esteem and quality of life among~     childhood brain tumour survivors and to examine the feasibility, appropriateness, and~     acceptability of implementing musical training intervention in clinical practice. Subjects in~     the experimental group will receive weekly 45-minute lessons on musical training for one year~     (52 weeks), while those in the control group will receive usual care.~   "
12757|NCT03399851|"~     Left atrial appendage closure (LAAC) is an emerging therapeutic option in non-valvular atrial~     fibrillation (NVAF) patients with high thromboembolic and bleeding risks. In Europe the~     devices most frequently utilized for LAAC are Amplatzer Amulet (St. Jude Medical-Abbott) and~     Watchman (Boston Scientific) system. However there are currently no randomized controlled~     trials assessing the degree of LAA closure between the two devices. The main purpose of this~     trial is to evaluate the feasibility and the efficacy of the devices in terms of LAA complete~     occlusion with a non-invasive imaging technique such as cardiac computed tomography~     angiography (CCTA).~   "
12758|NCT03399838|"~     Anxiety in children needs to be addressed to reduce stress, to be able to perform procedures~     where a child needs to lie still, and to prevent anxiety in the future. Intranasal~     dexmedetomidine has proven to be a very reliable and safe medication in a variety of~     pediatric settings. But, data for the use of dex at the PED are sparse.~      The investigators intend to determine if dexmedetomidine is clinically superior to midazolam~     (standard of care), defined by 20% superiority in anxiety relief, and non-inferiority in~     satisfaction of sedation providers as well as patients and parents. Additional data will be~     collected. Patients aged 6 months and older will be included when midazolam sedation is be~     intended, with main focus on the age group up of those up to 6 years (140 patients in this~     age group). Random assignment will compare dexmedetomidine with midazolam.~   "
12759|NCT03399825|"~     Comparison of OCTA to conventional imaging modalities for the diagnosis of eye diseases in~     children~   "
12760|NCT03399812|"~     This study will determine the short-term postprandial effects of protein source at breakfast~     on energy metabolism, markers of metabolic health, appetite, and food intake and young and~     older men.~   "
12761|NCT03399799|"~     The purpose of this study is to characterize the safety of JNJ-64407564 and to determine the~     recommended Phase 2 dose(s) (RP2Ds) and dosing schedule assessed to be safe for JNJ-64407564.~   "
12762|NCT03399786|"~     The primary objective of the study is to demonstrate the reduction of low-density lipoprotein~     cholesterol (LDL-C) by evinacumab intravenously (IV) in comparison to placebo after 24 weeks~     in patients with homozygous familial hypercholesterolemia (HoFH). The secondary objectives of~     the study are to evaluate the effect of evinacumab IV on other lipid parameters, evaluate the~     effect of evinacumab on LDL-C goal attainment, assess the effect of evinacumab on eligibility~     for apheresis (using German and US apheresis criteria), evaluate the safety and tolerability~     of evinacumab in patients with HoFH, assess the pharmacokinetics (PK) of evinacumab in~     patients with HoFH and evaluate the potential development of anti-evinacumab antibodies.~   "
12763|NCT03399773|"~     This phase II trial studies how well donor umbilical cord blood transplant with ex-vivo~     expanded cord blood progenitor cells (NLA101) works in treating patients with blood cancer.~     Before the transplant, patients will receive chemotherapy (fludarabine, cyclophosphamide and~     in some cases thiotepa) and radiation therapy. Giving chemotherapy and total-body irradiation~     before a donor umbilical cord blood transplant helps stop the growth of cells in the bone~     marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop~     the patient's immune system from rejecting the donor's stem cells. When the healthy stem~     cells from a donor are infused into the patient they may help the patient's bone marrow make~     stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may~     also replace the patient's immune cells and help destroy any remaining cancer cells.~   "
12764|NCT03399760|"~     Twenty patients need therapeutic extraction of the maxillary first premolars with subsequent~     retraction of the maxillary canines, will be divided randomly into two groups, and will~     randomly assigned to one side of the maxillary arch at the first premolar region, and the~     other side served as the control. Canine retraction will be initiated after completion of the~     leveling and alignment phase via closed nickel-titanium coil springs applying 150 g of force~     per side. Soldered transpalatal arch will be used as an anchor unit. The dento-alveolar~     changes will be assessed immediately before retraction and after 6 months using CBCT.~   "
12765|NCT03399747|"~     Phase 2 Study of Abbreviated 3 Cycles of Rituximab plus CHOP (Cyclophosphamide, Adriamycin,~     Vincristine, and Prednisolone) Immunochemotherapy in Patients with Completely Excised~     Localized Gastrointestinal CD20 (+) Diffuse Large B-cell Lymphoma(SATURDAY STUDY)~   "
12766|NCT03399734|"~     This study will be conducted to demonstrate the bioequivalence between a single 4 milligram~     (mg) dose of fine granules of perampanel and a single 4 mg tablet of perampanel.~   "
12767|NCT03399721|"~     This is an interventional, multicenter, double-blind, placebo-controlled trial in which~     patients diagnosed with non-allergic rhinitis will be randomized to either intranasal~     stimulation, or placebo treatment with the Chordate System at two occasions.~   "
12768|NCT03399708|"~     To use apremilast in clinical practice as a molecular probe to evaluate the effects of PDE4~     inhibition on the cardiometabolic status and immune profile in patients with PsA and~     psoriasis.~   "
12769|NCT03399695|"~     High flow nasal cannula oxygen has been proposed to perform preoxygenation in patients with~     acute respiratory failure requiring orotracheal intubation in intensive care units. However,~     its use for preoxygenation before the induction of general anaesthesia in operating room has~     never been evaluated in term of end tidal oxygen fraction which is the gold standard~     measurement during preoxygenation before general anaesthesia.~      The goal of the present study is to measure end tidal oxygen after 3 min of preoxygenation~     using the recommended method (spontaneous breathing of 100% inhaled oxygen through a face~     mask) and using high flow nasal canula oxygen, in healthy volunteers.~   "
12770|NCT03399682|"~     Cystography is a frequent pediatric examination, although indications have been recently~     restricted .~      Current indications in our center are:~        -  The occurrence of 2 episodes of acute pyelonephritis~        -  or 1 episode of pyelonephritis if dilatation of the pelvic ureter> 5 mm for male~          children Urinary tract infections that occurred in the month following this test are~          considered secondary to cystography.~      However, no recent study has investigated the prevalence of urinary tract infections post~     cystography.~      There is no recent epidemiological data on this risk of infection, especially since the~     management of infections has changed and aseptic precautions during retrograde cystography~     have evolved with most of the time coverage. antibiotic.~      The main objective of this multi-center epidemiological prospective study is to perform a~     recent analysis of the retrograde post-cystographic urinary tract infection rate.~      Material and methods:~      Epidemiological, observational, multicenter, prospective study over a period from January~     2018 to January 2019. No therapeutic modification will be undertaken at the end of the study.~      Parents will be called one months after the exam to check if their child had a urinary~     infection.~   "
12771|NCT03399669|"~     Although EGFR-TKIs such as gefitinib, erlotinib or afatinib are recommended as first-line~     therapy in patients with advanced, recurrent or metastatic nonsquamous NSCLC patients who~     have known active EGFR mutation and achieved response to EGFR TKIs experience disease~     progression eventually with 10-14 moths of median progression free survival.6~     Platinum-doublets combination chemotherapy remains standard of care for patients with~     progressive disease. However, patients may derive benefit from EGFR TKIs after~     RECIST-assessed progression especially for those who experience slow progression. And~     previous report suggested that premature discontinuation of EGFR TKIs has resulted in rapid~     progression in symptoms and tumor growth.7 Recently, a prospective phase II single arm study~     in Asian patients with EGFR mutation-positive NSCLC to determine the continuation of~     erlotinib beyond progression judged by investigators showed that additional PFS of 3.1 months~     can be achieved with continuation of erlotinib without serious additional toxicities.8 Until~     now, no prospective study has been conducted for gefitinib.~      In this study the continuation of gefitinib beyond RECIST progression will be investigated to~     determine the clinical outcomes including the duration of treatment and safety.~      This is a single-arm phase II trial to evaluate the efficacy and safety of continuation of~     gefitinib in EGFR mutant NSCLC patients who experience RECIST progression. Based on the~     results of ASPIRATION study, the median PFS for continuation of gefitinib will be around 3~     months. The study treatment will be of no interest if the true median PFS is 2.5 months or~     shorter. In contrast, it will be of interest if the true median PFS is 3.5 months or longer.~     Considering 1 sided alpha of 0.05 and 90% of power, 95 patients are required. A total of 100~     patients will be needed considering 5% of drop-out rate. 6 months of accrual and additional 6~     months of follow-up will be assumed for this study.~      Patients will be treated 250 mg/day of gefitinib orally (1 cycle for 28 days). Cycles were~     repeated until disease progression, unacceptable toxicity, or until the patient or the~     investigator requested therapy discontinuation.~   "
12772|NCT03399656|"~     Do daily high (4 tablets) or intermediate (2 tablets) administration of the broccoli-based~     dietary supplement Avmacol® have improved bioavailability over a broccoli sprout beverage~     rich in sulforaphane and its biogenic precursor, glucoraphanin? The beverage formulation has~     been used successfully in the investigators' previous intervention studies in regions of~     China with high levels of air pollution to reduce the body burden of carcinogenic and toxic~     pollutants. The investigators seek to evaluate a more stable, less expensive formulation of a~     broccoli sprout preparation that can be used for disease prevention in future studies.~   "
12773|NCT03399643|"~     The objective of this study is to investigate the effectiveness of Atezolizumab with a~     primary focus on the overall survival (OS) rate at 2 years and secondary focuses on quality~     of life (QoL) and the sequence of treatment in mUC patients. Furthermore, this study aims at~     collecting data on safety of Atezolizumab and on the reason for cisplatin-ineligibility~   "
12774|NCT03399630|"~     Evaluating the safety and efficacy of a single injection of autologous adipose tissue for~     treatment of osteoarthritis of the knee.~   "
12775|NCT03399617|"~     The primary goal of the study is to prevent undernutrition and obesity in children under two~     years old in rural areas of Guatemala. This study is designed to evaluate whether the~     proposed treatment reduces the prevalence of overweight, underweight and low height-for-age~     indicators in the rural environment of Baja Verapaz. This study design has been developed in~     conjunction with colleagues from Fundazúcar, a local foundation in Guatemala.~   "
12776|NCT03399604|"~     The primary objective of this study is to evaluate the long-term safety and tolerability of~     LIQ861, a dry powder formulation of treprostinil, in patients with Pulmonary Arterial~     Hypertension (PAH). A secondary objective of this study is to evaluate the comparative~     bioavailability of treprostinil between two formulations of inhaled therapy.~   "
46699|NCT02955615|"~     The purpose of this study is to evaluate the efficacy and safety of ILT-101 (human~     recombinant interleukin 2 (IL-2)) in patients with moderate to severe systemic lupus~     erythematosus.~   "
12777|NCT03399591|"~     The prevalence of neurodegenerative diseases will increase over the next decades driven by~     ageing population. It seems important to develop reliable, replicable and accessible~     diagnostic tools.~      This is a prospective study whose objective is to study the spatio-temporal parameters of~     gait in patients with Alzheimer's and Lewy body diseases. 64 patients were included in this~     study. A comparison of the two pathologies was conducted, followed by an analysis based on~     four groups (mild, severe Alzheimer's disease, mild, severe Lewy body disease) and a study of~     the severity of the diseases. To study these parameters, we used the Gaitrite treadmill.~      The analysis of spatio-temporal parameters of walking in Alzheimer's disease and Lewy body~     disease enables to identify discriminating variables between the two pathologies. The~     probability of suffering from an Alzheimer's disease decreases with the pace increase but~     increases with variations in length of the step, and with the rotation of the foot. While the~     probability of suffering from Lewy body disease increases with the pace, variations in the~     step duration, and the duration of double support.~      These results are interesting but do not allow to establish a diagnostic score for these two~     diseases. The monitoring of the variations of these parameters at individual level would~     probably be more relevant and would enable to detect dual pathologies.~   "
12778|NCT03399578|"~     This is a clinical trial in which healthy volunteers will be administered an experimental~     MERS vaccine. The vaccine ChAdOx1 MERS will be administered alone as a single administration.~   "
12779|NCT03399565|"~     This study aims to understand and evaluate different age children and adolescents with~     diabetes prevalence, self-management of disease , for diabetes patients and their families to~     provide diabetes management information, so as to help the children and adolescents diabetes~     patients to improve the quality of life.~   "
12780|NCT03399552|"~     The purpose of this study is to find out whether the combination of avelumab and SBRT is safe~     and what effect avelumab has on mesothelioma when given in combination with SBRT. In~     addition, a goal of this protocol is to study the effect of radiation therapy on the immune~     system. It is thought that radiation treatment may create a form of 'vaccine' against cancer~     inside the body and immunotherapy may improve this effect. The combination of radiation~     treatment and immunotherapy may be more effective against cancer than either radiation or~     immunotherapy alone.~   "
12781|NCT03399539|"~     This phase I/II trial studies the side effects and best dose of venetoclax when given~     together with ixazomib citrate and dexamethasone and to see how well they work in treating~     patients with multiple myeloma that has come back. Venetoclax and ixazomib citrate may stop~     the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used~     in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Giving venetoclax together with ixazomib citrate and dexamethasone may work better~     in treating patients with multiple myeloma.~   "
12782|NCT03399526|"~     Evaluation of efficacy and safety of Mapracorat 0.1% ointment and 4 comparator ointments in~     male and female subjects 18 to 65 years with stable plaque-type psoriasis treated once daily~     6 days a week for a maximum of 4 weeks.~      Primary objective was to compare the efficacy of all test compounds by measurement of~     psoriatic infiltrate thickness (PIT) with 20 MHz B mode ultrasound.~      Secondary objectives were to assess safety of all test compounds by measurement of the~     atrophogenic potential on non-lesional skin with 20 MHz B mode ultrasound, to assess the~     efficacy of all test compounds by measurement of intensity of erythema measured by~     chromametry, to assess the efficacy of all test compounds by visual assessment of the skin in~     the test fields using a 5-point score, to assess the safety of all test compounds by visual~     assessments of formation of teleangiectasia using a 5-point score, to assess the safety of~     all test compounds by visual assessment of atrophy using a 5-point score, to assess the~     safety of all test compounds by visual assessment of local tolerability using a 5-point~     score, to visualize the therapeutic index given by PIT versus non lesional skin thickness.~   "
12783|NCT03399513|"~     This study will investigate if treatment results obtained with R-CHOEP in young high-risk~     patients with diffuse large B-cell lymphoma can be further improved by the addition of~     ibrutinib to this regimen.~   "
12784|NCT03399500|"~     There is a significant revolving door of incarceration among homeless adults, a population~     with substantial health disparities. Homeless adults who receive the professional~     coordination of individualized care (i.e., case management) during the period following their~     release from jail experience fewer mental health and substance use problems, are more likely~     to obtain stable housing, and are less likely to be re-incarcerated. The proposed study will~     use mobile technology to address these barriers and fill gaps in the understanding of the~     causes of the revolving door of homeless incarceration. This research represents a step~     toward integrated service connection and healthcare service provision for one of the most~     underserved, high need, and understudied populations in the United States. Smart phone apps~     that increase the use of available healthcare services and identify predictors of key~     outcomes (e.g., homelessness, re-arrest, medication compliance) could be used to reach hard~     to reach populations with histories of significant and persistent health disparities (e.g.,~     homeless adults).~   "
12785|NCT03399487|"~     Lung cancer is the most leading cause of cancer-related mortality worldwide. Most of the~     patients with lung cancer are advanced stage at the time of diagnosis.~      The two oncogenes that are important in lung cancer are epidermal growth factor receptor~     (EGFR) and K-ras, mutated in 10% and 15% of non-small cell lung cancer (NSCLC) patients.~     Large-scale DNA sequencing efforts have identified mutations in BRAF, PI3KCA and ERBB2 that~     together represent another 5% of NSCLC patients. The success of EGFR tyrosine kinase~     inhibitors (TKIs), such as gefitinib or erlotinib, and more recently ALK/MET TKI, crizotinib,~     highlights the need to develop more genetically matched therapies. Therefore, genetic~     classification of lung cancer has become increasingly important along with the advances with~     targeted therapies.~      ROS1 is a receptor tyrosine kinase with constitutive kinase activity. ROS1 was previously~     discovered in cell lines where ROS1 fused with other proteins to act as a driver oncogene. In~     2007, Rikova et al reported ROS1 fusion as driver mutations in NSCLC cell line (HCC78;~     SLC34A2-ROS1) and NSCLC patient (CD74-ROS1). Li et al also found about 1% of samples~     harboring CD74-ROS1 fusion in 202 resected lung adenocarcinomas from never smokers. The~     incidence was as high as 10% in East Asian population. Currently there are now at least 13~     ROS1 fusion variants involving 8 fusion partners (CD74-, SLC34A2-, FIG-, TPM3-, SDC4-,~     LRIG3-, ERZ-, KDERL2-) identified in ROS1 positive NSCLC.~      Interestingly, preclinical and clinical data have shown ROS1-positive tumors are sensitive to~     crizotinib, because of potentially high common amino acid residues in the kinase domain~     between ALK and ROS1, which explain why crizotinib can inhibit both ROS1 and ALK to similar~     extent. Preliminary report from a phase I clinical trial of crizotinib in the ROS1-positive~     NSCLC expansion cohort showed an overall response rate (ORR) of 57%. Given that crizotinib~     has made remarkable clinical outcomes in phase I trial of ALK-positive NSCLC patients,~     clinical development of ROS1 inhibitors, including crizotinib, should be accelerated to~     provide targeted therapies to ROS1-positive NSCLC patients.~   "
12786|NCT03399474|"~     Intravenous Regional Anesthesia (IVRA) was first used by August Bier in 1908. This technique~     is easy to administer, reliable and cost-effective for short surgical procedures of the~     extremities performed on an ambulatory basis with success rate of approximately 95% - 100% .~      Lidocaine becomes the local anesthetic of choice for Intravenous Regional Anesthesia (IVRA)~     because of the lack of cardiac toxicity and neurotoxicity. But, delayed onset of action, poor~     muscle relaxation and lack of postoperative analgesia are the major limitations of this~     technique. Accordingly, many additives have been tried to overcome this problem. Muscle~     relaxants, ketamine,ketorolac, clonidine and opioids are examples of these adjuvants, and~     their effects have been studied in detail.~      An ideal anesthetic agent for IVRA should have rapid analgesic effect to reduce tourniquet~     pain and its effects should last longer enough after deflating tourniquet. To achieve this,~     other drugs including narcotics, nonsteroidal anti-inflammatory drugs, ketorolac, clonidine,~     nitroglycerin (TNG), dexmedetomidine, magnesium, and neostigmine were used in combination~     with lidocaine in different studies. This study aims 1- To compare the anesthetic and~     analgesic efficacy of Dexmedetomidine and lidocaine versus lidocaine only during IVRA (Bier's~     block) and 2-To compare anesthetic and analgesic efficacy of different doses of~     dexmedetomidine when used as adjuvants to lidocaine during IVRA (Bier's block).~   "
12787|NCT03399461|"~     WAS is a rare primary immune deficiency disease caused by genetic mutation and is more common~     in males than females. The purpose of this study is to understand experiences of WAS subjects~     and caregivers to identify important concepts of interest that could be measured in future~     Phase IIIb trials. This is a qualitative cross-sectional study that will include a sample of~     approximately, 8 subjects with WAS and 13 caregivers of subjects with a diagnosis of WAS in~     the United States, United Kingdom and France. A 60 to 90 minute open-ended interview will be~     conducted over the telephone or video conference that will be audio-recorded for subsequent~     transcription. The aim of these interviews is to obtain subject and caregiver perspectives on~     the impact of WAS and its associated treatments on quality of life and experiences of living~     with WAS.~   "
12788|NCT03399448|"~     This is a first-in-human trial proposed to test HLA-A*0201 restricted NY-ESO-1 redirected T~     cells with edited endogenous T cell receptor and PD-1.~   "
12789|NCT03399435|"~     Neosaxitoxin is a new compound that is in clinical development as local anesthetic for~     surgical anesthesia and postoperative analgesia.~      The primary objective of this study is to evaluate the systemic and local safety and~     tolerability of ascending doses of neosaxitoxin alone and in combination with fixed doses of~     bupivacaine (with and without epinephrine), following brachial plexus blockade in healthy~     male subjects.~      Secondary objectives:~        -  Evaluate the pharmacodynamics (PD) of ascending doses of neosaxitoxin, alone and in~          combination with fixed doses of bupivacaine (with and without epinephrine), following~          brachial plexus blockade.~        -  Characterize the pharmacokinetics (PK) of neosaxitoxin and bupivacaine after brachial~          plexus blockade with neosaxitoxin alone or different drug combinations: neosaxitoxin and~          epinephrine, neosaxitoxin and bupivacaine, or neosaxitoxin and bupivacaine and~          epinephrine.~   "
12790|NCT03399422|"~     Twenty patients need therapeutic extraction of the maxillary first premolars with subsequent~     retraction of the maxillary canines, will be divided randomly into two groups, and will~     randomly assigned to one side of the maxillary arch at the first premolar region , and the~     other side served as the control. canine retraction will be initiated after completion of the~     leveling and alignment phase via closed nickel-titanium coil springs applying 150 g of force~     per side , soldered transpalatal arch will be used as an anchor unit.~      Pre- and post distalization dental casts will be evaluated to study rate of canine~     distalization, over a follow-up period until a Class I canine relationship will be achieved.~     The levels of Pain and discomfort will be monitored using a questionnaire with a VAS scale~     administered three times during the first day after prf injection.~   "
12791|NCT03399409|"~     This study aims to evaluate the efficacy of motivational interviewing (MI) on adherence to~     exercises and on levels of pain and incapacity in patients who engage in physiotherapy for~     low back pain. Sixty patients attending a 15-day program of physiotherapy for low back pain~     were allocated to experimental (EG) and control groups (CG). A regular treatment of~     physiotherapy with at-home exercises is offered to all participants. On day seven, MI is~     applied to the EG. The CG receives an anti-inflammatory information program.~   "
12792|NCT03399396|"~     The central goal of this study is to identify the optimal approach to implementing an~     evidence-based practice facilitation (PF) intervention for the uptake and completion of HPV~     vaccine among adolescents receiving care in the community, guided by implementation science~     theory.~      AIM 1: Determine the clinical effectiveness and cost-effectiveness of two modalities for~     delivering a multi-component PF intervention to increase HPV vaccination initiation and~     completion in community-based pediatric practices. The investigators will compare the~     traditional In-person Coaching PF modality to a lower-resource Web-Based Coaching PF~     modality. The primary patient outcome is HPV vaccination. The investigators will also examine~     and compare the sustainability of practice changes on vaccination rates and the effects over~     time for each intervention modality.~      AIM 2. Understand mechanisms of why the PF intervention may work better for some pediatric~     practices than others for HPV vaccination. The investigators will examine theory-based~     determinants at the organizational, provider, and patient levels that may mediate (explain)~     or moderate (change) the effects of the PF intervention on vaccination outcomes.~   "
12793|NCT03399383|"~     Adherence, concerns and satisfaction with information in German patients with adrenal~     insufficiency as well as the influence of a standardized education program will be assessed~     by a compared cross-sectional and longitudinal study.~   "
12794|NCT03399370|"~     This is a Phase III, placebo-controlled, double-blind, randomized study in participants with~     ASCVD and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to~     evaluate the efficacy, safety, and tolerability of subcutaneous (SC) inclisiran injection(s).~     The study will be a multicenter study in the United States.~   "
12795|NCT03399357|"~     The trial aims to evaluate role of metabolic factors including systemic 25-OH D and diabetes~     in the adaptive immune response (haemagluttination inhibition titer) to influenza vaccine in~     the elderly. The influenza vaccine administered in this study will be licensed trivalent~     inactivated influenza vaccine. Elderly who are age above 65 including those with~     co-morbidities such as diabetes mellitus will be included. The study has its inclusion and~     exclusion criteria to determine eligibility for participation.~   "
12797|NCT03399331|"~     Background: Oral mucositis (OM) is a significant complication occurring in approximately 40%~     of patients on chemotherapy regimens. Ulcerative lesions of OM can be very painful, with~     negative impact on diet, oral hygiene, and quality of life. Although a wide variety of agents~     have been tested to prevent OM or reduce its severity, none have provided conclusive~     evidence.~      Objectives of this study will be: to determine the efficacy of honey or olive oil on the~     severity and pain of OM compared to placebo (standard care) and, (2) to assess which of the~     two interventions is more beneficial.~      Research Questions:~        1. Children/adults who receive honey (group 1) or olive oil (group 2) will have less severe~          OM compared to the control group (Severity is measured by recovery time from OM and is~          the primary outcome)~        2. Children/adults who receive honey (group 1) OR Olive oil (group 2) will have less pain~          than the control group. (Severity of pain is the secondary outcome Methods: A randomized~          controlled study (RCT) will be used to evaluate the effect of topical application of~          honey or olive oil, in the treatment of chemotherapy-related OM in 60 participants with~          OM. The primary outcome will be the severity of mucositis, assessed by four trained~          nurses blinded to the study group using the scale presented by the World Health~          Organization (WHO). The secondary outcome will be pain also assessed by the four trained~          nurses on the visual analogue scale ort eh Wong Faces scale.~      The relevance of this study lies in the possibility of challenging nurses in regard to the~     problem of OM and in proving a possible herbal cure that may influence clinical practice.~      Data analysis: The characteristics of the three groups will be described using mean and SD,~     frequencies and percentages. Baseline differences between the two groups will be tested using~     ANOVA for continuous data, and the Chi-square for categorical data. Kruskall-Wallis (chi~     square) test will be used to find the association group assignment and WHO grades of OM and~     ANOVA and RANOVA tests will be used to find the association between group assignment and the~     pain scores. Bonferroni tests will be conducted to explore which of the three groups has the~     better outcomes.~   "
12798|NCT03399318|"~     The study will examine whether prophylactic and scheduled treatment with acetaminophen and~     ibuprofen can decrease the maximum temperature experienced during the acute illness in~     children with CNS malaria.~   "
12799|NCT03399305|"~     Despite emergence of new anticoagulants over the last few years, patients with advanced~     chronic kidney disease still have limited options and are usually managed with warfarin after~     venous thromboembolism or diagnosis of atrial fibrillation. The use of all direct oral~     anticoagulants is not recommended in patients with creatinine clearance below 15 mL/min.~     Apixaban has the lowest fraction of renal excretion (27%) and is sometimes used in patients~     with CKD V (GFR < 15 mL/min/BSA) and end stage renal disease (ESRD). Until recently, data on~     apixaban use in this population were limited to pharmacodynamics as patients with severe~     renal impairment were excluded from clinical trials. In a 2016 study, it was found that ESRD~     resulted in 36% increase in apixaban AUC but no increase in Cmax, and that hemodialysis had a~     limited impact on apixaban clearance.1 There are now data available on inpatient use of~     apixaban vs.coumadin in patients with creatinine clearance below 25 ml/min.2 There was no~     significant difference in bleeding events between the two groups but the study period was~     limited to a hospital admission and may not reflect bleeding risk of long-term~     anticoagulation.~      Use of warfarin in patients on hemodialysis entails several disadvantages in this population.~     The need for INR monitoring adds clinic visits for patients that already spend a great~     portion of their time in healthcare facilities. Numerous drug interactions, involving~     warfarin, complicate management of ESRD patients that are often on many medications. The~     reduced risk of intracranial bleeding on apixaban, compared to warfarin, in the ARISTOTLE~     study, is an important consideration in patients that may already be at increased risk due~     other factors such as uremia and concurrent antiplatelet agents.~   "
12800|NCT03399292|"~     Dry eye disease (DED) is a common ocular disease, especially in the elderly population.~     Despite many treatment approaches, instillation of topical lubricants remains the mainstay of~     therapy. However, most of the topical lubricants available are not very well characterised~     and data about efficacy is sparse.~      The aim of the present pilot study is to investigate the effect of topically administered~     lipid based eye drops on tear film lipid layer thickness in subjects with dry eye disease,~     Meibomian gland dysfunction, blepharospasm and healthy subjects.~      Tear film lipid layer and tear film thickness will be assessed using the Lipiview II~     interferometer and OCT. Measurements will be performed before instillation of the eye drops~     and every 10 minutes after instillation for one hour. One eye will receive lipid based eye~     drops, the other eye will receive no eye drops and will be used as control. The study eye~     will be chosen randomly. In addition, Dynamic Meibomian gland imaging, Schirmer I test,~     corneal fluorescein staining and determination of tear break up time (BUT) will be performed~   "
12801|NCT03399279|"~     The ultimate goal of periodontal therapy is the regeneration of periodontal tissues which~     have been destroyed due to periodontal disease. Different modalities have been proposed to~     obtain regeneration of periodontal tissues employing various bone grafts, bone substitute~     materials, guided tissue regeneration (GTR), combination of bone grafts or bone substitutes~     with GTR, and growth factors.~      So, a new, fully synthetic, nanocrystalline, unsintered, phase-pure hydroxyapatite (nano-HA)~     has been suggested as a potential material for enhancing periodontal and bone regeneration~     since its chemical composition and crystalline structure correspond to the calcium phosphate~     component of natural bone and may have greater potential for resorption compared with~     sintered hydroxyapatite.~      A study performed in 2012, on 14 patients with paired intrabony periodontal defects of ≥4 mm~     participated in split mouth design study. The defects in each subject were randomly selected~     to receive nano-HA paste in conjunction with papilla preservation flaps or papilla~     preservation flaps alone. Probing bone levels from a customized acrylic stent and probing~     pocket depths were measured at baseline and again 6 months following surgery. No differences~     in any of the investigated parameters were observed at baseline between the two groups.~     Healing was uneventful in all patients. Both treatments resulted in significant improvements~     between baseline and 6 months in all clinical and radio-graphic parameters. In conclusion,~     they found that the nano crystalline hydroxyapatite bone graft in combination with collagen~     membrane demonstrated clinical advantages beyond that achieved by open flap debridement~     alone.~      The concept of porous guided tissue membrane has been tested recently as a modality that~     could stimulate bone formation of critical sized bone defects. Kim and co-workers claimed~     that asymmetrically porous GBR membranes with dual BMP-2 and ultrasound stimulation may be~     promising for the clinical treatment of delayed and insufficient bone healing. For guided~     tissue regeneration in periodontal therapy, membrane perforations could allow for gingival~     stem cells and periosteal cells to take part in supracrestal regeneration. The perforated~     section of the membranes would stabilize supracrestal fibrin clot through mechanical~     interlocking of fibrin strands with the membrane pores providing more membrane and clot~     stability. It has been suggested that regenerative failures may result when the tensile~     strength of the fibrin clot is exceeded, resulting in a tear and a long junctional epithelium~     type attachment.~   "
12802|NCT03399266|"~     A prospective randomized controlled trial to evaluate the safety and efficacy of labor~     induction with a double balloon catheter (Atad Ripener Device) in women desiring TOLAC (trial~     of labor after cesarean) with PROM (pre labor rupture of membranes).~   "
12803|NCT03399253|"~     Our study aims to compare the efficacy and safety of Chemotherapy Alone Versus D2 distal~     gastrectomy and metastasectomy plus Chemotherapy for gastric cancer (GC) with one non-curable~     Factor~   "
12844|NCT03398720|"~     HTI-1066 is a novel ADC being developed for the treatment of cancers in patients with~     overexpression of c-Met. This 2-part, Phase 1 study evaluates the safety the tolerability of~     HTI-1066 in subjects with advanced solid tumors.~   "
14644|NCT03375255|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK)~     of 5 escalating doses of SRP-5051 administered as a single dose to patients with DMD amenable~     to exon 51 skipping treatment.~   "
12804|NCT03399240|"~     This is a single site evaluation study of Vitastiq device accuracy in healthy men and women~     in ratio 1:1 (approximately) aged between 18 and 64 years. A total of 45 Vitastiq personal~     devices will be used by volunteers for two months. The Vitastiq device will be evaluated~     during three site visits: on day 1, 29 ± 4 days and 57 ± 4 days. During site visit days,~     blood sampling will be collected and analysed and readings using Vitastiq device will be~     performed. Data will be analysed retrospectively to evaluate Vitastiq performance compared to~     blood tests results.~   "
12805|NCT03399227|"~     Fifty patients awaiting liver transplantation and 50 age and gender matched control subjects~     with normal liver function will be included in the study. The aim of this project is to~     compare liver transplantation recipients'bone microarchitecture with healthy controls and to~     evaluate patients' changes within one year after transplantation~   "
12806|NCT03399214|"~     The objective of the study is to assess the dose dependent changes in MRI signal intensity~     (SI) in liver after IOP Injection intravenous administration in healthy volunteers.~   "
12807|NCT03399201|"~     The role of neuraxial anesthesia in preventing respiratory complications is a controversial~     in elderly patients. The aim of the study was to evaluate the benefits of neuraxial~     anesthesia on pulmonary function during post-operative term in geriatric patients undergoing~     to elective non-abdominal surgery.~   "
12808|NCT03399188|"~     Fecal microbiome of donor and recipient will be analyzed before and after fecal microbiota~     transplantation in IBD patients.~   "
12809|NCT03399175|"~     This prospective study will include patients with Vogt-Koyanagi-Harada disease from disease~     onset, treated with early systemic high-dose corticosteroid and immunosuppressive therapy.~     Clinical and subclinical signs of disease activity added with electroretinogram exams,~     through predefined intervals, will be evaluated through a minimum 12-month follow-up.~   "
12810|NCT03399162|"~     Older and more frail adults are more often being referred for cardiac surgery. These patients~     are often in suboptimal health, and may be physically frail, malnourished, and have other~     conditions, such as diabetes, that complicate their recovery. Research suggests that a~     rehabilitation program prior to surgery may help improve participants' health and improve~     their fitness for surgery. Currently, a pre-operative rehabilitation workshop is offered at~     the University of Ottawa Heart Institute, but this interventional, randomized study will~     investigate whether a more comprehensive pre-operative regime, including structured weekly~     exercise program, is more effective at improving health prior to surgery. Patients will be~     randomized to either the control group (pre-operative rehabilitation workshop ONLY) or the~     treatment group (pre-operative rehabilitation workshop plus exercise regime). This regime~     will attempt to improve patients' overall health, including their physical fitness and~     nutritional status. The effectiveness of this regime will be evaluated by comparing patients'~     physical function, questionnaires (diet, quality of life, stress) and serum biomarkers from~     baseline to pre-surgery to post-surgery. The Investigators hypothesize that patients that~     complete the pre-operative rehabilitation program will improve their health prior to surgery,~     and that this may result in shorter length of hospitalization and fewer complications after~     surgery. The study will take place over two years, with each patient's participation lasting~     about 3 months.~   "
12811|NCT03399149|"~     Over the last two decades, the number of patients with hematological malignancies (HMs)~     admitted to the ICU increased and their mortality has dropped sharply. Patients with HMs~     increasingly require admission to the intensive care unit (ICU) for life-threatening events~     related to the malignancy and/or treatments, with immunosuppression being a major~     contributor. Whether the increase in ICU admissions is related to increased referrals by~     hematologists and/or to increased admissions by intensivists is unknown. The criteria used~     for ICU referral and admission decisions have not been extensively evaluated. Finally, the~     links between admission policies and treatment-limitation decisions are unclear, but ICUs~     with broad admission policies may change the treatment goals based on the response to several~     days of full-code management.~      The aim of this study is to evaluate the impact of a systematic evaluation by an intensivist~     of HMs patients presenting with acute respiratory and/or hemodynamic failure.~   "
12812|NCT03399136|"~     The study objective was to determine the safety and efficacy of aerobic exercise in older~     HIV-infected men in a randomized trial comparing different levels of exercise intensity.~   "
12813|NCT03399123|"~     To explore the effect of low tidal volume on blood loss and gas exchange during laparoscopic~     hepatectomy~   "
12814|NCT03399110|"~     Our study aims to compare the efficacy and safety of capecitabine and oxaliplatin for 4~     months versus 6 months as adjuvant chemotherapy after D2 Gastrectomy in patients with gastric~     cancer.~      Hypothesis: For gastric patients after D2 Gastrectomy, capecitabine and oxaliplatin for 4~     months shows noninferiority to capecitabine and oxaliplatin for 6 months in disease free~     survival(DFS) and safety.~   "
12815|NCT03399097|"~     The enteroendocrine system is composed from different cells along the different parts of the~     gastrointestinal tract, secreting diverse hormones and bariatric surgery alters intestinal~     hormone secretion, affecting glycemic control and weight. The aim of the study is to~     characterize the composition and secretory profile of enteroendocrine cells in the obese,~     non-obese and non-obese post bariatric surgery.~   "
12816|NCT03399084|"~     This study will evaluate bioequivalence of two formulations of Ferric Carboxymaltose as~     measured by serum total iron, in adult patients with iron deficiency anemia.~   "
12817|NCT03399071|"~     A single centre phase II trial of peri-operative chemo-immunotherapy in operable~     gastro-oesophageal adenocarcinoma (GOA). This trial is designed to evaluate the safety and~     efficacy of administering Avelumab, an anti-PD-L1 monoclonal antibody, with cytotoxic FLOT~     chemotherapy for patients with operable GOA treated according to a peri-operative protocol.~      This trial is in 2 stages: the first stage will establish the safe and tolerated maximum~     administered dose (MAD) of Avelumab in combination with FLOT and the second stage will assess~     the efficacy of this combination therapy in achieving pathological complete response (pCR)~     and peri-operative safety.~   "
13332|NCT03392350|"~     We evaluated the effectiveness of a combination of a comprehensive health assessment~     consisting of the combination of a screening full body scan employing graphic patient~     education and motivational techniques followed by intensive, individualized behavioral~     training and management program on improved adherence to beneficial lifestyle behaviors, as~     well as possibly reduced risk of disease.~   "
12818|NCT03399058|"~     The project is the collaboration with the lead agencies National Institute of Public Health,~     World Vision and Emory University World Vision has a history of successfully implementing~     Positive Deviance/Hearth (PDH) programs across the globe. PDH is a community-based~     intervention utilizing locally appropriate health and infant feeding practices to~     rehabilitate underweight children and promote behavioral changes in caregivers. A recent~     systematic review on the PD/Hearth approach found that although some programs show clear~     success in particular settings, overall, the results were mixed for program effectiveness.~      Furthermore, with the growing use of mobile phones and technology in the world, including~     Cambodia, there have been various studies and a systematic review that found SMS reminders~     and voice recordings to have promising impact on behavior change of patients for smoking~     cessation and improved adherence to drugs for asthma patients. Although there are positive~     findings around the use of mobile devices to improve behavior change, there has yet to be a~     study that examines the impact of mobile phones on improving behavior change of caregivers~     related to nutrition, water, sanitation and hygiene (WASH), health, and caring practices,~     which as a result, would decrease the prevalence of underweight in children 6-23 months of~     age.~      This study will provide evidence on the effectiveness of the PDH model in Cambodia compared~     to the current standard of care. Investigators believe the PDH approach will be a powerful~     tool to reduce child malnutrition. In addition, given the intensity and cost burden~     associated with PDH, investigators will simultaneously test if the intensity of the PDH model~     can be reduced by introducing an innovative application of mHealth to replace 50% of~     face-to-face education sessions (5 days) and all follow up visits with mobile support calls.~     Collectively this research will provide critical data to inform program operations on the~     optimal and most effective method to reduce child underweight in Cambodia.~      In Year 1, the purpose of this study is to assess the effectiveness of contextualized~     messages through PDH programs and a mobile technology (mHealth), to improve knowledge,~     behaviour change, and level of confidence of caregivers with underweight children aged 6-23~     months in feeding, hygiene, health-seeking, and caring practices. In Year 2, the study's aim~     will be to assess the prevention of underweight in the siblings of the children included in~     the three programs outside of the 360 study subjects from Year 1.~   "
12819|NCT03399045|"~     A withdrawal time of at least 6 minutes has been considered to be necessary to guarantee the~     adenoma detection rate and the critical quality criterion of colonoscopy. However, several~     large observational investigations demonstrated that 9 minutes will be in favor of higher~     adenoma detection rate and lower risk of interval colorectal cancer, when compared with~     6-minute withdrawal. Meanwhile, a few studies also indicated that no significant benefit were~     observed in longer withdrawal time. Up to now, no randomized controlled trials have been~     conducted to give a definitive conclusion. Therefore, we performed a multicenter,~     prospective, randomized Controlled trial to compare adenoma detection rate of 6-minute and~     9-minute withdrawal in colonoscopy.~   "
12820|NCT03399032|"~     The objective of this study is to describe the pharmacokinetics of standard doses of~     caspofungin in critically ill patients.~   "
12821|NCT03399019|"~     This study is to investigate on the objective relevance between bispectral index (BIS) and~     Observer's assessment of alertness/sedation (OAA/S) scale in patients sedated with Midazolam,~     propofol and dexmedetomidine during spinal anesthesia. Also, we will evaluate the reflection~     of actual sedation levels on BIS monitoring.~   "
12822|NCT03399006|"~     200 women at risk factor for preeclampsia will be subjected to transabdominal Doppler~     ultrasonography for assessment of placental volume measurements, pulasatility index (PI) and~     resistivity index (RI) in both uterine arteries, and assessment of the placental volume and~     its vascular indices (VI, FI, VFI)~   "
12823|NCT03398993|"~     100 patient of unexplained infertility recruited and divided into two groups for the study~     group (50) endometrial scratching done in preovulatory period after controlled ovarian~     stimulation by clomiphene citrate , then followed and compared to control group for 6 months~     to asses pregnancy rate~   "
12824|NCT03398980|"~     Although children and adolescents are more likely to have advanced disease at onset, they~     generally have a significantly better chance of survival. With combined chemotherapy and~     radiotherapy, overall survival has been reported more than 75% in most pediatric studies.~     However, little research focuses on long-term morbidities of children and adolescent~     nasopharyngeal carcinoma (NPC) survivors, and most studies are small scale and have short~     follow-up time. Therefore, this study analyzed the long-term morbidities of children and~     adolescent NPC survivors after radiotherapy. Factors associated with those morbidities were~     also analyzed.~      We reviewed the medical records of all NPC patients younger than 18 years old treated at Sun~     Yat-sen University Cancer Center (SYSUCC) from February 1991 to October 2010. Detailed~     medical records were taken from our institutional database. Patients were also followed using~     comprehensive questionnaires and phone calls. We extracted data on clinical characteristics,~     histopathology, imaging findings, treatment, outcomes, and late morbidities.~      Patients with early-stage (stage I and II) disease were treated with radiotherapy alone, and~     patients with advanced-stage disease (stage III and IV) were treated with a combination of~     radiotherapy and chemotherapy. Radiotherapy technology included conventional radiotherapy~     (CRT) and intensity-modulated radiotherapy (IMRT).~      We retrospectively reviewed these medical records to collect the required data. All survivors~     returned to the hospital for follow-up examinations at least every 3 months for the first~     year, at least every 6 months in the 2nd year, and at least every one year thereafter until~     the latest follow-up. As part of our routine clinical practice, all patients underwent~     follow-up MRI examinations of the nasopharynx and neck at least every 6 to 12 months.~      Radioactive toxicity on organs was evaluated based on National Cancer Institute Common~     Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0.~      Analyses were performed using SPSS software, version 16.0 (SPSS, Chicago, IL). Chi-squared~     tests and binary regression analysis were used to compare the CI of treatment comorbidities~     between different groups of survivors. A P value of 0.05 was chosen as the criteria for~     statistical significance.~   "
12825|NCT03398967|"~     CD19-directed CAR-T cell therapy has shown promising results for the treatment of relapsed or~     refractory B-cell malignancies; however, a subset of patients relapse due to the loss of CD19~     in tumor cells. Dual Specificity CD19 and CD20 or CD22 CAR-T cells can recognize and kill the~     CD19 negative malignant cells through recognition of CD20 or CD22. This is a phase 1/2 study~     designed to determine the safety of the allogenic gene-edited dual specificity CD19 and CD20~     or CD22 CAR-T cells and the feasibility of making enough to treat patients with relapsed or~     refractory hematological malignancies.~   "
12845|NCT03398707|"~     This prospective observational cohort study will investigate the impact of a bundle of nine~     preventive measures (Assessment, prevention and management of pain; spontaneous awaking~     trial; spontaneous breathing trial; choice of sedation and analgesia; delirium assessment,~     prevention and management; early mobility; family communication and ICU Diary) on the~     incidence and severity of Post-Intensive Care Syndrome (PICS) and clinical outcomes in~     critically ill patients~   "
12846|NCT03398694|"~     This is a prospective, single arm, phase II trial to determine the local control at 6 months~     utilizing pre-operative stereotactic radiosurgery followed by surgery within 1 - 3 days in~     subjects with a diagnosis of 1-4 brain metastases and with an indication for surgical~     resection of at least one brain metastasis at the discretion of a neurosurgeon.~   "
12873|NCT03398343|"~     Critically ill patients with body mass index (BMI) inferior to 20 kg/m2 have worse outcomes~     compared to normal and overweight patients. The impact nutrition therapy in this population~     is not yet stablished. There is a concern that too low caloric intake might worse their~     malnutrition; on the other hand, overfeeding is always a risk with serious consequences.~      The hypothesis of this study is that nutritional support, especially caloric and protein~     intake, can influence the outcome of underweight critically ill patients.~   "
12826|NCT03398954|"~     1. Primary Objective To estimate the prevalence of clinical diagnosed familial~          hypercholesterolemia, as well as the clinical characteristics and current treatment,~          with applying China recent issued FH screening protocol in pilot outpatient department~          of China.~        2. Study Design The study is a prospective observational research study of clinical~          diagnoses FH patients in outpatient department in pilot hospitals to evaluate the~          screening out rate and the clinical feature and management of FH patients including~          HoFH, with applying China recent issued FH screening protocol.~        3. Eligibility 3.1.Inclusion Criteria Written inform consent provided. Male and female~          cardiovascular outpatients and inpatients with LDL-C>4.65mmol/L if statin naïve or~          LDL-C>3.7mmol/L if on statin treatment before enrollment during Sept.2017 to Sept. 2019.~           3.2Exclusion Criteria Subjects who cannot understand study procedure Subjects diagnosed~          as secondary dyslipidemia~        4. Primary Endpoint~             -  The screening out rate of clinical diagnosed familial hypercholesterolemia, with~               applying China recent issued FH screening protocol in subjects with~               LDL-C>4.65mmol/L if statin naïve or LDL-C>3.7mmol/L if on statin treatment in pilot~               outpatient department of China.~             -  The clinical characteristics of clinical diagnosed FH patients(including HoFH and~               HeFH), including: demography, medical history, family history, sign and symptoms,~               lab testing and cardiovascular imagine result.~             -  The pharmaceutical therapy for clinical diagnosed FH patients (including HoFH and~               HeFH), including the type of medication, proportion for each medication, dosage and~               treatment duration.~   "
12827|NCT03398941|"~     The Effect of Preoperative Long Period Octreotide Combined With Postoperative Short Period~     Octreotide on the Complications After Pancreatectomy. A Prospective, Multicenter Clinical~     Trial~   "
12828|NCT03398928|"~     Delirium frequently occurs in hospitalized older people, and treatment options are limited.~     Acupuncture has been shown to reduce agitation in the setting of dementia. The investigators~     will test the hypothesis that it may also assist in treating delirium.~   "
12829|NCT03398915|"~     In a multinational prospective registry, preoperative, intraoperative, perioperative and~     follow-up data on patients receiving thoracolumbar pedicle screw placement for degenerative~     disease or infections or tumors will be collected. The three arms consist of robot-guided~     (RG), navigated (NV), or freehand (FH) screw insertion.~   "
12830|NCT03398902|"~     This study will use continuous glucose monitoring and actigraphy to examine whether a~     personalized, daily sleep extension intervention improves glucose regulation for community~     dwelling, sleep-restricted adults with pre-diabetes. The randomized controlled trial will~     include 150 adults with pre-diabetes. Sleep extension and habitual sleep groups will complete~     daily sleep diaries and participate in a weekly 15-minute telephone call or videoconference~     meeting with a member of the study team (8 sessions total). Data collection will be at 2 time~     points: pre-randomization and post-intervention (completion of the 8-week intervention).~     Changes in the percent time glucose is ≥ 140mg/dL at baseline and post-intervention will be~     established and compared across the sleep extension and habitual sleep arms.~   "
12831|NCT03398889|"~     Patients attending stroke prevention clinics and a premature atherosclerosis clinic at~     University Hospital in London, ON, Canada were recruited to the study. They completed a~     dietary questionnaire, provided stool samples and had blood drawn to measure plasma levels of~     metabolites produced by the intestinal bacteria.~   "
12832|NCT03398876|"~     In Part 1, the purpose of this study is to elucidate the single-dose pharmacokinetic profiles~     of 1 spray and 2 consecutive sprays of oromucosal nicotine spray (ONS) in comparison with~     those of nicotine gum and cigarette smoking in healthy Japanese smokers. In Part 2, the~     purpose is to evaluate the multiple-dose nicotine pharmacokinetics of ONS administered~     repeated-dose administration in healthy Japanese smokers.~   "
12833|NCT03398863|"~     400 women who came to our Department for Cesarean Section delivery will be divided into 2~     groups: Group1:Cleaning the uterine cavity 200 patients Group2:No Cleaning of uterine~     cavity 200 patients~   "
12834|NCT03398850|"~     A retrospective and prospective registry will evaluate demographic and angiographic data in~     patients with spontaneous coronary artery dissection (SCAD) using medical records, invasive~     coronary angiography, intravascular imaging and/or computed multislice coronary tomography.~     The type of treatment applied during index hospitalization (i.e., clinical management,~     percutaneous coronary intervention or coronary artery bypass grafting) will be evaluated.~     Long-term follow-up (up to 10 years) will be also reported.~   "
12835|NCT03398837|"~     This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study assessing~     the efficacy and safety of lenabasum for the treatment of diffuse cutaneous systemic~     sclerosis (SSc). Approximately 354 subjects will be enrolled in this study at about 60 sites~     in North America, Europe, Australia, and Asia. The planned duration of treatment with study~     drug is 52 weeks.~   "
12836|NCT03398824|"~     This is a single institution, open-label, single arm pilot study of Metformin in patients~     with Fanconi Anemia (FA) and cytopenias with the primary endpoint of hematologic response.~     This study will also assess safety, tolerability, and the biologic effects of Metformin in~     patients with FA.~   "
12847|NCT03398681|"~     Recent studies have shown that treatment with intravenous iron in patients with iron~     deficiency (ID) and heart failure with reduced ejection fraction (HFrEF) improves~     symptomatology, functional capacity, quality of life, and decreases hospitalizations~     regardless of anemia. In addition, a decrease in myocardial iron content has been observed in~     patients with chronic HFrEF. This preliminary evidence has led to postulate that myocardial~     iron deficiency could play a direct role in the pathogenesis and progression of the disease.~      The investigators hypothesize that the repletion of myocardial iron would explain part of the~     benefit of this treatment. Thus, the investigators postulate that cardiac magnetic resonance~     (CMR) (T2* and T1-mapping sequences) will be sensible enough to detect changes in myocardial~     iron content as a result of intravenous iron administration, and that such changes will~     correlate with simultaneous changes in parameters of heart failure severity.~      In this double-blind 1:1 randomized study controlled by placebo the investigators aim to~     determine the changes in myocardial iron content after treatment with intravenous ferric~     carboxymaltose (FCM) by CMR at 7 and 30 days in patients with stable HFrEF and ID.~   "
13333|NCT03392337|"~     A single center study of 30 patient receiving Narrowband UVB phototherapy three times weekly~     for 12 weeks. Patients will be evaluated through week 36 to evaluate maintenance of response.~   "
12837|NCT03398811|"~     The use of progestin-only methods of contraception has been increased obviously and~     progressively over the world in the last few years. Progestin-only contraception is an option~     for women in whom an estrogen-containing contraceptive is either contraindicated or causes~     additional health concerns.~      Progestogen-only pills are contraceptive pills that contain only synthetic progestogens~     (progestins) and do not contain estrogen . The progestin-only pill is recommended over~     regular birth control pills for women who are breastfeeding because the mini-pill does not~     affect milk production.~      The most common progestin-only method used is the injectable depot medroxy-progesterone~     acetate which had been approved by Food and Drug Administration since 1992 . depot~     medroxy-progesterone acetate provides reliable, private, long-acting (three months) and~     reversible contraception. Users of depot medroxy-progesterone acetate don't need daily taking~     as well as it doesn't affect the intercourse by any mean.~      The etonogestrel implant (Implanon) is a single-rod progestin contraceptive method placed~     subdermally in the inner aspect of upper non dependant arm for three years. Much evidence~     supports the safety, efficacy, reversibility and acceptability of this contraceptive method.~      A common reason women choose to discontinue progestin-only contraception is dissatisfaction~     with its effects on uterine bleeding which occurs in a significant number of users.~     Information revealed from many clinical trials shows that abnormal uterine bleeding with~     progestin-only contraception ranging from 10 to 25 % at first year of use.~   "
12838|NCT03398798|"~     Purpose: This project aims to study the effects of wire dimension and ligation method~     (bracket type) on the first stage of orthodontic treatment using 3D imaging.~      Participants: Up to 80 patients at UNC School of Dentistry or Selden Orthodontics between the~     ages of 10 and 45, inclusive, who have been previously diagnosed with malocclusion requiring~     orthodontic treatment (braces) and are otherwise healthy.~      Procedures (methods): Subjects receiving standard of care (SOC) orthodontic treatment will be~     randomized to one of two commonly used orthodontic archwires (.014 or .016 diameter).~     Subjects will be further subdivided for analysis based on the type of bracket (twin or~     self-ligating) that their clinician uses in their treatment. We will review the 3D digital~     images of each subject's dentition recorded as part of SOC at the 0-, 6- and 12-week visits.~     We will retrieve the archwires when they are removed per SOC by the clinician at the 12-week~     time point.~   "
12839|NCT03398785|"~     Primary aldosteronism (PA) is one of the most common cause of endocrine and resistant~     hypertension. Current studies have shown that the activation of the~     renin-angiotensin-aldosterone system (RAAS) and the increased sympathetic nerve activity in~     the central or local tissue are the key mechanisms of high blood pressure and its organ~     damages.~      The classical method for diagnosis of primary aldosteronism depends on the detection of~     peripheral venous blood aldosterone level, which is incapable of accurate positioning~     diagnosis. On the other hand, the current guidelines recommend that surgery and aldosterone~     receptor inhibitors were the only treatment for primary aldosteronism. However, only about~     35% of aldosterone tumors and a small part of unilateral adrenal hyperplasia can be treated~     by surgery. More than 60% of idiopathic aldosteronism and bilateral adrenal hyperplasia need~     long-term drug therapy. However, long-term aldosterone inhibitor treatment may also cause~     hyperkalemia, male breast hyperplasia, female hirsutism and other adverse reactions.~      Therefore, the investigators proposed that endovascular chemical partial ablation of the~     adrenal gland can lower the aldosterone level, reduce the blood pressure and recover the~     potassium metabolism balance. In order to confirm the above effects, the investigators~     conduct an open, prospective, positive controlled study in patients with primary~     aldosteronism patients (including aldosterone, idiopathic aldosteronism and adrenal~     hyperplasia). The effects on blood pressure, blood electrolytes, adrenal hormones, metabolic~     indexes, target organ damages were observed to explore the efficacy and safety of the~     endovascular ablation of the adrenal gland in the treatment of primary aldosteronism.~   "
12840|NCT03398772|"~     Chronic obstructive pulmonary disease due to incurable and prevalence has increased steadily,~     chronic respiratory disease is considered hazardous to health and quality of life of the~     disease. GOLD treatment guidelines (global initiative for chronic obstructive lung disease~     guideline) pointed out the pulmonary rehabilitation is one of the non-drug treatment in~     patients with severe COPD, shown to improve exercise capacity and reduce the short of~     breathing, improve the quality of life and reduce the anxiety associated and depression and~     improved survival advantages. Meanwhile, a few studies have examined effect the exercise~     training in severe COPD patients' symptom distress and quality of life, so as to make severe~     COPD patients to improve the effectiveness of the campaign to ongoing regular pulmonary~     rehabilitation movement, is considered an important issue.~      It has been proposed that physical activity enhancement or exercise training can be effective~     in improving symptoms and quality of life in these patients. However, it has not been~     examined systematically. Therefore, the main purposes of this study are: 1.Prevalence of~     symptom distress; 2.The physical preferences; 3.The relationship between quality of life and~     physical activity; 4.Effects of Comprehensive Health coaching exercise training on improving~     fatigue, sleep disturbances, quality of life, readmission, and survival. In the first year of~     this study, a descriptive-correlational design will be used and in the second and third years~     of study, the experimental design and prospective longitudinal study will be undertaken.~     Instruments include motion sensors, physical activity scale, Physical Activity Preferences,~     Pittsburgh Sleep Quality of Life Index. Statistical analyses include descriptive statistics,~     t-test, one-way ANOVA, latent growth modeling, Logistic models, GEE, and survival analysis.~     Results from this study will provide important implications for improving symptom management~     and quality of life for sever chronic obstructive pulmonary disease patients.~   "
12841|NCT03398759|"~     Emergence agitation is one of the common postoperative complications after functional~     endoscopic sinus surgery（FESS). The objective of present study is to explore the~     effectiveness of butorphanol in the alleviation of emergence agitation in patients undergoing~     Functional Endoscopic Sinus Surgery.~   "
12842|NCT03398746|"~     This prospective, randomized controlled trial enrolled a convenience sample of adults and~     children presenting to two Level 1 trauma centers over 12-months with subcutaneous skin~     abscesses necessitating drainage. Two methods of drainage were compared: 1) the LOOP~     technique or 2) standard packing technique.~   "
12843|NCT03398733|"~     The prevalence of OSA (Obstructive sleep apnea，OSA) is 2%-4% in general population and~     16%-47% in surgical-heart failure patients. Our previous study found that OSA was associated~     with the increasing incidence of perioperative adverse events.The continuous positive airway~     pressure (CPAP), as the standard treatment for OSA, is extensively applied clinically. The~     previous study reported that postoperative AHI was reduced and SPO2 was increased by CPAP~     treatment. However, whether CPAP treatment can improve OSA postoperative and related adverse~     events or not in patients with rheumatic valvular heart diseases (RVHD) were not reported.The~     purpose of this study is to observe the effective of preoperative CPAP on postoperative sleep~     parameters and adverse events, such as AHI changes, duration of ICU stay and duration of~     mechanical ventilation.~   "
12850|NCT03398642|"~     To address population aging, health professionals, including occupational therapists, need to~     engage in effective interventions. The preventive occupational therapy intervention called~     Lifestyle Redesign® empowers older adults to regularly perform healthy and fulfilling~     activities. Lifestyle Redesign® has been shown to benefit physical and mental health and be~     cost-effective.~      This pilot study explored the influence of Lifestyle Redesign® on older French- Canadians'~     health, social participation, leisure and mobility. Method: A mixed-method design was used~     with 16 participants (10 women) aged 65-90 (76.4±7.6 y), 10 without and 6 with disabilities.~     Health, social participation, leisure and mobility questionnaires were administered before~     and after the 6-month intervention, as well as 3 and 6 months post-intervention.~     Semi-directed interviews were also conducted.~   "
12851|NCT03398629|"~     The purpose of this prospective cohort study is to build a large platform that includes~     clinical information (prenatal diagnosis and postnatal follow-up data) and biological~     specimen banks of fetuses/infants with IUGR or congenital anomalies, which provide vital~     support and research foundation for accurate diagnosis, precision treatment and meticulous~     management.~   "
12852|NCT03398616|"~     Autoregulation is defined as the ability of a vascular bed to adapt its vascular resistance~     to changes in perfusion pressure. In the eye, several studies have reported that retinal~     blood flow is autoregulated over a wide range of ocular perfusion pressures. Large scale~     studies have shown that reduced ocular perfusion pressure is an important risk factor for the~     prevalence, the incidence and the progression of primary open angle glaucoma. There is also~     evidence that autoregulation is impaired in patients with primary open angle glaucoma.~      To gain more insight into these phenomena in humans is the primary goal of the present study.~      The present study aims to investigate the pressure/flow relationship as a measure for retinal~     blood flow autoregulation during an experimental increase in intraocular pressure by the use~     of the suction cup technique. Retinal blood flow will be measured by Doppler OCT.~   "
12853|NCT03398603|"~     The developement of a new, stable measurement of the Antimuellerian Hormon (AMH) together~     with Roche Diagnostics International (Rotkreuz, CH) shall enable an automized and timely~     measurement of AMH values in blood samples.~   "
12854|NCT03398590|"~     This is a pilot study to test the feasibility and acceptability of a self-regulation~     theory-based mHealth behavior intervention for overweight or obese older adults with T2DM.~   "
12855|NCT03398577|"~     The aim of this study is to explore the effect of newly added SGLT2I medication or placebo,~     to standard medication regimen in diabetic patients with documented stable coronary disease.~     Therefore, in the present study the investigators plan to focus on possible anti-inflammatory~     and athero-thrombotic protective effects of Dapagliflozin compared to placebo, in secondary~     prevention population of stable coronary patients with diabetes. Additionally, the~     investigators will explore NT proBNP dynamics, which related to ventricular filling pressures~     in this specific population.~   "
12856|NCT03398564|"~     Laparoscopic cholecystectomy is a widely employed procedure in ambulatory surgery. Pain after~     laparoscopic cholecystectomy arises significantly from port site incisions in the anterior~     abdominal wall. Innervation of the anterior abdominal wall is segmentally supplied by pain~     afferents in the plane of fascia between transversus abdominis and the internal oblique~     muscles. Opioids analgesia is used to control postoperative pain, but it carries the risk of~     increased nausea and vomiting, ileus and sedation that may delay hospital discharge.~      Several techniques have been tried as.neuroaxial narcotics, intraperitoneal lavage of local~     anesthetic and transversus abdominis plan (TAP) block and successfully reduced opioid use and~     improve postoperative analgesia.~      The ultrasound-guided erector spinae plan(ESP) block is a recently described technique which~     produces reliable unilateral analgesia at thoraco-lumbar dermatomes. ESP block carries the~     advantages of being simple, safe, easily recognizable by ultrasound, and a catheter can be~     threaded to extend the duration of analgesia.~      Few case series reported the efficacy of (US)-guided ESP blocks in reducing postoperative~     pain and opioids consumption.~      Because of that, the investigators aimed to test the hypothesis that US-guided ESP blocks can~     decrease opioid consumption during the first 24 h after of laparoscopic cholecystectomy in~     comparison with the conventional systemic analgesia.~   "
12857|NCT03398551|"~     The aim of this study is to get a proof of concept for using a computational model of fetal~     haemodynamics, combined with machine learning based on Doppler patterns of the fetal~     cardiovascular, cerebral and placental flows, to identify those at increased risk of adverse~     perinatal outcomes such as stillbirth, perinatal mortality and other neonatal morbidities.~      We will also compare the sensitivity and specificity of UmbiFlow device with the machine~     learning model in predicting adverse perinatal outcomes~   "
12858|NCT03398538|"~     This study is a prospective, multi-center, randomized controlled trial designed to collect~     patient outcome data on 2 commercially available SOC dressings treatments for Diabetic Foot~     Wounds~   "
12859|NCT03398525|"~     Intensive care unit patients who have to undergo central venous catheter insertion and are~     able to hear explanations and to gave consent, will be randomized to either usual care during~     catheter insertion or to a musical intervention added to usual care.~      The primary objective will be to assess the patient's anxiety just after catheter insertion.~     Secondary outcome measures will be the patient-reported pain, the duration of catheter~     insertion, and the need for additional anxiolytic or sedative drugs during catheter~     insertion.~   "
12860|NCT03398512|"~     The prognosis of patients with unresectable peritoneal metastases from colorectal cancer is~     poor. These patients may obtain survival benefit from radical colorectal resection and~     cytoreductive surgery (CRS). The response rates of previous conversion therapy are low.~     Hyperthermic intraperitoneal chemoperfusion (HIPEC) and systemic chemotherapy are effective~     methods of reducing peritoneal cancer index (PCI) levels. The purpose of this study is to~     investigate the efficacy and safety of HIPEC and systemic chemotherapy in the conversion~     therapy of peritoneal metastases from colorectal cancer.~   "
12874|NCT03398330|"~     An open-label, single dose, randomized, cross-over study to confirm the bioequivalence (BE)~     of OTR tablet 40 mg and OXYCONTIN tablet 40 mg in a fed state in Chinese subjects with~     chronic pain.~   "
12875|NCT03398317|"~     On the day of ICSI, choosing the best sperm by either PICSI or magnetic activated cell~     sorting (MACS) in cases with abnormal DNA is not fully investigated. This study helps in~     solving this problem by using two known techniques to achieve that purpose.~   "
12861|NCT03398499|"~     Orthognathic surgery procedures are often used to correct for skeletal II and III skeletal~     deformation, dental-facial-maxillary deformation, mandibular laterognathy and maxillofacial~     asymmetry. The factors that motivate patients to undergo this procedure are: improvement of~     chewing, speech and swallowing as well as aesthetic and psychosocial factors. Correction of~     occlusal-facial defects requires team orthodontic, surgical and rehabilitation treatment. As~     with any surgical procedure, various preoperative, intraoperative and postoperative~     com-plications may occur. Late complications that may occur in variously long periods of time~     from surgery include among others dysfunction of the temporomandibular joint, idiopathic~     atrophy of the condyloid muscles and associated pain. After orthognathic operations, pain~     occurs almost always, although the degree of its severity is a subjective sensation of each~     patient. Regardless of intensity, the fight against pain is one of the basic activities in~     post-operative care of the patient. The aim of the study was to evaluate the effectiveness of~     the physiotherapeutic method, which uses a slow-changing electromagnetic field and light~     ener-gy emitted from high-energy LEDs - light emitting diode, Magnetholedoterpy, in reducing~     pain in patients after orthognathic surgery Using the Viofor JPS device (Med & Live)~   "
12862|NCT03398486|"~     In patients with a long-lasting TMD syndrome, especially of a muscular nature, palpation~     examination can locate the trigger points of pain (TrP) in the chewing muscles, i.e., the~     nodules in the shape of bumps the size of rice or pea grains. Kinesiotaping (KT) is~     considered as an intervention method that can be used to release latent myofascial trigger~     points. It is a method that involves applying specific tapes to the patient's skin surface in~     order to use the natural self-healing processes of the body. The aim of the study was to~     evaluate the effect of Kinesiotaping methods and inactivation of Trigger Points on~     nonpharmacological elimination of pain in patients with functional disorders of the~     masticatory motor system.~   "
12863|NCT03398473|"~     This study will assess the PK similarity of epoetin administered as Hospira MDV versus~     Hospira SDV by conducting a single-dose comparative evaluation in normal healthy subjects~     enrolled at a single center.~   "
12864|NCT03398460|"~     Given the stress, exhaustion and close interface with death that Intensive Care Unit (ICU)~     health care providers face, this study will evaluate burnout rates in intensive care unit~     (icu) physicians, nurses and ancillary staff. Investigators will also study the effect on a~     bereavement card on these burnout rates~   "
12865|NCT03398447|"~     The aim of this study is to show Endocuff Vision could improve insertion because during loop~     withdrawal the cuff tends to stabilize the position of the tip, preventing its backward~     movement and speeding loop removal. Similarly, during inspection the main goal is to evaluate~     the proximal sides of folds and flexures. The process is made easier and quicker by the~     device. Third, during polypectomy, Endocuff Vision helps to stabilize the position and the~     scope tip.~   "
12866|NCT03398434|"~     The purpose of this study is to evaluate the pharmacokinetics, pharmacodynamics, safety and~     tolerability of MAA868 compared to apixaban in patients with atrial fibrillation.~   "
12867|NCT03398421|"~     Nemiralisib is a potent anti-inflammatory agent for the treatment of chronic obstructive~     pulmonary disease (COPD) and other inflammatory lung diseases. The Cytochrome P450 3A4~     (CYP3A4) is a major route of clearance for nemiralisib. The co-administration of drug~     therapies, which modulate CYP3A4, may alter the exposure of nemiralisib. Hence, this clinical~     drug interaction study with itraconazole (a potent CYP3A4 inhibitor) is required. The study~     will evaluate the PK, safety and tolerability of nemiralisib when administered alone and when~     administered concomitantly with repeat doses of itraconazole in healthy males and females.~     Subjects will receive treatment with nemiralisib alone in Period 1 and itraconazole followed~     by nemiralisib in Period 2 in single sequence crossover manner. Approximately 20 subjects~     will be enrolled such that approximately 16 evaluable subjects complete the study. Each~     subject will participate in the study for approximately 7 weeks including screening visit, 2~     treatment periods and a follow up visit.~   "
12868|NCT03398408|"~     To determine whether participation in a cognitive training program over a training period of~     five weeks improves cognitive flexibility in patients with chronic hip, knee, and back pain.~   "
12869|NCT03398395|"~     Use chairside Computer-Aided Design & Computer-Aided Manufacturing(CAD/CAM) system (computer~     aided design / manufacture), using glass ceramic zirconia enhanced lithium silicate glass~     ceramics (VITA, SUPRINITY, VS) material, compare the difference of firmness, comfort and~     durability between two kinds of root canal restoration methods:endocrown and 90° shoulder~     endocrown. Objective to establish the optimal method and material for the restoration of the~     teeth with root canal therapy.~   "
12870|NCT03398382|"~     The operation of the lower third molars is one of the most common oral surgery procedures in~     the world. The surgery is mostly done in local anesthesia which makes the surgery as pleasant~     as possible for the patient. In addition to anesthesia control, it is also extremely~     important to insure postoperative pain control since that is the nuisance that patients are~     most likely to complain about after oral surgery. It has been noticed that magnesium added to~     local anesthetics can improve and prolong its effect, but also reduce postoperative pain and~     accelerate recovery. It can also be used as an auxiliary to control pain and inflammation,~     which is why we will use it in this study, because we have not been able to find magnesium~     data in the literature for the removal of the lower third molars.~      Studies that have already been conducted with oral magnesium are for the purpose of~     preventing asthma, migraine, for reducing mood swings in PMS, reducing pain after~     endotracheal intubation, and many others.~      Removal by using operative procedure is the only way to remove lower third molars.~      The main objective of the study is to demonstrate the influence of the orally received~     magnesium citrate (before and after surgical removal of the lower third molar) on the quality~     and duration of the anesthetic block and also its effect on postoperative pain control. Other~     specific objectives are to investigate the effect of pre/postoperatively received magnesium~     on:~        1. swelling stage after surgery.~        2. time occurrence and duration of anesthesia.~        3. trismus stage after the operative procedure.~        4. the total amount of analgetics taken after surgery Benefits for the respondents will be~          in the assumption that the anesthetic block of the mandibular nerve will last longer~          with better quality, thus making the surgical procedure more pleasant and that the~          overall postoperative pain will be lessened and recovery faster in the magnesium citrate~          group. We also assume that in the magnesium citrate group trismus will be less~          pronounced and that swelling in postoperative days will be smaller.~   "
12871|NCT03398369|"~     This is a clinical trial of CMR guidance for the CRT procedure. Patients will be randomized~     to CMR guidance or standard care for the CRT procedure.~   "
12872|NCT03398356|"~     This study evaluates the effect of different doses of metformin on the function of~     endothelium in people with pre-diabetes. One group of the patients will receive metformin in~     dose: 1500 mg, the second one will receive 3000 mg/day.~   "
13334|NCT03392324|"~     In this early feasibility trial the safety and performance of the new retinal prothesis PRIMA~     is tested in five subjects suffering from atrophic dry age related macular degeneration.~   "
12876|NCT03398304|"~     The purpose of this study is to detail the precise temporal changes in the APR that occur in~     response to exercise in order to determine the types of exercise that confer maximal~     reparative fibrinolysis. Published research and preliminary studies conducted in our lab~     suggest that different types of exercise will preferentially activate fibrinolysis without~     changes in coagulation, thereby promoting improved global tissue health. As such, measuring~     markers of the APR in healthy individuals 1) at rest, 2) walking (light intensity exercise),~     and 3) running (moderate intensity exercise) will allow us to establish a baseline for the~     temporal changes in the APR that avoid activation of the procoagulant survival phase while~     maximizing the repair phase.~      Specific aims~        1. To measure the acute phase response fibrinolysis, plasminogen consumption, and~          inflammatory profiles of healthy individuals before and after graded exercise (at rest,~          light intensity, and medium intensity), as defined by changes in fibrinolysis,~          plasminogen consumption, and inflammatory response.~        2. To track the APR through modulated exercise in order to determine the type of exercise~          that enhances physiologic benefit and limits harm.~   "
12877|NCT03398291|"~     This study is a multi-center phase 3 trial to evaluate a treatment strategy for selecting~     patients who can benefit from the synchronous resection of primary pancreatic cancer and~     liver oligometastasis after induction chemotherapy. Half of participants who meet the entry~     criterion will receive surgical intervention, while the other half will continue to receive~     standard chemotherapy.~   "
12878|NCT03398278|"~     This is an open-label, single dose, randomised, cross-over study to confirm the~     bioequivalence (BE) of OTR tablet 40 mg and OXYCONTIN tablet 40 mg in a fasted state in~     Chinese subjects with chronic pain~   "
12879|NCT03398265|"~     The investigators will conduct a pilot randomized controlled trial (RCT) study of 100 people~     with a history of opioid use disorder releasing to WA Department of Corrections (DOC)~     community corrections supervision in King County. Half of the subjects will receive treatment~     as usual (e.g. referral to treatment or outpatient drug counseling by DOC community~     corrections staff) and half will receive 6 months of intervention. The intervention involves~     treatment decision making, in which the study interventionists help subjects understand~     treatment choices, decide on the treatment that is best for them, get enrolled in treatment~     and remain in treatment. The study does not provide treatment, but works with treatment~     providers to facilitate access to care.~      The aims of this study are to determine: 1) whether study procedures can be implemented with~     as designed, 2) whether offenders can be enrolled and maintained in the study, 3) which~     medications/treatment options subjects select and their experiences and satisfaction with the~     interventions, and 4) preliminary intervention effect size on outcomes of interest including~     recidivism, drug use, hospitalization, and treatment enrollment and retention.~   "
12880|NCT03398252|"~     Participants (N=10/group) will consist of non-treatment seeking individuals with AUD.~      Following informed consent and baseline screening, participants will partake in 3 stress~     induction sessions to assess their stress levels and cravings for alcohol. Participants will~     be randomized to receive either increasing doses of doxazosin XL (0, 4, and 8 mg) or placebo~     in a double-blind manner.~   "
12881|NCT03398239|"~     The aim of the present study; To compare the effects of respiratory support options available~     for NIMV at the emergency department; i.e. AVAPS and ST/T modes, on the patient's pCO2~     values, additional treatment need (another non-invasive ventilation method or endotracheal~     intubation) and the duration of stay in hospital.~   "
12882|NCT03398226|"~     Osteoporosis after gastrectomy, which is characterized by both the loss of bone mass and the~     deterioration of bone architecture, is a serious complication in the long course after~     gastrectomy. The aim of the present study was to evaluate osteoporosis by using~     high-resolution peripheral quantitative computed tomography (HR-pQCT) in the long course~     after gastrectomy. In total gastrectomy and distal gastrectomy groups, at least 5 years~     should have elapsed since gastrectomy.~   "
12883|NCT03398213|"~     Chronic obstructive pulmonary disease (COPD) is a major health problem. Acute exacerbations~     are a health-care burden involving frequent hospitalizations and elevated costs. They have~     effective therapies with significant side effects. Acupuncture has been shown to reduce~     dyspnea and other COPD-related symptoms. The investigators will compare the efficacy and~     safety of the addition of true acupuncture to usual care with both sham-acupressure added to~     usual care and usual care only for the treatment of acute exacerbations of COPD among~     inpatients.~   "
12884|NCT03398200|"~     Patients with Multiple Myeloma who are considered for high-dose therapy and autologous~     transplantation at the bone marrow transplant clinic at the Wilmot Cancer Institute (WCI)~     will be be approached to participate in this trial. Eligible patients who choose to~     participate will be randomized so that half receive one hyperbaric oxygen therapy session~     prior to hematopoetic stem cell infusion and half will not. All subjects will have their~     blood counts monitored closely and time to count recovery will be compared between the two~     groups.~   "
12885|NCT03398187|"~     The aim of this study is to find out and record the indications for diagnostic~     catheterization as well as for interventional cardiac catheterization in A.U.C.H , and record~     the outcome in these cases.~   "
12886|NCT03398174|"~     The main purpose of this pilot single blind randomised controlled trial is to assess the~     effects of exercise and education program on pain and functional disability in rural Nigerian~     community-dwelling individuals with chronic nonspecific LBP (CNLBP).~   "
12887|NCT03398161|"~     The goal of this clinical research study is to learn if low dose radiation therapy can help~     to control cutaneous mycosis fungoides.~      Researchers would like to learn the level of effectiveness of this lower dose of radiation~     therapy because it is likely to have fewer side effects than the standard, higher dose.~      This is an investigational study. It is investigational to treat cutaneous mycosis fungoides~     with lower doses of radiation than the standard, higher dose.~      The study doctor can describe how the radiation therapy is designed to work.~      Up to 50 participants will be enrolled in this study. All will be enrolled at MD Anderson.~   "
12888|NCT03398148|"~     The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of~     risankizumab as induction treatment in subjects with moderately to severely active ulcerative~     colitis (UC), and to identify the appropriate induction dose of risankizumab for further~     evaluation in Sub-Study 2.~      The objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared~     to placebo in inducing clinical remission in subjects with moderately to severely active UC.~   "
12889|NCT03398135|"~     The purpose of this study is to evaluate safety and efficacy of risankizumab in subjects with~     ulcerative colitis (UC) in subjects who responded to induction treatment with rizankizumab in~     a prior AbbVie study of risankizumab in UC.~      This study consists of three sub-studies: Substudy 1 is a 52-week, randomized, double-blind,~     placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory~     maintenance study; and Substudy 3 is an open-label long-term extension study for subjects who~     completed Substudy 1 or 2.~   "
12890|NCT03398122|"~     the purpose of this study is to evaluate the efficacy and safety of aptinib in patients with~     advanced HCC~   "
12891|NCT03398109|"~     the purpose of this study was to assess the efficacy of custom made toric intraocular lens~     implantation in patients with simultaneous post-DALK high corneal astigmatism and cataract.~   "
12892|NCT03398096|"~     Cardiac shock wave therapy (CSWT) is a noninvasive new therapeutic option in the treatment of~     chronic refractory angina pectoris. Many domestic and international researches have revealed~     that CSWT contributes to revascularization by stimulating angiogenesis. We were aimed to~     evaluate the safety and efficiency of CSWT in the treatment of refractory angina.~   "
12893|NCT03398083|"~     The purpose of this study is to evaluate the abuse potential of CBD to determine whether it~     should remain as a Schedule I drug under the Controlled Substances Act, or be recommended for~     decontrol.~   "
12894|NCT03398070|"~     Functional Neurological Disorder (FND/ Conversion Disorder) is a highly prevalent and~     disabling neuropsychiatric condition. Motor FND symptoms include Nonepileptic Seizures,~     Functional Movement Disorders and Functional Weakness. Clinical research across these motor~     FND subtypes, including research studies from the candidate's laboratory, suggest that these~     populations share many clinical and phenotypic similarities that warrant increased research~     integration. Furthermore, despite the prevalence of motor FND, little is known about the~     underlying neuropathophysiology of this condition, which is a prerequisite for the~     development of biologically informed prognostic and treatment response biomarkers. Across 3~     published neurobiologically focused articles, the candidate proposed a framework through~     which to conceptualize motor FND. It is suggested that motor FND develops in the context of~     structural and functional alterations in neurocircuits mediating emotion~     awareness/expression, bodily awareness, viscerosomatic processing and behavioral regulation.~     The overall goal of this project is to comprehensively investigate structural and functional~     magnetic resonance imaging (MRI) biomarkers of prognosis across motor FND. Multimodal~     structural and functional MRI techniques (including voxel-based morphometry, cortical~     thickness, resting-state functional connectivity and diffusion tensor imaging tractography)~     will be used to systemically probe brain-prognosis relationships. Novel aspects of this~     proposal include the study of the full spectrum of motor FND, consistent with a~     trans-diagnostic approach.~   "
12895|NCT03398057|"~     The purpose of this study is to assess the effectiveness of health education in improving the~     knowledge and practices of female teachers regarding screening tools and the early detection~     of breast cancer.~   "
12896|NCT03398044|"~     Adenotomy, together with tonsillectomy, belongs among the most frequently performed surgical~     procedures in paediatric patients. These surgical procedures are associated with the second~     highest incidence of post-operative nausea and vomiting (PONV) (following strabism correction~     surgery) in paediatric surgery. PONV is associated, apart from the discomfort for the child,~     with a number of complications: dehydration, metabolic disruption or danger of haemorrhage~     and aspiration of the gastric content. Adenotomy is a typologically completely different~     surgical procedure, with a different target structure of the surgery, and the length and~     invasiveness of the procedure. Thus, it is possible to expect a difference in PONV incidence~     when compared to tonsillectomy. Adenotomy is a surgical procedure performed namely in~     children of the pre-school age. This is associated, among others, also with the problem of~     objectivization of post-operative nausea, which is very difficult to verbalize in small~     children, being a subjective feeling of body discomfort. It is possible to expect that the~     overall incidence of PONV will be significantly underestimated.~   "
12897|NCT03398031|"~     Daily supplement of magnesium after biochemical diagnosis of pregnancy in females pregnant~     after ICSI and through out 1st trimester~   "
12898|NCT03398018|"~     The purpose of this pilot study is to assess repository corticotropin injection (RCI) in the~     form of H.P. Acthar Gel in patients with severe keratoconjunctivitis sicca (KCS, or dry eye~     disease). This pilot study is a non-randomized, open-label, interventional study to assess~     the efficacy and timeline of RCI for the treatment of severe KCS recalcitrant to conventional~     therapy. The purpose is to acquire preliminary data to support and guide the design of a~     future, double-masked, randomized, controlled clinical trial.~   "
12899|NCT03398005|"~     The primary objective of this study is to determine the efficacy of CaPre 4 g daily, compared~     to placebo, in lowering fasting triglyceride (TG) levels in patients with fasting TG levels~     ≥500 mg/dL and ≤1500 mg/dL (≥5.7 mmol/L and ≤17.0 mmol/L) after 12 weeks of treatment.~      Approximately 615 subjects will be screened to obtain 245 randomized subjects following a~     2.5:1 treatment allocation ratio (CaPre: placebo).~   "
12900|NCT03397992|"~     Objectives: This study is evaluating the hemodynamic effects of lowering the dialysate~     temperature in acute kidney injury (AKI) patients submitted to sustained low efficiency~     dialysis (SLED) in a single large center.~      Methods: Participants will be randomly assigned to two treatment groups. One group will be~     started treatment with low temperature (set point 5 on the machine which is around 35°C) for~     one treatment and then alternate between high and low temperatures for a maximum of 8~     treatments. The other group will be started with high temperature (set point 9 on the machine~     which is around 37°C) for the first treatment then alternate between high and low~     temperatures for a maximum of 8 treatments. Each participants will need at least two~     treatments, one with each temperature to be included in the analysis. The investigators will~     be looking for the number of events during a SLED treatment. Events will be defined as drop~     in systolic blood pressure ≥ 20 mmHg or drop in mean arterial pressure (MAP) of ≥10 mmHg,~     requirement of resuscitation with IVF after initiation of SLED, initiation or increase~     requirement of vasoactive drugs.~   "
14429|NCT03378050|"~     This is the first randomized controlled trial exploring the implementation of a~     multi-component individualized telephone-based support intervention for adult-child~     caregivers caring for parents with dementia in China. Results hold the potential to inform~     the further development of family caregiver supportive services.~   "
12901|NCT03397979|"~     There are few studies evaluating best bathing practices in the management of pediatric atopic~     dermatitis (AD). Trans-epidermal water loss plays a key role in the pathophysiology of AD. In~     concert with application of topical corticosteroids (TCS), we sought to investigate whether~     frequent soaking baths (i.e. twice daily for two weeks), followed immediately by application~     of an occlusive moisturizer (i.e. soak-and-seal), would be more effective than infrequent~     soaking baths (i.e. twice weekly for two weeks) in the management of AD.~   "
12902|NCT03397966|"~     Accumulating evidence suggests that the natriuretic peptide (NP) hormonal system has~     important effects on metabolism. However, more information is needed to better understand the~     effects of NPs on metabolism in humans. Therefore, the investigators propose a study to~     determine the effects of b-type natriuretic peptide (BNP) on energy and fat metabolism in~     humans. The investigators' primary hypothesis is that the administration of BNP will increase~     energy expenditure in humans. The investigators' secondary hypothesis is that BNP~     administration will promote changes in gene expression in fat tissue suggestive of fat~     beiging in humans. Interventions that safely increase energy expenditure and promote fat~     beiging represent potential strategies for treating metabolic dysfunction due to obesity.~   "
12903|NCT03397953|"~     The purpose of this study is to assess the efficiency and safety of vinorelbine in the~     treatment of relapsed / advanced ALCL in children and adolescents.~   "
12904|NCT03397940|"~     Summer vacation is a 3-month window of vulnerability for children from low-income households~     when health behaviors and academic learning decay. The goal of this project is to collect~     information on where low-income children go during summer, what they do when they get there,~     and how their behaviors (physical activity, sedentary, sleep, and diet) differ between the~     summer (unstructured days) and school year (structured days). This study is 1) significant~     because it will provide evidence on potential points of intervention that can reduce or~     reverse the excessive unhealthy weight gains that occur during summer and 2) innovative~     because it will be the first to identify changes in activity, sedentary, sleep, and dietary~     behaviors during prolonged and shorter periodic breaks from school and link these behaviors~     to changes in zBMI over time.~   "
12905|NCT03397927|"~     An orthosis in the ballet shoe to see if pain reduction during dancing on pointes will~     decrease.~      One group of pre-preprofessional ballet dancers will receive an orthosis and will train~     during four weeks with it. The other group without a orthosis will be the control group.~   "
12906|NCT03397914|"~     Prospective randomized study comparing different colistin dosing regimens in paediatric~     cancer patient with MDR gram-negative infection or sepsis~   "
12907|NCT03397901|"~     Refractory rectal bleeding of chronic radiation proctitis (CRP) is still problematic and does~     not respond to medical treatments including reagents, endoscopic argon plasma coagulation~     (APC) or topical formalin. We proposed this prospective cohort study, to assess the efficacy~     and safety of colostomy in treating refractory hemorrhagic CRP with moderate to severe~     anemia, to provide higher-quality evidence of colostomy in these patients.~   "
12908|NCT03397888|"~     Single center, prospective open label PK and PD study of betrixaban in subjects with mild and~     moderate hepatic impairment vs healthy volunteers.~   "
12909|NCT03397875|"~     This study will compare the effect of three different sealers on healing of teeth with apical~     periodontitis after primary root canal treatment.~   "
12910|NCT03397862|"~     A study to assess the skin irritation and sensitization potential of Corplex™ Donepezil~     Transdermal Delivery System (TDS)~   "
12911|NCT03397849|"~     In the present study, investigators aim to compare intervention using mobile technology (IMT)~     plus usual care with only usual care in patients with a high risk for cardiovascular diseases~     (CVD). Investigators hypothesize that IMT plus usual care reduces the CVD risk and improves~     the secondary outcomes in this population through 12 months of follow-up period. Patients~     presented to the outpatient clinics in a tertiary hospital (Dr. Siyami Ersek Thoracic and~     Cardiovascular Surgery Research and Training Hospital, Istanbul, Turkey) who were considered~     to be eligible according to inclusion and exclusion criteria will be enrolled to the study.~     The eligibility criteria is; Patients between 20 to 79 years old who are in high risk for CVD~     (10 years ASCVD risk ≥ 7.5%). Patients with prior CVD events (myocardial infarction,~     percutaneous coronary intervention, coronary artery by-pass grafting operation, stroke and~     peripheral artery disease), pregnancy, communication problems, severe neuropsychiatric~     problems and chronic kidney disease are excluded from the study. In addition, patients that~     are unable to use smartphone phone are also excluded.~   "
12912|NCT03397836|"~     The Health Teams Advancing Patient Experience: Strengthening Quality (Health TAPESTRY) is a~     community-based program led by primary care teams, that creates connections between trained~     community volunteers, interprofessional health care teams, novel technology and community~     engagement through improved system navigation. The overall vision is to help people stay~     healthier for longer in the places where they live.~   "
12913|NCT03397823|"~     Head and neck cancer represent 4-5% of all of cancer diagnosed in the UK, the first choice of~     treatment it is Radiotherapy (RT). RT is known to produce a wide range of oral side effects~     such as hypo-salivation, caries, xerostomia, mucositis and osteoradionecrosis.~      Hypo-salivation may lead to a shift in diversity of the bacterial population altering oral~     homeostasis. RT may also cause a variation in saliva protein composition which can affect its~     rheological properties and host defence increasing the possibility of caries development.~     Additionally, the effects of RT on the organic and inorganic structure/ composition of teeth~     and the possible relation with caries risk have not been investigated so far.~      Mucositis is another frequent oral complication of RT and it is estimated that more than 80%~     of the treated patients will develop this condition.~      Longitudinal studies assessing all these conditions before and after cancer treatment have~     not been reported in literature to date.~      Therefore, the main objective of the proposed study is to assess the chemical composition of~     the dentine matrix, the variations in salivary proteins and in oral microbiome occurring in~     Head & Neck cancer patients undergoing RT. These data will be collected and a complete oral~     assessment with 18 month follow up will be performed. All these data will be computed to~     demonstrate the associations between RT and caries risk to demonstrate possible mechanistic~     causes.~   "
14442|NCT03377881|"~     STHLM3-MR Phase 2 is a study comparing traditional prostate cancer detection using PSA and~     systematic biopsies with the improved pipeline for prostate cancer detection using the STHLM3~     test and targeted biopsies in a screening context.~   "
12914|NCT03397810|"~     Cardiac amyloidosis is responsible for significant morbidity associated with heart failure,~     and carries a poor prognosis. Currently there are very limited treatment options for this~     condition. Radiotherapy has been used successfully to treat amyloidosis elsewhere in the~     body, however has not been trialled in cardiac amyloidosis. Therefore this study aims to~     assess the effect of radiotherapy on cardiac amyloidosis, to evaluate whether it can~     successfully reduce the burden of amyloid deposits in the myocardium as assessed by~     18F-Amyloid PET.~   "
12915|NCT03397797|"~     Investigators assess and compare postoperative sore throat and hoarseness in the group using~     the muscle relaxant and not using it during the operation.~   "
12916|NCT03397784|"~     The purpose of the study was to evaluate the efficacy of using the respiratory variation in~     inferior vena cava diameters as an index of fluid responsiveness after tidal volume challenge~     in mechanically ventilated patients after cardiac surgery.~   "
12917|NCT03397771|"~     This study will explore the safety, tolerability and efficacy of litoxetine in men and women~     who suffer from urinary incontinence~   "
12918|NCT03397758|"~     The investigators treated twenty-four subjects with lower eyelid fat bulging using the needle~     radiofrequency system. After treatment, a three-dimensional photogrammetry system was used to~     objectively measure the change in height of the fat bulge.~   "
12919|NCT03397745|"~     The investigators try to conduct a study to assess the impact of changing patients' lateral~     decubitus position on BIS readings during esophageal cancer operation. Also, the~     investigators evaluate the effects of one-lung ventilation and total lung ventilation on BIS~     value with inhalation agent.~   "
12920|NCT03397732|"~     The MMP-9-TIMP-1 system has been implicated in many physiological and pathophysiological~     conditions including vascular surgery related ischemic-reperfusion injury. Our key aims were~     to establish the early perioperative time courses of the aforementioned system in~     aorto-bifemoral bypass and aorta stentgraft implantation procedures and to find correlation~     between the MMP-9-TIMP-1 system and the cross-clamp time. Patients were prospectively~     enrolled after Ethical Committee approval. Blood samples were taken at four different time~     points (T1-4): T1: right before surgery, T2: 60 min after the cross-clamp release, T3: first~     postoperative morning, T4: third postoperative morning. Plasma was isolated from heparin~     anticoagulated blood samples by low speed centrifugation at 4 °C, and stored at -80 °C until~     analyzed in a single batch at the end of the study. MMP- 9 and TIMP-1 were determined by the~     quantitative sandwich enzyme-linked immunosorbent assay (ELISA) techniques according to the~     manufacturer instructions (R&D Systems Inc., Minneapolis, Minnesota, USA). In comparison with~     standard curves, the concentrations of MMP-9 and TIMP-1 in plasma were determined~     spectrophotometrically (Multiskan Ascent microplate photometer, Type: 354, Thermo Electron~     Corporation, Waltham, Massachusetts, USA) by reading the absorbance at 450 nm. Plasma~     concentrations of MMP-9 and TIMP-1 were expressed as ng/ml.~   "
12921|NCT03397719|"~     The purpose of this study is to use a randomized controlled trial to test the effectiveness~     of parent coaching sessions using video-based feedback, compared to the sessions without the~     use of video-based feedback on parent strategy use.~   "
12922|NCT03397706|"~     A two part, Phase 1b/2 study to define a recommended Phase 2 dose of VRx-3996 in combination~     with valganciclovir (Phase 1b) designed to evaluate the efficacy of this combination in~     relapsed/refractory EBV+ lymphomas.~   "
12923|NCT03397693|"~     Evaluation of the endometrial thickness and subendometrial blood perfusion in women with~     unexplained infertility and PCOS using 3D Power Doppler and uterine artery Doppler in~     comparison to a control group.~   "
12924|NCT03397680|"~     H.pylori is an organism which causes gastric inflammation, peptic ulcer disease (PUD), mucosa~     associated lymphoid tissue (MALT) lymphoma and gastric cancer.~      Practical guideline for treatment of patients with dyspepsia and H.pylori eradication~     recommended the 14-day triple therapy regimen which had curable about 70% by using proton~     pump inhibitor (PPI) combined with antibiotics including amoxicillin, clarithromycin and~     metronidazole.~      Up to date, there has been no evidence about the cure rate for H.pylori eradication with~     once-daily dose regimen of high dose rabeprazole and levofloxacin based therapy. This~     research is to study the 7-day and 14-day cure rate of H.pylori eradication treatment with~     once-daily regimen of high dose rabeprazole-levofloxacin based quadruple therapy.~   "
12925|NCT03397667|"~     This study will test the effectiveness of an intervention for Veterans diagnosed with~     Alzheimer's Disease (AD) or Traumatic Brain Injury (TBI) and the burden on their informal~     (family/friend) caregiver.~   "
12926|NCT03397654|"~     Open label, single arm, multi-centre study of pembrolizumab following trans-arterial~     chemoembolization (TACE). Twenty-six to 32 evaluable participants with primary liver cancer~     (hepatocellular cancer; HCC) will be assessed. The primary objective is to determine the~     safety and tolerability of pembrolizumab following TACE. The secondary objective is to~     evaluate the efficacy of pembrolizumab following TACE by improving progression-free survival~     rates as measured by modified response evaluation criteria in solid tumours (mRECIST)~     criteria.~   "
12927|NCT03397641|"~     This is a Phase 1 randomised, double-blind, placebo-controlled, serial cohort,~     dose-escalation study in healthy adult volunteers. It is planned to enroll 5 cohorts (Cohorts~     A to E) of 8 subjects. Up to 2 additional cohorts (Cohorts F and G) may be enrolled as needed~     to establish the safety profile of HBI-3000 over a clinically relevant range of doses.~     Subjects will be randomly assigned to receive a single dose of HBI-3000 or matching placebo~     in a sequential escalating manner (Regimens A to E and optional Regimens F and G), with a~     minimum of 7 days and a maximum based on logistics of interim review between dose groups.~      As a safety precaution, in each cohort a sentinel dosing group of n = 2 (1 active:1 placebo)~     will be dosed at least 24 h ahead of the main group. Safety and tolerability will be assessed~     by the principal investigator or medically-qualified designee before continuing with dosing~     the remaining subjects. The first 2 subjects will be allocated to active or placebo in a 1:1~     ratio. The remaining 6 subjects will be allocated to active or placebo in a 5:1 ratio.~      Doses of HBI-3000 may range from 20 mg to a level at which it is expected that the drug~     exposure will not exceed an AUC(0-t) of 20 μg.h/mL and Cmax of 20 μg/mL (based on the~     no-observed-adverse-effect levels [NOAEL] in both 14 day repeat dose toxicology species the~     rat and minipig) and the expected therapeutic dose range. Following administration to each~     cohort, there will be an interim data review during which the PK and safety data will be~     reviewed to determine the dose to be administered in the next cohort. Dose escalation for~     serial cohorts will progress unless safety concerns preclude further dose escalation. If the~     selected dose does not provide the required data, a previously tested dose may be used in a~     subsequent cohort. However, if the dose level met the dose escalation stopping criteria, that~     dose level must not be repeated. A previously untested intermediate dose may also be used in~     a subsequent cohort.~   "
16318|NCT03353363|"~     Randomized double blind placebo controlled trial to compare the post-operative pain control~     advantages of post-incisional wound infiltration with liposomal bupivacaine to plain~     bupivacaine in patients presenting for elective caesarean delivery.~   "
12928|NCT03397628|"~     Proposed action: To investigate the effect of an innovative and easily implementable~     football-based health education programme on well-being, self-esteem, health knowledge and~     physical fitness for 10-12-year old school children. The programme has been running in 22~     countries in Africa and South America and is now being adapted to the Western World. The~     first step was to run a pilot implementation for more than 600 school children in Copenhagen,~     Frederiksberg, Roskilde and Frederikssund in the school year 2015-2016. From august 2016 to a~     nationwide implementation for 30,000 school children is started in Denmark and The Faroe~     Islands.~   "
12929|NCT03397615|"~     The present study was a prospective randomized controlled trial in which subjects received a~     vaginal preparation with povidone-iodine solution immediately prior to caesarean delivery or~     received no vaginal preparation~   "
12930|NCT03397602|"~     The main purpose of this project is to evaluate the effects of high-intensity interval~     training (HIIT) compared to moderate-intensity continuous exercise training (MICE) and~     standard care on exercise capacity and quality of life in patients with persistent or~     permanent atrial fibrillation. Positive findings are vitally important for these patients,~     given the condition's substantial morbidity, mortality and high economic costs.~   "
12931|NCT03397589|"~     This study assesses the impact of oral health promotion delivered by community health workers~     in medical clinics, Women, Infants and Children (WIC) centers, and family homes.~     Investigators will assess oral health behaviors in children aged 0 to 3.~   "
12932|NCT03397576|"~     Adherence to antiretroviral therapy (ART) drops sharply after prison release. Effective~     medication adherence training immediately before and after prison release may improve health~     outcomes and limit transmission of Human Immunodeficiency Virus (HIV). ATHENA (Adherence~     Through Home Education and Nursing Assessment) is an evidence-based medication adherence~     intervention, which is delivered in the patient's home by nurses and peer educators working~     in teams. In this study, researchers will examine the acceptability and feasibility of the~     ATHENA intervention through a 2-arm randomized controlled trial conducted with HIV-infected~     prisoners in Indonesia. Eligible subjects will be >18 years of age, HIV-infected, and may be~     treatment-experienced or treatment-naive. Subjects randomized to the intervention arm will~     participate in monthly medication adherence counseling sessions within prison and home visits~     up to four months after prison release. Subjects randomized to the control arm will receive~     standard care, which includes a referral for HIV care after prison release. The primary~     endpoint is the proportion of subjects demonstrating ART adherence >90% at 3 months after~     prison release. Secondary endpoints are: 1) retention in HIV care, 2) ART initiation, 3) HIV-~     RNA viral load, 4) CD4+ T-cell count, 5) quality of life, 6) hospitalization, 6) substance~     use and sexual risk behaviors at 3 months after prison release.~   "
12933|NCT03397563|"~     Cluster headache is also called suicide headache due to excruciating nocturnal attacks. There~     are few treatment options available. Inhalation of oxygen has shown to abort the attacks.~      Continuous positive airway pressure (CPAP) is a machine used during sleep to treat~     respiratory failure. Automatic CPAP machines adjust the air pressure through the night to~     keep the upper airways patent.~      Single reports have shown a high prevalence of obstructive sleep apnea in people suffering~     from cluster headache, and positive effects of CPAP treatment, but no randomized controlled~     trial has been conducted so far.~      If proven effective CPAP would make an affordable treatment option for many patients within~     the existing healthcare system.~   "
12934|NCT03397550|"~     The compliance of salt restriction in patients with CKD may be associated with taste~     sensitivity.~   "
12935|NCT03397537|"~     The study aimed to compare the duration to complete or partial response (CR/PR) and the~     overall response rates (ORR) after six months of neoadjuvant endocrine therapy between~     pre-menopausal group and post-menopausal group with highly endocrine responsive operable~     mammary carcinoma.~   "
12936|NCT03397524|"~     ARTERY is a randomized clinical trial that investigates the benefit of a predictive modeling~     artificial intelligence in improving the management of anti-hypertensive medication~     treatment.~   "
12937|NCT03397511|"~     Financial incentives for motivating health change have been increasingly employed in various~     healthcare sectors. They can be a potentially effective approach to promote smoking~     behavioral change and increase the use of evidence-based counseling and pharmacotherapy.~     Smoking cessation randomized clinical trials (RCT) incorporating financial incentives have~     been conducted in different populations; however, there has not been a randomized clinical~     trial coupled with a financial incentive with Asian American cigarette smokers. The purpose~     of this pilot study is to examine the feasibility of implementing an incentivized smoking~     cessation program among Asian American smokers in New York City.~   "
12938|NCT03397498|"~     Little is known about preventive strategies with immediate public health impact for cognitive~     functioning in the oldest-old (OO). Cognitive training improves cognitive functioning in the~     young-old (YO; 60 to 84), yet has not been examined in the OO.~      Clinical trials are needed to determine if computerized cognitive training is effective at~     preventing or delaying cognitive decline in the OO. In order to develop such trials,~     information regarding use of computers and internet by the OO, and the ability and interest~     in such a program, must be determined.~      This study will examine the effects of a computerized cognitive training program, CogniFit™,~     with a classic computerized games program, on cognitive functioning in cognitively healthy~     OO subjects. Information regarding use of computers and internet by the OO will be collected.~     Interest in and ability to complete a computerized cognitive training program will be~     examined, along with the cognitive, demographic, biological, and lifestyle characteristics~     related to this interest and ability.~      Efficacy of the CogniFit™ and games programs will be assessed immediately following the~     training and four months after completing the training. The researchers expect that those who~     use the CogniFit™ program will have greater improvements than those using the games program.~     Finally, the participants' characteristics related to the efficacy of the programs will be~     examined.~      Subjects recruited for this project will include those already participating in several~     studies of aging and cognition at the Mount Sinai School of Medicine. Recruiting from this~     pool of subjects will provide this program with baseline information regarding numerous~     subject characteristics, including cognition, family history, lifestyle, and cardiovascular~     information.~      This study will inform future large-scale clinical trials of computerized cognitive training~     programs in the elderly, as well as provide information regarding the efficacy of such~     training in the OO. In addition, the study will identify characteristics affecting efficacy~     of computerized training, and thus, may suggest mechanisms through which cognitive training~     improves cognitive functioning in the most senior citizens of our society.~   "
12949|NCT03397355|"~     In the past few years, circulating tumor cells (CTCs), circulating tumor DNA (ctDNA),~     microRNAs, autoantibodies, and T-cell receptor repertoire are new biomarkers of liquid biopsy~     in cancer, which has been demonstrated to have a great value in diagnostics, treatment~     evaluation, and prognosis prediction. However, most of previous data were based on late stage~     tumor patients. This study plans to utilize the minimally invasive method to detect the~     changes of numbers of CTCs, ctDNA hot spot mutations and methylation signals, microRNAs,~     autoantibodies, and T-cell receptor repertoire in early stage lung cancer patients before and~     after pulmonary nodule biopsy, during therapeutic and follow-up periods, in order to evaluate~     the clinical values of above tumor-related biomarkers.~   "
12939|NCT03397485|"~     The objective of the present study was to assess the effect of a growing-up milk on growth~     and micronutrient status in children 12 to 30 months of age.~      The study was conducted in Cuernavaca, the state capital of Morelos, Mexico. The~     investigators included children who attended day-care centers. These day- care centers are~     part of a national government program which main objective is to support working mothers and~     those who intend to work and do not have access to a health service and are at risk of~     poverty. The study described herein is a randomized, parallel, double-blind, controlled trial~     by administration of growing up milk (GM) and fortified milk (FM).~      Results showed a significant improvement in linear growth in both supplemented groups, with~     no statistical difference between treatments. By using an artificial, population-based~     comparison group, the investigators conclude that this improvement was attributable to the~     supplements.~   "
12940|NCT03397472|"~     This observational study was designed to explore the clinical effect of magnetic field~     modulation system on insomnia patients and provide a new solution for insomnia treatment.~   "
12941|NCT03397459|"~     The aim of this observational study is to establish estimation of global lordosis of the~     cervical spine (from C3 to C7) in patients with cervicobrachial neuralgia.~   "
12942|NCT03397446|"~     The relatively high rates of bulimia nervosa (BN) in attention-deficit/hyperactivity disorder~     (ADHD) cohorts suggest a relationship between the two disorders. Interestingly, case studies~     involving this comorbid population have observed improvements in BN symptoms when given~     psychostimulants for ADHD. Case studies involving BN patents without this comorbidity have~     also demonstrated BN symptom improvements upon psychostimulant initiation. Recent studies~     have also found support for the use of lisdexamfetamine dimesylate, a psychostimulant~     approved for ADHD, for treating moderate to severe binge eating disorder, an eating disorder~     akin to BN. Given these findings, there is reason to believe that psychostimulants may also~     be capable of treating bulimia nervosa.~      Ultimately, the investigators would like to conduct a large study that examines whether~     people who are diagnosed with BN will have fewer episodes of binge eating and purging when~     they are treated with the psychostimulant medication, lisdexamfetamine dimesylate (LDX).~     However, preliminary data would be helpful prior to undertaking such a large project. To this~     end, the aim of the current study is to learn more about a) enrolment rates, b) dropout~     rates, c) the applicability of our eligibility criteria, d) the potential effects of LDX on~     novel outcome measures for studying decision-making in BN, e) preliminary safety data, and f)~     estimates of treatment effect.~      Participants (n = 30) will be instructed to take LDX once daily for two months while~     undergoing routine testing and monitoring to gather preliminary safety and treatment data.~     The research will take place at the Nova Scotia Health Authority Eating Disorder Clinic.~   "
12943|NCT03397433|"~     Beginning in the mid-to late 1980s and accelerating through the 1990s and 2000s the shield of~     antibiotic invincibility began to crack sufficiently so that it was apparent to everyone we~     faced a serious problem. The investigators will demonstrate and expand the use of information~     technology based on the ingenious weighted-incidence, syndromic, combination antibiogram~     (WISCA) tool for the widespread use of automated clinician prompts enhancing empiric~     antibiotic therapy as part of a comprehensive infection control stewardship program that~     reduces antibiotic resistance. This research program will demonstrate that use of such a tool~     lowers mortality, improves outcome, lowers antimicrobial resistance and reduces healthcare~     cost.~   "
12944|NCT03397420|"~     The study will evaluate the effect of implementing a family-centered care (FAM-CARE) program~     (where all HIV-positive family members are seen together as a unit and receive care together)~     on viral suppression and retention in HIV-positive children <15 years through enrollment of a~     prospective cohort of 660 HIV-positive children and their caregivers at sites that were~     randomized to either implement the family-care program (intervention sites) or continue the~     current standard of care (control sites).~   "
12945|NCT03397407|"~     Adiposity is a key link between lifestyle factors (like diet and exercise) and cardiovascular~     (CV) disease. However, little is known about the link during the juvenile years, when the~     processes leading to CV disease are at an early stage of development. The specific aims are~     as follow: (1) to determine the relations of free-living diet and exercise to total body~     percent fat ( percentBF), visceral adipose tissue and CV fitness in black and white boys and~     girls of varying socioeconomic status. (2) to determine the relations of fatness and fitness~     to different CV disease risk factors. Design and methods: (1) Recruit 800 14 to 18 year olds,~     200 in each ethnicity and gender subgroup. (2) Assess diet with seven 24-hour recalls, and~     exercise with two seven-day recalls and heart rate monitoring. (3) Measure percent body fat~     with dual-energy x-ray absorptiometry, visceral adipose tissue with magnetic resonance~     imaging and CV fitness with a multi-stage treadmill test. (4) Measure major fatness- and~     fitness-related CV disease risk factors (e.g., total cholesterol:HDL cholesterol ratio,~     insulin, systolic blood pressure, left ventricular mass indexed to height, fibrinogen). (5)~     Conduct multivariate and univariate analyses to determine relationships.~   "
12946|NCT03397394|"~     The purpose of the ATLAS study is to determine how patients with locally advanced or~     metastatic urothelial carcinoma respond to treatment with rucaparib.~   "
12947|NCT03397381|"~     identification of the factors that affect the outcome of arteriovenous fistula in chronic~     renal failure patients that newly established regular dialysis in Assiut Governorate~        1. To study the factors that influence the outcome of AVF~        2. To evaluate the vascular complications of AVF as occlusion, rupture, aneurysmal dilation~          and hand ischemia~   "
12948|NCT03397368|"~     Stress urinary incontinence (SUI) has an observed prevalence of between 4%and 35%.Identified~     risk factors are aging, obesity and repeated pregnancies and deliveries.~      Urodynamic remains the gold standard for diagnosis in the past years. Trans labial ultrasound~     appears to have a good role in diagnosing stress incontinence~   "
12966|NCT03397134|"~     MIN-101C07 is a multicenter, multinational, randomized, double-blind, placebo-controlled,~     parallel-group study to evaluate the efficacy and safety of MIN-101 in adult schizophrenia~     patients.The primary objective is to evaluate the efficacy of 2 fixed doses of MIN-101~     compared to placebo in improving the negative symptoms of schizophrenia over 12 weeks of~     double-blind treatment as measured by the change in Positive and Negative Syndrome Scale~     (PANSS) Marder negative symptoms factor score (NSFS) over 12 weeks.~   "
12950|NCT03397342|"~     The goal of this imaging study is to evaluate and improve the treatment planning techniques~     for abdominal radiation therapy. To accurately treat a tumor with radiation, Computed~     Tomography (CT) and Magnetic Resonance Images (MRI) are used to distinguish a tumor from~     normal, healthy tissue. However the quality of these images can be distorted by motion from~     breathing. To decrease motion, a patient may be asked to hold their breath or compress the~     abdomen, but currently there is no standard or best management option for all patients.~      This study will explore the use continuous positive airway pressure (CPAP), a pressurized~     breathing mask, during MRI or CT imaging to decrease motion in the abdomen and produce higher~     quality images. With these additional images, we will also explore the feasibility of~     creating treatment plans using the CPAP MRI images alone.~   "
12951|NCT03397329|"~     The purpose of this Phase 1, randomized, open-label, two-period crossover study is to~     characterize and compare the pharmacokinetic (PK) profiles and evaluate the safety of the~     AG-348 tablet and capsule formulations after single-dose administration in healthy adult~     subjects. Pharmacokinetic sampling will take place serially at specified times during conduct~     of the study.~   "
12952|NCT03397316|"~     Marginal bone loss in immediate implant placement in upper esthetic zone by comparing between~     non grafting in immediate implant placement with xenograft placement in other side.~      the study is to assess the marginal bone loss in the two techniques and compare results~     between them.~   "
12953|NCT03397303|"~     This project aims to understand how nerve mechanical properties are altered in patients with~     rare peripheral neuropathies . Stiffness of various peripheral nerves will be measured using~     ultrasound shear wave elastography. Patients will be compared with age-matched controls.~   "
12954|NCT03397290|"~     Currently chest X-ray (CXR) is the modality used to assess for pneumothorax after~     transthoracic lung biopsy at the Ottawa Hospital. Recently bedside Ultrasound (US) has become~     a useful rapid imaging modality to assess chest for pneumothorax in emergency rooms with~     reported sensitivity, specificity and diagnostic accuracy were 88%, 97% and 97%, respectively~     (ref. 2).~      Our team will be comparing the diagnostic accuracy of US to CXR in diagnoses of pneumothorax~     post transthoracic lung biopsy.~      The purpose of the study is to compare the diagnostic accuracy of US to CXR post-biopsy to~     confirm the presence of a pneumothorax.~   "
12955|NCT03397277|"~     This study investigates the effect of a video which teaches 15 safety behaviours for women~     subject to intimate partner violence (IPV) during pregnancy. Half of the women screening~     positive for IPV during pregnancy will view the intervention video. The other half will view~     a control video.~   "
12956|NCT03397264|"~     A two part, multi-center study consisting of a Phase 1b open label, sequential dose~     escalation followed by a Phase 2a randomized, double-masked, dose expansion evaluating~     OPT-302 in combination with aflibercept in participants with persistent central-involved~     Diabetic Macular Edema.~   "
12957|NCT03397251|"~     This study is for participants who have been diagnosed with an acute aortic~     dissection/intramural hematoma (also known as a DeBakey I or Stanford type A dissection/~     intramural hematoma). In a healthy aorta (the vessel that supplies blood to most of the body)~     the blood flows freely through the main lumen (a space inside the vessel where blood flows).~     The participants involved in this study have a tear that has separated the inner layer of the~     aorta wall and created a secondary channel (false lumen) in addition to the main channel~     (true lumen). The blood is now flowing through both channels.~   "
12958|NCT03397238|"~     This study investigates the reprogramming of myeloid cells in patients with thyroid~     carcinoma. The investigators hypothesize that tumor-derived factors change the function of~     myeloid cells in such a way that these immune cells promote tumor growth rather than combat~     the tumor.~   "
12959|NCT03397225|"~     This was an unblinded, randomised controlled study, the purpose of which was to investigate~     the impact of a structured health education intervention on the glycaemic control of Type 2~     diabetes patients within a Kuwaiti cultural context.~   "
12960|NCT03397212|"~     This project aims at examining the following hypotheses:~        -  Treatment with NADA and clonidine reduces intensity of withdrawal symptoms to a greater~          extent than treatment with clonidine.~        -  Opioid withdrawal improves pain, physical and mental functioning and reduces opioid~          consumption 3 months and 1 year after withdrawal.~   "
12961|NCT03397199|"~     The purpose of this study is to confirm the safety and efficacy of Apatinib plus S-1 as the~     Therapy of Advanced Colorectal Cancer.~   "
12962|NCT03397186|"~     This research trial studies the immune changes following trabectedin in patients with sarcoma~     that has spread to other places in the body or cannot be removed by surgery. Analyzing tumor~     tissue may help to understand the changes in immune cells in or around the tumor or if there~     is an increase in immune cells in the tumor after receiving trabectedin.~   "
12963|NCT03397173|"~     The purpose of this study is to evaluate the efficacy of treatment with azacitidine (an FDA~     approved drug for the treatment of MDS) and high dose ascorbic acid in patients with TET2~     mutations. This approach is intended to enhance the enzymatic activity of TET2 protein, which~     in term may help to improve counts and symptoms, related to Myelodysplastic Syndromes and~     Acute Myeloid Leukemia. This combination is specific to individuals who carry this mutation.~   "
12964|NCT03397160|"~     This clinical trial evaluates the use of novel decision support educational materials and~     services using health coaches. The study includes men newly diagnosed with low-risk prostate~     cancer. A 160 men will be recruited. Half of the men will receive a call from a health coach~     before their initial consultation visit with their urologist to review their treatment~     concerns and questions. The other half will receive usual care provided by the urologist,~     such as educational materials and services provided by the urologist.~   "
12965|NCT03397147|"~     Evaluate the feasibility, acceptability, and preliminary efficacy of a sleep-promoting~     intervention for school-aged children with type 1 diabetes and their caregivers in a pilot~     randomized trial. The primary outcome is improvements in child sleep, and secondary outcomes~     include glycemic control (HbA1c, % in range), improvements in parent sleep, parental~     distress, and child behavior problems.~   "
12967|NCT03397121|"~     This is a Phase III, placebo-controlled, double-blind, randomized study in participants with~     HeFH and elevated LDL-C to evaluate the efficacy, safety, and tolerability of subcutaneous~     (SC) injection(s) of inclisiran. The study will be multicenter and international.~   "
12968|NCT03397108|"~     Breastfeeding is beneficial to both mother and baby. However, many breastfeeding women are~     affected by long-term health conditions and need to take medications. Sometimes, concerns~     about transfer of drugs to infants via breast milk lead the mothers to either avoid~     breastfeeding or stop their medication.~      Inflammatory Bowel Disease (IBD) is a chronic condition that is marked by an abnormal~     response of the body's immune system, and high levels of certain proteins that cause~     inflammation (Cytokines like Tumor Necrosis Factor-alpha or TNFα). A group of drugs called~     biologics target and stop these proteins from causing inflammation, and have been~     successfully used to treat this condition. Inflammatory proteins may be present in breast~     milk of healthy women in variable levels, and may play a role in development of infant's~     brain and immune system.~      This study is being conducted to investigate:~        -  Concentration of some of the inflammatory proteins in breast milk of mothers with IBD~          and healthy controls~        -  Interaction between these proteins and biologics in breast milk of women with IBD~        -  Potential role of these proteins (and their interaction with biologics) on development~          of infant learning and memory function It has been presumed that concentrations of TNFα~          and some other cytokines are higher in breast milk of women with IBD, and the biologics~          can normalize these high levels.~      The study consists of four study visits: a) two home visits in the first 6 months postpartum~     to complete a questionnaire and collect a small sample of breast milk at each visit and b)~     two visits at the Hospital for Sick children for evaluation of learning and memory function~     of the infant at the ages of 12 and 18 months.~   "
12969|NCT03397095|"~     This study is designed to evaluate the efficacy, safety and tolerability of autologous bone~     marrow derived mesenchymal stem cells compared to placebo (sham operation) when administered~     via percutaneous coronary infusion to patients with ischemic heart failure, who are screened~     by D-SPECT and have pretreated with 3-month cardiac shock wave therapy.~   "
12970|NCT03397082|"~     To compare the effectiveness of lidocaine gel plus paracervical blockade vs. Paracervical~     blockade alone in the management of pain during endouterine manual aspiration.~   "
12971|NCT03397069|"~     Regional eye blocks are usually preferred for ophthalmic procedures. Peribulbar block (PBB)~     is a safe alternative for patients undergoing cataract surgery. Many studies tried to solve~     this issue by means of prolonging the duration of action of the local anesthetics used.~     Several drugs were tried as adjuncts to local anesthetics, and their effects have been~     studied. Midazolam added to the list of adjuvant used in the subarachnoid or epidural block~     can produce analgesia, probably mediated by the benzodiazepine-Gamma Amino-Butyric Acid(GABA)~     receptor complex.~      The investigators hypothesized that the addition of midazolam to lidocaine will improve the~     quality of the peribulbar block; fasten the onset and prolonging its anesthetic and analgesic~     duration.~   "
12972|NCT03397056|"~     The primary objective of this study is to determine how biomedical research is perceived by~     patients already participating in a pulmonology research project.~   "
12973|NCT03397043|"~     In this study, the investigators will use the minimally invasive indicator amino acid~     oxidation (IAAO) technique to determine protein requirements in weight-trained males. It is~     hypothesized that the present study will show that protein requirements for weight-trained~     females are i) greater than the current RDA for non-active individual's comparable estimates,~     and ii) greater than existing nitrogen balance-based estimates for weight-training~     individuals~   "
12974|NCT03397030|"~     The goal of this study is to demonstrate the impact of a home based exercise program versus~     wait-list control to modulate circulating prognostic biomarkers in men with prostate cancer~     under active surveillance.~   "
12975|NCT03397017|"~     The National Transfusion Treatment Survey in patients with sickle cell disease (SCD) is a~     prospective longitudinal systemic study that was created in order to evaluate the therapeutic~     approach, mainly transfusional, in patients affected by SCD throughout Italy and to improve~     the quality of care and implement research.~      The survey will evaluate all patients affected by different forms of sickle cell disease (HbS~     homozygosis, Thalassoso-drepanocytosis, HbS / HbC compound heterozygosis, other possible~     genetic compounds).~      Patients will be selected according with a SCD diagnosis confirmed by standardized~     biochemical criteria or by DNA analysis. Patients will be excluded from the study who do not~     meet the these requirements, who are unable to understand the protocol or able to give~     informed consent in the absence of any legal representative.~      All data will be collected through a standard web-based application, which will be completed~     by the responsable investigator or by sub-investigators selected by each center, after~     registration on the site providing personal data and indicating the affiliation structure.~     All data will be subsequently encrypted by the Central Server. The operator will subsequently~     be able to access the patient's clinical data to perform the updates, in order to follow the~     patient's clinical evolution over time. The study will not involve any additional tests~     compared to the routine of patient control.~   "
12976|NCT03397004|"~     This study will investigate the effectiveness of oral doxycycline for the treatment of~     recurrent nasal hemorrhage in Hereditary Hemorrhagic Telangiectasia (HHT) subjects. The~     primary outcome for the trials will be the reduction of epistaxis severity (minutes of~     bleeding per week). The biological outcomes of interest are the regression of vascular~     malformations as well as tissue and circulation biomarkers of the relevant mechanistic~     pathways. A Phase II, randomized double-blind placebo-controlled crossover trial.~     Approximately 30 subjects with HHT, with moderate-severe recurrent epistaxis will participate~     in the randomized double-blind placebo-controlled cross over trial. Subject will be treated~     with a 6-month course of doxycycline 100mg twice daily or placebo twice daily.~   "
12977|NCT03396991|"~     Background: Recent studies showed the efficiency of several techniques of anesthesia in foot~     surgery. The new mini-invasive surgical approaches should require less analgesia and rapid~     motor recovery after surgery. The aim of this study was the evaluation of two different~     techniques on postoperative analgesia and motor recovery after hallux valgus correction in~     one-day surgery patients.~   "
13018|NCT03396445|"~     The purpose of this study is to assess the safety and pharmacokinetics of MK-5890 when~     administered alone and in combination with pembrolizumab (MK-3475) in adults with advanced~     solid tumors. The initial course of MK-5890 monotherapy or MK-5890 plus pembrolizumab~     combination therapy will be for up to 35 administrations (approximately 2 years).~   "
12978|NCT03396978|"~     This research study plans to learn more about the role of female sex hormones on adipose~     tissue (or fat) and the gut microbiome (or the organisms that are in your digestive tract).~     The rationale for this study is that the rate at which women gain fat (especially in the~     stomach region) increases after menopause. It is thought to be due to the loss of estrogen~     because post-menopausal women who take estrogen gain less weight than those who do not take~     estrogen. Gut bacteria process estrogen and help determine the types of estrogen that~     circulate in the body. These bacteria can be changed with lifestyle factors such as diet, and~     may therefore, also affect the risk of diseases that are more common in women after menopause~     i.e., cardiovascular disease and cancer. In this study the investigators will obtain fat~     biopsies before and after 6 months of ovarian hormone suppression to measure how the fat~     cells change with the loss of female sex hormones (e.g., medical menopause). The~     investigators will also obtain stool and urine samples before and every month during the~     study to measure changes in the microbiome.~   "
12979|NCT03396965|"~     Determine efficacy of the use of mini-c-arm fluoroscopy for the closed reduction of isolated~     distal radius fractures in adult patients in the emergency department setting.~   "
12980|NCT03396952|"~     This phase II trial studies how well pembrolizumab, ipilimumab, and aspirin work in treating~     patients with melanoma that has spread to other places in the body or cannot be removed by~     surgery. Monoclonal antibodies, such as pembrolizumab and ipilimumab, may interfere with the~     ability of tumor cells to grow and spread. Aspirin may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Giving pembrolizumab, ipilimumab, and~     aspirin may work better in treating patients with melanoma.~   "
12981|NCT03396939|"~     The interventional study aims to increase the knowledge on arm and hand rehabilitation after~     stroke within community-based services. The primary objective of the study is to evaluate the~     feasibility and clinical usefulness of the arm and hand training program (focusing on~     functional goal- and task-oriented daily life exercises) in combination with the use of an~     orthotic device in terms of patient compliance and improvement of outcomes. The secondary~     objective is to compare the effectiveness of the program with or without the use of an~     orthotic device in a randomized controlled trial.~   "
12982|NCT03396926|"~     This phase II trial studies the side effects and best dose of capecitabine when given~     together with pembrolizumab and bevacizumab, and to see how well they work in treating~     patients with microsatellite stable colorectal cancer that has spread to nearby tissues or~     lymph nodes, has spread to other places in the body, or that cannot be removed by surgery.~     Monoclonal antibodies, such as pembrolizumab and bevacizumab, may interfere with the ability~     of tumor cells to grow and spread. Drugs used in chemotherapy, such as capecitabine, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Giving capecitabine together with~     pembrolizumab and bevacizumab may work better in treating patients with colorectal cancer.~   "
12983|NCT03396913|"~     The aim of the current study is to examine the contribution of intense pulsed light (IPL) for~     relieving signs and symptoms of dry eye due to meibomian gland dysfunction. The effect of IPL~     will be examined in a study designed as a randomized controlled trial. In the study arm,~     subjects will undergo 4 treatment sessions, consisting of IPL pulses immediately followed by~     meibomian gland expression (MGX). In the control arm, subjects will undergo the same~     treatments, except that the IPL pulses will be disabled. For each subject, the duration of~     the study will be 10 weeks, as explained in the detailed description.~   "
12984|NCT03396900|"~     rhBMP-2 has the potential to function as a regenerative material in periodontally accelerated~     osteogenic orthodontics (PAOO). This study aimed to assess the effects of PAOO with BMP-2 on~     outcomes such as treatment period, bone density, healing and pain.~   "
12985|NCT03396887|"~     Alcohol dependence poses a major problem for Irish and UK society, placing a huge burden on~     the health system. It is difficult to treat and relapse is common. There is an urgent need to~     develop novel treatment methods. One growing area of intervention is the use of mobile phone~     technology to develop personalised, patient-centred treatments. These can be used in~     outpatient settings, allowing patients to manage their own illness and take control of their~     recovery. In this study the investigators will investigate how a smartphone application,~     UControlDrink, can help alcoholics stay abstinent from alcohol. The application consists of a~     number of features known to aid recovery such as supportive messages and online therapy.~   "
12986|NCT03396874|"~     This study evaluates the value of Gallium-68 labeled PSMA (68Ga-PSMA) for PET/CT imaging of~     prostate cancer recurrence. 68Ga-PSMA is a radioactive molecule, which binds to prostate~     cancer cells. Together with a PET/CT scanner, the distribution of 68Ga-PSMA can be determined~     in the body.~      To test this new drug, participants will receive an intravenous injection of Ga-68-PSMA and~     then have a PET/CT scan. The scan results will be made available to study participants and~     treating physicians.~   "
12987|NCT03396861|"~     This research study is being conducted to determine the safety and tolerability of~     subconjunctival injections of aflibercept in the treatment of pseudophakic cystoid macular~     edema that has not responded well to first-line standard of care treatment (eye drops).~      Pseudophakic cystoid macular edema (CME) is swelling of the retina that can occur weeks or~     years after cataract surgery and typically results in decreased vision. Subconjunctival~     injections are injections placed just beneath the clear membrane (conjunctiva) of the eye.~      A recent report of one patient who received two subconjunctival injections of a similar~     medication to the one being studied here indicated that subconjunctival injections of this~     class of medication may be an effective and less invasive alternative to intravitreal~     injections for pseudophakic CME. Because of the similarity of the drugs and the patient's~     treatment success, we would like to see if subconjunctival injection(s) of aflibercept will~     work in treating pseudophakic CME. If successful, the risk of an intraocular infection and~     glaucoma that comes with standard of care treatments might be greatly reduced.~   "
13335|NCT03392311|"~     The purpose of this study is to evaluate the efficacy and safety of Adipose derived~     Mesenchymal Stem Cells (AD-MSCs) plus Calpocitriol Ointment with moderate to severe~     psoriasis. Any adverse events related to AD-MSCs infusion will be monitored.The primary~     outcome is the reduction rate of PASI(Psoriasis Area and Severity Index) and treatment~     response will be computed from PASI before and after treatment.~   "
12988|NCT03396848|"~     In addressing the need for effective post treatment support for men (and their partners)~     following treatment for prostate cancer, the investigators will employ an innovative~     SHAReClinic (Sexual health and Rehabilitation eClinic Program) that emphasizes: 1) a~     bio-medical component (erectile rehabilitation), focused on the long term return of erectile~     functioning firm enough for penetration with or without erectile agents/devices; and 2) a~     psychological component (intimacy maintenance), involving the maintenance or restoration of~     couples' intimacy. Through comparison research, the eClinic will be analyzed and made~     comparable in quality to the programs offered currently at leading institutions in major~     metropolitan areas, thus providing personalized, comprehensive cancer care to all Canadians.~   "
12989|NCT03396822|"~     Multiple Sclerosis (MS) is an autoimmune disorder of the central nervous system. In MS,~     inflammation is known to attack areas of the brain, spinal cord, and optic nerves; resulting~     in disability. Current MRI technology provides an adequate view of the impact of MS on the~     white matter of the brain, which contains many of the connections between neurons.~     Quantification of lesions in the white matter due to MS are a standard part of clinical~     trials and clinical care in MS. However, it has long been known that MS not only can affect~     the white matter, but also the gray matter, which contains the majority of the nerve cells~     in the brain and can cause inflammation in the meninges (the protective tissue that surrounds~     the brain and spinal cord). Autopsy studies have shown that the inflammation seen in the~     meninges is driven by a B-cells, a subset of white blood cells and that meningeal~     inflammation may be responsible for damage to the gray matter of the brain.~      Ocrelizumab is a new treatment for multiple sclerosis. This medication works by targeting and~     destroying circulating B-cells. It is thought that this may reduce the level of meningeal~     inflammation in patients with multiple sclerosis. By reducing meningeal inflammation, this~     medication may result in less damage to the gray matter and subsequently less disability in~     MS patients.~      In this study, the investigators will evaluate the use of a method on 7 tesla (7T) MRI to~     identify inflammation in the meninges as a potential predictor of response to ocrelizumab~     treatment for multiple sclerosis. Further, the investigators will evaluate if this MRI~     technique can be used to monitor the long-term effect of the medication on meningeal~     inflammation and the development of damage to the gray matter of the brain.~   "
12990|NCT03396809|"~     Purpose: Intravitreal injection of medications has revolutionized the treatment microvascular~     diseases. These diseases often require regular, life-long injections. Ensuring patient~     comfort is important for compliance with long-term treatments. Patients receiving regular~     intravitreal injections often complain of progressive dry eye related discomfort. These~     symptoms are likely secondary to the use of povidone iodine as an antiseptic. Investigators~     hypothesize that punctal plugs could reverse the progressive ocular surface discomfort~     induced by povidone iodine during the post-procedural state.~   "
12991|NCT03396796|"~     This study aimed to evaluate whether vagus nerve-preserving laparoscopic splenectomy and~     azygoportal disconnection is effective and safe, and to determine whether a reduction in the~     incidence of postoperative complications of the digestive system improves postoperative~     quality of life compared with conventional laparoscopic splenectomy and azygoportal~     disconnection.~   "
12992|NCT03396783|"~     Many patients with polio sequelae have persistent and progressive worsening more than 15~     years after the initial damage, with loss of muscle strength, asthenia and musculoskeletal~     pain. In these patients, there is a denervation process associated with insufficient~     reinnervation. The frequency of this syndrome post-polio (SPP) is of the order of 20 to 60%~     according to the studies. In the literature, several studies have advanced the hypothesis of~     immune dysregulation to this late degradation, with greater expression of pro-inflammatory~     cytokines, and abnormal phenotypic expression of T cells in the bloodstream. In this context,~     the use of immunomodulatory immunoglobulin IV treatment was studied several times, with no~     significant result on pain, fatigue and muscle strength scores. In the absence of significant~     efficacy of immunoglobulin treatment, the objective of this study is therefore to define the~     immunological profile of patients with post-polio syndrome, compared with control subjects,~     in order to support the pathophysiology of this syndrome. to study the possible presence of~     an inflammatory syndrome associated with this syndrome. On the other hand, depending on the~     results found, referral to targeted therapies could be considered.~   "
12993|NCT03396770|"~     Acute kidney injury (AKI) is common after cardiac surgery. The diagnosis is based on the~     criteria defined by the Kidney Disease Improving Global Outcomes (KDIGO) classification:~     oliguria and elevation of serum creatinine. However, oliguria is not specific of AKI and~     elevation of serum creatinine is too late. Therefore, new methods have been developed to~     earlier assess the risk of AKI.~      Among those methods, it has been shown that the increase of urinary dosage, in the hours~     following the surgery, of two proteins (Tissue Inhibitor of Metallo-Protease 2 (TIMP2) and~     Insulin Growth Factor Binding Protein 7 (IGFBP7)) is associated with an increased risk of~     occurrence of AKI in patients hospitalized in intensive care unit. The Nephrocheck® test~     combines the urinary dosage of those two proteins TIMP2 and IGFBP7.~      Insofar as post-surgery low cardiac output is one curable cause of AKI, the early detection~     of early kidney risk allows corrective measures to stabilize hemodynamic state and thus to~     reduce the risk of AKI.~   "
12994|NCT03396757|"~     The timing of renal replacement therapy (RRT) in the context of severe acute kidney injury~     (AKI) is one the most debated issues in critical care medicine. The Artificial Kidney~     Initiation in Kidney Injury (AKIKI) was the first large prospective multicenter randomized~     trial published on this topic. This study (published in the New England Journal of Medicine,~     July 2017) showed no significant difference between an early and delayed RRT initiation~     strategy in term of mortality. Nearly 50% of patients escaped RRT in the delayed strategy and~     this strategy was associated with less catheter-related infections and faster renal function~     recovery. Two (serum urea concentration >40 mmol/l and oliguria/anuria for more than 72~     hours) of the 5 criteria which mandated RRT in the delayed strategy are still open to debate~     since they have never been shown to put patient at danger. To go further into our~     investigation of RRT criteria, the investigators designed a study that would compare the~     delayed strategy used in AKIKI that can now be considered as standard with another in~     which RRT is delayed for a longer period in the absence of a life-threatening complication~     (such as hyperkalemia or severe overload pulmonary edema).~   "
12995|NCT03396744|"~     Bipolar disorder (BD) is a severe brain disorder characterized by the recurrence of mood~     episodes. Depressive episodes in BD are frequently refractory and clinicians have few~     treatment options. Bright light therapy (BLT, also named phototherapy) is a promising~     emerging antidepressant strategy that is lacking evidence-based guidelines for its~     prescription in BD, including to avoid side effects such as manic switches. In this context,~     this study aimed to evaluate modalities of the BLT dosage (time of exposure) escalation~     depending on the tolerance (manic symptoms) in two groups exposed either during the morning~     or at mid-day.~   "
12996|NCT03396731|"~     Eight weeks, comprised of four weeks Run-in Phase of Standard Care (SC) treatment followed by~     four weeks of treatment allocated by randomisation (Treatment Phase).~      To compare two daily geko™ device treatment durations, six hours and 12 hours, in conjunction~     with SC, with each other and to SC alone, in patients with venous leg ulcers~   "
12997|NCT03396718|"~     In patients with squamous cell carcinoma of the oral cavity, the oropharynx and larynx with~     local advanced tumors (pathologic stage T3 = pT3) and or lymph node involvement (pN+)~     postoperative radio - or radiochemotherapy is the standard of care. Postoperative~     radiochemotherapy is indicated in patients with multiple lymph node metastasis, lymph node~     metastasis with extracapsular spread and / or residual tumor (R1-Status) after resection.~     Oropharyngeal cancer caused by HPV (human papillomavirus 16 or 18) is a distinct subgroup~     with a known sensitivity to radiotherapy (RTx) or radiochemotherapy (RCTx). Additionally a~     superior outcome after R(C)Tx over HPV negative patients was shown for patients treated with~     primary or adjuvant RCTx. To date it is unknown if the total dose of the radiotherapy can be~     safely reduced with the aim to decrease the therapy associated late effects.~      Patients with a HPV associated carcinoma that take part in the study will be treated with a~     reduced radiotherapy dose, chemotherapy will be prescribed based on clinical factors (number~     of affected lymph node, presence of extracapsular spread or residual tumor). Radiation dose~     will be reduced in two steps.~   "
12998|NCT03396705|"~     The liver is the only visceral organ with a tremendous capacity to regenerate. We don't yet~     understand how normal liver regeneration occurs (on a molecular level) or how to distinguish~     between normal and abnormal/neoplastic regeneration. This study will characterize the role~     of the different liver cell types in the regeneration process and will examine gene~     expression changes in the various liver cell types.~   "
12999|NCT03396692|"~     Rib fractures are frequent injuries found approximately in 10% severe trauma patient. Rib~     fractures were correlated in many studies with a higher morbidity and mortality. This~     impaired outcome is mainly due to pulmonary complications consequences including especially~     pulmonary contusions. Frequently, patients present difficulty deep breathing and coughing.~     These adverse effects can lead to the development of atelectasis, hypoxia, and respiratory~     failure with mechanic ventilation recourse. Effective pain management may prevent these~     complications and reduce the likelihood of developing chronic pain. A multi-modal analgesia~     regimen is widely employed combining regional and systemic analgesia. Epidural analgesia is~     considered by many authors to be the gold standard of pain relief although many side-effects~     are frequently describe including hypotension, urinary retention nausea and vomiting.~     Paravertebral nerve blockade is an adequate alternative that provide similar quality of~     analgesia with lower incidence of complication. However, the failure rate associates with PVB~     is about 13% and it may be associated with hypotension (4.6%), accidental vascular puncture~     (3.8%), accidental pleural puncture (1.1%) and rarely pneumothorax (0.5%). Recently, a~     description of the intercostal paraspinal nerve block. This technic was performed for~     patients undergoing thoracic surgery without complications.More recently, a description of a~     new approach to provide thoracic analgesia named the Posterior Paramedian subchoroidal (PoPS)~     block. The authors consider this technique provide an analgesia of the anterior and the~     posterior branch of adjacent thoracic nerves. The investigators propose to investigate the~     effect of Posterior exothoracic fascial block.~   "
13000|NCT03396679|"~     Comparison of the proportion of Psoriatic arthritis patients in ultrasound remission (i.e. no~     power Doppler synovitis, tenosynovitis, dactylitis, enthesitis, PD=0) depending on whether~     patient and physician's global assessment of disease activity are in agreement or in~     disagreement.~   "
13001|NCT03396666|"~     Published data indicate that rehabilitation in obese patients can result in a loss of body~     fat and weight that is correlated to improved physical and psychological condition and~     reduced morbidity and mortality.~      the Ivestigators hypothezise that the use of a mobile telerehabilitation solution will~     encourage the patient to adopt behavioral modifications allowing a reduction of fat mass~   "
13002|NCT03396653|"~     The primary aim of this study is to test the efficacy of patient-provided treatment for~     weight-loss maintenance.~   "
13003|NCT03396640|"~     In treatment of isolated medial unicondylar osteoarthritis of the knee (MU-OA), it is~     possible to choose between surgery with a unicondylar knee arthroplasty (UKA), or a total~     knee arthroplasty (TKA).~      Supporters of TKA suggest that this treatment gives a more predictable and better result,~     whereas supporters of UKA suggest that it is unnecessary to remove decent and functional~     cartilage in other compartments, and also that generally the UKA gives better results under~     certain circumstances. If the UKA is worn out or loosens, revision surgery will be relatively~     easy, whereas revision-surgery after a TKA can be much more problematic.~      Also, it is of great interest to measure the direct costs of these treatments. Both general~     hospital costs, but also costs in societal in terms of sick-days, pain-killer expenditure,~     and physiotherapy.~      The aim of this study is to compare the results, in terms of 1) patient-reported outcomes, 2)~     clinical results including prosthetic survival and 3) costs.~   "
13019|NCT03396432|"~     Complications related to infant (≤ 1 year) airway management are under-appreciated because of~     few rigorous and targeted studies. Investigators have recently shown that multiple tracheal~     intubation (TI) attempts are a key risk factor for intubation-related complications in small~     children. Tracheal Intubation using Video laryngoscopy (VL) has become popular in~     anesthesiology practice because of several advantages over conventional direct laryngoscopy~     (DL). Studies show that VL improves the view of the airway compared to DL, requires fewer~     intubation attempts, but may take more time to intubate the trachea. This study compares~     first attempt success of VL to DL in infants presenting for elective surgery.~   "
47384|NCT02946671|"~     To assess the safety of preoperative combination therapy with KW-0761 (anti-CCR4) and~     ONO-4538 (anti-PD-1).~      To assess the behavior of immune cells in peripheral blood and tumor.~   "
13004|NCT03396627|"~     Objectives: Upper eyelid retraction was believed to be maintained solely by voluntary~     contraction of the levator palpebrae superioris (LPS) and frontalis muscles, together with~     involuntary contraction of the sympathetically innervated Müller's muscle (MM). However,~     several studies have suggested that the LPS also undergoes involuntary contractions, and that~     a visual stimulus may not be the only trigger for frontalis muscle contractions. Recent~     studies hypothesized that the MM contains proprioceptive neuronal structures, which elicit~     involuntary LPS muscle contraction by the mesencephalic trigeminal nucleus via a continuous~     stretch reflex. We aim to identify proprioceptive structures in MM by means of histological~     examinations.~      Methodology: Prospective study. Collaboration of oculoplastics, ophthalmologists and a~     neuroanatomy specialist in Sheba Medical Center. 50 fresh MM specimens from patients~     undergoing Müllerectomies will undergo histologic examinations, including immunohistochemical~     staining and light and electron microscopy.~      Significance: Identification of proprioceptive structures in MM will be the first~     evidence-based proof of a proprioceptive mechanism in the eyelid. This might have a~     significant impact on future surgical management of eyelid procedures. Comprehensive~     understanding of the mechanisms underlying eyelid function is especially important in the~     management of children with ptosis who may have coexisting amblyopia.~   "
13005|NCT03396614|"~     Rationale: Radiation-induced cardiac and pulmonary toxicity after treatment for~     intra-thoracic tumors is a clinically relevant problem, which may jeopardize the benefit of~     (neo-adjuvant) (chemo) radiotherapy. Although cure rates are rising since the introduction of~     neo-adjuvant chemoradiation (neo-CRT) as current standard treatment for esophageal cancer~     (EC), recent studies showed that there is a substantial risk of non-cancer treatment-related~     death in these patients. Furthermore, this risk is underestimated as the cause of death of~     many patients remains unknown, since the distinction between tumor related and non-cancer~     related death can be difficult.~      Cardiac and pulmonary toxicity and its interaction as seen in pre-clinical studies might~     explain for these unknown deaths as suggested in several clinical studies. Clinical imaging~     studies performed shortly after treatment showed changes in different cardiac function~     parameters, all related to radiation dose parameters. Systematic imaging studies analysing~     subclinical toxicities at longer follow up have never been performed, most probably because~     of poor survival rates. However, identification of the magnitude of (subclinical)~     cardiopulmonary toxicity, by performing several cardiopulmonary function tests, is essential~     in this patient group as this toxicity is most likely the cause of the increased mortality~     after thoracic radiotherapy. For future perspectives, these results can be used to select the~     best diagnostic methods for a prospective cohort study to develop prediction tools for~     cardiopulmonary toxicity..~      Objective: The main objective of this study is to determine the most suitable diagnostic test~     to identify cardiopulmonary (dys)function in EC survivors treated with neo-CRT followed by~     surgical resection. Furthermore, we want to estimate the difference in cardiopulmonary~     (dys)function in EC survivors treated with neo-CRT followed by surgical resection compared to~     EC survivors who were treated with surgical resection alone.~      Study design: Cross-sectional pilot study~      Study population: 40 EC patients who were treated with curative intent by esophageal~     resection with or without neo-CRT~      Intervention (if applicable): Not applicable.~      Main study parameters/endpoints: As this is an exploratory pilot study to determine the most~     suitable diagnostic tests for future studies, there will be several endpoints related to~     (sub)clinical cardiopulmonary dysfunction.~      Signs of myocardial ischemia, systolic or diastolic dysfunction, rhythm and valve disorders,~     pericardial effusion and fibrosis, myocardial fibrosis, focal wall motion disorders and~     coronary calcifications will be analyzed. The cardiopulmonary (dys)function in EC survivors~     treated with neo-CRT followed by surgical resection will be compared to cardiopulmonary~     (dys)function in EC survivors treated with surgical resection alone.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: Several tests will be performed at one time point, 5-10 years after given~     treatment. If the findings of the test indicate cardiovascular complications, the patient~     will be referred to the cardiologist for further analysis and/or preventive measures. As one~     of the tests, cardiac MRI, including gadolinium (Dotarem 0.2 mmol/kg) enhancement will be~     performed. Potential side effects of gadolinium include brief headache, nausea (feeling sick)~     and dizziness for a brief time following the injection. Allergic reactions are rare.~     Furthermore, a cardiac CT scan will be performed with a total radiation exposure of 0.6 mSv~     (less than a third of the annual background radiation dose), the risks will be minimal.~   "
13006|NCT03396601|"~     NMDA antagonist drugs have increasingly been demonstrated to reduce symptoms of depression~     and suicidal ideation. NeuroRx has developed a sequential therapy consisting of IV NRX-100~     (ketamine HCL) for rapid stabilization of symptoms of depression and suicidal ideation~     followed by oral NRX-101 (fixed dose combination of D-cycloserine and lurasidone) for~     maintenance of stabilization from symptoms of depression and suicidal ideation. This study~     will test the hypothesis that that NRX-100 is superior to placebo in achieving rapid~     reduction in symptoms of depression and suicidal ideation in patients with Severe Bipolar~     Depression and Acute Suicidal Ideation or Behavior within 24 hours of administration.~   "
13007|NCT03396588|"~     The long term goals of our research are to establish the best pharmacological treatment for~     NAS and determine how pharmacologic treatment of NAS affects long-term developmental~     outcomes. The objective of this application is to evaluate the effectiveness of clonidine as~     a treatment for neonates with NAS, in a randomized clinical trial. Our central hypothesis is~     that clonidine will effectively treat drug withdrawal manifestations in neonates.~   "
13008|NCT03396575|"~     The standard of care for children with DIPG includes focal radiotherapy (RT) but outcomes~     have remained dismal despite this treatment. The addition of oral Temozolomide (TMZ)~     concurrently with RT followed by monthly TMZ was also found to be safe but ineffective.~     Recent studies in adults have shown that certain types of chemotherapy induce a profound but~     transient lymphopenia (low blood lymphocytes) and vaccinating and/or the adoptive transfer of~     tumor-specific lymphocytes into the cancer patient during this lymphopenic state leads to~     dramatic T cell expansion and potent immunologic and clinical responses. Therefore, patients~     in this study will either receive concurrent TMZ during RT and immunotherapy during and after~     maintenance cycles of dose-intensive TMZ (Group A) or focal radiotherapy alone and~     immunotherapy without maintenance DI TMZ (Group B). Immune responses during cycles of DC~     vaccination with or without DI TMZ will be evaluated in both treatment groups.~   "
13009|NCT03396562|"~     This study is designed to research the natural history of neurodevelopment, health and early~     hormonal function in infants with XXY/Klinefelter syndrome, XYY, XXX and other sex chromosome~     variations in an effort to identify early predictors of developmental and health outcomes.~     The Investigators will also evaluate different developmental screening tools in infants with~     sex chromosome variations so the investigators can develop recommendations for pediatrician~     caring for infants and young children with XXY/Klinefelter syndrome, XYY, XXX, and other sex~     chromosome variations.~   "
13010|NCT03396549|"~     The aim is to validate a new sham (control) method for use in transcranial direct current~     stimulation (tDCS) that is less discernible to participants from the real condition.~     Participants are often able to tell real from sham conditions. Correctly guessing real from~     sham undermines the integrity of evaluations of the value of tDCS as a treatment tool as~     responses may be in part or entirely the result of treatment expectation effects. The study~     will test a new sham method to reduce food craving and eating and test how much participants~     are able to discern it from the real or 'target' condition.~   "
13011|NCT03396536|"~     The objective of this study is to evaluate patient discomfort while performing oral hygiene~     (OH) around implants with and without keratinized mucosa (KM) and assess peri-implant soft~     tissue esthetic satisfaction and other clinical parameters at the 3- and 6-month follow-up~     visits. Group 1 will be implants with KM and Group 2 implants without KM. The hypotheses~     underlying this proposal are (1) that dental implants surrounded by KM will have better~     patient-reported outcomes regarding discomfort during brushing compared with those that lack~     KM; (2) that dental implants with KM will show more favorable clinical outcomes (plaque~     index, bleeding on probing, pocket depth and peri-implant recession) compared with those~     without KM and (3) that dental implants with KM will have higher patient peri-implant tissue~     esthetic satisfaction compared with those without KM.~   "
13012|NCT03396523|"~     The aim of the study is to investigate the effect of losartan (50mg, single dose) on the~     extinction of conditioned fear~   "
13013|NCT03396510|"~     This research study is evaluating a new way to deliver oncology care for patients with cancer~   "
13014|NCT03396497|"~     This is a Phase 1B study designed to assess the safety and tolerability of LYC-55716 given in~     combination with pembrolizumab to subjects with metastatic NSCLC, and to assess the~     combination for biologic and clinical activity in NSCLC.~   "
13015|NCT03396484|"~     A study is to see if methyldopa can change the immune system's attack on insulin producing~     cells in people at early stages of type 1 diabetes.~   "
13016|NCT03396471|"~     Single-arm phase 2 study to examine pembrolizumab and concurrent radiation to induce an~     abscopal effect in patients with previously treated carcinoma of unknown primary (CUP16-268)~   "
13017|NCT03396458|"~     This study will assess HBV (HBsAg, anti-HBc and anti-HBs) prevalence in the Turkish~     population living in Belgium. Additionally, the investigators will determine the risk factors~     for HBV infection and the uptake of screening, vaccination and antiviral treatment in this~     hard-to-reach Turkish population.~   "
13020|NCT03396419|"~     The purpose of the ImpACT-24col sub-study is to explore effect of SPG stimulation on the~     augmentation of collateral blood flow and to relate it to the subject's cerebral blood flow~     status, the extent of the collateral vessel potency prior to the stimulation and the relation~     of the vessel occlusion site to the vasodilatory effect by using digital subtraction~     angiography (DSA), the gold standard imaging technique to demonstrate collateral blood flow~     dynamics. The results of this study will further promote the knowledge towards optimization~     of SPG stimulation to treat acute ischemic stroke patients.~   "
13021|NCT03396406|"~     Forty patients with history of recurrent TN were recruited in Assiut University Hospitals,~     Pain Unit from 2012 to 2017. Before the study, all patients were given adequate and~     informative data about the nature of the study, interventional procedure and its possible~     complications, and a well-informed written consent was obtained from each patients.~   "
13022|NCT03396393|"~     The primary objective of the study is to assess the efficacy of DHA in patients with SLE.~   "
13023|NCT03396380|"~     The aim of this work is to evaluate the effect of vitamin D supplementation in overweight~     infertile women with PCOs undergoing induction of ovulation.~   "
13024|NCT03396367|"~     This research examines the efficacy of an individually-delivered intervention tailored for~     YMSM in relationships. The intervention - termed PARTNER - utilizes a brief (4 session)~     motivational interviewing format to target Pre-Exposure Prophylaxis (PrEP) uptake/adherence,~     HIV transmission risk behavior, and associated drug use.~   "
13025|NCT03396354|"~     Despite the theoretical superiority of robotic technology, surgical outcomes following~     robotic surgery have shown little benefit over conventional laparoscopic surgery. At present,~     studies have evaluated the value of robotic technology in clinical practice, including~     EndoWrist®, TilePro®, Firefly®, and Single-Site®, and have demonstrated the possibility of~     added clinical value, specifically in regards to decreased postoperative pancreatic fistula,~     usefulness as a multi-display education system, visualization of lymphatic channels, and~     implementation of reduced-port robotic gastrectomy. However, these technologies have only~     been applied independently and not in a well-organized manner.~      Maximizing radicality and safety while minimizing invasiveness are critical to bettering~     cancer surgery. We hypothesize that robot technology can affect these factors positively and~     that the use of appropriate parameters thereof could help shed more light on the benefits of~     a robotic system in gastric cancer surgery.~        1. Radicality: added benefit of Firefly® for lymph node visualization Number of retrieved~          lymph nodes can be considered a surrogate marker of long-term survival. In our proposed~          study, we will focus on the number of retrieved (lymph nodes as the primary outcome.~          Additionally, bleeding, which is known to be associated with poor overall survival, will~          be measured as a secondary outcome. Three-year recurrence free survival and 5-year~          overall survival will be followed up.~        2. Safety: benefit of Firefly® in differentiating lymph nodes from other organs and benefit~          of a magnified view and EndoWrist® Although robotic surgery reportedly shows less~          in-hospital and outpatient complication rates, a higher number of enrolled patients is~          needed to statistically validate these results. In the currently proposed study, these~          would be secondary outcomes. We have experienced the benefit of using fluorescence~          imaging to differentiate lymph node from biliary trees and pancreas parenchyma. As a~          reflection thereof, bleeding would be measured as parameter of unintended injury to a~          normal organ. To evaluate injury to pancreas parenchyma and postoperative pancreatic~          fistula, amylase/lipase levels in serum and drainage fluid will be measured.~        3. Invasiveness: value of Single-Site® Serum CRP (C reactive protein) levels (day 0, day 3,~          day 5, and 4 weeks after surgery) and pain scores (at 6 hr, 12 hr, 24 hr, 48 hr, and 72~          hr after surgery) will be measured to evaluate surgical trauma to the patients.~          Satisfaction on the wound will be evaluated using Korean version of the body image scale~          at one month after surgery.~   "
13026|NCT03396341|"~     The purpose of this study is to describe how women with BRCA1/2 mutations react to genetic~     risk modifier testing, and to examine how they make decisions about their healthcare.~   "
13027|NCT03396328|"~     Albuminuria is a known risk factor for cardiovascular disease (CVD), chronic kidney disease~     (CKD) progression, all cause mortality. Inhibition of the renin-angiotension-aldosterone~     system (RAAS) plays an important role in the reduction of albuminuria and preservation of~     renal function in patients with CKD and it is known that the daily intakes of sodium have a~     significant effect on the activity of RAAS. Dietary sodium restriction has been shown to~     enhances the blood pressure, albuminuria, and renal function preservation. Furthermore,~     recent study has shown that intensive low-salt dietary education reduces albuminuria in~     patients with CKD. The average sodium intake of Koreans is 4,791 mg/d, which is higher than~     other countries. It is difficult for medical staff in Korea to invest enough time in low salt~     diet.~      Recently, the development of health-related applications (apps) has been carried out~     worldwidely, and researches on lifestyle improvement using apps have been actively studied.~     However, there is no research yet on whether intensive education using an apps can affect~     lifestyle habits and thus changes in actual new features. Smartphone apps may provide an~     alternative to resource-intensive low salt diet-education. Therefore, this study aims to~     investigate the effect of intensive low salt diet training on the changes of albuminuria~     using application.~   "
13028|NCT03396315|"~     The primary goal of the study is to assess the extent to which bisphosphonate therapy will~     prevent decreases in bone mass that may occur after cessation of denosumab in premenopausal~     women with idiopathic osteoporosis (IOP) enrolled in AAAN0161 (FD05114) Denosumab for the~     prevention of post-teriparatide bone loss in premenopausal women with idiopathic~     osteoporosis.~      In addition, the investigator will observe participants for a second year off bisphosphonate~     therapy to assess duration of response.~      The hypothesis is that bisphosphonate therapy with alendronate or zoledronic acid, initiated~     after recovery of bone remodeling activity, will prevent significant bone loss after~     discontinuing denosumab.~   "
13029|NCT03396302|"~     This study aims to describe a totally self-applied online program to promote healthy~     lifestyles (nutritional education and exercise practice) for obese participants with~     hypertension. Participants will be recruited from users of a hypertension unit of a public~     hospital and will be randomized into two groups: experimental group and control group~     (treatment as usual). The experimental program (3 months) will be composed by 8 modules aimed~     for promoting healthy eating habits and increase physical activity. Assessment will include:~     body composition (BMI), blood pressure, glucose metabolism variables, and physical activity~     level (measured with accelerometers).~      Design: Randomized Controlled Trial.~   "
13068|NCT03395782|"~     Earlier studies has shown a correlation between older age and longer time for the rise in the~     end-tidal O2 concentration during pre-oxygenation. In this study the investigators aim to~     analyse this correlation more closely and investigate if the arterial partial pressure of~     oxygen (PaO2) as measured before the start of pre-oxygenation, with the patient breathing~     air, is a better predictor than age for estimating the time necessary for achieving the goal~     of pre-oxygenation.~   "
13351|NCT03392103|"~     The purpose of this study is to determine whether raltitrexed concurrent with IMRT is safe,~     tolerable and effective in the treatment for patients with local-advanced gastric cancer~     after D0/D1 radical resection.~   "
13030|NCT03396289|"~     Cerebral palsy (CP) is a permanent, non-progressive disorder in which the immature brain is~     affected by various causes in the prenatal, perinatal or postnatal period. Damage to the~     central nervous system in children with CP causes motor problems, balance and postural~     disorders. It is reported in the literature that the effects of balance and the effects of~     balance exercises in children with CP, similarly respiratory effects were also investigated.~     Balance and balance responses are especially important in children with ambulatory SP and~     balance problems are seen in most CP children. Insufficient control of respiratory muscles~     affects pulmonary ventilation negatively in children with CP. However, it seems that CP has~     limited articles in which respiratory muscle strength is investigated, and also limited~     studies involving inspiratory muscle training. Inspiratory muscle training is shown to~     improve pulmonary function and diaphragm (which is one of the core muscles) strength and have~     an effect on balance. Studies showed that respiratory muscle strength in children with CP is~     lower than in children with normal development. Nevertheless, there was no study showing the~     effects of respiratory muscle training on functional capacity and balance in children with~     CP. The aim of this study is to investigate the effects of balance training and inspiratory~     muscle training on functional capacity, balance, respiratory function and respiratory muscle~     strength in children with CP.~   "
13031|NCT03396276|"~     The purpose of this study is understand how many opioid emergencies are in Houston, to~     develop an opioid system of care in Houston, and to evaluate if patients who receive both~     medication assisted treatment (MAT) in the hospital and follow up by emergency medical~     services (EMS) post-discharge will enroll and retain in post hospital outpatient clinic~     recovery. This is a short-term pilot study to assess feasibility and provide initial~     quantification of prevalence.~   "
13032|NCT03396263|"~     The EatWellQ8 study aims to investigate the effectiveness of a mobile web application~     (e-Nutri), capable of delivering automated personalised nutrition advice, compared with~     face-to-face nutritional advice, in increasing diet quality.~      Dietary assessment is via the validated Food4Me FFQ (with an updated user interface that has~     been designed for better usability) and dietary feedback is derived according to adherence to~     an 11-item modified US Alternative Healthy Eating Index (m-AHEI).~   "
13033|NCT03396250|"~     To evaluate the relative bioavailability of Naproxen Sodium 220 mg and diphenhydramine~     hydrochloride (DPH HCL) 25 mg soft capsules (Test) versus Naproxen Sodium 220 mg and~     diphenhydramine hydrochloride 25 mg tablets (Reference) after a single oral administration~     under fasted condition in healthy adults subjects.~      To assess the safety and tolerability of the investigational products in terms of advent~     events (AEs) and clinical parameters.~   "
13034|NCT03396237|"~     Does vitamin D is more deficient in women with unexplained infertility than in fertile~     pregnant women or not?~   "
13035|NCT03396224|"~     The objective of this post-market clinical follow-up study is to confirm the safety and~     performance of the Avenir® Cemented Hip stem when used in primary total hip arthroplasty.~   "
13036|NCT03396211|"~     This is an open-labeled, single-center, Phase I study to evaluate the safety, tolerability,~     and efficacy of adding apatinib to ongoing nivolumab treatment in patients with unresectable~     or metastatic cancer. Approximately 9-18 subjects in Phase I dose escalation phase and up to~     12 additional subjects in Part II expansion phase. Total study duration will be approximately~     12 months: 6 months of recruitment plus 6 months of treatment.~   "
13037|NCT03396198|"~     The purpose of this study is to investigate the influence factors of gastrointestinal~     microbiome in infants.~   "
13038|NCT03396185|"~     The main purpose of this study is to evaluate the relapse free survival of patients who have~     EGFR-mutant stage IIIA-IIIB Non-small Cell Lung Cancer and receive Icotinib as consolidation~     therapy after synchronous or sequential chemoradiotherapy.~   "
13039|NCT03396172|"~     The main objective of the study is to assess the FreeDom innovative strategy (FreeO2 at~     Domicile) to reduce hospitalization duration in patients with COPD exacerbation. This~     strategy associates early hospital discharge, automated O2 flow weaning with FreeO2 system,~     telemedicine and tele-rehabilitation.~      The main hypothesis of this study is that the FreeDom strategy will reduce the number of~     hospitalization day by 50 percent at day 30.~   "
13040|NCT03396159|"~     our study aim to assess the validity of using mini fluid challenge to assess the volaemic~     status of patients after liver transplantation~   "
13041|NCT03396146|"~     The purpose of this study is to evaluate global endocrine function within type 1 and type 3c~     diabetic patients, helping pancreatic polypeptide measurement.~   "
13042|NCT03396133|"~     Participants in the Dyno arm were instructed to undertake once-day recording and transmission~     of a 30-second single-lead iECG trace to a secure server, plus additional submissions if~     symptomatic) over a 3-month period. Dyno traces were analyzed by an automated analysis~     software and cardiologists. Clinical review and appropriate care was arranged for those~     clinically significant arrhythmia. Patients in the RC group were followed up as normal~     methods including ECG, Holter.~   "
13043|NCT03396120|"~     Pulmonary hypertension (PH) is a common disorder among patients with interstitial lung~     disease (ILD). The symptoms are usually nonspecific and overlooked. Thus, a noninvasive~     screening modality is recommended for early detection of PH because of its potentially~     significant impact on treatment strategy and clinical outcomes.~      Objectives: To evaluate the usefulness of assessing forced vital capacity (FVC%), diffusion~     capacity of the lung for carbon monoxide (DLCO%), and FVC%/DLCO% ratio to predict pulmonary~     hypertension among patients with ILDs.~   "
13044|NCT03396107|"~     Caesarean section is a risk factor for the development of neonatal respiratory complications,~     mostly respiratory distress syndrome (RDS) and transient tachypnoea of the new-born, both in~     term and preterm infants.~   "
13087|NCT03395535|"~     This is a randomized study with two treatment arms: 'initial Selective Laser Trabeculoplasty~     (SLT) followed by conventional medical therapy as required' ('Laser-1st') and 'medical~     therapy without laser ('Medicine-1st'). It compares quality of life in the two arms at three~     years, while also examining the incremental cost and cost-effectiveness of Laser-1st versus~     Medicine-1st.~   "
13088|NCT03395522|"~     A total of up to 200 Symptomatic BPH subjects subjects will be enrolled into the study.~      Study duration will be 12 months post implantation with a follow-up visits at Year 2 and Year~     3.~   "
13045|NCT03396094|"~     Critically ill patients may need support for breathing by means of intubation, which is~     placement of a breathing tube into the windpipe. Rapid sequence intubation (RSI) is a method~     commonly used and is performed by administering medications to induce coma and muscle~     paralysis, followed by intubation to allow the ventilator to provide oxygen into the lungs.~     This procedure may be filled with potential complications.~      During RSI, the patient stops spontaneous breathing after medically induced muscle paralysis~     occurs. Adequate oxygenation before and during paralysis is crucial to increase the reserves~     and prolong the time that oxygen levels in the blood remain above 90%, called the safe apnoea~     period. If the oxygen reserves are insufficient, the blood oxygen level will drop and can~     lead to permanent brain damage or even death.~      This study aims to explore if delivering high-flow humidified oxygen at 60L/min via the~     nostrils would be superior to current methods of mask ventilation at 15L/min and nasal~     cannula at 15L/min, before and during paralysis respectively. If successful, this new method~     would allow for a longer safe apnoeic period and increase the chances for doctors to perform~     intubation successfully without the blood oxygen dropping below 90%.~   "
13046|NCT03396081|"~     Patients with heart failure (IC), after hospitalization, have a marked fragility: in France,~     in the first year, 29% die and 45% are readmitted to IC. Interventions improving the~     coordination of care providers at the time of discharge from hospitalization were tested;~     they showed a reduction in readmissions for IC (relative risk (RR) from 0.51 to 0.74) and~     all-cause mortality (RR 0.75 to 0.87). The Patient Return Program IC (PRADO IC), set up by~     the Health Insurance, offers assistance in the initiation of outpatient medical monitoring,~     and a nursing follow-up of 2 to 6 months depending on the patient's severity. The trial of~     PRADO began in the second half of 2013, and the first evaluation showed that the time to~     first treatment was significantly shorter, and that the readmissions rate and the 6-month~     death rate were unchanged.~      This study was of epidemiological type, comparative before-elsewhere. The difficulty of~     controlling for confounders in this type of study limits the scope of these conclusions. The~     efficacy hypothesis of PRADO IC is therefore always posed in the French context~   "
13047|NCT03396068|"~     NMDA antagonist drugs have increasingly been demonstrated to reduce symptoms of depression~     and suicidal ideation. NeuroRx has developed a sequential therapy consisting of IV NRX-100~     (ketamine HCL) for rapid stabilization of symptoms of depression and suicidal ideation~     followed by oral NRX-101 (fixed dose combination of D-cycloserine and lurasidone) for~     maintenance of stabilization from symptoms of depression and suicidal ideation. The SevereBD~     study will test two hypotheses: 1) that NRX-100 is superior to placebo in achieving rapid~     reduction in symptoms of depression and suicidal ideation in patients with Severe Bipolar~     Depression and Acute Suicidal Ideation or Behavior, and 2) That NRX-101 is superior to~     lurasidone alone in maintaining remission from symptoms of depression (primary endpoint) and~     suicidal ideation or behavior (declared secondary endpoint) over a six week period of~     twice-daily oral dosing.~   "
13048|NCT03396055|"~     Cervical radiculopathy and myelopathy are common degenerative disorders, which can create a~     large amount of social and medical burden. The aims of this study are(1) to investigate the~     functional outcomes progression before and after surgery, (2) to evaluate the biomechanical~     change and compensatory patterns of patients with or without decompression surgery, and (3)~     to design innovation intervention for the patients with cervical myelopathy and~     radiculopathy.~   "
13049|NCT03396042|"~     A prospective natural history study with systematic assessments and uniform follow-up to~     provide a high-quality dataset for assisting in the design of future clinical treatment~     trials involving patients with CEP290-related retinal degeneration caused by the common~     intron 26 mutation.~   "
13050|NCT03396029|"~     This randomized controlled trial aims to investigate the effect of an individually tailored~     lifestyle feedback letter and a leaflet on lifestyle in the context of sigmoidoscopy~     screening.~   "
13051|NCT03396016|"~     Factor V is a coagulation cofactor that is primarily produced by the liver. Previous data has~     suggested a correlation between factor V levels and graft dysfunction. The investigators~     hypothesize that Factor V may be a reliable biomarker for hepatic function after LT.~     Therefore, the aim of this study is to validate the use of Factor V as a predictor of graft~     dysfunction after LT. This is a single-center prospective validation study. Patients~     undergoing LT at the University Health Network will have plasmatic Factor V levels measured~     during postoperative week 1. Patients will be followed up to 12 months. The study outcomes~     will be early graft dysfunction, and graft and patient survival. Graft loss will be defined~     as need for retransplantation in the study period.~   "
13052|NCT03395990|"~     An observational study of the effect of femoral nerve block in addition to an adductor canal~     block for pain following total knee arthroplasty.~   "
13053|NCT03395977|"~     Cardiovascular disease is the leading cause of mortality worldwide. Endothelial dysfunction~     (ED) is the main mechanism which leads to atherosclerosis, where the balance between pro and~     antioxidant factors results in a decreased nitric oxide (NO) bioavailability. Xanthine~     OxidoReductase (XOR) is one of the main generators of reactive oxygen species (ROS). Uric~     acid (UA), a major antioxidant in human plasma and end product of purine metabolism, is~     associated with cardiovascular diseases since many years; however the precise mechanisms~     which relate UA to ED are still not well understood.~      The purpose of this study is to unravel the XOR and UA pathways involved in ED. Two groups of~     male participants (healthy and with metabolic syndrome) will be exposed to febuxostat (a~     strong and selective XOR inhibitor), or recombinant uricase (which oxidizes UA into~     allantoin) to vary UA levels and concomitantly control for confounding changes in XOR~     activity. Oxidative stress will be estimated by several markers. Endothelial function will be~     assessed by a laser Doppler imager in the presence of hyperthermia and endothelium~     stimulators. This study is specifically designed to untie the respective effects of UA and~     XOR pathways on oxidative stress and endothelial function in humans.~      The investigators will test the following hypothesis:~        1. An extremely low level of uric acid after uricase administration induces endothelial~          dysfunction and oxydative stress,~        2. A specific XO inhibitor limits unfavourable effects of the serum UA reduction elicited~          by uricase administration,~        3. Endothelial function and oxydative stress are further improved with febuxostat as~          compared to placebo,~        4. All these observations are more marked in metabolic syndrome subjects with an impaired~          endothelial function than in healthy subjects.~   "
13089|NCT03395509|"~     This is an intersectional and interdisciplinary screening program in Viborg Municipality,~     including 67 years old citizens. This observational study will estimate the~     cost-effectiveness of a combined screening program for the following conditions: Abdominal~     aortic aneurysm, peripheral arterial disease, carotid plaque, hypertension, arrhythmia, and~     type-2-diabetes. Furthermore, the incidence of the outlined conditions will be described and~     so will the result of the intervention initiated (secondary medical prophylaxis, smoking~     cessation, introduction to nutritionally deficient diet etc.)~   "
13054|NCT03395964|"~     It is well known that video-assisted thoracoscopic surgery(VATS) is preferred to open surgery~     for lung resection because of the use of smaller incisions and optimized postoperative~     recovery, including a shorter length of hospitalization. Studies have shown decreased~     operative and post-operative morbidity with decreased operative times. However, for small~     nodules (i.e. lesions <1 cm or those at a distance more than 1.5cm from the lung periphery),~     adequate identification of the target nodule has been be difficult by VATS, and a more~     significant resection or conversion to thoracotomy is occasionally needed to ensure complete~     resection.~      In order to improve nodule localization, a variety of preoperative localization methods such~     as CT-guide hook wire or methyl blue dye localization have been proposed and described to~     mark lung nodules for easier identification of small nodules and help guide resection during~     VATS. However, there are certain concerns. First, there are the difficult logistics in~     minimizing the time between the localization procedure and the subsequent surgery. Second,~     there is concern for patient safety, in particular pneumothorax, during transfer to and from~     the ward to the radiology department and in the frequent delays and waiting in reception~     areas prior to transfer to operating heaters. Finally, interdepartmental transfers and delays~     can also increase the risk of hook-wire dislodgement.~      Theoretically, the aforementioned disadvantage could be solved by performing the localization~     procedure and the lung surgery in the same hybrid operating room environment.~      In the current study, the investigators will perform intraoperative lung tumor localization~     in CGMH hybrid operation room (Room 51) equipped with the Siemens Artis Zeego system with~     DynaCT imaging capabilities. The system provides images equivalent to a 16-slice spiral CT~     scanner in a single 6-s sweep. Through a randomized study design, the advantages,~     disadvantages, and important considerations of this combined approach will be compared with~     traditional preoperative CT scan guided localization protocol.~   "
13055|NCT03395951|"~     Within clinical settings observation of hemodynamic changes (e.g. mean systemic filling~     pressure, cardiac output) in critically ill patients with a clinical indication for~     deresuscitation with intravenous diuretic therapy.~   "
13056|NCT03395938|"~     To determine amongst siblings of colorectal cancer patients:1. The knowledge, perception and~     barriers towards screening colonoscopy. 2. The current screening colonoscopy adoption rate.~     3. If patients would engage them through active engagement by healthcare providers in a bid~     to improve their receptiveness towards and partake in colorectal cancer screening. 4. The~     method(s) that Colorectal cancer patients adopt to communicate with them. 5. If tailored~     interventions addressing logistical, psychological and cost barriers could increase the~     adoption of screening colonoscopy.~   "
13057|NCT03395925|"~     Thyroid nodules are among the common alterations of the thyroid. Depending on the detection~     method the prevalence is between 20% and 50%, whereas the incidence increases with~     improvement of ultrasonic technology. The CelonPro Surge bipolar coagulation electrode~     operated with the compatible power control unit and compatible tube pump is indicated for~     ablation and coagulation of soft tissue, including thermal inactivation and/or volume~     reduction of locally defined tissue areas, such as tumors and metastases.~      The primary objective of the study is to assess the influence of radiofrequency ablation due~     to thyroid volume after 24 hours, 3 months, 6 months and 1 year.~   "
13058|NCT03395912|"~     Thus study evaluates the advantage of infiltration of the surgical wound by local anesthetics~     in cesarean section on post operative pain relief. In the study group before closing the~     skin, both sides of the incision (top and bottom) will be infiltrated by 30 ml of 0.25%~     BUPIVACAINE and ADRENALIN at 1: 200,000 concentration and then closing the skin. In the~     control group, the skin will be closed without infiltration. Our hypothesis is that~     subcutaneous infiltration of the surgical wound by BUPIVACAINE + ADRENALIN at the end of~     cesarean section will reduce the intensity of post operative pain.~   "
13059|NCT03395899|"~     International, open label, window of opportunity phase II trial that aims to evaluate the~     effects of immunotherapy based treatment combinations in women with untreated, histologically~     confirmed, operable, ER+, HER2-negative breast cancer.~   "
13060|NCT03395886|"~     The aim of this study is to compare the sedation effects between remifentanil and~     dexmedetomidine in post-cardiac surgical patients who developed noninvasive ventilation (NIV)~     intolerance.~   "
13061|NCT03395873|"~     The goal of this study is to test the safety of combination treatment with Avelumab and~     Decitabine in newly diagnosed AML patients who are unfit for intensive induction~     chemotherapy.~   "
13062|NCT03395860|"~     Low dose Rabbit Antithymocyte Globulin plus Low-dose post-transplantation cyclophosphamide as~     graft-versus-host disease prophylaxis in haploidentical hematopoietic stem cell~     transplantation for patients with hematologic malignancies~   "
13063|NCT03395847|"~     The goal of this clinical research study is to learn if pembrolizumab (when given either~     alone or in combination with ramucirumab) can help to control advanced gastroesophageal~     adenocarcinoma. The safety of these drugs will also be studied.~      This is an investigational study. Pembrolizumab is FDA approved and commercially available~     for the treatment of several types of cancer, but not gastroesophageal adenocarcinoma.~     Ramucirumab is FDA approved and commercially available for the treatment of gastroesophageal~     adenocarcinoma. It is investigational to use pembrolizumab alone or in combination with~     ramucirumab to treat gastroesophageal adenocarcinoma.~      The study doctor can explain how the study drugs are designed to work.~      Up to 30 participants will be enrolled in this study. All will take part at MD Anderson.~   "
13064|NCT03395834|"~     This study evaluates the change of tissue oxygenation during a vascular occlusion test using~     two NIRS ( O3TM and INVOS®). NIRS probe will be attached on volunteer's forearm during~     vascular occlusion test and tissue oxygenation change will be recorded~   "
13065|NCT03395821|"~     This study will verify if a comprehensive laparoscopic curriculum using virtual reality~     demonstrates skills transfer to the operating room, compared to the traditional teaching~     method.~   "
13066|NCT03395808|"~     The study evaluates the safety of IV tramadol managing post-operative pain following surgery.~   "
13067|NCT03395795|"~     The new NAVA® ventilatory mode with the SERVO-i ventilator (Maquet®) uses the electrical~     activity of the diaphragm (EADi) as a marker for triggering the respiratory cycle. The EADi~     is captured by the electrodes of a specific catheter (the Edi® catheter) placed in the~     esophagus as a regular gastric feeding tube, and relayed to the SERVO-i who displays it and~     delivers respiratory assistance according to measured Edi signal which allows synchronous~     assistance, proportional to the respiratory efforts of the patient.~      To date, no measure of the effectiveness of NAVA NAV has been performed in children with~     neuromuscular pathology whereas this technique could reduce the use of invasive ventilation,~     very iatrogenic in these fragile subjects.~   "
13352|NCT03392090|"~     This research study is evaluating the usefulness of a video and questionnaire to help cancer~     patients think about the goals of their care.~   "
47413|NCT02946294|"~     The purpose of this study is to compare the analgesic profile of modified pectoral nerves~     block and serratus plane block in patients undergoing mastectomy.~   "
13069|NCT03395769|"~     The purpose of the expanded access program is to allow physicians to provide treatment with~     investigational drug, AB-SA01, for patients with serious or immediately life-threatening~     Staphylococcus aureus infections, for which no alternative treatment(s) are currently~     available, and who meet the criteria for treatment under FDA's Expanded Access regulations~     and criteria set forth by AmpliPhi Biosciences Corporation.~      To be considered for expanded access, the request should be submitted to AmpliPhi by a~     qualified and licensed physician with expertise and facilities appropriate for the~     administration of the investigational medicine. Treating physicians should contact AmpliPhi~     by emailing expandedaccess@ampliphibio.com with Expanded Access Request in the subject~     line, and include in the email the treating physicians name,~     organization/hospital/institution, physical address, email address, telephone number, and a~     brief description of the indication/condition.~      Any approval of expanded access to investigational medicine must always comply with the~     applicable laws and regulations.~   "
13070|NCT03395756|"~     Background:~      The prevalence of repeat unprotected intercourse after EC use in the same cycle demonstrate~     the need for more self-bridging emergency contraceptive options. We propose the use of~     intramuscular Depot Medroxyprogesterone acetate (DMPA) as EC, which has been shown to inhibit~     follicular activity within 24 hours, and provide on-going contraception via suppression or~     disruption of ovulation.~      Objective:~      The objective of this study is to explore the potential of depot medroxyprogesterone acetate~     (DMPA) given as a 150-mg intramuscular injection for use as an emergency contraceptive.~      Study population:~      Healthy regularly menstruating women aged 18-39 years old will be invited to participate if~     they fulfill inclusion criteria. The participants will undergo a screening visit during the~     midluteal phase of their cycle, and will be enrolled if a serum progesterone level is~     >3ng/ml.~      Methodology:~      Participants will be assigned to one of three groups based on leading follicle size. Starting~     cycle Day 8, transvaginal ultrasounds will be performed to assess the size of the leading~     follicle. Once the follicle has reached the pre-assigned size, 150 mg IM DMPA will be~     administered. Blood will be collected for baseline hormonal assays. For 5 consecutive days,~     daily blood will be drawn for hormonal assays and daily transvaginal ultrasound will be~     performed to assess for signs of ovulation. The participant will then return for twice weekly~     progesterone levels for 2 weeks for study completion.~   "
13071|NCT03395743|"~     The purpose of the expanded access program is to allow physicians to provide treatment with~     investigational drug, AB-PA01, for patients with serious or immediately life-threatening~     Pseudomonas aeruginosa infections, for which no alternative treatment(s) are currently~     available, and who meet the criteria for treatment under FDA's Expanded Access regulations~     and criteria set forth by AmpliPhi Biosciences Corporation.~      To be considered for expanded access, the request should be submitted to AmpliPhi by a~     qualified and licensed physician with expertise and facilities appropriate for the~     administration of the investigational medicine. Treating physicians should contact AmpliPhi~     by emailing expandedaccess@ampliphibio.com with Expanded Access Request in the subject~     line, and include in the email the treating physicians name,~     organization/hospital/institution, physical address, email address, telephone number, and a~     brief description of the indication/condition.~      Any approval of expanded access to investigational medicine must always comply with the~     applicable laws and regulations.~   "
13072|NCT03395730|"~     The aim of this study is to compare the effectiveness of intraumbilical oxytocin and~     placental cord drainage in the management of third stage of labor.~      Does the use of intraumbilical vein oxytocin injection or the use of Placental cord drainage~     can cause a reduction of blood loss, Hb level drop, the length of the third stage of labor~     and the incidence of manual removal of the retained placenta during the third stage of labor~     in pregnant women after delivery of the infant?~   "
13073|NCT03395717|"~     Gait recovery is one of the main goals of post-stroke rehabilitation where robotic-assisted~     practice has shown positive outcomes. However, literature lacks of clinical studies on~     exoskeleton-supported gait rehabilitation. Recently, a wearable exoskeleton (Ekso™,~     EksoBionics, USA) has been commercialized for re-enabling patients to stand and walk,~     involving them directly in steps trigger through body weight balance. The main aim of this~     study is to assess the clinical and neuromuscular effects of exoskeleton-based gait~     rehabilitation in sub-acute and chronic stroke patients, compared to patients with similar~     characteristics who will conduct a traditional over-ground gait training.~      In this multicentric RCT, 162 stroke patients will be enrolled and randomly assigned to the~     Experimental Group (EG) or to the Control Group (CG). Patients will conduct at least 12~     one-hour-sessions (about 3 times/ week) of Ekso™ (EG) or traditional over-ground (CG) gait~     rehabilitation. Clinical evaluations (lower limb Modified Ashworth Scale- MAS; Motricity~     Index - MI; Trunk Control Test - TCT; Functional Ambulation Classification - FAC; 10-meter~     walking test - 10mwt; 6-minute walking test - 6mwt; Walking Handicap Scale - WHS; Time Up and~     Go - TUG) will be administered to patients at the beginning (T1) and at the end (T2) of the~     training period. The primary outcome is the distance performed during the 6mwt. A follow up~     study at 1 month (T3) and at 3 months (T4) after T2 will be conducted.~   "
13074|NCT03395704|"~     This study is a Phase 2 multicenter, randomized, placebo controlled, double-blind study. The~     primary objective of the study is to compare the effect of weekly dosing of LJPC-401~     (synthetic human hepcidin) versus placebo on transferrin saturation (TSAT) in an adult~     hereditary hemochromatosis patient population.~   "
13075|NCT03395691|"~     Ultrasound-guided axillary vein catheterization can be performed via the proximal or distal~     approach of the axillary vein. The aim of our study is to compare the first puncture success~     rates between the two approaches of ultrasound-guided axillary vein catheterization in~     cardiac surgical patients,as performed by junior intensivists with limited practice~     experience.~   "
13090|NCT03395496|"~     The aim of this study is to compare two pulpotomy medicaments in primary molars clinically.A~     total of 200 primary molars with deep caries were treated with two different pulpotomy~     medicaments (Mineral Trioxide Aggregate and BiodentineTM) in this study. The inclusion~     criteria for tooth selection were no clinical and radiographic evidence of pulp pathology.~     During 36 months of follow-up at 3-month intervals, clinical and radiographic success and~     failures were recorded.~   "
16371|NCT03352674|"~     This is an open-label randomised multicenter clinical study to compare immunogenicity of the~     drug products Insulin Glargine (Kalbe Farma) and Lantus (Sanofi -Aventis) in type 2 diabetes~     mellitus patients~   "
13076|NCT03395678|"~     Atrophic acne scars are a common and important sequelae of acne that affect up to 43-55% of~     patients with acne. Scarring impacts quality of life with reports of diminished self-esteem~     and frustration/sadness; additionally, some individuals report that their appearance even~     interferes with their professional lives. Though many treatments for acne scarring exist~     including ablative and nonablative lasers, subcision, and peels, none is without risk of~     adverse effects of pain, post-procedure redness or pigmentary changes. There have been no~     randomized studies directly comparing the effectiveness and safety profiles of microneedling~     (Dermapen) to 1,540nm nonablative fractional lasers (Palomar StarLux) in the treatment of~     atrophic acne scarring in skin of color. This clinical trial aims to determine which~     treatment modality -- microneedling or nonablative fractional laser -- is safer and more~     efficacious in the treatment of acne scarring in patients with skin of color.~   "
13077|NCT03395665|"~     The development and improvement in Preimplantation genetic diagnosis/screening (PGS) in~     association with the efficacy and security of vitrification and trophectoderm biopsy, more~     efficient stimulation schemes and laboratory improvements in culture and embryo selection~     have contributed to high success of the assisted reproductive technologies(ART). Transferring~     an euploid embryo avoids one of the main reasons of miscarriage and implantation failure (~     Rubio et al, 22016) and overcomes one of the most important confounding factors. Usually, the~     transfer of euploid embryos is performed under standard hormone replacement therapy (HRT) and~     are referred to as FET-PGS cycles( Frozen embryo transfer). The study of FET-PGS cycles with~     the transfer of a single euploid blastocyst is the best model for evaluation of the impact of~     the endometrial preparation . Among factors influencing FET outcomes, patient's age,~     endometrial preparation, endometrium thickness, endometrial pattern, number and quality of~     embryos transferred , difficulty at ET, recently P4 have received more attention .~      The importance of Progesterone (P4) in embryo implantation has been widely studied. P4 plays~     an important role in endometrial gland formation, embryonic implantation and pregnancy~     maintenance, both in natural and artificial cycles.~   "
13078|NCT03395652|"~     The aim of this study is to investigate the impact of maternal physical activity during~     pregnancy on pregnancy outcome. Primary, fetal growth during pregnancy abd birth weight will~     be examined.~   "
13079|NCT03395639|"~     A committee will judge the safety and effectiveness of edoxaban and the regular treatment~     (standard of care).~      All children in the study will receive free treatment. They will have a 2 in 3 chance to~     receive edoxaban, and a 1 in 3 chance to receive the standard of care for preventing blood~     clots.~      The study will find out if edoxaban is safer and more effective than the standard of care.~   "
13080|NCT03395626|"~     Probiotics, which are part of the human body, are microorganisms, which are known to have~     beneficial effects when consumed in a certain amount, and have the function of controlling~     intestinal flora and inhibiting inflammation. Recently, probiotics have received much~     attention in the treatment of hypersensitivity syndrome. The aim of this study was to~     investigate the effect of probiotic strains, ID-JPL934, in the diagnosis of irritable bowel~     syndrome.~      Overall satisfaction with improvement of bowel habits such as diarrhea and constipation as~     well as abdominal discomfort and abdominal discomfort in the group receiving ID-JPL934~     capsules (test food group or test group) and control group (control food group or control~     group) (0-10 point visual analogue scale) for each symptom before and after ingestion to~     evaluate the degree of improvement of the symptoms. The purpose of this study was to~     investigate the relationship between bacterial composition changes in the stool and the~     improvement of symptoms in the patients before and after ingestion.~   "
13081|NCT03395613|"~     Negative pressure wound therapy (NPWT) has been used in treating postoperative SSI with~     encouraging results and is now an accepted element in the arsenal of tools for treating these~     complications. The concept of applying NPWT to closed surgical wounds as a preventive measure~     is relatively new but draws on the inherent properties of the method which could~     theoretically lead to reduced seroma formation, wound dehiscence, increased capillary~     circulation and consequently better wound healing and fewer SSI.~      Given the incidence and the consequences of SSI in infrainguinal vascular procedures any~     appreciable decrease in the burden of these complications could have profound benefits for~     patients and healthcare facilities. As to date, there are no published data from randomized~     controlled trials investigating the effectiveness of this prophylactic measure.~      The aim of this study is to assess the effect of NPWT applied to closed surgical wounds~     directly after skin closure compared to standard sterile gauze dressing in reducing the~     incidence and severity of postoperative SSI in infrainguinal surgical wounds in patients~     undergoing elective, open vascular surgery.~   "
13082|NCT03395600|"~     This study investigated the effects of combination of different doses of epidural sufentanyl~     with different concentration bupivacaine and on the time to onset of epidural analgesia in~     women in early labour.~   "
13083|NCT03395587|"~     The primary objective of the study is to determine whether overall survival of newly~     diagnosed glioblastoma patients treated with lysate-loaded, mature dendritic cell vaccines as~     add-on to the standard of care consisting of resection, radiotherapy with concomitant~     temozolomide chemotherapy and subsequent adjuvant temozolomide chemotherapy is superior to~     the treatment with the standard of care alone.~   "
13084|NCT03395574|"~     in our study the investigators aim to assess the effect of terlipressin on cerebral~     oxygenation monitored by cerebral oxymetry and cerebral blood flow measured by transcranial~     doppler.~   "
13085|NCT03395561|"~     To study the effects of green coffee supplement on adropin, irisin, vaspine, systemic~     inflammation and oxidative stress in breast cancer survivors.50 breast cancer survivors who~     their treatment is over and referred to follow breast cancer clinic with will be randomly~     allocated to receive placebos or 2 capsules green coffe for 12 weeks; both groups will be~     advised to adherence the investigators' diet and exercise program too. At the first and the~     end of the intervention, adropin, irisin, vaspine, systemic inflammation and oxidative stress~     will be assessed and compared between groups.~   "
13086|NCT03395548|"~     In this study the investigators aim to investigate the changes of the intestinal microbiome~     in three different cohorts (IBD, IBS, healthy) after applying the uniform disruptive factor~     of osmotic diarrhea induced by macrogol. The investigators hypothesis is that ill people will~     show more severe changes of the microbiome than healthy people and that these changes persist~     longer.~   "
13091|NCT03395483|"~     An important goal of haemodynamic monitoring and resuscitation is early detection of~     insufficient tissue perfusion and oxygenation. The mesenteric haemodynamic response to~     circulatory shock is complex, and diagnosis of bowel ischaemia poses significant difficulty.~     Assuming blood flow is diverted from the peripheral tissue and the gastrointestinal tract to~     vital organs, during circulatory shock, an objective, simple and non-invasive method of~     detecting peripheral tissue perfusion impairment might detect this at an early stage.~      The peripheral perfusion index (PPI) reflects changes in peripheral perfusion and laser~     doppler flowmetry allows measurement of bowel tissue perfusion.~      The aim of this study is to explore the association between changes in peripheral and~     intestinal perfusion in patients undergoing elective colorectal surgery exposed to~     intraoperative haemodynamic challenges.~   "
13092|NCT03395470|"~     PXL770 is a direct activator of 5' adenosine monophosphate-activated protein kinase (AMPK)~     being developed by Poxel S.A. for the treatment of type 2 diabetes mellitus (T2DM). In Part A~     of this study, we'll test the safety, tolerability and pharmacokinetics (PK) of repeated~     doses. In Part B, we'll co-administer PXL770 and rosuvastatin (a HMG-CoA reductase inhibitor)~     to assess any drug-drug interaction.~   "
13093|NCT03395457|"~     The aim of this study is to determine if adding manual therapy to care as usual reduces the~     discomfort from chronic migraine compared to care as usual alone~   "
13094|NCT03395444|"~     This clinical study is designed to assesses the benefit of adding pulsed shortwave therapy to~     the postoperative pain and recovery protocol following total knee replacement. Pulsed~     shortwave therapy is a safe adjunct pain therapy for acute and chronic pain.~   "
13095|NCT03395431|"~     Dry eye disease (DED) is an umbrella term encompassing a range of diseases estimated to~     affect 14% of all adults aged 48 to 91. If left untreated, DED can lead to severe reduction~     in the quality of life of the sufferer. It can also cause loss of vision, pain in response to~     light, painful recurring stabbing sensations, and the feeling of grit in the affected eye(s).~     No curative agents for DED exist. Available conventional treatment options for DED such as~     artificial tears often only alleviate symptoms, have limited effectiveness, and in most cases~     patients may fail to respond; although the exact rate of treatment failure is unavailable in~     the published literature. Crudely, human tears with its vast constituents is essentially~     filtered blood and as such is an obvious source for a tear mimic containing the substances~     of tears. Blood, and several blood derived products, including autologous serum, have been~     studied as tear substitute candidates. This study proposes to test the use of finger prick~     autologous blood (FAB) technique in which whole blood is applied to the eye from a cleaned~     finger.~   "
13096|NCT03395418|"~     Asthma and COPD have a significant impact on public health, affecting about 8 million people~     in France and generating health care costs of 5.5 billion euros, almost 50% of which are~     dedicated to long-term treatments are essentially inhaled therapies.~      The good control of the disease depends on the patient's compliance, but also on the proper~     use of the devices used for the administration of inhaled drugs under penalty of the~     degradation of the control of the disease with major medical and medico-economic~     consequences.~      Thus, education of these patients in the use of devices must be an integral part of medical~     care. It comes up against the complexity of the therapeutic arsenal on the one hand and on~     the other hand with its time-consuming nature: this makes it incompatible with a realization~     in consultation.~      The ARGOS process is a telemonitoring project for the support of therapeutic education,~     consisting in setting up a concrete and real-time relay between prescribers and patients for~     the education of inhaled therapeutics.~      Its objective is to provide the answer to what is currently an unmet need in the management~     of asthma and COPD, with the prospect of a positive impact on the observance of these~     treatments and by consequently their clinical and economic efficiency.~   "
13097|NCT03395405|"~     This is a phase 2 multi-center, double-blind, placebo-controlled study of the efficacy and~     safety of nitazoxanide for the treatment of solid organ and hematopoietic stem cell~     transplant recipients with symptomatic diarrhea due to Norovirus. The study duration is 60~     months and subject participation duration is 6 months.~      160 male or female Hematopoeitic Stem Cell or Solid Organ transplant recipients, equal to or~     greater than 12 years of age with diagnosis of Norovirus will be selected for this study.~     Primary objective is 1) to assess the clinical efficacy of nitazoxanide for the management of~     acute and chronic Norovirus in transplant recipients.~   "
13098|NCT03395392|"~     NMDA antagonist drugs have increasingly been demonstrated to reduce symptoms of depression~     and suicidal ideation. NeuroRx has developed NRX-101 (fixed dose combination of D-cycloserine~     and lurasidone) for oral use in the treatment of bipolar depression with suicidal ideation.~     This study will test the hypothesis that NRX-101 is superior to lurasidone alone (the~     standard of care) in maintaining remission from symptoms of depression (primary endpoint) and~     suicidal ideation or behavior (declared secondary endpoint) over a six week period of~     twice-daily oral dosing.~   "
13099|NCT03395379|"~     The investigators aimed to evaluate the feasibility and safety of using ambient air to~     protect against thermal injury during RadioFrequency Ablation (RFA) for Renal Cell Carcinoma~     (RCC) based on data from cases at their institute.~   "
13100|NCT03395366|"~     End stage renal disease (ESRD) affects approximately 700,000 Americans of which approximately~     400,000 are on life-saving hemodialysis therapy. Hemodialysis can take a physical and~     emotional toll on patients, and most patients on hemodialysis describe poor quality of life.~     Patients on hemodialysis have worse health related quality of life (HrQOL) than patients with~     any other chronic illness including cancer and congestive heart failure. This poor quality of~     life can affect how well these patients manage their own health or their self-care, and can~     ultimately lead to poor health outcomes. Despite this, there are no commonly used programs to~     improve quality of life or self-care for patients on hemodialysis. The investigators have~     developed a simple 3-step program to improve quality of life and self-care for patients on~     hemodialysis. The first step involves presenting quality of life scores to the dialysis~     health care team so that a program can be designed. The second step involves 8-12 education~     sessions combined with behavioral training designed to improve quality of life and self-care.~     The final step is monthly re-evaluation of progress. In this study, the investigators will~     test this 3-step program, compared to dialysis education alone, to see if it improves quality~     of life and self-care. By improving quality of life and self-care the investigators believe~     patient outcomes including hospitalizations will improve.~   "
13102|NCT03395340|"~     Background:~      About half the people who have a hematopoietic stem cell transplant using donor cells get~     cGVHD. This is chronic graft versus host disease. Immune cells from the donor may see the~     body tissues in the person as foreign and attack, causing damage. The skin is the most~     commonly affected organ. Most cGVHD therapies have serious side effects. The cream~     ruxolitinib inhibits proteins that may play a role in cGVHD.~      Objective:~      To test the safety and effectiveness of topical ruxolitinib 1.5 percent cream in people with~     cGVHD of the skin.~      Eligibility:~      People ages 12 and older with epidermal skin cGVHD~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Blood and urine tests~      Skin sample taken (biopsy) to confirm the diagnosis.~      At the baseline visit, participants will have:~      Skin disease measured with rulers, photographs, and tracing the outline of skin lesions~      To complete questionnaires about their symptoms~      Blood and urine tests~      Some participants will also have a skin biopsy, or total body photographs while they wear~     only underwear.~      Participants will get the ruxolitinib cream and a placebo cream to apply to 2 separate areas~     of disease. They will do this twice a day for 6 weeks, if they do not have serious side~     effects. Neither the study team nor the participant will know which area will get ruxolitinib~     cream and the placebo cream.~      Participants will write down:~      When they apply the creams~      Any side effects~      Any medications they take~      Most participants will have 4 visits during the 6 weeks they use the creams. Some will have 3~     visits and a phone call to see how they are doing. All participants will get a call 4-6 weeks~     after they stop. Visits include physical exams, blood tests, skin disease measurements,~     questionnaires, and photos.~   "
13103|NCT03395327|"~     The 2014-2019 cancer plan emphasizes the need to reduce the impact of cancer on personal~     life.~      The impact of cancer on sexuality is multifactorial: fatigue, anxiety, impaired body image,~     chemotherapy treatment.~      None of these studies specifically assessed the early impact on the quality of sexual life of~     patients.~      The purpose of this study is to describe to describe the early evolution of the quality of~     sexual life of patients receiving adjuvant hormone therapy for breast cancer.~   "
13104|NCT03395314|"~     The purpose of this study is to test the potential of the rapid-acting anti-depressant~     ketamine to decrease suicidality in Borderline Personality Disorder (BPD).~      The rate of completed suicide in BPD is similar to that of depression or schizophrenia. There~     is currently no specific medication treatment for BPD.~      Ketamine is an FDA-approved anesthetic agent that has been shown to rapidly decrease~     suicidality and improve mood in people with Major Depressive Disorder (MDD). Though symptoms~     overlap, effective treatments for MDD and BPD differ. This clinical trial tests if ketamine~     also decreases suicidality and improves mood in BPD.~      This trial will also measure several other outcomes after ketamine versus placebo in BPD:~     adverse events, BPD symptoms, pain, social cognition, and neuroplasticity.~   "
13105|NCT03395301|"~     this study is to investigate the success rate of proximal tubal occlusion with coil devices~     in women with hydrosalinx and to observe there pregnancy rate with IVF-ET.~   "
13106|NCT03395288|"~     This is a study designed to evaluate the efficacy of a nutraceutical as a non-antibiotic~     treatment to prevent recurrent urinary tract infections in women that have completed~     menopause and are on vaginal estrogen therapy. An additional group of women with recurrent~     urinary tract infections that have completed menopause but are not using vaginal estrogen~     therapy will be followed while taking the nutraceutical. The study length is ninety days from~     the date that the study participant will be instructed is day 1.~   "
13107|NCT03395275|"~     Following the retrospective study ont he effectiveness of the microdose method of IT morphine~     therapy, the investigators are interested in measuring the sensory changes at 4 time points~     during the microdose method. The microdose method involves weaning the patient off oral~     opioids and maintaining an opioid-free period prior to initiating a very low opioid dose in~     IT therapy. The microdose method is a standard of care. The study involves measuring sensory~     changes to hot, cold, and pressure. Data collection will be performed at regularly scheduled~     clinic visits, examining range of doses, pain scores,dose escalations, quantifiable~     psychosocial factors ( not captured in previous retrospective study), and changes in sensory~     thresholds.~   "
13108|NCT03395262|"~     The aim of this study is to examine a novel weight loss formula with and without common~     stimulants on anthropometry and indices of cardiovascular disease risk.~   "
13109|NCT03395249|"~     This is a double-blind, placebo-controlled, ascending dose, multi-cohort trial. The study~     will be conducted in 2 parts: a single ascending dose (SAD) part, followed by a multiple~     ascending dose (MAD) part. In SAD, all subjects will receive 1 dose of SPR994 (100, 300, 600~     or 900 mg) or placebo, except for subjects enrolled in food effect cohorts in which subjects~     will receive one dose following a 10 hour fast and a second dose in the fed state following a~     minimum 5 days washout period. There is a single, optional, open-label control cohort that~     may enroll, in which all 8 subjects will receive Orapenem® (tebipenem pivoxil fine granules).~     In MAD, subjects will receive multiple doses of SPR994 (300 or 600 mg) or placebo for 14~     consecutive days at either BID or TID dosing. In both parts, cohorts will be exposed to~     increasing doses of SPR994 with various extended release formulations.~   "
13110|NCT03395236|"~     The objective of this prospective, multi-center, single arm study is to obtain further data~     on the safety and performance of the StellarexTM 0.014 OTW Drug-coated Angioplasty Balloon~     in the treatment of lesions in below the knee popliteal (P3 segment) and infra-popliteal~     arteries according to the Instructions for Use in Rutherford-Becker Classification (RCC) 3, 4~     and 5 patient populations. This study will be conducted in Europe across up to 10 centers in~     up to 75 subjects. Office visits will occur at 30 days, 6, 12, and 24 months post-index~     procedure.~   "
13111|NCT03395223|"~     This is an open label, uncontrolled, Phase 4 study including 10 patients who present in~     hospital/urgent care setting with acquired methemoglobinemia. The population may include~     pediatric and adult patients (males and females of all ages are included).~      The study will run in both the EU and the US. The aim of the study is to confirm safety and~     efficacy of ProvayBlueTM for the treatment of acquired methemoglobinemia and has been~     requested by the US-FDA as a Post-Marketing requirements.~   "
13112|NCT03395210|"~     This is an adaptive, open-label, dose-finding study of PRN1008 in patients with ITP who are~     refractory or relapsed with no available and approved therapeutic options, with a platelet~     count <30,000/μL on two counts no sooner than 7 days apart in the 15 days before treatment~     begins.~   "
13113|NCT03395197|"~     This study compares rPFS in men with DDR deficiency(ies) mCRPC treated with talazoparib plus~     enzalutamide vs. enzalutamide after confirmation of the starting dose of talazoparib in~     combination with enzalutamide.~   "
13114|NCT03395184|"~     The objectives of this study are to evaluate the efficacy, safety, tolerability,~     pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg~     for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an~     induction period of 12 weeks, followed by an open label extension period at doses of 50 mg~     and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.~   "
13115|NCT03395171|"~     The main objective of this study is to find a correlation between vitamin D deficiency and~     stress fracture occurrences in athletes who participate in high-risk activities. These~     high-risk athletes undergo elevated bone turnover, which requires adequate levels of vitamin~     D in order to support bone health. It is hypothesized that providing supplemental treatment~     to athletes showing lower than normal serum vitamin D levels will decrease the occurrence of~     stress fractures. By recording the dates and specific occurrences of fractures, it may be~     possible to correlate injury rates with seasons, providing more supportive data to~     pre-existing literature.~      This area of research is lacking in the quantity of prospective studies. Previous studies~     primarily focus on adolescent, elder, or military recruit populations. While literature has~     shown that vitamin D plays an important role in bone health, there are no previous studies~     that directly examine vitamin D deficiency and supplemental treatment in conditioned~     collegiate athlete populations. This study will add to the existing knowledge and will~     provide a more specific analysis for athletes.~   "
13116|NCT03395158|"~     New trauma alert criteria has been introduced in Sweden, and our aim in this study is to~     evaluate the outcome of the old and new trauma alert criteria in a cohort of 1.300.000~     inhabitants at six hospitals regarding over- and undertriage and number of alerts initiated.~     The Swedish trauma registry is used to identify eligible patients.~   "
13117|NCT03395145|"~     Evaluation of Bone volume Changes after socket preservation using Geistlich Bio-Oss® Collagen~     and Geistlich Mucograft® Seal compared to natural healing after tooth extraction~   "
13118|NCT03395132|"~     The trial is designed to compare the efficacy and safety of Fucicort® Lipid cream with the~     combination treatment of Fucidin® cream followed by betamethasone (Lianbang Beisong®) cream,~     or Fucicort® Lipid cream vehicle, when applied twice daily for two weeks. The trial is~     designed to demonstrate that treatment with Fucicort® Lipid cream is not inferior to the~     combination treatment with the mono component drugs, Fucidin® cream followed by betamethasone~     (Lianbang Beisong®) cream and that treatment with Fucicort® Lipid cream is superior to the~     treatment with Fucicort® Lipid cream vehicle. This is a 3-arm, parallel group, active- and~     vehicle-controlled trial comparing the efficacy and safety after 14 days treatment of~     Fucicort® Lipid cream, to Fucidin® cream followed by betamethasone (Lianbang Beisong®) cream,~     or Fucicort® Lipid cream vehicle, in subjects with clinically infected AD/eczema.~   "
13119|NCT03395119|"~     Purpose: A growing body of epidemiological data suggests an increased risk of cardiovascular~     events associated with air pollution. One of the common air pollutants, ozone, has been shown~     to induce oxidative stress and inflammation in the cardiovascular and respiratory systems.~     This proposed study is to examine the efficacy of fish oil and olive oil in modulating~     cardiovascular and pulmonary functions after ozone exposure. The objective is to understand~     the mechanistic basis for the health effects of ozone relative to those air pollutants.~     Treatment groups will include forty healthy young adults who will be given dietary~     supplementation of fish oil or olive oil. A control group will consist of 20 healthy~     volunteers who will receive no supplements. After 4 weeks, subjects will be exposed to clean~     air for 2 hours on the first day, then ozone for 2 hours on the second day. Cardiac rhythm,~     pulmonary function, vascular responses, endothelial function, and markers of coagulation and~     airway inflammation pre- and post- ozone exposure will be measured. This study is designed to~     build on the previous nutritional supplement interventional studies (UNC IRB # 07-0190 and~     UNC IRB # 11-1807), in order to understand the mechanism of action of particulate pollutants~     in comparison to that of ozone, a known oxidant air contaminant.~      Participants: A total of sixty healthy 18-35 year-old male and female subjects will be~     involved in the study.~      Procedures (methods): Forty healthy young adults will receive dietary supplementation~     consisting of fish oil or olive oil for 4 weeks. The control group includes 20 healthy~     volunteers who will receive no supplements in the study. After 4 weeks of supplementation or~     control regiment, each subject will be exposed to clean air for 2 hours on the first day,~     then ozone for 2 hours on the second day.~   "
13120|NCT03395106|"~     Views on vaccines range from those who are strongly supportive to those who are stridently~     opposed and will not budge from identity-based core beliefs about vaccines. In between these~     poles are numerous others who can delay, be reluctant (but still accept), or refuse/accept~     some vaccines for their children but not others. It is for these vaccine-hesitant parents~     that constitute the 'middle ground' of this spectrum where the most immediate and productive~     gains can be made towards enhancing vaccination acceptance and improving uptake. However,~     navigating this noisy communications environment is difficult, given the array of confusing~     and conflicting information available from multiple and competing sources. To date, there is~     no consensus on how best to use communication to respond to vaccine hesitancy. Building on~     two Canada-wide surveys of parents, the goal of this research is to identify which~     communication strategies show the greatest impact in reducing parental vaccine hesitancy and~     improving vaccination intentions.~      The specific objectives are to:~        1. Develop and pre-test four variations of news media stories that vary by source (parent~          versus physician) and content (intuitive versus deliberative);~        2. Examine the impact of vaccine hesitant parents' exposure to vaccine communications that~          vary in source (parent versus physician) and content (intuitive versus deliberative) on~          primary (vaccine hesitant attitudes) and secondary (vaccine intentions) outcomes; and~        3. Explore which media story variation may be more effective in improving vaccination~          attitudes and intentions for different parental decision-making styles (deliberative~          versus intuitive).~   "
13121|NCT03395093|"~     Fentanyl is analgesia medication. There has not pain nerve in the lung. Flexible~     bronchoscopy(FB) is used in the respiratory medicine. So people will not feel pain in the~     process of FB. The purpose of the study is to know if Fentanyl is useful in the conscious~     sedation of FB.~   "
13122|NCT03395080|"~     A Phase 2 Study Evaluating the Efficacy and Safety of DKN-01 as a Monotherapy or in~     Combination with Paclitaxel in Patients With Relapsed/ Refractory Endometrioid Endometrial or~     Endometrioid Ovarian Cancer~   "
13390|NCT03391596|"~     This study will examine whether an Internet-based Acceptance and Commitment Therapy (ACT)~     intervention is effective, firstly, on reducing depressive symptoms, and, secondly, on~     improving well-being of elderly family caregivers. In our study, we will compare 1) the~     experimental Internet-based ACT group to 2) standardized institutional rehabilitation carried~     out in rehabilitation centers and to 3) support provided by voluntary family caregiver~     associations~   "
13123|NCT03395067|"~     The aim of the present study is to evaluate the impact of a multidisciplinary treatment of~     obesity prior to IVF on global reproductive outcomes and maternofetal metabolic and~     cardiovascular risk factors.~      This is a randomized controlled trial in obese infertile women before starting an IVF cycle.~     The intervention is based on a structured multidisciplinary program in support groups, which~     includes diet, physical activity and psychological therapy. IVF will be started immediately~     after this therapy. Patients included in the control group will start an IVF cycle~     immediately after the randomization. The results of this study may allow the identification~     of patients who would benefit from obesity treatment, so as to establish appropriate~     preventive and therapeutic strategies and to reduce the maternal obesity impact in future~     generations.~   "
13124|NCT03395054|"~     This study aims to assess the effects of stabilization exercises on pulmonary functions and~     respiratory muscle strength. 42 participants with neck pain enrolled the study.~   "
13125|NCT03395041|"~     Recent studies have shown that the systemic inflammation caused by periodontal disease (PD)~     can determine important changes in the coronary arteries, favoring atherosclerosis~     progression and development of acute coronary syndromes (ACS). The aim of ATHERODENT study is~     to assess the interrelation between PD, inflammation and progression of coronary~     atherosclerosis in patients with ACS. Material and methods: This case-control observational~     study will enroll 100 patients (group 1 - ACS and associated PD, and group 2 -ACS and no PD),~     in whom the following data will be collected: (1) demographic and clinical data, (2)~     cardiovascular risk factors, (3) full characterization of PD markers, (4) systemic~     inflammatory biomarkers, (5) imaging biomarkers derived from transthoracic echocardiography,~     computed tomography, coronary angiography, optical coherence tomography and intravascular~     ultrasound, and (6) assessment of the presence of specific oral bacteria in samples of~     coronary plaques collected by coronary atherectomy, which will be performed during~     percutaneous revascularization interventions, when indicated in selected cases, in the~     atherectomy sub-study. The follow-up will be performed at 1, 3, 6, 12, 15, 18 and 24 months.~     The primary endpoint of the study will be represented by the rate of major adverse~     cardiovascular events (MACE rates) in PD vs non-PD patients and in correlation with: (1) the~     level of systemic inflammation triggered by PD and/or by ACS at baseline; (2) the~     vulnerability degree of atheromatous plaques in the coronary tree (culprit and non-culprit~     lesions); and (3) the presence and burden of oral bacteria in atheromatous plaques. Secondary~     endpoints will be represented by: (1) the rate of progression of vulnerability degree of~     non-culprit coronary plaques; (2) the rate of progression of atheromatous burden and calcium~     scoring of the coronary tree; and (3) the rate of occurrence of left ventricular remodeling~     and postinfarction heart failure.~   "
13126|NCT03395028|"~     The Investigators propose to test the hypothesis that GCSF therapy enhances the clinical~     outcome of Kasai operated Biliary Atresia (BA) patients. In this study, Investigators will~     conduct a dose determination for GCSF use in post Kasai subjects to support a future phase 2~     efficacy study. The first 3 post Kasai BA subjects with liver biopsy-confirmed BA will be~     given 5 ug/kg/d of GCSF in 3 daily subcutaneous doses starting on post Kasai day 3. A second~     group of 3 subjects will be assigned to the 10 ug/Kg/d dose after the 5ug/kg/d dose has been~     proven to be safe. The levels of circulating hematopoietic stem cells and a 1-month safety~     profile will be analyzed.~   "
13127|NCT03395015|"~     The aim of the study is to analyze the esthetic outcome of the first surgical repair of cleft~     lip and palate (CLP) patients.~      The aim of the study is to identify differences in the aesthetic evaluation of full-face and~     nasolabial region 3-D images of CLP patients following primary lip repair by laypeople.~   "
13128|NCT03395002|"~     The overall objective is to asses the bronchodilator effect of~     Tiotropium/Salmeterol/Fluticasone combination delivered via Discair® twice daily as compared~     with original products Seretide Diskus 500 mcg Inhalation Powder twice daily and Spiriva 18~     mcg Inhalation Powder once daily free combination treatment in patients with stable moderate~     to severe COPD.~      Spirometric measurements will be performed totally at 15 different time points at~     pretreatment and post-treatment (pre-dose, 15. min, 30. min, 1. hr, 2. hr, 4.hr, 8.hr and~     12.hr) during the first treatment day and at 16 different time points (15. min, 30. min, 1.~     hr, 2. hr, 4.hr, 6 hr, 8.hr and 12.hr) during the second treatment day.~   "
13129|NCT03394989|"~     The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test~     product to the reference product in adult patients with asthma.~   "
13130|NCT03394976|"~     A prototype rapid diagnostic test (RDT) to simultaneously screen for gambiense human African~     trypanosomiasis (HAT) and diagnose P. falciparum malaria (the HAT/malaria combo) has~     recently been developed. The performance of this prototype has been evaluated in a~     retrospective study that showed that its diagnostic performance for HAT and malaria was~     equivalent to the performance of the SD BIOLINE HAT 2.0 and the SD BIOLINE Malaria Ag P.f~     tests, respectively.~      The purpose of this study is to prospectively evaluate the performance of the test in~     settings where P. falciparum malaria is endemic, and which are either endemic or non-endemic~     for HAT. This will enable the assessment of the suitability of the HAT/malaria combo RDT as a~     diagnostic test for malaria, and a screening test for HAT in pre-elimination and~     post-elimination contexts, respectively.~   "
13131|NCT03394963|"~     Among several factors contributing to the occurrence of undernutrition, micronutrient~     deficiencies, overnutrition, and chronic disease, unhealthy diet is one of the most important~     factors that need to be addressed to tackle the burden in low- and middle-income countries.~     To maintain healthy eating in a population, it is crucial to develop and implement~     country-specific food-based dietary guidelines as well as monitor the adherence of the~     population with the guidelines. The aim of this study is to generate evidence that will help~     the development and validation of food-based dietary guidelines and a healthy eating index~     for Ethiopia. The method to develop Ethiopian food-based dietary guidelines is adapted from~     the 2015 Dutch food-based dietary guidelines and the Dutch healthy diet index development and~     validation process, and the 1998 FAO/WHO preparation and use of food-based dietary~     guidelines. A multidisciplinary technical working will be established to develop FBDGs. The~     working group will identify key messages for the guidelines that can address priority~     diet-related public health problems in Ethiopia based on the evidence that will be generated~     by the PhD student from Wageningen University and Research. The evidence generation will~     begin by identifying top ten diet-related diseases that lead to high morbidity and mortality~     in 2016. The nutrition situation (nutritional status, dietary pattern, and nutrient gaps)~     analysis will be conducted to define the objectives of FBDGs. A systematic review will be~     conducted by formulating research questions to address the objectives of the FBDGs. The FBDGs~     will be translated for a specific population subgroup using linear mathematical programming~     and validated for cultural appropriateness, acceptability, consumer understanding and~     practicality of the messages. Focus group discussions and key informant interviews will be~     conducted to validate the FBDGs. The most recent Ethiopian national food consumption survey~     data collected in 2011 will be used to develop a healthy eating index (HEI). The selection of~     a healthy eating component of HEI will be done based on the FBDGs. Validation of a healthy~     eating index will be conducted by comparing the HEI score based on 24-hour recall with the~     HEI score based on food frequency questionnaire for population characteristics and~     association with micronutrient intake with or without adjusting for energy and anthropometric~     measurement. Developing short food frequency questionnaire (FFQ) that can be scored with the~     index for dietary counseling and public health practice as well as dietary gap assessment for~     policy recommendation will be part of the study. Validation of FFQ will be conducted by~     collecting primary data among women of reproductive age in 500 households in rural and urban~     areas of Ethiopia. The data will be analyzed using the latest version of STATA, SPSS, and~     NVIVO software. Correlations and other appropriate advanced statistical technique will be~     applied as needed to answer the objectives of the study. Ethical approval will be received~     from the medical ethical committee of Wageningen University and Research and scientific and~     ethical review office of Ethiopian Public Health Institute. This Ph.D. research is supported~     by the Food Systems for Healthier Diets flagship of the CGIAR- Agriculture for Nutrition and~     Health Programme coordinated by International Food Policy Research Institute. Food and~     Agriculture Organization (FAO) and Ethiopian Public Health Institute are collaborators of~     this project to develop the FBDGs.~   "
13132|NCT03394950|"~     Acute ischemic stroke (AIS) is the most common type of stroke, which has high rate of~     morbidity, mortality and disability. A large number of studies have confirmed that the~     thrombolytic therapy can effectively open blood vessels and improve the functional prognosis~     of acute ischemic stroke. Therefore, all guidelines recommend giving thrombolysis treatment~     to acute ischemic stroke patients within 4.5 hours of onset. However, about 1/3 patients~     receiving thrombolysis will have good prognosis, while a large number of patients will still~     be disabled and even dead. How to improve the neurofunctional prognosis of thrombolytic~     patients has been a hot topic in the world.~      Butyl phthalide is type I chemical drugs. Some multicenter randomized, double-blind,~     placebo-controlled clinical trials have showed that acute ischemic stroke patients taking~     butyl phthalide has better lateral branch circulation and living ability score than patients~     taking placebo. Besides, butyl phthalide treatment is safe. The animal experiment indicated~     that buphthalein could significantly improve secondary side branch circulation, recover the~     microarterial diameter of the soft meninges in the ischemic region and increase the blood~     flow rate.~      Based on the discussion, we assume that: giving butyl phthalide to patients with acute~     ischemic stroke in advance, might promote and improve the formation of collateral circulation~     to freeze ischemia penumbra. Based on this hypothesis, we would like to explore the efficacy~     and safety of butyl phthalide combined with rtPA thrombolysis in the treatment of acute~     ischemic stroke.~   "
13885|NCT03385135|"~     This is a randomized trial assessing the impact of allopurinol on endothelial function in~     optimally treated diabetic patients with coronary artery disease. After initial screening,~     subjects were randomized to receive either optimal medical therapy (OMT) + allopurinol or OMT~     alone for 8 weeks. The dose of allopurinol was 300 mg for 4 weeks and 600 mg for 4 weeks with~     a 4-weekly check on hematology and biochemistry~   "
13133|NCT03394937|"~     The purpose of this study is to assess the safety and tolerability of cancer immunotherapy~     ECI-006 and to determine its ability to induce a measurable immune response against the tumor~     associated antigens.~      ECI-006 will be administered 5 times by injection in a lymph node in the groin or armpit.~      ECI-006 activates key immunologically active cells to direct the immune system against the~     cancer. Expected potential risks for ECI-006 are non-serious and related to the local~     administration of the product. Hence, the therapy suggested here has the promise to offer~     considerable benefit to patients without any major risk.~   "
13134|NCT03394924|"~     A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of~     EDP-305 in subjects with primary biliary cholangitis~   "
13135|NCT03394911|"~     Healthy adult human male facial skin surface lipid liquid pheromone given by mouth to opioid~     addicts cures them without any withdrawal symptoms whatsoever 250mg on chewing gum vehicle by~     mouth. Elevated mood eventually becomes accommodated after a few weeks. The pheromone~     contains volatile airborne sub-pheromones which cause aversive behavior (distrust,~     superstition, suspicion, arrogance, astonishment/stupidity, jealousy). Artificial jealousy~     can be avoided by patient isolation for 40 days until the pheromone taste wears off the~     saliva. The pheromone provided is odorless, colorless, and tasteless to the conscious brain.~   "
13136|NCT03394898|"~     The purpose of this study is to evaluate of body mass index and eating behaviour changes in~     female patients with fibromyalgia under medical treatment.~   "
13137|NCT03394885|"~     The main purpose of this study is to validate a safe dose of atezolizumab with dose-dense~     paclitaxel and carboplatin when utilized with neoadjuvant chemotherapy and interval~     cytoreductive surgery followed by maintenance atezolizumab in women with advanced ovarian~     cancer.~   "
13138|NCT03394872|"~     Patients with acute respiratory failure (ARF) who were receiving mechanical ventilator~     support, had significant pleural effusion (both transudates and exudates) and drainage plan~     were evaluated. Decision to drain, timing and duration of drainage were made by primary~     physician according to the intensive care unit (ICU) protocols.The estimated amount of~     effusion (mL) was calculated as the maximum pleura-lung distance (mm) x 20 and significant~     effusion is accepted as ≥ 800 mL according to thoracic ultrasonography (USG) performed by the~     intensivist. The amount of effusion drained, mechanical ventilator parameters, arterial blood~     gas results and hemodynamic data were recorded before, at the 1st hour and at the end of~     drainage up to 30 days after drainage.~   "
13139|NCT03394859|"~     The Electronic Medical Records and Genomics (eMERGE) Network is in its third phase and during~     this time is enrolling and sequencing 25,000 individuals on a custom sequencing panel of~     clinically relevant, actionable genes. The genetic results will be returned to participants~     and outcomes tracked through the electronic health records.~   "
13140|NCT03394846|"~     Movement integration programs that incorporate physical activity into academics are widely~     available for teachers to use, and have been shown to provide meaningful amounts of physical~     activity, improve on-task behavior, enhance cognitive function, and increase standardized~     test scores of children. However, teachers rarely use these programs. This project aims to~     use product testing and development methodologies to test current movement integration~     programs, identify critical attributes of those programs that hinder or enhance uptake by~     teachers, and develop a novel movement integration program based on those attributes.~   "
13141|NCT03394833|"~     The study aim is to investigate if preoperative volume bolus based on lean body weight could~     preserve mean arterial pressure during target controlled infusion of anaesthesia (TCI) or~     rapid sequence induction of anaesthesia (RSI) in non-cardiac, non-morbidly obese surgery.~   "
13142|NCT03394820|"~     The purpose of this study is to determine the optimal timing of IV dexamethasone for~     prolongation of ultrasound (US) guided supraclavicular brachial plexus block (SCB) in~     patients undergoing unilateral hand or forearm surgery at the Toronto Western Hospital.~     Investigators seek to answer which timing of IV dexamethasone will provide the maximum block~     prolongation. Investigators hypothesize that IV dexamethasone administered either before or~     after the block will further extend the duration of analgesia provided.~   "
13143|NCT03394807|"~     This study investigated the effectiveness of a surgeon administered, laparoscopic guided,~     regional anaesthesia technique.~   "
13144|NCT03394794|"~     This is a RCT aimed to assessing efficacy of kegel exercises,biofeedback, electrostimulation~     and transcutaneous neuromodulation on women with fecal incontinence, measuring its impact on~     anorectal physiology, cortical plasticity, clmical severity and the quality of life.~   "
13145|NCT03394781|"~     This is a research trial testing DUR-928 (an experimental medication). The purpose of the~     trial is to assess whether treatment with DUR-928 has any effect on the treatment of Primary~     Sclerosing Cholangitis (PSC). This trial will also assess safety (side effects).~   "
13146|NCT03394768|"~     Cardiac output (CO) monitoring is an important tool in critically ill patients with~     haemodynamic instability. Traditionally, this has been accomplished using the pulmonary~     artery catheter (PAC). However, its use has been associated with various complications such~     as pneumothorax, arrhythmia, infection, pulmonary valve injury and embolism. This has led to~     the development of various minimally invasive cardiac output monitoring devices such as the~     oesophageal Doppler, PiCCO®, NiCCO® and FloTrac®. These devices however have their inherent~     limitations and though minimally invasive, are still not without risks to the patient. More~     recently a completely non-invasive CO monitoring device, NICOM Cheetah® has been introduced.~     Its use is based on thoracic bioreactance and it involves placement of 4 electrodes on either~     side of the thorax and it analyses changes in the phase of electrical voltage signal to the~     current applied across the thorax. Initial validation studies on the NICOM Cheetah® device~     revealed promising results. This study intends to compare cardiac output monitoring~     capabilities of the NICOM Cheetah® device using the FloTrac® CO monitor as a reference.~   "
13147|NCT03394755|"~     This study evaluates in a dose-escalation manner, the safety, and preliminary impact on~     bleeding, and the preliminary effect on coagulation measures of increasing doses of~     allogeneic Thrombosomes in thrombocytopenic patients.~   "
13148|NCT03394742|"~     This study examines effectiveness of peer support of breast cancer patients. Half of the~     participants received peer support via telephone in addition to usual care and another half~     are give the usual care only.~   "
13149|NCT03394729|"~     The aim of the present study was to evaluate the effect of a xylitol containing propolis~     tablet on the salivary pH, total microorganisms count and soluble and insoluble extracellular~     polysaccharide concentration of the dental biofilm of adolescents in a randomized controlled~     clinical trial. In addition, evaluate the acceptability of the individuals regarding the~     characteristics of the tablets (appearance, taste, aroma and texture) through a~     questionnaire. To that end, healthy adolescents between 10 and 19 years old, without active~     carious lesions, who seek care at the Pediatric Dentistry Clinic of the Universidade Federal~     do Rio de Janeiro (UFRJ) will be randomly assigned to the two groups of the study: control~     group (propolis- consumers of tablets with propolis), respecting an interval of 30 days of~     rest between the consumption of the tablets. The study will be cross-checked and the~     principal investigator will be blind. The tablets will be given to the participants on an~     exact number of days of use and they will be instructed to consume two tablets per day for 7~     uninterrupted days. After 30 days of interval, they will consume the other type of tablet~     with the same recommendations of the first one. The total non-stimulated saliva collection~     will be performed at the beginning of the study (before the consumption of the tablets) and 7~     days after the intervention of each type of tablet, as well as the collection of the dental~     biofilm. Saliva and biofilm samples from all individuals will be identified and later~     analyzed in the laboratory, on the same day of collection, to measure the salivary pH, with~     the aid of a phmeter, and evaluation of the growth of total microorganisms (CFU / mg biofilm~     ), respectively. From the biofilm collected and stored in saline, concentrations of soluble~     and insoluble extracellular polysaccharides will also be measured by means of a~     spectrophotometer. Statistical tests will be used to compare the groups, with a significance~     level of 5%. As results, the propolis-containing tablet is expected to increase the salivary~     pH and decrease the number of total microorganisms in the dental biofilm.~   "
13150|NCT03394716|"~     This study aims to evaluate anatomical and functional changes during RT for patients~     receiving fractionated RT for brain tumors. Anatomical changes during RT will be registered~     and analyzed and if needed the radiotherapy plan will be modified for the individual patient.~     This means that the to be irradiated volume will be modified according to the shape changes~     of the tumor. The functional MRI sequences will be used to evaluate what parameters, and at~     which time point, are important for radiotherapy outcome.~   "
13151|NCT03394703|"~     Lung cancer is by far the leading cause of cancer death and has a lower relative survival~     rate than other types of cancer because most lung cancers are detected at an advanced stage~     when they are first diagnosed.~      Recently, a randomized control trial suggests that low-dose computed tomography (LDCT)~     enables an early stage detection and it has been increasingly accepted as an efficient~     screening method for high-risk individuals to reduce lung cancer mortality.~      In 2011, The National Lung Screening Trial (NLST) in the U.S. has produced results that~     screening high-risk smoking groups (who have at least 30 pack-year smoking history and~     currently smoke or have quit within the past 15 years) aged 55 to 74 years with LDCT reduced~     lung cancer mortality by 20%.~      Based on the evidence, Korean National Cancer Center has developed and published the~     guideline of lung cancer screening using LDCT for high-risk populations in 2015. The~     guideline recommends annual LDCT screening for high-risk smoking groups aged 55 to 74 years,~     with at least 30 pack-year smoking history and current smokers or past smokers who quit~     smoking within 15 years.~      The Korean Lung Cancer Screening project (K-LUCAS), a nationwide, multicenter, prospective~     study started to evaluate the effectiveness and feasibility of lung cancer screening with~     LDCT for considering implementation of a national lung cancer screening program in Korea.~   "
13152|NCT03394690|"~     To study the effects of green coffee supplement on leptin, adiponectin, ghrelin,~     anthropometric measurements, lipid profile in breast cancer survivors.50 breast cancer~     survivors who their treatment is over and referred to follow breast cancer clinic with will~     be randomly allocated to receive placebos or 2 capsules green coffe for 12 weeks; both groups~     will be advised to adherence the investigators' diet and exercise program too. At the first~     and the end of the intervention, leptin, adiponectin, ghrelin, anthropometric measurements,~     lipid profile will be assessed and compared between groups.~   "
13153|NCT03394677|"~     This is a multi-center, randomized, vehicle controlled, double-blind Phase 2 study in~     pediatric patients age 2-17 years old with mild to moderate atopic dermatitis.~   "
13154|NCT03394664|"~     This study will evaluate the effects of dietary carbohydrate and sugar consumption,~     independent of energy content, on body fatness and metabolism in a rigorous feeding study.~   "
13155|NCT03394651|"~     The present is a multicenter, observational study organized by the Prostatic Obstruction~     Investigation Team (POInT), with a main purpose of looking into the current status and~     symptom progression of male lower urinary tract symptoms patients in China.~   "
13156|NCT03394638|"~     Bariatric surgery is the only treatment with long standing effect of morbid obesity. The key~     elements to success are the patient-selection, an experienced bariatric team and a completed~     follow-up program. Follow-up programs can consist of, for example, providing social support~     in support groups, teaching psychological skills, such as coping with the body change or~     teaching self-regulation of body weight. Furthermore, follow-up is important for dietary and~     sports counselling. The experience of the team members and coaching skills are essential in~     indicating the suitable procedure if necessary and guide the patients through the process.~     Various studies showed a significant positive effect of a completed follow-up program after~     bariatric surgery on maintaining weight loss. There is a burden for this on site provided~     care as organizational and financial resources are not unlimited. Especially as the follow-up~     period is an obligatory 5 years or if possible life long. Even if this aftercare is provided,~     not all patients complete the complete program. Various reasons are possible for an~     increasing no-show-rate, the loss of enthusiasm for onsite visits could be one of them.~     Analogue to other chronic diseases, the addition of telehealth could be useful. Telehealth is~     the delivery of health-related services and information via telecommunications technologies.~     It encompasses preventative, promotive and curative aspects. Examples are exchanging health~     services or education via videoconference, transmission of medical data for disease~     management (remote monitoring) and advice on prevention of diseases and promotion of good~     health by patient monitoring and follow-up. The participation of eHealth has been~     investigated and considered useful in the treatment of obesity. In a systematic review~     self-measured blood pressure monitoring was associated with better control of hypertension at~     least in the first year. Its value in a bariatric tract has not been investigated. It can be~     hypothesized that self-control by eHealth could enhance clinical outcome as more weight loss~     and comorbidity reduction. Long-term realistic goals setting, consistent use of routines and~     self-monitoring has been proven effective for weight loss maintenance. Patients with higher~     self-control are more certain regarding their abilities, which cause higher commitment and~     adherence to the program. This eventually leads to more weight loss. For this purpose an~     online monitoring program was designed for our Obesity Centre (BePATIENT) to provide~     preoperative information as well as aids in the post-bariatric phase by self-control wireless~     devices for registration of biometric outcomes, teleconference opportunities and access to~     additional information. In a prospective trial the implementation in several degrees is~     evaluated.~   "
13157|NCT03394625|"~     Anterior maxilla (Esthetic zone) is very challenging area because of thin buccal plate of~     bone. After tooth extraction physiological process occur causing alteration of bone and soft~     tissue so, delayed placement of implant lead to loss of bone height and width. Immediate~     placement of implant is become essential to preserve the bone and soft tissue from loss.~      Socket shield technique is a recent technique which is by sectioning the root and extraction~     of palatal part and leaving buccal part of the root with its attachment of periodontal~     ligament and vascularization still intact then placing implant in palatal socket. This~     technique allow preservation of buccal plate of bone and soft tissue with minimum loss~     allowing better result in esthetic zone.~   "
13159|NCT03394599|"~     Motiview, an activity healthcare solution by Motitech, is finding solutions for elderly and~     people with dementia by reducing unnecessary emergency department visits, preventing~     falls/fall-injuries, improving management of complex health conditions, and improving brain~     health/cognitive fitness. Motiview is based on the premise that many of the challenges faced~     by this population may be caused by inactivity. The solution needs to effectively motivate~     them to be active year round. It also needs to accomplish this without increasing the~     resources within the health system. Motiview stimulates elderly people and people with~     dementia to increase their physical activity and cognitive training. By using videos,~     music/sound, the user can take a virtual bicycle trip through familiar surroundings and~     memories while facilitating activity participation and adherence in the older adult. Motiview~     is coupled to a mobile user-adapted cycle-trainer (TheraTrainer) that elicits physical~     activity as the individual pedals the trip. The unique part is adapting films and music~     according to the users' wishes and memories. By lessening the perceptions of difficulty,~     monotony, and discomforts associated with physical activity, participation and the experience~     of physical activity is enhanced. The research protocol of this project is designed to~     document the added value of Motiview for achieving physical activity participation. The~     hypothesis being that TheraTrainer bicycles will provide more activity when used with the~     video/audio overlay. Qualitative data will be gathered on the social aspects and reminiscence~     observed with the video/audit overlay from clients, care givers and staff.~      Information about Motiview can also be found on the website at https://www.motitech.no/en~   "
13160|NCT03394586|"~     TNF inhibitors have improved treatment options for patients with inflammatory bowel disease~     (IBD) and three TNF inhibitors, infliximab, adalimumab and golimumab are available for~     treatment of ulcerative colitis in Switzerland. However, these drugs have been tested under~     ideal conditions in randomized controlled trials. Real-world data are needed to complement~     this information. It is the aim of our study to test, whether patients with ulcerative~     colitis can be effectively treated with golimumab in a real world setting in Switzerland.~      The investigators will use data from the Swiss IBD cohort study (SIBDC) in Switzerland. They~     will identify all SIBDC patients with UC treated with Golimumab and perform a retrospective~     chart review. The investigators will acquire patient reported outcomes and objective measures~     for inflammation at baseline, at 6-10 weeks and at 6 and 12 months after golimumab treatment.~     Primary endpoint will be clinical response (i.e. meaningful improvement) at 6-10 weeks.~     Secondary endpoints will be clinical response at 6 and 12 months and clinical remission (i.e.~     free of symptoms of disease).~   "
13161|NCT03394573|"~     This study will evaluate the effectiveness of ranibizumab (Lucentis®) using two different~     treatment protocols in patients with vision loss from diabetic macular edema. While one group~     will be treated with an optical coherence tomography (OCT) guided 'treat and extend' regimen,~     the other group will be treated according to a visual acuity (VA) guided 'treat and extend'~     protocol. The patients will be randomized into two treatment arms using an automated~     randomization algorithm.~   "
13162|NCT03394560|"~     The aim of this study is to verify the efficacy of body weight-support treadmill training~     combined with high-frequency rTMS in improving the sensory-motor function of adult patients~     with chronic incomplete thoracolumbar spinal cord injury.~   "
13163|NCT03394547|"~     A single-centre, randomised controlled, double blind study comparing use of the Allay pulsed~     shortwave therapy treatment versus a placebo device or no treatment for management of primary~     dysmenorrhea.~   "
13164|NCT03394534|"~     The study aims to explore feasibility of implementing a tailored CGA to older adults with~     frailty and evaluate staff and patients perception of the intervention. In line with this,~     the objectives of the study are:~        1. To assess applicability of finding older adults with frailty using eFI and delivering~          subsequent CGA and care planning at patients' home~        2. To investigate staff and older adults' perception of CGA programme~        3. To assess the health care resource usage and cost of the CGA programme~        4. To measure key health related outcome domains including function, quality of life,~          loneliness, pain, falls and mobility.~   "
13165|NCT03394521|"~     The purpose of this study is to measure how many patients develop worsening glaucoma in the~     early years (2-4 years) of routine monitoring in hospital eye services. We will study a group~     of patients who were initially diagnosed as having glaucoma, or having high pressure in the~     eye (ocular hypertension) or having been diagnosed as a glaucoma suspect.~   "
13166|NCT03394508|"~     The study evaluates the safety and efficacy of intralymphatic allergen-specific immunotherapy~     given to adolescents and young adults who are allergic to grass or Birch pollen and have mild~     or moderate asthma. Patients will be treated with three intralymphatic injections; 1000 SQ-U~     x3 with 4-5 weeks interval, or placebo with 4-5 weeks interval. The patients receiving~     treatment will be given a fourth injection one year after the initial injections. The study~     is conducted in collaboration between Professor Lars Olof Cardell (ENT), prof Gunilla Hedlin~     (Pediatrics) and prof Marianne van Hage (Immunology).~   "
13167|NCT03394495|"~     This project aims to investigate the effects of an individualized exercise programme with and~     without BCE strategies for community-dwelling frail older people with general fatigue, so as~     to reduce their fatigue and improve their physical endurance, exercise self-efficacy, and~     habitual physical activity, while reducing their symptoms of frailty.~      Twelve district community health centres will be randomized to one of the three study groups:~     the combined (COMB) group, receiving the 16-week combined intervention consisting of~     individualized exercise training and Behavioural Change Enhancement programmes plus two~     booster sessions at 2 and 6 months after the programme; the exercise (EXER) group, receiving~     exercise training and health talks only; or the control group, receiving health talks only.~     Participants from each centre will be placed in their centre's corresponding group.~      It is hypothesized that the COMB group will achieve a significantly greater reduction in~     fatigue and a greater improvement in their physical endurance, exercise self-efficacy, and~     habitual physical activity, and a significantly greater reduction in their frailty symptoms,~     when compared with the EXER and control groups at 1 week and 6 and 12 months after completing~     the interventions.~   "
13168|NCT03394482|"~     The purpose of this study is to establish bioequivalence of Lu AF35700 between the clinical~     formulation and the commercial formulation for three tablet strengths; 5, 10 and 20 mg~   "
13172|NCT03394430|"~     Induction with high sevoﬂurane concentrations may trigger epileptiform~     electroencephalographic activity without motor or cardiovascular manifestations in healthy~     patients. No other symptoms were associated in this series, and only electroencephalographic~     monitoring allowed the diagnosis. Midazolam and dexmedetomidine are sedatives commonly used~     in children before surgery. Although the mechanisms are different, both have been reported in~     antiepileptic effects.~      This study was designed to compare the effects between intranasal midazolam or~     dexmedetomidine on epileptiform EEG during sevoflurane mask induction in children.~     Anaesthesia was induced with 8% sevoﬂurane. The patients were randomly assigned to Group A~     (n=15, preoperative intranasal normal saline), Group B (n=15, preoperative intranasal~     0.25mg/kg midazolam), and Group C (n=15, preoperative intranasal 1μg/kg dexmedetomidine). An~     electroencephalogram was recorded before and during induction up to 10 min after the start of~     induction.~   "
13173|NCT03394417|"~     Clinical significance and current evidence:~      Radiation dermatitis occurs commonly in patients receiving chemoradiation for nasopharyngeal~     cancer; 50 to 60% develop grade 2 or higher dermatitis. This can result in significant~     morbidity, reduced aesthetic appearance, decrease in quality of life and delays in treatment.~     Current literature does not conclusively support the use of one agent over another for~     prevention of radiation dermatitis. The choice of agents used in clinical practice is highly~     variable, with aqueous agents being one of the commonest.~      Specific Aims:~      The aim of this study is to evaluate if the investigational product (StrataXRT), a~     silicone-based gel, is superior to standard clinical practice in prevention of grade 2 or~     higher acute dermatitis in patients receiving chemoradiation for nasopharyngeal carcinoma.~      Trial Design:~      The study will be conducted using a prospective, double-blind randomized control trial in 2~     institutions. Each arm will receive standard radiation to a total dose of 70 Gray (Gy) with~     concurrent chemotherapy. The primary objective is to compare the prevention of dermatitis and~     the primary endpoint is reached when grade 2 or higher dermatitis according to the Common~     Terminology Criteria for Adverse Events (CTCAE) version 4.03 scale occurs. Secondary~     objectives will be evaluation of the time to onset of dermatitis, the time to complete~     recovery from dermatitis and the degree of pain. Assessment of the patient's skin will be~     done at baseline, weekly during treatment, 1 week post treatment and unless the skin has~     resolved to baseline then every week up until 6 weeks post-treatment, which will mark the end~     of follow-up. The safety end-point is reached when grade 4 dermatitis occurs.~      Hypothesis and statistics:~      The investigators aim to demonstrate a 30% reduction in the incidence of grade 2 or higher~     dermatitis with StrataXRT. Using a 2-sided test at significance level 0.05 to detect the~     difference with a power of 80%, the investigators envisage a recruitment of 100-150 patients~     in total. The study duration is estimated to be 2 years.~   "
13174|NCT03394404|"~     Atrial fibrillation (AF) is an irregular heart rhythm associated with significant morbidity~     and mortality. The pulmonary veins (the blood vessels carrying blood from the lungs into the~     left atrium) have been shown to send electrical signals into the heart that can cause and~     maintain AF. Pulmonary vein Isolation (PVI) is an established treatment where catheters are~     passed into the atria of the heart to deliver lines of scar to electrically isolate the~     pulmonary veins preventing them from transmitting these electrical signals into the left~     atrium.~      The ECG-I is a system which involves wearing a jacket with many ECG electrodes to record~     electrical activity from the surface of the body. A CT scan then shows where these electrodes~     are relative to the atria, and computer modelling is used to reconstruct the movements of~     electricity on the surface of the heart and therefore identifying where the drivers (tissue~     causing and maintaining AF) are located.~      Unfortunately, not all patients respond to PVI due to the drivers of AF being located in~     areas other than within the Pulmonary Veins. Identifying the drivers of AF is very difficult~     and the role they play has yet to be proved scientifically.~      The investigators intend to enroll 100 patients with persistent AF and perform atrial mapping~     using the ECG-I system. Solely pulmonary vein isolation will be performed. Patients will be~     followed up to see if the distribution of drivers as predicted by the ECG-I predicts~     outcomes. This may improve patient selection for this procedure.~   "
13175|NCT03394391|"~     The non-maintenance of ART adherence is a major barrier to the achievement of optimal~     treatment outcomes among adolescents living with HIV. ART adherence is a challenge among~     adolescents living with HIV because of lack of appropriate information, their unique~     emotional state and lifestyles but the most commonly quoted challenge to adherence is~     forgetting to take antiretroviral drugs. There is evidence to suggest that short message~     service (SMS) reminder- interventions may enhance drug compliance among adolescents living~     with other chronic diseases such as asthma and diabetes. Available literature underscores the~     need for randomized controlled trials (RCTs) of effective interventions to promote ART~     adherence among adolescents with HIV.~      The aim of this study is to evaluate the feasibility, acceptability, and efficacy of~     interactive and tailored SMS reminders on ART adherence among adolescents (15-19 years)~     living with HIV in Ogun State, Nigeria. The study hypothesizes that the use of personal~     mobile phones and SMS reminders for the improvement of ART adherence among adolescents living~     with HIV are feasible, acceptable, and effective.~      A single-blind, parallel-design (ratio 1:1), and multi-center RCT of 200 adolescent living~     with HIV who are non-adherent to medications will be conducted over a one-year period in~     Southwest Nigeria. All the participants will receive routine adherence counseling during~     clinic visits and one SMS reminder each for follow-up appointments 48 hours and 24 hours~     before the follow-up visit date. The intervention group will also receive daily ART adherence~     reminder SMS. Participants will be assessed at baseline and during follow-up visits at 4, 8,~     12, 16 and 20 weeks after the baseline. Baseline assessment of participants will include~     socio-demographic characteristics; HIV/AIDS risk behaviour assessment, Alcohol and Drug abuse~     assessment, Client Satisfaction Survey, ART adherence assessment, CD4count and viral load~     assessments. ART adherence and client satisfaction will be assessed at each follow-up visit~     while CD4count and viral load assessments will be done at 8 and 16 weeks.~      It is possible that tailored SMS reminders will mitigate the barrier of forgetfulness in~     ART-adherence and lead to improved drug compliance, viral suppression, and quality of life~     among adolescents living with HIV.~   "
13176|NCT03394378|"~     Obesity is a well-established risk factor for acute pancreatitis (AP). As for non-alcoholic~     fatty pancreas disease (NAFPD), it is evident that it is correlated with obesity. This is~     apparently the first study evaluating the association between NAFPD and severity of AP after~     taking into account several covariates.~   "
13177|NCT03394365|"~     This is a multicenter, open-label, single-arm phase 3 study to assess the efficacy and safety~     of tabelecleucel for the treatment of Epstein-Barr Virus-associated post-transplant~     lymphoproliferative disease (EBV+ PTLD) in the setting of solid organ transplant (SOT) after~     failure of rituximab or rituximab plus chemotherapy.~   "
13178|NCT03394352|"~     The purpose of the study is to demonstrate safety and feasibility of a decision support~     system aimed at improving activity-related insulin boluses in Type 1 Diabetes.~   "
13202|NCT03394040|"~     Background:~      Many people suffer from diarrhea every year. In the United States, it leads to about 130,000~     hospitalizations and 3,000 deaths a year. Researchers want to test a tool that may show them~     what germs cause diarrhea. It is a simple paper strip test and doesn t require electric~     power. This may make it easier for health care workers to more quickly fight diarrheal~     diseases.~      Objective:~      To test a tool that may detect what germs cause diarrhea.~      Eligibility:~      People already enrolled in an active NIH protocol who have diarrhea~      Design:~      Participants will have 1 or 2 studies. They will give information about their symptoms,~     current medicines, and basic personal data. They will give a stool sample.~      Part of each sample will be tested in a lab. The rest will be stored indefinitely. No~     personal data will be connected to the samples. The stored samples may be used in future~     research.~      Positive test results will be reported to a participant s primary doctor~   "
13179|NCT03394339|"~     Fruit and vegetables are a cornerstone of healthy dietary patterns and dietary guidelines~     worldwide. The supporting evidence, however, is largely derived from observational studies of~     protective associations with cardiovascular disease (CVD) in health-conscious populations or~     from randomized trials of the effect of specific fruit or vegetable derived nutrients on CVD~     risk factors. A growing body of literature has influenced a shift away from a focus on single~     nutrients to a focus on whole foods and dietary patterns. To what extent fruit and vegetables~     should contribute to dietary patterns for cardiovascular health and whether specific types of~     fruit or vegetables should be recommended is unclear. Although previous systematic reviews~     and meta-analyses have elucidated the association between the intake of total and some~     specific fruit and vegetables with cardiovascular outcomes, a comprehensive synthesis~     comparing the certainty of the evidence for the different types of fruit and vegetables in~     relation to a range of cardiovascular outcomes has yet to be completed. We propose to conduct~     a systematic review and meta-analysis of the available prospective cohort studies using the~     Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach to assess~     the association between different types of fruit and vegetables and different cardiovascular~     outcomes that include CVD, coronary heart disease [CHD], and stroke incidence and mortality.~   "
13180|NCT03394326|"~     This study investigates the effect of a low energy-density dietary prescription as compared~     to MyPlate recommendations in preschool children at risk for obesity.~   "
13181|NCT03394313|"~     Type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD) are closely related. T2DM~     risk equivalent for CVD and it remains the major cause of death in T2DM. Thus, patients with~     T2DM and CVD disease are at very high-risk of CVD-related mortality. Therefore, more~     aggressive metabolic and hemodynamic control is required in such patients to improve the~     prognosis. We recently initiated a cardio-metabolic clinical service at the Heart Hospital,~     where T2DM patients with existing CVD are simultaneously examined by Cardiologist and~     Diabetologist for optimal metabolic and hemodynamic control. We would like to start a~     clinical registry for all patients who attend this clinical service to collect import~     clinical data about this population. This registry will serve an important source for future~     clinical research in the field.~   "
13182|NCT03394300|"~     evaluation of the accuracy of iol power in high myopia using different biometry formula & iol~     master~   "
13183|NCT03394287|"~     This is a Phase II, Open-labeled,Two-arms Investigator-initiated Clinical Trial of SHR-1210~     (Anti-PD-1 Antibody) in Combination With Apatinib (VEGFR2 inhibitor) in Subjects with~     Advanced Triple Negative Breast Cancer.~      Subjects with Triple Negative Breast Cancer will be recruited. There are 2 cohorts in this~     study, the first cohort is SHR-1210 combination with apatinib daily dosing，the second cohort~     is SHR-1210 combination with apatinib intermittent dosing, each cohort will enrolle10-29~     subjects (Simons two stage design).~      This study aims to evaluate the efficacy and safety of SHR-1210 combination with apatinib in~     the treatment of advanced TNBC.~   "
13184|NCT03394274|"~     Investigators aimed to compare the restrictive and liberal blood transfusion methods applied~     in major surgical operations performed in Anesthesiology and Reanimation Clinic and~     investigate their effects on postoperative transfusion needs, morbidity and mortality.~   "
13185|NCT03394261|"~     The aims of the current study phase (R21) are: Aim 1. Develop a patient decision aid~     (PtDA-MAT) by incorporating best available scientific evidence on MAT as well as feedback~     from patients and clinical providers related to clinical priorities, perceived utility, and~     acceptability; Aim 2. Conduct pilot testing of the PtDA-MAT in an iterative process guided by~     an expert panel and involving key stakeholders (e.g., patients, physicians, policymakers) and~     field-testing.~   "
13186|NCT03394248|"~     The purpose of this study is to determine early detection of concussion for those at risk of~     developing symptoms and to be able to detect subconcussive cerebral impairment, and thus~     gaining a better understanding of the injury patterns for concussions in Men's and Women's~     Collegiate sports.~   "
13187|NCT03394235|"~     This study evaluates the optimizing parameters of long pulse Nd:YAG Laser for reducing the~     size of hair shaft diameter of the donor for hair transplantation. All participants will~     receive long-pulsed Nd-YAG laser treatments with three different parameters at the occipital~     area.~   "
13188|NCT03394222|"~     The purpose of this study is to conduct a randomized controlled trial to evaluate the effect~     of preoperative budesonide inhalation on arterial blood oxygenation and intrapulmonary shunt~     in patients received one-lung ventilation~   "
13189|NCT03394209|"~     Title: An adaptive study of the pharmacokinetics of favipiravir in patients with severe~     influenza Study Design: An open label, single group assignment, adaptive study to evaluate~     the pharmacokinetics of favipiravir in adult patients with severe influenza.~      In the first stage, participants will receive favipiravir 1600mg BID on day 1, followed by~     favipiravir 600mg BID for 9 days.~      If the proportion of patients with a minimum observed plasma trough concentration above the~     MEC (20μg/ml) at all measured time points after the second dose is less than 80% then a~     second patient cohort will be recruited and will receive favipiravir 1800mg BID on day 1,~     followed by favipiravir 800mg BID for 9 days.~      Intervention: The 1st stage: 1600mg BID on day 1, followed with 600mg BID for 9 days. Sample~     size: 15 The 2nd stage: 1800mg BID on day 1, followed with 800mg BID for 9 days. Sample size:~     15 Population: Males and females aged 18 years or older admitted to hospital with a positive~     PCR test for influenza and a PaO2/FiO2≤300mmHg or/and on mechanical ventilation for severe~     lung infection on admission.~      Sample size 15 or 30 severe influenza patients Research hypothesis The administration of oral~     favipiravir at either 1600mg/600mg BID or 1800/800mg BID will result in ≥ 80% patients~     achieving a minimum observed plasma trough concentration above the MEC (20μg/ml) at all~     measured time points after the second dose.~      Phase: Phase 2a, PK, safety and feasibility study. Description of Study Agent: Favipiravir~     (T-705) a viral RNA-dependent RNA polymerase inhibitor.~      Study Duration: 1 year Participant Duration: 38 days~   "
13190|NCT03394196|"~     Prospective, longitudinal, open label, HIV-2 viral load and antiretroviral resistance~     informed 2nd-line ARV implementation study.~   "
13243|NCT03393507|"~     The study is evaluated the effacy and safety of apatinib combined with chemotherapy in the~     advanced ovarian cancer~   "
13244|NCT03393494|"~     To compare the safety and efficacy of Perrigo's product to an FDA approved product for the~     treatment of Acne Vulgaris~   "
13191|NCT03394183|"~     Exercise is commonly recommended as a treatment for patients who present with peripheral~     artery disease (PAD). Although a great deal of research has supported the efficacy of~     exercise rehabilitation for PAD, it is infrequently implemented into clinical practices.To~     date, no comparison of cardiac rehabilitation efficacy and acute exercise responses has been~     made between patients with PAD and patients with coronary artery disease (CAD). Considering~     some of the parallels between the two conditions, as they are both atherosclerotic~     conditions, and the strong recommendations for exercise in both populations, it is worthwhile~     to compare the efficacy of cardiac rehabilitation responses. It is also unclear if the~     magnitude of response for PAD patients is dependent on biological sex and clinical~     presentation as this may influence the development of exercise prescriptions. This study will~     be a prospective two-arm cohort study with both groups (CAD and PAD) undergoing the same~     intervention (standard 6 month out-patient cardiac rehabilitation program offered at the~     Toronto Rehabilitation Institute Rumsey Centre). The primary variable of interest will be~     peak oxygen consumption (VO2peak) with a secondary variable of interest being functional~     capacity, as measured by the 6-minute walk test. Tertiary variables of interest will include~     walking impairment, as measured by the Walking Impairment Questionnaire, and quality of life,~     as measured by the Short Form-36 health survey (SF-36).The second objective of this study is~     to determine if the magnitude of responses to cardiac rehabilitation for patients with PAD~     are dependent on biological sex or type of PAD (asymptomatic, post-surgical intervention, or~     intermittent claudication).Exploratory objectives include comparing acute exercise responses~     (prescribed exercise training load, actual training load, exercising heart rate and rating of~     perceived exertion) between PAD and CAD patients.~   "
13192|NCT03394170|"~     The purpose of this study is to screen orthopedic surgery patients with and without a~     diagnosis of osteoarthritis for the presence of 11 pathogens associated with periodontal~     disease (PD) from a collection of oral rinse, synovial fluid and their synovium. The~     investigators hypothesize that there is a correlation between the presence of specific oral~     pathogens in saliva, synovial fluid and synovial tissue with clinical diagnosis of OA.~   "
13193|NCT03394157|"~     the investigator compare the efficacy of 3 types of metabolic surgery in the treatment of~     type 2 diabetes in obese patients , one of them is SASI bypass which is modification of~     Santoro's operation by performing a loop rather than Roux-en-Y bipartition reconstruction and~     the investigator are reporting the first comparative clinical trial as regard the clinical~     results of the outcomes of SASI bypass as a mode of functional restrictive and neuroendocrine~     modulation therapeutic option for obese type 2 diabetes .~   "
13194|NCT03394144|"~     This is a phase I, open-label study to assess the safety, tolerability, pharmacokinetics and~     preliminary anti-tumor activity of AZD9150 monotherapy and AZD9150 in combination with~     durvalumab in Japanese patients with advanced solid malignancies.~   "
13195|NCT03394131|"~     Carpal tunnel syndrome (CTS) is a common peripheral entrapment neuropathy in Rheumatoid~     arthritis patients proved by nerve conduction studies and ultrasound parameters, this study~     aims to evaluate the effect of hydro-dissection using 1% lidocain followed by low molecular~     weight Sodium hyaluronate versus 40 mg of triamcinolone acetonide, ultrasounic guided.~   "
13196|NCT03394118|"~     In this trial, anti-tumor efficacy of TAGRISSO in NSCLC patients in whom T790 mutations are~     detected by liquid biopsy.~   "
13197|NCT03394105|"~     In this trial, the effect of intrapleural docetaxel administration using medical~     pleuroscopywill be evaluated in Lung Cancer patient with malignant effusion.~   "
13198|NCT03394092|"~     The aim of this study is to investigate the changes in glycopeptides of serum immunoglobulin~     G in patients with acute myocardial infarction and the relationships between its change and~     prognosis.~   "
13199|NCT03394079|"~     This study is to establish the primary hypothesis that Optical coherence tomography-guided~     Percutaneous coronary intervention(OCT-guided PCi) is superior to Intravascular ultrasound~     guided Percutaneous coronary intervention(IVUS-guided PCI) regarding the target vessel~     failure at 1 year.~   "
13200|NCT03394066|"~     Background:~      Transcranial magnetic stimulation (TMS) is form of non-invasive brain stimulation. It is~     approved to treat depression. TMS may help decrease drug craving. It is important to~     understand how TMS affects the brain. Such a better understanding would help to design ways~     to treat drug addiction.~      Objectives:~      To learn how TMS affects the brain when it stimulates an area in the front of the brain.~     Also, to see how the stimulation affects the area stimulated and other connected areas.~      Eligibility:~      Healthy, right-handed adults ages 18 60 who are non-drug users.~      Design:~      Participants will be screened under protocol 06-DA-N415.~      Participants will have at least 3 visits. The first visit will last about 3 hours. All other~     visits will last up to 6 hours. Participants cannot use drugs or alcohol at least 24 hours~     before a visit. They cannot have more than half a cup of a caffeinated drink at least 12~     hours before a visit.~      Each visit will include a brief medical history update, urine test for drugs and pregnancy~     (if female), a breath test for alcohol and smoking, and questionnaires.~      Participants will have a TMS orientation visit. A wire coil will be placed on the head. An~     electrical current will pass through the coil to create a magnetic pulse that stimulates the~     brain.~      The other visits will include 2 sessions of TMS-MRI. Participants will lie on a table that~     slides into a cylinder. The TMS coil and the MRI coil will be placed over the head. Pictures~     will be taken of the brain with and without stimulation.~      Participants will complete a questionnaire about how they feel before and after each TMS~     session and in a follow-up call 2 3 weeks after their last session.~   "
13201|NCT03394053|"~     Background:~      Primary immunodeficiency disorders, or PIDs, are diseases that weaken the immune system. This~     makes it easier for a person to get sick. Some PIDs are mild and may not be diagnosed until~     later in life. Other kinds are severe and can be identified shortly after birth. Researchers~     want to learn more about PIDs by comparing data from relatives and healthy volunteers to~     people with a PID.~      Objective:~      To learn more about PIDs, including their genetic causes.~      Eligibility:~      People ages 0 75 with a PID or their healthy biological relatives the same ages~      Healthy volunteers ages 18 75~      Design:~      Participants will be screened with a medical history, physical exam, and HIV blood test. They~     may have a pregnancy test.~      Participants may repeat the screening tests.~      Blood taken at screening will be used for genetic tests and research tests. Participants will~     be told test results that affect their health. Some blood will be stored for future research.~      Adult participants with a PID may have a small piece of skin removed. The area will be~     numbed. A small tool will take a piece of skin about the size of a pencil eraser.~      Researchers may collect fluid or tissue samples from PID participants regular medical care.~     They will use them for research tests.~      Participants with a PID will have 3 follow-up visits over 10 years (for infants, 2 years).~     Visits will include a physical exam, medical history, and blood draw.~      Participants with a PID and their relatives will be called once a year for 10 years. They~     will talk about how they are feeling and if they have developed any new symptoms or~     illnesses.~   "
13203|NCT03394027|"~     Background:~      The new drug ONC201 have been shown to kill breast cancer and endometrial cancer cells in the~     laboratory. The exact mechanism of action is not completely clear yet, but the ONC201~     destroys the mitochondria inside the cells. Blocking mitochondrial activity may kill tumor~     cells, which would shrink tumors. Researchers want to see if ONC201 helps shrink tumors of~     certain breast or endometrial cancers and if that effect is maintained.~      Objective:~      To see if ONC201 shrinks tumors with a lasting effect.~      Eligibility:~      Adults ages 18 and older who have metastatic breast cancer (hormone-positive or~     triple-negative) or metastatic endometrial cancers.~      Design:~      Participants will be screened with:~      <TAB>Medical history~      <TAB>Physical exam~      <TAB>Heart, blood, and urine tests~      <TAB>CT and bone scans~      <TAB>Review of medical report and tumor sample~      Participants will have a tumor biopsy before starting treatment and after 5 weeks taking the~     study drug. A scan or ultrasound may be used to guide the biopsy. Patients will receive local~     anesthetic and a needle will remove a small piece of tumor.~      The study will be done in 28-day cycles. Every day 1 of each cycle participants will repeat~     most screening tests, will be seen by the physician and receive a supply of the study drug.~      Participants will take the study drug by mouth once every 7 days. They will keep a diary of~     when they take the drug and any side effects. During cycle 1, participants will get weekly~     calls to discuss their health and symptoms. Images will be repeated every 2 cycles to~     evaluate reponse to the treatment.~   "
13204|NCT03394014|"~     56 ASA physical status II and III patients, aged 45-75 year, undergoing elective below knee~     amputation were randomly assigned to receive either sciatic nerve block using a popliteal~     approach or a sub gluteal approach. Patients in both groups received same amount of LA and~     additional ultrasound guided femoral nerve block to ensure sensory block of the medial side~     of the leg. Success of the block was considered when the block is solid and doesn't require~     shifting to GA~   "
13205|NCT03394001|"~     The main goal of this study is to compare wound infiltration with ketorolac versus lidocaine~     for postoperative analgesia in total abdominal hystrectomy (TAH) operation.~   "
13206|NCT03393988|"~     This study,will evaluate the efficacy of ultrasound (US)-guided subcostal oblique TAP block~     together with IV infusion of Dexmedetomidine and fentanyl as a type of multimodal analgesic~     regimen in comparison with IV fentanyl based analgesia only in live liver donors.~   "
13207|NCT03393975|"~     To purpose of this study is to assess safety and efficacy of BAX 930 in the prevention and~     treatment of acute episodes of thrombotic thrombocytopenic purpura (TTP) in subjects with~     severe hereditary deficiency of ADAMTS13 (cTTP; defined as plasma ADAMTS13 <10%, as measured~     by the fluorescent resonance energy transfer-VWF73 [FRETS] assay)~   "
13208|NCT03393962|"~     This is a single-arm, open-label, phase I/II trial to evaluate the safety and efficacy of~     ovarian cancer-specific, engineered immune effectors (OC-EIEs) in women.~   "
13209|NCT03393949|"~     Lung cancer, of which incidence has been on the top of the list of male tumors, is a familiar~     carcinoma in respiratory system.Resection surgery has been the best approach for patients in~     early period. However, long duration and huge operative trauma lead to the decrease of~     immunological function of cancer patients, in addition, stress reaction in perioperative~     period, application of different anaesthetics during general anesthesia and postoperative~     pain can also affect the immunological function in varying degrees, increase the incidence of~     postoperative adversities.This study aims at discussing the effects on immunological~     function, cognitive function and postoperative adversities of elderly lung cancer patients~     after resection surgery caused by different doses of methylprednisolone in the single use.~   "
13210|NCT03393936|"~     This is a two arm, open-label, dose escalation and dose expansion clinical study to evaluate~     the safety and efficacy of infusion of autologous CCT301-38 or CCT 301-59 T cells in adult~     subjects with relapsed and refractory stage IV metastatic renal cell carcinoma.Subjects with~     ROR2 positive biopsy will receive CCT301-59. Subjects with AXL positive biopsy that are ROR2~     negative will receive CCT301-38.~   "
13211|NCT03393923|"~     Ostearthritis is a great source of pain. In symptomatic hip the pain can lead the major~     disability and poor quality of life. Understand the musculoskeletal factores can lead to a~     better clinical management. The muscle strenghening of posterolateral complexo of hip is a~     important consideration. General Objective: Perform a Kinetic analysis 2D using na anterior~     wedge. Specific objective: Analyze the influence of posterolateral hip complex. Controlled~     clinical trial, composed by 30 individuals with and without osteoarthritis of hip e will be~     used a tools; Analogic Visual Scale, manual dynamometry to analyze force and kinetic analyze~     of gait through of Myovídeo analysis software.~   "
13212|NCT03393910|"~     The purpose of this study is to investigate patients self-reported comfort levels during each~     section of the pelvic exam.~   "
13213|NCT03393897|"~     In a recent study (Vignon 2017), respiratory variations of the diameter of superior vena cava~     had a greater diagnostic accuracy than pulse pressure variations and inferior vena cava~     respiratory variations in 540 medical and surgical ICU patients. But this indicator has not~     been investigated yet in cardiac surgery. The investigator aim to study respiratory~     variations of superior vena cava for predicting fluid responsiveness after cardiac surgery.~      In post-operative cardiac surgery patients with hemodynamic failure, the investigator will~     measure respiratory vena caval variations with TEE (Trans oesophageal echocardiography).~     Then, the investigator will evaluate fluid responsiveness after a fluid challenge~     (Trendelenburg).~      A ROC curve will be constructed in order to assess the optimal sensitivity and specificity of~     this parameter.~   "
13214|NCT03393884|"~     This is a randomized, open label, multicenter trial to evaluate the safety, dosing, efficacy~     and biological activity of intraperitoneal GEN-1 plus NACT compared to NACT alone.~   "
13215|NCT03393871|"~     The background for performing the present study is to compare the mass calculations by CT~     scanning and by invasive absolute blood flow measurements and thereby corroborating both~     methods.~   "
13216|NCT03393858|"~     The purpose of this study is to investigate the clinical efficacy and toxicity of anti-PD-1~     monoclonal antibody plus autologous dendritic cells-cytokine induced killer cell (DC-CIK)~     immunotherapy combined with hyperthermia in advanced malignant mesothelioma~     patients.Furthermore,to characterize response to therapy,the investigators intent to explore~     the predictive biomarker for this regimen.~   "
13217|NCT03393845|"~     Pembrolizumab Plus Fulvestrant in Hormone Receptor Positive, HER-2 Negative~     Advanced/Metastatic Breast Cancer Patients~   "
13218|NCT03393832|"~     Gastroschisis is a rare abdominal wall defect. Though survival rate is high, there are~     significant complications related to feeding intolerance and infections. Recently, oral care~     with breast milk has been studied in extremely premature infants and has been shown to~     improve both feeding tolerance and protect against infection. Though only studied in~     premature infants, it is likely that other populations of patients can benefit form oral care~     as well. This study is a randomized controlled trial aimed to demonstrate the benefits of~     oral care with all breast milk (either mother's milk or pasteurized donor breast milk) in~     infants with gastroschisis. Additionally, the investigators will evaluate how oral care with~     all breast milk affects the intestinal bacterial environment and how oral care with all~     breast milk affects the secretion of certain proteins from the salivary gland.~      Primary hypothesis: The primary objective is to compare the magnitude of increase in~     intestinal microbiota alpha diversity over a four week period between the two study arms~     using a paired analysis.~      Secondary hypothesis:~        -  Oral care with breast milk will decrease the days to start enteral feeds after primary~          surgical closure inpatients with gastroschisis.~        -  Oral care with breast milk will decrease the days to reach full enteral feeds of 140~          cc/kg/day in patients with gastroschisis.~        -  Oral care with breast milk will decrease length of stay in patients with gastroschisis.~        -  Oral care with breast milk will increase secretion of certain proteins, such as vascular~          endothelial growth factor, from the salivary gland.~   "
13219|NCT03393819|"~     This study will assess the efficacy of two of the most commonly used surgical~     skin-preparation solutions: Chloraprep (chlorhexidine-alcohol) and Duraprep (iodine-alcohol)~     at eliminating bacteria from the hip site by evaluating the residual bacteria present~     following surgical skin-preparation.~   "
13220|NCT03393806|"~     This study is multicenter, double-blinded parallel group design, where participants with~     moderate to severe asthma with AFAD will be enrolled. Participants will receive three doses~     of 10 milligrams/kilogram (mg/kg) of GSK3772847 every 4 Weeks versus placebo along with~     standard of care. Participants will be randomized in 1:1 ratio to receive either 10 mg/kg~     GSK3772847 intravenously (IV) or matching placebo IV. Participants will receive study~     treatment on Week 0 (Day 1), Week 4 and Week 8. The total duration of the study will be 28~     Weeks and approximately 46 participants will be randomized.~   "
13221|NCT03393793|"~     Heart transplantation (HTx) is a procedure which is hindered by several complications. The~     HEARTS registry aims to allow the analysis of risk factors of all post-HTx complications. It~     consists in an exhaustive data collection at the moment of inclusion, i.e. HTx, knowing that~     patients underwent a full-fledged evaluation beforehand to evaluate their aptitude to being~     transplanted.~      Post-HTx complications include but is not limited to: all-cause mortality, AMR, ACR, CAV,~     AKI, sepsis, cancer, psychological disorders, metabolic disorders.~   "
13222|NCT03393780|"~     The purpose of this study is to monitor the use in routine clinical practice of REKOVELLE®.~     This study will collect information from patients who never underwent previous in vitro~     fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) treatments for up to three~     consecutive treatment cycles.~      The ovarian stimulation protocol with REKOVELLE®, a new recombinant human Follicle~     Stimulating Hormone (FSH) prescribed for ovarian stimulation, is individualised with a dosing~     regimen that is based on two parameters: the body weight and the level of a hormone, the Anti~     Müllerian Hormone, (AMH), a parameter used to predict how the ovaries will respond to the~     ovarian stimulation.~   "
13223|NCT03393767|"~     The purpose of the study is to detect persisting or early new activity of choroidal~     neovascularization (CNV) due to age related macular degeneration (AMD) during the first 12~     months following the first ranibizumab dose at baseline as assessed by weekly high resolution~     optical coherence tomography (OCT). Detection of persisting or new signs of CNV activity at~     OCT triggers further ranibizumab treatments considering that any ranibizumab injections can~     maximally be applied as often as 2-weekly.~   "
13224|NCT03393754|"~     This study is a double-blind randomized controlled trial designed to establish the~     non-inferiority of Sci-B-Vac™ compared to Engerix-B® in adults ≥ 18 years old and the~     superiority of Sci-B-Vac™ compared to Engerix-B® in ≥ 45 years old.~   "
13225|NCT03393741|"~     Eligible subjects will be assigned to study treatment arms by their treating oncologist,~     rather than by the study. The drug, dose, and schedule of administration will be determined~     by the treating physician per NCCN guidelines for standard of care chemotherapy regimens for~     recurrent or metastatic breast cancer. Study treatment arms include: Taxane (nab-paclitaxel~     or paclitaxel), Eribulin, Vinorelbine, Ixabepilone, or the control arm (non-microtubule~     targeted chemotherapies such as doxorubicin, carboplatin, or gemcitabine).~   "
13226|NCT03393728|"~     Objective: The aim of our study was to evaluate the short term effects of Propanolol on heart~     rate variability in patients with hyperthyroidism.~      Design: In ten patients newly diagnosed as having hyperthyroidism and naïve of all treatment~     specific for hyperthyroidism, we evaluated the short term effects of Propanolol on heart rate~     variability (HRV).~      Methods: We measured heart rate variability by power spectral analysis during 2 hours of rest~     and during Ewing's tests before and after the administration of Propanolol 40mg/12 hours~     orally for 72 hours.~   "
13227|NCT03393715|"~     We assessed the influence of time of administration of ACE inhibitors on circadian blood~     pressure control in sub Saharan type 2 diabetes patients with stage 1 hypertension over 56~     days as first line treatment.~   "
13228|NCT03393702|"~     The study is performed in patients aged 5-18 years after thoracic surgery. The primary aim of~     this study is to determine whether the use of gabapentin will improve postoperative~     multimodal analgesia and reduce consumption of ropivacaine with fentanyl or morphine in~     children and adolescent after the Ravitch procedure and thoracotomy. Secondary aims are to~     evaluate whether use of gabapentin reduces pain and anxiety scores, decreases postoperative~     nausea and vomiting, and improves patient satisfaction.~   "
13229|NCT03393689|"~     The aim of this non-randomised, prospective study is to investigate the applicability and~     prognostic value of angiogenesis PET/MR with the radioligand 68Ga-NODAGA- E[c(RGDyK)]2 in~     patients with sporadic Vestibuarl Schwannomas.~   "
13230|NCT03393676|"~     The purpose of this study is to investigate the effects of preoperative pain on POCD in elder~     patients.~   "
13245|NCT03393481|"~     The purpose of the study is to find out whether MAA868, is able to prevent blood clots~     following your medical condition (surgery for knee replacement)~   "
13231|NCT03393663|"~     Chronic kidney disease has become an important Public Health issue in most developed and~     developing countries, with increasing incidence and prevalence rates. The cost associated~     with chronic kidney disease patients is very high, derived from renal replacement therapy and~     the cost associated with the high cardiovascular risk of this population. Primary and~     secondary preventive measures are imperative. In this sense, the comprehension of mechanisms~     and biomarkers associated with CKD progression and mortality risk in this population is an~     important area of research. Cohort studies are important tools for testing risk factors and~     biomarkers. Currently, CKD cohorts, particularly of those not on dialysis, are few and~     restricted to North America and Europe.~      The present study established a cohort of 454 CKD participants (not on dialysis) in Sao~     Paulo, Brazil, who will be followed for 7-10 years. Baseline data collection was wide,~     including medical history, diet (food frequency questionnaire), calcium score,~     echocardiography, pulse wave velocity, cardiac frequency variability, carotid intimal media~     thickness, retinography, and an extensive biobank. Follow-up is ongoing and made through~     annual telephone interviews including questions on death, hospitalizations, and need of renal~     replacement therapy (RRT). Vital status is investigated periodically by a hot-pursuit~     strategy.~   "
13232|NCT03393650|"~     Investigate the effect of 12 weeks mixed power training (power and functional exercises)~     combined with a protein supplementation (30g/d) or not (placebo) on physiological~     characteristics of muscle and functional capacities in elderly men.~   "
13233|NCT03393637|"~     The M-O-M-S project evaluates the effectiveness of the M-O-M-S program for improving birth~     outcomes and maternal-infant attachment and role satisfaction in a large military sample.~   "
13234|NCT03393624|"~     Periorbital hyperchromia (POH) or periorbital hyperpigmentation, commonly known as dark~     circles, is a relatively common condition and a frequent reason for dermatological~     consultation. It is defined as brown-colored pigmentation, ranging from light to dark, which~     mainly involves the lower eyelids. POH affects individuals over a wide age range, including~     both sexes and all ethnicities, and is associated with a tired and aged facial appearance.~     The most commonly affected people are those with the highest skin phototypes. Although the~     prevalence is similar between sexes and age groups, POH is a more frequent complaint in~     women. The dark circles characteristic of POH can negatively impact patients' quality of~     life, although it is not a condition associated with morbidity. Popularly it is believed that~     the poor quality of sleep is a factor responsible for its appearance, but there is no~     consistent data in the literature that prove this.~   "
13235|NCT03393611|"~     This pilot study is designed to evaluate outcomes with the combination of CPX-351 salvage~     therapy and haplo-cord graft stem cell transplantation for subjects with relapsed or~     refractory AML or myelodysplastic syndrome.~   "
13236|NCT03393598|"~     This study aims to investigate the preparation of the recipient site prior to autologous fat~     grafting (AFG) using different methods.~   "
13237|NCT03393585|"~     Respiratory rate is an important predictor for many clinical outcomes in Emergency Medicine.~     Nevertheless it's measurement is often omitted as it is time-consuming and cumbersome. It is~     the only vital sign that is not routinely assessed by a device. In a pilot study was showed~     that a camera based monitoring system measures reliably respiratory rates in healthy~     volunteers.~      The goal of this study is to test the accuracy of the same system in real patients in the~     triage setting of an Emergency Department (ED).~   "
13238|NCT03393572|"~     The purpose of this study is to compare between the addition of Mg sulphate or Nalbuphine to~     intraperitoneal bupivacaine installation in laparoscopic hysterectomy for postoperative pain~     control and their relative adverse effects.~   "
13239|NCT03393559|"~     The aim of this study is to evaluate the effect of leg elevation on the prevention of~     intraoperative hypotension during shoulder surgery in the Beach-chair position. patients~     undergoing shoulder surgery in the Beach-chair position will be randomly assigned to Group L~     (with leg elevation) or Group C (no intervention). The primary outcome is the incidence of~     intraoperative hypotension (mean blood pressure < 60mmHg or systolic blood pressure < 80% of~     baseline). Secondary outcomes are the incidence of intraoperative cerebral desaturation~     (cerebral oxygen saturation < 80% of baseline, longer than 30 seconds), total amounts of~     administered inotropic agents, and systolic blood pressure, heart rate, and cerebral oxygen~     saturation at various time points.~   "
13240|NCT03393546|"~     Pain is considered as one of the most important causal factors of behavioral and~     psychological symptoms in patients Alzheimer's disease and related disorders (ADRD). The~     investigators plan to examine the effectiveness of pain relief, pain sensory change (measured~     by quantitative sensory testing) and immune biomarkers change (measured by serum biomarkers)~     after the auricular point acupressure (APA). A waitlist and education control will be used to~     examine the feasibility of a 4-week APA intervention. The investigators will also explore~     potential analgesic pathways and underpinnings of APA on pain relief.~   "
13241|NCT03393533|"~     Extraction of lower third molars semi-included or included is one of the most performed~     procedures in oral surgery, and inherent to the procedure there is a postoperative~     inflammatory response. Among the factors most routine to this response are pain, edema and~     trismus. The therapy taping has advantages in its use in the physiotherapy of several~     specialities, leading to the correction of muscular functions, reduction of edema, muscular~     spasms and reduction of pain. Thus, the objective of this split mouth, randomized, blind,~     clinical trial will be to evaluate the postoperative period of 32 third molars in the~     patients from the São Paulo State University (Unesp), Institute of Science and Technology,~     São José dos Campos, Brasil. These evaluations will be performed on the third and seventh~     days after the extraction, where the patients will be analyzed by evaluator who will measure~     the edema, the opening of the mouth (evaluation of muscle spasm) and collect the pain table~     delivered in the immediate postoperative period, comparing thus, the benefit of therapeutic~     banding in the postoperative period of the extraction of lower third molars. The analogue~     pain scale (VAS), together with the Ustün et al. (2003) and the millimeter rule will be used~     to compare the data and the results will be submitted to descriptive statistics and compared~     by means of the statistical analysis of variance (ANOVA) and Tukey test with significance~     level of 5%.~   "
13242|NCT03393520|"~     This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786~     compared to placebo, for the treatment of agitation in participants with dementia of the~     Alzheimer's type.~   "
13248|NCT03393442|"~     Purpose: To determine whether patients at high risk to develop breast cancer having received~     at least 6 cumulative dosages of macrocyclic Gd-based contrast media in the context of breast~     cancer screening by means of contrast-enhanced MRI.~      Methods: Diagnostic study encompassing two arms: first, 50 patients having received ≥6~     dosages of macrocyclic Gd-based contrast media in the course of MRI-based breast cancer~     screening will undergo brain MRI assessment for signal alterations due to Gd-deposits. The~     second arm consists of 50 healthy volunteers that never received Gd-based contrast agents,~     and undergoes the same brain MRI assessment as the patient-based arm 1 of the study. Signal~     intensities will be compared to assess the potential presence or absence of macrocyclic~     Gd-based contrast agent deposits in the brain.~      In case of presence of signal alterations in arm 1 these will be further stratified by number~     of previously administered macrocyclic Gd-contrast agent doses.~      Projected outcome: High cumulative dosages of macrocyclic Gd-based contrast agent either~     result or do not result in brain MRI signal alterations in healthy women participating in a~     high-risk screening program for the early detection of breast cancer that necessitates~     Gd-contrast agent enhanced breast MRI at regular intervals.~   "
13249|NCT03393429|"~     Work place related (lower) back pain in medical personnel is limiting to workability.~      Even though occupational prevention programs are increasingly established, data on the~     effectiveness of training interventions offered at work-sites is largely missing.~      In this randomized, investigator-blind, controlled feasibility study we aim to compare the~     effectiveness of device assisted training therapy in comparison to a general recommendation~     to stay active or group gymnastics in terms of pain frequency and intensity (main outcome).~     Additional outcome variables are: quality of life, psychological well-being, work efficiency,~     of sick-leave days.~      Eligible employees (2 x 30) of the General Hospital of Vienna (AKH) over the age of 45 years~     suffering from (lower) back pain (>30 days/last year) of intensity ≥ 3 (numeric scale 0-10)~     will be included in two parallel groups. Group I starts with a device (DAVID) assisted~     training (40 training sessions; 2x / week) of the core trunk musculature. Group II gets~     instructions and an advice on how to stay active during the first 6 months. Assessment will~     be conducted before and after these 6 months; then groups are switched, thus, study subjects~     act as their own controls.~   "
13250|NCT03393416|"~     This study evaluate the safety and tolerance of MASCT-I(multiple-antigen specific cell~     therapy) combined with PD1 antibody in patients with advanced gastric cancer who failed in~     first-line chemotherapy. The study is divided into three stages: the first, second stage is~     the stage of the dose climbing, and the third stage is the dose expansion stage. The patients~     would be treated with MASCT-I single drug therapy, MASCT-I+ low dose PD1 antibody therapy,~     and MASCT-I+ high dose PD1 antibody therapy.~   "
13251|NCT03393403|"~     Using random case assignment to investigate the analgesic and sedative effect of intravenous~     dexmedetomidine and dexmedetomidine as a local anesthetic adjuvant in ultrasound-guided~     subcostal TAP block in gastric cancer patient undergoing gastrectomy or partial gastrectomy.~   "
13252|NCT03393390|"~     The purpose of this study is to learn more about the functioning of particular types of~     regions of the brain, specifically, those related to externalizing disorders such as~     Attention Deficit Hyperactivity Disorder (ADHD), Oppositional Defiance Disorder (ODD), and~     Conduct Disorder (CD). Brain function of children and adolescents with externalizing~     disorders such as ADHD, ODD, and CD will be compared to the brain function of those without.~     Functional Magnetic Resonance Imaging (fMRI) will be used to monitor brain activity at work~     and at resting states.~   "
13253|NCT03393377|"~     The study was designed to test whether short-term treatment with a very low-dose combination~     of fluvastatin and valsartan could induce improvement of endothelial function, arterial~     stiffness, vascular inflammation, oxidative stress and expression of protective genes in~     subjects with moderate cardiovascular risk.~   "
13254|NCT03393364|"~     Goal of this study is to evaluate how pain is controlled after outpatient urologic surgeries.~     Patients will receive either opioid pain medication or non-opioid medication for pain~     control. A survey will be conducted at the post-operative appointment to evaluate for pain~     control.~   "
13255|NCT03393351|"~     This study aims to evaluate a theoretically and empirically grounded implementation program~     designed to foster shared decision-making in routine cancer care. The intervention program~     consists of several components (e.g. training for health care professionals, patient~     empowerment strategies) that will be rolled out in three clinics at a comprehensive cancer~     center in Germany.~   "
13256|NCT03393338|"~     The overall goal of this randomized controlled trial is to test the efficacy of DM I-TEAM~     (Diabetes Interprofessional Team to Enhance Adherence to Medical Care) to reduce emergency~     department (ED) visits and hospitalizations over 12 months in older African Americans (AAs)~     with diabetes mellitus (DM). DM I-TEAM is a multidisciplinary behavioral intervention that~     comprises a community health worker (CHW), the participant's primary care physician (PCP), a~     diabetes nurse educator, and a clinical geriatric pharmacist. In DM I-TEAM, the CHW conducts~     in-home sessions to: (1) provide diabetes education, (2) facilitate adherence to diabetes~     self-management behaviors (e.g., medication adherence glucose monitoring, diet, exercise);~     and (3) build trust between patients and their primary care team. This is accomplished by:~     (1) using culturally relevant diabetes educational materials; (2) facilitating telehealth~     visits with the participant's PCP and the diabetes nurse educator via JeffConnect; and (3)~     having the study pharmacist review participants' medication regimens to identify potentially~     inappropriate medications, simplify medication regimens if possible, and to reduce medication~     side effects.~   "
13257|NCT03393325|"~     A 4-8 week observational feasibility study of the use of the use of Tadalafil-Delivra in the~     treatment of Reynaud's Phenomena (RP).~   "
13269|NCT03393169|"~     The local database results from a joint initiative of anesthesic, cardiology and cardiac~     surgery departements.Its purpose is to record in an exhaustive fashion all the interventions~     of cardiac surgery performed under extracorporeal circulation in adults at Bichat~     hospital.This database includes the preoperative characteristics of the patients, the type of~     surgery, the post-operative complications and the in-hospital mortality. The purpose of this~     observational study is to evaluate in-hospital morbidity and mortality for all types of~     cardiac surgery interventions and to analyze it according to the characteristics of the~     patients and the type of intervention.~   "
13258|NCT03393312|"~     The investigators are interested in investigating whether transcranial direct current~     stimulation (tDCS0 over the dorsolateral prefrontal cortex (DLPFC) can alter behaviour and~     neural activity in subclinical depression. tDCS is a neuromodulation technique that uses weak~     electrical current to increase (anodal stimulation) or decrease (cathodal stimulation) the~     probability of brain activity in the stimulated region. A growing body of evidence indicates~     that repeated administration of prefrontal tDCS can ameliorate symptoms of depression. A main~     characteristic of depression is that patients show a bias towards processing negative~     relative to positive information. Previously, we have demonstrated that a single session of~     prefrontal tDCS was associated with an increased learning rate for positive information in~     healthy adults. Here, the researchers will examine whether similar behavioural effects are~     found in individuals with subclinical depression when applying prefrontal tDCS. In addition,~     investigators will use neuroimaging measures to investigate how tDCS affects neural activity~     during a reward-learning task. The findings of the study will contribute to the understanding~     of the cognitive and neural effects of prefrontal tDCS in subclinical depression. It is~     predicted that tDCS will increase learning rates for positive information by altering~     activity in the prefrontal cortex and anterior cingulate cortex. The ultimate aim, to be~     explored through further studies, is to understand and improve how tDCS might be used in the~     treatment of depressive disorders.~   "
13259|NCT03393299|"~     Assess the impact of the systematic use of STOPP/START tool during medication conciliation on~     the evolution of hospitalised elderly people's quality of life at 2 months.~   "
13260|NCT03393286|"~     The aim of this proposal is to evaluate the causal relationship between Zika virus (ZIKV)~     infections in pregnancy and congenital malformations. We will estimate the absolute and~     relative risks of congenital malformations and other adverse outcomes of pregnancy among~     women who become infected with ZIKV during pregnancy compared to uninfected pregnant women,~     also leading to further validation of the Congenital Zika Syndrome.~   "
13261|NCT03393273|"~     This is a multicenter, open-label phase II study, assessing the efficacy of elotuzumab in~     elderly patients with multiple myeloma undergoing peripheral stem cell autologous graft~   "
13262|NCT03393260|"~     Patients with cancer or hematological malignancy are susceptible to present acute~     complications linked to their disease or to their specific treatments (dyspnea, sepsis, coma,~     hemorrhagic syndrome). Emergency physicians are in first line when these complications arise~     and have to face with some complex situations in which informations about patient malignancy~     or prognosis may be lacking. Nowadays, there is very few epidemiological data published~     concerning how cancer patient use Emergency Departments (EDs) and cancer patient care~     delivery in the EDs.~      Thus, an observational multicenter prospective cross-sectional study is conducted to study~     the prevalence of cancer patients admitted to French EDs, and to describe the different~     reasons for cancer patients to seek care in EDs with their prevalence and underscore those~     linked to cancer or treatment complication~   "
13263|NCT03393247|"~     This study aim to identify the therapeutic effect of azathioprine during infliximab(IFX)~     treatment in Crohn`s disease (CD).Half of patients will receive azathioprine and infliximab~     combination therapy at the same time. The other half patients will be given infliximab~     therapy first and then receive azathioprine 14 weeks later.~   "
13264|NCT03393234|"~     The purpose of this study was to research on the safety and feasibility of ISR combined with~     low energy X ray intra-operative radiotherapy for the patients with local advanced rectal~     cancer.~   "
13265|NCT03393221|"~     While the prevalence of overweight and obesity among children and adolescents has plateaued,~     national data indicate that approximately 35% of children and adolescents continue to~     struggle with overweight/obesity. While considerable attention has been given to~     comprehensive behavioral interventions to address obesity in children, there is less~     empirical evidence demonstrating efficacy of interventions with adolescents. Additionally,~     there is great variability and limited impact of adolescent weight control interventions~     which may be attributable to the failure of these interventions to explicitly address emotion~     regulation abilities that are necessary for weight loss. Notably, adolescents with poorer~     general emotion regulation have been found to consume more snack/junk food and report greater~     amounts of sedentary behavior. Poor emotion regulation among adolescents has also been~     associated with more rapid weight gain and greater BMI. This project adapts a previously~     validated Emotion Regulation intervention (TRAC) for at-risk adolescents, targeting sexual~     risk reduction, to focus on weight loss among a sample of overweight and obese adolescents~     (ages 12 to 18). While sexual risk and weight management are distinct health behaviors, this~     same model of emotion regulation could be applied to overweight/obese adolescents attempting~     to lose weight. In fact, data from overweight/obese adolescents attending a past outpatient~     weight management program (N=124) indicate that 82% of these youth report emotion regulation~     scores that are comparable to youth with significant mental health problems. Furthermore,~     higher levels of emotional dysregulation was associated with greater BMI within this same~     sample. These data suggest that emotion regulation is related to health decision making and~     will be relevant to the majority of overweight/obese adolescents seeking to lose weight. The~     current study will be carried out across Phase 1a and 1b. During Phase 1a, the initial~     acceptability and feasibility of the adapted intervention (HEALTH TRAC) with eight~     adolescents in an open pilot trial will be evaluated. During Phase 1b, 48 adolescents between~     the ages of 13-17 years will be randomized to receive either the HEALTH TRAC or standard~     behavioral weight control intervention (SBWC) and examine the impact on emotion regulation~     abilities and BMI status over an eight-month period. The information gained in this project~     will improve understanding of strategies to improve weight loss outcomes among~     overweight/obsess adolescents and how improving emotion regulation abilities can enhance~     these interventions.~   "
13266|NCT03393208|"~     The study will assess the bioequivalence between single doses of glucophage immediate release~     (GIR) test tablets and GIR reference tablets under fed and fasted state in healthy subjects.~   "
13267|NCT03393195|"~     This is a randomized controlled trial studying the effects of time-restricted feeding (TRF)~     on weight loss in obese humans. Obesity is the number one risk factor for type 2 Diabetes~     Mellitus (T2DM), and numerous studies demonstrate that weight loss is an effective strategy~     to prevent T2DM and improve the metabolic health of people diagnosed with T2DM.~     Unfortunately, classical calorie restriction diets often fail to produce long-term weight~     loss due to low compliance, reduced resting metabolic rate (RMR), and other factors.~     Therefore, novel dieting techniques must be explored in order to successfully treat obesity~     and prevent T2DM. Studies in mice provide compelling evidence that feeding/fasting cycles can~     be altered to produce beneficial effects on weight loss and metabolic health markers in the~     absence of calorie restriction. Limited research in human subjects suggests that this feeding~     paradigm may translate to human health as well, however, more research needs to be done in~     order to confirm this hypothesis. This study will determine if TRE can lead to weight loss in~     obese human subjects. Secondary outcomes include changes in body composition, HOMA-IR,~     hormonal and biochemical serum markers, RMR, and total energy expenditure (TEE).~   "
13268|NCT03393182|"~     The present randomized study is designed to compare the quality of life between the patients~     undergoing laparoscopy-assisted and totally laparoscopic distal gastrectomy for gastric~     cancer, and therefore to evaluate the superiority of totally laparoscopic distal gastrectomy~     to laparoscopy-assisted distal gastrectomy.~   "
13271|NCT03393143|"~     Back pain is one of the most common reasons patients seek medical care, and it can have a big~     impact on patients' quality of life and functioning. Patients and providers are becoming more~     frustrated with common back pain treatments like the long-term use of opioid medications and~     steroid injections, which have been shown to have limited long-term impact on patients' pain~     and day-to-day functioning and can have safety risks.~      The State of Oregon is in the process of changing what back and neck pain treatments they~     will cover for its Medicaid enrollees. This started to affect those insured by Medicaid in~     July 2016 and will be completely implemented by January 2018. These changes will end payments~     for treatments like chronic opioid therapy and injections. They also increase the use of~     nondrug treatments, such as cognitive behavioral therapy, supervised exercise therapy,~     intensive interdisciplinary rehabilitation, physical/occupational therapy, and complementary~     medical approaches (acupuncture, osteopathic/chiropractic manipulation, yoga, and massage).~     While experts agree that opioid use must be reduced, Oregon is among the first states to try~     such strong measures to promote nondrug treatments and prevent the use of chronic opioid~     treatment for back and neck pain.~      The Oregon Medicaid reimbursement changes for back and neck pain treatment create the~     opportunity for a natural experiment. In this mixed-methods, observational study, we will~     evaluate the impact of the reimbursement changes by comparing outcomes among patients with~     back pain in Oregon who will have access to these expanded nondrug treatments to similar~     patients seen in comparable clinics in California where expanded services for back and neck~     pain are not covered by the type of comprehensive payer incentive undertaken in Oregon.~      Specifically, we will use electronic health record, Medicaid claims data, and data obtained~     from a longitudinal patient survey to assess the impact of the changes on:~        -  Opioid prescribing~        -  Patients' use of pain-related health care services~        -  Patients' pain severity, pain related functioning, and satisfaction with care~        -  Adverse events, such as the use of illegal and other recreational drugs (While we expect~          the Oregon Medicaid change to result in many positive changes, limiting the use of~          opioids and pain reducing procedures like injections may motivate some individuals to~          use drugs that were not prescribed by their doctor.)~      In addition, we will use qualitative research methods to characterize the facilitators and~     barriers experienced by patients, health care providers, and clinic administrators and staff~     in adopting the Medicaid reimbursement changes and their satisfaction with the constellation~     of available and utilized services.~      Thus, this study has three components: 1) patient survey, 2) electronic health record-based~     study, and 3) qualitative evaluation.~   "
13272|NCT03393130|"~     The current central dogma of long-term cognitive impairment after intensive care admission~     suggests an underlying neuroinflammatory dysregulation affecting neuronal function. This~     pathological process has not been fully elucidated and there has been little research into~     its genetic associations.~      Alzheimer's disease (AD) causes cognitive impairment through a process of abnormal beta~     amyloid deposition and neuronal death through localised activation of the innate immune~     system. It is the most prevalent disease affecting cognition. The Apolipoprotein E (APOE)~     gene is implicated in the progression of late-onset Alzheimer's disease and is a recognised~     neuroinflammatory modulator. It is possible that young individuals exposed to high levels of~     inflammation may experience an acceleration of this process. This study sets out to look for~     an association between APOE-∈4 possession and poor cognitive outcome after a major burn~     injury and intensive care admission.~   "
13273|NCT03393117|"~     The purpose of this study is to determine the most effective way to control post-operative~     breast pain for patients undergoing a unilateral, immediate breast reconstruction.~   "
13274|NCT03393104|"~     Low back pain (LBP) is the leading cause of disability globally with increasing concern about~     its impact in low-income countries especially where health care services are less extensive.~     This is true especially to developing nations like Africa where prevalence of LBP seems to be~     on the increase and more specifically, Nigeria is no exception. According to previous studies~     in Nigeria, the burden of LBP among rural Nigerians is greater compared to urbanites but~     unfortunately lack access to physiotherapy services. While both biomechanical and~     psychosocial factors are known to be important issues, current approach to LBP mainly focus~     on purely biomedical model in this context.~      The purpose of this study is to assess the combined effects of supervised graded motor~     control exercise (MCE) and patient education (PE) program in the management of chronic~     nonspecific LBP (CNLBP) among rural community-dwelling individuals.~   "
13275|NCT03393091|"~     Perioperative anaphylaxis is associated with significant morbidity and mortality. Most~     textbooks describe it as a rare event of the order of 1 in 10 to 1 in 20,000 general~     anaesthetic cases. However, a recent study in the United Kingdom suggested that 1 in 350~     cases have features suspicious of perioperative anaphylaxis. This study suggests that~     perioperative anaphylaxis may be under recognised and under reported.~      When perioperative anaphylaxis is recognised, it would be ideal to carry out investigations~     firstly to confirm the diagnosis of anaphylaxis and secondly to identify the causative agent.~     The latter can be difficult in the context of anaesthesia where the patient is exposed to~     several drugs and other reagents in a short space of time.~      One of the interesting aspects of perioperative anaphylaxis is that there is variability in~     its epidemiology between different countries, for example between the United Kingdom, France,~     Scandinavia and Australia and New Zealand. There are currently no data from Egypt to include~     in such comparisons and to inform clinical practice.~      As well as being at risk if a drug allergen is not identified, patients can also be at risk~     from an incorrect allergy label. The most common example of this is penicillin allergy where~     fewer than 10% of patients with a history of penicillin allergy are found to be allergic.~     Incorrect penicillin allergy labels are potentially harmful for patients attending for~     surgery because the label independently increases the risk of developing infection to~     resistant organisms, longer hospital stays and mortality.~   "
13276|NCT03393078|"~     To investigate the treatment effect of repetitive transcranial magnetic stimulation on~     Obsessive-compulsive disorder, and the underlying neural mechanism by functional MRI.~   "
13277|NCT03393065|"~     In the Intensive Care Unit (ICU) this bedside method of assessing lung congestion could be~     useful in a better management of the critically ill patients with a wide range of respiratory~     failure causes (Acute Respiratory Distress Syndrome, COPD, acute pulmonary edema, pneumonia~     etc.). Fluid management is a key issue in the ICU where patients are either hemodynamic~     unstable and/or mechanically ventilated. A randomized study is proposed where in the~     interventional arm the fluid management (volume replacement, diuretics, use of vasopressors)~     will be guided using the BLS as a sign of pulmonary congestion.~   "
13278|NCT03393052|"~     This randomized, multicenter, prospective study seeks to compare left radial and femoral~     access during cardiac catheterization of patients with prior history of CABG surgery, with~     the primary objective of demonstrating that the two access techniques do not differ in the~     net procedure time (non-inferiority study) expanding the documented benefits of radial access~     to this group of patients.~   "
13391|NCT03391583|"~     The study will ask the question as to whether or not it is possible to deliver education~     material to patients with a mild traumatic brain injury in a consistent matter. The question~     will be asked as to whether an educational intervention decreases symptom reporting~     specifically looking at headache symptoms. Half of the patients will receive the current~     standard of care in the tertiary clinic they have been referred to while the other half will~     also receive the current standard of care with the addition of targeted headache educational~     material at various time points.~   "
13279|NCT03393039|"~     Binge-eating is characterized by recurrent episodes of eating large amounts of - typically~     high calorie - foods, eating much more rapidly than normal and until feeling uncomfortably~     full, as well as feeling disgusted with oneself, depressed, or guilty after those episodes.~     Two eating disorders are characterized by binge-eating as central diagnostic criteria,~     binge-eating disorder (BED) and bulimia nervosa (BN). Binge-eating episodes in BN, but not~     BED, are typically followed by compensatory mechanisms such as self-induced vomiting, and BED~     is typically associated with obesity, while BN is not. Behavior studies such as ecological~     momentary assessment (EMA) research of affect in an individual's naturalistic environment~     have shown that negative affect and negative urgency (the tendency to act rashly when~     distressed) often precede binge-eating.~      The Investigators want to answer the following questions: Can negative affect in BN and BED~     be linked to 1) altered dopamine related brain reinforcement learning, 2) to food value~     computation and cognitive control circuit function, and 3) can dopamine related brain~     activation predict eating and negative affect, indicating a brain based neurobiological~     vulnerability. Answering those questions will help to define binge-eating based on regulation~     of brain reward, cognition, and emotion circuit function and point toward potential~     psychopharmacological interventions to normalize brain function and behavior.~   "
13280|NCT03393026|"~     The study evaluates the effectiveness and safety of Lurasidone in subjects with schizophrenia~     over a period of 6 weeks.~   "
13281|NCT03393013|"~     This is a Phase 1b/2, multi-center study in which patients will receive KZR-616, administered~     as a subcutaneous injection weekly for 13 weeks.~      The study consists of 2 parts. Part 1, the Phase 1b, is an open-label multiple dose~     escalation study to evaluate the safety and tolerability of KZR-616 in patients with systemic~     lupus erythematosus (SLE) with and without nephritis. Part 2, the Phase 2, is a randomized,~     placebo-controlled, double-blind study to evaluate the safety and efficacy of KZR-616 in~     patients with active proliferative lupus nephritis (LN).~   "
13282|NCT03393000|"~     Open-label, randomized, controlled, phase 3 safety and efficacy registration trial.~      Subjects will be randomized at baseline to the standard of care for first-line treatment of~     glioblastoma plus Trans Sodium Crocetinate (TSC) or the standard of care.~      The standard of care for GBM will consist of temozolomide plus radiation therapy for 6 weeks~     followed by 28 days of rest followed by 6 cycles of post-radiation temozolomide treatment.~   "
13283|NCT03392987|"~     GSK2696274 is autologous cluster of differentiation 34+ (CD34+) cells transduced with~     lentiviral vector containing human arylsulfatase A (ARSA) complementary deoxyribonucleic acid~     (cDNA) used for the treatment of MLD. MLD is an autosomal recessive lysosomal storage~     disorder (LSD) characterized by severe and progressive demyelination affecting the central~     and peripheral nervous system. This study will assess safety and efficacy of treatment using~     cryopreserved formulation of GSK2696274 in pediatric subjects with pre-symptomatic Early~     Onset MLD (Late Infantile (LI) to Early Juvenile (EJ) MLD). Up to 10 subjects may be included~     in the study. A minimum of 3 subjects are planned to assess the primary endpoint. Subjects~     will be followed up for a minimum period of 8 years post treatment.~   "
13284|NCT03392974|"~     This clinical trial is being conducted to learn more about a potential treatment~     (valoctocogene roxaparvovec) for people with severe hemophilia A. This research study will~     test and confirm the safety and effectiveness of the 4E13 vg/kg dose of the study drug~     (valoctocogene roxaparvovec) that contains the correct gene to make Factor VIII so that the~     body can make its own Factor VIII that functions properly. Only one dose of valoctocogene~     roxaparvovec is being given in this study, and this dose has been previously studied in~     another clinical trial in patients with hemophilia A. This is a phase 3 study which is meant~     to show that the study drug is safe and works to help treat hemophilia A. The study will see~     if liver cells are able to make Factor VIII that functions properly after receiving this~     study drug. The study will also examine the effects that the study drug has on how much~     Factor VIII concentrates patients have to inject into their veins and on their bleeding~     episodes after the study drug has been administered. Finally, the study will see if and how~     the body responds to the study drug - for example, whether liver cells become inflamed or~     whether the body makes antibodies (something the immune system makes to protect itself~     against things like bacteria and viruses) against the vector or the new Factor VIII gene.~   "
13285|NCT03392961|"~     A study to evaluate the PK and PD of oral IN-105 (Insulin Tregopil) w.r.t. time of dosing~     prior to meal, duration between meals and type of meal .~   "
13286|NCT03392948|"~     Approximately 5 to 8% of patients undergoing percutaneous coronary interventions requires~     chronic anticoagulant therapy due to atrial fibrillation or other clinical entities. There~     are many possible different combinations of the antithrombotic therapy after stent~     implantation in these patients.~      Aim of this observational study is to evaluate the real world antithrombotic treatment in~     patients requiring anticoagulant therapy undergoing stent implantation and to compare the~     clinical outcome of patients treated with new oral anticoagulant drugs compared to warfarin.~      The study is prospective, performed in different Italian hospitals and aimed to enroll 1080~     patients with a 1 year follow up~   "
13287|NCT03392935|"~     This study is to find a more effective treatment for itchy, painful or unsightly~     dermatofibromas, that will improve symptoms of itch and/or pain and/or improve the appearance~     of dermatofibromas. This is an open-label study where subjects will receive a laser treatment~     at week 0, and week 4, and then 2 additional follow-up visits. Photographs will be taken at~     each visit and rated by blinded reviewers after the study to determine efficacy.~   "
13288|NCT03392922|"~     One-lung ventilation (OLV) is required for the most thoracic surgery to facilitate surgical~     visualization by collapsing the lung. The double-lumen tube (DLT) and Uniblocker are the~     commonly used device for OLV.The objective of our study was to comparison the safety and~     effectiveness of the intubation of the Left-sided Double-lumen Tube and the Uniblocker under~     the guidence of chest computed tomography (CT) image.~   "
13392|NCT03391570|"~     The purpose of this study is to compare postoperative pain following COX-2 and prostanoids~     expression in women who underwent laparoscopic surgery for female genital disease in order to~     evaluate the effect of COX-2 on local inflammation, COX-2 and prostanoids expression followed~     by exposure time to carbon dioxide(CO2) gas, and degree of postoperative pain.~   "
16372|NCT03352661|"~     The purpose of this study is to evaluate if there are differences in oocyte quality depending~     on whether these oocytes come from an ovary in contact with an endometrioma.~   "
13289|NCT03392909|"~     Recessive dystrophic epidermolysis bullosa (RDEB) is an incurable, devastating, inherited~     skin disease caused by mutations in the COL7A1 gene that encodes for type VII collagen (C7),~     the major component of anchoring fibrils (AFs), structures that mediate epidermal-dermal~     adherence. Thirty percent of RDEB patients have nonsense mutations. The investigators~     recently demonstrated in 5 such patients that intradermal and topical gentamicin induced~     read-through of their nonsense mutations and created robust and sustained new C7 and AFs at~     the dermal-epidermal junction (DEJ) of their skin and also stimulated wound closure and~     reduced new blister formation. No untoward side effects occurred. Herein, the investigators~     propose evaluating the safety and efficacy of intravenous gentamicin in these patients. In~     theory, this intravenous administration has the possibility of treating simultaneously all of~     the patients' skin wounds. The milestones will be increased C7 and AFs in the patients' DEJ,~     improved EB Disease Activity Scores, and absence of gentamicin side effects.~   "
13290|NCT03392896|"~     This is a double-blind, placebo-controlled, dose escalation trial of DCR-PHXC in Normal~     Healthy Volunteers (NHVs) and patients with Primary Hyperoxaluria (PH). Once safety has been~     established in NHV, PH patients with a confirmed diagnosis of PH1 and PH2 will be enrolled~     across multiple dosing cohorts. The study design will allow enrollment of PH patient cohorts~     at a given dose level once safety has been demonstrated in NHV at that dose level. The study~     will be conducted in two parts: Part A: Single ascending dose (SAD) in NHV; Part B: SAD in~     patients with PH1 and PH2 (lagging Part A by 1 dose level cohort).~   "
13291|NCT03392883|"~     Conduct systematic, multi-site mental health implementation research in both rural and urban~     primary care settings with a broad group of stakeholders in the US and Latin America.~   "
13292|NCT03392870|"~     Clinical trial without drug, randomized: Comparison of a specific and integrative clinical~     protocol for young adults with autism to usual treatment. It will include both low and~     high-functioning participants.~   "
13293|NCT03392857|"~     The purpose of this multicentric study is to evaluate the perception of the quality of the~     end of life in intensive care units seen from the side of the caregivers, trough the CAESAR~     scale.~   "
13294|NCT03392844|"~     The primary objective of this study is to evaluate the impact of provision of a child bed~     through the Beds for Kids program on objectively measured child sleep, and on daily child~     behavioral functioning and caregiver functioning over a 14-day period for preschool-aged~     children.~   "
13295|NCT03392831|"~     Infusion therapy comprises the parenteral administration of solutions, through peripheral or~     central vascular access. Some solutions and drugs are highly irritating to the vascular~     endothelium and therefore cannot be administered in peripheral vessels, because increase the~     risk of phlebitis and/or tissue necrosis. Thus, the alternative is the central venous~     catheter (CVC) where the access can be by direct puncture of a central vessel or peripheral~     vessel puncture with progression of the catheter until central positioning, through a~     peripherally inserted central catheter (PICC).~      We must take into account that indication, insertion, handling and maintenance must be~     balanced with risks, benefits and costs. The insertion and maintenance of both catheters are~     not free of complications. Among the most frequent are: Infection, thrombosis, lumen~     occlusion and accidental early removal of the catheter. This often implies in the need for~     new vascular access, impacting on morbidity and increased treatment costs.~      The PICC has some advantages over CVC, for example: avoids repetitive punctures and~     consequently decreased handling/pain; a lower risk of infection; avoids the use of venous~     dissections; reduces the risks of pneumothorax/hemothorax; reduces the risk of infiltration,~     extravasation, necrosis tissue and chemical phlebitis. Further, the PICC can be used as a~     long-term catheter with easy handling in extra-hospital condition. All these advantages~     suggest that this technology offers lower cost to the health system and more benefits for~     patients. However, PICC is not available for use in infusion therapy in patients of the~     Brazilian public health system, except for neonates.~      The available literature does not address cost-effectiveness studies of this technology in~     the international scope comparing the PICC versus CVC. And, similarly, we do not have studies~     conducted in Brazil to incorporate this technology into our public health system, based on~     its benefits and potential cost reduction.~      In order to fill this gap, this study aims to test if the use of PICC in patients with~     infusional therapy equal or superior to 10 days (Intervention Group), will show a lower~     incidence in the outcomes (infection, thrombosis or mechanical complications), besides being~     more cost-effective when compared to the use of CVC of short stay (Control Group).~   "
13296|NCT03392818|"~     To measure the distance between the upper edge of the thyroid cartilage to the upper edge of~     the sternum add the distance from the upper edge of the sternum to the carina was calculated~     according to the chest CT scans as a guide to the placement of Uniblocker without the aid of~     FOB.~   "
13297|NCT03392805|"~     exercise and physical activity can have an anti-inflammatory effect, while there is evidence~     that a sedentary lifestyle could be the basis for the development of systemic inflammation~     and increased cardiovascular risk. The primary objective is to assess whether regular~     physical activity is able to induce a decrease in systemic immune-activation in HIV positive~     patients.~   "
13298|NCT03392792|"~     • Aim of the work To register all type of acute stroke admitted in Assiut university Hospital~     and assessment of their risk factor, morbidity and Mortality~   "
13299|NCT03392779|"~     This study will evaluate the safety, tolerability and pharmacokinetics (PK) of escalating~     single- and multiple-oral doses of ZSP1601 on fasted condition, and characterize PK of~     ZSP1601 on an empty stomach (fasted condition) and following a high fat, high calorie meal~     (fed condition) in a 2-period, 2-sequence manner. The study will be conducted in 3 parts~     (Ascending single dose, multiple dose and food effect). Participants will receive either~     ZSP1601 or placebo .~   "
13300|NCT03392766|"~     Many intrathoracic procedures demand optimal collapse of the operative lung to facilitate~     surgical exposure. Single-lung ventilation can be achieved using a double-lumen tube (DLT), a~     Univent tube, or an independent bronchial blocker. Insertion of a DLT using a direct~     laryngoscope can be more difficult than that of single-lumen tube (SLT), especially in~     patients for whom airway difficulty is anticipated. The safest of the proposed methods~     involves the placement of an SLT with the aid of an fibreoptic bronchoscope (FOB), following~     which the SLT is replaced with a DLT using an airway exchange technique in these patients.~     HumanBroncho® (Insung Medical, Seoul, Korea) is a new silicone DLT with a soft, flexible,~     non-bevelled, wire-reinforced tip. The oval shape, obtuse angle, and short lateral internal~     diameter of the bronchial lumen and its flexibility may allow for advancement to the trachea~     over the FOB with as much as ease as a standard SLT. In the present study, the investigators~     aimed to test the hypothesis that the HumanBroncho® DLT would be non-inferior to a standard~     SLT with regard to intubation time over an FOB in patients with semi-rigid neck collar~     simulating difficult airway.~   "
13301|NCT03392753|"~     This study will be comparing the treatment of varicose veins using either mechanochemical~     ablation (MOCA) or cyanoacrylate adhesive (CAE). Patients will be randomised to receiving~     either MOCA or CAE.~      The pain scores, clinical scores, quality of life scores, occlusion and re-intervention rate~     at 2 weeks, 3, 6 and 12 months as well as the cost effectiveness of each intervention will be~     assessed.~   "
13302|NCT03392740|"~     The intent of the study is to show the potential benefits of angiotensin converting enzyme~     inhibitors in preventing anthracycline induced cardiotoxicity.~      This is a prospective, randomized, blinded and placebo-controlled clinical trial that will~     enroll patients who are to be treated with anthracycline chemotherapy (doxorubicin,~     epirubicin, idrarubicin, or mitoxantone) to either lisinopril or placebo group. The study~     will be performed at the Genesys Hurley Cancer Institute. The treating oncologist who intends~     to start the patient on anthracycline chemotherapeutic agent will provide the patient with a~     recruitment flyer and informed consent form and then referred to the research nurse. Subjects~     interested in participation, that do not meet any of the exclusion criteria, will be~     consented and enrolled by the research nurse prior to their first treatment with~     chemotherapy. Over a period of 1 to 3 weeks the study medication will be titrated in a~     stepwise fashion to a target of 20 mg daily, maintaining a systolic blood pressure greater~     than 90 mmHg. A baseline echocardiogram with strain and strain rate imaging will be obtained~     prior to initiation of anthracycline chemotherapy. Subsequent echocardiograms with strain and~     strain rate imaging will be performed every 3 months for a total of 12 months.~      Patients will be followed for a total of 12 months, starting on the day of enrollment. We~     intend to recruit a total of 200 patients.~      The primary endpoint of this study is a change in change in strain and strain rate parameters~     prior to, during, and after anthracycline chemotherapy compared to placebo.~      Study data will be collected and managed using the Ascension installation of REDCap (Research~     Electronic Data Capture). REDCap is a secure, web application designed to support data~     capture for research studies, providing user-friendly web-based case report forms, real-time~     data entry validation (e.g. for data types and range checks), audit trails and a~     de-identified data export mechanism to common statistical packages.~      Echocardiographic data will be stored in cine-loop format on a private, password protected~     echocardiogram viewing software and analyzed by a separate blinded cardiologist.~      Patients will be evaluated according to the standard oncologic evaluation. The treating~     oncologist will make decisions on their treatment based on their personal standards and~     clinical judgement.~   "
13303|NCT03392727|"~     This study will evaluate baby box ownership and safe sleep practices (sleep location, sleep~     position, use of bedding) among families provided a free baby box and standardized safe sleep~     education compared to families provided a safe sleep pamphlet and information on how to~     obtain a free box in the community.~   "
13304|NCT03392714|"~     This pilot study will i) evaluate the efficacy and the safety of bendamustine-based~     combination chemotherapy and ii) investigate the pharmacokinetics (PK)of bendamustine in~     plasma and CSF when given as salvage treatment for patients with relapsed or refractory~     primary central nervous system lymphoma (PCNSL).~   "
13305|NCT03392701|"~     It has been recognized lately that sepsis and inflammation has an important impact on lipid~     metabolism and that the extent of hypocholesterolemia may even be a marker of severity of~     illness. However, the interplay between inflammation and the marked changes in lipid~     metabolism remain to be sufficiently understood. Importantly, the exact kinetics of lipid~     parameters in inflammatory conditions are yet to be explored. This study aims to investigate~     the interaction between inflammation and lipid metabolism using the human endotoxin model~     (LPS infusion) in ten healthy volunteers in a single blinded randomized placebo controlled~     cross-over design.~   "
13306|NCT03392688|"~     Early activation of lateral hamstrings (LH) in respect of medial hamstrings (MH) may cause~     abnormal knee abduction and external rotation moments in individuals. This situation may~     increase the risk of ligament injury and may be the reason for susceptibility of~     patellofemoral pain (PFP). The aim of this study is to compare the time delays in~     electromyographic studies between medial and lateral hamstrings in patients with PFP and~     asymptomatic subjects.~   "
13307|NCT03392675|"~     This pilot project will provide an understanding of the contextual variables responsible for~     breast and nipple pain during breastfeeding initiation. These variables include, genetic~     variation, pain sensitivity, reactivity, pain catastrophizing and perceived stress. The~     purpose is to understand the efficacy of self-management (SM) strategies on each of these~     contextual variables, in an effort to inform a personalized approach to managing~     breastfeeding pain and its effect on improved health outcomes.~   "
13308|NCT03392662|"~     To assess the clinical performance and safety of HEMOPATCH Sealing Hemostat in a~     post-marketing setting in cardiovascular, thoracic, urologic, neurological, and other general~     surgical procedures.~   "
13309|NCT03392649|"~     Patients undergoing cardiac surgery, specifically a coronary artery bypass graft and/or heart~     valve replacement surgery, are at a higher risk for post-procedure atrial fibrillation (AF).~     AF is a condition in which the upper chambers of the heart do not contract normally and~     results in an irregular heartbeat. Recent studies have shown that tragus stimulation~     decreases the likelihood of AF in animals and humans. It has also been shown to reduce~     inflammation which may be related to post-procedure AF. Tragus stimulation involves~     stimulating a part of the outer ear, called the tragus, by sending a microcurrent through a~     small alligator clip. It is believed that tragus stimulation can affect the nervous system,~     which may reduce heart rate and lead to prevention of AF. The purpose of this study is to~     determine whether tragus stimulation in subjects undergoing cardiac surgery will lead to~     shorter occurrences, or even prevention, of AF.~   "
13310|NCT03392636|"~     the study is basically aimed at comparing two techniques of herniotomy by comparing there~     recurrence rates~   "
13311|NCT03392623|"~     BACKGROUND: Malar melasma has a chronic and recurrent character that may be related with~     epigenetic changes.~   "
13312|NCT03392610|"~     Reusable (RU) flexible bronchoscopes (FB) require intermediate level disinfection operations~     to prevent transmission of infectious agents from patient to patient. These operations have a~     significant material and human cost and impact their availability in case of emergency. One~     alternative is the use of disposable FB.~      The aim of the study is to evaluate the quality of FB during procedures carried out with each~     of the two solutions in intensive care unit (ICU), respiratory endoscopy (RE) and anesthesia~     (A) department.~      A prospective non-interventional and non-randomized monocentric study compare the operator~     satisfaction of therapeutic procedures performed with RU FB (EB FujifilmTM range, FB/FI~     PentaxMedicalTM range, StorzTM intubation FB) versus disposable FB (aScope 3® and aScope 4®~     (AmbuTM), Broncoflex® (AxessvisionTM). An evaluation form is completed by the operator at the~     end of procedure. Judging criteria, rated from 0 to 10, concern handling, ergonomics, image~     and suction quality.~   "
13313|NCT03392597|"~     This research will examine if participation in a strengths-based curriculum, the Brothers as~     Allies program adapted from the Council for Boys and Young Men, reduces risk for future~     sexual violence perpetration among middle school-aged boys in New York State.~   "
13314|NCT03392584|"~     The intention of the study is to explore metabolic and inflammatory parameters in the pelvis~     after abdominoperineal resection for locally advanced rectal cancer in patients that have~     received radiation therapy before surgery.~   "
18880|NCT03319810|"~     This is a proof of concept study to determine if changes in brain amyloid levels are evident~     three months after infusion of 0.4 g/kg of IVIG every 14 days x 5 infusions. Amyloid levels~     will be measured by Florbetapir PET and retinal scan.~   "
13315|NCT03392571|"~     This is a phase II multi-center study of nab-paclitaxel, gemcitabine and cisplatin (NGC~     triple regimen) as preoperative therapy in potentially resectable pancreatic cancer patients.~      DISEASE STATE~        -  Potentially operable or borderline resectable pancreatic adenocarcinoma as assessed by~          standard CT criteria and histologically confirmed.~        -  Staging by pancreatic protocol, helical abdominal computed tomography (with contrast) or~          MRI (with contrast) required (endoscopic ultrasound is not required).~        -  No evidence of metastatic disease. Lymphadenopathy (defined as nodes measuring >1 cm in~          short axis) outside the surgical basin (i.e., para-aortic, peri-caval, celiac axis, or~          distant nodes) is considered M1 (unless nodes are biopsied and are negative, then~          enrollment can be considered after review with the study PI).~      Potentially Resectable Pancreatic Cancer~        -  No involvement of the celiac artery, common hepatic artery, and superior mesenteric~          artery (SMA) and, if present, replaced right hepatic artery.~        -  No involvement or <180° interface between tumor and vessel wall of the portal vein~          and/or superior mesenteric vein (SMV-PV) and patent portal vein/splenic vein confluence.~        -  For tumors of the body and tail of the pancreas, involvement of the splenic artery and~          vein of any degree is considered resectable disease. Borderline Resectable Pancreatic~          Cancer~        -  Tumor-vessel interface ≥180° of vessel wall circumference, and/or reconstructible~          occlusion of the SMV-PV.~        -  Tumor-vessel interface <180° of the circumference of the SMA.~        -  Tumor-vessel interface <180° of the circumference of the celiac artery.~        -  Reconstructible short-segment interface of any degree between tumor and hepatic artery.~   "
13316|NCT03392558|"~     This study evaluates a nature-based sensitive skin regimen (NBSSR), as a suitable adjunct~     topical application to prescription medication when administered daily over the course of~     four weeks, in moderate to severe rosacea in comparison to the control regimen (CR).~   "
13317|NCT03392545|"~     The study will investigate combined radiotherapy and immunotherapy on recurrent~     glioblastoma(GBM). Immune adjuvants will be injected intratumorally and systemically to~     induce antitumor-specific immunity after radiation induced immunological tumor cell death~     (ICD). With radiation, tumor cells release tumor antigens that are captured by antigen~     presenting dendritic cells. Immune adjuvants promote the presentation of tumor antigens and~     the priming of antitumor T lymphocytes. The combined treatment induces and amplifies the~     specific antitumor immunity in recurrent GBM patients, prolonging survivals for GBM patients.~   "
13318|NCT03392532|"~     The purpose of this research study is to compare the performance of two different types of~     Alcon soft toric study contact lenses to obtain information on study lens orientation.~   "
13319|NCT03392519|"~     In chronic stroke patients, brain network reorganization and recovery mechanism are~     investigated after stroke onset using functional MRI and diffusion tensor imaging analyses.~   "
13320|NCT03392506|"~     The purpose of this study is to make a qualitative and quantitative analysis of the~     intrathoracic lymph nodes by CP-EBUS elastography for the first time, and to make a benign~     and malignant diagnosis.~   "
13321|NCT03392493|"~     Robotic therapy can deliver larger amounts of upper extremity movement practice for stroke~     rehabilitation. Although the treatment effects were supported in studies, there are still~     limitations in clinical intervention. The study will use the robot-assisted hand~     rehabilitation with a Gloreha device. Thirty patients with moderate motor deficits were~     recruited and randomized into 2 treatment groups, AB or BA (A = 12 times of robot-assisted~     hand rehabilitation, B = 12 times of standard therapy) for 12 weeks of treatment (Sixty~     minutes a time, twice a week), 1 month of break between conditions for washout period. The~     performance was assessed by a blinded assessor for five times (pre-test1, post-test 1,~     pre-test2, post-test 2, follow up at three month). The outcome measures Fugl-Meyer~     Assessment-Upper Limb section(FMA-UE),Box and block test(BBT), Maximal voluntary~     contraction(MVC) of extensor digitorum communis(EDC), Abductor pollicis brevis(APB), Flexor~     digitorum(FD), Dynanometer, Semmes-Weinstein hand monofilament (SWM), Revision of the~     Nottingham Sensory Assessment (EmNSA), Modified Barthel Index. Collected data will be~     analyzed with ANOVA test by SPSS version 20.0, and alpha level was set at 0.05. The~     hypothesis are robot-assisted hand rehabilitation with a Gloreha device has positive effects~     on sensory, motor, hand function, and ADL ability among patients with stroke.~   "
13322|NCT03392480|"~     Patients with major orthopedic surgery will be recruited. Participants will be monitored for~     delirium after surgery. Participants' blood will be harvested for the determination of~     haptoglobin types, levels of oxidative stress and inflammation. Investigators will then~     analyze the data to see if haptoglobin 2-2 type is associated with an increased postoperative~     delirium, inflammation and oxidative stress.~   "
13323|NCT03392467|"~     This study is to evaluate the efficacy and safety of PNEUMOSTEM® for the Prevention and~     Treatment of Severe Bronchopulmonary Dysplasia (Severe BPD) in Premature Infants. Half of~     subjects will receive PNEUMOSTEM, while the other half will receive a placebo.~   "
13324|NCT03392454|"~     The purpose of this study was to measure the differences in Health Related Quality of Life~     (HRQOL) and functional measurements between two groups of patients with Carpometacarpal~     Osteoarthritis of the thumb.~   "
13325|NCT03392441|"~     What are the effects of transient insulin deprivation on brain structure, blood flow,~     mitochondrial function, and cognitive function in T1DM patients?~      What are the effects of transient insulin deprivation on circulating exosomes and metabolites~     in T1DM patients?~   "
13326|NCT03392428|"~     This open label, randomised, stratified, 2-arm, multicentre, phase 2 trial aims to determine~     the activity and safety of Lu-PSMA vs cabazitaxel in men with progressive metastatic~     castration resistant prostate cancer~   "
13327|NCT03392415|"~     Randomized registry for the study of CTO PCI as adjunction to optimal medical therapy.~   "
13328|NCT03392402|"~     This study evaluates the usefulness of molecular classifier to aid the diagnosis of~     malignancy in the material obtained by fine-needle aspiration biopsy (FNAB) of thyroid~     nodule. All participants will undergo FNAB with routine cytological assessment and molecular~     testing. Patients will undergo surgery or be followed-up, according to the clinical~     guidelines. The diagnostic power of combined molecular/clinical classifier will be compared~     to prediction based on clinical features only, by investigators blinded to the final~     diagnosis of surgical assessment.~   "
13336|NCT03392298|"~     This study aims to explore the pathways and targets of regulating globin expression, which~     might be related to Colla corii asini (CCA, E'jiao) treating anemia in pregnant women with~     β-thalassemia. Firstly, ten pregnant patients who meet inclusion criteria will be randomly~     assigned to either the treatment group or control group in a 1: 1 ratio. The patients in the~     treatment group will be given 15 g of CCA daily for 4 weeks and followed up, while the~     control group will be treated with nothing and followed up in the same period. The~     transcriptional test and bioinformatics analysis would be conducted to detect and determine~     the potential pathways and targets of regulating globin expression before and after the~     treatment. Secondly, sixty pregnant patients who meet inclusion criteria will be randomly~     assigned to either the treatment group or control group in a 2: 1 ratio. The treatment group~     and control group respectively received the same treatment and follow-up regimen as the~     transcriptional study mentioned above. According to the results of the transcriptional study,~     the target gene signaling pathway molecules, Hb concentration, and the levels of α-、β-、γ- and~     δ-globin will be detected and compared.~   "
13337|NCT03392285|"~     Purpose The purpose of this study is to compare the clinical outcome and the rate of~     reoperations in a cohort of patients with undisplaced femoral neck fractures treated with~     internal fixation and patients with displaced femoral neck fractures treated with hip~     arthroplasty.~      Methods In a consecutive series of patients we compared the results of internal fixation for~     undisplaced femoral neck fractures with those of hip arthroplasty for displaced fractures~     (control group) of elderly patients. Risk of reoperation and patient reported hip function~     assessed with Harris hip score and WOMAC were used as outcome measurements.~   "
13338|NCT03392272|"~     Fibrin glue is widely used in ophthalmology for homeostasis and tissue recovery. It is~     commonly used in ocular surface surgeries such as pterygium removal and conjunctival lesions~     excisions. In Müller's muscle-conjunctival resection (MMCR), sutures are used to reconnect~     the conjunctiva and Muller muscle, which causes discomfort and pain for the patient. The~     investigators' goal is to explore using fibrin glue instead of sutures in MMCR surgeries to~     shorten the procedure's length and alleviate patients discomfort and pain. This is especially~     important in the management of children suffering ptosis, where sedation and even general~     anaesthesia is required for sutured removal as a secondary procedure.~   "
13339|NCT03392259|"~     We previously developed the smartphone app (Heart4U) which is coupled with electronic medical~     record system in Seoul National University Bundang Hospital. In this study, we aim to~     evaluate clinical usefulness of smartphone app regarding the control of conventional risk~     factors in patients with history of cardiovascular disease.~   "
13340|NCT03392246|"~     This research study is studying a combination of two targeted therapies as a possible~     treatment for Non-Small Cell Lung Cancer (NSCLC) with an EGFR mutation.~      The drugs involved in this study are:~        -  Osimertinib (Tagrisso)~        -  Selumetinib~   "
13341|NCT03392233|"~     Stereotactic Body Radiation Therapy(SBRT) for spinal metastases has been proved a good~     results in pain relieve and local control, However,the longterm of efficacy and safety of~     this regimen is unclear.The purpose of the study is to evaluate the longterm outcome of this~     therapeutic regimen in selective patients who will be survival more than 2 years.~   "
13342|NCT03392220|"~     Supraglottic laryngeal carcinoma patients with clinically negative neck (cN0) will be~     randomized divided into two groups. Patients in case group will undergo unilateral neck~     dissection (II-IV) while bilateral neck dissection (II-IV) in control group. Regional control~     rate is the primary endpoint and comparison will be made to see if unilateral dissection can~     get similar regional control as control group.~   "
13343|NCT03392207|"~     Rationale and Background: Since 2013, Butantan Institute has been performing passive~     pharmacovigilance activities related to its triavalent, fragmented and inactivated vaccine~     (IB TIV).~      Objetive: To conduct an active surveillance study focusing on the elderly and health care~     professionals as part of Butantan pharmacovigilance plan, while passive surveillance~     activities will continue. The pharmacovigilance plan, via active surveillance, is being~     implemented in response to WHO requirements for pre-qualification of IB TIV.~   "
13344|NCT03392194|"~     The purpose of this study is to evaluate the feasibility of conducting a future randomized~     control trial that will compare the efficacy of sleep behavioral interventions in a high-risk~     community including adapted sleep hygiene and yoga. The investigators will conduct a 40~     person 12-week randomized control trial (RCT) in low-income housing population where half the~     participants will receive a community adapted sleep hygiene intervention (SH) and half will~     receive a community adapted sleep hygiene intervention and a yoga intervention. The~     investigators will evaluate the feasibility of recruiting from our target community,~     randomizing individuals to interventions delivered in community rooms with home-based~     practices, and delivering the targeted interventions with high adherence and fidelity.~   "
13345|NCT03392181|"~     The purpose of this study is to gain understanding of how PET-MR (positron emission~     tomography-magnetic resonance imaging) using the substance 18F-DCFPyL (PyL) may help in~     diagnosing prostate cancer and in determining the stage of prostate cancer before surgery.~   "
13346|NCT03392168|"~     This study is designed to assess the safety and pharmacokinetics (PK) of a single dose~     application of ARQ-151 cream 0.5% to 25 cm2 of psoriatic plaque(s) (Cohort 1). The study will~     also assess the safety, PK and efficacy of different doses and multiple applications of~     ARQ-151 cream 0.5% vs placebo and ARQ-151 cream 0.15% vs placebo applied once a day for 28~     days to individuals with 0.5% to 5.0% body surface area (BSA) of chronic plaque psoriasis~     (Cohort 2).~   "
13347|NCT03392155|"~     Researchers are trying to evaluate and recommend sustainable and effective health and~     wellness programs for people with spinal cord injury (SCI) and other physical disabilities.~   "
13348|NCT03392142|"~     This is a multicenter, open label, single-arm, phase 3 study to assess the efficacy and~     safety of tabelecleucel for the treatment of Epstein-Barr Virus-associated post-transplant~     lymphoproliferative disease (EBV+ PTLD) in the setting of allogeneic hematopoietic cell~     transplant (HCT) after failure of rituximab.~   "
13349|NCT03392129|"~     This study has the aim to assess the effectiveness of the Ai Chi method as an adjunct therapy~     in the treatment of children with asthma.~   "
13350|NCT03392116|"~     The purpose is to evaluate the safety, tolerability, and PK of NGM120 in healthy adult~     subjects~   "
13353|NCT03392077|"~     Cesarean delivery is one of the most commonly performed surgical operations worldwide~     Cesarean delivery even as an elective procedure has been associated with considerable~     maternal risks compared with vaginal delivery. Some of the complications include postpartum~     hemorrhage, uterine infection, urinary tract infection, wound infection, septicemia and~     maternal death. Over the years, many variations in the surgical technique of Cesarean~     delivery have been employed with the main purpose of improving its safety. A woman's cervix~     is firm and undilated at the beginning of pregnancy, but progressive remodeling occurs during~     gestation until the cervix is soft at term, especially the nulliparous cervix . The~     progressive dilatation of the cervix needs uterine contraction during labor. A mechanical~     dilatation of the cervix at cesarean section is defined as an artificial dilatation of the~     cervix performed by finger, sponge forceps or other instruments at non-labor cesarean~     section. According to a cochrane view The information currently available about the~     advantages of cervical dilatation at cesarean section is inconclusive. This may be due to~     small sample sizes and low power of statistic.~   "
13354|NCT03392064|"~     A study to evaluate the safety and tolerability of AMG 119 in adult subjects with~     Relapsed/Refractory Small Cell Lung Cancer (SCLC) and determine the appropriate cell dose.~   "
13355|NCT03392051|"~     This is a single center, open label, single sequence, two treatment, two-period drug-drug~     interaction study to evaluate the effect of multiple doses of ISIS 681257 on the~     pharmacokinetics of multiple doses of clopidogrel~   "
13356|NCT03392038|"~     To study and compare a thick vs thin acellular dermal matrix for root coverage using the~     coronally positioned tunnel technique.~   "
13357|NCT03392025|"~     Flaxseed consumption has beneficial effects on cardiovascular risk factors. In addition, the~     benefit of the Mediterranean-like diet in primary and secondary prevention of cardiovascular~     diseases has been shown.The purpose of this study is to investigate the effects of flaxseed~     consumption, alone and in combination with the Mediterranean-like diet, in adjunct to~     conventional medical treatment, in improving vascular endothelial function, plasma lipid~     profile and high sensitivity c-reactive protein of coronary artery disease (CAD) patients.~   "
13358|NCT03392012|"~     Pediatric sedation is an anesthesiological technique with a good safety profile, but various~     complications might ensure, especially from the respiratory point of view. No suggestion is~     available about a possible upper safety limit for the duration of sedation to limit~     respiratory issue. In order to address this topic, the investigators concentrated on the~     occurrence of hypoventilated lung areas, which is a well-known side effect of anesthesia and~     sedation. The investigators hypothesis that the length of sedation is correlated with the~     occurrence of lung atelectasis and hypoventilation. To assess lung hypoventilation the lung~     ultrasound will be used. Lung ultrasound will be performed immediately after the induction of~     sedation and immediately before sedation interruption, in children scheduled for magnetic~     resonance exams.~      The study is a prospective observational study~   "
13359|NCT03391999|"~     Measuring Quality of Life in an upper secondary school in Denmark~   "
13360|NCT03391986|"~     The proposed study will be a randomized, double blinded, placebo-controlled trial to evaluate~     the efficacy of auricular acupuncture as adjunct for pain management during abortion. Women~     seeking first trimester uterine aspiration procedure who enroll in the study will be~     randomized to receive: 1) auricular acupuncture using pyonex needles, 2) placebo using an~     adhesive, 3) or routine care. Both participants and the treating physician will be unaware of~     treatment assignment. The primary outcome will compare the maximum pain score as measured by~     the visual analog scale (VAS) between the auricular acupuncture group and the routine care~     group. The secondary outcome will compare the maximum pain score between placebo group to the~     routine care group. The study will also investigate patient satisfaction.~   "
13361|NCT03391973|"~     Abbreviated Title: Pembrolizumab in Patients with Poor-Prognosis Carcinoma of Unknown Primary~     Site (CUP) Trial Phase: 2 Clinical Indication: Treatment naïve patients with poor prognosis~     carcinoma of unknown primary site Trial Type: Single arm phase 2 Type of control: Not~     applicable Route of administration: Intravenous Trial Blinding: Not applicable Treatment~     Groups: 1) Pembrolizumab 200 mg IV every 3 weeks for up to 24 months. Total Number of trial~     subjects:25 Estimated enrollment period: 24 months Estimated duration of trial: 48 months~     Duration of Participation: 24 months~   "
13362|NCT03391960|"~     Insertion and maintenance of central venous catheter (CVC) lines are common hospital~     procedures in patients, including those being treated for cancer. CVCs allow clinicians an~     access point for infusion of fluids, blood sampling, and measurements, decreasing the need~     for repeated needle sticks to the patient. However, bloodstream infections associated with~     CVCs (CLABSIs) are a serious complication, leading to significantly longer hospital stays,~     morbidity, and mortality. Keeping catheter ports disinfected reduces the risk of bloodstream~     infection; however, consistent and adequate maintenance and disinfection of the line can be~     difficult.~      The purpose of this study is to demonstrate that passive disinfecting caps can provide a~     patient safety practice that is easy for clinicians to follow, as well as providing easily~     auditable compliance, which may lead to lower CLABSI rates.~      The compliance rate for needleless connector disinfection will be evaluated after~     implementation of the passive disinfecting cap, and compared to the pre-intervention rate.~     The CLABSI rates before and after cap implementation will also be compared.~   "
13363|NCT03391947|"~     A clinical evaluation of using the semilunar coronally position flap (SCPF) compared to the~     conventional coronally advanced flap (CAF) with modification to treat class I Miller gingival~     recession. The coronally repositioned gingival margin will be stabilized by coronally~     anchored suture with composite stops on the buccal surface of the tooth using flowable~     composite. The sample size will be ten patients. Each patient has bilateral Miller Class I~     gingival recessions; one will be treated with SCPF, while the other will be treated with CAF~   "
13388|NCT03391622|"~     Cardiovascular diseases are the most common cause of death in the western world. Myocardial~     infarction pathogenesis usually involves the development of an atherosclerotic plaque and~     thrombus.~      Past research has shown a correlation between thrombin generation values and ischemic heart~     disease, however, to our knowledge no investigation has been done into the correlation of~     thrombin generation and cardiac catheterization results in ischemic heart disease patients.~      In the current research the investigator will investigate the correlation of thrombin~     generation values using calibrated automated thrombogram and cardiac catheterization results~     in active ischemic heart disease patients.~   "
13364|NCT03391934|"~     The study is designed as phase III, randomized, two armed, parallel, double blind (patient~     and assessor blinded), active controlled, and equivalency clinical trial with primary~     endpoint of Progression-Free Survival of Cetuximab® (produced by CinnaGen) compared with~     Erbitux® (Cetuximab, the reference drug) in patients with RAS wild-type Metastatic Colorectal~     Cancer with the allocation ratio of 2:1.Patients who met the following criteria could be~     recruited to receive the mentioned intervention randomly. Inclusion criteria: Male or female~     older than 18 years old, histologically confirmed adenocarcinoma of the colon or rectum which~     is metastatic, having one or more bi-dimensionally measurable lesions as defined by RECIST~     criteria, tumor that could not be resected for curative purposes,ECOG performance status~     score of 2 or less,life expectancy of longer than 3 months (clinical assessment),evidence of~     tumor EGFR expression (expanded wild-type RAS),adequate organ and marrow function as defined:~      ANC ≥ 1,500/mm3 Plt ≥ 100,000/mm3 Hb ≥ 9 g/dL (may have had blood transfusions) AST/ALT ≤ 2.5~     IULN or ≤ 5 IULN with known liver metastases Total bilirubin ≤ 1.5 IULN Serum Creatinine ≤~     1.5 IULN INR ≤ 1.5 and PTT ≤ 1.5 IULN~   "
13365|NCT03391921|"~     Phase IV prospective study measuring the immunogenicity (neutralizing antibody titles against~     each HPV vaccine genotype) of the 9-valent vaccine against HPV (Gardasil9®Merck, three doses~     at 0, 2 and 6 months) in HIV-positive women aged 15-40 years with fully suppressed HIV~     viremia on combined antiretroviral therapy. The safety of the vaccination (local or systemic~     reaction and impact on HIV viral control and immunodeficiency level) will be assessed. The~     cellular immune response will be assessed in a subgroup of patients.~   "
13366|NCT03391908|"~     The aim of Multiplaque clinical study is to assess the vulnerability degree of the~     atheromatous plaques, before and after a myocardial infarction (MI), based on multiomics~     analysis, associated with invasive and non-invasive data. In this study, a multi-parametric~     model for risk prediction will be developed, for evaluation of the risk that is associated~     with the vulnerable coronary plaques in patients that have suffered an acute coronary~     syndrome.~      In the study, evaluation of the imaging characteristics of these coronary plaques will be~     performed with the use of CT, OCT, IVUS and invasive angiography. We will study the~     correlation between plaque evolution and (1) the degree of vulnerability at baseline, (2)~     multiomics profile of the patients and (3) clinical evolution during follow-up.~      Also, new techniques for evaluation of the functional significance of coronary stenoses will~     be studied and validated, such as calculation of the fractional flow reserve or determination~     of shear stress in areas that are localized within the near vicinity of the vulnerable~     coronary plaques.~   "
13367|NCT03391895|"~     Scoliosis is the abnormality of the spine with direct effects on the shape and mechanics of~     the thoracic cage. Adolescent Idiopathic Scoliosis (AIS) is the most common 3-dimensional~     deformity of the spine which can potentially affect respiratory function, exercise capacity~     as well as the performance of inspiratory and expiratory muscles. During growth morphological~     changes of thoracic cage affects the pulmonary tissues and functions. Respiratory functions~     shows negative changes due to Cobb angle, curve localization, number of vertebra and onset~     age in patient with scoliosis.~      Exercise approaches include respiratory training program and aim to improve respiratory~     functions.It is reported that respiratory muscle weakness is a potent contributor to~     pulmonary impairment in mild, moderate, and severe forms of scoliosis. Studies showed that~     exercise training and respiratory exercises may improve respiratory function and exercise~     capacity in patients with AIS. Thus the aim of this study was to investigate the effect of~     inspiratory muscle training on respiratory muscle strength, respiratory function and~     functional capacity in adolescents with idiopathic scoliosis.~   "
13368|NCT03391882|"~     A study of an investigational drug to see how it affects the people with Parkinson's Disease~     complicated by motor fluctuations (OFF Episodes) compared to an approved drug used to treat~     people with Parkinson's Disease complicated by motor fluctuations (OFF Episodes)~   "
13369|NCT03391869|"~     The goal of this clinical research study is to learn if local consolidation treatment (LCT--~     surgery and/or radiation) plus immunotherapy (ipilimumab and nivolumab) is more effective~     than ipilimumab and nivolumab alone in treating patients with metastatic (has spread)~     non-small cell lung cancer (NSCLC) who have not previously received immunotherapy.~      This is an investigational study. LCT is FDA approved and commercially available for the~     treatment of NSCLC. Nivolumab and ipilimumab are FDA approved and commercially available for~     treatment of many types of cancer. It is considered investigational to use nivolumab and~     ipilimumab to treat metastatic NSCLC.~      The study doctor can explain how the study drugs and LCT are designed to work.~      Up to 270 participants will be enrolled in this study. All will take part at MD Anderson.~   "
13370|NCT03391856|"~     Isolated prolonged thrombocytopenia (PT) is a common complication after allogeneic stem cell~     transplantation with significant poor prognosis. No standard treatment is available. The~     current study assigned PT randomly to 2 arms: intervention arm with N-acetyl-L-cysteine (NAC)~     and control arm with supportive therapy.This is a prospective randomized controlled study.~   "
13371|NCT03391843|"~     A number of pilot studies had shown high rate of complete resection after neoadjuvant~     chemotherapy alone for local advanced rectal cancer(LARC), but they did not increase the~     ratio of pathological complete response (pCR) which was associated with improvement of~     overall survival (OS). On the other hand,some clinical trials show that triple active~     cytotoxic agents (Fluorouracil, Oxaliplatin, Irinotecan, FOLFOXIRI) combined with cetuximab~     for EGFR wild type metastatic colorectal cancer had more effective than double~     agents.Therefore,a hypothesis is the FOLFOXIRI+Cetuximab as the neoadjuvant chemotherapy~     regimen might improve the patient's ratio of pCR.~   "
13372|NCT03391830|"~     To evaluate the benefit for statin use in prevention of of CI-AKI after computed tomography~     urogram (CTU).~   "
13373|NCT03391817|"~     40 patients meeting the criteria for obesity surgery are enrolled. Fecal microbiota~     transplantation (FMT) will be administered in gastroscopy 6 months before obesity surgery. 20~     of the patients will receive a fecal transplant of a thin donor and 20 will receive placebo -~     a transplant made of their on feces. Changes in weight, laboratory values, general well being~     and stool microbiota will be measured up to one year after the surgery; one and a half years~     after FMT. The hypothesis is that FMT and the change in gut microbiota will help to reduce~     and maintain lower weight.~   "
13374|NCT03391804|"~     Evaluate the efficacy and safety of ALLN-177 in adult and pediatric patients with enteric or~     primary hyperoxaluria and hyperoxalemia~   "
13375|NCT03391791|"~     Subjects who previously took part in an Adaptimmune study and received genetically changed T~     cells (including but not limited to MAGE-A10ᶜ⁷⁹⁶T and MAGE-A4ᶜ¹º³²T) are asked to take part~     in this long term follow-up study. Subjects will be asked to join this study once they~     complete the parent interventional study.~      The purpose of this study is to find out if the genetically changed T cells that subjects~     received in the parent study have any long-term side effects. No additional study drug will~     be given, but subjects can receive other therapies for their cancer while they are being~     followed for long term safety in this study.~      For a period of 15 years starting from last administration of the genetically changed T~     cells, subjects will visit their study doctor for a check-up and to have blood tests to look~     for any changes that might have happened because of the genetically changed T cells.~   "
13376|NCT03391778|"~     Patients who were previously treated with Adaptimmune NY-ESO-1ᶜ²⁵⁹T cells are asked to take~     part in this study to see how safe NY-ESO-1ᶜ²⁵⁹T cells are and what side effects they might~     cause over 15 years. Patients will not be treated with NY-ESO-1ᶜ²⁵⁹T cells as part of this~     study.~      For a period of 15 years starting from last treatment with NY-ESO-1ᶜ²⁵⁹T cells, patients will~     visit their study doctor to have their blood checked for any changes that might have happened~     because of the NY-ESO-1ᶜ²⁵⁹T cells. Patients can receive other therapies for their cancer~     while they are being followed for long term safety in this study.~   "
13377|NCT03391765|"~     The purpose of this study is to assess the long-term safety and efficacy of ABBV-8E12 in~     subjects with progressive supranuclear palsy (PSP).~   "
13378|NCT03391752|"~     More-2-Eat Phase 2 provides the opportunity to extend the implementation of the Integrated~     Nutrition Pathway to a total of 10 hospitals and more than 20 medical/surgical units.~     Building on the success of More-2-Eat Phase 1, key components of this implementation study~     will be a registry for self-managed data entry and reports and a community of practice to~     support implementation of nutrition screening at admission to hospital, subjective global~     assessment to diagnose and triage patients to care pathways and medication pass of a small~     amount of nutrient dense oral nutritional supplement. Success with implementation and impact~     on key patient outcomes will be determined.~   "
13379|NCT03391739|"~     There are limited treatment options for relapse/refractory B-cell acute lymphoblastic~     leukemia(ALL). However,CART-19 cells has emerged as a powerful targeted immunotherapy for~     highly refractory CD19+ acute lymphoblastic leukemia (ALL). This study aims to assess the~     safety and toxicity of CART-19 cells to patients with relapse/refractory B-cell ALL.~   "
13380|NCT03391726|"~     Relapsed/Refractory B Cell Lymphoma is a challenge to be treated, however,CART-19 cells could~     be very promosing. This study aims to assess the safety and toxicity of CART-19 cells for~     patients with relapse or refractory B cell lymphoma.~   "
13381|NCT03391713|"~     The purpose of this study is to determine the effectiveness of posters in improving patient~     awareness and knowledge of the signs and symptoms of stroke. The control group study will be~     conducted in the first two weeks. Subsequently, the intervention arm will occur in the~     subsequent two weeks.~   "
13382|NCT03391700|"~     Investigators assess and compare postoperative sore throat and hoarseness in the group~     maintaining moderate relaxation and deep relaxation during operation.~   "
13383|NCT03391687|"~     This study is designed to investigate the incidence of pancreatic fistula after radical~     gastrectomy in gastric cancer patients.~   "
13384|NCT03391674|"~     Antibiotic resistance has emerged world wide and is of major concern. Multidrug resistant~     (MDR) bacteria is widely spread and is now a major factor in morbidity and mortality in~     health-care settings. Among MDRs, carbapenem resistant Enterobacteriaceae (CRE) are of~     special concern, receiving the highest classification of urgent threat level in the US~     President Report. Consistent mortality rates of 40-50% are observed among inpatients with~     infections caused by CRE in hospitals worldwide, related mainly to unavailable, delayed or~     ineffective antibiotic treatment options. The extremely high mortality rates of patients with~     CRE infections have driven efforts to prevent the acquisition and spread of these bacteria in~     hospitals. These include screening for carriage, contact isolation of carriers, cohorting,~     dedicated healthcare staff and other infection control measures. These strategies have been~     proven as effective but are cumbersome and expensive. In most locations these strategies~     failed to completely eradicate CRE endemicity. CRE decolonization (eradication of~     colonization) might offer a double benefit - reducing the risk for the individual carrier to~     develop an infection due to the resistant strain (by that, potentially lowering the mortality~     risk) and preventing the bacteria from spreading to other patients, exposing them to the same~     hazard. Fecal microbiota transplantation (FMT), in which fecal material enriched with~     commensal microorganisms is transferred from a healthy donor, have proven efficacy in the~     treatment of recurrent Clostridium difficile infection (CDI) in multiple trails. Major~     adverse events that has been reported so far are mostly related to the route of~     administration (aspiration during nasogastric tube administration/colonoscopy). Other adverse~     events include mostly GI related symptoms (diarrhea, nausea, belching) and are self limited~     and resolve in few hours. FMT seems to be safe and effective both in immunocompetent and~     immunocompromised patients. The high efficacy of FMT in the treatment of a multi-drug~     resistant pathogen such as Clostridium difficile, suggest that it might be an efficient tool~     for other MDR pathogens (e.g. CRE). This study aim to assess the effects of FMT on~     colonization and clinical infections with CRE. The potential of FMT to restore the gut~     microbiome and compete with residual resistant strains offer a novel way to fight the current~     MDR epidemic. FMT will be applied in a randomized open label fashion to CRE carriers in a~     single center in Israel and will be given by capsules for 2 consecutive days followed by~     rectal sampling at predefined timepoint in the following 6 months.~   "
13385|NCT03391661|"~     This study is designed to determine if a brief educational program can alter the attitudes~     and knowledge of individuals with chronic back pain, which is likely to be non-structural in~     nature.~      Individuals will be randomly assigned to an experimental condition (performs written~     educational and emotional awareness exercises) or a control condition (completes a general~     health activities questionnaire). Comparisons will be made to assess the degree of~     centralized pain features and functional improvements at 1-month follow-up~   "
13386|NCT03391648|"~     Recruit the parturients who underwent cesarean delivery at Far Eastern MemorialHospital~     during 2012-2016. After reviewing medical record related to the pregnancy, demographic data,~     prenatal exam, laboratory data, indication for cesarean section, perioperative events, etc.~     will be recorded. Analysis will be focused on incidence, temporal trend, and risk factors of~     anesthesia-related adverse events and obstetric complications.~   "
13387|NCT03391635|"~     The objective of this trial is to compare the efficacy of electroacupuncture versus~     transcutaneous electric nerve stimulation for functional constipation~   "
13389|NCT03391609|"~     The purpose of this study is to investigate the effects of dexmedetomidine infusion on the~     stress response to intubation, postoperative analgesia, and renal functions (urinary output~     [UOP], creatinine and glomerular filtration rate [GFR]) in preeclamptic patient.~   "
13393|NCT03391557|"~     Background and Objectives: Elastography can reflect the difference of tissue hardness, which~     helps to identify the difference of hardness between benign and malignant tissues. The aim of~     this study was to evaluate the value of endobronchial ultrasound elastography in the~     differential diagnosis of benign and malignant intrathoracic lymph nodes. Materials and~     Methods: A total of 42 patients with intrathoracic lymphadenopathy required for EBUS-TBNA~     examination were prospectively enrolled. Firstly, All patients were evaluated by enhanced~     chest CT examination,the EBUS B-mode ultrasound and EBUS‑guided elastography before~     EBUS-TBNA.Then, the investigators evaluated every lymph node by describing the~     characteristics of the CT image (Short diameter, texture, shape, boundary ,mean CT value),~     B-mode ultrasound (short diameter, echo characteristic, shape, boundary) and elastography~     (image type, grading score, strain rate, blue area ratio). Finally, the pathological results~     were used as the gold standard. the investigators compare the characteristics of the 3~     evaluating methods alone and in combination between benign and malignant lymph nodes.~   "
13394|NCT03391544|"~     The recently introduced toric V4c toric ICL (STAAR Surgical Company, Monrovia, CA, USA) has~     been designed with a 360-µm central hole to allow aqueous humor to flow without the need for~     an iridotomy. As far as the investigators certain, there have been not well-established~     prospective studies on the role of the V4c toric ICL for myopic astigmatism correction.~     Therefore, the present study aimed to investigate the clinical outcomes and rotational~     stability and to analyze factors that influence the rotational stability in V4c toric ICL~     implanted eyes prospectively.~   "
13395|NCT03391531|"~     TAP block is a locoregional analgesic technique that consists of infiltrating a local~     anesthetic solution between the muscle layers of the abdominal wall. This block produces~     prolonged parietal analgesia.~      The aim of the study is to evaluate whether infiltration of the abdominal wall using TAP~     block reduces postoperative pain and postoperative analgesic consumption, and improves~     patient comfort after laparoscopic cholecystectomy. This effect will be clinically relevant~     only if parietal pain predominates postoperatively.~   "
13396|NCT03391518|"~     The study includes Caucasian patients with diagnosis of normal tension glaucoma and age- and~     sex-matched healthy individuals. Measurements of optic nerve head blood flow will be~     performed with laser speckle flowgraphy (LSFG). Also, the intraocular pressure (IOP),~     systolic and diastolic blood pressure, heart rate (HR), mean arterial pressure (MAP) as well~     as ocular perfusion pressure (OPP) will be evaluated. After baseline measurements individuals~     will be asked to ingest 800 ml of water in less than five minutes. Measurements will be~     repeated after 15, 30 and 45 minutes.~   "
13397|NCT03391505|"~     The overall aim of the study is to investigate the effects of an acute bout of physical~     activity on cognitive performance and long-term memory in elementary school children.~     Elaborating, the study seeks to investigate the effect of the intensity of the physical~     activity on cognitive performance and long-term memory in preadolescent children.~   "
13398|NCT03391492|"~     Study the incidence and outcome of invasive pulmonary aspergillosis (IPA) in ICU patients~     with severe influenza and in influenza-negative control patients with severe~     community-acquired pneumonia~   "
13399|NCT03391479|"~     This is a phase 2 study whose purpose is see how useful investigational drug, avelumab, is in~     patients with locally advanced or metastatic penile cancer who are unfit for or progressed on~     platinum-based chemotherapy.~      The usefulness of avelumab in this study population will be determined by anti-tumor activity~     assessed by objective response rate.~      Avelumab is a monoclonal antibody that binds to a protein called programmed death-ligand 1~     (PD-L1) and blocks its communication with another protein called programmed death protein 1~     (PD-1). The communication of these proteins are thought to be important in the growth of~     tumors. Blocking these proteins from communicating may stop or shrink tumors.~   "
13400|NCT03391466|"~     The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the~     clinical outcome compared with standard of care second-line therapy in patients with~     relapsed/refractory DLBCL.~   "
13401|NCT03391440|"~     To assess the efficacy, safety and Population Pharmacokinetic (PPK) of morinidazole and~     sodium chloride injection with levofloxacin hydrochloride and sodium chloride injection~     sequential of levofloxacin hydrochloride tablets in women with pelvic inflammatory disease:~     An Open-Lable Multicenter Prospective Non-Randomized Trial~   "
13402|NCT03391427|"~     Lidocaine and ketamine both are being used for perioperative analgesia. Perioperative~     lidocaine infusion has been shown to reduce postoperative pain and opioid consumption.~     Perioperative low dose Ketamine has shown improved postoperative pain and reduced opioid~     usage. We therefore tested the hypothesis that the combination would provide better analgesia~     in the milieu of intrathecal morphine.~   "
13403|NCT03391414|"~     This study will compare the use of inhaled concentrated sodium chloride solution to an~     inhaled solution of sodium bicarbonate in an attempt to decrease the thickness and stickiness~     of the mucus in the lungs of a person with cystic fibrosis. Also, this study is also looking~     at whether or not it is possible to decrease the acidity of the airways by inhaling sodium~     bicarbonate through nebulizer treatments.~   "
13404|NCT03391401|"~     Morbid obesity leads to non-alcoholic fatty liver disease (NAFLD), and not all NAFLD cases~     benefit from weight loss e.g. after bariatric surgery. Our aim is to find out, which~     intrahepatic factors and / or biomarkers might be beneficial or can be identified as~     prognostic factors for remission of NAFLD after weight loss. As other factors such as the~     microbiome or muscle and fatty tissue also influence the development of obesity and liver~     diseases, it is planned to examine these parameters before and after bariatric surgery as~     well.~      Tissue biopsies will therefore be taken during the surgery, and blood as well as stool~     samples will be collected and compared for suitable biomarkers before and after the~     intervention.~   "
13424|NCT03391141|"~     This study aims to validate whether the pattern of airway collapse recorded during~     Drug-Induced Sleep Endoscopy (DISE) mirrors that of natural sleep, and to develop a model for~     airway collapse. Sensors will be placed in subjects' upper airways during DISE and then~     during in-lab sleep studies. The sleep study results will be compared with OR findings to~     create an aerodynamic model for natural sleep and to assess whether airway observations~     during DISE were valid representations of natural sleep.~   "
13425|NCT03391128|"~     This study evaluates whether circulating levels of aminoterminal propeptide of type III~     procollagen (PIIINP) can predict the cardiovascular events in hemodialysis patients.~   "
13405|NCT03391388|"~     This phase II trial studies the side effects of three-dimensional conformal external-beam~     photon radiotherapy (3D-CRT), proton, or brachytherapy accelerated partial breast irradiation~     (APBI) in treating patients with breast cancer that has or hasn't spread from where it began~     in the breast to surrounding normal tissue. Radiation therapy such as photon and proton~     partial breast external beam radiotherapy, uses high energy x-rays to kill tumor cells and~     shrink tumors. Giving radiation therapy in different ways may kill more tumor cells.~     Brachytherapy, also known as internal radiation therapy, uses radioactive material placed~     directly into or near a tumor to kill tumor cells. It is not yet known whether photon or~     proton partial breast external beam radiotherapy or partial breast brachytherapy works better~     in treating patients with breast cancer.~   "
13406|NCT03391375|"~     EV07 is an open label phase I clinical trial to evaluate the effect of late boost on~     HIV-uninfected vaccinees from EV06 trial.~      The outcome of the EV06 trial has shown that the vaccine regimen is safe and well tolerated.~     Preliminary antibody immunogenicity analysis has demonstrated that the DNA/gp120 protein~     vaccine regimen induced strong gp120, gp140 and V1V2 region-focused binding IgG and~     neutralizing antibody responses. There is also preliminary evidence that S. mansoni infection~     may modulate antibody responses induced by vaccination1.~      Based on these preliminary immunogenicity results of the EV06 study, a study with an~     additional boost with DNA-HIV-PT123 and AIDSVAX®B/E (Late Boost) is warranted in order to~     better investigate and understand the effects of the late boost on the response rate,~     magnitude and durability of vaccine induced immune responses.~      The primary objective of EV07 is to evaluate the ability of the late boost combination of~     DNA-HIV-PT123 and AIDSVAX® B/E to enhance the pre-existing vaccine induced antibody~     responses.~   "
13407|NCT03391362|"~     This research study is studying stereotactic radiation (focused/pinpoint radiation that~     targets each individual tumor but not the surrounding brain) instead of whole-brain radiation~     (radiation targeting the entire brain) as a possible treatment for patients with small cell~     lung cancer and 1-6 brain metastases.~      The intervention involved in this study is:~      -Stereotactic (focused, pinpoint) radiation~   "
13408|NCT03391349|"~     The quantification of the proteomes : L-plastin, lipocalin and adiponectin was analysed in~     the subgingival tissue samples of generalized severe chronic periodontitis patients with and~     without diabetes mellitus.The demographic and the periodontal parameters were assessed and~     the correlated with the quantification of the proteins. The mRNA expression was analyzed with~     RT-PCR and the quantification of protein was done using ELISA.~   "
13409|NCT03391336|"~     Carpal tunnel syndrome (CTS) is the most common nerve compression disorder in the upper~     extremity. It can be treated with surgical or nonsurgical methods. When nonsurgical treatment~     is indicated, local corticosteroid injection into the carpal tunnel can be used to reduce~     pain and tingling sensation.~      Currently, the most widely used ultrasound (US)-guided CTS-injection method are transverse~     and longitudinal approach. Although we can accurately place needle within the carpal tunnel~     using this approach and this approach is easy to learn, median nerve injury (MNI) is still an~     inevitable complication and difficult to be treat.~      MNI is the most serious complication associated with a local corticosteroid injection for CTS~     among them. A MNI will be presented with shooting pain at the injection time or transient~     exacerbation of CTS symptoms following the corticosteroid injection because of the pain which~     often masked by anesthetic during injection. Permanent damage of MN should be considered if~     the symptoms persist and exacerbate for more than 48 hours. A surgical intervention such as~     neurolysis, resection or graft repair or a gentle debridement of the crystal from the nerve~     may be performed in the patients with median nerve damage. Hence, early recognition of MNI~     before corticosteroid injection may avoid the permanent damage of MN.~      Accordingly, the aim of this study is to determine the relationship between the MNI with the~     possible influencing factors and findings in the US-guided corticosteroid injection for~     patients with CTS with and to compare the therapeutic efficacy in the patients with and~     without MNI.~   "
13410|NCT03391323|"~     The study is a prospective, randomized comparison of total knee arthroplasty with the Medacta~     GMK Sphere® knee compared to the Medacta GMK PS knee, with comparison to data from previous~     trials of similar study design.~   "
13411|NCT03391310|"~     The enrolled children would be randomized to one of the groups 'study group' or 'Honey~     dressing group' or 'Group I' (honey dressing containing Active Leptospermum Honey also known~     as Manuka honey would be used), changed every alternate day for a maximum period of upto 8~     weeks (in cases of stage IV ulcers) or till healthy granulation tissue appears, whichever is~     earlier and 'control group' or 'Standard treatment group ' or 'Group 2' (paraffin gauze is~     applied after application of povidone iodine). Randomization will be performed as per~     protocol. Primary outcome will be reduction in time to healing of any stage of pressure ulcer~     and secondary outcomes will be treatment failure and new onset infection of ulcer.~   "
13412|NCT03391297|"~     The present study aimed to investigate the efficacy of 60-minute sessions of prolonged~     exposure (PE) for patients with posttraumatic stress disorder (PTSD) in Taiwan. A systematic~     case study will be employed to compare the efficacy of 60-minute PE session versus standard~     90-minute session with eight Taiwanese PTSD patients. Participants will include the~     individuals aged 18 or older who meet a diagnosis of DSM-5 PTSD and to experience moderate to~     severe symptoms for at least 3 months. Those who have current substance dependence,~     psychosis, and acute suicidality (i.e., recent suicidal ideation with intent and plan) will~     be excluded. Participants will receive 10-15 weekly session of PE treatment with 60- or~     90-minute sessions. The investigators hypothesized that: (a) 60-minute PE is as effective as~     90-minute PE in reducing PTSD and depressive symptoms as well as in promoting posttraumatic~     growth (PTG); and (b) the treatment gains will be maintained at 3-month follow-up.~   "
13413|NCT03391284|"~     Hypothesis: Postoperative pain will be equivalent in patients receiving preemptive oral~     acetaminophen as compared to patients receiving preemptive intravenous acetaminophen~     following minimally invasive benign gynecologic surgery.~      Primary outcome:~      • Difference in postoperative pain comparing preemptive use of PO versus IV acetaminophen~      o Mean Visual analog Scale (VAS) scores will be compared between the intervention group (PO~     acetaminophen) and the control group (IV acetaminophen).~      Secondary outcomes:~        -  Difference in postoperative analgesic use between groups~           o Narcotics, NSAIDs~        -  Difference in postoperative N/V between groups~           o Patient rated measure - none, mild, moderate, severe~        -  Cost comparison between drugs~   "
13414|NCT03391271|"~     ne of the most common cancers in women worldwide is breast cancer. A common used therapy in~     early-stage and metastatic breast cancer involves chemotherapy. Taxanes,~     microtubule-targeting agents (MTAs), are one of the most used chemotherapeutic agents in~     breast cancer patients. Unfortunately, this treatment comes with many unfortunate side~     effects. Chemotherapy-induced peripheral neuropathy (CIPN) is one of these common side~     effects. This condition involves paresthesia, numbness and/or burning pain in distal limbs.~     Eventually, loss of temperature sensation, loss of tendon reflexes and pain sensation can~     occur. Yet, no therapies have been developed to treat CIPN. At the moment, only symptom~     management is possible. Not only will this condition affect the patients' daily activities,~     but a chemotherapy dose reduction could also be necessary, influencing the outcome and~     overall survival rate of the patient.~      A new and emerging treatment for CIPN is photobiomodulation therapy (PBMT) or low-level laser~     therapy. During PBMT, visible and/or (near)-infrared laser light is used at the affected area~     to improve tissue repair and thereby promote functional recovery of peripheral nerves.~     Studies have shown positive results for patients with diabetic neuropathy. However, no~     studies have been undertaken specifically for taxane-induced neuropathy (TIN).~      We hypothesize that PBMT is an effective treatment strategy to prevent sensory symptoms~     associated with TIN. This can lead to an improved quality of life for the patient and no need~     for a chemotherapy dose reduction.~   "
13415|NCT03391258|"~     12 patients with severe resorbed maxillae referred to Implantology Institute® will be~     submitted to full arch surgery, with simultaneous implant placement and regeneration in the~     aesthetic zone, with the GLAM technique.~      Informed consents and local ethical committee clearance will be obtained. Pre, post and 12~     months' follow-up CBCT scans will be performed and 2 independent, calibrated operators will~     analyze the CBCT scans and mean bone values calculated. The distance from the nasopalatine~     canal to the center of each implant will be determined (4 different locations per patient,~     corresponding to implants 14; 11; 21; 24) and it will be the reference to other CBCTs.~     Implant length will be measured, from the neck (site 1) to the top and then a middle point~     will be assessed (site 2). Post-Surgical Volume (mm) will be determined from the most palatal~     point of cortical bone until the most buccal regenerated bone in each CBCT. Regenerated bone~     gain (mm) at post-op and at 1-year CBCTs will be calculated by the difference between pre and~     post-op or pre-op and 1 year CBCT measures, respectively. Regenerated Bone stability (%),~     defined as the percentage of regenerated bone at 12 months, will be calculated as the~     comparison between CBCT immediately after surgery and the CBCT at 12 months. Results will be~     presented as mean, with 95% CI.~   "
13416|NCT03391245|"~     It is widely known that vitamin D has an important role in calcium metabolism and bone~     mineralization. Its deficiency is related to rickets and osteomalacia in children and adults~     respectively. Vitamin D had a role in innate and acquired immunity. It increases innate~     defense and modulates lymphocytes activation, leading to a change toward a T2 helper response~     ).~      The role of vitamin D deficiency on the risk of bacterial infection among patients in~     intensive care units has been reported. An observational studies in children reported an~     association between low 25-OH vitamin D level and infectious viral diseases .~      The deranged metabolism of vitamin D in liver cirrhosis was first reported in the late '70s~     and was attributed mainly to impaired 25(OH)-vitamin D hydroxylation of the precursor vitamin~     D caused by impaired liver function. Low level of vitamin D was found independently to be~     associated with increased risk of bacterial infections in patients with liver cirrhosis.~      The observed relationship between the lack of vitamin D and the increase risk of mortality in~     cirrhotic patients could be attributed to bacterial infections. Thus, the association of low~     vitamin D levels with liver insufficiency and infections supports the use of vitamin D as a~     prognostic marker in the population of cirrhosis.~      Studies on the role of vitamin D as a risk factor for infections in patients with liver~     cirrhosis are not well studied in our locality(Upper Egypt).~   "
13417|NCT03391232|"~     TREOS' Phase I clinical trial will investigate the safety, tolerability, and immunogenicity~     of a single dose of PolyPEPI1018 CRC Vaccine as an add-on treatment to the standard-of-care~     maintenance therapy in patients with metastatic colorectal cancer. This study will also~     explore the accuracy of prediction of pre-existing and newly induced CD8+ T cell responses in~     each patient using the PEPI Test and T lymphocyte infiltration detected in accessible biopsy~     sites.~   "
13418|NCT03391219|"~     This study is aimed to compare the effect of combined intravitreal Bevacizumab and Fasudil~     injection with Bevacizumab only injection in patients with persistant macular edema secondary~     to ratinal vein occlusion.~      Methods:~      In this study patients with retinal vein occlusion patient who had at least three or more~     intravitreal AntiVEGF injection with persistence of macular edema at funduscopic examination~     is recruited. The eligible patients in randomized in two groups Bevacizumab and~     Bavacizumab + Fasudil and in injected intravitreally for 3 times monthly. In~     Bevacizumab+Fasudil group patients receive two injections at each session Bavacizumab and~     Fasudil. In Bevacizumab group patients receive only Bevacizumab. The patients are followed~     for 6 months and central macular thickness and visual acuity is measured at baseline and~     monthly for 6 month. Baseline ancillary exams include Fluorescein Angiography and~     OCT-Angiography which is performed at the final exam as well. Patients needing any~     therapeutic intervention is addressed during the 6 month follow up period.~   "
13419|NCT03391206|"~     The purpose of this study was to investigate the clinical role of bioelectrical impedance~     analysis (BIA) and the relationship between the occurrence of breast cancer related~     lymphedema (BCRL) and dietary factors in breast cancer survivors who underwent surgical~     treatments.~   "
13420|NCT03391193|"~     The aim of the study is to to assess the immunogenicity and safety of a quadrivalent~     influenza vaccine in a multi-dose presentation compared to a quadrivalent influenza vaccine~     in single-dose presentation, in children aged 6 months to 17 years.~   "
13421|NCT03391180|"~     The aim of this study is to determine the effect of ICON on White spot lesions compared to~     CPP-ACPF plus.~   "
13422|NCT03391167|"~     This study will define the postoperative analgesic effect of ESP block via amount of~     patient-controlled analgesia (PCA) and postoperative analgesic consumption (such as routinely~     and rescue analgesics) and compare the control group in patients having laparoscopic~     Cholecystectomy .~   "
13423|NCT03391154|"~     the effect using low dose levo thyroxine in pregnant females with TSH level more than 2.5~     mU/L in the first trimester on pregnancy outcome~   "
13426|NCT03391115|"~     The purpose of this research is to develop patient-centered palliative care interventions to~     improve patient-provider communication and Quality of Life (QoL) of ethnic and racial~     minority patients living with life-limiting illnesses. Eliciting personal experiences is an~     effective way for patients to communicate their cultural values and beliefs. This study will~     assess how to integrate the patients' personal experience narratives into the electronic~     health record (EHR). The primary hypothesis is that the implementation of a patient-centered~     intervention to elicit personal experiences that are included in the EHR will improve~     patient-provider communication and patients' QoL.~   "
13427|NCT03391102|"~     Stroke is one of the most important cause of mortality and disability in Brazil. The city of~     Matão, located in São Paulo state, with a population around 80.000 inhabitants, has~     conditions to develop a community-based stroke study, which can answer important questions~     regarding epidemiological data over the time.~      Therefore, the purpose of this prospective community based study is to observe trends in~     stroke incidence, types and sub-types of stroke, risk factors, prognosis, 30 days and one~     year case-fatality during a follow-up of ten years.~      This study offers the opportunity to conduct an epidemiological study of high quality which~     can obtain data to formulate public politics to reduce the social and economic impact of~     stroke in Brazil.~   "
13428|NCT03391089|"~     Current spine procedures can suffer from a variety of complications resulting in a high~     incidence (up to 55%) of misplaced screws and implants. This can lead to devastating clinical~     consequences, including neurologic and vascular injury, and extensive physical, mental, and~     economic damage. Surgical navigation has a great potential to reduce these risks through~     accurate guidance; however present technologies rely on intraoperative imaging that uses~     ionizing radiation (e.g. computed tomography, or fluoroscopy), which limits surgical anatomy~     registration updates to less than 3-4 time points during surgery. They also require~     cumbersome and lengthy set-up and registration of fiducial markers and have limited abilities~     to account for motion that occurs during surgery and patient positioning. Therefore, the~     investigators propose a real-time intraoperative optical topographical imaging based surgical~     guidance system capable of accurately guiding the placement of implanted devices such as~     screws.~   "
13429|NCT03391076|"~     LRTI (Lower respiratory tract infection) is a severe disease in China. The fast and accurate~     diagnosis of pathogens, bacteria or viruses that cause the infection is critical for the~     therapy. In this study, investigators assume that the use of FilmArray Respiratory Panel will~     provide more rapid and comprehensive evidences to physicians to diagnose LRTI which is caused~     by viruses or atypical pathogens and then reduce the length of antibiotics use by 0.5-1.0~     days as well as other hospital resources (length of hospital/ICU stay, take-away oral~     antibiotics, etc.). Secondly, investigators assume that in LRTI patients with viral infection~     and a low serum PCT level, fewer length of antibiotics use can be expected. Thirdly, the use~     of FilmArray Respiratory Panel will provide clearer epidemiology data of virus and atypical~     pathogens in hospitalized LRTI patients.~   "
13430|NCT03391063|"~     the trial is done in order to reinforce polyamide to improve its modulus of elasticity to be~     able to use it as a denture base material in all clinical cases~   "
13431|NCT03391050|"~     The purpose of this study is to make a preliminary assessment of the efficacy of a combined~     APR-246 and dabrafenib therapy regimen in patients with BRAFV600 mutant unresectable and/or~     metastatic cutaneous melanoma resistant to the dabrafenib/trametinib combination. In~     addition, the study aims to assess the safety profile of the combined APR-246 and dabrafenib~     therapy regimen, to explore potential biomarkers, and to further describe the anti-tumour~     activity of the combination of APR-246 and dabrafenib. The trial will enroll up to 31~     evaluable patients.~   "
13432|NCT03391037|"~     Egypt has a very high prevalence of HCV and a high morbidity and mortality from chronic liver~     disease, cirrhosis, and hepatocellular carcinoma. Approximately 20% of Egyptian blood donors~     are anti-HCV positive. Egypt has higher rates of HCV than neighboring countries as well as~     other countries in the world with comparable socioeconomic conditions and hygienic standards~     for invasive medical, dental, or paramedical procedures.~      Donor safety is on the top of our priorities as a team and it is widely recognized~     intraopertively during hepatectomy, there are several potential risks during the~     Perioperative period .~   "
13433|NCT03391024|"~     For a significant number of patients suffering from back pain, even basic daily activities~     become impossible. It is at this time that spinal surgery becomes necessary in order to~     improve the patient's quality of life. To combat these symptoms, surgical implants (e.g.~     pedicle screws, rods, etc.) are used to aid in stabilizing and correcting the deformities of~     the spine, particularly after spinal decompression. Surgical navigation has a great potential~     to improve the accuracy of correctly implanting these devices; however, present technologies~     rely on intraoperative imaging that uses ionizing radiation (e.g. computed tomography,~     fluoroscopy, etc.), require cumbersome set-ups, the physical attachment of fiducial markers,~     and cannot account for patient motion. Therefore, the investigators propose a real-time~     intraoperative optical topographical imaging based surgical guidance system capable of~     accurately guiding the placement of implanted devices such as pedicle screws.~   "
13434|NCT03391011|"~     For a significant number of patients suffering from back pain, even basic daily activities~     become impossible. It is at this time that spinal surgery becomes necessary in order to~     improve the patient's quality of life. To combat these symptoms, surgical implants (e.g.~     pedicle screws, rods, etc.) are used to aid in stabilizing and correcting the deformities of~     the spine, particularly after spinal decompression. The clinical need for spinal surgery is~     compounded by current and continuing demographic trends. As the general population continues~     to age, the number of orthopaedic surgical interventions is expected to rise drastically.~     Therefore, a significant opportunity exists for the implementation of surgical guidance~     technologies, for orthopaedic procedures, to combat this overwhelming health care burden.~   "
13435|NCT03390998|"~     This multi-site international clinical research project is a collaboration between~     investigators from multiple institutions in the USA, Canada, and Europe. Approximately 7 to~     11 sites will participate and provide data for analysis. Clinical operations (for data~     collection and analysis) across sites will be managed by Stanford. The study purpose is to~     determine differences in clinical and imaging presentation, in-hospital management and~     prognosis in peripartum and non-peripartum SCAD patients.~   "
13436|NCT03390985|"~     Specific aims:~        1. To elucidate the biological mechanism that leads to pulmonary and nutritional~          improvement in CF patients following treatment with ivacaftor using advanced techniques~          to assess changes of the pulmonary and nutritional status~        2. To examine the relation between the individual response to ivacaftor and the presence of~          modifier genes associated with CF disease severity,~        3. To assess altered CFTR function using new available in vivo tests,~        4. To validate newly developed in vivo sweat tests with well established functional tests,~        5. To establish correlation between the CFTR response to Vx-770 measured in a new ex vivo~          method (organoids) and the actual clinical and/or functional response in individual~          patients,~        6. To examine response in other CF-specific features such as aqua wrinkling.~        7. To examine if sleep/activity level changes.~        8. To establish a biorepository to enable further investigations.~   "
13437|NCT03390972|"~     The purpose of the study is to evaluate the impact of dexmedetomidine on swallowing function~     in healthy volunteers using combined pressure and impedance recordings. Furthermore, two~     different concentrations of dexmedetomidine will be studied to find out whether any posible~     impact of dexmedetomidine on swallowing function is dose-dependent.~   "
13438|NCT03390959|"~     Introduction: Diabetes mellitus (DM) can be considered as one of the most important chronic~     diseases in the public health system, presenting a high cost for health services. Along with~     the increase in diagnosed cases of DM, there is a simultaneous increase in DM-related~     manifestations, such as peripheral diabetic neuropathy, diabetic foot ulcers and amputations.~     Decreased plantar sensitivity caused by microvascular complications, reduced sensation of~     vibration and loss of pressure sensitivity may be associated with recurrent falls due to~     reduced proprioceptive feedback. Although much is known about the beneficial results of~     physical exercise on glucose metabolism and insulin action, there are still few studies that~     evaluate the effects of different types of physical exercise, especially proprioceptive~     training, on plantar pressure, balance and posture of individuals.~      Objective: The present study aims to evaluate the efficacy of proprioceptive training on~     plantar pressure, postural balance and posture in adults with Type 2 Diabetes Mellitus.~      Methods: This study is a randomized, double blind, controlled clinical trial (evaluator and~     statistician) with individuals of both sexes, with type 2 diabetes mellitus diagnosed for at~     least 3 years, over 45 years of age, that can walk without assistance or supervision of~     others. Two groups will be formed, the Control Group (CG) and the Trained Group (TG), and the~     ideal n will be calculated in a pilot study.~   "
13439|NCT03390946|"~     The aim of the study is to test the feasibility of four-drug, interval-compressed regimen in~     osteosarcoma.~      Primary objective is to explore the toxicity and mortality related to treatment. Secondary~     objectives are to examine tumor necrosis rates after neoadjuvant chemotherapy, and to~     evaluate the usefulness of circulating cell-free DNA, survivin, or transforming growth~     factor-beta1 levels as well as programmed cell death ligand 1 expression in tumor specimen as~     a predictive or prognostic biomarker in osteosarcoma patients.~   "
13440|NCT03390933|"~     Depression is present in about 20-30% of hemodialysis patients and is associated with~     morbidity and mortality. However, depression is inadequately diagnosed and treated among~     dialysis patients. This is due in part to the overlap between depressive symptoms (e.g.~     appetite change, trouble sleeping, feeling tired) and symptoms related to persistent~     metabolic derangements in hemodialysis patients (e.g. nausea, nocturnal cramps, feeling~     washed out after treatment). The overlap between depressive symptoms and dialysis-related~     complications makes it difficult to diagnose and therefore to treat depression. In addition,~     prescription of antidepressant medication may increase an already high pill burden and result~     in poor adherence. Moreover, the evidence base to guide depression treatment among~     hemodialysis patients is limited. In the investigators' previous work, they developed methods~     to use latent variables and structural equation modeling to isolate depressive symptoms.~     Other investigators have demonstrated that directly observed treatment enhances the~     effectiveness of tuberculosis and HIV treatment.~      Investigators now propose a cross-sectional study (Phase 1) followed by a single-arm clinical~     trial (Phase 2) at 17 dialysis facilities. The cross-sectional study will involve assessments~     of depressive symptoms (using the PHQ-9 screening instrument) as well as dialysis-related~     complications, anxiety, and quality of life (Quality of Life Questionnaire) in about 1083~     patients. Investigators will then use structural equation modeling to develop and validate a~     hemodialysis-specific PHQ-9 (hdPHQ-9) that will isolate depressive symptoms. The trial will~     involve 96 patients with confirmed depression who will be assigned to directly observed~     weekly antidepressant treatment with fluoxetine. The primary outcome of the trial will be~     remission of depression at 12 weeks. The trial results will also be used to compare the~     responsiveness of the PHQ-9 and the hdPHQ-9. Investigators anticipate that the hdPHQ-9 will~     be a valid and responsive instrument that will isolate depressive symptoms in hemodialysis~     patients and ultimately improve the screening and diagnosis of depression. Investigators also~     expect that directly observed weekly fluoxetine treatment will be an effective way to manage~     depression among hemodialysis patients.~   "
13441|NCT03390920|"~     The aim of the study is to determine the efficacy of an Amniotic Fluid Tissue Product for~     pain relief and functional improvements for all types of musculoskeletal conditions. The~     study is prospective, with outcome measures being obtained at numerous time points after the~     regenerative procedure.~   "
13442|NCT03390907|"~     The purpose of this study to evaluate and examine, weather use of Hybrid Argon Plasma~     Coagulation (APC) as adjunct to endoscopic mucosal resection (EMR) will reduce the risk of~     residual or recurrent neoplasia at 6 months. Hybrid APC is an existing FDA approved device~     for assist of ablation of abnormal tissue anywhere in GI tract.~   "
13443|NCT03390894|"~     This is a multicenter, cohorts study to collect information from patients diagnosed with~     early-stage invasive breast cancer who have been previously included in a neoadjuvant or~     adjuvant clinical trial of the GEICAM group.~      Patients will be included in this study from the moment of completion of the follow-up of the~     studies of origin and will be followed for approximately 30 years~   "
13444|NCT03390881|"~     This study aims at assessing whether breath acetone concentration is a good bio-marker of~     instantaneous energy balance in healthy subjects.~   "
13445|NCT03390868|"~     The interaction between people with intellectual disabilities and professional carers is~     often influenced by communicative difficulties contributing challenging behaviours.~      Aim: The aim of this study is to evaluate a web-based training program aimed at improving~     carers' abilities to interact with people with learning disabilities who exhibit challenging~     behaviours and to explore carers' experiences of participating in such a program.~      Method: This study has a cross-sectional design. Sample: The study will be conducted in~     twenty special community-based accommodations, group-homes, in Sweden that each houses 4-8~     residents. The staff in the group-homes is working independently with the manager located at~     distance.The staff (N=221) in this study works with people with intellectual disabilities who~     has different functional levels, from moderate to profound intellectual disabilities. They~     have different educational backgrounds: from basic nursing education at the college level to~     university degree.~      Intervention: The intervention consists of a web-based training program, available for all~     staff working in special accommodations for people with intellectual disabilities. The~     web-based training program focuses on strengthening the carers' communication skills.~      Procedure: The social Services authorities and the managers from each home agreed to the~     project. The carers have given their informed consent to attend the study. The participants~     will by their own during working hour go through the web-based program. The time to complete~     the web-based training program is estimated at approximately ten hours.~      Data-analysis: Descriptive statistics will be used for demographic data. Proportions will be~     compared to the chi-square test. The mean values between the groups will be compared by~     t-test or Mann-Whitney's U-test, as appropriate. Changes in the mean between and in the~     groups will be compared with paired t-test. Double-sided significance test will be used~     throughout. Data will be presented at a group level.~   "
13446|NCT03390855|"~     Nowadays there is an increasing demand by consumers on healthy food products prepared in~     convenient forms, simple to use and not containing additives. In this sense, broccoli sprouts~     (Brassica oleraceae var. italica) represent an interesting choice as they are rich in~     glucosinolates, nitrogen-sulfur compounds, that are believed to counteract the negative~     effects of diverse pathologies.~      Human studies have been focused on the antitumoral properties of these vegetables, however~     there is less evidence on the anti-inflammatory properties of cruciferous vegetables in~     humans.~      As obesity is linked to an inflammatory component, the aim of the study is to evaluate the~     anti-inflammatory action of broccoli sprouts in overweight adult subjects.~   "
13447|NCT03390842|"~     This study is a 40-week, blinded, placebo-controlled extension of Study TRCA-301~     (NCT03317444). Eligible subjects who complete the 12-week treatment period in Study TRCA-301~     have the option to participate in this extension study evaluating the long-term safety and~     durability of effect of TRC101 in subjects with non-dialysis dependent chronic kidney disease~     and metabolic acidosis. Eligible subjects will be treated with TRC101 or placebo once daily~     (QD) on an out-patient basis for the subsequent 40 weeks. Subjects will continue to receive~     the same blinded treatment (TRC101 or placebo) that they received in Study TRCA-301.~   "
13448|NCT03390829|"~     Consultations in general medical practice concerning the follow-up of the patients receiving~     opiate substitution treatments are not exceptional.~      It is nowadays agreed that addictive pathology goes far beyond the issue of product~     dependence, in favor of a pathology in itself. Centered on problems of attachment, of~     framework, of trust. The implementation of the opiate substitution treatments and the lifting~     of the product dependence appears only as a preliminary to the background work with the~     patient ex-user of opiate.~      Finally, the literature provides little information on the experience of general~     practitioners and their patients under opiate substitution treatments regarding follow-up~     consultations in the stability phase.~      The objective of this work is therefore to study the feelings on follow-up consultations,~     general practitioners and their patients under opiate substitution treatments considered~     stabilized.~   "
13449|NCT03390816|"~     Protein-energy malnutrition (PEM) is a frequent condition in patients suffering from cancer,~     especially the elderly. According to some studies, this malnutrition has important~     consequences in this population, by increasing the risk of treatment toxicities, premature~     interruption of chemotherapy, mortality and risks of complications. Identifying cases of~     malnutrition is an objective pursued by the National Nutrition and Health Programme and an~     important task of the Unités de Coordination en Oncogériatrie.~      The main goal of this study is to assess the loss of weight over the 6 month-period preceding~     the cancer treatment, regardless of kind (chemotherapy, targeted therapy, hormone therapy,~     immunotherapy, radiation therapy, surgery, comfort care), in the elderly suffering from~     cancer.~   "
13450|NCT03390803|"~     Twenty-four consecutive patients with Hemifacial spasm and 25 age and gender-matched randomly~     selected eyes of healthy volunteers underwent corneal pachymetry and intraocular pressure~     measurements using Goldmann Applanation Tonometer and non-contact tonometer. An interval of~     15 minutes was maintained between Goldmann Applanation Tonometer and non-contact tonometer~     measurements. Intraocular pressure measurements were performed before (during hemifacial~     spasm) and 2 weeks after Botox injections in Hemifacial spasm patients and in healthy~     volunteers without Botox injections. All the measurements with Goldmann Applanation Tonometer~     were carried out by a single physician while those with the non-contact tonometer were done~     by another physician who was masked to the results of the Goldmann Applanation Tonometer. All~     measurements were taken between 10:00 and 11:00 a.m.~   "
13451|NCT03390790|"~     Urodynamic testing can be associated with mild discomfort, particularly at the time of~     insertion, repositioning, and removal of the bladder catheter (a tube inserted into the~     bladder via the urethra). Few studies have investigated ways to improve patient comfort~     during this procedure. In this study, the investigators want to see if applying external~     lidocaine (a numbing gel) prior to the procedure can help to minimize patient discomfort.~   "
13452|NCT03390777|"~     Medication related Osteonecrosis of the Jaw (MRONJ) consists of progressive destruction of~     bone in the maxillofacial area. It is an established complication which occurs in patients~     who take two main classes of antiresorptive drugs: Bisphosphonates (BP) and Denosumab.~      PRGF is a autologous platelet-enriched plasma obtained from the patient's own blood. It~     contains proteins that can influence and promote cell recruitment and its beneficial effect~     could consist in improving bone and soft tissue healing. These benefits are likely to apply~     to MRONJ surgery, as it is suggested by small retrospective or prospective case series.~      This is a randomized, multi center study comparing the outcomes of surgery alone and PRGF~     plus surgery in patients requiring surgical treatment for MRONJ.~      To assess the superiority of surgery plus PRGF compared to surgery alone in patients treated~     for MRONJ. Primary endpoint for this scope is a composite of clinical or radiological~     recurrence rate of disease during a 12 months post-operative period.~      Secondary endpoints are: a) morbidity, defined as nerve injury, bleeding, vascular or wound~     complications. b) post- and peri-operative pain defined by the treated subjects according to~     a standardized VAS score c) quality of life (QoL) defined by a standardized scale.~   "
13453|NCT03390764|"~     Defects in the abdominal wall (incisional hernia) is a frequent negative outcome after~     surgery. Reinforcing the incision with mesh seem to lower the incidence but in surgery that~     includes bowel resection a simple alternative, cheaper and less prone to infection than a~     synthetic mesh, would be of interest. The primary aim of this multicentre randomized~     controlled trial is to compare the incisional hernia incidence one year after planned~     colorectal cancer surgery performed through a midline incision which is closed either by a~     standardized small stitch 4:1 technique (the incision is closed with the use of suture of 4~     times the length of the incision) or with the same technique plus a reinforced tension-line~     suture (a suture is applied in the fibrous tissue parallel to the incision which is then~     embraced by the 4:1 suture when the incision is closed). A difference in incisional hernia of~     10% (15% without and 5% with reinforced tension-line suture) is assumed. Secondary aims are~     to evaluate incidences of wound dehiscence, other wound complications and incisional hernia~     after 3 years. Furthermore we aim to evaluate costs for incisional hernia treatment during 3~     years as well as patient satisfaction and quality of life.~   "
47819|NCT02940990|"~     This protocol is a phase II multi-center randomized controlled trial (RCT) evaluating the~     efficacy of SBRT in multi-metastatic NSCLC patients who are pan-negative for driver~     mutations.~   "
13454|NCT03390751|"~     The identification of a high atropine load of treatment received during hospitalization as a~     predictor of postoperative confusion could have various benefits:~        -  Pharmacoepidemiological: identify factors associated with postoperative confusion~        -  Clinics: by favoring treatments with a low atropine load during anesthesia, the~          management of patients hospitalized in orthopedics. Similarly, stopping or re-evaluating~          treatments with a high atropine weight for scheduled surgery is an easy step to take.~        -  Socio-economic: by reducing the costs related to the occurrence of a confusional~          syndrome (over-treatment, prolonged hospital stay, loss of autonomy,~          institutionalization of patients...).~      In total, the present study would improve the daily management of hospitalized patients and~     the practices of clinicians, by offering a decision-making aid.~   "
13455|NCT03390738|"~     A phase II, open label, single arm, single agent study using nivolumab in patients who failed~     2 or more lines of previous chemotherapy for recurrent/metastatic NPC (At least 1 line should~     include platinum based chemotherapy)~   "
13456|NCT03390725|"~     The proposed study is a cluster randomized trial to test the effectiveness of a parental~     support programme in pre-school class to promote healthy dietary habits and physical activity~     and prevent obesity, delivered by teachers and school health services and in collaboration~     with primary care. The control condition is standard care in schools. The 6-month programme~     is carried out in schools in disadvantaged areas and is universal. It is based on Social~     Cognitive Theory and consists of four components: 1) Health information to parents regarding~     the child; 2) Motivational Interviewing with the parents by the school nurse concerning the~     child; 3) classroom activities for the children with home assignments; and 4) a web-based~     self-test of type-2 diabetes risk by parents, with follow-up in primary health care. The~     primary outcome is assessed as the difference between the intervention and the control group~     directly after the end of intervention at 6-months post baseline, and at follow-up 18 months~     post baseline, adjusted for baseline values. The outcome variables are the intake of~     unhealthy foods, unhealthy drinks, and healthy foods assessed by a newly developed method~     using photo-based dietary assessment. The secondary outcomes are physical activity and time~     spent sedentary measured by accelerometry, and measured BMI and waist circumference.~     Hypothetical mediator variables are parental self-efficacy and parenting practices regarding~     diet and physical activity assessed by questionnaire. Process evaluation will be performed~     through interviews and questionnaires to study how well the programme was implemented in~     terms of dose, fidelity, acceptability and feasibility. The programme is in line with the~     latest evidence regarding the prevention of childhood obesity: that schools should be a focal~     point of prevention efforts, interventions should involve multiple components, and include~     the home environment. If effective, it will fill a large knowledge gap concerning~     evidence-based health promotion practice within school health services to prevent overweight~     and obesity and in the long term reduce social inequalities in health.~   "
13457|NCT03390712|"~     The primary objective of this single-center multi-site retrospective chart review is to~     determine if paliperidone palmitate and/or risperidone long-acting injection can decrease the~     number of psychiatric relapses following their initiation in an inpatient acute psychiatric~     unit compared to oral antipsychotic therapy and determine if one treatment is superior to the~     other in this regard. This study will utilize a mirror-image design and incorporate up to a 3~     years of follow-up following the index admission. Secondary objectives of this study will be~     to determine the change in hospital resource utilization for psychiatric reasons following~     treatment initiation, and to determine the difference in time to relapse.~   "
13458|NCT03390699|"~     Patients after maxillecotmy develop gum disease and teeth decay often. these two diseases are~     caused by bacteria. In addition, these patients may have oral infections such as candida .~     The therapeutic approach now days to these diseases (dental decay and periodontal disease)~     can change following the results of the study.~      the purpose of the study is to examine whether the connection between the oral cavity and~     anatomical structures exposed by maxillectomy procedure causes a change in the level of~     microbes examined. To the best of our knowledge, there are not yet studies examined the~     clinical and microbiological changes in the oral cavity before and after surgery.~   "
13459|NCT03390686|"~     In the SAMSON-2 study, the proposed biosimilar HD204 will be compared to its reference~     product EU-licensed Avastin®. The aim of the study is to demonstrate equivalence of HD204 and~     EU-licensed Avastin® in terms of efficacy, safety, pharmacokinetics and immunogenecity.~   "
13460|NCT03390673|"~     The purpose of this study is to demonstrate that the human body breaks down and processes the~     new drug HD204 in the same way as a marketed drug (Avastin) in healthy male subjects. In~     addition, a comparison for safety and tolerability between new drug HD204 and Avastin will be~     assessed.~   "
13461|NCT03390660|"~     This is a secondary data analysis study that uses nationally representative data to examine~     the trends in breastfeeding disparities between Women, Infants, and Children (WIC) program~     eligible children vs. non-eligible children and eligible participants vs. eligible~     non-participants.~   "
13462|NCT03390647|"~     The primary purpose of this study is to evaluate the safety, tolerability, and~     pharmacokinetics of multiple oral doses of E6130 in Japanese healthy adult male participants.~   "
13463|NCT03390634|"~     Gastro-oesophageal reflux disease (GORD) is a common condition, where acid from the stomach~     leaks up into the oesophagus (gullet) and causes symptoms such as heartburn and an unpleasant~     taste in the back of the mouth. GORD can often be controlled with self-help measures and~     medication. Occasionally, surgery to correct the problem may be needed.~      A laparoscopic fundoplication is a keyhole (laparoscopic) procedure which is a highly~     effective treatment. Although reflux-related symptoms are absent or well controlled in over~     85% of patients at 5 years after the operation, younger patients may have higher expectations~     that such an operation would hopefully last decades.~      Oesophageal physiology tests such as 24-hour catheter pH (potential of hydrogen) and~     impedance involve passing a small tube into oesophagus via patients' nose to monitor the~     presence of stomach content (acid or non-acid) in the oesophagus. The manometry test measures~     the pressures and coordination of pressure activity within the oesophagus. Bravo™ wireless pH~     monitoring uses a capsule that is attached to the oesophageal lining. These tests are often~     used as part of a pre-operative evaluation before anti-reflux surgery (ARS).~      Several measurements in these tests (also called parameters) could potentially anticipate~     clinical outcomes following anti-reflux surgery. The evidence for parameters like duration of~     acid exposure, number of reflux episodes and association with symptoms, pressures and~     co-ordination of pressure activity in the oesophagus, came from studies which were not~     designed in the most rigorous way to determine whether a cause-effect relation exists between~     treatment and outcome.~      This is a single centre, retrospective, observational study in which patients who had~     pre-operative physiology testing and anti-reflux surgery at a tertiary centre in the last 10~     years will be assessed for reflux symptoms and quality of life over the phone, based on three~     validated questionnaires. The study is designed to evaluate correlations between oesophageal~     physiology parameters and symptomatic response to ARS.~   "
13464|NCT03390621|"~     In this study, the investigators will use an existing data set to examine the relationship~     between parent feeding styles and the quality of the dinner meal using the Healthy Eating~     Index.~   "
13785|NCT03386435|"~     It has been demonstrated that liver ischemia/reperfusion injury (IRI) was associated with~     poor outcomes after liver resection. Remote ischemic preconditioning (RIPC) has been shown to~     have protective effects on liver IRI. However, impact of RIPC on living donor hepatectomy has~     not been elucidated. In this study, the investigators tried to elucidate the effects of RIPC~     on postoperative liver function test after living donor hepatectomy.~   "
13465|NCT03390608|"~     Because of mammography screening increasingly more women are diagnosed with centimeter or~     subcentimeter node-negative breast cancer (i.e., T1abN0); these tumors account for~     approximately 19% of all newly diagnosed breast cancers in Sweden. Although the long term~     relapse-free survival rates among patients with such tumors is as high as ≥90%, some reports~     suggest that certain patient subgroups may have rates <75%. Firmly established prognostic and~     predictive factors for patients with T1abN0 tumors are, however, lacking. This is a~     nationwide, register-based cohort study investigating prognostic and predictive factors in~     women with centimeter or subcentimeter breast cancer. The study hypotheses are: 1)~     Established prognostic and/or predictive factors in overall breast cancer are prognostic~     and/or predictive factors also in centimeter or subcentimeter node-negative breast cancer; 2)~     The established relative reduction in risk of recurrence and death of adjuvant treatment for~     overall breast cancer are similar in centimeter or subcentimeter node-negative breast cancer.~   "
13466|NCT03390595|"~     Phase II Multicentre, randomized, open-label study to evaluate the safety and efficacy of~     avelumab with gemcitabine/carboplatin versus gemcitabine/carboplatin alone in patients with~     unresectable or metastatic urothelial carcinoma (UC) who have not received prior systemic~     therapy and who are ineligible to receive cisplatin-based therapy.~   "
13467|NCT03390582|"~     Autoimmune thyroid disease (AITD), which includes Hashimoto's thyroiditis (HT) and Grave's~     disease (GD), are the most common organ-specific autoimmune diseases and affect more women~     than men, with a female-to-male ratio from 5 to 10. Many studies have indicated that~     alterations in the gut microbiota are important environmental factors in the development of~     inflammatory and autoimmune diseases. Investigators systematically performed a comparative~     analysis of the gut microbiota in AITD patients and healthy controls.~   "
13468|NCT03390569|"~     Patients with newly-diagnosed GBM will be given personalized exercise regimes during~     concurrent chemo-radiation and up to 3 months later. Study aims are to investigate the~     feasibility and preliminary efficacy of the exercise program on progression free survival.~     Secondary outcomes of interest include cognition, fatigue, and quality of life.~   "
13469|NCT03390556|"~     The goal of this study is to evaluate a pilot of clinic-based intervention of asthma~     education. After a scheduled outpatient encounter for well-child care or asthma care has~     concluded, a pediatric nurse will teach participants (children and their caregivers) about~     asthma, provide clearly written information about how to manage asthma, and discuss how to~     manage asthma at home with cooperation between caregivers and children. Families will also~     receive current asthma prescriptions in clinic, and colored labels will be attached to~     medications in order to match the color scheme of asthma action plans (green labels for~     controller medications, red labels for rescue medications). Families will be followed for 3~     months after the first clinic visit, including a follow-up visit in clinic 1 month later and~     a follow-up telephone call 3 months after starting. The nurse will reinforce key educational~     points and review medication use at the follow-up clinic visit. Families will also be invited~     to complete an additional in-depth interview following the 1 month clinic follow-up. The~     investigator hypothesizes that knowledge, self-efficacy, and reported adherence with asthma~     medications will increase for both caregivers and children/adolescents following the~     intervention and labeling of delivered medications. In addition, the investigator~     hypothesizes that children/adolescents will have more symptom free days and improved control~     following the intervention.~   "
13470|NCT03390543|"~     The purpose of this study is to evaluate the effect of simple needle guide device for~     ultrasound-guided internal jugular vein catheterization in cardiac surgical patients~   "
13471|NCT03390530|"~     Brain bleed in premature infants damages the brain and survivors suffer from cerebral palsy~     (weakness in the extremities), cognitive deficits, and neurobehavioral disorders. In this~     clinical trial, investigators will test whether thyroxine (hormone from thyroid gland)~     treatment in premature infants with moderate-to-large brain bleeds show recovery in the brain~     structure on MRI evaluation at the time of discharge (36 weeks) and neurodevelopmental~     improvement at 2 years of age.~   "
13472|NCT03390517|"~     This is a randomized, controlled, parallel study to determine the difference in~     post-operative anastomotic leak rate of colorectal anastomosis where colon and rectal tissue~     perfusion is evaluated using fluorescence angiography with indocyanine green and without this~     method.~   "
13473|NCT03390504|"~     The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or~     pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast~     growth factor receptor (FGFR) aberrations who have progressed after one prior treatment.~   "
13474|NCT03390491|"~     The research team will develop and test a prototype version of OnTrack>An Online Role-Playing~     Game (OnTrack>The Game or OTG), an online role-playing game designed for youth and young~     adults experiencing First Episode Psychosis (FEP). Phase I showed positive changes in~     quantitative measures of hope and recovery, as well as an enthusiastic response to the~     prototype as evidenced by qualitative interviews. In Phase II, the research team will refine,~     expand and finalize OTG and evaluate the effectiveness of OTG.~   "
13475|NCT03390478|"~     A strategy involving 6 partners was planned, targeting the components of education,~     innovation, and practice-based research with knowledge transfer into clinical practice.The~     project MIND&GAIT aims to promote independent living in frail older people through the~     development of innovative initiatives and systems to improve cognition and gait ability. A~     structured and integrated Combined Intervention (CI) will be developed, composed by:~     cognitive stimulation program, an animal-assisted therapy program, a physical activity~     program. Moreover, an auto-blocking mechanism for rolling walkers will be developed and~     implemented in this study. The results of the study and all the material that was used, will~     be disseminated in a web platform.~   "
13476|NCT03390465|"~     The purpose of this study is to evaluate the Drug interaction and safety of~     Fimasartan/Amlodipine and Hydrochlorothiazide in Healthy Male volunteers.~   "
13486|NCT03390335|"~     The aims of this proposal are to test current USN procedures for adjusting decompression~     procedures during air diving at 8,000 and 10,000 ft altitude and to provide a decompression~     algorithm for no-stop dives to 100 feet of sea water (fsw) at 10,000 and 12,000 ft altitude~     using enriched O2 (PO2=1.3 ATM). Additionally, the experiments will determine whether a~     period of hyperbaric hyperoxia, such as would be experienced during a dive at altitude,~     reverses altitude acclimatization, resulting in a return of acute mountain sickness (AMS)~     symptoms.~   "
13477|NCT03390452|"~     Oral health is an important component of general health and oral cavity acts as a mirror to~     the health of individuals and communities. Inadequate focus on primary prevention of oral~     diseases, poses a sizeable challenge for numerous countries, especially low and middle income~     countries.~      Mobile phone technology is relatively new and its successes in chronic disease is well~     documented but there is little evidence available in its use for improving oral health and~     dietary habits of children.~      This will be a Pilot Randomized Control Trial (RCT) . It will be conducted in public and~     private sector schools of Quetta city, Pakistan. Study will comprise of intervention and a~     control arm. Duration of intervention is 6 months.~      In the intervention group, study participants will be the parents. School teachers will send~     oral health education and reminder messages on frequent intervals to educate children's~     parents on oral hygiene and reinforce their behaviors to improve their child oral health.~      The primary school children in the control group will not receive any intervention~   "
13478|NCT03390439|"~     As atrophic striae are common dermatological conditions. Various therapeutic modalities have~     been employed in the treatment of striae distensae, mainly in striae rubra. There are few~     studies that include the treatment of striae alba.~      The non-ablative fractionated laser and, more recently, microneedling are two distinct~     treatments, but they are widely used in dermatologist practice.~      The present randomized clinical trial is aimed at evaluating and evaluating the response of~     microneedle and fractional non-ablative laser Nd-yap 1340 in the treatment of abdominal~     striae alba.~   "
13479|NCT03390426|"~     The purpose of this prospective randomized double-blind study is to determine if the novel~     technique of ultrasound guided peri-arterial injection of local anesthetic around the femoral~     artery decreases ischemic hypertension associated with prolonged lower extremity tourniquet~     time during total ankle arthroplasty (TAA) and foot fusion surgeries. Patients will be~     randomized 1:1 to receive either local anesthetic or saline, which will be injected~     superomedially to the femoral artery in an attempt to block sympathetic afferents and~     decrease tourniquet associated hypertension intraoperatively.~   "
13480|NCT03390413|"~     The present study is a randomized clinical trial which investigates robot-assisted partial~     nephrectomy (RPN) compared to image-guided cryoablation (CA) in a number of functional,~     oncological and economic variables.~      Every year close to 1000 Danes are diagnosed with renal cell carcinoma. Approximately 25% of~     these newly diagnosed patients have a T1a tumour, thus being candidates to nephron-sparing~     surgery. Today most nephronsparing surgical procedures consists of RPN, often requiring~     temporary clamping of the renal artery rendering the kidney to a critical period of warm~     ischemia which is potentially harmful to the renal function. Image guided ablative modalities~     has emerged as a minimal-invasive alternative to partial nephrectomy. The level of evidence~     within this domain is considered to be low as the existing literature is highly influenced by~     selection bias, and as of yet no randomized trial has compared the two modalities. Especially~     with the increasing age of the patients, an approach suitable for local anaestesia is~     desirable.~      Patients from Central Denmark Region and Region of Southern Denmark who are diagnosed with a~     pT1a renal cell carcinoma that is found to be eligible for both modalities will be offered to~     enter into a randomized trial to be treated with either RPN og CA. The study's primary~     endpoint is loss of renal function 6 and 12 month after treatment. Secondary endpoint~     includes recurrence free survival 1, 3 and 5 years after treatment, readmission and~     complication rates as well as health economic evaluations.~      All patients will be pre- and postoperatively assessed with biochemistry, CT urography, CT~     thorax and glomerular filtration rate measurements.~   "
13481|NCT03390400|"~     The investigational device is an approved femtosecond laser (FSL) device with an integrated~     imaging system to perform certain steps of the cataract procedure. The FSL will perform~     anterior capsulotomy and lens fragmentation in individuals suffering from age-related~     cataract with need of cataract surgery.~      Cataract surgery will be performed in subjects who have signed an informed consent form.~     Aqueous humor will be collected and screening will be performed for Total Prostaglandin and~     Prostaglandin E2 via en-bloc Enzyme-linked Immunosorbent Assay (ELISA)-Kit.~   "
13482|NCT03390387|"~     QUESTIONS AND OBJECTIVES OF ALL-MB 2015 STUDY~        1. Will the new risk group stratification (especially of T-ALL) to improve overall and~          event-free survival?~        2. Will the new protocol is effective and feasible in patients older than 15 years, and~          especially in young adults?~        3. Whether the intermittent dexamethasone administration in induction will result in a~          decrease in toxicity and mortality without loss of efficacy?~        4. Whether the methylprednisolone administration as basic glucocorticoids during induction,~          consolidation and maintenance therapy will lead to decrease of severe infections and~          early mortality rate, improve survival and therapy compliance in adolescents and young~          adults with B-precursor ALL?~        5. Whether the administration of Bortezomib in patients with B-precursor ALL with initial~          WBC≥100,000/µl will improve treatment outcome?~        6. Whether the administration of Idarubicin instead Daunorubicin in low-risk T-ALL patients~          and two-phase induction in intermediate-risk T-ALL patients will reduce relapse rate and~          improve survival?~   "
13483|NCT03390374|"~     This study determines the effectiveness of oral nystatin as prophylaxis in order to prevent~     systemic fungal infection in very low birth weight preterm neonates. 47 participants received~     oral nystatin and 48 participants received sterile water as part of oral hygiene.~   "
13484|NCT03390361|"~     Patients with bilateral age related cataract will be included in the study. Manual cataract~     surgery (MCS) will be performed in one eye and laser cataract surgery (LCS) in the~     corresponding eye. LCS will be performed with an approved femtosecond laser (FSL) device with~     an integrated imaging system.~      After surgery aqueous humour will be collected and screened with Enzyme-linked Immunosorbent~     Assay (ELISA) Kits for Interleukin-1β; Interleukin-6 and PG.~   "
13485|NCT03390348|"~     This is a in-home observational study of 12 healthy term infants of ≤15 weeks of age to~     compare infant crying and fussing parameters documented by the LENA recorder with those~     documented via parental e-diaries~   "
13487|NCT03390322|"~     This is a multi-center, prospective, open label study of the Duodenal Glycemic Control™~     procedure on type 2 diabetes patients sub-optimally controlled, to examine the safety and~     initial performance of the DiaGone™ system.~   "
13488|NCT03390309|"~     Evaluation of A Partially Hydrolyzed Whey Protein Infant Formula in Improving Functional~     Gastrointestinal Disorders (FGIDs) Symptoms~   "
13489|NCT03390296|"~     The goal of this clinical research study is to learn about the safety and tolerability of 8~     different drug combinations when given to patients with acute myeloid leukemia (AML).~     Researchers also want to learn if these drug combinations can help to control the disease.~      The drug combinations being studied are:~        -  PF-04518600 (OX40 agonist monoclonal antibody) alone~        -  PF-04518600 and avelumab (anti-PDL1 mAb)~        -  PF-04518600 and azacitidine~        -  PF-04518600 and utomilumab (anti-41BB mAb)~        -  avelumab and utomilumab~        -  PF-04518600, avelumab, and azacitidine~        -  gemtuzumab ozogamicin (anti-CD33 mAb) and glasdegib (smoothened inhibitor)~        -  glasdegib and avelumab~      This is an investigational study. Avelumab is FDA approved and commercially available for the~     treatment of advanced Merkel cell carcinoma and urothelial carcinoma. Azacitidine is FDA~     approved and commercially available for the treatment of myelodysplastic syndrome (MDS).~     Gemtuzumab ozogamicin is FDA approved and commercially approved for the treatment of AML.~     PF-04518600, utomilumab, and glasdegib are not FDA approved or commercially available.~      It is considered investigational to use these drugs to treat AML. The study doctor can~     describe how the drugs are designed to work.~      Up to 138 participants will be enrolled in this study. All will take part at MD Anderson.~   "
13490|NCT03390283|"~     The goal of this research study is to learn how opioid medications (medications that are used~     to manage pain) are handled by the parents and/or caregivers of patients who are 18 years or~     younger. This includes information on how opioids are stored, used, and disposed of.~      This is an investigational study.~      Up to 150 participants will be enrolled in this study. All will take part at MD Anderson.~   "
13491|NCT03390270|"~     The investigators have created a new risk score that predicts whether initially stable~     patients with myocardial infarctions (heart attacks) will require intensive care while they~     are in the hospital. To evaluate how well this risk score works, the investigators plan to~     calculate this risk score for every patient that comes to the hospital with a heart attack,~     provide the risk score to the emergency room doctor treating the patient, and determine~     whether each patient required intensive care while they were in the hospital. The~     investigators will then evaluate whether giving emergency room doctors access to this risk~     score reduced costs of taking care of heart attack patients compared with previous years.~   "
13492|NCT03390257|"~     3NT flexible endoscope is a single-use disposable handheld endoscope that provides a means to~     visualize the nasal cavity and paranasal sinus space and deliver irrigation to treat the~     sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic~     procedures~   "
13493|NCT03390244|"~     This study is intended to evaluate the clinical usefulness of the FCVB in its on-label use,~     but in a different racial type than studies till now (Asians only). The device will be~     inserted in Caucasian patients with permanent loss of functional vision (visual acuity hand~     movements or less), where a permanent use of repeat silicone oil is required to maintain the~     eye pressure.~   "
13494|NCT03390231|"~     Stem Cell Educator (SCE) therapy circulates a patient's blood through a blood cell separator,~     briefly cocultures the patient's immune cells with adherent Cord Blood Stem Cells (CB-SCs) in~     vitro, and returns only the educated autologous immune cells to the patient's circulation.~     Several mechanistic studies with clinical samples and animal models have demonstrated the~     proof of concept and clinical safety of SCE therapy. They suggest SCE therapy may function~     via CB-SC induction of immune tolerance in the autoimmune T cells and pathogenic~     monocytes/macrophages when these are exposed to the autoimmune regulator protein (AIRE) in~     the CB-SCs. In this project, the optimized SCE therapy for type 1 diabetes (T1D) and T2D will~     be tested in a prospective, single-arm, open-label, single-center study to assess its~     clinical efficacy and related molecular mechanisms in patients with diabetes.~   "
13495|NCT03390218|"~     Access to effective treatment resources is a ubiquitous problem in behavioral health. There~     is a need for effective interventions that are more easily accessed at a lower cost. This~     study will compare outcomes for two models of treatment: 1) The experimental group, Therapy~     Assistance Online (TAO), and 2) the comparison group, treatment as usual.~   "
13496|NCT03390205|"~     In many diseases of the vitreo and chorioretinal complex, perfusion changes have a~     diagnostic, prognostic or causative role. The visualisation of perfusion was limited to~     invasive techniques, which were only to depict vasculature in one plane. Optical coherence~     tomography is able to visualise and quantify eye perfusion layer-specific and non-invasive.~   "
13497|NCT03390192|"~     Repetitive transcranial magnetic stimulation (rTMS) or transcranial direct current~     stimulation (tDCS) has been used for the modulation of stroke patients' motor function by~     altering the cortical excitability. Recently, more challenging approaches, such as~     stimulation of two or more sites or use of dual modality have been studied in stroke~     patients. In this study, simultaneous stimulation using both inhibitory rTMS (1Hz) and anodal~     tDCS (dual-mode stimulation) over bilateral primary motor cortices (M1s) was investigated to~     compare its modulatory effects with single inhibitory rTMS stimulation in subacute stroke~     patients.~   "
13498|NCT03390179|"~     The hyperglycemic response to surgery and the added effect of low-dose steroids~     (dexamethasone 4 to 8mg), and whether these differ in diabetics and nondiabetics remain~     unclear. Therefore, we prospectively evaluate the intraoperative and postoperative serum~     glucose concentrations in diabetics and nondiabetics that received intravenous steroid~     administration. This multicentre study include > 250 patients.Primary endpoiunt was glucose~     concentration at H6 after surgery. Secondary endpoints were glucose concentration at H12 and~     at H24 and effect of anesthesia (regional anesthesia)~   "
13499|NCT03390166|"~     The study is aim to evaluate the immunogenicity and safety with two groups of participants~     who will received a seasonal trivalent split, inactivated influenza vaccine (A/H1N1; A/H3N2~     and B) or an active comparator (licensed influenza vaccine~   "
13500|NCT03390153|"~     The purpose of this graduate student research study, is to test two different sockets for~     comfort and test what pressures are created by the socket during daily activities. The~     objective is to illustrate that semi-flexible sockets will maintain its rigidity and resist~     progressive shear forces from daily activity, ergo making our prosthetic system a more~     comfortable experience for the prosthetic user.~   "
13524|NCT03389841|"~     The study is aimed to evaluate if the education of the caregiver is able to reduce hospital~     admissions of patients with heart failure assisted at home.~   "
13501|NCT03390140|"~     The primary goal of this study is to conduct a multi-site RCT to evaluate the replicability~     and efficacy of the ReInventing Yourself after SCI intervention in improving health and~     function outcomes for persons with spinal cord injury (SCI). A total of 252 participants will~     be randomized to one of three research arms: 1) Group treatment plus workbook (Group), 2)~     individual self-study through YouTube video plus workbook (Indiv), and 3) no treatment, no~     workbook (Control). Participants randomized to the Group arm will attend 6 weekly group~     sessions led by a pair of group facilitators and will utilize the study workbook. Indiv arm~     participants will receive the workbook and will be instructed to independently access YouTube~     videos of the group session content. Control arm participants will not receive any~     intervention during the 6 week period. Participants in all three arms will be assessed at~     identical time points throughout the study: baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks,~     and 46 weeks.~      It is hypothesized that individuals in the Group intervention arm will show greater~     improvements after the six week intervention in SCI-specific and general self-efficacy,~     emotional well-being, increased societal participation, less depressive and anxiety~     symptomatology, and improved resilience than participants in the Indiv and Control arms.~   "
13502|NCT03390127|"~     The purpose of the present study is to compare the effect of PEEP on arterial oxygen partial~     pressure in elderly patients undergoing urologic surgery using LMA supreme™ in a lithotomy~     position.~   "
13503|NCT03390114|"~     The goal of this preliminary study is to determine the efficacy of an internet-based~     treatment program for insomnia for HIV-infected persons.~   "
13504|NCT03390101|"~     BCD-085 is an innovative drug, monoclonal antibody against interleukin-17. The toxicity,~     safety, and pharmacokinetics of BCD-085 was investigated in animals, in phase I clinical~     study in healthy volunteers, and in phase III clinical study in patients with moderate to~     severe plaque psoriasis. This clinical study aims at investigating the efficacy and safety of~     BCD-085 every other week regimen (after induction for first 3 weeks) versus BCD-085 one per~     month regimen (after induction for first 3 weeks) versus placebo in patients with moderate to~     severe plaque psoriasis.~      Study purpose:~      To investigate the efficacy and safety of BCD-085 versus placebo and Cosentyx® in patients~     with moderate to severe plaque psoriasis (psoriasis vulgaris)~      Study objectives:~        1. To compare the efficacy of BCD-085 every 2 weeks versus BCD-085 every 4 weeks versus~          placebo, based on the proportion of patients who achieved a PASI75, target sPGA score,~          and on other secondary efficacy measures.~        2. To evaluate the proportion of patients in each study arm who develop adverse events with~          multiple injections of BCD-085 and placebo. Compare the safety profiles of BCD-085 when~          used every 4 weeks and when used every 2 weeks.~        3. 4. To assess the immunogenicity of BCD-085 defined as the proportion of patients who~          develop anti-drug antibodies (binding or neutralizing).~   "
13505|NCT03390088|"~     This study is proposed to determined a national database of the etiologies, clinical and the~     demographic profile, using diagnostic tests and treatment of outpatients with chronic heart~     failure in Azerbaijan population.~   "
13506|NCT03390075|"~     NuVal® shelf nutrition labels rate the nutritional quality of foods on a scale of 1 (worst)~     to 100 (best). In 2014, NuVal updated their nutrient profiling system which changed the NuVal~     score on many foods. The investigators took advantage of this natural experiment to assess~     the extent to which a change in the NuVal score at a grocery chain influenced yogurt~     purchases, a category with a wide range of more and less healthy alternatives. The~     investigators supplemented the retail scanner data with a survey of consumers in stores using~     NuVal labels to obtain their experience with the labels and the extent to which they state it~     influences their purchases.~   "
13507|NCT03390062|"~     The purpose of this study is to determine the effectiveness and safety of Apatinib for~     patients with Recurrent or Recurrent High-grade Glioma.~   "
13508|NCT03390049|"~     Vulvodynia is a debilitating chronic vulvar pain lasting at least 3 months without a clear~     identifiable cause that is challenging to treat effectively. Vulvodynia is a common pain~     condition: its prevalence is estimated at 7-8% in women between the ages of 18 and 40.~     Vulvodynia that is provoked and localized to the vestibule (provoked vestibulodynia [PVD])~     appears to be the most commonly seen in clinical practice. The current treatment approach for~     PVD follows a trial-and-error strategy from one intervention to another if symptoms fail to~     remit. Treatment options include reducing vulvar irritation (e.g., by stopping the use of~     detergents), topical agents (e.g., lidocaine), oral medications, pelvic floor physical~     therapy, psychotherapy, locally injectable agents (e.g., botulinum toxin A), and surgery~     (vestibulectomy). Despite the number of available treatment options, treatment failure is~     common.~      Fractional carbon-dioxide (CO2) laser is a technology widely used in dermatology for the~     treatment of various skin conditions. It has also been found to be an effective and safe~     treatment modality for symptoms of the genitourinary syndrome of menopause. A recent pilot~     study explored the use of fractional CO2 laser for the treatment of vestibulodynia in 37~     subjects, 67.6% of which reported that their symptoms were improved or very improved~     after 3 fractional CO2 laser sessions. In addition, the subjects reported~     statistically-significant decreases in vulvar pain and dyspareunia scores. Though the results~     of this pilot study are promising, it was of small sample size and did not control for the~     placebo effect. In cases of PVD, the placebo effect has been found to have a significant~     impact on self-reported outcomes. Sham procedures, when performed correctly, can be ethically~     administered and can significantly reduce study bias.~      The primary aim of this study, therefore, is to assess the difference in vulvar pain~     intensity scores, at baseline and at 6, 12, 16, and 24 weeks post-randomization, in women~     with refractory PVD assigned to fractional CO2 laser vs sham laser. This study will provide~     information about the efficacy of this treatment modality in women with a challenging~     clinical condition. Hypothesis: Administration of 3 sessions of fractional carbon-dioxide~     laser to the vulvar vestibule of women with refractory provoked vestibulodynia will result in~     a clinically-significant greater reduction in vulvar pain intensity scores than placebo (sham~     laser).~   "
13509|NCT03390036|"~     The objective of this sub-study is to evaluate the efficacy and safety at 39 week follow up~     of a single injection of Cingal for relief of joint pain in subjects with OA of the knee who~     have not responded to conservative treatment (weight reduction, physical therapy, pain~     medications, etc.).~   "
13510|NCT03390023|"~     Focus groups for Hispanic women who are pregnant and their close family members to assess~     attitudes, barriers and cultural beliefs involved in participation in clinical trials~   "
13511|NCT03390010|"~     Several treatment strategies are emplemented to prevent post delivery hemorage and decreasing~     maternal morbidity and mortality .~   "
13512|NCT03389997|"~     The purpose of this study is to assess the duration of the viral shedding in hematology and~     oncology patients after a respiratory tract viral infection. This duration has not been much~     studied in that population whereas it is probably longer than that in immunocompetent~     patients. Thereby it may be a source of transmission amongst these immunocompromised~     patients.~   "
13579|NCT03389126|"~     An open label, single arm, Phase II study of avelumab in patients with advanced~     hepatocellular carcinoma after prior sorafenib treatment~   "
13513|NCT03389984|"~     The objective is to compare the initial skin inflammatory transcriptomic profile of psoriatic~     patient responder to Adalimumab therapy (defined as the achievement of a Psoriasis Area and~     Severity Index 75 response at 16 weeks) with the transcriptomic profile of patient~     non-responder to Adalimumab therapy (defined as the non-achievement of a Psoriasis Area and~     Severity Index 50 response at 16 weeks) to identify differentially expressed genes in order~     to define predictive markers of response to the treatment.~   "
13514|NCT03389971|"~     Acute pulmonary embolism (PE) accounts for 5-10% of in-hospital deaths. Systemic~     anticoagulation (AC) is the standard of care and thrombolysis is recommended for those at a~     higher mortality risk. Catheter-directed therapies, mainly standard infusion catheter~     thrombolysis (CDT) and ultrasound-accelerated thrombolysis (USAT), have been introduced as~     new more effective and safer treatment modalities. USAT is a modification of standard~     catheter lysis utilizing a system of local ultrasound to dissociate the fibrin matrix of the~     thrombus with simultaneous acoustic streaming of the thrombolytic agent, allowing more~     efficient thrombolysis. However, there is limited comparative effectiveness data against~     standard multi-side hole catheter infusion. More rapid clearance of pulmonary thrombus by~     USAT compared to standard CDT may prove to be clinically beneficial and cost effective.~     Alternatively, if thrombus clearance is similar, the cost of USAT may exceed the cost of CDT~     (equipment and disposables), without realization any advantage.~   "
13515|NCT03389958|"~     This is a multicenter observational study of implementation of postpartum contraceptive~     counseling and provision into the maternity care setting in Colombia, South America. The~     primary aim is to determine proportion of uptake of highly-effective contraceptive use after~     these methods become available immediately postpartum. Secondary aims include rapid repeat~     pregnancy rates, use of other types of contraception, breastfeeding continuation, and~     visualization of IUD strings after immediate postpartum placement.~   "
13516|NCT03389945|"~     The rationale behind the dural puncture epidural (DPE) technique lies in the fact that a~     dural perforation with a spinal needle purportedly creates a conduit for accelerated~     translocation of local anesthetics from the epidural to the subarachnoid space. When compared~     with conventional epidural block, it provides improved sacral block and onset of analgesia.~      Despite the benefits associated, the supportive literature remains scarce. No trial has~     determined if similar results could be obtained with a smaller needle.~      In this trial, DPE using 25- and 27-gauge (G) spinal needles are compared. The main outcome~     will be the time required to obtain a pain score ≤ 1 using a 0-10 numeric rating scale (NRS).~     The hypothesis is that that both needle sizes will result in similar onset times and~     therefore designing the current study as an equivalence trial.~   "
13517|NCT03389932|"~     Today, there are 25 million Americans with chronic kidney disease (CKD) and 660,000 patients~     in full kidney failure, the final CKD stage, known as end stage renal disease (ESRD). Over~     half of ESRD patients are Black, Hispanic, or Asian. ESRD patients must either receive~     regular dialysis treatments, by which waste is filtered from the blood by a machine, or a~     kidney transplant from a deceased or living donor. Five-year survival on dialysis is only~     40%, compared to 74% with a deceased donor kidney transplant (DDKT) and 87% with a living~     donor kidney transplant (LDKT). Despite the known health benefits of DDKT and LDKT, 70% of~     ESRD patients remain on dialysis, especially ethnic/racial minorities.~      An American Society of Transplantation (AST) Consensus Conference recently recommended that~     patients in all CKD stages should have the opportunity to learn about and decide which~     treatment option is right for them, particularly about LDKT. However, early education about~     LDKT and DDKT is inconsistent and often poor, with early stage CKD patients and ethnic/racial~     minorities even less likely to receive it.~      Through previous HRSA grants, Dr. Waterman designed the Explore Transplant@Home (ET@Home)~     video-guided education program, and found that it significantly increased LDKT knowledge and~     informed decision-making for Black and White dialysis patients in Missouri when delivered by~     mail and supported through bimonthly postcards and texting. Now based at the University of~     California, Los Angeles (UCLA), she has partnered with Kaiser Permanente Southern California~     (KPSC), an integrated learning healthcare system providing insurance coverage and~     comprehensive care to 65,000 patients in CKD Stages 3, 4 and 5 (ESRD) (24% Hispanic, 52%~     White, 15% Black, and 9% Asian; 10% Spanish-speaking).~   "
13518|NCT03389919|"~     Multipotent mesenchymal stromal cells (MSCs) participate in the formation of bone marrow~     niches for hematopoietic stem cells. Donor MSCs can serve as a source of recovery for niches~     in patients with graft failure (GF) after allogeneic bone marrow (BM) transplantation. Since~     only few MSCs reach the BM after intravenous injection, MSCs were implanted into the iliac~     spine. Preliminary results suggest that MSCs participate in the restoration of niches for~     donor hematopoietic cells or have an immunomodulatory effect, preventing repeated rejection~     of the graft. Perhaps intraosseous implantation of MSCs contributes to the success of the~     second transplantation of hematopoietic stem cells and patient survival.~   "
13519|NCT03389906|"~     The aim of this study is to use gold particles as a model compound to modulate specifically~     and selectively the function of macrophages and mast cells and investigate how this modulates~     pain and pain sensitization in the osteoarthritic knee assessed by mechanistic pain~     assessment technologies~   "
13520|NCT03389893|"~     The purpose of this study is to understand the effect that T helper 2 (Th2) blockade has on~     well-described pathophysiological features of Atopic Dermatitis (AD), for example: barrier,~     epidermal activation, dysbiosis and epidermal lipids.~   "
13521|NCT03389880|"~     The purpose of this study is to compare the post-operative anterior knee pain (AKP) between~     patellar denervation and non-patellar denervation in total knee arthroplasty with patellar~     resurfacing~   "
13522|NCT03389867|"~     The purpose of this study was to evaluate the overall efficacy and safety of Kaempferia~     parviflora in overall healthy male human subjects.~   "
13523|NCT03389854|"~     This clinical trial is designed to assess the safety, dosing, and preliminary efficacy of a~     novel penile traction device on correcting deformities relating to Peyronie's disease, a~     condition which results in penile curvature and length loss. The trial is designed as a~     randomized, placebo-controlled study with men randomized to receiving no therapy or penile~     traction therapy 30 minutes once, twice, or three times daily. The study will occur over a 3~     month period, after which an open label phase for 3 months will be conducted. Final~     assessments for adverse effects will also be assessed at 9 months.~   "
13525|NCT03389828|"~     Background:~      Sleep that does not last long and is low-quality is tied to a range of serious health issues.~     These range from obesity to early death. Research has shown that black people who are~     professionals or managers are more likely to have this kind of sleep than their white~     counterparts. Black people are also at higher risk than whites for health problems caused by~     insufficient sleep. Researchers want to learn more about why these differences exist.~      Objective:~      To study reasons for racial differences in the work-sleep relationship.~      Eligibility:~      Adults at least 25 years old who:~        -  Are non-Hispanic black or non-Hispanic white~        -  Are employed and work 38 or more hours a week~        -  Live around Raleigh-Durham-Chapel Hill, NC, or Washington, DC~      Design:~      Participants will be screened with questions. They will give sociodemographic data like job~     title, annual income level, and gender. They will give their contact information.~      Participants will have 1 study visit. They will be in a closed, private conference room. They~     will join a focus group. The focus groups will be organized by to race, gender, and~     occupational class.~      Participants will give informed consent before the focus group begins.~      During the focus group, participants will be asked about their perceptions of health in~     general, and their typical work day. They will be asked about sleep.~      Participants will also fill out a short questionnaire about their job and sleep habits.~      Focus groups will be audio recorded. The entire session will last 90 to 120 minutes.~   "
13526|NCT03389815|"~     The purpose of the study is to evaluate safety, pharmacokinetics and efficacy of WX-0593~     alone in the treatment of advanced cancer.~   "
13527|NCT03389802|"~     This phase I trial studies the side effects and best dose of APX005M in treating younger~     patients with primary malignant central nervous system tumor that is growing, spreading, or~     getting worse (progressive), or newly diagnosed diffuse intrinsic pontine glioma. APX005M can~     trigger activation of B cells, monocytes, and dendritic cells and stimulat cytokine release~     from lymphocytes and monocytes. APX005M can mediate a direct cytotoxic effect on CD40+ tumor~     cells.~   "
13528|NCT03389789|"~     Minor painful procedures are frequently performed on newborn infants and non-pharmacological~     analgesia is commonly used. As more than one analgesic method may be applied simultaneously~     in clinical practice, the relative contribution and efficacy of analgesic components still~     needs to be further elucidated. In the present study neonatal cortical brain response during~     four types of non-pharmacological analgesia (oral glucose, expressed breastmilk, maternal~     holding plus oral glucose, maternal holding plus breastfeeding) will be studied. The aim is~     to assess the differential effect of oral solutions (glucose, breastmilk), when given alone~     or in combination with maternal relationship (holding, breastfeeding). The study will test~     the hypothesis that the mother-infant relationship would improve the analgesic effect of oral~     solutions.~   "
13529|NCT03389776|"~     Endotracheal tubes (ETT) and laryngeal mask airways (LMA) are devices used to help breathing~     whilst patients are asleep for surgery. Children may have a more satisfying experience if the~     rate of of post operative sore throat (POST) and hoarseness (PH) could be reduced. The~     incidence of POST and PH may be as high as 42% in children undergoing anesthesia. ETTs and~     LMAs require inflation of a cuff after insertion to obtain a seal to a patient's airway for~     them to be effective. It is recommended that cuff pressures are checked after insertion and~     inflation with a pressure checking device but this does not occur in all routine anesthetic~     practice. Overinflation of these cuffs may cause damage to the airway by exerting pressure on~     surrounding structures. Studies have shown both children and adults to have increased risk of~     POST with higher LMA pressure. The number of times it takes to successfully insert a LMA has~     also been associated with POST as has female gender and older age.~      Similarly to LMAs, multiple insertion attempts of ETT insertion, female gender and a larger~     size are more likely to cause POST and PH.~      Although patients with uncuffed have a higher incidence of POST than those with a cuffed ETT,~     when using cuffed tubes ETT, POST occurs more often as cuff pressure increases and should~     therefore be routinely measured.~      The location of a patient's sore throat may vary. It may be intermittent or constant, or~     described as difficulty in swallowing, painful swallowing or hoarse voice and may there may~     be difference locations within the throat. In the current literature there is no one~     definition of what constitutes a sore throat or how or when it should be measured.~      The hypothesis is that occurrence and severity of POST could be determined by various factors~     other than the pressure of the cuff alone. In particular, the pressure of cuff, the duration~     of anesthesia, the airway manipulations, could all be factors determining the occurrence of~     postoperative sore throat.~      Based on the above hypothesis, Investigators planed to perform a prospective cohort study.~      Aims: to determine the occurrence and severity of post-anaesthesia sore throat in children~     undergoing surgical procedures with LMA or ETT placement.~      If clear factors are demonstrated for POST and PH in pediatric population then measures can~     be taken to reduce them and thereby improve outcome and patient satisfaction.~   "
13530|NCT03389763|"~     The aim of this randomized trial is to assess the efficacy of analgesia , compare the utility~     of Pupillary Dilatation Reflex (PRD), Surgical Pleth Index (SPI) for monitoring pain~     perception intraoperatively and their influence on intraoperative blood loss, quality of~     surgical field using Boezaart Bleeding Scale (BBS) in patients undergoing functional sinus~     surgery (FESS)~   "
13531|NCT03389750|"~     Significant public health concerns have arisen from the intravenous misuse of oxymorphone, a~     potent mu opioid pain medication. However, little is known about its abuse potential relative~     to other mu opioid analgesics. The present study is designed to examine the abuse liability~     of intravenous oxymorphone compared to other mu opioid agonists (oxycodone, morphine, and~     hydromorphone) among physically dependent opioid abusers. This inpatient study examines the~     reinforcing effects of oxymorphone and other mu opioid agonists using drug~     self-administration procedures, and assessments of subjective effects.~   "
13532|NCT03389737|"~     For the purpose of this pilot study, the investigators hypothesize that the use of the Step~     Up Your Game protocol will result in statistically significant improvements in health and~     athletic performance. The key to this is the coordination of resources from a supervising~     physician, physical therapist, trainer, dietitian, coach, competitor, role model,~     psychologist, and spiritual leader. Notably, Step Up Your Game provides resources which would~     allow patients to find or be their own physical therapist, trainer, dietitian, coach,~     competitor, role model, psychologist, and spiritual leader. The role of the supervising~     physician, however, is meant for a qualified professional, who follows the osteopathic~     approach to medicine, in which the body is treated as an integrated whole, while also working~     to prevent and treat injuries. Though not limited solely to osteopathic physicians, it is~     critical to take into account every health aim and injury in the context of the athlete and~     how these affect all aspects of participants lives.~   "
13533|NCT03389724|"~     Prevention and early detection of chemotherapy-induced cardiotoxicity in children with bone~     tumors and Acute Myeloid Leukemia by giving capoten~   "
13534|NCT03389711|"~     Identify Rheumatoid Arthritis patients diagnose within first 12 months since the beginning of~     the disease related symptoms. Initiate proper treatment according to international standards~     in order to achieve remission/low disease activity status.~   "
13535|NCT03389698|"~     Aging is the primary risk factor in aging-related dementia. An important initiating factor~     for the development and progression of cognitive impairment is disruption of the blood-brain~     barrier (BBB). BBB plays an important role in maintaining normal brain homeostasis and~     protecting neural tissues from toxins. It is hypothesized that such changes known to be~     common in aging and can be an early process that precedes Alzheimer's Disease (AD). The~     microvascular changes related to subtle BBB disruption can be measured with~     permeability-surface area (PS) derived from GRASP DCE-MRI acquired less than 10 minutes, and~     the patterns of increased PS in normal and abnormal aging are different.~   "
13536|NCT03389685|"~     The purpose of this single-center, double-blinded randomized control trial with prospective~     data collection is to assess the ability of platelet rich plasma (PRP) treatment to reduce~     the level of pro-inflammatory synovial fluid biomarkers following an acute anterior cruciate~     ligament (ACL) tear. The study will collect and analyze synovial fluid of patients presenting~     with an acute anterior cruciate ligament (ACL) tear with a second synovial fluid sampling at~     the time of surgery. It will compare synovial fluid biomarker levels between those receiving~     an intra-articular Platelet Rich Plasma (PRP) injection versus an intra-articular saline~     injection serving as a control. Post-operative clinical outcomes will also be assessed,~     including post-operative pain levels, incidence of post-operative knee stiffness and patient~     reported outcome scores.~   "
13537|NCT03389672|"~     Residency training includes positive and negative aspects. Well-trained doctors must be~     educated, but the process may bring additional risks to patients. Anesthesiologists'~     performance when conducting neuraxial anesthesia is related to their experience. We~     hypothesized that a modified neuraxial anesthesia method would improve both residency~     training and patient safety.~   "
13538|NCT03389659|"~     The study is a randomized,multicenter, double-blinded,phase III study. To explore the~     affection of vitamin D3 in combination with oxaliplatin plus fluoropyrimidine versus~     oxaliplatin plus fluoropyrimidine as first-line chemotherapy in previously untreated advanced~     or metastatic colorectal cancer.~   "
13539|NCT03389646|"~     Open-label, multicentre, prospective cohort, observational clinical trial with a~     retrospective control group to evaluate the effectiveness and safety of CERAMENTTM| G or V~     used for filling of bone defects in the tibia and / or femur shaft and/or acetabulum in~     patients scheduled for two-stage hip or knee prosthesis re-implantation for PJI or aseptic~     loosening.~      The results will be compared to a cohort of patients, which have been treated before the~     introduction of CERAMENTTM|G or V for the same indication.~      Due to the observational character of the study, there will be no patient randomization and~     the clinicians in the study will remain entirely free to decide on the treatment of the~     patients according to established clinical practice.~      Only patients for whom therapeutic strategy for the use of the product for filling bone~     defects is already planned according to local clinical practice, at the time of informed~     consent form signature, will be enrolled in this study. Thus, the decision for the choice of~     the surgical treatment, will not be influenced by the inclusion of the patient in this study.~   "
13540|NCT03389633|"~     Many risk factors contribute to the onset of atrial fibrillation. This study is specifically~     concerned with the effect of addressing these risk factors by cardiac rehabilitation on the~     risk of recurrence of atrial fibrillation following catheter ablation. A non-randomized,~     retrospective study was performed on patients treated with a catheter ablation for atrial~     fibrillation. The intervention group consisted of patients who chose to participate in the~     cardiac rehabilitation program. The control group only received standard care. The primary~     objective was to examine whether cardiac rehabilitation following the first ablation for~     atrial fibrillation resulted in a reduction of the time to or the risk of recurrence of~     atrial fibrillation or the need for a second ablation within 1 year after the first ablation.~     A Kaplan-Meier analysis was used to examine the primary objective. The secondary objectives~     of this study were to examine whether cardiac rehabilitation following the first ablation for~     atrial fibrillation had an effect on the evolution of the patients' BMI (a Mann-Whitney U~     test), the number of recurrences of atrial fibrillation (a Poisson regression) and the~     proportion of patients who need to continue treatment with antiarrhythmics 3 months following~     the first ablation (a chi-square test).~   "
13541|NCT03389620|"~     The purpose of this study is to compare two methods of giving epidural steroid injections for~     nerve pain in the arm that comes from the neck. An epidural steroid injection can be given in~     two different ways, either in the back of the spine within the neck or in the neck next to~     the nerve root going to the arm. Both are standard medical treatments. The investigators~     would like to see how effective these treatments are, and if there are any differences in~     effectiveness or safety between these two routes.~   "
13542|NCT03389607|"~     One consequence of tissue damage caused by tourniquet is ischemia-reperfusion injury.~     Short-term ischemia leads to vasodilatation and reactive hyperemia resulting in post-ischemic~     reperfusion microcirculation failure and tissue edema that extends from 30 minutes to 4~     hours.~      SCUBE-1 is a newly defined cell surface molecule. It emerges from many developing cells,~     including endothelium and platelets. Immunohistochemical demonstration of subendothelial~     matrix deposition in atherosclerosis in humans. We did not find any study that showed the~     post-ischemic regression of scube 1, which was shown to be significantly higher in ischemic~     events in the literature.~      in this study is aimed to investigate the location / sensitivity of SCUBE-1 in diabetics and~     nondiabetics after application of regional anesthesia for ischemia-reperfusion injury induced~     by tourniquet application in knee prosthesis attempts in our aimed patients and compare this~     with other total antioxidant capacity (TAC) and MDA of ischemia-reperfusion parameters~   "
13543|NCT03389594|"~     Accuracy Of CBCT affected by many factors. On of the most factors the affect the image~     quality is voxel size. Larger voxel size give a higher accuracy of the images but with higher~     radiation dose.~      The study is to assist the accuracy of surgical guides designed from CBCT with different~     voxel sizes .~   "
13580|NCT03389113|"~     The purpose of this study is to investigate the effect of the whole body vibration exercise~     on cortical activity and consciousness Level in brain injury patients with minimally~     conscious state.~   "
14645|NCT03375242|"~     The objective of this surveillance is to collect information about 1) adverse drug reaction~     not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug~     reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy~     of this drug.~   "
13544|NCT03389581|"~     In the majority of patients, anxiety and fear are observed at different levels before~     surgery. Preoperative anxiety was reported in 60-80% of the patients who underwent surgery.~     This anxiety and fear can be attributed to many factors. Some of these are mainly anesthesia,~     previous experience of the patient, personality traits, concerns about surgical intervention,~     and postoperative pain. Patients' anxiety levels can be influenced by a variety of factors,~     including previous experience, type of hospital arrival, sex, age, and type of~     surgery.Anesthesia-related awareness among the experiences of anesthesia is described in the~     literature. In a study of 20,402 patients in the United States, the awareness rate was 0.13%.~     Being aware is that the patient is awake during the surgery and recalls seeing bad dreams. At~     that time the patient could not specify this because he was immobile. Being awake is that the~     patient is awake and showing it through his movements. The patient may not remember this~     situation later. It is a condition that can always be overlooked in previous experience,~     which is an important parameter of anxiety in the preoperative period. The patients included~     in the study were planned to use the modified Brice awareness score, first mentioned in 1970~     as the name of the person who used the anesthesia and anesthesia for awareness. In this~     study, investigators aim to reveal the effect of anesthesia awareness on preoperative anxiety~     in patients with previous anesthesia story.~   "
13545|NCT03389568|"~     This study applies an one-group pre-posttest design. Primary family caregivers of ICU~     patients are recruited. After obtaining an informed consent form from each participant, he or~     she participates in an individual 1-hour singing-based music therapy intervention. At pre-~     and posttest, the changes in the level of depression, anxiety, and emotional states are~     measured.~   "
13546|NCT03389555|"~     In this study, we aim to determine whether the combination of Ascorbic Acid (Vitamin C),~     Thiamine (Vitamin B1), and Corticosteroids improves the trajectory of organ failure and~     reduces mortality in patients with sepsis and septic shock as compared to placebo.~   "
13547|NCT03389542|"~     Degenerative mitral regurgitation (MR) due to leaflet prolapse is frequent and can be~     surgically repaired in the vast majority of patients. Despite the efficacy of mitral valve~     repair, an ongoing international controversy exists regarding the need to perform early~     surgery in asymptomatic patients with severe MR and no sign of LV dysfunction in whom the~     probability of successful and durable repair is very high. In this group of patients,~     differing views of the risks of uncorrected severe MR exist: considered as benign by those~     supporting medical watchful waiting or associated with significant excess~     mortality/morbidity by those advocating early surgery. This controversy can only be resolved~     by a randomized controlled trial which is still lacking.~      The main objective is to demonstrate the superiority of early mitral valve repair in patients~     with asymptomatic severe MR due to leaflet prolapse compared to an initial conservative~     management in terms of all-cause death and cardiovascular morbidity during five years~     follow-up.~   "
13548|NCT03389529|"~     The purpose of this study is to investigate the change of cholesterol efflux capacity in~     patients with coronary artery disease treated with secondary prevention drugs, and the~     correlation with the prognosis.~   "
13549|NCT03389516|"~     It is widely accepted that breast milk is the optimal source of infant nutrition. Despite the~     World Health Organization (WHO) recommendation of exclusive breastfeeding for the first 6~     months of infant life, many women discontinue breastfeeding as a result of perceived~     difficulties. In Israel, 88.4% of mothers declare about their intentions to breastfeed. Only~     70.9% are still breastfeeding 2 months postpartum. Nipple pain is a highly prevalent,~     significant reason for breastfeeding cessation.~      In the past, we encouraged wound healing nipples by drying (air drying; sun; other heat~     source). It turned out that this drying only delays the healing due to lack of moisture,~     causing cracks in the outer layer of the nipple. Today, nipple wound care needs treatment~     approaches consistent with wounds treatment in other body parts (moist wound healing), and~     which also addresses reduction of pain. Studies have shown that the preservation of moisture~     accelerates healing and allows epithelization.~      In the past couple of years, the Nursicare therapeutic breastfeeding pads have become a~     commonly used option for sore nipples. Nursicare pads enhance moist wound healing and soothe~     traumatized tissues, localize the inflammation, reducing wound pain and providing comfort at~     the wound site. This solution seems to be more efficient, and pads can be removed with~     virtually no pain and no remnants on the nipple that might cause concerns for allergic~     reaction for the infant.~      In this clinical trial we attempt to compare between the 2 treatments: Lanolin ointment and~     Nursicare therapeutic breast pads among postpartum mothers dealing with sore nipples and to~     examine the effectiveness of each treatment for short term (period till primary pain relief)~     and long term (total period for wound closure).~      Study hypothesis is that Nursicare provides better pain relief and faster healing that~     Lanolin.~      Method The trial will include postpartum mothers in Laniado Hospital in Natanya and mother~     from Halav M breastfeeding clinic in Olesh, Israel who had complained of nipple pain with~     any sign of nipple trauma to one or both nipples.~      The participants will be randomly selected to each group:~        1. Treatment with the Nursicare therapeutic breastfeeding pads.~        2. Treatment with application of Lanolin. A total number of participants: At least 50~          mothers randomly chosen to each group will be recruited for this trial (p).~          Randomization will be based on natural arrival sequence - where every other mother will~          be placed on 'Nursicare group' and the alternate every other mother will be placed in~          'control/Lanoline group). The only exception for this is when a certain treatment is~          already started - in those cases the patient will continue that treatment and~          compensation will be done to the sequence of allocation process.~   "
13550|NCT03389503|"~     This trial will compare the procedural success rate between right and left radial approach in~     patients undergoing coronary angiography and coronary intervention.~   "
13551|NCT03389490|"~     This is a 24 week, multicentre, prospective, randomized, controlled, parallel-designed (1:1)~     pilot study.The study will compare glycemic variability in patients treated with insulin~     glargine U300/ml insulin versus conventional (NPH) insulin using a self titration~     algorithm.50 type 2 diabetes patients who are newly started on insulin will be recruited.~     They will be randomly allocated to either insulin glargine U300 or NPH insulin for 26 weeks.~     All subjects will follow a insulin-self titration algorithm. The study will consist of 9~     visits over 26 weeks. Blood glucose variability will be collected by CGM for 7 consecutive~     days at baseline (week -1) and at week 24.Secondary endpoints other than data on glycemic~     variability, including HbA1c, fasting plasma glucose, inflammatory markers will be measured~     during three periods (week 0, week 12 and week 24).~   "
13552|NCT03389477|"~     The purpose of this study is to evaluate the results of treating patients with HPV-unrelated~     head and neck squamous cell carcinoma with neoadjuvant single-agent palbociclib, followed by~     chemoradiation (either cisplatin + IMRT or cetuximab + IMRT depending on patient~     characteristics), followed by adjuvant single-agent palbociclib.~   "
13553|NCT03389464|"~     The aim of the present study is to investigate whether confronting depressive patients with~     their dysfunctional core beliefs via a computer program results in a reduction of the~     patients' dysfunctional beliefs. Patients will be presented with a virtual agent confronting~     them with their dysfunctional core beliefs (e.g. You are worthless). Participants will be~     instructed to contradict these virtual agents (e.g. That's not true, I'm a wonderful~     person).~   "
13554|NCT03389451|"~     This study investigates if a new drug (PSMA) makes prostate cancer easier to identify in~     positron-emission tomography (PET) imaging. If this works, prostate cancer treatments can be~     prescribed that match the location of the disease. PSMA is radiolabeled with Gallium-68~     (Ga-68). This means a participant receives a small dose of radiation from the drug - less~     than the annual radiation limit for a medical worker.~      To test this new drug, participants will receive an injection of Ga-68 PSMA and then have a~     PET scan. This PET scan, and the reported results, will be entered into the medical record~     and shared with the treating oncologists.~   "
13555|NCT03389438|"~     Autologous cellular immunotherapy is to collect patient's own immune cells and infuse back~     into the patient's body after culture in vitro that can activate the anti-tumor immune~     response and achieve the purpose of cancer treatment. Central memory T (Tcm) cells are~     effective anti-tumor immune cells with long-term in vivo survival and self-renewal capacity.~     Combination of autologous Tcm cells immunotherapy with other therapies, such as surgery and~     chemotherapy, can effectively prolong the patient's life, prevent the recurrence and~     metastasis of cancers, and improve the quality of life of patients.~      This study will recruit patients with pathologically and radiographically confirmed~     metastatic bladder urothelial carcinoma that the efficacy is evaluated as partial response~     (PR) or complete response (CR) after 4 cycles of the standard first-line gemcitabine plus~     cisplatin chemotherapy. Patients must have adequate hematologic and end-organ function,~     performance status and no contraindications to receive autologous Tcm cells immunotherapy.~     All participants will be treated with standard first-line gemcitabine plus cisplatin~     chemotherapy before enrolment.~      This clinical trial was designed with a single-center randomized controlled trial. The study~     will recruit 56 patients that will be divided into treatment group and control group as 1:1~     according to the randomization. Patients of treatment group will be treated with twice~     autologous Tcm cells immunotherapy after chemotherapy. These patients will be infused in~     2-4×10^9 cells/100 ml after chemotherapy for 1 month, then cells will be infused as the same~     dose after another month. All patients will be followed up with hospital visits and telephone~     interviews to second-line treatment for disease progression. The observation period of~     patients is 24 months.~      The objective of the study is to evaluate the clinical efficacy and safety of autologous Tcm~     cells immunotherapy in patients with metastatic bladder epithelial carcinoma treated with~     first-line gemcitabine plus cisplatin according to the progression-free survival (PFS) and~     overall survival (OS) of these patients.~   "
13556|NCT03389425|"~     The objective of this study is to assess feasibility of the application of an adapted~     version, with permission, of Dr. Cenk Tek's Simplified Intervention to Modify Physical~     activity, Lifestyle, and Eating behavior (SIMPLE Program), at Pathways to Housing in Calgary,~     Alberta.~      Dr. Tek and his colleagues reviewed the literature and eloquently summarized how individuals~     with severe mental illness, particularly schizophrenia and schizoaffective disorder are~     disproportionately affected by obesity and its cardio-metabolic sequelae leading to markedly~     reduced longevity and increased healthcare costs. Most new antipsychotic medications, which~     are credited for significant advances in patients' quality of life, appear to induce further~     weight gain, compounding the problem of obesity and related medical morbidity and mortality.~     In addition to the weight gain associated with psychiatric medications, sedentary life style,~     lack of availability of healthy food options, poverty, low level of physical activity,~     cigarette smoking, and inadequate knowledge or understanding of health maintenance, appear to~     contribute to the increased obesity rates and poor health in the severely mentally ill.~      Dr. Tek and colleagues reviewed the available literature on weight loss interventions in~     individuals with severe mental illness. Despite the overwhelming problems related to obesity,~     Dr. Tek's team found that research on obesity interventions for persons with schizophrenia is~     relatively neglected and that there were no treatments that were convincingly shown to be~     effective for weight reduction in this population with unique needs. Sensing a major societal~     gap, they decided to create their own weight loss intervention specifically for individuals~     with severe mental illness. Toward this aim, they collaborated with Dr. Kelly Brownell who~     created the Lifestyle, Exercise, Attitudes, Relationships, and Nutrition or LEARN Program.~     This multi-faceted program is designed to promote positive changes in motivation, attitude~     and deeply ingrained habits that will lead to long lasting weight loss. Brownell's LEARN~     program is a self-directed weight loss program that empowers the user to make lifestyle~     changes. Dr. Tek and his colleagues modified and built upon the program by creating the~     Simplified Intervention to Modify Physical activity, Lifestyle, and Eating behavior or SIMPLE~     program specifically for individuals with severe mental illness~     (http://www.simpleprogram.org/).~      The SIMPLE program is a group weight loss intervention designed for obese patients with~     schizophrenia or schizoaffective disorder. Dr. Tek and his team piloted their modified weight~     loss program and published their findings in 2007. Their preliminary study yielded greater~     weight loss than any of the published randomized controlled trials for a chronic and stable~     schizophrenia sample, and was the only study to show continued weight loss after the~     intervention ended. These early results prompted a new larger randomized controlled trial~     with the largest sample studied to date, an extended period of follow-up, and more detailed~     testing of the effects of weight loss on schizophrenia symptoms, quality of life, and~     laboratory markers of obesity related illness risk over a period of up to 16 months.~     Preliminary results of this trial show significant, sustained weight loss.~      The goal of this study presented for ethics review, is to apply Dr. Tek's 16-week~     intervention to a small group of patients at the Pathways to Housing program in Calgary,~     Alberta. The study coordinator will use Dr. Tek's published manuals, giving full~     acknowledgment to the authors, to create weekly supportive educational sessions for the group~     of patients. Three Pathways to Housing staff members, who regularly create education groups~     for Pathways to Housing patients during a weekly lifestyle group, will sit in on each~     session. Weight (to calculate BMI) and waist circumference will be measured weekly. There~     will be no control group. The proposed feasibility study is designed to fit seamlessly within~     existing frameworks at Pathways to Housing.~      Upon completion of the study, we will convene a debriefing session with both the participants~     and the three Pathways to Housing staff to learn whether patients found the intervention~     valuable, and whether staff members feel capable of implementing the program on their own~     going forward. If the program is found to be feasible, the materials created will be~     available for future use by the multidisciplinary team at Pathways to Housing.~   "
13557|NCT03389412|"~     The aim of this study is to investigate the importance of clinical characterization of~     children with monosymptomatic nocturnal enuresis (MNE) in order to improve treatment~     efficacy.~      The hypothesis is that clinical characterization by measurement of nocturnal urine production~     and maximal voided volumes in children with MNE and subsequent treatment tailoring improves~     the response to first-line treatment approach.~   "
13558|NCT03389399|"~     To estimate the incidence of Early Onset Pulmonary Events (EOPEs), defined as the proportion~     of participants with a peak reduction in DLCO of 20% or greater after commencing brigatinib~     at 90mg QD.~   "
13559|NCT03389386|"~     The congestive heart failure (HF) is a condition associated with substantial morbidity,~     mortality, and high healthcare expenditures. From the pathophysiological standpoint, several~     mechanisms contribute to the progression and dysfunction of the failing heart such as an~     increased hemodynamic overload, impaired myocyte calcium cycling, upregulated apoptotic~     activity, deficient or increased production of extracellular matrix, genetic predilections~     and, finally, excessive neurohumoral stimulation. The vasoactive neurohumoral systems such as~     sympathetic nervous system, renin-angiotensin-aldosterone system (RAAS) and arginine~     vasopressin (AVP) system all play a role in maintaining volume and circulatory homeostasis in~     the situation of impaired cardiac output.~      Catestatin (CST), on another hand, is a novel endogenous peptide cleaved from chromogranin A~     (CgA) that is involved in regulation of cardiac function and arterial blood pressure. The~     role of this peptide is to elicit potent catecholamine release-inhibitory activity by acting~     at the level of the nicotinic acetylcholine receptors. Therefore, the main hypothesis of this~     study is that the observed plasma CST levels will reflect the degree of neurohormonal~     activation in HF, showing a significant relationship with the degree of disease severity~     (according to NYHA classification). The investigators expect that among participants with~     worst clinical phenotypes of HF, CST levels in plasma will be highest and will decrease as~     the disease severity decreases. Secondly, the investigators expect to observe the significant~     correlation between CST levels in plasma with the echocardiographic parameters of the~     ventricular function, both in terms of systolic and diastolic cardiac function. Parameters of~     inflammation, NT-proBNP levels and basic hematologic/biochemistry indices from peripheral~     blood will also be obtained and analyzed from all the participants enrolled in the study.~     Furthermore, according to the latest European Society of Cardiology (ESC) guidelines,~     participants with established congestive HF will be prospectively stratified in three~     categories in respect to their left ventricular ejection fraction (LVEF) - HFrEF, HFmrEF,~     HFpEF. All the examined echocardiographic and blood parameters will be recorded and compared~     with respective healthy and matched control participants while participants diagnosed with HF~     will additionally be analyzed for potential differences between subgroups according to their~     LVEF value.~   "
13560|NCT03389373|"~     Specific Aims~        1. Assess CG (Cariogenic) Saliva-Check Mutans® saliva testing for identification of high~          caries risk patients~        2. Explore the topical effects of PreviDent® 5000 Plus toothpaste (FDA approved drug) on MS~          counts and plaque scores in high risk children after 4-6 week.~        3. Examine the effects of frequent hygiene reminders (two phone call follow-ups) on caries~          causing bacterial counts and plaque scores in high risk children after 4-6 weeks.~   "
13561|NCT03389360|"~     , the study aimed at assessing the frequency of rising procalcitonin associated with~     infectious complications in immunosuppressed LDLTRx.~   "
13562|NCT03389347|"~     This pilot clinical trial studies whether using high throughput drug sensitivity and genomics~     data is feasible in developing individualized treatment in patients with multiple myeloma or~     plasma cell leukemia that has come back or does not respond to treatment. High throughput~     screen tests many different drugs that kill multiple myeloma cells in individual chambers at~     the same time. Matching a drug or drug combination to a patient using high throughput screen~     and genetic information may improve the ability to help patients by choosing drugs that work~     well for their disease.~   "
13563|NCT03389334|"~     The purpose of this graduate research study is to explore the therapeutic benefits of~     Myofascial Release massage on lower limb amputees with pain levels, range of motion, and~     muscle strength.~   "
13564|NCT03389321|"~     Both macitentan and riociguat are indicated in the treatment of pulmonary arterial~     hypertension (PAH) and may be administered concomitantly. The primary objective of this study~     is to evaluate the effect of macitentan administered for 11 days on the pharmacokinetics (PK)~     (i.e., amount and time of presence in the blood of riociguat) of a single dose of riociguat~     in healthy male subjects.~   "
13565|NCT03389308|"~     The primary objective of this study is to evaluate the long term safety and tolerability of~     Diacerein 1% Ointment for 2 treatment cycles in subjects with EBS that were previously~     enrolled in studies CCP-020-301 or CCP-020-101.~   "
13566|NCT03389295|"~     To determine the efficacy and safety of sequential chemoradiotherapy with regimen of~     docetaxel, cisplatin and fluorouracil and reduced target delineation radiotherapy for~     patients with locoregionally advanced nasopharyngeal carcinoma~   "
13567|NCT03389282|"~     The pilot trial evaluates the use of modified Schirmer strips and is designed to evaluate~     inter-individual range of metabolites in tear film.~   "
14667|NCT03374956|"~     The researchers are trying to identify the specific characteristics (phenotypes) that may be~     useful to help select the right medication for weight loss.~   "
13568|NCT03389269|"~     In the present study, the investigators aim to investigate postprandial physiology in~     patients who have had the Aspire Assist® inserted. This will involve a standardised mixed~     meal test (MMT) with subsequent aspiration of gastric content compared to MMT without~     aspiration. Furthermore, a comparison will be made between the aspiration group and a control~     group in order to evaluate whether continuous treatment with aspiration therapy affect the~     postprandial physiology. The primary outcomes of the trial are differences in postprandial~     plasma/serum glucose, insulin and gut hormone excursions during MMT with and without~     aspiration. Secondary outcomes encompass evaluation of satiety, gastric emptying and~     gallbladder motility following MMT with and without aspiration. Also, food intake during a~     subsequent ad libitum meal will be evaluated.~   "
13569|NCT03389256|"~     This phase 2 study is designed to evaluate the safety and activity of apatinib,a tyrosine~     kinase inhibitor that selectively inhibits the vascular endothelial growth factor receptor-2,~     in combination with EGFR-TKI in NSCLC with T790M-negative after the failure of EGFR-TKI~     therapy.~   "
13570|NCT03389243|"~     The aim of this randomized trial is to assess the efficacy of preemptive analgesia using~     paracetamol or metamizole or both of them under SPI-guided anaesthesia for vitreoretinal~     surgery (VRS), presence of PONV (postoperative nausea and vomiting) and oculocardiac reflex~     (OCR) and compare Numerical Rating Scale (NRS) with Surgical Pleth Index (SPI) for monitoring~     pain perception postoperatively.~      Patients will receive general anaesthesia combined with either preemptive analgesia using~     preemptive intravenous infusion of 1,0 g of metamizol or preemptive intravenous infusion of~     1,0 g of acetaminophen or both of them together.~   "
13571|NCT03389230|"~     This phase I trial studies the side effects and best dose of memory-enriched T cells in~     treating patients with grade II-IV glioma that has come back or does not respond to~     treatment. Memory enriched T cells such as HER2(EQ)BBζ/CD19t+-expressing Tcm may enter and~     express its genes in immune cells. Immune cells can be engineered to kill glioma cells in the~     laboratory by inserting a piece of deoxyribonucleic acid (DNA) into the immune cells that~     allows them to recognize glioma cells. A vector called lentivirus is used to carry the piece~     of DNA into the immune cell. It is not known whether these immune cells will kill glioma~     tumor cells when given to patients.~   "
13572|NCT03389217|"~     Pain is a common symptom experienced by people with MS and can significantly interfere with~     participation in the activities of daily living and adversely affect health-related quality~     of life. Pain in people with MS has the potential to become chronic, as a consequence of~     neuronal reorganization. Transcranial Direct Current Stimulation (tDCS) promotes the~     modulation of brain activity and its prolonged and continuous application can effect plastic~     modification. Combining tDCS with rehabilitation treatment may have effect in reducing pain~     in people with MS. This is a pilot randomized control trial to test the effects of tDCS in~     MS-related pain rehabilitation, its efficacy on pain (intensity, quality, interference with~     physical functioning), catastrophizing, emotional functioning and quality of life.~     Furthermore, we will explore the effects on pressure pain threshold and EEG recording.~     Correlations between sample characteristics and pain features will be investigated.~     Considering role of tDCS on neuropsychological functions, selective attention will be~     assessed.~   "
13573|NCT03389204|"~     Surgical treatments can cause late effects influencing activity of daily living, physical~     activity, and overall health. Late effects include persistent pain reported by 30 - 50% of~     women that underwent breast operations, restrictions of arm and shoulder movement were~     reported in 35% of patients, lymphedema in 15 - 25% of women who undergo axillary lymph node~     dissection and in about 6% of women who undergo sentinel lymph node biopsy. Lymphedema~     results in physical impairments including compromised function, diminished strength, fatigue,~     and pain in the affected arm . The axillary web syndrome is a self-limiting and frequently~     overlooked cause of significant morbidity in the early postoperative period after breast~     cancer, which is characterized by axillary pain that runs down the medial arm, limited~     shoulder range of motion (ROM) .~      Physiotherapy and exercise in the postoperative period can result in a significant~     improvement in shoulder ROM in women treated for breast cancer, Additionally, exercises are~     an effective intervention to improve quality of life, cardiorespiratory fitness, physical~     functioning and fatigue in breast cancer patients. However, in the postoperative period~     consideration should be given to the early implementation of exercises because of the~     potential for seroma and increases in wound drainage volume and duration.~      There is limited evidence on the influence of postoperative physiotherapy intervention, and~     instruction program on upper limb range of motion and return to physical activity divided by~     the type of surgery and regarding complications.~   "
13574|NCT03389191|"~     This project is designed to test the hypothesis that acyclovir is clinically useful for~     patients with refractory viral uveitis.~   "
13575|NCT03389178|"~     The investigators´ main hypothesis is that prenatal stress (PS)- induced programming during~     fetal and postnatal development is reflected in epigenetic and autonomic nervous system (ANS)~     biomarkers which can be harnessed for early detection and follow-up of affected children. By~     integrating multiple non-invasively obtainable sources of information using novel epigenetic,~     electrophysiologic and statistical approaches, the trial could yield progress in~     maternal-fetal medicine, offering a more precise and truly personalized prediction and new~     possibilities for designing interventions to improve neurodevelopmental outcomes of pregnancy~     affected by PS.~   "
13576|NCT03389165|"~     The aim of this study was to identify the assistance effect of the new wearable hip assist~     robot, gait enhancing mechatronic system (GEMS) developed by Samsung Advanced Institute of~     Technology (Samsung Electronics Co, Ltd., Korea) during stair ascent by comparing the energy~     expenditure of elderly adults with and without the GEMS.~   "
13577|NCT03389152|"~     This study is a multicenter individual patient-based meta-analysis that will assess the~     performances of liver stiffness measurements performed with supersonic shear imaging~     shearwave elastography (SSI-SWE) in patients with liver fibrosis to predict progression of~     chronic liver disease.~   "
13578|NCT03389139|"~     Neonatal adaptation to extrauterine life has many physiological changes in neonatal organ~     systems. These adaptative changes may be affected such as type of delivery and anesthesia~     management at birth. near infrared spectroscopy (NIRS) is a popular non-invasive method that~     can be used in newborns thus monitorize tissue oxygenation regularly. In this study we have~     purposed to compare the effects of general anesthesia versus spinal anesthesia on newborn's~     cerebral and renal oxygenation in elective cesarean operations~   "
13581|NCT03389100|"~     This is a single center brain Positron Emission Tomography (PET) study of 18F-MK-6240.~     Eligible participants are persons from Northern Manhattan who self-identify as Hispanic,~     non-Hispanic Black, or Non-Hispanic White, who are 55 to 69 years of age, of both sexes,~     without dementia, who have already agreed to undergo, of have undergone, brain amyloid PET~     and magnetic resonance imaging (MRI). Those eligible will have one brain PET scan with~     18F-MK-6240, repeated after 18 months to 30 months. Vital signs will be checked prior to~     injection of 18F-MK-6240 and again at the completion of the PET scan. The primary objective~     is to relate diabetes status and glycemia to in-vivo brain tau accumulation, across and~     within ethnic and racial groups.~   "
13582|NCT03389087|"~     The purpose of this study is to confirm the safety and efficacy of Apatinib Plus Etoposide~     Capsule as the Therapy of Advanced Small Cell Lung Cancer.~   "
13583|NCT03389074|"~     In this study, we identify the optimal AI value for achieving good acute outcomes in PVI.~      Through the Phase 1 study, we will prospectively analyze data including ablation parameters,~     AI and acute outcomes of 20 patients performed PVI with conventional ablation strategy~     (AI-blinded). After Phase 1 study results, optimal target AI value for each predefined PV~     segment will be determined. Then, by applying optimal AI values derived from the Phase 1~     study, we will evaluate the feasibility of the AI-guided procedure and verify the optimal AI~     value for acute PVI outcomes in the prospectively enrolled patients (n = 30) in the Phase 2~     study.~   "
13584|NCT03389061|"~     Epclusa® is a pan-genotypic, once-daily tablet for the treatment of chronic hepatitis C virus~     (HCV) infection containing the NS5B- polymerase inhibitor sofosbuvir (SOF, nucleotide~     analogue) 400 mg and the NS5A inhibitor velpatasvir (VEL) 100 mg.~      For patients with swallowing difficulties, administration of whole tablets can be~     problematic. In addition, HCV patients that are hospitalized (at intensive care units) due to~     severe illness (co-infections/ liver failure) might not be able to swallow medication.~     Therefore it is useful to know whether it is possible to administer SOF/VEL through a~     different route, like a feeding tube.~      In daily practice, information about the safety and efficacy of crushed tablets is lacking~     which might result in interruption or discontinuation of expensive HCV therapy. However, it~     is not recommended to interrupt treatment because there is no evidence about the efficacy of~     the therapy after discontinuation (and restart).~      Currently, patients and healthcare professionals are crushing SOF/VEL tablets without~     information about efficacy and safety. Depending on the biopharmaceutical characteristics of~     a drug formulation, crushing tablets can lead to altered pharmacokinetics of drugs.~      It is important to know whether pharmacokinetic parameters are influenced by crushing of~     tablets; both a decrease and an increase in exposure may occur. A decrease of the plasma~     concentrations of SOF and/or VEL potentially reduces the therapeutic effect of the drugs.~     Higher doses or switching to other HCV-drugs might be needed. In contrast, in case a higher~     Cmax,ss and/or exposure occurs there might be an increased risk of toxicity.~      As a result, crushing the drug is a contra-indication based on the available data.~      Therefore this study will be conducted to investigate whether a crushed SOF/VEL tablet is~     bioequivalent to SOF/VEL as a whole tablet.~   "
13585|NCT03389048|"~     Performance assessment of the PMD-200, a novel pain monitor, in subjects with degenerative~     lumbar spine disease who requires surgical procedure~   "
13586|NCT03389035|"~     This is a single arm, open-label, multi-center, phase 1-2a study to determine the Maximum~     Tolerated Dose and/or the Recommended Phase 2 Dose and the safety of CARCIK-CD19 in adult and~     pediatric patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.~   "
13587|NCT03389022|"~     The aim of this study was to evaluate an effect of pre - incisional single injection of~     low-dose ketamine on postoperative pain after remifentanil infusion in patients undergoing~     laparoscopic gastric bypass and gastric plication surgery. Ketamine is an old general~     anaesthetic. Low doses of it might be used as a adjunct in postoperative analgesia.The~     investigators expect that the low-dose ketamine reduces postoperative pain after bariatric~     surgeries.~   "
13588|NCT03389009|"~     Detection if there is association between spasm of accommodation and smart phone abuse by~     ultrasound biomicroscopy on anterior segment of the eye~   "
13589|NCT03388996|"~     This case-control study aims to compare the pelvic microbiomes of benign ovarian diseases and~     ovarian malignancies by 16s RNA techniques and culture. Discharges/flushing fluid from~     vagina, faces and fimbria end of fallopian tube are collected from age and menopausal status~     matched patient before and during procedures of laparoscopies. The discharges/flushing fluid~     would be sent for 16s RNA analysis and microculture respectively, and the results would get~     self-contrasted comparison and case-control comparison.~   "
13590|NCT03388983|"~     Lumbar spinal stenosis (LSS) is a common spinal disease that leads to pain and disability.~     LSS is defined as lower extremity and perineal symptoms (e.g. intermittent neurogenic~     claudication/numbness) that may occur with or without low back pain and that is attributed to~     congenital or acquired narrowing of space available for the neural and vascular tissues in~     the lumbar spine. Patients with LSS,who do not respond to conservative treatments after 3~     months or more, will be eligible for spinal decompression surgery in order to improve~     functional outcomes.~      While various studies have shown that preoperative exercises (prehabilitation) may benefit~     patients receiving different surgeries (e.g, abdominal surgery, anterior cruciate ligament~     reconstruction), little is known regarding the effect of prehabilitation for patients~     undergoing LSS surgery.~      The aim of the current randomized controlled trial is to compare the effectiveness of a~     6-week prehabilitation program with usual preoperative care in improving multiple outcomes of~     patients undergoing LSS surgery at baseline, 6 weeks after baseline evaluation, and at 3 and~     6 months postoperatively. It is hypothesized that prehabilitation will yield significantly~     better pre- and post-operative clinical outcomes as compared to usual preoperative care.~   "
13591|NCT03388970|"~     In order to determine the effectiveness and safety of early vitamin K1 use in reducing the~     risk of bleeding and improving prognosis in patients with spontaneous intracerebral~     hemorrhage. Patients with spontaneous intracerebral hemorrhage (excluding rupture of aneurysm~     and vascular malformation) will be randomly divided into experimental group and control~     group. All the patients in the two groups were treated according to the guideline of~     spontaneous intracerebral hemorrhage. Patients in the experimental group was treated with~     intravenous injection of vitamin K1 20mg once a day for 2 days after admission, and the~     patients in control group was treated with normal saline as a control. The hematoma volume,~     coagulation function, platelet levels and GCS scales of the two groups will be recorded in~     0d, 1d, 3d, 7d post bleeding stroke, furthermore, length of ICU stay and total~     hospitalization, incidence of complications during hospitalization are to be recorded. During~     the follow-up, mRS score will be recorded at 1m and 6m post bleeding stroke.~   "
13592|NCT03388957|"~     Evaluating anxiety, behavior, sedation and vital signs during dental extraction after orally~     taking either propranolol, midazolam, a combination of both or placebo in 6-9 years old~     uncooperative patients.~   "
13593|NCT03388944|"~     The investigators' objective is to compare the risk of mortality and/or treatment failure in~     children admitted to the PICU with sepsis and managed by PCT guided therapy for stopping of~     antibiotics ('study' group) with those managed with 'standard practices' based on the~     evidence based guidelines ('control' group). Children with suspected or proven sepsis will be~     randomized to the PCT guided group or the standard practices group and will be followed up~     for the outcome measures that include treatment failure and mortality. The investigators plan~     to enroll 650 patients over a period of 3 years. The investigators believe that the proposed~     study will provide the answer to reducing unnecessary antibiotic usage in the PICU without~     causing any harm to the patient in the form of treatment failure and/or mortality.~   "
13594|NCT03388931|"~     This is a phase 2 single arm study of a novel schedule of hyperfractionated radiotherapy (RT)~     in combination with our standard chemotherapy program for patients with stage 3-4 squamous~     cell carcinoma of the larynx. The primary hypothesis of our study is that the study program~     will improve Laryngectomy-Free Survival compared to historical controls. The study is limited~     to patients who would be receiving primary RT-C as standard therapy off-study.~   "
13595|NCT03388918|"~     The idea behind the Future Patient research project is to develop a telerehabilitation~     program and tools for patients with heart failure.~      The hypothesis for this study is that participation in a telerehabilitation program for~     patients with heart failure will increase the patients' quality of life and multi‐parametric~     (subjective and objective) individualized monitoring in a telerehabilitation program for~     patients with heart failure will increase detection of worsening of symptoms and avoid future~     hospitalization of the HF-patients.~   "
13596|NCT03388905|"~     The purpose of this current study is to prospectively enroll consecutive patients~     hospitalized with newly diagnosed severe left ventricular dysfunction (LVEF ≤ 35%) for which~     the likely etiology is uncontrolled atrial fibrillation or high burden of ventricular ectopy.~     Patients completing their established in-hospital treatment plan with rate or rhythm control,~     will be discharged with a WCD following informed consent and detailed counseling by~     healthcare personnel for a time-period of up to 3 months until reassessment of LVEF and the~     need for ICD implantation.~   "
13597|NCT03388892|"~     The investigators' study aims is to evaluate the safety and efficacy of percutaneous~     transluminal angioplasty (PTA) with paclitaxel-coated balloon (PCB) at venous anastomotic~     stenosis of arteriovenous graft (AVG) in patients with hemodialysis~   "
13598|NCT03388879|"~     This is a randomised, bi-centre, prospective, clinical trial in patients with closed tibia~     shaft fractures. The fracture should be fresh/acute and seen within 3 weeks after the injury.~     Patients will be randomised to surgery with either a Taylor Spatial Frame (Smith & Nephew,~     England) or a reamed intramedullar nail (according to local choice) with locking screws.~     Primary outcome measure is the physical component summary (PCS) of RAND Short form 36 (SF-36)~     after 2 years. Among secondary outcomes: Visual Analogue Scale (VAS) for pain, complications,~     healing, malunion, and resource use.~   "
13599|NCT03388866|"~     Atopic dermatitis (AD) is a chronic and recurrent inflammatory disease, prevalent between 1~     and 20% in the world population, with a predominance of childhood, but which may be present~     in adult life. AD results from a complex interaction between genetic and environmental~     factors, with the presence of a defect in the skin barrier and deregulation of the immune~     response, culminating in an inflammatory response in the skin predominantly type 2. Disease~     control is based on restoring skin hydration, smoothing itching and controlling the process~     specific sensitizing agents such as inhalant allergens and foods that may pathogenesis of the~     disease. In selected patients who present IgE mediated response to inhalant allergens,~     allergen-specific immunotherapy can be effective. Classically, the subcutaneous route is the~     most used, however, sublingual immunotherapy (SLIT) has been used in increasing form. There~     are still few studies on the efficacy and safety of SLIT in atopic dermatitis. Therefore, the~     present study aims to to investigate the role of SLIT in the management of patients with AD~     allergic mites, through a randomized, double-blind and placebo-controlled study~   "
13600|NCT03388853|"~     The objective is to assess efficacy and safety of Acetylcysteine/Doxofylline 1200/400 mg~     Effervescent Tablet once daily treatment besides standard/usual treatment, as compared with~     placebo once daily in patients with stable moderate to severe COPD.~   "
13601|NCT03388840|"~     Androgenetic alopecia is the most common type of alopecia in both men and women. About 80 %~     of Caucasian men and 40-50 % of Caucasian women are affected by androgenetic alopecia. The~     psychological impact of hair loss due to Androgenetic alopecia can be profound.~   "
13602|NCT03388827|"~     Laminaria and Misoprostol before Operative Hysteroscopy~   "
13603|NCT03388814|"~     Surgical treatment of breast cancer is associated with significant disability, and pain is~     often reported as a primary cause for declines in the ability to perform activities of daily~     living. However, breast reconstruction at the same time as mastectomy has been linked to~     higher postoperative pain, which can be a risk factor for persistent pain. The goal of this~     study is to determine the speed of recovery from pain and opioid use in the first 2 months~     after breast surgery and reconstruction.~   "
13604|NCT03388801|"~     The aim of the study was to evaluate the short- and long-term effects of spa therapy on~     quality of life and pain in patients aged 65 years and older with osteoarthritis.~      70 patients with osteoarthritis referred to spa treatment in south-eastern Poland were~     enrolled in the study. Spa treatment lasted 3 weeks.~      All the patients benefited from spa therapy.~      VAS pain scale, the Laitinen scale and WHOQOL-BREF questionnaire were used to assess the~     condition of the patients. The examinations were performed three times: at the beginning of~     the spa treatment, after three months and one year after the first examinations.~   "
13605|NCT03388788|"~     A multidisciplinary investigation examining the circadian mechanisms regulating~     cardiovascular risk in obesity. Specifically, in a valid circadian protocol, the~     investigators aim to study resting cardiovascular risk markers and the reactivity of~     circadian rhythms in these risk markers to standardized stressors in obesity. Furthermore,~     using an ingenious approach, the investigators propose to explore impairment in pre/post~     synaptic function in the cardiac left ventricle.~   "
14711|NCT03374371|"~     The purpose of the study is to identify biomarkers allowing the distinction between invasive~     and non-invasive strains of Staphylococcus epidermidis. This distinction is important to~     determine if the patient is infected and, as a consequence, if an antibiotic treatment is~     required.~   "
13606|NCT03388775|"~     Background: Deep venous thrombosis (DVT) is a common and important vascular disease due to~     its morbidity and mortality.~      Its incidence remains high throughout the world and constitutes serious problems for national~     and international public health.~      Several inherited and/or acquired risk factors may be responsible for thrombus formation. Few~     epidemiological data regarding real world panorama of this disease in South America and~     Brazil is available in the literature.~      Objective: Evaluate demographic data, diagnostic methods and treatment of deep vein~     thrombosis in the real world in public university hospitals in Brazil.~      Methods: Five-year prospective records of deep venous thrombosis have been collected by the~     RHEUNI group of five public schools in the State of São Paulo.~      Demographic data of patients will be evaluated along with the main risk factors, clinical~     picture, diagnostic methods, use of different drugs to treat the disease and its~     complications. Digital platform has been used in data collection. Is a multicenter study and~     analysis will be performed using Microsoft Excel and Epi-Info.~      Key words: deep vein thrombosis, assessment, risk factors, demographic data.~   "
13607|NCT03388762|"~     The primary purpose of this study is to evaluate the impact of a polyherbal dietary~     supplement (Designs for Health - GlucoSupreme™ Herbal) on markers of glycemic control and~     other structure/function outcomes among a sample of prediabetic adults.~      A 12-week randomized, double-blinded, placebo-controlled clinical trial will be conducted to~     achieve the purpose of this study. The research team hypothesizes that GlucoSupreme™ Herbal~     will improve a variety of validated markers of glycemic control that are commonly used in~     clinical practice more effectively than placebo.~   "
13608|NCT03388749|"~     This is a multi-center, open-label, dose escalation study that will determine the maximum~     tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of liposomal annamycin as a single~     agent for the treatment of subjects with AML that is refractory to or relapsed after standard~     induction therapy~   "
13609|NCT03388736|"~     The aim of this study is to determine the possible reducing effects of different~     concentrations of lavender oil on preoperative anxiety in orthognathic surgery patients who~     have high anxiety during preoperative wait.~   "
13610|NCT03388723|"~     India is one of the diabetes capitals in the world. Indians are susceptible to develop~     diabetes at a younger age and at a lower BMI compared to Europeans. Current prevention~     strategies focus on reducing risk in those with the established disease or risk factors. The~     Developmental Origins of Health and Disease (DOHaD) hypothesis suggests that chronic~     non-communicable diseases (NCDs) are programmed by disturbances in maternal and fetal~     undernutrition. This offers an alternative primordial prevention strategy to reduce NCDs in~     future generations by improving health and nutrition of young women. Previous work in the~     Diabetes Unit, KEM Hospital, Pune has described the role of maternal micronutrients affecting~     1-Carbon metabolism in the fetal programming of diabesity. In this application, the~     investigators offer to study other pathways of fetal programming i.e. maternal hyperglycemia~     and gestational diabetes mellitus (GDM) using an 'OMICs' approach. It is believed that~     epigenetic changes may be the main driver of programming. The investigators hypothesize that~     offspring of diabetic mothers will have different epigenetic signatures in cord blood and~     placenta compared to offspring of non-diabetic mothers. The investigators propose to study~     the effect of gestational hyperglycemia on newborn epigenetic signatures using the most~     appropriate technologies available and associate them with the underlying genotype. This will~     be performed on cord blood of 150 offspring of women with GDM and compared with a similar~     number of offspring of non-diabetic mothers recruited at Pune. The differentially methylated~     regions (DMRs) identified will then be validated by pyrosequencing in ~300 stored GDM cord~     blood samples in Pune. The investigators from Pune will also validate these markers in 200~     newly recruited offspring of GDM and 200 controls from a different cohort in Punjab which has~     a different diet and lifestyle. The DMRs will also be validated in placental samples from~     both Pune and Punjab. The investigators will further test the stability of these markers and~     their associations with phenotype in a follow-up study of offspring of GDM mothers in upto~     500 individuals. The investigators will compare the findings with the DNBC-GDM cohort in~     Denmark, allowing for differences in age, genetic make up, nutritional status and lifestyle.~     This study will help understand contribution of maternal diabetes to the current epidemic of~     diabesity and its molecular basis.~   "
13611|NCT03388710|"~     To verify the exact location of cuff of the endotracheal tube in children.~   "
13612|NCT03388697|"~     This will be a validation study of Quantose IR and Quantose IGT to predict insulin resistance~     and identify patients with prediabetes. This is a pilot study of 100 subjects. Based on the~     results of this initial trial, investigators plan to perform a larger trial at UTMB.~      Quantose IR is a fasting blood test for insulin resistance and prediabetes, and is clinically~     validated in non-pregnant individuals. The Quantose IR Score is based on three novel~     nonglycemic biomarkers, as well as insulin, and provides a comprehensive measure of insulin~     resistance. These analytes include:~        -  α-HB (α-hydroxybutyrate): positively correlated with insulin resistance and indicative~          of early β-cell dysfunction.~        -  L-GPC (linoleoyl-glycerophosphocholine): negatively correlated with insulin resistance~          and impaired glucose tolerance.~        -  Oleic Acid: positively correlated with increasing lipolysis and insulin resistance.~        -  Insulin: increased insulin is characteristic of insulin resistance and is an independent~          risk factor for type 2 diabetes and cardiovascular disease.~      Quantose IGT is designed to estimate the risk of being IGT. It is calculated from a multiple~     logistic regression model based on the fasting plasma levels of:~        -  Glucose.~        -  α−HB.~        -  β−HB.~        -  4-methyl-2-oxopentanoic acid.~        -  LGPC.~        -  Oleic acid.~        -  Serine.~        -  Vitamin B5. Participants in the study will be consenting to data collection and two~          visits for lab draw. The investigators will then evaluate the performance of the~          Quantose IR and Quantose IGT in the study population.~   "
13613|NCT03388684|"~     The present study aims to report our experience in conjoined twin separation surgery in~     Assuit university and pediatric hospital, Assiut university, Assiut, Egypt over a period of~     20 years.~   "
13614|NCT03388671|"~     The aim of this study will be to investigate the safety and analgesic efficacy of Transversus~     Abdominis Plane (TAB) Block versus psoas block blockade. Both blocks will be administered~     surgically and guided by the laparoscopy screen in children undergoing laparoscopic surgery.~   "
13615|NCT03388658|"~     The aim of this study was to assess the long-term success rates of pulmonary vein isolation~     using first and second generation cryoballoons in patients with paroxysmal and persistent~     atrial fibrillation.~   "
13622|NCT03388567|"~     Preventable failures in the drug chain are related to Drugs Problems Related Use and are~     associated with medication errors (prescription, dispensing, administration or use by the~     patient or caregiver), including failures In the Medication Supply System (availability and~     quality).~      The controlled drugs are those that contain substances regulated by international conventions~     on drug control. They are important in various fields of medicine, such as pain management,~     obstetric emergencies, mental disorders such as the treatment of substance dependence,~     psychiatry and neurology. It has been defined as abuse of drugs the improper use of these for~     non-medical purposes, and associated with the use without medical prescription, which can~     produce addiction or psychic or physical dependence.~   "
13616|NCT03388645|"~     Background:~      One of the main causes of respiratory infections in children and adults is RSV. This stands~     for respiratory syncytial virus. Healthy adults usually get a cold when they get an infection~     with RSV. They generally recover without any problems. But some infections can be~     life-threatening. Researchers want to study RSV infection in a safe, controlled setting in~     healthy adults to help develop new treatments.~      Objective:~      To test the safety of a higher dose of RSV A2 by spraying the virus into the nose, and~     studying how the body responds.~      Eligibility:~      Healthy adults ages 18-50~      Design:~      Participants will be screened during 2 screening visits with:~        -  Medical interview~        -  Physical exam~        -  Blood and nasal samples~        -  Chest X-ray (chest radiograph)~        -  Participants will have a heart test. Sticky patches on the body will detect heart~          electrical activity.~        -  Pulmonary function test (PFT). They will blow into a machine to measure airflow.~        -  Urine tests for pregnancy or drug use.~      Participants will be admitted to the hospital before they get RSV A2.~      Participants will get a single dose of RSV A2 as two sprays, one into each nostril.~      Participants will stay in the hospital under isolation for as long as it takes the body to~     clear RSV A2 from nasal fluids. This can take as long as 14 days or more.~      Participants cannot take any cold medicine to try to feel better.~      Every day, participants will:~        -  Answer questions about their symptoms~        -  Have nasal washes and/or nasal swabs collected~        -  Have a quick physical exam~      Participants will have blood drawn most days.~      After discharge, participants will keep a health diary.~      Participants will have 2 follow-up visits over 2 months. They will repeat most of the~     screening procedures.~   "
13617|NCT03388632|"~     Background:~      The drug IL-15 activates the immune system. The drugs nivolumab and ipilimumab unblock immune~     cells. The drugs together may allow immune cells to recognize and attack cancer cells,~     causing tumors to shrink.~      Objective:~      To test the effects and maximum dose of IL-15, nivolumab, and ipilimumab.~      Eligibility:~      People ages 18 and older who have cancer that does not respond to treatment~      Design:~      Participants will be screened with:~        -  Medical history~        -  Physical exam~        -  Heart, blood, and urine tests~        -  Scans~      Tumor biopsy: A small needle removes a tumor sample.~      Participants will be in 1 of 3 treatment groups:~        -  IL-15 with nivolumab~        -  IL-15 with ipilimumab~        -  IL-15 with nivolumab and ipilimumab~      Participants will take the drugs in four 6-week cycles. IL-15 is injected under the skin. The~     other two drugs are injected into an arm vein over 60-90 minutes. Participants may need to~     stay at the hospital 2-3 hours after the first dose of any drug to watch for side effects.~      Each cycle will include:~        -  Weekly blood and urine tests~        -  5 IL-15 injections~        -  1 ipilimumab injection if applicable~        -  3 nivolumab injections if applicable~        -  Scans and a tumor biopsy on day 42~      After cycle 4, participants will stop taking IL-15. They will continue the other drugs until~     they can no longer tolerate the side effects or their cancer gets worse. Those cycles will~     include:~        -  Blood tests on 3-4 days~        -  Urine tests on 1 day~        -  1 ipilimumab injection if applicable~        -  3 nivolumab injections if applicable~        -  Scans every other cycle~      After participants stop treatment, their doctor will monitor their side effects for 4 months~     or until they go away.~   "
13618|NCT03388619|"~     Background:~      Sometimes prostate cancer comes back after a person s prostate is removed. In this case,~     radiation is a common treatment. Radiation kills prostate cancer cells. It can be very~     effective. It is usually given in short doses almost every day for 6 or 7 weeks. Researchers~     want to see if a shorter schedule can be as effective. They want to see if that causes the~     same or fewer side effects. Usually, radiation is used to treat the entire area where the~     prostate was before surgery. In some patients, an area of tumor can be seen on scans.~     Researchers are also trying to see if they can give less dose to the area usually treated~     with radiation if the full dose is given to the tumor seen on scans.~      Objective:~      To find the shortest radiation schedule that people can tolerate without strong side effects.~      Eligibility:~      People at least 18 years old who have had a prostatectomy and will get radiation~      Design:~      Participants will be screened with:~        -  Medical history~        -  Physical exam~        -  Blood and urine tests~        -  Scan that uses a small amount of radiation to make a picture of the body~        -  Scan that uses a magnetic field to make an image of the body~        -  Participants will provide documents that confirm their diagnosis.~        -  Participants may have a scan of the abdomen and pelvis.~      Before they start treatment, participants will have another physical exam and blood tests.~      Participants will get radiation each day Monday through Friday. Treatment may last 2, 3, or 4~     weeks.~      Participants may provide a tissue sample from a previous procedure for research.~      Participants will answer questions about their general well-being and function.~      About 4-5 weeks after they finish radiation treatment, participants will have a follow-up~     visit. They will be examined and give a blood sample. They will have 6 follow-up visits for~     the next 2 years.~   "
13619|NCT03388606|"~     Background:~      Almost 20% of Americans have depression. It is a leading cause of disability because it is~     chronic and it starts early. The highest incidence is among adolescents and young adults. But~     researchers don t know much about how depression occurs. It may be linked to reward~     processing.~      Objective:~      To characterize and treat depression in youth by focusing on reward processing.~      Eligibility:~      People ages 11-17 with major depressive disorder or subthreshold depression~      Healthy volunteers ages 11-17~      Design:~      Participants will be screened with interviews and questionnaires. They will have memory,~     thinking, and concentration tests. They may have a urine pregnancy test or have photos or~     videos taken.~      At the initial visit, participants will:~        -  Repeat screening tests~        -  Watch an interactive video about mood problems and anxiety~        -  Have functional MRI. Participants will lie in a metal cylinder in a magnetic field. They~          will do study tasks on a screen.~        -  Look at pictures to evoke happiness, sadness, or fear and get money for making certain~          choices. Parents can check the pictures before the children see them.~        -  Have brain and eye activity monitored~        -  Do tasks in a virtual reality environment~        -  Wear an activity monitor~      Participants will get phone prompts at home to ask about their mood.~      Participants will have several follow-up visits the first year, then 1 a year until they are~     25. They will repeat some tests above.~      Some participants with depression will have more visits before and after they have treatment.~     They will do some of the tests above plus drug testing. Participants and their parents will~     talk with a nurse, social worker, or psychologist. They will have practice work between~     visits.~   "
13620|NCT03388593|"~     The purpose of this study is to evaluate efficacy of rhNRG-1 in reducing the death rate of~     heart failure subjects with baseline NT-proBNP level <1600 pg/mL and NYHA class II to III.~   "
13621|NCT03388580|"~     Bronchoalveolar lavage (BAL) is an important diagnostic method. The percentage of fluid~     extracted after instillation (recovery rate) is crucial for following diagnostic tests. The~     investigators aimed to compare novel quantified airway parameters from pre-interventional~     lung computed tomography (CT) with recovery rates to find possible predictive markers.~   "
13623|NCT03388554|"~     The study aimed to investigate whether transcranial direct current stimulation could modify~     auditory hallucination, insight, neurocognitive function, heart rate variability,~     psychosocial functioning and quality of life in patients with schizophrenia.~   "
14073|NCT03382678|"~     The purpose of this study is to validate the online cohort of EGID patients enrolled in the~     RDCRN CEGIR CR. In order to achieve this objective, the investigators will determine the~     agreement between self-reported EGID information by the enrollees and their physician's~     report and medical records. All participants enrolled in the RDCRN CEGIR CR with EGIDs will~     be invited via email to participate in this study.~   "
13624|NCT03388541|"~     Delirium after cardiac surgery can occur in up to 50% of the patients and has been shown to~     be significantly associated with increased morbidity and mortality. Advanced age is a~     significant risk factor of delirium.~      Numerous studies have shown that sedation with high doses of Dexmedetomidine in the ICU~     reduces the incidence of postoperative delirium. On the other hand animal studies have shown~     neuroprotective effects of Dexmedetomidine by means of stimulating alpha2A-adrenoceptors.~      It is not clear whether the administration of a low dose Dexmedetomidine in cardiac surgery~     would have any neuroprotective effects by stimulating the alpha 2A-receptors and as such~     would decrease the incidence of postoperative delirium.~   "
13625|NCT03388528|"~     Slow movement of patients guts is referred to as intestinal dysmotility, and is increasingly~     recognised as a debilitating manifestation of mitochondrial disease both in adults and~     children.~      To date, symptoms of slow gut movements have been managed with laxatives and drugs that~     increase movement of the guts with variable results. A low residue diet is a form of low~     fibre diet (<10g fibre per day) that is used to minimise symptoms of poor movement of the~     guts. This reduces fecal volume and bulk, and hence gut workload, ensuring limited bowel~     activity and colonic rest. It has been shown to be well accepted in other conditions~     associated with slow gut movements. However, its role in patients with mitochondrial disease~     is unknown. The investigators are particularly interested in:~        -  Does a low residue diet (low fibre) cause a change in the number of stools per week and~          stool consistency?~        -  Is a low residue diet tolerated well and easy to comply with?~        -  Does a low residue diet reduce gut symptoms of abdominal pain, bloating, and~          constipation?~        -  Does a low residue diet improve quality of life and disease burden?~        -  Does a low residue diet affect the bacteria in the gut?~        -  Can we prove by X-ray that movement of food through the gut is slowed in patients with~          mitochondrial disease, and whether a low residue diet alters the speed of movement of~          food through the gut?~        -  Can a low residue diet change patients physical activity levels?~        -  Does a low reside diet change dietary patterns and food intake?~        -  Does a low residue diet alter anthropometrics, such as weight, body mass index and waist~          to hit ratio?~        -  Can a low residue diet improve kidney and liver function and lipid profile in blood~          samples?~      The investigators hope that by looking at these areas that a low residue diet may be able to~     improve patients slow gut movements, health, quality of life and disease burden.~   "
13626|NCT03388515|"~     SSS11 is pegsiticase consisting of a recombinant uricase conjugated to multiple 20kDa PEG~     molecules. The purpose of this study is to assess the safety, tolerability, pharmacokinetics~     and pharmacodynamics of single dose SSS11 administered intravenously in healthy volunteers.~   "
13627|NCT03388502|"~     This study evaluates the addition of an automated physician-specific text-messaging (SMS) bot~     in patients undergoing total joint arthroplasty. Half of the patients received the~     traditional perioperative education and instructions (control group), while the other half~     were enrolled in their physician's SMS bot (intervention group).~   "
13628|NCT03388489|"~     Mind-body exercise improves symptom of negative moods, dyspnea and quality of life in chronic~     diseases, but these improvements for chronic obstructive pulmonary disease (COPD) are~     unproven. This study aims to examine the effects of dyspnea, exercise capacity, heart rate~     variability(HRV), anxiety, depression, interoceptive awareness, quality of life(QoL) in~     patients with COPD across a three-month mind-body exercise program.~   "
13629|NCT03388476|"~     Measurement of the endtidal carbon dioxide by capnography to exclude or to ensure the~     diagnosis pulmonary hypertension. The aim of the study is to obtain an endtidal carbon~     dioxide cut-off value for the diagnostic algorithm for pulmonary hypertension as an easily~     measurable and cheap diagnostic tool in patients with suspicion of pulmonary hypertension.~   "
13630|NCT03388463|"~     Upper gastrointestinal (GIT) bleeding is common in high risk critically ill patients.~     Hyperacidity has been identified as one of the main reasons for bleeding.1 2 Antacids with~     different treatment modalities have been studied to establish the best regimen for~     prophylaxis against bleeding.3 4 Proton pump inhibitors (PPI) are the most common drugs used~     in the medical field as antacids. The present study was carried out to investigate the~     beneficial effects of high dose omeprazole versus standard low dose as a prophylaxis against~     upper GIT bleeding in high risk critically ill patients.~   "
13631|NCT03388450|"~     Sepsis is the most common reason for intensive care unit (ICU) admission. Sepsis flares up~     the systemic inflammatory response with its mediators. Sepsis treatment protocols have been~     established in many centres with immune nutrient as adjuvant treatment. Omega-3 fatty acid~     and other anti-oxidants formulae have been found to improve sepsis outcome. In most of the~     studies, immune nutrients were giving parenterally, however, nowadays the preferable route of~     feeding in critically ill patients is enterally. The present study was done to investigate~     the effect of enteral Omega-3 fatty acid in septic critically ill patients.~   "
13632|NCT03388437|"~     Non-invasive respiratory support has been emerging in the management of respiratory distress~     syndrome (RDS) in preterm infants to minimise the risk of lung injury. Intermittent positive~     pressure ventilation (NIPPV) provides a method of augmenting continuous positive airway~     pressure (CPAP) by delivering ventilator breaths via nasal prongs.It may increase tidal~     volume, improve gas exchange and reduce work of breathing. However, NIPPV may associate with~     patient-ventilator asynchrony that can cause poor tolerance and risk of intubation. It may~     also in increased risk of pneumothorax and bowel perforation because of increase in~     intrathoracic pressure.~      On the other hand, neurally adjusted ventilatory assist (NAVA) is a newer mode of~     ventilation, which has the potential to overcome these challenges. It uses the electrical~     activity of the diaphragm (EAdi) as a signal to synchronise the mechanical ventilatory~     breaths and deliver an inspiratory pressure based on this electrical activity. Comparing~     NI-NAVA and NIPPV in preterm infants, has shown that NI-NAVA improved the synchronization~     between patient and ventilator and decreased diaphragm work of breathing .~      There is lack of data on the use of NI-NAVA in neonates post extubation in the literature. To~     date, no study has focused on short-term impacts. Therefore, it is important to evaluate the~     need of additional ventilatory support post extubation of NI-NAVA and NIPPV and also the risk~     of developing adverse outcomes.~      Aim:~      The aim is to compare NI-NAVA & NIPPV in terms of extubation failure in infants< 32 weeks~     gestation.~      Hypothesis:~      Investigators hypothesized that infants born prematurely < 32 weeks gestation who extubated~     to NI-NAVA have a lower risk of extubation failure and need of additional ventilatory~     support.~   "
13633|NCT03388424|"~     Microbiota consists of trillions of microorganisms located in all the biological cavity. The~     relationships between individual health status and microbiota are based on a sort of mutual~     cooperation. The balance of the microbiota can be compromised by various factors such as~     environmental, psycho-physical stress, malnutrition (over or low), breastfeeding, chronic~     diseases, oncology and pharmacological treatments (especially antibiotics and~     chemotherapics). The impact of dysbiosis on today's society affects over 70% of the world~     population~   "
13672|NCT03387904|"~     To compare the effects and safety of Anlotinib Plus Irinotecan versus Irinotecan in patients~     with esophageal squamous cell carcinoma(ESCC).~   "
13634|NCT03388411|"~     Pediatric obesity has been increasing in prevalence, but concerns have been raised around the~     world because no treatment has been found. Recently, however, research on gut microbiome has~     begun to become a new alternative. It has been shown that changes in the microbiome in adults~     may induce obesity. However, the results on children are still scarce. Unlike adults,~     children have few external factors such as alcohol, tobacco, stress, and cancer, making them~     suitable for obesity-related gut microbiome studies. The investigators will use Illumina~     MiSeq platform for 16s rRNA metagenomics profiling in children. In this study, the~     investigators aimed to analyze the relationship between pediatric obesity, gut microbiome~     profile, blood biomarkers relevant to metabolic syndrome, and nutrient intake data.~   "
13635|NCT03388398|"~     This study evaluates the impact of Zimbabwe's program for the prevention of mother-to-child~     HIV transmission (PMTCT) on vertical transmission of HIV infection and HIV-free survival~     among infants exposed to HIV. The study will test the hypothesis that the accelerated PMTCT~     program in Zimbabwe will result in fewer new HIV infections in infants and will increase~     infant survival.~   "
13636|NCT03388385|"~     The purpose of this study is to investigate the effects of acute intravenous iron~     administration on the endothelial function in non-dialysis Chronic Kidney Disease stages~     G3-G5 patients with anemia and iron deficiency, in relation to changes in oxidative and~     nitrosative status.~   "
13637|NCT03388372|"~     This study aimed to investigate the clinical benefit contribution and safety of nimotuzumab~     to the standard combined treatment for patients with newly diagnosed glioblastoma.~   "
13638|NCT03388359|"~     Asthma is a major noncommunicable chronic inflammatory disorder which is characterized by~     airway inflammation and related to pathological modifications of the bronchial wall structure~     so called airway remodeling. Airway remodeling seen in asthma is mainly described by~     epithelial changes, subepithelial fibrosis, increased airway smooth muscle (ASM) mass,~     decreased distance between ASM and epithelium, mucous gland and goblet cell hyperplasia,~     vascular changes and edema. Near these well known pathophysiological changes of the airways,~     the extracellular matrix (ECM) can be distinguished as a new important factor included in~     development of airway remodeling in asthma.~   "
13639|NCT03388346|"~     This study investigates if a new drug (PSMA) makes prostate cancer easier to identify in~     positron-emission tomography (PET) imaging. If this works, prostate cancer treatments can be~     prescribed that match the location of the disease. PSMA is radiolabeled with Gallium-68~     (Ga-68). This means a participant receives a small dose of radiation from the drug - less~     than the annual radiation limit for a medical worker.~      To test this new drug, participants will receive an injection of Ga-68 PSMA and then have a~     PET scan. This PET scan, and the reported results, will be entered into the medical record~     and shared with the treating oncologists.~   "
13640|NCT03388333|"~     The investigators aim to find biomarkers to determine the success of pulmonary vein isolation~     for the treatment of atrial fibrillation.~   "
13641|NCT03388320|"~     This is a pilot study examining whether an evidence-based recovery support smartphone~     application, the Addiction Comprehensive Health Enhancement Support System (A-CHESS), can~     decrease alcohol recidivism in a previously unstudied group of patients with alcoholic liver~     disease (ALD).~   "
13642|NCT03388307|"~     The purpose of this study was to compare standard open laminectomy with ULBD approach in~     regard to efficiency, safety, and clinical outcome.~   "
13643|NCT03388294|"~     This study entails a proof of concept evaluation of a novel intervention, Parents and~     Infants Engaged (PIE), for prodromal infants at-risk for neurodevelopmental disorders (NDs).~     The objectives of the current study are to examine whether the PIE intervention (a)~     transforms parent-infant transactions over time as intended, thereby facilitating increases~     in the time infants spend in joint engagement with their parents, and (b) is associated with~     improved social-communication functioning and positive changes in indices of autonomic~     self-regulation in infants at-risk for NDs.~   "
13644|NCT03388281|"~     Previous publications suggest gender difference in outcome parameters after pacemaker~     implantation. Aim of this study is to investigate gender differences in patients with~     pacemaker. Implanted devices, indication for implantation and pacemaker follow up data of~     patients will be included. Survival data including cause of death will be documented.~     Prevalent comorbidities and relevant laboratory data will be recorded.~   "
13645|NCT03388268|"~     The purpose of this study is to determine the risks and benefits of antibiotic treatment for~     Clostridium difficile infection (CDI) among patients whose stool samples are nucleic acid~     amplification test (NAAT) positive and enzyme immunoassay (EIA) negative for C. difficile.~      Currently, healthcare facilities use a wide variety of tests and strategies for identifying~     patients with CDI; both EIA and NAAT are widely used. There is no clear gold standard for~     identifying CDI. At WUSM and BJH, patients are only treated for CDI if they have a positive~     EIA. However, at many other healthcare facilities, the standard of care is to treat for CDI~     if the patient is NAAT positive. Some patients who are NAAT-positive may not have true CDI;~     while this treatment is standard of care at many facilities, the risk and benefits of~     treating these patients for CDI is unknown.~      We propose to perform a double blinded, randomized controlled non-inferiority trial of~     antimicrobial of patients who are EIA negative, NAAT positive to determine the risks and~     benefits of CDI treatment in this population.~   "
13646|NCT03388255|"~     This is a phase IV, single-arm, open-label clinical trial to evaluate the efficacy and safety~     of PLACENTEX ® Polydeoxyribonucleotide i.m. in patients with fibrotic and atrophic cutaneous~     lesions in scleroderma diseases during the inactive stage of the disease (experiencing~     dystrophic outcomes of the disease with no inflammatory component at the time of enrolment).~      The patients enrolled will be evaluated at study site at screening (V1), then after 3 months~     of treatment with PLACENTEX ® Polydeoxyribonucleotide (one vial per day for intra-muscular~     administration) (V2). After completion of the study treatment period, the patients will be~     followed for an additional period of 3 months without study medication, after which the~     patient will visit the site for the last visit (V3). 1 investigational site. 45 patients~     enrolled (included drop-outs).3 months of treatment with PLACENTEX ® Polydeoxyribonucleotide~     (one vial per day for intra-muscular administration).~   "
13673|NCT03387891|"~     Clinical data validation of the C3 device as a Vital Sign Monitoring System for patients~     under cancer treatment.~   "
13674|NCT03387878|"~     To evaluate the performance of GentleCath Glide™ Intermittent Catheters~   "
13647|NCT03388242|"~     Blood will be harvested from three groups of people, normal control, patients with mild~     cognitive impairment (MCI) and patients with Alzheimer's disease (AD), 20 people per group.~     The blood samples will be used to determine the difference in the expression of microRNAs and~     proteins. Blood samples will be harvested again at 6-month interval from patients. The~     combination of the microRNAs and proteins that have different expression patterns between~     normal control and patients with MCI will be constructed in a kit to detect the difference.~     This kit will be used in another set of the three groups of people to determine its~     sensitivity and specificity in detecting patients with MCI.~   "
13648|NCT03388229|"~     Poor glycemic control in patients with Type 2 Diabetes (T2D) is due to multiple factors and~     suboptimal dietary pattern is one of them .Assessing eating/dietary patterns (combinations of~     different foods or food groups) among individuals with diabetes may be beneficial in~     understanding the focus areas of dietary modification among the Emirati community and further~     developing dietary interventions for management of T2D. Only a few observational studies are~     reported in this region exploring the eating practices, although none to the investigators~     knowledge described the frequency of consumption of food groups in the T2D patients in the~     United Arab Emirates(UAE). Hence, in this study the investigators aim to describe the trends~     in frequency of consumption of food groups and analyze the association of frequency of food~     item consumption and glycemic control among the T2D UAE patients.~      This retrospective cross sectional study will include the data from Hospital information~     system of 800+ T2D patients to describe the trends in frequency of consumption of food groups~     and analyze the possible association of frequency of food group/item consumption and glycemic~     control.~   "
13649|NCT03388216|"~     This is Prospective Randomized Placebo controlled Single Blind Phase I study to evaluate the~     safety, tolerance and pharmacokinetics of the anti-Shiga toxin hyperimmune equine~     immunoglobulin F(ab')2 fragment (INM004) in healthy volunteers.~   "
13650|NCT03388203|"~     The present study assessed serum 25(OH)D in a cohort of 74235 outpatients by~     liquid-chromatography-tandem-mass-spectrometry (LC-MS/MS).~      The investigators studied the distribution of serum 25(OH)D concentrations in males and~     females of different age groups, the prevalence of measurable amounts of 25(OH)D2 and~     seasonal variability.~   "
13651|NCT03388190|"~     This study aims to determine the efficacy, safety, and tolerability of the sequential~     addition of immune-modulating therapy to standard-of-care therapy of microsatellite-stable~     (MSS) metastatic colorectal cancer (mCRC).~   "
13652|NCT03388177|"~     The investigators examine whether adding yoga-based therapy (YBT) to treatment as usual (TAU)~     for young adult women (age 18-34 years) with a primary diagnosis of MDD leads to (1) greater~     reductions in symptoms and (2) greater cost-effectiveness in that the economic benefits of~     adding YBT to TAU outweigh the costs.~   "
13653|NCT03388164|"~     This study aims to determine whether a combination a first-line antidepressant plus RT2CK17~     in a capsule relative to a first-line antidepressant plus placebo in a capsule results in~     higher rates of medication adherence in individuals with moderate to severe depression. In~     this double-blind randomized placebo controlled trial, 100 individuals with a Quick Inventory~     of Depressive Symptomatology-Self Report (QIDS-SR) scale score ≥ 14 will be enrolled to~     participate in an 8 week treatment study. Participants will be randomized with a 1-1 ratio to~     receive 5 milligrams (mg) RT2CK17 + 10 mg escitalopram or placebo + 10 mg escitalopram to~     be taken orally once per day. Participants will undergo a 3 hour baseline evaluation visit at~     week 0, two 30-minute office visits (week 2 and 4), one 60-minute office visit (week 8) and~     three 5-minute phone calls (weeks 1, 3, and 6) during which clinical assessments and measures~     will be obtained. The trial is designed with two stages: 20 participants in Stage 1 will be~     used to estimate the adherence effect size; Stage 2 is designed with an interim analysis to~     test our hypotheses.~   "
13654|NCT03388151|"~     propofol versus use of midazolam as sedative agent in patients with liver cirrhosis presented~     for lower gastrointestinal endoscopy~   "
13655|NCT03388125|"~     Endoscopic Injection Sclerotherapy vs N-butyl-2-cyanoacrylate Injection~   "
13656|NCT03388112|"~     The purpose of this study is to evaluate the effect of probiotics on the gut microbiome of~     infants treated with antibiotics.~   "
13657|NCT03388099|"~     Aim of study: To compare the relationship between serum AMH and ovarian response for IVF with~     the GnRH antagonist protocol in patients who are carriers of FSH and/or LH receptor~     polymorphisms with those that are not.~   "
13658|NCT03388086|"~     The changes in bladder function after the injection of Onabotulinum toxin into the detrusor~     in individuals with neurogenic bladder overactivity will be investigated retrospectively. The~     records of all patients treated with Onabotulinum toxin injections into the detrusor since~     2000 will be evaluated. The changes in the urodynamic values after the injection of 300 units~     of Onabotulinum toxin will be compared with the changes after the injection of 200 units.~     Furthermore, the differences in urinary continence, duration between injections, side effects~     and complications between the two groups will be investigated.~   "
13659|NCT03388073|"~     The purpose of this clinical study is to evaluate acute effects of plant-based nutritional~     extracts on adult stem cells, using a randomized double-blinded placebo-controlled cross-over~     study design.~   "
13660|NCT03388060|"~     compare the efficacy of of ultrasound guided SWL versus dissolution therapy versus combined~     SWL and dissolution therapy in management of 1 - 2.5 cm renal stones.~   "
13661|NCT03388047|"~     Multispectral imaging represents an exciting new field of investigation in endoscopic~     research. Multispectral imaging uses a specialised camera to detect multiple colours,~     allowing us to build a rough spectrum from each point in our image. It is widely reported~     that these spectra are different for different tissue types, but this is difficult to study~     ex vivo since de-oxygenation of the blood and decay of the tissue change these spectra~     considerably.~      The investigators have therefore designed this study to asses the different multispectral~     imaging spectra of Barrett's Oesophagus, which we believe might be utilised as a method to~     detect dysplasia in the future.~   "
13688|NCT03387696|"~     Mucormycosis is an invasive fungal infection affecting patients with various clinical~     conditions especially patients with heavy immunosuppression or patients with trauma or~     extensive burns.~      ZygoRéa is a retrospective and multicentric French study aimed to evaluate survival of~     patients with mucormycosis admitted in ICU at day-28 after admission. This study will also~     try also to describe the epidemiology of patients admitted in ICU.~   "
13662|NCT03388034|"~     Due to waning of infectious as well as vaccine immunity and lack of vaccination boosters, a~     large number of adolescents and adults are no longer immunized against Bordetella pertussis,~     the agent of whooping cough and consequently may contract whooping cough. Furthermore, these~     populations represent a reservoir of the infectious agent from which the dissemination to~     non-immune infants is possible, causing severe illness, or even death, in this age group.~      Few studies have been carried out on whooping cough in developing countries (incidence,~     contaminator's age, etc.) and, specifically, none have assessed the duration of protection~     induced by the whole cell pertussis (wP) vaccine mainly presently used in these countries.~      However, data on the duration of vaccine induced protection are essential to determine i) the~     usefulness of vaccine boosters and ii) the target age group for these boosters.~      The aims of the present study are:~        -  To evaluate the proportion of confirmed pertussis cases in infants presenting whooping~          cough syndrome (WP1a)~        -  To evaluate the proportion of confirmed pertussis cases or healthy carriers among~          contact cases~        -  To determine origin of the infant's contamination (WP1b)~        -  To determine the duration of protection induced by the wP vaccines used in contact cases~          and the child population aged 3 to 15 yo (WP1b and WP2)~        -  To bring new scientific evidences documenting the potential need for initiating boosters~          (WP1b and WP2)~        -  To allow a comparison of the results with those obtained using the same methodology for~          the acellular pertussis vaccine and/or in other contexts. Potential implications for the~          use of pertussis vaccines in low and moderate income countries.~        -  To increase local capabilities by the transfer of materials and expertise that will make~          the diagnosis of pertussis possible in the centres of reference and strengthen a~          pertussis monitoring network in the implicated countries.~        -  To improve children's health through a better match of the vaccination schedule~          according to the reality of the situation.~   "
13663|NCT03388021|"~     this randomized controlled trial will compare the impact of routine use of completion~     angiography versus using it on selective bases after thromboembolectomy in patients with~     acute lower limb ischemia and their impact on limb salvage rates~   "
13664|NCT03388008|"~     This is a pilot randomized controlled trial examining the feasibility of conducting a large~     scale randomized controlled trial of belatacept-based immunosuppression in lung~     transplantation. This pilot study will enroll 40 lung transplant recipients and randomize~     them to belatacept-based immunosuppression or standard of care. The primary endpoint of the~     study is the development of donor-specific HLA antibodies after transplantation. All study~     participants will be followed for a minimum of 12 months after transplantation.~   "
13665|NCT03387995|"~     Intracranial aneurysms (IA) regarded the third cause of cerebral vascular disease is the~     majoy cause of subarachnoid hemorrhage (SAH). The mortality and morbidity account for 22% to~     25% in cerebrovascular disease. More than half of the ruptured IA survivors has serious nerve~     dysfunction such as hemiplegia, aphasia,which seriously harms to human health. Endovascular~     embolization is one of the main treatment ways of IA.However,there are no studies on the~     multicenter cases of stent selection strategy at home and abroad.Therefore, the investigators~     conduct a prospective study by comparing the clinical efficacy, follow-up results, and~     hemodynamics between preoperative and postoperative patients with different types of stent~     assisted embolization treatment of IA.The investigators also study the relationship between~     cyclin dependent kinase inhibitor 2B antisense RNA 1 gene（CDKN2BAS1 gene）of IA patients and~     the results, for making indication of stents, improving the cure rate, reducing the~     recurrence rate of IA patients, providing theory gist for interventional therapy of complex~     IA and simplying slection of stent.~   "
13666|NCT03387982|"~     Barrett's esophagus is a condition in which the normal lining of the lower esophagus is~     replaced with cells that predispose an individual to development of esophageal cancer.~     Treatment of Barrett's esophagus reduces the risk of progression to cancer. Treatment is~     provided endoscopically, via a variety of approved techniques including endoscopic mucosal~     resection, argon plasma coagulation, radiofrequency ablation (RFA), spray cryotherapy~     ablation and balloon cryotherapy ablation. A common side effect of ablation treatment is~     pain, thus making pain an important factor when discussing treatment options. It is~     speculated that balloon cryotherapy causes less pain than RFA but no head-to-head comparison~     trials exist to date. This multi-center, prospective cohort study aims to compare pre- and~     post-procedural pain for balloon cryotherapy versus RFA. Providing both patients and~     clinicians with data from a well-designed prospective study may help guide future~     physician/patient treatment discussions.~   "
13667|NCT03387969|"~     Meningitis is one of the major lethal infectious diseases especially for the children in~     developing countries .It is not always possible and often very difficult to distinguish~     between bacterial and viral meningitis according to CSF findings, which is not accurate 100%~     and leads to unnecessary antibiotic usage , So We tried to find a useful 'bedside'~     decision-making tool, based on laboratory results readily available at the emergency~     department .~   "
13668|NCT03387956|"~     Patients undergoing abdominal surgeries,under general anesthesia have the risk of~     post-operative nausea and vomiting. A lot of modalities have been utilized to decrease this~     problem.. pharmacological ,and non pharmacological modalities are available.~   "
13669|NCT03387943|"~     This is a prospective, multicenter, open label Phase II Clinical Trial. 30 advanced poorly~     differentiated thyroid carcinoma patients who were histopathologically confirmed inoperable~     were enrolled in this study.~   "
13670|NCT03387930|"~     Low back pain (LBP) is a severe epidemic in the world. Despite its high prevalence, 90% of~     the cases have no identifiable cause. Approximately 44% of them experience recurrent LBP~     within one year and 10% of them develop chronic LBP that lasts for three months or more.~      Mechanically, the lumbar spine is unstable and requires spinal muscle to maintain spinal~     stability and to prevent injuries. Lumbar multifidus (LM) muscle is thought to be the major~     spinal stabilizer responsible for spinal stability and spinal proprioception. Prior studies~     have revealed that increased fat infiltration, atrophy or activation deficits of LM in~     patients with LBP as compared to asymptomatic individuals. Unfortunately, inconsistent~     findings have also been reported.~      Although prior research attempted to determine if abnormal LM characteristics can inform~     clinical decision-making, their results are limited because they only investigated a single~     LM characteristic at a time, which might not reflect the actual LM condition. Further, many~     studies adopted cross-sectional design that could not reveal the casual relations between~     abnormal LM characteristics and LBP. As such, the current study aims to identify specific LM~     characteristics that can predict new episode of LBP in asymptomatic individuals, and~     recurrent/chronic LBP in individuals with LBP at baseline.~   "
13671|NCT03387917|"~     TLD-1 is a novel liposomal formulation of doxorubicin (PEG surface) that compared favorably~     to conventional liposomal formulations of doxorubicin including Caelyx® in preclinical in~     vivo models. Particle features including size, charge distribution, lipid composition and~     drug release add up to a considerably altered particle behavior compared to Caelyx®,~     potentially explaining the lack of hand-foot-syndrome in respective animal models.~     Preclinical evaluation confirmed TLD-1 to be a promising new and innovative formulation of~     doxorubicin with promising activity and good tolerability.~   "
13675|NCT03387865|"~     This prospective, single-center, interventional study is conducted in order to achieve a~     biological bank accompanied by clinical data. Blood samples, optional tumor tissue and fecal~     samples are collected, processed and banked for all the included subjects. Those samples are~     collected before the start of treatment, at the time of first tumor assessment, at the time~     of first and second disease progression. The subjects are treated according to standard of~     care.~      Clinical data are collected at each sampling time. The primary objective of the study is to~     identify biological, clinical and tumoral factors associated with tumor response according~     SOC treatment.~   "
13676|NCT03387852|"~     Primary Objective:~      To evaluate the effects of SAR440340/REGN3500 with or without dupilumab, compared to placebo,~     on reducing the incidence of loss of asthma control (LOAC) events.~      Secondary Objectives:~      To evaluate the effects of SAR440340/REGN3500 and coadministration of SAR440340/REGN3500 and~     dupilumab, compared with placebo, on forced expiratory volume in 1 second (FEV1).~      To evaluate the effects of coadministration of SAR440340/REGN3500 and dupilumab, compared~     with SAR440340 and compared with dupilumab, on FEV1.~      To assess safety and tolerability of SAR440340/REGN3500 alone and in coadministration with~     dupilumab.~   "
13677|NCT03387839|"~     A retrospective one-time evaluation of total knee patients one year or more postoperative, to~     compare antero-posterior (AP) stability with the TELOS Stress device/stress x-rays and~     clinical outcomes. Multiple implant brand/models will be included in the study.~   "
13678|NCT03387826|"~     Taken together the results from DAPT and PEGASUS-TIMI54, it appears that physicians may~     consider extending beyond 1 year or reinitiating treatment with a thienopyridine or~     ticagrelor 60mg bid in patients with a prior MI and features of high ischemic and low~     bleeding risk. Comparative clinical or pharmacodynamic studies, however, between prasugrel 5~     mg od and ticagrelor 60 mg bid in the chronic phase of stable post MI patients have not been~     performed.~      In light of this, we believe that a dedicated pharmacodynamic study of ticagrelor 60 bid mg~     vs prasugrel 5 mg od in a PEGASUS-like population would be informative for the practicing~     clinician, thus setting the rationale for conducting this specifically designed~     investigation.~   "
13679|NCT03387813|"~     The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the~     CardioMEMS™ HF System in an expanded patient population including heart failure (HF) patients~     outside of the present indication, but at risk for future HF events or mortality.~   "
13680|NCT03387800|"~     The proposed RCT evaluates the efficacy of the aforementioned novel 2-month online smoking~     cessation intervention in increasing 7-day point prevalence quit rate over a 6-month~     follow-up period among Chinese adult smokers in Hong Kong.~   "
13681|NCT03387787|"~     The GlucoTab® system is a computerized decision support system built of an android based~     front-end user interface and a backend server including the REACTION algorithm. GlucoTab® is~     able to process blood glucose data and physiological confounders of glycaemia. Subsequently,~     GlucoTab® provides patient-specific basal, bolus, and correction insulin doses together with~     visualization and documentation of relevant data. The GlucoTab® system was found capable to~     keep hospitalized diabetic patients in the recommended target range without increasing the~     risk for hypoglycaemic events. Insulin pharmacokinetic is a critical confounder of glycaemic~     variability and the main determinant of an algorithm-based decision support-system. GlucoTab®~     is intended for being used with a basal/bolus insulin regimen. Up to date, feasibility data~     are limited to the use of insulin glargine.~      Insulin degludec, an ultra-long acting basal insulin is characterized by a stable~     pharmacokinetic profile a half-life of ~25 hours. It was found equally effective to insulin~     glargine with respect to glycaemic control, while the incidence of (nocturnal) hypoglycaemia~     was smaller in patients treated with insulin degludec. Within the present study, insulin~     glargine will be replaced by insulin degludec, which is not yet approved for dose titration~     with GlucoTab®.~      In the present study, 15 non-critically ill T2DM patients, who were hospitalized at the~     University Clinic of Neurosurgery for various reasons and require insulin treatment will be~     recruited. Patients will be treated with insulin Tresiba and insulin Novorapid. For a maximum~     duration of 21 days, GlucoTab® will calculate the required insulin doses for each patient,~     depending on fasting plasma glucose and postprandial glucose measurements during the day.~     After the calculated Insulin dose has been approved by the physician, the nursing staff will~     give the dose to the respective patient.~      The present study will analyse the efficacy of GlucoTab® for glycaemic management in T2DM~     patients using insulin degludec.~   "
13682|NCT03387774|"~     This is a phase 3, open-label, multicenter, randomized controlled phase III clinical trial.~     The purpose of this study is to evaluate the efficacy of ulinastatin, a kind of protease~     inhibitor, in the treatment of radiation-induced acute oral mucositis in localregionally~     advanced nasopharyngeal carcinoma(NPC) patients treated with concurrent~     chemoradiotherapy(CCRT). To Explore a new and efficient way to reduce the incidence and~     severity of radiation-induced acute oral mucositis.~   "
13683|NCT03387761|"~     In this single-arm trial we will investigate the safety of short-term preoperative therapy~     with ipilimumab and nivolumab in patients with high-risk resectable urothelial cancer. We~     will determine the number of patients that have surgical resection at <12 weeks, as this is~     an endpoint that is clinically meaningful for this population. 24 patients will be included.~     All patients will be receiving a sequenced scheme of Nivolumab and Ipilimumab.~   "
13684|NCT03387748|"~     In this study, cognitive skills will be identified that underlie the production of iconic~     gestures in individuals with language difficulties. Specifically, what is the role of~     nonverbal semantic processing and visuospatial skills in the use of iconic gestures?~   "
13685|NCT03387735|"~     Multiple chronic conditions are common and expensive among patients aged ≥65 and are~     associated with lower quality of life, poorer response to treatment, worse medical and~     psychiatric outcomes, higher mortality, and higher costs of care.~      The primary purpose of this study is to conduct a randomized clinical trial (RCT) to examine~     the effects of C-CHESS--a web-based intervention--on health outcomes and healthcare use among~     older adults with several chronic health conditions, such as diabetes, high blood pressure,~     high cholesterol, COPD, BMI over 30, congestive heart failure, chronic kidney disease,~     arrhythmia/atrial fibrillation, chronic pain, arthritis.~      The investigator's hypothesis is that patients assigned to TAU+C-CHESS will have better~     quality of life and fewer primary care visits than those assigned to TAU+Internet.~   "
13686|NCT03387722|"~     SevEos is a cross-sectional, multi-center, non-interventional study aimed to describe the~     treatment patterns in 250 severe asthma patients across the Gulf region. In addition, the~     study will determine the current level of asthma control and quality of life in these~     patients; describe the exacerbation patterns; and determine the current levels of blood~     eosinophils for the enrolled patients.~   "
13687|NCT03387709|"~     The purpose of the Get Fit, Be Fit Study is to examine the effect of incorporating pistachios~     in an intensive 4-month cognitive-behavioral weight loss intervention in overweight and obese~     men and women, to examine effects on metabolic factors, and to monitor and examine changes in~     dietary intake and food choices during the intervention, in a randomized controlled study.~   "
13689|NCT03387683|"~     This is a randomised, placebo-controlled, double-blind, parallel-group, international,~     multicentre, Phase IV study to investigate the effects of dapagliflozin on cardiac substrate~     uptake, myocardial efficiency and myocardial contractile work in T2D patients. Eligible~     subjects with T2D before randomisation and fulfilling all of the inclusion criteria and none~     of the exclusion criteria will be randomised in a 1:1 ratio to dapagliflozin 10 mg or placebo~     once daily and treated for six weeks. The study includes five visits.~   "
13690|NCT03387670|"~     Multiple Sclerosis (MS) is a progressive neurological disorder of the brain and spinal cord.~     It affects approximately 120,000 people in the United Kingdom and 2.5 million people~     globally. Most people with MS experience two stages of the disease:~      Early MS - Relapsing-Remitting MS (RRMS), which is partially reversible, and Late MS -~     Secondary Progressive MS (SPMS), which affects the majority of patients, usually after 10 to~     15 years after diagnosis.~      SPMS results from progressive neuronal degeneration that causes accumulating and irreversible~     disability affecting walking, balance, manual function, vision, cognition, pain control,~     bladder and bowel function. The pathological process driving the accrual of disability in~     SPMS is not known at present.~      Immunomodulatory anti-inflammatory disease modifying therapies (DMTs) are increasingly~     effective in reducing relapse frequency in RRMS, however, they have been unsuccessful in~     slowing disease progression in SPMS. This is the overwhelming conclusion from an analysis of~     18 phase 3 trials (n=8500), of which 70% of the population had SPMS, all performed in the~     last 25 years. There is no current disease modifying treatment (DMT) for SPMS.~      In an earlier study (Multiple Sclerosis-Simvastatin 1; MS-STAT1), 140 people with SPMS were~     randomly assigned to receive either placebo or simvastatin for a period of two years. The~     investigators found that the rate of brain atrophy (loss of neurons - 'brain shrinkage'), as~     measured by magnetic resonance imaging (MRI), was reduced in patients receiving simvastatin~     compared to those taking placebo.~      Several other long term studies have also reported that there might be a relationship between~     the rate of brain atrophy and the degree of impairment. The study is designed to test the~     effectiveness of repurposed simvastatin (80mg) in a phase 3 double blind, randomised, placebo~     controlled trial (1:1) in patients with secondary progressive MS (SPMS), to determine if the~     rate of disability progression can be slowed over a 3 year period.~      The results generated from this trial may help to improve the treatment options of people~     with MS. In addition, taking part in this trial will mean regular review by an experienced~     neurologist regardless of the drug that patients are randomly allocated to receive.~   "
13691|NCT03387657|"~     Primary Objective:~      To assess the effects of multiple-dose hydrochlorothiazide (HCTZ) on the steady-state~     pharmacokinetics (PK) of sotagliflozin.~      Secondary Objectives:~        -  To assess the safety and tolerability of multiple-dose sotagliflozin with and without~          co-administration of multiple-dose HCTZ~        -  To assess the effects of multiple-dose sotagliflozin on the steady-state PK of HCTZ~        -  To assess the effects of multiple-dose HCTZ on the steady-state PK of~          sotagliflozin-3-O-glucuronide~   "
13692|NCT03387644|"~     Conscious sedation is usually required during flexible bronchoscopy. Sedation should be done~     without causing respiratory depression or loss of consciousness. The present study was~     designed to evaluate the advantage of pregabalin pre-medication on reducing sedatives and~     respiratory depression for patients undergoing flexible bronchoscopy with dexmedetomidine and~     midazolam.~   "
13693|NCT03387631|"~     Following the development of drug resistance to antimalarial first line treatment of~     uncomplicated malaria with SP by P.falciparum in mainland Tanzania, the Ministry of Health -~     Tanzania, introduced ACTs with AL as first line treatment for uncomplicated falciparum~     malaria in 2006. In the advent of wide scale deployment of ACT together with strengthened~     vector control with LLIN in mainland Tanzania, there is a trend of shrinking the burden of~     malaria. The decline of outpatient malaria cases in recent years and declining entomological~     inoculation rates (EIR) that are currently being recorded in most areas that were before~     considered to be holo/hyper-endemic to malaria transmission is another indicator of the shift~     in the epidemiology of malaria transmission in Tanzania. This current shift provides a new~     and yet critical challenge with regards to assessment and monitoring of the efficacy of the~     first-line treatment specifically considering that artemisinin resistance has been confirmed~     in the Greater Mekong sub-region. The aim of the study was to set up a system for country~     wide representative surveillance to obtain data of the safety and efficacy of AL following~     countrywide use of ACTs for treatment of uncomplicated malaria in Tanzania. The study was~     conducted in the framework of the existing NMCP sentinel sites that are ecological~     representative for malaria endemicity in Tanzania Objective: To assess the efficacy and~     safety of artemether-lumefantrine, artesunate-amodiaquine and dihydroartemisinin-piperaquine~     for the treatment of uncomplicated falciparum malaria in Tanzania.~      Methods: The study was conducted in eight sentinel sites of NMCP (Kyela, Mkuzi, Kibaha,~     Ujiji, Nagaga, Chamwino, Igombe and Mlimba) in mainland Tanzania. Four sentinel sites~     (Mlimba, Mkuzi, Kibaha, and Ujiji) were covered in 2016 and the rest will be involved in the~     second round to be undertaken in 2017.~      Patients were treated with AL for 3 days and the study was conducted from April to Sept 2016.~     The results of this study will assist the Ministry of Health to monitor the efficacy and~     safety of the ACTs in Tanzania, provide baseline data on parasite clearance time and for~     assessing the current national treatment guidelines for uncomplicated falciparum malaria.~   "
13694|NCT03387618|"~     The purpose of this study is to assess the feasibility of investigational Positron Emission~     Tomography (PET) imaging using the new generation digital detector PET technology for new~     procedures beyond the current standard of care.~   "
13695|NCT03387605|"~     This is a randomized, double blind, single center trial to study of the effects of Ivabradine~     vs. Placebo on patients hospitalized for Stage D heart failure (HF)/ and cardiogenic shock~     (CS) who will require continuous infusion of Dobutamine and have developed sinus tachycardia~     (ST) (heart rate >100 beats/min).~      The aim of the study will be to assess the potential of Ivabradine to slow ST and improve~     hemodynamics in patients with stage D HF/CS on Dobutamine treatment.~   "
13696|NCT03387592|"~     This is a randomized phase II non comparative study. Patients with metastatic Neuroendocrine~     Carcinomas (NEC) Grade 3, will be enrolled in the study and will be randomly assigned to~     receive FOLFIRI or CAPTEM as second line treatment. Disease control rate (DCR) and safety are~     primary objectives, secondary objectives are Disease control rate (OS), Progression Free~     Survival (PFS) and quality of life.~   "
13697|NCT03387579|"~     Intestinal failure associated liver disease is a cholestatic liver disease associated with~     prolonged need for parenteral nutrition that can lead to such significant complications as~     liver failure. In the neonatal population, infants with history of intestinal resection and~     short bowel syndrome are at increased risk for this disease. The investigators plan to~     compare two possible lipid dosing preventative strategies including a composite, fish oil~     lipid and soy-based lipid reduction.~   "
13698|NCT03387566|"~     The objectives of this study are to evaluate the safety, tolerability, and pharmacokinetic~     profile of HB002.1M, a human immunoglobulin Fc fusion protein containing domain 2 and~     flanking sequence of vascular endothelial growth factor (VEGF) receptor-1 in subjects with~     age-related macular degeneration (AMD).~   "
13699|NCT03387553|"~     The purpose of this study is to learn more about how to treat patients with HER-2/neu~     positive invasive breast cancer (IBC). HER-2/neu is a type of protein that is known to be~     over-expressed in aggressive breast cancer.~      The study drug for this trial is DC1 study vaccine which is a HER2-sensitized dendritic cell~     (DC) study vaccine. This study vaccine is made from the participant's blood cells collected~     from a procedure called leukapheresis. Dendritic cells are immune cells that can tell the~     immune system to fight infection. In laboratory testing and from previous studies in~     participants, these cells may also help the immune system attack tumors such as breast~     cancer.~   "
13701|NCT03387527|"~     The purpose of this study is to evaluate a new counseling tool for patients deciding whether~     or not to undergo prostate cancer screening. This screening decision aid is a computer~     program that provides individual patients estimates of their risks of prostate cancer~     diagnosis, prostate cancer related death, or death from any cause. The researchers are~     evaluating whether or not patients find this screening decision aid helpful. As part of this~     study, participants will be asked for their response on questionnaires.~      If patients find the screening decision aid helpful, the researchers will make it available~     at other clinic locations.~   "
13702|NCT03387514|"~     The primary objective of this research is to evaluate response to anti-angiogenesis therapy~     via 18F-DCFPyL prostate-specific membrane antigen (PSMA)-based positron emission~     tomography/computed tomography (PET/CT) in patients with metastatic renal cell carcinoma~     (RCC) and to compare qualitatively with conventional imaging response criteria - Response~     Evaluation Criteria In Solid Tumors (RECIST 1.1) and histopathological endpoints of PSMA and~     neovascularization.~   "
13703|NCT03387501|"~     This study evaluate the percentaje of women with thin endometrium who achieve an endometrial~     thickness equal to or greater than 7 mm after administration of PRGF (plasma rich in growth~     factors)~   "
13704|NCT03387488|"~     Particularly in CRT (Cardiac Resynchronisation Therapy), limited accessibility of the~     coronary sinus along with its branches and the mismatch between the region of latest left~     ventricular (LV) contraction and an adequate epimyocardial vein frequently lead to therapy~     failure and might even be responsible for the 30 % non-responders, although this aspect has~     not been thoroughly investigated yet. Further complications such as postoperative micro-~     (i.e. increased thresholds) or macro-dislodgement (i.e. loss of stimulation success) of the~     LV electrodes are frequent complications leading to reoperation or a change of strategy. The~     current transthoracic epimyocardial approach via mini-thoracotomy circumvents the aforesaid~     obstacles and is regarded as the first-choice alternative approach. Participation in the~     trial would prevent patients from this invasive, transthoracic approach and at the same time~     allow the same degree of freedom in lead placement. Risks and complications are in this case~     comparable to the open surgical approach but with a lower risk of intraoperative rib~     fracture, postoperative pain with consecutive pulmonary hypo-ventilation and pneumonia.~      Apart from the benefit of the single individual, societies benefit will include a much higher~     responder rate in CRT patients and less lead-associated infections. Thoracotomy with breach~     of the pleural cavity and single lung ventilation - a procedure that itself bears a high risk~     for postoperative atelectasis, pleural effusion and infection will be avoided.~      In patients on hemo-dialysis and patients who suffer from an infected pacemaker-system,~     extravascular lead placement should be preferred. Again, the current open, transthoracic~     epimyocardial approach via mini-thoracotomy is regarded as the first-choice alternative~     approach.~      Aim of this study is the validation of the feasibility of an alternative, minimal-invasive~     therapy method for implanting a cardiac pacemaker.~   "
13705|NCT03387475|"~     Patients with low-risk MDS verifying the eligibility criteria may be included in the study.~   "
13706|NCT03387462|"~     The researchers are working with a technology company, AiCure, to develop a smartphone app,~     DOT Diary, which combines two drug adherence strategies. DOT Diary reminds people when it is~     time to take their medication, and uses motion-sensing technology to visually and~     automatically confirm the pill was swallowed. The goal of this study is to understand~     people's experiences using this new app while taking HIV pre-exposure prophylaxis (PrEP) for~     the prevention of HIV.~   "
13707|NCT03387449|"~     The goal of this research is to provide limb training in children with hemiplegia using a~     bimanual-to-unimanual training approach. Twenty pediatric patients aged 5-17 years with~     acquired brain injury will receive training on the bimanual-to-unimanual device for a period~     of 9 weeks. During the training, children use both arms to operate robotic arms to play a~     video game. We will assess changes in hand impairment after the training.~   "
13708|NCT03387436|"~     This study evaluates the effect of a collaborative advance care planning intervention on the~     quality of life in palliative oncological patients. Research indicates, that talking about~     wishes for end of life care and death, may improve the quality of life, but can be difficult~     for involved parties.~      The intervention especially developed for this study trys to reduce psychosocial barriers~     that make conversations about these topics difficult. The study will measure the effect of~     the intervention on patients and caregivers quality of life.~      The study will give additional information about implementation of advance care planning~     interventions in different care settings in a complex health care systems.~   "
13709|NCT03387423|"~     This non-interventional study aims to identify key factors that are driving treatment~     decisions by rheumatologists in the treatment of rheumatoid arthritis (RA) patients starting~     treatment with Tofacitinib in a real world setting.~   "
13710|NCT03387410|"~     Phase 1/2a study, second in-man utilising IRDye800BK in ureteric identification using~     fluorescence throughout abdominal surgery. Study is open label, non-randomised prospective~     study.~   "
13711|NCT03387397|"~     The investigators propose to utilize quantitative and qualitative methodology to better~     understand the impact of multiple drug use (polypharmacy) on medication adherence as well as~     the driving forces behind differential adherence in people living with HIV (PLWH) with~     comorbidities. Since the clinical relevance of differential adherence to antiretroviral~     therapy (ART) medication has already been demonstrated and associated with virologic failure~     and a more rapid progression to AIDS and death, it is imperative to understand the driving~     forces behind differential adherence (selective drug taking) and its impact on treatment~     outcomes in PLWH with comorbidities. Moreover, the use of technology to improve medication~     adherence is receiving much attention, and there are several smartphone applications that~     send medication reminders and generate personalized text messages to further motivate users.~     This type of technology could be particularly beneficial to patients who are managing~     multiple medications for multiple conditions. To this end, the investigators propose to use~     the medication adherence smartphone-based application, 'Technology for Engagement And~     Management of Health (TEAMH) to track both medication adherence and medication side effects~     in real-time among PLWH with comorbidities. TEAMH is an interactive health care information~     technology system that is not only patient-centered in that it encourages patient engagement~     in health care self-management, but also offers significant cost savings by directly~     connecting patients with their health care providers allowing providers to quickly address~     any health issue that may arise, thus potentially avoiding costly hospitalizations later on.~   "
13712|NCT03387384|"~     This study aims to describe the demographic characteristics and current status of the aspirin~     use for primary and secondary prevention of cardiovascular diseases in a large, multicenter~     nationwide study~   "
14074|NCT03382665|"~     The study is a multi-center, prospective, non-controlled, consecutive cohort post market~     surveillance study. The objective of this study is to obtain survival and clinical outcome~     data on the Hyperion® system in primary and revision total hip arthroplasty.~   "
13713|NCT03387371|"~     Periodontitis is a chronic inflammatory disease caused by mixed infections with the~     subgingival microbiota being organized as a biofilm that, if untreated, may result in~     breakdown of the periodontal tissues in susceptible individuals. Evidence from intervention~     studies shows that mechanical root debridement significantly improves periodontal health by~     halting the progression of periodontal tissue breakdown. In order to improve effectiveness~     and efficacy of the removal of the subgingival biofilm, Er:YAG laser therapy has recently~     been recommended as an alternative to conventional scaling procedures.~   "
13714|NCT03387358|"~     Nasal bridle securement device (NBSD) is a device used to keep feeding tubes in place. Unlike~     tape, it keeps tubes in place by tying the feeding tube to a fabric string that is looped in~     through one nostril, over the nasal bridge and out the other nostril. The purpose of this~     study is to measure how effective a NBSD is at keeping feeding tubes in place and what effect~     that will have on how many calories ICU patients receive. Also, the another objective is to~     measure what, if any, harmful or undesirable outcomes happen with using a NBSD in our ICU~     patients.~   "
13715|NCT03387345|"~     The purpose of this research was to investigate 5 different formulations of whole grain~     barley and refined white rice against a control of white bread on post-prandial glycemic~     response, as well as self-reported hunger/satiety in a randomized cross-over trial.~   "
13716|NCT03387332|"~     APG-1252 is a highly potent Bcl-2 family protein inhibitor, a promising drug candidate which~     shown high binding affinities to Bcl-2, Bcl-xL and Bcl-w. The preclinical studies have shown~     that APG-1252 alone achieves complete and persistent tumor regression in multiple tumor~     xenograft models with a twice weekly or weekly dose-schedule, including SCLC, colon, breast~     and ALL cancer xenografts; achieves strong synergy with the chemotherapeutic agents,~     indicating that APG-1252 may have a broad therapeutic potential for the treatment of human~     cancer as a single agent and in combination with other classes of anticancer drugs. APG-1252~     is intended for the treatment of patients with SCLC or other solid tumors. Upon completion of~     the Phase 1 dose escalation study to establish the maximum tolerated dose (MTD),~     dose-limiting toxicities (DLTs), and/or recommended phase 2 dose (RP2D), several phase Ib/II~     studies will be implemented accordingly.~   "
13717|NCT03387319|"~     The goal of this study is to determine whether experiencing stress from discrimination may~     increase chronic kidney disease (CKD) progression in African Americans. Study participation~     occurs over the course of 2 days, and participant time burden is expected to be about 4.5~     hours, plus a 24-hour period of wearing a blood pressure monitor.~   "
13718|NCT03387306|"~     Purpose: To analyze the relationship between normal-tension glaucoma (NTG) and serum~     bilirubin levels.~      Materials and Methods: This research included 38 patients with NTG and 38 healthy controls~     with similar age and sex distribution, for a total of 76 subjects. Serum samples were taken~     from all of the subjects, direct serum bilirubin, indirect serum bilirubin and the total~     serum bilirubin were measured.~   "
13719|NCT03387293|"~     The aim of this study was to determine the effect of food insulin index (FII) on metabolic~     parameters and appetite in obese adolescents with insulin resistance. A randomized,~     single-blind and crossover trial included 15 obese adolescents aged 12-18 years with insulin~     resistance. All participants were submitted two different breakfasts: low glycemic index, low~     insulin index (LGI-LII) and low glycemic index, high insulin index (LGI-HII), with a 1-week~     washout period between meals. At time 0 (just before breakfast), 15, 30, 45, 60, 90, 120, 180~     and 240 minutes after the meal, serum glucose, insulin and c-peptide levels were measured and~     appetite was evaluated by visual analog scale. At the end of four hours, participants were~     served ad libitum lunch meal. Then, the foods eaten at lunch were recorded and their energy~     and nutrient analysis was calculated.~   "
13720|NCT03387280|"~     Acute myocardial infarction (AMI) usually occurs suddenly and is associated with considerably~     high mortality rate. The infarct-related artery in inferior wall AMI is usually located at~     right coronary artery (RCA), less often at left circumflex coronary artery (LCX). Inferior~     wall AMI occlusive site before the first right ventricular branch of RCA was more frequently~     associated with right ventricular infarction, which had higher incidence of bradyarrhythmia,~     shock, and in-hospital death. Early recognition of the site of infarct-related artery~     especially combination with right ventricular infarction and respond promptly may result in a~     significant reduction in in-hospital mortality and morbidity. There were several non-invasive~     methods to predict the culprit site, which including: radioneuclear imaging study,~     echocardiography or electrocardiogram. Among these methods, electrocardiogram is one of the~     most simple and convenient tool. Several algorisms have investigated but these algorisms~     included using leads III, II, I, aVL, V1, V2, V3, V5 and V6, which can only differentiate RCA~     and LCX lesions but cannot assure whether the culprit site is located at proximal or distal~     RCA. Thus, the aim of this study is designing a method which is simple and useful in~     identifying the culprit sites in inferior wall acute myocardial infarction (AMI).~      According to the medical record, patients with inferior wall AMI who have no previous history~     of MI (or the first AMI attack) will be enrolled. These patients are divided into 3 groups~     from coronary angiography, depending upon the culprit lesion (1) before (proximal) or (2)~     after (distal) the right ventricular branch of RCA and (3) LCX. A two-step study strategy~     will be performed to analyze which electrocardiographic variables are capable of~     discriminating the culprit site of coronary artery. Using the area under the receiver~     operating characteristic (ROC) curve analysis, we plan to determine which one of the above~     variables is the most powerful criterion in discriminating the culprit site of coronary~     artery. Due to the fact that the case number of the first inferior AMI will be limited, this~     study will be carried out at 3 hospitals in order to collect more cases with the coming year.~   "
13721|NCT03387267|"~     The study procedure of simultaneous VFSS and DDS measurement will be completed in one day and~     the subject will be followed within 2 business days after the study procedure to monitor for~     adverse events.~   "
13722|NCT03387254|"~     The aim of this study is to assess feasibility, acceptability and efficacy of two VRET~     (Virtual Reality Exposition Therapy)session associated with either active anodal tDCS or sham~     tDCS on the ventromedial prefrontal cortex to decrease anxiety related to visual height~     intolerance~   "
13723|NCT03387241|"~     A double blind, double dummy, randomised, multicentre, two arm parallel group study to assess~     the efficacy and safety of FLUTIFORM® pMDI (2 puffs bid) vs Seretide® pMDI (2 puffs bid) in~     subjects aged ≥12 years with moderate to severe persistent, reversible asthma.~   "
13761|NCT03386747|"~     The proposed project will tackle the two most salient problems for children under 5 in~     Brazil: the continued high rates of neonatal mortality, and the large disparities in early~     childhood development. We propose to extend and scale up previously tested and validated home~     visiting programs to the city of Boa Vista in the north region of Brazil. The core~     intervention of the program will be home visits or group meetings to mothers and caregivers~     by trained child development agents. At the core of the program is a detailed curriculum,~     which contains gestation and age-specific topics of child health and development to be~     discussed with caregivers at each encounter.~   "
13724|NCT03387228|"~     The primary aim of this study is to evaluate the feasibility of a full randomized clinical~     trial for assessing the effects of pain education as an intervention for patients with LBP in~     a physiotherapy facility in Nepal. The primary objectives of the study are related to~     feasibility of randomized clinical trial including: (1) willingness to participate in a~     clinical trial, (2) acceptability of random allocation to one of the two study groups, (3)~     feasibility of blinding the assessor(s), (4) eligibility and recruitment rates, (5)~     acceptability of screening procedures, (6) possible contamination between the groups, (7)~     credibility of pain education for patients with LBP, (8) adherence to intervention, (9)~     satisfaction of treatment, and (10) difficulty in understanding the content of pain~     education.~      To address the study objectives, an assessor-blinded, two arm randomized feasibility study~     was designed. Forty patients with LBP will be randomly allocated to one of the two study~     arms, (1) pain education in the experimental group, and (2) evidence based care in the~     control group (CG).~   "
13725|NCT03387215|"~     This is a Phase I/II randomized, double-blind, placebo-controlled, single rising dose study~     in patients with systolic heart failure to evaluate the safety and tolerability of ITI-214.~   "
13726|NCT03387202|"~     This study is aimed to share our clinical experience in an uterine-preserving laparoscopic~     lateral suspension of apical prolapses with mesh operation after minor modifications in~     technique. Transperineal ultrasonography and several questionnaires are used for objective~     and subjective outcomes.~   "
13727|NCT03387189|"~     This study is an evaluation of a Quality Improvement (QI) project addressing delivery of the~     impacted fetal head being conducted at Regions Hospital. This study aims to determine the~     morbidity of second stage cesarean deliveries before and after implementation of simulation~     protocols that address delivery of the impacted fetal head for Ob/gyn surgeons, nursing~     staff, and surgical technicians at Regions Hospital.~   "
13728|NCT03387176|"~     Elevated plasma zonulin levels, which are supportive of a diagnosis of CD (celiac disease) in~     children with gastrointestinal symptoms, may indicate patients with difficult-to-manage NS~     who will benefit from initiation of a GFD (gluten free diet). This pilot study will determine~     whether high plasma zonulin levels can be used as a screening tool to identify patients with~     NS (nephrotic syndrome) who are likely to demonstrate a beneficial response to a GFD. It will~     provide important information about the feasibility of testing the efficacy of a GFD for this~     condition and assist in the design and sample size calculation for a definitive trial to test~     the beneficial effect of this dietary intervention. Although NS is a rare condition in~     childhood, it is a chronic disease that can lead to short- and long-term disability~     especially in those with difficult-to-manage disease. There is an urgent need to develop safe~     and effective new therapies in this subgroup. This project may indicate the utility of a~     common dietary modification, a GFD, to treat these patients. The growing medical use of and~     greater access to gluten-free food items underscore the feasibility and timeliness of this~     approach.~   "
13729|NCT03387163|"~     Real-world evidence of the clinical course of patient symptoms following initiation of~     sacubitril/valsartan via PROs with a patient-centered study design will provide important~     evidence of potentially beneficial outcomes associated with the use of this therapy.~   "
13730|NCT03387150|"~     The purpose of this study is to evaluate the safety, tolerability, and serum concentrations~     of a human monoclonal antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), administered in multiple~     doses and routes to healthy, HIV-uninfected adults.~   "
13731|NCT03387137|"~     The purpose of this study is to evaluate the infectivity, safety, and immunogenicity of a~     single dose of a recombinant, live-attenuated respiratory syncytial virus (RSV) vaccine (RSV~     6120/∆NS2/1030s) in RSV-seropositive children 12 to 59 months of age and RSV-seronegative~     infants and children 6 to 24 months of age.~   "
13732|NCT03387124|"~     The purpose of this study is to evaluate the stool consistency and microbiota composition of~     healthy breastfed infants.~   "
13733|NCT03387111|"~     This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination~     therapy in subjects with SCC who have progressed on or after previous platinum-based~     chemotherapy and anti-PD-1/PD-L1 therapy. Phase 2 will be based on Simon's two-stage optimal~     design.~   "
13734|NCT03387098|"~     This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination~     therapy in subjects with pancreatic cancer who have progressed on or after previous SoC~     chemotherapy.~   "
13735|NCT03387085|"~     This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination~     therapy in subjects with TNBC who have progressed on or after previous SoC chemotherapy.~     Phase 2 will be based on Simon's two-stage optimal design.~   "
13736|NCT03387072|"~     Despite major progress in molecular and phenotypic characterization of primary electrical~     disorders, many (aborted) sudden cardiac deaths (SCD) occur in young victims without~     identifiable abnormalities. Investigator recently identified, in 4 families presenting~     unexplained SCD, a new arrhythmia entity (catecholamine-induced QT prolongation; CIQTP)~     characterized by normal QT duration at rest but major QT lengthening during mental stress~     test (MST).~      Investigators aim to determine the prevalence of this new phenotype in unexplained SCD and~     identify its underlying pathophysiological mechanism.~      More specifically, investigators aim to:~        -  determine the prevalence of CIQTP in unexplained SCD and identify new affected families;~        -  identify the role of mental stress in QT prolongation;~        -  identify the genetics basis underlying this life threatening disease;~        -  perform transcriptomic and electrophysiological profiling of induced pluripotent stem~          cell-derived cardiomyocytes (iPSC-CM) from CIQTP patients to identify putative~          biomarkers and pathophysiological mechanisms.~      MST will be performed, additionally to the conventional screening, in families affected by~     unexplained SCD or long QT syndrome (LQTS) referred to university hospitals of Nantes,~     Rennes, Tours and Brest. Relevance of the MST on the different type of LQTS will be evaluated~     and compared to conventional provocative tests (epinephrine, exercise).~      Whole-genome sequencing will first be performed in 3 distantly affected relatives within each~     of the 4 largest families identified. As previously performed in Nantes, analysis of the~     shared rare variants will allow identifying gene(s) associated with the disease.~      Transcriptomic (high-throughput 3' Digital Gene Expression mRNA sequencing) and~     electrophysiological (96-well automated optical recordings of action potentials and~     patch-clamp recordings of ionic currents, using specific ion channel activators and~     inhibitors) profiling will be performed on iPSC-CMs from 2 affected and one unaffected~     first-degree relatives of these 4 large families.~   "
13737|NCT03387059|"~     This is a multicenter, prospective randomized controlled, interventional investigation to~     assess the safety and clinical performance of Forielle, a medical device for endometrial~     washing, in restoring favorable endometrial condition to implantation after Controlled~     Ovarian Stimulation (COS) during Assisted Reproductive Technique (ART).~   "
13738|NCT03387046|"~     The purpose of this study is to evaluate the improvement in spontaneous recovery from~     clinical deficits at the time of an acute relapse in RR-MS subjects already receiving~     interferon (IFN) beta 1a with D-aspartate (versus placebo) as add-on therapy.~   "
13739|NCT03387033|"~     Patients with sickle cell disease (SCD) and cancer often have complicated courses while~     hospitalized and often deal with pain, anxiety and depression. Advances in the field of~     technology provide potential avenues for innovative and improved care models for our~     patients. Virtual reality (VR) has been recently utilized to improve anxiety and pain in a~     variety of patient populations including children undergoing elective surgery and children~     experiencing intravenous cannulation in the Emergency Department. Patients with SCD and~     cancer, both adults and children, are a group of patients that can benefit from VR as part of~     their care. Over the past four years, our team has successfully implemented several~     self-developed mobile applications (apps) for our patients, in addition to integrating~     objective data (heart rate, activity, stress) from wearable activity trackers. The~     investigators now propose implementing a feasibility study followed by a pilot study and~     randomized-controlled trial of the use of VR in patients with SCD and cancer. The~     investigators plan to assess pain and anxiety prior to the session as well as following the~     session in hospitalized patients and outpatients with SCD and cancer. The sessions will~     include a ten-minute relaxation response introductory narrative segment (deep breathing and~     mindfulness) followed by a ten-minute narrated and immersive VR. Heart rate will be tracked~     using an Apple iWatch for 30 minutes prior to the session, during the session, and following~     the session. We anticipate VR will not only be a feasible method to provide non-pharmacologic~     treatment, but will also significantly reduce pain and anxiety.~   "
13740|NCT03387020|"~     This phase I trial studies the side effects and best dose of ribociclib and everolimus and to~     see how well they work in treating patients with malignant brain tumors that have come back~     or do not respond to treatment. Ribociclib may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as everolimus,~     work in different ways to stop the growth of tumor cells, either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading. Giving ribociclib and~     everolimus may work better at treating malignant brain tumors.~   "
13741|NCT03387007|"~     Adolescents are prone to mental health problems such as post-traumatic stress disorder (PTSD)~     and depression which could become worse in the aftermath of disasters. However, hope can help~     adolescents cope with the challenges better. For resource poor disaster prone settings,~     school teachers can provide timely psycho-social support that could improve mental health and~     hope among adolescents.~      Nepal is a disaster prone country that faced a devastating earthquake in 2015 that claimed~     thousands of lives and left many homeless which could have affected the mental health of~     adolescents.This study was conducted in schools of Dhading, a severely earthquake affected~     district and schools of Myagdi, a least affected district by earthquake in Nepal. The~     intervention focused on training school teachers on psycho-social support for adolescents.~   "
13742|NCT03386994|"~     Descriptive prospective non-interventional multicenter study based on newly collected data of~     Idiopathic Pulmonary Fibrosis patients followed-up for one year in secondary care settings~     (Pulmonology Services)~   "
13743|NCT03386981|"~     Physical activity is a key stimulus for bone metabolism through both direct mechanisms (e.g.,~     as a result of the applied load and/or impact) and indirect mechanisms (e.g., the activation~     of several metabolic pathways and the production of several mediators and effectors that have~     systemic effects). However, different kinds of physical activity exert different effects on~     bone and endocrine system.~      Aim of the study is to investigate the effects of different kinds of physical activity on~     bone metabolism and on the relationships existing between bone metabolism, energy metabolism,~     hormone profile, and organ functionality.~   "
13744|NCT03386968|"~     The purpose of this pilot feasibility study is to assess the feasibility of using the~     Playstation Xbox 360 and Rutgers V-step via a Kinect Sensor with active video game software~     as a part of a physical therapy intervention to improve obstacle negotiation, gait speed, and~     stair negotiation in ambulatory children with Cerebral Palsy (CP) hemiparesis or spastic~     diplegia, or non-progressive brain injury (BI). Children will be assessed using perceptual,~     balance, functional and gait assessments.~   "
13745|NCT03386955|"~     Lung cancer has the highest incidence rate in China and is also a very common cancer in the~     world. BPI-7711 is a potential new drug developed for advanced or recurrent non-small cell~     lung cancer.~      The purpose of this study is to evaluate the safety, efficacy and how the drug is used by the~     body. The first part of the study will recruit 3~6 patients for different dose levels to~     evaluate safety. The dose will increase from the lowest level. In the first part, the study~     will also collect data on how the drug is used by the body to better decide how the drug~     should be taken. The second part of the study is the expansion part. Once efficacy is~     observed in the dose increasing process, additional 20~30 patients will be enrolled to~     further evaluate the anti-tumor efficacy of each dose level. Estimate 50~80 patients will be~     enrolled for both part. A recommended dose will be selected for Phase II study.~   "
13746|NCT03386942|"~     The primary objective of this study is to evaluate the tolerability and safety profile of~     MORAb-202 in participants with solid tumors.~   "
13747|NCT03386929|"~     Patients with advanced/metastatic non-small cell lung cancer (NSCLC) with no documented~     targetable alterations (Epidermal Growth Factor Receptor (EGFR) mutation, Anaplastic Lymphoma~     Kinase (ALK) translocation, ROS1 mutation if available or MET exon 14 skipping mutation if~     available) will receive a tri-therapy associating avelumab, axitinib and palbociclib.~   "
13748|NCT03386916|"~     In case of primary lung cancer, bone metastases biopsy can be done in initial diagnosis or~     follow-up.~      Nevertheless, any study focus on rentability and biopsy complications of lytic bone lesion~     for the context of lung cancer.~      This study aims to demonstrate that CT scan guide percutaneous biopsy of lytic bone lesion~     help to anatomopathologic diagnosis and molecular biology with a low complication rate~     inasmuch a lung cancer is suspected.~      This study is observational, retrospective, one center~   "
13749|NCT03386903|"~     The purpose of the study is to investigate the underlying central nervous mechanisms of~     acupuncture treatment in chronic insomnia patients, from observation changes of gray matter~     and functional connectivity in the default mode network and the salience network by~     functional magnetic resonance imaging, and combine with clinical efficacy assessment to~     analyze the association between the results of imaging and behavioristic.~   "
47964|NCT02939105|"~     Evaluate the safety and efficacy of the ZELTIQ CoolSculpting System using specialized vacuum~     applicators for non-invasive subcutaneous fat reduction of the upper arms.~   "
13750|NCT03386890|"~     Nowadays, the morbidity of Nonalcoholic fatty liver disease (NAFLD) show ascending trend year~     by year, which has become an important public health problem in China. As NAFLD can progress~     to Non-alcoholic steatohepatitis (NASH), cirrhosis and Hepatocarcinoma, the identification~     and quantitative evaluation of liver steatosis and its dynamic changes are crucial. While~     liver biopsy is still the gold standard in the diagnosis of NAFLD, its application is limited~     because of the invasive procedure.The Transient Elastography(TE) combined with the Controlled~     Attenuation Parameter(CAP) is a new non-invasive diagnostic method for fatty liver and liver~     fibrosis.~      In order to evaluate the diagnostic value of non-invasive assessment for the degree of liver~     steatosis and staging liver fibrosis, this non-invasive method will be assessed by the golden~     standard of liver biopsy among 400 NAFLD patients.The treatment protocols will be decided by~     doctor and patient both (treatment protocols and medicine are not required). Blood routine,~     blood biochemistry, abdominal ultrasound and Transient Elastography(TE) combined with the~     Controlled Attenuation Parameter(CAP) are detected during the follow-up.~   "
13751|NCT03386877|"~     The goal of this study is to evaluate if dental pulp stem cells (DPSCs) delivered into~     intrabony defects in a collagen scaffold would enhance the clinical and radiographic~     parameters of periodontal regeneration.~   "
13752|NCT03386864|"~     Assessment of cardiac energy metabolism in patients with impaired glucose tolerance~   "
13753|NCT03386851|"~     This is a Post-Marketing Surveillance (PMS) of Abilify Maintena® Injections in accordance~     with Korean regulations on New Drug Re-examination (i.e. New Drug Re-examination Standards:~     Ministry of Food and Drug Safety(MFDS) Notification).~   "
13754|NCT03386838|"~     This is a study of Nivolumab in combination with experimental medication BMS-986205 compared~     to the standard of care EXTREME regimen in head and neck cancer that has come back after~     initial treatment, or is widespread when first diagnosed.~   "
13755|NCT03386825|"~     The aim of this local NIS(Non-Interventional Study) is to determine the proportion of Belgian~     patients with a duration of treatment(DoT) to Stivarga of 4 months or more in relation to the~     total population of Belgian metastatic colorectal cancer(mCRC) patients who were treated with~     Stivarga between the 1st of July 2015 and 31 July 2017. In addition, this study aims to~     describe the clinical characteristics of Belgian patients with a short- or long-term DoT to~     Stivarga.~   "
13756|NCT03386812|"~     The overall goal of this pilot project is to test the hypothesis that a decline in muscle~     strength precedes the decline in bone strength in men undergoing androgen deprivation therapy~     (ADT) for prostate cancer. The investigators will measure changes in serum biomarkers~     involved in muscle-bone crosstalk, anatomic changes in muscle and bone structure and strength~     that could ultimately contribute to fractures. The findings from this research will inform~     design of interventions to reduce falls and hip fractures in patients undergoing ADT as well~     as application to broader populations of at risk patients.~   "
13757|NCT03386799|"~     Power assisted wheelchairs have specific advantages compared to manual propelled or powered~     Wheelchair. Autonomad Mobility has developed a new device (DUO), the assistance being~     triggered by the motion of the wheelchair and not an push on the hand rim, people who use~     their foot to move or people pushing the wheelchair can be helped by the device as people~     propelling the wheelchair with their arms.~      Furthermore DUO has an option with a longer assistance (AEP+) which can be preferred by some~     people.~      To be referenced and reimbursed by the French health insurance, DUO has to be compared with~     an other power assistance device for wheelchairs, already referenced.~      The study is a comparative study between DUO and the ALBER E Motion. Each patient is his own~     control and is assessed in 4 experimental conditions, with intervals of 3 or 4 days, manually~     propelled, with the E mtion device, with the DUO device and the single push configuration,~     with the DUO device and the AEP+ configuration.~      The main outcome measure will be the user's satisfaction (using 8 items of the ESAT~     questionnaire)~   "
13758|NCT03386786|"~     This is a prospective, single-center, randomized, comparative, controlled study. Penn~     Medicine Princeton Medical Center will enroll a total of 296 subjects (18 years or older) who~     are electing to have total knee or hip replacement surgery. Subjects will be randomized to~     either the treatment group (Health Partner alongside standard care) or the control group~     (standard care alone). Health Partner is a combination of a mobile application and a~     web-based portal. The primary objective is to compare care plan adherence (pre- and~     post-surgery) for Health Partner vs. control subjects. Secondary objectives include~     evaluating all-cause medical resource utilization, communication with health care provider,~     well-being, fear of surgery, confidence in recovery from surgery, sleep, and patient~     satisfaction for 90 days post-surgery. The total planned study duration is approximately 1~     year and 7 months.~   "
13759|NCT03386773|"~     This study will assess the feasibility of using patient-centered, commercial off-the-shelf~     (COTS) health information technology (IT) solutions to collect patient generated health data~     (PGHD) and patient-reported outcomes (PROs) from diverse, low-income disadvantaged~     populations. These data will then be mapped and reported in a way that will allow them to be~     made actionable and used to improve health care quality and delivery. The data mapping will~     be designed for data collection through technology such as mobile apps and wearables, and~     will be intended to support integration into interoperable electronic health records (EHRs),~     clinical information systems, and big data infrastructures.~   "
13760|NCT03386760|"~     The investigators developed an ultra-speed picosecond laser (20ps) with a 20gHz repetition~     rate that provide very promising results in vitro and in ex vivo skin to remove skin tattoos.~      The aim of this study is to evaluate the efficacy and tolerance of a new ultra-speed~     picosecond laser and to compare it to a nanosecond laser for treating black tattoos.~      In a first phase of the study 10 patients with black tattoos will be treated with increasing~     fluencies of the picosecond laser to the optimal parameters in terms of efficacy and~     tolerance.~      In a second phase, 10 additional subjects with black tattoos will be treated after central~     randomization on half of the tattoo with the picosecond laser (with the parameters determined~     in the first phase) and the other half treated with a nanosecond laser.~   "
13780|NCT03386500|"~     In this Phase 1 study, the investigators will conduct a dose-escalation study of the~     combination of BMX-001 with standard radiation therapy (RT) and concurrent 5-fluorouracil~     (5FU)/mitomycin in newly diagnosed Anal Squamous Cell Carcinoma (ASCC) patients. The primary~     objective is to determine the maximum tolerated dose (MTD) of BMX-001 in ASCC patients~     receiving RT and concurrent 5FU/mitomycin chemotherapy.~   "
13762|NCT03386734|"~     SENTICOL III is large prospective multicenter international randomized study designed to~     validate the Sentinel Lymph Node (SLN) mapping technique in early cervical cancer. This~     validation study will compare the outcome of patients with negative SLN (experimental arm)~     vs patients with negative SLN + Pelvic Lymph Node dissection (PLN)(reference arm).~      There will be a quality assurance program which will be developed in participating centers~     with detailed requirements in terms of surgeons' qualifications, pathology qualification, SLN~     ultrastaging, standardization of the procedure, etc. as well as respect of the safety~     algorithm.~   "
13763|NCT03386721|"~     This is an open-label, multicenter, Phase II study to evaluate the antitumor activity of~     RO6874281 in combination with atezolizumab in participants with advanced and/or metastatic~     solid tumors.~   "
13764|NCT03386708|"~     The purpose of this study is verify the efficacy and safety of Human Umbilical Cord~     Mesenchymal Stem Cells (UC-MSC) therapy for patients with Healing Poor after Uterus Injury,~     and exploring the possible mechanisms of umbilical cord mesenchymal stem cell therapy in~     Healing Poor After Uterus Injury disease~   "
13765|NCT03386695|"~     The study goals are,~        1. To determine the test characteristics (sensitivity, specificity, positive predictive~          value, negative predictive value, false positivity rates, false negativity rates) of~          health personnel collected and self collected HPV samples for Hybrid capture explained~          by two different methods (pamphlets/ health education programme).~        2. To evaluate the agreement between self collected HPV samples and health personnel~          collected HPV samples for Hybrid capture with two different methods of education~          (pamphlets/ health education programme).~        3. To study the attitudes, acceptability and barriers of self-collection of specimens for~          HPV DNA testing in three sub groups of population in Maharashtra with two different~          methods of education (pamphlets/ health education programme).~        4. To determine the predictors of self-sampling preference.~        5. To determine the Knowledge, Attitudes and Practices (KAP) regarding cervical cancer and~          HPV infection among these women in pre-intervention and post-intervention period.~   "
13766|NCT03386682|"~     The study will evaluate the safety and performance of the ESTYME® MATRIX Round and Anatomical~     Silicone Gel-Filled Breast Implants in the breast augmentation and reconstruction.~   "
13767|NCT03386669|"~     The aims of this study are: 18F-THK5351 PET(Positron Emission Tomography) can defect the tau~     burden in PSP(Progressive Supranuclear Palsy) and CBS (Corticobasal syndrome)correlating with~     the known NFT(neurofibrillary tangles) topology of those diseases, 18F-THK5351 PET will~     differentiate subjects with suspected tauopathy due to PSP and CBS from subjects with~     suspected synucleinopathy due to idiopathic PD(Parkinson's disease). The distribution of~     PHF(paired helical filament) tau burden will correlate with specific motor and cognitive~     features of PSP and CBS; and regional PHF tau burden will be associated with cortical~     thinning. Together, these efforts will establish the potential for developing 18F-THK5351 PET~     imaging as a biomarker and diagnostic tool for the parkinsonian tauopathies.~   "
13768|NCT03386656|"~     To compare the efficacy and safety of topical tranexamic acid versus placebo in patients~     diagnosed with severe knee osteoarthritis who will undergo prosthetic knee surgery in terms~     of saving blood loss (estimated blood loss, decreased hemoglobin and Decrease in hematocrit).~   "
13769|NCT03386643|"~     Lichen planus is a chronic inflammatory mucocutaneous disease, which often results in oral~     manifestations, receiving the name of oral lichen planus (OLP). Its frequency varies from 0,1~     to 4% of the general population, with a higher incidence in women, around the 4th and 5th~     decades of life. Although the pathogenesis of OLP is related to a immune-cellular response,~     mainly mediated by T lymphocytes, its cause remains unknown. Considering its chronic nature,~     control of OLP aims to reduce symptoms and improve function, and agents with~     anti-inflammatory action, especially topical corticosteroids result in some degree of success~     in most patients, depending on the clinical presentation. However, some cases are resistant~     to the use of corticosteroids, thus justifying the search for new therapeutic options. The~     immunomodulation proved to be one of the main functions of probiotic bacteria, and recent~     studies have shown effect of probiotics on decreasing the expression of inflammatory markers,~     which enables the study of this therapy as an alternative to the control of OLP. Thus, this~     project aims to evaluate the effects of therapy with Bifidobacterium animalis subsp. lactis~     HN019 comparing with clobetasol propionate 0.05% in symptomatic patients with OLP referred~     for diagnosis and treatment of School of Dentistry of Ribeirão Preto - University of São~     Paulo (USP). The impact of the topical therapy (probiotic or corticosteroid) on the clinical,~     histopathological and immunopathological features will be evaluated. This project was~     previously submitted and approved by the Institutional Review Board of the School of~     Dentistry of Ribeirão Preto/USP, and all patients must give informed consent to participate~     in this study.~   "
13770|NCT03386630|"~     Two approved treatments for spinal anesthesia will be compared in women undergoing cesarean~     section.~      It is usual to perform cesarean sections using spinal anesthesia with a local anesthetic~     (bupivacaine) plus some opioid, such as sufentanil or morphine. Both have been shown to~     decrease postoperative pain, but we try to check if one brings more benefit than the other.~   "
13781|NCT03386487|"~     The effects of PF-04457845 (4 mg QD) will be studied in treatment-seeking subjects with a~     cannabis use disorder (n= 260) in a placebo-controlled, double-blind, randomized,~     multicenter, 8-week long parallel-group outpatient study funded by the National Institute of~     Drug Abuse (NIDA). Placebo and PF-04457845 will be provided under an existing agreement with~     Springworks.~   "
13782|NCT03386474|"~     The purpose of this study is to collect data on safety and efficacy of the brolucizumab 6 mg~     drug product intended for commercialization in patients with neovascular age-related macular~     degeneration (nAMD) and to support comparability to the 6 mg drug product used in Phase III.~   "
13783|NCT03386461|"~     The aim of this project is to investigate in elderly women, the effect of combined aerobic~     and resistive training and concomitant supplementation with omega-3 fatty acids on~     adipogenesis, metabolic functions and pro-inflammatory status of adipose tissue and on~     systemic metabolic profile.~   "
13784|NCT03386448|"~     The purpose of this clinical trial is to determine the safety and efficacy of scopolamine~     utilized in conjunction with naltrexone for the treatment of major depression.~   "
13771|NCT03386617|"~     Nausea and vomiting (feeling sick to your stomach and throwing up) are two of the most common~     unpleasant side effects of chemotherapy agents (drugs specifically used to treat cancer) that~     will be used for cancer treatment. If nausea and vomiting are not controlled, they could lead~     to dehydration, poor nutrition and a longer time in the hospital. Nausea and vomiting usually~     occur in response to conditions that affect the gut and the vomiting center, which is an area~     in the brain.~      Netupitant and palonosetron are drugs that are thought to block the activation of certain~     types of chemicals in these areas (brain and gut) and, therefore, to prevent or reduce the~     severity of nausea and vomiting. Nausea and vomiting caused by chemotherapy is classified~     into two patterns based on the time of onset or start. Acute nausea and vomiting start within~     24 hours of chemotherapy administration. Delayed nausea and vomiting starts approximately 2-5~     days after chemotherapy administration. Regardless of when the nausea and vomiting start,~     these symptoms are usually treated with not just one drug, but a combination of drugs. In~     this study you will receive the study drug, which is a fixed combination of netupitant and~     palonosetron.~      This is an open label single arm study. The main purpose of this study or clinical trial is~     to learn more about the effect (how well it works) of the fixed combination of netupitant and~     palonosetron (NEPA) in preventing nausea and vomiting associated with chemotherapy in Hong~     Kong oncology patients receiving (neo)-adjuvant chemotherapy treatment consists of adriamycin~     and cyclophosphamide for breast cancer.~   "
13772|NCT03386604|"~     Chronic obstructive pulmonary disease is characterized by obstruction to pulmonary airflow~     and dyspnea. These characteristics are a consequence of exposure to harmful gases and~     particles that lead to oxidative stress in the lungs together with an exaggerated~     inflammatory response. In addition to respiratory impairment, chronic obstructive pulmonary~     disease has systemic manifestations, nutritional alterations, and exercise limitation.~     Pulmonary rehabilitation is one of the most effective interventions in the treatment of~     chronic obstructive pulmonary disease, with one goal being to improve patient capacity. Whey~     protein supplementation, concomitant with physical activity for patients with chronic~     obstructive pulmonary disease, aims to stimulate protein synthesis and decrease muscle~     catabolism that may be caused by exercise. The investigators aimed to evaluate the effects of~     whey protein supplementation supplementation on the physical capacity, body composition and~     tissue functionality of patients with chronic obstructive pulmonary disease in a pulmonary~     rehabilitation program.~   "
13773|NCT03386591|"~     Intranasal (IN) naloxone administration is an effective alternative to intravenous (IV) or~     intramuscular (IM) naloxone by emergency medical services for opioid overdoses and has been~     used successfully for this purpose as reported in clinical observational studies and a~     randomized controlled trial. Most of the published clinical studies concerning IN~     administration used an improvised kit of 2 mg naloxone/2 mL saline and a mucosal atomizer~     device (MAD), which is not FDA-approved for this indication. Pharmacokinetic (PK) data using~     these kits is not available in the published literature. This study is designed to determine~     the PK of naloxone following one and two IN administrations using the improvised kits~     compared to 2 and 4 mg delivered IN using the FDA-approved Narcan nasal spray device and 2 mg~     administered IM using the Evzio autoinjector.~   "
13774|NCT03386578|"~     The purpose of this study is to evaluate the pharmacokinetics, feasibility, acceptability,~     and safety of a fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate~     (FTC/TDF) as oral daily pre-exposure prophylaxis (PrEP) to prevent HIV during pregnancy and~     postpartum in adolescents and young women and their infants.~   "
13775|NCT03386565|"~     Fifty patients were included in the study, divided into two equal groups (25 in each),~     underwent spinal fusion surgery.Control group: received normal saline.~      Lidocaine group: received lidocaine 2.0 mg/kg slowly IV before induction of anesthesia,~     followed by lidocaine IV infusion at a rate of 2.5 mg/kg/hr until the end of surgery. We~     evaluated the end-tidal isoflurane concentration required to maintain AAI index in the range~     of 20-25 during adult spinal fusion surgery.~   "
13776|NCT03386552|"~     The present investigation is evaluating a method for improving pregnancy outcome of couples~     with unexplained infertility. The method utilizes an adjuvant pre-treatment prior to~     insemination, that is pertubation, i.e. flushing the uterus and fallopian tubes before~     insemination with a specially developed solution with the aim to increase fertility. The~     clinical trial is a phase II double blind, randomized, controlled and multi-center trial .~   "
13777|NCT03386539|"~     The TEAMMATE Trial will enroll 210 pediatric heart transplant patients from 25 centers at 6~     months post-transplant and follow each patient for 2.5 years. Half of the participants will~     receive everolimus and low-dose tacrolimus and the other half will receive tacrolimus and~     mycophenolate mofetil. The trial will determine which treatment is better at reducing the~     cumulative risk of coronary artery vasculopathy, chronic kidney disease and biopsy~     proven-acute cellular rejection without an increase in graft loss due to all causes (e.g.~     infection, PTLD, antibody mediated rejection).~   "
13778|NCT03386526|"~     APG-1387 is a potent, bivalent small-molecule IAP antagonist. APG-1387 has shown strong dose-~     and schedule-dependent antitumor activities in multiple human cancer xenograft models,~     APG-1387 also demonstrates its synergistic effect in combination with immune checkpoint~     inhibitor anti-PD-1 antibody, and such a combinatory effect was further enhanced by~     chemotherapeutic agent. A total of 35 patients with advanced solid tumors or lymphomas have~     been treated with APG-1387 in two Phase I dose-escalation studies in Australia and in China~     Ten dose levels have been tested ranging from 0.3 mg to 45 mg in these 2 studies. Based on~     the preliminary results, APG-1387 is well-tolerated at the dose levels evaluated to date.~     APG-1387 is intended for the treatment of patients with advanced solid tumors and hematologic~     malignancies. After establishing the maximum tolerated dose (MTD), dose-limiting toxicities~     (DLTs), and/or recommended phase 2 dose (RP2D), several Ib /II studies will be implemented~     accordingly to further access the antitumor effects of APG-1387 in combination with either~     pembrolizumab or the chemotherapeutic agents.~   "
13779|NCT03386513|"~     This is an open-label, multi-center, Phase 1 study to determine the MTD and assess the~     safety, tolerability, PK, immunogenicity, and preliminary anti-leukemia activity of IMGN632~     when administered as monotherapy to patients with CD123+ disease.~   "
14075|NCT03382652|"~     The study is a multi-center, prospective, non-controlled, consecutive cohort post market~     surveillance study. The objective of this study is to obtain survival and outcome data on the~     Continuum Metal Bearing System in primary total hip arthroplasty.~   "
13786|NCT03386422|"~     Approximately 10-23% of people suffer from chronic pain in our country. Chronic pain is~     associated with emotional distress (anxiety and depression), physical and social impairment~     and reduction of quality of life in patients who suffer from this condition.~      Self-Compassion is a useful attitude in order to regulate emotions, to be able to accept the~     experience that one is going through and to improve self-care in general population.~     Cognitive-behavioral programs (CBT) have already demonstrated that they are effective in~     order to reduce catastrophizing and passive coping with pain. However, effects of Mindful~     Self-Compassion interventions (based on mindfulness skills but not only) on chronic pain~     condition are still unknown.~      The investigator's principal hypothesis is: MSC program will be, at least, as effective as~     CBT program in order to improve quality of life, self-compassion, self-care and acceptance~     capacity; and as effective as CBT to reduce catastrophizing, anxiety and depression in a~     chronic pain patients sample.~      Moreover, investigators also hypothesize that MSC program will be, at least, as effective as~     CBT program in order to maintain the achieved benefits in a 6 months follow-up.~      Investigators will conduct a Randomized Controlled Trial with two treatment arms in a chronic~     pain sample of patients of Hospital Universitario La Paz, Madrid.~      After all recollection of data is done, investigators will conduct statistic analysis in~     order to accept or refuse our hypothesis.~   "
13787|NCT03386409|"~     This study aims to describe the baseline rate of safe firearm storage device use in the homes~     of pediatric patients with mental health complaints treated in the Emergency Department (ED)~     and/or inpatient psychiatric unit of an urban tertiary pediatric hospital.~      Follow-up data will be collected to ascertain any change(s) in the rate of safe firearm~     storage device use after patients have been treated for a mental health complaint, which~     includes standardized recommendations for safe firearm storage practices. This study also~     involves an intervention to distribute safe firearm storage devices to families of pediatric~     mental health patients during their hospital visit, and assesses whether safe storage device~     distribution impacts reported future rate of firearm safety device use.~   "
13788|NCT03386396|"~     This study will help us learn more about how what a child eats can affect how their brain~     works.~   "
13789|NCT03386383|"~     The purpose of this study is to examine the feasibility, acceptability, and gather~     preliminary data on outcomes of a 3-month mHealth intervention to promote physical activity~     among adolescent and young adult (AYA) cancer survivors compared to a delayed intervention~     control group.~   "
13790|NCT03386370|"~     To evaluate, in a controlled setting, the early safety and effectiveness of the~     Penumbra/Indigo aspiration thrombectomy Systems (San Francisco, California), and to define~     optimal technique for the use of these systems in patients with confirmed peripheral acute~     occlusions.~   "
13791|NCT03386357|"~     Randomized phase II study of immune stimulation with Pembrolizumab and radiotherapy in second~     line therapy of metastatic head and neck squamous cell carcinoma.~   "
13792|NCT03386344|"~     Primary Objective:~      To demonstrate the superiority of sotagliflozin dose 1 versus placebo with respect to~     hemoglobin A1c (Hb1Ac) reduction in patients with type 2 diabetes (T2D) who have inadequate~     glycemic control on diet and exercise only or with a stable antidiabetes regimen.~      Secondary Objectives:~        -  To compare the effects of sotagliflozin dose 1 and dose 2 versus placebo with respect to~          the percent change in bone mineral density (BMD) at lumbar spine, total hip, and femoral~          neck, measured by dual-energy X-ray absorptiometry (DXA).~        -  To demonstrate the superiority of sotagliflozin dose 1 versus placebo on change in body~          weight (BW), fasting plasma glucose (FPG), systolic blood pressure (SBP) for all~          patients; and to evaluate the proportion of patients with a HbA1C <7%.~        -  To demonstrate the superiority of sotagliflozin dose 2 versus placebo with respect to~          HbA1c reduction; change in BW, FPG, and SBP for all patients; and to evaluate the~          proportion of patients with HbA1c <7.0%.~        -  To evaluate the safety of sotagliflozin dose 1 and dose 2 compared with placebo.~   "
13793|NCT03386331|"~     This is a six months intervention study in non-diabetic overweight and obese subjects.~     Subjects will be counseled for weight loss through diet and exercise. Diet and exercise will~     be recommended as per the regular norms for weight loss (weight loss ≥10% from baseline~     weight will be considered as a significant loss of weight) for overweight and obese subjects.~     A sample size of 90 subjects was calculated but assuming a drop out rate of 20%, 110 subjects~     will be enrolled. Enrolled subjects will be measured at every visit (monthly) for weight,~     body composition measures of abdominal obesity and skin folds. They would be assessed for~     compliance with diet and exercise. Detailed analysis of body composition including DXA,~     biochemical analysis will be performed at enrollment and after six months intervention.~     Statistical analysis will be performed to find association between measures of body~     composition for weight loss and genotypes of the VDR polymorphisms.~   "
13794|NCT03386318|"~     Oxycodone is an opioid frequently given orally as a premedication prior to any kind of~     surgery. The initial studies are performed on healthy testpersons and is not given in~     surgery. The investigators want to explore serum concentration over time (5h) and relate this~     to Visual Analoge Scale (VAS) postoperatively but also to given mg/kg~   "
13795|NCT03386305|"~     This study will evaluate the medication adherence, clinical efficacy, and safety of~     EnvarsusXR in stable post liver transplant patient using a Phase III randomized controlled~     study. The primary outcome is change in medication adherence from baseline to the end of the~     study, assessed using a validated instrument (BAASIS- Basel Assessment of Adherence with~     Immunosuppressive medication Scales) and standard deviation of Tacrolimus levels.~   "
13796|NCT03386292|"~     The publications on prevalence and risk factors of urinary and anal incontinence in women~     were performed mainly in Europe and America. Consequently, result extrapolation to Tunisian~     population may not be a good practice which justifies this study and demonstrates its~     importance.~   "
13818|NCT03386006|"~     The prevalence of overweight in America is a national public health crisis. As more people~     consider bariatric surgery for the treatment of severe obesity, it is imperative to identify~     factors influencing surgical outcomes. Technology, particularly the Noom Coach platform,~     offers a unique opportunity to improve standard interventions utilized in bariatric surgery~     programs. This study plans to test the efficacy of the Noom Coach platform on patients'~     adherence behaviors and psychosocial factors compared to standard care.~   "
13797|NCT03386279|"~     This is a Phase 1, single-dose, randomized, 3-treatment, 3-period cross-over, sponsor-open,~     placebo-and positive-controlled trial to be conducted in approximately 36 adult healthy~     volunteers. There will be 3 crossover treatments: PF-04965842 600 mg (A), placebo (B) and~     moxifloxacin 400 mg (C). Treatment assignments to PF-04965842 and placebo will be blinded to~     the subjects, investigator and Clinical Research Unit (CRU) staff (except pharmacist) but~     open to the sponsor. Moxifloxacin administration will be unblinded. Dosing in each of the 3~     treatment periods will be separated by a washout period of at least 5 days~      Screening evaluation will occur within the 28 days prior to dosing in the first treatment~     period. During each treatment period, eligible subjects who meet the entry criteria will be~     admitted on Day -1, prior to treatment administration on Day 1, and will reside in the CRU~     until completion of protocol assessments on Day 2. There will be a washout of at least 5 days~     between dose administrations in consecutive crossover treatment periods. After completion of~     the 3 study periods or upon withdrawal from the study, subjects will return for a follow-up~     visit approximately 7-14 days following last dose of investigational product. Further~     follow-up contact will be made at least 28 calendar days and up to 35 calendar days after the~     last administration of the investigational product to capture any potential AEs and~     concomitant treatments, and to confirm appropriate contraception usage, contact with the~     subject may be done via phone. For each subject, the duration of participation from Day 1~     admission to follow-up visit will be approximately 10 weeks. The follow-up call will occur up~     to 4 weeks after the follow-up visit.~      In each treatment period, the subject will be admitted to the CRU the day prior to dosing.~     Genotyping samples for CYP2C19 and CYP2C9 will be collected pre-dose in Period 1 only. The~     subject will receive a single dose of the assigned trial medication in the morning of Day 1.~     Triplicate 12-lead ECG measurements (approximately 2 minutes apart) will be performed on Days~     1 and 2 of each treatment period as follows: -1, -0.5 and 0 hours pre-dose and at 0.25, 0.5,~     1, 2, 3, 6, 12, and 24 hours post-dose. Blood samples will be collected following the 0 hour~     and post-dose ECG measurements at the same time-points to evaluate the PK of PF-04965842 and~     moxifloxacin (if needed). Clinical safety laboratory tests will be performed on Day -1 and at~     24 hours on Day 2, and vital signs (supine pulse rate and BP) will be monitored pre-dose and~     at 2 and 6 hours post-dose on Day 1 and at 24 hours on Day 2. The subject will be discharged~     from the CRU after completing all trial procedures of the particular treatment period in the~     morning of Day 2 (24 hours post-dose).~   "
13798|NCT03386266|"~     CMT is a rare disease for which novel treatments are being developed. Evaluation of~     intervention efficacy is hampered by slow progression and lack of sensitive outcome measures.~     Primary goal of the project is to identify and validate RNA and protein derived biomarkers in~     blood of CMT patients for selected outcome measures over 2 years. The investigators expect to~     develop more responsive outcome measures and circulating biomarkers to improve assessment of~     intervention efficacy in forthcoming therapeutic trials.~   "
13799|NCT03386253|"~     In this pilot study, the feasibility of using tDCS (a non-invasive brain stimulation~     technique) while performing a task requiring cognitive flexibility will be examined in~     smokers and initial data will be collected regarding the effect of tDCS on smoking cessation~     behaviors. Smokers will be randomized to receive either active or sham tDCS daily for 5 days~     after which they will attempt to quit smoking. Smoking behavior after the attempted quit date~     will be assessed at four weekly visits.~   "
13800|NCT03386240|"~     Abdominal closure with antibacterial-coated sutures has been shown to reduce wound infections~     after a number of surgical procedures, but none of the previous trials included cesarean~     delivery. Our objective is to determine whether use of antibacterial-coated sutures reduces~     surgical site infection (SSI) after cesarean delivery.~   "
13801|NCT03386227|"~     The objective of this study is to determine the impact on clinical pregnancy rate of~     withholding routine prophylactic antibiotic therapy during IVF. The hypothesis is that~     withholding antibiotic prophylaxis will be non-inferior to routine administration. To test~     this hypothesis, the investigators will conduct a randomized controlled non inferiority~     trial. Additionally a pilot RCT will be conducted among the first 50 patients undergoing~     their first cycle enrolled to evaluate the microbiome across the IVF cycle, in addition to~     the human virome.~   "
13802|NCT03386214|"~     Based on the investigators' preclinical data, the combination of pevonedistat and ruxolitinib~     may provide greater clinical responses in patients with myelofibrosis compared to ruxolitinib~     monotherapy via inhibition of NFκB in addition to JAK-STAT signaling.~   "
13803|NCT03386201|"~     Open label prospective, non-randomised proof of principle study assessing the use of~     methylene blue fluorescence cholangiography.~   "
13804|NCT03386188|"~     Although the primary motor cortex is considered has the common final pathway of motor~     commands, it is influenced by several structures as, for example, the premotor cortex and the~     posterior parietal cortex which are involved in motor planning and programming and which~     integrates movement-induced sensory impute (parieto-frontal circuits). Several studies have~     shown that there are some direct functional connections between the premotor cortex and the~     posterior parietal cortex and from these two regions to the primary motor cortex. The~     posterior parietal cortex can then be considered as a sensorimotor interface whose function~     in planification and motor control of upper limb is well demonstrated. The hypothesis is that~     the posterior parietal cortex could participate to the modulation of motor cortex~     excitability by proprioceptive sensory inputs namely long latency afferent inhibition and~     afferent induced facilitation.~   "
13805|NCT03386175|"~     the aim of the study is to evaluate the efficiency of the therapy with negative pression~     (TPN) and instillation in the debridement of chronic wound~   "
13806|NCT03386162|"~     SAFIR PI3K is an open-label multicenter phase II randomized trial, comparing alpelisib plus~     fulvestrant to maintenance chemotherapy in patient PIK3CA mutated with HR+/Her2- metastatic~     breast cancer who do not present progressive disease after 6-8 cycles of 1st or second line~     chemotherapy.~      The primary objective is to determine whether treatment with alpelisib plus fulvestrant~     prolongs progression-free survival (PFS) compared to maintenance chemotherapy in patients~     PIK3CA mutated with hormone receptor positive (HR+), HER2-negative advanced breast cancer,~     who do not present a progressive disease after 6-8 cycles of chemotherapy.~   "
13807|NCT03386149|"~     This randomized controlled clinical trial is designed to evaluate the efficacy and safety of~     Bosinji on low back pain and radiating pain of lumbar herniated intervertebral disc (L-HIVD)~     by assessing pain, function, and quality of life.~   "
13808|NCT03386136|"~     This study is a non invasive study to see if 100% oxygen therapy will help to resolve an~     intestinal obstruction.~   "
13819|NCT03385993|"~     D.R.E.A.M.S. will assess an immersive digital reality-augmenting system in reducing the~     occurrence of cognitive, behavioral, and emotional consequences of critical illness and~     environmental exposures that are risk factors for the development of delirium.~   "
13831|NCT03385837|"~     A prospective longitudinal and observational clinical study will be conducted with~     hospitalized heart failure patients.The main purpose is to know the level of physical~     activity of these patients after their discharge in relation to the orientation received~     during their hospitalization and identify the barriers perceived by these patients to~     participate in a cardiac rehabilitation program. The outcomes are available by telephone~     calls in 30 and 90 days after discharge.~   "
13809|NCT03386123|"~     There is evidence that CBT for insomnia (CBTi) is an effective treatment for sleep~     disturbance both as a primary problem and when co-morbid with other health problems, such as~     chronic pain.~      This study will investigate the effectiveness of CBTi as a treatment for tinnitus related~     insomnia. Tinnitus patients reporting clinically significant insomnia will be offered~     sleep-specific treatment. Six sessions of CBTi will be offered to one group of patients and 2~     sessions standard audiological care (psycho-education and sleep hygiene) will be offered to~     another group. Both groups will be offered sound enrichment at night. In order to take~     account of the possible effects of clinical contact a third group will be offered 6 sessions~     of support without a focused tinnitus or sleep intervention. Accepted measures of sleep~     disturbance will be used as well as measures of tinnitus complaint.~      All treatment/contact will be provided at the Royal National Throat Nose & Ear Hospital.~     Participants will be involved in the study (inc. baseline period {2 weeks}, intervention {8~     weeks} and follow-ups {4 and 20 weeks}) for 34 weeks.~   "
13810|NCT03386110|"~     This project tests the feasibility, acceptability, and preliminary efficacy of the Couples~     Health Project (CHP). CHP is a brief (3-session) couples-based Motivational Interviewing~     intervention which addresses drug use and sexual HIV transmission risk among partnered HIV~     negative YMSM (ages 18-29). The proposed project includes a randomized controlled trial (RCT)~     involving 50 couples who are randomized to complete either the CHP intervention or an~     attention-matched education control condition.~   "
13811|NCT03386097|"~     At a given level of serum cholesterol, patients with T2D have an increased risk of developing~     atherosclerosis compared with nondiabetic subjects.~      In a previous study we showed that the interstitial fluid-to-serum gradient of LDL and VLDL~     cholesterol is reduced in T2D patients compared with healthy controls. This was not found for~     HDL cholesterol. However, the cholesterol transporting function of HDL particles from~     interstitial fluid from patients with T2D were lower than in healthy controls. We hypothesize~     that that the apo B-containing particles in T2D patients are more susceptible to be retained~     or consumed in the extravascular space.~      We are to study if skin biopsies from T2D patients contain more cholesterol than biopsies~     from healthy controls. We hypothesize that samples from T2D patients are richer in~     cholesterol, which could explain why VLDL and LDL cholesterol are lower in relation to their~     plasma levels in T2D.~   "
13812|NCT03386084|"~     Lumbar pain is considered one of the most frequent health problems faced by human populations~     on a global scale.~      This study will be carried out to evaluate the efficiency of motor control treatments~     combined with diathermy in patients diagnosed with acute lower back pain, focusing upon the~     potential for accelerated patient recuperation if both treatments are applied simultaneously~     and jointly.~   "
13813|NCT03386071|"~     The dosage of trametinib for oral administration is 2mg once daily. The patient is instructed~     to take the trametinib oncedaily dose at approximately the same time each day, by mouth with~     approximately 200 mL (almost 1 cup) of water on an empty stomach, either 1 hour before or 2~     hours after a meal.~   "
13814|NCT03386058|"~     Spinal cord stimulation is a minimally invasive surgical treatment for severe, chronic,~     neuropathic pain that is refractory to conventional treatment.~      The treatment consists of an electrode implanted in the epidural space of the spinal cord,~     either via a percutaneous approach (using the so-called percutaneous leads) or via a surgical~     (hemi-) laminectomy (using the so-called surgical leads or plate leads).~      It is a well-known clinical observation that when activating or deactivating SCS stimulation,~     there is a variable interval before the patient perceives a clinical effect of the change.~     This variation goes by different names (carryover, echo, after effect, etc.) and might be~     dependent on the clinical condition and treatment duration. To our knowledge only very little~     research has been published on the topic of carryover effects; a recent study showed that the~     interval is highly variable between patients.~      While patients may experience immediate pain relief at the onset of SCS treatment, the effect~     in patients with a long-term SCS treatment history may have different characteristics,~     possibly due to ongoing changes in the nervous system.~      The aim of this pilot study is to lay the foundation for investigating the carryover effects~     in spinal cord stimulation.~      This will be carried out in a mixed population of patients with different indications for~     SCS, and with different treatment durations.~      Patients will be asked to deactivate their device via their remote control or with a magnet~     in a standardized fashion.~      They will be asked to reactivate the device when specific parameters have been met, and the~     time is recorded.~   "
13815|NCT03386045|"~     To compare the toxicity, rate of local control, biochemical failure rate and quality of life~     of three different radiotherapy techniques (moderate hypofractionation, stereotactic body~     radiotherapy (SBRT) and standard radiotherapy plus 2 fractions of SBRT (BOOSTER)~   "
13816|NCT03386032|"~     This is a study to investigate the clinical effectiveness of the Sponsor's experimental cream~     treatment on eczema as measured by visual grading of SCORAD (scoring of atopic dermatitis).~   "
13817|NCT03386019|"~     Background: Lower extremity edema is often seen after exercise in healthy individuals,~     especially sprinters, in sports physical therapy practice. Edema is defined as the excessive~     fluid accumulation in the interstitial space. Recent studies showed that there could be an~     increase in fluid up to 31.2 ml after a 15-minute running bout in healthy individuals. Fluid~     accumulation may be resulted from (1) high intensity training, (2) compression of blood and~     lymph vessels due to increased soft tissue tension and (3) the effect of gravity. Lower~     extremity edema not only causes great impact on athlete's recovery and performance, it could~     also lead to fibrosis, dysfunction and contracture. The pilot study showed that lower~     extremity edema not only existed post-exercise, and decreased ankle circumference was found~     after a 5-minute massage session, not only when compared to the status after exercise, but~     also when compared to the baseline (resting). The result also showed lower extremity edema~     may exist both during resting and after exercise. However, no studies to date investigated~     the solutions to decrease lower extremity edema during resting and after exercise in~     sprinters. Massage has been proven beneficial to athletes by increasing range of motion,~     promote recovery and increase skin blood flow, however, no study investigated the effect of~     massage on lower extremity edema and compared that to different common recovery modalities~     such as cold water immersion and static-stretching.~      Purposes: To explore the effects of massage on sprinter's gastrocnemius after running on~     edema and strength with immediate and short-term follow ups.~      Methods: This study will recruit both male and female sprinters age between 20-30 years old~     who participate in the event of 100, 200 and 400 meter sprints. After individuals'~     enrollments and baseline data collections, all subjects will receive all three different~     treatments (massage, cold water immersion and static stretching) in randomized orders a week~     apart, respectively. Outcome measures are: visual analogue scale (VAS) score, lower leg~     volume, pressure pain threshold and horizontal jump distance. All measurements will be~     recorded at baseline, immediately after exercise, immediately after treatment, and 10 minutes~     after treatment as the follow up. Descriptive statistics will be used for participants'~     characteristics. Three-way ANOVA (3 treatments x 4 times x 2 legs) with repeated measures~     design will be used to detect differences, and post-hoc analysis will be used when~     interactions are identified. p value of < .05 will be used in this study.~   "
13820|NCT03385980|"~     DONUM is an observational prospective independent protocol for patients with advanced lung~     cancer, colorectal cancer or cancer of unknown primary, willing to donate their tumor tissue~     samples post mortem for biomedical research purposes. All patients who fulfill the inclusion~     criteria will be eligible for the study after giving their Informed consent. Informed Consent~     will be obtained in two steps. During the pre-information step patients will be acquainted~     with the existence of a post-mortem cancer tissue donation research program governed by the~     DONUM protocol. If the patients manifest interest to participate into the program (in~     writing) during the pre-information step, they will proceed to step 2 and undergo the final~     informed consent process.~   "
13821|NCT03385967|"~     This is a prospective, randomized, double blind study of adding dexmedetomidine to~     ropivacaine for Brachial plexus block and assessing the analgesia with VAS pain scales(0-10),~     Satisfaction scale by VAS scale(0-10) and time to first analgesic consumption. This study~     mainly aims to investigate whether addition of dexmedetomidine helps in increasing the~     duration of analgesia.~   "
13822|NCT03385954|"~     Repetitive Strain Injuries (RSI) or Work-Related Ostomuscular Disorders (WRMD) are~     musculoskeletal disorders. Nursing is one of the categories of workers most affected, due to~     the inherent functions they perform in their daily activities. The objective of this study is~     to evaluate the effects of a distance education program of prevention in RIS/WRMD on the~     quality of life of a nursing group.~   "
13823|NCT03385941|"~     This examines in-vivo microwave sensing to measure a radio- frequency signal propagating~     through the wrist and, based on this information, establish a correlation of measured~     parameters with the integral bone density. This radio- frequency device is designed to obtain~     an integral estimate of bone density (osteoporotic vs normal).~      The measurements can be done in three ways. The first method (Method 1) utilizes Received~     Signal Strength (RSS) of an RFID tag array at 915 megahertz located on the top of the wrist.~     The transmitting antenna located on the bottom of the wrist is connected to an RFID reader.~     In that way, the signal travels twice across the wrist: from the reader to the tag and vice~     versa.~      The second method (Method 2) is to use only one transmitting antenna, connect the~     transmitting antenna to a portable Network Analyzer and measure the reflection coefficient,~     S11, of the antenna itself. This method does not imply that the entire signal will travel~     back and forth through the wrist, although its significant portion will. This method is,~     however, broadband and allows us to measure antenna resonances, which are very sensitive to~     the wrist composition.~      The third method (Method 3) is to use both transmitting and receiving antennas, connect the~     antennas to a portable KeySight Network Analyzer and measure the transmission coefficient,~     S21, of the antenna pair. This method implies that the entire signal will travel through the~     wrist once. This method is also broadband and allows us to measure decay of the radio-signal~     in the wrist over a band of frequencies.~      The two last methods could be combined together.~   "
13824|NCT03385928|"~     The study will be prospective phase II randomised, double-blind, placebo-controlled,~     investigator-driven trial in acute intracerebral haemorrhage patients.~      The study has 2 arms with 1:1 randomisation to either intravenous Tranexamic acid or placebo~     and will test the hypothesis that ICH (intracranial haemorrhage) patients treated with~     intravenous tranexamic acid within 2 hours of symptom onset will have lower rates of~     haematoma growth than compared to placebo.~   "
13825|NCT03385915|"~     The FinnValve investigators planned a nationwide registry to investigate the early and late~     outcome of transcatheter aortic valve implantation (TAVI) compared to surgical aortic valve~     replacement (SAVR) in patients with aortic valve stenosis performed from 2008 to 2017 at five~     Finnish University Hospitals. Data will be collected in a dedicated electronic case report~     form.~   "
13826|NCT03385902|"~     The purpose of this study is to evaluate the impact of the optimal and late initiation of~     dialysis on the mortality and quality of life in advanced chronic kidney disease patients by~     the Dialysis Initiation based on Fuzzy mathematics Equation (DIFE), which is a novel equation~     for the assessment of timing of dialysis initiation established by Fuzzy mathematics.~   "
13827|NCT03385889|"~     The effects of cervical spine manual therapy, including mobilization and manipulation, on~     cervical spine range of motion, joint position sense, and balance is unknown among~     individuals with cervicogenic headache. Previous studies have indicated improved frequency of~     headache, decreased perceived disability, and demonstrated improved neuromuscular function~     following upper cervical manipulation. Other authors report improved cervical spine range of~     motion, joint position sense, and balance following cervical spine manual therapy for~     individuals with cervicogenic dizziness. Through an experimental design, this study aims to~     determine the effects of cervical spine manual therapy on variables such as cervical spine~     range motion, joint position sense, and balance among individuals with headache of a cervical~     spine origin.~   "
13828|NCT03385876|"~     Rapid Whole Genome Sequencing (rWGS) has proven to provide much faster diagnoses than~     traditional clinical testing, including clinical Whole Exome Sequencing (WES) and standard~     Whole Genome Sequencing (WGS). This collaborative study seeks to provide rWGS as a research~     test to additional pediatric hospitals nationwide to assist in the rapid diagnosis of acutely~     ill children suspected of a genetic condition. The study will examine diagnosis rates,~     changes in clinical care as a result of a genetic diagnosis, and health economics including~     potential cost-effectiveness of rWGS. This study will also serve as a biorepository for~     future research on samples and data generated from genomic sequencing.~   "
13829|NCT03385863|"~     Since exogenous surfactant replacement therapy was first used to prevent neonatal respiratory~     distress syndrome (NRDS)，it has become the main method of treatment of NRDS. However, in some~     infants, death is inevitable despite intensive care and surfactant replacement therapy,~     especially in near-term and term infants. The first goal of our study is to compare the~     therapeutic effect of pulmonary surfactant of infants at different gestational ages and to~     investigate whether exogenous surfactant replacement therapy is effective for all newborns~     with RDS. The second goal of our study is to further analyze the risk factors and causes of~     RDS in early preterm infants and near term/term infants.~   "
13830|NCT03385850|"~     The investigators aim to evaluate the roles of Th17/Treg cells and IL-23/IL-17 axis in the~     mechanisms of early enteral nutrition (EEN) correcting immune imbalance of sepsis by means of~     improving the intestinal flora disturbance. The results of this study would lay the~     foundation for revealing the mechanisms of EEN improving immune imbalance of sepsis and~     provide a new idea to the early treatment of sepsis~   "
13832|NCT03385824|"~     Traumatic brain injury (TBI) has been conceptualized as a chronic health condition,~     warranting self-advocacy for health management services across the lifespan. Successful~     self-advocacy requires a combination of cognitive and communication skills (problem solving,~     organization, negotiation, etc), which may be impaired following TBI. This project focuses on~     developing and testing the efficacy of an intervention to enhance self-advocacy skills in~     individuals who have sustained TBI. This two-arm, randomized controlled trial will include~     approximately 74 participants, recruited in 4 waves of approximately 18-20 per wave, with~     each wave recruited from a different geographic area of the state. The primary hypothesis~     states that participants receiving the treatment intervention will demonstrate significantly~     greater improvements in self-advocacy beliefs (SAS) from baseline to post-intervention as~     compared to participants in the control group. Treatment will consist of interactive~     4-session workshops along with 2 booster phone calls. Control participants will receive a~     copy of a self-advocacy workbook after all assessments are completed. Baseline,~     post-treatment and two follow-up assessments will take place.~   "
13833|NCT03385811|"~     The study design is a cross-sectional study. Purposive sampling will be conducted in three~     hospitals in the central of Taiwan. The participants will include physicians, nurse~     practitioners and nurses. The number of 550 participants will be recruited. The measurements~     are questionnaires include demographic data, professional quality of life scale (ProQOL), Job~     Involvement Questionnaire (JIQ), SF-36 and intention to stay questionnaire.~   "
13834|NCT03385798|"~     The study is a randomized clinical trial (RCT) including patients undergoing robotic assisted~     cystectomy with intracorporeal ileal conduit at four large university hospitals in Denmark.~      If included, the patients will be randomized 1:1 to two study arms: 1) Standard arm with~     current procedure where intracorporeal bowel anastomosis is performed with the 60 mm EndoGIA~     stapler, or 2) Experimental arm where the bowel anastomosis will be performed totally robotic~     with the Endowrist Intuitive robotic stapler with 2 subsequent elongated 45 mm magazines for~     the side-to-side anastomosis.~      Primary outcome will be postoperative bowel function where a better bowel recovery is~     anticipated in the experimental Endowrist arm whereas serious complications are expected to~     be non-inferior to the current standard.~   "
13835|NCT03385785|"~     Calcified aortic stenosis is the most frequent valvulopathy in Europe and North America.~     Aortic stenosis is an obstacle to the ejection of blood from the left ventricle to the aorta~     and leads to morphological changes in the left ventricle and hemodynamic modifications.~      Intrinsic ventricular performance can be characterized using three parameters:~        -  Ventricular elastance (Ees for End Systolic Elastance) which represents the index of~          ventricular contractility independently of the load.~        -  Arterial elastance (Ea for Arterial Elastance) which represents the post-load~        -  The ventriculo-arterial coupling index (Ees / Ea) which represents energy efficiency.~      For patients with high surgical risk (EuroSCORE II> 6), TAVI (Transcatheter Aortic Valve~     Implantation) is recommended for aortic valve replacement. Many complications may occur after~     TAVI (haemorrhagic, embolic, renal, myocardial ischemia). Post-TAVI complications may also be~     cardiac decompensation of the underlying cardiac disease to cardiogenic shock. However,~     literature on left ventricular performance after aortic valvular replacement is poor because~     of the difficulty and invasiveness of the analysis involved.~      Cardiac energy analysis plays an additional role in understanding the clinical patients~     conditions. On this point, cardiac energy modifications, based on ventriculo-arterial~     coupling, could be indicators of cardiac function. Two methods (ultrasound and pulse contour)~     are used to understand and explore the ventriculo-arterial coupling, preload, postload,~     contractility and hemodynamic changes interactions.~      Echocardiography allows the Ees / Ea and SW / PVA (Stoke work/ pressure-volume area) ratios~     mesurements. PRAM (Pressure Recording Analytical Method) through the MostCare® monitor, gives~     common hemodynamic parameters and more specific parameters such as arterial elastance (Ea)~     cardiac cycle efficiency (CCE), dP / dt. Cardiac cycle efficiency (CCE) is an exclusive~     variable that describes the hemodynamic performance in terms of energy expenditure in the~     patient being followed.~      TAVI procedure is an acute model of ventriculo-arterial coupling modification by treatment of~     the ventricular ejection obstacle. The PRAM method evaluates the ventriculo-arterial~     coupling. The aim of our study is to evaluate by PRAM the changes in cardiac energy variables~     before and after aortic valve replacement by TAVI~   "
13836|NCT03385772|"~     This study aims to determine the efficacy of the sphenopalatine ganglion block in the~     treatment of post-dural puncture headache in post-partum women at the Brigham and Women's~     Hospital by measuring VAS scores at times between 0 and 24 hours after the block. We~     hypothesize that there will be at least a 50% reduction in VAS scores at 4 hours after~     performing the sphenopalatine block as compared to baseline VAS scores.~   "
13837|NCT03385759|"~     This study is a prospective, randomized trial to compare patient outcomes of unicompartmental~     knee arthroplasty (UKA) and total knee arthroplasty (TKA) for the treatment of medial~     compartment osteoarthritis.~   "
13838|NCT03385746|"~     The trial is done in order to reinforce polyamide to improve its modulus of elasticity to be~     able to use it as a denture base material in all clinical cases~   "
13839|NCT03385733|"~     The aim of this study is to investigate the effective of inspiratory muscle training on~     respiratory function, exercise capacity, physical activity and quality of life.~   "
13840|NCT03385720|"~     Trial design: a randomized controlled trial.~      Eligibility criteria for participants: patients with primary early stage oral squamous cell~     carcinoma. Exclusion criteria: cancer of the floor of the mouth.~      Interventions: submandibular gland is preserved during neck dissection for patients of the~     experimental group; submandibular gland is removed during neck dissection for patients of the~     control group.~      Primary Parameters: survival rate, mortality rate~   "
13841|NCT03385707|"~     This study is designed to evaluate individuals who are currently experiencing symptoms of~     hypoglycemia, in order to discern correlations between microbiome composition and patterns of~     postprandial glycemia.~   "
13842|NCT03385694|"~     Rotationplasty is a very special surgical technique. In its most frequent variant it allows,~     in the bone sarcomas of the distal femur, to remove all the thigh tissues including the knee~     joint keeping intact the innervation of the leg and the foot that are transplanted proximally~     after a 180 ° rotation and joined to the proximal femoral stump.~      It is currently the first choice in children under the age of 6 with a bone sarcoma localized~     to the distal femur but also finds indication in all age groups in cases of extremely~     voluminous and extended to the entire thigh with the oncological need to remove in block~     femur, knee and all the muscular involved. The objective of the study is to obtain~     information about the clinical and functional status of the limb operated in long-term~     surviving patients. In particular in this study the problem of the possible degenerative~     pathology of the hip on the operated side will be addressed. Moreover the psychic and~     psychological well-being of this population with particular reference to gender and~     motherhood will be tested.~   "
13867|NCT03385369|"~     This is a phase I, randomized, blinded study to evaluate the safety and pharmacokinetics of~     MEDI0382 following single dose administration to overweight/obese subjects of Japanese or~     Chinese descent~   "
13843|NCT03385681|"~     This study will explore nurses' pediatric postoperative pain management knowledge and~     clinical practices. The aim is to evaluate if a tailored educational intervention will~     improve nurses' knowledge and attitudes of pain management and pain management practices. The~     intervention offered is education and skills training. The study has a pre-post design and a~     comparison group. Data is collected before the intervention is started (baseline T1) and~     again one month (T2) and six months (T3) after the intervention. Nurses working in six~     postoperative units are participating. The units are the largest pediatric postoperative~     units of each of the six university hospitals covering all health regions in Norway. Three~     different approaches will be used to collect data (survey with questionnaire, observations of~     clinical practice, and interviews with children).~   "
13844|NCT03385668|"~     The purpose of this study is to determine wether pirfenidone is safe and effective in the~     treatment of pulmonary fibrosis with anti-myeloperoxydase (MPO) antibodies or pulmonary~     fibrosis with anti-MPO associated vasculitis.~   "
13845|NCT03385655|"~     The purpose of the pre-study screening is to test for DNA abnormalities or biomarkers.~   "
13846|NCT03385642|"~     To investigate the long-term efficacy and safety of the medical device, ChondroMimetic, in~     subjects who were treated in the interventional study 0MCM0107 for osteochondral defects of~     the knee.~   "
13847|NCT03385629|"~     The study is a multi-site, multi-level, and multi-component cluster randomized clinical trial~     (RCT) to address poor dental utilization (attendance) and untreated caries among 3-6 year old~     Medicaid-enrolled children attending well-child visits (WCV) in primary care settings. The~     focus is on addressing factors (determinants) at the socio-ecological levels of the child's~     environment: provider (pediatrician and nurse practitioner), practice/organization level, and~     parent/caregiver level. Eighteen practices will be randomized to 2 arms: A) bundled~     multi-level intervention consisting of: 1. training medical providers in the Common-Sense~     Model of Self-Regulation theory-based education so that the provider delivers to the~     parent/caregiver the following: i) Core oral health facts about dental caries, and ii)~     prescription to visit the dentist and a list of dentists accepting Medicaid; 2. Integration~     of oral health assessments into EMR for the provider to document in the child's medical~     record; versus B) Control arm of medical providers receiving the American Academy of~     Pediatrics (AAP) based oral health education and providing usual AAP-based care for oral~     health. Each arm will consist of 9 practices. Children will be followed for 24 months to~     determine dental utilization and changes in oral health status.~      The primary aim is to examine the effectiveness of theory-based behavioral (provider-level)~     and implementation (practice-level) bundled interventions versus enhanced usual care (AAP~     based oral health education) delivered by providers at WCVs in increasing dental attendance~     among 3-6 year old Medicaid-enrolled children. The secondary aims are to 1) assess the~     effectiveness of interventions on secondary outcomes (e.g. development of new caries, changes~     in oral hygiene, oral health quality of life, frequency of sweet snacks and beverages, cost),~     2) assess potential mediators and moderators to investigate the pathways through which the~     multi-level interventions affect child primary and secondary outcomes, and 3) assess the~     adoption, reach, fidelity, and maintenance of providers and practices that affect child~     primary and secondary outcomes.~      The hypothesis is that theory-based behavioral (provider-level) and implementation~     (practice-level) bundled interventions delivered by providers at WCVs will increase dental~     attendance among 3-6 year old Medicaid-enrolled children versus enhanced usual care (AAP~     based oral health education) delivered by providers at WCVs.~   "
13848|NCT03385616|"~     Feasibility trial (FIH) to assess the safety and clinical utility in patients with chronic~     bronchitis in Canada.~   "
13849|NCT03385603|"~     The purpose of this study is the evaluate the extent to which an intervention aimed at~     reducing pain-related fear affects sexual function and pain sensitivity compared to usual~     care.~   "
13850|NCT03385590|"~     The purpose of this intervention study is to assess the feasibility and acceptability of~     soy-fiber-maize versus soy-maize complementary foods on bowel movement frequency, transit~     time, growth, gastrointestinal symptoms, microbiota composition and activity.~   "
13851|NCT03385577|"~     This study will test the feasibility and acceptability of a yoga program for women with~     gynecologic malignancies such as ovarian, endometrial, or cervical cancer. This study will~     pilot an integrative yoga intervention that combines Western psychotherapeutic approaches~     with classic yogic philosophy to reduce emotional distress among women undergoing treatment~     for gynecologic cancer and provide a comprehensive approach to stress management across the~     cancer care continuum.~   "
13852|NCT03385564|"~     The main objectives of this trial are to evaluate the long term efficacy and safety of~     different doses of BI 655064 versus placebo as add-on therapy to Standard of Care (SOC)~     during maintenance therapy for lupus nephritis.~   "
13853|NCT03385551|"~     This is a study to evaluate the acceptability, efficacy and preferences of 10 of estradiol~     vaginal tablets vs promestriene vaginal cream~   "
13854|NCT03385538|"~     Personalized therapy as prophylaxis in ischemic stroke patients is not yet an option. From~     patients with ischemic heart disease, we know that patients with in vitro high on treatment~     platelet reactivity (HTPR) have an increased risk of stent thrombosis following per-cutaneous~     coronary intervention. Other studies have shown association of CYP2C19 genotypes with~     different responses to the anti platelet drug Clopidogrel. We measure HTPR in ischemic stroke~     patients on increasing doses of clopidogrel and investigate the CYP2C19 genotype for each~     patient.~   "
13855|NCT03385525|"~     The primary objective of this study is to evaluate the effect of multiple doses of the UGT~     inhibitor valproic acid on the single-dose pharmacokinetics of BIIB074. The secondary~     objectives of this study are to evaluate the safety and tolerability of BIIB074 when~     administered alone and when coadministered with the UGT inhibitor valproic acid and to~     evaluate the effect of the UGT inhibitor valproic acid on the PK of the M13, M14, and M16~     metabolites of BIIB074.~   "
13856|NCT03385512|"~     This large scale multi-center cluster randomized controlled trial (RCT) is designed to assess~     the comparative effectiveness of three interventions in diverse ambulatory care settings and~     patient populations. Findings will help healthcare systems decide which approach to adopt to~     empower patients and enable providers to engage in patient centered communication. The~     specific aims are to:~        1. Engage with patients and healthcare providers who have used the tools in the pilot study~          (ClinicalTrials.gov Identifier NCT02522286) at the Sutter Health Palo Alto Medical~          Foundation (PAMF), as well as new stakeholders at University of California San Diego~          Health System and Meyers Primary Care Institute at University of Massachusetts and~          Reliant Medical Group, to further refine and adapt these patient-centered interventions~          to be integrated into real world primary care clinics.~        2. Conduct a large scale cluster RCT with three arms, to evaluate the comparative~          effectiveness of three interventions: OPEN with in-person SPI training (High Touch),~          OPEN with online SPI training (High Tech), and ASK. Primary outcomes will include~          patient perceptions of how well their PCPs have engaged them in patient centered~          communication. The investigators will also measure patients' confidence in managing~          their health, intention to follow through with care plans, and downstream behaviors in~          following through with care plans, use of services such as phone calls, secure~          messaging, and additional visits.~        3. Identify the strategy that has the most potential for sustained impact and replication~          within and across healthcare systems. The investigators will analyze the fidelity to the~          intervention protocols, including consistency of delivery as intended and the~          time/effort involved in implementing the interventions. The investigators will also~          assess the extent to which the programs become institutionalized.~      The investigators anticipate that this multi-level healthcare system intervention will result~     in significant improvement in: patient satisfaction with how PCP has engaged them in the~     visit, confidence in selfcare; patients' intention to adhere to care plan, and clinical~     indicators. Furthermore, more effective communication would lower health service utilization~     after the visit. The investigators further expect that the intervention will affect~     physicians', medical assistants' and nurses' experience as well as healthcare system leaders'~     intention to implement in routine practice.~   "
13857|NCT03385499|"~     Caused by Toxoplasma gondii, toxoplasmosis is mostly asymptomatic except in immunocompromised~     individuals and infants infected in utero. Congenital toxoplasmosis (CT) results from the~     transplacental passage of the parasite, which occurs in 30% of cases of primary infection~     during pregnancy. Neonatal biological diagnosis of toxoplasmosis is essential in the case of~     (i) suggestive clinical signs in the newborn with no information on the serological status of~     the mother, (ii) seroconversion diagnosed during pregnancy, (iii) not or poorly followed~     pregnancy, and (iiii) for enhanced effectiveness of treatments administered as soon as~     possible to the newborn. Given the limitations of current diagnostic tests, the~     characterization of specific immunoglobulin (Ig)G neo-synthesized by the newborn would be of~     great help for an early diagnosis of CT.~      The main objective of the TOXODIAG project is to validate and evaluate the ELISPOT~     (Enzyme-Linked Immunosorbent SPOT assay) method for detecting, in the newborn, B lymphocytes~     (LyB) sensitized in utero to produce T. gondii specific immunoglobulins (Ig) following a~     primary infection of the mother during the pregnancy. More precisely, the detection and~     quantification of LyB secreting IgG and IgM specific for T. gondii using the ELISPOT method~     will be applied i) to mononuclear cells of women in seroconversion following a toxoplasmic~     primo-infection during pregnancy and ii) to cord blood mononuclear cells of newborns~     suspected of CT, in comparison to positive and negative infection controls.~      To reach this goal, TOXODIAG is a diagnostic, multicentric, prospective, non-randomized,~     comparative and controlled study. It will be performed in 3 parallel groups of pregnant women~     performing prenatal follow-up and giving birth in the maternity wards of 3 hospitals of the~     AP-HP (Louis MOURIER, Bichat-Claude Bernard and Cochin) which ensure mother/child follow-up~     and biological sampling, with great gynecology and obstetrics expertise. Sixty women will be~     selected and included into 3 groups according to toxoplasmic seroconversion during pregnancy~     (n=30), positive (n=15) or negative (n=15) toxoplasma serology. The necessary biological~     material will consist in additional blood tubes which will be taken at the same time as those~     performed for the usual pregnancy follow-up examinations and will correspond to maternal~     peripheral blood at inclusion, seroconversion and delivery as well as cord blood.~   "
13858|NCT03385486|"~     This is a study of transfusion of TBX-3400 in patients with stage III and IV melanoma~     resistant or refractory to Immune Checkpoint Inhibitors.~      The patient's own blood cells are exposed to a protein that has been shown in the laboratory~     to result in anti-tumor activity.~      The study hypothesis is that TBX-3400 cells will enhance anti-tumor activity and improve the~     body's immune response.~   "
13859|NCT03385473|"~     The efficacy and safety of antiretroviral therapy and the damage caused by chronic~     inflammation in the presence of the virus has recently lead to the consideration of~     initiating antiretroviral therapy earlier than what is required to prevent opportunistic~     diseases.~      Although there may be subtle differences, all recommended antiretroviral combinations for~     first-line therapy are considered equally effective. Nevertheless, treatment success requires~     high levels of adherence, which is linked to tolerability and the minimization of adverse~     effects.~      The genes coding the enzymes that are involved in the antiretroviral clearance pathways and~     the transmembrane transport of drugs are known. These genetic variations can determine the~     interindividual variations in plasma concentration with the same doses. Both pharmacogenomics~     (PG) and therapeutic drug monitoring (TDM) may contribute to the individualization of therapy~     in different chronic conditions through dosing optimization and are associated with a lower~     risk of concentration-dependent toxicity and potentially greater efficacy. The use of these~     strategies in the context of antiretroviral therapy is in early stage of development.~      Following, our main hypothesis is that PG + TDM dose adjustment of efavirenz or atazanavir in~     the initial antiretroviral treatment of naive patients with HIV infection is non-inferior in~     terms of efficacy, has improved safety, and shows a better cost/effectiveness profile than~     the standard approach with non adjusted doses.~      To evaluate our hypothesis we developed this multicenter randomized clinical trial, where~     patients from 4 clinical sites in Buenos Aires will be included in the protocol and~     randomized to standard of care (SOC) or pharmacological adaptation (PA) -PA: PG + TDM. For~     the pharmacogenomics determination, we developed a multiplex approach including main~     polymorphisms of CYP2B6, CYP2A6, CYP3A4 y ABCB1 for efavirenz; and UGT1A1, ABCB1 and CYP3A4~     for atazanavir. Drug plasma levels will be analyzed with ultra-performance liquid~     chromatography (UPLC).~      The main outcomes are to establish the usefulness of PG and TDM in determining the efficacy,~     safety and cost/effectiveness of a first-line antiretroviral therapy containing either~     efavirenz or atazanavir in patients with HIV infection who have not received prior~     antiretroviral therapy.~   "
13860|NCT03385460|"~     We hypothesize that LESWs might temporarily increase urothelial permeability and facilitate~     delivery of intravesical botulinum toxin without the need for injection.~   "
13861|NCT03385447|"~     This study focuses on analyzing the data collected from participants in the Faculty/Staff~     Exercise Program to determine the success and quantifying the results of the program. The~     investigators are interested in the effectiveness of this program on multiple levels,~     individual and group, as it is the first of its kind - an exercise program targeting the~     faculty and staff at a university.~   "
13862|NCT03385434|"~     Screening colonoscopy for colorectal cancer is essential to diagnose and remove adenomas,~     precancerous stages of colorectal cancer. Unfortunately approximately 25 % of all adenomas~     are missed during the examination. Recently a new colonoscopy accessory, the Endorings-2~     (EndoAid Ltd., Casearea, Israel), has been designed to improved the detection of adenomas~     during colonoscopy (adenoma detection rate).~      Endorings-2 is a silicone-rubber device that is fitted on the colonoscope and is equipped~     with circular flexible silicon rings mechanically stretching the colonic folds during~     withdrawal.~      This study aims to evaluate the efficacy of Endorings-2 to improve the adenoma detection rate~     in a prospective, blinded clinical trial. 292 patients with an indication for a screening~     colonoscopy shall be included (1:1 randomization in standard colonoscopy versus~     Endorings-2-assisted colonoscopy).~   "
13863|NCT03385421|"~     The Nutritional Practices and Outcomes in Non-Invasive Ventilation (NPO/NIV) study is a~     collaboration with lead sites from pediatric critical care units within US and Canada, and~     participating sites from multiple international regions. The goal of NPO/NIV is to understand~     how non-invasive ventilation (NIV) is used to treat critically ill children and,~     concurrently, how these children are fed while on NIV. Designed as a period prevalence study,~     NPO/NIV will collect observational, cross-sectional data over the course of five study weeks.~     Each study week will require two days of screening for eligible patients. On Mondays, study~     staff will screen for patients eligible in the previous 48 hours. On Tuesdays, study staff~     will screen for patients eligible in the previous 24 hours. Patients meeting study inclusion~     will be eligible to complete V0, V1, and V2. Included patients will be followed for 7 days~     after the initiation of NIV or until the patient is discharged from the pediatric intensive~     care unit. This study was granted exempt status by the University of Arizona Human Subjects~     Protection Program, including a waiver of informed consent. As no personal health information~     is transmitted during the course of the study, the University of Arizona does not require~     Data Use Agreements between sites to participate.~   "
13864|NCT03385408|"~     This study will determine the efficacy of High Intensity Laser Therapy (HILT) for the~     treatment of shoulder osteoarthritis.~   "
13865|NCT03385395|"~     This randomized trial is being conducted to show non-inferiority of OctaAlpha1 compared to~     Glassia® in terms of the serum trough levels at steady state. This will be conducted in~     individuals with alpha-1-antitrypsin deficiency and clinical evidence of emphysema.~   "
13866|NCT03385382|"~     Between December 2016 and June 2017 a total of 40 eyes from 40 diabetic retinopathy patients~     with diabetic macular edema were recruited at the Ophthalmologic Clinic of University G.~     d'Annunzio, Chieti-Pescara, Italy.~   "
14076|NCT03382639|"~     The purpose of this study is to determine whether add-on TAK-831 is superior to placebo on~     the Positive and Negative Syndrome Scale Negative Symptom Factor Score (PANSS NSFS).~   "
13868|NCT03385356|"~     Vitamin D is important risk factor for developing multiple sclerosis (MS) and for disease~     progression. Patients with MS who had lower vitamin D levels were at increased risk for more~     clinical attacks and faster disease progression. It was also shown that patients with MS had~     lower vitamin D levels in serum than healthy controls. It is not clearly defined, which are~     the levels of vitamin D in serum, that are high enough to trigger immunomodulatory effect and~     are safe for patients.~      This double-blind randomized clinical trial was designed to compare impact of vitamin D~     supplementation in two different doses (1000 IU/day vs 4000 IU/day) in patients with~     relapsing remitting MS. The main goal of this trial is to compare dose response on vitamin D~     supplementation and to estimate more closely appropriate level of vitamin D in serum which~     triggers some of experimentally shown immunomodulatory actions.~   "
13869|NCT03385343|"~     This study is being done to see if the NvisionVLE Imaging System can accurately determine the~     diagnostic performance of staging of T1 esophageal adenocarcinoma.~   "
13870|NCT03385330|"~     Bronchopulmonary dysplasia (BPD), or chronic lung disease of prematurity, affects nearly half~     of extremely preterm infants.This study evaluates the use of supplemental oxygen to manage~     infants with established BPD. Participants will be randomly placed in either a higher oxygen~     saturation group or a lower oxygen saturation target group.~   "
13871|NCT03385317|"~     People with COPD have a greater risk for symptoms of depression, anxiety, and fear of~     breathlessness. Those emotions are independently associated with lower physical activity,~     poorer quality of life, and higher hospitalization and exacerbations; all independent~     predictors of survival and costs. There is a lack of treatment options to be routinely used~     in primary clinics for patients with COPD. Systematic reviews suggest that interventions that~     promote an accepting mode of response, such as mindfulness, might be more appropriate and~     effective for managing psychological distress in COPD patients, especially breathing-related~     anxiety.~      Hypothesis: A home-based 8-week Mindfulness-Based Stress Reduction (MBSR) for COPD targeted~     to individuals with symptoms of depression, anxiety, or fear of breathlessness delivered by a~     mindfulness coach using a combination of in-person sessions and remote video call sessions~     will be effective in improving emotional and overall quality of life, and measured physical~     activity.~   "
13872|NCT03385304|"~     The prevention of infection is the single most important goal influencing peri-operative care~     of patients with open fractures. Standard practice in the management of open fractures~     includes sterile technique and pre-operative skin preparation with an antiseptic solution.~     The available solutions kill bacteria and decrease the quantity of native skin flora, thereby~     decreasing surgical site infection (SSI). While there is extensive guidance on specific~     procedures for prophylactic antibiotic use and standards for sterile technique, the evidence~     regarding the choice of antiseptic skin preparation solution is very limited for open~     fracture surgery.~   "
13873|NCT03385291|"~     In recent years, promoting wakening attempts in patients with disorders of consciousness are~     increasing, but there are a lack of objective indicators to evaluate the efficacy and further~     researches on the brain mechanism during the wakening processing. So, the study first~     assessed the cerebral response during emotional acoustic stimuli with quantitative EEG and~     ERP(Event-related potential), and next, the investigators explored the relationship between~     brain activation and patients' recovery.~   "
13874|NCT03385278|"~     Transcranial magnetic stimulation involves the use of alternating magnetic fields to~     stimulate neurons in the brain.To date, several studies have focused on the use of TMS in~     patients with impaired consciousness.However,its therapeutic effects have been variously~     documented.So,in this study ,investigators explore the effects of rTMS with cross-over~     design.~   "
13875|NCT03385265|"~     The purpose of this research is to develop DIPPer Academy, a family-focused, mobile health~     (mHealth) behavioral intervention to promote glycemic control and type 1 diabetes (T1D)~     adherence in young children.~   "
13876|NCT03385252|"~     The Mazira Project is a study of the effect of egg consumption on growth, development and gut~     health of infants in Malawi. The study randomly assigns infants to receive one egg per day~     over six months or to receive an equivalent value of food at the end of six months. Growth,~     achievement of developmental milestones, gut microbiome composition and other measures of~     nutritional status are compared between the two groups to determine whether regular egg~     consumption benefits Malawian infants.~   "
13877|NCT03385239|"~     This is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to~     evaluate the safety, including tolerability, of ISIS 678354 and to assess the efficacy of~     different doses and dosing regimens of ISIS 678354 for reduction of serum triglyceride (TG)~     levels in patients with hypertriglyceridemia and established CVD.~   "
13878|NCT03385226|"~     Trial Subjects (patients), will receive single infusions of pembrolizumab every 3 weeks until~     disease progression or unacceptable toxicity develops. They will receive radiotherapy at week~     12.~   "
13879|NCT03385213|"~     Colonic microbiome has been found to contribute to the development of colorectal cancer. We~     speculate that gut microbiota related to colorectal cancer relapse after curative treatment.~     This study aim to discover if any difference of gut microbiota exist in patients who suffer~     from cancer relapse compared with patients who do not. Finally develop patient-centred~     programmes of surveillance protocols base on microbiota analysis.~   "
13880|NCT03385200|"~     Effect of the contrast-enhanced diagnostic ultrasound during neoadjuvant chemotherapy of~     breast cancer on the achieved tumor size reduction and tolerability of chemotherapy~   "
13881|NCT03385187|"~     Prospective validation study of the NightOwl, a Type IV home sleep apnea test (HSAT),~     compared to a traditional Type I and a Type IV sleep monitor.~   "
13882|NCT03385174|"~     Studying Carbon monoxide effects on brain vessels in healthy volunteers with magnetic~     resonance imaging.~   "
13883|NCT03385161|"~     To compare safely and efficacy of intraprostatic injection of botulinum toxin A versus~     ethanol for treatment of benign prostatic hyperplasia (BPH).~   "
13884|NCT03385148|"~     The protein tyrosine kinase-7 (PTK7) is overexpressed in various types of human cancers. As a~     specific imaging agent of PTK7, 68Ga-Sgc8 was investigated in this study to assess its~     safety, biodistribution and dosimetric properties in healthy volunteers, and to preliminarily~     evaluate its application in colorectal patients.~   "
13886|NCT03385122|"~     Environmental factors constitute an important but underappreciated risk factor towards the~     development and progression of cardiovascular disease (CVD). Environmental exposure in~     variable pollutants is implicated in the derangement or propagation of adverse~     pathophysiological processes linked with atherosclerosis, including genetic, hemodynamic,~     metabolic, oxidative and inflammation parameters. However no data exists concerning~     environmental pollution in rural or semi-rural areas. Therefore the purpose of the~     Corinthia study is to examine the impact of environmental pollution in indices of~     cardiovascular morbidity and mortality in a cross-sectional and longitudinal design.~     Corinthia study began in October 2015 and is planned to recruit 2400 individuals from~     different regions of Corinthia country with different environmental exposure to pollutants~     and different patterns of soil-ground and/or air pollution until September 2018. Baseline~     measurements will include lifestyle measurements, anthropometric characteristics and a~     comprehensive cardiovascular examination. The follow-up is planned to extent, prospectively,~     up to 10 years and this study is anticipated to provide valuable data on the distinct impact~     of soil and air pollution in early markers of atherosclerosis and cardiovascular disease and~     in the overall impact of environment pollution to cardiovascular morbidity and mortality.~   "
13887|NCT03385109|"~     An open label observational registry trial in which participating centers enroll subjects who~     had or will have a laparoscopically assisted surgery using the Senhance Surgical System.~   "
13888|NCT03385096|"~     The purpose of this study is to evaluate the safety and efficacy of Melphalan and BUCY+VP-16~     myeloablative conditioning regimens in multiple myeloma undergoing autologous hematopoietic~     stem cell transplantation.~   "
13889|NCT03385083|"~     This is a randomized controlled study to assess the effects of activity monitors, with~     telehealth follow ups, on the treatment of chronic low back pain subjects.~   "
13890|NCT03385070|"~     Salt-sensitive hypertension (SSH) accounts for about the half of all Hypertension (HT) cases~     .In SSH, Na+/K+-ATPase activity is impaired. Impaired Na+/K+-ATPase activity in the lens~     epithelium results in cortical opacities in the peripheral equator of the lens.~      This study analyzed 305 patients with hypertension aged between 40 and 80 years and 124~     non-HT controls. A total of 163 patients with HT who were admitted to the emergency service~     at least once with a minimum increase of 10% in their systolic and diastolic blood pressure~     after consuming salted food met the eligible criteria for HT and were included in the SSH~     group. A total of 142 patients who were previously diagnosed with HT but had no previous~     history were considered non-SSH. Two researchers examined the presence of cortical lens~     opacities biomicroscopically using the diffuse, direct, Scheimpflug, and retroillumination~     from fundus methods.~   "
13891|NCT03385057|"~     Pediatric tonsillectomy is one of the most common surgical procedures annually in the United~     States; risks include postoperative hemorrhage and poor pain control. Controversy exists~     regarding optimal pharmacologic pain management following surgery, as each drug's efficacy is~     balanced by its specific side effects. Ibuprofen is effective in controlling postoperative~     pain following tonsillectomy, but its mechanism of action results in decreased platelet~     function, which may increase postoperative bleeding events. This is a multicenter, randomized~     control non-inferiority trial designed to assess the relationship between short-course~     ibuprofen use and post-tonsillectomy bleeding when compared to acetaminophen.~   "
13892|NCT03385044|"~     The endotracheal intracuff pressure is to be maintained at a low level to prevent trachea and~     nerve damages, and yet be high enough to secure air sealing. The objective of the study is to~     compare minimal occlusive volume technique (MOVT) and expired volume/inspired volume ratio~     (VE/VI ratio) from a spirometer method of endotracheal tube (ETT) cuff inflation with respect~     to the cuff pressure required to seal the airway during a laparoscopic surgery under general~     anesthesia. A study design is a randomized crossover trial in 35 patients. The primary~     outcome is the intracuff pressure of an endotracheal tube. The study consists of two cuff~     sealing methods separated by a period of 10 minutes.~   "
13893|NCT03385031|"~     In a retrospective study the investigators defined quantitative action levels based on dose~     and volume measures for adaptive radiation therapy in breast cancer patients (Zegers et al.~     Acta Oncol 2017). The aim of this study is to validate these parameters in a prospective~     study.~   "
13894|NCT03385018|"~     Although Laparoscopic gastrectomy for both early and locally advanced gastric cancer has~     gained popularity, the use of laparoscopic total gastrectomy for proximal advanced gastric~     cancer is still limited to some experienced surgeons, because of its technical difficulties~     in D2 lymph node dissection and anastomoses.~      Some retrospective and cohort studies regarding laparoscopic total gastrectomy with lymph~     node dissection suggested the likelihood of application of laparoscopic surgery for proximal~     gastric cancer. However, there has been no randomized clinical trial comparing results of~     laparoscopic total gastrectomy with D2 lymph node dissection with open conventional surgery.~      Therefore, we aimed to verify the efficacy of laparoscopic total gastrectomy with D2(D2-10)~     lymph node dissection, technical and oncologic safety compared with open surgery via~     multicenter randomized clinical trial.~   "
13895|NCT03385005|"~     The specific aim of this study is to evoke functional movement in the hand of both healthy~     individuals and individuals diagnosed with a complete (AIS A) C5 level spinal cord injury.~     The primary purpose of this study is to determine the feasibility of achieving refined hand~     movements through electrical stimulation of the muscles within the forearm. It is believed~     that this study will be able to identify specific stimulation parameters and electrode~     spatial configurations responsible for various refined hand movements.~      After an eligible individual agrees to participate in this study, s/he will receive~     transcutaneous electrical stimulation on the forearm in order to evoke different hand and~     finger movements. The precision, specificity, and extent of these movements will be visually~     assessed. In order to better evaluate these movements, participants may also be asked to~     perform various functional tasks with their hand. The grip strength and evoked forces at the~     fingertips will also be measured using sensors. There will be up to 4 study sessions each~     week for up to 8 weeks, with each session lasting up to 4 hours. Upon completion of these~     study sessions, the individual's participation in the study is considered complete.~   "
16606|NCT03349593|"~     Prevalence of biventricular function of the heart and preoperative level of venous return is~     not known in non-cardiac non-morbid obese population.~      The aim of the study is to assess the preoperative function of the heart and status of~     hypovolemia on the day of surgery.~   "
13896|NCT03384992|"~     The FoRtitude trial aims to evaluate an eHealth intervention designed to teach breast cancer~     survivors strategies to manage anxiety about cancer recurrence. The eHealth intervention~     includes educational content and interactive tools, designed to teach coping strategies~     and/or inert content, depending on the study participant's randomization assignment. The~     FoRtitude study will examine whether three coping strategies (relaxation training, cognitive~     restructuring, worry practice) are more effective than general health-related content in~     reducing fear of cancer recurrence.~   "
13897|NCT03384979|"~     This study evaluates the different enhancement using a contrast agent dose in computed~     tomography based on total body weight or based on lean body weight. Half of participants will~     receive contrast agent dose based on their total body weight, while the other half will~     receive a dose based on their lean body weight. Our hypothesis is that if contrast agent is~     administered not basing on total body weight but on lean body weight it is possible to obtain~     equal or better quality of enhanced images, a reduction of the variability of contrast~     enhancement, and also a dose reduction in some patients (overweight ones).~   "
13898|NCT03384966|"~     The goal of this study is to find out if a drug called ACT-246475 can prevent platelets from~     binding together when administered by an injection under the skin in the thigh or in the~     belly. Another goal is to know how fast and for how long ACT-246475 works and if there is a~     difference if the drug is injected in the thigh or in the belly. This study will also help to~     find out more about the safety of this new drug.~   "
13899|NCT03384953|"~     The Osher Center for Integrative Medicine (OCIM) at Vanderbilt is a multidisciplinary~     outpatient clinic treating patients with chronic pain and complex health issues via~     integrative services, with goals of improving overall health and wellbeing of those served.~     At OCIM, clinical hypnosis has been historically provided on an individual basis by the~     investigator. Due to its impact and increased patient demand for this service, the~     investigator will be conducting group hypnosis services in addition to individual services~     order to expand the reach of this program to participants. As such, the investigators see~     this as a tremendous opportunity to contribute to clinical research to contribute to the~     evidence based for this form of service by examining participant-reported outcomes associated~     with completing the treatment. For this project, the investigators seek to assess the impact~     of a manualized group treatment protocol utilizing clinical hypnosis as a treatment for~     chronic pain. The investigators will be evaluating participant-reported outcomes to assess~     the 1) feasibility of conducting hypnosis in this setting 2) impact of group hypnosis on pain~     and 3) how participants' responsiveness to hypnosis impacts treatment outcome.~   "
13900|NCT03384940|"~     The main objective of this study is to test the safety and effectiveness of DS-8201a for~     participants with HER2-expressing advanced colorectal cancer.~   "
13901|NCT03384927|"~     1. Assessing whether the treatment diary can help optimize the overall treatment of~          patients.~        2. To assess whether the patient finds the treatment diary useful and worth spending time~          on. Also if the patient finds it easier to evaluate the treatment and, if necessary, set~          new goals.~        3. To assess whether the patient's quality of life is increased by the use of the treatment~          diary.~   "
13902|NCT03384914|"~     The main purpose of this study is to evaluate the safety of each study vaccine and to~     evaluate the effect on the time to disease recurrence (assessed by disease free survival).~      Participants will be assigned to receive one of two study vaccines (DC1 study vaccine vs.~     WOKVAC). The study vaccine will be administered in two phases: a study vaccination phase and~     a booster phase.~   "
13903|NCT03384901|"~     This study will be a retrospective analysis of vitrectomy results in patients suffering from~     diabetic macular edema.~   "
13904|NCT03384888|"~     NeuroFibro is a double-blind, randomized, placebo-controlled clinical trial, using~     neurostimulation in women with fibromyalgia.~   "
13905|NCT03384875|"~     Prospective, multi-center, randomized, blinded, pivotal clinical study. Subjects will be~     randomized in a 1:1 ratio to either standard of care (SOC) alone or standard of care plus~     treatment with the CytoSorb® device.~   "
13906|NCT03384862|"~     While reducing arsenic (As) exposure in Bangladesh and the U.S. must continue to be a top~     priority, this has proven difficult. After decades of mitigation efforts, 42 million people~     in Bangladesh remain exposed to As above 10 μg/L, the World Health Organization guideline for~     arsenic in drinking water. The risk for arsenic-induced health outcomes persists decades~     after exposure has been reduced. Innovative strategies that lower arsenic exposure and~     contribute to mitigating the health effects of arsenic are needed. The main goals of this~     study are to evaluate whether supplementation with folate and vitamin B12 to 8 to 10 year old~     children, in conjunction with reduction in arsenic exposure, can increase arsenic methylation~     and lower blood arsenic and blood monomethyl arsenic (as previously observed in adults). The~     investigators will also explore whether folate and B12 can mitigate arsenic-related~     decrements in cognitive abilities.~   "
13907|NCT03384849|"~     This study is to determine the possibility of assessing the level of anxiety in MRI patients~     by means of the respiration rate (RR) and heart rate (HR) indicators acquired by a~     fiber-optic sensor system. The mean RR and/or HR values recorded at the beginning and the end~     of an MRI scanning will be referred to the State Trait Anxiety Inventory (STAI) scores~     completed before and after the MRI scanning, respectively.~   "
13908|NCT03384836|"~     This phase Ib/II trial studies the side effects and best dose of propranolol hydrochloride~     when given together with pembrolizumab and how well they work in treating patients with stage~     IIIC-IV melanoma that cannot be removed by surgery. Pembrolizumab is a monoclonal antibody~     that ?takes the brakes off the immune system? and thus allows for anti-tumor immune~     responses. Propranolol hydrochloride is a beta adrenergic blocking agent that can enhance~     immune cell responses when under stress. Giving propranolol hydrochloride and pembrolizumab~     may work better in treating patients with melanoma.~   "
13909|NCT03384823|"~     This randomized, double-blind, placebo-controlled study will assess the safety, tolerability,~     and pharmacokinetics of single and multiple orally administered doses of EDP-938 in healthy~     adult subjects~   "
13910|NCT03384810|"~     Define the frequency and survival pattern of cardiac arrests in relation to the hospital day~     of event and etiology of arrest.~   "
16607|NCT03349580|"~     To analyze safety and the effects of early initiation of the rehabilitation. Including the~     objective measurement outcomes after lumbar spine fusion, based on the principles of strength~     training.~   "
13911|NCT03384797|"~     Currently, there are no cures or disease modifying therapies for Parkinson's disease (PD).~     This is partially due to the inability to detect the disease before it has progressed to a~     stage where there are clinical manifestations. The identification and validation of high~     throughput biomarkers to measure disease progression (as well as identify pre-clinical~     disease onset) is critical to the development of disease-modifying or even preventative~     therapies. In this study, we are testing a blood biomarker for PD. Several detection~     parameters will be assessed through enrollment of healthy volunteers over 50 years of age to~     learn more about the analytical process and biological variability.~   "
13912|NCT03384784|"~     This study tests whether galantamine (GAL) reduces HIV-related inflammation and cognitive~     deficits. In this double-blind placebo-controlled crossover study, HIV-infected individuals~     (N=120; 60 smokers and 60 non-smokers) will be randomized to 12 weeks of GAL or placebo,~     followed by a 4-week washout, then 12 weeks of GAL or placebo (arms switched). Outcomes are~     monocyte/macrophage and T cell activation and neurocognitive performance.~   "
13913|NCT03384771|"~     Objectives. The primary objective of the current proposal is to identify teacher-related~     factors that can be feasibly measured and shown to predict mindfulness-based intervention~     (MBI) participant outcomes. The secondary objective of this R34 proposal is to lay the~     groundwork for a large-scale R01-funded study in which the investigators anticipate studying~     participants in Mindfulness-Based Stress reduction (MBSR) courses provided by 50 or more~     teachers in a range of university- and community-based settings.~   "
13914|NCT03384758|"~     Aim of this prospective clinical study is the Evaluation of the Effect of Compression Therapy~     on the Microcirculation in Patients With Leg Edema and Mild to Moderate PAD or Diabetes~     Mellitus.~   "
13915|NCT03384745|"~     This is a multi-center phase 2b study in subjects with moderate to severe chronic plaque-type~     psoriasis. Approximately 300 subjects will be enrolled at approximately 60 investigator sites~     in North America and Europe.~   "
13916|NCT03384732|"~     The sum of medical interventions can do more harm than good. Supporting patients' resources~     instead of combating disease might effectively help reducing too much medicine. A first~     step to approach this goal would be to have a classification tool that captures the essential~     features of a meaningful human life, namely body functions, activities, and participation.~     The International Classification of Functioning, Disability and Health (ICF) is the perfect~     framework to distinguish between necessary and unnecessary medical interventions by offering~     descriptions of outcomes of medical and non-medical interventions. However, though adequate~     and comprehensive in theory, it is impracticable in a primary care setting. Therefore, a core~     set of the ICF for the old and very old in primary care is needed. Four preparatory studies~     according to the international development guideline will be carried out: a systematic~     literature review to capture the research perspective, a qualitative study to assess the~     patients' perspective, an experts' survey and an empirical multicenter study to detect the~     clinical perspective.~   "
13917|NCT03384719|"~     The purpose of PROGRO is to determine which combinations of milk and plant proteins are~     optimal to promote growth factors in children~   "
13918|NCT03384706|"~     The purpose of this research study is to compare the effectiveness of two treatments for the~     symptoms of Posttraumatic Stress Disorder (PTSD) with a no therapy, wait-list control~     condition. The two treatments are Cognitive Processing Therapy (CPT) as compared to~     Accelerated Resolution Therapy (ART). Both have been found to be effective with veterans and~     civilians in prior studies but they have never been compared to one another. Participants~     will be 280 males and females ages 18 and older who meet criteria for PTSD (or subthreshold~     PTSD). PTSD is a condition that can occur after a trauma experience such as combat, sexual~     abuse, physical abuse, or natural disasters.~   "
13919|NCT03384693|"~     Thrombotic microangiopathy (TMA) is a common complication in the stem cell transplant~     population. Certain populations within the hematopoietic stem cell transplant (HSCT)~     population are at a higher risk than others. Defibrotide is an endothelial stabilizing agent~     which may prevent the endothelial damage that triggers TMA in HSCT patients. The feasibility,~     safety, and efficacy of defibrotide prophylaxis in a pediatric transplant population is~     unknown. Twenty five patients age 0 to 30 years receiving autologous or allogeneic~     hematopoeitic stem cell transplant who meet TMA high risk criteria will be enrolled. Patients~     will receive Defibrotide for 28-35 days starting before conditioning, and will be closely~     monitored for any adverse events up through 6 months post-transplant. The feasibility of~     administering defibrotide will be evaluated as well as incidence of TMA.~   "
13920|NCT03384680|"~     This study is conducted to collect the symptoms of lung cancer patients and to observe the~     relationship with proteomics.~   "
13921|NCT03384667|"~     The aim of the present study is to evaluate the efficacy and safety of Maekmoondong-tang on~     post-operative cough in patients with lung cancer. A randomized, double-blind,~     placebo-controlled trial will be conducted.~   "
13922|NCT03384654|"~     The purpose of this study is to evaluate the efficacy of daratumumab in addition to standard~     chemotherapy in relapsed/refractory B-cell acute lymphoblastic leukemia (ALL)/lymphoblastic~     lymphoma (LL) and T-cell ALL/LL as measured by the complete response (CR) rate.~   "
13923|NCT03384641|"~     The purpose of this study is to assess the efficacy of an 8-week bedaquiline monotherapy~     regimen in participants with treatment-naive, multibacillary (MB) leprosy.~   "
13924|NCT03384628|"~     This study will compare the on-eye fitting characteristics of three types of contact lenses.~     Each lens pair will be worn for 30 to 45 minutes before assessment and the results will be~     compared to mathematically calculated fitting characteristics.~   "
13935|NCT03384485|"~     Fabry disease, an X-linked disorder of glycosphingolipids that is caused by mutations of the~     GLA gene that codes for α-galactosidase A, leads to dysfunction of many cell types and~     includes a systemic vasculopathy. As a result, patients have a markedly increased risk of~     developing ischemic stroke, small-fiber peripheral neuropathy, cardiac dysfunction and~     chronic kidney disease. Because this disease is a rare disease most of the time it is~     misdiagnosed, so in this study we will check out the Prevalence of lysosomal hydrolase~     alpha-glagtosidase deficiency ( Fabry disease) in patients with Antiphospholipid Syndrome.~   "
13936|NCT03384472|"~     This study is to determine the prevalence and geographical distribution of antimalarial drug~     resistance-linked genetic mutations in clinical P. falciparum infections in Cambodia~   "
13925|NCT03384615|"~     Prolonged grief disorder (PGD) is a novel diagnostic entity proposed to describe a~     psychiatric disorder that occurs after the loss of a loved one. The disorder is to be~     implemented in The International Classification of Diseases 11th Revision (ICD-11), scheduled~     for release in 2018. Failure to recognize and treat PGD may have negative effects on health,~     functional capacity and quality of life. However, very little is known about the~     characteristics and treatment of PGD in adult Danish populations although such knowledge is~     much needed before introducing the disorder in Danish health services.~      The present study aims to develop, test and disseminate a group-based treatment manual for~     PGD in bereaved partners and their adult children. People with high levels of symptoms will~     be recruited from a large-scale survey study examining frequency, predictors and prognosis of~     PGD symptoms (NCT03049007). Participants will be randomized to group-based compassion-focused~     therapy (CFT) for grief or a waitlist control group. Treatment effects will be estimated with~     prolonged grief symptoms as the primary outcome. Secondary outcomes include depressive~     symptoms, posttraumatic stress symptoms, symptoms of anxiety, and quality-of-life. The~     investigators expect that CFT will yield statistically significant effects on prolonged grief~     symptom compared with the waitlist control group. If CFT is shown to be efficacious in~     reducing prolonged grief symptoms, the investigators will conduct moderation and mediation~     analyses with the aim of identifying what works, for whom. Finally, the investigators will~     perform cost-effectiveness analyses by linking the data with healthcare utilization data from~     the Danish National registries.~   "
13926|NCT03384602|"~     Among the most promising interventions targeting both cognitive and functional decline, is~     Exercise. However, evidence regarding exercise interventions among seniors with cognitive~     impairment are inconclusive, likely due to challenges of recruitment and adherence.~     Alternatively, seniors with subjective cognitive decline (SCD), who are not yet meeting~     objective criteria of cognitive impairment, but have been shown to have twice the conversion~     rate to dementia compared with healthy seniors, are more likely to be motivated to~     participate and adhere to exercise interventions. Thus, exercise interventions in seniors~     with SCD may provide a window of opportunity for early prevention of dementia and falls.~      The investigators aim to test the effect of a group exercise (multi-task Jaques-Dalcroze~     Eurhythmics) and a simple home strength exercise program on change of cognitive function and~     the rate of falling among seniors with SCD.~   "
13927|NCT03384589|"~     This study is assessing if a reduced dosing schedule (1+1) of the 13-valent pneumococcal~     conjugate vaccine (PCV13) is non-inferior to the currently used schedule used in most of~     Canada.The vaccine is currently usually given as 3 doses at 2, 4 and 12 months of age. This~     study aims to find out if it is possible to achieve the same protection using just 2 doses,~     at 2 and 12 months.~   "
13928|NCT03384576|"~     The purpose of this research study is to examine the effects of playing classical music in~     the waiting room on caregiver anxiety. People who enter the study will be asked a few~     identifier questions including age and relation to patient and then will be asked fill out a~     survey regarding anxiety.~   "
13929|NCT03384563|"~     The purpose of this protocol is to determine the effect of two clinically applicable~     Dexmedetomidine dosages (0.5mcg/kg and 1mcg/kg) on the minimum alveolar concentration (MAC)~     of Sevoflurane in children between the age ranges of: 1-6 months; 6-12 months of age and 12~     months-36 months years of age.~   "
13930|NCT03384550|"~     The investigators conduct a micro-randomized trial to test main effects and moderators of~     three different intervention components of Ally, a mHealth intervention to promote physical~     activity that is offered to customers of a large Swiss health insurance. Interventions~     include the use of different incentive strategies, a weekly planning intervention and daily~     message prompts to support self-regulation. The Health Action Process Approach (HAPA) as well~     as principles from behavioral economics were used to guide the development of interventions.~     Further, sensor data is collected in order to enable prediction of latent contextual~     variables. These data can be used to build prediction models for the user's state of~     receptivity, i.e. points in time where the user is able and/or willing to receive, process~     and utilize the support provided. The results of this study enable the evidence-based~     development of a just-in-time adaptive intervention for physical activity.~   "
13931|NCT03384537|"~     The objective of this study is to compare the effect of Tropolone containing mouthwash versus~     CHX 0.2% mouthwash in reducing intraoral microorganism. Randomized clinical trial study~   "
13932|NCT03384524|"~     This phase I/II trial is designed to provide proof of concept evidence that combination~     therapy can have a beneficial effect on DME and possibly prevent increases in retinal volume~     or progression of non-central DME into the central subfield of the macula. If a beneficial~     effect is apparent in this phase I/II study involving a relatively small sample size and~     short follow-up period, its results could be used to in plan future phase III trials. We~     believe this study will be the first to show that a systems pharmacology approach can~     successfully address diabetic macular edema, and thus revolutionize the treatment of complex~     retinal diseases for which there are a paucity of effective treatment options.~   "
13933|NCT03384511|"~     This is an open-label, single arm study to explore whether 18F-ALF-NOTA-PRGD2 PET/CT scan can~     predict the efficacy and adverse events of apatinib in patients with malignancies.~      Integrin αvβ3 has been shown to play an important role in angiogenesis and up-regulated~     obviously in various types of tumor cells and activated endothelial cells. The~     arginine-glycine-aspartic acid (RGD) tripeptide sequence can bind to integrin αvβ3 with high~     affinity and specificity. The 18F-ALF-NOTA-PRGD2 will highly combine with αvβ3, and thus will~     monitor the antiangiogenic status.In the current study, investigators propose to evaluate the~     feasibility of 18F-RGD PET/CT in monitoring efficacy and adverse events of apatinib in~     malignancies.~   "
13934|NCT03384498|"~     This study is to determine the prevalence and geographical distribution of antimalarial drug~     resistance-linked genetic mutations in clinical P. falciparum infections in the Greater~     Mekong Subregion~   "
13937|NCT03384459|"~     Although vitiligo is difficult to cure, recurrences are frequent after treatment, and many~     patients suffer from concerns about recurrence as well as disease. Psoriasis, another~     indication for ultraviolet radiation treatment, has been established that it can safely and~     effectively reduce the recurrence of psoriasis through monthly maintenance therapy. The aim~     of this study was to evaluate the efficacy of 308-nm excimer laser therapy for the prevention~     of relapse in vitiligo.~   "
13938|NCT03384446|"~     Dental implants have revolutionized the field of dentistry, providing improvements in~     function and esthetics. They are not, however, without risks. Bone loss around implants (i.e.~     periimplantitis) is an emerging public health concern. Untreated, peri-implantitis leads to~     implant loss and jawbone defects. Nonetheless, existing therapies have failed to show~     long-term efficacy. The pathogenesis of peri-implantitis is believed to be of bacterial~     etiology similar to periodontal disease. Therefore, existing treatments duplicate strategies~     for the treatment of natural teeth. However, the titanium (Ti) surface of implants is quite~     dissimilar to teeth. Recent work from our lab has demonstrated that peri-implantitis is~     associated with increased release of Ti particles around implants. These findings suggest~     that treatments targeting periimplantitis must be designed around Ti material properties. A~     gap in knowledge exists regarding the potential triggers of increased Ti dissolution from the~     implant surface and the mechanisms by which Ti dissolution products amplify peri-implant~     inflammation. The aim of this study is to determine if the use of tooth-driven treatment~     approaches increase Ti in the submucosal plaque.~   "
13939|NCT03384433|"~     Administration of cell-free exosomes derived from mesenchymal stem cell (MSCs) can be~     sufficient to exert therapeutic effects of intact MSCs after brain injury. In this study we~     aim to assay the administration of MSC derived exosome enriched by miR-124 on improvemen of~     disability of patients with acute ischemic stroke~   "
13940|NCT03384420|"~     Mitochondrial diseases are a genetically heterogeneous group of disorders caused by mutations~     or deletions in mitochondrial DNA (mtDNA) displaying a wide range of severity and phenotypes.~     These diseases may be inherited from the mother (mitochondrial inheritance) or non-inherited.~     The latter are ultra-rare pediatric diseases caused by a mutation or deletion of mtDNA, which~     develop into a systemic multi organ disease and eventually death. MNV-BM-BLD is a therapeutic~     process for enrichment of patient's peripheral hematopoietic stem cells with normal and~     healthy mitochondria derived from donor blood cells. The process, called mitochondria~     augmentation therapy, aims to reduce the symptoms of mitochondrial diseases.~   "
13941|NCT03384407|"~     The pilot study has two objectives: 1) to assess the post-infusion viability of INTERCEPT RBC~     by measuring the 24 hour post-infusion recovery (PTR24) and lifespan of autologous RBCs~     prepared with the INTERCEPT System for RBC after storage for 35 days under standard blood~     banking conditions using two different RBC labels; 51-chromium and biotin. The control will~     be conventional untreated RBCs stored for 35 days; and 2) comparison and contrast of PTR24~     and lifespan results of the 51-chromium and biotin labeling methods of RBC stored for 35 days~     under standard blood banking conditions. The purpose of gathering these data is to obtain~     more meaningful survival data for stored conventional and INTERCEPT RBCs over the entire 120~     d RBC lifespan (51-Cr labeled RBC permits a maximum 28 d assessment as a result of 51-Cr's~     variable, progressive elution from RBC and radioactive half-life).~   "
13942|NCT03384394|"~     Respiratory distress after extubation is associated with increased morbidity and mortality.~     Its multifactorial pathophysiology causes a loss of pulmonary aeration during the weaning~     process, the clinical translation being impaired gas exchange and the occurrence of~     respiratory distress. Lung ultrasound can accurately quantify the loss of pulmonary aeration~     before, after end during the weaning trial by calculating the Lung Ultrasound Score (LUS).~     Investigators have recently demonstrated in a prospective two-center study of 100 patients~     that the intensity of the lung aeration loss occurring during the weaning trial, was~     predictive of the development of postextubation respiratory distress within 48 hours~     following extubation. A LUS ≥ 14 could identify patients at high risk of developing~     postextubation respiratory distress. A second study that investigators have just completed in~     80 patients weaned from mechanical ventilation shows a 30% reduction of respiratory distress~     in post-extubation High Flow Nasal Cannula oxygen group compared to a standard O2 group.~      The establishment of a targeted therapeutic strategy proposed in a group of high-risk~     patients, defined as having a ≥ 14 LUS at the end of the weaning trial could reduce the~     incidence of extubation failure and associated morbidity and mortality.~   "
13943|NCT03384368|"~     Controversies persist for the best treatment of burst fractures of the thoracolumbar spine.~     Posterior fixation alone may be adequate to achieve and maintain burst fractured reduction.~     Adding screws in fractured segment has been proved in many literature that can improve~     construct stiffness; however, no previous reports exist describing the different efficacy~     between diverse order of adding screw placement in fractured vertebrae.~   "
13944|NCT03384355|"~     In this prospective, observational study, the investigators aim to investigate the symptoms~     of varicose vein patients.~   "
13945|NCT03384342|"~     Although vitiligo is difficult to cure, recurrences are frequent after treatment, and many~     patients suffer from concerns about recurrence as well as disease. Psoriasis, another~     indication for ultraviolet radiation treatment, has been established that it can safely and~     effectively reduce the recurrence of psoriasis through monthly maintenance therapy.~      The aim of this study was to evaluate the efficacy of Narrow-band UV-B therapy for the~     prevention of relapse in vitiligo.~   "
13946|NCT03384329|"~     Patients with depression (target number - 60) receive resveratrol 500 mg or placebo (1:1)~     each morning daily for 1 month with primary outcome measures of the score change on~     depression rating scale HDRS-17 and change in SIRT1 activity in the blood measured 4 times~     over the study period (before, in the middle, after the intervention, and in 2 week follow~     up).~   "
13966|NCT03384069|"~     The aim of the study is to test the feasibility and acceptability of a six-month~     cognitive-behavioral therapy (CBT) program (group based and phone-based) compared with usual~     care, and to determine if the intervention can improve cognitive performance and reduce~     chronic stress in a randomized trial including 60 African American patients with Mild~     Cognitive Impairment (MCI). The CBT program among African Americans with MCI will provide~     preliminary evidence about the efficacy and the optimal intensity of the intervention needed~     for patients at risk of Alzheimer's disease (AD).~   "
14043|NCT03383068|"~     To investigate whether intensive metabolic intervention of PCOS women before pregnancy can~     improve pregnancy outcome.Besides, the investigators aim to investigate the best therapy~     strategy of metabolic intervention before pregnancy.The investigators plan to recruit PCOS~     women at childbearing age. By using acarbose, GLP-1 analogue, berberin et al. the~     investigators will intervent the participants' metabolic statues for 3 months before~     pregnancy and to compare outcome in each group.~   "
13947|NCT03384316|"~     Background:~      ETBX-011, ETBX-061, and ETBX-051 are cancer vaccines. Their goal is to teach the immune~     system to target and kill cancer cells. The vaccines target 3 proteins found in many types of~     cancer. Researchers think targeting all 3 proteins in unison will have the best results.~      Objective:~      To test the safety of combining ETBX-011, ETBX-061, and ETBX-051 and their effects on the~     immune system.~      Eligibility:~      People ages 18 and older with advanced cancer that has not responded to standard therapies~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Blood, urine, and heart tests~      Scan: They will lie in a machine that takes pictures of the body.~      Participants will receive the 3 vaccines through 3 shots under the skin every 3 weeks for 3~     doses, then every 8 weeks for up to 1 year. They will have blood and urine tests at each~     vaccine visit. They will have scans and other measurements of their tumor after 9 weeks and~     then at their vaccine visits every 8 weeks.~      Participants will keep a diary of symptoms at the injection site.~      Participants will have a visit 90 days after their final treatment. This will include a~     physical exam and blood and urine tests. If they have any ongoing side effects, they will be~     followed until these end or are not changing.~      After this visit, they will be called every 3 months for the first year, every 6 months for~     the next 2 years, then every 12 months for another 2 years to see how they are doing.~      Participants will have the option to enroll in a long-term follow-up study.~   "
13948|NCT03384303|"~     Obesity is an increasing world wide problem. Moreover, the increase in patients who are~     considered morbidly obese is even higher (Sturm et al, Healt Aff 2004). Conservative~     approaches such as diets or medication are unsuccessful in the majority of the patients.~     Additionally, (morbid) obesity leads often to cardiovascular diseases, such as hypertension,~     dyslipidemia and type 2 diabetes (T2DM). When patients need insulin to regulate their glucose~     levels, their weight is even more difficult to control. Therefore, bariatric procedures are~     increasingly performed, with over 8.000 procedures in the Netherlands in 2013. The two most~     performed types of bariatric surgery in the Netherlands are the Laparoscopic Roux-en-Y~     Gastric Bypass (LRYGB) and the Laparoscopic Sleeve Gastrectomy (LSG). Within the LRYGB there~     are different variants available. In a recently initiated randomized controlled trial (RCT)~     from our centre, a comparison between two variants of RYGB was performed. In this RCT our~     standard RYGB (s-RYGB:alimentary limb (AL) of 150cm; biliopancreatic limb (BPL) of 75cm) was~     compared with a RYGB with an long BPL (LBPLRYGB:AL of 75cm and a BPL of 150cm). A LBPLRYGB~     might improve weight loss and reduction after surgery. The exact mechanism of action is still~     not fully understood. Stomach volume is decreased and satiety levels often increase, probably~     due to changes in incretin levels. Passage of foods through the gastrointestinal tract are~     altered after RYGB. A possible explanation might be found in different levels of incretins~     (such as GLP-1, PYY and ghrelin) and bile acids (FGF-19 and FGF-21) after bariatric surgery.~   "
13949|NCT03384290|"~     A Dose Escalating Study of PRS-060 Administered by Oral Inhalation in Healthy Subjects~   "
13950|NCT03384277|"~     Purpose:~      To evaluate the efficacy when administering steroid combined with small dose rituximab to~     eliminate the antibody in acquired hemophilia A patients compared to treatment using steroid~     with cyclophosphamide.~      The study will test the hypothesis that steroid combined with small dose rituximab is as~     effective as steroid combined with cyclophosphamide for FVIII inhibitor eradication in~     Chinese patients with acquired hemophilia A.~      Study design Allocation: Randomized Intervention Model: Parallel Assignment Masking: None~     (Open Label) Primary Purpose: Treatment~   "
13951|NCT03384264|"~     This study aimed to analyze the effects of a 12-week suspension exercise training programme~     on handgrip strength (HG) and anthropometric and bioelectrical impedance parameters in older~     adults.~   "
13952|NCT03384251|"~     The study is designed to assess the impact of an educational intervention program on the~     knowledge, attitude and behaviour towards pregnancy prevention based on Health Belief Model~     amongst adolescent girls in Northern Ghana. It is a randomised clustered controlled trial to~     be conducted on Senior High School students in Northern Ghana The study hypothesises that~     knowledge, attitude and behaviour of adolescents towards pregnancy prevention will differ~     between the groups.~   "
13953|NCT03384238|"~     This phase I/II trial studies the side effects and best dose of panitumumab-IRDye800 and to~     see how well it works in finding cancer in patients with pancreatic cancer who are undergoing~     surgery. Panitumumab-IRDye800 is a combination of the antibody drug panitumumab and~     IRDye800CW, an investigational dye that can be seen using a special camera.~     Panitumumab-IRDye800 may attach to tumor cells and make them more visible during surgery in~     patients with pancreatic cancer.~   "
13954|NCT03384225|"~     Aim: To evaluated if cladribine based conditioning (CBA) could decrease relapse after~     haploidentical allogeneic HSCT in high risk and refractory AML patients as compared with~     fludarabine based conditioning regimen(FBA).~      Study design: open-labed, prospective, multicenter, randomized control study Number of~     subjects: 60 each group~      Treatment:~      CBA group: CBA as HSCT conditioning which including cladribine 5mg/m2 day~      -6 to day -2 , busulfan(iv) 3.2mg/kg day-6 to day -3 and cytarabine 2g/m2 day-6 to day -2.~     FBA group: FBA as HSCT conditioning which including fludarabine 30mg/m2 day -6 to day -2,~     busulfan(iv) 3.2mg/kg day-6 to day -3 and cytarabine 2g/m2 day-6 to day -2.~   "
13955|NCT03384212|"~     Aim: To evaluated if cladribine based conditioning (CBA) could decrease relapse after HLA~     matched HSCT in high risk and refractory AML patients as compared with fludarabine based~     conditioning regimen(FBA).~      Study design: open-labed, prospective, multicenter, randomized control study Number of~     subjects: 60 each group~      Treatment:~      CBA group: CBA as HSCT conditioning which including cladribine 5mg/m2 day -6 to day -2 ,~     busulfan(iv) 3.2mg/kg day-6 to day -3 and cytarabine 2g/m2 day-6 to day -2.~      FBA group: FBA as HSCT conditioning which including fludarabine 30mg/m2 day -6 to day -2,~     busulfan(iv) 3.2mg/kg day-6 to day -3 and cytarabine 2g/m2 day-6 to day -2.~   "
13975|NCT03383952|"~     Immunotherapy offers an extremely precise approach with the potential to eliminate cancer~     cells specifically. The newly designed CD19 targeted ICAR19 T cells can specifically kill~     CD19+ tumor cells. ICAR19 CART used the second generation of CART designation. In this study,~     the participants will receive several doses of autologous ICAR19 T cells and the~     investigators will determine the safety and therapeutic effects of these cells.~   "
48129|NCT02936934|"~     The objective of this study is compare adverse reactions associated with oxycodone and~     morphine for the treatment of postoperative pain after abdominal hysterectomy~   "
13956|NCT03384199|"~     Gold markers implanted in the prostate are used frequently for position verification of the~     prostate during external-beam radiotherapy. By using the markers as a surrogate for the~     prostate itself, not only set-up errors, but also the internal motion of the prostate~     relative to the bony anatomy can be identified.~      It is thus believed that escalated dose marker guided radiotherapy should result in better~     biochemical control compared to conventional external beam radiotherapy, with a similar or~     lower incidence of toxicity. However, clinical data to support this is still limited. The~     purpose of this study is to directly compare late toxicity as well as biochemical control~     between patients treated with dose escalated marker guided radiotherapy versus conventional~     dose non-marker guided radiotherapy who has otherwise been treated with similar radiotherapy~     planning techniques and equipment.~      Prostate magnetic resonance imaging has undergone several technical improvements and shows~     promises for prostate tumor detection and localization. In addition to morphological~     information, magnetic resonance imaging allows an estimation of physiological properties of~     tissues. Diffusion-weighted magnetic resonance imaging is sensitive to restriction of~     diffusion of water molecules, and dynamic contrast enhanced magnetic resonance imaging can~     analyze tissue micro vascular properties. Multi para metric magnetic resonance imaging~     combining Diffusion-weighted and Dynamic contrast enhanced has demonstrated its value in~     distinguishing malignant from benign prostate tissue.~      Higher radiation dose levels were consistently associated with improved biochemical control~     outcomes and reduction in distant metastases. Radiation dose was one of the important~     predictors of long-term biochemical tumor control. Dose levels < 70.2 Grey and 70.2-79.2 Grey~     were associated with 2.3 and 1.3-fold increased risks of pro static specific antigen relapse~     compared with higher doses. However, further dose escalation to the whole gland is limited~     due to an unacceptable high risk of acute and late toxicity. Moreover, local recurrences~     often originate at the location of the macroscopic tumor, so boosting the radiation dose at~     the macroscopic tumor within the prostate might increase local control. A reduction of~     distant metastases and improved survival can be expected by reducing local failure. Treating~     the dominant focus or boosting the dose to this area while reducing the dose to as much~     healthy tissue as possible has significant potential for improving treatment.~   "
13957|NCT03384186|"~     The purpose of this study is to evaluate and compare the plasma PK profiles of study drug,~     ACH-0144471, in healthy subjects after administration of a single dose of multiple~     ACH-0144471 prototype formulations given by mouth.~   "
13958|NCT03384173|"~     This study will examine the relationship of oxygen levels, using NIRS monitoring, and kidney~     injury in infants born prematurely. NIRS is a skin sensor which detects the amount of oxygen~     going to different organs, most often used to monitor the brain and kidney.~   "
13959|NCT03384160|"~     The extraction of third molars, a frequent treatment in clinical dental practice, can lead~     patients to painful symptoms during and after surgery. The dental surgeon must correctly~     indicate the need for extraction and also provide patients who need this treatment greater~     comfort and control of pain in the trans and postoperative period. Thus, it is necessary to~     use an effective local anesthetic favoring the factors inherent to the postoperative and~     achieving good treatment results.~   "
13960|NCT03384147|"~     Metabolic imprints of five different types of alcohol will be investigated in two study~     groups.~      The study will be an assessor-blinded, parallel dietary trial (crossover design).~      The project aims to identify the chemical nature and kinetics of metabolite changes related~     to alcohol, hops, grapes and other beverage constituents as well as the brewing processes.~   "
13961|NCT03384134|"~     The purpose of this study is to examine the feasibility of the ambulatory monitoring~     protocol, called Pain Buddy, in documenting children's pain, symptoms and quality of life~     while receiving outpatient chemotherapy. The long term goal of Pain Buddy is to help doctors,~     nurses, and parents get the information they need to give children treatments for pain and~     symptom management that work. Using Pain Buddy, we aim to quantify the prevalence and~     intensity of daily pain and symptom episodes in children at home, data that will be used to~     develop a psychosocial intervention to be delivered electronically to children at home with a~     goal of improving quality of life. Secondary aims also include examining children's quality~     of life pre- and post- Pain Buddy and satisfaction with the use of Pain Buddy. This project~     has the potential to improve the quality of life of tens of thousands of children suffering~     from cancer each year using transformative mobile health information technology based~     approach to pain assessment and management.~   "
13962|NCT03384121|"~     Idiopathic infantile hypercalcemia(IIH) is a rare,genetic disorder of mineral metabolism.~     Biallelic loss of functions mutations of CYP24A1, the gene encoding the 24-hydroxylase enzyme~     that represents the principal pathway for inactivation of vitamin D metabolites, cause the~     most common and severe form of IIH.Investigators have preliminary data supporting a novel~     therapeutic approach to suggest rifampin as an investigational drug to induce over-expression~     of CYP3A4, an important enzyme that provides an alternate catabolic pathway for inactivation~     of vitamin D metabolites. In this study, investigators will recruit 5 patients with biallelic~     inactivating mutations of CYP24A1. Participants will be followed prospectively for a total~     6-11 months. This will include 2 months of observation, 2 months of receiving the starting~     dose of rifampin, followed by 2 month washout phase. Efficacy of the starting dose of~     rifampin will be determined prior to proceeding only in non responders to the escalation dose~     of rifampin 10mg/kg/day.~   "
13963|NCT03384108|"~     This pilot study will first establish the feasibility of an in vivo methodology of assessing~     the utilization of glutamine into the TCA cycle of normal bone marrow plasma cells from~     healthy subjects while comparing it to an ex vivo approach~   "
13964|NCT03384095|"~     This is a single center, double-blinded, placebo-controlled, randomized Phase II trial to~     determine whether oral hyaluronic acid will prevent aromatase inhibitor (AI)-associated~     arthralgias. Subjects must have ER/PR-positive breast cancer tumor with history of aromatase~     inhibitor-associated musculoskeletal symptoms (AIMSS) which resolved after cessation of their~     AI (anastrazole or letrozole) within 90 days of enrollment. Subjects will be stratified by~     initial AI, thus within each initial AI, subjects will be randomized to receive either the~     experimental treatment (hyaluronic acid) or placebo. Subjects will begin the assigned~     treatment for 2 weeks prior to transitioning to the second AI. Evaluations will be taken at~     baseline, 6 weeks (1 month on study drug and AI), 14 weeks (3 months on study drug and AI),~     and at 26 weeks (6 months on study drug and AI). Treatment with hyaluronic acid and placebo~     will last for 26 weeks total.~   "
13965|NCT03384082|"~     82 cases of recurrent miscarriage women with a diagnosis of arcuate uterus, confirmed by~     three-dimensional intra-vaginal sonography (3D-TVS) and hysteroscopy, will be recruited. The~     subjects will be randomly divided into two groups, the experimental group will be given~     hysteroscopic treatment, the control group will receive no treatment. The pregnancy rates~     (>12 weeks) of the two groups will befollowed and compared.~   "
14003|NCT03383588|"~     Camparing post-op pain scores and oxycodone usage in patients who receive jsut intrathecal~     morphine to patients who receive intrathecal morphine plus subcutaneous bupivacaine .25%, to~     patients who receive bupivacaine .25% with epinephrine 1:200,000. Oxycodone usage and pain~     scores~   "
13967|NCT03384056|"~     The investigators aim to compare the airway seal pressure( oropharyngeal leak pressure) of~     the Self Pressurized Airway Device with Blocker® with the ProsealTM Laryngeal Mask Airway~     (P-LMA)in anesthetized paralyzed adult female patients undergoing elective gynecological~     operations. The investigators aim at assessment of fitting of both devices against the~     glottic region that detected by the flexible fiberoptic bronchoscope( Pentex Corporation,~     Medical Division, Singapore)and assessment of any associated postoperative complications.~      Hypothesis:~      The investigators hypothesize that the self-pressurized air-Q with blocker has a greater seal~     pressure compared to Proseal, easier and faster in insertion with less morbidity and~     complications during and after its insertion.~   "
13968|NCT03384043|"~     Alzheimer's disease is a debilitating condition for patients and their caregivers marked by~     hallmark cognitive symptoms (e.g., memory loss) as well as an impact on quality of life.~     Researchers and clinicians are learning that a specific type of memory, called prospective~     memory, may be particularly affected in mild Alzheimer's disease. Prospective memory is~     memory for future intentions, goals, and chores, and the loss of the neurocognitive processes~     supporting prospective memory may reduce independent functioning (e.g., medication~     adherence). The current study investigates a technology-based intervention to assist~     participants with their daily prospective memory tasks. Participants with mild cognitive~     impairment and mild Alzheimer's disease will be trained to use a smartphone for four weeks.~     Smartphone acceptability, usability, and overall user experience will be measured.~     Furthermore, participants will be tested on completion of daily prospective memory tasks. In~     one group, participants will train to use the smartphone personal assistant reminder system,~     which reminds participants of their goals, tasks, and chores at the appropriate time or~     location. In a comparison group, participants will also carry a smartphone but will train to~     use a memory strategy in which they verbalize external cues to remind them to perform their~     goals, tasks, and chores. The goal of this research is to inform whether smartphone~     technology or a memory strategy can be used to reduce memory burden and improve daily,~     independent functioning in participants with mild Alzheimer's disease.~   "
13969|NCT03384030|"~     In the MOIST study it will be assessed whether the adapted Sternberg short-term working~     memory task (STMST) is an effective method to induce malodor formation by emotional stress,~     as assessed by expert assessments of stress-induced malodor formation in the armpits of 30~     healthy male volunteers.~      Before, during and after being exposed to the adapted version of the STMST, saliva will be~     collected to determine cortisol levels, subjects have to rate their momentary feelings of~     anxiety and embarrassment and heart rate variability will be monitored continuously with a~     wireless signal transmission device. Before and after exposure to the adapted STMST, malodor~     levels will be assessed by two expert judges, axillary volatiles will be collected by cup~     scrubbing and microbiota samples will be taken to determine microbial species.~   "
13970|NCT03384017|"~     Aim 1: Determine the neurophysiologic impact of Transcutaneous Spinal Cord Stimulation (TSCS)~     within a single session. The investigators hypothesize that subjects will demonstrate~     increased volitional muscle activity and strength with TSCS. This will be assessed by surface~     EMG and hand-held dynamometry of the dominant-side quadriceps muscle during maximum~     volitional contraction (MVC) and measurement of gait speed. Subjects will be tested in both~     TSCS and sham conditions.~      Aim 2: Determine the impact of TSCS and gait training on walking function. The investigators~     hypothesize that concurrent TSCS and gait training will augment walking function in subjects~     with iSCI, as compared to gait training alone. Subjects will participate in an eight-week~     program of gait training with TSCS and be assessed with clinically relevant outcome measures,~     to include the Timed Up and Go, 10-Meter Walk Test, Walking Index for Spinal Cord Injury II,~     and 6-Minute Walk Test.~   "
13971|NCT03384004|"~     The aim of the present study is to assess with PA x-rays and CBCT scans the volumetric~     changes in periapical radiolucencies in endodontically treated teeth 1 year after endodontic~     treatment and evaluate how well the lateral canals are filled after irrigation with the new~     generation of negative irrigation pressure unit with and without the ultrasonic irrigation.~   "
13972|NCT03383991|"~     Proximal humeral fractures are common injuries with the highest incidence being amongst the~     elderly. Most proximal humeral fractures are nondisplaced or minimally displaced. The~     majority of these are reliably treated nonoperatively with an acceptable functional outcome.~     The treatment of displaced fractures is more controversial. Consensus is lacking as to when~     surgery is indicated or what type of procedure to choose if surgery is elected. Displaced 3-~     and 4-part fractures where internal fixation is deemed unreliable have been considered an~     indication for hemiarthroplasty. Hemiarthroplasty gives reasonable control of pain but the~     resulting shoulder function and range of motion is unpredictable. The use of reverse total~     shoulder arthroplasty is increasing and might result in a better range of motion then~     hemiarthroplasty.~      The aim of this multicenter study is to test the hypothesis that reverse total shoulder~     arthroplasty gives better shoulder function than hemiarthroplasty for displaced 3- and 4-part~     proximal humeral fractures.~   "
13973|NCT03383978|"~     The main objective of this clinical study is to evaluate the safety and tolerability of~     NK-92/5.28.z (HER2.taNK) and to determine the maximum tolerated dose or maximum feasible dose~     (MFD). Recommended phase 2 doses both for intraoperative injections only (RP2Diio) and~     repetitive injections (RP2Dri) will be determined. Frequent side effects and target organs of~     toxicity and their severity, duration and reversibility will be determined. Furthermore,~     pharmacokinetics and pharmacodynamics will be examined. In addition, potential signs of~     anti-tumor activity of NK-92/5.28.z cells will be analyzed.~   "
13974|NCT03383965|"~     CAR-T cells have been validated effective in treating CD19 positive B cell lymphoma. Other~     lymphomas like Hodgkin's lymphoma and anaplastic large cell lymphoma are CD30 positive. In~     this study, a newly CD30 targeted CART therapy ICAR30 is designed to specifically kill those~     CD30 expressing malignancies including Hodgkin's lymphoma and CD30+ anaplastic large cell~     lymphoma. The subjects will receive several doses of autologous ICAR30 T cells infusion and~     then the safety, treating effects and lasting period of these cells in vivo will be~     evaluated.~   "
14017|NCT03383406|"~     A phase II trial of ifosfamide, etoposide, cytarabine, and methotrexate (IVAM) chemotherapy~     for refractory or relapsed diffuse large B cell lymphoma~   "
14018|NCT03383393|"~     After PCI searching for target lesion ischemia with intracoronary ECG will be performed and~     if found it will be treated pharmacologically~   "
13976|NCT03383939|"~     Aim: to investigate the influence of alpha1-antitrypsin (A1-AT) nebulization on levels of~     A1-AT in BAL and plasma in patients with stable bronchiectasis.~      Method: single-blind placebo-controlled randomised clinical trial. 19 stable bronchiectasis~     patients with chronic bronchial infection and 10 control patients (without bronchiectasis)~     underwent a bronchoscopy in order to assess levels and inhibitory capacity of A1AT and~     neutrophilic elastase. Afterwards, the 19 bronchiectasis patients were randomly allocated to~     receive inhaled A1AT 250mg diluted in 10ml 0.9% saline solution once a day for a month (Group~     A, n: 10) or placebo (10ml 0.9% saline solution; group B, n: 9). A new BAL was performed in~     both groups (A and B) 24 hours after the end of treatment (1month) to re-analyze A1AT and NE.~   "
13977|NCT03383926|"~     The aim of this study is to define the significance of the distance of the staple line to the~     dentate line of the anal canal in the efficacy of the Longo's intervention.~   "
13978|NCT03383913|"~     This study will test the hypothesis that Heart Rate Variability Biofeedback (HRV-B) restores~     autonomic balance and reduces pain and other symptoms among patients with sickle cell disease~     (SCD).The specific aims of this study are to: (1) conduct a randomized, wait list controlled,~     pilot intervention trial to determine whether HRV-B increases HRV coherence among SCD~     participants (minimum N of 30, up to 50 total); (2) determine whether HRV-B reduces pain,~     stress, fatigue, depression or insomnia among SCD participants; and (3) determine whether~     increases in HRV coherence are associated improvements in pain, stress, fatigue, depression,~     or sleep among study participants.~   "
13979|NCT03383900|"~     The training of the respiratory muscles seems to be fundamental in people who require a high~     physical demand. There is abundant scientific evidence that relates the respiratory variables~     and the limitation to exercise. The published studies are athletics and cycling, however it~     is scarce in football. Objective. To assess the effects of inspiratory muscle training on~     lung function and sports performance in soccer players.~   "
13980|NCT03383887|"~     Obstructive sleep apnea (OSA) is common and has major health implications but treatment~     options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle~     activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared~     to normal subjects. In this protocol the investigators will test the effect of DAW1033D~     administered before sleep on OSA phenotype traits and OSA severity during sleep.~   "
13981|NCT03383874|"~     This will be a 24-week, randomized, double-blind, placebo-controlled trial of adjunctive~     probiotic therapy in 66 persons hospitalized with a manic or mixed episode. The active study~     compound will consist of capsules containing approximately 10^9 colony forming units of the~     probiotic organisms, Lactobacillus GG and Bifidobacteria lactis strain Bb12. The dose has~     been selected because it has been used safely in other probiotic trials, was well-tolerated~     by the participants in two previous trials of individuals with schizophrenia or mania, and~     was utilized in the original trial on which this replication is based. This dose is higher~     than that available in most commercially-sold health food supplements. Following hospital~     discharge, participants will be randomized to receive adjunctive probiotic or placebo for a~     24 week period. It is anticipated that of the 66 participants randomized, ~50 (75%) will~     complete the full 24 weeks of the study. The primary outcome is relapse, defined as~     re-hospitalization (e.g., admission to an inpatient unit) for psychiatric symptoms following~     a previous hospital discharge by at least 2 weeks. The occurrence of new mood episodes, the~     severity of psychiatric symptoms, and any changes in cognitive test scores over the course of~     the study will also be evaluated. Changes in the levels of inflammatory markers as well as~     changes in gut microbiota will be evaluated at three time intervals over the course of the~     study.~   "
13982|NCT03383861|"~     The association between selective serotonin reuptake inhibitor (SSRI) use and bone mass~     density (BMD) has been debated. Some have suggested features of depression, which SSRIs are~     prescribed to treat, may be a cause of decreased BMD, such as poor overall food intake at the~     time of SSRI use. Our study seeks to determine whether SSRI use in adults is associated with~     lower than average BMD, and if there is an association between low micronutrient intake, SSRI~     use, and a low BMD.~   "
13983|NCT03383848|"~     This study will evaluate if an electronic medication management software solution can improve~     outcomes for patients undergoing in vitro fertilization (IVF) treatment. Participants will be~     randomized equally into two groups: half will use the management software, while the other~     half will act as a control group.~   "
13984|NCT03383835|"~     This pilot study is an investigation of feasibility of moderate dose omega-3 fatty acid~     supplementation in pre-menopausal women at high risk for breast cancer who are considering~     future pregnancy. The goal of this pilot study is to determine feasibility of the study,~     document compliance with omega-3 fatty acid supplementation in this population and identify~     novel biomarkers modulated by moderate dose omega-3 fatty acids in this population.~   "
13985|NCT03383822|"~     It is well known that the hormone insulin lowers blood glucose in part by acting directly on~     the liver and reducing hepatic glucose production. Animal studies have shown that the hormone~     insulin can act on the brain to indirectly lower glucose production by the liver. It has~     previously been shown that a nasal spray can deliver insulin directly to the brain without~     affecting circulating insulin concentration in humans. Intranasal spray of insulin suppressed~     hepatic glucose production in lean subjects. It is unknown whether this effects is blunted in~     subjects with insulin resistance.~   "
13986|NCT03383809|"~     This is an acute human bioavailability study in self-reported healthy participants aged 20-70~     years old. We hypothesize that combination of dietary polyphenolics and non-digestible~     carbohydrates (NDC) will increase the production of phenolic acids by bacteria in the human~     colon and these will be detected in urine. Participants will attend for three arms in a~     randomised order: Strawberry juice (a high polyphenol food), Inulin (NDC) or Mixture of~     strawberry juice and inulin.~   "
14019|NCT03383380|"~     The purpose of this proposed research is to evaluate the efficacy and safety of the rapamycin~     therapy in patients with activated phosphoinositide 3-kinase δ syndrome (APDS).~   "
14044|NCT03383055|"~     This is a single-arm, prospective, interventional study administering 2 doses of the~     experimental vaccine (CMV-MVA Triplex) to 20 evaluable patients (10 CMV-seropositive and 10~     seronegative) undergoing autologous hematopoietic cell transplantation (HCT) for lymphoma or~     myeloma on days 28 and 56 post-HCT. The absolute number of adaptive NK cells~     (CD56dimCD57+NKG2C+) at various days will be compared.~   "
13987|NCT03383796|"~     Cholangiocarcinoma (CCA) is the most common biliary tract malignancy and the second most~     common primary hepatic malignancy. The prognosis of CCA is dismal. Surgery is the only~     potentially curative treatment, but the majority of patients present with advanced stage~     disease, and recurrence after resection is common. It is classified into intrahepatic (iCCA),~     perihilar (pCCA), and distal (dCCA) subtypes. Among all, pCCA is the most common subtype.~      This is a prospective, randomized, controlled multicenter trial with two treatment arms,~     three dimension laparoscopic approach versus open approach. The trial hypothesis is that~     three dimension laparoscopic surgery has advantages in postoperative recoveries and be~     equivalent in operation time, oncological results and long-term follow-up compared with open~     counterpart. The duration of the entire trial is two years including prearrangement,~     follow-up and analyses.~   "
13988|NCT03383783|"~     The purpose of this study is to evaluate the fluoride dose response of different dentifrice~     fluoride concentrations - 0, 250, 500 and 1100 ppm fluoride of our existing in situ model~     involving the use of human enamel specimens placed in the buccal flange area of the subjects~     partial denture with the modified model involving placement of bovine enamel specimens in a~     denture tooth location.~   "
13989|NCT03383770|"~     Regional anaesthesia is a frequently used procedure. Currently, blockades are increasingly~     carried out without nerve stimulation. The risk of nerve lesion is about 3 %. Industrial~     efforts frequently referred to ultrasound optimisation of the regional anaesthesia cannula.~     In order to optimise patient safety, the benefit of both procedures (stimulation and~     ultrasound) should be combined and both procedures optimised. In this study, the influence of~     the needle electrode size on the stimulability of the nerve ischiadicus should be determined.~   "
13990|NCT03383757|"~     The purpose of the study is to demonstrate proper function of the U-TruSignal device via~     clinical performance testing in a neonatal human subject population under standard clinical~     conditions. A study with human subjects will provide the needed clinical evidence for~     assessing the accuracy of the pulse oximeter as recommended by the FDA Guidance Document~     (Pulse Oximeters - Premarket Notification Submissions [50(k)s]: Guidance for Industry and~     Food and Drug Administration Staff.)~   "
13991|NCT03383744|"~     This is a study to evaluate the effects of vitamin A supplementation program on the vitamin A~     status of preschool children. All children aged 3-5 years who do not have severe illness and~     are not planning to move from the study area are eligible. Children whose caregivers agree to~     sign the consent form will be enrolled in their community and submitted to a longitudinal~     evaluation of vitamin A status before and after vitamin A supplementation campaign.~      Vitamin A status will be assessed by measuring serum retinol, retinol binding protein and~     vitamin A total body pool size using stable isotope dilution methodology.~   "
13992|NCT03383731|"~     This study evaluates the surgical outcomes of inverted internal limiting membrane insertion~     combined with air tamponade in the treatment of macular hole retinal detachment (MHRD) in~     high myopia, and also to compare the treatment efficacy and safety between different surgical~     approaches of MHRD~   "
13993|NCT03383718|"~     Enrollment:~        -  Patients with stable coronary artery disease (SCAD) and moderate coronary artery~          stenoses (30-70 %)~        -  Patients with acute myocardial infarction and moderate stenosis of non-culprit arteries~          (NCL; BYSTANDER LESION)~      Aims:~        -  To assess the diagnostic accuracy of dobutamine stress echocardiography (DSE) and~          invasive fractional flow reserve (FFR) measurement~        -  To assess the prognostic impact of reclassification by a mismatching negative test~      Hypothesis:~        -  DSE and FFR have similar prognostic value in both clinical settings (SCAD and NCL)~        -  Considering the strong negative predictive value of both DSE and FFR, one negative test~          is sufficiently enough to defer revascularisation, even in the case of mismatch~   "
13994|NCT03383705|"~     This is an open-label, single-center study. Subjects in this study will receive up to four~     (4) facial treatments at 4-6 (±1) weeks interval, with the VBeam Prima device according to~     the study protocol. Subjects will return for follow‐up (FU) visits at the clinic at 1 and 3~     months following the last treatment.~   "
13995|NCT03383692|"~     HER2-positive cancer is a cancer that tests positive for a protein called human epidermal~     growth factor receptor 2 (HER2). HER2 promotes the growth of certain cancer cells. This study~     will test an experimental drug called DS-8201a that has not been approved by the health~     authorities yet.~      DS-8201a will be tested for safety in patients with advanced solid malignant tumors that test~     positive for HER2. It also will test how DS-8201a moves within the body (pharmacokinetics).~   "
13996|NCT03383679|"~     This is a multicenter uncontrolled, open-label, prospective, non-comparative randomized,~     phase II study. Patients will be randomized between darolutamide in Arm n°1 (two-stage~     Simon's design) and capecitabine in Arm n°2 with two patients randomized in Arm n°1 for one~     patient randomized in Arm n°2.~      The trial population is composed of women over 18 years old with triple-negative and androgen~     receptor positive, locally recurrent (unresectable) or metastatic breast cancer.~   "
13997|NCT03383666|"~     This is a prospective, multi-center, non-randomized clinical evaluation utilizing the~     PulseRider® Aneurysm Neck Reconstruction Device.~   "
13998|NCT03383653|"~     To assess any serious systemic reaction within 30 minutes after Td immunization in pregnant~     woman~   "
13999|NCT03383640|"~     A controlled randomized trial, including patients undergoing finger replantation surgery. The~     Control Group will receive a standardized post operative rehabilitation regime, whilst the~     Intervention Group will receive a rehabilitation regime that includes early active exercises~     of the replanted digits.~   "
14000|NCT03383627|"~     Diabetes control is often assessed by tests of glucose levels over time, such as the~     glycosylated hemoglobin A1c (HbA1c) and fructosamine. In the later stages of chronic kidney~     disease (CKD) there is limited data available on the utility of these tests. There are~     reasons to believe that the tests may be less accurate in this population. Continuous glucose~     monitoring (CGM) offers an effective method for understanding the totality of glucose~     exposure and incidence of both hyperglycemic and hypoglycemic excursions.~   "
14001|NCT03383614|"~     The study evaluates safety, tolerability, PK and PD of emodepside, after administration as an~     Liquid Service Formulation (LSF), over 10 days, in healthy male Caucasian subjects.~   "
14002|NCT03383601|"~     This study evaluates frequency of exacerbations, respiratory symptoms, physical exercise~     intolerance and abnormal lung functions among participants who use IQOS with heatsticks~     compared to smokers of conventional cigarettes~   "
14004|NCT03383575|"~     The goal of this clinical research study is to learn if enasidenib (AG-221) alone or in~     combination with azacitidine can help to control myelodysplastic syndrome (MDS). The safety~     of this drug will also be studied.~      Any time the words you, your, I, or me appear, it is meant to apply to the potential~     participant.~      This is an investigational study. Enasidenib is not FDA approved or commercially available.~     It is currently being used for research purposes only. Azacitidine is FDA approved and~     commercially available for the treatment of MDS. It is considered investigational to give~     enasidenib and azacitidine in combination for the treatment of MDS. The study doctor can~     explain how the study drug(s) are designed to work.~      Up to 105 participants will be enrolled in this multicenter study. Up to 75 will take part at~     MD Anderson.~   "
14005|NCT03383562|"~     Evaluate the daytime variation of complications in gastric and pancreatic surgery~   "
14006|NCT03383549|"~     Aging is often associated with pathological pathway such as in Mild Cognitive Impairment~     (MCI), and that pathway may be associated to a high risk of dementia.~      Tools for early identification of functional and cognitive decline and effectiveness of~     treatments in counteracting the loss of functionality to preserve MCI subjects autonomy, have~     been widely debated in recent years.~      In literature, the importance of combined cognitive and physical training is also recognized~     (Karssemeijer E, 2017).~      Moving from the above mentioned findings and considerations, the aim of GOAL project is to~     test a newly developed tele-rehabilitation platform to monitor and preserve functional and~     cognitive abilities in individuals affected by Mild Cognitive Impairment (MCI).~      Participants will be enrolled and randomly assigned to the tele-rehabilitation (GOAL group)~     or usual care program (control group). A dedicated application will be developed for the GOAL~     group. Thanks to the application, the participant will access different contents, such as~     serious games to train cognitive abilities (Anguera et al,2013) and physical training video~     lessons to endorse daily activity. Each participant of GOAL group will be provided with a~     tablet, with the application installed on it, and an internet connection (if needed).~   "
14007|NCT03383536|"~     This study will use a neuroeconomic paradigm with state-of-the-art imaging protocols to probe~     abnormal social reward processing underlying social withdrawal in symptomatic trauma-exposed~     women. By also gathering self-report measures of social anhedonia, performance on non-social~     and social reward valuation tasks, and measures of real-world social functioning including~     social network size, we aim to specify how alterations in social reward processing result in~     social withdrawal and functional impairment.~   "
14008|NCT03383523|"~     This study evaluates 2 new immediate release (IR)-tablet formulations of emodepside and they~     will be compared to the oral liquid service formulation (LSF) used in the FIH Single~     Ascending Dose study (DNDi-EMO-001 study) (CT.gov identifier: NCT02661178)~   "
14009|NCT03383510|"~     The aim of this study is to investigate changes in nutrient intake, the human gut microbiota~     and pesticide excretion in urine when shifting from conventional food habits to sustainable~     food habits.~   "
14010|NCT03383497|"~     Multi-center, retrospective observational cohort study in 4 tertiary referral centers in~     Cairo over the period from 2004 to 2016.~      Study population. including all patients with idiopathic Parkinson disease attending.~     Patients were diagnosed in accordance to the United Kingdom - Parkinson Disease Society Brain~     Bank criteria.~   "
14011|NCT03383484|"~     The overall goals of this project are to assess the efficacy of non-pharmacological,~     complementary therapies to improve outcomes in the treatment of women with polycystic ovary~     syndrome (PCOS). The studies proposed herein are designed to assess the efficacy of~     osteopathic manipulative medicine (OMM) in the assessment of sympathetic tone in these women,~     and the effectiveness of non-pharmacologic therapeutic interventions in improving participant~     metabolic, endocrine, reproductive, and psychological health.~   "
14012|NCT03383471|"~     The purpose of this study is to evaluate the efficacy and safety of intraarticular Invossa K~     Injection patients diagnosed with Kellgren & Lawrence grade 2 knee osteoarthritis.~   "
14013|NCT03383458|"~     This study will investigate if nivolumab will improve recurrence-free survival (RFS) compared~     to placebo in participants with HCC who have undergone complete resection or have achieved a~     complete response after local ablation, and who are at high risk of recurrence~   "
14014|NCT03383445|"~     To date, no formal, randomized, prospective, head-to-head comparisons of surgical aortic~     valve replacement (SAVR) versus transcatheter aortic valve replacement (TAVR) have been~     undertaken in the severe aortic stenosis (AS) population with small aortic annuli. Objectives~     of the present study are to compare the hemodynamic performance (incidence of severe PPM and~     ≥ moderate AR) and clinical outcomes (death, stroke, major or life threatening bleeding)~     between TAVR and SAVR in patients with severe AS and small aortic annuli.~   "
14015|NCT03383432|"~     The intrauterine device is a safe, reliable and long-acting reversible contraceptive method.~     Instrumentation of lower genital mucosa during intrauterine device application provokes pain~     because it is highly sensitive to touch. Fear of pain associated with intrauterine device~     insertion is considered a barrier to use this contraception method.~      The classic insertion instructions recommend performing bimanual examination and uterine~     sounding prior to intrauterine device insertion in order to confirm proper determination of~     uterine size and position. The pain during intrauterine device insertion could be due to~     cervical grasping by the tenaculum, traction on the cervical canal, stretching of the~     internal os by the uterine sound or the intrauterine device inserter, and lastly by~     irritation of the endometrial lining by the intrauterine device.~      Many studies investigated the use of various analgesics in different doses and routes of~     administration and found out that it has a significant impact on relieving of associated pain~     Some technical modifications have been emerged in trial to decrease pain during intrauterine~     device insertion. One of them is trans-abdominal ultrasound guided intrauterine device~     insertion which the participant with a full bladder is subjected to intrauterine device~     insertion under ultrasonographic guide without using tenaculum. This method effectively~     decreased the pain and time of intrauterine device insertion.~      A recent method named Uterine Sounding Sparing Approach has been reported very recently in~     literature by Ali et al., 2017. In this method; the sonographer performs T transvaginal~     ultrasound to evaluate the uterine position and the endometrial length in the sagittal view~     of the uterus. The intrauterine device was inserted directly into the uterine cavity without~     using uterine sounding.~      In spite of less pain reported by trans-abdominal ultrasound guided intrauterine device~     insertion (no vulsellum was used), this methods also have some drawbacks, firstly; the full~     bladder may displace the cervix upward making the intrauterine device application not quite~     easy and secondly; this method needs two investigators which may distress the women who~     wondering about this. These two drawbacks may decrease patient's and physician's~     satisfaction. The uterine sounding sparing approach lacks these two drawbacks which make it~     more satisfying.~      From above evidence, there is a strong need to compare the satisfaction rate between the two~     mentioned approaches in trial to answer this question. Up to our knowledge; no randomized~     trial has been conducted or registered to compare the satisfaction rate between two above~     approaches.~   "
14016|NCT03383419|"~     This phase II, multi-center, open-label study will evaluate the safety and efficacy of~     utilizing HCV-positive donors for heart transplant in HCV-negative recipients treated with~     sofosbuvir 400 mg / velpatasvir 100 mg (Epclusa®).~   "
14020|NCT03383367|"~     France is one of the European countries where the incidence of colorectal cancer is the~     highest among cancers for both sexes. Fecal occult blood screening has been implemented since~     2008. However, this screening excludes high risk people who have a 10 to 30 % risk of~     developing a CRC during their lifetime. Colonoscopy follow up of these persons is not~     organized, and it is up to the attending physician to recall the date of the surveillance~     colonoscopy. This results in a poor compliance with the recommendations by these people. A~     postal reminder of the surveillance colonoscopies sent by The French screening organizations~     to the patients should increase adherence to follow-up recommendations. The colorectal cancer~     screening organizations will collects from the hepatogastroenterologists (HGE) informations~     on colonoscopies of people more than 50 years old who live in the Rhone. These informations~     will allow to send a reminder 3 months before the date recommended by the HGE. Participation~     rate and timeliness will be assessed, as well as the severity of the lesions found. A~     medico-economic analysis will also be carried out.~   "
14021|NCT03383354|"~     Emerging evidence suggests that sleep-related disturbances such as sleep-disordered breathing~     (e.g. sleep apnea), sleep fragmentation, abnormal sleep architecture, and periodic limb~     movements (PLMs) are closely linked with adverse health outcomes such as cardiovascular~     events, hospital admissions and mortality. However, data supporting some of these~     associations is inconclusive. The Sunnybrook Health Sciences Centre sleep clinic has~     collected a detailed set of physiological variables from adults who underwent daytime and~     overnight sleep studies at the Sunnybrook Health Sciences Centre Sleep Laboratory from 2004~     till present. Data exists on more than 5,000 subjects with various disturbances of sleep. The~     investigators plan to link the Sunnybrook Sleep Laboratory data with various health~     administrative databases based at the Institute for Clinical Evaluative Sciences (ICES). The~     primary objective of this study is to determine whether the presence of various findings on~     polysomnography (e.g. obstructive sleep apnea, sleep structure / fragmentation, physiological~     characteristics such as arousals and periodic limb movements in sleep) are associated with~     different adverse health outcomes such as cardiovascular events, cancer, depression, hospital~     admissions, emergency department visits and mortality.~   "
14022|NCT03383341|"~     Edible insects are often considered a nutritious, protein-rich, environmentally sustainable~     alternative to traditional meat. They represent a new food for North American consumers.~     While the nutrient composition of several insects is characterized, all potential health~     impacts have not been evaluated. Crickets contain chitin and other fibers that may influence~     gut health. In this study, we evaluated the effects of consuming 25 grams/day whole cricket~     powder on gut microbiota composition, while assessing safety and tolerability. Twenty healthy~     adults participated in this six-week, double-blind, crossover dietary intervention.~     Participants were randomized into two treatment arms and consumed either cricket-containing~     or control breakfast foods for 14 days, followed by a 14-day washout period and assignment to~     the opposite arm. Blood and stool samples were collected at baseline and after each treatment~     period to assess liver function and microbiota changes. Results demonstrate that cricket~     consumption is tolerable and non-toxic at the treatment dose. Cricket powder supported growth~     of the probiotic bacteria, Bifidobacterium animalis, which increased more than 5.7-fold.~     Cricket consumption was also associated with reduced plasma TNF-a. These data suggest that~     eating crickets may improve gut health and reduce systemic inflammation; however, more~     research is needed to understand these effects and underlying mechanisms.~   "
14023|NCT03383328|"~     The purpose of this study is to investigate which anti-inflammatory treatment is best at~     preventing postoperative inflammation following cataract surgery. We want to compare topical~     prophylaxis with NSAID eye drops to topical prophylaxis with a combination of NSAID and~     prednisolone. We also want to compare topical prophylaxis with eye drops to drop-less surgery~     where the anti-inflammatory drug is administered to the subtenonal space at the conclusion of~     the surgical procedure. In addition, we want to investigate if topical anti-inflammatory~     prophylaxis should be initiated preoperatively or postoperatively. The primary outcome is~     change in central macular thickness, measured by optical coherence tomography, 3 months after~     surgery.~   "
14024|NCT03383315|"~     Tramadol is widely used as analgesic in trauma patients. However, it causes side effects,~     most notably nausea and vomiting. This study aim to determine the role of prophylactic~     metoclopramide in preventing tramadol induced nausea and vomiting.~   "
14025|NCT03383302|"~     This is a single arm, multi-centre, phase II open label study of nivolumab with stereotactic~     body radiotherapy (SBRT) for early stage non-small cell lung cancer.~      SBRT will be delivered in either 3 or 5 fractions. A flat dose of 240 mg nivolumab infusion~     will begin after the final fraction of SBRT, within 24 hours and typically on the same day.~     Nivolumab will subsequently be given every 2 weeks at a flat dose of 240 mg until 1 year of~     total treatment unless any study drug discontinuation criteria are met.~      Assessment of toxicities will be performed at each clinic visit during treatment, at 30 days~     after the final nivolumab infusion and until 100 days after the final nivolumab infusion.~     Changes in spirometry values and PFTs will be assessed throughout the trial.~      Relapse rates will be assessed with staging CT scans at 3, 6, 12, 18 and 24 months post SBRT.~      An exploratory assessment will be made of the effect pre-treatment pulmonary function tests~     (PFTs) have on outcome measures.~   "
14026|NCT03383289|"~     Resident-to-resident elder mistreatment (R-REM) is a significant problem in long-term~     services and support settings (LTSS), and likely to cause physical and or psychological~     distress. The proposed project tests an intervention developed for use by LTSS staff. As~     such, it represents an important step in the process of developing approaches for~     ameliorating and preventing R-REM in assisted living residences which house residents with~     dementia and related behavioral disorders, and is thus likely to have significant public~     health impact.~   "
14027|NCT03383276|"~     The purpose of this study is to assess the safety and tolerability of ocular administration~     of Topical Interleukin-1-Receptor Antagonist in healthy volunteers. Additionally, the PK of~     Interleukin-1-Receptor Antagonist will be assessed.~   "
14028|NCT03383263|"~     The objective of this study is to assess persistence, adherence and changes in disease~     activity in the children population of juvenile arthritis patients treated with adalimumab~     (HUMIRA®) in the routine clinical settings in the Russian Federation.~   "
14045|NCT03383042|"~     Clinical trial to investigate the safety, tolerability and pharmacokinetics and~     pharmacodynamics of JP-1366 oral administration in healthy male subjects~   "
14029|NCT03383250|"~     The investigators have recently shown that postprandial sensations correlate with changes in~     circulating metabolites after a meal ingestion; however this phenomenon was demonstrated with~     a meal load up to the level of tolerance which involved an unpleasant fullness sensation. The~     aim of the present study is to determine changes in circulating metabolites of a satiating~     pleasurable meal. Healthy men (n = 32) will be evaluated after a 5 h fast. Perception~     measurements and blood samples will be taken before and 20 minutes after ingestion of a~     palatable probe meal (juice and warm ham and cheese sandwich, total 300 ml, 440 kcal). NMR~     spectroscopy will be performed to determine plasmatic Low Molecular Weight Metabolites (LMWM)~     and to characterize lipoprotein profiles (number of particles, lipid content and size of the~     main three lipoprotein classes (VLDL, LDL and HDL). Homeostatic (satiety, fullness) and~     hedonic sensations (digestive well-being, mood) will be measured by 10 cm analogical scales.~   "
14030|NCT03383237|"~     The purpose of this study is to confirm the safety and efficacy of Apatinib as the~     Second-line Therapy in Malignant Melanoma.~   "
14031|NCT03383224|"~     It has previously been shown that patients with coronary artery disease may have a harder~     time quitting smoking if they have a specific genetic profile and that these individuals have~     a better chance at quitting if they receive nicotine replacement therapy. The investigators~     hypothesize that determining which individuals with coronary artery disease should receive~     nicotine replacement therapy based on their genotype may improve the number of individuals~     who are able to quit smoking.This study randomizes treatment to that determined by the~     patient's genotype compared to standard, non-genotype-guided, treatment.~   "
14032|NCT03383211|"~     Maternal infections affect the basal immune status of neonates. One of the possible mechanism~     is the fetomaternal microchimerism, in which some cells and active substances are exchanged~     bi-directionally between maternal and fetal circulation through placenta. Even in the absence~     of a direct (vertical) transmission of pathogens to fetuses, certain infections make the~     neonates more prone to allergies and some adverse events of early vaccinations. We postulate~     that the basal immune status of neonates born to HIV and LTBI infected mothers is primed by~     gestational exposure to immunological active molecules, which could results in an altered~     response to early BCG vaccination. Transcripts expression identified by RNA sequencing are~     compared between sets of mother-child and their respective umbilical cord blood, and between~     groups of infected and non-infected pairs.~   "
14033|NCT03383198|"~     This is a randomized controlled pilot study evaluating length of pain control with either~     liposomal bupivacaine or with bupivacaine plus decadron after PEC II injection in patients~     having bilateral mastectomies with immediate reconstruction.~   "
14034|NCT03383185|"~     Evaluation of metabolic profile of users of hormonal and non-hormonal contraceptives during~     five years follow-up~   "
14035|NCT03383172|"~     Mental health in Chilean children and families is an urgent public health problem. Prevalence~     of psychiatric disorders among children between 4 and 11 years old is 27.8%, a higher~     percentage than was found in adolescents between 12 and 18 years old, which is 16.5%. The~     most frequent disorders in the population between 4 and 11 years old were disruptive~     disorders (20.6%), followed by anxiety disorders (9.2%). Mental health problems generate a~     high burden of disease on society in general; and there is an important treatment gap,~     especially among economically vulnerable populations. Prevention strategies appear to be the~     more recommendable options, mainly if these interventions can be implemented early in life~     and at low cost. Few preventive interventions aiming to increase resilience in the face of~     adversity, have been rigorously evaluated in Chile among preschoolers. There is substantial~     international evidence that shows that strengthening basic psychological skills, such as~     emotion regulation and social problem-solving, can reduce the incidence of mental pathology~     and improve various academic indicators. The curriculum of the Interpersonal Cognitive~     Problem Solving Program, also known as I Can Problem Solve (ICPS), is focused on the~     development of the cognitive process and children's social problem-solving skills. ICPS has~     been found to be effective in increasing pro-social behaviours and reducing aggressive~     behaviour among preschoolers. No previous studies in Spanish-speaking Latin American~     countries have been conducted aiming to explore the acceptability and feasibility of ICPS to~     provide information to evaluate later the effectiveness of this intervention at a larger~     scale.~      The main objective of this study is the evaluation of the acceptability and feasibility of an~     adapted version of ICPS in the national context at educational institutions with high~     socio-economic vulnerability, with the ultimate goal of increasing social-emotional~     competence and reducing emotional and behavioural problems in preschoolers.~   "
14036|NCT03383159|"~     Patients with colorectal cancer are known to be at high risk of developing metachronous~     adenoma, however, participation in colonoscopy are low. Colonoscopy, the primary modality~     used all over the word, is costly and invasive, and its efficacy depends on the endoscopist's~     skill and the patient's bowel preparation. As life expectancy of patients with history of~     colon cancer is increasing, colonoscopy would increase the overall cost for patients and for~     the health care system. This study aim to construct a predictive model of postoperative~     colorectal neoplasm development using microbiota analysis.~   "
14037|NCT03383146|"~     A 52-week study to compare the efficacy of relamorelin with that of placebo in participants~     with diabetic gastroparesis (DG) with respect to the core signs and symptoms of diabetic~     gastroparesis.~   "
14038|NCT03383133|"~     The study test whether the NSAID allosteric site of human sulfotransferase 1A1 (SULT1A1) is~     operative in humans. The study will test the effects of mefenamic acid (MEF) on the~     sulfonation of acetaminophen (APAP, a SULT1A1 specific substrate) and dehydroepiandrosterone~     (DHEA, a SULT2A1 substrate). If the allosteric site is active in vivo, MEF is predicted to~     result in a decrease in sulfonation of APAP (MEF inhibits SULT with high affinity (Ki = 23~     nM), and to have no effect on sulfonation of the DHEA (MEF has little or no effect on SULT2A1~     activity).~   "
14039|NCT03383120|"~     The primary objective is to evaluate the clinical and patient-centered outcomes of~     non-surgical mechanical debridement with adjunctive repeated diode laser application (test)~     in comparison with conventional surgical treatment and adjunctive systemic antibiotics~     (control), for treatment of peri-implantitis lesions, following an observation period of one~     year.~   "
14040|NCT03383107|"~     Exposure to radiation can impact immune cells that are present in the blood, such as~     lymphocytes. It is hypothesized that larger radiation fields and/or longer courses of~     radiation, result in greater decrease in immune cells. To test this hypothesis, investigators~     will take blood samples from subjects undergoing two different standard of care radiation~     regimens for prostate cancer, and subjects undergoing two different standard of care regimens~     for breast cancer.~   "
14041|NCT03383094|"~     The purpose of this study is to compare any good or bad effects of using pembrolizumab (an~     experimental drug) and radiation therapy (RT), compared to using cisplatin chemotherapy and~     radiation therapy (RT) in the treatment of patients with head and neck squamous cell~     carcinoma (HNSCC).~   "
14046|NCT03383029|"~     The purpose of this study is to learn more about the eating behaviors of children with~     chronic food refusal. Specifically, investigator's aim to see how the integrated Eating~     Aversion Treatment (iEAT) may affect a child's food consumption. The manual is a structured~     multidisciplinary treatment, including a psychologist and dietitian with consultation from a~     speech-language pathologist. The treatment is designed to increase the volume of foods a~     child eats and decrease their reliance on a feeding tube or formula. The manual includes~     informational handouts, data collection forms, and instructions to guide the increase in~     feeding demands while reducing reliance on formula to meet a child's nutritional needs.~      Children with chronic food refusal will participate in this study at the Marcus Autism~     Center. All children who enroll will receive the iEAT treatment. This involves 10 bi-weekly~     sessions that last approximately one hour, over the course of 5 months and a 1 month~     follow-up visit. Therefore, the study will last a total of 6 months.~   "
14047|NCT03383016|"~     The risk of prostate cancer is associated with lifestyle habits, such as diet and physical~     activity. Indeed, results of numerous studies suggest links between obesity, diabetes,~     inflammation and androgen and estrogen metabolism in the pathogenesis of prostate cancer.~      The goal of BIOCaPPE study (Biomarkers and Prostate Cancer/ Prevention and Environment) is to~     identify biomarkers of prostate cancer risk that are potentially modifiable by environmental~     exposures (e.g. diet and physical activity).~      A selection of few of the most promising biological markers will be evaluated in a cohort of~     more than 3000 men at high-risk of prostate cancer.~      Such biomarkers would provide a practical approach to identify men at high risk of prostate~     cancer who could benefit from interventions aiming at reducing their risk. The biomarkers~     would also be useful to monitor the efficacy of the interventions on patient's lifestyle.~   "
14048|NCT03383003|"~     The Asian-Pacific Consensus Report has recommended that proton pump inhibitor~     (PPI)-clarithromycin-amoxicillin or metronidazole treatment for 7 to14 days is the first~     choice treatment for H pylori infection. As a general rule for the treatment of other~     infectious diseases, clinicians should prescribe therapeutic regimens that have a~     per-protocol eradication rate ≥ 90% for anti-H pylori therapy. However, the eradication rate~     of the standard triple therapy has generally declined to unacceptable levels (i.e., 80% or~     less) recently. The reasons for this fall in efficacy with time may relate to the increasing~     incidence of clarithromycin-resistant strains of H. pylori. Clarithromycin resistance is the~     major cause of eradication failure for stand triple therapy. Standard triple therapies should~     be abandoned in the areas with clarithromycin resistance ≥ 20% because the per-protocol~     eradication rates of standard therapies are often less than 85% and the intention-to-treat~     eradication rates are usually less than 80%..7-10 day non-bismuth containing quadruple~     therapy (Concomitant therapy) had been successful in the presence of clarithromycin~     resistance. Another novel treatment with 14-day high dose PPI and amoxicilin dual therapy~     could also attained >90 eradication rate in some studies. This novel treatment is simple and~     involved only two drugs and the most important of all is that amoxicillin resistance is still~     0% in Taiwan . High dose PPI has been used in several studies for H. pylori eradication in~     order to increase the intra-gastric PH for optimal eradication So far, there is still unclear~     which one is the best first-line H. pylori eradication regimen with highest eradication rate~     and least adverse effects. We therefore design a randomized controlled trial to~     simultaneously assess the efficacy novel 14-day high dose dual therapy by comparing to the~     7-day non-bismuth containing quadruple therapy in Taiwan and to investigate the host and~     bacterial factors predicting the treatment outcomes of eradication therapies.~   "
14049|NCT03382990|"~     The benefit of a drug-eluting stent (DES) in patients with acute myocardial infarction (AMI)~     is controversial. This study will aim to observe the effect of a DES on the risk of new-onset~     AF in patients with AMI.~   "
14050|NCT03382977|"~     The purpose of this study is to assess the safety and tolerability of VBI-1901 in subjects~     with Recurrent GBM.~   "
14051|NCT03382964|"~     Randomized, observer-blinded, multicenter, dose-escalation Phase 1 clinical study~     investigating three dose levels of VLA1553 after a single immunization.~      120 study participants will be enrolled into the study to receive three different doses (30~     subjects in the low and medium and 60 subjects in the high dose group). Vaccination will be~     given intramuscularly on Day 0. As safety precaution, the study will begin with enrolment of~     20 sentinel subjects in an open-label fashion. Thereafter, subjects will be enrolled in a~     blinded, randomized manner in the three study arms.~      A re-vaccination will be given at Month 6 or Month 12 to confirm that a single vaccination~     will be sufficient to induce high titer neutralizing antibodies and protect subjects from~     CHIKV viremia.~      Study participants will be followed up until 13 months after initial vaccination.~   "
14052|NCT03382951|"~     Children's screen media use has been identified as a prominent cause for sedentary time that~     has been linked to obesity and metabolic syndrome, as well as other unwanted physiologic,~     psychosocial, and academic outcomes in children. However, no system that is automatic,~     accurate and unobtrusive has been developed to assess children's screen use on different~     platforms. Advances in technology, such as person detection, accurate facial recognition~     based on images, and imaging, computer vision and signal processing algorithms now offer~     novel and promising solutions to objectively and automatically measure people's screen~     viewing behaviors. Investigators will leverage these recent advances and integrate them to~     develop a first of its kind, in-home, unobtrusive, automatic, privacy preserving screen use~     monitoring system: Family Level Assessment of Screen use in the Home (FLASH) that uses an~     embedded computing platform connected to a video camera on larger, stationary screens~     (FLASH-TV); or functions as a background app using a front facing camera (FLASH-Mobile). The~     trans-disciplinary group, consisting of behavioral researchers at Baylor College of Medicine~     (BCM) and electrical engineers at Rice University, will develop and asses the validity of the~     FLASH to accurately identify whether and for how long a child is using screen media devices.~     In this multiple-PI study, the development of FLASH is led by engineers at Rice. Once a final~     system has been developed, alpha and beta tested, a validation study will take place in~     observation labs by the BCM behavioral researchers with 6-10 year old children for FLASH-TV~     and FLASH-Mobile (n=43). Comparisons of FLASH output will be made to staff observations of~     children participating in a set of structured predefined activities. Next FLASH will be~     assessed for feasibility and accuracy for identifying children's screen use across platforms~     in a naturalistic home setting (n=46), compared to direct observation and screen use diaries.~     FLASH has the potential of having a significant impact on public health and clinical research~     regarding screen media use by improving scientist's ability to assess the children's screen~     use. This can lead to better methodology to understand the impact of screen use on children's~     health outcomes or intervention effects of screen media reduction programs.~   "
14053|NCT03382938|"~     The effects of four different wound infiltration protocols in cesarean section will be~     investigated on parturient' pain intensity, PCA morphine consumption given, side effects and~     parturient' overall satisfaction.~      One group will receive for wound infiltration dexmedetomidine, the second ropivacaine, the~     third dexmedetomidine combined with ropivacaine, while the last one will receive normal~     saline (placebo group).~   "
14054|NCT03382925|"~     Does low-does cervical epidural lidocaine cause transient weakness?~   "
14055|NCT03382912|"~     To compare the efficacy of AM0010 in combination with nivolumab versus nivolumab alone in~     patients with metastatic Non-Small Cell Lung Cancer as measured by objective response rate~   "
14056|NCT03382899|"~     To compare the efficacy of AM0010 in combination with pembrolizumab versus pembrolizumab~     alone in patients with metastatic Non-Small Cell Lung Cancer as measured by objective~     response rate~   "
14059|NCT03382860|"~     The purpose of this pilot study is to assess whether the intracranial pressure (ICP) can be~     detected by using a non-invasive retinal fundus scanner, recording the vessels of the eye~     entering from the optic disc. The artery's diameter (A) is measured and compared to the~     vein's diameter (V) thereby a ratio A/V can be calculated. This ratio is compared to the~     values obtained from conventional fiberoptic intraparenchymal, intraventricular ICP~     monitoring using external ventricular drain (EVD) or lumbar pressure monitoring.~      Valid non-invasive techniques for objective measurements of the intracranial pressure do not~     exist at the given time now and this study could prove to help the development of monitoring~     patients ICP without surgical intervention.~   "
14060|NCT03382847|"~     Study subjects active on the waiting list for a heart transplant at the NYU Langone~     Transplant Institute who are hepatitis C (HCV) negative will receive a heart transplant from~     a donor who tests positive for HCV. The study will entail surveillance for the development of~     HCV viremia post-transplant. Patients who develop HCV viremia post-transplant will be treated~     with an FDA-approved, pan-genotypic direct acting antiviral drug, Mavyret. Patients who are~     treated with Mavyret will be monitored for clearance of viremia and for sustained virologic~     response.~   "
14061|NCT03382834|"~     This study will evaluate the effects of tamoxifen exposure in combination with vorinostat on~     viral reactivation among HIV-1 infected post-menopausal women with virologic suppression on~     antiretroviral therapy (ART), when compared to vorinostat alone.~   "
14062|NCT03382821|"~     Do cervical epidural steroid injections done by transforaminal catheter targeted approach~     improve pain and function in patients with cervical radicular pain?~   "
14063|NCT03382808|"~     Impaired recognition of affective facial expressions has been conclusively linked to~     antisocial and psychopathy. However, little is known about the modifiability of this deficit.~     This study aims to investigate whether and under which circumstances the proposed perceptual~     insensitivity can be addressed with a brief implicit training approach.~   "
14064|NCT03382795|"~     In this trial, treatment efficacy and safety of retreatment with 1st generation epidermal~     growth factor receptor(EGFR) tyrosine kinase inhibitor(TKI)s(Gefitinib/Erlotinib), will be~     assessed in patients with sensitizing EGFR mutation positive Non-Squamous Cell Carcinoma~     patients who previously treated with EGFR TKI and cytotoxic chemotherapy~   "
14065|NCT03382782|"~     People with serious mental illness such as schizophrenia and bipolar disorder experience high~     rates of physical illness and die earlier than people without serious mental illness (WHO,~     2005). Health differences seem to be worse among African Americans (Weber, Cowan, Millikan &~     Niebuhr, 2009). High rates of obesity among this group contribute to health and wellness~     concerns (de Hert et al., 2011), with African American women at higher risk of obesity than~     men. Behavioral weight loss interventions (BWLIs) may promote diet and physical activity that~     lead to weight loss, but healthy food and safe physical activity options are less available~     in low-income neighborhoods. Peer navigators have been found to be effective in addressing~     health differences, and may help people living in low-income communities find healthy food~     and activity resources (Fischer, Sauaia, & Kutner, 2007). In addition, traumatic experiences~     are common among persons with serious mental illness as well as African Americans, and may~     impact weight.~      Through this project, investigators will test two interventions designed to address~     overweight and obesity among African Americans with serious mental illness. The first is a~     BWLI designed for persons with serious mental illness and adapted to meet the needs of~     African Americans. This program has 6-month intervention phase and 2-month maintenance phase,~     which includes group weight management classes, group physical activity, individual visits to~     address barriers to meeting weight goals, and weigh-ins. The second intervention is a peer~     navigator program that assists people with serious mental illness in meeting their health~     needs in the community. Two-hundred and seventy (270) research participants will be recruited~     and randomly assigned to one of three conditions: BWLI program, BWLI program plus peer~     navigator, and treatment as usual (integrated physical and mental health care). Investigators~     will evaluate these interventions over an 18-month period, and will track weight change,~     health behaviors, physical and mental health, recovery, and quality of life. Investigators~     also seek to understand the impact of gender and trauma on outcomes. Investigators~     hypothesize that peer navigators will improve outcomes over the BWLI program alone. Findings~     will advance knowledge and services to reduce racial disparities in obesity and comorbid~     health conditions for African Americans with serious mental illnesses.~   "
14066|NCT03382769|"~     This is a prospective, 1:1 randomized controlled trial of immediate versus delayed cochlear~     implantation (CI) on hearing handicap, communicative function, loneliness, mental wellbeing,~     and cognitive functioning. Participants are randomized 1:1 to an immediate cochlear implant~     intervention group versus a hearing aid control intervention.~   "
14067|NCT03382756|"~     A cross-over, randomized and open-label clinical trial to evaluate the effects of food on the~     bioavailability of CKD-337 after a single oral dose in healthy male subjects~   "
14068|NCT03382743|"~     lidocaine spray is used endocervical before office hysteroscopy to reduce the pain~   "
14069|NCT03382730|"~     The objective of the CHORAL study is to evaluate the de-adoption of oral chlorhexidine and~     the introduction of a bundle of oral care practices on selected outcomes in critically ill~     mechanically ventilated adults.~   "
14070|NCT03382717|"~     This study evaluates the effect of the medical device Excilor® Forte in the treatment of~     toenail onychomycosis. Half of the participants will receive the tested product and the other~     half will receive a comparator (Amorolfin 5%). Patients will be followed during 6 months.~   "
14071|NCT03382704|"~     Skin cancers around the eye are common, but so are other lid lumps. It is useful to be able~     to tell which lumps are likely to be cancer.~      This study looks at whether the loss of fine hairs (lanugo hairs) on the skin are a good~     indicator of whether a lump is a skin cancer or not.~      The investigators are recruiting patients who have lid lumps who haven't had a biopsy before,~     who would be having a biopsy as part of their treatment, and seeing whether those who have~     loss of the fine skin hairs are the same as those who have skin cancer confirmed on their~     biopsy.~      The study doesn't involve any extra examinations or treatments for participants. The~     investigators look at the patients before the biopsy as part of their usual care, and take a~     note of whether or not they have lost the fine hairs at this stage.~      The main benefit of participating is that the medical community has better evidence about~     which lid lumps are likely to represent skin cancer, helping future diagnosis.~      There are no additional risks to participating. The risks of biopsy are unchanged whether~     patients participate in the study or not.~      The study is run from the Princess Alexandra Eye Pavilion in Edinburgh, in conjunction with~     Moorfields Eye Hospital, London~      The investigators aim to start the study in Spring 2018, and will most likely recruit for 6~     months depending on the number of participants recruited.~      There is no additional funding from any source at present - the work will be undertaken by~     doctors in their research time.~   "
14072|NCT03382691|"~     The accuracy and safety of blood pressure module of new mobile device (M- HEALTHCARE device)~     is evaluated according to Korean FDA guidelines in 100 healthy volunteers.~   "
14077|NCT03382626|"~     Traumatic Brain Injury (TBI) is a serious public health problem due to its high mortality and~     morbidity rates, mainly affecting young adult males. Aggression to the prefrontal cortex,~     caused by an external physical force, responsible for anatomical injury and/or functional~     impairment, causes cognitive deficits with important consequences for the individual affected~     by the trauma and their caregivers. Therefore, rehabilitation is of utmost importance. The~     increase in pre-frontal cortical activation through training, activity-dependent stimulation~     and neuroplasticity, especially in the dorsolateral prefrontal cortex (DLPFC) is related to~     better performance in functional memory. In this context, Transcranial Direct Current~     Stimulation (tDCS), intended to drive neuroplastic changes in the brain, has been widely used~     to bring benefits to the cognitive function of individuals affected by various neurological~     conditions, including TBI by promoting neuroplasticity for critically involved cortical areas~     in the performance of tasks, culminating in cognitive benefits. In addition, studies have~     shown greater benefits when the technique is combined with cognitive training. Therefore, the~     objective of this parallel, randomized, double-blind, placebo-controlled clinical trial is to~     investigate the effect of tDCS applied on the dorsolateral prefrontal cortex and virtual~     reality cognitive training alone or in association with tDCS on cognitive function of~     individuals with severe chronic TBI.~   "
14078|NCT03382613|"~     The purpose of this study is to evaluate the impact of a hospital quality improvement (QI)~     program on the use of guideline-recommended oral anticoagulants (OAC) in hospitalized~     patients with atrial fibrillation (AF) at risk for ischemic stroke. Specifically, the study~     will determine whether the intervention, compared to Usual Care, will result in a greater~     increase in the proportion of patients with AF at risk for ischemic stroke who are~     appropriately treated with OAC.~   "
14079|NCT03382600|"~     The purpose of this study is to estimate overall response rates (ORRs) of pembrolizumab +~     oxaliplatin + TS-1 and pembrolizumab + cisplatin + TS-1, as first-line treatment for gastric~     cancer in programmed death-ligand 1 (PD-L1) positive, human epidermal growth factor receptor~     2 (HER2/neu)-negative participants with advanced gastric or gastroesophageal junction (GEJ)~     adenocarcinoma.~   "
14080|NCT03382587|"~     The purpose of this observational study lies in the analysis of a treat-and-extend injection~     scheme with intravitreal aflibercept (i.e. injection into the eye), as applied in routine~     practice in previously untreated patients diagnosed with wet age-related macular~     degeneration.~   "
14081|NCT03382574|"~     This randomized pilot clinical trial studies how well denosumab works in BRCA1/2 mutations~     carriers scheduled for risk-reducing salpingo-oophorectomy. Monoclonal antibodies, such as~     denosumab, may interfere with the ability of tumor cells to grow and spread and may block the~     development of cells that break down bone.~   "
14082|NCT03382561|"~     This randomized phase II clinical trial studies how well cisplatin, carboplatin, and~     etoposide work when given together with nivolumab in treating patients with extensive stage~     lung cancer. Drugs used in chemotherapy, such as cisplatin, carboplatin, and etoposide, work~     in different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as~     nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving~     cisplatin, carboplatin, and etoposide together with nivolumab may work better in treating~     patients with extensive stage lung cancer.~   "
14083|NCT03382548|"~     Intensive care units (ICUs), with high antibiotic consumption, are epicentres of~     antimicrobial resistance (AMR). Ventilator associated pneumonia (VAP) is the commonest~     hospital-acquired infection (HAI) in ICUs and is associated with a high morbidity and~     mortality in these vulnerable patients despite antibiotic therapy. No well-designed clinical~     trials studying antibiotic duration for VAP caused by predominantly non-fermenting~     Gram-negative bacteria have been conducted to date. Shortening antibiotic duration has the~     potential to improve individual patient outcomes and indirectly benefit other patients by~     reducing the selection pressure for multidrug resistant (MDR) bacteria within the ICU.~      This study aims to show non-inferiority of short antibiotic treatment duration (7 days or~     less) versus long antibiotic therapy (8 days or more) for VAP. Patients who have been~     ventilated for more than 48 hours will be screened daily for signs and symptoms of VAP~     according to the US Centers for Disease Control and Prevention VAP criteria. Recruited~     patients will be reviewed daily for clinical signs of stability including temperature <38°C~     for 48 hours, systolic blood pressure >90mmHg without inotropes. Recruited patients will be~     randomised once they fulfill these clinical criteria of stability. In the intervention arm,~     antibiotics should be stopped within 7 days once the above criteria are fulfilled. In the~     control arm, antibiotics should be at least 7 days with the exact duration decided by the~     managing physicians.~      The primary outcome of the study is a combined endpoint of mortality and VAP recurrence at~     day 60 of recruitment. The study hypothesis is that a shorter duration of treatment for VAP~     (7 days or less depending on clinical response) is noninferior to a longer duration (8 days~     or more). The secondary outcomes of the study include clinical parameters such as rate of~     acquisition of MDRO hospital-acquired infections, duration of ventilation and hospitalization~     and days of antibiotics use. The study team will also characterise the microbiome changes in~     study participants according to the type and duration of antibiotics. MDROs collected will~     undergo whole genome sequencing for transmission dynamics study. The study is a multinational~     multicenter study involving hospitals in Asia.~   "
14084|NCT03382535|"~     Two voice therapy methods are compared. Activity noise levels and vocal load of teachers~     during teaching in primary school classrooms are evaluated. Acoustic and Workshop~     Interventions are implemented in order to reduce noise level during lesson.~   "
14085|NCT03382522|"~     Prognostic interest of bone scintigraphy in bone metastatic prostate carcinoma (BMPC) has~     been shown. Recent technological advances allow to perform quantitative bone SPECT-CT in~     routine practice. The aim of this study is to assess the prognostic interest of quantitative~     bone SPECT-CT in BMPC.~   "
14086|NCT03382509|"~     Primary objective mass balance, excretion pathways and metabolism following a single oral~     dose of [14C]BI 1467335 given to healthy male subjects (a selected number of subjects will be~     treated with [14C]BI 1467335 after a preceding 27 days treatment with non-radiolabelled~     compound of BI 1467335 QD) Secondary objectives is to investigate the basic pharmacokinetics~     after single and multiple doses of BI 1467335 and its metabolites~   "
14087|NCT03382496|"~     This study will describe the characteristics of patients initiating nivolumab treatment for~     lung cancer and their outcomes over 3 years in France~   "
14088|NCT03382483|"~     This study is one of three separate studies of the Bioventus Observational Non-interventional~     EXOGEN Studies (BONES) program. Eligibility for each study is determined by fractured bone.~   "
14089|NCT03382470|"~     Antimicrobial resistance is one of the greatest threats to human health, and is driven by~     inappropriate antimicrobial use. Antimicrobial stewardship programs (ASPs) improve the use of~     antimicrobials in hospitals. The purpose of this study is to identify the need for and~     barriers to implementation of ASPs in three hospitals in Sri Lanka, Kenya, and Tanzania.~   "
14090|NCT03382457|"~     Early feasibility study to assess the safety and performance of the Edwards Cardioband~     Tricuspid Valve Reconstruction System~   "
14091|NCT03382444|"~     Patients with failed kidneys need Renal Replacement Therapy (RRT) to remove fluid and toxins~     from the body. The 3 types of RRT are kidney transplant or removal of waste by dialysis,~     either via the blood (haemodialysis) or via the stomach area (peritoneal dialysis). 27,000~     patients currently receive dialysis in the UK and some endure reduced quality-of-life,~     depression, and thinking and memory difficulties. Some of these symptoms reflect undiagnosed~     dementia. Indeed up to 7/10 dialysis patients suffer moderate to severe brain impairment or~     dementia - much more frequently than in the general population.~      This study will assess brain function just before starting dialysis/transplant and at 3 and~     12 months afterwards with face to face assessments and with brain scans in some patients.~     Changes in brain function will be compared between people treated with the different forms of~     dialysis and transplant.~      The Investigators hope to evaluate whether these tests are acceptable to patients, whether~     affected sub-groups with cognitive impairment can be identified early, and if certain~     dialysis methods are better for patients with cognitive impairment/dementia, so that a larger~     study to try to improve brain function after RRT can be developed.~   "
14092|NCT03382431|"~     PC786 is a new medicine being developed for treatment of respiratory syncytial virus. The~     main purpose of this study is to evaluate the antiviral activity of PC786 in healthy adults~     infected with RSV virus in a viral challenge study.~   "
14093|NCT03382418|"~     The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of an~     HIV vaccine (gp145 C.6980) with aluminum hydroxide adjuvant in healthy, HIV-1-uninfected~     adults in the United States.~   "
14094|NCT03382405|"~     This clinical study will assess the safety, reactogenicity and immunogenicity of mRNA-1647~     and mRNA-1443 cytomegalovirus vaccines in healthy adults~   "
14095|NCT03382392|"~     Introduction: About 50-60% of Amyotrophic Lateral Sclerosis (ALS) is characterized by~     hypermetabolism, defined as 10% or more excess resting energy expenditure (REE) compared to~     theoretical values. Harris and Benedict's (HB) formula is the equation mainly used to predict~     REE, but others are also applied in current practice. The present study aimed to assess REE~     in ALS patients compared to control populations and to compare six formulas commonly used to~     predict REE.~      Nutritional assessments were performed in ALS patients and in two control populations without~     hypermetabolism: healthy elderly people (control 1) and patients with non-restrictive-eating~     disorders (control 2). Weight, height and body composition (by bioimpedance analysis) were~     assessed.~      EE was measured (mREE) by indirect calorimetry and calculated (cREE) using HB 1919 and 1984,~     World Schofield, De Lorenzo, Johnstone and Mifflin formulas. Mann-Whitney and Chi2 tests were~     used to compare the equations.~   "
14096|NCT03382379|"~     Methamphetamine use disorder (MUD) is among the costliest and deadliest substance use~     disorders (SUDs) world-wide and is frequently comorbid with other mental health conditions.~     There is no empirically validated medical treatment for MUD. Drug craving is the signature~     aspect of MUD and other substance use disorders and has been associated with continued drug~     use and relapse. The investigators and others have shown that transcranial direct current~     stimulation (tDCS) over dorsolateral prefrontal cortex (DLPFC) can modulate drug craving in~     different SUDs. tDCS is a method of non-invasive brain stimulation and is a low-cost scalable~     technology without any serious side effects that delivers low levels of direct current (0.1-2~     mAmp) transcranially. However, there are significant inter-individual differences in response~     to tDCS, which is not well understood but can have profound impact on efficacy. Meanwhile,~     there are no studies with neuroimaging to show how tDCS affects drug craving. Investigators~     propose the first combined tDCS/functional Magnetic Resonance Imaging (fMRI) study to examine~     the acute effects of tDCS on neural substrates underlying drug induced craving.~   "
14097|NCT03382366|"~     The main scope of the present pilot study is to evaluate the possible association between the~     status of sarcopenia and the risk of fall in osteoporotic postmenopausal women. Forty~     osteoporotic postmenopausal women, previously (pre-recruitment) classified by DXA in 20~     sarcopenic and 20 non-sarcopenic subjects, will be recruited. The investigators will collect~     data on: 1) bone (vitamin D) and muscle (myokines) metabolisms through blood sampling; 2)~     Risk of fall by the OAK device produced by Khymeia; 3) thigh muscle quality through MR.~   "
14098|NCT03382353|"~     By 2030, the global prevalence of Alzheimer's Disease (AD) is predicted to reach 65.7 million~     worldwide. Despite extensive research efforts, a cure for AD has not been identified. Recent~     studies on non-demented individuals have demonstrated the importance of a healthy lifestyle~     (physical exercise, healthy diet) and non pharmacological interventions (diet supplements) to~     delay the onset of the cognitive decline (Vemuri P et al., 2012). Given that AD is a~     multi-factorial disorder, some multi- component interventions at early stages could be the~     best strategy currently available to delay the AD onset. The aim of this study is to~     investigate the effects of combined non-pharmacological interventions, at different levels of~     intensity, on cognitive performance, on basic (hippocampal, brain ventricle volumes and white~     matter lesions) and advanced magnetic resonance imaging (MRI) markers (Resting-state~     Functional MRI, Probabilistic Diffusion Tensor Tractography~   "
14099|NCT03382340|"~     Phase 1 is an open-label, multi-center dose escalation/dose expansion study designed to~     assess the safety, tolerability and pharmacokinetics (PK) for the recommended phase 2 dose~     (RP2D) of IMX-110. The RP2D will be evaluated in a further dose expansion Phase 2a study~     submitted.~   "
14100|NCT03382327|"~     The aim of this study is to assess the benefit of 3D models in the planning of hepatic~     resection by comparing the changes in the surgical plan based on the analysis of conventional~     preoperative images (CT-scan and MRI), compared to the surgical plan based on the analysis of~     3D reconstruction.~   "
14101|NCT03382314|"~     A randomized, open-label, single-dose, crossover study~   "
14120|NCT03382067|"~     Randomized, blind parallel group design. Single intake of 55 g high Epicatechin /Melissa dark~     chocolate containing 160 mg Epicatechin per 55 g serving or single intake of 55 g low~     Epicatechin/ oat bran white chocolate containing < 0,00045 mg Epicatechin per 55 g serving.~      A Total of 128 participants, 64 in each group, approx. equal number of male and female. There~     will be replacement of Drop-Outs until data from 128 participants are completed.~      The primary endpoints will be performance in a pictorial memory task and a verbal memory task~     .~      The secondary endpoints will be performance in a working memory test, Saliva cortisol, Visual~     analog scales assessing, anxiety, confidence, interference, solicitude, and excitement.~   "
14102|NCT03382301|"~     Renal artery stenosis is one the leading cause of secondary hypertension. Previous randomized~     controlled trials in humans have failed to demonstrate an improvement of renal function after~     stenosis dilation, probably because of a selection bias with more severe patients being~     excluded from randomization. Renal ischemia-reperfusion injuries have also not been taken~     into account. Indeed, reperfusion leads to a rapid renal blood flow recovery associated with~     renal ischemia-reperfusion injuries.~      Mitochondrial permeability transition pore (mPTP) is a key player in the occurrence of~     ischemia reperfusion injuries because its opening leads to mitochondria leakage and cell~     death. However, preconditioning whether pharmacological or ischemic can prevent mPTP opening~     and protect cells. Ciclosporin A can prolong mPTP closing during reperfusion and reduce renal~     and cardiac tissular lesions. Another mPTP blocker (Bendavia) has been associated with an~     improvement of renal blood flow (RBF) and glomerular filtration rate (GFR) after renal artery~     stenosis dilation at 6 weeks in pigs. Based on a recent study, dilation overall benefit could~     be secondary to an improvement of the contralateral kidney GFR and tissue oxygen content,~     requiring a single kidney evaluation of those renal functional parameters. The investigators~     previously demonstrated that dose and timing of ciclosporin A preconditioning is key to~     protect kidneys from ischemia-reperfusion injuries. Previous controlled trials that failed to~     demonstrate a benefit of ciclosporin A conditioning have used post conditioning on necrotic~     cells. Considering kidney ischemia-reperfusion injuries, preconditioning have led to more~     encouraging results compared to ciclosporin A post conditioning in animals. Therefore the~     investigators aim to conduct the first clinical study of ciclosporin A preconditioning for~     prevention of kidney ischemia-reperfusion injuries after renal artery stenosis dilation.~      Using renal functional imaging and the new PET-MRI (Positron Emission Tomography-Magnetic~     Resonance Imaging) combined device, the investigators will evaluate kidney perfusion,~     oxidative metabolism, glomerular filtration rate and oxygen content before and 3 months after~     renal artery stenosis dilation with or without a ciclosporin A preconditioning.~   "
14103|NCT03382288|"~     The primary objective of this clinical trial is to assess the clinical performance of the~     investigational device. To that end, for each measure and the in-vivo repeatability will be~     quantified, as well as the mean measurement deviation with respect to the current gold~     standard device. As a secondary objective of the study, raw measurement data will be~     collected, to allow for improvements of existing algorithms, development of additional~     measure and and for retrospective analysis.~   "
14104|NCT03382275|"~     By describing the characteristics of iron deficiency (ID) patients treated with various oral~     or intravenous iron formulations and their outcomes, this registry will provide the medical~     community with important information to support treatment decisions for their patients~     regarding data on effectiveness, safety, tolerability, treatment persistence, quality of~     life, and therapeutic costs. This will ultimately support improvements to patient care,~     including the long‐term outcomes of patients with ID.~   "
14105|NCT03382262|"~     This is an open-label study to compare systemic exposure to triamcinolone acetonide following~     a dose of extended-release FX006 or immediate-release TAcs (triamcinolone acetonide~     suspension) in patients with osteoarthritis of the shoulder (glenohumeral joint) or hip~   "
14106|NCT03382249|"~     Sonodynamic therapy (SDT) is a new treatment for carotid atherosclerotic plaque. The aim of~     this study is to assess the safety and efficacy of this technique.~   "
14107|NCT03382236|"~     This type of study can have an impact on public health policy and help improve the management~     of pain in people with EHPAD; Propose better use of drug treatments and non-pharmacological~     methods such as osteopathy; Help structuring the healthcare sector.~   "
14108|NCT03382223|"~     Dementia affects 10% of the elderly population in Singapore. However, there is a lack of~     systematic information regarding end of life (EOL) care received by patients dying with~     severe dementia (PDSD), PDSD's EOL direct and indirect costs and caregiver burden. This~     study, a first of-its-kind prospective cohort study in Singapore will assess the EOL care~     received by PDSD and PDSD's caregivers, EOL medical and social care costs of severe dementia~     and caregiver burden; and will develop a risk score to predict 6-month mortality for PDSD.~     The investigators will accomplish this by surveying caregivers of PDSD every 4 months till~     the patient passes away and 6 weeks and 6 months after patient's death during caregiver~     bereavement. The investigators will also extract and match patient medical and billing data~     with survey data for comprehensive assessment of care costs.~      Key outcomes achieved by this study will be improved understanding of PDSD's EOL care, EOL~     care costs, and caregiver burden and bereavement. The systematic data collected will also~     lead to predicting 6 month mortality for community dwelling PDSD with greater accuracy~     compared to existing tools. Positive implications from this study will be improved early~     decision making by caregivers regarding EOL care and physician referrals for palliative care~     services; and a better understanding of EOL care for PDSD and PDSD's caregivers that will~     lead to cross-sector collaborations to improve delivery of palliative care to PDSD. In this~     way this proposal is highly responsive to the grant call which focuses on early decision~     making and cross sector palliative care delivery among non-cancer patients. In the long term,~     this study will improve clinical and public health policy and has the potential to be the~     foundation for future initiatives for dementia care and improved social and medical~     infrastructure planning.~   "
14109|NCT03382210|"~     Importance: The Enhanced Recovery Program (ERP) for perioperative care of the surgical~     patient reduces the postoperative metabolic response and organ dysfunction thereby~     accelerating functional recovery. Consequently, the hospital length of stay (LOS) may be~     reduced, with no increase in morbidity and mortality rates resulting in a potential economic~     benefit.~      Objective: To determine impact on postoperative recovery and cost-effectiveness of~     implementing an ERP for colorectal surgery in an Italian academic center.~      Design, Setting, and Participants: A prospective consecutive series of patients (N=100)~     undergoing elective colorectal resection completing a standardized ERP in 2013-2015 (ERP~     group) will be compared to patients (N=100) operated on at the same Italian University~     hospital in 2010-2011 (Pre-ERP group) before introducing ERP program. The exclusion criteria~     are: age>80 years old, ASA score IV, tumour stage IV, and inflammatory bowel disease.~      Exposures: ERP for perioperative care. Main Outcomes and Measures: To evaluate the impact of~     colorectal ERP implementation on hospital LOS proxy of functional recovery. Secondary~     outcomes include: postoperative complications, 30-day readmission and mortality, protocol~     adherence, nursing workload, cost-effectiveness, and factors predicting prolonged hospital~     LOS. Patients' satisfaction in ERP group will also be prospectively evaluated.~   "
14110|NCT03382197|"~     Chronic obstructive pulmonary disease (COPD) is characterized by a poorly reversible airway~     obstruction and consequent systemic manifestations. Its high prevalence and high number of~     diagnosed patients has become a challenge for health services due to the costs of diagnosis~     and treatment of these patients. Positive pressure and aerosol therapy are preferred~     therapies for the management of COPD symptoms, but their effects when associated are poorly~     studied. The objective of this study is to compare the effects of different positive pressure~     strategies associated with aerosol therapy through Pulmonary Scintigraphy and Electrical~     Impedance Tomography (EIT) in patients with COPD in the intercrise period. This is a~     randomized, crossover, blinded and allocated crossover type clinical trial in which patients~     with moderate to severe COPD will be allocated to three intervention groups with different~     strategies for positive pressure associated with aerosol therapy: control group 1~     nebulization), group 2 nebulization with EPAP valve and group 3 nebulization with NIV~     bi-level pressure mode. The radioaerosol deposition pattern will be evaluated through~     Pulmonary Scintigraphy and regional pulmonary ventilation through EIT.~   "
14154|NCT03381625|"~     This is a randomized, placebo-controlled Phase 2 trial consisting of up to 300 subjects with~     either psoriasis or atopic dermatitis. In this trial BMX-010 will be topically applied twice~     daily for up to 28 days.~   "
14111|NCT03382184|"~     This study is being done to evaluate the effects of fractional photothermolysis (known as~     laser resurfacing) using fractional laser for the induction of hair follicles via skin~     rejuvenation in subjects with scalp alopecia (specifically, alopecia on the superior forehead~     at the frontal hairline). Fractional photothermolysis has been shown to be effective in~     promoting hair growth. The investigators will study 50 subjects who will be treated 6-10~     times at 2-4 week intervals. Each participant will have half of their head treated with a~     laser, either Fraxel DUAL 1550 or Halo by Sciton, and the other half of their head will be~     left untreated as a control. Half of the individuals will randomly be assigned to the group~     to be treated with Fraxel DUAL 1550, and the other half will be treated with Halo by Sciton.~     Visual observation and digital, photographic, non-invasive imaging will be used to compare~     the treated and untreated area to assess for differences in hair follicle stimulation rates,~     number and density of hairs.~      As noted above, the types of lasers we plan to use include the non-ablative fractional laser~     settings for the Fraxel DUAL 1550 and Halo by Sciton. A fractional laser is a laser that~     directs an intense burst of laser energy on the skin. The treatment deposits heat deep into~     the dermis to tighten skin and stimulate collagen remodeling. The necrotic (death of cells or~     tissue) injury heals rapidly and adverse effects are few. Laser resurfacing is commonly used~     for rejuvenation of the skin to improve quality, tone, and texture.~   "
14112|NCT03382171|"~     Cancer patients receiving treatment such as chemotherapy experience a variety of symptoms~     that interfere with their appetite and their ability to eat and enjoy meals. Therefore,~     adapting meals in a way that responds to these symptoms might be a good strategy to improve~     patient satisfaction, nutritional status and hence, quality of life. In this vein, the~     investigators hypothesize that meals from FoodforCare at Home will contribute to the quality~     of life of advanced abdominal cancer patients undergoing chemotherapy when compared to usual~     care.~   "
14113|NCT03382158|"~     Pleuropulmonary blastoma (PPB) is a rare malignant neoplasm of the lung presenting in early~     childhood. Type I PPB is a purely cystic lesion, Type II is a partially cystic, partially~     solid tumor, Type III is a completely solid tumor. Treatment of children with PPB is at the~     discretion of the treating institution. This study builds off of the 2009 study and will also~     seek to enroll individuals with DICER1-associated conditions, some of whom may present only~     with the DICER1 gene mutation, which will help the Registry understand how these tumors and~     conditions develop, their clinical course and the most effective treatments.~   "
14114|NCT03382145|"~     Postmenopausal bleeding (PMB) is a common gynaecological complaint, accounting for up to 5 to~     10 % of postmenopausal women being referred to gynaecological outpatient clinic. It also~     comprised of up to 10% of our outpatient gynaecological referral. In general, 60 % of women~     with postmenopausal bleeding have no organic causes identified, whilst benign causes of PMB~     includes atrophic vaginitis, endometrial polyp, submucosal fibroid and functional~     endometrium. However, between 5.7 to 11.5% of women with postmenopausal bleeding have~     endometrial carcinoma, which is the fourth most common cancer among women, therefore, it is~     important to investigate carefully to exclude genital tract cancer.~      A One-stop postmenopausal bleeding clinic has been established since February, 2002 by the~     Department of Obstetrics and Gynaecology, New Territories East cluster (NTEC) aiming at~     providing immediate assessment of women with postmenopausal bleeding in one single outpatient~     clinic assessment. During the visit, a detailed history was taken in regarding the PMB and~     usage of hormonal replacement therapy or herbal medicine. A physical examination was~     performed and a cervical smear was taken if not been taken within a year. Transvaginal~     ultrasound (TVS) was then performed to measure the endometrial thickness (ET), examining~     ovaries then followed by an endometrial sampling. An outpatient hysteroscopy was performed~     only if TVS showed an ET >= 5mm, or an abnormal endometrial appearance or unsatisfactory ET.~     Benign looking endometrial polyp would be removed during the outpatient hysteroscopy if~     possible.~      At the moment, there was very limited local data and lack of the long term result.~     Investigators aim to retrospectively evaluate the clinical outcome of postmenopausal bleeding~     patients who has attended One Stop Postmenopausal Clinic in order to formulate better care~     and counseling in future.~      Objectives:~        1. To analyze histopathology in relative to history and ultrasound findings in PMB women~          presented to One Stop Postmenopausal Bleeding Clinic at NTEC~        2. To correlate the clinical findings of transvaginal ultrasonography (TVS) with outpatient~          hysteroscopy and endometrial assessment in The One Stop Postmenopausal Bleeding Clinic~        3. To identify predictive and prognostic factors in women with PMB for possible use in~          triaging high risk patients~   "
14115|NCT03382132|"~     The purpose of this study is to find out if information and support provided with a~     mobile-delivered (via iPad) momHealth Teen Pregnancy Program can promote healthy choices and~     behaviors during and after pregnancy.~   "
14116|NCT03382119|"~     The goal of this study is to determine if ultrasound tools can be used to detect liver~     stiffness. Acoustic radiation force impulse (ARFI) elastography and backscatter will be used~     to see if they can detect liver stiffness in different populations of patients with liver~     disease.~      The study is measuring liver stiffness in pediatric patients aged 2-5 years. Patients either~     have had a Fontan cardiac surgery or have liver disease.~      Ultrasound scanning takes images of the liver and has much lower risks for patients. ARFI~     elastography and other tools can be used to measure liver stiffness.~   "
14117|NCT03382106|"~     The investigators will study the effect of pulmonary arterial vasodilation to see if it~     eliminates indices of persistent lung injury in smokers that are susceptible to emphysema.~   "
14118|NCT03382093|"~     This project will develop and refine a computer-delivered integrated Personalized Feedback~     Intervention (PFI) that directly addresses smoking and anxiety sensitivity (AS). The PFI will~     focus on feedback about smoking behavior, AS, and adaptive coping strategies.~   "
14119|NCT03382080|"~     Drop out from upper secondary school represents a risk for the future health and wellbeing of~     young people. Strengthening of psychosocial aspects of the learning environment may be an~     effective strategy to promote completion of upper secondary school. The COMPLETE study is a~     school based cluster randomized controlled trial (RCT) evaluating two school-based~     interventions, namely the Dream School Program (DSP) and the Mental Health Support Team~     (MHST) among 1st grade upper secondary school students in four counties in Norway. The~     interventions aim to improve psychosocial learning environments and subsequently school~     achievements and decrease drop-out and absence.~      Specifically, the COMPLETE study will~        1. Evaluate whether the DSP alone~             1. increases completion~             2. increases presence~             3. improves school achievements~             4. improves mental health and wellbeing~        2. Evaluate whether the DSP and the MHST combined~             1. increase completion~             2. increase presence~             3. improve school achievements~             4. improve mental health and wellbeing~           The COMPLETE study will also evaluate the effect of the DSP and MHST combined and the~          DSP alone against secondary outcomes of school satisfaction and loneliness.~        3. Evaluate through a process evaluation whether the interventions were implemented in line~          with guidelines for each of the interventions, and whether the degree of program~          fidelity has influenced the effect of the interventions on the primary and secondary~          outcomes.~   "
14121|NCT03382054|"~     Frailty is prevalent in older adults and may be a better predictor of post-operative~     morbidity and mortality than chronological age. Preoperative risk factors and physiological~     reserves were assessed on patients more than 65 years old who are scheduled for surgery under~     general or regional anesthesia. The aim of this retrospective analysis was to examine the~     impact of relevant geriatric assessments on adverse outcomes in older surgical patients.~   "
14122|NCT03382041|"~     The investigators will compare intramedullary nailing of open and closed tibia shaft~     fractures with carbon fiber implant versus titanium implant in a Level I trauma setting.~   "
14123|NCT03382028|"~     Identification and characterization of the link between psychomotor development and the~     appearance of associated signs in children with Equinus Deformity  considered isolated at~     birth.~   "
14124|NCT03382015|"~     The purpose of this study is to evaluate the effect of BKR-013 on average daily glucose (ADG)~     levels in type 2 diabetes (T2D) subjects during 28 days of either placebo or active test~     product administration. Subjects will serve as their own controls in this crossover design,~     and ADG will be compared while a subject is on active test product versus while they received~     placebo test product.~   "
14125|NCT03382002|"~     Medium of cumulus-oocyte complex will be assessed for oxidative status.~   "
14126|NCT03381989|"~     Background:~      TAVR is a common therapy for people with heart problems. It stands for transcatheter aortic~     valve replacement, TAVR can be a better option than surgery. But it isn t safe for everyone.~     It may block the arteries that supply blood to the heart muscle by pushing heart valve tissue~     outward. Researchers want to study a method that may make TAVR safer. It is known as~     Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary~     Artery obstruction (BASILICA).~      Objective:~      To study the feasibility and safety of BASILICA in people at high risk of coronary artery~     obstruction that complicates TAVR.~      Eligibility:~      People at least 21 years old whose heart doctors do not think they can have TAVR safely~      Design:~      Participants will be screened by a team of heart specialists. They will have heart and blood~     tests. They will answer questions.~      Participants will have TAVR using BASILICA.~      They will get general anesthesia or they will be sedated.~      While using x-rays and ultrasound, doctors will cross and split the aortic valve leaflet with~     tubes and wires.~      A standard TAVR valve will be implanted. Coronary artery stents (metal tubes) will also be~     inserted.~      After the procedure, participants will have blood tests and physical exams. They will answer~     questions. They will have heart tests.~      Participants will have a scan within 1 month and after 12 months. They will have heart tests~     during follow-up visits in the first year.~      Sponsoring Institute: National Heart, Lung and Blood Institute~   "
14127|NCT03381976|"~     This study compared different frequency low-volume resistance training (RT) on total,~     android, gynoid and trunk body fat in obese older women~   "
14128|NCT03381963|"~     The aim of this prospective cohort study is to evaluate the modifications of the biological~     hemostatic profile associated with the use of endocrine therapy in women with breast cancer~     (tamoxifen or aromatase inhibitors).~   "
14129|NCT03381950|"~     Preserving kidney function and improving the transition from CKD to End stage renal disease~     (ESRD) is a research and healthcare challenge. The Chronic Kidney Disease-Renal Epidemiology~     and Information Network (CKD-REIN) cohort was established to identify the determinants,~     biomarkers and practice patterns associated with chronic kidney disease outcomes. The study~     includes 3,033 adult patients with moderate to advanced CKD from a representative sample of~     40 nephrology clinics in France with respect to regions and legal status. Patients are~     recruited during a routine visit and followed up for 5 years, before and after starting renal~     replacement therapy. Patient-level clinical, biological, and lifestyle data are collected~     annually, as well as provider-level data on clinical practices, coordinated with the~     International Chronic Kidney Disease Outcomes and Practice Pattern Study (CKDopps). Blood and~     urine samples are stored in a biobank. The overall objective is to develop a research~     platform to address key questions regarding the determinants and biomarkers associated with~     adverse outcomes in CKD and to assess its effective management. It has the following~     hypotheses and specific aims:~        1. to evaluate a large set of social, environmental, bioclinical, and genetic factors, and~          their interactions in relation with CKD outcomes including progression to ESRD,~          mortality, metabolic and vascular complications, and the onset of a number of chronic~          and acute events;~        2. to assess several new biomarkers to predict adverse outcomes of CKD and its~          complications;~        3. to evaluate the associations of provider practices (management of hypertension, anemia,~          nutritional abnormalities, mineral and bone disorder, nutritional status, timing of~          dialysis initiation and transplant wait-listing) with achievement of clinical practice~          guidelines, clinical and patient-reported outcomes (PRO).~        4. to evaluate the associations of health care organization and clinic services (e.g., for~          nutrition, educational programs) with clinical and patient-reported outcomes, and~          achievement of clinical practice guidelines;~        5. to estimate the relative cost-effectiveness of different provider practices and clinic~          services.~   "
14130|NCT03381937|"~     We want to demonstrate that modifications of the ventilation parameters are liable to improve~     the different characteristics of phonation (duration, intensity, prosody..) in neuromuscular~     patients who are dependent on non invasive ventilation.~   "
14131|NCT03381924|"~     Introduction: Despite the numerous pharmacological treatment options available for migraine~     attacks and for the prevention of thereof, less than 30% of patients with migraine are highly~     satisfied with their current treatment.~      In recent decades, there has been a radical change in the way we view pain, thanks to~     developments in neuroscience. It is currently considered that pain does not originate in the~     peripheral nociceptors, but rather in a network of brain regions (the pain neuromatrix), the~     synchronous activation of which is necessary and sufficient to generate the perception of~     pain. Migraine may be the expression of this exaggerated perception of threat, a perception~     that, from a cultural learning perspective, it may be possible to modify by adjusting beliefs~     and behaviours that favour the onset of an attack.~      The aim of this study was to assess the effectiveness of a group educational intervention~     about concepts of pain neuroscience, in the management of migraine, compared to routine~     medical interventions, in primary care health centres of Alava.~   "
14155|NCT03381612|"~     Female circumcision (FC) is a deeply-rooted practice in Egypt with deblitating physical and~     psychological consequences, however the previous two decades witnessed sincere efforts to~     counterfight this practice. The objective of this study is to investigate the prevalence of~     circumcision among young women (12-25 years) in Beni-Suef , Egypt.~   "
14166|NCT03381469|"~     Aim The Aim of the current study is to establish the association between periodontitis and~     adverse pregnancy outcomes in metabolic syndrome (Mets) patients and to evaluate the effect~     of intervention.~      Objectives~        1. To evaluate the changes in periodontal status of pregnant women with metabolic syndrome~          after non surgical periodontal therapy (NSPT)~        2. To evaluate the inflammatory marker levels in serum of pregnant women with metabolic~          syndrome after non surgical periodontal therapy~        3. To evaluate the effect of NSPT on adverse pregnancy outcomes of women with metabolic~          syndrome~   "
14132|NCT03381911|"~     This study will investigate how consent forms and other health care documents are explained~     to patients. The findings will be used to create a computer program that can successfully~     explain consent and other health-related forms to individuals who have difficulty reading and~     understanding consent forms on their own as a supplement to the normal consent process done~     in research settings.~      In a prior study, the investigators delivered a similar protocol, where subjects were first~     consented and then given a mock consent form (administered in 1 of 3 arms: RA, ECA, or ECA +~     RA). Subjects in this protocol struggled with the concept of a mock consent process,~     especially after they had just completed a consent process for the study itself. The current~     protocol, using deception research methods, aims to provide a more pure assessment of ECA~     consent vs the standard (here, E-consent) by waiving consent and delivering the sham consent~     as if it were reality. In the context of a protocol that employs deception methods,~     participants in the current study would be invited as healthy volunteers, and be randomized~     to 1 of 2 different consent processes to evaluate the relative benefits of different~     approaches for informed consent. After the knowledge tests have been completed, subjects will~     undergo a debriefing where they are made fully aware of the deception and its purpose. At~     that time, subjects will also be given the opportunity to opt out and not have their data~     included in the study results.~   "
14133|NCT03381898|"~     The investigators have developed a three-part allied health care intervention to be delivered~     via telehealth. These interventions are usually provided face-to-face. Telehealth access to~     healthcare is needed for people with Parkinson's disease living in rural locations, where~     providers are sparse and long travel times are often not feasible because of weather~     conditions, as well as the hallmark symptom of Parkinson's disease, movement disorders~   "
14134|NCT03381885|"~     Back pain costs the U.S. over $100 billion annually, and much of this spending is wasteful~     due to the overuse of advanced diagnostic imaging. Despite prominent clinical guidelines and~     the nationally recognized Choosing Wisely campaign discouraging use of costly and low value~     imaging, magnetic resonance imaging (MRI) and computed tomography (CT) studies remain~     frequently overused. Real-time electronic clinical decision support (CDS) at the point of~     care has been increasingly emphasized as an important strategy to improve the value of back~     pain management; however, studies suggest that CDS at best only modestly influences practice~     patterns. The aim is to implement a behavioral economic-based intervention in the ED to~     promote the use of CDS system.~   "
14135|NCT03381872|"~     The aim of the study is to compare clinical outcomes between intravascular imaging-guided~     versus angiography-guided percutaneous coronary intervention (PCI) in complex lesions.~   "
14136|NCT03381859|"~     Primary Efficacy Objective~      -To assess whether a 12-week treatment course with oral 50 mg elbasvir plus 100 mg~     grazoprevir given in a single daily dose to treatment-naïve patients with end-stage renal~     disease (ESRD) and infected with genotype 4 (GT4) chronic HCV (CHC) infection can produce a~     sustained viral response (SVR), i.e. HCV RNA below the lower limit of quantification [LLOQ]~     for 12 weeks (SVR12) after completion of the study treatment course~      Secondary Objectives~        -  To assess the efficacy of elbasvir/grazoprevir in suppressing HCV viremia in~          treatment-naïve GT4 CHC patients at each scheduled visit and clinically meaningful~          endpoints (Week 2, 8 and 12 [End of Treatment - EOT]) and 24 (SVR12)~        -  To assess the safety and tolerability of a 12-week treatment course with~          elbasvir/grazoprevir in treatment-naïve patients with ESRD and infected with GT4 CHC.~        -  To assess liver fibrosis by non-invasive evaluation of liver stiffness (Fibroscan®) in~          the same patients before treatment and EOT and SVR12~      Clinical hypotheses.~      Primary Efficacy Hypothesis~      - A 12-week treatment course with elbasvir/grazoprevir in treatment-naïve patients with ESRD~     and infected with GT4 CHC infection will result in an HCV RNA below the LLOQ in 95% of~     patients within 2 weeks of treatment, and at least 95% will have an SVR12.~      Secondary hypotheses~        -  A 12-week treatment course with elbasvir/grazoprevir in ESRD GT4 treatment-naïve~          patients will result in undetectable viremia in 95% patients at Week 2, 4, 8 and 12~          (EOT) and 24 (SVR12)~        -  Treatment will be safe and well-tolerated in these patients, as determined by the type~          and number of adverse events identified through laboratory testing, vital signs and~          physical examinations.~        -  In these patients with liver fibrosis before treatment, the liver fibrosis as assessed~          by non-invasive evaluation of liver stiffness (Fibroscan®) will improve by EOT and SVR12~   "
14137|NCT03381846|"~     The purpose of this proposed study is to assess effectiveness of MOHS micrographic surgery as~     a form of treatment for dermatofibrosarcoma protuberans in patients who are 10 years of age~     or younger through review of the patients at Mayo Clinic treated from 1988-2017, and to~     explore the challenges that providers face which may prevent them performing this potentially~     superior treatment. This study will provide a comparison of outcomes and recurrence rates in~     pediatric patients treated by MOHS versus traditional excision.~   "
14138|NCT03381833|"~     This study is a Phase 2 multicenter, randomized, open-label, parallel-group study. The~     primary objective of the study is to evaluate the effect of LJPC-401 (synthetic human~     hepcidin) on iron levels in adult patients with transfusion-dependent beta thalassemia with~     myocardial iron overload.~   "
14139|NCT03381820|"~     A randomized controlled trial was conducted in a tertiary care hospital, Khon Kaen province,~     Thailand. Sixty participants were randomized to music listening group and control group. The~     music listening group was assigned to listen to 30-minute instrumental folk music everyday~     for one month. Home BP and office BP were monitored and recorded.~   "
14140|NCT03381807|"~     This project will investigate the safety and effectiveness of human amniotic epithelial cells~     for treatment of severe refractory Asherman's syndrome.~   "
14141|NCT03381794|"~     Aim of this study is to reflect on the changing trends in absolute numbers, surgical~     techniques and indications of corneal transplantations being performed in Germany.~      In 2017, the Section Cornea of the German Ophthalmological Society provides an~     interim-assessment about the most up-to-date results of this long-term study over a period of~     sixteen years between 2001 and 2016.~   "
14156|NCT03381599|"~     The proposed study is a controlled laboratory study where stem cell content of bone marrow~     aspirate will be compared prior to and following pharmaceutical mobilization. Participants~     who meet the inclusion/exclusion criteria will have a bone marrow sample taken from the iliac~     crest. The sample will be tested to determine stem cell content and for the presence of~     proteins which are of interest in orthopedic treatments. Thirty days following the baseline~     bone marrow collection, participants will receive a subcutaneous injection of Filgrastim~     daily for four serial days. On the fifth day, a peripheral blood sample will be taken and~     processed.~   "
14157|NCT03381586|"~     This is a single center, open-label, pharmacokinetic study of ALT-803 administered as a subQ~     injection to healthy volunteers.~   "
14193|NCT03381118|"~     A phase II trial to compare the efficacy and safety of nivolumab and intermediate dose~     cytarabine with or without haploidentical lymphocyte infusion. To identify the role of~     haploidentical lymphocytes in the treatment of acute myeloid leukemia in older adults. The~     patients will be stratified based on the remission number (first or second)~   "
14142|NCT03381781|"~     This is a prospective,uncontrolled and multi-institution trial.The aim is to identify if~     using decitabine,cytarabine and ATO as the therapy of acute myeloid leukemia(AML) with p53~     mutations has better relapse free survival and complete response than using decitabine and~     cytarabine.~      TP53 mutation is commonly associated with poor cancer patient prognosis yet no mutant p53~     (mp53)-targeting regimen was clinically established. Particularly, p53 mutation is associated~     with extremely poor prognosis in myelodysplastic syndromes (MDS) and acute myeloid leukemia~     (AML) patients.~      Decitabine (DAC) is a FDA approved drug for MDS treatment. In two independent clinical trials~     reported recently, DNA demethylating drug DAC treatment yielded a surprisingly high rate of~     complete remission (CR) in mp53-harboring AML/MDS patients (Welch, NEJM, 2016; Chang, BJH,~     2017). Notably, all of the mp53-expressing patients in the two clinical studies relapsed~     quickly.~      Arsenic trioxide (ATO) is a FDA approved drug for M3-AML treatment. Despite of the observed~     efficacy in treating non-APL patients, ATO is not yet approved for non-APL cancer treatment.~     ATO plays key role in regulating both wild-type p53 (wtp53) and mp53. Our published and~     unpublished data suggest ATO potentially hijacks nuclear iASPP-mediated STRaND pathway via~     exposing iASPP's RaDAR nuclear import code (Lu, Cancer Cell, 2013; Lu, Cell, 2014; Lu, Nat~     Rev Mol Cell Biol, 2016; Lu, unpublished). Our unpublished data also suggests a key role of~     ATO in regulating mp53 (Lu, The 17th International p53 Workshop, 2017). ATO is widely~     reported to be able to degrade and thus inhibit mp53's oncogenic function (Hamadeh, BBRC,~     1999)(Liu, Blood, 2003). ATO suppressed cancer cell growth by targeting mp53 for degradation~     by Pirh2 degradation pathway (Yang, JBC, 2011; Yan, PLOS one, 2014);~      Here we explore the potential of combination of DAC and ATO in improving the mp53-harboring~     AML/MDS patients' relapse free survival (RFS) and the ability to thoroughly eliminate mp53~     subclone. Basic researches aiming to explore the mechanisms how mp53 cells responds to DAC~     and/or ATO treatment and how mp53 cells develop resistance to DAC and/or ATO will be coupled.~     We designate trials aiming for a better treatment regimen for mp53 patients as~     'PANDA-Trials'.~   "
14143|NCT03381768|"~     An open phase-1, first-in-human, clinical trial investigating the safety and immunological~     effects of peptide vaccination with Programmed Death Ligand 1 and 2 (PD-L1 and PD-L2)~     peptides in patients with relapsed follicular lymphoma.~   "
14144|NCT03381755|"~     Dual Antiplatelet Therapy (DAPT) with aspirin and P2Y12 receptor inhibitor remains a~     cornerstone in the secondary prevention of coronary artery disease (CAD). Clopidogrel is one~     of the most commonly used antithrombotic agent that inhibits the platelet P2Y(12) adenosine~     diphosphate (ADP) receptor.~      Ticagrelor is an oral, reversibly-binding, direct-acting P2Y12 receptor antagonist used~     clinically for the prevention of atherothrombotic events in patients with acute coronary~     syndromes (ACS). Guideline recommendations on the use of dual antiplatelet therapy have been~     formulated that ticagrelor 90 mg twice daily plus aspirin in preference to clopidogrel 75mg~     daily plus aspirin for ACS patients. The previous studies have reported that half-dose~     ticagrelor had the similar inhibitory effect on platelet aggregation as the standard-dose~     ticagrelor, which was significantly stronger than that in the clopidogrel group. One-quarter~     standard-dose ticagrelor provided greater degree of platelet inhibition than standard dose~     clopidogrel in Chinese patients with stable CAD. But the effectiveness and safety of low-dose~     ticagrelor remain yet not very clearly in Chinese patients with acute coronary syndrome~     undergoing percutaneous coronary intervention.~   "
14145|NCT03381742|"~     Guideline recommendations on the use of dual antiplatelet therapy have been formulated that~     ticagrelor 90 mg twice daily plus aspirin in preference to clopidogrel 75mg daily plus~     aspirin for ACS patients. Recent study found that ticagrelor 90mg twice a day orally could~     significantly reduce the occurrence of clopidogrel resistance and adverse cardiovascular~     events. The previous studies have reported that half-dose ticagrelor had the similar~     inhibitory effect on platelet aggregation as the standard-dose ticagrelor, which was~     significantly stronger than that in the clopidogrel group. One-quarter standard-dose~     ticagrelor provided greater degree of platelet inhibition than standard dose clopidogrel in~     Chinese patients with stable CAD. But large-scale clinical trials are still needed to confirm~     the effects of low-dose ticagrelor on platelet function in Chinese patients with coronary~     heart disease.~   "
14146|NCT03381729|"~     The purpose of this trial is to evaluate the safety and tolerability of intrathecal~     administration of AVXS-101 in patients with Spinal Muscular Atrophy with 3 copies of SMN2~   "
14147|NCT03381716|"~     The study evaluated the prevalence, presentation, management, and prognosis of coronary heart~     disease differ according to sex.~   "
14148|NCT03381703|"~     This study investigates the absorption, metabolism, and excretion and the absolute~     bioavailability of YH12852 in healthy male subjects~   "
14149|NCT03381690|"~     Parturients who undergo emergency Cesarean section (C-sec) after experiencing labor pain are~     likely to develop pain-induced central sensitization. The investigators hypothesized that~     those without epidural labor analgesia undergoing subsequent emergency C-sec would experience~     more severe postoperative pain or require more analgesia after C-sec compared to those with~     epidural labor analgesia. Thus, the investigators conducted this retrospective study by~     grouping parturients undergoing emergency C-sec after experiencing labor pain into two groups~     (epidural labor group and no epidural labor group) and those undergoing elective C-sec aimed~     to compare the effect of epidural labor analgesia on postoperative pain severity and~     analgesic consumption.~   "
14150|NCT03381677|"~     This is a pivotal Randomized Clinical trial to compare the safety and effectiveness of the~     Pedicle Lengthening Osteotomy Procedure with implantation of the Altum® Device to open~     surgical decompression and Transforaminal Lumbar Interbody Fusion (TLIF) in patients with~     symptomatic, one or two level lumbar spinal stenosis (LSS) and one level grade I degenerative~     spondylolisthesis requiring surgical treatment.~   "
14151|NCT03381664|"~     This study will be conducted to evaluate the relative bioavailability, pharmacokinetics,~     safety, and tolerability of AVP-923 (dextromethorphan hydrobromide [DM] and quinidine sulfate~     [Q] capsules) when the contents of a capsule are administered in applesauce or via a~     nasogastric feeding tube, compared with administration of a capsule in healthy, fasting,~     adult participants.~   "
14152|NCT03381651|"~     Esophageal cancer is one of the most common cancers worldwide, while more than half new cases~     and deaths occurred in China. Surgery is the main curative treatment for this disease, the~     5-year survival of EC remains poor, since most diseases are diagnosed at advanced stages.~      In last decades, several large clinical trials and meta-analyses have demonstrated that~     neo-adjuvant chemoradiotherapy followed by surgery can significantly increase the overall~     survival of patients with EC compared with surgery alone, while no effect of nCRT was~     apparent on postoperative health-related quality of life . However, the optimal radiation~     dose and surgery timing are still unknown.~      The investigators hypothesize that patients who receive higher dose (50.4Gy/28F) of~     neoadjuvant chemoradiation will have better pathologic response and progress-free survival~     compared to lower dose (41.4Gy/23F) of chemoradiation followed by surgery.~   "
14153|NCT03381638|"~     Using the Blink Reflexometer, athletes are scanned if they are potentially thought to have a~     concussion during a game or practice.~   "
14158|NCT03381573|"~     This is a retrospective cohort study comparing COPD patients aged 40 years and older with new~     exposure to roflumilast with up to 5 unexposed (ie, not roflumilast-exposed) COPD controls~     matched by propensity score (PS), age, sex, and year of cohort entry. The study is using~     electronic healthcare databases in the US (Military Health System database), Germany (GER)~     (German Pharmacoepidemiological Research Database), and Sweden (SWE) (national databases~     including healthcare, death, and demographics data). The main objective of this study is to~     evaluate the long-term safety of roflumilast in the treatment of COPD with main focus on the~     primary outcome of all-cause mortality and evaluation of potential safety issues identified~     during the clinical trials of roflumilast. Crude mortality and incidence rates will be~     compared between roflumilast exposed and unexposed COPD patients and adjusted hazard ratios~     (HRs) of the primary and secondary outcomes will be calculated.~   "
14159|NCT03381560|"~     No previous studies have evaluated the frequency and severity of Chronic Obstructive~     Pulmonary Disease (COPD) symptoms over a period of 24 hours (early morning, daytime and~     nigth-time symptoms) in stable COPD patients seen in clinical practice in Brazil. COPD is a~     common disease seen by primary care physicians and one of the most common diseases referred~     and diagnosed by pulmonologists. According to previous studies, symptoms of COPD can have a~     substantial impact on patients' quality of life and present a considerable degree of~     variation for the same degree of airflow limitation.~      The objective of this study is to learn more about the burden of symptoms in the real-world~     population of COPD patients in Brazil. With the real life data coming from this study, it~     will be possible to describe 24-hour COPD symptoms in Brazil and their impact on patients'~     quality of life and other PROs, the relationship with patients´ behaviour regarding adherence~     to respiratory medication and burden of COPD symptoms in terms of the impact on health~     economics.~      In the present study, the investigators will assess and characterize COPD symptoms over a~     period of 24 hours, by collecting information about the respiratory symptoms experienced at~     different times of the day and night in patients with stable COPD under real clinical~     practice conditions. In addition, the investigators will evaluate the correlation between~     each of these symptoms and the GOLD classification, adherence to respiratory treatment, level~     of dyspnea, disease severity, comorbidities and physical activity. Finally, the investigators~     will assess the relationship between 24h symptoms and direct cost related to treatment and~     HRU in the previous year to assess the burden of COPD symptoms.~      The present study is based on a similar protocol applied in Latin-American patients, the~     LASSYC Study. Extracted data will be used for a Brazilian analysis of these outcomes and may~     be used in future analyses combined with the results of LASSYC Study for a global view of~     Latin America.~   "
14160|NCT03381547|"~     To evaluate the pharmacokinetics of different dose levels and dose formulations of AM0010 in~     healthy adult patients~   "
14161|NCT03381534|"~     This is a prospective single-center,randomized controlled trial,aiming to investigate the~     safety and efficacy of distal EPD in vertebral artery origin stenting(VAOS);256 subjects will~     be recruited in this study,after randomized recruitment, treatment group(128 subjects each~     group) undergo VAOS with adjuvant distal embolic protection device（EPD）,control group undergo~     routine VAOS without distal embolic protection device.Intraprocedural and postprocedural~     in-hospital adverse events,including stroke,death and dis-retrieval of EPD,will be noted and~     cost-effectiveness analysis also will be conduct,including economic cost,hospital stays.~   "
14162|NCT03381521|"~     Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with~     involving compression of the median nerve in the carpal tunnel. Although many conservative~     managements of CTS, the effectiveness of these methods is insignificant or only persist for a~     short duration. The technique of nerve hydrodissection is now commonly used for peeling the~     nerve from surrounding soft tissue, which may help allow the impulse to pass, and rescue the~     nerve with ischemic damage. However, the exact effect and interval of hydrodissection are~     unknown because of the lack of well-designed studies Hence, investigators design a~     randomized, double- blind, controlled trail to assess the therapeutic effect of~     ultrasound-guided nerve hydrodissection in patients with CTS.~   "
14163|NCT03381508|"~     The software embedded in recent continuous positive pressure devices enables the analysis of~     the level of leakage that occurs during treatment around the mask or from the mouth. However,~     there is no clear threshold defining when it would be appropriate to implement means for~     correcting these leaks. In addition, the calculation methods used to detect/measure leaks and~     the terminology used vary according to the manufacturers of continuous pressure devices,~     which also complicates the clinical interpretation of the leakage reports provided by the~     various devices.~      In daily practice, when a patient complains of unintentional leakage, technicians adjust the~     mask, replace the nasal-mask by an oro-nasal mask or install a chinstrap. Nevertheless, those~     strategies are not always effective in reducing leakage or patient's complaints. A better~     understanding of the mechanisms beyond leak appearance for a given patient could lead to~     individualised leak-treatment solutions. Pressure level, mandibular behaviour, respiratory~     effort, sleep position or sleep stages may contribute to leak emergence.~      A recent exploratory study has proposed a genuine analysis method of determining factors of~     unintentional-leaks using polysomnographic recordings in OSA patients treated with automatic~     Continuous Positive Airway Pressure (auto-CPAP). Based on the same methodology, the NOMICS~     company (Liège, Belgium) has developed a polygraphic device (Brizzy®) recording unintentional~     leakage during auto-CPAP treatment and providing an etiological analysis of~     unintentional-leaks via a software named APIOS.~      Due to the innovative nature of the analysis, it appears necessary to validate it onto a~     population of OSA patients treated with auto-CPAP. Also, to our knowledge, there is no~     descriptive data of the distribution of the determinants of unintentional leaks in such a~     population. From this perspective, the investigators aim to retrospectively analyse some~     polygraphic recordings that have been performed with the Brizzy® on OSA patients treated with~     auto-CPAP.~      The primary objective of this study is to identify and describe the determinants of~     unintentional leaks for a population of patients with OSA and treated with an auto-CPAP~     device~   "
14164|NCT03381495|"~     Labor analgesia can alleviate intrapartum pain, in the importance of the delivery is very~     obvious.But some researches think labor analgesia may affect the progress of labor, increase~     the cesarean section rate.This research adopts the epidural anesthesia to study labor~     analgesia effects on labor and pregnancy outcomes.~   "
14165|NCT03381482|"~     In Alzheimer's disease (AD), neurofibrillary degeneration (NFD) is characterized by the~     intraneuronal aggregation of Tau proteins. The pathology progresses through a hierarchical~     pathway that may be associated with the intercellular transmission of pathology as~     demonstrated in our rat models. This transmission implies that Tau is actively secreted and~     may participate to the first steps of Tau pathology spreading. It is demonstrated in cell~     lines and animal models (rodents and non-human primates) that Tau is secreted not only in~     free forms but also in extracellular vesicles. If Tau is found in biological fluids before~     neuronal death it may represent an early marker of the NFD and will also define~     therapeutically targets. In this context, the aim is now to transfer this knowledge in humans~     and to decipher the nature of Tau secreted in plasma and cerebrospinal fluids collected from~     healthy controls to AD patients, and to decipher if the presence of tau inside vesicles is~     influenced by the pathology.~   "
14194|NCT03381105|"~     This part of the project aims to analyze the effectiveness of the Stockholm3 test in regular~     clinical practice, both in general practice and in the specialist health care, as a tool for~     detecting patients who need further diagnostics for prostate cancer.~   "
14195|NCT03381092|"~     This is a prospective, single-center, non-randomized, non-controlled observational study.~   "
14167|NCT03381456|"~     Cortical excitability depends on inhibitory mechanisms efficiency among which long latency~     intracortical inhibition (LICI) can be studied by paired pulses transcranial magnetic~     stimulation (TMS). Some recent evidences suggest that LICI may be one of the mechanisms by~     which the motor comment is adapted to the ongoing motor task with LICI strength being~     dependent on task complexity. In writer cramp and musician cramp, two forms of dystonia, the~     cortical excitability is not correctly modulated in some complex gestures. the hypothesis is~     that this task dependent perturbation of excitability in writer cramp could be due to a lack~     of LICI efficiency.~   "
14168|NCT03381443|"~     Participants of Immediate Life Support and Advanced Life Support Courses, where two different~     summative assessment methods were used are asked about their satisfaction with the assessment~     method using a questionnaire. Both quantitative questions using an 11-point-Likert scale as~     well as open-ended qualitative questions will be asked. The primary aim of this study is to~     find out which variant of summative assessment is perceived by course participants as testing~     their leadership competency best, immediately after the comparison as well as 1 year later to~     identify any long-term effects on the students.~   "
14169|NCT03381430|"~     To explore the survival benefit of the gefitinib combined with radiotherapy as adjuvant~     therapy for completely resected patients with Pathological stage IIIA-N2 NSCLC harbouring~     sensitive mutations of EGFR.~   "
14170|NCT03381417|"~     Accelerated AC regimen-Doxorubicin 60 mg/m2,Cyclophosphamide 600 mg/m2 on day 1 & day 14 of~     each cycle along with G-CSF support for up to 4 cycles, followed by Paclitaxel 175 mg/m2 in~     the next 4 cycles is the standard clinical practice in Vietnam for breast cancer, this~     regimen is to facilitate the dose-dense schedule, patients receive every-2-week therapy along~     with G-CSF support. the accelerated dose-dense schedule improve disease-free and overall~     survival among women with breast cancer .Primary objective of this study is to compare the~     efficacy and safety of Nanogen's Pegcyte and Roche's Neulastim for prevention of chemotherapy~     (Accelerated AC regimen)-induced neutropenia on breast cancer patients. Breast cancer~     patients scheduled to receive myelosuppressive chemotherapy (AC regimen) will be recruited in~     this trial. All eligible patients receive single subcutaneous injection of study drugs 24~     hours after chemotherapy administration in each cycle for 3 consecutive cycles. Efficacy and~     safety assessments will be assessed based on the incidence of severe neutropenia in~     combination of temperature > 38.3℃ or sepsis or life threatening infection and incidence of~     serious adverse events.~   "
14171|NCT03381404|"~     This is a single-centre, open-label, mass balance study in healthy male subjects utilising a~     single oral dose of [14C] MT 8554.~   "
14172|NCT03381391|"~     Emerging adulthood is a period of heightened vulnerability for problematic alcohol use.~     Considerable research has been devoted to reducing alcohol risks in college student~     populations, though far less effort has focused on their noncollege-attending peers. Research~     targeting nonstudent emerging adults is critical as this group is at risk for experiencing~     alcohol-related harms. Consequently, the main objective of the present study was to examine~     the preliminary efficacy of a brief personalized feedback intervention (PFI) tailored for~     nonstudent at-risk drinkers.~   "
14173|NCT03381378|"~     This study will encompass an analysis of an eventual association between vitamin D status~     (maternal during pregnancy, at birth or at 5 years) and hand grip strength at 5 years in~     children from Odense Child Cohort. Odense Child Cohort is a large-scale, prospective,~     population-based, follow-up study. Mothers and their children born from January 2010 to~     December 2012 and resident in the Municipality of Odense, Denmark, are followed from early~     pregnancy up to adulthood. Data is obtained from questionnaires and medical records and~     venous blood samples were drawn and stored at a biological bank.~      Low muscle strength in children has been linked to adiposity, cardiovascular disease and~     metabolic risk factors and low muscle strength in adolescence has been shown to be a risk~     factor of early adulthood mortality. There are not many studies on muscle strength in small~     children. There is some evidence of vitamin D concentrations in the blood having a positive~     correlation to upper body muscle strength in adolescent girls.~      Hypovitaminosis D defined as serum 25-hydroxyvitamin D <50nmol/L was evident in 27,8% of the~     pregnant women and 47,7% of the new-born children in Odense Child Cohort.~      Animal studies have shown an effect of vitamin D on regulation of muscle function and~     development. Studies on humans adults have shown that vitamin D deficiency can lead to~     myopathy. Myopathy in children as a result of hypovitaminosis D is not well-studied.~      Given the high prevalence of hypovitaminosis D, mild or severe vitamin D-associated myopathy~     may be prevalent in preschool children.~      The objectives of this study are 1) to create reference values and determine predictors of~     hand grip strength at five years, 2) to analyze the associations between vitamin D at~     different time points and hand grip strength at 5 years.~   "
14174|NCT03381365|"~     We aim to assess the efficacy of the Curaseal anal plug in patients with idiopathic~     uncomplicated fistulous tracts. Healing of the fistula tract will be assessed both clinically~     and radiologically with MR imaging.~   "
14175|NCT03381352|"~     The purpose of this study is to evaluate the efficacy and adverse events of intensity~     modulated radiation therapy (IMRT) concurrent with chemotherapy for anal squamous carcinoma.~     All enrolled anal squamous carcinoma patients are intented to receive IMRT concurrent with~     Capecitabine + mitomycin ± cetuximab targeted therapy.~   "
14176|NCT03381339|"~     In this three month, interventional clinical trial for the treatment of gingivitis we will~     assess the use of an oscillating-rotating powered toothbrush in comparison to the use of a~     manual toothbrush over 12 weeks in the absence of interproximal hygiene.~   "
14177|NCT03381326|"~     Identification of biomarkers (Circulating Tumor Cells (CTC), free DNA, Stem Cells and~     EMT-related antigens) that may be predictive of outcome of activity of cabazitaxel treatment~     in castration-resistant prostate cancer.~   "
14178|NCT03381313|"~     This study aimed at investigating the suitability of a classical conditioning for the~     treatment of anomic disorder. In this study 12 patients suffering from pure anomia in the~     chronic stage of the disease underwent a word repetition training with a computerized~     telemedicine protocol. Each patient trained two word sets, one in a conditioned and the other~     in a non-conditioned training modality; a third non trained set served as control set.~   "
20286|NCT03301441|"~     Sensitivity to Acute Middle cerebral or intracranial Carotid artery Occlusion in MIGrainers~     (SMCO-MIG) is a prospective multi-center study to determine if migraine induces a faster~     infarct growth as assessed by initial multimodal imaging.~   "
14179|NCT03381300|"~     Rationale: Infertility due is a major concern for girls with Turner syndrome (TS) and their~     parents. Physicians are often asked about possible options to preserve their fertility.~     However, despite some experimental case reports, clear evidence for fertility preservation in~     these girls is lacking and many questions remain. Without evidence on the effectiveness of~     fertility preservation it cannot routinely be offered to girls with TS.~      Objective: To investigate the occurrence of live birth in women with TS after ovarian tissue~     cryopreservation in childhood followed by auto transplantation in adulthood.~      Study design: A national multicentre exploratory intervention study~      Study population: Girls diagnosed with Turner Syndrome, aged 2-18 years.~      Intervention: Ovarian tissue cryopreservation in childhood followed by auto transplantation~     in adulthood. In order to obtain the ovarian tissue for cryopreservation, all girls must~     undergo a laparoscopy under general anaesthesia which will be performed in~     academic/university clinics with paediatric surgery. During the laparoscopic intervention, a~     unilateral oophorectomy will be performed, thereby leaving the other ovary intact for hormone~     production, ovulation, spontaneous pregnancies and as an auto transplantation site for~     cryopreserved-thawed ovarian cortical tissue later on. Furthermore, a small sample of the~     ovarian cortex will be used to assess the oocyte quality and genetics (e.g. the presence of~     germ line mosaicism). Oocytes will be karyotyped by using Fluorescence in situ hybridization~     (FISH). Karyotypic and hormonal data will be collected once at the yearly clinical visit at~     the paediatric-endocrinologist. Therefore, a buccal swab and one extra blood sample will be~     taken and evaluated during the routine laboratory evaluation.~      In the future, auto transplantation of frozen-thawed ovarian cortex strips will be performed.~   "
14180|NCT03381287|"~     This is a randomized, double-blind, placebo-controlled, multicenter, multiple ascending dose~     (MAD) study to evaluate the safety and tolerability, PK, and PD profiles of HTD1801 in~     overweight to obese adults with hypercholesterolemia. There will be 3 cohorts of dose levels~     as 500, 1000 and 2000mg/day, 16 subjects for each cohort with 12 subjects will administer~     HTD1801 and 4 subjects will administer Placebo.~   "
14181|NCT03381274|"~     The objective of this study is to investigate the safety, tolerability and antitumor activity~     of novel combination therapies administered in subjects with advanced EGFRm NSCLC~   "
14182|NCT03381261|"~     To compare Botox-treated and Botox-untreated symptomatic tissues (defined as areas where the~     head hurts and the pain is felt) of chronic migraine (CM) patients using molecular studies.~   "
14183|NCT03381248|"~     This is a prospective, randomized, multicenter comparison study examining the outcomes of~     subjects with osteoarthritis and knee pain undergoing a procedure to create a radiofrequency~     lesion of the genicular nerves with the Cooled Radiofrequency Ablation (CRFA) system compared~     to subjects receiving Hyaluronic Acid (HA). Approximately 168 subjects will be enrolled into~     this study, with subjects undergoing either CRFA or HA injection in a 1:1 randomization~     scheme. Follow-up will be conducted for 12 months post-CRFA, with the primary endpoint being~     completed at month 6. Subjects randomized to the comparison (HA) group will have the option~     to cross-over to the neurotomy group after completing the 6-month endpoint assessment. They~     will be followed for an additional 6 months. Pain, overall outcome, quality of life, pain~     medication use, and adverse events will be compared between the two treatment groups to~     determine success.~   "
14184|NCT03381235|"~     The purpose of this study is to look in humans at the relationship between moderate or little~     exercise and their potential effects on the retina in patients with Retinitis Pigmentosa~     (RP).~   "
14185|NCT03381222|"~     Background Incidence of perioperative stroke In cardiac surgery is 2.6-5.2%. Ascending aortic~     atheromatous plaque and stroke are strongly associated.~      Propose of study To determine incidence of ascending aortic atheroma in Thai people To~     identify risk factors which associated with ascending aortic atheroma~      Methodology After received standard general anesthesia and start sternotomy. Epiaortic scan~     will be performed by surgeon use L15-7i Phillips® ultrasound probe cover with sterile cover.~      Five standard epiaortic views will be collected. Epiaortic clips will be review and determine~     about atheroma by two qualified echocardiographers. Atheroma more than third grade will~     defined to significant. Potential risk factors of atheroma will be gather from medical record~      To assess the relationship between risk factors and atheroma a univariate analysis was~     performed using an unpaired t-test and a Chi-square test.~      For higher accuracy regarding the impact of single risk factors, a multiple logistic~     regression analysis was also performed.~   "
14186|NCT03381209|"~     The aim of this study is compare the reversal of rocuronium induced neuromuscular blockade in~     morbidly obese patients using three doses of sugammadex; based on ideal body weight, adjusted~     body weight, and actual body weight.~   "
14187|NCT03381196|"~     The purpose of this study is to evaluate the clinical and virologic benefit of pimodivir in~     combination with Standard-of-Care (SOC) treatment compared to placebo in combination with SOC~     treatment.~   "
14188|NCT03381183|"~     The purpose of this study is to see if the IRX-2 regimen, durvalumab, and tremelimumab will~     have a tolerable safety profile and will increase the intratumoral immune profile compared~     with the pretreatment tumors.~   "
14189|NCT03381170|"~     This study evaluates the long term use of a single agent ublituximab, a novel monoclonal~     antibody, in patients with relapsing forms of multiple sclerosis~   "
14190|NCT03381157|"~     Very low birth weight infants who are at risk for chronic lung diseases may also be at risk~     for brain anomalies such as increased echogenicity, leukomalacia and intracranial hemorrhage.~     Infants with bronchopulmonary dysplasia have been reported to have worse neurodevelopmental~     outcomes than healthy infants. It has also been pointed out that babies with prolonged and~     recurrent apneas during sleep may have weak General Movements (GMs) repertoire.~      It has been mentioned that motor development retardation may also occur in neurodevelopmental~     diseases, genetic diseases and chronic lung diseases, as well as in cystic fibrosis. In~     infants with cystic fibrosis, motor development may be affected by increased incidence of~     hospitalization, previous infections, malnutrition, respiratory and digestive system~     disorders. There is no research done with GMs assessment to determine motor dysfunction in~     infants with cystic fibrosis and this topic is open to research.~      Having more information about the motor development of babies by determining the motor~     characteristics and motor performance of infants with cystic fibrosis, it may be possible to~     start the disease-specific physiotherapy and rehabilitation programs as early as possible.~     For this reasons, in the study the investigators aimed to investigate the characteristics of~     GMs in the Fidgety period of 3-5 month term infants diagnosed with cystic fibrosis, to~     determine the motor performances and to investigate the relation between the GMs~     characteristics and the features of the disease.~      The hypotheses the investigators have set for this study are listed below;~      Ho: Spontaneous movements of the Fidgety period of infants diagnosed with 3-5 months of~     cystic fibrosis are not different from normal infants.~      H1: Spontaneous movements of Fidgety period of infants diagnosed with cystic fibrosis~     between 3-5 months are different from normal infants.~   "
14191|NCT03381144|"~     This is a randomized, double-blind, placebo-controlled, single-center, three-part study~     designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effects~     of single and multiple ascending doses of GDC-0334 and the effect of food on the~     pharmacokinetics of GDC-0334 in healthy adult participants.~   "
14192|NCT03381131|"~     Up to now, there is no Chinese version of fibromyalgia diagnosis criteria and severity~     assessment scales. The aim of this study is to translate, adapt, and validate the Chinese~     version of the 2011 modification of the 2010 ACR preliminary criteria for the diagnosis of~     fibromyalgia (2011ModCr) and 2016 ACR revisions to the 2010/2011 fibromyalgia diagnostic~     criteria, as well as the Fibromyalgia Impact Questionnaire (FIQ-C).~   "
14196|NCT03381079|"~     This study will evaluate the efficacy and safety of posterior scleral reinforcement on~     controlling myopia progression, including change in refraction, axial elongation as well as~     sight-threatening complications, in adults with high myopia. Half the adults will receive~     posterior scleral reinforcement, while the other half will receive no surgerical treatment.~   "
14197|NCT03381066|"~     This study aims to compare the efficacy of intercalating chemotherapy (gefitinib and~     pemetrexed/cisplatin) and chemotherapy (navelbine/cisplatin) in completely resected NSCLC~     with common EGFR mutations.~   "
14198|NCT03381053|"~     Evaluate the reliability of morphology standards for GIST pathologic type, staging and~     grading by retrospective analyzing clinical data; on this basis, establish a GIST~     standardized and individualized treatment mode to maximum benefit GIST patients, avoid under-~     and over-treatment~   "
14199|NCT03381040|"~     This study seeks to determine whether patients pursuing injectable treatments for facial~     volume loss and/or contour deficiency can be separated into strata based on characteristics~     such as skin envelope and subcutaneous tissue quantity in the zygomatic, submalar and~     anteromedial cheek regions in order to guide the clinician in making the ideal product choice~     (i.e., Restylane Volyme vs Lyft)?~   "
14200|NCT03381027|"~     It is well known that sleep is essential for brain development and learning. Infants require~     extensive sleep for development of the hippocampus, pons, brainstem, and midbrain and for~     optimizing physical growth. It is also essential for brain plasticity; the genetically~     determined ability of the infant brain to change its structure and function in response to~     the environment. Studies in young animals have shown that sleep deprivation leads to~     increased programmed cell death, smaller brain size, and loss of brain plasticity, all of~     which have negative long-term impact on behaviour and learning ability.~      Infant massage, a form of systematic tactile stimulation by human hands, improves sleep~     hygiene. Very little is known about how massage influences early brain development but it is~     certainly linked to the theory of environmental enrichment, which has been well established~     in animal models.~      The aim of this project is to optimise the infant's sensory experience through a~     multi-sensory enrichment programme, including massage (a massage utilising a scented lotion~     before sleep each day), to encourage more structured sleep and ultimately show improved~     developmental and cognitive outcomes.~   "
14201|NCT03381014|"~     Early detection of cardiomyopathy in patients receiving Anthracycline chemotherapy and~     determine if speckle tracking echo and Troponin gene will add benefit for early detection of~     cardiomyopathy.~      Improve economic impact of oncologic patients from whom high sensitive troponin negative and~     normal speckle tracking patients can be safely excluded from long-term cardiac monitoring~     programs.~      To correlate between the molecular gene expression of troponin genes and ryanodine receptor~     in cardiomyopathy~   "
14202|NCT03381001|"~     The transfer of frozen / thawed embryos has been routinely performed in the last 30 years as~     part of Assisted Reproduction treatment (ART). Currently, more than 50% of couples submitted~     to ART have surplus embryos eligible for freezing followed by transfer in subsequent cycles.~     Therefore the selection criteria for the thawed embryos to be transferred must be rigorous in~     order to maximize pregnancy and of live birth rates. Usually, the evaluation of the embryos~     before transfer can be performed based on blastomeres survival after a short culture period~     between thaw and embryos transfer, i.e., 2 to 5 hours, or based on embryo development over a~     prolonged period of culture (18h to 24h). Post-thaw embryo culture might have an impact on~     the recovery of mitosis and normal cellular functions. However, until now, there is no~     consensus in the literature on which post-thaw culture interval has a better impact on~     pregnancy and live birth rates. Also, blastocysts formation after freezing/thawing of embryos~     at cleavage stage may bring relevant information about post-thaw culture. Moreover, this~     strategy can be used as an alternative treatment. Therefore, the authors proposed this~     prospective randomized, triple-blind study to evaluate the impact of post-thaw embryo culture~     on the pregnancy and live birth rates.~   "
14203|NCT03380988|"~     The intervention was preceded by a 1-week run-in period during which participants underwent~     continuous glucose monitoring (CGM) and filled in a 7-day dietary record to optimize basal~     infusion rate and insulin-to-glycemic load ratio. The study had a randomized crossover design~     with each subject studied on 2 occasions at least 1 week apart. Participants were assigned to~     consume, in random order, two test meals with the same amount of carbohydrates (50g): a meal~     containing fiber-enriched buckwheat pasta (FBP) or corn pasta (CP), used as control. Over the~     experimental period, participants underwent CGM, wearing their sensors 7 days/week.~   "
14204|NCT03380975|"~     To determine the effect of Montelukast in Asthma and Allergic rhinits patients~   "
14205|NCT03380962|"~     Patients who have had a previous allograft failure represent a major problem for transplant~     centers as they are highly-human leukocyte antigen (HLA) sensitized and unlikely to receive~     another transplant without significant desensitization. This single center, phase I/II, open~     label single-arm exploratory study focuses on enrolling ten patients (ages 15-75) who will~     begin desensitization therapy to achieve HLA incompatible (HLAi) renal transplantation.~     Patients who qualify will receive up to 6 doses of clazakizumab 25 mg monthly~     pre-transplantation. If patients receive an HLAi transplant during the study, the~     participants will continue to receive another 6 monthly doses of clazakizumab 25 mg, followed~     by a 6 month protocol biopsy. Patients will continue another 6 doses over 6 months if~     improvements are seen after the 6th dose of clazakizumab. Patients who develop evidence of~     persistent allograft dysfunction may have non-protocol biopsies for cause. Patients who~     receive 12 doses of clazakizumab post-transplant will receive a 12M protocol biopsy.~   "
14206|NCT03380949|"~     This prospective randomized clinical trial evaluates the effects of a monitor-guided opioid~     analgesia during general anesthesia. To date no standard-monitoring device exists to~     specifically reflect the analgesic component of general anesthesia. Quality and safety of~     general anesthesia are of major clinical importance and should be improved by limiting the~     opioid analgesic's dosage to the minimum amount needed. The study compares the effects of~     monitoring nociception during general anesthesia with different innovative techniques in~     comparison to routine clinical practice.~   "
16699|NCT03348358|"~     The purpose of this study is to randomize women to be exposed during labor to different~     genres of music and study the effect of each genre on the level of objective and subjective~     stress as manifested by salivary cortisol and personal stress questionnaires, respectively.~     Secondary outcomes to be examined are obstetric and perinatal outcomes~   "
14207|NCT03380936|"~     This is a pilot study to determine if extended release Envarsus at an optimal level is just~     as effective as more invasive standard therapies for subclinical (mild) AMR (antibody~     mediated rejection) in kidney transplant patients. Subjects will be randomized to either~     conversion to Envarsus XR (extended release); or, to a standard of care regimen of plasma~     exchange/IVIG (intravenous immunoglobulin)/rituximab treatments.~   "
14208|NCT03380923|"~     The PHITE collaborative team, consisting of Tim Broderick, MD (Overall PI), Wright State~     University (WSU); Marcas Bamman, PhD (Site PI), The University of Alabama at Birmingham~     (UAB); and Ron Evans, PhD and Joe Ecker, PhD, Salk Institute for Biological Studies, are~     working with funding from the US Department of Defense (DoD), Office of Naval Research (ONR),~     to explore the link between physical training and epigenetics. This is a key interest area~     for the DoD ONR because it provides high-impact optimization of force readiness in~     warfighters with diverse backgrounds.~      The term epigenetics refers to heritable changes in gene expression (active versus inactive~     genes) that does not involve changes to the underlying DNA sequence; a change in phenotype~     (the set of observable characteristics of an individual resulting from the interaction of its~     genotype with the environment) without a change in genotype (the genetic constitution of an~     individual organism) . This in turn affects how cells read the genes. Epigenetic change is a~     regular and natural occurrence but can also be influenced by several factors including age,~     the environment/lifestyle, and disease state. Epigenetic modifications can manifest as~     commonly as the manner in which cells terminally differentiate to end up as skin cells, liver~     cells, brain cells, etc. New and ongoing research is continuously uncovering the role of~     epigenetics in a variety of human conditions. This study is designed to assess whether~     epigenetics is a primary mechanism modulating how individuals adapt to specific exercise~     training prescriptions designed to produce a warfighter phenotype.~      The PHITE team is organized around a shared test population of human subjects for which UAB~     will oversee recruitment, training, testing, and sampling. Healthy but untrained volunteers,~     both men and women, 18-27 y of age—phenotypical of the US warfighter—will participate in a~     12-wk, two-arm, single-blind, randomized, exercise dose-response trial comparing two~     intensities of combined training: Moderate-Intensity vs. High-Intensity. Biospecimens are~     collected before and after an acute exercise bout in the pre-training state, and again after~     12 weeks of 3 d/wk combined exercise training. Numerous phenotyping assessments are collected~     before after the 12-week intervention period to associate exercise training outcomes with~     molecular changes in the skeletal muscle and blood biospecimens.~   "
14209|NCT03380910|"~     The purpose of this study is to test the effectiveness of an experimental process to aid~     Spanish-speaking patients in quitting smoking with the help of pharmacists and behavioral~     health psychologist trainees and clinicians.~   "
14210|NCT03380897|"~     Randomised trial comparing double balloon catheter for induction of labor between inpatient~     and outpatient groups. The investigators assess how sleep disturbances and depression of the~     mother affect to the pain during balloon catheter induction of labour.~   "
14211|NCT03380884|"~     The occurrence of distal radius fractures is well known to be a sentinel event as these~     fractures are associated with 2 to 4 times increased risk of subsequent hip fractures in~     elderly patients. Studies have shown a significantly increased degree of postural sway in~     these patients, which is strongly associated with recurrent falls. The latest Cochrane~     systematic review also shows a lack of evidence on the effectiveness of current~     rehabilitation interventions.~      Low-magnitude high-frequency vibration (LMHFV) is a biophysical intervention that provides~     non-invasive, systemic mechanical stimulation and has been shown to improve muscle strength~     and balancing abilities in healthy, independent and active elderly women in our previous~     clinical study. Our animal studies have also shown LMHFV promoting myogenic proliferation and~     hypertrophy, muscle contractibility, and increased fast-fiber switching to muscle fiber type~     IIA.Previous rehabilitation studies have used clinical functional performance tests, which~     lack sensitivity and specificity in predicting impaired postural control. The Biodex Balance~     System SD consists of a dynamic balance platform interfaced with computer software, which~     offers objective and reliable tests for postural stability and fall risk.~      This study is a single-blinded, prospective randomized controlled trial to investigate the~     effect of 6 months of LMHFV after a distal radius fracture in elderly patients. Patients will~     be recruited and randomized to control or LMHFV group by envelope drawing of~     computer-generated random numbers. The intervention group will undergo LMHFV at 35Hz, 0.3g~     (peak to peak magnitude), displacement of <0.1mm, 20 min/day, at least 3 days/week for 6~     months in community centres. Control group will remain in their habitual life style and no~     vibration used. Outcome assessments will be performed at baseline 0 days, 6 weeks, 3 months~     and 6 months. Outcome assessor and statistician will be blinded to group allocation.~      The primary outcome is the effect of LMHFV on postural stability. The Biodex Balance System~     SD is used to measure the static and dynamic ability of the subjects to maintain the center~     of balance. Secondary outcomes are the occurrence of fall for the patients in both groups,~     the health-related quality of life (SF-36), and Timed Up and Go test for basic mobility~     skills.~   "
14212|NCT03380871|"~     The purpose of this study is to find out if treatment with NEO-PV-01 in combination with~     pembrolizumab and chemotherapy (pembrolizumab/chemotherapy) is safe and useful for patients~     with lung cancer. The study also will assess if the NEO-PV-01 vaccine, when given together~     with pembrolizumab and chemotherapy, can improve your response compared with pembrolizumab~     and chemotherapy treatment alone. All eligible patients will receive NEO-PV-01 + Adjuvant,~     pembrolizumab and chemotherapy while on this trial.~   "
14213|NCT03380858|"~     In colorectal surgery about 30% of postoperative mortality is attributed to anastomotic leak,~     whit an incidence range between 1.8% and 15.9%. Preventing the anastomotic leak can therefore~     bring benefits to the patient and the health system. To date we have technologically advanced~     suturizers and the correct realization (well-vascularized margins, not in tension, etc.)~     remains crucial to prevent anastomotic dehiscence. Experimental results demonstrate that~     modified cyanacrylate is a suitable potential reinforcement on intestinal anastomoses~     (manual or linear intra-corporeal). Applied after mechanical anastomosis, it polymerizes in a~     short time, closing the spaces of the suture line between one point and the other, expressing~     an adhesive, hemostatic and sealing action on the tissues, also creating an effective~     antiseptic barrier towards of the most common infectious or pathogenic agents.~   "
14214|NCT03380845|"~     The primary objective of this randomized, split-face, controlled study is to compare the~     efficacy and safety of a erbium-doped 1,550-nm non-ablative fractional laser and a bipolar~     fractional radiofrequency microneedle device for the treatment of atrophic facial acne scars~     in ethnic skin (Fitzpatrick Skin Phototypes III-VI).~      The hypothesis of this study is that both erbium-doped 1,550-nm non-ablative fractional laser~     and the bipolar fractional radiofrequency microneedle device are equally effective for the~     treatment of atrophic acne scars in ethnic skin (SPT III-VI). However, the bipolar fractional~     radiofrequency microneedle device has less adverse effects than erbium-doped 1,550-nm~     non-ablative fractional laser due to the absence of scattering and the absence of~     chromophore-specific targets - predominantly melanin - traditionally needed with laser~     treatments; hence the fractional radiofrequency microneedle device will have a higher safety~     profile in darker skin types .~   "
14215|NCT03380832|"~     Is the ability to perceive motion altered by diabetes? The investigators are measuring motion~     perception using a technique called vestibular thresholds. Subjects will undergo 3 hours of~     testing in which they sit in a chair that makes small movements and report their perception~     of motion. The investigators are currently looking for individuals who have had type 2~     diabetes for at least 10 years.~   "
14216|NCT03380819|"~     The VetSeq Study is a pilot intervention study exploring the feasibility of integrating~     genome sequencing into clinical care at the VA Boston Healthcare System.~   "
14217|NCT03380806|"~     A randomized controlled open-label trial in patients with high risk prostate cancer. Eligible~     and consenting patients will be randomly allocated to receive stereotactic body radiotherapy~     (SBRT) boost to prostate or conventional radiotherapy boost to prostate in 1:1 ratio.~     Prostate radiotherapy boost will be administered after standard pelvic radiotherapy. Subjects~     will be followed for 24 months post radiation treatment for Quality of Life assessment and~     toxicity.~   "
14218|NCT03380793|"~     To assess the efficacy, safety, tissue distribution of target organ and Population~     Pharmacokinetic (PPK) of morinidazole and sodium chloride injection with surgery in patients~     with suppurative or gangrenous appendicitis~   "
14219|NCT03380780|"~     This single-center, open-label study will evaluate the pharmacokinetics, safety, and~     tolerability of emicizumab following a single subcutaneous (SC) administration to healthy~     Chinese subjects.~   "
14220|NCT03380767|"~     Trauma is the leading cause of death in young people. Trauma-induced coagulopathy (TIC)~     encompasses several aspects of traumatic bleeding. Monitoring of coagulopathy comprises use~     of Point-of-Care (POC) methods, such as thromboelastography (TEG) or Thromboelastometry~     (ROTEM) and conventional laboratory assays (platelet count, fibrinogen level, and PT or INR).~      POC tests are thought to have a better performance on mortality and bleeding control than~     conventional tests. The aim of this study is to compare POC and conventional assays with~     plasma consumption as a primary outcome and 28 days mortality as a secondary one.~   "
14221|NCT03380754|"~     The aim of this study is to investigate the effect of preoperative carbohydrate rich drinks~     on postoperative nausea and vomiting in total knee arthroplasty. This is a prospective,~     double blinded, randomized controlled trial.~   "
14222|NCT03380741|"~     This study aims to establish whether tumour markers measured from cytological samples can~     improve cervical cancer detection both prior to treatment and after treatment during follow~     up.~      All patients with presumed early cervical cancer referred to the Gynaecological Oncology Unit~     at The Royal Marsden Hospital and patients previously surgically treated for early cervical~     cancer with a suspected recurrence will be invited to participate.~      Women attending the Colposcopy Unit at St George's Hospital, with a normal cervix will be~     invited to participate.~      An endovaginal receiver coil has been designed and developed at the Institute of Cancer~     Research and Royal Marsden NHS Foundation Trust for use at high field strengths (3T).~      A cytology swab, similar to a smear test, will be used to collect a sample of cells to~     evaluate the presence of tumour markers.~      The presence of tumour markers will be measured by a lab-on-a-chip and polymerase chain~     reaction (PCR) testing system.~   "
14223|NCT03380728|"~     Approximately 5% of the world's adult population has some alcohol-related disorder, which in~     addition is associated with 3% of all deaths in the world. In Brazil, harmful use and~     dependence on alcohol reach about 10% of the population, with alcohol being one of the main~     factors of disease and mortality. Although the medications currently used have some efficacy,~     the adverse effects and relatively long time of treatment are factors that may reduce~     patients' motivation to continue taking the medication correctly. Therefore, it is necessary~     to conduct research with new drugs for the treatment of alcoholism. Ibogaine is an alkaloid~     present in the bush Tabernanthe iboga (iboga), a plant from Central Africa traditionally used~     in countries such as Gabon and Cameroon. Animal studies and case series suggest that one or a~     few doses of ibogaine significantly reduce withdrawal symptoms and the intensity of use of~     various drugs, including opioids, psychostimulants, and alcohol. However, there are no~     controlled clinical studies that have explored these effects. The aim of the present study is~     to evaluate the safety, tolerability and efficacy of increasing doses of ibogaine in 12~     alcoholic patients. Each patient will be hospitalized for 20 days and receive 3 increasing~     doses of ibogaine. The first 3 patients will receive oral doses of 20 to 400 mg of ibogaine~     in an open-label design. If the 3 higher doses (240, 320 and 400 mg) are well tolerated, the~     next 9 volunteers will receive these doses or placebo randomly. The volunteers will also be~     evaluated 7, 14 and 21 days and 1, 3, 6 and 12 months after leaving the hospital to monitor~     the consumption of alcohol and other drugs.~   "
14224|NCT03380715|"~     Co-phenylcaine is a widely available nasal spray commonly used by otorhinolaryngologists for~     the purpose of decongestion and local anesthetic prior to a nasoendoscopic or~     nasopharyngolaryngoscopy. It is often used in the outpatient setting and is also useful for~     minor procedures. It is unique in its properties because it provides both local anesthetic~     and decongestive effects on the nasal mucosa hence leading to better visualization of the~     nasal cavity and better comfort for the patient during the procedure.~      Pharmacologically, Co-phenylcaine Forte comprises of a combination of Lignocaine 5% (50mg/ml)~     and phenylephrine 0.5% (5mg/ml) and is commonly marketed in a 50ml bottle attached to a~     disposable positive displacement atomizer which avoids contamination by preventing~     contamination of the nozzle tip by secretions from other patients which are commonly seen in~     older venturi devices.Its decongestive agent (phenylephrine) acts by influencing the~     sympathetic vasculature tone via alpha adrenoceptors since its properties are sympathomimetic~     and oppose vasodilation.As for the local anesthethic component (Lignocaine) , it is an amide~     local anesthetic which blocks fast voltage gated sodium channels in the cell membrane thus~     leading to a decrease in sensation when performing a nasoendoscopy. Despite of its~     advantages, there are also disadvantages in the usage of such a device such as the need for~     regular change of the nozzle head due to the risk of infection and the high cost of using~     this device in the long run.~      Several studies has demonstrated promising results for the efficacy of nebulized medication~     and its distribution of medication into the nasal cavity and paranasal sinuses in both~     healthy individuals and cadaver models.Its advantages over the classical nasal spray include~     better distribution of medication throughout the nasal cavity and better hygiene due to the~     ability to change and sterilize the nasal nozzle tip before re-usage.~      Very little information is available about the delivery of topical decongestants via nasal~     nebulization on the pre-endoscopic examination of the nasal cavity. This study aims to~     compare the efficacy of topical decongestants delivered into the nasal cavity using nasal~     nebulization against the delivery of topical decongestants using conventional nasal sprays.~   "
14245|NCT03380442|"~     The main aim of the study is to investigate the possible long-term therapeutic effects of~     psilocybin on the symptoms of severe depression, as well as the brain mechanisms underlying~     these changes. Depression severity is assessed before and after (i.e., 1 week, 3 months and 6~     months after) a single dose of psilocybin and compared to respective scores of a group~     receiving an active placebo, ketamine. Brain activity (using functional magnetic resonance~     imaging) is measured before and one week after drug administration in order to determine~     whether changes in brain networks related to emotional and self-referential processing~     correlate with any observed changes in depression scores. Further, blood samples will be~     obtained from the participants and analyzed in order to reveal gene expression and molecular~     level correlates underlying rapid antidepressant effects, and to identify biomarkers that~     predict treatment outcome.~   "
16756|NCT03347617|"~     This pilot phase II trial studies how well ferumoxytol magnetic resonance imaging (MRI) works~     in assessing response to pembrolizumab in patients with brain tumors from melanoma and~     glioblastoma. Diagnostic procedures, such as ferumoxytol MRI, may help measure a patient's~     response to pembrolizumab treatment.~   "
14225|NCT03380702|"~     Lighter tooth color may improve patient satisfaction with facial aesthetics. Few data exist~     regarding the impact and association of of tooth color connection with quality of life.The~     purpose of this research is to explore the extent to which patients perceive a color change~     and difference in quality of life induced by tooth whitening after one week and after one~     year.~      A plan is to assess 100 participants for eligibility (aged 18-30 years) and to enroll at~     least 70 and randomly assign to an active or a control group (equal number of participans in~     each group). Their anterior teeth in both jaws will be bleached with a photo-activated~     whitening gel, or will be subjected to a placebo. Lightness, chroma and translucency of teeth~     will be assessed before (T0), one week (T1) and one year (T2) after the procedure by a~     spectrophotometer. The subjects in both occasions will administrate the psychometric~     instrumetns Psychosocial Impact of Dental Aesthetics Questionnaire, Orofacial Esthetic Scale,~     Oral Health Impact Profile and Smile Esthetics Related Quality of Life. Influence of~     personality traits on the perception of changes in smile aesthetics and qualiy of life will~     be also explored (extraversion, conscientiousness, neuroticism, agreeableness, openness to~     experience, perfectionism, self-esteem, body image).~   "
14226|NCT03380689|"~     Phase I Study of biweekly combination therapy with S-1, Irinotecan, and Bevacizumab as 1-line~     Chemotherapy in Patients With Advanced Colorectal Cancer.~   "
14227|NCT03380676|"~     To better define the clinical characteristics of oromandibular dystonia, we aimed to study~     voice, speech and swallowing disorders in idiopathic oromandibular We planned to include~     consecutive patients followed in Lille Movement disorders department for idiopathic~     oromandibular dystonia and matched, healthy control subjects. Voice and speech disorders had~     to be assessed with the phonetic analysis, perceptive analysis and motor examination modules~     of the Batterie d'Evaluation Clinique de la Dysarthrie (Clinical Evaluation of Dysarthria),~     the Grade, Rough, Breathy, Asthenic, Strained scale, and a computer recording. Activities of~     daily living had to be assessed with the Oromandibular Dystonia Questionnaire, the Voice~     Handicap Index and the Deglutition Handicap Index.~   "
14228|NCT03380663|"~     The overall objective of this study is to uncover and utilize the mechanisms behind the~     activation of endogenous organ protection by remote ischemic conditioning (RIC), high~     intensity traditional resistance training (TRT) and low intensity blood flow restricted~     resistance exercise (BFRE) with the perspective of defining their applicability for immediate~     organ protection in ischemia-reperfusion injury (acute conditioning) and subsequent tissue~     repair (chronic conditioning) during a prolonged recovery period. This objective will be~     achieved by studying which and how molecular pathways underlying these protective mechanisms~     are shared and can be transferred to treat medical conditions. A specific focus is the roles~     of EVs and miRNAs. Another objective is to explore how exercise training with and without~     ischemia can counteract muscle wasting.~   "
14229|NCT03380650|"~     This study will evaluate the effectiveness and safety of directional atherectomy plus local~     drug delivery using balloon catheter system in the treatment of femoropopliteal occlusive~     disease. Patients of femoropopliteal occlusive disease will randomly receive directional~     atherectomy plus local drug delivery using balloon catheter system and dilation using~     drug-coated balloon. Their clinical outcomes (e.g. 12-month late lumen loss rate, 1-year~     patency rate of target vessel) in 1 year after the treatment will be compared.~   "
14230|NCT03380637|"~     This study evaluates the effectiveness of ultrasound in term pregnant patients posted for~     elective lower segment cesarean sections and compared them with non pregnant females posted~     for elective surgeries.~   "
14231|NCT03380624|"~     Crossover comparison of lipid layer thickness with two artificial tear formulations~   "
14232|NCT03380611|"~     The primary objective of this study is to investigate the effects of wakame and spirulina~     consumption on intestinal cholesterol absorption.~   "
14233|NCT03380598|"~     This study evaluates the families' and health care professional's experience from using a web~     based support system including mobile applications for self-monitoring weight and physical~     activity. Changes in BMI standard deviation score are compared between usual care (control)~     and usual care with complementary web-based support system (intervention).~   "
14234|NCT03380585|"~     In this clinical trial, the researchers will investigate the effect of single-file~     reciprocating file system (Reciproc) versus multi-file rotational file systems (ProTaper~     Next) on the postoperative pain in adult patients who have necrotic pulp and apical~     periodontitis. The participants will be assigned by chance to separate groups that compare 2~     different treatments, reciprocating single-file system (Reciproc) and rotational multi-file~     system (ProTaper Next).~   "
14235|NCT03380572|"~     The Senhance™ surgical robotic system, previously known as Telelap Alf-X (TransEnterix,~     Morrisville, NC, USA) has recently become available in the UK. It aims to provide the robotic~     benefits of greater accuracy, dexterity and control with similar operational costs to~     traditional laparoscopy.~      Patients randomly received either a standard laparoscopic cholecystectomy or the Senhance~     assisted cholecystectomy based on scheduled surgery date. A prospectively maintained database~     of the first 20 patients undergoing cholecystectomy with the Senhance Surgical System was~     retrospectively interrogated and compared to a concurrently treated group of 20~     laparoscopically treated patients during the same timeframe.~   "
14236|NCT03380559|"~     The study aims to demonstrate that intramuscular injection of botulinum toxin with a~     paralyzing dose coupled with subcutaneous injection of corticoid has greater efficacy than~     corticoid injection only or toxin injection only for treating lateral epicondylitis in~     reducing pain at 6 months.~      As secondary objectives, the study aims to~        -  demonstrate improvement of quality of patient's life and positive effect on their~          resuming to professional activities or sportive activities.~        -  evaluate tolerance of treatment by grip strength measurement and adverse event~          collection.~   "
14283|NCT03379948|"~     Catheter related infections (CRIs) were found to be associated with several risk factors,~     including patient related risk factors such as age, gender, clinical status and catheter~     related risk factors such as the vascular access location, dwelling time, catheter type and~     number of lumens. In addition to the inserted solution type and the experience of the~     professional who performs the procedure ,These factors constitute important strategic points~     for actions to compare the infectious complications of peripheral versus central venous~     catheters in critically ill patients.~   "
14237|NCT03380546|"~     Caring for women with gestational diabetes mellitus (GDM) is very time-consuming. Therapeutic~     strategy includes dietary and lifestyle measures and additional insulin therapy for 15 to 40%~     of the women with GDM if the glycemic targets are not achieved after a period of 1 to 2 weeks~     of diet. Insulin therapy is imperfect for the following main reasons: need for education~     (i.e. subcutaneous administration, dose titration), hypoglycemia and weight gain, limited~     acceptance and high cost. Psychosocial deprivation is associated with more cases of GDM and~     health accessibility may be unequal.~      Glucosidase inhibitors (acarbose) reduce intestinal absorption of starch and reduce the rate~     of complex carbohydrate digestion. It mainly lowers postprandial glucose values and is used~     in type 2 diabetes for a long time. Less than 2% of a dose is absorbed as active drug in~     adults, with 34% of the metabolites found in the systemic circulation. Doses of up to 9 and~     32 times the human dose were not teratogenic in pregnant rats or rabbits. Limited but~     reassuring data during pregnancy are available. Acarbose was well tolerated (little~     gestational weight gain, no hypoglycemia) with digestive discomfort in some women, balanced~     by treatment satisfaction as compared with insulin injections. Our hypothesis is that~     treatment aiming to control postprandial glucose values with acarbose as compared with~     prandial insulin injection will be as efficient and safe, but more convenient and less~     expensive.~   "
14238|NCT03380533|"~     Arthroscopic rotator cuff repair is associated with poor post-operative pain management. The~     multimodal analgesic scheme (oral non-steroidal anti-inflammatory drugs associated with oral~     opioids) currently used according to the pain management guidelines is insufficient for most~     of these patients.~      There are few reports on the use of buprenorphine in post-operative pain with encouraging~     results. There is no evidence of its use in the management of post-operative pain of~     arthroscopic rotator cuff repair~   "
14239|NCT03380520|"~     To assess impact on left ventricular reverse remodeling defined as a change in left~     ventricular ejection fraction in heart failure patients with reduced ejection fraction (and~     previous implantation of cardiac resynchronization therapy) undergoing treatment with ferric~     carboxymaltose vs. placebo~   "
14240|NCT03380507|"~     Despite recent medical advances, sepsis and septic shock remain a major cause of death.~     Sepsis is a syndrome with a wide array of physiologic, pathologic, and biochemical~     abnormalities.~      Several studies have shown vitamin C have decreased the circulating pro-inflammatory~     cytokines and oxidative stress.Thiamine had favorable effects on pro-inflammatory cytokines,~     oxidative stress and cellular hypoxia.The use of hydrocortisone in combination with vitamin C~     will increase the transport of vitamin C into the cells; since the pro inflammatory cytokines~     have shown to decrease the expression of the sodium-vitamin C transporter-2 (SVCT2) while~     glucocorticoids increase the SVCT2 expression.~      A recent small retrospective study , showed a significant decrease in mortality when patients~     with severe sepsis and septic shock are treated with a combination of Hydrocortisone, Vitamin~     C, and Thiamine. Conducting a similar study with a prospective randomized design will give~     clinicians all over the world more answers and will help clinicians to provide better care to~     millions of patients using highly safe therapeutic regimen.~      The objective of the current study is to explore the clinical benefits of using a combination~     of hydrocortisone, vitamin C, and thiamine (triple therapy) for the management of septic~     shock. To achieve this objective, we will compare two alternative treatment strategies,~     either triple therapy or usual care in patients with septic shock.~      First aim: To assess the effectiveness of the triple therapy for septic shock~      Second aim: To assess the safety of triple therapy~   "
14241|NCT03380494|"~     The purpose of the trial is investigate the benefits of a novel, newly invented exercise~     technique protocol relative to physiological changes in upper limb proprioception (primary)~     and subjective readiness for return to sport (secondary).~      The intervention (Overhead perturbation training) will be compared with a control~     intervention (non-perturbed stimulus) in a population of type II anterior glenohumeral joint~     instability patients (according to the Stanmore classification of instability). Each group~     will be assessed at baseline for glenohumeral joint proprioception (via lazer-pointer active~     relocation test), as well as perceived functional level (via Western Ontario Shoulder~     Instability index) and Shoulder Instability‑Return to Sport after Injury (SIRSI) score. They~     will then undertake a 6 week exercise regime which is exactly the same- except the~     intervention used perturbated stimulus and the control uses non-perturbed stimulus. Outcome~     measures are re-assessed at the end of the intervention period. Results will be assessed~     statistically for statistical significance.~   "
14242|NCT03380481|"~     Stroke is the first most common cause of death in China and one of the major causes of~     functional disability in the adult population.The burden of stoke is significantly increased~     in China in recent years.~      In order to investigate the prognosis of stroke, with diagnostic and treatment information of~     traditional Chinese medicine (TCM), and assess the effectiveness and safety of TCM for stroke~     in southern China, the investigators will conduct this multicenter prospective registry study~     in southern China. This study will recruit 10,000 consecutive eligible patients with acute~     stroke from more than 50 hospitals. 24 months follow-up will be carried out on-site in~     hospitals and by telephone to track endpoint (including all-cause mortality, composite~     cerebrovascular and cardiovascular events at one and two year follow up, and neurological and~     functional assessments).~   "
14243|NCT03380468|"~     Solid subtype, micropapillary subtype, vascular involvement, pleural involvement and low~     differentiation are high risk factors of post-operative recurrence for early-stage lung~     adenocarcinoma patients. The purpose of this clinical trial is to determine whether the~     widely used adjuvant chemotherapy strategy cisplatin/ pemetrexed is more effective than no~     further treatment for Stage pI lung adenocarcinoma patients with high post-operative~     recurrence risk - in terms of no dose related toxicities, premature treatment withdrawal or~     death.~   "
14244|NCT03380455|"~     A study in healthy male subjects to investigate whether repeated administrations of~     cimetidine (a medication which decreases the amount of acid in the stomach) can affect the~     fate in the body (amount and time of presence in the blood) of lucerastat. Safety of the~     concomitant administration of the two treatments will also be assessed.~   "
14318|NCT03379493|"~     This is a non-randomized, single arm, open-label, single institution, phase I study to~     determine the maximum tolerated dose (MTD) of ET190L1-ARTEMIS™ T cells in patients ≥ 18 years~     of age with relapsed or refractory CD19+ Non-Hodgkin's lymphoma.~   "
14246|NCT03380429|"~     GlaxoSmithKline (GSK) in collaboration with Propeller Health has developed a sensor, which~     can clip on to the ELLIPTA® dry powder inhaler (DPI) and monitor the time and date that the~     ELLIPTA DPI cover is fully opened and closed. Additionally, a sensor will be attached to the~     rescue medication metered dose inhaler (MDI). The data from both sensors will be fed back to~     the subject via an application (app) on smart phone and will be reviewed by the subject's~     health care professional (HCP) via an online dashboard. The sensors, app, dashboard and~     systems to provide data comprise the CIS. This study will be the first to evaluate the effect~     of CIS on adherence to maintenance therapy in subjects with uncontrolled asthma. This is an~     open-label, randomized, parallel group study in asthmatic subjects currently on a fixed dose~     inhaled corticosteroid (ICS)/long-acting beta 2 agonist (LABA) maintenance therapy. Eligible~     subjects will receive RELVAR®/BREO® maintenance therapy via ELLIPTA DPI and salbutamol rescue~     medication via MDI with sensors attached to both inhalers during the run-in period, which may~     last for up to 3 months. Eligible subjects will then be randomized into five treatment arms~     depending on whether the data, from RELVAR/BREO ELLIPTA or RELVAR/BREO ELLIPTA and salbutamol~     MDI, is fed back to the subject or subject and HCP, or not at all. The treatment period for~     the study is approximately 6 months and there will be a follow-up period one week post last~     visit. The total duration of a subject in the study will be approximately 9 months. RELVAR,~     BREO and ELLIPTA are registered trademarks of GlaxoSmithKline group of companies.~   "
14247|NCT03380416|"~     Patients with type 2 diabetes and non-alcoholic fatty liver disease will be enrolled.~      According to a parallel design, the participants will be randomized to a Portfolio diet or a~     monounsaturated fatty acid (MUFA)-rich diet (used as control) for 8 weeks.~      At the beginning and at the end of the trial, the participants will undergo a MRI~     spectroscopy to evaluate fatty liver content. Moreover, the participants will undergo a test~     meal resembling the nutritional composition of the assigned diet to evaluate fasting and~     postprandial metabolic response.~   "
14248|NCT03380403|"~     The feet of diabetic patients continue to be an important problem in medicine. In general,~     patients with diabetic foot have some sort of amputation, especially in underserved~     populations. It is clearly necessary to develop novel treatment strategies for this worldwide~     health problem. Photodynamic therapy (PDT) , is a low cost and highly effective alternative~     treatment concerning infections avoiding amputations in the diabetic foot.~   "
14249|NCT03380390|"~     This study will evaluate the safety and tolerability of oxymetazoline HCl cream 1.0% when~     used as an adjunctive treatment to energy-based therapy for participants with moderate to~     severe persistent facial erythema associated with rosacea.~   "
14250|NCT03380377|"~     Antibody mediated rejection (ABMR) is a unique, significant and often severe form of~     allograft rejection. This single center, phase I/II, open label single-arm exploratory study~     focuses on enrolling ten patients with biopsy proven chronic antibody medicated rejection~     and/or donor specific antibody present at time of biopsy. Patients who qualify will be~     receiving clazakizumab (anti-IL6 monoclonal antibody) monthly x six doses. A protocol biopsy~     will be performed at 6 months and if improvement is seen, patients will continue another six~     doses for up to 12 months. For those completing 12 doses, there will be a 12 month protocol~     biopsy. For those who only received six doses, the next and last study visit will be at 12~     months from enrollment. Total study duration is 12 months.~   "
14251|NCT03380364|"~     The aim of this work is to assess the value of hysteroscopy in unexplained infertility.~   "
14252|NCT03380351|"~     The goal of this study is to specify the interventions, implementation strategies and control~     conditions from the Sickle Cell Disease Implementation Consortium (SCDIC) using a~     mixed-methods approach to study site materials and conduct semi-structured qualitative~     interviews with site representatives (N=3 per site).~   "
14253|NCT03380338|"~     To investigate whether targeted lifestyle intervention (exercise), induces a change in~     intestinal fecal microbiota related to improved glycemic control and systemic inflammation in~     patients with DM type 2.~   "
14254|NCT03380325|"~     This study examines the effects of iloprost - a stable prostacyclin analogue - on~     insulin-mediated muscle capillary recruitment and whole-body glucose uptake in a cross-over~     design.~   "
14255|NCT03380312|"~     The aim of this study is to measure the mesh shrinkage and the visualization of the mesh with~     MRI scan at 1 month and 13 months after robot assisted retromuscular incisional hernia repair~     with ipsilateral access and the use of the visible CICAT mesh (Dynamesh®) for defect repair.~     The investigators also want to measure the volume of the rectus muscles and the change~     between 1 and 13 months.~   "
14256|NCT03380299|"~     The interactions of chronic lymphocytic leukemia cells with the microenvironment in secondary~     lymphoid tissues and the bone marrow are known to promote CLL cell survival and proliferation~   "
14257|NCT03380286|"~     The objective of this study is to evaluate effectiveness and safety of Firehawk® stent in the~     real world daily practice as compared with other drug-eluting stents.~   "
14258|NCT03380273|"~     This study is designed to collect data from 8,476 fracture patients during a pre-and~     post-intervention phases of two years length each. The intervention consists on the~     implementation of the AOT SSI Prevention Bundle.~      D~   "
14259|NCT03380260|"~     The primary goal of the present study is to test whether neural activity in brain regions~     associated with processing threat and social stimuli may underlie paranoid thinking.~   "
14282|NCT03379961|"~     Social Sorting is a: non interventional, observational, qualitative and multicenter research.~     It investigates three French emergency units in three French centers (UH of Angers, H of Le~     Mans, H of Laval).~      It is a research based on nursing sciences and social-psychology and it proposes to study the~     process of social categorization that intervenes during triage nursing.~      The process of social categorization has developped since the beginning of XX century~     (LIPPMANN, in 1922, in United States, he gave the first definition of stereotype// DURKHEIM,~     in France described step by step the individuals and the collectives representations.~      During XX century the social psychology developed a lot of studs about group dynamics (social~     categorization, influence phenomenon, conspiracy theories,...) within several domains :~     industry, politics, public services as police, social units,... and also in healthcare (but~     always about a social categorisation in particular and often with a limited study of~     impacts).~      Social Sorting includes all social categorization as possible and search to do a scientific~     evaluation of their impact.~   "
14260|NCT03380247|"~     The prevalence of pain in the emergency department is estimated between 60% and 78%. However,~     many studies reported oligo analgesia in about half of patient admitted to the emergency~     department. The delay before effective analgesia is one of the main causes of oligoanalgesia.~     The use of nurse-directed protocol allows the administration of analgesic upon admission to~     the emergency department. Nevertheless the need of intravenous access may delay analgesia.~     The use of oral form analgesics even with immediate release does not allow effective~     analgesia before 20 min. Pain management protocol in the emergency reception desk of CHU~     Grenoble Alpes (CHUGA) includes paracetamol that can be combined with oxycodone tablets~     depending on the pain intensity. For any mono traumatized it is possible to associate~     self-administer methoxyflurane inhaler. The pain management protocol is already used in the~     emergency reception desk of CHU Grenoble Alpes.The different analgesics( paracetamol,oral~     oxycodone, methoxyflurane) are already administered as part of routine care.The use of these~     different analgesics means would allow a rapid and adapted effectiveness to the pain~     intensity. However, there are no data on the efficacy and acceptability of such an early~     multimodal analgesia protocol in the emergency department.~   "
14261|NCT03380234|"~     This is a school- and family-based prospective study in randomly selected clusters among~     Primary/Grade 3-4 (P3-4) students in all the 5 regions of Hong Kong, which aims at reducing~     children's exposure to secondhand and thirdhand smoke. This study includes a baseline~     screening survey (to identify eligible subjects), baseline assessments (including hair~     nicotine analysis and child-reported outcomes), interventions and 12-month follow-up~     assessments.~   "
14262|NCT03380221|"~     The goal of the proposed study is to determine the effects of fresh watermelon fruit~     consumption on satiety, metabolic parameters and weight management.~   "
14263|NCT03380208|"~     The purpose of this clinical research is to compare new methods of identifying the locations~     of tumours to standard CT imaging. Analysis of the tissue removed during surgery (pathology)~     will be used to determine which method is more accurate. Accurately identifying the locations~     of tumours is especially important for radiation therapy, where the radiation needs to cover~     the entire tumour while minimizing the amount normal tissue that is exposed to radiation. The~     new method uses optical imaging (endoscopy) that can be mapped to the CT imaging using device~     tracking technologies. CT imaging is used to create the radiation treatment plans and so~     tumour locations are normally provided by CT images. The advantage of the new technology that~     is being tested is that it may be able to locate regions of a tumour that are at the surface~     of the tissue. These tumours are difficult to see using CT imaging but easy to see using~     optical imaging. Currently, there is no accurate way of mapping the optical imaging to the CT~     images used in radiation therapy.~      This study will enable the investigators to test the new optical imaging by comparing the~     tumour that the investigators identify using CT imaging alone against using CT imaging plus~     the optical imaging technology. The results from this imaging will be compared to pathology~     findings.~   "
14264|NCT03380195|"~     The purpose of this study was to determine the effects of a pre-exercise, single practical~     dose of watermelon juice, Gatorade, sugar water or water on heart rate recovery, blood~     lactate levels, and 24-hour post exercise muscle soreness.~   "
14265|NCT03380182|"~     The specific aim of this study is to determine the incidence of post-operative nausea and~     vomiting (PONV) in the pediatric population undergoing outpatient middle ear surgery.~   "
14266|NCT03380169|"~     Background: Ionic silver-containing dressing has been proven as a broad spectrum~     antimicrobial agent to reduce inflammation of wounds and promote healing. However, surgical~     incisions are usually dressed with conventional gauze dressing in colorectal surgery.~      Objective: To compare the effectiveness in preventing surgical site infection (SSI) by using~     conventional gauze dressing and occlusive ionic silver-containing dressing.~      Methods: This is a single-blind two-arm parallel randomized controlled trial on occlusive~     ionic silver-containing dressing conducted in Surgery Department of Princess Margaret~     Hospital. Two hundred patients who undergo emergency or elective abdominal colorectal surgery~     will be recruited and randomly assigned to have the surgical incisional wound dressed with~     conventional gauze dressing or occlusive ionic silver-containing dressing. Subjects will be~     assessed for SSI on day 3, 15 and 30 after operation in a clinical visit followed by phone~     interviews.~   "
14267|NCT03380156|"~     Heart failure (HF) is the leading cause of hospitalization in the US. Endothelial~     dysfunction, characterized by the decreased vasodilatory capacity of the vascular~     endothelium, is rampant in atherosclerotic diseases such as coronary artery disease and also~     in HF. Endothelial dysfunction also correlates with HF severity, progression, and mortality.~     It is postulated that endothelial dysfunction may in part be due to enhanced sympathetic~     drive, diminished parasympathetic drive, chronic inflammatory state thereby leading to~     reduced nitric oxide synthase activity in the vascular endothelium. Low-level vagus nerve~     stimulation (LLVNS) is an invasive way to modulate autonomic tone. Recent experimental and~     clinical data suggest that low-level transcutaneous vagal stimulation (TVS) (by stimulating~     the auricular branch of the vagus nerve located at the tragus of the external ear) may~     produce the same desired neuromodulator effect compared to LLVNS. The objective of this study~     is to determine the impact of TVS on endothelial dysfunction and arterial stiffness. The~     study population will include patients with chronic HFrEF. After performing baseline~     flow-mediated dilation (FMD), laser speckle contrast imaging(LSCI) and pulse wave analysis~     (PWA) testing, patients will be randomized to TVS or sham stimulation with a crossover design~     at different time points. The patient randomized to TVS arm will undergo stimulation for 1~     hour followed by immediate measurement of FMD,LSCI and PWA. There will be a washout period of~     at least 24 hours with patient crossing over to the other arms thus serving as their~     self-control.~   "
14268|NCT03380143|"~     This study will evaluate the impact of a whole-of-community multi-level adaptive systems~     intervention on implementation of community change and youth population physical activity.~     Building on local health department partnerships, the investigators will conduct a two-wave~     staggered-start community randomized trial with four volunteer rural communities (each having~     nested school, after-school, scouting/4-H club, youth sport organizations) randomly assigned~     to intervention or standard public health practice.~   "
17396|NCT03339258|"~     This randomized, double-blind, placebo-controlled trial of doxazosin will assess doxazosin's~     effectiveness for PTSD nightmares, subjective sleep quality, and non-nightmare PTSD symptoms~     in adult men and women veterans with full and partial-syndromal PTSD.~   "
14269|NCT03380130|"~     The purpose of this study is to evaluate the effect of the anti-programmed death 1 (PD-1)~     agent nivolumab following selective internal radiation therapy (SIRT) for patients with~     unresectable hepatocellular carcinoma (HCC).~      SIRT using yttrium90-loaded microspheres is increasingly used to treat patients with HCC,~     particularly those that are not good candidates for transarterial chemoembolization or TACE.~     SIRT induces disease control (objective tumor remission or stabilization) in most patients~     while progression usually results from the growth of new lesions. SIR-Spheres are resin-made~     microspheres used for SIRT.~      On the other hand, nivolumab is under clinical development for the treatment of more advanced~     HCC. Available data in patients that mostly had progression to other therapies and vascular~     involvement or metastatic disease show significant systemic antitumor activity that results~     in durable objective remissions and disease stabilizations.~      Therefore, in patients with HCC that has not spread beyond the liver, the systemic action of~     nivolumab may improve the anti-tumor effect of SIRT. Furthermore, by inducing immunogenic~     tumor cell death, SIRT may have a synergistic effect with nivolumab.~   "
14270|NCT03380117|"~     Electronic Bridge to Mental Health for College Students (eBridge) is an online intervention~     that screens students for mental health concerns that include elevated suicide risk and~     facilitates their linkage to mental health (MH) services. EBridge is designed to work on~     computers, tablets, and smartphones (iOS, Android) and is easily adaptable to evolving~     technologies in the future. It incorporates motivational interviewing (MI) principles and~     draws from health behavior models that emphasize autonomy and self-determination. Following a~     web-based screen using standardized scales to identify students at elevated risk, eBridge~     offers students options for personalized feedback (provided online in a conversational format~     adherent with motivational interviewing) and corresponding online with professionals trained~     in motivational interviewing and knowledgeable about university and community resources.~     Ebridge is being conducted at four universities: the University of Michigan, the University~     of Nevada-Reno, the University of Iowa, and Stanford University.~   "
14271|NCT03380104|"~     The purpose of the study is to test the effects of intradural, spinal cord stimulation using~     a device placed in the same manner as a lumbar drain performed during a standard epidural~     spinal cord stimulation (SCS) trial routinely performed prior permanent lead and stimulation~     device implantation.~   "
14272|NCT03380091|"~     Open-label randomized clinical trial assessing the efficacy of Metformin versus Vitamin D in~     improving symptoms of depressed mood in polycystic ovary syndrome.~   "
14273|NCT03380078|"~     The purpose of this study is to test the effectiveness of the Translating Evidence-based~     Interventions (EBI) for ASD: Multi-Level Implementation Strategy (TEAMS) model on~     provider-level implementation outcomes when used to enhance provider training in two~     evidence-based interventions for children with autism spectrum disorder (ASD). The TEAMS-~     Leadership Institute (TLI) module includes training to program/school district leaders in~     implementation of EBI, and the TEAMS Individualized Provider Strategy for Training (TIPS)~     module applies Motivational Interviewing strategies to facilitate individual provider~     behavior change. TEAMS will be tested in combination with two clinical interventions in two~     community service setting contexts (1) AIM HI intervention in mental health programs and (2)~     CPRT intervention in schools. It is expected that the addition of TLI and / or TIPS will~     improve use of EBI by community providers.~   "
14274|NCT03380065|"~     Coronary angiography is now mainly performed via the radial route rather than the femoral~     route. At the end of the procedure, the sheath is removed and a band is inflated to obtain~     hemostasis. The air in the band is then deflated at regular intervals. Currently there are~     different protocols for deflation of the band, but none of these have been studied with~     regards to patient comfort and time of deflation, and potential complications such as~     bleeding. Here in this study the investigators wish to compare two such protocols of band~     deflation and assess the levels of patient comfort and time to discharge with two widely used~     protocols.~   "
14275|NCT03380052|"~     To validate OLGA and OLGIM staging system for estimating GC risk according to Lauren's~     histologic classification in South Korea. Also attempted to estimate synergistic interaction~     among the several risk factors to help establish surveillance strategy.~   "
14276|NCT03380039|"~     A single arm, open-label pilot study is designed to determine the safety, efficacy and~     cytokinetics of CAR-BCMA T cells in patients with BCMA-positive refractory or relapsed~     multiple myeloma.~   "
14277|NCT03380026|"~     This is a two-arm, open-label study that aims to compare the incidence and severity of the~     most common adverse reactions, particularly contact dermatitis, when Valchlor is used alone~     or in conjunction with triamcinolone ointment 0.1% in early stage MF subjects (Stage IA and~     IB) for a period of 4 months.~   "
14278|NCT03380013|"~     The goal of this study is to determine if infants with neonatal encephalopathy will achieve~     full oral feeds faster after therapeutic hypothermia has completed if they are treated with~     osteopathic manipulative treatment. The treated infants will be compared to matched~     historical controls.~   "
14279|NCT03380000|"~     In this study the investigators will test the hypothesis that acute consumption of inorganic~     nitrate (supplied in concentrated beetroot juice) reduces artery stiffness and resting blood~     pressure, and lessens the rise in blood pressure during handgrip exercise in postmenopausal~     women. Understanding and improving artery function and blood pressure regulation in women is~     important because they undergo accelerated arterial stiffening after menopause and have much~     larger increases in blood pressure when they exercise compared with either premenopausal~     women or men of similar age.~   "
14280|NCT03379987|"~     The investigator will test the analgesic efficacy of paravertebral morphine as an adjuvant to~     local anesthetics for acute postoperative pain following breast surgery and renal surgery~   "
14281|NCT03379974|"~     Individuals with mild hemophilia A (MHA) bleed infrequently but can in the setting of trauma~     which often is when participating in sports/exercise. Although both exercise and DDAVP~     (desmopressin) can raise Factor 8/Von Willebrand Factor (FVIII/VWF levels), it is not clear~     whether the pathophysiological mechanism is the same. Consequently it is not known if DDAVP~     and exercise would have additive effects in raising FVIII:C and VWF levels or if one would~     one negate the effect of the other. The aim of this 2 center (Sickkids and Nationwide~     Children's), prospective, cross-over design study is to compare the impact of exercise vs.~     DDAVP on hemostasis in patients with MHA and also to investigate the impact of sequentially~     administering these interventions on their hemostatic indices.~   "
14284|NCT03379935|"~     Fractures of the radial head are among the most common fractures in the elbow and represent~     one-third of all elbow fractures.This retrospective cohort study was performed between 2004~     and 2014 at Sundsvall and Umeå University hospital, Sweden. All patients who were operated on~     between 2004 and 2014 with a radial head arthroplasty for an acute or sequelae due to a caput~     radii fracture.The aim of this study is to evaluate clinical or radiological differences~     between patients treated with a unipolar or bipolar radial head arthroplasty.~   "
14285|NCT03379922|"~     Extracorporeal shockwave lithotripsy is an outpatient treatment for patients with intrarenal~     calculi. Standard of care involves offering oral analgesia prior to commencing the treatment.~     Most patients do not take the offered analgesia after the initial treatment. It has been~     suggested that distraction techniques may be equivalent to oral analgesia in improving~     tolerability of extracorporeal shockwave lithotripsy treatment. The use of distraction~     techniques also removes the potential side effects of mediation administration.~   "
14286|NCT03379909|"~     A multi-center, open-label, phase II clinical study of metformin in up to evaluable 49~     patients with low-grade NMIBC with the aim to determine the overall response to~     administration of oral metformin for 3 months in a marker tumour deliberately left following~     transurethral resection of multiple, papillary NMIBC tumours.~   "
14287|NCT03379896|"~     Study on antigen-presenting function of gamma delta T cells in sepsis and its molecular~     mechanisms~   "
14288|NCT03379883|"~     The social impact of degenerative diseases such as articular cartilage pathology and~     osteoarthritis (OA) is steadily increasing, because of the continued rise in the mean age of~     the active population. A variety of noninvasive solutions have been proposed for pain~     treatment, improvement in function and disability, and ultimately, modification of the course~     of severe cartilage lesions and OA, with variable success rates. Intra articular and~     genicular nerves radiofrequency (RF) is a minimally invasive technique that usually aims at~     the neuropathic pain. One important mechanism for the chronic pain mediated by OA is~     peripheral sensitization, which increases the transmission of pain signals. Through~     conduction block in pain-transmitting nerve fibers by thermal damage, RF could ease pain~     without destroying the antennal nerve. The role of growth factors (GFs) in chondral repair is~     now widely investigated in vitro and in vivo.~      Platelet-rich plasma (PRP) is a simple, low cost, and minimally invasive method that allows~     one to obtain from the blood a natural concentrate of autologous GFs.~   "
14289|NCT03379870|"~     Purpose: Routine clinical care and pilot study data has shown evidence of postoperative~     hearing preservation in pediatric cochlear implant (CI) recipients. The primary aim of this~     study is to investigate speech perception performance in pediatric CI recipients with~     functional pre-operative hearing.~      Participants: Two cohorts of CI recipients aged 6 through 17 years who had pre-operative low~     frequency residual hearing. Subjects in Arm 1 will present with a post-operative low~     frequency pure tone average (125, 250, and 500 Hz) of ≤ 75 dB HL, and those in Arm 2 will~     present with a post-operative low frequency pure tone average (LFPTA) that exceeds 75 dB HL.~      Procedures (methods): Subjects will complete speech perception and quality of life testing~     during post-operative intervals. Subjects in Arm 1 will be evaluated with the cochlear~     implant alone (CI-alone) and with combined electric-acoustic stimulation (EAS). Subjects in~     Arm 2 will be evaluated with the CI-alone.~   "
14290|NCT03379857|"~     Incidence of strokes has increased these last 20 years in young population. This rise could~     be linked to alcohol, tobacco or drug use like cannabis. Cannabis has previously been~     descripted as a potential factor of reversible vasoconstriction. The main objective is to~     show that an exhaustive assessment of a stroke facing a young person frequently lead to a~     diagnostic of reversible vasoconstriction due to cannabis use. Evaluation will focus on~     prevalence of strokes secondary to a reversible vasoconstriction attributable to cannabis in~     young subjects.~      There's a real public healthcare interest in terms of primary and secondary prevention to~     evaluate the role of cannabis as a risk factor of stroke in young population.~   "
14291|NCT03379844|"~     Patients with hepatocellular carcinoma often die from intrahepatic disease since current~     treatment options are generally limited. Local treatment using holmium radioembolization~     could offer an effective treatment and a more personal approach than yttrium~     radioembolization (standard-of-care) as holmium has more imaging options.~   "
14292|NCT03379831|"~     Congenital heart disease (CHD) is the most common congenital malformations. The right~     ventricle in the sub-aortic position, or systemic right ventricle is one of these complex~     cardiac diseases. Several studies show that adults with CHD and especially systemic right~     ventricle have reduced exercise capacity. In addition, studies have shown that there is a~     correlation between alteration of aerobic physical capacity and alteration of right~     ventricular systolic function.~      Understanding and assessing the determinants of the physical capacity of patients with~     systemic right ventricles and evaluating their quality of life could allows us to improve~     their therapeutic management and also to expand patient indications to a program cardiac~     rehabilitation. This can benefit them on their exercise capacity, their tolerance to exercise~     and their quality of life.~      The aim is to study the correlation between the quality of life and the aerobic physical~     fitness of patients with a systemic right ventricle and to determine the clinical and~     paraclinical parameters that have an impact on the aerobic physical fitness of these~     patients. The quality of life of patients with a systemic right ventricle will be compared to~     that of the general population.~   "
14293|NCT03379818|"~     Most studies regarding word learning have focused on understanding when and how infants learn~     words. At 24 months, typically developing infants know between 200 and 300 words and add new~     words to their vocabularies at a rapid rate. It is also during the first years of life that~     some principles that promote vocabulary learning are developed. The shape bias, which is a~     tendency to infer that objects that share the same shape will also share the same name, is~     the one that has been studied the most. At 24 months, typically developing infants use this~     principle as a strategy to learn novel words. In contrast, Late Talkers (children with a~     language delay in the absence of a physiological, cognitive or genetic disorder that may~     account for this delay) do not exhibit this preference. It has been found that teaching~     typically developing infants a shape bias prior to the end of the second year of life can~     boosts their word learning. Despite this, the possibility of teaching Late Talkers this~     principle and its effect on their vocabulary and language development has not been explored.~      Over a series of 9 weekly sessions, Late Talkers (diagnosed by Language Therapists from the~     Birmingham Community Healthcare National Health Services Foundation Trust, United Kingdom)~     will be introduced to one of two possible interventions: a shape bias intervention and a more~     conventional intervention called specific word intervention. Both interventions will be~     compared after 9 weeks. One year later, a follow up study will be conducted to assess the~     long-term effects each intervention has in word learning. Participants will be referred by a~     Speech and Language Therapists from the Birmingham Community Healthcare National Health~     Services Foundation Trust, United Kingdom, and all assessments and interventions will take~     place at the Infant and Child Lab at the University of Birmingham, United Kingdom.~   "
14294|NCT03379805|"~     The lymphatics regulate the interstitial fluid by removing excessive fluid. It represents an~     extremely important step in the prevention of edema. The Fontan-Kreutzer procedure has~     revolutionized the treatment of univentricular hearts. However, it is associated with severe~     complications such as protein-losing enteropathy (PLE) and peripheral edema that may involve~     the lymphatic circulation.~      Our hypothesis is that patients with a univentricular circulation have a reduced~     functionality of the lymphatic vasculature, which predisposes them to developing~     complications such as edema and PLE.~      The functional state of lymphatics is investigated using near infrared fluorescence imaging,~     NIRF. The anatomy is described using non-contrast MRI and the capillary filtration rate is~     measured using plethysmography.~   "
14295|NCT03379792|"~     The purpose of this study is to compare the metabolic phenotype of a range of body weights in~     individuals with and without Type 1 diabetes.~   "
14296|NCT03379779|"~     A prospective observational study. Enrolled participants admitted to ICU due to pneumonia and~     respiratory failure need mechanical ventilator support. Investigators collected the residual~     specimens, such as sputum from endotrachea aspiration, bronchoalveolar lavage fluid in those~     participants as the usual care in the ICU. Those residual samples were sent to extract RNA~     and sequence by using high-throughput sequencing (next-generation sequencing) method.~      Investigators will compared the microbiome feature between lower respiratory tract and stool~     specimens in those participants diagnosed as pneumonia with respiratory failure.~   "
14297|NCT03379766|"~     Phonak Hearing Systems pass through different development and study stages. At an early~     stage, feasibility studies are conducted to investigate new algorithms, features and~     functions in an isolated manner. If the benefit is proven, their performance is then~     investigated regarding interdependency between all available algorithms, features and~     functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a~     result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing~     Systems undergo a final quality control in terms of clinical trials. This is a pre-validation~     study, investigating optimized algorithms, features and functions. This will be a clinical~     evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa~     (Switzerland).~   "
14298|NCT03379753|"~     This study is to determine if patients following prolapse repair including vaginal vault~     suspension have decreased pain measured via a visual analog scale (VAS) on postoperative day~     one and just prior to discharge when exposed to the diad of music and positive images~     compared to patients receiving standard care.~   "
14299|NCT03379740|"~     This is a single-center, open-label, concentration-ranging study to evaluate the nicotine PK~     profile and PD effects in healthy adult experienced users of closed tank/cartridge~     e-cigarettes using four different variants of P4M3 (nicotine concentration of 1.7%, 1.7% with~     1.1% lactic acid [LA], 3% with 1.1% LA, and 4% with 2% LA) or their own e-cigarettes.~   "
14300|NCT03379727|"~     The purpose of this study is to gather and evaluate additional safety and efficacy data on~     the combination of midostaurin and standard of care for adult patients with newly diagnosed~     Fms-like tyrosine kinase receptor (FLT3) mutated Acute Myeloid Leukemia (AML) who are~     eligible for standard induction and consolidation~   "
14301|NCT03379714|"~     Flow disruption is a new endovascular approach for treatment of both ruptured and unruptured~     intracranial aneurysms, which involves placement of an endosaccular device (WEB) which~     modifies the blood flow at the level of the neck and induces intraaneurysmal thrombosis. The~     WEB was designed to treat wide-neck bifurcation aneurysms. This observational study will~     collect data about the routine practice in one center of using the WEB in ruptured and~     unruptured intracranial aneurysms. The primary objective is to evaluate its efficacy by~     assessing the anatomic outcome during follow-up.~   "
14302|NCT03379701|"~     Professor Hossam Haick from the Technion, developed an electronic nose for diagnosis of~     diseases via breath samples.~      Biomarkers from nose and sinuses and upper respiratory tract can be detected by electronic~     nose.~      Identification of biomarkers from nose and sinuses and upper respiratory tract can~     differentiate between the subtypes of CRS (Chronic rhinosinusitis) and may serve as markers~     for disease (vs controls), of disease activity (predicting aggressive disease course,~     predicting Malignant vs Benign nasal polyps, as inverted papillpma or carcinoma; predicting~     response to therapy (Steroid , Antibiotics, Nasal wash, Surgery).~   "
14303|NCT03379688|"~     The objective of the explorative registry study is to investigate outcome parameters in the~     routine treatment of patients who are monitored after heart surgery for either short or~     long-term treatment in the intensive care unit for close monitoring of blood pressure.~   "
14304|NCT03379675|"~     The purpose of this study is to explore the antiviral effect of JNJ-53718678 at 2 dose levels~     (80 milligrams [mg] and 500 mg) once daily for 7 days in adults with Respiratory Syncytial~     Virus (RSV) infection, as measured by RSV viral load in nasal secretions by quantitative~     reverse transcription polymerase chain reaction (qRT-PCR) assay.~   "
14305|NCT03379662|"~     The purpose of this study is to determine whether the Erchonia EAL Laser is effective in the~     treatment of irritability associated with autistic disorder in children and adolescents aged~     five (5) to seventeen (17) years.~   "
14306|NCT03379649|"~     Patients with recurrent implantation failure are among the most difficult patients to treat,~     with no proven standard treatment. Platelet rich plasma stimulates cellular processes~     involved in endometrial regeneration, and in a small case series has shown efficacy for this~     patient population. We hope to conduct a randomized controlled pilot study to determine~     whether PRP is indeed an effective treatment for recurrent implantation failure.~   "
14319|NCT03379480|"~     Despite the preliminary evidence, yoga as a treatment for schizophrenia is~     under-examined.Studies in healthy individuals indicate yoga practices to~     improveself-reflection. However, whether yoga treatment improves impairments in self-~     reflection typically seen in patients with schizophrenia is not examined. Hence, In this~     study we aim to examine whether yoga is efficacious as an add-on treatment in Schizophrenia~     in a randomized multi-centric trial and also whether yoga improves self-reflection in~     patients with schizophrenia.~   "
14354|NCT03379025|"~     This study evaluates the effects of electronic cigarette use on cigarette smoking and markers~     of tobacco use, as well as respiratory symptoms and function in smokers with mild to moderate~     chronic obstructive pulmonary disease (COPD). All participants will receive a 12 week supply~     of electronic cigarettes to use instead of their regular conventional cigarettes.~   "
14307|NCT03379636|"~     Kinesiotape (KT) is widely used in musculoskeletal rehabilitation as an adjuvant to treatment~     but minimal evidence supports its use. The aim of this study is to determine the immediate~     and short-term effects of shoulder KT on muscular activity, mobility, strength and pain after~     rotator cuff surgery. Our hypotheses were that KT should not improve muscle function,~     mobility, strength or pain in a clinically meaningful way.~      Methods: Thirty-nine subjects with shoulder rotator cuff surgery were tested 6 and 12 weeks~     post-surgery, without tape, with KT and with a sham tape (ST). KT and ST were applied in a~     randomized order. For each condition, muscular activity of upper trapezius, three parts of~     deltoid and infraspinatus during shoulder flexion, range of motion (ROM) and pain intensity~     were assessed. At 12 weeks, isometric strength at 90° of shoulder flexion, with related~     muscular activity and pain intensity were also measured. Subjects maintained the last tape~     applied for three days and recorded pain intensity at wake-up and during the day.~   "
14308|NCT03379623|"~     The overall aim of this study is to develop an evidence based exercise programme for the~     management of knee osteoarthritis which is feasible and acceptable to patients and healthcare~     professionals in Malaysia. The chosen programme was identified through a systematic~     literature search and is the programme developed by Hurley et al. in 2007. This programme~     will be evaluated through mixed-methods sequential exploratory design research study guided~     by the United Kingdom (UK) Medical Research Council guidance and framework. It involves two~     phases of data collection. The first phase (already completed) comprised a qualitative study~     aimed at exploring the beliefs and attitudes of Malaysian people that would need to be taken~     into account when adapting the evidence based ESCAPE-pain (acronym for 'Enabling~     Self-management and Coping with Arthritic pain using Exercise) programme for implementation~     in the context of Malaysian healthcare system. The second phase will be conducted to evaluate~     the feasibility of trialling ESCAPE-pain programme in Malaysia.~   "
14309|NCT03379610|"~     To evaluate the sensitivity and specificity of the combination of EBV and methylation marker~     genes in body fluids of both plasma and nasopharyngeal brush together for screening of early~     salvageable local residual and recurrent NPC that are missed by conventional clinical~     follow-up protocol.~   "
14310|NCT03379597|"~     In this study, the investigators will evaluate the efficacy, safety and related mechanism of~     probiotics as a add-on treatment in improving the antipsychotic induced weight gain, the~     cognitive impairment, and psychotic syndrome in first episode schizophrenia patients. The~     study will recruit 40 first episode schizophrenia patients who meet the criteria of DSM-5,~     and then randomized to probiotics group or control group for a 8-weeks clinical trail. The~     specific aims are to compare probiotics group versus controls on: 1) clinical core symptoms;~     2) cognition;3)metabolic related markers.~   "
14311|NCT03379584|"~     This study will test the safety and activity of SGN-CD48A given every 3 weeks to patients~     with multiple myeloma.~   "
14312|NCT03379571|"~     Although chronic kidney disease (CKD) affects a growing number of people, epidemiologic data~     on incident CKD in the general population are scarce. Screening strategies to increase early~     CKD detection have been developed.~      Methods: From a community-based sample of 4,409 individuals residing in a well-defined~     geographical area, investigators determined the number of patients having a first serum~     creatinine value ≥1.7 mg/dL and present for at least 3 months that allowed us to calculate an~     annual incidence rate of CKD (stages 3 to 5). CKD (stages 3 to 5) was defined by estimated~     glomerular filtration rate (eGFR) <60 mL/min/1.73 m2. Investigators also described the~     primary care, outcomes and risk factors associated with outcomes using competing risks~     analyses for these CKD patients.~   "
14313|NCT03379558|"~     Primary Objective:~      To estimate the overall combined rate of major structural birth defects in infants of mothers~     with atherosclerotic cardiovascular disease (ASCVD) and/or familial hypercholesterolemia (FH)~     exposed to Praluent® (alirocumab) during pregnancy when used to treat hypercholesterolemia~     and to compare that rate to unexposed disease-matched and unexposed non-diseased comparison~     pregnancies.~      Secondary Objectives:~        -  Secondary objectives are to estimate the rates of the outcomes in pregnancies/infants of~          mothers with atherosclerotic cardiovascular disease and/or familial hypercholesterolemia~          exposed to alirocumab during pregnancy when used to treat hypercholesterolemia and to~          compare that rate to unexposed disease-matched and non-diseased comparison pregnancies,~          and secondarily to compare the rates of these outcomes in the unexposed disease-matched~          pregnancies to the rates in the unexposed non-diseased comparison pregnancies.~        -  Safety and tolerability of alirocumab.~   "
14314|NCT03379545|"~     This study aims to assess the efficacy of three-dimensional magnetic resonance (MR) compared~     to three-dimensional computed tomography (CT) imaging. This proposed study is a prospective,~     unrandomized, single-blinded, self-controlled, and single-armed diagnostic radiological~     evaluation study.~   "
14315|NCT03379532|"~     Stroke patients with severe upper limb movement deficits have limited treatment options and~     often remain severely handicapped at the chronic stage.~      Recent findings have suggested that poor motor recovery can be due to severe damage of the~     cortico-spinal tract (CST), the neural fibres connecting the movement regions of the brain to~     the spinal cord. Hence, to improve recovery of upper limb movements it will be crucial to~     re-establish and strengthen CST projections.~      Recent studies provided evidence that closed-loop brain computer interface-driven electrical~     stimulation of the paretic muscles can induce clinically important and lasting recovery of~     upper limb function, even in patients with chronic, severe motor affection. In this treatment~     approach, movement intentions of the patients are detected with electroencephalography and~     real-time analyses. This triggers an electrical stimulation of affected upper limb muscles.~      In this study, the investigators hypothesize that neuromuscular electrical stimulation (NMES)~     applied contingent to voluntary activation of primary motor cortex, as detected by a~     brain-computer interface (BCI), can help restore CST projections. This might improve recovery~     of patients with severe upper limb movement deficits. Treatment will be started within the~     first 8 weeks after stroke onset.~   "
14316|NCT03379519|"~     This study sought to investigate the changes in attention in older adults with mild cognitive~     impairment after Multi-domain Attention Training .~   "
14317|NCT03379506|"~     The purpose of this study is to assess the pharmacokinetics (PK), safety, and efficacy of~     MK-5172, a fixed dose combination (FDC) of elbasvir (EBR) and grazoprevir (GZR) in pediatric~     hepatitis C virus (HCV)-infected participants aged 3 years up to 18 years.~   "
14320|NCT03379467|"~     Pakistan has one of the highest infant mortality rates in the world. One child in eleven dies~     before their fifth birthday. In part, this is due to the low coverage rate of routine~     childhood immunizations. Since Pakistan is a Low Middle Income Country (LMIC) it is essential~     that an immunization intervention be developed that is suitable for its socioeconomic~     setting. The tele-density of Pakistan exceeds 70% and the cost of SMS in Pakistan is very~     low. Moreover the use of SMS in the country has broadened beyond the conventional use of~     peer-peer chat to include social networking, SMS banking, delivery tracking, advertising,~     business, disaster management, and identity verification. This study will utilise this~     prevalence of mobile phones to assess whether simple and interactive sms reminders can serve~     to increase childhood immunization coverage and timeliness.~      The pilot study will be carried out only in 2 EPI (Extended program on Immunization) centers~     at Korangi. The pilot will determine whether automated text messages produce increased~     immunization coverage in the reminder groups compared to the control group. 656 participants~     will be enrolled at Penta-1 and will be followed up until measles-2 vaccination. The results~     of proposed pilot will provide the basis for a large scale-up study in urban and rural~     settings in Pakistan.~   "
14321|NCT03379454|"~     An observational, non-interventional registry study to collect real-world data from people~     living with melanoma and its treatment, which will be available to researchers to further the~     knowledge of melanoma and improve patient care.~   "
14322|NCT03379441|"~     Maintainance therapy in patients with unresectable stage III, NSCLC Stage IIIA-B,~     unresectable, NSCLC, treated with definitive Chemo-Radiotherapy~   "
14323|NCT03379428|"~     This is a Phase I/II, open-label dose-escalation study designed to evaluate the maximum~     tolerated dose (MTD) and dose-limiting side effects of ibrutinib (560 or 840 or 420 mg daily~     oral dose), given in combination with trastuzumab administered through the vein, in patients~     with HER2-amplified Metastatic Breast Cancer that has gotten worse after prior therapy with~     ado-trastuzumab emtansine (T-DM1).~   "
14324|NCT03379415|"~     Injuries to the meniscus are common in sport. A meniscectomy is often performed to manage~     symptoms associated with the meniscal injury. Following a meniscectomy individuals are highly~     likely to develop knee osteoarthritis (OA). Footwear interventions have demonstrated~     biomechanical changes during walking and running, in healthy and individuals with~     osteoarthritis. With the increased risk of developing OA associated with meniscectomy~     patients, understanding biomechanical changes with footwear when compared to healthy~     individuals, may provide a conservative approach to delaying or minimising the development of~     (OA). There is no current literature assessing the effect footwear has post meniscectomy, so~     this is a very novel approach and can yield important results for the management of future~     risks. Current evidence supports the use of footwear interventions aiming to minimise OA~     progression in older adults during walking. Yet, meniscectomy patients who have sustained an~     injury during sport are likely to continue to participate in sport following treatment in~     their usual footwear. Further evidence is required to better understand the effect of~     footwear interventions during dynamic movements often performed in sport. Previous studies~     have assessed customised footwear interventions, however these interventions are not~     representative of commercially available interventions that could be widely used by the~     general population. Therefore assessing commercially available footwear will give a more~     realistic approach to conservative treatment for meniscectomy patients. This project aims to~     examine biomechanical differences between commercially available footwear conditions in~     healthy individuals and individuals who have had a meniscal injury. Three-dimensional kinetic~     and kinematic measures will be assessed during five tasks (walking, running, 90 degrees side~     cut, single leg landing, and small knee bend squat), for different footwear conditions.~   "
14325|NCT03379402|"~     This is an observational study to evaluate the utility of the latest recommendation to define~     severity of infection for sepsis patients (sepsis-3), and to identify the aetiology and~     factors associated with outcome of community-acquired sepsis in Northeast Thailand.~      Potential study participants will be adult patients who are presented at the hospital with~     community-acquired sepsis. Clinical specimens (including blood, urine, sputum, throat swabs~     and pus or wound swab) will be collected from each participant on admission for culture, PCR~     and serological tests, and other laboratory tests. Participants' treatment will be closely~     monitored during the duration of their hospital stay. Blood will be again collected at 72~     hours after admission. Participants will be contacted at 28 days after admission to determine~     clinical outcome by phone interview with standardized script.~   "
14326|NCT03379389|"~     This is a double-blind, randomized, double-dummy, comparative study in parallel groups of~     subjects presenting with recurrent cystitis (≥2 episodes within the past 6 months). Subjects~     will be randomized and treated with one of two presentations of urinary antiseptics~     containing methenamine and methylthioninium for three days, followed by three days of~     antibiotic therapy as determined by urine culture and antibiogram. This study aims to assess~     the efficacy and safety of each treatment.~   "
14327|NCT03379376|"~     This trial determines how well eHealth mindful movement and breathing works to improve~     outcomes in participants undergoing gynecologic surgery. Supportive therapy, such as eHealth~     mindful movement and breathing, uses techniques that include gentle movements, breathing, and~     relaxation techniques which may help participants cope with and improve their surgical~     experiences.~   "
14328|NCT03379363|"~     This retrospective, multi-center, chart review study will collect patient data from medical~     charts of pediatric patients who have been treated with Korlym for Cushing's syndrome.~   "
14329|NCT03379350|"~     All patients undergo lateral thoracotomy or video-assisted thoracoscopic surgery (VATS) and~     are operated on by the same thoracic surgical team. All patients are managed with gravity~     drainage (water seal only, without suction) on the day of operation. Eligible patients are~     randomized to control group or clamping group at a 1:1 ratio before 3pm on the postoperative~     day. Patients in control group and those in clamping group are managed with different~     protocols after 3pm on the postoperative day.~   "
14330|NCT03379337|"~     The purpose of this study was to use the principle of fluorescence to identify oral diseases~     not readily visible to the naked eye. A imaging device with a removable and modular head~     consisting of arrays of Light Emitting Diodes (LEDs) with differing wavelengths (405nm,450nm~     or white) was used to image teeth to detect fluorescent biomarkers such as porphyrins~     associated with poor oral health (plaque). The process utilizes illumination of the teeth and~     gums using a specific array of LEDs in the visible and near-visible spectrum and is~     non-invasive. Successful implementation of the device would provide proof-of- concept~     validation for its use as a safe, rapidly deployable solution to assess oral hygiene.~   "
14331|NCT03379324|"~     Rotator Cuff (RC) repair will be augmented with the injection of a human amniotic fluid~     derived allograft at the repair interface junction. A secondary injection will be~     administered at the time of repair in the supraspinatus muscle body medial to the~     musculotendonous junction.~   "
14332|NCT03379311|"~     This is a Phase 1b, open-label, study to assess the effects of AK002, given as monthly~     intravenous infusion, at up to 1 mg/kg for 6 doses.~   "
14334|NCT03379285|"~     Gastro intestinal (GI) bleeding is relatively frequent and may lead to intensive care unit~     admission. Although a restrictive strategy for red blood cell transfusion is supported by a~     large randomized controlled trial literature, less is known about the impact of transfusion~     strategy of other blood components and administration of anti fibrinolytic on clinical~     outcomes.~      This study aims to identify parameters that may be associated with the risk of further~     bleeding in patients admitted to ICU for GI bleeding.~   "
14335|NCT03379272|"~     The proposed study is designed to evaluate the performance of the Neuronaute in comparison~     with the gold standard EEG in patients with a regular appointment at the hospital. The design~     of this study is guided by two overriding factors : (i) epileptics disorders suspected or~     either (ii) epileptics already diagnosed.~      Volunteers will be asked to participate to this study. This study will enroll 35 outpatient~     subjects aged 18 to 85. Informed consent will be obtained from the patients, and assent from~     the subjects, prior to any form of assessment or intervention as part of the study.~      Patients will be submitted to the studied device record Neuronaute following by the gold~     standard EEG.~      A grid with all EEG activity recorded during the trial will be provided for evaluation after~     completion of the trial.~   "
14336|NCT03379259|"~     BGB-A333 is a humanized IgG1-variant monoclonal antibody against programmed cell death~     1-ligand 1 (PD-L1), the ligand of an immune check point- receptor, programmed cell death-1~     (PD-1). BGB-A317 is a humanized, IgG4-variant monoclonal antibody against PD-1. This study~     tests the safety and anti-tumor effect of BGB-A333 alone and in combination with BGB-A317 in~     patients with advanced solid tumors.~   "
14337|NCT03379246|"~     This is a retrospective chart review using TriHealth Electronic Privacy Identification Center~     (EPIC) to determine whether gynecologic surgeons at a large community hospital are already~     meeting the recently recommended best practice of supporting the vaginal apex.~   "
14338|NCT03379233|"~     This study will evaluate the effect of dose tracking in conjunction with reminder~     notifications and motivational/adaptive messages on treatment adherence behavior in subjects~     with COPD. The effect will be measured over 24 weeks on the subject's on time treatment~     adherence and total treatment adherence. The dose tracking is done by the Concept2 inhaler~     and the reminder notifications, feedback on inhaler use and motivational messages are sent by~     the patient application.~   "
14339|NCT03379220|"~     This research aims to extend the application of spreading depolarization monitoring to~     non-surgical TBI patients, using intraparenchymal electrode arrays and scalp~     electroencephalography to detect depolarizations and develop less invasive monitoring~     methods.~   "
14340|NCT03379207|"~     Community acquired pneumonia (CAP) is a major cause of morbidity and mortality worldwide.~     Despite recent improvement in acute management (specifically for administration of~     antibiotics) many severe presentations of pneumonia worsen, progressing to Acute Respiratory~     Distress Syndrome (ARDS), a clinical entity with 40% hospital mortality.~      Dysregulation of immune response is thought to be largely implicated in severe pneumonia~     progressing to ARDS. Notably, experimental studies have recently suggested the implication of~     non-conventional T lymphocytes and innate cells in this immunopathology. However, no data are~     available in Humans in clinical settings.~      This study aims to explore the role of non-conventional T cells in pneumonia and ARDS, in~     participants. For this purpose, 100 participants admitted to Intensive Care Unit (ICU) with a~     diagnosis of CAP will be included, and 50 control participants with no pneumonia nor shock.~     Presence and functionality of non-conventional T cells and innate cells will be explored~     using flow-cytometry and ex-vivo stimulation, alongside with cytokines productions. These~     analyses are conducted in the blood, and, for invasively ventilated participants, in tracheal~     aspirates or broncho-alveolar fluids if available. For each participants included, the~     analyses are conducted at different time-points during ICU stay: inclusion, day 3, day 8 and~     day 15. Moreover, participants with ARDS, for whom a post-ICU follow-up program is normally~     established after discharge, will have blood analysis from blood samples taken during the~     follow-up visit up to 8 months after inclusion.~      Immunophenotypage and functionality of non-conventional T cells and innate cells will be~     compared to clinical parameters and their evolution, between CAP participants and Control~     participants, and for each participants, according to the different time-point of analysis,~     in order to better understand dynamic of innate immunity during pneumonia and ARDS.~   "
14341|NCT03379194|"~     Antibiotic resistance is an increasingly serious problem in Switzerland which is associated~     with the exposure and overall uptake of antibiotics in a population. Reduced antibiotic~     prescribing for outpatients is paralleled by a decrease in antibiotic resistance rates.~      In a recent pragmatic trial the investigators found only promising yet not very conclusive~     results as those were present only in some groups. This nationwide antibiotic stewardship~     program with routine feedback on antibiotic prescribing was not associated with an overall~     change of antibiotic use. In older children, adolescents, and younger adults less antibiotics~     were prescribed, but not consistently over the entire intervention period.~      Hence, the investigators now aim to evaluate a better tailored program to obtain a better~     understanding of the effects on patient-relevant outcomes, on antibiotic resistance, and of~     the underlying mechanisms leading to different effects in certain subgroups of patients.~      The investigators plan to evaluate a nationwide antibiotic stewardship program combining~     routine prescription feedback with the provision of physician and patient education material~     in primary care physician in Switzerland. The project is conducted within the framework of~     the National Program on antimicrobial resistance by the Swiss National Science Foundation.~   "
14342|NCT03379181|"~     The overall objective of the HEAT study is to determine the acute effect of propranolol on~     energy expenditure in patients suffering from hyperthyroidism and to evaluate the~     consequences of the change of hyper- to euthyroidism on metabolism during the course of~     treatment, especially with regard to the reaction to cold ambient temperatures.~   "
14343|NCT03379168|"~     Knee osteoarthritis (OA) causes patients considerable joint pain and leads to instability,~     reduced range of motion, and functional limitations. Current treatment limitations have~     generated interest in alternative options to restore function and alleviate joint pain, some~     with the aim of healing damaged articular cartilage. There has been preliminary support in~     the literature for reduced pain and improved functional performance in patients who receive~     mesenchymal stem cells (MSCs) as part of a treatment regimen. MSCs can be costly and are~     limited by complex regulatory issues. This interest in an alternative isolation method lead~     to the development of Lipogems. Lipogems is a technique to harvest, process, and inject~     minimally manipulated adipose tissue. This procedure is enzyme free and requires no clonal~     expansion or manipulation. The goal of this study is to evaluate the possible benefits of~     reduced joint pain and increased joint functionality in patients with knee osteoarthritis~     after the injection of Lipogems. In addition, given the limitations of prior research on the~     efficacy of intra-articular corticosteroids, the investigators will also include this as an~     additional study group to compare to placebo. There have been case reports published showing~     favorable outcomes. This would be the first study reporting data on the efficacy of Lipogems~     for pain relief in knee OA in a randomized, controlled clinical trial with a larger sample of~     patients.~      The investigators hypothesize that patients who receive an injection of Lipogems will~     experience a decrease in pain of the affected knee and an increase in joint functionality in~     comparison to placebo. The investigators also hypothesize that patients who receive an~     intra-articular corticosteroid will experience decreased pain or improved functionality in~     the affected joint compared to placebo.~   "
14344|NCT03379155|"~     The purpose of the study is to investigate the efficacy of an internet-based self-help~     intervention for dealing with stressful life events.~   "
14345|NCT03379142|"~     1.1 In the last five years, representatives of WellShare International and the University of~     Minnesota have engaged a large community of Muslims of Somali descent in the Twin Cities of~     Minnesota in a community-academic research program to understand smoking and cessation~     behaviors. This followed research by WellShare International which discovered a smoking~     prevalence among Somali men of 44%, which is nearly three times that of the general~     population (14.4%) in Minnesota. More recently, pilot data from ecological momentary~     assessments (EMA) conducted by WellShare International and the University of Minnesota~     Program in Health Disparities Research before and during Ramadan, showed that the majority of~     smokers achieved spontaneous significant reductions in cigarettes smoked per day during~     Ramadan. Guided by the NIH Stage Based Intervention Development Model, this study aims to~     understand the processes underlying smoking reduction and cessation during Ramadan. The~     investigators plan to harness this knowledge and develop a culturally-tailored, faith-based~     smoking cessation intervention (Stage 1). The investigators also plan to assess the~     feasibility of the new culturally-tailored smoking cessation intervention by conducting a~     pilot study (Stage 2).~      The study aims are as follows:~      Aim 1: To develop a faith-based, community-informed innovative smoking cessation intervention~     for use with a Somali immigrant population in Minnesota:~      Aim 2: To assess the feasibility of a faith-based smoking cessation intervention delivered~     via a mobile phone during the Ramadan period:~      This pilot study will test a protocol for use of faith based text messages, as informed by~     the scholarly work of the Imams, Community Advisory Group (CAG) and focus groups conducted in~     Stage 1.~   "
14346|NCT03379129|"~     To evaluate the validity, reliability, and acceptability of employing family-administered~     delirium detection tools in the critically ill. The ultimate goal of this project is to~     improve the care of critically ill patients by creating valid, earlier, and patient and~     family-centered prevention, recognition, and management of delirium.~   "
14347|NCT03379116|"~     To delineate nutritional support in adults patients with severe burns to investigate~     associations between nutritional practice and clinical outcomes.~   "
14348|NCT03379103|"~     Knee arthroplasty is performed with restriction of blood flow by use of the pressure~     tourniquet. Ischemia of skeletal musculature is accompanied by the formation of reactive~     oxygen species and release of vasoactive factors. Inhaled anesthetics were described as~     possible protective factors, termed ischemic preconditioning. The objective of this~     investigation is to observe the effects of preconditioning with inhaled anesthetic on~     bleeding in the postoperative period of knee arthroplasty surgery. The study will be~     prospective and randomized. Patients will be allocated by means of a randomized table in two~     groups: Group Preconditioning (GP) - subarachnoid and general anesthesia with preconditioning~     with 1 minimal alveolar concentration (MAC) for 15 minutes before the installation of the~     ischemia by tourniquet; Group control (GC) - subarachnoid and general anesthesia with~     sevoflurane without preconditioning. Will be evaluated: hemoglobin and hematocrit, platelet~     count and coagulogram, electrolytes and creatinine, lactate and glycemia. Volume of drainage~     will be evaluated until drainage is withdrawn and need for transfusion measuring the number~     of bags of blood concentrate and volume transfused. Pain assessment will be done by means of~     visual analog scale. Morbidity will be recorded up to the 30th postoperative day by chart~     analysis. Patients will be allocated to the study groups by random number table. Data will be~     presented descriptively, frequently, mean and standard deviation, or medians and distribution~     in 25-75% percentiles. The comparison between continuous measurements will be made by means~     of repeated measures intra-group analysis of variance (ANOVA) and Student's t-test for~     evaluation between groups. The need for transfusion will be compared by Fisher's exact test.~     Pain intensity will be compared by Wilcoxon test for non-parametric data. A commercially~     available statistical package - SPSS version 15.0 (SPSS Inc.) will be used. A value of P~     <0.05 will be considered statistically significant.~   "
14349|NCT03379090|"~     Parental constraint of outdoor play may be fueling unhealthy emotional and physical~     development in today's children and adolescents. Time spent outdoors is a key determinant of~     unstructured play and overall physical activity levels, both of which are crucial to optimal~     development in youth. Modern barriers - such as crime, poor social ties among neighbors, and~     unsafe physical environments - constrain parental practices and reduce opportunities for~     outdoor play in children and youth. Low levels of perceived collective efficacy, a measure of~     perceived neighborhood cohesion and the collective capacity to solve neighborhood problems,~     has been proposed as a social environmental factor that constrains outdoor play by parents~     either attempting to avoid potentially dangerous situations or using defensive behavior by~     upgrading security measures. Moreover, incivilities in the neighborhood physical environment~     (e.g. litter, graffiti, blighted property) may influence parents' perceived collective~     efficacy. Consequently, a child's ability to achieve the recommended minimum of 60 minutes of~     daily physical activity may be limited by a complex interaction between neighborhood social~     and physical environmental factors and the extent to which parents respond by constraining~     offspring outdoor play. The central hypothesis of this research is that modifiable factors in~     the neighborhood social and physical environment result in parental constraint of offspring~     outdoor play, which reduces overall physical activity during critical years of development.~     This research will use qualitative methods to generate a comprehensive understanding of how~     and which environmental factors play a crucial role in parental constraint of outdoor play~     and promote low levels of within-neighborhood physical activity. This ancillary study will~     recruit 32 parents/guardians of participants from the parent study, Translational~     Investigation of Growth and Everyday Routines in Kids (TIGER Kids) Study (USDA~     3092-51000-056-04A), to participate in in-depth interviews. My ultimate goal is to use~     knowledge gained from this ancillary study to generate community-based interventions that~     will target neighborhood factors to successfully reduce parental constraints on outdoor play.~   "
14350|NCT03379077|"~     The study has both quantitative and qualitative components.~      The objective of the quantitative study is to:~      Determine if supported implementation of the LTP plus programme improves infant development~     compared to standard implementation of the LTP plus programme.~      The objective of the qualitative study is:~      Process evaluation and finding out about implementation challenges (from the perspective of~     the mothers and the people delivering both the LTP plus and the supported implementation~     intervention).~   "
14351|NCT03379064|"~     Irritable bowel syndrome (IBS) is a highly prevalent functional bowel disorder routinely~     encountered by healthcare providers although it's not life-threatening, this chronic disorder~     has ability to reduce patients' quality of life and imposes a significant economic burden to~     the healthcare system.Despite the high prevalence of IBS and its association with disability~     and adverse effect on health related quality of life we are not aware of any published trial~     of psychological intervention for IBS from Pakistan. We aim to test the feasibility and~     acceptability of culturally adapted Cognitive Behaviour Therapy (CBT) for the management of~     IBS in Karachi, Pakistan compared to treatment as usual.~   "
14352|NCT03379051|"~     This study will be a standard 3+3 design with a lead in of umbralisib (TGR-1202) +~     ublituximab for 12 weeks, i.e. 3 cycles, followed by venetoclax (20 mg - 200 mg) along with~     umbralisib (TGR-1202) and ublituximab for patients with relapsed/refractory CLL.~   "
14353|NCT03379038|"~     This study was conducted to determine the effectiveness of Physical Therapy management in~     relieving constipation among Spastic Cerebral Palsy children. There were two groups, Group A~     received routine Physical Therapy and Group B received maintenance Physical Therapy (aim to~     maintain current level of spasticity, functionality to avoid deterioration of conadition as~     approved by ASRC)~   "
14355|NCT03379012|"~     Purpose~      To determine efficacy and safety of Testosterone in male patients with metastatic renal cell~     carcinoma and fatigue receiving targeted therapy or checkpoint inhibitors.~   "
14359|NCT03378960|"~     The principal aim was to evaluate whether gastric bypass surgery modifies the bioavailability~     of omeprazole 20 mg at one month and six months after surgery.~      Other objectives were:~        -  To compare bioavailability of omeprazole 20 mg between patients undergo gastric bypass~          surgery and patients who avoid it.~        -  To asses other pharmacokinetic parameters, demographic parameters and drug safety.~      Study design It was planned a mixed design which intended to compare the bioavailability in~     patients with gastric bypass (before and after surgery) and control subjects matched by sex~     and body mass index (BMI) post-surgery. This was a single-dose, open-label, crossover~     bioavailability study of omeprazole in surgical group and controls.~   "
14360|NCT03378947|"~     The aim of this study is to characterize and compare clinical, pathological (histology,~     immunophenotype) and molecular features of EBV-related GZL and DLBCL: do they belong to the~     same entity or to two different subtypes of EBV-related lymphoma ?~   "
14361|NCT03378934|"~     The APLABE-PCI is a single-center, randomized, open-label, controlled, dose-escalating,~     parallel-group study, which is designed to assess the anti-platelet effect of berberine in~     approximately 64 patients on aspirin and clopidogrel who are at > 4 but ≤ 12 weeks after~     elective percutaneous coronary intervention for stable coronary artery disease or unstable~     angina.~   "
14362|NCT03378921|"~     The aim of our study is to investigate the efficacy and safety of fecal transplantation in~     the treatment of antibiotic dependent chronic pouchitis. This is a double-blinded randomized~     placebo controlled study. 13 patients receive a fecal transplantation from the healthy tested~     donor and 13 patients in the control group receive their own feces.~   "
14363|NCT03378908|"~     Hypothesis: Patients with Gestational Diabetes Mellitus (GDM) have a high risk to develop~     complications during pregnancy, puerperium and in the newborn. At present there are not~     scientific evidences about the optimal distribution of meals in the medical nutrition therapy~     (MNT) and their relationship with glycemic control.~      Aim: To explore and compare ketonemia and glycemic profile in patients with GDM that follow a~     MNT distributed in 6 or 3 meals. Besides, we want to explore the differences between both~     treatments in glucose dynamics.~      Methods: The study design is a randomized, crossover and multicentric trial. A sample of 10~     patients with GDM will be recruited in the Department of Endocrinology and Nutrition from~     both centres. In a randomized manner patients will follow the conventional treatment (a~     carbohydrate-controlled diet distributed in 6 meals: 3 main meals and 3 snacks) and the~     intervention treatment (a carbohydrate-controlled diet distributed in 3 meals: breakfast,~     lunch and dinner). They will be randomized to begin with one of the two treatments, and after~     two weeks they will be switched to the other treatment. Patients will wear a blinded~     continuous glucose monitoring device (iPro2-TM, Medtronic) during the entire study period.~      Inclusion criteria:~        -  Women with GDM diagnosed in 24-28 weeks.~        -  Age 18-40 years.~        -  Pregnancy age of 28-32 weeks.~        -  Caucasian.~        -  Body mass index ≤ 35 Kg/m2.~      Exclusion criteria:~        -  Unability to understand the dietary recommendations and/or to perform self-management of~          glycemia, ketonuria or ketonemia.~        -  A low adherence to MNT.~        -  Problems with written and/or oral communication.~        -  Presence of comorbidities other than obesity, hypertension and dyslipidemia.~        -  Insulin-need criteria within 3 first days of the beginning of the study (fasting glucose~          ≥90mg/dL, postprandial glucose 1-hour ≥140mg/dL).~      Clinical and sociodemographic variables will be assessed. Dietary records and blood samples~     will be collected. Daily basal ketonuria and ketonemia before each meal will be assessed.~     Glycemic profile will be collected with a blind-sensor during the four weeks of the~     intervention study. Generalized linear model analysis will be performed. Statistical power~     will be 80% and significance level will be set at 0.05. Written informed consent will be~     collected from all participants.~   "
14364|NCT03378895|"~     The state of health in France appears to be good with regard to major indicators such as life~     expectancy at birth.~      However, France is characterized by a high standardized rate of premature mortality (deaths~     occurring before the age of 65) in comparison with other European countries, with~     geographical disparities. Between 2006 and 2010, the standardized rate of premature mortality~     was higher in Auvergne than the national average.~      Chronic diseases such as cardiovascular diseases, cancers and / or metabolic diseases~     (including diabetes and obesity) are the main causes of these premature deaths. These~     diseases have several causes: they depend on the genetic heritage, the way of life and the~     environment. Family history is a known risk factor for these chronic diseases. Eating habits,~     insufficient physical activity or physical inactivity, excessive drinking and smoking which~     promote the occurrence of these chronic diseases are the main risk factors that we can~     modify. Preventive measures are known and are regularly the subject of public health plans~     and awareness campaigns targeting lifestyles modification of the populations. These~     prevention campaigns affect entire population, while the risk factors for chronic diseases~     are different from one to another, this encourages personalization of preventive measures.~     The CEPPPIA pilot study falls within this framework and aims to evaluate the feasibility of~     setting up an individualized prevention program on the modification of health behaviors among~     people aged 35 to 55, who has a moderate risk of developing chronic diseases and residing in~     Auvergne territory.~   "
14365|NCT03378882|"~     Hospitals in the French West Indies (Fort-de-France (Martinique); Basse-Terre and~     Pointe-à-Pitre (Guadeloupe); and French Guiana (Cayenne, Saint-Laurent du Maroni)) have noted~     the emergence of eosinophilic meningitis cases in recent years. This finding is part os~     eosinophilic meningitis cases emergence and meningoencephalitis caused by the parasite~     Angiostrongylus cantonensis on the American continent and in the Greater Antilles.~      In 2013, the investigation of an eosinophilic meningitis case by the Basse-Terre hospital~     team with a positive specific PCR in the CSF (CDC, Atlanta, USA) showed the first case of~     neuromeningeal angiostrongylosis in Guadeloupe. A similar case was diagnosed by serology at~     Pointe-à-Pitre University Hospital a few years earlier without having been published, and~     another serious case diagnosed also at Pointe-à-Pitre University Hospital Center in January~     2017. The team at the Martinique University Hospital Center also reported several cases of~     eosinophilic meningitis with positive serologies for A. cantonensis carried out in~     laboratories outside Martinique (Laboratory of Parasitology, Gonesse, France; Thailand; and~     Tropical Institute and Public Health, Switzerland) in recent years.~      The emergence of this parasitosis is related to the introduction of the intermediate host~     Achatina fulica on the American continent and the geographical evolution of the~     angiostrongylosis cases is intrinsically linked to that of the Achatins. To date, only two~     studies report the environmental presence of Angiostrongylus cantonensis in the Lesser~     Antilles. One proved the presence in rats (23.4%) on the island of Grenada, and the other in~     Guadeloupe, showing that 32.4% of Achatina fulica collected carried the parasite by specific~     PCR. In Martinique, where the number of cases is increasing, and in French Guiana, where~     there is an increase in the number of cases in neighboring countries, especially Brazil, no~     study has been conducted on this parasite.~      In parallel with this finding, several serious digestive tables associated with strong~     hypereosinophilia were reported in Martinique and Guadeloupe in the 90s but also in recent~     years, the last case in December 2016. Etiological diagnoses were established by the~     discovery of Angiostrongylus costaricensis parasite in ileal pathological specimens. However,~     these cases could never be investigated by serology or specific PCR due to lack of diagnostic~     tools available in the French West Indies and Guiana region, and more broadly in metropolitan~     France.~   "
14366|NCT03378869|"~     The investigators retrospectively reviewed the data of all patients who had undergone~     esophagectomy and reconstruction in 2015. Patient characteristics, the surgery performed,~     method of anesthesia, postoperative hospitalization course, and additional surgical~     interventions were reviewed and analyzed.~   "
14478|NCT03377413|"~     The energy and nutrition states are closely associated with CKD patients complications and~     outcomes.To reach the energy balance target, we need the accurate resting energy expenditure~     level of patients. Traditional equations are not applicable to CKD patients,so we aim to~     develop and validate a equation for estimating resting energy expenditure in CKD patients.~   "
14367|NCT03378856|"~     Prospective cohort study of patients receiving standard-care radiotherapy is paramount to a~     better understanding of radiation effects and longterm outcomes.~      The primary objective is to determine the feasibility of establishing infrastructure to~     systematically collect clinical data, patient-reported outcomes, and imaging data from daily~     radiotherapy practice.~      Secondary objectives are to provide a control cohort for comparative effectiveness research~     of investigational interventions through a cmRCT design; compare imaging features with~     clinical outcomes; understand dose-effect relationships; quantify imaging quality metrics.~   "
14368|NCT03378843|"~     This study seeks to test the potential association between spermidine content in diet and~     mortality in humans.~   "
14369|NCT03378830|"~     The study type is a prospective observational cohort study of children undergoing~     adenotonsillectomy (T&A). The study will recruit the annual caseload of children undergoing~     T&A at the Montreal Children's Hospital, QC, Canada; aiming for 200 children. There are no~     interventions.~      The purpose of this study is to determine the severity and duration of postoperative pain~     after T&A and to link the severity of this pain with the severity of sleep disordered~     breathing.~   "
14370|NCT03378817|"~     Kidney transplantation (KT) has emerged as the mainstay of treatment for end-stage kidney~     disease. In an effort to address the widening gap between demand and supply of donor organs,~     there has been an increase in the numbers of marginal or functionally impaired renal~     allografts that had to be accepted for KT over the decades. The use of extended criteria~     donor (ECD) allografts is associated with a higher incidence of primary graft non-function~     (PNF) and/or delayed graft function (DGF). Hypothermic oxygenated machine perfusion (HOPE)~     has been successfully tested in pre-clinical experiments and in a few clinical series of~     donation after cardiac death (DCD) in liver transplantation. The present trial is an~     investigator-initiated pilot study on the effects of HOPE on ECD-allografts in donation after~     brain death (DBD) KT. Fifteen kidney allografts will be submitted to 2 hours of HOPE before~     implantation and are going to be compared to a case matched group transplanted after~     conventional cold storage (CCS).~   "
14371|NCT03378804|"~     The aim of the study is to compare programmed intermittent bolus application and continuous~     epidural infusion with regard to additionally applied patient-controlled volume of local~     anesthesia and quality of analgesia.~   "
14372|NCT03378791|"~     Anemia in pregnancy is defined by the World Health Organization as hemoglobin levels of ≤ 11~     g/dl. Globally, a prevalence rate of 38% was estimated by the World Health Organization for~     pregnant women.Treatment of iron deficiency anemia during pregnancy remains a main public~     health issue. Oral iron salts have been recommended for treatment of iron deficiency anemia~     e.g. ferrous fumarate. Increasing the dose of ferrous fumarate will subsequently increase the~     bioavailability of iron preparation, however it also increases the frequency of~     gastrointestinal tract side effects e.g. nausea, constipation, diarrhea, flatulence, and~     black stained stools. Besides, the increased bioavailable ferrous fumarate may decrease by~     many foods and / or chelating drugs in the gastrointestinal tract which interfere with its~     absorption leading to variability in the hemoglobin correction during the treatment.~      Ferrous bisglycinate is an iron amino acid chelate. It is formed by reaction of ferrous iron~     with two molecules of the amino acid glycine by a covalent bound in a process called~     chelation. Ferrous bisglycinate is claimed to have better patient compliance because of fewer~     gastrointestinal tract side effects. It is also claimed that ferrous bisglycinate improves~     iron absorption, storage and increase hemoglobin level better than the conventionally used~     iron salts.~   "
14373|NCT03378778|"~     Advances in digital dentistry coupled with increased demand for aesthetic restorations have~     led to developments in CAD CAM( Computer Aided Design and Computer Aided~     manufacturing)systems for manufacturing tooth restorations. CAD CAM restorations have the~     added benefit of digital impressions which eliminate the need to take conventional~     impressions, something patients find difficult to tolerate. CAD CAM restorations are now part~     of routine dental care. However there are no clinical studies evaluating these restorations~     on root canal treated teeth~      This study aims to compare the success and survival of root canal treated teeth and/or~     restoration with varying degrees of tooth structure loss restored using CAD CAM restorations.~      Null Hypothesis:- The amount of residual coronal dentin has no effect on the survival of root~     canal treated teeth and/or restoration.~   "
14374|NCT03378765|"~     The objective of this study is to define associations between gut microbiota, SCFAs and~     obesity in populations spanning the epidemiologic transition, and explore mechanisms by which~     these factors may independently and collectively influence the development of obesity. The~     central hypothesis of this study is that the composition of gut microbiota drives SCFA~     production which in turn influences obesity risk at the population-level.~   "
14375|NCT03378752|"~     Atelectasis formation using HFJV during stereotactic solid organ ablations.~      Primary endpoint will be to study the formation of atelectasis during HFJV. Secondary~     endpoint will be to study liver displacement over time. Reference groups will be found in~     previous published articles as referred to above.~      Materials and methods: A radiological protocol has been made for the CT-scanner to take 10 cm~     volume Scans of the lower part of the lung. The scans will have its' lower border tangential~     to the top of the diaphragm. The first scan will be performed in the same session as the~     routine scan of the liver is performed after the patient is anesthetized. These Scans will~     then be repeated every 15 minute during the first 45 minutes. Arterial bloodgas analysis,~     transcutaneous CO2, blood pressure, saturation as well as parameters from the jet ventilator~     and the standard ventilator will be recorded.~   "
14376|NCT03378739|"~     To collect retrospective clinical outcomes related to acute decompensated heart failure~     cardiogenic shock, acute myocardial infarction cardiogenic shock and compare current versus~     historical survival rates.~      To collect Inova Heart and Vascular Institute (IHVI) site specific outcomes before and after~     initiation of the Cardiogenic Shock team on January 1, 2017.~      To collect outcomes related to implementation of mechanical circulatory support versus no~     circulatory intervention and type of intervention (extracorporeal membrane oxygenation (ECMO)~     versus intracorporeal axial-flow (Impella).~      • Assess survival at three time points.~   "
16767|NCT03347474|"~     The main objective of this study is to assess the efficacy of bilateral deep brain~     stimulation (DBS) of the ventral capsule/ventral striatum (VC/VS) as a novel treatment in~     severe methamphetamine addiction. Our hypothesis is that bilateral DBS of the VC/VS will~     significantly reduce the craving for methamphetamine.~   "
14377|NCT03378726|"~     The primary goal of this study is to prevent undernutrition and obesity in peri-urban areas~     of Colombia. This study is designed to evaluate the impact of promoting adequate feeding~     practices and the use of SQ-LNS (Small Quantity Lipid-Based Nutrient Supplements) on the~     nutritional status of infants and young children. The study will be conducted in peri-urban~     areas of Pasto, Colombia in conjunction with Fundación Saldarriaga Concha and the Colombian~     Ministry of Health and Social Protection.~   "
14378|NCT03378713|"~     Trial to determine the absolute and relative efficacy of two follicular preparation regimens~     with transdermal testosterone during the cycle (s) prior to the initiation of COS (controlled~     ovarian stimulation) in patients diagnosed with POR (poor ovarian response) for the increase~     in the number of mature oocytes recovered.~   "
14379|NCT03378700|"~     Introduction A Hong Kong study found that more than half of the chronic kidney disease (CKD)~     patients declined peritoneal dialysis (PD) and preferred receiving palliative care, although~     PD is vital for early preservation of residual kidney functions. Decision-making was found to~     be influenced by feelings of hopelessness, leading to underestimation and the pursuit of a~     successful plan of action. Cumulative evidences revealed that hope is a factor that heightens~     positive expectations in patients, and could lead to consideration of wider alternatives and~     thorough decision making.~      Aim The aim of this study is to examine the effectiveness of a brief hope intervention in~     reducing the decisional conflict and improving the quality of life of CKD patients who have~     to plan for receiving dialysis therapy. If patients' quality of decision-making could be~     improved, timely initiation dialysis and less decisional regret is expected.~      Method This study is a single-blinded randomised controlled trial. On completion of the~     baseline assessment and the screening procedure, eligible participants will be randomly~     assigned in equal number into either the experimental group (education programme plus a brief~     hope intervention) or the control group (education programme) using sets of~     computer-generated random numbers.~      Patients attending the outpatient renal clinic of a regional hospital in HK will be~     approached. Stage 5 CKD patients (GRF equal to or less than 15) who are planned to receive~     dialysis therapy or palliative care will be invited to join the study. Taking into~     consideration of attrition and the health status of the palliative care patients, it was~     appropriate to sign up 36 participants per arm, correlation alpha value 0.6, 0.5 effect size~     with a power of 0.70.~      There are four waves of data collection, which will be done before the commencement of the~     intervention (T1), immediately post-intervention (T2) and one month (T3) and three months~     (T4) after the completion of programme. Primary Outcomes include the assessing the patients'~     decisional conflict, strength of preference, on their choice of treatment modalities between~     peritoneal dialysis and palliative care, and health resources utilization. Secondary outcomes~     measure hope level change and quality of life. Sociodemographic and socioeconomic information~     will be collected. Two open-ended questions will be used to explore the perceived impact and~     benefits of the intervention.~   "
14380|NCT03378687|"~     Phase 1: The first part of study is a multi-center, retrospect study involving 38 hospitals.~     The program is a national epidemiological study on status epilepticus in Chinese children.The~     aims of the epidemiological study include:~        1. to obtain national epidemiological data on the etiology, diagnosis,treatment,evaluation,~          risk factors , outcome and analyze the burden of disease.~        2. to build a Collaborative Network in pediatric status epilepticus research.~        3. to establish a national clinical database of pediatric status epilepticus.~        4. to lay the foundation for the further prospective study.~      Phase 2: The second part of study is a multi-center, prospective study involving 38~     hospitals. The aim of the study is to set up guideline of Children with SE in China.~   "
14381|NCT03378674|"~     Perioperative adequate analgesia reduces neuroendocrine stress response and postoperative~     complications. Because opioids are the most effective parenteral drugs to control pain and~     stress response, in this prospective randomized double-blinded controlled study we supposed~     that higher dose of remifentanil may reduce stress marker variations compared to lower dose~     in patients undergoing laparoscopic cholecystectomy.~   "
14382|NCT03378661|"~     Recent scientific advances have provided further impetus to develop new therapeutic~     approaches for Chagas Disease (CD) using different doses and duration of BZN, as well as~     combinations directed at multiple therapeutic targets to improve treatment response and~     tolerability and reduce the potential for development of resistance.~      This project focuses on the proof-of-concept evaluation of improved treatment regimens of~     BZN, with the assessment of new BZN-sparing regimens in monotherapy and in combination with~     E1224.~   "
14383|NCT03378648|"~     CHF6366 is a novel bifunctional compound displaying both muscarinic receptor antagonist and~     β2-adrenergic receptor agonist properties (MABA), with the potential to deliver optimal~     bronchodilation after inhalation dosing via two validated mechanisms in one molecule.~      The study will consist of three parts:~      Part 1 will consit of two cohorts of healthy male subjects to assess the safety, tolerability~     and pharmacokinetics of Single Ascending Dose (SAD) of CHF 6366~      Part 2 will consist of four cohorts of asthmatic subjects to assess the saftey, tolerability~     and pharmacokinetics of Multiple Ascending Dose (MAD) of CHF6366~      Part 3 will consist of one cohort of COPD patients to asess safety, tolerability of a single~     dose of CHF6366 in an active and placebo controlled design~   "
14384|NCT03378635|"~     The objective of the trial is to demonstrate superiority of dasiglucagon compared to placebo~     following a single subcutaneous dose administered to subjects with type 1 diabetes mellitus~     with insulin-induced hypoglycemia. Additionaly to compare the glycemic response observed~     after administration dasiglucagon with that of GlucaGen®.~   "
14385|NCT03378622|"~     1. PRIMARY OBJECTIVE: To assess the effect of absorbable anchor compared to suturing for~          mesh attachment to vagina in robotic assisted sacrocolpopexy on the length of surgery~          for this portion of the procedure.~        2. SECONDARY OBJECTIVES:~           i. To assess intraoperative and ii. postoperative complication rates, iii.~          Intraoperative 10 cm visual analog scale (VAS), to subjectively assess surgeon~          satisfaction with the technique iv. post-operative Pelvic Organ Prolapse Quantification~          (POPQ) evaluation for anatomic failure and v. a VAS of the vaginal walls overall~          appearance~   "
14386|NCT03378609|"~     Vocal fatigue has been described as a common complaint in patients with voice disorders,~     however to date there is no standardized questionnaire in german language to assess specific~     symptoms. Main aim of this study is to assess the validity of the first german version of the~     Vocal Fatigue Index (VFI), and english questionnaire developed for voice patients to assess~     vocal fatigue.~      In this study patients with voice disorders will receive the patient based questionnaires~     Vocal Fatigue Index (VFI), Voice Handicap Index 9 international (VHI 9i) and Vocal Tract~     Discomfort Scale (VTD), the study information and consent letter together with the standard~     invitation letter to a voice assessment at the Department for Phoniatrics and Speech~     Pathology University Hospital Zurich. Data of 93 consecutive volunteering patients will be~     collected. Furthermore a retest using the VFI will be conducted after 1 week with 10~     volunteers. Thereafter construct validity of the VFI as compared to the established voice~     symptom questionnaires VHI 9i and VTD will be investigated. Further test-retest reliability~     will be determined.~   "
14387|NCT03378596|"~     Post-exercise hypotension (PEH) is a established phenomenon as one of the non-pharmacological~     ways of reducing blood pressure, producing important impacts, particularly in hypertensive~     individuals. However, the factors involved in the magnitude and duration of this effect are~     relatively little studied. Thus, the bioavailability of vasodilatation mediators may maximize~     the duration and magnitude of PEH. In this sense, the objective of the present project will~     be to verify the impact of L-citrulline associated with L-arginine supplementation on the~     acute blood pressure response after an aerobic exercise session. Approximately 80 adults (40~     normotensive and 40 hypertensive) will be selected. The sample will be submitted to~     measurements of body mass, height and resting blood pressure. After the minimum interval of~     48 h, subjects will be randomly submitted to four experimental situations~     (exercise/L-citrulline, exercise/L-arginine, exercise/placebo, exercise/L-citrulline +~     L-arginine). The exercise sessions (40 min in treadmill at 60% of FCres) will be performed~     with a minimum interval of 48 h. After each session, the blood pressure of the sample will be~     recorded during 24 hours. For data analysis, blood pressure values will be plotted in average~     of the wakefulness and average of the sleep periods and average of the 24 hours. The~     comparisons will be made through the ANOVA (repeated measures), following the recommended~     assumptions. It is hoped that the results of this project will collaborate to the knowledge~     regarding non-pharmacological models aimed at the prevention and treatment of hypertension in~     normotensive and hypertensive patients.~   "
14388|NCT03378583|"~     Evaluation of a new method to prevent gastric insufflation~   "
14389|NCT03378570|"~     The purpose of this study is to examine the effects of different treatment locations using~     repetitive transcranial magnetic stimulation (rTMS) to treat major depressive disorder.~   "
14390|NCT03378557|"~     This registry supports international data collection and research on PPFx treatments after~     hip and knee arthroplasty.~      A registry such as this ultimately aims to provide far-reaching benefits to society including~     reduced morbidity and mortality, improved patient safety, improved quality of care and~     medical decision-making, reduced medical spending, and advances in orthopaedic science.~   "
14391|NCT03378544|"~     Evidence from Low and Middle Income Countries has demonstrated the effectiveness of various~     psychosocial approaches for depression. However, there are no mental health specialists to~     deliver these interventions especially in rural African settings. This study aims at testing~     the effectiveness of mental health Global Action Programme (mhGAP-IG) psychosocial~     interventions among Traditional Birth Attendants (TBAs) for pregnant mothers. The outcomes of~     this intervention will result into depression reduction in the mothers that will lead to~     better care during pregnancy and for their infants, allowing for long-term impact on their~     physical and the psychological wellbeing and that of their children.~   "
14392|NCT03378531|"~     The purpose of this study is to investigate the long-term safety, tolerability,~     immunogenicity, pharmacokinetics and pharmacodynamics of intravenous AEB1102 in patients who~     complete Study CAEB1102-101A.~   "
14393|NCT03378518|"~     This study aimed to retrospectively examine patients evaluated by the Code Blue team on a~     Code Blue call in our hospital between 2016-2017.~      Primary outcome: an examination of the survival rates and demographic data of the patients~     evaluated as an emergency by a Code Blue call in the period 2016-2017.~      Secondary outcome: to determine the rates of false Code Blue calls, the clinics giving Code~     Blue calls and the relationship between the times of Code Blue calls and mortality.~   "
14394|NCT03378505|"~     This study will examine the impact of a mobile app (JOOL) focused on promoting purposeful~     living on student health behaviors, academic performance, self-regulation, well-being,~     resiliency, and self-efficacy.~   "
14395|NCT03378492|"~     This randomized controlled trial will evaluate the use of ultrasound as an aid for epidural~     placement in residents performing all epidural techniques under direct staff anesthesiologist~     supervision.~   "
14396|NCT03378479|"~     The objective of this study is to deliver proof of concept that antifungal prophylaxis can~     reduce the incidence of Influenza Associated Aspergillosis (IAA) in ICU (intensive care unit)~     patients with severe influenza.~      The investigators will perform an interventional non-blinded randomized controlled~     multicentric proof-of-concept study in patients with severe influenza admitted to the ICU.~     Patients will be randomized to the posaconazole prophylaxis group or to the SOC (standard of~     care) group. Oseltamivir will be started at the discretion of the investigator. Patients in~     the posaconazole group will receive posaconazole prophylaxis for 7 days.~      addendum: pharmacokinetics of posaconazole as prophylaxis for invasive fungal disease on ICU~   "
14397|NCT03378466|"~     This study is a pragmatic open-label international randomized trial comparing therapeutic~     dose intravenous unfractionated heparin (UFH) to standard care venous thromboprophylaxis in~     patients diagnosed with septic shock.~   "
14398|NCT03378453|"~     Links between orexin and amyloid processes have been underlined recently. During the~     Alzheimer's process an upregulation of the orexin mechanism has been observed. The~     pathophysiological mechanism of narcolepsy type 1 is linked to orexin deficiency. Thus, the~     investigators hypothesized that patients with narcolepsy may be protected from amyloid brain~     lesions, hallmarks of the Alzheimer's process. To test this hypothesis, the investigators~     analyzed the brain amyloid load measured by PET-scan amyloid brain imaging in patients with~     narcolepsy type 1 compared to controls without cognitive deficits.~   "
14413|NCT03378258|"~     A fever and a non-blanching rash is a relatively common reason for a child to attend an~     emergency department. A fever and a non-blanching rash can be an early sign of a~     life-threatening infection known as meningococcal disease. The aim of the PIC study is to~     determine how best to diagnose early meningococcal disease in children.~      In particular the investigators are interested in researching how quick bedside tests can be~     used to do this.~   "
14414|NCT03378245|"~     The purpose of this study is to investigate the use of telemedicine-based intervention at~     urban and rural skilled nursing facilities to recommend multidisciplinary dementia care to~     residents with dementia who are at risk for unnecessary hospitalization due behavioral or~     neuropsychiatric symptoms and/or complications as well as caregivers and facility staff. The~     multidisciplinary team is comprised of trained behavioral neurologists, social workers,~     advanced practice providers, primary medical team and nurse coordinators.~   "
49168|NCT02923349|"~     The purpose of this study is to determine the safety and tolerability and assess preliminary~     efficacy of INCAGN01949 in subjects with advanced or metastatic solid tumors.~   "
14399|NCT03378440|"~     The purpose of this study is to explore the association between the psychosocial variables:~     quality of life, fear of movement, coping skills, self-efficacy and physical activity, with~     chronic pain and disability after a total knee arthroplasty. The prevalence of TKA has~     increased dramatically during the last two decades, its popularity can be attributed to its~     evident success regarding pain improvement, deformity correction and disability reduction in~     knee osteoarthritis subjects. However, only a third of the patients report no functional~     problems after surgery, the 20% of them are unsatisfied with its functional skills and around~     a 20% are experiencing pain, high disability degrees and a significant quality of life~     reduction. This results cannot be fully explained by mechanical processes, surgical~     procedures or surgery variations, but seems to be related to other psychological aspects.~     Chronic pain subjects often develop maladaptive thoughts and behaviours (i.e. pain~     catastrophism, kinesiophobia, activity avoidance) which contribute to make the subject suffer~     physically as well as emotionally, and affect on the intensity and persistency of pain.~      This study is a single centre, prospective observational study of subjects undergoing primary~     total knee arthroplasty (TKA). The study is designed and aimed to examine the relationship~     between pre-operative psychosocial factors and the development of post-operative persistent~     pain and disability.~   "
14400|NCT03378427|"~     Pilot study the aim of which is to obtain reliable data on the tolerance, compliance and~     efficacy of Tedizolid used as prolonged (≥ 6 weeks) monotherapy or in combination therapy for~     the treatment of patients with orthopedic device infections due to Gram positive cocci.~   "
14401|NCT03378414|"~     The purpose of this study is verify the safety and efficacy of Human Umbilical Cord~     Mesenchymal Stem Cells (UC-MSC) therapy for patients with Spinocerebellar Ataxia, and in~     addition, explore the possible mechanisms of UC-MSC therapy in Spinocerebellar Ataxia.~   "
14402|NCT03378401|"~     The objective of the study is to demonstrate the superiority of 0.1% octenidine mouthwash~     (Octenidin Mundspüllösung, OML) to placebo (PLAC) in the inhibition of plaque formation. The~     study will consist of a 14-day screening period and a 5-day treatment period.~   "
14403|NCT03378388|"~     The purpose of this study is to describe in real life the effectiveness of treatment with~     vedolizumab.~   "
14404|NCT03378375|"~     Introduction: Resting energy expenditure (REE) formulas for healthy people (HP) are used to~     calculate REE (cREE) in amyotrophic lateral sclerosis (ALS) patients. In ALS an increase of~     measured REE (mREE) in indirect calometry (IC) compared to cREE is found in 50-60%. The aims~     were (i) to assess accuracy of cREE assessed using eleven formulas as compared to mREE and~     (ii) to create if needed a specific cREE formula for ALS patients.~      Method: ALS patients followed in the ALS expert center of Limoges between 1996 and 2014 and~     with a nutritional evaluation were included. mREE assessed with IC and cREE calculated with~     eleven predictive formulas (Harris Benedict (HB) 1919, HB 1984, WSchofield, De Lorenzo,~     Johnstone, Mifflin, WHO/FAO, Owen, Fleisch, Wang and Rosenbaum) were collected at time of~     diagnosis. Fat free mass (FFM) and fat mass (FM) were measured with impedancemetry. A Bland~     and Altman analysis was carried out. The percentage of accurate prediction ± 10%of mREE, and~     intraclass correlation coefficients (ICC) were calculated. Using a derivation sample, a new~     REE formula was created using multiple linear regression according to sex, age, FFM and FM.~     Accuracy of this formula was assessed in a validation sample.~   "
14405|NCT03378362|"~     Prospective study on the effect of partial wrist denervation (ie combined anterior and~     posterior interosseous neurectomy) on pain relief on functional outcome in patient with wrist~     osteoarthritis. The impact of psychological factors on postoperative outcome will be studied.~   "
14406|NCT03378349|"~     The aim is to evaluate if internet- delivered cognitive behavior therapy (CBT), based on~     exposure principles and behavioral activation, improves QoL and symptom burden in patients~     with symptomatic atrial fibrillation (AF) compared to treatment as usual. The study will~     include 120 patients with symptomatic AF despite optimal medical treatment in accordance with~     current guidelines.~   "
14407|NCT03378336|"~     Psoriatic arthritis (PsA) is an inflammatory arthritis with substantial variation in clinical~     features. We propose a multicenter collaborative approach to better understand the phenotypes~     and current management of PsA in the United States.The central goal of this proposal is to~     obtain the data necessary to design a pragmatic trial in PsA.~   "
14408|NCT03378323|"~     Patients will be randomized to one of two groups:~        1. Multiple injection group: Axillary brachial plexus block with multiple injections, with~          the arm abducted, performed with the aid of ultrasound;~        2. Single injection group: Axillary brachial plexus block with a single injection, with the~          arm placed behind the head and the elbow flexed, performed with the aid of ultrasound~   "
14409|NCT03378310|"~     This is a Phase 1, open-label, randomized study in healthy participants to evaluate the~     absorption of a BMS-986205 tablet into the bloodstream compared to a reference tablet.~     Eligible participants will be randomly assigned to 1 of 2 treatment sequences and will~     receive a single, oral dose of BMS-986205 twice over 22 days. Participants must remain at the~     clinical facility for the duration of the study.~   "
14410|NCT03378297|"~     The study will be conducted in women with advanced (stage IIIa-IV) ovarian cancer of the~     histologic subtype high grade serous carcinoma (HGSOC) who are going through a diagnostic~     laparoscopy. They will recieve treatment with a study agent for 10-14 days before surgery.~     They will be allocated to different study groups according to the diagnostic evaluation~     performed as standard of care at the department. The study is non-randomized and unblinded.~      The primary investigational agents are:~        1. Metformin tablets, 850 mg x 2 orally.~        2. Acetylsalicylic acid tablets, 160 mg x1 orally~        3. Olaparib capsules, 300 mg x 2 orally~        4. Letrozol tablets, 2.5 mg x 1 orally~   "
14411|NCT03378284|"~     A randomized, open-label, active-controlled, multiple dose phase 1 clinical trial to evaluate~     safety, tolerability, and pharmacodynamics of tegoprazan after oral administration in healthy~     male volunteers~   "
14412|NCT03378271|"~     The study aims to evaluate the accuracy of two commercial glucose monitoring systems in~     patients with type 1 or type 2 diabetes and renal impairment, including patients with or~     without dialysis. Patients treatment experience will even be evaluated.~   "
14428|NCT03378063|"~     Very preterm infants are at high risk to develop to bronchopulmonary dysplasia (BPD) for the~     lack of effective measures to prevent or ameliorate this common and serious disorder. BPD~     remains a major cause of mortality and lifelong morbidity in preterm infants~   "
14415|NCT03378232|"~     Omega 3 fatty acids have been shown to provide a number of cardiometabolic benefits in both~     healthy and at risk populations. Specifically, the daily consumption of fish oil supplements~     has been reported to reduce blood triglyceride levels, and influence glucose homeostasis and~     whole-body inflammation. Furthermore, a number of cardiovascular effects (i.e. reduced blood~     pressure, reduced coagulation) have been found to result from omega-3 consumption, as well as~     influencing energy expenditure (i.e. resting metabolic rate). The goal of this study is to~     examine the cardiometabolic and cardiovascular effects that result from long-term consumption~     of omega-3 fatty acids.~   "
14416|NCT03378219|"~     Primary Objective:~      To evaluate the relative risk of major structural birth defects, specifically a pattern of~     anomalies, in sarilumab-exposed pregnancies compared to disease-matched unexposed~     pregnancies.~      Secondary Objective:~      To evaluate the risk for sarilumab-exposure relative to the group of healthy pregnant women,~     and the effect of exposure on other adverse pregnancy and infants outcomes.~   "
14417|NCT03378206|"~     To assess the therapeutic effect of hinged 8-figure plate by comparing with the traditional~     8-figure plate through a randomized controlled clinical trial by assessing the differences~     between preoperative and postoperative data.~      The hypothesis is that the hinged 8 plate provides low complications that this treatment is~     as good as the traditional one.~   "
14418|NCT03378193|"~     Head and neck (HN) cancer is the sixth most common malignancy worldwide, with around 800,000~     new cases and 320,000 deaths in 2015. These malignancies encompass cancers of the oral~     cavity, oropharynx, hypopharynx and larynx and concerned squamous cell carcinomas (SCC) 90%~     of the time.~      Despite aggressive treatment strategies, the five-year survival rate has only marginally~     improved in the past decade especially because of a high rate (up to 40%) of loco-regional~     recurrence. Moreover, two-third of local relapse and lymph node metastases occur in the first~     2 years after treatment. Hence, predicting tumor response to therapy remains a real challenge~     in head and neck cancers.~      Usual prognostic factors include the tumor size, the lymph node involvement, the presence of~     distant metastasis, the anatomic subsite, and the human papilloma virus (HPV 16, 18)~     infection status. However, pre-treatment selection of patients with poor prognosis or who~     require intensified therapy remains difficult despite their careful evaluation.~      HNSCC also present a high biologic heterogeneity with hypoxic area, necrotic regions, zones~     of high cellular proliferation and intra-tumoral angiogenic heterogeneity. A better~     characterization of tumor heterogeneity could help classify patients in different risk~     subgroups in order to improve their therapeutic management.~      Pre-therapeutic 18F-fluorodeoxyglucose positron-emission tomography (FDG PET/CT) is~     recommended by guidelines to assess remote extension of locally advanced HNSCC and/or to look~     for synchronous cancer. Its prognostic significance has already been suggested and a~     selection of patients at risk of recurrence appears possible using different quantitative~     parameters. Indeed, static (SUV = Standardized Uptake Value), volumetric (MTV = Metabolic~     Tumor Volume, TLG = Total Lesion Glycolysis) and kinetic (RI = Retention Index) parameters~     were demonstrated to be independent prognostic factors in several studies.~      Texture analysis is currently highly studied in order to characterize tumor heterogeneity,~     and consists in extracting texture indices from different imaging modalities such as FDG~     PET/CT. Calculating texture indices relies on choosing a contouring method to delineate a~     tumor volume of interest and selecting several parameters such as the resampling method,~     matrix definitions and indices formula. Several studies conducted on small series of patients~     with HNSCC have showed promising results to predict survival, analyzing various cancer~     anatomic subsites, tumor segmentation methods and texture indices.~      The objective of this study is to assess the prognostic value of texture indices in a large~     cohort of patients with HSNCC, including any anatomic subtype and staging.~   "
14419|NCT03378180|"~     Anatomical variations of right main bronchus have been discouraged anesthesiologists' use of~     right-sided double lumen tubes to facilitate one-lung anesthesia. However, there are absolute~     indications of right-sided DLTs surgically, such as left pneumonectomy or in cases with left~     main endobronchial lesions.~      With recent advances of 3-dimensional spiral CT reconstruction technique, the investigators~     conducted this retrospective study to measure accurate length of right and left main bronchus~     and the angle between the center of the right main bronchus and right upper lobe orifice in~     axial image to help choosing and further manufacturing right-sided double-lumen tubes.~   "
14420|NCT03378167|"~     The objective of this pilot study is to assess the feasibility of a treatment protocol of FMT~     for the treatment of active pediatric CD. Specifically, we will test the hypothesis that a~     protocol of combination fecal microbiota colonoscopic infusion and oral microbiota capsules~     (OMC), using live fecal material from anonymous unrelated donors, can improve the disease~     activity of pediatric CD patients.~   "
14421|NCT03378154|"~     The primary objective of this study is to find out whether the intubation success rates of~     Kingvision video laryngoscope is better than that of the conventional laryngoscopes in~     children < 1 year of age?~   "
14422|NCT03378141|"~     Maternal nutrition has been a long-standing concern of health authorities globally and in~     India. Despite the availability of proven, affordable interventions, and progressive policies~     and program platforms such as Maternal, Newborn and Child Health (MNCH) services, a~     streamlined package of proven maternal nutrition services is not reaching the majority of~     women during pregnancy.~      Alive & Thrive India aims to test the feasibility of integrating a package of maternal~     nutrition interventions in routine Reproductive, Maternal, Newborn and Child Health (RMNCH)~     services.These include provision of IFA and calcium supplements, interpersonal counseling on~     diet during pregnancy and consumption of IFA and calcium, community mobilization, and~     adequate weight-gain monitoring during pregnancy.~      This proposed evaluation aims to assess the feasibility of integrating maternal nutrition~     interventions into an existing RMNCH services in India, using a cluster-randomized evaluation~     design~   "
14423|NCT03378128|"~     The purpose of this study is to see if patients undergoing a laparoscopic surgery for removal~     of ovarian, fallopian tube, or primary peritoneal cancer following neoadjuvant chemotherapy~     (neoadjuvant- chemotherapy given before surgery) is feasible, safe, and provides similar~     outcomes as compared to undergoing a large abdominal incision. Minimally invasive, or~     laparoscopic, surgery is a type of surgery where only small incisions are made on the abdomen~     and surgical instruments are placed through these incisions to perform the surgery. This type~     of surgery has been shown to improve outcomes in many types of surgery, including in~     gynecologic cancer surgery. Specifically, researchers know that patients who have minimally~     invasive surgery have less pain after surgery, can go home quicker from the hospital, healing~     time is more rapid, and potentially this can translate into returning to chemotherapy sooner.~     Specifically, in ovarian, fallopian tube, and primary peritoneal cancer, minimally invasive~     surgery has not been used as much because these cancers can have tumors all throughout the~     inside of the abdomen (i.e. wide tumor burden) and located in areas that are sometimes not~     easily reachable with laparoscopic instruments. However, the reason patients receive~     neoadjuvant chemotherapy is to shrink the tumor/s to make the surgery less extensive and the~     recovery easier. It is unknown if minimally invasive surgery can be used in this setting and~     by studying this, the study team will be able to determine if patient outcomes are improved~     by implementing (using) this surgical technique.~   "
14424|NCT03378115|"~     The purpose of this study is to determine the magnitude of changes in energy expenditure and~     respiratory quotient (RQ) during sitting and standing in Asian men.~   "
14425|NCT03378102|"~     The purpose of this study is to determine if it is possible to treat an infection with a~     cell-based immunotherapy (therapy that uses the patient's own immune system to treat the~     infection). This treatment is called adoptive T cell therapy. Another purpose is to learn~     about the side effects and toxicities of adoptive T cell therapy.~      Adoptive T cell therapy is an investigational (experimental) therapy that works by using the~     blood of a donor that has immunity against the virus. The donor cells are collected and then~     the cells, called T cells, that are capable of defending against the virus are selected out.~     These selected T cells are then infused back into the patient, to try to give the immune~     system the ability to fight the infection. Adoptive T cell therapy is experimental because it~     is not approved by the Food and Drug Administration (FDA).~   "
14426|NCT03378089|"~     The purpose of this randomized, controlled study is to determine the effects of~     pre-transplant music therapy on mood, distress, and physical functioning variables in~     patients undergoing Hematopoietic Stem Cell Transplant (HSCT).~   "
14427|NCT03378076|"~     This is a randomized, open-label, parallel group study to compare systemic exposure of~     triamcinolone acetonide following administration into both knees of either FX006 or TAcs.~   "
14430|NCT03378037|"~     Traumatic brain injury (TBI) is a severely disabling injury which affects 150-200 people per~     million annually. Increasing evidence suggests that TBI may be a major risk of dementia,~     Alzheimer's disease (AD) in particular. Postmortem evidence has shown that beta-amyloid (Aβ)~     deposits, one of the most validated pathological biomarkers of AD, are present in the brains~     of severe TBI patients. Although the underlying mechanisms remain unclear, the axonal injury~     may play a role. Imaging investigations have revealed Aβ density maps of TBI patients~     overlapped with those of AD patients, and increased Aβdensity not only associated with~     prolonged TBI duration but also associated with decreased white matter integrity. Hence, the~     increasing accumulation in Aβ due to TBI may contribute to the initiation of the pathological~     alterations seen in AD. Treatment of TBI may not only be of benefit for the injury itself but~     also act to block the pathological changes in AD.~      As a part of the clinical arm of the project, in this subproject investigators will conduct a~     single-blind, block-randomized clinical trial to investigate the efficacy of acupuncture in~     TBI. More specifically, investigators hypothesize that acupuncture intervention will elicit~     neuroprotective processes and thereby reduce axonal damage in TBI, manifested as (1)~     decreased plasma levels of Aβ peptide, tau, and glial fibrillary acidic protein (GFAP) and~     (2) increased white matter integrity after acupuncture. Ninety-six participants will be~     randomly allocated to the acupuncture intervention (verum acupuncture) or control group (sham~     acupuncture) in a 1:1 ratio. All participants will receive 20 minutes of acupuncture~     treatment twice a week for 2 weeks. A set of commonly used acupoints for TBI treatment will~     be manually stimulated every 10 minutes. The multi-modality magnetic resonance imaging (T1,~     T2, and diffusion tensor imaging) and blood sample will be taken before and after the~     acupuncture session to measure the white matter integrity in brain and plasma levels of Aβ~     peptide, tau, and GFAP, respectively. After integrate these data with other subprojects, we~     can provide synergic and integrative mechanisms of the effects of acupuncture on the risk of~     AD after TBI.~   "
14431|NCT03378024|"~     By utilizing Near infrared spectroscopy (NIRS), the local blood flow, tissue oxygenation~     (StO2), and recovery time of ischemic leg; can be determined. It is reasonable to standardize~     an easy, simple and safe Active Pedal Plantarflexion (APP) exercise test working load which~     can achieve the lowest StO2 and other parameters in ischemic leg through observation of NIRS.~     After standardized of an effective APP test, a determination of a new cutoff value of resting~     ABI in diagnosing PAD can probably be searched. Analysing the correlation of baPWV with ABI,~     atherosclerosis risk factors and parameters with atherosclerosis outcome. Observation the~     Sequential changes of baPWV, ABI and microalbuminuria after managing the atherosclerosis~     risks, and analyze their influence on the outcome of PAD, coronary artery disease(CAD) and~     cerebral vascular disease(CVA) outcomes.~   "
14432|NCT03378011|"~     evaluate the effect of UVA1 phototherapy in the treatment of acral vitiligo.~   "
14433|NCT03377998|"~     Expression of Erythroid differentiation regulator 1 (Erdr1) cytokine in vitiligo~   "
14434|NCT03377985|"~     The current study focused on ultrasound guided brachial plexus block (BPB) which plays an~     important role in patients with hand trauma either in pain control or for surgical~     intervention. The brachial plexus can be blocked by several techniques but the most commonly~     used are the supraclavicular (SCB) and axillary (AXB) blocks. Aim of this study is to compare~     between the two techniques as regard performance time, needling time, anesthesia related~     time, block related complications, number of needle pass, and block related pain. 80 patients~     were allocated randomly into two equal groups, under ultrasound guidance the SCB and AXB were~     done for the two groups respectively. The needling time, performance time, anesthesia related~     time, onset time, number of 1st needle pass in each group and block related complications~     were noted.~   "
14435|NCT03377972|"~     Endoscopic Submucosal Dissection (ESD) is currently the main method of treatment of early~     esophageal cancer and precancerous lesions. Therefore, the investigators are looking forward~     to conduct a cohort study on early esophageal cancer patients undergoing endoscopic treatment~     collected from Zhongshan Hospital, Fudan University, comparing the WHO standard with Japanese~     standard of endoscopic therapy diagnosis. In addition，the investigators will collect~     patients' detailed informations and analyze the risk factors for metastasis and recurrence of~     early esophageal cancer.~   "
14436|NCT03377959|"~     A high degree of turnout is desired by many dancers, because enables an efficient weight~     transfer; provides an excellent extension and control; and reduces the risk of injury when~     used properly. The dancer's body conditioning is worked and acquired through various types of~     training, among which stands out the Pilates Method. Thus, the aim of the study is to~     determine the effect of a training program of Pilates Method in the range of ballerinas'~     turnout. The study will be conducted with young dancers, between 10 and 14 years, who~     practice classical dance twice a week. They will be randomly divided into two groups:~     intervention and control, but only the intervention group will do Pilates classes. To verify~     the extent of the turnout, tests will be applied in both groups, before the start of Pilates~     classes (pre-test) and after 24 sessions (post-test). In the evaluation protocol will be~     collected kinematic data, while performing the movements of demi plié and elevé.~     Anthropometric variables of height and body mass will be obtained; and also the extent of the~     passive and active turnout in dancers.~   "
14437|NCT03377946|"~     This study is aimed at verifying the effects of probiotics (KAWAI:dead S.thermophilus) on~     glucos management among T2DM and pre-diabetes Chinese adult. Additionally, the investigators~     intend to verify the effects of probiotics on modifying the structure and function of gut~     microbiome.~   "
14438|NCT03377933|"~     This study assesses the efficacy and safety of treatment with two-week probiotics followed by~     a 10-day tetracycline- and furazolidone-containing quadruple regimen as rescue treatment for~     H. pylori infection. Eradication was evaluated using the 13C-urea breath test at 4 weeks~     after the end of therapy, and side effects were recorded. Besides study gene-level changes in~     the gastric microbiota following use of probiotics.~   "
14439|NCT03377920|"~     The main aim is to study correlations between Peak inspiratory flow measured during a~     spirometry (PIFspiro) and Peak inspiratory flow measured over a pre-set resistance~     (PIFresist) in COPD patients and severe asthma patients. PIFresist will be measured using 5~     different resistances, representing all DPI's relevant for the treatment of obstructive lung~     diseases. If this shows a distinct relationship between PIFspiro and PIFresist, PIFspiro~     cut-off points will be sought in an attempt to predict which patients are likely to be able~     to produce optimal flows for DPI use. If successful, this will make the actual measurement of~     PIFresist redundant in clinical practice. Also the relationship between PIFresist and device~     internal resistance in addition to PIFspiro (which corresponds to a very low resistance) will~     be examined.~   "
14440|NCT03377907|"~     fractures of upper limb induce much pain . A lot of modalities are available to alleviate~     pain. fracture hematoma block, and intravenous regional anesthesia seem to be cost effective~     and attractive options~   "
14441|NCT03377894|"~     comparison between blunt versus sharp expansion of uterine incision at lower segment cesarean~     section in primigravida as regards the intra-operative blood loss & postoperative pain~   "
14443|NCT03377868|"~     Amyotrophic Lateral Sclerosis (ALS) is an adult-onset, devastating, neurodegenerative disease~     characterized by the loss of cortical, brain stem, and spinal motor neurons. Visual evoked~     potentials studies in patients with ALS suggest visual pathway involvement. Optic coherence~     tomography (OCT) is a non-invasive cross-sectional imaging modality measuring the optical~     reflections in biological tissues. The main objective of this observational cohort study is~     to explore the correlation between changes on OCT retinal parameters and and clinical~     disability as measured by the ALS Functional Rating Scale (ALS-FRS-r) in patients with ALS at~     baseline, 3 and 6 months. A secondary objective is to explore the correlation between changes~     in retinal OCT parameters and pulmonary function tests (FVC and FEV1) in this cohort of~     patients with ALS. A parallel cohort of healthy age and sex matched subjects will participate~     as controls to obtain reference values of their retinal layers' thickness at baseline, 3 and~     6 months.~   "
14444|NCT03377855|"~     Risk of long-term opioid dependence increases with initial opioid dose/duration, but despite~     recent CDC (Centers for Disease Control and Prevention)-endorsed minimum doses for initial~     opioid prescription, primary care providers are likely to overprescribe. In this quality~     improvement project, primary care departments at Weill Cornell and the Institute for Family~     Health (NYC-based FQHC) will implement an unobtrusive nudge in their electronic prescribing~     software to promote the CDC (Centers for Disease Control and Prevention)-endorsed low doses~     for all opioids. In the evaluation, we will employ a quasi-experimental design with rigorous~     interrupted time series analysis methods to assess the effect of the nudge on prescribing~     rates. The analysis will be performed at the provider level, with deidentified physician data~     and a limited data set (fully deidentified except for date of prescription) of patient-level~     data.~   "
14445|NCT03377842|"~     Apatinib has been proved to be effective and safe among patients in advanced colorectal~     cancer in several trials. the investigators aimed to evaluate its efficacy and safety as the~     neoadjuvant therapy in real world practice, and to explore factors associated with efficacy.~   "
14446|NCT03377829|"~     This is a multicenter prospective controlled trial of percutaneous laser ablation(PLA) versus~     conventional surgery for the treatment of papillary thyroid microcarcinoma (PTMC).~   "
14447|NCT03377816|"~     The purpose of this study is to examine two mechanistic changes: emotion processing~     (awareness, expression and acceptance) and cholinergic anti-inflammatory processes (HRV and~     cytokine expression) through which an Art Therapy (AT) intervention reduces depression, pain~     and fatigue.~   "
14448|NCT03377803|"~     This study is a Phase 3, randomized, double-blind, placebo-controlled, pivotal study to~     evaluate the safety and efficacy of VP-102 topical film-forming solution in subjects with~     Molluscum Contagiosum. VP-102 will be applied once every 21 days for up to 4 applications, to~     treatable molluscum contagiosum (molluscum) lesions on subjects 2 years and older. Efficacy~     will be assessed as the proportion of subjects achieving complete clearance of all treatable~     molluscum lesions (baseline and new) on the Day 84 visit.~   "
14449|NCT03377790|"~     This study is a Phase 3, randomized, double-blind, placebo-controlled, pivotal study to~     evaluate the safety and efficacy of VP-102 topical film-forming solution in subjects with~     Molluscum Contagiosum. VP-102 will be applied once every 21 days for up to 4 applications, to~     treatable molluscum contagiosum (molluscum) lesions on subjects 2 years and older. Efficacy~     will be assessed as the proportion of subjects achieving complete clearance of all treatable~     molluscum lesions (baseline and new) on the Day 84 visit.~   "
14450|NCT03377777|"~     Serum and fecal samples were collected from infants at either 6-7 m of age or 12-13 m of age.~     Serum and feces were analyzed locally for hemoglobin status or evidence of parasites, and~     standard of care was provided. Excess serum was transported to UC Davis for metabolomics~     analysis and the University of Hohenheim for iron status assessment and measurement of~     inflammatory markers. Fecal samples were transported to UC Davis for measurement of the~     microbiome structure and function.~   "
14451|NCT03377764|"~     Anesthesia trainees can perform spinal anesthesia in patients who have poorly-palpable~     surface landmarks with fewer needle passes using an ultrasound-guided technique compared to~     the conventional surface landmark-guided technique.~   "
14452|NCT03377751|"~     This study is designed to investigate whether pulmonary vein isolation(PVI) plus stepwise~     additional ablation approach based on the degree of low voltage area versus PVI only can~     improve procedure outcome in persistent atrial fibrillation(AF) patients.~   "
14453|NCT03377738|"~     The purpose of this study is analyze if spirometry is a motivational element for changes in~     the cessation phases of the tobacco habit, compared with not done spirometry.~   "
14454|NCT03377725|"~     This is a prospective,controlled and multi-institution trial.The aim is to identify if using~     decitabine and Arsenic Trioxide(ATO) as the therapy of Myelodysplastic Syndrome(MDS) has~     better relapse free survival and complete response than using decitabine alone.~      TP53 mutation is commonly associated with poor cancer patient prognosis yet no mutant p53~     (mp53)-targeting regimen was clinically established. Particularly, p53 mutation is associated~     with extremely poor prognosis in myelodysplastic syndromes (MDS) and acute myeloid leukemia~     (AML) patients.~      Decitabine (DAC) is a FDA approved drug for MDS treatment. In two independent clinical trials~     reported recently, DNA demethylating drug DAC treatment yielded a surprisingly high rate of~     complete remission (CR) in mp53-harboring AML/MDS patients (Welch, NEJM, 2016; Chang, BJH,~     2017). Notably, all of the mp53-expressing patients in the two clinical studies relapsed~     quickly.~      Arsenic trioxide (ATO) is a FDA approved drug for M3-AML treatment. Despite of the observed~     efficacy in treating non-APL patients, ATO is not yet approved for non-APL cancer treatment.~     ATO plays key role in regulating both wild-type p53 (wtp53) and mp53. Our published and~     unpublished data suggest ATO potentially hijacks nuclear iASPP-mediated STRaND pathway via~     exposing iASPP's RaDAR nuclear import code (Lu, Cancer Cell, 2013; Lu, Cell, 2014; Lu, Nat~     Rev Mol Cell Biol, 2016; Lu, unpublished). Our unpublished data also suggests a key role of~     ATO in regulating mp53 (Lu, The 17th International p53 Workshop, 2017). ATO is widely~     reported to be able to degrade and thus inhibit mp53's oncogenic function (Hamadeh, BBRC,~     1999)(Liu, Blood, 2003). ATO suppressed cancer cell growth by targeting mp53 for degradation~     by Pirh2 degradation pathway (Yang, JBC, 2011; Yan, PLOS one, 2014);~      Here we explore the potential of combination of DAC and ATO in improving the mp53-harboring~     AML/MDS patients' relapse free survival (RFS) and the ability to thoroughly eliminate mp53~     subclone. Basic researches aiming to explore the mechanisms how mp53 cells responds to DAC~     and/or ATO treatment and how mp53 cells develop resistance to DAC and/or ATO will be coupled.~     We designate trials aiming for a better treatment regimen for mp53 patients as~     'PANDA-Trials'.~   "
14455|NCT03377712|"~     To evaluate the surgical repercussions in patients with traumatic brachial plexus injury in~     the respiratory and motor systems, trunk biomechanics, functional capacity and quality of~     life.~   "
17408|NCT03339102|"~     The objective of this study is to evaluate the safety and effectiveness of Humira®~     (Adalimumab) for the treatment of non-infectious intermediate, posterior, or panuveitis~     patients under a routine treatment practice.~   "
14456|NCT03377699|"~     The investigators are doing this study to see the effect of insulin degludec in pregnant~     women with type 1 diabetes, and if it is safe to use. In this study the medicine insulin~     degludec is compared to another medicine called insulin detemir. Participants will either get~     insulin degludec or insulin detemir and take it together with a medicine called insulin~     aspart - which treatment participants get is decided by chance. Participants will get~     pre-filled insulin pens. Participants will need to take blood sugar measurements several~     times a day. The study will last between 10 and 25 months depending on whether participants~     are already pregnant when they join the study. The number of visits and the tests ( for~     example blood and urine samples and ultrasound scans) the participants will have also depends~     on whether they are pregnant at study start.~   "
14457|NCT03377686|"~     In this study new hand-held devices for measuring exhaled breath will be tested in children~     with asthma, CF, and healthy controls. Main objectives will be feasibility and discriminative~     value of these techniques.~   "
14458|NCT03377673|"~     Pulmonary hypertension results in right ventricle dysfunction. Cardiac magnetic resonance~     derived RV ejection fraction is a prognostic value in this condition.~      Right ventricular geometry, function, morphology as well as pulmonary arterial stiffness and~     size may be evaluated by cardiac magnetic resonance imaging and could have great importance~     in evaluation of pulmonary hypertension prognosis and outcomes.~   "
14459|NCT03377660|"~     The investigators aim to ascertain how food reward signals and eating behaviour relates to~     the gut-brain pathway in weight-losing patients after curative surgery for oesophageal~     cancer, and how this pathway responds to clinical treatment for this unintentional weight~     loss. The primary outcomes are the blood oxygen level dependent (BOLD) signal on functional~     MRI (fMRI), and the breakpoint during the progressive ratio task (PRT - a measure of eating~     behaviour), how these differ in response to multiple clinical treatment options, as well as~     how they relate to weight gain while on treatment.~   "
14460|NCT03377647|"~     National Jewish Health and The University of Arizona worked with Navajo Nation organizations~     to develop this program to improve the health of children with asthma. The Navajo Community~     Asthma Program will have two main parts. One will train doctors and health care professionals~     to improve the diagnosis and treatment of asthma. The second part will work with area schools~     to provide education to school nurses, teachers, and children to help them better understand~     asthma. The project also works with families to help them know how to best take care of their~     child's asthma. A major project aim is to make sure that doctors, teachers, and families work~     together to manage asthma.~   "
14461|NCT03377634|"~     Chronic pain contributes to declining health and function in older adults; effects that are~     intensified by obesity and sedentary (sitting) behavior. The purpose of this study is to~     develop and test a novel, patient-centered intervention to reduce pain and improve physical~     function in older, obese adults. The study will utilize a combination of telephone based~     coaching and smartphone tools to deliver this novel intervention to decrease both body weight~     and sitting behavior. The long-term goals of this project are to test the efficacy of the~     intervention and to develop it as a tool for clinicians to provide outside-of-clinic~     patient-centered support for overweight/obese older adults with chronic pain.~   "
14462|NCT03377621|"~     Obstructive Sleep Apnea (OSA) is a serious medical condition which is increasing in the~     United States and significantly increases risks for other diseases, morbidity and mortality.~     The most common treatment for OSA is CPAP (Continuous Positive Airway Pressure), but this~     intervention has low patient compliance, significant expense ($800-2,000/set), and high~     inconvenience. Whole Body Vibration (WBV) training is a novel OSA intervention which could~     have higher patient compliance, low expense, and potentially lower morbidity and mortality~     and improved quality of life in this increasing patient population.~   "
14463|NCT03377608|"~     Two-armed, single visit, pharmacokinetic study to compare tenofovir diphosphate~     concentrations in cervical tissues of women on Depo-Provera contraception vs non-hormonal~     contraception.~   "
14464|NCT03377595|"~     Evaluating the safety and efficacy of EXPAREL (Liposomal Bupivacaine ) for pain control in~     patients undergoing scheduled cesarean section by giving it either as infiltration in~     Transversus Abdominis Plane after finishing the procedure or through wound infiltration into~     the fascia prior to closure of skin~   "
14465|NCT03377582|"~     The aim of this study is to investigate engagement, motivation, and the barriers to adherence~     of virtual reality based therapy (VRBT) in patients with cardiac diseases and risk factors to~     the development of cardiac diseases. In addition, to investigate autonomic and hemodynamic~     responses of VRBT in comparison with conventional therapy (CT). To do this, patients with~     cardiac diseases or risk factors will be invited to perform CT or VRBT+CT. They will be~     submitted to an initial evaluation, and then will be random allocated to 12 weeks of~     intervention and to a final evaluation. The primary outcomes includes engagement, motivation,~     barriers and adherence in the 12 previous weeks using questionnaire, after 12 weeks of the~     intervention and after 12 weeks of the final intervention program. Hemodynamic and autonomic~     responses will be considered the secondary outcomes being evaluated before, during and after~     a session at the first, sixth and twelfth week.~   "
14466|NCT03377569|"~     Sleep problems are common in the United States (US) adult population (>50 million), and have~     a negative impact on quality of life, productivity, and healthcare. A major obstacle to~     understanding how the brain is involved in human sleep disorders has been the lack of~     recordings of human brain function, from inside the brain, during the known sleep states.~   "
14467|NCT03377556|"~     This phase II trial studies how well talazoparib works in treating patients with homologous~     recombination repair deficiency (HRRD) positive stage IV squamous cell lung cancer that has~     come back after previous treatment. Talazoparib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth.~   "
14479|NCT03377400|"~     This is a single arm phase II study, in which 2 cycles of chemotherapy (5FU/CDDP) and~     immunotherapy (durvalumab and tremelimumab) are administered every 3 weeks with concurrent~     radiotherapy for inoperable locally advanced esophageal squamous cell carcinoma. Four weeks~     after completion of CCRT combined with immunotherapy, 2 cycles of durvaluma and tremelimumab~     will be administered every 4 weeks and thereafter durvalumab monotherapy Q4W will be~     maintained until unacceptable toxicity or disease progression, or for maximum 2 years after~     enrollment.~   "
14468|NCT03377543|"~     Goal of this project is to investigate whether increases in inflammation that result from~     common patterns of restricting sleep on week nights and catching up on sleep over the weekend~     are caused by disruption in the newly discovered inflammatory resolution pathways. These~     pathways are crucial in the active termination of the inflammatory response, and their~     disruption may contribute to ongoing unresolved inflammation, which has been observed not~     only during periods of sleep restriction, but also after recovery sleep has been obtained. If~     the hypothesis is true, it is possible that increasing the body's natural production of~     endogenous, inflammatory resolution mediators may provide a non-behavioral strategy to limit~     the inflammatory consequences in those undergoing periods of sleep restriction with~     intermittent recovery sleep.~   "
14469|NCT03377530|"~     Bacillus species are ubiquitous gram-positive spore-forming organisms. They rarely cause~     disease in the immunocompetent and are more frequently isolated as a culture contaminant.~     However, Bacillus Species can cause severe systemic infections in immunocompromised patients~     including preterm infants.~      The purpose of this study is to identify the risk factors of these infections.~   "
14470|NCT03377517|"~     This research is being done to see if a delivery of a single high dose of radiation therapy~     to a small area of the pituitary gland and pituitary stalk in a highly precise manner may be~     helpful in reducing intractable pain from bone metastases.~   "
14471|NCT03377504|"~     CRPS Type 1 can occur after traumas, surgical applications or central nervous system~     disorders. The triggering factor in CRPS type 1 is fracture in about half of the cases.~     Mirror therapy is an innovative treatment approach that is cheap, easy to administer and~     non-invasive. It is thought that this treatment may be complementary to other rehabilitation~     methods.Neurophysiologic effects of mirror therapy are noted in the brain, especially in the~     parietal region, cerebellum, basal ganglia and premotor cortex. Mirror therapy is also~     effective through the mirror neuron system. Mirror therapy triggers neuroplasticity by~     increasing the connection between neurons in the brain and thereby enhances communication~     between the motor and the sensory cortex. Recent studies have shown the positive effects of~     mirror therapy in patients with CRPS Type 1 disease. There are two randomized controlled~     trials showing the efficacy of mirror therapy in patients with CRPS Type 1 after stroke. Only~     one pilot study was performed in patients with CRPS Type 1 who were traumatic origin. There~     are no randomized controlled trials investigating the efficacy of mirror therapy in CRPS Type~     1 patients who developed secondary to trauma in the literature. The purpose of this study is~     to investigate the clinical effects of mirror therapy applied in addition to routine~     rehabilitation program in patients with traumatic CRPS Type 1. The investigators hypothesized~     that adjunctive mirror therapy to classical rehabilitation program would result in better~     outcomes compared with the classical program only.~   "
14472|NCT03377491|"~     Brief Summary:~      The study is a prospective, randomized controlled phase III trial aimed to test the efficacy~     and safety of Tumor Treating Fields (TTFields) in combination with gemcitabine and~     nab-paclitaxel, for front line treatment of locally-advanced pancreatic adenocarcinoma.The~     device is an experimental, portable, battery operated device for chronic administration of~     alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by~     means of surface, insulated electrode arrays.~   "
14473|NCT03377478|"~     To perform a study (100 patients) utilizing Hepatitis C positive (HCV Ab+/NAT -) donor lungs~     for hepatitis C negative recipients with post-operative surveillance and treatment only if a~     recipient infection occurs.~   "
14474|NCT03377465|"~     A stroke is the second cause of deaths after heart attack, one of the most important causes~     of malfunction as far as adults are concerned and the second as for the frequency cause of~     dementia. In spite of a possibility of the therapy of stroke ( tissue plasminogen activator)~     and recognized most of risk factors there is expected that incidence rate on stroke connected~     with ageing of the society will be growing. It will cause medical and social consequences.~      There are many of potential causes of cardiac strokes, which are not entirely examined.~      More over many cryptogenic strokes are presumed to have an embolic etiology, and the frequent~     cause of these kind of strokes at young age is probably the mechanism of paradoxical embolism~     through patent foramen ovale.~      As far as the investigators are concerned, at present there is lack of any recommendations~     for these scientific hypothesis.~   "
14475|NCT03377452|"~     This study is a randomized controlled trial (RCT) to test two sleep apnea education programs~     for women Veterans newly diagnosed with sleep apnea (SA) who are prescribed positive airway~     pressure (PAP) therapy. This education program is designed to improve participants' sleep~     quality and help them to adjust to PAP therapy.~      Participants will undergo a sleep and health assessment that will be performed prior to~     beginning the education program. This assessment includes wearing a wrist actigraph to~     measure sleep and wake periods for 7 days and nights, and answering questionnaires about~     sleep habits and health. Participants will be randomly assigned to one of two 6-week~     education programs provided by a study interventionist. Follow-up sleep and health~     assessments will be conducted at the end of the 6-week education program and 3-months later.~     PAP usage data will be collected remotely for 12 months from PAP therapy initiation.~   "
14476|NCT03377439|"~     It seems reasonable to assume that patients who present significant bleeding symptoms may~     have different quality of platelets than those without bleeding. This question was addressed~     in a study that examined platelet function in adult ITP patients, which try to determine~     whether this correlated with bleeding risk. Previous reports have suggested that measuring~     platelet function may help define patients at highest risk of bleeding. In addition,~     Middelburg and colleagues corrected platelet function for quartile of platelet count, using~     ＜32×10^9/L as the lowest cohort and ＞132×10^9/L as the top quartile. They demonstrated that~     increased platelet reactivity (as measured by flow cytometry) was associated with decreased~     risk of bleeding but particularly for those patients with the lowest platelet counts. Further~     studies in a larger cohort are needed to confirm this correlation. Our study aimed at~     standardizing a prediction model to evaluate the bleeding risk of adult ITP patients with the~     use of platelet function tests.~   "
14477|NCT03377426|"~     The purpose of the study is to evaluate whether LYS228 can be developed for the treatment of~     complicated urinary tract infections~   "
17409|NCT03339089|"~     The objective of this study is to evaluate the effect of adalimumab on health outcomes in~     participants with rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis.~   "
14480|NCT03377387|"~     This is a phase I study. The purpose of this study is to test the safety of the study drug~     neratinib in combination with a standard chemotherapy drug called capecitabine at different~     doses to find out what effects, if any, it has on people. Capecitabine (Xeloda®) is approved~     by the Food and Drug Administration (FDA) for advanced breast cancer treatment. Neratinib is~     an investigational drug, meaning the FDA has not approved the use of this drug for advanced~     breast cancer. The combination of capecitabine and neratinib has been studied before in~     another study where capecitabine was administered using the standard dosing schedule. In this~     study, the investigators want to find out if a different dosing schedule of capecitabine~     combined with neratinib is safer. This different dosing schedule is experimental, meaning the~     administration schedule of capecitabine and neratinib is not FDA approved for treatment for~     HER2 positive advanced breast cancer.~   "
14481|NCT03377374|"~     RCT in children (6m to 5y) with pharyngitis and/or tonsillitis who will be allocated to~     receive for 10 days L. reuteri DSM 17938 + L. reuteri ATCC PTA 5289) at a dose of 2x10^8~     Colony Forming Units (CFU). Five drops are to be taken twice a day (in the morning and in the~     evening) or placebo drops, as treatment for clinical condition. Duration of symptoms and~     reduction of pain (odynophagia) severity during treatment will be measured as primary outcome~   "
14482|NCT03377361|"~     The purpose of this study is to investigate treatment with Nivolumab in combination with~     Trametinib with or without Ipilimumab in patients with previously treated cancer of the colon~     or rectum that has spread.~   "
14483|NCT03377348|"~     Pterygium is characterized by encroachment of a ﬂeshy fibrovascular tissue from the bulbar~     conjunctiva on to the cornea. Although previously thought to be a solely degenerative~     disease, a new evidence has demonstrated the role of cell proliferation and inflammation in~     the pathogenesis of pterygium , and also by the clinical data that steroids are beneﬁcial in~     halting progression of impending recurrent pterygium . Many techniques have been developed~     for pterygium surgery over time. The simple method of removing the head and body of pterygium~     and leaving the sclera uncovered, the so-called bare-sclera technique, has been associated~     with high recurrence rates of 32-88% . To reduce the recurrence rate after pterygium surgery~     with a bare-sclera technique, various adjunctive modalities have been used such as chemical~     agents including mitomycin C , 5-ﬂuorouracil . Furthermore, when removal of pterygium is~     accompanied with a graft, such as conjunctival autograft or amniotic membrane transplantation~     , lower recurrence rates have been achieved . However, it remains unclear why the bare sclera~     technique has poorer outcome with higher recurrence rate than other procedures.~   "
14484|NCT03377335|"~     Dapagliflozin is a member of the sodium-glucose cotransporter-2 (SGLT2) inhibitor class~     antidiabetes agents which produces significant and sustained reductions in glycemic~     parameters in patients with type 2 diabetes (T2DM). However, its non-glycemic effects are~     still largely unknown.~      The investigators will evaluate for the first time the effect of dapagliflozin on multiple~     cardio-metabolic risk markers in one study. So far, no data on the effects of dapagliflozin~     as well as other SGLT-2 inhibitors on subclinical atherosclerosis, endothelial function,~     inflammatory markers, cytokines and atherogenic lipoproteins is available.~      In addition, the investigators will examine microRNAs (miRNAs) implicated in the development~     and progression of atherosclerotic disease. Again, no data is currently available on~     dapaglifozin's as well as other SGLT-2 inhibitors' effects on miRNAs.~      The results of this study will show for the first time the potential multiple, non-glycemic~     effects of dapagliflozin, reducing multiple cardio-metabolic risk markers, which will~     ultimately lead to decreased CV risk.~      In addition, specific mechanisms of the dapagliflozin cardiovascular action will be~     investigated.~      Finally, the results of this study may pave the way for personalized therapy (using the~     results on miRNAs).~   "
14485|NCT03377322|"~     This is a double blinded randomised placebo controlled trial to evaluate the efficacy of~     probiotics in the treatment of constipation in Parkinson's disease.~   "
14486|NCT03377309|"~     Amyotrophic lateral sclerosis (ALS), the most common motor neuron disease, is a fatal~     progressive neurodegenerative disease affecting motor cortex, brainstem and spinal cord~     leading to motor neuron death. It is a devastating disease of the anterior and lateral~     corticospinal tracts with approximately 3 years mean duration from symptoms onset to death,~     one-fifth survival at 5 years and only 10% may make it to 10 years.~      Among the neuronal death pathways, excitotoxicity mechanism is considered to be the~     foremost-involved mechanism. AMPA receptors are thought to be the prime mediator of the fast~     excitation in spinal motor neurons, where they are expressed ubiquitously. AMPA receptor~     antagonist was able to prevent this acute degeneration in previous animal studies.~      The investigators aim to study the tolerability and safety of the novel AMPA antagonist,~     perampanel, in patients diagnosed with ALS. Perampanel [2-(2-oxo-1-phenyl-5-~     pyridin-2-yl-1,2-dihydropyridin-3-yl) benzonitrile] with its selective non-competitive AMPA~     antagonism, was recently approved for epilepsy. Various long-term trials studying perampanel~     in epilepsy showed favorable tolerability profile and most common side effects were mainly:~     dizziness, headache and somnolence. All patients presenting to Neurology clinics at AUBMC~     diagnosed with Amyotrophic Lateral Sclerosis, will be considered for the study. Investigators~     will obtain informed consents from all patients who agree to be enrolled in this study in~     accordance with institutional review board (IRB) requirements. Patients of both genders and~     over 18 years old who meet the El Escorial criteria for possible, probable or definite ALS~     and fit the inclusion criteria will be recruited. Subjects should not be started on riluzole~     for the past 30 days or stable on a dose of riluzole for at least 30 days prior to the~     screening process.~      In titration phase, perampanel dose will be increase by 2mg/day increments every one week to~     reach a maximum dose of 8 mg/day; reaching the maximum dose in four weeks. Treatment phase~     will be followed by washout period during which, dose will be tapered by 2mg/day every 5 days~     (over total of 15 days).~   "
14487|NCT03377296|"~     This is a sporozoite-challenge clinical study with the primary aim of assessing the safety~     and feasibility of controlled human P. vivax malaria infection in two healthy volunteers. The~     investigators will also assess the growth of and the immune response to P. vivax infection,~     and assess the induction of sexual gametocytaemia post-CHMI via the natural route of malaria~     infection (mosquito bite). A secondary objective is to develop a blood inoculum of P.~     vivax-infected blood for future testing of candidate vaccines.~   "
14498|NCT03377153|"~     To study the effects of Hesperidin and flaxseed supplement on lipid profile, liver enzymes,~     inflammatory factors and hepatic fibrosis in patients with Nonalcoholic Steatohepatitis~     (NASH), 50 patients who referred to Gastrointestinal (GI) clinic with steatosis grade 2 and 3~     will be randomly allocated to contol group or 2 capsules Hesperidin and 30 gram flaxseed for~     12 weeks; both groups will be advised to adherence the investigators' diet and exercise~     program too. At the first and the end of the intervention, lipid profiles, liver enzymes,~     some inflammatory markers, and liver fibrosis will be assessed and compared between groups.~   "
14488|NCT03377283|"~     The increasing demand for organ transplantation and the shortage of available organs limit~     the success of organ transplantation programs. Consequently, acceptance of expanded criteria~     donor (ECD) organs with the consequences of higher risk of unfavorable transplantation~     outcome has become an increasing reality. Among the most prominent characteristics~     distinguishing ECD from Standard Criteria Donors (SCD) are risk factors including brain death~     (BD) or prolonged cold ischemia time (CI) amplifying ischemia reperfusion injury (IRI).~     Currently there are no standard regimens to improve the quality of ECD organs. Therefore,~     donor organ treatment might be a promising approach to substantially improve organ quality.~     It will be investigated whether the application of the peri-operative perfusion of kidneys~     and livers with the polyclonal antibody rabbit antithymocyte globulin (rATG) ameliorates IRI.~      This trial is designed as a parallel armed randomized controlled trial.~   "
14489|NCT03377270|"~     Veterans following treatment of head and neck cancer can be left with lasting swallowing~     impairment that may require diet alterations, need for feeding tubes, and risk of pneumonia.~     The investigators' previous trial tested a new swallowing treatment approach to target~     respiratory-swallow coordination. The results revealed improvements in respiratory-swallow~     coordination and swallowing function. The goal of this study is to determine the impact and~     durability of respiratory-swallow training (RST) on clinical outcomes necessary for eating,~     drinking, health, and quality-of-life in Veterans with swallowing impairment following~     treatment for head and neck cancer. A total of 88 participants will be recruited and randomly~     assigned to the RST or standard of care. An additional 11 participants will be recruited to~     RST plus a home practice portion to obtain preliminary data regarding efficacy of home~     practice.~   "
14490|NCT03377257|"~     The purpose is to evaluate the effectiveness and safety profile of zolmitriptan by Sublingual~     administration for the acute treatment of Cluster headache.~   "
14491|NCT03377244|"~     The study aim is to pilot test and compare the effectiveness of achieving weight loss between~     implementation of: 1) the Diabetes Prevention Program Lifestyle Intervention (DPP-LI) and 2)~     Healthy Bodies Healthy Souls (HBHS) intervention which includes the same DPP-LI with the~     additional enhancement of working with Marshallese churches to implement~     organizational/institutional level changes to support the individual behavioral intervention~     of the DPP-LI.~   "
14492|NCT03377231|"~     Stretch marks (striae distensae) are a form of scarring that is a natural result of~     pregnancy, obesity and in some instances occur due to puberty or steroid use. For some~     people, the stretch marks do not cause a problem, but in many circumstances they can cause~     physical symptoms such as itchiness, tenderness and pain. For many people stretch marks are~     also embarrassing and can have detrimental effects on a patient's mood and self-esteem.~     Stretch marks that result from pregnancy most commonly occur on the abdomen, breasts and~     thighs.~      Topical silicone gel was developed nearly thirty years ago to be used in the treatment of~     widespread hypertrophic scars (abnormal scars, which may be red or raised/depressed itchy or~     painful). Since this time it has been used successfully on most scar types. . Since stretch~     marks are a form of scarring it is thought that topical silicone gel may be helpful for this~     scar type also. Stratamark™ has been developed using different forms of silicone polymers, in~     a gel format, that dries to form a very thin and flexible silicone gel sheet making it a~     convenient therapy for the treatment and prevention of stretch marks.~      The aim of this clinical research study is to prove or disprove the efficacy, safety and~     tolerability of Stratamark™ in the prevention and treatment of stretch marks. In addition,~     the knowledge gained from this study may be of benefit to many future patients~   "
14493|NCT03377218|"~     In 1994, the WHO and UNICEF Joint Committee on Health Policy recommended Universal Salt~     Iodization as a safe, cost-effective and sustainable strategy to ensure sufficient intake of~     iodine by all individuals. However, it is still absent in Latvia.~      A recent countrywide study in 2013 shows iodine deficiency among pregnant women in Latvia: 81~     % of pregnant women had UIC levels below the WHO recommended range of 150-250 mcg/g Cr.~      Because mild to moderate iodine deficiency during pregnancy can adversely affect fetal brain~     development, WHO-UNICEF and ICCIDD advise an increase in the recommended daily dosage of~     iodine to 250 mcg/day for pregnant women and breastfeeding women and 150 mcg/day for women in~     the preconception period.~      Data from a survey of the Latvian population indicate that approximately 100 mcg of iodine~     per day is consumed through foods and iodized salt. To meet the increased iodine requirement~     in pregnancy, pregnant women should take a supplement containing 150 mcg of iodine daily from~     the earliest time possible.~      A sudden increase in iodine intake in an iodine-deficient population may increase thyroid~     autoimmunity. It is evident that thyroid disease has multiple adverse effects during~     pregnancy and in the developing fetus especially in women with elevated serum anti-thyroid~     antibody titers.~      Studies have considered supplementing with selenium to reduce the risk of auto-immune~     thyroiditis/post-partum autoimmune thyroid disease. Of the 11 trials of selenium~     supplementation in patients with autoimmune thyroiditis, 7 have shown benefit with treatment~     for 6 months or longer.~      Aim of study is to approve that 150 mcg of iodine daily improves iodine status in pregnant~     women and iodine 150 mcg in combination with selenium 100 mcg daily reduce risk of thyroid~     autoimmunity.~      Hypothesis of study is that 150 mcg iodine daily during pregnancy improves iodine status.~     Iodine in combination with selenium is less associated with thyroid autoimmunity.~      Study design: Pregnant women are randomized for either 150 mcg iodine intake daily or 150 mcg~     iodine combined with 100 mcg selenium daily. Interventional group is compared with controls~     without particular iodine supplementation.~      Participants are asked to complete a questionnaire on dietary habits concerning iodine.~     Thyroid function (thyroid-stimulating hormone, free thyroxine) and thyroperoxidase antibodies~     (TPO-Ab) and urinary iodine are measured during first, second and third trimester of~     pregnancy and week 8 after delivery in both, intervention and control group.~   "
14494|NCT03377205|"~     The purpose of this study is to make a survey of functional outcome, radiological outcome and~     complication rate after intramedullary nailing (IMN) and plate fixation of Weber B ankle~     fractures in elderly patients, and contribute in choosing the best surgical method for these~     ankle fractures.~   "
14495|NCT03377192|"~     This study evaluates the value of impedance pneumography, used as overnight home recordings~     during a longitudinal design, in assessing asthma control in preschool children~   "
14496|NCT03377179|"~     ABC-108 is a single-arm Phase IIA clinical study of ABC294640 (Yeliva ®) in the treatment of~     cholangiocarcinoma (CCA). In this clinical study, all participants will be receiving~     ABC294640. The study drug, ABC294640 is an orally available inhibitor of the enzyme~     sphingosine kinase-2 (SK2). SK2 is an innovative target for anti-cancer therapy because of~     its critical role in sphingolipid metabolism, which is known to regulate tumor cell death and~     proliferation. ABC294640 also inhibits proliferation and induces apoptosis of~     cholangiocarcinoma cell lines. Furthermore, in a recent Phase I trial, ABC294640 demonstrated~     clinical activity in CCA patients. In this study, ABC294640 will be continuously~     administrated orally, twice a day, in 28 day cycles, until disease progression, unacceptable~     toxicity or voluntary withdrawal initiated by the participants or physician.~   "
14497|NCT03377166|"~     A comparison between two methods evaluating SVV: Bucket Test and A smartphone-based test.~   "
14499|NCT03377140|"~     To study the effects of Hesperidin supplement on lipid profile, liver enzymes, inflammatory~     factors and hepatic fibrosis in patients with Nonalcoholic Steatohepatitis (NASH), 50~     patients who referred to Gastrointestinal (GI) clinic with steatosis grade 2 and 3 will be~     randomly allocated to receive placebos or 2 capsules Hesperidin for 12 weeks; both groups~     will be advised to adherence the investigators' diet and exercise program too. At the first~     and the end of the intervention, lipid profiles, liver enzymes, some inflammatory markers,~     and liver fibrosis will be assessed and compared between groups.~   "
14500|NCT03377127|"~     The internal medicine clinic at Beaumont Hospital - Royal Oak cares for over 900 patients~     with diabetes. In an effort to improve the care provided to our patients, a pharmacist~     managed diabetes clinic (PMDC) was created. The investigators looked at patients with~     high-risk diabetes who have received education in the PMDC and compared them to patients that~     didn't not receive the pharmacy education. Our preliminary data showed a significant decrease~     in Hemoglobin A1c in the PMDC compared to our standard care cohort. Hemoglobin A1c is a~     marker of the severity of diabetes mellitus. Based on this data, we designed a randomized~     controlled trial to better assess the impact of a PMDC on diabetic outcomes.~   "
14501|NCT03377114|"~     The goal of this prospective randomized controlled study is to investigate the effect of head~     tilting on tracheal tube passing during nasotracheal intubation.~      The question which the investigators are trying to answer is: If patient's neck is extented~     on inserting tracheal tube via nostril, will the E-tube be more easily to pass through~     nasopharynx to oropharynx without trapping?~   "
14502|NCT03377101|"~     This randomized phase II trial studies the side effects and how well fulvestrant and~     palbociclib with or without copanlisib work in treating patients with hormone receptor~     positive, HER2 negative, stage IV breast cancer. Fulvestrant, palbociclib, and copanlisib may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
14503|NCT03377088|"~     Pain control for acute isolated back pain and sciatica is a nebulous and often illusive task~     in the emergency department, and a challenge face everyday by emergency medicine physicians.~     Standard pain control practices are poorly defined in practice and in the literature. NSAIDs~     alone have been shown to be less-than-adequate controllers of acute back pain warranting~     emergency department visits and have little bearing on long-term pain control or recovery.~     Opioids are additionally poor long-term pain controllers and are gaining public controversy~     for their overuse. Modalities such as acupuncture, massage, thermotherapy, and spinal~     manipulation have been described in the literature with minimal evidence. Aromatherapy for~     pain control has been recently demonstrated as effective in the management of burn-dressing~     changes as well as post-operative pain management in children. It is an inexpensive and~     easily employed modality not yet explored in the emergency department for acute pain such as~     isolated back pain and sciatica. The authors propose to study Rosa damascena oil aromatherapy~     for the control of isolated acute back pain in the emergency department compared to almond~     oil placebo. The authors hypothesize that Rosa damascena will provide additional pain relief,~     as a known analgesic, when compared to almond oil aromatherapy. The authors will identify~     patients presenting to the Stony Brook University Hospital (SBUH) Emergency Department (ED)~     with acute isolated back pain and sciatica and test this hypothesis using a blind randomized~     approach. Patients included will be those above the age of 18 with isolated, non-traumatic~     back pain and sciatica lasting less than 2 weeks. Primary outcomes measured will include~     decrease in pain severity on a visual analog scale after 30 minutes of aromatherapy and again~     at 60 minutes post-therapy. Secondary outcomes measured will include patient satisfaction,~     need for clinician-determined rescue medications, and minimal clinical importance difference~     of pain control. Aromatherapy will be provided with both essential oil concentrated Rosa~     damascena and almond extract delivered via soaked-cotton ball 20-30 cm from the patient's~     face.~   "
14504|NCT03377075|"~     The aim of the study is the non-invasive morphological evaluation of the choroid and the~     retina in relation to the length of the eyeball in healthy, young man and women.~   "
14505|NCT03377062|"~     A CVA occurs when there is a sudden interruption of blood supply to the brain. Fast~     identification of CVA is crucial in order to refer the patient to an appropriate medical~     center as well as to direct him/her to a suitable treatment upon arrival to the Medical~     Center, in order to minimize the permanent damage to the brain. In this study, we are~     evaluating a tool for detecting CVA based on EEG (electroencephalograph) data analysis using~     innovative algorithm. The system is comprised of four electrodes, reference electrode and~     earphones for auditory stimulation. In the study, 120 patients arriving to the emergency room~     with decreased consciousness, severe headaches or dizziness will be monitored for five-minute~     each, with EEG accompanied with auditory stimulation. The EEG analysis will be performed~     based on the synchronization of the front and back hemispheres. During CVA, specific~     hemisphere is damaged, therefore desynchronization is expected. The purpose of this study is~     to develop a tool for identifying CVA in patients who have no clear CVA related signs.~   "
14506|NCT03377049|"~     The investigators propose a technique using cone beam CT perfusion (CBCTP) imaging with an~     acetazolamide challenge as a potential diagnostic tool to detect a defect in cerebral~     autoregulation at a time when it has not yet caused clinically apparent signs or symptoms.~     The Acetazolamide or vasodilatory challenge should identify subjects having a abnormal~     cerebrovascular reactivity capacity at a time before this response is needed i.e. before~     significant vasospasm has occurred. More specifically, after receiving the drug there will~     not be the expected increase in cerebral blood flow in some of the subjects because they are~     already suffering from a disturbance in the vasculature's ability to respond to the signal~     for vasodilation. The investigators believe that ultimately the presence of this deficit will~     be helpful in identifying patients who are at risk for potential brain ischemia due to this~     decreased capacity to autoregulate if/when clinically significant vasospasm occurs. The~     investigators predict that the technique described will be more sensitive in this regard than~     the presently available methods e.g. the severity of subarachnoid bleeding. If this is~     correct, the cone beam CT perfusion measurements would be a better predictor of those~     patients at risk for cerebral infarction due to delayed vasospasm. Identifying these~     individuals prior to the onset of clinically apparent symptoms would result in modification~     of their management and potentially provide the opportunity to reduce the morbidity and~     mortality associated with ischemic brain injury.~   "
14507|NCT03377036|"~     This study is a randomized, multicenter, multivendor, controlled, diagnostic superiority~     trial to compare digital breast tomosynthesis plus synthesized 2D mammograms (DBT+s2D) versus~     standard 2D full-field digital mammography (2D-FFDM) regarding the effectiveness as screening~     modality.~   "
14508|NCT03377023|"~     The main purpose of this study is to see if the combination of nivolumab, ipilimumab and~     nintedanib is effective in people with non- small cell lung cancer. Researchers also want to~     find out if the combination of nivolumab, ipilimumab and nintedanib is safe and tolerable.~   "
14509|NCT03377010|"~     This is a single center, cross-sectional, non-interventional study aimed at the nutritional~     intake of long-term health of allogeneic or autologous hematopoietic stem cell transplant~     (HSCT) survivors.~   "
14511|NCT03376984|"~     The purpose of this study is to to compare root canal therapy success between two root canal~     filler materials: 1) gutta percha (GP), 2) gutta percha modified with nanodiamonds and~     amoxicillin (NDGX). Gutta percha is the current standard root canal filler material used~     during non-surgical root canal therapy (RCT). Gutta percha modified with nanodiamonds and~     amoxicillin is an investigational root canal filler material, not yet FDA approved for use as~     described in this study. The safety and usefulness of NDGX is being tested in this study in~     comparison to the current standard of care, gutta percha (GP).~   "
14512|NCT03376971|"~     This pilot early phase I trial studies how well real-time optical biopsy works in improving~     lung cancer diagnosis in patients undergoing lung biopsy. Real-time optical biopsy using~     confocal microscopy may improve the ability of physicians to diagnose lung cancer and~     accurately differentiate cancerous and benign lesions found during computed tomography~     screening.~   "
14513|NCT03376958|"~     The purpose of this study is to evaluate the efficacy and safety of apatinib+Gemox regiment~     (gemcitabine，oxaliplatin, dexamethasone) for patients with Relapsed /Refractory Diffuse Large~     B Cell Lymphoma.~   "
14514|NCT03376945|"~     The safety and efficacy of ω-3 fatty acid in patients with obstructive jaundice is not known.~     This study provided evidences that ω-3 fatty acid-based parenteral nutrition improved~     postoperative recovery for patients with obstructive jaundice.~   "
14515|NCT03376932|"~     Asthma is a common, chronic respiratory disease affecting 1-18 percent of the population. It~     is accepted that much of the uncontrolled asthma is due to poor adherence and asthma outcomes~     in such cases may improve simply by increasing adherence to available treatments.~     GlaxoSmithKline (GSK) has developed a sensor, which clips on to the ELLIPTA® dry powder~     inhaler (DPI). This will inform subjects if/when they have taken their medication that is in~     the ELLIPTA inhaler, as well as other information, including: asthma management strategies,~     tracking of symptoms, asthma triggers, medication reminders and daily asthma forecasts. The~     sensors, application (app), and provider portal that provide data are subsequently described~     as the CIS. The combination of once-daily FF/UMEC/VI with the CIS will improve the disease~     management and adherence. Thus, this study is designed to study the effectiveness and~     adherence of single inhaler triple therapy (SITT) of FF/UMEC/VI with the CIS as compared to~     multiple inhaler triple therapy (MITT) of the combination of FP/SAL plus TIO without CIS in~     subjects with inadequately controlled asthma. The study randomization will be stratified by~     pre-study inhaled corticosteroids (ICS) dosage strength (mid- or high-dose). Subjects will be~     randomized in a 1:1 ratio to receive either FF/UMEC/VI delivered via the ELLIPTA DPI with the~     CIS or FP/SAL delivered via the DISKUS® DPI (with sensor only) plus TIO delivered via the~     RESPIMAT inhaler (without sensor). The maximum study duration will be approximately 29 weeks,~     which comprised of prescreen/ screening/ randomization period of up to 4 weeks, 24-week~     treatment period and a 1-week follow-up period. Approximately 1006 subjects will be~     randomized in the study. ELLIPTA and DISKUS are registered trademarks of GlaxoSmithKline~     (GSK) group of companies.~   "
14516|NCT03376919|"~     The aim of the study is to assess the efficacy and the usability of the cyberlegs ++ ortho~     prosthesis to improve the mobility and the quality of life in transfemoral amputees . This~     research focusses on the physical and mental effort needed in locomotion-related tasks and~     human robot interaction in transfemoral amputees using a novel active prosthesis. This is an~     international project and foresees 2 clinical studies aimed at assessing the efficacy of the~     CLs++ modules in different settings.~      In this first clinical study, 16 patients with unilateral trans-femoral amputation, 8 at the~     Vrije Universiteit Brussel Department Human Physiology Research group (VUB-MFYS) and 8 at the~     Don Gnocchi Foundation, center of Florence.~   "
14517|NCT03376906|"~     Obesity is a complex and multifactorial disease. Excess weight is related to endothelial~     dysfunction, inflammation and oxidative stress which increases the risk for cardiovascular~     diseases. High-intensity interval exercise can release vasodilatory substances and promote~     increased muscle blood flow.~   "
14518|NCT03376893|"~     Sickle cell anemia is a rare disease occurring in an estimated 66,000 children and adults,~     often poor and underserved, in the United States. Strokes and silent strokes contribute~     significantly to illness burden in adults with sickle cell anemia, resulting in impairment,~     challenges with school and job performance, and premature death. Five NIH studies have~     identified therapies to prevent overt and silent strokes in children with sickle cell anemia,~     including monthly blood transfusion therapy (for preventing initial and recurrent strokes)~     and hydroxyurea (for preventing initial strokes). However, no stroke trials have established~     therapeutic approaches for adults with sickle cell anemia, despite the observation that at~     least 99% of children with sickle cell anemia in high-income countries reach adulthood, and~     approximately 60% of adults will experience one or more strokes (~50% with silent strokes and~     ~10% with overt strokes). Strokes in adults with sickle cell anemia have simply not been well~     studied. Therapies applied in children may not be effective for stroke prevention in adults~     with sickle cell anemia. Identifying subgroups of adults with sickle cell anemia and higher~     incidence coupled with the contribution of established stroke risk factors in the general~     population (smoking, diabetes, obesity, renal disease) will provide the prerequisite data~     required for the first ever phase III clinical trials focused on secondary stroke prevention~     in adults. In six adult sickle cell disease centers, the investigators will conduct a~     prospective cohort study to test the primary hypothesis that the incidence of stroke~     recurrence in adults with silent strokes treated with hydroxyurea will be greater than in~     those without strokes treated with hydroxyurea. We will test two secondary hypotheses: 1)~     adults with sickle cell anemia and silent strokes have cognitive deficits when compared to~     adults with sickle cell anemia without silent strokes; and 2) adults with sickle cell anemia~     and strokes receiving regular blood transfusion will have a higher incidence of stroke~     recurrence than adults with sickle cell anemia without strokes. We will recruit at least 72~     individuals with sickle cell anemia and history of silent stroke receiving hydroxyurea~     therapy, at least 72 individuals with sickle cell anemia and no history of stroke, and at~     least 50 individuals with sickle cell anemia and history of overt stroke receiving~     transfusion therapy.~   "
14519|NCT03376880|"~     In obese children, excess fat on the thorax exerts an unfavorable burden on the respiratory~     system, particularly during exercise; however, it is unclear if this burden reduces exercise~     tolerance, provokes dyspnea on exertion, or contributes to respiratory symptoms that could be~     misdiagnosed as asthma, placing obese children at risk of unnecessary treatment and~     potentially a reluctance to exercise explaining reports of low physical activity and fitness~     levels, which are counterproductive to weight loss. The investigators will examine the~     respiratory effects of obesity in prepubescent boys and girls, including those with~     respiratory symptoms misdiagnosed as asthma, before and after 1) a program of weight loss and~     regular exercise and 2) continued weight gain as compared with prepubescent normal weight~     boys and girls before and after 1 year. These results will have broad and immediate clinical~     impact on the care of obese children, especially those with respiratory symptoms misdiagnosed~     as asthma, and the results could alter interventional approaches for preventing and treating~     childhood obesity.~   "
14520|NCT03376867|"~     Chronic pain (CP) is disabling for people triggering important costs for society. A deficit~     of diffuse noxious inhibitory controls (DNIC) is one of the CP mechanisms. DNICs are~     evaluated in research setting using a CPM protocol (conditioned pain modulation). There is a~     lack of reference values on the effectiveness of DNICs. Wider research on DNIC will help to~     understand CP and to develop a clinical screening test evaluating DNICs.~   "
14521|NCT03376854|"~     Acute Respiratory Distress Syndrome (ARDS) is a serious condition that occurs as a~     complication of medical and surgical diseases, has a mortality of ~40%, and has no known~     treatment other than optimization of support. Data from basic research, animal models, and~     retrospective studies, case series, and small prospective studies suggest that therapeutic~     hypothermia (TH) similar to that used for cardiac arrest may be lung protective in patients~     with ARDS; however, shivering and its metabolic impact is a major complication of TH, often~     requiring neuromuscular blockade (NMB) to control. NMB has now become part of standard of~     care for patients with moderate to severe ARDS. Since many of these patients are already~     receiving the ultimate anti-shivering therapy, the investigators reasoned that such patients~     would provide an ideal population for an RCT of TH in ARDS. The investigators have completed~     a retrospective study of patients with ARDS on NMB and an open label pilot study of TH in 8~     such patients that demonstrated feasibility and safety of performing such an RCT.~     Furthermore, a comparison of the subjects in the open-label study with the historical~     controls from the retrospective study suggested that TH will be beneficial in patients with~     ARDS. To generate further support for grant applications to support a Phase IIb multicenter~     RCT, the investigators plan on performing a small pilot single center RCT of TH (core~     temperature 34-35°C) for 48h vs. standard of care in patients with ARDS who are receiving~     NMB. Primary outcome will be 28 day ventilator-free days and secondary outcomes will include~     physiologic measures, mortality, hospital and ICU length of stay, and serum biomarkers~     collected on days 0, 1, 2, 3, 4, and 7.~   "
14522|NCT03376841|"~     The objective of this study is to assess the pharmacokinetics (PK), safety, and tolerability~     profiles of cenicriviroc (CVC) and its metabolites (M-I and M-II) in participants with~     severely impaired hepatic function compared with matched healthy participants following~     single-dose administration~   "
14523|NCT03376828|"~     During endotracheal intubation, it is known that la laryngoscopy has significant effects,~     such as tachycardia and blood pressure increase, which may be harmful, especially in those~     with cardiovascular disease. Different studies comparing laryngeal stimulation and there~     resulting hemodynamic response made with various intubation devices are available in the~     literature. The investigators planned to work with the hypothesis that endotracheal~     intubation with videolaryngoscopy would have less hemodynamic response traditional~     (Macintosh) laryngoscopy and the use of videolaryngoscopy would result in wider vision with~     less laryngeal stimulation.~   "
14524|NCT03376815|"~     The aim of this study is to establish large tissue sections for 10 kinds of tumors. in order~     to observe the tumor landscape on microscope. The tumors including esophageal~     carcinoma,gastric carcinoma,hepatocellular carcinoma etc.200 cases of each tumor will be~     compared by traditional sample method and landscape sample method to testify the clinical~     value and significance of tumor landscape pathological diagnosis .~   "
14525|NCT03376802|"~     Primary Objective:~      To assess in overweight to obese subjects the change in sleep energy expenditure after~     repeated subcutaneous (SC) doses of SAR425899.~      Secondary Objectives:~        -  To assess the change in resting, basal and total daily energy expenditure.~        -  To assess the change in respiratory quotient, fat, protein and carbohydrate oxidation.~        -  To assess the change in body composition and core temperature.~        -  To assess the pharmacodynamic effects on fasting plasma glucose, biomarkers of lipid~          metabolism and glycated hemoglobin (HbA1c).~        -  To assess the pharmacokinetic parameters for SAR425899 after repeated SC doses.~        -  To assess the safety and tolerability.~   "
14526|NCT03376789|"~     The aim of this study is to demonstrate similar efficacy and safety between MYL-1501D~     products produced from two manufacturing processes (Process V and Process VI) in combination~     with insulin lispro in patients with type 1 diabetes mellitus (T1DM).~   "
14527|NCT03376776|"~     We evaluated preoperative and postoperative optical coherence tomograpghic images in eyes~     with full thickness macular hole (FTMH) whether the epiretinal proliferation (EP) was~     detected and detection of EP was correlated to the visual improvement.~   "
14528|NCT03376763|"~     Interventional, multicenter, open-label, 20 weeks study~        -  To identify efficacy and safety in switching from oral aripiprazole to Abilify Maintena.~        -  To identify efficacy and safety in switching from oral atypical antipsychotics other~          than aripiprazole to Abilify Maintena~   "
14529|NCT03376750|"~     Most surviving hip-fracture patients experience reduced mobility and lose their functional~     ability, which increases the risk of complications and rehospitalization. Post-discharge~     transitional programs to reduce readmissions have shown some success. Telerehabilitation~     refers to the use of technologies to provide rehabilitation services to people in their~     homes. Considering the need for long-term follow-up care for people with hip fracture,~     in-home telerehabilitation could increase independence, decrease hospital stays and reduce~     the burden for caregivers.~      The purpose of this three armed randomized controlled trial is to investigate the~     effectiveness of an intervention program based on telerehabilitation on ADL, QOL, depression~     and burden on caregivers compared to face-to-face home visits and usual care of~     community-dwelling older adults after hip fracture.~      90 older people with hip fractures will be randomly assigned to a telerehabilitation group~     (N=30), face-to-face visits (N=30) and a control group.~      The aim of the intervention is to improve the transition from rehabilitation units to~     community dwelling. It will include 10 videoconferencing/ face-to-face sessions from an~     occupational therapist in the presence of the primary caregiver. Each session will be~     utilized to guide the participants to achieve their self-identified goals, focusing on~     problem-solving for daily life situations and on the ability to implement the discussed~     strategies for a variety of activities~   "
14530|NCT03376737|"~     The purpose of this study is to confirm the safety and efficacy of Apatinib plus Pemetrexed~     as the Maintenance Therapy in Advanced Lung Adenocarcinoma.~   "
14531|NCT03376724|"~     Non-specific low back pain is a common condition. Exercise is effective treatment for chronic~     low back pain. We hypothesized the functional exercise group will present pain reduction and~     functional improvement.~      The purpose of this study is investigated the effectiveness of an functional exercise program~     for people with nonspecific chronic low back pain. Patients will be randomly divided into 2~     groups: control group (minimal intervention - mini back school and analgesic) and group will~     receive a functional exercise protocol associated with minimal intervention.~   "
49169|NCT02923336|"~     The purpose of this study is to evaluate the influence of non betablockers in~     gastrointestinal motility (transit time) in patients with liver cirrhosis.~   "
14532|NCT03376711|"~     Ventilator assisted individuals (VAIs) living at home are frail and generally cannot perform~     most daily activities. Although these individuals prefer to live at home, the family members~     who care for them often experience stress and poor health. Peer support can mitigate health~     declines by decreasing caregivers' isolation/stress and increasing their sense of control.~     However, no peer support programs are designed to meet these caregivers' complex and unique~     needs. Online support delivery is especially beneficial for caregivers given the geographic~     and time limitations they face. The proposed research aims to develop and conduct an RCT of~     online peer support program for VAI caregivers. A group of caregivers will be trained to act~     as peer mentors. This training program will be evaluated for its impact on caregivers'~     mentoring abilities. At the end of the 12-week program, caregiving participants will be asked~     about the online delivery of the program, how helpful/satisfactory it was, and if it affected~     their health and well-being. The health outcomes of the control and intervention group will~     be compared. This peer support program can improve the well-being of caregivers and allow~     them to better care for their family members.~   "
14533|NCT03376698|"~     This study is designed to investigate dose-dependent effects of low dose colchicine on~     inflammatory responses, endothelial function in type 2 diabetic patients with coronary artery~     disease and leukocyte activation. This study also tested the relationship between doses and~     safety issue such as incidence of diarrhea. Eligible patients will be randomly allocated to~     three treatment group: colchicine at 0.5mg per day, 0.25mg per day or placebo for 12 weeks in~     a double blind , parallel group design. High sensitive-CRP at 4 weeks as primary end point~     and flow mediated vasodilatation at 12 weeks as the secondary end point will be measured.~   "
14534|NCT03376685|"~     Regular physical activity is well established to decrease the risk of cardiometabolic~     diseases, however these beneficial effects are largely dependent on the type of exercise~     protocol conducted. The purpose of this study is to directly compare the efficacy of~     endurance (END), sprint (SIT), or combined endurance-sprint (COMB) training in respect to~     reducing clinically relevant cardiometabolic risk factors in pre-diabetic individuals. It is~     hypothesized that:~        1. END and COMB will elicit favourable cardiovascular adaptations, which will be absent in~          response to SIT.~        2. END and COMB protocols of greater frequency will markedly improve metabolic health in~          comparison to a lower frequency SIT protocol.~   "
14535|NCT03376672|"~     This study will evaluate the efficacy and safety of 3-drug all-oral combination, ixazomib~     plus lenalidomide plus dexamethasone (IRd) as induction treatment for autologous stem cell~     transplantation eligible patients followed by IRd consolidation and risk based maintenance~     treatment with IR or R alone.~   "
14536|NCT03376659|"~     This is a dual arm, open label phase I/II study to evaluate the safety and clinical activity~     of the combination of durvalumab with CV301 in combination with maintenance chemotherapy for~     patients with metastatic colorectal or pancreatic cancer whose disease is stable on, or~     responding to 1st line therapy for metastatic disease. Patients with metastatic colorectal or~     pancreatic adenocarcinoma who still have an adequate performance status and normal hepatic~     and renal function will be eligible.~   "
14537|NCT03376646|"~     The purpose of this study is to evaluate the efficacy and safety in the treatment of Coronary~     Small Vessel Disease by drug coated balloon (DCB) Dissolve™ versus drug eluting stent (DES)~     Resolute™ Integrity.~   "
14538|NCT03376633|"~     The purpose of this study is:~        1. To conduct a randomized controlled trial to evaluate the impact of Working on Womanhood~          (WOW), a school-based, trauma-informed counseling and clinical mentoring program for~          young women in Chicago, on PTSD, anxiety, depression. In addition, this study will~          examine the effect of WOW on other, secondary outcomes such as school discipline, GPA,~          high school graduation, and criminal justice involvement, risky behaviors, and other~          social-emotional learning outcomes.~        2. To evaluate the cost-effectiveness of the WOW program.~   "
14539|NCT03376620|"~     Linked to previous Clinical Trial E92:069 in which biochemical effect of 1,4 diaminobutane~     was studied in human scar harvested at revision surgery after a 12 week application.~     Analytical data was collected in this phase of the work completed in 1999. This was then~     followed by clinical correlation in a scar prevention model with topical application of 1,4~     diaminobutane for 12 weeks and measuring duredness , as well photographic and POSAS score~     data for quality of scar formation.~   "
14540|NCT03376607|"~     The Home Based Care Practitioners (HBCPs) programme has been established by the Rwandan~     Ministry of Health in response to the shortage of health professionals. Currently in its~     pilot first phase, it entails laypeople providing longitudinal care to chronic patients after~     receiving a six-month training.The diabetes mellitus (DM) prevalence in Rwanda is estimated~     at 3.5%. Technological mobile solutions can improve care by enabling patients to self-manage~     their disease.~      It is hypothesised that the establishment of the HBCP programme with regular monthly~     assessments of DM patients and disease management by the programme's HBCPs improves the~     patients' HbA1c levels, medication adherence, health-related quality of life, mental~     well-being, and health literacy levels. It is also hypothesised that patients will show~     further improvement when the HBCP programme is coupled with a mobile health application for~     patients that includes diaries, notifications and educational material. The aim of the study~     is to determine the efficacy of such an integrated programme for the management of DM in~     primary health care in Rwanda.~      Study design: The study is designed as a one-year, open-label cluster trial of two~     interventions (intervention 1: HBCP programme; intervention 2: HBCP programme + mobile health~     application) and usual care (control). In preparation for the onset of the study, a mobile~     application is being developed. Focus discussion groups will be carried out with selected~     patients and HBCPs after the end of the main trial to explore their opinions in participating~     in the study.~      Study population: District hospitals from those running the HBCP programme will be selected~     according to criteria. Under each district hospital, the administrative areas (cells)~     participating in the HBCP programme will be randomised to receive intervention 1 or 2. The~     patients from each group who meet the eligibility criteria of the study will receive the same~     intervention. Cells that do not participate in HBCP programme will be assigned to the control~     group.~      Study endpoints: The primary outcomes will be changes in HbA1c levels. Medication adherence,~     mortality, complications, health-related quality of life, mental well-being and health~     literacy will be assessed as secondary outcomes.~      Sponsor: The D²Rwanda project has received financial support by the Karen Elise Jensens Fond~     (Denmark), and the Universities of Aarhus and Luxembourg.~   "
14541|NCT03376594|"~     1. To compare the effectiveness of Benjakul extract capsules at 300 mg per day with~          Loratadine drug in the treatment of allergic rhinitis patients in small group (Clinical~          Trial Phase II).~        2. To study the safety and side effects of Benjakul extract capsules 300 mg per day and~          Loratadine drug for allergic rhinitis patients.~   "
14698|NCT03374553|"~     The study will evaluate the efficacy and safety of MINIject 636 and IOP lowering effects with~     or without glaucoma medications. The procedure will be a stand-alone surgery. Overall, the~     patient will be asked to perform several examinations up to 24 months after surgery.~      The primary efficacy objective of the present study is to show the IOP reduction under~     medication 6 months after surgery compared to medicated diurnal IOP at screening.~   "
14542|NCT03376581|"~     Platelet rich plasma (PRP) is an autologous preparation of human plasma with high~     concentration of platelets. Platelets release numerous growth factors, which stimulate cell~     proliferation and differentiation.~      The purpose of this research is to investigate the potential of PRP injection for treatment~     of hair loss. Clinical outcomes will be assessed by noninvasive techniques including~     dermoscopy, multiphoton microscopy, optical coherence tomography, optical Doppler tomography~     and multispectral imaging.~   "
14543|NCT03376568|"~     This study evaluates the PSG and cerebral metabolism and functions in narcolepsy with/without~     RBD~   "
14544|NCT03376555|"~     Increased dairy intake is associated with improved measures of blood vessel health. Dairy~     cheese, however, is often high in sodium. Dietary sodium can impair blood vessel function.~     The researchers examine if and how natural cheese may protect against impairments in blood~     vessel function caused by sodium. For this study, participants complete four 8-day controlled~     feeding periods in which they eat cheese (6 oz/day) or no cheese during a low-sodium or~     high-sodium base-diet. The participants complete baseline experiments while on their normal~     personal diet and then repeat experiments at the end of each controlled feeding period. In~     some of our experiments, the researchers use a technique called microdialysis (MD). With~     MD, the researchers perfuse some research drugs into the skin on the forearm through tiny~     tubing that mimics capillaries. These MD drugs mimic or block substances the body naturally~     makes to control the small blood vessels in the skin. The drugs remain in nickel-sized areas~     around the tubing and do not go into the rest of the body. The researchers also use a~     standard technique called flow mediated dilation (FMD) that uses blood pressure cuffs and~     ultrasound to look at the health of larger blood vessels in the body. FMD includes placing a~     small tablet of nitroglycerin under the tongue during part of the test.~   "
14545|NCT03376542|"~     This is a prospective cohort study of patients undergoing coronary artery bypass graft~     surgery. Prior to surgery, participants will undergo submaximal cardiopulmonary exercise~     testing on a treadmill. Participants will be followed for one month after surgery to assess~     mortality and non fatal complications.~   "
14546|NCT03376529|"~     This is a Phase 1, single-center, multi-arm, open-label, randomized, three-period, crossover~     study to evaluate the drug-drug interaction, pharmacokinetics, safety, and tolerability of a~     single dose of SPR741 combined with each of 3 different partner antibiotics (ceftazidime or~     piperacillin/tazobactam or aztreonam) in healthy volunteers. Participants will be~     administered single doses of SPR741 alone, a single dose of SPR741 in combination with 1 of 3~     different partner antibiotics, and the partner antibiotic alone in a randomized sequence.~     Twenty-seven (27) adult male and female normal healthy participants 18 to 55 years of age are~     planned to participate in the study. Women of childbearing potential will not be eligible to~     participate.~   "
14547|NCT03376516|"~     A prospective, non-controlled, international, multi-centre phase 3 study to investigate the~     pharmacokinetics, efficacy, safety, and immunogenicity of Wilate in previously treated~     children with severe haemophilia A~   "
14548|NCT03376503|"~     Breast cancer patients scheduled to receive myelosuppressive chemotherapy (AC regimen) will~     be enrolled in this study. Eligible patients receive single SC injection of pegcyte or~     neulastim 24 hours after administration of chemotherapy (Doxorubicin and Cyclophosphamide) in~     the first cycle (14 days each cycle). Blood samples are collected to determine the serum~     concentration of investigational drugs at specific time points in the first cycle. Absolute~     neutrophil count, CD34+ count, Cmax (maximum serum concentration), AUC0-t (area under the~     curve of the plasma concentration time) and Tmax (time required to reach Cmax) will be~     calculated from the serum concentration profile~   "
14549|NCT03376490|"~     Vitamin B12 deficiency can cause severe problems with the blood, nerves, brain and~     psychological well-being. Ironically, our modern methods for the control of diabetes mellitus~     can actually contribute to vitamin B12 deficiency. This is because the diabetic medication~     metformin, low-cholesterol diets lacking in meats (a natural source of vitamin B12) and the~     use of powerful anti-gastric medication can all reduce the natural absorption of vitamin B12~     from the diet, especially in elderly people with diabetes.~      There is both a high prevalence of vitamin B12 deficiencies and falls among the elderly with~     type 2 diabetes mellitus and the investigators hypothesize that B12 deficiency contributes~     directly and significantly to falls in elderly diabetics through impaired muscle strength,~     gait and balance.~      This study therefore proposes to investigate the association between vitamin B12 deficiency~     and fall risk among diabetic elderly patients (older than 65 years) in the polyclinic setting~     by assessing muscle strength, balance and walking speed. The predictors of vitamin B12,~     folate, homocysteine and vitamin D levels will also be explored in this study.~      If the hypothesis is right, this would be of public health importance & can lead to further~     studies that can change the way we treat diabetes by reducing falls in our elderly diabetics~     through the screening for, prevention and treatment of B12 deficiency.~   "
14550|NCT03376477|"~     The investigator's primary objective is to compare the 2-year progression free survival of~     patients treated with lenalidomide alone or in combination with vaccine~   "
14551|NCT03376464|"~     The goal of this study was to evaluate the efficacy and safety of two injection techniques in~     the management of masseteric hypertrophy using Xeomin Cosmetic.~   "
14552|NCT03376451|"~     EndoSearch aims to analytically validate a cluster of specific biomarkers for endometriosis~     diagnosis and disease recurrence. This signature will be tested on endometrium and blood from~     975 patients, divided in two groups : 550 patients affected by endometriosis and 225 patients~     unaffected (controls).~      EndoSearch is not about drug or medical device assessment but a research study for biomarker~     analytical validation purpose.~   "
14553|NCT03376438|"~     The FAST Trial Registry is a prospective observational cohort study of fetuses with a new~     diagnosis of atrial flutter (AF) or supraventricular tachycardia (SVT) that is severe enough~     to consider prenatal treatment (see eligibility criteria below). Aims of the Registry include~     to establish a large clinical database to determine and compare the efficacy and safety of~     different prenatal treatment strategies including observation without immediate treatment,~     transplacental antiarrhythmic fetal treatment and direct fetal treatment from the time of~     tachycardia diagnosis to death, neonatal hospital discharge or to a maximum of 30 days after~     birth.~   "
14557|NCT03376386|"~     Patients with primary head and neck squamous cell carcinoma (HNSCC) planned for treatment~     with radiotherapy with or without chemotherapy in curative setting will be treated with an~     adaptive radiotherapy scheme. An FDG-PET/CT scan for re-delineation and re-planning will be~     made at the end of the second and fourth of week of radiotherapy. The non-responding part of~     the tumor on FDG-PET will receive a mild dose-escalation. Depending on the metabolic~     response, the entire tumor will receive 70 Gy or the residual FDG-avid area will receive 74~     or 78 Gy.~   "
14558|NCT03376373|"~     Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder, more prevalent than~     previously thought and heterogeneous in expression, though uniformly characterized by severe~     social disability. The social disability that defines ASD pervades other areas of adaptive~     behavior, is predictive of secondary mental health problems, and adversely affects long-term~     outcome. Although ASD is a chronic condition, there has been little research on interventions~     for adults with ASD. This study proposes to first establish the neural plasticity of specific~     brain mechanisms underlying difficulties with facial emotion recognition, a core deficit~     believed to be pivotal in the behavioral expression of ASD-social disability. The~     investigators will then develop a novel, computer-based intervention using real-time~     feedback, to the user, to ameliorate emotion recognition deficits.~   "
14559|NCT03376360|"~     Prostate cancer is the most common cancer in men over 50 years old and the third leading~     cause of cancer death. Because of the variety of prostate cancers, different treatments~     exist.~      Several criteria guide this management in daily practice: PSA level; TNM stage (digital~     rectal examination, trans-rectal ultrasound and classical visual imaging) and pathological~     differentiation with the Gleason score, to which can be added other prognostic criteria:~     growth and doubling time of the serum PSA, number of positive biopsies and percentage of~     cancer lesions by biopsy.~      Functional imaging by PET and MRI is increasingly used in daily clinical practice to~     characterize prostate cancer, either during initial discovery or during recurrence. In this~     context, it is the qualitative visual analysis that is mainly used. Quantitative image~     analysis could add new criteria to guide patient management.~      Consequently, the objective of this study were:~        -  Optimization of 18F-choline PET/CT Acquisition in Prostate Cancer~        -  Comparison the quantitative parameters obtained by 18F-Choline PET / CT and both~          perfusion MRI and histological parameters.~   "
14560|NCT03376347|"~     Reducing intraoperative hypotension using FlotracIQ with HPI software.~   "
14561|NCT03376334|"~     This study intended to investigate the effect of imagining a movement task on dynamic balance~     of sedentary university students. Two groups with good mental imaging ability were studied;~     one group receiving instructions on mental imagery and the other served as a control~     receiving no particular intervention. Any improvement in the balance ability was measured~     using the star excursion balance test (SEBT); for it has good to excellent test-retest~     reliability and validity as established by several researchers.~   "
14562|NCT03376321|"~     The purpose of this study is to evaluate the clinical and virologic benefit of pimodivir in~     combination with Standard-of-Care (SOC) treatment compared to placebo in combination with SOC~     treatment.~   "
14563|NCT03376308|"~     During general anesthesia, intravenous (IV) medications can disrupt the patient's comfort by~     causing a pain sensation or a withdrawal response in the heart. Propofol and rocuronium are~     among the most common causes of this condition.~      In recent years, the use of ultrasonography (USG) in anesthesia has become widespread with~     the rapid advancement of technology. The use of the patient's head is a non invasive method.~      This study is aimed to evaluate whether the size of the venous diameter assessed by~     ultrasonography in our study is an effect on pain and withdrawal response after drug~     injections.~   "
14564|NCT03376295|"~     To assess the effectiveness of maintenance treatment of Chronic obstructive pulmonary disease~     (COPD) with the combination of a long-acting bronchodilators (LABA and the LAMA tiotropium~     (LABA-TIO)) compared with the combination of a LABA and an ICS (LABA-ICS) on the time to COPD~     exacerbation.~   "
14565|NCT03376282|"~     Diabetes kidney disease is a leading cause for end stage renal disease in the western world.~     To date no treatment that can reverse renal damage exists.~      Chronic hypoxia is one of the major key insults affecting the diabetic kidney, and many of~     the new treatments under study focus on it's consequences, but no treatment can improve the~     hypoxia as both increased renal perfusion and decreased renal perfusion may be associated~     with it's worsening. Hyperbaric oxygen therapy (HBOT) can improve renal hypoxia by increasing~     partial pressure of dissolved (non-hemoglobin-bound) oxygen without affecting it's demand.~     HBOT also recruits tissue and peripheral progenitors and supplies the optimal environment~     crucial for their proliferation and for tissue repair. Hyperbaric oxygen treatment was known~     for years as an effective treatment for diabetic ulcers. Recent trials have shown great~     impact on brain lesions (in diabetic and non-diabetic patients) it is now the time to~     evaluate the effect of HBOT on the diabetic kidney.~   "
14566|NCT03376269|"~     The aim of the study is to evaluate the effect of hyperbaric oxygen therapy (HBOT) on 2 types~     of patients' population suffering from chronic pain syndrome (Fibromyalgia): patients with~     history of psychological trauma and patients with history of traumatic brain injury.~   "
14567|NCT03376256|"~     The purpose of this pilot study is to evaluate whether the Compuflo Epidural Instrument~     injection pump technology, which is FDA approved for lumbar epidural anesthesia, is also~     capable of identifying the thoracic epidural space through measurement of pressure levels.~     While this device is approved by the FDA for use in the procedure of the lumbar epidural, it~     is not used to perform the epidural procedure but rather to measure the epidural pressure.~     This study will likewise measure the epidural pressure.~   "
14568|NCT03376243|"~     The aim of this pragmatic, parallel group, assessor-blind randomised open-label prospective~     study is to determine the reasons that motivate parents to enrol or not enrol their child in~     a randomized, controlled basic emollient trial for the prevention of atopic eczema (AE).~     Furthermore, this trial intends to test the hypothesis that daily skin barrier enhancement~     with Lipikar Baume AP+® in newborns at high risk is safe and efficient in preventing AE.~      T~   "
14811|NCT03373071|"~     The primary objective of this phase I study is to evaluate the safety and to establish the~     recommended dose of CD19-CART01 infused in pediatric patients affected by relapsed/refractory~     B-ALL or NHL with measurable Bone Marrow (BM) involvement. The phase II extension is aimed at~     testing the efficacy of the treatment at the optimal dose defined in the phase I.~   "
14569|NCT03376230|"~     Inflammatory Bowel Diseases (IBD) including Crohn's disease and ulcerative colitis are~     multifactorial diseases leading to chronic inflammation of intestinal mucosa. Their etiology~     is still unknown. Recently, major advances in the understanding of their pathophysiology have~     allowed to define them as heterogenic polygenic diseases, occurring in genetically~     susceptible patients. However, the whole genetic susceptibility does not explain the~     development of IBD and several data argue in favor of the involvement of environmental~     factors, which remain to be identified.~      The aims of this clinical trial are:~        1. As main objective: To determine the effects of environmental pollutants on intestinal~          homeostasis and particularly on inflammatory process and endoplasmic reticulum stress.~        2. As secondary objective, to assess in human the genetic susceptibility of intestinal~          mucosa to environmental chemical compounds (I.e. xenobiotics), its interindividual~          variability, and its potential involvement in the pathogenesis of IBD.~   "
14570|NCT03376217|"~     The overall aim of the study is to learn whether utilization of Health Surveillance~     Assistants (HSAs) for delivery of intermittent preventive treatment of malaria in pregnant~     women (IPTp) can increase coverage of three or more IPTp doses compared to IPTp delivery only~     at antenatal clinics (ANC), while at the same time improve or maintain ANC attendance. This~     will be a cluster randomized trial, including a total of 20 health facilities (HF) which will~     be randomly assigned to either the intervention (10) or non-intervention group (10); all HSAs~     affiliated with a HF will be in the same group.~   "
14571|NCT03376204|"~     Pain mechanisms and their clinical impact in patients with bronchiectasis have not been~     investigated yet. The aim of the research is to assess the presence of central pain~     mechanisms in patients with bronchiectasis using the Quantitative Sensory Testing (QST)~     assumptions.~   "
14572|NCT03376191|"~     To explore the efficacy and safety of apatinib in non-squamous non-small cell lung cancer in~     the real-world.~   "
14573|NCT03376178|"~     Multiorifice catheters have been shown to provide superior analgesia and significantly reduce~     local anesthetic consumption compared with end-hole catheters in epidural studies. This~     prospective, blinded, randomized study tested the hypothesis that, in continuous femoral~     nerve block (CFNB) under ultrasound guidance, multiorifice catheter would reduce local~     anesthetic consumption at 24h compared with end-hole catheter.~   "
14574|NCT03376165|"~     To explore predictors of major cardio-vascular events after cardiac surgery and~     trans-catheter valve implantation with a specific interest in studying mechanisms linking~     pre-operative leukocyte, fat and myocardial phenotypes with post-intervention outcomes.~   "
14575|NCT03376152|"~     This study will evaluate the impact of a pilot Rural Electric Kettle Promotion Program~     offered to low-income households in rural Anhui Province, China. The primary objective of~     this study is to determine whether this promotion program causes poverty households currently~     boiling their drinking water with solid-fuels (or drinking untreated water or bottled water)~     to switch to boiling their drinking water with electric kettles, and if so, how such a switch~     might improve safe drinking water access and/or reduce household air pollution.~   "
14576|NCT03376139|"~     The objective of this study is to determine if, compared to placebo, zonisamide (400mg/day)~     is a safe and efficacious treatment for post-traumatic stress disorder (PTSD) and alcohol use~     disorder (AUD) in Veterans with PTSD and co-occurring AUD.~   "
14577|NCT03376126|"~     The aim is to analyse feasibility of a minimally-invasive isolated limb perfusion.~   "
14578|NCT03376113|"~     Recent research has focused on examining brief interventions for reducing self-harm, such as~     the volitional help sheet (VHS). The VHS is a theory-based psychological intervention. Two~     previous studies applying this tool for reducing self-harm repetition showed inconsistent~     results; one showed reduced subsequent self-reported suicidal ideation and behavior in~     patients presenting to hospital for self-harm, whilst the other showed no effect on the~     number of patients who re-presented to hospital with self-harm. The aim of this study is to~     investigate the feasibility of the VHS intervention amongst self-harm patients in Taiwan and~     explore its effect on self-harm repetition based on self-reported self-harm, hospital~     re-presentations with self-harm, and self-harm episodes from a nationwide self-harm registry.~     It is a two-phase study: first a qualitative study and second an exploratory randomized~     control trial. The first study is to interview people who self-harm about their perceptions~     about the VHS on the online platform, to inform the modification of VHS and the best way to~     intervene. The second is to examine the feasibility and effect of this intervention at the~     emergency department setting.~   "
14579|NCT03376100|"~     Randomized controlled trial comparing the standard haematoma block used for reduction of~     distal forearm fractures in the Emergency Department with ultrasound guided nerveblocks. The~     investigators hypothesize that ultrasound guided blocking of the radial and median nerves~     will improve fracture reduction satisfaction for the true Colles' fractures and improve~     analgesia for reduction of all distal forearm fracture types compared to the standard~     haematoma block.~   "
14580|NCT03376087|"~     Seizure-related cardiac arrhythmias are one of the possible causes of sudden unexpected death~     in epilepsy (SUDEP). Identification of these patients is challenging because cardiac rhythm~     disturbances could emerge only during seizures. Furthermore, patients could have transitioned~     sinus or AV node blocks which could cause syncopes with brady-related seizures which could be~     treated as epilepsy-related seizures. Implantable loop recorders have an ability to recording~     single-channel ECG for up to 36 months which give an ability to detect these heart~     disturbances.~      The purpose of this study is to look the incidence and types of arrhythmias which occur in~     150 patients with hard-to-treat partial seizures and secondarily generalized seizures~   "
14581|NCT03376074|"~     Interest of oxygenated hypothermic perfusion in preservation of hepatic grafts from expanded~     criteria donors.~   "
14582|NCT03376061|"~     The aim is to conduct a double-blinded single-centre randomized controlled clinical trial of~     application of topical dose of tranexamic acid (TA) versus the usual intravenous TA in~     patients undergoing cardiac surgery at the Hamilton General Hospital. This pilot study will~     assess the feasibility to perform a large randomized international trial exploring this~     objective.~   "
14583|NCT03376048|"~     The TAP block is typically performed either with ultrasound guidance (TAP-US) or laparoscopic~     visualization (TAP-LAP): comparison between these two technics showed no differences in pain~     control and use of opioid analgesics.~      The investigators hypothesize that WI is non-inferior to WI + TAP-block with respect to~     postoperative pain.~   "
14585|NCT03376022|"~     Oral Health care has been shown to have low priority among nursing personnel, especially~     among personnel with shorter education. As the population gets older and keep their natural~     teeth high up in age, in most cases throughout life, it is of importance to help the older~     maintain a good oral health when the cognitive functions and physical ability decreases. In~     1999, a new dental care system was introduced with the aim to offer elderly with long-term~     need for extensive care, home visits for oral health assessment and, if necessary, be offered~     the necessary dental care. The aim was also to offer nursing personnel education and training~     in dental health and oral care, in order to provide and perform oral care. The effect of the~     education program has never been evaluated.~   "
14586|NCT03376009|"~     Kidney dysfunction before and immediately after liver transplantation is common and leads to~     poorer outcomes, including prolonged need for post-operative intensive care, diminished graft~     survival, and greater risk of permanent kidney dysfunction and death. Blood creatinine level~     - the standard measure of kidney function - is suboptimal in people with advanced liver~     disease, overestimating kidney function by >20%. There is significant concern that liver~     transplant recipients are at higher risk of acute kidney injury (AKI) than we can currently~     predict. This study aims to identify superior tests (blood/urine or imaging) for kidney~     dysfunction, to enable improved treatment and patient outcomes.~      This study aims to recruit 80-100 consecutive patients admitted to the Scottish Liver~     Transplant Unit (SLTU), Royal Infirmary of Edinburgh (RIE) for liver transplant assessment~     over a 6 month period. Permission will be sought to record the results of routine tests~     performed by the NHS during this assessment week. These tests include: electrocardiograph~     (ECG), Computed Tomography (CT) liver and abdomen, cardio-pulmonary exercise testing (CPEX),~     pulmonary function tests (PFTS), routine haematology and biochemistry blood tests, 24 hour~     urine collection and body composition analysis.~      In addition, we will invite participants to attend the RIE clinical research facility (CRF)~     for a single visit (~2 hours) to perform extra research assessments. Blood and urine will be~     collected for biomarker analysis. Non-invasive assessment of cardiovascular function will be~     completed using cardiac bio-impedance and aortic pulse wave velocity. Examination of the~     blood vessels at the back of the eye will be performed using optical coherence tomography.~      A subgroup of 10 participants will undergo magnetic resonance imaging (MRI) of the kidneys~     using arterial spin labelling to identify dysregulated renal perfusion. Patients who are~     transplanted during the study timeframe will be asked to re-attend the CRF for repeat~     assessments at 6 weeks post transplantation.~      Funded by Scottish Liver Transplant Unit Endowment Fund~   "
14587|NCT03375996|"~     Laser-assisted cataract surgery is an innovative and growing procedure to improve the safety~     and results of modern cataract surgery. However, this technique faces to some obstacles:~     economics in the one hand due to the cost and time spent for the laser procedure before the~     conventional surgery, and technical in the other hand, especially due to some loss of pupil~     dilation during the surgery, which is highly important to ensure a perfect procedure. The~     present study aims at assessing a pharmacological protocol to maintain an accurate pupil~     dilation all along the surgery in order to improve the whole procedure.~   "
14588|NCT03375983|"~     The purpose of this study is to evaluate the safety of Plasmodium immunotherapy and~     preliminarily evaluate the effectiveness of Plasmodium immunotherapy for advanced cancers.The~     treatment will last 3-6 months from the day of successful infection and will be terminated by~     antimalarial drugs.~   "
14589|NCT03375970|"~     In Taiwan, there are many patients suffer from pediatric atopic dermatitis. Because of the~     clinical characteristic of repetitive and scratchy, which will affect the patients' quality~     of life and lead to the medical heavy budget. TCM may play an important role in this disease~     and help patient to improved their health. In this project, we aim to establish a~     Collaborative Care Model of TCM and Western Medicine, to achieve the multiple goal in~     clinical treatment, research and medical training. By establishing a collaborative care~     model, including the Chinese medicine doctor and Western medicine doctor, nurses, pharmacists~     and case managers, to cooperative satisfy the patient needed in the medical service, to~     improve the clinical presentation, patients'quality of life, and reduce exposure to~     corticosteroid. Besides, we can also build a training environment and reduce medical cost in~     long term purpose. Furthermore, by establishing a collaborative care model, we can provide a~     medical education and training opportunity to educate the medical student and clinician the~     necessary knowledge of pediatric atopic dermatitis by caring patients and learning from~     clinical case. According to the above training program, we not only aim to strengthen the~     competitiveness of Chinese medicine doctor in Taiwan, but also make the Western medicine~     doctors comprehend the TCM characteristic and may find out the even more opportunity to~     cooperate in clinical practice. To make this collaborative care model as a beginning~     milestone of cooperation between Chinese medicine and Western medicine.~   "
14590|NCT03375957|"~     This is a Phase I, single-site study to evaluate the sensitization potential of topically~     applied ATx201 GEL, 2% and 4%, along with a placebo control, in healthy human subjects.~   "
14591|NCT03375944|"~     Although clinical data demonstrate advantages of combining complete revascularization with~     optimal cardiac rehabilitation (CR) less than one-third of patients in European countries~     participate in cardiac rehabilitation programs. Therefore, in cooperation with Polish leaders~     in cardiovascular medicine, rehabilitation and medical software design we aim to introduce~     and evaluate the system of optimal cardiac telerehabilitation in addition to optimal~     treatment of coronary artery disease.~   "
14592|NCT03375931|"~     physiological end-point, incidence of adverse events, and changes in psychological status.~      In the past, physiological goals, major morbidity and mortality were used as indicators of~     recovery after surgery. However, major morbidity and mortality rates were extremely low due~     to the development of surgery and anesthesia techniques, and measurements of these indicators~     do not adequately reflect postoperative recovery. On the other hand, the measurement of the~     patient's health status or quality of life has become an important metric in many clinical~     studies. The Quality of Recovery 40 Questionnaire (QoR-40) is a multidimensional tool that~     specifically assesses and develops anesthetic and postoperative health conditions. Severance~     Hospital is conducting an anesthesiologist-led prayer for the patient only for the desired~     patient before anesthesia. Although it may be expected that this preoperative airway may~     improve the quality of recovery after anesthesia / surgery by reducing patient anxiety, there~     is no objective study on this. The aim of this study was to investigate the effect of~     preoperative preoperative airway on the quality of postoperative recovery in patients who~     underwent thyroidectomy for thyroid cancer. I want to see. In addition, we will investigate~     whether preoperative airway affects sympathetic nervous system during surgery.~   "
14812|NCT03373058|"~     This project is a multi-center, prospective, randomized controlled clinical observation the~     safety and efficacy of hyperthermic intraperitoneal chemotherapy in the treatment of~     advanced-stage epithelial ovarian cancer after cytoreductive surgery. 3-year disease-free~     survival is the primary end points of this project.~   "
14593|NCT03375918|"~     The goal of CONSULT-BP is to train early-stage healthcare providers, including residents and~     nurse practitioner (NP) students, to mitigate providers' bias, improve communication skills,~     and enhance providers' ability to develop authentic and meaningful therapeutic alliances with~     patients. The study setting is an academic safety net hospital that serves a large non-White~     and poor population. We hypothesize that patients' outcomes (blood pressure levels) will be~     lower after the training intervention compared with before training (control) periods.~   "
14594|NCT03375905|"~     The aim of this study is to evaluate the effectiveness and safety of cNEP (continuous~     negative external pressure) for the treatment of obstructive sleep apnea during two weeks of~     home use in subjects of Japanese ethnicity.~   "
14595|NCT03375892|"~     This study aims to discover more about radiation techniques for people treated for left-sided~     breast cancer that minimizes exposure to the heart, as noted by mean heart dose.~   "
14596|NCT03375879|"~     This study is being conducted to determine whether the use of bandage contact lens after~     ptosis surgery provides any benefits for the patient or is unnecessary.~   "
14597|NCT03375866|"~     The first goal of the proposed study is to determine acute and long-term effects of mixed~     nuts (almonds, hazelnuts, pecans, pistachios, walnuts, and peanuts) on metabolic parameters~     and weight management. While numerous studies have shown the beneficial effects of nuts on~     promoting negative energy balance and weight loss, mechanistic studies exploring how the~     inclusion of nuts in the diet promotes a negative energy balance and weight loss have not~     been conducted. The second goal is to determine the mechanisms by which mixed nut consumption~     regulates of food intake and body weight.~   "
14598|NCT03375853|"~     This project will test whether a food response training intervention produces lasting body~     fat loss, use objective brain imaging to examine the mechanism of effect of this treatment~     and investigate the generalizability of the training to non-training foods, and examine~     factors that should amplify intervention effects to provide a test of the intervention~     theory. This novel treatment represents a bottom-up implicit training intervention that does~     not rely on executive control, prolonged caloric deprivation, and expensive clinicians to~     deliver, like behavioral weight loss treatments that have not produced lasting weight loss.~     If this computer-based response training intervention produces sustained body fat loss in~     overweight individuals, it could be easily implemented very broadly at almost no expense,~     addressing a leading public health problem.~   "
14599|NCT03375840|"~     Pictorial cigarette warning labels (PWLs) are thought to increase risk knowledge, but~     experimental research has not examined PWLs' longer term effects on memory for health risks.~     This trial tests memory for health risks immediately or after a six-week delay for~     US-representative adult smokers, US-representative teen smokers/vulnerable smokers, and~     Appalachian-representative adult smokers. In addition, the trial tests the effects of~     different warning label components and the consequences of memory for labels on risk~     perceptions and quit intentions.~   "
14600|NCT03375827|"~     This research study is evaluating whether asking patients to fill out a brief survey about~     their goals and preferences for care and giving this survey to their clinician before the~     next visit helps improve communication and decision-making in breast cancer care.~   "
14601|NCT03375814|"~     The effect of Crocina on the production of IL-4, IL-1 bet, IL-17, IL-10 and TGF-beta: The~     effect of crocina on gene expression of transcription factors T-bet, GATA-3. FOXP3, ROR-γt,;~     The effect of helper T cells type one and two, regulatory T cells and T helper type 17 cells;~     the effect of crocina on the reduction of pain and joint inflammation. Design: Randomized,~     Double-blind and Placebo controlled; Study population: Patients with Osteoarthritis; Volume:~     40 persons; Method: Osteoarthritis patients will be divided into two groups according to age~     and sex; Crocina tablets will be prescribed to the first group a tablet 15 mg daily along~     with conventional Medicines; Placebo tablets will be prescribed to the second group along~     with the conventional medicines; Blood sampling of patients will be done before drug~     administering and four months after treatment. Major Inclusion Criteria: Osteoarthritis~     patients with age 40-75 years; The severity of joint damage between grade 2 and 3; Patients~     without history of injury; Patients with body mass index less than 30. Major Exclusion~     Criteria: Osteoarthritis patients with age 40-75 years; The severity of joint damage in grade~     one and four; Patients with history of injury and body mass index 30 or more. Intervention:~     Treatment with prescription of drug at dose of 15 mg daily crocin in the study group and~     placebo in the control group. Time: 4 months; Main outcome Measures: Osteoarthritis, Pain,~     Inflammation, Crocina, IL-4, IL-1 beta, IL-17, IL-10, TGF- beta, Cell surface protein CD127,~     The expression of T-bet, GATA-3, FOXP3, ROR-γt and the number of Th1, Th2, T-regulatory and~     Th17.~   "
14602|NCT03375801|"~     This is a pre-and post intervention study on the effect and implementation of an personalized~     decision aid for woman with breast cancer who face a decision on their radiation treatment.~   "
14603|NCT03375788|"~     Nonalcoholic fatty liver disease (NAFLD) is common in individuals with obesity and is a~     significant threat to public health, because it can lead to impaired liver function and liver~     failure. Growth hormone is a hormone produced in the pituitary gland that helps regulate~     metabolism and growth. Individuals with obesity, on average, secrete less growth hormone than~     individuals without obesity. There are data to suggest that growth hormone may help to reduce~     the amount of fat in the liver, and may also reduce inflammation in the liver, both of which~     would be helpful to individuals with NAFLD. The purpose of this study is to investigate~     whether treatment with a drug called tesamorelin, which is a growth hormone releasing hormone~     analogue, will decrease liver fat and improve liver inflammation and scarring in obese~     individuals with NAFLD.~   "
14604|NCT03375775|"~     The objective is to prospectively explore associations between immunological parameters in~     blood and clinical effect of subcutaneous immunotherapy (SCIT) in children with severe~     allergy towards pollen. Half of the children will receive SCIT while the other half will~     start SCIT after the study is finished. Clinical evaluations of symptoms and an immunological~     survey will be performed before start of SCIT and after one year of treatment. Some of the~     immunological parameters will also be checked after 6 months of treatment~   "
14854|NCT03372499|"~     Hepatic encephalopathy is a severe complication of transjugular intrahepatic portosystemic~     shunt (TIPS) treatment in patients with cirrhosis and variceal bleeding. This study is~     specially designed to explore whether diet management strategy could decrease incidence of~     encephalopathy after TIPS treatment.~   "
14605|NCT03375762|"~     Stroke is one of the leading causes of death worldwide and the main cause of incapacity.~     Currently, the only therapies for acute ischemic stroke (AIS) patients are the administration~     of recombinant tissue plasminogen activator (rt-PA) and/or endovascular treatment.~     Unfortunately, many patients cannot benefit from these therapies due to contraindications or~     evolution time. Neuroprotective therapies could not only increase the benefits of available~     reperfusion therapies but also provide an option for patients who are not candidates for~     these treatments. Remote ischemic conditioning, consisting on brief episodes of transient~     limb ischemia, represents a new paradigm in neuroprotection. It can be categorized in pre-,~     per- or postconditioning, depending on the moment of application. According to studies in~     coronary ischemia, remote ischemic perconditioning (RIPerC) during the ischemic event is~     safe, cost-effective, feasible and associated with a reduction in myocardial injury. The~     investigators aim to conduct a multicentre study (5 university hospitals) of pre-hospital~     RIPerC in AIS patients (within 8 hours of stroke onset), which would include 572 stroke code~     activated patients (286 would undergo RIPerC and 286 would be sham). Our hypothesis is that~     RIPerC would be safe and would induce endogenous neuroprotective phenomena associated with~     good outcomes in AIS patients whether treated with revascularization therapies or not.~     Moreover, the development of systemic ischemic tolerance should provide metabolomic and~     lipidomic signatures that would present an opportunity to find specific molecular markers~     (biomarkers). The main objectives will be to assess: 1) RIPerC clinical benefits in AIS, 2)~     whether RIPerC is safe not only in AIS but also in all cases of stroke code activation, 3)~     whether RIPerC is associated with a reduction in cerebral infarct size and 4) metabolomic and~     lipidomic signatures of the RIPerC effect.~   "
14606|NCT03375749|"~     Research indicates that sedentary behaviours, such as prolonged sitting, have negative health~     consequences and increases risk for disease. Unfortunately, many office-workers spend a high~     proportion of their workday sitting, often in prolonged unbroken bouts. Recent interventions~     have provided active workstations (e.g., sit-stand desks) to reduce employee sitting.~     However, cost prohibits provision of these desks in work environments. There is a need for~     low-cost solutions to reduce sitting at work. The purpose of this study is to determine~     whether provision of a low-cost standing desk reduces workplace sitting, and results in~     improvements in work engagement and fatigue, compared to usual practice.~   "
14607|NCT03375736|"~     Osteopenia is common in children with cerebral palsy (CP) due to poor bone growth and muscle~     disuse and the problem extends to their adulthood. These children and young adults with CP,~     especially those with moderate physical disabilities, are unable to perform the required~     amount of exercise to improve their bone health as their typically developing counterparts.~     As a result, non-traumatic fractures and bone pain are common in individuals with moderate~     severity of CP. Whole body vibration therapy (WBVT) has been recently proven to improve bone~     health and muscle function in healthy adults and post-menopausal women. Among the research of~     the WBVT for children with CP, promising results have been shown on gross motor function,~     balance and muscle strength for children with mild disability. Among these published studies,~     the vibration protocols required the study participants to perform simple exercises on the~     vibration platform. Very limited studies have been conducted on children and young adults~     with moderate CP. At present, it is unknown if the effect of WBVT would be for this~     population group when compared with those with mild CP in terms of their gross motor function~     and balance, because the moderate group is greatly compromised in their mobility and extent~     of regular exercises when compared with the normal population and those with mild CP. In~     addition, it is unknown if static standing on the vibration platform would have similar~     effects on the gross motor function as doing simple exercises on the vibration platform. This~     pilot study aims to examine the effect of WBVT on children and young adults with moderate~     severity of CP. A convenience sample of 5 pre-puberty children aged between 6 to 14 years and~     5 young adults aged between 18 to 40 years with moderate CP, i.e. Gross Motor Function~     Classification System, GMFCS level III or IV, will be recruited to systematically investigate~     the effects of WBVT on their functional abilities.~   "
14608|NCT03375723|"~     Acute pulmonary embolism (PE) is a serious disease and the third most common cardiovascular~     disease following myocardial infarction and stroke. The most common symptoms of acute PE are~     breathlessness and respiratory pain. Although many patients have respiratory pain in acute~     PE, the treatment of pain is not well described in literature. It is also unclear how long~     after acute PE the respiratory pain persists. In other conditions with respiratory associated~     pain, clinical treatment guidelines are available to avoid complications, such as pneumonia,~     related to impaired respiratory function.~      The purpose of this randomized controlled multicenter study is to evaluate the effect of a~     treatment, in patients with respiratory associated acute PE pain, consisting of information~     on anatomy and physiology in acute PE and breathing technique in addition to usual care~     treatment. The above treatment will be compared to conventional treatment in PE with~     respiratory associated pain, which means treatment with analgesics.~      One hundred sixty patients recruited from the Sahlgrenska University Hospital and Alingsås~     Hospital will participate in the study.~      Both groups are examined before and after interventions related to respiratory associated~     pain, measured with visual analogue scale (VAS), analgesic consumption, lung function~     measured with Peak Expiratory Flow (PEF), physical disability impairment measured by~     Disability Rating Index (DRI) and questions about the patients self-efficacy on managing~     their respiratory associated pain, days hospitalized, pneumonia rate during or after~     hospitalization, oxygen saturation and patient satisfaction.~      Both groups are followed from the inclusion date to 14 days after inclusion through physical~     visits by the physiotherapist during hospital care and by telephone contact after discharge.~      If the positive clinical experience of the information and breathing technique can be~     confirmed in the study, the method could be spread and used as an easily accessible new~     treatment method.~   "
14609|NCT03375710|"~     This is a prospective, multi-center, open-label, single-arm feasibility trial to assess~     device safety and efficacy of the Cordella™ Heart Failure System in 10 NYHA Class III heart~     failure patients who will receive the Cordella™ Sensor implant.~   "
14610|NCT03375697|"~     The purpose of this study is to assess the safety and tolerability of JNJ-63733657 following~     single ascending intravenous (IV) dose administration in healthy subjects (Part 1) and~     multiple ascending IV dose administrations in subjects with prodromal or mild Alzheimer's~     disease (AD) (Part 2).~   "
14611|NCT03375684|"~     It is extensively reported in the literature that patients with chronic obstructive lung~     disease may have impairments in balance and postural control which further increase the~     disease burden. Mechanisms related to these impairments include, but are not limited to~     increased work of breathing, diaphragm weakness, peripheral muscle weakness and systemic~     inflammation. Since the similar symptoms are reported for the children with cystic fibrosis,~     it is hypothesized that balance and postural control may also be compromised in these~     patients. Inspiratory muscle training (IMT) is shown to improve diaphragm strength and~     pulmonary function. Considering the relation between diaphragm which is one of the core~     muscles, and balance, IMT may also have an impact on postural control and balance alongside~     the standard clinical parameters such as respiratory muscle strength, pulmonary function and~     functional capacity in these patients. Thus, the aim of this study was to investigate the~     effects of inspiratory muscle training and conventional chest physiotherapy on postural~     stability, balance, pulmonary function and functional capacity in children with cystic~     fibrosis.~   "
14612|NCT03375671|"~     Compare intramuscular (IM) ketamine to a combination of IM midazolam and haloperidol with~     regards to the time required for adequate behavioral control, in minutes, in patients~     presenting to the emergency department with psychomotor agitation and violent behavior.~   "
14699|NCT03374540|"~     The overall goal of this study is to evaluate the comparative safety and effectiveness of~     rivaroxaban vs. vitamin K antagonist (VKA) for stroke prevention in patients with nonvalvular~     atrial fibrillation (NVAF) across risk profiles and comorbidities that reflect everyday~     clinical practice.~      The primary objective in this study is to evaluate the combined end point of stroke or~     systemic embolism (SSE), and major bleeding in NVAF patients treated with rivaroxaban vs.~     VKA.~   "
14613|NCT03375658|"~     The overall goal of the project is to reduce the number of unexpected patient deteriorations~     by 50% at Emergency Departments (ED) by investigating if the novel Patient Deterioration~     Warning Systems (PDWS), can improve clinicians' ability to identify deterioration at an~     earlier stage.~      A third of all acute medical patients with normal vital signs at arrival, experience a~     deterioration in vital signs during the 24 first hours. This can potentially lead to dire~     consequences for these patients, as the risk of deterioration is present across all severity~     levels. The utilization of patient monitoring systems in the dispersed and shared working~     environments of EDs and acute wards may help to identify some of the reasons for failure to~     rescue patients. Thus, quantifying the extent to which a patient is being monitored, may be~     an aid to bridge the current gap between usage of automated and manual monitoring as clinical~     work will continue to depend on tacit knowledge and intuition.~      Several systems and protocols have been established to swiftly deal with identified~     deterioration. Most systems struggle with issues of clinical adherence and are difficult to~     assess on-the-fly, and in some cases nurses failed to notice abnormality in 43% of patients~     experiencing deterioration. Although the trajectories of patients' vital signs have been~     identified as more important than the initial scoring value, most of the widely used Track~     and Trigger systems lack a temporal aspect. Furthermore, a limited number of these Track and~     Trigger systems have been integrated into real time clinical decision support systems, which~     has not evolved much in the last decades.~      The PDWS deals with these challenges by aggregating and summarizing all vital values measured~     with the ED's patient monitors in the ongoing admission to intuitively present the state and~     trajectory. The investigators intend to determine if making the PDWS system available to~     nurses and physicians throughout the entire ED improves their ability to identify patients at~     risk of deterioration. To make this assessment, the PDWS will be evaluated in a cluster~     randomized trial (CRT) at two ED facilities in Denmark. The CRT is structured in three 5-week~     intervention, and three 5-week control periods, separated by a washout period of at least one~     week. The primary outcome is in-hospital deterioration - defined as transfer to the intensive~     care unit, heart/respiratory failure or death. The effect the PDWS will be assessed by~     comparing the proportions of events in each study arm using Pearsons's chi-squared test on~     these two samples. Furthermore, the technical and economical effects are evaluated using the~     Technology Acceptance Model, and the Model for Assessment of Telemedicine.~   "
14614|NCT03375645|"~     This study will determine pain and opioid outcomes 3 & 6 months after an emergency department~     visit for acute pain. This is an observational study. Patients are enrolled during an ED~     visit and followed by telephone 3 & 6 months later. Opioid databases will also be reviewed.~   "
14615|NCT03375632|"~     To investigate the pharmacodynamics and safety of FYU-981 administered orally once a day for~     14 weeks, to uric acid-overproduction type or uric acid-underexcretion type of male~     hyperuricemic outpatients with or without gout.~   "
14616|NCT03375619|"~     This protocol is designed as a long-term follow-up study of patients who will receive~     genetically modified autologous CAR-T cells as part of clinical trial at the Medical College~     of Wisconsin/ Froedtert Hospital-- Phase 1 Study of CAR-20/19-T Cells in Patients with~     Relapsed Refractory B Cell Malignancies.~   "
14617|NCT03375606|"~     To assess the safety and tolerability of ascending doses of CSL730 after a single intravenous~     (IV) infusion in healthy Caucasian and Japanese subjects~   "
14618|NCT03375593|"~     The purpose of this study is to evaluate two drug options for pain control in patients~     following wrist injury. Participants will be randomized to one of the 2 pain relief~     treatments to determine what treatment provides the most effective pain relief~   "
14619|NCT03375580|"~     This is a randomised clinical trial which aims to evaluate the efficacy of Compound Zhenzhu~     Tiaozhi capsules in the treatment of NAFLD and analyze the relationship between improvement~     in NAFLD parameters and changes in intestinal functions.~   "
14620|NCT03375567|"~     The primary objective of this study is to compare the detection rate of residual/refractory~     disease based on standard bone marrow biopsy versus guided myeloma lesion biopsy after~     induction therapy with carfilzomib, lenalidomide and dexamethasone regimen.~   "
14621|NCT03375554|"~     The goal of this prospective observational study is to investigate the effect on esophageal~     stethoscope insertion on tracheal cuff pressure during general anesthesia.~   "
14622|NCT03375541|"~     The investigators seek to determine if the use of a Side Effect Aversion Calculator helps~     patients with multiple sclerosis (MS) more comfortably and rapidly identify the disease~     modifying drug (DMD) that is best suited for the patient.~   "
14623|NCT03375528|"~     If intimal growth is such that the initial lumen is narrowed significantly, distal blood flow~     is restricted and chronic tissue ischemia results. This occurs in native coronary arteries~     and during restenosis after coronary angioplasty or failure of some coronary vein grafts.~     Stent implantation has become the principal revascularization technique for coronary artery~     disease. But, in-stent restenosis (ISR) by neointimal hyperplasia persists as a significant~     limitation of this procedure in the era of drug eluting stent (DES). Coronary intervention~     might induce an inflammatory response by arterial wall damage, release of inflammatory and~     chemoattractant factors resulting in leukocyte and platelet activation. Then, Migration and~     proliferation of neointimal smooth muscle cells together with the deposition of extracellular~     matrix might lead to the development of ISR.~      It is known that matrix metalloproteinases (MMPs) play a key role in the pathogenesis of~     restenosis by controlling extracellular matrix degradation and the release of~     matrix-degrading MMPs, including MMP -2 and MMP-9, which facilitate intimal remodeling after~     angioplasty. Previous studies showed that increased levels of MMPs in coronary arteries~     undergoing percutaneous intervention may be associated with vascular remodeling and~     restenosis by promoting migration of vascular smooth muscle cells. Recently, Gregory et al.~     demonstrated that elevated serum activities of MMP-2 and -9 are associated with dramatically~     increased restenosis rates after PCI with implantation of DES.~      In patients with DESs, determination of MMP levels might be useful for identification of~     patients who are at high risk for ISR. However, not much is known about the relationship~     between MMPs and neointimal hyperplasia in patients with DES. In this study, the serum~     activity of MMP-2 and 9 were investigated in patients who had undergone follow-up coronary~     angiography with intravascular ultrasound (IVUS), which performed at 9 months post-DES~     implantation. Our aim was to evaluate if individual or combined levels of MMPs were~     associated with increased neointimal hyperplasia volume, that is, to evaluate the~     relationship, correlation between the levels of MMPs and neointimal hyperplasia volume.~   "
14624|NCT03375515|"~     A large number of studies have shown that patients feel more satisfied with hydromorphone in~     the pain management. and a systematic review found that hydromorphone may be better suited~     than morphine for titration of acute analgesia. However, current researches on intraveneous~     opioid titration for cancer pain such as hydromorphone are relatively insufficient in China.~     Therefore, we conduct a prospective, multi-center, randomized controlled study to assess the~     efficacy and safety of comparing patient-controlled analgesia (PCA) versus non-PCA~     intravenous hydromorphone titration for severe cancer pain~   "
14625|NCT03375502|"~     To assess the safety of MG1111 and to evaluate immunological non-inferiority of MG1111 versus~     comparator~   "
14626|NCT03375489|"~     This research study is evaluating ways to provide palliative care to patients who have~     recently been diagnosed with lung cancer and their families.~   "
14627|NCT03375476|"~     This study evaluates the preoperative cardiovascular risk, the intraoperative hemodynamic~     characteristics and the surgical photo-plethysmographic index of patients undergoing general~     anesthesia for non-cardiac vascular surgery to develop a multiple variable model assessing~     the risk for postoperative myocardial ischemic events.~   "
20287|NCT03301428|"~     This trial aims at comparing the effectiveness of different didactic tools developed for~     patients with chronic pain to correct misbeliefs and improve disability in patients with~     chronic low back pain~   "
14628|NCT03375463|"~     This study has three parts. Each participant will enroll in one part.~      Part A: The purpose of Part A is to compare study drug LY3298176 solution formulation to a~     powder formulation mixed with water and given subcutaneously (SC) (just under the skin). Part~     A will measure how much of the study drug gets into the blood stream and how long it takes~     the body to get rid of it.~      Part B: The purpose of Part B is to evaluate the safety and tolerability of LY3298176~     intravenous (IV) formulation when administered into a vein.~      Part C: The purpose of Part C is to evaluate the safety and tolerability of LY3298176~     following multiple SC weekly doses of a solution.~      This study will last approximately 70 days for Part A or Part B and 92 days for Part C. This~     does not include screening. Screening is required within 28 days prior to the start of the~     study.~   "
14629|NCT03375450|"~     This is a study comparing the effects of ICS containing treatments in patients with chronic~     obstructive pulmonary disease (COPD) in a real world setting, using the UK Clinical Practice~     Research Datalink (CPRD) linked with Hospital Episode Statistics (HES). The main outcome to~     be assessed is exacerbation rates.~   "
14630|NCT03375437|"~     This trial is a multicenter, prospective cohort study aiming to describe molecular profiles~     of soft tissue sarcoma (STS) with complex genomic profiles in particular to assess the~     incidence of NTRK1/2/3, ROS1 or ALK gene fusions to direct such patients through an ongoing~     clinical trial with entrectinib when appropriate. An exploratory translational program is~     also correlated to this trial in order to analyse immune gene expression.~   "
14631|NCT03375424|"~     This study on biologics (Vedolizumab/anti-TNF) in the treatment of inflammatory bowel disease~     (IBD) patients in Germany extends the prospective documentation of efficacy in induction and~     maintenance therapy of anti-TNF to the use of Vedolizumab with a particular interest in the~     construction of a multifactorial model to predict long-term responses and favorable disease~     outcome or to predict severe side effects caused by therapy with biologics. Little data are~     available on the efficacy and safety of biologics in Germany in a real world situation. While~     the increasing use of anti-TNF-alpha antibodies in IBD-patients the new therapy with~     Vedolizumab opens up new opportunities in IBD-therapy, it may also pose new options and~     problems in terms of efficacy and predictors of response and potential side effects.~   "
14632|NCT03375411|"~     This is a First In Man study with the aim to know the safety and effectiveness of a novel~     bare metal stent (INC-1) in the treatment of de novo coronary lesions in patients with stable~     coronary angina and unique coronary lessions.~   "
14633|NCT03375398|"~     This study was a partly controlled laboratory-based study comparing the short-term~     postprandial blood glucose and insulin responses produced by 3 test meals containing white~     rice alone or with SUGARDOWN™ (Galactomannan) in overweight adults.~   "
14634|NCT03375385|"~     Pre-operative anxiety leads to higher sympathetic stimulation. Propofol in the main drug used~     during interventional or imaging techniques that need sedation. Also, dexmedetomidine causes~     sedation, analgesia, sympatholytic properties, without respiratory depression.In stereotactic~     brain biopsy; patient discomfort due to drilling a hole through the skull and the advancement~     of the biopsy needle make the patient in need for good sedation and analgesia.~   "
14635|NCT03375372|"~     This study began enrollment in 2003 with final report completed in October of 2015. This~     submission is being provided to acquire an NCT number.~      This study was successfully executed according to protocol with full enrollment and~     completion of 89.7% of subjects. Subjects were enrolled into a two arm study 1) Combined~     therapy (scaling and root planing plus Crest products) vs. 2) delayed treatment. Subjects~     were followed for 6 months and a wide and extensive battery of biological samples were~     collected to determine the effects of treatment on the local and systemic inflammatory~     response.~   "
14636|NCT03375359|"~     Combined first-trimester screening represents the gold standard of risk assessment for the~     presence of trisomy 21, 18, and 13. The concept is based on the age risk, the measurement of~     fetal nuchal translucency (NT), and the determination of serum markers free beta-hCG and~     PAPP-A in maternal blood.~      In recent years it has been shown that the risk assessment can be improved by combining~     in-depth ultrasound and cell-free DNA analysis from maternal blood. In their latest study,~     the investigators were able to detect all fetuses with trisomy 21, 18, and 13 through this~     procedure. No normal fetus displayed an increased risk. In contrast, the detection rate in~     classic, combined first-trimester screening is about 95% and the false-positive rate is 3-5%.~     In this study the investigator examine the test quality - especially the false positives - of~     cell-free DNA analysis on trisomy 21, 18 and 13 as well as on the microdeletion 22q in 1000~     pregnancies.~   "
14637|NCT03375346|"~     The purpose of this study is to investigate the effect of the whole body vibration exercise~     on cortical activity and gait function in patients with chronic stroke.~   "
14638|NCT03375333|"~     This study explores how Point of Care Ultrasound (POC-US) is used in general practice in~     Denmark and how it affects the diagnostic process and treatment of patients.~      Twenty general practitioners (GPs) will register information each time they use POC-US during~     a one month period. The information will include indications and frequencies of the performed~     POC-US examinations, change in tentative diagnosis, plan, and treatment before and after the~     use of POC-US in relation to confidence in the tentative diagnosis, findings and quality of~     the POC-US examination.~      This is an observational study without any intervention.~   "
14639|NCT03375320|"~     This randomized phase III trial studies cabozantinib S-malate to see how well it works~     compared with placebo in treating patients with neuroendocrine tumors previously treated with~     everolimus that have spread to nearby tissues or lymph nodes, have spread to other places in~     the body, or cannot be removed by surgery. Cabozantinib S-malate is a chemotherapy drug known~     as a tyrosine kinase inhibitor, and it targets specific tyrosine kinase receptors, that when~     blocked, may slow tumor growth.~   "
14640|NCT03375307|"~     This phase II trial studies how well olaparib works in treating patients with urothelial~     cancer with DNA-repair defects that has spread to other places in the body and usually cannot~     be cured or controlled with treatment. Olaparib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth.~   "
14641|NCT03375294|"~     The purpose of this study is to understand nitrous oxide effects in post traumatic stress~     disorder (PTSD)~   "
14642|NCT03375281|"~     The aim of this study is to evaluate clinical outcome of RFA for small single nodular HCC~     using no touch technique with separable clustered electrode (Octopus) in a prospective manner~   "
14646|NCT03375229|"~     Myofascial Pain is a clinical condition of myalgic pain characterized mainly by the presence~     of Myofascial Trigger Points. Trigger points can be active or latent and they are described~     as a hypersensitive spot within a taut band in the muscle. The use of a computer for long~     periods has been shown as a trigger the trigger points. Dry Needling and Low-Level Laser~     Therapy (LLLT) has been described as good resources to treat myofascial pain. The hypothesis~     is that the association of the purposed interventions will have greater effects than only the~     dry needling intervention. The objective is to evaluate the effects of the dry needling and~     the laser in the treatment of upper trapezius trigger point on women. This study is composed~     of an evaluation and an intervention proposal with dry needling and LLLT to treat myofascial~     trigger points. The sample will be composed of 60 women, with 18 to 65 years old, divided~     into three groups. Twenty individuals will be in group Dry-On that will receive dry needling~     intervention on the trigger point, followed by LLLT intervention on. Twenty individuals will~     be in group Dry-Off that will receive dry needling intervention on the trigger point,~     followed by LLLT intervention turned off. Twenty individuals will be in group Control that~     will receive dry needling intervention at 1.5 cm from the trigger point, followed by LLLT~     intervention turned off. All interventions will be performed in one session. Outcome measures~     for pain, pressure pain threshold, functionality, and muscle activity will be collected.~   "
14647|NCT03375216|"~     Few studies have used quantitative sensory tests to study the effect of chronic opioid~     treatment on sensation. The investigators will test chronic pain patients who are on~     different MEDDs, normal volunteers, and patients undergoing an opioid taper. This will be the~     first study to perform sensory testing on patients while undergoing an opioid taper on an~     outpatient basis.~   "
14648|NCT03375203|"~     The purpose of this 2 month phase 2b study is to investigate the dose response of 3 doses of~     JNJ-42847922 (Seltorexant) (5,10 and 20 mg) compared to placebo and zolpidem on sleep onset~     and maintenance and to further document safety and tolerability of JNJ-42847922 (Seltorexant)~     upon multiple (14 days) dose administration in participants with insomnia disorder.~   "
14649|NCT03375190|"~     Continuous peripheral nerve block catheters are used for prolonged analgesia, but are often~     associated with complications such as catheter failure or dislodgement. This is a single~     center, prospective study to compare peripheral nerve catheter securement techniques at the~     insertion site in healthy volunteers.~   "
14650|NCT03375177|"~     The main reason for RelevarEM project is the creation of a registry based on a web platform~     to facilitate the collection of epidemiological data of multiple sclerosis patients from~     multiple sources in Argentina. The platform will provide the data in a global way that will~     show the frequency and distribution of the disease in our environment at low cost.~   "
14651|NCT03375164|"~     The proposed clinical trial is a single-dose controlled trial using~     rAAVrh74.MHCK7.micro-dystrophin for DMD subjects. Cohort A will include six subjects ages 3~     months to 3 years, and Cohort B will include six subjects ages 4 to 7 years old. All subjects~     will receive intravenous micro-dystrophin vector (2X10e14 vg/kg in 10mL/kg)~   "
14652|NCT03375151|"~     The problem of cognitive decline among the aging population has become a significant health~     burden, especially in light of the increase in the prevalence of dementia with age For~     patients with MCI (Mild cognitive impairment) there are various recommendations to deal with~     the disorder, including behavioral recommendations for physical exercise. Some~     recommendations could also be found for cognitive practice. However, currently, there is no~     consensus regarding effective cognitive treatment or practice for MCI. Among the populations~     suffering from MCI, there is a significant segment of patients with amnestic disorder. For~     these patients, it seems that cognitive training of memory, including verbal memory, is very~     important. In recent years, we have developed an effective tool for managing rehabilitation~     practice by monitoring the patient's engagement with an easy-to-use EEG~     (electroencephalogram) tool. We have shown in a variety of rehabilitation settings, that when~     the patient is recruited, the clinical improvement is significantly better. The aim of this~     study is to evaluate the ability to harness the EEG monitoring of brain engagement to achieve~     functional improvement in verbal memory training in patients with Amnestic MCI.~   "
14653|NCT03375138|"~     This study compares the movement of Belatacept drug products, whose active pharmaceutical~     ingredient has been manufactured by 2 different processes, into, through and out of the body~     (pharmacokinetics/PK) of healthy volunteers. Eligible participants will be randomly assigned~     to one of two groups, and will receive a single dose of a belatacept product once during a~     4-day stay at a study site.~   "
14654|NCT03375125|"~     Randomized controlled tril to evaluate the safety and efficacy for the combination of L.~     reuteri ATCC PTA 5289 & L. reuteri DSM 17938 in pregnant women with periodontitis and/or~     gingivits to improve oral health and at the same time reduce the risk for prematurity or~     intrauterine growth retardation (IUGR).~      Women in this study wil receive L. reuteri Prodentis (L. reuteri DSM 17938 & L. reuteri ATCC~     PTA 5289 ) at a dose of 2x10^8 Colony Forming Units (CFU). One lozenges is to be taken twice~     per day (one in the morning and one in the afternoon) giving a total daily dose of at least~     4x108 CFU/day since randomization until delivery. The control group will receive placebo~     lozenges which contains identical ingredients except for lacking the bacteria. One lozenges~     is to be taken twice per day (one in the morning and one in the afternoon. The study product~     will be kept refrigerated (+20 - +80 C)~   "
14655|NCT03375112|"~     The fascia iliaca compartment block (FICB) is a regional block that anesthetizes the femoral,~     obturator, and lateral femoral cutaneous nerves around the hip. The purpose of this study is~     to determine whether FICB can reduce postoperative pain and increase progress with physical~     therapy after total hip arthroplasty (THA). This randomized, double-blind, clinical trial~     will randomize patients to receive either a FICB or placebo after THA. The primary outcomes~     will be pain scores reported by the patient post-operatively.~   "
14707|NCT03374436|"~     Prolonged sitting has been shown to impair metabolism and vascular function. The overall~     purpose of this study is to determine if breaking up prolonged (9 hours) of sitting with~     brief (~20 second) stair climbing exercise snacks can improve markers of metabolic control~     and vascular health in healthy young male participants. An additional purpose is to determine~     if saliva insulin can be used as a valid indicator of blood insulin when measured throughout~     the day in sedentary and active conditions and when diets with different amounts of~     carbohydrates are consumed.~   "
14708|NCT03374423|"~     neuropathic pain can occur following any surgical procedure on the breast ..~   "
14656|NCT03375099|"~     In 2013, the National Guard reported a suicide rate that was substantially higher than both~     the general population and the active duty component of the United States military. The~     prototypical National Guard suicide decedent appears to be a young male firearm owner not~     currently deployed who dies using his own gun. Prior research within the military has~     revealed that soldiers are unlikely to seek out or engage in mental health services. In sum,~     current best practices in suicide risk assessment are poorly equipped to identify the~     individuals most likely to die by suicide. This study aims to examine the acceptability,~     feasibility, and utility of a single lethal means counseling session as part of a suicide~     prevention approach targeting demographic groups overrepresented in National Guard firearm~     suicides. 232 firearm-owning male National Guard personnel will be randomized to one of four~     conditions, each of which requires a single 15-25 minute session: (1) lethal means counseling~     (2) lethal means counseling plus the provision of free gun locks (3) health and stress~     control condition (4) health and stress control condition plus the provision of free gun~     locks. The investigators anticipate that those who receive lethal means counseling will~     subsequently store their personal firearms more safely and report being more willing to store~     their firearms away from the home during any hypothetical future suicidal crisis. The~     overarching goal of each hypothesis is to examine the extent to which gun owning young male~     National Guard personnel at varying levels of suicide risk are willing to engage in means~     safety.~   "
14657|NCT03375086|"~     This is a Phase 1, multi-center, open-label, dose-escalation oncology study of APX3330 in~     patients with advanced solid tumors.~   "
14658|NCT03375073|"~     The emotional and cognitive impact of positive communication between caregivers remains~     uninvestigated. The investigators hypothesize that positive communication during medical~     transmission can increase clinical performance for managing a subsequent stressful unexpected~     adverse event.~   "
14659|NCT03375060|"~     This study is looking at a cohort of patients who have undergone treatment for Barrett's~     Esophagus (BE) and who have experienced complete eradication of the disease. The aim of the~     proposed study is to evaluate the histologic features of the neosquamous epithelium (NSE)~     following complete eradication of intestinal metaplasia (CE-IM) in patients undergoing~     routine surveillance biopsies and compare these data to a direct measure of reflux using 24hr~     pH impedance, to determine the correlation between histology and persistent reflux. These~     data will allow us to more accurately risk stratify patients for recurrence of BE following~     EET.~   "
14660|NCT03375047|"~     This Phase 1/2, first-in-human study will evaluate the safety and tolerability of single and~     multiple escalating doses of MRT5005 administered by nebulization to the respiratory tract of~     adult subjects with CF. This study will also assess the delivery of the drug to bronchial~     epithelial cells following multiple doses of MRT5005, and will characterize its biological~     activity by measuring changes in CFTR protein levels and CFTR chloride channel activity~     post-treatment.~   "
14661|NCT03375034|"~     Neuropathic pain affects about 7% of the general population in European countries.~     Meta-analyses indicate that only a minority of neuropathic pain patients has adequate~     response to drug therapy and management of neuropathic pain is still an unmet medical need.~     New insights into the contribution of defined subtypes of GABAA receptors (GABAARs) to the~     different clinical effects of benzodiazepines, including analgesia, have suggested that~     α1-sparing selective benzodiazepines, such as N-desmethylclobazam (NDMC), may be a new~     realistic alternative for the treatment of neuropathic pain. Results from our previous study~     in healthy volunteers assessing the antihyperalgesic and sedative effects of benzodiazepines~     on a UVB-induced pain model of central sensitization showed that, at the time of maximum~     effect, clobazam and clonazepam antihyperalgesic effect was greater than placebo by~     respectively 15.7% (95% CI 0.8 - 30.5) and 28.6% (95% CI 4.5 - 52.6), p<0.05. Moreover~     difference in sedation (VAS), as compared to placebo, was only significant for clonazepam~     26.3mm (95%CI 15.0-37.7), p<0.001. Our preclinical data also demonstrate that, in recombinant~     receptors, NDMC has a better α2- over α1GABAARs activity ratio than clobazam and diazepam.~     And, unlike diazepam, NDMC caused no or modest sedation at antihyperalgesic doses in two~     strains of wild-type mice. In addition NDMC α2/α1 in vitro activity profile and long term~     clinical experience from its marketed parent compound (clobazam) make it an advisable~     clinical candidate for further proof-of-concept assessments in human. Therefore the Geneva~     University Hospitals have manufactured a new chemical entity and initiated a drug development~     program for NDMC starting with this proof-of-concept phase 1b randomized double-blind~     crossover (4 arms) study that will assess the analgesic and sedative effects of NDMC 20mg and~     60mg compared to clonazepam 1.5 mg or placebo on a UVB-induced erythema pain model in healthy~     volunteers.~   "
14662|NCT03375021|"~     A Randomized, Double-Blind, Two-Period Crossover Study to Assess the Efficacy And Safety of~     the Ampakine® Compound, CX717, versus Placebo in Adults with Attention-Deficit Hyperactivity~     Disorder~   "
14663|NCT03375008|"~     1. To evaluate feasibility of using multiparametric Magnetic resonance(MR) imaging to~          predict nonalcoholic steatohepatitis(NASH)~        2. To develop non-invasive diagnosis tool using multiparametric Magnetic resonance(MR)~          imaging for nonalcoholic steatohepatitis(NASH)~   "
14664|NCT03374995|"~     This randomized pilot clinical trial studies how well topical keratin works in treating~     radiation dermatitis in patients with breast cancer. Radiation dermatitis is a skin condition~     that is a common side effect of radiation therapy. The affected skin becomes painful, red,~     itchy, and blistered. Topical keratin may help to improve skin appearance and hydration in~     patients with breast cancer.~   "
14665|NCT03374982|"~     Title: Effect of the DentalVibe injection system on pain during local anesthesia injections~     in children.~      Purpose: The purpose of this study is to compare self-reported pain scale measurements using~     the Wong-Baker FACES pain rating scale from an experimental group (local anesthesia injection~     with DentalVibe system) and a control group (traditional local anesthesia injection with~     DentalVibe system turned off) in children.~      Eligibility: Children age 5-11 years old who require local anesthesia for bilateral dental~     treatment at University of Nebraska Medical Center (UNMC) pediatric dental clinic. Children~     must understand and speak English.~      Interventions and evaluations: Each patient will have two separate restorative appointments~     where the DentalVibe will be used during local anesthetic injections. One appointment the~     DentalVibe will be turned on and one appointment the DentalVibe will be turned off. After~     each injection the child will be shown the Wong Baker FACES Pain Rating Scale and asked to~     pick a face associated with their level of hurt during the injection.~      Follow-up: All children will be followed up with any necessary recommended dental treatment.~   "
14666|NCT03374969|"~     The aim of this study is to experimentally assess whether an early parenting intervention for~     maltreating parents results in differential epigenetic marking of children's genome,~     particularly of DNA associated with immune system functioning, obesity, and mental health.~   "
14668|NCT03374943|"~     This is a study of drug KB004 in patients with recurrent glioblastoma (GBM). Eligible~     patients with measurable tumours will receive an initial trace (5mg) dose of zirconium~     labelled KB004 (89ZrKB004) on day 1 followed by sequential Positron emission tomography (PET)~     imaging over 1 week to determine its biodistribution into GBM and normal tissues. Safety~     assessments and pharmacokinetic (movement of drug) sampling will also be undertaken over this~     time. On Day 8, patients commence weekly KB004 infusions over 2 hours with standard~     premedications. Three cohorts are planned in this study (3.5mg/kg, 5.25 mg/kg, 7.9 mg/kg;~     additional dose levels may be explored based on toxicity, efficacy and biodistribution data~     as determined by the safety monitoring committee). On day 36, patients receive both 89ZrKB004~     and KB004, allowing assessment of receptor occupancy to guide recommended phase two dose~     (RPTD) determination. Response rate (RANO) and survival data will be collected and patients~     benefiting may continue KB004 treatment until disease progression. Primary objective: to~     determine the toxicity and recommended phase two dose (RPTD) of KB004 in patients with~     advanced Glioblastoma (GBM).~      Secondary objectives: to determine the biodistribution and pharmacokinetics of 89ZrKB004; to~     determine frequency of EphA3 (ephrin receptor A3) positive glioblastoma in archival specimens~     and by 89ZrKB004 scans, and correlate with known biomarkers; to describe response rates per~     RANO criteria (Response Assessment in Neuro-Oncology Criteria) and pharmacodynamics following~     KB004 infusion; Exploratory objectives: to perform exploratory analysis between clinical~     outcomes and biodistribution/Pharmacokinetics (PK)/pharmacodynamics (PD) data, including from~     matched biopsies.~   "
14669|NCT03374930|"~     The main objective of this study is to evaluate, in a prospective cohort, the link between~     preoperative contractile reserve of oesophagus evaluated by high resolution manometry (HRM)~     and the occurrence of post operative dysphagia after anti-reflux surgery.~   "
14670|NCT03374917|"~     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of 4~     weeks of continuous infusion with ABBV-951 in adult subjects with Parkinson's Disease (PD).~   "
14671|NCT03374904|"~     The objective of this study is to implement a Video Feedback (VF) intervention to enhance~     Parental Reflective Function in primary caregivers of inpatient psychiatric children. Because~     there is no published research using VF with parents of children with severe psychopathology~     and in hospitalized context, this study is a pilot study.~      The research will include a qualitative and quantitative study; it will take place in a~     public hospital in Valparaíso, Chile. In the qualitative study, participants will be six~     primary caregivers who received the intervention and three stakeholders from Child Unit. For~     caregivers a semi-structured interview will be applied to know subjective experience gained~     by intervention regarding the perceived satisfaction. For health professional also a~     semi-structured interview will be applied to collect information pertinent to the feasibility~     of performing such intervention. The information obtained from the interviews will be~     analyzed with Grounded Theory model.~      The quantitative study will be conducted amongst all tutors of children aged between 6 and 14~     hospitalized in a child psychiatry ward between August 2017 and December 2018. The expected~     sample size is 30 subjects in total; 10 for the control group and 20 for the experimental~     group.~      A four module of Video Intervention Therapy (VIT) was designed, each module includes a (video~     recorded) play session and a group VF session.~      The evaluation of the caregivers at the beginning of the intervention will include a~     psychosocial questionnaire, GHQ-12 , Five Minutes Speech Sample (FMSS) where RF will be~     codified, Operationalized Psychodynamic Diagnosis - Structure Questionnaire (OPD.SQ). The~     Strengths and Difficulties Questionnaire will be applied to children, in addition to the~     Children Global Assessment Scale, (CGAS). After every VF session a new FMSS, GHQ-12 and CGAS~     will be made. A follow-up will be performed three months after the beginning of the~     intervention with FMSS, GHQ-12 for caregivers and SDQ and CGAS for children.~      To determine Effect Size and Intra Class Correlation, the results will be analyzed using a~     multiple linear regression.~   "
14672|NCT03374891|"~     The investigators goal is to assess real-world effectiveness of patient decision aids (PtDA)~     for high-risk decisions using the implantable cardioverter-defibrillator (ICD) as a model.~   "
14673|NCT03374878|"~     Cross sectional study investigating the effect of strength training in users and non-users of~     oral contraceptives (OC) (2nd generation OC)~   "
14674|NCT03374865|"~     Digital communication media like video‐interaction (cf. Skype) are increasingly being adopted~     in institutional environments like hospitals for physician‐patient interactions. We may~     expect that the use of a digital medium affects these interactions in various ways and on~     various levels. In video‐interaction, eye contact for example is impossible due to the~     position of the camera, which implies interactional behavior through gaze is impaired. This~     may influence who speaks when, if and how the participants avoid/ solve misunderstandings,~     etcetera. This project makes headway in our understanding of the impact of new communication~     media on the role of language‐in‐use as a rich semiotic system, specifically in institutional~     interaction. This type of contextualized research reveals which communicative aspects users~     consider important, how they manage their institutional relationship through them and how~     they go about solving communication problems.~      The project compares the interaction of physicians and patients in video‐mediated~     consultations to their traditional, face‐to‐face counterparts on both the verbal and the~     nonverbal (gaze) level. The affordances of video‐consultations with relevance to~     institutional goals and identities are analyzed through a comparison with the interaction in~     face‐to‐face consultations. The approach used is Conversation Analysis, which involves~     finding patterns on both the verbal and non‐verbal level (in sequences, turn design,~     preference, etc.) in order to answer the question what goals and tasks the participants~     achieve and what dilemma's or problems they aim to solve in their talk. This study will~     provide insights in the limitations and advantages of both channels of communication. Best~     practices will be generated and outcomes of the analyses will be used to develop reco~   "
14675|NCT03374852|"~     This study is a single arm, phase II trial, of 45 patients with locally advanced pancreatic~     ductal adenocarcinoma. The efficacy of the novel drug and mitochondrial inhibitor, CPI-613,~     in conjunction with standard-of-care FOLFRINOX, as a first-line therapy will be evaluated.~     Pre-treatment, diagnostic biopsy tissue will be collected when available, and clinical data~     will be evaluated to determine if the combination results in improved overall survival~     compared to historical experience.~   "
14676|NCT03374839|"~     To improve the efficacy of immunotherapy for cancer, recent studies focused on specific~     targets to redirect the immune network toward eradicating a variety of tumors and~     ameliorating the self-destructive process.~      A clinically relevant immune escape mechanism in melanoma is the activation of the Programmed~     cell Death-1 (PD-1) receptor on infiltrating T cells. By blocking PD-1 receptors with~     anti-PD-1 monoclonal antibodies (mAbs), T-cells are unaffected by the PD-L1 expressed on~     tumor cells and the patients T cells are free to respond to melanoma antigens and attack~     tumor cells. So the objective of this trial is to evaluate the safety and the efficacy of a~     combined therapy Nivolumab and adoptive T cell therapy in metastatic melanoma patients.~   "
14677|NCT03374826|"~     Axillary lymph node status is an important prognostic factor for patients with breast cancer.~     After breast cancer diagnosis, current nodal staging consists of axillary ultrasound (US)~     combined with tissue sampling when deemed necessary. In case of positive axillary lymph~     nodes, patients will undergo axillary lymph node dissection (ALND). In case of no suspicious~     axillary lymph nodes (i.e. clinically node negative patients), patients will undergo sentinel~     lymph node biopsy (SLNB). This surgical nodal staging is accompanied by co-morbidity. In~     theory, if non-invasive imaging can evaluate the lymph node status accurately, a node~     negative patient would no longer have to undergo axillary surgery. Since MRI is suitable for~     soft tissue imaging and PET has the advantage of showing increased metabolic uptake in lymph~     node metastases, a combination of these techniques in hybrid PET/MRI would be highly~     desirable. If dedicated axillary hybrid PET/MRI is equally accurate to SLNB for the detection~     of negative axillary lymph nodes, work-up could be more efficient by bypassing SLNB. However,~     the accuracy of dedicated axillary hybrid PET/MRI needs to be compared with the pathological~     outcome of SLNB (gold standard) first.~   "
14678|NCT03374813|"~     The hypothesis tested in this clinical trial is that a biomimetic synthetic bone graft~     substitute (MimetikOss, Mimetis Biomaterials) with similar properties to those of human bone~     can reach a clinical outcome non inferior to that of a deproteinized bovine bone matrix bone~     graft substitute (Bio-Oss, Geistlisch) in an alveolar ridge preservation procedure followed~     by implant placement in terms of bone volume changes (primary end point), bone histological~     observation implant stability and bone level changes (secondary end points).~   "
14679|NCT03374800|"~     Patients who are critically ill in the in the Intensive Care Unit (ICU), especially those who~     need a breathing machine, can develop ulcers in the stomach that bleed. To prevent bleeding,~     many such patients around the world receive a drug called pantoprazole that decreases acid~     production. However, today, compared to decades ago, critically ill patients rarely develop~     gastrointestinal bleeding. This decrease is likely due to modern medicine, better~     resuscitation and earlier feeding. There may also be harms associated with pantoprazole and~     other drugs that reduce acid levels in the stomach including lung infections (pneumonia) and~     bowel infections (clostridium difficile). Studies in this area are old and of modest quality.~     Therefore, it is difficult to know whether pantoprazole does decrease stomach bleeding these~     days, or whether the possible harms of lung and bowel infections are actually more common and~     more serious problems. The goal of this international study is to determine if, in critically~     ill patients using breathing machines, the use of pantoprazole is effective in preventing~     bleeding from stomach ulcers or whether it causes more problems such as lung infection~     (pneumonia) and bowel infection (Clostridium difficile), or whether pantoprazole has no~     effect at all. Whether the harms are worth the benefits, and whether the benefits are worth~     the costs, will be determined by an economic analysis to inform patients, families,~     clinicians, and healthcare systems globally.~   "
14680|NCT03374787|"~     A single center study evaluating the performance of an externally worn sound processor for a~     transcutaneous bone anchored hearing system using audiological outcomes measures such as~     aided thresholds and speech intelligibility and self evaluation questionnaires.~   "
14681|NCT03374774|"~     The purpose of this study is to collect information about the participant's ability and~     willingness to pay for NovoMix 30 using a modern device, which is prescribed to the~     participant by the study doctor for Type 2 Diabetes Mellitus according to routine clinical~     practice. The study aims to obtain data that can guide prescribers' understanding of the~     ability and willingness to pay for NovoMix 30 FlexPen or Penfill among participants in the~     growing middle class in India and Egypt. The decision to prescribe NovoMix 30 FlexPen or~     Penfill has been made independent from this study.~   "
14682|NCT03374761|"~     Families First Home Visiting Program (Families First) is a parenting support program anchored~     on children's rights that gives parents clear guidance on child development, parenting, and~     positive discipline practices. Families First is an adaptation of the Positive Discipline in~     Everyday Parenting (PDEP) Program for the West Java context. This trial aims to evaluate the~     effectiveness of Families First. This is a pragmatic, delayed-entry, parallel-group,~     stratified, cluster-randomized controlled trial in a real-world setting. Twenty rural and~     urban villages in the Cianjur district of Indonesia, involving 720 caregivers of children up~     to 7 years of age, are randomized to two parallel arms. Villages receive either a parenting~     program consisting of 10 group sessions and 4 home visits or the standard community health~     and social services. After completion of the trial period, the delayed group is offered the~     program. The primary outcome is self-reported frequency of corporal/physical and emotional~     punishment. The secondary outcomes are indicators of involved and positive parenting.~     Concurrent process evaluation and qualitative research are conducted to identify program~     satisfaction and facilitators and barriers to the implementation. Outcome data are collected~     immediately after the intervention and six months later. The results will be used to inform a~     violence prevention strategy in West Java and possible scale up in of the intervention in~     Indonesia.~   "
14683|NCT03374748|"~     This study is a secondary analysis of the dietary, phenotypic and demographic data collected~     within the National Adult Nutrition Survey (NANS), Ireland, to determine meal patterns using~     a variety of statistical methods.~   "
14684|NCT03374735|"~     This is a prospective, multicenter, single-arm trial to evaluate the safety and performance~     of SETALUM™ Sealant in sealing suture lines at the anastomosis between native vessels and~     synthetic ePTFE vascular patch used during open vascular surgery.~   "
14694|NCT03374605|"~     Behavioral adaptation is particularly relevant to anxiety and related disorders, where~     exposure-based therapies rely on such adaptation as part of behavior therapy.. However, while~     initial fear reactions generalize easily across contexts, subsequent adaption of behavior~     through learning is context-specific. The primary goal of this study is to investigate~     whether transcranial direct current stimulation (tDCS) can be used to acutely impact~     generalization of subsequent learning across contexts in an experimental paradigm. As part of~     this study, participants will complete a clinical interview and questionnaires, as well as a~     computer task asking them to make choices between stimuli on the screen and during which they~     may or may not receive tDCS.~   "
14709|NCT03374397|"~     The purpose of this study is to compare hemostasis, ovarian function preservation effect, and~     safety about intraoperative bleeding with SurgiGuard@ in women who underwent laparoscopic~     unilateral ovarian cystectomy~   "
14685|NCT03374722|"~     Most critically ill patients encounter pain and distress from acute illness, medical~     procedures and devices as well as routine care in the intensive care units (ICU). Opioids are~     principal analgesics that alleviate moderate to severe pain and facilitate patients to~     co-operate the course of treatment. However, prolong administration of opioids especially in~     mechanically ventilated patients can cause withdrawal symptoms if analgesics are rapidly~     weaning or acutely disruption. The opioid withdrawal symptoms (OWS) are well reported in~     critically ill children that cause discomfort and prolong weaning from mechanical~     ventilation. Weaning opioids and treatment of withdrawal symptoms are needed in order to~     decrease ventilator days, ICU and hospital length of stay. Conversely, there is lack of~     knowledge about incidence, clinical presentation, time course and appropriated assessment~     tool for withdrawal detection. Therefore, we conduct the study to explore an incidence of~     OWS, to identify factors associated OWS, to establish the assessment tool for OWS, and to~     report efficacy of the pharmacological treatment for OWS, in adult critically ill patients.~   "
14686|NCT03374709|"~     To evaluate the affect Oxtellar XR (Extended Release) has on neurology patients with~     trigeminal neuralgia (TN), and if it impacts their quality of life.~   "
14687|NCT03374696|"~     The study evaluated if interactive theater in school sex education affects student knowledge,~     attitudes and behavior regarding condom use. The intervention group got a play, value~     exercises, chlamydia games, condom school and interactive replay with professional actors and~     staff from a youth guidance center. The control group got standard sex education from school~     staff, based on the education guidelines of the Swedish National Agency for Education.~   "
14688|NCT03374683|"~     Children's risky play is associated with a variety of positive developmental, physical and~     mental health outcomes, including greater physical activity, self-confidence and risk~     management skills. Children's opportunities for risky play have eroded over time, limited by~     parents' fears and beliefs about risk, particularly among mothers. We have developed a~     digital and in-person workshop version of a tool to reframe parents' perceptions of risk. We~     will examine whether the tool increases mothers' tolerance for risky play and influences~     parenting behaviour change, in the short and long term, and whether these changes are greater~     than those in the control group.~      We will conduct a single-blind (researchers and outcome assessors) randomized controlled~     trial and will recruit at total of 501 mothers of children aged 6-12 years. The risk~     reframing (RR) digital tool is designed for a one-time visit and includes three chapters of~     self-reflection and experiential learning tasks. The RR in-person tool is a 2-hour~     facilitated workshop in which participants are guided through discussion of the same tasks~     contained within the digital tool. The control condition consists of reading the Position~     Statement on Active Outdoor Play.~      Primary outcome is increased tolerance of risk in play, as measured by the Tolerance of Risk~     in Play Scale. Secondary outcome is self-reported attainment of a behaviour change goal that~     participants set for themselves. We will test the hypothesis that there will be differences~     between the experimental and control groups with respect to tolerance of risk in play and~     goal attainment.~   "
14689|NCT03374670|"~     To asses the safety of intravitreal Zimura™ (complement factor C5 inhibitor) administered in~     combination with Eylea® in treatment experienced subjects with idiopathic polypoidal~     choroidal vasculopathy~   "
14690|NCT03374657|"~     CPK850 is a recombinant adeno-associated virus 8 (AAV8) vector containing the human RLBP1~     gene. The purpose of this first-in-human study is to explore the maximum tolerated dose (MTD)~     of CPK850 as determined by the single ascending dose ranging portion of the study. This study~     will also evaluate the safety and potential efficacy of CPK850 on improving visual function~     in patients with decreased visual function from RLBP1 retinitis pigmentosa due to biallelic~     mutations in the RLBP1 gene.~   "
14691|NCT03374644|"~     Sampling end tidal gas via nasal prong has been shown to be a noninvasive and reliable method~     of monitoring end-tidal CO2 in spontaneously breathing patients. It is used to assess the~     adequacy of ventilation and enhance patient safety. When using a nasal cannula to sample~     expired gases by a patient, air from the room may dilute the sample and affect the accuracy~     of ETCO2. It is necessary to have accurate values of ETCO2 during intravenous sedation to~     detect respiratory depression including apnea. Therefore, the aim of our study is to assess~     the correlation of end tidal carbon dioxide to arterial partial pressure of carbon dioxide by~     using Sentri nasal cannula among sedated and non-sedated patient undergoing cataract surgery~     under local anaesthesia. Patients who are classified as ASA physical status 1 to 3 with age~     more than 18 years' old, and are scheduled for elective eye surgery in which arterial blood~     pressure monitoring is appropriate will be eligible. This study will be conducted at~     University Malaya Medical Centre.~   "
14692|NCT03374631|"~     This study investigates whether the way in which individuals process social stimuli can be~     altered, and specifically, whether feelings of paranoia and suspiciousness can be reduced by~     stimulating the brain's regulatory regions via transcranial Direct Current Stimulation~     (tDCS).~   "
14693|NCT03374618|"~     Systemic sclerosis (SSC) is a systemic disease characterized by limited or diffuse cutaneous~     sclerosis, microangiopathy, overproduction of autoantibodies and variable organ damage due to~     vasculopathy and/or fibrosis. The loss of self-tolerance is believed to be caused by the~     dysregulation of both innate and adaptive immune systems and may involve reactive oxygen~     species (ROS).~      Neutrophils are potent producers of ROS and may play a role in endothelial cells and~     fibrobasts dysfunction, as in autoantibodies generation. However, their role in SSC~     pathogenesis remains to be determined. Recent studies discovered abnormal regulation of~     neutrophil extracellular traps (NETs) in other auto-immune diseases such as systemic lupus~     erythematosus (SLE). NETs are web-like structures composed of chromatin backbones and~     granular molecules. They are released by activated neutrophils through a process called~     NETosis. Nets were first described in 2004 as a novel host defense mechanism to trap and~     kill foreign pathogens. Recent evidence shows that NETs also participate in the pathogenesis~     of a variety of inflammatory and autoimmune diseases, including SLE.~      We hypothesis that this phenomenon could be dysregulated in SSC as in SLE and could play a~     prominent role in the induction of autoimmunity, as well as in the induction and perpetuation~     of organ damages.~   "
14695|NCT03374592|"~     This study compares the use of conventional radiotherapy technique with volumetric~     intensity-modulated radiotherapy (VMAT) in the treatment of painful cancer metastases. Half~     of the patients will receive radiotherapy using a conventional technique, while the other~     half will receive their treatment using a the VMAT technique.~   "
14700|NCT03374527|"~     The aim of the study is to investigate the link between pro-inflammatory T cells responses~     arising in the skin in patients with cutaneous psoriasis and those present in the joints of~     patients developing psoriatic arthritis.~      The study is based on the hypothesis that a fraction of T cells with memory phenotype can~     recirculate from the skin and relocalize at extracutaneous sites including enthesis or~     synovial tissue thus propagating the pro-inflammatory cycle. This could represent a~     pathogenic mechanism in the development of PsA.~      The main aim of the study is to define the phenotypic and functional differences of~     circulating T cells in patients cutaneous psoriasis, patients with psoriatic arthritis and in~     control group of healthy subject.~      To this end we analyze the expression of cell surface markers of central memory (TCM),~     effector memory (TEM) and effector (Teff) cells, within this subsets wel evaluate the~     expression of chemokine receptors as well as skin and tissue homing molecules. We also~     evaluate the T cell polarization towards Th1/Tc1 or Th17/Tc17 phenotype by evaluating the~     cytokine expression profile.~      In selected patients with PsA we analyze in parallel the phenotype and the cytokine profile~     of T cell subpopulations in peripheral blood and in synovial fluid, The results of this study~     could possibly allow us to define distinctive features of circulating T cells in patients~     with PsA and to understand the link between circulating and synovial fluid T cells in~     patients with PsA.~   "
14701|NCT03374514|"~     Hearing is the ability to perceive sounds through the ear. If the transmission of sound is~     defective, the person suffers some degree of hearing loss. Cochlear Implants (CI) provide~     partial hearing by stimulating auditory nerve cells.~      The evaluation of the functionality of the CI is facilitated by several analysis tools, such~     as the clinical calibration software. This offers the possibility of measuring electrical~     impedances in the cochlea. The electrical impedance is the opposition to the current flow~     between two electrodes. It is composed of two main elements: resistance and reactance. The~     impedances in a cochlear implant are not stable over time. The value is minimal immediately~     after surgery, and increases progressively in the first 2 to 3 weeks after the procedure due~     to the immune response of the organism against a foreign body and the trauma of the array~     insertion. Several authors have suggested the use of topical or intravenous corticosteroids~     to decrease intracochlear fibrosis. The use of Dexamethasone could have a protective effect~     by reducing the initial inflammatory response, apoptosis, and delayed fibrosis, which could~     impact the impedance.~      There is limited evidence on the effect of intra-surgical topical corticosteroids on the~     impedance of the cochlear implant.~      The aim of this clinical trial is to evaluate the impact of topical dexamethasone on the~     electrical impedance of the cochlear implant, with special attention to the analysis of the~     capacitive component. It will be carried out through an experimental, prospective, randomized~     and double-blind study.~      Objective To determine whether the use of topical dexamethasone in a single dose applied in~     the tympanic cavity (middle ear) during cochlear implant surgery modifies the capacitive~     component of the electrical impedance of the electrodes in the cochlea before the activation~     of the cochlear implant.~      Material and methods A phase 3 clinical trial will be conducted. The design is a parallel,~     randomized, controlled and double-blind experimental study.~      Expected impact The use of local dexamethasone during cochlear implant surgery would decrease~     the inflammatory response, improving postoperative impedances.~   "
14702|NCT03374501|"~     This study was a partly controlled laboratory-based study comparing the glycemic and~     insulinemic indices of 3 test meals containing soft drink alone or with SUGARDOWN™~     (Galactomannan) in overweight adults.~   "
14703|NCT03374488|"~     The purpose of this study is to evaluate the efficacy and safety of pembrolizumab +~     epacadostat vs pembrolizumab + placebo as a treatment for recurrent or progressive metastatic~     urothelial carcinoma in patients who have failed a first-line platinum-containing~     chemotherapy regimen for advanced/metastatic disease.~   "
14704|NCT03374475|"~     The purpose of this study is to explore if the magnitude of treatment effect (JNJ-42847922;~     placebo) on symptoms of depression (as measured by Hamilton rating scale for depression-17~     [HDRS17], Sleep item-adjusted HDRS17, Anxiety/somatization factor score and the 6-item~     subscale from HDRS17 [HAM-D6]) differs across different levels of hyper-arousal status~     (characterized by Sleep parameters, ruminative response scale [RRS], Sleep and Worry visual~     analogue scale [VAS], quantitative electro-encephalography [qEEG], heart rate variability~     [HRV] and others).~   "
14705|NCT03374462|"~     At the conclusion of this project, investigators will have assessed the effectiveness of~     home-based telemedicine for improving multiple important clinical and patient-centered~     outcomes in a high-risk pediatric cohort with T1D.~      Aim 1. To test the hypothesis that home-based telemedicine is a feasible and acceptable~     method of care delivery for patients with poorly controlled type 1 diabetes (T1D) currently~     cared for at the University of California, Davis (UCD) Pediatric Endocrinology clinic.~     Specifically:~      A) Patients and families choose to participate in telemedicine visits as a supplement to~     in-person care; B) Patients and families can utilize secure, internet-based platforms to~     upload and share glucose meter data and to establish an audio-video connection with a~     diabetes specialist in their home settings; C) Patients and families are satisfied with the~     experience of home-based telemedicine and would choose to receive future diabetes care via~     this modality.~      Aim 2. To test the hypothesis that using home-based telemedicine, these patients can complete~     more frequent visits with a diabetes specialist than they previously completed via office~     visits alone.~      Aim 3. To test the hypothesis that increased contact with a diabetes specialist via~     home-based telemedicine will lead to significant improvement in glycemic control for these~     patients.~      Aim 4. To evaluate the effects of increased contact with a diabetes specialist via home-based~     telemedicine on high-cost health care utilization - specifically emergency department (ED)~     visits and diabetes-related hospitalizations.~   "
14706|NCT03374449|"~     More than 200 million major surgical procedures are performed annually worldwide. Many of~     these patients have comorbidities including hypertension and/or heart failure. Chronic~     treatment of hypertension and/or heart failure very often includes a Renin-Angiotensin System~     (RAS) inhibitor (Angiotensin-Converting Enzyme Inhibitors (ACE-Is) or Angiotensin Receptor~     Blockers (ARBs). To stop or not to stop these medications before major surgery remain~     unknown. Data on management of RAS inhibitors before major surgery and anesthesia remain~     lacking and matter of debate. It is much likely that the strategy regarding management of RAS~     inhibitors in the peri-operative setting have important impact on peri-operative~     complications.~      The lack of evidence leads to conflicting guidelines with respect to RAS inhibitors~     management before major surgery. While French guidelines are to stop RAS inhibitors patients~     with hypertension to avoid profound anesthestic-drugs-induced hypotension, international~     guidelines differ. The American heart association task force states that continuation of RAS~     inhibitors perioperatively is reasonable (class IIa recommendation,level of evidence: B). The~     purpose of this study is to determine the prognostic impact of withholding vs continuing ARBs~     before major non cardiac surgery.~   "
14710|NCT03374384|"~     This study will be carried to:~        1. Describe the pattern of seizures among cases admitted to Pediatric department at~          Al-Arish central hospital in North Sinai and compare results with national and~          international similar studies .~        2. Provide the basic descriptive information that is necessary for planning future studies.~   "
14712|NCT03374358|"~     This study will provide data on the switch from a protease inhibitor or efavirenz to the new~     formulation of raltegravir (RAL) dosed once daily. The study group consists of patients with~     metabolic risk factors and co-morbidities, in need of optimization of their current ART to~     minimize the drug-related metabolic side effects as standard of care.~      The primary objective of this study is to investigate whether switching a protease inhibitor~     (PI) or efavirenz to raltegravir once daily reduces liver fat in patients who are overweight~     or obese and have at least one metabolic syndrome component. For this purpose, the liver fat~     content will be analyzed using the proton magnetic resonance spectroscopy.~      In addition, the aim is to clarify the change in the body composition and metabolism in this~     study group. For this purpose the visceral adipose tissue (VAT) and subcutaneous adipose~     tissue (SAT) volumes will be measured and subcutaneous tissue samples will be collected for~     future analyses of adipose tissue function.~   "
14713|NCT03374345|"~     Gachon University, Gil Oriental Medicine Center~   "
14714|NCT03374332|"~     This study includes patients with relapsed acute leukemia who have previously been treated~     with standard treatment that is still present and there is no curative treatment option~     available. Researchers are studying whether the drug Gemtuzumab Ozogamicin, followed by an~     infusion of blood cells called leukocytes from a donor, can stimulate the immune system to~     potentially fight the leukemia. Gemtuzmab ozogamicin is a class of drugs known as an antibody~     drug conjugate. The drug is given on days 1,4,7. It is infused, attaches to cells with a~     certain marker on the surface (the majority of which would be leukemia cells). The drug is~     then internalized and the chemotherapy drug becomes activated. Gemtuzumab is currently FDA~     approved for the treatment of acute myeloid leukemia.~      The infusion of leukocytes to stimulate the immune system to fight your leukemia is~     investigational and has not been proven to cure cancer. This combination of Gemtuzumab~     Ozogamicin and donor leukocytes is not an FDA approved treatment and is investigational.~      Initially a total of 6 patients will be included in the study to assess the safety of the~     treatment. Once 6 patients have been treated and no unacceptable toxicities are seen, more~     patients will be enrolled. The study will treat up to 18 patients on the study.~   "
14715|NCT03374319|"~     The hypothesis of this research protocol is that the investigators will be able to redesign~     the manner in which lower limb amputations are performed so as to include biological~     actuators that will enable the successful employment of next generation lower extremity~     prostheses. The specific aims of the project are as follows:~        1. To develop a standardized operative technique for both above knee and below knee~          amputations that includes a somatotopically organized arrangement of innervated~          biological actuators~        2. To assess the capacity for these actuators to provide enhanced motor control and sensory~          feedback~        3. To determine the reinnervation time course and longevity of these biological constructs~   "
14716|NCT03374306|"~     Our project is a 24-month longitudinal randomized controlled trial that aims to investigate~     the myopia development after topical application of 0.01% atropine in children with either~     fast or slow myopia progression classified according to their initial electro-retinal~     responses. This will help elucidate the effectiveness of using low concentration atropine for~     myopia control in children with different myopia progression rates.~   "
14717|NCT03374293|"~     The objective of this study is to evaluate the efficacy and safety of radiation therapy~     combined with anti-PD-1 antibody in patients with pancreatic cancer~   "
14718|NCT03374280|"~     To investigate the curative effect between Pemetrexed/Cisplatin and Pemetrexed/Cisplatin~     intercalating Gefitinib Treating EGFR Wild NSCLC~   "
14719|NCT03374267|"~     The purpose of the project is to set up a national, prospective, longitudinal, multicenter~     cohort study with associated satellites, a tumor registry platform, to document uniform data~     on characteristics, molecular diagnostics, treatment and course of disease, to collect~     patient-reported outcomes and to establish a decentralized biobank for patients with advanced~     Renal Cell Carcinoma in Germany.~   "
14720|NCT03374254|"~     The purpose of this study is to determine safety and tolerability and to establish a~     preliminary recommended Phase 2 dose (RP2D) for the following combinations: pembrolizumab~     plus binimetinib (Cohort A), pembrolizumab plus mFOLFOX7 (oxaliplatin 85 mg/m^2; leucovorin~     [calcium folinate] 400 mg/m^2; fluorouracil [5-FU] 2400 mg/m^2) (Cohort B), pembrolizumab~     plus mFOLFOX7 and binimetinib (Cohort C), pembrolizumab plus FOLFIRI (irinotecan 180 mg/m^2;~     leucovorin [calcium folinate]400 mg/m^2; 5-FU 2400 mg/m^2 over 46-48 hours) (Cohort D), and~     pembrolizumab plus FOLFIRI and binimetinib (Cohort E).~   "
14721|NCT03374241|"~     Single ascending dose of HM15211 in healthy obese subjects.~   "
14722|NCT03374228|"~     Assess the absolute bioavailability of a tablet formulation of BMS-986205 following~     simultaneous oral administration of BMS-986205 and intravenous infusion of [13C]BMS-986205~     solution for intravenous administration in healthy participants.~   "
14723|NCT03374215|"~     Background:~      The adrenal gland makes the hormone aldosterone. This helps regulate blood pressure. An~     adrenal gland tumor that makes too much aldosterone can cause high blood pressure and low~     potassium. The cause of these tumors is unknown, but sometimes they are inherited.~      Objective:~      To study the genes that may cause primary aldosteronism in Black individuals.~      Eligibility:~      People ages 18-70 who:~      Are Black, African American, or of Caribbean descent~      And have difficult to control blood pressure or primary aldosteronism~      Relatives of people with primary aldosteronism~      Design:~      Participants who are relatives of people with primary aldosteronism will have only 1 visit,~     with medical history and blood tests.~      Participants with primary aldosteronism or difficult to control blood pressure (suspected to~     possibly have primary aldosteronism) will be screened with a 1 2 hour visit. If they qualify,~     they will return for a hospital stay for 7 10 days. Tests may include:~      Medical history~      Physical exam~      Blood tests: Participants will have a small tube (IV catheter) inserted in a vein in the arm.~     They may drink a glucose-containing liquid or get a salt solution. If medically indicated,~     they may have invasive blood tests with a separate consent.~      Urine tests: Some require a high-salt diet for 3 days.~      Heart tests~      Scans: Participants lie in a machine that takes pictures of the body. A dye may be injected~     through a vein.~      Small hair sample taken from near the scalp.~      Kidney ultrasound~      Bone density scan: Participants lie on a table while a camera passes over the body.~      If the doctors feel it is medically necessary, they will offer participants treatment~     depending on their results. These treatments may cure the patient of their disease and may~     include:~        1. <TAB>Having one adrenal gland removed by the Endocrine surgeon under anesthesia.~          Patients will have follow-up visits 2 4 weeks after surgery.~        2. <TAB>Taking drugs to block the effects of aldosterone~      Participants may return about 1 year later to repeat testing.~      Sponsoring Institution: National Institute of Child Health and Human Development~   "
14904|NCT03371823|"~     The purpose of this study is to investigate the role of ET-1 in mediating vasoconstrictor~     tone in hypertensive postmenopausal women (PMW) alone and in combination with a commonly~     prescribed Angiotensin II (ANG II) antagonist. The long term goal is to understand the~     mechanisms contributing to hypertension (HTN) in PMW. This study is the first step in~     reaching our goal.~   "
14724|NCT03374202|"~     Background:~      The Human Immunodeficiency Virus (HIV) attacks the immune system. Scientists have created a~     gene that could be transferred to the cells of people with HIV. The gene should tell the~     cells to make an antibody called VRC07. This antibody fights HIV. The VRC07 gene is packaged~     into a man-made version of a virus called AAV8.~      Objectives:~      To see if AAV8-VRC07 is safe. To study if it causes cells to produce the VRC07 antibody.~      Eligibility:~      Adults ages 18 - 60 who are HIV infected but in general good health and have been taking the~     same HIV medicine for at least 3 months~      Design:~      Participants will be screened in a different protocol.~      Participants will get the study product on Day 0. It will be injected one or more times in~     the upper arm or thigh using a needle. Participants weight will be measured to calculate the~     dose.~      Women may have a pregnancy test.~      For 7 days after getting the study product, participants will check their temperature with a~     thermometer. They will note any symptoms in an electronic or paper diary.~      Participants will have study visits. At each one, they will have a physical exam and medical~     history. They will have blood drawn and may have saliva collected.~      The visit schedule will be:~      For 12 weeks: 1 visit a week~      For the next 12 weeks: 1 visit every other week~      Then about 1 visit a month~      After 1 year in the study: a visit every 6 months for the next 4 years.~      Total study participation is 5 years.~   "
14725|NCT03374189|"~     This study aims to evaluate the efficacy and safety of a novel port-site closure device (EZ~     Close) by comparing it with the Carter-Thomason device.~   "
14726|NCT03374176|"~     Periodontitis is an inﬂammation of the supporting structures of the teeth, usually caused by~     speciﬁc or groups of microorganisms that results in the progressive destruction of the~     periodontal ligament and alveolar bone. the objective of periodontitis treatment is to reduce~     the number of periodontal pathogens. However, there is not an agreement in the use of~     systemic antibiotics in patients with diabetes. The purpose of the present study was to~     determine the efficacy of amoxicillin/metronidazole compared to clindamycin during~     non-surgical treatment of periodontitis in patients with type 2 diabetes mellitus.~      Patients and methods In this double-blind, randomized clinical trial, a total of 42 patients~     with chronic periodontitis and type 2 diabetes were included in a 24-months follow-up.~     Patients were randomly assigned to treatment with either amoxicillin/metronidazole or~     clindamycin every for 7 days. Clinical determinations (depth of probing, bleeding at the~     probe and plaque index) were performed to determine the extent and severity of periodontitis~     before and after the pharmacological treatment. The intra-group differences were calculated~     with Wilcoxon rank test. The inter-group differences were calculated with Mann-Whitney test.~     Sex, bacterial plaque, and bleed to the sounding were summarized using proportions and~     analyzed with the chi-square method. In all analyses, a P-value of <0.05 (two tailed) was~     considered statistically significant~   "
14727|NCT03374163|"~     To evaluate the effect ofempiricintralipidinfusion therapy on pregnancy outcomes in patient~     withunexplained recurrentimplantation failure (RIF) undergoIntracytoplasmic sperm injection~     (ICSI).~   "
14728|NCT03374150|"~     The world prevalence of obesity in adult population in 2014 was nearly 13% while in~     Indonesia, it has reached 32.9% in the same year. Obesity is an established risk factors for~     cardiovascular diseases. A large proportion of people who had succeeded to reduce body weight~     failed to maintain it (weight cycling). Studies were inconclusive about the best composition~     in the diet for such people to have a better life quality and reduce risk factors from~     non-communicable disease. The purpose of this research was to evaluate the body composition~     changes, Inflammation marker and oxidative stress marker changes resulted from low calorie~     high protein and standard protein diet programme in obese people with history of weight~     cycling.~      This is an open-randomized clinical trial of weight loss program as a part of a larger study~     researching the effect of low calorie high protein diet to body composition, oxidative~     stress, inflammation marker and metabolic syndrome in obese with weight cycling. Subjects~     were assigned to low calorie diet and were randomly distributed into two intervention groups,~     namely high protein group (22-30 % of total calories intake) and standard protein group~     (12-20%). Anthropometry, body composition data, and blood sample (for inflammation marker~     (HsCRP) and oxidative stress (malondialdehyde and glutathione)) were taken at baseline and at~     the end of the study. Subjects were followed up to 8 weeks with daily reminder and weekly~     counselling~   "
14729|NCT03374137|"~     This study aims to collect clinical data, mainly focused on safety, in the local target~     population as per the requirement of Korea Ministry of Food and Drug Safety for market~     authorization. The study population comprises patients with approved local indications~     chronic lymphocytic leukemia (CLL) and/or follicular lymphoma (FL) in routine clinical~     practice after launch.~   "
14730|NCT03374124|"~     Previous studies have demonstrated that the eosinophilic inflammation of nasal mucosa is~     associated with the uncontrolled condition of chronic rhinosinusitis after surgery. However,~     the definition of the eosinophilic chronic rhinosinusitis is not very clear. Japanese~     researchers have designed a scoring system to diagnose eosinophilic chronic rhinosinusitis.~     In this study, the investigators hope to examine the practicability of this scoring system~     and have a better knowledge of eosinophilic chronic rhinosinusitis in china.The retrospective~     study was conducted in a tertiary hospital. Participants received functional endoscopic sinus~     surgery more than 1 years were called back for evaluation. A diagnosis cut off value of~     eosinophil count was determined by the surgery prognosis. Then different factors were~     compared between participants with eosinophilic CRS and those with non-eosinophilic CRS to~     establish the appropriated diagnosis approach for eosinophilic CRS.~   "
14731|NCT03374111|"~     480 pregnant patients diagnosed of silent or standard α-thalassemia, HbH disease, minor or~     intermediate β-thalassemia with mild anemia will be randomly assigned to treatment group and~     control group. Patients in the treatment group will be given 15 g of Colla corii asini powder~     form daily for 8 weeks and followed up to 42 days postpartum while the control group will be~     observed and followed up in the same period treated with placebo. Levels of hemoglobin(Hb),~     reticulocyte (RET), immaturity reticulocyte (IRF), indirect bilirubin(IBIL), total~     bilirubin(TBIL), lactic dehydrogenase(LDH) will be measured on three visits(baseline, week 4~     and week 8). The curative effect of TCM Syndrome( week 8) and undesirable pregnancy~     outcomes(42 days after giving birth) will be observed.~   "
14935|NCT03371420|"~     This is a first in-human, open-label pilot (microdose) study of the positron-emitting agent~     124I-PU-AD in subjects with specific cancer types (solid malignancy, lymphoma, and/or~     myeloma) and/or Alzheimer's disease.~   "
14732|NCT03374098|"~     This pilot program will assess whether an enhanced PCMH model with more intensive management~     and intervention can improve chronic disease patient outcomes, improve healthcare delivery,~     and reduce healthcare costs. Participants in this program are current patients at Leland~     Medical Clinic and are either enrolled, or eligible to enroll, in Mississippi's Medicaid~     program. This pilot program will test the effectiveness of high-quality interventions~     comprising of: (1) an educational intervention focusing on chronic disease management and (2)~     home visits by a trained community outreach worker.~      This pilot program will evaluate both process measures and outcome measures. Examples of~     process measures include, but are not limited to, the number of patients enrolled in each~     intervention group, the number of educational classes attended by a unique patient, and the~     number of home visits a unique patient receives. Examples of outcomes measures include, but~     are not limited to, change in patient HbA1C levels, change in patient LDL/HDL levels, change~     in patient blood pressure (systolic and diastolic) levels, and a comparison of patient cost~     data (total expenditure, expenditures by other major categories like hospital, pharmacy,~     etc.) After baseline measurements, patient clinical values will be acquired every 3 months~     for the duration of their engagement.~      This pilot project has three specific goals:~      Goal 1: Improve healthcare delivery for chronic disease patients enrolled in Mississippi~     Medicaid.~      Goal 2: Improve clinical outcomes for chronic disease patients enrolled in Mississippi~     Medicaid.~      Goal 3: Reduce Mississippi Medicaid costs for chronic disease patients enrolled in this pilot~     program.~   "
14733|NCT03374085|"~     This is an open-label, multi-center, international, Phase 1 study to assess the safety, PK/PD~     and preliminary efficacy of CC-92480 in combination with dexamethasone in subjects with RRMM.~      All eligible subjects must be refractory to their last line of therapy and have failed, be~     intolerant to or are not otherwise candidates for available therapies demonstrated to confer~     clinical benefit to subjects with relapsed and refractory multiple myeloma including (at a~     minimum), thalidomide, lenalidomide or pomalidomide and a proteasome inhibitor.~   "
14734|NCT03374072|"~     The proposed project is an intervention development grant in which the investigators will~     develop a program to facilitate the engagement of adult siblings to work with their families~     to plan for the future of their brother or sister with autism spectrum disorder (ASD).~     Siblings FORWARD (Focusing on Relationships, Well-being, and Responsibility aheaD) will~     target common barriers to sibling involvement in family future planning, including improving~     family communication around difficult topics, increasing siblings' knowledge of and~     confidence in accessing ASD service systems, and anticipating and proactively problem-solving~     barriers to future planning. Siblings FORWARD will be implemented in a community setting.~     There are three aims of the project, and only the third aim will utilize a clinical trial.~     Aim 1: To develop the Siblings FORWARD program. The investigators will develop the Siblings~     FORWARD program in collaboration with community organizations, with input from siblings,~     adults with ASD, and community providers. Aim 2: To assess feasibility of the Siblings~     FORWARD program. The investigators will assess recruitment capability, appropriateness of~     outcome measures, acceptability of the program, and viability of the procedures and further~     refine the Siblings FORWARD Program through an open trial with 5 siblings. Aim 3: To assess~     the outcomes of participation in the Siblings FORWARD program. The investigators will conduct~     a pilot randomized controlled trial (RCT) with 36 siblings. The investigators will collect~     pre-, post-, and 3-month follow up data measuring intervention targets (problem-solving~     skills, communication skills, self-efficacy, perceived barriers to future planning, knowledge~     of services & delivery systems, knowledge of family plans), sibling behavioral outcomes~     (development & implementation of a sibling future plan of action, increased family~     communication around future planning), and proximal outcomes for the adult with ASD (unmet~     needs, quality of life, and family relationships). Siblings will be randomly assigned to the~     Siblings FORWARD (N=18) or an information only control condition (N=18). The investigators~     hypothesize that siblings who participate in the Siblings FORWARD program will have a more~     developed plan of action, gains in skills and knowledge, and improved proximal outcomes for~     the adult with ASD, compared to siblings in the control condition.~   "
14735|NCT03374059|"~     Objectives: The purpose of the study was to investigate the effects of exercise and life~     modification on pain and disability in text neck.~      Methods: Eighty-five participants were randomly divided into three groups: Exercise (n=29),~     Exercise+Life modification (n=28), and Control Group (n = 28). Pain intensity during rest,~     activity, and at night was evaluated with Visual Analogue Scale (VAS) and functional~     assessment was done by using Neck Disability Index at the beginning and at the end of 4~     weeks.~   "
14736|NCT03374046|"~     The purpose of the study is to determine the impact of apneic oxygenation on the time to~     desaturation in pediatric patients treated in a pediatric intensive care unit (PICU). The~     investigators hypothesize pediatric patients will have an increase in time to desaturation~     with apneic oxygenation when compared to standard practice in the PICU.~   "
14737|NCT03374033|"~     The aim of this study is to evaluate the effect of increasing amino acid and energy intake~     during parenteral and enteral nutrition with and without the stimulation of the infant's~     physical activity, on growth of extremely low birth weight infants .~   "
14738|NCT03374020|"~     Comparison between retinal measurements, done by the Notal-OCT imaging and a commercial OCT~     (Optical Coherence Tomography)~   "
14739|NCT03374007|"~     With open, single/ multiple dosing and dose escalation, phase I clinical trial scheme to~     evaluate safety, tolerance and pharmacokinetic properties of Genolimzumab injection in~     Chinese patients of advanced and (or) recurrent solid tumor/lymphoma~   "
14740|NCT03373994|"~     Investigators want to use 18F-FDG PET/CT imaging to reflect tumor perfusion and hypoxia.~   "
14741|NCT03373981|"~     This is an open-label clinical trial to determine the safety of rTMS and efficacy in~     improving depression symptoms, quality of life and cognition deficits among patients with~     Amyotrophic Lateral Sclerosis (ALS) and other neurodegenerative disorders.~   "
14742|NCT03373968|"~     This is an open label, long-term safety, tolerability, and efficacy study of GIVINOSTAT in~     all DMD (Duchenne's muscular dystrophy) patients who have been previously treated in one of~     the GIVINOSTAT studies.~   "
14743|NCT03373955|"~     This study is designed to evaluate the untreated NSCLC patients. After participants have~     accepted chemotherapy, radiotherapy, and immunotherapy, the investigators used the next~     generation sequence technology (NGS) to construct immune repertoire to detective variation of~     patients' immune state and to monitor patients' therapeutic effect. The investigators are aim~     to explore the novel clone sequence as potential therapy target.~   "
14744|NCT03373942|"~     Purpose: To investigate the effect of pseudoexfoliation (PEX) on choroidal thickness in~     primary open-angle glaucoma (POAG).~      Methods: This prospective, randomized study included 30 POAG patients and 30 PEX glaucoma~     patients with similar demographic characteristics, and 30 eyes of 30 healthy individuals~     comprised the control group. Macular choroidal thickness was measured using a Cirrus HD~     spectral domain optical coherence tomography (OCT) instrument.~   "
14745|NCT03373929|"~     The purpose of the STITCH study is to evaluate closure rates of clinically relevant septal~     defects, including patent foramen ovale (PFO), Atrial Septal Defects (ASD - less than 1 cm~     with redundant septal tissue), trans septal puncture sites, repair of Atrial Septal Aneurysm~     (ASA) and rate of recurrent neurologic embolic events in patients with cryptogenic stroke and~     PFO.~   "
14746|NCT03373916|"~     Amid consistently worsening suicide rates, in 2012 the U.S.Surgeon General's National~     Strategy for Suicide Prevention proposed to change the narrative about suicide prevention~     to include a focus on promoting hope and belongingness. Despite hopelessness and thwarted~     belongingness being among the most replicated risk factors for suicide, many widely~     implemented suicide prevention efforts instead emphasize the identification of acute suicide~     risk and referral to mental health treatment services. However, there are very few health~     service interventions known to reduce suicides among those identified as high risk. Those~     interventions shown to be effective have not achieved the wide scale implementation necessary~     to alter the trend of increasing suicide deaths. New interventions are needed, and one~     promising, scalable intervention with a novel approach to addressing the risk factors~     advocated by the Surgeon General is peer mentorship. A peer mentorship intervention, PREVAIL,~     has been piloted in a two-site randomized controlled trial (N=70) and is acceptable and~     feasible with enrollment of nearly half of eligible high-risk patients, mean completion of~     over 6 mentorship sessions, and 85% of sessions meeting fidelity standards for addressing the~     intended targets of hope and belongingness.~      The aims of this hybrid effectiveness-implementation study are:~      Specific Aim 1: Determine the effectiveness of the PREVAIL peer mentorship intervention for~     reducing suicide attempts and suicidal ideation among recently hospitalized adult psychiatric~     patients at high risk for suicide.~      Specific Aim 2: Examine the mechanisms of peer mentorship by measuring the effects of PREVAIL~     on potential mediators,including hope and belongingness.~      Specific Aim 3: Identify barriers and facilitators to implementation of PREVAIL.~   "
14747|NCT03373903|"~     The purpose of this study is to evaluate the efficacy, tolerability, and safety of BEZ235~     alone and in combination with RAD001 to support further development to reduce the incidence~     of respiratory tract infections (RTIs) in elderly subjects.~   "
14748|NCT03373890|"~     This study examines the effect of short burst interval treadmill training in ambulatory~     children with cerebral palsy. Half the sample will receive 20 sessions of training over 4~     weeks, while half will receive the training over 10 weeks.~   "
14749|NCT03373877|"~     This is a multicenter 2-part, Phase 1b study designed to assess the safety, tolerability,~     pharmacokinetics (PK) and preliminary efficacy of PU-H71 in subjects taking concomitant~     ruxolitinib. The first part (Dose Escalation) will employ a standard 3+3 dose escalation~     design to determine Maximum Tolerated Dose (MTD). The second part of the study (Dose~     Confirmation) will confirm the recommended Phase 2 dose (RP2D) in an expanded population.~   "
14750|NCT03373864|"~     Hip fracture is a frequent pathology, involving elderly patients with many co-morbidities ;~     therefore, post-operative morbidity and mortality is high. It is reported that~     intra-operative hemodynamics correlate with post-operative complications such as myocardial~     injury after non-cardiac surgery (MINS) or acute kidney injury (AKI) ; that is why elderly~     patients undergoing hip fracture surgery should benefit from a better hemodynamic stability.~      Low-dose hypobaric lateral spinal anesthesia with a reduced dose of local anesthetic has been~     shown to have better hemodynamic stability than conventional spinal anesthesia. It has also~     been reported that general anesthesia and conventional spinal anesthesia in elderly patients~     undergoing hip fracture surgery have the same hemodynamic effect. However, no published study~     has compared low-dose hypobaric lateral spinal anesthesia to general anesthesia with regards~     to hemodynamic effects.~      The aim of the present study is to compare the intra-operative hemodynamics of low-dose~     hypobaric lateral spinal anesthesia with that of general anesthesia in elderly patients~     undergoing hip fracture surgery.~   "
14751|NCT03373851|"~     Intravenous patient-controlled analgesia (iv-PCA) is the gold standard for the treatment of~     moderate to severe postoperative pain. It is used in more than 20% of cases after major~     surgery. Well known disadvantages of this method include the need of intravenous line~     (invasive, infection risk), the risk of pump programming error, possible delay for~     ambulation/barrier for enhanced rehabilitation programmes, and time/resource demanding (the~     need of preparation and installation). Sublingual sufentanil based PCA (Zalviso®) addresses~     cited issues. The safety and analgesia efficiency of this system is well described. However,~     the usability and satisfaction of Zalviso® varies depending on clinical settings. The goal of~     this study is to evaluate the usability and satisfaction of patients, nurses, and physical~     therapists using Zalviso® System during the first 72 hours in the settings of Enhanced~     Recovery After Surgery protocol after major interventions associated with moderate to severe~     postoperative pain.~   "
14752|NCT03373838|"~     The main object is to identify and understand why some hospitalized aged patients oppose~     himself to treatment or diagnosis procedure. This mixed study will used a census in a~     geriatrics department and a qualitative research.~   "
14753|NCT03373825|"~     The research team will enroll 100 young adults who use cocaine, heroin, inject drugs, or~     purchase prescription medications on the illicit market in a pilot study to be known as the~     Rhode Island Young Adult Prescription and Illicit Drug Study (RAPIDS). Participants will be~     trained to use a take-home home rapid drug test to test for the presence or absence of~     fentanyl in their drug supply. Half of the enrolled participants will be asked to test their~     urine for presence or absence of fentanyl, and the other half will be asked to test their~     drug residue for presence or absence of fentanyl. All participants will receive up to 15~     take-home rapid drug tests for fentanyl. A follow-up survey will examine and compare~     utilization of the tests between the two groups. The study will be guided by the~     information-motivation-behavioral skills (IMB) model of engagement in health behaviors. The~     IMB model hypothesizes that if a person possesses the information, motivation, and behavioral~     skills to act, there is an increased likelihood that she/he will fulfill and maintain the~     desired behaviors (behaviors that will reduce accidental overdose).~   "
14774|NCT03373552|"~     Clopidogrel non-responsiveness is probably multifactorial; several genetic and non genetic~     factors may contribute to impaired platelet inhibition by clopidogrel. In this regard, it is~     meaningful to determine genetic polymorphisms contributing to the variability of clopidogrel~     response in patients with Coronary Artery Disease (CAD). In fact, the recognition of these~     factors might predict the exposure to the risk of thrombosis and cardiovascular death in~     these patients. Therefore, the goal of this study is to determine the impact of the~     polymorphisms, affecting CYP2C19, ABCB1, PON1 and P2RY12 genes, on the response to~     clopidogrel in patients with CAD.~   "
14754|NCT03373812|"~     Involutional ptosis is a known eyelid pathology in which the eyelid margin obscures part of~     the visual axis (MRD1).Patients usually complains of visual field disturbance, deterioration~     in quality of life and a poor cosmetic appearance.~      In clinical practice, two main surgical approaches are performed to the repair of~     involutional ptosis:~        1. anterior approach - skin incision and levator muscle insertion advancement.~        2. posterior approach - eyelid reversion and tarsectomy Both approaches has its pro's and~          con's, but to this date, no solid evidence exists to prove which of these techniques is~          superior in manner of anatomical and functional results.~      in this prospective study, patients with involutional ptosis will be randomized to each of~     surgical approaches groups, parameters concerning surgical and post surgical periods will be~     evaluated.~   "
14755|NCT03373799|"~     The aim of this study was to investigate the efficacy of the video-based rehabilitation~     program on pain, functionality and quality of life in the conservative treatment of partial~     tears of the rotator cuff whether it was as successful as the physiotherapist-supervised~     rehabilitation program.~   "
14756|NCT03373786|"~     This is a Phase 1, open-label, multi-center study of the safety, pharmacodynamics, and~     pharmacokinetics of RG-012 administered to subjects with Alport syndrome.~   "
14757|NCT03373773|"~     The purpose of this study is to evaluate the patient satisfaction with voiding assessment~     remotely after removal of Foley catheter at home by the patient or her caregiver compared to~     removal at the office by a healthcare provider in patients who have been diagnosed to have~     voiding difficulty after pelvic reconstructive surgery.~   "
14758|NCT03373760|"~     This phase II trial studies how well durvalumab and tremelimumab works in treating patients~     with stage IV lung cancer that has come back after previous treatment. Monoclonal antibodies,~     such as durvalumab and tremelimumab, may interfere with the ability of tumor cells to grow~     and spread.~   "
14759|NCT03373747|"~     Introduction: The isokinetic dynamometer, considered a gold standard tool for physical~     evaluation, is widely used in studies that aim to evaluate the reliability and~     reproducibility of localized muscular endurance (LME) tests. However, such tests may not~     represent full LME by fixing time or number of replicates. Therefore, it is relevant to~     construct a test that respects the actual capacity of each subject to withstand fatigue and~     to submit such a test to validation, as well as to physiological analysis.~      Research objectives: To assess the inter- and intra-rater reliability of a localized~     isometric endurance test (IET) on the isokinetic dynamometer and to establish the metabolic~     demand required during the test.~      Design: Reliability study with test-reteste dynamic.~      Participants and Setting: After fulfilling the eligibility criteria, eighty-eight male~     participants will participate in the study.~      Procedure: In phase 1 forty-eight participants will submitted to reliability of the IET~     within three sessions: familiarization session, test session and retest sessio. In phase 2~     forty participants will be submitted the metabolic demand required during the IET will be~     analyzed by means of gas analysis, blood lactat concetrate and muscular activation~     percentage.~      Intervention: isometric endurance teste.~      Measurements: The measurements include time of execution of test, work of test, physiological~     and psychological outcomes.~   "
14760|NCT03373734|"~     A feasibility study evaluating how acceptable women experiencing low mood or anxiety during~     their pregnancy find an online Cognitive Behavioural Therapy course called 'Enjoy Your Bump'.~     This project will also begin to explore the effectiveness of this programme as a low~     intensity self-help intervention for mild to moderate depressive symptoms during pregnancy.~   "
14761|NCT03373721|"~     The aim of this study is to obtain a longitudinal view of the gut microbial establishment of~     a cohort of 51 preterm (PT) infants compared to 50 full-term (FT) infants from birth to 90~     days of age, and to identify key clinical factors that affect the establishment of neonatal~     microbiome.~      The hypothesis of the investigators is that the gut microbiota progression of PT group and FT~     group is different in diversity and composition. Antibiotics and its usage duration is likely~     the main factor disturbing the colonization and development of the gut microbiome of PT~     infants.~   "
14762|NCT03373708|"~     Breast cancer is the most common female malignancy in the world, and the leading cause of~     cancer-associated mortalities among women. Hormone receptors (HR) including ER and PR are the~     main prognostic factor for breast cancer patients. Breast cancer subtype was defined by ER,~     PR, HER2 and Ki67 status since the definition of intrinsic subtypes for breast cancer. Breast~     cancer which ER are positive have less aggressive and better long-term prognoses than other~     breast cancer subtype. Luminal B1 was definited as ER Positive, PR positive <20%, or Ki-67~     ≥20% , and HER2-Negative. Although standard therapy to HR positive breast cancer is endocrine~     treatment, evidence reported that Luminal B1 breast cancers with lower PR expression are less~     sensitive to tamoxifen than luminal A breast cancers with higher PR expression, and the~     specific mechanism is not clear. We previously had a clinically analysed, and we found the~     Luminal B1 breast cancer had a significant proportion with 38%. Whether we need standard~     chemotherapy or chemotherapy based intensive endocrine therapy for those patients? In our~     research, we divided the patients with ER positive, PR negative, and HER-2 negative into two~     groups. One groups will be treated with 8 cycles of chemotherapy (EC×4-T×4). The other~     received 4 cycles of chemotherapy (TC×4) then will be given the intensive endocrine therapy~     (Goserelin acetate+Tamoxifen for young patients/Letrozole for postmenopausal patients). The~     primary endpoint is to assess disease-free survival (DFS) and overall survival (OS) in~     different regiments, the secondary endpoint is to assess the expression of female hormone~     levels. The correlation of the expression of female hormone levels with the clinical~     outcomes, so that the investigators could optimize adjuvant treatment regiment with luminal~     B1 breast cancer.~   "
14763|NCT03373695|"~     The purpose of this study is to evaluate the efficacy and safety of treatment of coronary~     in-stent restenosis by Paclitaxel-eluting balloon catheter Dissolve™ versus SeQuent®Please,~     and the reference diameter of coronary artery stenosis is 2.5mm-4.0mm and the length ≤ 26mm.~   "
14764|NCT03373682|"~     Pancreatic extracorporeal shock wave lithotripsy (P-ESWL) is recommended as the first-line~     treatment for pancreatic stones. However, how well P-ESWL performs in geriatric patients~     remains unclear. The investigators aimed to evaluate the safety and efficacy of P-ESWL for~     geriatric patients with chronic pancreatitis.~   "
14765|NCT03373669|"~     Cholera is a life-threatening disease if prompt actions are not taken. The most recent~     estimates of the global burden of cholera estimate that there are more than 1.3 billion~     people at risk. Of which, 2.86 million (range: 1.3-4.0 million) will contract cholera and~     95,000 (21,000-143,000) will die each year. A safe, effective, and affordable killed~     whole-cell oral cholera vaccine (OCV) is now being used widely to prevent cholera in areas at~     risk. This regimen demonstrated 65% efficacy retained for at least 3 years and even up to 5~     years in an endemic setting.~      The primary aim of this project is to determine changes in the vibriocidal geometric mean~     titers (GMT) in subjects who receive the second dose of oral cholera vaccine (OCV) at~     different intervals: 2 weeks, or 6 months following the first dose of vaccine. Secondary aims~     include a) vibriocidal antibody response rates in subjects who receive OCV at 2 weeks or 6~     months following the first dose of vaccine, b) age specific serum vibriocidal GMTs following~     the second dose among participants given the second dose of OCV at intervals of 2 weeks or 6~     months following the first dose of vaccine, c) GMT and antibody response rates of~     Immunoglobulin A (IgA) and Immunoglobulin G (IgG) anti-lipopolysaccharide (anti-LPS) as~     measured by ELISA following the second dose among participants given the second dose of OCV~     at intervals of 2 weeks or 6 months following the first dose of vaccine. Our hypothesis is~     that the vibriocidal GMT following the second dose, when given after 6 months will not be~     inferior to the response when the second dose is given according to the standard interval of~     two weeks.~   "
14766|NCT03373656|"~     The purpose of this study is to study on compliance, safety and effectivity of vaccination~     for children with hematologic malignancies or solid tumors and their parents.~   "
14767|NCT03373643|"~     Obstructive sleep apnea (OSA) and nonalcoholic fatty liver disease (NAFLD) are frequently~     encountered in patients with metabolic syndrome (MS). Several data suggest that OSA per se~     could be a risk factor of liver injury. Most previous studies evaluating the association~     between OSA severity and the severity of NAFLD used indirect markers of NAFLD including liver~     imaging or liver injury blood markers or have been performed in morbidly obese patients~     undergoing intraoperative needle liver biopsy during bariatric surgery.~      The current study propose to investigate with a full night polysomnography consecutive~     patients undergoing percutaneous liver biopsy for suspected NAFLD.~   "
14768|NCT03373630|"~     The Midline catheter is a peripherally-inserted catheter, with the distal tip being placed at~     or below the level of the axilla. It is a relevant alternative to other catheters in case of~     limited venous access and long-run perfusions. Moreover, another significant advantage may be~     the reduction of the risk of infection.~      However, the Midline catheter is poorly described in scientific literature, essentially~     through retrospective and meta analyses including multiple types of catheters (Piccline, CVC,~     PAC). Therefore, the TIM-GHM study aims to prospectively assess the rate of infections in~     case of the Midline catheter.~      The results of this study could bring a collective benefit in terms of knowledge and~     reliability of these intravascular devices.~      Depending on these results, a randomized, controlled study will be considered, in order to~     compare the Midline catheter to its main alternative : the Piccline.~   "
14769|NCT03373617|"~     Retrograde intrarenal surgery (RIRS) with flexible ureteroscopy is based on video monitoring~     of urinary tract during operation. Therefore, shaking vision on monitor can bother surgeons~     and make them tired. This can lead in tissue injury from lasing.~      The purpose of this study is to investigate the stability of monitoring of surgical field~     which is assessed by surgeon.~   "
14770|NCT03373604|"~     This study is being done to learn about tau tangles in Alzheimer's disease. A type of~     positron emission tomography (PET) scan is used to measure the abnormal accumulation of~     protein called tau in the brain. These are thought to be involved in Alzheimer's disease. The~     investigators will also perform brain MRI and to tests to measure the participant's memory~     and thinking.~   "
14771|NCT03373591|"~     The aim of this study is to perform a randomized controlled trial for patients undergoing~     bariatric surgery, comparing the need for opiates with and without administration of a~     transversus abdominis plane (TAP) block using the long acting local anesthetic, liposomal~     bupivacaine (Exparel®). From this study, the investigators will assess whether use of long~     acting local anesthetic can reduce the need for opiates in the bariatric population.~   "
14772|NCT03373578|"~     Preterm newborn sleep deprivation due to medical interventions and environmental~     characteristics of the Neonatal Intermediate Care Unit (NICU) can increase morbidity and~     developmental deleterious effects. The aim of this study is to test the effect of earmuffs on~     sleep pattern of preterm neonates. Prospective, randomized, controlled, crossover study~     conducted in NICU of two teaching hospitals from São Paulo, Brazil. The effect of earmuffs~     use was analyzed through polysomnography measurement during four Quiet times periods. It~     was also analyzed sleep related variables during 24 hours of the day. Preterm newborns~     characteristics and clinical characteristics were also analyzed.~   "
14773|NCT03373565|"~     Angiography is a common diagnostic and therapeutic procedure in patients with acute coronary~     syndrome (ACS). The complications are variable between mild self-limited complications to~     severe life-threatening complications which need early interventions.~      New angiographic methods are associated with variable complications. Death, myocardial~     infarction, and stroke are among major angiography complications. In addition, some local~     complications including bleeding at the site of insertion, infection, arteriovenous fistula,~     pseudoaneurysm, and thrombosis is reported after angiography.~      Radial and femoral methods are common angiographic methods. Its shown that radial method is~     associated with less complications and patients need shorter duration of hospitalization.~      Radial artery thrombosis is common complication of radial angiography. However, the~     prevalence is between 5 to 19 percent but often it is not clinically important. Risk of~     ischemia due to thrombosis is low because of blood flow in radial and ulnar and collaterals.~     In patients with incomplete palmar arch this is important and may cause ischemia.~      The aim of this study is to compare the outcomes of coronary angiography using Snuff-box deep~     palmar arch artery and radial artery in patients attending angiography center of Shahid~     Mohammadi hospital in Bandar Abbas in 2017.~   "
14797|NCT03373253|"~     The purpose of this study is to assess the participants socio-demographics and~     disease-related characteristics, naturalistic treatment patterns and the clinical, social and~     economic outcomes of routine clinical practice in the treatment of participants with~     treatment-resistant depression (TRD) in a variety of European countries.~   "
14775|NCT03373539|"~     Important developmental processes continue until the completion of 40 weeks gestation. Even~     during fetal life, intrinsic and environmental factors determine the balance between health~     and the onset and development of diseases. Thus, it is crucial to understand the mechanisms~     that regulate normal development and the pathways that contribute to disease pathogenesis.~      Neurotrophins are a family of four proteins that support the growth and survival of neurons.~     Their secretion increases during brain development, when new neurons are being formed and~     existing ones are branching to assemble complex neuronal circuits. In addition to their role~     in promoting neuron growth and development, neurotrophins are also a product of neuronal~     activity. Neurotrophins are also responsible for the maintenance of peripheral sensory~     neurons, including those in the lungs. Airway innervation is responsible for many aspects of~     lung function including the regulation of airway smooth muscle tone, mucus secretion, and~     reactivity; therefore, a physiological expression of neurotrophins in the lungs is required~     for normal lung function.~   "
14776|NCT03373526|"~     The hospitalization for hematopoietic stem cell transplantation (HSCT) impairs the physical~     functioning and functional capacity, but aerobic physical training and, more recently,~     inspiratory muscle training, have shown benefits to patients' health submitted to this~     intervention. However, is not known the effect of aerobic physical training combined with~     inspiratory muscle training in hospitalized patients for HSCT. The purpose of the study will~     be verify the safety, feasibility and effects of the training association.~   "
14777|NCT03373513|"~     robotic single site surgery (R-SSH) is a novel technique, which may be superior to~     conventional multiport hysterectomy in select patients regarding cosmesis and postoperative~     pain. We, perform a randomized trial to compare R-SSH with multiport laparoscopic~     hysterectomy with regard to the postoperative rehabilitation, cosmesis, the operational cost,~     and the perioperative morbidity.~   "
14778|NCT03373500|"~     Cardiovascular morbidity and mortality is increased in kidney transplant patients. High blood~     pressure (BP) contributes significantly to this risk and is also associated with shortened~     allograft survival. Salt reduction lowers BP in the general population and there is emerging~     data that salt reduction also effectively lowers BP in chronic kidney disease (CKD). Kidney~     transplant patients, by definition have CKD, but they differ fundamentally from the general~     CKD population in that they are on medications which can predispose to high blood pressure,~     their kidneys are denervated, and they often have reasonable excretory kidney function.~      The proposed study will be an eight-week randomised, controlled trial assessing the effect of~     intensive dietary salt advice on cardiovascular risk factors in kidney transplant patients.~     The primary outcome is office BP readings, with the effect on 24-hour ambulatory blood~     pressure, proteinuria, arterial stiffness and endothelial function being studied as secondary~     outcomes.~   "
14779|NCT03373487|"~     Many patients with primary brain tumors experience cognitive deficits and cognitive~     rehabilitation programs aim to alleviate these deficits.The cognitive rehabilitation program~     developed by the investigators proved effective in a large randomized controlled trial (RCT).~     To increase its accessibility, it was converted into the iPad-based cognitive rehabilitation~     program ReMind, which incorporates psychoeducation, strategy training and retraining. A pilot~     study and a randomized controlled trial are conducted, to evaluate the feasibility of the use~     of the program and the efficacy of the program in brain tumor patients after resective~     surgery.~   "
14780|NCT03373474|"~     The purpose of this study is to clarify whether local-distal point association is more~     effective than local point association by warm acupuncture in the management of breast cancer~     related lymphedema.~   "
14781|NCT03373461|"~     Efficacy and safety of LNP023 in IgAN patients~   "
14782|NCT03373448|"~     By each clinician participating in the study; 40 patients (20+20) diagnosed with mild to~     moderate peri-implantitis, defined as 2-4 mm peri-implant bone loss, will be randomized to~     either test treatment with Labrida BioClean® or control treatment with titanium curettes. In~     total 240 patients (120 test and 120 controls) treated by 6 clinicians at 6 centers will be~     included in the study.~   "
14783|NCT03373435|"~     This clinical study will evaluate whether taking an investigational drug called exendin 9-39~     is safe, well-tolerated, and helps to prevent low blood sugar in people who have had~     bariatric surgery and later develop a rare condition called postbariatric hypoglycemia (PBH).~   "
14784|NCT03373422|"~     Purpose of the study is to test whether study drug BAY1128688 brings relief for pain to women~     with endometriosis and if so to get a first impression which dose(s) work best.~   "
14785|NCT03373409|"~     Healthy male and female volunteers without asthma will be recruited to enroll in a single~     dose 3-way crossover study of the safety and pharmacokinetics of albuterol when administered~     using the Halix (TM) albuterol unit dose disposable dry powder inhaler (DPI) and the~     albuterol HFA (hydrofluoroalkane) MDI inhaler.~   "
14786|NCT03373396|"~     Chlordecone is known to induce liver damage in rat and mice but no data exists in human~     being. However chlordecone was used until 1993 in French West Indies for banana fields, it is~     important to test what damage can be induced now, for patients exposed. We should consider~     chlordecone as a potential cofactor of liver fibrosis. So we have chosen to compare two~     populations of chronic hepatitis B, C or alcoholic, with cirrhosis or without fibrosis due to~     active hepatitis, who had been exposed to chlordecone.~   "
14787|NCT03373383|"~     The purpose of the study is to characterize the dose-response relationship with respect to~     efficacy of Padsevonil administered concomitantly with up to 3 anti-epileptic drugs (AEDs)~     for treatment of observable focal-onset seizures in subjects with drug-resistant epilepsy.~   "
14798|NCT03373240|"~     We are proposing a small randomized clinical trial in which 100 substance users will complete~     the existing Psychotherapy Development Center (PDC) pretreatment assessment battery as well~     as a novel battery of assays to evaluate cognitive-affective functioning. After completing~     pretreatment assessments, participants will be randomized to either a (1) cognitive~     remediation program (training tasks) specifically designed to address cognitive-affective~     dysregulation or (2) control tasks (verbal fluency tasks). Tasks will be completed twice per~     week for 4 weeks, after which assessment batteries will be repeated. Finally, we will~     evaluate real-world behavior and the durability of the training via a one-month follow-up,~     which will include assessment of substance use as well as the cognitive-affective battery.~   "
14788|NCT03373370|"~     Peripheral neuropathies are diseases that affect the nervous system outside the brain and~     spinal cord, their prevalence is 1% in the general population, the causes are extremely~     varied with more than 200 identified causes; the main ones are diabetes, excessive alcohol~     consumption and chemotherapy. They may be sometimes disabling but generally preserve~     autonomy.~      Transthyretin amyloidosis is a rare multisystematic hereditary disease with autosomal~     dominant transmission. They present usually as a peripheral neuropathies (FAP). They are due~     to a point mutation of the transthyretin gene (chr 18q). FAP is secondary to endoneurial~     amyloid deposits and are characterized by a slowly progressive sensory, motor and autonomic.~     FAP is the most severe hereditary polyneuropathy of the adult are irreversible and fatal~     within 5 to 12 years from onset.~      Most frequent mutation of TTR gene is located on the second exon; but more than 100 mutations~     have been reported.~      Prevalence of FAP is 1 per 1 million inhabitants. They have been reported until 1990s' in~     four endemic areas North of Portugal, Sweden, Japan and Majorca. In these areas, diagnosis is~     facilitated because of the stereotypical presentation : a length-dependent polyneuropathy~     with predominant involvement of thermal and pain sensations and autonomic dysfunction, early~     onset in the third decade and a predominant Met30 TTR mutation. Positive family history is~     frequent 85% (one of the parents is affected). Diagnosis requires detection of TTR mutation~     by molecular biology (blood sample) and characterization of amyloid deposit on labial~     salivary gland biopsy.~   "
14789|NCT03373357|"~     The MAPA is the reference method to estimate the PA during the SAHOS. The MAPA can be~     recommended over 48 hours: indeed, the PA falls at the beginning of every apnea then~     increases gradually up to a pressif peak arising at the time of the ventilatoire resumption.~     These variations arise under the influence of 4 stimulus: the désaturation in O2, the rise of~     the PaCO2, the increase of the respiratory effort and the microawakening of the end of apnea~     who are at the origin of a sympathetic stimulation.~      Consequently a better diagnostic approach of the HTA (confirmation of a resistant HTA, an~     identification of the masked HTA and the patients  not dipper  by the MAPA), the~     identification of the SAHOS, and a better coverage) of the associated cardiovascular risk~     factors are essential and establish a stake in public health.~      To investigator's knowledge, no datum or study on the association HTA-SAHOS and its~     consequences was until then realized in the French overseas departments.~   "
14790|NCT03373344|"~     This study will test the effectiveness of an emotional processing intervention in individuals~     with MS in a double blind placebo controlled randomized clinical trial. We will utilize an~     intervention which has been successfully used in other populations, including Schizophrenia~     and Traumatic Brain Injury. Our pilot data shows that this intervention is effective in~     individuals with MS as well~   "
14791|NCT03373331|"~     The current project will examine the impact of an emotional processing intervention on~     emotional processing abilities in a sample of 50 persons with moderate to severe TBI. Outcome~     will be assessed across 3 domains. We will document changes resulting from treatment: (1) in~     emotional processing tasks (2) in other areas of function including QOL, social functioning,~     mood and cognition that are also likely to be impacted (3) in brain structure and function.~     The examination of efficacy in the above three areas will further our knowledge of emotional~     processing deficits in TBI and more importantly, identify an effective means of treating such~     deficits.~   "
14792|NCT03373318|"~     Acute renal dysfunction associated with cardiac surgery (DRA-ACC) in our hospital population~     affects 39% of patients, being an important cause of morbidity and mortality, increasing the~     need for dialysis and assuming a prolongation of stay in the unit of intensive care, as well~     as an increase in the economic cost.~      In this sense, extracorporeal circulation (CPB) is a clear aggression for renal function due~     to multiple effects, not entirely known.~      Human albumin is sometimes used as part of the priming of the CEC circuit in variable~     concentration according to published centers and studies, demonstrating benefits on the~     maintenance of plasma oncotic pressure during the period of ECC, as well as other effects~     that can protect renal function during this period of renal injury.~      Despite the use of albumin in the ECC priming both in Spain and in other countries, there are~     currently no published studies demonstrating the effect of albumin on renal function~     administered during CPB in cardiac surgery during the postoperative period. with a high~     incidence of kidney injury, although there are current studies that confirm a decrease in the~     incidence of kidney injury in patients with hypoalbuminemia and who undergo heart surgery~     without extracorporeal circulation.~      The hypothesis of this study is based on the potential protective effect of albumin on renal~     function in patients undergoing heart surgery under CPB, in which there is a high incidence~     of postoperative hypoalbuminemia.~      This study aims to obtain information about the effect that albumin can have in this~     population of patients with a high incidence of acute renal dysfunction, and if this benefit~     exists, whether it is significant or not to justify its systematic use.~   "
14793|NCT03373305|"~     This phase I trial studies the side effects and best dose of lenalidomide when given together~     with brentuximab vedotin in treating patients with T-cell lymphomas that have come back or do~     not respond to treatment. Monoclonal antibodies, such as brentuximab vedotin, may interfere~     with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as~     lenalidomide, work in different ways to stop the growth of cancer cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. Giving~     brentuximab vedotin and lenalidomide may work better in treating patients with T-cell~     lymphomas.~   "
14794|NCT03373292|"~     This is a prospective, randomized, single-center clinical study aiming to explore the safety~     and efficacy of venous stenting for patients with internal jugular vein stenosis (IJVS).~   "
14795|NCT03373279|"~     Patients with marginal physiologic reserve, severe frailty, and/or malnutrition may be~     regarded as unsuitable candidates for advanced cardiac replacement therapies. However, little~     data exist on precisely which measures are predictive of subsequent adverse events.~     Assessment of nutritional status and frailty is still largely predicated on crude and~     obsolete parameters, such as baseline serum albumin level or body mass index (BMI). In this~     prospective cohort study the investigators will evaluate the use of bio-electrical impedance~     spectroscopy (BIS) as a measure of body composition and assess the associations with surgical~     outcomes.~   "
14796|NCT03373266|"~     Our primary goal is to investigate any hidden burden upon the grafted kidney from the~     increase of serum fluoride resulted from sevoflurane, versus isoflurane.~   "
14800|NCT03373214|"~     Na-GST-1 is a protein expressed during the adult stage of the Necator americanus hookworm~     life cycle that is thought to play a role in the parasite's degradation of host hemoglobin~     for use as an energy source. Vaccination with recombinant Na-GST-1 has protected dogs and~     hamsters from infection in challenge studies. This study will evaluate the safety and~     immunogenicity of administering Na-GST-1 with or without the CpG 10104 immunostimulant to~     healthy Gabonese adults living in an area of endemic hookworm infection.~   "
14801|NCT03373201|"~     The aim of this study is to investigate tasimelteon vs. placebo on sleep in healthy~     individuals after a phase advance in jet lag type insomnia.~   "
14802|NCT03373188|"~     This randomized phase I trial studies how well anti-semaphorin 4D (anti-SEMA4D) monoclonal~     antibody VX15/2503 with or without ipilimumab or nivolumab work in treating patients with~     stage I-III pancreatic cancer that can be removed by surgery or stage IV colorectal cancer~     that has spread to the liver and can be removed by surgery. Monoclonal antibodies, such as~     anti-SEMA4D monoclonal antibody VX15/2503, ipilimumab, and nivolumab, may interfere with the~     ability of tumor cells to grow and spread.~   "
14803|NCT03373175|"~     Evaluation of high intensity NIMV in terms of physiological parameters has been performed in~     short-term studies in COPD patients. However, the support pressure levels used in exacerbated~     patients seem contradictory and the muscular unloading levels are uncertain. The objective of~     study is to determine the discharge level of the inspiratory musculature reached at the same~     pressure support (PS) values in a group of hospital and domiciliary ventilators. Patients~     with COPD in at least 6 months of treatment with home NIMV and in stable phase of their~     disease will be included. Eight commercial ventilators will be used, each patient will use 2~     different ventilators. A 5 minute record will be taken at baseline (without NIMV).~     Subsequently, 5 minutes in NIMV in 3 levels of PS (15/10/20) for each ventilator (15/10/20)~     and patient with EPAP of 5 cmH2O will be recorded. The results will be compared between the~     different ventilators and PS values using a general linear model for repeated variables to~     determine the differences between ventilators and PS levels of respiratory muscular unloading~     in COPD patients~   "
14804|NCT03373162|"~     The injection of BOTOX into peripheral muscles has been shown to have therapeutic effects in~     a growing number of indications including disorders involving skeletal muscle (e.g.,~     strabismus, blepharospasm, cervical dystonia, spasticity, cosmetic), smooth muscle (e.g.,~     bladder), glands (axillary hyperhidrosis) and nociceptive pain (e.g. migraine) (Brin. 2014).~     Recently, several studies have suggested that peripheral BOTOX injections in the region of~     the glabellar lines (muscles around the eyes) may be effective in treating major depression~     and chronic migraine. However, the mechanism underlying the effect of peripheral BOTOX~     injections on the brain is not well understood. Therefore, the Investigators propose to~     further explore the functional effects of BOTOX injections on brain in healthy controls. The~     approach will involve the measurement of brain metabolites in the brainstem using MRS as well~     as an investigation of the functioning and connectivity between regions of the brain using~     resting state MRI and high resolution fMRI.~   "
14805|NCT03373149|"~     In this study, the investigators will assess the efficacy of growth hormone co-stimulation to~     GnRH antagonist regimen in poor responders to COH for IVF.~   "
14806|NCT03373136|"~     In this randomized control trial the investigators aim to compare the bleeding complication~     between cold snaring and hot snaring polypectomy with a large sample size.~   "
14807|NCT03373123|"~     Esophageal varices (EVs) resulting from portal hypertension are a prevalent complication of~     cirrhosis with a high mortality when variceal hemorrhage (VH) occurs. Screening endoscopy for~     EVs is recommended for all patients with cirrhosis, and prophylactic treatments are proposed~     for preventing VH, which may be financially onerous. Therefore, noninvasive tools for~     diagnosing EVs and risk stratifying VH in cirrhotic patients are needed to decrease the~     number of unnecessary invasive endoscopic examinations of low-risk patients and avoid~     unneeded prophylactic treatment. This is a prospective, multi-center diagnostic trial~     conducted at 9 high-volume liver centers in China designed to determine the diagnostic~     performance of radiomics-based surrogate (rEndosc) (investigational technology) by CT imaging~     for noninvasive prediction of EVs and risk stratification of VH in patients with hepatitis B~     virus-related cirrhosis using endoscopic examinations as reference standard.~   "
14808|NCT03373110|"~     Healthy Hearts Healthy Minds: An Overview Individuals with depression are four times more~     likely to die from coronary heart disease than someone who does not have depression. At the~     same time, the risk of having a heart attack with depression is double that of individuals~     who do not have depression. Exercise, improves both depression and risk factors for heart~     disease; yet, most Americans do not exercise regularly, especially those with depression~     and/or heart disease.~      This study is important to these individuals as most of them want to exercise, but have~     difficulty finding the motivation and energy to do so, which has a substantially negative~     impact on their physical and mental health. This study will compare two empirically supported~     treatments designed to help individuals with a mood disorder at risk or with heart disease to~     increase their physical activity as objectively measured by a Fitbit (which we will provide~     to participants at no cost).~      This new study, focused on getting people moving, is funded by the Patient Centered Outcome~     Research Institute (PCORI) and involves 2 Patient Powered Research Networks (PPRNs) known as~     the MoodNetwork and the Health eHeart Alliance. With the help of patients across the country~     the Healthy Hearts Healthy Minds study team aims to be able to study the best method to get~     people to be more physically active - making them happier and healthier in the process.~   "
14809|NCT03373097|"~     The purpose of this study is to test the safety and efficacy of GD2-CART01, a CAR T cell~     treatment targeting GD2 in paediatric or young adult patients with High Risk and/or~     relapsed/refractory Neuroblastoma.~   "
14810|NCT03373084|"~     Hamstring muscle injuries are a common pathology in sports mainly present in sprint and~     acceleration sports, accounting for about 12% of all football injuries. Because of their~     frequency, risk of reinjury and financial cost, they can be considered as a public health~     problem. Improving knowledge of the pathophysiology of hamstring muscle injury appears to be~     a relevant research focus for prevention purposes.~   "
14936|NCT03371407|"~     The aim of the present project is to document the relationship between the behavioral~     deficits and the electrophysiological anomalies observed in PD patients in tasks involving~     motor adaptation to visual or mechanical perturbations.~   "
14813|NCT03373045|"~     The CHRONICLE Study is a multi-center, non-interventional, prospective cohort study of adults~     with severe asthma who do not achieve control with high-dose inhaled corticosteroid (ICS)~     therapy with additional controllers and/or require systemic corticosteroid or monoclonal~     antibody therapy. Data will be collected from the healthcare provider in a uniform manner for~     every patient enrolled using an electronic case report form (eCRF). Data will be collected~     monthly from patients via web-based surveys. Patients will be followed until study~     discontinuation or the patient withdraws from the study or death, whichever occurs first. The~     expectation is that patients will be followed for a period of at least 3 years.~   "
14814|NCT03373032|"~     Objective.To compare different therapies that employ acupuncture needles, silicon pellets and~     kinesiotherapy in patients with breast cancer submitted to taxane chemotherapy cycles.~     Methods. study will be carried out at the Oncomastology outpatient clinic of the Discipline~     of Mastology of the Department of Gynecology of the Federal University of São Paulo (UNIFESP)~     - Escola Paulista de Medicina (EPM) and the Oncology Clinic Associated Center of Oncology,~     located at Rua Gabriel Monteiro da Silva, 454. randomized clinical trial will be conducted to~     define the treatment. Patients will be allocated into three groups (Group A: Stiper, Group B:~     Acupuncture or Group C: Kinesiotherapy) who will receive treatment once a week for eight~     consecutive weeks. 93 patients will be randomized in one of the three groups, after having~     signed the Free and Informed Consent Form and agreed to participate in the project, will~     respond to the evaluation form and will be submitted to physical examination. will be~     evaluated in the first and tenth sessions.~      Keywords: Acupuncture, Breast Neoplasm, Chemotherapy.~   "
14815|NCT03373019|"~     The goal of this clinical trial is to evaluate therapeutic efficacy of Chidamide combined~     with R-GDP （rituximab/gemcitabine/dexamethasone/cisplatin）in treating Patients with relapsed~     or refractory Diffuse Large B-cell Lymphoma (DLBCL) not suitable for transplantation.~   "
14816|NCT03373006|"~     To investigate the utility of fluciclovine F 18 for evaluation for metastatic disease in men~     undergoing laser focal therapy of prostate cancer and the impact on inclusion for a focal~     therapy cohort.~   "
14817|NCT03372993|"~     This study evaluates the immunogenicity of the biosimilar rFVIIa (AryoSeven) in subjects~     receiving AryoSeven in real-life clinical practice.~   "
14818|NCT03372980|"~     Takayasu arteritis is a chronic vasculitis mainly involving the aorta and its main branches~     such as the brachiocephalic, carotid, subclavian, vertebral, and renal arteries, as well as~     the coronary and pulmonary arteries. Inflammation causes segments of the vessels to become~     narrowed, blocked, or even stretched, possibly resulting in aneurysms. The disease is very~     rare but most commonly occurs in young Asian women. However, there is a considerable lack of~     understanding of the disease mechanism of Takayasu arteritis. Initially, the disease remains~     clinically silent (or remains undetected) until the patients present with vascular occlusion.~     Additionally, many individuals with Takayasu arteritis, however, have no apparent symptoms~     despite disease activity. Therefore, biomarkers for diagnosis and monitor disease activity in~     individuals with Takayasu arteritis are needed. In this study, the investigators therefore to~     use different methods to identify new biomarkers for diagnosing or monitoring the disease~     activity in individuals with Takayasu arteritis. These biomarkers may provide valuable~     insights into the underlying biochemical processes and aid the understanding of the~     pathophysiology of this disease.~   "
14819|NCT03372967|"~     The primary objective of this study is to evaluate how implementing an innovative care model~     that provides the pharmacist access to a patient's vaccine history at the point-of-care~     impacts the pharmacist's ability to identify unmet vaccination needs and increase vaccination~     rates for routinely recommended adult vaccinations.~   "
14820|NCT03372954|"~     The aim of our prospective randomised study is to assess the efficacy of the retrograde~     application of non-selected bone marrow autologous cells concentrate (BMAC) in patients with~     heart failure with reduced ejection fraction of left ventricle (HFREF) of ischemic aetiology.~     The evaluated preparation is concentrated BMAC, obtained using Harvest SmartPReP2 technology.~   "
14821|NCT03372941|"~     More than 40% of patients presenting with acute bacterial skin and skin structure infection~     (ABSSSI) to the Barnes-Jewish Hospital (BJH) emergency department (ED) are admitted for~     intravenous antibiotics. There is growing evidence to suggest that many hospital admissions~     for uncomplicated ABSSSI due to Gram-positive bacteria could be avoided with an alternative~     treatment strategy employing newer long-acting antibiotics. Coupled with close outpatient~     follow-up, such an alternative hospital avoidance strategy has the potential to improve~     quality and value of care for patients with uncomplicated ABSSSI and optimize use of limited~     inpatient healthcare resources.~   "
14822|NCT03372928|"~     The amount of essential amino acids (EAA) necessary to maximally stimulate muscle protein~     synthesis and optimize whole-body net protein balance during caloric deprivation has not been~     determined. This study will address that gap in knowledge by examining the resting and~     post-exercise muscle and whole-body protein kinetic responses to ingesting varying amounts of~     EAA after a 5 day period of negative energy balance. This study will provide the initial~     evidence to support the development of a recovery-based food product for military combat~     rations.~   "
14823|NCT03372915|"~     Recently, basic research conducted in adults has revealed that fear extinction, or the~     weakening of a learned fear response, may be best explained by principles of inhibitory~     learning. New guidelines for the clinical practice of exposure therapy for anxiety disorders~     have arisen from research on inhibitory learning, but these guidelines have not yet been~     empirically tested in youth with anxiety disorders. The overall goal of this research is to~     investigate the acceptability, feasibility, and efficacy of conducting exposure therapy for~     anxiety disorders in youth according to clinical guidelines developed from basic research on~     inhibitory learning principles, using a pilot randomized controlled trial design.~   "
14824|NCT03372902|"~     The purpose of this study is to collect blood and tissue to help develop tests that might be~     able to detect cancer earlier. The investigator will be collecting these samples and~     reviewing test results from participants who have had an area of concern found on breast~     imaging, as well as from participants who are scheduled to have a routine breast cancer~     screening mammogram.~   "
14937|NCT03371394|"~     By bioelectrical impedance spectroscopy (BIS) association of fluid status in patients with~     valvular heart disease and cardiovascular outcome will be assessed.~   "
14825|NCT03372889|"~     The present study aims to compare caregiver satisfaction and efficacy between two modes of~     patient education materials (PEMs): media based and print based. The caregivers of patient's~     who undergo ACL (anterior cruciate ligament) reconstruction surgery and receive an On-Q~     Catheter pain block receive both a hand-out (print based PEM) and watch a short video~     (media-based PEM) describing how to care for their child's On-Q Catheter at home. Upon~     enrollment into the study, caregivers are randomly assigned to either first view the hand-out~     or the video, then complete a 10 questions standardized assessment of information that was~     presented in the PEMs. Caregivers are called the next day to assess caregiver satisfaction~     with the PEMs, which mode of PEM was more helpful to them, and how comfortable they felt~     managing their child's pain pump at home.~   "
14826|NCT03372876|"~     This study evaluated the effect of protein intake immediately after resistance exercise on~     lean mass, strength, and functional capacity gains in postmenopausal women. Participants were~     randomly assigned to protein-carbohydrate group (PC) (n=17), that ingested 30 g of whey~     protein immediately after exercise and 30 g of maltodextrin in the afternoon; and to~     carbohydrate-protein group (CP) (n=17), that ingested 30 g of maltodextrin immediately after~     exercise and 30 g of whey protein in the afternoon. Both groups performed the same resistance~     training protocol in the morning.~   "
14827|NCT03372863|"~     Automated software analysis now allows for quick estimation of cardiac output from the~     echocardiographic 5-chamber view. This study will validate the automated software method~     against pulmonary artery thermodilution and against conventional cardiac output measurement~     with echocardiography.~   "
14828|NCT03372850|"~     This study is a Randomized, Open-label, Multiple Dose, Crossover Study to Compare the Safety,~     Pharmacokinetics and Pharmacodynamics of HIP1601 (40 mg or 20 mg) to HGP1705 (40 mg or 20 mg)~     After Multiple Administrations in Healthy Male Volunteers~   "
14829|NCT03372837|"~     The purpose of this study is to determine the efficacy of SyB L-0501 in combination with~     rituximab in patients with recurrent/relapsed diffuse large B-cell lymphoma.~   "
14830|NCT03372824|"~     This is an observational study at the Obstetrical outpatient clinic at Stavanger University~     Hospital, Norway. The purpose of the study is to compare glycated albumin and glycated~     hemoglobin (HbA1c), both markers of long-term blood sugar with oral glucose tolerance test~     (OGTT). The OGTT is a screening test for gestational diabetes, a condition that increases~     risk of adverse pregnancy outcome for mother and child. The risks are reduced with good~     glycaemic control throughout pregnancy, therefore, it is important to screen for gestational~     diabetes.~   "
14831|NCT03372811|"~     A Double-Blind, Randomized, Placebo-Controlled, Parallel-Controlled, Two-Center, Phase IIb~     Clinical Trial to Evaluate the Efficacy and Safety of TC cream In Treating Patients with~     Psoriasis Vulgaris~   "
14832|NCT03372798|"~     One of the biggest limitations of the currently used percutaneous techniques for Pulmonary~     Vein Isolation (PVI) in the setting of atrial fibrillation ablation is the lack of real-time~     information about the left atrial (LA) wall thickness and about its acute changes during~     energy delivery for ablation. This makes difficult to predict the achievement of transmural~     lesions, to identify the possible causes of ablation failure and also to avoid the occurrence~     of perforation and/or other collateral damage.~      Computed tomography (CT) is a reliable technique for measurement of the LA wall thickness but~     it cannot be used during the ablation procedure and its extensive use is limited by the need~     of ionizing radiation. Preliminary data from animal studies support the accuracy of real-time~     ultrasound imaging modalities such as intracardiac echocardiography (ICE) or Intravascular~     Ultrasound (IVUS) imaging for measurement of LA wall thickness and monitoring of its acute~     changes related to catheter ablation.~      The pilot study INSIDE PVs has been primarily designed to evaluate the feasibility and~     accuracy of intravascular imaging techniques for real-time imaging of the LA wall thickness~     during AF ablation.~   "
14833|NCT03372785|"~     The purpose of this study is to investigate the effect of percutaneous coronary intervention~     (PCI) on cardiac function in multi-vessel disease patients with concurrent chronic total~     occlusion (CTO) lesion.~   "
14834|NCT03372772|"~     It has been observed that despite administration of apparently adequate thyroid hormone~     replacement in hypothyroid patients, many of them experience persistent fatigue and~     fatigue-related symptoms. Carnitine transports long chain fatty acids into the mitochondria~     whereupon the high energy source (ATP) becomes synthesized. Levocarnitine administration~     reduced fatigue related symptoms in hypothyroid patients receiving thyroid hormone~     replacement. The present study deals with alleviation of fatigue in hypothyroid patients by~     carnitine supplementation.~   "
14835|NCT03372759|"~     Vitrectomy with membrane peeling has developed to be the gold-standard in treatment of~     epiretinal membranes. Due to the possibility of vitrectomy induced cataract, in many~     ophthalmic surgical centers it has become usual to indicate combined phacoemulsification and~     vitrectomy in case of existing cataract.~      Epiretinal membranes (ERM) and pseudomaculaforamen are disorders involving the posterior pole~     of the eyeball with consecutive vision loss. ERM can be well visualized with spectral domain~     optical coherence tomography (SD-OCT). Different study groups showed that even intraoperative~     use of SD-OCT is possible.~   "
14855|NCT03372486|"~     Effective post-operative pain control can reduce patient morbidity and affect the patient~     outcome. Brachial plexus block is one of them, a popular and widely employed regional nerve~     block technique for perioperative anesthesia and analgesia for surgery of the upper~     extremity.~      Different drugs have been used as adjuvants with local anesthetics in brachial plexus block~     to achieve quick, dense and prolonged block like Morphine, Pethidine, Clonidine,~     Dexmedetomidine.~      Naloxone is opioid antagonists which could selectively block the excitatory effects of~     opioids. it release endorphins and also displace endorphins from receptor site .it also~     reduce the opioid induced side effects, such as vomiting, nausea, pruritus, and respiratory~     depression.~   "
14903|NCT03371836|"~     This study is an open label, adjunctive, proof of concept, pilot clinical trial. Pediatric~     patients with epilepsy and clinically significant anxiety will be recruited and if enrolled~     will receive active treatment, involving flexible dose titration of clobazam and will be~     monitored for a period of four months. The study will be monitored and overseen by the Johns~     Hopkins Hospital Institutional Review Board.~   "
14836|NCT03372746|"~     Background:~      Age-related macular degeneration (AMD) is the leading cause of blindness in the United~     States. Currently, there is no safe way to obtain cells from the eye to study. But~     researchers now can turn other types of cells, like skin or blood, into induced pluripotent~     stem (iPS) cells. These can be grown in a lab and turned into other types of cells, like~     cells from the eye. This will allow researchers to understand and treat diseases of the eye~     such as AMD.~      Objectives:~      To establish a bank of samples that can be changed into other cell types, such as eye cells,~     to better understand diseases such as AMD. Also to test drugs in order to treat various eye~     diseases.~      Eligibility:~      People who provided DNA samples in another protocol (07-EI-0025)~      Design:~      Participants will be screened with their data from the previous protocol. Participants with~     select genetic variants will be chosen and contacted via phone.~      Participants will have a punch skin biopsy. The skin will be washed. A numbing medication~     will be injected. A small piece of skin will be removed with a biopsy tool. The site will be~     covered with a dressing. They will receive instructions on how to care for the area. They~     will have follow-up visits if needed for clinical care for the area.~      Participants may be asked to return if their first sample did not provide enough cells for~     the lab.~      Participants sample will be developed into eye cells. The cells will be used to understand~     diseases and test new drugs.~   "
14837|NCT03372733|"~     Background:~      Omega-7 fatty acids are found in the oil extracted from certain fish and nuts like macadamia.~     Palmitoleic acid is one of the most common omega-7 fatty acids. Many studies suggest that~     this oil is good for heart health. Researchers want to find out more about these potential~     benefits.~      Objective:~      To study how oil enriched with palmitoleic acid (Omega-7 oil) affects metabolism.~      Eligibility:~      Healthy adults at least 18 years old with no known history of cardiovascular disease.~      Subjects not allergic to fish oil and fish products~      Females that are not pregnant and are not planning a pregnancy during the length of the study~      Design:~      Participants will be screened with questions about their health, medical history, and~     medicines they take.~      Participants will have 4 visits over 24 30 weeks. The visits may include:~      Blood drawn from a vein in the arm by a needle stick. Sometimes participants will have to~     fast before the blood draw.~      Vital signs (blood pressure, heart rate, and temperature) taken~      Body mass index measured~      Cardio-Ankle Vascular Index test. The stiffness of the participant s arteries will be~     measured by reading blood pressure in the arms and legs and monitoring the heart.~      Optional stool samples~      Pregnancy test~      A short review of participants physical activity and diet~      Appetite and satiety test. Participants will fast the night before, then answer questions~     about appetite and feeling full. They will get a light breakfast and then a light lunch.~      A supply of dietary supplements to take between visits. Participants will take 4 gel capsules~     a day.~      Participants will keep a food and exercise journal~      Compensation will be provided to subjects that complete the study (can we add this?)~   "
14838|NCT03372720|"~     This randomized pilot trial studies how well fractional carbon dioxide (CO2) laser therapy~     works in minimizing genitourinary syndrome of menopause (GSM) in gynecological cancer~     survivors. Fractional CO2 laser therapy may reduce symptoms of GSM in survivors of~     gynecologic cancers.~   "
14839|NCT03372707|"~     Introduction: Endotracheal intubation and mechanical ventilation are lifesaving interventions~     that are commonly done in the intensive care unit (ICU). The act of intubating someone can~     cause laryngeal edema (LE) that, if extensive enough, can cause airway obstruction after a~     patient is extubated. To date, the only test that is available to predict this complication~     is the cuff leak test (CLT). However, its diagnostic accuracy is uncertain as there have been~     no randomized controlled trials (RCT) examining this. The Cuff leak and airway Obstruction in~     Mechanically ventilated ICU patients (COMIC) Randomized Control Trial will be done to examine~     the impact of CLT on postextubation stridor and reintubation. Subsequently, describing the~     diagnostic accuracy of this test.~      Methods: This will be a multi-center centered, pragmatic, double blinded RCT. Mechanically~     ventilated patients in the ICU, who are deemed ready to be extubated will be included. All~     patients will have a CLT done prior to extubation. The results of the CLT in the intervention~     arm will be communicated to the treating physician, and decision to extubate will be left to~     the treating team, while the results of the CLT for patients in the control arm will not be~     communicated to the treating physician, and the patient will be extubated, regardless of the~     result of the CLT.~      Objective: This is a pilot trial to assess feasibility of conducting a powered RCT.~     Feasibility outcomes include: consent rate, recruitment rate, and protocol adherence.~     Clinical outcomes will include postextubation stridor, reintubation, emergency surgical~     airway, ICU mortality, in hospital mortality, duration of mechanical ventilation, and ICU~     length of stay in days.~   "
14840|NCT03372694|"~     The investigators performed a multi-centered, randomized, placebo-controlled, prospective~     clinical trial on the effect of comprehensive rehabilitation program plus chemotherapy to~     improve quality of life(QOL) and long-term survival of postoperative non small cell lung~     cancer（NSCLC）patients with high risk stages IB to IIIA. The investigators plan to enroll 354~     cases in 3 years (118 cases for chemotherapy plus rehabilitation training and traditional~     Chinese medicine (TCM), 118 cases for chemotherapy plus rehabilitation education and TCM,118~     cases for chemotherapy plus rehabilitation education and placebo), expecting that~     comprehensive rehabilitation program plus chemotherapy has a better efficacy on improving QOL~     and long-term survival.~   "
14841|NCT03372681|"~     Postoperative gastroesophageal reflux is one of the most common complications of distal~     gastrectomy. With more attention paid on it by surgeons, several new operation methods have~     been practised. Among all these, distal gastrctomy with Billroth II + Braun anastomosis was~     reported to be an useful method to decrease postoperative reflux rate. Meanwhile, the~     direction of anastomotic peristalsis has also been reported to affect the anastomosis and~     thus make difference in reflux rate. We design this study to investigate the potential effect~     and the superiority of antiperistaltic vs isoperistaltic Billroth II + Braun reconstruction~     in distal gastrectomy.~   "
14878|NCT03372161|"~     This is a research study of SP-102, an experimental medication designed to relieve pain in~     patients with a specific type of leg pain. The mediation is given once by your healthcare~     professional, with a possibility of a second injection as early as about 1 month after the~     first treatment.~      The purpose of the study is to measure how well a single injection of the experimental~     medication, SP-102, relieves pain. The study will also investigate the side effects of~     SP-102.~   "
14842|NCT03372668|"~     Massage therapy is a treatment self-reported by those with phantom limb pain (PLP) as~     moderately to extremely effective, but no research to date has been specifically designed to~     examine such efficacy or effectiveness in this regard. The investigators propose that massage~     therapy can affect PLP by applying treatment to the corresponding intact limb for amputees.~     Theoretical underpinnings of massage and mirror therapy have guided this study's development~     to address PLP through the development of a novel massage intervention.~      The proof-of-concept experimental study examines the feasibility and outcomes of a combined~     massage and mirror therapy treatment for individuals with lower limb phantom limb pain.~     Phantom pain severity, intensity, and interference were measured with visual analogue scales~     (collected twice weekly for the study's duration) and the Brief Pain Index (collected 4 total~     times across 12 weeks) using a single-subject, withdrawal design with three, 4-week study~     phases. Intervention consisted of twice weekly, 20-minute treatments for four weeks. Tailored~     treatments addressed individual phantom pain experience as if occurring on the corresponding,~     non-removed limb. Participants viewed treatment as though it were being applied to the~     amputated limb.~      Specific Aim: Determine the extent to which massage therapy applied in combination with~     mirror therapy to the intact leg of an amputee addresses PLP severity, intensity, and~     interference.~      Hypothesis: massage and mirror treatment session(s) focused on an intact limb will have acute~     and cumulative benefits (more pronounced and lasting) for PLP severity, intensity, and~     interference.~      All study activity to occur on Indiana University's IUPUI campus.~   "
14843|NCT03372655|"~     Determination of prognostic factors affecting ambulation of duchenne muscular dystrophy~   "
14844|NCT03372642|"~     Pediatric flexible flatfoot is sometimes asymptomatic but it can also cause physical~     impairment, pain, and difficulty walking. We evaluate the radiographic effectiveness of~     intervention of subtalar arthroereisis with endorthesis for pediatric flexible flatfoot with~     final follow-up at skeletal maturity.~   "
14845|NCT03372629|"~     The objective of this study is to evaluate the tolerability, safety, and pharmacokinetic of~     single- and multiple-ascending doses of ID-085 in healthy subjects.~   "
14846|NCT03372616|"~     This is a cross-sectional cohort study which aims to compare the invasive and non-invasive~     assessments on aortic blood pressure and cardiac funtion in subjects without history of~     cardio-vascular disease. Left ventricular (LV) filling pressure, LV volume, and aortic blood~     pressure will be measured invasively. Non-invasive assessment includes~     echocardiography,aortic, and carotid blood pressure measurement.~   "
14847|NCT03372603|"~     GSK2798745 is a potent and selective transient receptor potential vanilloid 4 (TRPV4) channel~     blocker being investigated for the treatment of chronic cough. This is a multi-center,~     randomized, placebo-controlled, double-blind, two-period crossover study with a purpose to~     evaluate efficacy and safety of GSK2798745. Each subject will have 2 treatment periods, and~     will be randomized to one of the following treatments in each period: A) Placebo matching to~     GSK2798745 once daily for 7 days. B) 4.8 milligrams (mg) GSK2798745 on Day 1, followed by 2.4~     mg GSK2798745 once daily for 6 days. There will be a washout period of 14 to 21 days between~     the treatment periods. A maximum of 48 subjects will be enrolled in the study and the total~     duration of participation in the study will be maximum of 10 and a half weeks including~     follow-up visit.~   "
14848|NCT03372590|"~     Premature infants are at increased risk of developing cerebral palsy (CP). Early~     interventions for at risk infants have the potential to decrease disease severity and improve~     quality of life. All infants demonstrate general movements (GMs), which are reliable~     indicators of brain function and can be reproducibly evaluated using the General Movement~     Assessment (GMA) tool.~      Prior studies have demonstrated the impact of early maternal-driven intervention strategies~     on neurodevelopmental outcomes in preterm infants. Investigators have shown that~     interventions promoting the establishment of emotional connection between the infant and his~     or her mother, including mother/infant calming sessions with scent cloth exchange, vocal~     soothing, eye contact, and kangaroo care, can impact neurodevelopmental outcomes at 18~     months. Investigators have also shown that 60 minutes of kangaroo care leads to decreasing~     levels of the stress hormone cortisol in both mothers and infants.~      This pilot study aims to determine the feasibility of a maternal-driven early intervention~     bundle in preterm infants with abnormal GMA.~   "
14849|NCT03372577|"~     Takotsubo cardiomyopathy (TC) is a type of non-ischemic cardiomyopathy in which there is a~     sudden temporary weakening of the myocardium. . In a recent study, women report more sexual~     dysfunction than men after 1 year after TC. Despite that a number of studies have assessed~     female sexual dysfunction (FSD) for TC , there is no information regarding prevalence and~     associated factors on FSD in women with TC. However, in a recent study on Iranian female~     patients with TC, more than 77% of these patients suffered from FSD. This study is aimed to~     assess the effectiveness of a Mindfulness-based Sex Therapy on Patients With TC.~   "
14850|NCT03372564|"~     Capsular REpair randomiSed controlled Trial (CREST) is a multi-center, randomized controlled~     trial with a sample size of 240 patients (120 patients in each group). The primary outcome~     measure is functional outcome as measured by the change in Hip Outcome Score at 6 months with~     secondary outcomes being hip range of motion, i-HOT 12, overall satisfaction, and VAS.~     Patients are stratified based on gender. Patients, outcome assessors, and data analysts are~     blinded to surgical allocation. Using an intention-to-treat approach, outcome analyses will~     be performed using an analysis of covariance and descriptive statistics.~   "
14851|NCT03372538|"~     comparative study between the incidence of urological injury in case of placenta accreta in~     cases where urological surgical staff are participating in the operation from the start and~     in cases where the operation is carried by the gynecological staff only~   "
14852|NCT03372525|"~     Acute respiratory distress syndrome (ARDS) in neonates has been defined in 2017.The death~     rate is over 50%. There are no special treatments for acute respiratory distress syndrome.~   "
14853|NCT03372512|"~     It is unclear to what extent systemic fluid overload has an impact on T1-mapping results by~     cardiovascular mangetic resonance imaging.~      In this study, patients will undergo body composition monitoring assessing systemic fluid~     overload and T1-mapping using MOLLI by cardiovacular magnetic resonance imaging in order to~     investigate a possible association with each other.~   "
14879|NCT03372148|"~     Examining if the use of serial pHRMi to identify biomechanical changes in the swallow~     function of HNC patients treated with radiotherapy.~   "
14856|NCT03372473|"~     Randomized controlled trial in 80 children with mild to persistent moderate asthma, who were~     randomized to receive montelukast 5mg + loratadine 5mg vs. montelukast 5mg + placebo for~     loratadine to evaluate the efficacy in terms of improvement of symptoms. Secondary outcome~     was the days off without the use of rescue medication; reduction of levels of cysteinyl~     leukotrienes (Cys-LTS), nitric oxide (FeNO), intracellular adhesion molecule type 1 (ICAM-1)~     and interleukin 8 (IL-8) in condensed exhaled air; the improvement of day and night symptoms;~     the reduction in the frequency of night awakenings; the improvement in the quality of life;~     the percentage of related adverse events; the need to use systemic steroids; the number of~     visits to the emergency department secondary to the presence of an asthma attack; the number~     of hospitalizations secondary to asthma attacks; and the improvement in the percentage of~     FEV1 in relation to the predicted.~   "
14857|NCT03372460|"~     This study will test the effectiveness of combining non-invasive brain stimulation, called~     transcranial direct current stimulation (tDCS), with virtual reality exposure as a treatment~     for Veterans with chronic posttraumatic stress disorder (PTSD). Investigators will test~     whether this intervention improves PTSD symptoms and improves quality of life. Results from~     this study may be used to develop a new non-medication approach to treating chronic PTSD.~   "
14858|NCT03372447|"~     Demonstrate the effectiveness of a single dose of a multivitamin complex for the treatment of~     megaloblastic anemia~   "
14859|NCT03372421|"~     Many people with Autism Spectrum Disorder (ASD) find the unpredictability of social~     situations emotionally distressing. It is likely that attending a diagnostic assessment is no~     exception. Social Stories are short stories that describe a social situation so that people~     know what to expect. They are written in a way that is accessible to people with ASD. This~     study will explore whether a Social Story written about a diagnostic assessment can reduce~     the associated emotional distress and increase people's satisfaction with the process. If so,~     they could be a simple way that services can better cater for their clients' needs.~   "
14860|NCT03372408|"~     In Toronto Ontario, the Parkdale Community Health Centre operates a community outreach~     program entitled Parkdale Parents' Primary Prevention Project (5P's). The 5P's provides~     weekly pre- and post-natal support and education programs for clients. This includes an~     infant feeding program for mothers with infants 0-6 months (Feeding Tiny Souls). The 5P's has~     a diverse client-base; the program is aimed at women who are in challenging life~     circumstances, therefore, clients may include low-income or single mothers and newcomers to~     Canada.~      It is important to know who is accessing community programs and what the drivers of program~     utilization are in order to better support the women who are enrolled and to target those who~     are not. The aim of this project is twofold: 1) to investigate what socio-demographic and~     psychosocial characteristics predict level of participation in a prenatal community outreach~     program targeting vulnerable mothers and 2) based on utilization of a prenatal program, are~     there differences in the use of a postnatal program? This study will be conducted through a~     retrospective chart review. The study population will consist of women who enrolled in 5P's~     prenatally. The hypothesis is that more vulnerable women will not attend programming as~     frequently.~   "
14861|NCT03372395|"~     Over recent years, a growing interest has developed in microbiota and in the concept of~     maintaining a special balance between Lactobacillus and other bacteria species in order to~     promote women's well-being. The aim of the study was to confirm that vaginal Lactobacilli~     long-lasting implementation in women with HPVinfections and concomitant bacterial vaginosis~     or vaginitis might be able to help in solving the viral infection, by re-establishing the~     original eubiosis.~   "
14862|NCT03372382|"~     Postpartum patients delivered by cesarean section will be randomized to NSAIDS Vs NSAIDS plus~     opioid~   "
14863|NCT03372369|"~     This study tests two posters that teach people about contraception: one designed by the~     Centers for Disease Control (CDC), and one designed by the researchers. The investigators~     hypothesize that the new poster will have more increased (1) contraceptive knowledge, (2)~     willingness to use effective contraception, and (3) perceived pregnancy risk than the CDC~     poster. This study will expand useful knowledge because contraceptive knowledge, willingness~     to use effective contraception, and perceived pregnancy risk have been shown to affect~     women's likelihood of using contraception. If the investigators learn how to increase these~     factors, the investigators could theoretically reduce women's risk of unplanned pregnancy.~      The investigators will test this hypothesis by recruiting N=1000 women to complete an online~     survey using Amazon Mechanical Turk. These women will complete a survey that will first~     measure their initial contraceptive knowledge, willingness to use effective contraception,~     and perceived pregnancy risk. Then women will randomly be shown one of the two posters. Then,~     the investigators will measure their contraceptive knowledge, willingness to use effective~     contraception, and perceived pregnancy risk again. The investigators will use statistical~     tests (a t-test) to find out whether there are significant changes in these three outcomes~     for either of the posters, and whether one poster does a better job of changing these~     outcomes than the other.~   "
14864|NCT03372356|"~     This is a psychosocial screening application to usual care in a cohort of neuroendocrine~     tumor patients. The application involves monitoring using the NCCN Distress Thermometer(DT),~     Hospital Anxiety and Depression Scale(HADS), Self-Perceived Burden Scale(SPBS) and~     Connor-Davidson Resilience Scale(CD-RISC). These assessments will be completed at baseline, 3~     months, 6 months, 12 months and 24 months. Patients will have the option of filling out~     questionnaires more frequently if desired.~   "
14865|NCT03372330|"~     The peripheral artery disease (PAD) prevalence is high in the elderly, the diabetic patients,~     and the patients receiving hemodialysis. To date, there is no guideline recommendation on the~     screening of PAD in patients admitted to the medical intensive care unit (MICU) for sepsis.~      We conducted a prospective cohort study focusing on patients admitted to the MICU with the~     main diagnosis of sepsis. The ankle-brachial indexes are performed within 24 hours after~     admission. Invasive arterial line monitoring and standard non-invasive measurements are~     collected. After confirmation of PAD, standard anti-platelet treatments (aspirin and~     cilostazol) are initiated. The survival before and after the conduction of this trial is~     compared to historical records. The outcomes including all-cause mortality, stroke,~     myocardial infarction, minor amputation, major amputation, and prolonged ventilator dependent~     are to be collected.~   "
14866|NCT03372317|"~     The investigators aim to use the new PET radioligand, 18F-MK-6240, to detect tau pathology in~     cognitive healthy and mild cognitive impairment (MCI) elders. The investigators will then~     examine the interactions between differential tau burden and performance on cognitive tasks,~     functional magnetic resonance imaging (fMRI) neural activation patterns, and other cognitive~     and behavioral measures. By investigating these relationships, the investigators hope to~     understand the cognitive and behavioral outcomes of tau deposition found in specific brain~     regions in cognitively normal/mildly cognitively impaired adults. Furthermore, the study aims~     to examine how the presence of tau may contribute to the risk of subsequent cognitive~     decline, neurodegeneration, and dementia.~   "
14867|NCT03372304|"~     BACKGROUND~      Orthopedic surgery can be severely painful, and peripheral regional anesthesia is highly~     recommended as part of the perioperative pain treatment. Whether catheter-based techniques~     are better than single injection techniques are debatable. Furthermore, in catheter-based~     techniques, whether a low-dose automated, periodic infusion can produce similar analgesic~     effectiveness compared to a conventional, high dose, continuous infusion has never been~     explored.~      AIM~      Comparison of the analgesic effectiveness of a low-dose automated, periodic infusion, a~     conventional continuous infusion and patient-controlled boluses only in catheter-based nerve~     blocks for patients undergoing orthopedic surgery to the foot or ankle.~   "
14868|NCT03372291|"~     This research study is evaluating the impact of a psychological intervention mobile~     application (app) on the quality of life, mood, and symptoms of patients with acute myeloid~     leukemia (AML).~   "
14869|NCT03372278|"~     This study is a multicenter, prospective, non-controlled post market clinical follow-up~     study. The objectives of this study are to confirm the safety and performance of the~     commercially available Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty.~   "
14870|NCT03372265|"~     BACKGROUND~      Total knee arthroplasty can be severely painful, and peripheral regional anesthesia is highly~     recommended as part of the perioperative pain treatment. Whether catheter-based techniques~     are better than single injection techniques are debatable. Furthermore, in catheter-based~     techniques, whether a low-dose automated, periodic infusion can produce similar analgesic~     effectiveness compared to a conventional, high dose, continuous infusion has never been~     explored.~      AIM Comparison of the analgesic effectiveness of a low-dose automated, periodic infusion, a~     conventional continuous infusion and patient-controlled boluses only in catheter-based~     adductor canal blocks for patients undergoing total knee arthrplasty.~   "
14871|NCT03372252|"~     In case of respiratory distress, patients are intubated to be connected to an artificial~     respirator to ensure gas exchanges. Before any ventilatory weaning, a breathing test in~     spontaneous ventilation under artificial nose is practiced. The patient keeps the~     endotracheal tube but is no longer assisted by the ventilator. Mortality is markedly~     increased with the prolongation of the weaning period. Despite the presence of all weaning~     criteria and the success of a breathing test in spontaneous ventilation under artificial~     nose, failure of extubation occurs in 20% of patients.~      Experimental application of an additional inspiratory load in awake healthy subjects causes a~     compensatory increase in respiratory work to maintain effective ventilation, and the subject~     does not develop hypoventilation. This respiratory drive to breathe has been demonstrated by~     quantified electroencephalography in inspiratory load tests in the form of pre-inspiratory~     negative deflections of low amplitude similar to the potential described during the~     preparation of the voluntary movement of a limb. These inspiratory pre-motor potentials begin~     about 2.5 seconds before the start of a movement in the additional motor area.~      Does the simple and noninvasive analysis of inspiratory cortical control during the~     spontaneous ventilation breath test under artificial nose predict the outcome of this test as~     well as weaning at 7 days?~   "
14872|NCT03372239|"~     This 2-part study will assess the effect of formulation and food on the pharmacokinetics of~     Indoximod in healthy volunteers. Part 1 is an open-label, 3-period, 6-sequence study.~     Participants will receive single doses of Indoximod base or salt formulation, in the fasted~     or fed state. Part 2 is a randomized single ascending dose study of indoximod salt~     formulation to characterize the PK profile and determine the safety and tolerability of each~     dose in healthy male volunteers.~   "
14873|NCT03372226|"~     The study examines the effectiveness of a computer-based self-help-program for individuals~     with problematic or pathological gambling behavior.The main objective of the study is to~     investigate the extent to which the online program leads to a significant reduction in~     pathological gambling (primary outcome), depression and gambling-specific dysfunctional~     thoughts. The program is expected to lead to a significant reduction regarding all measures~     when compared to a control group. The study is conducted as a randomized-controlled trial~     with one intervention group and one wait-list control group.~   "
14874|NCT03372213|"~     The objective of this cross-sectional study was to characterize the dietary intake of SNAP~     participants and nonparticipants by food source, including grocery stores, sit-down~     restaurants, and fast food.~   "
14875|NCT03372200|"~     FYU-981 or Febuxostat are administrated to hyperuricemia patients (underexcretion and mixed~     types) with or without gout for 14 weeks to compare the efficacy and safety of these drugs by~     the method of multicenter, randomized, double-blind, ascending dose regimen.~   "
14876|NCT03372187|"~     This project aims to determine the feasibility of delivering a comprehensive behavioral~     lifestyle intervention including dietary and exercise components via an evidence based,~     internet-delivered telehealth coaching platform. Further, investigators will gather~     preliminary data on the change in multiple sclerosis clinical outcomes and cardiometabolic~     risk factors after participation in the intervention. The outcomes will inform the design of~     a larger randomized controlled trial.~   "
14877|NCT03372174|"~     The main objective of this study is to measure the incidence of postoperative infections in 2~     groups of patients: one group of patients ventilated and one group of patients without~     mechanical ventilation during cardiopulmonary bypass for cardiac surgery, and demonstrate~     that the incidence of postoperative infections is significantly lower in patients ventilated~     during cardiopulmonary bypass.~   "
15203|NCT03367910|"~     The purpose of this study is to determine the safety and impact of fecal microbiota~     transplantation (FMT) on the fecal and urine microbiome, urine metabolome, risk of recurrent~     urinary tract infection (UTI), and persistent multidrug resistant organism (MDRO)~     colonization of patients with a history of recurrent MDRO UTIs. This is an open label phase~     1-2 study.~   "
14880|NCT03372135|"~     Postoperative cognitive decline (POCD) is a common and impactful outcome of surgical~     procedures in older adults. The pathophysiology and causative mechanisms for POCD are poorly~     understood. The robot-assisted radical cystectomy (RARC) is increasingly utilized. In~     patients undergoing RARC, Although prolonged Trendelenburg position and pneumoperitoneum can~     increase the cerebral blood flow, the excessive cerebral perfusion can lead to encephalemia,~     which reduce the oxygen uptake of brain tissue and cause insufficient oxygenation of brain~     tissue at the cellular level. POCD may take place due to cerebral hemodynamic changes. The~     goal of the current study is to investigate the combined effect of this position and CO2~     pneumoperitoneum on POCD during RARC with the monitor of cerebral oxygen.~   "
14881|NCT03372122|"~     The aim of this study is to compare the effectiveness of removal of spores and dirt from the~     skin using a single cloth bath against a cloth bath with extra rinse step, to establish~     whether the extra rinse stage will lead to the removal of a higher level of spores and dirt.~   "
14882|NCT03372109|"~     The purpose of this study is to assess the effects of repeated periods of modified fasting in~     support of healthy weight management and prevention of weight gain over the winter holiday~     period (mid-November to early January) in comparison to regular diet and activity.~   "
14883|NCT03372096|"~     Purpose: The purpose of this pilot study is to determine preliminary estimates of the~     parameters related to the distribution of the study endpoints including: International~     Prostate Symptom Score (IPSS) and quality of life (QoL) score changes, Qmax (maximum urine~     flow rate) changes, post void residual volume (PVR) changes, percent prostate infarction and~     presence of non-target embolization.~      Participants: 20 adult male subjects with benign hyperplasia will be enrolled in this study.~      Procedures (methods): This will be a multisite, open label pilot study with a small~     population undergoing an investigational intervention (prostatic artery embolization) to~     determine initial safety and potential for efficacy as measured by improvement of lower~     urinary tract symptoms (LUTS) and decrease in prostate size.~   "
14884|NCT03372083|"~     The study employs an interventional, prospective, single arm, open label, global,~     multicenter,non-randomized trial design to monitor and assess the safety profile of the~     crushed deferasirox FCT in pediatric patients between age ≥2 to <6 with transfusional~     hemosiderosis over 24 weeks. This study will aim to enroll at least 40 patients.~   "
14885|NCT03372070|"~     The aim of this pilot study is to gain information on the ability of a continuous negative~     external pressure collar to safely reduce snoring in primary snorers, and if so to determine~     whether the reduction in snoring has benefits for both the snorer and the bed partner. This~     clinical trial will involve both the snorer and his or her bed partner, both of whom must~     qualify and provide informed consent for participation.~   "
14886|NCT03372057|"~     This is a multi-center, parallel cohort, open-label, Phase 2 study of duvelisib, an oral dual~     inhibitor of PI3K-δ,γ, in patients with relapsed or refractory Peripheral T cell Lymphoma~     (PTCL).~   "
14887|NCT03372044|"~     An open-label study to understand the effect of different modified release and immediate~     release formulations on plasma PF-06865571 concentrations after single oral administration~     under fed conditions~   "
14888|NCT03372031|"~     Does active piano practice help recover hand dexterity in older adults, or does social~     interaction and music-listening alone affect motor performance? Researchers hypothesized~     improved dexterity after active piano playing, but not after passive piano listening. 15~     residents of a retirement community were partnered together and completed 2 two-week piano~     training modules. In module 1, one partner played piano exercises and songs while the other~     listened. In module 2, partners switched roles. The Purdue Pegboard Test and Box and Block~     Test assessed fine and gross motor dexterity, before, between, and after the training~     modules. A repeated measures ANOVA showed a main effect of time on overall fine and gross~     motor function, but there was no main effect of playing versus listening. Results did not~     support the hypothesis, but indicate that piano-based therapy requires greater than 2 weeks~     to begin improving dexterity and may influenced co-occurring socialization.~   "
14889|NCT03372018|"~     Evidence-based programs to prevent diabetes among high-risk individuals are less effective~     among those who also have mental health needs. This study involves developing and pilot~     testing the first adaptation of the landmark Diabetes Prevention Program lifestyle~     intervention to simultaneously treat prediabetes and elevated mental health symptoms. This~     project has large potential to impact public health, given that more than half of the U.S.~     adult population has either of these conditions, and is at risk for developing comorbid~     diabetes and mental illness.~   "
14890|NCT03372005|"~     To investigate the effect of floorball on health and performance in subjects with either type~     2 diabetes or cardiovascular diseases.~   "
14891|NCT03371992|"~     Subjects will be eligible for this study if they are about to start on a drug called~     nivolumab for lung cancer. Some patients' cancers respond to nivolumab but a majority of~     patients do not. To better determine which patients will most likely respond to nivolumab or~     not, the investigators are testing an assay that tests biopsy tissue to determine if the~     subject's tumor will likely respond to nivolumab.~      The main purpose of this research study is to see if this specialized test can help identify~     people with locally advanced or metastatic non-small cell lung cancer who are more likely to~     benefit from treatment with nivolumab. The results of the tests will not affect whether or~     not subjects receive nivolumab but may help identify future patients who are more likely to~     benefit from nivolumab. The study assay is extra and experimental.~   "
14892|NCT03371979|"~     The main purpose of this Phase 1/2 study is to determine the safety and efficacy of~     pegzilarginase in combination with pembrolizumab in patients with ED-SCLC who have relapsed~     or progressive disease on or within 6 months of platinum-based chemotherapy.~   "
14893|NCT03371966|"~     Research with young healthy individuals has shown that beetroot juice beverages that contain~     large amounts of nitrate can improve exercise performance. Currently, it is not know whether~     the consumption of beetroot juice beverages high in nitrate can improve exercise performance~     in higher functioning middle- to older-aged adults. Therefore, the purpose of this study is~     to compare the effect of two different beetroot juice beverages (one high in nitrate and one~     low in nitrate) on exercise performance in middle- to older-aged adults.~   "
15204|NCT03367897|"~     A prospective study of bleeding peptic ulcers and/or erosions in the upper gastrointestinal~     tract - risk-medication, presence of Helicobacter pylori, treatment and outcome.~   "
14894|NCT03371953|"~     Non-depolarising muscle relaxants are routinely employed to provide skeletal muscle~     relaxation during general anaesthesia (GA). Generally investigators use one or the other type~     of relaxant agent for this purpose and they are categorised based on their~     duration-of-action. Atracurium and vecuronium are two common muscle relaxant used during GA.~     They have an intermediate duration of action (around 40 minutes). Though they are effective~     relaxants and easy to reverse with reversal agents after the surgery, in case of the common~     laparoscopy procedures lasting an hour, they are relatively inefficient. There is evidence~     that when these agents are combined together (in 1:1 ratio), the duration-of-action, and~     reversibility improves. To render atracurium and vecuronium more efficient with laparoscopic~     surgery, the proposed study is aimed to evaluate the effects of combining 1/2 the respective~     standard doses of atracurium and vecuronium given together, in terms of its effect on the~     onset of block, duration-of-action, and reversibility of the neuromuscular blockade in adults~     undergoing laparoscopic surgery under GA. The study will be conducted with objective~     assessment parameter evaluation by TOF Watch SX (Organon, Teknica BV, Boxtel, The~     Netherlands), which will be used for facilitating institution, control, and monitoring the~     neuromuscular blockade during surgery. The objective of this study is to evaluate the~     additive effect of atracurium-vecuronium combination and profile its impact in patients~     undergoing laparoscopic surgery, especially in terms of increase in duration-of-action of~     muscle relaxation with the combination of drugs, when compared to respective individual~     drugs.~   "
14895|NCT03371940|"~     Program ACTIVE II is a depression treatment study sponsored by the National Institutes of~     Health, Indiana University, Ohio University and West Virginia University. The purpose of this~     study is to test the effectiveness of two forms of treatment for depression for adults with~     type 2 diabetes: talk therapy (counseling) and exercise. Both of these forms of treatment~     have been proven to be effective in helping people with depression alone. In this study, the~     investigators will test to see if both of these approaches may be more effective in helping~     people live depression-free compared to talk therapy, exercise or usual care alone.~   "
14896|NCT03371927|"~     Feeding is one of the most common problems encountered by preterm infants. Besides, effective~     and safe feeding is one of the important discharge criteria. Feeding problems of premature~     infants lead to prolonged hospitalization and increased healthcare cost. SINC feeding~     protocol was developed based on evidence-based feeding protocol (such as cue-based,~     infant-driven feeding) and individualized developmental care.~      The aim of the study is to determine the effect of the SINC feeding protocol on weight gain,~     transition to oral feeding and the length of hospitalization in premature infants according~     to traditional feeding method.~      Randomized controlled study, including 30 infants of 24-32+6 weeks gestation receiving either~     Standard Feeding or SINC Feeding Protocol.~   "
14897|NCT03371914|"~     This study seeks to measure the costs associated with HIV prevention service delivery to~     female sex workers (FSW) in Nigeria, as well as examine the relationship between management~     practices at the community-based organizations (CBOs) and costs. To complete these goals, the~     study will collect both retrospective and prospective data from CBOs and from centralized~     information from study partners (Society for Family Health, SFH). In the prospective section~     of the study, CBOs will be sampled and assigned to either treatment or control groups. Data~     collected at the CBOs will be aggregated by the CBO managers, and those in the treatment~     group will receive feedback on their performance on a monthly basis. Those in the treatment~     group will additionally receive a management training to guide their management practices.~     Researchers hypothesize that there will be improvements in management indicators and~     therefore decreases in costs at CBOs in the treatment group. Results will be disseminated to~     local, national, and international stakeholders.~   "
14898|NCT03371901|"~     After a cartilage or meniscus repair in the knee joint, the patients experience a pronounced~     and persistent decrease of knee-extension strength in the operated leg, which negatively~     affect patients' functional performance and quality of life. A possible novel exercise~     modality to increase muscle strength early is a moderate blood flow restriction with low-load~     strength training (BFR-LLST) exercise. BFR-LLST involves application of a wrapping device to~     restrict the blood flow to the muscle(s) during exercise. BFR- LLST requires much less load~     than traditional strength training and has shown to produce positive training adaptations~     such as muscle hypertrophy and strength in the lower extremity in healthy subjects and~     patients with a knee surgery. To our knowledge, early rehabilitation with BFR-LLST has never~     been investigated in a population with weight bearing restrictions, such as patients~     recovering from cartilage or meniscus repair in the knee joint. Fear of symptom exacerbation~     and adverse events have precluded BFR-LLST early after knee surgery. The purpose of this~     study is to examine the feasibility of 9 weeks of supervised rehabilitation with BFR-LLST~     early after cartilage or meniscus repair in the knee joint.~   "
14899|NCT03371888|"~     The Platelet-Rich Plasma intramuscular injections into the masseter and temporalis muscle~     were performed to reduce painful temporomandibular disorder symptoms,such as myalgia,~     myofascial pain and myofascial pain with referrals. Patients(n=120) were randomly divided~     into two groups: experimental(n=60) and control group(n=60). In controls injections with 0,9%~     NaCl were performed. Pain intensity was measured with NPRS (numeriic pain rating scale, 0= no~     pain, 11= the worst pain that one can imagine) before(0 day), during(10 day) and after(20~     day) the therapy with PRP injections. pain~   "
14900|NCT03371875|"~     This study seeks to automate the process of youth to adult transition using an existing~     computerized decision support system in primary care. Subjects will complete the TRAQ~     readiness questionnaire after the age of 14, and then their responses will be flagged for the~     physician to review and provide additional transition related educational materials. Once~     transition is necessary, the system sends an automated email to the responsible party in the~     office.~   "
14901|NCT03371862|"~     Pilot study looking at the effect on Liraglutide in the reduction of parenteral support in~     patients with short bowel.~   "
14902|NCT03371849|"~     This study is a randomized, open label, single dose, two-way crossover clinical trial to~     investigate the pharmacokinetics and safety/tolerability of HCP1102 in comparison to HGP0813~     and HGP1408 administered in healthy male volunteers.~   "
15231|NCT03367546|"~     This is a Phase II study for the use of T-cell replete reduced intensity conditioning (RIC)~     haploidentical donor allogeneic hematopoietic cell transplantation (HaploHCT) for individuals~     with high-risk non-malignant diseases who lack a suitable HLA-matched sibling donor.~   "
14905|NCT03371810|"~     Depression and obesity are very common among adolescents and young adults with~     attention-deficit/ hyperactivity disorder (ADHD). However, intervention programmes to prevent~     these comorbid disorders rarely exist. In a pilot randomized-controlled study we test two~     newly developed intervention programmes that do not involve medication: bright light therapy~     and physical exercise. Both interventions will be supported by a mobile Health application to~     monitor and feedback intervention success and booster patients' motivation.~   "
14906|NCT03371797|"~     To determine the efficacy of valsartan/amlodipine 80/5 mg once daily dose is reducing mean~     sitting systolic blood pressure (MSSBP) and mean sitting diastolic blood pressure (MSDBP)~     after 8 weeks of therapy.~   "
14907|NCT03371784|"~     Introduction: In the setting of acute ST-segment elevation myocardial infarction (STEMI)~     coronary wedge pressure (CWP) emerges as a new marker for the advanced form of pre-procedural~     microvascular obstruction (MVO), which is associated with inflammatory interstitial edema.~     Through its anti-inflammatory effects, glucocorticoid therapy may prove beneficial in~     patients with high CWP.~      Aim: To identify the presence of the advanced form of MVO before primary percutaneous~     coronary intervention (PPCI) by CWP measurement and to test the benefit of cortisol therapy,~     in terms of infarct size and left ventricular remodeling, in patients with raised CWP.~      Methods: 50 patients with a first STEMI, candidates for PPCI, with proximal coronary~     occlusion, will undergo CWP measurement followed by percutaneous revascularization. Cardiac~     MRI will be performed 3-5 days after the procedure. A cutoff for CWP in predicting MVO,~     interstitial oedema and intramyocardial haemorrhage will be derived.Based on the above~     mentioned cutoff, 180 patients with continuous elevation of the pressure line will be~     randomized, by a 1:1 model, either to cortisol therapy or to placebo. Inflammatory parameters~     will be determined from peripheral blood samples. Patients will undergo cardiac magnetic~     resonance (CMR) imaging 3 to 5 days after revascularization.~      Study endpoints: The primary endpoint will be the extent of MVO, interstitial edema and~     hemorrhage. Secondary endpoints will include infarct size, myocardial salvage, left~     ventricular volumes and ejection fraction. The clinical endpoints of all-cause and~     cardiovascular death, myocardial re-infarction, target vessel revascularization, stent~     thrombosis and stroke will be recorded at 6 months.~   "
14908|NCT03371771|"~     In response to large numbers of senior center clients who suffer untreated depression and the~     dearth of geriatric mental health providers, the investigators have simplified a Behavioral~     Activation intervention to match the skill set of age-matched lay volunteers available to~     senior centers (Volunteer BA). This R34 proposes developmental work on delivering Volunteer~     BA in senior centers, so as to arrive to a sustainable intervention with standardized~     procedures. The investigators follow with a small randomized controlled trial (RCT) testing~     the comparative impact of Volunteer BA versus MSW-provided BA on increased client activity~     and reduced depressive symptoms.~   "
14909|NCT03371758|"~     The exact mechanism of impairment of autophagy in vitiligo has not yet been determined.~   "
14910|NCT03371745|"~     The trial objective is to determine whether the deferred transfer of embryos following~     cryopreservation at the blastocyst stage following pre-implantation genetic screening~     (PGS-FET) improves live birthrates compared to both the deferred transfer of cryopreserved~     embryos without PGS (FET) and immediate transfer at the conclusion of a fresh in vitro~     fertilization (IVF) cycle (Fresh). Additionally, whether freeze-only (FET) improves live~     birth rates compared to fresh will be determined.~   "
14911|NCT03371732|"~     Despite scientific, clinical and political incentives, alcohol and/or tobacco screening and~     brief intervention (SBI) services are poorly implemented in oncology settings. Motivational~     brief interventions are recognized as particularly effective in changing health behaviors,~     especially consumption behaviors. The motivational approach is more and more used in primary~     care setting but still few studies explore its effectiveness with breast cancer patients.~      This study aims to compare two intervention arms : educational advices intervention (EAI)~     versus brief motivational intervention (BMI) for alcohol and/or tobacco consumption in breast~     cancer women, during their treatment.~      In this pilot prospective randomized trial, various psychological and behavioral, variables~     are measured (alcohol and tobacco consumption, distress, anxiety and depressive disorders,~     quality of life, motivation for change, empowerment) before the brief intervention, and after~     3 and 6 month.~   "
14912|NCT03371719|"~     This phase II trial studies how well radiation therapy with or without apalutamide works in~     treating patients with stage III-IV prostate cancer. Radiation therapy uses high energy x-ray~     to kill tumor cells and shrink tumors. Androgen can cause the growth of prostate cancer~     cells. Drugs, such as apalutamide, may lessen the amount of androgen made by the body. Giving~     radiation therapy and apalutamide may work better at treating prostate cancer than radiation~     alone.~   "
14913|NCT03371706|"~     This study will use a randomized controlled trial design to evaluate the effect of two~     evidence-based treatments for adults with mild PPA. The aim of the study is to help us better~     understand the effects of speech language therapy on communication abilities in individuals~     with PPA.~      Participants with a diagnosis of PPA and their actively-engaged care partners will be~     involved in the study for 12 months. Each participant will receive a laptop equipped with the~     necessary applications and features for the study. Participants will receive 5 evaluations~     and 15 speech therapy sessions with a licensed speech therapist, as well as access to~     Communication Bridge, a personalized web application to practice home exercises that~     reinforce treatment strategies. There are no costs to participate in this study and~     compensation will be provided.~   "
14914|NCT03371693|"~     A phase III prospective study with the primary objective to compare the efficacy and safety~     of HIPEC( Hyperthermic Intraperitoneal Chemotherapy). The target population for this study is~     patients with primary or recurrence ovarian, peritoneal or fallopian tube cancers undergoing~     CRS( Cytoreductive Surgery). Patients will be divided into two groups. Group A will undergo~     CRS plus HIPEC and then go on to receive standard platinum-based combination doublet~     intravenous chemotherapy. Group B will undergo CRS and then go on to intravenous~     chemotherapy.~   "
14915|NCT03371680|"~     Analysis of kinetics of phosphatidylcholine and specific surfactant proteins, total body~     water and water turnover in patients with acute respiratory distress syndrome (ARDS) and in~     intensive care unit (ICU) patients by using non radioactive isotopes as deuterium and~     Carbon-13.~   "
14916|NCT03371667|"~     Phase III randomized double-blinded trial designed to compare the efficacy of the addition of~     MTX to current standard acute GVHD first-line treatment with corticosteroids. The protocol~     will use a novel endpoint for benchmarking interventions based on a composite primary~     endpoint of GVHD-free and corticosteroids-free survival.~      The primary endpoint of the trial will be the assessment of a composite endpoint of~     graft-versus-host disease-free and corticosteroids-free survival at 12 months after~     randomization~   "
14917|NCT03371654|"~     This study aims to first identify the optimal estradiol (E2) dose that best engages the fear~     extinction network among healthy women using oral contraceptives. The second objective is to~     then evaluate the impact of this optimal E2 dose, when administered in conjunction with 5~     sessions of Prolonged Exposure therapy, on the functional activity of the fear extinction~     network of women with clinically significant posttraumatic stress disorder symptoms. This~     approach will elucidate the neural mechanisms underlying effective exposure treatment for~     these symptoms, and will document how estradiol could be used as adjunct to enhance the~     outcome of extinction-based therapies.~   "
14918|NCT03371641|"~     This study aims to validate that PLGF is a biomarker of cerebral lesions and therefore of~     secondary developmental disorders and disabilities that will be best diagnosed at 2 and 6~     years of age.~   "
14919|NCT03371628|"~     NTRODUCTION: cardiac surgery can lead to pulmonary complications such as hypoxemia and~     atelectasis. Noninvasive ventilation has been used to prevent and treat such complications.~     Electrical impedance tomography has been a useful tool in bedside evaluation of ventilation~     and pulmonary ventilation. OBJECTIVE: To compare the effects of non-invasive ventilation with~     oxygen therapy in cardiac post-operative patients. MATERIALS AND METHODS: It will be a~     randomized controlled clinical trial where patients will be divided into two groups: a group~     that will perform NIV for 1 hour and the group that will only use oxygen therapy. They will~     be evaluated through Electrical Impedance Tomography and arterial gasometry analysis just~     before extubation, soon after extubation, during the intervention and after the intervention~     for a period of 2 hours after extubation. EXPECTED RESULTS: It is expected that the NIV group~     will present higher pulmonary ventilation and aeration and better gas exchange than the~     oxygen therapy group, and that the time of therapeutic effect will be higher in the NIV~     group.~   "
14920|NCT03371615|"~     A randomised, controlled, double-blind trial to evaluate the tolerance and safety of a new~     partly fermented anti-regurgitation infant formula containing prebiotics and locust bean gum~     in infants with regurgitation.~   "
14921|NCT03371602|"~     The aim of this study is to study the combined impact of mechanical ventilation and sepsis on~     the human diaphragm in order to establish the neutral, protective or destructive character of~     mechanical ventilation by studying the diameter of the fibers, activation of proteolytic~     systems, inhibition of protein synthesis, tissue inflammation as well as contractile~     function.~   "
14922|NCT03371589|"~     Bell's palsy is defined as a facial nerve palsy without any other known cause. The common~     practice for this disease consists of the use of oral steroids. Such treatment can cause harm~     to people who have disabilities or prior conditions such as pregnancies, diabetes, obesity~     and/or high blood pressure. While the use of intratympanic injection for sudden sensory~     hearing loss is well rehearsed in many practices, similar management of facial nerve palsy~     due to Bell's phenomenon is rare and a few researches have been conducted regarding the~     subject. In this research we suggest intratympanic injections for these patients as a~     treatment for Bell's palsy.~   "
14923|NCT03371576|"~     Purpose: Comparison of two torical intraocular lenses with differents haptic design in~     patients with cataract.~      Methods: In this prospective, randomized clinical trial 120 eyes of 60 patients underwent~     phacoemulsification. In patient's eyes the Tecnis torical IOL (Abbott Medical Optics) or the~     AT Torbi torical 709 MB IOL (Zeiss Medical AG) were randomly implanted. Three months after~     surgery visual acuity, rotation stability and astigmatism correction were evaluated.~   "
14924|NCT03371563|"~     The investigators will focus on elderly patients with early Lyme borreliosis with the aim of~     assessing clinical course, serological response and treatment outcome of the disease as~     compared to younger adults. Furthermore, the investigators will compare the prevalence of~     nonspecific symptoms among patients and among age-matched controls without a history of Lyme~     borreliosis.~   "
14925|NCT03371550|"~     Concurrent chemoradiotherapy (CHRT) is the standard of care for unresectable locally advanced~     stage III non-small cell lung cancer. However, the optimal combination remains unclear. The~     aim of this study is to evaluate the efficacy of 2 induction chemotherapy cycles (days 1 and~     22) with docetaxel 75 mg/m2 and cisplatin 75 mg/m2 followed by concurrent chemotherapy~     (weekly docetaxel-cisplatin, 20 mg/m2) and 3-D conformal radiotherapy for 6 weeks (66 Gy/5~     fractions per week/2 Gy per fraction). ). The primary endpoint is the response rate.~     Secondary objectives are toxicity, time to progression, and overall survival.~   "
14926|NCT03371537|"~     Hepatocellular insufficiency is a dreaded complication after hepatectomy, since, if it is~     persistent, it leads to the death of the patient in the absence of liver transplantation.~      The preoperative evaluation aims in particular to estimate the risk of postoperative~     hepatocellular insufficiency so as to minimize or contraindicate high-risk patients.~      It has been shown that the flow of the portal vein is correlated with liver function,~     especially in the living donor and after portal embolization. More recently, the study of~     flow rates in the portal vein and the hepatic artery after transplantation has shown a~     correlation with the recovery of graft function.~      The hypothesis is that portal and arterial flow after hepatectomy can predict postoperative~     hepatocellular function.~   "
14938|NCT03371381|"~     The purpose of this study is to evaluate whether the efficacy of JNJ-757 combined with~     nivolumab is better than the efficacy of nivolumab monotherapy for participants with~     mesothelin-positive relapsed/refractory Stage IIIB or Stage IV adenocarcinoma of the lung.~     The open-label study comprises of two parts i.e. Phase 1b (safety run-in) and Phase 2.~     Phase1b consists of 1 arm whereas Phase 2 is randomized into 2 groups i.e. Group A and Group~     B.~   "
14939|NCT03371368|"~     The purpose of this study is to determine if diet-induced weight loss causes different~     changes in hormones that control appetite and glucose control than surgery-induced weight~     loss. The overall research plan is a non-randomized prospective study of 3 different WL~     interventions and a lean and an obese healthy control group.~   "
14927|NCT03371524|"~     CARDIAWAVE, a French start-up founded in 2014, aims to develop a new non-invasive therapy to~     treat patients suffering from Aortic Valve Stenosis (AS) who are not candidates to validated~     treatment of AS, i.e. TAVI (Transcatheter Aortic Valve Implantation) or SAVR (Surgical Aortic~     Valve Replacement). This therapy consists in focusing ultrasound on aortic valve~     transthoracically and use high energy to soften calcification from the target valve. In order~     to do so, we develop a device able to deliver high energy ultrasounds to a targeted valve~     thanks to the synchronization of patient hearts live imaging and therapy in real time.~      Live imaging will use an algorithm to realize 'valve tracking': an automatic detection of~     aortic valve position and shape as fast as image acquisition time. In order to develop and~     validate this 'valve tracking' algorithm, CARDIAWAVE requires cardiac echographic loops of~     patients with aortic valve calcification, with 30 seconds or 60 seconds recording.~      The objective of the present study is to develop and validate the 'valve tracking' processing~     algorithm of CARDIAWAVE.~      ARYEL is a prospective, multicenter, non-interventional study.~   "
14928|NCT03371511|"~     This observational study is a sub-study of the MiLC Trial (ClinicalTrials.gov Identifier:~     NCT03123874). Our objective is to characterize the bacterial communities of women's breasts,~     hands, their pump and milk collection kit, and their babies' mouths among the participants of~     the MiLC Trial. As part of the original protocol, we collected swabs of each of these areas~     from each dyad before women pumped with their own pumps. By characterizing these communities,~     we can identify from where the bacteria in human milk (HM) originates, and determine whether~     pumping with mother's own pumps enriches the bacterial communities of HM compared to pumping~     with a sterile pump.~   "
14929|NCT03371498|"~     Unresolved ARDS is defined by the persistence of ARDS criteria at the end of the first week~     of evolution despite an appropriate treatment of the cause of ARDS. A persistent ARDS is~     associated with an increased mortality and prolonged lengths of mechanical ventilation, ICU~     stay and hospitalization. Persistent ARDS is characterized by ongoing inflammation,~     parenchymal-cell proliferation, and fibroproliferation leading to disordered deposition of~     collagen. All of these pathways may be responsive to corticosteroid therapy.~      Only two randomized controlled double-blinded trials assessed the use of corticosteroids for~     persistent ARDS. In 24 patients, Meduri et al. reported an improvement of lung function and~     survival (1). In 180 patients, Steinberg et al showed no effect of corticosteroids on~     survival (2). A lower risk of death was observed when corticosteroids were started before 14~     days after the onset of ARDS (2).~      Alveolar procollagen III is validated as a biomarker of active fibroproliferation. Alveolar~     procollagen III > 9 µg/L is associated to fibroproliferation (3).~      As mortality was lower in patients who received corticosteroids while presenting a high~     alveolar level of procollagen III on inclusion, Steinberg et al. showed that patients~     presenting with a low level of procollagen III and treated with corticosteroids had an~     increased risk of death (2).~      Investigatores hypothesize that the use of procollagen III could improve personalized~     decision-making regarding steroid treatment in patients presenting with persistent ARDS. The~     future of anti-fibrotic treatment, including corticosteroids, in persistent ARDS might~     propose to individualize the therapy according to the presence of an active~     fibroproliferative phase (precision or personalized medicine).~   "
14930|NCT03371485|"~     This clinical study is looking at a vaccine called AST-VAC2 in adult patients with non-small~     cell lung cancer (NSCLC) in the advanced and adjuvant settings. The main aim of the study: If~     the dose can be given safely to patients, learn more about the potential side effects of the~     vaccine and how they can be managed and also what happens to AST-VAC2 inside the body~     (looking for effects in the blood, skin or tumour).~   "
14931|NCT03371472|"~     Paravalvular leak (PVL) is a condition that could be treated surgically or by the~     transcatheter deployment of the occluder devices (plugs).~      No PVL-specific occluder device is available on the market. VALE consortium plans to design~     and validate a new PVL dedicated devices (sizing balloon and occluder) in the context of~     computer 3D modeling, bench testing, preclinical evaluation and clinical research.~   "
14932|NCT03371459|"~     This is a randomized, cumulative dose, open-label, 2-period crossover, multi-center study to~     assess the safety, efficacy, PK, and extrapulmonary PD of cumulative doses of AS MDI compared~     to cumulative doses of Proventil as an active control in subjects with mild to moderate~     asthma~   "
14933|NCT03371446|"~     Periodontitis is related to host genetics, constitution of the dental biofilm and~     environmental factors such as smoking. DNA methylation is a mechanism of genetic expression~     that can inhibit or silence gene expression. In this way several researchers have been~     dedicated to study the genetic influence on the susceptibility and / or increased risk to~     periodontal disease. Studies have reported association between several epigenetic biomarkers~     with periodontal inflammation. Considering the hypothesis that there is an association~     between smoking and methylation in genes related to periodontal disease, the objective of~     this study was to verify the DNA methylation pattern in oral epithelial cells of patients~     with chronic periodontitis (CP) in the promoter of a specific gene involved in the control of~     inflammation, as suppressor of cytokine signaling (SOCS) 1 in smokers and nonsmokers~     patients.~   "
14934|NCT03371433|"~     Osteoporotic fractures, as a consequence of a reduced mineral bone density (BMD) represents a~     major public health problem. The lifetime risk of fractures exceeds 40% for women and 13% for~     men. At least ten different individual characteristics have already been proposed, evaluated,~     and some of them accepted as risk factors. Some of those risk factors were compiled in a tool~     developed by the World Health Organization in order to predict the ten-risk for a new~     fracture, even without considering BMD in that prediction . Increased consumption of~     carbonated soft drinks has been reported to have associations to a lower bone mineral density~     and an increment in bone fractures among young and also elder subjects.~      However, some prospective studies have not found any significant associations and others~     suggested that risk is only increased for some kinds of beverages, like cola beverages, but~     not to the entire universe of soft drinks. In this sense, a large prospective analysis~     performed on 1413 women and 1125 men from the Framingham Offspring Cohort, analyzed- the~     relation between soft drinks consumption and BMD at the spine and 3 hip sites. Cola intake~     was associated with significantly lower BMD at each hip site, but not the spine, in women but~     not in men. Similar results were observed for diet cola and, although weaker, for~     decaffeinated cola. No significant relations between non-cola carbonated beverage consumption~     and BMD were observed.~      In spite of the fact that reduced bone mineral density and osteoporotic fractures represent~     an increasing burden of disease and disability in postmenopausal women, most of the studies~     performed in this population used BMD as primary outcome, and not common osteoporotic~     fractures (e.g. hip, spine or wrist). Therefore, there is no conclusive evidence of a~     potential causal association between soft drinks (cola and non-cola) and fractures in a~     population in which osteoporotic fractures hold the highest incidence.~      This research proposal is based on using the Women Health Initiative data to analyze the~     relation between cola and non-cola soft drinks consumption on common osteoporotic fractures.~     BMD will be considered a secondary outcome.~   "
14940|NCT03371355|"~     This is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to~     evaluate the safety, including tolerability, of ISIS 703802 and to assess the efficacy of~     different doses and dosing regimens of ISIS 703802 on glucose and lipid metabolism, and liver~     fat in subjects with Hypertriglyceridemia, Type 2 Diabetes Mellitus (T2DM), and Nonalcoholic~     Fatty Liver Disease (NAFLD).~   "
14941|NCT03371342|"~     To investigate the safety of MEDITOXIN in female subjects with idiopathic overactive bladder~     compared with BOTOX~   "
14942|NCT03371329|"~     The overall goal of this study is to develop mesenchymal stem cell therapy for treatment of~     acute spontaneous hemorrhagic stroke.~   "
14943|NCT03371316|"~     The goal of this study is to demonstrate that ViaShield™ amnion patch is effective in~     preventing fibroblast activity and hence soft tissue adhesions after a hemicraniectomy.~   "
14944|NCT03371303|"~     The modifications of the medicinal treatments secondary to the hospitalizations have multiple~     reasons: reassessment of the previous treatment (conciliation), new therapeutic necessities,~     potential risk of iatrogeny or of drug interaction, restrictions of the therapeutic booklet,~     classification in reserve or hospital prescription ... These modifications are potentially~     generating extra costs for the Health Insurance and are monitored under the terms of the~     Contract of Good Use. The aims of this analysis are to define the medical-pharmaceutical~     rationale of the treatment changes imposed by hospitalization in a university-hospital~     center, their influence on the security of the medical treatment of patients and their~     financial implications for healthcare organizations~   "
14945|NCT03371290|"~     Objective: To investigate the acute effect of mirror therapy (MT) on motor control, manual~     dexterity and spasticity of the paretic upper extremity (UE) of individuals with chronic~     hemiparesis after stroke, during reaching task.~      Design: Randomized cross-over single-blinded trial. Subjects: Thirty-three patients post~     chronic stroke were recruited of the study.~      Intervention: Patients who first participated in the MT intervention performed a single~     session of MT, whereas in the control intervention a single session composed of the same~     exercises was performed, but without the mirror. After a month washout, the patients switched~     groups.~      Main measure: The primary outcome measure was motor control. The secondary outcome measure~     was manual dexterity and UE spasticity.~      The data will be expressed as mean and 95% confidence interval (continuous variable) and~     absolute frequency (categorical variables). To compare the outcomes of the different~     experimental sessions and at the different moments (pre and post session), the Generalized~     Estimating Equations with post hoc LSD (Least Significant Difference) methods will be used.~     For all analysis the significance level was set at α = 0.05 and statistical software SPSS~     (Statistical Package for Social Sciences for Mac, version 22.0, IBM, USA) will be used.~      Key words: Stroke, mirror therapy, upper extremity, kinematic analysis~   "
14946|NCT03371277|"~     Parkinson's disease (PD) is a common neurodegenerative disorder affecting 1-2% of the~     population over 65 years-old. In addition to the motor impairment characterized by resting~     tremor, bradykinesia, rigidity and postural instability, patients suffer with non-motor~     symptoms such as dysautonomia syndrome, sleep disturbances, depressive disorders, delusional~     disorders and cognitive disorders. Research and management of these non-motor symptoms is~     essential because these can be disabling and have a negative impact on the quality of life of~     patients. Among cognitive functions, social cognition is defined as the aspect that is~     dedicated to process social information for adaptive functioning. More specifically, it~     refers to an intricate set of higher-order neuropsychological domains that allow for adaptive~     behaviors in response to others. Four dimensions are usually included in this construct:~     theory of mind (ToM), emotion processing, social perception and social knowledge, and~     attributional style. Recently, different categories of social cognition have been studied in~     patients suffering from PD, such as the ToM or the recognition of facial emotions. Other~     aspects of social cognition that seem relevant in this population are still poorly studied;~     the attributional style is a cognitive bias defined as the way we explain the causes of the~     positive or negative events that occur. Indeed, different causes can be attributed to an~     event, and this attribution is shared between oneself, others and other factors related to~     the situation. People with attribution bias may mistakenly attribute to one cause all the~     situations. For example, when an individual blame the others for an event, he may develop a~     feeling of hostility that may lead to maladaptive behavior such as aggression and thus affect~     his social functioning. The impact of PD treatments, particularly deep brain stimulation~     (DBS), on the ToM has been studied, showing a deficit after stimulation. No study has~     assessed the impact of therapeutics on the attributional style of PD patients. In this~     context, it seems relevant to evaluate the effect of deep brain stimulation on the~     attributional style in this population.~   "
14947|NCT03371264|"~     A major limitation of liver transplantation is organ shortage. To avoid exposing patients to~     death on the waiting list, organs are used that would have been discarded few years ago.~     Graft allocation is regulated by the agence de biomedecine which establishes a national~     score. Each liver graft is proposed to the patient presenting the higher score. Acceptance or~     rejection of the graft only depends on the decision of each centre. We propose to submit a~     more efficient allocation model (enabling each proposed liver graft to be transplanted in the~     candidate whose transplantation will afford the greatest survival benefit after~     registration), by collecting and analysing variables from donors and candidates/recipients.~   "
14948|NCT03371251|"~     This study will be conducted to assess the safety, tolerability, and immunogenicity of repeat~     doses of BOS161721 (20 milligrams [mg], 60 mg, and 120 mg) administered subcutaneously in~     adult participants with moderately to severely active Systemic Lupus Erythematosus (SLE) on~     limited background standard of care treatment, in order to estimate the optimal dose.~      BOS161721 at the chosen dose will be compared to placebo for response on the SLE Responder~     Index 4, with sustained reduction of oral corticosteroids, in the same participant~     population.~   "
14949|NCT03371238|"~     To investigate the effect of floorball on health and performance in healthy subjects over 65~     years.~   "
14950|NCT03371225|"~     This trial aims at understanding the mechanisms of optimized transcranial direct current~     stimulation (tDCS) (16 tDCS sessions combined with exercise)] on pain control. Optimized tDCS~     can lead to stronger engagement of the endogenous pain regulatory system that will ultimately~     lead to increased pain relief in patients with fibromyalgia (FM). Therefore, the~     investigators designed a 2x2 factorial mechanistic trial [tDCS (active and sham) and aerobic~     exercise (AE) (active and control)] to evaluate the effects of 4 weeks of tDCS coupled with~     exercise on the endogenous pain regulatory system assessed by conditioned pain modulation~     (CPM) and central sensitization as assessed by temporal slow pain summation (TSPS), and~     compared to either intervention alone and to no intervention.~   "
14951|NCT03371212|"~     The aim of this study is to determine if the use of a modular dual mobility bearing is~     associated with clinically important increases in serum metal levels.~   "
20392|NCT03300063|"~     We want to determine if treating acute ischemic stroke patients who have evidence of~     hypoxemia due to sleep apnea with low flow O2 during sleep might help improve clinical and~     functional outcomes.~   "
14952|NCT03371199|"~     The study investigates the association between normalization of serum sodium levels and bone~     markers in patients with epilepsy and chronic hyponatremia.~      The study is a randomized, single blinded, placebo controlled study where participants will~     be randomized to either treatment with salt tablets or placebo tablets through 4 months. At~     the beginning and end of the 4 months bone markers will be measured.~      The investigators null-hypothesis is that there will be no difference in bone markers before~     or after the intervention.~   "
14953|NCT03371186|"~     The investigators will conduct a cluster-controlled, stepped wedge implementation science~     trial of a bundled reproductive, maternal, neonatal, and child healthcare (RMNCH) delivery~     intervention within an approximate population of 300,000 people in rural Nepal. This~     intervention integrates five evidence-based approaches for reproductive, maternal, newborn,~     and child health focused on the golden 1000 days from conception through age two: 1)~     Community Health Worker model of home-based care to monitor and increase utilization of~     services, maternal and neonatal health knowledge, self-efficacy, social support, and~     emergency planning among mothers; 2) Continuous surveillance of all pregnancies and children~     via an integrated electronic medical record; 3) Delivering community-based integrated~     management of newborn and childhood illness (CB-IMNCI) via CHWs; 4) Group antenatal and~     postnatal care to improve care delivery and reduce mortality during the golden 1000 days~     from conception to age two; and 5) Balanced counseling to increase post-partum contraception.~   "
14954|NCT03371173|"~     This is an explorative, open-label, uncontrolled, single center study to explore the~     preliminary safety, tolerability and efficacy of oral ferric maltol in treating iron~     deficiency in patients with pulmonary hypertension and iron deficiency anemia.~   "
14955|NCT03371147|"~     The primary purpose of this study is to evaluate the use of a digital information and~     communication platform (DICP) in improving outcomes in patients with cancer and their~     caregivers.~   "
14956|NCT03371134|"~     Deficits in skeletal muscle function exist during aging and muscular dystrophy, and~     suboptimal function has been related to factors such as atrophy, excessive inflammation and~     fibrosis. Sarcopenia is the age-related loss of skeletal muscle mass and function. It is now~     recognised as a major clinical problem for older people and research in the area is expanding~     exponentially. This interest stems from the fact that sarcopenia is both common and~     associated with serious health consequences in terms of frailty, disability, morbidity and~     mortality. The age-related loss of human skeletal muscle mass is due to a decrease in~     myofibre size and number with the loss of both fast and slow type myofibres, although the~     loss of fast myofibres tends to start earlier, at ∼70 years. Many factors influence the~     decrease in muscle mass. A significant contributor is an anabolic resistance of older~     skeletal muscle to protein nutrition as seen during immobilisation which can be ameliorated~     at least in part by resistance exercise and dietary supplementation. Other intensive areas of~     research are related to the loss of innervation and oxidative damage. Moreover, ineffective~     muscle regeneration underlies each condition and has been attributed to a deficit in myogenic~     potential of resident stem cells or satellite cells. It is now widely accepted that satellite~     cells, and generally adult stem cells, are normally quiescent and tend to reside in hypoxic~     areas of the tissue to preserve their undifferentiated state. To govern these processes,~     cells have developed a very complex machinery that is mainly regulated by a group of~     transcription factors known as hypoxia-inducible factors (HIFs). In particular, several~     observations support the idea that oxygen deprivation and HIF-1a may play a key role during~     ischemia to activate the regeneration process, which, after an initial hypoxic insult, needs~     to proceed under normoxia. On these bases, in this study we will investigate the role of~     HIF-1a in skeletal atrophy during aging.~   "
14957|NCT03371121|"~     Aim of the study is to evaluate clinical and radiographic outcomes in patients undergone~     all-arthroscopic autologous matrix induced chondrogenesis for symptomatic osteochondral talar~     lesions~   "
14958|NCT03371108|"~     Primary Objective:~      • To demonstrate equivalence of Gan & Lee Insulin Glargine Injection and Lantus® in terms of~     immunogenicity~      Secondary Objective:~      • Immunogenicity: To evaluate the percentage of subjects with negative anti-insulin~     antibodies (AIA) at baseline who develop confirmed positive AIA up to Week 26~   "
14959|NCT03371095|"~     Behçet's disease (BD) is a systemic vasculitis of arterial and venous vessels of any size,~     involving young patients (from 15 to 45 years). BD significantly increases morbidity and~     mortality. Therapeutic management of BD depends on the clinical presentation and organ~     involved. Although colchicine, nonsteroidal antiinflammatory agents and topical treatments~     are often sufficient for mucocutaneous and joint involvement, more aggressive approach with~     immunosuppressive agents is warranted for severe manifestations. Early recognition and~     vigorous use of immunosuppressives with high dose steroids have changed the prognosis of~     patients with severe BD. BD is a severe systemic vasculitis leading to blindness in up to 20%~     at 4 years and a 5-year mortality rate of 15% in patients with major vessel or neurological~     involvement. Cyclophosphamide has been used for life-threatening BD for 40 years. However,~     the outcome of severe complications of BD is poor. The European League Against Rheumatism~     (EULAR) recommendation for the management of BD advocated cyclophosphamide plus~     glucocorticoids for life-threatening manifestations (i.e neurological and/or major vessel~     involvement). TNFa antagonists have been used with success in severe and/or resistant cases.~     In addition, the incidence of blindness in BD has been dramatically reduced in the recent~     years with the use of anti-TNF. However, there is no firm evidence or randomized controlled~     trials directly addressing the best induction immunosuppressive therapy in severe BD~     manifestations. The investigators therefore aimed to assess the best induction therapy in~     severe and difficult to treat BD patients. The investigators hypothesize that up to 70% of~     the patients with life-threatening manifestations of BD receiving these compounds [anti-TNFa~     or cyclophosphamide] will achieve a complete remission of BD at 6 months and with less than~     0.1 mg/kg/day of prednisone.~      ITAC, is the first randomized prospective, head to head study, comparing infliximab, to~     cyclophosphamide in severe manifestations of BD. There is no firm evidence or randomized~     controlled trials directly addressing the best induction immunosuppressive therapy in severe~     BD. Cyclophosphamide failed to demonstrate sustainable remission over 70 % of life~     threatening BD cases. There is little published information on use of immunosuppressants~     other than cyclophosphamide for severe BD. TNFa antagonists have been used with success in~     severe and/or resistant cases. TNFa expression correlates with BD activity and other~     immunological data provide a strong rationale for targeting BD with biologics. Despite a~     strong rationale, these compounds are not yet approved in BD, which guarantees the innovative~     nature of this study that aims selecting or dropping any arm when evidence of efficacy~     already exists.~   "
14960|NCT03371082|"~     Primary Objective:~        -  To demonstrate equivalence of Gan & Lee Insulin Glargine Injection and Lantus® in terms~          of immunogenicity~      Secondary Objective:~        -  Immunogenicity: To evaluate the percentage of subjects with negative anti-insulin~          antibodies (AIA) at baseline who develop confirmed positive AIA up to Week 26~   "
14961|NCT03371069|"~     The use of methylphenidate in children and adolescents in France from 2010 to 2015~   "
14962|NCT03371056|"~     The purpose of the protocol is to validate a novel point of care multiplex system to detect~     and characterize microorganisms responsible for neonatal sepsis, as well as biomarkers of~     infection, from a simple vaginal sample, in order to improve the prevention of perinatal~     bacterial infections.~   "
14963|NCT03371043|"~     outpatient use of analgesics in children and adolescents in France from 2012 to 2015~   "
14992|NCT03370666|"~     Randomized multicenter non-inferiority trial comparing High flow nasal therapy (HFNT) versus~     Noninvasive ventilation (NIV) in patients with chronic obstructive pulmonary disease (COPD)~     and acute hypercapnic respiratory failure.~   "
18019|NCT03331081|"~     The question is whether vesical training and TMAP can be used in isolation without treatment~     of overactive bladder syndrome? ALSO will be evaluated in urinary symptoms, a function of the~     MAP, a quality of life and a satisfaction of the women with the treatment offered.~   "
14964|NCT03371030|"~     The skin, the bones, and most muscles received branches from the source arteries of at least~     two angiosomes, thus revealing one of the important anastomotic pathways by which the~     circulation is reconstituted in those cases where a source artery is interrupted by disease~     or trauma.~      There are numerous metaphyseal-epiphyseal branches arise within the pronator quadratus and~     the anterior interosseous artery and course towards the distal radius. These branches may be~     fundamental to the healing of the distal radius fractures and make nonunion a rare~     complication. The aim of this study is the evaluation of the role of the pronator quadratus~     muscle and its repair in volar approach in distal radius fractures treated with plate~     fixation.~   "
14965|NCT03371017|"~     This study will evaluate the efficacy and safety of atezolizumab plus chemotherapy compared~     with placebo plus chemotherapy in patients with inoperable recurrent triple-negative breast~     cancer (TNBC).~   "
14966|NCT03371004|"~     4-Demethyl-4-cholesteryloxycarbonylpenclomedine (DM-CHOC-PEN) is a polychlorinated pyridyl~     cholesterol carbonate that is lipophilic, electrically neural, crosses the blood brain~     barrier (BBB), ability to localize in intracranial tumor tissue, lacks neurotoxicity and not~     transported out of the brain via Pgp (p-glycoprotein) (1). DM-CHOC-PEN has completed Phase~     I/II trials in humans with primary and secondary tumors involving the brain with success.~     Complete remissions in both primary astrocytoma and metastatic lung and leukemia~     malignancies.~      This trial is open for adult subjects with advanced cancer - brain involvement is required.~   "
14967|NCT03370991|"~     Postmenopausal women are at an increased risk of developing cardiovascular disease (CVD)~     largely due to accelerated aging-related modifications to vascular health following~     menopause. The vascular endothelium is responsible for producing chemicals that are essential~     for proper vasodilation and blood flow and therefore is involved in maintaining normal blood~     pressure. A major modification that occurs during aging and is accelerated during menopause~     is termed vascular endothelial dysfunction which is characterized by impaired~     endothelium-dependent dilation. This can lead to increased blood pressure, atherosclerosis,~     and increased risk of CVD and death. Nitric oxide (NO) is a chemical produced by the~     endothelium and is essential for normal endothelial function and cardiovascular health.~     Vascular endothelial dysfunction is primarily caused by reduced NO bioavailability secondary~     to excessive oxidative stress. Approximately 3/4 of postmenopausal women have elevated blood~     pressure or hypertension which further worsens endothelial function and increases CVD risk~     through increased oxidative stress and inflammation. Blueberries are rich in phytochemicals~     including anthocyanins, phenolic acids, and pterostilbene. These phytochemicals and their~     metabolites are known to attenuate oxidative stress and inflammation. The overall goal of the~     current study is to assess the efficacy of blueberries to improve vascular endothelial~     dysfunction in this high-risk population and to gain insight into underlying mechanisms. 58~     postmenopausal women with elevated blood pressure and stage 1-HTN and vascular endothelial~     dysfunction at the screening visit will be asked to consume 22 grams freeze-dried blueberry~     powder or placebo powder per day for 12 weeks. Vascular endothelial function will be assessed~     at baseline and 12 weeks. Measurements indicative of vascular nitric oxide production,~     oxidative stress, inflammation, cardiometabolic health, cognitive function, and blueberry~     phytochemical metabolism will be measured at baseline and 12 weeks. Blood pressure will be~     assessed at baseline and 4, 8, and 12 weeks.~   "
14968|NCT03370978|"~     Ensuring follow-up for patients after discharge from the emergency department (ED) has long~     been a concern for ED care providers. The current technology of text messaging may be able to~     assist us in improving follow-up rates. In addition, having a quick and easy communication~     tool to be in touch with providers may improve overall patient satisfaction. This study is~     designed to evaluate the usage of text messaging to improve follow-up appointment compliance~     from the Emergency Department. In this study, a prospective randomized controlled trial (RCT)~     will be performed (involving patients scheduled by Emergency Department Nurse Navigators to~     follow up with Family Medicine) in which patients will be randomized to a texting appointment~     reminder versus standard-of-care (no texting reminder) group. Texted patients will receive~     reminders 3 days and 1 day prior to their follow-up appointment. In addition, the patients~     will have the ability to text back-and-forth with the Nurse Navigators in order to ask~     questions/request clarification if needed. Chart review will be performed of both groups to~     evaluate the number of follow-up appointments that patients attended versus rescheduled~     versus did not attend/reschedule. These values will then be compared to the retrospective~     chart review previously performed to evaluate for non-inferiority of text messaging as a~     means of improving patient attendance at follow-up appointments.~   "
14969|NCT03370965|"~     Background: Optic neuritis is a frequent cause of vision loss encountered by ophthalmologists~     in the Caribbean. The diagnosis is made on clinical grounds. Optic neuritis can occur either~     in an isolated manner or, most often, as the first symptom of multiple sclerosis (MS) or~     neuromyelitisoptica (NMO). These 2 demyelinating disorders differ by many means, including~     treatment and prognosis. MS can cause severe long-term disability while NMO is a short-term~     sight- and life-threatening condition causing potential relapses, which may require plasma~     exchanges. Furthermore, disease-modifying therapies used in NMO are different from those used~     in MS, which can worsen the natural history of NMO. Early differential diagnosis of these~     diseases is thus crucial for preventing severe visual loss and disability.~   "
14970|NCT03370952|"~     Under general anaesthesia, the patient is placed in the modified dorsal lithotomy position a~     10-mm umbilical trocar is inserted. A panoramic view of the pelvis was obtained together with~     full assessment of the ovarian mass(es).~      Aspiration of the cyst:~      Veress needle is inserted in the midline 2 cm above the symphysis pubis to aspirate the cyst~     under laparoscopic guidance (to guide the entry of the needle into the cyst wall & to confirm~     complete aspiration).~      Delivery of affected ovary outside the abdominal cavity:~      Classic ovarian cystectomy will be done using microsurgical techniques in which the cyst wall~     will be dissected gently and carefully from the healthy ovarian tissue followed by perfect~     haemostasis and re-fashioning of the remaining ovarian tissue using Vicryl (3-0) sutures.~      Re-introduction of the ovary to inside the abdominal cavity:~      The stitched ovary is pushed gently inside the abdominal cavity and the mini-laparotomy is~     re-covered by the rubber shield (to allow re-inflation of the abdominal cavity). The ovary is~     reassessed under laparoscopic guidance to ensure perfect haemostasis and normal position of~     the ovary. Pelvic irrigation is done if needed.~   "
14971|NCT03370939|"~     Endovascular treatment has been proven to be effective and safe for patients with acute~     ischemic stroke caused by large artery occlusion. It has become the first-line therapy in~     such patients. It is known that time from symptom onset to artery recanalization was a major~     factor that affects the efficacy of the endovascular therapy. However, optimal workflow of~     the treatment was still unclear which restrains the effect of the treatment in real world.~      The aim of this study was to determine the key element that causes the treatment delay by~     registering the major time points in the workflow and to develop an optimal workflow for the~     endovascular treatment in patients with acute ischemic stroke.~   "
14972|NCT03370926|"~     Glioblastoma is the most common malignant brain tumor in adults. The primary treatment~     consists of maximal tumor removal followed by radiotherapy (RT) with concomitant and adjuvant~     temozolomide. Tumor recurrence after chemoradiotherapy has previously been shown to be~     predominantly within or at the margin of the irradiated volume, but distant failure are not~     rare, especially in patients with MGMT methylation.Traditionally, RT has been planned based~     on on planning CT with co-registered postoperative MRI, with the addition of a clinical~     target volume margin of 2-3 cm to account for infiltrative odema.~      To better characterize the disease, more specific physiological and/or metabolical markers of~     tumor cells, vascularization and hypoxia measured on multiparametric MRI as perfusion,~     diffusion and spectroscopy alongside with PET tracer like Fluoroéthyl-L-tyrosine ([18F]-FET)~     are now available and suggest that aggressive areas, like uptake of PET tracer and~     vascularity are present outside areas of contrast enhancement usually irradiated. These~     informations could be incorporated to optimize the treatment of radiotherapy.~   "
14973|NCT03370913|"~     This clinical trial is being conducted to learn more about a potential treatment~     (valoctocogene roxaparvovec) for people with severe hemophilia A. This research study will~     test and confirm the safety and effectiveness of the 6E13 vg/kg dose of the study drug~     (valoctocogene roxaparvovec) that contains the correct gene to make Factor VIII so that the~     body can make its own Factor VIII that functions properly. Only one dose of valoctocogene~     roxaparvovec is being given in this study, and this dose has been previously studied in~     another clinical trial in patients with hemophilia A. This is a phase 3 study which is meant~     to show that the study drug is safe and works to help treat hemophilia A. The study will see~     if liver cells are able to make Factor VIII that functions properly after receiving this~     study drug. The study will also examine the effects that the study drug has on how much~     Factor VIII concentrates patients have to inject into their veins and on their bleeding~     episodes after the study drug has been administered. Finally, the study will see if and how~     the body responds to the study drug - for example, whether liver cells become inflamed or~     whether the body makes antibodies (something the immune system makes to protect itself~     against things like bacteria and viruses) against the vector or the new Factor VIII gene.~   "
14974|NCT03370900|"~     Learning retention after the deliberate practice of radiograph interpretation may be~     challenging for image types which are common enough to be clinically relevant but not so~     common that proficiency can be sustained through clinical practice. This is especially~     relevant for radiographs such as paediatric elbow films (EXR) that carry high risks for the~     patient if pathology is missed. Building on prior research in this area, this study will~     develop an innovative computer learning application for paediatric EXR interpretation. After~     an initial learning period, this study will quantitatively determine the rate of skill decay~     and the optimal timing for refresher-education.~   "
14975|NCT03370887|"~     This is a randomized, double-blind, placebo-controlled, sequential design, multicentre study~     in patients with moderately impaired systolic function undergoing CABG surgery. Twenty four~     (24) patients scheduled for elective bypass surgery will be randomized (up to approximately~     33 patients if replacements are needed). The objective is to investigate safety and~     tolerability of AZD8601 following epicardial injection in patients undergoing Coronary Artery~     Bypass Grafting (CABG) surgery with moderately impaired systolic function. At Visit 3~     patients will receive either AZD8601 or placebo as epicardial injections and will then be~     followed up at 14 days (telephone visit) and 1, 3 and 6 months (on-site) post-surgery.~   "
14976|NCT03370874|"~     This is a phase III double-blind study to evaluate the efficacy and safety of ALLO-ASC-DFU in~     patients with Diabetic Foot Ulcer, compared to placebo therapy.~   "
14977|NCT03370861|"~     The purpose of this research study is to examine the relationship between the microbiota~     (microscopic organisms) in the gut and the activity of the immune system during melanoma~     immunotherapy.~   "
14978|NCT03370848|"~     The purpose of this study is to determine whether psyllium is effective in reducing flushing~     due to niacin and also to measure the effect of niacin on cholesterol levels.~   "
14979|NCT03370835|"~     Use of beta-blockers has proven beneficial in patients with hypertension, heart failure, and~     in people who have suffered a heart attack. The use in patients who have Chronic Obstructive~     Pulmonary Disease (COPD) and reactive airway disease, however, has been limited due to~     possible side effects such as worsening of lung function or increasing airway spasms and~     asthma attacks. The purpose of this study is to find out if patients with COPD can tolerate~     being on a beta-blocker at doses recommended for the treatment of heart disease conditions.~     This study also seeks to find out if a selective beta-1 receptor beta-blocker is better than~     a non-selective beta-blocker in patients with mild to moderate COPD.~   "
14980|NCT03370822|"~     A stillbirth describes when a baby dies after 24 weeks of pregnancy and before being born. In~     the UK there are roughly 9 stillbirths every day. Normally, before a stillbirth occurs~     changes such as a slower heart rate and reduced movement take place. Fetal monitoring~     attempts to detect these changes so that babies can be delivered before they become severely~     ill. If a baby could be monitored continuously then these changes could be detected earlier.~     However, current forms of fetal monitoring, such as ultrasound, cannot be used for long~     periods of time and do not significantly reduce stillbirth rates. The Monica AN24 device is a~     continuous monitor which records the baby's heart rhythm using sensors placed on the mother's~     abdomen. As this is a new device there is little evidence about how well it works. In this~     project women will be asked how they feel about the device after wearing it. Doctors and~     midwives will also be asked about their views of the device. The effect of the mother's~     movement and the age of the baby on how well the Monica AN24 can record the baby's heart~     rhythm will also be assessed.~   "
15034|NCT03370120|"~     The purpose of the study is to evaluate the long-term safety and tolerability of Padsevonil~     administered at individualized doses as adjunctive treatment for subjects with drug-resistant~     epilepsy.~   "
15125|NCT03368924|"~     Despite important advances in the current understanding of sickle cell vaso-occlusion, the~     basis of its control and prevention remain partially unknown. The primary purpose is to test~     the hypothesis of a control of the sickle cell vaso-cocclusive (VOC) process by the anti band~     3 antibodies by assessing the level of these antibodies in the steady state and during the~     crises in SCA patients. To assess the relationship between the level of band 3 antibodies,~     the oxidation status, the expression of microparticles and the hemorheological alterations of~     the sickle red cells (SS RBs), the severity of VOC.~   "
14981|NCT03370809|"~     Oncogeriatric frailty assessment is a multifactorial approach to determine the most~     appropriate treatment for the health status of elderly cancer patients and this assessment is~     recommended for patients over 75 years of age.~      Oncogeriatric frailty is based on the SIOG-2 clinical scale (assessing comorbidities,~     autonomy, nutrition, cognitive and thymic domains) defining 3 levels of frailty: (1)~     harmonious aging, (2) vulnerability (reversible stage), (3) fragility (irreversible stage).~      So,the management of very old or very frailty patients with poor tolerance or compliance to~     treatment, often requires to defer standard treatment and monitoring procedures. That is~     detrimental to these patients prognosis. By contrast with elderly or very old patients~     without frailty criteria, could benefit from more efficient procedures.~      More generally, frailty is associated directly with a cerebral impact on a cogntif or thymic~     status or indirectly with the cognitive or thymic impacts related with other components~     (nutritional or autonomy or walking poor status, comorbidities) 18F-Flurodeoxyglucose~     (18F-FDG) Positron Emission Tomography (PET), is routinely performed in follow-up cancer~     patients in most cases, including older patients, to detect neoplastic localizations on the~     whole body. It also accurately quantifies cerebral glycolytic metabolism when early brain~     recording is performed. Brain metabolism reflects the neuronal synaptic activity. It is~     generally decreased in particular brain areas due of neurodegenerative damage with a little~     or no symptom, of thymic involvement particular in depression or during accelerated cerebral~     aging of vascular origin. The impairment of the brain function of the elderly, as evidenced~     by 18F-FDG PET, is most often multifactorial, as frailty. Above all, brain changes are~     visualized with 18F-FDG PET much earlier than using neuropsychological tests, especially for~     cognitive impairment.~      Our hypothesis is that with 18F-FDG PET, performed routinely in the initial assessment in~     elderly patients with cancer, it is also possible to obtain reliable and objective parameters~     of brain function and frailty. 18F-FDG PET is already used to identify cognitive and thymic~     impairment. This exam would help to assess the frailty and to adapt as best oncologic~     treatments some of which can also be neurotoxic. 18F-FDG PET is therefore related to brain~     function in frail patients~   "
14982|NCT03370796|"~     The project presented here respond to this emerging need by implementing a Reminiscence~     Therapy program dedicated to elderly people in an institutional context. This will be a~     multicenter, randomized controlled study in which the participants' allocation will be made~     without their knowledge. Before the randomization process, the screening evaluation will be~     done, which will allow to verify the presence of the inclusion and exclusion criteria. The~     target population will be people age 65 or above years who present cognitive decline. After~     the randomization process, participants will be allocated randomly in the experimental group~     where the reminiscence program (composed by a main strand and maintenance strand) or in the~     usual institutional care group. The evaluation of the participants will be carried out~     individually and will take place in four different moments.This study will be conducted in~     RSE in the central region of Portugal.~   "
14983|NCT03370783|"~     This study examines the effects of moderate alcohol intake on the brain, the immune system,~     and cognition.~   "
14984|NCT03370770|"~     This is a non-interventional, multi-country, multi-centre cohort study based on existing data~     from medical records of patients with EGFR mutation-positive advanced NSCLC treated with~     afatinib (Gi(l)otrif®) as the first-line treatment followed by osimertinib in case the T790M~     resistance mutation was developed.~   "
14985|NCT03370757|"~     The purpose of this study is to explore the impact of bundling nursing care activities on the~     overall health of Very Low Birthweight (VLBW) preterm infants who receive bundled care in a~     Level IV Neonatal Intensive Care Unit (NICU). The study will evaluate differences in infant~     health when diaper changes occur at 3- versus 6-hours during 3-hour bundled care. Differences~     in infant skin health between 3- and 6-hour bundled care diapering at two sites (buttocks and~     chest) will also be evaluated.~   "
14986|NCT03370744|"~     To establish models of normal and pathological cognitive aging.To collect the longitudinal~     data of SCD population, to study the dynamic changes of brain networks so as to explore the~     progressive mechanisms of AD on brain networks and to construct a high-precision multi-modal~     model for early diagnosis.~   "
14987|NCT03370731|"~     Obstructive sleep apnea (OSA) is a disease characterized by repeated partial or complete~     upper airway collapse during sleep, accompanied by arousals or oxygen desaturation. It was~     reported to affect 5.7 %~9.6 % of pediatric population in western countries and 5.5 %~7.8 %~     in China. Children's physical developing and brain functioning as well as quality of life~     (QoL) could be greatly impaired if the disease was left untreated.~      Polysomnography (PSG) was recognized as gold standard for diagnosing OSA. However, for~     pediatric OSA, there exists dispute on the PSG diagnostic criteria.~      Pediatric OSA was mostly caused by hypertrophy of adenoid or palatine tonsillar. For those~     PSG validated patients, nonsurgical management was often prescribed, in addition, surgical~     intervention, i.e. adenotonsillectomy was also commonly applied and had been proved efficient~     both in terms of PSG and in terms of symptoms, behaviors and QoL rated by caregivers.~     However, for children with controversial diagnoses by ATS and ICSD-3, little was known about~     whether surgical or nonsurgical management was effective.~      We aim at investigating the effect of adenotonsillectomy versus nonsurgical management on QoL~     in these subjects. And the hypothesis is that adenotonsillectomy improves QoL better than~     nonsurgical management in children with controversial diagnoses of OSA by ATS and ICSD-3.~   "
14988|NCT03370718|"~     The goal of this clinical research study is to learn if cabozantinib can help to control~     unresectable (cannot be removed with surgery) or metastatic (has spread) adrenocortical~     carcinomas. The safety of this drug will also be studied.~      This is an investigational study. Cabozantinib is FDA approved and commercially available to~     treat medullary thyroid cancer and kidney cancer. It is considered investigational to use~     cabozantinib to treat adrenocortical carcinomas.~      The study doctor can explain how cabozantinib is designed to work.~      Up to 18 participants will be enrolled in this study. All will take part at MD Anderson.~   "
14989|NCT03370705|"~     A randomized Multicentric open-label controlled trial. The primary objective of the study is~     to assess the improvement of endothelial function under sulodexide + conventional treatment~     or conventional treatment alone in patients with Leriche-Fontaine stage II peripheral~     arterial obstructive disease (systolic ankle brachial index ABI < 0. 9).~   "
14990|NCT03370692|"~     The two main aims of the study:~        1. To investigate the relation of Frailty, Activity of daily life (ADL), Cognitive~          functions and Co-morbidity on survival at 30 days (and 6 months in a substudy)~        2. From the results design a prognostic score that will be validated using a subpopulation~          of the study cohort~      Two secondary aims a~        1. Survival at 6 months (in a subpopulation of the study)~        2. An inter-rater validation of the Clinical Frailty Score (CFS) (in a subpopulation)~   "
14991|NCT03370679|"~     With this project the investigators aim to investigate whether premature ventricular~     complexes (PVC) have a prognostic significance in persons without structural heart disease.~     Further the investigators look at the possible connection between PVC-morphology and clinical~     outcome and investigate whether advanced cardiac imaging-methods may identify subtle signs of~     heart disease in PVC-patients with normal findings at echocardiography.~   "
14993|NCT03370653|"~     Mucopolysaccharidoses (MPS) are a group of rare inherited disorders characterized by a~     deficiency of lysosomal enzymes responsible for the normal degradation of glycosaminoglycans~     (GAGs). Medical need for treatment of MPS is still very high due to the poor penetration of~     the recombinant enzymes into the blood brain barrier as well as the ocular barriers and into~     tissues that are poorly vascularized, such as cartilages and bones. Odiparcil is an orally~     active compound that allows the synthesis of soluble glycosaminoglycans (GAGs), mainly~     chondroitin sulfate (CS) and dermatane sulfate (DS). The neosynthesized solubles GAGs are~     then excreted in urine. By diverting endogenous GAG synthesis to the synthesis of soluble~     odiparcil linked GAGs, odiparcil should decrease the intracellular pool of GAGs and~     consequently decrease the lysosomal GAG accumulation.~      The primary objective of the study is to assess the safety and efficacy of two doses of~     odiparcil in MPS VI patients and to provide evidence to enable the selection of the relevant~     dose of odiparcil for phase III study. The secondary objective of this study is to~     characterize the dose response, PK and PD of odiparcil.~   "
14994|NCT03370640|"~     This is a multiple oral dose, open-label study to assess the safety, tolerability, and~     pharmacokinetics of SEP-363856 in Japanese subjects with schizophrenia.~   "
14995|NCT03370627|"~     The pathogenic role of type I interferons (IFNs) in the development of different autoimmune~     diseases has been extensively described in the literature. Since plasmacytoid dendritic cells~     (pDCs) are the main source of type I IFNs, there is evidence of the involvement of pDCs in~     autoimmune diseases. The CD303 surface protein (also called BDCA-2) is specifically expressed~     by the pDCs.~      The hypothesis leading to the realization of this study is to observe, in vitro, an~     inhibition of the secretion of the type I IFNs by pDCs in the peripheral blood in patients~     with autoimmune disease, thanks to the action of the anti-CD303 antibody Developed by the LFB~     Group, which could reduce the inflammatory response and improve patients with autoimmune~     disease~   "
14996|NCT03370614|"~     Although underutilized, what is emerging as one of the best ways of evaluating inflammation~     in the body, particularly in difficult to observe regions, is through the use of~     Fluorodeoxyglucose (FDG) positron emission tomography (PET). FDG is taken up in the body much~     like glucose and is particularly taken up in areas of inflammation where there is increased~     metabolism. Therefore, this technology can be used to assess inflammation, and measure the~     reduction in inflammation as the result of integrative interventions that target dietary~     modifications designed to reduce inflammation. With this proposed study, we plan to use FDG~     PET-MRI technology to develop a more specific and sensitive approach for evaluating areas of~     inflammation associated with IBS and measuring improvements in that inflammation in response~     to effective integrative interventions.~   "
14997|NCT03370601|"~     This study evaluates 2 therapeutic strategies (increase infliximab dose or add an~     immunosuppressant) in patients with inflammatory bowel disease in loss of response to~     infliximab. Addition of an immunosuppressant may be more efficient at long term and is less~     expensive.~   "
14998|NCT03370588|"~     Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) has been~     reported to be an effective treatment approach for peritoneal cancer, however, the stress~     response to HIPEC is major neuroendocrine and cytokine response, which has been considered as~     the homeostatic defense mechanism. Recently, dexmedetomidine has been suggested to exhibit~     anti-inflammatory properties. This study was designed to evaluate the effect of perioperative~     administration of dexmedetomidine on inflammation response and postoperative outcomes in~     patients undergoing hyperthermic intraperitoneal chemotherapy (HIPEC) cytoreductive surgery.~   "
14999|NCT03370575|"~     This study evaluates the difference of imaging diagnostic quality and fertility promoting~     effect in the diagnosis and treatment of infertility by hysterosalpingography between using~     ethiodized poppyseed oil and the second-generation non-ionic monomer contrast. Half of~     participants will receive ethiodized poppyseed oil for hysterosalpingography, while the other~     half will receive the second-generation non-ionic monomer contrast for hysterosalpingography.~   "
15000|NCT03370562|"~     This is a randomized double blinded trial to determine if a small dose of dexmedetomidine can~     prevent and relieve nausea and shivering, two of the more common complaints after cesarean~     delivery.~   "
15001|NCT03370549|"~     Our objective for this R34 is to develop gender/culture specific and trauma informed group~     psychotherapy intervention designed to treat Chinese-, Korean-, and Vietnamese-American young~     women with histories of interpersonal violence trauma. The intervention is called Asian~     Women's Action for Resilience and Empowerment (AWARE).~   "
15002|NCT03370536|"~     This is a prospective, multi-center, non-randomized, un-blinded, observational trial.~   "
15003|NCT03370523|"~     As the proportion of elderly population increasing over the last years, polypharmacy and~     drug-drug interactions (DDI) has been a common health care problem. This study will be~     performed to find out to prevalence of polypharmacy, inappropriate drug use and DDIs in in~     elderly patients presenting to a outpatient cardiology clinics.~   "
15004|NCT03370510|"~     The present study examines the impact of oxytocin (OXT) and Pivotal Response Treatment (PRT)~     on the development of language, social, and play skills in young children with Autism~     Spectrum Disorder (ASD). The purpose of this study is to examine the impact of OXT as an~     enhancer of response to PRT. Participants will be randomly assigned to either an intranasal~     OXT group or a placebo group. Neither the research team nor the participants will know or~     choose which group the participant is assigned to. Children in both groups will participate~     in a 16-week trial of PRT. The trial will test the hypothesis that children with lower levels~     of activity in and functional connectivity among certain PRT-response brain regions will~     benefit more from the administration of OXT vs. placebo as an enhancer to a 16-week trial of~     PRT.~   "
15005|NCT03370497|"~     Gut hormones have therapeutic potential in the prevention and treatment obesity and type 2~     diabetes (T2D). Rodent evidence suggests that calcium may potentiate the effects of protein~     ingestion on gut hormone secretion. Evidence in humans however, is lacking. This study aims~     to assess whether the addition of calcium to protein ingestion augments postprandial gut~     hormone availability in humans.~   "
15006|NCT03370484|"~     Gut hormones have therapeutic potential in the prevention and treatment obesity and type 2~     diabetes (T2D). Rodent evidence suggests that calcium may stimulate gut hormone secretion.~     Evidence in humans however, is lacking. This study aims to assess whether the calcium~     ingestion stimulates gut hormone availability in humans.~   "
15007|NCT03370471|"~     The aging Veteran population will substantially increase over the next 10 years, as the 24.9%~     of Veterans who are currently between 55-64 years of age join the 38.5% who are already over~     age 65. The risk of stroke more than doubles each decade after age 55, which places Veterans~     at an ever-increasing risk of suffering stroke-related language impairment (i.e., aphasia).~     Difficulty retrieving words, which negatively impacts psychosocial well-being and quality of~     life, is the most common complaint in healthy aging and aphasia. Word retrieval interventions~     to maintain or restore communicative function are needed. Studies have shown that physical~     exercise can improve word learning in young adults. This study will investigate the effects~     of exercise on word learning in aging and aphasia. The results will help the us understand~     how exercise may be used to optimize word retrieval interventions for our aging Veterans.~   "
15008|NCT03370458|"~     This project aims to study the benefits of probiotics namely Lactobacillus plantarum DR7 for~     brain health properties, primarily alleviation of stress, among adults in Malaysia aged from~     18 to 60 years.~   "
15009|NCT03370445|"~     The aim of the proposed study is to assess the efficacy of a low-literacy/numeracy-oriented~     intervention to promote healthy lifestyles and preventing obesity among young children in~     under-resourced communities. The study will occur in pediatric resident physician care~     practices since nationally, resident practice sites provide care to more than one-fifth of~     the socioeconomically disadvantaged families in the US.~   "
15010|NCT03370432|"~     The aim of this study is to investigate the interaction between intake of vitamin D and~     polymorphisms in GC and CYP2R1 in relation to risk of colorectal cancer in a Danish~     prospective cohort study.~   "
15011|NCT03370419|"~     Metabolic syndrome (MetS) is a leading risk factor for chronic disease among African~     American/Black populations. Fostering habit development offers a promising new approach to~     improving the effectiveness of lifestyle programs for people with MetS, yet this approach~     remains understudied. The long-term goal of this line of research is to test and disseminate~     an affordable and effective intervention for reducing MetS. The objective of the proposed~     project is to evaluate the feasibility of a novel, occupational therapist-delivered~     habit-development intervention targeting dietary and physical activity habits in up to 80~     African American/Blacks with MetS ages 40+ recruited from an emergency department in Detroit,~     MI. The specific aims are to (a) evaluate intervention feasibility and acceptability and (b)~     estimate intervention effect sizes for primary outcome measures of habit development and~     weight loss and secondary outcomes of blood pressure, BMI, and waist circumference. Through~     the 8-week intervention, indicators of intervention feasibility (e.g., time, effort, costs,~     participant recruitment and retention, satisfaction) will be tracked. Measures of habit~     development will be taken biweekly over the 8-week active intervention period and~     anthropometry measures will be collected at baseline and week 20.~   "
15012|NCT03370406|"~     This clinical trial proposes to evaluate a relatively unexplored approach to treatment of~     squamous cell carcinoma (SCC) on the lower extremities. The strategy is to directly and~     specifically deliver drug to the tumor. For the proposed phase I clinical trial, the~     investigators will perform intralesional injections of a well characterized, potent~     chemotherapeutic agent 5-fluorouracil (5FU) with and without a concomitant topical~     application of 5% imiquimod to kill topically accessible SCC cells. The goal of the study is~     to evaluate the safety profile and tolerability of intralesional-5FU with and without a~     concomitant topical imiquimod and measure the clinical objective response rate (ORR) in~     treated lesions compared to untreated lesions 3 weeks after treatment.~   "
15013|NCT03370393|"~     Adolescence is a time of biological and behavioral changes that can lead to risky and~     dangerous behaviors, and African-American youth are highly vulnerable to the consequences of~     risky behavior, including HIV/AIDS and violence, leading to premature death. The~     investigators previously showed that an intervention program reduces HIV-risk vulnerability~     behaviors in many African-American youth. The investigators aim to measure how the program~     affects different regions of the brain in order to better prevent or reduce such risky~     behaviors among African-American youth.~   "
15014|NCT03370380|"~     Uncontrolled single site non randomized non interventional study to determine the safety and~     efficacy of intravitreal injections of Aflibercept in patients with recent vision loss due to~     retinal pigment epithelial detachment secondary to AMD~   "
15015|NCT03370367|"~     In this trial the investigators propose to utilize 13-cRA to prevent dysplastic changes and~     second malignancies in patients with squamous cell carcinoma of the head and neck regions who~     have a high probability of cure from their primary cancer. Comparisons between patients~     treated by 13-cRA and patients receiving placebo will include:~        1. The time to diagnosis of second primary for the treatment versus control groups.~        2. Survival time for the treatment versus control groups.~        3. Secondarily, the cost-benefit ratio for 13-cRA will be analyzed by assessing the~          toxicities of 13-cis retinoic acid treated patients in comparison to those experienced~          by placebo treated patients.~   "
15016|NCT03370354|"~     This study is to determine the impact of night shift nurse's activity on patients' sleeping~     patterns in medical services including individual, clinical and environmental factors. The~     patients will be questioned in order to create both a control group and a group with troubled~     sleeping patterns.~   "
15017|NCT03370341|"~     This study investigates whether Introspective Accuracy (IA) can be improved in individuals~     with schizophrenia by stimulating the brain via transcranial Direct Current Stimulation~     (tDCS).~   "
15018|NCT03370328|"~     The purpose of this study is to determine if aromatherapy (essential oil) is effective at~     reducing up-set stomach and vomiting after surgery and in reducing the need for up-set~     stomach medications~   "
15087|NCT03369431|"~     The purpose of this study is to assess the effects of 3 months supplementation with the multi~     strain probiotic Vivomixx on the overall function, aberrant behaviours and frequency of~     gastrointestinal symptoms in children with Autism Spectrum Disorders and co-morbid~     gastrointestinal symptoms.~      The investigators will also assess the effect of the intervention on parenting stress.~      A further issue will be to identify any predictors of response to the probiotic.~      Finally, the investigators will assess whether there is an association between altered~     behaviour and altered gut function in users of Vivomixx.~   "
15126|NCT03368911|"~     The purpose of this study is an evaluation of the effect of the reinforced endotracheal tube~     on post-operative hoarseness and sore throat undergoing thyroidectomy~   "
15019|NCT03370315|"~     Parkinson's disease (PD), characterized as progressive and neurodegenerative, is one of the~     most frequent neurological diseases of the present time. Patients with PD present motor~     impairment, such as muscle stiffness, rest tremor, slow movements, postural instability, and~     gait and balance alterations; And non-motor factors, such as cognitive and neuropsychiatric~     disorders, depressive symptoms, and a consequent decrease in quality of life (QL). Dance can~     be an important tool for the complementary treatment of these patients, when added to~     traditional drug therapies and physiotherapies. Thus, the present study aims to verify the~     effects of a program of dance and walking in gait and QL of 38 adults with PD, divided in two~     groups, and to compare the aspects of functionality, dynamic stability, kinematics and QL.~     The data collection instruments will be a personal data sheet of the patients, the Hoehn and~     Yahr Scale (H&Y), the Rehabilitation Index (RI), the motor part of the Unified PD Rating~     Scale (UPDRS III), the Timed Up ang Go test (TUG), the kinematic analysis of walking and the~     Parkinson's Disease Questionnaire (PDQ-39). Statistical Package for Social Sciences (SPSS)~     software version 20.0 will be used to analyze the data, using the Wilcoxon test for~     non-parametric data and the paired t-test for parametric data, in order to compare pre and~     post intervention data. The significance level adopted for both tests will be p <0.05. It is~     expected that a program of 24 sessions of dance classes will be as or more effective than a~     program of 24 walking sessions for the gait quality and QL for the participants of the study.~   "
15020|NCT03370302|"~     The purpose of this study is to evaluate the safety and tolerability, recommended phase 2~     dose (RP2D), and to characterize PK of TAK-228 administered once daily or once weekly to East~     Asian participants with advanced nonhematological malignancies.~   "
15021|NCT03370289|"~     The purpose of this study is to evaluate the immunogenicity and safety of two intramuscular~     vaccinations with BLB-750 in healthy Japanese adults.~   "
15022|NCT03370276|"~     The purpose of this study is to find out if the combination of two established anti-cancer~     therapies are beneficial in participants with Head and Neck Squamous Cell Carcinoma (HNSCC).~     Specifically, investigators want to determine if the combination of Cetuximab and nivolumab~     can help people with advanced cases of HNSCC. Both cetuximab and nivolumab have been used~     separately to treat HNSCC and are Food and Drug Administration (FDA) approved in this type of~     cancer.~   "
15023|NCT03370263|"~     The objective of this study is to collect and assess the information about long-term safety~     and effectiveness of Benlysta for intravenous injection and Benlysta for subcutaneous~     injection (hereinafter referred to as Benlysta) in daily clinical practice. The aim of~     conducting this drug use investigation (DUI) in all subjects until data are accumulated from~     a certain number of subjects after Benlysta being marketed, data will be collected on safety~     and effectiveness of Benlysta in an early stage and thereby to take the necessary measures~     for proper use of Benlysta. Approximately 600 subjects will be enrolled in to this study. The~     observation period per subject will be 52 weeks from the start of Benlysta administration.~     BENLYSTA is the registered trademark of GlaxoSmithKline (GSK) group of companies.~   "
15024|NCT03370250|"~     Luminal subtype breast cancer, accounting for 70 to 80% of all breast cancers, has been~     reported to be associated with good prognosis. However, for the patients with large mass or~     worse mass position, free greater omentum transplantation may provide a new option for breast~     reconstruction.~   "
15025|NCT03370237|"~     The main objective of this research study is to validate the St Joseph's Health Care~     Harmonized Foot Ulcer Assessment and Stratification tool using inter-rater reliability~     technique to determine if the score would consistently be reproducible by examiners of~     different role (Nurse Practitioner, Family physician, Registered Nurse and Resident). A~     validated assessment tool allows collecting better quality data with high comparability which~     enhances quality of foot care and increases the credibility of the tool.~   "
15026|NCT03370224|"~     This study is a double-blind placebo-controlled randomized clinical trial (RCT) to provide~     Class I evidence in support of or in refute of the efficacy of the modified Story Memory~     Technique (mSMT) in healthy aging (HA)and in persons with mild cognitive impairment (MCI).~     Outcomes will be measured through three mechanisms: (1) a traditional neuropsychological~     evaluation (NPE) (2) an assessment of global functioning (AGF) examining the impact of the~     treatment on daily activities, and (3) an optional functional magnetic resonance imaging~     (fMRI) scan.~   "
15027|NCT03370211|"~     In this manuscript, we investigated the effect of resistance training (RT) on body~     composition, functional capacity, inflammatory and oxidative stress biomarkers in sarcopenic~     obesity elderly women, using a randomized controlled trial.~   "
15028|NCT03370198|"~     The purpose of this study is to test an experimental anti-cancer immunotherapy called NKR-2~     (modified T cells), to treat colorectal cancer with unresectable liver metastases. The trial~     will test three dose levels (dose escalation). At each dose, the patients will receive three~     successive hepatic transarterial administrations, two weeks apart, of NKR-2 cells. The study~     will enroll up to 18 patients.~   "
15029|NCT03370185|"~     This is a multi-center, single-arm, open-label, Phase 2 study of duvelisib, an orally~     bioavailable dual inhibitor of PI3K-δ,γ, in patients with CLL/SLL who have previously been~     treated with ibrutinib or another Bruton's Tyrosine Kinase Inhibitor (BTKi) and relapsed or~     were refractory to such therapy or discontinued such therapy due to toxicity.~   "
15030|NCT03370172|"~     The purpose of this study is to evaluate the safety and determine the dose of BAX 888~   "
15031|NCT03370159|"~     This phase I/II trial studies the side effects and best dose of 6,8-bis(benzylthio)octanoic~     acid (CPI-613) when given together with docetaxel and to see how well they work in treating~     patients with stage IIIB or IV non-small cell lung cancer. Drugs used in chemotherapy, such~     as CPI-613 and docetaxel, work in different ways to stop the growth of tumor cells, either by~     killing the cells, by stopping them from dividing, or by stopping them from spreading.~   "
15032|NCT03370146|"~     Motor imagery is increasingly used as a plasticity-booster to complement conventional~     rehabilitation. Here the investigators test the hypothesis that the combination of mental~     training with conventional rehabilitation may speed up the recovery in patients with total~     knee arthroplasty. The investigators also characterize the brain correlates of such recovery~     with imagery tasks for virtual reality environments.~   "
15033|NCT03370133|"~     This is a study to compare the efficacy of bimekizumab versus placebo and an active~     comparator in the treatment of subjects with moderate to severe chronic plaque psoriasis~     (PSO).~   "
15035|NCT03370107|"~     rTMS of the motor cortex is an increasingly established analgesic technique for the treatment~     of neuropathic pain. However its efficacy is generally modest. One reason may be the that~     conventional rTMS targets only superficial and small cortical regions of the human brain. A~     newer cooled coil, the Hesed (H) coils, now allows deep and larger surface of stimulation and~     has been suggested to have analgesic effects in a small pilot trial in diabetic painful~     polyneuropathy. Based on its deeper mechanism of action and larger surface of stimulation, we~     hypothesize that this technique will be more effective than rTMS in patients with central~     pain, a highly unmet medical need. The primary objective of the present study will be to~     compare the efficacy of H coil, conventional rTMS and sham stimulation of the primary motor~     cortex in patients central neuropathic pain. Major secondary objectives will be to directly~     compare the analgesic efficacy of H coil versus conventional rTMS, and compare the efficacy~     of both techniques in patients with lower limb pain and those with upper limb pain/face. This~     will be a randomized tricentric sham controlled study~   "
15036|NCT03370094|"~     Observational Study to investigate the technical feasibility, implementation into current~     diagnostic and treatment pathways and the diagnostic accuracy of the remote patient~     assessment by using mobile telecommunication ahead of hospitalization.~   "
15037|NCT03370081|"~     There is few information about the best capnometry value in recovery room for intubated~     awakening patients. Furthermore, capnometry values could influence ventilation applied by~     nurses on these patients. The aim of this study is to observe the effects of capnometry~     monitoring on intubated awakening patients in recovery room.~   "
15038|NCT03370068|"~     The use of Intracytoplasmic sperm injection (ICSI) has increased in the last decades~     regardless of the cause of infertility. Despite the increased use there is no clear evidence~     that ICIS is more effective than conventional in vitro fertilization (IVF) for non-male~     factor infertility. The investigators therefore aim to perform a prospective randomized~     controlled study to compare between ICSI and conventional IVF in women between 39 to 44 years~     of age with non-male factor infertility.~   "
15039|NCT03370055|"~     The trial compare the healing rate of chronic wounds with exposed tendon or bone~     ('problematic wound area') with LeucoPatch® treatment for 8 up to 16 weeks in addition to~     usual care versus usual care.~      The healing rate will be measured as relative reduction of 'problematic wound area' at 8~     weeks~   "
15040|NCT03370042|"~     Background and Objective: Gingival recession accounts for apical migration of the gingival~     margin resulting in exposure of the cementoenamel junction (CEJ) and root surface. It is a~     matter of concern for both patients and dental professionals, especially when exposure of the~     root surface is linked to deterioration in esthetic appearance and increase in dentinal~     hypersensitivity which leads to improvements in various surgical techniques that have been~     used to correct labial gingival recession defects. The present study thus was aimed to~     evaluate and compare the results of Semilunar Coronally Positioned Flap alone and Semilunar~     Coronally Positioned Flap in Conjunction with Free Gingival Graft for treatment of Miller~     Class I and II gingival recession defects in maxillary anterior teeth.~      Materials and Method: A total of 20 bilateral Miller's class I and II gingival recession~     sites in systemically healthy subjects, 20-45 years of age were recruited for this study.~     Recession sites were divided and randomly allocated to either of the two groups SCPF+FGG~     (test group) and SCPF (control group) with 10 sites per group to be treated with semilunar~     coronally positioned flap with free gingival graft technique for SCPF+FGG group and semilunar~     coronally positioned flap technique alone for SCPF group. Longitudinal alterations during a~     follow-up period of 1, 3, 6 and 12 months in terms of Probing depth (PD), Recession width~     (RW), Recession height (RH), Width of keratinized tissue (WKT) and Clinical attachment level~     (CAL) were measured for both the groups and the values were statistically analysed.~   "
15041|NCT03370029|"~     Primary ciliary dyskinesia is an autosomal recessive disorder characterized by abnormal~     ciliary movement and disrupted mucociliary clearance. In uncleaned airways, microorganisms~     and respiratory irritants cause inflammation and infection. Permanent rhinitis and chronic~     sputum cough are typical features in primary ciliary dyskinesia patients. Primary ciliary~     dyskinesia is a disease that threatens lung function from pre-school age. One of the main~     causes of respiratory muscle weakness in chronic lung diseases diseases is worsening of lung~     function. Such a weakness causes alveolar hypoventilation, microatelectasis, reduction of the~     cough strength .The cough strength is important for airway cleaning.~      Exercise capacity is affected in chronic lung diseases. Assessment of exercise capacity in~     chronic lung diseases is prognostically important. Reduced exercise capacity and pulmonary~     function in PCD cause decrease in physical activity level. PCD patients have low quality of~     life and early recognition has been found to affect the quality of life positively. Children~     with chronic illness have higher level of depression than healthy children.~      In literature, no study investigated respiratory muscle strength, exercise capacity and~     physical activity PCD patients. Therefore, the investigators aimed to compare aforementioned~     outcomes in PCD patients and healthy controls.~   "
15042|NCT03370016|"~     The purpose of this study is to evaluate clinical significance of low pressure~     pneumoperitoneum during robotically assisted radical prostatectomy (RARP).~   "
15043|NCT03370003|"~     To evaluate, in routine operational settings of treatment of uncomplicated Severe Acute~     Malnutrition (SAM) in children aged 6-59 months, the risk of nutritional recovery and~     hospitalization with non-routine use of amoxicillin compared to the risk achieved with~     systematic use of antibiotics.~   "
15044|NCT03369990|"~     This study is A Randomized, Double-blind, Placebo-controlled, Phase II Optimal Dose-finding~     Study to Determine the Safety and Efficacy of DWP450 in Subjects with Benign Masseteric~     Hypertrophy~   "
15045|NCT03369977|"~     A multi-center, randomized, controlled clinical trial is designed to investigate the safety~     and efficacy of BioGlue as an adjunct for structural repair and hemostasis to traditional~     surgical repair in Chinese subject with Acute type A aortic dissections.~   "
15046|NCT03369964|"~     This study will investigate the safety, pharmacology, and activity of atezolizumab in~     combination with immunotherapy agents with or without an anti-CD20 agent (i.e., obinutuzumab)~     in patients with relapsed or refractory (R/R) follicular lymphoma (FL). The first~     immunotherapy molecule investigated will be emactuzumab (Arm A) in two combinations.~   "
15047|NCT03369951|"~     This is a Phase IV, multi-center open-label pharmacokinetic trial studying the~     pharmacokinetics and pharmacodynamics of a single dose of Minocin IV. Up to 67 subjects will~     be enrolled to obtain 50 evaluable, ICU patients who are already receiving antimicrobial~     therapy for a known or suspected Gram-negative infection. The entire study duration will be~     approximately 12 months and each subject participation duration will be approximately 2 days~     depending on whether any follow-up is needed. The study will be conducted at approximately 10~     clinical sites. Each subject will receive a single 200 mg dose of Minocin IV infused over~     approximately 60 minutes. Each subject will have 7 PK samples collected (1 pre-dose, 6~     post-dose) at designated time points over a ~48 hour period following the start of the~     Minocin IV infusion. The primary objectives are: 1) To characterize minocycline PK at the~     population level in critically-ill adults, with illness known or suspected to be caused by~     infection with Gram-negative bacteria and 2) To assess patient-level and clinical covariates~     associated with minocycline pharmacokinetic properties in critically-ill adults, with illness~     known or suspected to be caused by infection with Gram-negative bacteria.~   "
15048|NCT03369938|"~     The objective of the study is to test whether 12 weeks of structured supervised exercise~     training on top of usual care improves functional capacity in patients with end-stage heart~     failure with continuous flow left ventricular assist device (LVAD).~   "
15049|NCT03369925|"~     The objective of this trial is to determine the effects of citicoline on cognitive~     performance in healthy Men and Women with Age-Associated Memory Impairment compared to a~     placebo.~   "
15050|NCT03369912|"~     The purpose of the study is to evaluate the feasibility of using CSJ148 to prevent congenital~     human cytomegalovirus (HCMV) in pregnant women with primary HCMV infection.~   "
15051|NCT03369899|"~     This study is a non-randomized, single-arm, multi-center study that is designed to evaluate~     the safety and effectiveness of the FreeStyle Libre Flash Glucose Monitoring Systems in~     pediatric populations.~   "
15052|NCT03369886|"~     Macular GCIPLT and vessel density will be measured with Spectralis optical coherence~     tomography and Topcon swept-source OCT respectively. Linear, quadratic and exponential~     regression models will be used to investigate relationship between GCIPLT and vessel density.~     Multilayer neural network will bel used to make single combined parameter and the diagnostic~     performance will be also compared.~   "
15053|NCT03369873|"~     This study´s objective was to identify the effectiveness of nursing orientation for the~     reduction of anxiety and stress of patients that was waiting cardiac catheterization. Method.~     This is a randomized clinical trial. The sample consisted of patients that was waiting~     cardiac catheterization who were divided into two groups: intervention group (patients who~     received nursing orientation with a validated guidance manual about this procedure) and~     control group (patients who received the routine nursing orientation). The primary end points~     were the anxiety and stress, which was evaluated in two moments (before and after the nursing~     orientation). The State Anxiety Inventory (STAI-state) was used to assess anxiety and the~     Perceived Stress Scale (PSS-10) was used to assess stress. Prior to the collection, the~     research project was submitted to the Research Ethics Committee and the data was collected~     after its approval.~   "
15054|NCT03369860|"~     The ability to interact with conspecifics is crucial in life, yet there is no consensus on~     the underlying cognitive and neural mechanisms beyond those associated with imitative~     behaviors. This project aims to define a coherent model of non-imitative (complementary)~     motor interactions. The investigators hypothesize that these might be substantially based on~     the ability to integrate one's own and a partner's action within a unitary, dual- person~     (dyadic), motor plan that incorporates a shared goal.~      With a novel minimally-joint paradigm the investigators will test this hypothesis and~     measure with behavioral measures (i.e., reaction times) whether the supposedly automatic~     tendency to imitate others is modulated by the need to coordinate with a partner to achieve a~     shared goal.~      This paradigm will be also applied during a functional MRI experiment to describe the~     underlying neurophysiological patterns; using dynamic causal modeling the investigators will~     measure how the brain regions relevant for dyadic motor control are functionally linked.~      This converging experimental strategy will permit to compare competing psychological and~     neural models of motor interactions in healthy participants, opening new experimental avenues~     for studies in adult neuropsychological patients and in children with typical and atypical~     social development.~   "
15055|NCT03369847|"~     This study evaluates the initiation of inhaled corticosteroids upon discharge from the~     pediatric emergency room in children under 18 presenting with asthma exacerbation. Half of~     the patients will receive a prescription for inhaled corticosteroids in addition to standard~     care, and half of the patients will receive standard card alone.~   "
15056|NCT03369834|"~     Diabetes mellitus (DM) is a metabolic disorder, characterized by hyperglycemia and metabolic~     disorders, resulting in changes in insulin secretion and / or action. Physical function is~     critical for functional independence, and chronic diseases such as diabetes can lead to~     functional decline, and diabetes mellitus is a major contributor to the progression of~     sarcopenia and physical disability. DM is also known to have a strong associated with the~     development of peripheral arterial disease. Peripheral arterial disease is characterized by~     obstruction of the arteries of the lower limbs, leading to a low oxygenation of the muscles~     of the lower extremities. Among the physiotherapeutic resources that can be used,~     phototherapy involves the use of light for the treatment of muscular injuries, by modulating~     the physiological processes associated with the repair process. Clinical trials show that LED~     is a technique that interferes with muscle strength, generating an increase in maximal~     voluntary contraction and peak torque. It is hypothesized that the LED application is capable~     of improving the muscular strength, fatigue, functional performance and blood flow~     capabilities in individuals with diabetes. It is also expected that the results of this study~     may contribute to and increase the resources used by physiotherapists within the clinical~     scope, contributing to the care of diabetic patients.~   "
15088|NCT03369418|"~     The investigators aim to use a CES (cranial electrotherapy stimulation) intervention to~     improve emotional well-being by reducing symptoms of anxiety and depression and to assess for~     changes in markers of cellular health - specifically, telomere length and telomerase activity~   "
18020|NCT03331068|"~     A specific scale allowing the measure of anxiety of patients with protate cancer has been~     designed and validated but the French version needs to be validated. This study aims at~     validating the French translation of this scale.~   "
15057|NCT03369821|"~     Type 1 diabetes (T1D) results from destruction of insulin-producing beta cells in the~     pancreas by the body's own immune system (autoimmunity). We do not fully understand what~     causes this type of diabetes and why there is variation in age of onset and severity between~     people who develop the disease. The aim of this work is to study very unusual people who~     develop T1D extremely young, as babies under 1 year of age. We think that, for the condition~     to have developed that early, they must have an unusual or extreme form of autoimmunity.~      Studying people with very early-onset diabetes will enable us to look at exactly what goes~     wrong with the immune system because they have one of the most extreme forms of the disease.~     We may be able to learn a lot about the disease from a small number of rare individuals. We~     aim to confirm that they have autoimmune type 1 diabetes and then try to understand how it is~     possible that they have developed diabetes so young by studying their immune system genes,~     the function of their immune system, and environmental factors (such as maternal genetics)~     that may play a role in their development of the disease.~      People with diabetes diagnosed under 12 months are very rare and they live all over the~     world. We will take advantage of the fact that they are usually referred to Exeter for~     genetic testing. As part of their wider clinical team, we will contact them via their~     clinician to ask for more information about their diabetes and their family history. We will~     collect samples to study whether they still make any of their own insulin and whether they~     make specific antibodies against their beta cells in the pancreas. Separately, we will study~     their immune system in depth using immune cells isolated from a blood sample. We will then~     study these cells using cutting edge techniques by Dr Tim Tree at King's College London, by~     Professor Bart Roep at the Diabetes Metabolism Research Institute Faculty, City of Hope~     National Medical Center, California (USA), and Dr Cate Speake, Benaroya Reseach Institute,~     Seattle (USA). Some of these tests have never been used in people of young ages around the~     world, so an aim of this project will be to develop methods that can be used to study people~     even if they live far away.~   "
15058|NCT03369808|"~     The aim of this study is to investigate the immunogenicity and safety of the inactivated~     whole-virion vaccine for teenagers and adults.~      The investigators will test the vaccine in participants aged 12-60 years, for a randomized,~     blind, placebo-controlled, age-stratified clinical study. The investigators designed three~     dosage groups: 7.5 μg,15 μg and 30 μg of hemagglutinin antigen. According to the age of the~     subjects, Each group was divided into different age subgroups. Phosphate buffer solution and~     Aluminum hydroxide adjuvant as placebo controls were both set up in the~     subgroups.Participants will receive 2 doses of vaccine at 21-day intervals.Safety up to 6~     months and changes in hemagglutinin inhibition (HI) titers at 21 days after each vaccination~     were determined.~   "
15059|NCT03369795|"~     A recent double-blind placebo-controlled study has tested the effect of methotrexate as an~     add-on treatment for patients with schizophrenia or schizoaffective disorder, administering~     10 mg of methotrexate or placebo once a week for a period of three months to 72 patients~     (Chaudry, Husain et al. 2015). Results showed improvement both in positive symptoms, as~     measured by the Positive symptoms subscale of the Positive and Negative Syndrome Scale~     (PANSS), and in total PANSS scores.~      The objective of this study is to replicate Chaudry et al.'s study. This proposed study will~     randomize schizophrenia or schizoaffective disorder patients to methotrexate or placebo for a~     period of four months.~      The study will enroll patients with a DSM-IV-TR diagnosis of schizophrenia or schizoaffective~     disorder confirmed by the Modified Structured Clinical Interview for Diagnosis (SCID). In~     order to be eligible to enter the study, the patient must have a score of 4 (moderately ill)~     or greater on the Clinical Global Impression - Severity (CGI-S) scale. In addition, inclusion~     criteria reflect patients with moderate or more severity on positive symptoms, hence having a~     score of 4 (moderate) or above on two of the following four PANSS items: delusions,~     hallucinatory behaviors, conceptual disorganization or suspiciousness/ persecution. Patients~     receiving more than one anti-psychotic or depot antipsychotic will be allowed to participate,~     and patients receiving anti-cholinergic agents, beta-blockers, anti-depressants,~     mood-stabilizers, sedatives, and anti-anxiety agents will be allowed in the study. Because~     the clinical status of patients sometimes improves in the days following admission to the~     hospital, newly hospitalized patients will have their baseline visit 3 days or more after~     being hospitalized.~   "
15060|NCT03369782|"~     During Total hip replacement arthroplasty (THA), the hip joint first must be luxated in order~     to have access to the joints. A lot of force and torque must be carried out on the joint to~     perform this manipulation. This is both difficult for the surgeon and may cause additional~     tissue damage and postoperative pain. After placement of the prosthesis and reduction of the~     joint, the tension of the hip joint must be evaluated by the surgeon to ascertain the~     adequacy of the prosthesis. During luxation, minimal muscle tension would be ideal, while~     after reduction of the joint, normal muscle tension is desired to permit assessment of the~     mechanics of the hip joint.~      The aim of the study is to investigate whether deep neuromuscular block, combined with a~     reversal before mechanics assessment improves surgical conditions, surgical time, and~     postoperative patient comfort.~   "
15061|NCT03369769|"~     Background: Children with Autism Spectrum Disorder (ASD) are at higher risk for developing~     co-existing mental health conditions and consequently experiencing psychiatric~     hospitalization, compared to the general pediatric population. However, hospital environments~     can be exceptionally stressful for this population, given their social-communication~     deficits, ineffective emotional regulation skills and heightened physiological arousal. While~     the use of animal-assisted activities (AAA) show potential for various improvements in~     children with ASD in community settings, these stress-reducing and social-buffering~     benefits have not yet been studied within a psychiatric hospital setting for youth with ASD.~      Objectives: Evaluate whether an AAA with canines can lead to reduced physiological arousal~     and improvements in social-communication as well as aberrant behaviors in children and~     adolescents diagnosed with ASD in a specialized psychiatric hospital setting.~      Methods: Participants were recruited from the Neuropsychiatric Special Care (NSC) program's~     inpatient and/or partial day-treatment program. Prior to study participation, baseline~     demographic measures were acquired from caregivers and participants' ASD diagnosis was~     confirmed. Participants experienced two, randomly assigned 35-minute sessions (AAA and~     Control Condition) with a minimum two-day washout period between groups. Each session~     included a baseline 20-minute social skills group immediately followed by a 10 minute~     experimental or control condition. The AAA condition introduced a canine and volunteer~     handler for free interaction time while the control condition introduced a novel toy and a~     volunteer for free interaction. Participants' physiological arousal was continuously assessed~     throughout all conditions via the Empatica E-4 wristbands (Empatica Inc. 2014). All sessions~     were videotaped for behavioral coding using the Observation of Human Animal Interaction for~     Research - Modified, v.1.~   "
15062|NCT03369756|"~     This study evaluates the use of Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel~     in the treatment of chronic leg wounds in adults. All participants will use Prontosan and~     report their personal observations regarding Quality of Life.~   "
15089|NCT03369405|"~     Currently, the investigators are unaware of any previous studies that have analyzed the~     relationship between the prevalence of thyroid disease and chronic periodontitis among adults~     utilizing a retrospective, cross-sectional design. This study will review approximately 2000~     patient records and compare the prevalence of thyroid disease in three groups with increasing~     severity of chronic periodontitis.~   "
22302|NCT03275116|"~     To study the effect of twice daily dual bronchodilation versus once daily single~     bronchodilation in patients with chronic obstructive pulmonary disease on 24-hour static and~     dynamic hyperinflation.~   "
15063|NCT03369743|"~     Efficacy of etravirin + raltegravir dual therapy was showed in the ANRS 153 ETRAL protocol,~     in HIV-1 seropositive patients. The use of these two drugs avoids the use of nucleoside~     reverse transcriptase inhibitors and protease inhibitors, with a real benefit in older~     patients, who increasingly present contraindications to these drugs' families. The~     disadvantage of this strategy is twice daily (BID). Pharmacological data suggest that~     etravirine once a day and raltegravir once a day may provide the same virological efficacy.~      The objective of our study is to evaluate the ability of ETRAL QD (etravirine 400 mg x1/day +~     raltegravir 800 mg x1/day) to maintain virologic success at week 48 (W48), after switch, in~     HIV-patients under ETRAL BID (etravirine 200 mg x2/day + raltegravir 400 mg x2/day).~     Virological success is defined as absence of virological failure, and virological failure is~     defined as two consecutive plasma viral loads >50 cp/ml over 2-4 weeks, or one plasma viral~     load >400 cp/ml.~      This study will be a multicentric data collection. Data will be collected at W0 (patient~     characteristics, plasma viral load) and then at W4, W12, W24 and W48 (plasma viral load). If~     stopping strategy, the reason for stopping will be documented. 125 patients will be included~     in the six participating centers. Data will be centralized at Pitié-Salpêtrière hospital,~     Paris, with an anonymized e-CRF.~   "
15064|NCT03369730|"~     The goal of this project is to investigate whether a systematic screening approach for~     individuals with first episode psychosis (FEP) can substantially reduce Duration of Untreated~     Psychosis (DUP). The study team will evaluate the feasibility of screening a consecutive~     help-seeking population entering mental health services in order to facilitate early~     identification of FEP cases, rapid referral to specialty care and engagement in treatment.~   "
15065|NCT03369717|"~     The objective of this study is to determine whether the use of postoperative antibiotics~     following ESS decreases postoperative infection rates. This is a multi-institutional~     prospective study involving Albert Einstein College of Medicine/Montefiore Medical Center,~     Columbia University Medical Center, Weill Cornell Medical College, Mount Sinai Health System,~     and New York University Langone Medical Center. The study design will be a~     multi-institutional prospective randomized controlled trial with parallel random groups~     assigned to receive postoperative antibiotics or no postoperative antibiotics. The~     investigators hypothesize that patients who receive postoperative antibiotics will have lower~     postoperative infection rates and improved postoperative sinonasal symptoms and nasal~     endoscopy scores.~   "
15066|NCT03369704|"~     The purpose of this study is to demonstrate the efficacy and safety of omalizumab compared~     with placebo, on top of SoC (anti-histamine and nasal corticosteroid) in adult and adolescent~     patients with severe Japanese cedar pollinosis, whose symptoms were inadequately controlled~     despite the current recommended therapies (nasal corticosteroids plus one or more medications~     out of anti-histamine, leukotriene receptor antagonist, or prostaglandin D2/thromboxane A2~     receptor antagonist) in the previous 2 Japanese cedar pollen seasons.~   "
15067|NCT03369691|"~     The study will examine the mechanisms linking race, stress and biobehavioral factors to~     energy balance and obesity in both natural and controlled environments in African-American~     and Caucasian adolescent females.~   "
15068|NCT03369678|"~     Emergency Departments (EDs) in Canada often operate over-capacity and are under significant~     pressures. In this environment, particular groups of people experience inadequate and~     inequitable treatment in EDs, including Indigenous people, racialized newcomers, people with~     mental illnesses, those living in unstable housing or facing homelessness, experiencing~     interpersonal violence or using substances, and people involved in sex work. Stigma and~     discrimination in health care deter people from accessing care, interfering with effective~     care delivery, increasing reliance on EDs, and increasing human and financial costs. This~     project will develop and test a framework for health equity interventions to promote the~     provision of equity-oriented care in EDs.~   "
15069|NCT03369665|"~     The main purpose of the study is to assess the health-related quality of life (HRQoL) through~     the Multiple Sclerosis Quality of Life-54 Questionnaire (MSQoL-54) scale in highly-active~     relapsing multiple sclerosis (RMS) subjects treated with Mavenclad® for 2 years (24 months).~   "
15070|NCT03369652|"~     In this trial, the feasibility of cooperation between clinical pharmacists and physicians by~     conducting a telephone follow-up conversation between the hospital geriatrician, the general~     practitioner and the clinical pharmacist is evaluated. During hospital stay the clinical~     pharmacist and the geriatrician will review older patients' medication and discuss the future~     treatment with the general practitioner after discharge by telephone or medico-technology.~      The first part of the feasibility study will be a qualitative baseline measure of~     characteristics of the participants and work flow. The second part will be a pilot randomized~     controlled study where participants will be allocated to either usual care or medication~     review and follow up contact~   "
15071|NCT03369639|"~     This is an observational study evaluating the safety and efficacy of dronabinol for the~     treatment of anxiety and/or depression in older adults. Participants who are prescribed~     dronabinol as part of a voluntary inpatient stay in McLean's Division of Geriatric Psychiatry~     will be interviewed about their mood and cognition on a weekly basis while on dronabinol.~   "
15072|NCT03369626|"~     A clinical study evaluating a three month digitally delivered lifestyle change program in~     adults with Type 2 Diabetes. The FareWell Program (the Program) aims to reduce~     well-established biomarkers of cardiometabolic diseases, weight, and medications. The current~     study is designed to evaluate to what degree adults with Type 2 Diabetes engaged with the~     Program can improve glycemic control and/or decrease medication needs.~   "
15073|NCT03369613|"~     There are two phases.~      Phase I: A single visit which includes a screening, clinical scales, and a MRI scan with~     simultaneous tES/sham tES in a randomized block design. Enrolls both Cervical Dystonia (CD)~     patients and healthy controls.~      Phase II: 5 consecutive days of 30-90 min visits to campus for tES or sham tES. Transcranial~     magnetic stimulation (TMS) measures and clinical scales will also be included on Day 1 and~     Day 5 visits. Enrolls only CD patients.~   "
15141|NCT03368716|"~     The overarching aims of this project are to develop and pilot test a novel, patient-centered,~     family model for weight management [Acceptance-based Behavioral Treatment (ABBT)] in children~     aged 8-12 with obesity and their caregivers. Our aims are (1) to determine the treatment~     needs of children aged 8-12 with obesity and their families with a focus on executive~     functioning and (2) to evaluate the feasibility and acceptability of family ABBT.~   "
15074|NCT03369600|"~     Over half of the female population will suffer from fibroids, benign tumors of the uterus,~     before menopause, a third of whom experience significant symptoms which lower their quality~     of life. Fibroids can range from being extremely stiff tumors to soft, cyst-like, or mushy~     masses. Currently, surgical planning for fibroid treatment is done using ultrasound or MRI,~     which inform physicians of fibroid position and size, but omit any information regarding~     tissue stiffness or composition, which can impact surgical techniques and approaches.~     Elastography is a new, affordable imaging modality currently being used in cancer research,~     and is able to measure tissue stiffness non-invasively. We propose a preliminary assessment~     of elastography for application in screening fibroids in pre-menopausal women. This study~     will assess elastography as a valid and reliable tool for measuring fibroid and uterine~     tissue stiffness, with the long-term goal of classifying fibroid tissues to aid in surgical~     planning. We hypothesize that between-day and within-day measures of tissue stiffness taken~     using elastography will show excellent reliability and will correlate with experimental~     measures of tissue stiffness.~   "
15075|NCT03369587|"~     Background: Problems with handwriting are frustrating and debilitating and affect the~     majority of people with Parkinson's. Manifest as micrographia it is a distinctive feature of~     the condition characterised by small handwriting and/or a progressive reduction in size~     through a sentence[2] coupled with a reduction in writing speed and legibility.~      In Parkinson's impaired automaticity is thought to contribute to handwriting deficits and~     attention has been shown to improve both 'consistent' (small handwriting) and 'progressive'~     (progressive reduction in letter size through a sentence) aspects of the symptom. Moreover,~     recent interventional studies indicate handwriting may be improved through practice. This~     study is investigating a novel handwriting practice stimulus to improve symptoms of~     micrograpthia~      Question: Is a diverging line cued handwriting intervention potentially more effective at~     improving symptoms of mircograpthia than a parallel line cued handwriting intervention in~     people with Parkinson's?~      Specifically, an assessor blind randomised controlled exploratory trial will:~        1. Estatimate the effect of the intervention on measures of: Handwriting amplitude~          (consistent and progressive reduction), hand writing performance and percieved~          handwriting difficulties.~        2. Explore the appropriateness of these outcome measures~        3. Explore the approriateness of eligibilty criteria~        4. Explore intervention fidelity~        5. Explore participants views of the intervention~      Design: A phase II exploratory randomised controlled trial of a handwriting intervention with~     an active comparator control group and blinded assessments~      Setting: The intervention will be carried out at home~      Sample size: This study is not designed to determine efficacy. The aim to recruit a total of~     50 people (25 people per group) in order to estimate the effects on outcome measures and~     achieve the aims of this exploratory trial.~      Assessment: Participants will be asked to follow their usual Parkinson's medication regime~     and if they have ON and OFF periods, assessments will be carried out during ON state.~      Duration and follow-up: the assessment is schedule 0Weeks (baseline), 6weeks (end~     intervention) and 12weeks (follow up). Assessments will be carried out by a researcher blind~     to trial arm allocation using all outcome measures.~   "
15076|NCT03369574|"~     The primary objective of this research is to monitor chronic rhinosinusitis (CRS) symptoms in~     asthma patients who are undergoing treatment with reslizumab. A secondary objective is to~     explore whether there are sub-populations that appear to benefit or not benefit from~     reslizumab in terms of their CRS symptoms.~   "
15077|NCT03369561|"~     The cardio renal syndrome generally focuses on left ventricular function, and the importance~     of the right ventricle as a determinant of renal function is described less frequently.~     Although the risk of AKI is similar for patients with isolated LVD and isolated RVD, the~     severity of AKI and the associated risk of hospital mortality is highest among those with~     isolated RVD.~   "
15078|NCT03369548|"~     During digestion of fatty foods, the liver produces a substance called bile which helps with~     the absorption of fat in the gut (small intestine). Some research studies have shown that~     friendly bacteria that live in our gut can change the makeup of bile (referred to as bile~     acids) leading to a lowering of blood cholesterol levels, an important risk factor for~     developing heart disease. This finding has been found in people who consume diets high in~     dietary fibers and probiotics that enhance the growth of friendly gut bacteria, and also~     plant rich foods high in polyphenols (such as apples). At present, very little is known about~     how the makeup of bile acids can regulate blood cholesterol levels and if their measurement~     in blood, urine or stool samples can be used as an indicator of human health.~      The aim of this study is to explore how consumption of foods which enhance the growth of~     friendly gut bacteria (such as probiotics, prebiotics, and plant rich foods high in~     polyphenols) can change the makeup of bile acids after 8 weeks. Changes in the bile acids~     measured in blood and stool samples will then be related to markers of health, such as blood~     cholesterol, glucose, insulin, vascular health and inflammatory markers.~   "
15079|NCT03369535|"~     To compare the urinary metabolomes on individuals undergone three different healthy diets--a~     carbohydrate-rich diet, a protein-rich diet, or a diet rich in unsaturated fat.~   "
15080|NCT03369522|"~     The aim of our project is to develop an epileptic seizure detection algorithm based on the~     the continuous analysis of the Electrocardiogram~   "
15081|NCT03369509|"~     The creation of a database containing the medical data of patients followed in allergology at~     the University Hospital of Grenoble will permit to study allergic versus non-allergic~     hypersensitivity drug reaction as well as the risk of cross-reactions between medicinal drugs~     belonging to the same pharmacological class.~      The main objectives of the study are to estimate and to compare the proportion of allergic~     hypersensitivity drug reaction and the proportion of non allergic hypersensitivity drug~     reaction, and to characterize these two types of hypersensitivity drug reaction on clinical,~     biological and chronological aspects.~      In a second time, ancillary study will be conducted in order to :~        -  identify drugs that potentially induced histamine-liberation in patients diagnosed with~          non allergic hypersensitivity drug reaction~        -  investigate the risk of cross-reactions between drugs belonging to the same~          pharmacotherapeutic class in patients diagnosed with allergic hypersensitivity drug~          reaction.~   "
15090|NCT03369392|"~     Despite the numerous benefits of peripheral nerve blocks (PNBs) over general anesthesia (GA)~     in a variety of surgical procedures, PNBs can be associated with increased post-operative~     pain if pain medications are not taken correctly (titrated). Unfortunately, this is a common~     occurrence as patients often have difficulty titrating medications in the absence of direct~     medical care. PANDA, a smartphone-based postoperative pain management tool, is designed to~     address this issue by helping patients manage their pain medications. The purpose of this~     study is to demonstrate the feasibility of this application in patients who are discharged~     after receiving PNBs. The goal is to identify areas of improvement for the application~     itself. It is hypothesize that PANDA will be successful in supporting patients' postoperative~     pain management.~   "
15142|NCT03368703|"~     Patients with COPD have lower cortical activation and higher cortical inhibitory levels. The~     purpose of this study is to test the reversibility the lower cortical activation by~     counterbalancing the increased cortical inhibitory levels with neuro-modulation.~   "
15082|NCT03369496|"~     Social networks, social capital, i.e., network-accessed resources, and neighbourhood~     environments have been shown associated with a range of health behaviours and conditions,~     including obesity, physical activity, nutrition, and mental health. Research on social~     capital and health in Montreal has shown the importance of network social capital for a~     person's subjective health status, sense of control, self-reported physical activity, and~     obesity. Research has also shown high social capital to reduce health service use, mental~     health service use, and improve the management of chronic illnesses. Despite advances in the~     understanding of social capital and its link to health and health service use, most research~     on social capital is cross sectional and is unable to identify the causal pathways linking~     social networks and capital to health and health care use. Longitudinal research would~     strengthen the evidence base for designing interventions to prevent or delay the use of~     health services, particularly in older adults.~      This research has three main objectives: (1) transform the original sample of Montreal~     Neighbourhood Networks and Healthy Aging (MoNNET-HA) households (n=2707) into a panel study,~     (2) link the MoNNET-HA participant data to their Quebec Health Insurance Registry (Régie de~     l'assurance maladie (RAMQ)) information, and (3) assess the feasibility of extending the~     MoNNET-HA panel by one wave to include participant's core network members. Unique about the~     original MoNNET-HA sample is that it purposefully oversampled older adults (> 64 years old)~     but remains representative of Montreal adults at various ages and income levels. In addition,~     MoNNET-HA data is integrated into a GIS database which allows researchers to examine the~     effects of neighbourhood environmental characteristics on health. By linking MoNNET-HA data~     to RAMQ, researchers will be able to examine patterns of diagnosed health conditions, (e.g.,~     fractures, depression), pharmaceutical use and adherence, and formal health care use over~     time. Transforming the cross-sectional study into a panel study would also allow researchers~     to examine longitudinally the dynamics of health and health care utilization among Panel~     participants over the life course, and the causal pathways linking neighbourhoods and~     networks to health and health care use.~   "
15083|NCT03369483|"~     During abdominal surgery, the intra abdominal pressure may increase determining lung bibasal~     atelectasis. The investigators hypothesized that the application of Positive End Expiratory~     Pressure (PEEP) promptly after extubation through Continuous Positive Airway Pressure (CPAP)~     would improved gas exchange, especially in those patients with abdominal pressure values~     close to those applied by CPAP.~      The investigators have therefore designed this subset study enrolling patients randomized to~     receive CPAP in the Prevention of Respiratory Insufficiency after Surgical Management~     (PRISM) Trial in order to ascertain the abdominal pressure in post-surgical patients~     (abdominal open surgery procedures) enrolled in PRISM trial. In addition they would evaluate~     the effects of CPAP on abdominal pressure and consequently on arterial blood gas, and whether~     there is a correlation between PEEP values, abdominal pressure values and arterial blood gas.~      One hundred patients included in CPAP group of the PRISM trial will be enrolled in this~     subset study. The investigators will perform measurements of the abdominal pressure an~     urinary catheter connected with an intra-abdominal pressure device (Uno-Meter ® -~     Uno-medical) in all patients undergoing on open-surgical procedures after mechanical~     ventilation withdrawal and extubation, 30 minutes and 4 hours after the application of CPAP.~   "
15084|NCT03369470|"~     Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system and~     the most common cause of non-traumatic disability in young adults (Kamm et al. 2014;~     Vanbellingen & Kamm, 2016). It is a heterogeneous disease, which is associated with long-term~     disability, leading to reduced quality of life (QoL). Disease-modifying pharmacological~     therapies (DMT) decrease activity and progression of the disease, and symptomatic~     pharmacological treatments reduce complaints to a certain extent, however MS patients often~     still suffer from various neurological deficits during the course of their disease (Kamm et~     al. 2014). Consequently, specific non-pharmacological therapies are needed in order to~     further reduce disability, eventually resulting in better QoL (Lamers et al. 2016;~     Vanbellingen & Kamm, 2016).~      Impaired dexterity is a frequently observed impairment, affecting up to 76% of patients with~     MS (Johannson et al. 2007). The different neurological deficits caused by MS, such as ataxia,~     spasticity, sensory-motor deficits, and apraxia may be alone or in combination, impair manual~     dexterity (Kamm et al. 2012; Heldner, Vanbellingen et al. 2014). MS patients experience~     impairments in the performance of several activities of daily living (ADL), such as grooming,~     cooking, etc. Sometimes these problems are even associated with loss of work, and lack of~     social integration (Chruzander et al. 2013).~      The effectiveness of the app based exercises still needs to be proven. With respect to~     dexterity, a first new app has been developed called Finger Zirkus, by a team of experts~     including an occupational therapist, graphic designer, and IT expert. The app is already~     available to be downloaded from google play store or apple store (see for more details:~     www.fingers-in-motion.de).~   "
15085|NCT03369457|"~     The aim of hip replacement surgery is to re-establish the physiological hip function and to~     obtain a stable fixation between the prosthetic components and the native bone. Commonly, the~     fixation is obtained by bone ingrowth between the prosthesis and the native bone. Thus, the~     quality of the patient's bone stock is essential to achieve this aim. However, several~     clinical conditions may impair the bone stock; therefore, in these cases bone grafts are~     necessary to improve the prosthetic fixation. The gold standard is represented by autologous~     bone grafts (from iliac crest or from acetabular bone chips) or allogeneic bone grafts from~     cadaveric femoral heads. Nevertheless, the osteogenic potential of multipotent cells derived~     from different anatomical regions has never been examined.~      Thus, the aim of this study is to isolate multipotent cells from acetabular or femoral bone~     chips and from bone marrow aspirate of the same patient and to compare their osteogenic~     potential. The results of this study may reveal differences, which may have a clinical~     relevance for hip replacement surgery.~   "
15086|NCT03369444|"~     Severe haemophilia B is a bleeding disorder where a protein made by the body to help make~     blood clot is either partly or completely missing. This protein is called a clotting factor;~     with severe haemophilia B, levels of clotting factor IX (FIX) (nine) are very low and~     affected individuals can suffer life threatening bleeding episodes. HB mainly affects boys~     and men (normally one in every 30,000 males). Current treatment for HB involves intravenous~     infusions of factor IX as regular treatment (Prophylaxis) or 'on demand'. On demand treatment~     is highly effective at stopping bleeding but cannot fully reverse long-term damage that~     follows after a bleed. Regular treatment can prevent bleeding, however can be invasive for~     patients and also expensive. This research study aims to test the safety and effectiveness of~     a gene therapy which produces Factor IX protein in the body. The gene will be given using an~     inactivated virus called the vector ( FLT180a), in a single infusion. The vector has been~     developed from a virus known as an adeno- associated virus, that has been changed so that it~     is unable to cause a viral infection in humans. This inactivated virus is further altered~     to carry the Factor IX gene and to make its way within liver cells where Factor IX protein is~     normally made.~      Up to three different doses of FLT180a will be tested, in up to 18 patients with severe~     haemophilia B. Patients will be recruited from haemophilia centres in the EU and US. Patients~     will be in the trial for approximately 40 weeks and will undergo procedures including~     physical examinations, bloods tests, ECGs and liver ultrasounds.~   "
15091|NCT03369379|"~     Fibromyalgia is a disease that significantly decreases the quality of life of people who~     suffer from it, has great repercussions at the socio-economic level due to the incapacity it~     produces. It is characterized by generalized pain, fatigue, sleep disorders, psychological~     stress and mental alterations, besides presenting painful points in different parts of the~     body to physical examination. Having few effective treatments is necessary to explore new~     options in their management to improve the general conditions of the patient. Previous~     studies have shown that patients with fibromyalgia have had low levels of vitamin D in the~     blood, a favorable response from post-vitamin D supplementation has been seen. This vitamin~     has been associated with pain pathways and with increased The perception of the same when it~     is in smaller amount. We will select patients with Fibromyalgia diagnosis from the external~     consultation of Rheumatology of the University Hospital Dr. José Eleuterio González of the~     UANL, over 18 years old who have not been previously supplemented with vitamin D, will~     initially be measured in blood of vitamin D, in addition to calcium as a safety measure, we~     will have a group that will only receive placebo and Another that will be supplemented with~     50 thousand units weekly for 12 weeks, we will apply a questionnaire that measures pain scale~     and another one that measures the impact of the disease in the daily life of the patient,~     this will be done in a beginning and at the end of the 12 weeks .~   "
15092|NCT03369366|"~     Immediate reconstruction and dental rehabilitation of maxillofacial ablative defects with~     patient specific reconstruction plates, dental implants, and immediate load provisional~     screw-retained prosthesis will improve patient short and long term outcomes and improve~     patient quality of life. Utilizing current technologic advances, patients undergoing large~     ablative procedures for benign head and neck pathology can now not only have immediate bone~     and soft tissue reconstruction, but dental rehabilitation as well. Using virtual surgical~     planning, patient specific selective laser melded reconstruction plates, and dental implants,~     a screw-retained provisional dental restoration can be fabricated and placed during a~     one-stage procedure with minimal to no intra-operative prosthetic work required.~   "
15093|NCT03369353|"~     The goal of the PREDICT trial is to apply a systems-biology approach to enable precision~     diagnostics for the key immunologic outcomes post-transplant. This approach will deepen the~     understanding of the molecular mechanisms driving the most deadly post-transplant~     complications, and serve as a critical platform upon which to design evidence-based treatment~     paradigms for transplant patients.~      This research study will examine the immunology of different gastrointestinal disturbances~     such as Inflammatory Bowel Disease (IBD), Graft-versus-Host Disease (GVHD), and Functional~     Gastrointestinal Disorder (FGID). The Investigators want to know why and how people develop~     these gastrointestinal disturbances using blood and tissue samples in order to better predict~     and treat the disease process.~      The Investigators hypothesize that they can define the mechanisms responsible for~     gastrointestinal (GI) acute GVHD and differentiate it from other inflammatory disorders by~     using advanced immunologic analysis.~      The Investigators further hypothesize that longitudinal systems-based immunologic analysis~     will enable the patient-specific determination of the molecular evolution of acute and~     chronic GVHD as well post-transplant defects in protective immunity, and determine which~     pathways, when perturbed, can cause clinical disease. The discovery of these pathways will~     lead to improved diagnostic, prognostic and treatment approaches, and to personalized~     therapeutic decision-making for patients undergoing hematopoietic stem cell transplantation~     (HCT).~   "
15094|NCT03369340|"~     This is a single-center, open-label, randomized, crossover study to evaluate the~     pharmacokinetic (PK) profiles of four P3P variants, following a fixed puffing regimen and an~     ad libitum use period. In addition, pharmacodynamic (PD) effects (subjective effects and~     related behavioral assessments), as well as human puffing topography, will be evaluated, to~     provide further insights on product acceptance and product use.~   "
15095|NCT03369327|"~     In a multi-center study 200 patients co-infected with hepatitis C virus (HCV) and human~     immunodeficiency virus (HIV) will be treated with a fixed-dose combination pill combined of~     400 mg sofosbuvir and 30, 60, or 90 mg of daclatasvir - depending on the particular~     antiretroviral treatment (ART) being used by the patient. The treatment duration will be 12~     weeks for subjects without cirrhosis and 24 weeks for those with cirrhosis.~   "
15096|NCT03369314|"~     This observational study enrolls patients who have received at least one infusion of~     octaplasLG®. OctaplasLG® will be administered standard of care and observation occurs during~     the treatment and 24 hours after the end of treatment. Characteristics of the use of~     octaplasLG®, tolerance criteria, and efficacy criteria will be collected.~   "
15097|NCT03369301|"~     Patients with Myeloma or CLL with severe secondary hypogammaglobinemia and recurrent~     infections will be included in this study; for whom an IgSC treatment was prescribed. The~     IgSC prescription will be the decision of the treating physician. Patient care and follow up~     will be performed according to the current clinical practice and the recommendations of HAS.~   "
15098|NCT03369288|"~     3-year PET-MRI follow-up after vertebral balloon kyphoplasty aiming to investigate cement~     incorporation.~   "
15099|NCT03369275|"~     Septic shock is associated with substantial burden in terms of both mortality and morbidity~     for survivors of this illness. Pre-clinical sepsis studies suggest that mesenchymal stem~     (stromal) cells may modulate inflammation, enhance pathogen clearance and tissue repair and~     reduce death. Our team has completed a Phase I dose escalation and safety clinical trial that~     evaluated mesenchymal stem cells (MSCs) in patients with septic shock. The Cellular~     Immunotherapy for Septic Shock (CISS) trial established that MSCs appear safe and that a~     randomized controlled trial (RCT) is feasible. Based on these data, the investigators have~     planned a phase II RCT (CISS2) at several Canadian academic centres which will evaluate~     safety, signals for clinical efficacy, and continue to examine potential mechanisms of action~     and biological effects of MSCs in septic shock.~   "
15120|NCT03368989|"~     To describe the changes seen on bone scan and correlate them with changes in relative~     chemical biomarkers, patient's functional status and level of pain.~   "
15121|NCT03368976|"~     Study to collect videos of ultrasound recordings during peripheral nerve block procedures.~   "
15143|NCT03368690|"~     In this study, the investigators will investigate the effects of polyphenolic extract from~     pine bark on the inattention and hyperactivity in patients with attention deficit~     hyperactivity disorder (ADHD) based on antioxidative status.~   "
15100|NCT03369262|"~     This is a proof-of-concept study in 2 parts.~      In Part A, patients will receive OBE022 open-label in order to assess the safety and~     pharmacokinetics in pregnant women with spontaneous preterm labour with a gestational age~     between 28 0/7 and 33 6/7 weeks.~      Part B has a double-blind, randomised, placebo controlled, parallel group and multicentre~     design and will assess the efficacy, safety and pharmacokinetics in pregnant women with~     threatened spontaneous preterm labour with a gestational age between 24 0/7 and 33 6/7 weeks.~      All patients in part A and part B must receive atosiban infusion for 48 hours as standard of~     care treatment. Patients from Part A will receive OBE022 open label. Patients from Part B~     will be randomised to receive OBE022 or matching placebo. IMP treatment duration will be up~     to 7 days. IMP treatment will be stopped in case of delivery prior to Day 7.~   "
15101|NCT03369249|"~     This research study proposes to embed HIV testing outreach workers from a young adult focused~     medical and HIV treatment program into an alternative sentencing program to deliver a new~     service delivery model (Link2CARE) that integrates evidence-based protocols for~     justice-involved young adults to: a) promote HIV and STI testing, and HIV and SU risk~     screening, b) provide onsite intervention, and c) cross-system linkage to HIV, STI, and SU~     care. Phase 1 has already been completed. In phase 1, the intervention components were~     adapted for use among justice involved young adults and the resulting protocols were piloted~     with justice involved young adults, finalizing the resulting 4-session Link2CARE~     intervention. In phase 2, we will test Link2CARE among N=450 justice-involved young adults~     enrolled at the alternative sentencing program and conduct process evaluations with N=15~     alternative sentencing program staff.~   "
15102|NCT03369236|"~     The primary purpose of this proof of concept clinical study is to evaluate the efficacy and~     safety of the study drug, ACH-0144471, in participants who have been diagnosed with either~     C3GN or dense deposit disease (DDD) based on renal biopsy. Participants will be randomized~     1:1 to receive either study drug ACH-0144471 or placebo for a period of 6 months.~   "
15103|NCT03369223|"~     The purpose of this study is to determine whether BMS-986249 both by itself and in~     combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors~   "
15104|NCT03369210|"~     In this prospective, multicentre, open, randomised, controlled clinical trial elderly~     patients (≥ 70 years) undergoing intermediate- or high-risk non-cardiac surgery will be~     randomised either to a liberal group (patients receive a RBC unit each time Hb falls ≤ 9 g/dl~     (≤ 5.6mmol/l) with a target range for the post-transfusion Hb level of 9-10.5 g/dl (5.6-6.5~     mmol/l)) or restrictive group (patients receive a single RBC unit each time Hb falls ≤ 7.5~     g/dl (≤ 4.7 mmol/l) with a target range for the post-transfusion Hb level of 7.5-9 g/dl~     (4.7-5.6 mmol/l). Primary efficacy endpoint: is a composite of death from any cause and~     anaemia-associated, ischaemic events (defined as acute myocardial infarction, acute ischaemic~     stroke, acute kidney injury stage III, acute mesenteric ischaemia, acute peripheral vascular~     ischaemia) within 90 days after surgery.~   "
15105|NCT03369197|"~     This study is a randomized controlled trial comparing oxygen delivery by nasal mask with~     continuous positive airway pressure versus standard care (nasal cannula or standard facemask)~     during propofol-based sedation for gastrointestinal endoscopy procedures to reduce the~     incidence of hypoxia. The primary outcome will be the rate of oxygen desaturation below 90%~     for ≥15 seconds.~   "
15106|NCT03369184|"~     Supplemental oxygen is frequently used in patients admitted to hospital due to ischemic heart~     disease. In the setting of suspected myocardial infarction, clinical practice guidelines~     advocate the use of supplementary oxygen even in patients with normal levels of peripheral~     oxygen saturation. The theoretical basis for this practice is that an increase in blood~     oxygen content may limit ischemia and final myocardial damage and subsequent infarct size.~     However, although some experimental laboratory data and small studies in humans have~     supported the use of supplemental oxygen in patients with coronary artery disease,~     contradicting evidence suggests possible harmful effects, mainly through mechanisms involving~     coronary vasoconstriction and reduction of myocardial perfusion (hyperoxemic coronary~     vasoconstriction).~      In the EPOXY-IMR trial, the investigators aim to further explore possible detrimental effects~     from routine use of supplemental oxygen on the coronary circulation with special focus on the~     small vessels referred to as the coronary microcirculation.~   "
15107|NCT03369171|"~     Multiple sclerosis (MS) is a leading cause of neurological injury in young adults. Capturing~     the extent of multiple domains of MS-related disability is critical for effective clinical~     care and the development of new paradigms for patient-focused therapeutic approaches. To date~     outcomes research in MS has centered on clinical exams, which may be insensitive over the~     short term (the 1-2 years of early stage clinical trials) and only capture a single snapshot~     of the patient's performance.~      With the mass production of sensors in the gaming and computer control industry, there is an~     opportunity to transform the traditional neurological exam with biosensors already in use~     outside the realm of health applications. The investigators herein propose to use a~     commercialized wearable electroMYOgraphy sensor (MYO,Thalamic Labs Inc, Kitchener, ON,~     Canada) for detection of upper and lower limb dysfunction in MS patients. The investigators~     will determine if the device can differentiate the diseased states, refine signal processing~     algorithms to create reliable outcomes using this device in MS patients, and determine if~     these outcomes are strongly associated with patients and physicians reported ambulatory and~     dexterity metrics. The investigators hypothesize that this digital technology may be~     introduced in the standard neurological exam technique in a non-disruptive manner and more~     accurately and potentially remotely detect both physician-reported and patient-reported~     disability.~      In the scope of this study, the investigators will also develop signal processing methodology~     to comprehensively track ambulation features.~   "
15108|NCT03369158|"~     Randomized clinical study in order to evaluate the accuracy of pedicle screw positioning~     during spine surgery performed with MySpine patient match positioning guide or Free hand~     technique.~   "
15122|NCT03368963|"~     This phase I/II trial studies the best dose and how well trifluridine/tipiracil hydrochloride~     combination agent TAS-102 (TAS-102) and nanoliposomal irinotecan work in treating patients~     with gastrointestinal cancers that have spread to other places in the body or cannot be~     removed by surgery. Drugs used in the chemotherapy, such as trifluridine/tipiracil~     hydrochloride combination agent TAS-102 and nanoliposomal irinotecan, work in different ways~     to stop the growth of tumor cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading.~   "
15109|NCT03369145|"~     The present study will investigate the effect of high-fat overfeeding on a group of~     liver-secreted proteins linked to worsened blood sugar control, as well as proteins involved~     in appetite control. Participants will consume both a high-fat diet, consisting of 50% extra~     calories above their daily required intake, and a control diet, consisting of their normal~     'habitual' diet, with each diet lasting seven days. The diets will be undertaken in a~     randomised order, with a period of three weeks separating the two diets. Blood samples will~     be taken before and after each diet to measure blood sugar control. Further blood samples~     will also be taken 24 hours and 72 hours into each diet to see how levels of the liver and~     appetite-regulating proteins change over the course of the seven days.~      It is expected that blood sugar control will be worsened by the high-fat diet and this will~     be accompanied by increases in levels of the liver-secreted proteins and an impaired release~     of the appetite-regulating proteins into the blood.~   "
15110|NCT03369132|"~     Prospective, randomized, double-blind, placebo-controlled, multicentre clinical trial to~     assess the efficacy and tolerability of natural seawater based throat spray among adult~     patients with acute sore throat.~   "
15111|NCT03369119|"~     Leukotriene receptor antagonists (LTRAs) are well established in the management of outpatient~     asthma. Montelukast is a potent, specific, orally active, cysteinyl leukotriene receptor~     antagonist with a rapid onset of action.However, there is very little information as to their~     role in acute asthma exacerbations.~      The purpose of this study is to determine if adding oral montelukast to the maximal standard~     treatment in children hospitalized for acute asthma has any additive benefit.~   "
15112|NCT03369106|"~     This study will identify a combination of disease severity markers (genetic, immunology,~     epigenetic, imaging) associated with disease severity and progression in a cohort of patients~     with multiple sclerosis.~   "
15113|NCT03369093|"~     Burden: Pneumonia remains the leading infectious cause of death accounting 920,000 children~     under five around the world. This means a loss over 2,500 child lives every day, or over 100~     every hour. Since 2000, the number of child deaths caused by pneumonia has decreased by 47~     per cent. The tremendous progress made is due in part to the rapid roll-out of vaccines,~     better nutrition and improved care-seeking and treatment for symptoms. However, pneumonia~     hasn't declined as quickly as other diseases such as malaria (58%), HIV/AIDS (61%) and~     measles (85%).~      Knowledge gap: The Lancet Series on Childhood Pneumonia and Diarrhea has reported that case~     management is one of the three most effective interventions to reduce pneumonia deaths in~     children. It is also noted that cost effectiveness of these interventions in national health~     system needs urgent assessment. It was suggested to find out means to reduce hospital stay~     without compromising the quality of care.~      Relevance: The main purpose of our study is to compare the efficacy of two doses of~     parenteral Amoxicillin plus single dose Gentamicin compared to four doses of parenteral~     Ampicillin plus single dose Gentamicin. After 72 hours of treatment injectable Amoxicillin or~     injection Ampicillin will be switched to or replaced by oral Amoxicillin and will be~     discharged with an advice to attend to Ambulatory Care Unit (ACU) to receive once daily dose~     of injection Gentamicin for total 5 days. It is anticipated that this modified therapy will~     reduce hospitalization stay of children with severe pneumonia and would therefore be~     relevance in countries with resource poor setting. By reducing hospitalization period, this~     therapy has potentials to reduce hospital acquired infection.~      Hypothesis (if any): Rate of treatment failure with two doses of injectable Amoxicillin plus~     single dose Gentamicin will be not more than that of four doses of injectable Ampicillin plus~     single dose Gentamicin in the management of children between 2 months to 59 months~     hospitalized for WHO classified severe pneumonia.~   "
15114|NCT03369080|"~     This study is a prospective national survey of body mass index, and includes all patients~     with a new spinal cord injury hospitalized at Clinic for Spinal Cord Injuries, Rigshospitalet~     and Spinal Cord Injury Center of Western Denmark during a period of 9 months. Informed~     consent is retrieved from all participants.~   "
15115|NCT03369054|"~     Transgender and gender diverse (TGD) individuals are at an increased risk for mental health~     concerns, including anxiety, trauma-based distress, depression, self-harm, and suicidality.~     Quantitative and qualitative studies have shown that support appears to mediate mental health~     concerns, but to date, there have been zero psychotherapy studies focusing on transgender and~     gender diverse patients. The NIH has noted that TGD patients are considered to be a health~     disparities population, indicating that there is considerable research to support prevention~     and reduction in mental health disparities for this population.~      There are two aims to the current study—Aim 1: investigate the feasibility of conducting a~     psychotherapy randomized controlled trial for transgender and gender diverse populations, and~     Aim 2: longitudinally investigate the impact of minority stress interventions on well-being~     for transgender and gender diverse patients.~      First, it is hypothesized that this study will demonstrate feasibility regarding recruitment~     of transgender and gender diverse patients and that patients from both groups will report~     treatment acceptability. We also hypothesize that patients will report more acceptability for~     treatments that are focused on minority stress interventions. It is hypothesized that~     individuals in both the Minority Stress Treatment (MST) group and Treatment as Usual (TAU)~     group will both show improvements in well-being, but that the MST group will demonstrate~     larger effects in outcomes.~      No known published studies have focused on minority stress psychotherapy interventions for~     transgender and gender diverse populations. The findings from the proposed study will provide~     a multitude of information regarding longitudinal psychotherapy interventions focusing on~     minority stress that will inform future treatment manuals and larger, multi-site studies.~   "
15116|NCT03369041|"~     In order to extract the profiles of patients receiving DEBIRI treatment at best, the~     investigators proposed the establishment of a national prospective cohort to collect~     information on the greatest number of patients treated with DEBIRI. This cohort will allow a~     better understanding of the effectiveness, tolerance, feasibility and differences of~     practices at national level for this approach. These data will assist in the development of~     clinical trials in situations that appear to be most promising in clinical practice.~   "
15117|NCT03369028|"~     Around ten percent of newborn infants require positive pressure ventilation (PPV) in the~     delivery room. This is most commonly delivered using a round or anatomically shaped face mask~     attached to a T-piece device, self-inflating bag or flow-inflating bag. Face mask ventilation~     is a challenging technique and difficult to ensure that an appropriate tidal volume is~     delivered because large and variable leaks occur between the mask and face.~      It is recommended by International Guidelines to start with mask ventilation by placing a~     fitting face mask on the babies face.~      A fitting face mask covers the mouth and nose. A non-fitting overlaps the eyes and the chin,~     which causes a airleak. Studies report variable leak, sometimes more than 50% of inspiratory~     volume, during PPV in preterm infants in the delivery room. The presence of a large leak may~     lead to ineffective ventilation and an unsuccessful resuscitation.~      A study performed in preterm infants showed that most masks available are too big for the~     majority of those infants.~      The investigators hypothesis is that the commonly available face masks for term infants are~     similarly too big for some term and late preterm infants (>=34 weeks gestation).~   "
15118|NCT03369015|"~     The purpose of this study is to establish the dose-response curve for therapeutic doses of~     d-amphetamine on tasks of motivation and reward learning in the same participants and to use~     d-amphetamine as a dopaminergic probe to test newer theories about the role of dopamine in~     reward-related decision-making.~   "
15119|NCT03369002|"~     This Phase 1 open label study is being conducted to directly characterize the pharmacokinetic~     (PK) profiles of seladelpar following administration of a single oral dose in subjects with~     varying degrees of hepatic impairment (HI) compared to healthy matched control subjects with~     normal hepatic function.~   "
15127|NCT03368898|"~     Heavy menstrual bleeding or menorrhagia, is a common problem on women's lives and can burden~     both patients and health care systems. HMB is defined as cyclic heavy vaginal bleeding.~     Hormonal treatment of heavy menstrual bleeding (HMB) is also endorsed as the first line~     treatment in several international guidelines. The effects of these therapies on bleeding~     related quality of life are not well known. The aim of the present study is compare the~     effect of Estradiol Valerate/Dienogest (E2V/DNG), Levonorgestrel-Intrauterine Device~     (LNG-IUD) and oral micronized progesterone treatment on bleeding pattern, cycle control,~     menopausal symptoms and patient satisfaction of women with HMB.~   "
15128|NCT03368885|"~     The study has two arms; both experimental and control areas will receive standard~     interventions given under polio eradication program of PCI. Participants in the experimental~     arm receive additional interventions on nutrition (improve diet diversity in pregnant women~     and children of 6-23 months) for exact 12 months. The study includes awareness generation~     (regarding nutrition) through community mobilization, counseling and capacity building of~     community mobilization.~   "
15129|NCT03368872|"~     The primary objective of this trial is to evaluate the effect of oral administration of an~     Astaxanthin formulation compared to placebo after one month alone and after an additional 3~     months of exercise training on mitochondrial and skeletal muscle function in elderly subjects~     with evidence of mitochondrial dysfunction/sarcopenia.~   "
15130|NCT03368859|"~     A study to evaluate the efficacy and tolerability of ABT-165 plus FOLFIRI compared to~     bevacizumab plus FOLFIRI in participants with previously treated metastatic adenocarcinoma of~     the colon or rectum.~   "
15131|NCT03368846|"~     This is a single-centre, open-label, non-randomised, single oral dose study in healthy male~     subjects. It is planned to enrol a single cohort of 6 healthy male subjects to ensure data in~     4 evaluable subjects.~      Each subject will receive a single administration of 120 mg [14C] varlitinib oral suspension~     containing not more than (NMT) 2.9 MBq (79 µCi), in the fed state.~   "
15132|NCT03368833|"~     Caudal epidural blockade is frequently used as an adjunct to general anesthesia in children~     for perioperative analgesia. Intravascular injection of local anesthetic is a known~     complication that can adversely affect the neurological and cardiovascular systems. This~     study will look at the delayed effects of a caudal epidural block on the electrical activity~     of the patient's myocardium by trying to characterize the incidence of ECG changes within 60~     minutes after the caudal dose is given.~   "
15133|NCT03368820|"~     Therapeutic algorithms for lung cancer are mainly based on randomised controlled trials which~     excluded patients with severe co-morbidities. Smoking, the main risk factor for lung cancer,~     is associated with cardiovascular events that may impact on the therapeutic decision.~      The aim of this registry is to determine if and how cardiovascular co-morbidities impact on~     the physicians' decision for anticancer treatment in lung cancer patients by comparing it to~     the European Lung Cancer Working Party (ELCWP) guidelines~   "
15134|NCT03368807|"~     The main purpose of this study is to estimate missed bolus insulin doses in diabetics. This~     is a 12-week, single-arm, outpatient, exploratory study with two study periods in Type 1 or~     Type 2 diabetics, with an investigational reusable injection pen, insulin, and a Continuous~     Glucose Monitoring (CGM) device.~   "
15135|NCT03368794|"~     The study tests a structured referral process for opioid overdose survivors, from~     pre-hospital emergency care to long-term treatment of the individual's substance use-related~     disorder.~   "
15136|NCT03368781|"~     A prospective, single-arm, multi-center, multi-national, non-randomized, post-market study~     designed to provide clinical data regarding the use of the AcQMap High Resolution Imaging and~     Mapping System during an atrial fibrillation retreatment ablation procedure.~   "
15137|NCT03368768|"~     Antimicrobial-resistant bacterial infection is an important cause of death in Thailand and in~     other countries worldwide. Increasing use of antibiotics in both animals and humans is one of~     the main drive that increase the incidence of antimicrobial resistant bacteria in human,~     animals and environment.~      National Action Plan for Combating Antibiotic-resistant Bacteria aimed to have general~     population taking antibiotics less than 20% when they have common cold or diarrheal symptoms.~     However, there is little accurate information about behaviors of Thai people. Most studies~     were conducted in hospitals, clinics or pharmacy. Therefore, it did not include behaviors of~     those who had symptoms but did not present at hospitals, clinics or pharmacy.~      In this study, the investigators aim to use questionnaire to Thai adult population to ask for~     the the amount of antibiotic used and the periods they had symptoms of common cold or~     diarrhea over one year period of year 2017. The main aim is to estimate the total antibiotic~     usage per human population, and plan for the study in the future.~   "
15138|NCT03368755|"~     The study hypothesis is that intrauterine growth restriction (IUGR) may have long-term~     effects on respiratory muscle (RM) function, thus leading to reduced exercise capacity later~     in life. The objective is to investigate the above hypothesis by comparing RM function and~     cardiopulmonary exercise testing (CPET) parameters between school-aged children exposed to~     IUGR and healthy controls.~   "
15139|NCT03368742|"~     This is a randomized, controlled, open-label, single-ascending dose study to evaluate the~     safety, tolerability and efficacy of SGT-001 in adolescents and children with Duchenne~     muscular dystrophy (DMD). Eligible patients will be randomized to an active treatment group~     or an untreated control group. Patients in the active treatment group will receive a single~     intravenous (IV) infusion of SGT-001 and will be followed for approximately 2 years. Patients~     in the untreated control group who continue to meet treatment criteria will receive SGT-001~     after 1 year on study.~   "
15140|NCT03368729|"~     The human epidermal growth factor receptor 2 (HER2) regulates cell growth and survival.~     Approximately 15-20% of all breast cancers are HER2-positive, which are an aggressive and~     fast-growing subtype of breast cancer. This study will evaluate a new treatment using a~     potent Poly polymerase (PARP) inhibitor known as Niraparib. Niraparib will be combined with~     trastuzumab, a HER2-targeted agent, to evaluate the safety and tolerability in patients with~     metastatic HER2 positive breast cancer. It is anticipated that the combination of drugs will~     improve survival and have few side effects.~   "
15144|NCT03368677|"~     To evaluate the effect of teriflunomide treatment on microglial activation in late stage~     multiple sclerosis.~   "
15145|NCT03368664|"~     Primary Objective:~      To evaluate the efficacy, safety, and tolerability of alemtuzumab (IV) in pediatric patients~     from 10 to <18 years of age with Relapsing Remitting Multiple Sclerosis (RRMS) who have~     disease activity on prior Disease Modifying Therapy (DMT).~      Secondary Objective:~      To assess the pharmacokinetics (PK), pharmacodynamics (PD), anti-drug antibody (ADA)~     formation, and potential effects of alemtuzumab on other multiple sclerosis (MS) disease~     characteristics such as cognition and quality of life (QoL).~   "
15146|NCT03368651|"~     To compare the impact on survival of neo-adjuvant TAI for patients with HCC and PVTT who~     underwent hepatectomy.~   "
15147|NCT03368638|"~     Aging of the back is common in the older people and can result in difficulties standing and~     walking. Conservative treatment is recommended before considering surgery. Some recommended~     exercises involve the use of expensive equipment. The present study plans to evaluate if~     specifically moving the nerves in the legs/back and improving flexibility of the hip and back~     can benefit patients. These exercises require no equipment, are simple to perform, and can~     provide patients a way to continue to perform these exercises at home. The purposes of this~     study are to (1) observe the benefit of a treatment program involving moving the nerves of~     the leg/back, stretching the legs and low back in patients with low back pain and~     difficulties walking; and (2) determine if benefits received remain at a 3-month follow-up.~   "
15148|NCT03368625|"~     This study will be a non-randomized phase II trial for patients with one to six brain~     metastases, at least one of which is appropriate for surgical resection. Upon registration,~     patients will be assigned to receive neo-adjuvant stereotactic radiosurgery (NASRS).~   "
15149|NCT03368612|"~     The study aims at evaluating the AirGoTM system's performance, as compared to standard~     pulmonary function tests.~   "
15150|NCT03368599|"~     Double lumen tube (DLT) needs to be intubated to isolate ventilations of left and right lungs~     for thoracic surgery. Post-operative sore throat and hoarseness are more frequent with DLT~     intubation than with single one. Which is may because DLT is relatively thicker, harder,~     sideway curved and therefore more likely to damage the vocal cord or trachea during~     intubation, and advanced deeper to the carina and main bronchus level. In the conventional~     method of intubation, DLT is rotated 90 degrees and advanced blindly to the main bronchus~     level after DLT is intubated through vocal cord using the direct laryngoscopy. After the~     blind advancement, the sufficient tube position needs to be gained and confirmed with the~     fiberoptic bronchoscope. In the bronchoscope guide method, after DLT is intubated through~     vocal cord using the direct laryngoscopy, the pathway into the targeted main bronchus is~     secured using the fiberoptic bronchoscope which is passed through a bronchial lumen of DLT.~     And then DLT can be advanced through the guide of the bronchoscope. In this study, we intend~     to compare post-operative sore throat, hoarseness and airway injury between the two methods.~     We hypothesize that the bronchoscope guide method can reduce the post-operative complications~     and airway injury because surrounding tissues of the airway can be less irritated by DLT~     intubation in the guide method than in a conventional.~      For a constant guide effect, we use fiberoptic bronchoscopes with same outer diameter (4.1~     mm) which can pass through a bronchial lumen of 37 and 39 Fr Lt. DLT and cannot pass through~     35 Fr or smaller Lt. DLTs.~      <Lt. DLT size selection>~        -  male: ≥160 cm, 39 French; < 160 cm, 37 French~        -  female: ≥160 cm, 37 French; < 160 cm, contraindication~   "
15151|NCT03368586|"~     The aim of this study was to assess accuracy, satisfaction and usability of the FGM among~     children and adolescents with T1DM. The primary outcome was to assess the accuracy of the FGM~     system. Secondary outcomes included satisfaction and usability of the device as well as~     assessment of sensor-related issues.~   "
15152|NCT03368573|"~     Attention Deficit/Hyperactivity Disorder (ADHD) is a condition that affects 3-5% of young~     people under 18-years-old.~      Young people with ADHD have difficulties with attention, impulsivity and hyperactivity that~     make it harder for them to learn, form relationships and prepare for adulthood. Clinical~     guidelines state that young people taking medication for ADHD should be closely monitored and~     have their medication reviewed regularly to ensure they receive the correct dose to improve~     their symptoms. However, many young people aren't monitored as closely as guidelines~     recommend. This can lead to lack of improvement or worsening of symptoms meaning that~     children may not experience the benefits of medication as quickly as they should. At the~     moment, assessing whether or not medication is working relies on the opinions of teachers and~     parents, collected through questionnaires. The difficulties of this are: differences of~     opinion between people, lack of information provided by them, and not returning the~     questionnaires. A test performed on a computer (QbTest) provides doctors with a report of the~     young person's symptoms and can therefore show whether medication is working. This may help~     doctors reach accurate decisions about medication dose more quickly, reducing the need for~     questionnaires. The study team met with families and young people with ADHD and medical~     experts and developed a procedure for using QbTest to measure medication effects. The study~     team will measure how well this procedure works in the real world by asking a group of young~     people to complete the test when they first start taking medication and at their follow-up~     appointments. The study team will ask doctors and families/young people for their opinions on~     the procedure.~      The study team shall share our findings with other researchers and with the public by~     attending local support groups and providing summaries of the study results. The findings~     will be used to prepare for a future study.~   "
15153|NCT03368560|"~     Late-life depression affects 2-8% of seniors and causes high rates of caregiver distress and~     risk of suicide. To exacerbate the problem, antidepressants, the cornerstone of therapy, are~     resistant in 55-80% of this population. Hence, this group of patients is labeled as having~     treatment-resistant late-life depression (TR-LLD).~      Non-pharmacological interventions like meditation could offer significant benefits as~     augmentation strategies to improve response rate of antidepressants in TR-LLD. One such~     breath-based meditation intervention called Sudarshan Kriya Yoga is of interest based on~     highly significant preliminary data in adult patients with treatment-resistant depression,~     its scalability and relatively low cost to learn this lifelong skill.~      Thirty patients diagnosed with TR-LLD will learn this intervention over 5 consecutive days by~     a certified para-professional trainer. This will be followed by 3 weekly 90 min follow-up~     sessions and then bimonthly sessions for 8 more weeks. SKY consists of a series of breathing~     techniques, including Sudarshan Kriya (SK), a sequential rhythm-specific breathing exercise.~     Participants will be asked to practice this technique for 25-30 minutes daily over the next~     11 weeks. The investigators will collect clinical as well as feasibility outcome measures.~     The investigators will also explore if it is feasible to assess the antioxidant Glutathione~     (GSH) in the brain using a sophisticated magnetic resonance spectroscopy. The investigators~     suspect that GSH levels are reduced in TR-LLD and they will improve with SKY.~   "
15154|NCT03368547|"~     This clinical trial studies how well 68Ga-PSMA-11 positron emission tomography (PET)/computed~     tomography (CT) works in imaging patients with intermediate or high risk prostate cancer~     before surgery. Diagnostic procedures, such as PET/CT scans, may help find and diagnose~     prostate cancer and find out how far the disease has spread.~   "
15156|NCT03368521|"~     This study aims to investigate if a low back pain screening tool is helpful for the~     caregivers to direct the rehabilitation in a more efficient way, at an earlier stage. Primary~     Health care centers in the municipality of Halmstad, Sweden will be enrolled to participate~     in the study as either Control or intervention. The primary Health care centers who are~     enrolled taking part in the intervention, will use the provided screening tool when taking~     care of patients seeking care for low back pain. Scorings from the screening tool will~     label the patients as one of Three pre-defined risk levels. The caregiver will then use the~     provided risk level when deciding how to proceed the rehabilitation. Based on the risk level~     identified, the patient is directed to one of three levels of treatments - including simple~     advice; physiotherapy; or multimodal rehabilitation. The screening tool is used as a~     complement to the examination, allowing the physiotherapist /GP to decide how to proceed with~     rehabilitation using the back screening tool, together with Clinical examinations. The~     Control Group consists of patients recruited when seeking care for back pain at a Primary~     Health Care service who has been randomly selected as Control. The care givers at the~     Control primary Health care will conduct as usual, not using the back pain screening tool in~     their Clinical examinations.~   "
15157|NCT03368508|"~     Simulation is becoming the main trend of training allied health students, several~     experimental studies have been conducted to evaluate the effectiveness of various simulating~     interventions including virtual reality software and real-patient simulation (Ladyshewsky,~     Baker, Jones, & Nelson, 2000; Mori, Carnahan, & Herold, 2015; Schlickum, Hedman, Enochsson,~     Kjellin, & Felländer-Tsai, 2009). Although the outcomes of the training approaches have shown~     to be positive, the costs of creating the simulations are considerably high(Blackstock &~     Jull, 2007; Watson et al., 2012) and the evidence to support the effectiveness of simulated~     interventions in healthcare training is yet to be sufficient (Mori et al., 2015).~      As a kind of virtual reality technology, 360-degree videos allow free control of a~     first-person panoramic view by the users (Qian, Ji, Han, & Gopalakrishnan, 2016). Together~     with a VR goggle, the videos can provide a stimulating environment for the users for~     entertainment or learning (Hughes, Stapleton, Hughes, & Smith, 2005). In addition, with the~     development of the 360-degree camera, the 360-degree videos can be produced in an economical~     way.~      Therefore, it is proposed the use 360-degree videos could be possibly a cost-effective way to~     be a form of simulation for training physiotherapy students.~   "
15158|NCT03368495|"~     This study evaluates seroconversion against measles, mumps, rubella and yellow fever~     following vaccination. One-third of children will receive both yellow fever and measles,~     mumps, and rubella (MMR) vaccines on the same day; one- third of children will receive MMR~     vaccine at enrollment followed by yellow fever vaccine 4 weeks later; one-third of children~     will receive yellow fever vaccine at enrollment followed by MMR vaccine 4 weeks later.~   "
15159|NCT03368482|"~     Scientific evidence regarding the effects of Brain Gym®, on people with cognitive impairment~     is scarce. This study aimed at comparing the effects of a program based on Brain Gym®~     exercises against a fitness exercise program on the cognitive function, functional~     independence, physical fitness and quality of life in institutionalized older adults with~     cognitive impairment.~   "
15160|NCT03368469|"~     The proposed study seeks to obtain preliminary signal of the tolerability and efficacy of~     transcranial direct current stimulation (tDCS) for depressive symptoms in a sample of~     adolescents with depression and epilepsy. Additionally, effects of tDCS will be assessed via~     electroencephalographic, cognitive, and psychosocial measures.~   "
15161|NCT03368456|"~     The study evaluates the preliminary efficacy of an innovative mobile-health (mHealth)~     intervention (hereon referred to as S4E) to improve human immunodeficiency virus and sexually~     transmitted infection testing and reduce HIV/STI risk behaviors in a clinic sample (n=100) of~     at-risk youth ages 14-21 living in Southeast Michigan. A Stage I randomized control trial~     will be conducted to examine the preliminary efficacy of S4E, relative to Usual Care (UC),~     over a period of six months.~   "
15162|NCT03368443|"~     Context-dependent learning (CDL) is a phenomenon that an individual demonstrates superior~     motor performance in the environmental context in which a task was originally learned and~     practiced, while the performance may decrease if carried out in a novel context. It has often~     been observed that after individuals with Parkinson's disease (PD) learned how to walk in a~     clinical setting, they appear to have difficulty generalizing the learned walking ability~     back to their home or community. To date, no effective intervention approaches have been~     designed to resolve this CDL for people with PD. One approach that could potentially reduce~     CDL is to practice a motor task in multiple contexts. Learning a task in multiple contexts~     would make the participants less likely to rely on the inconsistent ambient contextual~     information, and could facilitate the generation of stronger motor program and schema. No~     studies to date have investigated the effects of multiple practice contexts on reducing CDL~     in people with PD. It is also not clear the characteristics of the participants who would~     benefit from this type of intervention.~      This study aims to investigate the effects of gait training in multiple practice contexts on~     CDL in individuals with PD. Additionally, this study aims to identify the characteristics of~     the participants who benefit from the intervention.~      Eighty-five participants diagnosed with idiopathic PD will be recruited and randomized into 3~     groups: Single-room, Two-room, and Three-room groups. The participants will receive 45~     minutes of treadmill training and 15 minutes of over-ground gait training for 12 sessions.~     Throughout the training sessions, the Single-room group will practice walking in the same~     room, while the Two-room group and Three-room group will receive gait training in 2 and 3~     distinct rooms, respectively. All participants will be assessed by a blinded evaluator~     before, immediately after, and 4 weeks after the intervention. The participants will undergo~     a series of cognitive, motor behavior, and neurophysiological examinations.~      Group × time repeated measures analysis of variance (ANOVA) and the partial eta square (η2)~     will be calculated to determine the intervention effects on the outcome measures. Multiple~     linear regression analyses will be performed to determine the demographic, cognitive and~     motor behavior, and neurophysiological characteristics of participants who benefit from the~     proposed interventions.~   "
15163|NCT03368430|"~     Background:~      Melatonin is an endogenous indoleamine synthesized mainly by pineal gland and showed~     anti-inflammatory and antioxidant properties. Moreover, melatonin promotes osteoblastic~     differentiation and suppresses osteoclastic formation. This randomized clinical trial (RCT)~     was aimed to assess the additive effect of melatonin supplementation in generalized chronic~     periodontitis (gCP) patients with insomnia who received scaling and root planing (SRP).~      Methods:~      Seventy four gCP patients with primary insomnia participated in this 6-month RCT and randomly~     distributed between two groups. Melatonin group (MTN+SRP group, n=38) included patients who~     were subjected to SRP with a 2- month regimen of 10 mg oral melatonin supplementation capsule~     once daily at bed-time. In the control group (Placebo+SRP group, n=36), SRP was performed for~     participants provided with matching placebo capsules. The primary treatment outcome included~     the clinical attachment gain (CAG) after 3 and 6 months of therapy, whereas, the changes in~     pocket depth ,bleeding on probing (BOP%) and salivary tumor-necrosis factor-α (TNF-α) levels~     represented the secondary outcomes.~   "
15164|NCT03368417|"~     Hypertension is a major risk factor for cardiovascular morbidity and mortality. Despite the~     risks of hypertension and availability of effective treatment, a substantial number of~     patients have uncontrolled Blood Pressure (BP). Systematic reviews have shown that Home Blood~     Pressure Monitoring (HBPM) produces modest improvements in BP control and that HBPM yields~     greater benefits when combined with other interventions such as remote titration change or~     adherence-enhancing strategies.~      The investigators propose a Wireless HBPM System comprising of a Wireless Home Blood Pressure~     Monitor and a Study Application that aims to: provide text messaging on BP advice and~     reminders on BP management based on BP readings; promote adherence to BP monitoring and~     adherence to medication; flag patients for counselling on medication adherence and remote~     titration (by doctor) during in-between visits; cut the response time in case of emergency;~     and skip polyclinic visits for well-managed patients.~      An additional arm will include the the addition of modest financial incentives for~     participants when they monitor their BP. This arm is subdivided into two sub-arms (Instant~     Reward and Health Capital) where patients are eligible to receive the same incentive amounts~     but framed differently.~      This study is novel in its comprehensive approach to patient disease self-management and~     remote provision of medical care, potentially reducing the burden on the health system and~     improving patient health outcomes.~   "
15165|NCT03368404|"~     This is a multicenter, randomized, parallel group, investigator-masked, non-inferiority~     study. Approximately 84 subjects will be randomized in a 1:1 ratio.The primary objectives of~     this investigation are to show that the performance of CBL-102 Eye Drops is non-inferior to~     that of Vismed® Multi eye drops in subjects with moderate to severe keratoconjunctivitis~     sicca after 28 days, and to assess the safety of CBL-102 Eye Drops during a 90-day period~     with treatment administered 3 to 6 times per day. The primary performance endpoint for this~     study is the mean change from baseline (CFB) in the study eye at Visit 4 (Day 28 ± 3 days) in~     ocular surface fluorescein staining score.~   "
15166|NCT03368391|"~     Anesthetics with vasoconstrictors decrease pulpal blood flow but the impact of intranasal~     local anesthetics on blood flow is unknown. This blinded, randomized crossover clinical trial~     will compare the effects of different local anesthetics on anterior teeth in healthy~     volunteers. On separate study visits patients will receive either traditional injections or~     intranasal administration of the following solutions: 2% lidocaine with 1:100,000 epi, 3%~     mepivacaine, tetracaine HCl and oxymetazoline HCl, or saline. The following variables will be~     assessed: pulpal blood flow, pulpal sensibility, pain on administration, and adverse~     outcomes.~   "
15167|NCT03368378|"~     The aim of the study is to evaluate the impact of early deep venous complex ligation (eDVCL)~     in patients affected by clinically localized prostate cancer (PCa) undergoing robot-assisted~     radical prostatectomy with or without pelvic lymph node dissection. Overall, 312 patients~     will be randomized to the standard technique vs. eDVCL. The primary endpoint is represented~     by early urinary continence recovery. The secondary endpoints are perioperative outcomes,~     erectile function recovery and positive surgical margins.~   "
15168|NCT03368365|"~     Acute cellular and/or humoral rejection and early graft infections after pulmonary transplant~     (<2.5 years) are common and can lead to chronic dysfunction of the transplanted organ or~     Chronic Lung Allograft Dysfunction, CLAD. These complications increase the number of~     unplanned and life-threatening hospitalizations. Regular multi-weekly monitoring of~     respiratory function is necessary to detect these complications early and to make their~     management more effective and less costly. Monitoring by micro spirometers with forced~     expirations at home proved difficult to perform (patient and effort dependent), often poorly~     coordinated (transmission of data to practitioners) and not sensitive in the prediction of~     post-transplant complications. Aqsitania has developed an innovative analysis of resting~     respiratory signals. This innovative analysis is called Anharmonic Morphological Analysis of~     Respiratory Signals (AMARS). This automated analysis is based on a measurement of the~     respiration collected by a spirometry device communicating and allowing a remote home~     monitoring (Ventilotel®). We hypothesize that this Anharmonic Morphological Analysis of~     Respiratory Signals at rest could predict unplanned hospitalizations and allow for more~     reliable monitoring of pulmonary transplant patients. Inclusion visit: Explanation of the~     study and collection of consent, measurement of resting breath and explanation on the mode of~     use of the measuring device at home, clinical examination, respiratory functional~     exploration. Follow-up at home for 12 months with a resting breath measurement for 2 to 3~     min, in the morning on waking and in the evening before bed, 2 days / week with automatic~     sending of data on the Aqsitania server. The first month, a visit at home can be made if the~     subject feels the need. At each measurement, Aqsitania transmits the data in the e-CRF, a~     report that gives the anonymised values of the markers and the current personal respiratory~     profile. In order to avoid motivational bias, patients will have instructions to use the~     device but no coaching call will be made during the study. Patients will have their monthly~     or quarterly follow-up visits, including clinical examination, respiratory functional~     exploration and an analysis of adverse events. No additional search-specific visits will be~     carried out.~   "
15169|NCT03368352|"~     Low oxygen at altitude causes pauses in breathing during sleep, called central sleep apnea.~     Central sleep apnea causes repeated awakenings and poor sleep. Low oxygen itself and the~     induced oxidative stress can damage mental function which is likely worsened by poor sleep.~     Reduced mental function due to low oxygen can pose a serious danger to mountain climbers.~     However there is also mounting evidence that even in populations of people that live at high~     altitudes and are considered adapted, low oxygen contributes to reductions in learning and~     memory. Therefore there is a serious need for treatments which may improve sleep, control of~     breathing and mental function during low oxygen. Melatonin is a hormone produced in the brain~     during the night which regulates sleep patterns with strong antioxidant and anti-inflammatory~     properties. A study previously reported that melatonin taken 90 mins before bed at 4,300 m~     (14,200 ft) induced sleep earlier, reduced awakenings and improved mental performance the~     following day. However how melatonin caused these effects was not determined. Therefore this~     study aims to determine how melatonin effects control of breathing, sleep and mental~     performance during exposure to low oxygen.~   "
15170|NCT03368339|"~     To evaluate the efficacy and safety of PR013 topical ophthalmic drops (0.045% and 0.06%)~     compared to vehicle for the treatment of the signs and symptoms of allergic conjunctivitis~     using a modified Conjunctival Allergen Challenge Model (Ora-CAC®).~   "
15171|NCT03368326|"~     Brain injured patients are at high risk of pain due to the illness itself and a variety of~     nociceptive procedures in intensive care unit. Since the disorder of consciousness, speech,~     and movement, it is usually difficult for them to self-report the presence of pain reliably.~     The Critical-Care Pain observation Tool (CPOT) has been recommended for clinical use in the~     critically ill patients when self-report pain is unavailable. Besides, it seems that the~     bispectral index (BIS), a quantified electroencephalogram instrument, can be used for pain~     assessment along with the CPOT tool in some nonverbal critical ill patients (e.g., intubated~     and deep sedation). However, the validity and reliability of CPOT and BIS for pain assessment~     in brain injured patients are still uncertain so far. So the aim of this research is to~     investigate the value of CPOT and BIS for pain evaluation in this specific patient group.~   "
15172|NCT03368313|"~     The objective of the study is to conduct a Bayesian randomized trial comparing non-elastic~     compression garments applied with high pressure (Circaid group) with no compression (control~     group) in reducing signs and symptoms in the acute stage of DVT and subsequent postthrombotic~     syndrome. With a hypothesis that the Circaid group will present a quicker and more marked~     reduction of pain and leg swelling in the acute stage of DVT, as well as a 20% decrease in~     the frequency of postthrombotic syndrome within six months from the time of diagnosis of the~     acute deep vein thrombosis episode.~   "
15173|NCT03368300|"~     The primary aim of this study is to estimate the frequency and to characterize clinically~     atypical parkinsonism in the French West Indies and Guyana.~   "
15174|NCT03368287|"~     This study aims to estimated the change of the steps of daily life of osteoarthritis patients~     before and in 6 weeks, 3 months, 6 months, 1 year after the total knee arthroplasty (TKA)~     through a kind of activity tracker: Fitbit ONE.~   "
15175|NCT03368274|"~     30 untreated IgG4 related disease (IgG4-RD) patients with mild symptom are enrolled in this~     study, and will be treated with one dose of diprospan,then take Iguratimod 25mg, Bid orally.~     Patient's peripheral blood will be collected at baseline, 12 weeks and 24 weeks of follow up.~     The clinical efficacy will be evaluated by the IgG4-RD responder index, serum immunoglobulin,~     IgG4 and IgE, cytokines, and peripheral blood T cell and B cell sub-populations will be~     measured at baseline and follow up.~   "
15176|NCT03368261|"~     pulmonary arterial hypertension (PAH) has been reported with a prevalence of approximately~     30% in adult sickle cell disease (SCD) patients, with an increased mortality in SCD patients~     with PAH, compared with those without PAH. The identification of several hemolysis biomarkers~     such as lactate dehydrogenase, bilirubin, reticulocytes or hemoglobin level, has clearly~     documented a link between hemolysis and PAH. However, other physiopathological mechanisms may~     be involved to explain PAH in these patients, such as pulmonary thromboembolism, pulmonary~     fibrosis or left heart diastolic and / or systolic dysfunction.~      The investigators suggest studying HTAP in patient's presenting the most frequent both~     drepanocytic syndromes, SS and SC and homogeneous in their medical coverage and the~     association between HTAP risk and specific SCD complications.~   "
15177|NCT03368248|"~     In neonatal resuscitation, the majority of deaths currently occur after a Life Limitation or~     Discontinuance (LAT) procedure. In the 1990s, the approach was different, as Marina CUTTINI~     put it in a European study that highlighted some French peculiarities: doctors and nurses~     found it legitimate to have life stops in certain circumstances, and wanted to keep parents~     away from these decisions deemed guilt. Civil society has changed the thinking in recent~     years by the so-called Kouchner then LEONETTI laws. The palliative approach, which is defined~     as the search for a fair and reasonable balance, constantly reevaluated, between curative~     care and care of comfort and support, has become a constant concern in neonatal resuscitation~     services. However, we did not find a recent study that specifies in France the modalities of~     deaths in neonatology, especially their proportion after LAT. Also, shortly before the~     adoption of the CLAYES-LEONETTI law, the authors wished to make an inventory of the practices~     of all the neonatal intensive care units of Ile de France, one of the main centers of French~     fertility.~      The objectives of the study were to describe the organization of collegial meetings (CR), the~     decision-making process and implementation of LATs, with particular attention to stopping~     artificial nutrition and hydration, and sedation / analgesia. The place of the parents in~     these different processes (gathering their opinion, information on how to withdraw~     life-saving treatment, leading in the event of disagreement) was also studied. Finally, some~     questions about euthanasia were asked, in order to measure the evolution of ideas and~     practices more than 15 years after EURONIC and 10 years after the LEONETTI law.~   "
15178|NCT03368235|"~     This is a phase 2a study to be run in 2-3 countries in European Union involving 5-6 sites. It~     will enroll approximately 80 patients to ensure 40 randomized with active rheumatoid~     arthritis. The treatment period is 2 weeks and total study duration per patient is~     approximately 1 month. The study drugs are AZD9567 40 mg (an oral SGRM) and the comparator is~     prednisolone 20mg. The primary endpoint is DAS28 including evaluation of 28 joints and~     C-reactive protein. Safety parameters will also be evaluated and a biomarker program is~     included for future research.~   "
15179|NCT03368222|"~     This is a single centre non-randomised open label phase 1 trial of lung SBRT to part of a~     lung lesion in patients with advanced NSCLC in combination with pembrolizumab. This study~     will recruit up to 24 patients whose lung cancer has progressed beyond one line of palliative~     chemotherapy, and an EGFR or ALK inhibitor if an EGFR driver mutation or ALK gene~     rearrangement is present, respectively, and now requires further palliative systemic~     treatment.~   "
15180|NCT03368209|"~     This study collected spectral raman data from diabetic patients. Data was paired with~     validated capillary references as well as CGM/FGM readings. Data was used to develop models~     for glucose prediction.~   "
15181|NCT03368196|"~     HER2-positive cancer is a cancer that tests positive for a protein called human epidermal~     growth factor receptor 2 (HER2). HER2 promotes the growth of certain cancer cells. This study~     will test an experimental drug called DS-8201a that has not been approved by the health~     authorities yet.~      DS-8201a will be tested for safety in Chinese patients with certain types of stomach and~     breast cancer that test positive for HER2. It also will test how DS-8201a moves within the~     body (pharmacokinetics).~   "
15182|NCT03368183|"~     This study is of a clinical decision support tool for clinicians taking care of patients with~     severe acute kidney injury in the intensive care unit. Nephrologists will be given a~     standardized clinical assessment and management plan (SCAMP), which is a tool to assist~     clinicians in decision making on the need for renal replacement therapy (Mendu et al., CJASN~     2017). In alternating months, nephrologists will be given the SCAMP vs. another simplified~     form. The goal is to test whether patients whose clinicians are asked to fill out the SCAMP~     have improved outcomes compared to the control group. The investigators are also collecting~     information about provider adherence to the SCAMP and deviations from the SCAMP~     recommendations to understand clinical decision making related to renal replacement.~   "
15232|NCT03367533|"~     The proposed study will assess the combined effect of perampanel and ketamine on the~     anti-depressant response in individuals with treatment resistant depression. The purpose of~     this study is to test the hypothesis that stimulation of Alpha-Amino-3-Hydroxy-5-Methyl-4-~     Isoxazole Propionic Acid receptors (AMPAR) is critical to the anti-depressant response of~     ketamine.~   "
15183|NCT03368170|"~     IRL790 is an experimental small molecule compound with psychomotor stabilizing properties.~     The primary target is the dopamine D3 receptor, a target implicated in the generation of~     levodopa-induced dyskinesia, a side-effect frequently occurring with long-term levodopa~     treatment in patients with Parkinson's disease. In experimental animals IRL790 potently~     reduced levodopa-induced involuntary movement without impairing the antiparkinsonian effect~     of levodopa.~      The primary purpose of the trial is to investigate whether IRL790 given as adjunctive~     treatment can reduce levodopa induced dyskinesia in patients with Parkinson's disease. The~     trial will also help to establish the most optimal dosing of the compound.~   "
15184|NCT03368157|"~     The purpose of the study is to develop a detailed pregnancy registry of patients with~     Multiple Sclerosis in the New England states. Women with a diagnosis of MS that are either~     pregnant or actively planning to become pregnant are eligible to participate.~      The study will solely take place through phone interviews. One of the study coordinator at~     the Partners MS Center will contact the participant for an intake phone interview where~     general information about the individual, their pregnancy and their MS will be collected.~     Thereafter the coordinator will contact the participant every 3 months for 20 minutes follow~     up interviews. After birth, the coordinator will collect information on the growth and~     development of the participant's baby. Pediatric interviews will be conducted at 2, 4, 6, 9,~     12, 18, 24, 36 months. Information from the participant's neurologist and obstetrician, as~     well as information from the baby's pediatrician, will be made available to the study staff~     at regular intervals throughout the duration of the study.~      Through this study, the investigators hope to learn more about the effects of MS on pregnancy~     and pediatric development, and about the effects of pregnancy on the course of MS.~   "
15185|NCT03368144|"~     The BELTHROM trial investigates the efficacy and safety of the ClearLumen II Peripheral~     Thrombectomy System recanalization of acute and subacute thrombotic femoropopliteal~     occlusions (Acute Limb Ischemia (ALI); Rutherford I, IIa, IIb and III). An expected total of~     50 patients will be treated. The lesion is located within the femoropopliteal artery (native,~     in-stent or bypass graft). During the procedure, the device is introduced, activated and~     slowly advanced into the occlusion to clean out the wall-adherent thrombotic material. If~     residual underlying stenosis of >30% persists additional endovascular treatment can be~     performed according to the physician's discretion. Patients will be invited for a follow-up~     visit at 1 month post-procedure. The primary efficacy endpoint is the technical success of~     the ClearLumen II Peripheral Thrombectomy System, defined as removal of ≥90% acute clot as~     documented by angiography. The primary safety endpoint is defined as the absence of~     device-related complications, which is defined as embolization, perforation or dissection~     caused by the ClearLumen II Peripheral Thrombectomy System. Secondary endpoints include~     procedural success, percent clot removed by the ClearLumen II Peripheral Thrombectomy System,~     clinical success at 1 month follow-up visit, 30-day target lesion revascularization, 30-days~     serious adverse events and 30-days adverse events.~   "
15186|NCT03368131|"~     The purpose of this study is to assess the efficacy and safety of patients who receive~     concurrent neoadjuvant chemoradiotherapy for Siewert II ，III of locally advanced HER-2~     Positive adenocarcinoma at gastroesophageal junction~   "
15187|NCT03368118|"~     This study is an open-label study aiming at evaluating the long-term safety and the efficacy~     profile of ABX464 given once a day (o.d) at 50 mg in subjects who have been previously~     enrolled in the ABX464-101 clinical study (induction study) and who are willing to continue~     their treatment.~   "
15188|NCT03368105|"~     The aim of this study was to analyze whether the use of the LP299v strain reduces the risk of~     Clostridium difficile infection (CDI) among patients receiving antibiotics and hospitalized~     in the nephrology and transplantation ward.~      Patients from risk group (receiving immunosuppressive drugs and treated with antibiotics)~     were enrolled into study.~      Participants will be divided into two groups. First group will receive one capsule of~     Lactobacillus plantarum 299v (LP299v) orally per a day. Second group will receive placebo.~   "
15189|NCT03368092|"~     Severe hypoxemia following trauma may happen in many circumstances (aspiration,~     ventilation-associated pneumonia, lung contusion...), most of which are not exclusively~     associated with a direct injury to the lungs. Severe trauma and associated musculoskeletal~     injuries result in the acute release of Damage-Associated Molecular Patterns (DAMPs) in~     plasma, many of which are made of nucleic acids. DAMPs then bind leukocytes and trigger~     NETosis (Neutrophil Extracellular Traps), the release of nuclear material coated with~     proteolytic enzymes, which ultimately promotes remote lung injury and acute respiratory~     distress syndrome (ARDS).~      Considering that many DAMPs and all NETs are made of nucleic acids, we hypothesize that~     dornase alfa, a commercially available recombinant desoxyribonuclease (DNAse) could reduce~     DAMPs and NETs-induced lung injury in severe trauma patients under mechanical ventilation in~     the intensive care unit (ICU).~      The primary objective is to demonstrate a reduction in the incidence of moderate to severe~     ARDS in severe trauma patients during the first seven ICU days from 45% to 30% by providing~     aerosolized dornase alfa once during the first two consecutive ICU days and compared to~     equivalent provision of placebo (NaCl 0,9%).~      The secondary objectives are to demonstrate, by using aerosolized dornase alfa compared to~     placebo:~        -  an improvement in static lung compliance~        -  a reduction in mechanical ventilation duration / an increase in ventilation-free ICU~          days~        -  a reduction in the length of ICU stay~        -  a reduction in the hospital length of stay~        -  a reduction in multi-organ failure~        -  a reduction in ventilator-associated pneumonia (VAP)~        -  a reduction in mortality at day 28~   "
15190|NCT03368079|"~     Investigator initiated prospective study to determine whether the use of a negative pressure~     suction in the hypopharynx will reduce the amount of aspiration during Video Fluoroscopic~     Swallowing Exam (VFSE) among patients with oropharyngeal dysphagia~   "
15202|NCT03367923|"~     This randomized phase II trial studies how well a health and recovery program works in~     increasing physical activity level in stage IA-IIIA endometrial cancer survivors. Health and~     recovery program which includes exercise counseling, Fitbit tracker, and phone or email/text~     communication may increase the level of physical activity in endometrial cancer survivors and~     promote and maintain behavior change at a lower cost.~   "
15252|NCT03367273|"~     study & verify the hypothesis of the involvement of TSLP in the pathogenesis of vitiligo in~     comparison to their levels in the healthy control persons.~   "
15191|NCT03368066|"~     The hepatoadrenal syndrome has been well described in the literature and is known to be~     associated with poorer outcomes in both stable and critically ill cirrhotic patients. In~     chronic liver disease, adrenal (and more specifically cortisol) insufficiency is thought to~     be a byproduct of altered lipid metabolism that results in decreased HDL production and thus~     decreased delivery of cholesterol to the adrenal for subsequent corticosteroid production.~     Studies to date have implicated lecithin-cholesterol acetyltransferase (LCAT) as the key~     enzyme which is deficient in some cirrhotic patients, leading to an impaired ability to~     esterify cholesterol and thus a loss of normal cellular functioning and membrane stability.~     The investigators seek to quantify this LCAT deficiency in a cohort of cirrhotic patients and~     demonstrate its association with various abnormal physiologies associated with chronic liver~     disease, including spur cell anemia, low HDL levels, and adrenal insufficiency.~      Hospitalized cirrhotic patients at UVA that meet study eligibility criteria will be~     approached by a member of the study team to obtain consent for participation. If a patient~     agrees to become a study subject, they will have an approximate total of 35ml of blood drawn~     the following morning. Lab tests to be performed include: peripheral blood smear, lipid~     panel, free cortisol, cortisol binding globulin, serum cholesterol esters (surrogate for LCAT~     enzyme activity), and a standard-dose cortisol stimulation test. The latter involves blood~     drawn with the initial collection, administration of an intravenous 250mcg dose of synthetic~     ACTH, and then repeat small-volume blood draws at 30 minutes and 60 minutes later.~      Subjects will be classified as adrenally sufficient or insufficient on the basis of as~     standard-dose cortisol stimulation test. Variables of interest for comparison between the~     groups include MELD score, Child-Turcotte-Pugh (CTP) classification, high-density lipoprotein~     (HDL) levels, presence of spur cell anemia, serum cholesterol ester percentage (surrogate for~     LCAT enzymatic activity), cortisol binding globulin levels, and free cortisol levels.~     Student's t-test and Chi Square tests will be utilized to determine significance; a p <0.05~     value will be used as our threshold for significance. If multiple factors are found to be~     significantly different in a univariate fashion between classification groups, a multivariate~     logistic regression analysis will be performed for adjusted analysis. The investigators will~     also seek to define any correlations between variables. Furthermore, the investigators will~     assess correlation between MELD score and serum cholesterol ester percentage, spur cell~     anemia, HDL levels, cortisol binding globulin levels, and free cortisol levels; similar~     correlate analysis will be done using CTP classification instead of MELD score.~   "
15192|NCT03368053|"~     The purpose of this study is to evaluate the long-term persistence of binding antibody~     responses against V1V2 and gp120 in subjects who were vaccinated with the envelope~     glycoprotein 120 (gp120)-negative factor (Nef)Tat/ Adjuvant System 01B (AS01B) (GSKSB732461)~     vaccine candidate. Other immune parameters like the HIV-specific cluster of differentiation~     (CD4+) T cell and CD8+ T cell responses will also be evaluated.~   "
15193|NCT03368040|"~     The body core temperature drops during general anesthesia. To maintain homeostasis, patients~     require warming measures. Different methods to measure body core temperature exist, which are~     either highly accurate but invasive, or non-invasive but non-accurate. A new monitoring~     device, Tcore(TM), enables a non-invasive but accurate core temperature assessment.~      This study is performed to quantify accuracy and bias of the Tcore system in comparison with~     the blood temperature, which is the gold standard of core temperature measurement.~   "
15194|NCT03368027|"~     The aim of this study is to evaluate the efficacy of cognitive - behavioral therapy for the~     control of psychopathological stress and the disease of people with Retinitis Pigmentosa~     (RP).~   "
15195|NCT03368014|"~     Fun．Feel．Share＂ Lyrics-writing and Singing Show - A Pilot Project is part of the~     Community-based Mental Wellness Project for Adolescents and Adults, which aims at promoting~     Sharing, Mind and Enjoyment (SME) and enhancing mental well-being. The Mental Wellness~     Project is financially supported by the Health Care and Promotion Fund from Food and Health~     Bureau and led by the School of Public Health, University of Hong Kong (HKU).~     Fun．Feel．Share Lyrics-writing and Singing Show - A Pilot Project aims to promote the SME~     related behaviors of adolescents through intervention of physical activities, and to promote~     their happiness, well-being and mental health knowledge.~   "
15196|NCT03368001|"~     Our treatment, SENSE Theatre, combines several well-documented, effective behavioral~     strategies and theatre techniques. The proposed project will extend previous findings showing~     improving improvement in memory for faces. The multisite randomized control trial will~     include a large sample of 240 children with autism spectrum disorder (ASD) randomly assigned~     to the experimental (SENSE Theatre) or an active control condition (Tackling Teenage~     Together).~   "
15197|NCT03367988|"~     A comparison of post-operative opioid use in Laparoscopic Colectomy patients receiving Opioid~     or Opioid-free Anesthesia.~   "
15198|NCT03367975|"~     Near infrared spectroscopy is a valuable tool to monitor cerebral oxygenation during~     intracranial interventions. However, it yields artificial results when the dye indocyanine~     green (ICG) is applied, which is routinely done for intraoperative angiography.~      The investigators examine, to what extent and which duration NIRS is disturbed following ICG~     application.~   "
15199|NCT03367962|"~     This is a single-center imaging study to determine utility of in vivo imaging with~     [18F]F-AraG to identify sites of Graft Versus Host Disease (GVHD) in patients highly~     suspected of having acute GVHD who require systemic therapy, and patients at high risk for~     developing acute GVHD. [18F]F-AraG PET scans will be compared to biopsy results to correlate~     T cell accumulation which is implicated in the disease. High risk patients will be followed~     to verify predictive potential of [18F]F-AraG.~   "
15200|NCT03367949|"~     Dental model cast accuracy can be affected by many variables as tray material, impression~     material and time elapsed before pouring the impression. All these factors would affect the~     accuracy of the surgical guide~      Impression inversion with markers technique avoids the dimension changes that may happen from~     pouring of the dental model cast. Also it saves time as no need for optical scan of the model~     cast and for scan appliance even in cases of multiple restoration. Adding markers to~     impression tray ensures an accurate merge even if the patient has restored dentition that may~     cause scatter during the CT/CBCT scan.~      This study will is for Assessment of the Accuracy of Surgical Guide designed from Dental~     Model Optical Scan versus Impression Inversion with Markers techniques in Computer Guided~     Implantology.~   "
15201|NCT03367936|"~     The overall purpose of this randomized clinical trial is to examine the effect and efficacy~     of the individualized, real-time, smartphone-based feedback of diet and physical activity~     self-monitoring on subsequent weight-control behaviors, weight loss outcomes and~     sustainability of patient engagement. Participants will be randomized into one of 2 groups:~     (1) Self-Monitoring -similar to what many people do on the participant's own, subjects will~     self-monitor diet, physical activity using Fitbit and weight using a Bluetooth-enabled scale,~     and (2) Self-Monitoring +Feedback-participants will self-monitor as described for the~     Self-Monitoring group but also will receive tailored Feedback messages. The Self-Monitoring~     +Feedback participants will receive up to 4 daily discrete pop-up Feedback messages on the~     participant's smartphone delivered at random times during waking hours and tailored to~     content of recorded entries in the subjects' smartphone-based diaries and a weekly summary~     Feedback message about the participant's weight.~   "
15205|NCT03367884|"~     At the time of diagnosis, approximately 60%-80% of patients with hypopharyngeal cancer are~     found with cervical lymph node metastasis. Cervical nodal metastasis is an important~     prognostic factor in hypopharyngeal cancer. Induction chemotherapy is frequently used in~     advanced hypopharynx cancer. However, sometimes CR was obtained at the tumor's primary site~     but not in the palpable lymph nodes in the neck, the large cervical lymph node metastasis~     poorly responded to induction chemotherapy in a considerable percentage of patients. At~     present, patients with primary tumor achieved CR preferred to receive definitive radiotherapy~     no matter cervical lymph node metastasis SD or progression. But, radiotherapy was poor~     effective to the big cervical lymph node metastasis, because the inner of big cervical lymph~     node metastasis was hypoxic and necrosis. The investigators conducted a prospective,~     randomised trial to compare neck dissection with definitive radiotherapy for advanced~     hypopharyngeal cancer cervical lymph node metastasis with poor response to induction~     chemotherapy.~   "
15206|NCT03367871|"~     The investigators propose to evaluate the efficacy of the combination of cisplatin and~     paclitaxel with pembrolizumab in women with recurrent, persistent, or metastatic cervical~     cancer.~   "
15207|NCT03367858|"~     This is a randomized controlled trial to examine the impact of two brief interventions on~     adolescent and young adult alcohol use behaviors. The interventions being compared are~     motivational interviewing (MI) and brief adolescent mindfulness (BAM).~   "
15208|NCT03367845|"~     The proposed research is relevant to public health because of the critical importance of~     infant attachment and early experiences to the lifetime trajectory of mental health and~     socio-emotional functioning. This Randomized Clinical Trial addresses major gaps in available~     family-wide programs that can promote healthy development that best serve infants, mothers,~     fathers, and inter-parental relationships in cost-effective ways. This study also~     systematically tests for which families the interventions are most effective and rigorously~     tests the theoretical processes that link changes in mother-infant, father-infant, and~     mother-father interactions with infant and parent outcomes.~   "
15209|NCT03367832|"~     There are few data of paediatric peri-operative morbidity and mortality in South Africa.~     There is little information on the burden or profile of surgical disease in the paediatric~     population, the level of anaesthesia or surgical care (specialist versus non-specialist) for~     paediatric patients, the quality of peri-operative care or contributing factors to poor~     outcomes. In order to understand current paediatric peri-operative morbidity and mortality in~     South Africa, it is important to start obtaining these data. Risk factors can be identified~     and changes can be in implemented accordingly to improve future outcomes.~      The study will take place over fourteen-days. It is a South African national multi-centre~     prospective cohort study of paediatric patients (<16 years) undergoing surgery. The SAPSOS~     study (as was the South African Surgical Outcomes Study (SASOS) study) will be based on the~     methodology of the European Surgical Outcomes Study (EuSOS).~      This study has important public health implications for South Africa as surgery is now~     recognized internationally as an essential part of public health, yet still needs to be~     defined as a priority in South Africa. Policy-makers and healthcare providers need evidence~     to plan resource allocation in a way that will improve quality and outcomes. The data from~     SAPSOS and SASOS, would provide a platform for government and health care providers in South~     Africa to appropriately allocate funding, make policy decisions and plan future~     peri-operative healthcare in South Africa.~   "
15210|NCT03367819|"~     Primary Objectives:~        -  To characterize the safety and tolerability of isatuximab in combination with REGN2810~          in patients with metastatic, castration-resistant prostate cancer (mCRPC) who are naïve~          to anti-programmed cell death-1 (PD-1)/programmed cell death-ligand 1 (PDL-1)-containing~          therapy, or non-small cell lung cancer (NSCLC) who progressed on~          anti-PD-1/PDL-1-containing therapy, and to confirm the recommended Phase 2 dose (RP2D).~        -  To assess the response rate of isatuximab in combination with REGN2810 in patients with~          either mCRPC who are anti-PD-1/PDL-1 therapy naive, or NSCLC who progressed on~          anti-PD-1/PDL-1 therapy, or of isatuximab as single agent in patients with mCRPC.~      Secondary Objectives:~        -  To evaluate the safety of the combination of isatuximab with REGN2810 or isatuximab~          monotherapy.~        -  To evaluate the immunogenicity of isatuximab and REGN2810.~        -  To characterize the pharmacokinetic (PK) profile of isatuximab single agent or in~          combination with REGN2810, and to characterize the PK of REGN2810 in combination with~          isatuximab.~        -  To assess overall efficacy of isatuximab in combination with REGN2810 or as a single~          agent.~   "
15211|NCT03367806|"~     Previous studies suggested an inverse relationship between coffee consumption and mortality~     in the general population. Furthermore, an inverse association between coffee consumption and~     serum biomarkers of inflammation and insulin resistance has been described. Prospective~     studies showed that coffee consumption might be associated with reduction in the incidence of~     type 2 diabetes. Although caffeine consumption appears to be associated with a decreased risk~     of developing type 2 diabetes, the relationship between caffeine consumption and mortality in~     patients with diabetes remains uncertain. The current analysis aimed to assess the effects of~     caffeine consumption and caffeine source on all-cause, cardiovascular and cancer mortality~     among patients with diabetes.~   "
15212|NCT03367793|"~     This study tests the hypothesis that objectively derived spectacle prescriptions based on~     wavefront aberration measurements of the eyes of individuals with Down syndrome can provide~     an improvement in visual acuity over that obtained with spectacle prescriptions based on~     standard clinical prescribing techniques. The objectively derived prescriptions are derived~     using strategies to optimize retinal image quality as measured by image quality metrics, and~     thus these prescriptions will be referred to as metric-derived.~   "
15253|NCT03367260|"~     The primary objective of this study is to apply best-practice stated-preference methods to~     quantify the extent to which women with ovarian cancer accept the risks, side effects, and~     out-of-pocket costs associated with treatment in return for progression-free survival benefit~     afforded by a treatment, regardless of whether there is an overall survival benefit.~   "
15254|NCT03367247|"~     This research study is evaluating a new intervention, BOLSTER, which was designed to provide~     more support for patients with ovarian cancer and their caregivers after a hospitalization.~   "
22303|NCT03275103|"~     This is a phase I, multicenter, open-label, dose-escalation study of BFCR4350A administered~     as a single agent by IV infusion to participants with relapsed or refractory multiple myeloma~     (R/R MM).~   "
15213|NCT03367780|"~     Optimization of radiotherapy to reduce xerostomia is difficult, because many gland locations~     cannot be seen with current imaging modalities and biological dose‐effect are currently~     insufficiently understood. PSMA PET is a new diagnostic instrument which can visualize the~     presence of vital acinar cells in salivary gland locations throughout the head and neck, with~     a sensitive and quantitative signal. A reduction of PSMA accumulation in salivary glands is~     thought to correlate with loss of vital acinar cells. The PET images can be correlated with~     radiotherapy dose distributions in gland‐based or voxel‐based evaluations. This makes PSMA~     PET a suitable instrument to derive the radiobiological dose‐effect relations that are~     required to develop better and gland‐specific dose constraints for radiotherapy. The results~     of this study can contribute to lower toxicity and better quality of life in patients treated~     with high‐dose radiotherapy in the head and neck.~   "
15214|NCT03367767|"~     Background:~      Age-related macular degeneration (AMD) and cataracts are two eye diseases. They were studied~     in the Age-Related Eye Disease Study (AREDS2) and the AREDS2 Follow-On study. These studies~     followed the natural course of the diseases. They also provided data on the long-term effects~     of certain oral supplements on AMD.~      Objective:~      To study the long-term effects of oral supplements on several things. These include~     incidences of lung cancer, development of late AMD, cataract surgery, cognitive function, and~     cardiovascular events.~      Eligibility:~      Former AREDS2 and AREDS2 Follow-On participants~      Design:~      Participants will have 1 visit. It will include:~      An eye exam that tests how well participants can see, measures eye pressure, and checks eye~     movements. The pupil will be dilated with eye drops. Pictures will be taken of the retina and~     the inside of the eye.~      Participants will grip a device in their hand to measure their grip strength.~      A blood sample will be taken. This will be stored for future genetic research. Cells may be~     created from the sample.~      A small sample of skin will be taken.~      Sponsoring Institution: National Eye Institute~   "
15215|NCT03367754|"~     Background:~      Human immunodeficiency virus (HIV) attacks the immune system. Some people with HIV have a low~     CD4+ T-cell count despite taking antiviral medicines that control HIV replication. These~     cells fight disease, so a low count makes it easier for people to become sick. Researchers~     want to see if a new drug can improve the immune system, including T cells. The drug is~     called pembrolizumab~      Objective:~      To see if pembrolizumab is safe to use in people with HIV who have a low CD4+ T cell count~     despite taking medcines that control HIV replication, and to see if it strengthens the immune~     system.~      Eligibility:~      People age 18 years or older with HIV who are taking antiretroviral drugs as treatment, have~     blood HIV levels below detection limits of commercial assays, and have a low CD4+ T-cell~     count (below 350 cells/mm3).~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Heart, blood, and urine tests~      Sexually active participants must use 2 kinds of birth control.~      Participants will have leukapheresis. Blood will be removed through a needle in one arm. A~     machine will remove white blood cells. The rest of the blood will be returned into the other~     arm.~      Participants will have a baseline visit. They will have blood tests. They may have a~     pregnancy test.~      A needle will insert a thin plastic tube (IV) into an arm vein. The participants will get the~     study drug or a placebo through the IV for 30 minutes. They will be watched for a couple~     hours after.~      Participants will have 11 follow-up visits over the next 48 weeks. They will have a physical~     exam, vital signs, medical review, and blood tests.~      Participants may have another leukapheresis.~      Participants will be called every 12 weeks after their last follow-up visit to talk about how~     they feel and their health. Participation ends after the week 96 phone call.~      Sponsoring Institute: National Institute of Health Clinical Center~   "
15216|NCT03367741|"~     This randomized phase II trial studies how well cabozantinib and nivolumab work in treating~     patients with endometrial that has come back or spread to other places in the body.~     Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth. Monoclonal antibodies, such as nivolumab, may interfere with the ability of~     tumor cells to grow and spread. Giving cabozantinib and nivolumab may work better in treating~     endometrial cancer.~   "
15217|NCT03367728|"~     Randomized, Double-Blinded, Placebo-Controlled Trial of Laparoscopic Transverse Abdominis~     Plane (Lap TAP) and Rectus Sheath Block in elective Gastric Bypass Surgery aiming to evaluate~     the benefit of a laparoscopically -guided, surgical transversus abdominis plane (TAP) block~     and rectus sheath block in reducing post-operative opioid consumption and improving outcomes~     in patients undergoing laparoscopic gastric bypass surgery. The results of this study will~     provide further evidence on the optimal means to obtain analgesia in patients undergoing~     gastric bypass surgery~   "
15218|NCT03367715|"~     This is a single arm, open-label, phase II trial of nivolumab, ipilimumab and short-course~     radiation therapy in adult patients with newly diagnosed, MGMT unmethylated GBM with the~     primary objective of determining the overall survival at 1 year.~   "
15219|NCT03367702|"~     This randomized phase III trial studies how well stereotactic body radiation therapy works~     compared to intensity-modulated radiation therapy in treating patients with stage IIA-B~     prostate cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink~     tumors. Stereotactic body radiation therapy is a specialized radiation therapy that sends~     x-rays directly to the tumor using smaller doses over several days and may cause less damage~     to normal tissue. Stereotactic body radiation therapy may work better in treating patients~     with prostate cancer.~   "
15220|NCT03367689|"~     This is an international, multi-centre, non-controlled, open-label, single arm, two-stage~     Simon Design phase II study for non-BRCA metastatic breast cancer (MBC) patients with~     homologous recombination deficiency treated with Olaparib single agent.~      The main objective is to assess the efficacy of olaparib single agent as determined by~     Clinical Benefit Rate (CBR) using the Response Evaluation Criteria in Solid Tumors (RECIST~     1.1).~      In the first stage Triple negative (TN) non-BRCA, metastatic breast cancer (MBC) patients~     whose tumours exhibited any characteristic related to homologous recombination deficiency~     (HRD). In the second stage, luminal patients (RH positive HER2 negative) will be allowed in~     the same conditions that TN.~      Patients whose tumours are identified as Homologous Recombination Deficient by deleterious~     HRR gene mutations (according to Foundation Medicine's Foundation One assay) will receive~     olaparib 300 mg (two tablets of 150mg) orally twice daily (bid) on days 1-28 each 28 days.~      Study commitment is 39 patients: 17 patients will be enrolled at first stage and 22 at the~     second stage.~      The total duration of the study period is 34 months.~   "
15221|NCT03367676|"~     This phase II trial aims to study the efficacy and safety of 12 weeks adjuvant docetaxel plus~     trastuzumab in patients with tumors ≤1cm, node-negative, HER2-positive breast cancer.~   "
15222|NCT03367663|"~     Glucocorticoids (GCs) are a class of endogenous steroid hormones produced by the adrenal~     glands and controlled by the hypothalamic-pituitary-adrenal axis (HPA). One of the mechanisms~     of their action is achieved through ligand-receptor attachment to a class of cytosolic~     steroid hormone receptors termed Glucocorticoid Receptors (GRs). The formed ligand-receptor~     complex is a transcription factor involved in gene activation of anti-inflammatory products~     or repression of pro-inflammatory products [1]. Synthetic forms of GCs are a group of~     anti-inflammatory and immunosuppressive medications (e.g. Prednisone) that are widely used in~     clinical practice to treat inflammatory diseases (e.g. Rheumatoid Arthritis, Vasculitis,~     Asthma). The effectiveness of this class of drugs is limited by numerous adverse effects that~     include, but not limited to, insulin resistance, glucose intolerance, dyslipidemia, and~     hypertension, all of which are well known risk factors for cardiovascular diseases (CVD)~     [2,3]. Furthermore, recent research suggest that inflammation has a key role in development~     of CVD and can predict prognosis [4]. Inflammatory cells have an important role in the~     development of atherosclerotic lesion in the arteries. Blood monocyte-derived macrophages are~     involved in this process, and they infiltrate the lesion where they take up various forms of~     lipids (cholesterol - rich LDL, and oxidized LDL) as well as triglycerides - rich VLDL),~     followed by the formation of lipid-laden foam cells, the hallmark of early atherogenesis.~     Inflammatory cells and molecules as well as proteolytic enzymes secreted from inflammatory~     cells in the atherosclerotic lesion, have a central role in destabilizing the plaque~     (vulnerable plaque) leading to its rupture, which, in turn, induces thrombosis, and~     initiating acute coronary events [4,5].~      Based on our understanding of the involvement of inflammation in the early development of~     atherosclerotic lesion, and our experience with the anti-inflammatory effects of synthetic~     GCs, a hypothesis emerged suggesting this class of drugs as a way to inhibit early~     atherosclerotic plaque formation, and to attenuate CVDs [6]. Research results in this field~     are surprising because while glucocorticoids treatment in humans increase the risk of CVDs~     [6,7,8,9], animal models shows the opposite, atheroprotection was shown in rabbits [10,11,12]~     and mice [13,14,15]. This paradox may be explained partially by the fact that clinical~     studies in this field are mainly conducted in patients with predisposing factors to develop~     CVD, either because of pre-existing traditional risk factors like Diabetes and~     Hyperlipidemia, or because of the pre-existing medical condition they are being treated for~     with GCs (e.g. Rheumatoid Arthritis). Mechanism based research to study the effects of GCs on~     atherogenesis, without confounding factors, is lacking. Only few studies were performed on~     GCs in healthy subjects but none of them explored their effects on foam cell formation~     [16,17].~      Our study thus aims to further our understanding of the role of specific glucocorticoid,~     prednisone, in the process of atherogenesis. In order to achieve that we plan to study the~     following: 1. The effects of five days of treatment with prednisone on serum lipid~     concentration and oxidative stress. 2. an Ex-vivo study is planned where the serum of healthy~     human subjects treated with Prednisone, will be introduced to J774A.1 murine macrophage-like~     cell line, a well-studied macrophage foam cell formation model.~   "
15321|NCT03366376|"~     This study evaluates hippocampus-sparing whole-brain radiotherapy with simultaneous~     integrated boost for patients with multiple brain metastases from non-small cell lung cancer.~     The primary endpoint is intracranial progression free survival, and secondary endpoints are~     verbal neurocognitive function, overall survival, adverse events according to CTCAE v4.03,~     and quality of life.~   "
15223|NCT03367650|"~     The diagnosis and the follow-up of the patients reached of SLA is centralized, since a few~     years, at the the Caribbean Reference center of the rare neurological diseases (CERCA~     labélisé in 2006) in Martinique and at the Unity of coverage of the neuromuscular Diseases,~     SLA and the rare neurological diseases (create in 2010) in Guadeloupe. Several phenotypic~     characteristics seemed to us to take out again data collected during the follow-up of the~     patients (26 in Guadeloupe, since the creation of the unity) in particular patients' high~     proportion of exceptionally long evolution (more than 10 years). Besides, we diagnosed~     several cases (10 cases in Guadeloupe since 2000) of association SLA- Parkinsonien Syndrome.~      This association, considered as exceptional could establish a particular phenotypic entity~     which we would like to describe. We are interested also originally geographical of the~     patients, with the hypothesis that he could exist in the Antilles one or several geographical~     isolates of the disease allowing to lead a étiologique investigation in search of a possible~     genetic or environmental cause.~   "
15224|NCT03367637|"~     Palliative care is an approach that improves the quality of life of patients and their~     families facing the problem associated with life-threatening illness such as cancer, through~     the prevention and relief of suffering by means of early identification and treatment of pain~     and other physical and psychosocial problems. Despite the rising incidence of cancer, the~     availability of comprehensive palliative care services across Sub Saharan Africa is extremely~     limited. The current study will test the efficacy of the newly developed smart phone based~     symptom evaluation app (application), in improving the management of the palliative care~     needs of patients with advanced cancer in Rwanda.~      RPCHO is the Rwanda Palliative Care and Hospice Organization that provides palliative care~     services to advanced cancer patients in Rwanda. About 80 patients enrolled under the RPCHO~     will be enrolled in the current study. Those who agree to take part in the study will be~     randomly assigned to either a standard care group or intervention group. Patients in both the~     arms will continue to receive the standard palliative care currently provided at the RPCHO.~     Additionally, patients in the intervention group will receive new smart-phone application~     based alerts, bi-weekly, on their mobile phone to fill out the short symptom assessment form.~     In addition, patients will also be able to complete a symptom assessment at any time they~     feel that their symptoms are poorly controlled or getting worse. The team at RPCHO will have~     desktop based dashboard where they will be able to track all patient's information. This will~     assist them in early identification and response to any worsening symptoms. Patients enrolled~     in both standard arm and intervention arm, will be asked to make three visits at the RPCHO at~     baseline, at 6 weeks, at 3 months. During this visits the RPCHO research staff will conduct~     their physical and psychological assessment.~      We hope to find significant improvement in pain score, other symptoms and quality of life, as~     measured by standard validated scores, for patients enrolled under the intervention arm~     (using the smart phone app) as compared to standard care arm at 6 weeks and at 3 months. Thus~     we hope to demonstrate that the new smartphone-based app can be successfully used for both~     the assessment and management of pain and other symptoms and providing palliative care~     services for advanced cancer patients in low and middle income countries.~   "
15225|NCT03367624|"~     Secondary bacterial influenza pneumonia caused by Panton-Valentine Leukocidin Positive~     Staphylococcus aureus is a rare complication but with poor prognosis. This pathology seems to~     affect young patients (20-40 years) without any medical history. Since the influenza pandemic~     of 2009, this complication is more and more mentioned, sought and diagnosed. However, the~     literature is poor, consisting of case reports, experimental studies on murine models, and~     low-power studies.~      The main objective is to evaluate the mortality in intensive care units of patients~     post-influenza bacterial pneumonia due to a Panton-Valentine Leukocidin positive~     Staphylococcus aureus~   "
15226|NCT03367611|"~     Background: Colorectal cancer (CRC) is one of the most common types of cancer in Denmark, and~     mortality among patients is high. Patients presenting with alarm symptoms of CRC are referred~     to colonoscopy in the cancer patient pathway for CRC. However, the proportion of patients~     with alarm symptoms who have CRC is below 10%. Simultaneously, the burden on endoscopy units~     to conduct fast-track colonoscopies is growing.~      Occult blood in the faeces may be an early sign of cancer or precancerous lesions, and can be~     detected by an immunochemical faecal occult blood test (iFOBT). Few studies have examined the~     diagnostic properties of the iFOBT among symptomatic patients, and reported sensitivities~     ranging from 88%-100%, specificities from 77%-94%, and negative predictive values from~     98%-100%. These results were derived from diverse patient populations, and used different~     cut-offs to define positive test results. Using iFOBT may be a valuable tool for the GP when~     deciding on referral of the patient to the cancer patient pathway. However, evidence is~     needed on the diagnostic accuracy of the test to detect CRC among patients presenting with~     alarm symptoms.~      Hypothesis: In patients presenting with alarm symptoms of CRC, detection of faecal occult~     blood by iFOBT is an accurate measure of the presence of colonic lesions.~      Aim: The aim of the study is to examine the diagnostic accuracy of the iFOBT among~     symptomatic patients referred to colonoscopy in the cancer patient pathway for CRC.~      Materials and methods: The project is conducted as a diagnostic accuracy study. Patients~     appointed for colonoscopy will be invited to collect a faecal sample and mail it for~     analysis. The iFOBT result will be registered in a computer-based laboratory information~     system. The result of the colonoscopy will be registered in Danish national health~     registries. The sensitivity, specificity, positive predictive value and negative predictive~     value will be calculated as measures of the diagnostic properties of the iFOBT, using the~     result of colonoscopy as the reference standard. The accuracy of the test by type of alarm~     symptom will also be assessed.~      Perspectives: The study will provide new and valuable data to evaluate the referral criteria~     for the cancer patient pathway. Given a good discriminatory ability of the iFOBT among~     symptomatic patients, fast-track colonoscopy may not be necessary as a first-choice~     examination in the diagnostic work-up of these patients.~   "
15227|NCT03367598|"~     The aim of this study is to evaluate whether the longitudinal interaction between APOA5~     -1131C variants and overweight could accelerate age-related increases in arterial stiffness~     and circulating triglycerides in healthy subjects.~   "
15228|NCT03367585|"~     Introduction: In Brazil, a person who is sixty years old or more is considered elderly. The~     incidence of osteoporosis and osteopenia has been increasing, as have fractures resulting~     from falls. Vitamin D deficiency can cause muscular atrophy in type II fibers (fast~     contraction and strength), which can increase the risk of falls. The aging process produces~     reduction in the ability of postural control system to maintain postural balance, which may~     increase postural instability and consequently increase the elderly risk to falls. Objective:~     To evaluate if vitamin D supplementation associated with regular exercise in vulnerable older~     women improves muscle strength and postural balance in 12 weeks. Methods: This will be a~     randomized prospective clinical trial, double blind, placebo-controlled intervention. Will be~     part of the study 40 elderly women vulnerable, who meet the inclusion criteria and that will~     be coming from the community through calls made by radio and social network. The volunteer~     will undergoing to blood test, body composition and bone mineral density, Mini Mental State~     Examination, Geriatric Depressive Scale, Falls Efficacy Scale, WHOQOL-OLD and WHOQOL-BREF~     instruments, functional capacity tests (MiniBEST, Time up and Go, Chair Rising Test,~     Six-minute walk test), muscular strength assessment (isokinetic dynamometry, handgrip and 1RM~     test) and postural balance (AccSway force platform for static postural balance and NeuroCom's~     Balance Master for dynamic postural balance) before and after 12 weeks of intervention with~     vitamin D supplementation and resistance and postural balance exercise. The intervention that~     will be perform during the 12 weeks with a progressive resistance training program.~   "
15229|NCT03367572|"~     This randomized phase III trial studies how well netupitant/palonosetron hydrochloride and~     dexamethasone with prochlorperazine or olanzapine work compared to netupitant/palonosetron~     hydrochloride and dexamethasone in improving chemotherapy-induced nausea and vomiting in~     patients with breast cancer. Antiemetic drugs, such as prochlorperazine and olanzapine, may~     help lessen nausea and vomiting in patients with breast cancer treated with chemotherapy.~   "
15230|NCT03367559|"~     An open label study to evaluate immunogenicity, safety, and reactogenicity of Rotavac® (live~     attenuated oral rotavirus vaccine) as a 3-dose series in healthy infants aged between 6 weeks~     and 8 weeks in Vietnam.~   "
15233|NCT03367520|"~     Given the high prevalence and great cost of smoking for individuals with serious mental~     illness, an effective smoking cessation intervention for this group of smokers that begins in~     the hospital and continues following discharge is needed. The investigators will develop and~     pilot test StayQuit, a multifaceted smoking cessation intervention for smokers with serious~     mental illness that begins in the hospital and continues for three months after discharge.~     StayQuit will provide a personalized and tailored experience for smokers with serious mental~     illness at different levels of motivation to remain abstinent. In the hospital, StayQuit will~     include a brief motivational intervention that will help smokers relate sustained smoking~     cessation to their values and preferences, shore up motivation to stay quit, and gain~     experience using nicotine replacement therapy. This will be followed by cessation-focused~     discharge planning to engage Veterans in continued smoking cessation services with StayQuit~     staff. After discharge, StayQuit will offer 13 weeks (spread out over 3 months) of smoking~     cessation telephone counseling. The investigators will examine the feasibility of StayQuit by~     collecting both quantitative data on attendance and qualitative data on participants'~     experiences.~   "
15234|NCT03367507|"~     Although the vast majority of individuals sustaining a sport-related concussion (SRC) will~     receive medical clearance to return to sport within 7-10 days, approximately 30% of children~     and adolescents reporting to the emergency department will experience symptoms that last~     longer than a month. Research has demonstrated that exercise below the threshold that results~     in increases in symptoms, beyond those experienced at rest, (sub-symptom threshold aerobic~     exercise) may be beneficial in recovery. However, the optimal amount and intensity of aerobic~     exercise for an individual to experience the most beneficial outcomes is currently unknown.~     Unfortunately there are limited Randomized Controlled Trials (RCT's) evaluating the benefits~     of aerobic exercise in a youth population. The current evidence includes studies with~     relatively small sample sizes, unreliable measurements of physical activity (self-report),~     and inherent biases through inadequate blinding. There is a need to develop and validate~     evidence-informed interventions as a means of treatment for limiting time loss from sport,~     and school in adolescents who experience persistent symptoms of sports related concussion~     beyond 10 days.~   "
15235|NCT03367494|"~     Cystic Fibrosis (CF) is a hereditary multi-system disease affecting approximately 30,000n~     children and adults in the USA. The diagnosis of CF requires biochemical confirmation (either~     abnormal sweat chloride measurement and/or identification of two CF disease causing~     mutations) plus clinical symptomatology. Measurements of sweat chloride remain cumbersome and~     although most common methodology to confirm CF diagnosis with limitations especially in young~     children less than 6 months of age and in areas that lack ability for the complex testing.~     The study objectives of this current research proposal include: A) To expand upon previously~     obtained pilot study data Evaluation of a fluorescent-based chloride sensor as an optical~     sweat test to diagnose cystic fibrosis B) To add the exploratory measurement of sweat~     Bromide as a first in human assessment observation, C) To Evaluate the development of~     smartphone based point-of-care technology for chloride and bromide sensor measurements, D) To~     further expand the class of citrate-based sensors with improved fluorescence and sensing~     properties for the design of new fluorescence-based analytical and diagnostic solutions based~     on the automated multi-halide detection system, and E) To develop point-of-care systems that~     can successfully integrate into clinical settings to improve current practices and facilitate~     early detection of disease.~   "
15236|NCT03367481|"~     Gingival fissures (GF) have been suggested as risk indicators for clinical attachment loss~     (CAL) and gingival recession, especially in free surfaces and in patients with low plaque~     scores. The major factors related to the GF occurrence are high daily brushing frequencies,~     excessive force to brush, malpositioned teeth, use of abrasive dentifrices, and stiffness of~     the toothbrushes bristles. In this scenario, in order to better understand the pathogenesis~     and progression of GF, this study aim to evaluate the incidence and behavior of GF in young~     adults using soft and medium brushes, in a cross-over randomized clinical trial along 6~     months.~   "
15237|NCT03367468|"~     Plantar fasciitis is seen common in clinics and responsible from most of foot related pain~     problems. There are many treatment modalities in the literature as well as there is no golden~     standard to treat plantar fasciitis in non-surgical ways. The aim of this study is to compare~     intensive physiotherapy program, home based exercise program and control group decide the~     most effective rehabilitation program in plantar fasciitis.~   "
15238|NCT03367455|"~     The investigators propose to study the association of the KCNJ11 (Potassium Voltage-Gated~     Channel Subfamily J Member 11) polymorphisms on diabetes risk in the Atherosclerosis Risk in~     Communities (ARIC) and Jackson Heart Study (JHS) cohorts. The investigators also propose to~     test for an interaction between serum K and these genetic variants. By testing for such an~     interaction, it will be determined if, among participants with these genetic variants, a~     low-normal serum K was a stronger predictor of diabetes risk compared to those participants~     without these genetic variants.~   "
15239|NCT03367442|"~     Traumatic chest injuries are responsible for significant morbidity and the cause of~     trauma-related death in 20%-25% of cases. Thoracic trauma can include multiple injuries,~     mainly osseous (ribs, sternal fractures, flail chest), pulmonary contusions or lacerations,~     pneumothoraces and pleural effusions, and sometimes involve wounds to the heart and vessels~     (aortic dissection, cardiac contusion) or diaphragm. Following trauma, patients with thoracic~     injuries are at risk of developing acute respiratory distress syndrome (ARDS). This worsening~     of respiratory function can lead to requirement for mechanical ventilation. In addition,~     changes to gas exchange may also be generated or aggravated by mechanical ventilation as a~     result of barotrauma, biotrauma, or ventilation-associated pneumonia. Many mechanical~     ventilation strategies have been tried in trauma patients in the last 30 years to determine~     the optimal method of maximizing gas exchange with minimal lung damage. The driving pressure~     of the respiratory system has been shown to strongly correlate with mortality in a recent~     large retrospective ARDSnet study. Respiratory system driving pressure [plateau~     pressure−positive end-expiratory pressure (PEEP)] does not account for variable chest wall~     compliance especially in cases of chest trauma. Esophageal manometry can be utilized to~     determine transpulmonary driving pressure. A recent study suggests that utilizing PEEP~     titration to target positive transpulmonary pressure via esophageal manometry causes both~     improved elastance and driving pressures. Treatment strategies leading to decreased~     respiratory system and transpulmonary driving pressure at 24 h may be associated with~     improved 28 day mortality. However, currently no specific study with chest trauma patients~     exists. We propose to investigate the effect of hight transpulmonary driving pressure on~     duration on mechanical ventilation, length of stay and mortality in patients with sever chest~     trauma.~   "
15913|NCT03358641|"~     Wuchuan Osteoarthritis Study is a population-based longitudinal study of natural history of~     knee osteoarthritis and its risk factors. At baseline and follow-up visits, IPA-Q~     questionnaire and a radiographs at tibiofemoral (TF) joints will be taken in order to assess~     the relationship between physical activity and radiographic osteoarthritis worsening.~   "
15240|NCT03367429|"~     Despite the wide-spread use of botulinum toxin (BT) to treat spasticity (increased muscle~     tone) in central neurological disease, evidence-based guidance on dosing, dilution, and~     injection technique is limited. The wide-spread use of BT in spasticity management, expense~     of these agents, and detrimental impact from movement into non-injected muscles mandates a~     better understanding of BT movement within muscles. A proof-of-concept paper written by~     investigators at Weill Cornell Medicine introduced a non-invasive MRI approach with voxel~     thresholds that was able to detect intramuscular effects of BT at 2 and 3 months~     post-injection of BT. The purpose of the current set of studies is to refine this MRI~     technique to better visualize the movement of botulinum toxin through muscle. In addition,~     the investigators plan to explore, using the imaging technique, how spastic muscle and~     differing dilutions affect BT movement in an effort to support the development of better~     research techniques to study toxin movement in human muscle.~   "
15241|NCT03367416|"~     The proposed research will test the ability of the NIATx Organizational Change Model to~     improve patient no-show rates as compared to typical training approaches used in dental~     offices. The purpose of the pilot study is to improve no-show rates and, in the process, test~     an evidence-based organizational change model that can increase use of evidence-based~     practices in dental care.~      NIATx is not an acronym, it is a proper noun.~   "
15242|NCT03367403|"~     The purpose of this study is to evaluate the safety, tolerability and efficacy of LY3002813~     alone and in combination with LY3202626 in early symptomatic Alzheimer's disease.~   "
15243|NCT03367390|"~     The Automated Insulin Delivery (AID) System is an investigational insulin delivery device~     being developed for use for participants with diabetes. The purpose of this study is to~     assess the safety of the AID system and to test whether the AID System functions as it was~     designed to.~      This study will last approximately 12-18 days, not including screening. Screening is required~     within 28 days prior to the start of the study.~   "
15244|NCT03367377|"~     This study will evaluate the safety and tolerability of LY3209590 when given by injection~     under the skin to participants with type 2 diabetes. It will also investigate how the body~     processes the study drug and the effect of the study drug on blood sugar levels. Information~     about any side effects will be documented.~      This study will last approximately 17 weeks, not including screening. Screening is required~     within 4 weeks prior to the start of the study.~   "
15245|NCT03367364|"~     VTE associated harm is underappreciated among hospitalized patients and may be associated~     with missed doses of VTE prophylaxis medications. In order to ensure best practices, and~     administer a defect-free VTE prevention nurses must understand and educate patients on the~     importance of the VTE prophylaxis. We propose to conduct a randomized trial comparing the~     effect of a validated, real-time patient education bundle (PEB), to a program of nurse~     feedback and coaching (NFC) provided by nurse leaders.~   "
15246|NCT03367351|"~     The goal of this pilot study is to produce a high-quality, theory-driven, therapeutic,~     web-based intervention that provides extended training and peer support to adolescents and~     young adults with type 1 diabetes who are newly implementing CGM. Overall, this web-based~     intervention represents an efficient way to bring together professionally-supported CGM~     educational materials and social support to overcome known barriers and address factors~     associated with inconsistent CGM use.~   "
15247|NCT03367338|"~     The aims of the study are to evaluate the effect of low-phosphate diet on FGF23 level and to~     determine the optimal amount of dietary phosphate restriction in hemodialysis patients. In~     particular, the investigators will assess the effect of pre-specified low-phosphate diets~     with two different phosphate amounts, 600 mg/day and 800 mg/day, on the changes of FGF23~     level.~   "
15248|NCT03367325|"~     Atrial fibrillation (AF) is the most common cardiac arrhythmia and increases the risk of~     ischemic stroke 4-5-fold. The prevention of complications is based on oral or antiplatelet~     anticoagulant treatment. The first choice of anticoagulant therapy (AT) is the vitamin K~     antagonist (VKA). Contraindication to VKA or poor control of the International Normalized~     Ratio leads to the administration of direct-acting oral anticoagulants (DOACs). There is a~     trend towards inadequate AT in non-valvular AF (NVAF) patients.~      The Objective of the study is evaluate the impact of the implementation of a decision support~     tool linked to digital clinical history on the adequacy of AT, the incidence of complications~     and the mortality in patients with NVAF in primary health care of the Catalan Institute of~     Health (ICS).~   "
15249|NCT03367312|"~     This study seeks to deploy several forms of 129Xe MRI contrast as well as emerging~     conventional proton MRI techniques for imaging lung structure and perfusion. Specifically,~     the 129Xe MRI scans will provide 3D images of ventilation and gas exchange, and spectroscopic~     indices will be evaluated too test gas exchange dynamics with high temporal resolution. The~     conventional 1H MRi scans will include a free-breathing ultra-short echo time scan that~     provides images similar to that of a CT scan. This will be done pre, immediately post, and~     2-4 hours post inhaled prostacyclin therapy.~   "
15250|NCT03367299|"~     The present study aims at analyzing the response to treatment of adult patients homogeneously~     treated with supportive care, chemotherapy and blinatumomab.~   "
15251|NCT03367286|"~     Acute ischemia stroke (AIS) is the leading cause of death in China. Thrombolytic therapy with~     recombinant tissue plasminogen activator (rt-PA) has been proven to reduce disability in AIS~     patients within 4.5 hours after symptom onset. However, only 2% of AIS patients received~     thrombolytic therapy in China.~      Perfusion imaging is demonstrated to increase the rate of thrombolytic therapy by identifying~     the ischemic infarct core (the brain tissue that is irreversibly injured) and the ischemia~     penumbra (the brain tissue surrounding the ischemia infarct core that is hypoperfused but~     still viable) for those patients with extending therapeutic window (beyond the current 4.5~     hours after symptom onset), as well as minor stroke or those with atypical symptoms.~      Three prospective clinical trials, DEFUSE, DEFUSE-2 and EPITHET, has confirmed that mismatch~     between perfusion weighted-imaging (PWI) and diffusion weighted-imaging (DWI) correspond to~     the ischemic penumbra whereas DWI provides information of the ischemia infarct core and major~     reperfusion relate to good clinical outcome in extending therapeutic window AIS patients with~     DWI-PWI mismatch.~      Computed tomography perfusion (CTP) may be a potential alternative technology for recognition~     of reversibly damaged brain tissue in AIS patients, with the prominent advantage of fast~     scan. Recent studies also demonstrated that CTP could select eligible candidates for~     reperfusion therapy. More recently, with data of EXTEND-IA, reperfusion therapy in AIS~     patients with CTP mismatch (using a CT time to maximum >6 s as ischemic hypoperfusion volume~     and a CT relative cerebral blood flow <30% of that in normal tissue as ischemic core volume)~     were related to good clinical outcome.~      However, plenty of studies demonstrated CT cerebral blood volume did not always predict~     ischemic infarct core in AIS patients. A recent study also confirmed the poor contrast: noise~     ratios of CT cerebral blood volume and CT cerebral blood flow result in large measurement~     error, compared with those of diffusion weighted imaging (DWI), making it problematic to~     substitute DWI in selecting individual AIS patients for reperfusion treatment.~      Based on those studies, it is still remained unclear whether CTP can be an alternative choice~     to replace magnetic resonance perfusion (MRP) in AIS patients with extending therapeutic~     windows. So in this study, the investigators try to determine whether baseline CTP profiles~     have a comparable ability to MRP in identifying patients who have a robust clinical response~     after early reperfusion.~   "
15255|NCT03367234|"~     This study evaluates the effectiveness of integrating empirically-supported treatments for an~     opioid use disorder into a primary care setting. These treatments will include ASAM Criteria~     multidimensional assessment, cognitive behavioral therapy and relapse prevention with~     contingency management, medication-assisted treatment, and recovery support services. Half of~     participants will be assigned to opioid use disorder treatment in a federally qualified~     health center, and half will receive treatment at a publicly-funded intensive outpatient~     addiction treatment program which has the ability to offer medication-assisted treatment.~   "
15256|NCT03367221|"~     Primary Graft Dysfunction (PGD) respresents the leading cause of mortality in early~     post-operative period of Lung Tranplantation (LTx). Protective ventilatory strategy could~     potentially reduce the risk of PGD in these patients. Neurally Adjusted Ventilatory Assist~     (NAVA) is an assisted ventilation mode that could allow to adopt this strategy. Aim of the~     study is to assess the feasibility of NAVA in the early post-LTx phase and to describe the~     breathing pattern and the physiological relationship between neural respiratory drive and~     different levels of ventilatory assist, in the absence of pulmonary vagal afferent feedback.~   "
15257|NCT03367208|"~     The breast cancer is composed of multiple biological entities. Recent progress in molecular~     biology, DNA or RNA chip, permitted the global tumour genome or transcriptome study. Those~     technics, leads to an increased in the molecular biology knowledge and a better oncogenesis~     understanding. Breast cancer taxonomy was established following the tumor genetic profile.~     Moreover this classification is incomplete and didn't include the metabolic pathways other~     than hormonal or HER2 pathways.~      The metabolomics is an expanding field of research exploring the metabolites in cells,~     tissues or biologics fluids. It allows assessing the variation activation of the different~     cellular metabolic pathways. In oncology, it could highlight the main metabolic disturbances,~     the interaction of tumor cells and to identify the metabolic pathways involved in oncogenesis~     using the tumor cells metabolites profiles.~      Compared to genomic, the metabolomics integrated the impact of the cells environments on the~     cells biology. The cells environment plays, in fact, a key role in the oncogenesis and in the~     tumor cells phenotypes. The metabolomics, thus being a complementary approach of the genomic~     in order to assess a better knowledge of the impact of the extracellular environment on the~     tumor cell phenotype. In addition, the metabolomics analyses are fast and not expensive~     compatible with routine practice.~      The main objective of this study is to highlight a metabolic alteration specific to certain~     tumors phenotypes in order to have better understanding of the biology of the numerous breast~     cancer entities and find some biomarkers which could be some possible therapeutic target.~     Using a high resolution mass spectrometer, the investigators will analyze 52 tumor samples~     from frozen breast surgical specimen preserved in the Centre Antoine lacassagne tumor bank.~     The tissue analysis could be associated with a serum sample analysis from the frozen serum~     bank of the Centre Antoine Lacassagne. With 30 patients who performed a 18 FDG-PET before the~     surgery, The investigators will analyzed the correlation between the tumoral activation of~     the glycolysis pathways, quantified with mass spectroscopy and the 18FDG uptake. Using the 17~     frozen serums available, the investigators will perform a screening to identify some~     metabolites or metabolites profile which could be detected in the serum in order to develop a~     new liquid biopsy approach. This study is a retrospective study based on data and sample~     already available in the center and collected during the routine practice.~   "
15258|NCT03367195|"~     This is a 2-arm, prospective, double-blind double-dummy, randomized-controlled study~     comparing DLBS2411 at a dose of 250 mg twice daily with omeprazole at a dose of 20 mg twice~     daily, given before morning and evening meals, for an 8-week course of therapy. Subjects~     should avoid taking meals 2-3 hours before bedtime.~      The bioactive fraction of DLBS2411 has been proved at cellular and genetic levels to have an~     antiulcer effect through both suppressing the gastric acidity and enhancing gastric mucosal~     protection. The anti-secretory effect of DLBS2411 is exerted through the inhibition of H+/K+~     ATPase 'pump' as well as down-regulation of the H+/K+ ATPase gene expression, thus~     suppressing gastric acid secretion; while its cytoprotective defense mechanism works through~     the promotion of cyclooxygenase-2 (COX-2) derived prostaglandin (PgE2) synthesis, thus~     promoting gastrointestinal submucosal blood-flow, stimulating secretion of gastric-epithelial~     mucous and bicarbonate; anti-oxidative activity; and endothelial-nitric oxide (NO) formation.~      Recent study of DLBS2411 which was conducted in healthy volunteers, demonstrated the~     effective role and safety of DLBS2411 in suppressing intragastric acidity. Having such~     mechanisms of action, DLBS2411 is hypothesized to benefit patients with gastric acid~     disorders such as in gastroesophageal reflux disease (GERD).~   "
15259|NCT03367182|"~     This study will evaluate the efficacy and safety profile, response rate, progression free~     survival, overall survival of bevacizumab (Avastin) added to chemotherapy in patients with~     epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma with~     disease progression within 6 months of platinum treatment.~   "
15260|NCT03367169|"~     The assessment consists in comparing the osteosynthesis plate with minimally invasive~     technique versus open reduction and internal fixation.~      The aim of study is to compare (period of bandage, efficacy, safety), these two types of~     surgical technique by using a prospective, randomized analysis.~   "
15261|NCT03367156|"~     The goal of this clinical research study is to learn if dexamethasone can help to control~     dyspnea (shortness of breath) in cancer patients. Researchers also want to learn if it can~     help to improve lung function and quality of life. In this study, dexamethasone will be~     compared to a placebo.~      A placebo is not a drug. It looks like the study drug but is not designed to treat any~     disease or illness. It is designed to be compared with a study drug to learn if the study~     drug has any real effect.~      This is an investigational study. Dexamethasone is FDA approved and commercially available~     for the treatment of pain, nausea and tiredness. Its use to manage shortness of breath is~     investigational.~      The study doctor can explain how the study drug is designed to work.~      Up to 201 participants will be enrolled in this study. All will take part at MD Anderson and~     The Harris Health System (LBJ).~      Study assessments will be conducted in person or by phone during the course of this study.~      The study medication may be mailed to you.~   "
15262|NCT03367143|"~     This study is to evaluate the efficacy and safety of Lenalidomide plus ICE in the treatment~     of Refractory and Relapsed DLBCL patients.~   "
15276|NCT03366961|"~     This study aims to identify the safety and the survival benefit of the conversion surgery in~     stage IV or unresectable gastric cancer. The study designed single-arm phase II trial. All~     the patients would undergo curative-intent radical gastrectomy after palliative chemotherapy~     if the tumor responded to the chemotherapy. Primary endpoint was three-year overall survival.~     Secondary endpoints included short-term postoperative outcomes within 30 days, three-year~     relapse free survival, and success rate of conversion surgery (rate of R0 resection).~   "
15332|NCT03366233|"~     To assess the changes in brain activation and cerebral blood flow due to mental fatigue in a~     placebo-controlled study. More specifically we want to assess whether brain activation~     [measured with Blood Oxygen Level Dependent (BOLD) functional resonance imaging (fMRI)] is~     decreased during a Flanker task in a mentally fatigued state and whether this coincides with~     a decline in cognitive performance. In addition we also want to evaluate whether cerebral~     blood flow [measured with arterial spin labeled (ASL) fMRI] in a resting state is reduced~     when mentally fatigued.~   "
15263|NCT03367130|"~     Antiretroviral therapy (ART) has been a game changer in the context of HIV-epidemic. From~     2005 to 2015, HIV-related deaths have fallen by 45% thanks to ART. However, ART's success~     heavily depends on HIV-positive individuals' high adherence to it. This includes clinic~     attendance for various purposes. It is necessary among HIV-positive individuals for their~     antiretroviral (ARV) pills pick up, monitoring of their treatment outcomes, and treatment of~     their opportunistic infections. Among them, ARV pills pick up is the major reason for the ART~     clinic attendance. Improving clinic attendance for pills pick up remains one of the key~     challenges to ART programs. The World Health Organization (WHO) recommends more than 90%~     on-time ARV pills pick up as per the early warning indicators of HIV-drug resistance. Among~     six Asian countries, none of the 1048 clinics under the study could meet the WHO target.~     Among HIV-positive individuals, clinic attendance for pills pick can be improved by using~     mobile phones. Those who receive mobile phone reminders are two times more likely to attend~     their clinics regularly than those who did not receive such reminders. Nepal belongs to a~     low-income country and is facing a similar problem, too. In 2015, approximately 39,000 people~     were estimated to be living with HIV and ART coverage was limited to only 31.5%. In the same~     year, only 32% of the HIV-positive individuals attended their clinics regularly for ARV pills~     pick up. Like other countries, one of the potential strategies is to use mobile phones~     effectively in Nepal. Mobile phones have been very widely used in Nepal. In 2016, Nepal had~     27.9 million mobile phone users, against the population of 26.5 million. Under such a~     context, mobile phone reminders can be effective to improve clinic attendance among~     HIV-positive individuals. However, the effectiveness of such interventions barely remains~     examined by using a randomized controlled trial. This study evaluates the effectiveness of~     mobile phone reminder intervention on improving clinic attendance for ARV pills pick up and~     medication adherence among HIV-positive individuals on ART following the implementation of~     test and treat strategy in Nepal.~   "
15264|NCT03367117|"~     Investigator therefore propose a retrospective mono-centric study, to compare the results~     obtained in patients with myeloma or lymphoma, mobilized with Zarzio® in order to obtain a~     graft, with the results obtained in our study. retrospective cohort of mobilization by~     Granocyte®.~   "
15265|NCT03367104|"~     The purpose of this study is to quantitate electrical dyssynchrony in heart failure (HF)~     patients with a narrow QRS complexes (≤ 130 ms) using the ECG Belt. This is a pilot study~     that is designed to provide data that can be used in designing and implementing a prospective~     study of cardiac resynchronization therapy (CRT) in narrow QRS patients selected and~     optimized using the ECG Belt.~   "
15266|NCT03367091|"~     To investigate acute metabolic and cardiorespiratory responses during overground gait~     training with a wearable exoskeleton in persons after stroke~   "
15267|NCT03367078|"~     The present observational study is aimed at reporting the short-, mid- and long-term outcomes~     of patients with Disorder of Consciousness (DOC), in Vegetative State (VS) or Minimally~     Conscious State (MCS), due to a severe Acquired Brain Injury (sABI), after repeated~     treatments with anodal Transcranial Direct Current Stimulation (tDCS) on Left Dorsolateral~     Prefrontal Cortex (L-DLPFC), to stimulate recovery of consciousness. The results obtained~     will also be compared with those of a historical control cohort, before the introduction of~     tDCS, matched for demographic and clinical characteristics.~   "
15268|NCT03367065|"~     This feasibility study has therefore several aims:~        1. construct a dedicated CT perfusion protocol for GIT wall perfusion;~        2. used a two-compartment pharmacokinetic model which is more adapted that a unique~          compartment model;~        3. from the image acquired, evaluate current parameters of perfusion including the~          permeability ones~   "
15269|NCT03367052|"~     The objective of this study is to investigate the clinical and radiological results of~     two-level cervical ProDisc-C vivo versus hybrid construct.~   "
15270|NCT03367039|"~     The object of this study is to assess the long-term safety and efficacy of cervical disc~     replacement with the ProDisc-C vivo Cervical Disc in a prospective, randomized, multi-center~     trial with 7 years of follow-up.~   "
15271|NCT03367026|"~     REHSI is a prospective, multi-center, open label, randomized, controlled two arms, to~     evaluate the ability of ivabradine to reduce an elevated heart rate in septic shock patients.~     The primary end point is the reduction of heart rate within 24 hours. This trial will~     randomize 70 patients (men and women, aged ≥ 18 years) with newly diagnosed Septic Shock~     (despite adequate fluid resuscitation, were still requiring high-dose norepinephrine (NE) to~     maintain a mean arterial pressure (MAP) ≥65 mmHg , and had a tachycardia >100 beats per~     minute (bpm). Treatment period will last 4 days. All patients will be followed for up to six~     months.~   "
15272|NCT03367013|"~     This is a multicentre, phase III, 2-arm, masked randomized controlled trial. The primary~     hypothesis is that oral bovine lactoferrin (bLF), through its antimicrobial, antioxidant and~     anti-inflammatory properties, will reduce the rate of mortality or major morbidity in very~     low birth weight (VLBW) preterm infants.~   "
15273|NCT03367000|"~     The dialysis population has a strikingly high incidence of mortality. The life expectancy of~     chronic dialysis patients is 20 years less than that of the general population. Approximately~     50% of individuals with end stage renal disease (ESRD) die from a cardiovascular (CV) cause~     with mortality being 15 to 30 times higher than the age-adjusted CV mortality in the general~     population. There is also a steady increase of patients with diabetes and the older age~     groups coming into dialysis. The treatment of patients with ESRD aims at prolonging life,~     achieving good nutritional status and promoting the best possible functioning and quality of~     life (QOL). Several factors that are beyond adequacy of dialysis predict high mortality in~     ESRD patients. Associated co-morbidities and malnutrition factors are independently~     associated and the combined presence of both malnutrition and co-morbidities manifest the~     worst survival.Therefore this study investigates the efficacy of protein supplementation in~     improving health status and quality of life among peritoneal dialysis (PD) patients. This~     research will also generate basic data about significant health markers critical to the~     health status of PD patients.~   "
15274|NCT03366987|"~     Atrial fibrillation and nonalcoholic fatty liver disease are two pathological conditions that~     are highly prevalent worldwide and share multiple CVD risk factors. There is rare research~     performed among elderly adults. The investigators are conducting a cross-sectional analysis~     of elderly adults (≥65 years) to investigate the association between atrial fibrillation and~     nonalcoholic fatty liver disease in an elderly Chinese population.~   "
15275|NCT03366974|"~     The study objective is to evaluate and validate of endogenous markers for the assessment of~     change in CYP3A activity by route of administration in Korean healthy subjects using~     metabolomics. In addition, we aim to screen novel endogenous marker, which could determine~     the total or intestinal CYP activity.~   "
15318|NCT03366415|"~     The purpose of this study is to compare the efficacy and safety of sequential~     chemoradiotherapy (induction chemotherapy + intensity-modulated radiotherapy +adjuvant~     chemotherapy) with induction chemotherapy plus concurrent chemoradiotherapy in patients with~     locoregionally advanced nasopharyngeal carcinoma (NPC), in order to confirm the value of~     sequential chemoradiotherapy in NPC patients.~   "
15277|NCT03366948|"~     The fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)~     recently identified Internet gaming disorder as a new potential psychiatric disorder which~     need further research. Several studies showed the important prevalence of psychiatric~     disorders among patients suffering from internet gaming disorder. Investigators hypothesize~     that on an other side the prevalence of internet gaming disorder among patients suffering~     from psychiatric disorders shall be high but it has never been studied yet.~      The main goal of this trial is to examine the prevalence of internet gaming disorder using~     the Internet Gaming Disorder Test-10 (IGDT-10) among inpatient aged from 12 to 17 of 4~     psychiatric units of French region Auvergne-Rhône-Alpes.~      Secondary goals will be to assess a parental version of the IGDT-10 (IGDT-10-P) and to~     compare the two versions.~      IGDT-10 will be passed during 6 months to every inpatient and IGDT-10-P to their parents~     within the 21 first days of the hospitalisation.~   "
15278|NCT03366935|"~     This study intends to carry out a prospective, randomized double-blind study to evaluate the~     safety and efficacy of the combined implementation of Dural puncture epidural (DPE) technique~     and Programmed intermittent epidural bolus (PIEB) for labor analgesia.~   "
15279|NCT03366922|"~     Introduction Artemisia annua L is a medicinal plant traditionally used for treatment of~     malaria and other diseases in China. The extract of leaves of the plant has been demonstrated~     in-vitro to have potent anti HIV effects and in vivo to improve levels of lymphocytes in~     laboratory animals. Effect on lymphocyte stimulation has also been observed in non HIV~     persons taking the leaves of the plant as a tea for malaria prophylaxis in Uganda.~      Objective To determine the effect of A.annua L and Moringa oleifera leaf powder on CD4 cell~     count and other immunological indices in HAART HIV patients.~      Materials and Methods In this study Artemisia annua leaf powder and Moringa leaf powder will~     be investigated. The study will be a three arm randomized Phase II study involving adult~     patients with HIV-infection on HAART with CD4 below 350. The CD4 cell count, and other~     immunological indices in patients receiving HAART will be compared with those patients~     receiving additionally Artemisia annua powder with Moringa oleifera powder or Artemisia annua~     powder alone. The study will be conducted at the HIV clinic in Mbarara Regional Referral~     Hospital while laboratory tests will be done at Mbarara University of Science and Technology~     clinical and pharmaceutical sciences laboratories.~      Expected outcome The primary outcome will be change in mean (Median) CD 4 cell count.~     Secondary outcomes will be mean (or median) changes, viral load, complete blood count and~     other HIV associated immunological indices , Performance status and incidence of adverse~     effects like nausea, diarrhoea, weight gain and or loss.~      Expected benefits Adequate immunological recovery is one of the desired outcomes in HIV care.~     HAART combinations do not directly aid immunological recovery and some patients fail to have~     adequate immunological recovery despite adequate suppression of viral load. There are many~     patients using herbal supplements but there is limited scientific clinical evidence on the~     benefit of these supplements in HAART patients.~   "
15280|NCT03366909|"~     Cannabis use can lead to addiction in about 5 to 10 % of users in France. Currently,~     behavioral interventions are the most dependable but effectiveness is still reduced.~     Mindfulness meditation has demonstrated an effectiveness in several meta analysis (anxiety~     and depressive disorder) and seems to be relevant to reduce anxious and impulsive symptoms~     found in cannabis use disorders.~      This study proposes to determinate the mindfulness effectiveness in reduction of cannabis use~     in regular consumer. The consumption decrease is estimated with a retrospective diary, TLFB~     (Timeline Follow Back) which collect cannabis use every week until the 12th. Urine (week~     0/baseline, 2, 4, 6, 8, 10, 12) and hair (week 0/baseline, 10) analyses are regularly~     effected.~      Patients included in control group get classic cares in an addictology center in CHRU of~     Nancy. Patients included in mindfulness group receive one session a week during eight weeks~     (MBRP protocol : Mindfulness -Based Relapse Prevention). The study process goes on for 12~     weeks.~      An ancillary study measures the impact of cannabis decreases on retinal electrophysiological~     and architectural markers, usually disturbed by cannabis uses.~   "
15281|NCT03366896|"~     Validation of the Malay version of 3D-CAM, involving two-staged process.~        1. Translation and cultural adaptation of 3D-CAM into the Malay language.~        2. Testing for Validity and Reliability of the translated 3D-CAM tool to detect~          postoperative delirium.~   "
15282|NCT03366883|"~     This is a Phase III clinical trail which Comparing Paclitaxel, Cisplatin Plus 5-FU (TCF)~     Versus Radiotherapy with Paclitaxel Plus Cisplatin (TC-RT) as Preoperative Therapy for~     Locally Advanced Esophageal Squamous Cancer. The Preoperative chemoradiotherapy with radical~     surgery is the standard treatment in China. But, many patients do not receive this treatment~     for many other reasons. Most of them refused or abandon radiotherapy because of the~     Intolerable adverse effects of radiotherapy, so we have launched a randomized controlled~     trial to confirm the non-inferiority of TCF over chemoradiotherapy with TC (TC-RT) as~     preoperative therapy for locally advanced esophageal squamous cancer in overall survival.~   "
15283|NCT03366870|"~     Insomnia is major problem among Operation Enduring Freedom (OEF), Operation Iraqi Freedom~     (OIF), and Operation New Dawn (OND) Veterans. Insomnia impacts physical and mental health~     functioning and is associated with reduced quality of life. Cognitive Behavioral Therapy for~     Insomnia (CBT-I) is one of the most promising treatments for insomnia; however, access to~     CBT-I is severely limited by a lack of trained clinicians within the Veterans Health~     Administration (VHA) and Department of Defense (DoD). There is a critical need to offer~     innovative approaches to meet the demand and need for insomnia treatment. Leveraging~     technology to meet treatment demands is consistent with service delivery models based upon~     stepped care principles. This randomized controlled trial will determine whether a~     computerized, self-guided, web-based version of CBT-I is efficacious in reducing insomnia~     symptoms and improving functioning compared to a computerized program control.~   "
15284|NCT03366857|"~     The effect of supplemental oxygen on surgical site infections was already investigated in~     several studies before. Although, oxygen is one of the most used medical therapy in~     hospitalized patients, the influence on the cardiovascular system is still unknown. Available~     data indicate beneficial effects of supplemental oxygen on cardiovascular function. Because,~     no evidence exists concerning the perioperative period, it is our objective to investigate~     supplemental oxygen in cardiac risk patients undergoing major abdominal surgery. Due to the~     significant reduction of BNP by inhibiting sympathetic nerve activity we hypothesize that~     supplemental oxygen have beneficial effects in perioperative BNP release in cardiac risk~     patients undergoing major abdominal surgery.~   "
15319|NCT03366402|"~     This study designed to examine changes of immune system cells sub-populations during~     influenza disease. Several parameters will be examined, such as: amount of sub populations,~     clinical parameters (body temperature and number of hospitalization days).~      The participants are children that are hospitalized in the Laniado hospital pediatric~     department.~   "
15333|NCT03366220|"~     There is a knowledge gap regarding the optimal initial fluid to achieve effective~     resuscitation and improved outcomes in septic shock. The purpose of this study is to compare~     initial resuscitation with plasma to initial resuscitation with balanced crystalloids.~   "
15285|NCT03366844|"~     This study is being done to assess the safety and tolerability of pembrolizumab (study drug)~     combined with standard radiation to the tumor (tumor boost) before patients undergo standard~     treatment that can consist of one or more of the following: breast-conserving surgery,~     radiation to the entire breast/chest wall after surgery, and chemotherapy.~      Study participants will receive two doses of the study drug intravenously (through the vein)~     before their planned breast surgery or chemotherapy. The study drug will be administered~     three weeks apart. At the time of the second dose, radiation to the tumor in the affected~     breast will be given. This type of radiation treatment is called a tumor boost, which is a~     standard part of radiation therapy for breast cancer that may occur either before or after~     planned breast-conserving surgery. Patients will receive breast surgery or begin chemotherapy~     approximately six weeks after your first dose of the study drug.~   "
15286|NCT03366831|"~     The purpose of the proposed research is to perform testing of the Thirty Million Words~     Newborn Initiative (TMW-NI) with the primary goal of evaluating various implementation~     methods.~      The investigators hypothesize that the TMW-Newborn intervention will:~        1. Significantly impact parent knowledge regarding the importance of UNHS follow-up~        2. Significantly impact parent knowledge of child development~           Additionally,the investigators hypothesize that:~        3. The 7-minute version of the video with questions interspersed will most significantly~          improve parent knowledge of child development~        4. There will be no significant differences in effectiveness of the Spanish and English~          versions of the TMW-Newborn intervention~      The hypotheses rely on the existing research data supporting the idea that parental~     understanding and beliefs will alter parental behavior, and consequently, that increased~     parental linguistic input will impact child cognitive development.~   "
15287|NCT03366818|"~     To confirm efficacy and safety of VERSI system for acute ischemic stroke~   "
15288|NCT03366805|"~     Adult patients undergoing elective outpatient, upper extremity, orthopedic surgeries will be~     randomized to view one of two educational programs: 1) a 2-video series regarding~     post-operative pain management or 2) a video regarding wound care and activity. The effect of~     this educational program on pain medications used, pain control efficacy, and other measures~     of satisfaction and recovery will be assessed.~   "
15289|NCT03366792|"~     The purpose of this study is to investigate a transperineal biopsy approach (outside of the~     rectum) using MRI targeting to facilitate better access to the whole prostate gland and~     provide limited risk of infectious complications after biopsy.~   "
15290|NCT03366779|"~     This study is a prospective, multi-center study to monitor the early safety and performance~     of one iteration of the Barricaid Anular Closure Device (ACD) - 6mm anchor width, when used~     as an adjunct to limited discectomy.~   "
15291|NCT03366766|"~     This phase II trial studies how well Nivolumab, Cisplatin, and Pemetrexed Disodium or~     Gemcitabine Hydrochloride in treating patients with stage I-IIIA non-small cell lung cancer~     that can be removed by surgery. Monoclonal antibodies, such as Nivolumab, may interfere with~     the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as Cisplatin~     and Pemetrexed Disodium or Gemcitabine Hydrochloride, work in different ways to stop the~     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Giving Nivolumab, Cisplatin, and Pemetrexed Disodium or~     Gemcitabine Hydrochloride may work better in treating patients with non-small cell lung~     cancer.~   "
15292|NCT03366753|"~     Acute normovolemic hemodilution (ANH) has long been employed for reducing allogenic blood~     transfusion for cardiac surgery, and hydroxyethyl starch has been used as an intravenous~     replacement fluid during ANH procedure. However, possible impact of ANH employing HES on~     blood viscosity and oxygen delivery have not been well investigated in patients undergoing~     off-pump coronary artery bypass (OPCAB) surgery .~      Anesthesia is induced and maintained by using propofol-remifentanil-rocuronium in OPCAB~     surgery (n=21). ANH is performed by using 5 ml/kg of blood salvage and administering 5 ml/kg~     of balanced HES 130/0.42 (Tetraspan™) for 15 min during vascular graft harvesting. For the~     present study, three arterial blood samples (3 ml each) are taken before (Sample 1) and after~     ANH (sample 2 and 3) and they are stored in 3 tubes. Sample 3 (in tube) undergoes further 30%~     in-vitro dilution by adding 1-1.5 ml HES. By using a scanning capillary tube viscometer~     (Hemovister™), Blood viscosity at low shear rate (5/sec) of the three samples are determined.~     By using a formula with blood viscosity and hematocrit, tissue O2 delivery index (TODI, =~     hematocrit/viscosity at 5/sec) is calculated.~   "
15293|NCT03366740|"~     Diarrhea is the 2nd leading cause of death in under-five children. When diarrhea continued~     for 14 days or more it is known as Persistent Diarrhea (PD). In low and middle income~     countries (LMIC), 3%-23% of acute diarrheal episodes turn to PD. PD causes 32-62% of all~     diarrheal deaths in LMIC, and >25% in Bangladesh in contrast to 0.8% is caused by acute~     diarrhea. The prevalence of PD varied from 6.3 to 16.4 %. However, no larger prospective~     study was conducted to evaluate the efficacy of green banana in the management of PD among~     children older than 6 months.An open-labeled randomized controlled clinical trial is designed~     to assess the efficacy of green banana mixed full strength rice suji, and full strength rice~     suji alone compared to 3/4th strength rice suji in the management of persistent diarrhea (PD)~     in children aged > 6 months to 36 months in the Dhaka Hospital of icddr,b.~   "
15294|NCT03366727|"~     For years, first-line treatment of AVFs stenoses has been percutaneous transluminal~     angioplasty. However, restenosis and reintervention rates remain incredibly high and occur,~     according to recent studies, in up to 60% and 70% of patients at 6 and 12 months,~     respectively. Drug-coated balloons delivering paclitaxel at the angioplasty site have proved~     their superiority in the treatment of coronary and peripheral arterial stenoses. Paclitaxel~     reduces neointimal hyperplasia and drug-coated balloons,therefore, it represents an~     attractive option for AVF stenoses. This trial is aimed to evaluate the safety and efficacy~     of DCB in treating AVF stenosis in chinese population.~   "
15320|NCT03366389|"~     In this observational case-control study investigators aimed to assess the serum levels of~     adipokines such as Apelin, Chemerin and adiponectin in patients with irritable bowel syndrome~     (IBS), and compare it with healthy controls. Furthermore, investigators evaluated the~     possible correlation of these adipokines with IBS-QoL, IBSSS, GI symptoms and other clinical~     and psychological disorders.~   "
15334|NCT03366207|"~     This is a prospective, Phase 4, open label, multi-center study of the clinical and~     microbiologic efficacy of ciprofloxacin for the treatment of uncomplicated urinary tract~     infections in adult women.~   "
15295|NCT03366714|"~     Noninvasive ventilation defines methods of providing ventilation support with constant or~     variable pressure using nasal or nasopharyngeal interfaces without endotracheal intubation or~     tracheostomy. Today, short binasal prongs and different types of nasal masks are the most~     commonly used nasal interfaces in the NICU with the aim of providing NIV.~      RAM cannula (Neotech ™, Valencia, CA), a new nasal interface, is increasingly used in NID~     applications in newborn infants. The RAM cannula is available in the inspiration and~     expiration arms of the stroke while reducing the dead space in the respiratory tract due to~     the low nasal prong diameter. There are not enough studies comparing the effectiveness of the~     RAM cannula with other short binasal prongs or nasal masks.~      Investigators compared the effectiveness and nasal injury rates of RAM cannula and short~     binasal prong as NIV interfaces in preterm infants.~   "
15296|NCT03366701|"~     The principal aim of these researches is to explored the role of motivational parameters,~     including: automatic and controlled psychological processes and self-regulatory capacities,~     in physical activity and sedentary behaviors adoption and maintenance. Precisely~     investigators are interested in change in motivational and self-regulatory processes during~     rehabilitation programs and their prospective influences on self-reported and objective~     behaviors among persons with chronic diseases.~   "
15297|NCT03366688|"~     IBI306 is a fully human monoclonal antibody that binds proprotein convertase~     substilisin/kexin type 9 (PCSK9), preventing its interaction with the low-density lipoprotein~     cholesterol receptor (LDL-R) and thereby restoring LDL-R recycling and low-density~     lipoprotein cholesterol（LDL-C）uptake. This is a randomized, double-blind,~     placebo-controlled,single ascending dose study to evaluate the safety, tolerability,~     pharmacokinetics/pharmacodynamics and immunogenicity of IBI306 in healthy adults.~   "
15298|NCT03366675|"~     This study is a single arm, multi-center phase II study of AZD 2811 monotherapy in patients~     with relapsed small cell lung cancer (SCLC) as a second or third line therapy.~      Patients will continue to receive study treatment as described above, until they demonstrate~     objective disease progression (determined by RECIST 1.1) or they meet any other~     discontinuation criteria.~   "
15299|NCT03366662|"~     This study evaluates the effect of frontal EMG activity on Entropy index in burst suppression~     level of propofol anesthesia and surgery~   "
15300|NCT03366649|"~     The investigators are interested in determining the best surgical technique to correct~     functional mitral regurgitation, as there is currently not one technique that is established~     to work better than the other.~      The technique used in current clinical practice is undersizing mitral annuloplasty (UMA), in~     which a prosthetic ring is implanted onto the mitral valve to correct the leakage. Though~     widely adopted, durability of the repair is less, as 58% of the patients present with~     recurrent FMR within 2 years. There are no specific algorithms to predict who might have UMA~     failure, but research indicates that some geometric indices might be strong predictors. The~     investigators are interested in testing the hypothesis that, elevated lateral inter-papillary~     muscle separation (IPMS) is a predictor of post-UMA recurrence of FMR at 12 months. In the~     first part of this study, the study team will measure lateral IPMS before surgery, and relate~     to post-surgery FMR severity at discharge/30 days, 6 months and 12 months.~      A relatively newer technique is papillary muscle approximation (PMA), in which a suture draws~     together the two muscles that connect the mitral valve to the heart muscle prior to~     performing UMA. This reduces the lateral inter-papillary muscle separation (IPMS) and is~     expected to improve the durability of UMA. In the second part of this study, the~     investigators will perform PMA and UMA together and determine if FMR severity is reduced at~     discharge/30 days, 6 months and 12 months.~   "
15301|NCT03366636|"~     This study will design and rigorously evaluate the efficacy of Project Legacy, a five week~     positive youth development intervention to decrease sexual risk for unintended pregnancies~     and STIs among youth experiencing homelessness or at risk of homelessness aged 14-19. This~     randomized control trial will compare Project Legacy to a usual services control.~   "
15302|NCT03366623|"~     This study evaluates the effect of an intervention with a hospital clown compared to standard~     care on pain experience for acute hospitalized children receiving venipuncture. Half of the~     children will receive an intervention with the hospital clown while the other half will~     receive standard care.~   "
15303|NCT03366610|"~     The purpose of this study is to assess long-term outcomes in subjects previously treated with~     daclatasvir-based therapy for chronic Hepatitis-C (CHC)~   "
15304|NCT03366597|"~     To observe the effect of sevoflurane on the concentration of S100β and regional cerebral~     oxygen saturation in infants with congenital heart disease undergoing cardiac surgery.~   "
15305|NCT03366584|"~     Hyaline membrane disease, now commonly called respiratory distress syndrome (RDS), and~     feeding intolerance, which can lead to necrotizing enterocolitis (NEC), are two key~     morbidities found in premature neonates which resulted in high mortality rate in Indonesia.~     Cochrane meta-analysis proved that antenatal steroid therapy can reduce the morbidity and~     mortality rate of premature neonates. But there is still different outcomes and severity of~     disease in preterm newborn receiving the same dose of antenatal steroid therapy. This raises~     questions whether there are other factors influencing the development and maturity of lung~     and gut in preterm newborn, aside from steroid therapy. Vitamin A, D and zinc are already~     known for their function in fetal lung and gut development. To our best of knowledge, no~     study has evaluated the effect of these vitamins levels on HMD and feeding intolerance in~     premature neonates. Therefore, the aim of this study want to evaluate the effect of antenatal~     steroid therapy versus co-administered β-carotene, vitamin D3, zinc and antenatal steroid~     therapy on the presence and severity of HMD and feeding intolerance in premature neonates.~   "
15306|NCT03366571|"~     Patients who have completed 3 years follow-up of the past Beijing Science and Technology~     Commission Research will receive another 2-years anti-viral therapy. Patients will be~     assessed at baseline and every six months for blood cell count, liver function test, HBVDNA,~     AFP, prothrombin time, liver ultrasonography, and Fibroscan. CT or MRI and endoscopy will be~     performed at baseline and 3 years. At the end of the study, the cumulative rate of clinical~     hepatic hard endpoint will be calculated.~   "
15914|NCT03358628|"~     By obtaining clinical specimens from participants with high-grade bone and soft tissue~     sarcomas to establish and profile as freshly implanted tumors in mice, the aim of this study~     is to identify agents with predicted activity in the host patient while also potentially~     providing them with individualized cancer treatment options~   "
15307|NCT03366558|"~     Parkinson's disease (PD) is a chronic and progressive neurological movement disorder, meaning~     that symptoms continue and worsen over time. Nearly 10 million people worldwide are living~     with Parkinson's disease. Finding cost-effective non-invasive monitoring techniques for~     detecting motor symptoms caused by Parkinson's disease are potentially of significant value~     for improving care. Of the PD symptoms, the motor symptoms are the most common and detectable~     signs that can be assessed unobtrusively for both diagnosis and for evaluating the~     effectiveness of the treatments.~      The goal of our study is to find methods for identifying and classifying the motor symptoms~     caused by Parkinson's disease. Focus of the study is on long-term motion tracking~     measurements conducted at home during normal everyday life. Both accelerometers connected to~     arm and leg and mobile phone inbuilt sensors carried in the belt are utilized in the study.~     The research has two main objectives / hypotheses:~        1. Can the motor symptoms related to different levels of Parkinson's disease be identified~          using motion tracking sensors? The first objective includes extracting and screening the~          motion differences of patients in early stages of the diseases in comparison with the~          patients in developed stages (patients having hypokinesia, dyskinesia and state changes)~          of the diseases and their differences with healthy control elderly adults using advanced~          signal and data analytics. Data from questionnaires and walking test conducted in the~          hospital environment are utilized as comparison points. Goal is to test the hypothesis~          that the amount of motor symptoms can be detected and the three groups can be reliably~          separated using sensor data.~        2. Can the time when the Parkinson medicine is taken be detected from the movement signals?~      A sample of 50 volunteer PD patients with early stage of the disease (no dyskinesia and state~     changes), plus 50 volunteer PD patients in the later stage of the disease (having dyskinesia~     and state changes), plus 50 volunteers who do not have Parkinson's disease will be recruited~     for the research.~      Study starts with a telephone screening and visit to the hospital. Background characteristics~     and stage of the Parkinson's disease is evaluated in the hospital using a UPDRS~     questionnaires (Unified Parkinson's Disease Rating Scale; Finnish version) and a standardized~     20-step walking test. Before the walking test, accelerometer sensors are attached to the~     shank and on the nondominant wrist. In addition, the participant wears a smart mobile phone~     with embedded accelerometer and gyroscope sensors. Based on the questionnaires and walking~     test study physiotherapist classifies the participant into one of the three study groups.~      The major part of the study involves a 3-day motion screening in a free-living setting in~     which the subjects are wearing the abovementioned sensors for as long duration as they~     comfortably can and are willing. This 3-day study starts immediately after completion of the~     20-step walking test in the hospital. During the 3-day study, subjects are free to live their~     lives without any additional tests. Subjects mark down the time when they take their~     Parkinson medication.~   "
15308|NCT03366545|"~     The registry is primarily designed to assess outcome, efficacy and residual safety aspects of~     CRT based on long-term data from an unselected, real-life clinical set-up. Moreover, the~     observation of the patient status should help to find possible predictors for HF events and~     to identify areas of improvement for CRT and for CRT device settings.~   "
15309|NCT03366532|"~     To determine the relationships of a variety of nutrients, foods, and dietary patterns with~     the subsequent risk of developing type 2 diabetes, cardiovascular disease, and mortality in~     US men and women.~   "
15310|NCT03366519|"~     Pulmonary Embolism (PE) is a frequent disease, the third cause of cardiovascular death after~     stroke and myocardial infarction. According to European guidelines of European Society of~     Cardiology (ESC) and of European Respiratory Society (ERS), the prognostic stratification of~     PE severity is mandatory as soon as PE is diagnosed. This stratification includes the~     hemodynamic status, and specific tools : the assessment of the sPESI score, and the~     evaluation of PE's impact on right ventricle (RV) : increased biomarkers (troponin, BNP) and~     right ventricle/left ventricle (RV/LV) ratio.~      the RV/LV ration may be evaluated ideally by transthoracic echo (TTE), or by CT scan.~     Unfortunately, only 10% of patients with PE are evaluated with TTE by a cardiologist in the~     initial time of PE diagnosis. Hence, the CT scan is the most frequent way to assess RV/LV~     ratio. However, CT is not possible for all patients (patients with contra-indication) or may~     have difficulties to provide a clear assessment because of technical issues.~      Then, there is a need for morphological evaluation of RV as soon as PE is diagnosed, in every~     clinical setting. The improvement in technologies allowed the development of clinical~     echography (CE) in emergency departments.~      CE is already available, non-invasive, less expansive, and may be a good way to assess RV/LV~     ratio in patients with PE diagnosed in emergency departments.~      The investigators propose a prospective, multicenter study to assess the sensitivity of CE in~     patients with PE, compared to CT scan to detect RV/LV ≥0.9.~   "
15311|NCT03366506|"~     Investigation of the epidemiological factors associated with amyotrophic lateral sclerosis~     (ALS) in Israel with a view to future international collaboration. Particularly addressing:-~        1. Differences between ethnic subgroups~        2. Differences between immigrant and native-born populations~        3. Differences according to military service profile Clinical features gathered at each~          routine visit ,throughout the entire course of the disease, will be recorded in database~          format, in order to correlate with potential epidemiological factors.~   "
15312|NCT03366493|"~     The FRDTM is easy to perform and does not require sophisticated laboratory technology and/or~     experienced pathologists for test result interpretation. Compared to the Pap smear and HPV~     test, the FRDTM enables clinicians to obtain test results immediately (within 60 seconds)~     after the screening. This empowers clinicians in making timely decisions on appropriate~     patient management, and facilitating patient compliance with follow-up procedures. In~     addition, the FRDTM requires minimal training and technical support. Due to its advantage of~     rapid visualization of abnormal cervical lesions (CIN2+) in a cost-effective way, health care~     professionals can make cervical cancer detection accessible to women worldwide, especially in~     regions with limited medical resources. This is a cross-sectional study to evaluate the~     clinical performance of Folate Receptor-Mediated Epithelium Staining (FRDTM) in detecting~     cervical neoplastic lesions (CIN2+).~   "
15313|NCT03366480|"~     A phase I/ II, open label study to assess the efficacy and safety of ABTL0812 in combination~     with paclitaxel and carboplatin in patients with advanced endometrial cancer or squamous~     NSCLC.~   "
15314|NCT03366467|"~     The objective of the present study is to determine the effect of sensory adapted dental~     environment (SADE) in healthy children during a routine dental restorative treatment. The~     hypothesis is that the SADE would have a favorable effect in calming the subjects during~     dental treatment.~      the study is a random cross-over design. The participants will be randomly assigned into two~     groups. Group 1 will initially be treated under SADE (Time 1) and receive regular dental~     environment (RDE) on the second encounter (Time 2). For the second group, the procedure is~     reversed (RDE at Time 1 and SADE at Time 2).~   "
15315|NCT03366454|"~     Participants who meet the inclusion and exclusion criteria will be enrolled and then having a~     daily follow up for maximum of 13 days' hospitalization. Next follow up will be taken time at~     day 14th after hospitalization date, either on ward or policlinic. The participations will be~     ended by day 30th after hospitalization date when the called follow up is done by~     investigator.~   "
15316|NCT03366441|"~     Blood donor retention is a critical strategy to ensure the safety and sufficiency of clinical~     blood supply. An effective strategy can prevent donors from lapsing and eventually becoming~     inactive.~   "
15317|NCT03366428|"~     This study will look at the effect of DS-8201a on heart rate and the movement of the drug~     through the body (pharmacokinetics) in participants with a certain type of breast cancer~     (HER2).~   "
15322|NCT03366363|"~     Knee osteoarthritis (KOA), also called degenerative knee disease, is one of the most common~     bone and joint diseases in clinic. It was estimated to affect more than 9 million individuals~     in the United States in 2005 and is a leading cause of disability and medical costs. Most~     elderly people over the age of 65 have radiographic and/or clinical evidence of~     osteoarthritis. KOA is a lifelong disease which can lead to obvious pain, joint stiffness,~     limitation of activity and even joint failure or disability. Acupuncture is a popular~     treatment taken from ancient Chinese medicine, in which fine needles are placed into the body~     at specific points. Studies have shown that acupuncture can stimulate nerves under the skin,~     causing the body to produce natural pain-relieving substances (endorphins). However the~     evidences of acupuncture for KOA are contradictory. According to the review, intensive~     acupuncture with three sessions a week is more effective for KOA than sparse acupuncture with~     one session a week. Moreover, the papers published in the past years suggest that manual~     acupuncture and electro-acupuncture are most commonly used acupuncture therapy for the~     treatment of knee osteoarthritis. The aim of this study is to evaluate the efficacy of~     intensive electro-acupuncture or manual acupuncture versus sham acupuncture in reducing pain~     and improving function in patients with KOA.~   "
15323|NCT03366350|"~     Anti-CD19 chimeric antigen receptor (CAR)-modified T cell therapy has been confirmed~     effective for relapsed/refractory B-cell malignancies. However, its ability to keep patients~     in maintained remission is limited. In order to extend the remission time, investigators~     transfer patients who obtain remission through CAR-T therapy to hematological stem cell~     therapy (HSCT). The study aims to evaluate the safety and effectiveness of CAR-T therapy~     bridging to HSCT.~   "
15324|NCT03366337|"~     This multi-center, open-label Phase 2 trial will study the safety, tolerability, and efficacy~     of bardoxolone methyl in qualified patients with the following rare chronic kidney diseases~     (CKD): CKD associated with type 1 diabetes (T1D), IgA nephropathy (IgAN), focal segmental~     glomerulosclerosis (FSGS), and autosomal dominant polycystic kidney disease (ADPKD). Patients~     will be enrolled in disease specific cohorts within the trial, and effectiveness of~     bardoxolone methyl in treating CKD will be assessed separately by cohort for each rare CKD.~      All patients in the study will follow the same visit and assessment schedule. Following~     randomization on Day 1, patients will be scheduled to be assessed during treatment at Weeks~     1, 2, 4, 6, 8, and 12, and by telephone contact on Days 3, 10, 21, 31, 38, and 45. Patients~     will also be scheduled to be assessed at an in-person follow-up visit at Week 16, four weeks~     after the end of treatment.~   "
15325|NCT03366324|"~     For micro residual disease (MRD) positive patients who have undergone at least 2 cycles~     chemotherapies for their CD19+ B-cell malignancies, there would be much more risks for them~     to receive hematological stem cell transplantation (HSCT) than MRD- patients. In order to~     reduce HSCT-related adverse events for these kind of patients, investigators plan to conduct~     CAR-T therapies on them first to make them achieve MRD- statuses, and then transfer them to~     HSCT.~   "
15326|NCT03366311|"~     To investigate which shapes of stylet, hand techniques and possible condition that improve~     intubation successful rate and reduce the elapsed intubation time.~   "
15327|NCT03366298|"~     Food allergy affects up to 2% of adults and 8% of children in the United Kingdom (UK), and is~     a major public health issue. It is the commonest cause of life-threatening allergic reactions~     (anaphylaxis), which can be fatal. Adrenaline (epinephrine) auto-injector (AAI) devices are~     the first-line treatment for anaphylaxis, yet in a UK survey, over 80% of 245 teenagers~     experiencing anaphylaxis did not use their AAI. Delays in, or lack of adrenaline~     (epinephrine) administration during anaphylaxis are risk factors for fatal anaphylaxis.~      In 2010, a coroner's investigation into the death of a food-allergic teenager in the UK~     raised several questions around AAI safety and efficacy, since the teenager died despite~     administering her auto-injector device. This prompted a review by the Medicines and~     Healthcare products Regulatory Agency (MHRA) in 2014 into the clinical and quality~     considerations of AAIs. Two recommendations which came from the review was that companies~     'should be encouraged to develop a 0.5mg [dose] AAI.' In the UK currently only Emerade, one~     of the three companies selling AAIs, manufactures a 0.5mg (500mcg) version. Emerade also has~     a longer needle length (23mm) compared to other AAIs (typically 15mm).~      The investigators plan to formally assess the pharmacokinetics (PK) and pharmacodynamics (PD)~     of self-injection with intramuscular adrenaline (epinephrine) in teenagers at risk of~     anaphylaxis due to food allergy, and have been prescribed AAI.~        1. The investigators will compare self-injection with 300mcg vs 500mcg in teenagers of body~          weight >40kg. In a 40kg person, an adrenaline dose of 300mcg results in an effective~          UNDER-dosing of 30% by body weight.~        2. The investigators will also assess the impact of needle length on injection, by~          comparing two different devices, both of which deliver 300mcg, but one via a 15mm needle~          and the other with a 23mm needle.~   "
15328|NCT03366285|"~     Recent research has identified differences in the quality of mother-child interaction and~     gene expression of six key molecules involved in stress response and neurobehavioral~     development in preterm infants (born <32 weeks of gestational age) with early skin to skin~     contact after birth compared to infants with visual contact at six months corrected age. We~     hypothesize that these differences are still identifiable at the age of 6 to 8 years and that~     quality of bonding in preterm infants born <32 weeks of gestation differs significantly from~     late preterm infants and full-term infants.~   "
15329|NCT03366272|"~     This study evaluates the addition of nivolumab to gemcitabine, oxaliplatin plus rituximab in~     case of B-cell lymphoma~   "
15330|NCT03366259|"~     The aim of our study is to assess the value of administration of prostaglandins before~     cesarean section to reduce the amount of blood loss~   "
15331|NCT03366246|"~     This is a study aimed at evaluating the efficacy of a topical anesthesia (test product)~     compared to placebo in adult patients of phototypes I to III, with indication of treatment of~     CO2 fractional laser in the forehead. In addition to efficacy, safety and tolerability of the~     product have been studied.~      The product under investigation is a topical formulation containing lidocaine 25 mg/g and~     prilocaine 25mg/g which in previous studies performed in the same institution with healthy~     subjects in adulthood showed faster onset than other formulations. In these previous studies,~     the product was well tolerated, and there were no signs of a skin reaction or adverse events~     of a systemic nature.~      The CO2 fractional laser treatment is routinely used by plastic surgery and dermatology for~     treatment with aesthetic purposes of skin imperfections. It's a procedure until certain~     painful point, which as a rule is performed without prior use of topical anesthetic.~      The test product is believed to produce a clinically significant reduction of pain when~     compared to placebo, during the application of CO2 laser on the forehead for the aesthetic~     treatment of the face.~   "
18021|NCT03331055|"~     This study evaluates the effect of percutaneous electrical nerve stimulation (PENS) and~     transcutaneous nerve stimulation (TENS) for pain relieving in patients with pancreatic~     cancer. Patients will randomly allocated into PENS group, Tens group and control group.~   "
15335|NCT03366181|"~     Failing heart negative remodeling alterations might provide electrical heterogeneity and~     cardiac remodeling, thus potentially contributing to the occurrence of ventricular arrhythmia~     and subsequent sudden cardiac death (SCD). In this study we have prospectively investigated~     whether serum markers of heart failure (ultra sensitive Troponin , B type Natriuretic Peptide~     (BNP), C reactive protein (CRP), and ST protein) could be used as predictors for the~     occurrence of malignant ventricular arrhythmias in patients who had received an Implantable~     Cardioverter Defibrillator (ICD) for primary prevention.~   "
15336|NCT03366168|"~     Background:~      Stem cells are found in body tissues. They can regenerate into more of the same cells or~     become other types of cell. Researchers want to use stem cells from taste buds to try to make~     cells that secrete insulin. Taste buds are found mostly on the tip and sides of the tongue.~     Researchers also want to study if the number of taste buds and stem cells decrease as people~     age. They will remove small pieces of tongue tissue (about the size of a pen tip). The taste~     buds will grow back. It is hoped that studying taste bud stem cells can lead to new diabetes~     treatments.~      Objectives:~      To see if stem cells from taste buds can be isolated in humans.~      Eligibility:~      Healthy adults at least 18 years old~      Design:~      Participants will be screened with:~        -  Medical history~        -  Physical exam~        -  Blood and urine tests~        -  Tongue photograph and mouth inspection. Food coloring will be applied to the tongue.~      Participants will have 1 study visit. They will not eat or drink anything 8 hours before.~        -  They will give blood and urine samples.~        -  They will have a tongue biopsy. Vital signs will be checked. The inside of the mouth~          will be examined. The tongue may be cleaned. The tongue will be numbed. Five small~          pieces of tissue will be taken with a small scissor. Any bleeding will be blotted with~          cotton and should stop in minutes.~        -  Participants will be monitored for about 30 minutes. They will get a snack or meal.~        -  They will be told how to take care of the tongue for the rest of the day.~      Participants will be called a week later to see how the~   "
15337|NCT03366155|"~     Background:~      Many people with colorectal cancer get liver metastases. Standard treatment for this is a~     combination of chemotherapy drugs. Directing the chemotherapy to the liver may be effective.~     A device that does this a pump that delivers drugs over 2 weeks at constant rate into the~     hepatic artery. The person s body temperature causes the drug to flow from the pump.~     Researchers want to see if this helps people with colorectal metastases to the liver.~      Objective:~      To study the effectiveness of a hepatic artery infusion pump at treating colorectal~     metastases to the liver.~      Eligibility:~      Adults at least 18 years old with colorectal metastases to the liver~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Heart, blood, and urine tests~      Scans~      Participants will stay in the hospital a few days. A small plastic tube (catheter) will be~     inserted in an artery into the liver. The catheter will be attached to the pump. That will~     lie under the skin on the abdomen. It will be small and participants will be able to feel it.~      Participants will get treatment in 28-day cycles.~      Every Day 1, they will have physical exam, symptom review, and blood tests.~      Every 2 weeks, they will come to the clinic to get chemotherapy by a catheter or port.~      Every 12 weeks, they will have a scan.~      Tissue samples may be taken during the study.~      When they finish the drug, participants may have the pump removed. They will repeat the Day 1~     tests. They will be called every 6 months to see how they are doing.~      Sponsoring Institute: National Cancer Institute~   "
15338|NCT03366142|"~     Background:~      The disease leukocyte adhesion deficiency type 1 (LAD1) affects white blood cells. Those are~     immune system cells. In people with LAD1, white blood cells do not properly communicate with~     the rest of the body. This causes uncontrolled inflammation, particularly in the gums. People~     with LAD1 can get frequent infections and tend to lose their teeth before adulthood.~     Researchers want to see if a drug called ustekinumab helps people with LAD1.~      Objective:~      To study the safety and tolerability of ustekinumab in treating gum inflammation in people~     with LAD1.~      Eligibility:~      People ages 12 65 with LAD1~      Design:~      Participants will be screened with:~        -  Medical history~        -  Physical exam~        -  Oral exam~        -  A scan of the chest, abdomen, and pelvis for possible infection~        -  Blood and urine tests~      The baseline visit will take 2 days. Participants will:~        -  Repeat most screening tests~        -  Have a skin exam~        -  Have small pieces of their gums removed (biopsy)~        -  Have mouth fluids collected~        -  Get the study drug injected under the skin of the abdomen, thigh, or elsewhere on the~          body. They will be watched for at least 2 hours.~      Participants will be instructed on tracking how they are feeling and any side effects.~      Participants will have 4 more visits over 40 weeks. They will get the study drug and repeat~     the baseline tests.~      Participants may have up to 5 more tissue biopsies.~      Participants will be called between visits to discuss how they are feeling and side effects.~      Participants will have a final visit 52 weeks after the baseline. They will repeat most of~     the baseline tests.~      Participants will answer questions about their oral ulcers.~   "
15339|NCT03366129|"~     Background:~      A stroke occurs when not enough blood reaches the brain. Sometimes stroke causes changes in~     certain brain matter. This is called white matter hyperintensity (WMH) and can lead to mental~     decline. But not all WMH is caused by stroke. Not all people with WMH experience mental~     decline. Researchers want to learn more about WMH. They want to see if it is related to~     disruptions in the blood-brain barrier.~      Objective:~      To better understand the how blood-brain barrier disruption is related to white matter~     hyperintensities.~      Eligibility:~      Adults at least 18 years old who have been admitted to a study site with stroke-like symptoms~      Design:~      Participants will be screened with an MRI scan and cognitive tests.~      Participants will have 11 visits over 6 years. Each visit will be 3 4 hours.~      At each visit, participants will:~      Update their medical history~      Have a thin plastic tube (catheter) inserted into an arm vein by needle~      Have an MRI. The scanner is a metal cylinder in a strong magnetic field. Participants will~     lie on a table that slides in and out of the cylinder. Participants will be in the scanner~     about 60 minutes, lying still for up to 20 minutes at a time. They will get earmuffs for loud~     sounds.~      Have a dye injected through the catheter during the MRI~      Have tests of movement, language, and cognition~      Some participants will have an extra visit for an MRI in a stronger scanner (7T MRI).~      Participation for some participants will be authorized by their legal representative.~   "
18074|NCT03330366|"~     The researchers investigated the anti-diabetic effects of Allium hookeri root extract for~     Korean prediabetic participants.~   "
15340|NCT03366116|"~     Background:~      Blood, tissue, and tumor cells contain genes. Genes are made up of DNA. DNA is the~     instruction book for each cell. In some people with cancer, the genes that might have slowed~     the growth of their tumor were turned off. Researchers want to see if a new drug can turn the~     genes back on and slow the tumor growth. The drug is called Aza-TdC.~      Objective:~      To test the safety of Aza-TdC, and to find out the dose of this drug that can be safely given~     to humans.~      Eligibility:~      People ages 18 and older who have advanced cancer that has gotten worse after standard~     treatment, or for which no effective therapy exists~      Design:~      Participants will be screened with:~      Medical history~      Blood and urine tests~      Scans to measure their tumors~      Test to measure the electrical activity of the heart~      Participants will take the study drug by mouth. The drug is given in cycles. Each cycle is 21~     days (3 weeks) long.~      Week 1 and week 2: participants will take the study drug once a day for 5 days. Then they~     will have 2 days without the drug. Week 3: no study drug is taken. This completes one cycle~     of treatment.~      For cycle 1, participants will repeat the screening tests several times. For all other~     cycles, participants will have blood tests and pregnancy tests. They will have scans of their~     tumor every 6 weeks.~      The cycle will be repeated as long as the participant tolerates the drug and the cancer is~     either stable or gets better.~      Sponsoring Institute: National Cancer Institute~   "
15341|NCT03366103|"~     This phase I/II trial studies the best dose and side effects of navitoclax and how well it~     works when given together with vistusertib in treating patients with small cell lung cancer~     and solid tumors that have come back. Drugs used in chemotherapy, such as navitoclax, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Vistusertib may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. Giving navitoclax and~     vistusertib may work better in treating patients with small cell lung cancer and solid~     tumors.~   "
15342|NCT03366090|"~     Inflammatory Bowel Diseases (IBD) is a heterogeneous group of diseases regarding clinical~     presentation, disease course and treatment response. Pathogenesis is complex and~     multifactorial, based on interactions between genetic and environmental factors, gut~     microbiota and the immune system, leading to intestinal inflammation. As the immune reaction~     itself causes the intestinal damage, differences in components of this immune mediated~     inflammatory reaction between IBD patients might explain the heterogeneity in response to~     different therapy strategies. Identifying immune components that are associated to disease~     activity and prognosis would enable a more personalized treatment.~   "
15343|NCT03366077|"~     Urinary tract infections (UTIs) are the most common bacterial infections in women, with about~     50% of women experiencing at least one UTI in their lifetime.~      The main pharmacological treatments of cystitis usually involve the use of antibiotics, in~     particular quinolones (such as ciprofloxacin and levofloxacin), fosfomycin, second-generation~     and third-generation cephalosporins, and b-lactam antibiotics associated with b-lactamase~     inhibitors.~   "
15344|NCT03366064|"~     This phase 1 trial investigate safety and maximum tolerated dose of natural killer (NK) cells~     derived from haploidentical family donors in patients with non-small cell lung cancer~   "
15345|NCT03366051|"~     This study will evaluate the role of systematic lymphadenectomy after sentinel node (SLN)~     mapping in high risk endometrial cancer (high grade histologies or deep myometrial invasion).~     The participants will be randomized in a non-inferiority controlled trial in 2 groups: SLN~     mapping or SLN mapping followed by systematic lymphadenectomy.~   "
15346|NCT03366038|"~     Pancreaticoduodenectomy (PD) is one of the most complicated surgical procedure and one of the~     standard treatments for benign and malignant disease of pancreatic head and periampullary~     region. Improvements in surgical techniques and the perioperative management of patients~     undergoing PD have reduced the surgical mortality rates to less than 3% in high-volume~     medical centers. However, the incidence of postoperative complication remains high, which~     ranges from 30% to 50% and the pancreatic fistula rate ranges from 5% to 40%. The key point~     of PD is still the enteric reconstruction of pancreatic stump. There were different~     techniques of enteric reconstruction, including: invagination pancreaticojejunostomy, binding~     pancreaticojejunostomy, duct-to-mucosa pancreaticojejunostomy, Roux-en-Y~     pancreaticojejunostomy, and pancreaticogastrostomy and each technique had its advantages and~     disadvantages. We established a new digestive reconstruction technique named shark mouth~     modified pancreaticojejunostomy, which had theoretical advantages including easier performed;~     lower tension and less complication. The shark mouth modified pancreaticojejunostomy is an~     end-to-end pancreaticojejunostomy procedure which is between invagination~     pancreaticojejunostomy and binding pancreaticojejunostomy.The remnant of jejunum is shaped as~     shark mouth and then sutured with the pancreas remnant. After the surgery, the patients will~     be well followed up. The pancreaticojejunostomy time, post-operation complication, mortality~     and hospital stay will be documented to study the safety, efficiency and advantage of this~     new procedure.~   "
15347|NCT03366025|"~     The current study, aims through a robust design to provide a simple answer on whether~     progesterone levels of the same individual may significantly vary depending on the time of~     blood retrieval before the ovulation triggering, by evaluating the daily variability of serum~     progesterone on the day of triggering in healthy women who perform a COS for oocyte donation,~     through multiple blood samplings.~   "
15348|NCT03366012|"~     This study aims to evaluate the acceptability of a new non-invasive screening device to test~     for Barrett's esophagus. The investigators will prospectively enroll 100 patients to undergo~     Cytosponge testing. The time of involvement for an individual will range from 2 weeks to 2~     months, depending on the results of the Cytosponge test and time to follow up endoscopy, if~     indicated.~   "
15349|NCT03365999|"~     This study compares two oral medications (tranexamic acid and aminocaproic acid) as~     hemostatic agent administered in patients undergoing total knee replacement.~   "
15350|NCT03365986|"~     The purpose of the this study is to determine the prevalence of germline cancer~     susceptibility gene mutation among Chinese population, and to find best ways to screen~     patients with colorectal cancer in China. To accomplish this objective, the investigators~     will establish a large sample database of hereditary colorectal cancer related information~     using multigene panel testing based on Next-Generation Sequencing.~   "
15351|NCT03365973|"~     The purpose of this study is to identify potential risk factors for and determine the rate of~     pathological fracture for patients which having spine metastases from breast cancer and be~     defined as potentially unstable (SINS 7-12) according to the Spinal Instability Neoplastic~     Score (SINS). The investigators' analysis will provide robust data about the development of~     spinal instability and help identify the optimal timing of local surgery treatment.~   "
15352|NCT03365960|"~     The primary objectives of the study are outlined below:~        1. To investigate the relative bioavailability and absorption/kinetic profile of~          polyphenols after consumption of watermelon rind, flesh and seeds, respectively in an~          acute pilot study.~        2. To study the effects of watermelon intake on endothelial function using the FMD~          technique and to understand the relationship between plasma metabolites, including~          L-citrulline and arginine, and FMD responses.~   "
15353|NCT03365947|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and~     pharmacodynamics of single- and multiple-ascending doses of ARO-HBV in healthy adult~     volunteers and participants with hepatitis B virus (HBV).~   "
15354|NCT03365934|"~     This single center, randomized, 15-day clinical trial is being conducted to assess the~     changes to the skin microbiome of induced wounds on the back in approximately 35 healthy~     adult subjects aged 18-55 years, with Fitzpatrick Skin Types I - III. Microbiome and skin~     physiology assessments will be completed.~   "
15355|NCT03365921|"~     This study is to evaluate lot-lot consistency of Recombinant Hepatitis E Vaccine (Escherichia~     Coli) Hecolin®.~   "
15356|NCT03365908|"~     This study will compare the outcome of pain interventions that are considered standard of~     care during the surgical treatment of ACL injuries. The comparison will be looking at pain~     control during and after ACL surgery as well as functional outcomes in patients that had a~     nerve block versus those who did not. The investigators hypothesize that pain control will be~     equal between both groups.~   "
15357|NCT03365895|"~     This pilot early phase I trial studies how well diffusion tensor imaging works in predicting~     development of chemotherapy induced peripheral neuropathy in patients with breast cancer.~     Diffusion tensor imaging may help to get better pictures of the nerves of feet and lower legs~     before and after chemotherapy treatment and may help to predict the risk of developing~     peripheral neuropathy.~   "
15358|NCT03365882|"~     This randomized phase II trial studies how well trastuzumab and pertuzumab work compared to~     cetuximab and irinotecan hydrochloride in treating patients with HER2/neu amplified~     colorectal cancer that has spread from where it started to other places in the body and~     cannot be removed by surgery. Monoclonal antibodies, such as trastuzumab and pertuzumab, may~     interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy,~     such as cetuximab and irinotecan hydrochloride, work in different ways to stop the growth of~     tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them~     from spreading. Giving trastuzumab and pertuzumab may work better compared to cetuximab and~     irinotecan hydrochloride in treating patients with colorectal cancer.~   "
15359|NCT03365869|"~     The purpose of the study is to examine the safety and effectiveness of sirolimus treatment~     for people with systemic sclerosis.~      The investigators perform a multi-centre, double-blind pilot trial with sirolimus in SSc.The~     investigators evaluate the effectiveness and safeness of sirolimus for Systemic Sclerosis by~     randomized controlled study (sirolimus 2mg/d (N = 36) versus placebo group (N = 36)).~   "
15360|NCT03365856|"~     This study is the multi-center, open and cross-sectional study of RA remission in Asia~     Pacific region. The objectives is to explore remission rate of RA patients in different~     countries in the Asian-Pacific area using different criteria of remission (DAS28, CDAI, SDAI,~     ACR/EULA remission criteria, RAPID3 and Clin28) and investigate the associated factors of~     remission in RA patients.~   "
15361|NCT03365843|"~     Post-operative recovery after cardiac surgery is influenced by early sternal bone stability.~     Traditional sternal closure of median sternotomy usually entails the use of 6-10 stainless~     steel wires. Augmenting sternal closure with techniques to enhance early bone stability~     should accelerate functional recovery from cardiac surgery thereby reducing post-operative~     pain, decreasing the need for narcotics, improving breathing and chest wall mechanics,~     stimulating early mobility and expediting hospital discharge.~      This study is a randomized, single-centre, double-blind clinical study comparing the effects~     of Montage bone putty plus conventional wire closure vs conventional wire closure only on the~     post-operative recovery of cardiac surgery patients with full medial sternotomy.~   "
15362|NCT03365830|"~     Reproduction is in fact the most basic instinct of all living things. The fertility of a~     woman is both a biological fact and a determinant of gender role in society. Motherhood is~     still seen as the primary role for women in society. Infertility, which manifests itself as a~     sudden and unexpected life crisis, is an unexpected, perhaps unexplained, condition that~     spreads over a long period of time, creates extreme stress and forces adjustment mechanisms.~     Infertility can affect the quality of life by adversely affecting the physical, emotional,~     social and relational living spaces of people.~      The present study examines the effects of reproductive problems on the quality of life in~     women who receive infertility treatment, and in the direction of the results obtained, the~     treatment recipients of the health workers are planned to help develop a holistic perspective~     that takes into account not only reproductive problems but also other affected living areas.~   "
15363|NCT03365817|"~     This study evaluates the effects of opioid dose reduction in the treatment of chronic pain in~     adults. Participants were divided in two groups: 1) patients that reduced opioid dose and 2)~     patients that kept the same opioid dose for six months.~   "
15377|NCT03365635|"~     This is a study to define strategies for Nephrologists to directly supervise and apply direct~     acting antivirals to cure hepatitis C in hemodialysis patients. Strategies will include~     identification of candidate patients, application for insurance approval, specifics of direct~     acting antiviral therapy (Zepatier with or without ribavirin) and laboratory monitoring~     during and after therapy.~   "
15378|NCT03365622|"~     The aim of this study is to determine whether intravenous acetaminophen compared to enteric~     acetaminophen offers increased efficacy in patients who are scheduled for laparoscopic donor~     nephrectomy and for patients scheduled for robot-assisted, laparoscopic nephrectomy for renal~     cancer at the University of Rochester Medical Center. The standard surgical and~     post-operative care, including post-operative pain management will not be altered.~   "
15364|NCT03365804|"~     Adolescent Idiopathic Scoliosis (AIS) is a three-dimensional deformity of the spine due to an~     unknown cause. Bracing is a proven non-surgical treatment for scoliosis. Our group developed~     an ultrasound assisted method which can improve brace design. However, it is still quite time~     consuming to construct a brace. Although 3D printing technology has been proposed to~     construct a scoliosis brace, its effectiveness has not been validated. The goals of this~     study was to investigate if an effective and comfortable brace can be designed and fabricated~     by using ultrasound and computer-aided design and computer-aided manufacturing (CAD/CAM)~     technology, and be printed directly from a 3D printer with faster production, lower cost, and~     improved comfort to patients. Also, to investigate the effectiveness of new designed brace.~     The final outcomes may reduce the total number of spinal surgeries for scoliosis. The~     benefits not only reduce the health care cost, but also increase the quality of life of these~     adolescent patients.~   "
15365|NCT03365791|"~     The purpose of this signal seeking study is to determine whether treatment with PDR001 and~     LAG525 demonstrates sufficient efficacy in advanced malignancies to warrant further study.~   "
15366|NCT03365778|"~     The purpose of this study is to develop an educational program that will help improve the~     patients' understanding of what laser treatment is, how it might be beneficial to them, and~     why it should be the first glaucoma treatment to consider before the use of glaucoma eye~     drops.~   "
15367|NCT03365765|"~     This study will focus on postoperative patients of stage IIIB or stage IIIC colorectal~     cancer. These patients will start to accept chemotherapy in 3-4 weeks after operation, these~     patients were randomly divided into two groups, one group will accept adjuvant chemotherapy~     of mFOLFOX6; another group will use mFOLFOX6 combined with apatinib. The efficacy and safety~     of adjuvant chemotherapy will be compared between the two groups. Disease-free survival,~     overall survival, incidence of adverse reaction of chemotherapy and postoperative quality of~     life will be recorded.~   "
15368|NCT03365752|"~     Outpatient knee surgeries with duration of less than one hour pose a challenge to the use of~     spinal anesthesia given that traditional agents remain in effect for 2-3 hours, thus creating~     a mismatch between length of surgery and anesthetic resolution. The investigators hypothesize~     that the use of chloroprocaine can combine the benefits of a short spinal anesthetic while~     avoiding the side effects of a general anesthetic, thus promoting earlier discharge.~   "
15369|NCT03365739|"~     The primary objectives of the study are:~        1. To investigate the relative bioavailability and absorption/kinetic profile of~          phytochemicals after acute consumption of mango pulp.~        2. To study the systemic accumulation or generation of new mango pulp phytochemicals /their~          metabolites in blood after regular mango intake for an extended time frame.~        3. To enhance the bioavailability of polyphenols in mango pulp by addition of Vitamin C to~          the mango pulp.~   "
15370|NCT03365726|"~     Perioperative adverse cardiovascular events are the leading cause of morbidity and mortality~     after noncardiac surgery. The implications of perioperative cardiac complications on~     morbidity and mortality, in-hospital and long-term care, and resource utilization are~     enormous. The continuously increasing proportion of elderly patients presenting for~     noncardiac surgery raises serious concerns regarding adverse cardiac events in the~     perioperative period. The responsibility for early diagnosis and prompt treatment of cardiac~     complications during surgery rests squarely with the anesthesiologist. Reliable~     intraoperative identification of patients at high risk for postoperative AMI and/or death is~     currently inadequate, but may confer substantial benefits to patients as preventive measures~     could be instituted. A reliable and reproducible quantitative measure of regional and global~     myocardial function could improve preoperative risk stratification and guide anesthetic~     management when acute changes in myocardial function occur.~      In the present study is hypothesized that intraoperative dobutamine stress echocardiography~     by 2-dimensional speckle tracking echocardiography can identify patients at higher risk of~     perioperative adverse cardiac events.~   "
15371|NCT03365713|"~     This study will test how well short questionnaires, with and without a simple breathing test~     called 'peak flow', can identify people with COPD compared to the gold-standard diagnostic~     test called spirometry. We will test this in 10,500 people from three low- and middle-income~     countries, namely Nepal, Peru and Uganda. We will also examine the feasibility of~     implementing our case-finding intervention at scale.~   "
15372|NCT03365700|"~     A randomized trial has recently demonstrated non-inferiority of cryoballoon vs.~     radiofrequency (RF) catheter ablation in patients with drug-refractory paroxysmal atrial~     fibrillation (AF). There is a growing amount of evidence suggesting that Cryoballoon ablation~     is highly effective also in non-paroxysmal atrial fibrillation.~      The IRON-ICE trial will evaluate the effect of Cryoballoon AF ablation in patients with~     short-term persistent AF.~   "
15373|NCT03365687|"~     In this 7-month randomized controlled trial, children aged 1 to less than 6 years, with~     recurrent asthma attacks triggered mostly by colds, will receive a high dose of vitamin D or~     a placebo every 3.5 months during their usual clinic visit, and a daily supplement of vitamin~     D or a placebo. This study will test whether children in vitamin D group have less frequent~     and less severe asthma exacerbations compared with those receiving placebo.The study will~     also document the safety profile of this strategy.~   "
15374|NCT03365674|"~     The aim of this study is to evaluate the effects of vibration anesthesia for reducing pain~     induced by trigger point injection of gastrocnemius.~      Sixty patients were randomized into the vibration or placebo group. In vibration groups,~     vibrator head was applied (100Hz) on the popliteal fossa, during the trigger point injection.~     In placebo group, same vibrator head was applied with switch-off sate. Then, a visual analog~     scale to evaluate the pain of trigger point injection and a five-point Likert scale for~     patients satisfaction were compared between the two groups.~   "
15375|NCT03365661|"~     This is a phase II multi-institutional therapeutic study of a non-myeloablative T cell~     receptor (TCR) alpha/beta depleted haploidentical transplantation with post-transplant immune~     reconstitution using ALT-803 for the treatment of high-risk myeloid leukemia (AML),~     treatment-related/secondary AML, and myelodysplastic syndrome (MDS).~   "
15376|NCT03365648|"~     The purpose of this study is to evaluate the efficacy and safety of Lertal® as an add-on~     treatment for children affected by allergic rhinoconjunctivitis.~   "
23484|NCT03259581|"~     The aim of this study is to evaluate the safety of selective transarterial chemoembolization~     (TACE) of hepatocellular carcinoma (HCC) in the setting of an elevated total bilirubin, but~     relatively normal direct bilirubin.~   "
15379|NCT03365609|"~     With the resistance of Helicobacter pylori increasing, low and unsatisfactory eradication~     rate (64%) have been observed with standard triple therapy in European children. Which~     regimen is appropriate for Chinese children? There is no large scale, multi center studies in~     China about treatment, CYP2C19 gene polymorphism, resistance rate and resistance genotype.~     Investigators want to perform a research to compare four different treatment regimens（triple~     therapy, sequential therapy, bismuth quadruple therapy and concomitant therapy）as the~     first-line treatment of Helicobacter pylori in Chinese children and investigation of~     resistance, impact factors and changes of microbiota after the therapy. The results of the~     study will provide theoretical basis to make the new guideline of diagnosis and therapy of~     Helicobacter pylori in Chinese children. It advance instruct and norm the clinical practice~     for Chinese pediatrician to increase the cure rate of Helicobacter pylori and decrease the~     resistance.~   "
15380|NCT03365596|"~     Prediction of recovery from stroke can assist in the planning of impairment-focused~     rehabilitation. To achieve better prediction for clinical purposes, this study investigated a~     new prediction model with low inter-individual variability and high accuracy using~     neuroimaging techniques.~   "
15381|NCT03365583|"~     Vitamin B12 plays important roles in DNA synthesis and neurological functions. Vitamin B12~     deficiency is one of the most common micronutrient deficiencies and it has become~     increasingly more frequent in infants. The deficiency develops more often between 4 to 12~     months of age, coinciding with the decreased fetal storage. The highest rates of vitamin B12~     deficiency were observed among infants who are breastfed by mothers receiving a diet low in~     vitamin B12.~      The main objective of this study is to compare the gut microbial composition of healthy term~     exclusively breastfed infants with or without vitamin B12 deficiency. We hypothesized that~     gut microbiome differs between vitamin B12 deficient and control infants; pathogenic bacteria~     are hypothesized to be higher, and beneficial bacteria to be lower in vitamin B12 deficient~     infants as compared to control.~      An observational study in the Marmara University Pendik Research and Training Hospital well~     child outpatient clinic is conducted in 90 infants. Participants aged between 4 to 6 months~     who fulfill the inclusion criteria are enrolled.~      Inclusion criteria are term birth (>37 gestational weeks), birth weight >2500 gr, absence of~     congenital anomalies, hemoglobin ≥10 g/dL, and exclusive breastfeeding.~      Exclusion criteria include prematurity, low birth weight, intrapartum antibiotic use, current~     or previous use of infant formula, malnutrition, use of iron supplements, infant use of~     antibiotics, use of probiotics within the last 8 weeks before study entry, and introduction~     to solid foods.~      Primary outcome measures:Microbial counts, and a comparison of type and abundance of species~     (predominant, pathogenic, and opportunistic bacteria, yeast, and parasites) between vitamin~     B12 deficient and sufficient subjects will be assessed.~      Secondary outcome measures: Fecal bacterial communities will be assessed before and after~     treatment in a subgroup of infants.~      Each stool sample is collected from cloth diapers, and placed in sterile collection tubes.~     Samples are kept at 4 C and in less than 5 hours, they are frozen at -80 C until further~     analysis. Specimens are transported on dry ice to the Diagen Inc for DNA extraction.~      For the extraction protocol, QuickGene (Kurabo, North America) extraction device will be~     used.~      The extracted DNA samples will be sent to Diversigen Inc (Houston, USA) for analysis. Fecal~     microbiota composition will be analyzed with 16S ribosomal ribonucleic acid (rRNA)~     sequencing.~   "
15382|NCT03365570|"~     According to WHO Report (2002), iron deficiency anemia was considered to be the most~     important contributing factor to the global burden of anemia. Children and women in~     reproductive ages are more at risk factor for developing iron deficiency anemia (Suneeta,~     2007).No previous study has been held to assess prevalence of oral manifestations of iron~     deficiency anemia as a hospital-based cross-sectional study on a sample of Egyptian patients~     in hematology department (no previous data recorded).~   "
15383|NCT03365557|"~     The investigators aimed to explore the effects of airway peak pressure (Ppeak) guidance on~     the least laryngeal mask airway (LMA) intracuff pressure setting during general anesthesia~     and the effects on postoperative complications in the throat. Sixty patients (American~     Society of Anesthesiologists grades I or II) scheduled for elective gynecological~     laparoscopic operation under general anesthesia were enrolled in our study. The patients were~     divided into pressure-regulated group (group P) and control group (group C) randomly. Size 4~     Supreme LMA was inserted in after general anesthesia induction. Air was injected into the~     cuff to make the intracuff pressure (ICP) achieve 60 cmH2O. Volume-controlled ventilation was~     selected and Ppeak was recorded. In group P, all the gas in the LMA cuff was sucked out, and~     then air was injected in during expiration phase to make ICP achieve the level of Ppeak. If~     there's any leakage, increase 5 cmH2O every time till there's no air leakage from the mouth.~     After pneumoperitoneum, the cuff was inflated to make ICP achieve 60 cmH2O and Ppeak was~     recorded once more. Then all the gas in the LMA cuff was sucked out, and air was injected~     into the cuff during expiration phase to make ICP achieve the level of Ppeak as the above~     method till the end of operation. During pneumoperitoneum, the pressure of CO2 was set at 10~     cmH2O. In group C, ICP was maintained at 60 cmH2O. Ppeak, ICP and the intracuff gas volume~     were recorded before and after pneumoperitoneum. ICP during inspiratory phase in the two~     groups was measured. Tidal volume during inspiration (VTI) and expiration (VTE) in the two~     groups were recorded, and the leakage rate was calculated as [(VTI－VTE)/ VTI×100%]. Throat~     complications of all the patients in 24 hours after surgeries were also recorded.~   "
15384|NCT03365544|"~     This study will examine the effect of eating timing on body composition. Previous studies~     have shown that restricting food intake to 8 hours a day can result in losses in body fat and~     an up-regulation of fat use. The purpose of this study is to assess changes in body~     composition when the eating window time is from 6am-2pm vs 2pm-10pm.~      Hypothesis: The 2-10pm eating window will result in significantly greater changes in body~     composition (i.e. decreased fat mass) and the 2pm-10pm window will result in better~     adherence.~      Methods: Body composition (fat and lean mass) will be assessed by air displacement~     densitometry (Bod Pod). Measures will be made over 4 weeks (pre-) and (post) dietary~     treatment. Adherence will also be assessed by a questionnaire to determine the~     ease/difficulty of the treatment.~   "
15409|NCT03365219|"~     Post cesarean section surgical site infection (SSI) is a common complication that can affect~     patient recovery and overall outcome. Several approaches have been studied to improve SSI~     rates such as timing of antibiotic administration and skin preparation. Alexis retractors~     have been suggested as a reasonable option to decrease SSI. However, to date there is only~     one randomized controlled study assessing its efficacy. The aim of this study is to whether~     Alexis wound retractors are beneficial in preventing cesarean section SSI.~   "
15410|NCT03365206|"~     The aim of this study is to identify the knowledge and behavior on dental health and hygiene~     among adolescents. In most cases, the investigators know tooth decay can be prevented and~     reversed at an early stage by observing good oral hygiene. Few studies have been done among~     adolescents.~      This study could justify the implementation of public health actions in terms of prevention.~   "
23499|NCT03259386|"~     The purpose of this study is to learn more information about nerves. This study is also~     designed to learn how the information in nerves could be used to develop new prosthetic~     devices.~   "
15385|NCT03365531|"~     Non-alcoholic fatty liver disease (NAFLD) in patients with diabetes (T2DM) is increasing in~     prevalence and can lead to cirrhosis. Lifestyle intervention with caloric restriction (CR) is~     the cornerstone of treatment but remission is variable. Alternatively, the PI has shown~     alternate day fasting (ADF) is safe and well tolerated in obese patients and there might be~     additional beneficial effects. The objective is to combine the expertise of the PI with this~     novel intervention and the expertise of Dr. Cusi in NAFLD to explore the effects of ADF vs CR~     in patients with NAFLD and T2DM to test the following hypotheses:~      H1: In patients with NAFLD and T2DM, the ADF intervention will result in more favorable~     metabolic changes than CR:~      H1a: Hepatic triglyceride by MRS will decrease more with ADF than CR (Primary Outcome) and~     remain lower following a period of free living H1b: There will be greater improvements in~     glucose homeostasis following ADF vs CR H1c: There will be greater improvement in lipid~     metabolism following ADF vs CR and changes in ketone metabolism will predict changes in~     hepatic triglyceride content H2: ADF will have similar safety and tolerability and result in~     a similar degree of weight loss in participants with NAFLD and DM compared to CR~   "
15386|NCT03365518|"~     Up to 90% of men experience sexual difficulties after receiving treatment for prostate cancer~     (PC), which can negatively affect their intimate relationships and overall quality of life.~     In this randomized clinical trial, the investigators will assess and compare two~     evidence-based treatments, mindfulness-based therapy and cognitive behavioral therapy (CBT),~     for couples with sexual complaints following PC treatment to controls who will receive no~     intervention.~   "
15387|NCT03365505|"~     Frailty is known as an independent risk factor for morbidity and mortality in older cardiac~     patients . It is an important factor on the cardiologist decision between conservative and~     invasive treatment in older patient with acute coronary syndrome, and is usually made~     subjectively by the cardiologist known in the literature as eyeball testing.~      in this study the investigators will compare the cardiologists eye ball testing to objective~     frailty assessment based on Fried score and Edmonton frailty scale.~   "
15388|NCT03365492|"~     The purpose of this pharmacokinetic (PK) study is to characterize the maximum concentration~     (Cmax) and time-to-maximum concentration (Tmax) of Biolimus A9TM and its active metabolites~     sirolimus and everolimus in a cohort of coronary artery disease (CAD) patients following~     implantation of BioFreedomTM SS stent.~   "
15389|NCT03365479|"~     Primary objective~      • To evaluate the effect of rapid inhalation of 2.5μgiloprost using the Breelib nebulizer on~     pulmonary vascular resistance (PVR) in patients with pulmonary arterial hypertension~      Secondary objectives~        -  To evaluate the effect of rapid iloprost inhalation using the Breelib nebulizer on mean~          pulmonary arterial pressure (mPAP), cardiac output (CO), cardiac index (CI), systemic~          blood pressure, arterial oxygen saturation, heart rate, and pulmonary arterial wedge~          pressure (PAWP).~        -  To evaluate the safety and tolerability of the rapid iloprost inhalation using the~          Breelib nebulizer.~   "
15390|NCT03365466|"~     The aim of the study is to investigate whether Low Dose Aspirin and Low Molecular Weight~     Heparin could increase the uterine perfusion, and finally improve the implantation and~     pregnancy rates in patients with unexplained recurrent implantation failure.~   "
15391|NCT03365453|"~     In Italy, life expectancy at birth has reached 80 years in men and 85 in women; in about 50~     years, life expectancy at the age of 80 has increased by an extraordinary 61% and 55%,~     respectively, due to more effective therapies and lower mortality of many diseases. Yet,~     chronic diseases are nowadays more important, and often coexist as comorbidity or~     multimorbidity, depending on whether an index condition has been considered. These conditions~     increase the risk of death and reduce functional autonomy in the elderly and, therefore,~     should be carefully considered within comprehensive geriatric assessment. The epidemiology of~     valvular disease shows a clear trend in age-dependent, as the number of events and their~     incidence increases with age, and about half are concentrates over 75 years.~      In addition, some observational studies in elderly patients have suggested an association~     between frailty and cardiovascular disease: fragility and cardiovascular disease share a~     common biological pathway, and cardiovascular diseases may accelerate the onset of frailty.~     The frailty syndrome was identified in 25% to 50% of patients with cardiovascular disease,~     according to the rating scale used and the population studied. Frail patients with~     cardiovascular disease, in particular those undergoing invasive procedures or suffering from~     coronary artery disease and aortic valve disease, have a much higher adverse events and~     complications, suggesting the need for a more accurate functional stratification and a more~     careful evaluation of the risk/benefit ratio of some invasive procedures.~      Among the numerous tests proposed in the literature for the functional evaluation and~     objective measures of physical capability in elderly patient, the Short Physical Performance~     Battery (SPPB) and the evaluation of hand grip strength (grip strength) are those~     characterized by an improved prognostic ability and an easy administration.~      The present study is performed to assess if SPPB and handgrip are helpful to better stratify~     the prognosis (all-causes death and hospital admission for all causes) in elderly patients~     admitted to hospital for cardiac causes.~   "
15392|NCT03365440|"~     The aim of the study is to develop and validate a novel esophageal mapping system to improve~     the diagnostics of cardiac arrhythmias. Using a newly designed esophageal ECG catheter,~     esophageal ECGs (eECGs) will be recorded in 40 patients during an electrophysiological (EP)~     study and/or ablation procedure and in 12 healthy volunteers. In parallel acquired~     intracardiac electrograms will serve as reference for the developed mapping systems accuracy.~     Additionally, the esophageal mapping system will be compared to that of the standard 12-lead~     surface ECG in regard to its diagnostic performance.~   "
15393|NCT03365427|"~     This study is designed to estimate the effect of an application on rehabilitation for~     osteoarthritis patients after total knee arthroplasty.~   "
15411|NCT03365193|"~     Infective endocarditis is a potentially lethal disease that has undergone major changes over~     the last decades. The Duke Criteria are recommended for evaluation of probability of presence~     of infective endocarditis by current ESC guidelines. However, since the introduction of Duke~     criteria in 1994, characteristics of patients presenting with potential infective~     endocarditis have substantially changed, especially in tertiary care facilities, towards a~     high proportion of patients with immune deficiency (caused by illness or medically induced),~     critically ill patients, patients with prosthetic valves and patients with long-lasting~     intensive care treatment. Likewise, with the increasing interventional therapy of structural~     heart disease and device implantation in older and multi-morbid patient cohorts, the~     frequency of endocarditis on prosthetic material and devices increased over the last decades.~     While Duke criteria overall misclassify a substantial proportion of patients with~     endocarditis, Duke criteria are difficult to apply in these patients because of lower~     sensitivity. Therefore, several modifications of the Duke criteria have been proposed. In~     addition, the uncertainty regarding potential infective endocarditis of treating physicians~     due to clinical characteristics of their patients leads to an increase in requests for~     transthoracic and transesophageal echocardiography, overcoming echocardiography laboratories.~     In the present study the investigators aim to identify (I) the precision of the Duke score in~     predicting presence of infective endocarditis in patients examined at the echocardiography~     laboratory of the West German Heart Center (II) determine characteristics, not including~     echocardiography that are associated with increased risk of infective endocarditis,~     justifying transesophageal echocardiography examination and (III) establish scoring~     algorithms to help treating physicians to assess the risk of endocarditis in severely~     diseased patient cohorts prior to echocardiography examinations and to avoid unnecessary echo~     exams.~   "
15394|NCT03365414|"~     POTS is a relatively common condition that affects millions of patients around the globe. It~     has an estimated prevalence of 170/100,000 with approximately 80% of patients being women of~     childbearing age. POTS is characterized by an excessive heart rate increase on assuming an~     upright posture, either standing or even sitting and leading to disabling palpitations,~     light-headedness, and even in syncope in severe cases. More than 95% patients with POTS have~     pronounced cardiovascular deconditioning and show marked exercise intolerance. The severity~     of POTS is variable. In mild cases the affected patient may continue with routine activities~     with minimal limitations. Severe form of the disease precludes most normal life activities,~     such as sitting upright, walking or standing to perform even basic house chores. An estimated~     40% of patients with POTS have a resistant form of the condition that is nonresponsive or~     mildly responsive to all treatments resulting in continued functional limitations in the long~     term.~      Many of the currently available treatments in POTS are geared towards increasing blood~     pressure. These include compression stockings, increased daily fluid intake and increased~     salt ingestion. Saline infusions may be helpful in certain patients in the short term, though~     many do not respond. The effectiveness of medications varies greatly, with many patient~     failing to improve.~      A small series of clinical patients suffering from severe POTS have shown robust response to~     weekly albumin therapy, which supports the hypothesis that periodic albumin infusions will~     provide significant and sustained symptomatic relief to patients with severe POTS.~      This pilot study will explore the effectiveness of albumin infusions as a treatment for POTS.~     Eligible patients will receive weekly intravenous infusions of 5% Albumin or Saline in a~     double blinded fashion for 4 weeks and will crossover to the other infusion for 4 weeks after~     an intervening 4-week washout period. The participants will be required to maintain a daily~     diary of their symptoms during the screening, the study and washout periods. Any possible~     adverse effects as the result of infusions will be documented. Outcome measures will be~     quantified and validated at the end of each study period and the percentage reduction of~     tachycardia will be determined at the completion of each study arm.~   "
15395|NCT03365401|"~     Decompression surgery has proved to be effective for Lumbar Spinal Stenosis (LSS) with~     persistent pain. But the efficiency of the surgery for degenerated LSS remain uncertain and~     is the subject of this study. This is a multiple center open-label randomised trial. Patients~     were randomly allocated to surgical group or a nonoperative group. Because of the procedure ,~     neither patients nor investigators were blinded. The primary outcome is the change of symptom~     measure by the Oswestry disability index 6, 12, and 24 months after procedure.~   "
15396|NCT03365388|"~     Alge as a positive control drug, in patients with periarthritis of shoulder, in a~     double-blind, controlled manner to study the safety and treatment of Sodium Hyaluronate~   "
15397|NCT03365375|"~     This Emergency Department based study investigates the feasibility and effectiveness of a~     mindfulness based stress reduction (MBSR) training program referral for patients with chest~     pain at low risk for acute coronary syndrome but associated with anxiety. Outcomes assessed~     for eligible patients randomized to MBSR vs. usual care include mental health (longitudinal~     Generalized Anxiety Disorder - 7 (GAD-7) scores), quality of life (PROMIS Global Short Form),~     and ED resource utilization (return Emergency Department (ED) visits).~   "
15398|NCT03365362|"~     This 2 x 2 factorial, randomized, double-blind, placebo-controlled trial will test two~     interventions: directly observed medication therapy, and long-term therapy with varenicline~     among 450 smokers with opioid use disorder recruited from community-based, outpatient opioid~     treatment programs. The analytic strategy will evaluate the milestones in smoking~     cessation—achieving initial abstinence, preventing lapse and preventing relapse--necessary~     for long-term cessation, and evaluate theoretically-guided psychological and social factors~     and pharmacogenetic factors that influence these cessation processes.~   "
15399|NCT03365349|"~     a randomized prospective study aims at comparing the impact of a living theater session~     with a simple writing workshop  on emotional distress (Problem Areas in Diabetes~     Questionnaire PAID) and illness perception ( Illness Perception Questionnaire IPQR) during a~     5 day education course~   "
15400|NCT03365336|"~     The aim of this study is to determine the efficacy of Flu care polyherbal formulation in the~     management of acute uncomplicated case of Influenza within 48 hours of symptoms onset.~   "
15401|NCT03365323|"~     This retrospective study aims to improve the diagnosis of PJI as well as to identify~     microorganisms causing periprosthetic joint infection (PJI) and the drug-resistant spectrum~   "
15402|NCT03365310|"~     The aim of this study is to determine the efficacy of turmeric and tulsi polyherbal~     formulation in the management of frailty in the elderly population.~   "
15403|NCT03365297|"~     Testing if short-term use of apalutamide can reduce image defined tumour volumes in men with~     detectable lesion on multi-parametric Magnetic Resonance Imaging (mpMRI) and being managed by~     Active Surveillance. The trial will also evaluate the tolerability and side effect profile of~     men on AS using short term apalutamide and patient acceptability as a therapeutic strategy,~     as well as determining feasibility of a larger prospective randomised trial of apalutamide.~   "
15404|NCT03365284|"~     This study aims to investigate the effect of Smart Kneebrace use for osteoarthritis patients~     after total knee arhtroplasty (TKA) on post-operative performance.~   "
15405|NCT03365271|"~     This multicenter clinical trial aims to investigate the exact effect of drainage use for~     osteoarthritis patients in total knee arthroplasty (TKA) on post-operative performance.~   "
15406|NCT03365258|"~     Malnutrition is very common in critically ill patients. It is quite important to evaluate~     nutritional status precisely. Heyland et al firstly reported NUTRIC score including age,~     APACHE II score, SOFA score, number of commorbidities, days from hospital to ICU admission~     and IL-6. Because the IL-6 is not routinely checked at ICU. A modified NUTRIC score without~     IL-6 is more practical. Previous studies showed lower in-hospital mortality in higher~     nutritional risk patients with higher caloric intake compared with lower caloric intake.~     However, there is still controversial regarding the in-hospital mortality between full~     caloric feeding and permissive underfeeding in critically ill patients. Herein the~     investigators conduct a study to investigate what kinds of nutritional supplements will~     decrease in-hospital mortality in different nutritional risk patients.~   "
15407|NCT03365245|"~     A partial least squares regression model for visual field testing among glaucoma patients~     will be developed.~      In addition, microperimetry will be compared to conventional perimetry and reproducibility~     will be assessed.~   "
15408|NCT03365232|"~     compare the chair side time, clinical orthodontic attachment bond failure and accuracy of~     transfer between non custom attachment base and custom attachment base indirect techniques.~   "
15481|NCT03364283|"~     The main objectives of this study are comparison of the incidence of intraoperative air~     embolism and the extent of blood loss in patients undergoing posterior cranial fossa (PCF)~     and pineal region (PR) surgeries in sitting and horizontal position. Additionally, the~     overall treatment outcome, neurological functional outcome, degree of tumor removal, clinical~     course in the postoperative period, and the patient satisfaction will be compared between the~     groups.~   "
15412|NCT03365180|"~     The concept consists of an initial period (two weeks) of intensive data capture by use of~     continuous glucose monitoring (CGM) during basal insulin initiation, followed by a second~     period (variable duration) of basal insulin titration guided by self monitored blood glucose.~     Data captured during the first period are used as input to an algorithm that estimates the~     optimal daily dose for the individual patient. The estimated optimal daily dose is used to~     guide the titration of the basal insulin during the second period. The goal is to safely and~     successfully achieve blood glucose targets. The concept is based on the use of basal insulin~     degludec (Tresiba, Novo Nordisk A/S).~   "
15413|NCT03365167|"~     this study evaluate the effect of LANAP (Laser Assisted New Attachment Procedure) as an~     Adjunct Treatment in Management of Patients With Chronic Periodontitis and assay the effect~     of LANAP on periodontal indexes like BOP, CAL, probing depth~   "
15414|NCT03365154|"~     This trial is a First in Human early feasibility study of a novel atherectomy device to treat~     peripheral artery disease. The trial is a prospective, single arm design that will enroll 10~     patients at 1 - 2 sites. Patients will be followed at 30 days and 6 months to evaluate vessel~     patency following treatment. Safety will be assessed by monitoring adverse events throughout~     the study. Safety and Efficacy will be evaluated by comparing study results to established~     performance criteria,~   "
15415|NCT03365141|"~     A randomized split-body pilot study was planned to confirm efficacy of intralesiona~     triamcinolone injection in patients with vitiligo~   "
15416|NCT03365128|"~     This is a study to validate the efficacy of using a small portable oxygen source to mitigate~     altitude-induced hypoxia.~   "
15417|NCT03365115|"~     This study is planned to investigate the efficacy of combined infusion of intrathecal~     morphine and fentanyl in patients undergoing total knee arthroplasty.~   "
15418|NCT03365102|"~     As a first step toward investigating whether modulation of impulsivity and associated neural~     pathways may yield clinically meaningful changes in risk for adolescent suicidal behavior,~     the R21 is a proof-of concept study evaluating the potential for tDCS targeting brain regions~     associated with behavioral impulsivity (right inferior frontal gyrus [rIFG]) and cognitive~     impulsivity (left orbitofrontal cortex [lOFC]) to modulate these facets of impulsivity in a~     sample of adolescent suicide attempters. Participants will be randomly assigned to receive~     anodal tDCS over the rIFG, anodal tDCS over the lOFC, or a sham stimulation condition, in a~     three-group design. Task-based measures of behavioral and cognitive impulsivity will be~     administered before and after tDCS or sham stimulation. Additionally, EEG and ERP data will~     be collected during the impulsivity tasks, and resting-state EEG data will be collected pre-~     and post-tDCS administration to confirm engagement of the targeted brain regions and to~     delineating the neural pathways underlying the effects of tDCS on impulsivity.~   "
15419|NCT03365089|"~     Arteriovenous fistulas (AVFs) for hemodialysis often fail to become usable due to failure to~     mature (FTM). The most common cause is narrowing of the artery or vein (stenosis). Another~     potential cause is the presence of collateral or side branch veins that steal blood flow from~     the main fistula channel. Some believe that occluding these veins might help maturation of~     those failing AVFs. To evaluate if this actually works, patients with FTM will be randomly~     assigned to side branch vein ligation (or not), and rates of AVF maturation of the two groups~     will be compared.~   "
15420|NCT03365076|"~     Previous research into metabolic and hypoxic markers has found evidence of preclinical impact~     of exercise on prostate tumor blood flow and oxygenation in rodents . As radiotherapy is a~     frequently used and effective therapy for and that sufficient oxygenation is decisive to the~     effect of radiotherapy, an underlying hypothesis that aerobic exercise might improve~     treatment efficacy of radiotherapy in prostate cancer is put forward. This study has a~     potential challenging intervention, but a potential very high gain as it includes active~     patient participation to significantly improve outcome of radical radiotherapy.~   "
15421|NCT03365063|"~     Chronic kidney disease (CKD) and its end stage of kidney failure are major public health~     problems in Canada and worldwide. In the primary care setting, accurate prediction of the~     risk of kidney failure in patients with CKD can improve patient provider communication,~     assist in appropriate nephrology referral, improve dialysis treatment planning, and identify~     patients who are most likely to benefit from intervention. To aid in accurately predicting~     the risk of kidney failure requiring dialysis in patients with CKD, the primary investigator~     has developed and validated the kidney failure risk equation (KFRE), which is increasingly~     used in nephrology practices across Canada and the United States.~      In this current study, a cluster randomized controlled trial (RCT) will be done in~     collaboration with the Canadian Primary Care Sentinel Surveillance Network (CPCSSN). Primary~     care clinics that can integrate the KFRE into their electronic medical records will be~     randomized to receive the intervention (patients and providers receive individualized~     information explaining kidney failure risk, as well as risk-based criteria for referral,~     alongside usual care) versus usual care alone (no information on personalized risk and no~     risk-based referral). In both groups, the investigators will assess management of patients at~     high risk of kidney failure (patient), timing of referral for patients at high risk of kidney~     failure (health system), cost of CKD care (health system), CKD-specific health literacy~     (patient), trust in physician care (patient), and satisfaction with risk prediction tools~     (provider).~      The objective of this research study is to develop, implement, and evaluate tools to guide~     the care of patients with CKD in the community, including appropriate referral using a~     risk-based approach. Specifically, this study will address the question: Does providing~     patients (and their physicians) with information about their risk of kidney failure improve~     quality of care, health literacy, and trust in the care they are receiving?~   "
15422|NCT03365050|"~     This study is a data linkage project within which we aim to model the impact on the NHS AAA~     Screening programme of a targeted approach to screening by targeting men who smoke. This~     in-silico study will generate a hypothetical population based on primary care datasets with~     known outcomes from screening (we know which men have an aneurysm and who do not) to~     determine the feasibility and safety of this approach.~   "
15423|NCT03365037|"~     The aim of this study was to evaluate the efficacy and safety of electret static~     physiotherapy film developed by Beijing Youshilin science and Technology Development Co.,~     Ltd., to treat acute soft tissue injury by sticking to the affected area~   "
15424|NCT03365024|"~     Insomnia is a major problem among veteran populations. Insomnia impacts physical and mental~     health functioning and is associated with reduced quality of life. Cognitive Behavioral~     Therapy for Insomnia (CBT-I) is one of the most promising treatments for insomnia; however,~     access to CBT-I is severely limited by a lack of trained clinicians within the Veterans~     Health Administration (VHA). There is a critical need to offer innovative approaches to meet~     the demand and need for insomnia treatment. Leveraging technology to meet treatment demands~     is consistent with service delivery models based upon stepped care principles. This~     randomized controlled trial will determine whether a computerized, self-guided, web-based~     version of CBT-I is efficacious in reducing insomnia symptoms and improving functioning~     compared to a computerized program control.~   "
15425|NCT03365011|"~     Tinnitus is perception of sound without the presence of an external acoustic stimulus.~     Approximately 50 million Americans experience chronic tinnitus and of these, 10 million have~     bothersome tinnitus. The tinnitus research literature suggests that NMDA receptor antagonists~     may prove to be useful in reducing tinnitus. Nitrous oxide, a member of the NMDA receptor~     antagonist class, is a widely-used general anesthetic and sedative with a proven safety~     profile. The investigators hypothesized that the administration of nitrous oxide, an NMDA~     receptor antagonist, may be effective in treatment of tinnitus. The study design was a~     randomized placebo-controlled crossover trial.~   "
15426|NCT03364998|"~     The purpose of this study is to compare the pharmacokinetics of BAY94-9027 and Elocta after~     intravenous administration.~   "
15427|NCT03364985|"~     This is a dose block-randomized, double-blind, placebo- and active-controlled, single and~     multiple dosing, dose-escalation clinical phase 1 trial to investigate the safety,~     tolerability, pharmacokinetics and pharmacodynamics of DWP16001 after oral administration in~     healthy male volunteers.~   "
15428|NCT03364972|"~     This is a bilateral randomised controlled study to compare visual performance, refractive~     outcome, forward light scatter, patient satisfaction and objective measurement of glistenings~     following insertion of two monofocal, aspheric, hydrophobic acrylic intraocular lenses~     (IOLs). A new product is compared with an established one.~   "
15429|NCT03364959|"~     The main purpose of this open randomized, ex-vivo comparative study, is to assess and to~     compare the inhalable dose of inhaled corticosteroid collected through a nasal filter and a~     mouth filter located in a partitioned face mask and delivered to an infant with asthma via a~     Tipshaler® holding chamber~   "
15430|NCT03364946|"~     The study aims to describe the use of Nasal High Flow (NHF) in the intensive care units of~     participating centers in Iberoamerica. It will describe the indications for the use, the~     clinical outcome of patients , and the therapeutic failure of NHF therapy in patients staying~     in an intensive care unit in the participant centers in Iberoamerica.~   "
15431|NCT03364933|"~     This is a randomized control trial of PICU patients admitted for 7 days and expected to~     remain for at least another 3 days and who have a complex chronic condition. Patients will be~     randomized to usual care or usual care plus a primary intensivist and group of primary nurses~     (to facilitate passing of important patient information and informed, expedited~     decision-making). The primary research question is whether having a primary intensivist and~     nurses decreases PICU length of stay.~   "
15432|NCT03364920|"~     This is a retrospective study about serum Maresin-1 level in different severe acute~     pancreatitis patients. The investigators want to study the correlation between the level of~     serum Maresin-1 and the severity of SAP, of course the clinical outcomes. The investigators~     want to find some biomarkers and strategy target drugs of severe acute pancreatitis.~   "
15433|NCT03364907|"~     Currently, there is a lack of knowledge on the effect of additional flushing after HIPEC on~     tumour platinum exposure, systemic platinum exposure and platinum concentration in drain~     exudate and thereby personal exposure. Therefore the investigators want to perform a study to~     investigate the effect of flushing after HIPEC on tumour exposure, systemic exposure and on~     wound exudate concentration.~   "
15434|NCT03364894|"~     Background Our understanding of PD has stagnated, partly due to the limited patient diversity~     and brief followup captured in most study cohorts. Additionally, potentially valuable~     biomarkers derived from different types of measurements are rarely analyzed in an integrated~     fashion.~      Objective This study aims to create a longitudinal dataset of clinical, molecular, imaging,~     and continuous wearable sensor-based data from a representative Parkinson's disease (PD)~     cohort. Data will be made available to researchers worldwide to accelerate the discovery of~     novel etiological insights, development of new therapeutic approaches, and personalized~     disease management. For this purpose, an extensible norm for sharing research data will be~     developed, meeting the latest data privacy and security standards.~      Methods Supported by a multinational, public-private partnership, a prospective cohort study~     was designed to include 650 representative PD patients (disease duration <5 years).~     Comprehensive follow-up for at least 2 years includes: (1) annual assessment at the study~     center for acquisition of detailed clinimetric data, magnetic resonance imaging, and~     biospecimens (plasma, serum, cerebrospinal fluid (CSF), stool) and (2) collection of data~     from the home environment, using self-assessments and an advanced wrist-worn wearable device~     to continuously measure biological and environmental signals. Collection, storage, and~     sharing of these research data will be facilitated by a new method to protect privacy and~     enhance security using polymorphic encryption and pseudonymization (PEP), a methodology that~     combines advanced encryption with distributed pseudonymization and data access management.~      Conclusion This study is unique, as it includes a cohort of unbiased subjects with recently~     diagnosed PD, creating an unprecedented dataset that combines longitudinally collected~     clinical, molecular, imaging, and data from wearable sensors using state of the art~     technology. The single-center study design minimizes measurement variability. Finally, the~     innovative methodology for data privacy and protection might serve as a new international~     standard for sharing research data.~   "
15435|NCT03364881|"~     Right colon has complicated anatomy which is surrounded by important organs. The variations~     of vessels are more frequent than in left colon, which contribute to the difficulty of~     surgery. Among the variations, Henle's trunk is more obvious that makes it the commonest~     cause of bleeding during operation. Several veins can be found to conjoin the Henle's trunk,~     among which ASPDV and REGV are the two common tributaries while RCV,MCV,SRCV may vary from~     people to people. As a result, a better understanding of the anatomical classification of~     Henle's trunk is a must during operation. However, existing studies of Henle's trunk are very~     rare and often single-centered with minimal samples.In order to achieve better surgical~     outcome and reduce operative complications, the investigators design this study to~     investigate the anatomical classification of Henle's trunk and the surgical outcome of each~     type.~   "
15436|NCT03364868|"~     The GPPAD-POInT Study is designed as a randomized, placebo-controlled, double blind,~     multicentre, multinational primary prevention phase IIb study aiming to induce immune~     tolerance to beta-cell autoantigens through regular exposure to oral insulin for a period of~     29 to 32 months. The hypothesis is that regular exposure to oral insulin throughout the~     period in life where beta-cell autoimmunity usually initiates will tolerize against insulin~     and train the body's immune system to recognize the treatment product without reacting~     adversely to it in a manner seen in children who develop T1D. This immune tolerance induction~     therapy would reduce the likelihood of beta-cell autoimmunity. The study objective is to~     determine whether daily administration of oral insulin from age 4 months - 7 months until age~     3.00 years to children with elevated genetic risk for type 1 diabetes reduces the cumulative~     incidence of beta-cell autoantibodies and diabetes in childhood.~   "
15500|NCT03364036|"~     The main purpose of the study is to determine the onset of Mavenclad® action by frequent~     magnetic resonance imaging (MRI) assessment of the combined unique active (CUA) lesions in~     subjects with highly active relapsing multiple sclerosis (RMS).~   "
15437|NCT03364855|"~     Patellofemoral pain syndrome (PFPS) is a common and painful musculoskeletal condition that~     affects physically active young adults and causes pain front of the knee. Patients with PFPS~     has bilateral impairment in proprioception, as well as more in the affected knee than the~     normal; also the decrease of muscular strength, range of motion, and neuromuscular control~     are known to result with impaired static and dynamic balance.This study aimed to investigate~     the efficacy of a-four week YDT balance exercises on pain, quality of life and functional~     state in patients with PFPS with impaired balance.~   "
15438|NCT03364842|"~     in our study the investigators give furosemide during surgery for repair of aortic~     coarctation via lateral thoracotomy and evaluated lung complications in comparison to control~     group~   "
15439|NCT03364829|"~     The effectiveness of combined bronchodilator and exercise training on improving exercise~     capacity has been reported in COPD. However, little is known about effect of respective~     treatment in a real-time monitoring. Investigators applied wearable devices in monitoring~     continuously in COPD patients under treatment of combined dual bronchodilator and exercise~     training and research on associated inflammatory biomarkers profiles change~   "
15440|NCT03364816|"~     To evaluate the efficacy of 3 different types of cervical disc prosthesis (Prodisc-C, Mobi-C~     and Prestige-LP) in the treatment of cervical spondylosis.~   "
15441|NCT03364803|"~     The purpose of this study is to follow participants with Cushing's syndrome during the course~     of their routine care and to form a data registry to study long term participant outcomes.~   "
15442|NCT03364790|"~     The study has before mentioned the concept of knee - spine syndrome domestically, on the~     basement of which, the new study intends to perform another further study on the relationship~     between lumbar and lower extremity degenerative diseases.~   "
15443|NCT03364777|"~     To analyze the correlations between preoperative emotional state and postoperative clinical~     effect among patients undergoing lumbar surgery~   "
15444|NCT03364764|"~     Pure red cell aplasia (PRCA) is a kind of anemia characterized by severe reticulocytopenia~     and obvious bone marrow erythroblastic cells decreased. Cyclosporine and /or steroids are the~     first line therapy but some patients were refractory or intolerance to the treatment. The~     effects of the second line therapy are also not satisfactory and sometimes not available. The~     investigators aim to explore the efficacy and side-effect of sirolimus for refractory PRCA.~   "
15445|NCT03364751|"~     The purpose of this study is to demonstrate in patients with generalized chronic~     periodontitis that switching from cigarette smoking to using IQOS improves the response to~     periodontal therapy and the overall oral health status compared to continuing cigarette~     smoking.~      Note: IQOS is the Tobacco Heating System (THS) with Marlboro Heatsticks, marketed in Japan~     under the brand name IQOS~   "
15446|NCT03364738|"~     This study is open to adults with hypoparathyroidism who complete the SHP634-101 study~     (PARALLAX Study). The purpose of this study is to see if rhPTH(1-84) is safe and effective in~     adults with hypoparathyroidism who previously participated in the SHP634-101 study. All~     participants enrolled in this study will receive rhPTH(1-84) once-daily for 52 weeks via an~     injection.~      Patients who complete the SHP634-101 study will have the option to screen for this extension~     study.~   "
15447|NCT03364725|"~     To demonstrate that colocation treatment of substance use disorder and Hepatitis C infection~     concurrently while proving addiction counselling will achieve increased duration of sobriety~     and elimination of Hepatitis C virus in study participants.~   "
15448|NCT03364712|"~     Background and rationale: B lymphocyte stimulator (BLyS) is a potent B cell survival factor~     that has been found to be elevated in patients with inflammatory conditions, such as systemic~     lupus and rheumatoid arthritis. Because of the immunologic changes associated with pregnancy,~     including changes in levels of T and B lymphocytes, it is postulated that BLyS levels would~     be altered in pregnancy compared to the non-pregnant state.~      Objectives: The primary objective of this study is to assess the levels of BLyS in each~     trimester of pregnancy. Secondary objectives include evaluation of an association between~     BLyS levels and adverse pregnancy events; comparison of BLyS levels between healthy pregnant~     women and pregnant women with a medical or obstetric conditions; and, assessment of APRIL~     levels and comparison between APRIL levels and BLyS levels in study subjects.~      Study population: Pregnant and non-pregnant women receiving care in the outpatient Obstetrics~     and Gynecology clinics at LAC+USC Medical Center.~      Study methodology: Peripheral blood samples will be drawn from pregnant women and~     non-pregnant controls. Pregnant women will have blood drawn each trimester, at delivery, and~     postpartum, and control subjects will have blood drawn once, upon enrollment in the study.~      Study outcomes: BLyS and APRIL levels during each trimester, postpartum and in cord blood~     will be compared between healthy pregnant women, pregnant women with a medical condition, and~     healthy non-pregnant controls. Additionally, pregnancy outcomes will be recorded to determine~     whether BLyS or APRIL levels correlate with adverse events.~      Statistics: Continuous data will be analyzed by Student t-test or logistic regression, where~     appropriate. Categorical data will be analyzed using Chi square.~   "
15449|NCT03364699|"~     The purpose of this study was evaluate the comparative effects of FO rich in EPA (FO-EPA) and~     FO rich in DHA (FO-DHA) on inflammation and neutrophil properties after a prolonged and~     strenuous exercise. The effect of soybean lecithin on the same parameters and conditions also~     was evaluated.~   "
15450|NCT03364686|"~     The purpose of this research is to evaluate the impact of genetic and biologic factors in~     blood donors on red blood cell storage stability after autologous transfusion over the~     different range of storage period of 5-7 days and 35-42 days in healthy volunteers.~   "
15451|NCT03364673|"~     This research study will test whether using wearable fitness trackers with or without a~     social incentive, delivered through a game-based mobile health intervention, increases~     physical activity and quality of life in ovarian cancer survivors.~   "
15501|NCT03364023|"~     The purpose of this post-market registry is to collect real-world data associated with the~     use of Medtronic market-released neurothrombectomy devices in acute ischemic stroke (AIS)~     patients from countries in South East Asia.~   "
15502|NCT03364010|"~     The investigators hypothesize that children with dyslexia present proprioceptive disorders~     and the purpose of the present study is to better understand relationships between motor~     control, proprioception and academic learnings. The investigators compare a group of French~     students with and without dyslexia aged 10-12.~   "
15452|NCT03364660|"~     The investigators propose to understand the role of lumbosacral spinal cord epidural~     stimulation (scES) in recovery of autonomic nervous system function, voluntary movement, and~     standing in individuals with severe spinal cord injury (SCI). Thirty-six individuals with~     severe SCI who have cardiovascular and respiratory dysfunction and who are unable to~     voluntarily move the legs or stand will receive scES for cardiovascular function, voluntary~     movement, or standing with and/or without weight-bearing standing. Training will consist of~     practicing voluntary movements or standing in the presence of specific scES configurations~     designed for the voluntary movements of the legs and trunk (Vol-scES), or epidural~     stimulation configurations specific for standing (Stand-scES). Specific configurations~     epidural stimulation for cardiovascular function (CV-scES) will be provided during sitting~     and supine and during maneuvers of orthostatic or cardiovascular stress. The ability to move~     voluntarily, stand, as well as cardiovascular, respiratory, bladder, bowel and sexual~     function will be assessed in these individuals with chronic severe spinal cord injury.~     Quality of life and costs of health care also will be assessed.~   "
15453|NCT03364647|"~     The purpose of the study is to determine how two different blood flow restriction training~     programs used in conjunction with standard rehabilitation affect leg strength. By doing this~     study, the investigator hopes to learn if one program improves strength and function more~     than the other. The investigator also hope to learn how the training affects the properties~     of muscle in participants who will or have had anterior cruciate ligament (ACL)~     reconstruction. These results will help define how the training programs are working.~      There will be no charge to the participant for their physical therapy visits as long as they~     are part of the study~      The initial visit and follow up assessment at the end of the training will each take up to 6~     hours (2 hours for MRI, 2 muscle biopsy, 2 for muscle strength, movement mechanics and~     questionaires).~      The physical therapy visits will range from 60-120 minutes depending on the participant's~     stage of recovery and the activities to engage in. Training sessions will be held 3 days a~     week for approximately 4 weeks before surgery and up to 24 weeks after surgery. There will be~     a total of 4 additional study visits over a 7 month period. The first visit will be used to~     capture baseline conditions of their knee and thigh muscles (muscle biopsy, MRI, strength).~     The second visit will occur right before surgery to assess changes during prehabilitation~     (strength and walking mechanics). The third visit will occur 4-5 months after surgery and~     will be a complete reevaluation of their thigh muscle and knee function (muscle biopsy, MRI,~     strength, gait). The last visit will occur 6-7 months after surgery and will involve an~     assessment of their thigh muscle strength, walking, and jumping form.~      The muscle biopsy and magnetic resonance imaging portion of the study will occur in the~     outpatient unit of the Center for Clinical and Translational Science at the UK Medical Center~     and the MRI center located on the medical center campus. The muscle biopsy will take an~     additional 15 minutes and the MRI up to two hours (1 hour per leg). It can take up to 4 hours~     total to complete both procedures. The investigator will accommodate participant preference~     for scheduling.~   "
15454|NCT03364634|"~     Observational study to investigate the natural course of intracranial pressure (ICP) after~     decompressive craniectomy (DC) using long-term telemetric ICP monitoring. Patients will have~     continuous ICP measurement performed during the admission to the neuro-intensive care unit~     (NICU) and after discharge weekly measurements sessions will be performed before and after~     cranioplasty.~   "
15455|NCT03364621|"~     This is a prospective study investigating the disease course of patients with colorectal~     cancer that have had their cancer spread to their liver. The aim of this study is find~     potential biomarkers for disease recurrence and therapeutic targets for prognostic~     information.~   "
15456|NCT03364608|"~     This is a randomized, double-blind, single-dose, placebo-controlled, 5-period, 5-treatment,~     crossover, multi-center study to assess the bronchodilatory effect and safety of 2 dose~     levels of Albuterol Sulfate Pressurized Inhalation Suspension (hereafter referred to as AS~     MDI), 90 μg and 180 μg, compared with placebo for AS MDI (hereafter referred to as Placebo~     MDI) and open-label Proventil® hydrofluoroalkane (HFA; hereafter referred to as Proventil) 90~     μg and 180 μg in adult and adolescent subjects with mild to moderate asthma. This study~     design utilizes 10 treatment sequences.~   "
15457|NCT03364595|"~     To compare the effect of Operative Plate Fixation Versus Replacement for Mason Type III~     Fracture of Radial Head~   "
15458|NCT03364582|"~     Colorectal cancer (CRC) is the third most commonly diagnosed cancer in American men and women~     with ≥130,000 new cases each year. Several dietary patterns have been associated with CRC~     risk but underlying mechanisms are not fully understood. Researchers thus propose to~     integrate dietary patterns and metabolomics data to comprehensively investigate biological~     pathways linking dietary patterns and CRC risk.~   "
15459|NCT03364569|"~     Tranexamic acid (TXA), as an antifibrinolytic agent, has shown a tremendous interest in~     surgery by reducing blood loss ; but only few articles have been reported in the plastic~     surgery scope. The aim of this study was to investigate whether oral administration of TXA~     reduces surgical drainage in primary breast augmentation using implants.~   "
15460|NCT03364556|"~     Celiac disease leads to malnutrition and secondary conditions including osteoporosis. The~     dietary habits of adults with untreated, undiagnosed celiac disease has not yet been~     observed, but presents a critical piece in understanding the effects of the disease on bone~     health. Objective was to evaluate differences in nutritional intake of calcium, vitamin D,~     and phosphorus; serologic indices of these nutrients; and bone health among adults with and~     without celiac disease. Cross-sectional data from What We Eat in America (WWEIA) and the~     National Health and Nutrition Examination Survey (NHANES) 2009-14 was analyzed.~   "
15461|NCT03364543|"~     The purpose of this study is to assess the acceptability, feasibility, and preliminary~     effectiveness of the UTHealth medical-legal partnerships (MLP) against usual care.~   "
15462|NCT03364530|"~     We hypothesized that intra-arterial gemcitabine/oxaliplatin administered as second-line~     treatment could strongly improve objective response rate at 4 months after inclusion in~     patient with non-metastatic unresectable intra-hepatic cholangiocarcinoma.~   "
15463|NCT03364517|"~     The purpose of this study is to prospectively evaluate a standardized procedure of medical~     regulation based on a validated predictive score of eminent delivery (SPIA) in comparison~     with usual inhomogeneous practices. This standardized procedure impacting the process of care~     production (when receiving the call for regulation for unannounced delivery) would improve~     the quality of care of parturients while rationalizing the use of medical teams in the field.~   "
15464|NCT03364504|"~     Our objective is to obtain human induced pluripotent stem cells from urine samples of PXE~     patients for further proteomic and metabolomic studies and treatment screening.~   "
15465|NCT03364491|"~     A randomized placebo-controlled trial of 11,000 women to assess whether tranexamic acid as~     prophylaxis lowers the risk of postpartum hemorrhage in women undergoing a cesarean delivery.~   "
15466|NCT03364478|"~     To standardize the surgery for advanced right hemi colon cancer with laparoscopy and~     investigate whether dorsal and medial hybrid approach could improve disease-free survival in~     patients with right colon cancer, compared with traditional medial-to-lateral approach in~     laparoscopic righ hemicolectomy.~   "
15467|NCT03364465|"~     During One-lung ventilation, the use of lower tidal volumes (VT) is helpful to avoid~     over-distension, provide sufficient oxygenation, but can result in increased atelectasis.~      Nevertheless, it is not known if, during one-lung ventilation with constant low VT, moderate~     levels of PEEP combined with lung recruitment maneuvers are superior to variable low tidal~     volume for intraoperative oxygenation and protection against PPCs.~      Aim of the study is to compare a strategy using constant tidal volume with recruitment~     maneuvers versus variable tidal volume with recruitment maneuvers during thoracic surgery in~     adults.~      We hypothesize that in adult, non-obese patients undergoing thoracic surgery under~     standardized OLV with variable tidal volumes, modearte PEEP and recruitment maneuvers as~     compared to constant without recruitment maneuvers prevent PPCs.~      Patients will be randomly assigned to one of two groups:~      FIX TIDAL VOLUME GROUP (Groupfix): mechanical ventilation with constant (6 ml/kgIBW) tidal~     volume and PEEP of 5 cmH2O with recruitment maneuvers~      VARIABLE TIDAL VOLUME GROUP (Groupvar): mechanical ventilation with variable (6 ml/kgIBW ±~     33%) tidal volume with variable respiratory rate to maintain constant minute ventilation and~     PEEP of 5 cmH2O with recruitment maneuvers.~   "
15468|NCT03364452|"~     The purpose of the study is see how well two dietary intake questionnaires, blood values, and~     urine samples can estimate what participants are eating and drinking. Specifically, the~     investigators are looking at the validity of a new artificial sweetener food frequency~     questionnaire and a urinary biomarker for artificial sweetener consumption. Additionally, the~     investigators are examining the ability of a rapid beverage intake questionnaire (BEVQ-15) to~     determine Healthy Beverage Index scores.~   "
15469|NCT03364439|"~     Prospective, multicentre phase II study with R-CHOP- 14 or R-CHOP-21 & consolidation~     PET-oriented radiotherapy (RT) in diffuse large B cell lymphoma (DLBCL) patients~   "
15470|NCT03364426|"~     Child stunting remains an important global health issue, with 157 million children under five~     years of age estimated to be stunted in 2014. Until recently, stunting was thought to occur~     in the first 1000 days of life (between conception and 2 years of life), and was thought to~     be largely irreversible thereafter. However, emerging research suggests that children can~     transition between stunted and non stunted status up to 15 years of age, with studies also~     suggesting potential implications in terms of cognitive status. Despite this, there is little~     research on stunting and its potential determinants among children of older ages, with most~     current studies confined to those under five. This study aims to assess the prevalence of~     stunting and examine potential sociodemographic determinants of stunting (including~     individual, maternal and household level indices) among older children (aged 6-19 years) in a~     Malaysian population.~   "
15471|NCT03364413|"~     The purpose of this study is to test how the brain responds when individuals eat enjoyable~     foods such as chocolate. Eating certain foods can make one want to keep eating even when~     feeling full, caused by dopamine in the brain. The researchers believe this dopamine response~     can be measured by looking at the individual's eye.~   "
15472|NCT03364400|"~     This study is an an open-label Phase I trial of VT1021 in patients with advanced solid~     tumors. Patients must have recurrent or advanced cancer (i.e., solid tumors) for which~     standard therapy offers no curative potential.~   "
15473|NCT03364387|"~     The objective of this study is to analyze the Demographics, Clinical Profiles, Management,~     in-Hospital and Long-Term Outcomes of Patients with Acute Coronary Syndrome Syndrome And~     Myocardial Infarction with Non-obstructive Coronary Artery Disease.~   "
15474|NCT03364374|"~     This study evaluates the relationship between seated posture and fine motor performance in a~     drawing task in people with stroke and in healthy control subjects.~   "
15475|NCT03364361|"~     Introduction: Although the physiologic response to stress is necessary for mammals to~     survive, prolonged stress response as a result of perceived stress can lead to allostatic~     load and loss of resilience to future stressors. To mitigate the consequences of allostatic~     load, researchers have investigated the effects of acupuncture as a promising intervention.~      Objectives/Aims: The purpose of this study is to explore the feasibility and effect of a~     standardized stress acupuncture (SSA) approach on perceived stress in U.S. military~     personnel. Specific aims include the following: a) to determine feasibility of recruitment~     for SSA and implementation of study procedures in preparation for a methodologically rigorous~     study, b) to determine the acceptability of SSA treatment in a sample of military personnel~     with perceived stress, and c) to assess perceived stress and general health before and after~     SSA.~      Methods and Analysis: This is a single-arm, single-site study protocol to assess feasibility~     of SSA in a total of 15 patients with perceived stress. Upon IRB approval and written~     informed consent, the participants will receive 4 weekly sessions of SSA which consists of 6~     acupuncture points. Demographic information and attrition of participants will be monitored~     throughout the study. Patient-reported questionnaires including Acupuncture Expectancy Scale,~     Perceived Stress Scale, and SF-36 will be administered at baseline and then at the completion~     of the study. Descriptive statistics, reliable change indices (RCI), and Wilcoxon~     Signed-Ranks tests will be conducted to assess the magnitude of changes in scores.~      Military Relevance: The three most common disability conditions in the military include~     musculoskeletal, psychiatric, and neurological body systems. Among these problems, however,~     mental health disorders remain a significant contributor to disability and suicide. Given the~     role of perceived stress in disability and suicidality in the military, intervening early~     before service members become at risk for severe injuries, hospitalizations, and chronic~     disability could help decrease burdensome problems.~   "
15476|NCT03364348|"~     This trial studies the best dose and side effects of utomilumab (4-1BB agonist monoclonal~     antibody PF-05082566) with trastuzumab emtansine or trastuzumab in treating patients with~     HER2-positive breast cancer that has spread to other places in the body. Monoclonal~     antibodies, such as utomilumab, trastuzumab emtansine, and trastuzumab may interfere with the~     ability of tumor cells to grow and spread.~   "
15477|NCT03364335|"~     This is a 24-week study to evaluate the effects of two fixed-dose combinations of leucine and~     sildenafil or two fixed-dose combinations of leucine, sildenafil and metformin compared to~     placebo. The primary objective of this study is to evaluate the percentage change in body~     weight in subjects from Baseline/Visit 2 (Day 1) to Study Termination/Visit 8 (Day 168/Week~     24).~   "
15478|NCT03364322|"~     Dry eye syndrome and ocular surface disease are very important ophthalmologic diseases. It is~     known that various inducers are involved. However, it is still necessary to study how~     influencing factors are related to dry eye syndrome and ocular surface disease and how~     treatment for dry eye syndrome and ocular surface disease is helpful.~   "
15479|NCT03364309|"~     The purpose of this study is to determine the efficacy and safety of the study drug~     ixekizumab in Chinese participants with moderate-to-severe plaque psoriasis.~   "
15480|NCT03364296|"~     The FLAG1 study will assess the diagnostic performance of biomarkers Glutathion~     S-Transferase-π (GST-π) and Peroxyredoxin 1 (PRDX1) to identify cerebral infarction of less~     than 4,5 hours in a population of patients with neurological deficiency of less than 12~     hours.~   "
15482|NCT03364270|"~     The purpose of this study is to investigate the ability of a new investigational agent~     compound [F-18] labeled RGD-K5 to detect unstable atherosclerotic plaque in the carotid~     artery of subjects being considered for carotid endarterectomy (CEA), and to confirm this~     ability through tissue analysis of samples of carotid artery plaques that will be collected~     during the planned carotid surgery. [F-18] RGD-K5 is a radioactive tracer used in imaging to~     detect active growth of new blood vessels and presence of macrophages. Patients with unstable~     plaque may be prone to rupture of the plaque due to increase in macrophage activity and~     growth of new blood vessels. [F-18] RGD-K5 is an investigational agent, which means that it~     has not yet been approved by the US Food and Drug Administration (FDA).~      Unstable atherosclerotic plaque that is prone to rupture is characterized by an increase in~     the number of macrophages and enhanced angiogenesis. Both neovascular endothelium and~     macrophages exhibit increased Alpha-v beta3 integrin expression. PET (Positron Emission~     Tomography) imaging of [F-18] RGD-K5 uptake may identify carotid plaque with increased~     inflammation and neovascularization and may therefore detect unstable plaque in participants~     with carotid artery stenosis.~      Prior to Dr. Tamarappoo's relocation to Cedars Sinai Medical Center (CSMC), 5 subjects were~     enrolled at the Cleveland Clinic where PET-CT (Positron Emission Tomography - Computed~     Tomography) was performed. 6 subjects will be scanned at Cedars using PET-MRI (Positron~     emission tomography-magnetic resonance imaging). Based on preliminary data with PET-CTA, the~     investigator strongly believes the study will be able to reproducibly detect significant~     [F-18] RGD-K5 uptake in plaque from symptomatic patients. Ultimately, demonstrating~     preferential [F-18] RGD-K5 uptake in symptomatic patients will significantly impact the way~     in which patients with carotid plaque (at risk for stroke) are treated and it may prevent~     unnecessary surgical and endovascular procedures in this population~   "
15483|NCT03364257|"~     Prospective, multicentre French observational study assessing the performance and~     medico-economic utility of iDTECT Blood versus conventional microbiologic diagnosis in~     patients with febrile neutropenia~   "
15484|NCT03364244|"~     Secondary data collection study: safety and effectiveness of Revatio in pediatric patients~     under Japanese medical practice~   "
15485|NCT03364231|"~     This research study will evaluate the safety and efficacy of a study drug called Umbralisib~     (also known as TGR-1202) alone as a possible treatment for Waldenstrom's Macroglobulinemia~     and Marginal Zone Lymphoma that has come back or that has not responded to standard~     treatment.~   "
15486|NCT03364218|"~     Bronchiolitis is the major cause of hospital admission in infants under 6 months of age and~     usually viruses like Respiratory syncytial virus (RSV), human metapneumo virus, Adeno virus,~     para-influenza virus, Rhino virus and influenza virus are the main culprit. In the United~     States, acute bronchiolitis in infancy is responsible for approximately 150000~     hospitalizations each year at an estimated cost of $500 million. Globally in 2005 year it is~     estimated that atleast 33.8 million were affected with RSV alone and in the same year, RSV~     associated severe acute lower respiratory infection (ALRI) were responsible for ~3.4 million~     hospitalizations and 66000 to 199000 deaths worldwide, with 99% of these deaths occurring in~     developing countries.~      In acute bronchiolitis there is cellular swelling and excessive mucus production. There is~     also proliferation of goblet cells, which also leads to increased mucus production. The~     excessive mucus produced is poorly cleared by non-ciliated (regenerating) epithelial cells~     leading to areas of narrowing and blocking of the bronchioles, causing the airway~     obstruction, hyperinflation, increased airway resistance, atelectasis and increased~     ventilation-perfusion mismatch that characterize acute bronchiolitis.~      Currently there is no medicine that has shown to be effective in treating acute bronchiolitis~     and as per the American Academy of Pediatrics guidelines the management of acute~     bronchiolitis remains supportive care for the acute respiratory failure associated with acute~     bronchiolitis.~      N-Acetyl Cysteine (NAC) is an antioxidant, anti-mucus compound that increases intracellular~     glutathione at the cellular level. It cleaves disulfide bonds by converting them to two~     sulfhydryl groups. This action results in the breakup of mucoproteins in lung mucus, reducing~     their chain lengths and thinning the mucus. Nebulized NAC is not studied well in acute~     bronchiolitis and is uncommonly used for the same. NAC has been studied in the treatment of~     various disease states, including those pulmonary in nature such as cystic fibrosis, chronic~     bronchitis, non-cystic fibrosis bronchiectasis and found to be beneficial.~      With this background knowledge, the purpose of this study is to evaluate the effectiveness of~     nebulized mucolytic therapy in treatment of children with viral bronchiolitis. Currently~     there is only one study in literature by Naz F et el published in 2014 where nebulized NAC~     with nebulized Albuterol in acute bronchiolitis and it showed significant improvement in~     clinical severity scores as documented in that study~   "
15487|NCT03364205|"~     Aims-objectives: This study assessed the effect of the Solution Focused Approach (SFA)~     interview technique on overweight/obese adolescents' nutrition-exercise attitudes and~     behaviors.~      Background: Obesity is a serious health problem for all age groups, particularly adolescents;~     therefore, it is important for adolescents to develop healthy nutrition habits, acquire~     exercise behaviors. Unless healthy nutrition-exercise behaviors are acquired, obesity can~     develop in adolescence, continue in adulthood. Focusing on solutions can be effective for~     overweight/obese adolescents to develop healthy nutrition-exercise behaviors.~      Design: A pretest-posttest randomized-controlled trial design was used.~      Methods: The study included 32 overweight/obese adolescents (16 for intervention group, 16~     for control group) aged12-13 years who attended a health center, met the inclusion criteria.~     The SFA interview technique was applied to the intervention group. Eight solution-focused~     interviews were conducted with each adolescent at two-week intervals (interview length 30 to~     45minutes). For each group, anthropometric, metabolic measurement follow-ups were conducted~     in the first and sixth months. The data were evaluated using independent samples t-test,~     Mann-Whitney U, Wilcoxon test respectively for normally, non-normally distributed variables.~     The categorical variables were compared using chi-square test. The value p<0.05 was accepted~     to be statistically significant.~   "
15488|NCT03364192|"~     The investigators are evaluating a service called peer-delivered Whole Health Coaching to~     understand how it can help Veterans with PTSD. This project has two main goals: (1) determine~     how peer-delivered Whole Health Coaching can help Veterans with post-traumatic stress~     disorder and (2) learning about feasibility of implementing this service in Veterans Health~     Administration primary care settings. The investigators are also evaluating feasibility of~     the research methods in this trial to learn how to improve future studies on this topic.~      Whole Health Coaching is a service designed to improve health and wellness. It is a variation~     of integrative health coaching and is being used in Veterans Health Administration medical~     centers. In Whole Health Coaching, Veterans will work with coaches to develop a personal~     health mission, develop specific goals and action steps, and then adjust their plan as~     needed. Coaches provide guidance and support throughout the process. In this project, a peer~     support specialist working in primary care will be the coach. VA Peer Support Specialists,~     peers, are Veterans recovering from a mental health condition trained to help other~     Veterans improve their health.~      All participants will receive peer-delivered Whole Health Coaching. Participants will be~     randomly assigned a start date for their first session with the Peer Whole Health Coach~     between 4 and 13 weeks after they start the study. The information provided during this time~     prior to the first session helps us understand how participants do on their own without the~     service. The research components include interviews and questionnaires about health and~     wellness, goals, and experiences with the service. Veterans who participate in the study will~     complete short questionnaires twice a week for 6 months and have four longer appointments~     where more questions will be asked. Participants will also be given the opportunity to~     provide feedback on the service.~   "
15503|NCT03363997|"~     This clinical trial evaluated the pharmacokinetics and pharmacodynamics of estriol in healthy~     post-menopausal women after the application of one vaginal ring containing one of three~     different dosages of estriol (100 mg (Test 1), 300 mg (Test 2) or 600 mg (Test 3)) with~     continuous delivery (0.125, 0.250 or 0.500 mg/day) for 21 days. And also, characterized its~     safety and tolerability.~   "
15504|NCT03363984|"~     A clinical study in healthy male subjects to investigate whether the administration of ID-082~     can affect the fate in the body (amount and time of presence in the blood) of midazolam.~   "
20393|NCT03300050|"~     The clinical study will evaluate safety and the immune response of a prime- boost regimen~     with a live attenuated influenza vaccine (LAIV) prime and an inactivated split influenza~     vaccine (IIV) boost with or without adjuvant.~   "
15489|NCT03364179|"~     From a scientific view, palliative care issues in dementia are neglected in Germany. Neither~     in Germany nor internationally research has been conducted on palliative care issues in young~     onset dementia (YOD), although significant differences compared to late onset dementia (LOD)~     are expected. Most international studies have focused on patients in long term care (LTC)~     facilities but have neglected patients that are cared for at home. We hypothesize that in~     advanced and terminal stages of YOD and LOD unmet care needs exist and that they differ~     between YOD and LOD. By prospectively assessing and surveying 200 patients with YOD and LOD~     in advanced stages who are cared for in LTC facilities and at home and investigating~     circumstances of death of 100 YOD- and LOD-patients, it is possible 1) to describe symptoms~     and management, health care utilization, palliative care provision, quality of life and~     death, elements of advance care planning, family caregivers' needs and satisfaction; 2) to~     compare YOD and LOD; 3) to develop expert-consensus recommendations derived from study~     results for the improvement and implementation of strategies and interventions for palliative~     care provision. 4) to communicate the recommendations nationally and internationally in order~     to improve and adapt guidelines, to implement the recommendations into daily practice and to~     give a basis and perspectives for future research projects; to communicate the results to~     patients and their families in order to counsel and support them in their decision making~     processes and their dialogue with professional caregivers and physicians.~   "
15490|NCT03364166|"~     Evaluation of local control in buccinator muscle excision with the skin versus buccinator~     muscle excision without the skin in buccal squamous cell carcinoma: A randomized clinical~     trial.~   "
15491|NCT03364153|"~     To evaluate the safety and efficacy of Zimura™ (complement factor C5 inhibitor) compared to~     Sham in subjects with autosomal recessive Stargardt disease 1 (STGD1).~   "
15492|NCT03364140|"~     Peripartum cardiomyopathy (PPCM) is a global disease with significant morbidity and mortality~     of young women. Its' etiology, epidemiology and treatment is not yet well described. This~     will be a retrospective, national, multicenter observational study, conducted in Turkey. It~     is expected that approximately 50 women with PPCM will be recorded.~   "
15493|NCT03364127|"~     This study evaluates acupuncture for the treatment of vulvodynia; specifically if it reduces~     vulvar pain and pain with intercourse. It also examines how long the effect of acupuncture~     lasts in women with vulvodynia. Half of the women will receive acupuncture and the other half~     will receive placebo acupuncture. Women who get a reduction in pain will monitor there pain~     once a week for up to 12 weeks to see how long the acupuncture effect lasts.~   "
15494|NCT03364114|"~     The aim of the clinical trial is to evaluate the EndoRotor®'s ability to completely remove~     areas of Barrett's metaplasia considered refractory after 3 failed radiofrequency ablations~     (RFA).~   "
15495|NCT03364101|"~     The primary objective is to explore the relationship between experimental condition (placebo~     or PowerOff) and sleep quality between pre-study and post-study. In addition, volunteers will~     wear actigraphy watches that collect objective measures of sleep, such as total sleep time,~     and these data points will be compared pre- and post-study.~   "
15496|NCT03364088|"~     Previous retrospective database studies suggest that total knee arthroplasty (TKA) surgery~     under spinal anesthesia has less complications than when performed under general anesthesia.~     In general, complications are rare and both anesthesia types are widely accepted. In Finland,~     total knee arthroplasty has typically been performed under spinal anesthesia.~      In a recent prospective randomized controlled study, total knee arthroplasty under general~     anesthesia resulted in less acute postoperative pain (opioid-need measured by~     patient-controlled anesthesia), less nausea, and faster hospital discharge than that~     performed under spinal anesthesia. Also the use of surgical tourniquet can affect surgical~     outcome: it may reduce bleeding and surgery time, but it may also cause weakness of thigh~     muscles and thus hinder mobilization. In a recent study, both techniques with and without~     surgical tourniquet appeared equal.~      The aims of this study are to compare total knee arthroplasty under spinal or general~     anesthesia, with or without surgical tourniquet, in relation to acute and chronic~     postoperative pain, nausea, knee function, patient reported quality of life and satisfaction~     on care, complications, length of stay, and need of surgical unit resources. This randomized~     controlled study includes 400 patients with informed consent, 18-75-years-of-age, standard~     primary total knee arthroplasty operation, American Society of Anesthesiologist (ASA)~     physical status classification I-III, body mass index under 40, and no contraindications for~     medications or treatments used.~      The hypothesis of this study are used to reassess best practices of primary total knee~     arthroplasty operation to enhance quality of care, patient outcomes and satisfaction, and~     availability of surgery due to better patient flow at surgical unit.~   "
15497|NCT03364075|"~     This study is a randomized, double-blind, placebo controlled, three period crossover clinical~     trial. The main purpose of this study is to determine if Chronic Low Back Pain patients~     presenting with either localized or widespread painful symptoms respond differently to~     treatment with Duloxetine or Propranolol, and if the effectiveness of treatment with these~     drugs can determined by the presence or absence of SNPs associated with the Serotonin~     receptor or Cathecol-O-MethylTransferase activity. Each treatment period will be of two weeks~     duration with a 1 week washout phase between treatment periods. Following a Latin square~     design, patients will be randomly assigned to one of six different treatment groups, starting~     their first treatment cycle with either Duloxetine, Propranolol or Placebo and rotating~     through the other treatments in the subsequent cycles. Effectiveness of treatment will be~     measured by means of Pain Index as the primary outcome measure, and secondary outcome~     measures will include Pressure Pain Threshold and the Pain Disability Index, Perceived Stress~     Scale, Symptom Checklist -90R and the Patient's Global Impression of Change questionnaires.~   "
15498|NCT03364062|"~     To clarify the downward trend of blood pressure affected by bone cement implantation during~     shoulder replacement operations.~   "
15499|NCT03364049|"~     The purposes of this study are to: 1) determine the safety and tolerability of MK-7162 when~     administered in combination with pembrolizumab (MK-3475), 2) establish a preliminary~     recommended Phase 2 dose (RP2D) of MK-7162 when administered in combination with~     pembrolizumab, and 3) assess the pharmacokinetics and pharmacodynamics of MK-7162 when~     administered in combination with pembrolizumab and other therapies to adult participants with~     advanced solid tumors.~   "
15505|NCT03363971|"~     Zhi Kang Capsule functions for hemostasis and detumescence and can be used for traumatic~     bleeding, uterine bleeding, hematemesis and hematochezia.This randomized controlled trial was~     conducted to confirm the efficacy and safety of Zhi Kang Capsule in the treatment of~     posttraumatic swelling and pain,and also in a wide range of applications by open clinical~     observation.~   "
15506|NCT03363958|"~     This study evaluates the addition of remote ischemic preconditioning and postconditioning to~     standard myocardial protection protocol in patients submitted to off - pump coronary artery~     bypass grafting in a prospective, 1:1 randomized, double blind fashion. An interventional~     group will receive remote ischemic preconditioning 24-hours before OP-CABG, immediately~     before surgery and within 60 minutes following surgery by means of lower limb ischemia~     achieved by pressure cuff inflation, whereas control group will receive sham procedure~     perioperatively.~   "
15507|NCT03363945|"~     The primary objective of this study is to demonstrate the safety and efficacy of cellular~     immunotherapy with MDR-101 for induction of functional immune tolerance in recipients of~     human leukocyte antigen (HLA)-matched, living donor kidney transplants.~   "
15508|NCT03363932|"~     Ventricular septal defects (VSD) are the most common cardiac congenital heart defect (about~     1/3 of patients with congenital heart disease). VSD management is related to hemodynamics and~     anatomical localization and the occurrence of complications. Small perimembranous VSD without~     pulmonary hypertension and without significant left to right shunting are tolerated, whereas~     large VSD with pulmonary hypertension require early surgical management in the first months~     of life. The management uncertainties concern the medium-sized perimembranous VSD causing a~     significant left-right shunt but without pulmonary hypertension, which are of variable~     treatment (surgical correction, percutaneous treatment, medical or abstention). There are no~     recommendations or consensus on the preferred indication of a therapeutic attitude.~      The Pediatric and Congenital Cardiology Subsidiary, within the French Society of Cardiology,~     set up an observatory of perimembranous VSD with significant shunting, without pulmonary~     hypertension the objectives of this study are:~        -  To study the incidence of cardiovascular events in perimembranous VSD and search for~          predictive anatomical markers of events.~        -  To study the evolution of echocardiographic and functional data of patients having~          percutaneous or surgical closure compared to patient managed medically.~      This observatory will provide a better understanding of the therapeutic algorithm in the~     management of VSD with pulmonary overload without pulmonary hypertension.~   "
15509|NCT03363919|"~     The Researchers are going to gather information regarding the use of rTMS as a treatment for~     depression in adolescents with Major Depressive Disorder. The researchers also hope to learn~     if measures of brain activity (cortical excitability and inhibition) collected with~     transcranial magnetic stimulation (TMS) can be used to identify which patients will benefit~     from certain types of rTMS treatment.~   "
15510|NCT03363906|"~     The purpose of this study is to evaluate a new formulation of dulaglutide (study drug)~     administered under the skin as one injection using a single dose pen compared to three~     injections using a pre filled syringe.~      This study will evaluate how much of the study drug enters the body and how long it takes the~     body to get rid of it. Information about any side effects that may occur will also be~     collected.~      The study will last about 84 days, including screening and will require overnight stays in~     the clinical research unit (CRU).~   "
15511|NCT03363893|"~     This study is of a modular study design allowing an investigation of the optimal monotherapy~     dose and combination doses of CT7001 with other anticancer treatments with intensive safety~     monitoring to ensure the safety of the patients. Module 1 (monotherapy) will be performed~     initially, with further modules added at a later date as protocol amendments.~   "
15512|NCT03363880|"~     To evaluate the effects of trauma treatment team establishment on the treatment of patients~     with severe trauma.~   "
15513|NCT03363867|"~     Epithelial ovarian cancer (EOC) is the ninth most common cause of cancer in Australian women,~     with an estimated 1500 new diagnoses in Australia in 2015, and remains the seventh most~     common cause of cancer death in Australian women. High grade serous ovarian cancer (HGSC) is~     the most common form of Epithelial Ovarian Cancer, and accounts for the most deaths due to a~     gynaecological cancer.~      The majority of women diagnosed with High Grade Serous Ovarian Cancer present with advanced~     disease, and are typically managed with a combination of cytoreductive surgery and~     platinum-based chemotherapy. Despite initial good response rates to chemotherapy, High Grade~     Serous Ovarian Cancer recurs in up to 70% of patients who present with Stage III/IV disease.~      The molecular characteristics of High Grade Serous Ovarian Cancer have recently been~     extensively described in multiple studies. One of the consistent features identified are four~     distinct molecular subtypes that are based on gene expression profiles.These four subtypes~     are associated with differential clinical outcome that are largely consistent across multiple~     datasets. The subtypes may also be predictive for benefit from certain types of treatment.~      The C1 or mesenchymal subtype is pathologically characterised by an excessive fibrotic~     response of the stroma surrounding tumours, a process that is collectively referred to as~     desmoplasia. Patients with C1 High Grade Serous Ovarian Cancer have an increased incidence of~     primary treatment failure and poor overall survival (OS).~      The purpose of this research project is to test how safe and effective the combination~     treatment of cobimetinib, bevacizumab and atezolizumab is as a treatment for patients with a~     C1 subtype of platinum resistant or refractory ovarian, fallopian tube or peritoneal cancer.~      Cobimetinib is a drug that blocks a protein called Mitogen-activated protein kinase (MEK).~     MEK proteins are involved in the multiplication of cancer cells. By binding to the MEK~     protein, cobimetinib may help to stop the growth of your cancer cells.~      Bevacizumab is an antibody (a type of protein produced by the immune system) that is~     specifically designed to block a protein called Vascular Endothelial Growth Factor (VEGF).~     VEGF is a protein that can increase the growth of tumour cells and binding to VEGF may help~     to stop the growth of tumours.~      Atezolizumab is a type of drug called a Programmed Cell Death Protein 1 (PD-L1) inhibitor.~     PD-L1 binds to PD-1 which is a type of protein found on the surface of cells in your body's~     immune system, and it controls the ability of your body's natural immune response to trigger~     the death of tumour cells. Tumour cells can hide from the immune system by using PD-L1, which~     stops your immune system from triggering tumour cell death.~      Atezolizumab is a drug designed to block this PD-1/PD-L1 interaction by binding to PD-L1 so~     that PD-1 cannot bind to it and stops it from turning off your immune cells. This helps your~     immune system to recognise and destroy tumour cells. In turn, this potentially can stop or~     reverse the growth of your cancer.~      Cobimetinib, bevacizumab and atezolizumab have been used alone or in combination in the~     treatment of many other cancers. Each of them are individually licensed for the treatment of~     cancers such as advanced melanoma, non-small cell lung cancer, and bladder cancer in~     Australia. However, this treatment combination is experimental and is not approved to treat~     ovarian, fallopian tube or peritoneal cancers in any country.~   "
15514|NCT03363854|"~     Primary objective:~      To demonstrate that tralokinumab in combination with topical corticosteroids (TCS) is~     superior to placebo in combination with TCS in treating moderate-to-severe atopic dermatitis~     (AD).~      Secondary objectives:~      To evaluate the efficacy of tralokinumab in combination with TCS on severity and extent of~     AD, itch, and health-related quality of life compared with placebo in combination with TCS.~      To assess the safety of tralokinumab in combination with TCS when used to treat~     moderate-to-severe AD for 32 weeks.~   "
15515|NCT03363841|"~     This is a multicenter, open-label, non-comparator, single-arm study to evaluate the efficacy,~     safety, tolerability and PK (pharmacokinetics) of oral SCY-078 as an emergency use treatment~     for patients with a documented Candida auris infection.~   "
15516|NCT03363828|"~     The investigators aim to examine the endometrium with state of the art sequencing techniques~     to investigate the endometrial microbiota. The endometrial microbiota has been perceived to~     be sterile, however, this seems incorrect from recent studies. Thus, the primary outcome is~     to compare the rate of ascending infection from the semen to the vagina to the endometrium~     and to investigate which bacteria are capable of inhabiting these environments. Furthermore,~     cervical mucus will be obtained in order to test for immunological, microbiological and~     mechanical properties that may be involved in ascending infection. Finally, the study aim to~     characterize the temporal changes in the vaginal microbiota during estrogenic treatment with~     Estrofem® or Vivelle Dot (R) for preparation of the endometrium prior to embryo transfer.~   "
15517|NCT03363815|"~     This is a four-part study to evaluate the effect of multiple doses of CC-90001 on the PK,~     safety, and tolerability of single doses of omeprazole, midazolam, warfarin, rosuvastatin,~     metformin, digoxin, and nintedanib in healthy subjects. Each study part is a nonrandomized,~     fixed-sequence, open-label, two-period study. The study parts can be run in any order and can~     be, but do not have to be, run in parallel. Subjects may participate in one part only. For~     each part, each subject will participate as follows:~        -  Screening (Days -21 through -2)~        -  Baseline phase for each study period (Periods 1 and 2)~        -  Treatment phase for each study period (Periods 1 and 2)~        -  Follow-up telephone call~   "
15518|NCT03363802|"~     Assessment of Pubertal Growth Spurt in Growing Egyptian Females Using Modified Middle Phalanx~     of The Middle Finger Stages and Its Correlation With Development Stage of Mandibular Second~     Molar~   "
15519|NCT03363789|"~     The purpose of this study is to compare the effectiveness of ultrasound guided brisement,~     brisement without ultrasound guidance and standard conservative treatment in patients who~     have been diagnosed with Achilles tendinosis. We are asking you to take part in this research~     study because you are a patient of the Brigham Foot and Ankle Clinic who has been diagnosed~     with Achilles tendinosis. About 100 people will take part in this research study, all at~     Brigham and Women's Hospital (BWH).~      To our knowledge, there has been very little research in the efficacy of the addition of~     briesment injections to standard, conservative treatment of Achilles tendinosis. We hope our~     results will show which method is the most effective conservative treatment for Achilles~     tendinosis. This information will help doctors make decisions in the future.~   "
15520|NCT03363776|"~     The purpose of this study is to investigate experimental medication BMS-986277 given alone~     and in combination with Nivolumab in patients with epithelial cancers.~   "
15521|NCT03363763|"~     The objective of this study is to evaluate the safety and efficacy of sirolimus (0.2% and~     0.4% formulations) and its vehicle when applied topically once daily for 12 weeks for the~     treatment of cutaneous angiofibromas in pediatric subjects with tuberous sclerosis complex~     (TSC).~   "
15522|NCT03363750|"~     The Center for Mind -Body Medicine has developed a mind-body skills group program that~     incorporates meditation, guided imagery, breathing techniques, autogenic training,~     biofeedback, genograms, and self-expression through words, drawings, and movement. These~     mind-body skills are designed to increase self-awareness and self-regulation. This program~     has been shown to significantly improve depression symptoms in children and adolescents with~     posttraumatic stress disorder in Gaza, but it has not yet been tested in a US adolescent~     population. The purpose of this study is to determine the feasibility of using mind-body~     skills groups to reduce depression in adolescents and to investigate the effects of the~     program on factors such as self-efficacy, mindfulness and rumination which are likely to~     mediate improvement.~   "
15523|NCT03363737|"~     Examine the utility of the Transtheoretical Model in influencing anxiety among college~     students. Employ a randomized controlled intervention including a static and dynamic Facebook~     intervention. The static group accessed a Facebook page featuring 96 statuses. Statuses were~     intended to engage cognitive processes, followed by behavioral processes of change per the~     Transtheoretical Model of behavior change. Content posted on the static Facebook page was~     identical to the dynamic page. However, the static group viewed all 96 statuses on the first~     day of the study, while the dynamic group received only 1-2 of these status updates per day~     throughout the intervention. Anxiety was measured using the Overall Anxiety Severity and~     Impairment Scale (OASIS). Time spent engaging in physical activity was assessed using the~     International Physical Activity Questionnaire (IPAQ).~   "
15524|NCT03363724|"~     HaGuide version 1.0 (Neuro-Omega Ltd.) is a software module add-on to the FDA cleared~     Neuro-Omega System (K123796). It was designed to facilitate the use of Neuro-Omega's system~     by automatically mapping visually the depth of STN landmarks intra-operatively. HaGuide~     algorithm computes and displays the STN entry and exit, as well as introduces a detection of~     a distinct DLOR-VMNR boundary. HaGuide visual display is added to the UI and it is~     supplementing and not replacing the previously cleared standard display (visual and audio) of~     the system.~   "
15525|NCT03363711|"~     The proposed project will leverage two programs of research at UPenn and CHOP that are~     delivering technology-based interventions to adolescent and young adult (AYA) cancer~     survivors.~      In the proposed study, all AYA survivors will receive a care plan via a tool (Smart-ALACC).~     They will then be randomized to receive (or not) a mobile health application (AYA STEPS) that~     will provide tailored messages to enhance uptake of their care plan.~   "
15526|NCT03363698|"~     The aim of the study is to assess the prevalence of bronchial hyperresponsiveness (BHR) in~     non-smoking adults with chronic cough and the prevalence of BHR in patients with upper airway~     cough syndrome (UACS) and gastroesophageal reflux disease (GERD), to evaluate the~     relationship between BHR and cough reflex sensitivity, to assess the diagnostic accuracy of~     methacholine challenge test (MCT) in cough variant asthma (CVA) with special regard to its~     discriminating cut off value between CVA and other causes of chronic cough, particularly~     GERD, to estimate prognostic value of BHR, fractional exhaled nitric oxide (FeNO) and induced~     sputum eosinophil count in predicting response to asthma treatment.~      Patients diagnosed with a chronic cough will undergo the standard diagnostic work-up~     recommended by experts for patients with a chronic cough, including methacholine challenge~     test (MCT) and an at least 4-week period of causal treatment. Patients with BHR in MCT will~     be treated with - in first step B2-agonist and inhaled corticosteroid (ICS) for at least 4~     weeks, if improvement is not significant in next steps with leukotriene receptor antagonist~     (LTRA) or systemic corticosteroid. A good treatment response, evaluated by visual analogue~     scale (VAS), Leicester Cough Questionnaire (LCQ) and cough challenge will confirm the~     diagnosis of the disease. A statistical analysis will consist of the frequency of BHR in a~     chronic cough, correlation between the results of MCT and cough reflex sensitivity in~     capsaicin inhalation test and cut-off point for MCT to discriminate asthma from other causes~     of a chronic cough.~   "
15527|NCT03363685|"~     The purpose of this study is to learn whether our own made predictive algorithm can be used~     as a clinical practical decision support for patients with NSCLC spinal metastasis. The~     scoring system consists of the use of EGFR-TKI, KPS, Age, SCC, CA125 and smoking history. By~     predicting survival doctors could determine which patients are suitable for palliative~     therapy.~   "
15540|NCT03363516|"~     Insulin resistance (IR), beyond its well-defined role in the appearance and progression of~     diabetes mellitus (DM), is the recognized pathogenetic factor underlying vascular aging.~     Recently, the existence of a cerebral IR, responsible of the appearance and progression of~     many forms of dementia and mild cognitive impairment (MCI), has been hypothesized. On the~     other hand, it is well known that DM acts as a cardiovascular (CV) risk factor per se. In the~     last years it has been demonstrated that also glucose normotolerant subjects who exhibit~     plasma glucose levels >155 mg/dL 1h-post load, have a CV risk similar to that of diabetic~     patients. Thus, these category of subjects is characterized by IR and, being MCI the~     expression of IR in the brain, the principal hypothesis of our study is that these subjects~     may also develop neuropsychological alterations, earlier with respect of the general~     population.~   "
15528|NCT03363672|"~     Chronic postoperative pain (CPP) remains a disturbing and obscure clinical problem, which~     could last for more than 3 months after surgery. The aim of present study was to assess the~     prevalence of CPP, investigate its impact on life quality and explore its potential risk~     factors. After informed consent was signed, patients receiving surgery under general~     anesthesia in Peking Union Medical College Hospital and other medical centers participating~     in this study during 2018 will be included. Patients' preoperative information will be~     collected from medical record, including basic demographic data, primary disease and previous~     chronic diseases. Intraoperative information will be obtained from anesthesia record,~     including surgical scope, duration, length and location of incisions and blood loss. Acute~     pain will be evaluated in the ward of the department of surgery, when an app will be~     installed on patients' mobile phones. Our long-term postoperative follow-up would be~     performed by sending out survey questionnaires via this app in the 4th, 8th, 16th, 32th, and~     48th weeks after surgery. The survey covers questions regarding the intensity,~     characteristic, location and impact on daily activities of CPP. Information regarding~     treatment of CPP will also be collected, if any. All the data gained will be summarized in~     our database and analyzed.~   "
15529|NCT03363659|"~     One of Disulfiram antitumor effects suggested in preclinical studies is MGMT~     (methyl-guanine-methyl-transferase) inhibition. Disulfiram MGMT inhibitory effect is enhanced~     by addition of Copper. This study evaluates the impact of DSF + Cu combination when added to~     standard Temozolomide in the treatment of unmethylated GBM patients.~   "
15530|NCT03363646|"~     Despite major advances, infections remain one of the major causes of morbidity and mortality~     in patients undergoing orthotopic liver transplantation (OLT). Furthermore, data on the~     epidemiology, severity, and type of post-OLT infections nowadays available come from dated,~     monocentric, retrospective series. Finally, there is no available data focused on the~     critical OLT patient admitted to the Intensive Care Unit (ICU). Therefore this study was~     conceived (1) to describe incidence, severity, epidemiology and outcomes of infections~     recorded in OLT patients in the ICU (first or re-admission ); (2) to identify possible risk~     factors and (3) to report the type of the involved microorganism with their antibiotic~     sensitivity pattern~   "
15531|NCT03363633|"~     The primary objective of this study is to compare two treatment strategies for symptomatic~     venous stasis disease with and without venous ulcer. These treatments are compression therapy~     alone vs. sclerotherapy of refluxing perforating veins with compression.~   "
15532|NCT03363620|"~     The purpose of this randomized controlled clinical trial was to compare the transverse~     development of the arches and the incisor inclination comparing two different ligating~     systems (SL vs CL) with the same arch form protocol (Damon arch form) and the same~     disarticulation protocols after the alignment and leveling period of non-extraction patients.~   "
15533|NCT03363607|"~     The study evaluates the accuracy of indirect bonding using 3D printed transfer tray versus~     thermoformed transfer tray. Half of the brackets will be bonded indirectly using the 3D~     printed transfer tray and the other half will be bonded indirectly using the thermoformed~     transfer tray.~   "
15534|NCT03363594|"~     This study is a non-interventional, multicentre observational study to be conducted at 1000~     sites in India. The study targets to enrol approx. 50000 patients with approx. 50 patients~     per site. The study would enrol Diabetes Mellitus patients who provides written informed~     consent. No study medication will be prescribed or administered as a part of study procedure.~     Patients, who have been treated as per Investigators' routine clinical practice will be~     screened for enrolment in study. The study will be initiated after obtaining written approval~     of Independent Ethics Committee (IEC) /Institutional Review Board (IRB).~   "
15535|NCT03363581|"~     Roux-en-Y gastric bypass (RYGB) decreases appetite, caloric intake, glycemia, and body~     weight, all of which are maintained long term.It is controversial whether, after RYGB,~     patients choose to eat less high fat and sugary foods in favor of lower energy dense~     alternatives. Therefore the proposition to use direct measures in humans after RYGB to test~     the hypothesis that the selection and intake of foods varying in fat content and glycemic~     index, as well as the pattern of ingestion within and across meals, changes in a manner that~     leads to beneficial outcomes on body weight.~   "
15536|NCT03363568|"~     This study evaluates the impact of computerized inhibitory control training on~     attention-deficit hyperactivity disorder (ADHD) symptoms and ADHD-linked neural signatures in~     children with ADHD. Children were randomly assigned to adaptive computerized training (n=20)~     or non-adaptive computerized training control (n=20) with identical stimuli and goals.~   "
15537|NCT03363555|"~     This is an open-label, multi-center, nonrandomized, Phase 2 study to evaluate efficacy and~     safety of SHR-1210 in subjects with relapsed or refractory extranodal NK/T cell~     lymphoma.Efficacy will be assessed every 8 weeks according to 2014 Lugano criteria.Safety~     evaluations (both clinical and laboratory) are performed at baseline, before each study~     treatment, and throughout the study.~   "
15538|NCT03363542|"~     The investigators propose to undertake a controlled dietary intervention study in UAE~     subjects with visceral obesity to examine the feasibility of a diet rich in fruits,~     vegetables and/or whole-grain fiber in the UAE population. The research will also investigate~     the longer-term influence of increased fruits, vegetables and fiber consumption on health and~     its capacity to sustain lifestyle change.~   "
15539|NCT03363529|"~     Depression is a major health challenge, and despite developments in pharmacotherapy and~     psychotherapy a substantial part of patients will only recover very slowly and incompletely,~     and 10-25 % of the patients are resistant to treatment. Therefore, new treatment initiatives~     are in demand. Chronotherapeutics can regulate diurnal rhythms and sleep, and have shown~     promising results on antidepressant effects. Among chronotherapeutic treatment modalities,~     Bright Light Therapy (BLT) has been used in treatment of depression and sleep disorders for~     several decades with both an antidepressant and a sleep improving effect. BLT has also been~     shown to augment antidepressant therapy.~      Objectives. The objective of this trial is to investigate the feasibility of a combination of~     LED-light armatures aiming to mimic sunlight, when installed in the patient rooms of a~     psychiatric inpatient Ward. Investigators has opted for using a randomized design that will~     subsequently be tested in a larger clinical trial with depression severity as the primary~     outcome. In this feasibility study investigators will register the stability of the system,~     the influence of the light on patients regarding tolerability, comfort, depression level, and~     sleep. Investigators also so want to measure and collect specific light-data on the~     Non-image-forming light (NIF) by using specially designed light sensors to capture the~     spectral distribution of the light. Finally investigators will test the electronic case~     report form (eCRF) that has been designed for the trial.~      Design. The design is a randomised controlled feasibility trial with two arms: an active~     dynamic light trial arm and a standard light trial arm with blinding of depression outcome~     assessors (Hamilton depression rating scale), data collection, and data analyses.~     Randomization will be with a rate for active and standard of 2 to 1.~   "
15541|NCT03363503|"~     The aim of the current study is to compare the efficacy and safety of Salmeterol/Fluticasone~     50/500 mcg Inhalation Powder treatment administered via Capsair twice daily and original~     product Seretide Diskus 500 mcg Inhalation Powder treatment twice daily in patients with~     moderate-severe COPD.~      Spirometric measurements will be performed at 12 different time points at pre-treatment and~     post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and~     12.hr) during the treatment visits of 11-weeks study period.~   "
15542|NCT03363490|"~     Osteoarthritis is the most common chronic disabling disease,the importance of patient's~     self-management in chronic disease has been paid more and more attention internationally.~     Currently, the self-management of OA patients in China is lack of instructions from~     professional clinicians, and leads to inappropriate excise, irregular drug medication. OAKP~     (Osteoarthritis of the Knee Self-Management Program) is a program initiated from University~     of Southern Denmark, follows clinical guidelines of OA, formatted for easy use by patients~     and clinicians, including customized neuromuscular exercise therapy, educational sessions of~     what is OA and how to control body weight to protect the knee.~      The main purpose of this study is to verify the effectiveness of neuromuscular exercise~     therapy and OAKP, see whether it can help patients to relief the symptom and improve life~     quality.~   "
15543|NCT03363477|"~     To demonstrate the pharmacodynamic (PD) equivalence of enoxaparin Rovi (100 mg/mL) 100-mg SC~     injection to Clexane® (100 mg/mL) 100-mg SC injection in healthy volunteers.~      As secondary objective, to evaluate the safety and tolerability of enoxaparin Rovi (100~     mg/mL) in healthy volunteers.~   "
15544|NCT03363464|"~     Empagliflozin, a sodium glucose co-transporter 2 (SGLT-2) inhibitor, was launched as a~     treatment for type 2 diabetes mellitus (T2DM) in the U.S. in August 2014. In contrast with~     several previous cardiovascular outcomes trials, which failed to demonstrate an association~     with a higher or a lower risk of cardiovascular outcomes associated with members of other~     recently marketed antidiabetic classes, the EMPA-REG OUTCOME trial has shown that patients at~     high cardiovascular risk randomized to empagliflozin vs. placebo, were associated with a~     reduced risk of hospitalization for heart failure, cardiovascular mortality, and all-cause~     mortality.However, these and other findings arising from an extensive clinical trial program~     aimed at evaluating the efficacy and safety profile for empagliflozin have yet to be~     demonstrated in a non-trial environment. This study aims to investigate the transferability~     of the effects demonstrated in dedicated randomized clinical studies to a broader population~     under real world conditions.~   "
15545|NCT03363451|"~     The term of End Stage of Liver Disease (ESLD) was raised in 80's of 20 Century, but without a~     restrict definition. Infections are the cause and effect in occurrence and development of~     ESLD, which not only induce or exacerbate ESLD, but also are the most combined complication.~     Multi-resistant bacteria, multi-organ injury, selection of anti-microbes, supporting~     treatment, disorder of intestine microbiota, et al are dilemma in clinical practice.~     Appropriate and formal diagnosis and treatment of ESLD combined infection are imperious~     nowadays.~   "
15546|NCT03363438|"~     The aim of the study was to determine the knowledge attitudes, behaviours and practices of~     sex workers regarding HIV in Martinique, guadeloupe and Saint martin.~   "
15547|NCT03363425|"~     Postoperative pain continues to be inadequately managed and is the most common reason for the~     delay in discharge and unplanned hospital admission after surgery. Opioids remain the~     mainstay for postoperative analgesia. However, there is a continuous search for adjuvant~     therapies to reduce the doses of opioids and their related adverse effects, and extend the~     use of non-opioid analgesia for acute pain after abdominal surgery, thereby improving patient~     recovery. Currently there are no clinical trials that investigate the effect of intravenous~     lidocaine vs dexmedetomidine on postoperative pain, analgesic consumption and bowel function~     of patients undergoing abdominal gynaecological surgery. Purpose of this prospective double~     blind randomised clinical trial is the investigation of the effect of perioperative~     intravenous infusion of lidocaine vs dexmedetomidine vs placebo (Normal Saline 0,9%) on~     analgesic parameters and functional recovery of patients undergoing abdominal gynaecological~     surgery.~   "
15548|NCT03363412|"~     The transjugular intrahepatic portosystemic shunt (TIPS) is a well-established procedure for~     the treatment of portal hypertensive bleeding, refractory ascites and vascular diseases of~     the liver. The major drawbacks of this procedure are shunt dysfunction and portosystemic~     encephalopathy (PSE). The availability of self-expandable polytetrafluoroethylene-covered~     stentgrafts (PTFE-SGs) has dramatically improved the long-term patency of TIPS. However, the~     incidence of PSE remains a threatening complication in about 50% of patients.~      The Investigators hypothesized that under-dilated PTFE-SGs would not self-expand to nominal~     diameter and their under-dilation would be safe and could reduce the rate of post-TIPS~     encephalopathy, while maintaining clinical efficacy.~      Aim of this proof-of-concept exploratory study is to determine whether under-dilated TIPS~     is a feasible procedure that reduces the incidence of PSE while maintaining clinical~     efficacy.~   "
15549|NCT03363399|"~     Myelodysplastic syndromes (MDS) constitute a heterogeneous group of clonal bone marrow~     neoplasms that predominate in the elderly, with a median age at diagnosis of 70 years. MDS~     are characterized by peripheral blood cytopenia and morphologic dysplasia for one or more~     hematopoietic cell lineage, reflecting ineffective hematopoiesis.~      The diagnostic work-up of MDS includes a bone marrow aspirate and biopsy, which is an~     invasive procedure, for cytomorphologic and cytogenetic evaluations. Because the prevalence~     of disease is lower than 20% in subjects referred for suspected MDS, many patients are~     exposed to unnecessary bone marrow aspiration-related discomfort and harms.~      An objective assay is highly desirable for accurately ruling out MDS based on peripheral~     blood samples, which may obviate the need for invasive bone marrow aspiration and biopsy in~     patients with negative results.~      Few studies have investigated the value of peripheral blood flow cytometric analysis for the~     diagnosis of MDS and/or chronic myelomonocytic leukemia (CMML). Although promising, these~     studies lacked replication of their results, used a case-control design, which was prone to~     spectrum bias, or yielded imprecise diagnostic accuracy estimates due to relatively limited~     sample sizes.~      Anecdotal evidence supports the potential of flow cytometric analysis of peripheral blood~     neutrophil myeloperoxidase expression for the diagnosis of MDS and CMML. Myeloperoxidase is~     an enzyme synthetized during myeloid differentiation that constitutes the major component of~     neutrophil azurophilic granules. Myeloperoxidase expression may reflect neutrophil~     hypogranulation, which is a classical although subjective dysplastic feature of MDS. Flow~     cytometric analysis of myeloperoxidase expression in bone marrow neutrophil granulocytes has~     been used for discriminating low versus high grade MDS. Yet a study reporting on the accuracy~     of flow cytometric analysis of peripheral blood neutrophil myeloperoxidase expression for the~     diagnosis of MDS is still lacking, to our knowledge.~      In this study, the investigators hypothesize that flow cytometric analysis of neutrophil~     myeloperoxidase expression in peripheral blood may accurately rule out MDS and obviate the~     need for bone marrow aspiration and biopsy, with sensitivity approaching 100%, in routine~     practice.~      In this observational diagnostic accuracy study, burden will be null for recruited patients.~     No specific intervention is assigned to participants. All diagnostic testing, procedures, and~     medication ordering are performed at the discretion of attending physicians. Flow cytometry~     analysis of peripheral blood neutrophil myeloperoxidase expression will not require~     additional blood sample. A test result will have no impact on patient management. No~     follow-up visits are planned in this cross-sectional study.~   "
15550|NCT03363386|"~     The aim of the study is to investigate proprioceptive exercises training combined with~     aerobic exercises and resistive exercises training combined with aerobic exercises on dynamic~     balance and superficial sense. The patients were randomly divided into Proprioceptive~     Exercise Training Group (PG) (n=15) and Resistive Exercise Training Group (RG) (n=15). All~     subjects were included exercise education program and both groups had trained aerobic~     exercise program for walking on treadmill (2times/wk. 6 week duration).~   "
15551|NCT03363373|"~     Children and adults diagnosed with high risk neuroblastoma and refractory osteomedullary~     disease will be treated for up to 93 weeks with naxitamab and granulocyte-macrophage colony~     stimulating factor (GM-CSF). Participants will be followed for up to five years after first~     dose.~      Naxitamab, also known as hu3F8 is a humanised monoclonal antibody targeting GD2~   "
15552|NCT03363360|"~     The study is a multicenter, sub-center contrast, cross-sectional survey.The primary objective~     of this study was to assess the Comprehensive Awareness and Control of blood glucose, blood~     pressure, and blood lipids among patients with type 2 diabetes in China Jiangxi. An~     additional objective was to investigate the impact of hospital type on clinical outcomes.~   "
15553|NCT03363347|"~     Papillary thyroid cancer (PTC) is the most common neoplasia in the thyroid gland. The~     combination of surgery, followed by radioiodine therapy (RIT) and thyroid-stimulating hormone~     (TSH) suppressive therapy is usually a curative option for differentiated thyroid cancer~     (DTC). Although DTC has a good prognosis generally, it is problematic when dedifferentiation~     is suspected and radioiodine refractoriness presumed. One possible therapy option for~     redifferentiation is the pretreatment with retinoids. From 2008 to 2014 there were 13~     patients with PTC who were treated with retinoids after thyroidectomy before a further course~     of radioiodine. A recent study has shown that the efficacy of Selumetinib, another option for~     redifferentiation depends on the mutational status of the treated patient. In this~     retrospective study the investigators looked for a similar association between BRAF V600E and~     redifferentiation therapy with retinoids. As retinoids have fewer side effects compared to~     TKI, it is worth performing studies to assess the importance of genetic marker for the~     response and to estimate the chances of this specific patient collective. BRAF V600E seems to~     be associated with better long-term response after redifferentiation therapy with 13-cis RA~     in RAI-R PTC. Therefore, evaluation of BRAF mutational status prior to redifferentiation~     therapy could be beneficial for predicting response.~   "
15554|NCT03363334|"~     C-935788-055 is an open-label, multi-center, expanded access (EAP) study.~   "
15555|NCT03363321|"~     This study is designed to evaluate the safety, tolerability and efficacy of long-term~     treatment with PF-06741086 in subjects with severe hemophilia who participated in the 3-month~     Phase 1b/2 B7841002 study. Additionally, de novo subjects will be recruited into this study.~   "
15556|NCT03363308|"~     The aim of the study is to evaluate a health workforce capacity building and quality~     improvement intervention focused on integrated day-of-birth and post-pregnancy care at 16~     hospitals in Kinshasa, Democratic Republic of Congo. The intervention package consists of a~     low-dose, high-frequency (LDHF) training of health workers, support for quality improvement~     teams, and provision of critical equipment, supplies and drugs within a quality improvement~     (QI) framework.~   "
15557|NCT03363295|"~     The objective of this study is to evaluate the macular and choroidal thickness of patients~     submitted to intracameral moxifloxacin during the phacoemulsification surgery for~     endophthalmitis prophylaxis.~      The investigators propose a randomized clinical trial double-blind. The patients will be~     divided into two groups: one will receive intracameral moxifloxacin injection during~     phacoemulsification surgery and the other won't.~      Both Spectral Domain - Optical Coherence Tomography (SD-OCT) and Enhanced Depth Imaging -~     Optical Coherence Tomography (EDI-OCT) will be performed for each patient pre-operatively and~     on the 30th and 60th postoperative days.~      After collecting, the data will be compared to evaluate if there was any difference in the~     macular thickness and choroidal thickness between the two groups.~   "
15558|NCT03363282|"~     To study the efficacy and safety of amniotic membrane transplantation as an adjunctive~     therapy after surgical excision of primary pterygium and compare the clinical outcomes with~     conjunctival autograft~   "
15559|NCT03363269|"~     The objective of this study is to evaluate the safety and efficacy of ID1201 in patients with~     mild Alzheimer's disease~   "
15560|NCT03363256|"~     The purpose of the current study is to evaluate the preliminary efficacy of the Therapeutic~     Education System-Native Version (TES-NAV) (an efficacious web-delivered psychosocial~     intervention for substance use disorders adapted with American Indians/Alaska Natives~     [AI/AN]) to determine whether a future large-scale effectiveness trial is warranted.~     Specifically, a randomized controlled trial among urban AI/AN (N=80) attending outpatient~     addiction treatment services will be conducted to (1) estimate preliminary effect size of 12~     weeks of TES-NAV on substance use disorder outcomes; (2) explore relevant moderators of~     TES-NAV outcomes; and (3) assess cultural factors that may correspond to variation in~     outcome.~   "
15561|NCT03363243|"~     The public health relevance of this proposed project is substantial given the current opioid~     abuse epidemic as identified by the Centers for Disease Control (CDC). This study finalizes~     and tests a new psychotherapy treatment that is designed to treat chronic pain and opioid~     addiction at the same time in a format that could be easily used in a community addiction~     treatment setting. Final products of the study will yield an integrated STOP~     (Self-regulation/Cognitive-behavioral therapy (CBT) Therapy for Opioid addiction and Pain)~     manual guided protocol, patient workbook, and therapist training protocol.~   "
15562|NCT03363230|"~     Mindfulness training has proven to be a reliable treatment for patients with Borderline~     Personality Disorder (BPD).The present randomized-controlled study examines the effects of~     mindfulness training on emotion regulation and impulsitivy. In addition, fMRI data was~     collected pre and post intervention. 70 patients with BPD diagnosis were randomized to either~     mindfulness or interpersonal effectiveness skills training. Assessments were conucted~     pre-and-post-intervention.~   "
15623|NCT03362424|"~     Randomized clinical study involving 44 patients, evaluating the effect of mesenchymal cells~     on rotator cuff repair. The primary outcome will be post-operative MRI tendon integrity and~     secondary outcomes clinical assessment by the UCLA and American Shoulder and Elbow Surgeons~     (ASES) scales and pain by visual analog scale (VAS).~   "
15563|NCT03363217|"~     This is a phase 1/2, open-label, interventional clinical trial that will study the response~     rate of pediatric glioma and plexiform neurofibroma (PN) to oral administration of~     trametinib. Patients meeting all inclusion criteria for a given study group will receive the~     study medication at a daily dose of 0.025 mg/kg up to a total of 18 cycles, in 28-day cycles.~     A total of 150 patients will be recruited as part of this clinical study.~      Patients aged between 1 month (corrected age) and 25 years old will be eligible, in order to~     include a maximum of patients affected by low-grade glioma (LGG) and PN. This study includes~     four groups: patients with neurofibromatosis type 1 (NF1) and LGG, NF1 patients with PN,~     patients with LGG with a B-Raf Serine/Threonine-protein Kinase/Proto-oncogene Encoding B-Raf~     (BRAF) fusion and patients with glioma of any grade with activation of the Mitogen-activated~     Protein Kinase/Extracellular Signal-regulated Kinases (MAPK/ERK) pathway. All patients except~     patients with PN must have failed at least one line of treatment.~      The study will also explore the molecular mechanisms behind tumor development, progression~     and resistance to treatment. Furthermore, this study will also explore important aspects for~     patients with brain tumors by including assessment of quality of life and neuropsychological~     evaluation.~   "
15564|NCT03363204|"~     There is no accurate diagnosis method for bruxism for now. Consequences of bruxism over~     teeth, muscles and articulation of the jaw are important.~      This study aims to develop a innovative tool in order to accurately rapidly diagnose bruxism~     in ambulatory evaluation.~   "
15565|NCT03363191|"~     The objective of this study is to evaluate fluticasone furoate/vilanterol compared with~     fluticasone furoate alone in subjects with asthma that is uncontrolled on low to mid dose~     inhaled corticosteroid (ICS) or low dose ICS/ long acting beta agonist (LABA) combination.~     This is a phase IV, randomized, double-blind, parallel group, multicenter study evaluating~     fluticasone furoate/vilanterol 100/25 micrograms (mcg) and fluticasone furoate 100 mcg once~     daily, delivered as an inhalation powder using the ELLIPTA® device in subjects with~     uncontrolled asthma despite daily ICS or ICS/LABA therapy. The study will measure treatment~     response and asthma control using the Asthma Control Questionnaire-7 (ACQ-7) focusing on~     symptomatic control. In this study, proportion of subjects with an improvement in ACQ-7 score~     of >=0.5 at Week 12 compared to Baseline for the fluticasone furoate/vilanterol 100 mcg/25~     mcg and fluticasone furoate100 mcg groups will be assessed. The total study duration for each~     subject will be 17 weeks including 4-week run in period, 12-week treatment period and 1-week~     follow up period. Approximately 1012 subjects will be randomized into the study. ELLIPTA is a~     registered trademark of GlaxoSmithKline group of companies.~   "
15566|NCT03363178|"~     Healthy adults will be once administered GC3107(BCG Vaccine) Intradermally.~   "
15567|NCT03363165|"~     HI-PAD is a placebo controlled double-blind randomized pilot clinical trial to determine~     whether VM202 may improve walking ability in people with lower extremity peripheral artery~     disease (PAD).~   "
15568|NCT03363152|"~     Laparoscopic surgical suboptimal outcomes in patient safety measures are correlated with (i)~     cognitive load / level of attention of the operating surgeon, (ii) the frequency and degree~     of disruptions to the surgical workflow, and (iii) the misalignment of visual and motor axes~     in laparoscopic equipment / setting (eye-hand coordination).~   "
15569|NCT03363139|"~     Three laboratories will participate in the study. Each laboratory will analyze the same~     samples by different methodologies according to the flow indicated in figure 1. This design~     will allow comparing the agreement performance of different methods available for T790M~     identification in circulating-free DNA isolated from peripheral blood.~   "
15570|NCT03363126|"~     Endoscopic endonasal transsphenoidal surgery is a procedure for the treatment of pituitary~     macroadenomas that cause visual impairment through optic chiasm compression. The aim of this~     retrospective study is to describe visual outcome after this procedure.~   "
15571|NCT03363113|"~     Symptoms of oromandibular dystonia can be alleviated by injections of botulinum toxin. The~     scope of this study is to describe the efficacy of this procedure, by a retrospective~     systematic review of patients medical charts~   "
15572|NCT03363100|"~     The Diabetes Coaching Program for Medicare Advantage Members with Type 2 Diabetes - Impact on~     A1c trial is a 26-week long, prospective, intent-to-treat, 2-arm randomized controlled trial~     that aims to evaluate the impact of the Digital Health Partnership on A1c levels for~     individuals with uncontrolled Type 2 diabetes.~   "
15573|NCT03363087|"~     There is increasing evidence that having AF is associated with some scarring of the upper~     chamber of the heart, the left atrium. There is also evidence that the amount of scarring can~     predict ablation success rates. Recently, rapid ultra high density mapping equipment has~     become available and this has the capability of defining the electrical scar in the atrium in~     detail. The equipment used to do this is standard approved equipment for the procedure but~     its use for making scar maps has not been fully assessed.~      In the mapping phase of the study therefore, the aim will be to collect high density scar~     maps in AF and normal rhythm to see how they compare. Maps will be collected in different~     ways to see if that changes their accuracy. The study will also assess if the values~     previously suggested as representing scar with lower density mapping systems are still~     appropriate where high density mapping equipment is used. The results from this study will~     help to improve the understanding of scar in the atrium and help demonstrate the most~     efficient way to collect scar information using this high density mapping equipment. In the~     future, clinicians may be able to use these very detailed scar maps to tailor and refine the~     way they ablate patients with AF, though the focus of the current study is just on collecting~     the scar information.~      While identifying areas requiring ablation is important to an ablation procedure, the other~     important aspect is the efficacy of ablation. Until now, we have been reliant on assessing~     our inputs into an ablation (such as the level of contact and the power delivered) but have~     been limited in the assessment of the output of an ablation in terms of lesion~     characteristics. New ablation catheter technology is now available which can assess the~     localised impedance drop with ablation. This is likely a better surrogate for lesion~     parameters than what we have previously had available and merits further study. Based on such~     study, we may be able to define targets for ablation which would help to guide future~     ablations.~   "
15574|NCT03363074|"~     The purpose of this study is to compare low-level laser therapy and insole interventions on~     pain, function and muscle strength in subjects with posterior tendon insufficiency.~   "
15575|NCT03363061|"~     The use of antithrombotics (antiplatelet agents and anticoagulants) is increasing with an~     aging global population.Management of antithrombotics in patients undergoing invasive~     procedures including gastrointestinal endoscopy remains a challenge. Management approach~     includes taking a precarious balance between the risk of thromboembolism after interruption~     of antithrombotics and risk of bleeding with the continuation of antithrombotics. Colonoscopy~     remains one of the commonest endoscopic procedures performed. The optimal management strategy~     of different antithrombotics during colonoscopy remains unclear.~   "
15576|NCT03363048|"~     An experimental trial will be conducted whereby a Supplemental Nutrition Assistance Program~     (SNAP)-like food benefit program will be implemented in 240 SNAP eligible households.~     Baseline and follow up measures will include three 24-hour dietary recalls; household food~     purchase receipt collection; and household food security questions. The individual level~     measures will be collected from the adult most responsible for food shopping and a child in~     the household. After baseline measures are completed households will be randomized to one of~     three conditions: 1) restriction (not allowed to buy sugar sweetened beverages, sweet baked~     goods, or candies with food benefits); 2) restriction paired with an incentive (30% financial~     incentive on fruits and vegetables and restriction of purchase of sugar sweetened beverages,~     sweet baked goods, or candy with food benefits); or 3) control (no incentive or~     restrictions). Households in all conditions will be given a debit card that will have funds~     added monthly for a five month period. The dollar amount placed on the card monthly will be~     similar to the amount the household would receive if enrolled in SNAP. All participants will~     be instructed to use the debit card for food purchases only, and they'll be told they~     shouldn't use the card to purchase items currently non-eligible for purchase with SNAP~     benefits (e.g. alcohol, food from restaurants). Those in the restriction condition will also~     be told they cannot use the card to buy sugar sweetened beverages, sweet baked goods, or~     candies. They may purchase these foods using their own money, but not the debit card. Those~     in the restriction plus incentive condition will receive the instructions provided to the~     restriction group plus they will be told that they'll receive a 30% bonus for fruits and~     vegetables purchased using their debit card. Analyses will determine whether the nutritional~     quality of the diet at follow-up differs between experimental groups.~   "
15577|NCT03363035|"~     H-REPLACE trial is a prospective, randomized, open-label, active-controlled, multicenter~     study in participants with ACS (STEMI or NSTEMI, unstable angina). All eligible participants~     receiving background treatment of aspirin plus clopidogrel or ticagrelor will be randomly~     assigned to either oral rivaroxaban 2.5 mg twice daily or rivaroxaban 5 mg twice daily or~     subcutaneous (SC) enoxaparin 1mg/kg twice daily until hospital discharge or 12 hours before~     revascularization therapy for a maximum of 8 days.~   "
15578|NCT03363022|"~     All patients of Acute liver failure not meeting the KCH (King's College Hospital) criteria/or~     meeting KCH criteria not having option of liver transplant will be recruited for the trial.~     The first group will receive Standard medical care with Fecal Microbiota transplant on Day 1~     for 3 consecutive days. FMT (Fecal Microbiota Transplant) will be delivered rectally which~     will be placed bedside. Suitable donor will be screened and the stool samples will be used as~     per criteria. Stool samples will be taken at the time at Day 0, 1(Post FMT), Day 4, 6, 14,21.~     Sepsis screen will be sent. Inflammatory markers will be sent on Day 0,1, 4,6, 14,21. The~     second group will receive standard medical therapy/and an placebo. Stool samples will be sent~     on Day 0,1, 4, 6 , 14,21. Inflammatory markers will be sent on the time on day 0,1 4,6 ,~     14,21.~   "
15579|NCT03363009|"~     Poor physical performance and poor nutritional status increase the risk of complications~     after major surgery. Prehabilitation is the process of enhancing the functional capacity~     before surgery.~      A major problem is the adherence of the patients to the physical program. A controlled~     randomized study is therefore proposed to determine the impact of coaching on functional~     exercise capacity. All patients will wear connected devices to measure their physical~     activity. They will be randomized to either a group in which coaching will be adapted to the~     physical activity, or a control group in which coaching is performed without any information~     about physical activity~   "
15580|NCT03362996|"~     There is accumulating evidence suggesting that olive oil may have a positive impact on~     conditions involving cognitive deficits, such as MCI and AD. More specifically, these~     beneficial effects are mostly attributed to some phenolic compounds in olive oil, such as~     oleocanthal, oleuropein and ligstroside. Oleocanthal is deeper studied than the rest of olive~     oil phenol components and it shows promising results in neuroprotection against AD through~     various suggested mechanisms, such as the enhancement of amyloid-beta clearance in the brain~     and the inhibition of neurofibrillary tangles formation. For this reason, it would be~     interesting to study the effects of freshly-pressed extra virgin olive oil, as it is known~     that it contains oleocanthal in higher concentrations than the normal extra virgin olive oil.~     The aim of the study is to evaluate the beneficial effect of extra virgin olive oil in~     comparison to freshly-pressed extra virgin olive oil on patients diagnosed with mild~     cognitive impairment (MCI).~      Study Type: Interventional Study Design: Allocation: Randomized Intervention Model: Parallel~     Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention~   "
15581|NCT03362983|"~     Patient with complex comorbidities present a growing challenge for health-care providers,~     that the current system is poorly designed to handle. Concomitant cardiovascular disease,~     renal dysfunction and diabetes represent almost half of all patients attending cardiac,~     kidney and diabetes clinics. Patients with all three of these will be randomized to standard~     care or to a combined, integrated, person-centered, intensified chronic disease management.~   "
15582|NCT03362970|"~     Children presenting for emergency department (ED) care with bloody diarrhea (i.e.~     hematochezia) represent a diagnostic challenge. Infectious enteric pathogens - Salmonella,~     Shigella and Shiga toxin-producing Escherichia coli (STEC) - are at the top of the~     differential diagnosis list. STEC is of greatest concern because ~15% of infected children~     develop the Hemolytic Uremic Syndrome (HUS). Our team has demonstrated that antibiotic~     administration to STEC-infected children increases the risk of developing HUS while~     dehydration is associated with mortality. Rapidly identifying children with STEC infection~     can reduce unnecessary resource use in uninfected children while providing them to those with~     confirmed STEC infection. The study team will conduct a prospective ED-based study that will~     randomly allocate 60 children to either standard care as dictated by the treating physician~     or to the use of a 22-pathogen, nucleic acid based, 1-hour run time diagnostic test. The~     study team will evaluate the impact of testing on clinical resource use, clinical outcomes,~     costs and patient satisfaction.~   "
15583|NCT03362957|"~     Purpose: To evaluate embolization as a treatment for OA related knee pain versus placebo to~     demonstrate the actual effect of embolization on pain and disability.~      Participants: There will be 21 subjects enrolled over the age 40 with knee pain secondary to~     arthritis.~      Procedures (methods): This will be a single-blinded randomized-controlled study of GAE versus~     placebo in a small population with knee pain secondary to arthritis to determine safety and~     efficacy. Clinical procedures and evaluations will consist of a preoperative screening~     assessment to determine if the potential study subject meets the inclusion and exclusion~     criteria, enrollment, surgical procedure for geniculate artery embolization, and follow-up~     visits at 24 hours, 2 weeks, 1, 3, 6, & 12 months. An MRI may be performed after the 1-month~     visit.~   "
15975|NCT03357835|"~     It is intended to show that a computer software called Trauma Decision System (TravmaDS) for~     the determination of the urgency of trauma patients who applied to Emergency Medical Clinic~     gives more accurate, more objective, faster results than the triage scored by medical and~     non-medical personnel and to show the fact that TraumaDS provides more patient satisfaction.~   "
15584|NCT03362944|"~     Purpose: In this preparatory study, the investigators will demonstrate the feasibility of~     using a structured MT intervention as a treatment for MDD by measuring stress hormone levels~     and HRV before and after interventions.~      Participants: Participants will be healthy controls ages 18 to 34 years old, both male and~     female, english speakers, with no history or cardiovascular or neurological diseases.~      Procedures: A passive listening control will be used in conjunction with an active music~     therapy intervention to assess whether the physiological correlates can be targeted by active~     music-making. Participants will experience both the control and the intervention in separate~     sessions for a within participants design. HRV and saliva samples will be recorded pre and~     post intervention for both sessions. The investigators anticipate that the active MT~     intervention will produce greater physiological changes (pre intervention to post~     intervention) than the passive listening control. Model-based estimation of treatment effects~     and components of variance will inform our choice of the sample size deemed necessary for a~     subsequent grant-funded MT-MDD clinical trial.~   "
15585|NCT03362931|"~     This study will evaluate the safety and IOP-lowering effectiveness of XEN in patients with~     Angle Closure Glaucoma.~   "
15586|NCT03362918|"~     Polycystic Ovary Syndrome (PCOS) is a common hormonal disorder characterized by~     oligo-ovulatory menstrual dysfunction, androgen excess and polycystic ovaries. It affects ten~     to fifteen percent of reproductive-age women and has been associated with complications in~     reproductive, metabolic and cardiovascular health. Current Clinical Practice Guidelines~     suggest exercise and weight loss for PCOS, although their specific roles in improving~     PCOS-related symptoms are uncertain.~      Non-pharmacological treatments are appealing to many reproductive age women. There is~     preliminary evidence that exercise in PCOS may increase menstrual regularity, ovulation,~     cardiorespiratory fitness, health-related quality of life (HRQOL) and self-esteem, and~     decrease body fat and insulin resistance. These studies have been limited by short durations~     and lack of randomization or appropriate control groups.~      High-intensity interval training (HIIT), which involves brief intervals of near-maximal~     exercise alternating with lower-intensity exercise, is becoming increasingly popular in the~     exercise community. In some non-PCOS trials, HIIT resulted in improved cardiovascular fitness~     and greater fat loss compared with continuous aerobic exercise. No other trials are currently~     on-going that are comparing HIIT with continuous aerobic exercise training in women with PCOS~     (as confirmed by searches of the literature and the clinical trials registry maintained by~     the US NIH).~   "
15587|NCT03362905|"~     Despite being the most common method of contraception, the use of intrauterine devices (IUDs)~     is limited by the associated pain during insertion. Many pharmacologic interventions had been~     studied for their efficacy to reduce IUD insertion pain, of them, lidocaine was found to be~     superior over NSAIDs or other local anesthetics. This work aims at comparing the safety and~     efficacy of different lidocaine formulations to optimize selection in reduction of IUD~     associated pain.~   "
15588|NCT03362879|"~     The purpose of this study is to evaluate treatment of advanced Parkinson's Disease (PD)~     patients on levodopa-carbidopa intestinal gel (LCIG) monotherapy in a routine clinical~     setting.~   "
15589|NCT03362866|"~     Viral hepatitis B, C and Δ represent a global public health problem for which France was very~     early mobilized. Despite this, in its foreword, the Dhumeaux report on Management of people~     infected with hepatitis B or hepatitis C viruses identifies a residual area of weakness in~     this care that is the incomplete regional epidemiological data in the Overseas Territories.~     The specific ethno-socio-cultural characteristics of these territories make it difficult to~     transpose data from the mainland France. This study aims at improving our knowledge on the~     characteristics of patients with hepatitis B, C and Δ in Reunion Island, their follow-up,~     their evolution and complications.~   "
15590|NCT03362853|"~     A randomized, single-center, placebo and positive control, 4-period and 4-crossover clinical~     study with the following main purposes: (1) To evaluate the effect of a single-dose oral~     administration of nemonoxacin malate capsule on QTc intervals and heart rhythms of healthy~     subjects. (2) To evaluate the influence of food intake on QTc intervals and pharmacokinetic~     characteristics.~   "
15591|NCT03362840|"~     The current study evaluates the effectiveness of the Early Start Denver Model (ESDM) when~     integrated in existing community preschools for children with ASD. The study compares~     developmental gains made a group of children receiving preschool-based ESDM compared to a~     group of children receiving eclectic interventions in their preschools (treatment as usual).~   "
15592|NCT03362827|"~     The present study is aimed to assess the LTP-like pain amplification in chronic low back pain~     patients to explore the central and peripheral effect for pain LTP.~   "
15593|NCT03362814|"~     The purpose of this study is to assess the efficacy and safety of Ravidasvir in combination~     with Danoprevir/r and ribavirin(RBV) by sustain virologic response 12 (SVR12), in~     treatment-naive, non-cirrhotic, chronic hepatitis C genotype 1 infected patients.~   "
15594|NCT03362801|"~     Sarcopenia is associated with lower prognosis in solid tumors, but this has not been studied~     in bladder carcinoma requiring cystectomy.~      According to EWGSOP recommendations, the diagnosis of sarcopenia is based on walking speed,~     grip strength and muscle mass. These three elements can easily be measured (specially muscle~     mass measurement by bioimpedencemetry or tomodensitometry).~      This cohort study will collect clinical complementary elements to better understand the~     associated factors present with sarcopenia, in order to prepare an interventional~     preoperative physical reconditioning study.~      The mobility measurement will be carried out by the QAPPA questionnaire (validated in French~     in the elderly) and the quantitative measurement of activity and rest hours during a week by~     a wrist actimeter.~      Standardized geriatric data will also be collected: ADL, IADL for autonomy, MMSE for~     cognitive status, nutritional status (% weight loss, BMI), pain, GDS15 for depression~     screening, updated Charlson Comorbidity Index to identify polypathology and The STOPP tool~     for potentially inappropriate medication.~      Post-operative morbidity mortality at 30 days will be evaluated according to Clavien-Dindo~     classification. Investigators will also evaluate 6 months geriatric complications : falls,~     loss of autonomy and decreased mobility and physical activity, cognitive degradation,~     undernutrition, institutionalization~   "
15976|NCT03357822|"~     The aim of the prospective real-world study is to evaluate whether sequential combination~     therapy with pegylated interferon plus entecavir/tenofovir could induce higher rates of HBsAg~     loss in nucleoside-treated patients with chronic hepatitis B compared to continuous~     nucleoside treatment.~   "
15595|NCT03362788|"~     Approximately 5% to 7% of patients undergoing percutaneous coronary intervention for the~     treatment of coronary artery disease, require chronic oral anticoagulation on top of aspirin~     and a P2Y12 receptor antagonist, mainly due to non-valvular atrial fibrillation. Advent of~     non-vitamin K antagonist oral anticoagulants (NOAC) increased treatment options, while there~     is cumulative evidence that dual combination of NOAC and P2Y12 receptor antagonist attenuates~     bleeding without compromising efficacy. Greek AntiPlatElet Atrial Fibrillation (GRAPE-AF) is~     an observational study of non-valvular atrial fibrillation patients undergoing percutaneous~     coronary intervention, planning to enroll >500 participants during 1 year period in Greece.~     Patients will be followed-up at 1, 6 and 12 months post hospital discharge. Key data to be~     collected pre-discharge include demographics, detailed past medical history, antithrombotic~     and concomitant treatment. Study's primary endpoint is clinically significant bleeding~     defined as Bleeding Academic Research Consortium (BARC) ≥2) at 12 months, between vitamin K~     antagonists (VKAs) and NOACs-treated patients. All clinical events will be adjudicated by an~     independent endpoint committee.This study would provide real world information on current~     antithrombotic treatment patterns and clinical outcome of patients with non-valvular atrial~     fibrillation undergoing percutaneous coronary intervention.~   "
15596|NCT03362775|"~     The hypothesis of this study is that propofol sedation does not affect the detectability of a~     movement intention in the EEG motor cortex signal. EEG signals will be recorded during the~     realization of intentional movements and movement intentions by the healthy volunteers, as~     well as during median nerve stimulation before and during propofol perfusion according to a~     target control infusion. (0 µg/mL; 0.5 µg/mL and 1 µg/mL).~   "
15597|NCT03362762|"~     Type 2 diabetes is a major problem of public health in the French West Indies, with an~     estimated prevalence of 8%, twice more than in France. In Guadeloupe, according to the~     statistical data of hospital morbidity in 2004, 2643 hospital stays were diagnosed with~     diabetes. These cases mainly concerned woman (62%) and the elderly, from 45 to 74 years old~     (67%).~      The main objective of this research is to describe the insulin protocol used in Guadeloupe~     for treated type 2 diabetes patients and their characteristics:~        -  The duration of the type 2 diabetes~        -  Time elapsing between the diagnosis and the treatment by insulin~        -  Where the follow up care took place~        -  Existence of complications~      Secondary objectives were to describe the link between the HbA1c rate and the insulin therapy~     protocol. And also to present the main inconveniences expressed by patients and their degree~     of autonomy.~   "
15598|NCT03362749|"~     Local tumor ablation is among the major anti-tumor modalities worldwide. Given the number of~     changes that have taken place in the field of tumor ablation in the past 10 years, it is our~     intention to ensure that this highly utilized standardization continues to remain relevant as~     it unites all investigators and clinicians practicing interventional oncology by providing a~     common language to describe therapies and outcomes, develop studies, and communicate with~     other medical specialties. In an attempt to attain greater Asian-wide adoption, the~     investigators will initiate the registry system for local tumor ablation in Taiwan, China,~     Korea, Singapore, Hong Kong and Thailand.~   "
15599|NCT03362736|"~     The purpose of this program is to provide early access to ustekinumab where it is~     commercially unavailable for the treatment of participants with moderately to severely active~     Crohn's disease who have failed treatment with conventional Crohn's disease therapy (example,~     immunomodulators or corticosteroids) and Tumor Necrosis Factor alpha (TNF alpha) antagonist~     therapy (e.g., infliximab, adalimumab, certolizumab pegol, or their biosimilars), or who are~     intolerant to, or have a contraindication to these treatments. During the course of this~     early access program (EAP), through the reporting of serious adverse events (SAEs) and~     non-serious adverse drug reactions (ADRs) by participating physicians, information on the~     safety and tolerability of ustekinumab will be captured.~   "
15600|NCT03362723|"~     This multi-center, open-label, pharmacokinetic study will evaluate the bioequivalence (BE) or~     relative bioavailability (rBA) of three new idasanutlin-tablet variants compared to the~     reference tablet formulation following oral administration of a 300 milligrams (mg) dose in~     participants with solid tumors for whom no further treatment options are available. Following~     the four administrations of idasanutlin in the BE/rBA cycle of the study (Cycle 1),~     participants who have no clinically defined progressive disease and who recover from any~     prior treatment toxicity to Grade less than or equal to (</=) 1 may enter the optional~     treatment extension phase. This extension phase will continue for additional 28-day cycles or~     until disease progression or unacceptable toxicity is observed.~   "
15601|NCT03362710|"~     Peripheral artery disease (PAD) affects mainly elderly patients. The ankle brachial index~     (ABI) and ultrasound imaging are the standard diagnostic tools in PAD diagnostic and severity~     estimation. Measurements are generally performed by a vascular physician. However, access to~     medical specialist is becoming increasingly difficult with long waiting times while the aging~     of the population increases, while most of these patients are seen by the general~     practitioner.~      To date, there is a lot of data in the literature on the value of using various ambulatory~     devices in the diagnosis and severity estimation of PAD but studied one by one.~      The investigators propose to compare the measurements made by a series of simple non-invasive~     ambulatory tools with the measurements performed by the vascular specialist. The~     investigators wish to demonstrate that a series of simple and economical tools, available to~     paramedical health professionals can diagnose PAD and evaluate ts severity the reducing the~     direct and indirect associated costs.~   "
15602|NCT03362697|"~     Prevalence of uro-genital infections during pregnancy move between 7% to 12% in developed~     countries, meanwhile in developing countries this figure moved between 14% and until 55%,~     such is the case of Mexico. Meanwhile use of antibiotics for 3 to 7 days had established as a~     standard of care, the use of non-antibiotic therapy, such as cranberry powder or probiotics~     for prevention/treatment of this conditions is scarce. Randomized controlled trial aimed to~     evaluate the safety and efficacy of probiotic vs. antibiotics to treat pregnant women with~     uncomplicated cystitis or asymptomatic bacteriuria~   "
15624|NCT03362411|"~     The purpose of this study is to evaluate the absorption of BMS-986205 into the bloodstream of~     healthy volunteers, when administered as an intact tablet taken orally, or as a crushed~     tablet taken orally with soft food, or as a crushed tablet suspension taken via a nasogastric~     (NG) tube. Eligible participants will be randomly assigned to 1 of 4 treatment sequences and~     will receive a single dose of BMS-986205 twice during the course of the study.~   "
15603|NCT03362684|"~     This is a prospective-retrospective study to determine if the expression of the miRNA's~     miR-31-3p and miR-31-5p are prognostic of patient outcomes or predictive of the benefit from~     anti-EGFR therapy in stage III Colon Cancer. The present study will utilize FFPE tumor~     samples collected from patients enrolled in the PETACC-8 study conducted by the Fédération~     Francophone de Cancérologie Digestive (FFCD). This phase 3 clinical trial prospectively~     randomized fully resected stage III colon cancer patients to receive adjuvant treatment with~     either FOLFOX-4 plus cetuximab or FLOFOX-4 alone.~   "
15604|NCT03362671|"~     Mandibular advancing oral appliances (OAm) are an effective and increasingly common treatment~     modality for the management of obstructive sleep apnea (OSA) in adults.~      The effectiveness of OAm therapy, however, is dependent on a high level of patient adherence,~     which may be negatively impacted by treatment side effects - the most significant of which~     are occlusal changes and tooth movement.~      The proposed pilot study will evaluate the efficacy of a novel implant supported OAm in 10~     OSA patients who have already been successfully treated with a traditional OAm.~      The study will compare OSA specific outcomes with traditional OAm use against novel oral~     appliance use after one month. This study could potentially validate the novel design~     features of an effective treatment option for OSA that does not result in tooth movement,~     which is a significant side effect shared by all existing OAm devices.~      Ultimately, this study could lead to increased treatment adherence and better OSA patient~     health outcomes in the future.~   "
15605|NCT03362658|"~     Routine MRI is normal in motor neuron diseases such as ALS. However, advanced MRI techniques~     can provide an objective measure of degeneration (a biomarker) by examining brain~     structure, wiring, chemistry, and function. We will develop and evaluate novel MRI techniques~     that could improve our understanding of ALS and provide a means to diagnose it sooner and~     monitor its progression. Importantly, we expect these techniques to improve how new drugs are~     tested, which may lead to the more rapid discovery of a treatment for ALS.~      Each participant will have 3 MRI scans over a period of 8 months, along with neurological and~     cognitive evaluations. Study visits will take 2 - 3 hours. MRI is a safe technique that does~     not involve radiation.~   "
15606|NCT03362645|"~     Cardiac complications occur in 78% of patients with Fabry disease and are mainly~     characterized by a high frequency of left ventricular hypertrophy resulting from an~     accumulation of GL3 in cardiomyocytes. Apart from family screening, left ventricular~     hypertrophy is an important factor in the diagnosis of Fabry disease. This left ventricular~     hypertrophy is more often concentric and homogeneous, but it can also be asymmetric and mimic~     the patterns seen in so-called familial hypertrophic cardiomyopathies caused by mutations in~     the sarcomere protein genes. Electrocardiogram has been suggested as a screening tool for~     Fabry disease. Analysis of the PQ interval would be of interest. An algorithm has even been~     proposed to differentiate Fabry disease from amyloidosis with excellent sensitivity and~     specificity. The only criterion of left ventricular hypertrophy used in all studies is the~     Sokolov-Lyon index, but this index has many limitations and does not appear to be~     discriminatory for Fabry disease. Other validated criteria for left ventricular hypertrophy,~     such as the Cornell, Lewis, Gubner index or the Romhilt-Estes point score, have never been~     tested in Fabry disease. The primary objective of our study is to evaluate the diagnostic~     value of different electrocardiographic scores of left ventricular hypertrophy in Fabry~     disease.~   "
15607|NCT03362632|"~     Spontaneous bacterial peritonitis (SBP) is a common complication of end-stage liver disease~     due to various causes. The initial anti-infective medication is appropriate and the patient's~     survival rate is closely related. Ascitic fluid bacterial culture takes a long time, the~     positive rate is low, it is difficult to guide the timely use of antimicrobial drugs,~     empirical medicine based on evidence-based medicine for SBP in patients with end-stage liver~     disease is essential. The American College of Hepatology and the European Society of~     Hepatology recommend the use of third-generation cephalosporins as the first choice of~     empirical therapy in patients with end-stage liver disease associated with community-acquired~     SBP. Patients with merger of hospital-acquired SBP with piperacillin / tazobactam or~     carbapenem +/- glycopeptide antibiotics is the first choice for empirical medication. There~     is no clear recommendation in China. In recent years, the conclusions of international~     clinical research in this area have been in disagreement with the recommendations. As a key~     factor in the selection of empirical antibiotics is local bacterial resistance data, these~     findings are difficult to evidence-based medicine for Chinese doctors. This project intends~     to observe the efficacy of different initial anti-infective regimens in Chinese patients with~     end-stage liver disease with SBP and 30-day and 60-day non-liver transplant survival rates,~     providing evidence-based medical evidence for the empirical use of such patients.~   "
15608|NCT03362619|"~     The primary objective of this study is to evaluate the safety of cervical cancer specific~     engineered immune effectors (CC-EIEs). The secondary objectives are to evaluate the rate of~     successful CC-EIE generation in vitro and determine the anti-CC efficacy.~   "
15609|NCT03362606|"~     This is a single-arm, open-label, phase I/II trial to evaluate the safety and efficacy of~     ovarian cancer specific cytotoxic lymphocytes (OC-CTLs) in women.~   "
15610|NCT03362593|"~     This is a 4-part study to evaluate the safety, tolerability, and PK of MEDI7219 in healthy~     subjects. Parts A through C are the single-dose parts of the study. Part D is the multiple~     ascending dose (MAD) part of the study. The starting dose and formulation for Part D will be~     selected from data emerging from Parts A and B. Enrollment of approximately 106 subjects is~     anticipated.~   "
15611|NCT03362580|"~     Numerous terms have been used to describe epiretinal membrane (ERM): macular pucker,~     epimacular membrane, surface-wrinkling retinopathy, cellophane maculopathy and preretinal~     macular fibrosis. It is, by definition, a fibrocellular tissue found on the inner surface of~     the retina. It is semi-translucent and proliferates on or above the surface of the internal~     limiting membrane. It causes blurring and metamorphopsia, while mild cases are often~     asymptomatic.~      ERM presence can degrade the acuity and the quality of vision, thus affecting the quality of~     life. There is evidence that it also has an adverse impact to the treatment options for~     patients suffering from macular disorders. More specifically, regarding to diabetic~     retinopathy, ERM seems to have a bidirectional etiopathogenetic relationship with its course~     and complications.~      The aim of this study is to know the prevalence of ERM in the Brussel's population, the risk~     factors predisposing to ERM formation and if diabetic patients have a significantly higher~     prevalence of ERM in comparison to general population.~   "
15612|NCT03362567|"~     Sustained natural apophyseal glides (SNAGS), is a form of manual therapy, involved a~     combination of a sustained facet glide with active motion, followed by overpressure. Natural~     apophseal glides (NAGS), a modification of SNAGS, involves a mid to end-range facet joint~     mobilisation applied anterocranially or posterioanteriorly along the plane of treatment,~     combined with a small amount of manual traction which increases movement within the spine,~     and decreases symptomatic pain . A study reported that Natural Apophyseal Glides (NAGS) and~     Sustained Natural Apophyseal Glides (SNAGS) demonstrated significant effects in reducing pain~     and disability in subjects with chronic neck pain . This technique, SNAGS, is however an~     evolving manual therapy techniques which its effectiveness has not been thoroughly~     investigated in cervical radiculopathy treatment raised author's curiosity to compare and~     document efficacy of SNAGS with cervical traction in Nigeria since comparative studies~     evaluating SNAGS and manual cervical traction relative efficacies among Nigerians are yet to~     be documented if at all available. Consequently, the quest is to look for a quicker and a~     better way of relieving cervical radiculopathy in this environment . The more reason why we~     have to compare it with a conventional mechanical traction.~   "
15613|NCT03362554|"~     Diabetes is a chronic metabolic disease affecting 415 million people worldwide, 90% of cases~     are type 2 which is frequently associated with obesity and a sedentary lifestyle. In healthy~     individuals, insulin stimulates increased cell surface expression of a glucose transporter~     (GLUT4) in muscle and fat tissue. This prevents blood sugar levels becoming dangerously high~     by taking sugar into the muscle and fat cells. Loss of this response ('insulin resistance')~     frequently occurs before the development of type 2 diabetes. Understanding the cell biology~     of insulin resistance is necessary to develop more effective treatments for this condition~     and prevent further cases of type 2 diabetes. Previous work showed that this movement of~     GLUT4 is dependent on a small protein called Rab3 which is downregulated in insulin~     resistance. Rab3 protein levels are also sensitive to inflammation, a state that is~     exacerbated by obesity.~      In order to examine whether Rab3 is an early biomarker of insulin resistance, we aim to~     measure the levels of this protein and its interactors in fat and muscle samples from insulin~     resistant individuals. It has been shown that insulin sensitivity can be improved with an~     intervention as short as three weeks when net energy intake is sufficiently reduced.~     Therefore, by taking the same measurements before and after this three week intervention we~     can observe any improvements in Rab3 expression and insulin sensitivity at a cellular level.~      There is also evidence for an effect of the gut microbiome on insulin sensitivity so we will~     measure any changes that take place in the gut microbiome following this intervention, which~     can be determined from faecal samples taken before and after the three weeks.~   "
15614|NCT03362541|"~     People with MS commonly experience extreme fatigue that negatively impacts their ability to~     engage in a full range of daily activities, quality of life, and employment. A new website~     called MS INFoRm (Multiple Sclerosis: An Interactive Fatigue Management Resource) allows~     people with MS to take a personalized and active approach to learning about and managing~     their fatigue. The aims of this study are:~        1. To determine to determine whether 3-month use of the MS INFoRm website can reduce the~          impact of fatigue on daily life among persons with MS.~        2. To determine whether 3-month use of the MS INFoRm website results in improvement in~          self- efficacy/ confidence for managing MS fatigue, self-reported cognitive function,~          participation and autonomy/ independence, and depression.~        3. To determine whether benefits are maintained among the MS INFoRm users after 6-months.~   "
15615|NCT03362528|"~     This clinical study has been launched to collect spectral raman data paired with validated~     glucose reference values in private homes of subjects.~   "
15616|NCT03362515|"~     Prior studies have suggested that topical furosemide may reduce the recurrence of sinonasal~     polyposis following sinus surgery. This project aims to further investigate that claim~     through a blinded randomized controlled clinical trial following patients who undergo~     functional sinus surgery for chronic rhinosinusitis with sinonasal polyposis by randomly~     assigning participants to receive topical furosemide versus placebo nasal spray for 2 months~     post operatively. Outcomes would be compared at 6 months through endoscopic grading scores~     using Lund Kennedy and Meltzer scores as well as Sino-Nasal Outcome Test (SNOT-22) scores to~     measure the rate and degree of recurrence and impact on symptoms in the treatment group~     versus placebo.~   "
15617|NCT03362502|"~     This is a first-in-human/first-in-patient, multi-center, open-label, non-randomized,~     ascending dose, safety and tolerability study of a single intravenous infusion of PF-06939926~     in ambulatory subjects with Duchenne muscular dystrophy (DMD). Other objectives include~     measurement of dystrophin expression and distribution, and assessments of muscle strength,~     quality, and function.~      Two dose cohorts are planned with up to 6 subjects for each. In order to mitigate~     unanticipated risks to subject safety, enrollment will be staggered within and between the~     two cohorts and will include a formal review by an external data monitoring committee (E-DMC)~     prior to dose progression.~   "
15618|NCT03362489|"~     The purpose of this study is to compare the efficiency of conversion to IUI and IVF in~     patients with a poor ovarian response to stimulation~   "
15619|NCT03362476|"~     The study will harness the multidisciplinary expertise to adapt an effective alcohol~     reduction computer-based intervention, called CBT4CBT, to enhance its appropriateness for~     HIV/HCV co-infected women and evaluate its efficacy. The intervention, if effective, may be~     an efficient and cost-effective alcohol reduction strategy, that is scalable and can be~     readily disseminated and integrated in clinical care at other AIDS Centres in Russia to~     enhance women's health and reduce HIV/HCV transmission risk.~   "
15620|NCT03362463|"~     A multinational, prospective and observational study that will assess the management of ACS~     in real-life practices in Middle East North Africa area.~   "
15621|NCT03362450|"~     Objective:~      The small bowel volvulus is a rare cause of intestinal obstruction which may occur in utero~     and whose prenatal diagnosis is difficult.Sonographic signs are mainly indirect and non~     specific.The aim of this study is to present a retrospective analysis of prenatal~     sonographicfindings in fetal segmental midgut volvulus.Thanks to this series the~     investigators could highlight the more specifics signs of the volvulus included a new~     pattern.~   "
15622|NCT03362437|"~     Assess the pharmacokinetics (fasting and fed), safety, and tolerability of BMS-986177~     following oral dosing of Form A and Form B~   "
15625|NCT03362398|"~     The proposed study will consider the LC-MS/MS quantitative determination of Omarigliptin &~     Trelagliptin after administration to twelve Egyptian volunteers. The main aim of the study is~     to confirm that the developed LC-MS/MS method is applicable for the bio-assay of the drugs in~     the actual biological samples at the time of Cmax (nearly about 1.5 hours). The design of the~     study is open labeled, randomized, one treatment, one period, single dose study. The~     concentration of the drugs after 1.5 h will be determined in healthy human subjects according~     to the ethical regulations of World Medical Association Declaration of Helsinki (October~     1996) and the International Conference of Harmonisation Tripartite Guideline for Good~     Clinical Practice. Written informed consent was provided (attached and signed by the twelve~     volunteers) in order to be approved by the ethics committee of the Faculty of Pharmacy, The~     British University in Egypt. The good health of the human subjects was confirmed by a~     complete medical history and physical examination. Samples from twelve, healthy, adult, male,~     smoking, Egyptian volunteers (age: 23-37 years, Average weight: 81.6 kg, Average BMI: 30.4)~     will be collected at 1.5 h, to be transferred to heparinized centrifuge tubes in order to be~     analyzed by LC-MS/MS study (developed & validated) after single oral dose administration of~     one Marizev® tablet nominally containing 25 mg of Omarigliptin (first arm as 6 volunteers) or~     one Zafatek® tablet nominally containing 100 mg of Trelagliptin (second arm as 6 volunteers).~     The blood samples (0.5 mL of each sample) will be centrifuged at 3000 rpm for 5 minutes, 100~     µL of the plasma will be separated and spiked with the internal standard working solution and~     then the sample preparation and LC-MS/MS determination will be applied. Blood glucose level~     will be determined for all volunteers at different time intervals to monitor any hypoglycemic~     effect to ensure their safety all over the study. The study will be conducted as per FDA~     guidelines & the evaluation of safety of the study will be based on monitoring of blood~     glucose level, vital signs, pulse rate, monitoring of adverse events, and physical~     examination.~   "
15626|NCT03362385|"~     Obstructive sleep apnea (OSA) is an increasingly common chronic disorder in adults that has~     been strongly associated with various forms of cardiovascular disease. Compared to the~     general population, OSA occurs more often in patients with acute coronary syndrome (ACS).~     Although percutaneous coronary intervention (PCI) is nowadays part of standard therapy and~     optimal medical therapy has been used to manage traditional risk factors, the long-term~     cardiovascular outcomes after index ACS remain suboptimal.~      Some preliminary data suggest OSA is associated with higher risk of subsequent cardiovascular~     events in ACS patients. However, the study population was heterogeneous and these studies~     were not done in the context of new-generation drug-eluting stents and intensive antiplatelet~     therapy, thus precluding definite conclusions. Furthermore, a cardioprotective role of OSA in~     the context of acute myocardial infarction (AMI), via ischemic preconditioning, has also been~     postulated.~      Due to the inconsistent evidence, the investigators performed a large-scale, prospective~     cohort study to delineate the whole picture of the association of OSA with short- and~     long-term outcomes of patients with ACS. Whether treatment of OSA (eg. continuous positive~     airway pressure (CPAP)) would prevent these events will also be evaluated. Moreover, the~     investigators will assess the potential mechanisms of OSA-induced atherosclerosis and~     myocardial injury in ACS patients.~   "
15627|NCT03362372|"~     Several studies have shown the influence of the eating pattern on lung function. However, the~     benefits of the Mediterranean diet (DiMet) in preventing pulmonary dysfunction are not well~     known.~      Objective: To evaluate the effect of adherence to DiMet on the deterioration of lung function~     in smokers.~      Methodology: Design: Controlled, parallel, multicenter, cluster-randomized clinical trial.~     Participants: 750 active smokers with a cumulative consumption of more than 10 packets a~     year, within 25 to 75 year-old age group, without previous respiratory disease and who agree~     with the conditions of the study and sign an informed consent . Scope: 20 Primary Care~     Centers managed by the Catalan Health Institutes in Tarragona that will be randomly assigned~     to a control or an intervention group (1: 1). Intervention: During 2 years a nutritional~     intervention will be carried out to increase adherence to DiMet based on: 1) annual visit of~     personalized nutritional education, 2) annual telephone contact for intervention~     reinforcement, and 3) computer access to a dietary block designed ad hoc. The control group~     will follow their usual diet style. All participants will receive advice to quit smoking. It~     will be evaluated: a) pulmonary function by forced spirometry and b) adherence to the DiMet~     with a questionnaire of 14 items and biological determinations. Statistical analysis: For~     intention to treat. The unit of analysis will be the individual smoker. Parameters of~     pulmonary function and adherence to the DiMet of both groups will be compared.~      Expected results: DiMet prevents the appearance of altered lung function in smokers without~     previous respiratory pathology. Thus, DiMet will be key in pulmonary prevention, together~     with the fundamental recommendation of smoking cessation.~   "
15628|NCT03362359|"~     This will be an open-label, single-arm, rater-blinded, multicenter, diagnostic phase 1/2~     study to assess safety and diagnostic performance of Ga-68-PSMA-11 positron emission~     tomography / computer tomography (PET/CT) imaging to detect tumour tissue in patients with~     newly diagnosed PCA and a high risk for metastasis. As standard of truth, comprehensive~     histopathology covering prostate and the tributary pelvic lymph node system, will be used.~     Therefore, only patients scheduled for RP with EPLND (as part of their standard of care) will~     be eligible.~      Patients will be recruited at up to 11 uro-oncological sites in Germany, Austria, and~     Switzerland, with access to a radiopharmaceutical laboratory, experienced to prepare~     68Ga-labelled compounds, and high-quality PET/CT imaging. Upon histological confirmation of~     PCA, pre-operative staging will be performed according to European Association of Urology~     (EAU) guideline [Mottet et al. 2015] (to include pelvic MRI or CT and a 99mTc-bone scan), to~     establish the indication for RP with EPLND. If the indication is confirmed, patients will be~     invited to participate in the present study. After consenting, review of inclusion and~     exclusion criteria, as well as screening investigations will be performed by the~     uro-oncologist (day 0). Thereafter, patients are referred to the collaborating nuclear~     medicine department for tracer injection, imaging, and post-dose safety evaluations (day 1).~     Subsequent investigations (day 2 and at end of study) will be made by the uro-oncologist or~     experienced nuclear medicine physician. Study participation ends on day 7. Routine surgery~     (RP with EPLND) will be performed after end of study, but no later than 21 days after study~     inclusion. This sequence allows adequate characterisation of tracer safety, while at the same~     avoiding unnecessary delay of, or confounding safety signals from therapy.~      In total, 150 evaluable patients will be included to receive a single 68Ga dose of 150 MBq (±~     50 MBq), administered as i.v. infusion. Due to an assumed dropout rate of 15%, up to 173~     patients will be included in study.~   "
15629|NCT03362346|"~     The project uses big data analysis techniques such as wavelet transform and deep learning to~     analyze physiological signals from neurocritical patients and build a model to evaluate~     intracranial condition and to predict neurological outcome. By identification of correlations~     among these parameters and their trends, we may achieve early detection of anomalies and~     enhance the ability in judgement of current neurological condition and prediction of~     prognosis. By continuous input of the past and contemporary data in the ICU, the model will~     be modified repeatedly and its accuracy improves as the model grows. The model can be used to~     recognize abnormalities earlier and provide a warning system. Clinicians taking care of~     neurocritical patients can adjust their treatment policy and evaluate the outcome according~     to such system.~   "
15630|NCT03362333|"~     This study examined the effects of pain neuroscience education plus exercise when compared~     with exercise only in university students with chronic idiopathic neck pain.~   "
15631|NCT03362320|"~     Retear rates after arthroscopic rotator cuff repairs remain unsatisfactorily high. Recently,~     attention has been paid to restore the rotator cuff's native anatomy by reconstructing the~     superior joint capsule. However, the debate whether to reconstruct only the superficial~     tendinous part or also the deeper capsulo-ligamentous part of the rotator cuff is ongoing.~     Thus, the intention of the present study is to compare double-layer versus single-layer~     arthroscopic rotator cuff repair regarding retear rate and clinical outcome.~   "
15632|NCT03362307|"~     Subjects were assigned in two groups: In group 1, subjects received LLL and LED 20 min/day~     for 10 days after implant insertion, subjects in group 2did not undergo LLL and LED. implant~     stability quotients(ISQs) were measured in 0,10,21,42 and 63 days after implant placement.~   "
15633|NCT03362294|"~     This is a phase IIa study with GA Depot in subjects with Primary Progressive MS. GA Depot~     will be administered intramuscularly (IM), once every four weeks for 52 weeks.~      The purpose of this study is to assess the safety and efficacy of GA Depot to slow the~     accumulation of disability progression in subjects with Primary Progressive MS.~   "
15634|NCT03362281|"~     The purpose of this phase study is to confirm the efficacy and safety by compare ilaprazole~     and omeprazole in the treatment and prevention of peptic ulcer bleeding. Patients with~     endoscopically diagnosed peptic ulcer bleeding were enrolled in a multi-center, stratified~     randomized, non-inferiority test, double-blind, parallel and positive-controlled trial. They~     were randomly assigned into two groups, ilaprazole and omeprazole, to be treated for up to 30~     days. The primary endpoint was the hemostasis rate at the end of 72 hours. Secondary end~     points include ulcer staging changes within 72 hours, effective rate of hemostasis,~     hemostasis duration, average blood transfusion and rebleeding rate, etc.~   "
15635|NCT03362268|"~     The purpose of this study is to compare the efficacy and safety of ilaprazole and omeprazole~     in the treatment and prevention of peptic ulcer bleeding. Patients with endoscopically~     diagnosed peptic ulcer bleeding were enrolled in a randomized, double-blind, parallel and~     positive-controlled trial. They were randomly assigned into two groups, ilaprazole and~     omeprazole, to be treated for up to 30 days and be seen at day 3, 4, 7, 14 and 30. The~     primary endpoint was the hemostasis rate (hemostatic groups with endoscopy check ) and~     re-bleeding rate ( bleeding groups with endoscopy check) within 72 hours. Secondary end~     points include effective rate of hemostasis, mean volume of blood transfusion, the length of~     stay and re-bleeding rate, etc.~   "
15636|NCT03362255|"~     It is reported that optic nerve sheath diameter increases when higher volume of medication is~     injected during epidural anesthesia.~      This study is designed to compare the optic nerve sheath diameter using 10cc of nomal saline~     of different speed (3cc/sec vs. 1cc/sec).~   "
15637|NCT03362242|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and~     pharmacodynamics of single- and multiple-ascending doses of ARO-AAT in healthy adult~     volunteers.~   "
15638|NCT03362229|"~     Medial malleolus: Operative Or Non-operative (MOON study) Ankle fractures are a common~     Orthopaedic trauma presentation, accounting for approximately 10% of the workload. There has~     been debate regarding the significance of the contribution of the medial malleolus to ankle~     stability. Some deem the lateral malleolus as the key stabiliser. With this anatomically~     aligned the ankle joint should be stable. Operating on the medial malleolus fracture often~     requires a second generous skin incision, soft tissue stripping and insertion of metalwork.~     This carries with it the risk of wound complications, infection and increased operation time.~     High risk patients including the elderly, diabetics and those with significant swelling~     following injury are particularly vulnerable. The study will include adult patients (≥16~     years) with capacity to consent and complete post-operative questionnaires, presenting to a~     single Orthopaedic trauma unit. Participants will be randomised to fixation or non-fixation~     of associated medial malleolus fractures at the same time as fixation of the lateral~     malleolar fracture to assess if this impacts on validated patient outcomes, failure,~     operative time and complications over a one-year follow-up. Only one trial has been~     published, showing no significant difference between failure rates or outcomes, but reduced~     operative time.~      Participants will be enrolled into the trial following informed consent. The final decision~     on whether a participant is eligible can only be made during surgery when the medial~     malleolus fracture has reduced with no more than 2mm displacement. If this is confirmed the~     participant will be randomised to receive either fixation or non-fixation of the medial~     malleolus. Randomisation therefore occurs at the time of surgery. Participants will be~     reviewed at set post-operative checkpoints, with X-rays and patient reported outcome scores.~     Trial data will hopefully enable surgeons to make better informed decisions when managing~     patients with ankle fracture dislocations.~   "
15639|NCT03362216|"~     This clinical trial program was established according to the ethical principles of the~     Helsinki declaration and the GCP guiding principle, and a randomized grouping method was used~     to evaluate the efficacy and safety of Compound Methyl Salicylate Liniment in the treatment~     of acute and chronic soft tissue pain with a positive control drug, named Diclofenac Sodium~     Liniment.~   "
15640|NCT03362203|"~     The aim of this study was to evaluate changes in local and segmental hypersensitivity and~     endogenous pain inhibition in people with chronic nonspecific neck pain.~   "
15641|NCT03362190|"~     To assess the safety of intravitreal Zimura™ (complement factor C5 inhibitor) administered in~     combination with Lucentis® 0.5 mg in treatment naïve subjects with neovascular age related~     macular degeneration (NVAMD)~   "
15642|NCT03362177|"~     Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects with~     Gastrointestinal or Colorectal Cancer~   "
15643|NCT03362164|"~     This study evaluates predictors for the incidence of arrhythmias and sudden cardiac death as~     well as terminal heart failure in patients with Fabry disease.~   "
15644|NCT03362151|"~     The aim of this clinical study is to investigate and compare the postprandial glycemic~     response to three different meal types rich in carbohydrates, that is, white pasta, high~     protein pasta and white rice consumed by individuals with T1DM.~   "
15691|NCT03361540|"~     The objective of this study is to evaluate the safety, tolerability and pharmacokinetic of~     single/multiple ascending oral doses of ASP8302 in non-elderly healthy Japanese male and~     female subjects.~   "
15692|NCT03361527|"~     The goal of the study is to determine the benefit in speech intelligibility of the BBF and~     the MBF compared to an omni-directional microphone in different noise conditions. Secondary~     objective is to determine if there is a subjective preference for one of the microphone~     settings in different noise conditions.~   "
15693|NCT03361514|"~     To investigate the effectiveness of the combination of Supported Protocolized Discontinuation~     (SPD) and Mindfulness-Based Cognitive Therapy (MBCT) in comparison with SPD alone in~     successful discontinuation of long-term use of antidepressants in primary care.~   "
18331|NCT03326986|"~     The purpose of this study is to assess the safety, tolerability and pharmacokinetics of~     MK-7252 in healthy adults. Participants receive ascending doses of MK-7252 over five~     treatment periods. Each treatment period is separated by a 7-day washout period.~   "
15645|NCT03362138|"~     Malignant melanoma (MM) is a deadly cancer, claiming globally about 160000 new cases per year~     and 48000 deaths at a 1:28 lifetime incidence (2016).~      The golden standard, dermoscopy, enables Dermatologists to diagnose with a sensitivity of~     40%, and a 8-12% specificity, approximately. Additional diagnostic abilities are restricted~     to devices which are either unproved or experimental.~      A new technology of Neuronal Network Clinical Decision Support (NNCD) was developed. It uses~     a dermoscopic imaging device and a camera able to capture an image. The photo is transferred~     to a Cloud Server and further analyzed by a trained classifier. Classifier training is aimed~     at a high accuracy diagnosis of Dysplastic Nevi (DN), Spitz Nevi and Malignant Melanoma~     detection with assistance from a Deep Neuronal Learning network (DLN). Diagnosis output is an~     excise or do not excise recommendation for pigmented skin lesions.~      A total of 80 subjects already referred to biopsy pigmented skin lesions will be examined by~     dermoscopy imaging in a non interventional study. Artificial Intelligence output results, as~     measured by 2 different dermoscopes, to be compared to ground truth biopsies.~      Primary endpoints are sensitivity and specificity detection of the NNCD techniques. Secondary~     endpoints are the positive and negative prediction ratios of NNCD techniques.~   "
15646|NCT03362125|"~     Evaluation of Wang's score as a predictor of the duration of oxygen therapy in bronchiolitis~   "
15647|NCT03362112|"~     Lipoprotein-associated phospholipase A2 (LP-PLA2) is a good marker of cardiovascular risk and~     inflammation. This study aims at the characteristic and clinical significance of LP-PLA2 test~     in patients with type 2 diabetes(T2D).~   "
15648|NCT03362099|"~     Smoking is the leading cause of avoidable death in the world. Smoking is associated with the~     development of cardiovascular and respiratory diseases, as well as being considered a leading~     cause of cancer death. Data show that smokers have increased cardiovascular risk in relation~     to former smokers, even in comparison with individuals who have had a long and intense~     history tobacco use.~      Considering this scenario, some drugs are used in tobacco cessation therapy. The first-line~     anti-smoking treatments approved by the Food and drug administration ( FDA ) are nicotinic~     reuptake therapy, bupropion ( norepinephrine and dopamine reuptake inhibitor) and varenicline~     ( partial agonist of nicotinic receptors composed of subunits alpha4Beta2 ). A metanalysis of~     16 clinical studies indicated that smokers treated with bupropion had a higher abstinence~     rate compared to those receiving placebo - Odds ratio (OR ) - of 1,97 for treatment success.~      Varenicline is more effective compared to others smoking cessation drugs approved by the FDA,~     with an OR of 2,27 ( IC 95% 2,02-2,55 ) compared to placebo. However, Varenicline is much~     more expensive than bupropion.~      Significant advances in genetics have made the variability of the individual response to~     drugs, as far as efficacy as well as the rate of adverse effects, begin to be specifically~     investigated through pharmacogenetics studies.~   "
15649|NCT03362086|"~     Osteosarcoma is very rare bone tumor. The investigator set up the biobank to ensure the~     patients has the chance to participate in future research~   "
15650|NCT03362073|"~     To establish the role of ketamine in hospitalized terminally ill cancer patients with~     refractory cancer pain, using continuous intravenous infusion of ketamine~   "
15651|NCT03362060|"~     This research study is studying immunotherapy as a possible treatment for metastatic Triple~     Negative Breast Cancer (TNBC) in participants who are HLA-A2+.~      The drugs involved in this study are:~        -  PVX-410~        -  Pembrolizumab~        -  Hiltonol~        -  Montanide~   "
15652|NCT03362047|"~     Pilot study to determine the therapeutic effect of two prarallel groups treated with either~     Riciguat or Macitentan, evaluated by the change in systolic and diastolic RV function within~     12 weeks after first drug intake in order to plan a larger Phase II study.~   "
15653|NCT03362034|"~     compare the chairside time and the accuracy of transferring attachments between single and~     double sheets vacuum tray techniques during indirect bonding of orthodontic attachments using~     superimposition on computer software~   "
15654|NCT03362021|"~     The effects of two different sedation protocols during transvaginal oocyte retrieval will be~     investigated on propofol consumption as a rescue sedative and on IVF success. One group will~     receive dexmedetomidine and fentanyl while the other will receive midazolam and remifentanil.~   "
15655|NCT03362008|"~     This study is a randomized, open-label, 2-way, 2-period, single-dose crossover clinical study~     to compare the pharmacokinetic characteristics and the safety between zeropix tablet 1 mg and~     champix® tablet 1 mg in healthy adult male subjects~   "
15656|NCT03361995|"~     A Multicenter, Prospective, Randomized-Controlled Trial to Assess Cooling as an Adjunctive~     Therapy to Percutaneous Intervention In Patients with Acute Myocardial Infarction. This is a~     two-arm trial enrolling up to 40 patients in each arm for a total of 80 patients at up to 10~     clinical centers.~   "
15657|NCT03361982|"~     The primary objective of this study is to determine if the use of frozen surgical testicular~     sperm specimens for ICSI lead to different IVF outcomes when compared with the use of fresh~     surgical testicular sperm for ICSI.~   "
15658|NCT03361969|"~     This is a phase IIa, double-blind, randomised, placebo-controlled, multi-center study to~     evaluate the effects of estetrol on testosterone suppression and quality of life in prostate~     cancer patients treated with an LHRH agonist. Patients will be treated with estetrol or~     placebo for 6 months.~   "
15659|NCT03361956|"~     The purpose of this study is to evaluate efficacy of 24 weeks of study treatment, in terms of~     changes in hepatitis B surface antigen (HBsAg) levels.~   "
15660|NCT03361943|"~     The study uses data from the NHANES surveys to evaluate trends in SSB intakes among US~     children. The goal was to determine whether recent declines in intake may have been less~     marked in the more vulnerable groups with a persistently high burden of obesity, including~     race/ethnic minorities and low-income groups.~   "
15694|NCT03361501|"~     The primary objective of this study is to determine the efficacy of CaPre 4 g daily, compared~     to placebo, in lowering fasting TG levels in subjects with fasting TG levels ≥500 mg/dL and~     ≤1500 mg/dL (≥5.7 mmol/L and ≤17.0 mmol/L) after 12 weeks of treatment.~      Approximately 615 subjects will be screened to obtain 245 randomized subjects following a~     treatment allocation ratio of 2.5:1 (CaPre:placebo).~   "
15695|NCT03361488|"~     The preanesthetic visit influences patient satisfaction and medical outcome. This study aims~     to evaluate whether training for a structured interview technique improves communication~     skills, resulting in increased recall of relevant information by surgical patients.~   "
15661|NCT03361930|"~     The aim of this study is to investigate if ankle-foot orthoses affect changes in muscle~     activity of children with spastic unilateral cerebral palsy during walking.~      To minimize investigator variability, the same orthotist CO, clinical gait analyst GA and~     physiotherapist PT will perform their designated functions for all participants.~      Each subject will be required to attend three appointments.~      First appointment: CO takes a lower leg cast of the involved side; the cast is taken with the~     ankle and hindfoot corrected to neutral position.~      Second appointment: CO fits the tone-reducing ankle-foot orthosis which entails trimming the~     device to fit footwear, checking the orthotic device restricts plantarflexion and ensuring~     comfortable and functional fit. The device is modified with holes for electrode placement at~     locations for tibialis anterior and gastrocnemius identified by PT.~      The child receives the tone-reducing ankle-foot orthosis and is instructed to use this~     orthotic device on a daily basis for the next four weeks to grow accustomed to the~     tone-reducing stimuli which may require some acclimatization.~      Third appointment: A clinical examination is conducted by PT. Surface gel electrodes are then~     attached while the participant is instructed in individual muscle activation tests; SENIAM~     guidelines will be followed for electrode placement and skin preparation, aside from~     hamstrings and rectus femoris which will follow amended instructions in line with the~     scientific literature.~      GA quality checks the raw electromyography (EMG) signals by visual inspection during the~     isolated muscle activation tests and during a dynamic trial for movement artefacts,~     cross-talk, baseline drift and good noise-to-signal ratio.~      Reflective markers are then applied in accordance with Plug-in Gait lower body model by PT to~     collect kinematic and kinetic data.~      A resting trial is collected to establish the baseline activity level for each muscle.~      The participant is instructed to walk at a self-selected speed along the walkway. Dynamic~     trials continue until two clean strikes to the middle force plate are collected for the~     involved leg. Barefoot data is collected first while any additional modifications necessary~     for electrode placement are made to the ankle-foot orthoses. The order of the orthotic~     conditions is randomized.~      Data will be recorded confidentially using reference codes for participants and stored on a~     secure server with designated space allocated by the hospital.~   "
15662|NCT03361917|"~     This study seeks to compare colonoscopy results between a standard method and one using a~     distal scope attachment (Endocuff Vision).~   "
15663|NCT03361904|"~     Current recommendations for colonoscopy screening programs usually involve patients older~     than 50 years of age. However, little is known about polyp or adenoma detection rates under~     50. We compared these detection rates according to age in a large series of patients in~     common practice.~      Methods: All colonoscopies performed in 2016 in our unit were prospectively recorded. We~     determined adenoma detection rate (ADR), polyp detection rate (PDR), mean number of polyps~     (MNP), and advanced neoplasia detection rate (ANDR).~   "
15664|NCT03361891|"~     Patients admitted to hospital typically experience periods of decreased activity or bed-rest.~     This reduced activity level leads to deconditioning - a loss of muscle mass, muscle strength~     (by 2-5% per day), and muscle shortening. Even among patients who were ambulatory at the time~     of admission, deconditioning has been linked with deleterious effects, such as increased~     rates of falls, functional decline, and frailty. Furthermore, it has been suggested that the~     physiological stresses associated with hospitalization - including deconditioning, as well as~     sleep deprivation and poor nutrition - makes discharged patients vulnerable to recurrent or~     new illnesses and to frailty. This physiological stress-induced vulnerability has been coined~     post-hospital syndrome and is thought to have a role in most hospital readmissions.~      The investigators hypothesize that by engaging ambulatory patients to walk with trained~     volunteer coaches, patients will increase their amount of walking, have less deconditioning~     and functional decline, and consequently, fewer falls. Furthermore, the investigators~     anticipate that patients who walk with a trained coach will have reduced length-of-stay in~     hospital and decreased likelihood of readmission. Finally, as shown in other programs~     trialing health coaches, the investigators anticipate an overall improvement in the patient~     experience.~      Our aim is to demonstrate the feasibility of an intentional walking protocol called WalkMORE,~     which pairs trained volunteer coaches with ambulatory patients admitted to the Internal~     Medicine unit (4th floor University Hospital), aimed at decreasing deconditioning through~     increased walking.~   "
15665|NCT03361878|"~     Pharmacokinetic study of metformin intolerance~   "
15666|NCT03361865|"~     The purpose of this study is to evaluate the efficacy and safety of pembrolizumab +~     epacadostat vs pembrolizumab + placebo in participants with cisplatin-ineligible urothelial~     carcinoma.~   "
15667|NCT03361852|"~     This research study is studying a novel type of FL vaccine as a possible treatment for~     follicular lymphoma (FL).~      The agents involved in this study are:~        -  Personalized NeoAntigen vaccine~        -  Poly-ICLC~   "
15668|NCT03361839|"~     clinical trial to improve pregnancy outcome in patient with RLF , study done on 2 phases.~     phase 1 to study variations of endometrial receptivity genes in this group of patient, phase~     2 repeat cycle or transfer frozen embryo in proper time and after giving proper treatment~   "
15669|NCT03361826|"~     Suicide is a major public health crisis for which effective new interventions are needed. An~     innovative new brain stimulation technique called magnetic seizure therapy (MST) shows~     promise for treating suicidal thinking in chronically depressed individuals. Using a~     high-risk cohort of suicidal patients with borderline personality disorder (BPD) and~     treatment resistant major depressive disorder (MDD), this study will evaluate the~     effectiveness of MST for reducing suicidality and depressive symptoms in an open-label~     clinical trial of up to 15 treatment sessions. Based on research showing that functioning of~     the dorsolateral prefrontal cortex (DLPFC) may be disrupted in BPD and place individuals at~     risk for suicide, the DLPFC will be targeted for stimulation. Moderate-to-highly suicidal~     patients with BPD beginning dialectical behavioural therapy (DBT) will be recruited using a~     case-control design, comparing individuals receiving MST and DBT with matched patient control~     group receiving DBT alone.~   "
15670|NCT03361813|"~     Ultrasound as a technique is safe, readily available, quick and portable allowing more~     accuracy of different regional blocks and local infiltration. It allows imaging of the mouth,~     oropharynx, infrahyoid structures, larynx, vocal cords, and trachea. Recently, ultrasound has~     been shown to improve accuracy in ultrasound guided block with local anesthetic infiltration.~     The objective of our study is to compare the effect of pre-emptive trans-oral ultrasound~     guided peritonsillar infiltration versus trans-cutaneous ultrasound (US) guided peritonsillar~     infiltration with bupivacaine for post-tonsillectomy analgesia, on surgical field, and~     surgeon satisfaction(intra-operative reactionary bleeding).~      Materials and Methods: the patients will be admitted for tonsillectomy at ENT department of~     the Al- Azhar university hospitals. The patients' ages between 3 to 15 years. Patients will~     be divided into Cutaneous group: patients will be submitted to Trans-cutaneous ultrasound~     guided peritonsillar infiltration with bupivacaine, and Oral group: patients will be~     submitted to Trans-oral ultrasound guided peritonsillar infiltration with bupivacaine.~   "
24054|NCT03252119|"~     A randomized control trial of 130 infants admitted to the paediatric high care admission ward~     will be enrolled, and randomized to either high flow humidified oxygen or standard~     therapy.~   "
15671|NCT03361800|"~     This study is investigational and is not designed to treat cancer. In other words, the study~     drug, entinostat, is not being given to treat cancer. Instead, the study team is looking at~     the effects of entinostat on tumor tissue for research purposes only.~      Approximately 246,660 cases of breast cancer were diagnosed in the United States in 2016. Its~     detection and treatment remains a major concern in women's healthcare. In particular, TNBC~     accounts for approximately 15-20% of all breast cancers. Research into treatment for breast~     cancer relies more and more on understanding how the cancer cells act when they are exposed~     to an anti-cancer drug. How most cancer cells act when exposed to anti-cancer drugs and which~     patients as a result may benefit the most from these drugs is not well known. Additional~     studies are required to determine the cells' reactions. The purpose of part 1 of this study~     is to better understand how TNBC tumors react to one particular cancer drug, entinostat.~     Entinostat is currently being studied across multiple clinical trials for the treatment of~     breast cancer, other solid tumors and blood cancers. Entinostat is investigational and has~     not yet been FDA approved for the treatment of cancer.~      Studies have shown that a good way to determine how cancer acts when exposed to anti-cancer~     drugs is a short-term preoperative window study. In this type of study, subjects receive a~     study drug a couple of days before surgery. Leftover tissue from surgery is then used to~     determine some of the effects that a study drug may have on the tumor. In this study,~     subjects will receive two doses of entinostat prior to undergoing planned surgery. Leftover~     tissue from this surgery will then be used to determine the effects entinostat has on tumor~     cells. For example, the study team will examine if the types of genes and proteins that the~     tumor expresses as a result of entinostat exposure increases or decreases the likelihood that~     the tumor will not continue to grow. A gene is a unit of DNA. Genes make up the chemical~     structure carrying your genetic information that may determine human characteristics (i.e.,~     eye color, height and sex). This study will focus on discovering how entinostat affects a~     wide variety of genes in tumor cells.~   "
15672|NCT03361787|"~     The purpose of this pilot study is to examine the initial efficacy of a multi-dimensional~     coaching intervention (Parentship) for parents of adolescents with High Functioning Autism~     (HFASD).~      The Parentship protocol is a short-term intervention program in occupational therapy that~     aims to promote parental resilience and enhance adolescents' participation in daily life.~   "
15673|NCT03361774|"~     The aim of this study is to develop the clinical methodology to characterize the efficacy~     profiles of an experimental 5% potassium nitrate (KNO3) and 0.454% stannous fluoride (SnF2)~     combination dentifrice and a marketed desensitizing 0.454% SnF2 only dentifrice for the~     relief of dentin hypersensitivity (DH), at multiple time points, over an 8 week treatment~     period.~   "
15674|NCT03361761|"~     Through its patient-centered approach and focus on developing coping skills and coping~     strategies, Health Education could be an effective approach in therapeutic coordination~     apartments to reduce the perceived treatment burden among people in precarious situations~     with one or more chronic diseases. Decreasing perception of burden would improve their~     quality of life and adherence to treatment.~      The general hypothesis explored in this project is that the experience of the disease, the~     perception of the burden of treatment, the autonomy and the quality of life of the residents~     improve more importantly in therapeutic coordination apartments having implemented a~     formalized and structured Health Education approach (experimental group) than in those who~     did not set up formalized and structured Health Education approach (control group).~   "
15675|NCT03361748|"~     This is an open label, single-arm, multicenter, Phase 2 study to evaluate the efficacy and~     safety of bb2121 in subjects with relapsed and refractory multiple myeloma. A leukapheresis~     procedure will be performed to manufacture bb2121 chimeric antigen receptor (CAR) modified T~     cells. Prior to bb2121 infusion subjects will receive lymphodepleting therapy with~     fludarabine and cyclophosphamide.~   "
15676|NCT03361735|"~     This phase 2 trial studies radium Ra 223 dichloride, hormone therapy and stereotactic body~     radiation in treating patients with prostate cancer that has spread to other places in the~     body. Radium Ra 223 dichloride contains a radioactive substance that collects in the bone and~     gives off radiation that may kill cancer cells. Hormone therapy using leuprolide acetate or~     goserelin acetate may fight prostate cancer by lowering the amount of testosterone the body~     makes. Stereotactic body radiation therapy is a specialized radiation therapy that sends~     x-rays directly to the tumor using smaller doses over several days and may cause less damage~     to normal tissue. Giving radium Ra 223 dichloride, hormone therapy and stereotactic body~     radiation may work better at treating prostate cancer.~   "
15677|NCT03361722|"~     Vasospasm is a current complication after aneurysmal subarachnoid hemorrhage and often and~     often associated with brain ischemia. This complication is difficult to detect, because~     clinical examination is hardly helpful in sedated patients and the performances of~     transcranial doppler can only detect the spasm of middle cerebral arteries.~      Tissue Oxygen Pressure (PtiO2) Monitoring allows early detection of brain oxygenation local~     modifications and of brain ischemia, via continuous monitoring.~      This study aims to assess the performance of the tissue oxygen pressure monitoring in~     detecting a vasospasm post aneurysmal subarachnoid hemorrhage.~   "
15678|NCT03361709|"~     The prevalence of diabetes mellitus (DM) is rapidly growing worldwide. One major concern with~     diabetes mellitus is how it may affect vision in different ways; including the increased risk~     of developing cataract. Several studies have found an association between diabetes mellitus~     and the development of cataract. In patients with DM, cataract progression is also faster and~     occurs at a younger age.5 While results for modern cataract surgery are satisfactory,~     cataract surgery in diabetic patients carries a higher risk of peri and post-operative~     complications than in non-diabetic patients. Several studies have shown that the corneal~     endothelial count of diabetic patients is decreased, with more damage occurring to corneal~     endothelial cells following phacoemulsification in diabetics than in non-diabetics. This is~     presumed to be due to increased vulnerability of corneal endothelial cells in diabetics and a~     delay in the repair process.~      Administration of topical corticosteroids is the main method to control post-operative~     inflammation after phacoemulsification, however many studies have also proved the safety and~     efficacy of intracameral corticosteroids to control inflammation post-operatively. While~     intracameral triamcinolone is effective in controlling post-operative inflammation, elevation~     of intraocular pressure is a main concern.~      Dexamethasone has been found to be effective in controlling post-operative inflammation with~     no effect on intraocular pressure. This may be due to its rapid turnover and short half-life.~     No studies however have been performed to evaluate the safety and benefit of intracameral~     injection of dexamethasone following phacoemulsification in diabetic patients. In the present~     study, investigators aim to evaluate this and determine its effect on the post-operative~     corneal endothelial cell density and corneal thickness.~   "
15679|NCT03361696|"~     The objective of this project is the realization of tests at home and in Hospitals or~     Functional Rehabilitation for the improvement of the communication with the family and~     medical entourage, the facility of the emotional expression, the evaluation of the pain, the~     control of home automation to increase their autonomy, facilitated their reintegration at~     home. The work is the last step of the research program started in 2009, with the~     optimization of the installation of the system, the improvement of physical and computer~     ergonomic aspects and the development of dedicated interfaces according to the type of~     disability and needs. of each one.~      A work upstream of the definition of specifications taking into account the medical~     constraints was realized and the actions of improvement of the models, the algorithms, the~     robustness and the effectiveness of the treatment are in progress . The specific adaptation~     to concrete cases should lead to a system that allows 90% of the population of people with~     disabilities to exploit the system and significantly improve their level of communication,~     autonomy and in fact their daily lives.~   "
15680|NCT03361683|"~     Patients intubated due to acute respiratory failure have a high risk of infectious~     complications, airway injuries and multiple organic failure, so performing a successful~     extubation from mechanical ventilation is key. Between 10 and 20% of patients develop~     extubation failure, which is related to an increased in-hospital death rate, infections,~     higher costs and longer hospital stays. High-flow nasal oxygen therapy delivers heated,~     humidified air at flows up to 60L/min, and an oxygen concentration close to 100%, providing a~     fresh air reservoir at the naseo-pharyngeal level, evening out the peak inspiratory flow rate~     of the patient, improving air conductance, promoting secretion management, increasing~     end-expiratory lung volume, and applying a positive end-expiratory pressure. Such effects~     result in decreased breathing work, dyspnea relief, improved use tolerance, increased~     oxygenation, and lower fraction of inspired oxygen in patients with hypoxemic respiratory~     failure. High-flow oxygen therapy has recently been described to decrease extubation failure~     in a group of patients classified with low failure risk, in comparison to Venturi mask, and~     it was not inferior to non-invasive mechanical ventilation in high risk patients. However, it~     is worth pointing out that a large percentage of the patients included in such studies did~     not develop acute respiratory failure primarily.~      Given the beneficial effects described above, the investigators hypothesize that high-flow~     nasal oxygen therapy decreases the risk of extubation failure in a group of patients that~     required invasive mechanical ventilation due to acute hypoxemic respiratory failure.~   "
15681|NCT03361670|"~     This is a performance study to test the sensitivity and specificity of the BioFire FilmArray~     Lower Respiratory Tract Infection (LRTI) Panel. The purpose of this study is to prospectively~     collect and test residual Bronchoalveolar lavage (BAL) and sputum specimens and generate~     performance data to support regulatory classification of the FilmArray LRTI as an in vitro~     diagnostic (IVD) in the US, European Union (EU), Canada, and other regions.~   "
15682|NCT03361657|"~     Studying the arterial to end-tidal carbon dioxide difference in children undergoing~     laparoscopic surgeries under different intra-abdominal pressures is of extreme importance.~     This is because both hyper and hypocarbia are detrimental in this vulnerable age group.~   "
15683|NCT03361644|"~     The study will compare the effects of High Intensity Interval Training (HIIT) with Moderate~     Intensity Continuous Training (CMIT) as part of a lifestyle intervention program on BMI~     change in adolescents age 12-16 with obesity.~   "
15684|NCT03361631|"~     Diabetes is a major concern in public health because of its high frequency and its negative~     consequences. Erectile dysfunction (ED) is present, regardless of age, in 50 to 75% of men~     with diabetes. It is related to endothelial dysfunction and a decrease in smooth muscle and~     nerve cells. In type 1 diabetic patients, ED is part of the chronic complications of~     microangiopathy. Current therapies are exclusively symptomatic with moderate efficacy,~     estimated between 44 and 56%. The administration of culture-grown medullary mesenchymal stem~     cells (MSCs) would be a curative treatment and have the advantage of being single injection.~      However, the data in the literature do not allow to define the optimal dose of MSC in this~     indication. In addition, the feasibility of this procedure is not known at present.~      The aim of this study is to evaluate the tolerance and the efficacy of intracavernous~     injection of autologous MSC (bone marrow-derived MSCs) administered in a 4-dose-escalating~     design in patients from 18 to 50 years old with complicated type 1 diabetes mellitus and~     erectile dysfunction.~   "
15685|NCT03361618|"~     Although many reports have investigated the relationship between subfertility and uric acid~     levels in semen, to the best of author knowledge, there is no study have been published to~     yet focus on the effects of asthenospermia treatments, such as given an oral zinc~     supplementation, on the activity of urate-related enzymes, which are important in fertility~     of human.~   "
15686|NCT03361605|"~     This study's purpose is to see if mental functions take place during different levels of~     anesthesia, using a commonly used drug (Propofol). fMRI (functional Magnetic Resonance~     Imaging, or brain imaging) shows areas in the brain involved in thinking at different~     depths of anesthesia.~   "
15687|NCT03361592|"~     Athletes have been exposed to an ever increasing training load and subsequent biomechanical~     overload due to a constant demand for performance enhancement. As a result, it is observed an~     increased rate of musculoskeletal problems, including spinal biomechanical dysfunctions that~     are often asymptomatic. These dysfunctions are believed to negatively influence a wide range~     of mechanical and physiological parameters such as muscle strength, range of motion, and~     symmetry, what could potentially influence sports performance.~      Spinal Manipulative Therapy (SMT) is a safe and effective therapy for musculoskeletal~     disorders that has been increasingly utilized in sports. SMT purpose is to correct spinal~     joints biomechanical dysfunctions using a high-velocity, low-amplitude movement, applied at~     the paraphysiological space, beyond the passive joint range of motion.~      Kinetic and kinematic symmetry can be measured in commonly utilized physical functional tests~     often used as indicators of athlete's performance. Symmetry Index calculation is used to~     verify bilateral asymmetries in static and dynamic tests.~   "
15688|NCT03361579|"~     Open Label Placebo application has been shown to be effective in treatment of chronic pain~     (low back pain) and disease like the irritable bowel Syndrome. Data about effects on acute~     pain are spare.~      The study investigates the effect of an open-label Placebo (substance without a medical~     active component) application on acute pain, evoked via a artificial pain model in healthy~     male volunteers. 32 healthy male volunteers are recruited.~   "
15689|NCT03361566|"~     Aim of the study is to investigate the impact of energy flux (achieved by changes in physical~     activity) under the conditions of energy balance, caloric restriction and overfeeding in~     healthy subjects.~   "
15690|NCT03361553|"~     Current practice guidelines recommend obstructive sleep apnea (OSA) patients to stay in the~     post anesthetic care unit (PACU) until the risk of respiratory depression has subsided.~     Inevitably, a greater demand on hospital resource utilization in these patients will increase~     health care cost. Polysomnography (PSG) and screening questionnaires can identify OSA but~     they are limited by accessibility and false positive results, respectively. Inaccurate OSA~     identification misguides postoperative surveillance plan. In contrast with MRI and CT scans,~     ultrasound is more accessible and more likely a practical tool for OSA screening. However,~     before clinical application, airway ultrasound (US) exam must undergo vigorous testing to~     check its utility, accuracy, inter-observer reliability and its ability to identify OSA and~     its severity.~   "
15696|NCT03361475|"~     SME (Sharing, Mind, Enjoyment) App, A Pilot Project is part of the Community-based Mental~     Wellness Project for Adolescents and Adults, which aims at promoting sharing, mind and~     enjoyment and enhancing mental wellbeing. The Mental Wellness Project is financially~     supported by the Health Care and Promotion Fund from Food and Health Bureau and led by the~     School of Public Health, University of Hong Kong (HKU). This project primarily aims to~     promote the SME related behaviors of adolescents through the App. The evaluation will be~     conducted during the programme implementation stage. The effectiveness of the intervention,~     as well as the level of participation and ratings for the intervention, will be evaluated.~   "
15697|NCT03361462|"~     Joyful Adventure Day - A Pilot Project is part of the Community-based Mental Wellness Project~     for Adolescents and Adults, which aims at promoting Sharing, Mind and Enjoyment (SME) and~     enhancing mental wellbeing. The Mental Wellness Project is financially supported by the~     Health Care and Promotion Fund from Food and Health Bureau and led by the School of Public~     Health, University of Hong Kong (HKU). Joyful Adventure Day - A Pilot Project aims to promote~     the SME related behaviors of adolescents through intervention of physical activities, and to~     promote their happiness, well-being and mental health knowledge.~   "
15698|NCT03361449|"~     The aim of this study is to determine the effect of flamingo exercise on balance in patients~     with balance impairment due to senil osteoarthritis~   "
15699|NCT03361436|"~     This phase Ib trials studies the side effects and best dose of eribulin mesylate when given~     together with radiation therapy in treating patients with retroperitoneal liposarcoma that~     can be removed by surgery. Drugs used in chemotherapy, such as eribulin mesylate, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy~     x-rays to kill tumor cells and shrink tumors. Giving chemotherapy with radiation therapy may~     kill more tumor cells.~   "
15700|NCT03361423|"~     Migraine is a common neurologic with attacks of headache and associated symptoms such as~     nausea, vomiting, phono and photophobia. Migraine can lead to substantial functional~     impairment.~      Recent evidence suggests that electro stimulation is effective in providing relief for~     chronic headaches including migraine. It is tolerable by patients and associated with no~     adverse effects.~      The device utilizes electro stimulation to achieve conditioned pain modulation (CPM). CPM an~     stimulate endogenous analgesic mechanism. The modulatory effect is over the whole body, and~     can be induced anywhere.~      This is a prospective, randomized, double-blind, sham controlled multi-center trial. Ratio~     between treatment and control groups will be 1:1, stratified by center and use of preventive~     medications.~      The study objectives is to demonstrate the safety and effectiveness of the Nerivio Migra~     electro stimulation device for the reduction of migraine headache during an attack of~     migraine with or without aura.~      The study is intended for subject with 2-8 migraine episodes per month. patients will receive~     the device, either an active or a placebo type, and will be asked to use the device at home~     or in any location that they will be when the migraine starts.~      The study hypothesis is that electro stimulation delivered transcutaneously to the peripheral~     nervous system at onset of a migraine attack significantly reduce headache pain demonstrated~     by a significant difference between proportions of responders to the active treatment~     stimulation in comparison to proportion of responders that will use a placebo device.~   "
15701|NCT03361410|"~     Constituents of grapes have been studied for their antioxidant, anti-inflammatory, and~     anticarcinogenic properties. In the past decade, there has been emerging evidence regarding a~     potential role for grapes in slowing cognitive decline and other effects of aging.~     Furthermore, evidence has been obtained in vivo that supplementation with grape seed extract~     in aged rats improves cognitive performance, and that supplementation with grapes in people~     having decline in cognition leads to preservation of metabolism in brain regions important to~     cognitive function over a period of six months. The investigator aims to measure effects of~     grape intake on cerebral metabolism and neuropsychological performance, and to determine~     whether initial patterns, and magnitude of change, of cerebral metabolism assessed by~     positron emission tomography (PET) can serve respectively as a predictor of, and biomarker~     for, the magnitude of cognitive changes resulting from intake of grapes over a period of at~     least one year.~   "
15702|NCT03361397|"~     The primary outcome of this study will be the effect of lidocaine nebulization before LMA~     insertion on LMA insertion score (within 1 minute of LMA insertion) in adult patients~     undergoing surgery under general anesthesia.~      The secondary outcome measures are the effect of LMA insertion on heart rate, arterial blood~     pressure, SpO2, the first time insertion rate of the LMA, and postoperative complications~     during LMA removal (soft tissue trauma, coughing, and laryngospasm).~   "
15703|NCT03361384|"~     The current study is the first empirical investigation that directly addresses the~     correspondence between responses regarding indicators of risky sexual behavior while under~     the influence of alcohol in the laboratory and the occurrence of sexually risky behavior~     while under the influence of alcohol in the natural environment, by use of Ecological~     Sampling Methodology (ESM). The study will allow us to compare and contrast implicit and~     explicit assessments of sexual risk in respect to future behavior in the natural environment.~     The data obtained will thus provide new information regarding the external validity of~     alcohol administration studies of sexual risk behavior and will provide information to~     optimize the selection of dependent measures. The current study also represents the first~     attempt to test a causal model linking alcohol intoxication and risky sexual behavior as a~     function of both automatic, reflexive, approach tendencies and effortful, deliberative,~     self-control (operationalized by executive working memory in this application). The ESM study~     will augment the findings of the experiment by providing a detailed assessment of contextual~     factors that affect sexual risk behavior as well as replicating and extending the findings of~     the experiment to sexual risk situations in the natural environment. Finally, to our~     knowledge there has been only one experimental study of alcohol and sexual risk in MSM~     (Maisto, Palfai, Vanable, Heath, & Woolf-King, 2012), which is remarkable given that MSM have~     been identified as the population at highest risk to contract the HIV in the U.S. since the~     virus was identified in the early 1980s. Thus the proposed research is only the second~     attempt to add to an understanding of the connections among alcohol, cognitive processes, and~     sexual risk behaviors in MSM.~   "
15704|NCT03361371|"~     The sample size calculation is based on the assessment of the between-group difference in~     probability of treatment failure. The estimated total re-visit probability in bronchiolitis~     based on a recently published study was approximately 35% within 72 hours of ED discharge.50~     The investigators can therefore reasonably assume this proportion may approach 50% by day 7.~     Using the 50% estimate is conservative since it requires the largest sample size, providing~     at least 80% power regardless of the observed proportions. This is a superiority study in~     which the adoption of nasal suctioning will be recommended for future practice if the~     observed proportion of the primary outcome in this group is significantly lower than in the~     controls. With 186 patients per arm (372 in total) a two-sided test with a type I error of~     0.05 will have 80% power to achieve statistical significance if suctioning reduces the~     probability of treatment failure from 50% to 35% (i.e. absolute reduction of 15%). This~     estimate is based on clinically relevant differences agreed upon by study investigators and~     it also represents an NNT of 7. In the Cochrane review of asthma therapies an NNT of a~     comparable magnitude led to a change in national practice recommendations.52 Since~     bronchiolitis and related medical visits are highly prevalent,20 this target difference would~     also have an important economic impact. Based on our previous bronchiolitis trials, the~     anticipated refusal rate may be 20%. Given the study design and our past experience, the~     study non-completion rate and loss to follow-up can safely be assumed to be no higher than 5%~     each. Therefore, to have complete data on 372 patients the investigators plan to randomize~     412 (i.e. 372/(1 - 0.05)*(1 - 0.05) and to approach 515 (i.e. 412/(1 - 0.20).~   "
15705|NCT03361358|"~     The purpose of this study is to identify subjects with advanced solid tumors or lymphoma in~     which the methylthioadenosine phosphorylase (MTAP) protein has been lost.~   "
15706|NCT03361345|"~     The goal of this study is to determine if topical tranexamic acid is capable of decreasing~     the pigment of the dark spots left from acne bumps. The first line medication used for this~     often is not tolerated well by patients, and topical tranexamic acid has minimal reported~     side effects thus far.~   "
15707|NCT03361332|"~     The ability to recognize of being the actors of the behaviour and its consequences, the~     so-called Sense of Agency (SoA), is a crucial component of self-awareness. One key aspect~     is the distinction from a mere inference about the causality between an act and its~     consequences and the sense of being the agent of it. Despite a large number of behavioural~     studies, there is unsatisfactory evidence on the functional anatomical underpinnings of the~     SoA and the distinction between causality and the SoA proper. Here, the investigators use an~     implicit measurement of the SoA and its modulations during fMRI: the intentional binding~     phenomenon (IB). The ivestigators also study how the SoA and the ensuing neurophysiological~     correlates are modulated by the presence of a movement disorders, such as Gilles de la~     Tourette Syndrome.~   "
15708|NCT03361319|"~     A PHASE I/II TRIAL OF COMBINATION NAB-PACLITAXEL AND NINTEDANIB OR NAB-PACLITAXEL AND PLACEBO~     IN RELAPSED NSCLC ADENOCARCINOMA~   "
15709|NCT03361306|"~     The study drug elotuzumab, has been clinically shown to be effective in treating~     relapsed/refractory MM in combination with either bortezomib, or lenalidomide and~     dexamethasone. Elotuzumab in combination with lenalidomide and dexamethasone is currently~     approved by the Food and Drug Administration (FDA) for the treatment of patients with~     multiple myeloma. Carfilzomib is also FDA approved for treating multiple myeloma and~     frequently given in combination with lenalidomide and dexamethasone for treatment of~     relapsed/refractory MM. Based on these findings, this study will look at how subjects with~     relapsed/refractory MM respond to a combination treatment with the following drugs:~     elotuzumab, carfilzomib, lenalidomide and dexamethasone. The combination of these four drugs~     is not FDA approved and is experimental.~   "
15710|NCT03361293|"~     This is a randomized placebo-controlled trial of cognitive training with transcranial direct~     current stimulation (tDCS) for children and adolescents (ages 10 - 16 years) with prenatal~     alcohol exposure (PAE).~   "
15711|NCT03361280|"~     Eight maintenance hemodialysis patients are given one of four beta blocker drugs (atenolol,~     bisoprolol, carvedilol, metoprolol) three hours prior to a hemodialysis session. Blood~     samples and spent dialysate are collected during dialysis. On separate dialysis sessions,~     patients received the other study drugs until they have taken each of the four study drugs.~     Dialytic clearance is calculated.~   "
15712|NCT03361267|"~     As the antibiotic resistance increases, the eradication rate of triple therapy is decreasing.~     Recent guideline recommend the use of bismuth-containing quadruple therapy in areas where~     clarithromycin resistance is greater than 15%. However, the ideal treatment would be the~     tailored therapy which choose the antibiotics depending on the antibiotic resistance. This~     study compared the eradication rates, safety and complicance of tailored therapy compared~     with empirical bismuth quadruple therapy in the naive patients with H. pylori infection.~   "
15713|NCT03361254|"~     Extracorporeal photopheresis (ECP) is a worldwide recognized treatment of acute and chronic~     mild to moderate graft versus host disease (GVHD), in second or further line of treatment.~     Contrary to immunosuppressive drugs, ECP is not associated with side effects such as~     opportunistic infections, and is not associated with a higher frequency of relapse of the~     initial hematological disease. High intensity of ECP regimen (1 to 3 sessions per week, in~     case of chronic or acute GVHD) seems to be correlated to a higher efficacy. However, high~     intensity of ECP treatment is often difficult to sustain, because of frequent logistical~     problems to perform aphereses, such as venous access failure, infections of central line,~     deep blood cytopenias that require many transfusions before performing aphereses. Merlin et~     al. first described the feasibility of white blood cells cryopreservation before UVA~     irradiation, in vitro, then in vivo. We also recently reported the feasibility and efficacy~     of cryopreserved ECP in a series of 20 patients (adults and children), with acute and chronic~     GVHD, who had recurrent contraindications to aphereses, that prevented the realization of an~     intensive program of ECP. No adverse events occurred, and efficacy seemed to be similar to~     classical ECP (35% of complete overall response, and 40% of partial response). White blood~     cells (WBC) were divided after collection on Optia or Cellex apheresis machines: one was~     immediately treated with 8-MOP (methoxsalen) and ultraviolet A (UVA) irradiation, while the~     other was cryopreserved, and further (a few days later) thawed, sensitized with 8-MOP and~     irradiated before injection to the patient.~      The aim of this study is to analyze this method in a prospective way, with complete~     biological data collection, of apoptosis, cytokines release etc…, necessary to the full~     description of cryopreservation of white blood cells before their irradiation and reinjection~     to the patient.~      We will propose this technique of cryopreservation to every patient with an indication of ECP~     for acute or chronic GVHD in Nancy Hospital for 18 months.~   "
16059|NCT03356743|"~     This study will analyze spectral features of the radiofrequency of lung tumors in ex-vivo~     human lungs. The resected specimens will be evaluated using the spectrum analysis to~     determine the localization rate of the targets. Ultrasound measurement and images will be~     used for correlation of TS mode image findings with pathology by using HE and IHC slides of~     lung tumor and lymph node.~   "
15714|NCT03361241|"~     The aim of this study is to compare the effects of balance training in a virtual environment~     with and without physiotherapeutic intervention on the motor function, balance and gait in~     chronic stroke patients.~      It is a prospective, single blinded, randomized clinical trial performed at Center of~     Research of the Department of Speech Therapy, Physical Therapy and Occupational Therapy of~     São Paulo University. Forty patients will be randomly assigned in control and experimental~     group.~   "
15715|NCT03361228|"~     The purpose of this study is to assess the safety and antitumor activity of INCB001158 plus~     epacadostat, with or without pembrolizumab, in participants with advanced or metastatic solid~     tumors.~   "
15716|NCT03361215|"~     The clinical study investigates the course of disease in patients with chronic inflammatory~     skin diseases (atopic eczema and psoriasis). For this purpose, patients are asked once a year~     to take part in a data collection, questionnaires on the severity and quality of life are~     filled in and patients are also asked to give blood samples and skin swabs. The skin smears~     are superficial smears of three areas of skin with cotton swabs, which are used to examine~     bacteria on the skin. The blood samples are used to analyze inflammation messengers during~     the course of the disease. Optionally, patients are asked to submit second skin biopsies once~     a year to analyze inflammatory cell-level changes in the skin. Overall, the study will help~     to monitor the pathogenesis of the participating patients for at least ten years and to~     collect information about the inflammatory mechanisms of the diseases. The study has no~     effect on the therapies of the disease, it serves only the accompanying data collection~   "
15717|NCT03361202|"~     The aim of the study is to compare levels of differnts types of microparticles circulating~     before and after percutaneous occluding of the left atrium by patients with atrial~     fibrillation and patients control.~      Hypothesis is that prothesis implantation will decrease levels of microparticles circulating~     in blood circulation because of occluding of the left atrium .~   "
15718|NCT03361189|"~     The closed-loop stimulation (CLS) algorithm is a novel sensor-based technology that relies on~     the change in myocardial systolic impedance for modulation of the heart rate during physical~     and emotional stress.3 The pacing algorithm has been shown to be highly effective for a wide~     range of clinical scenarios. Despite the fact that congenital heart disease (CHD) patients~     are likely to derive significant benefit in terms of functional ability and aerobic capacity~     using this novel technology, the CLS system has not been adequately studied in this~     population. As many CHD patients also undergo epicardial placement of pacing systems at the~     time of concomitant cardiac surgery, CLS has been less often utilized in this population~     given almost no data in the setting of surgical electrode placement. The present study~     intends to examine the benefits of the CLS algorithm in the CHD population, employing the use~     of epicardial pacemaker systems in the study protocol.~   "
15719|NCT03361176|"~     This study is to evaluate the efficacy, edema and pain associated with Kybella(TM) injections~     of the upper neck in the treatment of submental fat with varying low concentrations of~     triamcinolone acetonide plus low doses of lidocaine.~   "
15720|NCT03361163|"~     Group A Streptococcus (GAS) infection is a major cause of death and disability globally with~     a disproportionately high burden in settings of disadvantage worldwide. Acute infections due~     to GAS range from very common superficial skin infections (>150 million prevalent cases) and~     pharyngitis (over 600 million incident cases) to life-threatening invasive disease (>600,000~     incident cases) such as necrotising fasciitis. Post-infectious GAS sequelae of GAS include~     acute rheumatic fever (ARF, ~500,000 incident cases) leading to rheumatic heart disease (RHD,~     ~34 million prevalent cases), and acute glomerulonephritis. The health services impact of GAS~     disease in all its forms is immense and strikes at every level from primary to intensive~     care.~      Controlled human infection models (CHIMs) have a long history of critical contributions to~     vaccine development. Data from CHIMs meeting modern scientific, regulatory, and ethical~     standards, are aiding efforts to control over 25 major human pathogens, including bacteria~     (e.g. pneumococcus, cholera), viruses (e.g. respiratory syncytial virus, influenza), and~     parasites (e.g. malaria, schistosomiasis).~      A reliable and safe controlled human infection model of GAS pharyngitis will be an important~     part of the global vaccine development effort. To build the model, the investigators are~     undertaking a dose-ranging study using an observational, dose-escalation, inpatient trial to~     determine the dose of GAS administered by direct oropharyngeal inoculation (bacteria~     'painted' onto throat) required to reliably produce a pharyngitis attack rate of ≥ 60% in~     carefully screened healthy adult volunteers.~   "
15721|NCT03361150|"~     Surgery is a stressful procedure associate with perioperative physical impairment. In a~     previous study, the investigators showed that physical fitness could be optimize in surgical~     patients using prehabilitation, a preoperative conditioning intervention in form of exercise,~     nutrition and relaxation technique. The best modality of exercise has yet to be known.The~     purpose of this study is to compare high interval (HIT) vs. moderate continuous intensity~     (MC) training, integrated in a prehabilitation intervention in colorectal surgical patients.~   "
15722|NCT03361137|"~     This Phase IV, multicenter study will evaluate whether participants with Hemophilia A and~     inhibitors receiving emicizumab prophylaxis can safely undergo minor surgical procedures~     without prophylactic bypassing agents (BPA).~   "
15723|NCT03361124|"~     Patient's with planned cesarean sections will be randomized to receive either standard 20 mU~     in 1L as a bolus following delivery of the placenta or 20 mu in 1L following delivery of the~     placenta plus an additional 20 mU in 1L over 8 hours.~   "
15724|NCT03361111|"~     Eosinophil infiltration and degranulation in airways has been implicated in the pathology of~     asthma. Periostin is considered to be a marker of eosinophilic inflammation and is one of the~     highly expressed genes in epithelial cells and lung fibroblasts in asthma. Omalizumab is~     approved as add-on therapy in the treatment of severe allergic asthma. The aim of the study~     is to assess inflammatory biomarkers including: blood and sputum eosinophilia, periostin and~     IL-6 as long-term clinical outcomes of omalizumab therapy.~   "
15732|NCT03361007|"~     Transcatheter aortic valve implantation (TAVI) is valuable treatment option for patients, who~     are at the high risk of surgical aortic valve replacement (AVR). Majority of procedures are~     performed through femoral arteries, however in some this access cannot be applied. Common~     carotid artery is one of the alternative routes of delivering the device in those patients.~     Established registry aims at collecting the data prospectively to assess outcomes of TAVI~     through common carotid artery.~   "
15725|NCT03361098|"~     This is a 16 week, phase 4, randomized and placebo controlled trial, investigating the~     separate and combined effects of Sodium Glucose coTransporter 2 (SGLT2) inhibition with~     dapagliflozin and Glucagon Like peptide-1 (GLP-1) receptor agonism with exenatide on food~     intake, body weight and the neural activity in the central satiety and reward circuits in~     response to food-related stimuli by blood oxygen level-dependent (BOLD) fMRI in obese type 2~     diabetes patients. The investigators hypothesize that treatment with SGLT2 inhibitors is~     associated with alterations in central reward and satiety circuits in response to food~     related stimuli, leading to increased appetite and food intake. In addition, the~     investigators hypothesize that adding a GLP-1 receptor agonist to the treatment with an SGLT2~     inhibitor may increase weight loss and prevent the increased food intake during treatment~     with SGLT2 inhibitors due to effects on neuronal activity of central satiety and reward~     circuits in response to food-related stimuli in obese patients with T2DM.~   "
15726|NCT03361085|"~     This project aims to design, implement and evaluate a modular bundle of prevention measures~     for non-ventilator-associated hospital-acquired pneumonia (nvHAP). It is a single-center~     project, taking place at the University Hospital in Zurich (UHZ). For effectivity reasons,~     only departments and their related wards with a substantial nvHAP rate (nvHAP/patient~     discharge or death) will be included. Intermediate care wards (IMC) will be included,~     intensive care units (ICU) will be excluded.~      The five work packages (WP) are:~        1. Design bundle of prevention measures for nvHAP - The nvHAP-bundle~        2. Implementation of nvHAP-bundle~        3. Evaluation of nvHAP-bundle concerning effectiveness to prevent nvHAP~        4. Evaluation of adherence to nvHAP-Bundle elements~        5. Evaluation of implementation strategy, i.e. satisfaction, protocol fidelity, and~          sustainability~      For this project, the investigators work with the theoretical conception that interventions~     are composed of 'core components' (the central and crucial elements of the intervention) and~     an 'adaptable periphery' (the features of the intervention that can be adapted to the~     specific context to which it is being implemented). During WP1 of this project, the~     investigators will work together with experts to establish the core technical components of~     the nvHAP-Bundle. In WP2, the investigators will collaborate with frontline providers during~     a series of Implementation learning laboratories, and support them in developing unique~     implementation plans adapted to their local contexts, representing the adaptable periphery of~     the intervention. The five dimensions of the Consolidation framework for implementation~     Research (CFIR) framework will serve as a theoretical guide to describe the implementation~     strategy. Implementation will happen according to the principals of change management~   "
15727|NCT03361072|"~     The aim is to analyse the results of per oral immunotherapy treatment in severe milk, peanut~     or egg allergy in adults. This is the second part of the oral immunotherapy study in adults~     at Skin and Allergy Hospital. The diagnosis of food allergy is verified with positive~     history, skin prick tests, egg and milk allergen specific IgE (immunoglobulin E) antibodies.~     In addition, food allergy is verified with an open label (milk allergy) or blind (peanut and~     egg allergy) allergen specific challenge test. OIT (oral immunotherapy) is performed~     according to a detailed plan. Lung function parameters are followed before OIT and and a year~     after OIT.~   "
15728|NCT03361059|"~     Introduction: the prevalence of falls in adults aged 65 years or older living in the~     community is 30%, being the second cause of accidental fatal injury and the fifth cause of~     death. About 20 to 30% of falls result in injuries: 10% constitute serious injuries, from~     which 5% are fractures. As a result, older adults decrease their mobility, are afraid of~     falling depressed and socially isolated, increasing the risk of later falls, death and health~     costs. Falls and their consequences can be prevented, so knowing and assessing the~     demographic, medical, self-perceived and functional characteristics constitutes an important~     information for health professionals. Given the high rate (29.59%) of older adults treated at~     the Physical Therapy outpatient consult of the Hospital Francisco Santojanni and the~     relevance of falls in this population, it is convenient to take a behavior and start by~     knowing their risk characteristics.~      Objectives: to determine the incidence of falls of adults aged 65 years and older, seen in~     the Physical Therapy outpatient consult of the Hospital Francisco Santojanni; to describe~     the characteristics of these population and to identify the potential risk-of-falling~     factors.~      Subjects and Methods: observational, prospective, longitudinal cohort study. Demographic (age~     and sex), medical (history of falls, visual alterations, medication and walking aids),~     self-perceived (fear of falling and instability perception) and functional characteristics~     (Test of Timed up and Go, Dynamic Index of gait and balance tests) will be evaluated in those~     patients of 65 years or more who initiate physical treatment in the outpatient consult of the~     of the Hospital Francisco Santojanni Autonomous City of Buenos Aires, from March 2017 to~     February 2018, with a follow-up of 6 months until August 2018, to verify the development of~     the fall event~   "
15729|NCT03361046|"~     In the past years a substantial shift away from mechanical heart valves occurred and~     bioprosthetic heart valves claimed majority of market shares irrespective of patients'~     age.This indicates that population with failed surgical bioprostheses requiring ViV-TAVI will~     grow significantly and therefore, meticulous prospective data collection is necessary for~     future analyses in order to better understand potential limitations of this procedure.~   "
15730|NCT03361033|"~     Children with brain tumors are at risk for a number of psychological late effects, including~     neurocognitive and social deficits. This observational study focuses on assessment of social~     functioning, including social-cognitive and neurocognitive abilities, in survivors of~     pediatric brain tumors. This study will also assess the influence of medical factors,~     including diagnosis and age at diagnosis, on social functioning.~      PRIMARY OBJECTIVE: Examine the impact of social-cognitive and neurocognitive abilities on~     social functioning in survivors of pediatric brain tumors.~      SECONDARY OBJECTIVE: Assess the influence of medical factors such as diagnosis and age at~     diagnosis on the social functioning of survivors of pediatric brain tumors.~   "
15731|NCT03361020|"~     While thoracic radiation therapy (TRT) has been a primary component in successful treatment~     of Hodgkin lymphoma, exposure to this treatment has been associated with significant~     cardiovascular, cerebrovascular, and pulmonary morbidity in long-term survivors. Survivors of~     Hodgkin lymphoma (HL) are also at risk for fatigue and excessive daytime sleepiness.~     Insufficient sleep is recognized as an important public health concern, and is associated~     with cardiovascular disease, diabetes, obesity, neurocognitive problems, and reduced quality~     of life and productivity.~      Survivors of HL, who are already at risk for cardiac and neurologic morbidity due to their~     treatment exposures, could face catastrophic cardiovascular and cerebrovascular events with~     the added risk associated with obstructive sleep apnea (OSA). The investigators propose to~     examine indices of sleep quality using polysomnography, and associated neurocognitive~     performance, brain MRI, and structure and strength of neck muscles in 220 long-term adult~     survivors of Hodgkin lymphoma treated with thoracic radiation.~      OBJECTIVES:~        1. To estimate the prevalence of OSA in adult survivors of HL treated with thoracic~          radiation, and compare the frequency to community controls matched on age, gender, race~          and body mass index.~        2. To identify specific therapeutic factors associated with OSA in adult survivors of HL~          treated with thoracic radiation.~        3. To identify biomarkers of OSA in adult survivors of HL treated with thoracic radiation.~        4. To examine associations between OSA and cardiac morbidity and brain integrity in the~          adult survivors of HL treated with thoracic radiation.~   "
18332|NCT03326973|"~     To identify and describe long-term quality of life (QOL) issues in patients with metastatic~     melanoma treated with checkpoint inhibitors who achieved cancer control for a minimum of 12~     months and remain on maintenance checkpoint inhibitor therapy.~   "
15733|NCT03360994|"~     Princess Margaret's Multidisciplinary Testicular Cancer (TCa) Clinic sees over 25% of~     Ontario's testicular cancer patients, many of whom travel long distances. Fortunately, the~     majority of cases are confined to the testicle and are managed by active surveillance (AS),~     whereby blood work and imaging at regular intervals look to detect relapse at a curable~     stage. This currently requires multiple clinic visits over 5-9 years. This follow-up can be~     time-consuming, costly, difficult to adhere to and unsatisfying for patients. The goal of~     this project is to develop an efficient technological platform to perform virtual cancer~     follow-up. The platform has been named, WATChmAN which stands for Web-based virtual~     Testicular CANcer clinic. It will provide a secure, online interface to all virtual follow-up~     visits as an alternative to costly and time-consuming travel for in-person visits. The~     investigators anticipate improved patient satisfaction and dramatic reductions in the cost of~     cancer care follow-up. Moreover, the investigators anticipate improved compliance, which will~     lead to safer care. While TCa serves as the working platform, the investigators envision the~     end-product to be scalable and generalizable to other cancers (e.g. prostate cancer~     surveillance) across the province.~   "
15734|NCT03360981|"~     Cardiovascular disease (CVD) is a group of diseases including both the heart and blood~     vessels, thereby including coronary heart disease (CHD). To date, diabetics have a higher~     incidence and prevalence of multivessels CHD. Treatments in multivessels CHD in diabetics~     include full medical anti ischemic therapy, and revascularization therapy (Percutaneous~     coronary intervention (PCI) and/or Coronary artery bypass grafting (CABG)). Randomized trials~     comparing multivessel PCI to CABG have consistently demonstrated the superiority of CABG in~     reducing mortality, myocardial infarctions and need for repeat revascularizations. After the~     CABG treatment, diabetics vs. non-diabetics evidenced a worse prognosis, and an increased~     mortality. Numerous molecular, epigenetics (as microRNAs), and other metabolic risk factors~     may condition the worse prognosis in diabetics vs. non diabetics after CABG. In this context,~     an increased epicardial fat tissue thickness may be independently associated with the~     prevalence of diabetes, and diabetics have an higher epicardial fat tissue thickness,~     volumetry, and enhanced metabolism. Therefore, after CABG, lifestyle and medical improvements~     may lead to the reduction of epicardial fat thickness, extension, and metabolism in both~     non-diabetics, and diabetics, ameliorating the prognosis. At moment, epicardial tissue~     function in diabetics is not well investigated in literature, and no data has been reported~     about new hypoglycemic drugs, and its pleiotropic effects on diabetics after CABG. Indeed,~     our study hypothesis was that, epicardial fat tissue dimension, and metabolic activity may be~     related to a different expression of inflammatory, oxidative, and apoptotics molecules, and~     epigenetic effectors in diabetics vs. non-diabetics. Secondary, these effectors, and~     epicardial tissue dimension and activity, may be controlled, after CABG, by incretin~     treatment in diabetics. Therefore, incretin therapy may be associated to the reduction in~     epicardial fat tissue thickness, and extension, with down regulation of different~     inflammatory, oxidative and apoptotics molecules, and epigenetic effectors involved in~     epicardial fat metabolism. Moreover, in this study authors will evaluate in diabetics vs. non~     diabetics, and in diabetic incretin-users vs. never.-incretin-users, all cause mortality,~     cardiac mortality, and Major adverse cardiac events (MACE) after CABG in diabetics vs. non~     diabetics, and diabetic incretin-users (6 months of incretin therapy) vs. diabetic~     never-incretin-users. Authors will correlate these clinical endpoints to the study of the~     epicardial fat anatomy and metabolism before and after CABG, and to circulating inflammatory~     and pro-apoptotic markers, epigenetic effectors, and stem cells in diabetics vs. non~     diabetics, and diabetic incretin-users (6 months of incretin therapy) vs. diabetic~     never-incretin-users.~   "
15735|NCT03360968|"~     Rationale Studies show that about a third of all postoperative complications are due to~     cardiovascular reasons. Furthermore it was shown that more than 50% of postoperative deaths~     are associated with severe cardiovascular incidents. After surgical interventions seriously~     ill patients are transferred to intensive care units and mechanically ventilated. However~     there is not much evidence about the impact of mechanical ventilation on the cardiovascular~     system and cardiovascular complications. Artificial mechanical ventilation greatly differs~     from physiological breathing. In contrast to physiological negative pressure ventilation of~     th lung, mechanical positive pressure ventilation can cause ventilator induced lung injuries.~     Furthermore a significant deterioration of lung-heart-interaction during mechanical~     ventilation is known.~      Relevance Mechanical ventilation leads to a decreased heartrate-variability, which has to be~     understood as increased stress on the cardiovascular system. Recently, a new ventilation mode~     called variable pressure support ventilation (VPSV) also known as noisy pressure support~     ventilation. This new ventilation mode is similar to the ventilator mode~     spontaneous-continuous positive airway pressure/pressure support (SPN-CPAP), which is often~     used in a intensive care unit routine. Though VPSV differs through varying applicated~     pressure support and therefore tidal volumes. Therefore the new ventilation mode rather~     imitates physiological situation, since tidal volumes vary in physiological breathing, which~     has positive impact on heart-lung-interaction.~   "
15736|NCT03360955|"~     This study compares the extubation time between total intravenous anesthesia guided by~     Bispectral Index with spinal anesthesia with minimal opioid dose for cardiac surgery.~   "
15737|NCT03360942|"~     The long term follow up of a pilot study in which the invesitagors proposed to test whether~     high frequency stimulation of the subcallosal cingulate (SCC) is a safe and efficacious~     antidepressant treatment in five TRD patients, to compare the effects of left-sided vs.~     right-sided stimulation, and to investigate potential mechanisms of action of this~     intervention. Importantly, this study will be used to assess the need for and assist in~     planning a larger, more definitive trial of SCC DBS for TRD.~   "
15738|NCT03360929|"~     This is a multi-center, open-label, dose escalation and phase I/II study, consisting of dose~     escalation in Part A and extension in Part B.~   "
15739|NCT03360916|"~     The purpose of this study is to determine how different doses of a statin affect muscle~     health and exercise.~   "
15740|NCT03360903|"~     At present clinicians have no way to reverse anesthesia. Patients wake when their bodies~     clear the anesthetic. Most people wake quickly, but some do not. All patients have memory and~     other cognitive problems after waking from anesthesia. In studies on animals, the~     investigators observed that caffeine caused rats to wake much more rapidly from propofol~     anesthesia. This was true for all the animals tested. The investigators would like to see if~     this holds true in humans. Will caffeine accelerate waking from anesthesia? Will it reverse~     the cognitive deficits associated with anesthesia, after waking?~      The propose investigators carrying out a modest trial with 8 test subjects. Each volunteer~     will be anesthetized twice. Each volunteer will be anesthetized one time and receive an~     infusion of saline (placebo control), without the aid of any other drugs and the other time~     the volunteer will receive an infusion of a relatively low dose of caffeine. The order of~     saline versus caffeine will be randomized and the study will be done in a double blind~     manner. We will determine whether emergence from propofol anesthesia will be significantly~     accelerated by the caffeine infusion. And whether any adverse events are observed.~   "
15741|NCT03360890|"~     Phase II, 2-cohort, single arm trial treated with the combination of the following two~     agents:~        1. Pembrolizumab (MK3475) 200mg, every three weeks, iv~        2. Docetaxel 75mg/m2, every three weeks, iv~   "
16060|NCT03356730|"~     1. Title~        2. Executive team~        3. Research line~        4. Summary~        5. Research problem~        6. Justification~        7. Literature review~        8. Objectives~        9. Materials and methods~       10. Dissemination of knowledge generated~       11. Schedule of activities~       12. Budget~       13. References~       14. Annexes~   "
15742|NCT03360877|"~     While the standardization of treatment protocols for Severe Acute Malnutrition (SAM) has~     helped to reduce historically high mortality, mortality in inpatient settings remains~     substantial, likely due to the severity of complications associated with late presentation~     and health-care associated infection (HCAI).~      The purpose of this study is to serve as an important stand-alone description to inform the~     understanding of the magnitude of the problem and help guide implementation of measures to~     reduce the risk of nosocomial infection and multi-drug resistance.~   "
15743|NCT03360864|"~     To describe, with a patient reported score (BIOSECURE), the influence of an approved~     therapeutic education program (TEP) in patients with joint inflammation requiring a~     biological treatment initiation.~      The hypothesis is that patients attending the TEP will display better cognitive and~     adaptation competences than patients with no TEP.~      Patient's reported quality of life, disease related stress management, treatment adherence,~     socio-demographic factors, biological home administration modalities and if the biologic~     treatment is maintained at 12 months, will also be described.~   "
15744|NCT03360851|"~     Rationale:~      Uncertainty in the clinical and etiological diagnosis of community-acquired pneumonia (CAP)~     often leads to incorrect treatment and unnecessary use of broad-spectrum antibiotics.~     Establishing the clinical diagnosis of CAP is hampered by the suboptimal sensitivity of chest~     radiograph to detect pulmonary infiltrates (~70%). Establishing the etiological diagnosis is~     also hampered, mainly because of the inevitable diagnostic delays and low sensitivity of~     routine microbiological tests. There are currently no recommendations for low-dose chest~     computed tomography (low-dose CT) or viral and bacterial point-of-care multiplex polymerase~     chain reaction (PoC-PCR) in the diagnostic work-up of CAP patients, because the data~     supporting such an approach are lacking.~      Objective: The aim of this study is to determine the added value of low-dose CT and PoC-PCR~     in the diagnostic workup of patients with CAP hospitalised to non-intensive care unit (ICU)~     wards in minimizing selective antibiotic pressure while maintaining patient safety.~      Study design: Cluster-randomised controlled trial with historical control period.~      Study population: Adult patients (>=18 years old) with a clinical diagnosis of CAP requiring~     hospitalisation to a non-ICU ward.~      Intervention: Intervention arm 1: availability of PoC-PCR during the ER visit; intervention~     arm 2: performing low-dose CT from the ER or at least within 24 hours; control arm: standard~     care.~      Main study parameters/endpoints: The primary effectiveness outcome is days of therapy of~     broad-spectrum antibiotics. The primary safety outcome, on which the sample size is~     calculated, is 90-day all-cause mortality.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: There are no risks associated with performing the PoC-PCR and the radiation of~     the low-dose CT is of negligible risk. Nasopharyngeal swab collection causes a temporary~     unpleasant sensation. The low-dose CT can reveal unexpected findings which may require~     additional diagnostic procedures, for which the treating physician will use state-of-the-art~     guidelines. Treatment recommendations to de-escalate or stop antibiotic treatment may be~     beneficial for the individual patient by minimising exposure to antibiotics and improve~     targeted use of antibiotics. Final decisions are always made by the treating physician taking~     into account all clinical information.~   "
15745|NCT03360838|"~     This observational cohort study is designed to validate the CogCheck application as a risk~     prediction tool for postoperative delirium in patients undergoing cardiac surgery.~   "
15746|NCT03360825|"~     The primary aim of this clinical investigation is to examine a prototype of a quantitative~     monitoring instrument that will meet most, if not all, of the clinical requirements.~   "
15747|NCT03360812|"~     This study evaluates whether an online training resource can improve the performance of~     medical students in recognising imminently dying palliative care patients.~   "
15748|NCT03360799|"~     The goal of this research study is to learn about and compare the attitudes that patients in~     non-legalized and legalized states have towards the legalization of medical marijuana.~      This is an investigational study.~      Up to 200 participants will be enrolled in this study. Up to 100 will take part at MD~     Anderson.~   "
15749|NCT03360786|"~     1. Background and Rationale:~           Little is currently known about intrinsic risk factors for sport-related concussion in~          youth ice hockey players. Emerging research suggests that alterations in cervical and~          balance function increase the risk of concussion in youth ice hockey players. Thus,~          evaluation of a primary prevention program aimed at addressing alterations in cervical~          and vestibular function may result in a protective effect in reducing the risk of~          concussion. Such a program targeting intrinsic risk factors for concussion has not~          previously been evaluated and thus a pilot Randomized control trial (RCT) to inform the~          feasibility and efficacy of such a program is needed prior to proceeding to evaluation~          of such a program on a larger scale.~        2. Research Question and Objectives~           The primary objectives of this pilot RCT study are: 1) To evaluate the feasibility of a~          concussion prevention program in youth ice hockey players; and 2) To evaluate the~          efficacy of a concussion prevention program in decreasing the risk of concussion.~          Exploratory objectives include evaluating the changes in quality of life, clinical~          measures of cervical and vestibular function measures and Hockey Canada on-ice skills~          testing in youth ice hockey players following a concussion prevention program.~        3. Methods~      This study will be a pilot RCT. Prior to the 2017 hockey season, 120 players from 8 youth ice~     hockey teams ages 13-17 will be recruited to participate. Once parental consent and/or player~     assent has been obtained, players will complete a series of initial intake forms. Baseline~     tests and measures, including a standardized preseason baseline questionnaire (regarding~     playing history, past medical history, participation in sport) and a battery of~     questionnaires and clinical measures. Individuals will be randomly allocated into either a~     control protocol (general cardiovascular warm-up, general stretching and strengthening,~     education on concussion identification) or a specific protocol (balance, neuromotor control,~     strength, vestibulo-ocular and oculomotor training + concussion education). Both groups will~     meet with the study physiotherapist once weekly for 4 weeks and exercises will be progressed.~     A previously validated prospective injury surveillance system will be implemented. As part of~     this process, a team designate will collect data throughout the season regarding individual~     player participation in games, practices and dry land training sessions. Individuals with a~     suspected concussion will be referred to the study sport medicine physician for evaluation,~     diagnosis and standard of care management. At this time all baseline tests and measures will~     be repeated.~   "
15750|NCT03360773|"~     The aim of this study is to analyze both depressive symptomatology and psychological~     well-being fluctuation in a day-to-day basis in the general population, in order to identify~     contextual determinants of the mood and well-being changes~   "
15751|NCT03360760|"~     To study the effect of the timing of surgery on outcome of patients with nonmetastatic~     osteosarcoma of pelvis and sacrum.~   "
15752|NCT03360747|"~     This is a single center, open-label study to evaluate the efficacy of AKCEA-ANGPTL3-LRX for~     reduction of triglyceride (TG) levels in patients with Familial Chylomicronemia Syndrome~     (FCS) .~   "
15753|NCT03360734|"~     This is a single arm phase Ib study. The purpose of this study is to evaluate the safety and~     efficacy of a combined therapy with Tomuzotuximab and Gatipotuzumab in patients with solid~     tumors expressing EGFR, for whom no standard treatment is available.~   "
15754|NCT03360721|"~     The goal of this clinical research study is to learn if apalutamide in combination with~     abiraterone acetate and prednisone can help to control metastatic (has spread)~     castration-resistant prostate cancer (mCRPC) that has a certain type of biomarker in the~     tumor. Biomarkers are found in the blood/tissue and may be related to your reaction to the~     study drug(s).~      This is an investigational study. Apalutamide is not FDA approved or commercially available.~     It is currently being used for research purposes. The combination of abiraterone acetate and~     prednisone is FDA approved and commercially available for the treatment of mCRPC.~      The study doctor can explain how the study drugs are designed to work.~      Up to 60 participants will be enrolled in this study. All will take part at MD Anderson.~   "
16074|NCT03356548|"~     Observational study.~   "
15755|NCT03360708|"~     This pilot early phase I trial studies the side effects of vaccine therapy and~     cytokine-induced killer cells in treating patients with glioblastoma that has come back.~     Vaccines made from a person's white blood cells mixed with tumor proteins from another~     person's glioblastoma tumors may help the body build an effective immune response to kill~     tumor cells. Cytokine-induced killer cells are white blood cells with a powerful ability to~     kill tumor cells without any further modification. Giving vaccine therapy and~     cytokine-induced killer cells may work better in treating patients with glioblastoma.~   "
15756|NCT03360695|"~     The purpose of this research is to understand if it is helpful for patients with mental~     illness to be connected to a psychiatrist and case manager at the time of cancer diagnosis.~   "
15757|NCT03360682|"~     The aims of this study are to obtain pharmacokinetic data on interactions between~     dolutegravir (DTG) and immunosuppressant drugs (Cyclosporine A, Tacrolimus, Sirolimus and~     Mycophenolic acid) in solid organ transplant (SOT) recipients to provide proof of principle~     data that DTG plus 2 nucleosides (NUCs) is safe and effective in HIV-infected SOT recipients.~   "
15758|NCT03360669|"~     Automated office blood pressure (AOBP) devices are recommended for high blood pressure~     diagnosis. One of those devices is the Omron HEM-907 (Omron Healthcare). It is currently not~     known if blood pressure measurements performed with this device in a clinical setting are~     equivalent to those made in a research setting. Therefore, this randomized-controlled trial~     was designed. It aims to compare the blood pressure measurements performed in a clinical and~     a research setting. Seventy patients will be included and randomized to a clinical/research~     or research/clinical sequence.~   "
15759|NCT03360656|"~     The objective of this study is to evaluate safety and performance of the COOLSTAT® Transnasal~     Thermal Regulating Device in reducing temperature in a population of febrile subjects who~     meet the inclusion/exclusion criteria.~   "
15760|NCT03360643|"~     Pediatric emergency medicine (PEM) physicians are increasingly utilizing point-of-care~     ultrasound (POCUS). There is currently limited data regarding POCUS evaluation for~     intussusception in pediatric patients. To better understand the role of POCUS for~     identification of intussusception, the investigators plan to conduct a randomized,~     noninferiority study comparing POCUS and radiology-performed ultrasound (RADUS), utilizing~     experienced sonographers across multiple institutions.~   "
15761|NCT03360630|"~     A randomized controlled study to compared the clinical effects and safety of immunotherapy~     with dendritic cells and cytokine-induced killer cells administered with anti-PD-1 antibody~     in advanced NSCLC.~   "
15762|NCT03360617|"~     This study compares whether or not a safety difference exists between delivering antibiotics~     via IV push or IV piggyback method.~   "
15763|NCT03360604|"~     The current study aims to investigate the effects of two GI diets (low vs. high GI) in a~     sample (24 participants) that has diet controlled type 2 diabetes. This sample has been~     chosen as those with diabetes have been shown to suffer with poor glucose tolerance, along~     with the associated deficits such as compromised cognitive function. Therefore, it is~     expected that differences produced by the two diets on blood glucose concentrations and~     cognitive performance will be greater than those previously seen. If this is the case after~     analyzing the results, it will provide a potential strategy (diet) for improving glucose~     tolerance and cognitive performance in a vulnerable section of the population.~   "
15764|NCT03360591|"~     The aim of this study is to compare the clinical outcome of patients with severe aortic valve~     stenosis and associated significant coronary artery disease treated with TAVI and a~     percutaneous myocardial revascularization dictated according to two different strategies:~        1. the Angiographically-guided strategy;~        2. the Physiologically-guided strategy.~   "
15765|NCT03360578|"~     Participants will be asked to wear a physiological monitoring device for 1 week and record~     when panic events occur. Once the device is returned, the data will be downloaded and~     analyzed.~   "
15766|NCT03360565|"~     This clinical trial is a monocentric, prospective, observational and controlled trial~     (historical cohort control group of healthy non-obese subjects who had Nasal functional~     exploration for Snoring) as part of current care.~      This study concerns the prevalence of obstructive sleep apnea syndrome (OSAS). OSAS is~     elevated in subjects with morbid obesity (BMI≥40) (on average 70%). International~     recommendations agree on the need to seek OSAS before bariatric surgery because of the high~     risk of complications.~      Increased nasal resistance could also be related to a limitation of inspiratory flow due to~     an abnormality of the elasticity of the nasal mucosa or nasal compliance. Adipose~     infiltration of the nasal mucosa may occur during obesity.~      These tissue changes (decreased vaso-erectile tissue and increased adipose tissue) could~     modify the nasal compliance, which the decrease would be a possible factor of severity of~     OSAS in obese patients. Screening for an abnormality of compliance could also anticipate a~     difficulty of equipment for Continuous Positive Airway Pressure (CPAP) in the case of~     associated OSAS.~      All patients who must have bariatric surgery and get in the criteria are included. They will~     have to do a medical checkup pre and post-operative (polygraphy + ear/nose/throat assessment~     (ENT) + Nasal functional exploration). They will be followed for 13 to 24 months.~      The main objective of this research is to demonstrate a reduction of at least 30% of nasal~     compliance in a group of obese subjects (BMI> 35) compared to a control group of healthy~     subjects.~      The secondary objectives are to is to demonstrate an increase of 30% in resistance in~     patients with BMI> 35 compared to control group and a normalization of nasal compliance 1~     year after surgery when their weight is normalized (BMI <30).~      A study period of 4 years is planned.~   "
15767|NCT03360552|"~     The objective of the present study is to evaluate the effectiveness of a general practitioner~     (MG) management strategy guided by a multidimensional evaluation on the multidimensional~     score of fragility of patients with mild to moderately severe dementia, compared to those~     currently implemented (without the provision of such an assessment). The measurement of the~     respective effectiveness of the two types of care in primary care will itself be based on a~     multidimensional evaluation performed independently in the memory center having established~     the diagnosis of Alzheimer's disease. The secondary objectives are the evaluation of the~     impact of the strategy on the functional abilities of patients, the incidence of geriatric~     syndromes, cognitive functions, quality of life of the patient and the burden of the primary~     caregiver. The efficiency of the strategy will be assessed through a cost-effectiveness~     analysis. A survey of opinions will also be conducted among primary health care providers,~     carers and CMs on the implemented system.~   "
15805|NCT03360045|"~     Aim of this study is evaluate whether superior nasal compression with tranexamic acid to~     simple nasal compression and Merocel packing.~      In this study, patients who presented with non-traumatic anterior epistaxis to emergency~     departments will be included in this study. Three different therapy option are created;~     first, nasal compression with tranexamic acid, second, simple nasal compression without any~     drugs. And third, packing with Merocel.~   "
15768|NCT03360539|"~     This study evaluates the effects of the Nurse Family Partnership (NFP), an established~     home-visiting program, using a scientifically rigorous individual-level randomized controlled~     trial. The study will be based in South Carolina, where a Medicaid waiver in combination with~     a pay-for-success contract will allow expansion of the program to women on Medicaid. The~     study plans to enroll 4000 low-income, first time mothers and their children into the~     intervention group, and another 2000 into the control group. The study will evaluate the~     program's impacts on outcomes using administrative records. This study aims to yield new~     evidence on the effect of NFP in a modern context, applied to a new population, across a~     broad range of outcomes, and financed by a novel public-private partnership based on~     accountability for outcomes.~   "
15769|NCT03360526|"~     Does the level of statistic oxidation reduction potential (sORP) affects the choice of sperm~     source or sperm selection method used during ICSI.~   "
15770|NCT03360513|"~     This study aims to determine the shape and dimension of dental arches from a lingual~     perspective, and determine shape and size used for lingual Orthodontics.~   "
15771|NCT03360500|"~     The purpose of this study is to verify the effect of cryotherapy associated with an exercise~     protocol in pain control, function and quality of life in individuals with knee~     osteoarthritis~   "
15772|NCT03360487|"~     Background: Multiple sclerosis (MS) is an autoimmune disease, for which the forms of~     treatment are medication and rehabilitation. However, in vitro and in vivo studies have~     demonstrated that photobiomodulation can be an effective treatment modality for inflammatory~     diseases, including MS. Photobiomodulation has a broad range of benefits, such as the~     avoidance of cell and tissue death, the stimulation of healing and injury repair, reductions~     in pain, edema and inflammation, cell proliferation and even apoptosis. The outcomes of~     photobiomodulation include the regeneration of cells, the stimulation of the growth of~     Schwann cells, a reduction in spasticity, functional improvements, a reduction in nitric~     oxide levels and the upregulation of the cytokine IL10, demonstrating that this therapeutic~     modality can offer neuro-protection.~      Methods: A randomized, controlled, double-blind, clinical trial is proposed. The patients~     will be divided into six groups. Groups 1 and 2 will receive sham and active~     photobiomodulation in the sublingual region, respectively. Groups 3 and 4 will receive sham~     and active photobiomodulation along the spinal cord, respectively. Group 5 will receive~     placebo treatment with photobiomodulation on the skin in the region of the radial artery with~     a specific bracelet. Group 6 will be treated with photobiomodulation on the skin in the~     region of the radial artery with a specific bracelet.~      Discussion: Treatment for MS is directed at the immune response and slowing the progression~     of the disease. This is one of the first clinical trials with sublingual and along the spinal~     cord photobiomodulation, which could help establish a new, promising treatment of the disease~     associated with pharmacological treatment.~   "
15773|NCT03360474|"~     The purpose of this project is to improve patient outcomes in individuals affected by cancer,~     through the implementation of a delirium screening and treatment protocol in the ICU setting.~     The hypothesis is that patients who receive an accurate and early diagnosis of delirium~     coupled with a standardized intervention protocol will demonstrate improved patient outcomes~     as evidenced by fewer days spent in the ICU, fewer days spent in the hospital (overall length~     of stay) and the need for less sedative medication throughout their ICU stay as compared to~     patient data prior to the implementation of a delirium protocol.~   "
15774|NCT03360461|"~     EMI-137 in laparoscopic colonic resections is a single-centre stage IIa developmental study.~      Ten adult participants with a diagnosis of colon adenocarcinoma undergoing laparoscopic~     colonic will be recruited to the trial. Participants will receive a single intravenous dose~     of the IMP - EMI-137 1 to 3 hours before surgery. The ability of EMI-137 to produce visible~     intra-operative fluorescence of primary colon cancer and lymph node metastases will be~     explored and evaluated.~   "
15775|NCT03360448|"~     To determine the safety and efficacy of an intracoronary injection of adenovirus 5 encoding~     human adenylyl cyclase 6 (RT-100) in patients with heart failure with reduced left~     ventricular ejection fraction (HFrEF) in a Phase 3 clinical trial.~   "
15776|NCT03360435|"~     Patients undergoing bariatric surgery often develop new vitamin and/or mineral deficiencies~     or exacerbate prior deficiencies after surgery. Several bariatric supplement products exist~     including oral tablets and transdermal patches. The purpose of this study is to observe the~     concentrations of serum micronutrients and determine how many deficiencies develop in~     patients who use a transdermal patch.~   "
15777|NCT03360422|"~     According to the National HIV/AIDS Strategy, men who have sex with men (MSM), young adults,~     Black and Latino men and people in the Southern U.S. are at highest HIV risk and should be~     targeted with cost-effective, scalable interventions. The study team propose a synergistic~     mobile intervention to reduce alcohol and HIV risk in young adult MSM that combines 3~     efficacious approaches.~   "
15778|NCT03360409|"~     Patients with single-level cervical degenerative disc disease commonly undertook anterior~     discectomy. To compare the effect of anterior cervical discectomy without fusion (ACD),~     anterior cervical discectomy with fusion by stand-alone cage (ACDF) or anterior cervical~     discectomy with arthroplasty (ACDA)， a multiple center randomised controlled trial will be~     performed in patients with single-level cervical disease. The primary outcome will be~     cervical alignment by upright cervical spine radiographs estimated by Harrison posterior~     tangent method.~   "
15779|NCT03360396|"~     This study will look at outcomes between Endobronchial Coil Treatment and Control groups in~     patients with severe heterogeneous and or homogeneous emphysema.~   "
15780|NCT03360383|"~     Percutaneous vertebroplasty is now a common procedures of patients with acute osteoporotic~     vertebral compression fractures in medical units all over China, but the efficacy and~     essentiality of the surgery remain uncertain and is the subject of this study. This is a~     multiple center open-label randomised trial. Patients were randomly allocated to percutaneous~     vertebroplasty or conservative treatment. Because of the procedure , neither patients nor~     investigators were blinded. The primary outcome was pain relief at 1 month and 1 year.~   "
15831|NCT03359707|"~     ACSES aims to describe the health behaviours and vulnerabilities of poor urban communities~     living in the greater Cayenne area. It was a questionnaire based study conducted around a red~     cross truck providing testing.~   "
15781|NCT03360370|"~     Children with congenital heart disease are at risk for neurodevelopmental disorders, these~     disorders impacting their quality of life and their integration into society.~      The aim of this study is to detect neurodevelopmental disorders in children (aged from 6 to~     66 months) with congenital heart disease in Nord-Pas-De-Calais (France) and to evaluate the~     frequency and risk factors of these neurodevelopmental disorders for a better follow-up.~      This study will help implementing a specific program for the evaluation and management of~     neurodevelopmental disorders in children suffering from congenital heart disease in~     Nord-Pas-De-Calais and more globally, in the region Hauts-De-France.~   "
15782|NCT03360357|"~     A recent survey of obstetrics and gynecology fellowship program directors showed that~     graduating OB/GYN residents may be underprepared for advanced laparoscopic training,~     necessitating an evaluation of the current structure of resident and fellow curriculum.~     Specifically, only 46% of first year fellows were able to independently perform an abdominal~     hysterectomy. Out of 28 residents tested using a previously validated laparoscopic cuff~     suturing model, only 8 (28.6%) passed the assessment.~      For this reason, it is necessary to identify the most effective and efficient educational~     approaches to obtain procedural proficiency. Time and effort has been placed in developing~     simulation programs. Simulation has shown promising outcomes in improving the performance of~     trainees and attending physicians with the ultimate objective of generating better surgeons.~     A previous meta-analysis of simulation-based educational assessments demonstrated that these~     assessments correlate positively with patient-related outcomes. However, there are limited~     studies with adequate validity to use simulation for summative evaluations of performance for~     gynecology residents. The widely used Fundamentals of Laparoscopic Surgery (FLS) program is~     used for credentialing of general surgeons, however, a systematic review suggested that more~     validity evidence is required to support its content (selection of tasks and scoring rubric)~     and the consequences (favorable and unfavorable impact) assessment. Although there has been~     an increase in the number of models available to teach OB/GYN common gynecologic procedures,~     there is a lack of evidence to support that these methods are actually allowing residents to~     create better surgical skills.~      To address the current limitations in OB/GYN training, the investigators have developed~     short, guided drills that cover the steps required for laparoscopic suturing and allow~     residents opportunities for deliberate practice. These drills will be tested compared to~     residents watching a laparoscopic suturing video and practicing using a high fidelity,~     suturing simulation model. Both of these methods are standard educational approaches for~     teaching laparoscopic skills, but it is unknown if one of the approaches is more effective~     than the other.~   "
15783|NCT03360344|"~     This randomized controlled trial graduate student research study will explore the effect of~     non-surgical intervention of the dorsal application of Kinesio Tape for carpal tunnel~     syndrome, and forearm wrist hand pain.~   "
15784|NCT03360331|"~     Evaluation of the calcifying effect of phosphorus on vascular smooth muscle and detect the~     association between serum phosphorus and valvular and vascular calcification in end stage~     renal disease patients~   "
15785|NCT03360318|"~     Commare the pain and function of Brace Versus Casting in Pediatric Radial Head Fractures~     after 1 month~   "
15786|NCT03360305|"~     GAPcare (Geriatric Acute & Post-acute Care Coordination Program for Fall Prevention) is an~     early stage investigation that enrolls older adults who present to the Emergency Department~     after a fall to determine the feasibility of an Emergency Department (ED)-based~     multidisciplinary intervention for preventing recurrent falls in older adults.~   "
15787|NCT03360292|"~     The investigators aim to measure the effect of targeting premature babies to a slightly~     higher oxygen saturation target range (92-97%) than routinely used, for a brief period, to~     plan a future larger study of the effect of this on clinical outcomes.~      It is still unclear exactly what levels of oxygen premature babies need - both too little or~     too much oxygen in the first weeks after birth may be harmful. Previous studies used~     saturation monitoring (SpO2), where a small probe shines light through the skin and~     calculates how much oxygen is carried in the blood. These studies demonstrated using an SpO2~     range of 91-95% rather than 85-89% was associated with more babies surviving and fewer babies~     suffering from a bowel condition called necrotising enterocolitis (NEC). However, targeting~     oxygen higher increased the number of infants who needed treatment for an eye condition~     called retinopathy of prematurity (ROP).~      It is possible an SpO2 range higher than 91-95% would be associated with even better~     survival. It is also possible that a higher range might not improve survival but could~     increase the need for ROP treatment.~      Infants born at less than 29 weeks gestation, greater than 48 hours of age and receiving~     supplementary oxygen would be eligible for inclusion. The study is at the Royal Infirmary of~     Edinburgh. Total study time is 12 hours for each infant (6 hours at the standard 90-95% range~     used in our unit, and 6 hours at 92-97%). It is a crossover study with infants acting as~     their own controls.~      Based on previous research the investigators are confident these oxygen levels will not be~     dangerously high. To provide an additional measure of oxygen the investigators will also use~     a transcutaneous monitor for the 12 hour study period, which fastens gently to the skin and~     measures oxygen and carbon dioxide levels on the skin surface.~   "
15788|NCT03360279|"~     Recurrent stenosis in hemodialysis access graft (AVG) is difficult to treat. For recurrent~     stenosis in the anastomotic junction can be treated by stent graft to improve long-term~     patency. However, there is no data regarding treatment of stent graft restenosis in AVG. This~     randomized trial is designed to compare the efficacy and safety of drug-coated balloon (DCB)~     versus regular balloon in AVG stent graft restenosis.~   "
15789|NCT03360266|"~     The remineralizing efficacy of 3 fluoride varnishes were assessed in children with white spot~     lesion under 6 years of age ( children with early childhood caries)~   "
15790|NCT03360253|"~     RCT to evaluate the safety and efficacy of Lactobacillus reuteri DSM 17938 to significantly~     reduce the duration of crying time and fussines in infants from 15days to 4 months of age~     with colic, feed with human milk (30% sample) or infant formula (70%)~   "
15791|NCT03360240|"~     Levels of blood pressure in adolescents with preeclampsia and eclampsia:~      Multicenter case-control study (Latin America). Maternities in Latin America: Two hospitals~     in Panama, one hospital in Mexico, one hospital in El Salvador, one hospital in Guatemala,~     two hospitals in Honduras, one hospital in Colombia, two hospitals in Peru and two hospitals~     in Bolivia.~      The objective is to evaluate the basal levels of blood pressure during pregnancy and~     determine if there is any increase that is associated with the development of preeclampsia~     and eclampsia without reaching the known values of 140/90 mm Hg.~      The sample is 718: (240 Cases and 478 Controls).~   "
15792|NCT03360227|"~     The implantable device therapy for cardiac arrhythmias has been an established therapy, and~     one of the common standard procedures in cardiac clinical practice.~      Pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy~     have been developed since 1960s, and the technologies in this field are still progressively~     developing. Not only these traditional implantable devices, there are multiple new devices~     for cardiac diseases, such as implantable loop recorder, vagal nerve stimulator and~     barostimulator.~      The aim of this registry is to demonstrate the efficacy and the safety of standard device~     implantation procedures and to evaluate/ identify specific factors, including clinical~     characteristics, laboratory data and procedural data, which predict the~     prognosis/complication of the patients. These identification will result in further~     improvement of patients' care.~   "
20975|NCT03292458|"~     Using a comprehensive approach of clinico-behavioral testing, neuroimaging and~     pharmacogenetics, the researchers will examine the clinical effects of sodium oxybate and the~     matched placebo on voice symptoms in spasmodic dysphonia and voice tremor.~   "
15793|NCT03360214|"~     This is a prospective randomized controlled double-blind interventional study comparing the~     effect of pulsed-electromagnetic field device (PEMF), pectoral interfascial block (PIB), and~     placebo on postoperative pain control. This study has the interdisciplinary cooperation of~     the regional anesthesia group, and the breast and plastic surgery divisions. All female~     patients with breast cancer evaluated at Columbia University Medical Center (CUMC) who are~     undergoing unilateral or bilateral mastectomy with tissue expander reconstruction will be~     offered enrollment in this prospective study.~   "
15794|NCT03360201|"~     The purpose of this study is to evaluate a family counseling intervention, entitled Tuko~     Pamoja (Translation We are Together in Kiswahili). The intervention, delivered by lay~     counselors and through existing community social structures, is expected to improve family~     functioning and individual mental health among members. The sample includes highly distressed~     families with a child or adolescent (ages 8-17) exhibiting emotional or behavioral concerns;~     as such, particular emphasis is placed on adolescent-focused outcomes, including mental~     health and well-being.~   "
15795|NCT03360188|"~     A medical record review of historic and current information on 237 patients attending 5~     tertiary referral centers [Kasr Al-Ainy Multiple Sclerosis Research Unit (KAMSU) - Cairo~     University Hospitals, Abo El Reesh Pediatric Hospital and 3 private centers] in Cairo, Egypt~     from period between 2011 and December 2015.~      Initially, medical records of 251 patients with the first acquired demyelinating events~     started before age of 18 years were reviewed. Fourteen patients (5.58%) were excluded due to~     missing data that could not be obtained.~   "
15796|NCT03360175|"~     The aim of the current pilot study is to investigate whether perioperative dysregulated~     systemic lipid mediator pathways (more specifically increased pro-inflammatory and decreased~     anti-inflammatory pathways) are associated with slower resolution of pain after surgery and~     increased risk for development of persistent postsurgical pain (PPSP). In addition, we will~     look for correlations between the pro-resolving lipid mediator profile and Quality of~     Recovery (QoR-15), duration of hospital stay, and frequency of complications, e.g. wound~     infections.~   "
15797|NCT03360162|"~     The use of ultrasonography in detecting giant cell arteritis ( GCA) is emerging. Currently,~     temporal biopsy is the gold standard to diagnose GCA but studies have shown the interest to~     use B mode ultrasonography. However, until now, the study of velocities in GCA have not been~     yet performed.~   "
15798|NCT03360149|"~     Prenancy and specialy delivery for hemophilia mother and her children possibly hemophilia is~     risked.~      Diagnostical of hemophilia pregnan is the first difficulty but patients with hemorrhagic~     menstruation without etiology known, hemorrhagic complication during a chirurgical procedure~     or during previously pregnancy currently are examine in Haemostasis consultation.~      None French recommendation specifie for health practice of these hemophilia patients exists.~     However, Anglo-Saxon recommendations are published in 2011.~      The objective of this study is to realize a French investigation of health practice about~     hemophilia care of these patients and to compare them with the English reference table.~   "
15799|NCT03360136|"~     Stress-related mental disorders are today the leading cause of long-term sick leave in~     Sweden, and a large part of this increase is due to Clinical burnout, in Sweden called~     Exhaustion disorder (ED). Even though clinical guidelines recommend multi-professional~     rehabilitation (MPR) for ED, few studies have evaluated the effects of these treatment~     programs in clinical practice. This large-scale open clinical trial investigates whether MPR~     for ED seems to alleviate symptoms of ED and if it results in return-to-work.~   "
15800|NCT03360123|"~     This study will evaluate the perceptions of the effects of two anxiolytic medications~     commonly used during dental treatment in patients weighing 40 kilograms or more.~   "
15801|NCT03360097|"~     This study evaluates which transfer strategy will result in a higher probability of pregnancy~     in patients whose single best day 5 embryo resulting from an IVF cycle is classified as~     expansion grade <4 by Gardner and Schoolcraft classification. All cycles will be cultured to~     day 6 and half the patients will undergo a fresh embryo transfer and the other half a frozen~     embryo transfer.~   "
15802|NCT03360084|"~     Systemic air embolism is traditionally considered as an extremely rare complication of~     percutaneous lung biopsy. Current literature includes mainly case reports or small case~     series of SAE. Majority of cases resulted in cardiac and/or neurological symptoms, often~     causing death. In most reported cases, the diagnosis of systemic air embolism referred to~     clinical manifestations without radiological diagnosis at the time of the procedure. Hence,~     its incidence might be underestimated in case of asymptomatic patients. Immediate recognition~     of air embolism during the procedure has been reported as the main factor to minimize severe~     complications since specific management of patient can be initiated earlier.~      The purpose of this study is to retrospectively assess the incidence of systemic air embolism~     depicted at the time of the procedure on a whole thoracic CT, systematically performed after~     transthoracic lung biopsy in a large cohort of consecutive patients. Secondary objectives are~     to determine possible influencing factors and to evaluate clinical outcomes.~   "
15803|NCT03360071|"~     This is a randomized, parallel-group, double-blind, phase 2, single center, proof-of-concept~     study which will evaluate the effect of a preparation of FDA approved allergens (PMA) used as~     a sub-cutaneously administered immunotherapy for the management of allergic rhinitis~     (perennial and seasonal).~   "
15804|NCT03360058|"~     To ensure that patients who are overweight or obese and have type 2 diabetes are identified,~     receive personalised diabetes care, have the issue of weight raised and explained in a~     non-judgemental manner by staff in primary care, and are referred on to weight management~     services as appropriate ensuring equity of access across NHS Greater Glasgow and Clyde.~      Specific aims of the whole project:~        1. To improve GP/ primary care staff knowledge of the evidence base for the management of~          diabetes when there is co-existing obesity and local care pathways~        2. To increase GP/ primary care staff knowledge of and confidence in their role in raising~          the issue of weight management,~        3. To improve primary care referral rates of appropriate patients who are overweight or~          obese and have type 2 diabetes, and are ready to change to NHS funded weight~          management services~        4. To improve patient uptake of and attendance at NHS funded weight management services NB~          This is a service evaluation of a training programme being delivered by NHS Greater~          Glasgow and Clyde Health Improvement. Full ethical approvals are being sought due to the~          randomised design and so that results can be generalised and published.~   "
15806|NCT03360032|"~     Idiopathic pulmonary fibrosis (IPF) is a chronic and potentially fatal lung disease. As IPF~     progresses, patients become increasingly breathless with reduced exercise capacity and~     quality of life. A cardiopulmonary exercise test (CPET) is a gold standard way of assessing~     patients with IPF.~      An incremental shuttle walk test is simpler, cheaper, more widely available and anecdotally~     preferable to CPET. The investigators will compare the measurements made in an ISWT and a~     CPET in patients with IPF . We aim to determine whether sufficient information can be~     gathered in an ISWT to negate the need to undertake CPET.~   "
15807|NCT03360019|"~     In this Phase II SBIR project we will enhance a wireless WiFi-based insole that was designed~     and successfully tested during a Phase I trial with elderly persons with dementia and their~     caregivers, and then investigate its efficacy in terms of caregiver activity, burden, and~     quality of life in Phase II. Evaluation will use semi-structured interviews and participant~     observation data collected from professional and family caregivers of patients with moderate~     or mild dementia.~   "
15808|NCT03360006|"~     This is an open-label, Phase 1, dose-escalation (Segment 1) and expansion (Segment 2) study~     to determine the maximum tolerated dose (MTD) and the recommended phase two dose (RPTD), and~     to assess the safety, preliminary efficacy, and pharmacokinetic (PK) profile of ABBV-744 for~     participants with metastatic Castrate Resistant Prostate Cancer (CRPC) and~     relapsed/refractory Acute Myeloid Leukemia (AML).~   "
15809|NCT03359993|"~     The investigators describe a simple and efficient method to give a premedication in the~     delivery room, using the umbilical vein, directly punctured through Wharton's jelly.~   "
15810|NCT03359980|"~     Patients who have a gastrointestinal acute Graft versus host disease (GVHD) received a~     first-line standard treatment of corticosteroids. For patients who do not respond or progress~     after an initial response have a high mortality. There is an interest in identifying~     effective second line therapy for these patients corticosteroid-resistant acute GVHD. Fecal~     microbiota transfer might be a beneficial treatment in this clinical situation with a poor~     prognosis and limited therapeutic options.~   "
15811|NCT03359967|"~     The CHILISALT Study aimed to explore the effect of angiotensin-neprilysin inhibition on~     intrathoracic impedance and -derived fluid index in HFrEF patients who had a device for~     cardiac resynchronization therapy and/or an implantable cardioverter-deﬁbrillator (ICD;~     Medtronic Inc., Minneapolis, MN) allowing continuous measurement of intrathoracic impedance.~   "
15812|NCT03359954|"~     The goal of this clinical research study is to compare changes to the tumor(s) in your breast~     before and after radiation.~      Radiation treatment is standard treatment after surgery for women with breast cancer. This~     radiation treatment is typically delivered to the larger breast area for 3-5 weeks of~     treatment, followed by 1 week of treatment (called a radiation boost) to the area where the~     tumor used to be. In this study, the radiation boost will be given before surgery rather than~     after it.~      Researchers want to learn about how radiation changes the immune system's response to the~     tumor, about side effects that develop after radiation treatment, and how radiation kills~     breast cancer cells.~      This is an investigational study. The radiation treatment will be delivered using~     FDA-approved and commercially available methods. The timing of the radiation boost is~     considered investigational.~      Up to 20 participants will be enrolled in this study. All will be enrolled at MD Anderson.~   "
15813|NCT03359941|"~     Patients with vertebral compression fractures (VCF) may experience pain, limitation of daily~     activities, and various complications (e.g., insomnia, constipation, urinary infection,~     depression, diminished quality of life).~      Objective:~      This study aims to evaluate the effectiveness, safety and feasibility of acupuncture~     treatments to achieve pain relief and functional recovery in patients with VCF.~   "
15814|NCT03359928|"~     Randomised cross-over study seeking to explore the acute physiological and perceptual~     responses to three novel forms of high-intensity interval training (HIT).~   "
15815|NCT03359915|"~     This study will randomise people with clinically significant COPD (GOLD Grade B-D) to usual~     care or provision of a self-management action plan supported by monthly follow-up visits from~     a community health worker trained in the use of the action plan. The primary outcome will be~     health-status: a comparison of the change in St. George's Respiratory Questionnaire (SGRQ)~     between baseline and 12 months in the two groups. We will randomise 240 people from three~     low- and middle-income countries, namely Nepal, Peru and Uganda. We will also examine the~     feasibility of implementing our self-management action plan intervention at scale.~   "
15816|NCT03359902|"~     Patients with amnestic mild cognitive impairment (MCI) often have compromised quality of life~     (QOL). Cognitive impairment is a major contributor to decrements in QOL and progression of~     MCI often leads to loss of independence and withdrawal from social participation. MCI, in~     many patients, is an early expression of neurodegenerative disease. Patients with MCI~     frequently convert to Alzheimer's disease (AD) (12-16 percent by some estimates per year).~     Treatments for MCI are of limited scope and availability and of limited effectiveness. Thus,~     there is great need for treatments that can improve cognition and extend QOL in patients with~     MCI. The investigators propose to investigate the effect of a non-invasive and safe~     intervention that should have direct influence on brain systems underlying AD, transcutaneous~     vagal nerve stimulation (tVNS).~   "
15817|NCT03359889|"~     This program will be initiated after the commercial availability of PraxbindTM in India. It~     will include patients administered with PraxbindTM into the surveillance program after~     commercial availability in 2 years at selected centres approved by the regulatory authority.~   "
15818|NCT03359876|"~     The objective of the study is to evaluate the effectiveness and safety of the reduced dose~     rivaroxaban (15 mg once daily) as compared to warfarin in non-valvular atrial fibrillation~     (NVAF) patients with renal dysfunction in routine clinical practice. The study has a~     retrospective design, and will be conducted in the US Truven Health MarketScan Commercial~     Claims and Medicare Supplemental Databases~   "
15852|NCT03359434|"~     A monocentric, non-randomized, prospective study in which each patient is his/her own~     control.~      The study investigates 2 methods of blood pressure measurement, within the first 24 hours~     after reperfusion, i) Continuous measurement of blood pressure with the Clearsight device~     (Edwards) and ii) intermittent blood pressure measurements with cuff.~   "
24100|NCT03251521|"~     The aim of the study was to analyze which step of the procedure of toxin botulinum injection~     is the most painful between skin break-in, electric stimulation, injection and needle~     withdrawal.~   "
15819|NCT03359863|"~     Despite advances in lung transplantation, the median survival remains only 55% at 5 years.~     The main limitation to long term survival is the development of chronic lung allograft~     dysfunction. In approximately 30% of cases, chronic lung allograft dysfunction has a~     restrictive phenotype (RCLAD) characterized by fibrosis with rapid progression to respiratory~     failure. Approximately 60% of patients with RCLAD die within one year, as currently there are~     no therapies available.~      RCLAD, like Idiopathic Pulmonary Fibrosis (IPF), is characterized by fibroblast~     proliferation, extracellular matrix deposition, and architectural distortion leading to~     progressive lung scarring and death. Given their similarities, there is keen interest in the~     international transplant community to investigate whether the anti-fibrotic drug pirfenidone~     can slow the progression of RCLAD as it does of IPF. Pirfenidone has been proved to be safe~     and effective in patients with IPF, and is approved by the Food and Drug Administration.~      This protocol will evaluate the safety and tolerability of pirfenidone in lung transplant~     recipients with RCLAD. Transplant recipients take carefully adjusted immunosuppressive~     medications for life to prevent rejection of the allograft. Current literature suggests the~     dose of tacrolimus, the main anti-rejection drug, may need to be adjusted when taken in~     combination with pirfenidone. The investigators will assess the side effects of pirfenidone~     in combination with the immunosuppressive regimen and determine the magnitude of the~     adjustment in tacrolimus dose. The results of this pilot study will provide the foundation~     for a multicenter randomized control trial to evaluate the efficacy of pirfenidone in slowing~     the progression of RCLAD.~   "
15820|NCT03359850|"~     Niraparib (Zejula®)is extensively metabolized and eliminated primarily by hepatic and renal~     pathways. The purpose of this study is to evaluate pharmacokinetics and safety of niraparib~     in patients with moderate hepatic impairment, for the purpose of providing recommendations to~     guide the initial dose and dose titration in this patient population.~   "
15821|NCT03359837|"~     Primary Objective:~      To test the hypothesis that basal insulin based treatment (G+) is noninferior to twice-daily~     premixed insulin (PM-2) in term of hemoglobin A1c (glycosylated hemoglobin, HbA1c) reduction~     from baseline to end of study. The test for superiority can be done if noninferiority is~     achieved.~      Secondary Objectives:~        -  To assess efficacy in terms of percentage of patients achieving HbA1c <7% and HbA1c <7%~          without hypoglycemia.~        -  To assess efficacy in terms of percentage of patients achieving fasting plasma glucose~          (FPG) <7 mmol/L and FPG <7 mmol/L without hypoglycemia.~        -  To assess safety in term of occurrence of moderate/severe hypoglycemia.~        -  To assess daily blood glucose (BG) variation.~        -  To assess patient satisfaction.~   "
15822|NCT03359824|"~     This study investigates the brown adipose tissue (BAT) activation and metabolism using~     positron emission tomography (PET) imaging before and after exercise training intervention at~     fasting state under normal room temperature and during cold stimulation.The investigators~     hypothesize that BAT glucose uptake is increased after exercise and BAT becomes metabolically~     more active.~      Understanding the mechanisms of BAT activation and the role of exercise in humans is crucial~     to combat epidemic of obesity and diabetes.~   "
15823|NCT03359811|"~     The goal of this clinical research study is to compare the effects of 4 quadrant TAP block~     (4Q-TAP block) with the standard-of-care thoracic epidural analgesia (TEA) in patients~     recovering from cytoreductive surgery with hyperthermic intraperitoneal chemotherapy~     (CRS-HIPEC).~      A 4Q-TAP block is also known as an abdominal wall block and TEA is also known as a thoracic~     epidural. Both are types of anesthetics but are given in different ways. A 4Q-TAP block is~     when anesthetic injections are given in 4 different parts of the abdomen. A TEA is when an~     anesthetic injection is given in the space surrounding the spinal cord through your back.~      This is an investigational study. The surgery and the levels of anesthetic participant is~     receiving are standard-of-care. It is investigational to compare 4Q-TAP block with TEA.~      Up to 140 participants will be enrolled in this study. All will take part at MD Anderson.~   "
15824|NCT03359798|"~     This study is a randomized controlled trial to investigate the effect of a simple counseling~     intervention on post-operative narcotic requirements, with the hypothesis that women~     receiving this intervention will use fewer narcotics for pain management following cesarean~     section.~   "
15825|NCT03359785|"~     The purpose of this study is to determine whether TAK-831 is superior to placebo in improving~     the average percentage of conditioned responses during the eyeblink conditioning (EBC) test.~   "
15826|NCT03359772|"~     Objective: To determine the effectiveness of balance training with Kinesthetic Ability~     Trainer 2000 (KAT 2000) in patients with peripheral neuropathic pain related balance~     disorder.~      Methods: A total of 60 patients who developed peripheral neuropathic pain-related balance~     impairment in the chronic phase due to lumber disc herniation, lumber spondylosis and~     gonarthrosis were included into this randomized controlled prospective study and randomized~     into either balance exercises groups or KAT 2000 exercises groups. Balance exercises were~     given all patients in Group 1 (n=30). In addition to balance exercises, KAT 2000 balance~     exercises were given all patients in group 2 (n=30). All patients received 45-min~     individualized training session for three times a week for 4 weeks. Patients were evaluated~     according to pain, static and dynamic balance and quality of life (QoL).~   "
15827|NCT03359759|"~     Observational study about patients treated for a metastasis breast cancer who live far from~     their comprehensive cancer center and followed by telemedicine, connected wtaches and~     patient-reported symptom monitoring.~   "
15828|NCT03359746|"~     This is a prospective, interventional, case-control study at King Faisal Specialist Hospital~     & Research Centre in post-renal transplant patients who are receiving Grazoprevir/Elbasvir~     combination. Data will be compared with matched historical controls, which will be selected~     according to the following matching criteria: age, time from transplant to initiation of~     therapy. Only patients who completed at least 48 weeks of pegylated Interferon + Ribavirin~     therapy in the control group and 12 weeks of therapy on the case group will be enrolled. Any~     patient who received at least one dose of Grazoprevir/Elbasvir combination will be included~     in the safety analysis.~   "
15829|NCT03359733|"~     The purpose of this study is to characterize the effect of food on the single-dose PK of~     TAK-659 in participants with advanced solid tumors and/or lymphomas.~   "
15830|NCT03359720|"~     determine the Knowledge attitudes behaviours and practices regarding HIV of men who have sex~     with men in the French Antilles and French Guiana~   "
15832|NCT03359694|"~     We plan to carry out a prospective, randomized, open phase III clinical trial which sponsored~     by the Tianjin Medical University Cancer Hospital and Institute. The primary aim is to~     evaluate pCR of DT and ET regimen as neoadjuvant chemotherapy in the treatment of HER2~     negative Luminal B breast cancers and the correlation of pCR respectively with the~     susceptible gene mutation scores and differential protein identified by proteomics. For~     patients with pCR, the association between the 5 year DFS and susceptible gene mutation~     scores and differential protein identified by proteomics will be evaluated. All Non-pCR~     patients will receive NX chemotherapy for 4 cycles, and to evaluate correlations between 5~     year DFS of these patients respectively with susceptible gene mutation scores and~     differential protein identified by proteomics, and to evaluate the safety of neoadjuvant~     chemotherapy and sequential adjuvant NX regimen therapy. Meanwhile, we will verify~     susceptible gene mutation scores and differential protein identified by proteomics are~     significant predictors of HER2 negative Luminal B breast cancer chemotherapy sensitivity and~     prognosis, and explore the feasibility of susceptible gene mutation scores and differential~     protein in clinical application.~   "
15833|NCT03359681|"~     This is a double-blinded placebo controlled randomized trial examining the effect of~     metformin in non-diabetic patients with colon cancer on cell growth, immunological and~     metabolic changes. Patients are randomized to receive metformin 20 days before and 10 days~     after surgery. Tumor samples are examined for changes in level of cell growth and the~     composition of tumor cells in the tumor is examined. Blood samples are assessed for~     immunological markers and insulin resistance is measured. Cell proliferation, migration and~     adhesion are also examined in vitro by adding plasma obtained from the patients to colon~     cancer cell lines grown in culture.~   "
15834|NCT03359668|"~     Localized thyroid cancer is potentially curable. Before thyroid surgery, an ultrasound test~     is done to see if cancer has spread to the lymph nodes in the neck. Excellent for evaluation~     of the thyroid gland, this test has limitations in evaluating larger anatomic areas, like all~     groups of lymph nodes in the neck. It has a limited area of coverage making it difficult to~     define an area of interest, depends on the skill level of the person performing it, and is~     difficult to exactly reproduce on follow-up. For these reasons, CT is often performed in~     these patients but without intravenous (IV) contrast since iodine-based contrast agents may~     saturate the thyroid, limiting the usefulness of other iodine-based diagnostic and treatment~     options. However, contrast-CT can give more detailed information about tumor spread including~     spread to lymph nodes. We aim to determine if use of IV contrast agent during CT leads to~     earlier and more accurate detection of lymph node disease from thyroid cancer.~   "
15835|NCT03359655|"~     Dilatation of the cervix is necessary before operative hysteroscopic procedures. This~     dilatation with Hegar dilators has certain difficulties and is associated with pain. Cervical~     priming with various substances soften the cervix, ease the entry for the operation and~     decrease complications such as uterine perforation.~      The investigators aimed to compare rectally administered misoprostol and hyoscine butyl~     bromide with sham protocol.~   "
15836|NCT03359642|"~     Spondyloarthritis and inflammatory bowel diseases are common diseases, frequently met~     together in overlap syndromes. Their physiopathology remains puzzling. A strong role of gut~     microbiota has been recently put forward to explain the development of inflammatory bowel~     diseases, and is suspected to play an important role in rheumatoid diseases. Anti-Tumor~     Necrosis Factor (anti-TNF) alpha are effective and safe drugs in the treatment of both~     digestive and rheumatoid inflammatory diseases. The way they work is unclear, and the~     clinical response to this treatment is variable. A better understanding of the~     pathophysiology of inflammatory bowel diseases and of the action of anti-TNF alpha is~     essential to an optimized care.~      Our hypothesis is that the efficacy of anti-TNF alpha in spondyloarthritis and in~     inflammatory bowel diseases is at least partly due to its restoring action of homeostasis at~     the interface between gastrointestinal mucosa and intestinal microbiota, either by primary~     action on the digestive epithelium, allowing it to regain its control and tolerance functions~     toward mucosal microbiota, either by direct action on the intestinal microbiota, via an~     inter-reigns regulation.~      The main objective of our study is to assess quantitative and qualitative changes in fecal~     microbiota before (D0) and 3 months after initiation of anti-TNF alpha.~   "
15837|NCT03359629|"~     Diabetes mellitus (or diabetes) is a chronic, metabolic disease characterized by elevated~     levels of blood glucose. Patients with diabetes need to monitor their blood glucose level~     several times a day to control their medical state. Modern biosensors have become a promising~     solution for non-invasive blood glucose measurements. This study aims to validate the~     efficacy and the accuracy of Glucometry Monitor (NIGM) developed by Spectrophon LTD~     incorporated in smart watches.~      Method Participants will use Spectrophon biosensors to non-invasively estimate the level of~     glucose in blood. Blood will also be collected and the glucose level will be checked with~     commercially available blood glucose analyzers . All sets of data will be compared to~     estimate the accuracy of measurements of Spectrophon NIGM~   "
15838|NCT03359616|"~     Total mesorectal excision (TME) has been prevailingly accepted as a crucial surgical~     intervention within the latest oncological therapeutic regime for mid-low rectal cancer.~     However, surgical dissection under the restricted pelvic anatomical structure, added by~     obesity and many other general factors, remains challenging for classical open and~     laparoscopic patterns, particularly in male cases. The introduction of transanal total~     mesorectal excision (TaTME) offers an optimal pattern for the surgical resection of mid-low~     rectal cancer, circumventing the conventional anatomical limits while bringing forward~     considerable advantages by direct dissection. Noteworthy, the surgical techniques of TaTME is~     initially established, with the mortality/morbidity and the oncological safety unverified.~     The studies that focus on the comparison between TaTME and laparoscopic TME (LaTME) remain~     sparse. Therefore, the features of TaTME, both in short and long terms, await further~     consolidation by clinical trials. Herein, this single centered, interventional study protocol~     is established to collect initial clinical data on both the safety and efficacy of the TaTME~     in comparison with LaTME in East Chinese patients with mid-low rectal cancer.~   "
15878|NCT03359096|"~     A new, well-tolerated treatment for obstructive sleep apnea - tongue stimulation - is a~     device which opens the airway during sleep and can provide treatment for patients unable to~     use the mask and hose treatment. The study will evaluate the effect of this new treatment on~     blood pressure and heart-related measures to see if it lowers patients' risk of heart~     problems.~   "
15839|NCT03359603|"~     Knee osteoarthritis (KOA) is one of the most common musculoskeletal diseases in clinic. It~     usually occurs in middle-aged people, especially women. An estimated lifetime risk for KOA is~     approximately 40% in men and 47% in women. KOA is a chronic disease which can lead to obvious~     pain, joint stiffness, limitation of activity and even disability, with significant~     associated costs and effects on society, health systems, and individuals. The use of~     acupuncture as an approach for the management of chronic pain, is receiving increasing~     recognition from both the public and professionals. However, there are no universally~     accepted treatment frequency criteria in previous studies. The number of acupuncture~     treatments is no more than twice per week in most previous studies, while it is usually 3-5~     sessions per week in clinical practice in China. The aim of this study is to compare the~     effects of different EA sessions (3 sessions per week versus once per week) in a pilot~     randomized controlled trial of KOA.~   "
15840|NCT03359590|"~     Sitagliptin, through its effects on sensitizing alpha-cell sensitivity to glucose, can~     initiate counter-regulatory glucagon responses at higher glycemic thresholds, thus reducing~     the number of clinically apparent hypoglycemic episodes, and/or ameliorating the severity of~     hypoglycemic episodes in the case that they should occur. The endpoints have defined such~     that consequences of this hypothesis can be measured.~   "
15841|NCT03359577|"~     The main objective of this study is to establish the efficacy and safety of Psorax35~     supplementation in patients with mild to moderate Psoriasis.~   "
15842|NCT03359564|"~     Evaluate the outcome of micro endoscopic discectomy (MED) by tubular retractors on safety and~     efficacy of the technique.~   "
15843|NCT03359551|"~     Choroideremia (CHM) is a rare, X-linked recessive, degenerative disease of the retina which~     begins in childhood with loss of night vision and gradually progresses to legal blindness by~     the fifth decade. There are no approved treatements for CHM and the disease is poorly~     characterised given its rare nature and scarscity of available data. The objective of this~     study is to collect natural history data from a large cohort of CHM patients in order to~     evaluate possible efficacy measures that could be utilised in future interventional trials of~     novel therapies.~   "
15844|NCT03359538|"~     In the last years research has pointed out potential mechanisms of pathogenesis in ALS~     including lack of degradation of abnormally accumulated proteins inside motor neurons, and an~     unbalanced function of the immune system leading to the prevalence of a neurotoxic function~     over neuroprotection. These two mechanisms contribute to ALS progression hence representing~     important therapeutic targets to modify disease expression.~      With a phase II clinical trial the investigators aim to study the biological response in ALS~     treated with Rapamycin, to obtain predictive information for a larger study.~      Eight Italian Centres will enroll 63 patients; treatment will be double blinded to patients~     and physicians, and will last 18 weeks.Follow up will be carried out for 36 months (total~     duration: 54 weeks).~   "
15845|NCT03359525|"~     Brief Summary Title: Prospective Randomized Trial Comparing Topical Versus Intravenous~     Tranexamic Acid (TXA) in Anterior (Total hip arthroplasty) Several strategies have been used~     to reduce transfusion requirements during total hip arthroplasty (THA). Recently,~     anti-fibrinolytic agent TXA, has been used extensively in THAs to minimize intra-operative~     blood losses. However, few studies have compared the efficacy of topical versus intravenous~     use in direct anterior THA. Therefore, the investigators will attempt to evaluate differences~     in the post-operative outcomes of topical versus intravenous TXA in Direct anterior approach~     to THA. The investigators propose to conduct a prospective randomized study in which patients~     who have exhausted non-operative treatment for hip osteoarthritis and are opting for THA will~     be randomized into 3 groups in a 1:1:1 ratio based on a computer generated algorithm~     following inclusion and exclusion criteria as described below. Patients will be distributed~     in to 3 groups as follows: Group A: Intravenous TXA at a dose of 1 gram administered 30 min~     prior to skin incision and 1 gram 3 hours after the procedure. (Total dose: 2 grams) Group B:~     Topical TXA at a dose of 1 gram injected in to the peri-articular tissues prior to closure~     and 1 gram injected into the joint through the drain following wound closure. (Total dose:2~     grams) Group C: Combined Intravenous 1 gram given intravenous 30 min prior to skin incision~     and topical TXA (1 gram) injected into the peri-articular tissues prior to closure. (Total~     dose: 2 grams). The number of subjects needed to achieve 90% power was calculated based on a~     one-way fixed effects analysis of variance with 3 levels. Primary endpoint used was drainage~     measured in milliliters in the post-operative (POD) #1 following surgery. Criterion for~     significance (alpha) was set at 0.05 and the ANOVA statistics was non-directional (two~     tailed). Preliminary data indicated that drainage volume averages 250 ml with a standard~     deviation of 160 ml in our operating room. Difference (maximum to minimum of the three~     levels) of 150 ml was judged to be the minimally clinically relevant difference in drainage~     volume (effect size =0.38). A 20% loss to follow up was also assumed. The study will need 38~     cases per cell for a total of 114 cases to achieve 90% power of detecting a difference this~     large. Data metrics will be tabulated into excel spreadsheets. Data analysis will be~     performed using statistical software. Quantitative data will be analyzed using~     non-directional analysis of variance (ANOVA) with Tukey's test for multiple comparisons.~     Non-normality or heteroscedasticity of data will either be corrected by transformation or a~     non-parametric (Kruskal Wallis) test will be used. Categorical data will be analyzed using~     chi-square tests (or Fisher's exact test if any cells expected value is 5 or less). A p-value~     <0.05 will be considered statistically significant.~   "
15846|NCT03359512|"~     Quantium Medical Company has an ElectoEcenphalograph-based (EEG-based) algorithm with two~     outputs: qCON for unconsciousness and qNOX for anti-nociception. qCON, is designed to provide~     information about the depth of the hypnotic state, similar to that provided by the BIS™.~   "
15847|NCT03359499|"~     Probiotics have been proposed as useful therapeutic alternatives for the treatment of~     irritable bowel syndrome patients. Bacillus clausii is a probiotic that has been used for the~     treatment of acute diarrhea among adults and pediatric patients, as well as an adjunctive~     therapy for the treatment for Helicobacter pylori infection. It has been proposed that~     Bacillus clausii is effective for the treatment of irritable bowel syndrome-related symptoms~     (especially diarrhea and bloating) in non-controlled trials. The aim of the proposed~     investigation is to determine whether the administration of Bacillus clausii during two weeks~     plus dietary advice compared to antispasmodics plus dietary advice would be an effective and~     safe alternative.~   "
15848|NCT03359486|"~     This is a pilot feasibility study of group problem management plus, a low-intensity~     psychological intervention, delivered in five sessions to adults affected by humanitarian~     crises. The current study will evaluate feasibility and acceptability of the intervention to~     determine procedures and content for a subsequent full trial using a cluster-randomized~     design of group problem management plus versus enhanced treatment as usual.~   "
15849|NCT03359473|"~     Impaired physical function and muscle dysfunction are a major consequence of COPD, which may~     be associated with increased mortality, poor quality of life and increased health care use.~     This is a randomized, placebo-controlled, double-blind, parallel group study to evaluate the~     safety and tolerability of GSK2881078, an SARM over 13 weeks of dosing in older male subjects~     and post-menopausal female subjects with COPD and muscle weakness. This study will also~     assess the effect of GSK2881078 on physical strength and function after 13 weeks of~     treatment. Approximately 100 subjects with COPD and muscle weakness will be randomized into~     two cohorts of 50 male subjects and 50 female subjects. Within each cohort, subjects will be~     randomized to receive GSK2881078 or placebo in a ratio of 1:1. All subjects will participate~     in a standardized home exercise program, which will consist of daily walking, along with~     several resistance or weight-bearing exercises, such as bicep curls, upright rows, step ups~     and a sit-to-stand maneuver. The study will consist of a screening/Baseline period of up to~     30 days, a 13-week treatment period and a post-treatment follow-up period of 6 weeks.~   "
15850|NCT03359460|"~     This phase I trial studies the side effects and best dose of ibrutinib when giving together~     with lenalidomide in treating patients with myelodysplastic syndrome. Ibrutinib may stop the~     growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as lenalidomide, work in different ways to stop the growth of cancer~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Giving ibrutinib and lenalidomide may work better in treating patients with~     myelodysplastic syndrome.~   "
15851|NCT03359447|"~     This study compares weekly versus daily administration of iron for prevention of anemia in 6~     months old infants. One third of the infants that are exclusively breast fed will not receive~     iron, the second third will receive iron weekly and the last third will receive iron daily.~     Half of the infants that take infant formula will receive iron weekly and the other half will~     receive iron daily.~   "
24101|NCT03251508|"~     The purpose of this trial is to provide salvage peanut oral immunotherapy for patients with~     peanut allergy.~   "
15853|NCT03359421|"~     Traumatic injury is the leading cause of pediatric death in the United States for those~     forty-four years of age and younger. Pediatric trauma patients generally have reduced~     mortality when treated at pediatric trauma centers rather than at adult centers or~     non-tertiary care facilities. However, nearly half the US pediatric population lives over~     fifty miles from a Level I or II Trauma Center. While air ambulances are readily available in~     many jurisdictions, few guidelines and little evidence dictate their appropriate use,~     especially with regard to pediatric trauma. Previous research is mixed regarding mortality~     benefit from helicopter Emergency Medical Services (EMS) in injured children. Previous~     attempts to develop appropriate field triage criteria have failed due to poor sensitivity and~     specificity for identifying the critically injured child. The current high rate of overtriage~     is particularly concerning in today's cost-conscious medical community. This research study~     aims to categorize pre-hospital pediatric trauma in North Carolina, to determine what~     benefits helicopter EMS provides in the North Carolina trauma system, and to formulate an~     enhanced screening tool for pre-hospital use to help determine which patients are suitable~     candidates for helicopter EMS transport.~   "
15854|NCT03359408|"~     Sectorisation of the German health care system causes inefficient treatment, especially in~     elderly with cognitive impairments. At time of transition from hospitals into primary care it~     lacks, among others, coordination of post-operative care or timely communication between~     healthcare providers. This results in deterioration of disease and comorbidities, higher~     rates of re-admission and institutionalizations. Models of collaborative care have shown~     their efficacy in primary care. Main goal is to test the effectiveness of Dementia Care~     Management (DCM) for people with cognitive impairment to improve treatment and care across~     the in-hospital and primary care sector.~      The study design is a complex, longitudinal, multisite randomized controlled trial. It was~     designed to treat a hospital-based epidemiological cohort of people above the age of 70 with~     an adaption of DCM, a treatment proven to be effective in primary care, to the discharge~     setting. As part of this, specifically trained study staff will develop, implement and~     monitor a treatment and care plan, based on comprehensive assessments during the hospital~     stay, recommendations at discharge and unmet needs at home. For the 3 months after discharge~     study staff will coordinate treatment and care in close cooperation with the discharging~     hospital, treating physician and other care providers.~      Expected results from the study should facilitate the implementation of intersectoral care~     management systematically on a large scale. Thus, the benefits shown in the trial would be~     available to a larger population. Results will not be limited to PCI, but rather to any~     people transitioning between the in-hospital and the primary care sector. Thus, the benefits~     would be available to elderly people in general.~   "
15855|NCT03359395|"~     Hemodynamic changes associated with the conduct of electroconvulsive therapy may be minimized~     with the administration of alfentanil as part of their anesthetic regimen. This study~     proposes to compare the effects in a blinded fashion. Currently alfentanil is an FDA approved~     drug used on a daily basis by anesthesiologists on other surgeries so this is not a new~     indication.~   "
15856|NCT03359382|"~     After anterior cruciate ligament (ACL) injury, the involved quadriceps may demonstrate~     weakness due to decrease in quadriceps activation. However, elapsed time from the injury may~     affect muscle strength by restoration of the quadriceps activation. The injury is~     characterized by joint instability that leads to decreased activity, unsatisfactory knee~     function, and poor knee-related quality of life in the short term, and it is associated with~     an increased risk of osteoarthritis on the knee. This study was designed to compare muscle~     strength, questionnaire and knee function in patients with different exercise training.~   "
15857|NCT03359369|"~     The primary outcome of this study is to evaluate the difference between the level of serum~     cholesterol and triglyceride in septic and non septic patients in the ICU. .~      The secondary outcome will be to find correlation between the level of serum cholesterol and~     triglyceride and both Acute physiology And Chronic Health Evaluation Score (APACHE) II(19)~     and quick Sequential Organ Failure Assessment (qSOFA) score (20) and their relation to~     mortality.~   "
15858|NCT03359356|"~     Alopecia areata is a medical condition, in which the hair falls out in patches. The hair can~     fall out on the scalp or elsewhere on the face and body. Alopecia areata is an autoimmune~     skin disease, which means that the immune system is recognizing the hair follicles as foreign~     and attacking them, causing round patches of hair loss. It can progress to total scalp hair~     loss (alopecia totalis) or complete body hair loss (alopecia universalis). The scalp is the~     most commonly affected area, but the beard or any hair-bearing site can be affected alone or~     together with the scalp. Alopecia areata occurs in males and females of all ages, and is a~     highly unpredictable condition that tends to recur. Alopecia areata can cause significant~     distress to both patients and their families. In this study, the aim is to assess the effects~     of dupilumab in patients with alopecia areata.~   "
15859|NCT03359343|"~     Linked color imaging (LCI)，a new endoscopy modality, creates clear and bright images by using~     short wavelength narrow band laser light. LCI can make red area appear redder and white areas~     appear whiter. Thus, it may be possible to distinguish adenoma and non-adenoma polyps based~     on color evaluation of LCI images. This study aimed to assess the correlation between~     histology results and LCI images. Moreover, the investigators conducted a pilot study to~     explore the clinical potential of LCI to distinguish adenoma and non-adenoma polyps and the~     accuracy of an automatic computer-aided diagnosis system using LCI imagine to predict~     histology polyps when compared to human experts physicians.~   "
15860|NCT03359330|"~     To observe the Mid-term clinical effect of biodegradable conduit small gap tublization to~     repair peripheral nerve injury in multi-center．~   "
15861|NCT03359317|"~     To test the changes in osteoarthritis according to the X-rays, and changes in bone quality~     before and 1 or more years after beginning the jogging~   "
15862|NCT03359304|"~     Neurofibromatosis-associated Tumor is very rare bone tumor. The investigator set up the~     biobank to ensure every patient has the chance to participate in future research~   "
15863|NCT03359291|"~     The aim of this Phase 1 trial is to study a potential drug-drug interaction between~     macitentan and rosuvastatin, a model substrate of various transporter proteins (e.g. in the~     gut).~   "
15864|NCT03359278|"~     To study the effects of ulnar styloid and sigmoid notch fractures on postoperative wrist~     function in patients with distal radius fracture~   "
15865|NCT03359265|"~     Erectile dysfunction (ED) is common, and is defined as persistent or regular inability to~     achieve or maintain penis erection for satisfactory intercourse. Approximately 3% to 71% of~     males have this problem as they age, and it is predicted that 320 million males worldwide~     will have ED by 2025. However, sex remains a topic that is too sensitive for most people to~     discuss openly. With advances in the sciences, medicine, and related studies, almost 95% of~     ED cases are treatable. ED therapies include oral medication, vacuum erection devices,~     intracavernosal injection, testosterone supplementation, surgery, and psychological~     counseling. In addition, germanium (Ge), titanium (Ti), and π elements are noble metals that~     can be used to produce far-infrared radiation, and are widely used to promote blood~     circulation. There has been little application of these metals to treatment of ED, but their~     use is worth investigating. This clinical trial recruited 30 subjects (a test group of 20 and~     control group of 10). Cellulosic textiles, incorporating noble metals (Ge, Ti, and π~     elements), developed by Green Energy Nano Technology Co., Ltd, were used in the test group,~     while commercially available regular textiles were used in the control group. In this~     clinical trial, the efficacy of the test products (improvement in ED) was assessed using~     questionnaires. Erectile function was assessed using the International Index of Erectile~     Function (IIEF-5) and the validated Portuguese version of the Quality of Erection~     Questionnaire (QEQ); premature ejaculation was assessed using the Premature Ejaculation~     Diagnostic Tool (PEDT); prostate symptoms were assessed using the International Prostate~     Symptom Score (IPSS). The questionnaires were completed once a month and followed up for 3~     months. The incidence of severe adverse effects was analyzed to assess product safety.~   "
15866|NCT03359252|"~     Perform a prospective cohort study to compare the incidence and severity of headache between~     non-stent assisted coiling and stent assisted coiling of unruptured intracranial aneurysms.~   "
15867|NCT03359239|"~     The purpose of this study is to determine the good and bad effects of atezolizumab given in~     combination with a personalized cancer vaccine in patients with urothelial cancer either~     after surgery to remove organ where the tumor arose (for example, removal of the bladder) or~     for urothelial cancer that has spread to other organs.~   "
15868|NCT03359226|"~     The purpose of this study is to perform biopsies of one of the glands that make saliva. The~     biopsied tissue will then be analyzed to see if it has changes that occur in Parkinson's~     disease. This study will determine whether it is possible to do a second biopsy a few years~     after a previous biopsy and determine whether there are changes in the biopsy that would~     allow for analysis of disease progression.~   "
15869|NCT03359213|"~     A Phase II open-label, randomized, parallel group, 2 sites (Brazil), designed to evaluate the~     safety and efficacy of 3 doses of study drug for the treatment of the MPS II.~   "
15870|NCT03359200|"~     This study aims to evaluate the microbiota of goldmann tonometers and its possible change~     over the visits~   "
15871|NCT03359187|"~     Prevention of radiation-induced mucositis in patients with head and neck cancer treated with~     radiotherapy : A Double-blind Randomized Controlled Trial~   "
15872|NCT03359174|"~     The purpose of this research study is to determine whether a low dose of ATRA will improve~     laboratory tests of liver and bile duct inflammation in patients with PSC. The investigators~     will also look for changes to other blood tests which are related to inflammation, scarring,~     and the immune system.~   "
15873|NCT03359161|"~     This study will evaluate the usefulness of the subcutaneous administration of a new Lasix~     formulation. 20 patients will be evaluated in the first phase (pilot phase) and depending on~     the results, an additional 40 patients will be enrolled (Evaluation Phase). Patients with~     mild to moderate evidence of fluid overload who present to the cardiology service at St~     Elizabeth's Medical Center, Brighton, Massachusetts (SEMC) will be included in the study.~     Patients who qualify for thus study will be sent home with the sc2Wear™ Furosemide Infusor~     therapy for three days. This is a pump that patients place on their abdomen and it then~     delivers furosemide to the skin. Participants will be visited at home by a visiting nurse who~     will give them further teaching on the sc2Wear™ Furosemide Infusor. The visiting nurse will~     also be responsible for obtaining history (symptoms), physical examination (including~     inspecting the skin for adverse reactions related to the pump), and laboratory draws,~     supplementation of electrolytes as needed. Patients will be evaluated by the cardiology~     service of SEMC within 24 hours of the last dose of the sc2Wear™ Furosemide Infusor. If a~     patient is found to have satisfactorily responded but requires more therapy, an additional 4~     days may be prescribed for total of seven consecutive treatments. If additional units are~     prescribed, patients will be evaluated by the cardiology service of SEMC within 24 hours of~     the last dose of the sc2Wear™ Furosemide infusion. Also an additionally, up to three-sc2Wear~     furosemide at home treatments may be used as authorized by the treating physician in case the~     patient experiences worsening heart failure within 30-days of enrollment (Rescue Treatment).~     Participants will be seen in clinic for follow up at 30±3 days after the start of the study~     for a post treatment.~   "
15874|NCT03359148|"~     Background: Few studies have investigated the difference of bacterial contamination between~     conventional reused ventilator systems and disposable closed ventilator-suction systems. The~     aim of this study was to investigate the bacterial contamination rates of the reused and~     disposable ventilation systems, and the association between system disconnection and~     bacterial contamination of ventilator systems.~      Methods: The enrolled patients used a conventional reused ventilator system and a disposable~     closed ventilator-suction system, respectively, for a week; specimens were then collected~     from the ventilators' internal system to evaluate human and environmental bacterial~     contamination. The sputum specimens from patients were also analyzed in this study.~      Results: The detection rate of bacteria in the conventional reused ventilator system was~     substantially higher than that in the disposable system. The inspiratory and expiratory limbs~     of disposable closed ventilator-suction system had higher bacterial concentrations than the~     conventional reused ventilator system. The bacterial concentration in the heated humidifier~     (HH) of the reused system was significantly higher than that in the disposable system.~     Positive associations existed among the bacterial concentrations at different locations in~     the reused and disposable ventilator systems, respectively. The predominant bacteria~     identified in the reused and disposable ventilator systems included Acinetobacter spp.,~     Bacillus cereus, Elizabethkingia spp., Pseudomonas spp., and Stenotrophomonas (Xan)~     maltophilia.~      Conclusion: Both the reused and disposable ventilation systems had high bacterial~     contamination rates after one week of use. Disconnection of the ventilator systems should be~     avoided during system operation for decreasing the risks of environmental pollution and human~     exposure, especially for the disposable system.~   "
15875|NCT03359135|"~     This study evaluates the effects of wearing a compression garment on the postural balance of~     patients with hypermobility type of Ehlers-Danlos syndrome, in randomised controlled study.~   "
15876|NCT03359122|"~     The aim of this study is to examine the association of COPD maintenance inhalation medication~     (Inhaled Corticosteroid or ICS) adherence with COPD exacerbation healthcare resource~     utilization among COPD patients with exacerbation history.~   "
15877|NCT03359109|"~     Slightly elevated blood metal levels have been found in adults undergoing hip and knee~     replacement. It is unknown whether pediatric patients with metal implant(plates/screws/rods)~     have elevated blood metal levels. This may have an impact on practice if children have high~     blood metal levels with routine orthopedic implants. If researchers find elevated metal~     levels, they may recommend patients to have the plates removed or may switch to a different~     type of metal. Further work on this topic is needed.~   "
15879|NCT03359083|"~     It has been shown that foot and ankle postural disorders can alter the biomechanic of lower~     extremity and pelvis. This situation can affects balance, postural control and phsical~     performance of individual adversely. However, it is unknown whether the muscles that control~     lumbopelvic are affected or not affected. The aim of this study is to investigate the~     relationship between foot-ankle characteristics and lumbopelvic control, balance and physical~     performance in healthy young adults.~   "
15880|NCT03359070|"~     This trial aims to evaluate the efficacy of dapaconazole tosylate 2% cream in the treatment~     of Tinea cruris compared to the active control miconazole nitrate 2% cream in patients with a~     single lesion.~   "
15881|NCT03359057|"~     This trial evaluated folic acid supplementation after oral administration of the ethinyl~     estradiol + levonorgestrel + folic acid (0.02 mg + 0.10 mg + 0.4 mg) coated tablet~     (Level-Fol® Biolab Sanus Farmacêutica, São Paulo, Brazil) in healthy female volunteers, based~     on statistical comparisons of folate levels in erythrocytes. Its safety and tolerability was~     also evaluated.~   "
15882|NCT03359044|"~     Fiberoptic bronchoscopy plays a very important role in the diagnosis and treatment of~     respiratory diseases in children.In China,this procedure is mainly performed under two~     different anesthesia methods：sedation and general anesthesia(GA) . Which is better ? there~     are still a lot of controversies . Several early retrospective studies suggest that, in~     addition to the possible increase in costs, general anesthesia in intraoperative~     complications, postoperative recovery and other aspects did not bring significant~     improvement. But clinically we observed that children under sedation often can not cooperate,~     they often shows anxiety,restless,crying,and so on, under these situation, some restraint~     measures may be used, which may have an impact on the child's neuropsychological development.~     Therefore ,we design this study ,aiming to compare the influence between sedation and general~     anesthesia (GA) on children 's neuropsychological development.~   "
15883|NCT03359031|"~     This study is a prospective, randomized trial. Our study aims to study the effects of~     perioperative patient education about compartment syndrome on patients' perception of their~     own pain, amount of opioid medication utilization, and rate of diagnosis of compartment~     syndrome.~   "
15884|NCT03359018|"~     After standard multimodal therapy, the prognosis of relapsed and unresectable high-grade~     osteosarcoma is dismal and unchanged over the last decades. We have already finished a~     prospective trial about apatinib for advanced osteosarcoma(NCT02711007) and find it has a~     objective response rate of aproximately 45% with median progression-free survival around 5~     months. Thus, the investigators explored apatinib activity together with anti-PD1 therapy in~     order to induce durable response in patients with relapsed and unresectable osteosarcoma~     after the failure of first-line or second-line chemotherapy.~      Apatinib is a small-molecule vascular endothelial growth factors receptor (VEGFR) tyrosine~     kinase inhibitor, similar to pazopanib, but with a binding affinity 10 times to VEGFR-2~     comparing with pazopanib or sorafenib.~      SHR-1210 is a humanized anti-PD-1 monoclonal antibody.~   "
15885|NCT03359005|"~     The investigators explored the activity of irinotecan combined with temozolomide in patients~     with relapsed and metastatic Ewing Sarcoma.~   "
15886|NCT03358992|"~     Response Evaluation Criteria in Solid Tumors (RECIST) are insensitive in evaluating primary~     sarcoma originated from bone treated with chemotherapy or targeted therapy, which did not~     have the definition of measurement methods either. This study evaluates whether clinical~     imaging findings of sarcoma after preoperative chemotherapy correlate with tumor responses by~     pathological evaluation by Huvos classifications and develops reliable, quantitative,~     clinical response criteria.~   "
15887|NCT03358979|"~     Modifications of cell surface markers (including EMMPRIN) were observed in conjunctival~     epithelial cells during dry eye syndrome ; this study aims to describe the modifications of~     the repartition of these cell surface markers before and after initiation of a treatment.~   "
15888|NCT03358966|"~     Patients with kidney disease need accurate advice on their diet. Researchers know very little~     about energy needs and nutritional requirements in kidney patients. Simple tools are needed~     to calculate calorie requirements so that good bed-side advice can be given to patients, and~     to allow cost-effective research. This study aimed to measur energy requirements in kidney~     disease using a gold-standard safe and very accurate method called the doubly labelled water~     technique. The study has compared measurements with less costly measurements obtained using~     a device which measures oxygen content of air breathed out. The study has also measured~     physical activity levels with questionnaires.~   "
15889|NCT03358953|"~     In Scotland tobacco-related illnesses account for in excess of 56,000 hospital admissions and~     a quarter of deaths each year. The resultant financial impact on NHS Scotland is over £300~     million per annum. To minimise the clinical and financial burden of tobacco on national~     healthcare systems, Scotland's tobacco control strategy aims to create a tobacco-free~     generation by 2034, with the prevalence of smoking in the adult population reduced to ≤5 %.~     The multifaceted approach focuses upon tobacco prevention, protection and cessation.~      In relation to smoking cessation, the use of EC has exponentially increased since 2011, and~     EC are presently the most popular nicotine replacement product used in England. The Public~     Health England (PHE) Report published in August 2015 advocates the use of EC when other~     smoking cessation aids have failed.~   "
15890|NCT03358940|"~     Non-medical used of misoprostol for abortion is a growing concern in Guadeloupe. Such~     situation is reasonable for countries in which abortion is not easy to obtain or prohibited.~     However regarding the risk of complications, it is less understandable in region like~     Guadeloupe where legal abortion with medical assistance is accessible for all and free.~      The aim of the study is to investigate on the amount of misoprostol taken by women in~     Guadeloupe, by doing an analytical measurement. The aim is to evaluate batter this practice~     in Guadeloupe, when the main objective of the study is to detect the presence or the absence~     of misoprostol in the urine sample of the woman coming at hospital for threatened miscarriage~     or miscarriage complications. Moreover, these abortions can be more important than~     spontaneous miscarriage.~   "
15912|NCT03358654|"~     This study was to evaluate the safety and efficacy of Mesenchymal Stem Cells (MSCs) from~     umbilical cord in the treatment of 7 knee OA patients by assessing unexplained local and~     systemic symptoms or death before and at 1, 2, 3, 6 months after the injection.~   "
15891|NCT03358927|"~     In the proposed R34 grant, the investigators will develop and test a strategy of immediate~     fast-track care. The study population will include adult patients with early HIV infection.~     Participants will be randomized to immediate fast-track or standard (deferred fast-track)~     care. All participants will receive same-day HIV testing and ART initiation prior to study~     enrollment. The intervention group will receive immediate fast-track care, which is~     conditional upon timely visits, and after 24 weeks in care, an undetectable viral load (HIV-1~     RNA <200 copies/ml). The standard group will be eligible to start fast-track care at 24~     weeks, if they are on time for that visit and have an undetectable viral load. Participants~     in either group who are >3 days late for any fast-track visit will lose fast-track care for~     that visit; those in either group with detectable viremia on their 24-week viral load test~     will be evaluated by a physician, with follow-up visits every 4 weeks until they have an~     undetectable viral load. Participants will be followed for 48 weeks. With the proposed pilot~     study, the investigators aim to conduct the formative work that is necessary to successfully~     implement a future clinical trial with the same primary outcome. The investigators~     hypothesize that immediate fast-track care will result in higher retention with viral~     suppression.~   "
15892|NCT03358914|"~     This study aims to develop and provide preliminary reliability and validity of a~     questionnaire to measure Health-related Quality of Life (HRQOL) in adolescents with~     psoriasis. To the best of our knowledge, this will be the first psoriasis-specific HRQOL~     instrument for use in adolescent patients. Data will be collected from a Danish population of~     adolescents with psoriasis (12-17 years), as well as from parents of adolescents with~     psoriasis, and a group of adolescents without psoriasis.~   "
15893|NCT03358901|"~     The study is designed to determine the safety, tolerability, and pharmacokinetics in healthy~     subjects with multiple intravenous administration of the neuroprotectant YC-6 compared to~     placebo.~   "
15894|NCT03358888|"~     This is a prospective, three-arm, comparative study with a provider-crossover design. The~     first arm will comprise the standard of care pain regimen after discharge, which comprises~     PRN oxycodone, tramadol, and acetaminophen. The second arm will comprise a multimodal pain~     regimen; however, patients will still be routinely provided PRN oxycodone and tramadol to use~     on an as needed basis. The third arm will comprise a multimodal pain management protocol,~     which does not routinely allow for opioid consumption. However, patients will be provided a~     one week supply of oxycodone and tramadol for emergency pain relief only.~   "
15895|NCT03358875|"~     The purpose of this study is to show that BGB-A317 will improve overall survival in subjects~     with Stage IIIB or IV non-small cell lung cancer when compared to docetaxel in second or~     third-line treatment setting.~   "
15896|NCT03358862|"~     Myopia has been increasing in prevalence and severity throughout the world over the last 30~     years. Increasing levels of myopia are associated with increased frequencies and severity of~     various ocular pathologies, including cataracts, glaucoma, retinal detachments and other~     retinal pathologies and myopic maculopathy. Slowing myopia progression at a young age before~     the eye reaches excessive axial length may help to reduce the future risks of these ocular~     pathologies.~      Conventional spectacles and contact lenses are prescribed correct myopia by moving the~     central focus of the eye for distance viewing from in front of the retina to on the retina~     centrally, or at the fovea. To varying degrees, these lenses allow the light to focus behind~     the retina, at varying peripheral retinal locations. These findings have led to efforts to~     design spectacle and contact lenses which correct peripheral hyperopic defocus, to reduce~     myopia progression.~      The consensus theory for how both multifocal contact lenses and orthokeratology can control~     myopia progression is that they each can reduce, eliminate, or reverse relative peripheral~     hyperopic defocus. Existing published studies on the use of multifocal contact lenses to~     control myopia in humans have utilized lenses with the distance correction in the center with~     peripheral plus power to correct the peripheral blur. Until recently, there have been no~     daily disposable multifocal lenses in the US market with distance center designs.~      The NaturalVue contact lens from Visioneering Technologies, Inc. is the first daily~     disposable distance center multifocal in the US. It has a novel extended depth of focus~     design where the distance correction is in the center of the optical zone, surrounded by a~     zone characterized by having a seamless, rapid transition from the distance power to a highly~     plus power at the edge of the optical zone.~      This study will analyze the myopia progression of patients in the investigator's practice~     while wearing their habitual visual corrections for periods up to two years prior to being~     switched to NaturalVue contact lenses. They will then be followed for up to two years after~     beginning use of this novel lens design and the differences in their myopia progression after~     versus before this novel lens will be analyzed. Axial lengths will be measured with the~     IOLMaster after switching to NaturalVue, at six-month intervals and will be compared to axial~     lengths which have been collected with habitual corrections.~   "
15897|NCT03358849|"~     Cholangiocarcinoma refers to bile duct cancer (bile duct cancer) and gallbladder cancer that~     develop in the gallbladder. According to the data from National Cancer Information Center in~     2013, the incidence of cancer in Korea is 5,283, which corresponds to about 2.3% of all~     cancers and the 5-year survival rate is 30% And most of the long-term survival is due to~     early detection by screening, and advanced carcinoma is a refractory carcinoma with a 5-year~     survival rate of less than 5%. In addition to the standard anticancer drugs, alternative~     anticancer drugs and targeted therapies have been developed to provide a variety of treatment~     modalities. However, the development of cell therapy drugs for cancer, such as cancers, has~     not been developed in Korea. .~      Natural killer cells (NK cells) are innate lymphocyte cells with cytotoxic activity. Unlike T~     cells and B cells, which have antigen-specific receptors, NK cells express various innate~     immunoreceptors on the cell surface, thereby enabling selective recognition of cancer cells~     And recognizes cancer cells, it is a cytotoxic cell that can immediately remove cancer cells~     without any other activation process. In addition, natural killer cells also interact with~     dendritic cells or T cells directly or indirectly to regulate the immune response, thereby~     inhibiting the development and metastasis of cancer cells and effectively removing cancer~     stem cells important for cancer recurrence It has many advantages in the development of~     anti-cancer immunotherapy.~   "
15898|NCT03358836|"~     This is a prospective, non-randomized, controlled study to examine whether or not having a~     higher trough during prophylactic treatment with clotting factor offers better joint~     protection than the standard trough of 1% Factor IX (FIX or Factor 9). This study will test~     the hypothesis that an extended half-life (EHL) FIX product with an intended trough of >10%~     could offer better protection than previous treatment concentrates. This study also examines~     whether or not joint damage could be diagnosed earlier using ultrasound images.~   "
15899|NCT03358823|"~     The aims of study on Angelman syndrome: (1)establish the Angelman syndrome database (2)to~     study the brain Network of Angelman Syndrome Based on Multi-modal Brain Image and Neural-EEG~     Data~   "
15900|NCT03358810|"~     This is a randomized, sham-controlled, patient masked, outcome assessor-blinded study to~     assess a Pharyngeal Electrical Stimulation (PES) Catheter for treatment of oropharyngeal~     dysphagia following a stroke.~   "
24116|NCT03251313|"~     This is a Phase I dose escalation trial to assess dose-limiting toxicity (DLT) and MTD of~     JS001+GP in advanced/metastatic TNBC patients, and to determine the recommended Phase II dose~     and the best combination regimen.~   "
15901|NCT03358797|"~     Arab women present increased risk for diabetes, with a 70% greater risk for adult-onset~     diabetes and a significantly younger age at onset compared with Jewish Israelis. In fact, the~     rate of diabetes for Arab women in Jerusalem is 4 times higher compared with their Jewish~     counterparts. Group lifestyle interventions such as the Diabetes Prevention Program (DPP)~     have documented effectiveness in preventing diabetes; however, many fail to demonstrate~     outcome maintenance. We predict that integrating leadership skills training into the gold~     standard DPP would improve the long-term outcome maintenance. A pre-post study design will be~     utilized, where all community participants will be exposed to intervention components. The~     sample was selected from pre-existing groups in the local community center, based on their~     leadership potential.~   "
15902|NCT03358784|"~     To explore clinical effectiveness of PHILOS plate fixation and hemi-shoulder arthroplasty in~     treating three or four-part fractures of proximal humerus~   "
15903|NCT03358771|"~     Chronic obstructive pulmonary disease (COPD) is a common, chronic progressive lung disease~     that is characterized by shortness of breath, activity limitation, and a predisposition to~     flare-ups resulting in frequent emergency department (ED) visits and hospitalizations. COPD~     flare-ups increase risks of disease progression and mortality and account for the greatest~     proportion of preventable hospitalizations among major chronic diseases.~      Evidence show that timely integrated disease management can prevent future COPD flare-ups and~     readmissions, but recent data indicate that appropriate follow-up after a COPD~     hospitalization is limited. To reduce this care gap, the investigators developed a discharge~     care bundle to help a patient that are being discharged from hospital or ED after COPD~     flare-up transition to community care.~      The aim of this study is to assess how effective and cost-effective is such bundle delivered~     alone or supported by the dedicated care manager. The investigators will be assessing~     reduction of ED and hospital readmission.~   "
15904|NCT03358758|"~     A retrospective morbidity and mortality study, using routinely collected data, investigating~     the epidemiology of patients with conflict-related injuries presenting to a dedicated trauma~     hospital in Erbil, Iraq, during the campaign to liberate Mosul from ISIS.~   "
15905|NCT03358745|"~     The order in which the different components of a meal are eaten may have impact on the~     postprandial metabolic responses to carbohydrates, fat and proteins. This study will compare~     blood lipids and glycemia regulation following lunches of identical composition but varying~     the order of intake of the different meal components.~   "
15906|NCT03358732|"~     Objective: To evaluate the effect of intrauterine navigation using intrauterine insemination~     catheter (IUI) one day prior to day 3 embryo transfer (ET) on pregnancy rate.~      Design: Pilot randomized controlled study. Setting: Tertiary referral center, King Fahad~     Medical City. Patients: Patients who underwent ET during the period of the study after two or~     less in-vitro fertilization failures and fulfilled the inclusion criteria.~      Interventions: Mock ETs were performed on day 2 post oocytes retrieval using intrauterine~     insemination catheter, followed by day 3 ET.~      Main Outcome Measure: Pregnancy rate.~      Key Words: embryo transfer, mock embryo transfer, endometrial receptivity, endometrial~     scratching, IVF.~   "
15907|NCT03358719|"~     This phase I trial studies the side effects of DEC-205/NY-ESO-1 fusion protein CDX-1401, poly~     ICLC, decitabine, and nivolumab in treating patients with myelodysplastic syndrome or acute~     myeloid leukemia. DEC-205/NY-ESO-1 fusion protein CDX-1401 is a vaccine that may help the~     immune system specifically target and kill cancer cells. Poly ICLC may help stimulate the~     immune system in different ways and stop cancer cells from growing. Drugs used in~     chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Monoclonal antibodies, such as nivolumab, may interfere with the ability of cancer~     cells to grow and spread. Giving DEC-205/NY-ESO-1 fusion protein CDX-1401, poly ICLC,~     decitabine, and nivolumab may work better in treating patients with myelodysplastic syndrome~     or acute myeloid leukemia.~   "
15908|NCT03358706|"~     The purpose of this study is to evaluate the potential effects of an intravenous (IV)~     induction and subcutaneous (SC) maintenance administration of ustekinumab on the~     pharmacokinetic (PK) of a cocktail of representative probe substrates of cytochrome P450~     (CYP) enzymes (CYP3A4, CYP2C9, CYP2C19, CYP2D6, and CYP1A2) in participants with moderate to~     severe Crohn's disease (CD).~   "
15909|NCT03358693|"~     This pilot project intends to examine the utility of a systems medicine approach to identify~     regulatory networks and their perturbation in psoriasis and atopic dermatitis, and to obtain~     a comprehensive perspective on disease and disease control by integrating and modelling data~     across multiple cellular levels and time following specific blockade of single~     pathophysiological factors through use of licensed biologics during routine care as systems~     biology challenge. To this end, ultra-deep phenotyping and prospective molecular~     characterization in short time-intervals and different disease equilibrium states will be~     carried out in targeted small sets of patients. The different layers and types of clinical~     and molecular information will then be integrated (integrative personal omics profiling iPOP)~     for generating insights into disease pathways and for extraction of molecular signatures that~     correspond to clinical severity scores. It will provide a good starting point for planning~     future trials aimed at identifying biological patterns useful for guiding targeted treatment.~   "
15910|NCT03358680|"~     In this study,~        1. Investigator will apply IOC2 to reflect the depth of analgesic during hypothermia in CPB~          period.~        2. Furthermore, investigator evaluated the effectiveness of IOC2 monitoring for anesthetic~          depth versus commonly used vital sign monitoring based on factors such as blood pressure~          and heart rate.~        3. Evaluate the other sedation co-relation measurement, include BIS , IOC2 to reflected the~          consciousness during the operation.~        4. Evaluate the other hemodynamic index, include CO, SVV, CVP, PPV to reflect the~          circulation function , and the effect to the IOC2 and IOC1.~        5. Describe the trend of all the measurement. detect the variation of the index during the~          temperature change during the CPB.~   "
15911|NCT03358667|"~     The objective of this observational study is to evaluate the growth of peri-implant soft~     tissues using an heterologous dermal membrane graft (group A) or a 2 mm healing screw used as~     a vertical support of the limbs (group B) positioned at the moment of surgical insertion of~     the implant.~   "
24117|NCT03251300|"~     The aim of this study is to elucidate whether night-time dosing of mirebegron can improve~     nocturia, compared with daytime dosing of mirabegron.~   "
15915|NCT03358615|"~     Robson classification of Cesarean section rates and indications allows evaluation and~     comparison of the contributors to the Cesarean section rate and their impact. It also allows~     comparison between institutions, regions, and countries that adopt this classification~     Robson's system classifies all deliveries into one of ten groups on the basis of five~     parameters: obstetric history (parity and previous cesarean section), onset of labor~     (spontaneous, induced, or cesarean section before onset of labor), fetal presentation or lie~     (cephalic, breech, or transverse), number of neonates, and gestational age (preterm or term;~     panel This study evaluates C.S rates and indications according to Robson classification in a~     University Hospital in a year (2016) to compare with international standards~   "
15916|NCT03358602|"~     Supraglottic cancer is a main type of laryngeal carcinoma, which is one of the most common~     head and neck tumors. Cervical nodal metastasis is an important prognostic factor in~     supraglottic cancer. Current management, following the US National Comprehensive Cancer~     Network guidelines for T1-2, N0 supraglottic cancer (NCCN 2017), is either definitive~     radiotherapy or primary surgery with or without neck dissection. The optimal neck treatments~     strategy remains unclear in clinical settings owing to the limitation of a small number of~     retrospective studies and a lack of prospective trials. The investigators conducted a~     prospective, randomised trial to compare radiotherapy with neck dissection.~   "
15917|NCT03358589|"~     Background: Despite that up 90% of patients with early-stage breast cancer receives adjuvant~     treatment, there are still about 300 patients diagnosed with primary metastatic breast cancer~     (MBC) and about 1,200 patients who develop metastases after the primary treatment each year~     in Denmark.~      Aim: The investigators hypothesize that molecular evaluation with FDG-PET/CT and diffusion~     weighted MRI allows an earlier detection of failure to respond to potentially toxic drugs in~     patients receiving breast cancer directed treatments.~      The aims of our project are to address the following questions:~        -  Does FDG-PET/CT allow an earlier detection of failure to respond to treatment for MBC~          than conventional CT?~        -  Does FDG-PET/CT or MRI allow an earlier detection of failure to respond to treatment for~          bone metastatic disease than conventional CT?~        -  Does the PET based criteria (PERCIST) have the potential to lead to changes in the~          treatment plans made from CT based criteria (RECIST)?~        -  Does FDG-PET/CT give a more accurate diagnosis of MBC than conventional CT in terms of~          number and distribution of metastatic sites?~      Method: Part A - the accuracy study: The study population will comprise all women referred to~     Odense University Hospital with suspected metastatic breast cancer (MBC). The investigators~     expect to include 270 patients who will be examined with FDG-PET/CT. If bone metastases are~     detected, the patients will proceed to MRI. All patients with suspected metastases on~     FDG-PET/CT or MRI will have a biopsy from a suitable lesion Part B - the response evaluation~     study: The investigators expect to include 90 patients with biopsy-verified MBC. Patients~     will receive oncologic treatment according to national guidelines. Response to treatment will~     be evaluated by conventional CT criteria and compared to novel criteria according to FDG-~     PET/CT, and MRI. Test results will be blinded to each other, so that knowledge of other test~     results will be unknown for the reader of the CT, FDG-PET/CT or MRI, respectively Expected~     clinical impact: This project represents a truly multidisciplinary effort to improve the~     diagnosis, staging, and response evaluation of MBC. The investigators hope that patients will~     benefit in terms of being spared for ineffective toxic treatment due to earlier detection of~     failure to respond, and hence leading to earlier treatment transition. Patients are involved~     in the planning and conduct of the project.~   "
15918|NCT03358576|"~     This is a prospective, Phase 3, randomized, multi-center, double-blind study of the efficacy,~     tolerability and safety of sulopenem followed by sulopenem etzadroxil with probenecid versus~     ertapenem followed by ciprofloxacin-metronidazole or amoxicillin-clavulanate for treatment of~     complicated intra-abdominal infections in adults.~   "
15919|NCT03358563|"~     This is a pilot multimodality treatment approach trial with androgen deprivation therapy in~     combination with docetaxel chemotherapy followed by radical prostatectomy in patients with~     newly diagnosed high-risk and oligometastatic prostate cancer. This study aims to evaluate~     the rates of complete pathologic response (pCR) at the time of prostatectomy as well as PSA~     response, time to PSA recurrence and safety and toxicity of the combination. This study will~     be heavily embedded with biomarker analyses of the tumor and tumor cells in circulation as~     well in the bone marrow before and after treatment and will also include imaging analyses~     using a novel positron emission tomography (PET) imaging technology.~   "
15920|NCT03358550|"~     Shifts in accommodation at decreasing luminance levels are considered as principle cause for~     night myopia. Previous studies with laser optometers quantified the dark focus of~     accommodation up to 3 D. In addition to the measurement of dark focus, the aim of this study~     was to investigate the influence of an imaginary target at finite distances on the state of~     accommodation at scotopic luminance.~   "
15921|NCT03358537|"~     This was a randomized, endoscopists' blinded comparison of bowel colonoscopy cleansing and~     tolerability of a prespecified low-residue diet compared with a clear liquid diet and~     Polyethylene Glycol bowel preparation. Outcome measures included efficacy of bowel~     preparation, patient preparation tolerability and side-effects.~   "
15922|NCT03358524|"~     This study evaluate supplementation of vitamin E (alpha-tocopherol) in obese adolescent. Half~     of the patient will receive vitamin E and the other half received placebo~   "
15923|NCT03358511|"~     The purpose of this study is to find out if using probiotics will help the body's immune~     system react to breast cancer. New studies showed that diverse species of bacteria inside the~     bowel might help improve immune system, particularly the ability of immune system to~     recognize cancer. This study will investigate how probiotics will affect the subjects' immune~     system on breast cancer.~   "
15924|NCT03358498|"~     Regular blood transfusions are essential for the management of haematological conditions such~     as β-thalassemia major. As a result, however, patients with these conditions are susceptible~     to the development of transfusion-dependent iron overload (hemosiderosis or secondary iron~     overload~   "
15925|NCT03358485|"~     The purpose of this study is to evaluate the safety and tolerability of multiple doses~     escalation of Aolanti Weikang tablets to determine the MTD in healthy volunteers~   "
15926|NCT03358472|"~     The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus~     epacadostat, pembrolizumab monotherapy, and the EXTREME regimen (cetuximab + cisplatin or~     carboplatin + 5-fluorouracil) as first-line treatment for recurrent or metastatic head and~     neck squamous cell carcinoma (HNSCC).~   "
15939|NCT03358303|"~     Heart failure is the most rapidly rising cardiovascular disease and has come to be recognized~     as a growing epidemic. Digital health interventions are the most recent iteration of an~     effort to promote individualized outpatient care through positive behaviour change theory.~     The UHN team has developed a highly automated and user-centered smartphone-based system,~     Medly, which allows for the telemonitoring of patients diagnosed with heart failure. The~     purpose of this study will be two-fold: 1) to determine if the introduction of Medly within~     two weeks of discharge will improve self-care management, quality of life, and clinical~     status, 2) to assess whether Medly will lead to a potential reduction in 30 day readmission~     rates amongst HF patients in the Toronto Central Local Health Integration Network (TC LHIN),~     without increasing the average length of stay or visits to the emergency department. These~     parameters will be measured as secondary outcomes.~   "
15927|NCT03358459|"~     Epilepsy is a major disease of the nervous system (WHO, 2015), as well as the second most~     common neural disease. It has been recorded that there have been 65 million epilepsy patients~     all over the world, more than 10 million in China, resulted in high morbidity, high~     mortality, heavy social and social psychological burden. Due to complex etiology, which~     genetic playing a large part for 70%-80%, easy to recurrent, as well as various seizure~     types, a great heterogeneity in clinical manifestation, epilepsy is difficult to treat in~     general, at least 33% patients. At present, It's still a big challenge in early warning,~     choice of treatment, efficacy and severe adverse reaction rate, prognosis assessment. Lack of~     precise diagnosis based genetic and molecular bio-markers for treatment are the main key~     points. Recently, clinical phenotype classifications of epilepsy have been refined, the exist~     researches had made a progress in gene mutation mechanism and targeted therapy, which pushed~     epilepsy being another disease could be precise treated after tumor. It's sure to provide a~     breakthrough for another neural diseases if epilepsy precise treatment project are~     successful.~   "
15928|NCT03358446|"~     Evaluation for the range of smallest leg angulation with femoral artery and vein overlap with~     femoral central catheterization in pediatrics.~   "
15929|NCT03358433|"~     The main objective is to test the non-inferiority of supervised exercise versus~     antidepressant treatment in reducing depressive symptoms in patients with clinical criteria~     for depression (according to ICD 10) over a period of 6 months follow-up.~   "
15930|NCT03358420|"~     The aim of this study is to examine the correlation between the severity of non-alcoholic~     steatohepatitis/non alcoholic fatty liver disease (NASH/NAFLD) in naïve and hepatitis C (HCV)~     positive patients and the amplitude of alpha-defensin immunohistochemical staining in liver~     biopsy.~   "
15931|NCT03358407|"~     This study is the first administration of GSK2983559, a selective receptor interacting~     protein 2 (RIP2) kinase inhibitor, to humans. This will be randomized, double-blinded~     (sponsor open) and two part study (A and B). Part A of the study is single ascending dose~     crossover design with two separate cohorts (1 and 2). In Part A, 9 single dose levels will be~     explored. In Cohort 1, 10 healthy subjects will randomized to receive single oral doses of~     either GSK2983559 or placebo in a ratio of 4:1 in 5 way cross-over design with 5 treatment~     periods. In Cohort 2, 8 healthy subjects will be randomized to receive single oral doses of~     either GSK2983559 or placebo in a ratio of 3:1 in 4 way cross-overs design with 4 treatment~     periods. In Cohort 2 there will be an additional period (period 5-open label) for assessing~     GSK2983559 under fed conditions. There will be 48 hours wash-out period between each dose~     escalation period. Part B is repeat ascending dose sequential group design. It will contain 4~     Cohorts of and dosing will be done sequential dosing. Subjects in Part B will receive once~     daily (QD) dose or twice daily dose (will be decided based upon the pharmacokinetic, safety~     and tolerability observed in Part A). There will 58 subjects involved in this study. Total~     duration of Part A will be approximately for 11 Weeks and Part B will be approximately for 15~     Weeks.~   "
15932|NCT03358394|"~     Kuwait ranks as the third country worldwide for the incidence of type 1 diabetes (T1D) with~     an incidence of 37.10 per 100,000 children. A systematic review revealed that anxiety and~     depression are common in parents of children with T1D . Despite the high incidence rate, only~     one study to date has examined the psychological impact of diabetes on parents of children~     with T1D in Kuwait. It was found that 50.8% of parents had elevated levels of anxiety and~     46.7% had elevated levels of depression.~      Recent research shows that mindfulness is associated with a range of positive outcomes as~     well as decreased psychological and emotional distress. The earlier A doctor of philosophy~     (PhD) study found that mindfulness explained large amount of variance in anxiety and~     depression in a sample of parents of children with T1D. Mindfulness is defined as paying~     attention in a particular way, on purpose, in the present moment, and non-judgmentally. The~     model of mindful parenting can be taught and provided as an intervention to improve~     psychological outcomes in parents of children with long term health conditions.~      In line with this idea, one study examined the effectiveness of a mindfulness-based~     intervention on perceived stress and psychological anxiety among parents of children with~     autism spectrum disorder (ASD) in Jordan. The results indicated a significant decrease in~     stress and psychological distress in the intervention group compared to the comparison group.~     In the present pilot study, we will extend this work by evaluating a guided self-help a~     mindfulness intervention that aims to increase mindfulness and reduce psychological distress~     in parents of children with T1D in Kuwait.~   "
15933|NCT03358381|"~     Gap balance type and measured resection type total knee arthroplasty (TKA) have different~     influence on the rotation of femoral component.In this study, the rotation of patients~     received different type of TKA will be estimated and analysed through preoperation and~     postoperation knee joint CT scan.~   "
15934|NCT03358368|"~     The study is being performed to evaluate a new portable medical device, the Creavo Vitalscan~     Magnetocardiograph (Vitalscan) on patients who have had a confirmed myocardial infarction~     (heart attack) within the previous 12 weeks.~   "
15935|NCT03358355|"~     The GIFT pilot study will investigate the optimal subcutaneous dose and safety of~     subcutaneously administered unacylated ghrelin in older people with peripheral artery disease~     (PAD).~   "
15936|NCT03358342|"~     The investigators plan to further develop a prototype, evidence-based, electronic clinical~     decision support system (CDSS) for pneumonia care (ePneumonia) with interoperability across~     Electronic Health Records in order to improve clinical outcomes and reduce healthcare~     resource utilization. The specific aims of this study are to evaluate the usability of~     ePneumonia adapted for Cerner and its impact on clinical, patient-centered and healthcare~     resource utilization outcomes in a stepped-wedge implementation study in 16 hospital~     emergency departments (EDs) across the Intermountain Healthcare integrated health system.~   "
15937|NCT03358329|"~     The ENCORE Study is a non-randomized, open-label, multicenter study with 50 chronic sinusitis~     patients who had prior endoscopic sinus surgery but present with recurrent sinus obstruction.~   "
15938|NCT03358316|"~     To evaluate the association between rotator cuff tear and the proximal migration of humeral~     head~   "
15940|NCT03358290|"~     Study to evaluate the efficacy, safety, tolerability and pharmacokinetics of JTE-051~     administered for 12 weeks in subjects with moderate to severe plaque psoriasis.~   "
15941|NCT03358277|"~     Objectives:~        1. To investigate the effectiveness of adjuvant with aripiprazole to methylphenidate for~          disruptive mood dysregulation disorder (DMDD) in youths with~          attention-deficit/hyperactivity disorder (ADHD)~        2. To investigate the neural basis of chronic irritability in youths with functional~          magnetic resonance imaging (fMRI)~        3. To compare the clinical characteristics of youths with comorbid ADHD and DMDD to youths~          with ADHD only~   "
15942|NCT03358264|"~     Arginase has recently been implicated in an array of vascular conditions including~     atherosclerosis , hypertension and vascular complication of diabetes. In this study we will~     determine of L-citrulline; a natural amino acid that is known to have inhibitory effects on~     arginase activity, on vascular function in type 2 diabetic patients.~   "
15943|NCT03358251|"~     This study is a prospective open-label controlled study in which the Pocket-X Gel, a~     periodontal in-situ gelling product, or Pocket-X Chip, a periodontal film, will be applied to~     periodontal pockets in one/two mouth segment(s) of participants following scaling and root~     planing on the entire mouth, while the contra-lateral segment(s) will serve as control. The~     aim of the study is to investigate the safety and efficacy of Pocket-X Gel and Pocket-X Chip~     in improving the healing of the gingiva and preventing bacterial re-colonization in the~     periodontal pocket following scaling and root planing.~   "
15944|NCT03358238|"~     The goal of this study is to learn how to engage individuals with bipolar disorder in~     long-term monitoring of daily patterns of mood, stress, sleep, circadian rhythm, and medical~     adherence. Knowledge gained will be used to develop a mobile health platform for the~     translation of a psychosocial intervention for bipolar disorder into an effective adaptive~     intervention.~   "
15945|NCT03358225|"~     A muti-center study to compare the safety and efficacy of anterior cervical discectomy and~     fusion, cervical artificial disc replacement and hybrid surgery for bi-level cervical~     spondylosis.~   "
15946|NCT03358212|"~     This prospective observational study is going to figure out the safety and efficacy of~     denosumab as an post-operative strategy.All the patients enrolled will take denosumab~     according to the protocols.We focus on the recurrence rate after the drug withdrawl and~     possibility of malignant transformation.~   "
15947|NCT03358199|"~     To evaluate the effect of performing laparoscopic ovarian drilling (LOD) before proceeding to~     in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) on the cycle outcomes~     in polycystic ovarian syndrome (PCOS) patients with high antimullerian hormone (AMH) levels~   "
15948|NCT03358186|"~     To Investigate the Surgical Treatment effect of Periprosthetic Femur Fracture After Hip~     Arthroplasty~   "
15949|NCT03358173|"~     Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the~     Distal Clavicle~   "
15950|NCT03358160|"~     The aim of this study is to investigate the possible effects that a motor limitation at the~     peripheral level might have on the ability to visually discriminate others' actions.~      Previous literature has shown that specific motor skills (motor expertise) facilitate the~     visual discrimination of domain-specific actions, and that these motor experts' superior~     abilities might be mediated by areas not only responsible for the visual recognition of~     movements (as it happens in non-expert subjects) but also involved in motor planning.~     Similarly, impairment in the motor system due to neurological damage modulates not only the~     ability to perform movements but also the ability to discriminate and predict the temporal~     course of observed actions.~      Based on these findings, it has been hypothesized that the motor representations of gait,~     despite being a hyper-learned motor pattern, might be subjected to modification as a result~     of an impairment of walking caused by a peripheral functional limitation in the lower limbs~     as the one characterizing orthopaedic patients who underwent a surgical operation for total~     knee arthroprosthesis. In this protocol, patients are thus required to perform visual~     discrimination tasks based on the observation of movements performed with either the upper or~     lower limbs, and their performance is expected to correlated with their functional~     impairments in movement execution.~      These results would indicate that the (in)ability to perform a movement might have an impact~     on its representation at the central level and on internal motion simulation capabilities,~     which also influence the ability to visual discriminate others' actions through~     action-perception transfer: this would suggest that rehabilitation in orthopaedic patients~     should take into account (and restore) such a central impairment in motor representations.~   "
15951|NCT03358147|"~     Study Comparing the Efficacy and Safety of PT001 to Placebo and Open-label Spiriva® Respimat®~     in Subjects With Persistent Asthma~   "
15952|NCT03358134|"~     The purpose of this study is to determine the mechanism of action on target tissue level of~     anti Interleukine-17 (anti-IL-17) an therapy in peripheral spondyloarthritis.~      Patients will be treated with anti-IL-17 therapy (secukinumab) for 12 weeks and with a 2 year~     extension period thereafter.~      At week 0 and 12 peripheral blood, synovial tissue and skin will be analysed with different~     techniques, including immunohistochemistry, RNA analysis and tissue culture to assess the~     effect of the therapy on inflammatory pathways.~   "
15953|NCT03358121|"~     The study entitled  Asprosin Dynamics relating to serum Glucose levels under controlled~     alterations investigates the dynamics of Asprosin in relation to glucose levels under~     controlled conditions in diabetic patients.~   "
15954|NCT03358108|"~     This is a prospective, multicentre observational follow-up study of PegIFN treatment~     unstained response in nucleoside experienced patients with Chronic Hepatitis B.Patients will~     join this study after finished following clinical trail about A Study of Combination or~     Sequential Treatment With PEGASYS (Peginterferon Alfa-2a) and Entecavir in Patients With~     HBeAg Positive Chronic Hepatitis B(OSST trail),A Real-World Study of Pegylated Interferon In~     Nucleoside-treated Patients With Chronic Hepatitis B (COST study), Combination Therapy With~     Interferon Plus Interleukin 2 and Hepatitis B Vaccine in Chronic Hepatitis B~     Patients(Endeavor study),A Prospective Clinical Trial in Chronic Hepatitis B Patients~     Nucleotide Analogues Experienced (Anchor A Study),Sequential/Combination Therapy in~     Nucleoside or Nucleotide Analogue (NA)-Suppressed Chronic Hepatitis B Patients (NPGV~     study).We plan to compare the HBsAg negative rate and maintenance rate,the occurrence of~     liver cirrhosis and the occurrence rate of hepatocellular carcinoma(HCC) related to hepatitis~     B virus(HBV) within five years between interferon group (including interferon alone or~     interferon combined with other drugs) and nucleoside analogues.Patients were divided into two~     groups based on whether they received interferon or not.~   "
15966|NCT03357952|"~     The main purpose of this study is to assess the safety of the combination of JNJ-63723283 and~     daratumumab (Part 1); to compare the overall response rate (ORR) in participants treated with~     JNJ-63723283 in combination with daratumumab versus daratumumab alone (Part 2); and to~     compare progression-free survival (PFS) in participants treated with JNJ-63723283 in~     combination with daratumumab versus daratumumab alone (Part 3).~   "
21954|NCT03279653|"~     Main proposed benefit of sleeve gastrectomy is loss of ghrelin secreting tissue. Some studies~     express that ghrelin augment pancreatic regeneration. Therefore we hypothesized that with~     sleeve gastrectomy it may result with pancreatic insufficiency.~   "
15955|NCT03358095|"~     Surgical resection is the only option for cure for patients with a resectable tumor located~     at the head of the pancreas. At the time of diagnosis, these patients often suffer from~     jaundice. Studies have suggested, that jaundice might increase the risk of developing a~     serious postoperative complication. Preoperative biliary drainage is widely used, because it~     is considered to improve the surgical outcome and reduce the amount of postoperative~     complications. There are also studies that suggest the opposite. In these studies the overall~     complication rate with patients who underwent preoperative biliary drainage was higher than~     in the patients who were operated right away. A significant amount of these complications~     were related to the biliary drainage process itself. However, preoperative biliary~     decompression is widely used in many centers as many surgical centers don't possess the~     needed resources to arrange early surgery. The benefits and risks of this procedure remain~     unclear. This multicenter trial aims to compare the surgical outcome and the rate of serious~     complications in patients who proceed directly to early surgery and patients who have~     preoperative biliary drainage.~   "
15956|NCT03358082|"~     The study will evaluate the effectiveness of Tacrolimus 0.03% ointment monotherapy in~     patients with vitiligo. Patients will be treated for 6 months and followed for 3 months after~     treatment. All types of vitiligo will be included.~   "
15957|NCT03358069|"~     Emergence agitation (EA) is one of the unpleasant symptoms after general anesthesia. The~     patient can be irritable, uncooperate, cry, moan and combative behaviors. Sometimes the~     patient may need to be thrashed to prevent physical harm. The mechanism of EA is still~     unknown. EA is usually self limiting within 45 to 60 minutes after wake up from anesthesia.~     The incidence of EA is much higher in pediatric group when compared with adult. In some~     centre the incidence of EA can be up to 67 % depends on anesthesia technique, race, and~     child's temperament. Kain et al, reported that the patient who had marked EA tended to have~     post operative maladaptive behaviors. These maladaptive behaviors such as insomnia, eating~     disturbance, aggressive behavior and even developmental regression can be happen until one~     year after anesthesia.~      From the previous study, reported that fast emergence was associated with a high incidence of~     agitation.~      This prospective observation study is conducted to determine that emergence time has any~     effect on EA or not. The authors use process electroencephalogram (entropy) to monitor~     emergence time which defined as the time which state entropy level over sixty to eighty.~     Meanwhile, we will evaluate the emergence time by the conventional method which used the time~     from ceasing anesthesia to the time of eye opening by normal voice stimuli.~      The primary outcome of this study is the correlation between emergence time (both from~     Process EEG and clinical presentation) and incidence of emergence agitation. Two secondary~     outcomes will be measured. Firstly, the correlation between emergence time and postoperative~     behavioral changes. Secondly, the relationship between entropy monitoring and clinical~     symptoms.~   "
15958|NCT03358056|"~     Background: In the last 30 years mindfulness-based approaches have been extensively used for~     a variety of mental disorders, including affective disorders characterized by emotional~     instability. Mindfulness based cognitive therapy (MBCT) is an 8-week intervention that~     combines mindfulness practices with cognitive behavioural therapy. Although changes in~     emotional processing have been postulated as one of mindfulness mechanisms of action, the~     effects of mindfulness-based programs on objective tasks of emotional processing have been~     poorly studied.~      Objective: To explore the effects of mindfulness-based cognitive therapy (MBCT) on emotional~     processing in a sample of individuals with emotional instability attended in a mental-health~     public service.~      Methods: The sample (n = 30) will be recruited from public mental-health outpatient centers~     in Barcelona, Spain. Inclusion criteria: 1) high emotional instability defined as scores~     above 96 on the Difficulties in Emotion Regulation Scale (DERS), 2) age between 18 and 65~     years, 4) no prior experience with mindfulness/meditation. Exclusion criteria: 1) risk of~     suicide (attempted suicide in the last year or current suicidal ideation). Psychotropic~     medication will be permitted, as long as there are no changes in dose/type during the study~     period.~      Measures Diagnostic measures (MINI, DERS, CGI) and a complete medical register will be~     collected prior inclusion in the study. Additional measures on personality (ZKPQ) and~     temperament (Temps-A) will be collected as well.~      Primary outcome:~      Emotional processing task: Participants will complete the FERT task at two time points:~     baseline (pre-treatment) and 8 weeks (post-treatment).~      Secondary outcomes:~      In addition, participants will complete the following assessments (pre-and-post- treatment):~        -  Depressive Symptoms (QIDS-16)~        -  Anxiety Symptoms (STAI)~        -  Mindfulness (FFMQ and EQ).~      Treatment Mindfulness-based cognitive therapy (MBCT) is a manualized, 8 weeks-group-based~     training derived from mindfulness-based stress reduction (MBSR) and cognitive-behavioral~     therapy (CBT). In MBCT participants are trained in how to be more aware of their bodily~     sensations, thoughts and feelings associated with negative emotional states. Mindfulness~     exercises and cognitive-behavioral skills are practiced both during the sessions and through~     homework assignments. The program is structured in 2.30 h group sessions over 8 consecutive~     weeks.~   "
15959|NCT03358043|"~     This study is aimed to establish the epidemiological chacacteristics and clinical outcomes of~     mechanically ventilated patients with acute hypoxemic respiratory failure admitted in a~     network of hospitals from Wales (U.K.).~   "
15960|NCT03358030|"~     Evaluation of safety, tolerability, Pharmacokinetics and Pharmacodynamics of ISIS 416858 for~     up to 204 patients with end-stage renal disease (ESRD) receiving chronic hemodialysis.~   "
15961|NCT03358017|"~     Recent evidences suggest that zoledronate, one of the most used bisphosphonates (BPs) in the~     clinical setting for the prevention and treatment of bone metastasis in cancer patients, may~     have antitumor activity in early breast cancer. The ABCSG-12 clinical trial have reported~     improved Disease Free Survival (DFS) and Overall Survival (OS) in mostly chemotherapy naive~     premenopausal patients after a 3-years of treatment with zoledronate (zol) and~     ovarian-suppression therapy. The ZO-FAST study showed better DFS for immediate use of zol in~     postmenopausal patients receiving adjuvant hormonal treatment. Preliminary evidences support~     the role of zoledronate also in neoadjuvant setting reporting better responses in cases of~     treatment with zol and chemotherapy (cht) compared with cht alone. The anticancer mechanism~     of action of BPs still remains not well understood. Basically, BPs are mevalonate (MVA)~     pathway inhibitors and one of the most intriguing hypothesis supporting their anticancer~     activity relies on the modulation of the mevalonate downstream metabolism. Selected cancer~     subtypes may present a more pronounced mevalonate activity able to confer an aggressive~     phenotype. It has been shown that a mutant p53 acts as promoter of MVA upregulation. One of~     the most important biological implications of MVA pathway upregulation in cancer cells is the~     aberrant activation of the Hippo pathway, a molecular axis with a central role in~     carcinogenesis. Two Hippo pathway related transcriptional coactivators, YAP and TAZ, promote~     tissue proliferation and the self-renewal of normal and cancer stem cells, and incite~     metastasis. Due to the strong interplay between the MVA and Hippo pathways, the modulation of~     MVA axis has deep impact on the function of YAP/TAZ as transcriptional regulators of tumour~     growth. These findings implicate the mevalonate pathway as a therapeutic target for selected~     tumors with up-regulation of these pathways.~      Preclinical and clinical evidences suggest that BPs are able to interfere with YAP/TAZ~     expression, via MVA pathway. This kind of activity may be part of the mechanism of action of~     BPs as antitumor drugs. Others medications are able to modulate the MVA pathway. Statins, a~     first-class of lipid-lowering medications that inhibit the enzyme HMG-CoA reductase, inhibit~     the sterol biosynthesis via the mevalonate pathway. A possible anti-tumor effect of statins~     can be predicted with the same mechanism of action described for BPs, through the~     interference with the MVA axis. Actually, the anti-tumor activity of statins have been~     investigated in different retrospective analyses. In breast cancer a more robust signal has~     been retrospectively reported and prospective studies have enquired the exquisite antitumor~     activity of statins in pre-operative breast cancer setting. From above, the clinical trial~     herein proposed aims to investigate the antitumoral clinical activity of zoledronate (zol)~     and statins (atorvastatin) combination, in patients receiving neoadjuvant chemotherapy for~     triple-negative breast cancer (TNBC). The primary objective of the study is to address in~     patients with TNBC the antitumor activity of pre-operative standard chemotherapy associated~     or not with zoledronate (zol) and atorvastatin measured through its effect on YAP and TAZ~     immunochemistry (IHC) expressions, which are considered co-primary objectives.~      The primary clinical objective is to assess the anti-tumor activity of the combination of~     neoadjuvant standard cht associated with zol and atorvastatin, measured by the proportion of~     pCR obtained after neoadjuvant treatment in patients with TNBC.~      Secondary objectives are: 1) to evaluate the anti-tumor activity of pre-operative standard~     chemotherapy associated or not with zol and atorvastatin according to high/low p53 levels 2)~     to address the efficacy of neoadjuvant cht associated or not with zol/atorvastatin combo in~     terms of disease free survival and overall survival); 3) to study the safety profile of study~     treatments; 4) to investigate the treatment modulation of YAP and TAZ gene expression~     (RNA-Seq) in tumor tissues collected at the time of core-biopsy and definitive surgery; 5) to~     address the modulation of Ki67expression by IHC in the FFPE diagnostic core biopsy tumor~     block and in the tumor tissue collected at surgery.~      Patients fulfilling the eligibility criteria will be randomized to receive standard~     anthracyclines/taxanes based neoadjuvant cht (ARM A) or the combination of zol and~     atorvastatin associated with the above mentioned neoadjuvant cht (ARM B).~   "
15962|NCT03358004|"~     TNBC, defined by the lack of immunohistochemical staining for oestrogen receptors,~     progesterone receptors, and lack of overexpression or amplification of HER2/neu, has an~     aggressive biological behaviour, marked by increased risk of recurrence and poorer survival~     compared with hormone receptor-positive subtypes.~      The key points for the rationale of the present study are:~        1. Despite different efforts for improving the outcome of TNBC patients, the median~          distant-disease free interval for relapsed triple-negative breast cancer is about 1-2~          years, and the median survival for metastatic TNBC is approximately one year.~        2. International guidelines currently recommend polychemotherapy instead of sequential~          single agents as first-line treatment in this subgroup of patients, but no data is~          available at the moment regarding the optimal duration of chemotherapy.~        3. There is growing evidence to suggest that platinum-based therapy may have a role in both~          advanced and early-stage TNBC, though results are not definitive. Three randomized phase~          II neoadjuvant trials have been reported, two of which demonstrated an improvement in~          pathological complete response (pCR) rates when carboplatin is added to anthracycline~          and taxane-based chemotherapy, though this pCR improvement came at the cost of an~          increase in toxicity. Definitive results from phase III trials demonstrating improvement~          in long-term outcomes such as event-free and overall survival are not yet available, and~          it remains unclear how to optimally incorporate platinums into neoadjuvant therapy, as~          toxicity is enhanced when platinum is incorporated as an add-on to standard combination~          chemotherapy backbones. A randomized phase III trial comparing cisplatin plus~          gemcitabine to paclitaxel plus gemcitabine has been published recently. After a median~          follow-up of 16.3 months in the cisplatin plus gemcitabine group and 15.9 months in the~          paclitaxel plus gemcitabine group, the hazard ratio for progression-free survival was~          0.692 (95% CI 0•523-0•915; pnon-inferiority<0•0001, superiority=0•009. Thus cisplatin~          plus gemcitabine was both non-inferior to and superior to paclitaxel plus gemcitabine.~          Median progression-free survival was 7.7 months (95% CI 6.2-9.3) in the cisplatin plus~          gemcitabine group and 6.5 months (5.8-7.2) in the paclitaxel plus gemcitabine group.~        4. In both early and advanced disease settings, response rates appear to be influenced by~          germ line BRCA1 and BRCA2 mutation status, and BRCA1 and BRCA2 mutation status has~          emerged as an important potential biomarker for platinum therapy. Outside of the BRCA~          mutant setting, there is certainly good reason to believe that there are patients with~          sporadic TNBC who stand to benefit greatly from a platinum-based approach. Tumour-based~          assays that detect levels of genomic scarring caused by the accumulation of DNA damage~          over time secondary to underlying DNA repair defects, such as the Myriad HRD assay, have~          potential to identify non carriers of BRCA1 or BRCA2 mutations with BRCA-like breast~          cancer, who may respond to DNA repair- targeted treatment strategies, such as platinum~          agents.~      One of the most promising way to improve clinical outcome in poor-risk patients is~     represented by maintenance therapy with a non-cross resistant regimen after an induction~     treatment, until disease progression. Nevertheless, the main limit to such a strategy is the~     choice of chemotherapy agents, considering that patients could be treated for a long period~     of time The results of the VICTOR-1 study was recently published, the aim of this study was~     the determination of the maximum tolerated dose of oral metronomic schedule of vinorelbine~     (VNR) in combination with fixed doses of capecitabine (CAPE), as well as to confirm the~     safety profile of the combination in a cohort of HER2-negative metastatic breast cancer~     patients. The results demonstrated a lower incidence of hematological grade 3-4 adverse~     events (1.1%), in comparison to what published in other series, using the standard schedules~     of the two drugs. The present study is designed to select the best arm between oral~     metronomic schedule of vinorelbine (VNR) and combination of oral metronomic schedule VNR with~     fixed doses of capecitabine (CAPE) as maintenance therapy in advanced TNBC patients~     responders after an induction treatment.~   "
15963|NCT03357991|"~     This study evaluates the positive and negative predictive value of E6/E7 mRNA expression for~     anal HSIL and its capacity to predict incident HSIL in HIV + MSM. We also analyse the~     cost-effectiveness of this new screening strategy. It is an ambispective study with 355~     participants and a follow-up period of 2 to 5 years.~   "
15964|NCT03357978|"~     Ataxia telangiectasia (A-T) is a rare devastating human recessive disorder characterized by~     progressive cerebellar ataxia, immunodeficiency, chromosomal instability and cancer~     susceptibility. The immunodeficiency is expressed by recurring infections. It's characterised~     by decreased lymphocytes data as well as lack of immunglobulin A, immunglobulin G subclasses~     and specific antibodies against pneumococcus. Aim of the present clinical trial is to~     investigate frequency-, intensity- and duration of the infections as well as changes oft~     immune status, dimension of liver disease and tumor risk in patients with A-T, with and~     without immunoglobulin G substitution therapy. Transient elastography (FibroScan) will be~     performed in order to measure liver stiffness as an indication of fatty liver and liver~     fibrosis. A bioelectrical impedance analysis (BIA) is conducted to investigate the exact body~     composition. Ataxia Score is determined to define neurological problems. Every subject~     receives a diary to compile symptoms of infection.~   "
15965|NCT03357965|"~     Maternal bonding was described as a qualitative change in the relationship of a mother with~     her infant. By this study, the investigators aimed to investigate the mother-infant bonding~     and the factors affecting it, from the point of the family practice, which is responsible for~     the healthcare of all family members from the fetus to the eldest individual in a family.~   "
15967|NCT03357939|"~     This healthy male volunteers study will evaluate 148 subjects who will receive a single~     sub-cutaneous dose of HLX03 （a monoclonal antibody against TNF-a, 40 mg/ 0.8 mL） or~     Adalimumab(Humira,China spourced,40 mg/0.8 mL injection with a single-use prefilled syringe).~     This study will involve sampling,pharmacokinetics, safety, tolerability and immunogenicity~     evaluation of drug levels following administration of HLX03 and the licensed adalimumab~     products.~   "
15968|NCT03357926|"~     Atrial fibrillation (AF) is associated with a five-fold increased risk of cerebrovascular~     stroke. While the risk of stroke in patients with known AF can be calculated via AF stroke~     prediction risk scores, the prediction of AF occurrence per se in individual patients remains~     difficult.~      We will recruit 250 patients with an implanted dual-chamber Pacemaker (PM) or an implantable~     cardioverter Defibrillator (ICD) with atrial lead to ensure continuous rhythm monitoring~     during follow up. At baseline, we will gather clinical and device data of patients. For AF~     prediction based on surface Electrocardiography (ECG), 24-h Holter ECG monitoring will be~     performed. After 6 months, we will assess the occurrence of AF during the study period via~     interrogation of PM/ICD. The resulting data will be used to develop algorithms including~     clinical, device and ECG data for prediction of the development of AF in individual patients.~     If possible, we will develop a risk score of high accuracy by combination of demographical,~     clinical and technical parameters of device patients. The resulting risk score could~     potentially help to facilitate the decision if anticoagulation is necessary in patients with~     either risk of AF or embolic stroke of unknown origin. Furthermore, Hayn et al. (AIT Austrian~     Institute of Technology) are currently developing algorithms to predict the occurrence of AF~     surface ECG data. It is an additional aim of this project to support the development of this~     algorithm in pacemaker and ICD patients and to increase the accuracy of AF prediction with~     clinical parameters and other parameters available to patients with implanted pacemaker (PM)~     or implanted cardioverter-defibrillator (ICD).~   "
15969|NCT03357913|"~     Pulmonary transplantation is the reference treatment for chronic terminal respiratory failure~     in patients with cystic fibrosis. These are mainly bi-pulmonary transplants (cardiopulmonary~     transplants are exceptional). The annual number of pulmonary transplants in France for cystic~     fibrosis is about 90. In 2013, the transplant involves a total of more than 600 patients with~     cystic fibrosis. The average age at the time of the transplant is 28.5 years (2013 data,~     French cystic fibrosis register), compared to 58 years for patients transplanted to all~     pathologies. Cystic fibrosis accounts for 25% of adult bi-pulmonary grafts. Pediatric~     transplants are currently very rare.~      The median survival after pulmonary transplantation in cystic fibrosis is currently 8.5 years~     (and 10 years when considering patients surviving 3 months, ie excluding early mortality).~     Cystic fibrosis is the pathology associated with better survival after pulmonary~     transplantation given the young age of patients (28.5 years on average).~      The non-respiratory comorbidities associated with transplantation, all underlying pathologies~     combined, and referenced in the Registry of the International Society for Heart and Lung~     Transplantation (ISHLT) are: hypertension, diabetes, renal insufficiency, Dyslipidemia,~     cancers. Their frequency increases with the survival time of transplanted patients. Cystic~     fibrosis is associated with non-respiratory comorbidities, the frequency of which increases~     with age - diabetes, osteoporosis, renal insufficiency, hepatopathy, neoplastic pathologies -~     and may become worse after transplantation.~      The main objective is to estimate the incidence of non-respiratory co-morbidities after lung~     transplantation in the cohort of patients with cystic fibrosis grafted in the Rhône-Alpes~     region.~   "
15970|NCT03357900|"~     Automated titration of propofol and remifentanil guided by the bispectral index (BIS) has~     been used for numerous surgical procedures. Orthotopic liver transplantation (OLT) uniquely~     combines major volaemic changes, an anhepatic phase, and ischaemia-reperfusion syndrome. We~     assessed the behaviour of this automated controller during OLT~   "
15971|NCT03357887|"~     To look at the prognostic value of new biomarkers in CSF and serum for characterisation of~     multiple sclerosis~   "
15972|NCT03357874|"~     Ticagrelor is a potent and fast-acting P2Y12-ADP receptor antagonist recommended as~     first-line agent in ACS (2). This drug was associated with a 20% relative reduction in the~     rate of MACE in ACS patients undergoing PCI compared to clopidogrel. This benefit came~     without any increase in major bleedings compared to clopidogrel (6).~      In the PLATO trial, a limited number of kidney failure patients were included (21%) and~     patients with terminal CKD were excluded. A sub-group analysis focused on CKD patients was~     performed. Only 214 patients with CKD below stage 4 (creatinine clearance <30 ml/min) were~     included (7). No patient with terminal CKD or undergoing chronic hemodialysis was included.~      Of importance, kidney function impairment is frequent and affects up-to 40 % of ACS patients.~     In addition, CKD is a powerful independent predictor of ischemic complications during ACS~     (8-9).Indeed, CKD patients have a very high risk of MACE following ACS with an odd ratio~     between 2 and 3 compared to patients with normal kidney function and event rates above 40% at~     one year follow-up (8-13). Of importance these patients more often have high on-clopidogrel~     platelet reactivity which was strongly associated with a worse clinical outcome (3,14-16). In~     CKD patients HTPR was associated with death after PCI (15). Accordingly ticagrelor which~     overcomes these limitations of clopidogrel could be associated with a major clinical benefit~     in severe or terminal CKD patients.~      Most of ticagrelor and is active metabolites are excreted through the feces. Preclinical data~     suggested that renal impairment had little effect on systemic exposure to the~     drug(EMEA/H/C/1241 (28)). Recent pharmacodynamic and kinetic studies confirmed these~     preclinical data on the safety of ticagrelor in severe and end-stage CKD (17-19).~      Therefore based on the rational above and to the lack of relevant clinical data, the optimal~     P2Y12-ADP receptor antagonist for patients with stage 4 and 5 and patients undergoing chronic~     dialysis remains undetermined in ACS treated with PCI.~      We aimed to compare the clinical efficacy ticagrelor and clopidogrel in patients with stage 4~     and 5 or on chronic hemodialysis undergoing PCI for ACS.~   "
15973|NCT03357861|"~     This work aims to describe the characteristics and methods of management of patients~     suffering from a solid tumor treated with immunotherapy admitted to intensive care.~   "
15974|NCT03357848|"~     The role of nutritional therapy (TN) in the surgical patient is well described in the~     literature and is associated with reductions in postoperative complications, length of~     hospital stay, and mortality. Adequate determination of caloric and protein requirements is~     an essential step in the TN institution, avoiding hypoalimentation and hyperalimentation.~     Thus, it is essential to understand the changes in energy expenditure after surgery and its~     relation with nutritional status. In addition, little is known about the effect of~     nutritional therapy and caloric adequacy on parameters such as phase angle and dynamometry.~     Thus, the objective of this study is to evaluate the changes in energy expenditure after~     major abdominal surgeries and to evaluate the phase angle and dynamometry as possible markers~     of nutritional therapy. Energy expenditure will be assessed by indirect calorimetry.~     Functionality will be assessed by means of dynamometry and 6-minute walk test. Nutritional~     diagnosis will be given through subjective global assessment. Energy and protein intake will~     be monitored and registered daily. Phase angle will be obtained by performing bioelectrical~     impedance.~   "
15977|NCT03357809|"~     Currently patients with gastroesophageal reflux disease (GERD) are treated with proton pump~     inhibitors (PPIs). This long-term PPI treatment would likely increase the risk of pulmonary~     and digestive infections and would not prevent evolution to adenocarcinoma of Barrett's~     Esophagus. Surgical fundoplication is generally recommended when symptoms are poorly~     controlled with PPIs and considered as standard treatment despite celioscopy risk. A variety~     of endoscopic techniques for the treatment of GERD has been proposed to obtain non-surgical~     control. These endoscopic techniques aim to bring the tissues closer to the Œsogastric (JOG)~     junction. But a low response rate has been demonstrated with these techniques.~      H. Inoue (inventor of the anti-reflux mucosectomy 20 years ago) and his team postulated that~     the reflux symptoms would be reduced by creating a relative restriction of gastric cardia.~     The healing of the mucosectomy zone led to restriction of gastric cardia. This observation~     suggested that ARMS could represent an effective anti-reflux procedure with the advantage~     that no prostheses would be left in situ.~      Few studies have evaluated this new endoscopic technique. The purpose of this study is to~     evaluate the feasibility and safety of gastric mucosectomy for patients with GERD resistant~     to medical treatment or requiring long-term maintenance medical treatment.~   "
15978|NCT03357796|"~     The objective of this study is to evaluate relative bioavailability between 80 mg LY03005~     oral tablets and 50 mg Pristiq® oral tablets after a single dose of each drug in a cross-over~     2-period design under fasting condition in healthy subjects between 18 and 50 years of age.~   "
15979|NCT03357783|"~     The purpose of this study is to determine the prevalence of macroscopic deciduosis found~     randomly in Cesarean sections and the secondary objective to determine the association with~     any obstetrical complications or adverse effects.~   "
15980|NCT03357770|"~     The aim of this study was to evaluate the maximum tolerated dose of Mesenchymal Stem Cells~     (MSCs) from umbilical cord in the treatment of human knee OA~   "
15981|NCT03357757|"~     Up to 20% of all cancers may be associated with a bacterial or viral infection. In some~     instances, the infection may be one of the reasons why the cancer developed in the first~     place. One such example is infection with the human papilloma virus (HPV) and the development~     of cervical or oral cavity cancer.~      A viral infection that is chronic may not cause a person symptoms, and may be able to escape~     detection by a person's own immune system. One of the medications being studied in this~     clinical trial (Valproic acid) may be able to unmask a chronic viral infection from a~     person's own immune system, therefore making the virus susceptible to attack by the immune~     system. In this study Valproic acid is being combined with an immune therapy, Avelumab.~     Avelumab is an antibody that targets a person's own immune cells, or lymphocytes. Lymphocytes~     must be activated to fight infections or cancer, but after activation they are deactivated.~     Avelumab prevents the deactivation of a lymphocyte, in effect turning off the off-switch.~     This leads to a re-energizing of a person's immune system, hopefully leading to an attack by~     the immune system on a person's cancer.~      Avelumab is known to be an effective treatment for a variety of cancers, although it has not~     yet been tested in all cancers. By combining Valproic acid, a treatment which targets the~     virus that contributed to the development of this type of cancer with Avelumab the~     investigators hope to enhance the ability of Avelumab to restore the body's own immune~     defense against the cancer.~   "
15982|NCT03357744|"~     Breast cancer is the most prevalent cancer among women worldwide [1]. 5 years after~     diagnosis, up to 87% survives. A substantial group of these survivors report reduced~     physical, psycho social and cognitive functioning. Therefore, it is increasingly important to~     screen for distress, both during and after treatment. The Distress Barometer (DB) is a valid,~     short screening instrument, used to detect elevated levels of distress in patients with~     cancer. It can be used either in a self-report questionnaire or in an interview format.~      Although the DB is used in different ways, it remains unclear whether both assessment methods~     would generate similar results, and which format is most suitable to represent the actual~     level of distress. Existing literature on the DB lacks a systematic description of the~     relationship between the method of assessment and the patients' responses. This study~     questions whether the written and interview variants of the DB reveal different results in~     the same patients with breast cancer.~   "
15983|NCT03357731|"~     The purpose of this study is to evaluate the effects of BMS-986231 on systolic and diastolic~     parameters in patients with heart failure and low ejection fraction.~   "
15984|NCT03357718|"~     The aim of this study was to compare the effect of 2 µg/kg of oral dexmedetomidine (DEX) and~     0.5 mg/kg dormicum as premedication among children undergoing dental procedures.~   "
15985|NCT03357705|"~     The aim of the present study is to evaluate the effectiveness of different alveolar~     preservation procedures performed at the time of extraction of the first or second upper~     molar in avoiding a maxillary sinus elevation or at least limiting the size, to allow the~     insertion of dental implants. The residual bone height will be radiographically evaluated on~     the sinus sinus floor at the time of extraction and after 6 months by comparing the cases~     where alveolar preservation is performed using a nanocrystalline synthetic hydroxyapatite~     graft (group A) with cases where the procedure of alveolar preservation is performed using~     bovine collagen sponge (group B).~   "
15986|NCT03357692|"~     The objective of this observational study is the radiographic evaluation of marginal bone~     remodeling after surgical implant insertion in an immediate loading all-on-four technique~     with trans-sinusal titanium implants, correlating the gingival thickness and the height of~     the implant prosthetic stump with the proportion of the abovementioned marginal bone~     remodeling.~   "
15994|NCT03357588|"~     The ITREMA trial is an open-label randomized controlled trial (RCT) in which HIV-1 infected~     patients initiating first-line ART and already on first-line ART will be enrolled. Enrollment~     will continue until 600 patients have been randomized. Patients initiating ART will be~     randomized after six months of ART and patients already on ART will be randomized at 6 months~     after the last viral load measurement. Patients in both arms will receive study visits every~     three months for a total follow-up duration of 18 months after randomization to either of two~     study arms. The control arm will receive standard of care HIV-1 treatment monitoring during~     first-line ART in accordance with South African National Department of Health (NDoH)~     guidelines. The intervention arm will receive intensified treatment monitoring during~     first-line ART according to the treatment monitoring strategy under investigation.~   "
15987|NCT03357679|"~     Positioning during the process of tracheal intubation is critical, as optimal positioning can~     greatly facilitate successful intubation. Many complications can occur as a result of failed~     intubation, ranging from airway injury, lack of oxygen, with even deaths. Today, the most~     popular positioning of patients for intubation is in the sniffing position. There is~     however evidence to support that intubation in the bed-up-head-elevated position may be~     better. In today's technological age, video assisted laryngoscopy (Laryngoscopy is the~     process of visualizing the vocal cords prior to intubation), a new method where the~     anaesthetist intubates a patient via aid of an image guided view of the airway, is~     increasingly popular due to its reliability and superiority to normal intubation. However, it~     is not widely available, and may suffer from technical breakdowns. The Glidescope is one~     example of a video laryngoscope, and has been widely researched in the medical literature. In~     this study, the investigators wish to investigate whether intubation in the~     bed-up-head-elevated position will be as good as, if not better than Glidescope assisted~     tracheal intubation, in patients undergoing elective surgery and planned for general~     anaesthesia.~   "
15988|NCT03357666|"~     The objective of the study is to confirm the pharmacological mechanism and evaluate the~     efficacy and safety after HUDC-VT administration compared to placebo in patients with~     bacterial vaginosis.~      Vaginitis in adult women is extremely common and it often results in marked suffering.~     Epidemiologic studies indicate the high prevalence of vaginitis and the large number of~     causes in US.~      The broad-spectrum antibiotics such as metronidazole have been used as a treatment of~     vaginitis.However, it is not desirable using of these antibiotics caused appearance of~     resistant bacterium and killing normal bacterium including lactobacillus.~      In addition, it has been reported that long term treatment of antibiotics can be caused body~     toxicity through absolution by vagina.~      The product, HUDC_VT, is a effective and safe vaginal tablet composed glucose and sodium~     chloride for treatment of vaginitis by preserving healthy condition in vagina.~   "
15989|NCT03357653|"~     Immunoglobulin A nephropathy (IgAN) is the most common glomerulonephritis worldwide. IgAN is~     progressive, particularly when patients have a significant proteinuria (proteinuria >1g/g~     creatinine), impaired kidney function, or elevated blood pressure. In 10 years, nearly 20-40%~     of these IgAN patients progress to end-stage renal disease (ESRD). Early IgAN is tentatively~     defined when proteinuria is insignificant and kidney function and blood pressure are normal.~     Patients with early IgAN rarely progress to ESRD. However, 30-40% of patients with early IgAN~     ultimately developed a significant proteinuria and hypertension in 10 years. Therefore,~     earlier intervention may be needed if it can prevent the development of a significant~     proteinuria and hypertension. Since angiotensin ll receptor blocker (ARB) is drug of choice~     in reducing proteinuria and controlling blood pressure, the investigators hypothesized that~     early introduction of ARB may be beneficial in preventing the significant proteinuria~     development in early IgAN patients. To prove the hypothesis, the investigators plan the~     current interventional study.~   "
15990|NCT03357640|"~     Women will be managed by either of the two modalities and will be followed up by transvaginal~     ultrasound monthly for three successive months to evaluate the size and location of the~     functional ovarian cyst (follicular), to compare the effect of different modalities of~     management whether remission, regression, progression or persistence of functional ovarian~     cyst.~      The women will be assigned randomly to either study group to take oral contraceptive pills or~     to control group to take placebo. The 2 groups will be treated and followed up equally. Oral~     contraceptive pills will be given to the study group as follow:~      The women will receive one package of oral contraception (Cilest containing norgestimate 250~     microgram + ethinyl estradiol 35 microgram) and will be counseled about how to take oral~     contraception and informed of possible side effects. They also will receive a diary card for~     recording oral contraception intake to be returned to the physician on the next period. An~     appointment for the women in this group will be scheduled at one month of treatment for the~     second ultra-sonography. If the ovarian cyst does not show remission, the women will continue~     the same treatment and will follow up in another month by transvaginal ultra-sound. If the~     ovarian cyst still persists or progresses at the second month, the women will be followed up~     for third month. All results of the two groups will be compared. Data will be collected,~     tabulated according to the standard statistical method.~   "
15991|NCT03357627|"~     The purpose of this study is to determine the maximum tolerated dose (MTD) and/or recommended~     phase 2 dose (RP2D) of TAK-659 and venetoclax when administered in combination in~     participants with non-Hodgkin lymphoma (NHL) relapsed and/or refractory after at least 1~     prior line of therapy and to evaluate safety and tolerability of TAK-659 and venetoclax when~     administered in combination.~   "
15992|NCT03357614|"~     This is a prospective, phase 3, double-blind, multicenter, randomized study to compare the~     efficacy and safety of sulopenem followed by sulopenem etzadroxil with probenecid versus~     ertapenem followed by ciprofloxacin for the treatment of complicated urinary tract infections~     in adults.~   "
15993|NCT03357601|"~     This study examines whether high intensity interval training (HIIT) or moderate, continuous~     endurance exercise training (MCEET) results in greater program adherence when matched for~     session time. Body composition and endurance capacity will also be measured to identify any~     significant changes among two exercise groups. It is hypothesized that HIIT will result in~     greater program adherence as well as greater improvements in body composition and endurance~     capacity. Both exercise groups will complete 20 minutes sessions (which include exercise)~     three times per week for five week. The first week will be supervised by study investigators~     while the remainder of the study will be unsupervised in order to examine how free-living~     individuals adhere to two exercise programs. There will be no attempt to restrict food intake~     during the exercise intervention. Body composition will be measured by densitometry [body~     mass/body volume] using a BodPod. Endurance capacity will be assessed using a mile run. Two~     validated questionnaires [Physical activity enjoyment scale and Exercise adherence ratings~     scale] as well as heart rate data (recorded before, during and after each training sessions)~     will be used to confirm exercise adherence. These data may help us determine the optimal type~     of exercise program to maintain healthy body composition.~   "
15995|NCT03357575|"~     The aim of this study was to evaluate the efficacy and safety of Mesenchymal Stem Cells~     (MSCs) from adipose anticular injection in comparison with hyaluronic acid anticular~     injection in the treatment of human knee osteoarthritis(OA).~   "
15997|NCT03357549|"~     Breastfeeding is the ideal feeding for the newborn. The success of the initiation and~     maintenance of breastfeeding can be influenced by different factors, as breastfeeding~     self-efficacy. Brief Motivational Intervention (BMI) is a form of collaborative guidance,~     person-centered approach aimed at strengthening the motivation to adopting healthy~     initiatives and can increase the self-efficacy.~      The hypothesis is that an BMI to promote breastfeeding, during immediate postpartum plus~     telephone support at the first and third postpartum months, will significant increase in the~     adherence and duration of breastfeeding compared with the habitual education action applied~     at the same time. Also, the BMI will increase the breastfeeding self-efficacy of the~     particpants, and this breastfeeding self-efficacy will be a mediator of the effect between~     the IMB and the breastfeeding duration.~      The general self-efficacy of the participants will change the size of the effect of BMI.~   "
15998|NCT03357536|"~     Listeriosis is a rare, severe foodborne infection, responsible for severe invasive~     infections. It occurs in the great majority of cases in elderly patients and / or patients~     with comorbidities, with a deficit of innate or cellular immunity. Pregnancy is also a risk~     factor.~      The Multicentric Observational NAtional Analysis of Listeriosis and Listeria (MONALISA) is an~     ongoing national case-control prospective study on listeriosis implemented since 2009 to~     study risk and prognosis factors for listeriosis. In this cohort, which enrolled 902 patients~     on 1 August 2014, 7% of patients with neurolisteriosis are under 40 years of age and have no~     identified risk factor. Genetic susceptibility is suspected in these patients. Genetic~     susceptibility could also explain the inconstant development of a neurolisteriosis or fetal~     infection, as well as the particular severity of some infections (death, foetal loss,~     neurological sequelae).~      The aim of the study is to identify genetic susceptibility to Listeriosis.~   "
15999|NCT03357523|"~     The objective of the current study is to investigate the hemodynamic changes in the~     peripheral microcirculation system as a response to various changes, using noninvasive~     thermography and laser doppler~   "
16000|NCT03357510|"~     The purpose of this study is to determine whether single doses of the prebiotic~     galacto-oligosaccharide (GOS) added to iron-fortified meals with micronutrient powders~     increase iron absorption compared to a 3 weeks pre-feeding of GOS.~   "
16001|NCT03357497|"~     Early mobilization is an important part of Enhanced Recovery Programs (ERP)in colorectal~     surgery. The aim of this randomized controlled trial is to investigate the impact of very~     early mobilization, starting within 1 hour after surgery, on further mobilization within an~     existing Enhanced Recovery Program.~   "
16002|NCT03357484|"~     The purpose of this study was to evaluate the influence of leukocyte- and platelet-rich~     fibrin (L-PRF) on impacted mandibular third molar (IMTM) extraction wound healing, patient~     postoperative discomfort, and incidence of alveolar osteitis (AO).~      Thirty patients (18 female, 12 male) who met the inclusion criteria for this split-mouth~     study underwent bilateral IMTM surgical extractions. Following extraction, randomization was~     done. One socket received L-PRF, and the other socket served as a regular blood clot control.~     Postoperatively, the soft tissue healing index (HI), pain according to visual analog scale~     (VAS), facial swelling using a horizontal and vertical guide, and incidence of AO were~     evaluated 1, 3, 7, and 14 days after surgery.~   "
16003|NCT03357471|"~     The purpose of the study is to evaluate the ability of subjects who are already prescribed~     Certolizumab Pergol therapy and have been self injecting with prefilled syringes for at least~     the previous three months, to safely and effectively self-inject Certolizumab Pegol (CZP)~     using the e-Device and to evaluate the post-use structural integrity of used devices and~     cassettes via visual examination.~   "
16004|NCT03357458|"~     The aim of this novel health services research proposal is to assess the longer-term~     outcomes, to 6 months corrected age, of an adapted Family Integrated Care (FICare) model of~     care for moderate and late preterm infants admitted to a Level II neonatal intensive care~     unit (NICU).~      This follow-up study will enroll infants at 6 months CA (± 1 month) recruited to the original~     FICare randomized controlled trial (clinicaltrials.gov ID: NCT02879799) from four level II~     NICU sites; two intervention and two control.~   "
16005|NCT03357445|"~     This is a Post Marketing Clinical Follow Up study (PMCF) on the AVANTAGE RELOAD dual mobility~     system cup.~   "
16006|NCT03357432|"~     Previous work has shown that gelatin supplementation could increase collagen synthesis in~     humans. In this study subjects consume placebo, 5 or 15 g of gelatin with a standard amount~     of vitamin C (48 mg) 1 hour before 6 minutes of jump rope exercise. The feeding and exercise~     intervention was repeated every 6 hours while the subjects were awake for three days and the~     amount of the amino terminal procollagen I peptide (PINP) was determined; a marker of~     collagen synthesis, in the blood. Consistent with the hypothesis that gelatin increases~     collagen synthesis in humans; the amount of PINP in the 15 g gelatin group was significantly~     higher than either the placebo or the 5 g groups. These data conclusively demonstrate that~     gelatin supplementation can increase exercise-induced collagen synthesis in humans.~     Hydrolyzed collagen has a similar amino acid profile, in particular with high concentrations~     of glycine, proline, hydroxyproline, and arginine. Thus, the current study aims to determine~     is the same dose of gelatin, hydrolyzed collagen and a gelatin/collagen mix, all with a~     standard dose of vitamin C effect PINP levels similarly.~   "
16007|NCT03357419|"~     The incidence of surgical site infection (SSI) infection in clean dermatologic surgery is~     very low, between 1-3%. Studies have demonstrated a much higher infection rate in skin~     excision surgeries in the lower limbs, up to 10% in most studies, and even 35.7% infection~     rate in a recent study from Australia.~      To our knowledge, there are no clinical trials demonstrating the efficacy of prophylactic~     antibiotic given prior to skin lesion excision from the lower limbs.~   "
16008|NCT03357406|"~     multi center study with randomized controlled trial design, split mouth~   "
16075|NCT03356535|"~     Hepatocellular carcinoma (HCC) is the most common form of liver cancer and its incidence is~     increasing including in regions where hepatitis infection rates are low. This trend may be~     the result of increases in 'unhealthy lifestyle' factors. The main aim of this study is to~     identify metabolic signatures associated with healthy lifestyle behaviours and to relate~     these signatures to risk of developing HCC to investigate whether the metabolites were of~     predictive utility for HCC beyond data procured from questionnaires. To address this~     question, we exploited data from a large European cohort (EPIC) which includes detailed~     questionnaire-based data as well as metabolomic data.~   "
16009|NCT03357393|"~     bronchoscopy - a randomized controlled trial (EudraCT number: 2015-005274-38, protocol~     number: BRONSE) is a phase IV single centre prospective randomized controlled trial with~     parallel groups. A total of 150 adult outpatients undergo diagnostic bronchoscopy during~     sedation and are randomized into three sedation arms (1:1:1); sedation with midazolam and~     morphine-scopolamine as premedication (clinical routine), sedation with propofol using PCS~     and morphine-scopolamine as premedication, and sedation with propofol using PCS and~     glycopyrronium bromide as premedication. The study is partially blinded, the bronchoscopist~     is blinded regarding given premedication for patients given PCS (two sedation arms). The~     hypothesis is that PCS increase the amount of patients ready for discharge, and further that~     patient characteristics affect the amount of propofol administered. The endpoints are~     primarily the amount of patients ready for discharge within 2 hours and secondary assessment~     of patient recovery and satisfaction as well as bronchoscopist evaluation and doses of~     administrated drugs. Finally safety variables are collected such as vital signs and~     interventions performed to maintain cardiovascular and respiratory stability.~   "
16010|NCT03357380|"~     This study is looking at the effect of semaglutide on subjects with nonalcoholic fatty liver~     disease.This study is comparing the change in early stages of scar tissue in the liver and~     fat deposition in the liver in people taking semaglutide and placebo (a dummy medicine).~      Participants will either get semaglutide or placebo; which treatment participants get is~     decided by chance. Semaglutide is a medicine under clinical investigation. That means that~     the medicine has not yet been approved by the authorities. Participants will need to~     self-inject medicine once daily for 72 weeks. The medicine should be injected under the skin~     in the stomach, thigh or upper arm.~      There are about 3 weeks before participants start the study medicine and 7 weeks after you~     stop it. The study will last for about 82 weeks in total.~      Participants will have 12 clinic visits, 6 phone calls and 4 visits to an MRI centre.~      The study includes MRI scans of the stomach. The MRI scans will take place at a different~     location. Participants will be excluded from the study if the study doctor thinks that there~     are risks for participants health. Women cannot take part if pregnant, breast-feeding or plan~     to become pregnant during the study period.~   "
16011|NCT03357367|"~     Prospective interventional study. The aim is to analyze the effect of usual ongoing~     treatments over microvascular cutaneous response to galvanic current applications (CIV:~     current induced vasodilatation) with tissue vitality (TiVi) system on the forearm of subjects~     referred for ultrasound investigations due to suspicion of peripheral disease. Hypothesis is~     that the use of aspirin (even at low dose) abolishes the response.~      This test could make it possible to detect the functional effects of low dose aspirin without~     using biological tests. A routine clinical application could be to use this CIV to verify~     adherence to aspirin.~   "
16012|NCT03357354|"~     Action research has been developed in this direction in order to use a tool to identify food~     disorder behavior among obese youths in their neighborhoods and social centers in vulnerable~     neighborhoods of Marseille, with the aim of a multi-professional therapeutic management~     (psychosocial support, theater) and a specialized orientation.~      This program consists of the participation of each patient recruited in collective workshops.~     A total of 60 patients considered. Our hypothesis lies in the fact that for young people to~     participate in an adapted device, taking into account the global needs of young people and~     their entourage, would limit the deleterious effects of obesity and promote the young~     person's autonomy and allow him to be a actor in the request for care.~      The project's objective is to provide support in the form of workshops with patients~     identified by the Marseille Hospitals Public Assistance Health Center as obese children and~     adolescents, in a precarious situation; to identify the presence of binge eating disorders~     and evaluate the impact of participation in these workshops on subsequent management by~     highly specialized professionals in food disorder behavior.~   "
16013|NCT03357341|"~     This is a pilot study that will evaluate the feasibility of collecting increasing amounts of~     clinical study data from subjects through sensor and web/app based methods and integrating it~     with data from their EHR to facilitate more efficient and meaningful research with acceptable~     quality. Approximately 100 subjects with asthma and 100 subjects with chronic obstructive~     pulmonary disease (COPD) will be enrolled in this prospective study. The subjects will be~     identified through integrated EHR records following which eligible subjects will receive~     study devices and training on proper use of the devices at Baseline visit. Data will be~     collected remotely from subject reports, devices and sensors over six months.~   "
16014|NCT03357328|"~     This intervention study will investigate the effect of therapy light rooms on sleep,~     circadian rhythms, mood, behavioural problems and function in nursing home (NH) patients with~     dementia.~   "
16015|NCT03357315|"~     The aim of this study is the safety and efficacy of mix vaccine to small metastases of~     sarcoma.~   "
16016|NCT03357302|"~     The question posed by this project is that of the regional estimate of the relative~     importance of the risk factors of the main pathologies. Our hypothesis is that these risk~     factors are of different relative importance in Reunion Island compared to metropolitan~     France.~   "
16017|NCT03357289|"~     The aim of this study is the safety and efficacy of mix vaccine to small metastases of kidney~     cancer.~   "
16018|NCT03357276|"~     The aim of this study is the safety and efficacy of mix vaccine to small metastases of~     colorectal cancer.~   "
16019|NCT03357263|"~     Healthy adults will be once administered GC3114A(High-dose Quadrivalent influenza vaccine) or~     GCFLU Quadrivalent Pre-filled syringe inj..~   "
16020|NCT03357250|"~     Validation of biomarkers in a human population for their ability to diagnose the severity of~     neonatal asphyxia. These biomarkers linked to asphyxia have been identified in animal studies~     and a preliminary human study.~   "
16076|NCT03356522|"~     Observational study~   "
16077|NCT03356509|"~     The study will use stress inducing tasks to determine if there are significant improvements~     in mood, chocolate cravings, and attentional bias to chocolate in overweight/obese chocolate~     abusers following rest and a bout of high intensity interval exercise.~   "
16166|NCT03355339|"~     This study evaluates the effect of binasal occlusion (BNO) glasses on balance and eye~     movement in adults with dizziness after a concussion. Participants will stand on a force~     plate while rapidly reading a series of numbers both with and without the BNO glasses. It is~     thought that the BNO glasses will improve both balance and the time to read the numbers.~   "
16021|NCT03357237|"~     Acute gastroenteritis (GEA) is an inflammation of the intestinal mucosa that clinically~     translates into an acute episode of diarrhea and vomiting and is generally associated with an~     intestinal infectious disease. It is one of the most common diseases in children and an~     important cause of morbidity and mortality worldwide. The important loss of liquids can lead~     to dehydration, acidosis and hydroelectrolitic alteration. Infants are more vulnerable to~     gastrointestinal infection and its consequences, dehydration and malnutrition.~      There is no specific treatment, so it is exclusively symptomatic~      A new type of products considered as mucoprotectors has been developed, such as gelatin~     tannate or xyloglucan, still with little data to establish recommendations on its use in the~     GEA. They would be able to reproduce in the intestine a muco-adhesive film or sheet~     protective It must be considered in this sense that mucus is the first barrier that protects~     the gastrointestinal tract against microorganisms or antigens and that bacterial invasion is~     related to the opening of narrow junctions.~      Xyloglucan was approved in Europe as a medical device IIa to restore the physiological~     functions of the intestinal wall in the form of capsules for adults and envelopes for~     children.~   "
16022|NCT03357224|"~     Trial assessing atezolizumab (anti-PD-L1) as treatment option for patients with mycosis~     fungoides/sezary syndrome having progressed under or after previous therapy~      For this study, we invite patients suffering from mycosis fungoides and Sézary syndrome who~     have progressed after initial therapy or have failed to respond to previous therapy.~      Mycosis fungoides and Sézary syndrome are cancers in which lymphocytes* become malignant~     (cancerous) and affect the skin. In mycosis fungoides, the disease is generally limited to~     the skin, and people develop flat or raised areas on their skin where the lymphocytes have~     accumulated. Sometimes even larger aggregations of lymphocytes occur in the skin or lymph~     nodes, resulting in tumors. In Sézary syndrome, the skin is often reddened or itchy, and some~     abnormal lymphocytes circulate in the blood.~      * Lymphocytes are a type of immune cells that is made in the bone marrow and is found in the~     blood. Lymphocytes have a number of roles in the immune system, including the production of~     antibodies and other substances that fight infections and other diseases.~      In standard practice, the disease will be treated with conventional chemotherapy that~     unfortunately has a limited lasting benefit. In this study, we want to see if a new treatment~     option can optimize and improve response and make benefit last as long as possible. This new~     treatment option is immunotherapy, using atezolizumab (Tecentriq).~      Immunotherapy is a cancer treatment that uses antibodies made in the laboratory from a single~     type of immune system cell. These antibodies can identify substances on cancer cells or~     normal cells that may help cancer cell grow. The antibodies attach to the substances and kill~     the cancer cells, block their growth, or keep them from spreading. Atezolizumab blocks a~     protein called PD-L1 (programmed death-ligand 1) from binding to its receptor found on the~     surface of lymphocytes. It helps to restore the immune activity of the body against the~     cancer.~      Atezolizumab is already used to treat adults with a cancer that affects the bladder and the~     urinary system, called urothelial carcinoma, and a cancer that affects the lungs, called~     non-small cell lung cancer.~      In this trial, patients will receive atezolizumab for one year unless the tumor starts~     growing again or this is not considered suitable for them anymore or they wish to stop the~     treatment.~   "
16023|NCT03357211|"~     Orthognathic surgery aims to correct jaw position taking into account esthetic and functional~     criteria (dental occlusion, lip position, breathing...). These surgeries are planned using~     clinical, radiological and dental cast data. The result of this planning are occlusal~     splints. Orthognathic surgery had improved in the last decade with 3 dimensions computerized~     tomography scan (3D CT-Scan) planning and osteosynthesis implants. However the accuracy of~     the operative results compared to the planned ones has rarely been measured.~   "
16024|NCT03357198|"~     Cough Peak Flow (CPF) seems to be an efficient tool to assess cough capacity for the~     intensive care unit (ICU) ventilated patient. CPF can be used in the ventilator weaning~     process, as reflecting the upper airways protection capacity.~      CPF requires disconnection of the patient from the ICU ventilator, supplemental material~     (handheld spirometer, antibacterial filter) and an excellent synchronization between the~     specialized caregiver and the patient.~      We aimed that CPF with the ventilator built-in flow-meter is correlated with CPF using a~     handheld flowmeter connected to the endotracheal tube.~   "
16025|NCT03357185|"~     Endarteriectomy is considered as the first line treatment of femoral bifurcation atheromatous~     lesions. Eversion technique, similar to that used for carotid bifurcation, is safe and~     possible for the majority of the femoral tripod lesions. The major advantage of the eversion~     technique is the absence of prosthetic material to be performed. However, its use has been~     scarcely evaluated in the literature to date. This work aims at evaluating the long term~     safety and the efficacy of eversion femoral technique. Surgical technique was thoroughly~     described and participants were followed up for two years by serial clinical and doppler US~     examination.~   "
16026|NCT03357172|"~     The study concerns donors and patients receiving allogeneic stem cell haematopoietic~     transplantation. The aim of the study is to analyse HSC graft content in immune effector T~     (naive, memory, activated, exhausted) and immunoregulatory cell subtypes (Tregs, iNKT, MDSC)~     and correlate the results with post-transplant immune reconstitution of those different cell~     subtypes and clinical events (graft-versus-host-disease, relapse, infections). An ancillary~     study will focus on the impact of microbiota dysbiosis on post-transplant immune response and~     regulatory cell subsets.~   "
16027|NCT03357159|"~     Investigators hypothesize that combination of ATLG with PTCy in matched or mismatched~     unrelated hematopoietic stem cell transplantation will reduce acute and chronic GVHD~     incidence. Furthermore it will allow shortening of the length of post-transplantation~     immunosuppression with calcineurin inhibitor (CNI) administration (currently administrated in~     addition to ATG as GVHD prophylaxis in daily common practice)~   "
16028|NCT03357146|"~     Purpose of the study is to examine the retinal blood flow in chronic cases of retinal artery~     occlusion with non-invasive, non-contact optical coherence tomography angiography.~   "
16029|NCT03357133|"~     After intravenous thrombolysis, the overall recanalization rate is 46%, and recclusion after~     initial recanalization occurs in 14-34%. In the MR TEA, the investigators compared the~     effects of administration of tirofiban in acute ischemic stroke patients treated with~     intravenous alteplase thrombolysis with alteplase alone.~   "
16030|NCT03357120|"~     Trial assessing the prognostic value of ctDNA mutations from samples taken sequentially in~     patients with invasive breast cancer initially treated with neoadjuvant chemotherapy and~     whose tumor is not in complete histological response.~   "
16031|NCT03357107|"~     Transoral robotic surgery is an option to treat supraglottic squamous cell carcinomas.~     Oncological outcomes 2 years after transoral robotic surgery for supraglottic laryngectomy~     were studied.~   "
16217|NCT03354676|"~     Obesity is a chronic inflammatory disorder in which leptin, adiponectin and C reactive~     protein (CRP) play an important role. This study aimed to investigate the relationship~     between markers of adiposity like leptin, adiponectin and high sensitive C reactive protein~     (hsCRP) in obese children, and to determine whether these adipokines are significant markers~     in defining metabolic syndrome in pediatric population~   "
16032|NCT03357094|"~     Lung cancer is one of the most common malignant tumors in the world and with the highest~     incidence in China. Surgery is the most effective therapeutic method for primary lung cancer.~     Accurate prediction of residual postoperative pulmonary function in patients, especially~     those with borderline pulmonary function, is crucial for proper qualification for surgery.~     According to the 3rd American College of Chest Physicians(ACCP) evidence-based clinical~     practice guideline (2013), both predictive postoperative (ppo) FEV1.0% and ppoDLCO% are~     greater than 60% predicted are required as a first standard of lobectomy for patients with~     primary lung cancer. And, according to the British Thoracic Society (BTS) guideline, patients~     with ppoFEV1.0% and ppoDLco% less than 40% have high a risk for surgery. Pulmonary~     ventilation / perfusion SPECT/CT has recently become available for prediction of lung~     function, and it can be used to forecast pulmonary function in consideration of the pulmonary~     circulation as well as effective residual lung function. Traditionally, prediction of~     postoperative lung function was based on planar method in anterior and posterior projections~     of lung scintigraphy. However, SPECT/CT enables measurement of ventilation / perfusion uptake~     in each lobe of the lungs in a three dimensional way, which may avoid underestimating~     ppoFEV1.0% and provide confidence in suggesting lobectomy or pneumonectomy.~      This experiment is intended to explore the use of Q.lung, a volume-based software to~     semi-quantitatively calculate pulmonary ventilation/perfusion functional uptake and volume by~     SPECT/CT. We hope it can get a more accurate prediction of postoperative residual pulmonary~     function to provide better management for clinical surgery.~   "
16033|NCT03357081|"~     Traumatic and non-traumatic soft tissue hematomas are frequently encountered in the acute~     care setting. The incidence of these hematomas appears to be on the rise secondary to the~     increased use of anticoagulants among older patients for a variety of medical conditions.~      The management of soft tissue hematomas depends on the accurate diagnosis of any ongoing~     bleeding as well as of identification of the injured vessel type. While the majority of cases~     can be managed conservatively, expanding hematomas leading to hemodynamic instability or~     ongoing blood loss might require embolization or surgical intervention. The mainstay~     diagnostic imaging modality is multidetector computed tomography (MDCT) with intravenous~     contrast that allows accurate assessment of hematoma size, location as well as evaluation for~     active extravasation. However, many patients cannot undergo CT imaging due to underlying~     kidney disease, allergy to contrast, or due to concerns for radiation exposure, especially in~     young age. Currently there are no alternative tests for these patients with a similarly high~     diagnostic accuracy available.~      This study intends to establish an imaging protocol and investigate the utility of~     contrast-enhanced ultrasound (CEUS) in the diagnostic work-up of soft tissue hematoma as an~     ionizing radiation-free alternative to computed tomography (CT) that can be used independent~     from the kidney function of the patient.~   "
16034|NCT03357068|"~     This study evaluates the effect of citric acid demineralization in autogenous bone blocks~     consolidation. Half of participants will receive citric acid treatment at the bone block and~     recipient site. Other half will receive no demineralization treatment.~   "
16035|NCT03357055|"~     A prospective, double blind, randomised controlled trial to evaluate the effect of ketamine~     in reducing tourniquet pain for patients undergoing lower limb surgery under spinal~     anaesthesia.~      Secondary Objective To evaluate the effect of ketamine in attenuating TIH for patients~     undergoing lower limb surgery under spinal anaesthesia.~   "
16036|NCT03357042|"~     A concussion occurs when a person receives an impact to the head. The most common persistent~     symptoms that generate from a concussion are headaches, depression, lack of balance and~     dizziness. One recommendation to alleviate persistent symptoms of concussion is rest.~     Research findings indicate that the benefit of rest is inconclusive to help individuals~     suffering from a concussion return to activities of daily living. One treatment approach in~     reducing concussion symptoms is physical exercise therapy. Research findings, however, are~     limited to treatments being administered before the symptoms are considered persistent. Based~     on this rationale, the aim of this study is to examine the effect of a physical therapy~     intervention in minimizing persistent symptoms of concussion using measures of cognition and~     brain function, mental and physical health, and driving performance. If successful, this~     physical therapy intervention may help treat persistent concussion symptoms, improving the~     quality of life and ability for individuals to function normally in their daily lives, and~     resulting in savings to the healthcare system~   "
16037|NCT03357029|"~     The purpose of this trial is to explore if a novel vagal neuromodulation approach provides~     analgesic benefit through central mechanisms in patients with chronic pancreatitis~   "
16038|NCT03357016|"~     Postmenopausal women, as men, are more prone to central or android obesity than premenopausal~     women. Abdominal fat mass accumulation is associated with an increase of cardiovascular~     disease (CVD) risk.~      Most exercise programs designed for weight loss have focused on about 30 min several times~     per week of moderate intensity continuous training (MICT). Disappointingly, such exercise~     programs have led to either none or low fat loss. Accumulating evidence suggests that high~     intensity interval training (HIIT) should be an effective exercise protocol for reducing body~     fat of overweight individuals, especially at the abdominal level.~      Resistance Training (RT) is associated with increased muscle mass and strength gain in main~     muscles groups. Thus, RT seems to be an interesting strategy to fight against deconditioning~     and autonomy loss with age. Development of muscle mass enhances resting metabolism rate.~     Thus, RT could raise daily energy expenditure ie. substrates' oxidation including lipids.~      The aim of our study was to compare the effects of a 12-week moderate intensity continuous~     training (MICT) program with high intensity interval training (HIIT) program combined or not~     with a resistance training (RT) program on total abdominal and visceral fat mass and~     substrate utilization in postmenopausal women.~      It is hypothesized that HIIT compared to MICT program would result in significantly greater~     whole body and regional fat mass losses (abdominal and visceral) and would improve lipid~     oxidation at rest and during prolonged moderate exercise. It is also hypothesized that HIIT~     associated with RT could be the best strategy to reduce fat mass.~   "
16269|NCT03354000|"~     Online patient portals are becoming ubiquitous in the US. Previous research has documented~     substantial usability barriers, especially among patients with limited health literacy. This~     pilot randomized pilot trial had the goal of determining the effectiveness of an in-person~     training with a scalable online video-based training program to increase portal use among~     patients in a safety net healthcare setting.~   "
16039|NCT03357003|"~     Tramadol is a grade II analgesics as World Health Organization definition. It can both be an~     agonist on mu receptors, which provides it a low opioid action, and also be a~     Serotonin-norepinephrine reuptake inhibitor, which act on neuropathic pain.~      Tramadol is metabolized by P450 2D6 cytochrome (CYP2D6) in O-desmethyltramadol (O-dt) which~     is the most active form on the pharmacologic side (analgesic effect 2 to 4 times more~     powerful than tramadol itself).~      In caucasian population, 5 to 10% of patients are genetically qualified as poor metabolizer~     phenotype; this status is correlated to a lower analgesic efficiency compared to rapid~     metabolizer.~      A multicenter study, CYTRAM, is under publication and allowed measurement of blood ratio~     O-dT/tramadol as a way to know the phenotype of CYP2D6 to detect poor metabolizer phenotype~     status.~      Indeed, blood ratio O-dT/tramadol threshold under 0.1 detects  poor metabolizer phenotype ~     status for postoperative patients treated by tramadol, with a good sensibility (87,5%) and~     specificity (83.8%).~      Which impacts for current practice? The next step is to know if this blood ratio is linked to~     an analgesic efficiency and a good tolerance for tramadol. A poor metabolizer phenotype~     patient would have no benefit of tramadol posology increasing. Therefore, phenotype~     detection, thank to blood ratio, could allow to switch quickly tramadol to another analgesic~     treatment for poor metabolizer phenotype patients.~      The main objective of the study is to forge a link between O-dT/tramadol ratio and analgesic~     efficiency. Secondary objectives investigate side effects and frequency related to~     O-dT/tramadol ratio and pain relief, and also impact of CYP2D6 - inhibitor treatments on the~     blood ratio.~      If there is a correlation between this blood ratio and treatment efficiency and tolerance,~     O-dT/tramadol ratio's detection will allow a better adaptation for some treatments~     metabolized by CYP2D6. Therefore, this evolution will contribute to health quality and health~     safety improvement.~   "
16040|NCT03356990|"~     The investigators want to learn more about how to help people who have chronic kidney disease~     (CKD). This study will increase the investigators understanding of how diet affects factors~     that can slow the progression of kidney disease. The investigators are asking 30 adults and~     30 children with stage 3 CKD to be part of this study. Participants will supplement their~     diet with resistant starch for two weeks. The investigators anticipate that the resistant~     starch will change the bacteria in the intestines to a more beneficial type of bacteria. The~     investigators will measure a product of these beneficial bacteria called butyrate. The~     investigators will also determine changes in the gut bacteria and products of the bacteria in~     the blood.~   "
16041|NCT03356977|"~     This 4-week study will evaluate the safety, pharmacokinetics (PK), and efficacy of~     crisaborole ointment 2%, applied twice daily (BID) in subjects who are 3 months to less than~     24 months of age with mild-to-moderate AD.~   "
16042|NCT03356964|"~     Step-down approach and late follicular phase progesterone level~   "
16043|NCT03356951|"~     Subtalar fusion is commonly performed in post-traumatic subtalar osteoarthritis, rheumatoid~     arthritis, posterior tibial tendon dysfunction, tarsal coalition and primary subtalar~     osteoarthritis. Patients with osteoarthritis or severe dysfunction involving both the ankle~     and the subtalar joint may benefit from an tibiotalocalcaneal fusion (TTC) or an ankle~     replacement and subtalar fusion. With the development of new prosthetic designs and of~     surgical techniques, total ankle replacements (TAR) became a reasonable alternative to fusion~     with functional and quality of life improvements. A gait analysis of patients that underwent~     TAR and simultaneous subtalar fusion allows to study with precision and reliability the ankle~     range of motion (ROM). On the contrary, in healthy subjects or in patients that underwent~     isolated TAR this is not possible because the ankle ROM is influenced by the ROM of the~     subtalar joint in such a way that it is not possible to analyze the two joints separately.~     Also, excluding the role of the subtalar joint, it is possible to accurately analyze and~     compare the consequences on ankle kinematics of two different prosthetic designs.~   "
16044|NCT03356938|"~     The aim of this study is to investigate the role of the circadian system in patients with~     neurologic sleep-wake disorders. Therefore, overnight sleep will be distributed over 30 hours~     into repetitive sleep-wake cycles (poly-nap protocol), so that sleep episodes occur at~     different circadian phases. Vigilance, attention, risk behavior as well as sleep onset~     latency will be observed.~      Ambulatory accelerometer recordings gain more and more attention in the diagnostic work-up of~     sleep disorders, as they allow to also include the everyday rest-activity rhythm before~     examinations in the sleep laboratory. Advances of novel devices should improve the detection~     of rest and activity and therefore the estimation of sleep and wake, especially in patients~     with neurologic sleep-wake disorders exhibiting fragmented sleep. Two types of actimeters~     will be applied throughout our study protocol to explore better classification of sleep and~     wake phases and patterns of the rest-activity rhythm.~      This study is designed as an observational case-controlled study targeting the disorders of~     narcolepsy type 1 and idiopathic hypersomnia, and including interventional procedures in the~     healthy control group (sleep deprivation, sleep restriction) in a counter-balanced design.~   "
16045|NCT03356925|"~     TB is a global health problem and in South Africa rates as the second most important problem~     in terms of Burden of Disease. There are many reasons for this, among which are diagnostic~     difficulties, extended treatments, drug resistance and health care provision. This~     application is concerned with all these drivers and will focus activities on a clinic which~     provides basic care in a very deprived socio-economic area of greater Cape Town, South~     Africa.~      Patients studied in routine, but demanding environments are our focus as these clinics are~     representative of many areas where TB (and HIV) are found at high prevalence. If the~     constraints of working in such areas can be understood and appropriate changes that work~     made, the investigators believe the outputs and policy changes generated in this study will~     contribute to future success in other settings.~      The investigators wish to study the implementation of the Xpert®MTB/RIF (Xpert) and Xpert~     Ultra (Ultra) systems in situ using a randomised controlled trial design, as opposed to a~     remote site (central laboratory), to assess whether time to diagnosis can be improved using~     point of care (POC). The investigators wish to maximise this opportunity by collecting~     biological samples from a patient population experiencing a TB epidemic for the evaluation of~     future TB diagnostics.~      Using human DNA, the investigators will attempt to determine reasons for poor or no treatment~     response. Two possibilities exist for this: a) the M. tuberculosis strain is resistant to the~     drug in question or b) the patient is highly susceptible to the bacterium. The investigators~     will determine the exome sequences of study participants with susceptible M. tuberculosis~     strains who show poor or no response, and compare this with rapid responders. Using 16S rRNA~     sequencing, the investigators will also observe how the microbiome of TB patients is altered~     during TB treatment and how this is associated with treatment outcome, as well as after TB~     treatment.~      This project will set the foundation for the implementation of new POC TB diagnostic~     technologies in clinics in South Africa. The biobanked specimens collected can be rapidly~     utilised for nascent technologies. Studying the patient microbiome will provide insights into~     what makes some patients more susceptible to TB and what microbiological changes occur during~     the course of anti-TB treatment.~   "
16078|NCT03356496|"~     Postoperative pulmonary complications (PPCs) are a source of much morbidity and mortality.~     Rates of PPCs exceed 30% in patients with multiple risk factors. Several studies have~     demonstrated reduced PPCs in patients who underwent preoperative inspiratory muscle training.~     These studies largely focused on cardiothoracic surgery and required the use of respiratory~     therapists. The investigators hypothesize that preoperative, self-administered respiratory~     therapy would reduce PPCs in patients with risk factors for PPCs undergoing any~     non-cardiothoracic surgery. This study is a randomized, controlled trial comparing~     preoperative use of an oscillating positive expiratory pressure (OPEP) device with usual care~     in patients undergoing non-emergent, non-cardiothoracic surgical procedures under general~     anesthesia.~   "
16046|NCT03356912|"~     Patients with metastatic castration resistant prostate cancer (mCRPC) progressed during or~     after a previous docetaxel-based chemotherapy, for whom cabazitaxel has been scheduled as per~     clinical practice and label indication.~      In the TROPIC Trial, cabazitaxel, administered concomitantly with prednisone 10 mg daily,~     showed a significant advantage vs. mitoxantrone in both Overall Survival (OS) and Progression~     Free Survival (PFS) / radiographic PFS in patients failing docetaxel-based chemotherapy.~     Similar to docetaxel, cabazitaxel has been approved in combination with daily prednisone, but~     the benefits of adding daily corticosteroids to taxane chemotherapy remain to be proven. In~     fact, corticosteroids have a variety of biological effects, and a number of studies in large~     cohorts of patients show that they may have both favourable effects, mediated by adrenal~     androgen and cytokine suppression, and detrimental effects related to their adverse events~     associated with their long-term use as well to the potential promiscuous activation of the~     AR. In fact, prednisone and dexamethasone can activate some AR variants that make tumors~     sensitive to glucocorticoids even at low concentrations. It has been showed that point~     mutations of the AR, which appear to cluster in the ligand-binding domain, are rare in~     therapy naive patients but occur in 15- 45% of patients with castration-resistant disease and~     can increase AR affinity for a wide range of steroids. On the other hand, insofar as safety~     is concerned, omitting daily corticosteroids does not seem to increase toxicity (e.g.~     hypersensitivity reactions). In fact, in the CHARTEED trial, docetaxel was safely~     administered without daily corticosteroids. Safety data about the use of cabazitaxel without~     daily prednisone/prednisone alone are missing.~      The CABACARE study is designed to assess the effects in terms of efficacy, safety as well as~     quality of life of omitting daily corticosteroids in patients treated with cabazitaxel.~     Furthermore, the CABACARE study evaluates the mutational status of the RB gene as well as~     presence of AR-V7 variant. The AR-V7 status assessed in circulating tumor cells has a strong~     predictive value for abiraterone/enzalutamide effectiveness, but its role in patients~     receiving cabazitaxel requires to be defined.~   "
16047|NCT03356899|"~     Shivering is very common after spinal anaesthesia. Many studies have investigated the role of~     adding adjuvants to the local anaesthetics to decrease the incidence of post-spinal~     shivering. Non of the studies n the literature review have investigated the role of different~     dose of local anaesthetic alone in reducing the incidence of post-spinal shivering. In the~     present study the investigators aimed to compare the effect of different local anaesthetic~     dose in reducing post-spinal shivering.~   "
16048|NCT03356886|"~     Objectives: The primary objective will be to investigate the additional effect (immediate and~     after one-month follow up) of pain neuroscience education (PNE) to Spinal Manipulative~     Therapy (SMT) on primary outcomes of pain intensity and disability in patients with chronic~     nonspecific low back pain (CLBP).~   "
16049|NCT03356873|"~     The investigators aim to determine the effect of the correction of vitamin D in vitamin D~     deficient patients (<15ng/ml) in oxidative stress and insulin resistance in patients with~     impaired glucose tolerance. Vitamin D deficiency has been associated with chronic low-grade~     inflammation, diabetes mellitus type 2, cardiovascular risk and increased prevalence of~     coronary heart disease, cerebrovascular disease and myocardial infarction.~   "
16050|NCT03356860|"~     The study has a phase Ib and a phase II part.~        -  The phase Ib aims to evaluate the safety and tolerability of durvalumab in combination~          with a dose- dense EC regimen in a neoadjuvant setting for early breast cancer.~        -  The phase II aims to explore the efficacy of durvalumab in combination with a dose-dense~          EC regimen in a neoadjuvant setting for early breast cancer.~   "
16051|NCT03356847|"~     A good efficacy as well as good rotary stability is expected with the ocular implant.~   "
16052|NCT03356834|"~     In Chronic hepatitis B (CHB) patients receiving long-term sequential Neucleos(t)ides(NAs),~     majority of these CHB patients experienced drug resistance and switched to Tenofovir~     disoproxil fumaratate(TDF). However, some of patients on long term TDF experienced impairment~     of renal function and bone mineral density. After Tenofovir alafenamide(TAF) was in clinical~     practice, these group of patients got an clinical option to switch from TDF to TAF. The~     investigators designed a prospective cohort study to evaluate the real life effectiveness and~     safety in participants with chronic HBV infection switch from TDF to TAF vs. maintaining on~     TDF.~   "
16053|NCT03356821|"~     This study will assess safety and feasibility of bone marrow-derived allogeneic MSCs,~     administered by the nasal route, in neonates who suffered from PAIS.~   "
16054|NCT03356808|"~     The purpose of this clinical trial is to assess the feasibility, safety and efficacy of~     cancer antigen-specific T cells targeting lung cancer. The cancer targeting antigens are~     identified through immunostaining of patient's cancer specimens. Another goal of the study is~     to learn more about the persistence and function of the ex vivo manipulated antigen-specific~     T cells in the body.~   "
16055|NCT03356795|"~     The purpose of this clinical trial is to assess the feasibility, safety and efficacy of CAR T~     cells immunotherapy in patients who have GD2, PSMA, Muc1, Mesothelin or other markers~     positive cervical cancer. Another goal of the study is to learn more about the persistence~     and function of CAR T cells in the body.~   "
16056|NCT03356782|"~     The aim of this clinical trial is to assess the feasibility, safety and efficacy of CAR T~     cells immunotherapy in patients who have sarcoma that is relapsed or late staged. Another~     goal of the study is to assess the safety and efficacy of the therapy that combines CAR T~     cells and IgT cells to treat sarcoma.~   "
16057|NCT03356769|"~     There had been much evidence in aspirin controlling tumorous conditions conducted by basic~     researches, especially through mammilian target of rapamycin (mTOR) pathway. The investigator~     observed efficacy of aspirin in the treatment of tuberous sclerosis complex (TSC) in one~     child who got Kawasaki disease and in the addition four TSC patients with epilepsy. The~     investigator intend to evaluate whether aspirin would be an effective add-on treatment in TSC~     patients with refractory seizures.~   "
16058|NCT03356756|"~     Myocarditis or inflammatory cardiomyopathy refers to inflammation of the heart muscle (the~     myocardium). Sarcoidosis is a multisystem granulomatous disorder that may involve the heart,~     causing inflammation, and potentially resulting in complications including arrhythmia and~     sudden death. The objective of this study is to evaluate the diagnostic and prognostic~     significance of simultaneous combined 18F-FDG PET and cardiac MRI imaging in the evaluation~     of inflammatory cardiomyopathies including cardiac sarcoidosis. Combined PET/MRI imaging may~     allow for detection and quantification of active myocardial inflammation as well as chronic~     fibrosis and scarring. Results of this study may allow for earlier detection of cardiac~     inflammation when compared with methods in current clinical use, and may lead to better~     understanding of the disease processes contributing to adverse outcomes. Elucidation of~     imaging findings associated with future adverse event risk may impact patient management such~     as providing an indication for pacemaker or defibrillator implantation, or escalation of~     medical therapy.~   "
16079|NCT03356483|"~     This study aims to investigate the effects of oral psilocybin on OCD symptomatology and~     provide the first evidence of the neural mechanism that may mediate psilocybin's purported~     therapeutic effects on OCD.~   "
16061|NCT03356717|"~     The increasing use of high-fidelity simulation is limited by the imbalance between the~     growing number of students and the human resources available in such a way that all residents~     cannot play a role during scenarios. The learning outcomes of observers need to be studied in~     more depth. Previous studies have provided controversial results but overall no significant~     differences in learning outcomes can be demonstrated between observers and participants~     engaged as players in scenarios.~      Moreover, preliminary data suggest that learning outcomes of observers might be improved by~     using an observer tool during the scenario. However, no high-quality study has yet shown if~     this assumption is verified.~      In the present study, 3rd-4th year residents in anesthesia will be randomized before high~     fidelity scenarios to act as observers only or active participants in some scenarios and~     observers in others.~      The main outcome parameter will be the learning outcomes by comparing data obtained before~     and after the sessions by using questionnaires specifically dedicated to the knowledge of~     technical skills in the management of crisis scenarios.~   "
16062|NCT03356704|"~     Hip fracture surgery requires high risk anesthetic procedure for elderly patients (1).~     General anesthesia, continuous spinal anesthesia and peripheral nerve blocks are three~     anesthetic techniques possible. Continuous spinal anesthesia has proven its efficacity to~     provide an intraoperative haemodynamic stability wich guarantees good patients outcomes (2),~     in comparison with general anesthesia but there is poor evidence in the litterature~     concerning the use of peripheral nerve blocks.~      The primary objective of this study was to compare intraoperative haemodynamic stability~     provides by peripheral nerve block versus general anesthesia and continuous spinal~     anesthesia.~      Secondary outcomes included : use of vasoactive drugs, opioids consumption, lenght of stay~     and inhospital mortality.~   "
16063|NCT03356691|"~     Background: Complementary Spiritist Therapy (ECT) based on a range of therapeutic resources~     including prayer, spiritist passe, fluidotherapy (fluidic water or magnetized water),~     spirit education. The aim of this study was to evaluate the effects of ECT in individuals at~     UFTM Hospital de Clínicas.~      Methods: Randomized controlled trial, patients were randomly. Patients will then be allocated~     into groups:~        -  The group submitted to ECT (prayer, spiritual education, spiritist passe and fluidized~          water or prayer or spiritist passe or laying on of hands with intent to heal or laying~          on of hands with intent to heal or fluidized water or no-fluidized water or Control~          group (CG) will not be submitted to any intervention.~   "
16064|NCT03356678|"~     A non-interventional, multicenter, multinational retrospective analysis using electronic case~     report forms completed by the investigators based on information from patient medical records~   "
16065|NCT03356665|"~     The study determines the diagnostic performance and cost of rapid diagnostic tests (RDTs)~     performed on human African trypanosomiasis clinical suspects in peripheral health centres,~     whether or not followed by serological and/or molecular tests on dried blood spots done at~     regional reference centres~   "
16066|NCT03356652|"~     Background~      Cardiac Resynchronization Therapy (CRT) is proven to improve survival and heart function of~     patient with certain electrical conduction abnormality and heart failure. However, in patient~     with certain electrical conduction abnormality, a good response is observed in less than 40%~     in patient receiving CRT. Conventionally the surgical approach of CRT is to implant one~     pacing lead in the right heart and one in the left heart to resynchronize the contraction and~     the pacing lead in the left heart is usually placed in the posterior or lateral portion of~     the left heart. However, this single approach may not be optimal, especially for those~     patients with conduction abnormality known to have poor response to CRT.~      Purpose of the clinical investigation~      The purpose of the Electrical Activation Guided CRT Study is to study the effectiveness of a~     tailored made approach to CRT procedure by using a noninvasive globally mapping system~     studying the electrical conduction under different approaches to delivery CRT. The pacing~     approach that optimally corrects conduction abnormality will be determined before the actual~     implantation procedure.~      Conduct of the Investigation~      This study will include 93 patients with conduction abnormality that known to have a poor~     response to CRT from Prince of Wales Hospital, Hong Kong.Subjects will be followed up at 3~     months and 6 months visit.~   "
16067|NCT03356639|"~     The primary purpose is to evaluate the safety and tolerability of ASP6981 in participants~     with schizophrenia.~      Also primary purpose is to evaluate the pharmacodynamics of ASP6981 in participants with~     schizophrenia as measured by cognitive function and neurophysiological biomarkers.~      The secondary purpose of this study is to evaluate the pharmacokinetics of ASP6981 in~     participants with schizophrenia.~   "
16068|NCT03356626|"~     To find out which instrument can be much better for laparoscopic gastrectomy among Harmonic~     scalpel, Ligasure Maryland, Thunderbeat~      comparing postoperative CRP level in each group~   "
16069|NCT03356613|"~     In order to develop paramedical research culture, the paramedical staff need adapted tools~     and methods. The GenI project (Research ideas generation) has for main objective the design~     and validation of a tool that will allow the identification of paramedical research ideas.~     This tool will be built based on paramedical staff views. Our hypothesis is that the use of~     the GenI tool will help to detect research ideas in paramedical health care that could lead~     to research projects.~   "
16070|NCT03356600|"~     To observe the effectiveness and safety of apatinib combined with radiotherapy for brain~     metastasis from non-small cell lung cancer patients~   "
16071|NCT03356587|"~     Open, multicenter, single arm, phase II, biomarker driven umbrella trial for head and neck~     squamous cell carcinoma (FGFR inhibitor, CDK4/6 inhibitor, pan HER inhibitor, PI3K inhibitor,~     PD1/PD-L1 inhibitor)~   "
16072|NCT03356574|"~     A nationwide observational study. Children operated with single-ventricle palliation between~     January 1994 and December 2017 operated in Sweden will be included retrospectively. Patients~     born with a functionally single ventricle but not undergoing surgery will not be included.~     Data regarding preoperative clinical characteristics and operative details will be obtained~     by medical records review and from The Swedish Registry of Congenital Heart Disease~     (SWEDCON). Using unique personal identity numbers assigned to all residents of Sweden, data~     from SWEDCON will be linked with dates of death.~   "
16073|NCT03356561|"~     The purpose of this study is to assess the safety, reactogenicity, and immunogenicity of~     Ad26.ZIKV.001 at 2 dose levels, 5*10^10 viral particles (vp) and 1*10^11 vp, administered~     intramuscularly as single dose and as 2-dose schedules in healthy adults.~   "
16080|NCT03356470|"~     This study uses molecular imaging and novel immune monitoring to identify a biomarker of~     response for melanoma patients receiving immunotherapy with anti-PD-1 immunotherapy. Prior to~     treatment, FDG and FLT PET/CT will be obtained, together with blood and tumor biopsies from~     each patient. A follow-up FDG and FLT PET/CT will be obtained, together with blood and tumor~     biopsies, 10-12 weeks after starting treatment with anti-PD-1 antibody. Additional tumor~     biopsies and blood samples for immune monitoring will be obtained 4-6 weeks after starting~     treatment with anti-PD-1 antibody as well as 16-18 weeks after starting anti-PD-1 treatment~     for patients still receiving anti-PD-1 antibody at that time.~   "
16081|NCT03356457|"~     To determine the effect of re-activation of brain glucose metabolism induced by~     dichloroacetate (DCA) on cognitive function and counterregulatory hormone responses in~     patients with type 1 diabetes (T1DM) with recurrent hypoglycemia.~   "
16082|NCT03356444|"~     Metastatic castration-resistant Prostate cancer (mCRPC) is a very late stage of prostate~     cancer with poor prognosis. Although there are several treatment strategies available for~     mCRPC, these drugs are not always effective for every patient. Also, it's still not clear~     what's the best therapeutic choice for a certain group of patients.~      In the previous works of the investigators, a subtype of prostate cancer, intraductal~     carcinoma of the prostate (IDC-P) was studied. The investigators have reported in their two~     published papers that, IDC-P is an adverse pathological type associated with rapid disease~     progression. They also found in another study that, for patients with IDC-P, Abiraterone~     seemed to have better treatment efficacy than Docetaxel-based chemotherapy as first-line~     treatment for mCRPC, in terms of either PSA-response and PSA-progression free survival. So,~     in this study, the investigators hope to design a prospective study to verify the predictive~     ability of IDC-P in the first-line treatment of mCRPC.~      With disease progression, the drug resistance will inevitably occur in all patients after the~     treatment of CRPC. However, the exact mechanism of this process is not yet known. So, in this~     study the investigators are also trying to explore some of the genes related to the treatment~     efficacy by means of the next generation sequencing.~   "
16083|NCT03356431|"~     Physical exercise is a widely recommended treatment modality for osteoarthritis, which can be~     performed through a supervised group exercise or a home exercise program. However, up to now~     only little research has been conducted on the home exercise program in Brazil. The objective~     of this study is to compare the efficacy between supervised group exercise and home exercise~     program in people with knee osteoarthritis. Methods: The study population consists of 46 men~     and woman with knee osteoarthritis aged between 40 and 65. The patients should be clinically~     diagnosed with knee osteoarthritis and classified in Kelgreen-Laurence grades I, II and III.~     Primary outcomes are the Westerm Ontário and McMaster Universities (WOMAC), Lower Extremity~     Functional Scale (LEFS), Pain Catastrophizing Scale (PCS), Tampa Scale for Kinesiophobia,~     40-meter walk test, isometric strength of hip (abduction and adduction) and knee (flexion and~     extension) and postural control. The patients are randomized into 2 groups, with one group~     receiving 12 sessions of supervised group exercise and the other group following an exercise~     program at home. The program lasts 6 weeks with both groups receiving the same exercise~     protocol consisting of stretching, isometric and isotonic exercises for major muscle groups~     in both lower extremities. The Mann-Whitney U test is used to examine the Anthropometric~     variables. The ANOVA is used to compare outcomes before and after treatment. A value of p<~     0.05 is considered to be statistically signifcant.~   "
16084|NCT03356418|"~     The purpose of this study is to analyze the immediate effects of an exercise protocol on the~     vibration platform on the functional and neuromuscular performance of lower limbs, postural~     control and life quality in healthy elderly.~   "
16085|NCT03356405|"~     The aim of this study is to conduct an evaluation of hepatitis C treatments in NHS Tayside in~     order to empirically test the treatment as prevention models. This will be done by~     analysing the records of patients who have been tested and treated for hepatitis C using NHS~     Tayside databases. There will be no interventions carried out as part of this study.~   "
16086|NCT03356392|"~     The German Stroke Registry (GSR) Endovascular Treatment is an academic, independent,~     prospective, multicentre, observational registry study. Consecutive patients treated with~     endovascular stroke treatment will be enrolled in German stroke centers. Patients receive~     regular care and data will be collected as part of clinical routine. Baseline clinical and~     procedural information as well clinical follow-up information during in-hospital stay, and up~     to 90 days of stroke onset are collected. Data collected include demographics, National~     Institute of Health Stroke Scale (NIHSS) on admission, pre-treatment ASPECTS, information on~     timing and success of interventional treatment, procedural complications, intracranial~     hemorrhage, and functional outcome.~   "
16087|NCT03356379|"~     Aim of the study is to test the feasibility of transcutaneous oxygen pressure (TcPO2)~     recording in the diagnosis of popliteal entrapment syndrome (PES) in 30 patients with~     suspected PES and 30 asymptomatic control heathy subjects~   "
16088|NCT03356366|"~     Multiple sclerosis (MS) is the first non-traumatic cause of disability in young people,~     responsible for physical but also cognitive deficits. MS is an inflammatory demyelinating and~     degenerative disease of the central nervous system. Recently, MRI technics have demonstrated~     their sensibility to the different processes involved in MS. Particularly, MRI has evidenced~     that the pathological process of MS is not restricted to the macroscopic lesions of the white~     matter but also involves the normal appearing white and grey matter. In the normal appearing~     brain tissue, demyelination, neuronal suffering and neuronal loss have been evidenced.~     Moreover, MRI has demonstrated the existence of brain functional reorganization processes~     that may limit the clinical expression of pathological injuries. Despite these important~     findings, the pathological underpinnings of irreversible disability are largely unknown. The~     present project aims to depict the main determinants of physical but also cognitive~     disability in patients with MS. To do this, a longitudinal study including 70 patients with~     MS using different MRI markers known to be sensitive to the different pathological aspects of~     MS will be performed. The relationships between these markers and the progression of~     disability will be assessed. Identification of the main pathological underpinnings of~     irreversible disability of MS will provide the most relevant therapeutic targets.~   "
16315|NCT03353402|"~     Altering the Gut Microbiota of Melanoma Patients Who Failed Immunotherapy Using Fecal~     Microbiota Transplantation (FMT) From Responding Patients.~      FMT includes both colonoscopy and stool capsules, conducted in an outpatient setting.~   "
16089|NCT03356353|"~     Continuous-flow left ventricular assist devices (LVAD) move blood from the left ventricle~     (the largest chamber of the heart) to the aorta (the body's main artery) to help the heart~     better meet the needs of the body and to improve survival for patients with advanced heart~     failure (HF). The ability of the right ventricle (the large chamber on the right side of the~     heart) to keep up with the improved blood flow following LVAD greatly effects how well a~     person does following surgery. It is understood that a high pulmonary artery pressure~     (pressure in the blood vessel that takes blood from the right side of the heart to the lungs)~     measured before surgery, indicates that a higher risk of right heart failure exists after~     LVAD implantation.~      This is important because right heart failure after surgery is related to longer intensive~     care unit (ICU) and hospital stays, increased morbidity (other health problems) including~     organ failure and worse outcomes following heart transplant, and increased death rates.~      Sildenafil (Revatio®) has been approved by Health Canada in the treatment of pulmonary~     arterial hypertension (high blood pressure in the lungs) in patients with connective tissue~     disease. Sildenafil has not yet been approved by Health Canada for the treatment of pulmonary~     hypertension in heart failure. Sildenafil lowers blood pressure in the lungs and lessens the~     workload of the right ventricle (the right side of the heart). The purpose of this study is~     to determine if lowering blood pressure in the lungs, in heart failure patients at risk for~     developing right heart failure after LVAD implant, lowers the incidence of right heart~     failure, shortens ICU and hospital stays and reduces morbidity (other health problems) and~     mortality (death rates).~      This is an open label, single arm study. Everyone who participates in this study will receive~     sildenafil before and after LVAD surgery. It is expected that 24 patients who are scheduled~     to have LVAD implantation for advanced heart failure will be enrolled from 6 sites across~     Canada. Participants will be followed in the study for about 2 months.~   "
16090|NCT03356340|"~     The Singapore Chinese Health Study is a cohort study established by the Department of~     Epidemiology and Public Health in National University of Singapore, together with~     collaborators from several universities in the United States of America. This is a long-term~     study to help doctors and scientists understand the influence of diet, lifestyle and~     environment on the development of common diseases among Singaporean men and women. This~     includes cancer, heart disease, stroke, dementia, osteoporosis, high cholesterol and~     diabetes. The aim is to help us understand the causes of these diseases and to discover~     effective and efficient approaches for prevention and treatment.~   "
16091|NCT03356327|"~     A pilot, randomized, case-controlled trial was conducted in 60 children affected by AG (< 7~     days) with mild-moderate dehydration, according to WHO recommendations, from1 year to 17~     years old. Patients were divided into 2 Groups: Group 1 consisting of 30 children treated~     with Actitan F and standard oral rehydration (SOR); Group 2 consisting of 30 children who~     received only SOR. Both groups received treatment for seven days, respectively. Patients of~     Group 1 stopped for their own choice, SOR after the first 24 h and continued only with~     Actitan F.~   "
16092|NCT03356314|"~     The aim of this study was to assess the value of an unusual relative position of the superior~     mesenteric artery (SMA) and vein (SMV) to screen intestinal malrotation with a higher risk of~     volvulus.~      First, feasibility study was done to prove the reproducibility of ultrasound in diagnosis of~     anormal mesenteric vessels position.~      A systematic screening of the mesenteric vessels position was performed at each pregnancy~     required ultrasound.~      When the fœtus had an unusual position of the mesenteric vessels, an MRI was suggested~     between 30 and 35 GA and the couple met the pediatric surgery team.~      Few days after birth, an abdominal ultrasound was achieved as well as a barium enema and~     upper gastrointestinal. If there were a hight probability of malrotation with a higher risk~     of volvulus, a prophylactic surgery was proposed. The children were flollowed up during 1~     year.~   "
16093|NCT03356301|"~     Regular sustained physical activity creates a cardiac remodelling : it is athlete's heart. In~     our preliminary work published in 2016, the investigators demonstrated in a small population~     of triathletes that there is also a vascular remodelling named athlete's artery. Moreover,~     the investigators know that left ventricle and aorta behave together like a couple. So they~     want to study by Cardiovascular Magnetic Resonance Imaging the impact of triathlon on the~     cardiac AND aortic remodelling.~   "
16094|NCT03356288|"~     This study will test the use of a new handheld device (called the N-Tidal C), that measures a~     person's tidal breath carbon dioxide, in diagnosing the cause of someone's breathlessness. It~     will also evaluate whether this device can detect when a person's breathing problem is~     getting worse.~   "
16095|NCT03356275|"~     Chronic pain is estimated to affect 20% to 35% of children and adolescents around the world,~     and is associated with increased risk of anxiety and depression among children and~     adolescents, as well as coping challenges, anxiety, depression, and anger in their parents.~     For parents, learning to manage stress is critical, as parents play a significant role in a~     child's experience of pain. Parental behaviors such as over-involvement, solicitousness and~     rejection are associated with decreased functioning, including higher school absenteeism in~     children and teens. A number of interventions demonstrate that teaching skills to parents can~     have a direct and positive impact on the health of children and adolescents with chronic~     pain. The investigators propose to create and test the BodiMojo Parent Buddy which will~     provide parents with real-time, tailored and adaptive coping and stress management support~     and will provide a curriculum of skills for responding to a child in pain in order to promote~     child functioning.~      Thirty parents of children ages 8-18 who have been diagnosed with a non-cancer chronic pain~     condition will participate in this user-testing study. Parents will complete a brief set of~     questionnaires before and after the intervention, and will be instructed to open and use the~     app each day for 30 days. Participants will complete audio mindfulness exercises, watch brief~     video clips, and read psychoeducational information about pain, coping, and communication~     skills. Post-intervention questionnaires will also include an acceptance test to assess~     participants' opinions about the helpfulness and usability of the app. Parent participation~     is expected to take around 3.5 hours total over the 30 day study period.~   "
16096|NCT03356262|"~     The QUebec Adipose and Lifestyle InvesTigation in Youth (QUALITY) Cohort study is a unique~     and comprehensive longitudinal study of 630 Caucasian children and their parents that was~     designed to investigate the natural history and determinants of childhood obesity and its~     cardiometabolic consequences.~   "
16117|NCT03355976|"~     Preclinical and early-phase clinical data suggest that immune modulation represents a~     treatment strategy that is worthy of further investigation in relapsed epithelial ovarian~     cancer. One method by which tumor cells may evade immune surveillance is by activation of the~     programmed cell death (PD-1) pathway, mediated by expression of PD-1 on the surface of T~     lymphocytes, which conveys an inhibitory signal after binding to its ligand PD-L1 on the~     surface of tumor cells. Nivolumab and Ipilimumab have shown activity as monotherapies in~     solid tumors and very early data suggest that nivolumab may be particularly active for~     ovarian clear cell carcinoma.(Hamanishi et al., 2015). Given the uniformly poor prognosis for~     patients with clear cell carcinoma in general, we are interested in formally evaluating this~     agent in all extra-renal clear cell carcinomas.~   "
16097|NCT03356249|"~     Sepsis remains a major challenge, even in modern intensive care medicine. The identification~     of the causative pathogen is crucial for an early optimization of the antimicrobial treatment~     regime in patients with sepsis. In this context, culture-based diagnostic procedures (e.g.~     blood cultures) represent the standard of care, although they are associated with relevant~     limitations. Therefore, culture independent methods (e.g. Next-Generation Sequencing (NGS))~     seem to be an attractive alternative. By the identification of circulating cell-free DNA in~     the blood and the use of the quantitative sepsis indicating quantifier (SIQ) score, causing~     pathogens can be identified and potential contaminations can be excluded.~      The goal of the presented study is therefore, to assess the diagnostic performance of a~     NGS-based approach for the detection of relevant infecting organisms in a big cohort of~     septic patients (n=500). Moreover, the plausibility of this NGS-based approach will be~     estimated by a panel of independent clinical specialists, retrospectively identifying~     potential changes in patients´ management based on NGS results.~   "
16098|NCT03356236|"~     To evaluate the efficacy and safety of Huaier Granule for Prevention of Recurrence and~     Metastasis of Hepatocarcinoma following Local Ablation~   "
16099|NCT03356223|"~     This trial is an open-label, single arm, Phase II study using an A'Hern single stage design.~      The molecular prescreening step will allow to defined HPV tumor status as well as molecular~     status CDKN2A, CCND1 and CDK6. Following this centralized molecular screening, only patients~     with HPV negative status and with tumor harboring CDKN2A homozygous deletion and/or CCND1~     amplification and/or CDK6 amplification could initiate abemaciclib at time of documented~     radiological progression. Patients will be treated with ABEMACICLIB, 400 mg/day with 2 doses~     of 200 mg 12 hour apart (QH12). A cycle is defined as an interval of 28 days. For each 28-day~     cycle, a total of 56 doses of study drug will be dispensed.~   "
16100|NCT03356210|"~     The proposed randomized controlled trial (RCT) will investigate the usefulness of~     electroencephalographic (EEG) biofeedback, also called neurofeedback (NF), a treatment method~     that can potentially prevent relapses among patients with a substance use disorder (SUD)~     through its calming effect on the central nervous system.~      The study will examine whether NF can improve general well-being and quality of life (QoL)~     and subsequently its ability to play a role in relapse prevention strategies. Specifically,~     the effect on physical and psychological distress will be investigated.~   "
16101|NCT03356197|"~     Epidemiology of Conjunctivitis in the Emergency Department of a Reference Ophthalmological~     Hospital in Goiânia.~   "
16102|NCT03356171|"~     APACCHE (Adapted Physical Activity and Cardiac Coherence in HEmatologic patients) study~     investigates effects of heart rate variability biofeedback training, combined with classical~     adapted physical activity, on health-related quality of life in patients previously treated~     for hematologic malignancies. It is a prospective, randomized clinical trial from University~     Hospital of Reunion Island. The main objective is evaluated with QLQ-C30 survey score~     differences.~   "
16103|NCT03356158|"~     This is an open-label, parallel designed study to assess the pharmacokinetics, safety and~     tolerability of the single-dose and multi-dose of a recombinant anti-EGFR monoclonal antibody~     (CPGJ602) in patients with at least one prior chemical regimen failed metastatic colorectal~     cancer. The immunogenicity and preliminary efficacy of CPGJ602 will also be assessed. The~     study includes 3 parts: part 1: after a single dose of CPGJ602 or cetuximab (the active~     comparator), the patients will be observed for 4 weeks; part 2: CPGJ602 or cetuximab will be~     administered to the patients once a week for 5 weeks; part 3: CPGJ602 will be administered to~     the patients once a week until the patient's death or the withdrawal decision of the patient~     and/or investigator.~   "
16104|NCT03356145|"~     More research is needed to investigate methods of pain control for cervical preparation for~     abortion procedures. Women report pain with paracervical block injection as well as with~     osmotic dilator placement. This study seeks to compare a 12 mL, 2-site 1% plain lidocaine~     paracervical block for pain control during cervical preparation (osmotic dilator insertion)~     for Dilation and Evacuation (D&E) to a 20 mL 1% lidocaine 2-site paracervical block.~   "
16105|NCT03356132|"~     The study investigates the safety and performance of Silimed® silicone gel breast implants~     with a textured surface and Silimed® silicone gel breast implants with polyurethane coated~     surface. Female patients who underwent primary breast augmentation using Silimed® breast~     implants will be followed-up through 10 years. The safety of each type of Silimed® breast~     implant is going to be assessed by estimating the known and unexpected short- and long-term~     risk / adverse event rates. The performance of each type of Silimed® breast implant is going~     to be assesses by estimating the satisfaction and quality of life after implantation.~   "
16106|NCT03356119|"~     There are no implant removal devices on the market by any manufacturer. Overall, the~     RemovAid™ combines the features of fixation, incision and extraction. This combination of~     functions has not previously been combined in a single device.~      The investigators wish to perform this pilot clinical investigation with the aim to~     demonstrate that the Investigational Medical Device (IMD), RemovAid ™, may safely and~     effectively facilitate implant removal. Other aims are to show that the IMD have the~     potential to reduce procedure length variability, reduce procedural complexity and reduce the~     need for additional procedural equipment related to CI removal procedures, without causing~     any harm to the subject.~   "
16107|NCT03356106|"~     This is an open-label multicenter randomized-controlled trial in 3 tertiary care hospitals~     including Ramathibodi Hospital, Phramongkutklao Hospital and Rajavithi Hospital. The study~     involved screening of obstructive sleep apnea in high risk pregnancy during 1st and 2nd~     trimesters. Randomization to either continuous positive airway pressure (CPAP) or usual~     antenatal care (ANC) until delivery will be done. Efficacy of CPAP on pregnancy outcome will~     be analysed.~   "
16152|NCT03355521|"~     The aim of this study was to evaluate and compare the effects of a Nordic and free walking~     training program on clinical, functional and biomechanical parameters of gait, in people with~     PD.~      Outcomes: Motor symptoms: Staging and severity of PD, balance, walking functional mobility,~     self-selected walking velocity, and rehabilitation index. Non-Motor symptoms: Cognitive~     function, depressive symptoms, and quality of life (QL). Outcomes Biomechanics: Kinematic~     parameters (spatiotemporal and dynamic stability of walking) and neuromuscular parameters~     (amplitude of the electromyography signal, initial and final activation threshold, activation~     time and co-contraction index, of the following muscles: Vastus Lateralis (VL), Biceps~     Femoris (BF), Tibialis Anterior (TA), Gastrocnemius Medialis (GM).~   "
16108|NCT03356093|"~     Head and neck cancer (HNC) is the sixth most common malignancy worldwide, causing more than~     379,000 deaths in 2015 notwithstanding the breakthrough in cancer screening and medical~     treatment. The primary treatment for HNC is a combination of surgery and radiotherapy, either~     delivered preoperatively or postoperatively. Although these treatments, especially the~     postoperative radiotherapy can greatly improve the survival of patients, they still have to~     pay a high price for numerous symptoms induced by radiation. On the other hand, research on~     symptoms clusters is an emerging field in oncology which aims to understand the complexity of~     multiple symptoms experienced by cancer patients. A thorough understanding of symptom~     clusters help informs the development of comprehensive care plans which target a group of~     symptoms that is likely to coexist, thus easing the total symptom burden in cancer~     patients.To date, there has been a paucity of evidence regarding symptom clusters of HNC. To~     address the gap in existing literature, this study described the symptom clusters among HNC~     patients who were treated with surgery with a combination of postoperative radiotherapy. In~     addition, a longitudinal approach was employed to examine the change in symptom clusters~     throughout the treatment course.~   "
16109|NCT03356080|"~     The purpose of this study is to evaluate of the clinical efficacy and safety of DLAAG~     protocol in the treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome with~     blast excess~   "
16110|NCT03356067|"~     Gastroparesis is a disorder triggered by numerous causes and it is defined by symptoms and~     with an objective evidence of delayed gastric emptying in the absence of obstruction.~      Effective treatment for gastroparesis is challenging especially in patients with severe~     symptoms. In refractory gastroparesis, endoscopic or surgical treatments may therefore be~     considered. Endoscopic treatments include intrapyloric injection of botulinum toxin and~     transpyloric insertion of a metallic stent. Surgical options involve implantation of a~     gastric pacemaker (gastric stimulation), pyloroplasty and subtotal gastrectomy.~      Recently, a new endoscopic technique, gastric endoscopic per oral pyloromyotomy (G-POEM) has~     been introduced with promising preliminary results.~      The aim of this prospective, sham-controlled, cross-over study (cross-over for patients~     randomized to the sham arm) is to compare short and long-term efficacy and safety of G-POEM~     in patients with refractory gastroparesis. Symptoms and objective parameters of gastric~     emptying will be the main outcome criteria. The reason of using a sham protocol is to control~     for the potential confounders (therapeutic effects of touch and belief, which are components~     of the placebo effect).~   "
16111|NCT03356054|"~     Patients with CD30 positive DLBCL, primary refractory or in first relapse after R-CHOP or~     R-CHOP-like therapy will receive brentuximab vedotin in combination with R-DHAP, followed in~     responsive patients by high dose chemotherapy and ASCT.~   "
16112|NCT03356041|"~     The aims of this study are to determine the prevalence of diabetic peripheral neuropathy~     among the diabetic patients, to determine the association between the clinical profiles of~     the diabetic patients (diabetes type, diabetes duration, HbA1c, body mass index,~     hypertension, total cholesterol) and the diabetic peripheral neuropathy DPN and the rational~     poly pharmacy used to control pain.~   "
16113|NCT03356028|"~     On July 14, 2016, in Nice, children and their families were attacked by the organization~     EI. In Nice, 86 deaths, including 10 children, the youngest at 4, were recorded. A number~     of children, still difficult to assess exactly but over 100, was bereaved.~      After a traumatic event, multiple clinical consequences may appear in children. Among these~     consequences, the most common is Post-Traumatic Stress Disorder (PTSD). The aim of the study~     is to characterize the psycho-social factors of risk and / or protection interfering in the~     children's future, following the mass trauma of 14 July 2016 in Nice on a sample of pediatric~     population exposed in comparison of children controls.~   "
16114|NCT03356015|"~     High quality bowel preparation is essential for successful colonoscopy. This study aimed to~     assess the impact of the dose of Polyethylene Glycol(PEG) on the quality of bowel~     preparation. This prospective, endoscopist-blinded, randomized, controlled study was~     conducted. 3L-group received 3 bags of PEG and were instructed to drink 1L at 19:00 in the~     evening before the day of colonoscopy at a rate of 250 mL every 15 minutes, and to drink the~     remaining 2L 4 to 6 h before colonoscopy at the same rate. 4L-group received 4bags of PEG and~     were instructed to drink 2 L at 19:00 in the evening before the day of colonoscopy at a rate~     of 250 mL every 15 minutes, and to drink the remaining 2L 4 to 6 h before colonoscopy at the~     same rate. The primary outcome was the quality of the bowel preparation according to the~     Boston Bowel Preparation Scale (BBPS). The secondary outcomes included polyp detection rate~     (PDR), adenoma detection rate (ADR), tolerance, and subjective feelings of patients.~   "
16115|NCT03356002|"~     The purpose of this study is to establish the efficacy of Check-Cap's C-Scan System in~     providing structural information on colonic polypoid lesions and masses, as an adjacent tool~     to Feacal Immunochemical Test [FIT] in high risk subjects~   "
16116|NCT03355989|"~     Like many developing countries, Pakistan faces a public health challenge of low and~     incomplete immunization rates of children, only 54% of children aged 12 to 24 months are~     fully immunized, which leaves children susceptible to vaccine-preventable diseases. The~     Expanded Program on Immunization (EPI) is a low-cost and effective health intervention, but~     the uptake is low, delayed, and completion rates are poor.~      Door-to-door campaigns can increase coverage, but are extremely expensive. Incentive-based~     approaches have been rigorously demonstrated to effectively increase take-up and completion~     rates of immunization, and there is substantial evidence that small incentives can have a~     large impact on the take up of preventative health behavior in general. There are two major~     constraints to scaling these findings, however.~      This study will attempt to find the most effective incentive design that helps increase the~     coverage of full immunization rates among children between the ages of 0 - 24 months in the~     city of Karachi, Pakistan. The study proposes to conduct a randomized control trial involving~     small conditional cash transfers (mCCTs) to determine the optimal CCT amount (high versus~     low), schedule (flat versus increasing) and design (lottery versus sure payment) that would~     lead to the highest increase in immunization rates. Interactive Research and Development's~     digital immunization registry will be used to enrol and randomize the study participants and~     generate CCTs disbursed through a mobile money transfer platform and mobile top - ups . The~     three year study will be conducted in Karachi, Pakistan enrolling a sample of 11,200~     children, 0-2 years of age.~      The study aims to provide evidence regarding the most cost-effective way to structure~     incentives in terms of size, schedule, and design; and address the challenge of delivering~     small incentives in a way that is inexpensive, logistically simple, and not subject to~     leakage.~   "
16153|NCT03355508|"~     40000 patients are hemodialysis each year in France .~      In the case of chronic care, 78% of patients have an arteriovenous fistula. In order to~     perform the hemodialysis session, 2 techniques of puncture of the fistula are possible:~        -  Bevel puncture upwards then flipping the needle~        -  or puncture bevel down. At present, there is no consensus or study on the technique of~          puncture fistula which generates different professional practices.~   "
16118|NCT03355963|"~     purpose: The aim of this study is to compare the safety, efficacy and durability of different~     doses of BTX-A (50 and 100 unit) in the treatment of Vasculogenic Erectile Dysfunction after~     failure of other ICI therapy.~      Patients and Methods: This study will be conducted on 100 patients diagnosed as vascular~     erectile dysfunction by penile color Doppler not responding to medical and injection therapy~     presenting to Urology department and outpatient clinic at Benha University Hospital,~     Andrology, Sexology & STD's outpatient clinic, Kasr El Aini Hospitals, Cairo~     University.(multicentric study).~      A- Inclusion criteria:~        -  Age between 40 to 70 years.~        -  Vascular ED proved by penile duplex.~        -  Unable to develop erections sufficient for intercourse.~        -  A No response on Sexual encounter profile questions (SEP 2 & 3)~        -  Failing to respond to first line and second line treatments for Erectile Dysfunction~          with surgery as the only remaining treatment option.~      B-Exclusion criteria:~        -  Significant cardiovascular disease interfering with sexual activity~        -  Any history of an unstable medical or psychiatric condition~        -  Any presence of penile anatomical abnormalities (e.g. penile fibrosis) that would~          significantly impair erectile function.~      patients will be simply randomized into 3 equal groups, one control group and tow treatment~     groups. Ethics committee approval and informed consent were obtained.~      Group A: control group contain 15 patients Group B: first treatment group contain 15 patients~     Group C: second treatment group contain 15 patients~   "
16119|NCT03355950|"~     The purpose of this study is to determine and compare the possible affects of two different~     inguinal hernia repair technique (TEP and Lichtenstein) on serum ASA levels.~   "
16120|NCT03355937|"~     In order to increase the likelihood of achieving IVF-treated pregnancy, good quality embryo~     transfer is important. To get good quality embryos, good quality gametes are needed. The~     selection of sperm is regulated according to the changing and mobility characteristics of~     today's conditions. The choice of multi-fluid sperm is thought to provide better sperm to~     obtain the environment in physiological conditions. Better embryo transfer to achieve better~     sperm elongation will increase the likelihood of pregnancy.~   "
16121|NCT03355924|"~     The aim of this study is to describe the outcomes of phaco-DMEK (Descemet Membrane~     Endothelial Keratoplasty ) according to a sequential versus a combined procedure~   "
16122|NCT03355911|"~     To evaluate the impact of preoperative corneal thickness on visual outcomes following~     Descemet's stripping endothelial keratoplasty (DSAEK) or Descemet membrane endothelial~     keratoplasty (DMEK)~   "
16123|NCT03355898|"~     Lorraine is one of the most affected French region by cardiovascular diseases with a~     mortality rate for ischemic heart disease higher than the national average in 2010. Due to~     practice change with the new recommandations of the European Society of Cardiology involving~     the myocardic revascularization, the investigators wanted to compare the Stemi care in~     2005-2006, 2010-2011 and 2015 in the CHR Metz-Thionville.~   "
16124|NCT03355885|"~     Early-onset pneumonia after out-of-hospital cardiac arrest is frequent. An association~     between early-onset pneumonia and an increase in morbidity has been reported in this~     population. The diagnosis of early-onset pneumonia inpatients with out-of-hospital cardiac~     arrest may be challenging as diagnosis criteria are unspecific in this setting. On the other~     hand some studies have reported an association between early antibiotics and better prognosis~     in patients with out-of-hospital cardiac arrest suggesting that early diagnosis and treatment~     of pneumonia would benefit to patients. Nonetheless, adminitration of antibiotics to any~     patients with out-of-hospital cardiac arrest would expose to antibiotic patients without~     infection and woould participate to increase in antibiotic resistance.~      Therefore, the PP-ACR study aims to evaluate the impact of a diagnosis algorithm including~     blinded sampling protected brushes on early-onset pneumonia treatment and patient prognosis~     after out-of-hospital cardiac arrest.~   "
16125|NCT03355872|"~     To compare the PK profiles of HLX01 and Rituximab in Chinese patients with moderate to severe~     rheumatoid arthritis.~   "
16126|NCT03355859|"~     This is a single arm, open-label, dose escalation clinical study to evaluate the safety and~     efficacy of infusion of autologous CD19-targeted chimeric antigen receptor (CD19 CAR) T cells~     in adult patients with relapsed and refractory B-cell Non-Hodgkin lymphoma.~   "
16127|NCT03355846|"~     Starting from the observation that acute anal fissure (AAF) in 6-8 weeks can heal~     spontaneously and that some of the commonly used commercial products in clinical practice~     would seem to be useful, the rationale of the comparative study is to try to identify, in~     compliance with the protocol of Helsinki (2013), the most effective short-term treatment for~     the disappearance of pain in defecation and cessation of bleeding, shortening the duration of~     the healing process and favoring the patient's rapid return to his / her activity, respect~     for patient safety.~   "
16128|NCT03355833|"~     In 2016, the Third International Consensus proposed a new strategy to screen aggravating risk~     in patients with septic shock. This strategy is based on quick-SOFA and the SOFA score. The~     main objective is to compare the prognostic performance of SEPSIS 3 against the previous~     strategy SEPSIS 2 to predict the admission in intensive care unit or the intra-hospital~     death.~   "
16129|NCT03355820|"~     The purpose of this study is to evaluate the persistence of immune response in subjects who~     received the HPV-16/18 vaccine, seven to eight years after the last dose of primary~     vaccination in the HPV-058 study. No new subjects will be enrolled in this extension study.~   "
16130|NCT03355807|"~     The purpose of this study was to investigate the effect of magnesium sulfate on pain~     management for pain after sleeve gastrectomy operation~   "
16154|NCT03355495|"~     Colonoscopy continues to be the gold standard in detecting precancerous lesions in the colon.~     It relies on adequate visualization of the bowel wall to see and remove such lesions.~     Visualization is improved with luminal distention, and a multitude of studies have been done~     to determine ways to increase this luminal distention. The investigators theorize that~     positioning in the Right Lateral Decubitus rather than the Left Lateral Decubitus may be a~     cost free method to increase luminal distention and, hence, improve visualization in~     colonoscopy. In the Right Lateral Decubitus position, the sigmoid colon and cecum - both~     parts of the bowel that are not fixed - air used during colonoscopy will rise in a dependent~     fashion, increasing luminal distention. In the left lateral decubitus position, the bowel~     collapses, creating an often difficult area to maneuver and visualize. The investigators~     would like to compare both positions to determine if it affects outcomes in colonoscopy. In~     particular, cecal intubation rates and adenoma detection rates.~   "
16131|NCT03355794|"~     In this research study, we want to learn about the safety of the study drugs, ribociclib and~     everolimus, when given together at different doses after radiation therapy. We also want to~     learn about the effects, if any, these drugs have on children and young adults with brain~     tumors.~      We are asking people to be in this research study who have been diagnosed with a high grade~     glioma, their tumor has been screened for the Rb1 protein, and they have recently finished~     radiation therapy. If a patient has DIPG or a Bi-thalamic high grade glioma, they do not need~     to have the tumor tissue screened for the Rb1 protein, but do need to have finished radiation~     therapy.~      Tumor cells grow and divide quickly. In normal cells, there are proteins that control how~     fast cells grow but in cancer cells these proteins no longer work correctly making tumor~     cells grow quickly. Both study drugs work in different ways to slow down the growth of tumor~     cells. The researchers think that if the study drugs are given together soon after radiation~     therapy, it may help improve the effect of the radiation in stopping or slowing down tumor~     growth.~      The study drugs, ribociclib and everolimus, have been approved by the United States Food and~     Drug Administration (FDA). Ribociclib is approved to treat adults with breast cancer and~     everolimus is approved for use in adults and children who have other types of cancers. The~     combination of ribociclib and everolimus has not been tested in children or in people with~     brain tumors and is considered investigational.~      The goals of this study are:~        -  Find the safest dose of ribociclib and everolimus that can be given together after~          radiation.~        -  Learn the side effects (both good and bad) the study drugs have on the body and tumor.~        -  Measure the levels of study drug in the blood over time.~        -  Study the changes in the endocrine system that may be caused by the tumor, surgery or~          radiation.~   "
16132|NCT03355781|"~     Childhood trauma is known as a vulnerability factor in schizophrenia. In healthy volunteers,~     these adversities are linked to a decrease of grey matter of the brain, similar to those~     observed in schizophrenia.~      In a previous study based on Voxel-Based Morphometry (VBM), including 21 schizophrenic~     patients and 30 healthy volunteers, the investigators shown a negative correlation between~     emotional neglect (important dimension in childhood trauma) and grey matter decrease. This~     strong correlation was significantly higher in schizophrenic patients than in healthy~     volunteers, suggesting a higher genetic predisposition to environmental factors in~     schizophrenic people.~      Currently, interaction between genetic predisposition and environmental stress factors is the~     major model for understanding in schizophrenia. In order to analyze both effects on human~     body, particularly on brain, several studies currently focus on the product of genetic~     expression, the ribonucleic acid (ARN).~      The purpose of this study is to provide an explanatory model of links between childhood~     trauma, candidate gene for schizophrenia expression, cerebral morphology and schizophrenic~     symptomatology. Using conceptual framework of stress vulnerability, structural equation~     modeling (SEM) will allow testing causal link between these different variables.~   "
16133|NCT03355768|"~     This study employs a 1:1 randomization of patients to receive romidepsin alone verses~     romidepsin plus pralatrexate for the treatment of patients with relapsed or refractory~     peripheral T-cell lymphoma (PTCL). The primary objectives will be to identify a 75%~     improvement in progression free survival (PFS) among patients receiving the combination~     compared to single agent romidepsin.~   "
16134|NCT03355755|"~     A safety and feasibility study of robotic exoskeleton training in deconditioned patients~     residing in a healthcare facility.~   "
16135|NCT03355742|"~     XIENCE 28 Global Study is a prospective, single arm, multi-center, open label, non-randomized~     trial to further evaluate the safety of 1-month (as short as 28 days) dual antiplatelet~     therapy (DAPT) in subjects at high risk of bleeding (HBR) undergoing percutaneous coronary~     intervention (PCI) with the approved XIENCE family (XIENCE Xpedition Everolimus Eluting~     Coronary Stent System [EECSS], XIENCE Alpine EECSS, XIENCE PROX EECSS, or XIENCE Sierra EECSS~     of coronary drug-eluting stents~   "
16136|NCT03355729|"~     The Quebec Family Study (QFS) is an observational study that was planned to investigate the~     role of genetic factors in physical fitness, body composition, risk factors for common~     disease and health-related behaviour.~   "
16137|NCT03355716|"~     compare the analgesic efficacy of the combination of bupivacaine and morphine, bupivacaine~     and fentanyl and bupivacaine and ketamine in alleviating post operative pain following~     laparoscopic cholecystectomy.~   "
16138|NCT03355703|"~     Odontoid fracture is a common fracture accounting for 10-15% of all cervical fractures. It~     occurs in bimodal fashion in elderly and young patients.~      The classification of Anderson and Alonzo provides a guide for prognosis . Type I and type~     III have a good rate of union, while type II has a poor prognosis due to poor blood supply.~     Hence, operative fixation is recommended to avoid non-union.~      Treatment options for type II include anterior odontoid screw fixation and posterior C1-C2~     fusion.Despite the excellent rates of bony union in posterior C1-C2 fusion, it is associated~     with higher morbidity, higher blood loss and significant limitation in the range of motion~     and rotation of the neck.the aim of the study Is to evaluate clinical and radiological~     outcome of anterior odontoid screw osteosynthesis in treatment of type 2 odontoid fracture.~   "
16139|NCT03355690|"~     A stroke occurs when the blood circulation is hampered due an ischemic or hemorrhagic event.~     Previous, a stroke was treated only with anti-aggregation. Over time, multiple studies have~     showed a positive effect of intravenous thrombolysis with rt-PA (recombinant tissue~     plasminogen activator) in comparison with the standard treatment (anti-aggregation). Since~     2015, thrombectomy was proven to have an added value in combination with thrombolysis.~     Thrombectomy is an endovascular technique where the thrombus is removed or fragmented.~      Diagnosis and treatment of stroke will have a significant impact on the health-economic~     status of the patient. However, little data is known. Unfortunately, the outcome after~     diagnosis with a stroke is not well documented. Therefore, this follow-up study over a time~     period of one year, will give us a sufficient amount of data to evaluate patients diagnosed~     with a stroke in the hospital of Genk.~   "
16155|NCT03355482|"~     This is an exploratory evaluation of MRI as a reliable, sensitive, and accurate outcome~     measure for clinical trials in SLE arthritis. Forty patients with SLE and moderate to severe~     synovitis (minimum of 3 tender and 3 swollen joints in wrists and hands) will be randomized~     to new or increased methotrexate therapy plus a single injection of Depomedrol or a matched~     placebo at baseline. Methotrexate will be injected subcutaneously once per week at ascending~     doses. The study will evaluate a range of outcomes discernable by MRI at 3 months and 6~     months after baseline. We will also compare MRI findings, clinical endpoints, and biomarker~     changes in patients that were treated with Depomedrol vs. matched placebo at baseline.~   "
16165|NCT03355352|"~     The observational study will check if there is a difference in the postoperative care of~     patients with urogenital intervention while using the standard PCA-syringe pump or using the~     Zalviso sufentanyl sublingual analgetic system.~      The study will exactly examine, using questionaire for the patient, the medical stuff (nurses~     and anesthesiologist) the difference in the analgetic quality, the difference of the~     patients` mobility while being treated with one of the analgetic system and if there is a~     difference in the cost-efficiency.~      We want to examine 50 Patients in each group. The studies should be finished in about one~     year.~   "
16140|NCT03355677|"~     Chronic Obstructive Pulmonary Disease (COPD) is a disease of the lungs which is generally~     caused by smoking tobacco. It is a largely preventable disease that causes severe and~     irreversible damage to the lungs. If not detected early, this damage will progress causing~     significant breathing difficulties, disability and poor survival rates. Patients with COPD~     can experience exacerbations of their disease which can also lead to can be described as a~     worsening of the patients symptoms COPD is a global health concern and it is estimated to~     become the third leading cause of death by 2020. In the United Kingdom, around 900,000 people~     have a formal diagnosis of COPD. However, it is believed that over 2 million more people may~     be living with the disease and are unaware that they have it. The cost of treating lung~     disease in the National Health Service (NHS) is estimated to be approximately £4.7billion per~     year . The majority of these costs are caused by a small group of COPD patients with severe~     disease and complex problems , . Late diagnosis has been proven as a contributing factor to~     the worsening of COPD, disease progression and increased healthcare costs. Indeed, recent~     research has shown that patients may attend their general practitioner (GP) practice with~     signs of the disease up to five years before they have the condition diagnosed. A delay in~     diagnosis is known to hasten the decline in lung function and worsen disease severity making~     treatment options less useful in the long term. This has led to national guidelines~     recognising that patients with COPD need to be diagnosed and treated effectively at the~     earliest opportunity.~      The aim of this study is to find the best way to identify or 'case find' patients who have~     not yet been diagnosed with COPD, and also identify patients with more complex disease using~     a computerised search programme. The study will examine whether this intervention has saved~     the NHS money by reducing GP and hospital visits and by decreasing rescue medicine usage for~     respiratory problems, by comparing this data to similar GP practices where the intervention~     had not been implemented. Once patients have been identified, they will be invited to attend~     a clinic appointment at their GP practice to participate in a tailored intervention programme~     for patients at risk of having COPD and those with existing complex COPD. GP practices will~     also be offered a training package in order to continue the intervention programme in the~     future.~   "
16141|NCT03355664|"~     This study is a multi-centre, open-label randomised trial to assess the efficacy, safety and~     tolerability of the Triple ACT artemether-lumefantrine+amodiaquine (AL+AQ) compared to the~     ACT artemether-lumefantrine (AL) in uncomplicated falciparum malaria in Cambodia and Vietnam.~     The estimated total sample size is 600 patients from 2 sites in Cambodia and 2 sites in~     Vietnam. There are 2 treatment arms Arm 1: Artemether-lumefantrine for 3 days Arm 2:~     Artemether-lumefantrine for 3 days plus Amodiaquine for 3 days. According to the World Health~     Organization guideline, all patients except children under 10 kilograms will also be treated~     with a single dose of primaquine as a gametocytocidal treatment.~   "
16142|NCT03355651|"~     This was a prospective, multicenter, randomized, open-label, phase IV trial to compare the~     efficacy of supplementation with plasma proteins, hydrolyzed collagen (CH), a complex of~     HA-CS (HC-15), and vitamin C combined with a standard rehabilitation protocol versus the~     standard rehabilitation protocol only after arthroscopically-assisted functional ACL~     reconstruction with hamstrings.~   "
16143|NCT03355638|"~     To determine whether a combination of intravitreal aflibercept and pranoprofen eyedrops or~     nutraceutical support provides additional benefit over IVA monotherapy for the treatment of~     choroidal neovascularization in age-related macular degeneration.~   "
16144|NCT03355625|"~     The primary aim is to describe platelet function in adult patients treated with~     extracorporeal membrane oxygenation (ECMO). A clarification of the platelet function in these~     critically ill patients contributes to an understanding of the mechanisms underlying their~     coagulopathy.~      The present study is a substudy to the study entitled; Coagulopathy During Extracorporeal~     Membrane Oxygenation (pending Clinical Trial ID number).~   "
16145|NCT03355612|"~     This is a randomized, multicenter, controlled study to compared the Efficacy and Safety of~     XELOX combined with Apatinib versus XELOX as post-operative chemotherapy in locally advanced~     gastric signet ring carcinoma with D2 dissection.~   "
16146|NCT03355599|"~     The study will explore whether a 3D camera data can provide a more accurate baseline~     measurement (compared to 2D images with manual measurement) to support better clinical~     decision making in referrals to tissue viability.~   "
16147|NCT03355586|"~     In this clinical trial we will investigate the diagnostic yield of a combination of~     commercially available imaging and navigation techniques for reaching peripheral lung~     lesions. The two investigated techniques will herein be the rEBUS imaging modality combined~     with electromagnetic based navigation. Confirmation of reaching the lung lesion will be by~     means of CT (fluoroscopic) imaging. Rapid On‐Site Evaluation (ROSE) of cytopathology will be~     used for obtaining a per‐procedural outcome on tissue biopsy representativeness. All data~     will be prospectively collected. In case tissue biopsy is found to be malignant or benign, it~     will be termed representative. In case tissue biopsy is found to be non‐representative~     (=blood, anatomical lung tissue, unreachable), conventional followup of CT guided TTNA,~     follow‐up monitoring and/or surgical biopsy will serve as golden standard for obtaining~     tissue diagnosis. For verification of reaching the target lesion, another study parameter of~     interest, (cb)CT imaging will be performed for verification that instruments are within the~     nodule (per‐procedurally available).~   "
16148|NCT03355573|"~     This is a study to assess the long term safety and tolerability of bimekizumab in subjects~     with ankylosing spondylitis~   "
16149|NCT03355560|"~     The purpose of this research study is to test the safety and efficacy of nivolumab after~     salvage resection in head and neck cancer in patients that have previously received~     definitive radiation with or without chemotherapy.~   "
16150|NCT03355547|"~     Pediatric patients between 6months and 6years old will be included. They are scheduled for~     elective general or urologic surgery at a single thetiary medical center. Before the~     operation, the researcher interviews the parents of the pediatric patients to check whether~     they have the upper respiratory tract infection and asks them to fill out a questionnaire~     about the severity of their symptoms. The researcher will get the symptom score of the upper~     respiratory tract infection in the questionnaire. The degree of anesthesia indeced~     atelectasis is measured using lung ultrasound. Pulmonary ultrasound is performed after~     endotracheal intubation and at the end of the operation dividing the patient's thorax into 12~     regions. The investigator grades the degree of atelecatisis at each region form 0 to 3~     points. After the end of the operation, check whether the respiratory adverse effects~     occurred during emergence and recovery at the post anesthesia care unit.~   "
16151|NCT03355534|"~     Dexmedetomidine induces analgesic and sedative effects and is reported to decrease agitation~     during emergence after general anesthesia in various surgeries. For patients undergoing~     cranial aneurysm surgeries, a calm anesthesia and emergence is important. In this study, the~     investigatorstend to observe the effect of dexmedetomidine on maintenance and recovery of~     patients undergoing cranial aneurysm surgeries.~   "
16316|NCT03353389|"~     This retrospective cohort study aims to investigate the incidence, risk factors and outcomes~     of Hospital-acquired Acute Kidney Injury in Hospital Selayang, a tertiary hospital at~     Malaysia, over 15 years.~   "
16156|NCT03355469|"~     Health organizations recommend exercise in an intensity based manner to promote~     cardiovascular adaptation and prevent disease. Metformin is a common anti-diabetes medication~     that reduces future type 2 diabetes and cardiovascular disease (CVD) risk. However, the~     optimal dose of exercise to be combined with metformin for vascular health remains unknown.~     The purpose of this study is to evaluate whether combining high or low intensity exercise~     with metformin has the potential to outperform either exercise intensity alone on blood flow~     across the arterial tree as well as impact insulin action in individuals with metabolic~     syndrome. Identification of such outcomes will indicate 1) whether and how metformin should~     be combined with physical activity for CVD prevention, 2) provide the first indication of~     whether exercise intensity reduces CVD risk via multi-level vasculature function vs.~     metabolic insulin action, and 3) provide a rational early treatment for people with metabolic~     syndrome to prevent/treat type 2 diabetes and CVD.~   "
16157|NCT03355456|"~     A three-pronged approach to evaluate long term success of non-paroxysmal ablation when using~     a:~        1. specified low voltage-directed with pulmonary vein isolation (LD+PVI) approach compared~          to ,~        2. empiric posterior wall isolation with pulmonary vein isolation (PW+PVI) approach~          compared to~        3. an approach of pulmonary vein isolation (PVI) alone.~   "
16158|NCT03355443|"~     The primary aim of this study is~      - to explore the usefulness of re-examination and retroflexion on adenoma miss rate (AMR) in~     the proximal colon.~      Other aims include to explore the data below when re-examination or retroflexion is used.~        -  Adenoma detection rate, ADR~        -  Polyp miss rate, PMR~        -  Polyp detection rate, PDR~        -  Withdrawal time, WT~   "
16159|NCT03355430|"~     The investigators aim to investigate the effects of combined corneal wavefront-guided~     transepithelial photorefractive keratectomy (tPRK) and accelerated corneal collagen~     cross-linking (CXL) after intracorneal ring segment (ICRS) implantation in patients with~     moderate keratoconus. Medical records of 23 eyes of 23 patients undergoing combined tPRK and~     CXL after ICRS implantation were retrospectively analyzed. Uncorrected distance visual acuity~     (UDVA), corrected distance visual acuity (CDVA), manifest refraction spherical equivalent~     (MRSE), corneal indices based on Scheimpflug tomography, higher-order aberrations (HOAs), and~     corneal biomechanical properties were evaluated before and after ICRS implantation, and at 1,~     3, and 6 months after combined tPRK and CXL. Corneal biomechanical properties were measured~     using the dynamic Scheimpflug analyzer at approximately the same time of day.~   "
16160|NCT03355417|"~     The investigators hypothesize that children completing 30 sessions of occupational therapy~     using a sensory integration approach (OT-SI) will demonstrate positive changes in outcome~     measures related to motor coordination, functional performance and sensory processing~     (changes pre-post test).~   "
16161|NCT03355404|"~     For 25 years, the concept of Rapid Rehabilitation After Surgery or RRAC has developed to~     bring about a global care of the patient by establishing a safe and quality climate. With~     this concept of RRAC or fast track surgery, it is the idea that a patient will recover sooner~     than he is lying later. Fast care is based on the principle that any patient is valid~     before he / be operated and therefore do not need to come to a bed in the operating room.~      The ambulatory surgery department of the CHU of Caen welcomes and supports adults and~     children over 8 years old. The following specialties are covered: dental surgery and~     stomatology, digestive and visceral surgery, orthopedic surgery, otolaryngological surgery,~     vascular surgery, gynecological surgery, urological surgery. The ambulatory surgery unit is~     experimenting with patient support at the operating theater on foot by the service stretcher~     team since December 2015. It seems that this technique makes it possible to improve the~     quality of care by respecting the dignity and autonomy; in fact to wander the patient~     preserves his glasses, his hearing aids, capillary prosthesis ... The patient is an actor and~     not dependent, he is accompanied and not taken away. The preservation of autonomy improves~     their feelings, especially in terms of dignity. It also appears to be a technique for~     participating in the reduction of preoperative anxiety, an important factor for postoperative~     follow-up.~      However, studies reporting the benefit of this technique have rather evaluated the feelings~     of patients. To the best of our knowledge, there are no studies that have evaluated their~     benefit on anxiety reduction by questionnaires or ad hoc scales. Assessing anxiety with~     appropriate tools seems essential to determine a real impact.~      We hypothesize that accompanying the patient to the operating room on foot would reduce~     preoperative anxiety. We have not yet found any studies showing that the standing patient~     pathway had an impact on preoperative anxiety. We propose to carry out a randomized study~     comparing the anxiety score using the APAIS scale at the operating room installation between~     patients benefiting from the standing patient pathway versus the patients receiving the~     care standard, that is to say the stretcher transport to the operating theater.~      The duration of this study is evaluated at 2 years.~   "
16162|NCT03355391|"~     Colorectal cancer (CRC) is the third most common type of cancer among men and the second~     among women in Brazil. Despite the high incidence and significance of CRC in Brazil, very~     little is known about its prevalence among the asymptomatic population. Recently, a CRC~     screening program was implemented at the Cancer Hospital of Barretos. Characterization of the~     clinical findings detected in the screening population and the prevalence of basal CRC might~     contribute to better organization of the program and define the best strategy for a future~     national screening program. We hypothesize that recruitment and the early outcomes of our~     screening program based on the fecal immunochemical test (FIT) will differ from the outcomes~     corresponding to other populations due to sociodemographic differences. Aims: i. To implement~     a data collection and storage system for follow-up of the screening program participants and~     to measure early outcomes (adenoma, advanced adenoma and cancer) and associate them with~     sociodemographic risk factors; ii. to quantify the risk of CRC in the Brazilian population~     and to develop algorithms for risk stratification of CRC screening; and iii. to compare the~     risk stratification to other countries with low, medium and high incomes. Methods:~     Individuals aged 50 to 65 years will be included in the HCB screening program from November~     2017 to December 2018. The following data will be collected from all participants:~     sociodemographic and ethnic (skin color) characteristics; risk factors for CRC, such as~     smoking and drinking; comorbidities, including diabetes mellitus and arterial hypertension;~     and FIT, colonoscopy and histopathology examination results. Data collection will be~     performed using the REDCap data collection/database system. The risk score will be formulated~     using the Chi-square test (or Fisher's exact test) and simple logistic regression, and the~     regression coefficients will be calculated. Then, the model identified for the training~     sample will be replicated with a validation sample. The resulting score will be used to~     calculate the sensitivity, specificity, positive predictive value, negative predictive value,~     accuracy, area under the receiver operating characteristic (ROC) curve and Kolmogorov D~     statistic.~   "
16163|NCT03355378|"~     After major open abdominal surgery, transient paralytic ileus usually follows. It has been~     suggested that stimulation of pain fibers, excessive sympathetic tone, and the release of~     inhibitory neurotransmitters from bowel wall associated with bowel manipulation and~     peritoneal irritation are responsible mechanisms. There have been concerns that early~     postoperative oral feeding would lead to vomiting with subsequent aspiration pneumonia,~     anastomotic leakage, and wound dehiscence.~   "
16164|NCT03355365|"~     This is a Phase II, Double-Blind, Placebo-Controlled, Randomized, Cross-over Study designed~     to determine efficacy of multiple intrathecal administrations of autologous mesenchymal stem~     cell-derived neural progenitor cells (MSC-NP) compared to placebo in patients with~     progressive multiple sclerosis. Efficacy will be measured through assessment of disability~     outcomes. Study participants will receive six intrathecal injections of culture-expanded~     autologous MSC-NPs at two month intervals in one year and six lumbar punctures as placebo~     treatment in a second year.~   "
16167|NCT03355326|"~     Gastroschisis is a congenital defect of the abdominal wall that leads to evisceration of~     various amounts of the abdominal organs. The mainstay of therapy is restoring continuity of~     the abdominal wall, either through primary closure or with a synthetic graft when primary~     closure is not feasible.~      It has been established that bowel function after repair of gastroschisis is impaired due to~     the aforementioned pathological processes. Previous studies have shown that the time from~     surgery to attaining full nutrition through enteral means is a predictor for morbidity in~     this population. Therefore, numerous therapeutic interventions have been proposed to help~     hasten bowel function and decrease the time to tolerance of total enteral nutrition. A~     common, but unproven, technique is the use of glycerin suppositories to stimulate bowel~     function. The concept of glycerin suppositories is that stimulating colonic activity through~     the use of the suppository will stimulate small intestinal function. The underlying concept~     is that improved bowel motility and reduced time to full enteral feeds will reduce the~     morbidity associated with this disease. While the formation/evacuation of stools is most~     easily monitored, the main purpose of using these suppositories is to hasten tolerance of~     nutrition through enteral means.~      While the practice of using glycerin suppositories is common in neonates, there is no~     literature or best-practice guidelines advocating for (or against) their use. A single~     previous prospective study utilizing glycerin suppositories in premature, low birth weight~     neonates failed to show any benefit in improving time to tolerate full enteral feeds. At this~     time, this is the only study investigating the use of glycerin suppositories in any neonatal~     population, and due to the indications (i.e. premature and low birth weight infants without~     surgical disease), the findings are not applicable to neonates with gastroschisis. To the~     authors' knowledge, there are no previous studies or current ongoing studies examining this~     question. Given this lack of information regarding the efficacy of glycerin suppositories,~     there is a significant variation in practice among practicing surgeons, including timing of~     initial administration, frequency of use, and indication to discontinue. Indeed the spectrum~     ranges from some surgeons who never use glycerin suppositories, to some who prescribe them~     daily for all gastroschisis patients immediately following surgery.~      The purpose of this study will be to determine whether routine use of glycerin suppositories~     improves bowel function as measured by time to full enteral feeds (primary outcome: defined~     as enteral feed volume >120mL/kg/day with appropriate weight gain (20-30g/day for two~     consecutive days)) in neonates with uncomplicated gastroschisis after complete reduction of~     abdominal viscera. Secondary outcomes include time to first bowel movement and~     incidence/severity of TPN-induced cholestasis in the study groups.~   "
16168|NCT03355313|"~     Malnutrition is a clinical-social disease caused by multiple prenatal, intrauterine and~     postnatal factors as well as social, political and cultural determinants (distal causes).~     Despite the global and national reductions in the number of cases, malnutrition continues to~     be a public health problem, with greater prevalence in pockets of poverty found in the~     northern and northeastern regions of Brazil.~      Episodes of malnutrition in early childhood, with consequent calcium, phosphate and vitamin~     A, C and D deficiencies, can increase one's susceptibility to dental caries through three~     probable mechanisms: defects in tooth formation (odontogenesis), delayed tooth eruption and~     alterations in the salivary glands.~      It is likely that the significant increase in susceptibility to caries in malnourished~     individuals stems from alterations in the salivary secretion rate, since a reduction in~     salivary flow (salivary gland atrophy) increases the susceptibility to both dental caries and~     dental erosion. As saliva is the main defense factor of the oral cavity, a reduction/change~     in its physical properties (secretion rate and buffering capacity) can cause immunological~     disorders that affect an individual's defense capacity.~      Studies have demonstrated that salivary immunoglobulin A (IgA) also plays an important role~     in the immunity of the oral mucosa. Indeed, patients with IgA deficiency can experience~     recurring upper airway (tonsillitis, ear infection and sinusitis), lower airway (pneumonia)~     and gastrointestinal (diarrhea and parasitosis) infections.~      The investigation of mechanisms that can reduce the impact of malnutrition on the defenses of~     the organism is of the utmost important and interest to public health. Among such mechanisms,~     low-level laser therapy has demonstrated effectiveness in the treatment of diverse conditions~     and disease through the promotion of the biomodulation of the cell metabolism and due to its~     analgesic and anti-inflammatory properties with no mutagenic or photothermal effects.~   "
16169|NCT03355300|"~     The primary purpose of this study is to assess the long-term safety and tolerability of~     Cannabidiol Oral Solution (CBD) in pediatric participants with treatment-resistant childhood~     absence seizures.~   "
16170|NCT03355287|"~     To assess the impact of soil iron intake from teff flour on iron status in infants in Debre~     Zeit, Ethiopia.~   "
16171|NCT03355274|"~     The measurement of the transcutaneous oxygen partial pressure (TCPO2) at exercise is, to our~     knowledge, the only method to estimate during the exercise the importance of ischemia segment~     of limb by segment of limb bilaterally and carry on. The diagnosis of thoracic outlet~     syndrome causing remains difficult and dependent operator in ultrasound because of the risk~     of false positive (loss of signal) or false negative (insufficient effort, inappropriate~     movement).~      Our main hypothesis is the existence of significant measurable ischemia in the forearm by~     transcutaneous oximetry during the maneuvering of the candlestick.~      In the event of failure of this maneuver, the other maneuvers such as those of Wright, Roos,~     Tinel and Adson will be realized.~      In this study we want to evaluate the possibility of using dynamic transcutaneous Oximetry as~     a tool for evaluating ischemia in case of suspicion of thoracic outlet syndrome causing.~   "
16172|NCT03355261|"~     To investigate the regression model of positive nodes after neoadjuvant chemotherapy (NAC) by~     injecting and tracing carbon nanoparticles (CNs) in fusion node prior to NAC in patients with~     breast cancer.~   "
16173|NCT03355248|"~     Presently, the standard of care at the investigators' practice is that the discharging~     physician decides the type and amount of opioid medication to prescribe a patient following a~     cesarean section. After informed consent has been obtained, patients will be enrolled in this~     randomized-controlled equivalence study. The experimental group will be prescribed 20~     oxycodone-acetaminophen and the control group will be prescribed 28 oxycodone-acetaminophen~     at the time of discharge. Both groups will also be provided with a handout on non-opioid~     analgesia. The groups will be assigned randomly in blocks. The investigators will recruit~     patients either in the clinic, if participants are to have a scheduled cesarean section, or~     at some time during the hospital admission for delivery. The satisfaction survey and pain~     scale will be administered at the postoperative check by the clinic staff and providers.~     These surveys will be stored in a secure location at the clinic. If the patient does not show~     up for their postoperative visit, 3 attempts total will be made by an investigator to reach~     the patient and administer both surveys by phone within 2 weeks of discharge. A preliminary~     analysis of the data will be done once half the study patients have been recruited. The~     investigators do not foresee any threats to the external or internal validity of the study.~     The investigators are taking many measures to limit study bias. First, block randomization~     will help limit discrepancies between groups. Also, strict adherence to the inclusion and~     exclusion criteria will also help limit confounders that may make data difficult to~     interpret, such as non-opioid naïve patients and complications that may potentially increase~     pain and opioid requirements. Lastly, blinding of patients to the number of pills~     participants receive will help mitigate patient bias.~   "
16174|NCT03355235|"~     The overall objectives in this study are to identify patterns of cognitive impairment pre-~     and post-transplant, to assess the similarities of scores of the three cognitive assessments~     in myeloma patients who undergo autologous stem cell transplant, and to determine if patients~     prefer the self-assessment, Self-Administered Gerocognitive Exam (SAGE) or the healthcare~     applied Montreal Cognitive Assessment (MoCA) assessment.~   "
22661|NCT03270371|"~     This study examines whether medium-cut off dialysis results in improved blood purification of~     large middle molecules e.g. inflammatory molecules compared to hemodialysis (HD) treatments~     with conventional high-flux dialyzers.~   "
16175|NCT03355222|"~     Mothers and young children in rural Ethiopia lack sufficient nutrition, and a compounding~     factor is presence of high levels of fluoride (> 5-10 mg/day) affecting body functions.~     Interventions involving chickens to provide eggs and eggshell (a source of calcium) are one~     solution. The overall purpose is to examine how increasing dietary calcium by using eggshell~     powder (ESP) reduces fluoride (F) absorption in women. It is known calcium binds F to prevent~     its absorption but application of this to a community based study has not been tested. The~     aim is to provide chickens to produce eggs for young children and to provide ESP to women~     (mothers). For children, an egg a day should improve growth and nutritional status. For~     women, the ESP provides calcium to reduce fluorosis and therefore improve function without~     affecting iron and zinc status. For the women, blood samples will be tested in a subsample~     for F, calcium, zinc and iron; urine samples will be measured for F, calcium and creatinine~     (to correct spot urine). Hemoglobin will be measured as an indicator of overall nutritional~     status in women and children. Nutritional status of young children (6-18 mo) and of their~     mothers prior and after the intervention (by 6 months) will be assessed. between 6 and 12~     month there will be monitoring for sustainability of chilckens in the community; for~     continued use of egg (in children) and ESP (in women); during this time the control group~     will receive chickens and also undergo monitoring. The study will take place in the Rift~     valley of Southern Ethiopia. Identification of the knowledge, attitude and practices (KAP) of~     mothers on egg consumption will be done at baseline and at the end (endline). Caregivers~     will be instructed to give each child 1 egg (cooked) per day in the intervention, and one~     bottle cap of eggshell powder (1000 mg calcium) per day for themselves. Families receiving~     chickens will be instructed on cage construction. Throughout the study, any problems arising~     in keeping chickens will be recorded in order to assess the feasibility and practicality of~     raising chickens as way to mitigate fluorosis and improve nutritional status.~   "
16176|NCT03355209|"~     This is a two-part, multicenter, double-blind, parallel-group, placebo controlled study to~     evaluate the effect of ZX008 when used as adjunctive therapy for the treatment of~     uncontrolled seizures in children and adults with Lennox-Gastaut syndrome (LGS).~   "
16177|NCT03355196|"~     This study is designed to evaluate, for the first time in humans, safety and tolerability of~     single ascending doses of intra-articular (i.a.) injections of LRX712 into the knee of~     patients with moderate osteoarthritis (OA), in order to support the further clinical~     development. This study will also allow establishment of the systemic and local~     pharmacokinetics (PK) of LRX712 and the exploration of biomarkers of cartilage breakdown and~     regeneration in OA patients.~   "
16178|NCT03355183|"~     The aim of this study is to determine the repetition numbers of the peak force value~     generated during isokinetic knee flexion and extensor movement evaluation at 60 and 180 °/~     sec angular velocities and to identify the factors associated with this repetition.~   "
16179|NCT03355170|"~     The aim of current study is to compare safety and efficacy of lansoprazole/domperidone 30/30~     mg sustained release capsules (brand name: Duolans) and lansoprazole 30 mg micropellet~     capsules (brand name: Lasotab) in GERD patients in terms of cardiac safety.~   "
16180|NCT03355157|"~     The goal of the study for patients with metastatic breast cancer (MBC) is to show that~     palbociclib + endocrine therapy shows a significant improvement in time-to-treatment failure~     over chemotherapy regimen (mono-chemotherapy with or without endocrine therapy). This would~     provide level 1 evidence from real world that palbociclib plus endocrine therapy is the first~     choice in MBC patients needing first-line therapy not only compared to endocrine therapy but~     also compared to chemotherapy with or without endocrine maintenance therapy.~      In addition, we assume that patient-reported outcome as measured by FACT-B and a novel~     composite endpoint of well-being and healthcare utilization (DMTI) will be improved with~     palbociclib + endocrine treatment vs. chemotherapy regimen.~   "
16181|NCT03355144|"~     Coffee drinking is frequently reported as a negative outcome in studies on burnout, but the~     effect of an increased coffee intake on resident burnout has not been reported in the~     literature. This study is a prospective, interventional cohort study enrolling up to 50~     residents from the Internal Medicine Residency Program to look at the relationship between~     coffee and resident burnout.~   "
16182|NCT03355131|"~     This study assessed the effect of the National Aeronautics and Space Administration's~     (NASA's) Mission X (MX) program on children's knowledge, attitude, and practice of healthy~     eating and active living (HEAL) and weight status in rural elementary schools in Taiwan.~   "
16183|NCT03355118|"~     This clinical observational study investigates perioperative oxygen consumption and delivery~     in elderly patients undergoing major surgery. The primary objectives are to characterise the~     perioperative oxygen delivery, consumption and potential markers of oxygen debt. Secondary~     objective is to estimate the correlation between oxygen delivery/consumption and~     postoperative outcomes to guide the design of a future trial.~   "
16184|NCT03355105|"~     In the context of neuromuscular diseases, the weakness of the respiratory muscles makes~     difficult to manage periods of congestion due to a less effective cough. It exposes the~     patient to bronchial superinfections that may require hospitalization. The use of cough~     assistance is therefore essential in order to avoid acute situations such as bronchial~     superinfections. Mechanical Insuflation-Exsufflation (MI / E) is an instrumental technique~     commonly used by therapists in a hospital or at the patient's home in order to facilitate the~     airway mucus clearance. The choice of the pressure settings of the IM / E is a decisive point~     because it conditions the effectiveness of the generated cough. It'is important to take into~     account the presence of any collapse in the use of IM / E in order to ensure the most~     effective cough given by the patient. Actually, except the common impression of the~     physiotherapist and the patient, there is no simple way for detecting and objectifying the~     threshold of collapse in the upper airways.~      The aim of this study is to compare two modalities for the regulation of the level of the~     MI-E exsufflation, taking into account the presence of a collapse: a subjective S~     adjustment based on the clinical judgment of the therapist and the patient and an objective~     O adjustment based on the flow-volume curve generated during the cough.~   "
16185|NCT03355092|"~     Overall aim: To demonstrate that weight loss through vBloc Therapy in combination with usual~     care will achieve better glycemic control for patients with obesity and type 2 diabetes than~     usual care alone.~      Duration: Participants will be asked to participate in a 12 month study that involves a~     baseline visit and research follow-up visits at 3, 6, 9, and 12 months.~      Sample Size: 60 participants will be enrolled in the study. Of these, 30 will be randomized~     to vBloc therapy and 30 will be randomized to usual care.~   "
16186|NCT03355079|"~     The purpose of this study is to determine the efficacy of long-term addition of SmofKabiven®~     E to normal oral nutrition after routine dietary counseling. It takes place in lung cancer~     patients under chemo- and/or immunotherapy. Efficacy will be determined primarily by~     calculating the change of patient's body weight from before start of study treatment to end~     of treatment, and comparing this change between both treatment groups.~   "
22672|NCT03270228|"~     The investigators want to determine the incidence of malignant disease, type of malignant~     disease and overall survival in patients diagnosed with NSP after VATS.~   "
16187|NCT03355066|"~     This study is an open-label, multi-center, dose-escalation study in adult subjects with~     advanced solid tumors for whom standard therapy is not available for their stage of disease.~     The study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics~     (preliminary anti-tumor activity and gene expression analysis) of SM08502 administered~     orally, once daily, for 28 consecutive days. Dosing in 28-day cycles will continue within~     each subject, up to 6 cycles total, unless the subject is withdrawn from the study for one of~     many different reasons.~   "
16188|NCT03355053|"~     Sleep deprivation is common and severe in critically ill patients cared for in intensive care~     units (ICUs), and is hypothesized to be a key modifiable risk factor for delirium and~     long-term cognitive disability. Dexmedetomidine reduces the incidence of delirium in ICU~     patients by unknown mechanisms. This project will determine whether dexmedetomidine reduces~     delirium by improving sleep, whether bolus dosing vs continuous infusion is better, and the~     relationship of sleep quality to long-term cognitive outcomes.~   "
16189|NCT03355040|"~     A french study published in 2015 (DAME) showed a decrease of shoulder dystocia and an~     increase of spontaneous vaginal delivery when the non insulin-treated diabetes patients with~     large-for-date fetus were induced.~      This new protocole was introduced in Montpellier University Hospital delivery room.~      The aim of this study is to evaluate the protocole in Montpellier hospital and to compare our~     results with the DAME results.~   "
16190|NCT03355027|"~     The INTENSITY-HIGH study aims to answer if there are any limits to LDL reduction in relation~     to benefiting vascular health, exploring the mechanisms by which secondary prevention in~     patients with established heart disease may benefit from even lower LDL levels. By using~     PCSK9 inhibitors such as Alirocumab, very low LDL cholesterol levels not previously~     encountered in statin trials, can be achieved in patients with established heart disease on~     top of intensive statin treatment.~      This research is being carried out because it is unclear what the lowest threshold of LDL~     cholesterol should be to attain significant reductions in CV risk in stable cardiovascular~     patients. It is unknown whether there is a true limit of LDL cholesterol below which there is~     no further improvement in endothelial function in stable cardiovascular patients, and,~     whether this is associated with a reduction in markers of both systemic and vascular~     inflammation.~      Defining this may help identify individuals from the general population who may benefit from~     more aggressive lipid lowering treatment than standard statin treatment in terms of CV~     morbidity and mortality.~      This study will be conducted in patients with stable cardiovascular disease, where they will~     be randomized to receive either a combination of Alirocumab and statin, or Ezetimibe plus~     statin. 60 patients will be recruited to this single center, randomized, open label, parallel~     group, mechanistic physiological study which will be conducted at Cambridge University~     Hospitals NHS Foundation Trust. In order to be eligible for enrollment to the study, some~     patients may have to complete a 4 week washout period on a suitable statin therapy. The total~     study duration for each participant will be approximately 14 weeks, where a series of~     non-invasive vascular studies and medical imaging assessments which will be conducted to~     observe vascular/systemic inflammation and to assess endothelial vascular function.This study~     is funded by JP Moulton Charitable Foundation.~   "
16191|NCT03355014|"~     This study is to compare the safety/tolerability and pharmacokinetics/pharmacodynamics of the~     fixed-dose combinations of gemigliptin/metformin HCl sustained release 50/1000 mg (25/500 mg~     x 2 tablets) in comparison to each component gemigliptin 50 mg and metformin HCl extended~     release 1000 mg (500mg x 2 tablets) under fasting and fed conditions in healthy male~     volunteers.~   "
16192|NCT03355001|"~     The Monosyn® Quick non-interventional study (NIS) has been designed to implement an action~     within the framework of a proactive post-market surveillance system.~      The aim of this NIS is to collect systematically and proactively different clinical~     parameters regarding safety, effectiveness and performance of Monosyn® Quick suture material~     under the daily clinical practice when used as intended.~   "
16193|NCT03354988|"~     The primary aim of this study is to assess whether physical activity programs in preterm~     infants improve bone mineralization as well as growth and reduce the risk of fractures.~      The secondary aim is to include other potential benefits in terms of length of hospital stay,~     weaning from mechanical ventilation, feeding tolerance and adverse events~   "
16194|NCT03354975|"~     The primary goal of this study is to evaluate the feasibility and acceptability of employing~     an experiential training approach that targets community mental health therapists' attitudes~     toward and use of exposure therapy. In addition to assessing attitudes and use of exposure~     therapy, the study will evaluate the feasibility of recruitment, randomization, retention,~     and assessment processes, as well as the acceptability of the experiential training relative~     to training-as-usual. To assess these outcomes, community therapists will be randomized to~     experiential training or training-as-usual. A subset of therapists from each arm will also~     complete qualitative interviews to further assess acceptability of the training approaches.~     The training-as-usual condition will include a traditional one-day workshop that focuses on~     principles of exposure and incorporates active learning strategies. The experiential training~     will include a one-day workshop that teaches principles of exposure and has therapists~     themselves undergo a one-session phobia treatment for spiders. Therapists in both training~     conditions will be asked to attend weekly consultation phone calls for a three-month period~     following the trainings.~   "
16195|NCT03354962|"~     This study is a phase I/II, multicenter, open-label study starting with a phase I part~     followed by a Phase II part.~      The phase I part of the study aims at evaluating the safety and efficacy (in terms of~     abscopal effect at week 6) of the treatment combination schema of Stereotactic Body Radiation~     Therapy (SBRT) and PD-1 plus CTLA-4 inhibitors in patients with metastatic melanoma. Patients~     will be assigned in one of 3 cohorts depending the metastatic site. 18 patients will be~     enrolled in each cohort.~      Once the recommended optimal radiotherapy dose has been declared for the 3 cohorts, patients~     will be enrolled in the phase II part of the study in order to evaluate the activity~     (progression-free survival at 6 months) of SBRT given in combination with immune checkpoints~     inhibitors in patients with metastatic melanoma.~      71 patients will be included in the phase II.~   "
16196|NCT03354949|"~     The investigators looked at the population of hemiplegic stroke participants hospitalized~     with GHIV : the investigators assessed the postural control of the participants of the chair~     using MCPAA, and assessed the pain of the participants while sitting in a wheelchair. The~     investigators then had to the participants try positioning equipment and then prescribed it~     once the choice was made. The investigators then reassessed postural control and wheelchair~     pain with this positioning equipment.~   "
16391|NCT03352414|"~     The purpose of this study is to investigate the ability of alvimopan to reduce the time to~     return of bowel function in patients undergoing cytoreductive surgery and hyperthermic~     intraperitoneal chemotherapy. Half of the participants will receive alvimopan or and half~     will receive placebo immediately before and for up to seven days after surgery.~   "
16197|NCT03354936|"~     A Multicenter, Observational, National Cohort for HIV Infected Patients with a Cancer treated~     by Immune-Checkpoint Inhibitors (ICPi) for less than one month or to be treated with an ICPi~     such as anti-PD-1 or anti-PDL-1 or anti-CTLA4, monitored in some French hospitals .~      The objective of the study is to assess the safety of these new agents in HIV-infected~     patients.~      As an observatory, the number of participants planned is not predetermined: the aim is to~     include for 2 years any participant infected with HIV and having a cancer treated by ICPi in~     one of the centers that have agreed to participate.~      50 participants will be recruited for Substudy OncoVIRIM during the study period~     (regardless of tumor type or ICPi type); 8 or 9 time points (blood samples) will be scheduled~      The cohort  ANRS CO24 OncoVIHAC  is declared to authorities like category 2 research .~      No intervention in the observatory, a collection of data will be carried out in M0, M6, M12,~     M18 and M24.~      For the physiopathological Substudy OncoVIRIM : Blood samples will be collected to constitute~     cell bank, plasma bank, serum bank, DNA bank in order to meet the objectives of this substudy~     and possibly for complementary research~   "
16198|NCT03354923|"~     Early adolescence marks a significant development in teens' social abilities, shifting from~     play to conversation-based activities, and having stronger and more intimate friendships.~     Parents contribute to this shift by practicing reciprocal social interaction with their~     teens.~      For teens with Autism Spectrum Disorder (ASD) this shift in their peers' social abilities~     extends their characteristic social deficits even further. Social skills deficits in~     individuals with ASD are associated with poor adaptive functioning and increased~     psychopathology. Parents play a pivotal role in caring for and tutoring their children with~     ASD into adulthood. However, the effect parent-teen reciprocity has on the social skills of~     adolescents with ASD has not been tested. Furthermore, whereas parent-child reciprocity~     predicted intervention outcome in young children with ASD, no study has examined this effect~     in teens with ASD.~      The proposed study aims to test these questions using the Program for the Education and~     Enrichment of Relational Skills (PEERS), an evidence-based parent-assisted social skills~     training program for teens with ASD.~   "
16199|NCT03354910|"~     Live donor kidney transplantation (LDKT) offers the most optimal survival and quality of life~     benefit for those with late-stage chronic kidney disease. However, minorities, especially~     blacks, are much less likely to receive LDKT than whites. Given the shortage of deceased~     donor organs, interventions expanding access to LDKT are needed, particularly for minority~     patients. House Calls (HC), an educational intervention developed by this study's PI has been~     shown to be an effective program for raising rates of live donation, especially for black~     patients. While the HC program has shown outstanding results, participant feedback suggested~     that follow-up may provide even more benefits. Previous research suggests that peer~     mentorship (PM) from former or current patients with ESRD may be effective in raising rates~     of living donation. As such, peer mentorship programs may act as an effective follow-up for~     HC participants. This study will examine the impact of the HC intervention combined with the~     peer mentorship program of the National Kidney Foundation on rates of live donor kidney~     transplantation.~   "
16200|NCT03354897|"~     The hypothesis is based on UMOD rs13333226 genotype, there are two strata of hypertensive~     patients. The High-UMOD group (AA genotype) has increased UMOD excretion, greater salt~     sensitivity, HTN, normal eGFR and greater BP response to loop diuretics like furosemide. The~     Low-UMOD group (G allele) has decreased UMOD excretion, salt resistance, increased eGFR,~     increased proximal tubular reabsorption of Na (possibly related to increased GFR), a poor BP~     response to loop diuretics, and possibly diminished function of NKCC2. The High-UMOD strata~     will have decreased delivery of Na+ to the distal tubule and collecting duct because NKCC2~     function is normal and the study hypothesis is that the participants will be more responsive~     to loop diuretics. In contrast, the Low-UMOD group (G allele) will not show a similar~     response to loop diuretics. This may be related either to lower Na delivery to the TAL,~     because of increased proximal tubular reabsorption of Na+, or a suppressed function of NKCC2.~     The population distribution of the High-UMOD group (AA) is 67%. Our overall objective is to~     test the hypothesis that hypertensive subjects with uncontrolled HTN open possessing the AA~     genotype of rs13333226 will be better responders to loop diuretics compared to those~     possessing the G allele.~   "
16201|NCT03354884|"~     This is a single-arm, phase II trial (monocentric) study designed to determine To evaluate~     activity of Cabozantinib in terms of ORR according to the RECIST 1.1 criteria in Metastatic~     Collecting Duct Renal Cell Carcinoma~   "
16202|NCT03354871|"~     This study is set out to observe heart-rate and related bio-metric indicators in Obstetrics~     and Gynecology residents during their duty hours, together with self-reporting of fatigue and~     tasks performances, in order to model possible relationships between the two.~   "
16203|NCT03354858|"~     The purpose of this study is to investigate the impact of follicular flushing on the oocyte~     recovery rate, oocyte maturity, fertilization rate, and embryo development and utilization as~     compared to direct aspiration (no flushing) in women undergoing IVF treatment~   "
16204|NCT03354845|"~     Deprescribing is a systematic method of withdrawing potentially inappropriate or unnecessary~     medications and is warranted in the elderly due to the high prevalence of polypharmacy. In~     particular, symptomatic control medications, such as acid suppressants, laxatives and~     painkillers, are frequently prescribed and continued, though such medications are rarely~     needed on a long-term basis.~      Therefore, the study objectives were to determine the cost savings, effects and feasibility~     of implementing a systematic process of deprescribing medications for symptomatic management,~     namely, acid suppressants, laxatives, analgesics, and antiemetics.~   "
16205|NCT03354832|"~     Infant mortality is still relevant despite the improvement and the accessibility of hospital~     care. Premature birth are two fold higher than in metropolitan France. Some factors has been~     suspected such as precariousness, alcoholism, congenital malformation, care accessibility,~     epidemic environment ... Nevertheless, the impact of these factors on foetal death or~     new-born death are not yet sufficiently quantified to provide appropriate care and prevention~     action in Reunion Island.~   "
16438|NCT03351803|"~     The purpose of this study is to learn how to provide BRCA gene testing to a larger number of~     people as well as to make testing part of a person's regular medical care.~   "
22689|NCT03270007|"~     This is a phase IV, single-center, prospective, open-label, randomized,controlled study~   "
16206|NCT03354819|"~     Caring for people with dementia (PWD) poses many challenges which may cause high levels of~     caregiver stress. This study aims to investigate the effects of a modified Mindfulness-based~     Cognitive Therapy for stress reduction in the family caregivers of PWD. A prospective,~     single-blind, parallel-group randomized controlled trial (RCT) of 76 family caregivers of PWD~     will be recruited and randomized to either the MBCT or the control groups.The primary~     outcomes (stress) and secondary outcomes (anxiety, depression, burden, quality of life and~     resilience) will be measured at immediate post-intervention (T1) and at 3 months follow up~     (T2) which will be compared with the baseline (T0). Mixed repeated measure MANOVA will be~     performed to assess the effects of time, group, and time-group interaction on all outcome~     measurements.To understand the therapeutic components and identify the strengths,~     limitations, and difficulties of the MBCT program, process evaluation will be conducted~     through focus group interviews with 15 participants from the MBI group. It is hypothesized~     that the MBCT group will have a significantly greater reduction of stress (primary outcome)~     and improvement in the secondary outcomes, namely depression, anxiety, and burden, at T1~     and/or T2 than the control group.~   "
16207|NCT03354806|"~     Chronic obliterative arteriopathy of the inferior limbs is a frequent condition observed in~     diabetics. The later stages induce pain at rest and trophic disorders (ulcer, gangrene) that~     lead to chronic limb ischemia. Without possible surgical revascularization ,pain management~     and tissue healing are used to avoid amputation.~      Prevalence of diabetes is twice higher in Reunion Island than in metropolitan France. As a~     consequence, the rate co-morbobidities, such as chronic obliterative arteriopathy of the~     inferior limbs, is also increases.~      This study compares the efficiency of two analgesic treatments in diabetics with forefoot~     injuries.~   "
16208|NCT03354793|"~     The aim of this study is to compare the rate of obstetric complications at first spontaneous~     pregnancy among women with endometriosis, with the rate of obstetric complications at first~     spontaneous pregnancy among women without endometriosis~   "
16209|NCT03354780|"~     The aim of this study is to compare the rate of miscarriage at first spontaneous pregnancy~     among women with endometriosis with the rate of miscarriage at first spontaneous pregnancy~     among women without endometriosis.~   "
16210|NCT03354767|"~     Single-centre observational study over one year investigating the mechanisms of muscle~     homeostasis in patients with acute skeletal muscle atrophy following major aortic surgery~   "
16211|NCT03354754|"~     The purpose of the study is to evaluate whether LYS228 can be developed for the treatment of~     complicated intra-abdominal infections.~   "
16212|NCT03354741|"~     Poor control of chemotherapy-induced nausea and vomiting has a major clinical and~     psychological impact in patients treated with chemotherapy. Metabolic, nutritional and~     mechanical complications, as well as psychological repercussions, complicate the therapeutic~     management of the patient and can lead to poor compliance, a deterioration in the general~     condition or even prolongation of hospitalizations and a delay in the implementation of~     chemotherapy cures. The control of induced chemo- and radio-induced nausea and vomiting rests~     above all on their prevention. At present and in most centers, the prevention of nausea and~     vomiting in the pediatric onco-hematology department of the CHU de Nice is based exclusively~     on drug treatments, according to a protocol established according to the emetogenic risk of~     the chemotherapy received.~      We propose a study evaluating the effectiveness of the stimulation of acupuncture points by~     low frequency laser therapy associated with antiemetics in the management of chemotherapy~     induced nausea and vomiting in patients of 2 to 20 years followed in the service of~     analgesics. pediatric onco-hematology.~   "
16213|NCT03354728|"~     This phase I/II trial studies the side effects and best dose of multi-antigen cytomegalovirus~     (CMV)-modified vaccinia ankara vaccine and to see how well it works in treating pediatric~     patients with positive cytomegalovirus who are undergoing donor stem cell transplant.~     Multi-antigen CMV-modified vaccinia ankara vaccine may help people resist CMV~     life-threatening complications.~   "
16214|NCT03354715|"~     Comparing patient satisfaction and retention of upper complete denture fabricated using two~     different denture base materials, the first fabricated using rapid prototyping method while~     the second is following conventional methods.~   "
16215|NCT03354702|"~     Gambling Disorder (GD) is defined as the recurrent and persistent act of betting which leads~     to clinical impairments,. The latest edition of the Diagnostic and Statistical Manual of~     Mental Disorders (5th edition) conceptualizes GD as a behavioral addiction due to the~     similarities between GD and substance addictions in clinical presentation, association with~     personality factors, genetic transmission and treatment options. Previous studies found~     potential benefits of physical activity in treatment of addictions in general and GD in~     particular, such as reducing desire to play, betting and depressive and anxious symptoms.~   "
16216|NCT03354689|"~     Introduction: Cardiac sympathetic drive provides inotropic support to the failing heart and~     preserves cardiovascular homeostasis. Nonetheless, as myocardial insult evolves, this~     compensatory response leads to a progressive decline in contractile function, increases the~     vulnerability to arrhythmias and constitutes an independent mortality predictor. Despite~     advanced pharmacological therapies, side effects and persistent cardiac sympathetic overdrive~     highlights the modulation of the adrenergic system as a primary target for~     non-pharmacological strategies in the heart failure (HF) treatment. In this scenario, we will~     propose cervicothoracic transcutaneous electrical nerve stimulation (TENS) as a~     non-pharmacological therapy to attenuate cardiac sympathetic overdrive in patients with heart~     failure. Methods: In this prospective, randomized, sham-controlled, double-blind crossover~     trial, ten (10) HF patients under optimal pharmacological treatment will be randomly assigned~     to either an in-home cervicothoracic transcutaneous electrical nerve stimulation therapy~     (TENS: 30 min twice a day with 80 Hz frequency and pulse duration of 150 μs) or a sham~     control intervention (SHCI) for two weeks. Following a two-month washout phase from~     TENS/SHCI, patients crossed over and started the opposite condition. Washout rate and~     heart-to-mediastinum ratio (planar 123l-metaiodobenzylguanidine myocardial scintigraphy~     images), indexes of cardiac sympathetic activity and innervation density, muscle sympathetic~     nerve activity (microneurography) and brachial artery blood flow (Doppler ultrasound) during~     dynamic handgrip exercise will be obtained at the beginning and end of each condition.~   "
16218|NCT03354663|"~     This clinical investigation is intended to demonstrate the acute safety and effectiveness of~     ablation with the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE)~     for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation~     (PAF). This clinical investigation will be conducted under an investigational device~     exemption (IDE) and is intended to support market approval of the TactiCath SE ablation~     catheter in the United States. One hundred fifty six (156) subjects will be enrolled at up to~     35 investigational sites in the US, Europe, and Australia. This clinical investigation is~     sponsored by Abbott.~   "
16219|NCT03354650|"~     Neonatal sepsis is an important cause of morbidity and mortality in the pediatric age group .~     It is one of the leading causes of death in the first 28 days of life both in the developed~     and developing countries.~   "
16220|NCT03354637|"~     Primary:~      • To assess safety, tolerability and efficacy of 2 dose strengths of ATI-50002 Topical~     Solution, compared to vehicle in subjects with alopecia areata (AA)~      Secondary:~      • To evaluate key clinical outcome assessments~   "
16221|NCT03354624|"~     The purpose of this study is to investigate the sensory-motor cortical excitability response~     to delayed onset muscle soreness (DOMS) on Extensor Carpi Radialis (ECR) muscle during muscle~     hyperalgesia provoked by nerve growth factor (NGF).~   "
16222|NCT03354611|"~     Up to one hundred (100) female patients will be enrolled and consented to participate in the~     study. These women will be enrolled from screening assigned BIRADS 0, patient complaint, or~     referral for second opinion. The enrolled patient will accept CE-CBBCT scans within 4 weeks~     of her diagnostic mammography and before breast biopsy if biopsy is needed. The final~     diagnostic workup outcome of these enrolled patients needs to include at least 30 confirmed~     cancers cases.~   "
16223|NCT03354598|"~     This is a prospective, Phase 3, randomized, multi-center, double-blind study of the efficacy,~     tolerability, and safety of PF-03709270 (sulopenem etzadroxil) with probenecid versus oral~     ciprofloxacin for treatment of uncomplicated urinary tract infection in adult women~   "
16224|NCT03354585|"~     The aim of this study is to determine the neural mechanisms supporting the modulation of~     chronic low back pain by meditation. The primary hypothesis is that mindfulness will be~     associated with greater activation of the orbitofrontal and anterior cingulate cortices, as~     well as regions involved in the regulation of emotion.~   "
16225|NCT03354572|"~     Despite current available analgesic drugs, post-surgical pain management remains challenging.~     A potential new target for analgesic drugs are group-II metabotropic glutamate receptors~     subtypes (mGlu2 and mGlu3 receptors), since growing evidence from animal models show that~     activation of these receptors produce s analgesic effects in inflammatory and in neuropathic~     pain states. . N-Acetylcysteine (NAC) is a safe agent and with little to no side effects. NAC~     can induce analgesia by activating the glutamate:cystein antiporter, causing endogenous~     activation of the mGlu 2/3 receptors. However, this has only been investigated once in the~     peri-operative setting, were it showed preliminary promising result of reduction in opiate~     necessity. In healthy subjects there was a significant reduction in pain ratings to laser~     stimuli and amplitudes of laser evoked potentials after NAC. Based on these promising~     results, we hypothesize that pre emptive intravenous NAC can reduce postoperative pain and~     thereby cause less necessity for escape analgesics like opiates.~   "
16226|NCT03354559|"~     In severe trauma patients, uncontrolled bleeding is a major cause of death, partly caused by~     trauma-induced coagulopathy (TIC).TIC represents a severe post-traumatic complication~     associated with increased transfusion requirements and worsened mortality. Fibrinolysis is a~     central part of the TIC process. Massive Transfusion Protocols (MTPs) were introduced as part~     of damage control resuscitation, with the aim to facilitate rapid blood product release and~     to increase adherence to hemostatic resuscitation, In 2013, the Italian Trauma Centers~     Network (TUN) developed a new treatment algorithm providing early coagulation support (ECS)~     to control coagulopathy and hemorrhage in major trauma patients with a clinically relevant~     bleeding risk. The protocol includes the use of fibrinogen concentrate and RBC during initial~     resuscitation, and the early use of viscoelastic techniques when available~     (thromboelastometry ROTEM® or thromboelastography TEG).~      The aim of this multicenter, before and after study was to assess the effects of a new ECS~     protocol compared to the standard MTP in terms of blood products' consumption and clinical~     outcome.~   "
16227|NCT03354546|"~     The investigators will create a frailty index using health administrative data available for~     older people having surgery. The index will be based on the Canadian Study of Health and~     Aging Frailty Index and standard recommendations for creation of frailty indices.~   "
16228|NCT03354533|"~     Study of ORL-1F in Patients With Leukocyte Adhesion Deficiency Type II~   "
16229|NCT03354520|"~     The study is to maximize efficacy of message delivery to achieve desired Obstructive sleep~     apnea (OSA) adherence goal. Newly diagnosed black patients (n=390, all genders) from~     participating sleep clinics will be randomly exposed to either the individually tailored or~     standard OSA messages. Investigators will look at an effective and scalable intervention to~     improve OSA-related outcomes: a) clinical CVD and brain health measures and b)~     patient-centered outcomes. Patient-centered and adherence data will be captured via REDCap,~     enabling real-time application of data-driven decision rules while implementing the~     intervention.~   "
16230|NCT03354507|"~     Effect of oral sodium bicarbonate therapy on renal tubular acidosis in epilepsy patients~     taking topiramate.~   "
16237|NCT03354416|"~     Background:~      Prostate cancer is one of the most common cancers for men in the U.S. There are some new ways~     to take pictures of the cancer. There are also new ways to use image-guided biopsy and~     therapy. These could help manage prostate cancer. Researchers want to study how imaging can~     provide a profile of prostate cancer. They want to collect data to make diagnosis and~     treatments better.~      Objectives:~      To gather data about the radiological and clinical course of prostate cancer. To study~     imaging-based biomarkers of prostate cancer.~      Eligibility:~      Men ages 18 and older with diagnosed or suspected prostate cancer~      Design:~      Participants will give permission for researchers to use their medical history and records.~     Their data will be reviewed, collected, and analyzed. These include results of their tests~     and scans.~      Sponsoring Institution: National Cancer Institute~   "
22690|NCT03269994|"~     The purpose of this study is to figure out which commonly used antibiotic, cefoxitin or~     piperacillin-tazobactam, is better at decreasing the rate of surgical site infections after~     pancreatoduodenectomy.~   "
16231|NCT03354494|"~     Currently, controlled ovarian stimulation (COS) in oocyte donors is performed by daily~     injections of gonadotropins( recombinant FSH) plus a GnRH Antagonist usually form 5th-6th~     stimulation day until ovulation induction with a bolus of another injection of a~     gonadotropin-releasing hormone (GnRH) Agonist. Injections of the GnRH Antagonist avoid~     untimely luteinizing hormone (LH) surge and spontaneous ovulation prior to follicular~     aspiration. There is a preparation of long-acting recombinant follicle stimulating hormone~     (rFSH= (corifollitropin alfa (FSH-CTP), Elonva®, MSD), that allows that a single subcutaneous~     injection substitutes the first 7 days of daily gonadotropin injections. On the other hand, a~     contraceptive oral progesterone only( Desogestrel, DSG) is available for contraception,~     avoiding the LH surge.~      In donors, by administering a single injection of FSH-CTP and oral desogestrel since the~     first menstruation day, the total number of injections administered is reduced and less~     discomfort is experienced without adverse impact on ovarian response.~      Other authors have reported good results using similar synthetic progestins~     (Medroxyprogesterone, dihydrogesterone, and natural progesterone).~      No description of the hormonal and ovarian response under this protocol has been published.~     Direct comparison between this novel protocol and the classical GnRH- antagonist plus daily~     gonadotropins has not been reported.~   "
16232|NCT03354481|"~     Researchers in numerical cognition usually think that the greatest and most common difficulty~     in children suffering from dyscalculia is retrieval of arithmetic facts from long-term~     memory. However, we have recently shown that retrieval might not be the optimum strategy in~     mental arithmetic. In fact, expert adults would rather solve simple problems such as 3 + 2 by~     automated and unconscious procedures. Therefore, we hypothesize that children with~     dyscalculia might not present deficit in retrieval but, instead, in counting procedure~     automatization. The aim of the current project is to test this challenging position. Through~     a longitudinal approach, we plan to precisely examine the behavior of children suffering from~     dyscalculia over a 3-year period. Children will be aged between 8 to 11 years at the~     beginning of the study and we will precisely observe the evolution of their solution times~     when they solve simple addition problems involving one-digit numbers. If children with~     dyscalculia still struggle with simple additions three years, their solution times plotted on~     the sum of the problems should still follow an exponential function. Indeed, if counting is~     not automated, difficulties necessarily increase with the progression on the number line or~     the verbal sequence, hence the exponential function. On the contrary, if counting procedures~     tend towards automatization, moves along a number line will progressively become as easy at~     the beginning of the line as at the end, hence the linear function. Importantly, a retrieval~     model would predict exactly the inverse pattern because, according to this model, the linear~     function, which is unanimously considered as the hallmark of counting procedures, should~     progressively be replaced by a non-linear function through practice.~   "
16233|NCT03354468|"~     The incidence of fractures in Norway is among the highest in the world, and falls are the~     sixth major contributor to years lived with disability. In elderly, a large part of 900~     deaths from unintentional injuries per 100000 inhabitants per year, are due to falls and~     fractures. Fractures, especially hip fractures among the elderly, often result in pain,~     ailments, and reduced quality of life. In Norway, 11 % of all reports from the specialized~     health services were incidents related to falls. Worldwide, falls are among the most commonly~     reported adverse events in hospitals with prevalence rates in the order of 10 per 1000~     patient days or 5-15 % of the patients, and are associated with both minor and major~     injuries. The results of preventive measures are conflicting.~      In January 2011, the Norwegian health minister launched a national patient safety campaign~     called In Safe hands. The campaign had three aims: 1) Reduce patient related adverse~     events, 2) Build sustainable systems and structures for patient safety, and 3) Improve the~     patient safety culture. Hospitals and primary care units were invited to participate in 16~     specific and measurable areas for improvement. One out of four orthopedic departments at Møre~     og Romsdal Hospital Trust, Norway participated actively in a fall prevention program.~      This study compares the changes in fall rates, the employees' perceived patient safety~     culture and the patient experienced safety before and after implementation of the fall~     prevention program at the orthopedic department in one hospital in the Møre & Romsdal~     Hospital Trust, and at the same time points i another hospital in the same Trust but not~     having implemented the program.~   "
16234|NCT03354455|"~     Using a within‐subject cross‐over design, we will include 20 patients with Parkinson disease~     (PD) and peak‐of‐dose dyskinesia.~      Patients will be studied after withdrawal from their normal dopaminergic medication.~      On two separate days, each patient will receive off‐line, effective (high‐intensity) or~     ineffective (low‐intensity) 1 Hz repetitive transcranial magnetic stimulation (rTMS) of the~     presupplementary motor area (preSMA) before functional magnetic resonance (fMRI). Immediately~     after the patient will perform a Go/No-Go task during fMRI in the the OFF state for 9~     minutes. Then the scan is paused and the patient will receive 200 mg fast‐acting oral~     levodopa and undergo whole‐brain task‐related fMRI at 3 Tesla until peak‐of‐dose dyskinesia~     will emerge.~      During task‐related fMRI, patients has to click on a mouse with their right hand (Right‐Go),~     left hand (Left‐Go), or no action (No‐Go) in response to arbitrary visual cues.~      The patients will also be tested for different aspects of impulsivity using~     neuropsychological questionnaires and computerized tests.~   "
16235|NCT03354442|"~     This experimental study aims to evaluate the efficiency of the Modified Fixed Mandibular~     Retractor Appliance in the treatment of skeletal class III malocclusion.~      The study sample will consist of 44 patients with skeletal class III malocclusion. The sample~     will be allocated randomly into two groups: experimental group and untreated control group.~      The soft and hard tissue changes will be assessed using lateral cephalometric radiographs~     before the treatment and after obtaining 3mm positive overjet.~   "
16236|NCT03354429|"~     Study to investigate if the study drug ticagrelor and ASA is more effective than Placebo~     (inactive tablet) and ASA in preventing new stroke events~   "
16244|NCT03354325|"~     This study evaluates the value of routine follow-up with a child's pediatrician after~     hospitalization for bronchiolitis. Parents of half of participants will be instructed to~     follow-up with the child's pediatrician regardless of symptom resolution, while the other~     half will be instructed to follow-up on an as-needed basis (only if the child worsens,~     doesn't improve, or other concerns develop).~   "
22706|NCT03269786|"~     laboratory and ultrasongraphicc changes after endoscopical varices treatment~   "
16238|NCT03354403|"~     Background:~      X-linked retinoschisis (XLRS) is a genetic condition. It usually presents in boys in~     childhood with vision loss. Genetic conditions affect the people who have it and also their~     family members. Researchers want to learn if mothers and fathers react differently when a son~     gets XLRS. They also want to learn how personality impacts the way people react. This will~     help researchers find better ways to support families living with XLRS.~      Objective:~      To learn more about the experiences of mothers of sons with XLRS compared to fathers of sons~     with XLRS. Also to study personality differences between mothers and fathers.~      Eligibility:~      Parents of a biological son of any age with XLRS who is enrolled in protocol 03-EI-0033~      Design:~      Participants will be asked questions in person or by phone. This will last 30 90 minutes.~     They will be asked about their experience with XLRS and how it has impacted their family. The~     interview will be recorded.~      Participants will complete a survey about personality traits. It will be anonymous. It can be~     completed by mail, email, or fax. It will take about 15 minutes.~      Participants data may be shared with others, including those not at NIH, if they agree. Their~     data may be stored.~      Sponsoring Institution: National Eye Institute~   "
16239|NCT03354390|"~     Background:~      Gene transfer is a new cancer therapy takes white blood cells from a person and grows them in~     a lab. The cells are changed with a virus to attack tumor cells, then returned to the person.~     Researchers want to see if this therapy fights kidney cancer cells.~      Objective:~      To see if gene transfer is safe and causes tumors to shrink.~      Eligibility:~      People at least 18 years old with certain kidney cancer~      Design:~      Participants will be screened with blood and urine tests. They may have:~        -  Scans~        -  Heart, lung, and eye tests~        -  Lab tests~        -  Tumor samples taken~      Participants will have leukapheresis. Blood will be removed by a needle in an arm. It will go~     through a machine that removes white blood cells. Plasma and red cells will be returned~     through a needle in the participant s other arm.~      Participants cells will be grown in the lab and genetically changed.~      Participants will stay in the hospital 2 3 weeks. There they will:~        -  Get 2 chemotherapy drugs by catheter (thin plastic tube) inserted into a vein in the~          chest.~        -  Get the changed cells via catheter.~        -  Get a drug to increase white blood cell count and one to make the cells active.~        -  Recover for about a week.~        -  Have lab and blood tests.~      After leaving the hospital, participants will:~        -  Take an antibiotic for several months.~        -  Have leukapheresis.~        -  Have one- or two-day clinic visits every few weeks for 2 years, and then as determined~          by their doctor. These will include blood and lab tests, imaging studies, and physical~          exam.~      Participants will have follow-up checks for up to 15 years.~      Sponsoring Institute: National Heart, Lung, and Blood Institute~   "
16240|NCT03354377|"~     This study addresses two challenges seen among African American (AA) participants during~     previous weight loss and dietary interventions aimed at reducing cardiovascular disease (CVD)~     risk: poor weight loss results and high attrition rates. Investigators will target both of~     these challenges by using a randomized design to compare a plant-based dietary intervention~     (vegan diet) vs. an omnivorous (omni) diet and by focusing on culturally-tailored food~     choices for AA adults living in the South. Therefore, the objective of the study is to~     conduct a culturally-tailored, randomized trial examining how a vegan diet affects CVD risk~     factors and weight as compared with an omni diet. The study will randomize overweight AA~     adults (n=130) to follow one of two different diets (vegan or omni) for 24 months.~     Investigators will accomplish objectives and test hypotheses by following two specific~     primary aims:~      Primary Aims: Using a randomized design, determine the impact at 12 months of two different,~     culturally tailored diets (n=65 omni and n=65 vegan) on changes in:~        1. Risk factors for CVD, including LDL cholesterol and blood pressure; and~        2. Body weight.~           Secondary Aim~        3. Examine long-term changes in CVD risk factors and body weight at 24 months.~   "
16241|NCT03354364|"~     The purpose of this study is to determine the effects of daily consumption of snacks with and~     without pea hull fiber on gastrointestinal function, gastrointestinal symptoms, food intake,~     appetite, changes in fecal and microbial composition and activity. Fifty maintenance~     hemodialysis hemodialysis and CKD patients in stage 4 or 5 will be recruited to participate~     in a randomized, blinded, 13-week cross-over study evaluating snack foods containing 15 g/d~     of pea hull fiber.~   "
16242|NCT03354351|"~     Mood disorders, anxiety disorders, and trauma-related stress (MD\AD\TRS) are common among~     men, particularly those suffering from heart disease (HD). MD\AD\TRS are significantly~     related to exacerbation of HD symptoms that often lead to death. Unfortunately, men are~     significantly less likely than women to seek and receive appropriate treatment for their~     mental health issues including MD\AD\TRS. Furthermore, there is little literature about the~     use of the stepped care model in the Canadian setting.~      The overarching goal of this interventional program is therefore to prevent, early detect and~     treat MD\AD\TRS in men living with HD. This Participatory Action Research aims to implement a~     stepped-care model for MD\AD\TRS in men in New Brunswick, Ontario, and quebec. The second~     phase of the project proposes a quantitative study that will consist of testing the~     effectiveness and acceptability (by the men and the involved health professionals) of the~     stepped-care model. It will offer to post ACS-males a mental health related component~     presently not available in the typical services of the NB health system.~      Data will be collected at baseline (0 month) and at four follow-up (each 3-months) sessions~     to manage the progress of each participant throughout their 12-month journey in the study.~     Typical sociodemographic data will be collected, along with a questionnaire on Masculinity~     Norms, Couples Satisfaction (when applicable), and four mental health assessment tools.~   "
16243|NCT03354338|"~     There are not published studies evaluating the incidence, nature, magnitude and/or duration~     of bacteremia after periodontal treatment. The pre-surgical antibiotics have been studied~     particullary over Gram positive bacterial but not over gram negative bacterial and their~     secondary effects over the systemic pro-inflamation. Objective: to evaluate the efficacy of~     intensive periodontal therapy and pre-medication with oral amoxicilline on inflammatory~     bio-markers and the incidence, duration and magnitude of bacteremia in patients with chronic~     periodontitis.~   "
16267|NCT03354026|"~     The purpose of this research is to use the Removing Blood Stasis Decotion of traditional~     Chinese medicine treating the acute stage of cerebral hemorrhage with stroke associated~     pneumonia to explore the impact of Removing Blood Stasis Therapy on intestinal microbial~     flora either within the time window from 6 to 72 hours onset.~   "
16245|NCT03354312|"~     This project is a national, open label, multicenter, randomized split-mouth study in patients~     from 18 to 70 years of age to compare the efficacy and acceptability of lidocaine gel~     compared to injection anesthesia with articaine (infiltration anesthesia for the upper jaw~     and infiltration or nerve block anesthesia for the lower jaw). It is planned that about 90~     patients with a proven moderate periodontitis will be enrolled in 5 German study centers.~      Dynexan Mundgel® (lidocaine hydrochloride) is a topical anesthetic gel containing lidocaine~     that is commercially available as an anesthetic for temporary, symptomatic treatment of pain~     at the oral mucosa, gingiva and lips. The gold standard for scaling and root planing (SRP) is~     still the use of injection anesthesia. This raises the question what kind of anesthesia~     patients would prefer if they had a free choice.~      For this study Ultracaine® D-S 1:200,000 (articaine hydrochloride/epinephrine hydrochloride)~     was selected as the injectable comparator drug because it is the most frequently used~     anesthetic drug for infiltration and nerve-block anesthesia in Germany at present.~   "
16246|NCT03354299|"~     Liver cirrhosis still becomes a major issue in Indonesia. Malnutrition has been observed in~     liver cirrhosis patients as it deteriorates liver function and cirrhosis itself. Malnutrition~     in liver cirrhosis can increase morbidity and mortality rates.~      Patients with liver cirrhosis have increased energy expenditure and endogenous fat oxidation~     reaction which is used as the basic energy sources. Energy obtained from fat was accounted~     for 86% of the total energy sources in this population. Fatty acid is also known to be an~     efficient energy backup for hepatocytes and other cells because it generates higher adenosine~     triphosphate (ATP) than other sources.~      Supplementary diet for patients with liver cirrhosis is considered beneficial for preventing~     hypercatabolism. To fulfill their nutritional needs, patients with liver cirrhosis is advised~     to take an extra food, such as a late night snack (LNS) with a total carbohydrate of around~     50 g (equivalent to 200 kkal). Considering that most of the energy source in patients with~     liver cirrhosis came from fat, so the additional sources of energy having a high fat content~     were considered to be potentially highly beneficial to address the patients' nutritional~     status, as well as to reduce the risk of hyperglycemia after a meal and hypoglycemia after a~     long night fasting period time.~      Coconut milk contains many saturated fatty acids belonging to the medium chain~     triacylglycerol (MCT) group. The characteristics of MCT are quite different from long chain~     triacylglycerol (LCT). MCTs are more easily absorbed than LCTs, and are mostly absorbed in~     the form of free fatty acids, in both healthy and liver cirrhosis populations.~      This study wants to investigate the effects of coconut milk supplementation on improving the~     nutritional status of patients with liver cirrhosis. The patients were divided into 2 groups,~     groups I received 25 g of sugar plus 50 cc of coconut milk (200 kkal) as late night snacks~     (LNS); and group II received 50 g of sugar alone (200 kkal) as LNS. Investigators think that~     the group who received coconut milk supplementation has better nutritional status than the~     other group.~   "
16247|NCT03354286|"~     This study will examine the impact of a closed-loop insulin delivery system intervention on~     health and psychological outcomes in families with young children with Type 1 Diabetes (T1D).~   "
16248|NCT03354273|"~     This is a Phase 3, prospective, open-label, international, multicentre study of Flurpiridaz~     (18F) Injection for PET MPI in patients referred for ICA because of suspected CAD.~   "
16249|NCT03354260|"~     The purpose of the present study is to evaluate the effects of a personalized oral diet in~     the critically ill patients during ICU stay and after as compared usual oral diet.~   "
16250|NCT03354247|"~     Non-Alcoholic Fatty Liver Disease (NAFLD), including its more pathologic consequence,~     non-alcoholic steatohepatitis (NASH), is believed to be the most common chronic liver disease~     worldwide, affecting between 6 to 37% of the population. NAFLD is a so called 'silent~     killer', as clinical symptoms only surface at late stages of the disease, when it is no~     longer treatable: untreated, NAFLD/NASH can lead to cirrhosis and hepatocellular carcinoma,~     culminating in liver failure. Several factors may contribute to the pathogenesis of NAFLD,~     including genetic assessment and mitochondrial dysfunction. Patients with NAFLD/NASH display~     disturbances of intestinal permeability, and gut microbiota. In the most of cases, NAFLD/NASH~     is strongly linked to other metabolic conditions, including visceral adiposity. Currently the~     best method of diagnosing and staging the disease is liver biopsy, a costly, invasive and~     somewhat risky procedure, not to mention unfit for routine assessment. Weight loss is the~     first step approach with reasonable evidence suggesting it is beneficial and safe in~     NAFLD/NASH patients. However, the efficacy of weight reduction for the treatment of~     NAFLD/NASH has not been carefully evaluated. Several studies on the effects of weight~     reduction on NAFLD/NASH have been uncontrolled, used poorly defined patient populations and~     non-standardized weight loss interventions, and lacked a well-accepted primary outcome for~     NASH.~      The objective of the project is to conduct a randomized controlled trial of 1 year-long~     weight reduction in the management of NAFLD/NASH patients using a lifestyle-dietary~     intervention program. Overweight or obese individuals with biopsy or ultrasonography (US)~     -proven NAFLD/NASH will be randomized to receive either standard medical care and educational~     sessions related to NAFLD/NASH, healthy eating, weight loss, and exercise (control group); or~     to an intensive weight management with a goal of at least 7-10 % weight reduction (lifestyle~     intervention group). The weight loss intervention will be modelled on~     Mediterranean-intervention-diet. The investigators hypothesize that a 7-10% weight reduction~     through intensive lifestyle intervention will lead to improvement of clinical, US,~     anthropometric, and biochemical features on patients diagnosed with NAFLD/NASH.~   "
16251|NCT03354234|"~     The pilot study aims to evaluate a prototype system that enables military pilots to train~     under conditions of orthostatic hypotension and ischemic hypoxia. Both of these phenomena are~     experienced by aircraft crews of mainly highly maneuverable aircraft, and their syndromes~     include loss of color vision, loss of peripheral vision, blackout and finally G-induced loss~     of consciousness (G-LOC). A motorized tilt table to generate orthostatic (ORTHO) stress~     combined with an automatically controlled lower body negative pressure (LBNP) chamber to~     extort pooling of blood in the lower extremities has been developed in order to obtain new~     knowledge on counteracting the above-mentioned effects and minimizing the risk of their~     occurrence. This will help optimize the selection procedures of candidates with the best~     physiological predispositions to work as military pilots. The system is equipped with modules~     for monitoring biomedical parameters of a subject, including cerebral oxygenation, which~     ensures their safety and provides a source of data for performing advanced analyses. The~     ORTHO-LBNP system has been subjected to comprehensive laboratory tests and after a successful~     testing is ready for a pilot study involving pilots and/or cadets of the Polish Air Force~     Academy (PAFA). It is anticipated that new indicators will be proposed to enable an objective~     assessment of the predispositions to pursue a military pilot career. The prototype system can~     be easily adaptable to the needs of clinical and sports medicine as well as rehabilitation.~   "
16252|NCT03354221|"~     This research is being done to see if the investigators can use the cytosponge or esophacap~     (depending on availability) to determine if shorter duration SFED (two weeks versus six~     weeks) would have equal results.~   "
16253|NCT03354208|"~     Verification of biomarkers in a human population for their ability to diagnose the severity~     of neonatal asphyxia. These biomarkers linked to asphyxia have been identified in animal~     studies.~   "
16268|NCT03354013|"~     This is an interventional comparative study at the Department of Reproductive Medicine at~     Ghent University Hospital. Patients with previous embryo developmental problems are eligible~     for the study. Patients will undergo an ICSI-AOA treatment and will also be screened for~     genes important in the oocyte activation and embryonic development process. Also, the calcium~     releasing pattern of the patients' spermatozoa will be investigated.~   "
16254|NCT03354195|"~     This study represents a single-surgeon/institution, non-randomized, consecutive series,~     prospective and comparative cohort design. The Principal Investigator is anticipating 100~     study patients in the INTACT group and 35 patients in the Anterior Cruciate~     Ligament-Deficient group.The schedule of events lists the imaging procedures and~     questionnaires to be completed at each visit.~      Subjects will be consented and enrolled within 28 days prior to surgery and participate in~     follow-up visits for two years following their Unicompartmental Knee Arthroplasty. A 3-year~     enrollment duration is anticipated to enroll a minimum and consecutive series of 25 patients~     in the experimental Anterior Cruciate Ligament-deficient group. Over the same enrollment~     duration, 100+ patients with intact Anterior Cruciate Ligaments are expected to be in the~     control group and undergo Unicompartmental Knee Arthroplasty. The enrollment duration (3~     years) and total study duration (5 years) are based on patient volume estimates provided by~     the Principal Investigator.~   "
16255|NCT03354182|"~     The aim of the study was to perform a randomized controlled clinical study in order to~     compare the effects of a bovine derived xenograft (with 10% collagen) + a bioabsorbable~     membrane (control group, CG) vs a bovine derived xenograft (with 10% collagen) alone (test~     group, TG) on the surgical treatment of mandibular type II furcation defects.~   "
16256|NCT03354169|"~     The randomized, cross-over design study is designed to determine how timing of eating affects~     weight, adiposity, energy metabolism, and gene expression. Obese participants will be~     provided isocaloric meals and snacks to be consumed in one of two prescribed eating~     conditions -- daytime eating and delayed eating.~   "
16257|NCT03354156|"~     The innate immune system plays a pivotal role in the development and progression of~     atherosclerosis. Recently, it was reported that monocytes can develop a long-lasting~     immunological memory after stimulation with various microorganisms, which has been termed~     'trained innate immunity'. This memory is induced by epigenetic reprogramming, in particular~     trimethylation of lysine 4 at histone 3 (H3K4me3).~      In this study, the investigators aim to investigate the immunophenotype of circulating~     monocytes in patients with elevated LDL cholesterol levels and the effect of statins on this~     phenotype.~   "
16258|NCT03354143|"~     The aim of this study is to determine if lowering blood pressure using FDA approved~     medication (antihypertensive drugs) alters brain pulsatility and reduces brain amyloid beta~     protein accumulation in older adults. Amyloid beta protein is high in the brain of older~     adults with Alzheimer's disease. Hypertension may increase brain amyloid beta protein~     accumulation and affect memory and thinking ability in older adults. However, whether~     lowering blood pressure reduces brain amyloid beta protein and improves brain function is~     inconclusive.~      The investigators hypothesize that treating high blood pressure alters brain pulsatility,~     which in turn reduces brain amyloid beta protein accumulation and improves brain structure~     and function.~   "
16259|NCT03354130|"~     The intake of processed meat products has been linked to several adverse health outcomes.~     However, estimation of their intake proves difficult. This study aims at identifying~     biomarkers of intake for processed meat products in blood and urine. For this, participants~     of a randomized cross-over dietary intervention will consume highly controlled diets~     containing non-processed pork, different processed meat products or no meat. Urine and plasma~     will be collected and analysed to identify sets of metabolites that are specific for the~     intake of the processed meat products.~   "
16260|NCT03354117|"~     This is an exploratory prospective study investigating if addition of a COX-2 inhibitor can~     increase efficacy of ulipristal in disrupting ovulation at peak fertility.~   "
16261|NCT03354104|"~     Microsurgical tunneling flap procedures using connective tissue grafts (CTG) are predictable~     for treating teeth with gingival recessions. Enamel matrix derivatives (EMD) can be used as~     an alternative to the aforementioned gold standard. The aim of this study is to evaluate~     clinically the use of tunnel technique with EMD applied group in addition to CTG and the same~     technique with CTG group for the treatment of multiple gingival recessions.~   "
16262|NCT03354091|"~     The aim of this project is to explore if monitoring physical activity including feedback can~     have any effect on physical activity level, function, work ability, health related quality of~     life or work productivity among individuals with hip and/or knee osteoarthritis. This will be~     performed by evaluating the use of mobile technology and activity monitoring to support~     physical activity in individuals with OA in a cluster randomized controlled trial. The~     investigators research questions are:~      • Can an intervention, comprised of the above mentioned technology, have any effect on~     physical activity level, function, work ability, quality of life or work productivity among~     individuals with OA?~   "
16263|NCT03354078|"~     Only a small number of research studies evaluated the impact of various subcutaneous tissue~     and skin closure methods at cesarean section. In a meta-analysis a major decline in incision~     site rupture was revealed when suturing the subcutaneous tissue in women with a subcutaneous~     depth >2 cm.~   "
16264|NCT03354065|"~     Objective: Determine tolerance of immediate oral intake (8 hours posterior to the beginning~     of treatment) against traditional management (early feeding at 48hr) in patients with mild~     acute pancreatitis of biliary origin.~      Double blind, randomized clinical trial~   "
16265|NCT03354052|"~     Pain is a common symptom experienced by people following stroke and can significantly~     interfere with participation in the activities of daily living and adversely affect~     health-related quality of life. Repetitive Transcranial Magnetic Stimulation (rTMS) promotes~     the modulation of brain activity and its prolonged and continuous application can effect~     plastic modification. Combining rTMS with rehabilitation treatment for primary motor cortex~     activation (using Gloreha® device) may have effect in reducing pain in stroke survivors. This~     is a pilot randomized control trial to test the effects of rTMS in stroke-related pain~     rehabilitation, its efficacy on pain, upper limb function, sensory function and autonomy in~     daily livings activities. Furthermore, we will explore the effects on pressure pain~     threshold, cortical excitability and EEG recording.~   "
16266|NCT03354039|"~     A randomised, double blind, placebo controlled, 48-week clinical trial with a core population~     (group A) of 79 ambulant 6.5 to 12 years old Duchenne's muscular dystrophy (DMD) patients~     that are under stable standard treatment of care with glucocorticoids. Furthermore, the~     investigators plan to include 16-20 non-ambulant patients who do not receive glucocorticoids~     (as parallel group B), 10 to 16 years old, to obtain efficacy and safety data in a broader~     DMD population. All patients will receive 20 mg of tamoxifen (TAM) or placebo once daily~     during 48 weeks.~   "
16270|NCT03353987|"~     Postoperative Cognitive Dysfunction (POCD) is a state of decline in cognitive ability after~     surgery and is frequently seen among our elderly population. Many studies have looked into~     predictive risk factors for POCD while research is underway to search for pre-emptive~     measures to avoid this unfavourable outcome. Most will be looking at utilizing mobile~     software applications of cognitive training but in many poorer countries, owning electronic~     devices may not be an option or may be culturally less acceptable among the older patients.~     Hence, the investigators intend to investigate if a home-based logbook for cognitive training~     will reduce the incidence of POCD in a single centre study.~   "
16271|NCT03353974|"~     Multiple Sclerosis (MS) is often characterized by the presence of balance and cognitive~     impairments. Cognitive functions play a key role in balance control. Simultaneously~     performing cognitive tasks decreases walking and balance ability (Dual-Task cost).~     Rehabilitative treatment of patients with MS does not have to consider separately the motor~     and cognitive aspects. Video-Game Therapy (VGT) is a novel tool that allows a multimodal~     training approach. VGT typically provides augmented feedback during training that can~     contribute to learning motor skills. The main objective of this exploratory study will be to~     test the effects of a commercially available VGT on balance and cognitive function in~     ambulatory MS patients compared to a standardized balance platform training (BPT). Secondary,~     we will explore the effects of VGT and BPT on other domains that are usually impaired in MS~     population and that can be improved by motor rehabilitation, such as psychological~     well-being, fatigue and Quality of Life. Another specific aim will be to better explore the~     neuronal correlate during video game therapy using the Functional Near-infrared Spectroscopy~     (fNIRS). Finally, patient motivation and satisfaction during VGT and BPT will be monitored~     with a specific questionnaire.~   "
16272|NCT03353961|"~     To evaluate if Internet delivered emotion regulation individual therapy for adolescents is an~     efficacious treatment when delivered as adjunctive to treatment as usual compared to a~     control group consisting of treatment as usual.~   "
16273|NCT03353948|"~     The aim of this study was to evaluate the impact of low dose liraglutide in combination with~     metformin compared to metformin alone on IVF pregnancy rate (PR) and cumulatively PR (IVF and~     spontaneous) in infertile obese women with PCOS who had been previously poor responders~     regarding weight reduction with lifestyle modification and resistant to first line~     reproductive treatments.~   "
16274|NCT03353935|"~     Patients who underwent surgery for deep endometriosis were submitted to procedures aiming at~     sparing the pelvic autonomic nervous system. They were observed prospectively followed and~     interviewed in order to evaluate functional outcomes after surgery.~   "
16275|NCT03353922|"~     This is a randomized blinded study to assess the sedative effect of 150 mg TID tolperisone~     and 10 mg TID cyclobenzaprine compared to placebo on simulated driving performance and~     cognitive functioning in healthy adult volunteers.~   "
16276|NCT03353909|"~     Using American Fertility Society classification of intrauterine adhesions, the efficacy of a~     new crosslinked hyaluronan gel in reducing intrauterine adhesion formation after dilatation~     and curettage for delayed miscarriage in women without previous dilatation and curettage was~     examined.~   "
16277|NCT03353896|"~     This pilot clinical trial studies the side effects of NovoTTF-200A device in treating~     patients with newly diagnosed high risk oligodendroglioma. NovoTTF-200A device is a portable~     battery operated device which produces tumor treating (TT)Fields in the body by means of~     surface electrodes placed on the skin. TTFields are very low intensity, intermediate~     frequency electric fields that may slow the growth of tumor cells in patients with high risk~     oligodendroglioma.~   "
16278|NCT03353883|"~     The study intended to include >200 infertile women with impaired ovulation who will be~     subjected to HRT at D-21 of previous menstrual cycle (Group A) or D-1 of menses of~     replacement cycle (Group B). All patients received the same luteal support in the form of~     intravaginal progesterone two day before embryos transfer until blood pregnancy test was~     performed 14 days later. Clinical pregnancy was diagnosed by measurement of β-human chorionic~     gonadotropin level and was confirmed 2-weeks later by TVU.~   "
16279|NCT03353870|"~     The main aim of this project is to analyze and understand the meaning of explicit requests to~     hasten death (euthanasia and assisted suicide) from older people living in an Establishment~     of accommodation for dependent old persons.~      This involves conducting interviews with patients, carers to whom the request has been~     expressed and a relative chosen by the patient. This study aims to describe the request over~     time. This will be done through two series of interviews, one as soon as it is first~     expressed, then one week later.~   "
16280|NCT03353857|"~     Quantify the effect of a probe CYP3A4 inducer (Rifampicin) on the pharmacokinetics of~     levonorgestrel, norethindrone, desogestrel, dienogest, drospirenone,estradiol and midazolam~   "
16281|NCT03353844|"~     Low physical activity is associated with in hemodialysis and hemodiafiltration (HDF)~     patients. Previous studies showed the benefits of intradialytic exercise for improvement of~     physical fitness and hemodialysis adequacy. However, the effect of intradialytic exercise on~     physical activity has not been explored. This current open-labelled randomized controlled~     trial is conducted in HDF patients to determine the effect of intradialytic exercise program~     for 6 months on daily physical activity measured by tri-axial accelerometer (wearable~     device).~   "
16282|NCT03353831|"~     This is a phase III, randomized, partially blinded, multicenter trial to evaluate the~     efficacy and safety of atezolizumab plus bevacizumab and chemotherapy compared to placebo~     plus bevacizumab and chemotherapy in patients with recurrent ovarian-, fallopian tube, or~     primary peritoneal cancer with 1st or 2nd relapse within 6 months after platinum based~     chemotherapy or 3rd relapse.~   "
16283|NCT03353818|"~     This a randomised, single-blinded, controlled study that investigate if a free golf training~     programme will increase the physical activity of type 2 diabetes patients.~   "
16284|NCT03353805|"~     The terrorist attack on the ram truck, which occurred on 14 July 2016 on the Promenade des~     Anglais in Nice, involved a significant number of casualties in the civilian population: 86~     dead including 10 children and adolescents, and 434 wounded. The attack harmed families~     gathered for a festive event, the national holiday fireworks, and affected both adults and~     children of all ages. The people directly involved in the attack number in the thousands:~     wounded, threatened with death, bereaved, direct witnesses, workers - including firefighters~     and health personnel (in situations of prolonged extreme tension or insecurity).~      Following the attacks in Ile-de-France in January and November 2015, Public Health France~     conducted in 2015 and 2016 two large-scale studies to estimate the psycho-traumatic impact~     for those involved in the attack, to know the use of care devices to provide useful~     information, and ultimately provide information to improve the management devices in place.~     IMPACTS carried out following the attacks of January, ESPA 13 November carried out following~     the attacks of 13 November 2015, relate to two main types of population:~        -  Non-responders (civilian population) present on or near scenes of crime or their~          relatives.~        -  Persons intervened to secure the premises or provide assistance, or provide~          psychological support the same day or within 3 weeks.~      IMPACTS was conducted face-to-face with investigators and concerned 232 participants, 45~     people of the medico-psychological relief (Samu, Cump, Hôtel Dieu) between 6 and 10 months~     after the events. A second wave of interviews took place from 16 to 20 months after the~     events.~      ESPA 13th November took place via a web-based questionnaire and 800 participants took part,~     including 67 CUMPs, 121 hospital staff and 26 people from Samu between 9 and 12 months after~     the events.~      Based on the expertise of Public Health France and the model developed for the ESPA study on~     November 13th, the Public Health Department of the University Hospital of Nice wished to~     carry out a specific study among the health professionals of the University Hospital of Nice~     and the Hospitals pediatrics of Nice CHU-Lenval, as well as students of the Faculty of~     Medicine of Nice Sophia-Antipolis.~      Many professionals of all categories were directly impacted: either at the scene of the~     attack as a civilian population or as professionals, or in the care services that received~     the victims and families (including services of the Pasteur2 hospital, Lenval Hospital on the~     Promenade des Anglais).~      The population of medical students is also included in the study, and external students in~     particular have made a significant contribution to the Institut Médico-Légal.~      This involvement could be done directly (presence as hospital staff at the scene of the~     attack, care of the victims or their relatives, in the emergency and care services), but also~     indirect (close and knowledge affected by the attack, specific repercussions in the local~     context, forced changes in the organization of work). It is therefore all hospital~     professionals, medical students (external, internal) and paramedical students who will be~     involved in the study.~   "
16285|NCT03353792|"~     To demonstrate that a new insulin pump system can prevent low glucose episodes and improve~     brain function in aged Type 1 diabetes mellitus subjects.~   "
16286|NCT03353779|"~     To identify the optimal cut-off values in different platelet function testing to predict~     MACCE at 12-months in complex PCI patients of China~   "
22707|NCT03269773|"~     This is multi-center, randomized, double-blind, parallel, placebo-controlled phase III~     clinical trial to evaluate the efficacy and safety of FURESTEM-AD Inj. for moderate to severe~     chronic atopic dermatitis~   "
16287|NCT03353766|"~     The aim of this longitudinal randomized investigation is to determine the long-term effects~     of early lateral crossbite correction with Quad-Helix appliance, during the deciduous~     dentition, on craniofacial structures and dental arches, compared to treatment started later,~     after the first permanent molars have erupted.~      The hypothesis is that the timing of treatment has significant effects on orthodontic~     treatment total time, the general outcome of the treatment, and the compliance of the~     patient.~      The Age cohort of five-year-old of children living in the community areas of Oulunsalo are~     screened at the age of 5 years for malocclusions. Of these children 80 children who meet the~     criteria are chosen for the study after the written consent.~      The children are randomized into two groups. In the first group the treatment with Quad-Helix~     appliance is started at the age of 5 to 6 years, before the eruption of the permanent molars.~     The device is cemented to the second deciduous molars. The treatment is continued and~     continued until normal lateral occlusion is achieved and the device is kept stable for one~     year after this.~      In the second group headgear treatment is started after the first permanent maxillary molars~     have erupted. The device is cemented to the first permanent molars. The treatment is~     continued until normal lateral occlusion is achieved and the device is kept stable for one~     year after this.~      In both groups dental casts, cephalograms, and standardized 3D facial photographs are taken~     before treatment (T0), after the first treatment phase (T1), after the second treatment phase~     (T2) and after the growth (T3).~      Facial 3D scanning is performed for all the subjects after the treatment to find out the~     effect of different treatment methods on facial characteristics. The dental casts are scanned~     to make 3D models of the cast to be used in detailed analysis.~      A wide multi-level questionnaire is performed before, during and after the study to the~     parents and the children to find out the comprehensive effects of orthodontic treatment on~     the well-being of the child. The questionnaire includes the Rutter's child behavioural~     pattern (Rutter et al., 2001).~      In both studies, all the guidelines of RCT are applied. Blinding of the clinicians is gained,~     as the orthodontists or dentists treating the children are not aware of the rationale of the~     study. Blinding is applied on all measurement of the documents.~   "
16288|NCT03353753|"~     This is a 2‑arm, randomized, placebo-controlled, double‑blind, international, multicenter~     study comparing the efficacy of DCC-2618 to placebo in patients who have received treatment~     with prior anticancer therapies. Prior anticancer therapies must include imatinib, sunitinib,~     and regorafenib (3 prior therapies). Approximately 120 patients will be randomized in a 2:1~     ratio to DCC‑2618 150 mg QD or placebo~   "
16289|NCT03353740|"~     The investigators are imaging patients with prostate cancer using a new PET imaging agent~     (Ga-68-PSMA-11) in order to evaluate it's ability to detection prostate cancer in patients~     with biochemical recurrence after prostatectomy and radiation therapy.~   "
16290|NCT03353727|"~     This project is working on orthoptic rehabilitation for low vision people. The aim of the~     project is to assess the interest and integration of this rehabilitation device used at home,~     in low-vision private practice and at the hospital. It leads to develop and evaluate an~     innovative device to integrate and adjust monitoring of patients according to their need and~     their progress, to create new interactions with the patient, enabling the orthoptist to stay~     in touch with his patient at home between rehabilitation sessions and to obtain a more fine~     and objective analysis of the exercises done by the patient.~      Using an eye tracker and a digital tactile screen with data uploads allows the practitioner~     to observe the progress objectively. It also leads the patient to a better understanding of~     his/her visual behavior and of the effects of rehabilitation. Therefore, it will be easier to~     adopt better strategies.~   "
16291|NCT03353714|"~     To determine the effect of a bilateral pudendal block on voiding dysfunction following~     midurethral slings.~   "
16292|NCT03353701|"~     The objective for this project is to determine whether how certain behavioral and health~     functions change in persons with heavy drinking when they stop (or reduce) drinking for 30~     days, and whether changes continue for up to 90 days. The study will also identify barriers~     and facilitators related to drinking reduction. The project will focus on clinical~     comorbidities including HIV disease control, cognitive and brain function, liver~     abnormalities, and chronic inflammation. The study teams propose to enroll 140 HIV+ and 40~     HIV- adults with heavy drinking, and then use Contingency Management (CM) with financial~     incentives to encourage participants to maximally reduce alcohol consumption for 30 days.~     Participants will be required to wear an ankle biosensor (SCRAM monitor) at all times, which~     is used to monitor participants' drinking behavior. At 30 days, participants will complete a~     full day of follow-up, including cognitive testing, neuroimaging, blood testing, liver~     Fibroscan, and questionnaires. Many participants will also provide a stool sample for gut~     microbiome assessment at each time point. At 30 days, participants will participate in a~     motivational interview to discuss perceived benefits and obstacles to drinking reduction, and~     most participants will continue CM to 90 days (but can opt out at this point). Participants~     will complete another full-day assessment at 90 days, at which point persons may choose to~     drink or not on their own (no more CM). A final assessment will be conducted at 12 months.~     This A-B-A design will enable us to clearly identify whether alcohol effects on cognition and~     brain function are reversible in the context of HIV, and analyze specific cerebral and~     systemic pathophysiological factors contributing to these effects. The inclusion of HIV-~     adults will enable subgroup comparisons of alcohol reduction effects in the context of HIV~     vs. no-HIV. These HIV-negative participants will be recruited from the same settings as our~     HIV+ participants, and will include a similar proportion by age, race, and gender as the HIV+~     participants. The study team will use information from the MI data and our other assessments~     to elucidate factors that predict both short term (during CM) and long-term (1-year) alcohol~     reductions, and study how changes in alcohol consumption affect important HIV clinical~     outcomes that will be monitored over time.~   "
16293|NCT03353688|"~     The purpose of this study is to investigate the clinical efficacy of directional DBS~     electrode technology and whether electrophysiology biomarkers can predict effective contact~     segments for chronic therapy.~   "
16294|NCT03353675|"~     This is a multicenter, single arm, open label phase II study in treatment-naïve for advanced~     stage of the disease and immunotherapy-naïve patients with advanced non-squamous NSCLC and~     with < 50% of tumor cells expressing PD-L1 by immunohistochemical (IHC) staining.~   "
16295|NCT03353662|"~     To conduct a sub-regional micronutrient survey (SRMNS) assessing the prevalence of vitamin A,~     Zn, and Fe status in the country~   "
16296|NCT03353649|"~     This study aims to examine targets of self-regulatory function among two exemplar populations~     for which behavior plays a critical role in health outcomes: smokers and individual who binge~     eat (BED). This is the second phase of a study that aims to identify putative mechanisms of~     behavior change to develop an overarching ontology of self-regulatory processes.~   "
16297|NCT03353636|"~     The primary objective of this clinical trial is to demonstrate the superiority of Natural~     Calm magnesium powder with respect to absorption when compared to three marketed forms of~     magnesium (two magnesium bisglycinate powders and magnesium citrate capsules). The primary~     endpoints were serum magnesium AUC (0-8h) and urine magnesium AUC (0-8h) after a single dose~     of 150 mg elemental magnesium.~   "
16298|NCT03353623|"~     The investigators proposed a controlled, single-blind, unicentric, crossover, randomized,~     clinical trial to test the effects of immersive virtual environments and wearable haptic~     devices in the rehabilitation of children with neuromotor impairments. In addition, the~     proposed approach was compared with respect to conventional therapy.~      A sample of 8 participants was randomly divided into 2 groups and they attended one of the~     two therapeutic approach for 4 weeks before crossing over and inverting the therapy. Between~     the two interventions, there was a wash out period of 4 weeks.~      The investigators assessed motor abilities of the children with validated clinical scales and~     motion analysis before/after each phase of the study (T0: baseline, T1: after 4 weeks, T2:~     after 8 weeks, T3: after 16 weeks, and T4: up to 24 weeks).~   "
16299|NCT03353610|"~     Paroxysmal supraventricular tachycardia (PSVT) is a sporadic, sudden, and recurring~     tachycardia that is caused by an altered electrical conductivity in the heart. It causes~     palpitations and a rapid heart rate, which may induce fear in the patient and negatively~     impact the patient's quality of life. Therefore, most patients experience not only physical~     symptoms of PSVT, but also dramatic psychological burdens.~      As PSVT drug development efforts advance, it has become increasingly important to document~     the impact of PSVT in a systematic way, in terms of the disease natural history and clinical~     characteristics of PSVT episodes, as well as the psychological impact of the condition as~     reported by patients over time. In order to meet the needs for ongoing, systematic data~     collection on PSVT, a multinational registry, The PSVT Place Registry~     (www.PSVTPlaceRegistry.com), is being implemented and will be initially comprised of data~     entered directly by patients. The long-term registry is designed with a participant-focused~     approach to enable continuity of data collection and minimization of impact from changes of~     participants' health care providers. The registry may be expanded at a later time to include~     physician-reported data.~      The information from the registry is planned to be a resource for participants with PSVT,~     their families and support networks, their doctors, and the research community to better~     understand PSVT-related symptoms and awareness, PSVT diagnoses, patient self-management,~     medical treatments for PSVT, and impact of PSVT on quality of life from the patient~     perspective.~   "
16300|NCT03353597|"~     This trial is designed to study the effects of monthly transfusions of young healthy male~     donor plasma on biological age as assessed by DNA methylation levels, and changes in~     cognitive, renal, and pulmonary function, muscle strength, telomere length, testosterone,~     estrogen, DHEAS, IGF-1, high resolution C-Reactive protein, and expression of P16INK4a in~     peripheral blood T lymphocytes and skin biopsies.~   "
16301|NCT03353584|"~     Acute vaso-occlusive crisis (VOC) is the most common complication in patients with sickle~     cell disease (SCD) and pain related to VOC is often inadequately treated. This is a phase II~     randomized controlled clinical trial evaluating the efficacy of virtual reality technology~     when added to standard pain management for patients with sickle cell disease who are~     experiencing acute pain crisis in the ambulatory care setting. Patients will be randomized to~     receive either standard management only or standard management in addition to virtual reality~     therapy. The remainder of care for the painful event will continue per institutional~     standards according to clinical indication, including reassessment and documentation of pain~     and additional doses of pain medicines by intravenous (IV) or oral route. Pain scores and~     opioid requirement will be measured and compared across treatment arms, along with the~     outcomes of discharge from clinic versus admission to the inpatient unit.~      PRIMARY OBJECTIVE: To assess the efficacy of virtual reality (VR) technology in reducing pain~     at 30 minutes after intervention during an acute vaso-occlusive crisis in patients with~     sickle cell disease. Primary endpoint will be change in pain scores in Standard versus VR~     arms, between the first pain assessment at the time of presentation and the subsequent pain~     assessments up to 30 minutes after intervention.~      Secondary Objectives:~        -  To compare total opioid consumption from the time of presentation to the time of~          discharge from acute care setting in Standard versus VR arms.~        -  To assess the efficacy of virtual reality (VR) technology in reducing pain at 60 minutes~          after the first IV medication administered or 60 minutes after completion VR during an~          acute vaso-occlusive crisis in patients with sickle cell disease.~   "
16302|NCT03353571|"~     The Catheter Science C3 Umbrella Catheter has been developed for management of urinary~     retention in patients who are either using a Foley or Self Intermittent Catheter. This device~     is inserted into the bladder in an extended state and once the stylet is removed the device~     folds into collapsed state. A thread is attached to the device and traverses thru the urethra~     and is attached to a bobber. With gentle traction on the thread the device engages the~     bladder neck and the central tube extends which allows for the flow of urine. Once voiding is~     complete, the thread is released and the device collapses back to the folded state into the~     bladder. Each voiding cycle is accomplished in a similar fashion. This is a novel technique~     in which the bladder is catheterized with the device from within the bladder into the bladder~     neck and urethra. The standard self catheter technique is for placement of a catheter from~     the outside into the urethra and into the bladder.~   "
16303|NCT03353558|"~     Patients with CML report on fatigue, and many of them report on sleep disturbances. The~     investigators wish to objectively assess the patient's sleep using a sleep wrist watch~     (Actigraph) , and correlate data with their perception of sleep quality. A matched~     participants group will serve as control. the Control group is defined as participants not~     having CML or any other malignancy and without any known sleep disturbances.~   "
16304|NCT03353545|"~     The importance of real-world evidence studies stems from the following considerations. The~     study population of a specific clinical trial needs to meet strict inclusion and exclusion~     criteria, which result in a population of participants that is not necessarily representative~     of the study population of interest treated in routine care. Furthermore, the outcomes of a~     clinical trial occur under controlled conditions that do not necessarily reflect the routine~     healthcare practice. This is especially true among patient populations with challenging to~     treat disease such as in MM, where personalized therapeutic approaches are commonly~     considered taking into consideration the patients' age and associated comorbidities, among~     other factors. In addition, observational studies, due to their non-interventional nature,~     often show increased degree of heterogeneity across the enrolled patient populations compared~     to clinical studies, thus aiding generalizability of the results.~      In light of the above and due to the scarcity of evidence regarding the outcomes for patients~     with RRMM receiving Pom/LoDex in routine clinical practice, this retrospective chart review~     and prospective observational study aims to assess the PFS and response to treatment as well~     as to obtain real-world evidence on the utilization patterns and management strategy of~     Pom/LoDex in routine clinical care settings in Greece.~      This is a non-interventional, multicenter, single-country, retrospective chart review and~     prospective cohort study which will include a representative sample of patients with RRMM who~     have been initiated on Pom/LoDex between 01 January 2016 and 28 February 2019 in the third~     line and beyond treatment setting under routine care conditions in Greece.~      The study will be carried out by hospital-based hematology specialists practicing in~     geographically diverse locations throughout Greece and will be conducted under real-world~     conditions of daily clinical practice.~   "
16317|NCT03353376|"~     In this prospective, randomized, non blinded, one center (University hospital) trial, 60~     patients (28 with type 1 and 32 with type 2 diabetes) with a mean duration of diabetes of~     22.5 ± 11.7 years were randomly assigned to group (6 patients per group) or individual usual~     care for one year. Primary end-point included change in Hba1c and visits to out-patients~     clinics, secondary endpoint included change in body mass index, blood pressure levels, waist~     circumference, non HDL Cholesterol, diabetes related and quality of life questionnaires and~     hospitalizations.~   "
16305|NCT03353532|"~     This is a retrospective multinational, multicenter cohort study with a nested case-control.~     The study includes all surgical procedures performed at a participating site to prevent bias.~      Data will be assessed in two populations.~      Cohort population: Export of electronic file data on demographics, surgical procedure ICPM~     code, duration of procedure, American Society of Anesthesiologists (ASA) score, body mass~     index, comorbidity ICD codes, and wound class of all patients undergoing surgery.~      Nested case-control population: For patients establishing S. aureus SSI and 1:1 matched~     controls from the same center further data will be captured: Length of hospitalization,~     length of ICU stay and reason as well as attribution to SSI, survival at 30 and at 90 days,~     antibiotic treatments including duration, functional status at admission and at final~     discharge; necessity for surgical revision, and death attributed to SSI.~      If readmission is necessary, reason and attribution to SSI, length of hospitalization and~     length of ICU stay as well as all antibiotic treatments and their duration will be recorded.~      The cases causative pathogens including resistance patterns and type of SSI according to CDC~     criteria will be captured.~      Matching criteria comprise the following:~        -  Type of procedure~        -  Age~        -  ASA score~        -  BMI~        -  Duration of procedure (as percentile for this procedure)~        -  Diabetes~        -  Sex~   "
16306|NCT03353519|"~     No formal primary care based model of care exists to support stroke survivors living in the~     community. A large variation in the range, quality and access to health services offered to~     stroke survivors between and within local clinical commissioning groups suggests that many of~     the stroke survivors' needs are not being met systematically. Therefore, to address the~     longer term needs we have developed a multi-factorial primary care model that seeks to enable~     greater engagement with stroke care and community services, to link effectively to specialist~     services, and to improve the lives of stroke survivors.~      This will be a two-arm cluster randomised controlled trial. Participating general practices~     will be randomised to deliver either the new model of stroke care or current usual care. The~     aim of this trial will be to assess the clinical and long-term cost effectiveness of the new~     model of primary care for stroke survivors living in the community. The primary outcome for~     the trial will be measured using two sub-scales (emotion and handicap) of the Stroke Impact~     Scale questionnaire at 12 months.~   "
16307|NCT03353506|"~     Fecal microbiota transplantation (FMT) for the treatment of recurrent Clostridium difficile~     infection (RCDI) has traditionally been offered as fecal slurry administered by enema,~     nasogastric tube or endoscopy. Frozen oral capsules have also shown efficacy. The potential~     advantage of lyophilized FMT is the relative ease of manufacturing and storage compared with~     fecal slurry.~      Sterile fecal filtrate has previously been shown to prevent Clostridium difficile infection~     (CDI) recurrence, suggesting that live bacteria may not be needed. This study will compare~     lyophilized sterile fecal filtrate (LSFF) with lyophilized FMT (LFMT) in the treatment of~     recurrent Clostridium difficile infection (RCDI).~   "
16308|NCT03353493|"~     The primary purpose of this study is to investigate neural mechanisms and predictors of~     treatment outcome in Mindfulness-Based Cognitive Therapy (MBCT) for recurrent Major~     Depressive Disorder.~   "
16309|NCT03353480|"~     China Food and Drug Administration (CFDA) initiated a generic consistency evaluation program~     to evaluate the quality and efficacy of the products manufactured in China in 2016. This is a~     reference scaled bioequivalence study to support the program and to demonstrate the~     bioequivalence between the 250 mg azithromycin tablet manufactured at Pfizer Dalian, China~     (the localized originator, Test) and the 250 mg azithromycin tablet manufactured at Pfizer~     Barceloneta, Puerto Rico, US (the originator, Reference) in healthy Chinese subjects under~     fasted and fed conditions. This open-lable, randomized, single-dose 3-way crossover study~     will enroll approximately 33 subjects for each condition. The primary endpoints are~     azithromycin area under the serum concentration-time curve from time zero to 72 hours~     post-dose (AUC72) and Cmax.~   "
16310|NCT03353467|"~     Nasopharyngeal carcinoma (NPC) is most prevalent in eastern Asia, with the highest incidence~     reported among the Cantonese population from the province of Guangdong. Radiotherapy is the~     cornerstone of initial treatment due to the radiosensitive behavior of NPC and its~     deep-seated location. Although radiotherapy has achieved satisfactory results, it can also~     cause some severe adverse events. Currently, surgery is only applied to the treatment of~     recurrent NPC (rNPC) patients, mainly dominated by the conventional open surgery. However,~     the traditional surgery was accompanied by high rate of treatment-induced complications and~     low rate of block removal, which greatly limited the surgical application to the treatment of~     primary NPC.~      With the continuous improvement in surgical techniques, especially the electronic endoscopic~     system to be used in the surgical treatment recently, endoscopic nasopharyngectomy can~     largely overcome these shortcomings of traditional surgery mentioned above.~      In addition, the investigators retrospectively analyzed the survival outcomes of 9 patients~     with NPC (all T1N0M0 according to the UICC / AJCC seventh staging) treated with endoscopic~     nasopharyngectomy in our hospital, with 5-year rate of overall survival, loco-regional-free~     survival, distant metastasis-free survival of 100%. Therefore, the investigators considered~     endoscopic nasopharyngectomy for staged I NPC patients feasible.~      This study will focus on the survival outcomes and quality of life of the staged I NPC~     patients treated with endoscopic nasopharyngectomy.~   "
16311|NCT03353454|"~     The purpose of this study is to determine if the investigational treatment (maralixibat) is~     safe and effective in children and adolescents with Progressive Familial Intrahepatic~     Cholestasis (PFIC).~   "
16312|NCT03353441|"~     The aim of this study is to assess whether intake of Glycine (MSG) leads to an increase of~     cognitive performance after an acute stressor compared to placebo. One group will receive~     verum, one group placebo and one group will not receive any intervention. Cognitive testing~     will be performed in connection with the Trier Social Stress Test (TSST).~   "
16313|NCT03353428|"~     The primary objective of this study is to evaluate the safety of lung cancer specific~     cytotoxic lymphocytes (LC-CTLs). The secondary objectives are to evaluate the rate of~     successful LC-CTLs generation in vitro and determine the anti-lung cancer efficacy.~   "
16314|NCT03353415|"~     The purpose of this study is to see if the use of a continuous glucose monitor by people who~     experience low blood sugars (hypoglycemia) after gastric surgery can help reduce the number~     and severity of low blood sugar episodes.~   "
16319|NCT03353350|"~     Primary Objective:~      To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to~     placebo in glycated hemoglobin (HbA1c) change in participants with T2DM (Type 2 Diabetes~     Mellitus) inadequately controlled with diet and exercise.~      Secondary Objectives:~        -  To compare the effects of once weekly injection of efpeglenatide with placebo on~          glycemic control.~        -  To compare the effects of once weekly injection of efpeglenatide with placebo on body~          weight.~   "
16320|NCT03353337|"~     This study will investigate the effects of aerobic exercise on mental states, cognition,~     BDNF, and long-term outcomes in patients with bipolar disorder.~   "
16321|NCT03353324|"~     Patients with new onset retinal vein occlusion in less than 3 month whom has visual acuity~     less than 20/40 and central macular thickness more than 250micrometer and non perfused areas~     of retina more than 10 DD are included in over study and devided into 2 groups randomizely,~     Group A under gone 3 intravitreal injection of bevacizumab monthly and examine monthly for~     Visual acuity and central macular thickness, if in month four or more the CMT is more than~     250 micrometer and the visual acuity is less than 8/10 the injection is repeated and follow~     up in this manner is continued until 9 months.~      Group B is as the same of group A but patients in this group undergone laser photocoagulation~     of retinal non perfused areas based on FAG wide field imaging .~      After 9 month follow up the outcomes such as Vusal acuity, Central macular thickness,~     intraocular pressure, neovascular formation are compared,~   "
16322|NCT03353311|"~     Enhanced recovery after surgery (ERAS) protocols are programs aiming to implement patients~     recovery following surgical procedures developed about 25 years ago. ERAS protocols are based~     on a multi-disciplinary approach encompassing surgery, anesthesiology, nutrition and nursing;~     each specialty has to fulfill a number of items which have been demonstrated to reduce~     morbidity rates, hospital stay and to implement functional recovery comparing standard~     approach. Accordingly, ERAS society developed a Guidelines for a number of procedures,~     including colorectal.~      The aim of this study is to evaluate the adherence over the last years to these protocols in~     eight Department of Surgery in Rome in a series of colorectal cancer patients.~      Secondary aims are to investigate the correlation of the items adherence with surgical~     outcome and to establish a network of hospitals aiming to promote ERAS approach on a regional~     base.~   "
16323|NCT03353298|"~     Recently there was described an increase in left ventricular mass after kidney donation. It~     is uncertain whether this is reversible or not. Allopurinol lowers uric acid in the blood and~     is normally indicated for gout, but studies have showed that it also can reduce the thickness~     of the left ventricle of the heart in people with heart- and kidney disease.~      The investigators wish to give allopurinol or placebo to kidney donors based on randomization~     and investigate if this has the same effect on kidney donors. The investigators are assessing~     this by performing a cardiac MRI at baseline and after 9 months of treatment. In addition the~     investigators wish to see if allopurinol can have beneficial effects on blood pressure and~     insulin sensitivity as well.~   "
16324|NCT03353285|"~     The purpose of this study is to investigate the impact of follicular flushing on~     fertilization rate in women undergoing IVF treatment~   "
16325|NCT03353272|"~     Background: Despite similar treatment outcomes for surgery or conservative care, the number~     of surgeries for the care of rotator cuff (RTC) related shoulder pain has increased. With the~     increase in surgery, there is an increased risk of harms, increased costs, and high re-tear~     rates. Patient expectations are beliefs or attitudes that include pre-treatment thoughts and~     beliefs regarding the need for specific treatment methods and the timing and intensity of~     these methods. Brief interventions designed to alter and enhance treatment expectations for~     conservative care and have been shown to improve patient expectations, but to date, no~     studies have explored whether such interventions can influence patient decisions to pursue~     surgical care. The investigators propose a comprehensive intervention that involves Patient~     Engagement Education, and Restructuring of Cognitions (PEERC) that is designed to change~     expectations, will reduce the likelihood that patients will choose to have shoulder surgery~     and improve functional outcomes. The cognitive behavioral therapy (CBT) approaches that form~     the core of our PEERC protocol are patient-centered and are designed to empower the patient~     in their own recovery process.~      Purpose/Aims: To examine the effect of the PEERC protocol on the decision to have surgery~     (primary), and improve global well-being, pain catastrophizing, pain, functional outcomes,~     and follow up expectations (secondary).~   "
16326|NCT03353259|"~     Primary objectives of the study are to investigate whether adjuvant treatment in the form of~     Tranexamic acid (Cyklokapron) and Tocilizumab (RoAcmera) to surgery in patients with chronic~     subdural hematomaina can:~        1. effectively decrease the rate of lesion recurrence requiring re-operation,~        2. effectively shorten the time of lesion resolution.~      Secondary objectives of the study are:1) assess the postoperative functional outcome and~     quality of life of participants, 2) assess the postoperative mortality of participants, 3)~     assess the treatment safety data, 4) assess the cure rate of participants.~   "
16327|NCT03353246|"~     The goal of this study is to determine the sensitivity, specificity, and positive and~     negative predictive values of the a portable near-infrared-based device (portable NIR-based~     device), the InfraScanner 2000™, to detect intracranial hematomas (epidural hematomas (EDH)~     and/or subdural hematomas (SDH)) in patients hospitalized at Duke University Hospital (DUH)~     who have sustained or who are suspected to have sustained head trauma and have consequently~     received a brain computed tomography (CT) scan(s).~   "
16328|NCT03353233|"~     The purpose of this study is to learn if using an Interspace between the Popliteal Artery and~     Capsule of the Knee (iPACK) injection technique (also called a nerve block) that numbs the~     nerves going to the back part of the knee to aid in physical therapy after surgery. The iPACK~     technique uses a numbing solution (local anesthetics) that is injected behind the knee to~     reduce pain and to help straighten the knee. This block may affect movement in the leg and~     make the legs weak, but thing is rare. A few institutions use the iPACK block for patients~     having total knee replacements, with the hope of providing good pain relief combined with~     improved mobility after surgery.~   "
16329|NCT03353220|"~     This two-phase study aims to explore ways to predict who will respond well to the weight loss~     drug lorcaserin and to understand the mechanisms that develop which limit drug efficacy.~     Subjects will be recruited for a 5-week crossover study (phase 1) with lorcaserin and placebo~     followed by treatment with lorcaserin for 24 weeks (phase 2).~   "
16330|NCT03353207|"~     Background:~      Previous studies have confirmed that most patients with idiopathic REM sleep behaviour~     disorder (iRBD) eventually develop neurodegenerative diseases. In addition, REM sleep without~     atonia (RSWA), a hallmark of RBD feature, is a significant predictor of development of~     neurodegenerative diseases in patients with iRBD. Some preliminary studies have implied that~     isolated RSWA in the absence of RBD symptoms may also indicate neurodegeneration. However,~     this speculation needs to be confirmed by more refined study with sophisticated measures in~     both RSWA and markers of neurodegeneration~      Objectives: 1) to determine the differences in striatal dopamine transmission and other~     markers of neurodegeneration among individuals with isolated RSWA and healthy controls; 2) to~     examine the correlation of severity of RSWA with striatal dopamine transmission.~      Design: Case-control study~      Setting: Community-based sample~      Participants: 1) iRBD first degree relatives with isolated RSWA (n=18) 2) iRBD first degree~     relatives without isolated RSWA (n=18) 3) Community-based health controls without isolated~     RSWA (n=18)~      Main outcome measures:~        1. The dopamine transmission as measured by triple-tracer PET/ CT imaging protocol~          including 18F-DOPA, 11C-Raclopride and 18F-FDG images;~        2. Brain glucose metabolism and neurocognitive measures;~        3. Severity of EMG activity during REM sleep~   "
16331|NCT03353194|"~     The Canadian Cerebral Palsy (CP) Registry is a confidential, nation-wide collection of~     medical and social information about children with cerebral palsy. The Registry was first~     implemented in 2003 in 6 administrative regions of Quebec and was later extended to~     paediatric centres in Newfoundland, Nova Scotia, Ontario, Alberta, and British Columbia. Over~     1850 children living with Cerebral Palsy have been registered so far. The Registry is the~     first national registry for cerebral palsy in North America.~   "
16332|NCT03353181|"~     The purpose of this study is to evaluate application value of the endoscopic cutting~     technique in the treatment of malignant hilar biliary strictures.~   "
16333|NCT03353168|"~     This is a study of childbirth related anxiety, fear or worry, in which we follow women from~     mid pregnancy until about 8 months postpartum. Our overall aim is to enhance our~     understanding of psychological factors contributing to childbirth related fear or worry.~     Specifically, we wish to investigate~        -  associations between psychological factors (pain catastrophizing, intolerance of~          uncertainty, worry beliefs, cognitive avoidance, insomnia, life satisfaction, anxiety-~          and depressive symptoms, worry parameters, and behavioral avoidance) and childbirth~          related fear or anxiety during pregnancy~        -  the impact of childbirth related fear or anxiety and other psychological factors during~          pregnancy on epidural use during delivery and obstetric outcome variables~        -  childbirth related fear or anxiety during pregnancy, psychological factors, epidural~          use, and obstetric outcome variables as predictors of self-reported birth experiences~          6-10 months postpartum.~        -  childbirth related fear or anxiety during pregnancy, psychological factors, epidural~          use, obstetric outcome variables, and self-reported birth experiences as predictors of~          childbirth related fear or anxiety 6-10 months postpartum~      Women in mid-pregnancy will be recruited at routine check-ups with midwifes working in~     antenatal health care units in two Swedish regions. After consenting to participate, they~     will be answering a questionnaire with sociodemographic and obstetric background data,~     measures of childbirth related fear and anxiety, and measures of psychological variables with~     a potential relation to childbirth related anxiety. 6-10 months after giving birth they will~     be contacted again with a postpartum follow-up questionnaire asking questions about the~     experience of giving birth, postpartum levels of childbirth related fear or anxiety, and~     thoughts about possible future childbirths. They will also be asked if willing to let the~     research team include information from their obstetric medical chart (e.g. birth mode and~     birth interventions, use of analgesia, and complications for the mother and baby) in~     statistical analyses.~   "
16334|NCT03353155|"~     The National University Hospital System has designed and is piloting an improved~     post-discharge care programme called CareHub for patients undergoing cardiac surgery. CareHub~     is a post-discharge care programme that is designed to streamline and better coordinate~     current programmes for patients at high risk of readmission.~      To assess the clinical and cost-effectiveness of CareHub, our team will randomly assign~     patients to a usual care setting or CareHub setting, and measure clinical outcomes, patient~     satisfaction, readmissions, and length of stay through 6 months post-discharge in both~     groups.Patients enrolled in both groups will receive post-discharge care for six months after~     discharge. CareHub patients will receive a single point of contact for access to usual care~     services. Recruitment for this pilot will be from 20 April 2016 - approximately late October~     2016, and the CareHub team will provide 6 months of post-discharge support. The entire pilot~     will thus run from 20 April 2016 - April / May 2017, with data collection extending 6 months~     after the last patient is enrolled.~   "
16335|NCT03353142|"~     Recent research has found that there is moderate evidence for the use of breathing exercises~     for treating chronic, non-specific low back pain. Researchers have found that there were~     significant improvements in pain and quality of life in those suffering with low back pain~     who completed a breathing program intervention. Researchers also found that healthy~     individuals had higher pain thresholds and tolerance following deep and slow breathing~     exercises.~      There are numerous formats of breathing interventions, some interventions that have been used~     with individuals with chronic, non-specific low back pain include: deep breathing, yoga~     breathing, resisted inspiration, and breathe holding. There is moderate evidence to suggest~     the use of these interventions for managing chronic low back pain Another common breathing~     format is Equal-Ratio Breathing. This format requires an individual to inhale and exhale with~     the same duration while gradually increasing the duration of both. This breathing format can~     be easier for patients to perform given the simplicity of the equal inhalation to exhalation~     ratio.~      This research is being done because Equal-Ratio Breathing has yet to be studied in~     individuals with chronic low back pain.~   "
16336|NCT03353129|"~     The overall purpose for conducting this research is to improve the safety and efficacy of~     care for perioperative patients who have developmental delays and behavioral challenges. The~     specific objectives for this study are to describe distress behaviors and interventions used~     in the ACT population. The investigators will also determine the relationship between a~     predictive measure of distress (the Psychosocial Risk Assessment in Pediatrics score) with~     the actual distress behaviors exhibited by patients in the perioperative area. This study~     will provide knowledge that is necessary in order to develop best practices and to guide~     future research for this patient population. Further understanding the techniques used to~     improve care in the perioperative setting may also provide useful information to consider in~     other healthcare settings where this patient population has difficulty with coping and~     cooperating (ex. vaccinations, placing IVs, dental work, etc.).~   "
16337|NCT03353116|"~     The investigator will assess the inverted sequence approach in the treatment of class III~     patient undergoing bimaxillary orthognathic surgery~   "
16338|NCT03353103|"~     This study will assess unstable plaque imaging features by using high resolution MR imaging~     and Sodium Fluoride F-18 PET. This is a comparative study between symptomatic and~     asymptomatic patient referred to carotid endateriectomy, with reference to pathologic~     analysis of plaque components~   "
16339|NCT03353090|"~     Bone scintigraphy is currently a reference test in the initial staging of cancer. Bone~     scintigraphy historically consists in a planar whole-body scintigraphy (WBS). SPECT/CT has~     been shown to dramatically reduce the proportion of inconclusive results and increase the~     specificity of bone scintigraphy. Therefore, in most of nuclear médicine centers, the usual~     protocol for staging of bone metastases consists in a whole-body planar acquisition followed,~     if needed, by a targeted SPECT/CT to characterize suspicious or equivocal uptakes seen on~     WBS. The aim of this study is to assess the incremental diagnostic utility of a systematic~     double-bed SPECT/CT acquisition for bone scintigraphy in initial staging of cancer patients~     compared with the conventional WBS plus single-bed targeted SPECT/CT strategy.~   "
16340|NCT03353077|"~     A unique approach for Skin Squamous Cell Carcinoma treatment employing intratumoral diffusing~     alpha radiation emitter device~   "
16341|NCT03353064|"~     The Hypercapnia Telemedicine Outreach Program (E-TOUCH Study) aims to utilize telemedicine~     technology, as well as emergency medical services (EMS) home visits to address the problem~     with poor follow-up and compliance among Einstein's hypercapnic patients.~      The hypothesis is that reaching out to the subjects' homes will allow more consistent~     healthcare delivery, increase healthcare efficiency and compliance with therapy, and overall~     decrease acute decompensated states / hypercapnic respiratory failure, decreasing ED visits~     and hospitalization.~   "
16342|NCT03353051|"~     The motivation for this study was produced from our preliminary data, which showed that~     during the first 96 hours of life a full-term neonate will actively reduce the overall serum~     iron concentration of their blood and the transferrin saturation decreases rapidly from 45%~     in cord blood to ~20% by six hours post-delivery.~      The Investigators hypothesise that this active sequestration of iron, which results in~     hypoferremia, is done in an effort to limit susceptibility to infection, a process referred~     to as nutritional immunity.~      Currently, little is known about iron regulation and iron homeostasis during the first week~     of life and even less is known about the comparisons of nutritional immunity between full~     term, preterm and low birth weight neonates. Additionally, limited research has been~     conducted on the impact of these processes on bacterial pathogens.~      In an effort to study the neonatal nutritional immunity and its role in neonatal~     susceptibility to infection, The investigator will conduct an observational study in~     full-term, preterm and low birth weight vaginally-delivered neonates born at Serrekunda~     General Hospital, The Gambia.~      The investigators will fully characterise and quantify nutritional immunity during the early~     neonatal period and the investogators will assess how this impacts bacterial growth. Study~     sensitisation will occur at the antenatal clinic, during the mother's second trimester of~     pregnancy. Mothers will be consented and enrolled at delivery. Blood samples will be~     collected once from the umbilical cord and at serial time points from the neonates over the~     first week of life.~   "
16343|NCT03353038|"~     The purpose of this study is to understand the feasibility of using a 3D printer to create~     tailored assistive technology rehabilitation devices. Specifically, we are investigating if a~     tailored 3D printed pillbox is safe, acceptable, and effective compared to an off-the-shelf~     generic pillbox. In this study, approximately 20 people with chronic health conditions who~     use pillboxes will describe their satisfaction and medication adherence with their current~     pillbox using a series of surveys and interviews. Then they will partake in an interview~     about their pillbox, medications, and routines. Based on the interview, the research team~     will 3D print a new pillbox tailored to the participant's preferences, abilities, and~     medication regimen. Then the participant will use the pillbox for 2-8 weeks. At the end, the~     participant will answer the same questions describing their satisfaction and medication~     adherence with the new pillbox using a series of surveys and interviews. This research will~     reveal important knowledge about the potential of 3D printing in the clinic and effectiveness~     of customized assistive technology.~   "
16344|NCT03353025|"~     the study aim to investigate the endocrine remission rate of non-invasive prolactinoma~     between transsphenoidal surgery treatment and Dopamine agonist treatment.~   "
16345|NCT03353012|"~     To study and compare acceptability and tolerance between breast-feeding post-partum woman,~     who receive contraceptive implant 48-72 hours after giving birth or at 5-7 weeks after giving~     birth, using either Levonorgestrel or Etonogestrel contraceptive implant.~   "
16346|NCT03352999|"~     French guidelines for Cardio Pulmonary Resuscitation (CPR) consider Extra-Corporeal Life~     Support (ECLS) as one option in Refractory out-of hospital Cardiac Arrest (ROHCA) patients~     with a no-flow less than five minutes and absence of spontaneous circulation 30 minutes after~     initiation of advanced CPR. Duration of both pre-CPR arrest (no-flow) and of CPR (low-flow)~     have been systematically highlighted as crucial prognostic factors in all observational~     studies focused on ROHCA.~      In order to shorten the time to ECLS initiation, the most recent European Resuscitation~     Council guidelines recommend, in eligible ROHCA patients, a fast track access to ECLS~     implantation.~      CHRU Nancy elaborated an operational strategy which was designed to improve the enrolment of~     eligible ROHCA patients and to reduce the delay time between recognition and ECLS initiation.~      The objective of the present register was to assess prospectively the impact of this new~     operational strategy over a 5 years period.~   "
16347|NCT03352986|"~     BIOCADRE is a CADRE substudy and aims to characterize more precisely the sickle cell patients~     with extreme phenotype.~   "
16348|NCT03352973|"~     This project aims to investigate (1) the behavioral and neural mechanisms of regulation of~     craving in Internet gamers; (2) effects of tDCS over the dorsal lateral cortex on craving and~     regulation of craving in this population. This project will be conducted in Beijing, China,~     based on a large sample of Internet gamers.~   "
16373|NCT03352648|"~     The DERIVATE study was conceived to integrate the information resulted from clinical data,~     transthoracic echocardiography, and cardiac magnetic resonance (CMR) imaging to provide a~     more reliable risk stratification in patients affected by heart failure (HF) and worthy of~     prophylactic implanted cardioverter defibrillator (ICD) therapy. The main purposes of this~     multicenter registry are to: 1) determine CMR findings, and specifically late gadolinium~     enhancement (LGE) features, T1 mapping, and extracellular volume (ECV) that predict sudden~     cardiac death (SCD) and ventricular arrhythmia; 2) provide a comprehensive clinical and~     imaging score that effectively improves the selection of patients who deserve a prophylactic~     ICD therapy; 3) evaluate the contribution of machine learning to predict major adverse~     cardiac events (MACE) as compared to standard clinical scores.~   "
16349|NCT03352960|"~     INMA - INfancia y Medio Ambiente [Environment and Childhood] Project is a research network of~     several Spanish groups that created a project with the aim to study the paper of the more~     relevant environmental pollutants in the air, water and diet during the pregnancy and~     beginning of life, and their effects in the growth and development.~      The INMA Project is based on the experience acquired by groups that studied several cohorts~     with different objectives: the cohort of Riera d'Ebre (n=102), an area with high levels of~     organochlorine compounds and mercury, evaluated the relationship between these exposures and~     the neurological development of the children; the cohort of Menorca (n=492), studied the~     relationship between the early exposure to irritating of the air and allergens with the~     development of allergy and asthma; and the cohort of Granada (n=668), that studied the~     incidence of reproductive disorders in men in relation to the exposure to endocrine~     disruptors.~      Based on the experience of these previous cohorts, other 4 new cohorts were designed to~     evaluate the impact of environmental exposures in children's health: Valencia (n=787),~     Sabadell (n=622), Asturias (n=485) and Gipuzkoa (n=612), that followed the same protocol. The~     population of the study are pregnant women of the general population who lived in each area~     of study (Ribera d' Ebre, Menorca, Granada, Valencia, Sabadell, Asturias, and Gipuzkoa and~     their children. Each cohort had different periods and types from recruitment. In the cohorts~     of Ribera d'Ebre and Granada, the mothers were recruited during the admission to the hospital~     at the moment of the childbirth. In Ribera d'Ebre, the recruitment was between March 1997 and~     December 1999, whereas in Granada it was between October 2000 and July 2002. In Menorca, all~     the eligible women who went to the prenatal visit in some of the sanitary centres of the~     island (private or public) were invited to participate in the study, and the recruitment~     lasted a year starting in July 1997. In the 4 new cohorts the recruitment took place during~     the first prenatal visit (between weeks 10 and 13 of gestation) in the public hospital of~     reference or in the health centre of the area. The periods of recruitment went from February~     2004 to June 2005 in Valencia, from July 2004 to July 2006 and May 2007 to July 2007 (there~     was an additional round of recruitment) in Sabadell, from May 2004 to June 2007 in Asturias,~     and from April 2006 to January 2008 in Gipuzkoa.~   "
16350|NCT03352947|"~     This feasibility study aims to determine if intermittent dosing is deliverable, based on~     patient and professional willingness to take part in a randomised trial evaluating less~     rather than the standard durations of treatment. The trial will evaluate treatment~     compliance, Progression Free Survival and Quality of Life, to inform whether a subsequent~     definitive trial is justified and how it should be designed.~   "
16351|NCT03352934|"~     The purpose of the AveNEC trial is to investigate the clinical activity and safety of~     avelumab in patients with NEC G3 (WHO 2010), including NET G3 who are progressive after~     first line chemotherapy.~   "
16352|NCT03352921|"~     The aim of this study is to compare the effects of clinical pilates exercises and home~     exercise program on postural disorders, pain intensity, normal range of motion, muscle~     strength, endurance, muscle shortness, joint position sense and functional status in desk~     workers with sagittal cervical disorientation.~   "
16353|NCT03352908|"~     The purpose of this study is to determine if the Yale Swallow Protocol is an effective screen~     for aspiration in recently extubated patients.~   "
16354|NCT03352895|"~     Participants'll include 140 adult patients with CKD and receiving hemodialysis in our~     hospital, and divided them into 2 groups. Control group will receive placebo medication~     therapy; resveratrol group will receive oral resveratrol (100 mg per day). All participants~     will receive either treatment for 1year, and receive examinations of pure tone audiometry,~     speech reception thresholds, and speech discrimination score.~   "
16355|NCT03352882|"~     Pilot study examining changes in liver stiffness measured by ultrasound before and after TIPS~     creation~   "
16356|NCT03352869|"~     Compare the therapeutic effects of exenatide, metformin and their combination for 3 months on~     reproductive and metabolic improvements of overweight/obese PCOS patients with impaired~     glucose regulation.~   "
16357|NCT03352856|"~     Aim of the present study is to verify in a double-blind placebo controlled food challenge~     (DBPCFC) test that highly purified barley starch ingredient do not cause allergic reaction in~     subjects most potential to get allergic reaction due to ingredient. Hypothesis is that none~     of the cereal (mostly primarily wheat) allergic subject recruited to the study will obtain~     allergic reaction neither to placebo nor to the test ingredient. Scoring of symptoms during~     the challenges will be based on PRACTALL.~   "
16358|NCT03352843|"~     Background: The World Health Organization has recommended addition of a 0.25 mg/kg~     single-dose primaquine (PQ) to standard artemisinin-based combination therapy (ACT) for~     elimination of malaria in low transmission-settings and for containment in areas threatened~     by artemisinin resistance. However, PQ metabolism is dependent on a highly polymorphic~     cytochrome P450 (CYP) 2D6 isoenzyme which probably compromises the drugs' safety and~     efficacy, particularly in individuals with reduced isoenzyme activity. This trial therefore,~     aims to assess the safety and efficacy of 0.25 mg/kg single-dose PQ when added to standard~     artemether-lumefantrine regimen for clearance and sterilization of Plasmodium falciparum~     gametocytes in patients with CYP450 2D6 reduced/null activity as compared to those with~     normal/increased enzyme activity.~      Methods: On hundred and fifty-five children aged between 1 and 10 years and with~     uncomplicated P. falciparum malaria will be enrolled, treated with standard~     artemether-lumefantrine regimen plus a 0.25 mg/kg single-dose of PQ and then followed up on~     days 0, 1, 2, 3, 7, 14, 21 and 28 for clinical and laboratory assessment. Primaquine will be~     administered together with the first dose of artemether-lumefantrine. Safety assessment will~     be performed using the Primaquine Roll Out Monitoring Pharmacovigilance Tool (PROMPT).~     Gametocytes will be detected and quantified by microscopy and Pfs25 mRNA quantitative nucleic~     acid sequence based amplification (QT-NASBA) on days 0 and 7. For a subset of 100~     participants, post-treatment infectiousness will be assessed by mosquito feeding assays on~     day 7. The CYP2D6 status will be determined using a polymerase chain reaction (PCR) followed~     by a restriction fragment length polymorphism (RFLP). The primary outcome will be the safety~     of single low-dose primaquine in patients with CYP2D6 reduced/null compared to those with~     normal/increased activity.~      Expected outcomes: The findings will provide the much-needed information on the safety and~     efficacy of single low-dose primaquine for clearance and sterilization of P. falciparum~     gametocytes in individuals with reduced/null compared to those with normal/increased CYP450~     2D6 isoenzyme activity prior to the implementation of the treatment policy particularly in~     Africa.~   "
16359|NCT03352830|"~     Household air pollution (HAP) is a top-priority public health problem in developing~     countries. According to the most recent comparative risk assessment, 3.5 million people die~     prematurely each year as a result of HAP exposures. While uncertainties remain regarding~     causal links between HAP exposures and health, the time is ripe for focused research into~     effective interventions. Limited past research has shown that the demand for clean cookstoves~     is low, and that households continue to use traditional hearths even when they have clean~     stoves. The investigators propose to harness an existing cohort in Ghana to study factors~     that increase the adoption of clean cookstoves, and to test strategies to promote adoption~     and continued use.~   "
16374|NCT03352635|"~     The purpose of the study is to collect human biological samples and measurements from people~     of various ethnic and racial backgrounds for projects related to the Mechanisms of~     Ethnic/Racial Differences in Lung Cancer Due to Cigarette Smoking Program Project Grant.~     These samples will be used to evaluate and compare biomarkers of tobacco exposure across~     Japanese Americans, Whites, and Native Hawaiians and to add to the Multiethnic Cohort (MEC)~     biorepository to develop or assess future biomarkers.~   "
16389|NCT03352440|"~     A computer program was developed with the same task, but with two possibilities of user~     interaction: a) interface with contact: in which the individual touches the computer screen~     to finish the task and b) interface without contact: in which the individual perform a hand~     movement in front of the Kinect. Were evaluated 29 individuals with CP who constituted the~     experimental group and 28 individuals without deficiency who composed the control group with~     matching age and sex.~   "
16360|NCT03352817|"~     Sexual health is an important marker of individual quality of life and well-being of~     patients. Sexual dysfunction (SD) is common in patients with heart disease. Screening and~     management are recommended. Cardiac rehabilitation (CR) seems to be a privileged moment to~     address this problem, but the management is often insufficient. The main objective of the~     study was to evaluate the prevalence of SD in patients in CR in the Champagne-Ardenne region.~     Secondary objectives were to describe SD most frequently encountered, to identify risk~     factors of SD, to compare the feelings of patients about their sex life, before and after an~     acute cardiac event and to collect an estimate of the need for care by a dedicated sexology~     workshop. The investigators conducted an observational multicenter prospective study for~     descriptive and analytical purposes after approval by the Institutional review board. An~     anonymous questionnaire was distributed from June 1 to September 1, 2017 in patients~     participating in a cardiac rehabilitation program in the various centers in the region.~   "
16361|NCT03352804|"~     Introduction : The multidrug resistance (MDR) Bacteriae are growing and are a public health~     problem. The known risk factors to be expanding of MDR Bacteriae are: taken antibiotics,~     hospitalization, journey in a country at risk. Other risk factors are emitted in hypothesis~     as the presence of pets.~      Aim : The primary objective is to study the association between the presence of a pet and the~     presence of a MDR bacteria. Methods : Cross sectional study will be performed in Reims~     University hospital in internal medicine ward.~   "
16362|NCT03352791|"~     Alzheimer's Disease and Related Disorders (dementia) poses a significant challenge to our~     public health. While many persons with dementia are cared for by friends and family in the~     community with the assistance of home healthcare and hospice, most clinicians and agencies~     are ill prepared to care for this population and therefore have difficulty assisting patients~     and caregivers in maintaining quality of life leading to adverse patient outcomes, increased~     caregiver stress and burnout, and healthcare utilization. This study will utilize a cluster~     randomized controlled design with 6 care teams at a single study site to examine the ability~     of a multi-component evidence-based practice hospice care quality improvement program for~     registered nurses, social workers and chaplains to improve the quality of life and reduce~     healthcare utilization for persons with dementia and their informal caregiver.~   "
16363|NCT03352778|"~     Irradiation of the parotid gland with subsequent long-term xerostomia is a well-recognized~     complication after radiotherapy for head and neck (HAN) cancers. A number of studies have~     shown that IMRT could minimize the radiation dose to the parotid glands and hence the risk of~     developing xerostomia. The benefit of IMRT has also been demonstrated in prior dosimetric and~     non-randomized studies in NPC patients. In 2007, the investigators have published the~     prospective randomized study of IMRT versus 2DRT in early stage NPC patients. In the study,~     IMRT had lower incidence of observer-rated severe xerostomia, higher parotid and whole saliva~     flow rate, than patients in 2DRT arm at 1 year after treatment. However, there was no~     significant difference in patient-reported outcome, i.e. subjective xerostomia scoring,~     between the 2 arms. The underlying reason for the incoherent findings in terms of objective~     and subjective xerostomia outcome remains uncertain. One of the possible explanations for~     this observation could be the better parotidsparing with IMRT alone may not entirely~     sufficient to maintain oral cavity lubrication while the other mucin-secretory salivary gland~     protection is also essential. Another possible explanation for the insignificant improvement~     in patient-reported outcome with IMRT is the short follow-up time. Gradual recovery or~     improvement in various quality of life parameters was not uncommonly seen several years after~     definitive radiotherapy for HAN cancer patients. There is much interest in studying the long~     term clinical outcome, especially the treatment-related complications, for the patients who~     had randomized and treated in the prior presented prospective study.~      In this study, the long term results, in particular the xerostomia rating will be assessed~     and compared in NPC patients who had participated in the prior reported prospective~     randomized study of IMRT vs 2DRT.~   "
16364|NCT03352765|"~     This study is testing a combination of chemo-immuno therapy called RBM. RBM consists of~     combination of drugs: rituximab, bendamustine, and melphalan followed by reinfusion of the~     participants own stem cells which is called autologous stem cell transplant (ASCT). Compared~     to the standard BEAM regimen, this RBM regimen may or may not be less effective in lymphoma,~     but will likely have fewer side effects.~   "
16365|NCT03352752|"~     This study evaluates the effect of virtual reality technology alleviates the acute pain of~     scar treatment with fractional laser under local anesthesia~   "
16366|NCT03352739|"~     The primary goal of this study is to evaluate the efficacy and safety of the DBS to the~     fornix/NbM among patients who are diagnosed as AD according to a series of evaluations~     including cerebrospinal fluid (CSF) biomarkers and molecular imaging examinations; The~     secondary goal is to compare the efficacy among the two treatment groups of different~     targets.~   "
16367|NCT03352726|"~     The study aims to assess the biological potency of the In-House Reference Preparation (IHRP)~     of peanut allergens extract by a quantitative Skin Prick Test (SPT) method in peanut-allergic~     subjects.~   "
16368|NCT03352713|"~     This study will evaluate the extent to which we can engage and manipulate putative targets~     within the self-regulation domain outside of laboratory settings in samples of smokers and~     obese individuals with binge eating disorder. Fifty smokers and 50 obese individuals with~     binge eating disorder will be recruited to participate in a non-lab experimental paradigm in~     which we will leverage our novel mobile behavioral assessment/intervention technology~     platform. We will measure and modulate engagement of potential self-regulation targets and~     collect data in real time and in real-world conditions. Mobile sensing will be added to up to~     50 of these 100 participants.~   "
16369|NCT03352700|"~     In this randomized controlled study, consecutive outpatients scheduled for elective~     colonoscopy were randomized into two groups. Group A patients (n = 300) used only 3L PEG~     before colonoscopy. Patients in group B (n = 300) were additionally advised to Dyclonine~     Hydrochloride Mucilage plus 3L PEG, The overall quality of colonoscopy cleaning was evaluated~     using the Boston Bowel Preparation Scale by a single endoscopist who was blinded to the~     intervention. Visibility was blindly assessed for the amount of air bubbles and adenoma~     detection rate (ADR). Difficulty of procedure, and adverse events were also evaluated.~   "
16370|NCT03352687|"~     Shoulder surgery is a source of intense postoperative pain that justifies the use of opioids.~     In this context, analgesia provided by locoregional anesthesia (ALR) improves the~     rehabilitation of patients by reducing the length of hospital stay and morphine consumption.~     Thus anesthesia of the brachial plexus interscalene (interscalene block or BIS) is considered~     as the reference technique for the management of post-operative pain after shoulder surgery.~     It is however provider of hemi-diaphragmatic paralysis (PhD) in nearly 100% of cases. Thus,~     this technique is usually avoided in patients with respiratory insufficiency. In arthroscopic~     shoulder surgery, the development of a suprascapular and axillary nerve (SSAX) conjugate~     block appears to be an effective analgesic alternative in this context.~   "
16375|NCT03352622|"~     The pharmacogenomics of the Colombian population with rheumatoid arthritis (RA), understood~     as the individual response to drugs depending on the genome of each patient, can be an~     explanation for the problems of effectiveness and safety that appear during the~     pharmacotherapeutic treatment of RA.~      Currently, there are limited studies on the pharmacogenomics of the Colombian population;~     Therefore, it is necessary to identify and classify the genetic polymorphisms characteristic~     of Colombian patients with RA, which influence the response of methotrexate, infliximab,~     etanercept, adalimumab and thus contribute to precision medicine and medical prescription~     according to the Specificity of the genome of each patient.~      This project aims to determine the association of genetic polymorphisms with the response to~     inhibitors of tumor necrosis factor alpha (TNFα) and methotrexate. To do this, a prospective~     study of cases and controls will be performed in patients in 3 hospital of Colombia with~     pharmacotherapeutic treatment of methotrexate, infliximab, etanercept, adalimumab, in~     monotherapy or combination therapy.~      As a result, it is expected to contribute to the performance of specific genetic tests for RA~     and the generation of a pharmacogenomic basis of the Colombian population with RA.~   "
16376|NCT03352609|"~     The purpose if this study is to determine if five treatments of repetitive transcranial~     magnetic stimulation (rTMS) can reduce craving for cigarettes in smokers. rTMS uses magnetic~     pulses to stimulate the brain and is currently approved for the treatment of major depressive~     disorder.~   "
16377|NCT03352596|"~     Diabetes is one of the most common and chronic diseases in the world, with the prevalence and~     incidence of this disease rising in most societies, especially in Iran. Suitable treatments~     for type 2 diabetes include changing lifestyle with exercise, nutrition, and drug use. New~     research suggests that added sugar, especially fructose, is the main trigger for diabetes and~     pre-diabetes even more potent than other carbohydrates. Fructose has a low glycemic index~     (23μg =) and slowly increases blood glucose levels. Therefore, it is thought that replacing~     fructose instead of glucose can have a positive effect on glycemic control of diabetic~     patients..~   "
16378|NCT03352583|"~     This study will investigate the effects of night time versus day time casein supplementation~     on body composition and athletic performance. Participants will consume the protein~     supplements daily while participating in a supervised, periodized resistance training~     program.~   "
16379|NCT03352570|"~     The purpose of this study is to evaluate theColovac device, a single use, temporary~     intraluminal bypass device,intended to reduce contact of fecal content with an anastomotic~     site, following colorectal surgery (open or laparoscopic).~   "
16380|NCT03352557|"~     To evaluate the safety and tolerability of BIIB092 in participants with mild cognitive~     impairment (MCI) due to Alzheimer's disease (AD) or with mild AD. To evaluate the efficacy of~     multiple doses of BIIB092 in slowing cognitive and functional impairment in participants with~     MCI due to AD or with mild AD. To evaluate the immunogenicity of BIIB092 after multiple doses~     in participants with MCI due to AD or with mild AD.~   "
16381|NCT03352544|"~     The purpose of this randomized controlled trial is to study the effects of exercise on body~     weight, body composition, anthropometric and fasting blood measures, physical fitness,~     pulmonary function, quality of life, and lifestyle habits in patients with severe mental~     illness.~   "
16382|NCT03352531|"~     This study is to characterize the safety, tolerability, pharmacokinetics (PK),~     immunogenicity, pharmacodynamics (PD) and anti-tumor activity of AK105 as a single agent in~     adult subjects with advanced solid tumor malignancies. The study consists of a dose~     escalation phase (Phase 1a) to determine the maximum tolerated dose (MTD), or recommended~     Phase 2 dose (RP2D) for AK105 as a single agent, and a dose expansion phase (Phase 1b) in~     subjects with specific tumor types which will characterize treatment of AK105 as a single~     agent at the MTD or RP2D.~   "
16383|NCT03352518|"~     This clinical study has been launched to collect spectral raman data paired with validated~     glucose reference values in private homes of subjects.~   "
16384|NCT03352505|"~     The present study will analyze if exercise is able to elicit the well-known anti-atherogenic~     effects in patients with SCI. This will be evaluated by measuring vascular parameters such as~     endothelial and inflammatory blood markers, echocardiography of the heart and peripheral~     vessels, as well as blood pressure and arterial stiffness, in subjects performing either~     wheelchair dancing, wheelchair marathon or no sports. Further, it will be investigated,~     whether there is an association between neuroplasticity and cardiovascular health, as~     measured by electroencephalography (EEG), transcranial magnetic stimulation (TMS) and blood~     levels of the brain-derived neurotrophic factor (BDNF).~      We hypothesize that the cardiovascular, physical and psychological benefits of wheelchair~     dancing and/or wheelchair marathon parallel improved neuroplasticity in SCI-patients~   "
16385|NCT03352492|"~     To evaluate the influence of superior versus temporal laser peripheral iridotomy location on~     post-operative visual acuity and contrast sensitivity.~   "
16386|NCT03352479|"~     The opioid epidemic in the United States has become a clear health and safety concern for our~     children and families. Opioids given to our patients for the treatment of pain that go unused~     after the immediate post operative period pose a major hazard when left in the home~     unattended. Opioids can be accidentally ingested by small children or deliberately ingested~     by pre-teens and adolescents leading to major morbidity and or death. Additionally, studies~     have shown that many people addicted to opioids/narcotics have become so due to ingestion of~     medically prescribed drugs. Finally, there has been an increase number of home robberies~     specifically with the intent to steal prescription drugs. Removal of unused medication from~     the home is an important public safety concern to protect our patients, families and friends.~     The Sharps Co (R), offers a product called Takeaway Medication Recovery System. This product~     allows individuals to put unused opioids in a pre-paid envelope which is returned to the~     company through the postal system and properly incinerated. This provides safe disposal in~     accordance with the Environmental Protection Agency (EPA) to protect the water table from~     contamination by drugs disposed of my other means. This system through the Sharps Co would~     allow for de-identified tracking of returned drugs.~   "
16387|NCT03352466|"~     This study is a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation~     clinical trial to evaluate the safety and immunogenicity of NasoShield in healthy adults 18~     to 49 years of age.~   "
16390|NCT03352427|"~     This trial will evaluate the activity of dasatinib in combination with everolimus for~     children with gliomas harboring PDGFR or FGFR alterations.~   "
16392|NCT03352401|"~     The surgical procedures in outpatient surgery are in perpetual increase. However, the peri~     operative stress can reduce the gastric emptying. A patient's compliance for following the~     fasting rules cannot be controlled at home. Ambulatory surgery is currently proposed to~     fragile patients with many comorbidities known to slow gastric emptying. In day case surgery~     the airway management are often managed with supraglottic device ( laryngeal mask). This~     device does not protect the respiratory tract and may expose the patient to a risk of~     inhalation of gastric content (if not empty).~      This study aim to mesure the prevalence of full stomachs in outpatient surgery and to observe~     any changes in anesthetic management secondary to the ultrasound assessment of gastric~     content. It will confront theoretical full stomach risk factors with ultrasound findings. The~     practical and clinical relevance of such a technique in the context of outpatient surgery~     will be assessed in this study. The ultimate goal is to improve the safety of the patient's~     anesthetic management by controlling the risk of pulmonary aspiration.~   "
16393|NCT03352388|"~     Malnutrition or its risk is common among older people, especially among those receiving home~     care services. It impairs the quality of life of the older people and results in significant~     costs to society. To maintain adequate nutrition, increased meal frequency is important. In~     addition to main meals, regular consumption of tasty, convenient, nutrient- and energy-dense~     snacks is recommended. The purpose of this study is to investigate the effects of dairy- and~     berry-based snack consumption on nutritional and functional status and quality of life among~     vulnerable older people at home care.~   "
16394|NCT03352375|"~     The investigators aimed to investigate effects of intubation and laryngeal mask airway usage~     in pediatrics during laparoscopic inguinal hernia repair.~   "
16395|NCT03352362|"~     The purpose of this study is to evaluate the postoperative pain control using non - opioidal~     analgesics in children. We will investigate the effect of single use and combination of~     caldorol(ibuprofen) compare to denogan(propacetamol) in children.~      Participants who receive the laparoscopic inguinal hernia repair between 6 months and 6 years~     old are divided 3 groups(caldolor, denogan, combination). Each groups are received a~     medication by protocol during surgery. After operation patient's pain score and use of~     additional analgesics are recorded in postanesthesia care unit and general ward.~   "
16396|NCT03352349|"~     In this study, investigators aim to screen out the patients with portal hypertension by~     monitoring intraoperative PVP, and to decide the effect of Terlipressinum on the portal~     pressure after liver resection.~   "
16397|NCT03352336|"~     This study will compare an oxygenation test based on arterial blood gas analysis with~     computed tomography for estimating the extent of atelectasis.~   "
16398|NCT03352323|"~     the study will measure the decrease in redness on the face of rosacea subjects~   "
16399|NCT03352310|"~     The study is to investigate the feasibility and safety of autologous umbilical cord blood~     transfusion to treat the newborn infants with presence of clinical indications of neonatal~     hypoxic-ischemia encephalopathy (HIE) and anemia. Umbilical cord blood (UCB) is collected~     following labor and is transfused intravenously within 48 hours after the birth.~      Following the autologous UCB transfusion, HIE subjects will be followed for 2 years for~     survival and neurodevelopmental outcomes and anemia subjects will be followed for 6 months to~     assess the survival and change of hematocrit and hemoglobin levels.~   "
16400|NCT03352297|"~     Quasi-Experimental Study: Unfiltered Nanofat Injected into Postburn Facial Scars Number of~     Patients: 48 Outcome Assessed on POSAS And with Imaje J Scanning Preop And Postop Statistical~     Comparison of Scar Done~   "
16401|NCT03352284|"~     The main objective is to evaluate peri-implant hard and soft tissues's stability with the use~     of a ceramic implant (Implant Straumann®Pure Ceramic) during one year follow up.~   "
16402|NCT03352271|"~     Thrice weekly hemodialysis has been the standard of care all-over the world for end-stage~     renal disease (ESRD) requiring renal replacement therapy (RRT). Despite being in the era of~     precision medicine and individualized healthcare, this program doesn't take into account~     patients with residual kidney function (RKF) who don't require a thrice weekly hemodialysis~     frequency. Incremental hemodialysis (defined as twice weekly hemodialysis initiation in~     incident hemodialysis patients with residual kidney function) has been raised as an~     alternative to the conventional thrice weekly dialysis. Retrospective trials has proved~     safety of a twice weekly initiation with comparative efficacy to the thrice weekly program.~     Despite that, there is paucity of prospective observational and rarity of randomized~     controlled trials comparing both regimens. In this study, the investigators tend to provide a~     more individualized incremental hemodialysis approach to incident hemodialysis patients with~     residual urine volume and RKF. The investigators will compare the results to ESRD patients~     initiating a thrice weekly hemodialysis program.~   "
16403|NCT03352258|"~     Alzheimer's Disease (AD) is the most frequent neurodegenerative disease associated with~     dementia, with a constantly increasing prevalence associated with an aging population.~     Amyloid deposition is considered the first molecular event occurring in AD: as already showed~     in an animal model, a low-dose radiotherapy (RT) course is capable of reducing AD-associated~     amyloid-β plaques and improve cognitive function. This pilot study wishes to investigate in~     10 patients with a diagnosis of prodromal or early probable AD and with evidence of amyloid~     pathology the effectiveness of a short course low dose RT radiotherapy to reduce amyloid~     deposits in the human brain using molecular imaging (18F-Florbetapir) to show the~     effectiveness of the treatment on the specific target.~   "
16404|NCT03352245|"~     The investigators will evaluate the feasibility of implementing a low-intensity,~     patient-centered activity regimen (PCAR) that prioritizes education and communication over a~     12-week period in advanced stage lung cancer patients. The primary outcomes will include~     number of patients increasing their overall step count over the study period and adherence to~     step count recommendations. Secondary outcomes will include quality of life (QoL), dyspnea,~     and depression scores before and after the intervention as well as a patient feedback~     questionnaire (to guide further interventions). The goals are to increase overall step count~     and obtain adherence of >50% of participants.~   "
16405|NCT03352232|"~     To study safety, feasibility and outcomes of combining osteopathic manipulative therapies~     with hyperbaric oxygen therapy in reducing the functional deficits in stroke survivors in~     subacute and chronic phases post ischemic stroke. To document the same as part of a pilot~     project in anticipation of further investigational studies.~   "
16406|NCT03352219|"~     African Americans have considerably higher rates of HIV infections than do White, Hispanic,~     Asian, and Native Americans. African Americans accounted for 59% of all diagnoses of HIV~     infection among youth (13-24 years of age) in the United States. Young African Americans also~     have disproportionately high rates of other sexually transmitted infections (STIs).~     Therefore, the broad, long-term objective of this research is to identify interventions to~     reduce the risk of HIV and other STIs among young African Americans. Entertainment-education~     refers to narrative interventions designed to change behavior while providing entertainment.~     Several studies have evaluated the impact of media content on HIV risk behavior. One study~     found that exposure to an entertainment-education based HIV testing campaign was associated~     with increases in HIV testing among sexually active teens 12 months post exposure. Similarly,~     a radio soap opera called Twende na Wakati became the most popular television show in~     Tanzania and was highly successful in reducing the number of sexual partners and increasing~     condom use. A narrative video intervention study in STI clinic waiting rooms in three U.S.~     cities found a significant reduction in STI re-infection among patients visiting during~     months when the video was shown compared with patients visiting during months when it was not~     shown. Although these studies show that entertainment-education can be a promising medium for~     behavior change, none of them evaluated the efficacy of a tailored online~     entertainment-education intervention specifically designed for African American youth. To~     address this gap in the literature, this study tested the preliminary efficacy of an~     innovative, theory-based HIV risk-reduction serial drama intervention, Reality Check,~     specifically tailored to young African Americans. We used a randomized controlled trial,~     allocating African Americans 18 to 24 years of age to Reality Check, or an attention-control~     intervention promoting physical activity. Each intervention was delivered as a series of~     videos streamed online and accessible via any Internet-capable device. Participants completed~     surveys online at baseline, immediately post intervention, and 3 months post intervention. We~     hypothesized that, Reality Check would reduce condomless sex during the 3-month~     post-intervention period compared with the attention-matched control group, adjusting for~     baseline of the criterion.~   "
16407|NCT03352206|"~     This study will assess the impact of 2-drug (DA) or 3-drug (IDA) regimens on lymphatic~     filariasis infection parameters in communities. Parameters measured will include: circulating~     filarial antigenemia (CFA) assessed with the Filariasis Test Strip (FTS), antifilarial~     antibodies tested with plasma and microfilaremia (assessed by night blood smears and~     microscopy).~   "
16408|NCT03352193|"~     This is an observational pilot study investigating the effectiveness, safety and specific~     immunological mechanisms of Specific Oral Tolerance Induction (SOTI) in children aged 2-16~     years with IgE-mediated wheat allergy. The study will be conducted in the Department of~     Allergy and Clinical Immunology, 2nd University Pediatric Clinic of Panagiotis & Aglaia~     Kyriakou Children's Hospital, Athens, Greece.~      The study will include 10 patients with persistent IgE-mediated allergy to wheat, who will~     undergo 1-year home SOTI, defined as SOTI group. Moreover, 5 patients with IgE-mediated~     allergy to wheat will be followed for 1-year period after their diagnosis, without any~     intervention, either because of denial or due to positive history of severe anaphylaxis to~     very low doses of wheat during baseline Oral Food Challenge / OFC or home ingestion in the~     preceding 3 months. These will be defined as historical control group.~      Well-cooked wheat spaghetti will be given daily to patients with a programmed weekly dose~     increment for 27 weeks (up-dosing phase). Three different home starting doses will be~     pre-determined in accordance to each individual's reactivity threshold during baseline OFC to~     wheat. Each proposed starting dose will be associated with a different weekly stable increase~     ratio of wheat intake, so that all patients reach an equal predefined maintenance dose at~     week 27 of up-dosing phase.~      Subsequently, wheat protein maintenance dose (spaghetti or equivalent quantity of wheat~     protein of other wheat product) will be received daily for additional 6 months (maintenance~     phase), while afterwards patients will be clinically assessed and a 2nd OFC at a higher~     cumulative dose of wheat protein will be performed, in order to assess patients'~     desensitization to wheat.~      Skin Prick Tests (SPTs) to wheat, blood sampling for the determination of total IgE, wheat~     specific IgEs (f4, f79, f98, f416, f433) and wheat Basophil Activation Test (BAT) will be~     performed at baseline, when patients reach the maintenance dose and before the 2nd OFC.~     Additionally, blood sampling for determination of the levels of anti-tissue transglutaminase~     (tTG)-IgA/IgG and anti-endomysial (EMA)-IgA antibodies at baseline and post study completion~     will be performed.~      Regarding historical control group the same testing (except anti-tTG and anti-EMA) will be~     performed at baseline visit and at re-evaluation (post 12 months). All children and / or~     their parents / legal guardians will be trained in the use of self-injectable epinephrine in~     case of severe allergic reactions and a detailed treatment plan will be given by the study~     doctors Written information sheet will be provided and written consent will be obtained from~     all parents/legal guardians.~   "
16409|NCT03352180|"~     Do concomitant subscapularis tears in large to massive rotator cuff tears affect~     postoperative functional and structural outcomes?~      Background and purpose:~      The subscarpularis tendon is essential force maintaining normal glenohumeral biomechanics.~     However, there are few studies which have addressed the outcomes of tears extending to the~     subscapularis tendon in massive rotator cuff tears. The purpose of this study was to assess~     the clinical and structural outcomes of arthroscopic reapair of massive rotator cuff tears~     involving the subscapulrais.~   "
16410|NCT03352167|"~     The spread of multiresistant bacteria is an increasing problem which will mean increased~     costs, morbidity and mortality in the coming years. Emergency departments (ED) play a key~     role in the early identification and management of patients who are carriers of~     multiresistant bacteria, but today there is very limited knowledge about both prevalence in~     the EDs and risk factors for the carrier status of methicillin resistant Staphylococcus~     aureus (MRSA), extended spectrum beta lactam producing enterobacteria (ESBL), vancomycin~     resistant enterococci (VRE), carbapenem resistant enterobacteria (CPE) and toxin-producing~     Clostridium difficile (CD). This knowledge is necessary to prioritize and target the~     preventive response to the spread of multiresistant bacteria.~      The aim of this project is to provide a comprehensive overview of prevalence and risk factors~     for carrier status at a national level, and to develop screening tools for early~     identification of MRSA, ESBL, VRE, CPE and CD carriers among patients admitted to Danish~     emergency departments.~      For hospitalized patients in 8 emergency departments in 4 Danish regions, a total of 10,600~     patients are asked for possible risk factors for resistant bacterial carrier status, and are~     swabbed in the throat, nose and rectum openings and examined for MRSA, VRE, CPE, ESBL and CD~     with the same analytical method of 4 clinical microbiological departments.~      The results are analyzed so that the prevalence of resistant bacteria can be described at the~     hospital level, regional level and national level. Risk factors are analyzed for~     applicability for carrier identification, and based on this, screening models for the~     identification of carriers are developed.~      The vision for the project is that, based on the collected data, a comprehensive picture of~     the extent of the problem in Denmark can be drawn up and new screening tools for early~     identification of carriers can be developed so that the intra-hospital spread of resistant~     bacteria can be met through early intervention with infectious hygiene measures.~      The project has been granted a grant of DKK 3,000,000 from the Ministry of Health and the~     Elderly on December 7, 2016 and DKK 554,871 from the Region of Southern Denmark on 28 August~     2017.~   "
16411|NCT03352154|"~     Bilateral severe to profound hearing loss is a socially disabling handicap. Cochlear implants~     can be used to improve hearing in cases where conventional hearing aids are not effective.~     There are few studies about the long latency Auditory Evoked Potential (P300), in individuals~     with hearing loss and Cochlear Implant (CI) users. The aim of this project is to study the~     behavior of P300 in users of unilateral CI.~   "
16412|NCT03352141|"~     The purpose of this study is to evaluate the safety and efficacy of non-invasive reduction of~     subcutaneous fat along the jawline with Cryolipolysis.~   "
16413|NCT03352128|"~     To assess whether creatine could play a significant role in postponing mental fatigue. To do~     so the investigators will seek to increase brain creatine concentration via a creatine~     supplementation protocol.~   "
16439|NCT03351790|"~     This study seeks to establish factors that influence the view at endoscopy. To achieve this~     patients, who have been already booked for endoscopy, will complete a questionnaire prior to~     their procedure. Demographic and endoscopist factors will also be ascertained.~      The view at endoscopy will then be reviewed and scored against a rating scale, which will be~     validated as a first phase of the study. Factors can then be sought that are associated with~     a good endoscopic view.~   "
16440|NCT03351777|"~     The purpose of this study is to determine whether PR022 Topical Gels are safe and effective~     treatments for mild-to-moderate atopic dermatitis (AD).~   "
16414|NCT03352115|"~     Tonsillectomy is one of the most common surgical procedures in the United States, and~     post-operative pain management is a challenge for otolaryngologists. A 2013 black-box warning~     on codeine following tonsillectomy has drawn attention to potential concerns with all~     narcotics in these patients, and many surgeons try to avoid narcotics. The use of~     intra-operative corticosteroids has been proven to be beneficial in reducing post-operative~     morbidity, and some small studies have shown possible benefit to the use of post-operative~     oral corticosteroids as well, although the results of these studies are mixed. To date, no~     one has looked at whether the use of post-operative oral steroids may reduce or eliminate the~     need for narcotics. We aim to determine whether the addition of oral steroids to our~     post-operative pain regimen can reduce the need for narcotic pain medications.~   "
16415|NCT03352102|"~     Subjects in MV will be included, divided into 3 groups: (a) Control Group (CG), (b)~     Stimulation of Quadriceps (Quadriceps Group - QG), (c) Stimulation of Diaphragm (Diaphragm~     Group - DG). The QG and DG patients will receive consecutive daily electrical stimulation~     sessions at specific points from the first day of randomization until ICU discharge.~     Respiratory and peripheral muscle strength, MV time, length of hospitalization and functional~     independence score (the Functional Status Score-ICU) will be recorded.~   "
16416|NCT03352089|"~     Aortic stenosis is the most common valve disease requiring surgery in the Western world. It~     is defined by progressive calcification and fibrosis of the valve leaflets and restricted~     valve opening. This in turn exposes the heart muscle (left ventricle) to increasing pressure~     leading to heart muscle thickening (left ventricular hypertrophy, LVH) to normalise wall~     stress and maintain heart output (stroke volume). The only treatment available is relief of~     pressure overload by surgical or minimally invasive valve replacement (TAVI).~      Transthyretin (TTR) amyloidosis is a condition characterised by deposition of insoluble~     transthyretin protein (a small protein tetramer produced in the liver) in various tissues,~     predominantly in the heart. Although there are inherited forms caused by specific TTR gene~     mutations, most cases occur in older individuals with non-mutated TTR (wild-type). The~     finding of TTR plaques in elderly individuals is relatively common; in a post-mortem study~     22-25% of patients over the age of 80 had evidence of cardiac amyloid deposition. However,~     there is significant progressive amyloid accumulation in a small percentage of individuals~     leading to heart muscle thickening and heart failure. No medical treatments are currently~     licensed although several agents are at advanced stages of clinical trials.~      As both the above conditions are increasingly common in the elderly population and~     characterised by increased heart muscle thickening, there is the potential for them to~     coexist unrecognised in individual patients. The prevalence of cardiac amyloidosis in~     clinical populations with significant aortic stenosis is not known however small series have~     estimated somewhere in the region of 6-29%. Other data have suggested that patients with~     aortic stenosis and concurrent cardiac amyloidosis have an adverse prognosis even despite~     AVR. It is therefore important to identify aortic stenosis patients with coexistent~     amyloidosis both in terms of predicting prognosis and because it may influence decisions~     about whether to proceed to valve intervention.~      PET/MR is an emerging technique, which combines the excellent temporal and spatial resolution~     of MRI with the sensitive molecular imaging of PET. PET/MR has significant advantages over~     PET/CT (the currently more widely used approach) in that it offers superior tissue~     characterisation, improved correction for cardiac and respiratory motion and major reductions~     in radiation exposure. Whilst there are concerns about its ability to provide reliable~     attenuation correction of the PET data, these issues appear to have been largely overcome~     with recent techniques proposed by our group. MR is also more naturally suited to the imaging~     of certain tissues in the body compared to CT including the left ventricular myocardium.~      In aortic stenosis, MRI has become the gold-standard technique for examining the heart muscle~     (myocardium) with the unique ability to assess its tissue composition. In particular both~     late gadolinium enhancement (LGE) and T1 mapping based techniques are able to detect heart~     scarring (fibrosis) which act as biomarkers of left ventricular decompensation and are~     strongly associated with poor patient outcomes. CMR is also the gold-standard non-invasive~     technique for detecting cardiac amyloid, which is associated with both a characteristic~     pattern of LGE and high native T1 values. However it is not currently able to differentiate~     between the two different types of cardiac amyloid TTR and AL amyloidosis, which have~     different prognoses and treatments. Preliminary studies conducted by our group have suggested~     that 18F-NaF PET when added to CMR can make this distinction on the basis that this tracer~     binds to TTR deposits but not AL deposits, may be able to differentiate between the two.~     Importantly we have also used the same PET tracer as a marker of calcification activity in~     the aortic valve, demonstrating its ability to predict disease progression and cardiac~     events.~      In this study, we will investigate whether PET/MR could be used as one-stop imaging in~     aortic stenosis in whom valve intervention is being considered to assess in detail functional~     and structural properties of both the valve and myocardium and identify cases of significant~     cardiac TTR amyloid deposition.~   "
16417|NCT03352076|"~     A Comparative, Open-Label, Randomized, Parallel Group Study to determine Intraperitoneal~     fluids, tissue, and serum concentrations of VML-0501 following five days of daily vaginal~     applications of single dose of VML-0501 (100 mg Danazol), in comparison to five days of~     Danazol treatment administered as an oral capsule (Danatrol) at a daily dose of 600 mg, in~     two groups of twelve each consisting of women with suspected or confirmed endometriosis and~     scheduled for laparoscopy.~   "
16418|NCT03352063|"~     Prolonged sitting has been shown to effect the response to a high fat tolerance test (HFTT)~     after acute exercise. This study will evaluate the effect of prolonged sitting on response to~     a HFTT after a short term training period.~   "
16419|NCT03352050|"~     The Investigator will compare the effect of mushrooms to ground beef in an intervention study~     and measure satiety markers and gut health markers~   "
16420|NCT03352037|"~     The overlap of morphological imaging features results in many incidentally detected~     pancreatic cystic neoplasms going undiagnosed, including benign serous cystic neoplasms (SCN)~     and potentially malignant mucinous lesions (nonserous). The diagnostic ambiguity then lead to~     invasive procedures such as endoscopic ultrasonography (EUS), unwarranted surgical resection~     on SCN lesions or the need for long term periodic surveillance with delayed diagnosis of~     potentially malignant nonserous lesions. Therefore, precise differentiation of SCN from~     nonserous cystic neoplasms is highly desirable.~      The 18F-fluorodeoxyglucose (FDG) accumulation in tumor cells, which is induced by high~     expression of glucose transporter proteins (mainly include GLUT-1 and -3), can be used to~     discriminate malignant and benign pancreatic cystic tumors in positron emission tomography~     (PET) imaging. GLUT-1 expression has also been documented in benign SCN while no such~     evidence exists in potentially malignant nonserous cystic neoplasms. Based on this evidence,~     investigators will conduct a pilot study to evaluate if integrated 18F-FDG PET/MR imaging~     with simultaneous MR and PET acquisition is helpful in differentiation of SCN from nonserous~     lesions.~   "
16421|NCT03352024|"~     One of the missions of the Memory of Resources and Research Center (CMRR) is to establish a~     diagnosis of expertise in patients with amestic, language or behavioral cognitive complaint.~     Thanks to the dosage of specific biomarkers in the cererbrospinal fluid (CSF), it is~     currently possible to determine the underlying process of the disease in vivo by assess the~     pathological amyloid and Tau profile. To obtain these very sensitive and specific biomarkers,~     clinicians need to perform lumbar puncture (LP). . This exam is easy and reproducible but the~     gesture image remained negative despite some advances in the materials and care..~      Within the Department of Neurology of Montpellier, the recommendations of the Haute Autorité~     de Santé (HAS) about pain management in adults are applied. A transdermal device of~     lidocaine-pilocaine (type EMLA) is applied 120 minutes before the LP . In addition, an~     equimolar oxygen-nitrous oxide (MEOPA) mixture could be added. Then, patients benefit from a~     helping relationship before and during the gesture dedicated to reduce anxiety.~      Until recently, non-medicinal techniques (relaxation, hypnosis ...) were not recommendedin~     cases of major anxiety or analgesia deemed insufficient. Many studies have shown the~     efficiency of hypnoalgia in invasive gestures in young children. The University Hospital of~     Montpellier have developed training about hypnoanalgesia and have been implemented for~     patients with neurological disorders in our unit. A reduction and even a suppression of pain~     and a limitation of the apprehension of the gesture have been judged satisfactory both for~     the patient, the practionner and the nurse practicing regularly the LP. However, this~     evalusation remained subjective and clinically-based. Thus, it seems relevantto analyse the~     effect of this technic in order th test the following hypothesis: hypno-analgesia~     (non-medicinal technique of care) associated with EMLA patch is more effective than the~     helping relationship associated with EMLA patch to reduce the pain that may inverse during~     the LP for diagnosis in patient with mild to moderate stage of Alzheimer's disease.~   "
16422|NCT03352011|"~     The proposed study supports a line of research that seeks to improve the health of military~     veterans with post-traumatic stress disorder (PTSD) by teaching them mindfulness skills. The~     proposed study first gathers Veteran's Affairs mental health provider and peer support~     specialist feedback to adapt a brief mindfulness intervention and then investigates the~     feasibility of testing this intervention in a small randomized clinical trial. The study~     targets primary care patients with PTSD who may be reluctant to engage in other mental health~     treatments and provides them with mindfulness training to reduce PTSD symptoms, improve~     psychosocial functioning and increase hope for recovery.~   "
16423|NCT03351998|"~     The purpose of this study is to test how different doses of a statin, Lipitor, affect muscle~     health and function, and cardiovascular fitness.~   "
16424|NCT03351985|"~     Delirium is the most common neurological complication of cardiac surgery patients and~     associated with poor prognosis. In recent years, the important role of quantitative~     electroencephalogram (qEEG) in brain function monitoring is becoming increasingly prominent.~     The purpose of this study is to evaluate the effect of qEEG in predictive of post-operation~     delirium and prognosis of cardiac surgery patients.~   "
16460|NCT03351517|"~     The study intends to evaluate the efficacy of Tapentadol against placebo as a preemptive~     analgesic in the management of post-operative pain in the patiens undergoing total knee~     arthroplasty.~      The primary objective is to evaluate th epain score in visual analogue scale at various time~     points within 24 hours post operarively~   "
16461|NCT03351504|"~     This study evaluates the impact of a solar lighting system on kerosene lamp use, levels of~     indoor air pollution, and health in women living in rural Uganda. Half of the participants~     will receive the lighting systems immediately, while the other half will receive them after~     an 18 month delay.~   "
16425|NCT03351972|"~     The introduction of video capsule endoscopy in 2000 has provided a convenient and minimally~     invasive imaging method for the whole small bowel. Capsule Endoscopy is used to investigate a~     number of conditions such as obscure gastrointestinal bleeding, iron deficiency anaemia,~     inflammatory bowel disease, celiac disease, small bowel tumors, and hereditary polyposis~     syndromes. However, Capsule Endoscopy capsules are not able to suction fluid or wash the~     intestine, thus making it susceptible to decreased visualization quality and diagnostic yield~     due to dark intestinal contents or air bubbles. In order to determine the best method for~     bowel preparation before Capsule Endoscopy, this study seeks to determine in patients~     undergoing small intestine Capsule Endoscopy if split dose Polyethylene Glycol or single~     morning dose of Polyethylene Glycol have a benefit in Visualisation quality when compared to~     clear fluids only. A co-primary outcome will also be the diagnostic yield, as measured by the~     aggregate of all the active preparation groups compared to than clear fluids only group.~     Secondary outcome measures will include tolerance of preparations, cleanliness as assessed by~     a validated 4 point scale, distal small bowel visualization (the last 1/4 of small bowel~     examination by time) and small bowel transit time (measured as time from first duodenal image~     to first cecal image). Adult outpatients referred for small bowel video capsule endoscopy~     will be considered for the study and this will run in the clinical environment as per~     routine. Patients will have been referred for capsule endoscopy as per normal clinical~     practice so not additional procedure will take place. Patients will be randomly assigned to~     in a one to one fashion to one of three groups in order to explore whether bowel preparation~     (either as a single or divided dose) produce better cleansing and diagnostic yield than no~     preparation at all in small bowel capsule endoscopy.~   "
16426|NCT03351959|"~     Background. About 20% of rectal cancers who underwent neoadjuvant treatment (neoCHT-RT)~     achieve a pathological complete response in the surgical specimen(ypT0); however, about 10%~     of ypT0 present metastatic nodes (N+). Although seldom analyzed, ypT0N+ identification could~     be crucial in order to tailor treatments.~      Hypotheses. The two hypotheses to test are if we can identify ypT0N+ and if N+ is an~     independent prognostic factor.~      Aim 1. To create a large Database (DB) of ypT0. Aim 2. To compare ypT0N0 vs ypT0N+ with~     respect of their clinical/radiological/molecular features.~      Aim 3. To investigate long term results. Preliminary Study. Dr Lorenzon is the PI of an~     Italian retrospective multicentric study conducted on 260 ypT0 focused on treatment and~     outcomes.~      Design. The PI will operate in partnership with the European Society of Surgical Oncology~     (ESSO). A DB will be used by ESSO-affiliated centres for collecting the clinical,~     pathological and radiological data of ypT0N0/N+, previously treated (last 5 years) and~     prospectively enrolled (6 months + 2 years of follow-up); each centre will provide a junior~     (<40 yrs) member for data collection and a senior investigator .for data validation; all the~     analyses will be centralized by the PI. ypT0N0 and ypT0N+ will be compared for the~     clinical/pathological variables, for the gene expression profiles of pre-neoCHT-RT biopsies~     (grant requested). Uni-multivariate survival analyses (end-points: OS, DFS, DSS) will be~     conducted at 2 years of follow-up.~      Impact. This is the first study aimed to investigate ypT0N+ features; their accurate~     identification could lead to treat safely thousands of ypT0N0/year with local excisions~     leaving major surgery for N+ patients. Results will change practice and reduce considerably~     health-related costs; moreover, the molecular profiles will open new frontiers of research.~   "
16427|NCT03351946|"~     A study on healthy patients undergoing anesthesia for non-abdominal surgery - evaluation of~     positive end-expiratory pressure versus zero positive end-expiratory pressure on the amount~     of atelectasis in the early postoperative period.~   "
16428|NCT03351933|"~     This is a single center, open-label, single-arm study in which approximately 28 Hepatitis A~     virus (HAV)-seronegative healthy subjects will be enrolled. There will be a screening period~     of up to 28 days during which subjects will be screened for enrollment in the study.~      Healthy subjects will receive a single intramuscular (IM) dose of GamaSTAN (0.2 mL/kg),~     followed by a pharmacokinetic (PK) sampling period of 150 days (approximately 5 half-lives).~     The protective levels of anti-HAV antibodies will be assessed up to 60 days after the~     administration of GamaSTAN. A PK curve will be obtained during the PK sampling period.~   "
16429|NCT03351920|"~     To prospectively assess the mechanical ventilation management when its provided by Emergency~     Physicians in French Hospital, and to assess complications and outcome of these patients.~      The study could be measure the proportion of patients developing an Acute Respiratory Failure~     Distress after a take care of by French Emergency Departments.~   "
16430|NCT03351907|"~     Patients with cardiovascular diseases from Guangdong province will be recruited and followed~     up for at least 4 years to evaluate the risk factors for cardiovascular-related mortality and~     disability. Physical examination, questionnaire survey and biological sample collection will~     be conducted at baseline and the incidence of all-cause and cardiovascular mortality will be~     investigated during follow-up.~   "
16431|NCT03351894|"~     This study is aimed to compare the clinical outcomes in Ziemer LDV Z8 femtosecond~     laser-assisted cataract surgery versus conventional phacoemulsification cataract surgery~   "
16432|NCT03351881|"~     People make decisions every day, both for themselves and on behalf of others. In the case of~     organ donations, despite the opt-out systems used in Singapore where the default is a~     presumed consent on the part of the individual, the actualized donation rate is lower than~     expect. This is partially because family members are called in to make surrogate decisions on~     behalf of the patient, especially patients near brain death or have been certified to be~     brain dead.~      To address the shortfall in organ donations, the investigators plan to run three studies:~        -  First, the investigators seek to conduct a representative survey of the public's~          perception towards organ donation. The investigators will focus on their views towards~          donating their own vs. family members' organs, and to explore the role of cultural~          influences on decision-making.~        -  Second, the investigators will conduct the survey focusing on NUS students and the ways~          they respond to an opt-out, opt-in, or mandatory organ donation system.~        -  Third, the investigators will conduct the survey on an online platform (MTurk) to gather~          the views of participants across India and USA about organ donation.~      The studies have the potential to improve actualized organ donation rates, as well as to~     inform the medical community in their communication with family members.~   "
16433|NCT03351868|"~     This is a Phase I/II clinical trial of gene therapy for treating Fanconi anemia using a~     self-inactivating lentiviral vector to functionally correct the defective gene. The~     objectives are to evaluate the safety and efficacy of the gene transfer clinical protocol.~   "
16434|NCT03351855|"~     The purpose of this clinical trial is to evaluate the safety and efficacy of IV-infused~     autologous or allogenic HPV-CTLs.~   "
16435|NCT03351842|"~     Randomized phase II trial aims to compare surgery with or without adjuvant chemotherapy in~     treating patients who are pathologically diagnosed as stage I lung adenocarcinoma with~     micropapillary component no less than 20%.~   "
16436|NCT03351829|"~     This is a Phase I/II clinical trial of gene transfer for treating Beta-thalassemia using a~     self-inactivating lentiviral vector to functionally correct the defective gene(s). The~     objectives are to evaluate the safety and efficacy of the gene transfer clinical protocol.~   "
16437|NCT03351816|"~     The Biorhythm study aims to investigate the utility of new biomarkers (e.g. MR proANP, ST2)~     measured pre-procedure for the prediction of procedural success in patients with atrial~     fibrillation undergoing cardioversion or ablation.~   "
16441|NCT03351764|"~     Background:~      Noninvasive brain stimulation (NIBS) may help diagnose and treat psychiatric and neurological~     illness. But there is not enough research on how to apply NIBS. This includes how strong to~     make it, where on the brain to apply it, and for how long. Researchers also want to see what~     the brain is doing when it receives NIBS.~      Objective:~      To increase the effectiveness of NIBS.~      Eligibility:~      Healthy native English speakers ages 18-65~      Design:~      Participants will be screened under another protocol with:~      Medical and psychiatric history~      Psychiatric evaluation~      Physical exam~      Urine tests~      All participants will start with a 2-hour visit for screening. (see below). They may learn~     how to do tasks that will be used later. After the screening session, they will be scheduled~     for an MRI session.~      The next part of the study is 4 substudies. Each substudy includes up to 4 sessions. A~     session is usually 2-3 hours but can last up to 8 hours. Participants can join multiple~     substudies, but only 1 at a time. They can do only 1 session on a given day.~      Each substudy includes the following:~      Behavioral tests: Interviews; questionnaires; simple tasks; and tests of memory, attention,~     and thinking~      Electromyography: Small sticky electrodes on the skin measure muscle activity.~      Transcranial magnetic stimulation: A wire coil is held to the scalp. A brief electrical~     current passes through the coil and affects brain activity.~      Magnetic resonance imaging (MRI): Participants lie on a table that slides into a machine that~     takes pictures of the brain. A coil is placed over the head. They will perform simple tasks~     while in the scanner. They may also get TMS.~      Electroencephalography: Small electrodes on the scalp record brain waves.~      Sponsoring Institution: National Institute of M~   "
16442|NCT03351751|"~     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of~     multiple repeat oral doses of PF-06372865 in healthy adult subjects.~   "
16443|NCT03351738|"~     A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in~     Adults With Stable Coronary Heart Disease~   "
16444|NCT03351725|"~     Peripheral intravenous cannulas (PIVCs) are utilized in large scale in modern health care.~     Known complications due to a PIVC are phlebitis, thrombosis, bleeding, nerve damage and~     infection. PIVC-related infection causes morbidity, mortality and increased healthcare costs.~     PIVC-related infections can and should be prevented.~      Indwell time is a known risk factor for PIVC-related infection. Another factor potentially~     influencing the risk of developing PIVC-related infection is what type of PIVC that is being~     used. Roughly there are two types of PIVCs. One with an open injection valve and another with~     a closed injection valve. The former being far more used in our hospital and the latter being~     suggested as lowering the risk of PIVC-related infection compared to the open one.~      The investigators aim with this study is to evaluate the incidence of PIVC-colonization in~     300 patients at our 500-bed secondary level hospital in Sweden, as a first step in trying to~     understand what healthcare-providers can improve regarding prevention of PIVC-related~     infections.~   "
16445|NCT03351712|"~     Obesity and overweight are growing steadily and becoming a global epidemic. Recent researches~     report a 64% of the adult population as overweight. The social and economical impact is~     increasing and the most of the rehabilitation programs, while effective in the short term, do~     not produce long lasting results. From a behavioral perspective an explanatory model can~     describe the phenomena with the lack of sources of reinforcement related to healthy habits in~     the daily-life context. The goal of this project, combining Acceptance and Commitment Therapy~     and Wearable Technology, is to develop an effective intervention, efficient and sustainable,~     which continues after ending of the hospitalization, providing adequate contingencies of~     reinforcement in the natural environment, integrating systematic measurements, continuous~     feedbacks and individualized, values-based objectives. Related goal-setting show a shift from~     results linked with weight loss towards action connected with healthy life-style.~   "
16446|NCT03351699|"~     The study will evaluate the safety, tolerability, pharmacokinetics, and anti-retroviral~     activity of MK-4250 monotherapy in anti-retroviral therapy (ART)-naïve, HIV-1 infected~     participants. The primary hypothesis of the study is that at a dose that is sufficiently safe~     and generally well tolerated, MK-4250 has superior antiretroviral activity compared to a~     historical placebo, as measured by change from baseline in plasma HIV-1 ribonucleic acid~     (RNA) (log10 copies/mL) at 168 hours postdose.~   "
16447|NCT03351686|"~     postpartum hemorrhage (PPT) represents one of the major causes of maternal mortality .~     Tranexamic acid is used in many studies in management of PPH in combination with ecobolics.~     this study aims to evaluate the possible value of the use of tranexamic acid in prevention of~     postpartum hemorrhage .~   "
16448|NCT03351673|"~     Endometrial thickness has been used as an indicator of risk for endometrial hyperplasia and~     carcinoma in asymptomatic perimenopausal women. However, there is no cutoff value in~     perimenopausal women and the same thickness does not express the same endometrial volume in~     different endometrium because uterine lengths may be different and endometrial irregularities~     may exist. Many studies assessed endometrial volume measured by three-dimensional (3D) TVS as~     a predictor of malignancy in women with postmenopausal bleeding. To our knowledge there is no~     study assess endometrial volume measured by two dimension TVS in prediction of endometrial~     pathology, however it is cheap and available than 3D TVS.~   "
16449|NCT03351660|"~     Heart disease symptoms are a frequent reason of consultation in general medical practice.~     Only a few general practitioners are equipped with a 12 lead Electrocardiography (ECG)~     whereas this test is extremely useful for diagnosis orientation in cases of cardiac~     diseases.Cardiosecur allows the realization of a 15 or 22 leads ECG with only 4 electrodes~     connected to a smartphone or a tablet with an automatic interpretation function. The goal of~     the study is to evaluate the diagnostic value of Cardiosecur device regarding cardiac~     symptoms in family practice.~   "
16462|NCT03351491|"~     This study evaluates the frequency of use of smartphone health applications among people~     consulting in primary care in the Grenoble region, France.~      This is a descriptive study using a questionnaire completed by the patient and distributed by~     general practitioners. The study also collects the type of used application as well as the~     rhythm of usage, and compares the use of mobile health applications according to the~     sociodemographic, geographical and medical characteristics of the studied population.~   "
23635|NCT03257605|"~     The aim of this study is to evaluate and describe the feasibility of implementing a~     pharmacist-led pharmacogenomics service for the Program of All-inclusive Care for the Elderly~     (PACE), a community-based practice setting.~   "
16450|NCT03351647|"~     Ustekinumab is a fully human Immune Globulin Gk (IgGk) monoclonal antibody against the common~     p40 subunit of interleukin-12 and interleukin-23, which are implicated in the pathogenesis of~     inflammatory bowel disease. Its efficiency to induce and maintain clinical response in~     patients with anti TNF resistant Crohn's disease has been proved in several clinical trials,~     and the profile of safety of this treatment was good, but the investigators have few data~     about biological characteristics of patients treated by Ustekinumab, particularly about~     ustekinumab through levels and rate of patients developing anti ustekinumab antibodies during~     the induction and maintenance stages, and no predictive factors of clinical response have~     been identified yet.~      The aim of this study will be to assess the evolution of biological markers of inflammation~     and ustekinumab trough levels and antibodies, in responders and non responders patients~     treated by ustekinumab, in order to identify predictive factors of clinical response.~      The investigators will perform a prospective observational study, including the patients~     followed in the University hospital center of Lyon and treated by ustekinumab for a moderate~     to severe Crohn's disease (with a HBI score≥4 ). All the patients included will have been~     previously treated by at least one anti TNF and/or Vedolizumab, with specified criteria for a~     primary non response, a secondary loss of response or unacceptable side effects.~      Then, clinical and biological data will be collected for each patient at the inclusion, and~     then at weeks 4, 8, 16, 24: HBI score, sides effects, extra intestinal manifestations,~     steroids withdraw, CRP, calprotectin, ustekinumab trough levels and ustekinumab antibodies.~      The investigators will compare responding and non responding patients at week 16 (end of the~     induction period) according to these data.~      The hypothesis the investigators state is that an early and significant decrease of the~     inflammation markers in blood and stools associated with a high ustekinumab through level in~     blood is associated with a clinical response at week 16 in the patients treated by~     ustekinumab~   "
16451|NCT03351634|"~     Urinary continence is still a difficult goal to achieve in neurogenic bladder patients.~     Conservative treatment of neurogenic urinary incontinence using clean intermittent~     catheterization in conjunction with pharmacological therapy, notably anticholinergic~     medication +/- adrenergic agents, may produce continence in a variable number of patients. In~     other patients, reconstructive surgery of the bladder and/or bladder neck is necessary to~     achieve urinary continence. Surgical treatment options to increase bladder outlet resistance~     in patients with neurogenic bladder include injection of bulking agents around the bladder~     neck, bladder neck reconstruction, fascial sling procedures and Artificial Urinary Sphincter.~      The Adjustable Continence Therapy system (ACT) or periurethral adjustable balloons are a~     minimally invasive device consisting of two volume-adjustable balloons implanted~     periurethrally at the bladder neck as a method of augmenting titration for urethral~     coaptation. Adjustable means that such system would be adaptable to the individual clinical~     condition.~      Originally conceived and developed as a treatment for female stress urinary incontinence, the~     technique has been then adapted and balloons were globally developed for the use in~     postprostatectomy incontinence. The published success rate in male after prostatectomy and in~     women was respectively 56 to 92% and 60 to 83%.~      The investigators hypothesize that the use of ACT for treating incontinence in children~     secondary to neurogenic sphincter incontinence could compress the urethra or the bladder~     neck, acting as an extrinsic occlusive system increasing passive and dynamic urethral and~     bladder resistance.~      Goal of the study:~      To prospectively assess the efficacy and safety of periurethral adjustable balloons in the~     treatment of neurogenic incontinence in children with spinal dysraphism.~      Material and methods :~      A prospective study will be performed at La Timone Enfants hospital and La Nord hospital in~     Marseille, France. Boys and girls at least at school age (5 or 6 years) with neurogenic~     incontinence due to outlet issues (low detrusor leak point pressure and low stress leak point~     pressure) with spinal dysraphism will be recruited.~      The ACT balloon is an implantable medical device developed and furnished for free by~     Uromedica (Irvine, CA, USA). The procedure is performed under general anaesthesia using the~     same implantation technique as published in adult population.~   "
16452|NCT03351621|"~     Nutritional status depletion is associated with complications such as increased morbidity and~     mortality, worsening of patients' quality of life and increased length of hospital stay.~     Thus, nutritional therapy defined as the set of therapeutic procedures for maintenance or~     recovery of the nutritional status of the patient, becomes a procedure of extreme importance~     in the hospital setting. It should be carried out by an interprofessional team, in order to~     ensure adequate patient care. Aim: This study intends to evaluate the reality of Nutritional~     Therapy in Brazil, 18 and 14 years after the introduction of the resolution n ° 272 and the~     RDC n ° 63, respectively, regarding the practice of this important therapy and the existence~     of interdisciplinary teams. Method: Descriptive, observational and national study. In each~     Brazilian state was selected the capital, and drawn a city of average and other one of small~     size. Next, a public, private and university hospital in each municipality was randomly~     selected. Data collection will be done by means of a questionnaire, based on the Secretary of~     Sanitary Surveillance of the Ministry of Health resolution n ° 272 and the RDC n ° 63. The~     questionnaire will be applied by the researchers, and directed to the health professionals~     involved in the Nutritional Therapy practice in each of the selected hospitals.~   "
16453|NCT03351608|"~     This trial will evaluate the efficacy, safety, and pharmacokinetics of sugammadex for the~     reversal of both moderate and deep neuromuscular blockade (NMB) induced by either rocuronium~     or vecuronium in pediatric participants. The primary efficacy hypothesis of this~     investigation is that sugammadex is superior to neostigmine in reversing moderate NMB in~     pediatric participants as measured by time to recovery to a train-of-four (TOF) ratio of~     ≥0.9.~   "
16454|NCT03351595|"~     Ongoing longitudinal birth cohort established at Mok-dong Hospital, Ewha Woman's University,~     Seoul, South Korea, between 2001 and 2006.~   "
16455|NCT03351582|"~     The overall purpose of this project is to evaluate the effects of a family therapy~     intervention for grieving families with children. The main outcome variable is family~     communication.~   "
16456|NCT03351569|"~     Single patient randomized double blind trial to assess whether intravenous immunoglobulin can~     improve the clinical outcome of a case suffering from Unverricht-Lundborg disease.~   "
16457|NCT03351556|"~     1. Determine the dose-response relationship between a cash transfer amount and HIV viral~          suppression at 6 months~        2. Identify the most effective cash transfer size to increase the proportion of people~          living with HIV infection (PLHIV) retained in care and with suppressed viral load (<1000~          copies/ml) after 6 months. (This amount will be further evaluated in a cluster~          randomized trial in Phase 2).~   "
16458|NCT03351543|"~     The effect of microbial exposure on healthy human subjects will be investigated. Changes in~     cytokine and IgE and vaccine response will be measured. The hypothesis is that microbial~     exposure increases the measured responses.~   "
16459|NCT03351530|"~     More than ninety percent of adults in Taiwan are suspected to carry periodontal disease,~     which causes bad breath, swollen and bleeding gums, plaque and even tooth loss. Half of the~     patients, however, are ignorance these clinical syndromes because of no obvious pain. A lot~     of researches show that periodontal disease is related to diabetes mellitus. Periodontal~     disease causes rise of blood sugar, and more than 3 times as diabetes mellitus patients as~     healthy people have serious periodontal disease.In this study, the investigators collect~     periodontal pocket and saliva samples of participants, and selecting six periodontal~     disease-associated bacteria strains, including Porphyromonas gingivalis (Pg), Fusobacterium~     nucleatum (Fn), Actinobacillus actinomycetemcomitans (Aa), Treponema denticola (Td),~     Prevotella intermedia (Pi) and Tannerella forsythia (Tf) as diagnostic markers. Participants~     will get bacteriostasis mouthwash at mouth 2. The investigators will compare the differences~     of blood biochemistry value and oral bacteria strains after using the mouthwash.Using~     real-time PCR and MALDI Biotyper, the investigators will establish the database of oral~     microorganisms in diabetes mellitus patients, providing periodontal disease clinical markers~     of high-risk groups and the basis for personal medicine of therapy in the future.~   "
16463|NCT03351478|"~     Primary Objective:~      To demonstrate the superiority of sotagliflozin versus placebo on hemoglobin A1c (HbA1c)~     reduction in patients with type 2 diabetes (T2D) who have inadequate glycemic control on a~     Dipeptidyl Peptidase 4 Inhibitor (DPP4(i)) with or without metformin.~      Secondary Objectives:~        -  To demonstrate non-inferiority of sotagliflozin versus empagliflozin on HbA1c reduction.~        -  To demonstrate the superiority of sotagliflozin versus placebo on 2-hour postprandial~          glucose (PPG) reduction, fasting plasma glucose (FPG) reduction, body weight reduction,~          on the proportion of patients with HbA1c <6.5% and <7.0%, and on sitting systolic blood~          pressure (SBP) reduction.~        -  To demonstrate the superiority of sotagliflozin versus empagliflozin on HbA1c reduction~          and sitting SBP reduction.~        -  To evaluate the safety of sotagliflozin versus empagliflozin, and placebo, throughout~          the trial.~   "
16464|NCT03351465|"~     Anxiety and depression is common along pregnant mothers and has been found to increase risk~     for negative outcomes in both mothers and infants. These risks can include low infant birth~     weight, negative mother-infant interactions, and delayed developmental outcomes.~     Evidenced-based interventions to support pregnant women experiencing symptoms of depression~     or anxiety are not well studied or widely available, particularly for low-income women of~     color. These women may not have access to the type of healthcare that would best support~     their needs and/or they may not be familiar with or trust clinicians who deliver mental~     health interventions. The current randomized-controlled trial (RCT) aims to address these~     gaps in the literature by testing the feasibility and efficacy of a doula-supported,~     computer-assisted delivery of a cognitive behavioral therapy (CBT) intervention designed to~     reduce pregnancy-related anxiety, depression, and prevent perinatal mood disorders. The 120~     participants in the study (60 Black women and 60 Hispanic/Latina women) will be randomized to~     either receive the Coordinated Anxiety Learning and Management (CALM) intervention (n=60) or~     treatment as usual (n=60). Participants assigned to the intervention will complete 6-8~     sessions of CALM with a language and ethnically/racially-matched doula who has been trained~     as a CALM specialist in order to increase participant comfort and reduce the stigma~     associated with mental health services. Women in both groups will complete assessments of~     their pregnancy-related anxiety, general anxiety, depressive symptoms, and satisfaction with~     treatment (CALM or treatment as usual) at baseline, 12-weeks post-baseline, and 10-weeks~     post-birth. It is hypothesized that women assigned to the CALM intervention will have~     significantly less anxiety and depressive symptoms post-treatment and post-partum compared to~     the women assigned to treatment as usual. The results of the current RCT will be used to test~     the efficacy of the CALM intervention for pregnant women or color and to inform efforts for~     potential future scalability.~   "
16465|NCT03351452|"~     Previous studies showed that transcranial electric stimulation (tES) applied over the~     prefrontal cortex improves cognitive performance in healthy elderly adults as well as in~     patients suffering from mild cognitive impairment or early Alzheimer's disease. Therefore,~     tES methods might be a useful intervention tool for patients suffering from memory impairment~     in early terms of the disease.~      The present study aims at establishing a connection between the stimulation-induced changes~     on associative memory performance and its underlying neurophysiological parameters. tES~     effects and their underlying mechanisms will be compared between healthy elderly controls and~     clinical study populations receiving either real or sham tES over the left ventrolateral~     prefrontal cortex during an associative memory task.~   "
16466|NCT03351439|"~     The purpose of the full study is to determine whether multimodal analgesia for hip~     arthroscopy will reduce post-operative pain scores, narcotic consumption and hospital~     length-of-stay. To do this, the investigators will compare the standard of care (SOC), with~     routine pain management with a post-operative opioid prescription, to three different groups~     with multi-modal analgesia (SOC+peri-operative celecoxib, SOC+peri-operative gabapentin, and~     SOC+post-operative zopiclone).~      The investigators hypothesize that administration of multi-modal analgesia in all three~     treatment groups will result in improved post-operative pain control, reduced post-operative~     narcotic consumption and an overall reduction in post-operative length-of-stay compared to~     the group receiving treatment as per the standard of care. However, prior to undertaking a~     large multi-centre study, the investigators need to determine whether the study is feasible~     from data obtained with this pilot study.~   "
16467|NCT03351426|"~     The purpose of this study is to examine the effects of noninvasive neuromodulation with~     transcranial direct current stimulation (tDCS) aimed at enhancing the excitability of the~     left prefrontal cortex in middle-aged women with excess body weight. This is a randomized,~     parallel, double-blind study with a duration of 4 weeks. Outcome measures will include~     changes in performance in a computerized task assessing executive functions, subjective~     measures of food craving and appetite and changes in body weight.~   "
16468|NCT03351413|"~     Purpose: To test the effect of LIVE-LiFE, a home-based, tailored fall prevention program for~     older adults with a high risk for falling.~      Study Type: Single-blind, two group randomized pilot trial. Randomization is 2:1 (27~     intervention, 13 control). Participants have a chance of being in the LIVE-LiFE group or the~     control group.~      Safe-LiFE Group: Individually tailored intervention at the participant's home spaced across~     12 weeks including:~        -  Home safety assessment and risk reduction strategies; incorporating strength and balance~          training into daily habits vision screening and referral; and education about fear of~          falling and falls~        -  Home repairs, modifications, and low cost assistive devices to address unsafe home~          environments increasing fall risk~        -  Medication review and feedback concerning medications with increased fall risk~      Control Group:~      • An individualized fall risk assessment provided to participant and their primary care~     provider~      Sample: 40 community-dwelling older adults in Baltimore City or County~   "
16469|NCT03351400|"~     The purpose of this study is to determine the safety and effectiveness of intracoronary~     infusion of autologous cardiac stem cells in patients with ischemic cardiomyopathy.~   "
16470|NCT03351387|"~     Researchers are performing this study to evaluate if intraoperative angiography can be shown~     numerically to determine which wounds are at high risk of wound necrosis/breakdown.~   "
16471|NCT03351374|"~     Under this Small Business Innovation Research (SBIR) Phase II project, Research Topic 155,~     the Contractor will create an integrated multi-module system of web software tools to aid in~     behavioral health screening, prevention, triage, and tracking in medical, school, and mental~     health settings.~   "
16485|NCT03351179|"~     This retrospective observation is to investigate the incidence,clinical outcomes and~     prognosis of hospitalized heart failure with preserved ejection fraction (HFpEF) in patients~     with acute myocardial infarction(AMI).~   "
16486|NCT03351166|"~     The purpose of this study is to evaluate the efficacy and safety of Molidustat in dialysis~     subjects with renal anemia who are not treated with Erythropoiesis-Stimulating Agents (ESAs)~   "
16487|NCT03351153|"~     To verify that CT scan and X-ray can predict the collapse of the necrotic femoral head before~     hip arthroplasty and effectively guide the surgical management.~   "
23648|NCT03257436|"~     Prospective, multi-center, single arm, post approval study to be conducted in the United~     States.~   "
16472|NCT03351361|"~     Lung cancer is the most common cancer in the world and the leading cause of cancer-related~     deaths in Western countries. Unfortunately, at the time of diagnosis, the majority of~     patients already have metastatic disease and a systemic, palliative treatment is the primary~     therapeutic option.~      Guidelines for PS 2 patients or older than 75 years old patients at the time of diagnosis~     recommend for fit patients a carboplatin doublet chemotherapy.~      Nivolumab has proven efficacy in 3rd line squamous cell lung carcinoma and is superior to~     chemotherapy in 2nd line treatment of squamous and non-squamous lung cancer in term of~     overall survival.~      In 1st line, nivolumab failed to show superiority compared to a platin based doublet in terms~     of progression free survival and overall survival in tumors ≥ 5% PD-L1 expression. The~     association Nivolumab plus Ipilimumab showed encouraging results in first line setting in~     phase 1 study.~      The investigators think that with regard to the manageable toxicity of nivolumab in lung~     cancer population and the possibility to obtain long responses, this association could be a~     valid option for this population of elderly and/or PS2 patients in term of overall survival.~   "
16473|NCT03351348|"~     The purpose of this study is to compare using bupivacaine (a numbing medicine) along with the~     usual medications for post-operative pain control to using the usual medications for~     post-operative pain control alone. The addition of bupivacaine to the usual pain medications~     could better manage pain immediately after surgery. This study will allow the researchers to~     know whether this different approach is better, the same, or worse than the usual approach.~   "
16474|NCT03351335|"~     To evaluate the Ulthera® System for lifting submental (under the chin) and neck tissue in~     Chinese patients~   "
16475|NCT03351322|"~     The objective of this study is to evaluate the efficacy and safety of ENERGI-F701 Solution in~     female subjects with hair loss.~   "
16476|NCT03351309|"~     The study team propose to investigate the feasibility and pilot a Telephone Cognitive~     Behavioral Therapy intervention for those identified to be at risk for chronic pain following~     surgery.~   "
16477|NCT03351296|"~     Compare the effect of capecitabine (cape) + temozolomide (temo) and of 5FU + streptozotocin~     (strepto) given with a new schedule (LV5FU2 + strepto), two of the most used chemotherapy~     regimens in the treatment of well differentiated pancreatic neuroendocrine tumors alone or in~     combination with bevacizumab (beva) on progression-free survival (PFS) and compare the~     chemotherapy regimens alone or with beva (two by two design) on the same criteria.~   "
16478|NCT03351283|"~     The SODA-HF trial is a randomized, double-blind, controlled trial to evaluate the effect of~     moderate to severe sodium restriction on brain natriuretic peptide in patients with heart~     failure and reduced ejection fraction (less than 40%).~      Secondary outcomes are quality of life, NYHA functional class, glomerular filtration rate,~     renin plasmatic activity, aldosterone and composite clinical outcome (all-cause mortality and~     cardiovascular hospitalization)~   "
16479|NCT03351270|"~     This is the 2 years extension of the European part of the prospective and longitudinal study~     of the natural history and function of patients with myotubular myopathy (MTM) initially~     sponsored by Valerion therapeutics. Twenty additional patients with other centronuclear~     myopathies (CNM) (due to mutation in MTM1 but also in DNM2 or BIN1 genes) are planned to be~     enrolled in one year leading to an expected total number of 60 patients followed at least~     over 1 year period. Data from the study will be used to characterize the disease course of~     CNM and determine which outcome measures will be the best to assess the efficacy of potential~     therapies.~   "
16480|NCT03351257|"~     Colorectal cancer is a maior cause of morbidity and mortality worldwide.Colonoscopy and~     removal of all adenomas is the most efficient method to prevent colorectal cancer.The most~     colorectal polyps detected are small(<10mm) and diminutive(≦5mm) during colonoscopy.At that~     size,the are overwhelmingly hyperplastic or adenomatous,and rarely harbour high-grade~     dysplasia,cancer or sessile serrated adenoma/polyp.Traditional white-light endoscopy cannot~     reliably distinguish between small adenomatous and hyperplastic polyps,thus,real-time~     recognition of the polyp histology during colonoscopy has the potential to minimize both the~     costs and complications associated with endoscopic biopsy and polpectomy.Linked color~     imaging(LCI),a new system for endoscopy modality,creates clear and bright endoscopic images~     by using short-wavelength narrow-band laser light combined with white laser light on the~     basis of magnifying blue laser imaging(BLI) technology. it is easier to recognize a slight~     difference in color of the mucosa. This is a study to investigate the impact of Linked color~     imaging endoscopes on the in vivo histology prediction of colonic polyps.~   "
16481|NCT03351244|"~     The objective of the study is to investigate the efficacy, safety and tolerability of BI~     409306 once daily compared with placebo given for 28 weeks in patients with schizophrenia on~     antipsychotic treatment. The study is designed to show superiority of BI 409306 over placebo~     in preventing relapse of schizophrenia symptoms.~   "
16482|NCT03351231|"~     The purpose of this study is to investigate safety of experimental medication BMS-986242 and~     Nivolumab in patients with advanced cancers.~   "
16483|NCT03351218|"~     In this study, using computerized cognitive assessments combined with multi-modal~     neuroimaging approach investigators aim to address three specific questions on patients with~     cervical and myoclonus dystonia:~      (i) investigate various aspects of the sense of agency and relationship to the severity of~     dystonia symptoms, (ii) characterize the possible link between abnormalities of movement~     perception and alteration of sense of agency in dystonia, (iii) (identify the neuronal~     underpinnings of the defective sense of agency in dystonia.~   "
16484|NCT03351205|"~     Asherman's syndrome is characterized by the presence of intrauterine adhesions (IUA) as well~     as symptoms such as amenorrhea, hypomenorrhea, pelvic pain, and infertility. The gold~     standard for the treatment of intrauterine adhesions is hysteroscopic intrauterine adhesions.~     The recurrence of intrauterine adhesions is a major challenge in clinical practice.~     Intrauterine balloon has been used for the prevention of intrauterine adhesions. It has been~     reported that dried biological amnion graft was used to prevent adhesion after the operation~     of intrauterine adhesions. Estrogen is also used for postoperative prevention of intrauterine~     adhesions. Intrauterine balloon can reduce the recurrence of adhesions after operation.~     Disposable balloon uterine stent，which is an innovative intrauterine balloon，is specially~     designed to fit into the cavity of the uterus. Does Disposable balloon uterine stent and~     amniotic products combine estrogen therapy improve clinical outcomes? Therefore, this study~     was conducted.~   "
16488|NCT03351140|"~     The objective of this study is to conduct in-person qualitative interviews of subjects who~     have different tumor types to identify and assess relevant PROMIS physical function items~     that can be utilized in future studies. Health Research Associates (HRA) will conduct~     qualitative interviews in subjects with a variety of cancer types. PROMIS is a set of~     self‐report measurement tools, developed by the United States (US) National Institutes for~     Health (NIH). The most recent version of PROMIS Physical Function Item Bank contains 165~     items assessing a range of abilities and its subset, a 45-item PROMIS Function Cancer Item~     Bank which contains questions relevant to subjects with cancer. Approximately 150 subjects~     with five tumor types will be recruited. HRA will conduct the interviews that will be~     audio-recorded for transcription and analysis. Five tumor types that will be focused on are~     Breast, Prostate, Non‐Small‐Cell Lung Cancer (NSCLC), Multiple Myeloma, and Diffuse Large~     B‐Cell (DLBCL) or Follicular Lymphoma. Interviews will be conducted in English language in~     private areas within clinic site or rented meeting facilities and will last approximately for~     60-90 minutes.~   "
16489|NCT03351127|"~     To establish the range of BS and ES (m/s) of normal carotid artery by using ultrafast pulse~     wave velocity (UFPWV), and to explore the influencing factors.~   "
16490|NCT03351114|"~     This is a pilot study to determine the safety and clinical efficacy of crisaborole 2%~     ointment in the treatment of morphea.~   "
16491|NCT03351101|"~     Evaluation of Johnson & Johnson Acuvue Vita (senofilcon C) soft contact lenses to the Bausch~     + Lomb Ultra (samfilcon A) soft contact lenses~   "
16492|NCT03351088|"~     Since its introduction, robot-assisted radical prostatectomy (RARP) have become the standard~     surgical approach for the treatment of prostate cancer in the United States and then in~     Europe. Continuous refinements of surgical technique has been described in order to maximise~     outcomes while minimizing morbidities.~      The management of DVC is a crucial steps during RARP. It could be done prior or after its~     transection thanks to haemostatic effects of the pneumoperitoneum. This topic has been~     already investigated by some authors. However, no high quality evidence is available to opt~     in favour of either of the two approaches. Findings about estimated blood loss, positive~     surgical margins and urinary recovery differ among these studies and only one is a randomized~     controlled trial in a laparoscopic setting with a limited number of patients.~      Therefore, our objective was to evaluate in a prospective randomised setting whether a~     delayed ligation of the dorsal vascular complex impacted on perioperative, functional and~     oncological outcomes as compared to preventive ligation during robot-assisted radical~     prostatectomy.~   "
16493|NCT03351075|"~     In addition to fatigue, pain is the most frequent and persistent symptom following breast~     cancer and breast cancer treatment. Despite the effectiveness of different physical therapy~     modalities, such as manual techniques, passive mobilizations and exercises, many patients~     still experience pain and subsequent difficulties in daily functioning at short and long~     term. Past decades, the awareness on the important role of educational interventions in the~     management of pain in general has increased. Educational interventions aim at explaining and~     improving the knowledge, control and attitude of the patient regarding his/her pain~     complaint. However, these educational interventions are often restricted to more biomedical~     pain management instructions and general advice on physical activity and analgesics (=~     traditional biomedical education). Only recently, increased knowledge on pain mechanisms led~     to a more modern educational approach. This modern approach is suited to explain more complex~     issues associated with pain and takes into account many more factors related to pain. To our~     knowledge, only one controlled trial investigated the effectiveness of a modern educational~     intervention in the early stage of breast cancer treatment. The results were very promising~     for shoulder function. However, only short-term effects were examined, no randomization was~     performed and no pain-related and socio-economic outcomes were evaluated. Therefore, the aim~     of the proposed project is to investigate the effectiveness of a similar modern educational~     program, in addition to standard physical therapy care, in the early treatment phase of~     breast cancer in comparison with traditional biomedical education. A randomized controlled~     trial will be performed with a long-term follow up period. The primary outcome parameter is~     pain-related disability. Secondary outcomes are different dimensions of pain, physical and~     mental functioning, return to work and health-care related costs.~   "
16494|NCT03351062|"~     This clinical trial is designed to be a multi-center prospective, parallel-controlled Phase~     III clinical study. In this study, the efficacy of tamoxifen versus toremifene shall be~     compared in CYP2D6 intermediate/poor metabolizers of premenopausal patients with estrogen~     receptor-positive early breast cancer.~   "
16495|NCT03351049|"~     Pressure injuries are a serious health care problem and affect millions of people. Most~     pressure injuries are avoidable with the application of best practices and with the use of~     appropriate technology. Support surfaces are a crucial component of any comprehensive~     prevention strategy. Decades of research have produced moderate and low levels of evidence~     upon which to base clinical decisions concerning how and when to apply support surfaces for~     prevention. This knowledge has been periodically assessed and assembled into clinical~     practice guidelines. There is good evidence that the combined group of active and reactive~     support surfaces is effective in preventing pressure injuries and that high-specification~     reactive foam surfaces are effective in preventing pressure injuries. But there is~     insufficient evidence that low air loss surfaces are more or less effective than other types~     of surfaces. Yet, low air loss surfaces are used for more than 17% of patients in acute care~     at high risk of developing pressure injuries.~      The study is designed to determine if and when low air loss is effective in preventing~     pressure injuries, and what level of heat and moisture control performance is necessary for~     prevention effectiveness. The primary aim of the project is to compare the effectiveness of~     reactive support surfaces with low air loss to reactive support surfaces without low air loss~     in preventing pressure injuries for people with moisture risk factors in acute care. Support~     surfaces are currently marketed and identified by practitioners based on device features~     (e.g., low air loss, air fluidization, alternating pressure), categories (powered,~     non-powered, reactive, and active) and components (e.g., foam, gel, fluid).~      The critical performance characteristics of low air loss systems are moisture, humidity and~     temperature management. Preliminary work has revealed that these characteristics vary widely~     among different low air loss products. A secondary aim of the proposed study is to explore~     associations between support surface performance characteristics and pressure injury outcomes~     to identify which low air loss performance characteristics and what level of those~     performance characteristics are necessary for the technology to be effective.~      Successful completion of this project will fill a critical gap in evidence regarding the~     effectiveness of support surfaces with low air loss, and could influence a shift in the way~     support surfaces are characterized away from the current feature-based paradigm toward a more~     clinically relevant and generalizable performance-based paradigm.~   "
16496|NCT03351036|"~     Perioperative hypothermia is a common problem in today´s surgical and anesthesiological~     patient care and is associated with many adverse events. The intention of this study was to~     evaluate the current S3 guideline on the avoidance of perioperative hypothermia concerning~     it´s implementation in the clinical routine.~   "
16497|NCT03351023|"~     To prospectively examine the relations between adherence scores for three healthful dietary~     patterns, the Alternate Mediterranean diet (AMED), the Dietary Approaches to Stop~     Hypertension (DASH), and the Alternative Healthy Eating Index (AHEI-2010), and risk of~     hearing loss in the Nurses' Health Study II.~   "
16498|NCT03351010|"~     Using pharmacologic agents are often effective to treat patients with cancer pain, but there~     are associated with serious side-effects and risks of dependence and addiction. The Thai~     Buddhism-based Mindfulness (TBbM) intervention created by a widely respected Buddhist monk~     focuses on testing a meditation technique to manage pain. If effective, millions of patients~     who suffer with cancer pain will benefit from use of a safe, culturally appropriate,~     non-pharmacologic approach to pain management.~   "
16499|NCT03350997|"~     The study team will assess free-living 24h glucose control using continuous glucose~     monitors (CGM) over an 88h period on two separate occasions. Importantly, standardized meals~     will be provided and will be consumed at specific times each day of the CGM measurement~     period. These meals will be identical on day 1 and day 3 of measurement. Each subject will~     complete two CGM periods, which will be identical except for the calorie and macronutrient~     content of the post-exercise dinner. In addition, during trial 1, two CGM's will be worn,~     while only 1 CGM will be worn on trial 2.~   "
16500|NCT03350984|"~     The aim of the study is to determine differences in glycemic control between a traditional~     regimen with Neutral Protamine Hagedorn insulin (NPH) and a physiological regimen or basal~     bolus regimen with glargine and lispro insulin in a population of hospitalized patients with~     type 2 diabetes in a Noncritical Care Facility. Patients with a recent diagnosis of type 2~     and patients on treatment with oral hypoglycaemic agents and insulin or only insulin were~     included.~      The primary outcome of the study is to determine difference in efficacy and security between~     the treatment groups as measured by the mean daily blood glucose (efficacy is normoglycemia~     and number of days in glycemic control during the hospital stay; security is hypoglycemic~     events and complication diabetes mellitus associated).~   "
16501|NCT03350971|"~     Coronary artery disease is a dysfunction characterized by the narrowing of the coronary~     arteries in due to the accumulation of atheromatous plaques. The surgery of myocardial~     revascularization is a surgical procedure of choice performed in individuals with to improve~     symptoms and survival. Cardiovascular surgeries of this size in an extended time of rest~     after the procedure. Such immobility may have repercussions to the functionality of the~     individual. Thus, the early mobilization with the use of reality in the Intensive Care Units~     (ICU) emerges as a potential means of of complications in the postoperative period of cardiac~     surgery.~   "
16502|NCT03350958|"~     Obesity is a wide reaching problem in the United Kingdom (UK). The most widely used obesity~     therapies are based around drugs that reduce dietary fat digestion, and thereby reduce uptake~     of calories from the diet. While such therapies have proved effective, patient compliance is~     low due to the unwanted gastrointestinal side effects of these drugs. Dietary fibre is~     generally classified as dietary material of plant origin that is indigestible to humans.~     Dietary fibre is in fact a wide range of different compounds that have varied effects on the~     human body. Initial findings from our laboratory suggest that types of fibre from seaweeds~     (alginates) can greatly reduce the rate that fat is digested in the laboratory. Our studies~     have identified which types of fibre are the most effective and our aim is to test whether~     this reduction in fat digestion is the same within the human body. This will be carried out~     by sampling the digestive fluid from 40 ileostomy patients over a five hour period following~     a test meal with and without dietary fibres. All study participants will be provided with~     test foods specially prepared containing the dietary fibres (e.g. in bread). We will collect~     data from the participants on what they have eaten and how hungry they feel.~   "
16503|NCT03350945|"~     The project aims to evaluate the safety, effectiveness, accuracy and economy efficiency of~     the application of carbon nanoparticles for tumor localization and lymph nodes mapping in the~     laparoscopic coloectal surgery.~   "
16504|NCT03350932|"~     The objective of this intervention is to evaluate the effect of sensory imagination (i.e.,~     imagining the sensory properties of an object) on the choice of food portion size in~     school-aged children. Previous research showed that it may help children to choose smaller~     portion size. The investigators would like to assess whether this effect can be reproduced~     with two types of food (one with a high energy-density and one with a low energy-density),~     and in older children.~   "
16505|NCT03350919|"~     The purpose of this research is to assess the efficacy of a visual training task on reducing~     the size of a visual field deficit caused by brain damage in adults, and its ability to~     improve visual functions in this patient population.~   "
16506|NCT03350906|"~     Researchers are trying to understand how chronic inflammation affects muscle function and~     responses to exercise.They are also trying to determine if suppressing chronic inflammation~     using omega-3 fatty acids (n3-PUFA) restores skeletal muscle function and exercise~     responsiveness in older adults.~   "
16507|NCT03350893|"~     Previous studies on skin health with Lactic acid bacteria (LAB) have been published for many~     years, including prevention of skin diseases and improvement of skin conditions. In this~     clinical study, the investigators researched the benefit effects of heat-killed Lactobacillus~     plantarum cream on skin health.~   "
16508|NCT03350880|"~     Comparison of therapeutic intervention to gain range of motion at the hip joint within~     therapeutic in water and on land. Stretching is a therapeutic maneuver used to increase the~     length of shortened soft tissue structures and thereby gain range of motion; for that,~     innumerable procedures within Physiotherapy use it for the benefit of patients. The work in~     question is justified by the need to seek the means that can promote a better performance in~     the application of the stretching procedure, called Proprioceptive Neuromuscular~     Facilitation, in a universe of pre-selected volunteers. It is a relevant and feasible study,~     hoping that its results may benefit future patients, with better results and faster~     responses. What is the medium that leads to better results in a program using the~     proprioceptive neuromuscular facilitation technique? Hypotheses: a - Probably the heated~     aquatic environment, in a range of 32 ° to 36 ° C, will promote a better result, since the~     heat increases the collagen's distensibility. b - Perhaps the heat, by increasing the~     excitability threshold of nerve fibers, triggers the protective reflex later, which may~     promote a more vigorous elongation without the protective response. c - Possibly the~     relaxation promoted in the aquatic environment, could influence the gains obtained in the~     swimming pool.~   "
16548|NCT03350360|"~     Participants will complete a pre and post training psychological assessment. Participants~     will be assigned to attention control training or the comparison stimuli computer task in a~     double-blind randomized control trial design. Both computerized dot probe tasks display two~     stimuli on a computer screen, one above the other, followed by a small right or left arrow~     appearing in the location vacated by one of the stimuli. Participants are required to respond~     as quickly as they can by pressing the indicated right or left arrow on their computer~     keyboard without compromising accuracy. Participants complete 6 training sessions.~   "
16549|NCT03350347|"~     The purpose of this study is to evaluate the efficacy and safety of molidustat in~     non-dialysis subjects previously treated with Erythropoiesis-Stimulating Agents (ESAs)~   "
16509|NCT03350867|"~     INTRODUCTION: Custom insoles with anterior or posterior support are described in the~     literature mainly for the treatment of foot and knee dysfunctions and this therapeutic effect~     extends to the promotion of biomechanical alignment between pelvis and trunk, by an ascending~     propceptive response. In this perspective, it can be hypothesized that the use of these~     insoles may favor individuals with anterior and posterior cross pelvis syndrome, who have~     biomechanical imbalance in the pelvis segment. To date, there is no literature data on the~     effect of continuous, noninvasive and inexpensive therapy on this individual profile.~      OBJECTIVE: To evaluate the effects of using customized insoles with anterior or posterior~     plantar support in cross pelvis syndrome and in perception of body alignment in young adults.~      METHODS: This is a blinded randomized controlled trial in individuals of both sexes aged~     18-25 years and functionally diagnosed with posterior or anterior pelvic syndrome. Excluding~     thoracic deformities, lower limb differences, diabetic neuropathy, previous reports of some~     specific surgeries and treatment of ongoing physiotherapy. A pilot study will be carried out~     with 20 individuals divided into two groups for sample calculation (Personalized Insole Group~     and Placebo Group). After the pilot study, an initial screening will be carried out to verify~     the eligibility criteria. For the eligible, the pre-intervention evaluation will be carried~     out, which will be contemplated by personal data; scale of presence and intensity of pain;~     foot health status; foot posture index; by ely and thomas hamstring tests associated with an~     inclinometer and by photogrammetry. Individuals will be randomized into blocks of 10~     individuals. A day will be marked to make the insole, in which the researcher will make the~     adaptations based on the biomechanical evaluation of the volunteer. To the invidious with the~     posterior cross pelvis syndrome an anterior support will be made in the insole and for those~     with anterior cross pelvis syndrome a posterior support will be made in the insole. For the~     placebo group, the insole will be made of the same material as that of the custom insoles,~     although, without support.~   "
16510|NCT03350854|"~     The goal of this project is to test the effects of the Patient Preference Scale as the basis~     for a clinical intervention for role negotiation in breast cancer surgery decisions and the~     Patient Perception Scale to measure role concordance. The investigators hypothesize that~     better role concordance will be achieved with a simple provider-based intervention. In the~     first half of the study, providers will be blind to the patient's preferred role. In the~     second half, providers will be made aware of the preferred role prior to the encounter and~     will have a brief conversation with the patient about their desired role in the decision~     making process.~   "
16511|NCT03350841|"~     randomized clinical trial which Evaluate thr Post-operative Pain Following Platelet Rich~     Plasma (PRP) Revascularization versus Conventional Endodontic Treatment of Non-vital Mature~     Mandibular Molars with Chronic Peri-apical Periodontitis~   "
16512|NCT03350828|"~     This is a multicenter, cross-sectional, cohort study which will collect contemporary SC~     values from approximately 1000 CF patients prescribed and currently receiving commercially~     approved CFTR modulator therapies.~   "
16513|NCT03350815|"~     Study estimating the clinical difference between 300 mg and 150 mg of secukinumab following~     dose escalation to 300 mg in patients with ankylosing spondylitis~   "
16514|NCT03350802|"~     The purpose of this study is to evaluate the usefulness of procalcitonin test for~     differentiation of the cause of pneumonia in patients with cancer.~   "
16515|NCT03350789|"~     This research is planned to build a basis about the efficacy and mechanism of acupuncture on~     pain and emotional disorder in patients with chronic sciatica using fMRI.~   "
16516|NCT03350776|"~     Several stakeholders are implied in cancer care pathways and there is a need for coordinating~     their actions. New occupations of care coordination have thus emerged. However, the~     conditions of their efficiency have been too few reported and included discrepancies between~     reports. In this context, the main objective is to propose a modeling of care coordination~     and associated emerging occupations (nurse-based) by comparing theoretical expected outcomes~     to professionals, patients and caregivers representations.~   "
16517|NCT03350763|"~     This study looks in to the rate of biliary stent dysfunction for plastic and metallic stents~     in patients who need biliary drainage due to a tumor in pancreas before possible~     pancreaticoduodenectomy. Complications related to the biliary decompression, and possible~     post-surgical complications in all patients are also recorded.~      This trial aims to confirm whether metallic biliary stents really are superior to plastic~     stents as some previous studies suggest. Specific patient groups are also evaluated~     individually to see, whether patients with ongoing cholangitis at the time of diagnosis or~     patients receiving neoadjuvant treatments have less stent dysfunction cases and complications~     with metallic stents than with plastic stents.~   "
16518|NCT03350750|"~     The Placebo-Controlled Effectiveness in Idiopathic Normal Pressure Hydrocephalus (iNPH)~     Shunting (PENS) trial is a multi-center blinded, randomized, placebo-controlled design~     investigation of cerebrospinal fluid (CSF) shunt surgery to study the shunt effectiveness in~     iNPH patients.~   "
16519|NCT03350737|"~     This study evaluates the addition of heparin to a 2-week cycle of physical rehabilitation in~     the treatment of refractory angina. Half of the patients will undergo heparin-primed physical~     rehabilitation, while the other half will undergo only physical rehabilitation.~   "
16520|NCT03350724|"~     The hypothesis for the present study is that patient-based outcomes and gingival blood flow~     will be more favorable for the free gingival graft (FGG) donor sites being covered by the~     test wound dressing material episil compared to the control dressing.~   "
16521|NCT03350711|"~     The goal of this study is to rapidly identify subjects who are eligible for the Microbiota~     Enrichment Program (MEP) at Emory in Atlanta, Georgia. This general screening protocol will~     be used to screen potential subjects for the Emory MEP and will be conducted at the Emory~     Clinic, the Hope Clinic of the Emory Vaccine Center and/or Emory affiliated hospitals. An~     electronic database will be created to capture demographic and medical information about~     individuals who are reaching out to obtain fecal microbiota transplant (FMT) and pre-screen~     these potential study participants for current and upcoming studies within MEP.~   "
16522|NCT03350698|"~     Currently there are no standards for healthcare worker vaccination with the HPV, Gardasil-9~     vaccine. For health care workers, the CDC only recommends for vaccination against hepatitis~     B, influenza virus, Measles, Mumps and Rubella (MMR), Chickenpox (Varicella), Tetanus,~     Diptheria, and Pertussis (Tdap), and meninogococcal infections6~   "
16523|NCT03350685|"~     Whipple's disease is a chronic systemic infection caused by ubiquitous bacterium Tropheryma~     wipplei on a genetic predisposition which should be considered in patients with recurrent~     episodes of seronegative arthritis, erosive or not, or inflammatory low back pain, chronic~     diarrhea, persistent fever, unexplained neurological signs, uveitis, endocarditis, and~     epithelioid granuloma.~      Laboratory tests may show malabsorption, erythrocyte sedimentation rate and C-reactive~     protein elevation, anemia, thrombocytosis, eosinophilia and lymphopenia.~      None of theses findings is specific and most patients have arthritis or low back pain~     mimicking rheumatoid arthritis and spondyloarthritis.~      As the disease is rare, chance for positive polymerase chain reaction testing for Tropheryma~     whipplei is low in this context.~   "
16524|NCT03350672|"~     Pre-exposure prophylaxis (PrEP) with Truvada™ (tenofovir/emtricitabine), in which an~     HIV-uninfected individual at high risk for contracting HIV takes antiretroviral medications~     (one pill daily) to maintain blood and genital drug levels sufficient to prevent HIV-1~     acquisition, has been validated in several large international trials that have included men~     who have sex with men and transgender women, heterosexual men and women, and people who use~     injection drugs, as a potential HIV-1 prevention strategy. HIV prevention interventions such~     as this, if adequately disseminated and implemented broadly, may help to curb new HIV~     infections, reduce HIV-associated morbidity and mortality, and reduce health disparities in~     HIV rates among the most at-risk individuals. Assuring adherence to a daily dose of PrEP is~     critical for effective protection against HIV infection. A urine-based test to measure PrEP~     medication levels in the body represents a non-invasive technique to assess adherence and~     ultimately improve PrEP's protective ability.~      TAF/FTC (Descovy™) is a new medication under study for HIV prevention to see if it is as~     effective as Truvada™. This study is testing whether a urine test can detect this medication~     in urine.~   "
16525|NCT03350659|"~     This was a randomized, open-label clinical trial. We will enroll patients with symptomatic~     neurogenic OH and randomize them to 1 of 2 treatments: (1) midodrine only, (2) atomoxetine~     only. We will follow up patients at 1 and 3 months after treatment. If the patients meet BP~     criteria for OH at 1 month, they will receive combination treatment with both midodrine and~     atomoxetin. The primary outcome measure is amelioration of questionnaire score evaluating~     OH-associated symptoms at 3 months. Secondary end-points were improvement in orthostatic~     blood pressure (BP) drop at 1 and 3 months.~   "
16526|NCT03350646|"~     The aim of this study was to evaluate if higher volume (40-45μl VS 20-25 μl) of media used~     for embryo transfer affects the clinical outcomes in fresh IVF cycles.Patients who fulfilled~     the inclusion criteria and agreed to participate in the study, were randomized, on the day of~     the embryo transfer, into group A: low volume (20-25 μL) and group B: high volume (40-45 μL)~   "
16527|NCT03350633|"~     In neuromyelitis optica spectrum disorder (NMOSD),interleukin-6 (IL-6) may play an important~     role in facilitating plasma cells to produce pathological aquaporin 4 (AQP4) autoantibody.~     Inhibition of IL-6 signaling pathway by Tocilizumab (ACTEMRA®), a humanized monoclonal~     antibody may have shown beneficial clinical effects in a few patients with NMOSD.~      Larger scale clincial trials may be needed to observe its efficacy and safety. Here, by~     choosing azathioprine, one of the most frequently used medication in case of relapses, the~     investigators compare the safety and efficacy of tocilizumab in preventing NMOSD attacks.~   "
16528|NCT03350620|"~     Stage 1: To evaluate the safety and efficacy of 2 concentrations of NVK-002 compared to~     Vehicle (placebo) for slowing the progression of myopia in children over a 3 year treatment~     period.~      Stage 2: To observe safety and efficacy in subjects re-randomized to one (1) year of~     treatment with NVK-002 or Vehicle following 3 years of treatment in children with progressive~     myopia.~   "
16529|NCT03350607|"~     Epiretinal membrane (ERM) is a pathological phenomenon requiring surgery when vision is~     altered.~      ERM surgery requires ERM peeling, then active internal limiting membrane (ILM) peeling if it~     is not spontaneously peeled with ERM. Initiation of peeling is very delicate and can lead to~     micro scotoma when realized with microscopic forceps. The Sweeper is a microscopic tool with~     a soft silicon tip covered with diamond dust which allows peeling initiation without retina~     prehension. It may reduce retinal trauma and visual sequelae.~      Purpose of our study is to evaluate use of sweeper during 20 ERM surgeries. The investigator~     will compare microperimetry before surgery versus those after 1 month (M1) and 3 months (M3),~     and measure difference of number and depths of micro scotoma.~      The investigator will note: number of forceps uses if sweeper is inefficient and all areas of~     sweeper use to correlate them with micro scotoma.~      The investigator will evaluate visual and optical coherence tomography improvement after~     surgery.~   "
16530|NCT03350594|"~     The aim of this study is to evaluate whether the implementation of Multiple Family Therapy~     (MFT) within a multi-disciplinary treatment program for Anorexia Nervosa (AN) in adolescence~     is at least as effective in terms of clinical Body Mass Index evolution as single Systemic~     Family Therapy (SyFT) after 12 months of treatment. We expect that these two techniques will~     not differ in terms of global efficacy, but that MFT could be more suitable for certain~     profiles who may be less responsive to SyFT.~   "
16531|NCT03350581|"~     The purpose of the study is to investigate whether or not there are the differences in acute~     procedure and long-term clinical outcome of radiofrequency catheter ablation (RFCA) for~     atrial fibrillation (AF) using the 3D map constructed by the integration of CT(or MRI) with~     the fast anatomical mapping (FAM) versus using the 3D map constructed by FAM only.~   "
16532|NCT03350568|"~     Dietary antioxidants might protect from the development of chronic diseases by reducing~     levels of oxidative stress. The investigators therefore investigated the effect of dietary~     Non Enzymatic Antioxidant Capacity, which measures interactions between antioxidants in the~     whole diet, on the risk of 1) myocardial infarction and 2) osteoarthritis.~   "
16533|NCT03350555|"~     Validation of clinical use of additioned endoscopy in Endoscopic Retrograde~     Cholangiopancreatography(ERCP) treatment.~   "
16534|NCT03350542|"~     EVOLVE 48 is a prospective, open label, single arm, multi-center trial. The purpose of this~     study is to assess the FDA requirement for safety and effectiveness of the SYNERGY 48 mm~     Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) > 34 mm~     and ≤ 44 mm in length (by visual estimate) in native coronary arteries ≥2.5 mm to ≤4.0 mm in~     diameter (by visual estimate).~   "
16535|NCT03350529|"~     This study assesses feasibility and safety, the primary outcomes, of MRI guided transurethral~     high intensity focused ultrasound (HIFU) ablation for prostate diseases (PD). We will enrol~     10 patients to each group with criteria as follows: localised prostate cancer (PC); locally~     advanced PC; locally recurrent PC after external beam radiation therapy (EBRT); benign~     prostatic hyperplasia (BPH). Secondary outcomes are both oncologic and functional outcomes~     and imaging based follow up after HIFU therapy will be also assessed.~   "
16550|NCT03350334|"~     The aim of the investigators of the study is to evaluate the effect of peri-operative~     duloxetine on post-operative recovery in patients undergoing laparoscopic hysterectomy.~   "
16551|NCT03350321|"~     The purpose of this study is to evaluate the efficacy and safety of molidustat in~     non-dialysis subjects with renal anemia who are not treated with Erythropoiesis-Stimulating~     Agents (ESAs).~   "
16536|NCT03350516|"~     The World Health Organization currently recommends that pregnant women in populations with~     low calcium intake receive daily calcium supplementation (1500 - 2000 mg) divided into three~     doses which are preferably taken at mealtimes, in addition to daily iron folic-acid~     supplements. Despite proven efficacy and the WHO recommendation, calcium supplementation in~     pregnancy is not standard of care in the vast majority of low-income and middle-income~     countries. Two important barriers to implementation are the cost of the supplements and~     complexity of the suggested calcium dosing schedule. A lower dose of calcium (500 mg)~     administered as a single dose has been shown to be beneficial in several trials, and if found~     to be as effective as the 1500 mg supplementation regimen, it may help overcome these~     barriers and increase individual and health system adoption.~      The Investigators will conduct two parallel, individually randomized, double blind~     non-inferiority trials in India and Tanzania. Participating pregnant woman will be randomized~     to either 1500 mg or 500 mg calcium supplementation. The India and Tanzania trials are~     independently powered for the primary outcomes of i) preeclampsia and ii) preterm birth. The~     India and Tanzania sites will each enroll 11,000 participants.~   "
16537|NCT03350503|"~     The purpose of this study is to clinically confirm the rotational stability of a modified~     AcrySof IQ toric intraocular lens (IOL) in a Japanese population.~   "
16538|NCT03350490|"~     The aim of this study is the synergistic effect of cancer ablation and life information~     rehabilitation therapy on unresectable intestinal cancer.~   "
16539|NCT03350477|"~     The aim of this study is the synergistic effect of cancer ablation and life information~     rehabilitation therapy on unresectable gastric cancer.~   "
16540|NCT03350464|"~     Transcranial magnetic stimulation (TMS) is a procedure that has been shown to improve pain in~     chronic sufferers. It is a well-tolerated procedure that can be performed on an outpatient~     basis. It uses a plastic covered coil that sends a magnetic pulse through the skull into the~     brain and by targeting particular areas in the brain it can be used to help modulate the~     perception of pain.~      The study intends to use this technique to treat such a disabling symptom in patients who~     suffer from Parkinson's Disease (PD). Initially the aim is to study this technique in ten~     patients who are suffering from pain and have PD. These patients would initially require an~     MRI scan which allows us to map the brain and target the correct brain areas for the delivery~     of the stimulation. The stimulation would be performed over ten sessions and the patients~     would be assessed by a clinician using well recognized clinical tools.~      It is anticipated that there will be a meaningful improvement in pain. It is also anticipated~     that TMS is a safe technique to use in patients with PD. The study will be used to help plan~     a future study that compares TMS with sham technique to prove whether TMS could be an option~     in the treatment of such a disabling condition.~   "
16541|NCT03350451|"~     The purpose of this study is to evaluate the long-term safety and tolerability of ALN-GO1 in~     patients with Primary Hyperoxaluria Type 1.~   "
16542|NCT03350438|"~     This study assesses the relationship between participation and quality of life the way adults~     with and without Post Traumatic Stress Disorder (PTSD) experience it in everyday life. Both~     groups will fill out Questionnaires and the answers will be compared. In addition different~     aspects of dissociation will be taken in to consideration.~   "
16543|NCT03350425|"~     The investigators compare two strata of vaccinated patients: those recently vaccinated and~     those vaccinated more than two years ago. The primary objective is to compare pneumonia rates~     between the groups. As exploratory objectives, the investigators will describe the~     anti-pneumococcal antibody titers in hemodialysis patients as a function of time since~     vaccination, and determine factors influencing antibody kinetics. Further exploratory~     objectives investigate the relationship between antibody titers and the incidence of~     pneumonia in hemodialysis patients and extrapolate a possible cut-off for protection from~     pneumonia.~   "
16544|NCT03350412|"~     The goal of delivering the right drug to the right cancer patient (precision medicine)~     requires a detailed understanding of how genomic alterations are linked to drug response. The~     purpose of this study is to intercept at point-of-care a large cohort of newly diagnosed mCRC~     patients to determine if it is possible to obtain personalized genetic information from each~     subject's tumor (tissue and blood) to triage treatment choices. In case of target positivity,~     patients will be conveyed, whenever possible, to self-standing, independent,~     hypothesis-driven POC trials as soon as they exhibit resistance to standard of care~     treatment.~   "
16545|NCT03350399|"~     Type of the study:~      A prospective observational study~      Study settings:~      The study will be conducted at Ain Shams University Maternity Hospital, Obstetrics and~     Gynecology Department, Faculty of medicine over a period of six month from July 2017 to~     December 2017.~      Study population:~      The study population comprises 60 pregnant women at 13 to 28 week of gestation attending~     outpatient clinic and emergency Ain Shams University Maternity Hospital, Obstetrics and~     Gynecology Department, Faculty of medicine.~      Sample size justification Sample size was calculated using PASS 11.0 sample size calculation~     program and based on the study carried out by Benton, et al. (2016) Group sample sizes of 30~     in group one (IUGR) and 30 in group two (Controls) achieve 80% power to detect a difference~     between the group proportions of 0.2910. The proportion in group one (the treatment group) is~     assumed to be 0.2940 under the null hypothesis and 0.5850 under the alternative hypothesis.~     The proportion in group two (the control group) is 0.2940. The test statistic used is the~     two-sided Z test with pooled variance. The significance level of the test was targeted at~     0.0500. The significance level actually achieved by this design is 0.0506. The primary~     outcome is birth weight below the 10 the percentile. The sample size was inflated by 15.0% to~     account for lost to follow up (attrition problem).~      Inclusion criteria:~      Singleton pregnancy between 13-28 weeks of gestation. Pregnant women aged 18 - 35 years~     Pregnant women with fetal abdominal circumference (AC) < 10th percentile for gestational age~     (GA) on ultrasound~      Exclusion criteria:~      To exclude any factors that cause IUGR:~      Chronic or gestational hypertension and/or preeclampsia Premature rupture of membranes A~     fetus with known chromosomal and/or congenital abnormalities confirmed after delivery.~      Multiple gestation~   "
16546|NCT03350386|"~     This is an open-label, 2-period add-on study to assess the drug-drug interaction between~     FYU-981 and oxaprozin. The purpose of this study is to investigate the pharmacokinetics of~     each period in a single administration of FYU-981 and concomitant administration of FYU-981~     with oxaprozin at steady -state in healthy volunteers.~   "
16547|NCT03350373|"~     This is a randomized, open-label, 2-period crossover study. The purpose of this study is to~     assess the pharmacokinetics and safety after single oral administration of final formulation~     of FYU-981 to healthy male adults in fasted and fed conditions. Participants are randomized~     to fasted (n=6) or fed conditions (n=6) in each step. The effect of food to pharmacokinetics~     of FYU-981 is also investigated.~   "
16552|NCT03350308|"~     The main objective is to establish a statistical predictive model of the risk of~     intradialytic hypotension during hemodialysis (HD) or hemodiafiltration (HDF) sessions based~     on the measurement of residual blood volume and excess extracellular hydration. The secondary~     objective is to study the impact of dysfunction in the mechanisms of compensation for~     decreased blood volume (heart disease, neuropathy, drugs) on the risk of intradialytic~     hypotension.~   "
16553|NCT03350295|"~     Study to assess the relative Bioavailability To assess the relative bioavailability of three~     formulations of nifurtimox 30 mg tablets exhibiting different in vitro dissolution profiles~     To assess the pharmacokinetics (PK) of nifurtimox To investigate the safety and tolerability~     of nifurtimox.~   "
16554|NCT03350282|"~     Co-administration of creatine and guanidinoacetic acid (GAA) has been recently put forward as~     an advanced dietary strategy to optimize tissue bioenergetics. The investigators hypothesized~     that creatine-GAA mixture would result in more powerful rise in brain and skeletal muscle~     creatine, as compared to creatine supplementation alone.~   "
16555|NCT03350269|"~     The study is designed as a randomized controlled trial. The investigators hypothesize that~     kidney transplant recipient candidates whose donors are offered reimbursement of lost wages~     (treatment arm) will have a higher probability of receiving a living donor kidney transplant~     than those randomized to no offer of lost wage reimbursement (control arm). The study expects~     to demonstrate incremental living donor kidney transplants by assisting individuals who wish~     to be living organ donors but would be otherwise unable to do so due to the obligatory~     forfeit of income during the evaluation, donation surgery, and post-operative recuperation~     periods.~   "
16556|NCT03350256|"~     The purpose of this study is to evaluate the therapeutic efficacy of microdosing BurstDR~     stimulation in spinal cord stimulation (SCS) patients with chronic intractable back and/or~     leg pain.~   "
16557|NCT03350243|"~     This study will evaluate a new neonatal follow-up model that offers additional support and~     coping resources for parents during their child's NICU admission as well as during their~     transition home. The Coached, Coordinated, Enhanced Neonatal Transition (CCENT) model~     involves a key worker who will be the primary support for families during the first year of~     their child's life. The key worker's role involves 1) parental coaching using a~     mindfulness-based approach, 2) helping coordinate care across various levels of care as well~     as supporting families in system and resource navigation, and 3) provided proactive education~     targeting normal challenges in caring for a child who required intensive care support. The~     goal is to improve the psychosocial support and medical care coordination beyond the neonatal~     intensive care unit as many of the medical and social concerns do not end at the time of~     discharge.~   "
16558|NCT03350230|"~     looking at aneuploidy rates in embryos from patients who are going to or have undergone~     treatment for a malignancy with gonadotoxic treatment.~   "
16559|NCT03350217|"~     EMR is a technique used for the removal of flat or sessile neoplasms confined to the~     superficial layers of the GI tract using a snare. Injection-assisted EMR is commonly used~     during resections of larger flat lesions as it provides submucosal lift of polyps, adenomas,~     other gastrointestinal mucosal lesions or early-stage cancers prior to EMR. This has been~     found to minimize mechanical or electrocautery damage to the deep layers of the~     gastrointestinal tract wall as the injectate provides a safety cushion as such between the~     area to be removed and healthy mucosal tissue.~      Several solutions are used today for injecting lesions including saline, hyaluronic acid, and~     hydroxyethyl starch (Hetastarch). Saline solution has been found to dissipate within minutes,~     which may result in a lower quality lesion lift. Hyaluronic acid provides a longer lift, but~     is expensive and is not readily available in the U.S.~      A new injectate known as Eleview has been developed for use in gastrointestinal endoscopic~     procedures and recently approved by the FDA. This injectate boasts a cushion of excellent~     height and duration through the use of an oil-in-water emulsion. However, the initial cost of~     this material is quite high ($80 per 10 ml).~      Hetastarch, which is the current injectate used by Dr Rex, is a safe and considerably~     inexpensive solution that provides prolonged submucosal elevation and lowers procedure times.~     Our study will aim to compare Eleview to Hetastarch in the hopes of finding the ideal~     submucosal injectate.~      This trial will focus on polyps of size ≥11 mm removed by snare EMR technique. Patients with~     lesions deemed not suitable for EMR due to features suggestive of sub-mucosal invasion will~     not be included.~   "
16560|NCT03350204|"~     The key aim of this study is to examine biomechanical measures associated with osteoarthritis~     (OA) progression in patients who have lateral and medial menisci injuries during various~     tasks. The likelihood is that individuals who have a meniscal injury often develop knee~     osteoarthritis. Therefore understanding biomechanical changes from the injury, specifically~     undertaking both functional and sporting activities, may provide a conservative approach to~     delaying or minimising the development of OA. Three-dimensional kinetic and kinematic~     measures will be assessed during seven tasks (walking, running, side cuts, single leg~     landing, small knee bend squat and isokinetic leg strength), prior to and following~     treatment. In addition, Strength and balance will be assessed to indicate if there is more~     work in the rehabilitation program that is needed for functional movement.~   "
16561|NCT03350191|"~     Primary Objectives:~      To assess in overweight to obese T2DM patients:~        -  The glucagon receptor occupancy of SAR425899 at two dose levels in the human liver with~          positron-emission tomography (PET) imaging using [68Ga]Ga-DO3A-VS-Cys40-Tuna-2 as a~          tracer compound.~        -  The GLP-1 receptor occupancy of SAR425899 at two dose levels in the human pancreas with~          PET imaging using [68Ga]Ga-DO3A-VS-Cys40-Exendin-4 as a tracer compound.~        -  Pharmacodynamic effects on fasting plasma glucose and biomarkers of lipid metabolism.~        -  Pharmacokinetic parameters for SAR425899 after repeated subcutaneous (SC) doses in~          plasma.~        -  Safety and tolerability of SAR425899.~   "
16562|NCT03350178|"~     ICU patient's complications are notably due to multiple infections with high risks of sepsis.~     Those infections would be worsened by any antibiotic resistance mechanism. Thus, reducing MDR~     portage in health care unit is a global strategy that will benefit for the patients and the~     health system organization. Fecal Microbiota transfer and restoration is a promising strategy~     to achieve this purpose.~   "
16563|NCT03350165|"~     A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate~     the Efficacy and Safety of Pemafibrate in Patients With Nonalcoholic Fatty Liver Disease.~   "
16564|NCT03350152|"~     The treatment of very elderly patients (≥70 years) with acute myeloid leukemia remains~     controversial. Although the outcome in younger adults has improved because of cytarabine- and~     anthracycline-based chemotherapy with advanced supportive care and introduction of~     hematopoietic stem cell transplantation, the benefit associated with standard intensive~     chemotherapy in older patients remain debatable. Life expectancy in elderly patients is a~     function of age, disability and comorbidity, performance score, along with leukemia~     characteristics such as genetic alterations or white blood cell count at diagnosis 'Older'~     patients are generally considered those aged 60 years or older.~      Intensive chemotherapy delivered to the very elderly with AML (patients _70 years of age),~     may not be beneficial to most and could be harmful to some. However, these patients are often~     referred to as 'unfit' or ineligible for intensive remission induction therapy. In daily~     practice, the final decision to treat intensively or not is made by the treating hematologist~     on a case by case basis according to patient's age, cytogenetics, performance score,~     concomitant diseases and type of AML (de novo or secondary).~      In older patients considered 'unfit' for intensive treatment, LD-AraC has been demonstrated~     to be more beneficial than best supportive care and hydroxyurea. The recent availability of~     new drugs that may have an improved side effect profile and in some cases bioavailability may~     offer future improvement for this patient population. The efficacy of hypomethylating agents~     has been studied in older AML patients with conflicting results. Recent publications refined~     prognostic information, which not only optimize existing treatments but also could lead to~     the development of additional targeted therapeutic approaches.~      In this study, the investigators focus on patients with AML (_20% blasts) aged 70 or older~     seen in our institution over a 14-year period. The objectives of the analysis are to describe~     the demographic, clinical and biological characteristics of this population and to evaluate~     how these characteristics and the treatment chosen affect~   "
16565|NCT03350139|"~     Gamma-Knife radiosurgery of the VIM for patients presenting with severe drug-resistant tremor~     is now current practice as an alternative to Deep Brain Stimulation (DBS) of the VIM.~      Now, around 100 patients are treated annually in our unit (essential tremor or Parkinson~     tremor).~      Clinical and radiological follow-up is demonstrating that 80% of these patients are~     presenting with a homogenous response complete or subtotal, the disappearance of the tremor~     mean delay of 6 months after radiosurgery. In neuroradiological responses on the MRI, is~     appearing roughly at the same time local contrast enhancement surrounding highty to signal no~     associated with clinical side effects.~      In 15 to 20% of the patients, the clinical effets is not obtained and in the vast majority no~     MRI response or minimal MRI response is observed on images suggesting that these failures are~     related to specific resistance to radiosurgery of this subgroup.~      In roughly 5% of the patients, at the contrary, hyper response is observe on the MRI rating~     clinically with side effects (hemiparesis or proprioceptive ataxia or dysarthria, hands~     problems….). The adverse effects are generally reversible either in whole or in part with the~     resorption of the perilesionnel oedema.~      It would be extremely helpfull to be able to identify in advance these 2 groups of hyper and~     hypo respondeurs.~      The capacity to identify in advance these patients at risk to hypo or hyper response would~     allow us to either contre-indicate radiosurgery or modify radiosurgery technicaly at the time~     of dose planing.~      Sequently, these predictions would allow us to tailor individually mission management and~     information leading to improvment of the efficacy and tolerance of this kind of intervention.~      The parameters suspected to be likely to influence the response are :~        -  genetics~        -  co-morbidities (diabetis, vascular…)~        -  Main aspect of the brain (severe atrophy, vascular, micro-infacts…)~        -  Chronobiological (timing during the day of the radiosurgical procedure)~        -  Associated medication (potential radioprotector or radiosensitizer effect of some drugs)~        -  Radiobiological (dose rate…)~      The goal of this study is to collect all of these informations out of genetical one in the~     cohort of 700 patients having benefited ou will benefit from radiosurgery in the situation~     for essential tremor and parkinson disease. It will be test the predictive value of these~     parameters and the capacity to predict hyper or hypo response.~      The work on the genetic material will take place in the second stage in the frame of a new~     different resarch project.~   "
16566|NCT03350126|"~     This is a non-randomized study, open label phase II study. The purpose of this study is to~     evaluate disease control rate (DCR) by RECIST and iRECIST at 12 weeks.~      Evaluation of RECIST and iRECIST will be done in each center in order to choose the optimal~     therapy (Assessment by Investigators).~      A centralized evaluation of RECIST and iRECIST, will be organized in Saint-Antoine.~   "
16567|NCT03350113|"~     A diagnostic devise, namely HemoSpec, had been developed that integrates clinical~     information, along with information on circulating protein biomarkers and the morphology of~     white blood cells to achieve early diagnosis of sepsis. The current study is aiming to~     validate and improve performance of HemoSpec for the rapid assessment of the critically ill~     patient in the Emergency Department.~   "
16568|NCT03350100|"~     A number of studies have considered the neuroprotective effects of date fruit on~     neurodegenerative diseases in animals. However, so far no study has addressed the acute~     effects of date fruit on mood and cognitive performance in humans. This study will~     investigate the acute effects of two different cultivars of Saudi dates on mood and cognitive~     performance into healthy volunteers.~      This study will follow a double blind, randomised, placebo controlled, repeated measures,~     cross over design with two active treatment arms versus placebo. Treatment orders will be~     counterbalanced with the use of a Latin Square design.~      Thirty six healthy participants aged between 18 and 35 will be recruited. Participants will~     be required to undergo a screening/training visit, followed by three measurement visits at~     weekly intervals. The trial will last for 3 months in total.~   "
16569|NCT03350087|"~     Stroke is the major cause of motor impairment and physical disabilities in the adult~     population. Spasticity and loss of dexterity are the common problems in stroke. Recently,~     current interventions, such as cycling training, virtual reality (VR) and repetitive~     transcranial magnetic stimulation (rTMS), were used for the treatment of upper extremity (UE)~     dysfunction in patients with stroke. However, few studies investigated the effects of the~     combinations of different treatment strategies using by integrating brain imaging and motor~     control studies. This project proposes different novel treatment strategies in the treatment~     of UE dysfunction in patients with stroke: combined inhibitory/facilitatory rTMS, VR-based~     cycling training (VCT), and combined rTMS and VCT. We hypothesize that the treatment effect~     of the combined protocol (optimal rTMS protocol and VCT) is more effective than single~     treatment due to integration of central and peripheral effects. Different treatment protocols~     will induce different changes in the brain reorganization and motor control, which further~     improve motor function, activity, participation, and health related quality of life (HRQOL).~   "
16570|NCT03350074|"~     Hepatitis B virus (HBV) infection remains difficult to eradicate with about 240 million~     people living with HBV chronic infection. HBsAg clearance, correlated with a good clinical~     prognosis, is difficult to achieve even with antiviral treatments (3-14 %). HBV envelope~     proteins are essential for entry into hepatocyte and are targeted by the immune system.~     Molecular characteristics of HBV envelope proteins may favour better viral fitness at the~     entry step into hepatocytes and/or HBV escape from host immunity. Here we investigated~     whether variability of HBV envelope proteins can contribute to the differential responses to~     anti-HBV treatment in patients with HBsAg clearance or persistence.~   "
16571|NCT03350061|"~     Lower limb amputees suffer complete lack of sensory feedback of current available prostheses,~     which excludes the central nervous system from the correct sensory-motor integration. It~     causes serious problems as: falls due to unexpected perturbations, asymmetric walking, low~     mobility, higher power consumption, feeling the prosthesis as a foreign body, high cognitive~     burden, and phantom limb pain occurrence.~      Investigators will provide amputees with a prosthesis restoring sensory feedback and will~     assess its benefits on the users.~   "
16572|NCT03350048|"~     Title: Evaluation of host biomarker-based point-of-care tests for targeted screening for~     active TB (Screen TB)~      Introduction: Tuberculosis (TB) places severe pressure on health care services of the~     developing world. Despite the introduction of the highly sensitive and specific GeneXpert~     MTB/RIF (GeneXpert) test [1] with a potential turn-around time of two hours, many people in~     high TB prevalence areas still do not have access to efficient TB diagnostic services due to~     logistical constraints in these settings. A cost effective, rapid, point-of-care screening~     test with high sensitivity would identify people with a high likelihood for active TB and~     would prioritize them for testing with more expensive, technically or logistically demanding~     assays including GeneXpert or liquid culture, facilitating cost-effective diagnostic work-up~     in resource-limited settings. A serum cytokine signature for active TB disease, discovered in~     the AE-TBC project, with a sensitivity of 89% (CI 78 - 95%) and specificity of 76% (CI 68 -~     83%), will be optimised and utilized in a point-of-care format (TransDot) to rapidly test for~     TB disease in symptomatic people.~      Hypothesis: The TransDot test will achieve a sensitivity of > 90% for TB disease, in a~     training set of people suspected of having TB disease, and be validated (achieve similarly~     high sensitivity) subsequently in a prospective test set of people suspected of having TB~     disease, when compared to a composite gold standard of sputum culture, smear, GeneXpert,~     chest X-ray, TB symptoms and TB treatment response.~      Objectives: The overall objective of the study is to incorporate a six-marker serum signature~     into a multiplex UCP-LFA format, referred to as TransDot, for finger-prick blood testing. The~     end point of the study is the accuracy (sensitivity and specificity) of the UCP-LFA TransDot~     test on finger-prick blood for active TB and will be prospectively compared against gold~     standard composite diagnostic criteria (GeneXpert, MGIT culture, TB sputum smear, CXR, TB~     symptom screen and response to TB treatment).~      Primary: The primary outcome of interest will be accuracy, sensitivity and specificity of the~     TransDot finger-prick test when compared with the composite gold standard tests.~   "
16573|NCT03350035|"~     This study will evaluate the effectiveness and safety of an investigational drug, IV~     ganaxolone, as adjunctive therapy to standard of care to treat subjects with status~     epilepticus.~   "
16574|NCT03350022|"~     The purpose of this pilot study is to evaluate a feeding technique, sham feeding, to promote~     adequate oral skills in order to prevent oral aversion and/or poor oral skills due to the~     delay in oral feeds for surgical reasons. Sham feeding is intended for infants who are~     expected to have a prolonged course without normal enteral feeding by mouth.~   "
16575|NCT03350009|"~     Assessment of the quality of follicular fluid and early embryo via chemical markers.~   "
16576|NCT03349996|"~     The BELSTREAM Trial investigates the efficacy of the LifeStream Peripheral Stent Graft System~     in the treatment of iliac stenotic or occlusive lesions (TASC C and D). An expected total of~     70 patients will be treated. The lesion is located within the native Iliac arteries. Prior to~     stenting with the LifeStream Peripheral Stent Graft System, pre-dilatation can be performed~     according to the physician's discretion. Also post-dilatation can be performed according to~     the physician's discretion. Patients will be invited for a follow-up visit at 1, 6 and 12~     month post-procedure. The primary efficacy endpoint of the study is the primary patency at 12~     months. The primary safety endpoint is the freedom of periprocedural Serious Adverse Events~     (SAEs). Secondary endpoint include primary patency rate at 1 and 6 month, stent graft~     occlusion rate at pre-discharge, 1, 6 and 12 month follow-up, anke-brachial index (ABI) at 1,~     6 and 12-month follow-up, amputation rate at 1, 6 and 12-month follow-up, technical success~     and clinical success at 1, 6 and 12-month follow-up.~   "
16577|NCT03349983|"~     An open-label Phase 1 trial to evaluate the safety and tolerability of MVA-BN-Brachyury~     priming and FPV-Brachyury boost vaccines modified to express brachyury and T-cell~     costimulatory molecules in patients with a metastatic or unresectable locally advanced~     malignant solid tumor. Subjects will be given the following subcutaneous doses: two prime~     doses with MVA-BN-Brachyury and monthly boost doses with FPV-Brachyury for 6 months. The~     study will last approximately 104 weeks before starting long term follow up (FU).~   "
16578|NCT03349970|"~     Transesophageal echocardiography (TEE) has become a standard monitoring tool during cardiac~     surgery. It allows continuous accurate assessment of heart structures and function without~     interfering with the surgery and the anesthetics. The imaging of cardiac structures is used~     to direct optimal surgical intervention and assess surgical results. Cardiac output (CO) is~     the result of stroke volume (SV) multiplied by the heart rate.~      Measurement of cardiac output (CO) is used to quantify the performance of the left ventricle.~     It is commonly achieved using a pulmonary artery catheter (PAC) (also known ad Swann-Ganz~     catheter). A known amount of saline solution is injected in the proximal part of the catheter~     and the variation of blood temperature detected at the tip. Cardiac output is measured based~     on the duration and degree of temperature change. This method remains an accepted gold~     standard. TEE allows measurement of cardiac output using a number of different 2D and 3D~     imaging modalities. Although current guidelines identify the Method of the Disks(MOD) as the~     gold standard other technique could potentially be more precise. In this study, the~     investigators want to assess the accuracy of four different TEE methods to measure cardiac~     output compared with Thermodilution as a standard of care.~   "
16579|NCT03349957|"~     DcBeads and lipiodol-transarterial chemoembolization (TACE) of hepatocellular carcinoma (HCC)~     using doxorubicin result in about 50% objective response rate at 6 months (Precision V study,~     Lammer et al. CVIR 2010) We previously demonstrated that idarubicin was the most effective~     drug on 3 HCC cell lines (Boulin et al., Anticancer drugs 2009). We tested idarubicin-loaded~     beads in a phase I trial (Boulin et al., Aliment Pharmacol Therapy 2012) and more recently in~     a prospective multicentric phase II trial (IDASPHERE II, Magna Cum Laude CIRSE 2017, B Guiu~     et al.). This trial was stopped at interim analysis because the endpoint was reached.~      Tandem beads are precisely calibrated, of small size, allowing the maximization of ischemic~     effects together with an optimal efficacy of the drug. We previously published that~     idarubicin was able to load fastly in Tandem, with minimal modification of bead diameter and~     a very interesting releasing profile of the drug (Guiu et al., JVIR 2015).~      We used TANDEM combined with idarubicin in our practice for the treatment of HCC by TACE~     (in-label use of beads and the drug).~      No clinical study (even retrospective) has been published so far with TANDEM-IDA (except our~     first paper published in JVIR in 2015, only 4 patients).~      Here we propose to collect the retrospective data of patients treated by TANDEM-IDA, to help~     to design a future multicentric randomized phase II trial~   "
16580|NCT03349944|"~     The project will investigate high intensity interval training on the glucose regulation in~     type 2 diabetic subjects compared to moderate continuous exercise.~   "
16581|NCT03349931|"~     The purpose of this study is to evaluate the performances of the real-time PCR ADEMTECH kit~     of DNA extraction and detection of Aspergillus fumigatus in serum samples in patients at~     high-risk for invasive aspergillosis (IA). DNA detection will be associated with detection of~     TR34/L98H mutations in cyp51A gene, which confer azole resistance.~   "
16591|NCT03349801|"~     Development of novel clinical endpoints for interventional clinical trials with a regulatory~     and patient access intention in patients with intermediate age-related macular degeneration~     (AMD) - MACUSTAR~   "
16582|NCT03349918|"~     The exponential growth of physiological, behavioral and environmental data generated through~     consumer mobile health (mHealth) devices and Internet of Things (IoT) technology provide~     unprecedented sources of personalized and contextual health information. If linked to~     clinical health data from the Electronic Health Record (EHR), these data can provide dynamic~     and individualized views of patient health states and trajectories that can greatly inform~     clinical care and health-related research. The investigators propose to advance precision~     health through the development and evaluation of a mobile application and data platform that~     collects, harmonizes and integrates mHealth and environmental data from patients' daily lives~     with their clinical histories and electronic health record data.~      The investigators propose a participatory design approach to implement and evaluate a~     precision health platform through the study and modeling of hypertension (HTN) and depression~     in patient communities of UC Davis (UCD) and UC San Francisco (UCSF). These chronic diseases~     have high prevalence across geography, socioeconomic status, and race/ethnicity, and have~     significant economic, societal and personal costs. They are considerably challenging to~     manage due to difficulties in acquiring high-quality and consistent data from patients~     outside of their clinical care appointments that is so needed for a full view of the~     patient's disease state. Despite a broad array of self-monitoring devices and consumer~     applications, mHealth data are not getting into the clinical care process, and patients do~     not regularly monitor their own health states, particularly during periods of medication~     change, when frequent assessments are especially important.~      The investigators propose to conduct a 6-month single arm feasibility study of 200 ambulatory~     men and women (100 each at UCSF and UCD) with either hypertension or depression to implement~     an open, web-accessible, standards driven and patient-centric data platform for the~     integration of patient-reported and clinical data.~   "
16583|NCT03349905|"~     Controlled ovarian stimulation (COS) enhances the efficacy of ART (Assisted reproductive~     technology) by permitting multiple-oocyte yields, but also alters endometrial receptivity~     (ER) by an advancement of endometrial development which contributes to diminished pregnancy~     chances. Previous reports suggest that pregnancy rates are increased following deferred~     frozen embryo transfers. In addition as compared to fresh embryo transfers, frozen embryo~     transfers seem to be associated with less affected perinatal outcomes, in particular lower~     risk of preterm birth, small for gestational age and caesarean section. Unfortunately, most~     of the current evidence is based only on preliminary reports, needing further scientific~     evidence. Thus, whether differing embryo transfers could restore optimal ER leading to higher~     live birth rate (LBR) and better obstetrical outcomes as compared to fresh embryo transfers,~     is actually still under investigation.~   "
16584|NCT03349892|"~     Single arm, phase Ib/2a dose escalation study with an expansion cohort to determine the~     maximal tolerated dose (MTD) for stereotactic ablative radiotherapy of targets in the cardiac~     myocardium and to make a preliminary assessment of the efficacy of the treatment. The dose~     escalation will be guided by Time-to-Event Continual Reassessment Method (TITE-CRM) to ensure~     more patients will be spared dose limiting toxicities and more patients will be entered on~     the dose level that will be chosen as minimal dose of maximal effect. This design also allows~     for continual accrual of patients when delayed adverse events may be observed.~   "
16585|NCT03349879|"~     Vitamin D deficiency is a modifiable risk factor for poor bone health. Familial correlation~     of serum 25-hydroxyvitamin D concentration (25(OH)D) was reported in twin- or family-based~     studies, mostly from Caucasian parent-offspring pairs. However, data on the familial~     association of 25(OH)D in extended family structure and the relative contribution of genetic~     and shared environmental factors on serum 25(OH)D level are limited in Asian populations. In~     this study, the investigators aimed to assess the relative contribution of additive genetic~     and environmental components on serum 25(OH)D level by variance components method in a~     nationwide family-based cohort. Further, the investigators will evaluate the association of~     vitamin D status of index individual with prevalent vitamin D deficiency of each family~     member including spouse, offspring, sibling, and grand-offspring. Additive influences of~     paternal and maternal vitamin D status on offspring will be also investigated.~   "
16586|NCT03349866|"~     The purpose of this study is to assess the efficacy and safety of patients who receive~     concurrent neoadjuvant chemoradiotherapy for Siewert II ，III of locally advanced HER-2~     negative adenocarcinoma at gastroesophageal junction.~   "
16587|NCT03349853|"~     Acetaminophen is a drug commonly used in palliative care unit, for its antalgic and~     antipyretic effects. Several administration routes are possible but the use of the~     sub-cutaneous route is actually not supported by recommandations.~   "
16588|NCT03349840|"~     This is a study to be performed in Qatar that will look at the comparison of glycemic control~     in patients with type 2 diabetes on insulin glargine U100 with insulin degludec over the~     Ramadan period, to determine whether better glycemic control with fewer hypoglycemic episodes~     can be achieved.~   "
16589|NCT03349827|"~     The prognosis of patients with unresectable peritoneal metastases from gastric cancer is~     poor. These patients may obtain survival benefit from radical gastrectomy and cytoreductive~     surgery (CRS). The response rates of previous conversion therapy are low. Hyperthermic~     intraperitoneal chemoperfusion (HIPEC) and systemic chemotherapy are effective methods of~     reducing peritoneal cancer index (PCI) levels. Apatinib, a novel targeted inhibitor of VEGF~     receptor 2 (VEGFR2), shows significant antitumor activity in the patients with gastric~     cancer. The purpose of this study is to investigate the efficacy and safety of HIPEC and~     systemic chemotherapy combined with Apatinib in the conversion therapy of peritoneal~     metastases from gastric cancer.~   "
16590|NCT03349814|"~     Trial The aim of the study is to investigate which infectious diseases might mimic the~     symptoms of acute appendicitis to a degree to cause a diagnostic laparoscopy or laparoscopic~     appendectomy. The primary outcome is to compare the incidence of Yersinia spp. infection in~     patients, who undergo surgery due to suspected appendicitis, between those with and without~     appendicitis detected by polymerase chain reaction on rectal swabs. The secondary outcomes~     are comparison of the incidence of bacterial pathogens (Campylobacter spp., Salmonella spp.,~     Shigella spp., Aeromonas spp.) and Enterobius vermicularis in the two groups. Rectal swabs,~     appendix swabs, and blood samples are collected prospectively and research biobanks will be~     established. Initially, the rectal samples and serology samples will be investigated, and~     possible biomarkers and results of the appendix swabs will be evaluated at a later time~     point.~      Ethics The trial will be conducted according to the Helsinki II Declaration after approval~     from both the local Health Research Ethics Committee and the Danish Data Protection Agency.~     An informed written consent will be collected from the participants prior to inclusion in the~     study. Data will be stored according to the approval from the Danish Data Protection Agency.~     This study is conducted in patients with suspected appendicitis. These patients are fully~     awake and conscious at time of inclusion. The patients included in this study will not~     experience any adverse effects due to their participation.~   "
16592|NCT03349788|"~     Colorectal cancer is one of the most common tumors in Asia. According to the recent research,~     surgical procedure could provide more treatment benefit in rectal cancer. Therefore, it was~     consider that important to standardized and improved the surgical procedure for rectal~     cancer. With the development of anatomical technique, minimally surgery with laparoscopy had~     become the trend for surgical treatment. There were several studies has been done to evaluate~     the safety and feasibility of laparoscopic surgery. In order to achieve better surgical~     outcome and reduce operative complications, the investigators design stratified~     randomization, double blinded, muti - center clinical trail to investigate the value of left~     colic artery in laparoscopic radical rectectomy.~   "
16593|NCT03349775|"~     This study will investigate if metformin can help people with obesity and high pressures~     inside their lung blood vessels. Metformin is approved by the U.S. Food and Drug~     Administration (FDA) to treat diabetes, but metformin is not approved by the FDA to treat~     pulmonary hypertension.~      This study will examine whether Metformin will improve the high pressure inside lung blood~     vessels in people who are obese. The study will help understand the effect of metformin on~     pressures inside lung blood vessels.~   "
16594|NCT03349762|"~     To evaluate the efficacy and safety of Huaier granules for Prevention of Recurrence and~     Metastasis of colorectal cancer patients following radical surgery~   "
16595|NCT03349749|"~     Unwell patients in the intensive care unit (ICU) often need supplementary fluids to be given~     into the bloodstream through a drip in a vein (venous cannula), however too much fluid can be~     harmful. It can sometimes be difficult to tell whether or not a patient will benefit from~     extra fluids so they are given a fluid challenge, whereby a small volume of fluid is given~     quickly into the cannula and the change in their status is noted. If the patient's condition~     improves, this suggests that the patient is fluid responsive and needs more fluid.~      A LiDCOplus haemodynamic monitor is a device used in the ICU to estimate the amount of blood~     ejected from the heart on each heartbeat using pressure readings obtained from a tube placed~     in one of the patient's arteries (arterial line).~      The investigators aim to determine whether or not the use of this device called makes a~     difference to the judgement of fluid responsiveness when the patient is given a fluid~     challenge when compared to simply using measurements of pulse and blood pressure and~     assessing the circulation in the patient's limbs. This will allow the investigators to~     determine whether or not the LiDCOplus alters the decisions made by doctors and nurses about~     how much fluid to give their patients and hence if it is of any benefit.~   "
16596|NCT03349736|"~     To our knowledge, no studies in Nepal have reported the feasibility of performing the Pelvic~     Floor Muscle Training (PFMT) in Nepalese women. The aim of the study is to develop and~     implement a Pelvic Floor Muscle(PFM) physiotherapy program based on information, education~     and exercise in order to prevent or reduce Pelvic organ prolapse(POP) and Urinary~     Incontinence (UI) in pregnant Nepalese women~      The women will receive information (leaflet, video, posters) and instruction/guidance on PFM~     exercise. Following this, the women are advised to perform daily home PFM exercise Women will~     record their home PFM exercises using an exercise diary. Further, pre and post study design~     will be conducted to assess the change in PFM activation.~   "
16597|NCT03349723|"~     The primary objective of this trial is to investigate the safety and tolerability of BI~     1265162 in healthy male subjects following inhalative administration of single rising doses.~      Secondary objective is the exploration of the pharmacokinetics (PK) of BI 1265162 after~     single dosing.~   "
16598|NCT03349710|"~     This study has two, independent, cohorts, both in locally advanced squamous cell head and~     neck cancer. The purpose of the first cohort is to determine whether nivolumab in combination~     with radiotherapy is more effective than cetuximab in combination with radiotherapy, in~     subjects who are ineligible for cisplatin. The purpose of the second cohort is to determine~     whether nivolumab, cisplatin, and radiotherapy is more effective than cisplatin and~     radiotherapy in subjects who are eligible to receive cisplatin~   "
16599|NCT03349697|"~     This study is a randomized, double-blind, placebo controlled crossover study. The purpose of~     this study is to assess the ability of Phyllantus amarus to protect the liver against~     temporary stress including oxidative stress induced by alcohol consumption.~   "
16600|NCT03349684|"~     To demonstrate the efficacy and safety of acarbose and metformin loose-dose combination as~     compared to metformin monotherapy in the treatment of subjects with T2DM that is inadequately~     controlled by metformin alone~   "
16601|NCT03349671|"~     The main objectives of modern antenatal care programs are to identify high risk pregnancies~     then to predict any possibility of adverse pregnancy outcome as early as possible.~      The earliest attempts to achieve this goal were possible with the introduction of ultrasound~     in obstetrical practice in the 1950s. A breakthrough that enabled obstetricians to directly~     visualize the fetus, placenta and amniotic fluid. At first 2-dimensional (2D) imaging was~     employed whereby fetal biometry and placental location were detected. Later on, Doppler~     measurements & 3-dimensional (3D) representation became feasible further revolutionizing this~     area~   "
16602|NCT03349658|"~     The purpose of the study is to compare the effects of spinal and general anesthesia on~     transcranial regional cerebral oxygen saturation in geriatric patients undergoing total hip~     arthroplasty.~   "
16603|NCT03349645|"~     An Open Label Extension (OLE) study to assess the safety of long-term treatment with a 4 mL~     intra-articular injection of Ampion ™ in adults with pain due to severe osteoarthritis of the~     knee~   "
16604|NCT03349619|"~     Single-center, randomized, placebo-controlled study to investigate the effect of Resveratrol~     plus Carboxymethyl-β-Glucan, two sprays (100µL/spray) for nostril three times/day for 4~     weeks, in comparison with placebo, in reducing nasal interleukin-5 (IL-5) in children with~     Allergic Rhinitis (AR).~      Secondary objectives are to examine the effect of resveratrol plus carboxymethyl-β-glucan, in~     comparison with placebo, on subjective parameters, i.e. symptom scores, visual analogue~     scales for rhinitis, quality of life and quality of sleep, and the effect on objective~     parameters, i.e. nasal nitric oxide (nNO) levels, nasal cytology and acoustic rhinometry.~   "
16605|NCT03349606|"~     The goal of this study is to use [C-11]FLB 457 and amphetamine (oral, 0.5 mg/kg) to measure~     cortical dopamine transmission in cocaine dependent individuals and healthy controls~   "
25187|NCT03237325|"~     To assess the efficacy of SGX942 compared to placebo in decreasing the duration of severe~     oral mucositis in patients receiving chemoradiation treatment for the treatment of head and~     neck cancer~   "
16608|NCT03349567|"~     Antimicrobial resistance is one of today's most urgent public health problems. One of the~     most important strategies to slow the spread of antimicrobial resistance is the promotion of~     judicious antimicrobial use. There are tremendous opportunities to reduce unnecessary~     antimicrobial-prescribing, particularly in Emergency Departments (EDs). In this study, the~     investigators will work collaboratively with ED providers in the Veterans Health~     Administration (VHA) to reduce unnecessary antimicrobial use. Academic-detailing and an~     audit-and-feedback intervention will be implemented, and the study will assess how overall~     antimicrobial-prescribing changes once these interventions are performed. ED providers will~     be shown how their antimicrobial-prescribing compares to their peers, thereby encouraging~     them to consider their professional reputation when making prescribing decisions. To assess~     the impact of this intervention, the study will monitor providers' antimicrobial-prescribing~     behavior through an automated metric, i.e. number of antimicrobial prescriptions per number~     of patient-visits. To assess changes in the appropriateness of antimicrobial-prescribing, the~     study team will also perform manual chart reviews and compare prescribing decisions to~     published guidelines.~   "
16609|NCT03349554|"~     The aim of the study is to constitute a proof of concept study for a larger study~     investigating the effect of mindfulness on anxiety and agitation in Parkinson's disease (PD)~     based on the results of a preliminary feasibility.~   "
16610|NCT03349541|"~     Medical and technological advances have resulted in a growing cohort of children with medical~     complexity (CMC), many of whom would not have survived previously and are living and thriving~     within the community. These families have unique needs that have previously not been taught~     in the typical training programs for paediatricians. The goal of this project is to develop~     an evaluation of a national complex care curriculum and to identify whether dedicated~     educational modules have an impact on improving clinical performance and resident~     self-efficacy.~   "
16611|NCT03349528|"~     The purpose of this study is to determine if taking a probiotic supplement versus a placebo~     will reduce relapse and improve the clinical course among participants who have been~     hospitalized for bipolar depression.~   "
16612|NCT03349515|"~     Determine whether premedication with midazolam influences the effect of povidone-iodine~     ophthalmic prep solution on respiration in children undergoing strabismus surgery with~     general anesthesia.~      Hypothesis: Premedication with midazolam causes apnea after instillation of povidone-iodine~     solution into the eye~   "
16613|NCT03349502|"~     This study is a single center, single arm, open-labeled phase 2 clinical study. The aim of~     this study is to investigate the efficacy and safety of allogeneic natural killer cell~     (MG4101). After lymphodepletion with fludarabine and cyclophosphamide, the patient will~     receive MG4101. Each cycle consists of 28 days, and a total of 2 cycles of MG4101 will be~     administered with IL-2 to activate the study drug. The efficacy of MG4101 will be evaluated~     after 8 weeks from the first day of treatment. We will evaluate the safety of the drug~     measuring the vital sign, laboratory tests, and adverse events.~   "
16614|NCT03349489|"~     It has been reported that insulin basal rate reduction initiated at exercise onset can reduce~     the hypoglycemic risk during exercise. However, another potentially more efficient strategy~     to prevent exercise-induced hypoglycemia could be to reduce insulin basal rate a certain time~     prior to exercise. The objective of this study will be to compare the efficacy of two~     strategies to prevent exercise-induced hypoglycemia during a 60-minute exercise at moderate~     intensity: 1) reduce insulin basal rate 40 minutes prior to exercise; 2) reduce insulin basal~     rate 90 minutes prior to exercise.~   "
16615|NCT03349476|"~     This prospective, multicenter observational study will examine the ability of model based~     fast anatomical mapping (mFAM) to create left atrial (LA) geometry for atrial fibrillation~     ablation.~   "
16616|NCT03349463|"~     An important part of staging and deciding the method of treatment is knowing areas of how~     cancer is involved. Diagnostic imaging is often used to determine the location of the cancer~     using techniques like nuclear medicine, MRI (magnetic resonance imaging), CT (computerized~     tomography), and ultrasound. Each technique looks for cancer in different ways and are often~     used together to make a better determination of the extent of disease.~      One of the techniques used in cancer imaging is PET/CT. This technique combines a nuclear~     medicine study (PET or positron emission tomography) with CT performing both scans at the~     same time. PET/CT most commonly uses a radioactive sugar (FDG or fluorodeoxyglucose) to~     detect the cancer. The problem with FDG is that it is excreted by the kidneys and collected~     in the bladder. Even though the bladder is emptied prior to the scan, the FDG activity~     present there may interfere with the detection of small areas of cancer involvement in lymph~     nodes or adjacent areas. It is because of this that PET/CT using FDG is infrequently used in~     gynecological cancers.~      This purpose of this study is to evaluate if 18F-fluciclovine can be used to help determine~     the extent of gynecological cancers. 18F-fluciclovine (also known as AXUMIN) is a radioactive~     tracer which has been approved by the FDAFood and Drug Administration (FDA) for use in~     patients with prostate cancer. 18F-fluciclovine has much less excretion through the kidneys~     which improves the PET/CT imaging of the pelvis.~   "
16617|NCT03349450|"~     This is a Phase 2 non-randomized, open label, uncontrolled, efficacy and safety study. Study~     participants will receive two priming doses of 0.5mL of DPX-Survivac 21 days apart and up to~     six 0.1ml booster vaccinations every two months with low dose metronomic oral~     cyclophosphamide (50 mg BID) for one year or until disease progression, whichever occurs~     first.~      Pembrolizumab 200 mg will be administered every 3 weeks for up to one year or until disease~     progression, whichever occurs first.~   "
16618|NCT03349424|"~     This study is designed to assess the preventive effects of somatostatin on post-operation~     pancreatic fistula in intermediate risk patients after pancreaticoduodenectomy. Patients~     assigned into the treatment group will be continuous intravenous infusion with the~     somatostatin (Stilamin®) in addition to conventional treatments (including infection~     prevention, nutrition support and acid suppression therapy, etc.).The pancreatic fistula~     incidence will be monitored within 30 days after operation.~   "
16632|NCT03349242|"~     The rod-cone dystrophies (often referred to as retinitis pigmentosa (RP)) are a clinically~     and genetically heterogeneous group of disorders in which there is progressive loss of rod~     and later cone photoreceptor function leading to severe visual impairment. RP usually occurs~     as an isolated retinal disorder, but it may also be seen in association with systemic~     abnormalities.~   "
16619|NCT03349411|"~     The goal of this study is to understand what brain mechanisms become disrupted when stroke~     survivors experience delirium. Delirium is an acute reduction in attention and cognition,~     associated with poor recovery, longer hospitalization and even death. One major factor~     increasing the risk of delirium after stroke may be spatial neglect occurring after stroke on~     the right side of the brain. Spatial neglect affects awareness, orientation, and movement.~     The study will test the hypothesis that the right-dominant brain networks for arousal and~     attention are affected in both of these disorders. It is expected that the activity and~     structural integrity of these brain networks will correlate with behavioral signs and~     severity of delirium and spatial neglect. To test this hypothesis, the study will measure~     spatial neglect and delirium symptoms in 45 acute (NYC Health + Hospitals/Bellevue ) and 30~     subacute (Kessler Institute for Rehabilitation) stroke survivors and evaluate brain scans for~     these participants. This study may contribute to knowledge about brain bio-markers of~     delirium, which will greatly aid in delirium detection in stroke and other disorders.~   "
16620|NCT03349398|"~     Uncut Roux-en-Y vs Roux-en-Y reconstruction after distal gastrectomy for gastric cancer~   "
16621|NCT03349385|"~     The study will evaluate patients with, at least, one previous procedure of coronary~     revascularization (surgical, percutaneous or both), that are referred for a new, clinically~     indicated, diagnostic coronary angiography, to describe their clinical characteristics,~     management, and prognosis, and will propose a prognosis-oriented classification.~   "
16622|NCT03349372|"~     Allogeneic hematopoietic stem cell transplantation is the only possible treatment for many~     malignant and non-malignant hemopathies. The graft-versus-host immunological reaction (GvH)~     is a frequent and sometimes serious complication. The objective is to study whether a~     systematic and early follow-up by a lung specialist of allografted patients would allow an~     earlier diagnosis of GvH with pulmonary complications.~   "
16623|NCT03349359|"~     Background: Cytomegalovirus (CMV) infection is usually observed among patients with HIV~     infection. No study to date has investigated the impact of CMV infection on HIV viral load~     decay during antiretroviral therapy.~      Methods: 345 consecutive HIV patients coinfected (N=300) or not (N=45) with CMV were~     enrolled. Clinical, biological and virological data were collected from HIV antiretroviral~     therapy initiation to the day of HIV viral load undetectability if any.~   "
16624|NCT03349346|"~     The primary objectives of this study are to evaluate safety, tolerability, pharmacokinetics~     (PK) and preliminary efficacy of idelalisib; and to establish recommended phase 2 doses~     (RP2D) of idelalisib in combination with rituximab, ifosfamide, carboplatin, etoposide (RICE)~     in children and adolescents with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)~     or mediastinal B-cell lymphoma (MBCL)~   "
16625|NCT03349333|"~     This is a single arm, open-label, multi-center study designed to demonstrate the efficacy and~     safety of pralatrexate when administered concurrently with vitamin B12 and folic acid~     supplementation to patients with relapsed or refractory peripheral T-cell lymphoma(PTCL).~   "
16626|NCT03349320|"~     Pharmacological treatment of AD is currently based on cholinesterase inhibitors (ChEI) and~     memantine, which have been shown to lead to modest, although effective, clinical benefits.~     Donepezil is a ChEI metabolized through the cytochrome P (CYP) 450, primarily by the 3A4 and~     2D6 isoforms. The CYP2D6 gene presents polymorphisms that can alter its expression. The~     plasma therapeutic level ranges from 30 to 75 ng/mL, and 50% of acetylcholinesterase~     inhibition is achieved when the concentration reaches 15.6 ng/mL. An optimal plasma level is~     greater than 50 ng/mL.~      These polymorphisms may influence the individual's response to treatment with donepezil and~     the concentration of the drug in AD patients, without achieving the desired effect. However,~     most of the individuals are EM, i.e., the metabolism of the drug occurs according to the~     expected kinetics and is associated with the presence of one or two wild-type alleles.~      Objective: investigate the pattern of clinical response to donepezil in a group of patients~     with AD and AD with cerebrovascular disease (CVD) in relation to the plasmatic concentration~     of donepezil and polymorphisms of the CYP2D6 and apolipoprotein E (APOE) genes.~   "
16627|NCT03349307|"~     This study will determine the feasibility of the novel thin convex probe endobronchial~     ultrasound (TCP-EBUS) in human resected lobes. The primary end point is to clarify the~     feasibility of using the thin convex probe EBUS scope to visualize lung tumors from an~     intra-bronchial view. The secondary objective is to evaluate the insertion ability,~     operability, endoscopic image and ultrasound image compared to that of the convex probe EBUS.~   "
16628|NCT03349294|"~     Thyroid cancer patients who have undergone total thyroidectomy, postoperative iodine 131~     treatment to ablation residual thyroid tissue, is the current clinical practice. The~     effective half-life of the iodine 131 in the human body and in vivo exposure dose can be~     assessed by the in vivo kinetic model published by ICRP, but this model is based on standard~     healthy people and can not be corrected for patients undergoing total thyroidectomy.~      In this study, the investigators will use the actual clinical data to revise the biokinetic~     model of iodine-131 in patients with total thyroidectomy.~   "
16629|NCT03349281|"~     The investigators postulate that Pevonedistat will be effective in patients with~     relapsed/refractory acute lymphoblastic leukemia (ALL) when combined with a standard backbone~     ALL chemotherapy regimen.~   "
16630|NCT03349268|"~     The objective is to conduct a prospective, sham controlled, double-blinded, interventional~     crossover trial to compare standard terminal cleaning plus PX-UV (intervention) with standard~     terminal cleaning plus sham PX-UV (control) with crossover at 12 months, following a 6-month~     washout period. Outcome measures include the rates of HAIs, as well as the recurrence of~     genetically identical clinical strains of HAIs among patients on study units. The study will~     be conducted in 2 hospitals covering 16 total hospital units at Detroit Medical Center. Our~     central hypothesis is that the addition of PX-UV to standard terminal cleaning will be~     associated with a significant reduction in the rate of HAIs, as well as a reduction in the~     recovery of genetically identical strains of MDROs. The impact of PX-UV disinfection on rates~     of HAIs on study units will be determined by comparing rates of HAIs on a) study units where~     PX-UV is added to standard terminal cleaning practices to b) units where a sham UV~     disinfection system is added to standard terminal cleaning; and by comparing rates of HAIs on~     the same medical ward during each of two 12-month phases of a crossover study (one phase when~     a PX-UV device is added and one when a sham device is added to standard terminal cleaning).~      The long-term goal of this project is to establish the efficacy of terminal cleaning plus~     PX-UV in reducing rates of HAIs due to the following multi-drug resistant organisms (MDROs):~     C. difficile, vancomycin-resistant enterococci (VRE), Klebsiella pneumoniae and Escherichia~     coli producing extended-spectrum beta-lactamases (ESBLs), methicillin-resistant~     Staphylococcus aureus (MRSA) and Acinetobacter baumannii.~      At the conclusion of the proposed project, novel data will be generated from this rigorously~     controlled study regarding the effectiveness of PX-UV in reducing HAIs in a representative,~     real-world healthcare setting.~   "
16631|NCT03349255|"~     Clinical study to evaluate safety and pharmacokinetics (primary objectives) and efficacy~     (secondary objective) of ET1402L1-CART-cells in patients with AFP+ HCC~   "
16633|NCT03349229|"~     As the french population is ageing, the question of medical care in elderly cancer patients~     is fundamental. A third of all cancer patients are 70 years or older. This population has~     specific challenges: autonomy maintenance, treatments efficacy with limited side effects.~      As a result of a call to projects, the Geriatric Oncology unit of the French Alps (UCOGAlp)~     has been selected by the National Institute of Cancer (INCa). It includes 15 centres in the~     Alpine area. This unit has been evaluated patients since 2011, giving them a full geriatric~     evaluation and trying to establish adapted cares.~      In order to evaluate the impact of those evaluation on patients' health, the investigators~     have developped a geriatric follow-up after 1 month (D30) and 4 months (D120).~      The investigators want to develop a common data base to these centres, in order to evaluate~     the care practices that were developped, and demonstrate the benefit for the patient on the~     dependence level and the overall survival.~   "
16634|NCT03349216|"~     Background: There are three methods for procedural sedation in upper extremity traumas;~     systemic, regional and local anesthesia. There is controversy in the literature regarding the~     method of choice for this purpose.~      Objectives: The aim of this study was to compare conscious sedation and Bier's block methods~     for pain reduction in upper extremity trauma patients.~      Patients and Methods: This was a randomized clinical trial. Patients were randomly allocated~     to either the Bier's block or the conscious sedation group. Pain reduction was assessed by a~     numerical rating scale; patients, surgeons and physicians responsible for analgesia~     satisfaction were assessed using a five-point Likert scale.~      In this study, we aimed to compare the effectiveness, complications, duration, hemodynamic~     stability and patient and physician satisfaction between systemic analgesia and Bier's block~     method performed at the emergency department.~   "
16635|NCT03349203|"~     The main purpose of this study is to evaluate the pulmonary and metastases lesions objective~     response rate after Icotinib preoperative therapy in EGFR-mutant stage IIIB or~     oligometastasis Non-small Cell Lung Cancer which can be potentially radical treated by~     surgery.~   "
16636|NCT03349190|"~     Fibroid is a frequent pathology of infertile women. Its deleterious effect on the infertility~     would be due to the mechanical way.~      The interest of the resection of intramural fibroids is discussed. It is necessary to measure~     the indication of a myomectomy, whatever the surgical procedure. On the one hand, it may~     cause important potential complications, and on the other hand, the surgery does not improve~     the parameters of the fertility.~      Thus, it is a major stake to avoid the surgical operation. A decrease of the size of these~     fibroids by medical treatment is then a good option.~      When the surgical treatment is necessary, a medical pre-surgical treatment is often proposed~     in order to decrease the symptomatology and to reduce the size of the fibroid to facilitate~     the surgery.~      Acetate Ulipristal (UPA) has been marketed in this indication. Following the Pearl I-II~     studies, the first indication in France was a pre-surgical treatment for 3 months at a dose~     of 5 mg per day.~      The Pearl III and IV studies evaluated the Esmya® administration as a long-term intermittent~     repeated treatment, giving to it a prominent position for the long-term management of~     symptomatic fibroids.~      Furthermore, cases of pregnancy before surgery are frequently described in women with~     fibroids treated by UPA for a pre-IVF surgery.~      5 to 10 % of women who are managed for infertility have fibroids and only 2% to 3% have this~     unique cause of infertility.~      Then, some of patients followed in ART centers have been treated by UPA to reduce the~     fibroids size and/or to decrease the associate symptoms.~      The aim of this study is to evaluate in the different French ART centers, the impact on~     fertilization of UPA administration for infertile women with fibroids and to describe the~     modalities of its prescriptions and to collect information regarding safety tolerance profile~     of Esmya® in this patient population.~   "
16637|NCT03349177|"~     Neoadjuvant chemotherapy (NAC) has become the standard therapy for both locally advanced and~     early-stage breast cancer in recent years for the improvement breast conserving surgery rate~     and the evaluation of treatment response in vivo. Pathological complete response (pCR) is an~     independent prognostic factor irrespective of breast cancer intrinsic subtypes after NAC. The~     trial is designed to compare effectiveness between anthracycline and/or taxane as neoadjuvant~     chemotherapy for operable advanced breast cancer in different molecular typing. In this trial~     the investigators will randomly assign 200 primary breast cancer patients to receive six~     cycles of fluorourcil, epirubicin,and cyclophosphamide(FEC), or four cycles of epirubicin and~     cyclophosphamide (EC) followed by four cycles of docetaxel(T), or six cycles of docetaxel and~     cyclophosphamide (TC). Trasuzumab was recommended combining docetaxel to patients if HER-2~     positive.The effectiveness of therapy will be estimated after every two cycles of neoadjuvant~     chemotherapy. Surgery will be performed after completing designated full cycles of~     neoadjuvant chemotherapy. The primary endpoint is to assess pathologic complete response~     (pCR, ypT0/is ypN0) rate in different regiments. The secondary endpoint is to assess the~     relationship between pCR rate with molecular typing in different regiments, so that the~     investigators could optimize neoadjuvant chemotherapy regiment according to molecular typing.~   "
16638|NCT03349164|"~     There will be assessment of patients after acute pulmonary embolism for the development of~     CTEPH~   "
16639|NCT03349151|"~     To compare early versus on demand maternal feeding after cesarean delivery regarding~     gastrointestinal complaints and patient's satisfaction.~   "
16640|NCT03349138|"~     This study evaulates the addition to the standard theraphy of enriched sensorimotor training~     by means of robotic glove therapy, or functional electrical stimulation in the treatment of~     chronic stroke patients with upper limb motor impairments. All the patients receive the~     conventional physiotherapic treatment. Supplemental to the conventional treatment, patients~     are evenly split in four groups to provide different treatments for an equivalent amount of~     time. Patient in the first group receive supplemental conventional therapy; patients in the~     second group receive robotic glove therapy; patients in the third group receive functional~     electrical stimulation; patients in the fourth group receive robotic glove treatment and~     functional electrical stimulation in different sessions.~   "
16641|NCT03349125|"~     The purpose of this study is to characterize oral-pharyngeal swallow function with the~     guidance of videofluoroscopy under two conditions, with and without cervical bracing, in~     patients determined to have dysphagia.~   "
16642|NCT03349112|"~     The purpose of this study is to determine whether subjects report a difference in comfort~     with High Resolution Pharyngeal Manometry (HRPM) conducted following application of lidocaine~     as an anesthetic as compared to HRPM conducted without anesthetic.~   "
16643|NCT03349099|"~     The purpose of this study is to assess whether one of two ureteral access sheaths is safer~     for patients undergoing ureteroscopy. Both sheaths are FDA approved devices and commercially~     available. The investigators will compare the ability of sheaths to access the kidney through~     the ureter and will compare damage done to the ureter after completion of the procedure.~     Access sheaths are standard of care for this procedure; this study seeks to optimize outcomes~     for patients.~      Patients undergoing ureteroscopy who do not have ureteral stents in place and who have not~     had an ipsilateral procedure within 90 days will be recruited and consented.~   "
16645|NCT03349073|"~     T-1101 is a novel anti-cancer agent being developed by Taivex Therapeutics Corporation, and~     is being studied in a phase I dose escalation trial, protocol TAI-001. That trial's primary~     aim is to study the safety and tolerability of T-1101 (Tosylate) in subjects with advanced~     refractory solid tumors, and provides for a maximum of 2 cycles of treatment. At the end of 2~     cycles of treatment, it is likely that some patients will be continuing to receive clinical~     benefit from T-1101 (Tosylate). The intention of this program is to enable these patients to~     continue to receive T-1101 (Tosylate) at the discretion of the principal investigators and~     Taivex Therapeutics Corporation.~   "
16646|NCT03349060|"~     B7451012 is a Phase 3 study to evaluate PF-04965842 in patients aged 12 years and older with~     a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. The efficacy~     and safety of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily,~     will be evaluated relative to placebo over 12 weeks of study participation. Eligible patients~     will have an option to enter a long-term extension study after completing 12 weeks of~     treatment.~   "
16647|NCT03349047|"~     Living with food allergy may result in anxiety and reduced quality of life. Food allergic~     patients and their families are often concerned about casual exposure with the offending~     allergen through skin contact or being near the offending food, which is actually very low~     risk. This concern can limit social activities and increase stress. The aim of this study is~     to provide a behavioral intervention consisting of having peanut/tree nut allergic patients~     hold a cup with a peanut or tree nut to which the patient is allergic to and touching it. The~     goal is to reduce anxiety about casual exposure to food allergens and improve quality of life~     for patients with food allergies and their families.~   "
16648|NCT03349034|"~     Head and neck oncologic surgery often requires the use of free tissue transfer, or~     microvascular reconstruction, to reconstruct defects created by tumor resections. Although~     there are several techniques for the reconstruction of defects, resection of large tumors~     leave defects that require the transfer of vascularized tissue from one part of the body to~     repair the defect. For example, the removal of a segment of diseased mandible requires free~     tissue transfer containing the component parts - skin, muscle, and bone - to reconstruct the~     deficit created by the resection of the tumor. Over the years, microvascular surgeons have~     focused their attention on maximizing the success of these technically difficult surgeries.~     However, now, with free flap reconstruction rates in excess of 95%, surgeons are afforded the~     opportunity to turn their focus toward the morbidities associated with these surgeries. While~     much has been published about donor site wound healing, pain control in the post-operative~     period has largely been neglected in the head and neck reconstruction literature. Systemic~     analgesia with opioids is standard of care, which has been shown to lead to increased~     confusion, significantly increased length of stay and increased risk of pulmonary~     complications. In addition, it has been shown that early mobilization and optimal wound care~     can decrease donor site morbidity.~      In this study the clinical team aims to better control donor site pain utilizing local,~     targeted analgesia to relieve pain at the donor site for osseocutaneous free-flaps. To reduce~     confounding and bias, the study will be a double-blind prospective randomized placebo~     controlled trial wherein patients undergoing osseocutaneous free flap surgery will be~     randomized to receive continuous infusion of ropivacaine or normal saline (placebo) via local~     continuous infusion catheter, which will be placed intraoperatively at the time of donor site~     closure. Patients' pain will be monitored for the first 48hrs after surgery. Donor site and~     global pain at rest will be evaluated every 8 hours for the first two postoperative days~     using a visual analogue pain scale (VAS). Essentially, there is a 100 millimeter line drawn~     on a piece of paper, with no pain marking the left end of the line and worst pain marking~     the right end of the line. Subjects mark with a pen along the line where pain is felt fits~     along that continuum. A researcher then measures how far along the line that mark is placed~     and then it is recorded. Median daily opiate use via PCA will also be tracked. Donor~     site-specific range of motion and strength will be assessed with a formal physical therapy~     evaluation on post-operative day 2 or soonest non-holiday weekday. Information on patient~     satisfaction, time to ambulation, and length of stay will also be collected. Subgroup~     analysis will be performed.~   "
16649|NCT03349021|"~     Feasibility testing of a cap-assisted endoscopic bougienage for benign upper GI stenosis with~     direct optical control.~   "
16650|NCT03349008|"~     This study evaluates the addition of glycyrrhizin to entecavir in the treatment of patients~     with chronic hepatitis B in China. Half of participants will receive magnesium~     isoglycyrrhizinate followed by oral diammonium glycyrrhizinate and entecavir in combination,~     while the other half will receive a placebo and entecavir.~   "
16651|NCT03348982|"~     This study aims to investigate whether physical activity intervention would be effective to~     improve sleep quality in children with ASD, and investigate how physical activity impacts on~     sleep in children with ASD through melatonin-mediated mechanism model. A parallel-group~     randomized controlled trial comparing a 12-week jogging intervention and a control group~     receiving standard care in 32 children with ASD will be conducted. This study will monitor~     the changes of four sleep parameters (sleep onset latency; sleep efficiency, wake after sleep~     onset and sleep duration) through objective actigraphic assessment and parental sleep logs.~   "
16652|NCT03348969|"~     To investigate the ability to predict chemo-response in patients with recurrent non-muscle~     invasive bladder cancer (NMIBC).~   "
16653|NCT03348956|"~     This pilot study will attempt to establish the feasibility of using tissue oxygen~     measurements as a potential biomarker for chemotherapy-induced peripheral neuropathy (CIPN).~     Thirty (30) subjects scheduled to begin taxane-based chemotherapy for breast tumor will be~     assigned to receive an India ink injection under the skin of the foot. The ink will be used~     to make up to five (5) 45-minute electron paramagnetic resonance (EPR) oximetry readings~     prior to the start of chemotherapy. Subjects will undergo electrophysiologic assessments~     including electromyography and nerve conduction studies, in addition to a neurological~     examination prior to the start of chemotherapy. Subjects will have the EPR oximetry readings,~     electrophysiologic tests, and neurological examination two more times: at the halfway point~     of their chemotherapy treatment -- or at the onset of CIPN symptoms -- and again after~     chemotherapy has been completed.~   "
16654|NCT03348943|"~     Cerebral Palsy (CP) is a group of permanent disorders that affect movement and posture due to~     a non-progressive lesion in the immature brain occurring in fetal brain development or in~     infancy. These disorders are often associated with changes in sensation, learning, body~     perception, communication and behavior. People with CP present variable difficulties in~     muscle action. With increasing access to computer-aided accessibility, rehabilitation~     programs have increasingly used virtual reality (VR) environments to provide functional~     tasks. Virtual reality research in individuals with cerebral palsy has demonstrated~     improvements in gross motor functions and functional disabilities in mobility, and is a good~     device for rehabilitation. The present research is a cross-sectional study. For this study 40~     individuals aged over six years (with task comprehension) of both gender who have a clinical~     diagnosis of spastic hemiparetic Cerebral Palsy will be evaluated. Thus, the present study~     aims to compare the motor function of the committed and uncommitted body side by performing~     tasks in virtual reality.~   "
16655|NCT03348930|"~     The proposed study will consist of a 5-week double-blind cross-over study trial of tolcapone~     in 20 people (ages 18-65). The study will be divided into an initial 2 week phase and a~     second 2 week phase, with one of the 2 week phases consisting of active treatment with~     tolcapone, and the other 2 week phase consisting of inactive placebo treatment. There will be~     a one-week wash-out phase between the 2-week treatment phases. Participants will be~     randomized to receive either tolcapone or placebo during the first 2 week phase on a 1:1~     basis. This blinding will be maintained by the IDS pharmacy at the University of Chicago.~   "
16656|NCT03348917|"~     This study determines the effects of a single application of different antiseptic skin~     cleansers on the composition of the skin surface microbiome using next-generation sequencing~     (NGS) techniques. Twelve healthy volunteers will receive all three test products in a~     randomized order to compare the effects of each skin cleanser.~   "
16657|NCT03348904|"~     The purpose of this study is to evaluate the efficacy and safety of the combination of~     nivolumab plus epacadostat in combination with platinum chemotherapy compared with platinum~     chemotherapy alone, in participants with treatment-naïve Stage 4 or recurrent non-small cell~     lung cancer (NSCLC).~   "
16658|NCT03348891|"~     This trial is a translational proof-of-concept, open-label, prospective cohort study of 60~     patients aiming to identify the clinical markers and/or biomarkers associated with~     therapeutic response to immune checkpoints inhibitors, in patients with advanced melanoma.~      The study will be conducted on a population of patients treated with ICI in the context of~     routine care, separated in two subgroups:~        -  Subgroup 1: patients treated with anti-PD-1 alone (nivolumab or pembrolizumab)~        -  Subgroup 2: patients treated with the combined treatment anti-PD-1+anti-CTLA-4~          (nivolumab + ipilimumab)~      For each included patient, tumor biopsy specimens and blood samples will be collected during~     baseline visit and during treatment period (at Week 6 Day 1 and Week 12 Day 1).~      All included patients will be followed-up for tumor status and/or survival status every 3~     months until a maximum duration of 1 year from the first study dose.~   "
16659|NCT03348878|"~     Therapeutic compliance is defined as the degree of coincidence between a person's behavior~     and prescribing advice given by his or her physician. According to the World Health~     Organization (WHO), insufficient adherence is the main reason why patients do not get all~     the benefits they could expect from their medicines. It causes medical and psychosocial~     complications, diminishes the quality of life of patients, increases the likelihood of drug~     resistance, and waste of resources.  In the case of certain conditions such as high blood~     pressure (hypertension), poor adherence increases the risk of stroke, acute coronary~     syndrome, and heart failure.~      In patients with uncontrolled hypertension under treatment, the issue of therapeutic~     non-compliance should always be considered before considering the dose (supplemental drug) of~     antihypertensive therapy.~      For each patient participating in the study, medication adherence (for one of the~     antihypertensive treatments) will be assessed for 2 months using an electronic pill. The~     antihypertensive treatments considered for the study belong to the following classes:~     diuretics, beta-blockers, calcium-blockers, ACE (angiotensin-converting enzyme) inhibitors,~     sartans.~      Main objective: care objective: to provide physicians and patients with assistance in case of~     ineffectiveness or therapeutic escape in a chronic disease such as hypertension, by assessing~     the compliance profile of each patient.~      Secondary objectives: to carry out a quantitative typology of drug adherence in patients with~     unbalanced HTA under treatment.~   "
16660|NCT03348865|"~     Research Objectives:~        1. To test the FeLiCiA, a 6 week intervention developed for the management of psychological~          morbidities associated with infertility, using external randomised control trial~          methods, on patients showing positive indicators for psychological morbidity amongst~          patients with infertility at UCH Ibadan, Nigeria.~        2. To explore and understand patient perspectives on the benefits of the FeLiCiA~          counselling in addition to usual clinical care.~      Summary of Research:~      Population:~      Sample size N=42 Men & Women (aged 21-45) with GHQ 12 score indicative of mild to moderate~     psychological morbidities (3 or more) among patients attending University College Hospital~     for infertility treatment.~      Intervention:~      FELICIA [N= 21 intervention] 6 weekly counselling Follow up at 6/52 and 6/12. Inclusion~     Criteria: Age 21-45; Exclusion Criteria: Previously diagnosed mental illness; severe anxiety~     & depression or suicide intent (immediate referral); Age<21/>45.~      Comparison: [N=21 control group] Treatment as usual~      Outcome:~      Primary-GHQ12 score less than 3 Secondary-~        1. Sustained GHQ12 score less than 3~        2. Patient perspectives on benefits and effectiveness of intervention, and patient~          empowerment post intervention.~   "
16661|NCT03348852|"~     In the study the investigators aim to test whether transcranial direct current stimulation~     (tDCS)-induced pain reduction is in association with functional changes in the brain measured~     with functional magnetic resonance imaging (fMRI) in patients with chronic inflammatory bowel~     diseases (IBD).~      Hypothesis: Transcranial direct current stimulation can reduce the perception of pain in~     patients with chronic inflammatory bowel diseases, which is in association with changes in~     the brain measured via fMRI.~   "
16662|NCT03348839|"~     This medico-economic research project (PRME) aim to analyse NeLLY service efficiency for not~     on dialysis severe chronic kidney disease (DFG < 30ml/mn) patients care. NeLLY is a service~     that includes telemonitoring, educational therapy and support for patients with severe~     chronic kidney disease.~   "
16663|NCT03348826|"~     This is a study looking at the use of sodium bicarbonate to restore the flow of blocked~     central line devices in patients with blood cancers.~      Central line devices uses thin tubes that are placed into a vein in the body to give~     medicines, fluids, nutrients, blood products, etc.~      Sometimes, the lines become blocked. The standard procedure to get the line working again is~     to use alteplase, a protein that dissolves blood clots. While blood clotting is one cause of~     a blocked line, other reasons included the formation of calcium deposits. Sodium bicarbonate~     is routinely used in the treatment of patients receiving chemotherapy. Sodium bicarbonate is~     a liquid drug which is capable of dissolving protein and calcium deposits.~      This study will compare whether sodium bicarbonate works just as well as alteplase to recover~     the function of a blocked line.~   "
18200|NCT03328689|"~     The primary objective of this study is to compare the effectiveness and cost-effectiveness of~     an individualized group based exercise and education program supported in the community to a~     control group of usual care in preventing back pain flare-ups and to mitigate the negative~     consequences of subsequent episodes if they occur.~   "
16664|NCT03348813|"~     Despite advances in HIV/sexually transmitted infection (STI) prevention, Black youth account~     for the largest number of new HIV infections among heterosexual youth. Having a mental~     illness contributes to HIV/STI risk among heterosexually active Black youth, as some use sex~     as a means to manage psychological distress, regulate emotions and receive validation or~     acceptance. Current intervention models focus on cognitive-behavioral strategies to reduce~     risk among adolescents; however, these approaches in isolation do not address the~     psychopathology that further potentiates risk behaviors among adolescents with mental~     illnesses. This randomized controlled trial evaluated the effects of Project GOLD, a~     theoretically-driven, gender and culturally relevant, developmentally and psychologically~     appropriate HIV/STI risk reduction intervention on the sexual behaviors of Black male and~     female adolescents in Philadelphia (aged 14-17). In addition to evidence-based HIV/STI~     preventions strategies (e.g., role playing), Project GOLD includes unique emotion regulation~     content to address the relationship between psychological distress and HIV/STI risk~     behaviors.~      The research team approached and screened 704 adolescents. Eighty-two participated in the~     elicitation research activities (e.g., focus groups, intervention dress rehearsal). Another~     173 underwent a structured demographic and mental health diagnostic interview to determine~     RCT eligibility. Project GOLD was then tested with 108 Black youth in comparison to a general~     health promotion control condition (intervention n = 52; control n = 56). Youth who were not~     in psychiatric treatment were also included, as the investigators hypothesized that they~     would also benefit from the targeted psychoeducational content; post-hoc analyses examined~     differences in the intervention effects based on whether or not youth were in psychiatric~     treatment. The intervention had high feasibility and acceptability. These findings underscore~     the need to encourage HIV/STI testing and risk reduction efforts among Black youth, including~     those with mental illnesses.~   "
16665|NCT03348800|"~     The aim of this single-blind split-mouth study is to compare traditional syringe technique~     versus computer-controlled Wand® anesthetic System to evaluate pain perception, assessed with~     Visual Numerical Rating Scale, and heart rate in children requiring at least two tooth~     extractions on opposite sides of the maxilla. The investigators suppose that the feeling of~     fear during anesthesia administration is related to the use of the conventional syringe and~     that the pain to the lack of control of the plunger of the syringe.~      The computer-controlled delivery system allows the operator to hide the needle and to control~     the pressure exerted during anesthetic administration.~   "
16666|NCT03348787|"~     The present study wants to evaluate the efficacy of a short psychoeducational type group~     intervention and Cognitive behavioral therapy (CBT) 3rd wave on the severity of hallucinatory~     Acoustico-Verbal (HAV) symptomatology in patients with schizophrenia.~   "
16667|NCT03348774|"~     SLE disease course is characterized by unpredictable relapses and remissions in the majority~     of patients. However, in a small proportion (approximately 5%), SLE presents with a~     monophasic pattern, meaning that these patients have active disease before and immediately~     after diagnosis and after some time they achieve prolonged remission (for 12 years on~     average). Interestingly, about half of these patients do so and require no medications. On~     the other end of the clinical spectrum, approximately 50% of the patients demonstrate~     persistent disease activity and usually have the highest risk for developing co-morbidities~     and irreversible damage. A major goal of clinical research in SLE is to improve disease~     management based on disease course. By better characterizing SLE disease course we hope to~     better identify patients early in the disease course for targeted therapies to prevent and or~     reduce future SLE complications.~      The overall objective of our project is to define distinct phenotypes of SLE based on disease~     course, clinical features, pathogenic mechanisms, genetic factors and relevant biomarkers.~   "
16668|NCT03348761|"~     Background:~      Previous studies on network mechanism of repetitive transcranial magnetic stimulation (rTMS)~     suggest that pre-treatment resting-state fMRI (rs-fMRI) connectivity between left~     dorsolateral prefrontal cortex (lDLPFC) and subgenual anterior cingulate cortex (sgACC) might~     serve as predictive biomarker for antidepressant treatment response, although direct evidence~     is still lacking. Furthermore, the time course of symptomatic change to explain~     inter-individual differences in treatment prediction models has been largely ignored.~     Therefore, the aim of this study is to directly investigate the predictive role of~     lDLPFC-sgACC rs-fMRI connectivity on rTMS treatment response trajectories (time-dependent~     changes in depressive symptom scores) in treatment-refractory depression.~      Methods:~      Rs-fMRI data are collected from treatment-refractory depressed patients before undergoing 20~     sessions of 10 Hz lDLPFC neuronavigation rTMS over 4 weeks. Primary outcome measure is~     time-dependent change (trajectory) in depressive symptom scores measured with~     Montgomery-asberg Depression Rating Scale at baseline, week 2, 4, 6, 8, and 12.~      Multiple regression with backward elimination is used to investigate predictors of treatment~     response at week 12. Symptom score trajectories are analyzed using growth curve analysis.~   "
16669|NCT03348748|"~     This pilot clinical trial studies the effects of stereotactic body radiation therapy followed~     by surgery in treating patients with stage I-IIIA non-small cell lung cancer. Stereotactic~     body radiation therapy is a method of radiation that uses imaging to precisely locate a tumor~     and then deliver very high radiation doses to the tumor site in order to limit normal tissue~     toxicity or damage.~   "
16670|NCT03348735|"~     Evaluation of topical treatment with lidocaine 5% patch (daily administration) or capsaicin~     8% patch (periodic administration - upon reoccurrence of pain symptoms) in adult patients~     suffering from localized neuropathic pain (LNP) across a wide variety of etiologies, with a~     duration between 1 and 12 months (subacute to chronic neuropathic pain (NP)).~   "
16671|NCT03348722|"~     The purpose of the START project is to evaluate the acceptability, the safety and the~     cost-effectiveness of a population based program of active surveillance for patients newly~     diagnosed with a localized, low risk, prostate cancer.~   "
16672|NCT03348709|"~     This double-blinded, active comparator, cross-over intervention study tested the impact of~     two different oral supplements on ileostomy output volume and urinary sodium excretion and~     intestinal aquaporin expression in eight compensated patients with an ileostomy and not on~     home parenteral Nutrition or fluid support.~   "
16673|NCT03348696|"~     The REaCT TAPS clinical trial will compare a tapering dose of dexamethasone to other~     standards of care on the presence of taxane-associated pain syndrome (TAPS) in early stage~     breast cancer.~   "
16674|NCT03348683|"~     A randomized, prospective trial will be offered to women admitted to the labor floors at~     Mount Sinai Medical Center for labor induction.~   "
16718|NCT03348111|"~     Considering the frequent occurence of peri-implantitis and mucositis, a multiple of treatment~     alternatives have been proposed including non-surgical and surgical procedures. However, it~     seems that the most effective treatment remains prevention of these diseases.~      The aim of this study is to emphasize on mucositis and peri-implantitis prevention using an~     air abrasion device the Air-Flow Master Piezon® with erythritol and chlorhexidine powder in~     order to eliminate and / or disorganize the biofilm responsible for peri-implant mucosa~     inflammation.~   "
16675|NCT03348670|"~     -  Correlate Topoisomerase II Gene Single Nucleotide Polymorphisms (SNPs) to Using~          Etoposide Therapeutic Effects of Treating Small Cell Lung Cancer (SCLC)~        -  Correlate CYP450 3A4 Gene Single Nucleotide Polymorphisms (SNPs) to Using Etoposide Side~          Effects of Treating Small Cell Lung Cancer (SCLC)~        -  Correlate Dihydrofolic-Acid Reductase Gene Single Nucleotide Polymorphisms (SNPs) to~          Using Methotrexate Therapeutic Effects of Treating Small Cell Lung Cancer (SCLC)~        -  Correlate Dihydrofolate Reductase Gene Single Nucleotide Polymorphisms (SNPs) to Using~          Methotrexate Side Effects of Treating Small Cell Lung Cancer (SCLC)~        -  Correlate Thymidylate Synthetase Gene Single Nucleotide Polymorphisms (SNPs) to Using~          Methotrexate Side Effects of Treating Small Cell Lung Cancer (SCLC)~   "
16676|NCT03348657|"~     Music therapy has long been used to improve communication, health and quality of life. Music~     is also known to regulate pain, mood and anxiety levels. In the geriatric population, music~     listening has been shown to decrease depressive symptoms and neuropsychiatric symptoms such~     as agitation and anxiety. As a result, the use of music is recommended by national guidelines~     to control the behavioural symptoms of patients in long-term care facilities. Despite the~     demonstrated positive benefits of music for health and behavioural outcomes, very few studies~     using music have been performed in the hospital environment and even fewer on short-stay~     geriatric units.~      Older adults are the fastest-growing group of patients admitted to hospital, and the~     age-related burden of non-fatal health outcomes is one of the main challenges faced by~     hospitals. One of those age-related burdens is related to falls. Falls are highly frequent in~     geriatric patients, particularly on short-stay geriatric units, with a prevalence of up to 30~     %. Falls are associated with increased length of hospital stay, high health-care costs and~     negative non-fatal health outcomes including multi-morbidities and related disabilities.~      Previous research has shown that music may decrease the risk of falls. For example, it was~     shown that the rhythm of music, combined with physical exercise, can improve measures of gait~     stability. In older community dwellers, music-based programs have demonstrated that~     improvement of gait stability decreased the risk of falls. We therefore hypothesized that~     music listening may decrease the risk of falls of geriatric patients admitted to a short stay~     unit.~      This study aimed to examine the influence of music listening on the risk of falls in patients~     admitted to a Geriatric Assessment Unit (GAU) by comparing the Morse Fall Scale (MFS) score~     for patients who attended music listening sessions and in control patients who did not attend~     these music sessions. To our knowledge, this is the first study to assess the effect of music~     listening on the risk of falls in a geriatric unit.~   "
16677|NCT03348644|"~     The aim of this study was to investigate the feasibility and efficacy of a high intake of~     milk and/or cheese products compared to phosphate tablets in patients with hypophosphatemic~     rickets when evaluating the S-phosphate levels as a main effect parameter. The study was~     designed as a randomized, multiple crossover study.~   "
16678|NCT03348631|"~     This phase II trial studies how well tazemetostat works in treating patients with ovarian,~     primary peritoneal, or endometrial cancer that has come back. Drugs used in chemotherapy,~     such as tazemetostat, work in different ways to stop the growth of tumor cells, either by~     killing the cells, by stopping them from dividing, or by stopping them from spreading.~   "
16679|NCT03348618|"~     This study will evaluate the use of intravenous immunoglobulins (IVIG) at a dose of~     1g/Kg/body weight given every three weeks for 6 infusions in pediatric subjects ages 4 - 16~     years with moderate to severe PANS. The study will compare biomarkers and behavioral scales~     before treatment, after the last infusion, and 2 months after treatment.~   "
16680|NCT03348605|"~     It has been observed that patients subjected to amputations develop so called receptive~     fields, which time of occurrence and localization over time are yet not examined~     systematically.~      This clinical trial aims to investigate the reliability in detecting these receptive fields~     as well as their incidence and changes over time.~      Further it aims to evaluate the acute effect of a stimulating system (Phantom Stimulator~     (Cort X Sensorics, Spaichingen, Germany)) on selected gait parameters measured tough a gait~     analysis system (OprtoGait (Microgate, Bolzano, Italy)) as well as on phantom sensations~     measured through a questionnaire.~   "
16681|NCT03348592|"~     The purpose of this Phase 1, 3-period crossover with repeated measures feasibility study is~     to characterize the gut microbiome of individuals with chronic kidney disease, and to explore~     effects of p-inulin on the gut microbiome. The nature of the study will provide information~     about the feasibility of stool sample collection for future multicenter studies of the gut~     microbiome.~   "
16682|NCT03348579|"~     Hospital-acquired pneumonia are a common disease in intensive care unit. The prevention, the~     diagnosis and the treatment of hospital acquired pneumonia are a frequent challenge.~     Nevertheless it seems that there are great differences in standard of care between hospitals.~     The investigators hypothesized that medical education and implementation of evidence-base~     guidelines can reduce the duration of mechanical ventilation in patients presenting of~     hospital acquired pneumonia~   "
16683|NCT03348566|"~     the investigators tested whether genetic variants near FADS cluster, which were recently~     identified to be signatures of adaptation to fish- and n-3 PUFAs-rich diet, interacted with~     these dietary factors on long-term change of body mass index (BMI).~   "
16684|NCT03348553|"~     In this randomized, controlled clinical study firstly the bioavailability of fatty acids and~     micronutrients of JP+® Omega Blend will be analysed. Secondly, the effect of the constituents~     contained in the nutraceuticals on blood lipid values will be determined. Thirdly, it will be~     examined, whether a dose-dependent effect of the supplementation of JP+® Omega Blend exists.~     Fourthly, the effect of a combined consumption of JP+® Omega Blend and Juice Plus+® Orchard,~     Garden and Vineyard blend (JP+® OGV) is investigated.~   "
16685|NCT03348540|"~     Participants will complete a pre and post training psychological assessment. Participants~     will be assigned to attention control training or the comparison stimuli computer task in a~     double-blind randomized control trial design. Both computerized dot probe tasks display two~     faces on a computer screen, one above the other, followed by a small right or left arrow~     appearing in the location vacated by one of the faces. Participants are required to respond~     as quickly as they can by pressing the indicated right or left arrow on their computer~     keyboard without compromising accuracy. Participants complete 6 training sessions.~   "
16686|NCT03348527|"~     A Single Blind, Two-Stage Dose Finding Study to Evaluate the Safety, Tolerability and~     Efficacy of a Single Liproca® Depot Injection into the Prostate in Patients with Localized~     Prostate Cancer,Assigned to Active Surveillance who are at High Risk for Disease Progression~     (followed by an Open Label Extension with a Repeat Injection (Optional))~   "
16687|NCT03348514|"~     This is a first-in-human, Phase I, multicenter, open label, dose escalation study to evaluate~     the DLTs and MTD and to determine the recommended Phase 2 dose (RP2D) of CPX-POM administered~     IV in patients with any histologically- or cytologically-confirmed solid tumor type.~   "
16719|NCT03348098|"~     The purpose of this study is to evaluate the efficacy and safety of apatinib in patient with~     TNBC~   "
16688|NCT03348501|"~     Multiple Endocrine Neoplasia type I (MEN1) or Wermer syndrome is an autosomal dominant~     disease that predisposes patients to the development of endocrine tumours, principally~     parathyroid, pituitary or duodenal-pancreatic tumours. It is due to mutations that abolish~     the function of the MEN1 gene, which contributes to tumour regulation. It is a rare disease,~     with an estimated prevalence in the general population of 1/30,000. Penetrance of the disease~     is late but very high (almost 100% at 50 years of age). The first clinical manifestations~     usually appear after the age of 30 or 40 years.~      The three cardinal endocrine characteristics of MEN1 are secreting tumours of the~     parathyroid, the pituitary gland and the pancreas. Tumours of the adrenal glands, bronchial~     or thymic endocrine tumours, ependymoma and meningioma of the central nervous system,~     visceral leiomyomas, and certain cutaneous tumours can also be found as well as these~     cardinal tumours.~      The diagnosis of MEN1 is essential to ensure 1) appropriate therapeutic management of the~     proven endocrine manifestations 2) screening for other endocrine and non-endocrine tumours~     (lesions), 3) family screening of affected relatives whether they are symptomatic or not 4)~     the surveillance of thus diagnosed patients. Studies on mortality in MEN1 have shown that the~     causes of death are mainly due to the disease. The non-diagnosis of MEN1 is a cause of~     therapeutic failure in the management of the endocrine lesions. For the success of the~     surgical treatment of an isolated endocrine lesion it is important for patients to be~     oriented towards a diagnosis of MEN1 as the management is different from that in usual~     situations. Detection is thus of major importance, as early diagnosis can improve the~     management.~      Even though the syndrome was discovered in 1903 by Erdheim and correctly documented in 1954~     by Wermer, it was only in the 1970s that we became aware of the variety of clinical forms and~     attempted to codify its treatment. Nonetheless, published studies are fragmented and concern~     selected populations of few patients. They only partially answer questions arising in~     clinical practice concerning the prognosis and optimal management of patients. The natural~     history of the disease in all of its clinical forms is still poorly understood. Although~     advances in genetics have helped in the diagnosis of MEN1, some clinical forms are still~     difficult to associate with the syndrome: atypical forms, forms with hardly any symptoms and~     no genetic diagnosis (10%). These clinical forms need to be clarified to ensure optimal care.~     Only a large cohort will make it possible to describe the different forms of this disease and~     to clarify its prognosis~   "
16689|NCT03348488|"~     Background: Haemodynamic instability during haemodialysis has long been linked to poor~     cardiovascular outcomes. It does not always reflect overall hydration but rather plasma~     volume depletion, with a delay in plasma refill from other body compartments, and~     vasodilatation, mediated by endothelial factors. Our understanding of these processes remains~     largely incomplete. Despite our ability to monitor relative blood volume during haemodialysis~     our knowledge concerning the factors affecting plasma refill remain incomplete. This may be~     due to variations observed between individuals. Understanding the pattern of fluid shifts~     variation between the different body compartment and the factors affecting these behaviours~     in different individuals or at different hydration states could be a vital component of our~     management of intradialytic haemodynamic instability but also overhydration.~      Aims and Objectives: The aim of this study is to describe plasma refill rate, during~     haemodialysis using a non-invasive, continuous, real-time data capture during~     ultrafiltration. The study will attempt to describe different refilling phenotypes in the~     study population and seek association with biochemical and haematological parameters linked~     to variability in refilling rates.~      Methodology: This study will attempt to describe variations in the plasma refill rate of~     prevalent dialysis patients during their normal haemodialysis treatment and during a session~     of 3 hours of haemodialysis preceded by 1 hour of isolated ultrafiltration using the in-built~     blood volume monitoring module of their haemodialysis machine and the TMON software that~     collects continuous, real-time data by interfacing with the computer network. To achieve~     this, a bolus of 100-300ml of intravenous dialysis replacement fluid will be administered at~     the beginning of each of the 2 studied sessions.~   "
16690|NCT03348475|"~     The Brain Over Binge Recovery Guide (Hansen, 2016), is a self-help approach that~     incorporates fundamental aspects of Acceptance and Commitment Therapy, Dialectical~     Behavioural Therapy, Motivational Enhancement Therapy and addictions treatment. This approach~     has been streamlined into a guided self-help protocol (Binge Focused Therapy, or BFT) that~     can be delivered by undergraduate students with minimal mental health experience in 3 group~     sessions spread over 8 weeks (i.e., Week 1, Week 2, Week 8). The aim of this proof-of-concept~     study is to provide preliminary data to examine whether this approach is feasible and has~     clinical potential for patients with binge eating disorder.~   "
16691|NCT03348462|"~     Psoriasis is a common immune mediated inflammatory skin disease characterized by red heavily~     scaled plaques. Anthralin (1,8-dihydroxy-9-anthrone) which was introduced over 80 years ago~     has shown excellent efficacy in the management of psoriasis.Although anthralin is remarkably~     effective in the management of psoriasis, its side effects are equally disturbing. Its use is~     messy as it stains the skin, clothing, and any furniture that it may come in contact with.~     Further, anthralin has irritating, burning, brown discoloration and necrotizing effect on the~     normal and the diseased skin. This troublesome profile has discouraged wide-spread use of the~     drug.~      Ethosomes are attractive vesicular carriers mainly composed of phospholipids, ethanol and~     water. The intriguing features of ethosomes are due to their high ethanol content which~     facilitate their penetration through stratum corneum and target deep skin layers. This is~     advantageous over conventional liposomes which have limited penetration through the skin and~     remain confined in the upper layer of the stratum corneum. Compared to liposomes, ethosomes~     had greater retention of methotrexate into the skin for a longer period of time, suggesting~     better therapeutic outcome.~   "
16692|NCT03348449|"~     Retrospective cohort of virologically suppressed HIV-infected patients who received the~     combination of Raltegravir plus Darunavir boosted with cobicistat or ritonavir, as dual~     therapy, because or toxicity or intolerance to nucleoside analogues~   "
16693|NCT03348436|"~     This study to investigate the effects of RF ablation on left atrial systolic function in~     patients with atrioventricular nodal reentrant tachycardia (AVNRT) and atrioventricular~     tachycardia (AVRT).~   "
16694|NCT03348423|"~     The primary objective of this study is to evaluate the analgesic efficacy of DEX-IN compared~     with placebo and active control (fentanyl), in subjects undergoing painful outpatient and~     office based procedures.~   "
16695|NCT03348410|"~     GESAM is a randomized controlled intervention study that addressed women and men on long-term~     sick leave in Uppsala County. Participants which are on sick leave due to mental illness~     and/or pain and were expected to reach the time limit within the in health insurance will be~     offered to participate in an intervention.~      Those how give informed consent will be randomly assigned one of the following groups: 1)~     informing and motivating intervention with insurance officer 2) control group. The main~     purpose of the study is to facilitate the return to work (preventing a return to the public~     health insurance) during the project period.~   "
16696|NCT03348397|"~     Pulmonary homografts are standard substitutes for right ventricular outflow tract~     reconstruction in congenital heart surgery. Unfortunately shortage and conduit failure~     secondary to early calcifications and shrinking are observed particularly for small sized~     conduits in younger patients. In neonates, Contegra® 12mm could be a valuable alternative,~     but conflicting evidence exists. This retrospective study compared the outcome of these two~     conduits in a newborn population.~   "
16697|NCT03348384|"~     The goal of this study is to compared [C-11]NOP-1A binding in recently abstinent cocaine use~     disorders and controls.~   "
16698|NCT03348371|"~     The aime of this study is to envsitigate if ethanol has an incretin effect. This is done by~     administration of ethanol orally vs. an isoethanolaemic i.v. infusion of ethanol.~   "
16700|NCT03348345|"~     The purpose of this study is to evaluate the efficacy of the 7-week Eat Breathe Thrive (EBT)~     program which was designed to increase positive body image, awareness, self-regulation, and~     mindful eating habits. This program aims to achieve these things through psychoeducation of~     cultural influences of beauty standards, the basic neuropsychological systems in the body and~     how they affect eating habits, creating a community within the group members for support, and~     finally through the practice of yoga. In this randomized-controlled trial (RCT),~     investigators will be looking at whether EBT is effective in a community sample of adult~     (18-65 years old) men and women at preventing and decreasing eating disorder risk and~     increasing positive body image and emotion regulation skills through being in tune with one's~     own body, mind, and community. This will take place in a sample of community members taken at~     ten different sites around the United States and the United Kingdom.~   "
16701|NCT03348332|"~     Assessing the role of moderate exercise in newborn intrapartum variables have showed to be~     crucial not only on prescribing exercise safely, but also on understanding its impact on the~     prevention of some cardio-metabolic diseases after labor. Clarify this concept will be~     essential on reducing human risk for some chronic diseases through implementing supervised~     exercise programs during such a critical period.~   "
16702|NCT03348319|"~     Limited pancreatic resections are increasingly performed, but the rate of postoperative~     fistula is higher than after classical resections. Pancreatic segmentation, anatomically and~     radiologically identifiable, may theoretically help the surgeon removing selected anatomical~     portions with their own segmental pancreatic duct and thus might decrease the postoperative~     fistula rate. Current pancreatic segmentation theories do not enable defining~     anatomical-surgical pancreatic segments. To our knowledge, no study has tried to describe~     pancreatic segmentation from the divisions of the pancreatic ducts to date. Hence, we~     hypothesize to explore the possibility of pancreatic segmentation following pancreatic ducts,~     using extensive reconstructions of pancreatic duct using micro-scanner on injected human~     pancreas.~   "
16703|NCT03348306|"~     Introduction~      AntiPhospholipid antibody Syndrome (APS) is an acquired autoimmune disorder defined by the~     presence of persistent thrombosis or obstetric manifestations together with the presence of~     persistent antiphospholipid antibodies (aPL). Patients are young and at high risk of~     recurrence. The current challenge is the identification of patients at high risk of organ~     damage that directly impact morbidity and mortality.~      Small vessels thrombosis can be asymptomatic but detectable by MRI. Apart from APS, it was~     shown that the detection of asymptomatic ischemic events identify patients at risk for~     symptomatic ischemic events. Demonstrating this in patients with APS would prevent thrombotic~     complications.~      The investigators' hypothesis is that a significant proportion of patients with APS would~     have asymptomatic organ involvement.~      Objectives~      The primary objective is to determine the frequency of asymptomatic target organ (s) (heart,~     brain, kidney) in APS patients.~      Secondary objectives are (i) to determine the frequency of each type of MRI abnormality, (ii)~     to identify the factors associated with asymptomatic target organ lesion, (iii) to describe~     the parameters of echocardiography associated with cerebral and cardiac MRI, and (iv) to~     assess the feasibility of a one-time cardiovascular and brain MRI.~      Methods and analysis~      This is a prospective interventional, cross-sectional, non-randomized, monocentric clinical~     study. The investigators expect to include 50 consecutive patients with APS followed in the~     department of Vascular Medicine at Nancy University Hospital.~      Within 15 days post-inclusion, a one-time cardiac and cerebral MRI will be performed. For~     each patient, the number of target organs involvements will be calculated and the frequencies~     will be compared by Fisher or chi-2 tests.~   "
16704|NCT03348293|"~     Scope of tumor resection was simulated according to the MR imaging data. After meticulous~     design, the investigators created the personalized porous biodegradable scaffold and printed~     by 3D printer, using porous PCL biomaterials. During operation, the biodegradable scaffold~     was implanted into the defective cavity after tumor resection. Safety indicator, cosmetic~     outcome and autologous compatibility were evaluated.~   "
16705|NCT03348280|"~     This trial will evaluate whether a particular type of circulating white blood cell,~     monocytes, from type 2 diabetics with high blood pressure and vitamin D deficiency vs.~     sufficiency will induce hormones that increase blood pressure.~   "
16706|NCT03348267|"~     Soccer is an intermittent sport including a high number of powerful actions such as~     accelerations, decelerations, changes of direction, jumps and impacts that incorporate a~     strong eccentric component and may therefore lead to skeletal muscle damage. Indeed, match~     activity is associated with the onset of muscle damage and an acute inflammatory response~     that result in attenuated performance for as long as 1 to 3 days. In competitive soccer~     though, multiple matches are performed within a small-time frame resulting in inadequate~     muscle recovery and reduced field performance. Supplementation with milk proteins following~     intense exercise protocols has been shown to stimulate protein synthesis and facilitate~     muscle recovery. Thus, the aim of the present investigation is to examine the effects of milk~     protein supplementation on muscle recovery and soccer-specific performance during an~     in-season microcycle with two matches performed three days apart.~   "
16707|NCT03348254|"~     A retrospective study will be performed to compare the incidence of revision procedures~     performed for the treatment of postoperative periprosthetic joint infection (PJI) between~     patients treated with a single preoperative antibiotic prophylaxis and patients treated with~     multiple shot antibiotic prophylaxis following primary arthroplasty of hip or knee.~      This study will be conducted in two phases. In phase 1 the investigators will evaluate which~     antibiotic prophylaxes (type of antibiotic and duration of prophylaxis) are regularly used in~     the Netherlands, by contacting all orthopaedic centres implanting total hip and total knee~     prostheses. In phase 2 the investigators will compare infection rate (defined as revision for~     infection as registered in the LROI database) between a single-shot and multiple shot~     antibiotic prophylaxis.~      Knee and hip primary arthroplasties will be considered separately.~   "
16778|NCT03347331|"~     This clinical assay is designed to validate that [18F]F13640 as a radiotracer of 5-HT1A~     functional receptors. A first group of healthy subjects underwent a PET scan with arterial~     blood sampling to determine the kinetic model of the tracer. A second group of healthy~     subjects underwent a classical test-retest study (i.e two distant PET scans) to determine the~     reproducibility of measures.~   "
16708|NCT03348241|"~     This study was designed to investigate the effect of Gum Arabic (GA) on cancer patients to~     prevent chemotherapy-induced oral mucositis. Cancer patients who will receive chemotherapy~     were divided into two groups; study Gum Arabic group (which received GA with chemotherapy)~     and control group (chemotherapy alone); and the participants were recruited to reach 190~     patients in the study group and 184 patients in control group. This clinical trial was~     conducted in outpatient chemotherapy sections at Radiation and Isotopes Center of Khartoum.~     This study was designed to test the theory that say the chemotherapy-induced oral mucositis~     will significantly decrease after ingestion 30 grams as daily dose of Gum Arabic in a form of~     solution for six weeks during therapy.~   "
16709|NCT03348228|"~     Hydroxycitrate (HCA) is a compound extracted from the fruit, Garcinia Cambogia.~     Hydroxycitrate supplements are available over the counter and are primarily promoted as a~     weight loss supplement. There has been recent evidence that hydroxycitrate is a potent~     inhibitor of calcium oxalate crystal growth and can lead to the dissolution of the crystals.~     The purpose of this research study is to study the effect of Hydroxycitrate (HCA) supplements~     on HCA urinary excretion and on urine chemistries in kidney stone formers and normal~     subjects.~   "
16710|NCT03348215|"~     This series of single case studies aims to test the feasibility and acceptability of an~     enhanced treadmill system for the recovery of gait function in stroke survivors. Forty adult~     participants who have had a stroke in the past year that resulted in impaired gait function~     and are attending a local hospital for gait training, will be recruited. Participants will be~     asked to attend a rehabilitation clinic for seven weeks, three times a week where they will~     receive enhanced treadmill training supervised by a physiotherapist. Assessment sessions will~     take place in week 1, weeks 5 and 8, and after 3 months. Outcome measures recorded during~     assessment sessions will include gait variables (e.g. speed, cadence, step length and joint~     kinematics) measured overground and on the treadmill using motion capture technology and~     outside using body worn sensors (inertial motion unit). Participants will complete a~     questionnaire on their community walking habits and asked to wear a physical activity monitor~     for 48 hours to record stepping time.~      The basic intervention will comprise of walking on a treadmill capable of adjusting its speed~     to match that of the user (using feedback from the motion capture system) and a large~     television screen showing a virtual reality scene (woodland walking) with visual~     perturbations (virtual obstacle avoidance). In addition participants will be divided equally~     and randomly (Latin square) to either wear an ankle foot orthosis (AFO group) or functional~     electrical stimulation (FES group) while walking on the treadmill but not provided for home~     use. Training sessions will last up to a max of 20 minutes, will be supervised by a~     physiotherapist and participants will wear a safety harness to remove any risk of trip falls.~     Any adverse event such as muscle/joint pain, illness or a fall at home will be recorded,~     participants and physiotherapists will also be asked for feedback on their experience with~     the treadmill system using questionnaires and semi-structured interviews~   "
16711|NCT03348202|"~     The EMMY Project is an interdisciplinary and mixed methods comparative study on impact of~     welfare systems on mental wellbeing among the oldest old in Finland, Italy, Norway and Spain,~     including aspects such as equity, social inclusion, empowerment and participation.~      The project will delineate the concept of mental wellbeing at old age by qualitative methods,~     and will dissect the links between welfare systems and mental wellbeing by quantitative~     methods. It will support exchange of good policies between EU Member States by performing~     case studies of existing welfare policies and systems in the four participating countries,~     and it will develop a new research-based tool for assessing the mental wellbeing impact of~     welfare policies in old people.~      The overarching aim of this interdisciplinary, comparative research project is to improve our~     knowledge and understanding of how different welfare models and related policies, as well as~     health and social care service approaches, can benefit from adaptation in order to target~     mental wellbeing in the oldest-old.~      The project will support development of social welfare models in order to incorporate a~     change of focus from mental disorders to mental wellbeing among old people.~      This is important, not only because of the ageing of the European population, but also~     because of increasing pressures on public finances, within and beyond Europe.~   "
16712|NCT03348189|"~     The primary objective of this study is to evaluate the % oxygen saturation by pulse oximetry~     accuracy of a combined pulse oximetry system which consists of a Nonin sensor ), an adaptor~     cable, and an oximetry system during non-motion conditions.~   "
16713|NCT03348176|"~     Overweight and obesity in preschool children is more and more common and predicts overweight~     in later childhood and adulthood. A healthy eating pattern with many vegetables decreases the~     risk to develop overweight. As many food preferences are learned in the first years of life,~     teaching children to like vegetables from the very start of eating solid foods is essential.~     Starting baby's first bites of solid foods with vegetables instead of more sweet tastes like~     fruits may promote vegetable liking. Also, it is important that parents know how to feed~     their children: e.g., paying attention to whether the child is hungry or full is essential,~     as is not pressuring them to eat. What is yet unknown is which of these two are more~     important to promote, to facilitate vegetable liking in young children. Is starting with~     vegetables most important, or educating parents on their feeding-techniques? And is a~     combination of both most effective? This study tests which of three interventions is most~     effective to promote vegetable intake and liking in children up until the age of 3 years: a)~     a focus on the 'what' (starting with vegetables); b) a focus on the 'how' (listen to your~     child's cues while feeding); c) a focus on both the 'what' and the 'how'. These three groups~     will be compared to a control group receiving no advice on how to introduce solid foods on~     children's vegetable intake and liking.~   "
16714|NCT03348163|"~     The purpose of this study is to determine the safety and tolerability of a new HIV~     medication, bictegravir plus emtricitabine plus tenofovir alafenamide (B/FTC/TAF, 3 HIV~     medications combined into one pill) in HIV-infected transgender women (TW).~   "
16715|NCT03348150|"~     A randomized controlled two-armed phase III trial for gastric cancer patients with peritoneal~     dissemination. Randomization between gastrectomy + cytoreductive surgery + HIPEC~     (experimental arm) and palliative systemic chemotherapy (standard arm).~   "
16716|NCT03348137|"~     This research trial studies how well Oncology Research Information Exchange Network (ORIEN)~     works in improving genetic screening rate in patients with cancer. Implementation of Progeny~     Genetic Pedigree and Family History Questionnaire software across all ORIEN member~     institutions may add value and utility for recognizing and caring for patients with an~     inherited susceptibility to cancer.~   "
16717|NCT03348124|"~     This study aims to evaluate an intervention using the Toolkit Children - what does it~     involve? and the Real-Care-Baby (RCB) simulator among students with intellectual~     disability (ID), using a cluster randomized trial design with waiting-list control group.~   "
16720|NCT03348085|"~     1. purpose of study: optimal minute could be the prediction of successful weaning and~          become the new weaning parameter.~        2. study design: inclusion criteria: investigators will perform this study at our~          respiratory care center. Patients who had been maintained on mechanical ventilator in~          excess of 3 weeks before respiratory care center admission and all previous weaning~          attempts had ailed.~           Exclusion criteria: Patients do not have spontaneous breath. Terminal cancer stage and~          unstable hemodynamics condition.~        3. study duration: 2016/01/01~12/31~   "
16721|NCT03348072|"~     This is a comparative study on the survival and long-term quality of life of Jehovah's~     witnesses having undergone a cardiac surgery and having refused blood transfusions for~     religious reasons. This group will be compared with two other groups having no restrictions~     on this subject.~      The purpose of the study is to evaluate the impact of this decision on survival and~     postoperative quality of life, in the long term.~   "
16722|NCT03348059|"~     The hypothesis was to check whether baseline anti-E1E2 antibodies could predict virological~     outcome in Hepatitis C virus (HCV)-infected patients receiving direct-acting antiviral~     treatment~   "
16723|NCT03348046|"~     The purpose of this observational study is to assess the safety and effectiveness of~     biosimilar Infliximab in patients with rheumatoid arthritis(RA) in Jordan where no visits or~     intervention(s) additional to the daily practice will be performed~   "
16724|NCT03348033|"~     The purpose of this study is to evaluate safety, feasibility and maximum tolerated dose of NK~     cells cultured in vitro as adjuvant treatment of patients with chronic myeloid leukemia~     candidates to allogenic bone marrow transplantation or refractory to conventional treatment.~   "
16725|NCT03348020|"~     Determine the effects of reducing whole-body iron stores in overweight/obese subjects (via~     one-time blood donation) on adipose tissue iron content, factors regulating iron homeostasis~     and lipolytic rate in adipose tissue, as well as measures of adipose tissue and whole-body~     insulin resistance.~      After a screening visit to determine eligibility, subjects will undergo a battery of tests~     for the determination of primary outcome measures at baseline. They will then donate 1 unit~     (~500 mL) of blood (at a local blood donation center) and return for a follow-up testing 4~     weeks after blood donation. During the 4-week period between study trials, subjects will be~     required to maintain a stable body mass and not alter their dietary or physical activity~     habits.~   "
16726|NCT03348007|"~     The study objectives are to evaluate the efficacy and safety of a 2-week daily intake of 1L~     Hépar® natural mineral water rich in magnesium sulphate compared to a control natural mineral~     water in the treatment of the constipation symptoms in women outpatients.~   "
16727|NCT03347994|"~     Minnelide, a water-soluble disodium salt variant of triptolide, is a diterpenoid heat shock~     protein 70 (HSP70) inhibitor. Studies using AML cell lines, primary patient samples, and~     mouse transplant models demonstrate that Minnelide has potent cell killing effects. Minnelide~     has already been developed for human use and given to patients in a phase I trial for~     gastrointestinal (GI) cancers. Given the clinical safety profile and preliminary activity~     described in human GI cancers, the low-nanomolar anti-leukemic potency of triptolide in~     vitro, and that minnelide doses predicted to be significantly below the maximum tolerated~     dose (MTD) in human GI cancers decreased leukemia burden in animal models, the investigators~     propose a phase I trial in acute myeloid leukemia (AML).~   "
16728|NCT03347981|"~     Prospective, randomised, controlled, single-surgeon, single-center post-market clinical~     follow up study to compare the clinical outcomes of two trifocal IOLs with different material~   "
16729|NCT03347968|"~     A Phase 1 study to evaluate the effect of MEDI0382 on PK and PD of warfarin and esmolol in~     healthy subjects.~   "
16730|NCT03347955|"~     A double-blind sham surgery-controlled trial was developed to determine the effectiveness of~     implantation of human embryonic dopamine neurons into the putamen of patients with advanced~     Parkinson's disease (PD), with half the patients receiving the implant (n = 20) and half~     receiving sham surgery (n = 20). The blind was maintained for 12 months before participants~     were told which surgery they received, at which time those receiving sham surgery could~     request the implant surgery.~   "
16731|NCT03347942|"~     Objectives: To evaluate the impact of the meal time administered on the body weight of adult~     individuals of both sexes, being overweight and obese.~      Experimental design: randomized controlled trial. Place of research: Hospital de Clínicas de~     Porto Alegre, Porto Alegre, RS, Brazil.~      Materials and methods: Anthropometric data, blood pressure, waist diameter will be measured;~     venous blood samples will be collected and stored for glucose, total cholesterol,~     triglycerides, HDL-cholesterol, urea, creatinine and ALT in serum.~      Intervention: Wait at least 20 minutes after finishing the first portion of meals, previously~     considered sufficient by the individual before serving again. The control group will also~     serve the dish the same way, but you can serve additional portion without waiting.~      Measurements: P values less than 0.05 will be considered statistically significant.~      Expected results: Weight loss, decrease in anthropometric markers and risk factors for~     cardiovascular diseases.~   "
16732|NCT03347929|"~     This study will evaluate whether treatment with Naproxen 500 mg twice daily is superior to~     placebo for the improvement of leg pain in patients with sciatica. Half of patients will~     receive Naproxen while the other half will receive placebo.~   "
16733|NCT03347916|"~     to study the effect of oral gabapentin (5 mg/kg) on emergence agitation after desflurane~     anesthesia in pediatrics undergoing starbismus surgery~   "
16734|NCT03347903|"~     Gastroesophageal reflux disease (GERD) is involved in the development of esophageal motility~     disorders like Jackhammer esophagus (JE), a novel hypercontractile condition that was~     associated with progression to achalasia and limited outcomes following surgical anti-reflux~     therapy.~      This trial was designed to assess the prevalence and characteristics of JE in patients with~     typical symptoms of GERD and responsiveness to PPI therapy.~   "
16779|NCT03347318|"~     The main purpose of this study is to define the molecular profile of selected solid tumors.~     From each participants will be collected biological materials for molecular analysis,~     including saliva, blood and vital tumor tissue derived form surgical or biopsy procedures.~     Whereas possible, vital tumor specimens will be inoculated and propagated in~     immunocompromised NOD/SCID mice to study the genetic correlations between genetic status and~     response to target drugs.~   "
16735|NCT03347890|"~     The study aims to investigate the effects of 3.0 mg of liraglutide on reward brain circuits~     in human obesity and to better understand its effects on weight loss (in patients without~     diabetes).~      According to the study protocol, 70 obese patient will be evaluated at baseline and at~     16-week (end of study) after daily subcutaneous injections of Saxenda® (liraglutide 3.0 mg)~     or Placebo by pen injector.~      All participants will first undergo a functional Magnetic Resonance Imaging (fMRI) session~     while being presented with gustatory stimuli. Second, participants will complete behavioural~     tasks (i.e., liking versus wanting, in the scanner) and questionnaires aiming at teasing~     apart reward mechanisms and emotional skills (e.g., emotional regulation ability) associated~     with food intake. Third, metabolic parameters and hormones involved in appetite regulation~     will be assessed and studied in relation to fMRI.~      These measurements will be repeated after 16 weeks in obese individuals. The control group of~     normal body weight individuals will be evaluated once at Baseline.~   "
16736|NCT03347877|"~     The trial evaluates the clinical efficacy and safety of autologous osteo-periosteal cylinder~     graft transplantation for Hepple V osteochondral lesions of the talus. Half of participants~     will receive autologous osteo-periosteal cylinder graft transplantation, while the other will~     receive osteochondral graft transplantation as a control group.~   "
16737|NCT03347864|"~     This is an open-label positron emission tomography/computed tomography(PET/CT) study to~     investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-RM26 in breast~     tumor patients. 1.85 MBq per kilogram body weight of 68Ga-NOTA-RM26A will be injected~     intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.~   "
16738|NCT03347851|"~     The purpose of this pilot study is to obtain both near valve and downstream flow~     characteristics, using 3D transthoracic echocardiography and 4D flow MRI respectively, in an~     existing patient population at Northwestern Memorial Hospital, to determine the hinge washout~     characteristics and downstream flow patterns of the On-X valve and compared to competing~     designs.~   "
16739|NCT03347838|"~     The goal of this clinical research study is to determine whether the PD-1 inhibitor~     (Programmed cell death protein 1) nivolumab improves premalignant bronchial dysplastic~     lesions in subjects that are at high risk for the development of lung cancer, including those~     with a prior smoking history, or history of lung cancer or head and neck cancer. The safety~     and tolerability of nivolumab will also be studied.~   "
16740|NCT03347825|"~     The main objective of this study is to compare perioperative outcomes for robotic-assisted~     lobectomy with those associated with VATS and open lobectomy for lung cancer~   "
16741|NCT03347812|"~     Aortic disease is a kind of cardiovascular diseases with very high mortality rate and high~     risk of surgical treatment. At present, the surgical and endovascular treatment for diseases~     in the ascending aorta, descending aorta and abdominal aorta are becoming more and more~     mature. However, due to the complexity of the aortic arch in anatomy, function and~     pathological changes, the optimal treatment strategy for diseases in the aortic arch has been~     controversial constantly.~      This research is a multi-center(four centers), prospective, controlled, large-scale (about~     400 subjects) clinical study, using traditional thoracic surgery of aortic arch disease as a~     control to verify that new techniques for endovascular treatment is not inferior to~     traditional thoracic surgery in terms of efficiency and safety.~      Further more, the investigators plan to explore the indications of the application of these~     new techniques, develop a better diagnosis and treatment program, reduce the risk of such~     surgical treatment and the incidence of complications, improve clinical efficacy and the~     overall quality of the disease.~   "
16742|NCT03347799|"~     When a child was born too early, it is more likely to develop an alteration of its visual~     function than in the case of term birth. Significant visual disturbances are found in 3% of~     children born prematurely, but visual impairment can be very severe, up to the loss of vision~     in case of retinopathy of prematurity (ROP) in the most immature infants. The introduction of~     screening surveillance systems, such as WINROP software, might reduce the need for stressful~     eye examination in low risk neonates. This retrospective study aimed at validating the WINROP~     algorithm in a cohort of premature infants, born below 32 weeks of gestation, who had~     systematic eye examination for ROP screening over 4 year period.~   "
16743|NCT03347786|"~     The purpose of this research study is to test an experimental procedure called intra-arterial~     delivery of verapamil in patients diagnosed with acute ischemic stroke. This study~     investigates the safety of intra-arterial delivery of verapamil, a drug used to treat~     vasospasm (spasm of a blood vessel), and how it affects recovery from stroke. Recruitment is~     limited to patients that have received mechanical thrombectomy as standard of care.~   "
16744|NCT03347773|"~     Chronic kidney disease patients with sarcopenic obesity are noted to have impairment in~     physical performance and reducing their quality of life, and the investigators also founded~     these patients are at higher risk of mortality. Thus, the investigators hypothesize that oral~     nutrition intervention could increase lean tissue mass in these patients and improve the~     clinical outcomes.~   "
16755|NCT03347630|"~     The role of MRI in the management of esophageal cancer remains unclear and poorly studied.~     Recent technical advances suggest that MRI may become a powerful technique for the initial~     assessment of esophageal cancer, but also for the evaluation of response to neo-adjuvant~     treatment before surgery.~      This imaging study will be performed prospectively and consecutively in 60 patients included~     over a 18-month period in patients wîth newly diagnosed esophageal cancer.~      The aim of this study is to assess the accuracy of MRI to visualize esophageal tumors, to~     assess tumor burden and potential contact with adjacent structures as well as associated~     lymph nodes. If chemotherapy or radio-chemotherapy treatment is indicated before surgery, we~     will also evaluate whether MRI helps us to better evaluate the response to this treatment in~     comparison to PET-scan or echo. endoscopy which are the examinations currently performed to~     evaluate the effectiveness of these treatments.~      The images of the MRI exams will be interpreted by 1 expert radiologist with no knowledge of~     the other imaging modalities and transmitted to the doctors in charge for possible~     consideration for the treatment.~      Patients will then be followed for one year according to clinical management standards to~     study the data on treatment complications and cancer progression at one year.~      The main risk is the administration of a gadolinium chelate-based MRI contrast product used~     routinely. There is also a risk that the results of the MRI may influence the treatment~     initially planned for example by canceling a surgical procedure.~   "
16745|NCT03347760|"~     Infectious myocardities are frequent, most of the time viral and can evolve to cardiac~     insufficiency. The diagnostic is difficult because they can mime an acute coronary syndrome.~     Approximately 10 % of patients with acute infarction suspected, have a normal angiography,~     and half of them has in fact a myocarditis, as showed studies of cardiac MRI among which some~     realized in our department . However, anomalies observed in MRI are not specific and it is~     necessary to use multiples criterias. A new radiopharmaceutical, the 68Ga-DOTATOC, specific~     of somatostatine's receptors which are over expressed by the inflammatory cells, has recently~     showed the capacity to identify myocardities, but only in a small group of 6 patients.~      The investigators make assumptions:~        1. this radiopharmaceutical is enough sensitive to detect most of the acute inflammatory~          myocardities which are identified by the MRI and~        2. it could maybe allow to identify myocardities with a persistent subacute or chronic~          inflammation, which are difficult to identify with cardiac MRI, and it would be a new~          information able to guide the medical decision.~      Primary objectif: to determine if PET with 68Ga-DOTATOC is enough sensitive to identify~     myocardities in acute inflammatory phase by hospitalized patients with suspected acute~     infaction and with normal angiography and who have a high probability of myocarditis~     identified by MRI. Disease prevalence will be close to 100 % at baseline Secondary~     objectives: 1. Estimate the frequency of inflammatory forms (subacute or chronicle), with a~     68Ga-DOTATOC PET at 3 to 5 months from baseline, when classic signs of acute inflammatory~     generally disappeared (CRP, Troponine-I, myocardial oedema in MRI).~      2. Analyze the concordance of the results of 68Ga-DOTATOC TEP by two readers~   "
16746|NCT03347747|"~     The primary objective of this study is to create digital 3D images of subjects using a~     Canfield VECTRA H1 digital imaging system and compile a medical, skin/sun exposure and~     sunscreen use, and skin care product history for a large number of subjects. This data will~     allow for image and statistical analysis to determine if facial volume loss is greater on one~     side, and what factors may be causing this.~      The data collected will also serve as a database for future lines of inquiry relating to data~     collected in this study. Your data (including 3D images) will be kept in this database and~     may be accessed in the future by any Sponsor or Investigator. Your data will be de-identified~     and your name will not be associated with the questionnaire responses~   "
16747|NCT03347734|"~     Hypermetropia in school-aged children is a pathology which is very common and responds to~     treatments early. No studies have been found in the literature on the efficancy of the~     hypermetropia treatments with physiotherapy methods. In our study, it was aimed to~     investigate the effects of different eye exercises on hypermetropia defects in school age~     children aged 7-17 years and to determine whether exercise protocols have superiority against~     each other.~   "
16748|NCT03347721|"~     This study is to determine if there is a clinically meaningful difference in pain perception~     for women during in-office diagnostic flexible cystoscopy when using lidocaine gel vs plain~     lubricant. This will be a double blinded randomized control trial.~   "
16749|NCT03347708|"~     The purpose of this study is to compare the safety and preliminary efficacy of intradiscal~     injections of two doses of IDCT (Discogenic Cells + Sodium Hyaluronate vehicle) and two~     controls (saline, Sodium Hyaluronate vehicle) in subjects with chronic low back pain due to~     Degenerative Disc Disease (DDD) at one lumbar level from L3 to S1.~   "
16750|NCT03347695|"~     Atrial fibrillation(AF) often occurs in patients with mitral valve disease. Both mitral~     replacement and mitral valve plasty are the effective methods to the mitral valve disease.~     How to cure atrial fibrillation is the key to full recovery. Radiofrequency ablation (RFA) in~     surgery is an effective treatment for those patients. But there are some recurrence rate of~     AF in RFA. So the investigators design a modified Cox-Maze procedure in surgery and study the~     outcome in order to prevent the recurrence rate.~   "
16751|NCT03347682|"~     The aim of this study is to investigate the Reliability and construct validity of the Turkish~     version of the Prosthesis donning and doffing questionnaire in transtibial amputees.~   "
16752|NCT03347669|"~     Fibromyalgia (FM) is characterized by chronic diffuse pain and affects 0.5 to 5% of the~     population, with a higher prevalence in women1. This condition is characterized by joint and~     muscle pain, also associated with fatigue, migraine, sleeps disorders, depression and~     irritable bowel syndrome2. The presentation of these various symptoms varies greatly from one~     patient to another, with great heterogeneity in clinical, physical, social, psychological and~     therapeutic responses. . A recent parliamentary inquiry report called for recognition of the~     disease and recommended to build a unified care path for patients; a collective expertise is~     led by INSERM to help in patient care. Faced with the heterogeneity of FM, several~     international studies have attempted to identify subgroups of patients based essentially on~     clinical symptoms of the disease3-8, including a recent Korean study of 313 patients9, which~     suggested four groups, but with methodological limitations, not taking into account the new~     criteria10 for evaluating FM.~      Recent studies have also shown that there is a peripheral neuropathic component in the~     mechanisms of this pathology, demonstrated by a decrease in the density of the epidermal~     nerve fibers11-12, called small fiber neuropathy (SFN) neuropathy. It is an attack of small~     sensory and sympathetic nerve fibers, causing pain, paresthesia as well as disturbances of~     the autonomous system. Other studies also suggested that a significant proportion of patients~     diagnosed with fibromyalgia had SFN, demonstrated by cutaneous biopsy13-14 or confocal~     microscopy of the cornea15. A new device, the Sudoscan®, makes it possible to detect a SFN~     much simpler, faster and less invasive than the technique of ophthalmology or biopsy.~     Although this Sudoscan® test has been used extensively in conditions such as diabetes16-19,~     no study has been used to assess the presence of SFN in FM.~      The aim of this pilot study is to identify the prevalence of SFN in FM patients, using this~     new non-invasive device, in order to have a better defined representation of the prevalence~     of small-fiber neuropathy in an FM population compared to a group of healthy volunteer~     matched in age, sex, BMI and by menopausal status for women.~   "
16753|NCT03347656|"~     The primary aim of the study is to assess the mobility dose in neurocritical care patients~     with ischemic stroke or intracranial hemorrhage and its effects on discharge disposition and~     patient outcomes. The investigators hypothesize that patients' mobilization dose in the~     intensive care unit (ICU) predicts discharge disposition, 90 day Barthel Index and other~     outcomes like muscle wasting (expressed as decrease in rectus femoris cross sectional area~     (RF-CSA) in the paretic and non-paretic limb measured by bedside ultrasound), and ICU length~     of stay (LOS).~   "
16754|NCT03347643|"~     In this study, the investigators aimed to investigate the effect of transcranial direct~     current stimulation (tDCS) on clinical status of Internet game addiction. The clinical status~     of Internet game addiction includes severity of addiction symptom, subjective craving for~     gaming, response inhibition and cue reactivity. The investigators hypothesized that real~     stimulation with tDCS on the dorsolateral prefrontal cortex will have higher effectiveness on~     severity of addiction symptom, subjective craving for gaming, response inhibition and cue~     reactivity rather than sham stimulation with tDCS.~   "
16757|NCT03347604|"~     Objective: Study the effect of body position on spirometry in obese patients as defined by~     waist to hip ratio (WHR) of greater than 0.85 in women, and 0.9 in men~      Background: Spirometry is routinely ordered to work up dyspnea in obesity. The most common~     abnormality is a restrictive disease pattern. The underlying mechanisms of this pattern are~     not completely understood. One plausible explanation is diaphragmatic weakness or skeletal~     muscle weakness. The change in forced vital capacity (FVC) from sitting to supine is a very~     sensitive and specific test for detecting diaphragmatic weakness. The effect of body position~     on spirometry in obesity has not been extensively studied, and there are no studies that look~     at this when obesity is measured by waist to hip ratio. Effect of body position has been~     studied in normal patients, and it is expected the FVC can decrease as much as 10% when~     changing from sitting to supine. The investigators do not know what would be considered 'the~     normal' amount for FVC to decrease by in the obese population, and thus would like to test~     patients with increased WHR both in sitting and supine position. The investigators also want~     to do muscle strength test by measuring the maximal inspiratory and expiratory pressures~     (MIPs and MEPs).~      Anticipated results: the investigators anticipate that our study population will replicate~     the restrictive disease pattern usually seen in obesity. The investigators also anticipate~     for the FVC to decrease when in the supine position compared to sitting. The amount by which~     it decreases will likely fall between 10 -25%. The investigators anticipate to not find any~     abnormalities in MIPs and MEPs in obesity.~   "
16758|NCT03347591|"~     Rationale: Rare bleeding disorders (deficiency of fibrinogen, factor II, V, V&VIII, VII, X,~     XI, XIII, α2-antiplasmin or plasminogen activator inhibitor 1) are not well defined with~     respect to their clinical phenotype, laboratory phenotype en genotype. At present, little is~     known about their clinical presentation, bleeding scores, bleeding episodes, health-related~     quality of life, laboratory parameters, genetics and current treatment. There are large~     differences in bleeding tendency and weak correlations with the level of factor deficiencies.~     Therefore, it is essential to perform thorough research in patients with rare bleeding~     disorders and perform laboratory and genetic tests, to seek explanations for the variety in~     clinical phenotype.~      Objective: The purpose of the RBIN study is to describe the epidemiology, bleeding tendency,~     laboratory parameters, quality of life and genetics of all known patients in the Netherlands~     with rare bleeding disorders. In addition, the study aims to examine the relationship between~     clinical phenotype, laboratory phenotype and genotype.~      Study design: explorative cross-sectional multicenter observational study Study population:~     all patients registered in Dutch Haemophilia Treatment Centers with known disorders of the~     coagulation factors fibrinogen, factor II, V, V & VIII, VII, X, XI, XIII, α2-antiplasmin and~     plasminogen activator inhibitor type 1, aged 1 years and older.~      Main study parameters/endpoints:~      Description of the clinical phenotype, laboratory phenotype, genotype and quality of life.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: participating patients will be invited for one visit to their treatment center~     in order to draw blood, take a saliva sample and perform questionnaires. This will take~     approximately 40 to 120 minutes. Since the population of patients with rare bleeding~     disorders is very small it is important to include all patients, also minors (children <18~     years), in the study (around one third of known patients are minors). Therefore, this study~     may be regarded as group-related. The risk associated with participation is negligible.~   "
16759|NCT03347578|"~     The investigator evaluated diaphragmatic function in patients undergoing thoracic surgery.~     Diaphragmatic displacement was evaluated before surgery, 2 and 24 hours after surgery. Also,~     preoperative spirometry and postoperative spirometry were collected (24 hours after surgery).~   "
16760|NCT03347565|"~     This study of adolescent eating disorders (ED) will examine the association of~     temperament-based classifications, brain activation during incentive processing, and ED~     symptoms at time of scan and 1 year later to better understand the neurobiology and symptoms~     of ED. We will recruit 150 females currently ill with an ED and 50 controls ages 14-17 to~     investigate how temperaments reflecting greater inhibition, impulsivity, or effortful control~     correspond to 1) clinical symptoms and 2) the brain's response to anticipation and outcome of~     salient stimuli, and 3) by collecting follow-up clinical data one year later, identify how~     temperament-based subtypes predict ED symptom change (e.g., clinical prediction). Data~     collection will rely on a technology called functional magnetic resonance imaging (fMRI).~   "
16761|NCT03347552|"~     The purpose of this project is to investigate the effectiveness of the Home-Based Mental~     Health Evaluation (HOME) program, which is an innovative and culturally-relevant suicide~     prevention intervention for Veterans aimed at increasing treatment engagement and decreasing~     suicide risk following psychiatric hospitalization, a period of heightened suicide risk.~   "
16762|NCT03347539|"~     This study explores reasons why adolescents choose to receive a nexplanon implant and remove~     a Nexplanon implant. Nexplanon is provided as part of the standard of care on the University~     of Chicago mobile health unit. This study explores reasons for implantation and removal of~     Nexplanon on this mobile health unit.~   "
16763|NCT03347526|"~     This study proposes to assess the efficacy of Cosyntropin Injectable Suspension, 1 mg/mL~     compared to vigabatrin. Additionally, this study proposes to determine efficacy of~     combination therapy of Cosyntropin Injectable Suspension, 1 mg/mL and vigabatrin to~     monotherapy Cosyntropin Injectable Suspension, 1mg/mL in children with new onset infantile~     spasms (IS).~   "
16764|NCT03347513|"~     the effect of eradication of H-pylori in pregnant patients with iron deficiency anemia on the~     level of hemoglobin after iron therapy.~   "
16765|NCT03347500|"~     Osteoarthritis (OA) is the fastest growing cause of disability worldwide due to population~     ageing and increasing obesity incidence. Obese individuals have a higher risk of OA~     insurgence and severe progression due to several risk factors, including their systemic~     inflammation state and superior migratory ability of monocytes. In the present project we aim~     at the development of a novel 3D microfluidic organotypic model resembling the joint to~     investigate the migration ability of monocytes from obese and non-obese OA patients.~      We hypothesize that monocytes from obese OA patients display superior migration ability and a~     specific pattern of chemokine surface receptors compared to monocytes from non-obese OA~     patients. We also hypothesize that these features lead to a superior infiltration of~     monocytes/macrophages to the synovial membrane in obese OA patients. Based on this, our main~     aim will be to highlight differences between Mo from obese and non-obese OA patients in terms~     of surface receptors and migration ability in a microfluidic organotypic model.~   "
16766|NCT03347487|"~     Several open-label trials have shown the therapeutic promise of deep brain stimulation (DBS)~     in treatment-resistant depression (TRD). However, the results of placebo-controlled trials~     have been mixed.~      Here the investigators will explore whether active DBS in habenula for TRD will result in~     better symptom improvement than sham DBS. This study will also use structural and functional~     MRI to identify the brain network changes between pre-operative, post operative active DBS~     and shame DBS.~   "
25234|NCT03236701|"~     To evaluate the effect on phosphatemia in hemodialysis patients of replacing the meat or fish~     included in two meals a week with an amount of egg white containing the same quantity of~     proteins.~   "
16768|NCT03347461|"~     Otolaryngologists routinely administer ear drops at the time of tympanostomy tube placement~     in order to prevent tube otorrhea; however, there is a lack of consensus as to which drops~     are the most effective, and whether a post-operative regimen should be used. Utilizing drops~     postoperatively places the onus of administration on parents who may have various~     difficulties in delivering the drops to their child's ears. Additionally, prescribing drops~     postoperatively is a health care cost. The purpose of this study is to determine if there is~     a difference in prevention of tympanostomy tube failure (defined as tube blockage or~     otorrhea) between Otiprio administered once intraoperatively, Ciprodex otic dropgs~     administered once intraoperatively, and Ciprodex otic drops administered intraoperatively~     with a postoperative course.~   "
16769|NCT03347448|"~     This survey was designed as a cross-section study investigation, after the selection,the~     invesgators would adopt the methods of randomly drawing for 100 Beijing female citizens to~     process: questionnaire survey about the skin health, infrared thermal imaging on facing area,~     VISIA skin testing and Germany CK company skin testing etc. for integrated evaluation of skin~     health.~      This survey was designed as a cross-section study investigation, after the selection,the~     invesgators would adopt the methods of randomly drawing for 100 Beijing female citizens to~     process: questionnaire survey about the skin health, infrared thermal imaging on facing area,~     VISIA skin testing and Germany CK company skin testing etc. for integrated evaluation of skin~     health. Analyzing the constitution of volunteers and combining the test related to depression~     and anxious, psychology health evaluated the healthy states. Base on the data collected~     processed the statistic analyzing, comprehensive assessment the impact factor of skin health~     for establishing the Constitution-Psychology-Skin model and though this model to evaluate and~     forecast the skin health problem.~   "
16770|NCT03347435|"~     The antiplatelet agent clopidogrel is an effective drug for the prevention of thrombotic~     events in patients with acute coronary syndromes, and is therefore one of the most frequently~     prescribed drugs worldwide. Accumulating data suggest that the response to clopidogrel is~     characterised by significant inter-patient variability in the degree of platelet inhibition~     and the risk of cardiovascular events. Recent research findings have highlighted the role of~     genetic variations in determining antiplatelet response variability, and this has aroused~     interest in genotyping all thienopyridine-eligible patients in order to identify those who~     would be at increased risk of harm if treated with clopidogrel. This is a prospective,~     multicentre, randomised study enrolling consecutive patients hospitalised because of an ACS~     with or without ST-segment elevation. The patients are randomised to undergo or not tests for~     CYP2C19*2, CYP2C19*17 and ABCB1 3435 genetic variants immediately after diagnosis. The~     genotyping is done using a Q3 System (a compact platform that enables the classic laboratory~     analysis of DNA by means of real-time PCR). The Q3 has been designed as a low entry-cost,~     portable, point-of-care instrument for foolproof use by unskilled personnel. The patients~     randomised to the pharmacogenomic arm receive one of the ADP receptor antagonists~     (clopidogrel/prasugrel/ticagrelor) on the basis of an algorithm that consider genetic and~     clinical variables. The patients randomised to the standard treatment arm receive clopidogrel~     or prasugrel or ticagrelor on the basis of the standard of care (clinical algorithm alone).~     For each patient, a record is made of the occurrence of cardiovascular death, non-fatal MI,~     stroke, BARC-defined bleeding, and definite or probable stent thrombosis. The primary~     endpoint is the composite of death due to cardiovascular causes, non-fatal MI and stroke. The~     secondary endpoints is the occurrence of definite or probable stent thrombosis, and~     BARC-defined major bleeding events (types 3-5).~   "
16771|NCT03347422|"~     The purpose of Part A is to determine whether BIVV009 administration results in a greater~     than or equal to (>=)1.5 gram per deciliter (g/dL) increase in hemoglobin (Hgb) level and~     avoidance of transfusion in participants with primary cold agglutinin disease (CAgD) without~     a recent history of blood transfusion. The purpose of Part B is to evaluate the long-term~     safety and tolerability of BIVV009 in participants with primary CAgD.~   "
16772|NCT03347409|"~     Validation of ERAS interventional measures in elective gynecological surgery, for benign~     either malignant pathology.~   "
16773|NCT03347396|"~     The purpose of Part A is to determine whether BIVV009 administration results in a greater~     than or equal to (>=) 2 gram per deciliter (g/dL) increase in hemoglobin (Hgb) levels or~     increases Hgb to >= 12 g/dL and obviates the need for blood transfusion during treatment in~     participants with primary cold agglutinin disease (CAgD) who have a recent history of blood~     transfusion.The purpose of Part B is to evaluate the long-term safety and tolerability of~     BIVV009 in participants with CAgD.~   "
16774|NCT03347383|"~     The T.I.N.T.I.N. study investigates the safety and efficacy of the combination therapy with~     the Luminor drug coated balloon (DCB) and the iVolution stent in the treatment of TASC C and~     D femoropopliteal lesions. An expected total of 100 patients will be treated in the scope of~     this study. The lesion is located within the native superficial femoral artery and/or the~     popliteal artery. Prior to dilatation with the Luminor DCB, pre-dilatation with the Oceanus~     balloon is mandatory. After dilatation with the Luminor DCB, stenting with the iVolution~     stent need to be performed. Post-dilatation can be performed according to the physician's~     discretion. Patients will be invited for a follow-up visit at 1, 6 and 12 month~     post-procedure. The primary efficacy endpoint of the study is defined as the freedom from~     clinically-driven target lesion revascularization (TLR) at 12 months. Secondary endpoints~     include primary patency rate at 6 and 12 months, freedom from clinically-driven TLR at 6~     months, clinical success at 1, 6 and 12 months and freedom from serious adverse events at~     pre-discharge, 1, 6 and 12 months follow-up.~   "
16775|NCT03347370|"~     The purpose of this study is to investigate the safety of subcutaneous (SC) interferon beta~     therapies with regard to frequency of injection site reactions (ISR) and flu-like symptoms~     (FLS) as reported by the relapsing-remitting multiple sclerosis (RRMS) participants.~   "
16776|NCT03347357|"~     the present study was conducted to assess the population pharmacokinetics of tacrolimus in~     children with nephrotic syndrome and to use these data to calculate an optimal dosing regimen~     of tacrolimus for use in these patients.~   "
16777|NCT03347344|"~     ATRIL is a multi-centric, double-blind randomized, two-arm controlled study. 42~     SpinoCerebellar Ataxia type 2 (SCA2) patients, both gender, at least 18 years of age will be~     included.~      Riluzole 50 mg will be administered (per os) twice a day, versus one group with placebo for~     12 months.~      Riluzole (Rilutek®) is a benzothiazole drug, market approved, for Amyotrophic Lateral~     Sclerosis (ALS). It delays the onset of ventilator-dependence or tracheostomy in selected~     patients and may increase survival.~      Scale for the Assessment and Rating of Ataxia (SARA) will be used at M0, M6 and M12. To~     assess primary criterion, the percentage of patients with a decrease of at least 1 point of~     the SARA score between the inclusion visit, and Visit 3 (Months 12) will be calculated.~   "
23665|NCT03257202|"~     This study is about preventing surgical site infections of the shoulder. We hope to learn if~     clindamycin alone, benzoyl peroxide alone, or clindamycin and benzoyl peroxide together can~     affect growth of Propionibacterium acnes in the dermal layer.~   "
16780|NCT03347305|"~     The daily energy expenditure of patients treated with peritoneal dialysis could be increased~     compared to the general population and promote the development of a state of undernutrition.~     Conversely, the absorption of glucose by transperitoneal route could contribute to the~     occurrence of a metabolic syndrome.~      The main objective is to compare DE and its variations according to the conditions (rest,~     sleep, meals, physical activity) in patients treated with automated DP compared to controls,~     in a calorimetric chamber.~   "
16781|NCT03347292|"~     This study will determine if the combination of regorafenib and pembrolizumab is safe and~     tolerated in patients with advanced liver cancer. In addition, the study will explore the~     anti-tumor activity of this combination as well as potentially identifying blood and tissue~     biomarkers associated with disease activity, status or response. The study will also~     investigate how the drugs behave in your body~   "
16782|NCT03347279|"~     A Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to~     Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents with Severe~     Uncontrolled Asthma~   "
16783|NCT03347266|"~     The purpose of this phase 2 study is to evaluate the efficacy and safety of an analgesic drug~     candidate, VVZ-149 Injections. The study is designed as randomized, double-blind, parallel,~     and placebo-controlled study.~   "
16784|NCT03347253|"~     The purpose of the study is to evaluate changes in key clinical outcome measures (eg, motor,~     respiratory, fatigue) in late-onset Pompe disease (LOPD) subjects receiving standard-of-care~     enzyme replacement therapy (ERT). Additionally, information gained may be used in the design~     and conduct of future studies in LOPD subjects.~   "
16785|NCT03347240|"~     The disability inflected by dystonia encouraged the development of many neurosurgical~     procedures.~      This is a prospective study included 120 patients suffering from intractable secondary~     dystonia.~      They were subjected to different neurosurgical treatments and were assessed through the~     follow up period~   "
16786|NCT03347227|"~     A multicentre, parallel group, two arm, single-blinded randomized clinical trial, assessing~     the efficacy of a patient-tailored catheter ablation (CA) strategy guided by atrial scar~     mapping in addition to pulmonary vein isolation (PVI) when compared to PVI alone in patients~     with persistent atrial fibrillation (AF).~   "
16787|NCT03347214|"~     Background:~      Researchers do not know much about the causes of congenital heart disease (CHD). They do know~     that many factors play a role. Some factors are environmental. Some are genetic. But few~     specific factors have been identified. And researchers do not know how many involve genes.~     They want to study data that has already been collected from people with CHD and their~     families.~      Objectives:~      To identify genetic variations related to CHD. To study molecules related to vascular disease~     in order to learn new ways to treat it.~      Eligibility:~      People who already participated in the Pediatric Cardiac Genomics Consortium (PCGC) study~      Design:~      Researchers will study data that was already collected in the PCGC. There will be no active~     participants.~      Researchers will get access to the data through the coordinating center. They will not~     download data to local storage devices.~      The data will have no personally identifying information....~   "
16788|NCT03347201|"~     In this study, the investigators will be comparing anticoagulation for Cardiopulmonary Bypass~     (CPB) guided by the Hemostasis Management System (HMS Plus) with the current dosing based on~     weight and ACT measurements.~      The primary objective of this study is to determine whether relative to patients with~     conventional management, those managed with the HMS Plus have improved thrombin generation~     after CPB.~      The secondary objective is to determine if patients in the HMS Plus group have reduced blood~     loss in the first 24 hours following surgery compared with patients in the conventional~     group.~   "
16789|NCT03347188|"~     This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group~     study to evaluate the safety and efficacy of fremanezumab in adult patients aged 18 to 70~     years, inclusive, for the prevention of PPTH. Patients will provide written informed consent~     and during study visits they will use an electronic diary application daily, to report their~     headache status and other health information. Efficacy and immunogenicity status will be~     captured periodically and at study termination. The safety will be evaluated through adverse~     event report, concomitant medication inquiries, ECGs, clinical laboratory tests and physical~     examination. Additional evaluations will include pharmacokinetic, biomarker, and~     pharmacogenomics.~   "
16790|NCT03347175|"~     Comparison of three ventilation modes (volume controlled, BIPAP and CPAP) during~     cardiopulmonary re-suscitation with a mechanical compression device in the emergency room.~     Primary aim is to assess mean ventilation volume in the first 15 minutes after randomization.~   "
16791|NCT03347162|"~     PURPOSE: To determine the prognostic properties of a comprehensive evaluation of body~     composition and physical function in patients with GI-HEP cancer from point of diagnosis and~     throughout the treatment trajectory.~      GI-HEP: Patients with tumors of the upper gastrointestinal or hepatobiliary tract,~     specifically tumors of the esophagus, gastro-esophageal junction, stomach, primary tumors of~     the liver or biliary tract, as well as colorectal liver metastasis or tumors of the pancreas.~   "
16792|NCT03347149|"~     This Clinical Study will be conducted as a comparative study focusing on usability and~     efficiency by comparing alarm burden pre- and post- implementation of an Alarm Advisor~     software.~   "
16793|NCT03347136|"~     The objective of the study is to compare the effectiveness of treatment with Non Invasive~     Positive Pressure Ventilation (NIPPV) and continuous positive airway pressure (CPAP) in~     decreasing the requirement for endotracheal ventilation in neonates with respiratory distress~     within the first hours of birth.Primary outcome is the non invasive respiratory support~     failure and the need for intubated ventilatory support during the first 72 hours of life.~      Randomized control , single center trial. Eighty neonates admitted to Neonatal Intensive Care~     Unit (NICU) were randomly allocated to NIPPV and CPAP. Outcomes of respiratory support were~     observed and information on risk factors were obtained by going through bed head ticket.~   "
16794|NCT03347123|"~     The purpose of this study is to determine the safety, tolerability, and efficacy of~     epacadostat when given in combination with nivolumab and ipilimumab, and in combination with~     nivolumab and lirilumab, in subjects with advanced or metastatic malignancies.~   "
16795|NCT03347110|"~     This is a study to assess the long-term safety and tolerability of bimekizumab in subjects~     with psoriatic arthritis~   "
16796|NCT03347097|"~     At present, the investigators constructed a transgenic modified T cells,namely pluripotent~     immune killer (PIK) cells, the cells can stablely express a high-level full-length PD1~     antibody , transduce signals to activate T cells, which results in tumor killing. This pilot~     study is to determine the safety and efficacy of autologous T cells in patients with~     glioblastoma.~   "
16797|NCT03347084|"~     The purpose of the proposed study is to determine the feasibility of brief brain stimulation,~     using a device called Low Intensity Focused Ultrasound Pulsation (LIFUP), for persons with~     mild cognitive impairment (MCI) or mild (early-stage) Alzheimer's disease (AD). As a~     secondary aim, the investigators will explore whether this brief intervention is associated~     with improvements in cognitive functioning immediately and one week following the~     intervention.~      Subjects will be randomly assigned to one of two experimental groups: either the LIFUP~     administration will be designed to increase the activity of neurons in a certain part of the~     brain or decrease the activity of neurons.~      The investigators will study up to 8 subjects with MCI or mild AD. Initially, subjects will~     undergo a screening assessment with a study physician to determine medical and psychiatric~     history, establish AD diagnosis, and undergo a blood draw, if standard recent labs for~     dementia and EKG are unavailable. Subjects that meet criteria and agree to participate in the~     study will undergo a follow-up visit. In the baseline measurement visit, participants will~     first undergo neuropsychological testing. Participants will be randomly assigned to one of~     two LIFUP pulsing paradigms. Participants will then be administered four successive LIFUP~     treatments while the participants are in a functional magnetic resonance imaging (MRI). Sixty~     minutes following the administration, participants will undergo a second neuropsychological~     test. A final follow-up assessment will be administered at one week.~   "
16798|NCT03347071|"~     The purpose of the study is to evaluate effects of a 7-week undergraduate course,~     incorporating Eat Breathe Thrive program curriculum, offered to female student-athletes in~     order to increase positive body image, emotional regulation, interoceptive awareness,~     self-care skills, and intuitive eating. The undergraduate course is structured around the Eat~     Breathe Thrive program curriculum, which aims to: a) teach somatic practices that increase~     interoceptive awareness, b) provide healthy tools for emotional regulation, c) allow for the~     creation of community-based networks of support, and (d) foster a sense of meaning and~     purpose through service activities. In a non-randomized controlled trial, the investigators~     plan to examine whether this preventative undergraduate course is found effective in a female~     student-athlete population in preventing and decreasing eating disorder risk. The~     investigators also plan to examine whether the program is found effective in increasing~     protective factors, such as self-care behaviors, interoceptive awareness, intuitive eating,~     and emotional regulation skills.~   "
16799|NCT03347058|"~     As usage and indications for immunotherapy (IO) increase, there presents a critical need to~     identify patient-centered and practice solutions across the continuum of care. Immunotherapy~     & Me is an innovative program of customizable resources that seeks to improve the patient~     experience by supporting the unique needs of both IO patients and the clinical staff who care~     for them. Cancer Support Community (CSC) will implement this operational framework of patient~     and provider tools at nine geographically and demographically diverse oncology practices. At~     the end of year one, CSC will evaluate program impact, retool interventions as necessary, and~     pursue additional funding with the goal extending services at existing practice sites - and~     scaling this turnkey model of IO treatment support.~   "
16800|NCT03347045|"~     Trimodal prehabilitation is a preoperative three-tiered (trimodal) approach to optimizing~     physical and mental health. It has been found to successfully improve functional recovery in~     patients undergoing colorectal surgery following an evidence-based enhanced-recovery pathway~     (ERP). It is unknown whether the same program is effective in patients undergoing a similar~     surgery for bladder cancer (radical cystectomy).~      Objective: To evaluate the appropriateness of a standardized prehabilitation program for~     implementation into an enhanced recovery pathway for cystectomy patients and determine~     whether prehabilitation facilitates earlier recovery of functional capacity.~      Hypothesis: Prehabilitation will ultimately improve recovery of functional capacity, clinical~     and patient-centered outcomes in patients undergoing radical cystectomy for bladder cancer.~      Design: Participants will follow an 8-week trimodal prehabilitation program consisting of~     exercise therapy combined with nutritional counseling, protein supplementation, and~     psychological care; they will be compared to a cohort of participants following ERP care~     alone.~      Conclusion: The proposal will provide insight into the feasibility and effectiveness of~     trimodal prehabilitation for radical cystectomy patients and may ultimately lead to improved~     clinical outcomes and reduced morbidity.~   "
16801|NCT03347032|"~     Severe aortic stenosis remains a major cause of morbidity and mortality of the elderly~     affecting approximately 3% of elderly patients with an increasing number of patients~     undergoing transcatheter aortic valve interventions. As part of pre-procedural planning these~     patients undergo CT scans and receive contrast during the procedure. These patients often~     have baseline renal insufficiency and are high risk of contrast induced nephropathy despite~     pre-hydration techniques. The purpose of this study is to evaluate the efficacy of this~     simple and safe procedure in preventing renal injury in this particular population.~   "
16802|NCT03347019|"~     The aim of this study was to prospectively evaluate the efficacy of an accelerated~     rehabilitation regime for patients undergoing early arthroscopic stabilization for first-time~     anterior dislocation in terms of clinical outcome, return to play data and recurrence rates.~   "
16803|NCT03347006|"~     A randomised, double-blind, placebo-controlled study to determine whether fish oil~     supplementation regulates peripheral levels of specialized pro-resolving mediators and white~     blood cell responses in healthy volunteers~   "
16804|NCT03346993|"~     Brachial plexus blocks have some advantages, but also have some disadvantages as well. As~     with all nerve blocks, having to wait sometime for an effective block, sometimes failure to~     achieve an adequate block and possible requirement for isolated nerve block, having to wait a~     long time for resolution of the block, and immobilization of the extremity for some time can~     be seen as handicaps for brachial plexus block as well. In the present study, Study was aimed~     to compare the effects of bupivacaine warmed to body temperature and kept at room temperature~     on the onset time of ultrasound guided infraclavicular brachial plexus block.~   "
16805|NCT03346980|"~     Familial adenomatous polyposis (FAP) is an autosomal dominant genetic disorder that~     predisposes to a number or malignant disorders [1,2]. Clinically, FAP presents with an~     abnormal number of colorectal polyps (100-5000), while it genetically is defined by mutations~     in the APC-gene [1]. Historically, colorectal cancer has been the major cause of deaths for~     FAP patient. However, as the incidence of colorectal cancer has decreased with the use of~     prophylactic colectomy, the incidence of duodenal cancer has increased [3,4]. It is estimated~     that the cumulative lifetime risk of duodenal polyposis exceeds 95% [1,5]. The predictor of~     duodenal cancer is duodenal polyposis, which is almost inevitable in patients with FAP.~      In 1989 the Spigelman score was introduced in order to assess the severity of duodenal~     polyposis and stratify patients according to risk of duodenal cancer (Table 1) [6]. It is a~     composite score that includes two endoscopic parameters (number and maximum size of polyps,~     respectively) and two histopathological parameters (histological subtype and grade of~     dysplasia). The score ranges from 0-12 and it has been classified in four stages. The 10-year~     risk of developing duodenal cancer corresponds with the Spigelman stage ranging from ≈0 for~     stage 0-1 to 36% for stage 4 [7]. Besides duodenal cancer, the indications of cancer~     prophylactic surgical resection are debatable, but generally recommended in the case of~     Spigelman stage 4 or high-grade dysplasia.~      Table 1 Spigelman Classification for duodenal polyposis Criterion 1 point 2 points 3 points~     Polyp number 1-4 5-20 >20 Polyp size (mm) 1-4 5-10 >20 Histology Tubular Tubulovillous~     Villous Dysplasia Low grade* High grade* Stage 0: 0 points; stage I: 1-4 points; stage II:~     5-6 points; stage III: 7-8 points; stage IV: 9-12 points. *Originally, 3 grades of dysplasia~     were incorporated.~      While the correlation to cancer has been explored in several studies, the validation and the~     reproducibility of the Spigelman score remains somewhat unclear. The primary aim of this~     study is to assess the inter- and intra-observer agreement of the Spigelman score for~     experienced endoscopists using state-of-the-art high-definition (HD) endoscopes.~      Hypothesis: The Spigelman score has perfect reproducibility for endoscopic experts (κ>0.80~     with 95% CI.).~   "
16806|NCT03346967|"~     The purpose of this study is to evaluate the safety and effectiveness of adipose derived~     mesenchymal stem cells (AD-MSCs) therapy on sexual hormone deficiency in the middle-aged~     patients~   "
16807|NCT03346954|"~     Cushing's disease is characterized by the existence of a benign pituitary tumor developed~     from corticotropic cells responsible for excessive ACTH secretion. This results in~     hypercorticism causing high morbidity and mortality and severely impairing quality of life.~     The etiological diagnosis is based on Magnetic Resonance Imaging (MRI). However, pituitary~     MRI revealed a pituitary tumor in only 60% of patients. The diagnostic procedure is~     complicated by the existence of extra pituitary tumors responsible for ACTH ectopic~     secretion. This rare etiology imposes, in the absence of typical pituitary image, the~     realization of catheterization of the lower petrosal sinuses. Treatment of Cushing's disease~     is based on transsphenoidal surgical management, even in the absence of a formal MRI image,~     if pituitary origin is confirmed by the catheterization. Although pituitary surgery without~     identified target is part of French recommendations, this surgery is associated with a high~     risk of failure and morbidity. Optimization of the management of patients' with Cushing's~     disease thus requires the improvement of the diagnostic methods.~      Hypothesis of our study is that [11C] MET MRI-PET may be performed as a first-line MRI for~     suspected Cushing's disease and may limit indications for catheterization of lower petrosal~     sinuses. Its localizing value should also make it possible to improve the surgical results~     with a better identification of the adenoma~   "
16808|NCT03346941|"~     The objective of this study was to assess the incidence of side effects after direct-acting~     antiviral therapy in patients with chronic hepatitis C virus infection.~   "
16809|NCT03346928|"~     The objective was to evaluate perioperative morbidity after head and neck microsurgical~     reconstruction.~   "
16810|NCT03346915|"~     The project aims to increase HPV vaccination and cervical cancer screening through a~     web-based mobile health education program called, Wheel of Wellness (WoW) and a brief~     negotiated interview (BNI). The in-person BNI and WoW system will provide educational~     resources for participants and their families to learn more about HPV vaccination and~     cervical cancer screening.~   "
16811|NCT03346902|"~     This study will evaluate the safety and efficacy of EB-001 in improving wound healing and~     reducing scar formation in patients undergoing Mohs surgery for skin lesions in the forehead~     area following a single treatment of EB-001 when injected into the muscles underlying the~     incision area.~   "
16812|NCT03346889|"~     Previous studies have shown that vertigo is the symptoms that mostly affect quality of life~     in patients with vestibular schwannoma. There is still limited knowledge as to why some~     patients with this disorder develop vertigo, while others with the same diagnosis do not. The~     purpose of this study is to measure symptom-related quality of life and to relate this to~     objective disease characteristics at baseline.~   "
16813|NCT03346876|"~     Investigators conducted a pilot study to to evaluate the autonomic function in participants~     with pectus excavatum before and after Nuss surgery.~   "
16814|NCT03346863|"~     In patients with persistent atrial fibrillation (AF), electrical cardioversion is very~     effective in restoring sinus rhythm if modern, biphasic cardioverters are used. However,~     approximately 50 per cent of the successfully cardioverted patients experience a recurrence~     of AF within a few weeks. Therefore, valid predictors for AF recurrence would be of great~     clinical relevance, to avoid unnecessary procedures.~      In the PRE-ELECTRIC study, we will investigate the predictive value of potential new~     biomarkers with respect to AF recurrence within 30 days after electrical cardioversion. We~     will investigate serum and plasma biomarkers, electrocardiological markers and~     echocardiographic variables in this respect. The study will be undertaken as a prospective~     cohort study at Bærum Hospital, Vestre Viken Hospital Trust, with national and international~     collaborators.~   "
16815|NCT03346850|"~     The purpose of the study is to compare two ways (nasogastric tube (NGT) and nasoduodenal tube~     (NDT)) to provide nutrition to infants admitted to the hospital for viral bronchiolitis and~     who require high flow nasal cannula therapy.~   "
16816|NCT03346837|"~     Assess the effects of itraconazole and rifampin on the pharmacokinetics, safety, and~     tolerability of BMS-986205.~   "
16817|NCT03346824|"~     Failure of Weaning from ECMO is a serious complication, reaching an incidence between 29 and~     58%. Inotrops are frequently used to help separating patient from ECMO. Levosimendan is an~     ino-dilatatory medication and was used in different clinical settings. The aim of this study~     was to evaluate the benefit with levosimendan when used in weaning process.~   "
16818|NCT03346811|"~     this single arm，open-label，multi-center study is aimed to evaluate the efficiency of icotinib~     in plasma ctDNA EGFR mutation-positive patients diagnosed with lung cancer~   "
16819|NCT03346798|"~     This project aims to explore how social media use, in particular food photography, influences~     eating behaviours. It will be approached through three methods - a correlational experience~     sampling method, an experimental experience sampling method, and an experimental laboratory~     method. This registration describes the experimental laboratory method.~   "
16820|NCT03346785|"~     This project aims to explore how social media use, in particular food photography, influences~     eating behaviours. It will be approached through three methods - a correlational experience~     sampling method, an experimental experience sampling method, and an experimental laboratory~     method. This registration describes the experimental experience sampling method.~   "
16821|NCT03346772|"~     Better understanding of the immune responses to influenza vaccination is needed in order to~     understand situations of poor vaccine response. Adults will receive influenza vaccination and~     then have peripheral blood drawn at pre-defined intervals in order to study the lymphocyte~     responses.~   "
16822|NCT03346759|"~     The vaginal microbiota is the community of bacteria in the vagina. The composition of the~     vaginal microbiota (which bacteria are present and how many of each are present) is known to~     affect vaginal health and contribute to the development of bacterial vaginosis (the largest~     cause of vaginal discharge and malodor, and the most common vaginal disorder). It is also~     known that the composition of the vaginal microbiota changes across a menstrual cycle with~     the largest changes happening during a woman's period. However, it is not know how tampon use~     affects vaginal microbiota composition. This study is being done to learn what effect tampon~     use has on vaginal microbiota composition during a woman's period and between periods.~   "
16823|NCT03346746|"~     This study provides participants with two diets that vary in their glycaemic index values~     (low vs. high), whilst also measuring cognitive performance and mood.~   "
16824|NCT03346733|"~     Serum cholesterol is a major modifiable risk factor for cardiovascular disease, which despite~     considerable reduction in prevalence, remains the leading cause of premature mortality~     worldwide. Although LDL-C continues to be recognized as the primary therapeutic target,~     accumulating evidence suggests that alternative lipid parameters, non-HDL-C and apoB, may~     provide predictive value beyond that of LDL-C alone, in most population categories. Numerous~     lifestyle strategies have been developed to manage elevated cholesterol concentrations, of~     which viscous fibre is often encouraged for its beneficial effects on LDL-C reduction.~     Conversely, the effects of viscous fibre on new lipid markers, non-HDL and apoB, have yet to~     be defined. Therefore, this study seeks to elucidate the therapeutic potential of psyllium~     fibre on totality of atherogenic cholesterol and lipoprotein particles in a systematic review~     and meta-analysis of randomized controlled trials.~   "
16825|NCT03346720|"~     In recent years, Mahidol Oxford Tropical Medicine Research Unit (MORU) has coordinated some~     of the largest international studies involving many sites in low-income and hard-to-reach~     settings. It has been our policy for many years to support sharing of data across~     collaborative research networks in order to maximize their utility. However there is~     increasing support from research funders, regulatory agencies and journals for sharing~     individual-level data from genomic, medical and public health research beyond research~     collaborations. A number of potential advantages of sharing individual level data from~     clinical and public health research have been identified in the literature. These include~     maximizing the utility of data, allowing verification of research results, and minimizing the~     burdens and costs of unnecessary duplication of research. In low- and middle-income settings~     it may be particularly important to effectively share data to maximize its utility and enable~     timely responses to important public health issues such as resistance to antimalarial~     treatments. Many authors have called for data sharing to be carefully curated, to minimize~     potential harms including breaches of privacy, the publication of poor quality or biased~     secondary research, and insufficient acknowledgment of the contribution of researchers~     generating datasets. In low- and middle-income settings, the need for data sharing policies~     and processes to promote equitable use of data, including the development of sustainable~     capacity to both share and analyse datasets, has been recognized.~      It is foreseeable that the impact of this policy will be significant both practically and~     ethically. In the practical sense, there have already been changes in our data management~     processes and resources, clinical trial agreements and negotiations with collaborators.~     Ethically, this policy has impact on the consent process which includes the increasing use of~     broad consent, the changes in the language of information sheets, study protocols and ethics~     application documents and the actual consent taking by research staff.~      Now that that these new data-sharing mechanisms have been put in place there is a need to~     evaluate their impact on practice. The aim of this study is to identify and analyse ethical~     challenges related to consent following implementation of a new data sharing policy with the~     aim of refining the data sharing policy and its related consent processes~   "
16826|NCT03346707|"~     This unique NMR instrument is the first of its kind, and the most advanced system that is~     capable of brain, torso and extremity imaging in humans at such a high magnetic field. It~     will be transformative in performance relative to 7Tesla, and significantly expand the~     capabilities of multinuclear MRI, fMRI, morphological imaging, MRS etc. in the human brain~     and body.~      In addition, to the known and potential benefits of performing anatomic and functional~     imaging studies at 10.5T, there are also known short-term side effects associated with~     subjecting humans to such high magnetic fields. This protocol will study the magnitude and~     variability of the short term and long term physiological, cognitive and vestibular effects~     while also assessing the feasibility of acquiring the types of data needed for translating~     research protocols onto this higher field strength scanner.~   "
16827|NCT03346694|"~     This study will evaluate two alternative dressings compared to a standard Island dressing~     presently in use at Stanford Hospital to determine reductions in surgical site infection~     (SSI) rates among cardiac surgery patients. Cardiovascular surgery patients who will have a~     sternotomy incision as a routine part of their surgery will be approached to voluntarily~     participate. Participants will be randomized to one of three dressing to determine which~     dressing has the lowest rate of sternal wound infection. The investigators will also assess~     the impact of alternative dressing use on hospital 30-day readmission rates related to SSI.~   "
16828|NCT03346681|"~     We would study whether there is any measurable benefit of the administration of nebulized~     n-acetyl-cysteine to acute respiratory distress syndrome patients starting within 48 hours of~     intubation and mechanical ventilation.~   "
16829|NCT03346668|"~     This study will serve as a pilot study to determine the efficacy and safety of topical~     gabapentin in the treatment of symptomatic scarring alopecia.~   "
16830|NCT03346655|"~     The overall aim and primary outcome of this study will be a descriptive analysis of the~     current treatment practice of BM in Norway. Specifically, it may give answers to the~     following research questions:~        -  What is the true incidence of BM in Norway?~        -  How are patients with BM treated at present?~        -  Do treatments differ between hospitals?~        -  How do treatments impact quality of life of the patients?~        -  Which factors (treatment, tumor and host variables) can explain disease control,~          survival, symptom relief, and general functions?~        -  How can BM staging be improved?~   "
16831|NCT03346642|"~     In this study, participants with relapsed or refractory primary mediastinal large B-cell~     lymphoma (rrPMBCL) will receive GVD (Gemcitabine, Vinorelbine and Doxorubicine) chemotherapy~     and PD-1 antibody（SHR-1210） with or without low-dose Decitabine priming. The safety and~     feasibility of combined regimens will be evaluated in phase I study. The subsequent phase II~     study will access the efficacy of the combined regimens.~   "
16832|NCT03346629|"~     This study seeks to evaluate the safety, acceptability and feasibility of an outpatient day~     procedure for medical abortion at 13-18 weeks gestation. The study regimen will consist of a~     single dose of 200 mg mifepristone to be taken orally either at home or at the hospital,~     followed approximately 24 - 48 hours later with administration of 400 mcg misoprostol. Repeat~     doses of 400 mcg (two tablets) of misoprostol will be administered buccally every three hours~     until the abortion is achieved.~   "
16833|NCT03346616|"~     In this study, third year medical students on the pediatric clerkship will be randomized to~     receive either only written educational material (review journal articles) or written~     educational material plus daily text messages consisting of board style questions with online~     answers. The students' performance on the National Board of Medical Examiners (NBME)~     Pediatric Subject Evaluation will be compared between the two groups.~   "
16834|NCT03346603|"~     Between 2013-2014, our study network of U.S. emergency departments, EMERGEncy ID NET, found~     that the rate of fluoroquinolone-resistant E. coli was 11.7% among all patients, 6.3% in~     uncomplicated and 19.9% in complicated. ESBL-producing Enterobacteriaceae were found in 7.7%~     of all cases, 2.6% in uncomplicated and 12.2% in complicated. More recently,~     Enterobactericeae and gram-negative non fermenting bacteria have started to show resistance~     to carbapenems (CREs and CR-NF). Patients hospitalized with UTI and urosepsis represent a~     higher risk population for infections due to multi-drug resistant bacteria and experience~     serious adverse outcomes, including death. EMERGEncy ID NET will conduct a study to determine~     the prevalence of ESBL-producing, CREs and CR-NFs among this high risk population of patients~     admitted for UTI from U.S. emergency departments.~   "
16835|NCT03346590|"~     Chronic inflammation in rheumatoid arthritis is associated with adiposity, sarcopenia,~     cachexia, reduced activity due to functional impairment, and anti-inflammatory drugs.~     Patients frequently gain weight when taking anti-tumor necrosis factor (TNF) medication,~     prompting questions about the underlying mechanism and long-term cardiovascular and metabolic~     tolerance associated with these drugs The primary objective of this study is to analyze the~     impact of anti-TNF treatment during the first year of administration on the energy metabolism~     of patients suffering from RA, assessed as an absolute value (before-after) and in comparison~     with a standard measured in healthy matched subjects.~   "
16836|NCT03346577|"~     The purpose of this observational study is to evaluate the performance and safety of~     endovascular treatment with stenting (Optimed Sinus Superflex 635) or balloon angioplasty~     (Cardionovum Legflow or Optimed Nylotrack .035 + .018) according to current practice. The~     goal of the study will be achieved by assessing binary restenosis with duplex ultrasound,~     peri- and postoperative complications, technical success, target lesion revascularization,~     amputation and clinical outcome.~   "
16837|NCT03346564|"~     To evaluate the effects of a ritual training program in head and neck cancer (HNC) patients.~   "
16838|NCT03346551|"~     The specificity of postnatal depression (PND) was acted as full entity within the~     depressions, by B. Pitt in 1968, through the description of a specific nosography which~     describes an atypical depression of the post-partum .~      Actually, the epidemiological studies agree on prevalence from 10 to 15 % of PND. With two~     peaks of frequency, the first one around the 6th and 12th week comment native and the second~     during the second half-year. This rate of PND represents in France 75000 to 100000 women a~     year.~      The professionals of the perinatal period are interested in this disorder because of the~     consequences for the woman herself, and of the impact on the premature interactions~     mother-baby. These interactions and the direct effects of the PND on the mother will have for~     influence an important slowing down on the development of the baby. Moreover, the study of~     Lemaitre and Candilis in 1999, brings the figure of 15 % of the PND which will have an impact~     on the development of the baby.~      The sensation of the depression testifies of a process of change and of psychic conflict~     favored by the psychic transparency of the pregnancy.~      Although the first treaty on this specific nosography dates more than 150 years of numerous~     questions stay suspends it.~      These questions and the reflections which surround them found on their path tools ensuing~     from the theory of the attachment, formalized by John Bowlby. For more than three decades,~     these profiles of attachment, specified by Mary Ainsworth: secure, anxious-ambivalent,~     anxious-avoided and disorganized later, disrupted, is studied, estimated and their evolution~     during a life is observed. Thanks to these models well known for the same person at a time t,~     it is now their effects in the interpersonal relations which are studied. Between the people~     but also on the person himself, its image of her, and its autobiographical memory.~      The autobiographical memory represents a central component of the human memory. At a very~     general level, it's possible to define it as the capacity of a person to remember its past~     experiences. The review of the literature on the functioning of the episodic autobiographical~     memory during the depression highlights three main results: the too bi generalization of the~     memories, the congruence in the humor and the frequency of the intrusive memories~     characterized by an involuntary reminder, fast and effortlessly (Lemogne and al., 2006;~     Lemogne and al., 2012). The authors specify that there are links between strategies of~     avoidance of the intrusive memories and the phenomenon of generalization. These links ask to~     be explored within a model integrating, self and episodic autobiographical memory in the~     field of the depression. The use of the memories defining the one could allow to study more~     specifically this kind of memories. The memories defining the one were introduced to Ape and~     Moffitt (1991) to characterize a specific category of autobiographical memories. The memories~     defining the one are important personal memories which help a person to understand whom this~     person is as individual. In a way, they build the life story and support the personal~     identity. Connected to other similar memories, the self-defining memories contain numerous~     sensory details and are often associated to a strong emotional charge. They are also~     connected to long-term purposes, to concerns or to unsolved conflicts.~      Recent studies used the self-defining memories (French version adapted by Mr van der Linden's~     team, Switzerland) as tool to understand better the psychological disorders from which~     certain people suffer. The studies show that the self-defining memories undergo modifications~     the characteristics of which are in connection with every pathology (works of the team of~     J.M. Danion).~      In 1994, Moffit and al. studied a group of students with evaluation of the depressive~     symptomatology. They established that the presenting subjects of high scores of depression~     develop more generalized memories than the other participants when is asked to them a~     self-defining memorie positive. For the memories with negative valence, no difference is~     found among the tested students. There are no data in the literature on the self-defining~     memories and the postnatal depression. Besides, there is only a single search, not published~     which explores the links between the attachment and the memories defining the one (Tagini,~     Conway and Meins, looks for not published, quoted by Conway, to Ape and Tagini, on 2004). The~     authors present the results according to the styles of attachment. So, autobiographical~     memories would vary according to the cognitive and emotional dimensions, in connection with~     differences in the style of attachment. In every style of attachment would correspond certain~     specificities in the contents and in the form of the self-defining memories.~   "
16839|NCT03346538|"~     To investigate the efficacy and safety of MCI-186 (bolus followed by continuous infusion) in~     acute ischemic stroke patients through a double-blind, parallel-group comparison with the~     existing MCI-186 dosing regimen (administration twice daily for 14 days) as the control.~   "
16840|NCT03346525|"~     Rheumatic heart disease (RHD) affects at least 32.9 million people, mostly children living in~     low-resource settings. Long-term intramuscular benzathine penicillin G (BPG) prophylaxis is~     proven to prevent progression of chronic valve changes in patients with established rheumatic~     heart disease (RHD) and to allow regression of valve changes in patients with a history of~     acute rheumatic fever (ARF) with mild RHD. However, in low-resource settings ARF is an~     elusive diagnosis, and most patients (85%) are diagnosed only when RHD is severe and~     irreversible, medications ineffective, and surgical intervention is expensive and/or~     unavailable.~      Identification of latent RHD might be an opportunity to substantially reduce RHD morbidity~     and mortality. However, detection of latent RHD is only important if outcomes are improved.~     The appropriate management of children with latent RHD is unknown and no formal~     recommendations exist. While some clinicians prescribe penicillin prophylaxis for children~     with latent RHD, clinical equipoise exists regarding the best practice.~      To fill this gap, the investigators propose a randomized controlled trial in children with~     latent RHD to evaluate the efficacy of BPG prophylaxis compared to no prophylaxis. Our~     primary outcome measure is progression of valvular changes on echocardiogram at 2 years. A~     sample size of 916 children is needed to detect a 50% reduction of progression (expected~     range 7.5-12.5% progression in BPG-arm vs. 15%-25% progression in control-arm) with 90%~     power.~      AIM 1: To compare the proportion of children (aged 5-17 years) with latent RHD receiving BPG~     prophylaxis who progress to worse valvular disease at 2-years compared to children not~     receiving BPG prophylaxis.~      Hypothesis 1: Prophylaxis with BPG will result in fewer children with latent RHD showing~     progression of echocardiographic valve changes at 2 years compared to children with latent~     RHD not receiving BPG prophylaxis. (The investigators expect at least a 50% relative~     reduction in progression in the BPG arm: range 15%-25% control arm vs. 7.5-12.5% BPG-arm.)~      AIM 2: To compare the proportion of children (aged 5-17 years) with latent RHD receiving BPG~     prophylaxis who regress to improved valvular disease at 2-years compared to children not~     receiving BPG prophylaxis.~      Hypothesis 2: Prophylaxis with BPG will result in more children with latent RHD showing~     regression of echocardiographic valve changes by 2 years compared to children with latent RHD~     not receiving BPG prophylaxis. (The investigators expect at least a 50% relative increase in~     regression in the BPG arm: range 10-20% control arm vs. 20-40% BPG arm.)~      This study is highly significant because it will establish if BPG prophylaxis improves~     outcomes for children with latent RHD. Feasibility will be ensured through the experience,~     resources, community support, and accessible patient population of our investigational team.~     The results of our study will have high impact, immediately informing international policy on~     the standard of care for children diagnosed with latent RHD and shaping, over 2-3 years,~     practical and scalable programs that could substantially decrease the global burden of RHD.~   "
16841|NCT03346512|"~     This is a retrospective observational study of the transfusion threshold in cardiac surgery.~      There is controversy in the literature regarding the transfusion threshold to be adopted,~     especially in a patient who has undergone cardiac surgery. Some authors suggest that the~     transfusion should be done in a restrictive way when a certain threshold in hemoglobin is~     reached, in order to avoid the risks it implies, especially infectious.This threshold is very~     controversial and remains to be defined (variations in the literature from 7g / dL to 9g /~     dL). Other authors conclude that there is no superiority of a restrictive transfusion~     compared to a more liberal transfusion, with regard to the morbidity or medical costs.~      It is therefore interesting to study, in a retrospective manner, the global and~     multidisciplinary management of patients who have undergone a cardiac surgery within the CHU~     Brugmann hospital, to analyze if they have been adequately transfused.~   "
16842|NCT03346499|"~     This is a pilot study of the infusion of haploidentical NK cells with IL-2 in 5 HIV+~     individuals who are on stable ART with full HIV suppression.~   "
16843|NCT03346486|"~     To evaluate the effect of dietary intervention on metabolic risk profile, and on potential~     simultaneous changes in physiological and cognitive functions and to collect a unique~     database using state-of-the-art technologies on variables related to the above mentioned~     areas.~   "
16844|NCT03346473|"~     Individual-participant data analysis of the Global School-Based Student Health Survey and~     Health Behaviour in School-Aged Children surveys in 57 LMICs between 2003-2013.~   "
16855|NCT03346330|"~     This is an exploratory, randomised, double-blind, placebo-controlled, Phase I study to assess~     the safety, tolerability, pharmacokinetics, pharmacodynamics and food-effect of single and~     multiple, ascending oral doses of TRK-750 in healthy adults and patients with peripheral~     neuropathic pain.~   "
16845|NCT03346460|"~     Halitosis, also known as bad breath, is a term used to define an unpleasant and foul odor~     that emanates from the mouth and may have local or systemic origin. This project aims to~     observe the presence of halitosis and to verify if the treatment with antimicrobial~     photodynamic therapy (aPDT) is effective against it. The investigators will select 45~     students or UNINOVE employees, from 18 to 25 years old, with a diagnosis of halitosis,~     presenting sulfite (SH2) ≥ 112 ppb on gas chromatography. Patients will be randomly divided~     into 3 groups of 15, which will receive different treatments: Group 1: treatment with tongue~     scraper; Group 2: aPDT applied in the back region and middle third of the tongue; Group 3:~     combined treatment of tongue scraper and aPDT. For the aPDT we will use urucum manipulated in~     the concentration of 20% (Fórmula e Ação®) in spray, to be applied in sufficient quantity to~     cover the middle third and back of the tongue (5 sprinkles) for 5 minutes for incubation,~     associated with a LED (Valo Cordless Ultradent®). 6 points will be irradiated on the back of~     the tongue with a distance of 1 cm between the points, considering the halo of light~     scattering and effectiveness of aPDT. The apparatus shall be precalibrated at wavelength~     440-480nm for 60 seconds per point, irradiance of 450mW/cm and the light shall be irradiated~     so that a halo of 2cm diameter is formed per point. The results of the halimetry will be~     compared before and immediately after the treatment, besides the microbiological analysis of~     the tongue coating, before and after the treatment. The normality of the data will be~     measured using the Shapiro-Wilk test, and in the case of normality the Variance Analysis~     (ANOVA) test will be applied, and in the case of non-parametric data, the Kruskal-Wallis test~     will be used. To analyze the results of each treatment in both periods of the study, the~     Wilcoxon test will be used.~   "
16846|NCT03346447|"~     This is a single-center, prospective, single-blind pilot study to determine baby wipe~     formulations on an adult dermatitis model.~   "
16847|NCT03346434|"~     This study is a 2-part (parts A and B) phase 2/3 study to evaluate the safety,~     pharmacokinetics (PK) and efficacy of dupilumab in patients 6 months to less than 6 years of~     age with severe atopic dermatitis (AD).~   "
16848|NCT03346421|"~     Obesity is currently considered an increasingly more severe social and health related~     problem. The World Health Organization qualified obesity as a chronic disease along with~     circulatory diseases, diabetes, cancer and respiratory diseases. The principal physiological~     methods of treatment for this disease are diet and exercise. The aim of the study is assess~     anhtropometric parameters, metabolic and proteomic profile and respiratory truck function in~     obese patients reducing body weight during 21 days course of calorie restriction and physical~     activity.~   "
16849|NCT03346408|"~     The identification of an addiction to opioid analgesics has become strong recommendation for~     the purpose of improving the clinical management of the patients. However, the success of the~     patient's clinical management, in terms of analgesia and treatment of drug dependence, rests~     on the acceptance of this management by the patient himself. The main objective of this study~     is to evaluate the factors associated to the discrepancy between the assessment of dependence~     on analgesic drugs by the algologist and the perception that the patient with non-cancer~     chronic pain has of this dependence.~   "
16850|NCT03346395|"~     Problem solving based intervention involving the workplace has shown promising effects on~     return-to-work among persons with common mental disorders. A key element is cooperation~     between the person on sick leave, the participant's employer and health care professionals.~     The aim of the present study is to evaluate the effects of a problem solving based~     intervention in the Swedish primary health care system on an employed population on sick~     leave due to common mental disorders. Cluster randomized controlled trial. The investigators~     hypothesize that:~      Participants who have undergone the work-related problem solving based intervention will have~     fewer total days on sick leave than the participants who receive treatment as usual at 18~     months.~      Participants who receive the work-related problem solving based intervention will have fewer~     recurrent periods of sick leave than the participants who receive treatment as usual at 18~     months.~      Participants who receive the work-related problem solving therapy intervention will score~     better on the secondary outcomes than the participants in the control group.~      Population: Employed, aged 18 - 59, on short-term sick leave (min. 2 - max. 12 weeks) due to~     common mental disorders.~      Intervention: Work-related problem solving based intervention in addition to treatment as~     usual. The intervention will be given by rehabilitation coordinators on max. five occasions~     and includes: making an inventory of problems and/or opportunities related to return-to-work;~     identifying the support needed to implement the solutions; a meeting with the person on sick~     leave, his/her employer and the rehabilitation coordinator to discuss solutions; making an~     action plan and evaluation.~      Control: The control group will receive care as usual (i.e. cognitive behavioral therapy~     and/or medical treatment, and meeting with a rehabilitation coordinator if this is a part of~     care as usual at the primary health care centre). A total of 220 persons on sick leave and 30~     rehabilitation coordinators will be included.~      Primary outcome: total number of days on sick leave at 18 months after baseline. A parallel~     process evaluation will be conducted to examine: to what extent it is possible to implement~     problem-solving therapy according to the protocol; the relationship between the key elements~     of problem-solving intervention and the effect outcome; how the participants perceive the~     intervention.~   "
16851|NCT03346382|"~     Retrospective data analysis, all emergency medical services of the city of Zurich~     interventions due to epileptic convulsions during June 2013 and December 2014 have been~     analyzed regarding the type of drug used, its application mode and the application mode based~     success. Furthermore, children versus adults were compared. Continuous variables were~     summarized as mean ± standard deviation (SD) and also presented as median [minimum; maximum].~     Groups were compared using the independent samples t-test. P-values < 0.05 are considered~     significant.~   "
16852|NCT03346369|"~     This study investigates the efficacy and the safety of Lanthanum Carbonate for the reduction~     of urinary oxalate excretion in patients with secondary hyperoxaluria and nephrolithiasis.~   "
16853|NCT03346356|"~     In close collaboration with the Nevada County 4-H Youth Development Program, the Shaping~     Healthy Choices Program was implemented utilizing 4-H teenagers as cross-age teachers for~     younger youth. The 4-H Youth Development Program is an education program of the University of~     California Cooperative Extension that emphasizes learning citizenship, leadership, and life~     skills. The program creates positive opportunities for youth to learn, develop skills, and~     become engaged in their local communities. This is accomplished with combined efforts of~     youth, volunteer leaders, and University staff and faculty through a fun, hands-on learning~     approach to non-formal education. As a requirement to participate in the program, all youth~     had to enroll in 4-H for the 2016-2017 year. Teenagers were initially trained in~     inquiry-based and experiential learning techniques before facilitating the program. Teenage~     teachers collectively lead classroom education, garden activities, and cooking~     demonstrations. Additionally, teenage teachers, UC Cooperative Extension staff, and UC Davis~     students organized and implemented a community health fair for elementary-aged children.~      Measurements were taken on nutrition knowledge, vegetables preferences, civic responsibility,~     program fidelity, and self-efficacy for teaching nutrition. A parent interview was also~     conducted to gauge parental engagement and perception of whether their child had behavior~     changes while participating in the program. Preliminary findings from the parent interview~     show that children were more likely to support and engage in healthy eating practices~     throughout their involvement than they had before the program. Children also have expressed~     interests in continuing their participation in subsequent years. All other data for this~     intervention are currently undergoing analyses.~   "
16854|NCT03346343|"~     The purpose of this observational study is to measure pulmonary function in term and preterm~     infants with and without pulmonary disease including respiratory distress syndrome,~     bronchopulmonary dysplasia, transient tachypnea of the newborn, meconium aspiration syndrome,~     and response to treatments given to newborn infants with lung diseases using a non-invasive~     airway oscillometry system.~   "
16856|NCT03346317|"~     Asherman's syndrome is characterized by the presence of intrauterine adhesions (IUA) as well~     as symptoms such as amenorrhea, hypomenorrhea, pelvic pain, and infertility. The gold~     standard for the treatment of intrauterine adhesions is hysteroscopic intrauterine adhesions.~     The recurrence of intrauterine adhesions is a major challenge in clinical practice. It has~     been reported that dried biological aminion graft was used to prevent adhesion after the~     operation of intrauterine adhesions. Estrogen is also used for postoperative prevention of~     intrauterine adhesions. Intrauterine balloon can reduce the recurrence of adhesions after~     operation. Does the combination of balloon with amniotic products or estrogen can improve~     clinical outcomes? Therefore, this study was conducted.~   "
16857|NCT03346304|"~     PEARL is a phase III multicentre 2:1 randomised controlled trial, with an incorporated phase~     II (pilot) component. All patients consented/registered onto the trial will have an~     autofluorescence bronchoscopy (AFB) to check for the presence of high grade lesions (HGLs) in~     the lung, as verified by tissue biopsy. Only patients with one or more histologically~     confirmed lung HGL will be randomised to receive either photodynamic therapy (PDT) treatment~     with surveillance (=intervention), or surveillance alone (=control).~      The overall aim of the phase II pilot is to demonstrate a >20% response in the PDT group (at~     least 3 out of 21 PDT patients), compared to a minimum response of 5%. This will be used as~     an efficacy signal to determine whether the trial will continue into phase III. Response will~     be measured by regression of high grade lesions (HGLs) to either low grade lesions (LGLs), or~     to normal epithelium at 6 months post treatment (blind assessment). The overall aim of the~     phase III is to show that the time period over which HGLs progress to invasive lung cancer is~     significantly longer when treated with PDT compared to surveillance alone.~   "
16858|NCT03346291|"~     All participants will receive free weekly counseling (8- weeks) and free nicotine patches~     (10-weeks). They will complete assessment measures commonly used in smoking cessation~     studies. We hope to show that this treatment is feasible in this small pilot study before~     comparing it to a more established treatment in a future randomized clinical trial.~   "
16859|NCT03346278|"~     Cardiac rehabilitation (CR) is strongly recommended for patients with coronary heart disease.~     However, patient enrollment and completion of cardiac rehabilitation is low. This study will~     examine if a mobile phone intervention that uses a text messaging program can successfully~     promote participation in cardiac rehabilitation.~   "
16860|NCT03346265|"~     In the present study, the investigators propose a rehabilitative program for Parkinson'~     disease based on the combination of a neurocognitive method, i.e. visual sensory cues, with a~     neurophysiological method, i.e. RMP, in a randomized controlled trial with cross-over. The~     rationale herein was that the RMP may globally improve patients in terms of trunk control,~     motor performance, muscle tone, endurance and so on, predisposing them to improvement of the~     gait rhythm and automaticity induced by use of the visual external cues.~      The primary aim of this pilot, randomized, controlled, trial with crossover was to establish~     whether a 8-week exercise program focused at improving gait in people with PD was more~     effective than a same-duration program of standard physiotherapy. The secondary aim was to~     evaluate the effect on the disease's severity. At this aims investigators used a quantitative~     3D motion analysis system to evaluate gait parameters and UPDRS-II and UPDR-III and H-Y~     staging to evaluate the severity of the disease.~      The investigators hypothesised that the both exercise programs will improve standard~     physiotherapy, however the proposed program will yield better improvements for the people~     with PD.~   "
16861|NCT03346252|"~     This study will evaluate the effect of of botulinum toxin on the treatment of Headache~     Attributed to TMD.~   "
16862|NCT03346239|"~     The purpose of this study is to determine the clinical efficacy and neuro-cognitive~     mechanisms of Gaze-Contingent Usic Reward Therapy for social anxiety disorder, compared with~     treatment with SSRIs or waitlist control.~   "
16863|NCT03346226|"~     the hypothesis is that Dexmedetomidine seems to decrease incidence of post-operative delirium~     . one possible mechanism is that Dex have a minor influence on cognition, since it has no~     effect on GABA receptor，another is that Dex could induce a sleep similar to natural sleep,~     thereby decreasing sleep deprivation and circadian rhythm disorder in post-operative~     patients.~      In this study , investigators devise the two different sedatives(Dexmedetomidine and~     Propofol)'influence on postoperative delirium in hip fracture elderly participants under~     spinal anesthesia~   "
16864|NCT03346213|"~     Red blood cells contain a chemical called haemoglobin which carries oxygen from the lungs~     around the body. When the amount of haemoglobin is reduced, a patient is 'anaemic'. Anaemia~     can have many causes, but affects about a third of patients having major surgery in hospital.~     After their operation these anaemic patients are more likely to suffer serious complications.~     This may be because the body needs extra oxygen - and so enough haemoglobin - to heal and~     recover successfully from the trauma of surgery.~      For a similar reason, patients' overall fitness before surgery is very important. Less fit~     patients are much more likely to get complications after surgery. To help us assess the risk~     of complications, the investigators measure patients' fitness before surgery using a cycling~     exercise test. The investigators monitor a number of things that show us how well the heart,~     the lungs and the muscles respond when they are under stress. People who are very anaemic~     tend to perform less well on this cycling test.~      Anaemia is often due to a lack of iron, which helps make haemoglobin. Usually people get iron~     from foods such as red meat and spinach. Some conditions mean that patients lose iron, such~     as a tumour bleeding. Other illnesses make it difficult for the body to absorb iron from the~     gut in the first place. Both lead to a state of low iron in the body and eventually this~     leads to anaemia. One way to treat anaemia quickly before surgery is to give iron into the~     bloodstream (intra-venous). It is thought that this might reduce the risk of complications~     after surgery, but it is not known whether this is because it improves overall fitness, or~     for other reasons.~      The investigators plan to carry out a study called CAPOEIRA-I (CArdio PulmOnary Exercise~     testing and IntRAvenous Iron) to find out whether giving patients intravenous iron improves~     their fitness. The investigators will measure this by doing a cycle exercise test before and~     then at least 10 days after the iron is given. The investigators will also measure how much~     the total amount of haemoglobin chnages with iron treatment. Intravenous iron is already~     routinely used for these patients, so the only additional activity for the study is the extra~     exercise test, some extra blood tests and the measurement of haemoglobin after the iron has~     taken effect.~   "
16880|NCT03346005|"~     The present study aims to investigate the diagnostic accuracy of exhaled breath analysis with~     the Aeonose (the eNose Company, Zutphen, the Netherlands) to distinguish the breath of~     patients suspected for CRC (based on a positive fecal immunochemical test), who are truly~     diagnosed with CRC, from patients suspected for CRC in whom this diagnosis is rejected after~     colonoscopy.~   "
16920|NCT03345485|"~     Tinostamustine (EDO-S101) is a new chemical entity, an AK-DAC (a first-in-class alkylating~     deacetylase inhibiting molecule) that, in preclinical studies, has been shown to~     simultaneously improve access to the DNA strands within cancer cells, break them and block~     damage repair. This Phase 1/2 study will enroll patients with various advanced solid tumors.~   "
16865|NCT03346200|"~     This is a dose determination study aiming to identify the optimal tamoxifen dose for reducing~     the risk of breast cancer. Instead of following a very large number of women, for many years,~     treated with different doses of tamoxifen and see if they develop breast cancer, the~     investigators will include 1,440 healthy women participating in the mammographic screening~     program at two Mammography units (Unilabs mammography, Lund and Södersjukhuset Breast Centre,~     Stockholm) and measure their change in mammographic density. The change in mammographic~     density is a very good marker of therapy response. Investigators will test if 1 mg, 2.5 mg, 5~     mg and 10 mg reduce the mammographic density to the same extent as 20 mg. In summary Karisma~     2 will be a randomized, double-blinded, six-armed placebo controlled study to identify the~     dose of tamoxifen with the most favourable side effect spectra and with a density reduction~     non-inferior to 20 mg tamoxifen.~   "
16866|NCT03346187|"~     A randomized, open-label, single oral dose, 2-way crossover clinical trial to compare safety~     and pharmacokinetic characteristics of CKD-337 in healthy male volunteers~   "
16867|NCT03346174|"~     The purpose of this study is to determine whether Assisted Autogenic Drainage (AAD) or~     bouncing combined with Assisted Autogenic Drainage (BAAD), induces or aggravates acid and~     non-acid gastro-oesophageal reflux in infants under the age of one year. Infants, referred to~     the hospital for impedance-pH monitoring are included in this study.~   "
16868|NCT03346161|"~     Although clinical decision tools (CDTs) exist for a variety of treatments, CDTs designed to~     support personalized breast reconstruction decisions, particularly about type and timing of~     reconstruction, are lacking. The objective of this proposal is to develop and pilot test a~     clinical decision tool that provides personalized risk information and reflects patients'~     preferences and clinical needs.~   "
16869|NCT03346148|"~     Assessment of the knowledge levels of restaurant personnel about food allergies. A structured~     questionnaire was given through a telephonic interview to evaluate the responses of the~     respondents.~   "
16870|NCT03346135|"~     This phase II trial studies how well daratumumab after a stem cell transplant works in~     treating patients with multiple myeloma. Monoclonal antibodies, such as daratumumab, may kill~     cancer cells that are left after chemotherapy.~   "
16871|NCT03346122|"~     The purpose of this study is to evaluate safety and tolerability of JNJ-64991524 compared~     with placebo after administration of single ascending oral doses of JNJ-64991524 (Part 1) and~     multiple ascending oral doses of JNJ-64991524 (Part 2) in healthy participants.~   "
16872|NCT03346109|"~     This is an randomized, controlled, phase 3 clinical trial. The purpose of this study is to~     evaluate whether medial group retropharyngeal node （MRLN） sparing could reduce the incidence~     of radiation-caused dysphagia and improve patients' quality of life without compromising~     survival rate.~   "
16873|NCT03346096|"~     Study is designed to explore whether the introduction of Thiotepa, to the pre autologous~     stem-cell transplantation (ASCT) conditioning will reduce toxicity and thus improve outcome~     following transplantation in up to 24 patients with malignant lymphoma including both~     non-Hodgkin's lymphoma (NHL) and Hodgkin's lymphoma ( HL) improving toxicity profile ,~     reducing side effects while potentially improving the antitumor response. Specifically,we~     speculate that using the novel Thiotepa based TEAM consisted of THIOTEPA 5mg/kg on days -7-6,~     etoposide 200 mg/m2 , Cytosar (ARA-C) 200 mg/m2 on days -5,-4, -3, -2 and melphalan 140 mg/m2~     on day -1, pre transplantation conditioning regimen may allow transplantation with lower~     transplant related toxicity and thus improve outcome in this setting. Toward this aim the~     impact on toxicity profile ,engraftment and disease control will be assessed.~   "
16874|NCT03346083|"~     A Phase 1, Open-Label, Single-Dose, Non-Randomized Study to Evaluate Pharmacokinetics,~     Pharmacodynamics, and Safety of Betrixaban in Pediatric Patients~   "
16875|NCT03346070|"~     The purpose of this trial is to evaluate the safety and efficacy of Sugammadex when~     administered according to actual body weight (ABW) as compared to ideal body weight (IBW) for~     the reversal of both moderate and deep neuromuscular blockade (NMB) induced by either~     Rocuronium or Vecuronium in morbidly obese participants. The primary hypothesis of this~     investigation is that, compared to obese participants dosed based on IBW, obese participants~     receiving Sugammadex according to ABW will demonstrate a faster time to recovery to a Train~     Of Four (TOF) ratio of ≥0.9 (i.e. faster NMB reversal), pooled across NMB depth and type of~     neuromuscular blocking agent (NMBA; Rocuronium or Vecuronium) administered.~   "
16876|NCT03346057|"~     This is a randomized, active comparator-controlled, parallel-group, multi-site, double-blind~     safety trial of sugammadex (MK-8616) for the reversal of neuromuscular blockade (NMB) induced~     by rocuronium or vecuronium in adult ASA Physical Status Class 3 and 4 participants. The~     first primary objective of this study is to characterize the incidence of treatment emergent~     sinus bradycardia, treatment emergent sinus tachycardia, or other treatment emergent cardiac~     arrhythmias after administration of sugammadex. The second primary objective of this study is~     to evaluate the general safety of sugammadex in a population of ASA Class 3 and 4 subjects in~     a surgical setting.~   "
16877|NCT03346044|"~     The study compares the clinical performance of the Mosaic valve with that of the Baxter valve~     (Carpentier-Edwards) which is widely used throughout the UK and is considered to be the~     bench mark.~      Specific objectives will be to determine structural failure and valve explantation rates,~     thromboembolic events and mortality rates for each valve.~      Haemodynamic assessments will also be made using echocardiography to measure gradients across~     the valves and changes in left ventricular function and wall thickness.~   "
16878|NCT03346031|"~     Music has been used in the treatment of patient since the time Plato, Hippocrates and~     Alpharabius were alive. It is used by music therapists to help patients' social, physical,~     emotional, psychological and spiritual needs. In a study conducted, it was seen that music~     has a positive effect on pain, anxiety, depression, shortness of breath, mood, face~     expression and speech. Our aim is to evaluate the analgesic consumption of music therapy~     during egg collection applications and to compare the parameters of oxidative stress in blood~     and follicular fluid.~   "
16879|NCT03346018|"~     Today there are no tests that allow to make a precise differential diagnosis between uveitis~     from presumed tuberculous origin and uveitis by sarcoidosis. Therefore, with this study,~     investigators aim to identify, in the aqueous humor and in the blood of participants~     (patients that suffering from one of these two forms of uveitis) the presence of immunologic~     markers that distinguish between uveitis of tuberculous etiology and uveitis by sarcoidosis.~   "
16881|NCT03345992|"~     High mortality associated with sepsis and Multiple Organ Dysfunction Syndrome (MODS) calls~     for alternative, individualized therapies in selected patients that might benefit form~     specific interventions. Role of macrolides as potential immunomodulatory treatment in sepsis~     is promising, but unclear. Subgroup analysis of previous large-scale clinical trials on~     patients with ventilator-associated pneumonia or gram-negative sepsis, showed that addition~     of clarithromycin to standard antibiotic therapy conferred a significant survival benefit in~     the subgroup of patients with respiratory dysfunction and MODS. The INCLASS study is aiming~     to assess the efficacy of intravenous treatment of clarithromycin in the reduction of 28-day~     mortality among patients suffering from these entities.~   "
16882|NCT03345979|"~     This study will evaluate the efficacy of initiating treatment of schizophrenia with an~     investigational product followed by a 2-month dose of AL.~   "
16883|NCT03345966|"~     The aim of the current study is to assess the validation of Bmi-1 detection at both protein~     and molecular levels in oral epithelial dysplasia and oral squamous cell carcinoma as a~     biomarker for early cancer detection versus biopsy embedded in paraffin blocks.~   "
16884|NCT03345953|"~     This is a Group Sequential Test multicenter, randomized, double blind, placebo controlled~     phase II proof of concept trial with parallel groups to evaluate the efficacy and the safety~     of BP1.4979 15mg BID compared to placebo in RLS patients during 2 weeks double blind~     treatment.~   "
16885|NCT03345940|"~     This will be a 1:1 randomized open label trial. European and outside Europe centres will be~     involved. Aim of the project is to conduct a head-to-head comparison of effectiveness of two~     approved disease modifying treatments (DMTs) in patients with relapsing remitting multiple~     sclerosis (RRMS). The term effectiveness refers to efficacy in a real life setting: this is~     intended to be in fact the first pragmatic multi-centre randomised controlled trial to~     directly assess the effectiveness of the new oral agents approved for MS (fingolimod/FTY~     versus dimethyl-fumarate/DMF) on disease activity, disability progression, quality of life,~     functioning and symptoms. It will be a randomized trial taking place in clinical care setting~     and comparing existing therapies, any of which may constitute standard care for naive~     patients or sub optimal responders to first-line drugs. Post hoc analysis will also identify~     the better treatment strategy on the different patient subgroups. Patient overall disease~     experience will be considered for the first time as the most important outcome. In fact, in~     addition to classical no evidence of disease activity (NEDA), a new composite NEDA taking~     account also of patient point of view and quality of life, will be proposed. Finally,the~     specific effectiveness profile of the two DMTs will be addressed, by exploring comparative~     benefits on different outcomes (disease activity, disability progression, brain atrophy,~     quality of life, fatigue, psychiatric and cognitive symptoms, medication satisfaction).~   "
16886|NCT03345927|"~     To investigate the relationship betweeen plasma S-adenosylhomocysteine (SAH) levels and~     endothelial dysfunction, we plan to enroll approximately 150 patients with high risk of~     cardiovascualr disease,who will be measaured the flow-mediated dilation by B-ultrasound, and~     then measaured the plasma levels of methionine metabolites, such as SAH, SAM, and analyze the~     association.~   "
16887|NCT03345914|"~     The main objective of the trial is to demonstrate the efficacy of dupilumab administered~     concomitantly with topical corticosteroids (TCS) in participants ≥6 years to <12 years of age~     with severe atopic dermatitis (AD).~      The secondary objective is to assess the safety of dupilumab administered concomitantly with~     TCS in patients ≥6 years to <12 years of age with severe AD.~   "
16888|NCT03345901|"~     Despite improved glycemic and systemic control for many patients with diabetes, over the past~     several decades, diabetic retinopathy (DR) develops and progresses in a large proportion of~     patients, and visual loss from diabetic eye complications continues to be a leading cause of~     blindness in the US and other developed countries worldwide. Thus, even a modest ability to~     prevent DR onset or to slow DR worsening might substantially reduce the number of patients at~     risk for diabetes-related vision loss worldwide. Widespread use of an oral agent effective at~     reducing worsening of DR might also decrease the numbers of patients who undergo treatment~     for DR and diabetic macular edema (DME) and who are consequently at risk for side effects~     that adversely affect visual function. Two major studies of fenofibrate, the Fenofibrate~     Intervention and Event Lowering in Diabetes (FIELD) and The Action to Control Cardiovascular~     Risk in Diabetes (ACCORD)-eye study, have demonstrated clinically important reduction in~     progression of retinopathy in patients with diabetes assigned to fibrate compared with~     placebo. However, despite the positive clinical trial results, fenofibrate has not gained~     wide acceptance as a preventive agent by either ophthalmologists or primary diabetes care~     providers. Thus, it is important to provide further evidence demonstrating whether or not~     selectively increasing peroxisome proliferator-activated receptor alpha (PPARα) activity~     reduces progression of retinopathy in patients with diabetes and non-proliferative diabetic~     retinopathy at baseline. Pemafibrate is a more potent and selective PPARα modulator than~     fenofibrate. Its efficacy is currently being evaluated in the Pemafibrate to Reduce~     Cardiovascular OutcoMes by Reducing Triglycerides IN patiENts With diabeTes (PROMINENT) study~     for prevention of cardiovascular events in patients with type 2 diabetes. Given the large~     study cohort with a substantial proportion likely to have DR and the multi-year duration of~     the PROMINENT trial, this study represents a unique opportunity to assess effects of chronic~     PPARα activation through pemafibrate therapy on DR outcomes.~      Primary Study Objective: To assess whether treatment with pemafibrate (0.2 mg orally BID)~     compared with placebo reduces rates of diabetic retinopathy worsening in adults with type 2~     diabetes and diabetic retinopathy without neovascularization who are participating in the~     parent PROMINENT trial.~   "
16889|NCT03345888|"~     To analyze a multi-center observational study database. to select adult non-traumatic~     in-hospital cardiac arrest. Review and recored end-tidal carbon dioxide in per minute.~     Arrange them in different time line. one is in resuscitation time. The other is the time line~     which the beginning time is the time of starting appearing stable end-tidal carbon dioxide~     wave.To compare predictive power of end-tidal carbon dioxide between different time line~     during resuscitation.~   "
16909|NCT03345628|"~     There is a large and growing body of animal evidence demonstrating neuroapoptosis and~     neurodevelopmental abnormalities after exposure to anesthetic agents. This has prompted an~     FDA warning concerning use of anesthetics and sedatives in children under 3 years of age.~     There has been very little investigation of the neurodevelopment effects of prolonged~     sedation in previously healthy infants in Paediatric Intensive Care. This feasibility study~     will recruit previously healthy infants who required respiratory support with or without~     sedation at up to 6 months and assess neurodevelopmental outcomes at 6 years of age.~   "
16921|NCT03345472|"~     This is a prospective, single-arm, multi-center study evaluating the efficacy of spinal cord~     stimulation (SCS) therapy for pain relief using high dose (HD) stimulation parameters~     delivered to neural targets identified during current commercial trial stimulation~     procedures. The study will evaluate changes in back and leg pain from baseline to 3, 6, and~     12 months.~   "
18981|NCT03318484|"~     The purpose of this trial is to evaluate the safety and efficacy of sonodynamic therapy (SDT)~     in reducing atherosclerotic plaques inflammation and increasing peak walking time (PWT) among~     peripheral artery disease (PAD) patients with symptom of intermittent claudication.~   "
16890|NCT03345875|"~     Aims of the Study: To assess feasibility and acceptability of introducing HPV testing of~     self-collected vaginal specimens (self-collection for HPV) of women age 30-49 years, followed~     by visual assessment of the cervix for treatment (VAT) and treatment of women testing HPV~     positive at a district hospital, surrounding clinics and communities in Botswana.~      Background and Rationale:~      High HIV prevalence correlates with high rates of precancerous and cancerous changes on the~     cervix, and Botswana has the third highest HIV prevalence rate (22.2%) in the world. In~     Botswana, cervical cancer is the leading cause of cancer and cancer-related deaths among~     women. While the Government of Botswana has made cervical cancer a public health priority,~     and has provided cytology-based screening (Pap smears) for the past 20 years and in recent~     years began also offering VIA coupled with immediate cryotherapy for eligible precancerous~     lesions in a screen-and-treat (S&T) approach, the program still encounters multiple~     challenges. These include delays in reporting/receiving cytology results, referral~     bottlenecks for specialist care, and ultimately far fewer women being screened and treated~     than set targets. In response, in 2012 Botswana's Ministry of Health and Wellness (MoHW)~     developed a National Cervical Cancer Prevention Programme (NCCPP) Comprehensive Prevention~     and Control Strategy that includes implementing a demonstration project to gauge~     acceptability and obtain lessons that will be used in planning the roll-out of this screening~     method.~      As a result, the MoHW is exploring human papillomavirus (HPV) testing as a primary screening~     method with the future service delivery in mind through HPV testing, specifically using~     self-collected samples, as a primary screening method. HPV testing is more sensitive and~     reliable for the detection of cervical precancer and cancer than Pap testing and VIA. This~     increased sensitivity translates into two important benefits: 1) earlier detection of~     significant precancerous lesions that if treated results in a ~50% reduction in the incidence~     of cervical cancer within 4-5 years compared to Pap testing and 50% reduction in related~     deaths within 8 years compared to Pap testing and VIA and 2) lower cancer risk for many years~     for those with a negative result, which permits screening at an extended interval of 5-10~     years. The Xpert HPV test, which will be used in this study, has high sensitivity (100%) and~     relatively high specificity (81.5%) for CIN. HPV tests run on the GeneXpert® machine allow~     multiple tests (four in the model to be used in this study) to be run in an hour.~   "
16891|NCT03345862|"~     -  Objectives: To evaluate the effectiveness, in terms of reducing social isolation and~          improving the Health Related Quality of Life (HRQOL), of a non-pharmacological~          multicomponent intervention in elderly telecare users.~        -  Design: Clinical trial randomized by cluster, multicentric.~        -  Location: Nine health centers of the Andalusian Health Service (Spain).~        -  Subjects and methods: Subjects with social isolation. Age 65 or older. Residents in your~          home. Telecare users. Persons with cognitive impairment or dementia, difficulty in~          responding to scales, legal incapacitation or not giving consent will be excluded.~           9 health centers will be randomly assigned to the intervention and control groups. The~          people of both groups will be evaluated at baseline, at 4 and at 6 months. 57 subjects~          will be included in each group (n = 114).~      Variables: a) Independent: of the professional and of the patients (sociodemographic,~     healthcare, morbidity, intervention performed -multicomponent vs. non-intervention-) b)~     Dependents: social support, loneliness and HRQoL.~      The intervention includes 8 sessions at home [1 hour], every 15 days and 4 telephone [30~     minutes] -1 monthly-. To measure the effectiveness of the intervention, the Duke-UNC~     Functional Social Support Questionnaire (DUFSS), the De Jong-Gierveld Scale of loneliness,~     and the EuroQol-5D will be used to measure HRQoL.~      Univariate, bivariate and multivariate statistical analysis (multiple linear regression).~      -Aspects ethico-legal: Standards of good clinical practice and ethical principles of the~     Declaration of Helsinki. Informed consent. Application for authorization to the management of~     the Sanitary District.~   "
16892|NCT03345849|"~     The objective of this study is to evaluate the efficacy and safety of upadacitinib compared~     to placebo as induction therapy in participants with moderately and severely active Crohn's~     disease (CD).~   "
16893|NCT03345836|"~     The objective of this study is to evaluate the efficacy and safety of upadacitinib compared~     to placebo as induction therapy in subjects with moderately and severely active Crohn's~     disease (CD).~   "
16894|NCT03345823|"~     A multicenter study to evaluate the efficacy and safety of maintenance and long-term~     treatment administration of upadacitinib, an orally administered Janus kinase 1 inhibitor, in~     adult participants with Crohn's Disease.~   "
16895|NCT03345810|"~     AIO-YMO/TRK-0416 (DURATION) is a open-label, treatment stratified and randomized phase II~     study of Durvalumab, frail or elderly patients with metastatic non-squamous NSCLC with no~     targetable molecular alterations (EGFRwt; ALKtransl-) and not amenable to cisplatinum-based~     standard-combination chemotherapy but eligible for at-least mono-chemotherapy with~     gemcitabine or vinorelbine.~   "
16896|NCT03345797|"~     PK study to evaluate serum levels of testosterone post nasal delivery in two cohorts of~     hypogonadal boys.~   "
16897|NCT03345784|"~     This phase I trial studies the side effects and best dose of adavosertib when given together~     with external beam radiation therapy and cisplatin in treating patients with cervical,~     vaginal, or uterine cancer. Adavosertib may stop the growth of tumor cells by blocking some~     of the enzymes needed for cell growth. External beam radiation therapy uses high energy~     x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin,~     work in different ways to stop the growth of tumor cells, either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading. Giving adavosertib, external~     beam radiation therapy, and cisplatin may work better in treating patients with cervical,~     vaginal, or uterine cancer.~   "
16898|NCT03345771|"~     The purpose of this study is to determine whether an occlusive antimicrobial barrier dressing~     or portable negative pressure wound dressing is superior in preventing wound complications~     and infection rates in obese patients undergoing total joint arthroplasty (TJA).~     Approximately 240 subjects (120 for total knee arthroplasty and 120 for total hip~     arthroplasty) will be enrolled to evaluate the outcomes associated with silver impregnated~     dressings and negative pressure wound therapy (NPWT) in treating this subset of patients and~     analyze the cost benefit of each.~   "
16899|NCT03345758|"~     Outcomes and Long-term Quality-of-life of Patients requiring Extracorporeal Membrane~     Oxygenation are not known in china. A prospective study survey will be performed to assess~     the long-term outcome of these patients.~   "
16900|NCT03345745|"~     Hs-CRP, Fetuin-A and S100A12 are acute phase proteins associated with many systemic diseases~     and conditions. The aim of this study was to determine the clinical parameters and salivary~     Hs-CRP, Fetuin-A and S100A12 levels before and after non-surgical periodontal treatments in~     the patients with periodontal diseases.~      A total of 54 subjects were divided in to three groups; periodontally healthy (n: 18),~     gingivitis (n: 18), chronic periodontitis (n: 18). Clinical periodontal parameters, salivary~     Hs-CRP, Fetuin-A and S100A12 levels and salivary flow rates were evaluated at baseline and a~     month after the treatments. Salivary Hs-CRP, Fetuin-A and S100A12 levels were assayed by~     ELISA.~   "
25235|NCT03236688|"~     Demonstrate detection of ARv7 splice variant transcripts from exosomes in the circulation of~     MCRPC patients pre and post treatment with selective Androgen pathway inhibitors (i.e.~     abiraterone and enzalutamide)~   "
16901|NCT03345732|"~     Wound complications, such as salivary-cutaneous fistulas and skin necrosis, result in~     significant patient morbidity and death. Head and neck wounds are complicated because of~     multiple tissue layers, critical structures and variable vascularity. When vascularity is~     compromised, wounds do not heal and can lead to life threatening haemorrhage or morbid~     infections. The field of microsurgical reconstruction has developed and expanded over the~     last 20 years to specifically ameliorate these issues. The challenge is that the vascularity~     of the microsurgical transplant or the recipient tissue bed can have areas of decreased~     vascularity that cannot be appreciated by the surgeon's intraoperative exam alone. Surgeons~     would be able to make better decisions with respect to the vascularity if there was an~     imaging technique that could indicate the vascular supply of the tissues undergoing surgical~     reconstruction.~      Laser-assisted indocyanine green fluorescent dye angiography (LA-ICG) using the SPY System~     (Novadaq Technologies Inc., Richmond, British Columbia, Canada) is an intraoperative vascular~     imaging technique that improves the ability of a surgeon to assess the vascular supply in the~     surgical bed. This tool, which is approved by Health Canada for reconstructive surgery, has~     been used extensively in breast reconstruction and gastrointestinal procedures with~     encouraging results. The ability to address ischemic tissues intraoperatively could~     potentially decrease the rate of devastating wound complications in head and neck surgery~     patients. The objective of this observational study is to assess the effectiveness of LA-ICG~     in head and neck reconstructive procedures to reduce the rate of skin necrosis and fistula.~   "
16902|NCT03345719|"~     Head and neck cancer surgery presents the challenge of tumour resection in close proximity to~     critical structures such as the carotid arteries and optic nerves. The need for precise~     localization within complex 3D anatomy has motivated the development of image-guidance~     systems that account for tissue deformation and excision through the use of intraoperative~     cone-beam CT (CBCT). A prototype mobile C-arm for intraoperative flat-panel CBCT has been~     developed at UHN in collaboration with Siemens Healthcare to provide low-dose 3D images with~     sub-mm spatial resolution and soft-tissue visibility. Extensive investigation in~     pre-clinical/clinical H&N, otology, orthopaedic, lung, and spine surgery has demonstrated the~     benefit of intraoperative CBCT for improved target ablation, localization accuracy, and~     critical structure avoidance.~      Prospective clinical trial in CBCT-guided H&N surgery will be conducted to evaluate the Zeego~     robotic platform for CBCT. Patient accrual will span a wide range of surgical procedures in~     otolaryngology, including cancer resection and anatomical reconstruction in the mandible,~     maxilla, sinuses, skull base, and temporal bone. The effect of intraoperative imaging and~     surgical guidance on logistical considerations of time, workflow, and compatibility with the~     OR environment will be evaluated through the use of in-room audio/video recordings, human~     factors engineering methods, and expert feedback questionnaires obtained from the surgeons,~     nurses, and anesthetists involved in each case. This clinical investigation will help to~     further define indications for CBCT-guided H&N surgery, and serve to enable the development~     of surgical task-specific imaging protocols.~   "
16903|NCT03345706|"~     The study is designed as a pilot, open-label study to investigate the feasibility and safety~     of selective cerebral hypothermia in OHCA patients receiving ECPR.~   "
16904|NCT03345693|"~     This study focuses on the use of a specific type of at-home hand rehabilitation software,~     MoTrack Therapy, in improving the treatment of hand and wrist injuries.~   "
16905|NCT03345680|"~     This study examines the effectiveness of school dental screening in promoting dental~     attendance and reducing untreated caries among primary schoolchildren in Riyadh, Saudi~     Arabia.~   "
16906|NCT03345667|"~     Assessment of color vision in diabetic patients before and after the use of anti-vegf in the~     treatment of diabetic macular edema~   "
16907|NCT03345654|"~     This translational project aims to optimize the fitting of hearing aids by development and~     clinical validation of a toolset that guides signal processing choice based on the individual~     auditory and cognitive abilities of the patient. The clinical trial portion of the project~     will validate clinical use of the toolset by comparing a population of patients fit with the~     toolset to those fit using current standard of care. Data will be collected on patient~     outcomes, clinical impact (number of visits needed to adjust the hearing aids) and~     audiologist feedback regarding professional confidence. Clinician feedback will also be~     collected to refine implementation of the clinical application and improve its usability. It~     is hypothesized that hearing aid fittings completed using the clinical toolset will result in~     better patient outcomes, fewer post-fitting visits and a higher level of clinician confidence~     compared to standard-of-care hearing aid fittings.~   "
16908|NCT03345641|"~     Our intervention in the maternity and neonatal wards helped our sensibility to the immediate~     parental reaction to the premature birth. Among these reactions, what is called stress by~     the parents occurs most often and is at the origin of trauma. The investigators can cite the~     unexpected confrontation with a baby is far from corresponding to what the parents had~     anticipated; the stunned feeling while experiencing a chain of events rapidly taking place,~     an experience of emptiness when the baby is placed in the intensive care unit, the feeling of~     powerlessness when facing the real risk of the infant's death, the striking spectacle of~     invasive treatments, etc. The parents worry about the viability and future of their premature~     infant. Their parental impressions and more specifically those of the mother facing the~     premature birth could in and of themselves have repercussions on the development of the~     infant, by betting on a complex meeting and atypical interactions.~      These observations have driven us to elaborate on a hypothesis that finds itself separate~     from the lesion model commonly applied to premature infants, and shifts the~     psychopathological approach to the post-traumatic reaction of the mother following the~     premature birth and repositions the question of behavioral disorders of the child in the~     interaction mother-infant field. The investigators think that the premature birth can bring~     about in a second phase and notably in the mother, post-traumatic symptoms as described in~     the post-traumatic stress state, and that this reaction could have effects on the~     mother-infant interactions. The investigators have carried out the current study to clarify~     the relationship between the mother's post-traumatic reaction triggered by the premature~     birth and the mother-infant interactions.~   "
18959|NCT03318770|"~     The primary objective of the present study is to evaluate the long-term observation, in terms~     of overall survival, of adult Ph+ ALL patients treated frontline with the sequential~     administration of dasatinib and the bispecific monoclonal antibody blinatumomab according to~     GIMEMA protocol LAL2116.~   "
16910|NCT03345615|"~     After a myocardial infarction (MI), patients discharged home in sinus rhythm may develop AF~     that is asymptomatic, undetected, and undertreated. Previous studies (CARISMA and ARREST)~     have demonstrate high rates of new-onset AF recorded on implantable loop recorder (ILR),~     although the routine implantation of ILRs post-MI remains costly and invasive. The external~     loop recorder may effectively identify patients with new-onset AF through a validated~     diagnostic algorithm and targeted monitoring during a high-risk period (immediately after~     hospital discharge). We will prospectively randomize patients to receive an external loop~     recorder or standard care, evaluating rates of new-onset AF developing within 30 days after~     MI.~   "
16911|NCT03345602|"~     Head injuries are a major public health issue, with an estimated annual incidence in Europe~     of 262 per 100,000 population. Light head injury (SCI), defined by a Glasgow score between 13~     and 15, constitutes the majority (71% to 98%) of head injury cases. Despite a generally good~     prognosis, patients with TCL have a low but real risk of brain damage, whose prevalence is~     estimated at 5%. Cerebral computed tomography (CT) because of its high sensitivity for the~     detection of posttraumatic intracranial lesions (LIC), is currently considered the gold~     standard for the diagnosis of these lesions in patients considered at risk after clinical~     evaluation. The number of cTCTs performed is high with no lesion in more than 90% of cases.~     The S100B protein, a marker of brain tissue damage, is reported to reliably exclude the~     presence of brain lesions in adults as well as antiaggregants. These numerous studies show~     that its serum assay in combination with the clinical decision algorithms allows, thanks to a~     sensitivity close to 100% for brain lesions, to reduce the number of CTMc currently~     prescribed by approximately 30%, and therefore to decrease unnecessary exposure to radiation.~     Although there is no study on the subject, a gain on the duration of care in emergencies can~     be expected as well as a reduction on the cost of care by a dosage price three times less~     higher than the TDMc. Expert opinion for the use of this assay in the management of~     moderate-risk TCL at threshold ≤ 0.10 μg / L in 3h post-TC to ensure sensitivity of 100%, was~     published in 2014 in the Annales Françaises de Médecine d'Urgence.~      The use of anticoagulants has continued to increase in recent years. In 2013, it is estimated~     that 3.12 million patients received at least one anticoagulant in France. Currently, the~     international and French recommendations indicate the achievement of cTCT in anticoagulated~     TCL because it is an independent risk factor for cerebral injury and is therefore considered~     to be a high risk TCL. LIC. The hypothesis of this study is that the S100B protein assay~     could also exclude the presence of brain lesion after TCL under anticoagulation in adults~   "
16912|NCT03345589|"~     This study evaluates the effect of 18-22mg/kg/d Ursodeoxycholic in refractory Primary Biliary~     Cholangitis~   "
16913|NCT03345576|"~     Denervation following spinal cord injury (SCI) limits beneficial application of neuromuscular~     electrical stimulation (NMES). SCI with denervation results in extensive muscle atrophy that~     is accompanied with several cardio-metabolic health risks. The current proposal provides a~     novel intervention by examining the effects of long pulse width stimulation (LPWS) and~     testosterone replacement therapy (TRT) on restoring muscle size and leg lean mass after~     denervation in persons with SCI. This intervention will be rewarding for Veterans and~     Civilians with SCI who do not benefit from exercising their lower extremity muscles because~     denervation has limited the response to standard surface NMES. The investigators will study~     the biochemical mechanisms that contribute to changes in muscle size following this novel~     training. Combing both pharmaceutical and physical-therapeutic interventions will optimize~     restoration of muscle size after SCI.~   "
16914|NCT03345563|"~     Project HERO is a 12-week study of the efficacy of Body Mind Training (BMT) for reducing~     fatigue in prostate cancer survivors. This 3-arm randomized clinical trial will examine~     inflammatory biology and selected gene-expression pathways that are hypothesized to~     contribute to the intervention's effect.~   "
16915|NCT03345550|"~     This is a double-blind, randomized controlled trial comparing the effect of omega-3 fatty~     acid versus placebo on blood biomarkers of brain injury, inflammation and neurogenesis.~   "
16916|NCT03345537|"~     In eight ophthalmic units, the investigator will include all inflammatory optic neuritis (ON)~     during acute phase and rank them in two groups: 1/ ON with autoantibodies~     anti-myelin-oligodendrocyte-glycoprotein (ON MOG+) 2/ ON MOG-. The investigators will measure~     incidence of MOG-Ab in our prospective population of inflammatory ON. Then the investigator~     will compare clinical and radiological presentation of ON MOG+ versus ON MOG-.~   "
16917|NCT03345524|"~     Obstructive sleep apnea (OSA) is a prevalent condition that affects 7 to 12% of the US~     population and is characterized by repetitive collapse of the upper airway during sleep.~     Continuous positive airway pressure (CPAP) has been shown to be highly effective in the~     treatment of OSA, however, adherence is poor with up to 54% of patients being non-adherent to~     CPAP therapy by Medicare criteria, which has been attributed to inadequate patient education~     and support for CPAP therapy.~      Poor treatment adherence in patients with OSA can lead to adverse health consequences, poor~     quality of life, and patient dissatisfaction. Poor treatment adherence may be due to lack of~     sufficient patient education, time delays in delivery of care, lack of adequate healthcare~     coordination, or difficulty accessing various healthcare providers across a front desk which~     serves as a healthcare bottle-neck. Better efficiency in healthcare delivery, with greater~     connectivity through knowledgeable and trained peer volunteers and cheap cell-phones~     integrated by a smart telephone exchange may alleviate some of the care and communication~     burden faced by the healthcare system. Specifically, such community health education~     volunteers (peer-buddies) who are experienced in managing their OSA may be able to impart~     knowledge and confidence to a recently diagnosed patient in a much more personalized manner~     than that of a group therapy session.~   "
16918|NCT03345511|"~     Interventional study that evaluate analgesia and side effects of Ultrasound guided Caudal~     block preoperatively in benign canal anal surgery~   "
16919|NCT03345498|"~     Entecavir (ETV) and tenofovir (TDF) are the first-line drugs for treatment of chronic~     hepatitis B virus (HBV) infection. Chronic HBV infection gradually progress to liver~     cirrhosis. Over time, as liver damage and cirrhosis advance, the illness progress to a stage~     termed as decompensated cirrhosis, characterized by development of one or more of serious,~     life-threatening complications (ascites, hepatic encephalopathy, variceal bleeding or~     jaundice). In HBV related decompensated cirrhosis, antiviral treatment is shown to provide~     benefit.~      For HBV related decompensated cirrhosis, EVT is the drug of choice as it has been shown to be~     effective and safe. The usual dose of ETV for chronic HBV infection is 0.5 mg orally once~     daily. Somehow, the recommended dose of ETV for decompensated cirrhosis has been 1.0 mg/d.~     The literature provides no justification for using this double dose of ETV. Since 0.5 mg~     daily works well in other stages of disease, there is little reason why it should not work~     well even in treatment-naïve decompensated cirrhosis. Considering the limitations of~     available literature, physicians' are divided in their opinion about the drug dose and are~     prescribing either of the two doses of ETV for this group. Hence, there is a need to assess~     whether the usual 0.5 mg/d of ETV would work as well as the 1.0 mg/d dose of ETV in~     decompensated cirrhosis due to HBV infection.~      Investigators planned this open-labeled observational study with objective to compare the~     efficacy of HBV suppression achieved using 0.5 mg daily and 1.0 mg daily of ETV in~     HBV-related decompensated cirrhosis by comparing the mean reduction in HBV DNA level from~     baseline after 24 weeks of treatment.~      In present study investigators propose to enroll 15 participants in each group who has been~     started on either doses (0.5 mg and 1.0 mg) of entecavir and measure serum HBV DNA levels in~     blood specimens (5 ml) will be collected at different time points, i.e. at baseline, 2, 4, 8,~     12 and 24 weeks after starting entecavir.~   "
16922|NCT03345459|"~     Depression is common and debilitating disorder which, among college students, is predictive~     of significant problems including higher rates of dropout and suicidal behaviors. Despite~     viable psychotherapeutic and pharmacological options, the majority of depressed college~     students, like others in the general population, do not pursue treatment. Further, barriers~     to care, both those involving practical issues and psychological factors, lead to high~     attrition rates from treatment, resulting in modest effect sizes in effectiveness trials. In~     reaction to these alarming figures and as a means of increasing accessibility and retention,~     effective internet-based treatment for depression have been developed and tested. Despite~     increased availability, response to internet-based treatment continues to vary substantially,~     yet, controlled trials show that a meaningful proportion of patients who receive~     internet-based therapy recover. Identifying individuals with a high likelihood of responding~     to internet-based treatment would enable clinicians to target this inexpensive treatment only~     to the patients with a high probability of responding; allowing more intensive treatments to~     be reserved for patients who would not respond to internet-based therapy. The development of~     a system to make this determination would represent a major advance and address an unmet~     need.~      ICare is an online depression treatment that has been adapted for college students (e.g.,~     language used, problems discussed, embedded images). Prior work by the developers of ICare~     have tested the internet-based treatment in diverse samples of depressed adults, and prior~     meta-analytic research has demonstrated that psychological treatments for depression in~     college students are as effective relative to trials carried out among depressed adults. The~     overarching goal of the study is to: (a) test whether depressed college students utilize~     ICare, (b) identify psychosocial and clinical characteristics that increase the likelihood of~     ICare utilization, and (c) identify multivariate characteristics that predict treatment~     response.~   "
16923|NCT03345446|"~     The purpose of this American Heart Association-funded and NIH-funded study is to examine~     circulating RNAs in the acute CHF setting, how they change with decongestive therapy, and~     their function in vitro and in vivo.~      The investigators are testing the hypothesis that ex-RNA levels change significantly during~     decongestion therapy and can be used as a marker of those individuals who respond to CHF~     therapy (in terms of cardiac structure or outcome). Additionally, the translational research~     design allows the investigators to assay the effects of these RNAs on tissue phenotypes in~     vitro.~   "
16924|NCT03345433|"~     The purpose of this research is to determine if it is possible to perform group drumming as~     an intervention during HCT, to begin to understand how interactive group drumming during HCT~     treatment affects patients' well-being (good and bad) during the treatment course and in the~     first four weeks after completion of the drumming sessions.~   "
16925|NCT03345420|"~     This phase II trial studies how well hypofractionated radiation therapy works in treating~     patients with stage 0-IIB breast cancer. Hypofractionated radiation therapy delivers higher~     doses of radiation therapy over a shorter period of time and may kill more tumor cells and~     have fewer side effects.~   "
16926|NCT03345407|"~     Nemiralisib is being developed as an anti-inflammatory drug for the treatment of inflammatory~     airways disease. This study is designed to assess the dose response, efficacy, safety, and~     pharmacokinetics of nemiralisib across a range of doses [up to 750 micrograms (µg)] compared~     with placebo. The study consists of a Screening Period, a 12-Week Treatment Period and a~     12-Week Post-Treatment Follow-Up Period. Approximately 1,250 subjects with an acute moderate~     or severe exacerbation of COPD requiring standard of care (SoC) therapy will be randomized in~     this double-blind study. Subjects will be randomized to receive different doses of~     nemiralisib or placebo via ELLIPTA® inhaler. The total duration of study participation is~     approximately 6 months (170 days). ELLIPTA is the registered trademark of GlaxoSmithKline~     (GSK) group of companies.~   "
16927|NCT03345394|"~     Crack addiction has become a severe public health problem in Brazil. Crack users present~     elevated prevalence rates of psychiatric comorbidities, sexual transmitted infections and~     unemployment with high probability of living or have lived in the streets, history of~     incarceration and engagement in illegal activities. For the last 20 years a treatment called~     Contingency Management (CM) have achieved the best results regarding reduction of substance~     use, promotion of abstinence, treatment attendance and retention in treatment. The first CM~     study conducted in Brazil advocates for the efficacy of CM on all of these outcomes,~     suggesting that CM can be effective in a Brazilian population of crack users.~   "
16928|NCT03345381|"~     People staring at computer screens for long hours, blinking less frequently, or having~     long-term contact lens wear are prone to dry eye disease (DED). DED is a multifactorial~     disease accompanied by inflammation of the ocular surface. Further, DED may degrade vision~     and is associated with depression and have an adverse impact on patient's quality of life.~     Sudarshan Kriya Yoga (SKY) incorporates standardized collection of breathing techniques~     followed by Automatic Self Transcending Meditation (ASTM) may help reduce stress, depression,~     and anxiety, enhance quality of life and help decrease inflammation of the ocular surface in~     patients diagnosed with DED. SKY followed by ASTM has been shown to significantly reduce~     cortisol - cause of inflammation. Thus, the investigators will be studying the effect of SKY~     plus ASTM on inflammation markers in DED patients and will assess their quality of life. The~     investigators plan to conduct a single-center pilot RCT. Patients with DED will be randomized~     to SKY followed by ASTM plus Usual care (UC) or UC alone to assess changes in inflammation of~     the ocular surface and health-related quality of life (HRQOL). HRQOL is a vital construct~     focusing on impact of health on quality of life. Along with HRQOL the investigators will~     measure changes in extent of depression and anxiety. Additionally, majority of current~     ophthalmic literature describes changes in clinical variables whilst lacking information on~     HRQOL. Thus, there is a high necessity to assess if there is an association between HRQOL and~     routinely measured clinical data. Through this study the investigators shall attempt to~     correlate HRQOL with clinical data.~   "
16929|NCT03345368|"~     In the present study the investigators want to evaluate if the application of rTMS can reduce~     the anxiety and craving in patients with obesity helping them to follow a low carb-diet, as~     well as, to assess the changes in weight, body mass index and quality of life before and~     after rTMS or sham rTMS.~   "
16930|NCT03345355|"~     The investigators hypothesize that the T1 Dixon post-Gadolinium and T2 Dixon sequences will~     show good diagnostic performances for active sacroiliitis compared to the reference test~     (Short tau inversion recovery) and clinical-biological criteria, which will allow a better~     diagnosis of active sacroiliitis~   "
16931|NCT03345342|"~     The purpose of this study is to demonstrate that injection cycles consisting of a single~     administration of paliperidone palmitate 6-month (PP6M) (700 or 1000 milligrams equivalent~     [mg eq.]) are not less effective than 2 sequentially administered injections of paliperidone~     palmitate 3-month PP3M) (350 or 525 mg eq.) for the prevention of relapse in participants~     with schizophrenia previously stabilized on corresponding doses of paliperidone palmitate~     1-month (PP1M) (100 or 150 mg eq.) or PP3M (350 or 525 mg eq.).~   "
16932|NCT03345329|"~     More than ninety percent of adults in Taiwan are suspected to carry periodontal disease,~     which causes bad breath, swollen and bleeding gums, plaque and even tooth loss. Half of the~     patients, however, are ignorance these clinical syndromes because of no obvious pain. In this~     study, the investigators selected six periodontal disease-associated bacteria strains,~     including Porphyromonas gingivalis (Pg), Fusobacterium nucleatum (Fn), Actinobacillus~     actinomycetemcomitans (Aa), Tannerella forsythia (Tf), Treponema denticola (Td) and~     Prevotella intermedia (Pi) as diagnostic markers. Using real-time PCR and MALDI Biotyper, the~     investigators will establish the database of oral microorganisms in Taiwanese people,~     providing periodontal disease clinical markers of high-risk groups and the basis for personal~     medicine of therapy in the future.~   "
16933|NCT03345316|"~     The purpose of this study is revealing that the ratio of creatinine clearance (Ccr) to inulin~     clearance (Cin) measuring at the same time is more than 1.2.~   "
16934|NCT03345303|"~     This study evaluates the efficacy and safety of second-line treatment of bortezomib in~     advanced intrahepatic cholangiocarcinoma patients.Half of participants will receive~     bortezomib while the other half will receive best supporting care.~   "
16935|NCT03345290|"~     Cerebral glycolytic metabolism can be quantified by quantitative analysis of~     18F-Fluorodeoxyglucose (18F-FDG) Positron Emission Tomography (PET). This allows to identify~     neurological diseases at an early stage of functional abnormalities, before any anatomical~     lesions, and to differentiate them from the normal brain aging. Aging mainly leads to~     atrophy with a decrease in cerebral metabolism in the prefrontal cortex, with consequent~     deterioration of cognitive processes, in particular executive functions (5).~      In a population of 92 control subjects, investigators have already quantified the~     importance of the aging in frontal cortex hypometabolism. These patients were referred for a~     18F-FDG PET in the follow-up of lymphoma considered to be in complete remission (PET without~     cerebral step), without any chemoradiotherapy within 2 months and with normal~     neuropsychological tests (Mini Mental State Examination, MMSE, Mini International~     Neuropsychiatric Interview MINI and Frontal Assessment Batery FAB).~      However, cerebral aging can be accelerated by vascular risk factors, including increased~     central blood pressure, as investigators have recently reported in a pilot study involving~     elderly patients. This central pressure, which is directly linked to the cerebral~     micro-vascularization, can be easily measured by applanation tonometry. In this pilot study,~     investigators showed that a central pulse pressure equal or greater than 50 mmHg was~     associated with a significant frontal hypometabolism in elderly patients. This confirmed, at~     a stage of pre-clinical remodeling, the worse prognostic significance for this criterion, as~     reported in large epidemiological studies (increased risk of stroke and cardiac vascular~     events).~      However, it is not yet known whether the level of central blood pressure interfere with the~     brain metabolism of younger subjects, especially with regard to aging observed throughout~     life. If this hypothesis is confirmed, preventive therapeutic strategies for accelerated~     aging, could thus integrate the monitoring of central pressure and cerebral metabolism.~      The objective of this study is to determine, in a population of control subjects and on a~     larger scale, the impact of central blood pressure on brain metabolic aging , by using~     18F-FDG PET.~   "
16936|NCT03345277|"~     Is it possible to detect infection before it is clinically apparent? Fever is one indicator~     of infection. However, until recently, continuous temperature monitoring has not been~     feasible. With the advent of microelectronics, long battery life, and wireless transmission,~     it is now possible to continuously measure, record and report body temperature. For a period~     of 90 days, residents of a long-term care facility will have their body temperature monitored~     and then those measurements will then be compared against other available healthcare data~     such as other recorded vital signs, nursing notes, provider visits, antibiotics, and~     hospitalization records for correlation of underlying infection.~   "
16937|NCT03345264|"~     Concerns with sexual health and fertility are common among cancer patients, survivors and~     their partners. Literature reviews suggest that over 60% of survivors have reproductive~     health problems yet fewer than 20% get professional help. This study will test the uptake,~     use and effectiveness of online, interactive self-help programs for men and women with~     cancer. Participants in the study will receive up to 6 months of access to the self-help~     programs without charge. Navigation through the programs can be personalized by setting goals~     and following links to the most relevant information. The programs cover all cancer sites and~     common treatments, explaining sexual and fertility side effects. Programs also include~     step-by-step cognitive behavioral self-help exercises, guidance on available medical~     treatment options, decision aids, and video stories with actual survivors as well as~     vignettes with actors. Information for same-sex couples is included. Programs include~     suggestions on how partners can work together to cope with sexual or fertility issues.~      The primary hypothesis is that participants will report improvements in sexual function and~     satisfaction from baseline to 3-month follow-up. Secondary hypotheses will investigate~     whether more extensive use of the program is associated with better outcomes (dose-response~     effect) and whether the intervention also improves secondary outcomes such as anxiety,~     depression, relationship satisfaction, and seeking medical help. Analyses from the data will~     investigate how many people who are informed of the study decide to participate (uptake), as~     well as how often participants visit the program and which parts are used most. Both the male~     and female programs have previously been shown to help cancer survivors and partners in~     published clinical trials.~      Participants will be encouraged to invite a sexual partner to join the study, but that will~     be optional. Partners will be able to be linked for statistical analysis through their unique~     study identification numbers. Participants' use of the websites will be electronically~     tracked and compared with questionnaire outcome measures. Outcome measures include online,~     self-report questionnaires completed at baseline and 3-month follow-up. At 6-month follow-up,~     participants will complete 2 online ratings of the helpfulness of the programs. Privacy and~     security are carefully protected. The entire website meets standards for HIPAA (Health~     Insurance Portability and Accountability Act). Questionnaires are identified with study~     numbers rather than names or email addresses. Once the study data are analyzed, the list~     linking participant identifying information (names, email) and study numbers will be~     destroyed. Any publications resulting from the study will discuss group data and will not~     contain any information that could be used to identify an individual participant.~   "
16938|NCT03345251|"~     Unexplained infertility is clinically diagnosed when there are no apparent or clear factors~     causing infertility on regular infertility assessment tools . Failure of implantation is a~     possible factor causing unexplained infertility . Implantation is the main rate limiting step~     in IVF outcome. Implantation is described at cellular and molecular level by adhesion or~     fixation of good quality embryo to receptive endometrium within a critical period of time~     which is called the window of implantation .~   "
16939|NCT03345238|"~     The present study aims to evaluate the differences that may be experienced in pain and~     cervical disability, before, during and just after the intervention of the Deep Dry Needling~     in the upper trapezius muscle in active, passive myofascial trigger points (MTP) or non-MTP~     in Patients with neck pain, assessing, in turn, the neurophysiological effects on the~     Autonomic Nervous System.~      Hypothesis: Deep Dry Needling of active myofascial trigger points produces a greater decrease~     of pain and cervical disability index and increase of pressure pain threshold; Than the Deep~     Dry Needling of Myofascial Trigger Points latent or out of Myofascial Trigger Points in~     patients with chronic neck pain.~      Objective: To determine the efficacy of Deep Dry Needling applied on Active Myofascial~     Triggers (MTP) vs. latent MTP versus MTP, on pain reduction and cervical disability, in~     patients with chronic neck pain attributable to Myofascial Pain Syndrome.~   "
16940|NCT03345225|"~     The purpose of this research study is to learn about 2 types of FDA-approved catheters used~     in angiographic (X-ray of blood vessels, with radiopaque substance) procedures like DEB-TACE~     treatment. The Principal Investigator will check the beads given during the DEB-TACE. They~     will compare the way in which they are spread out in the tumor and density (how condensed~     something is).~   "
16941|NCT03345212|"~     Chronic pulmonary hypertension (PH) is associated with impaired exercise capacity, quality of~     life and right ventricular function. The disease is characterized by an increase of pulmonary~     vascular resistance and pulmonary arterial pressure, leading to right heart insufficiency.~      Despite optimized combination-medical therapy most patients remain symptomatic, have reduced~     exercise capacity, quality of life and reduced survival rates, with an annual mortality rate~     of approximately 5 -15 % or even higher.~      Previous training studies have suggested that exercise training as add-on to medical~     treatment is highly effective improving exercise capacity, quality of life and symptoms.~      The current guidelines recommend exercise training only in specialized centres including both~     PH and rehabilitation specialists who are experienced in exercise training of severely~     compromised patients.~      A specialized PH-training program has been performed in Heidelberg since 2003 including >1200~     patients with various forms of chronic PH. The exercise training program is performed in a~     special setting with an in-hospital start of the rehabilitation program. It is characterized~     by a low-dose closely supervised exercise training in small groups with additional~     psychological support and mental training.~      This training program for patients with PH will be implemented in European centers to add~     exercise training to the existing PH therapies. The effect of the training on physical~     exercise capacity will be assessed by 6-minute walking distance (6-MWD). Further clinical~     parameters will be assessed to evaluate the effect on exercise capacity, quality of life and~     symptoms.~      The aim of this study is to guide European PH-centers to become specialized centers for~     training in PH.~      126 patients will be included, who either receive exercise training or continue their daily~     sedentary life style (1:1 randomization) for 15 weeks.~      As inpatient settings are not available in all healthcare systems the training program will~     be adapted from the specific training program for PH patients developed in Heidelberg to a~     procedure, which is feasible in the local participating centres. Another objective of this~     study is to assess if the particular adopted training program specified for each~     participating centre and country is still safe and effective.~   "
16942|NCT03345199|"~     This study evaluates the effects of a 10-week inspiratory muscle training on the outcomes of~     respiratory muscle strength, fatigue, activity participation, and respiratory infection rates~     in persons with advanced Multiple Sclerosis (MS). Participants will perform daily exercise~     using the Threshold Inspiratory Muscle Trainer (IMT) device during the training period. The~     study will assess whether the participants improve after the training, and whether the~     effects can be maintained after the training ends.~   "
16943|NCT03345186|"~     This study evaluates the addition of a structured nurse led patient management programme to~     standard of care in gout patients. Half of the patient will receive the nurse led programme~     in addition to standard of care and the other half will receive standard of care only.~   "
16944|NCT03345173|"~     The incidence of opioid use disorders (OUDs) has increased to near-epidemic proportions.~     While maintenance with long-acting opioids such as methadone or buprenorphine represents an~     effective treatment strategy, it may be unacceptable to many individuals. As a result,~     long-acting injectable naltrexone (XR-NTX), an antagonist medication that blocks the effects~     of opioids for at least 4 weeks, is now indicated for relapse prevention following~     detoxification. This randomized, controlled trial aims to test the efficacy of a glutamate~     modulator at facilitating a rapid non-opioid based naltrexone induction.~   "
16945|NCT03345160|"~     This application is being submitted as a follow-up to Protocol Oral Immunotherapy for~     Induction of Tolerance in Peanut Allergic Children-The IMPACT Study. The IMPACT study was a~     double-blind, placebo-controlled study of peanut oral immunotherapy in children 12-48 months~     of age. As part this protocol, all participants who received placebo treatment were promised~     the opportunity to receive open label treatment at the conclusion of the double-blind phase~     and initial follow-up. At the time of submitting that protocol, the investigator did not~     specify any detailed protocol for the open label crossover treatment, as this is an evolving~     field, but the investigator is now ready to offer this open label treatment as promised.~   "
16946|NCT03345147|"~     The goal of this study is to assess whether 3-5 years-old children who have Vitamin A intakes~     above the tolerable upper intake level (UL=900 ug per day) have higher total body Vitamin A~     stores and biomarkers of excessive vitamin A status, compared to children with Normal Vitamin~     A intakes (250-600 ug per day).~   "
16947|NCT03345134|"~     PURPOSE: This study is being conducted to test the safety of the study drug Pembrolizumab,~     also known as MK-3475, at different dose levels in combination with the current therapy,~     (BCG), for superficial upper urinary tract transitional cell carcinoma. We want to find out~     what effects, good and/or bad, it has on upper urinary transitional cell carcinoma OBJECTIVE:~     To determine the safety of administering MK-3475 at a fixed dose of 200 mg every three weeks~     in conjunction with intrapelvic BCG treatment in high risk superficial UUTTCC patients who~     are unfit or unwilling to be treated with radical nephroureterectomy.~      STUDY DESIGN: Open-label, single center, Phase II, treatment trial TREATMENT: BCG- BCG~     treatment could be delivered both through a retrograde ureteral catheter placed under~     fluoroscopic control or through an antegrade nephrostomy tube placed by interventional~     radiology. Treatment will be once a week for 6 weeks. BCG treatment will begin on Day 1 of~     Week 7. Depending on patient's response, they may have additional treatments beyond the 6~     scheduled, but they will be outside of the patient's participation in this study.~     Pembrolizumab will be given through an intravenous needle once every 21 days (one cycle) for~     a total of 6 cycles. It will take 30 minutes for the infusion of the study drug.~     Pembrolizumab will be given on Day 1 of weeks 1, 4, 7, 10, 13, and 16 while BCG will be given~     on Day 1 of weeks 7-12.~      PROCEDURES: Following informed consent, prescreening and screening procedures will be~     performed, which will include medical history review, baseline chest x ray and EKG,~     ureteroscopy and pulmonary function tests for final eligibility status. Once subject is~     eligible, they will undergo physical exams (every 3 weeks), vital signs and weight (each~     study visit), adverse event monitoring (each study visit), ECGs (screening visit), bloodwork~     (at screening and then every 3 weeks), urinalysis at selected study visits, and concomitant~     medication review (each study visit), and questionnaires (selected study visits). After~     subject has completed week 19, they will have a study discontinuation visit, followed by a 30~     day follow up visit. The subject will then be followed at 3, 6, 9, 12, 18 and 24 months post~     treatment where vital status will be determined as well as disease recurrence status.~     Ureteroscopy will be performed as standard of care but will be considered measures for~     efficacy. Biopsy will be performed as clinically indicated.~   "
16948|NCT03345108|"~     The purpose of this study is to evaluate a methodology to determine the ability of a denture~     adhesive to restrict food ingress underneath dentures during eating.~   "
16949|NCT03345095|"~     The standard of care for newly diagnosed glioblastoma includes surgery, involved-field~     radiotherapy, and concomitant and six cycles of maintenance temozolomide chemotherapy,~     however the prognosis remains dismal. Marizomib has been tested in patients with newly~     diagnosed and recurrent glioblastoma in phase I and phase II studies. In patients with~     recurrent glioblastoma, marizomib was administered as a single agent or in combination with~     bevacizumab (NCT02330562). Based on encouraging observations, a phase I/II trial of marizomib~     in combination with TMZ/RT -->TMZ in newly diagnosed glioblastoma has been launched~     (NCT02903069) which explores safety and tolerability of this triple combination and which~     shall help to determine the dose for further clinical trials in glioblastoma. In this~     context, given that marizomib has been established as a safe addition to the standard TMZ/RT~     -->TMZ, a phase III study is considered essential to establishing its impact on overall~     survival.~   "
16950|NCT03345082|"~     A multicentre, randomised, parallel group, sham-controlled, double-masked, dose-ranging~     study, investigating two doses of OPT-302 in combination with ranibizumab compared with~     ranibizumab with sham, over six consecutive monthly dosing cycles in participants with~     neovascular (wet) AMD.~   "
16951|NCT03345069|"~     The Early Prediction Study is a longitudinal population-based cohort study for very preterm~     infants ≤32 weeks gestational age. Preterm infants recruited from three greater Cincinnati~     and two Dayton area neonatal intensive care units (NICUs) will undergo advanced MRIs at 41~     weeks postmenstrual age and neurodevelopmental testing at the corrected ages of two and three~     years correct age. The goal of the Early Prediction Study is to accurately predict motor,~     cognitive, and behavioral deficits in individual very preterm infants using neuroimaging~     technologies and established epidemiologic approaches.~   "
16952|NCT03345056|"~     To evaluate the therapeutic efficacy of sub retinal BSS injections in conjunction with~     conventional vitrectomy for refractory Diabetic macular edema (DME)- resistant to more than~     one anti-VEGF agent, intravitreal corticosteroids and to previous vitrectomy. Some of~     enrolled cases had normal vitreo-macular interface (VMI) relationship, while other cases had~     incomplete vitreoretinal separation with vitreomacular attachment (VMA).~   "
16953|NCT03345043|"~     This clinical study will assess the safety, tolerability and immunogenicity of VAL-339851 in~     healthy subjects.~   "
16954|NCT03345030|"~     Deoxyribonucleic acid (DNA) damage of granulosa cells obtained during oocyte retrieval will~     be evaluated by comet assay in unexplained infertile patients undergoing in vitro~     fertilization (IVF) treatment. The oocytes will be graded by particular criteria.~     Fertilization, embryo quality, transfer rate, implantation, clinical pregnancy, pregnancy~     outcomes (gestational age at delivery, route of delivery, and birthweight etc.) will be~     recorded as well as demographic data. DNA damage of granulosa cells will be compared between~     unexplained infertile and control groups. The effect of DNA damage of granulosa cells on~     fertilization, quality of oocyte and embryo, implantation, and clinical pregnancy will be~     also evaluated.~   "
16955|NCT03345004|"~     The objective of DIAGNODE-2 is to evaluate the efficacy of Diamyd compared to Placebo, upon~     administration directly into a lymph node in combination with an oral vitamin D/Placebo~     regimen, in terms of preserving endogenous insulin secretion as measured by C-peptide.~   "
16956|NCT03344991|"~     Infants with an estimated gestational age < 36 6/7 weeks at delivery who have been in an~     incubator in the newborn ICU for at least 24 hours will be randomized to either standard~     protocol of open crib or mylar-lined cardboard cot for the duration of the hospital stay.~     Axillary temperatures will be taken 1 hr, 6 hrs, and 24 hours after being placed in the cot~     or crib, and then once every 24 hours. All other care is provided as standard of care.~   "
16957|NCT03344978|"~     This study will determine whether the efficacy of Mylar-lined cardboard cots is equivalent to~     traditional incubators in their ability to prevent hypothermia (axillary temperature < 36° C)~     in preterm neonates <36 6/7 weeks gestational age in a randomized cross-over designed trial.~     Infants will be randomized to receive care in the cardboard cot or incubator and then cross~     over to the other device for 24 hour periods, rotating for a total of 96 hours total trial~     time.~   "
16958|NCT03344965|"~     This research study is for patients with metastatic breast cancer.~        -  Metastatic means that the cancer has spread beyond the breast. In addition, through~          genetic testing of the blood or tumor, an altered gene has been found that suggests the~          tumor may not be able to repair its genetic material (DNA) when it becomes damaged.~        -  This aspect of the cancer may cause it to be more sensitive - that is, more effectively~          killed by certain types of drugs such as the study agent being evaluated in this trial,~          Olaparib.~             -  Olaparib is a type of drug known as a PARP inhibitor. Some types of breast cancer~               and ovarian cancer share some basic features that make them sensitive to similar~               treatments. Information from those other research studies suggests that this drug~               may help to treat metastatic breast cancer.~                  -  This study will evaluate whether olaparib is effective in breast cancer~                    patients whose tumor has a mutation in one of the other genes that function~                    with BRCA1 and BRCA2 to repair damaged DNA .This mutation may have been~                    inherited from a parent, or may have developed only in the tumor.~                  -  This study will also evaluate whether olaparib is effective in breast cancer~                    patients whose tumor has a mutation in BRCA1 or BRCA2 that was acquired by the~                    tumor, but not inherited.~   "
16959|NCT03344952|"~     The aim of this retrospective, monocenter, observational study is to evaluate the changes in~     GMFCS levels of children with cerebral palsy (CP) who received repeated Botulinum Toxin-A~     (BoNT-A) injections in the lower limb(s) with an integrated treatment approach in Kocaeli~     University Department of PMR and Izmit Rehabilitation Center.~   "
16960|NCT03344939|"~     Every year 75000 new-born babies are hospitalized in neonatology yard in France with about~     60000 born prematurely.~      Studies showed that parents presence is good for the baby development , decrease the stress~     due to hospitalization.It's also efficient for the attachment between the baby and parents.~      Although the team try to settle a good atmosphere to establish this link and let parents take~     their position,it seems that the time taken to stay with the baby is less moreover the night.~      The aim of the study is to evaluate the time of presence to find tools to increase this time~     in the neonatotology yard~   "
16961|NCT03344926|"~     The aims are to test feasibility and preliminary effects of a smart phone delivered ACT~     treatment for adults with longstanding pain.~      The hypotheses are that~        1. ACTsmart will be a feasible and accessable treatment delivery form~        2. ACTsmart will improve function and quality of life~   "
16962|NCT03344913|"~     Osteoarthritis (OA) in the knee is characterized by chronic inflammatory pain that is not~     necessarily related to the amount of joint damage. Clinical practice guidelines recommend~     physical activity (PA) for osteoarthritis pain, but most adults with OA do not engage in PA.~     One reason for this is that while PA can reduce OA related joint pain, it does not work for~     everyone. PA decreases pain sensitivity for about half of adults with OA but increases pain~     sensitivity for the other half. The investigators are hypothesizing that individual~     differences in how well cells work to make energy, inflammation, and different proteins~     available in blood cells explains who PA will work to reduce pain and who it won't among~     adults with OA. The purpose of this pilot study is to determine if blood cells' ability to~     make cellular energy, inflammation and proteins help explain the difference about who PA~     reduces activity for and who it doesn't. The investigators will compare these biologic~     factors and pain sensitivity before walking, immediately after 30 minutes of walking (i.e.~     acute) and after six weeks of walking three times a week for 30 minutes (i.e. long-term)~     in adults with hip or knee osteoarthritis. The investigators will also compare these results~     to adults without OA. The investigators will recruit a sample of 40 adults with radiologic~     (e.g x-ray or CT scan) evidence of hip or knee OA and 20 age/gender matched healthy adults~     without OA to address the following study aims: Aim 1: To examine the effects of a six week~     (three days/week) walking program on pain in adults with OA as compared to healthy controls.~     Aim 2: To test the cells' ability to make energy as a mechanism for variation in pain after~     acute and long-term PA in older adults with lower extremity osteoarthritis. Aim3: To test~     the role of inflammation as a mechanism for variation in pain after acute and long-term~     physical activity in adults with lower extremity osteoarthritis. Aim 4: To generate~     hypotheses regarding the role of proteomics in variation in pain after acute and~     long-term physical activity.~   "
16963|NCT03344900|"~     National Institutes of Health (NIH)/National Heart, Lung, and Blood Institute (NHLBI)~     guidelines recommend that hydroxyurea be offered to symptomatic adults and all children with~     sickle cell disease (SCD) (HbSS and HbSβ0-thal genotypes) age ≥9 months. Research has shown~     that hydroxyurea reduces hospitalizations and mortality, supporting its effectiveness outside~     of clinical trials. Hydroxyurea is given as a once-daily oral dose that costs <$1 per day.~     Despite overwhelming evidence for positive effects, hydroxyurea is vastly underutilized.~     Given the relative ease of its administration, low cost, and safety profile, barriers to~     hydroxyurea utilization are primarily constrained to the health system and patient~     determinants. System-level barriers include insufficient access to SCD-specific care, limited~     access to medication (due to lack of health coverage), and providers' reluctance in~     prescribing it; while patient-level barriers include low acceptance (due to insufficient~     knowledge or misconceptions regarding risks and benefits), and forgetfulness leading to poor~     adherence.~      Mobile health (mHealth) refers to the practice of medicine and public health supported by~     mobile devices. Short message service (SMS) text messaging (through cell phones) is a~     widespread means of communication, particularly among adolescents and young adults and is an~     emerging intervention modality to improve medication adherence. Its low cost, simplicity, and~     prevalence allow for relatively easy adoption and dissemination in medical practices.~      This protocol seeks to examine barriers to hydroxyurea adherence among SCD patients between~     15 and 45 years of age who are living in the Memphis region by conducting a needs assessment.~     In addition to examining these barriers, the needs assessment will provide data that will~     inform the development of an mHealth application (e.g. mobile phone application) for~     assisting patients in increasing their medication adherence. The developed mHealth~     intervention will then undergo a pilot trial to test its acceptability, satisfaction, and~     feasibility among 56 patients living with SCD.~        -  To conduct multi-level needs assessment of hydroxyurea utilization barriers and~          facilitators, in Memphis, Tennessee (Phase I).~        -  To test the feasibility and acceptance of a patient-informed smart phone application~          aimed at improving hydroxyurea adherence in the Memphis, Tennessee region, and to~          estimate the efficacy parameters needed to design a definitive large phase III trial~          (Phase II).~   "
16964|NCT03344887|"~     The iTADS trial will test an important blood donor characteristic - donor sex - to see~     whether male donor blood leads to a greater benefit for transfusion recipients compared to~     female donor blood.~      The trial will help determine how the investigators can tailor the selection of blood donors~     based on donor characteristics (e.g. sex) to further improve the safety and optimize the~     clinical benefit of blood products in Canada.~   "
16965|NCT03344874|"~     The objective of this study is to compare the relative capability of Stethee® (new wireless~     digital stethoscope) and 3M™ Littmann® Classic III™ (conventional stethoscope) in the~     identification of manikin-simulated heart sounds by medical doctors. A randomised,~     non-blinded, two-period crossover, non-inferiority design will be used to compare the~     acoustic performance of the two stethoscopes. We aim to determine if Stethee® is as effective~     as 3M™ Littmann® Classic III™ for auscultation of simulated heart sounds, and whether~     Stethee® could be recommended for use in clinical practice based on a non-inferior comparison~     with 3M™ Littmann® Classic III™.~   "
16966|NCT03344861|"~     This research study is being conducted to assess the safety of PDT in subjects with~     peripherally located malignant tumors in lung parenchyma prior to surgical resection. It will~     involve up to 10 sites in USA. Participation will last 4 months.~   "
16967|NCT03344848|"~     This is an early feasibility study of a new device, the Orion Visual Cortical Prosthesis~     System. The device is intended to stimulate the surface of the visual cortex to induce visual~     perception in blind individuals.~   "
16968|NCT03344835|"~     Prostate cancer (PCa) is ranked 3rd in annual incidence of male cancer and ranked 5th for~     cancer-related death in men in Hong Kong which accounts for about 9.1 deaths per 100,000 men~     in 2011. Its incidence is rising rapidly, almost tripled in the past 10 years. In Hong Kong,~     the two main screening methods for PCa are digital rectal examination (DRE) and serum~     prostate-specific antigen (PSA) level blood test, and the gold standard of diagnosis of PCa~     is transrectal ultrasound (TRUS) with prostate biopsy.~      For those who diagnosed with PCa, there are different kinds of managements depending on~     patient's age group and disease stage. Watchful waiting is for older patients who presents~     with low-risk prostate cancer. And active surveillance is applicable to patients who are~     eligible for potentially curative management. While radiotherapy or radical prostatectomy are~     recommended as curative management for early stage PCa, androgen deprivation therapy (ADT) is~     the main treatment modality for advanced or recurrent prostate cancer. Advanced prostate~     cancer that recurrence is called castration refractory prostate cancer (CRPC). There are many~     new agents, including second line hormonal therapy, chemotherapy, androgen biosynthesis~     inhibitors, immunotherapy, bone targeting agents etc., available for the further management.~      In this study, investigators would like to establish a local prostate cancer registry to~     facilitate the collection of clinical information and outcomes of prostate cancer management.~     Hopefully, this registry can provide information regarding the epidemiology, natural history,~     and treatment outcomes of local prostate cancer. The information would be helpful for~     research, public education, health care planning and also international collaboration.~     Ultimately, patients and public would be benefited from these works.~   "
16969|NCT03344822|"~     Several studies have shown a great potential of 68Ga-PSMA PET in high risk prostate cancers~     patients and a high detection rate than 18F-Choline PET.~      The primary aim of this study is to evaluate the difference of management intent, after the~     inital staging of high risk prostate cancer patients, with 68Ga-PSMA-11 PET-CT results in~     comparison of 18F-Choline PET-CT results.~   "
16970|NCT03344809|"~     To enhance the diagnosis of unclassifiable, non-CLL B-LPDs using next-generation sequencing~     technology.~   "
16971|NCT03344796|"~     The goal is to prevent ultraviolet light (UV) overexposure by providing consumers with~     relevant, easy-to-access, specifically actionable information. This research proposal will~     develop a UV protection system consisting of an automated real-time counseling framework and~     a personal dosimeter that overcomes barriers to consumer adoption. These new, wearable~     sensors take the form of small (< 1 cm), thin (<0.1 mm), lightweight (<0.1 g), battery-free~     stickers that are fundamentally differentiated from other wearable electronics in their~     modes of use, cost structures and accuracy.~   "
16972|NCT03344783|"~     The purpose of this study is to evaluate whether early life natural exposure to fatty acid~     affects the AD risk.~   "
16984|NCT03344627|"~     Sepsis and septic shock patients are considered to have a high risk of complications and~     death. Appropriate antimicrobial therapy plays an important role in determining outcomes in~     septic patients. However, pathophysiologic changes associated with critical illness have an~     impact on pharmacokinetics of antimicrobials. In addition, increasing bacterial resistance is~     also a growing concern, especially in intensive care units., Consequently, standard~     antimicrobial dose may not be sufficient to achieve pharmacokinetic/pharmacodynamic target in~     sepsis and septic shock patients. The purpose of this study is to compare a therapy between~     meropenem standard dose and meropenem high dose in the treatment of sepsis and septic shock~   "
16973|NCT03344770|"~     This is a double-blind placebo controlled trial whose objective is to understand how much the~     radial extracorporeal shockwave therapy can improve function of patients with knee~     osteoarthritis.~      For this trial, patients with knee osteoarthritis, after signing the informed consent form~     and having their demographic and baseline information collected, will be randomly allocated~     into one of both treatment arms: radial extracorporeal shockwave therapy (rESWT) or sham~     radial extracorporeal shockwave therapy. Then, they will undertake three sessions of rESWT,~     for three weeks, i.e. one session per week.~      Patients will be assessed prior to the therapy, one week after the end of the therapy and~     three months after the end of the therapy, and the primary outcome of this study is the~     functional change measured by the Knee injury and Osteoarthritis Outcome Score (KOOS)~     validated in Portuguese, three months after the end of the therapy.~      Secondary outcomes, will be the change of pain, the change of pressure pain tolerance~     threshold, change in diffuse noxious inhibitory control (DNIC), and thermographic changes.~   "
16974|NCT03344757|"~     This 5-year study evaluates the effects of a 10-week group-based linguistically translated~     and culturally adapted cognitive-behavioral stress and self-management (C-CBSM) intervention~     on symptom burden and health related quality of life (HRQoL) in Hispanic men treated for~     localized prostate cancer (PC). About 80% PC cases are diagnosed as early disease and have a~     5- and 10-year survival rate of almost 100% and 99%, respectively. Most patients receive~     active treatment (~70%) leading to prolonged treatment-related side effects and dysfunction~     persisting well beyond primary treatment. Survival is offset by chronic side effects such as~     sexual and urinary dysfunction, pain and fatigue that can lead to poor psychosocial~     functioning, impaired intimacy and social functioning, and masculinity concerns. Hispanic PC~     survivors report lower physical and social functioning, poorer emotional well-being and~     greater sexual and urinary dysfunction, even after accounting for SES and disease severity.~     This sequela can lead to elevated glucocorticoid release and inflammatory cytokines that have~     a direct effect on these symptoms and can interfere with physiological pathways necessary for~     recovery of sexual and urinary functioning. The investigators have shown that CBSM reduces~     symptom burden and improves HRQoL in bilingual Hispanic PC survivors. In a pilot study~     conducted by the investigators, it was shown that a linguistic translation of CBSM with~     attention to sociocultural processes improved symptom burden and HRQoL in Spanish monolingual~     PC survivors. The investigators have also shown that CBSM is associated with reduced~     glucocorticoid resistance and inflammatory gene expression pathways in breast cancer~     survivors. The investigators propose to (a) deliver a culturally adapted C-CBSM intervention~     in Spanish that places greater emphasis on salient sociocultural determinants of symptom~     burden and HRQoL in Hispanics (e.g., fatalistic attitudes, family interdependence, perceived~     discrimination, machismo), (b) incorporate a neuroimmune model of symptom regulation and~     management, and (c) test the efficacy of C-CBSM, relative to standard non-culturally adapted~     CBSM, in two diverse Hispanic communities (Chicago & Miami). The investigators will test the~     aims in 260 Hispanic men post-treatment for localized PC with elevated symptom burden in a 2~     x 4 randomized design with condition (C-CSBM vs. CBSM) as the between groups factors, and~     time (baseline, 3 months post-intervention & 6- and 12-months post intervention) as the~     within groups factor.~   "
16975|NCT03344744|"~     The investigators aim to investigate and understand the circulating miRNA profiles after~     acute aneurysmal subarachnoid haemorrhage and underlying pathological significance.~   "
16976|NCT03344731|"~     The presence of damage to the central and / or peripheral nervous system resulting from~     pathologies of a different nature (such as multiple sclerosis, Parkinson's disease, dementia,~     cranial trauma, stroke, epilepsy or other neurological syndromes) is commonly a cause of~     physical and mental disability. The presence of memory or language cognitive deficits is~     often evident at a first clinical examination. However, difficulties in cognitive areas such~     as decision-making, social and emotional cognition or particular forms of learning may be~     less evident, while exerting a strong impact on the quality of life of patients.~      The main purpose of this proposal is to investigate cognitive abilities in patients with~     neurological damage, through a series of specific tasks.~      In addition, the contribution of specific brain areas to the cognitive tasks will be assessed~     by direct modulation of brain activity. This modulation will be achieved by using~     non-invasive brain stimulation techniques such as Transcranial Magnetic Stimulation (TMS) and~     Direct Transcranial Electric Stimulation (tDCS).~   "
16977|NCT03344718|"~     In 2012, a cross-sectional survey sampling 1,966 community-dwelling old people was conducted.~     Structurized questionnaires were interviewed face-to-face by well-trained staffs. An~     overnight fasting blood were obtained for biochemistry parameters.~   "
16978|NCT03344705|"~     Assessment of the Safety and Feasibility of Administering T cells Expressing an Anti-CD19~     Chimeric Antigen Receptor to Patients With CD19+ B-cell Hematological Malignancies.~   "
16979|NCT03344692|"~     Proprotein convertase subtilisin/kexin type 9 (PCSK9) has emerged over the past decade as a~     post-transcriptional regulator of the LDL receptor (LDL-R). PCSK9 acts as an endogenous~     natural inhibitor of the LDL-R pathway. Monoclonal antibodies (mAb) directed against PCSK9,~     such as Alirocumab, are the most common method of PCSK9 inhibition.~      The goal of the present study is to assess, in the context of type 2 diabetes, a situation~     associated with an increased post-prandial hyperlipemia, whether PCSK9 inhibition with~     Alirocumab affects postprandial intestinal lipoprotein metabolism.~   "
16980|NCT03344679|"~     Pectoral nerve block (PECS) has been used for post-operative pain relief in patients~     undergoing breast surgery. It has been shown that adenosine has an effect on pain modulation.~     Magnesium sulphate has been used as an adjuvant to local anaesthetics in many nerve block~     techniques. We hypothesised that adenosine may affect the PECS block quality. We aimed to~     compare the effect of adding adenosine to the local anaesthetic and compare its effect to~     magnesium sulphate when used for PECS block.~   "
16981|NCT03344666|"~     This study will use a SMART (Sequential, Multiple Assignment Randomized Trial) design to~     optimize adaptive interventions (AIs) for adolescents reporting alcohol misuse and violent~     behaviors. The study will test the efficacy of state-of-the-art adaptive intervention~     delivery approaches (text messaging, remote therapy) for reducing alcohol use and violent~     behaviors among urban teens. Given the morbidly/mortality associated with alcohol use and~     violence, this study will have significant impact by using a SMART design to identify the~     optimal intervention strategy to produce and sustain outcomes among at-risk youth.~   "
16982|NCT03344653|"~     The purpose of this study is to evaluate the clinical safety and effectiveness of the~     Resolute Onyx stent in subjects deemed at high risk for bleeding and/or medically unsuitable~     for more than 1 month DAPT treatment receiving reduced duration (1 month) of DAPT following~     stent implantation.~   "
16983|NCT03344640|"~     This is a randomized, double-blind, placebo-controlled, multi-center, Phase II study of s.c.~     secukinumab 300 mg in approximately 100 randomized patients with overuse rotator-cuff~     tendinopathy without systemic inflammatory disease~   "
16985|NCT03344614|"~     30 patients with advanced colorectal cancer will be enrolled to observe the efficacy and~     safety of raltitrexed combined with apatinib as a third-line treatment.~   "
16986|NCT03344601|"~     Huntington's disease (HD) is a genetic, degenerative neurological disease that affects~     individuals in their third-fourth decade of life and individuals can live 15-20 years with~     manifest HD. The complex disease symptoms, including motor, cognitive and behavioural~     impairments, result in loss of functional independence and progressive escalation of~     healthcare costs. The personal, social and economic consequences of HD are devastating,~     especially as there are currently no disease modification therapies available.~      Environmental factors, including exercise and physical activity, have the potential to~     minimize the functional impact of HD. Animal models of HD have provided the first evidence~     that exercise has the potential to delay or alter disease progression. A range of studies in~     clinical populations have shown that short-term exercise (< 3 months) is well tolerated and~     has the potential to improve quality of life, fitness and motor impairments in HD. Despite~     these promising studies, there are critical knowledge gaps that prevent the intelligent~     application of exercise as a therapeutic intervention in HD. Firstly, there have been no~     prospective evaluations of the potential role of physical activity and exercise in disease~     modification in HD. To date, only retrospective data has suggested that lifestyle factors,~     including sedentary behavior, could negatively affect disease progression in HD. Secondly, it~     is not known if sustained exercise (> 3 months) is feasible, and if it has the potential to~     improve cognitive outcomes, such as has been shown in other neurodegenerative diseases. Such~     longer-term studies are essential to elucidate the potential for exercise to have a~     disease-modifying effect; the mechanisms through which such improvement may occur have yet to~     be explored.~      In this trial, the investigators will employ a systematic approach for routinely collecting~     prospective physical activity and fitness data and monitoring physical activity behaviour in~     120 individuals with HD. The investigators will use a database to track physical activity and~     exercise behaviour alongside standardized disease-specific outcome measures during two annual~     visits. Assessment will incorporate VO2max, a surrogate measure of fitness and a direct~     measure of oxygen uptake related to central nervous system (CNS) function and structure, and~     the use of wearable technologies (Gene-activ activity monitors) that capture and quantify~     dose (frequency, duration, intensity) of physical activity in a large HD cohort. The~     investigators will further conduct a within-cohort randomized control trial (RCT) of a~     12-month exercise intervention in HD, comparing a supported structured aerobic exercise~     training program to activity as usual. This intervention will also incorporate a physical~     activity coaching program developed and evaluated by our group with a view to encouraging~     longer term exercise uptake.~   "
16987|NCT03344588|"~     A male factor is responsible for almost half the cases of subfertility. Varicocele is a major~     cause of impaired spermatogenesis and potentially a correctable cause. It affects up to 40%~     of men with primary subfertility and 80% of men with secondary subfertility. Varicocelectomy~     is now accepted as a cost effective treatment in subfertile men with clinically palpable~     varicocele and impaired semen parameters. Recently, Varicocelectomy is reported to improve~     fertility potential in patients with severe oligozoospermia. In one such study,~     Varicocelectomy was associated with a statistically significant increase in sperm density and~     motility. Spontaneous pregnancy was achieved in16.7% of cases. In a recent meta-analysis,~     Varicocelectomy in men with severe oligozoospermia showed a strong trend toward improvement~     in pregnancy rate (PR) [OR= 1.69, 95% CI (0.951, 3.020), p= 0.073] and statistically~     significant increase in live birth rate (LBR)[OR=1.699, 95%CI (1.020, 2.831), p= 0.04].~      The impact of ligation of internal spermatic artery (ISA) during Varicocelectomy is a matter~     of debate. Conventional view is arterial ligation can negatively affect testicular function~     and decrease the likelihood of post-operative paternity. Other investigators reported that~     ligation of ISA was not associated with significant changes in postoperative semen~     parameters, testicular size or PR in comparison to artery preservation. Moreover,~     laparoscopic artery-ligating Varicocelectomy was proved to be superior in the form of shorter~     operative time and lower recurrence rates with no difference in semen parameters or PR in~     comparison to laparoscopic artery-preservation varicocelectomy.~      Also, isolation of ISA is not an easy task during subinguinal Varicocelectomy due to~     compression by external oblique aponeurosis and its inherent anatomical variation. In 29 %~     and 57% of the cases, the ISA is surrounded by the varicose vessels and adherent to the veins~     respectively. Thus, the ISA is liable to a substantial risk of accidental ligation during~     subinguinal Varicocelectomy.~      Whether or not ligation of the ISA has a deleterious effect on the fertility outcomes in~     patients with severe oligozoospermia; this is not clear in the literature. This prospective~     randomized study was conducted to assess the impact of ISA ligation during subinguinal~     Varicocelectomy on fertility outcome in patients with severe oligozoospermia.~   "
16988|NCT03344575|"~     Laparoscopic ventral hernia repair (VHR) is usually performed by reducing the contents in the~     hernia sac from the abdominal cavity and then covering the defect from the inside with a~     mesh, i.e. Intraperitoneal Onlay Mesh (IPOM). This means that the hernia sac is left in situ~     anterior to the mesh. This may, however, predispose for the development of fluid in the~     hernia sac, i.e. seroma. The risk of seroma development may be reduced if a the defect is~     closed before the mesh is applied. Closing the defect may, however, cause tension and pain~     from the abdominal wall. Instead of closing the defect, the part of the peritoneum~     constituting the hernia sac may be used for closing the defect. In this case, the peritoneum~     is dissected from the edges of the hernia sac and then used as a flap that is fixated to the~     edges of the hernia sac on the opposite side.~      In order to evaluate whether peritoneal bridging reduces the seroma development following~     ventral hernia repair, we are undertaking a double-blind randomized controlled trial~     comparing conventional closure of the hernia defect with peritoneal bridging. The goal is to~     randomize 50 patients undergoing laparoscopic ventral hernia to conventional closure or~     closure of the defect with peritoneal bridging.~      Clinical follow-up is performed one month and one year after surgery. At both occasions, the~     patient is requested to fill in the Ventral Hernia Pain Questionnaire (VHPQ) and an~     investigation is done in order to assess the presence of seromas, recurrences or other local~     complications. One year after surgery, computer tomography is performed. The main purpose of~     the computer tomography is to quantify the presence of seromas.~      The study is intended as phase 2 study with the aim of evaluating peritoneal bridging as an~     alternative to conventional defect closure. If the study shows that bridging does not lead to~     substantial seroma development, future studies with greater statistical power and other~     outcome measures will be undertaken.~   "
16989|NCT03344562|"~     This will be a double blinded randomized clinical trial carried out at Zale-Lipshy and~     Parkland Hospital Inpatient Rehabilitation Facilities. Acute stroke patients with insomnia,~     identified by the Insomnia Severity Index (ISI), and who choose to participate in this study~     will be randomized to CES or sham CES. Patients who do not feel they are getting adequate~     sleep but want to continue in the study will be given the option to receive the standard of~     care medication as a rescue starting on the 3rd night.~      Patients will receive treatment with a Fisher-Wallace CES device or Sham CES. Treatment with~     CES will be for 20 minutes twice a day, and the treatment period will be for 7 days. Patients~     will be allowed to increase the intensity of the device from the suggested starting point of~     level 2 if they feel no improvement in sleep on night 1. Groups will be monitored with a~     wrist worn actigraph that records the patient's activity for the duration of the period of~     study and provides data on sleep latency, time spent asleep, and sleep efficiency. The~     outcome measures will be total minutes/hours of sleep, sleep efficiency and subjective~     reports of drowsiness using the Karolinska Sleepiness Scale. Actigraphic data will be~     collected 24 hours a day for 7 days. The total length of study will be 4-12 months with a~     target N of 100 consented individuals and 85 participants. Patients will be allowed to exit~     the study at any time on their own choosing. To minimize loss of subjects, patients will have~     the option to choose SOC rescue starting on the third night. Patients who choose the SOC~     rescue will continue to be monitored with an actigraph for data collection purposes.~      The investigator should discontinue study participation for a given subject or withdraw the~     subject from study if he/she believes that continuation would be detrimental to the subject's~     well-being. A subject can decide to withdraw from the study at any time and for any reason.~   "
16990|NCT03344549|"~     The modern era is characterized by progress, development and social and economic~     globalization. Currently the electronic technology has applications in a wide variety of work~     areas. A clear example of this, is telemedicine. The technological tools are increasingly~     used every day in the improvement of the processes and the attention in health, in the last~     decades, telemedicine has grown exponentially becoming more accessible to the population.~      On the other hand, and in the same way, the number of people with chronic degenerative~     diseases such as diabetes and chronic kidney disease are increasing with alarming numbers,~     The health system can not offer the attention to the great demand. The strategies used until~     now for its management have gradually evolved towards a more effective prevention and~     treatment approach which requires a multidisciplinary team. Investigate the use of new tools~     that promise to improve the service, has also become a prevailing need. Therefore, the~     purpose of this study is to know the effect of nutritional teleconsultation on renal function~     and glycemic control of patients with Diabetic Kidney Disease (DKD) in pre-dialysis stages~     (specifically G3a, G3b and G4).~   "
17150|NCT03342469|"~     The purpose of this study is to examine the effects of food additives on children with ADHD.~     This study could potentially answer an important question which still remains unanswered as~     to whether certain food additives may be able to cause behavioral changes in children with~     ADHD. In this context, food additives will be artificial food coloring.~   "
16991|NCT03344536|"~     The purpose of a phase Ib study is to find out the best or maximum tolerated dose of a~     medication or combination of medications. Therefore, the purpose of this study is to decide~     the best dose of the study drug, Debio 1347, that can be given in combination with the~     standard hormonal drug, fulvestrant. Debio 1347 and fulvestrant could shrink the cancer but~     it could also cause side effects. This study tells us about the side effects of these drugs~     when given in this new combination, and how often they occur.~   "
16992|NCT03344523|"~     This study aims to evaluate the effect of standard heart failure therapy plus oral solution~     with protein succinylate iron compared to placebo on the primary end point of 6 minute walk~     distance at 24th week in patients with chronic ejection fraction reduction heart failure and~     iron deficiency.~   "
16993|NCT03344510|"~     Patients experience discomfort from lidocaine injections. Vibrating kinetic anesthesia~     devices have been shown to reduce pain of injections in dentistry, pediatrics, and~     dermatology, though no studies of lidocaine injections in sites common to dermatologic~     surgery exist. We will conduct a randomized split-body study, in which healthy volunteers~     will rate the pain of lidocaine injections on a visual analog scale, with and without the~     vibrating kinetic anesthesia device being used during injection~   "
16994|NCT03344497|"~     The purpose of this study is to evaluate whether the addition of an animated skin surgery~     educational video to conventional in-person surgery consultation will help reduce~     pre-operative anxiety in patients awaiting outpatient skin surgery.~   "
16995|NCT03344484|"~     For the increasing numbers of patients undergoing fusion procedures for the degenerative~     lumbar spine, infection and re-operation can negatively impact outcomes. Numerous~     observational and retrospective reviews have shown advantages to para-median versus midline~     approaches; however, recent systematic reviews have shown a need for a well-powered,~     prospective randomized control trials comparing both exposures. As a step towards a long-term~     goal of an RCT to address this issue, the purpose of this pilot study is to gather initial~     data to examine whether operative approach impacts the short-term infection rate,~     re-operation rate, length of stay, and overall costs to the system. Patients deemed~     appropriate surgical candidates with single or two-level degenerative spondylolisthesis will~     be approached for participation, and randomized into either the midline or paramedian group.~     Initial follow-ups will be at 2 and 6 weeks, and 3 months. Infection rates, inpatient and~     outpatient adverse events, re-operation rates, radiation exposure and costs will be~     determined. Cost effectiveness analysis will be estimated comparing each procedure using a~     bottom-up estimation. Post-operative wound infection can have a significant effect on patient~     short and long term outcomes. If a significant difference in infection rate is demonstrated,~     as well as lower re-operation rates, shorter stays, and decreased overall costs, adoption of~     paramedian approaches to single or two-level fusions of the lumbar spine might be suggested,~     providing fuel for a full-scale RCT.~   "
16996|NCT03344471|"~     Each year in France, between 50,000 and 60,000 children are born prematurely (< 37 weeks of~     amenorrhea). Literature has shown that preterm deliveries can be associated with the~     development of PTSD (Post-Traumatic Stress Disorder) in mothers. Around ¼ of women suffer~     from a PTSD after giving birth prematurely. Moreover, studies highlighted the consequences of~     a PTSD on the child-mother relationship. Beyond the importance of early detection, it could~     be important to predict factors that make women more likely to develop a PTSD. This study~     will focus on personal factors (5 dimensions of personality). Our hypothesis is that~     personality traits are associated with the likeliness of developing a PTSD after a preterm~     delivery.~   "
16997|NCT03344458|"~     A multicenter, phase 3, long-term extension trial of TransCon hGH administered once-weekly in~     children with growth hormone deficiency (GHD) who previously participated in a phase 3~     TransCon hGH trial. Approximately 400 children (males and females) with GHD will be included.~     All study participants will receive TransCon hGH. This is a global trial that will be~     conducted in, but not limited to, the United States, Poland, Bulgaria, Ukraine, Armenia,~     Russia and Australia.~   "
16998|NCT03344445|"~     To investigate the differenec of patients' satisfaction and information gain betweem~     face-to-face interview and video introduction~   "
16999|NCT03344432|"~     Severe Trauma Brain Injury (TBIs) is a public health problem and monitoring of Intracranial~     Pressure (ICP) is a determinant key of it prognosis. Within the noninvasive methods to~     estimate the ICP, the measurement of intraocular pressure has been proposed because of its~     biological plausibility (proximity of the eye to the encephalic contend).~      Objective. Correlate intraocular pressure with ICP in children with TBIs and obtain their~     utility values.~   "
17000|NCT03344419|"~     Changes in the communication of glutamate from one brain structure to another are important~     in the development of therapy for cocaine use disorders. Our preliminary investigations~     suggest that drugs that affect glutamate exchange may be effective at promoting and~     maintaining individuals' abstinence from cocaine. The purpose of this randomized,~     double-blind, controlled trial is to test various glutamate modulators in conjunction with~     motivational enhancement therapy (MET) and mindfulness based relapse prevention (MBRP) for~     cocaine use disorders.~   "
17009|NCT03344302|"~     Cesarean delivery is defined as fetal birth through incisions in the abdominal wall and the~     uterine wall. This definition does not include removal of the fetus from the abdominal cavity~     in the case of uterine rupture or in the case of an abdominal pregnancy The guidelines of the~     Royal College of Obstetricians and Gynaecologists on caesarean section recommend a slow~     intravenous bolus dose of 5 IU of oxytocin after delivery of the infant. Intravenous oxytocin~     has a short half life (4-10 minutes); therefore the potential advantage of an oxytocin~     infusion at caesarean section is in maintaining uterine contractility throughout the surgical~     procedure and immediate postpartum period, when most primary haemorrhage occurs~   "
17010|NCT03344289|"~     The aim of the present study is to compare polyp detection rates of LCI with high-definition~     white light endoscopy (HD-WLE) in patients with Lynch syndrome in a parallel, international,~     multicenter, randomized controlled colonoscopy trial~   "
17203|NCT03341780|"~     Amblyopia is characterized by a reduction in visual acuity, contrast sensitivity, and~     binocular visual functions. The two main causes of amblyopia are anisometropia and strabismus~     which alter the synaptic connections between neurons along the visual pathway. Current~     treatment for amblyopia has indicated that the younger the amblyope, the greater the effect~     of treatment. The purpose of this study is to determine if standard amblyopia treatment~     improved visual acuity in adult amblyopes.~   "
17001|NCT03344406|"~     Asthma and chronic obstructive pulmonary disease (COPD) are chronic inflammatory conditions~     involving the small airways with airflow limitations resulting from genetic and environmental~     interactions. Currently, there are no existing subject diaries with evidence of~     responsiveness to measure the daily symptoms of asthma. Therefore, there is a need to either~     develop a new symptom diary to characterize subject burden of asthma symptoms or modify/adapt~     an existing tool from a related disease area for use in subjects with moderate to severe~     asthma. The E-RS in COPD (E-RS: COPD®) questionnaire was developed as a measure of daily~     respiratory symptoms associated with COPD. The fixed dose combination of fluticasone furoate/~     umeclidinium/ vilanterol (FF/UMEC/VI) administered via the ELLIPTA® dry powder inhaler (DPI)~     has been developed for the treatment of asthma. This cross-sectional, qualitative study is~     designed to understand the symptoms and disease experience of subjects with moderate to~     severe asthma. This study will also evaluate underlying concepts that are most important to~     asthmatic subjects compared to symptoms and concepts included in the E-RS: COPD and two~     supplemental asthma items (wheeze and shortness of breath with physical activity).~     Approximately 32 subjects will be included in the study and interviewed via telephone. Each~     interview including time for consent, qualitative interview, and completion of case report~     forms (CRFs) is expected to last approximately 60 to 90 minutes. Subjects will be expected to~     complete a daily diary for the next 7 days, following the initial telephone interview. E-RS:~     COPD and ELLIPTA are registered trademarks of GlaxoSmithKline group of companies.~   "
17002|NCT03344393|"~     .The aim of this study is to identify the analgesic effect of intraoperative ketamine~     intravenous infusion on patients undergoing intestinal surgery and its effect on salivary~     cortisol and alpha amylase levels as indicator of its effect.~   "
17003|NCT03344380|"~     Some of the liver transplantation recipients experience postoperative acute kidney injury due~     to various causes including genetic factors. Prevention of postoperative acute kidney injury~     is essential for postoperative care in liver transplantation recipients. The aim of this~     study is to investigate the relationship between gene polymorphisms and the occurrence of~     acute kidney injury after liver transplantation by performing genome-wide association study~     (GWAS).~   "
17004|NCT03344367|"~     This is a single arm, open-label, dose escalation clinical study to evaluate the safety and~     efficacy of infusion of autologous CD19-targeted chimeric antigen receptor (CD19 CAR) T cells~     in adult subjects with relapsed and refractory B-cell Non-Hodgkin lymphoma.~   "
17005|NCT03344354|"~     A prospective open-label study design was chosen because it will provide the most accurate~     data on the efficacy of four commercially available similar brands of NRL (natural rubber~     latex) and synthetic latex surgical gloves when they are used for surgeries in a clinical~     setting. The primary endpoint will be the overall failure rate of the Biogel® sterile~     surgical undergloves (device) compared to undergloves from Ansell, Medline, and Cardinal~     brands of surgical gloves. The secondary endpoints are perforation rates of the underglove,~     the failure rate of the overglove, the frequency of overglove perforation detection by the~     glove wearer when double-gloving, the ratio of perforations detected of overglove compared to~     underglove and to determine the frequency of overglove perforation detection by the glove~     wearer.~      The clinical investigation will be statistically powered to test the hypothesis that the~     failure rate of the Biogel® Sterile Surgical undergloves is different from that of the three~     comparators.~   "
17006|NCT03344341|"~     This is a 24-week, multicenter, randomized, open-label, parallel-group, active controlled~     Phase IV study to assess the efficacy and safety of Dapagliflozin as monotherapy compared~     with Acarbose in patients with T2DM who were inadequately controlled with diet and exercise.~      The study is designed to evaluate the efficacy and safety of dapagliflozin monotherapy~     compared with acarbose monotherapy in patients with T2DM inadequately controlled with diet~     and exercise.~   "
17007|NCT03344328|"~     Cancer-induced peripheral neuropathies (CIPN) remain a real problem in oncology (Balayssac et~     al., 2011). These CIPN are induced by certain classes of anticancer drugs such as taxanes~     (paclitaxel and docetaxel), platinum salts (cisplatin and oxaliplatin), alkaloids of~     Madagascar periwinkle (vincristine), bortezomib, thalidomide and eribulin (Balayssac et al.,~     2011; Vahdat et al., 2013). These CIPN essentially translate into sensory disorders such as~     paresthesia, dysesthetics or numbness. More rarely, these CIPN may be associated with motor~     or vegetative disorders (Balayssac et al., 2011). According to the recent meta-analysis by~     Hershman et al., no treatment can be proposed as a gold standard for preventing or treating~     CIPN (Hershman et al., 2014). As a result, oncologists reduce or stop doses of neurotoxic~     anticancer drugs because patients with CIPN have a marked deterioration in quality of life~     and co-morbidities such as anxiety, depression and sleep disorders (Hong et al., 2014; Mols~     et al., 2014). Therefore, understanding the pathophysiology of CIPN is essential to propose~     new therapeutic strategies.~      Among neurotoxic anticancer drugs, bortezomib remains relatively little studied in terms of~     pathophysiology compared to platinum salts or taxanes, while the neurotoxicity of bortezomib~     remains a limiting factor in treatment. Since 2012, the FDA and EMA have validated the~     administration of bortezomib subcutaneously instead of intravenously in order to limit the~     neurotoxicity of bortezomib (Minarik et al., 2015). Indeed, a large study (N=222) reported~     that subcutaneous administration of bortezomib allowed the same therapeutic efficacy to be~     maintained while improving the safety profile and in particular limiting peripheral~     neuropathies (CIPN all grades: 38% vs. 53%, p=0.044, grade> 2: 24% vs. 41%, p=0.012 and~     grade> 3: 6% vs. 16%, p=0.026) However, a recent retrospective study (N=446) reports that the~     prevalence of bortezomib-induced peripheral neuropathies after subcutaneous administration~     remains relatively high: all grade: 41%, grade> 2: 18%, grade> 3: 4%, and above all that this~     prevalence is not different between subcutaneous and intravenous routes (Minarik et al.,~     2015).~   "
17008|NCT03344315|"~     The purpose of this multi-center study is to compare the effectiveness of Mucograft versus~     connective tissue graft in combination with coronal advanced flap for the treatment of Miller~     class III recessions The connective tissue graft in combination with coronal advanced flap is~     considered the gold standard for the treatment of gingival recession in terms of percentage~     of root coverage and complete root coverage. However connective tissue graft harvesting from~     the palatal mucosa is often associated with increased patient morbidity, prolonged surgical~     time and is limited supply. To overcome these inconvenients many efforts are made to develop~     new materials (healing modifiers, barrier membranes and grafts substitutes) Recently a new~     two-layer , xenogenic collagen matrix (Mucograft: Geistlich Pharma , Wolhusen Switzerland)~     has been proposed for regenerative therapy involving teeth and implants. The use of this~     porcine collagen matrix has obtained promising results for treatment of Miller class I and II~     recession defects (isolated and multiple recession defects) The mayority of root coverage~     studies in the literature treats Miller class I and II recession defects .Surgical treatment~     of class III recesión defects is more challenging due to loss of interproximal bone and soft~     tissues and complete root coverage may not be expected . But some recent studies demonstrate~     complete root coverage and high percentage of root coverage in class III recessions. Also a~     new classification system using the level of interproximal attachment level has been proposed~     to predict the final root coverage outcome.~      So ,the soft tissue substitutes should be used also in Miller class III recession, and~     because of that fact, the investigators are conducting this study, to evaluate the~     effectiveness of Mucograft in Miller class III recessions compared with connective tissue~     graft.~   "
17056|NCT03343691|"~     Blood samples from a total of 200 women in two cohorts will be collected and analyzed by~     TM-B1 assay, which is based on TBIA (Total Biochemical Infrared Analysis) to confirm the~     presence of cancer. These two cohorts will yield 75 healthy women with no pathological~     findings, 75 women diagnosed as having benign breast tumor and 50 women diagnosed as having~     breast cancer.~   "
17011|NCT03344276|"~     Decreased blood flow to the brain can cause decreased cognitive function. Carotid disease can~     result in decreased blood flow to the brain. The investigators seek to assess this~     relationship prospectively through performing a battery of neurocognitive assessments,~     collection of serum markers of inflammation, and through neuroimaging at two points before~     intervention (2 months and 1 month before stenting) and at two points after intervention (1~     month and 2 months after intervention). The goal is to provide prospective evidence to~     identify the extent to which carotid stenosis and hypoperfusion of the brain results in~     diminished neurocognitive performance, and see if serum biomarkers before and after stenting~     correlate with these findings.~   "
17012|NCT03344263|"~     It is a monocentric prospective pilot study in Poitiers University Hospital, specifically~     analyzing the vigilance disorders in the Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)~     and their reversibility after 6 months of Continuous positive airways pressure (CPAP).~      All subjects were administered a test of vigilance (Test of Attentional Performance) both~     before and after the 6 months of CPAP.~      The main objective is the study of the reversibility of alertness disorders on the number of~     omissions in the subtest visual vigilance of the TAP ( (Test of Attentional Performance) at 6~     months of CPAP in the OSAHS in patients with a memory complaint.~   "
17013|NCT03344250|"~     This is a phase I trial using EGFR Bi-armed Activated T-cells (BATs) in combination with~     standard of care temozolomide (TMZ) and radiation (RT) in patients with glioblastoma (GBM).~     The purpose of the study is to determine a safe dose of EGFR BATs when given with standard of~     care therapy and will require a minimum of 3 and a maximum of 18 patients to identify this~     dose.~   "
17014|NCT03344237|"~     The purpose of the Heidelberg Registry of Atrial Fibrillation (HERA-FIB) is to collect data~     on the prevalence and clinical significance of elevated cardiac troponin in a large registry~     of unselected patients with atrial fibrillation presenting to an emergency department in the~     era of novel oral anticoagulants (NOACs).~   "
17015|NCT03344224|"~     Whether the pre-operative blood lipid level and post-operative cardiovascular events is~     associated is unknown. This study is to find out the main blood lipid and relative protein~     level change and the post-operative cardiovascular events occurrence.~   "
17016|NCT03344211|"~     This randomized phase II trial studies how well enzalutamide with or without radium Ra 223~     dichloride in treating patients with castration-resistant prostate cancer that has spread to~     other places in the body. Enzalutamide is an androgen receptor inhibitor that may slow down~     the growth of prostate cancer by blocking the action of the male hormone testosterone and~     other male hormones called androgens. Radiation therapy uses high energy alpha particles to~     kill tumor cells and shrink tumors. Enzalutamide with or without radium Ra 223 dichloride may~     work better in treating patients with castration-resistant prostate cancer.~   "
17017|NCT03344198|"~     The study will explore the capacity for a lifestyle modification in volunteer firefighters to~     improve blood pressure, blood vessel stiffness, inflammation, and reduce oxidative stress.~     The study will be a randomized controlled trial with three groups. The interventions will be~     a weekly circuit workout program including yoga practice, a Mediterranean diet, or a~     combination.~   "
17018|NCT03344185|"~     This study provided 24 healthy subjects with two diets that varied in their glycaemic index~     values. One condition was a low GI diet, whilst the other was a high GI diet. Glucose~     concentrations and mood were measured throughout each test day.~   "
17019|NCT03344172|"~     This is a randomized phase II trial that will examine the ability of Avelumab to improve the~     clinical activity of a pre-operative regimen of gemcitabine, nab-paclitaxel and~     hydroxychloroquine in subjects with potentially resectable adenocarcinoma of the pancreas.~   "
17020|NCT03344159|"~     The purpose of this study is to evaluate the safety, tolerability and mechanistic effects of~     spironolactone, an aldosterone receptor antagonist, on sympathetic nervous system activity~     and right heart function and remodeling in patients with chronic right heart failure.~   "
17021|NCT03344146|"~     Primary objective of the MAAESTRO trial is to evaluate the impact of an educational and~     reminder-based intervention on the adherence of stroke patients to DOACs. Secondary~     objectives are to evaluate the association between non-adherence and clinical events, to~     identify predictors of non-adherence and to compare objective measures of adherence with~     self-reporting.~      Key methodological instrument for this study will be the Time4Med pillbox with Smart/~     Reminder Card. The study includes 3 visits (baseline visit 0, follow-up visit 1 and~     end-of-study visit 2) with a total follow-up of 12 months.~      After an initial 6-month observational phase with electronic monitoring of adherence using~     the Smart Card, all patients will receive counselling based on their electronically~     recorded drug intake data, as well as a multicompartment pillbox. Patients will be then~     randomised to one of two groups in a crossover design, so that in the subsequent 6-month~     interventional phase one group will use a (reminder-delivering) Reminder Card for the first~     3 months and the Smart Card for the last 3 months, while the second group will use the~     cards in reverse order.~   "
17022|NCT03344133|"~     Evidence suggests that gut microbiota contributes to the development of atherosclerosis and~     therefore CVDs. Exercise has been extensively reported to be protective against CVDs due to~     modification of body fatness, metabolic risk factors and cardio-respiratory fitness. It~     remains unclear whether impact of exercise on CVD risk can be at least in part explained by~     changes in the microbiota. It also remains to be investigated whether modification of~     appetite and appetite hormones due to participation in exercise are related to changes in the~     gut microbiota composition. Therefore, this study will be conducted in overweight, healthy,~     sedentary women and will investigate the effect of a 4-week moderate intensity exercise~     programme on gut microbiota composition and metabolic activity, plasma concentrations of~     fasting and postprandial lipids, glucose, insulin and inflammatory markers, fasting and~     postprandial gut appetite hormones, subjective appetite measures and cardio-respiratory~     fitness.~   "
17057|NCT03343678|"~     The main objective of this trial is to determine the maximum tolerated dose (MTD) of BI~     836826 in combination with venetoclax on the basis of dose limiting toxicities (DLTs~     incidence rate during the MTD evaluation period of the combination treatment and to determine~     the recommended Phase II dose (RP2D) of the combination.~      Other objectives are to evaluate the pharmacokinetics of BI 836826 in combination with~     venetoclax and to further determine the safety, as well as to evaluate the efficacy of the~     combination by means of the Complete Response (CR) rate and Minimal Residual Disease (MRD)~     negativity rate.~   "
17023|NCT03344120|"~     JJ ureteral stents are often positioned at the end of a ureteroscopy and often cause~     important comorbidities. Indeed, up to 80% of the patients complain a deterioration of the~     quality of life. In order to reducing the symptoms to the minimum, the producing companies~     developed different types of stents, hypothetically thinking that modifications in materials~     and designs might reduce patients' discomfort.~      Classic ureteral stents have a proximal J and a distal J as anchors respectively in the~     kidney and in the bladder. Talking about materials, most ureteral stents are made up of~     polymers, especially polyurethane and its derivatives, and silicon. Next to these ones,~     producing companies have also designed metallic or mixed stents in order to reducing radial~     resistance.~      In literature there are not many studies that adequately make a comparison of the symptoms~     related to the different types of stents. In particular, there are not many comparing~     symptoms caused by traditional hydrophilic Vortek JJ and symptoms caused by silicone JJ.~      From 2008 an Italian version of USSQ is at disposal in order to evaluating with a standard~     method the symptoms reported by patients after ureteral stent positioning.~      Aim of this study study is comparing prospectively in a randomized way symptoms of patients~     with traditional hydrophilic Vortek JJ and symptoms of patients with silicone JJ by~     submitting USSQ to the patients who undergo a URS with laser lithotripsy for ureteral~     lithiasis.~   "
17024|NCT03344107|"~     JJ ureteral stents are often positioned at the end of a ureteroscopy and often cause~     important comorbidities. Indeed, up to 80% of the patients complain a deterioration of the~     quality of life. In order to reducing the symptoms to the minimum, the producing companies~     developed different types of stents, hypothetically thinking that modifications in materials~     and designs might reduce patients' discomfort.~      Talking about materials, most ureteral stents are made up of polymers, especially~     polyurethane and its derivatives. Classic ureteral stents have a proximal J and a distal J as~     anchors respectively in the kidney and in the bladder. Different types of ureteral stents~     have been proposed along the years in order to improving the efficacy and reducing the~     complications. As long as the bladder J has been identified as one of the determining factors~     of the low tolerance to stents, other shapes and designs were proposed along the years to~     reduce the impact of the distal end. In particular, one type of stent was designed by~     substituting the distal J with a double loop in order to reducing the bladder impact.~      Literature related to efficacy of bladder double loop in reducing symptoms caused by stent~     positioning and in improving comfort in comparison with a traditional hydrophilic Vortek JJ~     are extremely limited.~      From 2008 an Italian version of USSQ is at disposal in order to evaluating with a standard~     method the symptoms reported by patients after ureteral stent positioning.~      Aim of this study study is comparing prospectively in a randomized way symptoms of patients~     with bladder double loop stent and symptoms of patients with traditional hydrophilic Vortek~     JJ by submitting USSQ to the patients who undergo a RIRS with ureteral sheath and laser~     lithotripsy for renal lithiasis.~   "
17025|NCT03344094|"~     Ocrelizumab is FDA approved for therapy of multiple sclerosis (MS). It depletes B cells and~     stops MS inflammation.~   "
17026|NCT03344081|"~     Meditation skills, or paying attention to internal mental states, are thought to improve~     people's health. This study is developing a new brain measure of meditation skills, called~     the EMBODY Task, using functional magnetic resonance imaging (fMRI). The investigators are~     testing whether pattern recognition methods can be applied to fMRI data to identify mental~     states during meditation, including attention to the body and to thoughts. This task is being~     developed in meditation practitioners and non-meditators. The goal is to understand what~     people are paying attention to during meditation using brain data. The investigators~     hypothesize that pattern recognition technology will be able to identify different mental~     states that occur during meditation.~   "
17027|NCT03344068|"~     Radiation therapy remains the principal treatment for nasopharyngeal carcinoma (NPC). The~     most frequently occurred radiation-related side effect is probably the radiation-induced oral~     mucositis, which affects up to 100% of NPC patients receiving radiation therapy, especially~     combined with chemotherapy. Significant weight loss caused by Oral mucositis will keep~     patients in worse nutrition status and then to decline immune function, hematopoietic~     function and repair function, which will influence the patient's quality of life, reduce the~     tolerance of treatment, and affect treatment effect. At present, the guidelines at home and~     abroad more and more emphasize that early nutrition treatment and intervention before~     systemic malnutrition, also suggest nutrition treatment and intervention at the same time of~     anti-tumor treatment. First choice of nutritional intervention is oral nutrition supplement.~     Nutren® Optimum has a higher protein ratio and 50% of the protein sources were lactalbumin~     and 50% casein. Lactalbumin is a high-quality protein, with the highest nutritional value~     among a variety of proteins. A cup of 210ml's Nutren® Optimum contains 5g lactalbumin.~     Nutren® Optimum also contains dietary fiber, vitamin E, monounsaturated fat, L-carnitine, 30~     kinds of vitamins and minerals and other nutrients, which can provide a comprehensive and~     balanced nutrition. This single center, open-label, randomized controlled clinical trial~     selects Nutren® Optimum as oral nutritional support for interventional group while routine~     diet guidance for control group, aiming to evaluate the efficacy and safety of early and~     whole course nutritional support by Nutren® Optimum during intensity modulated radiation~     therapy for nasopharyngeal carcinoma which can improve patients' nutritional state and~     quality of life, reduce side effects and improve the tolerability and effectiveness of~     antitumor treatment.~   "
17028|NCT03344055|"~     This is a prospective study comparing endocuff-assisted colonoscopy to standard colonoscopy.~     The goal of this study is to evaluate the interest of second-generation Endocuff Vision (ECV)~     to improve Adenoma detection rate and / or Polyp detection rate as the Mean Number of Polyps~     (average number of polyps) in routine colonoscopy.~      This is a prospective comparative study, on 2000 patients, 1000 in each group (with and~     without ECV)~   "
17029|NCT03344042|"~     Epidural anesthesia is used to relieve labour pain which helps reduce labour stress, increase~     comfort and improve cooperation with medical personnel. Administering opioid into the~     epidural space before cervical dilation of 4cm in the primigravida or 3cm in the multiparous~     can effectively reduce the pain levels with no effect on the labour progress. The aim of the~     study is to compare different opioids administered in this early labour stage.~   "
17030|NCT03344029|"~     This was a blind-observer, monocenter, randomized, comparative, Phase IV study designed to~     evaluate the immunogenicity and safety of the Sanofi Pasteur Shenzhen Trivalent Influenza~     Vaccine (SP Shz TIV) versus the Trivalent Influenza Vaccine manufactured by Hualan Biological~     Engineering Inc (Hualan TIV) comparator in healthy Chinese participants aged 18 to 59 years.~   "
17058|NCT03343665|"~     A phase I/II trial to evaluate the safety and efficacy of nivolumab at the fixed dose 40 mg~     in patients with relapsed or refractory Hodgkins lymphoma.~   "
17059|NCT03343652|"~     A clinical study of safety and efficacy of treatment with Nivolumab and Bendamustine (NB) in~     patients with relapsed/refractory Hodgkin's lymphoma.~   "
17031|NCT03344016|"~     Target population:~      Patients with (1) newly diagnosed or (2) past history of pheochromocytomas and paragangliomas~     (PPGL) or (3) carrier of genetic mutations in known PPGL susceptibility genes.~      International multicenter prospective cohort study with randomized intervention (special care~     follow-up vs. standard care follow-up).~      All patients will receive instructions about follow-up at the time point of study inclusion.~     Patients randomized to the standard care follow-up group will be advised to return annually~     for follow-up according to current routine practice (without active re-scheduling). In~     contrast, patients randomized to the special care follow-up group will also be advised to~     return annually for follow-up but these patients will be actively invited, re-scheduled and~     reminded by the centers to meet scheduled follow-up appointments.~   "
17032|NCT03344003|"~     Uncontrolled, multi-centre, non-interventional study with a prospective and a retrospective~     cohort, to evaluate the efficacy of Wilate in achieving complete or partial immune tolerance~     induction (ITI) success in severe and moderate haemophilia A patients with inhibitors~   "
17033|NCT03343990|"~     Comparison between interlocking multi-twisted wires and Eight figure of sternum closure post~     open heart surgery in egptian patients~   "
17034|NCT03343977|"~     This study is designed to investigate the toxicity and pharmacokinetics (PK) of 2-weekly and~     3-weekly docetaxel in metastatic hormone-sensitive prostate cancer (mHSPC). Also, a~     mechanism-based population pharmacokinetics/pharmacodynamics (PK/PD) model will be developed~     to provide a better understanding of the complex relationships between the drug exposure and~     toxicity profiles of docetaxel in mHSPC.~   "
17035|NCT03343964|"~     The goal of this study is to determine whether the addition of aEEG to cEEG in clinical~     practice does in fact help PICU physicians detect subclinical seizures in this population.~   "
17036|NCT03343951|"~     This study investigates the agreement between extended scope physiotherapists (ESP) and~     orthopaedic surgeons (OS) on diagnosis and treatment plan in an orthopaedic outpatient~     shoulder clinic. Furthermore a cost analysis and an evaluation of the interdisciplinary~     collaboration at the orthopaedic outpatient shoulder clinic (termed shoulder clinic in the~     following) will be performed.~   "
17037|NCT03343938|"~     There is not yet a standardized system of human embryonic culture in vitro. In addition,~     technical improvements continually appear. The investigators recently carried out a study in~     which it shows that the grouped embryo culture at low oxygen tension (5% O2) in a benchtop~     incubator shows better success rates than individual culture at atmospheric oxygen tension~     (20% O2) in a conventional incubator. For these reasons, the investigators have decided to~     continue this research line to evaluate the efficacy of a new ART station with a closed~     environment in comparison of an open flow cabinet. This new system keeps a controled~     environment maintaining a carbon dioxide (CO2) concentration of 6% and a temperature of 37~     degrees. A prospective randomized study will be carried out in which the manipulation of the~     gametes and pre-embryos of the patients will be carried out in open laminar flow cabinets or~     in a closed station that maintain the CO2 and temperature conditions.~   "
17038|NCT03343925|"~     SHARP-C is an observational cohort study investigating the effect of direct-acting antiviral~     (DAA) therapy and reinfection in people with chronic hepatitis C virus (HCV) and recent~     injecting drug use. A prospective, observational cohort design will be used to enrol patients~     attending tertiary drug and alcohol and primary health care services.~      Participants will be prescribed a direct-acting HCV medication as per the standard of care.~     The on treatment phase will vary dependent on the type of a direct-acting antiviral~     prescribed as per the standard of care. Once patients have completed their treatment course~     they will be followed up every 3 months for up to 3 years following the end of treatment~     phase.~      The study will aim to evaluate the incidence of HCV reinfection following successful DAA~     treatment over the three years of follow up. The study will also evaluate the proportion of~     patients with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) with~     direct-acting anti-viral HCV therapy.~   "
17039|NCT03343912|"~     This clinical trial is performed as proof of pharmacological action investigation by~     demonstration of ovulation inhibition (dose-response study) under treatment with three Test~     vaginal rings releasing varying doses of estriol (E3) and trimegestone (TMG).~      Blood samples for determination of estradiol (E2) and progesterone (PG) levels will serve as~     pharmacodynamic surrogate parameters for characterization of the treatment effect on the~     endogenous hormones.~      Blood samples for determination of E3 and TMG in plasma will be collected in order to~     characterize pharmacokinetic parameters.~      Additionally, local tolerability characterized by gynecological inspection of the vaginal~     mucosa prior to and after insertion of the Investigational Medicinal Product (IMPs) is~     planned to be assessed~   "
17040|NCT03343899|"~     The objective of our study will be to analyze the interplay between particular VDR variants~     and its ligand in cells obtained from intervertebral disc and cartilage endplate and their~     action on cell proliferation and phenotype maintenance. The identification of novel molecular~     targets in the vitamin D pathway, potentially promoting pathological alterations of the~     tissues involved in spinal disc diseases, will allow to develop innovative and more~     personalized preventive and pharmacological/nutritional therapies.~   "
17041|NCT03343886|"~     Age with Health is a longitudinal cohort study aimed to examine trajectories of health,~     disability and wellbeing and their determinants for Spanish ageing population. Two waves have~     carried out so far. Wave 1 (2011-2012) and Wave 2 (2014-2015). Wave 3 will be conducted 2018,~     including also a new cohort of participants (Called 2018 Cohort). The study will provide~     reliable measures of population ageing and adult health in Spain - and will provide the basis~     for cross-country comparisons with longitudinal studies conducted in other countries.~   "
17042|NCT03343873|"~     This research is a prospective double-blinded randomized controlled study. It will mainly~     discuss the mild sedative mechanism and the effect on brain functional connectivity and~     simultaneous EEG of midazolam, dexmedetomidine, propofol and ketamine.~   "
17060|NCT03343639|"~     Study of the efficacy, safety, and tolerability of serlopitant for the treatment of pruritus~     in adults with plaque psoriasis~   "
17205|NCT03341754|"~     This is a study designed to assess the safety, tolerability, immunogenicity, and protective~     efficacy of 2 heterologous prime-boost vaccine regimens in healthy, malaria naïve adults. The~     study will include 2 vaccine groups and an infectivity control (IC) group consisting of~     non-immunized subjects. Subjects to be immunized will be randomly assigned to one of two~     vaccine groups.~   "
17043|NCT03343860|"~     In the treatment of symptomatic drug resistant persistent atrial fibrillation (Ps AF),~     catheter ablation has a class IIA indication. During the follow-up, a significant amount of~     patients (~50%) will experience atrial tachycardias (AT) recurrence. The endpoint of AT~     ablation during the second procedure has not been validated. At present, several strategies~     are considered as good clinical practice.~      Main objective: To evaluate if ablation of all inducible AT post AF ablation (ATPAFA) offers~     as substantial benefit in comparison with ablation of the clinical ATPAF only during a redo~     procedure post initial persistent AF ablation.~      Secondary objectives:~      To evaluate the prognosis of non-inducibility during a redo procedure for ATPAFA~   "
17044|NCT03343847|"~     To evaluate the efficacy of romiplostim for the treatment of CIT in patients receiving~     chemotherapy for the treatment of lymphomas measured by the ability to administer on-time,~     full-dose chemotherapy.~   "
17045|NCT03343834|"~     Scientific context~      Epstein-Barr virus has a causal role in the pathogenesis of multiple distinct lymphomas.~     Post-transplant lymphoproliferative diseases (PTLD) are the most frequent EBV-induced~     proliferations. PTLD after allogeneic stem cell transplantation has an incidence lower than~     5% but may increase up to 10-20% in patients with established risk factors. EBV-DNAemia is~     predictive of EBV-PTLD and is routinely performed using qPCR on whole blood. Preemptive~     therapeutic strategies with anti-CD20 antibody are used when patients are above a defined~     EBV-DNAemia threshold. This approach remains limited since it does not discriminate between~     an EBV-induced lymphoproliferation (latent cycle) and/or a replicating virus (replicative~     cycle).~      DNA methylation plays a central role in regulating the switch from latent to lytic gene~     expression. Specific DNA modifications - such as CpG methylation in specific regions of the~     viral genome - can be regarded as molecular signatures for EBV genomes associated with the~     status of the viral infection (latent vs lytic). Accordingly, these signatures may be~     envisioned as a potent tool to characterize the state of the viral infection in vivo.~      Description of the project Our primary objective is to estimate the respective percentages of~     EBV-lytic and EBV-latent genomes (proliferating cells) in patients presenting with a high~     EBV-DNAemia after allogeneic stem cell transplantation HSCT by analysing the methylation~     level of EBV genome on specific sites. Our secondary objectives are i) to determine risk~     factors associated with each latent versus lytic EBV profiles and ii) to correlate the~     latent versus lytic EBV profiles with response to rituximab infusion and patient outcomes.~      For this purpose, a retrospective study (n=80) and a prospective study (estimation n=58) will~     be established. The different steps of this project are:~        1. To study DNA methylation levels by meth-qPCR The laboratory is currently developing a~          rapid and convenient PCR-based assay to quantify hypo/hyper-methylated genome to~          distinguish between latent and lytic genomes. This approach relies on the existence of~          restriction enzymes that are blocked (or not) depending on the methylation of their~          recognition site on specific positions. This study intends to identify several regions~          whose methylation level would characterize the status of the virus ( latent / lytic~          phase).~        2. To realize quantitative analysis by RT-PCR of different EBV transcripts specific of the~          latent or of the lytic phase of the virus This method will be applied on RNA extracted~          from patient blood samples with elevated EBV viral load, under condition preserving RNA~          integrity (trizol frozen blood). The results will be validated on a prospective cohort~          of HSCT patients (n=58) (Saint-Antoine Hospital and La Pitié-Salpêtrière Hospital).~        3. To perform quantitative analysis of EBV genomes in plasma, saliva and total blood~          samples by current routine procedures In addition to total blood samples, plasma and~          saliva will be collected since free viral particles are known to accumulate in these~          biological fluids upon EBV reactivation. These samples will be treated by normalized~          procedures that are routinely used in the medical virology laboratory to quantify EBV in~          human samples.~      Expected results By establishing a simple method for studying the methylation of EBV genomes,~     we expect to understand the significance of high EBV viral load and the pathophysiology of~     post-HSCT PTLD. We aim to distinguish between the latent / lytic profiles of HSCT patients~     and to correlate their respective risks for developing PTLD. Establishing the methylation EBV~     profile in the post-HSCT setting when facing increase viral load and PTLD will improve our~     understanding of the biological mechanisms determining EBV-status in post-HSCT. This should~     improve major medical and economical issues. These results could have a major therapeutic~   "
17046|NCT03343821|"~     The Balance and Daily Life questionnaire (EVQ) observes the adaption of the patient in six~     scenarios of daily life; it is a measurement of falls, but also an evaluation of the~     modifications taken to prevent future falls. This study will analyze the robustness of this~     questionnaire.~   "
17047|NCT03343808|"~     Analyze the results of cooled radiofrequency in patients with chronic knee pain after one~     year of follow- up.~   "
17048|NCT03343795|"~     Preterm birth, defined as delivery at less than 37 weeks gestation, complicates approximately~     12% of pregnancies in the United States~      Preterm delivery has been, and remains, the most important challenge to modern obstetrics. In~     2009, 13 million babies were born preterm, 11 million in Africa and Asia and 500,000 in the~     USA, The highest rates of preterm birth are in Africa (11.9%) and North America (10.6%)~   "
17049|NCT03343782|"~     The purpose of this study is to evaluate the safety and effectiveness of autologous bone~     marrow-derived mesenchymal stem cells transplantation in the treatment of type 2 diabetes~     mellitus~   "
17050|NCT03343769|"~     The quality of life of elderly citizens is to a great extent related to the maintenance of~     independence. The risk of falling and the loss of autonomy are two frequent problems~     associated with ageing. Although the impact of falls on functional outcomes and~     morbi-mortality in the elderly is well-established, the pathophysiological mechanisms~     underlying these falls are poorly understood. To better assess the risk of falling, numerous~     studies have investigated the use of dynamic and static posturography. These studies sought~     to characterise populations of fallers and non-fallers using parameters from postural~     analysis. Nonetheless, a new concept may emerge: weakening of the ankle movement muscles may~     be implicated in the age-related deterioration of posture. Even though it has been shown that~     this decrease occurs earlier and is more severe in fallers, the direct relationship between~     the strength of ankle movement muscles and balance parameters in elderly fallers has not yet~     been established. The existence of such a relationship would make it possible on the one hand~     to facilitate screening for those with a risk of falling, and on the other hand to enrich our~     understanding of the pathophysiology of the risk of falling. The perspective would therefore~     be to propose programmes focused on the strengthening of these deficient muscles.~   "
17051|NCT03343756|"~     All patients having received at least one infusion of the Investigational Medicinal Product~     (IMP) HepaStem HHALPC during a previous interventional clinical study conducted by Promethera~     Biosciences~   "
17052|NCT03343743|"~     Patients with recurrent calcium oxalate stones undergoing endourological procedures for renal~     stones at our institution from June 2013 to June 2014 were considered eligible for enrolment.~     Enrolled patients underwent a baseline unenhanced CT scan before the urological procedure;~     after endoscopic removal of their stones, the patients were instructed to drink at least 2~     L/day of a hypotonic, oligomineral water low in sodium and minerals (fixed residue at 180°C~     <200 mg/L) for at least 12 months. Finally, the patients underwent a follow-up unenhanced CT~     scan during hydration regimen.~   "
17053|NCT03343730|"~     the purpose of this study is to examine whether the deployment of a non-mydriatic color~     fundus camera in a rural prime care setting is feasible and improves the detection rate of~     diabetic retinopathy in patients where adherence rates with recommended ophthalmology~     screening is low.~   "
17054|NCT03343717|"~     The children's susceptibility to respiratory problems is due to their anatomical and~     physiological characteristics; therefore, children with more severe clinical conditions may~     undergo invasive mechanical ventilation (IMV). However, its prolonged use favors tracheal~     injury, barotrauma and / or volutrauma, decreased cardiac output and oxygen toxicity, and~     especially the accumulation of respiratory secretions due to ineffective cough due to~     non-closure of the glottis and damage in the transport of mucus by the presence of the~     tracheal tube. Thus, triggering the development of mechanical ventilation-associated~     pneumonia (VAP), which is defined as a pulmonary infection that arises 48 to 72 hours after~     endotracheal intubation and the institution of invasive mechanical ventilation. As a~     consequence, respiratory work is performed by IMV, reducing the work exerted by spontaneous~     ventilation, causing neuromuscular disorders after 5 to 7 days of IMV, changes in muscle~     mechanics, reducing the capacity of the diaphragm to generate force, thus contributing to~     changes in modulation autonomic heart rate, changes in muscular trophism, generating physical~     deconditioning due to weakness and, finally, an increase in the length of hospitalization and~     immobilism. From this perspective, early mobilization emerges as a rehabilitation mechanism~     to improve muscle strength and joint mobility, as well as to improve lung function and~     respiratory system performance, as well as improved autonomic heart rate modulation. It can~     facilitate the weaning of IMV, reducing hospitalization time and promoting quality of life~     after discharge.~   "
17055|NCT03343704|"~     The primary objective is to demonstrate reversal of the anticoagulant effect of dabigatran in~     patients treated with dabigatran etexilate who have uncontrolled or life-threatening bleeding~     requiring urgent intervention, and in patients treated with dabigatran etexilate who require~     emergency surgery or other invasive procedure.~      The secondary objectives are to assess the reduction or cessation of bleeding, evaluate the~     clinical outcomes, safety and the pharmacokinetics of dabigatran in the presence of~     idarucizumab.~   "
17071|NCT03343496|"~     Awake intubation is the standard of care for the management of the anticipated difficult~     airway.This has traditionally been accomplished using flexible bronchoscopy.~   "
17061|NCT03343626|"~     The purpose of this study is to describe the safety, tolerability and immunogenicity of two~     doses of purified inactivated Zika virus vaccine (PIZV) given 28 days apart. Three different~     vaccine doses containing different protein concentrations (2, 5 or 10 microgram [mcg]) each,~     will be given as 2 dose schedule to flavivirus naive and primed healthy adults. Participants~     will be followed for 7 days post each dose for tolerability and up to 6 months post dose 2~     for safety. Immunogenicity assessment will be performed at 28 days post each dose and 6~     months post dose 2. In addition, the selected dose group and control group will be followed~     till 24 months post dose 2 for safety and persistence of immunity.~   "
17062|NCT03343613|"~     The purpose of this study is to evaluate the safety of the study drug LY3381916 administered~     alone or in combination with anti-programmed cell death ligand 1 (PD-L1) checkpoint antibody~     (LY3300054).~   "
17063|NCT03343600|"~     This study aim at examining whether blocking platelet-derived growth factor receptor-α by~     imatinib lowers the risk of post-allogeneic hematopoietic stem cell transplantation CMV~     infection.~   "
17064|NCT03343587|"~     The purpose of this study is to evaluate how well LY3375880 (study drug) is tolerated in~     healthy participants and what side effects may occur. The study drug will be administered~     either subcutaneously (SC) under the skin or intravenously (IV) into a vein in the arm.~      This is a two-part study. Participants will enroll in only one part. Part one will last about~     16 weeks including screening and follow-up. This part will include 2 nights at the study~     site. Part two will last about 20 weeks including screening and follow-up. This part will~     include 2 nights at the study site for each dose.~   "
17065|NCT03343574|"~     Abnormalities in the regulation of cardiovascular system due to autonomic nervous system~     (ANS) dysfunction may lead to a sudden decline in blood pressure (BP) upon standing, sitting~     or performing activities/exercises in patients with Parkinson's Disease (PD). This sudden~     decline in BP is known as 'orthostatic hypotension' (OH). OH may cause dizziness and/or~     black-outs, which may increase the risk of falls. As falls are potentially dangerous and~     disabling, it is important to prevent their occurrence. Keeping BP within normal range upon~     change of posture or with activities is therefore of great significance. Pooling of blood in~     the abdominal blood vessels may be one of the reasons for OH to happen. This research focuses~     on strengthening the weak abdominal muscles of the participants so that the compressive~     action of these muscles can help decrease such pooling. Therefore, the researchers~     hypothesize that strengthening the abdominal muscles shall prove to be helpful in controlling~     orthostatic hypotension by preventing a sudden decline in blood pressure of the participants~     upon assumption of upright posture. The secondary hypothesis is that there exists a~     significant difference in the response of the cardiovascular system to a variety of~     postures/activities/exercises when patients of PD having cardiovascular autonomic dysfunction~     are compared with patients of PD with normal ANS function.~      This study has two parts - stage 1 and stage 2. Only stage 2 is a randomized controlled~     trial. Stage 1 involves testing the functional integrity of the autonomic nervous system, and~     observation of the cardiovascular responses of the participants to different~     postures/activities/exercises and to the use of an abdominal binder (which is a compressive~     garment worn around the abdomen). Findings of stage 1 shall help the researchers better~     understand the cardiovascular abnormalities present in such patients at rest and with~     activity. Stage 2 involves strength training for the abdominal muscles that is to be done by~     the participant at her/his residence for a period of 3 months followed by a second round of~     autonomic function testing and observation of the cardiovascular responses to the use of~     abdominal binder. Findings of stage 2 shall help the researchers determine if strength~     training of the abdominal muscles can be a useful strategy to counter the cardiovascular~     abnormalities found in the participants during the testing in stage 1.~   "
17066|NCT03343561|"~     Modern way of life characterized by decreased physical activity and poor dietary habits seems~     to be an important trigger for the onset of metabolic disorders. Accumulating evidence~     indicates that the gut microbiota is involved in host metabolism by increasing energy~     extraction, immune system modulation, and altering lipid metabolism, which play an intricate~     role in metabolic disorders, such as obesity and diabetes. Diet has a major role in shaping~     the composition and activity of gut microbiota. Consumptions of whole-grain and~     polyunsaturated fatty acids are known to exert certain extent of impacts on gut microbial~     communities in terms of participants' richness and diversity. In this study, the~     investigators aim to evaluate the impact of dietary intervention on gut microbiome in Hong~     Kong obese population~   "
17067|NCT03343548|"~     Pain after thoracotomy is very severe and may cause pulmonary complications. Thoracic~     epidural analgesia has greatly decreased the pain experience and its consequences. However,~     new ways of decreasing post-operative opioid drugs consumption is an important issue of~     research. We aim to evaluate the effect of adding epidural magnesium sulfate to bupivacaine~     and morphine on pain control and the amount of opioid consumption after thoracotomy. Eighty~     patients undergoing thoracotomy at a tertiary cardiothoracic referral center will be enrolled~     in a randomized double blind trial. Patients randomly will be allocated in two groups.~     Bupivacaine (12.5 mg) plus morphine (2 mg) will be administered epidurally for all patients~     at the end of operation. Patients in group I will be received epidural magnesium sulfate (50~     mg) and patients in Group II will be received normal saline as an adjuvant. Visual analog~     scale (VAS) score and the amount of morphine consumption will be measured during 24 hours~     post-operation.~   "
17068|NCT03343535|"~     To evaluate the safety and effectiveness of the OCS™ Lung System to recruit, preserve and~     assess non-ideal donor lungs that may not meet current standard donor lung acceptance~     criteria for transplantation.~   "
17069|NCT03343522|"~     Introduction: It is well known that the infection caused by the Human Immunodeficiency Virus~     (HIV) is associated to a higher cardiovascular event risk. On the other hand, it is clear~     that the aerobic exercise training induces improvements in autonomic control and vascular~     function, through increases in vasodilator agents and blood vessels number. However, the~     investigators could not find previous works that studied the microvascular function in~     response to exercise training in HIV patients.~      Objectives: To study the impact of aerobic exercise training in endothelial function of HIV~     patients. In addition, the investigators will verify the association of the physical fitness~     to the nitric oxide bioavailability, angiogenesis and lipid profile in HIV patients.~      Methods: The study subjects will be composed by HIV patients, that will be randomly divided~     in two different groups: exercised and sedentary. The subjects will be tested before and~     after training in regards to endothelial function, nitric oxide bioavailability, physical~     fitness and lipid profile, through flowmetry, colorimetric essays, maximal cardiopulmonary~     exercise test, and biochemical tests; respectively. The exercise training will be performed~     in a treadmill for 12 weeks, 3 times a week, 40 minutes each section.~      Expected Results: The investigators expect to achieve markers that will help in understanding~     the interaction of HIV with several factors that contribute to an increased endothelial~     function after exercise training.~   "
17070|NCT03343509|"~     This study aims to determine if topical metronidazole reduces pain more than oral~     metronidazole following excisional haemorrhoidectomy. The trial will be a multi-centered,~     patient and investigator blinded superiority trial with two parallel groups and a primary~     outcome of pain scores during 14 days after surgery.~      Group A will receive oral metronidazole and placebo cream. Group B will receive placebo~     tablets and topical metronidazole cream.~   "
17072|NCT03343483|"~     The many negative outcomes associated with loneliness in older people have rendered~     loneliness itself a new public health target. Older adults who feel lonely carry increased~     risk for reduced quality of life, morbidity, and mortality. The risk of premature mortality~     related to loneliness is at least as large as the risks arising from such factors as obesity,~     physical inactivity, alcohol misuse, and smoking. Volunteering is a promising intervention~     for reducing loneliness in later life. The primary objective of this proposal is to test the~     hypothesis that a social volunteering program for lonely older adults will lead to reduced~     loneliness and improved quality of life. National infrastructure for volunteering (The Senior~     Corps) ensures that volunteering is a highly scalable intervention.~      The investigators propose to compare the effect of a Senior Corps volunteering intervention~     versus a self-guided life review active control condition on feelings of loneliness in older~     adults. The investigators' preliminary data, as well as published studies of volunteering in~     later life, strongly suggest that volunteering should reduce loneliness. Rigorous~     experimental study is needed, however, to examine volunteering in both men and women who are~     lonely, to determine conditions that maximize benefit, and to understand mechanisms. The~     investigators hypothesize, per tenets of Self-Determination Theory, that increased social~     engagement and feelings of both usefulness and social support function as psychological~     mechanisms whereby volunteering reduces loneliness. Understanding these mechanisms will~     promote effective implementation, allowing communities to adapt volunteering programs while~     retaining the active ingredients.~      The study involves randomly assigning older adults (150 women, 150 men) who report loneliness~     to 12 months of either: 1) a structured social volunteering program providing peer~     companionship to frail, homebound older adults for at least 4 hours per week, or 2) an active~     control intervention with self-guided life review.~      Specific aims are as follows: 1) To examine the effect of volunteering on loneliness and~     quality of life; 2) To examine social engagement, perceived usefulness, and social support as~     mechanisms for reducing loneliness; 3) To examine conditions under which volunteering is most~     effective at reducing loneliness.~      The volunteering intervention is already implemented nation-wide, indicating high feasibility~     of going to scale (http://www.nationalservice.gov/programs/senior-corps). If effective,~     volunteering should be prescribed by physicians and promoted by policy. Dissemination and~     scaling up efforts will involve connecting primary care patients and aging services clients~     who are lonely with The Senior Corps, shown to be feasible in the investigators' companion~     study, The Senior Connection. Existing infrastructure will make it possible to reach a large~     proportion of lonely older adults. Reducing loneliness has the potential to improve~     well-being and save lives.~   "
17073|NCT03343470|"~     This is an observational, open, prospective multi-centre study designed to evaluate melatonin~     and cortisol circadian rhythm, immunological profile and anthropometric parameters in Cushing~     Syndrome patients during active Remission state.~   "
17074|NCT03343457|"~     Vitalis was a randomized controlled intervention study that addressed women on long-term sick~     leave in Uppsala County. Participants were on sick leave due to mental illness and/or pain~     and were expected to reach the time limit within the in health insurance. Of the total of 947~     eligible reaching the time limit during 2010-2012 648 persons met the projects inclusion- and~     exclusion criteria and were invited to participate. Of these, 327 persons (50.4%) gave~     informed consent and was thereafter randomly assigned one of the following groups: 1)~     multimodal treatment team (TEAM) 2) psychotherapy with Acceptance and Commitment Therapy~     (ACT), or 3) control group. The main purpose of the study was to facilitate the return to~     work (preventing a return to the public health insurance) and to improve participants' health~     during the project period of one year.~   "
17075|NCT03343444|"~     Randomized, open-label study in treatment naïve and treatment experienced, adolescence to~     determine the efficacy of Sofosbuvir 400mg/ledipasvir 90mg in treatment naïve and~     treatment-experienced adolescence. Hepatitis C virus (HCV) infection as measured by the~     proportion of subjects with sustained viral response 12 weeks after discontinuation of~     therapy (SVR12)~   "
17076|NCT03343431|"~     Most new hepatitis B virus (HBV) infections are acquired perinatally. In this study, pregnant~     women with HBsAg and HBeAg will receive tenofovir disoproxil fumarate during the last~     trimester of pregnancy and for two months following delivery. Their infants will receive~     hepatitis B (HB) immunization, starting with a first dose soon after birth. We hypothesize~     that the risk of mother-to-child transmission of HBV will be lower than 2%. The results of~     the study will help define policy to manage HBV infected pregnant women to prevent perinatal~     transmission.~   "
17077|NCT03343418|"~     The purpose of this study is evaluate the effect of prophylactic desmopressin on blood~     coagulation parameters and postoperative bleeding in patients undergoing valve cardiac~     surgery with cardiopulmonary bypass.~   "
17078|NCT03343405|"~     This pilot-study assesses the feasibility and acceptability of an Online Mind/Body Fertility~     Program, designed to help individuals and/or couples cope with the physical and emotional~     impact of infertility by learning special relaxation strategies and improving lifestyle~     habits. Participants included women experiencing infertility who had not given birth to a~     child. Half of participants received access to the 10-week Online Mind-Body Program and the~     other half were placed on a waiting-list.~   "
17079|NCT03343392|"~     Background: The administration of the intra-oral drugs was not capable of reducing this side~     effect, maybe the use of two analgesics may to present better analgesic effect to avoid the~     bleaching-induced tooth sensitivity (TS). Methods: A triple-blind, parallel-randomized~     clinical trial was conducted with 114 health patients who received either a placebo or an~     association of ketorolac tromethamine/acetaminophen. The first doses of two analgesic~     (Acetaminophen 750 mg/ Ketorolac Tromethamine 10 mg) or placebo was administered 1 h before~     the in-office bleaching (35% hydrogen peroxide), and extra doses were administered every 8 h~     for 48 h. The TS was recorded using 0-10 visual analog scale and a 0-4 numeric rating scale~     in different periods: during bleaching and from 1 h up to 6h, from 12 h up to 18h, from 18h~     up to 24 h, from 24h up to 48 h post-bleaching. The color was measured before and one month~     after dental bleaching with a visual shade guide Vita Classical, Vita Bleachedguide 3D-Master~     and spectrophotometer Vita Easyshade (Vita Zahnfabrik). The absolute risk of TS was evaluated~     by Fisher's exact test. Data of TS intensity with NRS scale of the two groups were compared~     with Mann-Whitney and Friedman tests, while data from the VAS scale were evaluated by two-way~     repeated measures ANOVA and Tukey's test for pairwise comparison. The color changes between~     groups were compared using a Student t-test (α = 0.05).~   "
17080|NCT03343379|"~     Male and female physical education students were subjected to a clinical test battery~     comprised of valid and reliable tests to measure different aspects of core stability at the~     start of the study. After a period of 2 months testing, the injury registration procedure~     started with the use of an online injury registration platform and regular call back moments.~     After 2 years of injury registration, all data was gathered and will be analysed~     statistically to link the measured core stability aspects as risk factors for certain lower~     extremity injuries.~   "
17096|NCT03343171|"~     The primary objective of this study is to obtain implant survivorship and clinical outcome~     data for the commercially available Zimmer® Continuum™ Ceramic-on-Ceramic Bearing System when~     used in primary hip arthroplasty. This will be done by analysis of standard scoring systems,~     radiographs and adverse event records. Data will be used to monitor pain, mobility and~     survivorship, and to confirm the safety and efficacy of the Continuum Ceramic-on-Ceramic~     Bearing System.~   "
17081|NCT03343366|"~     The idea of Mouth-Body Connection has recently been introduced, according to which oral~     health is considered as a vital constituent of general health; like-wise many systemic~     disorders have oral manifestations. Recently it is submitted that incident and prevalent~     chronic periodontal infection, known as chronic periodontitis (CP) possibly has a causal~     relationship with diabetes mellitus (DM) having effects on HbA1c, fasting plasma/ blood~     glucose (FPG/ FBG) and fasting plasma/ blood insulin (FPI/ FBI) levels. Experimental research~     has suggested that treating CP may improve glycemic control and insulin resistance in~     Non-Insulin Dependent Type-2 DM patients (T2DM). However, there is limited data concerning~     the need and effects of adjunct antibiotic therapy (AAT) along with scaling root planning~     (SRP) in treating CP for long lasting results. Therefore, it is suggested that further~     research with larger samples must be undertaken for a successful periodontal therapy that may~     help improve glycemic control at desired levels and longer durations. This study is designed~     to evaluate effects of periodontal therapy [SRP, metronidazole (MET) and oral hygiene~     instructions (OHI)] through three-arm trial experiment comprising of SRP+MET+OHI, SRP+OHI and~     OHI+ Delayed Therapy (DT) groups on HbA1c, FPG, FPI levels and Insulin Resistance calculated~     through Homeostasis Model Assessment (HOMA-IR) to fill research gap. This study will target~     around 1000 patients with CP screened for T2DM at selected Periodontal Clinics of Dow~     University dental hospitals to recruit 150 participants randomly allocated in each group (50~     in each group). Post-therapy follow-up results will be assessed at 1, 3 and 6 months to~     evaluate short and long term changes in status of CP, FPG, FPI and HbA1c.~   "
17082|NCT03343353|"~     Light Emitting Diode (LED) therapy has been investigated in burns and skin ulcers, as it has~     a bactericidal effect and promotes tissue repair. This study aims to evaluate LED therapy at~     different wavelengths in the healing process of graft donor area in adult burn victims.~   "
17083|NCT03343340|"~     Consecutive patients with ACLF (Acute on Chronic Liver Failure) and septic shock with AKI~     (Acute Kidney Injury) who give written informed consent will be included in this prospective~     trial at ILBS. At baseline s, endotoxin levels, NT-Pro BNP, , urine N-GAL will be done for~     all patients. A 10 ml serum sample will be stored for doing a cytokine profile. Septic shock~     will be defined by the presence of two or more diagnostic criteria for the systemic~     inflammatory response syndrome, proven or suspected infection with hypotension non-responsive~     to adequate fluid resuscitation assessed by no evidence of stroke volume variation on flow~     track and need of a vasopressor to achieve a target mean arterial pressure (MAP) of ≥ 65 mm~     Hg. A record of CVP, IVC diameter and B-lines on ultrasound lung would also be done. Patients~     with age less than 18 years, severe known cardiopulmonary disease (structural or valvular~     heart disease, coronary artery disease, COPD) pregnancy, chronic kidney disease, patients~     already meeting emergency criteria for immediate hemodialysis at the time of randomization as~     specified in the late group, patients transferred from other hospitals who have already been~     on hemodialysis before their arrival in the intensive care unit, extremely moribund patients~     with an expected life expectancy of less than 24 hours, failure to give informed consent from~     family members.~   "
17084|NCT03343327|"~     This is a single centre, open label, randomised, two period, crossover study to evaluate the~     bioavailability of Chronocort® versus Cortef® immediate release hydrocortisone tablets in~     dexamethasone-suppressed healthy adult male subjects.~   "
17085|NCT03343314|"~     Although aortic valve replacement is recommended for any symptomatic severe calcific aortic~     stenosis, the therapeutic decision may be difficult. because of patient age and~     comorbidities.~      Transcatheter Aortic Valve Implantation (TAVI) has recently extended the therapeutic~     indications in patients at high risk of surgery. However, the proportion of different~     treatments is not known in a contemporary population that can be treated according to the~     different resources currently available.~      The scientific goal of this observational research is to evaluate intra-hospital therapeutic~     decision in elderly patients referred because of symptomatic severe aortic stenosis.~      The one-year survival will be analyzed according to the therapeutic decision and the~     characteristics of the patients.~   "
17086|NCT03343301|"~     This is a multi-center study to evaluate the safety, tolerability, pharmacokinetics (PK), and~     pharmacodynamics (PD) of FPA144 in combination with 5-fluorouracil, leucovorin and~     oxaliplatin (mFOLFOX6) for patients with gastrointestinal malignancies (GI). The phase 1 open~     label safety run-in will identify a recommended dose of FPA144 to use in the phase 3 portion~     of the trial.~   "
17087|NCT03343288|"~     In this study, CE (European Conformity) marked, domestic manufactured standard orthopedic~     implants will be used after silver HA coating with electrospray method in 30 patients~     requiring hip joint prostheses, intramedullary nails or external fixator in 30 patients to~     antimicrobial effectiveness. These patients will be tasted for liver and kidney functions and~     blood and urine silver levels in addition to routine tests such as full blood, complete~     biochemistry, C-reactive protein, erythrocyte sedimentation rate required in the normal~     diagnosis and treatment processes,~   "
17088|NCT03343275|"~     This study evaluates the effectivity in urinary pH Control and the prevention of~     calcification in Double J catheter using a device combined with the intake of dietary~     supplements. Every patient will receive hygienic-dietary indications.~      Patients will also take one out of the three dietary supplements regarded within the study~     (pH Up, pH Down and Cysteine) to control the adequate pH level, always following medical~     indications.~   "
17089|NCT03343262|"~     Impaired Glucose Tolerance (IGT) is an abnormal metabolic state following glucose metabolic~     steady state but prior to diabetes. IGT is an important stage during the progression of~     diabetes, with an underlying mechanism of insulin resistance and pancreatic β cell~     dysfunction. IGT is one of the diseases that shows significant beneficial response to~     acupuncture treatment. Original findings from the investigators'laboratory show that~     transcutaneous auricular vagus nerve stimulation (taVNS) which is innervated by vagus nerve,~     would enhance the activity of pancreatic β cells, promote the secretion of insulin,~     upregulate the expression of insulin receptors in central as well as peripheral tissues, thus~     to improve glycometabolism. In this study, the investigators would further illuminate the~     mechanism of taVNS at yidan-pi auricular acupoints on the regulation of glucose metabolism,~     its improvement of the IGT state in rat model, as well as its regulation effect on insulin~     receptor expression and insulin resistance, and systematically illustrate the clinical~     effective of this treatment on IGT, with emphasize on its influence on the concentrations of~     glucose and HbA1c, and thus provide an effective proposal for clinical acupuncture.~   "
17090|NCT03343249|"~     Participants will be recruited for the current study during their initial orientation visit~     to the Parkland Health and Hospital System, Stop Smoking Class and Clinic every Monday~     morning. Individuals who are interested and eligible for participation in this study will~     receive uC (Parkland smoking cessation program), plus a tailored, adaptive, smart phone~     delivered smoking cessation intervention. Participants will be followed weekly from 1 week~     pre-quit through 4 weeks post-quit. all participants will be asked to attend 6 weekly visits,~     4 of these visits will include a thorough assessment that may be completed either before or~     after their scheduled Parkland treatment appointments. All participants will receive a~     smartphone at the 1 week pre-quit visit and they will be asked to carry it with them at all~     times. Participants will complete eMa assessments 5 times per day (4 random assessments + 1~     daily dairy) for three consecutive weeks. Geographic location coordinates will be captured~     during each eMa assessment to link characteristics of the neighborhood environment (e.g.,~     neighborhood socioeconomic status, proximity to tobacco outlets) with cessation-related~     outcomes. Participants will be compensated upon the return of the smartphone at visit 4 (2~     weeks post-quit). Participants will be asked to attend a follow-up visit 12 weeks after their~     quit date. At this visit, participants will complete additional questionnaires and their~     smoking status will be assessed. Expired carbon monoxide and weight will also be measured.~   "
17091|NCT03343236|"~     An estimated 1500 people in Sweden will annually be diagnosed with head and neck cancer~     (HNC). Five year survival is approximately 69%. Long-term sequelae are common and in~     particular nutritional problems and fatigue. Radiotherapy (RT) is the cornerstone of~     treatment, either as single modality treatment or combined modality treatment. RT can induce~     immune responses at the site of tumor. It has been demonstrated that RT can lead to a strong~     systemic immune response . We have previously shown that an increase of conventional measures~     of systemic immune response to RT varied significantly across individuals. We predict that~     local immune response plays a major role in the antitumor effect. We also predict that a~     strong systemic immune response contributes to malnutrition and influence on survival. And~     malnutrition may lead to a worse response to RT.~      The overall aim of this multicenter observational longitudinal study is to prospectively~     identify immunological and metabolic variables that affect the outcome of HNC patients. We~     will systematically investigate the local and systemic immune response induced by RT as well~     as explore alterations in metabolite composition induced by disease and treatment through~     global metabolite profiling. A platform for studies on immuno-metabolic changes in HNC~     patients has been established in the Uppsala-Orebro and Northern regions. Approximately 370~     patients per year are eligible. Findings in this study can have implications on the~     development of personalized therapy in patients with HNC. The long-term benefit of the study~     will be the identification of measures for improved patient surveillance in order to improve~     the general and nutritional outcomes.~   "
17092|NCT03343223|"~     The goal of this research study is to evaluate the preliminary impact of a~     public-health-partnered tele-pharmacist model for pre-exposure prophylaxis (PrEP) delivery in~     a rural state (TelePrEP). In brief, PrEP involves daily use of a medication (i.e. Truvada)~     to prevent HIV infection among people at risk for infection due to sexual exposure or needle~     sharing. In this study, PrEP eligible rural and small urban-dwelling public health clients~     wil be enrolled in a prospective study to follow their progression through PrEP care~     following public health referrals. The study will involve a baseline survey to gather data on~     participant beliefs and attitudes about PrEP and a follow up telephone survey 30-40 days~     later to ascertain whether participants have engaged in PrEP. Medical records will be~     requested as a second method to determine whether participants have started PrEP and whether~     they are still using PrEP after six months. The hypotheses that PrEP initiation and retention~     are higher in regions with TelePrEP programs will be tested against control regions.~   "
17093|NCT03343210|"~     Quality of life (QOL) of nursing homes residents with cancer in France is not known. High~     prevalence of neurodegenerative diseases makes it difficult. It was found that oncological~     management is suboptimal among Poitevin territory residents. Publications report an~     inadequate management of symptoms of discomfort related to cancers.~      The multicentric study will comparate quality of life in patients with and without Cancers in~     nursing homes, including residents with neurodegenerative disease, using validated~     questionnaires. These questionnaires, as well as pain evaluation, will be carried out by a~     geriatric consultations' nurse.~   "
17094|NCT03343197|"~     Study to evaluate the suppression of 2-HG (2-hydroxyglutarate) in IDH-1 mutant gliomas in~     resected tumor tissue following pre-surgical treatment with AG-120 or AG-881.~   "
17095|NCT03343184|"~     Treatment clinical trial, randomized, controled, parallel, double-blinded, with four groups,~     that aims to evaluate the best application strategy when using a Universal Adhesive system,~     Single Bond Universal (3M ESPE, USA), in self-etch application mode, with or without enamel~     etching, associated wity a Bulk Fill Composite (Filtek Bulk Fill, 3M ESPE, USA), or with a~     conventional nanofilled composite (Filtek Z350 XT, 3M ESPE). Volunteers will be selected and~     recruited,following inclusion criteria and pre-established exclusion. All volunteers will be~     informed and sign a term of clarification and consent. 50 enrolled patients will receive 200~     Class I or Class II dental restorations, made in four different ways, one from each~     experimental group, using the same universal self-etching adhesive system, with two~     application strategies, under the restorations that will use two different composites, a bulk~     fill composite, used in the bulk strategie, or a nanofiiled composite, used in the~     traditional incremental strategie. Occlusal or Proximo-occlusal lesions will receive the~     selected adhesive system in 2 different protocols separated by groups. Group Self Etching and~     Bulk Fill (SETB), Group Selective enamel etching and Bulk Fill (SEEB), Group Self Etching and~     Filtek Z350XT (SETI), and Group Selective enamel etching and Filtek Z350XT (SEEI).Total time~     used in the restorations will be evaluated during the restorations. Immediate post-operative~     tooth sensitivity will be evaluated after one week. Restorations will be evaluated every 6~     months for pain assessment, shape, fractures, staining or recurrent caries, using scores. To~     determine in which group each tooth will be enrolled, the authors will randomize the teeth.~   "
17097|NCT03343158|"~     Investigators propose to assess the sensitivity, specificity, positive and negative~     predictive value of an HIV Risk Screening Tool in identifying the risk of being HIV-infected~     among Orphans and Vulnerable Children (OVC) aged 2-18 years in a community setting.~   "
17099|NCT03343132|"~     Adaptive gait assessements will be evaluated as a potential new marker for tracking locomotor~     recovery throughout rehabilitation of spinal cord injury subjects. To this end, controls,~     subacute and chronic patients will be assessed at two timepoints with 3 month standard~     rehabilitation inbetween. The specific assessments will require the participant to acitvely~     modulate their gait pattern to fullfill specific task constraints. Their performance will be~     assessed via 3D kinematics, kinetics and EMG and these measures will be used to describe the~     adaptive capacity that the patient retains. Sensitivity and specificity of these markers will~     be determined. With more sensitive descriptors of gait function and quality, locomotor~     rehabilitation for SCI can be better designed and smaller effects can be accurately measured.~   "
17100|NCT03343119|"~     This study investigates carriage rate and risk factors for acquiring multiresistant bacteria~     (ESBL producing E.coli and K.pneumoniae, carbapenem-resistant and multidrug resistant~     P.aeruginosa, MRSA and VRE) in hospitalised patients and healthy volunteers.~   "
17101|NCT03343106|"~     The aim of the study was to evaluate whether integrating Acceptance and Commitment Therapy~     (ACT) with Exposure and Response Prevention (ERP) increases the acceptability, tolerability,~     and adherence with ERP techniques relative to ERP without ACT. Fifty-eight adults with a~     DSM-IV diagnosis of Obsessive-Compulsive Disorder (OCD) received 16 twice-weekly sessions (2~     hours per session) of either ERP with the inclusion of ACT techniques (ERP+ACT; n = 30) or~     ERP alone (n = 28). Assessments using interviews, self-report questionnaires, and behavioral~     observations were conducted at pre- and post-test, and at 6 month follow-up. Specific~     hypotheses were: 1) Patients receiving ERP+ACT will report greater treatment acceptability,~     and show higher quantity and quality of completed self-directed ERP assignments, relative to~     patients receiving standard ERP; 2) Both ERP and ERP+ACT will lead to clinically significant~     reductions in OCD symptoms from pre- to post-test and from pre-test to follow-up.~   "
17102|NCT03343093|"~     Development and evaluation of an online intervention addressing sexual functioning in MSM~     after prostate cancer treatment.~   "
17103|NCT03343080|"~     Researchers will compare the effects of lidocaine versus air, as a way to fill the breathing~     tube cuff which is gently inflated to hold in place the trachea (airway) during surgery. Air~     is the traditional method used to inflate the breathing tube cuff. Researchers wish to find~     if lidocaine works better than air to facilitate tolerance to the breathing tube (decreased~     coughing, sore throat, hoarseness). They also want to learn more about its effectiveness for~     this particular surgical intervention.~   "
17104|NCT03343067|"~     This is a Phase 3, dose-escalation study designed to evaluate the safety and efficacy of both~     elagolix alone and elagolix plus Estradiol/Norethindrone acetate (E2/NETA) over 24 months in~     the management of endometriosis with associated moderate to severe pain in premenopausal~     women.~   "
17105|NCT03343054|"~     This is a Phase 1, open label, dose escalation, safety, preliminary efficacy and~     pharmacokinetic (PK) study of single agent talazoparib in sequential cohorts of adult~     patients with advanced solid tumors who are resistant to standard therapy or for whom no~     standard therapy is available. Successive cohorts of patients will receive escalating doses~     of talazoparib on an outpatient starting from 0.75 mg/day. This study will evaluate 2 dose~     levels; 0.75 mg and 1.0 mg. Treatment with investigational product will continue until either~     disease progression, patient refusal, or unacceptable toxicity occurs. The proposed doses,~     schedule(s), and PK time points may be reconsidered and amended during the study based on the~     emerging safety and PK data.~      In the study overall, up to 18 (minimum 3) patients are expected to be enrolled depending on~     the observed DLTs.~   "
17106|NCT03343041|"~     This pilot study aims to test the tolerability of low-carbohydrate enteral nutrition in~     patients with bacterial septic shock.~   "
17107|NCT03343028|"~     The purpose of Biomarker Establishment for Superior Treatment of PTSD is to accelerate~     research on the discovery of biological, neurological and neuroimaging markers for Post-~     Traumatic Stress Disorder (PTSD). The investigators hope to validate and extend the network~     efficiency and verbal memory biomarker for PTSD. The investigators hope to learn whether~     there are pretreatment biological factors that can predict response to therapy. They want to~     do this by understanding the brain network function, relating EEG to functional magnetic~     resonance imaging, and application of network analysis tool.~   "
17108|NCT03343015|"~     Patients with complete dentures were examined after the prosthoddontic treatment with two~     methods of establishing a centric relation: wax rims and gothic arch tracing method. The~     effectiveness of establishing a centric relation was evaluated.~   "
17109|NCT03343002|"~     Fentanyl is a commonly used drug for the prevention of emergence agitation and reduction in~     postoperative pain in children receiving tonsillectomy. However, fentanyl can cause~     postoperative nausea and vomiting (PONV), which is a main target side effect that medical~     staff strives to prevent. However, recent meta-analysis showed that the incidence of PONV may~     be different depending on the time of administration of fentanyl. However, the research~     design of patients enrolled in each study, such as the age, the name of the operation, and~     the method of anesthesia, is not identical. The aim of this study was to evaluate the~     efficacy and safety of fentanyl in patients undergoing tonsillectomy with a prospective~     randomized controlled trial. Secondary outcomes include incidence and severity of emergence~     agitation and anesthesia recovery time, postanesthesia care unit (PACU) time, side effects.~   "
17110|NCT03342989|"~     In this proposal, we will examine processing speed training (PST) as a potential intervention~     to reduce the risk of developing long-term cognitive impairment after a delirium episode.~   "
17111|NCT03342976|"~     This is a multicenter, multicultural, randomized control trial. Participants will be~     recruited from 10 centers located in Italy, Germany, Austria, Spain, United Kingdom, Belgium,~     Sweden, Japan, South Korea and Australia. The main objective of the study is to examine the~     efficacy of a sensor-based platform (my-AHA platform) to assess frailty risks and to deliver~     tailored interventions in order to prevent in elderly subjects conversion from a pre-frail~     status to a frailty status.~   "
17112|NCT03342963|"~     To investigate the bioequivalence of aripiprazole between administration of one ASC-01 tablet~     (aripiprazole 3 mg/sertraline 100 mg combination drug) and concomitant administration of one~     aripiprazole 3-mg tablet and two sertraline 50-mg tablets (Cohort 1).~      To investigate food effect on plasma pharmacokinetics of aripiprazole and sertraline by~     single oral administration of ASC-01 under a fasting or fed condition (Cohort 2).~   "
17113|NCT03342950|"~     Microvascular dysfunction underlies pain in different animal models of neuropathic pain.~     Pentoxifylline is a phosphodiesterase inhibitor that reduces cyclic adenosine monophosphate~     (cAMP) hydrolysis, enhances blood flow and reduces platelet aggregation, decreases blood~     viscosity, and increases the flexibility of red blood cells, all of which relieve~     microvascular dysfunction. Clonidine is an α2-adrenergic receptor agonist that decreases~     sympathetic outflow from the brainstem, vascular reactivity and has direct peripheral~     vasodilatory action. Topical combination of pentoxifylline and clonidine produced significant~     antiallodynic effects in rat models of neuropathic pain with sciatic nerve injury, painful~     diabetic neuropathy, and chemotherapy-induced painful neuropathy. In healthy volunteers with~     an experimentally-induced surrogate for neuropathic pain: post-capsaicin tourniquet exposure,~     the topical combination reduced areas of dynamic allodynia and mechanical hyperalgesia, in~     addition to reducing post-capsaicin ischemic pain.~      This study will investigate if the same topical combination of clonidine + pentoxifylline~     will relieve pain in patients with neuropathic pain following traumatic injuries of~     peripheral nerves.~   "
17114|NCT03342937|"~     This study will be conducted in two stages: 1) safety validation and 2) dose expansion~        1. Safety Validation Cohort: The first portion of the study will preliminarily establish~          the tolerability of the combination of pembrolizumab, oxaliplatin and capecitabine. Five~          (5) subjects will be enrolled and their safety data after 21 days of treatment will be~          reviewed before additional subjects are enrolled. Subjects on this portion of the study~          will only be enrolled at the Duke Cancer Institute.~        2. Dose Expansion Cohort: The second portion of the study (ie. phase II) will enroll 30~          subjects. In the dose expansion cohort, the first cycle will be modified to allow one~          week of pembrolizumab monotherapy before starting capecitabine and oxaliplatin (XELOX)~          chemotherapy, which will allow analysis of biomarkers related to pembrolizumab. Subjects~          on this portion of the study will be enrolled at the Duke Cancer institute and select~          external collaborating institutions.~      The primary objective of this trial is to describe the progression free survival (PFS)~     associated with the combination of pembrolizumab, oxaliplatin and capecitabine (pembrolizumab~     +XELOX) in all patients with previously untreated metastatic esophagogastric adenocarcinoma.~   "
17115|NCT03342924|"~     Cognitive Control is crucial for learning and development. This study examined the~     associations between cognitive control and physical fitness and body composition among ethnic~     minority children.~   "
17116|NCT03342911|"~     This phase II trial studies how well nivolumab, carboplatin, and paclitaxel work in treating~     patients with stage III-IV head and neck squamous cell carcinoma that can be removed by~     surgery. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor~     cells to grow and spread. Drugs used in chemotherapy, such as carboplatin and paclitaxel,~     work in different ways to stop the growth of tumor cells, either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading. Giving nivolumab,~     carboplatin, and paclitaxel may work better in treating patients with head and neck squamous~     cell carcinoma.~   "
17117|NCT03342898|"~     The main purpose of this study is to assess the immunogenicity and safety of the concomitant~     and sequential administration of yellow fever (YF) vaccine and tetravalent dengue vaccine~     (TDV) in healthy participants aged 18 to 60 years living in country(ies) non-endemic for both~     dengue and YF.~   "
17118|NCT03342885|"~     The aim of this study is to investigate the effect of sleep ergonomics guidance given by~     physiotherapist on pain and disability in patients with low back pain. In this randomized~     controlled trial participants are assigned either into the intervention or the control group.~     The intervention group will receive detailed instruction on sleeping ergonomics whereas the~     control group will only be instructed to avoid painful sleeping posture. The initial~     hypothesis is that in the intervention group pain and disability will decrease more compared~     to the control group.~   "
17119|NCT03342872|"~     National mandates for increasing accountability in behavioral healthcare have created an~     urgent need for effective quality assurance (QA) procedures featuring pragmatic measures of~     treatment implementation quality in usual care (UC). The most practical method for assessing~     treatment quality in UC is therapist self-report; unfortunately, therapist-report measures of~     fidelity to evidence-based practices (EBPs) have demonstrated weak validity to date. This~     study addresses this need for effective QA procedures by first developing treatment quality~     assurance procedures designed to increase the adoption and quality of empirically supported~     family-based services (FBS) for adolescent substance use (ASU) in usual care, and then~     testing two system-level implementation strategies for installing the new quality procedures~     in ASU treatment sites.~      FBS have achieved the strongest evidence base for treating ASU and are a prime candidate for~     upgrading the quality of ASU services in various systems of care. FBS comprise both family~     participation in services, the systemic parameters wherein family members are included in~     assessment and treatment activities; and family therapy techniques, the specific~     interventions that clinicians use to directly target family members and family functioning~     for change. For FBS to fulfill their potential to enhance ASU treatment systems, FBS~     implementation must be supported by effective quality assurance procedures designed to ensure~     that FBS are delivered with fidelity. The proposed study will leverage a strong~     research-government partnership between the applicant organization and the New York~     single-state agency for SU services.~      The study will first develop innovative quality procedures (Aim 1) that use existing FBS~     quality metrics to promote high-fidelity FBS: Measurement Training and Feedback System for~     Implementation (MTFS-I), a pragmatic evidence-based method for increasing FBS quality by~     providing monthly feedback on therapist-reported FBS delivery along with brief online FBS~     training modules. The study will then experimentally compare two system-level implementation~     strategies designed to foster MTFS-I utilization in usual care for ASU. Core Training Only~     will contain two 3-hour training sessions: Mapping existing FBS and identifying site goals~     for FBS improvement; and Installing and sustaining the MTFS-I. Core + Facilitation is an~     additive strategy that will begin with the Core Training sessions and then continue with~     monthly facilitation meetings for one year to promote MTFS-I use and progress toward FBS~     improvement.~      The study will feature a three-group cluster randomized trial testing Core Training Only~     versus Core + Facilitation versus no-intervention Control in 9 ASU clinics across New York~     State. MTFS-I utilization data will be collected from Core Training and Core + Facilitation~     sites for one-year follow-up (after initial Core Training); FBS quality data on family~     participation and family therapy technique use will be collected from all sites over one-year~     follow-up; observational coding methods will verify therapist reports of FBS quality; and~     client outcome data for all sites will be retrieved from administrative data warehouses over~     one-year baseline and one-year follow-up. These data will enable between-condition~     comparisons of FBS delivery (Aim 2: MTFS-I utilization, family participation, family therapy~     technique use) and client outcomes (Aim 3: therapeutic goal achievement, substance use~     change). If study aims are achieved, investigators would be positioned to mount a fully~     powered RCT to test the effectiveness of these FBS quality improvement procedures at scale.~   "
17120|NCT03342859|"~     To investigate the clinical effects of vilaprisan and ulipristal acetate at molecular and~     cellular level on uterine and fibroid tissue taken from patients (after hysterectomy/biopsy)~   "
17121|NCT03342846|"~     The aim of the study is to compare high versus low frequency rTMS on motor dysfunction in PD.~     Forty patients with PD participated in the study.~      The patients were randomly assigned into two groups; the first group received 1Hz and the 2nd~     one received 20 Hz rTMS daily for 10 days 5 sessions every week. The doctors who assess the~     patients clinically is blind for the frequency of rTMS, also patients don't know which type~     of stimulation they received. The patients were followed up before and after the 10 sessions~     and one month later.~   "
17122|NCT03342833|"~     The purpose of this current study proposal is to identify the potential physiological~     adaptations arising from a combined BFR+HIIT training intervention in CHF patients. We~     hypothesise that the addition of BFR to HIIT will increase whole-body V̇O2peak by promoting~     vascular and skeletal muscle adaptations above that seen with HIIT alone. The secondary~     outcomes of this study are to determine if such a training intervention leads to clinical~     improvements in exercise intolerance symptoms and quality of life indices. Given that the~     majority of previous research in to both BFR and HIIT has largely involved young, healthy and~     relatively active participants, the final objective of this current proposal is to determine~     the viability, tolerability and efficacy of these training modalities in an elderly cohort of~     predominantly sedentary CHF patients.~   "
17123|NCT03342820|"~     This study evaluates the effects of an isokinetic fatigue protocol of the quadriceps on the~     amount of co-contractions of this last with the hamstrings during a maximal isometric flexion~     movement in hemiparetic stroke patients.~      The effect of such a protocol on gait parameters and spasticity of the quadriceps will be~     evaluated also.~   "
17124|NCT03342807|"~     To investigate an economical and effective way to reduce the level of serum triglyceride in~     patients with hypertriglyceridemia-induced acute pancreatitis.~   "
17204|NCT03341767|"~     This study evaluates the safety, tolerability, pharmacokinetics, and efficacy of treating~     Cryptosporidiosis in HIV positive patients with Clofazimine. Half of the HIV positive~     patients with Cryptosporidiosis enrolled will be treated with Clofazimine while the other~     half will be given placebo. An additional group of HIV positive patients without~     Cryptosporidium infection or diarrhea will be given Clofazimine to assess the differences in~     pharmacokinetics between HIV positive patients with and without Cryptosporidiosis and~     diarrhea.~   "
17125|NCT03342794|"~     Few descriptive studies have focused on the anatomical parameters in patients with~     preexisting PCDs. The characteristics of cataract morphology and anatomical parameters in~     these patients remained unclear, when compared with CC patients with intact posterior~     capsule. We conduct the current study to compare the cataract morphology and preoperative~     parameters, including central corneal thickness, axial length, anterior chamber depth, lens~     thickness, corneal diameter, keratometry，dialated pupil diameter and intraocular pressure,~     between CC patients with preexisting PCDs and those with intact posterior capsule, and to~     explore potential risk factors for preexisting PCDs.~   "
17126|NCT03342781|"~     The investigators compared oxygen therapy using the HFNC and diffuser mask (an effective~     low-flow oxygen delivery system) to treat patients with moderate-to-severe acute~     bronchiolitis admitted to an intensive care unit (ICU).~   "
17127|NCT03342768|"~     The study aims to test the effect a smartphone-based intervention on primary school students~     and their parents' attitudes towards tobacco industry and their tobacco-related~     communications.~   "
17128|NCT03342755|"~     The study aims to analyzing the impact of the staged endovascular treatment (divided into two~     or more distinct procedures) of thoracoabdominal aneurysmatic pathology on short and medium~     term, technical and clinical outcomes and on the possible benefits or complications~     associated with this approach.~   "
17129|NCT03342742|"~     The proposed research will determine the feasibility of delivering two behavioral weight loss~     interventions for 1 year in adults with autosomal dominant polycystic kidney disease (ADPKD)~     who are overweight or obese. The study will also compare these two interventions in terms of~     safety, acceptability, and tolerability. Last, this pilot trial will provide initial insight~     into a) biological changes and b) changes in kidney growth with each of the two weight loss~     interventions.~   "
17130|NCT03342729|"~     The Aging Mastery Program® (AMP) is designed to inform, encourage, and support older adults~     as they take steps to improve their lives and stay engaged in their communities. The program~     incorporates evidence-informed materials, expert speakers, group discussion, peer support,~     and small rewards to give participants the skills and tools they need to achieve measurable~     improvements in managing their health, remaining economically secure, and contributing~     actively to society. L.A. CAPRA in partnership with the National Council on Aging, City of~     Los Angeles and the Los Angeles County Department of Aging will evaluate the effectiveness of~     the AMP program across 5 community-based senior sites. The overall objective of the proposed~     study is to evaluate the effectiveness of AMP program on improving the health and well-being~     of older adults using a randomized wait-list controlled trial.~   "
17131|NCT03342716|"~     Acute pancreatitis (AP) is inflammation of the pancreas usually triggered by gallstones or~     drinking excessive alcohol. 80% of people who have an episode of AP will recover without~     complications. However, 20% will require treatment in high dependency or intensive care for~     multiple organ dysfunction (AP-MODS). It is known that this negatively affects recovery and~     can have a lasting effect on health although it is incompletely understood what causes this.~      Aim: To recruit 500 patients with acute pancreatitis. Participants will be assessed at~     recruitment and and again at 3 and 27 months. Recovery of organ function will be serially~     measured and the presence of novel factors important in recovery assessed.~   "
17132|NCT03342703|"~     The investigators will assess the ability of ultrasound (US) to measure liver stiffness~     (cirrhosis) and liver fat content (steatosis).~   "
17133|NCT03342690|"~     Secondary Data Collection Study; Safety And Effectiveness Of Selara Under Japanese Medical~     Practice~   "
17134|NCT03342677|"~     Chronic liver disease including cirrhosis is one of the most important factors in the~     multi-step progression of hepatocarcinogenesis, from benign regenerative nodules to early~     hepatocellular carcinomas (HCCs) and finally to overt HCCs. Early diagnosis of HCC,~     differentiation from benign hepatocellular nodules, and surgical resection of the tumor or~     transplantation of the liver provide the best chance for long-term survival. Several studies~     have evaluated MRI enhanced with superparamagnetic iron oxide, gadolinium-based contrast~     material, or both, for the detection and differential diagnosis of focal hepatic lesions.~     However, the differentiation of HCC from benign and or borderline hepatocellular nodules~     remains difficult, particularly in patients with cirrhosis, because of the architectural~     distortion of liver parenchyma and the development of cirrhotic nodules, ranging from benign~     regenerative nodules to overt HCC, with overlapping imaging features. Recently, gadoxetic~     acid (gadoliniumethoxybezyl-diethylenetriamine pentaacetic acid; Primovist®, Bayer Health~     Care Pharmaceuticals), a gadolinium-based paramagnetic contrast agent that produces both~     dynamic and liver-specific hepatobiliary MRI studies has gained widespread use. Some studies~     have showed that gadoxetic acid-enhanced MRI allows the accurate detection and~     characterization of HCC. Investigators plan to assess this in particular as it is a question~     of great relevance. Execution of well conducted prospective studies will also clarify~     inclusion of Gd-EOB-DTPA enhanced MRI as the technique of choice in evaluation of patients at~     risk for HCC.~   "
17135|NCT03342664|"~     The primary objective of this multicenter randomized controlled study is to compare the~     safety and efficacy of minimally invasive hematoma evacuation with the Artemis Neuro~     Evacuation Device to best medical management for the treatment of intracerebral hemorrhage~     (ICH).~   "
17136|NCT03342651|"~     Vitamin D deficiency is a commonly observed health problem in the world. With a role in many~     chronic diseases and especially lung diseases, the importance of vitamin D deficiency in~     anesthesia management is increased. This research aims to investigate whether there is a~     correlation between the respiratory complications occurring in patients under general~     anesthesia and preoperative vitamin D levels.~   "
17162|NCT03342313|"~     A randomized cross-over design aims to investigate chewing activities between healthy vs.~     overweight and determine effects chewing times on energy intake and postprandial plasma~     glucose and insulin. Forty-one participants were allocated into lean and overweight groups~     according to BMI. Phase I, Bite size (g/bite), bite rate (bites/min), chewing frequency~     (chews/min), and chews (chews/g food) were recorded after a sandwich breakfast. Phase II,~     gram of sandwich eaten ad libitum after 15 and 50 chew per bite (number from phase I) were~     recorded. Postprandial plasma glucose and insulin were examined at 0 (baseline), 30, 60, 90,~     120 and 180 min.~   "
17206|NCT03341741|"~     To assess whether the inhalative combination of Tobramycin/Colistin is more effective in~     reducing Pseudomonas colony forming units (CFUs) and improvement of lung function than~     Colistin in mono-therapy.~   "
17137|NCT03342638|"~     Multiple sclerosis (MS) is at onset an immune-mediated demyelinating disease. In most cases,~     it starts as a relapsing-remitting disease with distinct attacks and no symptoms between~     flares. Over years or decades, virtually all cases transition into a progressive disease in~     which insidious and slow neurologic deterioration occurs with or without acute flares.~     Relapsing-remitting disease is often responsive to immune suppressive or modulating~     therapies, while immune based therapies are generally ineffective in patients with a~     progressive clinical course. This clinical course and response to immune suppression, as well~     as neuropathology and neuroimaging studies, suggest that disease progression is associated~     with axonal atrophy. Disability correlates better with measures of axonal atrophy than immune~     mediated demyelination. Therefore, immune based therapies, in order to be effective, need to~     be started early in the disease course while MS is predominantly an immune-mediated and~     inflammatory disease. While current immune based therapies delay disability, no intervention~     has been proven to prevent progressive disability.The investigators propose a randomized~     study of autologous unmanipulated peripheral blood hematopoietic stem cell transplant (HSCT)~     comparing two different conditioning regimens: (1) cyclophosphamide and rabbit~     anti-thymoglobulin (rATG) versus (2) cyclophosphamide, rATG, and Intravenous Immunoglobulin~     (IVIg).~   "
17138|NCT03342625|"~     Monocentric prospective study evaluating the efficacy of High intensity focused ultrasound~     (HIFU) in breast tumors.~   "
17139|NCT03342612|"~     Mild Traumatic Brain Injury (mTBI), including concussion, is a real public health problem.~     Indeed mTBI might induce long-term brain disorders with increased risk of neurodegenerative~     diseases and the healthcare costs can be significant for both the individual and the society.~     However mTBI is called the silent epidemic, because of the lack of research in this field~     in France as well as in the rest of the world. Most of the time, mTBI is associated with~     sports injuries, road traffic accidents and falls. The risk of neurodegenerative diseases is~     significantly increased with the repetition of mTBI, which may have a cumulative effect. In~     this context, playing football (or 'soccer') is associated with a high risk of concussion and~     with frequent head-ball contacts which are repeated during the training and matches.~     Moreover, football is the most popular team sport in the world, with more than 265 million~     players. The long-term impact of heading in football is still debated in the literature.~     Nevertheless, several studies suggest the possible emergence of early neurocognitive~     disorders. Otherwise, while mTBI is usually characterized by normal brain images using~     traditional neuroimaging techniques, microscopic anatomical changes might be detectable by~     new neuroimaging techniques. According to recent studies, cognitive dysfunctions could be~     based on these microstructural changes in the gray matter and white matter, secondary to the~     primary mechanical injury. Studies that have examined the structural changes in the brain~     white matter in football players are rare and lack of evidence regarding the consequences of~     accumulated brain impacts explains the lack of preventive measures in this sport. In~     addition, post-traumatic secondary lesions cause functional alterations of the neurovascular~     unit and its effect on cerebral perfusion may play a crucial role, which has never been yet~     explored in humans over the long term.~      In this research, the investigators will develop a unique multi-modal neuroimaging protocols~     to assess brain changes after minor head trauma and over the time. Investigators want to~     perform magnetic resonance imaging (MRI) to assess cerebral blood flow using Arteria Spin~     Labelling (ASL), structural changes using Diffusion Tensor Imaging (DTI), susceptibility~     weighted imaging (SWI), and functional changes using BOLD resting-functional MRI.~   "
17140|NCT03342599|"~     Eight weeks supplementation of alpha lipoic acid (known superantioxidant already produced by~     the body) will significantly improve metabolic syndrome markers (e.g., excess body weight,~     blood pressure, glucose, insulin, blood lipids, and self-report measures) in young (18-25~     years) overweight or obese males compared to placebo (cellulose starch). If the hypothesis is~     supported, alpha lipoic acid ingestion could be beneficial in reducing disease risk and~     enhancing metabolic dysfunction in ethnic individuals. Therefore, the purpose is to establish~     the impact alpha lipoic acid has on the modifiable markers associated with metabolic~     perturbations consistent with metabolic syndrome in males.~   "
17141|NCT03342586|"~     The purpose of this study is to test resting state functional Magnetic Resonance Imaging~     (rsfMRI) scans to see if rsfMRI scans are better than the standard task based fMRI scans at~     diagnosing or monitoring central nervous system lymphoma.~   "
17142|NCT03342573|"~     The primary objective of this study is to assess the potential effectiveness of Cosentyx in~     the treatment of adult-onset Pityriasis Rubra Pilaris or PRP.~   "
17143|NCT03342560|"~     Chronic liver disease is a major problem in the general population and there is an unmet need~     to diagnose(and screen) for liver disease with using noninvasive, cost-effective and~     sensitive techniques.The investigators hypothesize that variation using ultrasound~     elastography for the estimation of stage of liver fibrosis and steatosis in patients with~     diffuse liver disease exists due to different methods of measurements, and/or different~     systems. The proposed investigation is a cross-sectional study using ultrasound elastography~     and fat quantification modalities. The investigators are planning to enroll 30 subjects 18~     years old and older in whom diffuse liver disease is suspected, and who have undergone~     non-focal liver biopsy in the past 6 months or are scheduled to undergo biopsy within 3~     months of enrollment, as part of their routine clinical care. The investigators will use 4~     different ultrasound devices with their shear wave elastography and speed of sound functions.~      Specific aims;~        -  Compare shear wave elastography(SWE) measurements from different ultrasound systems;~          using histopathology as reference standards.~        -  Assess intra-operator and inter-operator reliability by measuring variability in~          elastography values by two operators on a single system.~        -  Determine the steatosis effect on liver disease, with using speed of sound(SoS) mode~        -  Determine the effect of deviations from guidelines(less number of measurements and~          measurements during active breath)~   "
17163|NCT03342300|"~     Advanced soft tissue sarcoma patients who have previously recieved anthracyclines might still~     benefit from doxorubicin, ifosfamide and dacarbazine. However doxorubicin might be stopped~     using because of chronic cumulative heart toxicity. Several efforts have been made to improve~     the toxicity profile of conventional anthracyclines, including the use of liposomal~     encapsulation technology and the development of novel anthracycline analogs,such as pegylated~     liposomal doxorubicin and pirarubicin. However their actual effectiveness and toxicity have~     not been studied in prospective trial. The purpose of the study is to investigate whether~     they are available for this group of patients.~   "
17164|NCT03342287|"~     Irritable Bowel syndrome - constipation predominant (IBS-C) is a chronic and~     disabling,disorder of the gut that is characterized by abdominal pain or discomfort.~     Approximately 50% of patients with IBS-C will also meet criteria for anxiety or depression.~      Anti depressant medication is widely used in the treatment of IBS. Linaclotide is a novel~     medication for IBS that is also effective at relieving pain associated with IBS, which may be~     in part to signalling between the gut and the brain. However, the impact of Linaclotide on~     the psychiatric symptoms of anxiety and depression on IBS has not been investigated.~   "
17144|NCT03342547|"~     The primary objective in this study is to establish a list of host cellular proteins that~     mediate norovirus infection.~      Norovirus is one of the most common pathogens attributed to diarrheal diseases from unsafe~     food. It is also the primary cause of mortality among young children and adults in foodborne~     infections. Norovirus is not just a foodborne burden. In a recent meta-analysis, norovirus~     accounts for nearly one-fifth of all causes of (including person-to-person transmission)~     acute gastroenteritis in both sporadic and outbreak settings and affects all age groups.~     Undoubtedly, norovirus is of paramount public health concern in both developed and developing~     countries. Research efforts to better understand norovirus pathobiology will be necessary for~     targeted intervention.~      From Middle East respiratory syndrome coronavirus to Zika virus, efforts to identify host~     factors important for mediating virus infection has always been a research priority. Such~     information will shed light on potential therapeutic targets in antiviral intervention.~     Norovirus virus-host interaction studies have been hampered by the lack of a robust cell~     culture model in the past 20 years. In 2016, norovirus has finally been successfully~     cultivated in a stem cell-derived three-dimensional human gut-like structure called enteroid~     or mini-gut.~      In this study, intestinal stem cells will be isolated from duodenal biopsies collected from~     participants, followed by differentiation into mini-guts. Genome-wide genetic screening for~     host essential and restrictive factors will be performed on infected mini-guts by knockout~     CRISPR and gain-of-function CRISPR SAM, respectively. Shortlisted candidates will undergo~     preliminary functional validation in cell lines. These data will provide insights into~     potential therapeutic targets against norovirus infection.~   "
17145|NCT03342534|"~     Neurological deficits and motor disorders are extremely common after stroke. Physical~     therapies can improve the autonomy of these patients, but despite an intensive stationary~     neurorehabilitation, severe deficits often persist. Complementary therapies that could~     improve recovery would therefore be very welcome.~      Transcranial direct current stimulation (tDCS) induces, in a non-invasive way, a transient~     inhibitory or excitatory neuromodulation of certain cerebral regions. An increasing number of~     studies show that this modulation of brain activity can improve motor functions in patients~     with brain lesions and increase the effect of physical therapies. However, the optimum~     configuration of tDCS and the induced effects remain to be characterized and investigated.~      The investigators therefore propose to carry out a study including a pilot phase in order to~     determine the most efficient tDCS setup. The optimum setup of of the pilot phase will be~     compared to a placebo condition in a multicentric main study.~   "
17146|NCT03342521|"~     The management of ST-elevation myocardial infarction in the acute phase requires an optimal~     antiaggregation combining aspirin and a P2Y12 inhibitor (clopidogrel, prasugrel or~     ticagrelor). Primary percutaneous coronary intervention must be performed within 2 hours of~     first medical contact. However, even with the new P2Y12 inhibitors, effective platelet~     inhibition which is required to inhibit the progression of intracoronary thrombus, is present~     only in half of the patients at 2 hours.~      Optical coherence tomography (OCT) is the reference method for visualizing and quantifying~     intracoronary thrombus. The post-stenting intracoronary residual mass evaluated in OCT was~     associated with altered myocardial reperfusion indices, which were themselves associated with~     the prognosis of the patient. However, the determinants of this post-stenting residual mass~     -mostly thrombotic- remain unknown.~      Measurement of platelet reactivity (expressed as P2Y12 Reaction Unit and Aspirin Reaction~     Unit) by simple turbidimetric tests (VerifyNow) is available in the cathlab. Enhanced~     platelet reactivity is reported in patients with acute coronary syndrome and represents a~     high-risk situation for recurrent coronary events in this setting.~      The study aims to:~        1. to evaluate the relationship between the post-stenting residual intracoronary mass~          evaluated in OCT and the platelet response at the time of the PCI evaluated by Verify~          Now~        2. to confirm the impact of the residual mass measured by OCT on the EKG and angiographic~          myocardial reperfusion indices~        3. identify patients with high thrombotic risk who may require more intensive~          antithrombotic therapy~        4. identify simple biological markers associated with the residual mass measured by OCT~   "
17147|NCT03342508|"~     The purpose of this study is to evaluate outcomes following cesarean delivery for failure to~     progress with the use of the Fetal Pillow. Our hypothesis is that time to delivery of the~     fetus is shorter with implementation of the Fetal Pillow.~   "
17148|NCT03342495|"~     The Transition Navigator Trial (TNT) is a pragmatic randomized controlled trial evaluating~     the effectiveness of usual care plus a patient navigator service versus usual care plus~     newsletters and other educational materials, to improve transition outcomes among adolescents~     aged 16-21 who have chronic health conditions requiring transfer to adult specialty care.~      The study will provide urgently needed data to guide health care providers and policy makers~     regarding the provision of coordinated transition care. These results have the potential to:~        1. Change care delivery~        2. Improve health outcomes~        3. Improve the experiences of young adult transition to adult care~   "
17149|NCT03342482|"~     The objective of the proposed research is to examine whether dietary exposure to food~     additives containing glutamate may be contributing to symptoms in Gulf War Illness (GWI). The~     rationale for proposed study comes from data in the fibromyalgia field which suggests that~     reducing the consumption of dietary glutamate can reduce over-excitation in the nervous~     system, leading to symptom improvement. In prior research, a low-glutamate diet (restricting~     food additive consumption) was tested in fibromyalgia patients. After one-month on the diet,~     84% of patients had >30% of their symptoms go away (with 11 symptoms remitting on average),~     and 8 subjects had complete remission of all symptoms. Subjects then had a significant return~     of symptoms upon challenge with monosodium glutamate (MSG) as compared to placebo. Since~     there is almost complete symptom overlap between fibromyalgia and GWI, it is of utmost~     importance to test this diet as a low-cost treatment option in GWI patients.~      The findings from this research will ultimately be applicable to all GWI patients and~     potentially to other veterans with a similar symptom profile as well. The ultimate impact of~     this research could be quite profound, as it has the potential to impact all of the symptoms~     of GWI, as opposed to being a proposed treatment for only one of the symptoms. This dietary~     treatment has been shown to dramatically affect symptoms like fatigue, cognitive dysfunction,~     and pain; and thus, has the potential to dramatically improve quality of life for these~     individuals. Potential benefits of the treatment are great, and risks are minimal, as the~     treatment involves shifting the diet to a healthier, whole-food approach.~      First, the study will confirm or negate the idea that abnormal glutamate signaling in the~     nervous system could be causing symptoms in GWI. Second, if found to be successful, then this~     will provide a low-cost, easy-to-implement treatment option for the many veterans suffering~     from this multi-symptom illness. Third, this research could lead to future studies to~     identify potential causes of this abnormal neurotransmission, to help prevent future illness~     onset.~   "
18978|NCT03318523|"~     To evaluate the dose-related safety of BIIB054, to evaluate the pharmacodynamic effects of~     BIIB054 on the integrity of nigrostriatal dopaminergic nerve terminals, to assess the~     pharmacokinetic (PK) profile of BIIB054 and to evaluate the immunogenicity of BIIB054.~   "
17151|NCT03342456|"~     Helicobacter pylori (Hp) infection is one of the important causes of gastrointestinal~     diseases, including gastritis, peptic ulcer, and malignancies, nd the eradication of Hp can~     effectively cure or prevent these diseases. Now, owing to the increasingly serious antibiotic~     resistance, Hp eradication rate is, however, becoming decreased. In order to improve the~     eradication rate of Hp, clinicians pay great attention to choose more effective treatment.~      Ilaprazole Enteric-Coated Tablets is a new generation of proton pump inhibitor (PPI).~     Previous research found that Ilaprazole had a more prolonged half-life and higher suppression~     of gastric acid secretion. In addition, its metabolism is not significantly influenced by~     CYP2C19, compared to the available PPIs. Doxycycline is in the tetracycline antibiotic class,~     has a stronger antibacterial force than tetracycline and its antibacterial spectrum is~     basically the same as tetracycline and doxycycline, so far, it is not widely used.~     Preliminary observations showed that Ilaprazole/Doxycycline-based quadruple therapy was~     effective in treating Hp infection, with less adverse reactions and good compliance with~     patients.~      In this study, a multi-center, randomized, parallel controlled trial will be conducted in 10~     hospitals in Hunan Province, China, to observe the clinical efficacy and safety of the~     Bismuth-containing quadruple therapy with Ilaprazole, Doxycycline, Furazolidone and Bismuth~     Potassium Citrate in the treatment of Hp infected duodenal ulcer. It is expected to complete~     240 effective cases, including 120 cases in the experimental group and 120 cases in the~     control group.~   "
17152|NCT03342443|"~     Purpose: This randomized, double-blind, placebo-controlled clinical trial aims to evaluate~     the therapeutic effects of thalidomide in radiotherapy-related cognitive impairment.~      Further study details as provided by Sun Yat-sen Memorial Hospital, Sun Yat-sen University /~     Yameitang.~      Primary outcome measure: cognitive improvement, which is determined by the difference value~     of ADAS-cog score before and after the treatment of memantine.~   "
17153|NCT03342430|"~     This longitudinal observational cohort followed the growth and development of non-Hispanic~     white girls from age 5 to 15 years, with a focus on the development of the controls of food~     intake.~   "
17154|NCT03342417|"~     Safety and tolerability of combination of Nivolumab and Ipilimumab will be studied in~     patients with 3 different types of cancers in 3 parts of the study, as shown below:~      Part 1 - Neoadjuvant Therapy of Breast Cancer;~      Part 2 - Therapy of Ovarian Cancer; and~      Part 3 - Therapy of Gastric Cancer.~   "
17155|NCT03342404|"~     This is a Phase 2, double-blind, randomized, placebo-controlled, multicenter study to~     determine the efficacy and safety of luspatercept (ACE-536) versus placebo in adults with~     non-transfusion dependent beta (β)-thalassemia. The study is divided into the Screening~     Period, Double-blind Treatment Period (DBTP) and Post-Treatment Follow-up Period (PTFP).~      It is planned to randomize approximately 150 subjects at a 2:1 ratio of luspatercept versus~     placebo.~   "
17156|NCT03342391|"~     The purpose of this study is to test the effectiveness of utilizing Transnasal Esophagoscopy~     as a means of monitoring Eosinophilic Esophagitis patients.~   "
17157|NCT03342378|"~     This proposal explores the novel hypothesis that the variability in outcomes within the~     Intermediate Risk(IR) HPV-positive Oropharynx Squamous Cell Carcinoma(OPSCC) cohort can be~     exploited to identify a subpopulation that exhibits outcomes similar to Low Risk (LR)~     HPV-positive Oropharynx Squamous Cell Carcinoma and therefore would be appropriate candidates~     for radiation dose de-escalation approaches. Current literature using PET, CT, and MRI as~     single imaging modalities have identified certain criteria within heterogenous patient~     populations that are associated with clinical outcomes. Here, the investigators will test the~     hypothesis that multiparametric analysis of simultaneously-acquired MRI and PET quantitative~     imaging biomarker data from the primary tumor prior to initiating therapy, after 2 weeks of~     chemoradiation(CRT), and 3 months following completion of chemoradiation in patients with~     Intermediate Risk HPV-positive Oropharynx Squamous Cell Carcinoma will generate parametric~     maps that are predictive of clinical outcome.~   "
17158|NCT03342365|"~     This pilot study aims to study intestinal bacterial and fungal translocation and the~     evolution of the intestinal microbiota in patients over the course of their medical~     surveillance to search for a link between dysbiosis and bacterial/fungal translocation, but~     also to better understand the elements involved in febrile episodes in these patients (lack~     of detection of blood microorganisms, translocation of constituent elements of these~     microorganisms, etc.). We hypothesize that the composition of the intestinal microbiota as~     well as the phenomenon of intestinal microbial translocation will have an influence on the~     occurrence of fever and/or bacteremia in neutropenic patients hospitalized in pediatric~     onco-hematology.~   "
17159|NCT03342352|"~     The purpose of this study is to evaluate the safety and efficacy of the combination of~     nivolumab plus epacadostat in combination with chemotherapy in first-line recurrent or~     metastatic patients with squamous cell carcinoma of the head and neck (SCCHN) when compared~     to the standard of care (EXTREME regimen).~   "
17160|NCT03342339|"~     Parkinson's disease mainly affects the dopaminergic neurons of the Substancia nigra, which~     project on the striatum. Neuronal death within this structure leads to a decrease in dopamine~     levels. Dopamine is a neurotransmitter essential to the proper functioning of the basal~     ganglia highly involved in the control of voluntary and involuntary movements.~      It also leads to cognitive and behavioral changes. Among these changes, the investigators~     will mainly remember the idea of the emergence of difficulties to make the right decisions,~     for example at the financial, medical .... This disruption would be the result of executive~     dysfunction. By definition, executive functions allow us to evaluate, plan and organize our~     actions to achieve a goal.~   "
17161|NCT03342326|"~     While verbal memory is quickly reached in the wake of Alzheimer's disease, the musical memory~     remains preserved until a late stage of the disease. This observation encouraged the~     development of music-based therapies in the management of neurocognitive and behavioral~     disorders that characterize Alzheimer's disease. In order to develop rehabilitation programs~     that effectively target cognitive functions to stimulate, it is necessary to understand the~     mechanisms underlying this beneficial effect of music on cognition.~   "
17202|NCT03341793|"~     Bariatric surgery is recognized as a therapeutic modality of type 2 diabetes. The mechanisms~     of this remission of diabetes remain poorly understood.~      The aim of our research is to characterize the changes in muscle secretome induced by~     bariatric surgery and to determine their role in improving the insulin sensitivity of~     skeletal muscle and insulin secretion by the B cell responsible for the remission of~     diabetes.~   "
17165|NCT03342274|"~     This study will examine whether an adapted version of ]he Diabetes Prevention Program (DPP)~     can be effective when delivered by community health workers (CHWs) in a poor urban community~     in South Africa. We will randomize existing groups that are part of an non-governmental~     organization's (NGO) chronic disease management program (anticipated cluster N = 54;~     anticipated individual N=540), to receive either the program or usual care (wait-list). The~     primary outcome analysis will compare percentage of baseline weight loss at Y1 between the~     program and usual care; however, after Y1 usual care participants will also receive the~     program and both groups will be followed for another year.~   "
17166|NCT03342261|"~     Mixed cryoglobulinemia (MC) is common in patients with chronic hepatitis C virus (HCV)~     infection. Direct-acting antiviral (DAA) regimens are today very effective with sustained~     virological response rates (SVR12) above 90%. The objective of this study was to investigate~     the impact of DAA therapy on cryoglobulin clearance in patients with HCV-associated MC.~   "
17167|NCT03342248|"~     Severe mental illnesses have a significant social cost, as much by their impact on the sick~     as on their entourage. The Deinstitutionalization and care in the community of patients with~     severe mental illness result in increased families and loved ones (also known as informal~     caregivers or informal caregivers) If psychoeducation programs have been developed to help~     caregivers better manage and cope with the illness of the person being helped (optimize the~     quality of care, manage anxiety and isolation, these initiatives appear minimal in view of~     the magnitude of the burden (notion of burden: burden) and the suffering of caregivers.~     Quality of life levels remain extremely low compared to the general population, nearly 4 out~     of 10 caregivers show a sense of inability to cope with the permanent anxiety of this load,~     1/3 feels depressed and over 1/10 feels isolated on a personal and professional level~   "
17168|NCT03342235|"~     Study Objectives To compare the efficacy and safety of surgical treatment (PRK) versus~     non-surgical treatment of anisometropic amblyopia in children who have failed conventional~     treatment due to non-compliance or non-response.~      Synopsis of Study Design~      The study consists of two phases:~        1. A Patching Run-In Phase during which all participants are treated for at least 8 weeks~          with continued refractive correction (with spectacles and/or contact lenses) and~          patching prescribed 42 hours per week (averaging 6 hours daily) until no further~          improvement over 2 consecutive visits at least 4 weeks apart or the vision no longer~          meets eligibility criteria.~        2. A Randomized Trial Phase, beginning after no further VA improvement in the patching~          run-in phase and qualifying amblyopia is still present, during which the participant is~          assigned to either surgery with PRK and patching prescribed 2 hours per day or to~          non-surgical treatment with continued refractive correction (with spectacles and/or~          contact lenses) and patching prescribed 2 hours per day.~   "
17169|NCT03342222|"~     Anterior cruciate ligament (ACL) rupture is one of the most common injuries in sports~     medicine. ACL reconstructions are usually performed to restore the stability of knee joint~     and prevent the secondary meniscal and chondral lesions.~      120 Subjects with ACL injury were randomly assigned to two groups for ACL~     reconstruction.Group one: tibial fixation with PEEK Interference Screws (Rejoin Hangzhou~     Martins Medical Equipment Co., Ltd.);Group two: tibial fixation with Biosure PK interference~     screw (Smith & Nephew plc). The subjects will be followed by 12 months after surgery for~     evaluations.Outcome measures included Lysholm score,IKDC, ADT,Lachman.~   "
17170|NCT03342209|"~     determination of the half-life of COHb in CO-poisoned patients with high flow nasal oxygen~     therapy in the ED.~   "
17171|NCT03342196|"~     In the United States, thiotepa has been utilized in reduced intensity conditioning regimens~     for alternative donor courses (double umbilical cord blood transplant (dUCBT) and~     haplo-identical transplants).~      The hypothesis is that thiotepa at a dose of 10mg/kg, in combination with melphalan~     (100mg/m2) and fludarabine (160mg/m2) as a reduced intensity conditioning regimen for~     alternative donor transplant is safe and effective in patients with hematologic malignancies.~      Given that this regimen has been investigated extensively, and the current study proposes to~     confirm those previous observations with a small modification (melphalan dose reduction due~     to previous mucositis rates with higher doses), this will be a phase II study designed to~     measure disease-free-survival.~   "
17172|NCT03342183|"~     Patients who receive dialysis for kidney failure suffer severe cognitive impairment.~     Hemodialysis causes circulatory stress and ischemia, which causes severe brain injury. It has~     been demonstrated that a procedure known as Remote Ischemic Preconditioning(RIPC), which~     involves wrapping a blood pressure cuff around a patient's leg and inflating has the~     potential of protecting many organs, such as the heart from the effects of dialysis. Our~     study aims to investigate this phenomenon to determine the extent to which it provides~     protection to a dialysis patient's brain.~   "
17173|NCT03342170|"~     The non-O blood group is a risk factor of deep vein thrombosis and recurrence of~     thromboembolic events, especially when associated with Factor 5 Leiden or prothrombin G20210A~     mutations. A recent study suggests that non-O blood group may promote portal vein thrombosis~     in non cirrhotic patients.~      In addition, in general population and chronic hepatitis C, non-O blood group combined with~     one or the other of the above genetic abnormalities is associated with an increased risk of~     liver fibrosis and accelerated fibrogenesis. The suspected mechanism could be an increased~     procoagulant factor VIII and an increased Willebrand plasma level, due to a low ADAMTS 13~     activity, the result of which is an hypercoagulable state and a microthrombotic process.~      In cirrhotic patients procoagulant factors and ADAMTS 13 which are respectively increased and~     decreased, have be shown to be prognostic markers of hepatocellular function and portal~     hypertension. It has been hypothesized that the hypercoagulable state and the microthrombotic~     process could contribute to the worsening of the disease and enoxaparin has been shown to~     positively modify the prognosis of cirrhosis.~      The role of non-O blood group in decompensation of cirrhosis and occurrence of complications~     including non-tumor portal vein thrombosis has never been studied. The investigators plan a~     longitudinal observational study to determine the incidence of complications in alcoholic and~     viral cirrhosis in case of non-O blood group compared to O blood group. The aim of this study~     is to determine whether ABO blood group may promote complications in alcoholic or viral~     cirrhosis. This is an ancillary study of two national cohorts assessing natural history and~     hepatocellular carcinoma risk factors in alcoholic (CIRRAL) and viral (CIRVIR) cirrhosis.~   "
17174|NCT03342157|"~     The aim of the study is to evaluate the efficacy of the stimulant laxative Senokot-S® for the~     treatment of diabetic gastroparesis. Senokot-S, and its metabolites, are thought to produce~     peristalsis, drive intraluminal fluid and electrolyte shifts, and have an irritant effect on~     the gut mucosa. These complex physiologic mechanisms appear may sufficiently promote stomach~     emp-tying, and thereby reduce or eliminate the severity of gastroparesis symptoms. In this~     open label study, participants will be randomized into high and low dose groups to assess for~     ideal dosing and tolerability. It is the overall goal of this study to select the most~     promising dose-strength for the treatment of mild through severe gastroparesis.~   "
17175|NCT03342144|"~     An observational study to assess the effectiveness, health economic‐relevant costs and~     patient reported outcomes in patients with Chronic lymphocytic leukemia (CLL) receiving~     venetoclax as prescribed at the discretion of the physician and in accordance with local~     clinical practice and label.~   "
17176|NCT03342131|"~     This study aims to find the change of serum wnt effectory moleculars and the association with~     Hs-CRP，cTnI and Prognosis in Patients with Acute Coronary Syndrome.~   "
17177|NCT03342118|"~     Gastric peristalsis, which occurs during the endoscopic procedure, limits the visual~     inspection of the inspection field, causing interference in the inspection. The actual~     endoscopic examination is most commonly used by injecting Hyoscine butylbromide(Buscopan®),~     Cimetropium bromide (Algiron ®) into intravenous or muscular injection so it is not suitable~     for patients who undergo non-sedative esophagogastroduodenoscopy. In addition, these drugs~     were reported the side effects including thirst, dysuria, transient visual filed defect,~     tachycardia, anxiety so were not recommended for benign prostate hyperplasia, glaucoma, old~     age patients. For comfort and succesfull test, anti-spasmodics which don't have~     anti-cholinergic effect and are possible to take orally is necessary. Phloroglucin(Flospan®)~     is a smooth muscle relaxant that is currently used in the anti-spasmodic treatment without~     anticholinergic action so it can be administered in patients with glaucoma or BPH. Also it is~     suitable for endoscopic premedication due to transparent liquid component. Therefore, in this~     study, we would like to confirm the efficacy and safety of Phloroglucin (Flospan ®), which~     can be taken orally, as an pre-medication for non-sedative endoscopy.~   "
17178|NCT03342105|"~     The purpose of this study is verify the efficacy and safety of Cettum (Electrical~     moxibustion) for patients with perennial allergic rhinitis.~   "
17179|NCT03342092|"~     This study aims to assess different methods for early adiposity rebound determination at the~     age of 4/5 years old according to current medical screening criteria in schools, and to~     assess their prognostic value for obesity amongst 11 years old pre-adolescents according to~     the known risk factors.~   "
17180|NCT03342079|"~     Venipuncture (puncturing of a vein) through the skin in order to insert a vein catheter (also~     know as cannula) is one of the most common needle-related medical procedures performed in~     children. Venipuncture is necessary for administration of sedation to facilitate motionless~     patient state for radiological imaging studies such as diagnostic nuclear medicine imaging or~     CT scan studies.~      The current practice for management of needle-related pain is to use needle-less topical~     local anesthetic delivery systems. These delivery systems are increasingly used in children~     to anesthetize the skin prior to venipuncture and venous cannulae insertion. This can reduce~     the pain and distress associated with the needle sticks, however, many children express~     considerable fear, anxiety and distress during medical procedures that involve needles.~     Anticipatory pain and phobia associated with needle stick may render the patient~     uncooperative and anxious even when effective analgesia is produced by a topical local~     anesthetic.~      Both the discomfort and associated anxiety during such an intervention can be considerably~     improved when inhaled nitrous oxide is used alone or in combination with local anesthetics.~     The administration of nitrous oxide (50% to 70%) for painful procedures is an effective and~     safe method of suppressing procedural pain and distress in children over the age of one year~     (level 3 evidence). When compared to other intravenous sedation agents, nitrous oxide 50%~     used for uncomplicated painful procedures is associated with markedly shorter recovery time~     and less respiratory side effects (level 3 evidence). When combined with local anesthetics~     for procedural pain and stress management, nitrous oxide 50% is more effective and has higher~     success rate compared to orally administered anxiolytics or local anesthetic alone (level 2~     evidence). Combining nitrous oxide (50-70%) and local anesthetics is shown to be a more~     effective procedural sedation than local anesthetics alone (level 1 evidence).~      The efficacy and safety of inhaled 50-70% nitrous oxide for relief of mild-to-moderate~     anxiety and pain of venipuncture in children just prior to induction of anesthesia have been~     investigated in randomized controlled trials by anesthesiologists; physician who are skilled~     and competent in providing optimal sedation in the operating room setting. The major benefit~     of administration of a fixed low concentration of 50% nitrous oxide for procedural sedation~     is that it achieves pain relief while retaining verbal contact with the patient. The~     efficacy, safety and tolerability of administration of low fixed concentration 50% nitrous~     oxide using a nitrous oxide mask delivery system for control of mild-to-moderate procedural~     sedation during performance of needle-related pain (i.e., venipuncture) in children has not~     been investigated in a blinded randomized controlled trials outside the operating room~     setting when provided by skilled and competent non-anesthesia trained personnel.~      In view of safety of low concentration (50%) of nitrous oxide due to preservation of the~     patent airway, lack of respiratory depression and rapid recovery, investigators propose this~     preliminary study to validate the hypothesis that nurse-administered premixed inhaled nitrous~     oxide and oxygen at a fixed 50:50% concentration with or without a topical anesthetic can~     provide safe and effective pain relief and reduce behavioral distress in preschool children~     during routine placement of intravenous cannulation prior to administration of intravenous~     sedation for nuclear medicine studies and CT imaging studies.~      To test this hypothesis, investigators propose performing a prospective, double blind control~     trial in 105 children undergoing nuclear medicine studies or CT imaging, randomized into~     three groups;~        1. the treatment groups will receive either nitrous oxide and a placebo topical anesthetic~          patch or~        2. nitrous oxide and a topical anesthetic patch (Synera) and~        3. the placebo group will receive oxygen mask and a topical anesthetic patch (Synera).~      The topical anesthetic patch or placebo patch will be applied for 20 minutes prior to the~     scheduled insertion of intravenous cannula. The use of a topical local anesthetic such as the~     Synera patch is a standard of care for placement of intravenous cannula at Children's~     Hospital Boston.~      Assessments to estimate the effectiveness of nitrous oxide with and without the use of~     topical anesthesia Synera patch will include;~        1. Assessment of child's pain and observer report of pain control.~        2. Child's anxiety before and during the procedure.~        3. Tolerability of the mask delivery system of a fixed concentration of 50% nitrous oxide~          outside the operating room.~        4. Accuracy of nitrous oxide delivery dose by measuring the end-tidal concentration of~          nitrous oxide.~        5. Adverse events related to use of nitrous oxide alone or in combination with a topical~          analgesic.~   "
17181|NCT03342066|"~     Reproducibility of Interactive Cariogram Software versus Manual Caries Risk Assessment Form~     on Clinician Decision: observational study~   "
17182|NCT03342053|"~     This study will test the safety, tolerability, pharmacokinetics and pharmacodynamics of~     IONIS-HTTRx administered intrathecally to adult patients with Huntington's Disease.~   "
17183|NCT03342040|"~     The current study aims to determine if transverse abdominis plane block using local~     anesthetic agents (bupivacaine 0.25% + Ropivacaine 0.20%) decreases the post operative pain~     and helps in early mobilization or discharge from hospital in patients undergoing~     laparoscopic ventral hernia repair.~   "
17184|NCT03342027|"~     The proposed study will use a factorial design to evaluate the most promising and accessible~     behavioral and pharmacologic treatments aimed at achieving maximal efficacy for smoking~     cessation among people living with HIV who smoke. The study will randomize 300 participants~     people living with HIV , who smoke and who are receiving care in a methadone maintenance~     program in Nairobi, Kenya to one of the following 4 conditions: (1) bupropion + Positively~     Smoke Free (an 8 session tailored behavioral intervention for people living with HIV~     smokers); (2) bupropion + Standard of Care (brief advice to quit); (3) Placebo + Positively~     Smoke Free; and (4) Placebo + Standard of Care.~   "
17185|NCT03342014|"~     Introduction: Preeclampsia (PE) and intrauterine growth restriction (IUGR) are two major~     pregnancy complications, related to a chronic utero-placental hypoperfusion. Nowadays, there~     isn't a screening or diagnostic test in clinic for utero-placental vascularization~     deficiency. Since 2004, 3D Power Doppler angiography has been used for the evaluation of~     utero-placental vascularisation and three vascular indices have been calculated: the~     vascularisation index (VI), flow index (FI) and vascularisation-FI (VFI). A high intra and~     inter-observer reproducibility and its potential interest for placental function study were~     reported. The investigator's main hypothesis is that these 3DPD indices could provide~     predictive values for PE and/or IUGR occurrence much higher than those observed with the~     currents other markers.~      Objectives: The main objective of this study is to determine differences in 3DPD indices at~     first trimester between pregnancies defined at their outcome as uncomplicated pregnancy, PE~     (mild and severe) and IUGR in nulliparous women.~      Methods and analysis: This is a prospective study. The investigators expect to include 2200~     women in 3 French centers: CHRU of Nancy, Paris-APHP Port-Royal, and Strasbourg.~      The nulliparous pregnant women will be recruited during their 1st trimester consultation for~     routine Down syndrome screening (11-13+6 GW). Especially for the study, the 3DPD and Uterine~     Artery Doppler (UAD) acquisition, which last less than 10 min, will be included in the~     current routine 11-13+6 GW ultrasound screening for Down syndrome. Also, additional blood~     samples will be taken for biomarker analysis (PAPP-A and P1GF) and biological collection.~     Utero-placental vascularization indices (VI, FI, VFI) will be quantified using VOCAL®~     software. For each subgroup (uncomplicated pregnancy, PE and IUGR) mean values in 3DPD~     indices will be computed and compared using a pairwise t test with a Bonferroni correction p~     value adjustment.~   "
17186|NCT03342001|"~     Some people with hypothyroidism have persistent symptoms despite adequate treatment with~     thyroid hormones. We are testing whether giving calcitonin to such people will improve their~     quality of life.~   "
17187|NCT03341988|"~     1. To asses curability of( Ombitasvir ,Paritaprevir,Ritonavir) in chronic HCV infected~          patients in those with CKD versus ESRD in Assiut Hospital University .~        2. Also assess duration of sustained viral response,treatment, relapse or failure of~          therapy in CKD versus ESRD in Assiut Hospital.~   "
17188|NCT03341975|"~     This is an adaptive trial with an initial Formative Revision Process followed by a Randomized~     Controlled Trial (RCT). Up to 500 adolescents will be consented into this study to achieve 6~     completed subjects for the formative process and 116 completed subjects (58 in each arm) for~     the RCT.~   "
17189|NCT03341962|"~     This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding~     study to evaluate the efficacy and safety of IMU-838 for induction and maintenance therapy in~     moderate-to-severe ulcerative colitis (CALDOSE-1).~   "
17190|NCT03341949|"~     Chronic renal disease (CKD) is defined as a decrease in glomerular filtration rate (GFR) and~     / or proteinuria or albuminuria (a protein present in urine). Albuminuria is considered a~     marker of endothelial dysfunction. Proteinuria and / or albuminuria are recognized as~     cardiovascular risk factors in both diabetic and non-diabetic populations, independently of~     GFR. It is also a marker of progression of kidney disease. cluster of differentiation 146~     (CD146) is an endothelial adhesion molecule with preferential localization in the junction.~     Soluble CD146 (or CD146s). CD146s is a biomarker of endothelial dysfunction that is easy to~     assay. The increase in CD146 levels was described during the MRC, especially in diabetic~     patients with significant proteinuria. In two independent cohorts of patients with CDR,~     CD146s did not correlate with creatinine or GFR but appeared to correlate with proteinuria.~      The aim of our study is to determine whether the blood concentration of CD146s is correlated~     with proteinuria independently of GFR. For this purpose, we propose this study in the kidney~     nephrology and transplantation center of Conception Hospital, with the objective of~     highlighting the link between proteinuria and serum CD146 levels in patients with CKD,~     whatever their renal function and / or underlying pathology. 205 patients will be included~     over two years with dosing of CD146s and proteinuria at the same time. These 205 patients~     will be recruited at each stage of the CKD (41 in each arm). CD146s could be a new biomarker~     predicting the risk of renal function impairment or cardiovascular risk independent of renal~     function.~   "
17191|NCT03341936|"~     This research study is studying a combination of two immunotherapy drugs, as a possible~     treatment for locoregionally recurrent squamous cell carcinoma of the head and neck.~      The immunotherapy drugs involved in this study are:~        -  Nivolumab (Opdivo™)~        -  Lirilumab~   "
17192|NCT03341923|"~     The purpose of this clinical study is to evaluate DAILIES TOTAL1® Multifocal (DT1MF) contact~     lenses compared to 1-DAY ACUVUE® Moist® Multifocal (AMMF) contact lenses for~     investigator-graded lens centration in a Japanese population.~   "
17193|NCT03341910|"~     A study for Subjects with mild to moderate facial acne vulgaris. Subjects will be randomized~     to treatment with either DFD-03 (tazarotene) Lotion 0.1%, Tazorac (tazarotene) Cream, 0.1%,~     Vehicle Lotion or Vehicle Cream. During the 12-week treatment period subjects randomized to~     DFD-03 Lotion or Vehicle Lotion will use the study drug twice daily. Subjects randomized to~     Tazorac Cream or Vehicle Cream will use the study drug once daily in the evening. Subjects~     will be instructed to treat the entire face.~      Safety assessments will include the investigator's assessment of local cutaneous~     tolerance/application site reactions on the face, vital signs and adverse events. Urine~     pregnancy tests will be performed for all female subjects. A physical examination will be~     performed.~   "
17194|NCT03341897|"~     A varicocele is a collection of varicose veins within the pampiniform (spermatic) plexus~     secondary to reflux in the internal spermatic vein (ISV).The condition affects 10% to 15% of~     the general population but is detected in as many as 40% of men undergoing an infertility~     workup. Depending on the method used for diagnosis, varicoceles are reported as bilateral in~     17% to 77% of men. Traditionally, the diagnosis was made through clinical examination;~     however,as with other venous reflux disorders, ultrasound has become the mainstay of~     diagnosis. The traditional indications for treatment include infertility in patients with~     appropriate semen abnormalities, chronic groin pain, testicular atrophy in adolescent~     varicoceles, and recurrent varicocele after previous repair. Other indications more recently~     described with variable strength of evidence include low serum testosterone (with or without~     erectile dysfunction), benign prostatic hypertrophy,enhancement of assisted fertility~     techniques, and recurrent first trimester pregnancy loss.Infertility affects 10% to 15% of~     men of reproductive age. In approximately 50%, a cause is not found. The proof that~     varicocele repair improves fertility remains elusive; however, there is general acceptance~     that treatment does improve abnormalities of semen production.The traditional measures to~     assess semen production are sperm motility,morphology, and total sperm count. However, sperm~     counts greatly vary from day to day in any individual patient, and these measures correlate~     poorly with infertility outcomes.~      The investigators do this study to evaluate the effectiveness of endovascular therapy using~     coils and other sclerosing agents and compare their results with other traditonal surgical~     methods in treatement of varicocele.~   "
17195|NCT03341884|"~     This is a Phase 1 study evaluating the pharmacokinetics, tolerability and safety of a single~     dose of ipatasertib in participants with mild, moderate or severe hepatic impairment compared~     to healthy participants.~   "
17196|NCT03341871|"~     This multi-center, post-marketing, observational study evaluates the real world safety and~     effectiveness of glecaprevir plus pibrentasvir use in participants infected with the~     hepatitis C virus genotype 1 - 6.~   "
17197|NCT03341858|"~     STRONG Kids 2: A Cells to Society Approach to Nutrition~      Overview Using a cells-to-society approach to nutrition, this transdisciplinary project will~     provide unique insights into how individual biology interacts with the family environment to~     promote healthy eating habits in young children. It is one of the first studies to take a~     longitudinal look at the habits, including milk and dairy consumption, from birth. STRONG~     Kids 2 is built upon previous research from STRONG Kids 1 with preschool-aged children,~     documenting the relationship among genetic, child, and family factors in predicting BMI and~     dietary habits. The study sample includes 450 infants and their families located in small~     urban communities in central Illinois. Biological samples and height and weight measurements~     from infants and toddlers are collected at 6 weeks, 3, 12, 18, 24, and 36 months, 4 and 5~     years. Mothers are surveyed about weaning, dietary habits, household routines, children's~     emotions, feeding styles, and milk and dairy consumption. Additional measures such as~     maternal height and weight are also being collected.~   "
17198|NCT03341845|"~     a monocenter, open label, single arm, phase II study of the combination of axitinib with~     avelumab as neoadjuvant therapy in patients with intermediate to high-risk non-metastatic~     RCC.~   "
17199|NCT03341832|"~     The purpose of this study is to evaluate the efficacy and safety NVP-1203 in patients with~     Acute low back pain~   "
17200|NCT03341819|"~     The purpose of this study is to compare the prevalence of postoperative urinary retention~     between retained and non-retained urinary catheter in total knee arthorplasty with epidural~     anesthesia~   "
17201|NCT03341806|"~     The purpose of the study is to characterize the safety and tolerability of avelumab in~     combination with Laser Interstitial Thermal Therapy (LITT) for blood barrier disruption in~     patients with recurrent glioblastoma.~   "
17207|NCT03341728|"~     The aging population is at an exceptionally high risk of debilitating falls, contributing~     significantly to reduced independence and quality of life. It remains extremely challenging~     to screen for falls risk, and programs designed to mitigate falls risk have only modestly~     influenced the sizeable portion of the aging population experiencing one or more falls~     annually. Balance control in standing and walking depends on integrating reliable sensory~     feedback and on planning and executing appropriate motor responses. Walking balance control~     is especially dynamic, requiring active and coordinated adjustments in posture (i.e., trunk~     stabilization) and foot placement from step to step. Accordingly, using a custom, immersive~     virtual environment, the investigators have shown that sensory (i.e., optical flow)~     perturbations, especially when applied during walking, elicit strong and persistent motor~     responses to preserve balance. Exciting pilot data suggest that these motor responses are~     remarkably more prevalent in old age, presumably governed by an increased reliance on vision~     for balance control. Additional pilot data suggest that prolonged exposure to these~     perturbations may effectively condition successful balance control strategies. Founded on~     these recent discoveries, and leveraging the increase reliance on vision for balance control~     in old age, the investigators stand at the forefront of a potentially transformative new~     approach for more effectively identifying and mitigating age-related falls risk. The~     investigator's overarching hypothesis is that optical flow perturbations, particularly when~     applied during walking, can effectively identify balance deficits due to aging and falls~     history and can subsequently condition the neuromechanics of successful balance control via~     training.~   "
17208|NCT03341715|"~     The purpose of this pilot study is to evaluate the role of Mavoglurant in clarifying the~     neurobiology of alcoholism risk. This is a 1-site, randomized, within subjects,~     counterbalanced double-blind study of a single dose (200mg) of Mavoglurant and placebo.~   "
17209|NCT03341702|"~     Prison concentrates people with violent behavior and patients suffering from psychiatric~     disorders. Aggression are daily, the suicide rate is 5 to 10 times higher than the ordinary~     environment and current prevention devices have shown their limits.~      That's why, in order to improve the violence's prevention in prison, the investigator propose~     to identify the predictive factors of violence by studying retrospectively the link between~     the psychiatric profile and commission of violence after being jailed.~   "
17210|NCT03341689|"~     The purpose of this study is to investigate the effects of oral psilocybin in migraine~     headache. Subjects will each receive a dose of placebo and a dose of psilocybin approximately~     14 days apart. Subjects will be randomized to the order of treatment and they will be~     randomized to receive either low or high dose psilocybin. Subjects will maintain a headache~     diary prior to, during, and after the treatments in order to document headache frequency and~     intensity, as well as associated symptoms, in both the short and long-term.~   "
17211|NCT03341676|"~     When the brain detects a drop in oxygen levels in the blood (hypoxia) there is a compensatory~     increase in blood flow. Acute mountain sickness (AMS) is a cluster of symptoms which commonly~     occur in those ascending to high altitude and experiencing hypoxia due to increased blood~     flow and then swelling in the brain. Symptoms include headache, nausea, insomnia and fatigue.~     The exact mechanisms by which AMS develops remains poorly understood. Dexamethasone has been~     shown to reduce the risk of developing significant brain swelling in other settings.~     Therefore we hypothesise that administering low dose Dexamethasone could protect against~     hypoxia induced cerebral and spinal oedema.~   "
17212|NCT03341663|"~     Investigators adopt cross-sectional study design to carry out the exemplary research in the~     aspects of disease diagnosis.This study is designed to confirm the hypothesis acupoint~     sensitization is associated with a severity of angina pectoris, which may contribute to the~     diagnosis of stable angina pectoris. After the eligible participants recruited in group, the~     coronary artery lesions will be evaluated through coronary angiography and the Canadian~     Cardiovascular Society(CCS) angina pectoris classification will also be evaluated at the same~     time. The degree of acupoint sensitization will be tested by the electronic Von Frey~     instrument by one professional acupuncturist with total 12 acupoints, including~     Shenmen,Yinxi, Shaohao,Jiquan,Neiguan, Ximen, Quze, Shanzhong, Juque, Jueyinyu, Xinyu, Duyu.~     Analysis were conducted to explore relationships between the degree of acupoint~     sensitization, the degree of coronary artery stenosis and CCS angina pectoris classification.~     Diagnostic value will be further analyzed in the final step.~   "
17213|NCT03341650|"~     To the best of our knowledge, the effect of pasta consumption within a hypocaloric~     Mediterranean diet has only been scarcely explored yet. Therefore, a two-parallel group~     dietary intervention was carried out to investigate if pasta consumption could affect the BMI~     change in obese patients. The primary outcome was the loss of at leat 8% of the initial body~     weight in the first 6 months. Anthropometric and body composition (from bioelectrical~     impedance analysis - BIA-) measures were collected every month for the first 6 months and~     after 1 year. In addition, dietary information was collected at baseline and after 3, 6 and~     12 months through a 7-day carbohydrate food record and a 24-h food recall. Blood samples were~     collected at baseline and at 6 and 12 months to assess: glucose, insulin, Homeostatic model~     assessment for insulin resistant (HOMA-IR) index, total cholesterol, low-density lipoprotein,~     high-density lipoprotein, and uric acid. Furthermore, the perceived quality of life was~     investigated through the 36-items short form health survey (SF36) questionnaire.~   "
17214|NCT03341637|"~     The purpose of this study is to describe the neutralizing antibody response against each~     dengue serotype at 1 month post second dose of TDV or placebo in dengue-naive adolescent~     participants.~   "
17215|NCT03341624|"~     To observe the clinical characteristics and surgical treatment of 24 cases of congenital~     cataract complicated with Persistent Fetal Vasculature (PFV) in 28 cases of congenital~     cataract in our hospital.~   "
17216|NCT03341611|"~     The investigators propose to study the effect of aging on the neural circuitry involved in~     valuation and value reasoning and to relate it to choice anomalies and inconsistencies.~     Quantifying and characterizing valuation-based decision-making deficits in older adults, and~     their relationship to the aging brain, can inform and facilitate intervention - both at the~     level of the individual and at the level of policy.~   "
17217|NCT03341598|"~     The aim of the present study is to compare the use of the xenogeneic graft (MC) plus coronary~     advanced flap (CAF) and the coronary advanced flap alone, both associated with the partial~     restoration of composite resin in the treatment of gingival recessions associated with~     non-carious cervical lesion.~   "
17218|NCT03341585|"~     The purpose of this study is to determine whether a specific airway clearance technique,~     l'Expiration Lente Prolongée (ELPr), induces or aggravates gastro-oesophageal reflux in~     infants under the age of one year. Infants referred to hospital for a multichannel~     intraluminal impedance pH (pH-MII) monitoring are included in this study. Participation is~     only possible after signing the informal consent by one of the parents.~   "
17219|NCT03341572|"~     To observe the effect of PEEP on CVP among patients with different respiratory compliance~   "
17220|NCT03341559|"~     This study is designed to evaluate the ability of Spatial Frequency Domain Imaging (SFDI) to~     measure perfusion in lower extremities for prediction of both healing and formation of~     diabetic foot ulcers.~      The investigators will perform longitudinal imaging (for 12 months) in two cohorts of~     subjects~   "
17221|NCT03341546|"~     A computational model has been created to estimate the abdominal depth of a patient from a~     single x-ray image. The model has been tested using phantoms and found to be accurate; this~     study aims to test the accuracy of the model with patients and in a clinical setting.~      This will be achieved by enrolling patient's who have already been referred for an~     anterior-posterior abdomen x-ray examination to the trial, taking a physical measurement of~     their anterior-posterior abdominal depth and then comparing this measured value with a value~     as estimated using the computational model based on the patient's x-ray image.~   "
17222|NCT03341533|"~     The purpose of this study is to evaluate the effect of using ice packs on the abdomen~     immediately after laparoscopic hysterectomy surgery on pain control and narcotic pain~     medication use.~   "
17223|NCT03341520|"~     Combined modality approach using Obitunuzumab and involved site low dose irradiation in early~     stage nodal follicular lymphoma. Radiation dose will be adapted for low-responders.~      Primary Objective:~      Evaluation of the rate of metabolic CR after low-dose involved site radiotherapy in~     combination with Gazyvaro (Obinutuzumab) in early stage nodal follicular lymphoma in order to~     avoid conventional full dose IF radiotherapy.~      Secondary Objective:~      Efficacy and safety of a response adapted radiation dose treatment schedule.~   "
17224|NCT03341507|"~     This study evaluates the efficiency of the rigid tube for laryngoscopy for tracheal~     intubation in patients with presumed difficult airway and compare the classical laryngoscopy~     and this method in matter of glottis visualisation and tracheal intubation.~   "
17225|NCT03341494|"~     EGFR-TKIs are the standard first-line treatment option for EGFR-mutant NSCLC. After a~     randomized phase II trial, JO25567 was presented at 2014 ASCO, the synergistic effect of~     progression-free survival(PFS) could be expected when EGFR TKI, Gefitinib is combined with~     Antiangiogenesis agent thalidomide, Therefore Chinese data of treating EGFR mutation positive~     NSCLC patients with Gefitinib and thalidomide is significantly necessary for developing new~     standard treatment in first-line therapy in Chinese EGFR mutant NSCLC patients.~      In this study, The investigators will investigate the efficacy and safety of Gefitinib and~     thalidomide combination compare to Gefitinib alone in Chinese EGFR-mutant NSCLC patients.~   "
17226|NCT03341481|"~     Femaltiker is a food for special medical purposes with a unique composition. Because beer,~     but not ethanol, has been reported in a number of studies to stimulate prolactin levels and~     breastmilk production, polysaccharide from barley was chosen as a potential galactogogue. To~     verify our assumption, a randomized, double blinded research with placebo was performed. The~     study was conducted according to good clinical practice and 10% of output data was audited by~     the outside monitor. The research was conducted from 14 April 2014 to 7 October 2015 in two~     NICUs with consent of the ethics committee on Medical Warsaw University.~   "
17227|NCT03341468|"~     This is a randomized controlled study to determine the efficacy and safety of a patented~     urethral catheter support device designed to reduce discomfort associated with urethral~     catheter mobility in males.~      Movement of a catheter within the urethra is a source of discomfort for patients. The~     investigators hypothesize that this discomfort can be reduced by using an external device~     designed to securely fasten the catheter to the penis.~   "
17228|NCT03341455|"~     We aim to implement a community-based support program delivered by preschool teachers and~     volunteer parents that will increase awareness, knowledge and uptake of available services~     for IPV and substance misuse, and of the link between these issues and poorer education~     outcomes in children. Through this, we aim to decrease the prevalence of IPV and substance~     misuse.~      The proposed method of implementation is to deliver targeted training to preschool teachers,~     mothers with children at the preschools, fathers with children at the preschools, and~     community development officers managing preschools. This project will target the most~     vulnerable sections of the community and will provide a sustainable and feasible strategy for~     scale up of the intervention.~      By intervening through these preschools the investigators aim to identify and support~     high-risk families early enough to arrest the cycle of violence that results in children~     themselves becoming victims and perpetrators of such violence.~   "
17229|NCT03341442|"~     The purpose of this study is to perform a randomized controlled study to compare patients~     undergoing THA via a posterolateral approach to receive either standard of care post-surgery~     hip restrictions or to receive no restrictions. The investigators goal is to first complete a~     pilot study in which the investigators assess the short term dislocation rates 3-6 months and~     then continue to recruit into this study and follow these patients for a year to determine~     the 1 year risk for dislocation. The investigators also will compare the HOOS Jr. and VAS~     scores and time until free from walking aid. The research question is: Will the elimination~     of post operative posterior hip precautions increase the dislocation rate? The hypothesis is~     that the elimination of post operative hip precautions will not increase the dislocation~     rate.~   "
17230|NCT03341429|"~     A double-blinded, randomised, placebo-controlled trial of liraglutide 3.0 mg in patients with~     poor weight-loss and a suboptimal glucagon-like peptide-1 response following bariatric~     surgery~   "
17231|NCT03341416|"~     Cerebellar ataxias are a group of disorders caused by cerebellar affections, for which~     currently no specific treatment is available. Some limited studies verified the effects of~     cerebellar transcranial magnetic stimulation (TMS) on ataxic symptoms, with good results. The~     hypothesis is that cerebellar TMS could improve ataxic symptoms in some patients and in these~     patients, chronic cerebellar stimulation through deep brain stimulation could be a~     therapeutic option. The rationale is to stimulate the dentate nucleus of the cerebellum in~     order to balance the functional asymmetry observed between both motor cortices after chronic~     cerebellar lesions.~   "
17232|NCT03341403|"~     It is a randomized double blind placebo control study. One hundred severe asthmatic patients~     will receive Probiotical ® each day during 3 months and will be evaluated before and 1-3-6~     months after in order to assess the impact of the synbiotic on the lung function, the exhaled~     nitric oxide value, the inflammatory blood and sputum profiles, the bronchial reactivity, the~     microvascular health and the quality of life and asthma control. The hypothesis is that, as~     these patients are not optimally controlled, the synbiotic could have an impact by decreasing~     the inflammation state at local and systemic level and then improve the quality of life and~     the asthma control. Indeed, synbiotic have been shown to possess beneficial effects on the~     immune system.~   "
17233|NCT03341390|"~     The purpose of this study is to investigate the effect of taking multiple doses of BMS-986177~     when aspirin is taken once-daily. Eligible participants will receive twice-daily doses of~     BMS-986177 or placebo, with a once-daily dose of aspirin. The safety, tolerability and~     movement of BMS-986177 into, through and out of the body (pharmacokinetics/PK) will be~     assessed, as will the effect of BMS-986177 on the PK of aspirin.~   "
17234|NCT03341377|"~     Investigators propose a prospective cohort study to develop and validate essential technical~     parameters for establishing the perioperative symptom management cohort in patients with lung~     cancer. With 300 patients with lung cancer who are going to have surgery, this study will~     administrate symptom assessments (MDASI-LC) on the day before surgery (within 3 days before~     surgery), daily after surgery (in hospital ≤ 14 days), and weekly after discharge, up to 4~     weeks (±3 days) or the start day of postoperative oncologic treatment.~   "
17235|NCT03341364|"~     This study evaluates the preliminary effects of an Acceptance and Commitment (ACT)-based~     group therapy compared to individual ACT-therapy for adult cancer patients suffering from~     psychological distress. Half of the participants will receive ACT in a group setting, while~     the other half will receive individual ACT.~   "
17236|NCT03341351|"~     This is a study evaluating the use of the modified beef tongue model for teaching repair of~     obstetrical fourth-degree laceration to residents. Participants will be randomized to either~     an instructional video using the modified beef tongue model or to an instructional workshop~     using the modified beef tongue model. Primary outcome will be measured as change in technical~     skills score as measured by change from baseline on a validated objective structured~     assessment of technical skills (OSTATS) for repair of fourth-degree laceration.~   "
17237|NCT03341338|"~     Anaemia continues to be one of the most common health problems affecting children and~     pregnant women in low-income countries. Nutritional iron deficiency is believed to be the~     main driver of anaemia, so mass iron supplementation and food fortification programs have~     been recommended by most public health organizations. However, these interventions are~     frequently ineffective and new strategies are desperately needed.~      Both anaemia and iron absorption are influenced by multiple factors, including nutritional~     status, infection, low grade inflammation and host genetics. The discovery of hepcidin, the~     master regulator of iron absorption and regulation has opened new avenues for investigation.~     Genome-wide association studies have identified several single nucleotide polymorphisms~     (SNPs) within hepcidin regulatory genes that are associated with altered iron status both in~     African populations.~      The study aims to investigate the impact of genetic alterations in hepcidin regulation on~     oral iron absorption. A recall-by-genotype study will be conducted using an existing database~     of pre-genotype individuals in rural Gambia (West Kiang). This database comprise of data on~     >3000 Gambians, with Illumina HumanExome array data on 80K directly genotyped putative~     functional variants as well as imputation data on 20M variants.~   "
17238|NCT03341325|"~     There is practical evidence but no scientific investigations that persons with severe~     disorders of consciousness can profit from animal-assisted therapy regarding their level of~     awareness.~      The aim of this study is to investigate the effect of animal-assisted therapy on brain~     activity of inpatients at REHAB Basel with severe disorders of consciousness.~      To do so, the frontal brain activity of 20 the inpatients at REHAB Basel in a minimally~     conscious state is investigated via near-infrared spectroscopy (NIRS). Moreover, 20 healthy~     participants are included as control subjects.~   "
17239|NCT03341312|"~     The purpose of this study is to evaluate a new formulation of insulin lispro, LY900014, which~     is a drug that lowers blood sugar. The study will look at how the body processes LY900014,~     and the effect of LY900014 on blood sugar levels following a standard meal. For each~     participant, the study will consist of 4 periods and will last approximately 12 weeks from~     screening to final study follow up.~   "
17240|NCT03341299|"~     The purpose of this study is to evaluate a new formulation of insulin lispro, LY900014, which~     is a drug that lowers blood sugar. The study will look at how the body processes LY900014,~     and the effect of LY900014 on blood sugar levels following a standard meal. For each~     participant, the study will consist of 4 periods and there will be approximately 12 weeks~     from screening to final study follow up.~   "
17241|NCT03341286|"~     The product under investigation relates to a pharmaceutical composition containing a~     pyrimidine nitrogen base, thymine, and the essential amino acid tryptophan. This product~     seems to have effect on quality of life and enhance adverse affects of chemotherapy in cancer~     patients.~   "
17242|NCT03341273|"~     This is a randomized, double-blinded, placebo-controlled, non-inferiority multicenter~     clinical trial of azithromycin vs. placebo in adults presenting as outpatients with suspect~     LRTI and a PCT level of < /=0.25 ng/mL, as a strategy for reducing antibiotic prescriptions.~     The study is designed to compare the efficacy of azithromycin versus placebo on Day 5 (i.e.,~     after 4 days of treatment) in subjects with suspect LRTI and PCT levels of < /=0.25 ng/mL at~     enrollment using a non-inferiority approach. The study will recruit potential subjects 18~     years of age or older who are suspected to have LRTI and 420 subjects will be randomized 1:1~     to receive oral azithromycin or placebo for five days. Randomized subjects will have efficacy~     measured from the time of the first dose of study drug (Day 1) through approximately Day 28.~     The Primary Objective is to compare the efficacy of azithromycin versus placebo on Day 5~     (i.e., after 4 days of treatment) in subjects with suspect LRTI and PCT levels of < /=0.25~     ng/mL at enrollment using a non-inferiority approach.~   "
17243|NCT03341260|"~     The purpose of this study is to assess the effect of preoperative a single-dose of 50 mg~     diclofenac potassium on postoperative endodontic pain in mandibular molars with symptomatic~     irreversible pulpitis.~   "
17244|NCT03341247|"~     The proposed research will follow healthy weight children who vary by family risk for obesity~     to identify the neurobiological and appetitive traits that are implicated in overeating and~     weight gain during the critical pre-adolescent period. The investigator's central hypothesis~     is that increased intake from large portions of energy dense foods is due in part to reduced~     activity in brain regions implicated in inhibitory control and decision making, combined with~     increased activity in reward processing pathways. To test this hypothesis, the investigators~     will recruit 120 healthy weight children, aged 7-8 years, at two levels of obesity risk~     (i.e., 60 high-risk and 60 low-risk) based on parent weight status.~   "
17245|NCT03341234|"~     Breast cancer is the most common type of cancer in women. Mastectomy and axillary lymph node~     disection are commonly performed as part of the cancer management. This surgery can cause~     significant postoperative pain. The serratus plane block (SPB) has been described for~     analgesia of the hemithorax and reported for many cases such as thoracoscopy, shoulder~     arthroscopy, breast surgery and axillary lymph node dissections. Serratus plane block may be~     a viable alternative to current regional anaesthetic techniques such as thoracic~     paravertebral and central neuraxial blockade.~      The aim of this study is to determine effectiveness of ultrasound guided superficial serratus~     plane block in patients undergoing modified radical mastectomy and axillary lymph node~     dissection surgery.~   "
17246|NCT03341221|"~     Ascites is the pathologic accumulation of fluid within the peritoneal cavity. Causes of~     ascites in infants and children :hepatobiliary disorders,serositis, neoplasm, cardiac,~     genitourinary disorder, metabolic disease and others.~      Diagnosis of ascites :history of abdominal distention, increasing weight, respiratory~     embarrassement, symptoms and signs of (hepatic ,cardiac,renal disease, tuberculosis and~     malignancy).~      lnvestigation:complete blood count, complete urine examination, liver function tests, plasma~     proteins, renal function tests, clotting screen, tuberculin test, chest and abdominal plain~     films,abdominal ultrasound, upper gastrointestinal endoscopy, abdominal paracentesis for~     ascitic fluid analysis .~   "
17247|NCT03341208|"~     Acute pulmonary embolism (PE) is a condition in which the vessels carrying blood to the lungs~     become suddenly blocked, usually by a blood clot. There are a number of adverse consequences~     that result, with one of the most significant being strain on the right side of the heart~     (which must push blood through the blocked arteries to the lungs). Although this strain on~     the right heart is very important, current methods for measuring it are flawed. The standard~     practice is to obtain an echocardiogram (ultrasound of the heart), from which indirect~     measurements of the size of the heart are used to make inferences about right heart strain.~     This method can help guide management in some patients, but it in not a sensitive test and~     does not provide detailed information.~      Patients with PE are treated with blood thinning medications. Some patients may be referred~     to the Interventional Radiology (IR) team for endovascular intervention, in which catheters~     are placed into the patient's vessels under radiologic guidance and advanced to the lungs to~     remove the clot entirely.~      Cardiac magnetic resonance imaging (MRI) is a well-established imaging technique that~     produces highly detailed images of the heart's structure and function, with no risks to~     patients of ionizing radiation or intravenous contrast. Cardiac MRI is far superior to~     echocardiogram in evaluation of the right side of the heart, however it has not been widely~     used in the evaluation of patients with PE. We propose that by using a fast MRI protocol, we~     will be able to detect right heart strain with more accuracy than echocardiogram.~     Furthermore, we hypothesize that MRI images obtained before and after IR catheter-directed~     therapy will demonstrate the degree to which strain is relieved with this treatment. Finally,~     we believe that using MRI may help to guide management of patients with PE by detecting early~     or mild heart strain before it progresses.~      In order to test these hypotheses, we plan to image PE patients who have been referred to the~     IR team with MRI. Patients recruited for this study will undergo two short MRI scans - one~     immediately before treatment, and one after completion of IR treatment (which lasts~     approximately 12-24 hours).~   "
17248|NCT03341195|"~     Routine childhood immunization (RCI) in Pakistan is well below the recommended coverage of~     90% with rates as low as 16% in certain regions (Pakistan DHS 2012-3). This has led to~     continued polio transmission, large measles outbreaks and thousands of deaths from~     vaccine-preventable diseases (Kazi.Bull WHO 2016). Mobile phone communication is widespread~     in developing countries and has proven a potential method of directly connecting pregnant~     women and mothers to health services (Kharbanda. Expert Review of Vaccine 2014). The~     investigators propose conducting a mixed methods proof of concept cluster randomized trial~     (CRT) to assess the effectiveness of different types of SMS messaging and automated calls to~     improve RCI and understand the perceptions and barriers that may affect SMS and automated~     call-based interventions at participants levels. the investigators will conduct the study at~     urban and rural sites in Pakistan. The investigators will examine an important public health~     question - do low cost, automated SMS, and automated messages improve RCI coverage in~     resource-constrained settings? Further, investigators will compare the effectiveness of~     reminder, educational and interactive text messages for improving RCI and will generate~     socio-cultural data regarding the impact of participants health beliefs that will be~     important for setting up the appropriate interventions in other LMICs.~   "
17249|NCT03341182|"~     Lumbar Transforaminal Epidural Injection is helpful for the treatment of lumbosacral~     radicular pain.~      Tunnel view technique is the basis of X-ray assisted intervention. In this technique, it is~     necessary to handle the block needle in order to adjust the direction of needle to the tunnel~     view toward target. If a mirror is used during needle handling, overall procedure time and~     radiation exposure can be reduced.~   "
17250|NCT03341169|"~     The purpose of this study is to confirm if myocardial protection effect can be obtained by~     intravenous administration of glutamine in patients undergoing aortic valve replacement with~     severe aortic stenosis (who are at high risk for ischemia-reperfusion injury). As a~     prospective double blinded randomized placebo-controlled trial, the investigators detect and~     compare the degree of myocardial damage(with CK-MB and Troponin T) and myocardial protection~     (through hsp 70 expression in atrial tissue), cardiovascular index, inflammatory reaction,~     and clinical manifestation.~   "
17251|NCT03341156|"~     This study is comparing the use of Kcentra vs. standard transfusion in patients undergoing~     heart transplantation surgery. Half of the patients will receive Kcentra, while the other~     half will receive fresh frozen plasma.~   "
17252|NCT03341143|"~     The main goal of this research study is to determine if the fecal microbiota transplant (FMT)~     improves the body's ability to fight your cancer.~   "
17267|NCT03340948|"~     The Mindfulness Intervention as Myocardial Infarction Rehabilitation Additive (MIMIRA) study~     aimed at studying the feasibility and acceptability of Mindfulness Based Stress Reduction -~     an 8 week course in meditation and yoga - in patients with a recent coronary artery event and~     elevated depressive symptoms. To address these questions patients with elevated scores on a~     depression scale were invited to participate in MBSR, and there evaluation of the course as~     well as a panel of psychological risk factors and resources was measured.~   "
17253|NCT03341130|"~     Obstructive sleep apnea (OSA) is a sleep related breathing disorder, affecting approximately~     10% of adults. Mandibular advancement oral appliances (OAM) are an effective treatment for~     OSA, however, long term use has shown to lead to changes in teeth positioning and jaw~     alignment (bite changes), which has resulted in some patients stopping treatment.~      It is becoming common clinical practice for doctors to prescribe the use of repositioning~     splints to help reduce the bite changes associated with using OAM. However, this has not been~     studied in a clinical trial.~      This study will compare the bite changes between patients using OAM alone against patients~     using a morning repositioning splint in addition to OAM. Other variables, such as oral~     health, the size of mandibular advancement, and treatment adherence will also be measured to~     determine if they have an effect on the bite changes associated with OAM use.~      By understanding the key the factors that influence the bite changes associated with OAM use~     and potentially validating a technique to reduce these changes, this study will improve the~     clinical practice of Dental Sleep Medicine, leading to improved health outcomes for OSA~     patients.~   "
17254|NCT03341117|"~     OBJETIVE To assess the effect of acetylsalicylic acid on antioxidant enzymatic system in~     patients with type 2 diabetes~   "
17255|NCT03341104|"~     This study aims to compare the effectiveness of liposomal bupivacaine (LB) versus standard of~     practice local injection containing plain bupivacaine.~   "
17256|NCT03341091|"~     This study evaluates the feasibility and the preliminary effects of a simplified 10-step~     Tai-chi programme (a dyadic approach) on the mobility performance of people with mild to~     moderate dementia.~      Four community health centres were recruited and each was randomised to either the~     intervention group (Tai-chi) or the control group. Tai-chi group received a 16-week 10-step~     simplified Tai-chi training programme in which additional measures were implemented to~     enhance participants' engagement. The control group took part in group recreational~     activities organized by the community centres.~      It was hypothesized that the Tai-chi group would outperform the control group regarding their~     mobility performance.~   "
17257|NCT03341078|"~     Addiction to methamphetamine is a serious health problem in the United States. Right now,~     there are no medications that a doctor can give someone to help them stop using~     methamphetamine. More research is needed to develop drugs for methamphetamine addiction.~     Ibudilast (the study drug) is a drug that could help people addicted to methamphetamine.~      The investigators are interested to know if the study drug can help some symptoms that~     methamphetamine can cause, specifically inflammation in the brain. Inflammation has been~     shown to affect decision-making. The study drug has anti-inflammatory properties, however it~     is not yet known whether the drug will reduce inflammation in the brain.~   "
17258|NCT03341065|"~     Comparisons of Two Types of Robot Assisted Gait Training: Exoskeleton Type Robot vs.~     End-effector Type Robot: Randomized Controlled Trial~   "
17259|NCT03341052|"~     It is unknown whether the bile acid pathway is altered in obesity. This study is designed to~     compare obesity and health to determine if the bile acid pathway differs depending on health~     state.~   "
17260|NCT03341039|"~     The primary objective of this study is to assess the efficacy and safety of PHIL® liquid~     embolic agent in endovascular embolization of cerebral arteriovenous malformations.~   "
17261|NCT03341026|"~     The aim of the present study is to investigate the clinical performance of the Metronom CGM~     system in patients with type 1 diabetes over a period of 14 days. In this study, the CGM~     sensor will be tested in an inpatient setting (meal/insulin test with frequent plasma glucose~     monitoring) at different days of wear-time. Sensor data will be compared to gold standard~     reference (Super GL2 analyser or YSI) and stability of sensor performance will be assessed~     over time. Additionally, safety and tolerability of the sensor will be investigated by~     regular assessment of the insertion site.~   "
17262|NCT03341013|"~     This is a randomized, open label, cross-over, two-period, pilot study in healthy adult~     subjects to evaluate the bioequivalence between formulation 2 and formulation 3 of MEDI0382~     after a single subcutaneous (SC) dose. The study will be conducted at a single US center.~     Each subject will be randomized to receive a single 100 μg (or equimolar equivalent) SC dose~     of both formulation 2 and 3 of MEDI0382 on two different in-house periods separated by a~     washout period of 7 days. Formulation 3 of MEDI0382 has not been administered to humans~     previously. Blood samples for PK analyses of MEDI0382 concentrations will be taken predose~     and at 11 time points up to 48 hours after dosing (Days 3 and 12). Bedside plasma glucose~     levels will be monitored before meals and at bedtime during Days 1 and 10 and will be~     measured prior to breakfast on Days 2 and 11.~   "
17263|NCT03341000|"~     This study evaluates use of DISCSS vis SCS. Thirty (30) patients with back pain greater than~     leg pain who were candidates for Spinal Cord Stimulation (SCS) and have successfully~     completed a percutaneous trial with a commercially available SCS system will be trialed with~     a 3-4 day exposure to the investigational DISCSS™ device. The trial will be conducted at 3-5~     U.S. centers. The percutaneous trial leads from the commercial system will be connected to~     the External Pulse Generator of the DISCSS™ Trial System and the patients will be trialed for~     an additional three-four days.~   "
17264|NCT03340987|"~     Patients with multiple recession defects will be randomly oriented into to groups. The test~     group will recieve a relatively new technique, the VISTA technique, combined with connective~     tissue graft that will be harvested from the palate. The control group will recieve coronally~     advanced flap with connective tissue graft. subjects will be followed up for 6 months after~     the surgery. Any complications, that may occur, will be dealt with.~   "
17265|NCT03340974|"~     The purpose of the phase I/II clinical study is to determine the best dose of fractionated~     stereotactic radiation therapy (SBRT) given either with GC4419 or placebo to patients who~     have been diagnosed with locally advanced pancreatic cancer.~   "
17266|NCT03340961|"~     Clinical assessments of efficacy will be conducted based on Investigator's Global Assessment~     (IGA, modified scale without erythema), Clinician's Erythema Assessment (CEA), and on~     inflammatory lesion counts at Weeks 4, 8, 12 and 16 in comparison to Baseline.~   "
17293|NCT03340610|"~     This is a phase 4 prospective, nonrandomized, open label, interventional clinical trial.~     Study eyes will receive 5 required initial monthly IAI doses of 2 mg followed by 2q8 IAI for~     a total of 52 weeks; only one study eye from each patient will be enrolled.~   "
17268|NCT03340935|"~     In preclinical studies, cyclic calorie-restricted diets reduce the risk of several cancers~     and improve the antitumor activity of standard treatments against already established~     malignancies.In particular, the fasting mimicking diet (FMD), a plant-based,~     calorie-restricted, low carbohydrate, low-protein diet to be repeated cyclically every 3-4~     weeks, enhances the antitumor activity of cytotoxic chemotherapy, while contemporarily~     protecting healthy tissues and stimulating antitumor immunity. Most of these effects are~     likely mediated by the reduction of blood glycemia and growth factors, such as insulin and~     insulin-like growth factor 1 (IGF-1). When administered to healthy volunteers, cyclic FMD has~     been shown to be safe and capable of reducing risk factors for different chronic diseases.~     However, the effects of the FMD in cancer patient populations have not been evaluated so far.~     This study aims to assess the safety, feasibility and metabolic effects of the FMD in cancer~     patients treated with different standard antitumor therapies. Patients with any malignancy,~     with the exception of small cell neuroendocrine tumors, will be considered for enrollment in~     this study. The FMD will be administered up to a maximum of 8 consecutive cycles in~     combination with standard adjuvant treatments or therapies for advanced disease.~   "
17269|NCT03340922|"~     Current navigation systems incorporate algorithms for automatic identification of local~     activation time (LAT). However, data about their utility and accuracy in premature~     ventricular complex (PVC) ablation procedures are scarce. This prospective, randomized study~     analyzes the accuracy and effectivity of an algorithmic method based on automatic annotation~     of the maximal negative slope of the unipolar electrogram within the window demarcated by the~     bipolar electrogram, compared with conventional, manual annotation during PVC ablation~     procedures.~   "
17270|NCT03340909|"~     Objective: The primary objective of this trial is to investigate whether prednisolone~     improves symptom severity as compared to placebo when given in addition to antipsychotic~     medication to patients with early-stage psychotic disorder. Secondary objectives include~     improvement of cognitive functioning and positive, negative and general psychopathological~     symptoms as well as general functioning.~      Study design: Randomized placebo-controlled double-blind trial. Study population: 90 men and~     women, with an age of 18 years and older, diagnosed with schizophrenia spectrum disorder. The~     time interval between the onset of psychosis and study entry should not exceed five years and~     CRP level should be at least 3.9 mg/L.~      Intervention: Patients will be randomized 1:1 to either prednisolone or placebo daily for a~     period of 6 weeks. Identical tablets will be administered. Prednisolone will be initiated at~     40 mg for three days, after which it will be phased out within 6 weeks after start, following~     current treatment guidelines.~      Main study parameters/endpoints: Primary outcome is change in symptom severity, expressed as~     a change in total score on the Positive and Negative Symptom Scale (PANSS) from baseline to~     end of the 6-week treatment. Secondary outcomes are a 6-month follow-up assessment of PANSS,~     cognitive functioning (measured through a repeatable neurocognitive battery, change in GAF~     scores and the measurement of various immunological biomarkers. In post-hoc analyses,~     attempts will be made to identify baseline blood markers with predictive properties regarding~     improvement in the anti-inflammatory drug treatment arm.~      Expected benefits for consumers and care givers:~      A decrease in symptom severity is expected, as low grade brain inflammation may be associated~     with psychotic symptoms. The results may give raise to a new line of scientific research as~     well as treatment options for a disabling disorder.~   "
17271|NCT03340896|"~     This study compare the survival without laryngeal dysfunction 2 years after the end of~     treatment, obtained by chemotherapy followed by radiotherapy or chemotherapy with cisplatin~     administrated during radiotherapy.~   "
17272|NCT03340883|"~     This is a Phase 1/2 study designed to evaluate the safety and tolerability of BION-1301 in~     adults with relapsed or refractory multiple myeloma whose disease has progressed after 3 or~     more prior systemic therapies.~   "
17273|NCT03340870|"~     The primary purpose of this study is to determine the Pharmacokinetics (PK) data of~     perfluorobutane (PFB) in blood and exhaled air following intravenous (I.V.) bolus injection~     of Sonazoid™ in healthy volunteers.~   "
17274|NCT03340857|"~     The purpose of this pilot study is to encourage oncology patients to continue effort~     retraining after their release from rehabilitation and recuperative care facilities with~     physical activity sessions and therapeutic education using an intelligent electric bicycle~     (VELIS)~   "
17275|NCT03340844|"~     This multicentre, prospective and randomized study aims(1:1) to compare the rate of~     recurrence, metastasis and survival according to the levels of intraoperative circulating~     tumor cells (CTCs) during cephalic duodenopancreatectomy in patients with pancreatic and~     periampullary tumors.~   "
17276|NCT03340831|"~     Evaluate safety of non-adjunctive CGM use in CGM naive participants.~   "
17277|NCT03340818|"~     A double-blind, placebo-controlled study to determine the efficacy of intradiscal injection~     of bone marrow concentrate on discogenic low back pain.~   "
17278|NCT03340805|"~     The objective of this pilot study is to assess overall feasibility prior to embarking on a~     larger randomized pragmatic trial comparing the clinical effectiveness of fluid resuscitation~     with NS versus LR for pediatric patients with suspected septic shock. Necessary feasibility~     assessments include ensuring appropriate compliance with study fluid in each of the two arms,~     effectiveness of study enrollment using a pragmatic study design embedded within routine~     clinical practice, and acceptability of using Exception from Informed Consent (EFIC).~   "
17279|NCT03340792|"~     The present study aims to investigate the effects of ReWalk exoskeleton robot training on~     various physiological and psychological parameters among subjects with spinal cord injury,~     including body composition and bone mineral mass, balance ability, bowel and bladder~     symptoms, severity of pain, psychological well-being, and quality of life. Ten patients with~     paraplegia caused by spinal cord injury will be recruited from the out-patient clinic of~     Department of Physical Medicine and Rehabilitation at the China Medical University hospital.~     All participants will undergo dual X-ray absorptiometry to evaluate the baseline bone mineral~     density. Eligible participants will then take ReWalk training sessions comprises of 3 x~     1-hour sessions per week for 40 sessions. A comprehensive battery of outcome measures,~     including body composition and bone mineral mass, balance ability, bowel and bladder~     symptoms, severity of pain, psychological well-being, and quality of life, will be utilized~     for comparison after 40 sessions of ReWalk ambulation training.~   "
17294|NCT03340597|"~     A Phase I, open label study evaluating safety, tolerability and pharmacokinetics of F901318~     in healthy subjects following up to 28 days dosing, where F901318 is given orally . The~     effect of food upon the pharmacokinetics of F901318 and the effect of F901318 upon the~     pharmacokinetics of midazolam will also be assessed.~   "
19434|NCT03312582|"~     This study evaluates the efficacy of 1% local metformin gel in deep periimplant pockets of~     type 2 diabetes mellitus patients. Half of the participants will receive 1% metformin gel~     with manual debridement while the other half will receive a placebo with manual debridement.~   "
17280|NCT03340779|"~     Cardiogenic shock is a frequent cause of admission and death in the intensive care unit.~      Mortality is about 50%. Once the etiologic treatment has been done, for instance coronary~     revascularization, management of the shock state is the cornerstone of the treatment.~     Norepinephrine is the first-line vasopressor therapy because of its minor effect on heart~     rhythm. Morever norepinephrine is a inotrope. In a previous study, we demonstrated that~     increasing the norepinephrine dose increases cardiac index, cardiac power index, SVO2 and~     tissue perfusion without acceleration of heart rate. Nevertheless, dobutamine remains the~     first-line inotropic treatment. Dobutamine has a positive chronotropic effect that might~     cause higher myocardial oxygen consumption. As a result, combination of vasopressor /~     inotrope is still controversial.~      The aim of this study was to compare hemodynamics and metabolics effects of 2 treatments~     strategies (norepinephrine dose increasing or addition of dobutamine) in patients with~     cardiogenic shock and optimised blood pressure level (MAP≥65 mmHg) under norepinephrine~     treatment.~      The secondary objectives were :~        -  To evaluate the efficacy of the treatments on micro- and macrocirculation parameters~        -  To evaluate the tolerance of the treatments~        -  To evaluate the dose and the admistration's kinetics of the treatments~   "
17281|NCT03340766|"~     Phase 1b: To determine the maximum tolerated dose (MTD) of blinatumomab in combination with~     pembrolizumab in adult subjects with relapsed or refractory (r/r) DLBCL~   "
17282|NCT03340753|"~     This is an open-label, partial crossover, single-dose study to evaluate the pharmacokinetics~     (PK), dose proportionality, and safety/tolerability of tablet versus capsule formulations of~     KBP-5074 in healthy subjects. The study is designed to evaluate the PK of a new tablet~     formulation versus that of the current capsule formulation. Data derived from this study, in~     addition to preclinical data and chemistry, manufacturing, and controls, will provide a basis~     for dose selection in future studies.~   "
17283|NCT03340740|"~     The purpose of this study is to determine the effect of cetirizine, an oral antihistamine, on~     wheezing in patients with allergic rhinitis. Patients presenting to the pediatric emergency~     department who have a history of allergic rhinitis and who are wheezing will be asked to~     participate. Half of patients will receive a dose of cetirizine and the other half will~     receive placebo and their response will be monitored over the course of their emergency~     department visit with vital signs, physical examinations, and measurement of~     bronchoconstriction with spirometry.~   "
17284|NCT03340727|"~     The objective of this study is to evaluate the effect of continuing treatment with caffeine~     citrate in the hospital and at home in moderately preterm infants with resolved apnea of~     prematurity on days of hospitalization after randomization.~   "
17285|NCT03340714|"~     This pilot early phase I trial studies the Automated Device for Asthma Monitoring and~     Management in monitoring adult patients with lung cancer who are undergoing radiation~     therapy. The Automated Device for Asthma Monitoring and Management may provide useful~     information to doctors to help monitor adult patients with lung cancer and diagnose certain~     conditions earlier than traditional means.~   "
17286|NCT03340701|"~     Pharmacokinetic analysis of 200mg vaginal progesterone suppository in women with singleton~     pregnancies between 18 0/7- 23 6/7 weeks' gestation~   "
17287|NCT03340688|"~     This is a multicenter randomized study designed to determine if ultrasound indicated cerclage~     reduces the incidence of spontaneous preterm birth <34 weeks in asymptomatic women with twin~     gestations and cervical length ≤15mm, diagnosed by transvaginal ultrasound between 16 to 23~     6/7 weeks of gestation.~   "
17288|NCT03340675|"~     Duchenne muscular dystrophy (DMD) is a devastating X-linked disease which leads to loss of~     ambulation between ages 7 and 13, respiratory failure and cardiomyopathy (CM) at any age, and~     inevitably premature death of affected young men in their late twenties. DMD is the most~     common fatal genetic disorder diagnosed in childhood. It affects approximately 1 in every~     3,500 live male births across all races and cultures, and results in 20,000 new cases each~     year worldwide.Significant advances in respiratory care have unmasked CM as the leading cause~     of death. As there are yet no specific cardiac treatments to extend life, the current study~     aims to address this unmet medical need using a new therapeutic strategy for patients with~     DMD.~   "
17289|NCT03340662|"~     This is a phase 1 open-label 4-part study to evaluate the effect of food, cytochrome P450~     inhibition and induction on the pharmacokinetics of CC 122 in healthy adult subjects.~     Approximately 81 subjects will be enrolled. There will be approximately 24 subjects in Part 1~     and approximately 19 subjects in Parts 2, 3, and 4, respectively. Subjects may participate in~     1 part only.~   "
17290|NCT03340649|"~     To observe the changes of plasma hepatocyte growth factor and soluble receptor s-Met levels~     in patients with sepsis, and to explore its clinical significance.~   "
17291|NCT03340636|"~     To date, Sorafenib is the only drug therapy to have demonstrated a benefit in overall~     survival in patients with advanced or metastatic hepatocellular carcinoma. However, this~     treatment causes many adverse effects that may limit its prescription.~      Under these conditions, predicting and therefore potentially preventing the adverse effects~     of sorafenib is a major issue in the management of patients with hepatocellular carcinoma~     treated with this drug.~      Currently, there is little data available on the correlation between the pharmacokinetics of~     sorafenib and the side effects of this drug in patients treated for hepatocellular carcinoma.~      Investigators propose an observational cohort study evaluating the correlation between~     residual plasma concentration of sorafenib and the risk of severe adverse effects (grades~     3-5) in treatment in patients treated for hepatocellular carcinoma on cirrhosis.~      This study should include 60 patients over an expected duration of 12 months. The aim of this~     work is to determine whether there is a correlation between the residual plasma concentration~     of sorafenib and the occurrence of severe adverse effects (grades 3-5) at treatment in~     patients treated for hepatocellular carcinoma on cirrhosis as well as potential influence of~     the etiology of cirrhosis on this relationship. The ultimate ambition is to be able to~     anticipate and thus prevent these adverse effects in order to increase the safety of the drug~     and potentially its effectiveness.~   "
17292|NCT03340623|"~     This is a retrospective study performed on medical records, in order to compare the number of~     venous thromboses, the surgery duration, the complications rate and the duration of~     anastomosis in breast reconstructive surgeries by the DIEP (Deep Inferior Epigastric~     Perforator Flap) technique, with or without the use of a venous coupler.~   "
17295|NCT03340584|"~     The investigators will conduct a single-blind, randomized controlled trial of 100 patients~     with total knee replacement. Patients will be randomly assigned into a control group and an~     intervention group.Both groups received same rehabilitation procedures after surgery,except~     intervention group also received taping applications throughout all rehabilitation~     period.Then, the patients will be reevaluated to determine changes in lower extremity~     function, edema, pain,knee range of motion, and muscle strength of quadriceps femoris and~     hamstring.~   "
17296|NCT03340571|"~     Currently, no cures or disease modifying therapies exist for Alzheimer's disease (AD). This~     is partially due to the inability to detect the disease before it has progressed to a stage~     where there are clinical manifestations. The identification and validation of high throughput~     biomarkers to measure disease progression (as well as identify pre-clinical disease onset) is~     critical to the development of disease-modifying or even preventative therapies. In this~     study, we are testing a blood biomarker for stratification of Alzheimer's disease patients~     and healthy volunteers. This study may lead to future blood tests that may help earlier~     diagnosis of Alzheimer's disease and detect the disease progression.~   "
17297|NCT03340558|"~     This study is for patients with metastatic colorectal cancer who are candidates for resection~     of metastases. This study will be conducted sequentially with 2 cohorts: 1.) Monotherapy~     Cohort and 2.) Combination Cohort~      Pre-metastatectomy~        -  Monotherapy Cohort: The first 10 subjects will receive Atezolizumab 840 mg IV on Day 1~          and Day 15 of each 28-day cycle.~        -  Combination Cohort: The next 15 subjects will receive Atezolizumab 840 mg IV on Day 1~          and Day 15 and Cobimetinib 60 mg PO on Days 1-21 of each 28-day cycle. Note: Cobimetinib~          must be held for the 7 days prior to metastatectomy.~      All subjects will be treated for 2 cycles (8 weeks) prior to metastatectomy~      Metastatectomy~      Subjects will undergo liver metastatectomy within 42 days of completion of Cycle 2 of~     pre-metastatectomy treatment. No study treatment is administered while the patient is healing~     after surgery.~      Post-metastatectomy~      Once the patient has healed from the surgery, adjuvant treatment may be administered at the~     discretion of the treating physician. Restaging following standards of care for this setting.~   "
17298|NCT03340545|"~     Low back pain is a major cause of disability, especially in the working-age population. A~     total of 149 million working days are lost every year as a consequence of back pain.~     Intervertebral disc (IVD) degeneration is thought to play a major role in chronic back and~     neck pain. Decades of bench-top research in tissue mechanics have shown clear relationships~     between changes in mechanical properties and abnormal changes IVD structure and composition.~     Our overall hypothesis is that measurements of IVD mechanical properties can provide valuable~     information about its structure and composition for early diagnosis of degeneration,~     quantification of degeneration progress, and evaluation of treatment strategies. Magnetic~     Resonance Elastography (MRE) is an imaging method to quantify mechanical properties from soft~     tissues. The objectives of this study are to evaluating repeatability and collecting base~     line data from healthy individuals; and to apply MRE to patients with disc herniation.~   "
17299|NCT03340532|"~     To assess the efficacy of the two SunSmart intervention videos to change sun protection~     attitudes and behaviors~   "
17300|NCT03340519|"~     The investigators plan a prospective study designed to optimize and translate noncontrast,~     novel Magnetic Resonance Imaging (MRI) techniques for detecting and measuring intestinal~     inflammation as well as for allowing early prediction of response to medical therapy in small~     bowel Crohn's Disease (CD).~   "
17301|NCT03340506|"~     This study is to provide access for patients who are receiving treatment with dabrafenib~     and/or trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs~     or a former GSK-sponsored study who have fulfilled the requirements for the primary~     objective, and who are judged by the investigator as benefiting from continued treatment n~     the parent study as judged by the Investigator at the completion of the parent study.~   "
17302|NCT03340493|"~     Patients presenting to the emergency department with acute ischemic stroke, who are eligible~     for standard intravenous thrombolysis within 4.5 hours of stroke onset will be assessed for~     major vessel occlusion to determine their eligibility for randomization into the trial. If~     the patient gives informed consent they will be randomised 50:50 using central computerised~     allocation to either 0.4mg/kg or 0.25mg/kg intravenous tenecteplase before all participants~     undergo endovascular thrombectomy. The trial is prospective, randomised, open-label, blinded~     endpoint (PROBE) design.~   "
17303|NCT03340480|"~     The purpose of this study is to evaluate the food effect on the pharmacokinetics of NVP-1402~     in healthy male volunteers.~   "
17304|NCT03340467|"~     Within the present study 4 different band-aid/adhesive combinations will be tested in~     patients with type 1 diabetes and type 2 diabetes with regard to adherence to the body and~     allergic potential. The study period is set to 21 days following adhesive material placement~     to cover the maximum expected wear-time of the novel CGM system (14 days) plus an additional~     seven days to ensure that adhesive material is tested for a sufficient time-period and~     differences in adhesion can clearly be observed. A sub-study will be conducted with patients~     only enrolled at Medical University Graz. The sub-study is conducted to analyse the~     individual pain perception during the insertion process and to asess the easiness of sensor~     insertion by three different insertion methods.~   "
17305|NCT03340454|"~     This study will assess the efficacy, adoption, and impact of an integrated intervention to~     improve adherence to recommended stomach cancer prevention guidelines (H. pylori~     test-and-treat) for at-risk Chinese Americans in NYC. The integrated multifaceted~     theory-based intervention involves: 1) a health systems-level intervention using electronic~     health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies; and 2) a~     community-engaged culturally and linguistically adapted CHW-led patient navigation program we~     are currently pilot testing for feasibility and acceptability. Using a 2-arm randomized~     controlled trial (RCT) design, 144 Chinese American patients across NYC safety net hospital~     endoscopy clinics will participate.~   "
17306|NCT03340441|"~     The purpose of the study is to evaluate the temperature measurements by the Prizma device.~   "
17329|NCT03340142|"~     A multi-center study designed to assess the accuracy of VIVO™ in determining the location of~     a PVC/VT foci in comparison to an electroanatomical mapping system.~   "
19435|NCT03312569|"~     To compare intracorporeal and extracorporeal anastomoses for robotic-assisted and~     laparoscopic right colectomies~   "
17307|NCT03340428|"~     HIV remains the leading cause of death in South Africa as a result of a failure of people~     living with HIV to seek HIV treatment and be retained in care. After initiating~     antiretroviral therapy while incarcerated, most ex-inmates fail to remain engaged in care.~     The goal of this research is to reduce mortality, morbidity, and HIV transmission by~     developing an actionable approach to retaining these individuals in HIV care.~   "
17308|NCT03340415|"~     Investigate the optimal timing for weight bearing after Hallux Valgus surgery. Hypothesis:~     Early weight bearing does not affect outcome after the Endoscopic Distal Soft Tissue~     Procedure for Hallux Valgus Correction.~   "
17309|NCT03340402|"~     This research study is studying an intervention as a possible treatment for Triple Negative~     Breast Cancer.~   "
17310|NCT03340389|"~     To study the correlations among the dysfunctional lens index (DLI), Lens Opacities~     Classification System III (LOCS III) nuclear opalescence grading score, preoperative~     corrected distance visual acuity (CDVA), the objective scatter index (OSI) and Scheimpflug~     based average lens density in age-related cataracts. To investigate the potential of the DLI~     as a novel surgery decision maker via the Operating Characteristic (ROC) curve analysis.~   "
17311|NCT03340376|"~     This is an open-label, multicenter, randomized phase II trial to evaluate the safety and~     efficacy of atezolizumab in patients with recurrent cervical cancer in second line therapy. A~     total of 48 patients will be randomized in 3 arms, each arm consisting of 16 patients:~      Arm A: atezolizumab monotherapy q3w Arm B: atezolizumab combined with doxorubicin q3w Arm C:~     doxorubicin monotherapy q3w~   "
17312|NCT03340363|"~     The purpose of this study is to examine the impact of environmental modifications (choice~     architecture and a marketing campaign) in combination with weekly text messages on purchases~     of foods made by parents shopping in a large supermarket.~   "
17313|NCT03340350|"~     The study will evaluate the safety and efficacy of adjunctive minocycline treatment in~     veterans with PTSD.~   "
17314|NCT03340337|"~     Muscle strength is the amount of force generated by muscle contraction. It could be measured~     in isometric, isotonic or isokinetic activity, either manually or using a dynamometer.~      The isometric dynamometer is a validated and cheap tool that could be used to measure Maximal~     Voluntary Isometric Contraction (MVIC) and Maximal Electrical Induced Contraction (MEIC). It~     is claimed that higher MEIC values will result in more force gained.~      If a current is more tolerated it will be easier to achieve better MEIC values. Tolerance to~     an electrical stimulation could be measured with the Visual Analogue Scale (VAS). A ratio~     between Normalized MEIC / VAS is often used, implying that the current is better with a~     higher ratio.~      Muscle fatigue is defined as a temporary loss or decrease in force-generating ability due to~     previous contractions. It is claimed that medium frequency neuromuscular electrical~     stimulation (NMES) generates more fatigue than low frequency currents.~      Aussie current is a newer medium-frequency alternating current which consists in a sinusoidal~     waveform, 1 KHz carrier frequency.~      Neo-Russian current is also a medium-frequency current with a rectangular biphasic~     symmetrical waveform, 2,5 KHz carrier frequency.~      Rectangular Biphasic symmetrical (RBS) waveform is a type of Low Pulsed Current (LPC),~     claimed to be better than classical Russian Current.~      Purpose:~      As it has been claimed that LPC is better in MEIC and tolerance, the aim of this study is to~     compare it with two newer medium frequency currents in terms of MEIC, tolerance and fatigue.~      Methods:~      Thirty male subjects, right leg dominant, will receive randomly the 3 types of electrical~     stimulation. Before that, the MVIC will be measured for data normalization.~      The MVIC and MEIC will be measured with an isometric dynamometer. In both measurements,~     subjects will be asked to perform three reps (5 sec work x 120 sec rest) and the best one~     will be used.~      To apply Aussie electrical stimulation, an Aussie Sport (Ibramed) will be used. To apply~     Neo-Russian, a Neurodyn III (Ibramed) will be used. To apply RBS, a Genesy (Globus) will be~     used.~      The VAS will be used to assess tolerance to each treatment. A ratio between MEIC and VAS will~     be calculated.~      One week later, the subjects will receive, randomly, a fatigue protocol that consists in 21~     reps of electrical stimulation with the three types of current. The data will be normalized~     with the MVIC and the reps equal or below 50 % of the first rep will be considered as a~     fatigue rep.~   "
17315|NCT03340324|"~     Endometriosis is a chronic gynecological disease characterized by sustained painful symptoms~     that are responsible for a decline in the quality of life of sufferers. Endometriosis is~     fairly common, affecting an estimated 10%-15% of women and girls, usually during their~     reproductive years. Based on these rough estimates, the latest epidemiological studies~     suggest that over 200 million women are might be affected who may commonly have infertility~     problems. V-Endo is a tableted preparation derived from hydrolyzed, heat-inactivated, pooled~     blood of women with endometriosis. When taken orally it is postulated to cause the immune~     tolerance and anti-inflammatory effect as a result.~   "
17316|NCT03340311|"~     Gestational diabetes mellitus (GDM) can cause adverse outcomes for the mother and fetus due~     to hyperglycemia. The purpose of this study is to evaluate the feasibility of improving~     pregnant women's glucose logs using a Bluetooth enabled glucose monitor and associated mobile~     health application and to assess their satisfaction with using mobile health technology.~   "
17317|NCT03340298|"~     This parallel feeding trial was carried out in Isfahan, Iran between January 2016 till July~     2016. Overweight and obese participants referred to nutrition clinic , were recuruited~     through explanation of the study and completion of the written consent form for admitted~     ones. The sample size was calculated based on the formula by considering α (type 1~     error)=0.05 and β(type 2 error)= 0.20 , d=25 and SD= 2.6 according to the published article,~     was obtained 17 . Therefore , according to the formula 17 subjects were needed in each group~     ,considering the probable dropouts, we assigned 25 subjects for each feeding group to meet~     the adequate power. Before beginning of the trial all baseline levels of FBS, Plasma Insulin,~     TG, Total Cholestrol, LDL-C, HDL-c and hs-CRP was measured and anthropometric assessment like~     height, weight , weistcircumistance and also systolic and diastolic Blood pressure was~     performed as well.All three groups used high fiber food items consist of 35 grams fiber per~     day.Whole grain intervention group provided 25 gram from whole grain products and 10 gram~     from fruits and vegetables .In contrary , Fruits and Vegetables group provided 25 gram fiber~     from fruits and vegetables as main supplier and the remaining 10 grams from whole grain~     sources.In the third group equal proportion from both sources was provided (15 gram from~     whole grain and 15 gram from fruits and vegetables). Required energy intake was calculated~     based on Harris-Benedict formula and decreased energy intake for 0.5 kilogram weight -loss in~     each week was considered for subjects. A dietitian calculated energy requirement for all~     participants separately,then based on macronutrient component of 55% of energy intake from~     carbohyderate, 15% from protein and 30% from fats, the servings number for each food groups~     was obtained and was given to individuals. clinic. In two other intervention groups the same~     procedure was conducted as well.To implement a diverse diet for each 3 groups in addition to~     exchange list, a list of containing food groups and subgroups was provided. Every two weeks~     all subjects were assessed for food intakes and anthropometric measurements.Participants were~     requested to do physical activity and food intakes record between visit intervals.Assessment~     of anthropometric and biochemical indices was performed both before and at the end of trial~   "
17318|NCT03340285|"~     The study is designed evaluate the effects of a new combination of nutraceuticals (AkP 06)~     without Monacolin K on lipid and glucose metabolism.~      The study will analyze the impact of 4 weeks treatment with Akp06 or placebo, according to a~     randomized scheme, on metabolic parameters in dyslipidemic subjects that do not require or~     not tolerate a statin therapy. In particular, it will assess the ability of AkP 06 to reduce~     the plasma levels of LDL cholesterol, HbA1C, glicaemia and fasting insulin and to increase~     those of HDL cholesterol.~      In addition, effects on serum transaminase and creatine phosphokinase (CPK) concentration~     will be evaluated.~   "
17350|NCT03339869|"~     This research targets four anti-infectives commonly prescribed in intensive care:~     ceftazidime, cefepime, cefotaxime and meropenem, used for severe infections For patient~     hospitalized in intensive care unit , there is little or no pharmacokinetic data for these~     four molecules.~   "
17319|NCT03340272|"~     The general aim of the study is to describe the use of elective pelvic node irradiation (ENI)~     in Italy, in patients with intermediate/high/very high-risk prostate cancer patients~     submitted to adjuvant or radical Radiation Therapy (RT) with or without concomitant Androgen~     Deprivation hormone Therapy (ADT).~      The study aims at the definition of survival, toxicity and QoL data in a representative~     sample of intermediate, high and very high risk prostate cancer patients consecutively~     recruited in Italian Radiation Oncology Center over two years.~   "
17320|NCT03340259|"~     The human microbiota, a collection of microorganisms mostly settled in the gastrointestinal~     tract, plays a major role in the maintenance of the hosts' health and in development of~     disease as well. Exposure to different conditions early in life contributes to distinct~     pioneer bacterial communities, which shape the newborn infants' development and influence~     their later physiological, immunological and neurological homeostasis. Newborn infants with~     congenital malformations of the gastrointestinal tract (CMGIT), necrotizing enterocolitis~     (NEC), and spontaneous intestinal perforation (SIP) commonly require abdominal surgery and~     enterostomy. While intestinal microbiota has been extensively studied in infants with~     anatomically uninterrupted intestine, the knowledge of longitudinal intestinal colonization~     in this population is scarce.~      This is an exploratory, observational, and longitudinal prospective study, primarily aimed to~     determine longitudinally the colonization of the proximal remnant intestine, in newborn~     infants with enterostomy after surgery (three weeks) for CMGIT, NEC and SIP. The secondary~     aim is to explore the associations of the colonization with the mode of delivery, gestational~     age, postnatal age, duration of fasting, type of enteric feeding, antimicrobial therapy,~     H2-receptor antagonist therapy, and length of proximal remnant intestine.~   "
17321|NCT03340246|"~     Varicose veins affect a majority of adult patients and cause a decreased quality of life. In~     recent years, standard practice has been to perform thermoablation and local phlebectomies in~     the same procedure. There is conflicting data on the long-term outcome of the local varicose~     veins; there seems to be a need for more re-interventions if the local varicosities are not~     treated immediately. On the other hand, the prolonged combined procedure increases procedural~     pain and bleeding, as well as the risk for complications from deep vein thrombosis/pulmonary~     embolism.~      This trial aims to evaluate the need for immediate treatment of local varicosities and the~     potential sufficiency of main trunk treatment.~   "
17322|NCT03340233|"~     Heart failure is a clinical syndrome marked by breathlessness, even at low levels of~     exertion, general fatigue, and fluid retention and is estimated to affect 5.1 million people~     in the United States. Heart failure with preserved ejection fraction (HFpEF) means that the~     heart pumps enough blood to the body, but patients still have terrible symptoms. It is~     estimated to account for about 50% of all heart failure cases. Experts agree that impaired~     filling of the heart, perhaps due to stiffness of the heart muscle itself, critically~     underlies HFpEF. There is currently no clinical technique for measuring heart muscle~     (myocardial) stiffness; the very definition of myocardial stiffness remains poorly~     established. Consequently, the ability to study the mechanisms that underlie HFpEF is~     virtually non-existent, and limited treatment options will persist without significant~     advances. The objective of this project is to use an Equilibrium-Material-Stability (EMS)~     framework that couples patient-specific clinical MRI and heart pressure data in a~     computational model of the heart to diagnose changes in myocardial stiffness. The central~     hypothesis is that the new EMS framework for understanding the mechanisms of diastolic~     dysfunction in HFpEF will be more sensitive and outperform currently available approaches.~   "
17323|NCT03340220|"~     The XEN1101 Phase 1 clinical trial is a randomized, double-blind, placebo-controlled study~     that will evaluate the safety, tolerability and PK of both single ascending doses (SAD) and~     multiple ascending doses (MAD) of XEN1101 in healthy subjects. In addition to safety and PK~     data, the clinical trial has been designed to include a pharmacodynamic read-out by~     incorporating a pilot transcranial magnetic stimulation (TMS) sub-study. The TMS model~     sub-study is designed to demonstrate delivery of XEN1101 into the central nervous system and~     to observe a change in cortical excitability as measured by EEG and/or EMG activity. It is~     estimated there will be approximately 64 subjects in the planned SAD and MAD cohorts.~   "
17324|NCT03340207|"~     Pneumaglide is a device designed to facilitate intubation. Patients who are undergoing a~     surgical procedure under general anesthesia and will require placement of endotracheal tube~     will be screened and upon fulfilling the inclusion criteria will be randomized to PneumaGlide~     group or non-PneumaGlide group. After induction of anesthesia PneumaGlide device will placed~     in the mouth of the Pneumaglide assigned subject. The time for intubation will be measured~     from the time that the laryngoscope is inserted into the mouth until the trachea is~     successfully intubated and compared between the groups. Oxygen saturation drop below 90% and~     also gastric secretion spillage will be compared between two groups as well.~   "
17325|NCT03340194|"~     Systemic sclerosis is a rare pathology characterized by fibrosis and vascular lesion with~     skin, pulmonary, digestive and cardiac localisation. Calcinosis cutis is commonly described,~     but its prevalence and appear few documented in literature. Moreover, this studies used~     clinical observation to determine presence or absence of calcification, and rarely~     radiography, in particular for feet localisation. In the same way, skin calcification and~     organ injury association appear unclear. The aim of the study is firstly to determine~     prevalence of calcinosis cutis, with hand and feet radiography realisation in a cohort of~     systemic sclerosis patient. Secondly, will be determine the correlation between calcinosis~     and organ injury.~   "
17326|NCT03340181|"~     The purpose of the study was to verify the myocardial protective effect of RIPC in patients~     undergoing OPCABG.~   "
17327|NCT03340168|"~     The time course of bisphenol S in plasma and urine will be monitored in female adults exposed~     to a single oral and dermal dose of bisphenol-S. Six female will be recruited. Blood and~     urine will be collected at specified times post-treatment. Bisphenol concentrations will be~     measured in those samples.~   "
17328|NCT03340155|"~     The molecular mechanisms of action of photo(chemo)therapy in skin diseases are investigated~     in this study. The phototherapeutic modalities employed include UVB (ultraviolet B), UVA~     (ultraviolet A), PUVA (psoralen+UVA) and/or extracorporeal photochemotherapy (photopheresis).~     The study will address whether and how photo(chemo)therapy affects specific biologic pathways~     in different skin disorders and search for predictive biomarkers.~   "
17330|NCT03340129|"~     This is a phase II, open label, non-randomised study of ipilimumab and nivolumab, with~     salvage radiotherapy, in adult patients with melanoma brain metastases. All patients will be~     in a single systemic treatment group at study entry and will receive 12 weeks of ipilimumab~     and nivolumab, followed by nivolumab monotherapy until confirmed disease progression, drug~     toxicity or death. Patients may be treated beyond progression if their treating clinician~     believes there is clinical benefit to do so.~      At brain MRI scans between 6 and 12 weeks after starting systemic therapy, patients who have~     RECIST-determined intracranial disease progression will receive salvage radiotherapy.~     Patients with fewer than 5 progressing metastases will receive stereotactic radiotherapy and~     patients with 6 or more progressing metastases will receive whole brain radiotherapy.~      The main aims of the study are to determine the objective response to systemic treatment and~     the intracranial progression free survival for patients who require salvage radiotherapy.~     Adverse events, neurocognitive function, quality of life and the study of tissue and blood~     biomarkers will also be examined.~   "
17331|NCT03340116|"~     Burn surgery is associated with significant reductions in hematocrit. However, it is unclear~     whether these reductions are the result of hemodilution from non-red cell containing~     intraoperative transfusions or from loss of red blood cells. The investigators will be using~     the Daxor Blood Volume Analyzer (BVA-100), an FDA approved instrument that can measure total~     blood volume, plasma volume, and RBC volume using the indicator dilution technique. By~     comparing pre-operative measurements of blood volume, plasma volume, and RBC volume to that~     of post-operative measurements after burn surgery, the investigators can determine the~     primary cause of the reduction in hematocrit associated with burn surgery. The investigators~     hypothesize that these reductions in hematocrit are primarily the result of hemodilution~     rather than blood loss and that there will be a statistically significant difference in~     measured plasma volume from the pre-operative group to the post-operative group.~   "
17332|NCT03340103|"~     Premature birth is the most common cause of mortality, morbidity and disability. Premature~     infants have a higher risk of developing damage in the eyes (retinopathy of prematurity ROP),~     in the central nervous system (intraventricular hemorrhage IVH), in the lungs (bronchial~     pulmonary dysplasia BPD), in the gut (NEC) and infections. Oxidative stress has been~     implicated in various capacities, in the etiology of these conditions. Lutein and Zeaxanthin~     are powerful anti-oxidants and commonly assimilated with different foods. Lutein and~     Zeaxanthin are present at level of umbilical cord, in the breast milk (particularly in~     colostrum) and pass the placental barrier. Concerning supplementations, the lutein presents,~     for its specific characteristics, a high bioavailability after oral administration. In the~     last few years, there have been more and more studies which have shown that lutein could~     constitute a valid and important preventive and protective factor against certain diseases~     related to oxidative stress. The preparations of lutein and zeaxanthin have never pointed out~     in the human being (included in the term newborn) adverse or toxic effects. This spontaneous~     / non-commercial pilot study involves the administration of a dietary supplement containing~     lutein / zeaxanthin, because the healthcare structures need to identify a natural antioxidant~     product that can reduce the incidence of serious diseases related to oxidative stress in the~     perinatal period. This study aims to evaluate if the administration of lutein in watery~     solution will reduce the rate of free radicals in preterm infants.~   "
17333|NCT03340090|"~     The study aim is to assess polyethylene glycol (PEG) coated collagen patch (Hemopatch) on the~     quality of drainage after surgery, the length of hospital stay, the number of reoperations~     due to haemorrhage and treatment cost. The study will be conducted in 200 patients undergoing~     Coronary Artery Bypass Grafting (CABG) with the use of extracorporeal circulation and~     Internal mammary Artery (IMA) harvesting. Traditional method of haemostasis will be applied~     in 100 patients and Hemopatch will be additionally used in 100 subjects to prevent~     haemorrhage after IMA harvesting and sternum closure.~   "
17334|NCT03340077|"~     Multicentre, randomised (1:1), controlled, open (not blinded) comparison of MOR toolkit~     (intervention) with standard pharmaceutical care (control)~   "
17335|NCT03340064|"~     This is a study to confirm the efficacy of Levetiracetam as adjunctive treatment in pediatric~     epilepsy subjects aged 1 month to less than 4 years of age with partial seizures.~   "
17336|NCT03340051|"~     Nearly 18% of United States adults meet criteria for alcohol dependence sometime in their~     lifetime, with only 24% of those individuals ever receiving any treatment for their disorder~     (Hasin et al., 2007). The pervasiveness of alcohol dependence indicates a need for continued~     development of high-impact treatments that are both effective and easily disseminated to a~     broad population. Recent evidence indicates that Episodic Future Thinking (EFT), the ability~     to self-project and pre-experience a future event, can help individuals to make changes to~     habitual behaviors, such as alcohol drinking (Snider et al., 2016). In this study, the~     investigators will evaluate the efficacy of EFT to help individuals reduce alcohol~     consumption. The investigators anticipate that EFT will result in a reduction in alcohol~     consumption over a 2-week experimental period when compared to the control group.~   "
17337|NCT03340038|"~     DESIGN: Non-inferiority Randomized Controlled Trial (RCT). Patients undergoing free flap~     reconstructive surgery at UCDMC will be assigned randomly into no intervention group~     (immediate post operative care in an Intensive Care Unit) or intervention group (immediate~     post operative care in a non-ICU specialty ward).~      HYPOTHESIS: There is no significant difference in the length of stay (LOS) or complication~     rate between head and neck free flaps patients managed immediately post-operatively in an~     Intensive Care Unit (ICU) versus a non-ICU specialty ward.~      OBJECTIVES:~      Primary Objective: To compare the postoperative LOS between head and neck free-flap patients~     managed initially in an ICU versus a non-ICU specialty ward.~      Secondary Objective: To compare differences in the rate of complications between head and~     neck free flap patients managed initially in an ICU versus a non-ICU specialty ward.~      Tertiary Objective: To compare differences in resource utilization between head and neck~     free-flap patients managed initially in an ICU versus a non-ICU specialty ward.~   "
17338|NCT03340025|"~     Various management options for free flap donor sites that require split thickness skin~     grafting exist. None has proven superior from both a patient care and a cost standpoint.~     Major complications occurring at these surgical sites include wound breakdown, tendon~     exposure, and loss of function. We seek to investigate the use of the PICO single-use~     negative pressure wound therapy device in these surgical sites and determine if it can yield~     superior results to simpler methods.~   "
17339|NCT03340012|"~     The treatment of intrabony defects in patients with aggressive periodontitis remains a~     challenging procedure and novel therapeutic strategies are sought. The purpose of this study~     is to compare the clinical and radiographic outcomes of using guided tissue regeneration~     (GTR) with radiation-sterilized allogenic bone grafts (material prepared in the Central~     Tissue Bank in Warsaw, Poland) versus guided tissue regeneration with xenogenic grafts~     (Bio-Oss®, Geistlich Biomaterials, Princeton, New Jersey, United States) in the treatment of~     localized intrabony defects in patients with aggressive periodontitis.~   "
17340|NCT03339999|"~     The purpose of this study is to evaluate the efficacy, safety, tolerability, pharmacokinetics~     and pharmacodynamics of 3 doses of AGN-242428 in adult participants with moderate to severe~     plaque-type psoriasis.~   "
17341|NCT03339986|"~     The aim of the study is to investigate and compare two strategies of portion control in~     toddlers aged 24 to 59 months (snack replacement and snack reduction). The investigators aim~     to compare the effect of these strategies on habitual dietary intake (total energy intake~     (kcal), sugar intake (g), intake of fruits and vegetables, and intake at a test meal provided~     in the home (total energy intake (kcal) and intake of each component of the meal, e.g. intake~     of vegetables). Outcome measures will be compared to baseline within strategies and also~     between strategies to explore which portion control strategy might be most effective.~   "
17342|NCT03339973|"~     The aim of this clinical trial is to investigate the efficacy (by monitoring the wound size~     reduction of Peripheral Arterial Occlusive Disease-related clinically relevant ulcers) and~     safety (by monitoring adverse events) of one dose of allo-APZ2-PAOD administered~     intramuscularly into an affected lower leg of patients with Peripheral Arterial Occlusive~     Disease.~   "
17343|NCT03339960|"~     Minimal invasive surgery has acquired increased importance and the number of procedures~     performed is ever growing. Laparoscopic surgery has several distinct key benefits for~     patients over open surgery and therefore it is considered as standard treatment for most~     general surgery procedures. These benefits include faster recovery, shorter hospital stay,~     reduced post-operative pain and improved cosmetic results.~      However, laparoscopy has an increased burden to surgeons and many surgeons experience fatigue~     and physical discomforts due to laparoscopy. Robotic systems have been developed to improve~     the ergonomics (among other things), with good results. Many of the laparoscopy disadvantages~     have been overcome by robotic assisted surgery, such as increased range of motion, correction~     of the inverted instruments, and elimination of tremors.(4) Moreover, visualization of the~     operation is improved by personal camera control and stabilization of the image.~      The AutoLap system, a video analytic robotic camera holder, has been developed to hold the~     camera in a stable manner. It enables the surgeon to control the camera and eliminates the~     need for coordination and communication between surgeon and assistants.~      This study aims to evaluate the ergonomics of the surgeon and assistant during laparoscopy~     with the aid of the AutoLap system and compare it to standard laparoscopy. Also, it will be~     assessed whether the AutoLap can reduce physical and mental discomfort of both the surgeon~     and the assistant.~      Objective This multicenter randomized controlled trial aims to compare ergonomics of the OR~     nurse and the surgeon during standard laparoscopic procedures with laparoscopic procedures~     aided by a robotic camera holder, the AutoLap system.~      Study design Prospective, interventional, open, multicenter randomized controlled trial. The~     study will be conducted in Wilhemina Hospital Assen and in Meander Medical Center Amersfoort.~      Study population~      Adults ≥18 years who are scheduled for the following procedures:~        -  Laparoscopic hiatal hernia repair / fundoplication~        -  Laparoscopic right hemicolectomy~        -  Laparoscopic sigmoid resection~        -  Laparoscopic rectopexy~        -  Laparoscopic low anterior resection~        -  Laparoscopic splenectomy~      Inclusion criteria~        1. Aged ≥ 18 years~        2. Fit for standard laparoscopic general surgery~      Exclusion criteria~        1. Contra-indications for laparoscopy~        2. Obesity (BMI >35 Kg/m2)~      Intervention AutoLap group: In the AutoLap group, the camera will be held by a robotic arm.~     Posture of the surgeon and the assistant will be recorded during standardized predefined~     steps of the procedure.~      Control group: In the control group the camera will be held and maneuvered by a human~     assistant. The procedures will be performed according to the hospital and OR routine~     procedure. The surgical team will consist of 2 assistants and a surgeon. One of the~     assistants (OR-nurse, intern or resident) will hold the laparoscope and maneuver it. Posture~     of the surgeon and the assistant that maneuvers the laparoscope will be recorded during~     standardized predefined steps of the procedure.~      Main study parameters/endpoints:~      - RULA score, measured during predefined steps of the procedures.~      Secondary parameters/endpoints:~      - Questionnaires: Subjective Mental Effort Questionnaire (SMEQ), Local Experienced Discomfort~     (LED) scale (before and after the operation), NASA Task Load Index (NASA TLX).~   "
17344|NCT03339947|"~     Since it is not routine practice in France to raise public awareness about the risk of~     acquiring multidrug resistant Enterobacteriaceae (MRE) during international travel, the~     investigators aimed to determine, among French travelers attending a consultation for travel~     medicine, patients level of knowledge about the risk of acquiring MRE.~   "
17345|NCT03339934|"~     The optimal dose and fractionation regimen for whole breast irradiation, whole breast and~     regional nodal irradiation, and postmastectomy radiotherapy remains unknown. The goal of this~     phase II randomized controlled trial is to determine whether the hypofractionated proton~     regimens proposed are non-inferior compared with standard fractionated proton radiotherapy~     and therefore worthy of further investigation.~   "
17346|NCT03339921|"~     We will investigate the feasibility of a simple outpatient one time injection regimen for the~     treatment of Chronic Exertional Compartment Syndrome (CECS). We think botulinum toxin~     injections will be a potentially cost-effective, low-risk alternative to surgery in reducing~     pain and returning patients to full activity.~   "
17347|NCT03339908|"~     Multiple sclerosis, chronic inflammatory disease of the central nervous system, affects~     approximately 100,000 peoples in France. It is the leading cause of disability in young~     adults. Tremor is a common symptom (25-58% of patients depending on the series) and can be~     particularly disabling. The drug treatments against tremor are ineffective or insufficient.~     Deep brain stimulation of the Vim (Small nucleus within thalamus) and stereotactic~     radiofrequency thalamotomy have shown their efficacy in this indication. However, in some~     cases these invasive procedures are impossible because of operational risk. Gamma knife~     thalamotomy can be an alternative choice. This procedure, less invasive, mainly because of~     the absence of craniotomy is used by several teams of international reputation for over~     fifteen years, with good to excellent results in essential tremor. The team of Marseille,~     which has an experience of 22 years in Gamma Knife radiosurgery has treated 250 patients with~     severe tremor (essential tremor or Parkinson's disease) by a unilateral thalamotomy with an~     improvement of 70% of functional scores.~      In the literature, no formal studies of the effect of Gamma Knife in Multiple Sclerosis (MS)~     tremor is reported. There are only a few cases without specific evaluation of the efficacy in~     this disease. Hence the importance of studying in detail the effects of this technique, which~     allows a precise and limited lesion volume. Using an isocenter of 4mm and a dose of 130 Gy~     radiation lesion obtained is limited to a volume of 200 to 500 mm3.~      The aim of this study is to assess through a minimally invasive technique with a~     circumscribed and reproducible lesion volume, the effect of thalamotomy on the particular~     tremor in multiple sclerosis with a prospective evaluation of its effects.~      Patients with MS with a disabling tremor will be included in the study. They will be assessed~     with neurological examination, quality of life scales, neuropsychological assessment,~     functional scores and cerebral MRI.~      This study will demonstrate the feasibility and effectiveness of Gamma Knife thalamotomy in~     MS patients with severe tremor.~   "
17348|NCT03339895|"~     The first objective of this study was to compare the traditional fluid management (TFM) with~     PVI guided goal-directed fluid management (GDFM) in terms of controlled intraoperative fluid~     volume, surgical end-point fluid balance, blood lactate and serum creatinine levels. ASA I-II~     70 patients included in this prospective study.~   "
17349|NCT03339882|"~     LHRH-a is an important hormone treatment in breast cancer especially in high-risk hormone~     receptor-positive patients or hormone receptor-negative but needing ovarian function~     protecting. The climacteric symptoms caused by LHRH-a are often and prominent, which is a~     common clinical problem.~   "
25236|NCT03236675|"~     Demonstrate feasibility of detection of EML4-ALK fusion transcripts and T790M EGFR mutation~     from exosomes in the circulation of Non-Small Cell Lung Cancer (NSCLS) patients.~   "
17351|NCT03339856|"~     Selective retina therapy (SRT) selectively disrupts the retinal pigment epithelium (RPE) with~     minimal damage to the photoreceptors. Previous studies have shown SRT to be effective for~     resolving SRF, while causing only minimal collateral damage to the retina and vision.However,~     most patients included in prior studies had chronic CSC (≥3 months symptom duration) and SRT~     efficacy on acute CSC is not fully known.~      The current study evaluated short-term treatment outcomes following SRT with real-time~     feedback-controlled dosimetry in Korean patients with acute idiopathic CSC.~   "
17352|NCT03339843|"~     Open-label, phase II, basket trial. This trial is a screening program for abemaciclib~     efficacy in multiple platinum-resistant tumour types by using metabolic imaging (PERCIST) and~     RECIST v1.1 criteria.~      Based on the rate of FDG-avidity and the absence of deactivation of the Rb gene function in~     more than 95% of cases, we propose to define 5 tumour types of interest in a preliminary~     stage:~        1. Platinum-refractory esophageal adenocarcinoma (ADC)~        2. Platinum-refractory esophageal squamous cell carcinoma (SCC)~        3. Platinum-refractory cholangiocarcinoma~        4. Platinum-refractory and progressive after immunotherapy urothelial cancer~        5. Platinum-refractory endometrial cancer~   "
17353|NCT03339830|"~     IO-SMA-Registry is a prospective, longitudinal and observational study which objective is to~     collect prospectively information on longevity, psychomotor development and respiratory~     function of patients with infantile-onset spinal muscular atrophy.~   "
17354|NCT03339817|"~     The purpose of this study is to describe respiratory disorders in patients with severe~     multiple sclerosis (EDSS from 6.5).~   "
17355|NCT03339804|"~     The purpose of the present study was to test the hypothesis that doxorubicin and~     cyclophosphamide adjuvant chemotherapy (CHT) acutely induces neurovascular and hemodynamic~     changes in patients with breast cancer. To test this hypothesis, women with breast cancer~     (stage II-III) underwent two experimental sessions, saline (SL) and CHT. In the CHT session,~     doxorubicin (60 mg/m2) and cyclophosphamide (600mg/m2) were administred in 45 min. In the SL~     session, a matching saline volume to that of the CHT session was infused over 45 min.~   "
17356|NCT03339791|"~     The aim of the study is to compare two different bariatric procedures performed in patients~     with 65 years or more: gastric bypass and sleeve gastrectomy. Primary outcomes will be weight~     loss, control of comorbidities and morbidity of the operation. Secondary outcomes are related~     to functionality, that will be evaluated with specific tests.~   "
17357|NCT03339778|"~     Patients with primary immunodeficiency disorders (PID) on intravenous immunoglobulin (IVIG)~     treatment may experience adverse events (AEs). Patients who experience AEs on any 10% IVIG~     solution will be changed to octagam 5% for six infusions to evaluate the potential benefit~     for reduction of AEs on a lower concentration IVIG product.~   "
17358|NCT03339765|"~     Self-advocacy, defined as the ability of a patient to get her needs and priorities met in the~     face of a challenge, is an essential skill but not all women with advanced cancer are able to~     do it. We want to instruct women with advanced cancer who have low self-advocacy to~     self-advocate for their health and well-being. We will test a new serious game or video~     program that teaches self-advocacy skills through interactive, situation-based activities.~     The goal of the Strong Together serious game is to engage participants in challenges commonly~     experienced by women with advanced cancer, offer them choices to self-advocate or not, and~     directly show them the health and social benefits of self-advocating and the negative~     consequences of not self-advocating. Through engaging in the Strong Together program,~     participants vicariously learn the essential skills of self-advocacy, understand the~     downstream effects of using or not using these skills, and learn distinct behaviors that they~     can then use to address their own challenges.~   "
17359|NCT03339752|"~     A study in healthy male subjects to investigate whether administration of ACT-541468 can~     affect the fate in the body (amount and time of presence in the blood) of rosuvastatin~   "
17360|NCT03339739|"~     The effectiveness of mandibular exercises as a treatment of muscular Orofacial Pain is yet~     unknown. This study hypothesized that training exercises can be an effective therapy~     improving pain perception.~   "
17361|NCT03339726|"~     This will be a randomized, double-blind, placebo controlled, parallel-group Phase 2 study to~     evaluate the efficacy of a new formulation of phenylephrine HCl and a currently marketed~     phenylephrine HCl for relief of nasal congestion in subjects with naturally occurring cold~     symptoms.~   "
17362|NCT03339713|"~     The purpose of this study is to demonstrate the non-inferiority of the concomitant~     administration of an adenovirus serotype 26- based vaccine encoding for the respiratory~     syncytial virus pre-fusion F protein (Ad26.RSV.preF) and seasonal influenza vaccine versus~     the administration of seasonal influenza vaccine alone in terms of humoral immune response~     expressed by the geometric mean titers (GMTs) of hemagglutination inhibition (HI) antibody~     titers against all four influenza vaccine strains 28 days after the administration of~     influenza vaccine, and to assess the safety and tolerability of a single dose of 1*10^11~     viral particles (vp) of Ad26.RSV.preF, administered intramuscularly to participants aged~     greater than or equal to 60 years separately or concomitantly with seasonal influenza~     vaccine.~   "
17363|NCT03339700|"~     The main purpose of the project is to evaluate the disease free survival and overall survival~     in patients diagnosed with acute lymphoblastic leukemia undergoing allogeneic hematopoietic~     stem cell transplantation (allo-HSCT) adding gemcitabine to our standard conditioning regimen~     based on two alkylating drugs (reduced BUCY 2).~   "
17364|NCT03339687|"~     Brief Interventions (BI) based on Motivational Interviewing are effective to reduce alcohol~     use. In this study the investigators test the hypothesis that that an open Mindset increases~     the positive effects of BI.~      Patients who are newly admitted to the psychotherapy outpatient clinic are routinely screened~     for risky alcohol use. All patients with risky alcohol use are eligible to the study and all~     receive the WHO's ASSIST-linked BI.~      Participants receive a brief Mindset induction prior to receiving BI. They are are randomly~     assigned to either the induction of an open or a closed Mindset according to Gollwitzer.~      The investigators measure the change in alcohol-related risk perception, treatment motivation~     and real alcohol drinking.~   "
17702|NCT03335254|"~     This will be a phase 1/2a, open-label, single-center study with 3 periods. The aims of the~     study are to:~        1. evaluate the dose-response curve following ascending single doses of TSX-011;~        2. confirm optimum dosing conditions;~        3. evaluate the efficacy of single or multiple daily adaptive dosing; and~        4. evaluate the safety and tolerability of TSX-011.~   "
17365|NCT03339674|"~     Based on previous research (Odenwald & Semrau, 2012) the investigators know that~     psychoeducation on comorbid mental disorders during residential alcohol detoxification can~     improve subsequent treatment utilization. In this study they will study a hypothesized~     psychological mechanism that contributes to this behavior change.~      The investigators will recruit alcohol dependent patients in residential detox treatment who~     all receive Treatment as Usual. Participants will be randomly assigned to an additional~     psychoeducational group therapy (intervention group) or to an additional neuropsychological~     group training (control group). Measurements will take place on the day before study~     inclusion, one week later and one month after release from index residential treatment.~     Measurements will include alcohol-related risk perception, alcohol use, treatment motivation,~     comorbid psychiatric symptoms and whether the patient has regularly completed treatment and~     whether he/she has been transferred to subsequent treatment. Furthermore, six months after~     release from index treatment information on re-admission to the clinic is assessed from~     patient files.~      The investigators hypothesize that the behavioral effects of psychoeducational group~     intervention will be mediated by adaptive changes of the individual's alcohol-related risk~     perception.~   "
17366|NCT03339661|"~     In kidney transplant patients, CMV infection remains the leading infectious cause of~     morbidity and mortality. Clinical and virological relapses are common and are involved in~     chronic graft dysfunction. To date, it is not certain that secondary prophylaxis allows~     reducing these relapses, although this prophylaxis is part of the current recommendations.~     Our team has recently shown that the expansion of γδ T cells in peripheral blood during CMV~     infection was correlated with the absence of virological and clinical relapses. Indeed, the~     absence of relapse was associated in 94.7% of cases with the presence of γδ T cells expansion~     while relapses occurred in about 90% of cases in the absence of γδ T cells expansion. These~     results suggest that the indication and duration of secondary prophylaxis after the curative~     treatment of CMV infection in kidney transplantation could be guided by the immune~     surveillance of γδ T cells.~   "
17367|NCT03339648|"~     The University of Florida's (UF) Lastinger Center for Learning, in partnership with the UF~     Psychology Department, have been funded by the National Institute of Justice to advance the~     skills of School Resource Officers (SROs) currently working in the Miami-Dade Schools Police~     Department through an innovative, scalable, online and in-person professional development~     system. The goal will be realized through a 36-month pilot project allowing for the~     development, testing, and refinement of the system conducted in partnership with the~     Miami-Dade County Public Schools, and includes an evaluation component to assess for efficacy~     and scalability.~   "
17368|NCT03339635|"~     To assess the effects of testosterone replacement therapy on fat mass and other components of~     the metabolic syndrome. A randomized double-blind placebo controlled intervention study,~     followed by an open-label treatment phase. Results of this pilot study will be used to design~     a multicenter randomized controlled study in a large group of TC survivors~   "
17369|NCT03339622|"~     Cancer causes pain in many of the patients that it affects. Physicians specialized in~     palliative care help advanced cancer patients to maintain as good pain control as possible~     through the use of medications such as opioids. Even with palliative care and optimal use of~     medications, many patients still suffer enormously as the cancer spreads. Because of this,~     some cancer patients also try or use cannabis in different ways to relieve their pain and~     improve the way they feel. However, there has not been much high-quality research done yet to~     prove whether or not cannabis products are truly useful to relieve severe cancer pain. This~     study is to test if advanced cancer patients who use inhaled medical cannabis (PPP001), in~     addition to palliative care management, will experience improvement in quality of life and~     relieve uncontrolled pain, providing safety conditions.~   "
17370|NCT03339609|"~     Nowadays there is a growing interest towards non-invasive assessment of urinary dysfunctions~     in clinical practice. The tendency to use uroflowmetry as a first-line screening tool is~     based on the inexpensiveness, time efficiency, comfort of the patient, etc. However, it is~     stated that uroflowmetry as a stand-alone study lacks the potential to make an accurate~     diagnosis. In regard to this, the International Continence Society indicated that the~     addition of pelvic floor electromyography might increase the accuracy of this assessment.~     Despite this recommendation, uroflowmetry in combination with electromyography has not been~     conducted in a healthy population.~      The initial objective of this study was to examine whether adding electromyography to~     standard uroflowmetry in a healthy paediatric population would change the representation of~     parameters, especially of voiding patterns. In addition, the influence of several factors on~     uroflow parameters was analysed to complement current literature.~   "
17371|NCT03339596|"~     EPO-T aims to investigate (i) whether short-term add-on treatment with erythropoietin (EPO)~     can reduce cognitive side-effects of ECT and (ii) whether such effects are long-lasting.~     Further, structural and functional magnetic resonance imaging (MRI) will be used to explore~     the neural underpinnings of such beneficial effects of EPO. Finally, the trial examines~     whether potential protective effects of EPO on cognition are accompanied by changes in~     markers of oxidative stress, inflammation, and neuroplasticity.~      It is hypothesized that EPO treatment will (i) counteract ECT-induced cognitive decline,~     accompanied by (ii) increased sub-regional hippocampal volume, (iii) greater memory-related~     hippocampal activation and reinforcement of dorsolateral prefrontal activity during memory~     encoding and working memory, and (iv) changes in peripheral markers of inflammation,~     oxidative stress and neuroplasticity. Furthermore, we hypothesize that add-on EPO-treatment~     will produce greater, more sustained mood improvement than ECT treatment alone.~   "
17386|NCT03339401|"~     This study is designed to assess the safety, overall tolerability, and antiviral activity of~     short course BCV therapy, as compared with current standard of care (SoC), for the~     treatment of adenovirus (AdV) infections in high-risk (i.e., T cell depleted) pediatric~     allogeneic hematopoietic cell transplant (HCT) recipients. A virologic response-driven~     approach to the duration of treatment will be evaluated, in which subjects randomized to BCV~     therapy are treated until AdV viremia is confirmed as undetectable or until a maximum of 16~     weeks of therapy, whichever occurs first.~   "
17387|NCT03339375|"~     Prospective randomized clinical trial Compare the goal-directed fluid therapy using~     esophageal Doppler and classic fluid therapy~   "
17372|NCT03339583|"~     Background: Importance of chronic insomnia (CI) problem is determined by its high prevalence~     rate, comorbidity and resistance to the treatment. Although cognitive behavior treatment of~     insomnia (CBT-I) remains the recommended treatment for CI it has disadvantages of time~     consuming and low treatment response. Hence shortened and simplified behavioral approaches~     such as Brief Behavioral therapy of insomnia (BBT-I) are developed. The aim of the present~     study is to test the effectiveness of BBT-I program for chronic insomnia in comparison with~     zopiclone in Russian population. The anthropometric, psychological and polysomnographic~     characteristics of patients were measured to find predictors of effectiveness of each method.~      Participants: 42 adults (14 males, 28 females, mean age 54 years) meeting the criteria for CI~     according International classification of sleep disorders-3 Methods: Participants were~     randomized into two groups. Each group passed 2-week courses of treatment by brief behavior~     treatment of insomnia (BBT-I) and zopiclone in different orders with 2-week washout period~     between the courses. Participants underwent in-lab polysomnography prior to the treatment and~     completed questionnaires (Insomnia Severity Index (ISI), Dysfunctional beliefs about sleep~     scale (DBAS), Beck Depression Inventory (BDI) and others) in the beginning and the end of~     each course~   "
17373|NCT03339570|"~     Prospective non-randomized, open, unicentric clinical trial to compare two different~     treatments for Three-four parts fractures of proximal humerus (Neer's Classification) in~     elderly patients(over 75 years old). Both technics are: Sling inmobilization and shoulder~     arthroplasty.~   "
17374|NCT03339557|"~     The present randomized controlled trial is designed to compare one novel total knee~     replacement (TKR) design and two conventional TKR designs in terms of functional outcome. 80~     patients will be randomized in each of the three arms (240 altogether).~   "
17375|NCT03339544|"~     Assessing the efficacy of Celebrex premedication on pain during and after endodontic~     treatment in teeth with symptomatic irreversible pulpits~   "
17376|NCT03339531|"~     Prostate cancer (CAP) is one of the most common malignancies in men, both in Western~     countries and developing countries. Radiation therapy (RT) is an important therapeutic~     option. New technologies (3D, IMRT, IGRT, VMAT) have been introduced in the last decades,~     with a progressive improvement of clinical outcome. However, in many countries the only~     treatment option is the traditional 2D technique based on standard simulation. The~     indications for field definition in this treatment are still based on expert's opinions. The~     aim of this analysis is to propose new indications for 2D fields definition based on~     three-dimensional simulation in a population of patients with CAP. Twenty patients with CAP~     consecutively treated with RT in our center were identified. Patients underwent CT-simulation~     in supine position. Pelvic MRI images were fused with CT-simulation images. In this way,~     delineation of the prostate and seminal vesicles was performed on MRI images. Clinical Target~     Volume definition (CTV) was performed according to EORTC guidelines simulating 4 different~     categories: low-risk CAP, intermediate-risk CAP, high-risk CAP without involvement of the~     seminal vesicles, and high-risk CAP with involvement of seminal vesicles. The Planning Target~     Volume (PTV) was defined by adding a margin of 10 mm to the CTV in all directions. For each~     patient, 8 treatment plans were calculated. In particular, for each of the 4 categories of~     risk, 2 treatment plans were calculated by using a cobalt source or 10 MV photons. Treatment~     plans were calculated using the box technique. Progressive optimization was realized with an~     iterative procedure by evaluating the three-dimensional dose distribution. Once the final~     plan was achieved (respecting the PTV constraint: D98 > 95%), distances of the fields edges~     from a set of reference points were measured.~   "
17377|NCT03339518|"~     The number of breast cancer survivors is growing. Women with a personal history of breast~     cancer worry about their risk of getting cancer again. The current study will develop~     counseling about breast cancer recurrence risk and will also get an estimate of the~     preliminary impact of this counseling. The goal is to enable women to make better decisions~     about their treatment.~   "
17378|NCT03339505|"~     Treatment of increased ICP, using Anti-secretory Factor, in patients with severe head trauma~     Brain edema, defined as an increased fluid content in either the extracellular or~     intracellular space, arise in both trauma and in conjunction with other brain pathologies~     such as infectious diseases, intracranial tumors and ischemic events, i.e. stroke. The~     mechanisms underlying the formation of edema are not fully understood. In the injured brain,~     leakage over the blood brain-barrier arise which leads to transport of fluid from the blood~     to the extracellular space, causing an extracellular or vasogenic edema. Damage to cell~     membranes and disruption of cell function causes an intracellular or cytotoxic edema.~     Although one type of edema may predominate initially, one type most likely leads to another.~     In addition to the physiological, flow-related changes that arise, the edema is also worsened~     by the inflammatory response to damage. In the injured brain, disease associated molecular~     patterns (DAMP), and pro-inflammatory cytokines that can give rise to both intracellular and~     extracellular edema are released.~      If the edema becomes expansive enough to give rise to a significant increase in intracranial~     pressure the circulation of the brain is threatened and surgical intervention inevitable. The~     most common procedure is hemicraniectomy, a procedure intended to add more space for the~     edematous brain to expand. The procedure itself is risky, and re-operations due to hematoma,~     CSF-leakage and more are common. Furthermore, it is not known how the procedure itself~     affects the brain in terms of increased edema, tearing of the brain etc.~      Antisecretory factor, AF is a 41 kDa protein that exists in most mammals. It was first~     discovered due to its ability to inhibit experimental diarrhea. Endogenous AF secretion~     increases after exposure to bacterial toxins and an increase in AF secretion in combination~     with an inflammatory reaction may be a part of normal defense against the secretory and~     inflammatory component in diarrhea and other pathological processes involving membrane~     leakage and inflammation. AF has been shown to modulate pro-inflammatory and anti-~     inflammatory cytokine release. AF has also been shown to be effective against vertigo~     symptoms in Meniere's disease, which is believed to be caused by an abnormal collection of~     lymph around the balance nerve. AF and AF16 (the functional terminal 16 amino-acid peptide)~     have been tested in animal models of cerebral edema such as herpes encephalitis and traumatic~     brain injury with significant reduction of intracranial pressure, morbidity and mortality AF~     is commercially available for human use as Salovum®, an egg yolk powder B221® enriched for~     AF. It is available in pharmacies without prescription, but can also be prescribed as a~     dietary supplement in Sweden. Salovum® is classified as a medical food by the Swedish~     Pharmaceutical Agency and the European Union. Salovum® is currently registered in the~     Republic of South Africa.~      Hypothesis Cerebral edema in traumatic brain injury is caused by inflammation triggered by~     tissue damage. The anti-secretory and anti-inflammatory compound Salovum® has the potential~     to counteract this and thus reduce cerebral edema in traumatic brain injury. Furthermore, the~     reduction of cerebral edema is hypothesized to decrease intracranial pressure, reduce the~     development of secondary brain damage and subsequently reduce treatment intensity levels and~     death.~      Aims and Objectives Though, the number of patients with severe traumatic head injury in~     Sweden is decreasing and the need for a larger, randomized trial in a centre with large~     volumes of traumatic brain injury is needed The primary focus for scientific investigation is~     to evaluate if AF given as a dietary supplement (Salovum®) will reduce 30-day mortality in~     adult patients with severe traumatic brain injury. The secondary aims are to investigate~     whether AF will reduce intracranial pressure and treatment intensity levels - TIL, during~     intervention.~      Methodology The outlined study is a phase-2, prospective, double-blinded, randomized,~     placebo-controlled trial. After inclusion patients will be randomized to active Salovum® or~     placebo egg powder treatment every 4th hour during 5 days. Treatment of patients will be~     according to current algorithms at the study site.~      Study population 100 adult (age 18+) patients with severe traumatic brain injury, where~     ICP-monitoring is deemed necessary, will be included in the study.~      Patient samples A venous whole blood sample will be drawn before and after treatment in all~     patients. The blood sample will be frozen and stored at the study site for further analysis.~      Anticipated benefits In an ongoing Swedish study, preliminary results indicate that AF has a~     very potent ICP- lowering effect in patients with severe TBI and other pathologies~     encompassing cerebral edema, which might prove an effect on 30-day mortality in this trial.~   "
17379|NCT03339492|"~     The primary objective of this study is to prospectively determine, at 12 months post-surgical~     repair of full thickness rotator cuff tears, the safety and efficacy of treating full~     thickness rotator cuff repairs with pulsed electromagnetic fields (PEMF). The hypothesis~     states that exposure to a pulsed electromagnetic field (PEMF) following surgical repair of a~     full thickness rotator cuff tendon tear reduces tendon re-tear rates. The strength of the~     shoulder muscles and the levels of pain in subjects after surgical repair of their rotator~     cuff adjunctively treated with an active PEMF device will also be measured.~   "
17380|NCT03339479|"~     Patients with lung nodules/mass found by CT (computed tomography) or PET (positron emission~     tomography) who agree to receive lung resection are arranged to test the dielectric property~     before receiving the frozen pathological examination. And the final pathological results are~     recognized as the standard diagnosis. Then the sensitivity and specificity of the dielectric~     property test will be evaluated comparing with the frozen pathological examination.~   "
17381|NCT03339466|"~     Individuals who have undergone the Fontan procedure are uniquely dependent upon respiratory~     mechanics to support pulmonary blood flow (PBF). The investigators hypothesized that enhanced~     respiratory muscle function via inspiratory muscle training (IMT) would improve performance~     on cardiopulmonary exercise stress testing (CPET).~   "
17382|NCT03339453|"~     The purpose of this study is to compare a needle-free treatment of hypoglycemia with glucagon~     nasal powder (study drug) to a marketed glucagon administered by the intra-muscular (IM)~     route, in participants with type 1 diabetes mellitus (T1DM).~   "
17383|NCT03339440|"~     The investigators propose a randomized controlled effectiveness trial to evaluate the~     integrated clinic-community model of child obesity treatment as compared with routine primary~     care.~   "
17384|NCT03339427|"~     This is a 9 months, randomized, single center, open-label, parallel-group study to compare~     the efficacy and safety parameters of vitamin D supplementation in vitamin D deficiency~     subjects in China.~   "
17385|NCT03339414|"~     Collect the blood sample per-operation experience deep hypothermia cardiac arrest for aorta~     artery replacement surgery Collect the blood from the CPB machine and from intravenous~     injection tube which already set at different time point.~   "
17703|NCT03335241|"~     The purpose of the study is to evaluate the efficacy and toxicity of fludarabine with~     pegylated liposomal doxorubicin versus pegylated liposomal doxorubicin alone in patients with~     platinum resistant or refractory ovarian cancer.~   "
17388|NCT03339362|"~     Lumbar facet-joints are small, paired joints in the low back that provide stability,~     integrity and flexibility of movement to the spine. Diseased facet-joints may cause~     persistent low back pain, with significant socioeconomic impact. At present, there is~     insufficient high quality evidence to support the use of lumbar facet-joint injections (FJIs)~     in treating low back pain of less than 12 months' duration; the National Institute for Health~     and Care Excellence (NICE) therefore did not approved their use in their 2009 publication.~      This study will investigate the feasibility of conducting a larger, definitive trial to~     assess lumbar FJIs (a needle is inserted into the facet-joint and steroid injected), by~     comparing it to a dummy or 'sham' procedure (a needle is inserted near the facet-joint but no~     therapeutic substance injected).~      Patients with persistent low back pain, referred to a community or hospital-based pain,~     spinal or musculoskeletal clinic by their general practitioner, will be reviewed and assessed~     by a specialist physician. They will be screened and recruited based on clinical history and~     examination. Participants will receive diagnostic injections (medial branch nerve blocks);~     those with a positive response will randomly receive either FJIs or a sham procedure, under~     x-ray guidance. All participants will receive a combined physical and psychological programme~     recommended by NICE as a strategy to reduce pain and its impact on the person's day-to-day~     life, even if the pain cannot be cured completely.~      Participants will be asked to complete questionnaires comparing a range of pain and~     disability-related issues. These will occur at baseline (before treatment) and at 6 weeks, 3~     months and 6 months after their injections.~      Criteria for the study to be considered successful (and a definitive trial feasible) include~     the abilities to standardise the methods for injection and to recruit and retain sufficient~     participants, and the acceptability of the study design to participants and clinicians.~   "
17389|NCT03339349|"~     The rates of Venous thromboembolism (VTE) after orthopedic surgery are as high as 40-60%~     without prophylactic measures. Enoxaparin, a low-molecular-weight heparin, produces an~     anticoagulant effect by binding antithrombin, thereby accelerating antithrombin's~     inactivation of coagulation factor Xa (FXa), thus decreasing the likelihood of clot~     formation. Despite standard dosing enoxaparin prophylaxis, VTE rates in post-operative~     orthopedic trauma patients remain as high as 12.2%.The investigators will examine enoxaparin~     pharmacokinetics and test whether a clinical protocol for real-time enoxaparin dose~     adjustment can favorably alter the proportion of patients with in-range anti-Factor Xa (aFXa)~     levels. Outcomes will include peak and trough steady-state aFXa levels in response to~     standard and escalated doses of enoxaparin and the incidence of venous thromboembolism and~     bleeding events post-surgery. In the trauma and orthopaedic populations, patients with low~     initial aFXa levels are significantly more likely to develop deep venous thrombosis. Thus,~     this study has important implications for appropriate enoxaparin dose magnitude and~     frequency, and may ultimately help to decrease the substantial morbidity and mortality~     associated with post-operative VTE.~   "
17390|NCT03339336|"~     The primary objective of this study is to evaluate the efficacy of BIIB074 in treating pain~     experienced by participants with confirmed small fibre neuropathy (SFN) that is idiopathic or~     associated with diabetes mellitus. The secondary objectives of this study are to evaluate the~     effect on worst pain, neuropathic pain quality, sleep interference due to pain, patient~     global impression, use of supplemental pain medication, and SFN symptoms in participants~     treated with BIIB074; to investigate the safety and tolerability of BIIB074 in participants~     with SFN; and to characterize the pharmacokinetics (PK) of BIIB074 in participants with SFN.~   "
17391|NCT03339323|"~     Background:~      Total knee arthroplasty (TKA) is one of the most common operations in orthopedics. After~     surgery, the decline of bone mineral density and muscle mass was proved, oral bisphosphonate~     is commonly used to prevent BMD loss in clinic treatment, however, the loss of muscle mass~     can only be maintained with exercise intervention. The goals of TKA rehabilitation should be~     based on control pain, improve ambulation, maximize the range of motion, develop muscle~     strength, and provide emotional support. We planned to find out a potential adjuvant~     effective option in muscle mass for the management of post-TKA. Literature suggested that~     exercise training has been found to have the considerable effect on TKA. However, no suitable~     exercise prescription was established on the scientific basis. The current study aimed to~     find out a potential treatment mode.~      Study Rationale:~      This project will be performed for consecutive three years, the patients with post-TKA~     patients are managed with the treadmill exercise training in the first year. In the second~     year, resistance exercise is prescribed. In the third year, eccentric exercise plus~     resistance training will be arranged in the exercise group. We will analyze the data of the~     three years and cross-comparative analysis. A prescription of exercise training, a period of~     24 weeks each year, 3 times a week, for each 10 minutes warm-up, 40 minutes exercise~     training, and 10-minute cool down for exercise prescription~      Study Objectives:~      To investigate the effect of long-term exercise training, eccentric and resistance exercise~     on muscle mass in patients with total knee arthroplasty. To monitor the performance index~     included: physiological indices, muscle mass, ambulation and the quality of life index.~      Study Design Duration of Treatment: Total of 6-month exercise intervention in each year. The~     number of Planned Patients: 35 subjects in each control and exercise group in one year, the~     total of 210 subjects in three years.~      Investigational Product: Automated biochemistry analyzer, Biospace Inbody 7.20 Analysis of~     body composition instrumentation; Dual Energy X-ray Absorptiometer (DEXA), isokinetic muscle~     strength measurement, VICON to analysis ambulation, functional fitness, the questionnaire~     including SF-36, KOOS and VAS pain score.~      Endpoints: Data collection in pre-surgery, 3 months, 6 months, 9 months and 12 months after~     surgery.~   "
17392|NCT03339310|"~     This is a multicenter, prospective, single-arm study of the Optimizer Smart System with~     2-leads~   "
17393|NCT03339297|"~     This is a study comparing the defibrotide prophylaxis arm vs standard of care arm for the~     prevention of aGvHD.~   "
17394|NCT03339284|"~     There are ca 900 new cases of kidney cancer in Finland/year. The curative therapy for kidney~     cancer is partial or total nephrectomy depending on the localization and the size of tumor.~     Main of these operations are laparoscopic.~      Epidural analgesia is considered as most effective for the treatment of postoperative pain~     after open nephrectomy, but after laparoscopic operation parenteral and enteral opioids~     combined with paracetamol (acetaminophen) usually offer adequate postoperative pain relief.~     However, the need for opioids postoperatively may be high and side effects, such as sedation~     and nausea, are common. On the other hand epidural analgesia has some contraindications and~     risks for serious complications. Nevertheless, inadequately treated acute postoperative pain~     is considered as one of the main risk factors for persistent postoperative pain.~      Recently quadratus lumborum block (QLB) has gained popularity in the treatment of~     postoperative pain after various surgeries in the area from hip to mamilla. It is more~     beneficial than other peripheral blocks, since it covers also the visceral nerves. A single~     shot QLB has reported to last up to 48 hours.~      Perineural dexamethasone added to local anesthetic has been reported to prolong the duration~     of analgesia of the perineural nerve block, but it's effect on the duration of QLB is not~     known.~      90 kidney cancer patients with planned laparoscopic nephrectomy aging 18-85 will be recruited~     based on a power calculation. The primary outcome measure is the postoperative cumulative~     opioid consumption. Secondary outcomes are acute pain (NRS scale), nausea, vomiting,~     mobilisation and long term outcomes such as quality of life and persistent pain.~   "
17395|NCT03339271|"~     The purpose of this study is to evaluate the effect and cost of technology-enhanced~     transitional palliative care on family caregivers who provide care to a loved one at home~     after a hospitalization.~   "
17397|NCT03339245|"~     Non alcoholic fatty liver disease (NAFLD) is the most common cause of abnormal liver function~     tests in the U.S. (Browning, et al., 2004), ranging from steatosis to end-stage liver~     disease. Fructose ingestion by the American public has steadily increased since the 1980's,~     and with it increases in NAFLD, fatty liver hepatitis (NASH), diabetes, obesity, and~     cardiovascular disease. Foods and beverage in the U.S. are typically sweetened with sucrose~     (50% glucose and 50% fructose) or high fructose corn syrup (45-58% glucose and 42-55%~     fructose) (Stanhope, et al., 2009). Research into the role that added fructose plays in the~     emerging chronic health issues is necessary to affect public policy and provide the~     connection between fructose and the increasing incidence of these co-morbidities.~      There is evidence that gut bacteria contribute to a range of human diseases including those~     of the liver and gastrointestinal tract. Dietary fructose has been suggested to play a role~     in the development of these diseases and has been shown to alter gut microbes in animals. If~     the investigators find that dietary fructose alters bacteria in the human gut, this would~     suggest a potential targetable link between high fructose diet and disease.~   "
17398|NCT03339232|"~     The central hypothesis of this study is that BCAA supplementation and BCAA supplementation~     plus low-intensity activity will improve muscle mass and HRQOL in cirrhotic patients compared~     to usual care~   "
17399|NCT03339219|"~     The purpose of this study is to evaluate the efficacy of cabozantinib measured by Independent~     Radiology Committee (IRC)-assessed objective response rate (ORR) in Japanese patients with~     advanced renal cell carcinoma (RCC) that has progressed after prior vascular endothelial~     growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) therapy.~   "
17400|NCT03339206|"~     This study will assess the impact of cigarette constituent messages with and without FDA~     source and quit information in a randomized controlled trial. The investigators hypothesize~     that cigarette constituent messages will increase intention to quit compared to messages~     about littering cigarettes (the control). The investigators also hypothesize that constituent~     messages that include FDA source and quit information will increase intention to quit~     compared to messages without that information.~   "
17401|NCT03339193|"~     This study is a single-centre prospective post-market approval of the early experience with~     the Watchman FLX device for left atrial appendage closure in patients with atrial~     fibrillation at high risk of thromboembolic stroke and with contraindications to long-term~     oral antocoagulation therapy.~   "
17402|NCT03339180|"~     This study investigate the prevalence of elevated biomarkers of cardiac injury in patients~     with suspected influenza infection and the prognostic implication on the composite endpoint~     of death of any cause, hospitalization due to myocardial infarction, unstable angina, heart~     failure and stroke.~   "
17403|NCT03339167|"~     Protein is the key determinant of growth and bodily functions. The quality of food proteins~     depend on their amino acid content and the amount of amino acids used by the body to make~     proteins. Globally Cereal Grains (CG) provide 50% of the calories and protein in the diet and~     exceed 80% in poorer developing countries. In many of those countries, millet is the major~     cereal grain in the diet. The protein in millet is low in the essential amino acid lysine.~     Hence millet protein is of low quality. Low lysine affects protein synthesis in the body.~     Cooking methods also affect the lysine available from foods to the body.The protein can be~     complemented by the addition of lentils to augment the low lysine content. However, lentils~     are prohibitively expensive in some developing countries.~      As the human population increases, the world faces the continuous challenge of maximizing a~     limited food supply. Protein quality (PQ) evaluation of millet directly in humans would allow~     us to bridge the gap in knowledge between what is required and how best to provide.The~     information gathered from this project will provide the first direct experimental data on PQ~     of millet protein in humans on which nutrition recommendations can be built.~   "
17404|NCT03339154|"~     The research study is being done so we can determine the quality of the protein present in~     Canadian chickpeas. Amino acids are the building blocks of protein and protein quality is~     determined by the amount of amino acids present and by their bioavailability (their~     absorption and use by the body). Some amino acids are essential which means they must be~     obtained from the diet. If any one of the essential amino acids is missing in the diet, the~     body cannot make proteins that are used to repair tissue build bone, teeth, etc…Chickpeas as~     a food source contain low amounts of the essential amino acid methionine which makes its~     protein incomplete. The amino acids in chickpeas are also affected by cooking. Our objective~     is to determine the amount of methionine in chickpeas that the body can use. We will test~     chickpeas by studying them after cooking them, on their own and by combining the chickpeas~     with rice in a mixed meal to make a more complete protein.~      This research is being done in order to bridge the gap between knowledge of protein~     requirement and the amount of food needed to meet that requirement. Results from this study~     will be important for recommendations guiding food choices of chickpeas as a major protein~     source in the diet.~      Previously the quality of dietary protein for human consumption was studied in animals. This~     study is being done in humans because studies in animals are not directly applicable to~     humans. Excessive animal protein consumption is also linked to cardiovascular disease. Plant~     protein sources like chickpeas are important alternatives shown to enhance ecosystem~     resilience, and improve human health.~   "
17405|NCT03339141|"~     Tracheal intubation, particularly before surgery, is traditionally done in supine position.~     It was shown in the general population and in obese patients in particular, that the~     pre-oxygenation in a 25° head-up position provided a better efficiency of the pre-oxygenation~     and an apnea time longer. This position would also allow for better intubation conditions in~     direct laryngoscopy.~      The investigators intend to assess two different patient's intubation position : supine~     position and 25° head-up position~   "
17406|NCT03339128|"~     The primary objectives of this study are to explore the therapeutic effect of eluxadoline in~     treating IBS-D in pediatric patients 12-17 years of age, to evaluate the pharmacokinetics of~     eluxadoline in pediatric patients with IBS-D, and to evaluate the safety and tolerability of~     eluxadoline in pediatric patients with IBS-D.~   "
17407|NCT03339115|"~     This study is to evaluate the safety of the Cardiovalve System with its associated procedure,~     and observe the device performance in reducing mitral regurgitation. Data collected in this~     clinical study will include 30-day safety and performance of the device and delivery system,~     and long-term clinical outcomes over a follow-up of 2 years.~   "
17410|NCT03339076|"~     The Catheter Science M3 Mini Catheter has been developed for management of urinary~     retention. This temporary device allows for normal functioning of the external striated~     sphincter. The design contributes to its atraumatic insertion and removal. It is a short~     catheter segment which is attached to a monofilament suture which runs thru the lumen of the~     urethra and is attached to a small plastic bobber. This study is designed to validate the~     reduction in these adverse effects: The suture to the outside allows for repositioning should~     the device slip back into the bladder and facilitates removal. With volitional voiding and~     competent external sphincter, patients are able to void spontaneously without the need of a~     collection device and are continent. The design enhances the flow characteristics and reduces~     post void residual. Since the M3 does not have a tubular segment thru the tip of the penis or~     sphincter, biofilm production is eliminated.~   "
17411|NCT03339063|"~     The Italian registry of pulmonary non-tuberculous mycobacteria (NTM) -IRENE- is an~     observational, multicenter, prospective, cohort study enrolling consecutive adult patients~     with either a NTM respiratory infection or NTM-Pulmonary Disease. The coordinating center is~     located at the Pulmonary Department of the Fondazione IRCCS Ca' Granda, Ospedale Maggiore~     Policlinico, Milan, Italy. So far, more than 35 centers, including mainly pulmonary and~     infectious disease departments, joined the registry. The registry has been developed to~     accept an unlimited number of patients and no deadlines have been decided.~   "
17412|NCT03339050|"~     Diseases such as hypertension and stroke affect mid-life and older African Americans at~     higher rates than Whites, negatively affecting health status of this group. This project~     determine the effectiveness of a faith-based health intervention for mid-life and older~     African Americans using community-based participatory research approaches.~   "
17413|NCT03339037|"~     Due its high incidence, mTBI and its consequences of PPCS are a major public health issue.~     There is no consensus regarding the treatment of PPCS in pediatrics. Relying on its results~     in adults, HBOT offers a promising new direction of treatment, which targets the basic~     pathological processes responsible for post-concussion symptoms.~      The effect of hyperbaric oxygen therapy in pediatric TBI has never been evaluated.~      The aim of the current study is to evaluate in a prospective cross-over, randomized study,~     the effect of HBOT on children with PPCS due to mild TBI.~   "
17414|NCT03339024|"~     This study is an assessment of the long-term effect of oxytocin nasal spray on alcohol~     withdrawal and dependence in adults admitted for detoxification of alcohol after 60 days and~     1 year. It is a follow-up study of a placebo-controlled randomized controlled study where~     subjects used oxytocin nasal spray during acute withdrawal and the following 4 weeks in an~     outpatient setting. Half of the participants have received oxytocin nasal spray, the other~     half placebo nasal spray (NCT02903251).~   "
17415|NCT03339011|"~     Physical inactivity is a major risk behaviour with a potential for causing premature death,~     particularly among people with mobility limitations, such as knee osteoarthritis.~      Digital motivational interventions (such as SMS) can motive to a healthy behaviour including~     increased physical activity.~      The purpose of this study is to investigate if motivational text messages following an~     exercise intervention to improve mobility limitations will change the physical activity level~     in patients with knee osteoarthritis.~      This study is designed as pilot randomized controlled trial, with equal randomization (1:1).~     Eligible participants will be randomised into one of two groups (intervention or control)~     after completing their baseline measurements. The intervention group will receive weekly~     motivational text messages and the control group will not receive any attention from the~     study.~   "
17416|NCT03338998|"~     This is a randomized, placebo-controlled, subject- and investigator-blinded trial of BAF312~     in intracerebral hemorrhage (ICH) patients to study efficacy, safety, and tolerability.~     BAF312 is a drug that could potentially limit brain inflammation after ICH, and thereby~     improve neurological outcome for hemorrhagic stroke patients.~      In this study, ICH patients meeting study criteria will be randomized at 1:1 ratio into~     either active or placebo group. The first i.v. treatment must starts within 24 hours of ICH~     event. Participating patients will also be followed up for additional 76 days after treatment~     on neurological and safety conditions in 3 clinic visits.~      BAF312 treatment includes the following identified risks: transient effects on heart rate and~     rhythm (bradyarrhythmia and 2nd degree AV block) at treatment initiation that are completely~     avoided by initial up-titration; liver enzyme elevation; lymphopenia due to lymphocyte~     redistribution (expected effect of BAF312); macular edema; and varicella zoster (VZV)~     infection.~   "
17417|NCT03338985|"~     Several molecular studies showed chromosomal alterations in patients with endometrial cancer,~     with gains in 1q, 19p, 19q, 8q, 10q and 10p and loss of 4q, 16q and 18q. Several genes of~     interest have been identified (P53, PTEN, PIK3CA, ß-catenin, K-ras ...).~      A study has already been carried out at the Reims University Hospital with inclusion of~     patients with endometrial cancer and patients with endometrial hyperplasia. It identified~     specific alterations of nosologic continuum of pathology and characterize areas of interest~     on the genome.~   "
17418|NCT03338972|"~     This phase I trial studies the side effects and best dose of BCMA CAR-T cells in treating~     patients with BCMA positive multiple myeloma that has come back or does not respond to~     treatment. T cells are a type of white blood cell and a major component of the immune system.~     T-cells that have been genetically modified in the laboratory express BCMA and may kill~     cancer cells with the protein BCMA on their surface. Giving chemotherapy before BCMA CAR-T~     cells may reduce the amount of disease and to cause a low lymphocyte (white blood cell) count~     in the blood, which may help the infused BCMA CAR-T cells survive and expand.~   "
17419|NCT03338959|"~     This pilot phase I/II trials studies pembrolizumab and radiation therapy in treating patients~     with intermediate or high-grade soft tissue sarcoma. Monoclonal antibodies, such as~     pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Radiation~     therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving pembrolizumab~     and radiation therapy may work better in treating patients with soft tissue sarcoma.~   "
17551|NCT03337230|"~     The purpose of this study is to see if it is practical to use social media-based and~     traditional online weight loss intervention components among low socioeconomic status~     participants using the Facebook social media (SM) and Fitbit self-monitoring platforms. Also,~     the study will test the effectiveness of recruiting participants via social media and at~     community events and locations. The results of this study will be used to inform future~     research studies.~   "
17420|NCT03338946|"~     The purpose of this study is to evaluate the use of remote interrogation (readers) of CIEDs~     in evaluation of suspected TIA/stroke patients, HF or those experiencing syncope. This~     approach has the potential to advance the practice of CIED evaluation by staff without~     specialized training in cardiac electrophysiology (non-EP staff). We hypothesize that~     actionable events will be identified with use of CIED readers. These events may include~     identification of atrial fibrillation in TIA/stroke patients, percentage biventricular pacing~     in patients with HF or evaluation of arrhythmic events in syncope patients. We believe that~     non-EP staff will find CIED readers easy or very easy to use and that time from transmission~     to analysis for non-EP trained staff will be low.~   "
17421|NCT03338933|"~     This proposal addresses the critical absence of information about the neurobiology of~     recovery from Alcohol Use Disorder (AUD) in alcohol and nicotine users. AUD and nicotine use~     disorder (NUD) are the most commonly abused (non-prescription) substances in the U.S.~     Co-addiction is particularly high in military veterans. Although nationwide estimates peg the~     rate of AUD/NUD co-addiction at 80%, the Substance Abuse Treatment Program (SATP) at the~     Veterans Affairs Portland Health Care System (VAPORHCS) finds that 90% of veterans treated~     for AUD also meet criteria for NUD. The investigators hypothesize that a support vector~     machine learning algorithm will be able to use the measures to classify subjects as AUD, NUD~     both or neither and that the algorithm will predict outcome (sobriety or relapse) at three~     months.~   "
17422|NCT03338920|"~     This study will be conducted to evaluate the safety and efficacy of sumatriptan nasal powder~     (AVP-825) compared to placebo in the acute treatment of migraine in adolescent participants,~     12 through 17 years of age.~   "
17423|NCT03338907|"~     Several projects in high altitude research in environments with a low oxygen partial pressure~     (hypobaric hypoxia) leading to hypoxemia showed, that cerebral perfusion and cerebral~     performance could be improved by adding C02 (cabon dioxide).~      The investigators hypothesize that adding 5% C02 to 02 (Oxygen) also under normobaric~     conditions increases the time until a significant cerebral hyopxia is measured by near~     infrared spectroscopy (NIRS) compared to the administration of 95% 02.~      lf this hypothesis proves to be true, this approach might be used in situations in which~     individuals are prone to cerebral hypoxia. In bariatric surgery, patients that experience an~     apnea phase are more prone to (cerebral) hypoxia due to the fact, that they have a higher~     body mass index (BMI) leading to a reduced functional residual capacity (FRC), which serves~     as the oxygen reserve in the body.~   "
17424|NCT03338894|"~     IBD adds additional stressors as a chronic disease that has unpredictable and sometimes~     embarrassing symptoms to the normal challenges that teenagers face. Stress and how stressful~     events are perceived, may contribute to worsening of disease. Complementary and alternative~     medicine (CAM), are used often by pediatric IBD patients and maybe beneficial in decreasing~     stress and improving quality of life. Yoga could be a well suited paring with standard~     medical therapy to decrease and provide a better sense of control and improve quality of~     life.~   "
17425|NCT03338881|"~     The purpose of this study is to assess the mass balance and to characterize the~     pharmacokinetics (PK) in plasma and urine, and of total radioactivity in plasma and whole~     blood following a single oral dose of [14C]-TAK-659 solution containing 60 to 80 micro curie~     (Ci) of total radioactivity in participants with advanced solid tumors and/or lymphomas.~   "
17426|NCT03338868|"~     The purpose of this study was to investigate the serum concentrations, physical and~     psychological well-being characteristics in patients having chronic musculoskeletal pain with~     metabolic syndrome, and to compare patients without metabolic syndrome.~   "
17427|NCT03338855|"~     The purpose of this study is to investigate the effects of 5 weeks treatment with~     dapagliflozin in type 2 diabetes patients on how the hormone insulin acts on sugar uptake in~     muscles.~   "
17428|NCT03338842|"~     Patients with limb amputations experience the sensation of the missing extremity, which is~     sometimes coupled with a persistent and debilitating pain in the missing limb, a condition~     known as phantom limb pain (PLP). This study will test the use of virtual reality (VR)~     training as a possible treatment of PLP.~   "
17429|NCT03338829|"~     Diabetes in pregnancy carries significant pregnancy specific risks and requires frequent~     glucose monitoring to reduce these risks. This project compares the effect of two incentive~     schemes on adherence rates of glucose testing in pregnancy.~   "
17430|NCT03338816|"~     The purpose of this study is to evaluate the effect of subcutaneous givosiran (ALN-AS1),~     compared to placebo, on the rate of porphyria attacks in patients with Acute Hepatic~     Porphyrias (AHP).~   "
17431|NCT03338803|"~     A non-interventional cohort study using existing data from patients in the Optum Clinical~     Database which contains electronic health record (EHR) data from providers across the United~     States to determine whether there is comparable effectiveness of linagliptin on glycemic~     effectivenes~   "
17432|NCT03338790|"~     The purpose of this study is to determine which combination of Nivolumab plus either~     Rucaparib, Docetaxel, or Enzalutamide is the most effective in treating Castration-resistant~     Prostate Cancer that has spread~   "
17433|NCT03338777|"~     Safety evaluation of combined immunogene therapy in patients with advanced melanoma.~   "
17434|NCT03338764|"~     The purpose of this study is to assess the efficacy and pattern of use of the combination~     drug product SM-1 in adults who sometimes have difficulty in falling asleep or staying~     asleep, but who do not have chronic insomnia. Participants will receive SM-1 or placebo to~     take at home as needed over the course of 3 months treatment period.~   "
17435|NCT03338751|"~     The purpose of the study is to see if a commercially available hearing assistance device~     called the PockeTalker has an effect on performance on cognitive (memory and thinking) tests~     among skilled nursing facility residents.~      Investigators are asking residents to perform cognitive tests with and without hearing~     assistance equipment known as PockeTalkers. This study will be conducted at one urban Skilled~     Nursing Facility (SNF) with the goal of understanding the extent to which hearing impairment~     impacts commonly used cognitive impairment measures for clinical assessment. Cognitive~     performance will be measured, cerumen occlusion, and perceived hearing.~   "
17561|NCT03337100|"~     In the setting of naloxone standing orders, this study will assess if co-dispensing naloxone~     with opioids to patients prescribed chronic opioid therapy changes opioid risk behaviors,~     increases naloxone uptake, and increases knowledge about overdose and naloxone.~   "
17436|NCT03338738|"~     Among the enterobacteria , the production of ESBL(extended-spectrum beta-lactamases) is the~     first cause of multi-resistance.~      Also the infections due to these EBSL are increasing ; it is therefore necessary to evaluate~     the impact of different antibiotics on the healthy tract flora modification and on the faecal~     abundance due to ESBL.~      The study has for main objective to estimate in vivo the impact of the various beta one -~     lactamines on the relative faecal abundance enterobacteria producers of EBLS in ICU patients~     presenting a rectal colonization known in enterobacteria ESBL.~   "
17437|NCT03338725|"~     Medication errors are considered by WHO to be a subject that requires attention at all levels~     of care, in order to reduce the serious and preventable damage related to medication.~      These strategies are aimed at the patient's safety policy. In Colombia, at the regulatory~     level there is no standardized clinical pharmacy model where the role of the clinical~     pharmacist is described extensively and in detail, and in addition, data are unknown of the~     scope or direct effect of the incorporation of this model in the assistance in the results of~     health care.~      The Hospital Pablo Tobón Uribe, it is a highly complex institution in Medellin (Colombia),~     certified by Join Comission International (JCI), which requires the continuous interaction of~     the pharmacist in patient care, in order to avoid medication errors and contribute to patient~     safety indicators. In this sense, the hospital structured and implemented a clinical pharmacy~     model that establishes the activities of the pharmacist incorporated into the care team in~     the patient attention. Today this model is applied in the institution, however, it is~     necessary to know the effect of its application in the solution of drug-related problems~     (DRPs) or a negative outcome related to medicine. The objective of this study is to know the~     effect on patient safety of a clinical pharmacy model in a hospital of high complexity and~     framed in the WHO initiative to reduce these errors of medication.~   "
17438|NCT03338712|"~     Recurrence free survival The patients will be followed in regular time intervals in~     accordance with the EAU-Guidelines (2010) and the S-3 Guideline for Prostate cancer of the~     German Urological Association. Data will be updated once yearly for until death.~   "
17439|NCT03338699|"~     The study will evaluate the safety and acceptability of the topical anesthesia-based, no-flip~     ShangRing technique vs. Mogen clamp for Early Infant Male Circumcision (EIMC) in neonates and~     infants up to 60 days of life.~      The study will consist of 2 phases; a pilot phase and a field study. In the pilot phase, male~     infants of up to 60 days of life will be enrolled in three sub-Saharan countries,~     specifically Kenya, Tanzania, and Uganda. Infants will be randomized in 1:1 fashion to~     undergo EIMC using either the Mogen clamp or no-flip ShangRing technique using topical~     anesthesia. Upon completion of the pilot trial and assuming satisfactory safety results, a~     larger non-comparative field study of ShangRing EIMC will be initiated, as performed by~     non-physician providers in routine practice settings in the three sub-Saharan African~     countries.~      Total study duration will be 3 years. The pilot phase is anticipated to encompass a total of~     1 year. Completion of the field study is expected to take 2 years.~      Study Endpoints include:~        1. To compare the rates of adverse events (AEs) with the ShangRing or Mogen clamp~        2. To compare pain control, time to complete wound healing and parent satisfaction with~          EIMC using the ShangRing or Mogen clamp~        3. To compare operative time and provider preference.~        4. To assess the rate of spontaneous ring detachment with the ShangRing as a method to~          decrease the need for follow-up visits after circumcision.~        5. To assess the subpreputial microbiome of the infants prior to and after the initiation~          of circumcision~      Three correlative studies will be conducted:~        1. Penile microbiome study: In the pilot trial, the subpreputial microbiome of the infants~          undergoing circumcision will be assessed to better understand the spectrum of bacteria~          that may exist and play a role in infant circumcision.~        2. Demand creation study: During both the pilot phase and the field study, it will be~          assessed whether device-driven EIMC can be safely and effectively integrated into~          maternal and child health services as a method to promote demand creation.~        3. Cost impact study: During both the pilot phase and the field study, a comparative cost~          analysis of EIMC with ShangRing versus Mogen clamp will be performed, in addition to a~          cost analysis of ShangRing EIMC as performed in routine clinical settings in the field~          study. The costing of demand creation will also be assessed.~   "
17440|NCT03338686|"~     This study will compare two commonly used soft tissue grafting techniques (free gingival~     graft, FGG vs. connective tissue graft, CTG) to augment the soft tissue around dental~     implants with a lack of keratinized mucosa.~      To investigators knowledge, these 2 types of grafts have not been compared for differences in~     clinical (amount of KM increase, tissue thickness increase and esthetics) and~     patient-centered outcomes (pain, swelling, change in daily activities) in a controlled study.~   "
17441|NCT03338673|"~     People with serious mental illness often report difficulties with thinking skills like~     memory. These difficulties can make it harder to perform day-to-day activities. The purpose~     of this study is to test whether combining a type of non-invasive brain stimulation with~     computerized cognitive exercises is acceptable to participants, and whether it is helpful in~     improving a specific type of memory skill in people who have mental health conditions and~     memory deficits.~      This study is designed so that all participants will get both treatments: the non-invasive~     brain stimulation and computerized cognitive exercises. Half of the participants will start~     with both the brain stimulation and the cognitive exercises (dual therapy), and half will~     start with just the computerized exercises (monotherapy). After three weeks, participants~     will switch to the other condition: the people who did both treatments first will switch to~     just the cognitive exercises alone, and the people who started with the cognitive exercises~     alone will then switch to doing both the brain stimulation and cognitive exercises.~      Overall, participants will be in the study for about 7-8 weeks. The brain stimulation~     treatment involves 10 visits to the clinic over 3 weeks. The computerized cognitive exercises~     can be done at home, and involve 10 hours of exercises over 3 weeks. Participants will also~     complete paper-and-pencil assessments at the beginning, middle, and end of treatment.~   "
17442|NCT03338660|"~     Platelet function will be tested in individuals on antiplatelet medications to determine the~     optimal storage methodology.~   "
17443|NCT03338647|"~     Randomized study of stereotactic body radiation therapyRANDOMIZED STUDY OF STER (SBRT) versus~     transarterial chemoembolization (TACE) in locally advanced hepatocellular carcinoma.~   "
17444|NCT03338634|"~     This is a single, un-replicated visit to the Children's Metabolic Kitchen and Eating Behavior~     Lab designed to gather data on children's responses to images used in MRI studies.~     Additionally, a demographic questionnaire for parents will be piloted.~   "
17445|NCT03338621|"~     To evaluate the efficacy, safety and tolerability at 8 weeks (2-months), 52 weeks~     (12-months), and 104 Weeks (24-months) post the start of the following treatment regimens in~     participants with: Drug Sensitive TB (DS-TB) patients given BPaMZ for 17 Weeks ( or 4 months)~     vs. Standard HRZE/HR treatment given for 26 weeks (or 6 months) and Drug Resistant TB (DR-TB)~     patients given BPaMZ for 26 Weeks (or 6 months)~   "
17574|NCT03336918|"~     Lithium is highly effective in the treatment of bipolar disorder. This study aims to~     investigate, for the first time, the impact of lithium monotherapy on the structural and~     functional connectivity of the brain using MRI imaging.~   "
17446|NCT03338608|"~     The anterior cervical fusion and decompression (ACDF) surgery provides direct access to~     symptomatic areas of the cervical spine. Cosmesis, including factors like wound healing, is~     an important issue for patients who undergo surgery on anterior neck structures. One~     significant factor that impacts cosmetic healing in patients who undergo the ACDF surgery is~     whether a vertical or transverse incision of the platysma muscle in the neck was used to~     access the cervical spine.~      The purpose of the present study is to compare cosmetic outcomes in vertical versus~     transverse platysmal incisions for anterior cervical spine exposures. Researchers intend to~     analyze this effect with a prospective comparative study model. A targeted number of 100~     patients who undergo anterior cervical surgery, as part of their standard of care, will be~     randomized to receive either a transverse or vertical platysmal incision during the exposure~     part of their procedure. Informed consent for inclusion in the study, as approved by the~     Institutional Review Board, will be obtained from all patients in addition to consent for the~     surgical procedure. Regardless of the platysmal incision, all patients will receive a~     standard transverse skin incision, as is done routinely in anterior cervical exposures. After~     the surgery, all closures will be done in a standard manner.~      These patients will be followed up in the clinic at two weeks, three months, six months, and~     one year. They will be evaluated for wound healing and incision cosmesis using a modification~     of The Hollander Wound Evaluation Scale. Clinical photographs of the patients' necks will be~     captured during these visits in a manner that does not reveal any patient identifiers in any~     way. The incisions and overall cosmesis will be graded using the scale mentioned above. The~     data will be analyzed to determine if a transverse platysmal incision offers better cosmetic~     results than a vertical platysmal incision, or vice versa, and will also be used to validate~     the modified wound evaluation scale.~   "
17447|NCT03338595|"~     This project is an attempt to understand how Orkambi treatment affects exercise capacity and~     the function of the arteries in CF patients who are homozygous F508del. Our goal is to~     perform the exercise and vascular measurements every 3 months after a patient starts taking~     Orkambi.~   "
17448|NCT03338582|"~     The investigators propose to carry out an observational study of patients implanted with a~     pacemaker using AAI SafeR® mode after a TAVI procedure. This study aims to define the~     persistence or not of high-grade AVB beyond seven days after the procedure, based on the~     analysis of PM memories, and define definitive cardiac pacing indications after TAVI~     procedure.~   "
17449|NCT03338569|"~     This is a randomized, double-blind, placebo-controlled clinical trial to compare Vitamin C~     versus placebo for patients presenting to the ICU with a diagnosis of septic shock.~   "
17450|NCT03338556|"~     A study to examine the duration of effect of PrEP-001 in healthy subjects challenged with~     HRV-16~   "
17451|NCT03338543|"~     This study evaluates the effect of percutaneous electrical nerve stimulation (PENS) and~     transcutaneous nerve stimulation (TENS) for pain relieving in patients with liver cancer.~     Patients will randomly allocated into PENS group, Tens group and control group.~   "
17452|NCT03338530|"~     This study was a 4-year efficacy trial (cluster randomized trial) of a comprehensive~     school-based intervention (CSBI) for high-functioning elementary students with autism~     spectrum disorder (HFASD). The sample included children, in grades 1-5 with HFASD enrolled in~     public schools. School buildings were randomly assigned to either receive the CSBI or serve~     as the control comparison (business-as-usual [BAU]). School staff in the CSBI schools~     administered social skills groups (60-90 minutes per week), facial-emotion recognition~     computer instruction (60 minutes per week), therapeutic activities (40-60 minutes per week),~     a behavioral reinforcement system (across the school day), and parent training (60-90 minutes~     per month) during the school year. Children with HFASD in the BAU schools received their~     typical educational program. Implementation fidelity was assessed by research assistants~     throughout the school year in the CSBI schools using standardized fidelity monitoring sheets.~     The fidelity monitoring sheets were also completed by research assistants during observations~     in the BAU schools in order to identify the possible presence of any of the treatment~     elements in the control (BAU) schools. Outcome measures were completed for both groups at~     baseline (6 weeks into the school year prior to the initiation of the intervention) and at~     the end of the school year following completion of the intervention. Primary outcome measures~     included a test of emotion recognition and parent-teacher ratings of ASD symptoms and~     secondary measures included parent-teacher ratings of social/social-communication skills, a~     test of academic achievement skills, and a direct behavioral measure of social interaction~     skills (child testing and behavioral observations were completed by evaluators blinded to~     treatment condition; parent-teacher raters were not blinded to treatment condition). For the~     primary measures/analyses, it was hypothesized that students with HFASD who complete the CSBI~     will demonstrate significantly greater emotion-recognition skills and receive significantly~     lower parent-teacher ratings of ASD symptoms compared to controls. For the secondary~     measures/analyses, it was hypothesized that students with HFASD who complete the CSBI will~     receive significantly higher parent-teacher ratings of social/social-communication skills,~     demonstrate significantly higher academic skills, and exhibit significantly higher rates of~     social interactions with peers compared to controls.~   "
17453|NCT03338517|"~     Background: Diabetic patients are frequently showed with foot ulceration as a common~     complication which increases to 20% in admission. Low-level laser therapy is used to control~     foot ulcer, but there is very limited data to compare the effects of Helium-Neon Laser~     therapy (HNLT) and Infrared Laser therapy (ILT) on diabetic foot ulcer.~      Objectives: This study aimed to compare the effects of (HNLT) and (ILT) on diabetic foot~     ulcer.~      Methods: Sixty-five patients with diabetic foot ulcer (51 males and 14 females) aged~     50-60years. The participants were classified randomly to two groups, Helium-Neon Laser~     therapy (HNLT) and Infrared Laser therapy (ILT) groups. HNLT group received medical treatment~     with Helium-Neon Laser therapy and ILT group received medical treatment with Infrared Laser~     therapy for 8 weeks. Ulcer surface area was assessed using a sheet of cellophane paper at the~     beginning of the study, after four weeks, and after eight weeks at the end of the study.~   "
17454|NCT03338504|"~     Myocardial injury is common in patients without acute coronary syndrome, and therefore~     international guidelines propose a classification of patients with myocardial infarction by~     aetiology. This differentiates between myocardial infarction due to plaque rupture (type 1)~     and myocardial oxygen supply-demand imbalance (type 2) in other acute illnesses. However,~     these guidelines have not been widely adopted as the diagnostic criteria for type 2~     myocardial infarction are not clearly defined. Patients with type 2 myocardial infarction~     have poor long term outcomes, with at least twice the mortality at five years compared to~     those with an index type 1 myocardial infarction. Despite the majority of deaths being~     attributable to non-cardiovascular events, the rate of future type 1 myocardial infarction or~     cardiovascular death is similar regardless of index classification. If this future risk is~     related to the presence of underlying coronary artery disease, then there may be the~     potential to improve outcomes through targeted investigation and secondary prevention. The~     investigators will undertake a systematic evaluation of the mechanism of myocardial injury~     and the role of coronary artery disease in 100 patients with elevated cardiac troponin~     concentrations where the diagnosis is likely to be type 2 myocardial infarction. These~     studies will help improve the assessment of patients with myocardial injury, refine the~     diagnostic criteria for type 2 myocardial infarction, and aid the design of future~     therapeutic trials.~   "
17506|NCT03337828|"~     This a controlled, double-blind, randomized, cross designed study to determine the effect of~     an alcohol-free beer with low glycemic index carbohydrates (isomaltulose) and a resistant~     maltodextrin, comparing to an alcohol-free beer with regular composition, on glycemic~     metabolism (glucose, glycated hemoglobin, insulin and HOMA index) in subjects with recently~     diagnosed diabetes mellitus and overweight or obesity. 44 subjects were randomized to consume~     for 10 weeks: a) two alcohol-free beers with regular carbohydrates composition per day; b)~     two alcohol-free beers with modified carbohydrates composition per day. Those subjects~     randomized to begin with A beer during 10 weeks will change to B beer during the second phase~     for 10 weeks and vice versa. There is a 4-8 weeks wash-out period between two phases.~   "
17455|NCT03338491|"~     Brief Interventions (BI) based on Motivational Interviewing are effective to reduce alcohol~     use. In this study the investigators test the hypothesis that that an open Mindset increases~     the positive effects of BI.~      University students take part in a voluntary screened for risky alcohol use. All students~     with risky alcohol use are eligible to the study and all receive the WHO's ASSIST-linked BI.~      Participants receive a brief Mindset induction prior to receiving BI. They are are randomly~     assigned to either the induction of an open or a closed mindset according to the Mindset~     theory of action phases (Gollwitzer & Keller (2016). Mindset Theory. In: V. Zeigler-Hill,~     T.K. Shackelford (eds.), Encyclopedia of Personality and Individual Differences. New York:~     Springer).~      The investigators measure the change in alcohol-related risk perception, treatment motivation~     and real alcohol drinking after the Brief Intervention in relation to the mindset induced~     before receiving the intervention.~   "
17456|NCT03338478|"~     Patients with epilepsy exercise less than the general population. A barrier to exercise may~     be the effect of antiepileptic drugs on balance and reaction time. This proposal endeavors to~     study the effect of two common antiepileptic drugs (levetiracetam and lamotrigine) on balance~     and reaction time using a Wii balance board and reaction time test. This will be tested at~     descending doses in an epilepsy monitoring unit. Drug levels will be monitored, as well as~     center of pressure, and reaction time.~   "
17457|NCT03338465|"~     Greater trochanteric pain syndrome (GTPS) is characterized by pain over the greater~     trochanter, which can refer down the lateral aspect of the hip. Historically, conservative~     treatments such as rest/activity modification, anti-inflammatory medication, physiotherapy~     and local corticosteroid injection, are employed as first-line management, with some~     refractory cases requiring surgical intervention.~      Acknowledging the unpredictable response and frequent recurrences associated with traditional~     non operative treatment, the risks and prolonged rehabilitation associated with surgery, and~     the favorable results from prior studies involving radial pressure waves as a treatment for~     GTPS, the aim of this study is to investigate the dose-related effect of focalized shockwave~     treatment at different total energy influx in patients with chronic GTPS.~   "
17458|NCT03338452|"~     The study evaluates the timeline of changes of body composition, physical and psychological~     performance, and biochemical markers of metabolism and inflammation responses to low energy~     ketogenic diet for loosing weight in obese individuals. The participants will be monitored~     and guided by the interdisciplinary obesity team for 12 weeks.~   "
17459|NCT03338439|"~     The aim of this study was to evaluate if the positive effects recorded on glycemic control~     with CSII were maintained on the long term compared to multi-daily injections (MDI). The~     secondary objective was to evaluate if there is a reduction of type and number of~     cardiovascular events (CV) in CSII group compared to MDI group after 8 years of observation.~     This retrospective, observational trial evaluated 104 diabetic patients with prior treatment~     with MDI initiating CSII therapy compared to 109 diabetic patients continuing MDI.~   "
17460|NCT03338426|"~     The objective of this clinical study is to evaluate the efficacy and safety by comparing the~     fimasartan/atorvastatin treatment group to the fimasartan/placebo treatment group and the~     placebo/atorvastatin treatment group respectively at Week 8 in patients with essential~     hypertension and dyslipidemia.~   "
17461|NCT03338413|"~     Depression is a highly prevalent and debilitating mental disorder, ranked one of the leading~     causes of disability worldwide. Several studies have identified neuropsychological deficits~     in populations of depressed patients affecting domains including attention, memory and~     executive functioning. These deficits often persist even in patients whose depressive~     symptoms have remitted. Cognitive impairment in depression represent a core feature of~     depression, and a valuable target for intervention. Identification of methods that would lead~     to amelioration would be of great clinical interest, and cognitive rehabilitation (CR) could~     be a potential way of achieving this. To date few studies on cognitive rehabilitation in~     depression has been conducted, but the preliminary results are promising. Still the~     demonstration of long-term effects and evidence relating to improved daily life executive~     functioning (i.e., generalization) is lacking. In the present study different group-based~     cognitive rehabilitation interventions will be compared. The aim of the study is to~     investigate if a group-based brain training intervention can improve executive function in~     patients with active and remitted depression. Efficacy will be assessed immediately after~     intervention, but also six months after the intervention.~   "
17462|NCT03338400|"~     To the investigators knowledge there are no studies in the literature evaluating the effect~     of Dexamethasone administration on patients undergoing outpatient vaginal prolapse surgeries.~   "
17463|NCT03338387|"~     This study evaluates the addition of Acipimox or placebo to exercise on growth hormone~     release and ghrelin secretion in bulimic patients and in healthy women. Two groups of~     participants will receive Acipimox together with exercise versus identical placebo with~     exercise.~   "
17464|NCT03338374|"~     Half of patients with heart failure have normal heart pumping function (Heart failure with~     Preserved Ejection Fraction, HFpEF), most commonly characterised by breathlessness on~     exercise. A number of mechanisms are responsible, but frequently patients are unable to raise~     their heart rate on exercise. This can be treated by a 'rate-responsive pacemaker' (RRP),~     which detects exercise and increases the heart rate accordingly. Some beneficial effects on~     echocardiographic parameters have been reported with exercise programmes. However, evidence~     based treatment options are limited in this group and therapy mainly relies on water tablets~     and treatment of blood pressure.~      Cardiac resynchronisation therapy (CRT) is a technique using specialised 'biventricular'~     pacemakers that is well established in heart failure with reduced pump function. Patients who~     respond to this treatment have lower risk of death and hospitalisation and usually feel~     better. CRT is not currently used in HFpEF. The PROSPECT trial showed that some patients with~     relatively preserved heart function exhibited similar benefits to those with poor pump~     function, but this has not been formally tested. CRT aims to make the heart beat in a more~     synchronised way. Patients with HFpEF commonly have evidence of reduced heart~     synchronisation.~      The investigators plan to assess the feasibility of using a prospective cohort study to~     assess the incremental benefit of CRT over and above RRP in patients with HFpEF. 10 patients~     with HFpEF and insufficient heart rate will be recruited and will undergo exercise testing,~     heart scanning and symptom questionnaires. A biventricular pacemaker will be implanted and~     programmed to RRP for 12 weeks before repeating the tests. After this, the investigators will~     non-invasively programme the pacemaker to CRT for 12 weeks and repeat the functional tests.~     If incremental benefit is shown with CRT the echocardiograms will be analysed in detail to~     determine the mechanism of change. The study participants will be invited to continue their~     involvement in a study extension. This will involve non-invasively programming the pacemakers~     to optimise their function guided by the results of the echocardiograms in the first two~     phases of the study. After a further 12 weeks, the functional assessments will be repeated.~     If no benefit is seen with CRT after initial analysis, the participant involvement will end.~   "
17583|NCT03336801|"~     This study investigates the role of the anesthetic agents propofol and sevoflurane on renal~     function in otherwise healthy patients undergoing basic back surgery.~   "
17465|NCT03338361|"~     The investigators evaluate the efficacy of a computerised program (T.O.P. tool) consisting of~     an approach avoidance training (AAT) (to retrain action tendencies for alcohol-related~     stimuli), a visual probe training (VPT) (to retrain attentional bias for alcohol-related~     stimuli) and the combination of both training procedures versus placebo training, as an~     add-on to treatment as usual (psycho-education and cognitive behavioral therapy).~      The investigators include hospitalized detoxified alcohol-dependent patients, who receive a~     four week training procedure, existing of a pre-assessment, 6 training sessions and a~     post-assessment.~      Outcome measures consist of behavioral measures (consumption of alcohol - self report over 1~     year), questionnaires (AUDIT; craving on 9-point likert scale) and approach avoidance and~     visual probe measurement tasks.~      A six month and 1 year follow-up is included (behavioral measures and AUDIT). Further, the~     investigators will also assess credibility (9-point likert scale) of the training procedure~     before the start of the training and immediately after the assessment of the AAT and VPT~     training.~   "
17466|NCT03338348|"~     The main part of this trial is a phase II study of vosaroxin with azacitidine in older~     patients with newly diagnosed AML and intermediate or adverse genetic risk or MDS-EB-2. An~     initial safety run-in phase of the study will be performed administering the study drug~     vosaroxin with azacitidine in up to 18 patients. After completion of the run-in phase,~     toxicity and response data will be provided to the external Data and Safety Monitoring Board~     (DSMB) and the Trial Committee by the Coordinating Investigator. The Trial Committee will~     decide on the basis of these data and the recommendation of the DSMB on dose modification and~     the vosaroxin dose for the phase II part of the study, which will include 150 patients in~     total.~   "
17467|NCT03338335|"~     this study is an individual patient level meta-analysis of randomized clinical trials, to~     evaluate the influence of ethnicity, to study whether the relative tradeoff between ischemia~     and bleeding is distinct by ethnicity.~   "
17468|NCT03338322|"~     assess the effect of using reciprocating motion with reciproc files versus adaptive motion~     using twisted file adaptive on postoperative pain after instrumentation of necrotic~     mandibular molars.~   "
17469|NCT03338309|"~     The current study sought to evaluate the clinical relevance of iFR-guided strategy in real~     world clinical practice using unrestricted study population from stable angina to acute~     coronary syndrome including acute ST-segment elevation myocardial infarction. Previous~     abundant historical data of FFR-guided strategy will be also included as historical control~     to validate the iFR-guided strategy.~   "
17470|NCT03338296|"~     This study will be conducted to demonstrate weight loss efficacy by change in body mass index~     (BMI) and safety in adolescents age 12 to 17 years (inclusive) during 52 weeks of treatment~     with Belviq XR 20 milligrams (mg) administered once daily (QD) as compared to placebo.~   "
17471|NCT03338283|"~     Objectives: Establishing and validating an electrotherapy procedure with interferential~     current (IFC) application using electro-massage on patients who have undergone acromioplasty~     surgery. To evaluate the possible decrease in pain perception and improvement of~     functionality following surgical intervention.~      Design: Randomized, single blind clinical trial. Subjects: 18-patients, aged 18 to 65, with a~     similar distribution of male and female participants Methods: 10-patients will be enrolled in~     the experimental group and 8 patients as the control group. Both groups of patients will~     undergo six physiotherapy sessions (three times a week). The experimental group will undergo~     a treatment consisting of electro-massage with constant voltage (CV) IFC bipolar application,~     4000 Hz carrier current and 100 Hz amplitude modulated frequency (AMF). Two 48 cm2 electrodes~     will be used. Session length with electrotherapy will be approximately ten minutes.~   "
17472|NCT03338270|"~     This study aims to assess the diagnostic validity of a new minute-MRI sequence for~     neuroradiological evaluation in comparison to conventional MRI.~   "
17473|NCT03338257|"~     Since 1998, UCONN undergraduate students have volunteered as part of a service- learning~     course to deliver a program called Husky Reads. Inspired by the nationally accepted American~     Academy of Pediatrics' program Reach Out and Read, Husky Reads was first designed for~     promotion of health, nutrition habits and literacy by reading health-oriented books to young~     children in pediatric and health clinics. The Husky Reads curriculum now includes a series of~     10 lessons designed to introduce preschool-age children to MyPlate while improving fruit and~     vegetable literacy. Undergraduate students enrolled in the Husky Reads service- learning~     course at UConn or college students participating in the paid summer internship program~     deliver the preschool lessons. Each team of 2-3 undergraduate students is assigned 2-3 early~     care classrooms to visit and deliver Husky Reads lessons to on a weekly basis. This series~     targets children at an early age because early childhood is a pivotal time to influence the~     path towards healthy behaviors and away from obesity. The effectiveness of the Husky Reads~     curriculum on a preschool age child's correct identification and liking of fruits and~     vegetables has not been established. The proposed evaluation uses a pre-test/post- test~     control group design with paired data at the child level to explore whether children who~     participate in Husky Reads have increased odds of correctly identifying the United States~     Department of Agriculture (USDA) MyPlate program (MyPlate) and food group concepts and~     trying or liking select fruits and vegetables.~   "
17474|NCT03338244|"~     In the event that MORDOR (NCT02047981) established the efficacy of oral azithromycin in~     preventing mortality in 1-59 month children, the contingency study was to treat both arms in~     Niger with oral azithromycin (unmasked) for two more years in Niger only.~   "
17507|NCT03337815|"~     Rheumatoid Arthritis (RA) is an autoimmune disease that results in a chronic inflammatory~     disorder that may affect many synovial joints, and may cause serious disability. It has been~     confirmed that Tripterygium Wilfordii has effects of anti-inflammatory, immunosuppressive and~     cartilage protection. This is a multicenter ,double Blind, randomized study to evaluated the~     efficacy and safety of Tripterygium Wilfordii in treating of patients with rheumatoid~     arthritis (RA) and establish a prediction model for Tripterygium Wilfordii response of~     rheumatoid arthritis (RA).~   "
17669|NCT03335683|"~     The aim of the present study was to evaluate the effect of a phytotherapy agent on clinical~     and inflammatory parameters, for the postoperative therapy of the impacted third molar~     surgery. The null hypothesis to invalidate was that, after the last follow-up, there were no~     variations between the phytotherapy agent and the placebo.~   "
17475|NCT03338231|"~     Yellow fever is an acute viral disease transmitted by mosquitoes in South America, Central~     America and Africa. It is more prevalente in males gender and the age above 15 years due to~     the greater exposure in the wild endemic area of yellow fever.~      According to the World Health Organization (WHO), a single dose of the yellow fever vaccine~     is sufficient to maintain protective immunity against yellow fever for a lifetime, therefore~     a booster dose is not required. This issue is difficult to evaluate because there is no~     serological correlate of protection against yellow fever and seropositivity is defined with~     several cut-off points. Although studies indicate that the duration of protection after~     vaccination is long, many studies have demonstrated a reduction of the antibody titrer over~     the years. Consequently, there is more concern about people who live in endemic areas. For~     this reason, Brazil recommends revaccinating once at least until additional studies are~     performed.~      It is important to know the duration of immunity induced by lower doses of YF vaccine. In our~     knowledge, there is a lack of clinical studies evaluating the immunity duration of the yellow~     fever vaccine with lower doses. This information is relevant to subsidize the routine~     recommendation of YF vaccine fractional dose for adults.~   "
17476|NCT03338218|"~     The aim of the study is to investigate the safety of a 6% Hydroxyethylstarch (HES) solution~     (Volulyte 6%) versus an electrolyte solution (Ionolyte) in trauma patients.~   "
17477|NCT03338205|"~     The purpose of this investigation is to perform a pilot study assessing the safety and~     utility of intravenous ketamine as an adjuvant therapy in the emergency department setting~     for pediatric patients in acute status asthmaticus who have failed standard emergency~     therapy.~   "
17478|NCT03338192|"~     It remains unclear whether certain disadvantaged subgroups of society may be at heightened~     risk for poor chronic low back pain (cLBP) outcomes. The overall aim of this study is to~     incorporate a socioeconomic framework to characterize racial differences in cLBP severity and~     disability. Further, guided by the theory of fundamental causes, we aim to examine racial and~     socioeconomic status differences in biopsychosocial predictors of cLBP outcomes, particularly~     endogenous pain modulation.~   "
17479|NCT03338179|"~     The purpose of this study is to determine the respective roles of aging and schizophrenia in~     the regulation of metamemory using a generation strategy. 4 groups will be necessary to~     comparison:~      Adult patients (18-45 years) Adult controls (18-45 years) Aged patients (≥ 59.5 years) Aged~     controls (≥ 59.5 years)~      The effects of age and the disease could lead to interaction in regulating metamemory. The~     effect of age would be aggravated by the disease.~   "
17480|NCT03338166|"~     Hepatocellular carcinoma represents the commonest primary cancer of the liver.serum lactate~     dehydrogenase is an indirect marker of tumor hypoxia,angioneogenesis and worse prognosis.~   "
17481|NCT03338153|"~     the purpose of this study is to determine whether appropriate control of diabetes around the~     PCI time is related with MACE and outcome of diabetic patients.~   "
17482|NCT03338140|"~     evaluation of outcome of living donor renal transplantation in assiut urology and nephrology~     university Hospital regarding the survival of patients and grafts , complications and quality~     of life after transplantation.~   "
17483|NCT03338127|"~     this study to evaluate the frequency of acute kidney injury in critically ill patients in~     intensive care units.~   "
17484|NCT03338114|"~     The FLX-787-106 study will determine how well FLX-787-ODT works to reduce fasciculations in~     patients with Amyotrophic Lateral Sclerosis (ALS). The study will measure how often~     fasciculations occur, and monitor any side effects that might develop while taking the~     investigational product. Participants will be assessed before and after taking a single dose~     of FLX-787-ODT. Approximately 15 people will take part in this study at one center in the~     United States. Participants will be in the study for a single clinic visit and receive a~     telephone call 7 days later to monitor for side effects.~   "
17485|NCT03338101|"~     Comparative study between the Goldmann Flattening Tonometer and the Non-Contact Tonometer in~     patients of a Reference Ophthalmological Hospital~   "
17486|NCT03338088|"~     Evaluation of adherence to clinical treatment of glaucoma in patients of a Reference~     Ophthalmological Hospital in Goiânia using Morisky Adhesion scale as a validated questionary.~   "
17487|NCT03338075|"~     A propensity- matched study was conducted to investigate the feasibility and safety of adding~     temozolomide to hypofractionated stereotactic radiotherapy for large brain metastases.~   "
17488|NCT03338062|"~     The purpose of this study is to compare radiation treatment plans that are designed for~     patients with liver cancer. One treatment plan will be created using routine procedures and~     scans normally performed for radiation treatment planning. The other treatment plan will be~     created using routine procedures with the addition of two imaging scans; a HIDA~     (Hepatobiliary Iminodiacetic Acid) scan and an MRI (Magnetic Resonance Imaging) scan. This~     study will evaluate if adding these imaging scans to treatment planning can reduce the amount~     of radiation to healthy liver tissue during treatment.~   "
17489|NCT03338049|"~     This is a multi-center, non-randomized, single-arm, prospective trial to evaluate a staged~     sampling methodology designed to maximize the diagnostic yield of lung biopsy in a single~     procedure setting.~   "
17490|NCT03338036|"~     Most concussions resolve within 7-10 days, but approximately 40% of individuals do not fully~     recover and suffer from persistent post-concussive symptoms. This 8-week intervention study~     will evaluate the efficacy of heart rate variability (HRV) biofeedback and neurofeedback on~     reducing the number and severity of concussion symptoms.~   "
17491|NCT03338023|"~     The purpose of this study is to compare long-acting basal insulin analog LY2963016 to Lantus®~     in combination with mealtime insulin lispro in adult Chinese participants with Type 1~     Diabetes Mellitus (T1DM).~   "
17492|NCT03338010|"~     The purpose of this study is to compare long-acting basal insulin analog LY2963016 to Lantus®~     in insulin naïve adult Chinese participants with Type 2 Diabetes Mellitus (T2DM) on 2 or more~     oral antihyperglycemic medications (OAMs). Participants will continue their OAMs throughout~     the study.~   "
17524|NCT03337581|"~     1. Acute Hemodynamic and respiratory Changes After Rapid Intravenous different doses of~          Dexmedetomidine in Pediatric.~        2. Pharmacokinetics after a single Rapid Intravenous dose of Dexmedetomidine in Pediatric.~        3. Pharmacokinetics after a single dose of Dexmedetomidine administered as a nasal spray in~          Pediatric.~   "
17493|NCT03337997|"~     The operation to remove certain pancreatic cancers (Whipple procedure), even in 2017, remains~     one of the most complicated surgeries done in the abdomen. It carries a 50% chance of a~     complication, even in the world's largest pancreatic surgery centres.~      Saskatchewan is one of only two centres in Canada to have a promising new technology called~     Irreversible Electroporation (IRE) (NanoKnife®) available to our patients for the ablation~     (destruction) of cancers. IRE is different from other ablation treatments, including heat and~     even radiation, in that with IRE no heat is generated and there is minimal, if any, damage to~     nearby blood vessels, bowel, and ducts. Thus far, IRE has only been used as a last resort~     in cases where the pancreatic cancer cannot be removed with surgery, yet many patients whose~     tumor could likely be removed with a 'Whipple' have expressed a preference to undergo IRE~     instead of the Whipple procedure.~      Our main research questions are: In comparison to Whipple procedure, is IRE an effective~     treatment of pancreatic cancer, and are complications reduced? Is IRE cost-effective? Based~     on the cases we have done and published series of IRE for stage III pancreatic cancer, we~     believe that IRE will be effective and safe in treating lesser stage (I and II) tumors in our~     proposed study.~      This will be a pilot study of 12-15 patients, and all recruited patients will receive the IRE~     treatment and then be followed for up to 5 years for quality of life, recurrence, survival,~     and cost.~   "
17494|NCT03337984|"~     To evaluate the use of damage control surgery by performing bowel resection and laparostomy~     in the treatment of Hinchey III or IV diverticulitis.~   "
17495|NCT03337971|"~     The process of bone remodeling exhibits pronounced diurnal pattern that is important for bone~     health. A balanced rate of bone resorption is required to maintain bone health, a balance~     that can be disturbed during the lifecycle to effect net rate of formation (as occurs during~     growth and development to adulthood) or net resorption (as occurs, for example, during the~     menopause).The research to be undertaken investigates the pluripotent effect of dairy-based~     products on the regulation of the diurnal process of bone metabolism in post-menopausal women~     at risk of osteoporosis.~   "
17496|NCT03337958|"~     Chronic obstructive pulmonary disease (COPD) is a public health problem with great morbidity.~     The main therapeutic strategy is inhalers. The objective of this study is to determine the~     efficacy of an educational intervention in the use of inhalers in patients with COPD~     including ventilatory re-education and video recordings of the patients themselves.~   "
17497|NCT03337945|"~     Subjects will receive the Basel phenotyping cocktail capsule orally with 120-200ml tap~     water in fasted state. After intake peripheral venous blood samples will be drawn.~      12 patients (male and female) with liver cirrhosis for each Child Pugh Category A, B, and C,~     and 12 age- and gender-matched healthy control subjects will be included (in total 48~     participants).~   "
17498|NCT03337932|"~     The purpose of this study is to compare the efficacy of 7-day versus 14-day doxycycline~     treatment in patients with multiple erythema migrans.~   "
17499|NCT03337919|"~     This is a single-arm, phase II, multi-centre study of the safety and efficacy of the PD-1~     inhibitor, nivolumab, as second-line or third-line salvage therapy as a bridge to stem cell~     transplant (SCT) in relapsed/ refractory classical Hodgkin lymphoma patients not achieving a~     complete metabolic response (CMR) on FDG-PET-CT scan after 2 cycles of first or second line~     salvage therapy.~   "
17500|NCT03337906|"~     An observational study of long-term outcomes of HIV-1 infection in persons who become~     infected after enrollment in HIV-1 vaccine trials~   "
17501|NCT03337893|"~     Objective: It is widely accepted that breastfeeding (AS) is superior to other forms of~     nutrition in the first six months of life. Breastmilk contains nutrient items in appropriate~     quantities and a high bioavailability according to the needs of each baby. The United Nations~     Children's Fund (UNICEF) and the World Health Organization (WHO) recommend that babies take~     AS alone and then continue to feed on AS with up to two years of age, with appropriate~     supplementary nutrition, during the first six months of life.~      Even in the hottest climates, breastfeeding babies have been shown to have no additional~     nutrient or fluid requirements for the first six months, including water. In the first 6~     months of breastfeeding with breast milk alone (YAS), the incidence of many diseases,~     especially infectious diseases, decreases and the brain development is better.~      Despite its numerous benefits, mother milk is not utilized in our country sufficiently.~     According to the Turkish Demographic and Health Survey (TNSA), the rate of breastfeeding in~     Turkey was 91.8% in Turkey, while the proportion of babies fed only breast milk in the first~     6 months was 30.1%.~      Infants related deaths, otitis media, lower respiratory tract infections, gastroenteritis,~     obesity were more common in children who were fed formula milk compared to children who were~     fed breast milk during the first year of life. Obesity can reduce insulin resistance and~     hypertension risks later in life.~      According to the research done by Kramer and his colleagues on 13889 children, no effect of~     breastfeeding on physical development, obesity and hypertension was found.~      In this study, whether breast feeding was associated with otitis media in the first year,~     lower respiratory tract infection, gastroenteritis; in the first 5 years of age, obesity and~     hypertension.~   "
17502|NCT03337880|"~     The aim of this study is to compare the impact of instrumental delivery on newborn head mark~     and newborn comfort over the impact of non-instrumental delivery. It is also to evaluate how~     mothers age, Body Mass Index, instrumental extraction indication, extractor type, variety and~     height of the fetal presentation, operator, time of birth (day or night) and birth weight~     impact on head mark existence and newborn comfort.~   "
17503|NCT03337867|"~     The present study aims at investigating the effects of intermittent theta-burst stimulation~     (iTBS) for motor recovery in recurrent stroke patients. Therefore a daily intervention of~     repetitive transcranial magnetic stimulation over 8 days combined with subsequent~     physiotherapy is compared to a control condition, sham stimulation combined with subsequent~     physiotherapy. Motor function, degree of disability and quality of life are examined in order~     to evaluate the effects of iTBS in the rehabilitation of recurrent stroke patients in the~     first weeks and after three months.~   "
17504|NCT03337854|"~     Chronic obstructive pulmonary disease (COPD) is caused by tobacco consumption. The goal is to~     characterize on clinical and radiological data, using computed tomography, this illness in~     order to improve diagnostic and be able to evaluate the prognostic of each patient.~   "
17505|NCT03337841|"~     The aim of this study is to elucidate the utility of the immune checkpoint inhibitor~     pembrolizumab in preventing the recurrence of HCC when administered before and after curative~     surgery or ablation.~   "
17508|NCT03337802|"~     Food allergies (AA) are adverse reactions to food. Over the last decade, the AA scenario has~     changed profoundly. In many countries, there has been a significant increase in the~     prevalence, persistence and severity of AAs and a consequent increase in the socio-economic~     impact associated with these conditions. For these reasons, there is a strong need to develop~     effective strategies to prevent these conditions. To date, the AA etiopathogenesis is not yet~     fully defined. Genetic factors may predispose certain subjects to the development of AA, but~     these alone can not explain the change observed in the AA scenario over the last few years,~     renewing interest in environmental factors.~      Numerous scientific evidence demonstrate the role of eating habits in influencing human~     health. Many of the effects of the diet on human health are due to a modulation of intestinal~     microbiosis. The regulation of the immune system is one of the pathways through which dietary~     modifications from the earliest times of life can alter the susceptibility of the individual~     to the development of allergic manifestations. The diet during pregnancy and lactation~     represents the earliest possible influence on the development of the baby's immune system.~     Observational studies suggest the association between maternal diet during pregnancy and~     lactation and development of allergic pathologies in the unborn, but the data are still~     preliminary. Often, other important parameters such as the atopic status of the parents, the~     type of delivery, the number of brothers, exposure to common allergens, maternal infections~     or early life, smoking exposure were not taken into account of cigarettes. The Mediterranean~     diet (MD) is characterized by a high intake of fruit and vegetables, legumes and whole grains~     combined with a moderate consumption of red wine, and the use of olive oil as the main source~     of lipids. In some studies adherence to MD was inversely related to the incidence of asthma~     and allergic rhinitis, especially in children. High adherence to MD was associated with a~     positive change in intestinal microbiosis and the production of short chain fatty acids~     (SCFA), particularly butyrate, the main SCFA produced by intestinal fermentation of food~     fibers. SCFA regulates mucosal integrity and the immunological and non-immunological~     mechanisms involved in the development of oral tolerance.~      MD mechanisms during pregnancy in the prevention of childhood allergies are not yet fully~     known.~   "
17509|NCT03337789|"~     This study aims to investigate the efficacy and safety of Polygonatum sibiricum for sleep~     quality improvement.~   "
17510|NCT03337776|"~     It is estimated that there are about 1.4 million patients with colorectal cancer (CRC)~     worldwide, with a rising trend in CRC incidence in many Asian Pacific countries1. In Hong~     Kong, colorectal cancer ranks first in cancer incidence and second in cancer mortality based~     on data from 20142.~      Recent guidelines from USA, Europe and Asia Pacific region recommend CRC screening for~     average-risk asymptomatic individuals starting at age 503-5. Modalities such as guaiac-based~     fecal occult blood tests (gFOBT), fecal immunochemical tests (FIT), flexible sigmoidoscopy~     (FS), and colonoscopy are among the acceptable options for CRC screening3-5.~      Department of Health of Hong Kong launched a Colorectal Cancer Screening Pilot Program in~     late 2016. This is a subsidized program offering primary care consultation with FIT. For~     those subjects with FIT positive, colonoscopy specialist consultation and colonoscopy will be~     arranged.~      The local uptake rate of CRC screening was reported to be 24.5%8 , which is relatively low~     when compared to other developed county9.~      In recent years, social media (SM) has become an increasingly popular source of health~     information10. By providing an easily accessible and interactive channel of communication~     between reviewers and information providers, it has potential values for affecting public~     health. However, the effects of SM on uptake of CRC screening has not yet been studied.~      WhatsApp Messenger, is the most popular social media messaging app worldwide. This randomized~     controlled study will investigate the effect of WhatsApp vs telephone intervention on the~     uptake of CRC screening.~   "
17511|NCT03337763|"~     Enrolled patients implanted with Biotronik CRT-D and QP lead equipped with MultiPole pacing~     mode is grouped into which programmed into MultiPole pacing, or conventional bi-ventricular~     pacing mode. They are followed up by seven month post implantation, and predefined cardiac~     functional parameters are collected at each visit.~   "
17512|NCT03337750|"~     It is urgent to make evidence-based treatments (EBTs) for military personnel readily~     accessible in order to meet the growing demand for effective and efficient treatment for~     posttraumatic stress disorder (PTSD) in a timely manner. Effective EBTs for PTSD are~     available, but barriers to accessing care can deter military personnel from receiving~     treatment. Web-treatments represent an innovative way to overcome these barriers. The~     efficacy of previously developed web-treatments for PTSD appear promising, however, they are~     not based on treatment protocols with strong empirical support for their efficacy. No study~     to date has examined web-treatment of PTSD using a well-established treatment program.~      The purpose of this open trial is to examine the efficacy of 10 sessions of a web-version of~     Prolonged Exposure (PE), Web-PE, delivered over 8-weeks in 40 active-duty military~     personnel and veterans with PTSD who deployed post 9-11. Up to 60 individuals will be~     consented to obtain data from 40 for analysis. Participants will be assessed at pre-treatment~     and 1- and 3-months after treatment completion.~   "
17513|NCT03337737|"~     The study will be a double blind, placebo controlled cross over design with equal treatment~     and washout periods. Participants will sign an informed consent document prior to data~     collection and will provide descriptive information about their physical activity by filling~     out the Leisure and Physical Activity Survey. The participants will be 12 healthy, active~     college aged males. The participant will have height and weight determined via a triple beam~     balance with stadiometer, and their body fat% determine via a Bod Pod Gold Standard system.~      After wards the participants will supplement with either Placebo or Extreme Endurance (random~     assignment for order) for ten days. The first 4 days will the participants will ingest four~     tablets in the morning and evening (8 tablets total) followed by 6 days of three tablets in~     the morning and evening (6 tablets total). Following the supplementation period the~     participant will report to the human performance lab where they will be fitted with a mask to~     collect expired gases and will perform a 25 watt ramp protocol on an electronically braked~     cycle ergometer. During this test the participant will have a short warm up period, and then~     a computer will automatically adjust the workload on the bike such that a slope of 25~     watts/min is achieved. The test will conclude when the subject reaches volitional exhaustion.~     Expired gases will be assessed with a COSMED QUARK CPET system. Prior to, and every two~     minutes during the exercise lactate will be assessed via dermal puncture and a handheld~     monitor. Ten minutes after the cessation of exercise, a venipuncture will be performed in the~     antecubetal space and blood will be collected into a serum separator tube. This blood will be~     spun down in a clinical centrifuge and the serum drawn off and ammonia determined via~     enzymatic reaction. The remaining serum will be aliquoted and stored at -80 degrees Celsius~     for later analysis (muscle damage, oxidative stress, inflammation). Participants will then~     have a ten day rest period after which they will begin the 10 day supplementation period and~     exercise trial with the opposite supplement.~   "
17514|NCT03337724|"~     This study will evaluate the efficacy of ipatasertib + paclitaxel versus placebo + paclitaxel~     in participants with histologically confirmed, locally advanced or metastatic triple-negative~     breast cancer (TNBC) and in participants with locally advanced or metastatic hormone receptor~     positive (HR+)/ human epidermal growth factor receptor 2 negative (HER2−) breast~     adenocarcinoma who are not suitable for endocrine therapy.~   "
17537|NCT03337412|"~     An uncontrolled, non-randomized, open-plan, multi-centre study of treatment and therapeutic~     education in endocrinology-diabetes-Nutrition that seeks to assess the interest of an adapted~     physical activity educator for the implementation In place of physical activities in the~     management and prevention of overweight and obesity. The proposed study seeks to promote the~     physical activity (PA) to patients and employees, including the encouragement of physical~     activity in a guided and personalized way, through workshops on working time, and follow-up~     of the evolution of the PA through a Adapted questionnaire.~   "
17515|NCT03337711|"~     The study will collect 100 ⅡA - ⅢA stage non-squamous NSCLC tumor tissue and blood specimens~     (Include: (1) tissue by operation: 3 specimens from different regions of each patient; (2)~     Blood: preoperative blood (within one week), postoperative blood (3-4 weeks after operation~     (before adjuvant chemotherapy), 20 weeks after operation (1 month after adjuvant~     chemotherapy), 1 year after operation). Capture-based sequencing(168 genes panel +UMI) will~     performed. All patients are recommended for pemetrexed combined platinum adjuvant~     chemotherapy for 4 cycles(Moderate-dose Chemotherapy) 3-4 weeks after operation. The clinical~     data should be collected until disease progression. The relationship of postoperative ctDNA~     and recurrence defined by clinical imaging will be analyzed, as well as the correlation of~     tissue and postoperative blood NGS results.~   "
17516|NCT03337698|"~     This study will evaluate the efficacy, safety, and pharmacokinetics of immunotherapy-based~     treatment combinations in patients with metastatic non-small cell lung cancer (NSCLC).~      Two cohorts will be enrolled in parallel in this study: the first-line cohort will consist of~     patients who have not received any systemic therapy for their disease and the second-line~     cohort will consist of patients who progressed after receiving a platinum-containing~     chemotherapy regimen and a checkpoint-inhibitor treatment. In each cohort, eligible patients~     will be assigned to one of several treatment arms.~   "
17517|NCT03337672|"~     Emergence delirium is a common complication in children after anesthesia. The incidence of~     emergence delirium is reported upto 50%. Prevention of emergence delirium in children is~     important not only for the patient safety but also for the satisfaction of the parents.~     Midazolam is the most commonly used medications for prevention of emergence delirium.~     However, it might lead to delayed awakening from anesthesia and respiratory depression. In~     this study, the investigators will evaluate whether dexmedetomidine can be effectively and~     safely administered for prevention of emergence delirium in children compared to midazolam.~   "
17518|NCT03337659|"~     In Alberta, one in every twelve babies is born preterm. Compared with their full term~     counterparts, preterm infants who survive are at higher risk for respiratory problems,~     jaundice, infections, feeding problems, behavioural problems, and neuro-developmental~     disabilities, including cognitive delays, and visual and hearing impairments. As a result,~     parents must leave their preterm babies in the hospital to fully develop enough to care for~     them at home. When it is time for discharge, parents are often unprepared to look after their~     baby because they may have limited involvement in the care of their baby in hospital. In~     addition to the distress and costs to parents of having a baby in hospital, health system~     costs are also increased the longer a baby is in hospital. The aim of this novel health~     services study is to assess the longer-term outcomes and costs, to 18 months corrected age,~     of Family Integrated Care (FICare) for moderate and late preterm infants admitted to a Level~     II neonatal intensive care unit (NICU). A cluster randomized controlled trial (cRCT) of~     FICare is currently in progress. FICare is a psycho-educational intervention that empowers~     parents (mothers and fathers) to sequentially build their knowledge, skill, and confidence so~     the family is well-prepared to care for their preterm infant before discharge. The FICare~     cRCT evaluates outcomes related to infant global development and maternal psychosocial~     distress at 2 months. At 2 months, it is difficult to predict longer term outcomes for~     moderate and late preterm infants. A follow-up study at 18 months will provide evidence of~     the sustainability of any effects, and longer-term cost savings upon which to inform policy~     decisions about full-scale implementation of FICare in Level II NICUs.~   "
17519|NCT03337646|"~     The purpose of this study is to evaluate the effect and safety of Lisdexamfetamine dimesylate~     (Vyvanse®) in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children~     and adolescents with ADHD and comorbid Autism Spectrum Disorder (ASD). This would be a novel~     study as there is no known safety or efficacy data for amphetamine based medications in this~     population. In addition, although health related quality of life and executive function are~     known to improve with the treatment of lisdexamfetamine dimesylate in the ADHD population~     (Banaschewski 2013; Findling 2009; Turgay 2010), it has not been shown in the co‐morbid ADHD~     and ASD population. ADHD is the most common pediatric neurobiological condition affecting~     approximately five percent of the pediatric population (Feldman 2009). ASD is being~     increasingly recognized as affecting a substantial amount of the pediatric population, with~     recent prevalence data showing 1 in 68 affected (Baio, 2014). Prior to the introduction of~     DSM‐5 (APA, 2013), exclusion criteria precluded the diagnosis of ADHD when ASD was present.~     Studies have shown that 41%‐71% of children with ASD also meet criteria for ADHD (Goldstein~     2004, Sturm 2004,Yoshida 2004, Gadow 2006). This means that up to 1% of the population may~     have co‐morbid ADHD and ASD. With the official recognition of this comorbidity, treatment of~     comorbid ADHD when ASD is also present has been increasingly recognized as an important~     strategy in improving executive functioning and quality of life in those affected. Studies~     have indicated that some of the medications commonly used to treat ADHD, are effective and~     safe when used in comorbid ADHD and ASD. At this time, there have been well designed studies~     demonstrating safety and efficacy for methylphenidate (Ghuman et al. 2009; Handen et al.~     2000; Quintana et al. 1995; RUPP 2005), guanfacine XR (Posey 2004; Scahill 2015), and~     atomoxetine (Arnold 2006; Harfterkamp 2012).~   "
17520|NCT03337633|"~     High cognitive load activities can influence energy intake from food. It is unknown how~     restaurant menu designs may affect patrons in terms of cognitive demand and subsequent~     ordering of food.Objective: Our objective was to develop and experimentally test menu designs~     that differ in cognitive load to test the subjective and objective stress measures on food~     ordering.~   "
17521|NCT03337620|"~     This is a double blind placebo-controlled study which will evaluate the efficacy of~     bupivacaine compared to saline, delivered by the Tx360® device to the sphenopalatine ganglion~     (SPG), to treat chronic migraine headache. The Tx360® is a nasal applicator which is cleared~     through the FDA for transnasal medication delivery, including delivery to the SPG. The SPG~     has been implicated in a variety of cephalalgias. It is critical to the success of this~     intervention that the blocking agent be accurately delivered to this area as it is the only~     non-bony access to the pterygopalatine fossa (PPF). Subjects meeting inclusion/exclusion~     criteria will receive 12 intranasal treatments to the SPG over a period of 4 weeks with~     follow-up monthly for an additional 3 months post-treatment.~   "
17522|NCT03337607|"~     This study tests the hypothesis that radial extracorporeal shock wave therapy (rESWT) in~     combination with the non-steroidal anti-inflammatory drug Celecoxib and the antispasmodic~     drug Eperisone (hereafter, C-E drug therapy) is statistically significantly more effective~     than either rESWT or C-E drug therapy alone in the treatment of chronic non-specific low back~     pain.~   "
17523|NCT03337594|"~     The purpose of this study is to compare contrast agents, Dotarem or MultiHance. The study~     will test to see how much of these two contrast agents are deposited in the bones or tissues~     of pediatric patients. The patients receiving contrast will then be compared against~     pediatric patients who have not received any contrast prior to cardiac surgeries.~   "
17525|NCT03337568|"~     The purpose of this study is to evaluate the effect of various clinical variables including~     HLA-disparity and NK cell-related variables, upon outcomes of allogeneic hematopoietic cell~     transplantation (HCT) using uniform conditioning regimen including busulfan, fludarabine, and~     antithymocyte globulin (ATG) in patients with acute myeloid leukemia (AML) in the first~     complete remission (CR). The donors for allogeneic HCT include HLA-matched siblings, matched~     unrelated donors, and haploidentical family donors.~      Therefore, the endpoints of the study are engraftment, secondary graft failure, acute and~     chronic graft-versus-host disease (GVHD), immune recovery, infections, leukemia recurrence,~     non-relapse mortality, and relapse-free (RFS) and overall survival (OS) of patients.~   "
17526|NCT03337555|"~     A comparison of intubation time, difficulty of intubation in nasotracheal intubation using~     McGrath MAC®, Pentax-AWS® and Macintosh direct laryngoscopes~   "
17527|NCT03337542|"~     This study is enrolling participants by invitation only. This is an open-label, safety~     extension study for subjects who participated in the ARC007 study.~   "
17528|NCT03337529|"~     Restless legs syndrome (RLS) is defined as the spontaneous movement of the limbs (mainly~     legs) associated with unpleasant - painful sensation which is relieved by moving the affected~     limb. It is a common disorder in hemodialysis patients that leads to insomnia, impaired~     daytime functioning and quality of life. Symptoms of RLS are estimated to affect up to 25% of~     patients on dialysis when the international RLS diagnostic criteria are applied. Various~     pharmacological and non-pharmacological interventions have been used to treat primary RLS.~     However, the evidence for use of these interventions in people with End stage renal disease~     is not well established; and some have serious side effects. Because high oxidative stress~     has been implicated in the pathogenesis of RLS, investigators thought of evaluating the~     efficacy of vitamin C in reducing the severity of RLS symptoms in hemodialysis patients in~     this randomized, double-blind, placebo-controlled, two arm parallel trial. To note that only~     two studies were done worldwide that proved the efficacy of vitamin C in those patients.~   "
17529|NCT03337516|"~     In this open-label, single-center, non-randomized patients with AML (Acute Myeloid Leukemia)~     and receiving all induction chemotherapy and consolidation consisting of cytarabine under the~     care usual for this pathology, will be included. Each patient will be followed and for the~     development of toxicities, treatment response and progression-free survival. In addition to~     the usual care set out above, each patient will undergo a series of constitutional genetic~     investigations conducted by NGS on markers related to pharmacokinetics cytarabine. Another~     set of blood samples will also calculate, according to a Bayesian approach, individual~     pharmacokinetics of cytarabine and its metabolite, arabinosine-uracil.~      This study should allow the correlation between pharmacogenetics and patient plasma exposure,~     that would eventually balance improved efficacy / toxicity of this molecule through a~     customization regimens, achieved so far on a empirical basis. If validation of our data, a~     dosage of therapeutic pre CDA could help in predicting pharmacodynamics of cytarabine~     individual dose adjustment, as is done for the 5-FU and DPD.~   "
17530|NCT03337503|"~     Seeking for effective therapeutic strategies, the investigators are proposing to test the~     effectiveness of different formulations of medical cannabis oil to alleviate chronic pain,~     which was partially relieved with conventional prescriptions. Furthermore, the investigators~     would like to assess the effect of different formulations of medical cannabis oil on other~     symptoms associated to chronic pain like anxiety and depression, as well as insomnia and~     appetite. Finally, as recently recommended for clinical studies on medical cannabis, the~     investigators will examine the safety profile of different cannabis formulations focusing on~     the following elements: a real chronic administration with more than two weeks of treatment,~     a larger number of patients, and the clinical relevance of medical cannabis oil to change the~     amount and type of concomitant medications used to control chronic non-cancer and cancer~     pain.~   "
17531|NCT03337490|"~     This is a phase 3 randomized, multi-center, double-blind, placebo controlled, parallel group~     design study.~   "
17532|NCT03337477|"~     The study is designed to determine if ZS 10g administered up to three times over 10h added to~     insulin and glucose in patients presenting with hyperkalemia will prove tolerable and~     efficacious. Patients will receive ZS or Placebo on top of standard of care treatment with~     insulin and glucose.~   "
17533|NCT03337464|"~     To assess 30 active people (15 with PD, 15 without) before and after 30 minutes of pedaling~     exercise using EEG-EMG, cognitive, mood and motor assessments.~   "
17534|NCT03337451|"~     This protocol is a follow-up for patients receiving continuation of OPN-305 monotherapy~     treatment or combination treatment with azacitidine after completion of the dose confirming,~     dose expansion and HMA naïve parts of the main study OPN-305-106.~   "
17535|NCT03337438|"~     Heavy episodic drinking (HED) among college students remains a concern within the U.S., as~     rates of HED are still high in this population. Though a variety of brief motivational~     interventions for alcohol use in college students have demonstrated significant effects,~     these effects are often small and not consistently maintained over time. Personalized~     feedback interventions (PFIs) are a particularly promising approach, as these are often~     acceptable to college students, as well as low-cost, and easy to disseminate. Though~     presentation of interperson discrepancy via descriptive and injunctive norms has shown~     consistent effects within PFIs and received much attention in the literature, intraperson, or~     ideal-actual self discrepancies, has largely been ignored. Drawing from cognitive dissonance~     theory, self-regulation theory, and motivational interviewing, the current study aims to~     evaluate the efficacy of an alcohol PFI with a values component to incorporate ideal-self~     discrepancy into a typical intervention.~   "
17536|NCT03337425|"~     This pilot study aims to assess patient satisfaction and preliminary efficacy of a~     psychoeducational group treatment, using a randomized waitlist-controlled trial, at two~     different outpatient clinics in mid-Norway. All participants will receive standard treatment~     during the intervention period. Assessment of client satisfaction (CSQ 8), general~     self-efficacy (GSE-6), ADHD-related quality of life (AAQoL) symptoms of ADHD (SCL-9; ASRS),~     and work participation will be conducted at time of recruitment prior to randomization (T0),~     pre- (T1), post-treatment (T2), with a 10 week follow-up.~   "
17538|NCT03337399|"~     This research study is evaluating ways to provide palliative care to patients who have~     recently been diagnosed with lung cancer~   "
17539|NCT03337386|"~     Traditional methods for intravascular volume status assessment include physical examination,~     raised leg test, central venous pressure (CVP) and pulmonary artery catheters occlusion~     pressure (PAWP). Central venous pressure and pulmonary artery occlusion pressure are invasive~     and associated with significant complications. More recently, a number of less invasive~     techniques have been introduced, but they lack standardization and reliability.~     Ultrasonically, inferior vena cava collapsibility can detect hypovolemia non-invasively.~   "
17540|NCT03337373|"~     Pathophysiological changes influenced by multiple factors in critically ill patients, has a~     significant impact on pharmacokinetics (PK) and pharmacodynamics (PD) of cisatracurium. In~     order to understand better and find an appropriate dosing regimen, the purpose of this study~     is to investigate the PK and PD of a loading dose cisatracurium in critically ill patients.~      Cisatracurium, nondepolarizing neuromuscular blocking agents (NMBAs), are commonly used in~     intensive care units because of a lesser effect on hemodynamic parameters and a reduction in~     mortality rate in ARDS patients. Loading dose recommended in clinical practice guidelines for~     sustained neuromuscular blockade in the adult critically ill patient is 0.1-0.2 mg/kg. Then,~     maintenance dose of 1-3 mcg/kg/min is followed regarding indications, such as ARDS. However,~     this recommended loading dose might not be adequate in critically ill patients, the study in~     this specific population might be needed.~   "
17541|NCT03337360|"~     Infertility is a worldwide problem and about 10%-15% of all couples will be affected by the~     inability to have children. In approximately 50% of infertile couples a male factor is~     involved. Male infertility is of multifactorial origin. In the past decade, the role of~     oxidative stress on sperm has been researched thoroughly and found to be the problem in 30%~     to 80% of male infertility cases.~      Impryl® is a nutritional supplement mainly consisting of vitamin B, which works on the~     metabolic system by activating the one carbon cycle and recycling of homocysteine without the~     use of any direct strong antioxidants.~      In this study the investigators want to determine the effectiveness of nutritional supplement~     Impryl® in men of infertile couples on ongoing pregnancy rate, with or without assisted~     reproduction technology (ART).~   "
17542|NCT03337347|"~     To determine whether the presence of circulating/disseminated tumor cells (CTCs/DTCs) in the~     blood and bone marrow of colorectal cancer (CRC) patients with localized disease is a~     negative prognostic factor, and to find correlations with other clinical/pathological disease~     characteristics.~   "
17543|NCT03337334|"~     Transcranial alternating current stimulation (tACS) is a noninvasive neuromodulation method~     that works by passing alternating electric current between electrodes where at least one of~     them is attached to the head. While tACS applied over the motor cortex at the general applied~     amplitude (1 mA) and using patch electrodes has been shown to entrain physiological tremor in~     healthy volunteers, the aim of this study is to test the feasibility of using high-amplitude~     tACS and to assess the effect of different electrode montages and stimulation sites in~     entraining physiological tremor. First, 10 subjects (arm 1) will be stimulated with 2 mA~     current amplitude applied between saline soaked patch square electrodes and comparison will~     be done between motor cortex stimulation and peripheral cortex stimulation. Then, 10 subjects~     (arm 2) will be stimulated using focused 4x1 montage with gel-filled cup-electrodes and 5 mA~     amplitude and comparison will be made between motor cortex and occipital cortex stimulation.~     Three outcome measurements will be measured during the experiments which are: tremor~     entrainment, phosphene intensity and phosphene threshold.~   "
17544|NCT03337321|"~     The aim of the research project is to develop and validate a new digital measure of affective~     patient experience in maternal care. In this validating study extensive collection of~     affective ratings of 195 emotion words is collected. Pregnant women at different gestational~     stages are asked to provide affective ratings of 195 emotion words in relation to the~     dimensions: pleasure, arousal, dominance. Based on these ratings population averages and~     properties of emotion words will be calculated. The measure will be developed in respect to~     the analysis of affective rating and supplementing data.~   "
17545|NCT03337308|"~     The purpose of this study is to determine if Bempedoic Acid (BA) + Ezetimibe (EZE) in a~     fixed-dose combination (FDC) is effective and safe versus its individual components and~     placebo in patients with elevated LDL cholesterol treated with maximally tolerated statin~     therapy.~   "
17546|NCT03337295|"~     The purpose of this study is to assess the correlation between the thickness of lipid layer~     and the meibomian gland dysfunction.~   "
17547|NCT03337282|"~     The purpose of this study is to determine what percentage of patients have cognitive problems~     (for example, memory or concentration difficulties) after surgery and anesthesia, what the~     characteristics of these problems are, and whether they persist over time. In particular, the~     investigators want to study this in the French-speaking Quebec population with cognitive~     evaluation tools adapted for this population.~   "
17548|NCT03337269|"~     This study aims to assess the effectiveness of targeted educational interventions in~     increasing the acceptability and knowledge of the HPV vaccine among females ages 12 through~     26. Subjects will be randomized to one of three study arms (no intervention, viewing an~     educational video or reading an educational handout) and then a questionnaire will be~     administered to assess knowledge and acceptability of the HPV vaccine. Subject charts will be~     reviewed to assess for initiation of the HPV vaccine.~   "
17549|NCT03337256|"~     Acute upper gastrointestinal bleeding (UGIB) is a common cause for attendance to the~     Emergency Department with a wide range of clinical severity, ranging from insignificant to~     life-threatening. While there is robust data to support the benefit of upper endoscopy within~     24 hours of admission, the implementation of early upper endoscopy while patients are still~     in the emergency room has not been widely accepted due to lack of added benefit in terms of~     patient outcome such as mortality and re-bleeding rate. However, the use of upper endoscopy~     in the emergency room with the purpose of facilitating early discharge of low risk patients~     with upper gastrointestinal bleeding has not been studied.~   "
17550|NCT03337243|"~     The purpose of this study is to compare the pain, functioning and pain medication consumption~     of knee osteoarthritis (OA) patients who have allogenic cytokines derived from human amniotic~     membranes (HAM) and allogenic mesenchymal stem cells derived from human umbilical cord~     Wharton's Jelly (HUMCWJ) implanted into the affected knee with knee OA patients who~     self-select to be in a non-intervention control group.~   "
17552|NCT03337217|"~     In the United States, colonoscopy has become the most commonly used screening test for~     colorectal cancer. Colonoscopy is typically performed with the patient starting in the left~     lateral decubitus position, however there is little data to support this practice and~     starting position is variable amongst individual gastroenterology physicians.~      The investigators plan to randomize patients with Body Mass Index >30 that are presenting to~     the University of Virginia for colonoscopy to either the prone or left lateral decubitus~     position. The investigators will then record and compare cecal intubation times as well as~     amount of sedation used and complications to help determine which position is superior for~     this patient population.~   "
17553|NCT03337204|"~     This study designs and tests a multi-component intervention- Engaged4Life- designed to~     enhance physical activity (PA), cognitive activity (CA), social interaction (SI) and personal~     meaning (PM) in low-engaged community-dwelling older adults' everyday life activities~     through: 1) technology-assisted self-monitoring of PA, CA, SI, and PM activity engagement, 2)~     psycho-education + goal setting (via a 3-hour workshop), and 3) one-on-one peer mentoring~     (via phone 2X/week for 3 weeks) to support goal implementation. 15 adults age 65 or older~     will be randomized to receive all 3 intervention components and 15 to receive only the~     technology-assisted self-monitoring component.~   "
17554|NCT03337191|"~     Caudal epidural block has been widely used, especially in pediatric surgery, to provide~     intraoperative and postoperative analgesia by affecting the region between T10 and S5~     dermatomes in surgeries below the umbilical level.~      In conventional single-shot caudal block, the needle is inserted through the skin with a~     60-80 degrees angle, until the sacrococcygeal ligament is passed through. Then the angle of~     the needle is decreased to 20-30 degrees and inserted further for an additional 2-3 mm,~     entering into the sacral canal.There is a risk of dural or vascular puncture when the needle~     is passing through sacral canal. Other complications are the soft tissue bulging,~     intraosseous injections and systemic toxicity.~      Many anatomical variations have been reported for sacral hiatus and sacral cornua. Therefore,~     the success rate of the classic caudal epidural anesthesia method in pediatric patients has~     been reported to be about 75%.~      With the usage of ultrasonography in regional anesthesia, many advantages have been reported.~     Ultrasonography is helpful for visualization of the sacral hiatus, sacrococcygeal ligament,~     duramater, epidural space and the distribution of the local anesthetic agent within the~     epidural space. Therefore, this significantly increases the block success.~      The primary aim of this study was compare the success rate of ultrasound guided sacral hiatus~     injection and conventional sacral canal injection. Secondary objectives are; block performing~     time, number of needle puncture, success at first puncture and complication rate.~   "
17555|NCT03337178|"~     Spinal stenosis is a common orthopedic spine condition that limits individuals ability to~     walk and stand because of nerve compression. Surgical treatment can alleviate leg pain and~     improve function such as increasing physical activity. This study will use Fitbit technology~     to monitor patient's post-operative physical activity. It will evaluate the efficacy of a~     Fitbit incentive based walking program on improving post-operative physical activity and~     rehabilitation.~   "
17556|NCT03337165|"~     Tolerogenic dendritic cell (tDC)-based clinical trials for the treatment of autoimmune~     diseases are now a reality. Clinical trials are currently exploring the effectiveness of tDC~     to treat of type 1 diabetes mellitus, rheumatoid arthritis, multiple sclerosis and Crohn's~     disease. The general objective of this study is to evaluate the safety and tolerability of a~     single intra-articular injection (into the knee joint) of autologous monocyte-derived~     dendritic cells generated in the presence of interferon-alpha (IFN-α)/granulocyte-macrophage~     colony-stimulating factor (GM-CSF) and tolerized with Dexamethasone in rheumatoid arthritis~     (RA) patients.~   "
17557|NCT03337152|"~     A clinical study designed to develop and inform an individual risk of hemolysis model based~     on individual red blood cell G6PD levels. Volunteers who are eligible to treatment with~     primaquine as per national guidelines and with confirmed normal G6PD levels as per the~     fluorescent spot test will be exposed to treatment regimens of either primaquine alone for 14~     days or 3 day chloroquine with concomitant primaquine for 14 days. The volunteers will be~     followed intensively during treatment and for 14 days after treatment for haematologic~     measures, G6PD quantification, and drug level assays.~   "
17558|NCT03337139|"~     Most adults in the U.S. are overweight or obese and find maintenance of weight loss~     difficult. This study is designed to aid in the development of a lifestyle modification~     program that can facilitate weight loss maintenance, without requiring long-term visits to a~     clinic for maintenance treatment.~   "
17559|NCT03337126|"~     Appili Therapeutics Inc. is developing an oral suspension formulation of metronidazole~     (ATI-1501), a taste-masked reformulation of metronidazole. The purpose of this study is to~     compare the relative bioavailability of ATI-1501 with the Reference Listed Drug (RLD) in~     healthy, adult volunteers to determine that it is Bioequivalent.~   "
17560|NCT03337113|"~     Smoking remains the leading cause of preventable death in the United States, and current~     first-line treatments leave the majority of tobacco dependent individuals unable to quit. The~     inability to quit despite motivation to do so, is thought to result in part, from~     self-control failure. Working memory (WM) deficits contribute to imbalanced self-control and~     allow automatic impulses to drive behavior. Thus, WM plays a critical role in addictive~     behavior, and is particularly relevant to smoking. Indeed, a strong link between WM and~     smoking has been established in the literature; most notably, degree of WM impairment and~     deficits in activation in associated brain regions predict time to relapse, and WM moderates~     the relationship between craving and relapse. Given these insights, researchers have been~     examining interventions that may target WM including WM training (WMT) and repetitive~     Transcranial Magnetic Stimulation (rTMS). WMT involves taxing this executive function~     repeatedly over time and has shown positive preliminary results in improving measures of~     self-control and reducing consumption of addictive substances. Similarly, rTMS, a~     non-invasive brain stimulation procedure that stimulates neuronal tissues and increases~     cortical excitability, has been shown to increase WM capacity and reduce craving and~     consumption of several addictive substances including nicotine. While these interventions~     have demonstrated initial promise in affecting addictive behaviors, the magnitude and~     durability of their effects may be limited. Recently, researchers have posited — but not yet~     empirically tested — that WMT administered in combination with rTMS may result in an additive~     or supra-additive effect in treating addictive processes. This is highly significant; the~     clinical utility of rTMS over current first line treatments may be limited if factors with~     potential to enhance its effectiveness are not examined. Given these recent advances in the~     literature, the primary objective of the proposed study is to evaluate the individual and~     combined effects of Working Memory (WM) training and repetitive Transcranial Magnetic~     Stimulation (rTMS) on WM performance and smoking behaviors as well as critical mediators of~     these effects. These aims will be examined in a sample of tobacco dependent adults (N=130)~     utilizing a 2x2 factorial experimental design including four groups (WMT+rTMS, sham WMT+rTMS,~     WMT+sham TMS, and sham WMT+sham rTMS) capable of isolating independent and combined effects~     of WMT and rTMS.~   "
17562|NCT03337087|"~     This phase I/II trial studies the side effects and best dose of liposomal irinotecan and~     rucaparib and when given together with fluorouracil and leucovorin calcium and to see how~     well they work in treating patients with pancreatic, colorectal, gastroesophageal, or biliary~     cancer that has spread to other places in the body. Drugs used in chemotherapy, such as~     liposomal irinotecan, fluorouracil, leucovorin calcium, and rucaparib, work in different ways~     to stop the growth of tumor cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading.~   "
17563|NCT03337074|"~     For some years investigators have known that the health of fathers at the time their baby is~     conceived has an influence on the health of their child in the future. Many studies looking~     at this effect have investigated fathers with obesity and other metabolic disorders. These~     disorders can alter the risk of obesity and diabetes in the children of these men. More~     recently, studies have been undertaken to establish the mechanism by which this risk is~     inherited by the children. Studies of sperm have identified that changes in the structure and~     function of the sperm play a role.~      Primary Sclerosing Cholangitis (PSC) and Primary Biliary Cholangitis (PBC) are included in a~     group of cholestatic liver disorders that are associated with elevated levels of bile acids~     in the blood (cholestasis). A previous study has established that children born to women who~     have cholestasis during pregnancy are at an increased risk of obesity later in life. Our~     study will investigate whether there is a similar effect on the health of children if their~     father has cholestasis.~      The study has 2 arms, the Sperm Epigenome arm and the Outcomes arm.~      In the Sperm Epigenome arm of the study, the structure and function of sperm from men with~     PSC, PBC and other cholestatic liver disorders will be investigated and compared to the~     structure and function of sperm from healthy men.~      In the Outcomes arm of the study, basic health parameters of fathers who had PSC, PBC or~     another cholestatic liver disease either before or after their child was conceived will be~     studied. Basic health parameters will also be studied in their child when the child is~     between 16 and 25 years of age.~   "
17564|NCT03337061|"~     To evaluate the efficacy of mediation therapies on measures of sleep and arousal for people~     with chronic insomnia and with this the viability of smartphone delivered meditation based~     approaches at a population level.~   "
17565|NCT03337048|"~     The objective of the study is to explore and understand how urodynamic parameters are~     affected when emptying the bladder with an intermittent catheter.~   "
17566|NCT03337035|"~     Because oral probiotics reported to potentially induce endogenous Oxytocin, and Oxytocin has~     been reported to improve social behaviors, the investigators will conduct a pilot trial to~     compare the effects of probiotics and Oxytocin on social behavioral changes in ASD children.~     Additionally, the investigators will check oxytocin levels, and perform brain fMRI in some~     subjects, in order to determine which treatment is more efficient, sustainable, and~     practical, and whether both treatments in combination are better than either treatment alone.~     If the trial is conclusive, the investigators will conduct a trial in large scale to~     understand more the mechanism of ASD behaviors and corresponding effective interventions.~   "
17567|NCT03337022|"~     This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the~     safety, tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and immunogenicity of~     CC-90006 following administration of multiple subcutaneous doses in subjects with mild to~     moderate plaque-type psoriasis.~   "
17568|NCT03337009|"~     In the setting of naloxone standing orders, this study will assess the impact of a targeted,~     web-based overdose prevention and naloxone intervention for patients prescribed chronic~     opioid therapy. Outcomes are changes in opioid risk behaviors, naloxone uptake, and knowledge~     about overdose and naloxone.~   "
17569|NCT03336996|"~     Nowadays, the stem cell therapy is a promising method in treatment of the traumatic nerve~     fiber injuries. And the clinical use of umbilical cord mesenchymal stem cells has been~     approved by FDA. However, the results are inconsistent from both human study and animal~     research, it often difficult to visualize the reconstruction of the motor circuits. A~     separate application of DTI could not precisely reveal white matter integrity. Combining~     blood oxygen level-dependent(BOLD)-functional magnetic resonance imaging(fMRI) with diffusion~     tensor-based tractography (DTT), to detect neural activities in the brain involved in the~     motor function restore and then using the two seeds method to reconstruct the nerve fibers~     between these connecting regions. The main aim of this study: i. To characterize and evaluate~     functional and anatomical changes of nerve fiber injuries after umbilical cord mesenchymal~     stem cells transplantation with BOLD drived-diffusion tensor imaging(DTI). ii. To determine~     the therapeutic efficiency of umbilical cord mesenchymal stem cells and also the utility of~     the integration of BOLD-fMRI and DTI. iii. To correlate the imaging results with the~     electrophysiology outcomes.~   "
17570|NCT03336983|"~     This study was undertaken to evaluate bone response in metastatic prostate cancer patients~     treated with Enzalutamide with or without Zoledronic Acid in combination with luteinizing~     hormone-releasing hormone (LHRH) analogue with the use of Whole Boby (WB) DW-MRI.~   "
17571|NCT03336970|"~     Ninety asymptomatic maxillary anterior teeth with periapical lesions were treated in single~     versus multiple visit root canal treatment. Half of the teeth were randomly assigned to the~     single-visit (SV) group and received an additional final rinse with 2% CHX before obturation.~     The other teeth were treated in multiple visits (MV) with calcium hydroxide dressing. All~     patients were recalled and investigated clinically and radiographically for 24 months.~   "
17572|NCT03336957|"~     Background: The purpose of the present study is to research whether stress scale scores alter~     with relationship to gingival inflammation and examine the impact of non-surgical periodontal~     therapy during pregnancy on the levels of cytokines in gingival crevicular fluid (GCF) and on~     salivary stress-related hormones.~      Methods: 30 non-pregnant (control group) and 30 pregnant women (test group) who fulfilled the~     study inclusion criteria were chosen. The participants with moderate/severe gingivitis were~     included. Clinical data and samples of GCF and salivary were collected at baseline and after~     periodontal therapy. The levels of cytokines interleukin-1 beta (IL-1β) and IL-10, and~     concentration of salivary chromogranin A (Cg A) hormone were analyzed by enzyme-linked~     immunosorbent assay kits.~   "
17573|NCT03336931|"~     This is a multicentre prospective study of the feasibility and clinical value of a diagnostic~     service for identifying therapeutic targets and recommending personalised treatment for~     children and adolescents with high-risk cancer.~   "
17575|NCT03336905|"~     About 700 new cases of cancer are recorded each year among TYAC aged 15 to 25 years old in~     Rhône-Alpes region (France); more than 200 are treated and supported within the TYAC~     Department of the Institute of Hematology and Oncology Pediatrics (Centre Léon Bérard-Civil~     Hospice of Lyon). These patients survive from their disease in 80% of cases; they have six~     times more likely to develop a risk of second primary cancer (SCP) than their peers. This~     risk of SCP is multifactorial and varies depending on the type of first cancer, treatment~     received and the prevalence of risk factors (smoking, overweight, sedentary lifestyle,~     environmental exposures...). This project aims to implement a clinical program based on~     adapted physical activity (APA) and cancer prevention recommendations for TYAC during the~     active treatment period (4-6 months). The methodology used series of assessments of APA~     sessions and information meetings dedicated to cancer prevention and SCP risk~     recommendations. It mobilizes regularly the health care team of TYAC Department, TYAC~     associations, sports structures and associations involved in cancer prevention at the~     regional level. Assessment of TYAC satisfaction regarding the project, benefits in terms of~     exercise practice, and knowledge improvement on cancer prevention recommendations, are~     assessed throughout the program.~   "
17576|NCT03336892|"~     This study seeks to quantify the impact of recommended mental health care coordination~     practices on patient experiences of care, (i.e. satisfaction, stigma, quality of mental~     health care), evaluate the efficiency and effectiveness of the intervention (i.e. care~     coordination, timing, unmet needs), and assess mental health outcomes (i.e. symptoms and~     functioning, involvement with law enforcement/juvenile justice system; rates of substance use~     /abuse, service utilization) in a population of 16-22 year-old youth receiving primary care~     in a D.C. urban academic adolescent medicine practice, using standardized outcome measures.~   "
17577|NCT03336879|"~     Background: An imbalance between prefrontal cortex (PFC) and the mesolimbic reward system has~     been suggested to contribute to GD. GD patients showed increased functional connectivity~     between regions of the PFC and mesolimbic reward system, as well as reduced connectivity in~     the area of the PFC. The altered interaction between prefrontal structures and the mesolimbic~     reward system in GD shares similarity with functional organization reported in Substances Use~     Disorders (SUDs), suggesting a more general pathophysiology for addictive disorders~      Objectives: To test if rTMS can reduce craving and playing in Gambling Disorder, and also~     affect several mood, behavioral and cognitive alterations associated with prolonged Gambling~     Disorder.~      Eligibility: Healthy, right-handed adults ages 18-65 who do have Gambling Disorder.~      Design: This is a non-randomized, open label study. The study includes three phases: 1) a~     rTMS continued treatment phase; 2) a rTMS follow-up; and 3) a no rTMS follow-up.~      Prior to participating, participants will be screened with:~        -  Questionnaires~        -  Cognitive tests~        -  Medical history~        -  Physical exam~      After being enrolled, baseline behavioral and imaging data will be collected. In particular,~     participants will undergo:~        -  Questionnaires~        -  Cognitive tests~      During the continued rTMS phase, participants with Gambling Disorder will receive real rTMS.~     Repetitive TMS will be delivered during 10 outpatient treatment days, over 2 weeks (5~     days/week). Following this phase, subjects will have 12 follow-up visits (once/weekly),~     during which they will receive rTMS, and behavioral assessments will be performed. At the end~     of the rTMS follow up period, participants will further receive 3 follow up visits (once a~     month), during which rTMS will not be performed, but behavioral data will be collected.~      Treatment includes:~        -  rTMS: A coil is placed on the head. Brief electrical current passes through the coil. At~          each visit, participants will receive two rTMS sessions, with a 1hr interval between~          sessions. At the beginning of each rTMS session, they view gambling-related images for~          few minutes.~        -  Repeat of screening tests and questionnaires~   "
17578|NCT03336866|"~     This study evaluates the ability of IXT-m200 to change methamphetamine concentrations in~     blood and alter the way methamphetamine feels. Participants will receive either placebo, a~     low or high dose of IXT-m200, in addition to methamphetamine challenge doses.~   "
17579|NCT03336853|"~     The persistence of blood may significantly affect final sealing with the persistence of~     microleakage (Zmener et al. 2008, Roggendorf et al. 2007).~      In cases of copious bleeding from root canals, calcium hydroxide, anesthetic solution with~     1:50,000 epinephrine or ferric sulfate placed on a sterile paper cone, are recognized as~     effective hemostatic agents (Magnusson 1971, Kouri et al. 1969, Dannenberg 1974).~      The purpose of this study was to test the reduction of root canal bleeding in terms of~     significant percentage change for millimeters of blood in the canal at 2 different time~     points (baseline and after treatment with HybenX )~   "
17580|NCT03336840|"~     The purpose of this clinical trial is to evaluate the safety and effectiveness on the~     clinical and biological parameters of reproductive-aged PCOS women after a 12-week metformin~     and/or probiotics administration.~   "
17581|NCT03336827|"~     The end of treatment marks the beginning of a challenging period for breast cancer patients.~     While this period often provokes a sense of relief, it can also be a source of apprehension~     and vulnerability regarding the future. Patients may be brought to feel contradictory~     thoughts and emotions impacting their quality of life such as anxiety linked to uncertainty~     and fear of cancer recurrence. In order to accompany breast cancer patients during this~     transition period and to address these emotional difficulties, the Institut Jules Bordet has~     launched an 8-session psychological multi-component group intervention. Its objective is to~     bring patients tools and competencies (e.g., hypnosis, treatment of intrusive thoughts,~     learning to cope with uncertainty, attention reorientation toward positive thoughts) to~     promote emotion management and well-being.~   "
17582|NCT03336814|"~     In guidelines norepinephrine is the first line vasopressor recommended in case of septic~     shock. Use of vasopressin is recommended when norepinephrine fails to maintain a mean~     arterial pressure above 65mmHg or in salvage. Several studies failed to show a superiority of~     vasopressin over norepinephrine but none evaluated the effect of an early association on~     organ failure. Terlipressin is a pro-drug of vasopressin which has the same vasoconstrictor~     effect. We hypothesize that the early association of terlipressin and norepinephrine during~     septic shock reduces organ failure.~      This bi centric, double-blinded, randomised, controlled versus placebo study includes 40~     patients. Randomisation will be stratified between centers (two university affiliated~     intensive care units of Assistance-Publique-Hôpitaux de Marseille, Marseille, France). All~     patients with septic shock needing more than 0,5µg/kg/min of norepinephrine to reach PAM~     objectives are randomised, after hemodynamic evaluation and optimisation, to receive~     continuous infusions of terlipressin (0,01mg/kg/min) or placebo (physiologic serum). The 2~     groups receive steroid therapy (continuous intravenous hydrocortisone perfusion) at this~     time. Clinicians are blinded of perfusion used. Use of terlipressin remains possible in~     salvage when patients need more of 1µg/kg/min of norepinephrine on physician's decision.~     Patients with acute ischemic or septic heart failure are excluded of the study.~      Primary objective is sepsis related Sequential Organ Failure Assessment (SOFA) score~     difference between the groups at day 3. Secondary objectives are mortality at day 28,~     lactates clearance in the first 48hours, renal function (evaluates with AKIN criteria) and~     use of renal replacement therapy.~   "
17584|NCT03336788|"~     Depression is a mood disorder affecting an individual in its entirety, altering its emotional~     and intellectual functioning . The major form of depression is the most common psychiatric~     disorder in Western countries. It is considered to be the most expensive psychiatric~     neurological disease in Europe and is currently treated by different methods.~      However, almost a third of depressed patients shows no clinical improvement. Advances in~     neuroscience and understanding of neuromodulation have enabled the emergence of new~     treatments such as the repetitive transcranial magnetic stimulation (rTMS) . It consists of~     modulating the neuronal activity of a targeted brain region through a magnetic field applied~     by a coil. Even though this form of treatment has proven to be effective, it appears that~     more than half of depressed patients exhibited little to no response to it.~      As brain regions targeted by TMS may also be stimulated beforehand by sensory afferent~     signals, it was hypothesized that optimizing the effects of TMS with virtual reality is~     possible through the activation of these brain regions with sensory stimuli holding emotional~     valence (images, sounds) while using TMS concomitantly. Based on this new research premise,~     the investigators propose, in the context of an open and controlled clinical trial, to use a~     new media entitled virtual reality for displaying interactive virtual environments with~     positive emotional valence ( field of flowers, green valley) to a group of depressed patients~     undergoing TMS at the same time.~      The study will include 66 depressed patients randomly assigned into two groups : TMS and~     Virtual Reality Versus TMS alone. Any differences in therapeutic efficacy between the two~     groups will be measured by questionnaires and brain functional imagery. This innovative and~     therapeutic approach will allow us to better understand the appropriate processes for~     modulating the neuronal activity in specific brain areas for treatment purposes.~   "
17585|NCT03336775|"~     Purpose:~      Rationale: Acupuncture is a therapy for physical activity disorders secondary to nervous~     diseases, and it may have therapeutic effects on dysphagia caused by radiation therapy.~      Purpose: This randomized trial aims to investigate whether acupuncture may alleviate~     radiation-induced dysphagia in patients with head and neck cancer. The effect was compared~     with outcomes in patients without receiving acupuncture.~   "
17586|NCT03336762|"~     ISCoPE-TM will use intra spinal monitoring techniques to assess cord perfusion and metabolism~     in patients with severe spinal cord damage from transverse myelitis~   "
17587|NCT03336749|"~     The overall aim of this study is to investigate if sensory re-learning in combination with~     task-specific training is more effective than task-specific training alone to improve sensory~     function of the hand, dexterity, the ability to use the hand in daily activities, perceived~     participation and life satisfaction.~   "
17588|NCT03336736|"~     This project focuses on the sub-group population with pulmonary sarcoidosis - a condition~     that causes red swollen tissue called granulomas to develop in organs such as the lungs. The~     condition is associated to symptoms of shortness of breath and a persistent dry cough. The~     aim of the research is to investigate the role of physical activity, exercise and diet within~     pulmonary sarcoidosis-related outcomes. Exercise has the potential to improve symptoms of~     pulmonary sarcoidosis including fatigue, dyspnoea, quality of life (QOL) and exercise~     tolerance. The use of exercise in symptomatic patients is supported by current evidence but~     is limited and requires further understanding, given the unique nature of the condition, in~     terms of physical and psychological outcomes. Specific dietary and exercise recommendations~     are limited by the lack of evidence for specific modifications such as the type(s),~     intensities, frequency and duration.~      The study will involve completion of validated questionnaires including quality of life (QOL;~     Sarcoidosis Health Questionnaire (SHQ) (see appendix III), the SHQ comprises of 29-item, 7~     point Likert scale questionnaire and fatigue (Fatigue Assessment Scale; FAS (see appendix IV)~     and will require participants to attend two visits to the Kingston University, Human~     Performance Lab at Penrhyn Rd campus, this is to ensure reliability and validity for the data~     collected. The visits will consist of a range of physical tests including lung function, a~     six-minute walk test and muscle strength tests. The primary aim of the study is to ascertain~     the physical activity patterns in those with pulmonary sarcoidosis with regards to perceived~     physical activity, measured using the the International Physical Activity Questionnaires~     (IPAQ) (appendix V), which comprises of 27 items across five activity domains and actual~     physical activity ,measured by tri-axial accelerometry, fatigue assessment scale (appendix~     IV). The secondary aim of the study is to understand the effect of pulmonary sarcoidosis in~     relation to muscle strength and exercise capacity against physical activity, lung function~     and oxygen saturation and how these differ from healthy normative values.~      Participants will be asked to read the participant information and declare consent before~     starting the study. Only the researcher and supervisors of the study will have access to the~     raw data. Anonymity will be kept all times.~   "
17589|NCT03336723|"~     2 Arms (60 subjects - 30 each arm). Experimental group with two-pice zirconia dental implant~     and Control group with two-piece titanium dental implant Evaluate Changes in inflammatory and~     microbiology levels from T0 (baseline) T2 (8 weeks) and T3 (after crown placement) Also~     evaluate secondary outcomes: marginal bone loss (MBL), gingival height (GH) levels,~     osseointegration, gender, age, time of surgery, anatomical position and implant stability. p~     values<0.05 were considered statistically significant~   "
17590|NCT03336710|"~     This project examines the psychological construct of decentering - a mindfulness-related~     construct marked by an observer perspective on one's ongoing mental processes. Specifically,~     this project seeks to explore the extent to which decentering modulates the relationship~     between people's affective states and their momentary mental health and well-being, and to~     test the psychological processes by which decentering might exert these effects. This study~     includes a baseline assessment followed by a 7-day study completed from home where~     participants respond to brief surveys about their current experiences six times per day~     (i.e., an Ecological Momentary Assessment [EMA] design).~      The investigators hypothesize that decentering moderates the association of extreme affect~     with related symptoms (i.e., elevated negative affect with depression and anxiety; elevated~     positive affect with mania, narcissism, and histrionic traits) and well-being, such that the~     association is attenuated at high levels of decentering. This will be examined using the EMA~     data, analyzing between-person levels (i.e., trait) as well as momentary within-person~     processes (i.e., concurrent and prospective states).~      Further, the investigators predict that broadened attentional focus and improved~     self-regulation are mechanisms that contribute to the beneficial effects of decentering in~     daily life. This hypothesis will be examined in two ways:~        1. as individual differences, wherein greater self-regulatory abilities (e.g., higher heart~          rate variability) and less attentional biases towards emotional stimuli mediate the~          association between trait decentering and subsequent daily well-being/symptoms, and~        2. as within-person momentary levels, wherein broader attentional processes and greater~          self-regulation in daily life mediate the concurrent and prospective association between~          momentary decentering and well-being/symptoms.~      Note that the study uses a multimodal assessment of each of the proposed processes. For~     attentional processes, a variety of parameters extracted from an emotional eye tracking~     paradigm will be examined. For self-regulatory abilities, assessments will include~     self-report, physiological (heart rate variability), and behavioral (go / no-go task)~     measures of such abilities.~   "
17591|NCT03336697|"~     The exact cause of PD remains unknown, but current theories suggest that it results from a~     combination of hereditary or genetic factors (i.e. family traits ) and exposure to unknown~     substances in the environment. The purpose of this study is to investigate whether toxins~     produced by bacteria that live within the nasal canal (nose) and the intestines of people~     with PD might have a role in causing the disease. The investigators in this study would like~     to look at the types of bacteria that live in the nasal canals and intestines of PD subjects~     and compare them with those of subjects who do not have PD.~   "
17592|NCT03336684|"~     Rheumatoid arthritis is an inflammatory disease that results in joint inflammation, pain and~     swelling. It may progress to advance stages that render patients unable to carry out their~     daily activities. It also results in joints deformity and is a leading cause of disability~     globally.~      Patient education plays an important role in the management of disease. Adequate patient~     knowledge and awareness about disease may help in incorporating the ailment in daily life.~     The purpose of this study is to evaluate the benefit of a disease education literature in~     Urdu language and with culturally relevant illustration for rheumatoid arthritis patients.~   "
17593|NCT03336671|"~     The objectives of this study would be to determine the most effective management for~     pediatric patients with chronic rhinosinusitis and asthma who fail medical management. The~     Sinus and Nasal Quality of Life Survey (SN-5), a validated tool, will be used to track~     symptoms of pediatric chronic rhinosinusitis. A decrease in at least 0.5 is felt to represent~     an improvement in symptom control. In this study, the SN-5 at one year post intervention will~     be the primary endpoint. Secondary endpoints include complications, revision surgery, and~     post operative endoscopy scores.~   "
17594|NCT03336658|"~     All the preoperative biopsies of patients suffering colorectal cancer (CRC) will be~     immunohistochemically stained with a pancytokeratin marker to detect Tumor buds. then, the~     intratumoral buds (ITB) in the densest Region of Tumor buds, namely the hot spot will be~     counted. Subsequently, the probability of N stage (lymphnodes), M stage (metastases) and~     disease free survival (DFS) will be calculated based on an existing logistic Regression model~     already developed by our previous retrospective work. Additionally, a Standardisation of ITB~     using a well- established Software will develop an algorithm which will help to eliminate~     inter- observer variability of Tumor budding Counts.~   "
17595|NCT03336645|"~     The purpose of this study is to assess the efficacy, safety and pharmacokinetics of~     MHOS/SHP615 administered buccally in children with status epilepticus (convulsive) in a~     healthcare setting.~   "
17596|NCT03336632|"~     This study is to explore the efficacy and safety of introduction of chidamide in PTCy based~     GVHD prophylaxis in patients undergoing allogeneic PBSCT.~   "
17597|NCT03336619|"~     Trial to evaluate efficacy and safety of nitazoxanide (NTZ) in the treatment of uncomplicated~     influenza.~   "
17598|NCT03336606|"~     This clinical trial will evaluate the safety and feasibility of a humanized OX40 agonist,~     MEDI0562, in the pre-operative setting for patients with head and neck squamous cell~     carcinoma or melanoma.~   "
17599|NCT03336593|"~     This study is to assess protectivity and safety of Quadrivalent Influenza Vaccine in~     Indonesian Population~   "
17600|NCT03336580|"~     A Phase 1, open-label, 3+3 dose escalation component to determine the safety, tolerability,~     PK, PD, and MTD of IV PRX004 when given as a single agent to up to 36 subjects with hATTR~     amyloidosis An expansion component in up to 2 anticipated PRX004 RP2D cohorts selected from~     dose escalation (up to an additional 3 subjects in each expanded cohort for up to 6 evaluable~     subjects total in each expanded cohort; an evaluable subject is defined as a subject who has~     completed the first 28 days following the first administration of PRX004 or who discontinued~     within 28 days due to study drug related toxicity). Subjects with wtATTR amyloidosis may be~     enrolled as part of the expansion component.~   "
17601|NCT03336567|"~     Gene and cell therapies have a real value potential (example: potential long-term effect,~     curative potential, and single administration) but also drawbacks (example: treatment~     perceived as complex and risky generating fear and anxiety in subjects and their family; high~     cost) that require significant educational efforts and planning for optimal market access. It~     is therefore important to understand subject and physician perceptions of T-Cell Receptor~     (TCR) therapies. The aim of this study is to collect qualitative data from a small but~     diverse sample of oncologists and subjects in the United States to gather qualitative~     evidence for a preliminary understanding about their perceptions of T-cell therapies in the~     treatment of cancer. This cross-sectional study will involve up to 20 adult subjects with~     cancer and up to 20 oncologists/hematologist-oncologists in the United States. Eligible~     subjects will be scheduled for a telephone interview lasting approximately 60-90 minutes.~     Eligible oncologists will be scheduled for a telephone interview lasting approximately 60~     minutes.~      Searching social media is another way of understanding the perceptions of prescribers and~     consumers of CGT, in addition to interviews being conducted under the original protocol. The~     results of a feasibility assessment suggested that it would be helpful to explore social~     media to add to the findings from the interviews. This social media study(SMS) is being~     conducted as a pilot study to hone methods for future explorations of social media. The pilot~     study will investigate and describe initial themes emerging from existing discussions related~     to CGT. Findings from this work will help GlaxoSmithKline to plan future work in the social~     media landscape.~   "
17602|NCT03336554|"~     hMe-Seal is a low-input whole-genome cell-free 5hmC sequencing method based on selective~     chemical labeling. It uses β-glucosyltransferase (βGT) to selectively label 5hmC with a~     biotin via an azide-modified glucose for pull-down of 5hmC-containing DNA fragments for~     sequencing. After selectively constructing 5hmC library, highthroughput-sequencing will be~     performed on an Illumina Nextseq-500 instrument. By ways of Rawdata processing, differential~     loci between Osteosarcoma group and control group will be detected to indentify specific~     epigenetic biomarkers of Osteosarcoma.~   "
17603|NCT03336541|"~     Postpartum depression is common in mothers early after childbirth and produces harmful~     effects not only on mothers, but also on infants and young children. Parturients with~     prenatal depression are at increased of postpartum depression. Low-dose ketamine can be used~     for antidepressant therapy. We hypothesize that low-dose ketamine has a therapeutic effect on~     parturients with prenatal depression. This study is designed to investigate whether low-dose~     ketamine administered during cesarean delivery can decrease the incidence of postpartum~     depression in parturients with prenatal depression.~   "
17604|NCT03336528|"~     The purpose of this study is to find out if treatment with Degludec insulin when compared to~     glargine U100 insulin will result in similar blood sugar control in patients with diabetes,~     who are admitted to the hospital and then transition at home, after discharge from the~     hospital.~   "
17605|NCT03336515|"~     The objective of the study is validity of the effectiveness of a vibrating postural device in~     reduce the respiratory events (Apnea-Hypopnea Index-AHI) in patients with positional~     Obstructive Sleep Apnea (OSA).~   "
17606|NCT03336502|"~     The purpose of this study is to evaluate the pharmacokinetics and safety of posaconazole~     intravenous solution in Chinese participants at high risk for invasive fungal infections.~     Neutropenic participants undergoing chemotherapy for acute myelogenous leukemia or~     myelodysplastic syndromes will be enrolled in the study.~   "
17670|NCT03335670|"~     This study will evaluate how Gallium-68 Pentixafor is distributed in neuroendocrine tumor~     patients and if that distribution is consistent through repeated scans. This is an RDRC study~     - as such, the images obtained for this study cannot be used clinically or shared with~     treating oncologists.~   "
17607|NCT03336489|"~     In Paris, France, home hospice care for terminally ill patients is organized by four~     palliative care networks. These networks are responsible for information sharing and~     coordination of all health care professionals working with the patient. Two different systems~     are in place to ensure continuity of care outside working hours, in such a setting. In the~     first system, palliative care specialists from the network are reachable over the phone 24/7~     by the patient or its caregivers, whenever needed. In the second system, medical information~     about the patient, regularly updated by the network's medical team, is available to~     professionals via a secure website, so that in case the patient requires an urgent medical~     home visit outside working hours, the visiting physician has access to accurate information.~      The study's goal is to compare patient's and caregiver's satisfaction between these two~     systems of continuity of care.~      For that purpose, patients will be taken care of as usual by every palliative care network.~     In every instance where the patient or caregivers have reached out for medical help through~     the network's continuity of care system, the patient or caregiver will be called 5 days later~     by the investigation team to go through a satisfaction questionnaire (Likert scales)~   "
17608|NCT03336476|"~     The use of videolarygoscopy (VL) as first choice for tracheal intubation versus direct~     laryngoscopy (DL) is a matter of debate. These two methods were compared in several studies.~     Videolaryngoscopes may reduce the number of failed intubations, particularly among patients~     presenting with a difficult airway. They improve the glottic view and may reduce airway~     trauma. DM is accepted as a risk factor for difficult intubation. The aim of this study is to~     compare VL to DL in adult patients requiring tracheal intubation for anesthesia, in terms of~     intubation success, glottic view quality, intubation failure, intubation time, conversion to~     another laringoscopy method and adverse outcomes related to tracheal intubation.~   "
17609|NCT03336463|"~     Recurrent pregnancy loss (RPL) is a clinical problem affecting 1-5% of couples of~     reproductive age. The contribution of thrombophilia to RPL is disputed. This controversy is~     partly due to low sensitivity of the genetic variants currently used to evaluate hereditary~     thrombophilia: the Leiden mutation (identified as rs6025) in the coagulation factor 5 (F5L)~     gene and mutation G20210A (identified as rs1799963) in the prothrombin (PT) gene.~      Our objective was to determine whether a wider algorithm that includes clinic and genetic~     variants associated with thrombophilia could be more useful in the prediction for RPL than~     FVL and PT alone.~   "
17610|NCT03336450|"~     The purpose of this study is to determine if the investigational treatment, MHOS/SHP615, is~     safe and effective in children with status epilepticus (SE) (convulsive) in the community~     setting. This study is open-label extension for patients who completed the SHP615-301 study~     and who tolerated and responded to MHOS/SHP615 treatment in the hospital setting.~   "
17611|NCT03336437|"~     This is a study of how local estrogen treatment affects the microbiome of the vagina and~     bladder in postmenopausal women experiencing symptoms as part of Genitourinary Syndrome of~     Menopause. The goal is to understand more about the underlying microbial changes occurring~     in menopause and whether these are reversible with estrogen.~   "
17612|NCT03336424|"~     The objective of the study is to describe the current status of MS patients with urinary~     disorders in Lebanon, and to demonstrate whether invasive investigations improve the~     management of these patients compared to an optimal non-invasive approach.~   "
17613|NCT03336411|"~     The aim of this 2-phase, randomized clinical trial will be to examine the effects of two~     behavioral weight loss interventions on weight loss. This study will be conducted in 200~     overweight or obese prediabetic individuals recruited from community-based settings.. Phase 1~     will include 6-months of active intervention. Phase 2 will consist of 6-months of maintenance~     and observation. Measurements will occur at screening, baseline, 3, 6, and 12 months.~     Participants will be randomized with equal allocation to 2 groups: (1) a standardized~     behavioral weight loss intervention with a one-size-fits-all regimen that includes counseling~     about restriction of calories and calories from fat, and physical activity, delivered using~     mHealth technology, or (2) all of the elements of mHealth, plus personalized dietary~     recommendations to minimize glycemic response to meals. Participants will be required to~     attend 6 separate visits over both phases of the study.~   "
17614|NCT03336398|"~     Tinnitus, or ringing in the ears, is a very common problem that often accompanies hearing~     loss. It affects up to 1 in 10 adults, and about 30% of people who experience chronic~     tinnitus find it very distressing. In these patients, symptoms of depression and anxiety~     often accompany tinnitus and there are no approved treatments. Clinical trials are ongoing to~     test a glutamate NMDA receptor antagonist (called esketamine), which is injected into the~     inner ear. However, the preliminary results with this medication show that it only works for~     tinnitus that results from acute injury. It does not treat tinnitus resulting from~     progressive hearing loss.~      Research in humans and animals suggest that the neurotransmitters glutamate and GABA are~     important in the development and maintenance of tinnitus. This data shows that~     over-activation of the NMDA receptor and a decrease in GABA signaling in the brain play a~     crucial role. Previous studies show that ketamine, which an antagonist at the NMDA receptor,~     increases GABA levels in the brain in participants with depression. Thus, in this experiment,~     this study will test the effect of ketamine on tinnitus, since it blocks the NMDA glutamate~     receptor and increase GABA levels.~      Two groups of participants will be included in this study: those who experience distress~     (symptoms of anxiety or depression) with tinnitus and those who have tinnitus but do not~     experience distress. Each participant will receive both ketamine and placebo on different~     days. Magnetic Resonance Spectroscopy (MRS) scans will be~   "
17615|NCT03336385|"~     The investigators aim was to assess whether 6 weeks of oral intake of the wheat-derived~     prebiotic fiber arabinoxylan or oat-derived beta-glucan could improve intestinal barrier~     function against drug-induced barrier disruption in a general population of elderly people,~     in a randomized double blinded placebo-controlled clinical trial.~   "
17616|NCT03336372|"~     Patients at least 18 years of age will be enrolled in the study to assess the efficacy and~     tolerability of Picato gel in the treatment of molluscum contagiosum. Patients must have an~     immunocompromised condition due to taking immunosuppressive drugs or having an inherited~     disease affecting the immune system.~   "
23800|NCT03255421|"~     This study evaluate the feasibility and the accuracy of an emptying cystometry in order to~     simplify the manometric follow-up of overactive detrusor in neurological patients under~     anticholinergic or botulinum toxin injections.~   "
17617|NCT03336359|"~     This is a prospective randomized trial comparing the adenoma detection rate of LCI with NBI.~     Eligible patients are randomly allocated in a 1:1 ratio to undergo tandem colonoscopy with~     LCI (LCI group) or NBI (NBI group). Randomization will be carried out by computer generated~     random sequences and stratified according to endoscopist's experiences (experienced versus~     fellows) and indications of colonoscopy (symptomatic vs screening/surveillance).~      The primary outcome of this study is to compare the adenoma or polyp detection rates by LCI~     and NBI during the first examination. Secondary outcomes included adenoma/polyp miss rate by~     LCI or NBI. Other outcomes include sessile serrated adenomas or polyps (SSA/P) detection~     rates and advanced adenoma detection rates.~   "
17618|NCT03336346|"~     The primary aim is to assess if etonogestrel (ENG) implant users taking dolutegravir (DTG)~     have a 20% or greater change in their ENG plasma levels, compared to women taking no~     antiretroviral therapy (ART). A secondary aim is to assess whether ENG implant users taking~     dolutegravir have significantly higher ENG plasma levels than ENG implant users taking~     efavirenz.~      This is a cross-sectional, non-randomized evaluation to compare ENG levels at least 3 months~     post-implant insertion in three groups of women: 1) women using DTG-based ART (n=90), 2)~     women using EFV-based ART (n=90), and 3) women using no ART (not HIV infected) (n=90). This~     study will be conducted in Botswana in Southern Africa among women using the ENG implant, and~     involves a one-time collection of blood and questionnaire.~   "
17619|NCT03336333|"~     This study will enroll subjects with previously untreated CLL/SLL into two cohorts (Cohort 1~     without del[17p] and Cohort 2 with del[17p]). Cohort 1 subjects will receive either BGB-3111~     alone or bendamustine (B) and rituximab (R). Cohort 2 subjects will receive BGB-3111~     alone. The primary purpose is to evaluate the efficacy and safety of BGB-3111 versus~     bendamustine and rituximab in Cohort 1.~   "
17620|NCT03336320|"~     The primary purpose of the protocol is to evaluate the feasibility and acceptability of a~     home-based (using information and communication technologies) intervention composed of~     nutritional conselling, exercise and cognitive training in older adults and its potential~     effect on various health outcomes.~   "
17621|NCT03336307|"~     Patients with Parkinson's disease show a gait disturbance which is considered as one of the~     most disabling aspect of the disease that strongly impacts on patients' autonomy and quality~     of life. The mechanism underlying gait impairment is multi-factorial, reflects the global~     motor impairment of patients with PD and is mainly related to a neurotransmitter deficiency~     inducing bradykinesia, rigidity, abnormal trunk control and postural instability. For this~     reason, and considering the impact of social and economic costs, one of the main foci of~     intervention in patients with PD should be treating gait abnormalities. This need is further~     reinforced by the knowledge that gait outcomes are correlated with longevity, cognitive~     decline and adverse events.~      Besides the shorten-step gait clinical description of the gait disorder in PD, in the last~     years, studies using modern 3D motion analysis systems have further detailed the gait pattern~     in PD disclosing abnormalities in cadence, stance duration, swing duration, double support~     duration, leg length, step length, velocity, hip, knee and ankle ROMs. Such abnormal gait~     parameters seem to correlate with the clinical outcomes of UPDRS score, H-Y stage and~     milliequivalents of levodopa taken. Importantly, gait parameters can either normalize or~     improve after several rehabilitative treatment strategies including physiotherapy, assistive~     equipment, sensory cueing, treadmill training, physical activity, home base exercises.~     However, none of the previous studies specifically investigated which biomechanical factor~     can be modified after rehabilitation and which clinical characteristic can predict the~     rehabilitation-induced gait improvement. This would be extremely important to typifying,~     grouping and selecting patients, optimizing the rehabilitative strategies and cost~     management.~      The aims of the present study were to evaluate in a sample of patients with PD: i) which gait~     parameters can be modified after a short-term rehabilitation program; ii) which, if any,~     clinical variable can predict the improvement of the gait function after rehabilitation. At~     this aim we quantitatively evaluated the gait performance of PD patients by means of a 3-D~     motion analysis system.~   "
17622|NCT03336294|"~     P31 nuclear magnetic resonance (RMN) Spectroscopy (SRM P31) has currently being poorly used~     in the field of sarcopenia.~      The aim of the CAMUS study is to investigate the feasibility a protocol of SRM P31 at rest,~     during and after a standardized physical task. The secondary objective is to compare the~     metabolism of tyhe skeletal muscle tissue assessed by SRM P31 in young and older individuals.~     A pilot study, cross-sectional study will be conducted. Ten healthy sedentary 70+ years males~     and 10 sedentary 25 to 30 years old male will be included.~      Level of physical activity, physical performances, will be assessed at baseline. RMN (T1;~     tractography and SRM P31) will be performed. SRM P31 will be performed at rest, during and~     after an exhausting muscle task at 70% 1-RM. Feasibility will be judged on the rate of~     valuable variables recorded (>90%) inorganic phosphate (iP), phosphocreatine (PCr) and~     isoform of adenosine triphosphate (ATP : alfa, beta, gamma).~   "
17623|NCT03336281|"~     The primary purpose of this study is to describe the Psoriatic Arthritis (PsA) participant~     profiles depending on whether their disease is managed by a dermatologist or by a~     rheumatologist in routine practice.~   "
17624|NCT03336268|"~     The investigators seek to assess the effectiveness of Project POINT (Planned Outreach,~     Intervention, Naloxone, and Treatment). Located in Indianapolis, Project POINT is a~     collaboration between Indianapolis Emergency Medical Services (EMS), the Eskenazi Emergency~     Department, Midtown Mental Health, and researchers at Indiana University. POINT is a quality~     improvement initiative that connects trained outreach workers with emergency department (ED)~     patients who experienced a non-fatal overdose. A member of the POINT team (a recovery coach~     or care coordinator with specialized training) meets patients after they have experienced an~     opioid overdose and, following a model of patient-centered care, offers them a range of~     evidence-based services including a brief assessment of high-risk behaviors, Hepatitis C and~     HIV testing, harm reduction counseling informed by motivational interviewing,and treatment~     referrals with follow-up to either a medication assisted treatment (MAT) provider,~     detoxification services, or an inpatient treatment setting~      The primary goal of this project is the establishment of POINT as an effective and scalable~     intervention for engaging patients in MAT. This study employs a Hybrid Type 1 effectiveness~     implementation design to take full advantage of current POINT expansion efforts currently~     happening in Indiana.The goal of this pilot study is to replicate POINT in a new hospital and~     test its feasibility through (a) assessment of the chosen implementation strategy and (b) the~     testing of research protocols and secondary data collection procedures.~   "
17671|NCT03335657|"~     The goal of the CBPT study is to determine the efficacy of the CBPT program for improving~     outcomes in service members and civilians at-risk for poor outcomes following traumatic~     lower-extremity injury. Primary outcome is physical function measured through a~     patient-reported questionnaire and physical performance tests. Secondary outcomes include~     pain and general health. Tertiary outcome is return to work/duty.~   "
17625|NCT03336255|"~     Research show that South Asians (SA) have a high burden of Cardio Vascular Disease (CVD) risk~     factors of which, poor diet and physical inactivity remain the major lifestyle risk factors~     in SA. Intensive diet and physical activity behavioral interventions have been shown to yield~     improvements across a variety of intermediate cardiovascular health outcomes (blood pressure,~     cholesterol, glycated hemoglobin, weight) in persons with CVD risk factors and are~     recommended by national guidelines. However, the investigators prior research found that~     existing interventions are not reaching SA. First, the usual framing of behavioral risk~     factor interventions in terms of the biomedical model of CVD is mismatched to SA explanatory~     models, which emphasize psychosocial causes of CVD. Next, few interventions are tailored to~     the sociocultural patterns shared by much of the SA community. Interventions that address the~     individual and shared sociocultural drivers of CVD risk are needed to maximize reach and~     effectiveness in the high risk and rapidly growing SA population. The proposed study builds~     on the strong foundation of the South Asian Healthy Lifestyle Initiative (SAHELI), which has~     a 9-year history of using community-based participatory research to design and test~     culturally tailored, community-based interventions to reduce CVD disparities in SA. To date,~     SAHELI has engaged multi-sectoral partners, established relationships of trust, and defined~     mutually beneficial goals. The investigators also culturally adapted the SAHELI lifestyle~     intervention to (a) address the individual and sociocultural determinants of CVD risk in SA;~     and (b) increase components of self-regulation (motivation, self-monitoring, goal setting)~     that are most effective in eliciting diet and physical activity changes.Hence, the SAHELI~     intervention integrates evidence-based behavior change techniques with the shared the~     sociocultural processes salient to SA. A pilot study (n=63) established feasibility of the~     SAHELI intervention, had a 100% retention rate, and reduced glycated hemoglobin and weight~     among intervention participants compared to a control group. Based on this preliminary~     evidence of efficacy and a process evaluation, the investigators modified select components~     of the intervention for the proposed trial. Study team increased the intervention contact~     hours, piloted additional diet and exercise content, and included family. The proposed study~     will use a hybrid trial type 1 design to evaluate the clinical effectiveness and~     implementation potential of the culturally tailored, community-based lifestyle intervention~     in a larger, more generalizable at-risk SA population. Study team is uniquely positioned to~     fill a critical gap in work (a) demonstrating the cultural adaptation of evidence-based~     lifestyle interventions, and (b) evaluating the effectiveness of the SAHELI intervention in~     reducing CVD risk in SA living in the U.S.~   "
17626|NCT03336242|"~     The primary purpose of this study is to assess the efficacy of Cannabidiol Oral Solution in~     the treatment of pediatric participants with treatment-resistant childhood absence seizures.~     This study will also assess safety, tolerability and pharmacokinetics of Cannabidiol Oral~     Solution, and any improvement in qualitative assessments of participant status over the~     duration of the study in pediatric participants with treatment-resistant childhood absence~     seizures. The study will include a 4-week Screening Period, a 5 or 10 day Titration Period~     (depending study Cohort), a 4-week Treatment Period followed by 5-day Tapering for doses >20~     mg/kg/day and a 4-week Follow-up Period.~   "
17627|NCT03336229|"~     This study examines whether a home-based telephone-guided preoperative exercise programme is~     feasible and effective in improving cardiorespiratory fitness in patients with colorectal~     cancer who are high risk due to their existing co-morbidity.~   "
17628|NCT03336216|"~     The purpose of this study is to determine whether an investigational immuno-therapy,~     cabiralizumab in combination with nivolumab, with or without chemotherapy, is effective for~     the treatment of advanced pancreatic cancer.~   "
17629|NCT03336203|"~     This trial aims to investigate the impact of two target levels uric acid-lowering therapy~     (ULT) caused by hyperuricemia (HU) on kidney function and CKD progression [1] measured by~     eGFR and albuminuria (A) [2].~      The main current tasks include 1) estimation serum uric acid (SUA) level most potential~     preserving of kidney function 2) the new onset of gouts depending on SUA level, both in~     gouts' and CKD' objects 3) safety and side effects of target and ultralow SUA levels for~     evidence-based ULT optimal regime in CKD and non CKD with gout patients. 4) investigation of~     cardio vascular rick ratio depending on SUA level.~      The tasks also include~        1. to determine U-curve or directly proportional relationship between SUA and eGFR-EPI in~          CKD 1-4~        2. to evaluate the new onset of goat which depends on SUA level and renal function In this~          study the optimal ULT for kidney function based on target SUA level in 30 months'~          treatment with either allopurinol or febuxostat will be determined.~   "
17630|NCT03336190|"~     The purpose of this project is to evaluate an interactive training program for~     military-connected caregivers (MCCs) of wounded warriors. The program leverages existing~     resources and incorporates evidence-based training and peer-based support networks to enhance~     continuity of care. The program consists of an educational Toolkit (workbook) and an avatar~     training interaction where an MCC can practice skills learned from the toolkit training with~     the avatar (how to navigate difficult conversations). This is an educational training~     evaluation to determine whether or not avatar interaction can effectively improve health~     outcomes in MCCs.~   "
17631|NCT03336177|"~     Systematic screening for cervical cancer stops in France at 65 years old. The incidence of~     certain types of gynecological neoplasia increases with age (endometrium, vulva). Diagnosis~     delay of 8 months has been described for uterine cancer and longer delays for vulvar cancer.~      The aim of our study is to understand help-seeking behavior and its delay for this type of~     cancer among patients older than 65.~   "
17632|NCT03336164|"~     This study evaluates the impact of the introduction of a front-of-pack nutrition label on~     foods and beverages sold in a campus university restaurant in France on the nutritional~     quality of purchases.~   "
17633|NCT03336151|"~     This study evaluates the impact of the introduction of a front-of-pack nutrition label on~     foods and beverages sold in a campus cafeteria in France on the nutritional quality of~     purchases.~   "
17634|NCT03336138|"~     The purpose of this study is to evaluate the value of AMA in a comparative multicenter~     regional study as a reference for aggressive lymphoma. The primary endpoint will be RDI. This~     study consider that the AMA support should allow a significant improvement of the RDI~     compared to the control group and thus impact the duration without progression. The study~     covers 350 patients recruited from 10 regional centers.~   "
17635|NCT03336125|"~     The purpose of the project is to investigate whether an intervention program with vitamin D~     supplementation is able to improve the biology of stress resilience as well as subjective~     well-being in individuals with antisocial behavior problems (forensic inpatients).~   "
17672|NCT03335644|"~     The NutriNet-Santé study was set up to investigate nutrition and health relationships.~     Specifically, it was the first web-based cohort worldwide on such a large scale (n=160 000 as~     of 2017) focused on the complex link between nutrition and health status. It is characterized~     by a very detailed assessment of nutritional exposure and dietary behavior.~   "
17704|NCT03335228|"~     The primary objective of this study is to assess the efficacy and safety of platelet rich~     plasma in reducing scalp symptoms and promoting hair growth in patients diagnosed with~     frontal fibrosing alopecia. Platelet rich plasma is an autologous blood product, and platelet~     rich plasma will be administered intralesionally for this study. The platelet rich plasma~     used for this study will be prepared using the Eclipse Easy Spin centrifuge.~   "
17636|NCT03336112|"~     Non-cardiac chest pain (NCCP) is common and has substantial impact on patients' psychological~     wellbeing, quality of life and healthcare use. Although cardiac diagnosis is 'ruled out',~     many patients think they have an undetected cardiac disease (i.e. they suffer cardiac~     anxiety) as no other explanation is offered. They therefore avoid activities that they~     believe might be harmful to their heart, leading to greater ill-health, and increased~     healthcare use and societal costs. Targeting cardiac anxiety with psychological interventions~     might break this vicious circle and improve patient outcomes. Patients need to evaluate the~     way they perceive and handle their chest pain, which can be done with cognitive behavioral~     therapy (CBT).~      The aim of this study is therefore to evaluate the short- and long-term effects of an~     Internet-delivered CBT (I-CBT) program on psychological distress and other patient-reported~     outcomes in patients with NCCP. A second aim is to explore factors related to implementation~     of I-CBT in clinical care. The study has a randomized controlled design comparing I-CBT with~     Internet-delivered information program. Quantitative methods will be used to evaluate the~     effectiveness of the I-CBT program. Implementation issues will be evaluated from the~     perspectives of patients, healthcare professionals and policymakers using qualitative~     methods.~   "
17637|NCT03336099|"~     Assessment of the effect of spa treatment on the functional severity of arthrosis.~      Official title: Evolution of clinical state of patients with rheumatic disease on lower limbs~     or rachis, 6 months after spa treatment.~      Primary outcome measure:~        -  Measuring the effect of spa treatment on functional severity of arthrosis~             -  Proportion of patients with a WOMAC score augmented by 9 or more, 6 months after~               enrollment (minimal clinically important difference)~      Secondary outcome measures~        -  Quantitative evaluation of pain~             -  Comparison of mean Visual Analogue Scale (VAS) pain scale between enrollment and 6~               months after~        -  Quantitative evaluation of WOMAC~             -  Comparison of mean WOMAC between enrollment and 6 months after~        -  Impact of spa treatment on the patient's metabolism~             -  Height and Weight (BMI calculation)~             -  Blood pressure~             -  Heart rate~        -  Quality of life~             -  36-Item Short Form (SF36) at enrollment, 3 months and 6 months~             -  EuroQol 5 Dimensions (EQ5D) questionnaire at enrollment, 3 months and 6 months~        -  Opinion of doctor and patient~             -  Semi-quantitative scale collected at enrollment, 3 months and 6 months~        -  Treatment follow-up~        -  Self-evaluation of pain~             -  Self-evaluation of pain with VAS pain scale every 6 week~   "
17638|NCT03336086|"~     This study included two groups of premenopausal healthy obese women. Experimental group~     underwent a weight loss program involved a low calorie diet plus anti-obesity drugs and~     moderate physical activity and control group underwent an ad libitum diet. At baseline and~     after a 10-15% weight loss lymphocyte subgroups were analyzed and compared between two group.~   "
17639|NCT03336073|"~     This is a multicenter, open label, phase II randomized controlled study that will evaluate~     the efficacy of carfilzomib and dexamethasone in combination with cyclophosphamide in R/R MM~     patients.~      For this purpose, R/R MM patients that have received 1-3 prior lines of therapy, and who are~     not primary refractory or refractory to proteasome inhibitors will be randomized to receive:~        -  Experimental arm: carfilzomib at a dose of 70 mg/m2 (20 mg/m2 only in the first~          infusion) intravenously (iv) on days 1, 8, and 15, dexamethasone by mouth (po) at a dose~          of 20 mg (10 mg for patients >75 years) days 1, 2, 8, 9, 15 and 16 and cyclophosphamide~          at a dose of 300 mg/m2 iv on days 1, 8 and 15, in 28 days cycles; or~        -  Control arm: the same treatment but without cyclophosphamide. Patients older than 75~          years will receive in both arms carfilzomib at a dose of 56 mg/m2 (20 mg/m2 only in the~          first infusion) during the cycles 1 and 2.~      If tolerability is acceptable, the dose could be increased up to 70 mg/m2 since the cycle 3.~      Treatment will be continued until progression, unacceptable toxicity or investigator or~     patient decision.~   "
17640|NCT03336060|"~     To examine the long-term effects of anterior cruciate ligament injuries and reconstructions~     (after successful rehabilitation) on cortical processes of motor planning during complex jump~     landing tasks and the relevance of cognitive performance measures for landing stability,~     respectively knee injury risk.~   "
17641|NCT03336047|"~     A high physical fitness can prevent cardiovascular disease. Which form of exercise training~     is efficient at improving fitness is well known. The challenge is to get people to do it.~     Personal activity intelligence (PAI) is an algorithm developed for this challenge. It gives a~     score that tells the users whether they are active enough to achieve the maximum health~     benefit of exercise based on their heart rate. It has been shown that people who obtain 100~     PAI a week have less cardiovascular disease, but intervention studies showing that PAI can~     improve physical fitness are so far lacking.~      Step counters have received a lot of attention and 10 000 steps a day is a common~     recommendation, but little is known about the physiological adaptations to this intervention.~      This study will compare the effect of physical activity with a value of 100 PAI points a week~     with 10 000 steps a day in healthy, but overweight (body mass index > 25) participants~     between 30 and 50 years of age.~   "
17642|NCT03336034|"~     Reliable evaluation of symptoms and their improvement during treatment is crucial in both~     diagnosing and evaluating response to treatment in IBS. Currently used end-of-day evaluations~     are considered sub-optimal and the Experience Sampling Method (ESM) was proposed previously~     as a more accurate symptom assessment method. Aim of this study is to evaluate the~     responsiveness of the developed ESM-PROM in assessing changes in abdominal pain and stool~     frequency after linaclotide treatment of IBS-C patients.~   "
17643|NCT03336021|"~     This project seeks to evaluate the impact of two USAID-funded projects that are implemented~     in rural Upper Egypt. The first project is the Feed the Future Egypt, Food-Security and~     Agribusiness Support (FAS) project; the second project is the Improving Maternal, Child~     Health, and Nutrition Services (IMCHN) project.~      The specific study objectives are (1) to estimate the impact of FAS interventions on project~     outcome indicators—especially on household income (measured by total household expenditure),~     household food security, and maternal and child nutrition—among farm households; (2) to~     estimate the effects of IMCHN interventions on maternal and child health and nutrition~     knowledge among community health workers (CHWs) and among farm households; and (3) to~     analytically explore potential synergistic effects of FAS and IMCHN interventions on maternal~     and child nutrition among farm households being exposed to both projects.~   "
17644|NCT03336008|"~     Spinocerebellar ataxias (SCA) 1, 2, 3 and 6 are the most common, autosomal dominantly~     inherited cerebellar degenerations. And in the Chinese population, the most common SCA is~     SCA3 and the frequency of SCA 3 among SCA patients is 72.5%, followed by SCA 2 that the~     frequency is 12% among SCA patients. For SCA 1, the frequency among SCA patients is 7%. Even~     SCAs are rare diseases, a significant amount of Chinese in Hong Kong still suffer from this~     disorders. SCA Association in Hong Kong has 88 members who are suffering from spinocerebellar~     degeneration, many of them have a genetic confirmation. As there are few treatments for SCAs;~     therefore, understanding SCAs clinical manifestation and disease mechanisms are the first~     step towards development of effective treatment. The objective of this study is to develop~     the first SCA registry in Hong Kong with bio-repository bank for clinical and genetic~     information as well as serum and fibroblasts.~   "
17645|NCT03335995|"~     The S.P.I.C.E registry is an investigator-initiated prospective multicenter cohort study~     which will be conducted in 35 ICUS in the Paris area.The aim of the study is to determine the~     trajectory of acute stroke patients requiring invasive mechanical ventilation, focusing on~     functional outcomes at 3 months and 1 year following ICU admission. This project is funded by~     the French Agence Régionale de Santé (ARS).~   "
17646|NCT03335982|"~     A transendoscopic enteral tubing (TET ) tube was inserted into mid-gut through the nasal~     orifice and fixed on the pylorus wall by one tiny titanium endoscopic clip under anesthesia.~     This study aimed to evaluate the feasibility and safety of TET in mid-gut .~   "
17647|NCT03335969|"~     To assess the safety and clinical effectiveness of using the FDA cleared HyGIeaCare System to~     relieve constipation in patients not responding to standard laxative treatment. Each patient~     will serve as their own control by comparing their bowel habits in a diary 4 weeks prior to~     colon irrigation to the bowel habits in their diary 4 weeks post colon irrigation.~   "
17648|NCT03335956|"~     This initial Phase I study will evaluate the dose-related safety and tolerability~     pharmacokinetics (PK) of CORT125281, and CORT125324 (active metabolite), and pharmacodynamics~     (PD) after single and multiple ascending oral doses of CORT125281 in healthy subjects.~   "
17649|NCT03335943|"~     This Study aims to evaluate the efficacy and safety of CDA-2 in the treatment of~     International Prognostic Scoring System (IPSS) Lower/Intermediate-risk myelodysplastic~     syndrome (MDS) in Chinese patients.~   "
17650|NCT03335930|"~     Exercise is recommended for type 2 diabetes, which is a global health problem. However,~     during a moderate-intensity exercise training there is an unpredictable risk of hypoglycemia~     for patients with type 2 diabetes. Therefore, the investigators aim to explore trends in~     blood glucose levels in response to a 12-week moderate-intensity exercise training in~     patients with type 2 diabetes and to explore the predictors of post-exercise blood glucose~     (PEBG) and exercise-induced glucose response (EIGR). A descriptive and longitudinal design~     was conducted. Eligible type 2 diabetes patients were recruited from outpatient clinics of a~     medical center in Taiwan and invited to participate in a 12-week moderate-intensity~     exercise-training program. Each participant received 36 repeated measures of blood glucose~     during the exercise training program. Participants were randomly assigned to one of three~     exercise times (morning/afternoon/evening). Each exercise session was took place 1 to 2 hours~     after a meal. Capillary blood glucose levels were measured pre- and post-exercise. The EIGR~     was calculated from subtracting the PEBG from the before-exercise blood glucose (BEBG).~     Generalized estimating equation was used to examine the trends and predictors of PEBG and~     EIGR.~   "
17651|NCT03335917|"~     1) Oxygen Transport in Normobaric versus Hypobaric Hypoxia. 2) The purpose of this study is~     to examine acute responses in arterial and muscle tissue oxygenation during incremental~     exercise in normobaric versus hypobaric hypoxia. 3) The participants in this study will~     consist of 12 recreationally active males and females between the ages of 19 and~     45.Recreationally active is defined as participating in moderate to vigorous physical~     activity for 30 minutes at least 3 days per week.4) Subjects will complete an incremental~     cycle test to volitional fatigue in three conditions in a randomized counter-balanced order,~     normobaric normoxia (20.9% O2, 730 mmHg), normobaric hypoxia (14.3% O2, 730 mmHg) and~     hypobaric hypoxia (20.9% O2, 530mmHg). Two of the three trials will be conducted in an~     environmental chamber to simulate normobaric normoxia at 350 m (elevation of Omaha, NE) and~     normobaric hypoxia at 3094 m (elevation of Leadville, CO). The hypobaric hypoxia trial will~     be conducted in Leadville, Colorado at 3094 m. Trials will be separated by at least two days.~     Rating of perceived exertion, heart rate, blood oxygenation, respiration rate, muscle tissue~     oxygenation, and whole body gases will be analyzed during the trials. 5) There is no~     follow-up as a part of this study.~   "
17652|NCT03335904|"~     Sleep disordered breathing (SDB) is characterized by regular periods of no breathing (apnea)~     or low levels of breathing (hypopnea) and leads to repeated periods of low oxygenation,~     termed intermittent hypoxia that causes fluctuations in blood oxygen levels. This leads to~     increased peripheral chemoreflex sensitivity that is thought to occur through the stimulation~     of angiotensin-II, type-I receptors (AT1R) that are expressed primarily on glomus cells~     within the peripheral chemoreflex and ultimately results in long lasting hypertension. The~     goal of this study is to determine if AT1R receptor blockade can prevent the increase in~     chemoreflex sensitivity following one night of hypoxia and improve the severity of SDB.~   "
17653|NCT03335891|"~     Objective: To investigate the effectiveness of core stabilization exercises combined with the~     patient education program (AEP) and breathing exercises in patients with asthma.~      Design: A randomized controlled study Setting: Chest diseases clinic of a university~     hospital. Subjects: The study sample consists of 26-68 years old asthma patients who were~     diagnosed at least 6 month prior to the study.~      Interventions: All subjects were included in the asthma education program (AEP) and both~     groups were trained for diaphragmatic and pursed lip breathing exercises (2times/wk. 6-week~     duration at clinic). The core stabilization program was applied twice a week for a duration~     of 6 weeks in TG.~      Main Measures: Spirometry, maximum inspiratory pressure (MIP) and maximum expiratory pressure~     (MEP), International Physical Activity Questionnaire Short Form (IPAQ), Hospital Anxiety and~     Depression Scale(HADS), Asthma Quality of Life Questionnaire(AQOL), Six-minute walking~     test(6MWT), Prokin PK200, Italy were used to evaluate feasibility of interventions.~   "
17744|NCT03334708|"~     The purpose of this study is to develop a minimally invasive test to diagnose pancreatic~     cancer at early stages of disease and monitor response to treatment.~   "
17654|NCT03335878|"~     Type 1 diabetes mellitus (T1DM) is typically diagnosed in childhood and over time can lead to~     complications affecting the retina, heart, kidneys, peripheral nerves, and more recently~     appreciated, the brain. Studies consistently find that early age of onset and, to a more~     variable extent, poor glycemic control over years are associated with reduced cognitive~     performance and altered brain structure in children with T1DM. As yet, the investigators'~     understanding of why early age of onset would pose more risks for the brain is limited,~     making interventions difficult to develop. Given that the initial clinical presentation of~     T1DM in children is the earliest and often the most severe glycemic state experienced over~     the lifetime, it is possible that age of onset and severity of initial clinical presentation~     interact to modify risks for brain health and development. This hypothesis has clear clinical~     implications and the potential to resolve conflicting literature, yet has not been explicitly~     tested. Thus, the goal of this study is to determine how clinical features at the time of~     T1DM diagnosis, such as hyperglycemia, diabetic ketoacidosis (DKA) and degree of beta cell~     failure, interact with age of onset to shape the development of the brain and its responses~     to subsequent glycemic control.~   "
17655|NCT03335865|"~     The purpose of this study is to assess the feasibility of measuring urine oxygen tension in~     cardiac surgery patient and the ability of peri-operative urine oxygen measurements to~     predict post-operative acute kidney injury. The hypothesis is that a small oxymeter placed in~     a urinary catheter will provide reliable measurement of urine oxygenation and that these~     measurements will predict post-operative acute kidney injury in cardiac surgery patients.~   "
17656|NCT03335852|"~     This study will evaluate the safety and to characterize the systemic pharmacokinetics of free~     and vascular endothelial growth factor (VEGF)-bound abicipar following multiple monthly~     intravitreal injections of abicipar in Japanese patients with neovascular age-related macular~     degeneration (AMD).~   "
17657|NCT03335839|"~     STRIVE will evaluate the use of adjunctive, low-dose intracoronary tissue plasminogen~     activator during primary percutaneous coronary intervention (PCI) for patients with ST~     elevation myocardial infarction (STEMI) in reducing major adverse cardiovascular events.~   "
17658|NCT03335826|"~     Surgical resection is one of the most important treatments for solid organ cancer. Whereas~     cancer recurrence and/or metastasis are the major reasons of treatment failure. The outcomes~     after surgery are mainly dependent on the balance between the immune function of the body and~     the invasiveness of cancer. Preclinical and retrospective studies suggest that anaesthetic~     techniques and drugs may affect the long-term outcomes in patients undergoing cancer surgery.~     The investigators hypothesize that epidural anesthesia-analgesia may improve long-term~     survival in the elderly who undergo major surgery for cancer.~   "
17659|NCT03335813|"~     Depending upon the cancer stage, esophageal cancer can be treated with surgery, chemotherapy,~     radiation therapy, or a combination of these modalities. Sometimes in addition to external~     radiation therapy or instead of external radiation therapy, select patients with esophageal~     cancer may benefit from localized radiation to the tumor, called esophageal brachytherapy.~     There are many different radiation techniques and delivery approaches for this type of~     specialized radiation therapy, and the purpose of this document is to provide a written~     summary of an innovative delivery method.~   "
17660|NCT03335800|"~     The Apple Heart Study (AHS) is a research study conducted to evaluate whether the Apple Heart~     Study App can use data collected on the Apple Watch to identify irregular heart rhythms,~     including those from potentially serious heart conditions such as atrial fibrillation. Up to~     500,000 can participate in the study.~   "
17661|NCT03335787|"~     The aim of this study is to investigate the long term effects of Kinesio taping applied on~     ankle and peroneal muscle in patients with stroke.~   "
17662|NCT03335774|"~     A randomized, double-blind, placebo-controlled, multicenter, parallel group study of the~     safety and efficacy of Hydrocortisone Acetate Suppositories, 25 mg compared to placebo~     suppositories in the treatment of symptomatic internal hemorrhoids.~   "
17663|NCT03335761|"~     This feasibility study will explore the effects of three different InterStim amplitude~     settings on overactive bladder symptoms (OAB).~   "
17664|NCT03335748|"~     The primary objective of this study was to examine the effects of the Cogmed training program~     on working memory among youths 7 to 13 years old, while controlling presence and presentation~     of ADHD-related comorbidity. A secondary objective was to examine the generalization of~     effects to ADHD symptoms, non-verbal reasoning, attentional and executive functions, motor~     impulsivity, reading comprehension, and mathematical reasoning. Participants were under~     pharmacological treatment for ADHD combined type and a comorbidity. They were randomized into~     an experimental group that received the Cogmed program and an active control group that~     received a low-intensity comparison version of the training. They were evaluated at three~     time points: six weeks prior to intervention onset (T1), immediately prior to onset(T2), and~     one week following intervention completion (T3).~   "
17665|NCT03335735|"~     This project aims to demonstrate the feasibility of a scalable behavioral intervention using~     smartphone-paired breathalyzers and text message aimed at reducing drinking and driving among~     individuals who report heavy drinking. All participants receive a smartphone breathalyzer to~     provide feedback on their estimated blood alcohol level. The intervention compares loss- and~     gain-framed messages that make the consequences of drinking and driving more salient to~     standard messages not to drink and drive.~   "
17666|NCT03335722|"~     This study aims to test whether the application of transcranial direct current stimulation~     (tDCS) concurrent with fluency training results in improvements in speech fluency in adults~     with developmental stuttering, measured up to three months after the intervention.~   "
17667|NCT03335709|"~     The purpose of the study is to evaluate a) the feasibility and b) the potential outcomes of a~     first version of an occupational therapy intervention program aiming at enhancing the ability~     to perform activities of daily living (ADL) among persons living with chronic conditions.~      In the study a pre-post test design is applied.~   "
17668|NCT03335696|"~     Follow-up study within the Whitehall II study, selecting 800 participants for further~     neuropsychological, clinical and imaging (MRI) examinations to examine brain structure and~     function in relation to age-related diseases and the modifiable and non-modifiable factors~     affecting resilience against and vulnerability to adverse brain changes.~   "
17673|NCT03335631|"~     Prostate cancer affects 1 in 7 men. Half of these men are treated with androgen deprivation~     therapy (ADT). ADT slows disease progression and prolongs survival, but it also leads to~     worse quality of life (QOL), fatigue, loss of strength and fitness, osteoporosis, and~     diabetes.~      The investigators' recent research has shown that individually supervised exercise,~     supervised group exercise and home-based exercise are equally good at improving these side~     effects. Now the investigators are doing a larger trial with multiple centres to see whether~     supervised group or home-based exercise is clinically better and more economical.~      A major challenge in such trials is that a significant number of men refuse to be randomized~     because (a) the participant lives too far from a study centre and cannot come for supervised~     exercise; or (b) the participant has a strong preference as to which type of exercise program~     the participant wants to do. Experts have raised concerns that classic randomized trials are~     too restrictive, selective, and less practical; the study results are less applicable to the~     real world. Despite its obvious importance, it is not known whether men who refuse to be~     randomized to an exercise trial but are otherwise willing to participate would benefit~     similarly to men who are randomized. In this study, we will recruit men who are otherwise~     eligible for our randomized trial but refuse it for one of the reasons above. We will allow~     these men to choose either supervised group or home-based exercise, and then compare them to~     the men who are being randomized to the two treatments in 3 important ways. First, are~     participants similar in terms of personal characteristics, QOL, and fitness levels? Second,~     do participants respond similarly to exercise in terms of QOL and physical fitness benefits?~     Third, do participants actually exercise as much as the randomized men? This work will help~     the research team understand whether there is a need to change the way exercise trials are~     done in order to be more relevant and wide-reaching for Canadians with a variety of health~     conditions.~   "
17674|NCT03335618|"~     The purpose of this 12-week, exploratory pilot clinical trial is to continuously and remotely~     assess a triad of bothersome multiple sclerosis (MS) symptoms (BAM: bladder, ambulation,~     mood) and test the benefit of proactively treating these symptoms according to an~     evidence-based, multi-disciplinary, personalized protocol.~   "
17675|NCT03335605|"~     This is an observational, case-control study with a single blood draw among two cohorts,~     patients with antibody deficiency (e.g., CVID) and healthy controls. Samples will be analyzed~     by mass cytometry (CyTOF) to examine the major signaling pathways of all circulating innate~     and adaptive immune cell types, as well as whole exome sequencing. The goal is to improve our~     general understanding of the human immune response to infections and the diagnosis of CVID.~   "
17676|NCT03335592|"~     Due to the emergence of multidrug-resistant micro-organisms in patients with bone and joint~     infection (BJI), the prescription of off-labeled antibiotics seem to be more and more common~     as part of routine care. These new antibiotics are, however, more expensive, and there are no~     precise data in France regarding the volume and cost of such off-label prescriptions in~     hospital, in the post-acute care structures, and in the outpatient setting.~      The objective of this study is to estimate the cost of using these antibiotics over 2 years~     for patients in a reference center for the management of complex bone and joint infection~     (CRIOAc)~   "
17677|NCT03335579|"~     The relationship between anesthetic medication and postoperative major cardiac and cerebral~     complications will be studied using logistic regression model.~   "
17678|NCT03335566|"~     The purpose of this study is to compare the efficacy of Sonazoid™ and SonoVue® in~     participants with focal liver lesions (FLLs), by comparing pre-and post-contrast ultrasound~     examination findings with regard to various aspects of lesion diagnosis including diagnosis~     as benign versus malignant, specific lesion diagnosis, confidence in diagnosis, and quality~     of delineation of lesion-related blood vessels (from images obtained during vascular imaging)~     and detection of lesion presence and quality of delineation of the whole liver (from images~     obtained during whole liver imaging).~   "
17679|NCT03335553|"~     This is a study of experimental medication BMS-986235 in healthy subjects.~   "
17680|NCT03335540|"~     The purpose of this study is to evaluate the treatment of solid tumors with various~     immunotherapy combinations. The treatment will be determined based upon a broad biomarker~     assessment.~   "
17681|NCT03335527|"~     Sleep disturbances frequently occur in intensive care unit (ICU) patients undergoing~     mechanical ventilation. In a previous study, sedative dose dexmedetomidine (median 0.6~     microgram/kg/h) improved sleep quality in mechanically ventilated patients. However, for~     mechanically ventilated patients, light sedation is better than deep sedation for the~     outcomes, which is manifested as shortened length of ICU stay, shortened duration of~     mechanical ventilation, and decreased mortality. In a recent study of the investigators,~     non-sedative low-dose dexmedetomidine (0.1 microgram/kg/h) improved sleep quality in~     non-mechanically ventilated elderly patients admitted to the ICU after surgery. The~     investigators hypothesize that, in mechanically ventilated patients who are admitted to the~     ICU after surgery, low-dose dexmedetomidine may also improve sleep quality.~   "
17682|NCT03335514|"~     The expression of GALNT4 in blood with acute coronary syndrome~   "
17683|NCT03335501|"~     Closed-loop strategy is composed of three components: glucose sensor to read glucose levels,~     insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required~     insulin dosages based on the sensor's readings.~      The objective of this pilot study is to inform both the decision whether to conduct a~     confirmatory study and the design of the larger confirmatory trial. In addition, we want to~     estimate postprandial glucose levels parameters and confidence interval in an 11-hour~     in-patient study with standardized conditions in adults with type 1 diabetes, estimate the~     size and direction of the treatment effect.~      Faster insulin Aspart (FiAsp) will provide preliminary evidence of efficacy to regulate~     postprandial glucose levels compared to rapid-acting Aspart in adults with type 1 diabetes~     using insulin pump therapy.~   "
17684|NCT03335488|"~     This is a randomized, controlled, open-label parallel arm study to assess the safety,~     tolerability, pharmacokinetics and ammonia control, of RAVICTI® as compared to NaPBA in urea~     cycle disorder subjects not currently or previously chronically treated with phenylacetic~     acid (phenylacetate; PAA) prodrugs. The study design will include: 1) Baseline Period; 2)~     Initial Treatment Period; 3) a RAVICTI only Transition Period 4) a RAVICTI only Maintenance~     Period; and 5) a RAVICTI only Safety Extension Period. The study will run for approximately~     25 weeks.~   "
17700|NCT03335280|"~     This is a prospective, Phase 2, single center, open-label study in adult patients with~     presumed WHO grade 3 or 4 glioma who will be undergoing surgical resection as standard of~     care. In some cases, patients will have had biopsy. Study participants will undergo~     68Ga-citrate PET/MR prior to surgery.~   "
17745|NCT03334695|"~     The purpose of this study is to assess a trend for the prophylactic efficacy of a single dose~     of 1*10^11 virus particles (vp) of adenovirus serotype 26 respiratory syncytial virus~     pre-fusion F protein (Ad26.RSV.preF) administered intramuscularly to adults aged 18-50 years~     in the respiratory syncytial virus (RSV) challenge model in terms of reduction of nasal wash~     viral load compared to placebo.~   "
17685|NCT03335475|"~     This study will adapt a physical activity lifestyle intervention to adolescent congenital~     heart disease (CHD) survivors with the primary goal of increasing physical activity levels.~      The study will be split into 2 phases. In Phase 1, participants will be asked to complete~     questionnaires, wear an accelerometer around the waist for 7 days, and undergo an exercise~     stress test. The accelerometer and exercise stress test will be used to determine whether~     participants are eligible to be randomized for the intervention study. A parent will be asked~     to complete questionnaires at baseline as well. In Phase 2, participants will be randomized~     to one of two conditions: 1) receiving a physical activity tracker (a Fitbit) or 2) receiving~     a Fitbit AND engaging in videoconferencing sessions with a physical activity coach. During~     Phase 2, participants will also be asked to complete 2 assessments (weeks 9 and 22). The week~     9 assessment will consist of completing questionnaires and wearing an accelerometer for 7~     days. Week 22 will be similar to week 9 with the addition of a final exercise stress test.~     The same parent will be asked to complete questionnaires at the final assessment as well.~      Participants who are randomized to the videoconferencing condition will be asked to meet with~     a physical activity coach 8 times over the course of 20 weeks. Coaches will help participants~     to (1) change attitudes toward physical activity, (2) increase perception of others' approval~     of physical activity (e.g., family members, peers), and (3) increase participants' perceived~     control by troubleshooting barriers and increasing efficacy for physical activity. Coaches~     will use the Fitbit to facilitate self-monitoring and goal setting.~   "
17686|NCT03335462|"~     Lumbar paravertebral block (LPB) has been used for anesthesia in different settings such as~     in varicocelectomy and inguinal hernia repair in adults and pediatrics. Different studies~     considered LPB as an alternative to general and spinal anesthesia when contraindications~     exist, especially in elderly patients. However, the results obtained when using LPB are~     controversial in terms of number of injections performed and the success rates.~   "
17687|NCT03335449|"~     This Randomized controlled clinical study, entitled Effects on Respiratory mechanics of two~     different ventilation strategies during Robotic- Gynecological surgery, is an original~     paper. The study was performed in Rome, Italy, from September 2014 to September 2015.~      Nowadays several studies evaluated the effects of open lung strategy and the positive~     effect of Recruitment Maneuvers and Positive End Expiratory Pressure (PEEP) application~     during general anesthesia, especially during open abdominal surgery and in elderly patients.~      This is the first study aimed at evaluating two different ventilation strategies in healthy~     respiratory women undergoing Robotic surgery. In particular, the investigators evaluated the~     effects of protective ventilation strategy on respiratory mechanics, gas exchange and~     post-operative respiratory complications compared to standard ventilation.~   "
17688|NCT03335436|"~     The purpose of this study is to determine whether a perioperative course of gabapentin in~     parturients on buprenorphine maintenance would improve analgesia after elective cesarean~     delivery (CD).~   "
17689|NCT03335423|"~     The investigators aim to investigate the interindividual variation in metformin AUC in a~     large cohort of healthy volunteers after a single dose of metformin. Part 1 is driven by the~     hypothesis that metformin AUC and renal clearance exhibit significant interindividual~     variation. However this has never been documented in a large cohort of healthy volunteers.~      The investigators aim to investigate the potential interaction between codeine and metformin~     in the intestine. The hypothesis underlying part 3 is that the increased risk of early~     discontinuation of metformin during co-administration with codeine is primarily due to local~     inhibition of OCT1 via codeine at the intestinal level.~   "
17690|NCT03335410|"~     Around 6400 shoulder surgeries are performed yearly in Finland. The procedure is mainly~     day-case surgery and the patients go home in the afternoon. Shoulder surgery is one of the~     most common procedures performed in private surgical practices. Because of the complex nature~     of the joint, the recovery may be complicated by severe opstoperative pain, which is relieved~     with strong opioids. Recently this has been addressed in the literature, as prescribed~     opioids too often lead to substance abuse. Pain in the acute phase after surgery is one of~     the common risk factors for persistent postoperative pain, which is a major burden for both~     the individual patient and the society.~      In this prospective, observational cohort study we aim to describe current standards of~     practice in planning and taking care of anaeshtesia and prescribing opioids and adjuvants for~     postoperative pain relief at home.~   "
17691|NCT03335397|"~     The aim of this study is to investigate whether a mobile application is useful for improving~     knowledge about professional competencies in students enrolled in Health Sciences degrees.~   "
17692|NCT03335384|"~     A cross-sectional study to explore the relationship between clinically assessed pulmonary~     function test (PFT) measures and transdiaphragmatic (Pdi) measures in Duchenne muscular~     dystrophy (DMD) as well as to explore the relationship between sniff nasal inspiratory~     pressure (SNIP) and transdiaphragmatic (Pdi) measures in Duchenne muscular dystrophy.~   "
17693|NCT03335371|"~     The purpose of this study is to evaluate the safety and efficacy of TTP399 in Type 1~     diabetics. This study will be in 2 phases: phase 1 will evaluate the safety of different~     TTP399 dosage regimens over 1 week of daily dosing. Phase 2 will evaluate the safety and~     efficacy of a TTP399 dosing regimen over 12 weeks of daily dosing.~   "
17694|NCT03335358|"~     This study aims to pilot test an 8-week, self-administered dyadic (couples-based) positive~     psychology intervention for couples coping with stroke using a randomized, waitlist control~     design. Mood and well-being will be assessed pre- and post-intervention, and at 3-month~     follow-up. It is expected that both partners will demonstrate improvement in mood and~     well-being.~   "
17701|NCT03335267|"~     This is an open label study to assess the suitability of CPX-351 as first intensive therapy~     in elderly (age ≥60 years) patients with AML. Patients may have received prior AML treatment~     with non-intensive regimens, e.g. hypomethylating agents, low dose Ara C or lenolidomide, but~     may not have received intensive AML treatment with anthracyclines and/or cytarabine prior to~     enrollment on this trial. The outcome of elderly patients following intensive treatment with~     CPX-351 will be measured by clinical endpoints for efficacy and safety and by~     biological/functional response.~   "
17777|NCT03334279|"~     The aim of this study is to detect P53 expression in clinically normal oral mucosa of~     cigarette smokers, simultaneous cigarette and cannabis smokers and non-smokers as a surrogate~     marker for field cancerization.~   "
17778|NCT03334266|"~     This study aims to assess the impact of a home-visiting program, called Family Spirit~     Nurture (FSN), on reducing early childhood obesity in American Indian (AI) children. The FSN~     intervention targets parent feeding practices, young children's diet and physical activity~     (PA) and early childhood (0-2 years of age) weight status, all associated with risk for early~     childhood obesity and, consequently, risk for obesity over the life course. The investigators~     will also explore whether maternal psychosocial factors (stress, depression and substance~     use), household food/water security and/or constrained physical activity environments~     moderate FSN intervention impacts on: mother's feeding behaviors for infants and toddlers;~     and, children's diets, PA patterns, and weight status. Finally, the investigators will~     examine how maternal/infant characteristics, diet and behaviors impact the underlying~     biologic mechanisms of early childhood obesity and whether social and behavioral~     interventions can impact infant metabolic health. The investigators evaluation will employ a~     randomized controlled design, in which both the intervention and comparison condition receive~     assisted transportation to prenatal and well-baby visits (called Optimized Standard Care),~     and the comparison condition also receives potentially beneficial injury prevention education~     at 8 assessment visits.~      Primary Aims:~      Efficacy of Family Spirit Nurture (FSN) + Optimized Standard Care (OSC) versus Injury~     Prevention Education (IPE) + OSC will be assessed for each of the following from birth to 24~     months postpartum:~      Aim 1. Mothers' implementation of recommended feeding behaviors. Hypothesis 1. FSN + OSC~     mothers will be more likely to meet breastfeeding and complementary feeding recommendations~     and engage in responsive parenting/feeding behaviors compared to IPE + OSC mothers.~      Aim 2. Children's consumption of healthy diet and physical activity engagement. Hypothesis 2.~     FSN + OSC children will consume more fruits and vegetables and fewer calories from sugar~     sweetened beverages (SSB), snacks and desserts, and they will have higher physical activity~     and reduced screen time/other sedentary activities compared to IPE + OSC children.~      Aim 3. Children's weight status. Hypothesis 3. Mean BMI z-scores for FSN + OSC children will~     be closer to zero (the mean age- and sex- specific BMI z-score for the World Health~     Organization standard reference population) compared to IPE + OSC children.~      Secondary Aims:~      Secondary Aim 1. To explore whether maternal psychosocial factors (stress, depression and~     substance use), and household food/beverage security and/or constrained physical activity~     environments moderate FSN intervention impacts on: infant and young children's feeding~     behaviors; and, infant/young children's diets, PA patterns, and weight status.~      Secondary Aim 2. To explore how maternal/infant characteristics, diet and behaviors impact~     the underlying biologic mechanisms of early childhood obesity, and whether social and~     behavioral interventions can impact infant metabolic health.~      Aim 2a. At delivery, examine how measures of infant metabolic health (fasting glucose,~     insulin, leptin, adiponectin, lipids, and c-reactive protein) are a) correlated with maternal~     biologic measures of metabolic health (fasting glucose, insulin, leptin, adiponectin, lipids,~     and c-reactive protein) and b) are impacted by sociodemographic, biological and psychosocial~     characteristics of mothers at baseline (e.g. age, parity, water/food security, BMI,~     gestational weight gain, gestational diabetes, depression, perceived stress). Hypothesis:~     Infant biologic measures of metabolic health will be highly correlated with maternal levels~     of metabolic health at birth and will vary by maternal baseline characteristics.~      Aim 2b. Between delivery and 12 months postpartum, examine how biologic measures of infant~     metabolic health change in relation to a) maternal biologic measures of metabolic health, b)~     sociodemographic, biological and psychosocial characteristics of mothers at baseline, and c)~     maternal/infant behaviors (e.g. responsive feeding practices, infant diet, introduction of~     sugar-sweetened beverages, early physical activity, etc.). Hypothesis: Biologic measures of~     infant metabolic health over the first 12 months of life will begin to diverge from maternal~     levels; and, infant metabolic health between delivery and 12 months postpartum will vary by~     maternal baseline characteristics and maternal/infant behaviors across study groups.~      Aim 2c. Infant metabolic health. Hypothesis: FSN + OSC infants will have better metabolic~     health (defined by fasting glucose, insulin, leptin, adiponectin, lipid and c-reactive~     protein levels) at 12 months postpartum compared with IPE + OSC infants.~   "
17695|NCT03335345|"~     Approximately 50 to 60% of ICU patients are subjected to invasive mechanical~     ventilation-through a tracheal tube. Extubation consists of a key moment for the patient on~     the road to recovery (1). The extubation failure, is a major disease event. The incidence of~     extubation failure vary between studies between 10% and 20% of ventilated patients over 48~     hours, it is therefore a significant risk including at the individual level. Ultimately, it~     is observed higher mortality for patients with unsuccessful extubation and this independently~     of their overall severity (2,3). Among the complications associated with extubation failure~     observed the occurrence of nosocomial pneumonia. Large-scale epidemiological data, covering~     nearly half of French ICUs found a risk of nosocomial pneumonia multiplied by a factor of 3~     in case of extubation failure. Observing this strong association between nosocomial pneumonia~     and extubation failure does not presage a causal link. In all cases the onset of pneumonia~     probably involved in the morbidity and mortality of patients undergoing a failed~     extubation(4).~      Prevention of inhalation may limit congestion and bronchial and lung infection, and thereby~     reduce the risk of extubation failure. Indeed, the primary pathophysiologic mechanism~     responsible for nosocomial bronchopulmonary infection is inhalation of oropharyngeal and~     digestive secretions (5).~      This risk of inhalation during intubation motivates the implementation of fasting prior to~     general anesthesia for elective surgery patients. Indeed, it is recommended to respect a~     6-hour fast for solids and 2 hours for liquid (water, fruit juices without pulp, tea or~     coffee without milk) in this situation (9).~      Although the situations are very different from the context of programmed anesthesia and~     extubation followed by a possible emergency reintubation on failure of extubation in the~     context of resuscitation, fasting appears as a potential means of limit the inhalation during~     the period of risk posed extubation and reintubation eventual resuscitation. Nevertheless, it~     is doubtful of the effectiveness of the single fasting to ensure gastric emptiness during the~     period of extubation. Indeed, a very large proportion of patients presents the delayed~     gastric emptying causing prolonged gastric fluid stasis. (10).~      Fasting and aspiration of gastric contents through a stomach tube has not, to our knowledge,~     never been rigorously evaluated in the ICU extubation.~      Moreover, the setting of fasting patients is likely to induce significant side effects first~     and foremost, a charge extra care for paramedics. The other major effect is the calorie~     deficit induced potential source of infectious complications and a delay in extubation.~   "
17696|NCT03335332|"~     Although current clinical guidelines stipulate that patients with hypertrophic cardiomyopathy~     should not partake in high intensity exercise (HIE) or competitive sport due to safety~     concerns, there is no clear evidence to support this notion. In fact, two exercise training~     interventions in this population indicates that regular moderate to vigorous intensity~     exercise is efficacious for improving exercise capacity and cardiorespiratory fitness, and~     does not increase arrhythmia burden or adverse events. Moreover, moderate intensity exercise~     and HIE training significantly increases cardiorespiratory fitness in patients with cardiac~     disease. Such improvements are associated with substantial reductions in cardiovascular~     mortality and might outweigh the risk of adverse events in patients with hypertrophic~     cardiomyopathy (HCM). Having a genetic cardiomyopathy does not grant immunity against~     lifestyle related cardiometabolic diseases and inactivity is rife in HCM patients likely due~     to misinformation/education. It is therefore paramount to further explore the benefits of~     regular moderate intensity exercise and HIE in patients with HCM for proper therapeutic~     management of the condition.~   "
17697|NCT03335319|"~     Benefits from cardiac rehabilitation (CR) programs are evidence based and widely recognized.~     Less than 50% of people who participate in hospital-based CR programs maintain an exercise~     regimen for as long as six months after completion. Despite the benefits associated with~     regular exercise training (ET), adherence with supervised exercise-based CR remains low.~      Current exercise guidelines for CR focus on moderate intensity steady state exercises, with~     walking and cycling being the most recommended types of ET. The repetitive nature of this~     type of activity can become monotonous for the patient, affecting exercise adherence,~     compliance and training outcomes. Exercise periodization is a method typically used in sports~     training, but the impact of periodized exercise to yield optimal beneficial effects in~     cardiac patients is still unclear.~      In healthy or trained populations, periodization aims to optimize ET adaptations as compared~     with non periodized training, to prevent overtraining and to avoid plateauing of training~     adaptations. Periodized methods are considered to be superior to non periodized methods in~     trained populations and appears to be superior in inactive adults. In most of the CR programs~     there are no periodization or exercise progression during medium to long term interventions.~     Further randomized controlled trials (RCT) are necessary to evaluate long-term periodization~     outcomes.~      The purpose of this research project is twofold:~        1. To conduct a 12-month randomized control trial to evaluate the effects of a periodized~          ET regime versus a non periodized ET regime (guidelines) on VO2 peak, maximal strength,~          body composition, functionality and quality of life in cardiovascular disease patients.~        2. to differentiate the effects of a 12-month periodized ET regime versus a non periodized~          ET regime on the different components of the oxygen kinetics response and oxidative~          adaptations in cardiovascular disease patients.~      These patients will be randomized in 2 ET groups: 1) periodization; 2) non periodization.~     This experimental design will occur during 48 weeks 3 times per week with 4 assessment time~     points: M0) before starting the ET program (baseline); M1) 3 months after starting the ET;~     M2) 6 months after starting the ET program and M3) 12 months at the end of the~     community-based ET program.~   "
17698|NCT03335306|"~     Background: Different people are classified into different physiological constitution types~     in the Traditional Chinese Medicine (TCM) theory. Two instruments, the Body Constitution~     Questionnaire (BCQ) and the Constitution in Chinese Medicine Questionnaire (CCMQ), have been~     developed in Taiwan and Mainland China respectively to measure constitution. They were~     adapted and pilot tested in primary care Chinese patients in Hong Kong, which showed~     acceptable validity and reliability. These instruments have potential applications for~     epidemiological studies on body constitution.~      Aim and objectives: The aim of this study is to establish the prevalence and epidemiology of~     body constitution classified by the Traditional Chinese Medicine Theory in the Chinese~     population in Hong Kong. It would also determine whether the prevalence of constitution types~     change with seasons and whether it is associated with socio-demographic factors, place of~     origin or residence, life style, or quality of life.~      Design and subjects: Two cross-sectional telephone surveys of the Hong Kong (HK) general~     Chinese population, one in Summer and one in Winter, will be carried out. Sample size for~     each survey is 3200 subjects.~      Methods: Residential-telephone-owning households will be contacted through random dialing by~     the Social Science and Research Centre of the University of Hong Kong using the~     Computer-Assisted Telephone Interviewing (CATI) system that covers 95% households in Hong~     Kong. A member, aged 18 or above, of the contacted household who last had his/her birthday~     will be invited to the study to answer either the BCQ or the CCMQ and a structured~     questionnaire on socio-demographics, place of origin, place of residence, health service~     utilization, life style and quality of life.~   "
17699|NCT03335293|"~     This is a prospective, randomized, double blind study of 75 patients (n=25 for each group) in~     which epinephrine (100mcg or 200mcg) or normal saline vehicle is added to intrathecal~     hyperbaric bupivacaine (0.75% bupivacaine hydrochloride in 8.25% dextrose), fentanyl, and~     morphine to prolong the duration of the spinal anesthetic in scheduled cesarean deliveries.~     The primary outcome of duration will be the time to T10 level sensory regression as well as~     motor level regression that will be graded via the modified Bromage scale.~      Repeat cesarean sections, in particular, are associated with increased operative time and~     thus often performed with a spinal-epidural (CSE) technique. The epidural component is,~     however, untested and may not provide adequate anesthesia, thus the higher risk of conversion~     to a general anesthesia. Epinephrine is routinely used to prolong spinal anesthesia. If~     effective for the duration of a repeat cesarean section it would obviate the additional time~     and risks of performing the epidural and still avoid sufficient duration to avoid conversion~     to a general anesthetic.~   "
17705|NCT03335215|"~     The individual and societal cost of alcohol use disorders (TUAL), present in 10% of the~     population in France, is considerable. Despite psychotherapeutic and drug addiction~     treatment, the relapse rate remains very high, partly because of their very frequent~     cognitive disorders. In fact, more than 75% of TUAL patients present to varying degrees~     neuropsychological alterations that are only rarely detected and never treated. However,~     these cognitive disorders limit the benefit of psychotherapeutic care, reduce compliance with~     pharmacological treatments and hinder the patient's ability to change his behavior with~     respect to alcohol. An innovative way to promote the maintenance of the therapeutic contract,~     and therefore to reduce alcohol consumption in these patients, would be to improve their~     cognitive functioning. The objective of this study is to measure the efficacy of a non-drug~     treatment, based on a specific and personalized cognitive remediation program, compared to a~     standard treatment in Day Hospitalization, in order to reduce the rate of relapse very high~     in TUAL. It is a randomized, single-blind study with two parallel groups of patients with~     post-weaning neuropsychological disorders: REMED (cognitive remediation) and CONTROL (usual~     care).~   "
17706|NCT03335202|"~     Respiratory und intestinal microbiome will bei analyzed during a period of 6 months. In a~     retrospective analysis it will be looked for correlations between microbiome and cf therapy~     (e.g. inhaled and systemic antibiotics, cftr modifiers, proton pump Inhibitors, enzymes,~     nutritional habits), clinical status and self reported outcome.~   "
17707|NCT03335189|"~     The Advanced Symptom Monitoring and Management System - Canada (ASyMS-Can) is a remote~     phone-based symptom management system that prompts patient self-care and clinician telephone~     triage and intervention based on alerts for managing cancer treatment side effects such as~     nausea and vomiting, fatigue, etc. ASyMS-Can is an android phone-based application that is~     given to patients to self-report their symptoms using a patient reported outcome symptom~     questionnaire and level of severity daily, on a secure mobile android phone, from home or~     outside of clinics. Based on back-end computations, patients receive automated self-care~     notifications on their mobile phones with advice on self-care for mild to moderate severe~     symptoms. The system also in the case of severe symptoms will alert the designated clinic~     nurse to prompt electronic telephone triage and intervention (yellow alert response in 8~     hours or within 30 minutes for severe symptoms-red alert).~   "
17708|NCT03335176|"~     The aim of this study is to assess the feasibility and the effects of a 6-week~     telerehabilitation on the three domains of the International Classification of Functioning,~     Disability and Health in HIV-infected patients under highly active antiretroviral therapy~     (HAART).~      HIV-infected patients were randomized either into an Endurance and Resistance Training~     Exercise (ERTE) group or a control (CON) group. Telerehabilitation was realized in a public~     fitness center, with online guidance and weekly telephone advice, 3 times per week for 6~     weeks. Feasibility was determined by recruitment rate, retention rate and adverse events.~     Secondary outcomes were impact on body composition, inflammation and coagulation (C-reactive~     protein, D-dimer), physical fitness and quality of life (WHOQOL-HIV).~   "
17709|NCT03335163|"~     A prospective, non-inferiority study to evaluate the pharmacokinetic effect of topiramate on~     serum Etonogestrel (ENG) levels in contraceptive implant users.~   "
17710|NCT03335150|"~     To investigate the effectiveness of a novel compensatory cognitive rehabilitation program for~     individuals with Parkinson's disease (PD) and mild cognitive impairment (MCI).~   "
17711|NCT03335137|"~     At antibiotic stewardship of the University Hospital of Schleswig-Holsten it was noticed that~     there are much less studies measuring drug levels in severe burned patients than are~     required. Especially, severe burned patient developing a capillary leak might show lower drug~     levels than patients without a capillary leak. To compare drug levels of beta-lactam~     antibiotics, it is the aim of this study to measure pharmacokinetics of~     Piperacillin/Tazobactam in ICU patients with and without severe burns.~   "
17712|NCT03335124|"~     The global burden of sepsis is substantial with an estimated 15 to 19 million cases per year;~     the vast majority of these cases occur in low income countries. New therapeutic approaches to~     sepsis are desperately required; considering the global burden of sepsis these interventions~     should be effective, cheap, safe and readily available. The aim is to study the synergistic~     effect of vitamin C, hydrocortisone and thiamine on survival in patients with severe sepsis~     and septic shock.~   "
17713|NCT03335111|"~     Influence of bilateral arm ischemic postconditioning （BAIPC）on the injury and protective~     blood markers and the clinical prognosis and outcome in patients with acute ischemic stroke~   "
17714|NCT03335098|"~     This study is a phase 2, single-arm, open-label, multi-institutional trial to evaluate the~     efficacy of combination therapy of bortezomib, thalidomide, and dexamethasone in patients~     with newly diagnosed Waldenstrom's macroglobulinemia and lymphoplasmacytic lymphoma.~   "
17715|NCT03335085|"~     This study evaluates whether intranasal administration of a single dose of oxytocin improves~     the ability to recognize emotional states. In a cross-over design, half of the participants~     first received oxytocin, the other half first received placebo.~   "
17716|NCT03335072|"~     The investigators propose a cluster-randomized clinical trial to determine whether an~     intensive, targeted azithromycin distribution strategy is effective for elimination of~     trachoma at the kebele level compared to the World Health Organization (WHO) recommendation~     of annual azithromycin distribution.~   "
17717|NCT03335059|"~     This study will determine whether Synergo® RITE + MMC treatment is efficacious as second-line~     therapy for CIS NMIBC BCG-unresponsive patients with or without papillary NMIBC, through~     examination of the complete response rate (CRR) and disease-free duration for complete~     responders. The study will also explore progression-free survival time, bladder preservation~     rate, and overall survival time.~      The study will address an unmet need to identify a treatment effective in both ablating the~     disease and providing a prolonged disease-free period for patients. Ideally, the treatment~     will delay progression to invasive disease, thus preserving the bladder.~   "
17718|NCT03335046|"~     This study will establish a multi-disciplinary home visitation team consisting of a medical~     provider and school teacher or staff member, and will evaluate whether a series of visits~     from this team will help decrease school absenteeism among children with asthma.~   "
17719|NCT03335033|"~     The researchers are trying to determine if the characterization of vulnerable carotid~     artery plaques can be accomplished with ultrasound-based methods that look for vessels in the~     plaque and measure the plaque stiffness.~   "
17720|NCT03335020|"~     The researchers are trying to see whether contrast-enhanced ultrasonography, shear wave~     elastography, strain imaging, and 3-D volume ultrasonography improves arterial wall~     visualization and identifies arterial elastic properties among individuals with fibromuscular~     dysplasia (FMD), atherosclerosis, personal history of spontaneous coronary artery dissections~     (SCAD), or personal history of segmental arterial mediolysis (SAM) that may be different~     compared to those without the aforementioned conditions.~   "
17721|NCT03335007|"~     The aim of this prospective, randomized, double-blind, clinical trial is to evaluate the~     effect of a preoperative, single, oral dose of aceclofenac (100 mg) on postendodontic pain at~     6, 24 and 48 hours, postoperative pain at injection area at 6, 24 and 48 hours and analgesic~     intake after single-visit root canal treatment.~   "
17722|NCT03334994|"~     Aim of current study to evaluate connective tissue graft combined with immediate implant~     placement as an innovative option for less facial gingival tissue recession, less pocket~     depth and less clinical attachment loss versus immediate implant alone.~   "
17723|NCT03334981|"~     The aim of this study is to characterize the interest of concentrations in meconium of drugs~     used for treatment of pregnant opioid-dependent woman as a prognostic factor of time,~     severity and duration of neonatal abstinence syndrome (NAS). 43 women treated with~     buprenorphine, 49 with methadone, and their newborns, were included. NAS is assessed by~     Lipsitz scale. Buprenorphine, norbuprenorphine, methadone, EDDP and morphine are quantified~     in meconium (one collected immediately after birth, another for 24 to 48 h) by a liquid~     chromatography-tandem mass spectrometry (LC-MS/MS) method, developed and validated for this~     study.~   "
17724|NCT03334968|"~     Stroke is a major cerebrovascular disease that causes significant burdens for human health~     and life, including high morbidity, mortality, and disability. Prolidase enzyme activity was~     found in various organs, such as the heart, brain, thymus, kidney, lung, pancreas, and~     spleen, and in plasma, leukocytes, erythrocytes, and dermal fibroblasts. An increase in~     collagen turnover is known to be correlated with increased prolidase enzyme activity. The aim~     of this study was to investigate whether SPA levels in AIS patients can be used as a~     potential diagnostic and prognostic marker. SPA levels were prospectively evaluated in 37~     patients aged between 20 and 85 years who were admitted within 24 hours of the onset of AIS.~     The control group included 37 healthy volunteers of similar age without any disease.~   "
17725|NCT03334955|"~     Serum level of total testosterone was measured in the early follicular phase (days 2-4 of~     spontaneous cycle in oligomenorrhic patients). To start the study in amenorrhic patients~     (after exclusion of pregnancy) they received progesterone (oral Norethisterone Acetate 10 mg~     daily for 5 days) to induce withdrawal bleeding and total testosterone was measured in days~     2-4 of this withdrawal bleeding.~      Color Doppler ultrasound scanning will be performed to assess the subendometrial blood flow.~     The subendometrial region was observed and analyzed in each woman using color and power~     Doppler flow ultrasonography. By means of color and power Doppler flow imaging, color signals~     was searched for in the subendometrial region and areas of maximum color intensity,~     representing the greatest Doppler frequency shifts, was visualized, then selected for pulsed~     Doppler examination. Pulsatility index (PI) and resistance index (RI) were calculated in each~     selected Doppler wave.~      Laparoscopic ovarian drilling was performed under general anesthesia with good muscle~     relaxation and endotracheal intubation using the three-punctures technique (one puncture 10mm~     at the umbilicus and the other two punctures 5mm at both iliac fossa) in the early follicular~     phase (after stoppage of menstrual or withdrawal bleeding).~      A specially designed monopolar electrocautery probe was used to penetrate the ovarian capsule~     at 4 points (regardless of the size of the ovary), with the aid of a short burst of monopolar~     diathermy. The probe (which has a distal stainless steel needle measuring 10 mm in length and~     2 mm in diameter) was applied to the surface of the ovary at a right angle to avoid slippage~     and to minimize surface damage. A monopolar coagulating current at a 40 W power setting was~     used. The needle was pushed through the ovarian capsule for about 4 mm depth into the ovarian~     tissue and electricity was activated for 4 seconds. The ovary was then cooled using 200 ml~     crystalloid solution before releasing the ligament.~      Follow up:~      Total testosterone and blood flow assessment (PI - RI) of the subendometrial region were~     performed again in the early follicular phase (days 2-4 of the menstrual cycle) of the first~     post-operative spontaneous menstruation (which occurred within 10 weeks after the operation).~      Also, patients were followed to detect ovulation. ovulating patients were followed for 6~     months to detect pregnancy.~   "
17726|NCT03334942|"~     The objective of this study is to evaluate the effectiveness of the Child and Family~     Traumatic Stress Intervention (CFTSI), provided soon after a violent traumatic event, in~     producing significant and sustained reduction in PTSS among assault injured youth.~   "
17727|NCT03334929|"~     This study aims to evaluate the effect of Virtual Reality (VR) as a distraction method to~     help those patients undergoing trigger points therapy to reduce anxiety and increase patient~     satisfaction. Half of the participants will wear VR gear, meanwhile the other half will be in~     control group, which will not wear VR headset, only the normal care.~   "
17728|NCT03334916|"~     This is a phase 4, randomized, double-blind, multicenter clinical trial to evaluate the~     efficacy and safety of YMC026 in respiratory disease patients with cough and sputum as the~     main symptoms~   "
17729|NCT03334903|"~     The purpose of this study is to determine the best strategy of administering gabapentin in~     connection with our current approach to perioperative pain management. We aim to evaluate two~     different adjunct gabapentin regimens given in the perioperative period, and to identify~     which manages patient pain more effectively and safely. In this evaluation, we will identify~     the quantity of patients' opioid consumption, the quality of their pain management, and the~     frequency and severity of any side effects they might experience.~      Patients who are undergoing total knee replacement (TKR) and choose to participate will be~     randomly assigned to a treatment group using computer-generated randomization. Patients in~     group 1 (the control group) will receive the standard of care as pertains to gabapentin. This~     consists of a single 600 mg dose of gabapentin administered to the patient approximately one~     to two hours before surgery, then a dose of 600 mg each morning during postoperative~     admission. Patients in Group 2 will receive 600 mg preoperatively, plus an additional~     postoperative gabapentin regimen: they will take 300 mg of gabapentin every 8 hours for 1~     week, then a single nightly dose of 300 mg for another month.~   "
17730|NCT03334890|"~     The surgical therapeutic effect of stage II-IV CRC patients will be assessed by the plasma~     mSEPT9 assay, and patients will be followed up by the same assay for recurrence monitoring.~   "
17807|NCT03333889|"~     P: Population: Patients requiring single unit implant restoration in esthetic zone I:~     Intervention: Polymer-infiltrated-ceramic-network abutment crown (VITA Enamic-VITA~     Zahnfabrik) C: Comparison: Lithium disilicate ceramic abutment crown (IPS e. max-Ivoclar~     Vivadent) O: Outcome: patient satisfaction , crestal bone loss and periodontal parameters T:~     Time: 12 months S :Randomized controlled trial research question:For patients receiving~     implants in esthetic zone, Does the use of polymer-infiltrated-ceramic-network hybrid~     abutment crown offer better patient satisfaction , less bone loss and better peri-implant~     clinical parameters when compared to lithium disilicate hybrid abutment crowns?~   "
17731|NCT03334877|"~     Two hundred and twenty women with singleton pregnancies and risk factors for spontaneous~     preterm birth were included in this study. Cervico vaginal fluid sampling was undertaken for~     qualitative assessment of β -human chorionic gonadotropin (β-hCG) and fetal~     fibronectin(fFN)at 24 weeks of gestation.~      For qualitative assay of both b-hCG and fFN, first vaginal specimens were collected by the~     following method:~      Specimen collection~      A sterile Cusco speculum was introduced into the vagina; the anterior lip of the cervix was~     grasped with sponge forceps and a cotton-tipped swab was placed into the external part of the~     endocervical canal (not reaching the internal os) and then into the posterior fornix (each~     for at least 1 min) to obtain an adequate sample of cervico vaginal secretions. Sampling was~     performed before doing any cervical manipulation (digital or ultrasound examination) and~     before introducing any vaginal material (lubricants or medications). The Hologic Specimen~     Collection Kit is the only acceptable specimen collection system which can be used to collect~     specimens for this assay. The polyester tipped swab provided in the Specimen Collection Kit~     should be inserted into the vagina and lightly rotated across the posterior fornix for~     approximately 10 seconds to absorb the cervico vaginal secretions. Once the specimen is~     obtained, carefully remove the swab from the vagina and place it into the tube of buffer~     provided with the Specimen Collection Kit. Two Specimen Collection Device per patient were~     obtained; one for each assay. Label the Specimen Transport Tubes with the patient's name and~     any other identifying information required.~      All women were then followed up till delivery. Women were categorized into two arms: women~     who delivered preterm (before 37 completed weeks of gestation) and women who delivered at~     term (after 37 completed weeks of gestation).~   "
17732|NCT03334864|"~     Investigators propose to establish and maintain a cohort of patients with advanced non-small~     cell lung cancer, and to assess the treatment pattern, host genetic, and clinical factors~     which influence the prognosis and survival, as well as the interaction among these factors on~     disease diagnosis and treatment, short and long-term outcomes.~      Study type: Observational (Patient Registry)~      Study design: Observational Model: Cohort~      Time Perspective: Prospective and retrospective~   "
17733|NCT03334851|"~     This is a Phase 1 single and multiple dose escalation study to evaluate the safety,~     tolerability, pharmacokinetics, and pharmacodynamics of PF-06835375 in subjects with~     seropositive SLE or RA. The design is double-blind, sponsor open and placebo controlled. This~     study will include two parts: Part A and Part B. Part A will consist of single ascending dose~     cohorts, Part B of multiple ascending dose cohorts. This study will enroll up to a total of~     approximately 112 subjects at approximately 10 sites.~   "
17734|NCT03334838|"~     This study will evaluate the effect of food on the absorption of the drug as well as safety~     and tolerability in adults suffering from chronic Chagas' disease In addition~     pharmacokinetics of the drug following 120 and 240 mg single doses will be assessed~   "
17735|NCT03334825|"~     Randomized controlled trial of housing placement assistance for homeless persons with HIV~   "
17736|NCT03334812|"~     The purpose of this (Proof of Concept) PoC study is to assess safety, tolerability and~     preliminary efficacy of intra articular (i.a.) LNA043 in regenerating the articular cartilage~     of the knee at the donor sites of the autologous chondrocyte implantation (ACI) procedure,~     with a hyaline tissue, significantly more often than with placebo.~   "
17737|NCT03334799|"~     Women with pelvic girdle pain PGP) often get relief from using a sacroiliac belt. The study~     will explore if there are differences and in the changes of lower body movement in stability~     with the belt on and with the belt off. Women with PGP will be matched with women without to~     explore if there is a difference between these two groups. This will be looked at in standing~     and in walking.~   "
17738|NCT03334786|"~     The FLX-787-107 study will determine how well FLX-787-ODT works to reduce fasciculations in~     patients with Amyotrophic Lateral Sclerosis (ALS). The study will measure how often~     fasciculations occur, if tongue and muscle strength, speech, and swallowing are affected, and~     monitor any side effects that might develop while taking the investigational product.~     Participants will be assessed before and after taking a single dose of FLX-787-ODT.~     Approximately 15 people will take part in this study at one center in the United States.~     Participants will be in the study for a single clinic visit and receive a telephone call 7~     days later to monitor for side effects.~   "
17739|NCT03334773|"~     Aim: To implement a nutrition education programme (intervention) for adults with type 2~     diabetes mellitus (T2DM) adapted from a primary health care setting to a tertiary hospital~     setting in South Africa and to evaluate the programme's effectiveness on dietary behaviours,~     clinical status and selected potential behaviour mediators.~      Participants and setting: T2DM adults (40-70 years) and at least one year of living with~     diabetes and poorly controlled diabetes (HbA1c ≥ 8%). The study setting is the outpatient~     clinic of a tertiary teaching hospital in Tshwane District (Pretoria), South Africa.~      Intervention: The intervention will employ a randomised control design with two parallel~     groups (intervention & control). A total sample of 140 T2DM patients (70 per group) will be~     needed to detect a 0.5 % change in HbA1c (SD of 1.0 and a power of 80%) at six month and~     allowing a 10% attrition rate. The intervention is one-year long with the following~     components: 7-monthly group education sessions; 2 bi-monthly group follow-up sessions at the~     hospital till one year; participants' workbook for goal setting activities and education~     materials (pamphlet and wall/fridge poster) for the intervention group. The control group~     will receive the same education materials with no other education encounters. Both groups~     will continue with usual care at the diabetes outpatient clinic of the hospital. The~     education will be offered face to face, will utilize teaching aids including coloured posters~     and will incorporate interactive group activities and demonstrations. The main facilitator is~     a qualified dietitian.~      Outcomes: Outcomes will be assessed at 6-and 12 months for both groups with the six month~     being the primary outcome. Outcomes will include clinical [HbA1c (primary outcome), BMI,~     blood pressure and full lipid profile); dietary behaviours (energy intake, starchy food~     servings, vegetable and fruits intake, macronutrient intake and their distribution to energy,~     fibre, meal pattern) and selected potential mediators of behavior (diabetes knowledge and~     diabetes management self- efficacy).~      It is hypothesized that the intervention will lower the HbA1c levels by at least 0.5% at six~     months and the levels will be significantly lower in the intervention group compared with the~     control group, and the significantly lower levels will be sustained at 12 months in the~     intervention group.~   "
17740|NCT03334760|"~     This study examines the associations between different types of infant feeding and BMI and~     overweight in childhood. The study is based on the Danish National Birth Cohort, established~     in 1996.~   "
17741|NCT03334747|"~     KAE609 will be evaluated primarily for hepatic safety of single and multiple doses in~     sequential cohorts with increasing doses.~      This study aims to determine the maximum safe dose of the investigational drug KAE609 in~     malaria patients.~   "
17742|NCT03334734|"~     Multicenter, open, randomized study with active control (isoniazid) to evaluate the early~     antibacterial activity, safety and pharmacokinetics of the drug PBTZ169 (capsules 80 mg) when~     used in patients with first-diagnosed tuberculosis of the respiratory system with bacterial~     excretion and saved bacterial susceptibility to isoniazid and rifampicin~   "
17743|NCT03334721|"~     The proposed 2-week, double-blind, crossover, proof of concept study aims to measure and~     manipulate core neurochemical (i.e., dysregulated brain GABA/glutamate homeostasis) and~     neurobehavioral (i.e., elevated impulsivity) dysfunctions characteristic of individuals with~     cannabis use disorder (CUD) and Bipolar Disorder (BD), using a medication that has been shown~     to increase cortical GABA (i.e., gabapentin) levels in past research, and to evaluate~     medication-related changes in response inhibition (go no-go) and cannabis cue reactivity~     functional Magnetic Resonance Imaging tasks, as well as cannabis use, mood symptoms~     (including anxiety and sleep), and impulsivity in individuals with CUD+BD.~   "
17746|NCT03334682|"~     Acne vulgaris of adult woman has increased over the past 10 years; it affects currently 20%~     to 30% of adult women.~      The physiopathology of adult woman acne is distinguished from the teenager one by essentially~     2 factors:~        -  hormonal factor with a peripheral hyperandrogenism coupled with an hypersensibility of~          cutaneous androgens receptors of these women. But this point is still at the stage of~          hypothesis.~        -  inflammatory factor linked with Propionibacterium Aces ; indeed these women received~          most of the time many cures of local and systematic antibiotics at the origin of~          resistant Propionibacterium Aces strains which lead to a chronical activation of~          cutaneous innate immunity.~      On a therapeutic plan, four types of systemic treatment, approved in this indication are:~        -  Tetracyclines which are problematic for the bacterial resistance and consequently~          constant relapse when they are stopped.~        -  Zinc salts which target only the inflammatory lesions and were shown less effective than~          cycline~        -  Antiandrogens, with acetate of cyproterone associated with risks of phlebitis and~          pulmonary embolism, and increase risk of triglycerides, cholesterol and hepatic balance.~        -  The last alternative is represented by isotretinoin but the use in women of childbearing~          potential is binding because of the teratogen risks and the hyperandrogenism represents~          an identified risk of relapse.~      In this context, the spironolactone could represent an interesting alternative. It blocks the~     5-alpha-reductase receptors at sebaceous gland and inhibits Luteinizing hormone (LH)~     production at the pituitary level. It is not submitted to isotretinoin constraints, does not~     lead to bacterial resistance and targets the peripheral hyperandrogenism.~      Currently, very few studies have been performed and on a weak number of patients but they~     showed that at low doses (lower than 200mg/day), spironolactone can be effective against~     acne.~      In that context, it seemed clearly interesting to perform the first double-blind randomized~     study spironolactone vs cyclines which remains the moderate acne reference treatment and to~     demonstrate the superiority of spironolactone's efficacy in order to establish it as~     alternative way to cycline.~   "
17747|NCT03334669|"~     The Communities for Healthy Living (CHL) program is a family-focused intervention to promote~     healthy lifestyle behaviors including diet and physical activity among children (age 3-to~     5-years) and their families, enrolled in Head Start.~   "
17748|NCT03334656|"~     Cell-based engineered skin substitutes are promising to treat difficult-to-heal acute and~     chronic wounds such as large/deep burns, ulcers resistant to conventional therapies or~     surgical wounds. Cultured autologous epidermal cell-based therapy is used for more than two~     decades as permanent wound coverage for large burns. Although this technique has been shown~     to improve outcomes in patients with large burn injuries, its clinical use is limited by the~     creation of a second wound at the donor site, the three-week delay needed to obtain~     sufficient amounts of cells, and the absence of a dermal component resulting in low graft~     take and wound contraction.~      Concurrently, allogeneic cell-based engineered skin substitutes have been proposed. Where~     they offer off-the-shelf temporary wound coverage acting as biologically active dressings~     releasing growth factors, cytokines and extra cellular matrix components essential for proper~     wound healing, they are susceptible of immune rejection that is their major weakness Fetal~     skin, before the third trimester of gestational age, heals rapidly without scar formation~     conversely to adult skin. Minimal inflammation, specific cytokine and growth factor profiles,~     and faster and organized deposit and turnover of Extra Cellular Matrix (ECM) components~     during fetal wound healing have been proposed to explain the absence of scar formation.~     Because of their low immunogenicity, and their unique regeneration properties, fetal skin~     cells represent an attractive alternative to the commonly used autologous and allogenic~     cutaneous grafts.~      The investigators developed a new healing dressing constituted by a collagen sponge seeded~     with a specific ratio of active fetal fibroblasts and keratinocytes producing a variety of~     wound healing growth factors and cytokines which increase the speed of wound healing, induce~     an immunotolerant state, with a low inflammatory reaction.~      This prospective randomized controlled study aims to compare wound healing of CICAFAST versus~     conventional treatment (JELONET®) in the treatment of split-thickness skin graft donor site~     at D8. The patient will be his own control.~   "
17749|NCT03334643|"~     This study determines the acute effect of a dietary fiber mix on blood glucose levels.~     Participants will consume the fiber mix as a drink and we will monitor changes in blood~     glucose levels. All participants will consume white bread as the control food.~   "
17750|NCT03334630|"~     The purpose of the DIAMOND-AF study is to establish the safety and effectiveness of the~     DiamondTemp System for the treatment of drug refractory, recurrent, symptomatic paroxysmal~     atrial fibrillation in patients.~   "
17751|NCT03334617|"~     This is an open-label, multi-centre, umbrella Phase II study in patients with metastatic~     NSCLC who have progressed on an anti-PD-1/PD-L1 containing therapy. This study is modular in~     design, allowing initial assessment of the efficacy, safety, and tolerability of multiple~     treatment arms.~   "
17752|NCT03334604|"~     In this trial, the investigators aim to assess the effectiveness of a multispecies probiotic~     consisting of 2 strains of Bifidobacterium (B. bifidum W23, B. lactis W51) and 6 strains of~     Lactobacillus (L. acidophilus W37, L. acidophilus W55, L. paracasei W20, L. plantarum W62, L.~     rhamnosus W71, and L. salivarius W24) in reducing the risk of antibiotic-associated diarrhoea~     in a group of children undergoing antibiotic therapy for common infections.~   "
17753|NCT03334591|"~     The investigators hope that after this research, two different treatment methods' curative~     effects for advanced gastric cancer can be assessed. One is continuous use of apatinib, the~     other is 5 days' continuous use and 2 days' off of apatinib.~   "
17754|NCT03334578|"~     This study will investigate the use of a drug called Gastrografin to aid in bowel mobility~     for paediatric patients who have undergone gastroschisis surgery. Gastroschisis is an~     abdominal wall birth defect where the bowel protrudes through a small opening beside the~     umbilicus. In these patients, the bowel is often less mobile due to its exposure outside of~     the body during fetal development. It is common for the bowel to be swollen and matted, which~     decreases motility and makes it increasingly difficult for the baby to have normal bowel~     function. Administering Gastrografin facilitates the entry of water into the intestines and~     bowel, which is thought to aid in bowel function and motility. This study will compare~     gastroschisis patients who received Gastrografin to gastroschisis patients collected as part~     of an ongoing observational study at our centre who did not receive Gastrografin.~   "
17755|NCT03334565|"~     The objective of this study is to investigate the effectiveness of air filtration at reducing~     personal-level exposures to fine particulate matter (PM2.5) and mitigating related~     cardiovascular (CV) health effects among older adults in a residential facility in a~     representative US urban location.~      We enrolled 40 nonsmoking older adults into a randomized double-blind crossover intervention~     study with daily CV health outcomes and PM2.5 exposure measurements. The study was conducted~     in a low-income senior living apartment building in downtown Detroit, Michigan.~      Participants were exposed to three 3-day scenarios separated by one-week washout periods:~     unfiltered ambient air (control), low-efficiency (LE) HEPA-type, and high-efficiency (HE)~     true-HEPA filtered air using air filtration systems in the bedroom and main living space of~     each residence.~      The primary outcome was brachial blood pressure (BP). Secondary outcomes included noninvasive~     aortic hemodynamics and pulse wave velocity and heart rate variability. PM2.5 exposures were~     measured in the participants' residences as well as by personal-level monitoring.~   "
17808|NCT03333863|"~     Positive results of bacterial culture are analyzed comprehensively in Shengjing Hospital of~     China Medical University in recent 3 years（between 2015- 2017）~   "
17756|NCT03334552|"~     In natural HIV disease, a small fraction (1-2%) of infected individuals develops~     exceptionally high titres of HIV-1 neutralizing serum activity. Antibodies isolated from~     these individuals have been shown to be highly active against a broad range of different HIV~     strains and are therefore called broadly neutralizing antibodies (bNAbs). These antibodies~     are in fact able to prevent (S)HIV infection in animal models and therefore of great interest~     for the development of an HIV vaccine. Information of neutralizing antibodies in patients~     from Africa is still scarce and would be of great value in the development of adapted HIV~     vaccine strategies in these regions. This study aims to investigate African HIV-infected~     individuals, who have developed neutralizing antibodies using highly specialized laboratory~     methodologies.~   "
17757|NCT03334539|"~     The objective of this study is to compare the safety and efficacy of 0.10% and 0.25% HL036~     Ophthalmic Solutions to placebo for the treatment of the signs and symptoms of dry eye.~   "
17758|NCT03334526|"~     Physical activity is considered a therapeutic strategy in its own right in a vast majority of~     disabling chronic disorders. It leads to an increase in physical and probably cognitive~     capacity, thanks to its effects on both metabolism (muscle hypertrophy, improvement in~     oxidative metabolism) and the nervous system (neuroplasticity). Nonetheless, even though~     there is a consensus on the positive effects of physical exercise (PE) on cerebral~     plasticity, the physiological mechanisms by which PE affects neuroplasticity, in particular~     depending on the mode of muscle contraction, are still hypothetical. Moreover, several recent~     studies have shown that mental learning (ML) by motor imagery improves motor performance,~     thus making it of interest in a context of rehabilitation, in particular in situations where~     PE is transient of definitively impossible. Yet, the mechanisms and brain structures involved~     in motor learning by ML have not been established so far. Finally, on the basis of clinical~     observations concerning the key role of sensory input in motor function, the hypothesis that~     increased demand on this input by electrical stimulation (ES) as a means to improve motor~     function has been proposed. However, the mechanisms by which this type of stimulation could~     induce neuroplasticity is still to be elucidated.~   "
17759|NCT03334513|"~     The investigators compared long-term refractive and biometric outcomes in children with~     retinopathy of prematurity who received two different anti-vascular endothelial growth factor~     agents.~   "
17760|NCT03334500|"~     Men with a history of prostate cancer may be in this study. Subjects recommended for a~     prostatectomy or oligometastectomy will undergo PET/CT imaging using a novel radiotracer~     [18F]FTT to evaluate PARP-1 activity in known or suspected sites of primary or metastatic~     disease. Imaging will be compared with pathology results, including additional research~     assays when possible.~   "
17761|NCT03334487|"~     A single-arm, open-label study to assess the overall safety of rovalpituzumab tesirine in~     participants with relapsed or refractory delta-like protein 3 (DLL3) expressing small cell~     lung cancer by evaluating the frequency of high grade (>= Grade 3) select treatment-emergent~     adverse events (TEAEs).~   "
17762|NCT03334474|"~     The process of population aging that is occurring in developed societies represents a major~     challenge for the health system. The aim of this study is to analyze factors that have an~     influence on early vascular aging (EVA), estimated by carotid-femoral pulse wave velocity~     (cf-PWV) and Cardio Ankle Vascular Index (CAVI), and to determine differences by gender in a~     Chinese population.~   "
17763|NCT03334461|"~     During orthodontic treatment intraoral corrosion results with release of nickel and titanium~     ions from orthodontic appliances in surrounding tissues. Those transported in the saliva and~     blood may cause a series of side effects from hypersensitivity reactions and soft tissue~     proliferation to cyto and genotoxicity. Nickel is one of the strongest contact allergens,~     present in numerous dental alloys. The aim of this project is to investigate the immune~     potential of nickel and titan ions (development of allergies, changes in cariogenic potential~     of dental plaque, resistance of gingivitis to therapy, and bacterial resistance to~     antibiotics) and changes in performance of orthodontic appliances with repercussion on~     regeneration of bone and periodontal tissues.~   "
17764|NCT03334448|"~     The study involves a comparison of a LY900014 U-200 formulation with a LY900014 U-100~     formulation. LY900014 is a type of fast acting insulin. Study participants will be~     administered LY900014 U-100 two times and LY900014 U-200 two times, over 4 study periods, by~     injection under the skin. Blood samples will be taken to compare how the body handles the~     study drugs and how they affect the blood sugar levels. Side effects and tolerability will be~     documented. The study will last about 4 weeks, not including screening and follow up.~     Screening is required within 28 days prior to the start of the study and follow up is~     required at least 2 weeks after the last dose of study drug.~   "
17765|NCT03334435|"~     The purpose of this study is to evaluate the long-term safety and efficacy of baricitinib in~     participants with atopic dermatitis.~   "
17766|NCT03334422|"~     The purpose of this study is to evaluate the efficacy and safety of baricitinib as~     monotherapy in participants with moderate to severe atopic dermatitis.~   "
17767|NCT03334409|"~     This randomized phase II trial studies how well pazopanib hydrochloride with or without~     ascorbic acid work in treating patients with kidney cancer that has spread to other places in~     the body or cannot be removed by surgery. Pazopanib hydrochloride may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. Ascorbic acid may help~     pazopanib hydrochloride stop tumor growth and improve treatment survival. Giving pazopanib~     hydrochloride and ascorbic acid may work better in treating patients with kidney cancer.~   "
17768|NCT03334396|"~     The purpose of this study is to evaluate the efficacy and safety of baricitinib as~     monotherapy in participants with moderate to severe atopic dermatitis.~   "
17818|NCT03333720|"~     Thirty eligible PKU patients (≥ 8 years), identified as tablet protein substitute users, will~     be recruited. Patients will firstly observe a 7-day baseline period, in which participants~     will continue with their existing diet, protein substitute and multi vitamin prescription.~     Patients will then receive PKU Lophlex Tablets daily for 28 days in addition to appropriate~     nutritional management. The aim of this prospective, single arm trial is to evaluate the~     acceptability (compliance, tolerance and palatability) of PKU Lophlex tablets in patients~     with proven PKU. The primary outcome measure is compliance, with secondary outcome measures~     of gastrointestinal tolerance, acceptability, blood amino acids, dietary intake,~     anthropometry and safety.~   "
17769|NCT03334383|"~     Laparoscopic surgery of the distal colon and rectum requires surgery with an appropriate~     field of view. A commonly used technique to create a clear exposure is the steep~     Trendelenburg position in which the patient is positioned in an angle of 15 to 40 degrees~     with the head down using the effect of gravity to retract the small intestine. This method is~     associated with haemostatic changes caused by the cranial shift of abdominal organs and~     blood. Recently, a cellulose compressed sponge was developed as intraoperative retractor,~     with the aim to keep the small intestines aside while the patient remains in a horizontal~     position. The safety of the sponge is secured with CE marking. The retractor sponge ensures a~     clear surgical field and potentially prevents haemostatic instability by avoiding~     Trendelenburg position. A pilot study in the St Antonius Hospital Nieuwegein has shown that~     use of the sponge might be associated with shorter hospital stay.~   "
17770|NCT03334370|"~     Diabetes mellitus (DM) and hypertension (HT) are major causes of morbidity and among the top~     10 causes of deaths in Hong Kong in 2008 (Department of Health 2009). The Hospital Authority~     (HA) has initiated service improvement through introducing the shared-care (SC) programme to~     improve the quality of care (QOC) for DM and HT patients. The evaluation on the QOC is an~     essential part of the programme in order to inform future policy. The Family Medicine Unit~     (FMU) of the University of Hong Kong (HKU) has been appointed by the HA to carry out the~     evaluation of the QOC of the programme.~      The Action Learning and Audit Spiral methodologies to measure whether the target standard of~     care intended by the SC programme is achieved. Each SC participating clinic and private~     medical practitioner (PMP) will be invited to complete a structured evaluation questionnaire.~     The data of all patients who have enrolled into the programme will be included in the~     evaluation on the process and outcomes of care. A hundred and thirty participants will be~     followed up by telephone to evaluate the effect of the programme in quality of life (QOL),~     patient enablement, and global rating of change in health condition at baseline and 6 months~     after enrolment. Data on the process of care will be retrieved from the HA medical records.~      Main Outcome Measures: The primary outcomes are the proportion of participants who received~     the criterion process of care and achieved a HbA1c level <7.5%.~      Data Analysis: Descriptive statistics on proportions of clinics or subjects meeting the~     quality of care criteria will be calculated. The outcomes of SC patients will be compared at~     6, 12, 24, 36 and 48 months by paired sample t-test. The outcomes between SC patients and~     control group will be compared by independent sample t-test or Chi-square test.~      Hypothesis: The QOC of the SC programme will be determined. Areas of deficiency and possible~     areas for quality enhancement will be identified. The results of this study will provide~     empirical evidence on whether the HA's SC programme can achieve equivalent QOC as the usual~     HA care for diabetes mellitus (DM) patients. The information will be used to guide service~     planning and policy decision making.~   "
17771|NCT03334357|"~     FIT-AGING will determine the effect of different exercise modalities on α-Klotho protein~     (primary outcome) in sedentary healthy adults. FIT-AGING also investigate the physiological~     consequences of activating Klotho gene (secondary outcomes).~   "
17772|NCT03334344|"~     A prospective, randomized, controlled study designed to assess whether digital virtual~     reality (VR) models, created from existing CT scans and MRIs, provide surgeons with an~     improved understanding of their patients' anatomy, resulting in more efficient operations~     (robotic partial nephrectomy) and improved patient care.~   "
17773|NCT03334331|"~     Introduction: The Obstructive Sleep Apnea (OSA) is characterized by obstructed superior~     airway during sleeping period promoting intermittent hypoxia-reoxygenation events. These~     events cause consequences such as cardiorespiratory and peripheric muscle structure~     alterations, which can cause reduction of the exercise tolerance. In this sense the~     continuous positive airway pressure (CPAP) is important to decrease the repercussions of the~     illness and cooperate to maintain the exercise functional capacity. To measure this capacity,~     one good option is the six-minute step test (6MST), that is low cost and submaximal, in~     addition to being adaptable and portable. However, there are doubts if it´s really capable to~     determinate the functional capacity of exercise of individuals with OSA treated with CPAP.~     Objective: Evaluate the validity and reproducibility of 6MST to determine the functional~     capacity of exercise in individual with OSA treated with CPAP and develop a model of a~     reference equation for the performance of the test in this population. Material and methods:~     This is an observational, prospective and cross-sectional study, in which will be evaluated~     132 volunteers (66 men and 66 women), with age between 18 and 65 years, diagnosed with OSA of~     moderate and severe degree, treated with CPAP for a minimum of three months, recruited of the~     ambulatory of pneumology of Otávio de Freitas Hospital. Initially will be collected personal~     and anthropometric information, answered to sleep questioners, quality of sleep and physical~     exercise, also respiratory muscle strength and lung function. The realization of the tests to~     evaluate the functional capacity of exercise will be done in two days with a maximum of seven~     days between the tests. In each day, the volunteers will do two 6MST and two six-minute walk~     test (6MWT), which order will be determined by randomization. Expected Results: It is~     expected that the 6MST to be showed as reproducible and capable to quantify the functional~     capability of exercise in individuals with OSA treated with CPAP.~   "
17774|NCT03334318|"~     Seven-point capillary profiles have shown that mean glucose correlates with both diabetic~     retinopathy and nephropathy risk. However, there remains great controversy as to whether the~     degree of variability around mean glucose may also contribute to these microvascular~     complications. The PERL trial (NCT02017171), testing whether treatment with allopurinol can~     slow down kidney function loss in type 1 diabetes, provides a unique opportunity to assess~     the role of glycemic variability in the progression of diabetic kidney disease in individuals~     who already have mild to moderate kidney disease. By applying Continuous Glucose Monitoring~     (CGM) in the PERL Study population, the investigators will be able to better understand how~     metrics of glycemia (mean, time above and below range, and various measures of variability)~     are associated with renal outcomes in the PERL population as a whole, but also in important~     subgroups (e.g., albuminuric vs. normoalbuminuric subjects with ongoing GFR decline,~     allopurinol vs. placebo arms). The nvestigators also aim to obtain precise information on the~     range of blood glucose corresponding to any given HbA1c value in this population since~     previous studies generally excluded patients with renal disease.~   "
17775|NCT03334305|"~     It is believed that the body's immune system protects the body by attacking and killing tumor~     cells. T-lymphocytes (T-cells) are part of the immune system and can attack when they~     recognize special proteins on the surface of tumors. In most patients with advanced cancer,~     T-cells are not stimulated enough to kill the tumor. In this research study, we will use a~     patient's tumor to make a vaccine which we hope will stimulate T-cells to kill tumor cells~     and leave normal cells alone.~      High grade gliomas (HGGs) are very aggressive and difficult for the body's immune system to~     attack. Before T-cells can become active against tumor cells, they require strong stimulation~     by special stimulator cells in the body called Dendritic Cells (DCs) which are also part of~     the immune system. DCs can recognize the cancer cells and then activate the T lymphocytes,~     and create this strong stimulation.~      The purpose of this research study is to learn whether anti-tumor T-cells and anti-tumor DC~     vaccines can be given safely. Most importantly, this study is also to determine whether the~     T-cells and DC vaccines can stimulate a person's immune system to fight off the tumor cells~     in the brain.~   "
17776|NCT03334292|"~     The purpose of the registry/repository is to provide a mechanism to store data and specimens~     to support the conduct of future research about Wilson disease (WD). The overall aim is to~     determine the optimal testing for diagnosis and parameters for monitoring treatment of WD~     that will aid product utilization and development.~   "
17779|NCT03334253|"~     Study Objectives~      The objectives for this randomized trial are:~        1. To determine the efficacy of daily low-dose atropine (0.01%) for slowing myopia~          progression over a two-year treatment period in children aged 5 to less than 13 years~          with myopia -1.00 to -6.00D at the time of enrollment (Primary Outcome On-Treatment).~        2. To determine the efficacy of atropine treatment on myopia progression 6 months following~          cessation of low-dose atropine treatment (Secondary Outcome Off-Treatment).~      Synopsis of Study Design The current study is designed as an efficacy study, making effort to~     maximize adherence to treatment group assignments. After a run-in phase during which all~     participants are treated with daily artificial tear eyedrops for 2-4 weeks (and glasses are~     updated if required) to assess their ability to adhere to daily eye drops, participants are~     randomly assigned to daily atropine or placebo for 24 months, followed by 6 months off~     treatment.~   "
17780|NCT03334240|"~     This study is intended to explore and evaluate the pharmacodynamics and clinical efficacy of~     the ionic contra-viral therapy CLS003 in immunocompromised and immunocompetent patients with~     benign and premalignant HPV-induced genital lesions~   "
17781|NCT03334227|"~     Severe sepsis leads a high morbidity and mortality by causing organ damage at distance. The~     treatment relies on early antibiotic therapy and hemodynamic resuscitation. Hypothesis: high~     flow nasal cannula (HFNC) could reduce work of breathing and improve the outcome of patients~     with severe sepsis and peripheral perfusion. Objective: the aim of this study is to evaluate~     the efficacy of HFNC for improving sixty-day survival in patients with severe sepsis. Design:~     multicenter parallel-group randomized clinical trial. Method: 592 adult patients with a~     diagnosis of severe sepsis in the first 6 hours of admission in the Emergency Room will be~     randomly assigned to an experimental or control group. In the experimental group, HFNC will~     be administered until the resolution of sepsis or until required mechanical ventilation,~     either invasive or non-invasive. In the Control group, conventional oxygen will be~     administered, if required. Sixty-day survival will be the primary outcome. The study is~     powered to demonstrate an improvement in survival from 70% in control group up to 80% in the~     HFNC group. The secondary outcomes will be reducing the need for vital support (mechanical~     ventilation, dialysis, vasoactive drugs) and physiological (acidosis, clearance of lactate,~     SvO2 and SOFA). Statistical analysis: Kaplan-Meier curves and Cox proportional hazard models~     will be calculated for all-cause sixty-day survival. If the results are conclusive, they will~     have immediate application in medical practice.~   "
17782|NCT03334214|"~     The purpose is to assess the Safety, Tolerability, and Pharmacodynamics effect of IONIS~     DGAT2Rx in up to 45 Adult Patients with Type 2 Diabetes.~   "
17783|NCT03334201|"~     The risk of developing cardiovascular diseases increases with aging largely due to~     age-related declines in the function of arteries (arterial dysfunction), which are influenced~     by common lifestyle factors such as consumption of a Western diet and lack of sufficient~     physical activity; thus, it is important to study how these factors interact to affect artery~     function. This study will determine whether changes to the gut microbiome (the collection of~     bacteria and other microbes living in the intestinal tract) with aging, Western diet~     consumption and aerobic exercise influence arterial function, and the biological pathways~     (mechanisms) involved. Specifically, the investigators will perform a randomized,~     single-blind, controlled feeding crossover study design (comparing Western diet to~     non-Western diet consumption) in young and older, exercising and non-exercising healthy~     adults to determine the time course effects (temporal association) of diet on the gut~     microbiome and arterial function. Overall, this research has potential to establish the gut~     microbiome as a possible target for treating/preventing age-related arterial dysfunction and~     reducing the risk of age-associated cardiovascular diseases.~   "
17784|NCT03334188|"~     The EPIC-HF study will test the effectiveness of a patient empowerment and activation for~     optimization of Heart Failure with reduced Ejection Fraction (HFrEF) medication plans. Three~     main regional centers in the UCHealth system will participate in a two-arm, randomized study~     design. In this design, each site participates in both control and intervention, with members~     of the sites eligible patient population randomly enrolled in either the intervention or the~     control arm. All eligible patients who agree to participate in the study will complete the~     Baseline Survey, the Follow-Up Survey, and will have information collected from their medical~     record at baseline, 1 month after the first clinic appointment post-enrollment, and 1 year~     after enrollment. Enrollment will take place at three UCHealth locations: UCHealth University~     of Colorado Hospital (Metro), UCHealth Medical Center of the Rockies and UCHealth Poudre~     Valley Hospital (North), and UCHealth Memorial Central and Memorial North (South). Study~     personnel at the North and South sites will carry out enrollment and Baseline Surveys with~     patients for those locations; all other study procedures will be conducted by study personnel~     at the University of Colorado (UC) School of Medicine (SOM) (UCSOM) at UCHealth University of~     Colorado School of Medicine.~      Patients enrolled in the intervention arm will receive, by email and/or text, a link to 1) a~     short patient engagement video around HFrEF medications, and 2) a link to an online PDF of a~     HFrEF medication checklist. Patients in the intervention arm will receive these materials~     after enrollment and one week prior to their next scheduled clinic appointment. The materials~     will be delivered in a second communication, three days after the first, via text, as well as~     a third communication on the day of the clinic appointment. Patients enrolled in the control~     arm will not receive any materials at any point of time and will receive their usual care.~      For both arms, medication changes in patient medical records will be assessed before and~     after clinic visits to measure the effectiveness of the intervention on aim 1; surveys will~     be compared before and after clinic visits to determine the effectiveness of the intervention~     on aim 2.~   "
17785|NCT03334175|"~     Prediabetes is a precursor of type 2 diabetes and an independent risk factor for~     cardiovascular disease, and currently affects one-quarter of the population of the United~     States. Individuals of overweight or obese BMI are at particular high risk for incident~     diabetes. A major modifiable risk factor for type 2 diabetes is poor dietary quality, and~     improvement of dietary quality can effectively delay and even prevent type 2 diabetes.~     Interventions to improve dietary quality thus far, however, rely on short-term intensive~     clinically designed meals replacing the entire diet which have poor sustainability.~     Persistent improvements to daily dietary patterns are often difficult without directed~     guidance, and overall dietary quality in the United States remains poor. The identification~     of a practical, daily dietary intervention to improve dietary quality and prevent diabetes in~     those at high risk remains unknown. The investigators propose to enroll 40 individuals with~     diagnosed prediabetes into a randomized controlled pilot study and provide a daily walnut~     supplementation intervention to determine feasibility and acceptability of the supplement.~     The investigators will then determine preliminary efficacy on metabolic markers and will~     investigate associations between dietary quality and circulating levels of branched-chain~     amino acids. The goal is to implement a whole-food supplement to improve dietary quality in~     patients with prediabetes as a tool for future type 2 diabetes prevention.~   "
17819|NCT03333707|"~     The study is designed to examine the efficacy of a mobile application implementation of~     existing best practices in mental health treatment for managing stress, anxiety, and~     depression.~   "
17786|NCT03334162|"~     Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and clinically~     relevant side-effect of cancer treatment. The severe symptoms such as loss of sensation,~     numbness, pain, absent reflexes or loss of balance control not only diminish children's~     quality of life but also affect the medical therapy. To date, there are no effective~     treatment options to reduce the symptoms of CIPN. Promising results have so far been achieved~     with specific exercise interventions.~      The investigators would therefore like to conduct a prospective, multicenter, two-armed trial~     (RCT with follow-up). Patients (N=20) will be recruited from the University Children's~     Hospital of Basel and the Hospital for Children and Adolescents, Kantonsspital Aarau. Prior~     to randomization, all primarily eligible patients that have received a platin derivate or~     vinca-alkaloid, will be screened for symptoms of CIPN. Eligible patients with a~     neurologically confirmed CIPN will then be randomized either into an intervention group or a~     control group (CG). Patients in the intervention group will perform a standardized,~     age-adjusted, specific playful sensorimotor training (SMT) program twice a week for 12 weeks~     in addition to usual care, while the control group receives treatment as usual. The CG will~     be given the opportunity to participate in the intervention after study completion. Data~     change will be assessed at 3 time points: At baseline (T0), after 12 weeks (post intervention~     testing, T1), and after 12 weeks of follow-up (T2). Primary endpoint is the Ped-mTNS score in~     order to subjectively as well as objectively assess the severity of CIPN symptoms. It~     contains a short questionnaire as well as more objective parameters such as light touch~     sensation, pin sensibility, vibration sensibility, deep tendon reflexes and muscular~     strength. Additionally, the CIPN symptom pattern will be assessed via nerve conduction~     studies, CIPN related pain, dorsiflexion and knee extension as well as postural control.~     Furthermore, investigators will be evaluating patients' level of physical activity, walk to~     run transition time, lower limb power as well as patients integration in physical education~     (PE) in school and sport club activities. The investigators hypothesize that patients in the~     intervention group will be able to reduce relevant symptoms of CIPN, improving related~     physical functions and enhancing children's social reintegration.~   "
17787|NCT03334149|"~     Raised blood pressure is a common problem in pregnancy. Raised blood pressure and~     pre-eclampsia affect about one in ten women and are a major cause of death and premature~     birth in the United Kingdom and worldwide.~      Many women have expressed an interest in monitoring their own blood pressure in between~     antenatal visits but there has been very little research to guide this. The investigators~     would like to know if the diagnosis and subsequent care of women with raised blood pressure~     can be improved if women were able to monitor their own blood pressure safely at home. This~     work will test whether optimising the diagnosis, monitoring and management of raised BP~     during pregnancy through self-monitoring of BP is effective, acceptable and cost-effective~     compared to usual care.~      The research team have being working with pregnant women, doctors and midwives to develop a~     simple and accurate method of self-monitoring of blood pressure in pregnancy.~      This randomised controlled trial will:~        1. Compare self-monitoring with usual care in women at higher risk of hypertension in~          pregnancy and assess if self-monitoring can identify raised blood pressure earlier.~        2. Compare self-monitoring with usual care for women with high blood pressure in pregnancy~          to see if it leads to lower blood pressure.~        3. Assess if self-monitoring is cost-effective.~      Pregnant women who chose to take part in these studies will be randomised to either usual~     care or asked to monitor their own blood pressure during their pregnancy in addition to their~     usual antenatal care.~   "
17788|NCT03334136|"~     The study evaluates the effect of oral vitamin D supplementation on the severity of psoriasis~     measured by Psoriasis Area Severity Index (PASI) in adults with lower vitamin D levels. Half~     of the participants will receive vitamin D, while the other half receive placebo.~   "
17789|NCT03334123|"~     The aim of the study is to determine the effect of functional exercise and training~     counseling by kinesiotherapist in addition to the basic exercise program of cycling during~     dialysis on physical performance of dialysis patients.~   "
17790|NCT03334110|"~     Apply a new operation method of Left Internal Mammary Artery (LIMA)-Greater Saphenous Vein~     (GSV)-SCVBG to the treatment of patients with diffuse coronary artery disease,through~     clinical randomized controlled study,compared with patients of bilateral internal mammary~     artery (BIMA)-SCVBG and evaluate both of therapeutic effects and prognosis.~   "
17791|NCT03334097|"~     The aim of this research is to study the responsiveness of the Spanish Version of Wijma~     Delivery Expectancy/Experience Questionnaire, Version A (WDEQ-A) in pregnant women after an~     educational intervention.~   "
17792|NCT03334084|"~     The study is a Randomized, Open-label, Parallel Group Study to Compare the Pharmacokinetics,~     Pharmacodynamics and Safety and Tolerability of a Subcutaneous Formulation With an~     Intravenous Formulation of ARGX-113 in Healthy Male Subjects~   "
17793|NCT03334071|"~     Trial Phase: Pilot~      Indication: Stage IIIB/IV NSCLC~      Primary Objective: To assess the feasibility and tolerability of exercise training during~     palliative chemotherapy.~      Secondary Objective: 1) To assess fitness levels in patients undergoing palliative~     chemotherapy, and to explore whether exercise training can prevent a reduction in fitness.~      2) To determine the baseline fitness, as assessed by cardiopulmonary exercise testing (CPET),~     of a cohort of patients with stage IIIb/IV non small cell lung cancer who are about to~     initiate treatment with chemotherapy 3) To compare patients enrolled in the EMBRACE~     randomized controlled trial (RCT) with those who decline.~      4)To investigate any relationship between baseline fitness and outcomes including therapy~     related complications, response, and survival in those patients who decline exercise training~     or are randomized to observation.~      5) To assess the feasibility of the translation of in-hospital exercise training to~     home-based training during chemotherapy.~      6) To document the effects of chemotherapy on cellular energetics and mitochondrial function.~      Rationale: Chemotherapy has a detrimental effect on physical fitness, and this effect can be~     later reversed by training. The investigators wish to understand the mechanism of this~     detrimental effect, and investigate whether it can be prevented or attenuated by giving~     chemotherapy concurrently with exercise training.~      Trial Design: Randomised controlled study (1:1) comparing chemotherapy alone, with~     chemotherapy plus exercise training. A subgroup of patients will have muscle biopsies.~     Patients who decline randomisation will be offered enrolment into an observational arm.~      Sample size : 100 patients (to include 48 who will be randomised, and 52 in the observational~     arm).~   "
17794|NCT03334058|"~     The proposed study is an open-label, non-controlled, adaptive-design Phase II study to~     evaluate the safety, pharmacodynamics, pharmacokinetics, efficacy, and conditions of use~     (dosage, frequency of administration at maintenance) of ARGX-113 in patients with mild to~     moderate Pemphigus Vulgaris, either newly diagnosed or relapsing.~      The total study duration for each patient is approximately 19 weeks. It consists of a maximum~     Screening period of 2 weeks, an Induction treatment period of 3 weeks, a Maintenance~     treatment period of 6 weeks and a treatment-free Follow-up (FU) period of 8 weeks.~   "
17795|NCT03334045|"~     INTRODUCTION: Stress is one of the greatest burdens of our society and often imply~     impairments in cognitive and emotional functions. The investigators hypothesize that changes~     in the brain's dopamine(DA)-based mesocorticolimbic projections in patients with work-related~     stress (adjustment disorder) will manifest in altered glucose metabolism in relation to~     neural activity and altered DA radiotracer binding potential at neurotransmitter and receptor~     level.~      MATERIAL AND METHODS: Subjects and healthy controls undergo neuropsychiatric tests and PET/MR~     imaging with three tracers: [18F]FDG to measure glucose metabolism as a marker of neural~     activity, [11C]raclopride to investigate the DA binding potential in the striatum, and~     [11C]FLB 457 to study possible impaired mesocortical dopaminergic transmission. To~     demonstrate difference in glucose metabolism ≥2x41 patients/controls are needed.~      OUTCOME: The investigators expect to find that symptoms of cognitive and motivational/reward~     deficits could be attributable to changes in frontal lobe and striatal glucose metabolism in~     >50% of patients and that changes in striatal D2 receptors and impaired mesocortical~     dopaminergic transmission in the prefrontal cortex are contributing factors.~      CONCLUSION: This project aims to generate entirely new and objective evidence of~     stress-induced cerebral illness and provide a basis for in depth research and more rational~     management of this strenuous disorder.~   "
17796|NCT03334032|"~     The study aimed to assess protein accretion during weight gain in adolescent patients with~     Anorexia nervosa~   "
17797|NCT03334019|"~     Diseases naturally transmitted between animals and humans (zoonoses) are one of the leading~     causes of emergence or re-emergence of human infectious diseases. Non-foodborne zoonoses are~     commonly transmitted to human directly by contact with infected animals or contaminated~     environment. People working with animals such as farmers and veterinarians are particularly~     at risk of infection. Some zoonoses can also be transmitted indirectly thought the air and~     therefore can affect the general population. Example is Q fever, a disease caused by Coxiella~     burnetii, a bacterium highly resistant in the environment.~      In Western France, Q fever is endemic in cattle herds. To improve human zoonotic disease~     surveillance, the investigators will conduct a population based study in this area.~      The aims of the study are:~        1. To assess seroprevalence of Coxiella burnetii infection among general population,~          farmers and veterinarians in Western France~        2. To identify risk factors for Coxiella burnetii seropositivity in these populations~   "
17798|NCT03334006|"~     The purpose of this study is to test the adjuvant Immuneglobulins G, A and M (IgGAM)~     treatment for:~        1. An improvement of the outcome for the patient's peritonitis. This will be investigated~          by using scores such as the multiple organ failure (MOF) and Sequential Organ Failure~          Assessment (SOFA) scores as well as survival data.~        2. Identification of biomarkers [Ig level, procalcitonin (PCT), interleukin-6 (IL 6), Human~          Leukocyte Antigen - antigen D Related (HLA DR), nuclear factor~          kappa-light-chain-enhancer of activated B cells (NF kB1), adrenomedullin (ADM), pathogen~          spectrum], to identify patient subpopulations that profit most from treatment with~          IgGAM. Such patients will comprise the basis for a further study, which will be a~          randomised, controlled, double-blind trial (RCT) to demonstrate the value of this~          treatment.~        3. Furthermore, these biomarkers are expected to help with developing a personalised~          adjuvant therapy with IgGAM in the indication of peritonitis.~   "
17799|NCT03333993|"~     Breast cancer is the most frequent tumor site among women in the world (FERLAY et al., 2015).~     In Brazil, estimates for the year 2017 indicate the occurrence of about 57,960 new cases~     (56.2 cases per 100,000 women); (Brazil - Ministry of Health, 2015). The increase in adjuvant~     therapies resulted in an estimated increase of 22 million cancer survivors worldwide~     (GOLDSTEIN et al., 2012). However, as survival rates increased, more women faced~     complications related to diagnosis and treatment (ABRAHMS et al., 2016). Adjuvant~     radiotherapy is a frequent treatment in breast cancer and fatigue it is the main adverse~     effects (HICKOK et al., 2005). Measures of intervention through physical activity have shown~     benefits in the increase of the functional capacity that generates a reduction of effort and~     decrease of the fatigue (MARKES et al., 2009). General Objective: To evaluate the influence~     of Mat Pilates on fatigue, quality of life, functional capacity, flexibility, lymphedema,~     radiodermatitis and depression, in the women with breast cancer and with an indication of~     adjuvant radiotherapy, at the Cancer Hospital III of the National Cancer Institute (INCA).~     After recruitment, women will be allocated randomly in: Intervention Group (Mat Pilates and~     usual activities) and Control Group (usual activities). Patients in the intervention group~     will be submitted to 10 sessions of Mat Pilates for a period of 5 weeks (from beginning to~     end of adjuvant radiotherapy). Patients assigned to the control group will not participate in~     the Mat Pilates program, but will maintain the usual exercises for upper limbs, guided by~     physiotherapists in the postoperative period. In both groups, patients will be submitted,~     functional capacity assessment, flexibility assessment, assessment of the presence of~     lymphedema, and questionnaire application of fatigue, quality of life, level of physical~     activity and depression. Will be performed a descriptive analysis of the population.~     Univariate logistic regression will be performed between the outcomes according to the~     exercise groups and also, for the possible confounding variables. The variables with p<0.20~     will be selected for adjustment in the construction of the multiple logistic regression~     model. Those with p<0.05 and/or with clinical significance will be maintained in the model.~   "
17800|NCT03333980|"~     A non-interventional observational clinical study to document the clinical course of patients~     at 12 months or more following an ischaemic stroke~   "
17801|NCT03333967|"~     The investigators conduct the real world study to explore the efficacy and safety of Apatinib~     in gastric cancer .~   "
17802|NCT03333954|"~     In this study, the principle functionality of the device will be tested in humans for the~     first time. The study will evaluate the extent to which patients with atrophic dry age~     related macular degeneration (AMD) have evoked light perception using the implant.~   "
17803|NCT03333941|"~     The overall purpose of this continued access study is to allow ongoing treatment of subjects~     at selected investigational sites while the marketing application for the ReCell® Autologous~     Cell Harvesting Device is under FDA review. This is a prospective, multicenter, single-arm~     observational study to evaluate the safety and clinical performance of the ReCell® device~     when used as an adjunct to meshed autografts in patients with acute thermal burn injuries~     requiring skin grafting for closure.~   "
17804|NCT03333928|"~     This study evaluates HTD1801 in the treatment of Primary Sclerosing Cholangitis (PSC) in~     adults. The subjects will be randomised to 3 treatment groups, to receive 500mg, 1000mg and~     placebo, bid.~   "
17805|NCT03333915|"~     This study is designed to evaluate the safety, tolerability and PK profile and treatment~     Effect of BGB-290 in Chinese advanced cancer subjects.~   "
17806|NCT03333902|"~     The purpose of this study is to investigate the effect of different kinds of popular~     peripheral nerve blocks for postoperative analgesia after cesarean delivery is completed,~     compared with traditional epidual analgesia..~   "
17820|NCT03333694|"~     The purpose of this first in human and proof of concept study is to characterize the safety,~     tolerability and initial efficacy of CLL442 in patients with Squamous Cell Carcinoma in situ~     (SCCis) to enable further clinical development of CLL442.~   "
17809|NCT03333850|"~     The aim of this study is to investigate if patients hospitalised for medical disease will~     increase their time spent out of bed during hospitalisation through simple feedback about~     physical activities from a mobile device.~      Physical activity is measured by means of a pair of accelerometers embedded in band aids~     placed on the thigh and on the chest. The measurement is continuous and data is uploaded to a~     secure internet-server. Summaries of physical activity (bedrest, sitting, standing, walking)~     is computed and can be displayed on a mobile device (tablet) through a dedicated application.~      The study will be conducted as a controlled cohort study in a large tertiary public hospital~     in Copenhagen, Denmark. Patients admitted to Department of Respiratory Medicine will be~     included and will have their physical activity measured during hospitalisation. Half of the~     cohort will receive visual feedback about the amount of physical activity from a mobile~     device placed on the bed table.~      A total of 108 patients will be included resulting in 6 periods of 18 patients each.~   "
17810|NCT03333837|"~     Dementia is a progressive decline in cognition that impairs a person's ability to perform~     activities of daily living. Changes in mood, gait, and balance are prominent secondary~     symptoms of Alzheimer's dementia that can dramatically decrease quality of life for the~     person with dementia and increase caregiver burden. The overall aim of this study is to~     determine the independent and combined effects of dance movement and social engagement on~     quality of life in people with early-stage dementia, and test the neural mechanisms of these~     effects.~   "
17811|NCT03333824|"~     The purpose of this study is to determine whether AZD1775 has any effect on the~     pharmacokinetics (PK) of three compounds (caffeine, omeprazole, and midazolam) that are~     probes for common drug-metabolizing enzymes (caffeine-CYP1A2, omeprazole-CYP2C19,~     midazolam-CYP3A). The study also seeks to determine the effect of AZD1775 on the QTc~     interval, which is a common measure of cardiac (heart) function.~   "
17812|NCT03333798|"~     Female survivors of domestic violence (DV) may exhibit various mental health problems. A~     variety of psychotherapies are available to improve their mental health, however there is~     uncertainty on which is the best. In Colombian, national guidelines do not mention which~     therapy should be used and in practice, psychologists use their preferred approaches. Due to~     the shortage of psychotherapy appointments, patients wait a long time to initiate treatment~     and for each subsequent appointment. Furthermore, patients with mental health problems often~     fail to attend their appointments and often drop-out of their psychotherapy. This study will~     offer an alternative intervention that is hypothesized to be superior to normal patient care~     in Colombia. It will be conducted in Cali and Tuluá, which have high levels of DV, internally~     displaced conflict victims and large socioeconomic inequalities. Psychologists and trained~     Lay Psychosocial Community Workers (LPCWs) will work together to provide a~     cognitive-behavioral intervention (CBI) for female survivors of DV, which is a therapy that~     aims to change the way people think and behave. Each woman will be offered 11 weekly sessions~     which will be shared between a psychologist and a LPCW. The LPCW will assign tasks to the~     patients which have been set by the psychologist and will assist participants to attend their~     appointments. The study´s hypothesis is: 1) A psychologist led CBI with LPCW support is~     superior to standard psychotherapy care in Colombian health services to improve mental health~     symptoms of female survivors of DV.~      Patients will be recruited from health services and will be randomly assigned to either the~     standard psychotherapy or the CBI with LPCW support (intervention group). In the standard~     psychotherapy group, patients will receive psychotherapy approximately every four weeks,~     depending on demand, and will have as many sessions as they require. In the intervention~     group, patients will be offered eleven weekly CBI sessions. Mental health questionnaires will~     be used to measure the study participants' mental health symptoms, their functionality,~     experience of DV and other forms of violence. In the intervention group, these questionnaires~     will be applied before initiating psychotherapy, two weeks and six months after completing~     their psychotherapy. Patients in the control group will have questionnaires applied before~     commencing psychotherapy and fourteen weeks and twenty-two weeks after starting.~   "
17813|NCT03333785|"~     Improving Cancer Care Together through eOncoNote is a pragmatic randomized trial involving a~     secure online eConsultation system (referred to as eOncoNote) that will allow primary care~     providers and cancer specialist providers to communicate about their patients.~   "
17814|NCT03333772|"~     Feasibility of a Complex Behavioral Intervention for Young Adults with Diabetes: The~     Resilient, Empowered, Active Living-Telehealth (REAL-T) Study will evaluate the feasibility~     of implementing a diabetes management intervention via telehealth in preparation for a~     large-scale randomized controlled trial (RCT) entitled Evaluation of a Complex Behavioral~     Intervention for Young Adults with Diabetes: The Resilient, Empowered, Active~     Living-Telehealth (REAL-T) Study.~   "
17815|NCT03333759|"~     This study is examining the effects of the 2940 nm Er:YAG on atrophic facial acne scars under~     optical coherence tomography in terms of blood flow, vessel shape, skin roughness, collagen~     content, and epidermal thickness.~   "
17816|NCT03333746|"~     This phase II trial studies how well lenalidomide and nivolumab work in treating patients~     with multiple myeloma that has come back or does not respond to treatment. Drugs used in~     chemotherapy, such as lenalidomide, work in different ways to stop the growth of cancer~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Monoclonal antibodies, such as nivolumab, may interfere with the ability of cancer~     cells to grow and spread. Giving lenalidomide and nivolumab may work better in treating~     patients with multiple myeloma.~   "
17817|NCT03333733|"~     Tackling obesity is a public health priority. Childhood obesity is of particular concern due~     to its impact on physiological and psychological health and likelihood of tracking into~     adulthood, with associated diseases and disorders and financial burden to the NHS. Once~     established, obesity is hard to treat. Therefore, prevention strategies aimed at children are~     essential.~      This study aims to determine the feasibility of undertaking a full trial to evaluate the~     clinical effectiveness of the HENRY (Health, Exercise, Nutrition for the Really Young)~     programme in preventing childhood obesity. It is a multi-centre, open labelled, two group,~     prospective, cluster randomised, controlled, feasibility study aiming to recruit 120 parents~     from 12 Children's Centres.~      HENRY (Health, Exercise, Nutrition for the Really Young) is an 8 week community based~     intervention delivered in settings such as Children's Centres, aimed at preventing childhood~     obesity by supporting families to make positive lifestyle changes. It is currently widely~     delivered across the UK. Preliminary data indicates that HENRY may be effective at reducing~     childhood obesity and improving family health, although a robust evaluation has not yet been~     conducted. A good deal of public money has already been used to develop and commission HENRY~     and it is essential to demonstrate clear benefits of the programme before further funding.~     This study will determine whether a definitive randomised controlled trial (RCT) of HENRY is~     feasible. 12 Children's Centres will be recruited from two local authorities. From these,~     half will be randomised to deliver HENRY programmes.~      From the participating Children's Centres, 120 parents will be recruited. All participants~     will be asked to meet with a researcher twice in their home, 12 months apart. During the~     visit, parents will complete 4 questionnaires around diet and lifestyle. Height and weight~     measurements will also be taken from the parent (optional) and child (compulsory). The~     decision of whether a RCT is feasible will be based on whether it is possible to recruit~     local authorities, children's centres and parents to take part; ensure staff can be~     adequately trained to deliver programmes within specified timeframes; and whether proposed~     data can be adequately gathered.~   "
17927|NCT03332290|"~     within the components of Scuba diving there are similarities with meditation and mindfulness~     techniques. PTSD and emotion dysregulation are known to be involved by meditation training~     This study evaluates the benefits of scuba diving on quality of life and mindful functioning~     comparing the benefits of diving training using a clinical trial protocol~   "
23801|NCT03255408|"~     A prospective double blind, placebo-controlled, randomized cross-over trial to evaluate the~     effect of lowering cerebral blood flow on the ventilatory chemoreflexes (acute hypoxic and~     hypercapnic ventilatory responses).~   "
17821|NCT03333681|"~     1. Objectives: Evaluation of mesenchymal stem cell therapy effects on cellular immune~          response in refractory rheumatoid arthritis (RA) patients.~        2. Design: This study has been performed as a phase 1 clinical trial.~        3. Setting and conduct: Autologous bone marrow derived mesenchymal stem cells were obtained~          by bone marrow aspiration and cultured in Minimum Essential Medium-Alpha (MEM-alpha) for~          4 weeks in standard clean room and then transfused to RA patients intravenously.~        4. Participant's major eligibility criteria is as follows: Ten refractory rheumatoid~          arthritis patients who show resistance to non biological Disease-modifying antirheumatic~          drugs (DMARDs) after 6 to 12 months have been enrolled in this study.~        5. Intervention: A single dose of intravenous autologous bone marrow derived mesenchymal~          stem cells have been administered into patients with resistance to non-biological~          DMARDs.~        6. Main outcome measures (variables): Finding of mesenchymal stem cell therapy effects on~          the cellular immune responses.~   "
17822|NCT03333668|"~     This is not a clinical trial. The aim of this study is to understand the mechanism of action~     of two recently licensed drugs for ADHD on brain function. We will compare the brain~     activation changes elicited by Guanfacine extended release (GXR; a non-stimulant drug) with~     the brain activation changes elicited by Lisdexamfetamine (LISDEX; a stimulant drug) and by~     placebo in 20 drug−naïve patients with ADHD using functional Magnetic Resonance Imaging~     (fMRI). For this purpose we intend to scan participants during their performance of tasks of~     attention, working memory, and inhibition, which we know from previous studies to elicit~     abnormal brain activation patterns in ADHD patients (Rubia et al., 2005; Smith et al., 2006).~   "
17823|NCT03333655|"~     The purpose of this study is to identify mechanisms associated with acquired immune escape by~     comparing baseline and at-progression tissue samples from participants who derive clinical~     benefit from CPI treatment of metastatic cancer or hematologic malignancies.~   "
17824|NCT03333642|"~     This study evaluate the Duodenal Ileal Interposition with Sleeve Gastrectomy for Type 2~     Diabetes Mellitus in grade 1 obesity and overweight patients.~   "
17825|NCT03333629|"~     Autism spectrum disorder (ASD) is defined by impaired social engagement and social~     communication, and repetitive, restricted, or stereotyped behaviors and interests. The~     average age of diagnosis in the US is after the fourth birthday. However, children who start~     ASD-specific early intervention have better outcomes than children start later. The current~     study will address a gap identified by the US Prevention Services Task Force, namely that~     children detected through screening respond positively to early intervention. This study will~     directly relate early detection strategies to early intervention, and measure the impact of~     age of intervention onset on outcomes when children are entering kindergarten. Local~     pediatric providers will be randomized to provide either usual care, or to an experimental~     condition in which autism early detection strategies are enhanced through the addition of~     specific procedures. Across all sites, 8,000 children will be recruited through their~     participating pediatric practice. Qualifying children will receive up to one year of early~     intensive behavioral intervention, after getting an ASD diagnosis. Primary outcome measures~     will include children's cognitive functioning and ASD symptom severity, which will be~     measured at multiple time points. The investigators predict that this study will inform early~     detection strategies which will result in improving children's social and cognitive~     functioning, mitigating lifespan disability, reducing societal costs, and improving personal~     well-being and productivity of individuals with ASD.~   "
17826|NCT03333616|"~     This research study is studying a combination of drugs as a possible treatment for rare~     genitourinary malignancies.~      -The names of the study drugs involved in this study are:~        -  Nivolumab~        -  Ipilimumab~   "
17827|NCT03333603|"~     To evaluate the pharmacokinetic and safety for the esomeprazole use for schizophrenia~   "
17828|NCT03333590|"~     The proposed clinical trial study of rAAVrh74.MCK.GALGT2 for duchenne muscular dystrophy~     (DMD) patients. There will be a modified intravascular limb infusion (ILI) procedure that~     will be used to sequentially deliver vector to each whole lower limb of DMD subjects via a~     major lower limb artery.~   "
17829|NCT03333577|"~     The purpose of this study is to gather clinical performance data on the Baha SoundArc~   "
17830|NCT03333564|"~     The effect of vitamin D3 and omega-3 Fatty acids on estradiol levels.~   "
17831|NCT03333551|"~     This is a pilot study designed to assess for relative change in cardiac 18F Florbetapir~     uptake in patients with AL cardiac amyloidosis after appropriate chemotherapy.~   "
17832|NCT03333538|"~     The purpose of this study is to evaluate immunogenicity and safety of medicinal product~     GamEvac-Lyo- Vector-Based Vaccine against Ebola Virus Disease~   "
17833|NCT03333525|"~     The study investigated the effects of fat protein counting (CFP) in addition to carbohydrate~     (CARB) counting for calculating prandial insulin dosage on blood glucose profile in patients~     with type 1 diabetes (T1D) on basal-bolus insulin therapy.~   "
17834|NCT03333512|"~     The aim of this study is to examine the neurobehavioural and glucose metabolic responses to~     two successive cycles of sleep restriction and recovery in adolescents, and to determine the~     benefits of napping on cognitive performance, alertness, mood and glucose metabolism. Using a~     split-sleep design, 60 participants, aged 15 to 19 years old, are divided into a nap and a~     no-nap group. Both groups undergo two cycles of sleep restriction and recovery over a period~     of 15 days. The no-nap group receives a 6.5-hour sleep opportunity on sleep restriction~     nights, with no daytime nap opportunity. The nap group receives a 5-hour sleep opportunity on~     sleep restriction nights, and has a 1.5-hour nap opportunity the following afternoon.~   "
17835|NCT03333499|"~     The investigators set out to evaluate the effects of the traditional Chinese medicinal~     mixture under the brand name YangXinShi (YXS) on the prognosis in patients with chronic heart~     failure when it is combined with the optimal combination drug treatment of heart failure.~   "
17863|NCT03333122|"~     The purpose of the study is to learn more about the quality of life and satisfaction with~     breast cancer surgical treatment and education from patient reported outcome data. The data~     and information obtained from breast cancer patients can be invaluable in counselling~     patients with a new diagnosis of breast cancer on their expected outcomes and results. The~     hypothesis is that using prospectively obtained data to guide surgical decision-making and~     optimize access to surgical procedures would improve the treatment of patients and would most~     likely positively impact the health-related quality of life in patients.~   "
17836|NCT03333486|"~     This phase II trial studies how well fludarabine phosphate, cyclophosphamide, total body~     irradiation, and donor stem cell transplant work in treating patients with blood cancer.~     Drugs used in chemotherapy, such as fludarabine phosphate and cyclophosphamide, work in~     different ways to stop the growth of cancer cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Radiation therapy uses high energy~     x-rays to kill cancer cells and shrink tumors. Giving chemotherapy and total-body irradiation~     before a donor peripheral blood stem cell transplant helps stop the growth of cells in the~     bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also~     stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem~     cells from a donor are infused into the patient they may help the patient's bone marrow make~     stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may~     also replace the patient?s immune cells and help destroy any remaining cancer cells.~   "
17837|NCT03333473|"~     The primary goal of PPFP Choices is to generate actionable evidence that can be used to~     increase programmatic activities to address post-pregnancy family planning in the public and~     private-for-profit sectors. The ultimate intent of this investment is to advance and scale up~     post-pregnancy FP. Programmatic learning will be crucial to understanding what it will take~     to accelerate post-pregnancy FP in these two countries, and these can later be adapted by~     other countries with similar settings. Our vision of PPFP Choices can be achieved through the~     following objectives:~        -  Objective 1: Establish a comprehensive program implementation framework for the private~          sector to embrace post-pregnancy FP~        -  Objective 2: Improve the quality of post-pregnancy FP counseling and service provision~          in both public and private sectors~        -  Objective 3: Build evidence and contribute to the literature and programmatic guidance~          around post-pregnancy FP uptake and continuation in both public and private sectors~        -  Objective 4: Ensure effective documentation and strategic dissemination which will~          benefit post-pregnancy FP introduction and scale-up more broadly~   "
17838|NCT03333460|"~     Background: Cocaine use disorders (CUD) is a complex brain disorder, involving several brain~     areas and neurocircuits. Effective treatments for CUD are still needed. Repetitive~     transcranial magnetic stimulation (rTMS) stimulates non-invasively parts of the brain.~     Preliminary data suggest that rTMS may help reducing cocaine craving and consumption.~     Researchers want to learn how the brain and the drug-seeking behavior may change with this~     treatment.~      Objectives: To test if rTMS can reduce cocaine craving and use, and also affect several mood,~     behavioral and cognitive alterations associated with prolonged cocaine use.~      Eligibility: Healthy, right-handed adults ages 18-65 who do have cocaine use disorder~     (moderate to severe).~      Design: This is a randomized, double-blind, sham-controlled study. The study includes three~     phases: 1) a rTMS continued treatment phase; a rTMS follow-up; and a no rTMS follow-up.~      Prior to participating, participants will be screened with:~        -  Questionnaires~        -  Medical history~        -  Physical exam~        -  Urine tests~        -  MRI (structural)~      After being enrolled, baseline behavioral and imaging data will be collected. In particular,~     participants will undergo:~        -  Questionnaires~        -  Functional MRI~      During the continued rTMS phase, participants with cocaine use disorder will be randomized to~     receive real or fake rTMS. Repetitive TMS will be delivered during 10 outpatient treatment~     days, over 2 weeks (5 days/week). Following this phase, subjects will have 12 follow-up~     visits (once/weekly), during which they will receive rTMS, and behavioral and imaging~     assessments will be performed. At the end of the rTMS follow up period, participants will~     further receive 3 follow up visits (once a month), during which rTMS will not be performed,~     but behavioral data will be collected.~      Treatment includes:~        -  rTMS: A coil is placed on the head. A brief electrical current passes through the coil.~          At each visit, participants will receive two rTMS sessions, with a 1hr interval between~          sessions. At the beginning of each rTMS session, they view cocaine-related images for~          few minutes.~        -  MRIs at baseline and at follow-up visit #12: Participants lie on a table that slides~          into a cylinder that takes pictures of the brain. They respond to images while in the~          scanner.~        -  Repeat of screening tests and questionnaires~        -  Urine toxicological screen~   "
17839|NCT03333447|"~     This study with standardized reading MRIs, will provide for the first time objective and~     quantified data on organomegaly (liver and spleen volumes) as well as bone alteration (Bone~     Marrow Burden11) of French patients treated with VPRIV®. These data will help to better~     assess the impact of this treatment on these parameters.~      The result of this study will also answer in part to the request of the French Transparency~     Commission (CT: Commission de Transparence) of the French National Health Authority to~     provide them with data of French patients treated with VPRIV®.~   "
17840|NCT03333434|"~     Ankle foot orthoses (AFO) are frequently used to improve locomotor skills of cerebral palsied~     children (CP) although the level of scientific evidence to support their use is still~     moderate. Carbon Ankle Seven spring (A7 - Otto Bock, Germany) is specifically designed to~     store energy when loaded and release it at toe-off in order to improve gait performance with~     respect to non-energy-storing AFOs. The aim of this work is to verify the superiority of the~     ankle-7 orthosis compared to the more widespread AFO, to improve the functionality and~     walking function of children with spastic diplegia and PCI.~   "
17841|NCT03333408|"~     Salivary duct stent placement is a common practice to maintain duct patency after salivary~     duct repair or interventional sialendoscopy; procedures performed to manage salivary duct~     pathology such as stenosis, traumatic injury or most commonly salivary duct stones. It is~     common practice for patients to receive perioperative antibiotics while undergoing~     interventional sialendoscopy and postoperative oral antibiotic therapy with Clindamycin or~     Augmentin for 10-14 days, if a short term (2 week) salivary duct stenting was considered~     necessary due to the nature of the intervention. However, In reviewing the literature, there~     are controversial trials that indicate post-operative antibiotics may not be best practice in~     all surgical scenarios, as the adverse events ie. gastrointestinal disturbances, nausea,~     Clostridium difficile (C.diff) infection and antibiotic resistance over time surrounding~     overuse of antibiotics may outweigh the clinical need for the antibiotic regiment and the~     chances of post-operative infection.~   "
17861|NCT03333148|"~     The central focus of this trial is to understand the effectiveness of Preoperative~     Immunonutrition (PINT) in improving surgical outcomes for patients with inflammatory bowel~     disease (IBD). We hypothesize that PINT will reduce post-operative complications in IBD~     patients undergoing elective surgery with added improvements in length-of-stay (LOS), quality~     of life (QOL) and patient satisfaction. As a secondary focus, the investigator will aim to~     better understand the potential mechanism-of-action by which PINT may have its effects~     through analyses of biomarkers including inflammatory markers, nutritional proteins and the~     fecal microbiome.~   "
17862|NCT03333135|"~     This research is being done to better understand the pulmonary consequences of completing an~     ultra marathon at altitude and a sea level city.~   "
17864|NCT03333109|"~     The purpose of this study is to evaluate the efficacy and safety of AMG334 in countries~     beyond the United States (US) and European Union (EU).~   "
17842|NCT03333395|"~     Chronic Obstructive Pulmonary Disease (COPD) is the fourth leading cause of mortality in the~     world in 2015. COPD is a progressive disease and is associated with periods of increasing~     severity-acute exacerbation- (AECOPD) (1). The main pathophysiologic causes of AECOPD is the~     peribronchial inflammation (2), excessive secretions and mucosal swelling that add more~     narrowing to the already narrowed bronchial tree and the creation of a hypercoagulable state~     that lead to fibrin deposition in the microcirculation of the lung and the alveoli (3) which~     eventually cause both pulmonary hypertension (4) and impairment of the balance between~     ventilation and perfusion (4, 5). Mechanical ventilation is a life saving measure in managing~     AECOPD, despite the wide spread use of non-invasive positive pressure ventilation (NPPV) in~     the management of AECOPD (6), NPPV is not always suitable for the management of AECOPD and~     may be associated with 70% risk of intubation (7), moreover, NPPV is contraindicated in many~     cases (e.g. cardiac or respiratory arrest, impaired mental state, upper airway obstruction~     and uncooperative patients). In such cases patients should be intubated and mechanically~     ventilated (1).~      Many studies showed the role of heparin and other anticoagulants in reducing fibrin~     deposition in the lungs and hence the improvement of the clinical outcome (8). Beside its~     anticoagulant effect, heparin decreases the adherence of bacteria and viruses to bronchial~     surface, inhibits leukocytic activation and decreases pulmonary edema (9). Nebulized heparin~     has a beneficial effect over the parenteral administration due to the reduction of the~     incidence of systemic bleeding and the enhancement of heparin delivery to bronchial tree and~     the alveoli (5, 10). Many studies demonstrated the effective use of nebulized heparin in a~     variety of pulmonary situations (11), notably, attenuation of pulmonary coagulopathy in~     critically ill patients with acute lung injury (12). In healthy volunteers, nebulized heparin~     reached the lower respiratory tree, induced a local anticoagulant effect and was evenly~     spread over the lung (13). Nebulized heparin is absorbed rapidly and released gradually into~     the systemic circulation through the capillary-alveolar membrane causing a dose-dependent~     increase in activated partial thromboplastin time (APTT) however, without any risk of~     bleeding indicating its relative safety (12).~      C-Reactive Protein (CRP) is a strong and independent predictor of future COPD outcomes, and~     provide valuable incremental prognostic information in COPD patients (14).~   "
17843|NCT03333382|"~     Standard endoscopic management for anastomotic bile leaks following OLT has been endoscopic~     retrograde cholangiopancreatography (ERCP) with placement of a temporary plastic biliary~     endoprosthesis (stent) across the site of anastomotic leak. While this intervention carries a~     high rate of technical success, clinical success is not universal. An alternative to~     placement of a plastic biliary stent is placement of a fully covered self-expanding metal~     stent (FCSEMS). Whereas a plastic stent functions largely as a wick to siphon bile flow, the~     theoretical advantage of a FCSEMS is that the relatively larger expansile diameter and~     membrane coating provide an actual and effective seal at the site of leak. FCSEMS have been~     used successfully for salvage therapy of anastomotic bile leaks in the post-OLT population~     with no serious stent related adverse events and no cases of unsuccessful FCSEMS removal in~     this population.~      The objective of this study is to prospectively randomize patients found to have anastomotic~     bile leaks following OLT to placement of either a plastic biliary stent or a FCSEMS at~     initial ERCP intervention.~   "
17844|NCT03333369|"~     The dopamine hypothesis of schizophrenia implies that alterations in the dopamine system~     cause functional abnormalities in the brain that may converge to aberrant salience~     attribution and eventually lead to psychosis. Indeed, widespread brain disconnectivity across~     the psychotic spectrum has been revealed by resting-state functional magnetic resonance~     imaging (rs-fMRI). However, the dopaminergic involvement in intrinsic functional connectivity~     (iFC) and its putative relationship to the development of psychotic spectrum disorders~     remains partly unclear - in particular at the low-end of the psychosis continuum. Therefore,~     the investigators examined dopamine-induced changes in striatal iFC and their modulation by~     psychometrically assessed schizotypy. The randomized, double-blind placebo-controlled study~     design included 54 healthy, right-handed male participants. Each participant was assessed~     with the Schizotypal Personality Questionnaire (SPQ) and underwent 10 min of rs-fMRI~     scanning. Participants then received either a placebo or 200 mg of L-DOPA, a dopamine~     precursor. The investigators analyzed iFC of six striatal seeds that are known to evoke~     modulation of dopamine-related networks.~      The investigators hypothesized that, within the L-DOPA treatment group, the striatal iFC~     would be disrupted due to increased availability of dopamine. The investigators further~     hypothesized that individuals with high schizotypal scores would show a disruption of~     striatal connectivity, as has been reported with schizophrenia. In addition, the~     investigators hypothesized that the L-DOPA-dependent change in striatal iFC would interact~     with the severity of positive symptoms, as has been found in previous studies in non-clinical~     psychosis. The investigators anticipated this symptom-dependent change, especially in the~     ventral striatal regions, because these are thought to modulate cortico-striatal loops~     associated with cognition and emotion.~   "
17845|NCT03333356|"~     This is a randomized multicentre study in patients with high-risk MIBC to investigate~     adjuvant radiotherapy after radical cystectomy and pelvic lymph node dissection.~      The objective of the study is to provide evidence that adjuvant radiotherapy improves~     loco-regional control with potential benefits in survival. The study will also evaluate the~     quality of life of patients and the tolerance of the treatment.~   "
17846|NCT03333343|"~     The study purpose is to evaluate the safety, tolerability, and preliminary efficacy of the~     addition of INC280, trametinib, ribociclib, gefitinib, or LXH254 to EGF816 in adult patients~     with advanced EGFR-mutant NSCLC.~   "
17847|NCT03333330|"~     Background-White matter hyperintensities (WMH), patchy areas of hyperintense signal on~     T2-weighted or Fluid Attenuated Inversion Recovery sequences on brain magnetic resonance~     imaging (MRI), are believed to reflect cerebral burden of ischemic damage and are associated~     to incident stroke, dementia and eventually mortality in otherwise healthy subjects. Also~     brain atrophy has been related with presence of carotid atherosclerosis and vascular~     cognitive impairment. Carotid atherosclerosis may contribute to the genesis of WMH. A recent~     meta-analysis by our group comprising 5306 subjects was able to demonstrate an association~     between the presence of carotid atherosclerosis and WMH (odds ratio, OR, 1.42, 95% confidence~     interval [CI] 1.22-1.66).~      Objective-To evaluate the relation between carotid artery plaque characteristics,~     cardiovascular risk factors and brain atrophy/WMH burden analyzed quantitatively as number~     and volume of lesions and as brain volumes, and progression over 18 months of follow up in~     subjects asymptomatic for cerebrovascular disease with a carotid artery stenosis <70%.~   "
17848|NCT03333317|"~     The purpose of this study is to determine in hospitalized infants and children who are~     infected with respiratory syncytial virus (RSV) the dose-response relationship of multiple~     regimens of lumicitabine on antiviral activity based on nasal RSV shedding using quantitative~     real-time reverse transcriptase polymerase chain reaction (qRT-PCR).~   "
17849|NCT03333304|"~     The aim of the study is to demonstrate if using one procalcitonin (PCT)-guided rule of stop~     of antimicrobials, the incidence of infections by C.difficile and by Multi-Drug-Resistant~     (MDR) bacteria during the next six months may be significantly decreased.~   "
17850|NCT03333291|"~     The study will characterize the biology of FMT in the context of IBS prior to wider clinical~     application of the method. Given the ethical concerns of unknown and long-term adverse~     effects of FMT therapy, the study will include patients only with moderate to severe~     symptoms. IBS is a heterogenous disorder and it is important to characterize the patients,~     and study as homogeneous patient populations as possible. Therefore the study will only~     include post-infectious IBS patients after the Giardia outbreak.~   "
17851|NCT03333278|"~     The global burden of sepsis is substantial with an estimated 15 to 19 million cases per year~     and the vast majority of these cases occur in low income countries.With more timely diagnosis~     and improvement in supportive care the 28-day mortality from sepsis in high income countries~     has declined to about 25%, however, the mortality from septic shock remains as high as 45%.~     Moreover, the mortality from sepsis and septic shock in low income countries is reported to~     be as high as 60%. New therapeutic approaches to sepsis are required; considering the global~     burden of sepsis these interventions need to be effective, cheap, safe and readily available.~      A large body of experimental data has demonstrated that both corticosteroids and intravenous~     vitamin C attenuate the release of pro-inflammatory mediators, reduce the endothelial injury~     characteristic of sepsis (thereby reducing endothelial permeability and improving~     microcirculatory flow), augment the release of endogenous catecholamines and enhance~     vasopressor responsiveness.~      Therefore, the investigators plan to conduct a feasibility pilot prospective, multi-centre,~     randomised, open-label, trial in 126 ICU patients with septic shock to test whether the~     intravenous administration of high dose Vitamin C (6g/d), Thiamine (400mg/d) and~     Hydrocortisone (200mg/d) leads to a more rapid resolution shock and vasopressor dependence.~   "
17852|NCT03333265|"~     In recent years, Berberine hydrochloride has been reported to inhibit cancer cell~     proliferation and to be cytotoxic towards cancer cells. Patients with familial adenomatous~     polyposis have a nearly 100 percent risk of colorectal cancer. The aim of this study is to~     investigate the chemopreventive effects Berberine hydrochlorid on the regression of~     colorectal adenomas.~   "
17853|NCT03333252|"~     The proposed study will develop and test the efficacy and feasibility of a dyadic-based~     intervention program (DT), delivered through state-of-the art computer tablet technology. A~     novel feature of the investigation is its focus on both the caregiver and the recipient of~     care (person with AD) and the integration of an evidenced-based caregiver intervention and~     evidenced-based cognitive/functional training for the care recipient. The program will be~     tailored for the caregiver and emphasize issues important to caregivers, not only in the~     earlier stages of caregiving, but will also target issues across the caregiving trajectory to~     help prepare the caregiver for changes in their role. Two hundred and forty Hispanic, African~     American and White/Caucasian dyads will be randomized to the DT intervention or Control~     condition. Measures at baseline and the 6 and 12-month follow-ups will include indices of~     care recipient cognitive and functional status, and caregiver outcomes such as; quality of~     life, distress, and caregiving efficacy. Information will also be gathered on ethnic~     differences in response to the intervention and estimates of cost effectiveness of the~     intervention.~   "
17854|NCT03333239|"~     The current study will evaluate and compare the effectiveness of cognitive-behavioral and~     psychodynamic therapy. Therefore 420 children and adolescents (ages 8-16 years) with~     depression and/or anxiety disorder will be randomly assigned to a treatment or a control~     condition. The intervention´s short-term effectiveness and sustainability as well as~     cost-effectiveness will be examined over a 5 year period for each participant.~   "
17855|NCT03333226|"~     Breast cancer related lymphedema (BCRL) is a debilitating and distressing condition affecting~     approximately one out of five breast cancer survivors. BCRL is a chronic swelling of the~     upper arm following axillary lymph nodes dissection, and it is associated to a significant~     functional, psychological and social morbidity, with an heavy impact on life quality. Several~     studies reported BCRL incidence between 6.7% and 62.5% for different population cohorts.~     Randomized clinical trials (RCTs) reported that sentinel lymph node biopsy (SLNB) when~     compared with axillary lymph node dissection (ALND) leads to a significant reduction in~     postoperative complications. However, the advent of SLNB does not solve the problem of BCRL~     with a concrete chance to develop a lymphedema after single SLNB around 7%. Health care cost~     of BCRL rehabilitative treatment is not available in literature yet. Few studies considered~     incidence, risk factors and treatment costs of BCRL among working-age women after breast~     cancer treatment, reporting that BCRL population had significantly higher rehabilitative~     medical costs ($14,877 to $23,167) with twice as much risk to develop BCRL complications,~     such as lymphangitis or cellulitis when compared to BCRL free population (OR = 2.02, P =~     .009).~      Axillary reverse mapping (ARM) procedure claims to map and preserve arm lymphatic drainage~     during ALND and/or during SLNB, reducing BCRL development. ARM is developed as result of~     assumption that arm's lymphatic pathway is not involved by metastatic tumor cells of the~     primary breast cancer. However, when the arm lymph node correspond to the SLN it should be~     removed for correct tumor staging, thus a lymphatic drainage disruption onset will be~     expected with BCRL risk increase.~      During the ARM procedure, a fluorescence imaging technique (photodynamic procedure) is useful~     for detecting lymphatic drainage of the upper limb and it allows in differentiating the~     fluorescent ARM node from the SLN identified by the radioguided technique (99mTC-Nanocoll).~   "
17856|NCT03333213|"~     Chronic low back pain is a major public health burden with only limited evidence of~     effectiveness for complementary and traditional therapies. Gua Sha is a traditional East~     Asian therapy traditionally used in the treatment of spinal pain. This study aimed to test~     the efficacy of Gua Sha therapy in patients with chronic low back pain A total of 50 patients~     with chronic low back pain were randomized to either two Gua Sha treatments (n=25) or a~     waitlist control group (n=25). Primary outcome measure was current pain intensity on a 100-mm~     visual analog scale; secondary outcome measures included back-related function (Oswestry~     Disability Index), movement-related pain (modified Pain on Movement Questionnaire), as well~     as pressure pain threshold, mechanical detection threshold, and vibration detection~     threshold.~   "
17857|NCT03333200|"~     The purpose of this study is to understand the course of rare genetic disorders that affect~     the brain. This data is being analyzed to gain a better understanding of the progression of~     the rare neurodegenerative disorders and the effects of interventions.~   "
17858|NCT03333187|"~     The present study will be a multicenter, prospective phase II-study comparing efficacy of~     allogeneic SCT for patients with myelofibrosis who have a suitable stem cell donor after a 3~     months Ruxolitinib induction therapy with patients who lack a suitable stem cell donor and~     will continue to receive Ruxolitinib.~   "
17859|NCT03333174|"~     To determine if servo-controlled oxygen environment is associated with reduction in (a)~     bradycardia events, (b) hypoxemic time, (c) bradycardia time, (d) apneic episodes~   "
17860|NCT03333161|"~     To determine if late (at or beyond postnatal day 14) mild permissive hypercapnia is~     associated with reduction in apnea, bradycardia, and hypoxemic episodes and with improved~     stability of oxygenation.~   "
17975|NCT03331653|"~     This study will compare the effect of dry needling on the active trigger point on~     sternocleidomastoid versus the effect of dry needling at 1.5 centimeters of active trigger~     point on sternocleidomastoid, both combined with ischemic compression, on cervical pain and~     cervical motor control short and medium term.~   "
17865|NCT03333096|"~     The aim of this study is to measure fitness to drive in patients with a visual and a~     cognitive impairment. To do so, Ocusweep is used in patients with glaucoma and Mild Cognitive~     Impairment. The participants will be divided over four groups; patients with glaucoma,~     patients with cognitive impairment, patients with both and a healthy control group.~     Differences in performance on Ocusweep in the four different groups of participants are~     expected. These effects may be related to fitness to drive, which is why those results will~     be compared to traditional neuropsychological measures of fitness to drive. the hypothesis of~     the current study is that the Ocusweep performance is related to performance on other~     measures of fitness to drive.~   "
17866|NCT03333083|"~     Phase 3b, single arm, simplification study with dual therapy including Lamivudine (300 mg QD)~     plus Raltegravir (1200 mg QD) in virologically suppressed HIV-1 infected patients~     experiencing inconvenience, toxicity, negative impact on comorbidities or risk of drug-drug~     interactions with their current regimen.~   "
17867|NCT03333070|"~     Functional constipation (FC) is a common condition in childhood, with an estimated prevalence~     of 0.7% to 29%.The diagnosis and treatment of FC can be difficult tasks, and children are~     often referred to specialist services causing treatment to become expensive and~     time-consuming.The standard treatment based on osmotic laxatives (mainly PEG). The recovery~     rate is 50% to 60% after 1 year of treatment, with 50% of the children having relapse within~     5 years. Studies in adults have established the effectiveness of some lactic acid bacteria in~     the treatment of chronic constipation.~   "
17868|NCT03333057|"~     This study will evaluate the efficacy, safety and tolerability of perfluorohexyloctane~     (NOV03) at two different dosing regimens compared to saline solution in subjects with Dry Eye~     Disease (DED).~   "
17869|NCT03333044|"~     The goal of this study is to evaluate the effectiveness and implementation process of a~     multi-level, integrated intervention to decrease HbA1c among South Asians with uncontrolled~     diabetes, including four components: 1) an EHR-based registry function to increase~     identification of South Asian patients with uncontrolled diabetes; 2) CHW-led health coaching~     of registered patients to promote health behavior change; 3) HIT-enabled and CHW-facilitated~     identification and referral to culturally relevant community resources for patients; and 4)~     HIT-enabled care coordination between the CHW and other members of the healthcare team.~   "
17870|NCT03333031|"~     HS-196 is near infrared red (NIR)-tethered HSP90 inhibitor for clinical imaging of selective~     tumor binding. HS-196 consists of a HSP90 inhibitor that binds competitively to the Hsp90 ATP~     binding domain connected by a linker to a contrast agent (near infrared (NIR) dye) that can~     be used for imaging. HS-196 can freely enter tumor cells to selectively bind Hsp90. Due to~     the the NIR dye, HS-196 accumulation in the malignant cells allows for specific visualization~     of tumors within the body.~   "
17871|NCT03333018|"~     DUS1 and DUS2 are descriptive drug utilisation studies in new users of aclidinium bromide in~     Europe.~      The objectives of DUS1 and DUS2 are to describe the characteristics and patterns of use of~     new users of aclidinium bromide (monotherapy or in combination) and new users of other~     medications for chronic obstructive pulmonary disease (COPD); to evaluate the potential~     off-label use of aclidinium bromide; to describe users of aclidinium bromide in subgroups of~     patients for whom there is missing information in the risk management plan (RMP); and to~     establish a core cohort of new users of aclidinium bromide for the future evaluation of~     safety concerns described in the RMP.~      The data source for these studies will be the CRPD in the UK, the GePaRD in Germany, and~     national health databases in Denmark.~   "
17872|NCT03333005|"~     An open-label, multi-center, Phase Ib study to determine the safety and pharmacokinetics of~     intravenous and oral APX001 in patients undergoing chemotherapy for Acute Myeloid Leukemia~     with neutropenia.~      A total of 20 patients will be enrolled in this study. 10 patients in Cohort I, intravenous~     drug dosing and 10 patients will be enrolled in Cohort II, oral drug dosing.~      All patients will receive chemotherapy for their AML according to local clinical standard of~     care as well as antifungal prophylaxis.~      APX001 will be administered for 14 consecutive days, beginning on Study Day 3 after onset of~     chemotherapy~   "
17873|NCT03332992|"~     This project is a partnership between Emmi Solutions, a private company that delivers health~     promotion messages to employees of client organizations, and the University of Michigan and~     affiliated academic investigators. In particular, Emmi sends out pre-recorded and interactive~     telephone calls on behalf of their healthcare clients to promote influenza vaccination each~     Fall. The collaboration will design various scripts (based on established risk communication,~     behavior change, and behavioral economic principles) to be pre-recorded and sent out on these~     calls on a randomized basis (with approval by client organizations), with the number of arms~     to vary based on the size of each client's participant list (to ensure sufficient statistical~     power within each client's sample). Emmi will deliver the calls and track individual~     responses to questions posed during the call. Emmi will then provide a de-identified dataset~     to the academic research team for analysis to determine whether any scripts provided greater~     or lesser effects to people's their motivations to get a flu vaccination.~   "
17874|NCT03332979|"~     The course of dementia over many years, gradual losses and uncertain life expectancy can lead~     to grief amongst family and friend carers. This study aims to examine the relationship~     between carers' feelings of grief before the death of a person with dementia and how well~     carers are prepared for that death. The study involves completing questionnaires with 150~     carers of people with dementia (at home or in a care home). Twenty of these carers will be~     purposively selected to complete additional semi-structured questions to further explore the~     research questions. The questionnaires will examine whether being prepared for end of life is~     linked to having lower levels of grief. Preparation will be measured by important factors~     shown in research including: knowledge of dementia progression; knowledge of the person with~     dementia's end of life preferences; communication with healthcare professionals; family~     support; and having a Power of Attorney or advance directives. The study is part of a larger~     study that will also involve surveys with service providers and developing a resource for~     carers. The study will provide important insights into how we can better support grieving~     carers and help them plan and prepare for end of life care.~   "
17976|NCT03331640|"~     The aim of the study is to assess the efficacy of second and third line therapies (OFF vs.~     FOLFIRI) in a sequential cross-over design in patients pretreated with~     nab-paclitaxel/gemcitabine first line.~   "
17875|NCT03332966|"~     This study aims to identify unusual experiences and psychiatric symptoms that indicate a~     heightened risk for severe mental disorders - especially psychoses. It is important to~     develop reliable questionnaire methods that are cost-effective in first-stage screening,~     leading to in-depth assessments and targeted care. However, existing psychosis-risk~     questionnaires are limited in content, intended for adults, and have been insufficiently~     tested for actual predictive value. Therefore we will collect a new, large dataset from an~     unselected group of adolescents entering psychiatric care in three major urban areas of~     Finland. Comprehensive national health care registers will be used to assess how well the~     selected experiences and symptoms predict the participants' mental health over the following~     few years.~   "
17876|NCT03332953|"~     Despite the explosive popularity of sweet flavored electronic cigarettes, there is little~     empirical evidence regarding how sweet flavors interact with different levels of nicotine~     to reduce its perceived bitterness and harshness, and thereby increase its appeal and~     additive potential. This study will serve to fill this knowledge gap through empirical~     psychophysical data that will determine the association between sweet flavor and nicotine and~     its link to the acceptance and rejection of vaped nicotine.~   "
17877|NCT03332940|"~     This is a prospective, open-label, multicenter, safety, comparative study of IV administered~     Tc99m-tilmanocept and unfiltered Tc99m sulfur colloid in the detection of and assessment of~     three dimensional tessellation localization to the liver in subjects with and without~     moderate to severe nonalcoholic steatohepatitis (NASH) by planar and SPECT/CT imaging.~      This study is designed to evaluate the safety and tolerability of Tc99m-tilmanocept in~     subjects with NASH.~   "
17878|NCT03332927|"~     The objective of this trial is to assess the effects of whole egg consumption (12 per week),~     compared to energy-matched typical breakfast control foods, on insulin sensitivity and other~     markers of metabolic health, including fasting lipoprotein lipid levels and resting blood~     pressure.~   "
17879|NCT03332914|"~     This crossover designed study evaluates the effects of microcurrent therapy on knee~     osteoarthritis. Ín a previous study patients were randomized into four different groups.~     Group 1 and 2 both received microcurrent therapy, but with different freqency and intensity~     parameters. Group 3 received treatment with the microcurrent treatment apparatus without~     current (sham). group 4 was a control group.~      In the following, present study the controll group as well as the sham group will receive the~     microcurrent therapy (verum).~   "
17880|NCT03332901|"~     General anesthesia may predispose patients to aspiration of gastroesophageal contents because~     of depression of protective reflexes during loss of consciousness. The laparoscopy would~     increase the intra-abdominal pressure, which is regarded as a predisposing factor of~     gastroesophageal reflux during the anesthesia. The lower esophageal sphincter is the~     important physiological mechanisms that prevent regurgitation and aspiration. However, the~     change of LES pressure and gastroesophageal reflux before and after laparoscopic~     physiological condition is still unknown because the prospective evaluation of~     gastroesophageal function in human is limited. In addition, the relationship between the~     change of intra-abdominal pressure and the LES pressure were still unknown, too. In this~     study, we aimed to observe the changes of gastroesophgeal function parameters by esophageal~     manometry, pH impedance, and intra-abdominal pressure measured by AbViser ®AutoValve®IAP~     Monitoring Device before and after laparoscopic condition.~   "
17881|NCT03332888|"~     The study is a phase II single-centered, single group, prospective clinical trial to evaluate~     the safety of HMA-CD20 doses among stable patients with class III/IV according to the NYHA~     classification with HFrEF receiving standard of care therapy. The index qualifying HFrEF must~     have EF &lt; 40% based on echocardiographic or cardiac MRI techniques, heart failure class~     III/IV according to the NYHA classification,aged 40-60 years, being diagnosed less than 12~     months before enrollment of study, following the standard heart failure treatment regimen.~   "
17882|NCT03332875|"~     The purpose this study is to determine the continued reach and effectiveness of the~     OurRelationship.com program once paid advertising and payment for participation ceases. The~     answer to this question is essential to determining the sustainability of web-based~     interventions for couples. Specifically, this study has four aims:~        1. Examine continued level of initial interest in the study, as measured by number of~          initial visits to the website, time spent on the page, and number of couples signing up~          for the study.~        2. Measure any changes in the characteristics of the individuals expressing interest in the~          study, including demographics (e.g., race, ethnicity, education), relationship~          functioning (e.g., relationship satisfaction, previous help-seeking), and individual~          functioning (e.g., depression, anxiety)~        3. Determine completion rates and effectiveness of the program once payments for~          participation have been removed.~        4. Determine whether having a single Skype/phone call with a coach (rather than the four~          calls that were used in the NIH trial) significantly degrades completion rates.~   "
17883|NCT03332862|"~     Acute efficacy of point-by-point radiofrequency ablation for pulmonary vein isolation in~     patients with atrial fibrillation are comparable independantly of the ablation strategy~     (continous versus discontinuous ablation) under the same condition of power delivery.~   "
17884|NCT03332849|"~     This is a phase 1 multiple ascending dose (MAD) study, conducted in subjects with Type 1 and~     Type 2 diabetes mellitus~   "
17885|NCT03332836|"~     This is a phase 1 multiple ascending dose (MAD) study, conducted in subjects with Type 2~     Diabetes Mellitus.~   "
17895|NCT03332706|"~     The aim of the study was to define the possible association between heavy iron level and the~     consequence of pregnancy especially spontaneous abortion and missed abortion. The study~     population will comprised the first-trimester pregnant women in the PUMCH (Peking Union~     Medicine College Hospital) during 2017 October to 2018 November. We categorised the patients~     into two groups, the study group where the patients suffered from spontaneous abortion or~     missed abortion, and the control group where the patients carry the normal live fetal for at~     least 8 weeks and ask for artificial abortion. All the cases included in the study were~     examined with respect to 6 kinds of heavy iron level in venous blood and urine, then~     correlation analysis was applied to define heavy iron level between two groups.~   "
17896|NCT03332693|"~     The aim of this study is to determine whether individuals differ one from the other in their~     genetic, cellular, systemic, structural and functional response to acute exercise.~   "
17886|NCT03332823|"~     Aims: To enhance mental well-being of adults by creating a positive, happy and joyful~     environment in the community.~      Targets: Adults aged 18-59 in Hong Kong.~      Methods: SME Ambassadors Pilot Project will adopt the public health and family-focused~     approach, under the brand name of Joyful@HK Campaign. Evidence-based and Evidence~     Generating approach with vigorous study design, both qualitative (e.g. focus groups) and~     quantitative (e.g. pre- and post- test), will be used to evaluate the overall programme~     effectiveness including follow-up of at least one month (best science). To ensure the~     practicability and sustainability of the community-based engagement project, we will engage~     community partners with strong track records of best practice to design, plan, and~     implement the intervention. This project will use innovative and integrated positive~     psychology and public health theories and methods to plan brief, simple, and cost-effective~     intervention.~      Significance: By using best science in the design and evaluation of intervention programme,~     and the best practice of the partners' skills, experience and strong connection with~     service targets in the community, the intervention, if proven to be effective, for promoting~     sharing, mind and enjoyment and enhancing mental well-being can be further developed and~     widely disseminated to and adopted by the practitioners in the health and social service~     sectors for replication and improvement to benefit the whole population.~   "
17887|NCT03332810|"~     Aims: To enhance mental well-being of adolescents, adults and their families by creating a~     positive, happy and joyful environment in the community.~      Targets: Adults aged 18-59 and their family members in Hong Kong.~      Methods: Healthy Community Pilot Project will adopt the public health and family-focused~     approach, under the brand name of Joyful@HK Campaign. Evidence-based and Evidence~     Generating approach with vigorous study design, both qualitative (e.g. focus groups) and~     quantitative (e.g. randomised controlled trial), will be used to evaluate the overall~     programme effectiveness including follow-up of at least one month (best science). To ensure~     the practicability and sustainability of the community-based engagement project, we will~     engage community partners with strong track records of best practice to design, plan, and~     implement the intervention. This project will use innovative and integrated positive~     psychology and public health theories and methods to plan brief, simple, and cost-effective~     intervention.~      Significance: By using best science in the design and evaluation of intervention programme,~     and the best practice of the partners' skills, experience and strong connection with~     service targets in the community, the intervention, if proven to be effective, for promoting~     sharing, mind and enjoyment and enhancing mental well-being can be further developed and~     widely disseminated to and adopted by the practitioners in the health and social service~     sectors for replication and improvement to benefit the whole population.~   "
17888|NCT03332797|"~     This study will evaluate the safety, pharmacokinetic (PK), pharmacodynamic (PD) activity, and~     preliminary anti-tumor activity of GDC-9545 as a single agent and in combination with~     palbociclib and/or luteinizing hormone−releasing hormone (LHRH) agonist in patients with~     advanced or metastatic estrogen receptor (ER)-positive (human epidermal growth factor~     receptor 2 [HER2]-negative) breast cancer.~   "
17889|NCT03332784|"~     The purpose of this study is to investigate safety, tolerability, and pharmacokinetics of~     TAK-925 when a single dose of TAK-925 is administered to healthy adult participants, healthy~     elderly participants and patients with type 1 narcolepsy.~   "
17890|NCT03332771|"~     Primary Objective:~      To demonstrate the non-inferiority of sotagliflozin dose 1 compared to glimepiride on HbA1c~     (glycosylated A1c) reduction in patients with T2D (type 2 diabetes) who have inadequate~     glycemic control with metformin.~      Secondary Objectives:~      To demonstrate the superiority of sotagliflozin dose 1 compared to glimepiride on change in~     body weight, SBP (systolic blood pressure) in patients with baseline SBP ≥130 mmHg, SBP in~     all patients, and proportion of patients with at least 1 documented symptomatic hypoglycemic~     event (≤70 mg/dL).~        -  To demonstrate the superiority of sotagliflozin dose 1 compared to placebo on change in~          HbA1c, body weight, SBP in patients with baseline SBP ≥130 mmHg, SBP in all patients.~        -  To demonstrate the superiority of sotagliflozin dose 2 compared to placebo on change in~          HbA1c.~        -  To demonstrate the non-inferiority of sotagliflozin dose 2 compared to glimepiride on~          change in HbA1c.~        -  To demonstrate the superiority of sotagliflozin dose 1 compared to glimepiride on change~          in HbA1c.~        -  To evaluate the safety and tolerability of sotagliflozin compared to glimepiride and~          placebo.~   "
17891|NCT03332758|"~     Prospective study evaluating the role of inflammasomes in cell death in retinal detachment,~     full thickness macular hole, and epiretinal membrane. The investigators are collecting~     vitreous and subretinal fluid samples from patients with these conditions and evaluating~     activity of the inflammasome pathway with established assays.~   "
17892|NCT03332745|"~     Aortic stenosis is the most common heart valve disease requiring intervention in high income~     countries. It is characterised by progressive valvular thickening, and restriction as well is~     hypertrophy and fibrosis of the left ventricle in response to pressure overload. The~     pathological processes in the left ventricle that ultimately result in heart failure and~     death are incompletely understood. Further elucidation of these processes and how they~     correlate with novel blood biomarkers may help us design new treatments and optimise the~     timing of surgical intervention.~      In brief, recruited patients with severe aortic stenosis and scheduled to undergo valve~     replacement surgery will be invited for some simple tests (blood sampling, ECG,~     echocardiogram). A septal myocardial biopsy will be taken at the time of surgery and the~     disease valve retained. These will be examined histologically and pathological changes~     compared with results obtained from ECG, echocardiogram and blood tests.~   "
17893|NCT03332732|"~     This is a 2-part, drug-drug interaction study to evaluate potential PK interactions after~     single doses in Part 1 and multiple doses in Part 2. In Part 1, subjects will receive single~     dose of 5 treatments in a cross-over design; in Part 2 subjects will receive treatment for 10~     days.~   "
17894|NCT03332719|"~     The purpose of this study is to asses the compared efficacy, safety and immunogenicity of~     ENERCEPTAN® with ENBREL® in combination with Methotrexate for the treatment of patients with~     rheumatoid arthritis.~   "
17922|NCT03332355|"~     The primary objectives of this study are to determine the maximal tolerated dose (MTD) of~     PAC-1 in combination with temozolomide in patients with high grade glioma: glioblastoma~     multiforme (GBM) or anaplastic astrocytoma after progression following standard first line~     therapy (Component 2), by evaluation of toxicity and tolerability.~   "
17897|NCT03332680|"~     In Vitro Fertilisation (IVF) is an increasingly common treatment for infertility. Clinics~     which offer IVF are continuously trying to improve their success rates, measured by the~     numbers of IVF cycles which result in the birth of a live baby.~      One factor which is thought to have contributed to the success of IVF is the improvements in~     the embryo culture media, that is, the fluid in which the embryo resides in the laboratory~     before being replaced into a woman's womb. This trial seeks to identify if IVF cycles in~     which a particular culture media called EmbryoGlue is used have better results when compared~     to IVF cycles in which a conventional embryo transfer media is used.~   "
17898|NCT03332667|"~     131I-Metaiodobenzylguanidine (131I-MIBG) is one of the most effective therapies utilized for~     neuroblastoma patients with refractory or relapsed disease. In this pediatric phase 1 trial,~     131I-MIBG will be given in combination with dinutuximab, a chimeric 14.18 monoclonal~     antibody. This study will utilize a traditional Phase I dose escalation 3+3 design to~     determine a recommended phase 2 pediatric dose. An expansion cohort of an additional 6~     patients may then be enrolled.~   "
17899|NCT03332654|"~     Objective: To report the prevalence and risk factors of stress urinary incontinence (SUI) and~     the prevalence of intrinsic sphincter deficiency in women with multiple sclerosis (MS).~     Methods: A retrospective study was conducted among Female patients with MS, followed for~     lower urinary tract symptoms (LUTS) during a 15-year period. Demographic data, MS history,~     expanded disability status scale (EDSS) score at the urodynamic visit, obstetrical past,~     birth weight, LUTS, and urodynamic findings were collected. SUI was defined as incontinence~     during cough, or any effort. A maximum urethral closure pressure less than 30 cm H2O defined~     intrinsic sphincter deficiency. Results: In total 363 women with a mean age of 46.7±10.8~     years and a mean disease duration of 12.9±8.7 years were included. The incidence of relapsing~     remitting MS, a secondary progressive form, and a primary progressive form was 60.6%, 32.8%,~     and 6.6%, respectively. The prevalence of SUI was 31.4%. The prevalence of intrinsic~     sphincter deficiency was 1.4% and 0.8% of these patients had a SUI (P=0.300). In a~     multivariate analysis, women with a SUI had significantly higher birth weight (P=0.030), a~     pelvic organ prolapse (P=0.021), urgent urinary incontinence (P=0.006), a lower EDSS score~     (P=0.019), and a weaker containing effort (P<0.001). Conclusions: The prevalence of SUI in~     women with MS was 31.4%. This symptom could affect the quality of life of women with MS.~   "
17900|NCT03332641|"~     This study was conducted to investigate the effects of daily supplementation of Citron(Citrus~     Junos Siebold ex Tanaka) Peel Extract on improvement of Blood Cholesterol.~   "
17901|NCT03332628|"~     The study to be performed will define the rate of skin barrier recovery following microneedle~     treatment of the skin in healthy subjects of differing racial/ethnic backgrounds.~   "
17902|NCT03332615|"~     Patients with advanced illness and their families confront a number of issues ranging from~     distressing symptoms to making complex decisions that affect quality of life and survival.~     Patients and family members struggle with these decisions even more when they feel~     ambivalence or reluctance. The investigator's overarching goal is to enhance provision of~     high quality, patient-centered care for patients with advance illness and their families and~     to reduce burnout among palliative care clinicians. The investigator will apply a~     well-established approach to achieving clinician/patient alignment in the primary care~     setting, Motivational Interviewing (MI) to a new population and setting, palliative care.~   "
17903|NCT03332602|"~     Food fortification has shown to be efficacious to alleviate the burden of micronutrient~     deficiencies. Ensuring the bioavailability of iron and maintaining the sensory quality and~     stability of the fortified food and other added micronutrients remains a challenge. Soluble~     iron compounds cause minor organoleptic changes in foods but their bioavailability in man is~     rather low. Water-soluble iron compounds, such as ferrous sulphate (FeSO4), are the compounds~     in which the iron is most bioavailable; however, they often cause unfavorable sensory~     changes.~      Encapsulation of iron has excellent potential for overcoming unwanted sensory changes and~     iodine losses in salt, while maintaining acceptable bioavailability. In the present project,~     we would like to investigate the iron bioavailability from a new formulation of encapsulated~     iron sulphate based on hyaluronic acid (HA) and a polymer from the eudragit family.~   "
17904|NCT03332589|"~     This is a Phase 1 study of E6201 for the treatment of CNS metastases in BRAF or MEK-mutated~     metastatic melanoma. A total of up to N=24 subjects with melanoma metastasized to the CNS~     will be included.~      Selected subjects will be: both males and females age ≥18 years; histologically confirmed~     melanoma with BRAF or MEK mutation with CNS metastasis; archived tumor sample from the~     primary, recurrent or metastatic disease with documented BRAF or MEK mutation; recovered from~     all acute toxicities (≥ Grade 1) due to prior therapy; determined to have adequate renal and~     hepatic function, and no known history of significant cardiac disease.~   "
17905|NCT03332576|"~     As a follow-on study to NCT01416038, this study is designed to identify the optimal dosage of~     immunotherapeutic survivin vaccine DPX-Survivac and low dose oral cyclophosphamide. The~     combination treatment is being evaluated in a non-randomized, multi-cohort study as~     post-chemotherapy treatment for patients with late-stage ovarian, fallopian tube, or~     peritoneal cancer.~   "
17923|NCT03332342|"~     The purpose of this prospective study is to evaluate different inflammatory cells that~     accumulate on the ocular surface, during sleep, and how these cells may contribute to dry eye~     disease. This study will involve at-home self-collection of tears using an eye wash method~     with sterile saline solution. While a diagnostic technique, the eye wash may also have a~     therapeutic benefit in dry eye sufferers, which will be assessed in the second phase of this~     project.~   "
17924|NCT03332329|"~     The aim of the prospective study is to determine whether combination/ sequential therapy with~     Entecavir, Peginterferon alfa-2b and immunomodulators Granulocyte Macrophage Colony~     Stimulating Factor (GMCSF)+vaccine could induce HBsAg loss in chronic hepatitis B patients~     with maintained Hepatitis B Virus (HBV) DNA suppression on long-term nucleoside or nucleotide~     analogue (NA).~   "
17925|NCT03332316|"~     Effect of perineural dexamethasone on the duration of popliteal nerve block after ankle/foot~     surgery~   "
17926|NCT03332303|"~     The objectives of this study are to evaluate the therapeutic equivalence of the Test~     formulation, Estradiol Vaginal Cream 0.01% (Prasco, LLC) to the marketed product, Estrace®~     Cream (estradiol vaginal cream, 0.01%) in patients with vulvar and vaginal atrophy, and~     compare the safety of Test, Reference and Placebo treatments in patients with vulvar and~     vaginal atrophy.~   "
17906|NCT03332563|"~     Approximately 5-8% of children report severe chronic pain and disability. Although evidence~     supports pain-self management as effective for reducing pain and disability, data show that~     most youth do not have access to this intervention. The investigative team's prior studies~     demonstrate that technology-delivered pain self-management (WebMAP program) can reduce~     barriers to care, is feasible, acceptable, and effective in reducing pain-related disability~     and improving anxiety and depression in youth with chronic pain. In this trial, the~     investigators propose an implementation project to address critical challenges in nationwide~     dissemination of the WebMAP pain self-management program. Using a hybrid~     effectiveness-implementation trial design, 8 clinics from across the U.S. will participate in~     a pragmatic randomized controlled trial with a stepped wedge design to sequentially implement~     WebMAP in the clinics following randomized usual care periods. Data will be collected from~     clinic records, web and app administrative tracking, and provider surveys to gather~     information on adoption and implementation following the Reach, Effectiveness, Adoption,~     Implementation, Maintenance (RE-AIM) public health impact framework. Individual patient-level~     pain outcomes will be collected from 140 patients to evaluate intervention effectiveness. The~     expected outcome of the project is to yield a strategic approach for a nationwide~     technology-delivered pain self-management intervention for youth with chronic pain that can~     be readily sustained in clinical settings.~   "
17907|NCT03332550|"~     The aim of this study is to evaluate clinical results and effect on health and well-being in~     patients operated for perforated diverticulitis with purulent peritonitis by laparoscopic~     lavage in Sweden when used outside of prospective studies/trials and in comparison with the~     traditional treatment, i.e. colon resection with or without stoma formation.~      A secondary aim is to evaluate the outcome after fecal peritonitis.~      The hypothesis is that laparoscopic lavage as treatment for perforated diverticulitis with~     purulent peritonitis is safe, efficient and cost saving, when used in routine health care.~   "
17908|NCT03332537|"~     This pilot project will provide foundational information about the contextual factors of~     irritable bowel syndrome (IBS) related pain (pain catastrophizing, perceived stress,~     reactivity pain sensitivity, genetic and microbiome) on pain self-management (SM) process and~     outcomes. In addition, the investigators will gain insight on the potential impact of the~     personalized IBS-pain SM approach on pain SM behaviors and health outcomes.~   "
17909|NCT03332524|"~     A phase II multicenter, double-blinded clinical trial of the safety and efficacy of~      SP160412 in the temporary relief of mild to moderate, (i.e. first degree) sunburn~   "
17910|NCT03332511|"~     ENESTKorea is a phase 4, multi-institutional, single-arm, open-label study investigating the~     efficacy and safety of nilotinib at the currently approved dose (300 mg twice daily) and its~     exposure-outcome relationship, in adult patients diagnosed as Philadelphia~     chromosome-positive chronic myeloid leukemia in chronic phase.~   "
17911|NCT03332498|"~     The purpose of this study is to determine the safety and tolerability, describe the~     dose-limiting toxicities (DLTs), and determine the maximum tolerated dose (MTD) (or the~     highest protocol-defined dose level in the absence of establishing an MTD) of ibrutinib in~     combination with pembrolizumab in participants with advanced, refractory colorectal cancers.~   "
17912|NCT03332485|"~     The purpose of this study is to evaluate the efficacy and safety of ECP (PEG 3350) Colon Prep~     Kit compared with MoviPrep split-dose as a colon-cleansing preparation for colonoscopy.~   "
17913|NCT03332472|"~     To assess the effect of a 6-month telemedicine program (DiabeTIC) in patients with type 1~     diabetes mellitus (DM1) and regular metabolic control (HbA1c <8%) in multi-dose insulin~     treatment (MDI) measured HbA1c vs. conventional medical care.~   "
17914|NCT03332459|"~     The purpose of this long-term follow-up (LTFU) study is to evaluate the incidence of the~     clinical diagnosis of asthma and the frequency of wheezing in infants and children with~     respiratory syncytial virus (RSV) infection who were treated with (lumicitabine or placebo)~     and have completed their last planned study‑related visit in a feeding Phase 2 study~     (64041575RSV2004).~   "
17915|NCT03332446|"~     The aim of this study is to investigate if regular cold water immersion after strength~     training has a negative influence on the desired training-induced performance enhancement.~   "
17916|NCT03332433|"~     Hypoxia is the most common adverse events during sedated gastroscopy. In present study,~     high-flow nasal cannula oxygenation will be utilized in order to reduce the hypoxia. At the~     same time the feasibility and safety will be evaluated.~   "
17917|NCT03332420|"~     This is a multisite, open-label, prospective and registered study designed to evaluate the~     efficacy and safety of Huai-Qi-Huang granule in children with primary nephrotic syndrome.~   "
17918|NCT03332407|"~     Sleep is important in maintaining the physiological function of the human body. Recently~     several studies have reported that preoperative sleep quality is associated with~     postoperative emergence delirium (ED) The ED is a common in pediatric patients undergoing~     general anesthesia with sevoflurane, but studies on the association of sleep quality have~     been rare. The investigators, therefore, aimed to investigate the relationship between~     postoperative delirium and pre and postoperative sleep quality in pediatric patients~     receiving strabismus surgery through this study~   "
17919|NCT03332394|"~     This study is the first to evaluate a unique integrated care model for COPD which uses a~     validated clinical frailty indicator to set care goals and guide health care in hospital and~     in the community. The impact of this care model on patient reported outcomes, costs, and~     health care utilization will inform further health system re-design for patients with COPD~     and other chronic diseases.~   "
17920|NCT03332381|"~     The design of the study is a randomized controlled trial. A total of 80 students with~     self-reported symptoms of stress/anxiety/depression will be invited to take part in a~     3-session course consisting of either attention training or self-compassion/mindfulness based~     meditation. Attention training involves modifying metacognitive control and enhancing~     attention flexibility so that people can refrain from responding to intrusions with extended~     processing. Self-compassion involves not avoiding painful or distressing feelings. Instead~     these experiences are held in awareness with kindness, understanding, and a sense of shared~     humanity.~   "
17921|NCT03332368|"~     Breast cancer is one of the most serious threat to women's health of malignant tumors, also~     the most common causes of cancer death in women.Triple-negative breast cancer (TNBC) refers~     to the immunohistochemical detection of estrogen receptor (ER), progesterone receptor (PR),~     human epidermal growth factor receptor-2 (Her-2) are negative.Compared with other types of~     breast cancer, TNBC has a high degree of invasion,local recurrence and metastasis. Also,TNBC~     can not use endocrine therapy and lack of molecular targeting for Her-2 target~     therapy.Meanwhile other biological agents are too expensive,so the current clinical therapy~     only can use in China is chemotherapy,the average survival time is about 2 years.~      Fortunately,due to the impact of traditional Chinese medicine(TCM) in China, the majority of~     breast cancer patients have received varying degrees of TCM treatment, and because of TNBC~     patients can not be more mature endocrine therapy and anti-molecular targeted therapy~     Benefits, Chinese medicine play an important role in TNBC patients.TCM regulate immune~     function, inhibit tumor growth, Anti-recurrence and metastasis, to extend the survival of~     patients with tumor, and relative to chemotherapy drugs and molecular targeted drugs,improve~     the quality of life.In addition ,comparing with the biological agents,Chinese medicine prices~     are relatively low,and can be worth using widely.~      With the development of evidence-based medicine, and gradually recognize the importance of~     comprehensive treatment of breast cancer, Cancer Treatment Model has been proposed,.That is,~     to take Chinese medicine, surgery, radiotherapy and chemotherapy, endocrine therapy and~     biological immunization and other standardized, individualized comprehensive treatment. The~     introduction of evidence-based medicine into the field of research, will be beneficial to the~     objective evaluation of TCM syndrome differentiation in the treatment of refractory breast~     cancer in the characteristics and advantages in order to promote the use of.~      This study based on TCM syndrome differentiation and treatment, and adopts multi-center,~     randomized, double-blind and controlled research methods to evaluate whether the intervention~     of traditional Chinese medicine can improve the TNBC patients with disease-free survival~     (DFS), overall survival(OS),and the best time to intervene in traditional Chinese medicine;~     also the establishment of the exact effect, obvious advantages and evidence, can be promoted~     in line with clinical practice of the program, the formation of refractory breast Cancer and~     Western medicine combined with clinical path, and relying on the national clinical research~     base of Chinese medicine information platform, the construction of clinical information~     management cloud platform, the formation of active medical service process, the establishment~     of refractory breast cancer combined with clinical prevention and treatment center, improve~     the life quality level of TNBC patients.~      The study contains 5 locations,including Longhua Hospital, Shuguang Hospital,Yueyang~     Hospital,Zhejiang Traditional Chinese Medicine Hospital and Fudan University Cancer~     Hospital.Considering of the results of the study at MD Anderson Cancer Center in foreign~     countries showed that the 3-year survival rate of TNBC patients was significantly shorter~     than that of non-TNBC patients (74% vs.89%, P <0.01) To be at least 10% survival rate.At the~     same time, considering the case lost rate of 20%, calculated by PASS software, the number of~     samples for each group of 310 cases, a total of 620 cases of cohort study. According to~     whether to take traditional Chinese medicine,all the participants are divided into exposure~     group and non-exposure group, the number of observations per group is 310.~      Before the research, all participants needs to fill in the informed consent form,~     investigators introduce the clinical research related matters to them and record the basic~     situation. The Chinese medicine exposure group take Chinese medicine(San Yin Decoction )~     besides of original Western medicine , non-exposed group only received Western medicine~     treatment, a total of two years.All results are recorded in the CRF table,and use SPSS18.0,~     Stata10.0 and other statistical software for data to analysis.~   "
17977|NCT03331627|"~     a multicenter, double-blind, placebo-controlled study in patients with Sudden Sensorineural~     Hearing Loss (SSHL). Patients will be treated with STR001 thermogel (STR001-IT) / STR001~     tablets (STR001-ER) and corresponding Placebo on top of standard of care.~   "
17928|NCT03332277|"~     Adult degenerative (de novo) scoliosis (ADS) is a condition of the ageing population caused~     by degenerative changes without pre-existing spinal deformity. Pain is the most frequent~     problem, especially low back pain and radicular pain, and seriously affects the daily~     activities and health of ADS patients. The current treatment for ADS is not well defined. The~     main intervention for ADS treatment is surgical, but surgery is clearly not appropriate for~     every patient. Active bodysuits will be designed based on body alignment and pain management~     using special design components and incorporating active posture training from a biofeedback~     system. Back pain is often localized along the convexity of the curve, and passive support to~     the areas of pain, most likely in the lower trunk, hip and lower extremities, should be~     provided.~   "
17929|NCT03332264|"~     Patients with peripheral artery disease will be treated with either drug coated balloon~     catheter, drug coated stent or uncoated stent.~   "
17930|NCT03332251|"~     Adolescent idiopathic scoliosis (AIS) is a prevalent chronic condition that gradually leads~     to the three dimensional deformity of the spine. Spine curvature increases in youths as~     puberty progresses. Generally, only observation is suggested for adolescents with early~     scoliosis (Cobb's angle ≤ 20°). Rigid brace treatment is too draconian for them due to the~     high corrective force which nearly constrains all movements. Flexible brace treatment is an~     alternative option; however, its efficacy is still controversial. Posture correction girdle~     with a specialized design for teenagers with scoliosis is limited and most part of them can~     only provide some improvement for bad postures, such as hunchback. A scientific approach~     should be used to design and develop posture correction girdle as a treatment option for~     adolescents with early scoliosis.~   "
17931|NCT03332238|"~     Rotator cuff disease is one of the most prevalent musculoskeletal conditions across the~     world. Patients with chronic rotator cuff tears often have substantial muscle atrophy and~     fatty infiltration. Surgical repair of the tear does not reverse the atrophy, and many~     patients continue to experience weakness, pain, and a persistent reduction in the quality of~     life. An important limitation in our ability to successfully rehabilitate these injuries~     postoperatively and return patients to normal function has to do with the poor quality of the~     muscle and tendon after rotator cuff repair. The stromal vascular fraction (SVF) of~     subcutaneous adipose tissue is highly enriched with cells (SVFCs) that can both directly~     participate in tissue regeneration by differentiating into myogenic and tenogenic cells, and~     indirectly by secreting growth factors and small molecules which activate pathways associated~     with healthy tissue regeneration. High numbers of autologous SVFCs can be isolated using the~     cost-effective, intraoperative Icellator (Tissue Genesis, Honolulu, HI) point-of-care system.~     This clinical trial will be determine if the use of SVFCs can enhance outcomes for patients~     who are undergoing surgical repair of a torn rotator cuff.~   "
17932|NCT03332225|"~     The aim of the study is to conduct one RCT of personalized immunotherapy in sepsis targeting~     patients who lie either on the predominantly hyper-inflammatory arm or on the predominantly~     hypo-inflammatory arm of the spectrum of the host response. These patients will be selected~     by the use of a panel of biomarkers and laboratory findings and they will be randomly~     allocated to placebo or immunotherapy treatment according to their needs.~   "
17933|NCT03332212|"~     The objective of this trial is to assess the effect of empagliflozin on cardiac physiology~     and metabolism aiming to provide a scientific explanation of the underlying mechanism by~     which empagliflozin improves HF related outcomes in patients with chronic heart failure~   "
17934|NCT03332199|"~     The purpose of this study is to develop, implement and undertake a preliminary evaluation of~     a psychoeducational intervention for managing a cancer-related symptom cluster including~     pain, fatigue and sleep disturbance experienced by Vietnamese cancer patients.~   "
17935|NCT03332186|"~     The purpose of this study is to investigate experimental medication BMS-986231 in patients~     with different levels of kidney function.~   "
17936|NCT03332173|"~     Screening (up to 28 days); daily treatment until disease progression, unacceptable toxicity~     or death, withdrawal of consent, lost to follow-up, or study termination from sponsor;~     treatment (up to 3 years), safety follow up (28 days); survival follow-up until data cutoff~     for final analysis.~   "
17937|NCT03332160|"~     The study will evaluate the feasibility, and preliminary effectiveness of the Flexitouch head~     and neck treatment plus standard home care compared to standard home care regimen alone.~   "
17938|NCT03332134|"~     The goal of this study is to test and evaluate the feasibility, acceptance, safety, and~     efficacy of an an intimate partner violence (IPV) intervention in recently-married,~     low-income husband-wife dyads in Pune, India.~   "
17939|NCT03332121|"~     It's the first-in-human study of Recombinant Humanized Anti-CD20 Monoclonal Antibody for~     Injection (B001). The main purpose of this study is to explore the safety and tolerance of~     B001 for patients with CD20 positive B-cell non Hodgkin's lymphoma. It will also explore the~     PK/PD manner and ORR in this study.~   "
17940|NCT03332108|"~     This is a randomized trial of use of a mobile health tool (EpxBreastfeeding) aimed at~     improving breastfeeding adherence and duration among recent mothers who self identify as~     motivated to breastfeed. As a result of text communication and expedited coaching through~     common breastfeeding challenges, the investigators expect more mothers in the study arm will~     continue breastfeeding through the first 6 months after giving birth.~   "
17941|NCT03332095|"~     The purpose of this study is to evaluate the pharmacokinetics, safety, and tolerability of~     doravirine (also called MK-1439 or DOR) and doravirine/lamivudine/tenofovir disoproxil~     fumarate (also called MK-1439A or DOR/3TC/TDF) in HIV-1-infected children and adolescents.~   "
17942|NCT03332082|"~     Orthodontic relapse occurs in almost 80% of Orthodontic Treatment. The only prevention to~     phenomenon is the use of fixed retainers or life time active retention. Unfortunately,~     patients do not comply and after a year of treatment, many stop wearing their retainers and~     Orthodontic relapse occurs.~      The aim of this project is to prospectively analyze the treatment result of consecutive~     treated patients who have had active orthodontic relapse. 20 patients will be recruited~     through advertisement to the Department of Orthodontics at the University of Alabama at~     Birmingham (UAB). The sample will comprise of 20 patients with Class I malocclusions. The~     records to be collected will comprise of clinical pictures and pre and post study casts. The~     3D study casts will be evaluated using the Little's Index. The results will be analyzed with~     the paired t-test and ANOVA, using the Statistical Analysis System (SAS/STAT®) software.~   "
17943|NCT03332069|"~     This is a phase III randomised clinical trial. The aim is to investigate the clinical effects~     of the addition of modulated electro-hyperthermia (mEHT) to standard treatment protocols~     (chemoradiotherapy, CRT) for Human Immunodeficiency Virus (HIV) positive and negative locally~     advanced cervical cancer patients (LACC). SAMPLE: The investigators aim to enrol 236 HIV~     negative and HIV positive women with LACC, FIGO (Fédération Internationale de Gynécologie et~     d'Obstétrique) Stages IIB (distil) to stage III. Participants will be randomly assigned to a~     control group (N=118) and a study group (N=118). METHODOLOGY: Randomisation is based on age,~     stage and HIV. Participants from both groups will receive the standard treatment for cervical~     cancer at the hospital at the Charlotte Maxeke Johannesburg Academic Hospital in South~     Africa: Up to three doses of 80mg/m2 cisplatin, administered three weeks apart; 50Gy external~     beam radiation (EBR) in fractions of 2Gy; Three doses of 8Gy High Dose Rate (HDR)~     brachytherapy. The study group will have two 55 minute mEHT treatments per week, at 130W,~     directly before the EBR using the EHY 2000 Device. OUTCOMES: 1) Determine the local disease~     control after treatment at 6 months using a Positron Emission Tomography (PET) and~     computerised tomography (CT) scans. 2) Determine the progression-free survival (PFS) at 6,~     12, 18 and 24 months after the last treatment date. PFS will be assessed in all registered~     participants, regardless of completion (Intent to Treat-ITT) as well as only in the subset of~     participants who complete the prescribed CRT. 3) Overall survival at two years will be~     assessed. 4) To evaluate the adverse events associated with mEHT. 5) The effect of mEHT on~     chemotherapy and radiotherapy tolerability and toxicity will be evaluated. 6) The quality of~     life of enrolled participants will be assessed before, at 6 weeks, and at 3, 6, 9, 12, 18 and~     24 months after completion of therapy using the EORTC (European Organisation for Research and~     Treatment of Cancer) and EuroQoL forms. 7) To evaluate the economic viability of the addition~     of mEHT to standard treatment protocols for LACC. 8) The effect, if any, of mEHT treatments~     on the HIV disease status of HIV positive patients will be assessed by the presence of~     Autoimmune Deficiency Syndrome (AIDS) defining illnesses before and after treatment. 9) The~     cancer recurrence patterns will be described and compared in all the participants.~   "
17944|NCT03332056|"~     The purpose of this study is to determine if preemptive B&O suppository placement will~     decrease post-operative pain in patients undergoing ureteral stent placement.~   "
17945|NCT03332043|"~     This randomized, controlled clinical pilot trial will evaluate the effects associated with~     in-office use of closed-loop, acoustic stimulation neurotechnology (High-resolution,~     relational, resonance-based, electroencephalic mirroring; HIRREM), compared with acoustic~     stimulation not linked to brainwaves (ambient nature sounds), for participants with~     pre-hypertension. Data collection will occur at baseline, and at intervals after completion~     of the intervention. Outcomes include blood pressure, measures of autonomic cardiovascular~     regulation, behavioral symptom outcomes, quality of life, alcohol use, and functional~     performance measures. The primary outcome will be change in blood pressure from baseline to~     4-6 weeks after intervention.~   "
17946|NCT03332030|"~     Objectives 1. Establish an induced pluripotent stem cell (iPSC) bank for phenotypically~     well-characterized patients with NF1.~      2. Develop isogenic NF1 wild-type (NF1+/+), NF1 heterozygous (NF1+/-) and NF1 homozygous~     (NF1-/-) iPSC lines from individual patients using CRISPR/CAS9 technology.~      3. Differentiate and characterize disease-relevant brain cells such as excitatory and~     inhibitory neurons, astrocytes and oligodendrocytes from patient-specific iPSC lines.~      4. Screen and identify the drug(s) that can reverse or alleviate the disease phenotypes.~   "
17947|NCT03332017|"~     The purpose of the study is to evaluate the efficacy, safety and tolerability and of~     BGB-3111plus obinutuzumab versus obinutuzumab alone in subjects with relapsed/refractory~     non-Hodgkin follicular lymphoma.~   "
17948|NCT03332004|"~     The aim of the study is to establish a new and more accurate method to visualize the~     peritoneal changes caused by endometriosis using Indocyanine Green mediated fluorescence~     imaging. The hypothesis is that Indocyanine Green, a fluorescent dye that has wide~     applications throughout medicine in identifying vascularity of tissues and~     neovascularization, could facilitate the localization and excision of endometriotic lesions~     exploiting the hypervascularization due to the chronic inflammation~   "
17949|NCT03331991|"~     The purpose of the study on the Prevention of Influenza and Other Wintertime Respiratory~     Viruses among Healthcare Professionals in Israel Effectiveness of Influenza Vaccine in~     Preventing Influenza Virus Infection, Missed Work, and Patient Exposure: A Prospective Cohort~     Study of Healthcare Personnel (to be called the Healthcare Personnel or HCP study throughout~     this Data Security Plan) is to investigate vaccine effectiveness and respiratory illness~     among healthcare personnel (HCP). This will help to better understand the factors that~     influence influenza vaccination choice, individual vaccine response, and whether or not the~     influenza vaccine helps to prevent influenza in HCP.~   "
17950|NCT03331978|"~     Project Rise is a randomized controlled trial (RCT) of an innovative, culturally congruent~     treatment education (TE) intervention for African Americans with HIV that targets cultural~     and social issues contributing to health disparities.~   "
17951|NCT03331965|"~     The goal of this study is to determine whether use of promotility agents to stimulate gastric~     peristalsis can reduce fluoroscopy time and procedure time during gastrojejunostomy (GJ)~     tubes placement in interventional radiology (IR). The investigators hypothesize that~     increased gastric peristalsis will aid in advancing a guidewire through the pylorus, a time~     consuming and tedious step required during GJ tube placement. In order to maximize scientific~     rigor and clinical practice impact, the investigators aim to answer this question through a~     blinded, randomized, placebo controlled trial.~      Specific Aim 1: To test the hypothesis that a single dose of IV metoclopramide immediately~     prior to GJ tube placement reduces the fluoroscopy time required to advance a guidewire~     through the pylorus.~      Specific Aim 2: To determine whether a single dose of IV metoclopramide immediately prior to~     GJ tube placement reduces total procedure fluoroscopy time, air kerma and total procedure~     time.~      Specific Aim 3: To assess the safety of a single dose of promotility agent prior to GJ tube~     placement by assessing rates of adverse events in the periprocedural period in patients~     receiving IV metoclopramide versus placebo.~   "
17978|NCT03331614|"~     This is a controlled trial to evaluate the efficacy of an Sequential Contraction Compression~     Device (SCCD) on the symptomatology of Painful Diabetic Neuropathy. Subjects will be divided~     into a control group where they will be monitored while continuing with their current~     treatment regimen and into a treatment group where they will continue with their current~     regimen and have SCCD therapy added. Subjects will be evaluated for Subjective Pain levels,~     quality of life, breakthrough drug use, sleep levels, and objectively with a Quantitative~     Sensory Testing device. The trial duration is 30 days.~   "
17979|NCT03331601|"~     This study investigates the uptake of the radiopharmaceutical 68-GaNOTA-Anti-HER2 VHH1 in~     brain metastasis using PET/CT imaging. Patients with HER2-positive and HER2-negative breast~     cancer will be included and the uptake in their lesions will be compared.~   "
25369|NCT03234907|"~     The purpose of this study is to assess the safety and efficacy of vedolizumab intravenous~     (IV) infusion as induction treatment in Chinese participants withmoderately to severely~     active Crohn's disease (CD) at Week 10.~   "
17952|NCT03331952|"~     Streptococcus pneumoniae (the pneumococcus) remains a leading cause of childhood mortality~     and morbidity. Between 2007 and 2012, Angkor Hospital for Children (AHC), Siem Reap, Cambodia~     documented that S. pneumoniae was responsible for around 10% of bloodstream infections in~     hospitalised children, with a case fatality rate of 15.6%.~      The use of pneumococcal conjugate vaccines (PCV), covering between 7 and 13 of the >90~     pneumococcal serotypes, has resulted in significant declines in invasive pneumococcal disease~     (IPD) incidence in countries where they are included in routine childhood immunisation~     schedules. Paediatric radiologic pneumonia incidence is also reduced by PCV, but the impact~     on clinical pneumonia is minimal. The vaccines have had an effect on reducing the burden of~     drug resistant IPD, although this may not be sustained. Given the large number of serotypes~     not included in the current PCV formulations, it is not surprising that initial declines in~     overall IPD incidence have been eroded by, for the time being, small increases in IPD due to~     non-vaccine serotypes. To date most data on this serotype replacement disease has come from~     high-income countries. It less clear how much serotype replacement will occur in low and~     middle income countries, where pre-PCV disease incidence is generally higher and other~     factors, such as unregulated antimicrobial consumption, may play a role in encouraging~     non-vaccine serotype infections.~      Nasopharyngeal colonisation by S. pneumoniae is common in childhood and is an essential~     prerequisite for invasive disease. Surveillance of pneumococcal colonisation can provide~     important data regarding serotype replacement and disease-associated serotypes, and may also~     allow prediction of likely IPD incidence changes post-vaccine introduction. A recent study of~     pneumococcal colonisation in children attending the AHC out-patients has documented an~     overall colonisation prevalence of approximately 65%.~      In January 2015, Cambodia will introduce the 13-valent PCV (PCV13; serotypes covered 1, 3, 4,~     5, 6A, 6B, 7F, 9V, 14, 18C, 19F, 19A, 23F). The vaccine will be rolled out nationally with a~     3+0 dosing schedule (6, 10 and 14 weeks) and no catch up campaign. There is no robust~     national surveillance system in place to monitor the effects of PCV13 introduction.~   "
17953|NCT03331939|"~     The purpose of this investigation is data pilot study of the effect of theta frequency~     stimulation of the vagus nerve on cognitive performance in patients with refractory epilepsy.~     We will compare the effects of no stimulation, theta frequency (5 Hz), and 'standard' beta~     frequency stimulation (25-30 Hz) on cognitive measures. We hypothesize that theta frequency~     VNS will have a positive effect on memory retention. The goal of this study to provide~     initial data to inform the design of a larger clinical trial to examine the efficacy of theta~     VNS.~   "
17954|NCT03331926|"~     To evaluate the effect of collagenase clostridium histolyticum treatment at the Department of~     Orthopaedic surgery at Horsens Regional Hospital after minimum one-year follow-up (FU).~   "
17955|NCT03331913|"~     Trigeminal neuralgia (TN) is one of the most painful and common types of neuropathic pain~     encountered by clinicians. It is typically treated pharmacologically with anticonvulsants,but~     these can be ineffective, or can lose their effectiveness over time.Botulinum toxin type A~     (BoNT-A) is an exotoxin released by the Gram-positive, anaerobic bacillus Clostridium~     botulinum that causes flaccid paralysis by blocking neurotransmitter release by axonal~     terminals. As a contaminant, it is the cause of potentially lethal botulism poisoning;~     however, as a drug, it has been widely used in the treatment of dystonia, as well as for~     non-surgical cosmetic treatment. More recently, studies investigating the ability of BoNT-A~     to treat pain have been increasing. In 2012, the investigators reported the results of a~     randomized, double-blind, and placebo-controlled trial in which subcutaneous injection of~     BoNT-A at the site of pain provided long-term effective relief in TN. The investigators noted~     that adverse effects were mild, as well. Other studies on TN have estimated the effectiveness~     of BoNT-A treatment in TN to be 47-73%. However, BoNT-A treatment is still ineffective in~     more than 30% of patients.In this study, the investigators investigate whether different~     treatment methods have different efficacy and safety.~   "
17956|NCT03331900|"~     The study is a randomized, double-blind, placebo-controlled, dose escalation, first-in-human~     trial of the safety and tolerability of COR388 HCl in healthy male and female subjects.~   "
17957|NCT03331887|"~     Different types of post and core have been used for several years for restoring anterior~     endodontically treated teeth, but their preparations involve various risks such as: root~     perforation, root weakness and tooth fracture. The introduction of adhesive systems and~     conservative restorations, make it possible to reconstruct damaged anterior endodontically~     treated teeth with conservative restoration as endocrowns. The hypothesis of this trial is~     that E-max CAD endocrowns will show comparably equal clinical performance if compared to~     E-max CAD crowns retained with fiber reinforced composite post and core system when treating~     anterior endodontically treated teeth..~   "
17958|NCT03331874|"~     Basal cell carcinoma (BCC) is the commonest non melanoma skin cancer in the UK and its~     incidence is rising. The Norfolk and Norwich University Hospital Foundation Trust (NNUHFT)~     see and excise approximately 3,000 new cases of BCC each year. Many of these patients have a~     biopsy to confirm their diagnosis before being listed for surgical excision. In vivo~     reflectance confocal microscopy (RCM) involves using a machine which can examine the upper~     layers of the skin non invasively.~      In clinically suspicious lesions, the Investigators will use RCM prior to biopsy with the aim~     of demonstrating that RCM can accurately diagnose BCC. The aim of this study is to determine~     the feasibility and utility of using RCM for the diagnosis of BCC in the NHS setting, thereby~     shortening the patient pathway and effectively using limited public resources. If the~     Investigators' study shows that RCM can accurately diagnose BCC in these patients then this~     would prevent the need for biopsy as a routine in these patients.~   "
17959|NCT03331861|"~     Columbia University Medical Center is conducting a pilot clinical research study that will~     assess the use of the medication metformin for heart failure in patients who are not~     diabetic.~      Patients will received either the study drug metformin or placebo for 4 months. During the~     study, the patients will undergo extensive testing that will include symptom assesment,~     exercise capacity, echocardiography and blood tests.~   "
17960|NCT03331848|"~     This is a Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-arm Phase IIa~     proof of concept in subjects with PD treated with a stable dose of levodopa who are~     experiencing Motor Complications of Levodopa Therapy~   "
17961|NCT03331835|"~     The primary objective is to demonstrate added benefit of brodalumab versus a selected~     systemic comparator in treatment of moderate to severe plaque psoriasis in Germany in~     subjects who have not previously received systemic treatment for psoriasis.~      Fumaric acid esters have been selected as the comparator because it is an established~     systemic treatment of psoriasis in Germany.~   "
18004|NCT03331276|"~     A goal of infant formula development is to mimic human milk (HM) both in nutrient composition~     as well as physiologic outcomes. investigators have developed an infant formula for term~     infants that more closely resembles the composition of human milk. The purpose of this study~     is to demonstrate that this formulation meets nutritional requirements and supports age~     appropriate growth of healthy term infants.~   "
17962|NCT03331822|"~     In the majority of intensive care units, nurses work 12 hour shifts that consist of days and~     nights. Shift work outside of 6am-6pm has been reported to cause fatigue, induce sleep~     disorders, and cause metabolic disturbances. This shift to a nocturnal 'day' rather than~     diurnal, can result in reduced work performance, processing errors, accidents at work,~     absenteeism, and reduced quality of life. More chronically, those working at night have been~     shown to experience higher risks of heart disease, cancer and shorter median durations of~     life span. Much of this elevated risk is thought to be due to altered exposure to light, the~     dominant environmental cue regulating our circadian rhythms.~      As diurnal organisms much of our biology is regulated by the solar day. Acutely, bright light~     exposure (i.e., sun) regulates the phase of the biological clock principally through the~     suppression of melatonin, which biologically mediates increased alertness and in essence,~     'our daytime alertness'. During the night melatonin gradually increases and induces tiredness~     and ultimately sleep. This, in part, is biology behind the use of melatonin in those with~     sleep disturbances or to mitigate jet lag, with cross-continental or transoceanic flights.~      In this study, the investigators will randomize nurses in the hospital to receive either high~     intensity white light (3,000 lux) or standard ambient white fluorescent (~400 lx) light for~     10 hours during their night shift. This high illuminance light, rich in blue spectrum, is~     what diurnal creatures, like humans, are exposed to during the day. The lights may~     subsequently be equipped with blue filters (442 nm) to heighten the exposure to the rich blue~     spectrum light. Exposure will commence at the beginning of the night shift (~7pm) and~     continue for 10 hours. The rationale for terminating exposure prior to shift end is to foster~     an onset of sleep biology. At the end of each shift, the nurses will complete the Stanford~     Sleepiness Scale and the Psychomotor Vigilance Task (PVT). Saliva samples will be collected~     for melatonin level analysis and the nurses will complete sleep diaries at home. The~     investigators hypothesize that exposure to high intensity lighting during night shifts will~     reduce fatigue and enhance alertness and computational capacity that correlates with reduced~     melatonin.~   "
17963|NCT03331809|"~     This investigation is planned to compare the incidence and severity of postoperative sore~     throat according to the use of two-handed jaw thrust maneuver in patients undergoing~     double-lumen endotracheal intubation.~   "
17964|NCT03331796|"~     The goal of this study is to test the efficacy of repetitive Transcranial Magnetic~     Stimulation (rTMS) as a treatment for Mild Cognitive Impairment (MCI). Participants will be~     randomly assigned to one of three treatment groups: Group 1: Active Dorsolateral Prefrontal~     Cortex (DLPFC) rTMS; Group 2: Active Lateral Parietal Cortex (LPC) rTMS; and Group 3:~     Inactive rTMS (Placebo) control (evenly split between each coil location). Participation in~     the study takes approximately 7 ½ months—including a 2-to 4-week treatment phase (20 rTMS~     sessions) and a 6-month follow-up phase.~   "
17965|NCT03331783|"~     The study investigates the impact real output has on adhesion of new adhesives~   "
17966|NCT03331770|"~     This study evaluates the efficacy and tolerability of a new formulation of latanoprost~     without Benzalkonium Chloride (BAK-free). Patients with open-angle glaucoma who were using~     BAK-containing latanoprost ophthalmic solution for ≥6 months, switched to BAK-free~     latanoprost ophthalmic emulsion.~   "
17967|NCT03331757|"~     This study determined the glycemic index and glycemic load of six Greek honey varieties~   "
17968|NCT03331744|"~     The primary purpose of this study is to identify the clinical characteristics of infantile~     hemangioma (IH) in our single center in China. The second objective of the study is to~     identify the clinical features of infantile hepatic hemangioma (IHH) and ulceration in~     patients with IHs.~   "
17969|NCT03331731|"~     The purpose of this study is to test how safe and effective the research study drug,~     pembrolizumab is as a treatment for patients with Hodgkin lymphoma who have not previously~     been treated for this disease and are unsuitable for standard treatment (adriamycin,~     bleomycin, vinblastine, dacarbazine ABVD).~   "
17970|NCT03331718|"~     The polyglycolic acid (PGA) mesh is a felt-like absorbable suture reinforcing material. The~     pancreatojejunostomy aimed at reducing POPF is not established at present. We devised a new~     method using doubly PGA mesh. This study is a multicenter, randomized phase III trial between~     Japan and Korea to verify the usefulness of this double coating of PGA mesh.~   "
17971|NCT03331705|"~     This is a prospective, multicenter, single-arm, open-label clinical usability study in~     subjects who are candidates for office diagnostic cystoscopy. The primary objective of this~     initial device assessment is to evaluate the performance of a new cystoscope for direct~     visualization of the urethra and bladder.~   "
17972|NCT03331692|"~     Clinical monitoring is the most common method of adjustment of the appropriate level of~     general anesthesia. However, the episodes of intraoperative awareness are still reported,~     suggesting that clinical observations may not be sufficient in some cases. The objective of~     the study was to compare the efficacy of clinical and instrumental neuromonitoring with~     auditory evoked potentials in intraoperative analysis of the proper level of general~     anesthesia.~      The patients scheduled for elective surgery were included into the study, and randomly~     divided into two groups. Patients in the first group (TIVA group) underwent intravenous, in~     the second group (VA group) underwent volatile anesthesia. The adequacy of anesthesia was~     analyzed with standard clinical parameters. All the participants were instrumentally~     monitored with AAI index. After the anesthesia patients received a questionnaire with the~     questions regarding possible intraoperative awareness.~   "
17973|NCT03331679|"~     The incidence of conditions requiring surgical intervention increases with age, however there~     is a reported decline in the rates of elective surgical procedures in those over 65. This is~     associated with older patients being described as less fit and more at risk of~     postoperative complications, leading to decreased provision of surgical care to those at~     need. Exercise interventions have the potential to reverse some of the decline in~     cardiovascular fitness associated with aging and improve the elderly's' fitness for surgery~     and potentially allow increased access to surgical care for those most in need of it.~   "
17974|NCT03331666|"~     The primary goal is to assess the impact of Evolocumab therapy on platelet function of~     familial hypercholesterolemia (FH) patients in a randomized, double blind study. Evolocumab~     is a humanized monoclonal antibody that targets circulating PCSK9, increases hepatic LDL~     receptor, decreases plasma LDL cholesterol and reduces risk of cardiovascular events.~     Evolocumab (brand name Rapatha) has been approved by FDA along with diet and maximally~     tolerated statin therapy in adults with FH or atherosclerotic heart or blood vessel problems,~     who need additional lowering of LDL cholesterol.~      The secondary goal is to determine if platelet activation or the response to Evolocumab~     therapy is modified by rs3184504 polymorphism. The investigators believe that these~     investigations will complement ongoing studies to demonstrate that Evolocumab reduces~     athero-thrombotic risk and aid the decision-making as to whether Evolocumab can reduce the~     atherothrombotic risk in ACS patients.~   "
24127|NCT03251170|"~     The aim of this work is to compare two protocols (ketamine-midazolam versus~     fentanyl-midazolam) for induction of anesthesia in patients with septic shock aiming to find~     the most safe protocol with regards to hemodynamic status of patients~   "
17980|NCT03331588|"~     One-thirds of patients underwent video-assisted thorascopic surgery (VATS) still have severe~     pain.Uniportal lobectomy or segmentectomies emerged as a promising and exciting approach for~     minimally invasive thoracic surgery. However, nearly all reported uniportal VATS lobectomies~     have been performed via the intercostal route, and chest wall trauma has still occurred.~     Here,the investigators undertook novel uniportal VATS technique involving a subxiphoid route~     for pulmonary lobectomies or segmentectomies.We would like to evaluate the post-operative~     pain and quality of life between Subxiphoid and Intercostal VATS for Lung Cancer.~   "
17981|NCT03331575|"~     This protocol is a phase III randomized controlled trial (RCT) evaluating the efficacy of~     hypofractionated vs. conventionally fractionated concurrent chemo-radiotherapy for~     unresectable stage III non-small-cell lung cancer~   "
17982|NCT03331562|"~     Chemotherapy regimens for pancreatic cancer can now stabilize a patient's cancer and/or place~     some patients in remission or partial remission. The challenge now is to find options for~     maintenance therapies that will improve survival and allow continued benefits with minimal~     toxicities and inconvenience to the patients. This study will determine the effects of one~     possible maintenance regimen.~      The study is being conducted to determine the effects that pembrolizumab with or without the~     addition of paricalcitol may have on pancreatic cancer. Half of the patients will be~     randomized to receive pembrolizumab + paricalcitol and half to receive pembrolizumab +~     placebo.~   "
17983|NCT03331549|"~     The purpose of the study is to establish a high-sensitivity troponin 0h/1h process for the~     diagnosis of patients suspected of NSTEMI for the Chinese population, obtain the inclusion~     and exclusion criteria for diagnosis of these patients and compare the new process with the~     existing diagnosing methods and processes, including the 3h and 6h processes more extensively~     used at present and the ECG combined with troponin diagnosis, so as to explore a confirmation~     model suitable for the Chinese population.~   "
17984|NCT03331536|"~     The investigators propose a prospective cohort trial that will help to understand the impact~     of Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) in pre- and post-menopausal~     female bariatric patients.~   "
17985|NCT03331523|"~     This is a phase III, randomized, double-blind, placebo-controlled, parallel- group,~     multiple-site study to evaluate the therapeutic equivalence of generic calcipotriene and~     betamethasone dipropionate topical suspension, 0.005%/0.064% of Glenmark Pharmaceuticals Ltd~     to that of the marketed product Taclonex® topical suspension of Leo Pharma Inc. in the~     treatment of scalp psoriasis.~   "
17986|NCT03331510|"~     Open and arthroscopic Latarjet procedures are used to treat shoulder instability as primary~     and salvage procedures. During surgery the coracoid process is detached and repositioned to~     the anterior glenoid through a subscapularis split and fixed in place, resulting in an~     enlarged glenoid and therefor articular surface. However, before this is done, the pectorals~     minor, which inserts at the coracoid process, has to be detached and is left without further~     treatment. Moreover, the conjoint tendon, the origin of the short head of the biceps and~     coracobrachialis, is repositioned with the coracoid and therefor distalized and medialized.~      No study currently followed up on the strength of the muscles altered. The aim of this study~     is therefor, to prospectively measure range of motion and strength of the operated shoulder~     at different time points pre- and postoperatively, comparing it with the healthy shoulder in~     each individual.~   "
17987|NCT03331497|"~     Children with periodic fever, aphthous stomatitis, pharyngitis, adenitis (PFAPA) -syndrome~     diagnosis will be randomised either to tonsillotomy (partial tonsillectomy) or 3 months~     follow up. At follow up visit 3 months after randomisation the children from either groups~     with ongoing symptoms will be sent to tonsillectomy.~   "
17988|NCT03331484|"~     Currently, there is a minimal data on the combination of rivaroxaban and ticagrelor in~     patients with atrial fibrillation (AF) managed with percutaneous coronary intervention (PCI).~     Furthermore, there exists significant controversy among physicians in the use of oral~     anticoagulants in conjunction with antiplatelet therapy in this population. The present~     recommendation is triple therapy (aspirin + clopidogrel + warfarin) which has been related to~     major bleeding complications. Previous studies have shown that ticagrelor has been proven to~     be more effective in reducing the rate of death, new heart attacks, or strokes than the~     previous recommendation drug, clopidogrel, and studies have shown that less bleeding occurs~     with rivaroxaban than warfarin, it would be ideal to investigate the two potent drugs,~     ticagrelor with rivaroxaban, and gain insight in the management of these high risk patients.~      The CAPITAL PCI AF study is a phase 3 Health Canada regulated interventional study involving~     the use of investigational drugs. It is a non-randomized, open design study. The~     investigational team is studying the high potent drug Ticagrelor, which is prescribed to~     participants receiving a stent placement, given with Rivaroxaban, an oral anticoagulant~     recommended for patients with atrial fibrillation (AF). The primary clinical endpoint is a~     safety outcome measuring bleeding complications in participants with atrial fibrillation~     treated within one year of the index PCI. The primary efficacy endpoint is measured by the~     clinical outcomes of death, stroke, non- central nervous system (CNS) systemic embolism,~     myocardial infarction and stent thrombosis within one year of the index PCI.~   "
17989|NCT03331471|"~     Alveolar recruitment maneuver had been reported of improving arterial oxygenation and~     pulmonary mechanics and reduce the pulmonary complications. Investigator designed this study~     for comparision of incidence of pulmonary complications after applying alveolar recruitment~     maneuver during peumoperitoenum for laparoscopic surgery.~   "
17990|NCT03331458|"~     Recent research has indicated that physical activities incorporating moderate-intensity~     exercise can be safely performed during treatment and substantially reduces treatment-related~     side effects, such as fatigue, sleep disturbances, cognitive impairment, and nausea. However,~     little is known about physical activity levels prior to treatment and whether providing an~     exercise intervention pre-treatment may improve functional capacity during treatment.~      The purpose of this study is to~        1. Measure physical activity levels and functional capacity in men newly diagnosed with~          prostate cancer prior to treatment and~        2. Explore whether a 2-week physical activity intervention is feasible during the~          pre-treatment timeframe:~             1. Examine intervention safety and tolerance by self-report~             2. Examine changes in functional capacity by 6-minute walk test~             3. Examine changes in symptom experience by self-report~   "
17991|NCT03331445|"~     Non tuberculous mycobacteria (NTM) infections in the lung are almost impossible to eradicate~     with conventional antibiotics. These patients have few options to treat their lung infection.~     It has been shown that nitric oxide was safe to be inhaled for similar cystic fibrosis~     patients and reduced drug resistant bacteria in the lungs. Further, research indicates that~     clinical isolates of NTM can be eradicated by 160ppm NO exposure in the laboratory petri~     dish. This is not the first time inhaled NO treatment has been used in patients with NTM~     (case studies). This study will provide more data to see if NO therapy can reduce the NTM~     bacterial load in the lungs and help the patients breath better.~   "
17992|NCT03331432|"~     The purpose of the present study is to determine if use of dietary supplement~     tauroursodeoxycholic acid enhances insulin-stimulated leg blood flow and glucose disposal.~   "
17993|NCT03331419|"~     This pilot study is intended to identify sex differences in myalgic encephalomyelitis/~     chronic fatigue syndrome (ME/CFS) during recovery from brief but high effort exercise tests.~     It is expected that women with ME/CFS as compared to males with ME/CFS will show slower~     recovery from exercise with respect to heart rate and blood pressure, physical functioning,~     and symptom severity. Also females with ME/CFS as compared to males with ME/CFS will show~     greater negative impacts on heart rate, blood pressure, physical functioning and symptom~     severity after the two exercise tests. The findings will have implications for sex~     differences in the pathophysiology of post-exertional malaise and activity/exercise~     self-management recommendations, given the expected detrimental effects of the brief intense~     exercise tests on patients with ME/CFS.~   "
17994|NCT03331406|"~     This research study is evaluating the ability for people with metastatic gastrointestinal~     cancer to participate in a physical activity program.~   "
17995|NCT03331393|"~     The purpose of this study is to investigate the value of Orencia in rapidly progressing~     Rheumatoid Arthritis (RA).~   "
17996|NCT03331380|"~     Background:~      Researchers are testing a new kind of magnetic resonance imaging (MRI) scanner to take~     pictures of the heart. It uses lower energy levels than other MRI scanners. This may help~     scan people with metal devices in their body, or in invasive heart procedures using metal~     tools.~      Objective:~      To test new MRI scanners and software changes to create better pictures of the heart.~      Eligibility:~      People with heart disease and healthy volunteers, ages 18 and older~      Design:~      Participants will be screened with blood tests.~      Participants with heart disease will have both the new MRI and a conventional MRI. Healthy~     participants will have both MRIs or only the new one. If 2 are done, they must be within 60~     days.~      For both MRI versions, participants lie on a table that slides into a large tube. During~     scans, they will hold their breath for up to 20 seconds at a time. Heart activity will be~     measured by wires connected to pads on the skin. A flexible belt may be used to monitor their~     breathing. They will be in the scanner up to 2 hours.~      Participants can agree to have a dye called gadolinium injected into their arm during the~     scan. This brightens the pictures of the heart.~      Participants can agree to take a drug called a vasodilator. This helps detect areas of the~     heart with abnormal blood supply. Scans of the heart are taken before, during, and after they~     get the medicine. The drug may cause temporary chest pain or shortness of breath. They may~     get other drugs to relieve these symptoms.~      Sponsoring Institution: National Heart, Lung, and Blood Institute~   "
17997|NCT03331367|"~     This study is a clinical study to investigate and characterize the immune response profile to~     four different prostate cancer treatments (total cryotherapy, focal cryotherapy, Cyberknife~     SBRT, and radical prostatectomy) in patients with localized prostate cancer.~   "
17998|NCT03331354|"~     64,000 Veterans are released annually from jails and prisons. These Veterans have a weekly~     unemployment rate of up to 40-55%. However, many are unable to access traditional vocational~     rehabilitation, not to mention specialized vocational rehabilitation for those with felony~     histories. Distance learning may be effective in improving access to rehabilitation as well~     as improving employment outcomes. The Compass system was developed to incorporate both~     synchronous and asynchronous distance learning to provide effective services. This study will~     evaluate 150 Veterans with histories of legal convictions and mental illness and/or a~     substance use disorder. Veterans will be randomly assigned to either a basic vocational~     resources condition or the the Compass condition. In the basic condition, Veterans will be~     provided with basic information about where they can access vocational services and a paper~     version of a vocational reintegration manual, specifically the About Face Vocational Manual.~     Veterans assigned to the Compass condition will be given access to the online instruction~     through Videos, live chat features, and tele-health practice interviews with feedback.~     Veterans will be followed for 6 months. The primary outcomes are employment and interview~     skills.~   "
17999|NCT03331341|"~     This phase II trial studies the side effects of doxorubicin hydrochloride, pembrolizumab,~     vinblastine, and dacarbazine in treating patients with classical Hodgkin Lymphoma. Drugs used~     in chemotherapy, such as doxorubicin hydrochloride, vinblastine, and dacarbazine, work in~     different ways to stop the growth of cancer cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as~     pembrolizumab, may interfere with the ability of cancer cells to grow and spread. Giving~     doxorubicin hydrochloride, pembrolizumab, vinblastine, and dacarbazine may work better in~     treating classical Hodgkin lymphoma.~   "
18000|NCT03331328|"~     Aim of the study: To assess the efficacy of MonaLisa Touch procedure for the management of~     genitourinary syndrome of menopause (GSM) in a randomized double-blind placebo controlled~     study.~   "
18001|NCT03331315|"~     Randomized control trial between ketorolac versus celecoxib for postoperative pain following~     hysterectomy.~   "
18002|NCT03331302|"~     Hyper polarized Xenon-129 MRI will be directly compared to a radioactive Xe-133 scintigraphy~     to detect defects in lung ventilation from airflow limitation. This study is conducted as a~     pilot study with intention to conduct a larger clinical trial.~   "
18003|NCT03331289|"~     Research Design/Plan: After screening, each subject will receive 1 measurements of EGP with~     prime-continuous Infusion of 3-3H-glucose. After completing the EGP measurement each subject~     will receive a Double Tracer OGTT.~      Methods: Visit 1: Screening. Medical history will be obtained, physical exam performed, and~     pregnancy test performed.~      Visit 2: Endogenous Glucose Production Measurement: The rate of EGP will be measured with~     3-3H-glucose.~      Visit 3: Double Tracer OGTT~   "
18005|NCT03331263|"~     A single 2% topical application of ReadyPrep® CHG was applied on either the abdomen~     (Treatment-1) or the groin (Treatment-2) whereas Treatment-3 consisted of a control treatment~     where the same procedure as Treatment-1 and -2 was performed, but without the topical~     application of ReadyPrep® CHG. The treatments were separated by a wash-out of 7 calendar~     days.~   "
18006|NCT03331250|"~     This research study is studying a drug as a possible treatment for Angiosarcoma or~     Epithelioid hemangioendothelioma (EHE).~      -The drug involved in this study is Eribulin~   "
18007|NCT03331237|"~     For shoulder analgesia, both ISO block and low volume scalene (LVS) block (using 5 ml of~     local anesthetics) are suggested to have a low incidence of hemi-diaphragmatic pariesis~     (HDP).~      The aim of this study was to compare the incidence of HDP and the analgesic efficacy of the~     LVS block versus ISO block.~   "
18008|NCT03331224|"~     Prospective-randomized multi-center trial. Patients with high risk of recurrent GI-bleeding~     (non-variceal) are identified and randomized into either endoscopic treatment with the OTSC~     [Over The Scope Clip] or endoscopic standard therapy. Hypothesis: Endoscopic therapy with~     OTSC is superior to standard therapy regarding technical success and rebleeding.~   "
18009|NCT03331211|"~     Philadelphia-chromosome-positive or partial ph-like acute lymphoblastic leukemia (ALL)~     preferred chemotherapy combined with tyrosine kinase inhibitors (TKIS) therapy. Recently we~     found that there were cytomegalovirus reactivation and even cytomegalovirus infection in~     three ALL patients treated with chemotherapy combined with TKIs. However, the cytomegalovirus~     risk after dasatinib use in patients with philadelphia-chromosome-positive ALL is still~     unknown. It is reported that dasatinib can be observed in the treatment of~     philadelphia-chromosome-positive leukemia patients with significant increase in large~     granular lymphocytes, the cytomegalovirus is often positive, and this part of the patient's~     prognosis is relatively good. Dasatinib can inhibit SRC and TEC kinase, and induce immune~     function inhibition,and in vitro experiments have confirmed that it inhibits the immune~     function of T cells and NK cells. In this study, we examined the potential association~     between cytomegalovirus AND EBV reactivation the treatment of chemotherapy combined with~     TKIs, and the numbers of large granular cells and NK cell activity.~   "
18010|NCT03331198|"~     This is a Phase 1/2, open-label, multicenter study to determine the efficacy and safety of~     JCAR017 in adult subjects with relapsed or refractory CLL or SLL. The study will include a~     Phase 1 part to determine the recommended dose of JCAR017 monotherapy in subjects with~     relapsed or refractory CLL or SLL, followed by a Phase 2 randomized part to assess JCAR017~     monotherapy treatment versus standard of care. A separate Phase 1 cohort will assess the~     combination of JCAR017 and concurrent ibrutinib. In all subjects, the safety, efficacy, and~     pharmacokinetics (PK) of JCAR017 will be evaluated.~   "
18011|NCT03331185|"~     A Clinical Trial to study the effectiveness between two, tooth socket grafting materials~     namely, Freeze Dried Bone Allograft (human derived bone particles) and Leukocytic-Platelet~     Rich Fibrin (the patient's own centrifuged blood).~      The purpose of this study is to compare the effects (good and bad) of Bone Allograft to~     Platelet Rich Fibrin to see which material would be the most effective in maintaining the~     volume of the gum and bone of the jaw during the healing phase as well as minimizing the~     amount of pain and/or swelling following tooth extraction.~   "
18012|NCT03331172|"~     High Intensity Focused Ultrasound (HIFU) is a new approach in treating benign thyroid nodule~     without surgery. It is proven effective and safe relative to traditional surgery. From~     previous HIFU studies, it caused shrinkage of thyroid nodule up to 70% from original size.~     Unfortunately, 5-10% of nodule do not shrink. Those which do not shrink are usually large in~     size and therefore a second HIFU treatment may help. This study is going to evaluate the~     efficacy and safety of reapplication HIFU after the first single HIFU session in 6 months.~      The study will be carried out in the following steps:~        1. Recruit subject from the clinic according to the study criteria.~        2. Arrange the reapplication HIFU treatment within 3 months.~        3. Arrange 4 visits after the HIFU treatment in Post 7 days, Post 1 month, Post 3 months,~          and Post 6 months; Data collection will be in these 4 visits through the questionnaire~          or interview by research assistant~        4. The subjects will have further health management with the same team after the study.~   "
18013|NCT03331159|"~     The aim of this study was to determine whether instrumented anterior lumbar interbody Fusion~     with a new nanocrystalline hydroxyapatite embedded in a silica gel matrix (NH-SiO2) was~     associated with superior radiological and clinical outcomes at 12 months follow-up compared~     with instrumented ALIF with homologous bone~   "
18014|NCT03331146|"~     The main objective of this study is to evaluate the efficacy of intravenous sodium nitrite~     compared with placebo in reducing the occurrence of CSA-AK as diagnosed by KDIGO criteria~     during the first 72 hrs after cardiac surgery in high-risk patients undergoing cardiac~     surgery. Secondary objectives are to determine whether IV sodium nitrite achieves adequate~     pharmacokinetics (PK) in patients undergoing cardiac surgery with the use of CPB.~   "
18015|NCT03331133|"~     The 2-BIG is a twin birth cohort study located in Guangzhou, China.Its initial aim is to~     facilitate research on understanding the interplay between genes and environmental factors on~     disease etiology. Data are collected regarding environmental, family and lifestyle exposures~     on twins from birth to 18 years old. Biological samples including blood and tissue samples~     are also collected from the twins and their parents.~   "
18016|NCT03331120|"~     Nonspecific neck pain (NSNP) is among the most common problems a physical therapy faces. it~     represents a major social and economic problem to society with high incidence rate between 22~     and 70% of the population and increases with age and female gender. Unknown etiology~     represents 85% percent or more of etiological factors responsible for the NSNP.~      Neck patients have greater postural instability compared to normal subjects signified by the~     increased excursion of the center of gravity (COG).and also increased postural instability~     has a significant correlation with pain and proprioceptive dysfunction.~      So the important question about the precise treatment protocol is almost a subject of debate.~     The use of conventional cervical collar treatment for chronic mechanical neck pain is one of~     the most debating modality. It also highlights the Controversy about the values of this type~     of treatment. It is postulated that this type of treatment is not without critique.~      Although posture has emerged as one of the important etiological factors reported to be~     associated with NSNP. most of the previous bracing concept limited their role to~     immobilization especially in the acute stage to create the best conditions for soft tissue~     healing and relieving pain by lowering the nociceptive physical and mechanical input.~     Moreover, it based on the dated concept when the 3D nature of posture was not incorporated~     into the brace design.~      It is postulated that large deviations from ideal postural alignment especially from the~     trunk which is approximately 60% of body mass have a negative influence on neural, muscular,~     and vascular tissues, resulting in various spinal disorders. Through the years, many studies~     have supported that many of our postural reflexes, such as the vestibulocollic~     reflex,cervicocollic reflex, pelvoocular reflex, vestibular-ocular reflex, cervical-ocular~     reflex and cervical somatosensory input, are housed, or occur, within the head and neck~     region. A correction of altered head posture, therefore, could be commanded to achieve~     optimal full spine postural correction, where the rest of the spine orients itself in a~     top-down fashion.~      And so global posture assessment and correction in view of three-dimensional analysis are~     important aspects that have to be considered in the bracing design if we seek greater and~     longer lasting improved function.~      Regarding the objective postural measurement methods, there are several tools available for~     clinical use. These include simple plumb line measure, photographic techniques, moire~     topography, various computer-assisted methods including electrogoniometers.~      There is evidence that this clinical evaluation is an effective tool, but as beneficial as~     this type of evaluation has proven to be, there are still various shortcomings as the most of~     these methods are not able to measure trunk posture as rotations and translations in six~     degrees of freedom as described by Harrison et al. And so in the current study we will use~     Global Postural System (GPS) which is a novice unique device investigating all postural and~     balance variables at once. GPS is a valid and reliable tool, provides the managing~     physiotherapist with a radiation-free accurate measurement. Moreover, it provides further~     information on trunk balance and other 3D features upon which bracing design can be tailored~     per each patient.~      Numerous studies showed that mirror Image and mirror image in motion exercises which are~     prescribed specifically to help normalize the patient's neuromuscular dysfunction and~     postural deformation through reflecting the patient's posture across different planes are~     more beneficial than a less personalized program. With these consideration in mind, and to~     incorporate the findings of 3D postural assessment into the treatment program, we will design~     an adjustable cervical thoracic Posture corrective Orthotic (TEPCO) which is worn by the~     patient for short time and have the availability to reflect all transitional displacements~     and rotational movements of the head then Ambulatory exercises are performed by using~     treadmill while the patient's reverse posture is held by the TEPCO. Accordingly, the purpose~     of the current study is to investigate the efficacy of ambulatory adjustable cervical~     thoracic orthosis on pain and 3D pasture parameters.~   "
18017|NCT03331107|"~     Nasal obstruction is a very subjective sensation but it's also a frequent reason of~     consultation. Two specific questionnaire NOSE and RhinoQOL were validated; but rhinomanometry~     value is still a question to debate. As well as the difference between acoustic rhinometry~     and rhinomanometry.~      Usually nasal obstruction due to a septal deviation is treated by septoplasty. If the~     anatomic result can be proved true, the patient's felt would be unsuccessful.~      The aim of this study is to assess the impact of septoplasty on the nasal obstruction,~     objectively by rhinometry and subjectively by questionnaire.~   "
18018|NCT03331094|"~     The objective of the study will be to estimate the correction obtained with a metallic~     instrumentation, by mini-invasive technique with bipolar assembly and ilio-sacred EUROS ®)~     screw , without transplant at the adult as compared to that obtained with the surgery with~     complete exhibition of the rachis and bone graft.~   "
18022|NCT03331042|"~     The purpose of this study is to investigate the effectiveness, safety and tolerability of a~     combination drug product (SM-1) containing diphenhydramine, zolpidem and lorazepam, in adult~     participants who sometimes have difficulty in falling asleep or staying asleep, but who do~     not have chronic insomnia. Participants will receive SM-1, or a combination of~     diphenhydramine and zolpidem, or a combination of diphenhydramine and lorazepam, or placebo~     during 4 one-night stays at a sleep center.~   "
18023|NCT03331029|"~     Chronic atrial fibrillation is a challenging arrhythmia requiring additional radiofrequency~     ablation besides pulmonary vein isolation. Atrial contractility in these patients is often~     impaired. Until now mapping catheters were used on virtual geometry maps of left atrium.~     However, changes in atrial volume cannot be assessed with these systems Assessments of atrial~     volumes with echocardiography relies on 2D and 3D measurements and modeling. The AcQMapTM 3D~     High Resolution Imaging and Mapping System (AcQMap) has a unique 3D array of ultrasound~     crystals, which can measure true 3D dimensions of the heart chamber. For the first time, true~     atrial volumes can be measured. Changing from atrial fibrillation to sinus rhythm causes~     changes in atrial volume and might be associated with quantitative systolic and diastolic~     function of the left ventricle measured with the Transesophageal Echocardiography.~   "
18024|NCT03331016|"~     Heart to Heart is a brief pregnancy prevention training program delivered to foster and~     kinship caregivers to prevent unintended pregnancy in foster youth. The training delivers~     easy to understand information on sexual health, contraception, and adolescent development.~     It also includes a brief behavioral training, and information on effective communication,~     monitoring strategies, and social support. The curriculum was piloted in Los Angeles.~     Investigators will test the intervention in a randomized control trial.~   "
18025|NCT03331003|"~     Current effective therapies of pattern hiar loss are topical minoxidil and oral finasteride.~     Finasteride is an inhibitor of type 2 5α-reductase and will cause hypospadias in male infant~     if taken or touched by pregnant woman. The effect of minoxidil is still known now but the~     dilation of scalp vessel might improve the progression of pattern hair oss. However,~     minoxidil is not effective for frontotemporal recession and sometimes cause scalp irritation.~      Low-level laser therapy (LLLT) a new therapy to treat alopecia. In 2007, LLLT was approved by~     the FDA as a treatment for hair loss. In some small studies, patients had a decrease in the~     number of vellus hairs, an increase in the number of terminal hairs, and an increase in shaft~     diameter. Up to now, however, no longer, placebo-controlled studies have proved its efficacy~     in this application.~      According to the mechanism of paradoxical hair growth (PHG), sublethal injury to the hair~     follicle could stimulate the hair follicle to enter anagen via the release of factors that~     alter angiogenesis, leading to increased blood flow to the dermal papilla. Furthermore, load~     inflammation in the papilla nad heat shok response, possibly mediated by HSP27, may play a~     role in activation of follicular stem cell.~      This study is a randomized, blinded, self-comparison and superior clinical trial design. In~     this clinical trial, the investigators try to evaluate the efficacy of low-level laser~     therapy in treating pattern hair loss. Pattern hair loss is characterized by increased vellus~     hairs and decreased shaft diameter, and these features are improved by LLLT in previous.~   "
18026|NCT03330990|"~     This is an open-label study in advanced solid tumor patients to determine if entrectinib~     affects the pharmacokinetics of midazolam and any of its pharmacologically active~     metabolites.~   "
18027|NCT03330977|"~     Objective of this study is to assess the efficiency of NOVATEX MEDICAL pressure garments in~     patients with an Ehlers-Danlos syndrome (EDS).~      To answer this objectif a comparison before/after use of pressure garments will be performed~     for all patients.~   "
18028|NCT03330964|"~     The clinical trail of electroacupuncture combined with oxaliplatin regimen on~     gastrointestinal carcinoma.This trail is randomized controled.Patients are diagnosed~     gastrointestinal cancer based on pathology or cell biology.They are randomized into 2~     groups:both groups receive Oxaliplatin regimen.The treatment group receives~     electroacupuncture in addition to the chemotherapy.The control group only receive the same~     chemotherapy with the treatment group.Both group have the same adjuvant therapy.~   "
18029|NCT03330951|"~     This is an observational study at the Obstetrical outpatient clinic at Stavanger University~     Hospital. The main goal is to compare the current marker of glycemic control (glycated~     hemoglobin A1c, HbA1c) with glycated albumin in pregnancies with pregestational diabetes~     mellitus.~      Women with diabetes are at increased risk for adverse pregnancy outcomes. With improved~     glycemic control, the risk decreases. Glycated albumin is suggested to be a better marker for~     monitoring glycemic control in pregnancies because it reflects blood glucose for a shorter~     period than HbA1c (3 versus 8-12 weeks). Other studies have shown that HbA1c increases in~     pregnancy because of iron deficiency. The investigators want to investigate HbA1c, glycated~     albumin and iron status in diabetic pregnancies. The investigators will compare HbA1c and~     glycated albumin throughout pregnancy with the patient's own blood glucose measurements or~     data from CGM (continuous blood glucose monitoring). Blood samples for HbA1c and glycated~     albumin will be taken 6 times during pregnancy (week 12, 20, 24, 28, 32, 36).~   "
18030|NCT03330938|"~     This study evaluates the effect of a single cognitive-behavioral intervention (CBI) in a~     control group against the same CBI plus the strengthening of resiliency skills in an~     experimental group, on ESRD patients.~   "
18031|NCT03330925|"~     The main objective of this study is to demonstrate the safety and the feasibility of this~     device, and its ability to increase venous blood flow~      Primary safety Endpoint:~      To demonstrate the safety of the device- no serious adverse effect~      Primary feasibility Endpoint:~      Increase the blood flow velocity~      The blood flow will be detected by a Duplex Ultrasonography test at the popliteal vein and~     the femoral vein.~      The volunteers will rest at controlled environment room . Measurements will be performed~     after 30 min of rest without the device on the leg (baseline) and after 30 min of device~     activity .~   "
18032|NCT03330912|"~     This study evaluates the effect of seat height on hemiplegic-pattern wheelchair propulsion.~     Each subject will act as their own control and measures will be obtained in a one sixty~     minute session. Five seat heights relative to the subject's leg length will be measured in a~     random order to see the effect on forward and backwards wheelchair propulsion.~   "
18033|NCT03330899|"~     The overall aim of this study is to evaluate the safety, immunogenicity and dose sparing~     effects of H7N9 influenza antigen formulated with 2 different adjuvants .~   "
18034|NCT03330886|"~     The main purpose is to study the safety and effectiveness of atezolizumab in patients with~     locally advanced or metastatic urothelial carcinoma whose disease has worsened during or~     following platinum-containing chemotherapy, or within 12 months of receiving~     platinum-containing chemotherapy, either before (neoadjuvant) or after (adjuvant) surgical~     treatment in common clinical practice settings in Argentina.~   "
18035|NCT03330873|"~     Asherman's syndrome is characterized by the presence of intrauterine adhesions (IUA) as well~     as symptoms such as amenorrhea, hypomenorrhea, pelvic pain, and infertility. The gold~     standard for the treatment of intrauterine adhesions is hysteroscopic intrauterine adhesions.~     The recurrence of intrauterine adhesions is a major challenge in clinical practice. The~     isolation of barriers in the uterine cavity may be a measure to reduce postoperative re~     adhesion, but the effect of different devices is different. Therefore, this study was~     conducted.~   "
18036|NCT03330860|"~     Objective: To evaluate the effectiveness of 12 knowledge transfer clips of maternal and~     neonatal health in order to generate knowledge appropriation. Methodology: Randomized~     cross-over clinical trial with a non-probabilistic sample of intentional feature of 150~     subjects: pregnant women, non-pregnant women and men. Participants will be evaluated during~     the observation of 13 clips (one of them is the control clip) in which sequence will be~     assigned randomly. The level of attention will be assessed by means of eye tracking, to see~     the ocular gaze and fixation in relation to the content of clips, and emotional reaction~     through the psychophysiological record (galvanic skin response). In addition, recall of~     information will be assessed through the application of questionnaires at the end of each~     video. The analysis will focus on identifying differences in the three outcomes between~     intervention clips and the control clip, and between the three groups, and determine the~     clips and segments that generate greater emotional response, attention and recall.~   "
18037|NCT03330847|"~     This study is to assess the efficacy and safety of olaparib monotherapy versus olaparib in~     combination with an inhibitor of ATR (Ataxia-Telangiectasia Mutated (ATM) and Rad3-related~     protein kinase (AZD6738) and olaparib monotherapy versus olaparib in combination with an~     inhibitor of WEE1 (AZD1775) in second or third line setting in patients with Triple-negative~     breast cancer (TNBC) prospectively stratified by presence/absence of qualifying tumour~     mutation in genes involved in the homologous recombination repair (HRR) pathway. Treatment~     arms are olaparib monotherapy, olaparib+AZD6738 and olaparib+AZD1775. The study subject~     population will be divided into Stratum A, Stratum B, and Stratum C. Due to the different~     schedules of administration of each of the treatment options as well as their different~     toxicity profiles, the study is not blinded. Study has two stage consent process- stage 1~     consent (molecular screening for HRR defects) and stage 2 consent (main study). Patients with~     TNBC and with known qualifying BRCAm, non BRCAm HRRm and non HRRm status will be offered the~     option of consenting to the main part of the study within the 28-day screening period.~     Approximately 450 patients will be randomised (using randomisation ratio 1:1:1) to 3~     treatment arms.~   "
18038|NCT03330834|"~     The NSCLC patients who failed the standard treatments, with positive Programmed Death-Ligand~     1 (PD-L1) expression, were enrolled into this trial. About 22 advanced NSCLC patients will be~     screened according to the criteria. The qualified patients will be recruited and sign the~     informed consent.Participants will be hospitalized and undergo clinical examinations.~      Appropriate volume of peripheral blood will be draw (from 66 ml to 360 ml, depend on the body~     weight and blood routine test), using Ficoll method to centrifuge peripheral blood cell and~     collected T cells. PD-L1 CAR gene is cloned in a lenti-viral vector that was composed of T~     cell activation molecules (Cluster of Differentiation 137 (CD137/4-1BB) and Cluster of~     Differentiation 3(CD3) zeta intracellular domains) and PD-L1 single-chain variable~     fragment(scFv) derived from the variable regions of a PD-L1 monoclonal antibody.Then,~     investigators packaged pseudo-lentiviral particles in human embryonic kidney (293T) cells~     that will be used to transduce autologous T cells isolated from the patients. CAR positive T~     lymphocytes will be determined by FACS with florescence labeled goat anti-human F(ab')2. The~     plasmids, pseudo-lentiviral particles and transduced T cells will be subject to the~     stipulated tests by a third party.~      Patients will receive leukodepletion chemotherapy (cyclophosphamide: 250mg/m^2 × 3 days;~     fludarabine: 25mg/m^2× 3 days). One day later, the chemotherapeutic effects would be~     assessed. PD-L1 CAR-T cells will be infused on day 0 with 10%, day 3 with 30% and day 7 with~     60% (total number is (1-2)×10^6/kg). The patients will be observed closely for any adverse~     reactions and if happened, given supportive treatments.~      The patients will be discharged on day 14 and will be followed up for two years according to~     the study scheme, i.e. once a month for the first three months; once every two months in the~     first year; since then, once a quarter in the second year. The persistence of PD-L1 CAR-T~     cells in the circulation will be monitored by fluorescent activated cell sorting (FACS) and~     polymerase chain reaction (PCR). If the patients undergo core needle biopsy, the infiltration~     of CAR positive cells in the tumor tissue will be evaluated by immunohistochemistry (IHC).~     The safety profile and anti-tumor efficacy of the CAR-T cells immunotherapy will be assessed~     during the whole process based on CTCAE v4.1 and RECIST v1.1.~   "
18039|NCT03330821|"~     This phase Ib/II trial studies the side effects and best dose of pevonedistat and to see how~     well it works in combination with cytarabine and idarubicin in treating patients with acute~     myeloid leukemia. Pevonedistat may stop the growth of cancer cells by blocking some of the~     enzymes needed for cell growth. Drugs used in chemotherapy, such as cytarabine and~     idarubicin, work in different ways to stop the growth of cancer cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Given~     pevonedistat, cytarabine, and idarubicin may work better in treating patients with acute~     myeloid leukemia.~   "
18040|NCT03330808|"~     Comparing the changes of arterial anastomotic blood flow between general anesthesia alone and~     general anesthesia with epidural anesthesia in patients who undergoing free flap~     transposition using Duplex ultrasound.~   "
18041|NCT03330795|"~     The purpose of this study is to determine whether bilateral orthotopic lung transplantation~     (BOLT) followed by cadaveric partially-matched CD3+/CD19+ depleted bone marrow transplant~     (BMT) is safe and effective for individuals aged 10 through 45 years with the diagnosis of~     primary immunodeficiency (PID) and end-stage lung disease.~   "
18042|NCT03330782|"~     Elderly patients show different pharmacokinetic and pharmacodynamic variables and usually~     need smaller doses of anesthetic drugs than younger patients. The purpose of this study was~     to investigate the optimal effect-site concentration of remifentanil for preventing injection~     pain during propofol induction in elderly patients by the Dixon's up-and-down method.~   "
18088|NCT03330171|"~     This trial will evaluate the safety and immunogenicity of: i) measles vaccine (CAM-70) after~     primary dose at 6 months (MV1) and booster vaccination at 12 months (MV2); ii) a single dose~     of varicella vaccination at 18 months; and iii) a single dose of hepatitis-A vaccination at~     18 months in HIV-exposed and HIV-unexposed South African children.~   "
18043|NCT03330769|"~     BACKGROUND Psoriatic arthritis (PsA) is a systemic inflammatory disease with articular and~     extra-articular features. Establishing the prognosis of a patient with PsA is hence important~     to define the treatment strategy. Currently, observational and prospective cohort studies~     have identified prognostic factors correlating with the achievement of therapeutic response.~     Nevertheless, despite the importance of identifying prognostic factors in a disease with a~     functional disability comparable to rheumatoid arthritis, the studies are still limited.~      PRIMARY OBJECTIVE In PsA with clinically active joint disease starting a new course of~     therapy, to evaluate the additional value of UltraSound(US)-score over clinical examination~     in detecting patients achieving MDA at 6 months.~      STUDY DESIGN The study follows a multi-centre observational prospective cohort study design.~      PATIENTS AND METHODS INCLUSION CRITERIA~        -  Adult > 18 years of age with PsA (PsA according to the ClASsification criteria for~          Psoriatic Arthritis (CASPAR) - with joint involvement)~        -  At least one joint clinically involved (both swelling and tenderness);~        -  prescription of new course of d NSAIDs (monotherapy), steroid intra-articular injections~          (monotherapy), conventional Disease-Modifying AntiRheumatic Drugs (DMARDs), biologic~          DMARDs, including switches or dose augmentations indicated by the treating~          rheumatologist according to usual clinical practice before US acquisition;~        -  Stable treatment before treatment modification (6 weeks);~        -  Signed informed consent form.~      CLINICAL ASSESSMENT Patient's clinical assessment will be performed according to the core set~     of domains for PsA proposed by the Group for Research and Assessment of Psoriasis and~     Psoriatic Arthritis (GRAPPA) and Outcome Measures in Rheumatology (OMERACT).~      ULTRASOUND ASSESSMENT Sonographic evaluations will be performed by expert ultrasonographers~     in 44 joints, 36 tendons, 12 entheses and 2 bursae according to the score developed for~     psoriatic arthritis by the study group ultrasound of the Italian Society of Rheumatology~     (US-score PsA-SIR)~      EXPECTED RESULTS AND SIGNIFICANCE The aim of this study is to identify clinical and US~     predictors of achieving MDA in PsA patients with active peripheral arthritis starting a new~     course of therapy.~   "
18044|NCT03330756|"~     It is estimated that there will be 439-552 million people with type 2 diabetes mellitus~     (T2DM) globally in 2030. Type 2 Diabetes Mellitus is present in one quarter of patients at~     the bariatric outpatient clinic. It is undecided which metabolic surgery grants best results~     in the remission of T2DM and which procedure does that at the lowest rate of surgical~     complications, long term difficulties and side effects. Non alcoholic fatty liver disease~     (NAFLD) is present in 80% of all morbidly obese subjects and is a major risk factor for~     development of insulin resistance and non alcoholic steatohepatis (NASH). It is increasingly~     recognized that the immune system, possibly driven by innate lymphoid cells (ILC's), and the~     intestinal microbiome are major players in this obesity related disease and the switch from~     benign to malign (insulin resistance and T2DM) obesity. However, the exact mechanisms of~     action behind the surgery-driven switch back from malign to benign obesity are~     unknown.Primary objective is to evaluate and compare the glycaemic control in T2DM within the~     first year of LRYGB and LMBG. Secondary aim is to gain insight in the pathophysiological~     mechanisms that drive the conversion of malign to benign obesity.~   "
18045|NCT03330743|"~     The purpose of this clinical trial is to identify the most effective strategy for~     intervention to change behaviors and affect weight status in obese children 2-5 years of age~     within the context of early childhood education centers.~   "
18046|NCT03330730|"~     The main objective of the project is to compare the effectiveness and efficiency of~     innovative care through the IsereADOM home-care service package versus standard care in the~     prevention of unplanned hospitalizations in patients with cancer treatment. In accordance~     with the recommendations of the French High Authority of Health (HAS), a cost-utility~     analysis (ACU) will be implemented~   "
18047|NCT03330717|"~     The aim of the study is to compare the recovering period hospitalization length between~     between a group of patients with conventional sedation, a group using hypnosis as sedation~     during the surgery and a third group using hypnosis as a relaxation method and preparation~     but enjoying a classic sedation for their surgery.~   "
18048|NCT03330704|"~     Many patients with traumatic brain injuries (including strokes, blood clots, or other brain~     injuries) are given concentrated salt water solutions (hypertonic saline) in order to treat~     brain swelling (cerebral edema). Current therapies consist of a mixture of sodium and~     chloride, which can lead to high levels of serum chloride and increased total body water.~     High levels of chloride can cause acidosis, which can cause the body to function~     sub-optimally. Therefore, the investigators are proposing to use two concentrated solutions~     in these patients at the same time that will allow for a lower total volume of solution~     administration and reduce the rise in chloride to prevent acidosis. The main outcome will~     therefore be the patients sodium level, chloride level and serum pH.~   "
18049|NCT03330691|"~     Patients with relapsed or refractory leukemia often develop resistance to chemotherapy and~     some patients who relapse following CD19 directed therapy relapse with CD19 negative~     leukemia. For this reason, the investigators are attempting to use T-cells obtained directly~     from the patient, which can be genetically modified to express two chimeric antigen receptors~     (CARs). One is to recognize CD19 and the other is to recognize CD22, both of which are~     proteins expressed on the surface of the leukemic cell in patients with CD19+CD22+ leukemia.~     The CAR enables the T-cell to recognize and kill the leukemic cell through recognition of~     CD19 and CD22. This is a phase 1 study designed to determine the safety of the CAR+ T-cells~     and the feasibility of making enough to treat patients with CD19+CD22+ leukemia.~   "
18050|NCT03330678|"~     Healthy human gut contains a large number of bacteria, which belong to several different~     species. Some genes in these bacteria encode enzymes that the human body cannot produce.~     These enzymes can catalyze metabolic reactions in the distal small bowel. For instance,~     bacterial enzymes can breakdown indigestible dietary constituents, making available extra~     energy to the host. The current paradigm treats the human body as a 'metagenome', i.e. a~     composite of Homo sapiens genes and genes in the genomes of the colonizing bacteria.~      Till recently, accurate determination of bacterial gut flora was not possible. Recent~     development of multi-parallel sequencing techniques has allowed unbiased determination of~     profile of gut flora. These techniques have revealed changes in gut flora in several disease~     conditions, including those of the gastrointestinal tract and liver. This has prompted the~     use of drugs, such as probiotics to restore the gut flora.~      Probiotics contain living microorganisms, and are administered in an attempt to obtain health~     benefits by restoring normal gut flora. These preparations provide benefit to patients with~     several diseases, including childhood diarrhea, antibiotic-associated diarrhea, inflammatory~     bowel disease, vaginitis, etc. However, the mechanisms of their beneficial effects remains~     unclear. Gut microbiota appear to modulate the development of immune system and maintain a~     balance between Th17 and T regulatory cells in animals. However, it is not known whether~     administration of probiotics changes the profile (nature and relative density of various~     species) of gut flora, and whether these changes are short-lasted or persistent.~      This proposal aimed to study whether probiotic administration influences the gut bacterial~     profile and host immune responses. In addition, we wished to determine whether the changes in~     gut flora and immune responses persist after probiotic administration is stopped.~   "
18249|NCT03328052|"~     The MYnd Analytics PEER Online strategy utilizes EEG diagnostics to direct patients with~     psychiatric illnesses to the best medication treatments. This trial will evaluate patients~     with a diagnosis of depression who will either receive (1) PEER Online directed therapy or~     (2) conventional treatment without EEG guidance and will compare 6 month clinical and~     economic outcomes between these groups.~   "
18051|NCT03330665|"~     Physician empathy and reducing stress are major factors in attaining positive clinical~     outcomes for patients. Fostering empathy in medical students is particularly important as~     they are the future of the healthcare workforce and a trend of declining empathy during~     medical education may lead to decreased health care quality outcomes. Meditation may be an~     avenue to promote positive student attitudes including empathy, though very few studies have~     examined this idea through empirical research. Using validated measures, the Jefferson scale~     of empathy and the perceived stress scale, we seek to investigate whether use of a meditation~     app will be associated with higher levels of self-rated empathy and lower self-rated stress.~   "
18052|NCT03330652|"~     The meeting point of the patient and his/her immediate family with the health care system is~     complicated and traumatic. While having to deal with medicalization geared towards providing~     evidence-based and cost-effective medical care, the patient expects comprehensive, holistic~     care tailored to his/her needs, during hospitalization or in the community. A survey of 800~     stroke patients and their caregiver during the 1st year following acute stroke~     hospitalization will explore their unmet needs.~   "
18053|NCT03330639|"~     Description: Capsaicin (8- methyl-N-vanillyl-6-nonenamide) has been demonstrated to have a~     therapeutic effect in idiopathic rhinitis. We hypothesize that capsaicin has a therapeutic~     effect on rhinogenic headaches, in addition to the previously studied decongestive effects.~     This study aims to evaluate capsaicin impact on headaches attributed to V1, V2 distribution~     of the sinonasal cavity. This study is a randomized, double-blinded, parallel trial.~   "
18054|NCT03330626|"~     Although monitoring fluid balance for continuous renal replacement therapy-treated patients~     is an important issue, most physicians usually use conventional methods such as the~     difference between the amount of intake and output (I & O), which is not objective way.~     Meanwhile, bioimpedance electrical vector analysis presents the patients' fluid status with~     more objective data. Thus, the investigators will investigate the clinical benefit for~     monitoring fluid balance when the investigators use InBody S10, one of representative~     bioimpedance electrical vector analysis, compared with conventional methods among the~     patients who need continuous renal replacement therapy.~   "
18055|NCT03330613|"~     In this study, inhalation anesthesia procedure and intravenous anesthesia method will be~     compared in terms of emergence delirium and recovery time in children who are scheduled for~     dental treatment under general anesthesia.~   "
18056|NCT03330600|"~     Microcephaly associated with Congenital Syndrome of the Zika virus (SCVZ) was highlighted due~     to atypical structural and behavioral changes of the central nervous system. Such changes~     contribute to the appearance of functional impairments and difficulties of adaptation of the~     child to the necessary therapeutic follow-up. In this context, the search for adjuvant~     therapies that allow better management of these alterations has grown and, given its~     advantages, aquatic physiotherapy may be an auxiliary resource in the care of this~     population. The aquatic environment is capable of promoting a state of relaxation that, when~     associated with a kinesiotherapy protocol, is believed to have this potentiated effect. Thus,~     our objective will be to evaluate the efficacy of aquatic physiotherapy on the level of~     stress and muscle tone in children with microcephaly associated with SCVZ. A crossover,~     randomized, controlled and blind study will be carried out with children between 3 and 24~     months of age, who will undergo two interventions: aquatic physiotherapy and water immersion.~     The evaluation of muscle tone will be performed through the Tardieu scale before and after~     the intervention; the physiological parameters (heart and respiratory rate, oxygen saturation~     and temperature) and the stress level will be evaluated before, immediately after and 30~     minutes after the intervention. In addition, questionnaires will assess the child's~     behavioral state, level of irritation and sleep characteristics. For data normalization the~     Shapiro Wilk Test will be applied; the percentage values and relative frequency will be used~     for the descriptive analysis and for the numerical variables the values of mean and standard~     deviation or median and interquartile range. The paired T and ANOVA tests for repeated~     samples will be applied, which will analyze the intra-group time factor for the dependent~     variables of each individual. And for intergroup analysis, the variables may be submitted to~     the T-Test for independent or Mann-Whitney samples.~   "
18057|NCT03330587|"~     The purpose of this study is to better understand the experience of living alone in older age~     with cognitive impairment.~      We recruit adults 55+ living alone with cognitive impairment such as Alzheimer's disease or~     mild cognitive impairment.~      This study investigates the priorities and concerns of older adults living alone with~     cognitive impairment. Participants are interviewed 5 times for one hour in their homes within~     3 months at a time that works for them.~   "
18058|NCT03330574|"~     The purpose of this trial is to evaluate the performance of a new diagnostic device in the~     diagnosis and management of glaucoma. We will use this new device (PERG) to evaluate the~     function of the retina in glaucoma patients. This device is safe for the patients.~   "
18059|NCT03330561|"~     A multi center, open-label, Phase 1 dose escalation study with expansion cohort is designed~     to determine the MTD, RP2D and dosing schedule of PRS-343 in patients with HER2+ advanced or~     metastatic solid tumors.~   "
18060|NCT03330548|"~     The purpose of this study is to conduct a preliminary test of the effectiveness of various~     educational interventions to promote adoption of a whole-food, plant-strong diet and reduce~     specific cardiovascular risk factors in Veterans, and subsequently perform a preliminary~     pilot study on whether this dietary approach will change plaque inflammation and endothelial~     function.~   "
18061|NCT03330535|"~     The aim of this study is to investigate the efficacy of text message active reminders at~     different time intervals of oral hygiene instructions in patients with orthodontic fixed~     appliances.~   "
18062|NCT03330522|"~     Background: Love, Sex, and Choices (LSC) is a soap opera video series created to reduce HIV~     sex risk in women.~      Methods: LSC was compared to text messages in a randomized trial in 238 high-risk mostly~     Black young urban women. 117 received 12-weekly LSC videos, 121 received 12-weekly HIV~     prevention messages on smartphones. Changes in unprotected sex with high risk partners were~     compared by mixed models.~   "
18089|NCT03330158|"~     The purpose of this biomedical research is to evaluate the feasibility of the treatment with~     the new spinal distraction device ASTS in patients aged 4 to 10 years with severe early onset~     scoliosis.~      The hypothesis of this project is that the new fully implantable motorized spinal distraction~     device may provide a correction of scoliosis and progressive elongation ensuring patient~     comfort and minimizing complications.~      The ASTS (for Active Scoliosis Treatment System) growing rod is a new fully implantable~     motorized spinal distraction device which can ensure a correction of scoliosis and~     progressive elongation ensuring patient comfort and minimizing complications.~   "
18090|NCT03330145|"~     The purpose of this study is to identify risk factors of Complicated Grief (CG) among~     children and adolescents who lost a parent to cancer or from an other cause.~   "
18063|NCT03330509|"~     Introduction~      There is a rising need for palliative care services in Singapore due to a rapidly ageing~     population and an increasing incidence of cancer. Current existing resources are inadequate -~     novel models of care are needed to expand access to palliative care without requiring~     significantly more specialist palliative care manpower.~      Oncologist-driven referrals to a palliative care consultation service is the norm worldwide,~     including Singapore. This results in variable access to palliative care due to differences in~     referral practices. Palliative care involvement is also often delayed. In this study, the~     investigators propose to test Supportive and Palliative care Review Kit (SPARK) - a novel~     integrated model of care in which the palliative care team co-rounds with the medical~     oncology team.~      Specific Aims and Hypothesis~      This study aims to evaluate the impact of SPARK compared to usual care. The study~     investigators hypothesize that SPARK will result in more advanced cancer patients having~     access to palliative care, and at the same time operate at lower net cost. The study~     investigators also hypothesize that the improved efficiency of SPARK will result in shorter~     hospital length of stay for stage 4 cancer patients.~      Methods~      A cluster randomized trial with step wedged design will be used to compare SPARK to usual~     care. Data will be collected on health services utilization and access to palliative care~     services. Net costs will also be compared between SPARK and usual care. Semi-structured~     interviews with patients and healthcare professionals will be used to explore differences in~     experiences of healthcare provision between both models of care.~      Importance~      Singapore has a rising prevalence of cancer patients who require palliative care input, but~     only a minority are able to access it at present. If the SPARK model of care proves to be a~     scalable and cost-effective way of expanding access to palliative care, more cancer patients~     can benefit from palliative care.~   "
18064|NCT03330496|"~     Pain assessments in non-verbal, critically ill infants represent an important clinical~     challenge. Older children or adults can easily express their pain, but infants lack that~     capability. They frequently experience repetitive acute pain during routine ICU care, but~     their analgesic management flounders on the horns of a dilemma: (a) failure to treat infant~     pain leads to immediate clinical instability and potentially long-term physical, behavioral,~     and cognitive sequelae, vs. (b) strong analgesics may increase risks for medical~     complications and/or impaired brain growth. Bedside nurses currently assess pain using pain~     scores, before taking action to ameliorate pain. Pain scores increase nursing workload and~     provide subjective assessments, rather than objective data for evaluating infant pain.~     Consequently, infants exposed to skin-breaking procedures, surgery, or other painful~     conditions often receive variable and inconsistent pain management in the ICU. The~     investigators aim to develop a multimodal pain assessment system, using sensor fusion and~     novel machine learning algorithms to provide an objective measure of pain that is~     context-dependent and rater-independent. This will enhance the quality of pain management in~     ICUs and allow continuous pain monitoring in real-time.~   "
18065|NCT03330483|"~     This study attempts to verify whether different types of catheters could impact on patients'~     feelings at the first-time catheter insertion at urodynamic study.~      Each patient will undergo an insertion of only one type of a catheter and will rate his/her~     pain and discomfort feelings.~   "
18066|NCT03330470|"~     The purpose of this study is to investigate the beneficial effects of regular exercise and~     the impact of food supplement carnosine on cognitive, motoric and metabolic functions as well~     as on specific biologically active substances in volunteers with subjective (SCI) or mild~     (MCI) cognitive impairment, as well as in patients in early stages of Parkinson's disease.~     The investigators assume the immediate intervention-associated health benefit for volunteers.~   "
18067|NCT03330457|"~     This is a randomized, double-blind, single center study in healthy volunteers dosed to steady~     state with betrixaban, designed to (1) Determine an andexanet dosing regimen required to~     reverse anticoagulant activity of betrixaban in healthy subjectss, (2) Assess the safety and~     tolerability of andexanet vs. placebo (3) Determine the PK properties of andexanet and~     betrixaban (4) Determine the PD properties of betrixaban before, during, and after receiving~     andexanet or placebo and (5) Investigate the immunogenicity of andexanet in the presence of~     betrixaban.~   "
18068|NCT03330444|"~     Although the endometrium tissue has been traditionally considered free of bacteria, recent~     studies have documented the presence of an endometrial microbiome. In a pilot study conducted~     by our research team, the microorganisms present in the endometrium were analysed in samples~     of endometrial fluid (EF) using next generation sequencing (NGS).Consistent with previously~     published studies, in normal conditions the endometrium is mainly composed of different~     species of the genus Lactobacillus. It was further noted that the presence of other~     pathogenic bacteria such as Streptococcus, and/or Gardnerella may alter the endometrial~     microbiome and can disrupt the uterine environment, affecting implantation rates and~     pregnancy success.~      This project aims to validate the microbiome found in the endometrium of women of~     reproductive age and try to corroborate the relationship between the endometrial microbiome~     and the reproductive outcomes in patients undergoing assisted reproduction treatment (ART),~     using the endometrial fluid samples to generate and validate a new diagnostic tool for~     non-invasive endometrial receptivity. The use of Endometrial Receptivity Analysis (ERA) tool,~     together with the analysis of the endometrial flora before the embryo transfer will allow to~     evaluate the impact of the presence of endometrial pathogens on implantation in receptive~     patients.~      Therefore, the focus of this project is the development and clinical validation of a~     non-invasive diagnosis tool to analyse simultaneously the endometrial receptivity and~     microbiota, adding the microbiome study to the ERA analysis. This new tool will allow to~     evaluate the endometrial factor in a comprehensive way by using non-invasive methods that~     avoid endometrial biopsy (EB) collection and the discomfort caused to the patients.~   "
18069|NCT03330431|"~     The study's aim is to determine whether a short video aiming to optimize expectations~     regarding the effectiveness of progressive muscle relaxation (PMR) ist able to improve the~     actual effectiveness of PMR in comparison with a neutral (no video) control group.~   "
18070|NCT03330418|"~     The purpose of this study is to initially observe the safety and effectivity of RC18 in~     Participants with Neuromyelitis Optica Spectrum Disorders.~   "
18071|NCT03330405|"~     Avelumab in combination with talazoparib will be investigated in patients with locally~     advanced (primary or recurrent) or metastatic solid tumors, including non-small cell lung~     cancer (NSCLC), triple negative breast cancer (TNBC), hormone receptor positive (HR+) breast~     cancer, recurrent platinum sensitive ovarian cancer, urothelial cancer (UC), and castration~     resistant prostate cancer (CRPC).~   "
18072|NCT03330392|"~     The researchers investigated the immune enhancing effects of AGP for Korean participants.~   "
18073|NCT03330379|"~     During invasive mechanical ventilation, maintaining endotracheal tube cuff pressure (Pcuff)~     around 25 cmH2O is recommended for sealing the upper airways. The continuous control of Pcuff~     with a simple mechanical device, the Tracoe Smart CuffmanagerTM, has never been assessed. The~     investigators hypothesize that the Tracoe Smart CuffmanagerTM would allow a reduction of the~     incidence of underinflation episodes, as compared with the intermittent strategy of Pcuff~     control.~   "
18075|NCT03330353|"~     The specific aim of this study is to investigate rod, cone and melanopsin driven pupillary~     light response in individuals with progressive supranuclear palsy (PSP), age-matched healthy~     controls and individuals with other neurodegenerative diseases using chromatic pupillometry,~     with special interest in assessing melanopsin-driven post-illumination pupil response (PIPR)~     as an identifier for PSP.~      The study addresses the following hypotheses:~        1. Chromatic pupil responses, including rod/cone-driven rapid phase constriction and~          melanopsin-driven PIPR, are reduced in subjects with PSP compared to age-matched normal~          healthy control subjects,~        2. Pupil parameters of the melanopsin-driven PIPR are abnormal in PSP subjects without~          supranuclear palsy, which is indicative of a subclinical physiological deficit of the~          OPN in the early stages of PSP.~      If these hypotheses are upheld, chromatic pupillometry to measure the PIPR promises to be a~     reliable in vivo, non-invasive, convenient and inexpensive technique to detect asymptomatic~     pupillomotor impairment in advance of diagnostic oculomotor signs and deterioration of~     cognitive function.~   "
18076|NCT03330340|"~     Based on the case reports and other literature, the investigators hypothesize that using PVP~     for treating GIOPVCF is associated with increased risk of vertebral refractures and does not~     provide further benefits compared to conservative treatments.~      The overall objective of this prospective cohort study is to compare the efficacy of PVP and~     conservative treatment for GIOPVCF. The evaluation of efficacy of therapy includes: 1) the~     incidence of vertebral refractures; 2) therapeutic effects (pain relief and health-related~     life quality) and 3) complications.~      The results from study will be written in English and disseminated widely through scholarly~     presentations, peer-reviewed publications, and other written communications.~   "
18077|NCT03330327|"~     This is a phase 1 study to assess and compare molar potency of HM12470 and regular human~     insulin in healthy subjects.~   "
18078|NCT03330314|"~     This is a phase 1 study to assess and compare molar potency of HM12460A and glargine in~     healthy subjects.~   "
18079|NCT03330301|"~     Vitamin D deficiency is common among otherwise healthy pregnant women and may have~     consequences for them as well as the early development and long-term health of their~     children. However, the importance of maternal vitamin D status has not been widely studied.~      The present study is divided into a societal experiment (1) and a case-cohort study (2):~        1. The present study includes an in-depth examination of the influence of exposure to~          vitamin D early in life and during critical periods of growth for development of type 1~          diabetes (T1D), type 2 diabetes, gestational diabetes, pre-eclampsia, obesity, asthma,~          arthritis, cancer, mental and cognitive disorders, congenital disorders, dental caries~          and bone fractures during child- and adulthood. The study is based on the fact that~          mandatory fortification of margarine with vitamin D, which initiated in 1937, was~          terminated in 1985.~           Apart from determining the influences of exposure prior to conception and during pre-~          and postnatal life, the investigators examined the importance of vitamin D exposure~          during specific seasons and trimesters, by comparing disease incidence among individuals~          born before and after the fortification.~        2. Additionally, a validated method was used to determine neonatal vitamin D status using~          stored dried blood spots (DBS) from individuals who develop the aforementioned disease~          entities as adults and their time and gender-matched controls.~      Unparalleled, the study will help determine the effects of vitamin D exposure during critical~     periods in life. There are a sufficient number of individuals to verify any effects during~     different gestation phases and seasons of the year. The results, which will change our~     current understanding of the significance of vitamin D, will enable new research in related~     fields, including interventional research designed to assess supplementation needs for~     different subgroups of pregnant women. Also, other health outcomes can subsequently be~     studied to generate multiple new interdisciplinary health research opportunities involving~     vitamin D.~   "
18080|NCT03330288|"~     The main purpose of this study is to evaluate how a long-term treatment with Theraflex during~     64 weeks affects pain intensity in the affected knee or hip joint, the activity in daily~     living, the quality of life and patient satisfaction with treatment.~   "
18081|NCT03330262|"~     The goal of this study is to evaluate a tactile prosthesis that provide individuals who have~     demonstrated chronic imbalance with help to maintain a correct sense of orientation with~     respect to the gravity and improve posture control.~   "
18082|NCT03330249|"~     The general aim is to compare the cumulative dose of cisplatin administered concomitantly~     with radiotherapy in reference arm A (cisplatin 100 mg / m2 day 1 every 21 days) and in the~     experimental arm B (Cisplatin split 25 mg / m2 / J D1 to D4 all 21 days).~   "
18083|NCT03330236|"~     The study is a prospective, double blinded, randomized and controlled parallel trial to~     investigate the impact of the anesthetic care guided by EEG monitor (SedLine).~   "
18084|NCT03330223|"~     The main purpose of our study is to investigate whether haemodialysis itself affects the~     efficacy of antiplatelet drugs and the effects of two different types of dialysis membranes~     (polysulfone membranes and polyamide membranes) on antiplatelet efficacy. A total of 60~     patients with ESRD and under dual-antiplatelet treatmen for at least 5 days will be enrolled~     and divided into the Clopidogrel group (clopidogrel 75mg qd;aspirin 100mg qd, n=30) and the~     Ticagrelor group (ticagrelor 90mg bid; aspirin 100mg qd, n=30). All included patients will~     receive haemodialysis by two different types of dialysis membrane.Platelet aggregation of~     venous blood from all patients will be detected by LTA and VerifyNow immediately before and~     after two times of haemodialysis.~   "
18085|NCT03330210|"~     Left atrial appendage closure (LAAC) was approved by the ESC guidelines as a stroke~     prevention alternative to warfarin for patients with nonvalvular atrial fibrillation in~     patients at high risk of bleeding (IIbB).~      Although the overall LAAC benefice, in term of prevention of stroke or embolisme and~     decresing the anticoagulant-related risk of bleeding is already demonstrated, however the~     procedure success and safety, critically depends on understanding LAA anatomy and adequate~     pre-procedure planning.~      3D-printed patient-specific adaptive and flexible LA models have demonstrated in a previous~     study an improving in LAAO device sizing, a better pre-procedural planning of the optimal~     trans-septal puncture site, by incorporating all anatomical variations and an improuving~     patient outcomes by reducing procedure time and number of prostheses employed per patient.~      This technique is now used in several surgical centers in France and large prospective~     evaluation of the practice is necessary.~   "
18086|NCT03330197|"~     This research study involves an investigational product: Ad-RTS-hIL-12 given with veledimex~     for production of human IL-12. IL-12 is a protein that can improve the body's natural~     response to disease by enhancing the ability of the immune system to kill tumor cells and may~     interfere with blood flow to the tumor.~      The main purpose of this study is to evaluate the safety and tolerability of a single tumor~     injection of Ad-RTS-hIL-12 given with oral veledimex in the pediatric population.~   "
18087|NCT03330184|"~     The aim of this study is to assess the beneficial effects of Bifidobacterium and Berberine~     Hydrochloride on lowering glucose and delaying progress to diabetes in patients with~     prediabetes and to detect the potential mechanism.~   "
18091|NCT03330132|"~     This study allows to evaluate the strength and duration of immune responses between annual~     receipt of standard inactivated vaccine and alternative potent vaccines, including annual~     receipt of adjuvanted inactivated vaccine, annual receipt of high-dose inactivated vaccine,~     annual receipt of recombinant HA vaccine, and the alternate combinations of the former three~     vaccines over four years, for identifying improved vaccination strategies for influenza~     vaccination in older adults in a location experiencing a subtropical pattern in influenza~     activity.~   "
18092|NCT03330119|"~     This randomized controlled trial will compare two different approaches to patient recovery~     after cesarean section: the current standard of care versus an alternate management protocol.~     The goal of this study is to investigate whether an alternate management protocol after~     cesarean sections will yield the same results as alternate management in other surgical~     fields, including decreased narcotic consumption and quicker return of bowel function,~     without compromising patient morbidity or satisfaction.~      The investigators will assess postoperative narcotic consumption as the primary outcome.~     Secondary outcomes will be return of bowel function, length of hospital stay, pain control,~     patient satisfaction, post-operative complications, and overall morbidity and mortality.~      Hypothesis: Initiating the alternate management protocol for cesarean sections will decrease~     narcotic consumption and hasten return of bowel function, without compromising patient~     satisfaction, level of pain control, or post-operative morbidity.~   "
18093|NCT03330106|"~     The purpose of this study is to characterize the effects of 25 and 50 milligram per square~     meter (mg/m^2) pevonedistat on the Fridericia corrected QT interval (QTcF) of the~     electrocardiogram (ECG).~   "
18094|NCT03330093|"~     This research project will examine whether experimental sleep extension in children alters~     the neural and behavioral mechanisms by which short sleep is a risk factor for~     emotional/behavioral problems. Children ages 5.0-5.9 years with chronic insufficient sleep~     (≤9 h/night for ≥6 months) will be randomized to either a sleep Extension or to an active~     Control group. Extension group parents will participate in a 1-month individualized~     behavioral sleep intervention to promote targeted sleep duration improvements before~     beginning a 2-week sleep Extension schedule (8 week protocol). Brain and behavioral~     assessments will occur at Baseline and post sleep Extension.~   "
18095|NCT03330080|"~     Pediatric craniopharyngioma patients experience significant endocrine and sleep dysregulation~     difficulties. Sleep is a crucial part of children's healthy development, and sleep~     difficulties are associated with severe functional morbidity. Insufficient sleep, excessive~     daytime sleepiness, and poor sleep quality have all been significantly related to academic,~     behavioral, and emotional functioning in children and adolescents. Ecological momentary~     assessments (EMA) will be used to collect observational data.~      EMA data will be collected twice daily for one week. For the morning EMA administration,~     participants will be asked about their sleep. During the evening administration, participants~     will be asked about their daytime sleepiness, overall well-being, and family functioning.~     Covariates also administered during the evening administration include medication~     administration (Y/N) and total screen time. At the end of the EMA data collection period (on~     day 7 OR 8), participants will be sent a survey asking them to report - anonymously - their~     overall experience and satisfaction with the EMA data collection method.~   "
18096|NCT03330067|"~     Laparoscopic surgery (surgery with the use of a camera and small instruments) uses~     insufflation, which is the standard medical practice where CO2 (carbon dioxide) gas is blown~     into the abdomen to create space for surgical procedures. The purpose of this study is to~     investigate whether heating and humidifying surgical CO2 will reduce surgery-related~     inflammation and postoperative pain.~   "
18097|NCT03330054|"~     This study evaluate the frequency and type of eye problem among Type 2 Diabetics with renal~     impairment and effect of renal impairment and haemodialysis on diabetic retinopathy~   "
18098|NCT03330041|"~     This study aims to investigate whether the spacing of the interrupted cutaneous sutures~     affects surgical wound cosmesis on the trunk and extremities. In other words, the~     investigators would like to determine which of the following yields a more cosmetically~     appealing scar: many closely approximated sutures or fewer, more widely spaced sutures. The~     investigators wish to compare the effects of two versus five millimeter spacing between~     sutures.~   "
18099|NCT03330028|"~     The goal of this clinical research study is to find the highest tolerable dose of paclitaxel~     that can be given as hyperthermic intraperitoneal chemotherapy (HIPEC) to patients with~     gastric or gastroesophageal cancer. HIPEC is a system in which heated chemotherapy is~     delivered directly inside the abdomen during surgery. In this study, paclitaxel is being~     combined with mitomycin and cisplatin to see if this study drug combination can help to~     control the disease.~      This is an investigational study. Mitomycin, cisplatin, and paclitaxel are FDA-approved and~     commercially available for the treatment of gastric and gastroesophageal cancer. It is~     investigational to give these drugs by HIPEC.~      The study doctor can describe how the study drugs and HIPEC are designed to work.~      Up to 48 participants will be enrolled in this study. All will take part at MD Anderson.~   "
18100|NCT03330015|"~     Endometrial cancer is the most common malignancy of the female genital tract in Hong Kong.~     The aim in the evaluation of PMB is to exclude underlying malignancy. Endometrial thickness~     (ET) measured by transvaginal ultrasound scanning (TVS) and endometrial biopsy or sampling~     (ES) has been recommended as the first-line investigation. From a study between 2002-2013 in~     the One-stop PMB clinic, investigators found that ET was able to identify women with~     endometrial cancer with the sensitivity at 3mm, 4mm, and 5mm, the current levels recommended~     in professional guidelines, being 97.0%, 94.1%, and 93.5% respectively. However, little is~     known about the level of patient's acceptance of the false negative rate and how patient~     would trade residual risk with more invasive test. There is also a lack of study on the~     experience of women during the management pathway especially the level of anxiety before and~     after investigations and the pain experienced from the investigations offered. The current~     study aim to study the level of false negative rate accepted by women for the investigation~     of PMB and the level of anxiety and pain experienced during the investigation pathway.~   "
18101|NCT03330002|"~     The aim of this observational post market study is to compile real world outcome data on the~     use of the Conformité Européenne (CE) marked MANTA Vascular Closure Device following~     percutaneous cardiac or peripheral procedures for large bore (10‐18F ID) interventional~     devices.~   "
18103|NCT03329976|"~     The prevalence of idiopathic epiretinal membranes (ERM) in people over 50 is estimated at 6~     to 19%. Even though most cases show very few symptomats, they may induce alterations of the~     underlying retina and lead to visual impairment likely to greatly diminish quality of life in~     patients. Thanks to the ever-improving quality of vitreo-retinal surgery, ablation of these~     membranes is a frequent and safe procedure allowing a functional gain in the majority of~     cases. Given the increasing prevalence in the population concerned and the accelerated ageing~     of the lens after vitrectomy, cataract surgery is often associated with removal of the~     membrane. On the basis of a study in 142 patients, it was possible to identify clinical and~     morphological prognostic factors and to inclure them in a score to assess the chances of~     complete functional recovery at one year following the procedure . Age of the patient, the~     duration of symptoms, initial visual acuity and the quality of the junction between external~     and internal segments of photoreceptors in optic coherence tomography (OCT) appeared as~     significantly related to visual results. Using this score in a new prospective cohort would~     allow the investigators to make it a reliable and easy-to-use tool at the service of~     ophthalmologist surgeons and their patients and would provide scientific confirmation of the~     interest of earlier surgery in this disease. It would also allow the investigators to define~     in a validated and reproducible manner, a threshold for an ndication for ERM surgery, which~     is currently based on relatively subjective criteria mostly related to visual acuity.~   "
18104|NCT03329963|"~     Obese older adults will be randomized to participate in either healthy lifestyle intervention~     or behavioral diet and exercise intervention for one year. This study aims to determine the~     effects of Lifestyle intervention on bone microarchitecture, bone strength, bone material~     properties, and the mechanism behind it.~   "
18105|NCT03329950|"~     This is a study to determine the maximum tolerated dose (MTD) for CDX-1140 and to further~     evaluate its tolerability and efficacy in expansion cohorts once the MTD is determined.~   "
18106|NCT03329937|"~     This is an open-label, single-arm pilot study evaluating the antitumor activity and safety of~     niraparib as neoadjuvant therapy in patients with HER2 negative and BRCAmut localized breast~     cancer (primary tumor >1 cm).~   "
18107|NCT03329924|"~     The hypothesis of this study is that an early mobilization program coupled with~     organizational efforts to implement the ABCDEF bundle will increase the rate of ICU patient~     mobilization and decrease the ICU length of stay, but will not significantly affect patient~     mortality. Mobilization efforts will be done to improve patient care and the study will allow~     for measurement of the effects of implementation of this effort. The early mobilization~     program is being instituted as standard of care. The study will measure the actual degree of~     change in patients' activity level and to evaluate the effect of the program on outcome~     measures such as length of stay.~   "
18108|NCT03329911|"~     This is a Phase III, randomized, double blind, multicenter, active comparator, parallel two~     arm study to compare the efficacy, and to evaluate the safety, and immunogenicity of BAT1706~     to EU Avastin® in patients with previously untreated advanced non-squamous non-small cell~     lung cancer (nsNSCLC) to demonstrate clinical equivalence of BAT1706 and EU Avastin®.~   "
18109|NCT03329898|"~     Asherman's syndrome is characterized by the presence of intrauterine adhesions (IUA) as well~     as symptoms such as amenorrhea, hypomenorrhea, pelvic pain, and infertility. The gold~     standard for the treatment of intrauterine adhesions is hysteroscopic intrauterine adhesions.~     The recurrence of intrauterine adhesions is a major challenge in clinical practice. It has~     been reported that dried biological aminion graft was used to prevent adhesion after the~     operation of intrauterine adhesions. Intrauterine balloon can reduce the recurrence of~     adhesions after operation. Does the combination of balloon and amniotic products can improve~     clinical outcomes? Therefore, this study was conducted.~   "
18110|NCT03329885|"~     The purpose of this study is to investigate experimental medication BMS-986251 taken by mouth~     in healthy patients and patients with average to very serious Psoriasis (a condition~     characterized by itchy, dry skin with a scaly rash).~   "
18111|NCT03329872|"~     Neuro-orthopedics corresponds to the evaluation and therapeutic management of the orthopedic~     consequences of damage to the central or peripheral nervous system. In case of neurological~     impairment, there may be joint, motor, sensory and cognitive impairments that limit the~     patient's activities. The management of these orthopedic problems falls within the specific~     framework of neuro-orthopedics because in the presence of neurological, problems are~     different and more complex than in classical orthopedics. In this context, a well-conducted~     evaluation is a prerequisite for appropriate treatment.~   "
18112|NCT03329859|"~     Objective: Investigators aimed to evaluate the impact of a high resolution standardized~     laparoscopic (HRSL) cholecystectomy protocol on operative time and intraoperative~     interruptions in a teaching hospital.~      Background: Interruptions of the surgical workflow or microcomplications (MC) lead to~     prolonged procedure times and costs and can be indicative for surgical mistakes. Reducing MC~     can improve operating room efficiency and prevent intraoperative complications.~      Methods: Audio video records of laparoscopic cholecystectomies were reviewed regarding type,~     frequency and duration of MC before and after the implementation of a HRSL which included the~     introduction of a stepwise protocol for the procedure and a teaching video. After consent~     operating team members were obliged to prepare the operation with these resources.~   "
18113|NCT03329846|"~     The purpose of this study is to see if BMS-986205 combined with nivolumab, compared to~     nivolumab by itself, is more effective in treating Melanoma that has spread or is unable to~     be removed by surgery, and has not previously been treated~   "
18114|NCT03329833|"~     The purpose of this study is to test the efficacy of a 6-month telephone-based motivational~     interviewing intervention and a web-based application intervention to improve physical~     activity in participants with Parkinson's Disease.~   "
18122|NCT03329716|"~     This is a non-blinded, randomized controlled trial for testing two brace weaning protocols~     namely immediate removal of brace or gradual weaning of brace over a course of 6 months for~     adolescent idiopathic scoliosis (AIS) patients. These patients will have follow-up visits at~     6-month and 12-month intervals. By comparing between the two groups in terms of change of~     Cobb angle, truncal balance, health-related quality of life measures and their health-care~     costs at the set time-points, the investigators aim to gain insights of whether different~     brace-weaning protocol will be more beneficial and cost-effective in patients' clinical and~     quality of life measure outcomes.~   "
18115|NCT03329820|"~     The aim of the study is to assess the health-related quality of life (HRQOL) and~     preference-based health utilities of chronic hepatitis B (CHB) carriers in different stages~     of illness. It will also estimate the cost-effectiveness of anti-viral treatments resulting~     from the prevention of the progression of disease from uncomplicated CHB carriers to~     cirrhosis and hepatocellular carcinoma (HCC).~      The following hypotheses will be tested:~        1. Patients with chronic hepatitis B virus (HBV) have poorer health-related quality of life~          (HRQOL) than the general population;~        2. Patients with more severe stages of chronic HB infections have lower health related~          quality of life and health utility values;~        3. Anti-viral treatment can improve the HRQOL and health utility for patients with CHB~          infections;~        4. The cost-effectiveness of different treatments for chronic HBV infections can be~          directly compared in terms of cost/QALY gained.~   "
18116|NCT03329807|"~     The aim of this research will be to investigate in stroke patients whether upper limb motor~     function can be maximized in response to sensory stimulation by comparing protocols for the~     application of Transcranial Magnetic Stimulation (rTMS) in the cortical region of S1 and~     Sensory Therapy in the upper limb paretic. Patients will be randomly and randomly allocated~     into four groups, Group 1 (G1) composed of individuals who will receive the protocol for the~     application of rTMS in the ipsilateral S1 cortex and fictitious sensory therapy in the~     paretic upper limb; Group 2 (G2) subjects will receive protocol of Sensory Therapy in the~     upper limb ethical and application of fictitious rTMS in the ipsilesional S1 cortex; Group 3~     (G3): application of the protocol of application of rTMS in the ipsilateral S1 cortex~     associated with Sensory Therapy in the upper limb paretic and, G4 (GSHAM) control group in~     which fictitious rTMS will be performed and fictitious Sensory Therapy in the paretic upper~     limb).~   "
18117|NCT03329781|"~     Chronic diseases such as diabetes, cardiovascular diseases and cancer are a major burden on~     the Scottish population. Obesity and inflammation have strong links to these diseases. One of~     the mechanisms explaining the relationship between low-grade inflammation and excess weight~     is endotoxaemia. We wish to study this phenomenon, when small components coming from our~     gut bacteria can pass into the bloodstream, raising the body's defences. Diet can modulate~     endotoxaemia. In this study, we propose to use curcumin, in a capsule form, to modulate~     endotoxaemia. Curcumin comes from turmeric, which is widely used as a spice. In this study,~     we want to test the effect of consuming curcumin extract to the composition of the gut~     microbiota, post-meal endotoxaemia, and inflammatory markers in blood.~   "
18118|NCT03329768|"~     A preliminary study was conducted from 01/26/2015 to 10/26/2015 on 605 patients admitted to~     MIA with an intravenous and/or a urinary catheter.~      the investigators analyzed:~        -  the demographic characteristics of the patient~        -  the final diagnosis~        -  the patient's severity and the patient outcome after discharge from MIA~        -  the justification of the venous and or a urinary catheter~        -  the duration of the prescription of the device Evaluation on admission of the need to~          maintain an intravenous or urinary catheter. Adjusting the prescription in terms of~          duration or withdrawal of the device in order to limit their complications~          (lymphangitis, superficial thrombophlebitis, bacteremia related to health care, urinary~          tract infection).~      Hypothesis:~      Limit the length of stay and reduce the cost of hospitalization.~   "
18119|NCT03329755|"~     This study compares the care pathway of melanoma patients treated by immunotherapy in two~     ambulatory care structures. The aim is to measure if a care structure specialized in~     immuno-oncology could rationalize the care of patients.~      This protocol will be based on two different follow-up during the treatment period:~        -  dedicated and coordinated e-follow-up (IUCT-O in Toulouse)~        -  standard follow-up (University Hospital Center in Bordeaux)~      Patients will be followed from the first cycle of immunotherapy until 3 months after the~     initiation treatment.~   "
18120|NCT03329742|"~     This is a single-center, randomized, open-label study to assess the feasibility of a~     low-protein diet intervention in patients with metastatic castrate-resistant prostate cancer~     (CRPC) who are receiving treatment with sipuleucel-T. Subjects will be randomized (1:1 ratio)~     to either Arm 1 or Arm 2 (Fig. 1).~      Arm 1: Subjects randomized to Arm 1 will be treated with sipuleucel-T infusion on Day 1,~     every two weeks for a total of three infusions. Subjects on this arm will receive a control~     diet containing 20% protein.~      Arm 2: Subjects randomized to Arm 2 will be treated with sipuleucel-T infusion on Day 1,~     every two weeks for a total of three infusions. Subjects on this arm will receive a~     low-protein diet containing 10% protein.~      Patients with metastatic, asymptomatic or minimally symptomatic CRPC that has progressed~     despite androgen deprivation therapy will be eligible for the study. After informed consent~     eligible patients will be scheduled to receive sipuleucel-T (three infusions two weeks apart)~     with normal-protein diet vs. low-protein diet. Each cycle will be every 14 days. Diet~     intervention will commence 1 week prior to the first apheresis (Day -7) and will continue~     until 10 days after the last infusion of sipuleucel-T (Day +42) (Fig. 2).~   "
18121|NCT03329729|"~     Dyslipidemias are a major risk factor for the onset of cardiovascular disease, while early~     diagnosis and appropriate treatment approaches significantly reduce cardiovascular morbidity~     and mortality.~      The aim is to provide revised Greek guidelines for the diagnosis and treatment of~     dyslipidaemias.~      The lipids of the human body are cholesterol (it is used to synthesize cell membranes,~     adrenal hormones and gonads and is a component of bile) and triglycerides (used as a fuel and~     as a storage of energy in adipose tissue). Dyslipidemias are disorders (quantitative or~     qualitative) of the metabolism of lipoprotein particles [low density lipoproteins (LDL),~     chylomic, high density lipoproteins (HDL), very low density lipoproteins (VLDL)] that carry~     lipids into the body.~      Primary prevention in subjects aged 40-65 years with no known clinical atherosclerotic~     disease and without diabetes or chronic renal disease should evaluate the likelihood of a~     fatal cardiovascular event over the next 10 years. For this purpose, it is recommended to use~     the Greek version of the SCORE of the Hellenic Heart SCORE.~   "
18160|NCT03329209|"~     The purpose of this study is to assess the PK of vedolizumab following a single IV infusion~     in healthy adult Chinese participants.~   "
18161|NCT03329196|"~     For Non-dialysis subjects with anemia associated with chronic kidney disease, demonstrate~     non-inferiority of MT-6548 compared to darbepoetin alfa using Hb value and evaluate long-term~     safety of MT-6548.~      For subjects not currently receiving ESAs, evaluate Hb correction and maintenance effect of~     MT-6548 and for subjects currently receiving ESAs, evaluate Hb conversion and maintenance~     effect of MT-6548~   "
18123|NCT03329703|"~     Developed by researchers from the Centers for Disease Control and Prevention (CDC), Project~     UPLIFT (Using Practice and Learning to Increase Favorable Thoughts) is a group telephone~     program designed to improve depression for people with epilepsy. Project UPLIFT uses~     evidence-based approaches of cognitive-behavioral therapy (CBT) and mindfulness-based~     cognitive therapy to help people manage and prevent symptoms of depression.~      For people with psychogenic non-epileptic seizures, there are few treatment options for~     depression that address the relationship between mood and seizures. There is evidence that~     mindfulness-based therapy and cognitive therapy are both effective for people with~     non-epileptic seizures, both in treating depression and reducing seizure frequency. In this~     study, Project UPLIFT will be offered to patients with psychogenic non-epileptic seizures.~      Project UPLIFT is facilitated by a trained clinician to groups of 4-8 patients over the~     telephone. The group will meet at a regular time, once a week, for 8 consecutive weeks.~     Participants will be assigned to one of two groups: an immediate-treatment or a waitlist~     control group which will begin Project UPLIFT 3 months after enrolling in the study.~   "
18124|NCT03329690|"~     The primary purpose of this trial is to compare the efficacy and safety of DS-8201a and~     physician's choice treatment in HER2-overexpressing advanced gastric or gastroesophageal~     junction adenocarcinoma patients who have progressed on two prior treatment regimens~     including fluoropyrimidine agent, platinum agent, and trastuzumab.~   "
18125|NCT03329677|"~     The purpose of the study is to examine the impact of an 18-month psychotherapy treatment for~     borderline personality disorder. The investigators will examine changes in psychosocial and~     work functioning in patients with borderline personality disorder using an 18-month~     psychotherapeutic treatment.~      The investigators are recruiting female patients between the ages of 18-35 who meet DSM~     criteria for BPD.~      The investigators are excluding patients who meet the following criteria:~        -  psychotic disorders~        -  a current major depressive episode~        -  bipolar I disorder~        -  current substance dependence~        -  antisocial personality disorder.~        -  unable to undergo 18-months of twice weekly psychotherapy in NYC~      Participants in the study will receive 18-months of twice weekly psychotherapy, free of~     charge, as well as compensation for follow-up assessments. They may be currently taking~     psychiatric medication.~      Participants will be assessed using semi-structured diagnostic interviews, self-report~     instruments, and computerized tasks in an initial assessment session lasting about 6-8 hours.~     They will also be assessed using computerized tasks during an MRI scan. Follow-up assessments~     will occur throughout the treatment as well as after the treatment, lasting about 1-4 hours.~     The investigators will also be collecting information on their treatment history and~     psychiatric medication as part of the study.~   "
18126|NCT03329664|"~     This study aims to evaluate the safety and efficacy of activated and expanded autologous~     cytokine-killer cells in controlling disease recurrence in patients with colon cancer. 20~     patients with confirmed colon carcinoma who have had complete resection of primary lesions~     will be randomly assigned into two groups. Patients in both groups will receive the same~     therapeutic regimen as usual. Patients in one group additionally will be treated with several~     infusions of autologous killer cells that had been previously prepared from peripheral blood.~   "
18127|NCT03329651|"~     Physical activity is a first line treatment for patients with type 2 diabetes (T2D), however,~     the vast majority of patients with T2D do not achieve satisfying glycemic control with~     physical activity alone, which is why pharmacological treatment with metformin is most often~     initiated.~      It is known that metformin and exercise both activates 5' adenosine monophosphate-activated~     protein kinase (AMPK) in skeletal muscle and liver, and the activation of AMPK results in~     many different metabolic effects, including improvements in glycemic control. Because of this~     similarity in mechanism of action, an interaction between metformin and exercise is~     plausible, but knowledge in the area is sparse. Thus, the aim of this study is to assess the~     effects of acute physical activity with and without concomitant metformin treatment, in order~     to investigate whether an interaction between the two occur.~      Subjects with impaired glucose tolerance will be randomized (1:1) to metformin/placebo~     treatment in a double-blinded way. Following a treatment run-in period of 17 days, two~     experimental days (one with acute exercise and one without acute exercise), separated by one~     week, will be performed in each subject.~      This registration concerns a sub-study of another study which has previously been registrered~     at ClinicalTrials.gov (Unique Protocol ID: H-17012307). The specific outcomes in this~     registration have not previously been registered.~   "
18128|NCT03329638|"~     To investigate the safety and efficacy of three concentrations of DE-127 ophthalmic solution~     when compared to Placebo in subjects diagnosed with mild or moderate myopia.~      To investigate the dose response of DE-127.~   "
18129|NCT03329625|"~     A mixed methods randomized control trial was conducted to test the effectiveness of Pathways~     Triple P with child welfare involved families compared to treatment as usual. Outcomes tested~     included parenting behaviors and attitudes, and child behavior problems. 144 families were~     recruited into the study. Data was collected at 4 time points (baseline, 4 months, 9 months,~     and 18 months). Over 70% were retained from baseline to 18 months.~   "
18130|NCT03329612|"~     Remote ischemic preconditioning is a process of serial blood pressure cuff inflations and~     deflations that are performed prior to a procedure and have been shown in various other areas~     (coronary bypass surgery, vascular surgery, ST elevation myocardial infarctions) to decrease~     the rates of adverse events related to ischemic burden and renal injury. This procedure has~     not yet been studied in the population presenting with an acute coronary syndrome (ACS), even~     though ACS patients represent the majority of patients seen in the catheterization lab. The~     purpose of this study is to evaluate the efficacy of this simple and safe procedure in this~     particular population.~   "
18162|NCT03329183|"~     This trial aims to evaluate the efficacy, safety of high-dose FOLFIRI regimen in advanced~     colorectal cancer patients with wild-type UGT1A1*6 and *28.~   "
18250|NCT03328039|"~     This is an observational, non-interventional study to assess the equivalence of wearable~     monitors with formal CPET testing for the prediction of physiological reserve before major~     surgery.~   "
18347|NCT03326778|"~     This is a prospctive, unrandomized multicentric registry which will enrol patients with an~     indication for aortc valve replacement combined with myocardial reperfusion (CABG). The~     registry will collect patient specific baseline data and established risk scores (Logistic~     Euroscore I & II, STS-Score, KBA Score) to enable us to make an estimate about the~     perioperative risks.~   "
18131|NCT03329599|"~     The overarching objective of the Stroke Minimization through Additive Anti-atherosclerotic~     Agents in Routine Treatment (SMAART) trial is to assess whether a polypill containing fixed~     doses of (2/3) antihypertensives, a statin and antiplatelet therapy taken once daily orally~     would result in carotid intimal thickness regression-a surrogate marker of atherosclerosis,~     improved adherence, and tolerability compared with 'usual care' group on separate individual~     secondary preventive medications among Ghanaian first time stroke survivors. Our ultimate~     objective is to design of a future multi center, double-blinded, placebo-controlled,~     parallel-group, randomized trial comparing the clinical efficacy of the polypill strategy vs~     'usual care' in the African context to derive locally relevant, high-quality evidence for~     routine deployment of polypill for CVD risk moderation among stroke survivors in LMICs. In~     this current study, we plan to recruit 120 recent ischemic stroke survivors randomized 1:1 to~     the polypill or usual care arms.~   "
18132|NCT03329586|"~     The investigators will investigate whether high-intensity exercise training can safely~     improve physical performance in long-term stable heart, kidney, lung, and liver transplant~     recipients. Adult transplant recipients will participate in Transplantoux, a 6-month~     individualized home- and group-based training program, with the goal to cycle the Mont~     Ventoux in France. The investigators will do cardiopulmonary exercise testing : maximal~     oxygen consumption, maximal power and BMI.~   "
18133|NCT03329573|"~     Paroxetine is a selective serotonin reuptake inhibitor (SSRI) and paroxetine IR tablets have~     been approved for the treatment of three anxiety indications in China. This bioequivalence~     study will evaluate Paroxetine IR tablets manufactured in GSKT (A) and Mississauga (B) sites~     in healthy Chinese subjects under fasting and fed conditions to support the quality~     consistency evaluation. This is a single dose, open-label, randomized, two-period crossover~     study and will include a screening period (up to 7 days), two open-label treatment periods~     (up to 16 days) and a follow-up phase (up to 14 days after last-dose). The whole study will~     be divided into two groups, one for fasting condition enrolling approximately 36 subjects and~     another for fed condition for which approximately 44 subjects will be enrolled. In both~     groups, eligible subjects will be randomized to receive single dose of Paroxetine IR tablets~     A or B in a cross-over manner.~   "
18134|NCT03329560|"~     The purpose of this study is to determine whether oral fecal microbiota transplantation (FMT)~     is safe for people with human immunodeficiency virus (HIV) infection.~   "
18135|NCT03329547|"~     Cefixime is an orally active third generation cephalosporin indicated for the treatment of~     acute exacerbations of chronic bronchitis, acute otitis media, uncomplicated acute cystitis~     and uncomplicated pyelonephritis. Cefixime acts by inhibiting the action of proteins involved~     in the synthesis of bacterial cell walls, which leads to bacterial cell lysis and cell death.~     Due to lack of bioequivalence between tablet/capsule and suspension formulation of cefixime,~     consideration needs to be given if the oral suspension is to be substituted for the~     tablet/capsule. This study is designed to assess whether test SKF101804 cefixime 400~     milligrams (mg) capsule is bioequivalent to reference cefixime 400 mg capsule under fasting~     conditions in healthy adults. Subjects will be randomized in crossover manner to receive~     single oral doses of treatment A (SKF101804 cefixime test capsules) and treatment B~     (reference cefixime capsules), followed by a washout period of 7-14 days. Approximately 26~     subjects will be included in the study and total duration in the study for each subject will~     be approximately 5 to 7 weeks.~   "
18136|NCT03329534|"~     In a small group of people gluten, a storage protein commonly in wheat and other grains, can~     cause gut inflammation and symptoms like diarrhea and abdominal pain. Gluten-related~     disorders include celiac disease (CD) and non-celiac gluten sensitivity (NCGS) and are~     treated by starting a gluten free diet (GFD). Patients with CD and NCGS also more commonly~     experience esophageal reflux and damage to the lining of the esophagus. A potential~     consequence of long-standing heartburn is Barrett's esophagus (BE), a major risk factor for~     cancer of the esophagus.~      This study aims to investigate the mechanism that leads to reflux and BE in those with gluten~     related disorders, and to assess if a GFD is beneficial. We will study the upper gut function~     and reflux activity in patients with BE both with and without a GRD disorder. Testing will~     occur before and after a gluten free diet is instituted. The results will help inform health~     care providers and patients about the connection between gluten-related disorders, reflux,~     BE, and the role of GFD.~   "
18137|NCT03329521|"~     Compared to dialysis, kidney transplantation is associated with improved survival, better~     quality of life and substantial cost savings to healthcare systems.Despite these advantages,~     many individuals with kidney failure never receive a kidney transplant. A multicomponent~     quality improvement initiative was developed to enhance access to kidney transplantation and~     living kidney donation in Ontario's chronic kidney disease (CKD) programs. These CKD programs~     provide care to individuals with reduced kidney function. The initiative includes four main~     components: Data (e.g., data collection and reports to CKD programs about their transplant~     related performance); 2. Education (e.g., education toolkits for CKD program staff, kidney~     patients and families, including living kidney donor candidates); 3. Transplant Ambassadors~     (e.g., kidney transplant recipients and living kidney donors who discuss transplantation and~     living donation to patients and their families) and 4. Administration (e.g., provincial~     administrative support and resources provided to CKD programs to support local work). This~     trial will provide high-quality evidence about the effectiveness of a multicomponent quality~     improvement initiative aimed to enhance access to kidney transplantation and living kidney~     donation.~   "
18138|NCT03329508|"~     A Phase 3, Twelve-week, Multi-Center, Multinational, Randomized, Double-Blind, Double-Dummy,~     Parallel Group Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily~     Compared to its Individual Components in Subjects With Early Parkinson's Disease and to a~     Calibration Arm of Pramipexole ER.~   "
18139|NCT03329495|"~     A randomized controlled clinical trial to compare the outcomes of SMA- and SMV- orientated~     laparoscopic right hemicoloectomy for right colon cancer with a medial-to-lateral approach~   "
18187|NCT03328858|"~     The purpose of this study is to evaluate the effect of the ketogenic diet on tumor size and~     quality of life in pediatric patients with malignant or recurrent/refractory brain tumors.~   "
18188|NCT03328845|"~     This study evaluates in a group of people with DM 1 the influence in parameters of oxidative~     stress of the treatments with the different current analogs of insulin~   "
18140|NCT03329482|"~     Back pain is one of humanity most frequent complains. About nine of ten adults experience~     back pain at some points in their life and five out of ten working adults have back pain~     every year. When continued for long period it may constitute a disability which tries the~     patient of the most stoical individual as well as the doctor called to bring relief to the~     suffering victim.~      Kneading massage with topical analgesic is a common practice by physiotherapist especially in~     Nigeria in the management of low back pain, work has been done to know the efficacy of lofnac~     gel (topical analgesic) via phonophoresis in the management of low back pain(ojoawo,2015),~     but the comparison of the efficacy of kneading massage and phonophoresis in the management of~     low back pain has not been well documented. The purpose of this study therefore, is to~     compare the efficacy of kneading massage and phonophoresis using lofnac gel in the treatment~     of non-specific chronic low back pain.~   "
18141|NCT03329469|"~     Coronary Computed Tomography Angiogram (CCTA) is a non-invasive imaging modality that has~     high sensitivity and negative predictive value for the detection of coronary artery disease~     (CAD). The main limitations of CCTA are its poor specificity and positive predictive value,~     as well as its inherent lack of physiologically relevant data on hemodynamic significance of~     coronary stenosis, a data that is provided either by non-invasive stress tests such as~     myocardial perfusion imaging (MPI) or invasively by measurement of the Fractional Flow~     Reserve (FFR). Recent advances in computational fluid dynamic techniques applied to standard~     CCTA are now emerging as powerful tools for virtual measurement of FFR from CCTA imaging~     (CT-FFR). These techniques correlate well with invasively measured FFR [1-4]. The primary~     purpose of this study is to evaluate the incremental benefit CT-FFR as compared to CCTA in~     triaging chest pain patients in emergency settings who are found to have obstructive CAD upon~     CCTA (generally >= 30% stenosis). Invasive FFR and short term clinical outcomes (90 days)~     will be correlated with each diagnostic modality in order to evaluate positive and negative~     predictive value of each.~      Patients will undergo a CCTA, as part of routine emergency care. If the patient consents to~     participate in the study, the CCTA study will be assessed by Toshiba Software, to provide a~     computerized FFR reading, based on the CCTA study. If the noninvasive FFR diagnosis indicates~     obstructive disease, the patient will undergo cardiac catheterization with invasive FFR.~      As CCTA utilization increases, the need to train additional imaging specialists will~     increase. This study will assess the capability of FFR-CT to enhance performance on both~     negative and positive predictive value for less experienced readers by providing feedback~     based on CT-FFR evaluation. If the use of CT-FFR improves accuracy of CCTA, as compared to~     the gold standard, (Invasive FFR), use of CT-FFR can potentially enhance performance for less~     experienced readers.~   "
18142|NCT03329456|"~     The investigators have recently shown that LSIB in combination with a suprascapular and a~     cervical plexus block is a very good alternative for arthroscopic shoulder surgery. However,~     the investigators believe the total volume of local anesthetic for LSIB may be reduced. For~     shoulder surgery there is no need to block the medial cord and the investigators therefore~     hypothesize a significantly lower MEV95% by applying a selective lateral and posterior cord~     block~   "
18143|NCT03329443|"~     an interventional study to measure the possible effects of spironolactone ( an aldosterone~     antagonist) on the incidence of acute kidney injury after coronary angiography~   "
18144|NCT03329430|"~     The purpose of the research is to compare the influence of customized foot orthoses use on~     the venous status among healthy female and male subjects. This is a quasi-experimental study~     which included 20 healthy subjects. Sociodemographic and medical record data are registered.~     Furthermore,venous function is evaluated by plethysmography, first, without orthoses and,~     after 20 days, with orthoses.~   "
18145|NCT03329417|"~     In the proposed study, the investigators assumed that mirror therapy combined with virtual~     reality technology will provide a better treatment effects than traditional mirror therapy~     for the patients with unilateral stroke. The aim of the study is to examine the difference in~     the treatment effects among the combination of task-oriented training with either virtual~     reality based mirror therapy, mirror therapy or traditional occupational therapy on the upper~     extremity function and brain activity of the stroke patients.~   "
18146|NCT03329404|"~     This is a prospective, multi-center, randomized, crossover trial to evaluate the clinical~     effectiveness of red blood cells (RBCs) derived from Mirasol-treated whole blood (WB) versus~     conventional RBCs in transfusion dependent thalassemia patients. Throughout the clinical~     study, RBC transfusion volume and frequency will be determined by each subject's treating~     physician.~   "
18147|NCT03329391|"~     Pharmacotherapy and psychotherapy, effective management strategies for treatment-resistant~     depression are limited and yet to be developed. However, nursing interventions focusing on~     adherence enhancement, symptom reduction, and stress management may be strategic for a better~     disease management. This study aims to define the rarely-studied concept of TRD under the~     cultural context of Taiwan and to identify new feasible treatment model from nursing~     perspectives. The project will establish important basis on the descriptions of psychosocial~     features and need assessment of people with TRD under experienced psychiatric team~     validation, and also build up a cultural-specific non-pharmacological intervention module for~     effective TRD management in Taiwan. The nursing model of TRD management will promote the~     development of integrative depression care in the future and complement current modalities,~     while providing important evidence-based information for further research and services.~   "
18148|NCT03329378|"~     Primary Objective:~      • Determination of pathologic complete response (pCR) rates~      Secondary Objective:~        -  Determination of cardiac toxicity as measured by: composite of LVEF, longitudinal strain~          and troponin.~        -  Breast conservation rates~        -  Overall survival~      Study Design~        -  Approximately 34-74 patients with Her2 positive, Stage II-regional IV breast cancer will~          be enrolled.~        -  Patients will be stratified by ER/PR status.~        -  They will be randomized to ddACTHP vs TCHP.~             -  Initially, 17 patients will be randomly assigned to each treatment arm.~             -  If 3 or fewer patients have a pCR, then that arm will be terminated and no further~               patients will be entered on that treatment arm.~             -  If 4 or more patients obtain a pCR, 20 additional patients (total of 37 patients)~               will be randomized to that treatment arm.~             -  If 11 or more patients out of 37 have a pCR, the treatment will be of interest for~               further study.~   "
18149|NCT03329365|"~     Paroxysmal nocturnal hemoglobinuria (PNH) is a rare acquired clonal hematological disorder,~     which can cause arterial or venous thrombosis. The frequency of PNH in young patients (< 50~     years old) with embolic stroke (ESUS), transient ischemic attack (ETUS) or superior sagittal~     sinus cerebral venous thrombosis (SSS-CVTUS) of undetermined source, is currently unknown.~     This study proposes to recruit ESUS, ETUS, SSS-CVTUS patients to determine the frequency of~     PNH diagnosis confirmed by flow cytometry in these patient populations.~   "
18359|NCT03326622|"~     This study evaluated the influence of a tailored aerobic exercise protocol on the functional~     outcome in ALS patients. In addition, the investigators compare some CPET variables collected~     during exercise testing in both groups.~   "
18150|NCT03329339|"~     Background 2L polyethylene glycol plus ascorbic acid (PEGA) is known to be as effective as~     standard 4L polyethylene glycol for bowel preparation. However, the volume of this regimen is~     still large. Therefore, the present investigators evaluated the potential of 1L PEGA with~     prepackaged low-residue diet (PLD) for an alternative to 2L PEGA.~      Aim: To evaluate efficacy of 1L PEG with ascorbic acid combined with prepackaged low-residue~     diet as bowel preparation for colonoscopy.~      Methods: The subjects were randomly assigned to either groups. PEGA group received 2L PEGA~     split regimen. PLD group received PLD on the day preceding colonoscopy and 1L PEGA on the~     morning of colonoscopy. One blinded physician performed colonoscopy and evaluated the degree~     of bowel preparation using Boston bowel preparation score (BBPS). A questionnaire regarding~     tolerability and safety were also gathered.~   "
18151|NCT03329326|"~     Background and rational:~      A large number of instruments exists to assess upper limb prosthetic function. However, they~     differ substantially in terms of psychometric properties and content. Furthermore, there is~     no gold standard and nearly every single center uses a unique set of instruments. This fact~     prevents the linking of the commonly small (due to the limited number of patients in each~     center) data sets of different centers and makes comparisons between different fittings or~     treatment protocols difficult. To generate accepted evidence, we need large data sets with~     similar outcomes. With remarkable progress made in prosthetic research and rehabilitation in~     the recent years, the need to evaluate the impact of this intervention on daily life,~     including productivity, self-care and leisure becomes increasingly relevant. Moreover,~     self-reported instruments and observation-based instruments exist, but there is a lack of~     data if, for example, the self-reported instrument (which is easier and less~     health-professional's-time-consuming to perform) could replace a performance or~     observation-based instrument.~      Therefore, the aim of this study is to determine psychometric properties of the existing~     instruments (SHAP, DASH, SF-36 and ACMC) in a large international data set, to explore~     possible linkage between self-reported and performance or observation-based instruments and~     to develop state-of-the art recommendations/points to consider on how to assess functioning~     in prosthetic care.~   "
18152|NCT03329313|"~     Intermittent hemodialysis/diafiltration is a current renal replacement therapy (RRT)~     institued for ICU patients with AKI. For a better clinical tolerance, iinternational~     guidelines advise to use cold dialysate, increase duration session, decrease blood and~     dialysate flows, and increase level of sodium dialysate concentration (≥ 145mmol/l). Indeed,~     the use of a Na concentration dialysate > 145 mmol/l improves intradialytic hemodynamic~     tolerance but it may also induce fluid overload by the transfert of sodium from the dialysate~     compartment to the blood. Yet, fluid overload has been strongly associated with mortality in~     critically ills. The investigators hypothesized that the use of a level in sodium dialysate~     at 140 mmol/l with slow low efficiency daily dialysis-filtration (SLEDD-f) will permit a fair~     intradialytic hemodynamic tolerance without the adverse effect of intradiaclytic Na loading~     from the dialysate. Two randomized groups of ICU AKI patients treated by SLEDD-f will be~     compared in terms of intradialytic hemodynamic tolerance and overload accordong to 140 or 145~     mmol/l of Na in the dialysate~   "
18153|NCT03329300|"~     We plan to examine whether child and parental cognitive/executive function predict body~     composition outcomes and adherence to a 6-month protocol of Family-Based Behavioral Treatment~     (FBT), for pediatric obesity. Our objectives are to: (1) examine the effects of parent and~     child complex cognitive functions on treatment outcomes and adherence in a 6-month FBT~     program for obesity in a diverse group of children aged 8-12 (total of 16 child-parent~     pairs), and (2) examine the strength of the relationship between parent and child cognitive~     function. We hypothesize that children with poorer executive function, and those who have~     parents with poorer executive function, will have poorer body composition and adherence~     outcomes.~   "
18154|NCT03329287|"~     This trial attempts to evaluate the treatment efficacy of Simplified Cognitive Behavioral~     Therapy (SCBT) and its safety among schizophrenia patients. Half of participants will be~     randomized to accept SCBT.~   "
18155|NCT03329274|"~     The investigators want to understand more about what kinds of health problems are caused by~     Erdheim-Chester Disease (ECD), what happens as a result of different treatments for ECD, and~     how ECD affects people's lives, their feelings and their attitudes. The investigators also~     want to learn how these things change over time for people with ECD. To try to figure this~     out, doctors would like to collect information about people who have ECD and how they are~     treated for this disease.~   "
18156|NCT03329261|"~     Acute Coronary Syndrome (ACS) is triggered by the rupture of an atherosclerotic plaque that~     results in a platelet aggregation reaction in the coronary artery. The administration of~     antiplatelet agents starting from the acute phase of the disease has helped reduce the risk~     of ischemic relapse both during initial and long-term hospitalization.~      Management of clopidogrel following an ischemic event has been the subject of several~     treatment regimens ranging from a single continuous dose to a sequential double dose of~     between 7 and 30 days. The CURRENT-OASIS 7 therapeutic trial showed a benefit of clopidogrel~     double dose in reducing the risk of myocardial intervention (MI) and the composite outcome:~     cardiovascular mortality, MI, or stroke (CVA/TIA) at 30 days. However, the study protocol was~     interested in all ACSs, regardless of the Type 2 Diabetes Mellitus (T2DM) status in selected~     patients. Also, doubling of clopidogrel dose was maintained over 7 days after angioplasty.~     The literature describes an increased cardiovascular risk in type II diabetics in secondary~     prevention. No previous study has evaluated the effect of clopidogrel double dose given for 1~     month on the reduction of this risk in the long-term in diabetic patients.~      Thus, the objective of this study is to evaluate the efficacy and safety of clopidogrel~     double dose, given for 1 month in ACS in the diabetic patient.~   "
18157|NCT03329248|"~     This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination~     therapy in subjects with pancreatic cancer who have progressed on or after previous SoC~     chemotherapy. Phase 2 will be based on Simon's two-stage optimal design.~   "
18158|NCT03329235|"~     The aim of this study was to compare the efficacy of treatment in three groups of patients~     with knee osteoarthritis (OA) given a combination of intraosseous with intra-articular~     injection of platelet rich plasma (PRP), intra-articular injection of PRP and a single~     application of hyaluronic acid (HA).~   "
18159|NCT03329222|"~     A randomised, double blind, controlled, multi-centre study to assess the efficacy of an~     infant formula in the dietary management of infantile colic.~   "
18163|NCT03329170|"~     Background: Congenital heart disease (CHD) is one of the most common congenital anomalies in~     children. As the risk for endocarditis following bacteraemia is more common during daily oral~     hygiene routines, such as tooth brushing, than during dental treatment, the maintenance of~     optimal oral health in children with CHD may be considered of outmost importance. Children~     with CHD have a higher caries prevalence compared to healthy controls.~      Aim: The primary aim of the study is to explore if an educational intervention including~     information, counselling and support provided at early stage to families affected by major~     CHD, or CHD combined with a syndrome, can increase the awareness of the importance of~     maintaining of good oral health, and avoid the development of poor oral health including~     dental caries, leading to less dental anxiety and a higher oral heath related quality of~     life. The secondary aim is to elucidate factors associated with the development of poor oral~     health and/or orofacial dysfunction as well as family attitudes and needs of support.~      Hypothesis: Early information, counselling and support will lead to a) increased awareness of~     the importance to maintaining good oral health, b) prevent the development of poor oral~     health and dental caries, c) lead to less dental fear, and d) lead to higher oral heath~     related quality of life.~      Study design: Randomized educational intervention trial. Study population: Children born in~     Finland and under 12 months of age in 1.7.2017-31.12.2021 with, a) major CHD and potentially~     included in the criteria of endocarditis prophylaxis, or b) with a major CHD combined with a~     chromosomal syndrome, will be offered to participate in the study. Patients will be recruited~     until 200 patients are obtained at the Helsinki University Children's Hospital. A control~     group consisting of approximately 100 healthy children will also be recruited at birth.~      Main outcomes: Dental caries, dental anxiety, oral health related quality of life, and~     awareness of importance to maintain and behaviour to maintain good oral health.~      Significance: Better information to patients leads to better possibility to achieve good oral~     health. Better oral health leads to 1) less dental procedures and thereby less dental~     anxiety, 2) less dental procedures under general anaesthesia, which may potentially be a risk~     procedure for the child with CHD, and 3) better oral health related quality of life.~   "
18164|NCT03329157|"~     Pilot study on an intervention called Rebuilding Bridges to help veterans re-engaged with~     loved ones.~   "
18165|NCT03329144|"~     Approximately 1 in 4 adolescent mothers will develop depression after delivering a child,~     though some studies suggest that as many as 53% will develop postpartum depression. A~     frequent accompanying symptom is emotion dysregulation which not only adversely affects their~     mental well-being, but jeopardizes their parenting and their child's health. Unfortunately~     significant barriers exist for young mothers, preventing access to treatment. This study will~     pilot the feasibility of having public health nurses deliver this 9-session program within a~     curriculum for teen mothers.~   "
18166|NCT03329131|"~     To determine rate and severity of chemotherapy induced neuropathy in extremities treated with~     cold gloves and socks versus control extremities~   "
18167|NCT03329118|"~     the purpose of thr study is to investigate the potential interation between multiple oral~     doses of SHR3824 and single oral dose of Simvastatin in healthy adult volunteers.~   "
18168|NCT03329105|"~     This study evaluates the addition of a mouth rinse containing sea salt, xylitol and lysozyme~     to standardized oral health practices on biofilm formation and gingival health in a group of~     young adults.~   "
18169|NCT03329092|"~     A Phase 3 comparative study to determine the efficacy, safety and tolerability of~     Aztreonam-Avibactam (ATM-AVI) ± Metronidazole (MTZ) versus Meropenem (MER) ± Colistin (COL)~     for the treatment of serious infections due to Gram negative bacteria.~   "
18170|NCT03329079|"~     Overweight and obese men in rural Northeast Nebraska are an unrepresented, at-risk group~     exhibiting rising rates of cardiovascular disease, poor access to preventive care, and a~     rural milieu that contributes to their sedentary physical activity and unhealthy diet. This~     study proposes to use a pragmatic randomized controlled trial and community engaged research~     approaches to 1) determine the feasibility and acceptability of a smart phone self-monitoring~     app (Lose-It Premium) plus text-based coaching and daily weighing via Wi-Fi scale~     intervention for achieving weight loss, 2) determine preliminary efficacy of this~     intervention group to a comparison group receiving only a self-monitoring app (Lose-It Basic)~     in achieving the outcomes of weight loss (kilogram) and improved dietary and physical~     activity behaviors (secondary) at 3 and 6 months post-baseline, and 3) determine quantitative~     and qualitative indicators of community capacity to support a contextually relevant weight~     loss intervention. Eighty men (ages 40-65) with body mass index of 28-45, randomly assigned~     (1:1 ratio) to intervention group or comparison group. Men will complete baseline assessments~     (weight, % body fat, body mass index height, blood pressure, health history, dietary intake,~     physical activity frequency/intensity) and receive orientation to the mobile technologies~     (Lose-It app features, text messaging, Wi-Fi scale). Men will track their dietary intake,~     physical activity, and weight on the Lose-It app for 12 weeks. After the 3-month~     intervention, post-measure assessments (weight, % body fat, BMI, dietary intake, PA~     frequency/intensity, technology usability surveys) will be collected at 3 and 6 months~     post-baseline. At 6 months post-baseline, two groups (n=8 each) of intervention completers~     will be purposively selected to share their perceptions of the intervention efficacy in an~     evaluative focus group. A community advisory board comprising local leaders within the men's~     social network, together with investigators and rural student nurses will guide community~     outreach efforts for study recruitment, implementation and evaluation. Study findings will be~     evaluated with the community to inform local dissemination, future intervention revision, and~     determination of community capacity for support of a larger clinical trial.~   "
18171|NCT03329066|"~     The overall goal of this project is to develop and to preliminarily validate a novel~     intervention to be delivered in the high school setting that integrates two evidence-based,~     school-based interventions for urban adolescents with proven efficacy: (1) Asthma~     Self-Management for Adolescents (ASMA), an intervention for adolescents with uncontrolled~     asthma and (2) the Sleep-Smart Program (Sleep-Smart), which focuses on sleep hygiene and~     behaviors in urban adolescents.~      The aim for Phase I is to develop and integrate school-based interventions to improve asthma~     self-management and sleep hygiene in urban high school students via interviews.~      The aims for Phase II are: (1) to evaluate the feasibility and acceptability of the~     intervention procedures; and (2) to assess the preliminary evidence of the effects of the~     intervention on improving sleep quality in urban high school students with persistent asthma~     over a 2-month follow-up period.~      This record is for Phase II only.~   "
18172|NCT03329053|"~     The aims of this trial are:~      (A) to determine and compare the indices of exercise recommendations compliance after~     exercise prescription according to digital training and decision support system as compared~     to exercise prescription following the standard informative procedure among patients with~     cardiovascular disease.~      (B) to determine whether health literacy moderates effect of exercise prescription according~     to digital training and decision support system on the indices of exercise recommendations~     compliance among patients with cardiovascular disease.~   "
18173|NCT03329040|"~     Neonatal hyperbilirubinemia elongates hospital stay and may require treatment. The~     investigators noticed that bilirubin levels were higher among infants of primipara mothers~     than among multipara mothers. As this data is dichotomic and easy to produce, and may~     influence the maintenance, the investigators decided to find out if primiparity is a risk~     factor for neonatal hyperbilirubinemia. The investigators intend to collect data from patient~     files during one year, and compare the bilirubin levels and length of stay between newborns~     to primipara mothers and multipara mothers.~   "
18189|NCT03328832|"~     Our purpose of this study therefore is to conduct a prospective randomized controlled trial~     to investigate the blood-conservation effect of combined topical application of these two~     hemostatic agents in different time during surgery and the safety compared with single~     topical application of TKA in a primary TKA procedure~   "
18174|NCT03329027|"~     The study is a prospective, adaptive, multicenter, randomized, double-blind, Sham-controlled~     pilot study, to evaluate the efficacy and safety of the Vibrant Capsule in relieving~     constipation in subjects with functional constipation.~      Three arms will be assessed:~        -  Vibrant Capsule with vibrating mode 1 administered 5 times per week~        -  Vibrant Capsule with vibrating mode 2 administered 5 times per week~        -  Sham Capsule administered 5 times per week~      Subjects will be followed continuously for at least a 2 weeks run-in period and then be~     randomized to either Vibrant or Sham capsules for a treatment period of 8 weeks. The first 2~     weeks of treatment will be considered as a subjects' training period.~      Data reporting will be done on an electronic Case Report Form and an eDiary. Subjects will be~     asked to refrain from taking any medication or supplement to relieve their constipation,~     during the entire study period.~      After the run-in period, the subjects will return and eligibility will be re-assessed.~     Subjects will be trained on how to use the base unit and will swallow the first capsule on~     site the day of baseline visit. They will activate and ingest the rest of the capsules at~     home by themselves, using the base unit.~      Subjects will be instructed to complete a simple subject eDiary each day throughout the~     duration of the study. A final visit will take place at the end of the 8 week treatment~     period.~      Subjects will receive phone calls at least once a week and subject compliance will be~     monitored during the 8 weeks of the study.~   "
18175|NCT03329014|"~     A prospective dose escalation, nine period cross-over trial assessing the safety,~     pharmacokinetics, bioavailability and pharmacodynamics of escalating doses of Remimazolam~     when administered intranasally as powder and solution in healthy subjects and compared to an~     intravenous control~   "
18176|NCT03329001|"~     This is a two stage, open label, randomized-sequence, single-crossover Phase 1 study to~     evaluate the relative bioavailability (BA) of niraparib administered as a tablet formulation~     compared to the reference capsule formulation currently marketed in the United States.~     Specifically, a 300 mg niraparib tablet will be compared to 3 niraparib capsules (3 × 100~     mg).The Extension Phase of this study is to enable patients enrolled in the study to continue~     to receive treatment with niraparib tablets if they are tolerating it and, in the~     Investigator's opinion, may receive benefit.~   "
18177|NCT03328988|"~     There are ca 1000 new cases of bladder cancer in Finland/year. The curative therapy for high~     risk bladder cancer is radical cystectomy. The golden standard is still an open surgery~     despite development of laparoscopic techniques. Epidural analgesia is considered as most~     effective for the treatment of postoperative pain. However, there is a need for other~     effective options, because epidural analgesia has some contraindications and risks for~     serious complications. Recently quadratus lumborum block has gained popularity in the~     treatment of postoperative pain after various surgeries in the area from hip to mamilla. It~     is more beneficial than other peripheral blocks, since it covers also the visceral nerves.~     Contrary to the need of epidural catether a single shot QLB has reported to last up to 48~     hours.~      Inadequately treated acute postoperative pain is considered as one of the main risk factors~     for persistent postoperative pain.~      44 patients aging 18-85 will be recruited based on a power calculation. The primary outcome~     measure is the acute postoperative need for rescue analgesics. Secondary outcomes are acute~     pain (NRS scale), nausea, vomiting, mobilisation and longterm outcomes such as quality of~     life and persistent pain.~   "
18178|NCT03328975|"~     The overall purpose of this study is to evaluate the effect of a corticosteroid shoulder~     injection on glucose levels in insulin-dependent diabetic men and women.~   "
18179|NCT03328962|"~     The intervention to be studied is a smoking cessation program offered to newly diagnosed~     cancer patients at their first consultation for treatment at an oncological hospital~     department.~   "
18180|NCT03328949|"~     The objective of this post market study is to examine the safety and performance of the~     Shockwave Coronary Intravascular Lithotripsy System for the treatment of narrowed coronary~     arteries before the doctor places a stent.~   "
18181|NCT03328936|"~     This randomized phase II trial studies the side effects and how well melphalan hydrochloride~     works in treating patients with multiple myeloma that has come back or does not respond to~     treatment. Drugs used in chemotherapy, such as melphalan hydrochloride, work in different~     ways to stop the growth of cancer cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading.~   "
18182|NCT03328923|"~     The current study will explore the impact of seaweed extract on cognitive function following~     a high-carbohydrate meal at a number of time-points post-consumption.~   "
18183|NCT03328910|"~     Surgical plethysmography index (SPI) is a device that can noninvasively monitor the balance~     between the nociception and ant-nociception using pulse photoplethysmographic amplitude~     (PPGA) and heart rate obtained through an oxygen saturation measuring device. SPI has~     recently been studied as a useful tool to monitor the stress response of patients due to~     surgery or anesthesia and to guide the appropriate use of analgesics/anesthetics. However,~     these SPI devices have been developed for adults and have not been studied in pediatric~     patients with relatively high heart rates, and no direct effects on post-operative arousal~     excitability have been reported.~   "
18184|NCT03328897|"~     The purpose of this study is to demonstrate the efficacy and safety of omalizumab, compared~     with placebo, as an add-on to H1AH therapy in adult patients suffering from CSU who remain~     symptomatic despite H1AH therapy. The results of this study will support registration of~     omalizumab for adult patients suffering from CSU in China, and potentially in other~     countries.~   "
18185|NCT03328884|"~     Multicenter open-label, phase II trial, to evaluate the efficacy and safety of nal-IRI in~     patients with HER2-negative breast cancer, who have documented Central Nervous System (CNS)~     progression following Whole Brain Radio Therapy (WBRT), Stereotactic Radiosurgery (SRS)~     and/or surgery, as determined by the Response Assessment in Neuro-Oncology Brain Metastases~     (RANO-BM) criteria.~   "
18186|NCT03328871|"~     Nowadays, multiple treatment modalities have been applied clinically to treat striae~     gravidarum, such as laser therapy, microdermabrasion, platelet-rich plasma injection(PRP),~     etc. To some extent, these treatments can improve striae gravidarum. In this clinical trial,~     the investigators are going to treat striae gravidarum by using two different kinds of~     combination therapies. One is fractional laser and PRP injection synergy, and the other one~     is treated by nanofat grafting with PRP injection.~   "
18190|NCT03328819|"~     Objectives: The effect of acupuncture as treatment for chronic pain and depression~     comorbidity is questionable because only a limited number of controlled clinical trials with~     sound methodologies have been conducted. The investigators will perform a well-designed~     crossover study including assessments of scales and blood sample analysis to investigate the~     efficacy of acupuncture as treatment for comorbidity of chronic pain and major depression~     disorder (MDD) and figure out the indicative biomarkers to predict or assess the comorbidity.~      Methods: Patients with a recent major depression and chronic pain were randomized to receive~     acupuncture for depression group or acupuncture for chronic pain. They will receive 2~3~     sessions per week over 6 consecutive weeks. Then patients accept another 6weeks sessions~     after two-week washout. During washout period, original western treatment will be maintained~     and acupuncture will be interrupted.~      The primary outcome measure was change in 21-item Hamilton Depression Rating Scale (HAMD),~     pain with Brief Pain Inventory- Long form (BPI). Secondary outcome measures included changes~     in Beck Depression Inventory-II (BDI-II), Neurotoxicity Rating Scale (NTRS), WHO Quality of~     Life (WHOQoL), Clinical Global Impression (CGI), biomarkers such as neurotransmitter, kinase,~     protein, cytokine, DNA, mRNA related to comorbidity of chronic pain and major depression.~   "
18191|NCT03328806|"~     This study aims at translating, cross culturally adapting and establishing the psychometric~     properties of the The Core Outcome Measure Index (COMI) for patients with low back pain (LBP)~     in Egypt. This study will be conducted at the outpatient clinic of public hospitals in Egypt.~      This study will be divided into two main stages: (1) Translation and cross culture~     adaptation, and (2) Validation.~      In the translation and cross culture adaptation stage, the original English version will be~     translated into modern Arabic following the guidelines described by Beaton et al. (2000).~     Then, the translated final version will be tested on a sample of 30-40 participants in a~     small pilot study to ensure linguistic clarity.~      For the validation stage, 100 male and female adults with LBP will be recruited from public~     physiotherapy outpatient clinics. Eligible patients will be asked to complete a questionnaire~     booklet containing The Arabic versions of Oswestry Disability index (ODI), Ronald Morris~     Disability Questionnaire (RMDQ), Short-form 36 (SF-36) and the Visual analogy scale (VAS).~      Further, disability and function will be assessed by Timed Up and Go test (TUG), 50 feet~     walking and loaded reach test.~      Outcome measures will include:~        1. Face validity which will be evaluated subjectively based on judgment of expert committee~          and patients' feedback.~        2. Concurrent validity is assessed by testing correlation between the COMI and VAS, ODI,~          RMDQ and SF-36~        3. Construct validity will be assessed by testing the correlation between the scores for~          each item of the COMI and its corresponding valid back specific full-length~          questionnaire including the ODI, RMDQ, SF-36 and VAS.~      All testing procedure will be repeated after seven days for testing reliability.~   "
18192|NCT03328793|"~     Music has a potential role in health care. In the geriatric population, music presents a~     non-pharmacological intervention which is easy to implement. Also, music has a potential role~     in order to improve patient's mobility. For example, it was also shown that the rhythmic~     component of music combined with physical exercise can improve gait variability which has~     been identified as a marker of gait instability and a fall predictor. This effect was~     previously shown in older community dwellers as a music-based intervention significantly~     improved gait and balance stability.~      Considering that music was shown to have a positive impact on communication, emotions and~     depressive symptoms this intervention has the potential to make our patients more conscious~     of their environment, leading to an improved mobility.~      Thus, the investigators hypothesize that patients who attend live music sessions (compared to~     controls) will demonstrate an improvement in their mobility measures. This effect could~     potentially be explained by the rhythmic effect of music and by the fact that live music~     sessions lead to an improved mood, communication, emotions, and an improved mobility.~        -  The primary objective of this study will be to determine if participation to live music~          sessions will be associated with an improvement in mobility which will be measured using~          the Times Up and Go (TUG) and gait speed when compared to a control group.~        -  The second objective of this study will be to determine if patients participating in~          live music sessions compared to a control group demonstrate an increase/improvement at~          the end of their music session in their mood (the Visual Analog Mood Scale (VAMS) will~          be used), in their positive emotions (the Observed Emotion Rating Scale (OERS) will be~          used) and communication behaviour (the CODEM (tool to assess communication behavior in~          dementia) instrument will be used).~        -  The third objective of this study will be to perform a feasibility study. By measuring~          the variation in the different scales which will be used (see the third objective), the~          investigators will be able to determine how many participants will be necessary for an~          eventual larger scale study.~      This will be a prospective open-label randomized control trial. The patients will be randomly~     assigned to a musical intervention or to a television intervention (control group). The~     patients will only attend one session in the context of this research project. Pre and post~     measures will be done.~   "
18193|NCT03328780|"~     Anemia prevalence in orthopedic surgery is up to 30 %. Identifying those patients prior to~     surgery and treating them would be ideal. Different ways of determining hemoglobin Levels are~     available. In this study classical laboratory determination, determination with HemoCue® and~     Rad-67™ will be performed to compare precision of those three methods as well as their~     correlation.~   "
18194|NCT03328767|"~     Critically ill patients who require extracorporeal membrane oxygenation (ECMO) are the~     sickest in the hospital. More patients are surviving but survivors have compromised~     functional recovery for months or years. This trial aims to determine if early, physical~     training commenced within 48 hours of ECMO is feasible and improves muscle strength and~     functional status in patients compared to standard practice in a randomised controlled trial~     of 30 ICU patients.~   "
18195|NCT03328754|"~     The objective of this 2-arm parallel double blinded randomized controlled trial is was to~     evaluate and compare the treatment effects of PowerScope and Forsus in the treatment of Class~     II division 1 malocclusion. Patient comfort and operator convenience was also assessed and~     compared .~   "
18196|NCT03328741|"~     This study will compare the effects of a novel web-based program (Joint Academy) to regular~     face-to-face treatment (the BOA program) for people with osteoarthritis of the knee. Half of~     the participants will be randomized to the web-based program whilst the other half will~     receive regular face-to-face care.~   "
18197|NCT03328728|"~     This is a non-inferiority study on 190 patients to evaluate whether a treatment based on the~     combination of autologous platelet-rich plasma and hyaluronic acid obtained with Cellular~     Matrix represents a therapeutic advantage to relieve symptoms associated with a mild to~     moderate knee osteoarthritis (particularly pain on walking) compared to hyaluronic acid only~     (Synvisc®-One).~   "
18198|NCT03328715|"~     Patients will be examined before and after surgery with a stand-alone OCT and intraoperative~     microscope integrated OCT~   "
18199|NCT03328702|"~     Investigator initiated prospective study to determine whether use of Continuous Positive~     Airway Pressure (CPAP) can improve the swallow function in patients who underwent total~     laryngectomy and are experiencing difficulty swallowing~   "
24140|NCT03250988|"~     The purpose of this study is to improve spasticity diagnosis through exploration of potential~     new diagnostic markers for spasticity that can assist in diagnosis and referral.~   "
18201|NCT03328676|"~     The most common syndrome in patients with severe dementia is agitated behavior, which is~     often characterized by a combination of violent behavior (physical or verbal), restlessness,~     and inappropriate loudness. The treatment options for this syndrome are limited and lead to~     severe side effects. In vivo experiments on animals and clinical studies on adults show that~     cannabinoids could have a beneficial effect on behavioral disorders in general, and in~     dementia-related disorders in particular.~      Additionally, medical cannabis patients have reported that cannabis aids in pain relief,~     increased appetite, and a sense of calm and peace of mind. Elderly patients suffering from~     dementia that experience this syndrome could also benefit from other quality of life aspects~     of the cannabis treatment such as reduction in medication consumption, weight gain and~     improvement of sleep.~   "
18202|NCT03328663|"~     This research study is evaluating the impact of a psychological intervention on the quality~     of life and mood of caregivers of patients undergoing stem cell transplant.~   "
18203|NCT03328650|"~     The purpose of this study is to document the performance and clinical outcomes of the~     A.L.P.S® Proximal Humerus Plating System.~      The optional, interventional arm of this study will assess bone quality in the proximal~     humerus of a fracture patient population.~      Specific Aims:~        -  Conduct physical assessments measuring shoulder strength and range of motion, physician~          assessment of radiographs~        -  Obtain patient-reported outcomes regarding pain level, function capabilities, and~          work/leisure restrictions~        -  Document revisions, complications, and adverse events~      The optional, interventional arm of this study will assess bone quality in the proximal~     humerus of a fracture patient population. DXA is not particularly effective at identifying~     individuals who are at risk of suffering a fracture. Yet, there is a growing population of~     diabetics and elderly individuals prone to fragility fractures. In effect, the age-related~     and diabetes-related increase in fracture risk is independent of a person's aBMD. These~     findings stress the urgency in developing diagnostic tools that can improve fracture risk~     prediction so that patients can be treated with the appropriate anti-fracture therapies.~      Shifting from the current paradigm of using X-ray based modalities to assess fracture risk,~     the reference point indentation (RPI) method acquires direct measurements of 'materal~     quality' of the bone tissue. Specifically, the OsteoProbe-RPI engages the patient's bone, and~     upon applying an impact force, it measures the ability of the tissue to resist~     micro-indentation. Despite the encouraging results from aformentioned studies applying RPI to~     bone, there is no evidence that a local measurement of bone material quality are predictive~     of fracture resistance at sites that are prone to fragility fractures (e.g. the proximal~     humerus).~      By affirming the ability of RPI to discriminate a fragility fracture from a high-energy~     (trauma) fracture of otherwise normal bone, the data from this optional study arm may provide~     justification for large prospective studies that evaluate whether intra-operative RPI is~     useful for surgical guidance.~   "
18204|NCT03328637|"~     The use of Smartphone has been adopted faster than any other device in the history of digital~     electronics. Hence it is estimated that in 2016, 2.1 billion were found registered Smartphone~     users in the world and Pakistan was ranked 10th in the list of top 10 countries with largest~     number of mobile phone subscribers. Despite of its useful and timely utilization, the~     excessive use of Smartphone coerce the Individual to be dependent on the use of Smartphone~     psychologically and even physically. Furthermore, among the users, adolescents and young~     adults used Smartphone (90%) more than any other age groups. Moreover, this prevalence is~     expected to rise in the future due to the easy availability and swift changes and addition of~     new applications to Smartphone technology. Subsequently, the excessive and irrational use of~     Smartphone leads to Smartphone addiction which impact on individual mental health, physical~     health, and disrupt social, economic and educational functions. So, this study aims to assess~     the effectiveness of Cognitive Behavioral Therapy (CBT) as an evidence based remedy in the~     treatment of Smartphone addiction. The study will comprise of two groups; one will receive~     CBT (intervention group) and the other one will be on Treatment As Usual (TAU). The aim of~     the study is to assess the effectiveness of CBT primarily by measuring the addictive~     smartphone usage assessed by Smart Phone Addiction Scale (SAS) and also on secondary outcomes~     including time management, academic performance and social functioning of adolescents. These~     assessments will be conducted before intervention (on the baseline assessment sessions),~     during the Intervention and after the intervention (on follow up assessment sessions). A~     total of 120 students were calculated on the basis of 80% statistical power required to~     detect the effect as indicated by previous study and will be selected from different~     educational institutions. SPSS 23.0 will be used for data analysis. The primary analysis will~     be mixed ANOVA to compare the between group and within group means differences on measures~     used in the study. Multiple Hierarchical Regression analysis will also be used for the~     prediction of outcome variables from the demographics. The total duration of the study is one~     year.~      This study primarily aims to assess the effectiveness of Cognitive Behavioral Therapy (CBT)~     as an evidence based remedy in the treatment for Smartphone addiction. The basic purpose is~     to minimize the severity of Smartphone addiction up to manageable level. Furthermore, there~     are certain psychiatric symptoms that are found to be associated with the addictive usage of~     Smartphone like stress, depression, anxiety, hyperactivity, attention deficits and conduct~     problems. The study design will also allow to assess the effectiveness of CBT on such~     outcomes: (a) The depression, anxiety and stress level of the participants (b) The time~     management of the participants (c) The emotional symptoms, conduct problems, hyperactivity~     and attention deficit problems, peer relationship problems and pro-social behavior aspects of~     the participants (d) The satisfaction level of the participants.~   "
18205|NCT03328624|"~     A preliminary clinical usability study to assess design, comfort, wearability, and acceptance~     of Recovery Force's Deep vein thrombosis (DVT) cuff~   "
18206|NCT03328611|"~     The purpose of this research study is to develop a database of information regarding the~     diagnosis, treatment, and outcome of participants who have had a joint replacement. The more~     information gathered, the better the investigators will be able to treat future patients who~     need a joint replacement. For example the investigators learn what works well to help design~     implants and treatment protocols for the future. The investigators publish manuscripts and~     present research findings around the world to help other investigators and clinicians learn~     what is discovered. Furthermore, implant manufacturers may be able to use this information in~     the database to evaluate the success rates of specific joint replacement products.~   "
18207|NCT03328598|"~     This is a community-based participatory research aiming at helping the only-child loss~     parents to be happier and resilient from bereavement. It is a psycho-behavioral intervention~     research. There are two intervention programs in this study. One is derived from a foreign~     psychotherapy, developed by an American psychologist and has been testified the effectiveness~     in promoting happiness. Another one is developed by the researchers based on the previous~     cross-sectional survey and interviews with those bereaved parents. The researchers will apply~     randomized controlled trial to testify and compare those two intervention programs in a~     Chinese community.~   "
18208|NCT03328585|"~     Cognitive behavioral therapy for insomnia (CBT-I) has been the 'gold standard' for the~     treatment of insomnia. There is a need to increase access to treatment, particularly for~     patients in more rural locations where providers may be scarce. One solution is to utilize~     telemedicine which is the use of electronic communications to provide and support health~     care when distance separates the provider from the patient. So the purpose of the study is~     to determine if receiving CBT-I by video teleconferencing works just as well as in-person~     treatment.~   "
18251|NCT03328026|"~     This is an open-label rollover study of Study WRI-GEV-007, which evaluates SV-BR-1-GM in~     metastatic or locally recurrent breast cancer patients. Patients who demonstrate progressive~     disease on Study WRI-GEV-007 will be eligible to enroll in this study, which will evaluate~     SV-BR-1-GM in combination with pembrolizumab (Keytruda) if their tumors express PD-L1 or~     PD-L2, or in combination with ipilimumab (Yervoy) if their tumors do not express PD-L1 or~     PD-L2. Treatment cycles will be every 3 weeks with evaluations for tumor progression or~     response every 8-12 weeks.~   "
24187|NCT03250377|"~     The purpose of the study is to evaluate the long-term safety and tolerability of BRV in focal~     epilepsy subjects with partial seizures and to evaluate the maintenance of efficacy of BRV~     over time.~   "
18209|NCT03328572|"~     1. RATIONALE All-ceramic endocrowns are bonded to the tooth using adhesive resins creating~          strong bonds to the tooth structure resulting in strengthening effect and reducing the~          need for post and core. various CAD/CAM materials can be used for the fabrication of~          endocrowns including lithium-disilicate reinforced glass-ceramics, feldspathic ceramics,~          in ceram alumina and in ceram spinell as well as hybrid ceramics and composites.~           Fewer data are available on the clinical performance of the different materials used for~          endocrowns. With the rapid innovation in the dental restorative materials clinicians are~          sometimes confused when selecting the best restorative material to restore an~          endodontically treated tooth with an endocrown. This is due to lack of data with regard~          to clinical performance of these restorations as well as the degree of patient~          satisfaction.~        2. OBJECTIVES P= Endodontically treated teeth indicated for endocrown I1= Feldspathic~          endocrown I2= Hybrid endocrown C= IPS e.max Endocrown O= Clinical performance~      Research question In patients with endodontically treated teeth requiring endocrown~     restorations, what are the clinical performance and the level of patient satisfaction of~     cerasmart endocrown versus lithium disilicate (e-max) ceramic endocrowns?~   "
18210|NCT03328559|"~     The pronostic value of Circulating Tumoral Cells(CTC) 's dosage by the method ISET® (tumoral~     cell isolation by size) in patients with bronchial cancer was previously demonstrated.~      However, no kinetic study was ever realized to study the value of the CTC as predictive~     indicator of answer to the therapy. This project plans to study patients in an early stage~     and patients at advance stage locally moved forward or metastatic of the disease by~     evaluation of the presence and the number of CTC before every cure. This collaborative and~     original study should allow to refine the diagnoses of answer and to plan the possible~     relapses what would allow a premature institution of the treatment.~   "
18211|NCT03328546|"~     To study, prospectively, the association between dietary patterns and risk of health outcomes~     (cardiovascular, metabolic, endocrine, neurological, skeletal muscular, cancer) in cohort~     study of 116,671 women age 24 to 44 years at baseline in 1989 (the Nurses' Health Study II;~     NHS II).~   "
18212|NCT03328533|"~     Comparison will be conducted between continuous variable infusions of both drugs~     (Phenylephrine and Norepinephrine) with starting doses of 0.75 mcg/Kg/min and 0.1 mcg/Kg/min~     respectively for prophylaxis against Post-spinal hypotension during cesarean delivery~   "
18213|NCT03328520|"~     The purpose of this study is to explore the efficacy and feasibility of an integrated,~     prescriptive, and trackable wellness intervention combining five wellness elements including~     exercise, mindfulness, sleep, social connectedness, and nutrition in First Year Beloit~     College students self-selected into a wellness focused first year initiative. This program is~     called WILD 5 Wellness: A 30-Day Intervention.~   "
18214|NCT03328507|"~     The objective of this study is to evaluate the safety and efficacy of BLI4900 as a bowel~     preparation prior to colonoscopy in adult patients.~   "
18215|NCT03328494|"~     This study will be conducted to assess the safety and tolerability of BOS172722 when~     administered as monotherapy and in combination with paclitaxel in participants with advanced~     nonhaematologic malignancies and also to establish the maximum tolerated dose and recommended~     Phase 2 dose of BOS172722 in combination with paclitaxel in those participants.~   "
18216|NCT03328481|"~     This study aims to explore the feasibility of using loss-of-resistance technique for~     Quadratus Lumborum block (QLB). And to compare between the Ultrasound guided QLB type II and~     the loss-of-resistance technique for QLB as regards the degree and duration of analgesia and~     side effects.~   "
18217|NCT03328468|"~     For the breathing intervention, the patients will be randomized into four groups (see figure~     below) to evaluate whether the order of when the breathing intervention occurs matters~     (respectively before or after questions about their perception of movements are asked).~     (experimental design)~   "
18218|NCT03328455|"~     Aging impacts our unisensory perceptual abilities as well as our ability to correctly combine~     signals from multiple sensory modalities to obtain a coherent percept of external events.~     Elderly individuals show greater difficulty determining the temporal order of audiovisual~     events, and possess a broadened temporal binding window (TBW) during which stimuli from~     different modalities are likely to be integrated into a single perceptual entity. Recent~     studies demonstrate that the TBW can be reduced following multisensory perceptual learning,~     however, the mechanisms at work remain poorly understood. Using an adaptive training~     paradigm, the goal of this proposed project is to examine how multisensory temporal~     processing can be enhanced in the elderly. Specifically, the investigators will measure the~     effect of multisensory perceptual learning on audiovisual temporal functions and its transfer~     to unisensory temporal tasks. Combining behavioral and EEG measures, the investigators will~     assess whether multisensory perceptual learning in the elderly changes only within the~     unisensory processes or reflects additional cross-modal processes. Furthermore, the~     investigators will characterize socioeconomic and health-related factors that contribute to~     age-related deficiencies in multisensory temporal processing and identify potential training~     outcomes for elderly subpopulations that are at greater risk. This work will provide insights~     into the brain mechanisms underlying multisensory perception and learning in the elderly.~   "
18219|NCT03328442|"~     VISTA technique with PRF compared to MCAF technique with PRF to treat gingival recession~   "
18220|NCT03328429|"~     To compare intraoperative and postoperative outcomes of Bartholin marsupialisation versus~     cystectomy~   "
18221|NCT03328416|"~     The investigators' overarching goal is to investigate whether use of an augmented reality~     display system (utilized in addition to, not as a replacement to, conventional CT and MRI~     displays currently available in the procedure suite) streamlines the process of a procedure~     and/or provides ease of access to helpful pre-procedure and intra-procedure imaging~     information that would be more difficult and time-consuming to obtain with the conventional~     imaging display systems.~   "
18316|NCT03327181|"~     The short chain fatty acid (SCFA) metabolism has not been studied in subjects suffering from~     COPD. The purpose of this study is to compare the SCFA metabolism in COPD patients to healthy~     matched controls. This protocol is an extension of recent studies about protein digestion and~     absorption abnormalities in COPD patients. The investigators hypothesize that SCFA production~     might be lower in COPD patients than in healthy subjects.~   "
18222|NCT03328403|"~     Aim of Study:~        1. To develop a standardized patient selection criteria and imaging protocol for~          endovascular therapy in acute ischaemic stroke (AIS)~        2. To create a local efficacy and safety database for intra-arterial mechanical~          thrombectomy devices use~        3. To establish predictors for poor functional outcome despite successful recanalization~      Study Design:~      Prospective~      Subject and Site:~      100 acute ischaemic stroke patients with large vessel occlusion At Queen Mary and Ruttonjee~     Hospital, Hong Kong~      Duration of participation:~      2 years~      Entry Criteria:~      Subject must meet all inclusion criteria and none of the exclusion criteria~      Consent:~      Both English and Chinese versions of Informed consent are available and will be obtained from~     patient or his/her next of kin~   "
18223|NCT03328390|"~     Regional anesthesia of the abdomen significantly reduce postoperative pain, spare the~     systemic opioids and decrease postoperative nausea and vomiting. Multiple regional techniques~     can be performed at the neuro-axis (epidural), the nerve root (paravertebral) and the~     peripheral nerve (transversus abdominis plane).~      Quadratus lumborum (QL) block is an addition into the league of truncal nerve block~     techniques that has been found to provide analgesia for abdominal surgeries. Several case~     reports have shown that local anesthetic injection around the quadratus lumborum muscle is~     effective in providing pain relief after various abdominal operations and in patients with~     chronic pain.~      The study hypothesis is that quadratus lumborum block in single shot may be more superior to~     transversus abdominus plane block as regard intra-operative and the post-operative analgesia.~   "
18224|NCT03328377|"~     To investigate whether the composition of the gut microbiota is different in patients that~     develop delirium during critical illness as compared to patients who do not.~   "
18225|NCT03328364|"~     The purpose of this study is to provide real world data on treatment with enzalutamide in~     metastatic castration-resistant prostate cancer (mCRPC) patients.~      The primary purpose is to evaluate overall survival (OS) in mCRPC patients treated with~     enzalutamide who have previously undergone treatment with chemotherapy (docetaxel) (post~     chemo patients).~      This study will also evaluate treatment duration with enzalutamide in patients pre- and~     post-chemo.~   "
18226|NCT03328351|"~     Background & Purpose: Cervical radiculopathy is a neurological disorder, which commonly~     results because of nerve compression. There are different types of physical therapy~     interventions that are used for cervical radiculopathy. The evidence of effectiveness of~     manual therapy in cervical radiculopathy is still limited. Short-term hypoalgesic effects~     after manual therapy was found in different musculoskeletal conditions. However, the~     effectiveness of manual therapy in patients with cervical radiculopathy hasn't been~     investigated yet. Therefore, the aim of study is to examine the short-term effect of manual~     therapy (mobilization) on the sensory features in patients with chronic cervical~     radiculopathy.~   "
18227|NCT03328338|"~     Hereditary (familial) amyloidosis arising from the misfolding of a mutated or variant~     transthyretin, is the most frequent form of amyloid cardiomyopathy in the Caribbean basin.~     Affected organs invariably harbor extracellular amyloid deposits in the myocardium.~     Circulating or pre-fibrillar amyloidogenic proteins are implicated in the disruption of cell~     function. Our aim is to demonstrate that transthyretin mediated amyloid disease alter the~     mitochondrial function of cardiac cells.~   "
18228|NCT03328325|"~     The study will be designed as a prospective surveillance of the immune response to seasonal~     influenza vaccination in 240 healthy children and adults ages 9 and over. Study duration will~     be 5 years, with a participant duration of 6 months. Subjects will receive Fluarix (GSK)~     quadrivalent inactivated influenza vaccine, at a dose of not less than 15 ug of hemagglutinin~     (HA), by intramuscular injection in open label fashion on day 0. Blood draws will occur at~     baseline, day 7, 28 and 90. The primary objective of this study is to evaluate the~     relationship between first influenza A virus exposure (inferred by age), vaccine history, and~     baseline serum antibody and Memory B cell (MBC) specificity, and the magnitude and breadth of~     the subsequent B cell response to seasonal influenza vaccine in healthy adults and children.~   "
18229|NCT03328312|"~     Reversal of rocuronium-induced neuromuscular block by the combination of low-doses of~     neostigmine plus sugammadex decreases the cost of anesthetic medications, while maintaining~     efficacy of reversal in obese patients.~   "
18230|NCT03328299|"~     TAP-block has been shown to be a safe and effective postoperative analgesia method in a~     variety of general. Dexmedetomidine is a selective α2 agonist with 8 times more affinity for~     α2 adrenergic receptors compared to clonidine and possesses all the properties of α2 agonist~     without respiratory depression. Dexmedetomidine has been focus of interest for its broad~     spectrum (sedative, analgesic and anesthetic sparing) properties, making it a useful and safe~     adjunct in many clinical applications.~   "
18231|NCT03328286|"~     Young adults who do not successfully transition from compulsory education to upper secondary~     level are at increased risk of developing mental illness, as compared with their working~     peers. The causality is unclear: they are either unable to find a job due to a pre-existing~     mental illness, or their failure in finding a job has contributed to the mental illness.~      The Zurich University of Applied Sciences has developed an innovative intervention that~     includes psychotherapeutic support in a work integration programme. Recognising and treating~     mental illness early increases the chances of a successful transition to the labour market.~   "
18232|NCT03328273|"~     This study evaluates the safety of acalabrutinib and AZ6738 when taken in combination.~   "
18233|NCT03328260|"~     Aim to evaluate the efficacy of safety of newly developed, high intensity focused ultrasound~     device in women with symptomatic uterine leiomyoma~   "
18234|NCT03328247|"~     The ASICA study is looking at how the UK National Health Service (NHS) might use technology~     in the future to more effectively support people who have been treated for melanoma.~   "
18235|NCT03328234|"~     The investigators aimed to compare elective nodal irradiation versus involved field~     irradiation with or without concurrent chemotherapy and the addition of consolidation~     chemotherapy for patients with extensive lymphatic metastasis of esophageal cancer.~   "
18236|NCT03328221|"~     This study aims to explore autonomic cardiovascular regulation, through measures of heart~     rate variability (HRV), during different passive and active activities in patients with~     severe acquired brain injury and a low conscious state. Data from active rehabilitation will~     be compared with passive periods of rest as well as nightly variance during a continuous~     5-day period.~   "
18237|NCT03328208|"~     Objectives of this Phase I pilot trial are to provide data towards assessing and facilitating~     feasibility of a larger scale Phase II trial in which the effects of a calmative Comfort~     Talk® app can be unequivocally evaluated.~      Towards this goal we will pursue following outcome parameters for~      Phase I: Feasibility/acceptability assessment:~      Primary outcome parameter:~      • ability to obtain complete on-site data sets from at least 90% of patients enrolled (with~     at least 40% from patients in the app group and at least 40% from patients in the control~     group).~      Secondary outcome parameters:~        -  ability to enroll 60 patients by day 150 after initiation of recruitment in the clinic~          (=day 1)~        -  obtain 38 packages of filled out diary cards (at least 16 from patients in the app group~          and at least 16 from patients in the control group)~        -  90% of patients in app group listen to app ≥5 min~      Phase II preparation primary outcome parameter~      • anxiety at the end of the waiting room time~      Secondary outcome parameters~        -  pain the end of the waiting room time~        -  anxiety during treatment~        -  pain during treatment~        -  anxiety during 1 week after treatment~        -  pain during 1 week after treatment~        -  use of units of sedatives and analgesics during 1 week after treatment~        -  patient satisfaction~   "
18238|NCT03328195|"~     This study tests the effects of the Neuro RX Gamma on the cognitive and behavioral~     functioning of subjects with moderate-to-severe Alzheimer's Disease. The Neuro RX Gamma uses~     non-invasive near-infrared energy delivered to the brain in daily treatment sessions at home.~   "
18239|NCT03328182|"~     This study is designed to assess the acceptability and usability of a new Endotracheal Tube~     (ET) holding device for an orally intubated patient.~   "
18240|NCT03328169|"~     Women with breast cancer who report insomnia that started or worsened during breast cancer~     diagnosis and treatment will be enrolled in a group behavioral trial to one of two arms~     testing cognitive behavioral therapy for insomnia against a mindfulness-based therapy.~   "
18241|NCT03328156|"~     Erectile dysfunction is a common sexual problem affecting up to one-third of men throughout~     their life. It is now well recognized that risk factors for erectile dysfunction (ED) include~     the same risk factors as coronary artery disease, including smoking, dyslipidemia, diabetes,~     hypertension, lack of physical activity and obesity. We will investigate the effect of~     reperfusion strategies (primary angioplasty & therapeutic therapy) on the prevalence of~     erectile dysfunction after acute myocardial infarction. Erectile function will be evaluated~     using the international index of erectile function after 3 months of successful reperfusion~     treatment of acute myocardial infarction.~   "
18242|NCT03328143|"~     Awake craniotomy for tumor surgery allows for mapping of speech, motor and sensory function~     during tumor resection. Awake craniotomy is increasingly utilized as it has several~     advantages over a traditional general anesthetic technique. Though many patients tolerate~     awake cranial surgery well, recent studies found that roughly 30% of patients experience~     moderate to severe pain and anxiety, while 50% report moderate fear and 11% report severe~     fear. Therefore, alternative methods to mitigate pain, anxiety, and fear are needed. In this~     study, the investigators will employ lavender aromatherapy to reduce anxiety and improve the~     satisfaction with pain control.~   "
18243|NCT03328130|"~     The study is a Phase I/II, monocentric, open-label, dose-ranging safety and efficacy gene~     therapy intervention by subretinal administration of AAV2/5-hPDE6B. At least twelve patients~     18 years of age or older, within three consecutive cohorts of patients, will be recruited.~   "
18244|NCT03328117|"~     The study is a randomized, double-blind, placebo-controlled clinical study of imatinib (as~     mesilate) in healthy subjects exposed inhaled lipopolysaccharide. During the study, eight~     oral doses of imatinib, or placebo, will each be taken 12 hours apart, before subjects are~     exposed to nebulized lipopolysaccharide (LPS). Four hours after LPS exposure, a~     bronchoalveolar lavage (BAL) will be undertaken, and BAL fluid (BALF collected. Once study~     assessments are completed, a follow-up visit will be conducted approximately 7 days after the~     last dose of imatinib.~      The primary objective of the study is to investigate the effect of imatinib on LPS-induced~     pulmonary vascular dysfunction. The primary endpoints of this study are:~        1. Change in the number of neutrophils in BALF 6 hours after the LPS challenge in subjects~          exposed to imatinib compared with placebo.~        2. Change in concentration of total protein in BALF 6 hours after the LPS challenge in~          subjects exposed to imatinib compared with placebo~   "
18245|NCT03328104|"~     T- cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LLy) has an~     increase in proteins in a specific pathway called the mTOR pathway within the cancer cells.~     In cancer cells it can encourage untimely cell growth, cell production, and cell survival.~     Everolimus is an inhibitor of the mTOR pathway and can decrease the growth and survival of~     cancer cells. It also prevents communication within cells and stops proteins from being made~     that may contribute to leukemia. The main purpose of the study is to find the maximum~     tolerated dose of everolimus when used together with standard chemotherapy.~   "
18246|NCT03328091|"~     This randomized controlled trial aims to evaluate the impact of pre-test video education and~     post-test genetic counseling as compared to in-person pre-test genetic counseling in males~     with advanced prostate cancer.~   "
18247|NCT03328078|"~     This is a multi-center, open-label trial of orally administered CA-4948 monotherapy in adult~     patients with Relapsed or Refractory NHL. The trial will be conducted in 2 parts: an initial~     Dose Escalation Phase (Part A) of CA-4948 in patients with Relapsed or Refractory Non-Hodgkin~     Lymphoma, (RR NHL) and a Dose Expansion Phase (Part B) of CA-4948 in patients with RR NHL~     with and without myeloid differentiation primary response 88 (MYD88) mutations. During Part~     B, patients will be enrolled regardless of MYD88 mutation status.~   "
18248|NCT03328065|"~     Reflexion on the therapeutic strategies to implement in patients at the end of life is~     advancing rapidly in France. However, beyond the choices presented to patients, sometimes~     even the decision to carry on, to limit or to stop treatments is also questioned. This~     decision is subjective; it is influenced by the patient's representation system (emotions,~     beliefs, values, practices, etc). In addition, even though he or she is the focus of the~     decision, the patient is not alone; other actors, accompanying the patient, play an important~     role in the final decision making. These actors, namely the doctors and close relatives, are~     also influenced in their decision making. This coexistence of representation systems may~     interfere with objective indicators that help in decision making (functional, clinical and~     biological) or with the knowledge acquired by doctors in their training and may complicate~     the decision-making process.~   "
18252|NCT03328013|"~     In France, the vaccination coverage observed for HPV vaccination is low for a full-scale~     regimen, and has been falling since 2010. A high rate of HPV vaccination coverage has a~     significant epidemiological impact with a reduction in cervical cancer mortality.~      There is less data on vaccinated catch-up patients. In 2017, these patients are 25 years of~     age or older and carry out screening smears.~      The aim of this study is to demonstrate whether HPV catch-up vaccination results in a~     decrease in the abnormal smear rate compared to the rate in unvaccinated patients.~      If so, these data will help mobilize doctors to vaccinate patients against HPV, even in~     catching-up.~   "
18253|NCT03328000|"~     Estate vlue of CTU and MRU in evaluation of failed anastomotic urethroplasty for pelvic~     fracture urethral distraction defect injury[PFUDDI] combared to retrograde urethrography and~     voiding cysto-urethrography .~   "
18254|NCT03327987|"~     Although time from transplant has been a factor in vaccine response, there is limited data on~     immunizations that occur in the first post-transplant year, and there are no data that~     suggest influenza vaccination early post-transplant may have any adverse effects on the~     graft. It is suggested that early vaccinations may lead to reduced immunogenicity due to~     induction immunosuppression. However, not vaccinating patients may leave them vulnerable to~     influenza infection for a period of time. This study is designed to look at the~     immunogenicity and side effects of the standard of care influenza vaccine in patients between~     31 and 365 days post-transplant.~   "
18255|NCT03327974|"~     Depression is a frequent disease and a serious public health problem, of which suicide is the~     most severe complication. Its treatment is based on the introduction of antidepressant which~     not only proposes a significant delay in the relief of symptoms but also by the phenomenon of~     lifting of inhibition can increase the suicidal risk during the initiation phase. Therefore~     there is a major interest in proposing a monitoring of these dark and suicidal ideas,~     immediately after the implementation of such treatment as well as other symptoms of~     depression. Thus, we aim to identify the mechanisms underlying this increase in dark and~     suicidal ideas in this context.~   "
18256|NCT03327961|"~     The prospective study will investigate the clinical performance and long-term safety of~     scaffold implantation in a real world regional setting. The protocol includes two different~     networks. The first network includes all cath-labs in the Emilia-Romagna region (SHERPA). The~     second includes the centers partecipating into the MAGIC retrospective study. Both networks~     joined into the prospective SHERPA-MAGIC project. Investigators from both networks agreed in~     indications and strategy implanatation described by the protocol. In each center, after IRB~     approval, the patients will be enrolled according to established criteria.~   "
18257|NCT03327948|"~     The ARTISAN-SNM study is designed to evaluate the safety and effectiveness of the Axonics~     Sacral Neuromodulation System as an aid in the treatment of the symptoms of urinary urgency~     incontinence (UUI) in patients who have failed or could not tolerate more conservative~     treatments.~   "
18258|NCT03327935|"~     Surgery combined with malnutrition is associated with loss of muscle mass and leads to~     serious consequences for the surgical patient. A majority of surgical patients continue to~     lose weight after discharge. Nutritional risk screening has not been fully implemented at~     Landssjúkrahúsið - the National Hospital of the Faroe Islands and therefore the prevalence of~     patients at nutritional risk is unknown. The aim of this study is to examine whether an~     intervention with independent nutritional supplements or an intervention combining~     nutritional supplements and resistance training is more effective in preventing loss of~     muscle mass than standard care in surgical patients following discharge. Secondary outcomes~     are changes in body weight, quality of life, muscle strength and activities of daily living.~     Furthermore, we want to screen hospitalized surgical patients for nutritional risk in order~     to get an estimate of the prevalence of nutritional risk.~   "
18259|NCT03327922|"~     This study aims to investigate whether the spacing of the interrupted deep (subdermal)~     sutures affects surgical wound cosmesis on the trunk and extremities. In other words, the~     investigator would like to determine which of the following yields a more cosmetically~     appealing scar: many closely approximated subdermal sutures or fewer, more widely spaced~     subdermal sutures. The investigator wishes to compare the effects of one versus two~     centimeter spacing between sutures.~   "
18260|NCT03327909|"~     For patients with kidney failure requiring hemodialysis treatment, sometimes the blood~     pressure will drop too low during dialysis. In an effort to prevent that from occurring,~     patients are frequently told to skip doses of their blood pressure medications. However,~     whether this actually prevents blood pressure drops during dialysis, and whether it may cause~     more uncontrolled high blood pressure is unknown. TAKE-HOLD will study the effect of taking~     or holding blood pressure medication on blood pressure for patients on hemodialysis.~   "
18261|NCT03327896|"~     Healthcare providers are routinely being assessed for metrics designed to assess the quality~     of the care they deliver. There is growing consensus that these measurements, which typically~     assess the percentage of patients meeting a specific standard of care, should be adjusted for~     the clinical complexity of the providers. This study will assess whether adjusting for the~     social complexity of the patient panel adds significantly to adjustment for clinical~     complexity in explaining apparent differences in quality of care provided by Primary care~     providers and clinics.~   "
18262|NCT03327883|"~     Background:~      Bladder cancer is a common cancer in the U.S. Survival rates for metastatic bladder cancer~     have not gotten better for 15 years. Diagnosing and assessing the disease is important for~     treating it. The best way to tell what stage a cancer is in is computed tomography. This is~     also called CT. But it does not always give the best images of the bladder. Adding a test~     called positron emission tomography (PET) can help. Magnetic resonance imaging (MRI) is even~     better than CT for detecting bladder cancer. But it is not widely used.~      Some people with bladder cancer have already had MRI/PET and CT. Researchers want to study~     their records. They want to compare the different ways of assessing the disease.~      Objective:~      To evaluate the use of MRI/PET for diagnosing and treating metastatic bladder cancer.~      Eligibility:~      People 18 years and older who were in studies between 2013 and 2016~      Design:~      Researchers will study existing records. There will be no active participants.~      The records will have no data that could identify the participants. Data will be stored on~     secure computers.~      No study participants will be contacted without approval from a review board.~   "
18263|NCT03327870|"~     Background:~      A person s dental health depends on many factors. Some are social, economic, or behavioral.~     Some are environmental. People with Sj(SqrRoot)(Delta)gren s Syndrome have a change in the~     amount and quality of saliva. This may affect dental health. Researchers want to study the~     dental health needs of people with this and other salivary gland problems. They will compare~     these findings with healthy volunteers. This will help them improve health care for these~     groups of people.~      Objectives:~      To study dental health needs of people with salivary gland problems and healthy volunteers.~     To study the disparities in dental health between these groups.~      Eligibility:~      Adults 18 and older who were in a Sj(SqrRoot)(Delta)gren s Syndrome study~      Healthy volunteers the same age~      Design:~      Participants will take an online survey. It should take less than 30 minutes. They can skip~     any questions.~      They will be asked about dental health, general health, and well-being.~      Information in the survey will be kept secure.~   "
18264|NCT03327857|"~     To establish the pharmacokinetic, pharmacodynamic, safety and efficacy profiles of~     Neihulizumab in patients with steroid-refractory acute graft-versus-host disease(sr-aGvHD)~   "
18265|NCT03327844|"~     This study evaluates the efficacy of Antibiotic pastes or Calcium hydroxide disinfection on~     healing of periapical pathology and continued root development of infected non-vital immature~     permanent teeth in children.~      In the test group regenerative endodontic therapy (RET) is performed with antibiotics as the~     disinfecting agent, in the control group RET is performed with Calcium Hydroxide as the~     disinfecting agent.~   "
18266|NCT03327831|"~     Photodynamic therapy is an effective treatment for actinic keratoses. In the United States~     topical aminolevulinic acid (ALA) is approved as a photosensitizing agent for this treatment,~     and it has traditionally been activated with the use of an in-office artificial light source.~     This clinical trial seeks to measure the safety and efficacy of using natural sunlight to~     activate the ALA.~   "
18267|NCT03327818|"~     AIM OF THE WORK The aim of the study is to compare the maternal morbidity and mortality~     between obstetric hysterectomy and conservative surgery for pregnant ladies > 28 weeks with~     placenta accreta during caesarean section at Ain Shams University Maternity Hospital in the~     last five years and prospective study in the next six months.~      Hypothesis In women with placenta accrete undergoing hysterectomy may be similar to~     conservative surgery as regard maternal morbidity and mortality.~   "
18268|NCT03327805|"~     Trimethylamine-N-oxide (TMAO), a metabolite produced by gut microbial metabolism of dietary~     choline, has recently been causally linked to atherosclerosis in animal models and has been~     shown to be predictive of cardiovascular disease (CVD) risk in some but not all cohort~     studies. The relevance of observations in animals to humans is unclear and little information~     is available on the mechanisms linking TMAO to increased CVD risk. Vascular dysfunction plays~     a critical role in the initiation and progression of atherothrombotic disease. Whether TMAO~     impairs vascular function in humans is not known. The purpose of this study is to determine~     if acute supplementation of dietary choline, which increases TMAO, impairs vascular function.~   "
18269|NCT03327792|"~     The purpose of this alcohol-interaction pilot study is to provide information on the effect~     of mavoglurant on the pharmacokinetics of alcohol and on alcohol responses, including~     stimulation, sedation, intoxication, body sway and physiological responses. The investigators~     propose to test the effects of 200 mg mavoglurant versus placebo on alcohol related~     responses. This is a between subjects double blind randomized design in which the~     investigators plan to run 14 subjects to obtain 10 completers.~   "
18270|NCT03327779|"~     The WBDR is an international observational disease registry of patients with hemophilia. It~     will provide a platform for a network of hemophilia treatment centres (HTCs) around the world~     to collect uniform and standardized patient data and guide clinical practice. With informed~     consent from the patient, the WBDR stores anonymous data about the person's disease, such as~     hemophilia type and severity, symptoms, and treatment.~   "
18271|NCT03327766|"~     Assesment of Vit D3 leve in cases of unexplained recurrent pregnancy loss in assiut~   "
18272|NCT03327753|"~     Dr. Macedo and others involved in the proposed research recently conducted a study that~     investigated whether simple clinical characteristics could identify patients who benefit more~     from either motor control exercises or graded activity. Results were statistically~     significant and clinically relevant demonstrating that a simple questionnaire could help aid~     the selection of the most appropriate exercise therapy for each individual patient.~     Therefore, we aim to conduct a randomized controlled trial following a similar approach to~     the original study to validate in a different sample the results of the effect modification~     analysis.~   "
18273|NCT03327740|"~     Dolutegravir (DTG) is recommended for both treatment-naïve and treatment-experienced, HIV~     infected adults and paediatric subjects aged 12 years and older and weighing at least 40 kg.~     One case of suspected DTG hypersensitivity (HSR) reaction from among over 1500 subjects~     exposed to the drug at the time of submission in 4Q2012, has been identified; this subject~     experienced a diffuse maculopapular rash with fever and elevated liver enzymes. Isolated rash~     was uncommon in the DTG programme with less than 1% of clinical trial subjects experiencing~     treatment related rash. The pharmacovigilance strategy for DTG and DTG-containing products is~     to implement a post-marketing risk management program to further quantify the risk of HSR and~     compare it to that of other integrase inhibitors, and to possibly determine associated risk~     factors. In addition, the post-authorization safety study will monitor and compare~     hepatotoxicity and severe skin rash following initiation of DTG or other integrase inhibitor~     (raltegravir (RAL) or elvitegravir (EGV) based antiretroviral regimens (ARV). Further to be~     able to distinguish the above symptoms and reactions caused by DTG or the other integrase~     inhibitor regimen from that of abacavir (ABC), known to cause hypersensitivity reaction, the~     integrase inhibitor groups will be compared in combinations with and without ABC. This five~     year-long safety study will be conducted through collaboration with EuroSIDA, a well~     established prospective observational cohort study of more than 18,200 subjects followed in~     107 hospitals in 31 European countries, plus Israel and Argentina. This is a five year-long~     non-interventional prospective cohort study nested within the EuroSIDA study. The study~     population will include HIV positive subjects over the age of 16 years from EuroSIDA clinical~     sites, who are new users of DTG or other integrase inhibitors with and without ABC. Following~     initiation of DTG with ABC based antiretroviral regimen or DTG without ABC or regimens~     containing other integrase inhibitors (RAL, EGV) with or without ABC or any other DTG based~     ARV regimen as monotherapy or two-drug regimens, the study will aim to a) Monitor and compare~     hypersensitivity reaction, b) Monitor and compare hepatotoxicity, and c) Monitor and compare~     severe skin rash among all subjects discontinuing DTG or other integrase inhibitor regimens~     for any reason.~   "
18274|NCT03327727|"~     The purpose of the trial is to evaluate the safety and efficacy of a new antifungal with a~     novel mechanism of action in immunocompromised adults with invasive aspergillosis.~   "
18371|NCT03326466|"~     In this case-control study, the investigators compare shoulder muscle function, pain, and~     central nervous system sensitization in patients with Subacromial Pain (SAP) to that in~     healthy controls. The investigators also examine if a relationship exists between shoulder~     symptom duration and central sensitization, shoulder muscle function and shoulder pain~     distribution in patients with SAP.~   "
18275|NCT03327714|"~     This study evaluates the short and long-term effect of 5-10 minutes daily mindfulness and~     compassion training in school among children aged between 6-16 years old. The mindfulness~     intervention will last for 10 weeks and the results will be compared to children who do not~     perform mindfulness in school. Due to practical reasons, the study is not randomized; classes~     are instead placed in the mindfulness or control group. Anxiety, mental, physical and social~     health, quality of life, and school performance will be evaluated via questionnaires and~     school registries, before and after the intervention and thereafter once a year until the end~     of ninth grade (age 16 years). Long term health (diagnoses, medical consumption, and drug~     prescriptions) and family income (proxy for socioeconomic status) will be followed in~     regional and national registries until 25 years of age.~      The hypothesis of the study is that mindfulness can prevent mental disorders and anxiety, and~     increase well-being in children and adolescents. The primary aim is to subsequently evaluate~     if regular, daily, mindfulness and compassion training (5-10 minutes) prevents anxiety and~     mental disorders in children and adolescents. Secondary aims are to evaluate 1) the effect of~     mindfulness on daily life, quality of life, and health in school pupils; 2) the effect of~     mindfulness on school performance; 3) the effect of mindfulness and compassion on the class~     room environment; 4) the effect of potential individual, family, and school-level risk~     factors on mental health in children and adolescents; 5) the effect of mindfulness on these~     potential risk factors.~      Sessions are led by school teachers who have been educated in mindfulness. Their own levels~     of stress and mindfulness will be evaluated by a questionnaire and compared to teachers in~     control classes both before and after the intervention. The teachers will also be interviewed~     to evaluate the effect of mindfulness on the class room environment.~      In a sub-study, the effect of mindfulness on brain structure and function will be examined by~     magnetic resonance imaging in school pupils aged 15-16 year old. This will be preceded by a~     pilot study, in which feasibility of the method is tested in the target group.~      To achieve sufficient statistical power, taking into account a cluster effect to adjust for~     grouping of the pupils, 1750 children and adolescents will be recruited. Written informed~     consent is a prerequisite for participation.~   "
18276|NCT03327701|"~     Severe asthma affects 5-10% of more than 300 million asthmatics. Ten to twenty percent of~     individuals suffering from asthma do not respond well to current treatment due to the~     complexity of the different mechanisms underlying asthma pathogenesis, and sometimes due to~     an insufficient effect of treatment on underlying airway inflammation. Consequently, some~     asthmatics have poorer quality of life due to: frequent asthma symptoms, regular medical or~     emergency visits, limitation in their activities of daily living, including exercise. It is~     believed that the benralizumab can help to reduce airway inflammation and thus improve~     exercise tolerance in individuals with asthma. The main objective of this study is to~     determine the effect of benralizumab on exercise-induced bronchoconstriction (EIB) and~     exercise tolerance in moderate to severe eosinophilic asthmatics, in comparison with baseline~     values and a placebo treatment.~   "
18277|NCT03327688|"~     This study has two aims.~        1. Deep venous thrombosis (DVT) is a common suspected medical condition. If it cannot be~          excluded clinically and using D-dimer, ultrasound examination is required. An option for~          traditional radiologist-performed ultrasound is a 2-point compression ultrasound~          (2-CUS). The safety of this technique is proven. However there does not exist any data~          on costs comparing traditional and 2-CUS pathways in primary health care. This study~          will evaluate the total cost of both pathways by conducting a cost-minimization~          analysis. It will also study the effect of a simple ultrasound education on the~          referrals to hospital due to suspected DVT.~           Hypothesis 1: Short education in ultrasound will reduce significantly referrals to~          hospital and save resources.~        2. Length of stay (LOS) in emergency department (ED) is related to increased mortality,~          morbidity, prolonged hospital stay and probably patient satisfaction. LOS of patients~          with a point-of-care ultrasound (POCUS) performed by an emergency physician (EP) will be~          compared to those that have a radiology performed ultrasound examination. Further~          examination and accuracy of POCUS will be noted.~      Hypothesis 2: POCUS can shorten LOS significantly in selected clinical conditions~   "
18278|NCT03327675|"~     This is an Investigator Initiated, non-commercial, single center, non-randomized, single arm,~     open label pilot study on 194 patients. The patients are affected by prostate cancer but in~     two different clinical settings. The first group is characterized by patients who are going~     to be operated of radical prostatectomy and they will undergo the study imaging~     preoperatively. The second group experiences biochemical relapse after primary treatment.~   "
18279|NCT03327662|"~     CTC-STOP is a multicentre prospective randomised controlled phase III trial for metastatic~     castration-resistant prostate cancer patients.~      This study will determine if serial CTC counts can be used as early markers of progression to~     direct early discontinuation of docetaxel chemotherapy in patients with mCRPC without~     adversely impacting overall survival, when compared with standard approaches to guide~     treatment switch decisions.~   "
18280|NCT03327649|"~     Heart failure with preserved ejection fraction (HFpEF) is a leading cause of mortality in the~     elderly. Outcomes of patients with HFpEF are poor and so far, no treatment has been shown to~     decrease morbidity or mortality. Recent animal and human studies suggest that a systemic~     proinflammatory state, produced by comorbidities, including aging, plays a central role in~     the development of HFpEF, supporting the notion that attenuating the proinflammatory state is~     an attractive therapeutic target for HFpEF. We have previously shown that low-level~     transcutaneous electrical stimulation of the vagus nerve (tVNS) suppresses inflammation in~     patients with atrial fibrillation. The overall objective of this proposal is to examine the~     effects of tVNS on diastolic dysfunction, exercise capacity and inflammation in patients with~     HFpEF. Our specific aims include: 1. To examine the effect of intermittent (1 hour daily for~     3 months) tVNS on diastolic dysfunction and exercise capacity, relative to sham stimulation,~     in patients with HFpEF and 2. To examine the effect of intermittent (1 hour daily for 3~     months) LLTS on inflammatory cytokines relative to sham stimulation, in patients with HFpEF.~     The proposed proof-of-concept studies will provide the basis for the design of further human~     studies using LLTS among populations with HFpEF. In light of the increasing number of elderly~     patients with HFpEF and the poor success of the currently available treatment options, an~     alternative and novel approach such as tVNS has the potential to impact clinical practice and~     improve health outcomes among a large number of patients. It is anticipated that these~     investigations will contribute to the broader understanding of the role of inflammation in~     the pathogenesis of HFpEF and how its inhibition can be used to provide therapeutic effects.~     Moreover, it is anticipated that a better understanding of how modulation of inflammation~     affects one of the hallmarks of HFpEF, diastolic dysfunction, will lead to the development of~     novel pharmacological and non-pharmacological approaches to treat this disease.~   "
18281|NCT03327636|"~     Papillary thyroid microcarcinoma (PTMC) is a common tumor in Hong Kong. Early immediate~     surgery has traditionally been recommended. However, given its excellent prognosis, some have~     recommended Active Surveillance (AS) as an alternative. AS involves monitoring the patients~     who have PTMC until the tumor progresses. On the other hand, a new technology of ablation has~     been developing to be an alternative treatment for thyroid nodules comparing with traditional~     surgery, named High intensity focused ultrasound (HIFU). In our previous study, HIFU is~     proved in shrinking the size of target site by 6 months gradually and effectively.~      The investigator hypothesize that HIFU is an effective treatment for PTMC. Compared to AS,~     HIFU may be a better option as it not only halts disease progression but also has a longer~     progression-free survival, longer time to tumor progression and is less likely to harbor~     active disease.~   "
18282|NCT03327623|"~     The investigators are trying to find out how common sleep apnea is in hypertrophic~     cardiomyopathy. The purpose of this study is to see if sleep apnea is common in hypertrophic~     cardiomyopathy and if its presence is associated with changes in the functioning of the body.~     The investigators want to determine if sleep apnea is associated with electrical disorders of~     the heart in patients with hypertrophic cardiomyopathy.~   "
18283|NCT03327610|"~     Ventilator hyperinflation (VHI) has been shown to be effective in improving respiratory~     mechanics, secretion removal, and gas exchange in mechanically ventilated patients; however,~     there are no recommendations on the best ventilator settings to perform the technique. Thus,~     the aim of this study was to compare six modes of VHI, concerning physiological markers of~     efficacy and safety criteria, in order to support the optimal VHI settings selection for~     mechanically ventilated patients. In a randomized, controlled and crossover study, 30~     mechanically ventilated patients underwent 6 modes of ventilator hyperinflation. The maximum~     expansion (tidal volume), expiratory flow bias criteria (inspiratory and expiratory flow~     patterns), overdistension (alveolar pressure), asynchronies and hemodynamic variables (mean~     arterial pressure and heart rate) were assessed during the interventions.~   "
18284|NCT03327597|"~     This study will assess the benefits and harms of screening for monoclonal gammopathy of~     undetermined significance (MGUS). The overall and disease-specific mortality will be compared~     between screened and not screened participants. All individuals registered as inhabitants in~     Iceland and born in 1975 or earlier have been invited to participate. The hypothesis is that~     an early detection of multiple myeloma (MM), through follow-up of MGUS, will improve overall~     survival and decrease complications associated with diagnosis and treatment of MM.~   "
18285|NCT03327584|"~     Arthrocentesis is the removal of synovial fluid for analysis of pathologic processes. Small &~     medium joint arthrocentesis will be defined as the following joints: elbow, wrist, finger,~     ankle and toe. Ultrasound (US) and landmark (LM) small & medium joint arthrocentesis are both~     performed within the clinical setting. Both techniques are considered standard of care.~     Selection of which technique to use is dependent upon the physician's preference. There is~     currently limited data comparing the two methods. The investigators hope to determine if one~     modality is more effective in terms of success rate, number of attempts, and time to complete~     the procedure.~   "
18286|NCT03327571|"~     The purpose of this study is to describe progression-free survival (PFS) in participants with~     relapsed or refractory classical Hodgkin lymphoma (RRHL), defined as the time from initiation~     of first treatment for RRHL to first documentation of relapse or disease progression, or~     death.~   "
18287|NCT03327558|"~     The objective of this study is to evaluate and compare the bioavailability of mesalamine~   "
18288|NCT03327545|"~     Myofascial pain is a clinical problem that has generated interest, debate and confusion for~     decades. According to studies anywhere between 33 and 97 % of patients with musculoskeletal~     pain visiting physicians and manual therapists are diagnosed with Myofascial Trigger Points~     (MTrPs). MTrPs are localized, hyperirritable points that are associated with palpable nodules~     in taut bands (TB) of muscle fibres. MTrPs can be classified into active and latent. Latent~     MTrPs demonstrate the same clinical characteristics as active MTrPs but they do not provoke~     spontaneous pain. The myofascial trigger points (MTrPs) are common in healthy subjects and in~     patients with musculoskeletal pain, and could produce sensitive disturbances and motor~     dysfunctions~   "
18289|NCT03327532|"~     The AHF-CORE study is a prospective, non-randomized, multicenter regional study.~      The main objective of the AHF-CORE study is to identify congestion markers (clinical,~     biological and ultrasound) at the beginning and at the end of hospitalization for acute heart~     failure that are more strongly associated with the risk of all cause death or~     rehospitalization for acute heart failure within 3 months of hospital discharge.~      Secondary objectives are:~        -  Quantify the variations in congestion markers between the beginning and end of~          hospitalization for acute heart failure.~        -  Assess the correlation between changes in congestion markers between the beginning and~          end of hospitalization.~        -  Identify the congestion markers at the beginning of hospitalization that are most~          strongly associated with residual congestion at the end of hospitalization.~        -  Identify the added value of ultrasound and biological markers of congestion in addition~          to clinical variables for the prediction of all-cause death or hospitalization for acute~          heart failure at 3 months after hospital discharge.~   "
18290|NCT03327519|"~     Insomnia is commonly reported by adults with asthma. Insomnia can worsen asthma patients'~     quality of life and increase the risk for asthma attacks.This clinical trial will compare~     sleep and asthma control in adults with asthma and insomnia who receive either an~     internet-based intervention for insomnia or an educational video about insomnia.~   "
18291|NCT03327506|"~     The aim of this study is to evaluate the efficacy of an hypnosis session, performed on the~     eve of a laparoscopic gynecological surgery, on the level of immediate preoperative anxiety~     measured by State-Trait Anxiety Index (STAI-Y) self-administered questionnaire compared to~     premedication by alprazolam®.~   "
18292|NCT03327493|"~     Refractory cardiogenic shock is characterized by a decreased in cardiac output with~     hypo-responsiveness to increasing doses of catecholamines resulting in a profound tissular~     ischemia. VAECMO, by restoring a circulatory flow, could be associated to a major reperfusion~     syndrome which may lead some patients to multiple organ failures and death. Pathophysiology~     of this syndrome includes 1/an hyper-adrenergic state secondary to the over activation of the~     sympathetic system and 2/ a major release of pro-inflammatory cytokines. As adrenoreceptors~     are also exhibited on immunes cells, the pro-inflammatory state might be enhanced by the~     over-activation of the sympathetic system.~   "
18293|NCT03327480|"~     The investigators aimed to assess the effects of two different hand orthosis on hand~     functioning, pain, disability and quality of life in patients with thumb osteoarthritis~   "
18294|NCT03327467|"~     The objective of the study is to enable access to sibling or autologous umbilical cord blood~     (UCB) infusions for children with various brain disorders.~      The use of UCB in this fashion is based on safety and efficacy data from prior and ongoing~     clinical trials at Duke University Medical Center in over 700 patients with these diagnoses~     infused with autologous or sibling UCB over the past decade.~   "
18317|NCT03327168|"~     This study investigates the significance of adenosine and A2A receptors in human brown~     adipose tissue (BAT) in vivo. Using positron emission tomography (PET), perfusion and the~     density of A2A receptors will be measured in supraclavicular BAT and other tissues in healthy~     men. The investigators hypothesize, that adenosine can activate BAT, and that adenosine A2A~     receptor density changes when BAT is activated by cold exposure.~      Understanding the mechanisms of BAT activation and the role of endocannabinoids in humans is~     important and beneficial in fighting against the epidemic of obesity and diabetes.~   "
18295|NCT03327454|"~     The main aim of this study is to ascertain general satisfaction among participants with~     rheumatic diseases with day-to-day use of the Benepali® prefilled pen by means of a~     standardised participant questionnaire. In addition, it is to be investigated whether~     differences exist in general participant satisfaction between participant groups who have~     undergone various prior treatment and/or have previous experience with application systems~     (participants new to the use of biologics, participants changing over from a prefilled~     injection or changing over from another pre-filled pen) and between participants of the~     various indication groups. Furthermore, the participants are to evaluate various aspects of~     using the Benepali® pre-filled pen based on their personal experience, such as e.g. handling,~     user-friendliness and features of the Benepali® pre-filled pen, as well as the effectiveness~     of the training on injection with the Benepali® pre-filled pen, based on participant~     satisfaction with the training received with the training pen and the evaluation of the~     training material received.~   "
18296|NCT03327441|"~     The overall goal is to assess the health benefits of almond consumption on gut microbiome~     patterns and their association with circulating disease risk biomarkers, as well as the~     processes that control those pathways. Health benefits will be assessed relative to a~     breakfast/snack bar placebo control.~   "
18297|NCT03327428|"~     Sickle cell disease is one of the most common hereditary diseases. Most severe complications~     can be avoided if the disease is detected early and treated appropriately.~      The sickle cell disease registry of the Society for Paediatric Oncology/Haematology aims at~     describing the epidemiology of sickle cell disease in German-speaking central Europe.~     Patients with sickle cell disease will be characterized clinically and genetically and~     treatment will be documented with the aim to find predictors of the course of disease.~      In addition, the registry results should provide a solid evidence base to incorporate sickle~     cell disease into routine newborn screening and to update the national guidelines for the~     management of patients suffering from sickle cell disease in Germany.~      A consortium of five university hospitals (Berlin, Frankfurt, Hamburg, Heidelberg, Ulm) has~     been mandated by the Society for Paediatric Oncology/Haematology to implement this registry.~      The number of participating centers is constantly increasing and new centers that take care~     of either pediatric or adult patients with sickle cell disease are encouraged to support the~     registry.~      For further information please refer to: http://www.sichelzellkrankheit.info/~   "
18298|NCT03327415|"~     The Nutri-Bébé 2013 survey is an observational cross-sectional study aiming to update food~     consumption, practices and nutrient intakes in children under 3 years of age in metropolitan~     France.~   "
18299|NCT03327402|"~     The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability~     of SHP465 in children aged 4 to 5 years with ADHD after multiple daily doses of 6.25~     milligram (mg) SHP465~   "
18300|NCT03327389|"~     The purpose of this study is to elucidate the effect of dexmedetomidine on renal function and~     delayed graft function after kidney transplantation~   "
18301|NCT03327376|"~     The central venous catheters (CVC) related thrombosis is an issue of importance to ICU~     clinicians.This study conducts the daily ultrasound-screening for CVC-related thrombosis~     (DUCT).Its aim is to evaluate the characteristic and regularity of the central venous~     catheters (CVC) related thrombosis in ICU patients, and optimize the screening program of~     CVC-related thrombosis.~   "
18302|NCT03327363|"~     The aims of this study is to evaluation of the clinical efficacy and stability of Information~     and Communication Technology (ICT)- based centralized monitoring system of asthma control~     monitoring in asthma patients. We planed to enroll 100 asthma patients (50 subjects using ICT~     systems, 50 controls). We will monitor the asthma control status, lung function, exacerbation~     rate and stability of ICT systems.~      This study is based upon work supported by the Ministry of Trade, Industry & Energy (MOTIE,~     Korea) under industrial Technology Innovation Program (No. 10059066, 'Establishment of ICT~     Clinical Trial System and Foundation for Industrialization').~   "
18303|NCT03327350|"~     To evaluate the effects of mechanical left atrial appendage (LAA) closure for secondary~     prevention of stroke in the patients with nonvalvular atrial fibrillation~   "
18304|NCT03327337|"~     The investigators use existing resources to carry out this new technology, in accord with the~     standard of the patients, were randomized to traditional fracture balloon tibia fixation or~     arthroscopic reduction under angioplasty, the original data and data acquisition in a certain~     period of time corresponding to the patient, through statistical and epidemiological analysis~     and comparison of the method of professional data analysis discussion and experience~     according to the analysis results, the balloon angioplasty tibial arthroscopy and traditional~     open reduction and internal fixation for the clinical differences between postoperative~     recovery of tibial plateau articular surface reduction and joint function, and feedback the~     results to guide the clinical diagnosis and treatment.~   "
18305|NCT03327324|"~     The goal of this study is to test potential functional/psychosocial benefits of improved~     sleep using a program designed to teach nursing facility staff to improve sleep promoting~     strategies and environment for nursing home residents. Sleep disturbances are quite common in~     skilled nursing facilities and affect as many as 69% of residents while staff do not fully~     understand how to improve sleep without using medications. Medications for sleep are commonly~     used as first-line therapy for older adults but this is problematic because these medications~     can lead to greater problems with thinking, more frequent falls, and even worse sleep over~     time. In addition, poor sleep can lead to depressed mood, greater trouble with thinking and~     memory, worse pain, and greater need for help with daily activities.~   "
18306|NCT03327311|"~     This is a prospective, in vivo proof-of-concept clinical study, where histopathologic~     examinations will be conducted at various timepoints following Bellafill injections.~   "
18330|NCT03326999|"~     One common anesthetic that is performed for total knee replacement surgery is spinal~     anesthesia with an adductor canal regional block, which involves injecting numbing medication~     in the thigh region for pain control after surgery. The aim of this study is to determine~     whether the addition of another regional block called obturator nerve block, which involves~     injecting numbing medication in the upper thigh region, will improve pain control after~     surgery while not sacrificing mobility after surgery.~   "
18407|NCT03325998|"~     The purpose of this study was to investigate the effects of gait training with the new~     wearable hip assist robot developed by Samsung Advance Institute of Technology (Samsung~     Electronics Co, Ltd, Korea) in elderly adults.~   "
18307|NCT03327298|"~     Background: Different methods for lumbar pedicular screw insertion have been advocated,~     however each technique has its cons and pros. Due to limited resources for O-Arm and~     navigation in our locality, the investigator was enforced to use the surgical skills to~     minimize the need for such advanced modalities.~      Aim of the study: Is to clarify the benefits of the use of free hand technique using direct~     visualization of the pedicles and disc space as the only guide for pedicular screw insertion~     using postoperative CT for evaluation of the accuracy of pedicle screw insertion.~      Patients and methods: One hundred and forty four screws were inserted in 32 patients using~     direct pedicle visualization and disc space orientation as a single intraoperative reference~     guide. The study was conducted in Zagazig University Hospitals from May, 2014 to June, 2015.~     CT was done for all patients as a direct postoperative evaluation tool.~   "
18308|NCT03327285|"~     This is a single-center, prospective clinical study evaluating safety and efficacy of~     C-CAR011 treatment in subjects with ALL after HSCT~   "
18309|NCT03327272|"~     Neural injury is a well-known complication following extreme lateral lumbar interbody fusion~     (XLIF). It has been found that up to 9.4% of patients will have either temporary or~     persistent neurologic deficit. This occurs with traversal of the psoas muscle or direct~     injury to lumbosacral plexus or sympathetic ganglion. While often temporary, it can cause hip~     flexor weakness, thigh numbness, or pain.~      Several studies have demonstrated reduced patient reported pain scores following steroid~     administration, particularly in the early postoperative period. However, few studies have~     investigated the efficacy of intraoperative local injection of corticosteroid in reducing the~     incidence and duration of postoperative pain or neurologic injury for XLIF patients.~   "
18310|NCT03327259|"~     There is literature to support both the need for and efficacy of brief interventions for~     depressive symptoms, particularly among college students.Brief behavioral activation~     interventions (BATD) have gained recognition as efficacious treatments for depression; yet a~     recent study evidenced a substantial (39%) non-response rate (Kuyken et al., 2017). In~     accordance with behavioral models of depression, the treatment involves increasing activity~     and positive experience, to break the negative reinforcement cycle maintaining depressed~     mood. Thus, strategies that may facilitate increasing activity may improve BATD outcomes. The~     objective of the current study is to examine whether briefly practicing a target activity~     during an activity planning session (modified single session of BATD) increases the~     likelihood of completing the activity during the upcoming week. We hypothesized that guided~     activity practice may improve self-efficacy within session and activity completion in the~     upcoming week. We further aim to explore whether activity completion mediates depressive~     symptom change.~   "
18311|NCT03327246|"~     The European Union's Horizon 2020 project issued a Call for Action [1] in December 2013 to~     design, develop, disseminate and evaluate new IT technologies for use in integrative~     treatment processes, with emphasis on complex adult patient. Assuta Hospital submitted a~     proposal for this call, as part of a broad consortium of 10 participants from various~     European countries.~      The CONNECARE consortium has formulated a general model for integrative treatment, and is~     currently in the technological development stages, to create a smart (supportive decision)~     and adaptive system that supports integrative treatment processes both in the hospital and in~     the community for personalized treatment in complex chronic patients. The development~     includes a significant integrative component of self-care management by the patient and / or~     the primary caregiver.~      Following the completion of the technological development, clinical trials will be held in~     four organizations throughout Europe - Assuta Hospital in Ashdod in cooperation with the~     Maccabi community in Ashdod, two centers in Catalonia and the Groningen region in the~     Netherlands. The purpose of the studies is to assess the impact of the implementation of the~     model, processes and digital tools that will be built during the project.~   "
18312|NCT03327233|"~     The European Union's Horizon 2020 project issued a Call for Action [1] in December 2013 to~     design, develop, disseminate and evaluate new IT technologies for use in integrative~     treatment processes, with emphasis on complex adult patient. Assuta Hospital submitted a~     proposal for this call, as part of a broad consortium of 10 participants from various~     European countries.~      The CONNECARE consortium has formulated a general model for integrative treatment, and is~     currently in the technological development stages, to create a smart (supportive decision)~     and adaptive system that supports integrative treatment processes both in the hospital and in~     the community for personalized treatment in complex chronic patients. The development~     includes a significant integrative component of self-care management by the patient and / or~     the primary caregiver.~      Following the completion of the technological development, clinical trials will be held in~     four organizations throughout Europe - Assuta Hospital in Ashdod in cooperation with the~     Maccabi community in Ashdod, two centers in Catalonia and the Groningen region in the~     Netherlands. The purpose of the studies is to assess the impact of the implementation of the~     model, processes and digital tools that will be built during the project.~   "
18313|NCT03327220|"~     This study is designed to investigate whether iovera° treatment prior to Total Knee~     Arthroplasty (TKA) decreases cumulative patient opioid use over the course of 6 weeks~     following TKA while maintaining similar levels of pain relief. The study will also~     investigate whether there is a relationship between patients treated with iovera° and patient~     reported pain and function as measured by KOOS JR., NRS for Pain; use of hospital services~     post-TKA and improved physical rehabilitation as measured by range of motion.~   "
18314|NCT03327207|"~     The goal of this study is to characterize the microbiome of children with Growth Hormone (GH)~     deficiency, following GH treatment initiation and compare it to healthy children and develop~     a model for predicting growth response to GH treatment based on clinical and laboratory~     parameters.~   "
18315|NCT03327194|"~     A hearing loss affects the quality of life and the natural development of children.~      The new generation of hearing devices provides a huge number of options to them. These new~     hearing aids are often aesthetically acceptable, less invasive and user-friendly.~      The ADHEAR Non-Implantable Bone Conduction Hearing System is connected directly to the skin~     with a special adhesive adapter. The device transmits the sound to the mastoid by vibrating~     on the skull and stimulates the inner ear without any previous surgery.~      The objective of this study is to evaluate of the audiological benefit and subjective~     satisfaction of ADHEAR Audio Processor with Adhesive attachment in a group of children~     suffering from conductive hearing loss and/or single sided deafness.~   "
18318|NCT03327155|"~     Despite all prevention efforts, many people in Australia continue to be infected with HIV.~     The Seventh National HIV Strategy 2014-2017 in Australia aims to work towards the elimination~     of HIV transmission by the year 2020. This project will evaluate a new additional way to~     lower people's chances of getting HIV. It will provide pre-exposure prophylaxis (PrEP) to~     people who are at high risk for HIV and evaluate what impact this new prevention approach~     will have on HIV in WA at the community level.~      The drug used in PREPIT-WA is called generic TDF/FTC (made by Mylan Laboratories Ltd.). The~     generic TDF/FTC is a single tablet made up of two HIV medications: tenofovir disoproxil~     fumarate and emtricitabine (a combination known as TDF/FTC). TDF and FTC have been widely~     used for many years to treat HIV. When used with other medicines in people who already have~     HIV, TDF/FTC reduces the amount of HIV virus in the blood. TDF/FTC does not cure HIV or AIDS,~     and it is not an HIV vaccine.~      As a treatment for people who already have HIV, TDF/FTC is approved for use in most of the~     world, including Australia. As a medicine for PrEP, to lower chances of HIV in those who are~     not infected, TDF/FTC has been approved in the US, and Truvada® (which contains TDF/FTC made~     by Gilead Sciences Inc.) was approved for PrEP in Australia in May 2016. At the start of the~     project, the generic TDF/FTC is not approved in Australia for the use as PrEP but it may~     become registered for use and more freely available in Australia in the future.~   "
18319|NCT03327142|"~     To analyze the diagnostic performance, safety, impact on clinical management, predictors of~     malignancy and cyto-pathological correlation of the EUS-FNA with AG. National multicenter~     retrospective study. Mailing-SEED partners. Participation: 17 Spanish centers. Inclusion~     period: April / 2003 to April / 2016 Inclusion criteria: All AG (Left / Right) punctured by~     EUS.~      A review of 205 EUS-FNA of AG in 200 patients is included.~   "
18320|NCT03327129|"~     Since capability for suicide involves overriding potential pain, and the opioid system plays~     a strong role in controlling pain perception, it follows that capability for suicide may be~     impacted by the opioid system. The goal of the proposed research is to identify the neural~     network underlying capability for suicide in order to determine if it can be a target for~     identifying high-risk individuals and for intervention.~   "
18321|NCT03327116|"~     Atopic dermatitis (AD) is a chronic inflammatory skin disease associated with pruritus.~     Methotrexate can be used to treat refractory disease to conventional therapy.~      It will be conducted a single arm trial with twelve adult patients with moderate to severe AD~     on methotrexate for 24 weeks.~      Investigators intend to evaluate the effect methotrexate on cytokines and chemokines involved~     in the inflammatory response, on IgE levels, on pruritus, and on EASI and SCORAD severity~     scores.~   "
18322|NCT03327103|"~     Prostate cancer is a commonly diagnosed cancer, and is the second leading cause of cancer~     deaths among men in the U.S. The subgroup of men with advanced prostate cancer is~     particularly vulnerable to difficult choices for treatment because of the nature of their~     disease and having limited options. This study will test the use of an innovative Registered~     Nurse-Community Patient Navigator team delivered interactive mHealth decision aid for~     patients with advanced prostate cancer to help facilitate informed shared decisions about~     anti-cancer treatment that affects their quality of life.~   "
18323|NCT03327090|"~     This study is aimed to investigate the effect of the Kinesio Tape facilitation technique on~     the muscle power performance of elite weightlifters.~   "
18324|NCT03327077|"~     The purpose of this study is to study the impact of Live Preferential Music on the patient~     perception of pain and management of pain syndromes in the ED.~   "
18325|NCT03327064|"~     This is a randomized, double-blind, placebo-controlled biomarker study in renal transplant~     recipients with actinic damage and a history of basal cell carcinomas and/or cutaneous~     squamous cell carcinomas. There will be two arms to the study: 1) daily oral UAB30 for 28~     days; and 2) daily oral placebo for 28 days. The total duration of the study is anticipated~     to be 5 years. The hypothesis being tested is that a significantly greater percentage of~     subjects randomized to oral UAB30 over a period of 28 days will achieve ≥30% reduction in~     biomarkers of proliferation and ≥30% increase in apoptosis biomarkers than those who receive~     placebo. Cyclin D1 will serve as the primary biomarker.~      This investigation will determine whether subjects randomized to UAB30 have an increase in~     all trans-retinoic acid responsive genes in the skin compared to those receiving placebo.~     This will include an examination of target effects of UAB30 by evaluating its effects in vivo~     in humans on the DNA damage response and Src signaling pathways.~   "
18326|NCT03327051|"~     Probiotics are over-the-counter dietary products with microorganisms that are generally~     consumed for health benefit. However, the durability of these microorganisms is unclear,~     particularly when it passes through the highly acidic environment of the stomach. We will~     test the colonization of these microorganisms among individuals who consume probiotics with~     and without acid suppression therapy.~   "
18327|NCT03327038|"~     Inflammatory Bowel Diseases (IBD) are chronic debilitating disorders of the gastrointestinal~     tract that comprise two subtypes; Crohn's Disease (CD) and Ulcerative Colitis (UC). Canada~     has among the highest incidence rates of CD and UC in the world, as high as 20.2 and 19.5 per~     100,000 respectively. Although, IBD can occur at any age, it is frequently diagnosed in the~     second and third decades of life, at a time when vulnerable individuals are entering the~     prime years of their lives. This age of onset, coupled with the recurrent and frequently~     relapsing nature of these disorders, can significantly impair the psychological well-being of~     patients. Therefore, it's not surprising that patients with IBD report a higher burden of~     depression and anxiety in comparison to the general population. The prevalence of depression~     and anxiety in patients with IBD have previously been linked to the following: (1) Increased~     risk of surgery; (2) Increased number of relapses; (3) Clinical recurrence; (4) Treatment~     failure and earlier retreatment; (5) Lower self-reported quality of life, satisfaction, and~     medication adherence; (6) and Increased health care utilization. Although, depression and~     anxiety are highly treatable conditions, they are often under-recognized and under- treated~     in patients with IBD. The most common treatments for these disorders are pharmacological~     agents and psychological treatments. Psychological treatments like Cognitive Behavioral~     Therapy (CBT) have extensive support for treatment of depression and anxiety. The major~     advantage of psychological treatments over pharmacological agents is their ability to sustain~     improved depression and anxiety symptoms in patients post-treatment. As part of this study,~     we aim to evaluate the following:~      Specific Aim #1: Determine whether a psychological intervention, involving web-based CBT, is~     effective in ameliorating depression and anxiety symptoms in a cohort of adult IBD patients.~      Specific Aim #2: Determine the durability effect of the intervention on sustaining improved~     psychiatric symptoms.~      Specific Aim #3: Determine the impact of a psychological on IBD-specific and~     psychiatric-specific health care utilization.~   "
18328|NCT03327025|"~     An intervention to assist pediatric cancer survivors to behaviorally manage late effects.~   "
18329|NCT03327012|"~     This study evaluates the efficacy and safety of Panlongqi tablet compared with placebo in the~     treatment of knee osteoarthritis in adults.Half of participants will receive Panlongqi tablet~     in combination,while the other half will receive a Placebo.~   "
18333|NCT03326960|"~     The investigators will perform clinical studies to test the hypothesis that participants who~     have total hip/knee replacement under propofol anesthesia will have less POCD/POD as compared~     to participants who have the surgery under sevoflurane anesthesia, and POCD/POD is associated~     with retinal nerve fiber layer (RNFL) thickness, as well as Serum level of vitamin B12, folic~     acid, homocysteine and human myeloid differentiation protein-2 (MD-2s). The investigators~     plan to perform the studies in 200 participants in Shanghai 10th People's Hospital.~   "
18334|NCT03326947|"~     To investigate the predictive value of stathmin expression as a predictive biomarker in OSCC~     patients, who treated with TPF (docetaxel, cisplatin and 5-fluorouracil ) induction~     chemotherapy followed by radical surgery and radiotherapy/chemoradiotherapy.~   "
18335|NCT03326934|"~     The purpose is to conduct a randomized, single-masked crossover study to determine if acute~     consumption of a commercially available, highly palatable dark chocolate bar can improve~     visual performance. Vision testing will include multiple measures of contrast and color~     perception, reaction time, effects of distraction on visual performance during simulated~     hands-free phone calls, simulated marksmanship, as well as multiple, objective~     electro-diagnostic tests including standard and color visual-evoked potentials and various~     types of electro-retinograms to assess visual pathway function.~   "
18336|NCT03326921|"~     This phase I trial studies the side effects and best dose of CD4+ and CD8+ HA-1 T cell~     receptor (TCR) T cells in treating patients with acute leukemia that has come back or does~     not respond to treatment following donor stem cell transplant. T cell receptor is a special~     protein on T cells that helps them recognize proteins on other cells including leukemia. HA-1~     is a protein that is present on the surface of some peoples' blood cells, including leukemia.~     HA-1 T cell immunotherapy enables genes to be added to the donor cells to make them recognize~     HA-1 markers on leukemia cells.~   "
18337|NCT03326908|"~     Improvement of retinal medical imaging opens new perspectives for exploring the retinal~     structures. Optical coherence spectral domain (SD-OCT), which has been widely used in the~     last ten years, is certainly the most advanced device. In the analysis of patients without~     retinal disease using SD-OCT, granulations in the interdigitation area were observed. These~     granulations have never been described with this device. They could correspond either to the~     degradation products of the external segments of the photoreceptors or to melanosomes. A~     descriptive study of these granulations at different examination times and in different~     lighting situations would allow us to obtain essential information for a better understanding~     of this area. Based on the results, larger studies could explore this area more finely in~     retinal pathologies involving dysfunctions of photoreceptors or of the pigmentary epithelium.~   "
18338|NCT03326895|"~     This prospective clinical study will compare a powered circular stapler to commercial~     mechanical staplers for performance issues in patients scheduled to undergo colectomy with~     left-sided colon anastomosis.~   "
18339|NCT03326882|"~     The main objective of this study was to evaluate the intubation time of Glidescope compared~     with Macintoch laryngoscope in pediatric patients, ease of intubation, and cardiovascular~     changes during intubation.~   "
18340|NCT03326869|"~     The objective of this study is to evaluate the Raindrop® Near Vision Inlay for the~     improvement of near vision in presbyopes implanted in corneal pockets with a delayed or a~     non-delayed approach.~   "
18341|NCT03326856|"~     This study tests an investigational drug formulation called ET-01, botulinum toxin, Type A,~     topical, in lateral canthal lines (LCL).~   "
18342|NCT03326843|"~     Phase 3b open-label, multicenter study to evaluate the safety and efficacy of avatrombopag in~     subjects with thrombocytopenia scheduled for operations to critical sites or operations with~     a high risk of bleeding.~   "
18343|NCT03326830|"~     The purpose of the present project is to compare High-Flow Nasal Oxygen therapy with Standard~     Oxygen therapy, initiated in the prehospital setting in patients with acute hypoxemia~     respiratory failure, in terms of oxygenation at arrival to the hospital and need of~     mechanical ventilation during the subsequent 28 days~   "
18344|NCT03326817|"~     The study is to investigate the effect of a soft robotic glove approach providing continuous~     passive motion of fingers (flexion and extension) on degenerative arthritis patients. The~     approach may help reduce pain, maintain mobility and flexibility and to improve hand~     function.~   "
18345|NCT03326804|"~     This is a prospective, non-randomized, consecutive series, multicentre, observational study~     to evaluate the clinical outcome of ceramic-on- ceramic hip resurfacing arthroplasty using~     the ceramic, non-porous, non-cemented H1 Hip Resurfacing Arthroplasty. It includes a safety~     study followed by an efficacy study. Patients will be followed up for 10-years~     postoperatively.~      The primary aim is to confirm the safety of the H1 hip resurfacing prosthesis by~     demonstrating non-inferiority of the H1 device in terms of survivorship.~      The secondary is to evaluate superiority of the ceramic-on-ceramic H1 hip resurfacing~     prosthesis compared to Metal-on-Metal (MoM) hip resurfacing in terms of absence of metal ion~     release.The primary end point is revision for any reason.~   "
18346|NCT03326791|"~     The ASAC trial is a Scandinavian, multi-center, double-blinded, randomized,~     placebo-controlled study to determine whether adjuvant treatment with low-dose~     acetylsalicylic acid (ASA) can improve disease free survival in patients treated with~     resection for colorectal cancer liver metastases (CRCLM).~      Several studies have shown beneficial effect of ASA on primary prevention of CRC and the~     investigators group and others have shown a potential association of ASA also taken after the~     diagnosis on CRC survival in registry-based studies (secondary prevention). Up to 800~     patients operated for CRCLM will be randomized to Arm#1 ASA 160 mg once daily or Arm#2~     Placebo for a period of 3 years or till disease recurrence. The patients will be treated and~     followed up according to standard of care and the National Guidelines.~      The ASAC trial will be the first clinical interventional trial to assess the beneficial role~     of ASA in recurrence of CRC liver metastases and survival. ASA is an inexpensive, well~     tolerated, and easily accessible drug that will be highly potential as adjuvant drug in~     secondary prevention of CRC liver metastases if the study shows a beneficial effect. This~     trial will also investigate the effect of ASA as adjuvant treatment on Health-related Quality~     of Life and the cost-effectiveness.~   "
24317|NCT03248687|"~     The investigators will be enrolling children with distal radius buckle fractures, treating~     them with a removable splint and randomizing them to follow up as needed vs required follow~     up with a primary care physician 1-2 weeks after the ED visit.~   "
18348|NCT03326765|"~     The proposed research project is aimed at further characterization of sleep problems and~     evaluation of their impact in children and adults with TSC, excluding epilepsy as~     contributing factor. Questionnaire-based studies have shown that sleep problems occur in up~     to half of the children and a third of adults with tuberous sclerosis complex (TSC). However,~     there is only limited information on the nature of sleep problems and their impact on~     patients with TSC and their families.~   "
18349|NCT03326752|"~     This open-label, multicenter, dose-escalation and expansion trial is designed to evaluate the~     safety and preliminary efficacy of inhaled DV281 in combination with an approved anti-PD-1~     inhibitor for the treatment of NSCLC and to select a recommended phase 2 dose (RP2D).~   "
18350|NCT03326739|"~     Critically ill patients in the emergency department commonly require arterial line placement~     for continuous direct blood pressure monitoring, frequent arterial blood gas sampling, and~     frequent blood sampling. Trans-radial catheterization has been shown to reduce access site~     complications and increase patient comfort compared to trans-femoral access. Radial artery~     access on the first attempt is optimal; attempts at reentry delay care and increase the risk~     of vascular spasm, hematoma, infection, neurovascular injury, and pain. The traditional pulse~     palpation method of radial artery cannulation can be challenging, especially in patients with~     weak pulses (i.e. morbidly obese or hypotensive individuals).~      A review of literature suggests that ultrasound guided trans-radial catheterization compared~     to standard pulse palpation reduces access time and increases rate of first-entry success~     when performed by physicians trained in ultrasound. Thus, complications ascribed to reentry~     are prevented and timely care is provided.~      To the investigator's knowledge, only one other prospective study has been conducted to~     assess the utility of ultrasound guided radial artery cannulation in the emergency~     department. Due to the paucity of literature to support the use of ultrasound guided~     trans-radial catheterization in critically ill patients, the study will aim to provide~     further data on the topic. Both techniques are considered standard of care.~   "
18351|NCT03326726|"~     Medline 2% CHG cloth (Active) - A single cloth from the pack was used per treatment area. The~     investigational test article was applied topically by vigorously scrubbing the skin in a back~     and forth motion for three minutes (and halfway through the 3-minute application time, the~     cloth was turned over) over the treatment area (7 x 10 of the subject's back), and the skin~     was allowed to air dry.~   "
18352|NCT03326713|"~     GRACE is a randomized 3-arm trial to determine the comparative effectiveness of two remote~     cancer communication interventions: 1) a targeted generic print (TP), or 2) a tailored~     telephone-based counseling and navigation intervention (TCN).~   "
18353|NCT03326700|"~     In the literature, there are several studies that compare Laparoscopic totally~     extraperitoneal hernia repair (TEP) with Lichtenstein hernia (LH) repair. There are no~     studies that compare sexual functions on men's health and quality of life. Our aim was to~     study the sexual functions of men, who underwent TEP or LH repair according to Health Survey~     Scoring Demonstration (SF36) and The International Index of Erectile Function (IIEF).~   "
18354|NCT03326687|"~     Many individuals have difficulty with word retrieval, also called anomia, following~     cerebrovascular accident (CVA). These difficulties impede effective communication in everyday~     conversations and can negatively impact the resumption of pre-injury activities. Even after~     rehabilitation specifically targeting these areas, many individuals report persistent~     difficulties with anomia. Additionally, most individuals report that these difficulties~     worsen when distracted, fatigued, or when attempting to divide attention between tasks. Given~     that everyday activities frequently require efficient communication when attention is divided~     (e.g., walking and talking), it is important to investigate viable interventions to improve~     these skills.~      Recovery from CVA and resumption of pre-injury activities is best supported by rehabilitation~     interventions that are functional and directly related to the tasks individuals aim to~     resume. For example, a therapy task requiring an individual to generate a grocery list and~     then go to a grocery store to acquire the items on the list has a greater impact on recovery~     for the underlying language and cognitive skills than a series of generic language and~     cognition tasks completed in a therapy room. In addition to this, interventions that~     incorporate dual-task practices tend to have better outcomes than more traditional~     single-task practices.~      The aim of this study is to compare the effectiveness of pairing word retrieval tasks with~     physical endurance tasks versus presenting them in isolation. Additionally, this study will~     investigate whether improvements in word retrieval and physical endurance generalize to the~     functional, everyday task of holding a conversation while walking. The researchers~     hypothesize that participants will perform better on word retrieval tasks after participating~     in dual language and physical tasks than after participating in language tasks presented in~     isolation.~   "
18355|NCT03326674|"~     The primary objective is to compare the efficacy of tesetaxel plus a reduced dose of~     capecitabine versus the approved dose of capecitabine alone in patients with HER2 negative,~     HR positive MBC previously treated with a taxane in the neoadjuvant or adjuvant setting.~      Approximately 600 eligible patients will be randomly assigned in a 1:1 ratio to either Arm A~     (tesetaxel plus a reduced dose of capecitabine) or Arm B (approved dose of capecitabine~     alone).~   "
18356|NCT03326661|"~     Peritonsillar abscess (PTA) has a relatively high incidence of 41 per 100,000/year in~     Denmark. In spite of that, there is no regional or national consensus on treatment of PTA.~     Abscess drainage can be done by aspiration, incision or acute tonsillectomy. Several studies~     show that incision and aspiration are equally successful. The aim for this study is to~     compare aspiration to acute tonsillectomy (tonsillectomy a chaud) in a RCT study regarding~     sick-leave days, days of admission, pain, consumption of antibiotics, consumption of~     painkillers and patients´ self-assessed quality of life.~   "
18357|NCT03326648|"~     The purpose of this study is to investigate mechanisms underlying the reduction in muscle~     quality (the ratio between muscle strength and muscle size) with aging, and to investigate~     how these factors are affected by strength training and protein supplementation. It is~     already established that muscle quality defined as the ratio between the strength and the~     size of a muscle is improved with strength training, even in frail elderly individuals.~     However, the relative contribution of factors such as activation level, fat infiltration,~     muscle architecture and single fiber function is unknown. The main focus of this study is to~     investigate the relationship between muscle quality and muscle protein breakdown, as~     insufficient degradation of proteins is hypothesized to negatively affect muscle quality.~   "
18358|NCT03326635|"~     Study design. The study FRAGIREA is a multicentric prevalence study on the frequency of~     frailty among elderly patients and the quality of management. The voluntary ICUs will have to~     include all patients ≥ 70 years on a limited period (1 month) or until the number of 15~     inclusions is reached. The frailty is going to be evaluated by a frailty score adapted to the~     ICU, based on informations given by the patient's family.~      It is a descriptive non-interventional study, aiming at the description of frequency of~     frailty and management of the patient in order to set-up a prospective future study on the~     potential role of early rehabilitation of ageing patients in ICUs.~   "
18360|NCT03326609|"~     Background: Local anesthetic (LA) concentration and nerve block duration is sparsely~     described in a heterogenic study mass.~      Aim: To investigate the effect of LA concentration on peripheral nerve block duration in~     healthy volunteers.~      Methods: Randomization of 60 healthy volunteers who will receive 1 of 5 different volumes of~     LA (ropivacaine) using a constant dose.~      Primary endpoint: Sensory nerve block defined by insensitivity towards cold.~   "
18361|NCT03326596|"~     Hemorrhage remains the leading cause of maternal death worldwide. Tranexamic acid has been~     shown to reduce rates of hemorrhage when given prophylactically prior to cesarean delivery.~     It has also been shown to be an effective treatment in response to hemorrhage after a vaginal~     delivery. The aim of this study is to assess the impact of TXA on hemorrhage rates when given~     prophylactically prior to all deliveries.~   "
18362|NCT03326583|"~     The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of ESRD Patients With~     Hyperkalemia (potassium greater than 5 milliequivalents per liter) is a non-randomized,~     crossover study. This is an open-label, pilot clinical trial with 3 sequential phases of (a)~     2 weeks of no intervention, (b) 12 weeks of Patiromer treatment, and (c) 6 weeks of no~     intervention. Treatment with Patiromer will be initiated at a dose of 8.4 grams, once daily~     and observed for a week, then uptitrated to 16.8 grams once daily. Eligible study subjects~     will collect stool samples and provide blood and urine samples.~   "
18363|NCT03326570|"~     The goal of this clinical research study is learn about side effects and the success of~     bronchoscopies when performed in cancer patients with and without symptoms.~      This is an investigational study.~      Up to 110 patients will take part in this study. All will be enrolled at MD Anderson.~   "
18364|NCT03326557|"~     Nowadays, more and more women embark on pregnancy with previous Caesarean scar. One in five~     pregnancies requires induction of labour. The use of non-pharmacological methods (methods~     without using medication) has been gaining popularity for women who are not good candidates,~     such as women with previous Caesarean scar, for an induction with medications such as~     prostaglandin. Labour induction with prostaglandin carries higher risk of uterine rupture and~     thus it is not routinely offered to women with previous Caesarean delivery in Sibu Hospital.~     Non-pharmacological methods of induction of labour appear to be safe in women with previous~     Caesarean delivery. However, various methods are available and the efficacy among them remain~     in doubt.~      In Sibu Hospital, membrane sweeping, which is a type of non-pharmacological method, is~     routinely offered to women with previous Caesarean delivery who require induction of labour.~     However, membrane sweeping may not exert its labour induction effect immediately and the~     delivery may be delayed by up to 8 days. This may render a proportion of women to resort to~     repeated Caesarean section for failed induction.~      Transcervical Foley catheter insertion is another non-pharmacological methods for labour~     induction. Foley catheter, which is made from latex rubber, is inserted into the womb. The~     balloon will be inflated and this put pressure on the cervix and encourages dilatation. This~     method may successfully stimulates labour and the catheter falls out once the cervix dilates~     to 3 centimeters.~      The benefits of the Foley catheter:~        -  A favourable and safe option for mothers who are hoping for a vaginal birth after~          Caesarean. It is estimated that 4-7 in 10 women with previous Caesarean undergoing~          labour induction with Foley catheter will have successful vaginal births.~        -  Cause the cervix to mechanically open without involving medication.~        -  Reduced risk of uterine rupture compared to induction with prostaglandin.~        -  Less risk of fetal distress compared to induction with prostaglandin.~      The risks of Foley catheter:~        -  Vaginal bleeding (1.8%)~        -  Pain requiring removal of catheter (1.7%)~        -  Baby moving from head down to breech (1.3%)~        -  Fever (1%) which is lower than induction with prostaglandin.~        -  The risk of uterine rupture is similar to women undergoing spontaneous vaginal birth~          after Caesarean.~      The aim of this study is to compare the effectiveness of two types of non-pharmacological~     methods, ie. membrane sweeping and transcervical Foley catheter for induction of labour in~     women with previous Caesarean delivery.~   "
18365|NCT03326544|"~     Knee osteoarthritis, as a progressive disease is one of the most common causes of pain, motor~     disorder and disability in the elderly. By increasing age, the cartilage is eroded and~     endures degenerative changes due to physiological and biomechanical changes as well as~     metabolic effects and trauma . Non-surgical interventions for pain control of knee~     osteoarthritis include weight loss, exercise, changes in daily activities, physiotherapy,~     nonsteroidal anti-inflammatory drugs (NSAIDs) and analgesics .However ,the intra-articular~     injection is recently recommended by many studies such as corticosteroids, hyaluronic acid,~     Growth hormone, dextrose ,and platelet rich plasma.~      Intra-articular injection of platelets are activated and undergo degranulation, releasing a~     range of growth factors, including transforming growth factor beta (TGF-β), platelet-derived~     growth factor (PDGF), insulin-like growth factor, vascular endothelial growth factors,~     epidermal growth factors and basic fibroblast growth factor 2. These growth factors are~     thought to activate a variety of signaling pathways, which promote healing of bone and soft~     tissue.Also,some minimally invasive therapeutic options have been effective in pain relieve~     in KA, such as ultrasound-guided saphenous nerve block .~   "
18366|NCT03326531|"~     Slipped Capital Femoral Epiphysis (SCFE) treated with one screw in situ fixation results in~     an altered gait. It is thought that the protraction of the pelvis at the affected side, seen~     in patients with unilateral stable SCFE, is a compensatory mechanism to reduce out-toeing and~     thereby improve foot positioning during gait. This study will evaluate this hypothesis since~     only a few studies are conducted evaluating gait in treated SCFE. It is also thought that~     this pathology results in an impaired balance. Computer Assisted Rehabilitation Environment~     (CAREN) will be used to investigate these two questions.~   "
18367|NCT03326518|"~     Subjects referred for abdominal or thoracoabdominal CT-examination will be randomised to~     either the three contrast agents Lumentin® 44, Omnipaque® or Movprep. The difference in~     contrast density, as observed in the CT-examination, between lumen and wall (mucosal lining)~     will be compared by the three contrast agents.~   "
18368|NCT03326505|"~     This study aims at expanding Umbilical Cord derived Mesenchymal Stem Cells (MSCs) to a~     clinical scale according to Good Laboratory Practice and study its efficacy when compared to~     a Supervised Physical Therapy Program alone.~   "
18369|NCT03326492|"~     There is little or no assessment under real-use conditions of the efficacy and the tolerance~     in the short, medium and long term of the antivenoms currently on the market and used in the~     treatment of snake bites.~      The main objective is to assess the short term tolerance (< 2 hours post-injection) of the~     antivenom Inoserp Pan-Africa® (temporary market authorization) from Inosan laboratory~     currently available in Cameroon.~   "
18370|NCT03326479|"~     This repository is a multi-center, outcomes study designed to retrospectively collect data on~     the demographics, presentation, diagnosis, treatment, cost of associated care, quality of~     life, and outcomes of subjects utilizing Caris Molecular Intelligence® (CMI) Services for the~     treatment of cancer. Prior to enrolling a subject, the subject's physician will have made the~     independent decision whether or not to utilize the drug associations provided by CMI and made~     clinical treatment choices as appropriate. Thus, data captured and reported provides a real~     world perspective on diagnosis, treatment, cost, and outcomes.~   "
18428|NCT03325725|"~     This study evaluates the medical device Newbreez LD is designed to protect the lower airways~     from saliva, liquids and food aspirations in tracheotomized patients suffering from chronic~     aspirations that require specific care and may lead to complications, including inhalation~     pneumonia.~   "
18372|NCT03326453|"~     The better form of ridge will provide using wider implants that can have better abilities to~     with stand forces and to prevent alveolar bone loss as much as possible. Ridge expansion~     gained some popularity due to easiness compared to any other procedure that can gain bone.~     However, this treatment modality needs to be evaluated as compared to Mini Dental Implants~     (MDIs) over denture in thin mandibular ridge.~      In mandibular edentulous patients having thin ridge, does the mini implant supported over~     denture, compared to the conventional implant supported over denture after bone expansion~     affect bone height around implants?~   "
18373|NCT03326440|"~     Purpose of the study~        1. To assess whether offering visual information to patients with prostate cancer prior to~          receiving RT increases the participant's compliance.~        2. To assess whether increased compliance translates into reduced side effects from RT~          (assessed with a quality of life questionnaire).~      Type of study. This is a randomised control trial which will include 170 patients with the~     histological diagnosis of prostate cancer in the study arm and 170 patients with the~     histological diagnosis of prostate cancer in the control/standard arm.~   "
18374|NCT03326427|"~     Attention-Deficit/Hyperactive Disorder (ADHD) in adults is associated with global impairments~     and deficits in quality of life. The ADHD functional impairments during adulthood usually~     persist even after adequate medication treatment. The Skill Training Group of the Dialectical~     Behavioral Therapy (DBT) is one of the group therapies that had been adapted for the specific~     treatment of ADHD patients. Our primary aim is to explore the feasibility of the approach in~     different culture and to evaluate the efficacy of the Skill Training Group as an add-on~     treatment for adults using ADHD medication. This is a Randomized Clinical Trial comparing the~     Skill Training Group added to stimulants to treatment as usual. 52 adults previously~     diagnosed with ADHD and treated with stimulants in our ADHD outpatient program will be~     enrolled. Only patients with residual symptoms will be included (ADHD-Self Report Scale -~     ASRS ≥ 20). The intervention comprises the standard 12 sessions therapy program. The groups~     will have between 8 and 12 patients each, and will be conducted by a trained DBT therapist~     with supervision from a senior DBT therapist. The primary outcome will be the ASRS scores.~     Secondary outcomes include scores in ADHD Quality of Life, Beck's Depression Inventory,~     Beck's Anxiety Inventory, and performance in a neuropsychological test (difference between~     pre and post-intervention) (Stop Signal Task). Adherence to the protocol will also be~     checked. The recruitment was initially scheduled for beginning in November.~   "
18375|NCT03326414|"~     Mechanical ventilation is indispensable for most of surgical interventions but can induce~     lung injury even in pulmonary healthy patients. This can lead to postoperative pulmonary~     complications. These adverse effects could be prevented by a better monitoring of~     intraoperative lung function. Electrical impedance tomography is able to visualize aeration~     within the lung in real time.~      The planned study investigates the influence of different levels of positive endexspiratory~     pressure and different tidal volumes on the aeration.~   "
18376|NCT03326401|"~     Including eye health, nutrition plays a vital role for the sustainability of individuals~     health life. There is an increasing global concern about the issues related with eye health.~     In 2010, in order to take attention to these issues, World Health Organization (WHO) defined~     the main reasons of vision disorders as refraction defects of eye diseases (43 %), cataract~     (33 %), glaucoma (2 %), age-related macular degeneration (AMD) (1 %), diabetic retinopathy (1~     %) and undetermined natural reasons (18 %). This report also stated the three biggest reasons~     of blindness as cataract (51 %), glaucoma (8 %) and AMD (5 %).~      AMD is a multi-factorial disease in which the genetic predisposition plays important role~     with environmental factors and metabolic conditions, except for age. Especially cigarette is~     the secondary important risk factor for dry-type AMD. In the Age Related Eye Disease Study~     (AREDS), it was stated that AMD prevalence is higher in white races, compared with races~     which are not white. At the same time, AREDS searched the effect of diet supplements on the~     progression of AMD disease. In terms of the patients followed for six years, it was reported~     that the formulation C and E vitamins, beta carotene and zinc decreased the progression risk~     of AMD from middle levels to advanced levels by 34 %. In AREDS-2 study completed in 2012, it~     was shown that the extraction of beta carotene from the formulation and the decrease of zinc~     did not affect the progression rate of the disease. In the group using beta carotene,~     including persons who were used to smoke but gave up at least one year ago, the rate of~     becoming lung cancer was observed as substantially high. Moreover, the use of lutein and~     zeaxanthin instead of beta carotene in the formula did not increase the risk of lung cancer.~     In addition, it was shown that omega-3 fatty acids did not decrease risk progression.~      In current data, the effect of the intake of carotenoid and antioxidant increased with diet~     on AMD is not coherent. Likewise, the epidemiological evidences about the relation between~     diet fat intake and AMD are contradictory. The consumption of fatty fish is related with~     increased poly-unsaturated fatty acid intake and decreases the risk of AMD. However, it was~     reported the high rate of total fat intake in other studies as risk factor for AMD. In~     another study, there was not any important relation found between diet fat intake and AMD~     occurrence after the correction of other variables. In the interventional AREDS-2 study, it~     was reported that the additional intake of long-chain omega-3 poly-unsaturated fatty acids~     did not have any beneficial effect.~      The pathophysiological mechanism responsible from the possible relation between obesity and~     AMD is not clearly known. There are various hypotheses about how obesity causes AMD. In the~     first hypothesis, obesity can cause AMD after obesity increases systematic oxidative stress.~     In the second hypothesis, obesity can play a role in AMD pathophysiology as the cause of~     hyperleptinemia. The studies also prescribed that inflammation could play a role in the~     progression of AMD and also showed that plasma fibrinogen and other inflammation indicators~     could be related with late AMD. In Pathologies Oculaires Liées à l'Age (POLA) study made with~     the participation of many Europeans, it was observed that the progression of late AMD~     increased by two times in obese individuals and in early AMD, obesity did not affect the~     progression of disease. In the treatment of this disease which have age-related progression,~     proper nutrition, vitamin/mineral/supplement usage and the development of precautionary~     strategies play an important role.~      When compared with Body Mass Index (BMI), it was found that the measure of abdominal obesity~     (waist/hip rate and waist circumference) was the better determinant of chronic diseases such~     as diabetics and cardiovascular disease. Some evidences in the United States of America~     indicated that the relation between waist/hip rate and AMD gave stronger results when~     compared with the relation between BMI and AMD. For middle age cohort, after six years of~     follow-up, a group of researchers reported that the decrease of waist/hip rate also decreased~     the risk of AMD and the results were the same for waist circumference, even if the evidences~     were weak. In another study, it was reported that the increase of waist/hip rate or waist~     circumference also increased the progression of AMD.~      This study was planned with the aim of determining the occurrence of AMD by evaluating~     dietary total antioxidant capacity, diet components and some anthropometric measures of~     individuals having age related macular degeneration (AMD). In the study, the possible effect~     of nutrition on the occurrence of disease was evaluated by comparing healthy individuals with~     dietary total antioxidant capacity and some anthropometric measures of individuals with AMD.~   "
18377|NCT03326388|"~     Phase I and II study of the MEK inhibitor Selumetinib given twice daily on 5 out of 7 days in~     children with NF1 and inoperable plexiform neurofibromas or progressive/relapsed optic~     pathway gliomas.~      This study will test the early and late toxicities of selumetinib when it is given in this~     intermittent schedule (in 5 out of 7 days) and will also test the effectiveness of the drug~     in reducing the size of plexiform neurofibromas and optic pathway gliomas in children with~     NF1. It will also test the effectiveness of the drug in improving the participants function~     in day to day life.~   "
18378|NCT03326375|"~     Comparison of Stereotactic Body Radiation Therapy (SBRT) and repeated transarterial~     chemoembolization (TACE) for Hepatocellular Carcinoma (HCC)as a Local Salvage Treatment after~     first incomplete TACE~   "
18379|NCT03326362|"~     Although it is known that chronic low back pain (CLBP) have a multifactorial etiology, the~     investigations about it are mostly specific to each investigation area, making difficult to~     understand this complex condition. The purpose of the study was to investigate CLBP from a~     multidisciplinary approach, analyzing biomechanical, morphological and inflammatory~     parameters aiming to compare the influence of two strength training protocols, one of low~     intensity and low volume (LIT) and one of high intensity and high volume (HIT). In both~     experiments, pain intensity and level of functional disability were analyzed (by analogue~     scale of pain and Oswestry Index), Ground Reaction Forces (GRF - AMTI BP600900 - 2000 force~     plate), kinematics of lower limbs (Inertial Sensors by Noraxon) and electromyography of the~     rectus abdominis, external oblique, lumbar multifidus, medial gluteus, vastus lateralis and~     biceps femoris muscles (TelemyoDTS) during gait and sit-to-stand, inflammatory cytokines by~     Multiplex in blood samples and cross-sectional area (CSA) of the lumbar multifidus by~     ultrasound imaging.~   "
18380|NCT03326349|"~     This study evaluates the effectiveness of Guttmann NeuroPersonalTrainer (GNPT), a~     tele-rehabilitation platform developed as a tool for the cognitive rehabilitation of chronic~     stroke patients. All patients will receive this treatment but in different order: half will~     receive GNPT and the other half will receive sham cognitive training; after a washout period~     of three months, crossover will occur and participants from the GNPT condition will receive~     sham cognitive training, while participants originally from the control intervention will~     receive GNPT.~   "
18381|NCT03326336|"~     The objective of this study is to evaluate the safety and tolerability of escalating doses of~     a gene therapy called GS030-DP (injected study treatment) administered via a single~     intravitreal injection and repeated light stimulation using a medical device called GS030-MD~     (stimulating glasses) in subjects with documented diagnosis of non-syndromic Retinitis~     Pigmentosa~   "
18382|NCT03326323|"~     Efficacy and safety assessment of of Acute Normovolemic Hemodilution and its influence on~     blood product usage, hemostatic markers, and amount of chest tube drainage at 24 hours post~     CABG surgery.~   "
18429|NCT03325712|"~     The primary objective of this trial is to investigate safety and tolerability of BI 705564 in~     healthy male subjects, following oral administration of multiple rising doses.~      Secondary objectives are the exploration of the pharmacokinetics, including dose~     proportionality and investigation of linearity.~   "
20197|NCT03302598|"~     A prospective study of 40 patients admitted with the diagnosis of enterocutaneous fistula and~     prepared for definite surgical repair in the form of resection anastomosis of ECF. The~     investigators used preoperative serum C-reactive protein as predicting factor to recurrence~     and independent variable for timing of surgery.~   "
18383|NCT03326310|"~     This is a phase I, open-label, dose-escalation study to determine the MTD of selumetinib when~     combined with the standard dose of azacitidine. Treatment will begin within 28 days of~     screening procedures. Treatment will continue indefinitely, provided that the patient~     continues to derive benefit. A patient will be taken off study for reasons described in~     detail in section 3.12 including disease progression, unacceptable toxicity, inter-current~     illness, withdrawal of consent, or at the discretion of the investigator. Patients will be~     followed for 12 weeks after the last dose of study drug, until any study treatment related~     toxicities have stabilized, or until death. The total duration of the study is expected to be~     approximately 24 months.~   "
18384|NCT03326297|"~     This study compares the effectiveness of manual therapy (osteopathy) on infant colic versus~     education to the family, and a third group with no specific intervention.~   "
18385|NCT03326284|"~     The primary aim of the trial is to determine the optimal dose of protein per meal in relation~     to enhancing muscle protein synthesis and thereby in perspective counteract muscle loss~     during weight loss. In addition, we aim to determine whether the response to protein intake~     is reduced in women on hypocaloric diet compared to in women on an energy-balanced diet.~   "
18386|NCT03326271|"~     Recent studies have indicated a high incidence of postoperative periprosthetic femoral~     fracture in elderly patients treated with two commonly used cemented polished, tapered~     femoral stems. The aim of this study was to compare the prevalence and incidence rate of PPF~     in a cohort of elderly with femoral neck fractures (FNF) treated with either a collarless,~     polished, tapered stem (Exeter) or an anatomic matte stem (Lubinus SP 2).~      Patients and Methods In a multicentre retrospective cohort study 2529 patients 60 years and~     above, with a FNF as indication for primary surgery with a cemented hip arthroplasty were~     included. Patients were treated either with a polished tapered Exeter stem or a matte~     anatomic Lubinus SP12 stem according to the surgeons preference or to the praxis of the~     present department.~      The incidence of perprosthetic femoral fractures Hip-related complications and repeat surgery~     were assessed at a minimum follow-up of 2 years postoperatively.~   "
18387|NCT03326258|"~     This phase Ib/II trial studies the best dose of glembatumumab vedotin when giving together~     with nivolumab and ipilimumab in treating patients with solid tumor that has spread to other~     places in the body and cannot be removed by surgery. Monoclonal antibodies, such as~     glembatumumab vedotin, nivolumab, and ipilimumab, may interfere with the ability of tumor~     cells to grow and spread.~   "
18388|NCT03326245|"~     Background:~      Dopamine (DA) is a chemical signal in the brain linked to learning, memory, and habits.~     Stimulant drugs like methylphenidate can increase DA in the brain. Researchers want to~     measure DA with and without this drug. They want to learn how methylphenidate and brain~     dopamine affect body responses, mood, and thinking.~      Objective:~      To better understand the role of dopamine in the brain and the effects of methylphenidate.~      Eligibility:~      Adults ages 18-55 who have used alcohol or stimulant drugs but have no drug dependence.~      Design:~      Participants will be screened with:~        -  Physical exam~        -  Question about medical, psychiatric, and alcohol and drug use history~        -  Questions to see if it s safe to have a PET/MRI scan~        -  Blood and urine tests~        -  Breath test for alcohol~      Participants will have 3 or 4 study visits. At each visit they will have:~        -  Urine and breath tested for alcohol and drugs~        -  A thin plastic tube (catheter) inserted in each arm by needle~        -  A small amount of radioactive chemical injected through the catheter.~        -  PET/MRI scan. Participants will lie still on a table that slides in and out of a metal~          cylinder surrounded by a strong magnetic field. Their vital signs will be monitored.~          They will get earmuffs for loud noises. Before the scan, participants will get the study~          drug or placebo through the catheter. They may also get a sugar pill (placebo). They~          will get a small meal and have blood drawn.~        -  Tests of memory, attention, and thinking.~      Participants will wear an activity monitor on the wrist for one week.~   "
18389|NCT03326232|"~     Gestational diabetes (GDM) is a condition of carbohydrate intolerance with onset or first~     recognition in pregnancy. The prevalence of GDM is as high as 25% in some populations and~     continues to rise with the increase in obesity and type-2 diabetes. GDM places the pregnancy~     at great risk to both the mother and the neonate. Recent studies have proven that~     interventions including dietary and medications lower the risk to the pregnancy. Both the~     American College of Obstetrics and Gynecology (ACOG) and the American Diabetes Association~     (ADA) recommend dietary interventions with daily glucose monitoring as the initial treatment~     of choice. Meanwhile, outside of pregnancy, promising new technologies such as continuous~     glucose monitors (CGM) are revolutionizing diabetic care. The investigators seek to determine~     if the constant feedback of a real-time CGM system would improve glycemic control compared to~     traditional management in GDM~   "
18390|NCT03326219|"~     A new technique, mechanochemical endovenous ablation (MOCA), using the ClariVein ® system is~     recently developed. To date, histopathological data after mechanochemical endovenous ablation~     are not known.~      The aim of this study is the histopathological analysis of venous injury using~     mechanochemical endovenous ablation.~   "
18391|NCT03326206|"~     Since 2009, a programmatic community-based strategy (COPE) has been implemented to address~     health disparities among Navajo individuals living with multiple chronic conditions. COPE~     (Community Outreach and Patient Empowerment) targets individual, family, and health~     system-level factors through four activities: 1) coordination between community health~     representatives (CHRs) and Indian Health Service providers; 2) CHR competency with~     standardized training; 3) a culturally-sensitive health promotion curriculum for patients and~     families; and 4) strong CHR supervision.~      COPE has been implemented throughout Navajo Nation. Enrollment is programmatic; in other~     words, the decision to enroll a patient in COPE occurs independently of whether the patient~     is in this study. Participants receive the COPE intervention in the same manner and~     intensity, whether they are included in this observational study or not.~      The main goal of this observational research is to understand if COPE improves the lives of~     participating community members. The Primary Aim is to assess the impact of the COPE Project~     on changes in HbA1c and other CVD risk factors. Hypothesis: Patients enrolled in the COPE~     program will experience a reduction in HbA1c compared to the control group. Secondary aims~     are: 1) To understand if COPE improves patients' own self-reported outcomes. Hypothesis: COPE~     patients will report better health compared with their own baseline at 12 months. 2) To~     Identify factors associated with increased effectiveness of the COPE Project at the~     individual, community, and health system level using a mixed-model approach. 3) To understand~     diverse stakeholder perspectives on COPE impact and value among CHRs, providers and the~     health care system. Hypothesis: Compared with baseline, CHRs will report greater empowerment~     in their work, providers will report greater confidence in CHRs.~      The observational cohort will be comprised of individuals with diabetes receiving care at one~     of the participating health facilities. Cases include individuals participating in the COPE~     intervention; controls are non-COPE participants identified within the same hospital and~     matched based on similar baseline characteristics. Study findings will improve clinical and~     patient-decision making and the health of marginalized AI/ANs by informing policies to~     promote CHR interventions in rural and underserved communities.~   "
18392|NCT03326193|"~     This is a Phase 2, open-label, single arm study to evaluate progression free survival rate at~     18 months as well as evaluating the safety and efficacy of niraparib in combination with~     bevacizumab as maintenance therapy in patients with advanced ovarian cancer patients who have~     received prior front-line therapy with platinum-based chemotherapy in combination with~     bevacizumab and who have had at least one prior attempt at debulking surgery. Niraparib is an~     orally active poly adenosine diphosphate-ribose (PARP) inhibitor. Niraparib will be~     administered by mouth once daily continuously during a 21-day cycle. Bevacizumab will be~     administered intravenously D1 of each 21-day cycle for up to 15 mos, including the duration~     of the front-line therapy. Health-related quality of life will be measured by Eastern~     Cooperative Oncology Group performance status (ECOG). Safety and tolerability will be~     assessed by clinical review of adverse events (AEs), physical examinations,~     electrocardiograms (ECGs), RECIST tumor assessments and safety laboratory values.~   "
18393|NCT03326180|"~     The clinical and cost effectiveness of peri-articular liposomal bupivacaine plus bupivacaine~     hydrochloride compared with bupivacaine hydrochloride alone for post-operative recovery after~     knee replacement surgery: A multi-centre, patient-blinded, randomised controlled trial.~   "
18394|NCT03326167|"~     Because of its availability, non-invasiveness, and high diagnostic performance, myocardial~     perfusion tomoscintigraphy has become a standard tool for the detection, characterization and~     monitoring of coronary artery disease. Standard analysis, based on the reversibility of~     regional myocardial hypoperfusion between stress (physiological or pharmacological) and rest,~     has good sensitivity and negative predictive value in the search for myocardial ischemia.~     However, two major obstacles persist. First, because of the relative nature of the~     normalization of cardiac activity, this approach may underestimate the extent of the damage,~     especially when the territory with the most activity is itself pathological. Thus myocardial~     perfusion scintigraphy can only detect 40 to 50% of tri-truncal patients. To overcome these~     disadvantages, several indexes have been proposed to improve the diagnostic performance of~     perfusion scintigraphy in multi-truncal patients based in particular on kinetic analysis.~     Secondly, the review does not provide any guarantee as to the quality and reproducibility of~     use of the coronal reserve during stress, in particular during submaximal stress tests and~     pharmacological stress, the latter being easily antagonized by xanthine derivatives contained~     in tea and coffee in particular (abstinence of at least 12 to 24 hours being recommended). In~     recent years and thanks to the advent of CZT semiconductor cameras dedicated to cardiology -~     to perform a dynamic tomographic acquisition - a study of the coronal reserve is feasible by~     perfusion tomoscintigraphy in current practice. This study of the coronary reserve mainly~     consists of a computer post-processing of the myocardial perfusion scintigraphy data and does~     not therefore require any additional irradiation (the only difference with respect to the old~     protocols is the start of the images at the time of publication. injection of the~     radiotracer). However, the diagnostic benefit gained from the coronary reserve study compared~     to conventional stress / rest perfusion scintigraphy has not been clearly studied,~     particularly in the multi-truncal patients.~   "
18395|NCT03326154|"~     The study aims to identify factors associated with no increase in gastrointestinal quality of~     life after elective cholecystectomy for gallstones.~   "
18396|NCT03326141|"~     The research team will conduct a 2 x 2 factorial experiment testing the individual and~     combined effects of two empirically and theoretically relevant sets of behavior change~     strategies on community-dwelling older adults' physical activity. To do this the~     investigators will randomize participants >= 70 years old (n = 308) to 1 of 4 experimental~     conditions. All conditions include an evidence-based physical activity protocol endorsed by~     Centers for Disease Control and Prevention (CDC) for use by all older adults, including those~     with frailty and multiple co-morbidities and the commercially available physical activity~     monitor (e.g., Fitbit) to augment intervention delivery. Intervention components that are~     experimental and vary by condition are the sets of behavior change strategies which will be~     combined with the physical activity protocol and the physical activity monitor. Condition 1~     has no specific behavior change strategies; Condition 2 includes an intervention component~     comprised of 5 interpersonal behavior change strategies, such as facilitating social support~     and social comparison; Condition 3 includes an intervention component comprised of 5~     intrapersonal behavior change strategies, such as setting personally meaningful goals; and~     Condition 4 includes both sets of behavior change strategies -- 5 interpersonal strategies~     combined with 5 intrapersonal behavior change strategies.~   "
18397|NCT03326128|"~     This study aims to investigate the benefit of administering Bupropion XL (BUP-XL) to heavy~     smokers who also experience psychiatric symptoms.~   "
18398|NCT03326115|"~     There is no known interventional clinical trial evidence for existing support and the~     reintegration strategy of a peer visitation program following amputation. The Amputee~     Coalition Peer Visitation Program is the only national and VA recognized program for~     amputees, however, it has not been rigorously tested for effectiveness. Therefore, the~     objective of this study is to demonstrate the Amputee Coalition Peer Visitation Program (AC~     PVP) will improve functional outcomes for Service Members, Veterans, and civilians during~     amputation rehabilitation.~   "
18399|NCT03326102|"~     The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of~     DHP107 (Oral Paclitaxel, Korea brand name: Liporaxel®) compared to IV Paclitaxel in patients~     with Recurrent or Metastatic Breast Cancer.~   "
18400|NCT03326089|"~     This is an interventional double-blind randomized controlled trial, to investigate the short~     and long-term effects of a supervised exercise training program in patients with IPF,~     depending on alternate patterns of oxygen supplementation during PR.~   "
18401|NCT03326076|"~     This is an observational study to evaluate safety and efficacy outcomes in renal transplant~     recipients in whom post-transplant care is managed using AlloSure®. AlloSure® is a~     non-invasive test to measure donor-derived cell-free DNA (dd-cfDNA). The AlloSure test is~     intended to assess the probability of allograft rejection in kidney transplant recipients~     with clinical suspicion of rejection and to inform clinical decision-making regarding the~     necessity of renal biopsy in such patients at least 2 weeks post-transplant in conjunction~     with standard clinical assessment.~   "
18402|NCT03326063|"~     The overall aim of the study is to determine the efficacy of oral ifetroban, a novel~     antagonist of T prostanoid (TP) receptors, as a treatment for patients with~     aspirin-exacerbated respiratory disease (AERD).~   "
18403|NCT03326050|"~     gemifloxacin versus ciprofloxacin and rifampicin in treatment of rhinoscleroma~   "
18404|NCT03326037|"~     Nephrotic syndrome (NS) represents one of the most common diagnoses in pediatric and adult~     nephrology, with a prevalence of 16 per 100,000 children and 3 per 100,000 adults in Western~     countries.~      In most cases, the pathogenesis of NS remains elusive, and the clinical phenotype of patients~     does not allow discrimination among different causes. Thus, children with NS are usually~     treated with corticosteroids before a biopsy is taken, and approximately 80% of them respond~     to such a treatment. According to this observation, pediatric NS has been separated into two~     broad categories; Steroid-Sensitive Nephrotic Syndrome (SSNS) and Steroid-Resistant Nephrotic~     Syndrome (SRNS). In both these categories the biopsy result is usually Minimal Change Disease~     (MCD) while a few may show Focal and Segmental Glomerulosclerosis (FSGS). Although children~     affected by SSNS have good long-term prognosis, most patients with SRNS progress to End Stage~     Renal Disease (ESRD) within 2-10 years of diagnosis .~      In adults a biopsy diagnosis of FSGS is more common than in children and more patients will~     not respond to corticosteroids alone and will need additional immunosuppressant medication.~     About 40% will progress to ESRD within 10 years .~      Currently, at least 19 genes have been clearly identified with association to SRNS harboring~     ~300 independent mutations, conferring a considerable genetic heterogeneity to the disorder.~      Genetic testing is emerging as a useful diagnostic tool in SRNS as it has implications for~     clinical course, treatment response, risk for posttransplant proteinuria and prenatal~     diagnosis. An approach for genetic testing based on the current evidence seems cost-effective~     and may help in the best possible management of SRNS .~      The NPHS2 gene, is located on chromosome 1 and is also known as the Podocin gene. It encodes~     the podocin protein. Podocin is a 383-amino acid lipid-raft-associated protein localized at~     the slit diaphragm, where it is required for the structural organization and regulation of~     the glomerular filtration barrier. Its interaction with other slit diaphragm proteins eg.~     nephrin, NEPH1, CD2AP and TRPC6 is important in mechanosensation signaling, podocyte~     survival, cell polarity, and cytoskeletal organization .~      It has been reported that variants in the NPHS2 gene are associated with NS .~      The commonly studied rs61747728 NPHS2 gene polymorphism also known as p.R229Q has been~     reported to be associated with NS and SRNS .~      However others have failed to report an association , which might be due to population~     differences.~      The rs61747728 is a non-synonymous variant found on exon 5 which is suggested to be involved~     in in altering the functional properties of podocin in vitro and possibly in vivo .~      The investigators will therefore investigate the frequency of the p.R229Q variant in Middle~     East patients with NS.~      Genetic analysis will have important implications in several aspects:-~        1. Understanding the biology of the disease in this part of the world.~        2. Counselling patients about their clinical course and what medication they will respond~          to.~        3. Counselling patients about the possibility of a kidney transplant sooner in their~          disease course~   "
18405|NCT03326024|"~     Long term assessment of ovarian reserve after more than two years of laparoscopic ovarian~     drilling in Polycystic Ovary Syndrome~   "
18406|NCT03326011|"~     The purpose of this study was to investigate the effects of gait training with the new~     wearable hip assist robot developed by Samsung Advance Institute of Technology (Samsung~     Electronics Co, Ltd, Korea) in patients with chronic stroke.~   "
18408|NCT03325985|"~     This is a two-arm, multi-site randomized controlled trial of 1,350 older adults (65+ years)~     with either advanced cancer (defined as metastatic solid tumor) or end-stage organ failure~     (New York Heart Association Class IV Heart Failure, End Stage Renal Disease defined as GFR <~     15 ml/min/m2; or oxygen-dependent chronic obstructive pulmonary disease (COPD)) who present~     to the Emergency Department (ED), along with 675 of their informal caregivers, to compare~     nurse-led telephonic case management to facilitated, outpatient specialty palliative care.~     Investigators will compare effectiveness of two distinct palliative care models that vary by~     provider type (nurse versus physician-led) and mode of delivery (telephonic versus~     in-person): a) nurse-led telephonic case management; and b) facilitated, outpatient specialty~     palliative care.~   "
18409|NCT03325972|"~     This is a randomized, prospective, double-blind , placebo-controlled trial examining the~     effects of intraoperative dexmedetomidine infusion on pain in patients undergoing lumbar~     spinal fusion surgery. One hundred ten subjects (55 in each arm) will be enrolled. Subjects,~     over the age of 18, undergoing lumbar spinal fusion will be considered eligible for~     enrollment. Subjects will receive either intraoperative dexmedetomidine or placebo of normal~     saline infusion. They will be followed for approximately six weeks postoperatively.~   "
18410|NCT03325959|"~     The investigators have previously studied the efficacy of hyperbaric oxygen therapy (HBOT) as~     a treatment for Fibromyalgia syndrome (FMS) in a prospective, active control, crossover~     clinical trial. The results demonstrated significant amelioration of all FMS symptoms, with~     significant improvement in life quality; furthermore, the investigators were able to~     demonstrate significant neuroplasticity on SPECT imaging, with a decrease of the~     hyperactivity in posterior regions and elevation of the reduced activity in frontal areas.~      In the proposed study, the investigators intend to both repeat and expand our previous~     findings, treating FMS patients with HBOT while performing an extensive of evaluation both~     before and after treatment.~      In the current study, the investigators plan to compare HBOT to current standard of care of~     FMS (pharmacological and non - pharmacological).~   "
18411|NCT03325946|"~     The VTCRI Neuromotor Research Clinic was established and opened in May of 2013 to provide~     intensive therapeutic services to individuals with motor impairment secondary to neuromotor~     disorders. It is direct by Dr. Stephanie DeLuca and based on the principles surrounding~     ACQUIREc Therapy.~      ACQUIREc Therapy is an evidenced-based approach to pediatric constraint-induced movement~     therapy, which refers to a multi-component form of therapy that is focused on helping~     children who have asymmetric motor abilities between the two sides of the body. Historically,~     ACQUIREc Therapy has the unimpaired or less impaired upper extremity constrained (by a cast~     or a splint) while also receiving active therapy from a specially trained therapist who~     shapes new skills and functional activities with the child's more impaired upper extremity~     but who is also a licensed Occupational or Physical Therapist (OT/PT). Therapy dosages are~     high much higher than tradition OT or PT - often lasting many hours per day, up to 6 hours a~     day, 5 days a week, for 2-4 weeks.~      Investigators have developed further treatments based on the same principles of intensive~     services combined with behavior shaping for other areas of the body that are also affected by~     weakness (e.g., the leg and trunk) also, but which usually do not involve constraint. These~     have been more generally labeled ACQUIRE Therapy.~      All forms involve intensive, play-based therapy for children with asymmetric motor~     impairments of the arms and hands. The primary focus of treatment is to facilitate the~     acquisition of new motor skills in the child's weaker body parts through high levels of~     intensive therapy using scientifically-based behavioral guidelines. Therapy is also delivered~     in naturalistic environments.~      ACQUIREc Therapy as a treatment method has been tested in two randomized controlled trials,~     and a specific manual for its implementation has been developed. Dr. (s) Ramey and DeLuca~     previously founded a similar clinic, The Pediatric Neuromotor Research Clinic, at the~     University of Alabama at Birmingham where Dr. DeLuca directed the research clinic for 13~     years and oversaw the implementation of the ACQUIREc Therapy treatment protocol in more than~     400 cases.~      This research will involve analyzing and interpreting the clinical data of children going~     through clinical procedures at the VTCRI Neuromotor Research Clinic. All participation is~     voluntary and no children will denied services if families choose not to participate.~   "
18412|NCT03325933|"~     This study will investigate the relationship between resistance training load and repetitions~     on cardiometabolic outcomes. The primary objective of this clinical trial is to determine~     whether high load or low load resistance exercise training affects arterial stiffness in~     overweight or obese men and women. Our secondary objectives are to investigate the effects of~     high and low load RT on vascular function, cardiac structure, and markers of insulin~     sensitivity. Finally, we are going to preliminarily explore the effects of resistance~     training on intestinal bacteria.~   "
18413|NCT03325920|"~     This study aims to validate a new diagnostic method for quantification and monitoring of~     sleep bruxism.~   "
18414|NCT03325907|"~     This study evaluates the feasibility of three-dimensional printed template in transthoracic~     pulmonary nodule biospy. Investigator planned to include 20 patients with lung nodule biopsy~     schedule to receive template-guided transthoracic needle aspiration.~   "
18415|NCT03325894|"~     The purpose of the study is to evaluate the long-term safety and tolerability of SHP465 at~     6.25 milligram (mg) in children aged 4 to 12 years diagnosed with~     Attention-Deficit/Hyperactivity Disorder (ADHD).~   "
18416|NCT03325881|"~     The purpose of this study is to evaluate the efficacy and safety of SHP465 at 6.25 mg in the~     treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children aged 6-12 years.~   "
18417|NCT03325868|"~     Adenomyosis affects approximately 21% of symptomatic women who present to gynecology clinics.~     The disease is characterized by heavy bleeding and pain during periods. Limited treatment~     options exist for the treatment of adenomyosis for women who desire future child-bearing or~     prefer to avoid surgery. Recently, ulipristal acetate has been studied as a treatment option~     for women who have fibroids and heavy bleeding. The majority of women treated with ulipristal~     stopped having periods altogether. Our study aims to determine whether ulipristal is an~     adequate treatment for women with adenomyosis.~   "
18418|NCT03325855|"~     A national data registry of patients receiving fecal microbiota transplantation (FMT) or~     other gut-related-microbiota products designed to prospectively assess short and long-term~     safety and effectiveness~   "
18419|NCT03325842|"~     The Activities Scale for Kids performance (ASKp) is one of the few self-assessment~     questionnaires in pediatric rehabilitation that measures child perception in performance of~     daily routine activities. ASKp is composed of 30 questions designed to explore activities and~     participation in children and teenagers with musculoskeletal disorders. Scores assess level~     of physical ability, identify appropriate treatment and monitor changes over time. We~     recently undertook the cross-cultural validation to achieve a culturally adapted Italian~     version of ASKp: the Italian version is now to be tested on Italian children.~   "
18420|NCT03325829|"~     To determine the clinical characteristics and risk factors for the onset of diverticular~     disease and its complications in the Italian population.~   "
18421|NCT03325816|"~     This research study is being done to assess the safety and tolerability of study drugs,~     177Lu-DOTA0-Tyr3-Octreotate (Lutathera) and nivolumab in subjects with small cell lung cancer~     or advanced or inoperable neuroendocrine tumor of the lung that has overexpressed~     somatostatin receptors (SSRT). Lutathera is an investigational radioactive agent that targets~     tumor cells that express SSRT. Nivolumab is an investigational agent that targets and~     inhibits a pathway that prevents your immune system from effectively fighting your cancer.~     The combination of these 2 study drugs is investigational. The term Investigational in this~     context means that the drugs have not been approved for clinical use by the US Food and Drug~     Administration (FDA).~      Giving Lutathera and nivolumab together may increase the effectiveness of this therapy. We~     first need to find out the highest dose of Lutathera that can be given safely together with~     nivolumab. This study will be the first study to test giving Lutathera together with~     nivolumab. Once we have found the highest dose of Lutathera that can be given with nivolumab,~     we will treat more patients with this combination to determine how effective it is.~      The purposes of this study are:~      To find the highest doses of Lutathera that can be given with nivolumab without causing~     severe side effects.~      To find out the side effects seen by giving Lutathera at different dose levels with~     nivolumab.~      To determine if the amount of something in your tumor called PD-L1 makes you more likely to~     have a response to the combination of Lutathera and nivolumab.~   "
18422|NCT03325803|"~     Er:YAG ablative fractional laser-assisted photodynamic therapy (AFL-PDT) has shown~     significant benefit for the treatment of actinic keratosis(AK). Er:YAG ablative fractional~     laser ablates the epidermis and dermis without significant thermal injury, creating~     microscopic ablation zones (MAZ) in the portion of the skin that the laser is applied to. The~     formed MAZ depends on the laser parameters such as laser depth, laser density and laser~     passes, which affect the treatment outcome.~   "
18423|NCT03325790|"~     This study will evaluate the safety, efficacy, and PK of two dose levels of SPI-1005~     administered for 28 days compared to placebo in patients with Meniere's disease.~   "
18424|NCT03325777|"~     Tobacco use is the most preventable cause of disease, disability, and death in the United~     States. Standard smoking cessation care (cognitive behavioral therapy and nicotine~     replacement therapy), is effective in approximately 20% of the cases, clearly indicating~     there is substantial room for improvement.~      Current work suggests that despite standard interventions, continued substance abuse may~     result from addictive behaviors governed partly through automatic processes that exert their~     influence outside conscious control. This is important from a treatment perspective, as we~     should develop treatments to target implicit processes.~      Among a number of promising targets for intervention, cognitive biases are important to~     address as they have been implicated as maintenance factors for addiction. Approach bias,~     defined as the automatically activated action tendency to approach smoking-related stimuli,~     is a relatively novel cognitive bias and has been related to failed smoking cessation. A~     recently developed task for approach bias assessment is the Approach Bias Retraining (ABR), a~     computerized joystick task increasingly used to measure automatic approach tendencies in~     addiction research.~      This clinical trial will evaluate a smoking cessation intervention that integrates standard~     care with approach bias retraining. Results will provide novel information regarding the~     potential benefits of engaging implicit cognitive biases as a means to augment traditional~     smoking cessation therapy. This study has the potential to help individuals attempting to~     quit smoking and, ultimately, provide unique information about the importance of targeting~     implicit processes to complement standard care.~   "
18425|NCT03325764|"~     This study aims to describe the effects of sleeve gastrectomy, the most commonly performed~     bariatric procedure worldwide, on functional capacity, habitual physical activity, physical~     fitness (cardiorespiratory and muscular fitness) and gait parameters in severely obese~     subjects undergoing bariatric surgery. Functional capacity, physical activity, physical~     fitness and gait parameters will be objectively assessed and compared among two groups of~     patients: candidates seeking sleeve gastrectomy (PRE group, n=30) and patients 6 months after~     sleeve gastrectomy (POST group, n=30).~   "
18426|NCT03325751|"~     Perimetry is a well-established method that is used to measure the visual field functions of~     humans. Commercially available products, such as the OCTOPUS 900 (Haag-Streit AG, Koeniz,~     Switzerland), are commonly used for assessing the visual field. Such devices are of critical~     value for patients suffering of glaucoma and neuro-ophthalmic conditions. The operating~     principle is to sequentially present light stimuli of different intensity at different~     locations within the visual field in an automatic way. Algorithms that select what locations~     and intensities to present over time are called strategies. These have the goal to provide~     both a fast and accurate estimation of the visual field function.~      Recently, new strategies were developed that are faster and equally accurate as the~     strategies used today. The technological advancement of these new methods lies primarily in~     the ability to estimate location sensitivities without observing them directly but by~     leveraging previously queried locations. For this the investigators plan to implement the~     next generation of perimetry strategies into an OCTOPUS 900 and to test it in healthy~     subjects and glaucoma patients.~   "
18427|NCT03325738|"~     Localized cutaneous squamous cell carcinoma (CSCC) is usually treated by radical surgery with~     or without radiotherapy. The cure rate is high around 90% of cases (1). Unresectable CSCC~     represents less than 10% of all CSCC. The prognosis of these advanced forms is poor, without~     any proven treatment option. The number of studies investigating systemic treatment of~     advanced or metastatic CSCC is limited, mostly based on phase II trials or case reports.~     Systemic treatment includes cytotoxic chemotherapy such as cisplatin and 5-Fluoro-uracil~     (5FU), immunotherapy (interferon alpha) or retinoic acid (13CRa) (1,2). Recently, epidermal~     growth factor receptor (EGFR) targeting agents have been explored (1,2). The anti-EGFR~     monoclonal antibody Cetuximab has shown some clinical efficacy in advanced CSCC alone or~     concomitant with radiotherapy or chemotherapy (3-5). A recent phase II study aimed at~     investigating the role of Cetuximab in 36 patients with unresectable CSCC (6). The authors~     reported a disease control rate at 6 weeks of 69% (95% CI, 52% to 84%). The best responses~     were eight partial responses and two complete responses. There were no Cetuximab-related~     deaths. There were three related serious adverse events: two grade 4 infusion reactions and~     one grade 3 interstitial pneumopathy. Grade 1 to 2 acne-like rash occurred in 78% of patients~     and was associated with prolonged Progression Free Survival (PFS) (6). The authors concluded~     that regarding the Cetuximab therapeutic index it could be interesting in this particular~     situation mainly for elderly patient. Unfortunately, the small number of patient included not~     allowed to draw definitive conclusion. It was interesting to note that the Disease rate~     control (DRC) with Cetuximab increased of 15% comparatively of DRC with chemotherapy.~     Additionally it seems that in case of efficacy the functional improvement of~     Cetuximab-sensitive patients occurred after very few infusions.~      Taking these data together it seemed logical to design a larger retrospective clinical trial~     to confirm these results in real life patients.~   "
18430|NCT03325699|"~     This multicentre randomized control trial aims to evaluate the effects of an intervention~     consisting of an health application developed to improve the quality of life (QoL) in older~     people with mild dementia and their informal caregivers. The study is a collaboration between~     five European countries where the clinical trials will be conducted in four of these~     countries (Sweden, Belgium, Spain and Czech Republic).~      In total 1200 dyads (consisting of a person with mild dementia (PWD) and their informal~     caregiver (carer) will be recruited for this study. Participant dyads will be randomized in a~     1:1 ratio in two parallel groups: PWD to receive either usual care from primary or~     specialized providers (control group) or to receive usual care plus access to a tablet with~     the SMART4MD health application (intervention group).~      Participants in the trial will be assessed for a period of 18 months. After the baseline~     visit, all participants will have follow-up visits every 6 months together with a checkup of~     the PWDs capacity to remain in the study. In the follow up visits, investigators will assess~     the PWD's quality of life, their cognitive and functional status, adherence to prescribed~     medication and attendance at healthcare appointments and admissions to healthcare services~     institutions. Investigators will also assess the burden of the informal caregivers.~   "
18431|NCT03325686|"~     This study was performed to evaluate the efficacy of weekly vitamin D supplementation on~     athletic performance in Iranian athletes~   "
18432|NCT03325673|"~     This study will evaluate the increase in comfort and comfortable contact lens (CL) wear time~     associated with application of TrueTear (active intranasal neurostimulation) compared with~     application of TrueTear sham control (intranasal application which is not electrically~     active) in symptomatic CL wearers.~   "
18433|NCT03325660|"~     Background: Urinary incontinence is common in men following prostate cancer surgery.~     Conservative treatment incorporates pelvic floor muscle exercises, biofeedback, electrical~     stimulation, lifestyle changes, or a blend of strategies. Little is thought about the~     physiologic impacts of entire body vibration practice on people body. The aim of the current~     study is to determine the effect of the whole body vibration and pelvic floor exercises on~     urinary incontinence following prostate cancer surgery. Methods: 61 patients were divided~     randomly into two groups. Group (1) included 30 patients participated in synchronous~     whole-body vibrations, 3 times weekly for 4 consecutive weeks; the frequency and peak-to-peak~     displacement of vibration were 2 mm/20 Hz for the first week for 5 minutes, 3mm/25 Hz, 10~     minutes for the second week and 4 mm/30 Hz, 15 minutes for the last two weeks. Group (2)~     included 31 patients received only pelvic floor exercises. The intervention in both groups~     was for three times per week for four weeks. The outcome measures were urodynamic~     measurements for pressure at maximum flow rate and maximum flow rate. Also, patients were~     instructed to complete 2 questionnaires; incontinence visual analogue scale (I- VAS) and the~     international consultation of incontinence-short form. Results: When comparing between pre-~     treatment and post treatment for group 1 the results revealed that there were significant~     differences including all test parameters, while the results of group 2 showed non-~     significant differences including all test parameters except for the pressure at maximum flow~     rate which showed a significant difference from the baseline data (P> 0.05. It was revealed~     that there were significant differences when comparing the results of all test parameters~     after the treatment protocol in favor of group 2 (P> 0.05). Conclusion: It can be concluded~     that the whole body vibration is a simple training and has a good effect in treating the~     patients with urinary incontinence after radical prostatectomy.~   "
18434|NCT03325647|"~     This research study in infant males with Klinefelter syndrome (47,XXY) will learn more about~     the effect of testosterone on early health and development. The study is a total of three~     visits over 6 months with assessments of motor skills, body composition (muscle and fat), and~     hormone levels. This is a randomized, placebo-controlled study but all infants will receive~     testosterone treatment during the study period. The investigators will learn how testosterone~     treatment in infancy effects short term outcome measures on health and development.~   "
18435|NCT03325634|"~     This phase I trial studies the side effects and best dose of stereotactic body radiation~     therapy in treating patients with ovarian or uterine cancer that has come back. Stereotactic~     body radiation therapy is a specialized radiation therapy that sends x-rays directly to the~     tumor using smaller doses over several days and may cause less damage to normal tissue.~   "
18436|NCT03325621|"~     Anticalin® proteins are engineered human proteins that are able to bind specific target~     molecules. The Anticalin PRS-080#022-DP to be investigated in this study is directed against~     hepcidin and is intended for the treatment of anemia of chronic disease. This pilot Phase 2a~     study shall investigate the safety, pharmacokinetics and pharmacodynamics of repeated~     administrations of PRS-080#022-DP in anemic stage 5 chronic kidney disease (CKD) patients~     undergoing hemodialysis.~   "
18437|NCT03325608|"~     Dementia is a common problem for older patients presenting to emergency departments and for~     the family caregivers who often lack support, understanding, and skills to manage the~     problems related to the need for emergency department visits. The purpose of Program of~     Intensive Support in Emergency Departments for Care Partners of Cognitively Impaired Patients~     (POISED-CPCIP, here on referred to as POISED) randomized controlled trial is to use~     previously established quality improvement methods of root cause analysis to uncover reasons~     for emergency department use and to focus on caregiver activation within a program of~     dementia care management.~      The goals of this study are to reduce recurrent emergency department visits and improve~     caregiver symptoms of depression, anxiety and need for social support.~   "
18438|NCT03325595|"~     The study is designed to evaluate the safety, tolerability, pharmacokinetics (PK) and~     pharmacodynamics (PD) of escalating single oral doses of AEF0117 in healthy adult male and~     female subjects.~   "
18439|NCT03325582|"~     Perianal Crohn's disease (pCD) is the commonest form of fistulising Crohn's disease, with up~     to 38% of patients affected and with 30% of them experiencing recurring disease symptoms.~     Presence of fistula can lead to major morbidity due to cutaneous perianal abscess formation~     or drainage.~      To date, it is very difficult to quantify inflammation in patients with pCD due to the~     absence of reliable disease activity measurements. In addition to this, optimising therapies~     for pCD is quite challenging and may have a major impact on quality of life. Magnetic~     resonance imaging of pelvic is a standard examination for the anatomical evaluation of pCD~     which is significant in terms of surgical therapy and progress. The overall hypothesis is~     that newer MRI techniques such as magnetization transfer (MT), diffusion weighted image (~     DWI) and dynamic contract enhancement (DCE) are better suited to measuring the inflammatory~     vs fibrotic burden in pCD. The aim of this project is to measure disease activity within pCD~     and luminal CD using MRI sequences before and after biological therapy~   "
18451|NCT03325426|"~     The study aims to determine if use of physical activity trackers coupled with provider~     feedback will increase awareness of young adults of their physical fitness and improve blood~     pressure levels. The goal of this pilot study is feasibility, with a secondary goal of~     examining potential effect sizes for planning purposes for a larger randomized controlled~     trial.~   "
18440|NCT03325569|"~     Women with PCOS are more prone to obesity which exacerbates insulin resistance, the abdominal~     fat disposition and metabolic risk of these patients. With development of obesity these women~     have high conversion rate from normal glucose tolerance to impaired glucose tolerance and in~     turn to type 2 diabetes.~      Glucagon-like peptide 1 (GLP-1) is involved in body weight maintenance. Beside energy balance~     it is also involved in glucose homeostasis. Functional deficit in GLP-1 facilitates obesity.~     We investigated the link between the concentration of incretin hormones and glucose~     homeostasis, metabolic complications and the distribution of body composition in obese women~     with PCOS.~   "
18441|NCT03325556|"~     The purpose of this study is to evaluate the efficacy of pimavanserin by comparing~     pimavanserin with placebo in preventing a relapse of psychotic symptoms in subjects with~     dementia-related psychosis and who were stabilized after 12 weeks of open label pimavanserin~     treatment.~   "
18442|NCT03325543|"~     The pelvic floor muscle training (PFMT) is a conservative treatment, currently considered as~     first line for women with stress urinary incontinence (SUI). However, in practice, about 30~     to 50% of women are unable to perform the correct contraction of the pelvic floor muscles~     (PFMs). When requested to perform the muscle contraction, the contraction of the gluteal~     muscles, hip adductors, or abdominal muscles is observed initially, rather of contraction of~     the levator anus muscle. Some factors make it difficult to perform the contraction of the~     PFM, such as its location on the pelvic floor, and its small size, followed by a lack of~     knowledge of the pelvic region, as well as its functions. Associated with these factors is~     the use of the muscles adjacent to the PFM, as previously mentioned. In order for women to~     benefit from a PFMT program for the treatment of SUI, the awareness phase of PFM can't be~     omitted, since the literature is unanimous in stating that pelvic exercises improve the~     recruitment capacity of the musculature, its tone and reflex coordination during the effort~     activities.~   "
18443|NCT03325530|"~     To measure impact of improved healthy food access and physical activity opportunities at~     summer Boy Scout camp, a four-week intervention to address nutrition and physical activity~     with youth (n=911) and adults (n=247) was conducted at Bashore Scout Reservation in~     Jonestown, Pennsylvania between June and July of 2016. Intervention components included~     dining hall menu modifications, healthy messaging, introduction of nutritious snacks~     available for purchase, and a physical activity challenge.~      Menu modifications resulted in improved satisfaction scores related to portion sizes (+28%)~     and variety (+14%), decreased plate waste, and consistent food costs. Introduction of~     nutritious snacks at Trading Post resulted in increased satisfaction (+13%) and increased~     sales per person (+20%). Physical activity increased (+22%) as a result of a step competition~     between troops. Small changes towards a healthier camp were widely accepted and successful,~     indicating potential for translation to other camps within the organization.~   "
18444|NCT03325517|"~     BACKGROUND:~      The 243 amino acid E1A encoded by the left end of the human adenovirus (Ad) type 2 or 5~     genome has been studied in various contexts including as a model cooperating oncoprotein , an~     apoptosis inducing protein, and as a therapeutic oncolytic protein. All of these properties~     are associated with its capacity to rapidly induce S phase in a variety of cells. E1A~     orchestrates most of these effects by interacting with an array of chromatin remodeling~     complexes, including the Rb family proteins, and the HAT proteins p300 and CBP.~      The Myst family protein HBO1 (Myst2, KAT7) is a histone acetyl transferase that plays a major~     role in replication initiation and also contributes to DNA re-replication. HBO1 directly~     interacts with Cdt1 and functions as a coactivator of Cdt1 in replication initiation. It also~     associates with replication origin and stimulates origin activation by acetylating H4 K5, K8,~     and K12. Overexpression of HBO1 induces DNA re-replication.~      SPECIFIC AIM OF THE STUDY: The Specific Aim of this study is to determine whether or not the~     stimulation of HBO1 activity by E1A plays a role in deregulated DNA replication, and if it~     does, to determine the mechanism.~        1. Using standard assays the investigators will determine whether E1A binds to HBO1 to~          induce its HAT activity~        2. The investigators will determine whether E1A stimulation of HAT activity of HBO1~          contributes to DNA re-replication.~      RESEARCH DESIGN AND METHODS:~      First, the investigators will determine whether E1A associates with replication origins and~     whether this association requires HBO1. The investigators will use the MCM4 origin which maps~     in the intergenic region between PRKDC and (Protein Kinase, DNA-Activated, Catalytic~     Polypeptide) and MCM4 genes.~      The investigators will transfect U2OS cells with plasmids expressing relevant proteins then~     determine their occupancy in origin sequences using ChIP assays. Plasmids expressing epitope~     tagged WT HBO1 or mutant derivatives along with plasmids expressing WT or mutant E1A proteins~     will be expressed in U2OS cells, then occupancy of these proteins on origin regions will be~     quantified using antibodies as appropriate. Typically in these experiments, using relevant~     antibodies, ChIP assays are performed with primer pairs encompassing origin regions and also~     regions that are far from origin. Occupancy of initiation factors are increased several fold~     in the origin region as compared to that of 2KB upstream or downstream regions. Loading of~     MCM complex along with Cdt1 onto the origins is an indication that initiation of replication~     occurs in that origin and usually assayed in ChIP-re-ChIP assays as follows: First, loading~     of HBO1 to the origins will be confirmed using epitope specific antibodies in the first ChIP.~     The anti-HBO1 precipitates will be re-ChIPed with anti-MCM3 antibodies. Loading of MCM3~     helicase to origins occurs after Cdt1 binding and depends on HBO1 HAT activity. Normal~     amounts of MCM3 will be detected after re-ChIP-ing in E1A+ control samples. If reduced amount~     of MCM3 is recovered in reChIP assays when mutant E1A or HBO1 mutant (e.g. HBO1 G435A) is~     used, it would indicate that stimulation of HAT activity by E1A is critical for maximal~     origin activity in E1A+ cells. This type of assay has considerable flexibility in that mutant~     proteins can be rapidly assayed. This ChIP-reChiP assays will repeated in different~     combinations to determine the E1A loading.~      These results will be extended to virus infection assays. G1 specific cells isolated by drug~     treatment will be infected with Ad vectors expressing epitope tagged proteins as appropriate.~     Association of E1A and HBO1 and their mutant derivatives will be determined. This assay will~     allow us to confirm the effect of E1A stimulated HAT activity in origin firing and study the~     effects of E1A on origin firing, if any, other than increasing the HAT activity of HBO1.~   "
18445|NCT03325504|"~     ORTHOUNION is a multi-centre, open, comparative, randomized, clinical trial with three~     parallel arms that aims to compare the efficacy of three treatments to enhance bone healing~     in patients with long bone non-union.~   "
18446|NCT03325491|"~     As people grow older skeletal muscle gradually becomes smaller and weaker, causing reduced~     mobility and quality of life. To understand and reverse this negative process investigators~     need to find new ways of improving the ability of muscle to perform physical activity. There~     is some evidence that supplements may improve how the mitochondria work, and investigators~     want to explore this idea in more detail. This is possible by measuring how the muscles work~     and respond to exercise before and after taking the supplement alongside an aerobic (i.e.~     cycling) and resistance (i.e. weight lifting) exercise programme. This will give us the basic~     information investigators would need to see if this is a useful idea.~   "
18447|NCT03325478|"~     Background: For 40 years, brief contact interventions (BCIs) have been presented as promising~     approaches in suicide prevention but patient's experiences of BCIs are less investigated.~      Aim: Understand mechanisms of BCIs after suicide attempt, through patient's experience of a~     French BCI Stay in contact and assess its impact on seeking care during suicidal crisis.~      Method:This is a single-center, non-interventional, prospective qualitative study using phone~     call interview on a BCI, 6 months after suicide attempt behavior.~      Statistical analysis~      Data were analyzed using statistical software (Version 9.4, SAS Institute Inc., Cary, North~     Carolina, USA). Chi-squared test was used to assess qualitative variables and t-test to~     evaluate quantitative variables, with p<.05 considered significant.~   "
18448|NCT03325465|"~     The KEO study is a single arm phase II trial including 44 patients with T1N1-2B, T2N0-N2B~     head and neck squamous cell carcinoma (HNSCC) eligible for curative-intent resection (+/-~     adjuvant therapy), who receive neo-adjvuant pembrolizumab + epacadostat.~      The primary objective of this study is to determine rate of major treatment effect (MTE) to~     neoadjuvant pembrolizumab+epacostat immunotherapy in SCCHN compared to historic data with~     neoadjuvant pembrolizumab alone.~   "
18449|NCT03325452|"~     Incidence of non-hospital cardio-respiratory arrest (ACR) in France is around 40 000 cases~     per year, with mortality remaining very high, with 75% of patients dying before arrival in~     hospital. The investigators know some validated predictive factors for recovery of~     spontaneous cardiac activity (RACS) such as age, no flow (time between ACR and onset of CPR),~     type of initial electrical activity (FV, TVSP), or the value of CO2 expired.~      However, the use of these prognostic criteria in the conduct of CPR maneuvering is in~     practice limited. Lactate is now a well-known prognostic biological marker used in many~     pathological conditions such as shock states or the severe traumatized patient. Some data~     have also demonstrated the prognostic value of lactate on morbidity and mortality after ACR~     after resumption of spontaneous cardiac activity.~      The hypothesis of our study is that the evaluation of the initial lactate in the early~     cardiopulmonary resuscitation could be a prognostic factor of RACS.~   "
18450|NCT03325439|"~     The purpose of the study is to evaluate the pharmacokinetics (PK) of brivaracetam (BRV) in~     neonates who have seizures that are not adequately controlled with phenobarbital (PB)~     treatment and to identify the optimal BRV dose (Exploratory Cohort) for the treatment of~     subjects enrolled into the Confirmatory Cohorts of this study~   "
20342|NCT03300713|"~     The originality of the MOCITRAINING study lies in the integration of infant and maternal care~     during the pediatric consultation and the assessment of the impact of this type of care in~     the short and medium term on The MOCITRAINING program could contribute to improving the~     quality of parent-child interactions.~   "
18452|NCT03325413|"~     The focus of this study is the development of a perioperative treatment concept for elderly~     patients, based on individual necessities and risk factors, aiming to improve patient~     outcome. The planned interventions include preoperative screening for malnutrition, frailty~     and uncalled-for long-term medication, if required followed by early prophylaxis and~     treatment of these risk factors, prior to or during surgery.~   "
18453|NCT03325400|"~     Objectives. Toothpaste contains many potentially harmful ingredients, including some that can~     lead to serious long-term health problems. Everyday use of oral health care products has~     increased, highlighting the need for healthcare clinicians and consumers to be informed of~     the potential benefits and risks associated with these products. The aim of this study is to~     evaluate possible DNA damages to oral epithelial cells in participants exposed to toothpaste~     containing fluoride as opposed to the effects of non-fluoride toothpaste.~      Materials and Methods. Forty volunteers were selected among students of dental medicine and~     assigned into two experimental groups. Each group used regular non-fluoride toothpaste for~     initial two months, followed by the use of fluoride toothpaste of the same brand for the next~     two months. The buccal epithelial cells were sampled at baseline and 30, 60, 90 and 120 days~     after the beginning of the research. Chromosomal damages were analyzed by micronucleus assay.~   "
18454|NCT03325387|"~     The purposes of this study are to determine:~        -  The safety of LY3305677 and any side effects that might be associated with it.~        -  How much LY3305677 gets into the bloodstream and how long it takes the body to remove it~          in healthy participants, including those of Japanese origin.~        -  The effect LY3305677 has on the body, particularly the effect on blood glucose levels.~      This study will last approximately 17 weeks not including screening. Screening is required~     within 4 weeks prior to start of the study.~      This study is for research purposes only and is not intended to treat any medical conditions.~   "
18455|NCT03325374|"~     The research focuses on Cauda Equina Syndrome (CES) which describes damage to the nerves in~     the lower back which supply bladder, bowels, sexual function and the legs usually from~     slipped discs in the spine.~      CES is as common as multiple sclerosis and is diagnosed using an MRI scan of the spine, 'scan~     positive' CES. However, about 50% of people presenting with the symptoms of CES have MRI~     scans which do not explain their symptoms, 'scan negative' patients. The BLB study will be~     the first large clinical study comparing patients with 'scan positive' and 'scan negative'~     CES. All patients admitted to the Western General Hospital, Edinburgh with possible CES will~     be invited to participate. The study consists of detailed history taking, examination and a~     questionnaire following up patient's symptoms at three months.~      The study aims to see what differences exist between the 'scan positive' and 'scan negative'~     groups, help doctors understand more about the outcomes of both groups and discover the~     number of patients with 'scan negative' CES who have functional disorders (previously called~     medically unexplained or conversion disorders) or undiagnosed neurological disorders.~   "
18456|NCT03325361|"~     Anastomotic leakage (AL) is considered the commonest major complication after surgery for~     rectal cancer. Transanal tube drainage role in the prevention of AL is still debatable.~   "
18457|NCT03325348|"~     OBJECTIVE: To determine the efficacy of nifedipine and labetalol in terms of control of BP in~     pre eclamptic pregnant patients~      Design: Randomised control trial~      SETTING: Department Obstetrics & gynaecology, Services Hospital, Services Institute of~     Medical Sciences. Lahore~      POPULATION: Pregnant patients with BP 160/110 or symptoms of severe preeclampsia~      METHODS: Patients are randomised to receive nifedipine (10 mg tablet, orally, up to five~     doses) and intravenous placebo saline injection or intravenous labetalol injection (in an~     escalating dose regimen of 20, 40, 80, 80 and 80 mg) and a placebo tablet every 15 minutes~     until the target blood pressure of ≤140/90mmHg is achieved. Crossover treatment is given if~     the initial treatment regimen is unsuccessful~   "
18458|NCT03325335|"~     Pre-anesthetic dosing of midazolam is commonly used in many hospitals for the induction of~     anesthesia, but the effect is still controversial. The purpose of this study was to evaluate~     the effectiveness of midazolam premedication in four aspects: anxiety reduction, pain relief,~     sedation and hemodynamic stability.~   "
18459|NCT03325322|"~     The proposed studies will examine the effect of fisetin on adipose tissue-derived mesenchymal~     stem/stromal cell function, kidney function, markers of inflammation, and physical function~     in individuals with advanced chronic kidney disease.~   "
18460|NCT03325309|"~     The purpose of this study is to determine whether a home-based cycling program for patients~     with lumbar spinal stenosis is a feasible and acceptable~   "
18461|NCT03325296|"~     This clinical trial attempts to investigate the efficacy of LEO 124249 ointment in the~     treatment of alopecia areata on the eyebrows.~   "
18462|NCT03325283|"~     The PROTEMBO SF Trial is a prospective, observational, multi-center, intention-to-treat study~     of the safety and feasibility of the ProtEmbo Cerebral Protection System in subjects with~     severe symptomatic native aortic valve stenosis indicated for TAVR.~   "
18463|NCT03325270|"~     Rationale:~      According to the WHO, iron deficiency is still the most common and widespread nutritional~     disorder in the world. Current iron supplements have limitations in terms of bioavailability~     and tolerability. Prebiotic fibers, such as galacto-oligosaccharides (GOS), selectively~     enhance growth of beneficial colonic bacteria. Prebiotics in general enhance the production~     of short-chain fatty acids (SCFAs) and thereby decrease luminal pH. Through the reduction in~     colonic pH, prebiotics can enhance absorption of minerals such as calcium and magnesium and~     they have been proposed to potentially improve iron absorption as well.~      The primary objective of this study is to investigate the effect of an addition of GOS to an~     iron supplement on iron absorption in iron deplete, healthy, normal weight women.~   "
18464|NCT03325257|"~     Nivolumab obtained European Marketing authorization in June 2015. Before this date, a~     Temporary Authorization for Use (ATU) Program in France for nivolumab was set up between~     September 2014 and August 2015. This program enrolled approximately 600 melanoma patients~     (unresectable or metastatic).~      It appears relevant to conduct a study on patients treated during the ATU to assess~     thoroughly patient characteristics, efficacy, safety, and patterns of use of nivolumab in~     real-life conditions.~   "
20724|NCT03295734|"~     The purpose of this project is to conduct a randomized, controlled trial (RCT) to determine~     if choice of antihypertensive medication influences changes in functional status and other~     cardiovascular risk factors among older persons with hypertension when combined with physical~     exercise.~   "
18465|NCT03325244|"~     Residency training requires hospital presence twenty-four hours a day. At times this~     necessitates working extended shifts, including night shifts, resulting in altered sleep~     patterns and sleep deprivation. Since 2003, the Accreditation Council for Graduate Medical~     Education (ACGME) has enforced duty hour regulations limiting shift length, the amount of~     weekly hours worked, and other variables governing shift work. Numerous studies have sought~     to determine the impact of duty hour regulations on the quality of patient care and resident~     education.~      In addition to affecting patient care, medical resident sleep deprivation also has the~     potential to affect residents' well-being and their ability to perform basic tasks. A study~     in surgical residents showed reduced efficiency and safety in performing simulated~     laparoscopy following a period of sleep deprivation that was worse with novices compared to~     experienced residents. Recently, UVA found that resident physicians have greater difficulty~     controlling speed and driving performance with increased reaction times and minor and major~     lapses in attention in the driving simulator following six consecutive night shifts.~      To comply with duty hour restrictions, residency programs have adopted various strategies~     including the creation of night float systems where residents are required to work multiple~     nights in a row. Reduced shift length has been associated with decreased medical errors,~     motor vehicle collisions, and percutaneous injuries.Surgical residents who transitioned to a~     night float system from 24-hour call every 3rd day reported reduced fatigue, more time for~     sleep and independent reading and increased family time, while nurses and patients reported~     improved communication and quality of patient care. In a pilot study of urology residents~     assigned to a 12-hour day shift (Monday-Friday), 12-hour night float (Sunday-Friday) or~     24-hour home call, actigraphy was used to measure total sleep time, sleep latency and depth~     of sleep. Night float did not impact total sleep time or quality of sleep. However, these~     studies did not establish the optimal shift duration~   "
18466|NCT03325231|"~     Radical cystectomy (bladder removal) after bladder cancer necessitates surgical~     reconstruction to allow urine drainage. Usually, this is achieved by either ileal conduit (a~     stoma leads to an external bag) or orthotopic neobladder (the creation of an artificial~     internal bladder). These treatments are most successful when tailored to the patient's own~     lifestyle needs. The current project will explore patient concerns, and the aspects of their~     lifestyles and values, that influence their choice of bladder reconstruction. It will also~     examine which of these concerns and values best predict satisfaction and enhanced QoL,~     following bladder reconstruction. Participants will be recruited from Health Board databases~     of those who have had advanced bladder cancer (grade pT1 and above) and undergone either IC~     or NB procedures within the last five years. 40 participants (equal numbers with each~     surgical procedure) will be randomly selected from the patient databases. They will be~     interviewed by a Researcher and a Clinical Nurse Specialist. A semi-structured interview will~     be conducted to ascertain patients' views about the key factors influencing their treatment~     decision and their satisfaction with the outcome. Approximately 200 participants (equal~     numbers with IC and NB) will be sent three questionnaires to assess their life values, QoL,~     and satisfaction with treatment: (1) Bladder Reconstruction Satisfaction Questionnaire~     measuring levels of satisfaction with bladder reconstruction; (2) EORTC QLQ-C30 measuring QoL~     in areas relevant to cancer patients; and (3) Life Values Inventory measuring values and~     lifestyles important to patients. Participants will be asked to complete the questionnaires~     and return them using a prepaid envelope. Participants will be provided with the contact~     details of a Clinical Nurse Specialist known to them to contact if they require help~     completing the questionnaires.~   "
18467|NCT03325218|"~     Literature shows that less than half of advanced cancer patients accurately understand their~     prognosis, with most being overly optimistic. Investigators suspect that many patients are~     reporting not what they believe, but what they would like to believe. This study aims to~     discern patient's beliefs about prognosis independent of hope, to identify factors that~     influence patient's beliefs, and to explore patient preferences for prognostic information.~      Investigators propose to randomize 200 cancer patients with a prognosis of less than one year~     to receive one of the two versions of a survey. Investigators hypothesize that, although many~     patients will continue to be overly optimistic about their prognosis, those patients~     responding to Version 2, followed by Version 1, will provide more accurate estimates.~      Efforts to improve decision making require an understanding of patients' beliefs and~     preferences for receiving prognostic information and identifying strategies to clearly convey~     that information. This study will fill that gap.~   "
18468|NCT03325205|"~     The purpose of the study is to investigate the effect of High Density- tDCS (HD- tDCS) on~     cognitive function in Alzheimer's Disease. One anode and four return electrodes are placed~     over DLPFC, where low intensity current (2mA) is induced to the surface of the scalp.~     Electrode placement is individualized for each participant. Participants will undergo 15~     stimulations, with a duration of 20 minutes each. All patients will undergo~     neuropsychological assessment and MRI evaluation.~   "
18469|NCT03325192|"~     The primary objective of the study is to evaluate whether the use of a rapid pleurodesis~     protocol using 10% iodopovidone immediately after tunneled pleural catheter placement~     improves time to IPC removal compared to patients who receive an IPC alone.~   "
18470|NCT03325179|"~     Thread-embedding Therapy has been used for treating Obesity in recent years. This research is~     aimed to observe the clinical effect of thread-embedding therapy in treating Simple Obesity.~     One hundred patients is planned to be enrolled in the research and receive a thread-embedding~     therapy. The level of BMI, serum triglyceride, cholesterol and fasting blood glucose will be~     adopted for evaluation before and after therapy.~   "
18471|NCT03325166|"~     This pilot phase II trial study evaluates the usefulness of the ferumoxytol steady state~     magnetic resonance imaging (MRI) technique for response assessment after pembrolizumab and~     radiation therapy in non-small cell lung cancer that has spread to the brain (brain~     metastases). The interactions of monoclonal antibodies such as pembrolizumab, and the body's~     immune system may result in an anti-tumor effect. However, it may also increase inflammation~     around the tumor which cannot be differentiated from true tumor growth on standard MRI. This~     study evaluates ferumoxytol as an MRI contrast agent to differentiate this treatment related~     inflammation from true tumor growth.~   "
18472|NCT03325153|"~     The prevalence of sleep-disordered breathing in Republic of Korea is 27% and 16% in men and~     women aged 40-69 years. Up to 93% of women and 82% of men with obstructive sleep apnea (OSA)~     remain undiagnosed. Polysomnography, the gold standard, is time consuming and costly.~     Patients with undiagnosed OSA may experience obstructive episodes during procedures with~     conscious sedation.~      STOP-Bang questionnaire is the validated questionnaire to screen patients for undiagnosed OSA~     in the preoperative setting. It has high sensitivity (92.9%) for predicting patients with~     moderate to severe OSA.~      Previous studies reported that STOP-Bang questionnaire predicted cardiopulmonary events~     during advanced endoscopic procedures such as endoscopic retrograde cholangiopancreatography~     (ERCP) and endoscopic ultrasound. However, there have been no studies regarding the risk for~     sedation-related cardiopulmonary events in patients with undiagnosed OSA undergoing~     bronchoscopy. Thus, we aimed to evaluate the prevalence of high-risk patients for OSA by a~     screening questionnaire, and to determine whether the questionnaire could predict patients~     who are at risk for cardiopulmonary events during bronchoscopy with conscious sedation.~   "
18507|NCT03324698|"~     Chronic pancreatitis (CP) is a disease characterized by inflammation and their replacement by~     fibrotic tissue. The destruction of pancreatic function and structure are the main~     complications. This retrospective-prospective, multicenter, cohort study was conducted. This~     study aimed to observe the natural history of CP in China, analyse the risk factors for CP~     complications, and establish individual predictions.~   "
18473|NCT03325140|"~     Between 10 and 15% of critically ill patients require platelet transfusion within their~     intensive care unit (ICU).~      Platelets (PLT) are given to prevent bleeding in thrombocytopenic patients or to treat~     bleeding as part of massive transfusion or in bleeding thrombocytopenic patients.~      International and local guidelines (American Association of Blood Banks-AABB) are mainly~     based on experts' opinion. The efficacy of PLT transfusion in the ICU setting remains poorly~     studied and unknown and the administration of PLT may be associated with adverse effects~     including an increased risk of hospital acquired infection. Finally, the short PLT~     shelve-life may be responsible for inventory issues. Altogether, this makes very important to~     improve the evidence that support PLT transfusion in ICU patients.~      This is a multicentre prospective observational study that aims to first determine PLT~     transfusion efficacy and to identify the parameters associated with transfusion efficacy and~     to analyse the compliance with international (and local) guidelines of PLT transfusion in ICU~     patients.~   "
18474|NCT03325127|"~     There are no real-world data that describes how Radium-223 (Ra-223) is being used in~     combination with abiraterone/enzalutamide (abi/enza) or evidence describing outcomes of this~     combination usage for the treatment of metastatic castration resistant prostate cancer~     (mCRPC). To address these data gaps a cohort of mCRPC patients will be chosen who received~     Ra-223 concomitant with abi/enza in first line therapy to assess the treatment patterns~     following first line and clinical outcomes from initiation of first line treatment. For the~     purpose of this study concomitant use will be defined as Ra-223 initiated after at least 6~     months from the start of first line abi/enza. The specific objectives of the study are to~     describe the outcomes, treatment patterns, patient and provider characteristics of mCRPC~     patients treated with Ra-223 concomittantly with abi/enza in first line treatment.~   "
18475|NCT03325114|"~     This open-label study will determine if chlorthalidone is safe and effective for the use of~     reducing urinary calcium excretion over 4 weeks in subjects with type 1 diabetes~   "
18476|NCT03325101|"~     This phase Ib/II trial studies how well dendritic cell therapy after cryosurgery in~     combination with pembrolizumab works in treating patients with stage III-IV melanoma that~     cannot be removed by surgery. Vaccines made from a person's white blood cells mixed with~     tumor proteins may help the body build an effective immune response to kill tumor cells.~     Cryosurgery, also known as cryoablation or cryotherapy, kills tumor cells by freezing them.~     Monoclonal antibodies, such as pembrolizumab, may block tumor growth in different ways by~     targeting certain cells. Giving dendritic cell therapy after cryosurgery in combination with~     pembrolizumab may work better in treating patients with melanoma.~   "
18477|NCT03325088|"~     Asthma is a chronic inflammatory respiratory disease affecting 6 to 7% of the French adult~     population and responsible of 1000 deaths in France every year. Many anti-inflammatory~     treatments are available but few had been developed to target~     hyperresponsiveness.Investigators and searchers of the Institut du thorax have recently~     demonstrated the main involvement of Rac1 monomeric G protein in the contraction of airway~     smooth muscle cells. They show that Rac1 is expressed in the airway smooth muscle cells in~     mice and its activity is increased in the bronchi of asthma induced mice sensitized to~     House-Dust Mite. They further demonstrate that Rac1 inhibition in mice by nebulisation~     reduces airway hyperresponsiveness and pulmonary inflammation. Investigators and searchers of~     the Institut du thorax would like to seek whether targeting Rac1 would be interesting in~     asthmatic patients. Primary objective of this study is to determine if Rac1 expression and~     activity in airway smooth muscle cells are increased in asthmatic patients compare to~     controlled samples (deceased donor samples). Secondary objective is to determine whether~     there is a correlation between Rac1 activity and asthma severity.~      If Rac1 activity in airway smooth muscles is indeed increased in asthmatic patients depending~     on asthma severity, Rac1 could be a potential target to treat airway hyperresponsiveness.~   "
18478|NCT03325075|"~     This clinical study will assess the safety, tolerability, and immunogenicity of VAL-181388 in~     healthy subjects.~   "
18479|NCT03325062|"~     This research study explores the effects of movement pattern training using real-time~     biofeedback insoles after total knee arthroplasty. The purpose of this research study is to~     determine if the addition of a novel movement pattern training program (MOVE) to contemporary~     progressive rehabilitation leads to improved movement quality and physical function compared~     to contemporary progressive rehabilitation (CONTROL) alone.~   "
18480|NCT03325049|"~     Objective: We investigated the outcomes of a nurse-led family intervention, Health Promoting~     Conversations, which focused on family functioning and wellbeing in families with a~     critically ill member.~      Study design: This randomized controlled pilot study used a pre-test, post-test design with~     intervention and control groups to investigate the outcomes of the nurse-led intervention in~     17 families.~      Outcome measures: The Health Promoting Conversations intervention was evaluated using~     validated instruments that measure family functioning and family wellbeing: the General~     Functioning sub-scale from the McMaster Family Assessment Device; the Family Sense of~     Coherence, the Herth Hope Index, and the Medical Outcome Short-Form Health Survey.~     Descriptive and analytical statistical methods were used to analyse the data.~   "
18481|NCT03325036|"~     The purpose of the study is to investigate the clinical usefulness of serum levels of~     immunologic profiles including pro/anti-inflammatory interleukins, other detectable serum~     biomarkers including transforming growth factor b1 (TGFb1) or soluble major~     histocompatibility complex Class I chain-related peptide A (sMICA), and leukocyte~     subpopulations in head and neck cancers patients receiving curative radiotherapy, as~     prognostic biomarkers for disease recurrence and survival.~   "
18505|NCT03324724|"~     Recently, Integrative Cognitive-Affective Therapy (ICAT), a novel intervention for bulimia~     nervosa (BN) and binge eating disorder (BED) that targets emotion regulation deficits, has~     shown promise in reducing eating disorder symptoms as well as improving emotion regulation~     capacities in adults. However, this treatment has not been investigated in an adolescent~     sample. Given the contributing role of emotion regulation in adolescent eating disorder~     symptoms and limited treatment options for adolescents with BN and BED, the aim of this study~     is to adapt the existing adult ICAT treatment for adolescents with clinically significant~     binge eating (ICAT-A) and to evaluate the extent to which ICAT-A is helpful in reducing binge~     eating and associated eating disorder symptoms in a younger sample.~   "
18516|NCT03324581|"~     A trial to assess the safety and efficacy of OPC-64005 in the treatment of Adult~     Attention-deficit/Hyperactivity Disorder~   "
18482|NCT03325023|"~     Polycystic ovary syndrome (PCOS) is the most common endocrinopathy affecting women of~     reproductive age. The pathogenesis of PCOS is not fully understood. The intestinal microbiota~     are believed to be associated with the development of insulin resistance and obesity, and~     therefore contributing to the development of PCOS. Incresed permeability of the intestinal~     mucosal barier and absorbtion of lipoproteinase (LPS) from G (-) bacteria promotes chronic~     inflammation and may lead to insulin resistance.~      Approximately 50-60% of women suffering from PCOS are obese. It is known that lifestyle~     modification and body mass reduction improves endocrine parameters and restores ovulatory~     menstrual cycles in most patients. Currently, the use of probiotics and prebiotics is playing~     an increasingly important role in the treatment of obesity through the modulation of~     intestinal microflora.~      The objectives of the study are based on the following assumptions:~        1. Insulin resistance and compensatory hyperinsulinemia are important aspects in the~          pathogenesis of PCOS and co-morbidity of cardiovascular disease.~        2. Aberrations in the intestinal microflora are associated with the development of obesity~          and insulin resistance.~        3. Dietary modification combined with probiotic supplementation improves endocrine and~          metabolic profiles in women with PCOS.~   "
18483|NCT03325010|"~     This is a Phase 2b, randomized, double-blind, placebo-controlled, dose-optimization study to~     evaluate the efficacy, safety, and tolerability of NBI-98854 titrated to the subject's~     optimal dose administered once daily (qd) for a total of 12 weeks of treatment in pediatric~     subjects with TS.~   "
18484|NCT03324997|"~     The purpose of this study is to assess the safety and efficacy of using Restylane Silk to~     reduce the appearance of photoaging on the chest. Restylane Silk is a temporary hyaluronic~     acid filler currently approved for the lips and fine lines around the mouth. This study will~     compare the appearance of chest wrinkles on half the chest treated with Restylane Silk and~     the other half, which will be treated with placebo.~   "
18485|NCT03324984|"~     The use of 2-Chloroprocaine (PF) spinal anesthesia will reduce the recovery times and~     discharge time of patients undergoing hemorrhoidectomies as compared to 0.75% bupivacaine~     spinal. The primary objective is to compare the recovery times (return of motor and sensory~     function) and discharge time (voiding time) between 2-Chloroprocaine and 0.75% bupivacaine~     spinal anesthesia for hemorrhoidectomies. This is a randomized, prospective study assigning~     patients to either 2-Chloroprocaine (PF) or 0.75% bupivacaine spinal anesthesia group.~   "
18486|NCT03324971|"~     Polypharmacy is an alarming health issue that is defined as prescription of multiple~     medications, of which some are redundant or unnecessary. Due to comorbidities, diabetic~     patients are often prescribed more than 2 medications. Overprescribing occurs either due to,~     prescribing medications that are not indicated, continuation of certain medications beyond~     the time of indication, or prescribing more than one medication with the same effect.~     Improving glycaemic control is the cornerstone for the prevention and treatment of the~     diabetic complications.~   "
18487|NCT03324958|"~     This randomized phase III multicenter trial aims to evaluate the impact of virtual reality~     helmets (visual and audio) during VCB in patients treated for endometrial cancer, in terms of~     pain and anxiety.~   "
18488|NCT03324945|"~     Chemotherapy-induced cognitive impairment (CICI), also known as chemobrain, is a spectrum~     of neurocognitive deficits experienced during and after the administration of chemotherapy~     for cancer. The incidence of CICI is significant, affecting anywhere from 25 to 75% of~     survivors, and the biologic basis is unknown. This novel study is designed to address the~     questions of incidence and biological cause for CICI, while gaining a better understanding of~     the structural and functional effects of chemotherapy on the brain.~   "
18489|NCT03324932|"~     This multicenter, randomized, comparative study will evaluate the efficacy of denosumab to~     prevent the adjuvant therapy of aromatase inhibitors-induced loss of bone mineral density~     (BMD) in breast cancer patients with normal BMD. Investigators will compare the inhibitory~     effects of denosumab on bone loss between participants with normal BMD to whom Letrozole or~     Arimidex will be administered as postoperative endocrine therapy for stage I-IIIA~     postmenopausal hormone-sensitive breast cancer and controls.~   "
18490|NCT03324919|"~     This study is based on a survey about the patient centered care situation and health-related~     quality of life of patients with diagnoses Psoriasis, Urtikaria or Lupus erythematodes.~     Detection of relevant parameters of quality of life by these patients serves for the~     detection of psychosocial burden of the mentioned skin diseases, thus gaining an increasing~     importance for prospective economic issues. This survey is a behaviorally based questionnaire~     for patients with the above diseases and addresses activities such as sleep and rest,~     mobility, recreation, home management, emotional behavior, social interaction, and the like.~   "
18491|NCT03324906|"~     Prader-Willi Syndrome (PWS) is a multisystemic genetic disease characterized by hypotonia,~     mental retardation, hyperphagia, and uncontrollable hunger due to hypothalamic dysfunction,~     caused by dysregulation of genes located in chromosome 15q11-q13. The goal of this study is~     to evaluate the effects of Transcranial Direct Current Stimulation (tDCS) on hyperphagia and~     behavior in PWS. Forty children and adolescents (11-24 years) with clinical and~     cytogenetic-molecular diagnosis of Prader-Willi syndrome will be assessed before and after 10~     tDCS session with: Food Craving Questionnaire (FCQ), Aberrant Behavior Checklist (ABC),~     Dykens hyperphagia questionnaire. Caregivers self-reported the participant's behaviors at~     home and, lately, they will be categorized and quantified. tDCS will be applied for 20~     minutes with electrodes of 25cm2 wrapped in cotton material soaked in saline solution. The~     anode at the left dorsolateral prefrontal cortex (F3) and the cathode at the contralateral~     area (F4). Children from 11-12 years will receive a current of 1mA; above 13 years, 2mA.~   "
18492|NCT03324893|"~     A prospective trial comparing the accuracy of [F-18]-FCH PET/MRI to US and 99mTc-MIBI~     SPECT/CT for pre-operative parathyroid localization in patients with primary~     hyperparathyroidism~   "
18493|NCT03324880|"~     The purpose of this study is to evaluate whether adding an investigational medication called~     recombinant human parathyroid hormone (rhPTH[1-84]) to standard hypoparathyroidism therapy~     (oral calcium and active vitamin D tablets) may result in superior improvements in symptoms~     of hypoparathyroidism assessed by hypoparathyroidism symptom diary (HPT-SD) symptom scale~     compared with standard therapy.~   "
25761|NCT03229733|"~     The aims of this study are to (i) develop exergames by using Kinect system for training UE~     function in patient with stroke; and (ii) to test the game's feasibility and effects in a~     group of patient with chronic stroke.~   "
18494|NCT03324867|"~     Decline in cognitive function after surgery occurs most commonly in older patients and~     patients undergoing major surgeries, such as heart surgery. Postoperative Cognitive~     Dysfunction (POCD) may last a prolonged period of time while Postoperative Delirium (POD) is~     a more acute disturbance in attention, awareness and cognition. The cause of POCD and POD are~     not fully understood, however some of the pathophysiology of POCD is similar to that of~     Alzheimer's disease (AD).~      Insulin given intravenously during heart surgery has been shown to preserve short and~     long-term memory function after the operation. Clinical trials further demonstrated that~     insulin given via the nose (intranasal) improves memory performance of patients with AD or~     cognitive impairment suggests that intranasal insulin also could be a therapeutic option for~     POCD and POD.~      This study is designed to examine the effect intranasal insulin on POCD and POD. The goal is~     to investigate whether administration of intranasal insulin during and after heart surgery~     improves cognitive function postoperatively.~   "
18495|NCT03324854|"~     It´s a pilot study, randomized, realized in the Central Hospital Dr. Ignacio Morones~     Prieto, SLP, Mexico.~      Hypothesis:~      The polyethylene mesh is secure in open ventral repair.~   "
18496|NCT03324841|"~     This repository is a multi-center, outcomes study designed to collect data on the~     demographics, presentation, diagnosis, treatment, cost of associated care, quality of life,~     and outcomes of subjects utilizing Caris Molecular Intelligence® (CMI) Services for the~     treatment of cancer.~   "
18497|NCT03324828|"~     This study evaluate the change in preoperative anxiety, baseline (M1) and pre-induction~     anxiety levels (M3), as shown by children undergoing MAS determined by the m-YPAS scale in~     the different APO management groups.Patients will be allocated in one of this four groups:~     hydroxyzine+clown; hydroxyzine alone, clowns alone or nothing~   "
18498|NCT03324815|"~     The study was prospective, randomized. Patients with cancer pain were evaluated, one group~     receiving methadone with morphine and another group receiving morphine as the only opioid.~     Pain intensity, total morphine dose and adverse effects were evaluated.~   "
18499|NCT03324802|"~     This randomized phase II trial studies how well hypofractionated radiation therapy works in~     preventing the return of tumor cells in breast cancer patients following surgery.~     Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter~     period of time and may kill more tumor cells and have fewer side effects.~   "
18500|NCT03324789|"~     In this study we are going to evaluate patient satisfaction as well as the amount of bone~     loss on using single implant retained partial over-denture versus conventional partial~     denture for treatment of mandibular Kennedy class IV cases~   "
18501|NCT03324776|"~     To examine the effects of adding prandial Afrezza inhaled insulin to patients with type 2~     diabetes who are not controlled after at least 6 months of other diabetes treatments~     including oral agents, basal insulin, or GLP-1 use.~   "
18502|NCT03324763|"~     The diagnostic tests used to detect Helicobacter pylori (H. pylori) infection are either~     direct and invasive, as in culture, histology and the rapid urease test (RUT) or noninvasive,~     such as serology, the 13C-Urea breathe test or the stool antigen test. However, there is no~     single reference method to detect the H. pylori infection reliably and accurately. The~     specificity of gastric biopsy cultures is 100%, but the sensitivity is lower. Histology and~     RUT provide excellent diagnostic accuracy, but the detection of H. pylori is decreased in~     cases of bleeding peptic ulcers or gastric atrophy. Therefore, it is recommended that at~     least two tests should agree when defining the H. pylori infection in children. Quantitative~     real-time polymerase chain reaction (qPCR)-based methods have been shown to be the most~     reliable for H. pylori detection in adults and in children. In children, the reference method~     for H. pylori infection detection is invasive, namely upper digestive endoscopy with gastric~     biopsy for histology, culture, RUT and qPCR. A noninvasive alternative to detect H. pylori~     antigen in stools could use a quick one-step immuno-chromatographic technique.~      The aim of this study was to assess the performance of a new quick, noninvasive, one-step~     immuno-chromatographic, stool antigen test (ALERE Inc, Jouy-en-Josas, France) for the~     detection of H. pylori infection in children.~   "
18503|NCT03324750|"~     Introduction: Nearly 1% of the population is currently treated with long-term corticosteroid~     therapy. When corticosteroids are introduced, patient information concerning the adverse~     effects and the modalities of prevention by the lifestyle changes is usually proposed.~     However, studies have shown an imperfect acquisition of this information about treatment and~     prevention of adverse effects, as well as a difficult implementation on diet and physical~     activity advices. In this study, we aimed to evaluate the difficulties encountered by~     patients with dietary advice in the context of long-term corticosteroids use in order to~     optimize care, drug adherence and the quality of life of patients.~      Methods: We will recruite adult patients from general medicine and rheumatology practice and~     treated by long-term corticosteroids (≥ 3 months, ≥ 5mg/day). We will perform a qualitative~     analysis in a semi-directed interview.~   "
18504|NCT03324737|"~     Gestational diabetes (GDM) complicates about 20% of pregnancies in Singapore. These women are~     at high risk of developing type 2 diabetes years after pregnancy; seven times more likely~     than normal. Achieving a healthy weight post-delivery is key to reduce the risk of future~     diabetes. This study, from a multidisciplinary team, intends to create a unique seamless care~     model to restore optimal weight post-delivery in women with recent GDM. The innovation~     examined in this randomized control trial is an INTERACTIVE SMARTPHONE APP. The APP monitors~     weight, dietary habits, and exercise activity patterns, gives feedback, and provides~     practical personalized lifestyle coaching that is culturally appropriate and customized to~     the Singapore context. If efficacy is confirmed in this RCT, the APP can be easily scaled up~     as a cost-effective way to potentially prevent or delay the onset of type 2 diabetes in~     Singaporean women. Additionally, measurement of markers of cardiometabolic risk will give~     indications on future cardiovascular health, utilizing an underused opportunity to improve~     women's health.~   "
18506|NCT03324711|"~     The main objective of the study is to analyze the psychometric properties of the~     antillanisée version of the Mini Mental State Examination (MMSEa).~      The methodology used will permit to explore the feasibility, acceptability, validity and~     reliability of the tool.~      The psychometric validation of a version adapted transculturally will increase the value of~     the results obtained with this test and will make it possible to refine the screening of~     existing cognitive disorders for elderly subjects with Alzheiner's disease or related~     disorders.~   "
18508|NCT03324685|"~     The primary objective of this study is to evaluate the effect of multiple doses of a uridine~     diphosphate glucuronosyltransferases (UGT)-inducing oral contraceptive (OC) regimen (ethinyl~     estradiol and levonorgestrel) on the PK of BIIB074 at steady state; evaluate the effect of~     multiple doses of BIIB074 on the pharmacokinetics(PK) of an OC regimen (ethinyl estradiol and~     levonorgestrel) at steady state.~      The secondary objective of this study is to evaluate the safety and tolerability of BIIB074~     when administered alone and when coadministered with a UGT-inducing OC regimen containing~     ethinyl estradiol and levonorgestrel and to evaluate the effect of a UGT-inducing OC regimen~     (ethinyl estradiol and levonorgestrel) on the PK of the M13, M14, and M16 metabolites of~     BIIB074.~   "
18509|NCT03324672|"~     Pregnant women often suffer from lumbar pain , specially during the last semester . Usually~     physiotherapy and manual therapy on TRIGGER point help them .~      But there is also another type of support , the Kinesio-Taping using the pose of a strip~     which aims to mobilize the muscle without any restriction.~      The purpose is to reduce the pain with the combo therapy (TRIGGER point plus Kinesi Taping)~   "
18510|NCT03324659|"~     This study evaluates the analgesic effect of a combination treatment of exercise and~     mindfulness based meditation in patients with chronic back pain. Half of the participants~     will partake in a 4-week exercise and meditation intervention, while the other half will~     receive a placebo treatment. The investigators hypothesize that a combination treatment~     reduces pain more than the control intervention.~   "
18511|NCT03324646|"~     Background:~      A radioligand is a radioactive substance that is used to diagnose diseases. A new ligand is~     called [11C]PS13. This has a small amount of radioactivity that can be detected by a positron~     emission tomography (PET) scan. If this ligand works well in this study, researchers may be~     able to use it to better understand and diagnose brain disorders.~      Objectives:~      To evaluate if [11C]PS13 can measure its receptor, which is involved in inflammation. To see~     if researchers get the same results when scanning a person twice.~      Eligibility:~      Healthy people ages 18 and older who are in Protocol 01-M-0254.~      Design:~      This study requires three visits of 2 5 hours each.~      Participants will have 2 PET scans with [11C]PS13.~      A needle will guide a small plastic tube (catheter) into an arm vein. The needle will be~     removed, leaving only the catheter in the vein. The ligand will be injected through the~     catheter.~      The PET scanner is shaped like a doughnut. Participants will lie on a bed that slides in and~     out of the scanner.~      Participants will wear a molded a plastic mask that fits the head.~      Another catheter will be put into an artery at the wrist or elbow area.~      Vital signs will be monitored during the PET scan. Participants will have a test during the~     PET scan to monitor heart function.~      Participants will have blood and urine tests.~      Participants will have 1 magnetic resonance imaging (MRI) scan. The MRI scanner is a metal~     cylinder surrounded by a strong magnetic field. Participants will lie on a table that slides~     in and out of the cylinder.~   "
18512|NCT03324633|"~     The ANRS CO13 HEPAVIH cohort is a prospective and multicentric cohort created in 2005 with~     the originality to cover two therapeutic domains of key importance, AIDS and hepatitis C. The~     cohort, is unique in Europe with more than 1800 participants followed over 10 years including~     quality of life and compliance to treatment data.~   "
18513|NCT03324620|"~     The objective of the study is to evaluate the benefits and costs of a comprehensive~     rehabilitation program (physical, psychological, social and educational) for patients~     receiving hematopoietic stem cell transplantation (HSCT). It is a prospective longitudinal~     study with a control group. Patients will be included who will perform a transplant in the~     hospital environment. The variables of the study will be: number and type of complications,~     days of hospitalization, readmissions, economic cost of the program, exercise tolerance,~     assessment of muscular atrophy, health related quality of life, knowledge and self-management~     of the disease, all of them adjusted for the variables age, sex and hematological disease, as~     well as comorbidities. The evaluations will be performed before transplantation (between one~     and three months before), during the conditioning phase (intensive chemotherapy), before~     discharge, after immediate discharge and after discharge up to one year. The nursing team~     will perform the patient's therapeutic education, stimulation for physical activity, as well~     as evaluation and follow-up measures. Early detection of the needs of the rest of the~     rehabilitation team will be carried out. There will be a support function for the~     physiotherapist in regard to physical activity. In Spain there is no interdisciplinary team~     that provides comprehensive care and rehabilitation to this type of patients and few studies~     are dedicated to rehabilitation beyond physiotherapy as a preventive tool for future~     disabilities.~   "
18514|NCT03324607|"~     The purpose of this study is to determine whether the new inhaler, Bevespi improves lung~     function. Magnetic resonance imaging (MRI) using inhaled hyperpolarized 129Xe gas, that can~     provide useful images of the functioning of the lung will be used as a new measure to~     determine change in function. The investigator anticipate these images will provide more~     specific information about lung disease than standard lung function tests in response to~     treatment.~   "
18515|NCT03324594|"~     Over the decades, male condoms had been widely commercialized and used to protect against~     unintended pregnancy and sexually transmitted infections (STI). While natural rubber latex~     (NRL) male condoms has majority proportion of male condoms in the market, synthetic male~     condoms (SMC) made from polyurethane or other synthetic materials remain new to the~     consumers. Notably, synthetic male condoms are found to be more durable, non-allergenic and~     have better compatibility with lubricants when compared to NRL male condoms. The SMCs that~     have FDA approval and commercially available are AvantiTM (polyisoprene condom), Trojan~     SupraTM (polyurethane condom) and eZ.onTM (polyurethane condom). Although the effectiveness~     of SMCs in the prevention of sexually transmitted infections has yet to be established, SMCs~     are believed to be comparable to NRL male condoms in both STI prevention and contraception~     protection. Notwithstanding, a recent literature had reported the shortfall on the quality of~     variant male condoms in the market, especially nonconforming volumetric capacity, burst~     pressure and freedom from holes. This warrant the current investigation, to evaluate the~     functional performances of two newly invented synthetic male condoms, branded as~     WONDALEAF-CAP (WLC) and WONDALEAF-ON-MAN (WLM). Apart from being made of polyurethane,~     the major feature of WLC and WLM are nonetheless their adhesive coating on the outer rim of~     the condom opening which by securely adhering to the foreskin, prevent slippage of condom and~     spillage of male ejaculate or secretions when the penis is flaccid, and thereby improve the~     user-friendliness of condom usage.~   "
18517|NCT03324568|"~     This study will evaluate the impact of different types of educational materials on parent and~     child feeding behaviors. Specifically, the investigators will test the feasibility,~     acceptability, and effectiveness of an investigator-developed series of parent training~     videos designed to teach behavioral strategies to promote feeding in young children with~     feeding difficulties.~   "
18518|NCT03324555|"~     ORIC-GR-17001 is an open-label, single center, non-randomized, single ascending dose study in~     healthy male subjects and healthy female subjects of non-child bearing potential. In this~     study, ORIC-101 will be administered as single-ascending oral doses. The primary objective is~     to characterize the safety and tolerability of oral ORIC-101.~   "
18519|NCT03324542|"~     Purpose To report the long-term efficacy of patients with neovascular age-related macular~     degeneration (nAMD) treated with anti-vascular endothelial growth factor (VEGF) in Changhua~     Christian Hospital in Taiwan.~      Method Retrospective case series of patients with nAMD that were treated with intravitreal~     injection of anti-VEGF and had a minimum follow up of 48 months. Every patient was initially~     treated with 3 loading doses of either bevacizumab or ranibizumab, followed by a loose treat~     and extend regimen. Eyes were divided into 2 groups according to whether aflibercept was~     later used as a rescue therapy (group 2) or not (group 1). Patients underwent best-corrected~     visual acuity (BCVA) testing, optical coherence tomography, and ophthalmic examination at~     baseline and all the scheduled follow-up visits.~   "
18520|NCT03324529|"~     This is a minimal risk case-controlled single arm intervention study, including 10 patients~     with a prior history of takotsubo and 10-age and sex matched healthy controls. Subjects will~     undergo in laboratory testing to measure autonomic function. They will then undergo a 15-week~     program of device-guided breathing with remote measures of autonomic function obtained at~     home. Analysis will determine the reproducibility of home autonomic measures and the provide~     preliminary data to determine the efficacy of device-guided breathing on autonomic measures~     and quality of life in patients with takotsubo.~   "
18521|NCT03324516|"~     The primary objective is to identify which patients undergoing a traditional pterional~     approach with 2 different surgical techniques for TMS (Temporal Muscle Suspension) will~     develop TH (Temporal Hollowing. Pre and post-operative CT scans will be reviewed and analysis~     with previously proven metrics will be performed.~   "
18522|NCT03324503|"~     This is a multicenter, single-arm, unblinded/open-label study of the effect size of HRCT~     endpoints in response to glucocorticoid induction therapy in subjects with a diagnosis of~     pulmonary sarcoidosis who have not received glucocorticoid as initial sarcoidosis therapy (≥~     20 mg/day prednisone or prednisolone) or other sarcoidosis therapy for at least 3 months~     prior to enrollment. This study will enroll a total of approximately 24 subjects.~   "
18523|NCT03324490|"~     Patients with respiratory disease have an increased risk of developing complications~     perioperatively. The use of regional anesthesia decreases this risk with better postoperative~     outcome. The aim of this study is to compare the safety and efficacy of thoracic spinal~     versus thoracic epidural anesthesia for open nephrectomy in patients with~     obstructive/restrictive lung disease.~   "
18524|NCT03324477|"~     This study is designed to investigate the relevance of the timing of hypertonic saline~     administration either as a preload or as a coload on hemodynamic parameters in patients~     undergoing TURP surgeries.~   "
18525|NCT03324464|"~     The goal of the current project is to assess the efficacy of Central Executive Training (CET)~     for youth with ADHD. CET is a new, computerized training intervention that targets specific~     components of the working memory system. Two versions of CET were developed as part of our~     R34, each targeting a different combinations of executive functions. The final CET protocol~     reflects the contributions and feedback of a diverse group of caregivers, children with ADHD,~     and recognized experts in human cognition, ADHD treatment research, randomized control trial~     (RCT) intervention design methods, serious game theory and task design, cognitive training,~     and the role of executive dysfunction in ADHD.~   "
18526|NCT03324451|"~     The aim of the study is to assess the effectiveness of an intervention for insulin injection~     initiation based on the Transtheoretical Model (TTM) for insulin-naïve patients with type 2~     diabetes mellitus (T2DM).~   "
18527|NCT03324438|"~     This study addresses the critical need for improving Type 1 Diabetes (T1D) health outcomes in~     high-risk youth (A1C=9-12%; ages 10-17 yrs) (AIC: glycated hemoglobin) where suboptimal~     glycemic control has severe acute and long-term complications with potentially life~     threatening consequences. Lack of regular contact with T1D care providers, continued T1D~     nonadherence, and suboptimal behavioral and mental health functioning compromises the~     physical health of youth with T1D and the ability of T1D teams to provide effective~     treatment. If the aims of this study are achieved, this study will change T1D care practices~     by providing high-risk youth with T1D, and their parents, medical and behavioral health~     support via home telehealth intervention. This has the potential to significantly change~     access to T1D care, decrease time spent in hyperglycemia, reduce the frequency of hospital~     admissions, and improve glycemic control. In addition, this study's use of Multiphase~     Optimization Strategy (MOST), a highly efficient experimental strategy to determine effective~     intervention components, should be generalizable to all individuals with T1D, leading to~     cost-effective, home telehealth intervention programs. Innovative aspects include: 1)~     assessment of physical and behavioral health characteristics associated with high-risk~     status; 2) delivery of home telehealth that incorporates: 2a) medical and behavioral health~     care delivered with the endocrinologist and behavioral health specialist working together~     with high-risk youth; 2b) personalized intervention to improve T1D adherence and T1D clinical~     health outcomes; 2c) personalized intervention to improve mental health comorbidities and T1D~     clinical health outcomes; and 3) an underused methodological approach for optimizing~     intervention components to be delivered at point of care.~   "
18528|NCT03324425|"~     This study recruits patients with metastatic breast cancer who have progressed on their~     current regimen of dual anti-HER2 therapy. This study evaluates whether or not the addition~     of simvastatin to the dual anti-HER2 therapy regimen helps make the tumor respond to the~     anti-HER2 therapy again. All participants will receive simvastatin in combination with their~     current anti-HER2 therapy regimen.~   "
20725|NCT03295721|"~     This is a Phase 3, randomized, double-blind, saline placebo- and active-controlled,~     multicenter study to evaluate the analgesic efficacy and safety of HTX 011 administered via~     local administration into the surgical site in subjects undergoing bunionectomy.~   "
18529|NCT03324412|"~     Rheumatoid Arthritis (RA) is an autoimmune disease that results in a chronic inflammatory~     disorder that may affect many synovial joints, and may cause serious disability. It has been~     confirmed that Tripterygium Wilfordii has effects of anti-inflammatory, immunosuppressive and~     cartilage protection. This is a multicenter ,double Blind, randomized study to evaluated the~     efficacy and safety of Tripterygium Wilfordii in treating of patients with rheumatoid~     arthritis (RA) and establish a prediction model for Tripterygium Wilfordii response of~     rheumatoid arthritis (RA).~   "
18530|NCT03324399|"~     ALS, also known as Lou Gehrig's disease, is a neurodegenerative disease which is fatal.~     Treatment for ALS is limited and currently consists of primary symptom relief or support. In~     addition, time from diagnosis to death averages 3-5 years. New Biotic, LLC has submitted an~     Orphan Drug Designation Application for an investigational probiotic and have indicated the~     need for more study of this orphaned drug in ALS patients.~   "
18531|NCT03324386|"~     Few studies show the benefits of educational technologies a support for the control of~     chronic diseases. The approach known as 'embracement' adopts relational strategies or soft~     technologies which promote bonding and may impact therapy adherence and quality of life in~     hypertensive patients.Objectives:To assess the impact of the embracement approach on therapy~     adherence, quality of life, and the white coat effect in hypertensive outpatients followed in~     a specialized clinic. This approach may be associated or not with the use of educational~     technology in a virtual learning environment(VLE) for distance learning (DL) and with use the~     educational technology in Blended E-learning (E-BLENDED)~   "
18532|NCT03324373|"~     The purpose of this research study is to see what effect the combination of lenvatinib plus~     everolimus has on the tumors in patients with locally advanced and metastatic renal cell~     carcinoma, prior to cytoreductive nephrectomy.~   "
18533|NCT03324360|"~     Upwards of 40% of cancer patients will develop brain metastases during their illness, most of~     which become symptomatic. The burden of brain metastases impacts the quality and length of~     survival. Thus the management of brain metastases is a significant health care problem.~     Standard treatment options include stereotactic radiosurgery and/or whole brain radiation.~     There is a great interest in studying the association between the functional characteristics~     of tumors - such as tumour hypoxia and lactate accumulation - and clinical outcomes in order~     to guide management. These characteristics may predict future tumor behavior and stratify~     risk of therapy failure. Hyperpolarized 13C MR imaging is a novel functional imaging~     technique that uses 13C-labeled molecules, such as pyruvate, and MRS to image in vivo tissue~     metabolism.~      There is significant clinical heterogeneity in patients with brain metastasis due to~     differences in underlying tumour biology. Biochemical differences in tumour metabolism have~     been shown to correlate with response to therapy. While the significance of tissue hypoxia~     for radiosensitivity has been established for years, the impact of lactate accumulation on~     radiosensitivity has only recently been recognized. Studies have shown that tissue lactate~     levels correlate with radioresistance in several human tumours. Hyperpolarized 13C pyruvate~     MRS has been shown in numerous pre-clinical studies and a recent clinical study to have great~     potential as a metabolic imaging tool. Our study seeks to establish the role of~     hyperpolarized 13C MRS in characterizing the metabolic features of intracranial metastasis.~     The results of this study will provide insight into intracranial metastatic disease~     signatures with MR spectroscopy and determine if there is added benefit for incorporation of~     this new technique into future clinical MRI protocols. If the technique can accurately~     differentiate between aggressive and indolent tumours based on MR spectroscopic patterns,~     hyperpolarized 13C MRS may have wide-ranging utility in the future. In the era of~     personalized medicine, the ability of imaging tests to predict response to therapy would open~     the door for individualized treatment options specific to each patient's disease biology.~   "
18534|NCT03324347|"~     Dog-assisted therapy (DAT) is used in several contexts within various areas of health care.~     One documented effect is that the proximity of a dog may lower anxiety in perceived stressful~     situations. Many individuals are afraid to visit the dentist, and someone to the extent that~     they need medication or anesthesia in order to complete their dental treatment. Based on the~     literature and own empirical observations, the investigators believe that dog-assisted~     therapy in connection with dental care may have a positive effect on children with dental~     anxiety or children that avoid dental care. It is desirable to restrict the use of drugs for~     these patients because of associated risk and side effects.~      The purpose of this pilot study is to evaluate whether using a specially trained therapy dog~     can have a positive effect on children who are afraid in a dental care setting. Eligible~     participants (n=16) will meet twice at the dental clinic; one treatment session with a~     therapy dog in the dental clinic and one without. The therapy dog will be accompanied by a~     certified dog handler. The investigators will measure physiological variations before, during~     and after the treatment session. The guardian will complete validated questionnaires~     portraying the participant's experience of previous dental care. The participant and their~     guardian will also complete validated questionnaires describing their reactions from the two~     treatment sessions. A descriptive log for each session will be completed by the~     investigators.~   "
18535|NCT03324334|"~     Graves disease in ulcerative colitis:~      The connection between Graves disease and Inflammatory bowel disease is well known in the~     literature, but thyroid disorders have not been considered extra-intestinal manifestations of~     ulcerative colitis. In most cases, the diagnosis of thyroid disease has preceded that of~     Inflammatory bowel disease. Early studies have suggested a relationship between thyroid~     abnormalities and ulcerative colitis . But it is still uncertain whether the coexistence of~     Grave's and ulcerative colitis diseases is due to a specific reason or a coincidence.~   "
18536|NCT03324321|"~     In the UK, 23,000 (15%) of the 150,000 people who suffer a stroke each year have bleeding in~     the brain, also referred to as acute intracerebral haemorrhage (ICH). An Autoregulation Index~     (ARI) can be assigned between 0 and 9 (0 being poor and 9 being the most efficient CA~     observed) to gauge how good the control over blood flow is at a given time. Dynamic CA (dCA)~     is a measure of the response of cerebral blood flow (CBF) to rapid changes in blood pressure~     (BP), and several key studies have shown impaired dCA post-acute ICH. The most recent study~     demonstrated that dCA impairment lasts up to 12 days. This is particularly important to~     understand, since our preliminary work has recently shown that changes in carbon dioxide~     using simple breathing exercises can improve Autoregulation.~      Unfortunately, there are limited non-pharmacological management options and significant~     opportunities to improve patient outcome in ICH. The proposed study addresses this area, by~     investigating whether a simple breathing exercise in survivors of ICH is safe, feasible and~     effective in reducing brain injury by improving cerebral autoregulation.~   "
18537|NCT03324308|"~     Coronary artery computed tomographic angiography (CTA) is a widely used, highly accurate~     technique for the detection of coronary artery disease (CAD), with sensitivity and negative~     predictive values of over 90% (1-4). Patients with normal CTA findings have an excellent~     prognosis and do not require further testing for CAD (5). However, like invasive coronary~     angiography (QCA), CTA is an anatomic test and, unless lesions are very severe (>90%~     stenosis), cannot reliably predict the impairment of flow (functional significance) of~     intermediate grade stenoses.~      For this reason, in approximately 15-25% of patients, additional functional testing may be~     required after CTA, usually in the form of stress testing (6-8). Stress testing is commonly~     done by exercise or pharmacologic stress with electrocardiographic monitoring and often,~     imaging of myocardial perfusion by nuclear scintigraphy (MPI) or detection of abnormal~     contraction by echocardiography. This requires a separate procedure, entailing time, expense~     and limited risk. Furthermore, in patients with previously known CAD, CTA alone is not an~     adequate test, because in most cases there are multiple lesions that are possible sources of~     ischemia.~      Over the last 10 years, these investigators and others around the world have developed a~     method of imaging myocardial perfusion by CT (CTP). This test is an adjunct to the usual~     Cardiac Computed Tomography Angiography (CCTA) procedure and can be done immediately~     thereafter, using conventional pharmacologic stress agents. It has demonstrated accuracy in~     many single center trials, and in this large multicenter study, the CORE320 trial (9,10)~     which showed a high accuracy in predicting the combined results of QCA plus MPI testing and a~     second multicenter trial established non-inferiority of myocardial CTP compared with nuclear~     stress testing (11,12). Additionally, this investigator group has published a direct~     comparison of diagnostic performance of myocardial CTP imaging and SPECT myocardial perfusion~     imaging and demonstrated superior diagnostic performance of CTP imaging compared with SPECT~     for the diagnosis of significant disease on invasive angiography (13).~      CTP images can be acquired with two different approaches: static or dynamic. In the CORE320~     study, the CTP protocol used static acquisition method. The static CTP method, samples a~     snapshot of the iodine distribution in the blood pool and the myocardium over a short period~     of time, targeting either the upslope or the peak of contrast bolus. The notion behind this~     is that, at the upslope of the contrast, the difference in attenuation value of the ischemic~     and remote myocardium is at the maximum which enables for qualitative and semi-quantitative~     assessment of myocardial perfusion defects. The static CTP, however, does not allow for~     direct quantification of the myocardial blood flow (MBF). One of the drawbacks of static CTP~     lies in the acquirement of only one sample of data and the possibility of mistiming of the~     contrast bolus that results in poor contrast-to-tissue ratios by missing the peak attenuation~     (14). Output and flow rate of the contrast material may affect bolus timing. In addition, the~     acquisition of data from sequential heartbeats affects the attenuation gradient and may~     result in a heterogeneous iodine distribution, mimicking perfusion defects (15). Furthermore,~     the static CTP is limited in detection of balanced ischemia, where the perfusion of the~     entire myocardium is impaired and therefore there is no reference remote myocardium for~     comparison for semi-quantitative or qualitative static methods of CTP interpretation.~      Dynamic CT perfusion imaging uses serial imaging over time to record the kinetics of~     iodinated contrast in the arterial blood pool and myocardium. This technique allows for~     multiple sampling of the myocardium and the blood pool and creating time attenuation curves~     (TAC) by measuring the change in CT attenuation over time. Mathematical modelling of TACs~     permits for direct quantification of MBF. Despite its advantages, the use of dynamic CTP were~     limited in the past. A high temporal resolution and high number of detectors are required for~     dynamic CTP to allow for entire myocardial coverage, and in order to obtain multiple~     consecutive images at high heart rates(16,17). But the main challenge of dynamic CTP~     acquisition was the high radiation dose associated with this technique. Nevertheless, with~     the introduction of the cutting-edge 320 detector CT scanning systems with fast gantry~     rotation the issue of the cardiac coverage is eliminated(17). The second-generation 320-row~     scanners also permit the quantification of the MBF with dynamic CTP acquisition with~     relatively low-dose of radiation(18,19).~      In this study the investigators aim to evaluate the feasibility, safety and accuracy of the~     low-radiation dose dynamic myocardial CT perfusion compared to static CTP approach to detect~     hemodynamically significant coronary artery disease.~   "
18538|NCT03324295|"~     cataracts could be cured with eye drops. Some studies reported that in chronic renal failure,~     the occurrence of cataract is rare and the mechanism is unknown. The aim of this research is~     to describe correlation between urea concentration in the serum and aqueous humor and~     development of age related cataract.~   "
18539|NCT03324282|"~     This study will assess efficacy (based on response rate) and safety (based on grade ≥ 3~     severe adverse effects) of the combination Gemcitabine Cisplatin (GC) + anti-PD-L1 (avelumab)~     in first-line treatment for locally advanced or metastatic urothelial bladder cancer~     patients, after 6 cycles of treatment (or at 18 weeks if less than 6 cycles have been given,~     or earlier if a second line treatment is needed, before this new anticancer treatment has~     been started).~   "
18540|NCT03324269|"~     The evaluation of pain, a conscious response, in the anesthetized patient remains one of the~     main challenges in anaesthesia.~      Opioids remain the cornerstone for perioperative analgesia, albeit frequently associated with~     side effects. Most of these side-effects are dose-dependent.~      Thus intra-operative monitors are necessary to measure the balance between Nociception and~     Anti-Nociception (NAN balance) by an adequate opioid administration.~      Recently the NOL monitor was released.The NoL index ranges from 0 to 100 and is based on a~     nonlinear combination of nociception-related physiologic variables, specifically heart rate~     (HR), heart rate variability at the 0.15- to 0.4-Hz band power, photoplethysmograph wave~     amplitude (PPGA), skin conductance level, number of skin conductance fluctuations, and their~     time derivatives. The NoL index estimates the nociceptive/antinociceptive state from these~     component measures using random forest regression.~      NOL index has been studied in many types of surgery apart from cardiac surgery. Cardiac~     surgery has one of the frailest patient populations, in whom hemodynamic stability is of~     utter importance.~      In our institution, a combination of TCI propofol (Schnider model) and remifentanil (Minto~     model) is used to for most of the anaesthetic procedures, including cardiac anaesthesia.~     Remifentanil is titrated to prevent an increase in blood pressure and hearth rhythm at~     noxious stimuli, such as surgical incision, sternotomy and adapted following hemodynamic~     trend during surgery.~      The hypothesis of this study is to develop a calibration test using the NOL index variation~     to define the individual most appropriate NAN balance using remifentanil TCI before the start~     of surgery and before a very strong noxious surgical stimulus such as surgical incision in~     thyroid surgery and sternotomy during cardiac surgery.~      Before the start of surgery, the investigators want to titrate in each patient the~     remifentanil Ce required to abolish the NOL index response to a calibrated noxious tetanic~     stimulus (Tetanus 60 mamp, 100 Hz, 30 seconds). Thus this individual remifentanil Ce will be~     the remifentanil level programmed before surgical incision and sternotomy. NOL and~     hemodynamic responses will be recorded during the entire duration of thyroid surgery and~     until the cardiopulmonary bypass during cardiac surgery.~      The individual relation between the remifentanil calibration level and the patient's response~     will be studied.~   "
18541|NCT03324256|"~     The purpose of this study will be to examine the acute effect of commercially available~     energy products on endothelial function, arterial stiffness and thrombosis in healthy young~     males.~   "
18542|NCT03324243|"~     This is a phase II, multicenter, single-arm study to assess the safety and feasibility of~     combining crenolanib with fludarabine and cytarabine chemotherapy in pediatric patients with~     relapsed/refractory FLT3-mutated AML. Patients will receive up to two courses of salvage~     chemotherapy with fludarabine, cytarabine, and crenolanib. Response will be assessed between~     day 29-43 of each course.~   "
18543|NCT03324230|"~     This is a multicentre, observational study focusing on exacerbation events in patients with~     severe eosinophilic asthma on Mepolizumab.~      Mepolizumab is an anti-IL5 (Interleukin 5) monoclonal antibody which blocks the eosinophilic~     activation pathways associated with decreasing asthma control. The pre-licensing studies have~     shown that Mepolizumab decreases asthma exacerbation events by approximately 50%, this study~     seeks to understand the underlying mechanisms of the remaining 50% of exacerbations.~      The study will enrol patients within GINA classification 4 and 5 who are known to difficult~     asthma services across four UK sites. Some patients will recently have been commenced on~     Mepolizumab, whilst others will be commenced on the drug on entry to the study. The patients~     will have baseline measurements of biomarkers, lung function, sputum analysis and quality of~     life questionnaires on study entry, after which patients will be asked to contact the clinic~     at the first signs of worsening asthma symptoms to arrange a clinic visit prior to commencing~     rescue treatment. They will be clinically assessed with review of peak flow and symptom~     diaries, measurements taken at baseline will be repeated and a decision on the nature of the~     exacerbation and treatment required will be made.~      This is an observational study, all outcomes will be exploratory.~   "
18544|NCT03324217|"~     Motor imagery is defined as a dynamic mental process of an action, without its real motor~     execution. Action observation training consists of watching an action performed by someone~     else. The primary objective of this study was to evaluate the effects of motor imagery and~     action observation combined with a hand grip strength program on strength gains in~     asymptomatic participants. The secondary objective was to assess the influence of motor~     imagery and action observation training combined with a hand grip strength program on~     electromyographic activity and intramuscular oxygenation of the forearm muscles.~   "
18545|NCT03324204|"~     The aim of the trial is to compare the efficacy of extracorporeal shock wave therapy (ESWT)~     versus neuromuscular training (TR) in reducing pain in women with patellofemoral pain (PFP).~     Women with PFP will be randomly divided into two therapeutic groups: ESWT and TR. The ESWT~     group will undergo extracorporeal shock wave therapy to the iliotibial band and tensor fascia~     latae. The TR group will be treated with neuromuscular training. The women's gait will be~     analysed and the strength of hip abductors and internal rotators will be measured.~     Additionally, the women's pain and health status will be assessed with the visual analogue~     scale and the Lysholm Scale. Outcomes will be registered at baseline, and then at five weeks~     and at three months post-therapy~   "
18546|NCT03324191|"~     There are numerous factors known to determine the relative rate of lipid metabolism at rest~     between and within individuals, including: biological sex, endogenous carbohydrate~     availability, training status and, in particular, feeding. Recent focus has been placed on~     the potential of alternative nutrients, nutritional supplements and pharmacological agents to~     modify substrate selection in favour of greater lipid oxidation (e.g. caffeine, carnitine,~     green tea) and/or to alter lipid absorption (e.g. caffeine, carnitine, orlistat, green tea~     preparations).~      Polyphenol-rich tea extract can have effects on lipase activity in the pancreas causing~     reduced fat absorption. The present study is to assess the potential for tea extract alone to~     be as effective at the liquid product in a western population.~   "
18555|NCT03324074|"~     Pylorus is a tubular structure which contains circular muscle, forming pyloric sphincter~     which separates stomach and duodenum. The motor activity of the pyloric sphincter is less~     investigated. Antroduodenal manometry is an invasive and time consuming technique also~     limited by inability to measure compliance of the sphincter.~      Recently, a new technique functional lumen imaging probe (FLIP) which is based on principle~     of impedance planimetry (IP). The endoluminal FLIP (EndoFLIP) EF -100 system uses a~     multi-detector IP system to produce a 3-dimensional outline of a sphincter. EndoFLIP can~     measure tissue distensibility and geometric changes through volumetric distention with~     real-time images. The esophagogastric junction (EGJ) has been well studied using EndoFLIP,~     studies for assessment of pyloric function are lacking.~   "
20726|NCT03295708|"~     In this proposed study, the investigators will evaluate the effects of fish oil add-on in~     treatment of major depressive disorder(MDD).~   "
18547|NCT03324178|"~     Difficulty to sustain attention over a prolonged period of time is one of the core~     difficulties experienced by people who have undergone traumatic brain injury. Rehabilitation~     of attention is often based on compensatory strategies, because of the limited impact of~     cognitive training on improving attentional capacity after brain injury. New therapeutic~     approaches to explore the plastic recovery of the brain after injury, and consequent~     performance improvement, are warranted.~      Neurofeedback (NFB) allows the self-regulation of brain activity using visual feedback. Very~     recently, it has been demonstrated that NFB training targeted at reducing alpha power (alpha~     desynchronization NFB), can induce initial plastic changes in brain networks associated with~     attention. It has been proposed that NFB can improve cognitive performance by tuning~     oscillatory activity of the brain towards a more healthy balance between neural network~     flexibility and stability. It is speculated that the use of alpha desynchronization NFB~     training, with people who present with brain injury, can enhance sustained attention in as~     much as the training promotes neural variability during resting state (i.e. more flexible~     network configuration) and neural stability during a sustained attention task (i.e. more~     stable network configuration).~      However, before assessing the effectiveness of the intervention, it is necessary to evaluate~     the feasibility and acceptability thereof. This study will recruit 14 participants and~     randomly assign them to two groups: a NFB group and a video games control group. Long-term~     changes will be evaluated at two time points for both groups: baseline and post-intervention.~     The NFB group will have a follow-up session one week after the intervention, to evaluate~     whether there are long lasting changes after NFB training. In addition, short-term changes of~     NFB will be evaluated for the experimental group, contrasting EEG activity immediately before~     and after the last NFB session.~   "
18548|NCT03324165|"~     Acute appendicitis is one of the most common causes of acute abdominal pain requiring~     surgical intervention. In the current era, with diagnostic imaging technique like Computed~     Tomography (CT), negative appendectomy rates have been greatly reduced. However, the~     radiation risk with CT poses as a concern. Rules for clinical decision guiding CT utilization~     is thus essential to minimize unnecessary CT scans, which not only poses a radiation risk but~     also contributes to increased healthcare costs.~      Through the development of an algorithm based on Alvarado Score for the management of acute~     appendicitis, investigators hope to reduce CT utilization with an acceptable negative~     appendectomy rate, and hence reducing unnecessary radiation and the healthcare costs~     involved.~   "
18549|NCT03324152|"~     Polymyositis and dermatomyositis are rare inflammatory systemic conditions. Reduced muscle~     function is a cardinal symptom and lung involvement is very common. Knowledge of heart~     involvement in these patients is very limited, as is knowledge of exercise effects in recent~     onset, active disease.~      The aim of this project is to investigate effects of high-intensity interval training (HIIT)~     compared to standard low-intensity home exercise as to tolerance, physical capacity, quality~     of life, depression, disease activity, inflammation, muscle mass/fat mass, muscle metabolism~     and heart function in patients with recent onset, active polymyositis and dermatomyositis.~      This is a randomized controlled trial. Muscle biopsies are taken at time of diagnosis and~     after 12 weeks of exercise. Muscle biopsies will be analyzed as to baseline kynurenine~     pathway, calcium release, gene expression and inflammatory infiltrates and as to changes in~     these parameters following exercise. Muscle function (primary outcome), maximal oxygen~     uptake, muscle mass/fat mass, disease activity, systolic and diastolic heart function, as~     well as quality of life and depression is measured at baseline and after 12 weeks of~     exercise. After all assessments, patients are randomized to HIIT or standard low-intensity~     home exercise.~      The HIIT group will perform 6 sets of 30-60 second biking bouts reaching 85-100% of maximal~     heart rate, in combination with strength training, three days a week for 12 weeks. The~     control group will perform a standardized home exercise program five days a week for 12~     weeks. After 12 weeks, all assessments are preformed again. If the HIIT is well tolerated,~     patients in the control group will be invited to HIIT exercise according to the same~     protocol. Clinical assessments will be performed at 3, 6 and 9 months follow-up in an open~     extension.~      This study will improve our understanding of heart function, muscle metabolism as well as~     tolerance and effects of intensive exercise as well as heart function early in the disease~     course and could also improve treatment and prognosis in patients with polymyositis and~     dermatomyositis.~   "
18550|NCT03324139|"~     TREATMENT OF INTRAUTERINE GROWTH RESTRICTION WITH LOW MOLECULAR WEIGHT HEPARIN.~   "
18551|NCT03324126|"~     Objectives: To compare the effects of two different methods of individualized protein~     fortification of breast milk on the early growth of VLBW preterm infants.~      Design: VLBW preterm infants ≤ 32 weeks of gestational age were included in the study and~     randomized into two groups according to the method of breast milk fortification. In the~     targeted protein fortification group, breast milk samples were analyzed daily via~     mid-infrared spectroscopy and additional protein was provided to maintain an intake of 4.5~     g/kg/day. In the adjustable protein fortification group, blood urea nitrogen (BUN) levels~     were monitored weekly, and if the level was < 5 mg/dL, the amount of protein fortification~     was gradually increased to an estimated maximum level of 4.5 g/kg/day, as per the policy of~     neonatal intensive care unit. The cumulative amounts of protein, energy, fat, and~     carbohydrate given to infants prior to study commencement and during the study period were~     calculated. Anthropometric measurements were performed in both groups weekly for 4 weeks to~     compare their growth, and blood data including pH, base deficit, and urea, creatinine, and~     albumin levels were collected.~   "
18552|NCT03324113|"~     Primary Objective:~        -  To evaluate tolerability and safety of SAR408701 when administered as a single agent~          according to the investigational medicinal product (IMP) related dose limiting~          toxicities (DLTs) to determine the recommended dose (RD) of SAR408701 in Japanese~          patients with advanced malignant solid tumors (dose-escalation part).~        -  To evaluate tolerability and safety of SAR408701 in combination with other anti-tumor~          drug according to the IMP related DLTs to determine RD of SAR408701 in Japanese patients~          with locally advanced or metastatic colorectal cancer (CRC) (combination part).~      Secondary Objectives:~        -  To characterize the overall safety profile of SAR408701 monotherapy and in combination~          with other anti-tumor drug.~        -  To characterize the pharmacokinetic (PK) profile of SAR408701 and its metabolites, and~          TAS-102 components (trifluridine and tipiracil).~        -  To evaluate the pharmacodynamic (PDy) effect of SAR408701 on levels of circulating~          carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5).~        -  To assess preliminary efficacy according to Response Evaluation Criteria in Solid Tumor~          (RECIST) 1.1 criteria and other indicators of antitumor activity.~        -  To assess the potential immunogenicity of SAR408701.~   "
18553|NCT03324100|"~     Nasal mucus and nasal epithelium are the first defense barriers against allergens. Various~     proteins are found in nasal mucus that play a role in allergic rhinitis and reflect immune~     response to allergen exposure. The difference in the proteomic profile of allergic rhinitis~     patients and healthy controls can give insight about how the response works and which~     proteins could lead to either enhanced immune reaction or to defense response like~     augmentation of epithelial integrity. It is also known that the airway epithelium plays a~     crucial role in the regulation of airway immune responses and inflammation. Gene expression~     profiling is widely used to analyses complex disease. For the airway epithelium gene~     expression profile in diseased and healthy state as well as in baseline and provoked state~     can clarify the mechanism of defense reactions and the course of inflammatory processes.~     Nasal mucus proteins as consequence of different gene expression can be seen as part of the~     end products of this complex mechanisms and interactions between allergens and the~     epithelium.~      Nasal mucus proteins have different origins and production sites and gene expression does not~     necessarily result in functional metabolites. The aim of this proposed project is to try and~     analyze in a holistic proteomic approach the response to allergen on a genetic/genomic level~     from the nasal epithelium to protein/proteomic level in nasal mucus. This analysis gives us~     insight of how the different gene expression profiles result in a protein expression and~     further clarifies which proteins are directly originate from the epithelium and which are~     result of plasma exudation or underlie different regulatory processes.~      From allergic rhinitis patients and healthy controls nasal mucus, nasal mucosa, and serum~     will be obtained. Nasal mucus will be collected with a special suction device equipped with a~     mucus trap from the middle meatus under endoscopic control without touching the mucosa. Nasal~     mucosa will be obtained through nasal brushes under local anesthesia and put into primary~     culture. Serum prepared from blood samples. Patients with grass or tree pollen allergy will~     be included and allergic state will be determined by skin prick tests and RAST~     (Radio-Allergo-Sorbent-test). The aimed for sample size will be 15 patients per group.~     Samples will be obtained in and out of pollen season. Allergic patients will fill out a~     symptom score and samples will be taken when symptoms are strong (in pollen season) and~     disappeared (out of pollen season). For healthy controls the time point of sample taking will~     be correlated to the allergic rhinitis patients to have a similar pollen exposure. Nasal~     mucus will be sent for Liquid Chromatography Tandem mass spectrometry for proteomic analysis~     and from nasal epithelial cells RNA will be isolated and send for Microarray analysis. By an~     integrative omics approach gene and protein expression will be correlated and cross talk~     between nasal mucus and epithelium will be analysed. The identification of key genes or gene~     clusters leads to further identification of key proteins or protein groups as biomarkers that~     could serve for novel therapeutic or diagnostic strategies in allergic rhinitis. The~     integrative omic approach downsizes the potential candidates since the focus lies on~     epithelial gene expression and their protein products and excludes proteins that are highly~     abundant without direct correlation to allergen exposure e.g. through plasma exudation.~     Moreover, the genomic and proteomic analysis could explain in more detail how the barrier of~     mucus and epithelium are affected by allergen exposure. The comparison to healthy controls~     and the longitudinal changes throughout the season further sheds light on how these~     individuals react upon allergen exposure and how this could lead to prevention of~     sensitization.~   "
18554|NCT03324087|"~     Immune thrombocytopenia (ITP) is a heterogeneous disorder with variable clinical~     symptomsHealth related quality of life (HRQoL) could be considered in ITP, as in numerous~     chronic diseases, as a method to provide information about the effects of medical~     interventions. Symptoms of ITP, such as spontaneous bruising, menorrhagia, mucosal bleeding~     and prolonged bleeding with injury, may significantly affect HRQoL in ITP subjects.~     Treatments for chronic ITP can also be associated with substantial side effects. Restoring~     and/or maintaining quality of life should be an important goal of treatment. We conducted a~     real-world multicenter study using SF-36 and ITP-PAQ questionnaires to assess the HRQoL in~     patients with ITP in the real world, and analyze the influencing factors of HRQoL so as to~     provide a sufficient basis for clinical decision making.~   "
18556|NCT03324061|"~     Clinical study designed to assess the plasma pharmacokinetic profile and tolerability of~     Fulvestrant for Injectable Suspension after a single IM dose of Fulvestrant for Injectable~     Suspension compared to the reference product, Faslodex in healthy female subjects.~   "
18557|NCT03324048|"~     Anxiety is an emotional disorder. It's a painful concern caused by uncertainty. It is a~     complex phenomenon misunderstood in spite of medical progress. Relaxation is a technical for~     reduce anxiety and is effective and safe. Previous study demonstrated the impact of session~     relaxation on the autonomous nervous system by the heart rate variability.~      Primary objective of this new study is to demonstrate a link between heart rate variability~     and reduced anxiety during relaxation session.~   "
18558|NCT03324035|"~     Despite large efforts to eradicate leprosy, this curable mycobacterial infection still~     affects 250,000 new individuals annually. Half of the globe's leprosy patients live in Brazil~     and India. In 2013, 33,033 new leprosy cases diagnosed in Brazil, with an average incidence~     of 1.05 cases / 10 000 inhabitants. Recently a new concept of care after cure has called~     attention for severe pain in previously treated patients, particularly, neuropathic pain.~     Even so, until now no single drug has been studied for the treatment of pain in this~     patients, and the use of drugs is based on the study of other diseases. We designed the first~     placebo-controlled, double blinded randomized trial in the use of flexible-dose amitriptyline~     (tricyclic antidepressant) for the treatment of neuropathic pain related to leprosy~   "
18559|NCT03324022|"~     Graves' orbitopathy (GO) affects about 50% of patients with Graves' disease (GD), and some~     cannot be cured by current treatments. Orbital fibroblasts involves in the pathogenesis of GO~     by producing glycosaminoglycans and inflammatory cytokines. Since fibroblast growth factors~     (FGFs) binding to FGF receptors (FGFRs) can induce proliferation and differentiation of~     fibroblasts, investigators would like to measure the expression of FGFs and FGFRs in GO~     patients to see if inhibition of FGF-FGFR pathway has potential in treatment.~   "
18560|NCT03324009|"~     Cervical cancer is the leading cause of cancer death among women in Botswana. The burden of~     cervical cancer is largely related to the high prevalence of HIV in Botswana (22%), as HIV is~     known to be a significant risk factor for cervical cancer. Cervical cancer screening is~     life-saving and has been shown to reduce cervical cancer incidence in multiple settings. Yet,~     there is no consensus on appropriate screening algorithms for women living with HIV, across~     resource settings. Botswana is in a unique position, relative to its neighbors in Sub-Saharan~     Africa, in that there exists capacity for advanced screening modalities, including primary~     high risk human papilloma virus (hrHPV) testing and cytology-based screening. To address this~     issue, this study seeks to evaluate two-stage cervical cancer screening algorithms for~     HIV-positive women in Botswana using hrHPV testing. The two protocols include hrHPV testing~     followed by Pap Smear evaluation and hrHPV testing followed by VIA. The evidence generated~     will be critical to guiding cervical cancer screening in HIV-infected women across resource~     settings.~   "
18561|NCT03323996|"~     This study aims to describe the impact of a training in therapeutic education on the relation~     between a caregiver and his/her patients.~      Subjects are recruited among health professionals attending a training in therapeutic~     education. Then they are asked to identify up to 5 of their patients to be contacted by the~     researcher for an interview.~      Individual semi-structured interviews are conducted with 20 duo caregivers / patients~     before the training, 1 month and 6 months after the training.~   "
18562|NCT03323983|"~     Recent improvements in cystic fibrosis management have enabled an important subset of~     patients to maintain normal spirometry. Nevertheless, even in these patients with normal~     spirometry, chest computed tomography (CT) might identify structural lung abnormalities such~     as bronchiectasis, mucus plugging, bronchiolitis and air trapping.~      Lung clearance index (LCI) has been shown to correlate well with structural pulmonary~     alterations seen on CT even in CF patients with well-preserved spirometry. In cystic~     fibrosis, a high LCI is associated with a worse feeling of illness assessed by the Cystic~     Fibrosis Questionnaire-Revised (CFQ-R). School-aged CF patients with normal spirometry also~     have normal aerobic function as assessed by peak oxygen uptake (V̇O2) measured during~     symptom-limited incremental cardiopulmonary exercise test. However, the ability of LCI to~     predict ventilatory abnormalities appearing at exercise in CF patients has not been~     investigated. The investigators therefore aimed to compare physiological parameters at~     exercise between CF patients with elevated LCI (i.e., LCI above the upper limit of normal~     [ULN]) and patients with normal LCI, all with preserved spirometry.~   "
18563|NCT03323970|"~     This study aimed to describe and understand the decision making process in neonatology in~     situations of limiting of withdraw life sustaining treatments, by conducting interviews with~     physicians from one neonatology unit.~   "
18564|NCT03323957|"~     A large number of children experience undernutrition related to or resulting from their~     illness. The NHS has recently published standards which state that all patients should be~     screened for undernutrition on admission and periodically during their stay at hospital.~     Although, recent studies have attempted to develop appropriate nutritional screening tool for~     children on admission, there is no agreement concerning the most appropriate criteria to be~     used and they have not been validated for use in infants. The project team have developed a~     preliminary tool that would be both simple and quick to use in order to identify infants who~     are either undernourished or at risk of undernutrition on admission and who would benefit~     from referral for full nutritional assessment by a dietician.~      The purpose of this study is establish whether an infant Paediatric Yorkhill Malnutrition~     Score for infants would be able to distinguish infants who are well-nourished from those~     undernourished or at risk of undernutrition. The researchers will recruit all newly admitted~     patients ( 210 infants with low, medium, and high risk of undernutrition) from selected wards~     at the Royal Hospital for Sick Children Glasgow. The result from the infant screening tool~     will be compared with the rating using the longer Subjective Global Nutritional Assessment to~     test the ability of Infant Screening Tool to identify infants at high risk of malnutrition.~     The researcher will also measure the fat store using skinfolds and will compare the results~     among those rated high or low risk by the new tool. Finally, the utility of iPYMS score,~     growth trajectory, body mass index and behaviour questionnaire as predictors of low adiposity~     and stunting will be compared.~   "
18565|NCT03323944|"~     This study will evaluate an immunotherapy approach to pancreatic cancer, where patients' own~     immune cells are engineered to treat their cancer. Specifically, the study will determine the~     safety and feasibility of intravenous administration of transduced huCART-meso cells in~     patients with histologically confirmed unresectable or metastatic pancreatic adenocarcinoma,~     with and without cyclophosphamide as lymphodepleting chemotherapy.~   "
18566|NCT03323931|"~     This trial will test the efficacy of robot-enhanced interventions for developing social~     skills in children with Autism Spectrum Disorders (ASD). The study will compare, in an~     equivalence design, an innovative intervention delivered by a semi-autonomous robotic agent~     with standard behavioral intervention. The target group is children between 3 and 6 years old~     which will be randomly allocated to one of the two treatments. Each treatment will be~     delivered over 8 bi-weekly sessions of 45 minutes each.~   "
18567|NCT03323918|"~     This randomised-controlled trial will assess the effect of an early intervention on the~     social-communicative abilities and brain activity of preschoolers with autism spectrum~     disorder (ASD). The children´s social-communicative abilities and the related brain activity~     will be evaluated at three time points: before the start of the intervention~     (pre-intervention), immediately after its conclusion (post-intervention) and several weeks~     after its conclusion (follow-up).~   "
18568|NCT03323905|"~     Single arm, first-in human feasibility study using the Symphony - MRI guided focused~     ultrasound system for the treatment of leiomyomas. The study is expected to accrue over 12~     months. This study will help determine the feasibility to ablate leiomyomas, as measured by~     MR thermometry and contrast enhanced imaging. In addition, the study will look at the~     efficacy and safety of the treatment, as measured by the reduction in fibroid size and~     reduction in symptom severity score and adverse events. This study will help develop future~     pivotal trials using the same device.~   "
18569|NCT03323892|"~     The aim the investigators study is to analyze the embryo development if oocytes of the~     participants are injected with sperm from a longer or shorter (2 hours) abstinence duration.~   "
18570|NCT03323879|"~     This is a dose finding Phase I/II study of combined focused LDR brachytherapy boost with~     whole gland single fraction HDR for men with low and intermediate risk prostate cancer and~     Dominant Intraprostatic Lesion (DIL) visible on multi parametric MRI. Patients will receive~     19 Gy HDR to the whole gland with concurrent LDR brachytherapy boost to the DIL, in a~     sequential dose escalation manner. Primary endpoints are early toxicity.~   "
18571|NCT03323866|"~     The principal objective is to compare the use of mometasone nasal spray to budesonide~     irrigations in patients suffering from CRSwNP who have never been operated.~   "
18572|NCT03323853|"~     • The CARS is based on the Composite International Diagnostic Interview (CIDI), a validated~     instrument for assessing mental health diagnoses (2). According to the CARS manual, The~     Computerized Assessment and Referral System (CARS) is the result of a collaboration between~     the Division on Addiction and the Foundation for Advancing Alcohol Responsibility, a~     nonprofit organization with a focus on preventing driving under the influence (DUI). CARS~     adapts questions from the internationally-recognized Composite International Diagnostic~     Interview (CIDI), a tool designed for lay interviewers who may not have expertise or training~     in mental health assessment. CARS was piloted at 6 different sites in 2016, all in DUI~     populations. As CARS has not been specifically validated on non-DUI populations,~     investigators will collect alcohol history (see below). The CARS self-assessment version~     (CARS-SA) will be utilized in this study.~   "
18573|NCT03323840|"~     This study is designed to explore whether routine measurement of blood pressure by community~     pharmacists can improve patient adherence to blood pressure medications. The study will~     utilize an incentivized care approach, in which patients receive a $10 gift card for every~     time they come to the pharmacy for blood pressure management (up to 2 times/month). The~     investigators hypothesize that the simple process of coming in for a blood pressure~     measurement (without any other scripted interventions, counseling, or consultation) will be~     feasible and sufficient to improve adherence to medications. The investigators will also~     collect preliminary data to help estimate how these hypothetical improvements in adherence~     might result in improved blood pressure control, fewer office visits, and (ultimately) fewer~     adverse cardiovascular outcomes (i.e. heart attacks, strokes, etc).~   "
18574|NCT03323827|"~     The molecular nature of insulin resistance in human muscle is still incompletely defined. Our~     data indicate that acetylation of mitochondrial proteins in humans is regulated by muscle~     contraction and is dysregulated in insulin resistance. Poor function of mitochondria in~     skeletal muscle is a hallmark of insulin resistance in skeletal muscle. We propose to use a~     combination of clinical research and mass spectrometry techniques to determine how the~     cytosolic and mitochondrial protein acetylation is regulated by muscle contraction in insulin~     sensitive and resistant human volunteers. We will test the hypothesis that mitochondrial~     protein acetylation is decreased to a greater degree following a bout of exercise in insulin~     sensitive than in insulin resistant human muscle. Using these techniques we also propose to~     determine how acetylation of mitochondrial adenine nucleotide translocase (ANT1) at lysines~     10, 23, and 92 regulates ANT1 structure and function. Finally, we propose 4) to use a~     combination of molecular modeling and in vitro assays together with the approach developed in~     Aim 3 to characterize the role of acetylation in other mitochondrial proteins. Protein~     targets for this aim will be prioritized based on the potential role of the protein in~     insulin resistance or mitochondrial function as well as dysregulation of its acetylation~     state in insulin resistant muscle.~   "
18575|NCT03323814|"~     This is an observational study to determine if the presentation of sensory stimulation during~     sleep can increase slow-wave activity during non-rapid eye movement sleep~   "
18576|NCT03323801|"~     Men with infertility and normal hormone levels have few options for fertility treatment.~     Previous research suggests that men with infertility may have low levels of the active form~     of Vitamin A, called retinoic acid, in their testes. In a pilot study of 20 men with low~     numbers of sperm (<10 million motile sperm), roughly half the men showed improvement in sperm~     production. Thus, we want to see if retinoic acid administration to men with azoospermia (no~     sperm present) can initiate sperm production.~   "
18577|NCT03323788|"~     We are trying to understand how insulin (a type of hormone in the body that regulates how the~     body regulates how one metabolizes protein and carbohydrates) and exercise alter proteins~     involved in energy production and metabolism in skeletal muscle.~   "
18656|NCT03322735|"~     The purpose of this study is to infusion BCMA CAR-T cells to the patients with relapsed and~     refractory multiple myeloma(MM), to assess the safety and feasibility of this strategy. The~     CAR enables the T cell to recognize and kill the MM cells through the recognition of BCMA, a~     protein expressed of the surface of the malignant plasma cells in MM patients.~   "
18578|NCT03323775|"~     Low back pain is a major contributor to the chronic pain burden in the community. Although~     there are numerous pain generators in the spine, lumbar facet joints are one of the most~     common sources of pain. A variety of measures such as physiotherapy, oral analgesics and~     minimally invasive injections are used to treat lumbar facet joint pain.~      Facet joint steroid injections and radiofrequency denervations of the facet joint are the~     most commonly performed minimally invasive pain procedures for lumbar facet joint pain.~     Radiofrequency denervation is carried out by thermal lesioning of the medial branches that~     supply the facet joints. Conventionally two medial branches have been shown to innervate one~     facet joint and based on this, the norm is to lesion two nerves to denervate one facet joint.~     However, there is some variation in the nerve supply which may account for failure or false~     negative results of the diagnostic blocks.~      The aim of the present study is to explore the feasibility of sensory mapping, thereby~     referral pattern of the lumbar medial branches using suprathreshold stimulation and to~     correlate the referral patterns with painful areas in the back and leg. It will also test if~     the present method of lesioning two nerves to denervate one facet joint is appropriate.~   "
18579|NCT03323762|"~     The aim of this pilot cohort study is to investigate whether treatment with remote ischemic~     conditioning (RIC) has a beneficial effect on blood pressure as well as the immune system in~     first-line pregnant women with newly diagnosed hypertension (> 140/90 mm Hg) or pre-eclampsia~     before gestational week 37.~   "
18580|NCT03323749|"~     This is a multicenter phase 3 randomized, double-blind, parallel-group, placebo-controlled~     trial to evaluate the safety and efficacy of daily subcutaneous injections of elamipretide in~     subjects with primary mitochondrial myopathy. This will be followed by an open-label~     treatment extension.~   "
18581|NCT03323723|"~     This study is an interventional, single arm, multi-center study. It will be conducted at~     sites in the northeastern United States. The protocol will be approved by Chesapeake IRB or~     applicable local IRBs. The sample size will consist of approximately 50 participants.~     Participants will undergo an initial control period in which preweighed pads will be worn for~     7 consecutive days for 12 hours. This will be followed by device usage for 14 consecutive~     days where participants will wear both device and preweighed pads simultaneously. for 12~     hours.~   "
18582|NCT03323710|"~     The study aims to assess antineoplastic efficacy, safety, influence on quality of life and~     disease-related stress of propranolol taken in combination with sunitinib in previously~     untreated metastatic renal cell carcinoma~   "
18583|NCT03323697|"~     Anxiety and depression are currently among the ten most important public health concerns, and~     in recent years, have reached epidemic proportions. Anxiety is recognized as the main risk~     factor for many diseases including cardiovascular, metabolic and neuropsychiatric disorders.~     Current anxiolytic medications have a relatively low success rate (~50%) and are associated~     with many deleterious side-effects. The investigators aim to investigate the efficacy,~     safety, and tolerability of a novel herbal treatment on anxiety and depression symptoms in a~     6-week double-blind randomized trial.~   "
18584|NCT03323684|"~     In laparoscopic cholecystectomy, overall pain is a conglomerate of three different and~     clinically separate components: incisional pain (somatic pain) due to trocar insertion sites,~     visceral pain (deep intra abdominal pain), and shoulder pain due to peritoneal stretching and~     diaphragmatic irritation associated with carbon dioxide insufflation. Moreover, it has been~     hypothesized that intense acute pain after laparoscopic cholecystectomy may predict~     development of chronic pain (e.g., postlaparoscopic cholecystectomy syndrome). Without~     effective treatment, this ongoing pain may delay recovery, mandate inpatient admission, and~     thereby increase the cost of such care.~      Recently, the uses of peripheral axial blocks that deliver local anesthetic into the~     transversus abdominis fascial plane have become popular for operations that involve~     incision(s) of the abdominal wall. Thus, the Transversus Abdominis plane (TAP) block has been~     shown to reduce perioperative opioid use in elective abdominal surgery, including open~     appendicectomy, laparotomy, and laparoscopic cholecystectomy. However, the efficacy of the~     TAP block is reportedly only reliable in providing analgesia below the umbilicus. The~     ultrasound-guided subcostal transversus abdominis (STA) block is a recently described~     variation on the TAP block which produces reliable supraumbilical analgesia. Deposition of~     local anesthetic in this plane has shown to block dermatomes T6 to T10 with an occasional~     spread to T12. This variant will be discussed in our study.~      Currently, the Quadratus Lumborum block (QL block) is performed as one of the perioperative~     pain management procedures for all generations (pediatrics, pregnant, and adult) undergoing~     abdominal surgery. The local anesthetic injected via the approach of the posterior QL block (~     QL 2 block ) can more easily extend beyond the TAP to the thoracic paravertebral space or the~     thoracolumbar plane, the posterior QL block entails a broader sensory-level analgesic and may~     generate analgesia from T7 to L1. Use of posterior QL block in laparoscopic cholecystectomy~     has not been investigated before and it is the variant that will be discussed in our study.~   "
18585|NCT03323671|"~     Preemptive analgesia before the release of pain mediators~   "
18586|NCT03323658|"~     This phase I trial studies the side effects and best dose of bexarotene in preventing breast~     cancer in patients at high risk for breast cancer. Drugs used in chemotherapy, such as~     bexarotene, work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading.~   "
18587|NCT03323645|"~     To establish the Prosthetics Registry and Outcomes in Urology at Duke (PROUD) which will~     serve as a retro- and prospective data repository that our team will use to optimize patient~     satisfaction, lower cost and reduce morbidity associated with penile prosthesis implantation.~     The study team will collect retrospective data from subjects at Duke University and Duke~     Raleigh Hospitals who have undergone genitourinary prosthesis implantation from January 1,~     1996 onward. Prospective data will only be collected from patients seeking care with Dr.~     Lentz in Duke Raleigh.~   "
18588|NCT03323632|"~     The purpose of this study is to examine the efficacy of MyndMove therapy in the early~     sub-acute, late sub-acute and chronic post-stroke patients. Other objectives include~     assessing the required doses of electrical current amplitudes, the usability of the device,~     and examining the overall safety.~   "
18619|NCT03323216|"~     The primary aim of the current study is a better understanding of the role of Type 2 Diabetes~     Mellitus (T2DM) in heart failure and, in particular, changes in cardiac metabolism, which may~     contribute to heart failure. Various biomarkers in the coronary artery blood, as well as in~     the arterial and peripheral venous blood, are to be identified for this purpose. Included are~     patients with and without T2DM, who have a clinically indicated and guidance-appropriate~     Cardiac Resynchronisation Therapy (CRT) implantation due to their cardiac insufficiency.~      Not all patients currently benefit from the implantation of a CRT system (so-called~     non-responder). Despite narrow inclusion criteria, these non-responders cannot be unmasked~     in advance of the implantation. A further aim of this study is to identify biomarkers, which~     can be determined in advance of implantation to differentiate between responders and~     non-responders.~   "
18589|NCT03323619|"~     Aortic stenosis is a frequent valvulopathy in Europe and North America. It occurs mainly over~     65 years (2-7% of the population over 65 years). Treatment of symptomatic stenosis is an~     indication of aortic valve replacement. For patients with high surgical risk (EuroSCORE II>~     6), TAVI (Transcatheter Aortic Valve Implantation) is recommended. This type of procedure~     concerns elderly patients (75-80 years on average in the literature) therefore the anesthesia~     technique must be optimal. The postoperative complications are, on the one hand,~     well-described surgical complications (Cardiogenic shock, bleeding, rhythm disorders, renal~     insufficiency) and, on the other hand, those related to anesthesia which are less well~     characterized. There is no consensus on best anesthesia technique for TAVI procedure~     managment. Between teams practices are different. It may consist of general anesthesia (GA)~     or local anesthesia with sedation (LASed). Elderly anesthesia has specific complications,~     including acute cerebral disturbances (delirium) usually occurring within 24 to 48 hours~     postoperatively and up to 7 days. It is recommended to screen delirium for patients admitted~     in intensive care using the CAM-ICU scale. The aim of the study is to observe the impact of~     the anesthesia technique (GA versus LASed) on delirium in post-operative aortic valve~     replacement with TAVI procedure~   "
18590|NCT03323606|"~     Many problem gamblers are also problem drinkers,with lifetime prevalence in nationally~     representative samples ranging from 45% to 73%. Heavy drinking often occurs while problem~     gamblers are engaging in gambling activities, resulting in increased risky gambling~     behaviour. Further, co-occurring problem drinking negatively impacts on the treatment~     outcomes of problem gamblers. Thus, targeting problem drinking among problem gamblers may~     have the dual benefits of reducing both the problem drinking itself, and of acting as a~     mediator for reductions in problem gambling behaviour. The present study seeks to determine~     whether providing simultaneous access to help for gambling and drinking is of benefit for~     those with these co-occurring problems.~   "
18591|NCT03323593|"~     Intranasal dexmedetomidine has been studied and used in children for premedication before~     anaesthesia or fro sedation. It can be administered by simple dripping or by Mucosal~     Atomization Device (MAD®).~      Since MAD® delivers intranasal medication in a fine mist, it is possible that absorption and~     bioavailability would be better compares to simple dripping method. To date no~     pharmacokinetic information of intranasal dexmedetomidine delivered by either method is~     available. This investigation is designed to compare the bioavailablity of intranasal~     dexmedetomidine deliver via simple dipping with tuberculine syringe and MAD® in healthy~     adults.~   "
18592|NCT03323580|"~     Whether a fluid protocol aiming for cardiac output augmentation or fluid restriction is~     favorable to post-craniotomy outcomes such as brain edema remains uncertain. To our~     knowledge, there has been no extensive and quantitative analysis of brain edema following~     SVV-based GDFT in neurosurgical patients with malignant supratentorial glioma. So the study~     aima to observe the effect of the stroke volume variation-based GDFT on the postoperative~     brain edema and decrease the incidence of postoperative complications in neurosurgical~     patients with malignant supratentorial gliomas.~   "
18593|NCT03323567|"~     An intramusclular injection of three solutions were performed( collagen, lidocaine, saline)~     in musculoskeletal trigger points, in patients suffering from temporomandibular~     disorders(TMD). Best results were observed in collagen group: reduction of 59,2% sEMG~     activity of masseter muscles and 53,75% reduction of pain intensity in VAS scale.~   "
18594|NCT03323554|"~     Few surgical methods to treat male stress urinary incontinence have been assessed in~     comparative, randomised interventional studies.~      Ustrap is a new adjustable-pressure 4-arm device. The artificial sphincter is currently~     considered the gold standard device in this field.~      The aim of this randomised prospective international study is to assess the efficacy and~     safety of the Ustrap® device comparatively with an artificial sphincter (AMS800) in the~     treatment of stress urinary incontinence following prostate removal in cancer patients.~   "
18595|NCT03323541|"~     There are limited data concerning the use of biosimilars of filgrastim in autologous stem~     cell transplantation (ASCT). This study aimed to evaluate G-CSF efficiency and safety (based~     on haemograms, transfusion needs and complications) of two biosimilars (Zarzio and~     Ratiograstim®) compared to those of Neupogen® for our patients who underwent ASCT.~   "
18596|NCT03323528|"~     The aim of this multi-center, randomized, double-blind, placebo-controlled trial is to~     compare the efficacy and safety of Dorithricin® lozenge - a triple combination of 0.5 mg~     tyrothricin, 1.0 mg benzalkonium chloride, and 1.5 mg benzocaine - in repeat dosing for 3~     days to matched placebo lozenges in the treatment of acute pharyngitis in adults.~   "
18597|NCT03323502|"~     Nursing home (NH) patients with Alzheimer's disease and related dementias often receive~     unwanted, burdensome treatments such as hospitalization. Advance care planning (ACP) is a key~     strategy to support patients and family-caregivers in making informed decisions and ensuring~     treatment preferences are proactively known and honored. The ACP Specialist Program will~     improve care and reduce unwanted, burdensome hospitalizations through improved ACP~     procedures, standardized staff education on ACP, and systematic ACP facilitation delivered by~     existing NH staff.~   "
18598|NCT03323489|"~     Many cancer patients, especially those with pancreatic cancer, suffer from severe lower back~     / upper abdominal pain. This pain is often poorly managed with standard treatments; the doses~     of painkiller required often induce side effects, whereas nerve block procedures (where a~     needle is deeply inserted into the back) are both invasive and of limited benefit.~      This clinical trial investigates a unique novel approach in which high-dose radiation~     (radiosurgery) is focused on the offending nerve bundle (the celiac plexus) in the posterior~     abdomen. Preliminary results from a single institution pilot trial are very promising: pain~     relief is substantial and side effects minimal. In this multi-center clinical trial, patients~     will be accrued and receive treatment at several international locations.~      Main aim of the study:~      Establish the safety and efficacy of the treatment in the multi-center setting.~      This trial will bring pain relief to cancer sufferers and improve current acceptable standard~     of care. The trial resonates with the Gateway mission of promoting new treatments that~     directly benefit people living with cancer, enhancing their wellbeing, and consequently~     decreasing the fear associated with a cancer diagnosis.~   "
18620|NCT03323203|"~     To investigate the relationship of tissue oxygenation of different organs and tissue beds~     (e.g., a tissue bed on the arm vs. leg vs. flank tissue bed(s) and renal tissue bed, and thus~     can be used as a surrogate of renal tissue oxygenation monitoring.~   "
18599|NCT03323476|"~     This prospective randomized trial aims to evaluate the feasibility, risk and benefit of the~     discontinuation of immunosuppressive maintenance treatments in AAV (Antineutrophil~     Cytoplasmic Autoantibodies (ANCA)-associated vasculitis) patients who have reached ESRD~     (end-stage renal disease). Our hypothesis is that discontinuation of immunosuppressive~     therapy in AAV patients with ESRD will not expose these patients to an excessive risk of~     extra-renal AAV relapse, while reducing the rate of complications due to immunosuppression,~     particularly infections.~      Patients with ESRD related to AAV will be randomized into 2 arms:~      arm 1: discontinuation (or not initiation) of maintenance treatment (Experimental group) arm~     2: maintenance (or initiation) of immunosuppressive treatment (Control group).~      The main objective of this study is to demonstrate a superiority of immunosuppression~     discontinuation in ESRD-AAV patients compared to standard maintenance immunosuppressive~     therapy in terms of severe prejudicial event-free survival at 24 months. The second~     objectives include the frequency of major and minor relapses, of infectious episodes and~     leukopenia in both groups and the establishment of a prospective database regarding the~     outcome of ESRD-AAV patients.~   "
18600|NCT03323463|"~     The purpose of this study is to demonstrate that participants with HPV positive and hypoxia~     negative T1-@N / 1-2b oropharyngeal squamous cell carcinoma receiving a major de-escalated~     radiation therapy with 2 cycles of standard chemotherapy is not inferior to comparable~     subjects treated with the current standard chemoradiation.~   "
18601|NCT03323450|"~     To investigate a computer-based Cognitive Remediation Therapy (CRT) for brain tumor patients~     at the Massey Cancer Center on measures of cognitive functioning (e.g., working memory,~     attention, processing speed, language, visuospatial functioning, immediate and delayed~     memory, or executive functioning) over time.~   "
18602|NCT03323437|"~     Schizophrenia (SZ) is a highly debilitating neuropsychiatric disorder of young adulthood~     onset and a leading cause of disability worldwide. While treatments delivered at early stages~     of the disorder may be effective at reducing psychosis or altering the course of the disease,~     there are currently no biomarkers capable of identifying subjects in early stages of SZ who~     are likely to respond to treatment and would be good candidates for available proactive,~     symptomatic or future disease-modifying treatments; or those who would not respond and can be~     spared unnecessary medication exposure. The lack of these vitally important biomarkers~     provides a compelling rationale for the present multidisciplinary research project, which~     aims to develop and validate highly promising noninvasive and objective proton magnetic~     resonance spectroscopy (1H MRS)-based biomarkers for monitoring treatment response in early~     stages of SZ. In support of the viability of this overall objective is a large body of data,~     reported by the applicants and others, that show (a) that levels of glutamate (Glu) and -~     aminobutyric acid (GABA) - respectively, the major excitatory and inhibitory amino acid~     neurotransmitter systems - are abnormally elevated in medication-naïve and unmedicated first~     episode and chronic SZ patients; (b) that the effect of treatment with antipsychotic~     medications in these populations may be to lower or normalize brain levels of both Glu and~     GABA. To investigate the potential of these in vivo brain Glu and GABA abnormalities to serve~     as biomarkers of treatment response in early-stage SZ, the applicants propose to use 1H MRS~     to measure Glu and GABA levels in the largest cohort of medication-free SZ subjects to date,~     at baseline and following 4 weeks of antipsychotic treatment.~   "
18603|NCT03323424|"~     The proposed theory is based on combination of radiation therapy with usual targeted~     therapies capable of ADCC (Antibody-Dependant Cell Cytotoxicity). This association could~     enhance in a additive/synergistic way the benefic impact of immune system activation on tumor~     control. Stereotactic Body Radio-Therapy (SBRT) will be combined with the first line~     chemotherapy for metastatic breast, colorectal or VADS (upper aerodigestive tract) cancers.~     The IRAM study objective is to highlight a possible abscopal effect of this combination for~     metastatic cancer patients.~   "
18604|NCT03323411|"~     In a community-based approach, the investigators long-term goal is to empower African~     American family caregivers who are designated healthcare proxies to make informed end-of-life~     treatment decisions for participants with moderate to severe dementia before a~     life-threatening medical crisis occurs.~   "
18605|NCT03323398|"~     This clinical study will assess the safety and tolerability of escalating intratumoral doses~     of mRNA 2416 in patients with relapsed/refractory solid tumor malignancies or lymphoma~   "
18606|NCT03323385|"~     The primary objective of this study is to evaluate the safety and tolerability of~     preoperative dosing of N1539 30 mg in subjects undergoing colorectal surgery, including~     clinical laboratory tests, wound healing evaluation, incidence of anastomotic leaks, and~     incidence of Adverse Events (AEs) and Serious AEs (SAEs).~   "
18607|NCT03323372|"~     The aim of this randomized, double-blind controlled clinical study was to evaluate the~     absolute risk and intensity of sensitivity to dental bleaching in adults on the application~     of two different gels based on potassium nitrate and sodium fluoride from a prospective~     randomized clinical study.~   "
18608|NCT03323359|"~     -  Previous in vitro and in vivo studies detected the Hemopatch Sealing Hemostat® to be a~          new versatile, self-adhering hemostatic sealing pad consisting of a polyethylene~          glycol-coated collagen.~        -  Initial study assessed that Hemopatch Sealing Hemostat® can be applied to seal almost~          any bleeding surface encountered during a range of procedures. The Authors shown that~          the device is eminently capable in both via laparotomy and laparoscopic approaches, and~          in patients with impaired coagulation or highly variable anatomies. They support the~          ease-of-use, application, and immediate hemostatic effect of the patch across a broad~          range of surgical settings and clinical applications, including solid organ,~          gastrointestinal, biliopancreatic, endocrine, cardiovascular, and urologic surgeries.~        -  In a recent published case report the authors reported the feasibility in using~          Hemopatch Sealing Hemostat® for the management of a myocardial wound, performing the~          procedure on cardiopulmonary bypass, which meant the patient had to be heparinized.~          Despite these major risk factors for bleeding Hemopatch Sealing Hemostat® managed to~          contain bleeding and seal the wound without needing any suture.~      These initial results lead up to future randomized clinical trials with more extensive~     follow-up to assess which is the real contribution of Hemopatch Sealing Hemostat to reduce~     postoperative bleeding complications in cases where mechanical or energy-driven hemostasis is~     not possible or insufficient.~   "
18609|NCT03323346|"~     The aim of the study is to establish clinical evidence for introducing disulfiram and cooper~     as an active therapy for metastatic breast cancer upon failure of conventional systemic~     and/or locoregional therapies.~      Analyses of the following objectives will be performed in the population of patients with~     metastatic breast cancer:~      Primary efficacy objective:~      To evaluate the efficacy of the treatment by assessment of:~        -  clinical response rate (RR)~        -  clinical benefit rate (CBR)~      Secondary efficacy objectives:~      To evaluate the efficacy of the treatment by assessment of:~        -  time to progression (TTP)~        -  overall survival (OS)~      Pharmacokinetic objectives:~      • to determine pharmacokinetic parameters for disulfiram and its active metabolites~     administered in combination with copper supplements in cancer patient population~      Safety objectives:~      • to describe safety profile of disulfiram administered in combination with copper~     supplements~      Exploratory objectives:~      Parallel analysis to assess (identify) potential candidate surrogate biomarkers of disulfiram~     efficacy, as well as identification (using proteomic, biochemical and molecular genetic~     studies) of potential predictive biomarkers of disulfiram sensitivity or resistance will be~     performed. Surrogate biomarker analysis will focus on in vivo ubiquitin-proteosomal system~     inhibition, cell cycle and DNA damage.~   "
18610|NCT03323333|"~     A brief psychosocial intervention for partners of women affected by or at risk for breast~     cancer and harboring BRCA genetic alterations.~   "
18611|NCT03323320|"~     More than one million of patient receive anti vitamine K treatment which is the main cause of~     hospitalization. About 50 000 patient receive direct oral anticoagulant .~      The aim is to evaluate the patient's level of knowledge about their anticoagulant treatment~     and specially about the side effect~   "
18612|NCT03323307|"~     The purpose of this study is to compare the performance of a prototype optical coherence~     tomography (OCT) machine with currently available high resolution OCT machines.~   "
18613|NCT03323294|"~     The investigators want to learn more about obesity, the development of insulin resistance,~     and Type 2 Diabetes in children. The investigators will do this through collecting~     information about children's health and conducting experiments on a variety of samples.~   "
18614|NCT03323281|"~     It is estimated that approximately 20-25% of diabetic patients will have at least one trophic~     disorder during their period. The appearance of a trophic disorder in a diabetic patient is a~     serious complication, indicating that diabetes is often complicated. The consequences are~     serious for the patient with an impairment of his quality of life, but also for society with~     a high cost in terms of health care costs.~      It should also be noted that diabetes remains the main cause of non-traumatic amputation in~     most developed countries, with amputation often preceded by a trophic disorder. In addition,~     20% of amputees are re-amputated at least once a year. Thus, the consequences of diabetic~     foot injuries are important in human, social and health terms and are the subject of~     increased health care spending.~      Many studies have shown that diabetes is a risk factor for dementia, whether it is~     Alzheimer's disease, Alzheimer's disease or the vascular component or pure vascular dementia.~      However, an understanding of the cognitive mechanisms involved in the management of diabetes~     and in particular in the diabetic foot and its recurrence remains partial and no study has~     integrated the severity of the risk of the foot (evaluated by the podological risk) Specific~     implication of some Cognitive abilities, especially in relation to episodic memory, and~     social cognition integrating decision-making abilities. These specific disorders could have a~     major impact in diabetes follow-up, therapeutic adherence and the risk of developing~     recurrent trophic disorders.~      Thus, the coexistence of diabetes with a mental pathology makes the management of the subject~     more complex and exposes it to more complications.~      In the management of chronic diabetic disease, adherence to treatment is essential. It is~     therefore important to detect the specific effects of this type of personality on the~     prognosis of diabetes and the appearance of foot wounds.~   "
18615|NCT03323268|"~     Cardiogenic shock, the most severe form of acute heart failure, is a critical situation where~     the body cells lack of oxygen because of cardiac dysfunction. The failure of pharmacological~     therapy to maintain adequate perfusion has led to attempts to improve the circulation by the~     use of mechanical circulatory support devices. Peripheral veno-arterial support (PVA-ECMO) is~     the most frequently used device. It consists of extracorporeal circulatory support. Venous~     blood is aspirated via the right atrium and reinjected into the descending aorta via the~     femoral artery. As a consequence of this by-pass, pulmonary artery flow and residual left~     ventricle ejection can fall drastically until zero in the most severe patients. A minimal~     transpulmonary blood flow is crucial to avoid left heart cavities and pulmonary artery and~     left heart cavities thrombosis. The gold standard technique to monitor transpulmonary blood~     flow is right-heart cavities catheterism (Swan-Ganz catheter) but it represents major limits:~     invasive technique, limited duration of utilization because of septic risk, physical limit of~     flow measurement (under 1 liter/minute). End-tidal pressure carbon dioxide (Pet CO2)~     monitoring (or capnography) is a routine and non-invasive measure in ventilated patients.~     Previous studies have shown that changes in PetCO2 can measure changes in cardiac output in~     anesthetized patients and that PetCO2 is a useful index of pulmonary artery blood flow during~     separation from cardiopulmonary bypass. The aim of this study is to demonstrate that PetCO2~     is correlated to transpulmonary blood flow in patients under PVA-ECMO and that exhaled CO2~     can provide an on-line, continuous, and noninvasive monitor of residual outflow from the~     heart during PVA-ECMO.~   "
18616|NCT03323255|"~     This study evaluates the effect of a unique session of inhibitory rTMS (cTBS) over the~     contralesional posterio parietal cortex (PPC) on the spatio-temporal parameters of a pointing~     movement performed by stroke patients with their paretic upper limb. It will also assess the~     effects on the resting motor threshold of both hemispheres and on parietopremotor~     connectivity.~      To achieve theses aims, the real cTBS stimulation will be randomly counterbalanced with a~     SHAM stimulation (in a second session) in a crossover design. Assessments will be performed~     before and after each stimulation session.~   "
18617|NCT03323242|"~     Liver transplantation (LT) is a well-established procedure for the treatment of end stage~     liver disease. Many improvements in the surgical technique have rendered this major operation~     to be carried out safely. Most important operative innovations after the initial introduction~     of LT in the clinical routine by Starzl include the use of veno-venous bypass in LT, the~     piggy back technique with preservation of the recipients' caval and it's modification~     introduced by Belghiti with side to side cavo-caval anastomosis. Nevertheless little~     improvements have been introduced in the surgical technique for tissue preparation and~     sealing of blood vessels during recipient hepatectomy. Due to end stage liver disease and~     recipients' general and coagulatory condition, the hepatectomy carries the risk of severe~     blood loss which can impair the outcome after LT. Usually the recipient hepatectomy is~     carried out as a combination of sharp dissection of the hepatic adhesions to the abdominal~     wall and the diaphragm and clip or suture ligature of small retrohepatic caval vein branches.~      With advances in surgical procedures and equipment, modern technologies have been introduced,~     which shortened operation time and improved surgical outcomes. Exquisite equipment for liver~     parenchyma transection, such as Cavitron ultrasonic surgical aspirator, ultrasonic dissector~     (USD), LigaSure (LS) and Tissue Link can also be used to reduce hemorrhage in liver~     resection. The ultrasonic scalpel (Ethicon) is a new USD that cuts and coagulates tissue with~     ultrasound, using higher frequencies than an ultrasonic aspirator. This device can also serve~     as a grasper and basically involves a blade oscillating at 55 kHz, producing heat and~     coagulation of vessels. Recently, its use and potential advantages in open liver resection~     have been demonstrated. The main technical advance relates to decreased intra-operative~     bleeding. Results of using USD (Harmonic Scalpel) during recipient hepatectomy showed that~     this method is safe compared with conventional knot tying ligation regarding intra- and~     postoperative bleeding rate. The electrothermal bipolar vessel sealing device LS is another~     alternative, which applies electrothermal bipolar coagulation and dissection in one step. The~     LS dissection device is sealing the tissue first before it is divided (both performed with~     the same device). This may prevent severe bleeding. Furthermore, the sealing device is able~     to cope with the small liver veins which can be sealed and divided safely without the need~     for sutures or clips. Especially the latter could interfere with sufficient tangential~     clamping of the inferior caval vein (IVC) for side to side cavo-cavostomy during piggy back~     LT. It was reported that use of LS device for recipient hepatectomy in LT. It was concluded~     that, LS vessel sealing is an efficient method and vessel sealing of caval, portal, and other~     structures can be safely performed in the setting of end-stage liver disease.~      To our knowledge, until now no randomized clinical trial has been conducted to compare~     different dissection methods during recipient hepatectomy. While LS and USD have been proven~     to be used safely in several major surgical procedures, including liver resection, their use~     in liver transplant recipient hepatectomy has not yet been evaluated systematically.~      This trial was designed to compare the potential beneficial effects for the use of the LS~     device and USD for recipient hepatectomy during LT. Furthermore the evaluation of safety and~     practicability of these methods is investigated. Both the duration and the blood loss during~     the total surgery and the hepatectomy phase of transplantation are of interest.~   "
18618|NCT03323229|"~     SatCare is a randomised controlled trial involving rapid standardised ultrasound assessment~     of patients with shock, major trauma, abdominal pain, chest pain or breathlessness in~     emergency ambulances. The scans will take less than 5 minutes and be transmitted to a~     hospital-based expert for review, providing support and instructions for optimal prehospital~     care.~      Five Highland Scottish Ambulance Service ambulances covering areas more than 30 minutes from~     Raigmore Hospital, Inverness, UK, will be equipped with an ultrasound machine (M-Turbo,~     FujiFilm Sonosite) and satellite transmission system plus webcam, and will be deployed in~     real emergency situations. When dispatched to a potentially eligible patient, the attending~     paramedic will contact Raigmore Hospital's emergency department to check the availability of~     an emergency medicine specialist and obtain study group allocation (ultrasound with enhanced~     telecommunications plus usual care versus usual care alone). Following verbal consent from~     the patient, trained paramedics will perform the condition-specific scan protocol in the~     ambulance at the incident site, and transmit the recordings and patient video via satellite~     to the emergency department for specialist analysis. The consultant will give advice on~     patient management via standard ambulance communications systems while it is en route to the~     hospital.~      The remotely supported prehospital ultrasound implementation will be examined in terms of its~     delivery and functioning. An economic evaluation will compare its use with care as usual for~     eligible patients transported by ambulance, modelling the costs and benefits of this service~     expansion and determining optimum use. It is hoped that the results, anticipated to be~     available in 2019, will provide an evidence base for the use of prehospital ultrasound for~     emergency care.~   "
18622|NCT03323177|"~     The proposed study is an extension study to two ongoing double blind, randomized,~     placebo-controlled studies evaluating the effect of gender-specific nutritional~     supplementation on growth of short and lean adolescent boys and girls. The aim of the current~     study is to extend these short term double blind, randomized, placebo controlled studies (one~     in boys and one in girls) and to add an extension study, which will evaluate the long term~     effect of the gender specific nutritional supplementation on final height. Patients~     completing the ongoing studies will be offered to continue treatment with the study formula~     until final height. Patients reluctant to continue to consume the study formula will be~     offered to continue followup only during the extension study without any intervention.~   "
18623|NCT03323164|"~     This study evaluates the possible acute changes in peripapillary blood flow after~     instillation of antiglaucoma medications in patients with primary open angle glaucoma (POAG),~     normal tension glaucoma (NTG), or ocular hypertension (OHTN) using Optical Coherence~     Tomography (OCT) angiography.~   "
18624|NCT03323151|"~     Patients with mantle cell lymphoma (MCL) that has relapsed (come back) or refractory~     (progressed on treatment) will receive ixazomib and ibrutinib.~      Ibrutinib has been approved by the Food and Drug Administration (FDA) as treatment for~     patients with mantle cell lymphoma who have received at least one prior therapy.~      Ixazomib is in a class of medications called proteasome inhibitors. Cancer cells depend on~     proteasome to provide this protein metabolism (turnover) function to regulate their growth~     and survival. Ixazomib disrupts a cancer cells' ability to survive by blocking the proteasome~     and disrupting protein metabolism. This may help to slow down the growth of cancer or may~     cause cancer cells to die.~      The purpose of this study is to see whether the addition of ixazomib to ibrutinib~     chemotherapy is effective in treating people who have relapsed or refractory MCL and to~     examine the side effects associated with ixazomib in combination with ibrutinib.~   "
18625|NCT03323138|"~     Primary angle-closure glaucoma (PACG) is common, phacotrabeculectomy is associated with a~     significant risk of complications.The Ex-PRESS shunt was introduced as a modification to~     trabeculectomy, with the theoretical advantages of reduced complications.Our purpose is to~     perform a prospective study to evaluate the clinical outcomes and safety of the Ex-PRESS~     shunt with cataract surgery for PACG patients coexisting cataract.~   "
18626|NCT03323125|"~     Intro:~      Patients with vitiligo have a reduced protection on depigmented areas. To date, however,~     little is known about photoprotection habits in patients with vitiligo even though these~     patients are thought to have a decreased ability to efficiently protect their skin against~     sun damage. Moreover, exposure to artificial UV is one of the major elements of the treatment~     of vitiligo even though certain phenotypes of vitiligo could be photoinduced.~      Hypothesis The Primary objective is to describe patients behaviour with sun exposition~      The Secondary objectives are:~        -  to assess the link between sun exposition and vitiligo outbreaks~        -  to assess photoprotection habits according to initial phototype and vitiligo severity~          (SA-VES)~        -  To validate a short form of the VIPs questionnaire, a validated burden questionnaire.~      Method We aim to conduct a prospective cross sectional study in patients with Vitiligo with~     the aim to evaluate sun protection habits in patients with vitiligo. For that purpose a~     semi-directed questionnaire to investigate the sun protection behavior of vitiligo patients~     (adults> 18 years of age) have been created by experts in the field. Vitiligo severity will~     be self-assessed by patients using a recently validated patient reported outcome, the SA-VES.~     Consecutive vitiligo patients consulting in the dermatology department of Henri Mondor~     Hospital (Créteil, France) will be proposed to participate the study after having given their~     oral consent. We are planning to enrol 500 patients.~      In a first step, a descriptive analysis will be carried out in order to describe the~     characteristics of the sample. Basic summary statistics, such as proportions, means and~     standard deviations, will be used to characterize the population. In order to identify the~     factors associated with the severity of the disease on the one hand and the phototype on the~     other, comparisons between groups (severe versus non-severe and light phototype versus dark~     phototype) will be carried out by unconditional logistic regression. All potential predictors~     of severity will first be assessed individually, and Odds Ratio (OR), corresponding 95% CIs~     and P values will be calculated. The significance of the OR will be determined by the Wald~     test χ2, and the predictors with P <.20 will then be evaluated using a multivariate analysis~     with a pre-selection procedure. Possible interactions and multi-colinearity will be examined.~     Finally, the quality of fit of the final model will be evaluated using the logistic~     regression diagnostic procedure. P ≤ 0.05 will be considered as statistically significant.~     The Hosmer-Lemeshow test will be carried out to test the suitability of the model.~      Conclusion This study will help to identify gaps in the knowledge of sun protection habits in~     patients with vitiligo.~   "
18627|NCT03323112|"~     This is an investigator-initiated 10 year long open cohort observational study, aiming to~     increase the understanding of the humoral and cellular immunological mechanisms of~     vaccination against influenza, including effects of repeated vaccination, the duration of~     protection, immunity against circulating viruses, as well as factors affecting the~     immunological responses and immunity against other vaccine preventable infectious diseases~     among health care personnel. Influenza vaccination is given according to the normal routine~     of Hospital District of Helsinki and Uusimaa (HUS) occupational health care. Blood samples~     will be collected before vaccination, 5 weeks after vaccination and 6 months after~     vaccination. The analysis will be mainly descriptive.~   "
18628|NCT03323099|"~     The I-STOP-Afib study will test the comparative effectiveness of using N-of-1 trials vs.~     symptom surveillance alone to reduce Atrial Fibrillation (AF) episode frequency and severity~     and improve quality of life for AF patients. The study will involve randomizing almost 500~     paroxysmal AF patients to either AF episode tracking versus engaging in testing the~     relationship between participant-selected triggers and AF episodes utilizing a mobile-app~     based N-of-1 study design. Both groups will complete a validated survey to assess AF~     severity, essentially a measure of quality of life while living with AF, before and after a 3~     month testing period.~   "
18629|NCT03323086|"~     This study will investigate whether BI and technology extenders are feasible and acceptable~     for female patients at a reproductive health center (ages 18-29).~   "
18630|NCT03323073|"~     The primary purpose is to compare with resting fMRI the functional networks of rest (RTS) in~     unipolar depression and in bipolar depression.~      Hypothesis : the main objective of this work is to compare with the rest fMRI the Rest~     Functional Networks (RFN) in the unipolar depression and in the bipolar depression in order~     to identify specific biomarkers for each affection. The general hypothesis of this work is~     that intra- and inter RFN connectivity is different between bipolar patients and unipolar~     patients. Specifically the investigators assume that connectivity within the default mode~     network (including ventral mediofrontal cortex, subgenual cingulate cortex, inferior parietal~     cortex, posterior cingulate cortex) will be increased in unipolar patients compared to~     bipolar patients.~   "
18631|NCT03323060|"~     To assess the safety and performance of the Medrobotics Flex Robotic System and Flex~     Rectoscope for accessing and visualizing the Anus, Rectum, and Distal Colon when used for~     Transanal procedures~   "
18679|NCT03322436|"~     HeartLinc is a non-interventional patient study to demonstrate medical utility of the lncRNA~     to predict HF in AMI patients. 300 patients are expected to be recruited.~   "
18632|NCT03323047|"~     Pediatric patients who are undergoing a tonsillectomy at the Children's hospital will be~     randomly assigned to one of three drug groups: 1) acetaminophen (Tylenol) administered~     pre-operatively and a low dose of anti-inflammatory drug (dexamethasone) administered~     intra-operatively; 2) acetaminophen (Tylenol) administered pre-operatively and a high dose of~     anti-inflammatory drug (dexamethasone) administered intra-operatively; 3) no acetaminophen~     (Tylenol) administered pre-operatively, low dose anti-inflammatory (dexamethasone)~     administered intra-operatively. The present study will evaluate differences in pain~     management and surgical complications across the three groups of drug regimens. Main study~     outcomes include: pain medication administration during surgery, use of pain killers at~     1-week post-operation, subjective pain scores administered in the post-anesthesia care unit~     (PACU) and 1 week postoperation, fluid and food intake, and complication rates (i.e.~     postoperative bleed rate). The hypothesis is that pain will be lowest in the group that~     received Tylenol and high-dose dexamethasone (Group 2).~   "
18633|NCT03323034|"~     This phase I trial studies the side effects and best dose of pevonedistat when giving~     together with irinotecan hydrochloride and temozolomide in treating patients with solid~     tumors or lymphoma that have come back after a period of improvement or that do not respond~     to treatment. Pevonedistat and irinotecan hydrochloride may stop the growth of cancer cells~     by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as~     temozolomide, work in different ways to stop the growth of cancer cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. Giving~     pevonedistat, irinotecan hydrochloride, and temozolomide may work better in treating patients~     with solid tumors or lymphoma.~   "
18634|NCT03323021|"~     After partial nephrectomy, kidney function decreases by about 10% overall and by about 20% in~     the operated kidney. This is primarily due to the loss of healthy parenchymal volume during~     resection of the tumor. In an effort to preserve and regenerate healthy parenchyma during the~     procedure and ultimately renal function after partial nephrectomy, the single center double~     arm single-blinded randomized screening clinical trial will evaluate the ability of human~     amnion/chorion allograft to facilitate the recovery of renal function following robotic~     partial nephrectomy.~   "
18635|NCT03323008|"~     The mission of corrections is to provide care, custody, and control for incarcerated~     individuals. United State prisons are required by constitutional law to provide adequate care~     for growing numbers of older inmates who will likely spend their final days in prison. This~     Phase I project focuses on research and development of highly interactive computer-based~     learning modules for inmate peer caregivers to promote an integrated systems approach to~     enhancing the care of the aged and dying in prisons.~   "
18636|NCT03322995|"~     This is an open-label, phase II study in patients with resectable and borderline resectable~     pancreas cancer.~   "
18637|NCT03322982|"~     A randomized, controlled pilot trial of a dietary intervention vs. wait-list control in~     patients with MS and fatigue for management of their fatigue. The hypothesis of this study is~     that participants following the low-fat study diet will demonstrate a significant reduction~     in fatigue after four months compared to wait list controls.~   "
18638|NCT03322969|"~     For patients undergoing postoperative therapy for locally advanced gastric cancer after~     neoadjuvant chemotherapy, we assessed the utility of graded histologic regression of <50% as~     the criterion of treatment change. Sixty patients will be enrolled to randomize into two~     groups：receiving modified chemotherapy and receiving the original chemotherapy.~   "
18639|NCT03322956|"~     The purpose of this study is to investigate the effect on QoL, PI and the AROM° in patients~     with non-specific chronic low back pain. This after following an episode of 6 weeks 2 times a~     week physiotherapeutic back rehabilitation according to the 4 times T method by orthopedic~     disorder ® (4MTOR®). The results in this research will be analyzed and reported. In this~     study, 7 dependent variables will be independently examined relative to 2 independent~     variables.~   "
18640|NCT03322943|"~     This study evaluates the different response of Ursodeoxycholic Acid in primary biliary~     cholangitis only and primary biliary cholangitis with high immune globulin G or~     aminotransferase at West China Hospital from 2008-2017.~   "
18641|NCT03322930|"~     A new fundus-guided microperimeter, the MP-3S, has been developed by Nidek, Inc. to track the~     fundus of the patient and present stimuli in specific anatomically-defined locations.~     Furthermore, this tracking means that exactly the same locations can be tested on subsequent~     (follow-up) visits. The investigators will use a method called two-color perimetry to map rod~     and cone sensitivity on this device. With this technique, the sensitivity difference~     (blue-red) to chromatic test stimuli can be used to determine whether rods, cones or both~     photoreceptor systems mediate the threshold at a given location in the macula.~   "
18642|NCT03322917|"~     To evaluate the efficacy of autologous platelet-rich plasma eye drops (E-PRP) for the~     treatment of chronic ocular surface syndrome (OSS) following laser in situ keratomileusis~     (LASIK).~   "
18643|NCT03322904|"~     ABSTRACT BACKGROUND The existence of the retinohypothalamic pathway suggests that light may~     influence autonomic outflow activity. The objective of this study was to examine the~     correlation between the estimated iris muscle sympathetic‒parasympathetic area (IRIS) ratio~     and the sympathetic-parasympathetic ratio (low frequency [LF]/high frequency [HF] ratio).~      METHODS The study population consisted of 200 females and 200 males (mean age, 32.4 ± 7.1~     years). The IRIS ratio was determined from digital photographs of the iris in a computer~     setting. The LF/HF ratio was determined from records of heart rate variability obtained using~     a Holter implementation.~   "
18644|NCT03322891|"~     Investigators propose an observational interview study to explore how patients understand~     treatment conversations with their physicians within the framework of health literacy. The~     study team will test whether patients' understanding of treatment options and side effects~     can be improved when patients receive a low literacy educational supplement after meeting~     with their urologist. Investigators will interview a group of newly diagnosed, early stage,~     African American prostate cancer patients.~   "
18680|NCT03322423|"~     This is a single-masked, randomized, cross-over, dispensing, 6- visit pilot study. The~     purpose of this clinical study is to evaluate the performance of two marketed multifocal~     lenses.~   "
24615|NCT03244800|"~     A Phase 2 study with two cohorts of differing doses designed to evaluate the efficacy, safety~     and pharmacokinetics (PK) of MEDI0382 in patients with Type 2 Diabetes Mellitus.~     Approximately 63 subjects will be enrolled across two cohorts.~   "
18645|NCT03322878|"~     Intravenous magnesium has been studied in pediatrics to reduce agitation after sevoflurane~     anesthesia in children undergoing adenotonsillectomy, reduce intraoperative rocuronium~     requirements, prevent laryngospasm and coughing after removal of the endotracheal tube in~     patients undergoing adenotonsillectomy.~      The aim of this study is to investigate the role of intravenous magnesium sulfate on~     postoperative pain management in paediatrics and to compare it with its effect when~     administered caudally in children undergoing lower abdominal surgeries.~   "
18646|NCT03322865|"~     For marginal zone lymphoma (MZL) Rituximab in combination with conventional chemotherapy are~     widely used for those patients who fail local therapy or do not qualify for such. Depending~     on the MZL subtype Rituximab/chemotherapy is able to induce in part long remissions, but do~     not prevent relapse later on. In addition, chemotherapy associated toxicity is often~     problematic in MZL patients, who are mostly of advanced age. Thus, chemotherapy - free~     approaches are highly attractive for this patient group. Rituximab single agent is a widely~     used chemotherapy - free approach in MZL, but was significantly inferior compared to~     Rituximab/chlorambucil in a large randomized prospective clinical trial in treatment naïve~     MZL with a CR rate of 56 % vs. 80%, respectively (P<0.001).Thus, it is the major aim to~     develop chemotherapy - free approaches for MZL, which approach efficacy of~     rituximab/chemotherapy combinations, but avoid chemotherapy associated toxicities. This in~     particular important in MZL as many physicians are reluctant to treat these often elderly~     patients with more intense treatments and prefer single agent therapies in these very often~     well and long responding lymphoma subtype. The type II anti-CD20 antibody Obinutuzumab~     (OBINUTUZUMAB) has demonstrated remarkable activity in follicular lymphoma and superiority to~     Rituximab in combination with chemotherapy in treatment naïve (Gallium trial) and rituximab~     refractory follicular lymphoma (Gadolin trial) as well as in CLL in combination with~     chlorambucil. Based on these observations it is the aim of this study to test the toxicity~     and efficacy of the anti-CD20 antibody Obinutuzumab (OBINUTUZUMAB) in patients with newly~     diagnosed MZL in need of treatment, who are not eligible or failed local therapy, following~     the assumption that this novel anti-CD20 antibody is significantly more effective than~     Rituximab single agent therapy, and avoids chemotherapy - related toxicity.~   "
18647|NCT03322852|"~     In a prospective observational study at a university teaching hospital, blood flow indices~     and serum hormone levels were compared between spontaneous and stimulated cycles in the same~     group of 50 patients with unexplained delayed conception.~   "
18648|NCT03322839|"~     Given today's high prevalence of common mental disorders and related sick leave among~     teachers an urgent need exists for a more sustainable working life for this professional~     group. One way of doing this is by improving schools' social and organizational risk~     management. Recent reports have shown that many schools in Sweden however lack a structured~     approach to the management of social and organizational risks. In 2015, we launched the first~     Swedish occupational health guideline to support a structured prevention of social and~     organizational risks at the workplace with the aim of preventing common mental disorders. The~     long-term goal of this study is to support the implementation of this guideline within~     schools in order to improve social and organizational risk management and in doing so reduce~     risk factors for mental ill-health and related sick days. The objective of the study is to~     fill the current research-to-practice gap by conducting a cluster-randomized controlled trial~     that compares the effectiveness of two implementation strategies for implementing the~     guideline in schools. The strategies that will be compared are training (ARM 1) versus~     training in combination with implementation teams and workshops (ARM 2). Our hypothesis for~     the study is that schools that receive support in implementing the guideline through combined~     strategies are more responsive to working in a structured and systematic manner with the~     management of social and organizational risks than schools that only receive training. The~     trial will be conducted in 30 primary schools in three municipalities in Sweden. All schools~     have agreed to participate. The primary outcomes are adherence to the guideline~     (implementation effectiveness) and self-reported exhaustion among schools personnel~     (intervention effectiveness); the secondary outcomes are risk factors for mental ill-health~     and absenteeism. Data will be collected at baseline, 6, 12 and 24 months by mixed methods~     (i.e. survey, focus-group interviews, observation, and register-data).~   "
18649|NCT03322826|"~     The purpose of this study is to evaluate the impact of systematic sampling of lymph nodes vs.~     lymphadenectomy on outcome according to intraoperative frozen pathology for pulmonary~     invasive adenocarcinoma with ground-glass opacity (GGO) after VATS lobectomy.~   "
18650|NCT03322813|"~     This study is designed to assess the safety and feasibility of using the ExAblate, Type 2 to~     temporarily disrupt the blood brain barrier in non-enhancing suspected glioblastomas. The~     ExAblate Model 4000 Type-2 is intended for use as a tool to disrupt the BBB.~   "
18651|NCT03322800|"~     This study will characterize the pharmacokinetics (PK) of AK0529, the effect of food and~     evaluate the safety of AK0529 in healthy Chinese adult subjects. 50 subjects will be~     randomized to receive a dose level of AK0529 or placebo in five groups. The total study~     duration will be approximately 18-27 days for each subject.~   "
18652|NCT03322787|"~     Current literature clearly shows the benefit of pulmonary rehabilitation in symptomatic COPD~     (Trooster,2005). However, these patients are frequently unable to sustain a work-load~     sufficiently high to obtain a full benefit on exercise tolerance (Trooster,2005). Especially~     in patients with Chronic Respiratory Failure (CRF), the development of hypoxia~     (O'Donnel,2001) and the increase of dead space (Elbehairy,2015) during effort explain the~     out-of-proportion increase in ventilation leading to an early achievement of the ventilatory~     reserve. Recent studies on heated and humidified high flow oxygen (HFO) delivered through~     nasal cannula, show several positive effects on breathing pattern and ventilatory efficiency,~     mostly in critical care setting and at rest (Spoletini,2015). Some recent physiological~     studies have evidenced that high flows of humidified oxygen improve exercise performance in~     patients with COPD and severe oxygen dependency, in part by enhancing oxygenation~     (Chatila,2004). Recently, a pilot study by our group showed that HFO may improve the exercise~     performance in severe COPD patients with ventilatory limitation. This effect is associated to~     an improvement of oxygen saturation (SatO2) and perceived symptoms at iso-time (Cirio,2016).~     No clinical studies are available about the use of HFO during exercise training. The~     investigators hypothesize that, in severe COPD patients with CRF and exercise limitation ,~     the use of HFO could improve the efficiency of ventilation, leading to an increase in the~     patient's exercise performance and outcome.~      Primary aim will be to evaluate in patients COPD with CRF the difference in the endurance~     tolerance improvement (expressed in minutes) after an high intensity training program, at~     iso-FiO2, using HFO with respect to usual oxygen administration by  Venturi Mask .~      Secondary objectives will be to study effectiveness of HFO with respect to Venturi Mask in~     terms of improvement of meters of 6 Minute Walking Test, dyspnea at rest, peripheral and~     respiratory muscle strength,blood gases, motor and respiratory disability,quality of~     life,impact of the disease and patients satisfaction.~   "
18653|NCT03322774|"~     This project will assess the effectiveness of a stepped-care model (i.e. digital Cognitive~     Behavioral Therapy for Insomnia (dCBT-I) followed by face-to-face CBT-I) in improving~     severity of insomnia and sleep outcomes in an insomnia cohort, including those at higher risk~     of depression. This project will also investigate the effectiveness of this stepped-care~     model in prevention of depression and any potential mediation by rumination as a modifiable~     behavior.~   "
18654|NCT03322761|"~     This study seeks to investigate whether early exercise efforts can expand the use of exercise~     in Multiple sclerosis (MS), from symptom treatment only, to early supplementary~     disease-modifying treatment.~      The study will be conducted in a randomized and controlled manner, with single blinding.~     Participants will be allocated to either a systematic aerobic exercise intervention or an~     educational programme on exercise and physical activity. Both interventions will last 1 year,~     and involve a 1 year follow-up period.~      It is hypothesized that early exercise efforts can modify the disease activity and disability~     progression.~   "
18655|NCT03322748|"~     The aim of the study (OVERACT_V1) is to verify if the isometric contraction of ankle~     plantarflexor and Hamstring muscles, induces a significant reduction of overactive bladder~     symptoms in patients with Multiple sclerosis.~   "
26178|NCT03224312|"~     We aimed to assess the target organs damage of hypertention and the occurrence of~     cardiovascular and cerebrovascular events by a long-term regular follow-up, and discuss the~     influences of the risk factors.~   "
18657|NCT03322722|"~     The alimentation of the premature newborn children is one of main thing concerning of nurses~     and pediatricians in neonatology. The absence of common tool of evaluation of the children~     cause a great discrepancy in prescriptions and the practices of the nursing.The aim of this~     study is to estimate the improvement of the food empowerment of the premature newborn~     children after the introduction of a help tool at the food progress which allows to fit the~     prescription of food(supply) to the capacities of the newborn child.~   "
18658|NCT03322709|"~     This study aims to investigate the effect of robot-assisted laparoscopic kidney~     transplantation on kidney injury by measuring biomarkers of kidney injury which are found in~     blood and urine to establish if there is a significant difference between robotic and open~     surgery. The study will also investigate the potential benefits of minimally invasive surgery~     on the surgical trauma associated with open surgery by assessing the surgical stress response~     between groups of kidney transplant patients receiving either open or minimally invasive~     kidney transplants and by comparing wound healing with patients undergoing donor nephrectomy.~   "
18659|NCT03322696|"~     Patients with cirrhosis of viral etiology (HCV/HBV); Patients with cirrhosis of any other~     etiology (alcohol, idiopatic, autoimmune). Planned Number of cirrhotic subjects 200 patients~     Inclusion Criteria Subjects (18 yr old) with liver cirrhosis of any etiology, Exclusion~     Criteria All patients should not have hepatocellular carcinoma or other malignant tumors,~     they should not be treated with anticoagulant / antiplatelet agents, not affected by PVT~     already diagnosed and not suffering from congenital coagulation disorders (haemophilia A / B,~     von disease Willebrand, another congenital deficiency of coagulation factors) or severe~     thrombocytopenia (<30,000 Plt / μL). Subject has participated in another clinical study~     within 30 days prior to study enrollment or is scheduled to participate in another clinical~     study on cirrhosis Primary Objective To describe the prospective modification of ADAMTS-13~     level and other coagulation variables (e.g. FVIII, VWF:Ag/VWF:act) in cirrhotic patients~     during 18 months from the enrolment and to verify their predictive role as biomarker of~     development of portal vein thrombosis (PVT) Secondary Objectives To describe prospectively~     the modification of ADAMTS-13 level as a function of the etiology of cirrhosis Statistical~     analysis The total duration of the study will be of 12 months. The sample size of 200~     subjects will be selected as a feasible number of patients to be recruited in a period of six~     months. The patients will be consecutively enrolled and followed for 18 months. As a result,~     in a follow up period of 18 months about 20-25 cases of PVT are expected. Continuous~     variables will be expressed as means ± standard deviations. In addition to descriptive~     statistics (location parameters), univariate analysis will be performed on each parameter and~     development of PVT during the follow up period. In previous observational studies both 1) a~     reduced PV flow [prospectively] and 2) a reduction of ADAMTS-13 are significantly associated~     with PVT. These associations will be investigated prospectively and analyzed simultaneously~     by a multivariate analysis and ROC curve to establish the sensitivity and specificity of~     these parameters as predictors of PVT development. Analyses will be performed using available~     data~   "
18660|NCT03322683|"~     This study aim to investigate the effects of physium therapy for improving pressure pain~     thresholds (PPTs), range of motion and pain in patients with mechanical neck pain (NP).~   "
18661|NCT03322670|"~     Statement of the problem:~      Overprescription of antibiotics raises important public health issues because of the~     emergence of multiresistant bacteria by selection pressure. The results of the observational~     prospective study entitled CAPA on the description of 886 suspected cases of acute~     community-acquired pneumonia (CAP) treated in general practices in France confirm that,~     whatever the etiologic hypothesis and the results of the chest X-ray, these patients~     routinely receive antibiotics. Therefore, it is important to be able to distinguish cases of~     pneumococcal CAP in which early antibiotic treatment is justified from those cases for which~     another strategy could be considered.~      Primary objective:~      To identify the clinical, biological and radiological characteristics of patients with~     pneumococcal CAP amongst all patients with CAP radiologically confirmed, in general practice~     in France.~      Design :~      Prospective cross-sectional descriptive study.~      Inclusion criteria. Adults older than 18 showing clinical signs suggestive of CAP (at least~     one sign of infection and at least one pulmonary sign) and able to realize chest X ray within~     6 hours after prescription.~      Patient follow-up procedures. Patients will be treated by standard of care according to~     French recommendations. After observing clinical signs suggestive of CAP, the physician~     prescribes a chest X-ray. Then, protocol-specific examinations (blood sample, oropharyngeal~     sample for multiplex polymerase chain reaction (PCR), sputum sample testing (induced~     expectoration if possible), urinary sample) will be performed on all out patients. Patients~     will be contacted again on day 28 to increase diagnostic certainty. For patients with~     clinical signs of CAP and hospitalized, the investigator will ask their consent to retrieve~     the hospital report, on or before day 28 and to be contacted on day 90.~   "
18662|NCT03322657|"~     The aim of this study is to evaluate whether the use of Sugammadex for reversing the~     neuromuscular blocking effects of rocuronium during neurointerventional procedures can speed~     recovery of neuromuscular function. Half of participates will receive Neostigmine with~     glycopyrrolate, while the other half will receive Sugammadex.~   "
18663|NCT03322644|"~     Pain is the cardinal symptom of acute recurrent and chronic pancreatitis, and available~     medical treatments have limited efficacy. Pain self-management programs equip patients to~     minimize the impact of chronic painful conditions on activity, health, and psychosocial~     functioning. The purpose of the current study is to pilot the use of Internet-delivered pain~     self-management course in adults with chronic and acute recurrent pancreatitis to generate~     preliminary feasibility and acceptability data to inform design of a subsequent large~     randomized controlled trial.~   "
18664|NCT03322631|"~     The purposes of this study are to determine:~        -  The safety of LY3298176 and any side effects that might be associated with it.~        -  How much LY3298176 gets into the bloodstream and how long it takes the body to remove~          it.~        -  How LY3298176 affects the levels of blood sugar.~      This study includes eight weekly doses of LY3298176 or placebo given as subcutaneous (SC)~     injections just under the skin. The study will last about 16 weeks (total), including~     screening and follow-up. This study is for research purposes only and is not intended to~     treat any medical conditions.~   "
18665|NCT03322618|"~     the main objectives are~        1. to study the pathophysiological role of KIR3DL2 in axSpA and its relationship with Th17~          immunity in HLA-B27 + and HLA-B27- patients and~        2. to assess the effect on the pro-inflammatory immune response of a cytotoxic monoclonal~          antibody IPH4102 (anti-KIR3DL2) in these patients.~      The study will be carried out on blood samples from 24 patients with axSpA, 12 HLA-B27 + and~     12 HLA-B27-, without any drug injection nor direct therapeutic benefit for the participating~     patients and 12 healthy controls.~   "
18666|NCT03322605|"~     Patients who undergo salpingo-oophorectomy +/- hysterectomy (laparoscopic or laparotomy) for~     benign indications, early cervical cancer or low-risk endometrial cancer will be included.~     Patients with other pelvic malignancies, previous bilateral salpingectomy or bilateral~     oophorectomy and excessive adhesions will be excluded. Laparoscopy and laparotomy groups will~     be compared in terms of fibril tissue remnants on the ovarian surface.~   "
18725|NCT03321838|"~     This pilot study is designed specifically to determine the short-term effect of OBVAT on~     intermittent exotropia in terms of 4 key areas (Standardizing reported outcomes of surgery~     for intermittent exotropia): control score, alignment, near stereoacuity and quality of life~     score. Result of this pilot study will be used to determine whether a full-scale RCT should~     be conducted to evaluate the short and long term effectiveness of OBVAT.~   "
18667|NCT03322592|"~     Rationale: Rapid on-Site Evaluation (ROSE) of cytologic specimens acquired with EUS-guided~     fine needle aspiration (EUS-FNA) represents the most accurate available technique to reach a~     definitive diagnosis in patients with pancreatic solid masses. Cytologic interpretation,~     however, requires a high degree of expertise rarely found outside high volume centers and~     ROSE is not available in many countries. This has created a barrier to the widespread~     dissemination of EUS in the community and throughout the world, because the lack of cytologic~     expertise has resulted in a low diagnostic accuracy and, therefore, in a limited perceived~     utility of EUS. A device that is able to: (i) acquire histologic core biopsy samples usually~     easier to be interpreted; (ii) be used by most of the endosonographers and not only by the~     experts; (iii) have a performance at least not inferior to ROSE, will represent a major~     breakthrough in the field of EUS tissue acquisition. The availability of such needles will~     determine a shift from cytology to histology that will overcome some of the limitations of~     cytology and ROSE, thus strongly contributing to the diffusion of EUS throughout the world~     and in the community.~      Objectives: To compare the performance and the diagnostic accuracy of EUS-guided fine needle~     biopsy (EUS-FNB) coupled with ROSE with that of EUS-FNB alone using an FNB needle.~      Study design: International randomized multicenter trial. Study population: Patients ≥18~     years old, referred for EUS-guided tissue sampling of a solid pancreatic mass.~      Intervention: EUS-guided tissue acquisition by means of either EUS-FNB with ROSE or EUS-FNB~     alone, using one of the following FNB needles: Procore 20-gauge, SharkCore 22-gauge or~     Acquire 22-gauge.~      Main study parameters/endpoints: The main endpoint is the diagnostic accuracy, measured~     against the gold standard diagnosis that will be surgical resection specimen or in~     non-operated patients the results of other diagnostic work-up (other tissue sampling~     techniques and imaging studies) or the clinical course of the disease. Secondary endpoints~     include: i) safety; ii) presence of tissue core; iii) feasibility to perform additional~     immunohistochemical/molecular biology analyses; iv) time of the sampling procedure.~   "
18668|NCT03322579|"~     Balloon dilatation Eustachian tuboplasty has recently become a promising procedure for the~     treatment of refractory dilatory dysfunction of the Eustachian tube.~      Eustachian tube (ET) comprises an osseous intratemporal portion and a cartilaginous~     nasopharyngeal portion. It functions in pressure equalization, middle ear protection and~     clearance. Eustachian tube function can be adversely affected by viral and bacterial~     infections, adenoid disease, craniofacial anomalies, neoplasm, genetic predisposition,~     sinonasal disease and gastroesophageal reflux, leading to Eustachian tube dysfunction.~     Eustachian tuboplasty by balloon dilation involves the recanalization of the cartilaginous~     portion of the ET via the nasopharynx with a balloon catheter. This catheter is inflated to~     multiple atmospheres of pressure for a short amount of time and then removed.~      The surgical technique, the optimal balloon diameter, pressure or duration of inflation are~     variable in the literature.~      Even though the current data shows promising results and a potential benefit of this~     procedure, further evaluation is still needed in order to establish a higher level of~     evidence of efficacy and safety.~   "
18669|NCT03322566|"~     The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus~     epacadostat with platinum-based chemotherapy versus pembrolizumab plus platinum-based~     chemotherapy plus placebo as first-line therapy in participants with metastatic non-small~     cell lung cancer (NSCLC).~   "
18670|NCT03322553|"~     Gastro-esophageal reflux disease (GERD) is a common gastrointestinal disorder with a~     significant proportion of patients becoming dependent on proton pump inhibitor (PPI) therapy.~     Long term use of PPI therapy can be associated with side effects such as osteoporosis, small~     intestinal bacterial overgrowth and renal failure. Moreover, some of the patients might be~     reluctant to take PPIs for long duration and prefer surgery over pharmacotherapy. Endoscopic~     plication (GERD-X) is an alternative and less invasive procedure compared to laparoscopic~     fundoplication for the treatment of GERD. In endoscopic plication, transmural sutures are~     applied at the gastro-esophageal (GE) junction thereby reconstructing the gastric cardia and~     accentuating the valvular mechanism to prevent reflux. Only few trials have evaluated the~     efficacy of endoscopic plication technique and reported encouraging results. In this study we~     aim to evaluate the efficacy of a similar endoscopic technique but with application of two~     transmural sutures in randomized controlled method.~   "
18671|NCT03322540|"~     The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus~     epacadostat compared to pembrolizumab plus placebo as first-line treatment in participants~     with metastatic non-small cell lung cancer (NSCLC) expressing high levels of programmed cell~     death ligand 1 (PD-L1).~   "
18672|NCT03322527|"~     Hemorrhoids surgery technics evolved during the past 20 years. Recently a new one using laser~     have been developped. It aims at reducing the blood flow towards hemorroïdal plexuses by~     photocoagulating with a fiber laser the terminal branches of the superior rectal artery.~      The aim is to evaluate the efficacy of this technic and note the post surgery pain and events~   "
18673|NCT03322514|"~     The current protocol aims to investigate the impact of the propionate ester in conjugation~     with restricted diet on appetite and weight loss.~   "
18674|NCT03322501|"~     The purpose of the study is to determine if an Ask, Advise, Connect (AAC) intervention model~     benefits tobacco control outcomes for pediatric primary care providers (pPCP's) and their~     young patients.~   "
18675|NCT03322488|"~     In this pilot study a new surgical treatment approach for perianal fistulae, called~     Fistulodesis, is performed. The study aims to assess effectiveness, safety and tolerability~     of the Fistulodesis procedure. The investigators are aiming to include 20 patients with~     Crohn's disease and 20 patients without underlying Crohn's disease. It is an open label study~     with an anticipated duration from January 2017 to January 2020.~   "
18676|NCT03322475|"~     A total of at least 20 healthy subjects at a single site, with at least two facial sub-areas~     with visible wrinkles with pigmentation and/or acne scars who wish to improve their skin~     appearance will be enrolled into the study. subjects will receive 3 treatments and return to~     follow-up visits at 1, 3, and 6 months following the last treatment.~   "
18677|NCT03322462|"~     This protocol is designed to serve as a pre-screening study for subjects who are potentially~     eligible for Alzheimer's Disease (AD) therapeutic trials that require tau imaging for~     inclusion by means of a flortaucipir F18 Positron Emission Tomography (PET) scan.~   "
18678|NCT03322449|"~     Nutrients and chemicals in food are able to regulate expression of genetic elements.~     Gene-nutrient interaction in response to unhealthy diets can increase an individual's risk,~     shifting the individual from health toward the development of chronic disease. The~     apolipoprotein A2 (APOA2) gene may either put individuals at risk for or protect from obesity~     in the presence of certain fats in food. The main purpose of this four-week study is to~     examine diet induced gene-nutrient interaction, with a focus on gut health, gut microbiota~     and inflammation in individuals who have either the CC or the TT form within a specific~     variant of the APOA2 Gene. The (2) one-week study diets, one plant based and the other animal~     based are separated by a (1) week return to your regular habitual without probiotic or~     prebiotic food products.~   "
18681|NCT03322410|"~     Bioimpedance is recently known to be a reliable, reproducible and validated technic allowing~     determination of hydratation status in patients with chronic kidney disease treated with~     peritoneal dialysis (PD). Overhydratation attested by bioimpedance is strongly associated~     with cardio-vascular morbidity and mortality in patients with PD. Overhydratation might~     concern more than half of patients at PD initiation, though the underlying mechanism remains~     unknown.~      High peritoneal permeability (HPP) might concern about a third of patients starting a PD,~     although only a few datas are published on this condition. HPP at initiation of PD is~     associated with a decrease in both technical and patient survival and might be responsible of~     ultrafiltration failure. The underlying mechanisms of HPP at initiation of PD also remains~     unknown.~      To our knowledge, the correlation between hydratation status and peritoneal permeability at~     initiation of peritoneal dialysis remains unknown. Moreover, there is no datas concerning the~     cinetic evolution of peritoneal permeability; demographic or biologic factors associated with~     HPP in days and months following PD start.~      The aim of the present study is to correlate hydratation status (attested by bioimpedance)~     and peritoneal permeability at early start of peritoneal dialysis. Thus, we investigated~     early cinetic of peritoneal permeability at different time point during the first year of~     peritoneal dialysis and we analyzed the demographical and biological factors associated with~     HPP and overhydratation during this period.~      This study is a prospective, multicentric cohort study. Fourty patients recruited in a two~     years' period in five centers of nephrology will be included. Hydratation status will be~     determined with Fluid Overload measurement by bioimpedance technic thanks to BCM system~     (Fresenius Medical Care®). Peritoneal permeability will be determined by modified Peritoneal~     Equilibration Test with complete drainage at sixty minutes. Datas will prospectively be~     collected, including: weight, blood pressure, diuretic posology, diuresis, PD modality,~     dialysate prescribed.~   "
18682|NCT03322397|"~     Adolescents will complete a 4-week intervention, during which they will either complete a~     kind act for others, complete a kind act for themselves, or report their daily activities~     three days per week. Psychological and physiological measures will be indexed before and~     after the intervention.~   "
18683|NCT03322384|"~     Checkpoint blockade immunotherapy has revolutionized the management of a variety of advanced~     malignancies. Monoclonal antibodies targeting the PD-1 / PD-L1 interaction have received FDA~     approvals for non-small cell lung cancer, melanoma, Merkel cell carcinoma, renal cell~     carcinoma, hepatocellular, squamous cell carcinoma of the head and neck, microsatellite~     instability high colorectal carcinoma, urothelial carcinoma, and classical Hodgkin's~     lymphoma. Despite the promising evidence for deep and durable responses with these agents,~     the majority of patients either fail to respond or develop resistance to treatment. Thus,~     there is interested in developing alternative immunotherapeutic strategies. The investigators~     hypothesize that a novel immunotherapeutic combination of radiotherapy (RT) with~     intralesional CpG and indolamine-2,3-dioxygenase blockade may offer significant clinical~     benefit to patients and proposing a microtrial testing this combination for~     advanced/refractory solid tumors and lymphoma.~   "
18684|NCT03322371|"~     The purpose of this study is to compare a 2-lead frontal electroencephalogram recording to a~     formal polysomnography (PSG) in detecting sleep vs. wake and depth of sleep in both healthy~     and ICU patients.~   "
18685|NCT03322358|"~     A large body of medical research has shown that sleep deprivation adversely affects outcomes~     ranging from cognitive function to pain sensitivity and cardiovascular function. Much of this~     evidence comes from sleep labs in the developed world, where sleep can be carefully~     manipulated, and short-run physiological and cognitive outcomes precisely measured. In~     contrast, there is much less knowledge about how sleep deprivation affects the health of~     individuals in the developing world, coming from a lack of studies outside the lab and over~     longer periods. This project aims to fill this gap. The investigators will implement a~     randomized controlled trial (RCT) with 450 low-income adults in Chennai, India, providing the~     first objective measurement of sleep in a developing country. The investigators will also~     evaluate scalable interventions to improve the sleep of poor adults, such as providing home~     sleep-aid devices and a comfortable space for a 30-minute afternoon nap at the participants'~     work site. Finally, the study aims to assess the impact of improved sleep on health, with a~     primary focus on cardiovascular health and cognitive outcomes.~   "
18686|NCT03322345|"~     Patients that have undergone a Fontan procedure (surgical correction for single ventricle~     congenital heart disease) may develop a complication known as protein-losing enteropathy~     (PLE). Some studies suggest PLE is primarily caused by impaired lymph flow. Use of continuous~     dopamine infusion can improve PLE. Evidence suggests the effect of dopamine may be through~     its effect on lymphatic function. This observational study looks at markers of lymph flow and~     PLE symptoms after treatment using dopamine and other standard therapies during disease~     exacerbations.~   "
18687|NCT03322332|"~     The aim of the study is to investigate whether the expression and production of adipokines~     secreted by the epicardial adipose tissue correlate with the degree of coronary~     atherosclerosis.~   "
18688|NCT03322319|"~     The frequency of cardiac amyloidosis among patients presenting with a so-called left~     ventricular hypertrophy remains unknown. This problem is especially relevant in the~     Caribbean's, where an amyloidosis-prone mutation of transthyretin gene might be frequent.~   "
18689|NCT03322306|"~     Hereditary neurological disorders are relatively common in paediatric neurological practice,~     but it has considerable overlap with adult neurological disorders. It is a group of of~     genetic diseases, most of which with a Mendelian inheritance affecting neurological system.~     Pathogenic mechanisms of these diseases are not fully understood. There is currently no~     effective therapy for most of these diseases. Disease-specific and patient- specific iPS~     cells would provide useful source of cells in culture modeling in these diseases.~      In this study, disease-specific iPS cell lines repositories from hereditary neurological~     disease patients will be established. The cell lines will be registered and make them~     available to other investigators.~   "
18690|NCT03322293|"~     This is a randomized, single-blind controlled trial with parallel group design to determine~     whether daylight photodynamic therapy (PDT) affords a reduction in treatment symptoms of~     pain, burning, and pruritus as measured by 1) symptom level during the treatment period and~     2) pain at the end of treatment exposure.~   "
18726|NCT03321825|"~     Evaluation of the sensitivity of the Merz Cheeks Fullness Assessment Scale (MCFAS) and the~     clinical relevance of aesthetically pleasing outcomes by detecting changes in cheek~     appearance after Belotero® Volume Lidocaine injection.~      The safety objectives include the identification and description of adverse events (AEs),~     adverse device effects (ADEs), serious adverse events (SAEs), serious adverse device effects~     (SADEs), anticipated serious adverse device effects (ASADEs) and unanticipated adverse device~     effects (UADEs) during the course of the study. Additionally, common treatment site responses~     (CTRs) will be assessed.~   "
18727|NCT03321812|"~     The trial evaluates the clinical efficacy and safety of decalcification bone scaffold for~     cartilage lesions of the knee. Half of participants will receive decalcification bone~     scaffold combined with microfracture, while the other will only receive microfracture as a~     control group.~   "
18691|NCT03322280|"~     Portal vein tumour thrombus (PVTT) is a common complication of hepatocellular carcinoma~     (HCC). PVTT has a profound adverse effect on prognosis, with a very short median survival~     time (2-4 months). The presence of PVTT also limits treatment options, such as liver~     transplantation and curative resection. Although the Barcelona Clinic Liver Cancer group~     recommended sorafenib as a standard therapy for advanced-stage HCC, the optimal treatment for~     HCC with PVTT remains largely controversial.~      Some studies have reported a survival benefit in patients with PVTT who underwent~     transarterial chemoembolization (TACE), even in patients with main portal vein (MPV) tumor~     thrombus. Iodine-125 brachytherapy had also showed promising efficacy as a new method for~     unresectable HCC with PVTT. Results of our previous study indicated that TACE combined with~     Iodine-125 seeds implantation might be a good choice for selected patients with PVTT. Thus,~     we conduct this study to farther evaluate the effect of TACE combined with Iodine-125 seeds~     implantation for HCC with PVTT.~      270 patients with HCC and PVTT will be included and randomized to two group: group 1,~     patients received TACE combined with Iodine-125 seeds implantation; group 2, patients~     received TACE alone. TACE and Iodine-125 seeds implantation will be performed with a~     standardized procedure. Iodine-125 seeds implantation into PVTT (guided by CT) will be~     conducted 7 days after TACE.~      All patients revisit our institutions for follow-up examinations including contrast enhanced~     CT/MRI and laboratory tests every 4-6 weeks after the first treatment. Patients who have a~     tumor response rating of complete response will be required to revisit 3 months interval. At~     each visit, TACE or Iodine-125 seeds implantation is repeated if the following criteria are~     reached: 1) images indicating viable intrahepatic tumor tissue or PVTT; 2) Child-Pugh class A~     or B, and no contraindication to TACE and Iodine-125 seeds implantation.~      The primary end point of this study is overall survival. The secondary end points are time to~     tumor progression, disease control rate, duration of portal patency and adverse events. All~     adverse events are graded in accordance with Common Toxicity Criteria Adverse Events Version~     (CTCAE) 4.03.~   "
18692|NCT03322267|"~     In this study, participants with histologically diagnosed locally advanced esophageal~     squamous cell carcinoma who have received preoperative cisplatin-based chemoradiotherapy~     followed by surgery harbouring high risk of tumor recurrence will receive adjuvant~     cisplatin-based chemoradiotherapy followed by pembrolizumab. The primary study hypothesis is~     that adjuvant pembrolizumab will improve the 1-year recurrence-free survival rate compared to~     historical control.~   "
18693|NCT03322254|"~     Reviewing providers' current standard operating procedure on Respiratory Pathogen testing~   "
18694|NCT03322241|"~     Healthcare Decisions Post-Testing On Risk Reducing, and Preventative Strategies Utilizing~     Wellness Lab Tests~   "
18695|NCT03322228|"~     This is a study to assess the feasibility and acceptability of implementing a music therapy~     intervention for caregivers of hospitalized patients who are referred to inpatient hospice.~   "
18696|NCT03322215|"~     This is a randomized, 2-arm, open-label, multicenter, international phase II trial. A total~     of 196 patients will be included.~      The study will include patients with metastatic Hormone Receptor positive / Human Epidermal~     Growth Factor Receptor (HER2) negative breast cancer with progressive disease after endocrine~     treatment.~      Patients will be randomized (1:1) between two treatment arms: A. palbociclib + fulvestrant~     and b. capecitabine.~   "
18697|NCT03322202|"~     The purpose of this study is to test the efficacy of a Motivational Interviewing intervention~     on therapy participation as performed by physical and occupational therapists in an inpatient~     setting with patients with spinal cord injuries.~   "
18698|NCT03322189|"~     Current providers' standard operating procedures on pharmacogenomic testing patients~   "
18699|NCT03322176|"~     Increase surveillance for LYNCH Syndrome~   "
18700|NCT03322163|"~     Little is known about maternal iodine nutrition before conception and its relation with the~     child's cognitive function. Using samples and data from the Southampton Women's Survey,~     iodine measurements from urine collected before the mothers became pregnant will be related~     to cognitive function measures in the children at age 6-7 years.~   "
18701|NCT03322150|"~     Patients undergoing lower extremity surgery with spinal anesthesia are often sedated to~     reduce patient discomfort due to large noises during surgery and also to reduce anxiety. Most~     commonly used sedatives include propofol and midazolam, but these agents are known to often~     cause hypotension or respiratory depression. Dexmedetomidine is a selective alpha 2~     adrenergic drug, which acts as a sedative and also has analgesia effects. In contrast to~     propofol or midazolam, dexmedetomidine rarely causes respiratory depression, and therefore is~     often used in critically ill patients in the ICU and also in patients undergoing simple~     procedures. Hemodynamically, dexmedetomidine evokes a biphasic blood pressure response with a~     short hypertensive phase and subsequent hypotension. Bradycardia is also observed in many~     patients, which may lead to more serious outcomes when progressing to sinus pause or shock.~     Therefore, drugs to prevent bradycardia during dexmedetomidine infusion may help patients~     maintain a more stable hemodynamic state. The present study aims to compare the ability of~     atropine and glycopyrrolate to prevent bradycardia during dexmedetomidine infusion in~     patients undergoing lower extremity orthopedic surgery with spinal anesthesia.~   "
18702|NCT03322137|"~     To characterize the efficacy, safety and tolerability of SNA-120 at 2 doses versus placebo~     when administered topically for the treatment of pruritus associated with psoriasis vulgaris~     (PV) and PV itself.~   "
18703|NCT03322124|"~     The objective of the study is to demonstrate the superiority of 0.1% octenidine mouthwash~     (Octenidin Mundspüllösung, OML) to placebo (PLAC) in the inhibition of plaque formation. The~     study will consist of a 14-day screening period and a 5-day treatment period.~   "
18704|NCT03322111|"~     With this study the investigator wants measure the individual cyclofusion competence from~     healthy subjects and patients suffering from Strabismus with a only binocularly visible~     threedimensional Landolt-C stimulus. For this the participant has to look at a 3-D monitor~     with shutter glasses. The participant is sitting in 2 meter distance in front of the monitor.~     On the monitor appears the Landolt-C stimulus as a dynamic Random-Dot Stimulus. As long as~     the participant can fuse the stimulus he will be able to see the Landolt C-ring~     threedimensional. The participant is then ask to tell in which direction the notch of the~     Landolt-C ring points out. Once a critical degree of cyclotorsion is reached the participant~     will no longer be able to see the Landolt C ring and the individual cyclofusion competence is~     reached.~   "
18728|NCT03321799|"~     Wound complications and surgical site infections following revision total joint arthroplasty~     result in significant morbidity and cost. To the investigators knowledge, no prospective,~     randomized controlled trials have examined the rate of wound complications, infection, and~     reoperation following revision total hip arthroplasty when treated with negative pressure~     wound therapy (NPWT) versus sterile dressings. The investigators hypothesize that the rate of~     wound complications, infections, and subsequent procedures in patients undergoing revision~     THA treatment will demonstrate a statistically and clinically relevant decrease when using~     NPWT versus sterile dressing.~   "
18705|NCT03322098|"~     Patients undergoing total knee arthroplasty with spinal anesthesia are often sedated to~     reduce patient discomfort due to large noises during surgery and also to reduce anxiety. Most~     commonly used sedatives include propofol and midazolam, but these agents often cause~     hypotension or respiratory depression, especially in elderly patients. Dexmedetomidine is a~     selective alpha 2 adrenergic drug, which acts as a sedative and also has analgesia effects.~     In contrast to propofol or midazolam, dexmedetomidine rarely causes respiratory depression,~     and therefore is often used in critically ill patients in the ICU and also in patients~     undergoing simple procedures. Hemodynamically, dexmedetomidine evokes a biphasic blood~     pressure response with a short hypertensive phase and subsequent hypotension. Bradycardia is~     also observed in many patients, which may lead to more serious outcomes in elderly patients~     who often have multiple comorbidities. Therefore, drugs to prevent bradycardia during~     dexmedetomidine infusion may help patients maintain a more stable hemodynamic state. The~     present study aims to compare the ability of atropine and glycopyrrolate to prevent~     bradycardia during dexmedetomidine infusion in elderly patients undergoing knee surgery with~     spinal anesthesia.~   "
18706|NCT03322085|"~     This study explored the influence of radiofrequency catheter ablation and cryoballoon~     ablation on atrial electrical remodeling in patients with atrial fibrillation,the~     relationship between atrial electrical remodeling and structural remodeling,and which~     indicators are associated with atrial recurrence after catheter ablation.~   "
18707|NCT03322072|"~     This is a single arm seamless phase I/II prospective cohort study. Patients with early stage~     Non-Small Cell Lung Cancer (T1-T2N0M0) or those with a single pulmonary metastasis of a known~     malignancy (either following radical treatment or systemic therapy) will be offered~     participation in this study. Participants will have three tumor locator beacons placed with a~     flexible bronchoscope in the small bronchial airways in proximity (<3cm) from their lung~     tumors. These tumor locator beacons will provide real-time positional data and will allow for~     smaller treatment volumes of Stereotactic Ablative Radiosurgery (SABR) and also allow for a~     specialized form of treatment delivery known as respiratory gated SABR. This is expected to~     result in higher precision radiotheapy delivery with less radiotherapy dose to healthy~     tissues which are in close proximity to the lung tumours.~   "
18708|NCT03322059|"~     The investigators propose to examine whether linking daily activity with charity-based~     incentives motivates cancer survivors to initiate and maintain physical activity. Linking~     daily physical activity goals with a cancer specific charity incentive may provide a uniquely~     salient motivator that promotes increased physical activity among cancer survivors. The~     investigators will examine whether using activity monitors in combination with charitable~     incentives leads to greater increases in physical activity compared to activity monitors~     alone. Target participants includes cancer survivors who are not already active. Physical~     activity (e.g., steps per day, time in moderate-intensity activity) will be examined at~     baseline and following a 12-week intervention period using an activPAL accelerometer. After~     the baseline assessment, both groups will receive a fitbit monitor and informational material~     designed to increase physical activity. Participants in the fitbit+charity group will have~     donations made in their name to a cancer charity if they meet daily step goals. Physical~     activity levels will be monitored using the fitbit device for 6-weeks following the formal~     intervention period.~   "
18709|NCT03322046|"~     The purpose of this protocol is to observe whether providing the first responder population~     with a multi-tiered therapeutic lifestyle modification program, including regular blood~     testing, diet and telephonic lifestyle coaching, daily food journaling using web-based tools~     and smartphone apps can lead to positive changes in behavior, resulting in improvements in~     blood based markers of risk of cardiovascular disease (CVD) as well as improvements in weight~     and waist circumference.~   "
18710|NCT03322033|"~     The purpose of this early feasibility study is to investigate the outcome of selected~     patients with ascending thoracic aortic pathologies including type A aortic dissection, who~     are suitable for endovascular repair with the Medtronic Valiant PS-IDE Stent Graft System~     with the Captivia Delivery System (or the Valiant PS-IDE Stent Graft).~   "
18711|NCT03322020|"~     For the treatment for intermediate- and high-risk prostate cancer, Cyberknife boost will be~     used after 4 weeks of intensity modulated radiotherapy to pelvis. The boost doses are 18 Gy~     and 21 Gy in 3 fractions, respectively. The investigators plan to evaluate the toxicity of~     two dose groups and decide the appropriate dose for Cyberknife boost. Also, PSA control will~     be evaluated.~   "
18712|NCT03322007|"~     BACKGROUND: Pain is the predominant and most feared symptom of pancreas cancer, and is often~     incompletely relieved. Scrambler Therapy is a new way of treating pain by providing~     non-pain information to confuse the nervous system and reset the damaged nerve pathways. It~     has been useful in treating many types of pain, but has not been adequately tested in the~     pain associated with pancreas cancer.~      OBJECTIVE: The goal of this study is to evaluate the effect of Scrambler Therapy on typical~     abdominal pain associated with pancreas cancer.~      HYPOTHESIS: We hypothesize that pain scores from day 0 (pre) to day 28 (post) will be reduced~     by at least 33%, e.g. from 6/10 to 4/10.~      METHODS: 20 patients, with expected data from 18 due to drop out of 2, will be treated with~     Scrambler Therapy using the standard methods of 45 minute sessions for 10 treatments.~      OUTCOMES: We will record data using the Brief Pain Inventory, and EORTC Quality of Life~     Questionnaire-Pancreas 26 to see if we obtain at least a 33% reduction in pain. This will~     inform future randomized trials of Scrambler Therapy versus traditional methods such a celiac~     plexus blocks.~   "
18713|NCT03321994|"~     The purpose of this study was to compare the safety and efficacy of CT-guided needle guidance~     using stereotaxic unit, navigation versus conventional biopsy technique for the patients~     scheduled to undergo percutaneous pulmonary nodule biopsy.~   "
18729|NCT03321786|"~     The goal of this study is to determine whether survivors of Legionnaires' disease suffer~     smell loss. A quantitative olfactory test will be performed by the participants. Such testing~     will require approximately 20-30 minutes of the participant's time. The participants will~     take the University of Pennsylvania Smell Identification Test (UPSIT), a scratch-and-sniff~     test to assess their ability to identify odors in a forced- choice format. Volunteers will~     also complete a questionnaire asking personal history, demographic questions, and medical~     history.~   "
18730|NCT03321773|"~     Reverse hybrid therapy achieves a higher eradication rate than bismuth (triple therapy plus~     bismuth) remains unanswered~   "
18714|NCT03321981|"~     A Phase 2, open-label, multicenter international study will be performed to evaluate the~     efficacy of MCLA-128-based combinations. Three combination treatments will be evaluated, two~     in Cohort 1 and one in Cohort 2.~      MCLA-128 is given in combinations in two metastatic breast cancer (MBC) populations,~     HER2-positive/amplified (Cohort 1) and Estrogen Receptor-positive/low HER2 expression~     (Cohort2).~      Two combinations treatments will be evaluated in Cohort 1, the doublet and triplet. Initially~     MCLA-128 is given in combination with trastuzumab in the doublet. After the safety of the~     doublet has been assessed in 4-6 patients, MCLA-128 is given in combination with trastuzumab~     and vinorelbine in the triplet, in parallel to the efficacy expansion of the doublet.~      The doublet and triplet combinations are both evaluated in two steps with an initial safety~     run-in followed by a cohort efficacy expansion. In total up to 40 patients evaluable for~     efficacy are included in both the doublet and triplet.~      In Cohort 2 MCLA-128 is administered in combination with the same previous endocrine therapy~     on which progressive disease is radiologically documented. A total of up to 40 patients~     evaluable for efficacy are included in the Cohort 2.~   "
18715|NCT03321968|"~     This Phase 3 study is intended to assess the clinical lot-to-lot consistency in manufacturing~     by evaluating and comparing the immunogenicity of three consecutively manufactured lots of~     the Quadrivalent Virus-Like Particles (VLP) Influenza Vaccine, during the 2016-2017 influenza~     season, in healthy adults 18-49 years of age. A single dose of one of three consecutive lots~     of Quadrivalent VLP Influenza Vaccine (30 µg/strain) will be administered to 1,200 subjects.~   "
18716|NCT03321955|"~     The primary objective of this study is to prospectively examine outcomes in 12 patients using~     ziconotide Intrathecal Drug Therapy(IDT) as first-line monotherapy with the use of an~     algorithm of slow titration for dosing. The use of Prialt has demonstrated fewer and less~     serious associated adverse effects as compared to IDT morphine, especially when titrated~     slowly. We will use an average Numerical Rating Scale as our primary outcome and the Oswestry~     Disability Index(ODI), Beck Depression Inventory (BDI), Pain Catastrophizing Scale (PCS),~     Clinical Global Impression of Change Scale including binary satisfaction measures(CGIC),~     Lawton-Brody Instrumental Activities of Daily Living(IADL) and Short Form-36 as secondary~     outcome measures.~   "
18717|NCT03321942|"~     To investigate the biological characteristics of adipose tissue-derived mesenchymal stem~     cells(AMSCs) and its treatment effects on chronic renal failure.~   "
18718|NCT03321929|"~     This is a non-randomized, open-label, multi-site study to evaluate the safety and efficacy of~     an intraoperative imaging system, the LUM Imaging System (LUM015 imaging agent in conjunction~     with the LUM imaging device), in identifying residual cancer in the tumor bed of female~     breast cancer patients. During the study, study physicians and clinical staff will complete~     hands-on training in anticipation of the upcoming pivotal study. Site-specific or~     user-specific issues related to the use of the device will be identified and addressed.~     Additionally, the data collected in the study will be used to continue training the tumor~     detection algorithm of the device.~      In this study, patients will be injected with LUM015 prior to surgery. The study physicians~     will perform lumpectomy procedures according to his or her institution's standard of care~     practice. After the main specimen removal is completed, the study physician will use the LUM~     Imaging Device to image the tumor bed. Therapeutic shaves will be removed based on the~     recommendation of the LUM Imaging System. Patients will be followed until their first~     standard of care post-operative follow-up visit.~   "
18719|NCT03321916|"~     This is a two armed Single Masked Pilot Study enrolling participants with Macular~     Telangiectasia Type 2 who will be randomized to undergo either a subthreshold photothermal~     treatment or a sham procedure to one eye. The participants will be followed for one year with~     visits at 1 month, 3 months, 6 months and 12 months post-treatment (laser or sham). Due to~     the small number of participants enrolled in this study the data will be analyzed by~     descriptive statistics and exploratory figures. Summary statistics will be produced for study~     and fellow eyes.~   "
18720|NCT03321903|"~     It has been well established that malignant tumors tend to have low levels of oxygen and that~     tumors with very low levels of oxygen are more resistant to radiotherapy and other~     treatments, such as chemotherapy and immunotherapy. Previous attempts to improve response to~     therapy by increasing the oxygen level of tissues have had disappointing results and~     collectively have not led to changing clinical practice. Without a method to measure oxygen~     levels in tumors or the ability to monitor over time whether tumors are responding to methods~     to increase oxygen during therapy, clinician's reluctance to use oxygen therapy in usual~     practice is not surprising.~      The hypothesis underlying this research is that repeated measurements of tissue oxygen levels~     can be used to optimize cancer therapy, including combined therapy, and to minimize normal~     tissue side effects or complications. Because studies have found that tumors vary both in~     their initial levels of oxygen and exhibit changing patterns during growth and treatment, we~     propose to monitor oxygen levels in tumors and their responsiveness to hyperoxygenation~     procedures. Such knowledge about oxygen levels in tumor tissues and their responsiveness to~     hyper-oxygenation could potentially be used to select subjects for particular types of~     treatment, or otherwise to adjust routine care for patients known to have hypoxic but~     unresponsive tumors in order to improve their outcomes.~      The overall objectives of this study are to establish the clinical feasibility and efficacy~     of using in vivo electron paramagnetic resonance (EPR) oximetry—a technique related to~     magnetic resonance imaging (MRI)—to obtain direct and repeated measurements of clinically~     useful information about tumor tissue oxygenation in specific groups of subjects with the~     same types of tumors, and to establish the clinical feasibility and efficacy of using~     inhalation of enriched oxygen to gain additional clinically useful information about~     responsiveness of tumors to hyper-oxygenation. Two devices are used: a paramagnetic charcoal~     suspension (Carlo Erba India ink) and in vivo EPR oximetry to assess oxygen levels. The ink~     is injected and becomes permanent in the tissue at the site of injection unless removed;~     thereafter, the in vivo oximetry measurements are noninvasive and can be repeated~     indefinitely.~   "
18721|NCT03321890|"~     To observe the efficacy and safety of Chidamide combined with prednisone, cyclophosphamide,~     etoposide and methotrexate in relapsed or refractory PTCL.~   "
18722|NCT03321877|"~     An 8 week 'real-life' inhaled corticosteroid (ICS) dose reduction study in patients with~     severe asthma without evidence of bronchial hyperactivity.~   "
18723|NCT03321864|"~     Through this study the investigators seek to build up a repository of prostate~     ultrasonography videos and prostate MRI scans to enable research into novel anatomical~     registration techniques. These data will facilitate the development of improved technology~     that enables targeting of tumours seen on MRI using free-hand biopsy techniques, without the~     need for a gantry or overlaid perineal grid.~   "
18724|NCT03321851|"~     This trial seeks to demonstrate clinical accuracy and safety of the integrated V-Sensor when~     used by the general, healthy adult population interested in measuring their vital signs~     outside of the clinical setting.~   "
18754|NCT03321461|"~     Investigators aimed to determine the validity of the novel tumor targeted fluorescent~     TMTP1-ICG to increased accuracy of colposcopy-directed biopsy.~   "
18755|NCT03321448|"~     investigators aimed to determine the validity of our novel tumor targeted fluorescent~     TMTP1-ICG to increased accuracy of laparoscopic SLN mapping~   "
18731|NCT03321760|"~     Conventionally fractionated radiation therapy given over 6-7 weeks alone, sequentially, or~     concurrent with chemotherapy have produced poor outcomes in Stage II NSCLC in most series.~     Stereotactic ablative radiotherapy (SABR) has been shown to be very effective and is now~     standard of care for Stage 1 disease. There has been initially reluctance to utilize SABR for~     central lung tumors because of published reports that showed an excess of toxicity when SABR~     was utilized; however, newer data with less intense treatment regimens suggest safety in~     treatment of central lung disease. The safety and efficacy of SABR in treating hilar nodes or~     N1 disease currently is not known fully and will be evaluated in this study.~   "
18732|NCT03321747|"~     The purpose of this study is to test whether 5 fraction stereotactic ablative body radiation~     (SABR) is safe and improves local control for early state squamous cell carcinoma of the~     lung. While three fraction SABR is effective for the treatment of early stage non small cell~     lung carcinoma (NSCLC) of all histologies, it is not safe for many patients. While four and~     five fraction SABR is safe, recently published data and our institutional data suggests that~     local control for early stage squamous cell carcinoma of the lung using the current four or~     five fraction SABR is suboptimal.~   "
18733|NCT03321734|"~     The proposal will address the critical question: is persisting intermittent hypoxia (IH) in~     preterm infants associated with biochemical, structural, or functional injury, and is this~     injury attenuated with extended caffeine treatment? This study will look at the effects of~     caffeine on IH in 220 preterm infants born at ≤30 wks gestation. Infants will be enrolled~     when the clinical care team is planning to stop routine caffeine within the next 5 days.~     Infants will be started on continuous pulse oximeter recording of O2 saturation and heart~     rate at enrollment, and will be randomized (110/group) to extended caffeine treatment or~     placebo beginning the next day after stopping routine caffeine treatment. Randomized infants~     will receive 10 mg/kg/day of caffeine or equal volume placebo prior to 36 wks PMA, and 10~     mg/kg BID (twice-a-day) (TDD 20 mg/kg)(or equivalent volume) beginning at 36 wks PMA. Study~     drug will be continued until 42 weeks PMA. Pulse oximeter recordings will continue 1~     additional week. Two caffeine levels will be obtained, the 1st at 37 wks, and the 2nd at home~     at 40-41 weeks PMA. Inflammatory biomarkers will be measured at study enrollment and again at~     37-38 weeks PMA. Quantitative MRI/MRS will be obtained at study enrollment and study~     completion.~   "
18734|NCT03321721|"~     Hand and feet lacerations are common in children with repair often requiring conscious~     sedation and needle sticks for repair. Growing evidence in adults reveal that many of these~     small lacerations do quite well cosmetically without intervention. This randomized controlled~     trial will evaluated the cosmetic outcome at 4 months in two groups of children with hand or~     feet lacerations <2 cm comparing suturing vs conservative wound management.~   "
18735|NCT03321708|"~     Hypothesis:~      COPD patients with frequent exacerbations have different pulmonary and systemic immune~     response than COPD patients without frequent exacerbations and this is related to their~     microbiome.~   "
18736|NCT03321695|"~     This is a study of the safety and effectiveness of atezolizumab in participants with~     metastatic non-small cell lung cancer (NSCLC) who have disease progression during or~     following platinum-containing chemotherapy. Participants also will have progressed on an~     appropriate approved targeted therapy if their tumor has epidermal growth factor receptor~     (EGFR) or anaplastic lymphoma kinase (ALK) gene abnormalities treated in common clinical~     practice settings in Argentina.~   "
18737|NCT03321682|"~     Heart Failure is a progressive disorder that begins after an insult to the heart muscle~     resulting in the loss of functional cardiomyocytes, or even compromising the ability of the~     myocardium to contract and/or relax normally. A common finding in heart failure is exercise~     intolerance that generates a vicious cycle, in which the individual starts to limit his~     activities even further due to progressive fatigue. Studies demonstrate that regular physical~     exercise can increase the aerobic capacity of these individuals, delay the anaerobic~     threshold, and reestablish the sympathovagal balance. Paradoxically, many of these patients~     assume an even more sedentary lifestyle, which leads to a greater physical limitation and the~     progression of symptoms. Patients with HF present a 30% reduction in their ability to perform~     their daily life activities when compared to healthy individuals, and this has also been~     attributed to reduced muscle mass, as well as lower aerobic capacity. In this sense, strength~     training increases the torque and muscular endurance, capacity and functional independence,~     as well as the quality of life, reducing the morbidity of individuals with and without~     cardiovascular disease, with a lower overload to the cardiorespiratory system. It is known,~     however, that daily life activities require a combination of resistance and muscle strength.~     Aerobic training does not improve muscle strength, just as traditional strength training does~     not ideally represent the movements performed during daily life activities, since it does not~     include exercises on unstable surfaces and exercises on different axes. Functional training~     emerges as a simple and low cost alternative for the treatment of patients with heart~     failure. This method consists of integrated movements of the body, in several axes, involving~     joint acceleration and deceleration, stabilization, strength and neuromuscular efficiency. It~     aims to improve the functional capacity of the individual using exercises that relate to~     their specific physical activity, transferring their gains effectively to their daily lives.~     The aim of the present study is to evaluate the effects of functional training on~     cardiopulmonary capacity and quality of life in patients with heart failure, comparing it to~     strength training.~   "
18738|NCT03321669|"~     Capsule endoscopy studies are used for the diagnosis of small bowel mucosal lesions. Since~     capsule endoscopy depends on the small intestinal peristaltism, the food intake - especially~     the amount of fat ingested - after the ingestion of the capsule may have an impact on the~     capsule endoscopy transit time and thus its diagnostic yield. As a consequence, an open-label~     randomized pilot study was designed to determine wether increased dietary intake of fat after~     the ingestion of the capsule endoscopy may influence small intestinal transit time and thus~     the diagnosis of small bowel lesions.~   "
18739|NCT03321656|"~     This will be a single center, prospective, open-label, randomized, controlled trial comparing~     Envarsus XR® to twice-daily tacrolimus. The targeted population will be patients with end~     stage renal disease listed for primary solitary kidney transplant. Transplant Surgery is not~     part of the study.~   "
18740|NCT03321643|"~     This pilot phase I trial studies the side effects of atezolizumab, gemcitabine, oxaliplatin,~     and rituximab and to see how well they work in treating patients with transformed diffuse~     large B-cell lymphoma that has come back or does not respond to treatment. Monoclonal~     antibodies, such as atezolizumab, may interfere with the ability of cancer cells to grow and~     spread. Drugs used in chemotherapy, such as gemcitabine, oxaliplatin, and rituximab, work in~     different ways to stop the growth of cancer cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Giving atezolizumab, gemcitabine,~     oxaliplatin, and rituximab may work better in treating patients with transformed diffuse~     large B-cell lymphoma.~   "
18801|NCT03320850|"~     This study will evaluate the efficacy and safety of BOTOX® intravesical instillation in~     participants with overactive bladder and urinary incontinence.~   "
18741|NCT03321630|"~     This is an open label, single arm phase II study, to determine the overall response rate for~     the combination of lenvatinib and pemrolizumab in patients with metastatic gastroesophageal~     cancer who have progressed on first or subsequent line therapies. Given the significant cross~     talk between angiogenesis and the immune response, combined therapy with lenvatinib and~     pemrolizumab in advanced gastroesophageal cancer patient will provide improved outcomes~     compared to standard treatment with currently approved agents.~   "
18742|NCT03321617|"~     Participants will be administered several doses of POMA (low and high doses) over 14 days to~     individuals at clinical high risk for developing psychosis and use MRI brain imaging to~     determine whether these doses of POMA are affecting glutamate levels.~   "
18743|NCT03321604|"~     In this study, Investigators will conduct a prospective cohort study of dialysis patients by~     collecting research-quality information on patient characteristics, comorbid diseases and~     laboratory markers used in routine practice, as well as novel biochemical markers and genetic~     data. Investigators will utilize data from the cohort to test the independent relationship~     between biochemical and genetic markers and Fabry disease and other rare diseases.~   "
18744|NCT03321591|"~     It is estimated that over 200 million children under 5 years of age in developing countries~     are not attaining their developmental potential (e.g., neurobehavioral development) primarily~     because of poverty and associated health, nutritional deficiencies, and unstimulating home~     environment. Child's Neurobehavioral development consists of several interdependent domains~     of sensory-motor, cognitive-language, and social-emotional function. Experiences in the first~     few years of life are of particular importance because vital development occurs during this~     period. Early under nutrition, iron-deficiency, environmental toxins, stress, and poor~     stimulation and social interaction can affect brain structure and function. Stunting,~     inadequate cognitive stimulation, iodine deficiency, and iron deficiency anemia are~     identified as key risk factors, where the need for cognitive intervention is urgent, that~     prevent millions of young children from fulfilling their developmental potential and~     neurobehavioral development. It is clear that underprivileged children require not only good~     health, nutrition, and wealth but also supportive and caring environments and cognitive~     stimulation for their optimum neurobehavioral development as in the case of Bangladesh.~     Cognitive function and self-esteem of mothers is crucial for having the optimum outcome from~     intervention. However, little is known regarding the importance of mother's cognitive ability~     influencing different domains of her children's neurobehavioral development. This is how, the~     investigators plan to measure the maternal cognitive function and to assess the~     neurobehavioral development of underprivileged children. The investigators will enroll 200~     mothers and children as a sample of the present study. Bayley Scales of Infant and Toddler~     Development will be used along with other interview scales.~   "
18745|NCT03321578|"~     This service evaulation aims to investigate how common diarrhoea is in hospital patients on~     medical, surgical and elderly care wards, what it is due to and how it is managed.~   "
18746|NCT03321565|"~     Patient records from Johns Hopkins Weight Management Center historical files~   "
18747|NCT03321552|"~     The objective of this post-market study is to evaluate the safety and effectiveness of the~     LimFlow System in creating a below-the-knee arterio-venous fistula for venous arterialization~     in subjects with critical limb ischemia.~   "
18748|NCT03321539|"~     To see the effect if a combination of concurrent chemoradiotherapy followed by different~     adjuvant chemotherapy in treating patients with N2-3 nasopharyngeal carcinoma(NPC).~   "
18749|NCT03321526|"~     The purpose of this study is to assess the efficacy of flexibly dosed JNJ-42847922 (20~     milligram [mg] or 40 mg) compared to flexibly dosed quetiapine extended-release (XR) (150 mg~     or 300 mg) as adjunctive therapy to an antidepressant drug in delaying time to all-cause~     discontinuation of study drug over a 6-months (24 weeks) treatment period, in participants~     with major depressive disorder (MDD) who have had an inadequate response to current~     antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or~     serotonin-norepinephrine reuptake inhibitor (SNRI).~   "
18750|NCT03321513|"~     Both aflibercept and bevacizumab have been shown to improve vision in eyes with DME. In eyes~     with DME and at least moderate vision loss, both aflibercept and bevacizumab were also shown~     to be successful in many eyes. However, aflibercept was shown to be more effective at~     improving vision, on average, at 1 year and at 2 years. Due to the large cost difference~     between the two drugs, many clinicians and patients are choosing to initiate treatment with~     bevacizumab and then switch to aflibercept depending on the eye's response to bevacizumab~     treatment. However, there is no scientific evidence that this treatment strategy is as~     effective at improving vision as initiating treatment with aflibercept. Patients and~     clinicians do not know if this approach ultimately has deleterious effects on visual acuity.~     If starting with aflibercept is not better than starting with bevacizumab and switching to~     aflibercept if needed, the potential cost savings to future patients and the health care~     system would be substantial. However, if starting with aflibercept is better, then patients,~     clinicians, and health care providers can make informed decisions for how to best treat~     patients with DME and at least moderate vision loss.~      Study Objectives To compare the efficacy of intravitreous aflibercept with intravitreous~     bevacizumab + deferred aflibercept if needed in eyes with CI DME and moderate vision loss~   "
18751|NCT03321500|"~     Resilient liners were introduced in the1950s and have been used since then as a gold standard~     material to increase the tolerance, retention and comfort of complete dentures. Due to~     drawbacks of conventional resilient liners, their longevity is questionable and they require~     replacement which is time consuming and costly for the dentist and patient respectively.~     Versacryl is a biocompatible intraoral thermo-elastic material. So versatile, it can be used~     to improve esthetics, retention and comfort for the patient. It softens with heat and when it~     is inserted to patient's mouth, it cools to body temperature providing desired rigidity. This~     process can be repeated many times to ensuring the comfort for the patient. Versacryl has a~     reported predictable long term performance, durable bonding to acrylic denture bases, high~     fatigue endurance, excellent wear characteristics and solvent resistance with almost no free~     monomer in the processed material .~      The investigators' trial is done in order to improve the longevity and oral health related~     quality of life of soft liners in comparison to silicone-based soft liners.~   "
18752|NCT03321487|"~     The purpose of this study is to evaluate the safety, tolerability, and feasibility of~     Blood-Brain Barrier (BBB) opening using transcranial MRI-guided focused ultrasound in~     conjunction with an intravenous ultrasound contrast agent in patients with Amyotrophic~     Lateral Sclerosis (ALS).~   "
18753|NCT03321474|"~     Patient with discolored anterior teeth and need conservative restoration treated with all~     ceramic esthetic laminate veneers. The Patient will be satisfied with restoration mimic the~     surrounding natural teeth, but conventional preparation shows approximately 60% of veneer~     failure in form of color change and nearly 67% Fractures of laminate veneers so the modified~     gull wing preparation is a significant factor affecting the final esthetic especially in~     discolored teeth and improve fracture resistance of the restoration.~   "
18756|NCT03321435|"~     Placenta previa is a placenta that implants at lower uterine segment, it occurs in about~     0.3-0.5% of pregnancies at term. It is a significant risk for development of maternal~     morbidity, as well as maternal mortality secondary to maternal hemorrhage . Also, this~     abnormal placenta has a negative concern about fetal well being due to prematurity and~     perinatal mortality, in addition to its undesirable effect on fetal growth. Several factors~     may be behind of the effect of placenta previa on fetal growth. Firstly, the blood supply to~     the lower uterine segment is less than at the upper segment apparently resulting in less~     feto-placental blood perfusion . Secondly, recurrent bleeding attacks from placental previa~     may affect fetal oxygenation and fetal growth.~      In spite of above evidences; many studies in literature denied the relation between placenta~     previa and fetal growth and concluded that the association between low birth weight and~     placenta previa is mainly due to preterm delivery and to a lesser extent with fetal growth~     restriction. However; the major drawback of all these studies is lacking of reporting the~     effect of placenta previa of feto-maternal blood flow representing in studying of Doppler~     blood flow in both uterine and umbilical artery in those patients. The uterine artery blood~     flow is usually affected by the presence of placenta previa and placenta accreta which~     reflected on feto-placental blood flow. So the uterine artery Doppler velocimetry is a useful~     tool for predicting placenta accreta .~      So in the light of above evidences; we aimed, in the current study, not only to investigate~     the effect on placenta previa on fetal weight but also to walk around the effect of placenta~     previa on the uterine and umbilical arteries blood flow in trial to explore this conflicting~     issue. To our knowledge, no previous trial had studied this interesting subject before.~   "
18757|NCT03321422|"~     The incidence of Legg-Calvé-Perthes disease (LCPD) ranges from 0.4/100,000 to 29.0/100,000~     children <15 years of age. There is significant variability in incidence within racial groups~     and is frequently higher in lower socioeconomic classes. The typical age at presentation~     ranges from 4 to 8 years (average 6.5 years).The optimal treatment goal in Legg-Calvé-Perthes~     disease (LCPD) is to obtain a spherical femoral head with good congruency to prevent or delay~     the onset of osteoarthritis after skeletal maturity. There is agreement that patients younger~     than 5years with a good remodeling capacity have a particularly excellent prognosis,~     irrespective of treatment.~   "
18758|NCT03321409|"~     The Patient Health Questionnaire-15 (PHQ-15) is a frequently used questionnaire to assess~     somatic symptom burden. The Somatic Symptom Scale China (SSS-Ch) was recently developed as a~     comprehensive self-report instrument in assessing somatic symptom burden, but its assessment~     value has not yet been widely tested in a nationwide. The study aims to investigate the~     reliability of the SSS-Ch, to validate discriminate validity and factorial validity, and to~     investigate its utility in patients with suspected coronary artery disease (CAD) based on~     multi-centers inpatients.~   "
18759|NCT03321396|"~     The aim of the investigators' study is to evaluate the mucosa-elevating capacity and clinical~     safety of Sodium Alginate (SA) mixed with Calcium Lactate in assisting Endoscopic Submucosal~     Dissection/Endoscopic Mucosal Resection.~   "
18760|NCT03321383|"~     Previous studies reported health related quality of life impairment in functional dyspepsia~     patients. Anxiety, depression, disease severity, age, and employment status associated with~     HRQOL in functional dyspepsia patients. However, data about HRQOL in Asian population was~     limited.This study aimed to evaluate factors associated with health related quality of life~     in patients with functional dyspepsia.~   "
18761|NCT03321370|"~     Preliminary evaluation of electrodes placed on the brain for recording brain activity and~     novel algorithms to determine cortical spreading depolarization foci of origination following~     severe traumatic brain injury requiring neurosurgical intervention.~   "
18762|NCT03321357|"~     The five-repetition sit-to-stand test has been validated and is used primarily in pulmonary~     medicine and cardiology, and has recently been shown to be a useful tool for the objective~     assessment of functional impairment in patients with degenerative diseases of the lumbar~     spine.~      The goal of this study is to assess the possibility of supervised and unsupervised~     at-home-assessment. Validation of at-home-assessment would allow the 5R-STS to be easily used~     as a follow-up tool in clinical trials, for example.~   "
18763|NCT03321344|"~     Single arm pilot study to evaluate the safety and initial feasibility of the Neurolyser XR, a~     new portable high intensity focused ultrasound device, for noninvasive thermal ablation of~     medial nerve branches of painful lumbar facet joint/s~   "
18764|NCT03321331|"~     WaznApp study is a 12-week randomized controlled trial aimed to evaluate the feasibility and~     preliminary efficacy of a self-directed behavioral weight-loss intervention targeting~     employees of an academic institution, using two popular consumer mobile applications for~     weight loss. The hypothesis is that individuals assigned to the app that provides interactive~     feedback and proactively motivates engagement in healthy behaviors (eating healthily and~     being more active) will be significantly better than those who receive the comparison~     condition (a simple calorie tracking app).~   "
18765|NCT03321318|"~     An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the~     pharmacokinetics characteristics of AK-R215~   "
18766|NCT03321305|"~     Due to the increased focus on education and changing lifestyle, college students are~     particularly susceptible to poor overall health and wellness due to inadequate sleep and poor~     dietary choices. This is particularly important because the behavioral choices college~     students make may affect their risk of chronic disease. This study will research these topics~     via an online survey, in person visit and stool sample.~   "
18767|NCT03321292|"~     Intrauterine growth restriction is an important problem in neonatal care. Intrauterine growth~     restriction (IUGR) is defined as a fetal weight below the 10th percentile for gestational~     age. One of the main causes of IUGR is placental insufficiency.~      Nitric oxide(NO) increases placental blood flow. So,it might be useful to improve IUGR~     pregnancy outcome .~   "
18768|NCT03321279|"~     This study aims to assess the effectiveness of a social incentive-based gamification~     intervention to increase physical activity in the 3 months after hospital discharge.~   "
18769|NCT03321266|"~     The study is a retrospective review of the use of the Biodesign® Fistula Plug (C-FPS-[X]). A~     total of 73 patients will be enrolled who have had a fistula plug placed to treat anorectal~     fistulas and will therefore be eligible for statistical analysis.~   "
18770|NCT03321253|"~     It has been hypothesized that potential effects of laser Nd: YAG laser posterior capsulotomy~     may affect macular pigment as well as choroidal thickness, macular thickness and anterior~     chamber parameters, so it was aimed to investigate possible effects of Nd: YAG laser~     posterior capsulotomy on macular pigment optical density, choroidal thickness, macular~     thickness and anterior chamber parameters in cases with posterior capsule opacification in~     this study.~   "
21926|NCT03280030|"~     This study will evaluate the efficacy and safety of midostaurin in combination with~     daunorubicin/cytarabine induction, high dose cytarabine consolidation and midostaurin single~     agent continuation therapy in newly diagnosed patients with FLT3-mutated acute myeloid~     leukemia (AML).~   "
18771|NCT03321240|"~     Focal Cortical Dysplasias (FCDs) are neurodevelopmental disorders that represent a major~     cause of early onset drug-resistant epilepsies with cognitive and behavioral impairments,~     carrying a lifelong perspective of disability and reduced quality of life. Despite a major~     medical and socio-economic burden, rationale therapeutic strategies are still under debate.~     Surgical removal of the epileptogenic brain area (Epileptogenic Zone) is the most successful~     treatment, yet it fails to control FCD-associated seizures in as much as 40% of cases.~     Precise definition and complete resection of the Epileptogenic Zone are the main determinants~     of outcome. In current practice of French centers, up to 80% FCD-patients require an~     intracranial EEG (icEEG) recording to accurately define the epileptogenic zone. However, the~     indications for icEEG in MRI-visible FCD remain empirical and are essentially based on expert~     opinion.~   "
18772|NCT03321227|"~     The purpose of the present study is to determine the effects of eggs and egg components on~     cognitive performance and appetite in children aged 9-14 years, as well as to identify the~     underlying physiological mechanisms in this relationship.~   "
18773|NCT03321214|"~     The current treatment for celiac disease is a strict 100% gluten free diet. Little is known~     about the best way to promote adherence to such a strict diet and how to maximize quality of~     life at the same time.~      This pilot will look at the utility of a new innovation to promote gluten free diet adherence~     - a portable gluten sensor device. Participants will be 30 teenagers and adults with celiac~     disease recruited from the Celiac Disease Center at Columbia University in New York City.~     Before and after the intervention, participants will be asked about their adherence to a~     gluten free diet, quality of life, symptoms, and feelings of anxiety, and depression. This~     pilot data will help to inform interventions that the investigators hope to test in a larger~     NIH-funded trial to better understand the best ways to promote adherence and quality of life~     in celiac patients.~   "
18774|NCT03321201|"~     Pterygium is a noncancerous growth of the conjunctival tissue over the cornea. It is a~     progressive disease that may lead to visual impairment in advanced stages, as well as~     restriction of ocular motility, chronic inflammation and cosmetic concerns. Surgical removal~     is the treatment of choice, but recurrence of pterygium is a frequent problem. In this~     randomized controlled cauterization will be compared with ﬁbrin glue for conjunctival~     autografting in primary pterygium surgery.~   "
18775|NCT03321188|"~     This study will evaluate the use of Heated Intraperitoneal Chemotherapy (HIPEC) for primary~     treatment of ovarian cancer at the time of surgical debulking, to assess if intravenous (IV)~     chemotherapy can be started within 42 days of HIPEC and cytoreduction. All patients will~     receive cytoreductive surgery followed by a one-time closed HIPEC with cisplatin at 41-43~     degrees Celsius for 90 minutes in the operating room. This is followed by 6 cycles of~     intravenous carboplatin and paclitaxel on an outpatient basis.~   "
18776|NCT03321175|"~     to evaluate the effect of subcutaneous irrigation on wound complications~   "
18777|NCT03321162|"~     16 implant placement by surgical guide using double scan protocol versus triple scan protocol~     to Evaluate angular and linear deviation of virtual implants and actual implant position in~     completely edentulous patients according to scanning protocol C1(double scan technique) and~     C2 (triple scan technique) .~   "
18778|NCT03321149|"~     The current study aimed to develop and assess an easy-to-use, highly accessible mobile and~     web-based application intervention to reduce sedentary behavior and increase physical~     activity in the hope of reducing the side effects of treatment and improving quality of life~     for the 13,000 or more prostate cancer survivors who are prescribed ADT each year in Canada.~     The study was conducted in two phases, where Phase one was focused on finding out about the~     attitudes and perceptions of sedentary behavior and the use of mobile applications among~     prostate cancer survivors using semi-structured interviews. Together with professional~     experts and a group of men who were diagnosed with prostate cancer, we developed RiseForTx -~     an application that is used on a smartphone or tablet to reduce time spent in, and to change~     patterns of, sedentary behaviour each day (Phase two). Part of the intervention was also~     focused on increasing daily steps to improve physical activity. We tested the intervention to~     examine (i) how the application works, (ii) if prostate cancer survivors like it and use it;~     and (iii) if sedentary behaviour and physical activity can reduce the impact of the side~     effects for treatment and improve quality of life among men on ADT.~   "
18779|NCT03321136|"~     Serotonin receptors, especially the 5HT2A receptor, are thought to be involved in the effects~     of various recreationally used psychedelic substances such as LSD. LSD potently stimulates~     the 5-HT2A receptor but also 5-HT2B/C, 5-HT1 and dopaminergic receptors. LSD induces acute~     transient alterations in waking consciousness including visual perceptual alterations,~     audio-visual synesthesia, derealization and depersonalization. LSD has therefore been used as~     experimental tool (psychotomimetic) in modern psychiatric research to study psychotic-like~     states and model psychosis in healthy subjects [1-5]. However, the dose-effects of 5-HT2A~     receptor stimulation by LSD has not yet been studied. Additionally, there is still very~     limited data to what extent the 5HT2A receptor contributes to LSD's effects and its role in~     the mediation of the full response to LSD at a high dose is unclear. A recent experimental~     human study showed the 5-HT2A receptor antagonist ketanserin fully blocked the subjective~     effects of a moderate dose of 100 µg of LSD [6]. But, whether the effects of a high 200 µg~     oral dose of LSD can be blocked by the selective pharmacological 5-HT2A antagonist ketanserin~     remains to be tested to confirm the critical role of the 5-HT2A receptor in more pronounced~     alterations of consciousness and perception. The present study therefore explores the role~     the 5-HT2A receptor in LSD-induced altered states of consciousness using escalating doses of~     LSD and the 5-HT2A receptor blocker ketanserin administered before a high dose of LSD.~   "
18802|NCT03320837|"~     The aim of this trial is to verify - based on metabolomics and other anthropometric~     parameters - whether exclusive nutrition of infant formula enriched with synbiotics~     (probiotics B.lactis and prebiotics FOS), Long-Chain Polyunsaturated Fatty Acids (AA, DHA)~     and nucleotides, is comparable to breast milk and to mixed nutrition including breast milk~     together with the enriched infant formula.~   "
18881|NCT03319797|"~     Prospective, Multicenter, Single-arm Phase III Clinical Trial to Evaluate the Efficacy and~     Safety of NOVOCART® Inject plus in the Treatment of Cartilage Defects of the Knee. The~     primary objective of this trial is to demonstrate efficacy of NOVOCART® Inject plus for the~     treatment of cartilage defects of the knee based on the Knee injury and Osteoarthritis~     Outcome Score (KOOS) responder rate 24 month after transplantation.~   "
18780|NCT03321123|"~     Precursor-B acute lymphoblastic leukemia (ALL) is the most common cancer in childhood.~     Despite major advances in ALL therapy, 20% of children and 40-50% of adults fail state-of-the~     art first-line treatment. But there is a strong need for alternative treatments to cure~     chemotherapy-refractory and relapsed B cell malignancies in pediatric patients. Relapsed and~     refractory B cell malignancies remain a therapeutic challenge, as these diseases are~     characterized by adverse survival. These cancers share a cell origin from the B-cell lineage~     and consequent surface expression of B-lineage markers such as CD19 and CD22. Chimeric~     antigen receptor (CAR) engineered T cell therapy has recently emerged as a new modality to~     target B cell malignancies. CARs couple a single-chain Fv (scFv) domain directed against a~     B-lineage-specific antigen to T-cell activating intracellular signaling domains. CAR~     gene-modified T cell interaction with target cells occurs in a HLA-independent fashion, so~     that a single vector can be used to treat all patients with cancers that express the target~     antigen. Miltenyi Biotec has established a semi-automated manufacturing process that can be~     made available to academic settings for systematic exploration of CAR strategies in advanced~     clinical studies. Closed-system operation, improved robustness, simplified work flows, and~     reduced labor intensity, while maintaining strict adherence to regulatory guidelines, allows~     for decentralized manufacturing. In the proposed phase II study, the investigator will~     explore autologous 2nd generation CD19 CAR T cell products in patients with relapsed and~     refractory disease incurable with standard therapies.~   "
18781|NCT03321110|"~     The aims of the study are: 1) to compare the differences in plasma coenzyme Q10, oxidative~     stress, antioxidant capacity, muscle impairment, fatigue recovery, and inflammation and~     exercise performances among three type of athletes (i.e., swimming, soccer, and taekwondo~     players) and healthy non-athletes; 2) to investigate the relationship between plasma coenzyme~     Q10, oxidative stress, antioxidant capacity, muscle impairment, fatigue recovery, and~     inflammation and exercise performances; 3) to explore the influence on plasma coenzyme Q10,~     oxidative stress, antioxidant capacity, muscle impairment, fatigue recovery, and inflammation~     and exercise performances for three type of athletes, respectively, Week 0, Week 6, and Week~     12 various doses of coenzyme Q10 intervention (150 mg/day and 300 mg/day).~   "
18782|NCT03321097|"~     The purpose of this project is to examine and compare the motor learning process, immediate~     and long-term effects of combined Botulinum toxin type A (BoNT-A) injection between condensed~     and distributed robot-assisted training (RT) programs in patients with spastic hemiplegic~     stroke. Spasticity, a common impairment after stroke, has a profound impact on activity and~     participation for patients. According to the result of the investigator's ongoing study, the~     investigators found BoNT-A injection combined with robot-assisted training is recommended to~     enhance functional recovery for patients with spastic hemiplegic stroke. However, the optimal~     program as considering the RT frequency is unknown.~      The aims of this study are to determine and compare the motor learning processes and~     immediate and longer-term effects between condensed and distributed programs of RT following~     BoNT-A injection in subjects with spastic hemiplegic stroke .~      To estimate the sample size,the investigators conducted a power analysis based on the~     findings of the previous research. If the investigators take WMFT-quality into account, with~     an overall effect size of 0.72, a power set at 0.80, and a two-sided type I error of 0.05,~     the sample size calculation resulted in 32 participants per group. If the investigators take~     WMFT-time into account, with an overall effect size of 1.66, a power set at 0.80, and a~     two-sided type I error of 0.05, the sample size calculation resulted in 7 participants per~     group. Based on the above results and taking into account the possible 10 % dropout rate, the~     investigators plan to recruit 35 participants for each group resulting in a total sample size~     of 70 patients with stroke.~      At least 70 participants with chronic spastic hemiplegic stroke will be recruited and~     randomly assigned to either condensed or distributed RT groups post BoNT-A injection. Each~     training session included 40 minutes RT, followed by 40-minute functional training. The~     condensed group will receive 4 sessions per week, for 6 weeks, the distributed group 2~     sessions per week, for 12 weeks. Body function and structures outcome measures include~     Fugl-Meyer Assessment, Modified Ashworth Scale, myometer (Myoton-3), actigraph. Activity and~     participation measures include Wolf Motor Function Test, Ten meter walk test, Motor Activity~     Log, Nottingham Extended Activities of Daily Living Scale, and Canadian Occupational~     Performance Measure. In addition, to directly reflect a patient's unique needs and goals,~     Goal Attainment Scaling will be assessed. Evaluators will be blind to group allocation. The~     outcome will be measured at pre-treatment, post-treatment, and 6-week follow-up. The~     investigators will also use the movement time of robot without powered assistance and surface~     EMG to determine the motor learning processes of patients receiving the two practice~     frequencies of RT.~      This comparative efficacy study will be the first to examine and compare the motor learning~     processes and immediate and long-term effects between condensed and distributed RT post BoNT~     injection. The results may provide clinicians with the appropriate methods to scheduling RT~     following BoNT-A injection to improve upper limb functions for patients with hemiplegic~     spasticity stroke. From the socioeconomic perspectives, identify the optimal frequency of~     Robotic therapy post BoNT-A injection may reduce medical resource utilization, expenditures,~     and care-giver burden.~   "
18783|NCT03321084|"~     Introduction: The osteoarthrosis is incurable, one of the most incapacitating disease around~     the world and your prevalence is increasing every year. The main consequences of this disease~     is pain and loss of functionality as a result of biomechanical limitations coming from~     articular inflammation. Among the variability of therapeutic resources, we propose MatPilates~     like a no drug intervention, that probably will contribute for a decrease in the symptoms of~     this disease.~      Objective: It is hypothesized that MatPilates is a method capable of decrease pain and~     increase functionality in elderly woman with osteoarthrosis.~      Methods: This study is a randomized double blind clinical trial, in which the volunteer need~     be in between 60 and 69 years old. Will be formed of two groups: MatPilates Group (MG) and~     Control Group (CG), and the ideal n will be calculated in a pilot study.~   "
18784|NCT03321071|"~     Summer vacation represents a window of vulnerability where dramatic declines in both health~     and academics occur for elementary age children. Currently, there are no summer programs that~     incorporate curriculum addressing both unhealthy weight gains and academic achievement~     simultaneously. This work represents an important step towards addressing important public~     health goals - obesity and learning - through a comprehensive program delivered during a~     timeframe - summer vacation - where substantial and long-lasting negative effects occur.~   "
18785|NCT03321058|"~     Patients using multiple drugs including generics have found different solutions to manage~     their medication. During a Polymedication-Check (medication review type 2a service in~     community pharmacies) additional information about the organisation of patients' medication~     in daily life will be compiled in Swiss community pharmacies. Data will allow to better~     address patients' needs in their medication organisation and comprehension of generics.~   "
18786|NCT03321045|"~     Our goal is to investigate the use of 89Zr-trastuzumab as a HER2 imaging agent to determine~     which patients are likely to respond to targeted HER2 agents as single agent therapy. We are~     proposing to perform a pilot study with goals of demonstrating the feasibility of imaging~     breast cancer patients with 89Zr-trastuzumab-PET/MRI, evaluating the relationship between~     tumor 89Zr-trastuzumab uptake and in vitro positivity of HER2, assessing the relationship~     between 89Zr-trastuzumab uptake and response to HER2 therapy.~   "
18787|NCT03321032|"~     This is an investigator initiated randomized trial, performed under the auspices of the~     Spanish Society of Cardiology.~      It is a multicenter, international, parallel, randomized 1:1 (amphilimus-eluting stents vs~     zotarolimus-eluting stents) clinical trial performed exclusively in patients with diabetes~     mellitus. The study has an all-comers diabetics design.~      The primary-endpoint is target lesion failure at 1-year follow-up (non-inferiority design)~     and the co-primary end-point is target lesion failure at 2-years follow-up~     (superiority-design).~   "
18788|NCT03321019|"~     This study will collect data on various aspects of airway sensation and function, and~     determine how it relates to the development of swallowing and cough dysfunction in~     Parkinson's disease. Participants will be followed over a 3-year period, with once-per-year~     visits to collect the data.~   "
18803|NCT03320811|"~     Celiac disease is an autoimmune disorder characterized by a chronic inflammation of the small~     bowel mucosa, triggered by the ingestion of gluten-containing grains.~      The diagnosis of celiac disease was initially based on duodenal biopsies obtained from upper~     endoscopy. Since 1990, the availability of serological tests has contributed to a different~     perception of the disease. Serological testing is now considered fundamental for celiac~     disease screening, even if duodenal biopsies remain the gold standard. Celiac markers usually~     include anti-TG2 antibodies, anti-endomysium antibodies, anti-gliadin antibodies and~     anti-reticulin antibodies. Recently, several studies showed that deamidated products of~     gliadin may enhance T-cell stimulatory activity and improve the reactivity of anti-gliadin~     antibodies. Thus, detection of anti-deamidated gliadin peptide antibodies has been introduced~     into the wide spectrum of serological tests for celiac disease.~   "
18804|NCT03320798|"~     Bullous pemphigoid affects mainly elderly patients. It is often associated with neurologic~     disorders, which represent a major risk factor of the disease~   "
18789|NCT03321006|"~     Age-related hearing loss (ARHL) is the third most common health condition affecting older~     adults after heart disease and arthritis and is the fifth leading cause of years lived with~     disability worldwide. Many hearing-impaired older adults avoid or withdraw from social~     contexts in which background noise will make it difficult to communicate, resulting in social~     isolation and reduced communication with family and friends.Social isolation and loneliness~     have been linked to numerous adverse physical and mental health outcomes, including dementia,~     depression, and mortality, and they may also lead to declining physical activity and the~     development of the syndrome of frailty. In this project it is hypothesized that untreated~     ARHL represents a distinct route to developing Late-life Depression (LLD) and that~     individuals with comorbid ARHL/LLD are unlikely to respond to treatments (i.e.,~     antidepressant medication) that do not treat the underlying hearing problem. Initial studies~     suggest remediation of hearing loss using hearing aids or cochlear implantation may decrease~     depressive symptoms acutely and over the course of 6 to 12 months follow-up. However, the~     clinical significance of these findings is obscured by lack of rigorous control groups,~     failure to objectively document hearing aid compliance, and enrollment of study populations~     lacking syndromal depression or even a threshold symptom score.~   "
18790|NCT03320993|"~     Postprandial glucose control is a challenging issue in everyday diabetes care. Indeed,~     excessive postprandial glucose excursions are the major contributors to plasma glucose (PG)~     variability in subjects with type 1 diabetes (T1DM). In addition, the poor reproducibility of~     postprandial glucose response is burdensome for patients and healthcare professionals.~      To date, the majority of prandial insulin dosing algorithms for subjects with T1DM considers~     only the carbohydrate (CHO) content of the meal. However, there is evidence (although with a~     certain degree of heterogeneity) that meal composition significantly affects postprandial~     glucose control, contributing to glycemic variability. Moreover, despite the high prevalence~     of alcohol consumption among patients with T1DM (about 30%, similar to that of the general~     population), data regarding its effect on the postprandial period are very limited.~      This project will evaluate the effect of meal composition and alcohol consumption on~     postprandial glucose control in subjects with T1DM under intensive insulin treatment.~   "
18791|NCT03320980|"~     Unsatisfactory immediate outcomes of Associating liver partition and portal vein ligation for~     staged hepatectomy (ALPPS) in surgery of cholangiocarcinoma suggested that patients with~     biliary cancer should not be treated by ALPPS. Short-term results of ALPPS variants with~     reduced surgical trauma on the first stage in patients with cholangiocarcinoma were not yet~     estimated. The objective of the study was estimation of the short-term results of~     split-in-situ resection with radio-frequency ablation (RFA) instead of liver partition on the~     first stage (RALPPS) in patients with hilar (h-CCA) and intrahepatic (i-CCA)~     cholangiocarcinoma compared with portal vein embolization (PVE).~   "
18792|NCT03320967|"~     Blood copeptin will be measured during the routine treatment of neonates, children and~     adolescents on the Intensive Care Unit of the University Children`s Hospital Zurich at~     different time points (admission, 12, 24, 48, 96, 168 hours after admission). These values~     will be primarily analysed for their variability and their association with arterial~     hypotension. Blood samples will be drawn together with otherwise medically indicated blood~     withdrawals to avoid extra harm. Further, copeptin values will be compared to clinical and~     vital parameters, all of them open-label available during clinical routine. Copeptin`s~     predictive value for patients` outcome will be analysed as secondary outcome.~   "
18793|NCT03320954|"~     People with acquired brain injury (ABI) often experience persistent language challenges that~     are subtle in nature and not readily observable to others. These challenges can have~     substantial negative effects on vocational and social endeavors despite their subtlety. Even~     though these challenges are prevalent in the ABI population, limited methods exist for~     quantifying and remediating them. The two purposes of Phase I of this research are to (a)~     explore methods of using event related potential (ERP) recordings to quantify language~     processing differences between people with and without ABI and (b) correlate behavioral~     observations from language tests with ERP findings. The purpose of Phase II is to explore the~     use of game-based, group activities as an intervention for people with ABI who experience~     word-retrieval challenges. The purpose of Phase III is to collect post-intervention data for~     comparison with Phase I data and provide evidence about the effectiveness of the intervention~     program.~   "
18794|NCT03320941|"~     The purpose of the study is to evaluate the efficacy, tolerability and safety of LIK066 to~     support dose selection for Phase 3 development in Japanese adults with obesity disease.~   "
18795|NCT03320928|"~     Predictors for pulmonary mortality was determined in a cohort of 79 patients with acute-GVHD~     of the skin. The acute-GVHD treatment was corticosteroids and photochemotherapy~     (Photosensitization with oral 8-methoxysalen and Ultraviolet light type A) with or without~     concomitant methotrexate.~   "
18796|NCT03320915|"~     Graft-versus-host-disease (GVHD) is common complication of hematopoietic stem cell~     transplantation. Vitamin D deficiency has been shown to be associated with increased risk of~     chronic GVHD in previous clinical studies. The purpose of this research is to investigate the~     effect of vitamin D supplementation in patients undergoing hematopoietic stem cell~     transplantation~   "
18797|NCT03320902|"~     Assessment of the psychological benefit of the proposition by prehospital medical team of a~     sudden death counselling on family members of sudden death victims.~   "
18798|NCT03320889|"~     The goal of this study is to assess patients' attitudes and knowledge of Hepatitis C, analyze~     the variables that may influence patients' knowledge, and educate patients on Hepatitis C.~   "
18799|NCT03320876|"~     This is a Phase 2, multicenter, open-label, single arm, Long Term Extension (LTE) safety,~     tolerability and efficacy study of filgotinib in subjects withmoderately to severely active~     PsA.It is estimated that approximately 105 subjects will be rolled-over after they have~     completed the 16 weeks of double-blind treatment in core study GLPG0634-CL-224.Subjects in~     the LTE study will be treated with filgotinib for a duration of 148 weeks. The LTE study is~     concluded with a follow-up visit approximately 4 weeks after the last intake of study~     treatment. Consequently, each subject will stay in the LTE study for a maximum of 152 weeks.~   "
18800|NCT03320863|"~     Enso is a portable device for the treatment of chronic and acute types of musculoskeletal~     pain. This study is being designed as a double-blinded, sham-controlled randomized clinical~     trial.~   "
18805|NCT03320785|"~     Circulating markers to diagnose complications (sepsis, necrotizing enterocolitis) in preterm~     infants are often inaccurate, partly due to the lack of comprehensive studies with temporal~     evaluation from birth until a disease onset. The investigators plan to collect weekly blood~     samples of preterm infants from birth until 4 weeks of age to comprehensively characterize~     differential protein and epigenetic markers in infants with and without complications~     (sepsis, necrotizing enterocolitis, chorioamnionitis).~   "
18806|NCT03320772|"~     Sentinel lymph node (SLN) mapping is an acceptable surgical strategy determine whether to~     perform radical lymphadenectomy in patients with early-stage cervical cancer. Investigators~     aim to determine the validity of this technique with our novel tumor targeted fluorescent~     TMVP1-ICG to increased accuracy of SLN mapping.~   "
18807|NCT03320759|"~     The investigators have spent the last decade uncovering unique metabolic and functional~     abnormalities in the brains of patients with spinal cord compression. Degenerative spinal~     cord compression represents a unique model of reversible spinal cord injury. In the~     investigator's previous work, they have demonstrated that cortical reorganization and~     recruitment is associated with metabolic changes in the brains of patients recovering from~     spinal cord compression and is correlated with recovery and improved neurological scores.~      The goal of this study is to combine a rigorous platform of clinical care that includes~     preoperative evaluation, surgery, and rehabilitation, with state of the art imaging~     techniques to demonstrate how rehabilitative therapy can increase brain plasticity and~     recovery of neurological function in patients with spinal cord injury. Neurological function~     will be carefully evaluated in two groups of patients, those receiving rehabilitation and~     those not receiving rehabilitation after spine surgery, and will be correlated with the~     results of advanced imaging.~   "
18808|NCT03320746|"~     The purpose of REACT project is to provide cost-effective way to promote physical activity~     and reduce sedentary time among older adults. This is done by examining the efficacy of IT~     based intervention on wake-time physical activity, sedentary time, sleep and other health~     outcomes among recent retirees. REACT study will be the first randomized physical activity~     trial targeted to time window right after retirement.~   "
18809|NCT03320733|"~     Cystic pancreatic lesions are increasingly detected incidentally in imaging studies,~     reportedly in up to 45% of the abdominal Magnetic Resonance (MR) examinations. The majority~     of these lesions have potential to become cancer, therefore requiring surgery or imaging~     follow-up to monitor the development of features indicative of malignant transformation.~     Abdominal MR is the current standard of care for the follow-up of pancreatic cysts (PCs).~     However, MR is expensive and access is limited, In our institution, more than 35 MR studies~     for assessment of PCs were performed each month in 2015, placing a significant burden on the~     health care system that includes contributing to longer MR wait times for other indications.~      The investigators will compare MR to two new computed tomography (CT) techniques - dual~     energy CT (DECT) and Subtraction imaging - with regards to their ability to detect features~     associated with increased risk of malignancy (enhancing septa and mural nodules) in PCs. For~     cases where there is disagreement between these 2 CT techniques and MR, histopathology of the~     surgical specimen or the results of Endoscopic Ultrasound (EUS) will serve as reference~     standard.~      Using DECT or Subtraction instead of MR for the assessment and follow-up of PCs would save~     significant healthcare costs and MR slots, which could be released to other indications and~     to reduce waiting times. Furthermore, if DECT and/or Subtraction imaging end up demonstrating~     to be superior to MR for this purpose, patients with cystic pancreatic lesions could have a~     direct benefit.~   "
18810|NCT03320720|"~     The study's goal is to evaluate whether home treatment is an effective and efficient~     alternative to inpatient care for people with acute mental illness. Patients who meet the~     study's inclusion criteria are randomly assigned to either the condition home treatment or~     inpatient care (treatment-as-usual), during one year. Following two years, the two treatment~     modalities will be analyzed in terms of inpatient days, cost effectiveness, rehospitalization~     rate, severity of symptoms and sociodemographics.~   "
18811|NCT03320707|"~     The purpose of this study is to assess the safety and tolerability of daratumumab following a~     single subcutaneous (SC) administration in healthy participants and to determine whether~     premedication with corticosteroids is required to improve the tolerability of SC~     administration of daratumumab in healthy participants.~   "
18812|NCT03320694|"~     Gestational diabetic mellitus (GDM) patients randomised to metformin or insulin group.Aim was~     to achieve blood sugar levels of Blood sugar fasting (BSF) <5.3 mmol/l and 1 hour post~     meal<7.8mmol/l. Both groups were followed till delivery and outcome studied.~   "
18813|NCT03320681|"~     Effect Mechanism Investigation of a Wearable Electrostimulator for Rapid Alleviation of~     Parkinson's Disease Symptoms~   "
18814|NCT03320668|"~     A non-inferiority controlled clinical trial using randomization for allocation at the level~     of general practice in 21 centers (in 8 Spanish regions), to compare a group Otago exercise~     program (OEP) [delivered by specifically trained instructors and supplemented by prescriptive~     recommendations for home exercising], with an individual OEP [also delivered by specifically~     trained professionals and supplemented by prescriptive recommendations for home exercising],~     with twelve months follow-up to determine the effectiveness of the OEP in terms of prevention~     of falls in a community-dwelling 65- to 80-year-old population.~   "
18815|NCT03320655|"~     Patients with chronic heart failure (CHF) underwent to a hospital-based cardiac~     rehabilitation (CR) program in the Lisbon district Hospitals will be recruited. The~     participants will be randomized into one of the following exercise groups: A) combined~     exercise training with more aerobic training and less strength training (CAT); B) combined~     exercise training with more strength training and less aerobic training (CST). The~     investigators will test two proportions in combined training, CAT and CST. There hasn't been~     any data on the so called combined regimes, which include both aerobic exercise with HIIT and~     ST and the investigators will evaluate the effects of acute and chronic response.~      The research project will contribute to a better understanding in several aspects that are~     unexplained by scientific research.~   "
18816|NCT03320642|"~     The purpose of this study is to assess the impact and safety of itacitinib in combination~     with calcineurin inhibitor (CNI)-based interventions for the prophylaxis of~     graft-versus-host-disease (GVHD).~   "
18818|NCT03320616|"~     The farnesoid X receptor (FXR) regulates hepatitis B virus replication through the bile acids~     pathway. EYP001a is a selective, synthetic FXR agonist under development for the treatment of~     hepatitis B.~      This Phase 1 study is designed primarily to assess Pharmacokinetics (PK) under fed and fasted~     conditions, and to assess the safety, tolerability and Pharmacodynamics (PD) of single oral~     doses of EYP001a in subjects with chronic HBV infection.~   "
18819|NCT03320603|"~     The study is assessing the impact of an expert eCRF on the management of severe bleeding in~     the administration of Prothrombin Complex Concentrate in patients treated with oral~     anticoagulants and adherence to recommendations or experts' consensus~   "
18820|NCT03320590|"~     To date, none study shows the impact of human spermatozoa nuclear alteration on embryonic~     development kinetic with morpho-kinetics tools. In this study, Investigator analyze the~     possible influence of sperm nuclear quality on embryonic development kinetics. Moreover,~     Investigator will evaluate possible new sperm biomarkers and try to better understand the~     pathophysiology of male infertility.~   "
18821|NCT03320577|"~     This study will compare participants who have uncontrolled hypertension and perform a set of~     five breathing exercises (Pranayama breathing) to a control group. The purpose of the study~     is to determine the effect of the breathing exercises on reduction of blood pressure.~   "
18822|NCT03320564|"~     A widely used semi-quantitative parameter to assess tumor status is the standardized uptake~     value (SUV). SUV estimation accuracy can be impacted by many variables. Today there still~     exists a significant amount of variability in PET/CT results in test and re-test studies.~     This variability can be introduced by instrumentation and subject-specific factors.~     Variability reduces image quality and increases the required changes in tumor quantification~     to reflect real tumor response or progression.~      PET/CT scanning process requires that the entire net injected dose of radiolabeled tracer is~     administered intravenously as a bolus. The quality and quantification of a PET/CT image is~     highly dependent on the uptake of radiolabeled tracer. Boellaard et al. have indicated~     infiltrations could potentially underestimate SUV measurements by as much as 50%.~     Infiltrations and obstructions are not uncommon.~      Recent studies using a novel QA/QC tool (LaraTM System) for the radiotracer injection process~     revealed that current means to detect infiltration do not completely identify all~     infiltrations/obstructions. Since infiltrations may not be visible in the standard field of~     view (FOV) and since the impact of a peripheral circulatory obstruction may not be visible~     even if an injection site is in the FOV, it is possible for reading and treating physicians~     to be unaware that a patient's image and quantification has been impacted. Additionally, when~     current means do detect an infiltration, they under-represent the severity because they are~     not capturing that infiltrations often resolve during the uptake period. As a result,~     infiltrations or obstructions may cause SUV inaccuracy and could adversely impact staging and~     tumor assessments.~      The purpose of this study will be to characterize the impact of moderate or greater~     infiltrations on standardized uptake values. Patients experiencing a moderate or greater~     infiltration on a routine clinical PET scan will be invited to return for a repeat scan with~     injection performed by specially trained personnel to reduce the risk of repeat infiltration.~     The two scans will be compared to assess for changes in tumor uptake intensity.~   "
18823|NCT03320551|"~     Nutrition and Education Immersion program sponsored by WholeFoods, Inc. for their employees.~   "
18824|NCT03320538|"~     This trial aims to determine whether Jiangzhong Hou Gu® Mi Xi™ is an effective intervention~     to improve symptoms and indicators in patients with spleen qi deficiency and peptic ulcer~     diseases.~   "
18825|NCT03320525|"~     This is a single center phase 1 trial, which evaluates the pharmacokinetic profile of T-ChOS™~     (food supplement Benecta™) in subjects with advanced solid tumors.~   "
18826|NCT03320512|"~     P3 (Prepared, Protected, emPowered) is an interactive smartphone app for HIV-uninfected YMSM~     and YTW that utilizes social networking and game-based mechanics as well as a comprehensive~     understanding of what constitutes best practices in app development to improve PrEP~     adherence and persistence in PrEP care.~   "
18827|NCT03320499|"~     Organisation and logistic about realisation of vascular doppler ultrasound is something very~     eclectic . Need to shift patient from their bed , long waiting time and the effect on the~     hospital cost.~      That's why vascular yard aim to practise these doppler ultrasound directly in the patients'~     room in the bed.~      And like that evaluate the patient's satisfaction of this kind of coverage.~   "
18828|NCT03320486|"~     The main purpose of this study is to demonstrate that dapaconazole cream 2% (experimental~     drug) is non-inferior to ketoconazole cream 2% (Nizoral® - active comparator) for the~     treatment of dermatological lesions of Tinea pedis, when applied to the skin (topically) once~     daily during 28 days. Additionally, the safety and tolerability aspects will be evaluated in~     a descriptive way, through the observation of the incidence of adverse events.~   "
18829|NCT03320473|"~     A. The primary purpose of the study is to evaluate outcomes of aphakic eyes implanted with~     the IC-8 IOL following cataract removal in prior inlay patients after KAMRA inlay removal.~      B. The secondary purpose of the study is to determine whether there are any changes in~     biometry measurements before and after the inlay removal and how the changes affect the~     calculated IOL power.~   "
18830|NCT03320460|"~     The aim of this study was to compare the efficacy of PBM (660nm) and corticosteroid therapy~     with clobetasol propionate 0.05% in the treatment of OLP. This is a protocol for a~     randomized, controlled, double blind clinical trial. Fourty-four patients will be randomized~     in two experimental groups. Control group will be treated with clobetasol propionate 0.05%~     for 30 consecutive days and with placebo PBM twice a week. The experimental group will be~     treated with placebo gel for 30 consecutive days to mask the treatment and patients will~     receive PBM twice a week during 1 month (laser λ = 660±10 nm; power 100mW; radiant energy~     177J/cm2; 5-s exposure time per point and 0.5J of energy per point. The primary variable~     (pain) and the secondary variables including clinical scores and functional scores as well as~     patient anxiety and depression (The Hospital Anxiety and Depression Scale-HADS), will be~     evaluated at the baseline, once a week during treatment and after 30 and 60 days of follow~     up. Evaluation of clinical resolution will be performed at the end of the treatment (30~     days). Evaluation of recurrence will be performed after 30 and 60 days of follow up. Serum~     and salivary levels of IL-6, IL-10, IL-1β, INF-γ and TNF-α will be evaluated at baseline and~     at the end of treatment (30 days). Quality of life will be evaluated by OHIP-14 questionnaire~     at baseline, at the end of treatment and after 30 and 60 days of follow up. The chi-square~     test, Student's t-test and ANOVA will be used and the level of significance of 5% will be~     considered (p < 0.05).~   "
18831|NCT03320447|"~     Er:YAG ablative fractional laser-assisted methyl aminolevulinate photodynamic therapy~     (AFL-PDT) has shown significantly higher efficacy and a lower recurrence rate at 12 months~     than methyl aminolevulinate photodynamic therapy (MAL-PDT) for treatment of Bowen's disease~     (BD). However, long-term follow up data are not available.~   "
18834|NCT03320408|"~     First aim: PARIS study~      The main aim of the current study is to determine the association between abdominal aortic~     aneurysm (AAA) progression and the evolution of proteases and cytokines levels.To achieve~     this aim, we will prospectively collect blood, aortic tissue, patient data, and imaging data.~     Aortic tissue will only be obtained when patients undergo conventional open repair. The other~     biomaterials will be collected during regular patient follow-up visits, with a maximum~     frequency of once per year.~      Second aim: Pearl AAA biobank~      For future research purposes, a new biobanking infrastructure will be created to collect and~     store additional blood and urine samples in a biobank. This biobank will be embedded within~     the infrastructure of the 'Parelsnoer Institute' (PSI) and will be called Pearl AAA. The~     Pearl AAA will be established in the extension of the PARIS study~   "
18835|NCT03320395|"~     Gastrointestinal angiodysplasia (GIAD, a.k.a. angioectasia, arteriovenous malformations or~     AVM, and vascular ectasia) are mucosal or submucosal dilated blood vessels, usually~     multifocal, and a frequent cause of obscure GI bleeding, especially mid-small bowel~     hemorrhage.~      Endoscopic treatment using argon plasma coagulation (APC) is popular but presents limitations~     as application of the therapy is not uniform, and passing the catheter repetitively through~     the enteroscope may not be possible. Despite endoscopic treatment rebleeding rates are high,~     between 25 to 50%.~      An improvement in our ability to treat GIAD endoscopically is desirable. An ablation catheter~     would need to be easy to use repetitively through the enteroscope, be more maneuverable to~     direct treatment to the lesions, and also cover more area of intestinal mucosa per treatment~     compared to APC, and it should be low risk for damage to the healthy intestinal mucosa.~      Radiofrequency ablation (RFA) may hold the answer. It's efficacy for treatment of superficial~     Barrett esophagus is undisputed, and it has recently been used with success to treat gastric~     antral vascular ectasia (GAVE) a condition which is remarkably similar to GIAD.~   "
18836|NCT03320382|"~     Monitoring patients with chronic, inflammatory airways disease particularly in the early~     stages is hampered by the relative insensitivity of current outcome measures to detect subtle~     changes. Multiple breath washout is a potential sensitive test that is a useful readout of~     disease at these early stages but it lacks standardisation and knowledge of variability with~     reference to standard lung function measures. This is a Cross sectional and longitudinal~     observation study. The hypothesis is that multiple breath washout-derived indices will~     provide a robust signal of gas mixing inhomogeneity, correlating with conventional measures~     of airway disease severity. Multiple breath washout performed on different devices will~     generate indices which correlate but differ in value.~   "
18837|NCT03320369|"~     The purpose of this study is to investigate the effect of an elemental diet on adult patients~     with Eosinophilic Gastroenteritis~   "
18838|NCT03320356|"~     Degenerative lesions of the shoulder occur very frequently and their incidence increases with~     age. The Constant-Murley score is currently considered the gold standard in Europe to assess~     the shoulder and is widely used by the orthopaedic community to follow up on shoulder~     pathologies. However, healthcare professionals are taking an increasing interest in~     self-administered patient-reported out-come measures. Several self-administered~     questionnaires are available to assess the shoulder. Among these questionnaires, the OSS~     (Oxford Shoulder Score) is considered to be quick, simple, and reliable for the~     English-speaking population. This score was initially developed at the University of Oxford~     in 1996. It is a self-administered questionnaire designed to evaluate pain and shoulder~     function through 12 questions. This score has since been adapted in different languages but~     not in French.~   "
18839|NCT03320343|"~     The investigators hypothesize that diffusion tensor imaging (DTI) will produce a similar map~     of autonomic pelvic innervation to that obtained using 3D morphological MRI sequences~   "
18840|NCT03320330|"~     This phase I/II trial studies the side effects and best dose of anti-SEMA4D monoclonal~     antibody VX15/2503 (VX15/2503) and to see how well it works in treating younger patients with~     solid tumors that have come back after treatment, or do not respond to treatment. Monoclonal~     antibodies, such as VX15/2503, may interfere with the ability of tumor cells to grow and~     spread.~   "
18841|NCT03320317|"~     Colorectal cancer is the most common cancer in Europe and the third worldwide. Approximately~     1 in 20 men and 1 in 35 women will develop colorectal cancer at some moment in their life. In~     Flanders, in 2014, there was an increase in the detection of colorectal cancer with 21%~     compared to 2013. Early detection improves the prognosis for the patient. In this early~     stage, colorectal surgery is one of the most important treatments, but it is also complex and~     has a high complication rate. However, over the last decade, surgical care for patients with~     colorectal cancer has become more standardized. The use of structured care methods, such as~     care pathways and protocols, has helped in standardizing care processes. Specifically for~     patients with colorectal cancer, perioperative care has shifted with the implementation of~     Enhanced Recovery After Surgery (ERAS) programs. The goal of ERAS- protocols is to optimize~     the interventions during the perioperative hospitalization period and reduce postoperative~     complications. Despite the increasing evidence in favor of the use of these standardized~     protocols, adherence and implementation in daily practice remains challenging.~      The primary goal of this quality improvement project is to enhance the standardization of key~     interventions in the ERAS care process for patients undergoing colorectal surgery.~      Therefore, adherence to the ERAS-guidelines will be investigated and hospitals will receive~     feedback to set up improvement initiatives. Moreover, interactive group sessions and on-site~     training activities will stimulate knowledge sharing and define best practices.~   "
18842|NCT03320304|"~     The primary objective of this study is to assess short, mid and long-term clinical outcomes~     in patients with difficult to treat depression (such as patients with treatment resistant~     depression) treated with Vagus Nerve Stimulation (VNS) Therapy as adjunctive therapy.~   "
18875|NCT03319875|"~     Epiduroscopy or spinal endoscopy is the imaging of the epidural space using a percutaneous~     and minimally invasive fiberoptic imaging device. The definitive diagnosis and treatment of~     chronic pain is increasingly prevalent with epiduroscopy. Recently, as a result of these~     studies it has been reported that laser therapy with epiduroscopy applied discectomy during~     multiple lesions. Investigators aimed to retrospectively investigate the efficacy of~     epiduroscopic discectomy procedures performed at the Algology Clinic.~   "
18843|NCT03320291|"~     In a society based on the use of everyday tools and objects, the loss of function of one or~     both thumbs due to Rhizarthrosis can drastically reduce the quality of life. Many patients~     are refractory to preservative treatments.Therefore, multiple arthroplasty techniques were~     developed.~      Trapeziectomy, with or without tendon interposition, gives very good results in terms of~     pain, function or force. However, it can result in a reduction of the size of the column of~     the thumb, therefore leading to a loss of force.~      Replacement of the trapezo-metacarpal joint with prosthetic material is also proposed and has~     the advantage to avoid the reduction of the thumb column. Several models are available, mono~     or bipolar, with a conical or hemispherical cup. Another option is the placement of implants.~     They were first used when a partial trapeziectomy was possible to counter the collapse of the~     column and are made of different materials such as metal, silicone, ceramic, pyrocarbon , and~     gelfoam.~      The bioabsorbable poly-LD-lactide implant (PLDLA) is a relatively new possibility for the~     reconstruction of small joints. Studies have previously revealed that the PLDLA implant is~     biocompatible and represents a good alternative to arthroplasty by tendon interposition in~     the reconstruction of the trapezo-metacarpal articulation with osteoarthritis.~      In this study, the investigators will investigate the long term effects (1 year after~     placement) of the Regjoint, a poly-LD-lactide implant (PLDLA).~   "
18844|NCT03320278|"~     Difficult intubation is considered one of the most important obstacle increasing mortality in~     anesthesiology. Airway assessment tests are proceeded to overcome these difficulties in the~     pre-anesthetic evaluation. In this study, the Simplified Predictive Intubation Difficulty~     Score (SPIDS) and Thyromental Height Measurement (TMH) were chosen as primary methods to~     predict difficult intubation. Total 155 ear-nose-throat (ENT) and Plastic Surgery patients~     were planned to enroll this study to assess the effectiveness of these tests in predicting~     difficult intubation in 155 in Maltepe University Hospital and Sisli Hamidiye Etfal~     Governmental Hospital.~      The SPIDS of volunteers will be calculated according to their previous knowledge of difficult~     intubation, airway pathologies, head and neck movements, mouth opening, modified Mallampati~     test and thyromental distance. TMH value will be measured with ASIMETO depth device. Finally,~     the SPIDS and TMH values will be statistically compared to predict difficult intubation which~     is determined with difficult intubation score (IDS).~   "
18845|NCT03320265|"~     Inflammation and abnormal amount of lipids in the blood are key factors for the development~     and progression of atherosclerosis (thickening of the artery wall) and cardiovascular~     disease. Lipoprotein (a) is a pro-inflammatory plasma lipoprotein that is believed to be a~     risk factor for cardiovascular diseases. Vascular inflammation generates a range of effects,~     including endothelial dysfunction and migration of white blood cells into the vessel wall,~     which results in increased risk of cardiovascular events.~      This study is designed to assess the effects of multiple monthly intravenous infusions with~     the fully human antibody called PC-mAb, in subjects with elevated lipoprotein (a).~   "
18846|NCT03320252|"~     The purpose of the post-market study is to assess the clinical outcomes, safety, and~     performance of the Endurant Chimney Graft Technique (Endurant Stent Graft Systems used with a~     balloon-expandable covered stent graft) for treatment of juxtarenal aortic aneurysms with a~     short infrarenal neck in a real world setting.~   "
18847|NCT03320239|"~     The objective of the study is to evaluate the effectiveness of a HIV risk assessment tool to~     promote HIV testing and to reduce high risk sexual behaviors among men who have sex with men~     (MSM). It hypothesizes that the social media-based HIV risk assessment tool can increase 20%~     HIV testing proportion during the six months follow-up period.~   "
18848|NCT03320226|"~     The purpose as well as the aim of this project is to understand the effect of probiotics on~     gastrointestinal (GI) dysfunction such as nausea, vomiting, and constipation that are found~     during the first and second trimesters of pregnancy.~      The primary objective of this project is to uncover whether probiotics have an effect on GI~     functional disorders.~      The secondary objective is to identify the microbiota associated with probiotic intake.~      The tested hypothesis is that gut microbiota influences the GI functions and may influence~     constipation, nausea, and vomiting during pregnancy.~   "
18849|NCT03320213|"~     evaluation of serum CA125 level and yolk sac morphology in women with threatened miscarriage~     is very important to predict pregnancy outcome~   "
18850|NCT03320200|"~     The aim of this study is to compare the effectiveness of a CNS-directed treatment program~     versus a standard medical and physiotherapy care program on outcomes in participants with~     FS.Participants will be randomized to receive either a 10 weeks CNS-focused treatment program~     or standard medical and physiotherapy care.To evaluate the results of the interventions, the~     subjects will be assessed at the beginning, at the end of the treatment program (week 10) and~     at 3 and 6 months of follow-up.~   "
18851|NCT03320187|"~     This study aims to establish the efficacy of transdermal glyceryl trinitrate as a nitric~     oxide donor in addition to dinoprostone for induction of cervical ripening in the third~     trimester through progression in the Bishop's score during 24 hour period.~   "
18852|NCT03320174|"~     This randomized, double-blind, placebo controlled study will involve 600 healthy~     (Glucose-6-Phosphate Dehydrogenase [G6PD] normal) volunteers. Participants who meet the~     eligibility criteria will be randomized (ratio 1:1) to receive a loading dose of either~     tafenoquine 200 mg (2 x 100 mg tablets) or placebo daily for three consecutive days, followed~     by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks, with safety~     follow-up visits at Weeks 4, 12, 24, and 52. All participants will return to the clinic at~     Week 64 for an end of study visit. If the participant has an ongoing AE at the Week 64 visit~     will continue to be assessed for up to 3 more times at approximately 12-week intervals or~     until resolution or stabilization of the AE whichever is earlier.~   "
18876|NCT03319862|"~     The massive weight loss leads an important excess of skin on thoracic level giving the aspect~     of a feminine breast with a relatively important ptose. Several techniques were described in~     the literature about gynaecomastia , but the post-bariatric pseudo-gynaecomastia was not~     handled yet enough. Moreover, there is no single consensual technique on this subject. The~     technique used in this service was described for the first time in 2008 ( 1 ) on a serie of 8~     patients with an average follow-up of 13 months. Although the results are promising, no other~     publication was done, and the procedure remains badly represented in the world literature.~   "
18853|NCT03320161|"~     In oncology, supportive care should be used along with curative treatment or palliative care~     in order to improve patients' health-related quality of life, overall survival and to better~     support treatment side effects as well as the disease evolution. Unfortunately, they are not~     widely used in clinical practice.~      A direct assessment of the needs perceived unmet by patients could allow to assess the~     magnitude of expectations to better target treatments as example. A prospective assessment of~     the expectations and needs of the patients is thus essential. This would also allow help to~     highlight the convergence between supportive care proposed and used and those expected by~     patients. The first step to understanding how to optimize the use of resources and to improve~     the quality of care is to identify patient's expectations. Moreover, it is now well~     recognized that patients should play a key role in the research and that their active~     participation in research can increase the relevance of the research.~      In this context, the CyPRES project aims to:~        1. assess through national consensus the patients' expectations in terms of supportive care~          in order to help both clinicians and health care services;~        2. prioritize them and to arrange resources according to priority needs identified;~        3. identify supportive care for which no previous research (evidence-based medicine) has~          demonstrated their usefulness. A randomized clinical trial will thus be proposed;~        4. Involve patients in the written, conduct and analyses, as well as communications of the~          randomized clinical trial.~   "
18854|NCT03320148|"~     This is a pilot cluster randomized controlled trial to determine the feasibility of a cluster~     randomized trial to evaluate the individual and health system impact of implementing a new~     physiotherapist-led primary care model for back pain in Canada.~   "
18855|NCT03320135|"~     The aim of the present study is to evaluate the clinical response of proximal furcations~     treated with enamel matrix derivative proteins (EMD).~   "
18856|NCT03320122|"~     Using a randomized trial design, the goal of this project is to prospectively compare~     outcomes from a telemedicine-based model of care to two cohorts: patients who receive~     in-person pediatric physiatrist medical direction (the gold standard), and those who~     receive medical oversight from non-specialist community providers. This project will~     determine the impact of this new model of care using telemedicine on parent/guardian~     satisfaction, adherence rates to an evidence-based hip surveillance program, and economic~     efficiency.~   "
18857|NCT03320109|"~     Serum 25(OH)D, dietary and supplemental vitamin D were shown to influence cognitive outcomes~     in large epidemiological studies. Sex/age-specific and race-specific associations of vitamin~     D status and intake were examined with longitudinal change in various cognitive domains in a~     large sample of ethnically and socio-economically diverse US urban adults. Two prospective~     waves of data from Healthy Aging in Neighborhoods of Diversity across the Life Span (HANDLS)~     study were used, specifically visit 1: 2004-2009 and visit 2: 2009-2013, mean follow-up~     time±SD: 4.64±0.93y. Cognitive performance was assessed using 11 test scores covering domains~     of global cognition, attention, learning/memory, executive function,~     visuo-spatial/visuo-construction ability, psychomotor speed and language/verbal. Serum~     25(OH)D, vitamin D intake and use of supplements containing vitamin D were the key exposures.~     Multiple mixed-effects linear regression models were conducted, (N=1,231-1,803, k=1.5-2.0~     observation/participant).~   "
18858|NCT03320096|"~     To evaluate the Ulthera® System and the 7-3.0mm transducer for treating axillary~     hyperhidrosis.~   "
18859|NCT03320083|"~     Behavioral Insomnia of Childhood (BIC) is among the most prevalent problem presented to~     pediatricians with a reported occurrence of approximately 30% worldwide.The most widely~     applied treatment strategies for BIC in infants comprise behavioral procedures such as~     unmodified extinction; graduated extinction (ignoring the infant cries with minimal checks),~     or camping out. Unfortunately, breastfeeding is usually considered as an undesirable sleep~     association in these strategies. Moreover, less is known regarding the effects of these~     interventions on breastfeeding outcomes. The cued care is defined as a pattern of care~     characterized by sensible caregiver responsiveness, which meets the need underlying the~     infant's cues in a flexible manner. In this context, POSSUMS has been developed as a cued~     care sleep intervention, which is quite different from the conventional sleep training~     techniques. In the current study, investigators hypothesized that mothers receiving the cued~     care sleep intervention would report less sleep problems in their infants. Secondary outcomes~     included improvement in maternal mood and maintenance of the breastfeeding during the~     observation period.~   "
18860|NCT03320070|"~     The purpose of this study is to evaluate the efficacy and safety of H.P. Acthar® Gel (Acthar)~     in the treatment of pulmonary sarcoidosis.~   "
18861|NCT03320057|"~     This mixed-methods study follows a prospective cohort of patients receiving Mifeprex ®~     (mifepristone) for medication abortion dispensed by pharmacists after undergoing standard~     clinical evaluation. Women participating in this study will obtain mifepristone and~     misoprostol from the pharmacy instead of in the clinic. To assess feasibility, acceptability,~     and effectiveness of pharmacy dispensing of mifepristone, the study will survey patients,~     evaluate their clinical outcomes from electronic health records, and survey and interview~     pharmacists at study sites.~   "
18862|NCT03320044|"~     Analyse immune repertoire and genetic mutations of benign and malignant pulmonary nodule，and~     evaluate peripheral blood detection for identifying nature of pulmonary nodule.~   "
18877|NCT03319849|"~     This study is a phase 3, randomized, multi-center study to evaluate the efficacy and safety~     of the Renexus® implants in participants with macular telangiectasia type 2.~   "
18878|NCT03319836|"~     This is a retrospective study of protein and energy intake in enterally fed critically ill~     adult patients before and after the introduction of a very high protein enteral nutrition~     formula in a single center medical/surgical ICU.~   "
18879|NCT03319823|"~     This is a protocol to obtain pilot data to submit a new NIH grant on Nocturnal Hypertension~     and Nocturia. In the diversity supplement to Dr. Victor's current NIH grant (Cut Your~     Pressure Too: The Los Angeles Barbershop Blood Pressure Study) the results show that~     uncontrolled systolic hypertension is an independent determinant of nocturia in African~     American men.~      the investigators now want to pursue this correlation by designing a new NIH grant proposal~     to determine whether replacing short acting with long acting drugs and dosing them at bedtime~     rather than in the morning will: A. Lower systolic blood pressure during sleep B. Improve~     nocturia and result in better sleep quality~   "
18863|NCT03320031|"~     In china, there are the most population of type 2 diabetes mellitus (DM) among the world and~     DM becomes currently the second cause for end-stage renal disease (ESRD). Nearly 50% of~     insulin-treated PD patients in clinical practice are treated with premixed insulin. Glycemic~     control in them is very difficult to be achieved mainly due to the uremic status of these~     patients and glucose exposure from peritoneal dialysate, a higher glycemic variability and~     higher risk of hypoglycemia. Linagliptin, unlike other DPP-4 inhibitors, has a primarily~     non-renal elimination route, and does not require dose adjustment for any level of impaired~     renal function. The aim of this study is to evaluate the effect of linagliptin on glucose~     variability and glycemic control in peritoneal dialysis patients with type 2 diabetes who are~     inadequately controlled with premixed insulin therapy.~      This will be a randomized, double-blind, placebo-controlled, parallel group study to evaluate~     the effect of linagliptin on glucose variability and glycemic control in peritoneal dialysis~     patients with type 2 diabetes who are inadequately controlled with premixed insulin~     therapy.which will be conducted in 8 diabetes centres and/or nephropathy departments in~     China. After a 4-week run- in period, 232 participants are randomized (1:1) to either~     premixed insulin combined with linagliptin (5mg/d) group (also named combined group) or~     premixed insulin alone group (also named insulin group) for 12 weeks. Finally, the primary~     endpoint is glucose variability indicated by MAGE, secondary endpoints include HbA1c, FPG,~     PPG, LAGE, SDBG, PT10.0, PT3.9, 1h fasting MBG, 3h postprandial MBG, insulin dosage,~     hypoglycemia and body weight.~   "
18864|NCT03320018|"~     This is a pilot randomized control trial (RCT) to explore the possible beneficial effect of a~     novel combination therapy consisting of molecular hydrogen H2 plus minocycline (H2M), on~     neurological recovery after acute ischemic stroke.~   "
18865|NCT03320005|"~     This comes from a non-randomized clinical trial, which aims to check on elderly women the~     effects of a program of resistance training (TR) in physical performance, in respiratory~     functional capacity, on health and quality of life.~   "
18866|NCT03319992|"~     The aim of this study is to evaluate the effects of an assisted rehabilitation treatment~     through a robotic exoskeleton device on the functional recovery in a group of patients with~     hemiparesis from lesion of the first motor neuron (post-stroke), compared with a group of~     patients subjected to a conventional rehabilitation treatment. The patients enrolled in the~     study are chronic stroke injured with right hemiparesis of moderate to severe degree, by the~     system injury pyramid, never undergoing rehabilitation treatment with robots.~   "
18867|NCT03319979|"~     A genetic variation in the gene for the protein dihydrofolate reductase (DHFR) that is~     necessary to utilize folic acid (a synthetic form of the B vitamin folate found in~     supplements and fortified food), increases the risk for breast cancer in multivitamin users~     and, when present in mothers who used folic acid supplements during pregnancy, increases the~     risk for cancer of the eye of their children. The aim of the proposed research is to~     understand how a common genetic variation in the gene for DHFR affects the function of this~     protein and the ability of the body to use folic acid.~   "
18868|NCT03319966|"~     The purpose of this single center, longitudinal, pilot study is to provide evidence for the~     use of an eye tracking system as an objective tool to identify mild traumatic brain injury~     (mTBI) related oculomotor dysfunction (OMD) and predict the effectiveness of neurovision~     rehabilitation (NVR) of OMD. Eye tracking visual stimulus measurements will be compared to~     objective developmental optometrist (OD) diagnosis and assessments. It will be determined~     whether an eye tracking system can predict the presence or absence of mTBI related OMD and~     whether mTBI patients who have OMD based on the eye tracking system will respond positively~     to NVR.~   "
18869|NCT03319953|"~     The purpose of the study is to determine whether motivation/reward deficits observed in~     schizophrenia are attenuated and whether cognitive impairment associated with schizophrenia~     is improved by add-on TAK-041 administration to antipsychotics in participants with stable~     schizophrenia.~   "
18870|NCT03319940|"~     A study to assess the safety, tolerability, and pharmacokinetics of AMG 757 in Subjects with~     Small Cell Lung Cancer~   "
18871|NCT03319927|"~     To reduce the risk of adverse health problems associated with chronic exposure to pesticides,~     a randomized control study will evaluate a nurse-led integrated pest management (IPM)~     intervention in 88 child care centers serving socio-economically and ethnically diverse~     preschool-age children in four California counties. Positive changes in IPM knowledge,~     policies, practices, pests, and pesticide exposure will be assessed.~   "
18872|NCT03319914|"~     This is an 8-week observational follow-up study of patients who participated in the ST-001~     CALISTA study (A Phase 3, Intravenous Sodium Thiosulfate for Acute Calciphylaxis Treatment: A~     Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial).~   "
18873|NCT03319901|"~     This research study is studying a medication called Venetoclax and a chemotherapy regimen as~     a possible treatment for Acute Lymphoblastic Leukemia.~      The drugs involved in this study are:~        -  Venetoclax~        -  Standard Chemotherapy (which includes cyclophosphamide, vincristine, doxorubicin,~          dexamethasone, methotrexate, 6-mercaptopurine, etoposide, and cytarabine~   "
18874|NCT03319888|"~     Objectives: Evaluate the effect of CPAP to reduce the progression of chronic kidney disease~     or CKD (the decline of glomerular filtration rate is ≥ 30%) in patients with early-stage~     renal disease and sleep apnea syndrome (OSAS). Other objectives are; determine the prevalence~     of OSAS in patients with early-stage renal disease and evaluate the changes in inflamatories~     markers and endothelial damage, the state of KDIGO, cardiovascular events, mortality and~     cost-effectiveness analysis in CPAP group versus non-CPAP group patients.~      Methods: A prospective, multicentric, randomized and controlled study will be carried out for~     3 years. Early-stage renal disease (G1-3 KDIGO) and OSAS patients will be included. The~     investigators will make a respiratory polygraphy to determinate OSAS (AHI ≥15/h) and after~     that, the investigators randomized patients in 2 groups; CPAP group and control group~     (non-CPAP treatment). Patients with AHI <15/h (non-OSAS) will be the reference group and the~     half of these patients, randomly chosen, will be followed up at the end of the follow up.~      Statistic analysis: the investigators will analyze the differences in glomerular filtration~     rate before and after the treatment, comparing the percentage of patients with CKD~     progression for both groups. The investigators will use the chi square test with raw data and~     adjusted for confounding variables using intention to treat analysis with imputation of~     missing values.~   "
18882|NCT03319784|"~     Sixty patients will be identified in the clinic with rotator cuff tendonitis or a low-grade~     partial-thickness tear of the rotator cuff that are either insulin-dependent or~     insulin-independent diabetics. Patients will be informed about the current prospective study~     and written consent will be obtained. Patient information about kidney function, current~     diabetic medication type, dose and frequency will be obtained in clinic. If there is a~     diagnosed kidney function abnormality, the patient will be excluded from the study. Patients~     will be asked about their most recent HbA1C. If HbA1C has not been checked within the past 3~     months, the patient will have HbA1C checked in the lab either same day as the injection or~     the following day. Patients will be randomized into two patient groups: Toradol (Ketorolac)~     injection group (n=30) and or Steroid injection group (n=30). The randomization will be done~     using an online randomization tool: http://www.graphpad.com/quickcalcs/index.cfm.~      Patients assigned to Toradol group will receive 60mg of Toradol (Ketorolac) mixed with 8mL of~     1% lidocaine with epinephrine 1:100,000. Those assigned to Steroid group will receive 80mg of~     Kenalog (Triamcinolone Acetonide) mixed with 8mL of 1% lidocaine with epinephrine 1:100,000.~      Patients will be blinded to the kind of injection they receive, but the physicians who~     perform the injection will not be blinded for the medical record purposes. The injection will~     be done under ultrasound guidance to the subacromial space. Continuous blood glucose~     measurement will be started in an hour within the injection. An instructional session about~     continuous glucose monitoring will be given to the patients by our research team immediately~     following the injection. The blood glucose levels will be monitored for 1 week following the~     injection. The data will be collected on the patient's return to clinic in 2 weeks. Pain~     score based on a visual analog scale will be obtained prior to injection, 5 min, 3 days, 1~     week, 2 weeks, 4 weeks, 6 weeks, 8 weeks, and 12 weeks after injection. Shoulder range of~     motion, patient satisfaction, QuickDash score, and ASES survey score will be measured in~     clinic 4, 8, and 12 weeks after injection.~   "
18883|NCT03319771|"~     The two primary study objectives involve examining the effects of treadmill walking exercise~     training versus stretching-and-toning activities on the primary and secondary outcomes.~      Specific Aim 1: The first specific aim is to examine the effects of 3-months of treadmill~     walking exercise training compared with an active control condition on learning and memory~     outcomes in fully-ambulatory persons with MS who have impairment in learning new information.~     We hypothesize that those who undergo treadmill walking exercise training will demonstrate~     improvements in learning and memory relative to those who undergo stretching-and-toning~     activities.~      Specific Aim 2: The second specific aim is to examine the effects of 3-months of treadmill~     walking exercise training compared with an active control condition on hippocampal volume,~     hippocampal resting-state functional connectivity, and cardiorespiratory fitness in those~     persons with MS. We hypothesize that those who are randomly assigned to the treadmill walking~     exercise condition will demonstrate increases in hippocampal volume and resting-state~     functional connectivity (i.e., adaptive increases) and improved cardiorespiratory fitness~     relative to those in the stretching-and-toning condition.~   "
18884|NCT03319758|"~     The objective of this prospective clinical trial is to compare the esthetic and radiographic~     outcomes following immediate implant placement with or without labial plate dehiscence~     defects using bone augmentation in combination with an absorbable collagen membrane.~   "
18885|NCT03319745|"~     The goal of this clinical research study is to learn about the safety and efficacy of giving~     pembrolizumab before a cystectomy (a surgery to remove the bladder) to patients with~     urothelial carcinoma of the bladder.~      This is an investigational study. Pembrolizumab is FDA approved and commercially available to~     treat many types of cancer, but not bladder cancer. It is considered investigational to use~     pembrolizumab to treat bladder cancer.~      The study doctor can explain how the study drug is designed to work.~      Up to 20 participants will be enrolled in this study. All will take part at MD Anderson.~   "
18886|NCT03319732|"~     Spasticity is a common complication in MS and occurs in up to 84% of patients. The main sign~     of spasticity is resistance to passive limb movement characterized by increased resistance to~     stretching, clonus, and exaggerated deep reflexes. Osmotica Pharmaceutical is currently~     developing arbaclofen extended-release tablets (AERT) for the treatment of spasticity in~     patients with MS.~   "
18887|NCT03319706|"~     Subjects to compare the single dose bioavailability of Torrent's Olmesartan Medoxomil Tablets~     40 mg and Benicar® 40 mg Tablets of Daiichi Sankyo Inc., USA. Dosing periods of studies were~     separated by a washout period of 7 days.~   "
18888|NCT03319693|"~     Primary mucosal melanomas (MPM) are rarer than cutaneous melanomas, but also more severe.~     They are usually refractory to conventional approaches, regularly excluded from major~     therapeutic programs and not sensitive to new targeted therapies orphans.  The~     identification of therapeutic targets and accessibility to existing, developing or future~     targeted therapies improves the survival of patients with MPM.~      The principal goal is to describe, using a large panel of genes, the prevalence of major~     mutations in a cohort of MPMs based on the population of a French region.~   "
18889|NCT03319680|"~     Prospective randomized cross-over multicenter study to demonstrate the benefits of~     hemodialysis without acetate dialysate, with citrate.~      32 weeks duration, in two phases. In the first, half of the patients started with citrate~     dialysate for 16 weeks and the other half with acetate dialysate, and then patients cross.~      The primary objective is to analyze the effect of citrate dialysate on acid base balance~     decreasing chronic metabolic acidosis and avoiding / reducing post-dialytic alkalosis.~   "
18890|NCT03319667|"~     Primary Objective:~      To demonstrate the benefit of isatuximab (I) in combination with bortezomib (V), lenalidomide~     (R) and dexamethasone (d) in the prolongation of progression free survival (PFS) as compared~     with bortezomib, lenalidomide and dexamethasone in patients with newly diagnosed multiple~     myeloma (NDMM) not eligible for transplant.~      Secondary Objectives:~        -  To evaluate in both randomized arms: very good partial response (VGPR) or better rate as~          defined by the International Myeloma Working Group (IMWG) criteria, complete response~          (CR) rate per IMWG criteria, minimal residual disease (MRD) negativity rate in patients~          with CR or VGPR, time to progression (TTP), PFS in MRD negative patients, duration of~          response (DOR), PFS on next line of therapy (PFS2), overall survival (OS), overall~          response rate (ORR) (including crossover arm) per IMWG criteria (including crossover~          arm), safety (including crossover arm), and to assess disease-specific and generic~          health-related quality of life (HRQL)~        -  To determine the pharmacokinetic (PK) profile of isatuximab in combination with~          bortezomib, lenalidomide, and dexamethasone (excluding crossover arm)~        -  To evaluate the immunogenicity of isatuximab in patients receiving isatuximab (including~          crossover arm)~   "
18904|NCT03319485|"~     Evaluate the safety and efficacy of unilateral focused ultrasound pallidotomy using the~     ExAblate 4000 System in the management of dyskinesia symptoms or motor fluctuations for~     medication refractory, advanced idiopathic Parkinson's disease.~   "
22237|NCT03275974|"~     The clinical trial studies how well 11C-glutamine and 18F-FSPG positron emission tomography~     (PET) imaging works in detecting tumors in patients with metastatic colorectal cancer~     compared to standard imaging methods such as magnetic resonance imaging (MRI) or computed~     tomography (CT) scanning.~   "
18891|NCT03319654|"~     Infertility affects about 10% of all couples and is defined by a failure to achieve a~     clinical pregnancy within a year of regular unprotected sexual intercourse. Up to one third~     of these couples will not have an identifiable cause after routine investigation, id est~     idiopathic infertility. The current diagnosis of male infertility relies on the World Health~     Organization (WHO) 2010 criteria which focus on concentration, motility and morphology in~     comparison to cut-off values of a fertile population. Alas, the relevance of the conventional~     semen analysis for the choice of treatment and the predictive value for an infertile couple~     with idiopathic or mild male infertility embarking on medically assisted reproduction (MAR)~     remains questionable. In other words, there is a strong clinical need to distinguish fertile~     from infertile men through new sperm function testing and to be able to select both the~     patient population who will benefit from MAR as well as the type of treatment.~      Numerous studies utilizing different techniques for assessing sperm DNA fragmentation support~     the existence of a significant association between sperm DNA damage and pregnancy outcomes.~      In this prospective cohort study the investigators aim to study the role of sperm DNA~     fragmentation analysis in selecting the patient who will benefit from intra-uterine~     insemination (IUI) therapy since IUI is still considered the first step in MAR and is~     performed at a large scale in Belgium and worldwide.~   "
18892|NCT03319641|"~     Diagnostic study which evaluates the level of PSMA expression in patients with locally~     advanced, recurrent and/or metastatic ACC/SDC of ≥18 years old with 68Ga-PSMA-PET/CT imaging~     in order to establish whether these patients are eligible for 177Lu-PSMA therapy~   "
18893|NCT03319628|"~     First-in-human, Phase 1b safety study of the antibody-drug conjugate (ADC) XMT-1536~     administered as an intravenous infusion once every three weeks. Patients with tumor types~     likely to express NaPi2b will be enrolled. In addition to safety assessments, the~     pharmacokinetics of the drug will be assessed along with ADC activity.~   "
18894|NCT03319615|"~     The present study was based on secondary analysis using the non-intervention control~     conditions of five separate studies with common measures. The current analysis examine the~     indirect and direct effects of fat-free mass, fat mass and resting metabolic rate on energy~     intake in individuals at or close to energy balance.~   "
18895|NCT03319602|"~     The aim of this study is to determine the effect (on PaO2) of a modified mask associated to~     nasal cannula used for high flow oxygenation.~   "
18896|NCT03319589|"~     This study is a randomized controlled pilot for a future larger trial. The goals of this~     pilot are: a) to assess feasibility of delivering a locally prepared supplement in rural~     communities, and b) to generate pilot data for sample size estimates needed for a larger~     trial. The study will test the effect of a supplement prepared locally with local and~     imported ingredients on changes in standard anthropometric benchmarks of growth, cognition,~     immune function, hemoglobin and skin carotenoids in young children living in 2 villages in~     rural Guinea-Bissau. Children in the active intervention village will be compared with~     assessment-only controls in a separate village having comparable demographic characteristics.~     As part of the study, we will assess the feasibility of having local commercial bakers~     prepare the supplement.~   "
18897|NCT03319576|"~     This study plans to learn more about the safety of early feeding following placement of a~     feeding tube. Doctors in other specialties feed patients 4 hours after patients receive a~     feeding tube. However, Interventional Radiologists typically wait to feed patients for 24~     hours following feeding tube placement. The investigator would like to demonstrate that~     feeding after 4 hours does not increase complications and can actually reduce the burden to~     patients who receive a feeding tube.~   "
18898|NCT03319563|"~     Since the first spinal fusion by Hibbs 1911, yet anesthesia for correction of scoliosis is~     challenging due to frequently associated co-morbidities, the extensive nature of surgery and~     liability for many complications. Among the major concerns for anesthesiologists are the pain~     and bleeding. Scoliosis correction accounts for massive blood loss that may exceed more than~     half of blood volume. There are many strategies for blood conservation; however sometimes~     some of them may not be suitable. For analgesia, the most frequently loco regional analgesic~     techniques in spine surgery are intrathecal, epidural or local infiltration techniques.~     infiltration data reviled inconclusive and heterogeneous results. Our purpose is to optimize~     blood conservation and analgesia through anatomically based modification of the infiltration~     technique.~   "
18899|NCT03319550|"~     This study compares three different protein supplements (casein, whey and leucine-enriched~     whey) and their effect on post-inflammatory muscle waste in a model of acute disease. Each~     test person will undergo all three interventions.~      It is believed that leucine is the primary driver of muscle protein synthesis and therefore~     we hypothesize that leucine-enriched whey and whey are superior to casein in combating~     post-inflammatory muscle waste, because of its higher leucine content (16%, 11% and 9%~     leucine, respectively).~   "
18900|NCT03319537|"~     The purpose of this study is to test any good and bad effects of activity pevonedistat taken~     alone, and also to test the safety of pevonedistat in combination with standard chemotherapy,~     pemetrexed/cisplatin.~   "
18901|NCT03319524|"~     This study is aimed to characterize Russian population of Usher patients.~   "
18902|NCT03319511|"~     General anesthesia is the conventional technique used for breast surgery. breast surgery is~     associated with a high incidence of postoperative pain, it is estimated that over 50 % of~     women suffer chronic pain following breast cancer surgery. Regional anesthesia is a good~     alternative to general anesthesia for breast cancer surgery, providing superior analgesia and~     fewer side effects related to a standard opiate-based analgesia. there is no evident optimal~     regional techniques for operative procedures on the breast and axilla, like high thoracic~     epidural, cervical epidural, paravertebral block, intrerpleural block, PECs block, serratus~     plane block and segmental thoracic spinal anesthesia. Regional anesthesia decreases operative~     stress, provides beneficial hemodynamic effects especially for critically ill patients and~     decreases postoperative morbidity and mortality. Also it reduces post‑operative nausea and~     vomiting and provides prolonged post‑operative sensory block, minimizing narcotic~     requirements. Additionally, this application positively affects the early start of feeding~     and mobilization.~   "
18903|NCT03319498|"~     The purpose of this study is to examine the effectiveness of peppermint oil to promote~     voiding and reduce urinary catheterization among postpartum women.~   "
18905|NCT03319472|"~     Pleural effusions (PE) are common conditions that signal either infection or cancer. The~     investigators aim to develop, validate, and prospectively assess the MAPED score, a clinical~     score that predicts malignancy at admission. This tool will assist clinicians all over the~     world to rapidly assess the probability of an effusion being malignant within 4 hours of~     admission.~   "
18906|NCT03319459|"~     This is a Phase 1, single-dose, open-label, dose-escalation study. The study will be~     conducted in three parts (i.e. regimens) in an outpatient setting as follows:~        -  Regimen A: FATE-NK100 as a monotherapy in subjects with advanced solid tumor~          malignancies.~        -  Regimen B: FATE-NK100 in combination with trastuzumab in subjects with human epidermal~          growth factor receptor 2 positive (HER2+) advanced breast cancer, HER2+ advanced gastric~          cancer or other advanced HER2+ solid tumors.~        -  Regimen C: FATE-NK100 in combination with cetuximab in subjects with advanced colorectal~          cancer (CRC) or head and neck squamous cell cancer (HNSCC), or other epidermal growth~          factor receptor 1 positive (EGFR1+) advanced solid tumors.~   "
18907|NCT03319446|"~     This is a generic sample collection study for collecting blood, stool, rectal swabs, nasal~     washes, nasopharyngeal aspirates, nasopharyngeal swabs, throat swabs, nasal swabs, and urine~     from human sources. Subjects will be recruited from BioFire Diagnostics employees and from~     the general community. Subjects may be asked about recent or ongoing illness at the time of~     specimen collection and these symptoms will be recorded and attached to the sample. No other~     identifying information will be collected and the samples will be kept anonymous.The samples~     may be used internally or by external sites, such as the clinical study sites, for evaluating~     and determining performance characteristics of in vitro diagnostic devices.~   "
18908|NCT03319433|"~     Spinal anesthesia for caesarean section is invariably associated with variable degree of~     hypotension. Hypotension that occurs may be detrimental to various organ system due to~     inadequate perfusion. Various methods and agents have been tried in order to address this~     problem. However, this calamity is far from over.~      Perfusion index is one such attempt to address the problem of hypotension by predicting which~     group of parturient may develop hypotension. This is a type of non-invasive method of~     assessing the relative vascular tone with the use of pulse oximeter which calculates the~     ration of pulsatile versus the non-pulsatile component of the blood flow. During normal~     physiological changes in pregnancy, there is relative loss of vascular tone which predisposes~     this group of patient to sudden development of hypotension after the sympathetic block due to~     spinal anesthesia.~      Thus, the aim of the study is to use the non-invasive perfusion index data to predict the~     occurrence of hypotension in a parturient so that helps us to guide fluid and other drug~     therapy to address the problem of hypotension.~   "
18909|NCT03319420|"~     Dry eye complaints occur in 5.5 to 33.7% of the population, and are ranked as the most~     frequent symptoms of patients visiting ophthalmologists. Dry eye syndrome is caused by the~     reduced production and/or improper quality of the tear film. One of the causes of reduced~     tear production is Sjögren's syndrome. Sjögren's is estimated to affect up to 4 million~     patients in the US alone. It affects mostly middle aged women (40-50 years of age) with a~     female to male prevalence ratio of 9:1.~      The current study seeks to evaluate the safety and efficacy of LO2A ophthalmic solution in~     the symptomatic treatment of dry eye in patients with Sjögren's syndrome. This study will be~     conducted in compliance with the protocol, GCP,and applicable regulatory requirements.~   "
18910|NCT03319407|"~     Participants to be enrolled in this study will have been scheduled to have laparoscopic~     genitourinary surgery and EPAD monitoring as part of their clinical care intraoperatively.~     Patients scheduled for genitourinary surgery are often at risk for developing nerve injuries~     due to intraoperative positioning.~      Somatosensory evoked potential devices (SSEP) are commonly used to detect pending injury to~     peripheral nerves. The purpose of the present study is to use SSEP monitoring to determine~     the incidence and potential causes of significant changes in SSEP waveforms and correlate~     these changes with neurologic status of the brachial plexus after robotic surgery.~   "
18911|NCT03319394|"~     The First Twenty (TF20) Exercise Training Program and Fire Academy Recruits' Fitness and~     Health was thesis research completed in the Functional Intensity Training Laboratory (FIT~     Lab) at Kansas State University. The purpose was to assess the performance outcomes,~     acceptability, feasibility, and preliminary efficacy of an innovative 14-week Firefighter~     Fitness and Wellness Program. This study explored if TF20 program was a valid preparatory~     program for fire academy recruits training for the physical job of a firefighter compared to~     standard care of taking a college fitness class. It was hypothesized that TF20 group would~     see greater fitness improvements than the comparison group, the training program would be~     acceptable and feasible, and that TF20 group would report higher levels of group cohesion.~   "
18912|NCT03319381|"~     This study investigated whether there were improvements in the in-hospital mortality,~     infection rate, and rate of palliative care among geriatric trauma patients after the~     implementation of new standard operating procedures (SOPs) for the resuscitation room. These~     new SOPs, comprising early whole-body computed tomography (CT), damage control surgery, and~     the use of goal-directed coagulation management, were designed for severely injured adult~     trauma patients~   "
18913|NCT03319368|"~     This study evaluates the feasibility of targeting more frequent gown and glove use for~     specific high risk moments of care in specific nursing home residents in order to prevent~     Staphylococcus aureus (SA) acquisition and infection.~   "
18914|NCT03319355|"~     Therapy for fibromyalgia is a well discussed topic in literature, yet not thoroughly~     evidence-based. Several unicomponent therapies seem to be benificial. Whereas multicomponent~     and multidisciplinary therapy gains importance and revealing promising results, the~     investigators aim to combine two well-known therapies in a program for patients with~     fibromyalgia.~      From clinical experience, a high drop-out rate has been stated. All data will be explored to~     analyse explanatory factors.~   "
18915|NCT03319342|"~     Emerging evidence suggests that both extending kindness towards others and self-kindness~     practices may have beneficial effects on well-being. This randomized pilot clinical trial~     will investigate the efficacy of two kindness interventions -acts of kindness (to self or to~     other) and loving-kindness meditation- for use with early-stage breast cancer survivors.~   "
22238|NCT03275961|"~     The investigators are doing this research study to find out if the Stress Management and~     Resiliency Training (SMART) therapy will help subjects with their major depression treatment.~   "
18916|NCT03319329|"~     Currently there are no study related to Indirect Calorimetry (IC) has been done among~     hospitalised Malaysian ICU adult patients with its racial mix. The aim of this study is to~     perform a cross-sectional study in Malaysian critically ill patients to determine metabolic~     determinants that might influence resting energy expenditure (REE) and to develop predictive~     equation for the estimation of energy requirement using the regression based approach to~     increase the accuracy in calorie prescriptions. In addition, expected outcome of this study~     is to determine which equations have clinical usefulness among Malaysian adult critically ill~     patients and hope to introduce into routine clinical practice in the future if IC is not~     available.~   "
18917|NCT03319316|"~     This is a multicenter, 2-arm open-label, randomized comparative phase II study in each of two~     separate cohorts (non-squamous NSCLC and squamous NSCLC) according to histology.~   "
18918|NCT03319303|"~     During any general anaesthetic which involves muscle relaxation artificial breathing is~     required. This is most commonly provided by pushing air under pressure (positive pressure~     ventilation) into the lungs via a tube in the airway (the tracheal tube). It has been~     observed for many years that with this form of breathing the distribution of gas within the~     lungs differs from that seen during 'natural' breathing: more of the gas goes to the upper~     parts of the lung than lower parts. This change in how the gas is distributed can lead to~     problems with how well oxygen is taken up by blood and carbon dioxide removed from the body.~     Previous work using mathematical modelling has found that the position of the tracheal tube~     might affect air distribution, but this has previously been difficult to study in 'real~     life', requiring the use of radioactive dyes and computerised tomography (CT). However a~     bedside test is now available which allows us to study these changes rapidly and~     non-invasively, using electrical impedance tomography (EIT). The EIT device is commercially~     available (PulmoVista®, Draeger UK) and is used in hospitals worldwide as a bedside monitor~     of lung ventilation.~      This study aims to investigate the effect of tracheal intubation on regional ventilation of~     the lungs by comparing measurements before and after the patient is anaesthetised and~     intubated. We aim to show whether altered patterns of ventilation are caused by patients~     simply being asleep and ventilated, or whether these changes are due to the use of a tracheal~     tube itself. The exact effect of tube position will also be studied by measuring ventilation~     as the tube is deliberately advanced until it enters one of the lungs. This will give us~     information about the ideal position for a tube within the trachea to promote optimal~     ventilation patterns within the lungs~   "
18919|NCT03319290|"~     Observational study is to increase surveillance for breast and ovarian cancers, also to~     determine targeted risk-reducing and preventative strategies.~   "
18920|NCT03319277|"~     This is a randomized controlled trial to determine the effect of decreased post-operative~     prescriptions of opiate medications after urogynecologic surgery.~   "
18921|NCT03319264|"~     Spondylarthropathies (SpA) are among the most common chronic inflammatory rheumatisms in~     adults, responsible for a muscular loss or sarcopenia which can be very disabling, not much~     documented in the literature, and not yet studied in France. In addition, sarcopenia is~     associated with decreased physical activity and increased risk of falls and fractures. A~     better characterization of the determinants of this muscular loss will allow to better detect~     and take care of it.~      The aim is to conduct the first French study on the prevalence and severity of sarcopenia in~     patients with spondyloarthropathies and to study the variables that may be associated with~     it. Finally, we propose to evaluate obesity related to sarcopenia in these patients and~     compare them to cases matched for age and sex (from OFELY / STRAMBO cohorts, Lyon, FRANCE).~      This is a prospective interventional and monocentric study with minimal risks and~     constraints: patients will be included for one day for an evaluation of their sarcopenia by~     measuring their muscle strength, physical performance and body composition and recording of~     their socio-demographic and disease characteristics.~   "
18922|NCT03319251|"~     The purpose of this research is to obtain a blood sample from patients with actinic keratoses~     undergoing routine Photodynamic Therapy, in order to measure biomarkers that are relevant to~     VitD and 5FU metabolism and might be predictive of PDT outcome. The biomarkers to be examined~     include serum VitD levels at the time of PDT, and the presence/absence of gene alleles that~     correlate with expression of several proteins involved in VitD and 5FU metabolism. The~     presence of these biomarkers will be correlated to the improvement in AK lesion counts at the~     patient's routine follow-up visit 3 months after PDT treatment.~   "
18923|NCT03319238|"~     The aim of this study is to evaluate the safety of use, benefits and risks of repeated use of~     ketamine for each patient with chronic pain in different structures of pain management.~   "
18924|NCT03319225|"~     The purpose of this research study is to learn more about the causes of gastrointestinal~     dysfunction after spinal cord injury. It has been thought that the microbiome (the community~     of bacteria in the body) may be one such cause. The study will examine whether changes in the~     distal gut microbiome are related to gastrointestinal dysfunction in persons with Spinal Cord~     Injury and Non-Disabled Controls.~   "
18925|NCT03319212|"~     This is an unmasked, non-randomized, single arm, stratified, dispensing investigation of~     symptomatic and asymptomatic subject populations. Subjects will be assigned to a single study~     lens type to be worn bilaterally for approximately 4 weeks followed by no contact lens wear~     for 1 week.~   "
18926|NCT03319199|"~     L-carnitine is an amino acid that is naturally produced in the liver and kidneys, it is~     involved in transporting fatty acids across the mitochondrial membrane, it could be an~     important component in treating a fatty liver disease.~      The investigators conduct a study to evaluate the efficacy of the combination of L-Carnitine~     and Magnesium as a treatment for fatty liver.~   "
18941|NCT03319004|"~     For verifying the phase lag entropy as the tool for measurement of level of consciousness,~     the investigators compared phase lag entropy to bispectral index. Using Target-Controlled~     Infusion pump, propofol was infused for sedation during the spinal anesthesia. The~     investigators measured Observer's Assessment of Alertness/Sedation Scale as the propofol~     concentration rises. At the same time, The investigators observed phase lag entropy score and~     bispectral index score.~   "
18942|NCT03318991|"~     Benign prostate obstruction (BPO) can be treated with a range of laser treatments using~     different laser systems and applications. Transurethral laser treatment is considered to be~     an alternative treatment to transurethral resection of the prostate (TURP). The latest~     guidelines of the European Association of Urology recommend 532-nm GreenLight laser~     vaporisation of the prostate and thulium laser enucleation as alternatives to TURP. For~     further investigation of the efficacy of GreenLight and thulium laser in treating BPH, the~     investigators organize a prospective randomised control study. The investigators will enrol~     100 patients with BPO, treated with either GreenLight laser or thulium laser prostatectomy,~     and compare their safety and efficacy.~   "
18927|NCT03319186|"~     Malignant Pleural Effusion (MPE) is a collection of fluid inside the chest caused by cancer.~     It is a common medical problem and often causes severe breathlessness. Patients with this~     condition generally have a very poor survival and so it is extremely important that they are~     given effective treatment as soon as possible to minimise the amount of time they have to~     spend in hospital.~      Standard treatment for MPE involves an admission to hospital to drain the fluid and then~     attempt to prevent the fluid from returning by sticking the lung to the inside of the rib~     cage with medical talc powder which acts like glue. This is called talc pleurodesis (TP) but~     unfortunately it fails in about 30% of patients. This is usually because the lung has not~     fully re-expanded and has not made contact with the inside of the ribs. When this happens,~     the fluid can be effectively treated with a different type of drainage tube called an~     indwelling pleural catheter (IPC) which tunnels under the skin and is drained at home by the~     district nurses.~      It is thought that pressure measurements taken from the fluid as it is drained may be able to~     show doctors whether or not the lung will re-expand before patients are committed to either~     TP or an IPC. In this research we wish to test if these measurements can be used to choose~     which is the best first treatment option (TP or IPC) for patients with MPE. We have called~     this 'EDIT management'. Since it is uncertain whether this new approach will work, patients~     will be randomised to have either standard treatment or EDIT management. We will compare the~     two groups to assess whether the patients who had EDIT management had to have fewer repeat~     procedures over the following 3 months.~   "
18928|NCT03319173|"~     The study explores whether selective memory complaints (SMC), mild cognitive impairment (MCI)~     and the comorbidity of Metabolic Syndrome symptomatic of peripheral and cerebral~     hypo-metabolism with corresponding epigenetic shifts in global DNA (deoxyribonucleic acid)~     methylation (away from nutrient availability and toward biosynthesis) are initiated by~     chronic metabolic inflexibility, over-activation of the mTOR (mammalian target of rapamycin)~     pathway, and the deregulation of neural oxidative phosphorylation.~   "
18929|NCT03319160|"~     This post-market study is a prospective observational study evaluating the efficacy and~     safety of the LifeVest in real-life settings.~   "
18930|NCT03319147|"~     The primary objective is to determine the impact of essential amino acids on integrated~     muscle protein synthesis over 4 days after resistance exercise.~      In addition, the secondary objective is to determine the effect of essential amino acids on~     satellite cell regulation and inflammatory responses during this prolonged recovery period.~   "
18931|NCT03319134|"~     The overall objective of this study is to investigate the neural correlate in retrieval~     memory task.~      The aim of the study is to understand the undergoing changes in late positive ERP component~     during retrieval memory task when stimulating the posterior cingulate cortex (PCC) with High~     Definition Transcranial Direct Current Stimulation (HD-tDCS).~   "
18932|NCT03319121|"~     This is a prospective randomised clinical trial performed in a single center at Hospital~     Universiti Sains Malaysia (USM), Kelantan, Malaysia. Participants will be randomly allocated~     into either the empirical group or guided group for 8 weeks.The effectiveness in relieving~     chest pain (frequency and severity) will assessed after 2 weeks and 8 weeks of therapy with~     Gastroesophageal Reflux Disease Questionnaire (GERDQ) and Quality of Life Reflux and~     Dyspepsia (QOLRAD) questionnaire, and visual analogue scale (VAS) (score 1-10).~   "
18933|NCT03319108|"~     Our aim in this study is to determine the distribution of comorbidity in patients with COPD~     participating in the pulmonary rehabilitation program and to examine the effect of severity~     of comorbidy on pulmonary rehabilitation outcomes.~   "
18934|NCT03319095|"~     It is estimated that about 30% of women cannot voluntarily contract the pelvic floor muscles~     (PFM). PFM training (PFMT) represents the first therapeutic option for the treatment of~     female urinary incontinence (UI), however the inability to contract this muscle makes PFMT~     unfeasible. The primary objective of this project is to evaluate clinically the efficacy of~     intravaginal electrical stimulation associated with verbal instructions to provide the~     ability of women to contract voluntary their PFM. The secondary objective is to evaluate the~     UI prevalence and impact on quality of life.~   "
18935|NCT03319082|"~     The objectives of this post market registry are to evaluate the safety and durability of~     treatment effect up to 3 years following cross-linking performed with Photrexa Viscous~     (riboflavin 5'- phosphate in 20% dextran ophthalmic solution), Photrexa (riboflavin 5'-~     phosphate ophthalmic solution), and the KXL System in patients with corneal ectasia following~     refractive surgery.~   "
18936|NCT03319069|"~     The purpose of this study is to compare the efficacy and toxicities of hypofractionated~     radiotherapy with conventional fractionated radiotherapy in high risk breast cancer patients~     treated with mastectomy. It's hypothesized that the efficacy and toxicities are similar~     between the two groups.~   "
18937|NCT03319056|"~     The objective of this study is to investigate the cardiopulmonary health benefits from indoor~     air purification among school students in Beijing.~   "
18938|NCT03319043|"~     This single-center, randomized, double-blind, placebo-controlled trial was undertaken at an~     outpatient clinic in Shuguang Hospital. Newly diagnosed cough variant asthma adult patients~     with the T.C.M. pattern of pathogenic-wind are randomly divided into treatment and control~     group, with 60 patients in each group. Clinical observation of the Respiratory Impedance and~     Inflammation in Cough Variant Asthma adults reated in Combination of Chanqin Granules.~   "
18939|NCT03319030|"~     This research study wants to learn more about Duchenne Muscular Dystrophy (DMD) and exercise.~     Today it is unknown how exercising impacts boys with DMD. The investigators believe that~     increasing activity and aerobic exercise may help with heart, lung, and muscle function. The~     investigators are hoping to compare physical strength and blood samples of boys with DMD to~     see if there are any differences between kids who exercised more as a child versus those who~     didn't.~   "
18940|NCT03319017|"~     This study tries to find how hypoxia and hyperoxia, among types of the respiratory failure~     induced cell damage that can arise in the course of traumatic damage and treatment,~     influences apoptosis of PMN cells and IL-6 and tumor necrosis factor(TNF)-α as inflammatory~     cytokines.~   "
18943|NCT03318978|"~     Evaluation of the pharmacokinetics for [14C]-benzo[a]pyrene ([14C]-BaP) and metabolites in~     plasma and urine over 48 hours following 4 oral doses of 25, 50, 10 and 250 ng (2.7-27 nCi).~   "
18944|NCT03318965|"~     The objective of the present study was to compare the ability of acute physiology and chronic~     health evaluation (APACHE) scoring systems with the combination of an anthropometric variable~     score adductor pollicis muscle (APM) thickness to the APACHE systems in predicting~     mortality in the ICU. Three hundred and four patients enrolled in this prospective~     observational study. The APM thickness in dominant hand and APACHE II and III scores were~     measured for each patient upon admission. Given scores for the APM thickness, were added to~     APACHE score systems to make two composite scores of APACHE II- APM and APACHE III- APM. The~     accuracy of the two composite models and APACHE II and III systems in predicting mortality of~     patients was compared using area under the ROC curve.~      Based on the study results, the area under the ROC curves improved in composite models.~     Therefore, it seemed that considering anthropometric variables may improve prediction of~     mortality in APACHE systems.~   "
18945|NCT03318952|"~     The purpose of this study is to compare the efficacy of two types of local anesthesia~     (articaine and lidocaine) for infiltration anesthesia during restorative dental procedures on~     lower teeth in pediatric patients. The patients will require similar dental operative~     procedures on both right and left sides of the mandible in order to qualify for this study.~     The study will require at least two dental appointments, where a randomized, cross-over study~     methodology will be utilized. All subjects will be treated by the same dentist. The comfort~     of the patient will be assessed at various points during the procedure using the Wong-Baker~     Faces Scale.~   "
18946|NCT03318939|"~     This is a Phase 2, open-label, multicenter study to evaluate the efficacy and the~     safety/tolerability of poziotinib in up to 174 patients with NSCLC exon 20 insertion~     mutations (87 patients with EGFR exon 20 insertion mutations and 87 patients with HER2 exon~     20 insertion mutations).~   "
18947|NCT03318926|"~     The objective of the this study was to examine the amount and duration of tea consumption in~     relation to the risk of renal stone disease.~   "
18948|NCT03318913|"~     Type 2 diabetes mellitus (T2DM) is a chronic metabolic disease of abnormal carbohydrate~     metabolism which is related with high morbidity and mortality rates caused by its~     complications. One of the major diabetes-related arterial phenotypes thought to be~     responsible for development of cardiovascular disease is endothelial dysfunction. Nitric~     oxide (NO) is a potent molecule derived of endothelium, which plays key role in control of~     vascular tone. In T2DM present endothelial dysfunction due to reduced NO bioavailability.~     Fish protein hydrolysates (FPH) have been showed to present antioxidant peptides (and high~     value of ACE inhibition activity. Therefore, the present study aimed to examine whether~     single dose of FPH ingestion would reversal macro- and microvascular endothelial dysfunction~     in T2DM.~   "
18949|NCT03318900|"~     The goal of this clinical research study is to find the highest tolerable dose of anti-CD137~     (utomilumab) that can be given in combination with CD8+T cells, IL-2 (aldesleukin), and~     cyclophosphamide in patients with ovarian cancer. The effect of this combination treatment~     will also be studied.~      This study is divided into 2 parts: leukapheresis and treatment. In the leukapheresis part,~     blood cells will be collected from you to be made into modified CD8+T cells and then they~     will be given back to you in the treatment part.~   "
18950|NCT03318887|"~     Sofosbuvir plus daclatasvir with or without ribavirin is one of the currently recommended~     treatment option for chronic hepatitis C. The objectives were to identify factors associated~     with sofosbuvir/daclatasvir plasma concentrations variations and to evaluate their impact on~     viral kinetics.~   "
18951|NCT03318874|"~     An open label, randomized controlled study in a Norwegian population with meibomian gland~     dysfunction. Patients will be randomized to one of two groups: THERA°PEARL Eye Mask (Bausch &~     Lomb Inc., New York, USA) or Blephasteam® (Spectrum Thea Pharmaceuticals LTD, Macclesfield,~     UK). All patients will receive Hylo-comod (URSAPHARM Arzneimittel GmbH, Saarbrücken,~     Germany).~   "
18952|NCT03318861|"~     To evaluate the safety and tolerability of KITE-585, an autologous engineered CAR T-cell~     product targeting a protein commonly found on myeloma cells called BCMA. Patients will be~     given a 3 day course of chemotherapy followed by a single infusion of KITE-585.~   "
18953|NCT03318848|"~     This study´s objective was to identify the effectiveness of bed bath video during simulation~     in the performance of undergraduate student skills. Method. This is a randomized, blinded~     clinical trial. The sample consisted of students of the second year of nursing graduation who~     were divided into two groups: intervention group (students who simulated bed bath using the~     video) and control group (students who simulated bed bath without the video). The primary end~     point was the performance of the students' abilities about bed bath procedure, which was~     evaluated in two moments (before and after the simulation) and we used a previously~     elaborated and validated checklist. Prior to the collection, the research project was~     submitted to the Research Ethics Committee and the data was collected after its approval.~   "
18954|NCT03318835|"~     The purpose of this study is to evaluate the efficacy of Thalidomide combined with~     R-CHOP(RT-CHOP) in newly diagnosed，untreated double-expressor Diffuse Large B-Cell Lymphoma~     patients (DLBCL)~   "
18955|NCT03318822|"~     The purpose of the study is to assess the usability and tolerability of this jugular vein~     compression device in a population of helmeted and non-helmeted competitive high school,~     collegiate and professional athletes in the sports of football and rugby. This study differs~     from previous work in that it is designed to capture additional data related to the athlete~     experience wearing the jugular vein compression device in older and more elite playing~     levels.~   "
18956|NCT03318809|"~     A study to assess the safety, tolerability, and pharmacokinetics of AMG 986 given orally as a~     single dose to healthy subjects and subjects with severely impaired kidney function.~   "
18957|NCT03318796|"~     TRYTON Post Approval Study (PAS) of the Tryton Side Branch Stent~   "
18958|NCT03318783|"~     Soluble epoxide hydrolase (sEH) is the metabolizing enzyme of epoxyeicosatrienoic acids~     (EETs), which may play a role in reducing neuroinflammation and regulating cerebral blood~     flow after subarachnoid hemorrhage (SAH). Hypotheses: Pharmacologic inhibition of the sEH~     enzyme is safe and will result in increased EETs availability in the blood and cerebrospinal~     fluid. This study is a double-blind, placebo-controlled, phase 1b randomized trial to~     evaluate the safety and efficacy of GSK2256294, a novel soluble epoxide hydrolase inhibitor~     in patients with aneurysmal SAH.~   "
18960|NCT03318757|"~     This research is being done to determine quantitative and qualitative differences in~     patients' post-operative pain levels following elective orthognathic surgery after the local~     administration of a liposomal bupivacaine injection.~      A primary objective is to determine whether using a liposomal bupivacaine injection placed~     locally at the conclusion of elective orthognathic surgery will decrease pain levels (as~     determined by VAS scores). A secondary objective is to examine whether using a long acting~     liposomal bupivacaine injection locally at the conclusion of elective orthognathic surgery~     leads to decreased use of narcotics post-operatively.~   "
18961|NCT03318744|"~     Silent brain infarction (SBI) or incidental infarct is common. Recent studies revealed~     individuals with SBI have an increased risk of future stroke. Even though the 2014 AHA/ASA~     recommendation for ischemic stroke and transient ischemic attack considered SBI as an entry~     point for secondary prevention, convincing evidence with regard to the preventive efficacy of~     antiplatelet therapy against incident stroke in SBI is scant. Investigators examine if~     antiplatelet therapy can effectively decrease the incidence of future stroke in SBI~     individuals.~   "
18962|NCT03318731|"~     This is a randomized, repeated measures and double blind study which measures the effect of~     fenugreek extract on markers of muscle damage and inflammation in non-resistance trained~     males. Participants will complete baseline testing and then be randomized into groups.~     Participants will complete a 2 week, split-body resistance training program. They will then~     return for testing in which they will complete an overreaching protocol for 5 consecutive~     days. Measurements will be recorded 24 hrs after the fifth day. Participants will resume the~     training program for one additional week and return for final measurements.~   "
18963|NCT03318718|"~     During anesthesia, neuromuscular blocking agents (NMBA) are routinely used for relaxation of~     muscles necessary for the conduction of the surgical procedure. Train-of-four (TOF) test is~     based on supramaximal stimulation of peripheral nerve resulting in four twitches: T1 to T4.~     The assessment of the NMBA blockade is performed routinely by measurement of the amplitude of~     compound muscle action potential (CMAP) and calculation of percentage of CMAP decrement from~     T1 to T4.~      Train-of-four monitoring is routinely performed during spine surgery by stimulation of the~     ulnar nerve. Furthermore motor evoked potentials (MEPs) are routinely used in intraoperative~     neuromonitoring to assess the whole motor pathway from the cortical level down to the distal~     muscle. During anesthesia MEPs are routinely evoked by transcranial electrical stimulation~     with single or short train stimuli. In clinical practice even though full muscle relaxation~     of the hand by NMBA can be observed, utilizing the TOF test, remaining muscle tonus can be~     observed at the paraspinal musculature during spine surgery.~      The goals of this study are to determine (1) if any differences between muscle relaxation of~     the hand and foot (measured by TOF test and MEPs) and MEPs of the paraspinal musculature~     occur; (2) how much more NMBA must be administered to achieve full muscle relaxation of the~     paraspinal musculature in comparison to the hand or foot.~   "
18964|NCT03318705|"~     The investigators would like to know if different imaging devices can improve the quality of~     images and visualization of imaged tissues. Also, the investigators would like to find out~     whether these changes are useful in the diagnosis and treatment of eye diseases. Using images~     of previous participants will allow us to demonstrate the advancement of different~     technologies, as well be used to allow comparisons between current technologies.~   "
18965|NCT03318692|"~     The clinically already tested and approved MySpine system is compared to the free-hand dorsal~     instrumentation, which is the gold standard in spondylodesis surgery. The aim of this study~     is to investigate whether or not the pedicle screw can be inserted anatomically more~     accurately by the MySpine system than by the conventional free-hand method using~     intraoperative fluoroscopy.~   "
18966|NCT03318679|"~     Hyperglycemia is present in 50 percent of patients with acute ischemic stroke. Patients with~     hyperglycemia have higher in hospital, 30 and 90 day mortality and morbidity. Sixty percent~     of these patients have some form of diabetic syndrome, known or unknown. Remaining 40% of~     patients are not diabetic. Contrary to logic patients with non diabetic hyperglycemia (NDH)~     have statistically higher morbidity and mortality compared to the diabetic hyperglycemia (DH)~     cohort. So far multiple treatment trials (THIS, GRASP, GIST-UK, SHINE ongoing) with differing~     treatment goals have shown no clear benefit, however no obvious distinction was made along~     the diabetic and non-diabetic hyperglycemic groups.~      If hyperglycemia in the acute phase was the only culprit in worsening the injury, then there~     should be no difference in the outcomes for DH and NDH. Existing data implies that the two~     categories are two distinct physiological entities that are thus not amenable to same~     treatment. Stating it simply NDH is not an insulin deficient state where as DH is.~      Alternative possibility is that body and Neurons are accustomed to high sugars in diabetics~     and thus can tolerate higher sugars better during ischemic stroke compared to non diabetics.~      The overarching hypothesis is that reducing blood sugars in NDH increases stroke volume and~     thus consequently worsens outcome.~   "
18967|NCT03318666|"~     The purpose of this pilot study is to provide preliminary findings testing the Supporting Our~     Valued Adolescents (SOVA) intervention, two social media sites (one for adolescents, one for~     parents) aiming to address negative health beliefs, knowledge about depression or anxiety,~     parent-adolescent communication, in a moderated online peer community, with the goal of~     increasing adolescent use of mental health services.~   "
18968|NCT03318653|"~     The objective of the current study is to evaluate the compliance to blood pressure~     measurements' recommendations in dialysis centers.~      The idea is to address a questionnaire to physicians, head nurses and patients in order to~     probe the way to measure blood pressure. The objective is to face the theoretical guideline~     with what is effectively done.~   "
18979|NCT03318510|"~     Glaucoma is the second leading cause of blindness worldwide. Literature shows increasing~     evidence that dysfunction of ocular microcirculation in the optic nerve influences the~     progression of glaucoma. Laser speckle flowgraphy (LSFG) represents a non-invasive method to~     quantify ocular perfusion also at the ONH. LSFG enables noninvasive quantification of~     microcirculation of the optic disc in Japanese glaucoma patients~   "
18980|NCT03318497|"~     To assess if percentage change in 18F-FLT PET/CT quantitative parameters (SUV max, or SUV~     peak or proliferative tumor volume) after 2 cycles of neoadjuvant chemotherapy can predict~     overall survival at 1 and 2 years and progression free survival at 6 months and 1 year in~     patients with borderline resectable or locally advanced, pancreatic adenocarcinoma.~   "
18969|NCT03318640|"~     Mindfulness (innovative and integrative practice in care) allows the individual to adapt~     his/her behavior (physical and emotional), in a stressful environment, by regulating cardiac~     activity, especially the parasympathetic system. In schizophrenia, despite the positive~     effect of treatments on symptoms (delusions and hallucinations), patients have altered~     markers of the parasympathetic (high frequency, HF) system. The investigator propose a~     session of Mindfulness Based Stress Reduction (MBSR) for patients suffering from~     schizophrenia in order to measure the impact on the parasympathetic system (HF),~     self-awareness (being well in one's body and being aware of their own actions; EASE) and~     cognition (attention) in relation to the management of conflicts or emotions. The study~     compare with patients who receive a session of techniques based on the management of emotions~     and social cognition (cinemotion, Michael's Game and Tom Remed).~   "
18970|NCT03318627|"~     Relevant problems of rotator cuff repair:~        -  High retear rate after rotator cuff repair of 13%, despite regard of the criteria for~          reparability of a tear.~        -  Long and exhausting rehabilitation after rotator cuff repair with an abduction splint~          for six weeks.~      Hypothesis:~      The investigators believe that high tension repair has a higher retear rate than low tension~     repair, regardless of the tear size. The investigators also believe that abduction of the arm~     can reduce relevant tension on the repair. But not each repair benefits equally from this.~      Relevance of this hypothesis:~      The ingenious advantage of this new parameter (intraoperative repair tension) is, that it can~     be influenced. In future, if this hypothesis would be true, the repair tension could be~     reduced intraoperative by release, side-to-side (margin convergence) repair or medialization~     of the footprint and thereby convert a high risk to a low risk tension repair.~      Moreover, it could be that patients with a low tension repair does not necessarily have to~     wear an abduction splint. And on the other hand, high tension repair patients should probably~     wear the abduction splint longer with gradually reduction.~      Approach:~      The present research plan focused on a new intraoperative (arthroscopic) determinable~     parameter (repair tension on footprint in 0° and 40° abduction) to determine the risk of~     recurrence after tendon repair in rotator cuff tears, which are pre- and intraoperative~     defined as reparable. Therefore, the tension of the repaired tendon is measured~     intraoperative with a spring balance (newtonmeter) and correlated with the postoperative~     retear-rate.~      • Measure intraoperative repair tension with the arm in 0° and 40° of abduction~   "
18971|NCT03318614|"~     A 3-month study was conducted in flood victims from affected villages in the Tumpat district,~     Kelantan. Participants were given either probiotic, Bifidobacterium infantis M63 (M-63 group)~     or no probiotics (control group) for three months. At baseline and 3-month, participants were~     assessed for thewater, sanitation and hygiene (WaSH) practices, abdominal symptoms, breath~     testing for hydrogen and methane to detect the presence of SIBO and also fecal samples for~     gut microbiota profiling.~   "
18972|NCT03318601|"~     Copeptin is a glycopeptide released by the post-pituitary gland. In case of decrease in blood~     volume or blood pressure, it is secreted in the serum in an equimolar quantity to arginine~     vasopressin (AVP) . Unlike AVP, copeptin is readily assayable in serum and its prognostic~     value has been recently observed during cirrhosis. However, the pathophysiological~     relationships between serum copeptin concentrations and indirect markers of inflammation are~     unknown.~      The main objective of this multicenter pilot study is to study the relationship between serum~     copeptin and markers of inflammatory stress in cirrhotic patients with ascites. It is indeed~     in this population with high-risk of complications that most need biomarkers of events (like~     death) are needed. The main secondary objective is to evaluate the prognostic interest at 6~     months of the variation of copeptin between day 0- day15.~   "
18973|NCT03318588|"~     Photoreceptor apoptosis is the basis for permanent visual loss in a number of retinal~     disorders including age-related macular degeneration (AMD) and retinal detachment (RD). Thus,~     despite tremendous advances in vitreoretinal surgery and management of rhegmatogenous RD~     leading to a primary reattachment rate over 95%, some patients show poor visual recovery~     because of photoreceptor apoptosis.~      Physiologically, microglial cells (resident macrophages) are present only in the inner~     retina. The subretinal space, located between the retinal pigment epithelium (RPE) and the~     photoreceptor outer segments (POS), is devoid of all mononuclear phagocytes and form a zone~     of immune privilege. In AMD, several studies showed a strong association between subretinal~     mononuclear phagocytes infiltration and advanced forms of AMD. Experimental work in mice~     suggest that this infiltration plays an important role in the pathogenesis of this condition~     by producing inflammatory cytokines.~      RD-induced photoreceptor apoptosis might result from similar mechanisms. The aim of this~     study is to determine the cytokine profile in vitreous samples from patients with RD and to~     compare it with those from control patients with macular hole.~   "
18974|NCT03318575|"~     The purpose of the study is to evaluate the hypothesis that patients receiving remote~     ischemic conditioning using the autoRIC device show statistically significant reduction in~     the prevalence of ischemia-reperfusion injury to the myocardium as compared to patients in~     the autoRIC Sham device arm (within 12-24 hours post-elective PCI procedure).~   "
18975|NCT03318562|"~     This study will evaluate the pharmacodynamic (PD), safety, antitumor activity, and PK of~     eFT508 in female subjects who have pathologically documented, radiographically measurable,~     metastatic or locally advanced and unresectable TNBC and have received prior cancer therapy~     regimen for metastatic disease, and in male and female subjects who have histologically or~     cytologically confirmed advanced HCC not amenable to surgical resection and have failed~     systemic therapy.~   "
18976|NCT03318549|"~     Better understand the impact of visual impairment on daily task performance in patients with~     eye diseases of the visual pathways, such as glaucoma and age-related macular degeneration~     (AMD).~      Longitudinal study, with biannual visits, including patients with: glaucoma, suspected of~     having glaucoma, non-glaucomatous optic neuropathies, AMD, retinal degenerations, other~     diseases involving the visual pathways, besides healthy controls. Subjects will perform~     standard ophthalmological exams, and the following research tests: psychophysical, eye~     tracking, electroencephalogram, driving simulator, virtual reality, balance assessment, and~     questionnaires.~   "
18977|NCT03318536|"~     The aim of the present study is to quantify the dose and usage of sympathomimetics used in~     caesarean section.~   "
18982|NCT03318471|"~     Use of Mayfield skull clamp during craniotomies; results in a sharp and intense noxious~     stimulus which results in a severe hemodynamic pressor response. Many strategies have been~     reported to blunt this undesirable pressor effect. This prospective, double blind, and~     randomized study is the first to evaluate the effect of MgSo4 on attenuation of hemodynamic~     pressor activity after head clamp application during craniotomies.~   "
18983|NCT03318458|"~     To analyze the effects of a Pilates exercise program in Spanish postmenopausal women with~     Fibromyalgia~   "
18984|NCT03318445|"~     This is an open label, non-randomized, dose escalation and expansion Phase Ib trial to~     evaluate the safety and recommended phase II dose of the combination of irinotecan and~     rucaparib.~   "
18985|NCT03318432|"~     The Stroke Recovery Initiative is a nation-wide participant recruitment registry that~     connects people who have had a stroke with researchers who are working to develop new~     approaches to improve recovery after stroke.~   "
18986|NCT03318419|"~     The vast majority of patients with ALL will die of the disease, and no standard chemotherapy~     regimen were defined for patients with relapsed/refractory ALL.Our previous experience has~     shown that Cladribine in combination of GAP (G-CSF priming, low dose cytarabine, and~     Pegaspargase) are effective with tolerable toxicity profiling.Thus, this phase 2 clincial~     trial is going to evaluate the efficacy and safety of cladribine in combination with G-CSF,~     low-dose cytarabine and Pegaspargase (C-GAP) in patients with refractory/relapsed acute~     Lymphoblastic Leukemia~   "
18987|NCT03318406|"~     Bronchoscopic thermal vapor ablation using Uptake Medical Technology Inc.'s InterVapor System~     is indicated for treatment of patients with heterogeneous upper lobe emphysema. This study is~     a retrospective and prospective, observational, multi-center, post-market registry of~     patients prescribed InterVapor. The primary objective of the Registry is to describe the~     long-term impact of InterVapor treatment on patient quality of life (QOL) in a real-world~     setting. After InterVapor treatment, patients will be followed for 5 years as per the~     standard of care and safety and efficacy data (quality of life, pulmonary function, exercise~     capacity) collected as part of the registry.~   "
18988|NCT03318393|"~     The investigators will prospectively enroll 30 neonatal and pediatric ECMO patients at a~     single pediatric Level 1 trauma center. The patients will be randomized into two arms; one~     arm will receive unfractionated heparin and the other arm will receive bivalirudin. There~     will be 15 patients in each arm for a total of 30 patients.~      Primary aim will be to compare the efficacy of bivalirudin to unfractionated heparin.~   "
18989|NCT03318380|"~     This clinical trial studies how well contrast-enhanced ultrasound imaging works in diagnosing~     liver cancer in patients with cirrhosis. Diagnostic procedures, such as contrast-enhanced~     ultrasound imaging, may help find and diagnose liver cancer.~   "
18990|NCT03318367|"~     This pilot clinical trial studies a virtual reality education module in reducing anxiety and~     increasing knowledge in patients with prostate cancer undergoing radiation therapy. A virtual~     reality education module may be useful in helping patients understand what they can expect to~     happen during their radiation treatments and help reduce stress relating to the radiation~     treatments.~   "
18991|NCT03318354|"~     Subjects to compare the single dose bioavailability of Torrent's Olmesartan Medoxomil Tablets~     40 mg and Benicar 40 mg Tablets of Daichi Sankyo Inc. USA. Dosing periods of studies were~     separated by a washout period of 7 days.~   "
18992|NCT03318341|"~     This project aims to test a new technology that may improve hand function impaired from a~     stroke, thereby improving independence and quality of life.~   "
18993|NCT03318328|"~     A survey of adults and parents of children with cystic fibrosis on food insecurity~   "
18994|NCT03318315|"~     This is a randomized, un-blinded, Phase II study in males and non-pregnant females, who are~     in good health, 19 to 64 years of age. This study is designed to assess the safety,~     reactogenicity, and immunogenicity of a pre-pandemic AS03 (GSK) adjuvanted 2017 monovalent~     inactivated influenza A/H7N9 vaccine, when two doses are administered 21 days apart either~     sequentially or simultaneously (within 15 minutes) with licensed seasonal influenza vaccine.~     Subjects will be randomized into one of three treatment groups. The study will enroll~     approximately 150 individuals who have no history of influenza A/H7N9 infection or prior~     receipt of an influenza virus H7 subtype vaccine. Study duration is approximately 16 months~     with subject participation duration of approximately 13 months. The primary objectives of~     this study are: 1) to assess the safety and reactogenicity following sequential or~     simultaneous IM administration of 2 doses of AS03-adjuvanted 2017 H7N9 IIV and one dose of~     seasonal influenza vaccine (IIV4); 2) to assess the serum HAI and Neut antibody responses~     against A/H7N9 at approximately 21 days following receipt of two doses of AS03-adjuvanted~     2017 H7N9 IIV administered IM approximately 21 days apart; 3) to assess the serum HAI and~     Neut antibody responses against the seasonal influenza strains at approximately 21 days~     following receipt of IIV4.~   "
18995|NCT03318302|"~     The aims of this survey are to assess the relationships between exposure to screens of~     digital media devices, sleep patterns, and daily function such as subjective sleepiness and~     attention abilities in adult Israel population~   "
18996|NCT03318289|"~     Objectives: To evaluate the effects of a Ving Tsun (VT) reactive balance training programme~     on reactive balance control, muscle strength, balance confidence and falls in~     community-dwelling older adults.~      Hypothesis: The VT group subjects will have improved post-training reactive balance control,~     muscle strength, balance confidence and fall incidence outcomes than the active controls.~      Design and subjects: In this prospective, randomised, single-blinded controlled trial,~     approximately 114 healthy seniors (55-70 years old) will be randomly assigned to either the~     VT group (n~57) or control group (n~57). Interventions: Subjects in the VT group will receive~     VT reactive balance training (3 hours/week) for 3 months, whereas subjects in the control~     group will receive no VT training but will jog 3 hours/week during the intervention period.~      Study instruments and outcomes: Primary outcome measures: reactive balance control, as~     indicated by lower extremity muscle activation onset latency; hip and ankle strategies and~     centre of pressure movements will be measured by electromyography, electrogoniometry and a~     force platform, respectively. Secondary outcome measures: knee muscle strength, balance~     confidence and fall history will be assessed by an isokinetic dynamometer,~     Activities-specific Balance Confidence Scale (Chinese) and interviews, respectively (pre-,~     post- and follow-up measurements).~      Data analysis: Data will be analysed using repeated-measures analysis of (co)variance~     followed by post-hoc tests, as appropriate (alpha = 0.05).~   "
18997|NCT03318276|"~     Rinexin® Tab (Cilostazol 100mg, Ginkgo biloba leaf extract 80mg) has been widely used as an~     anti-platelet agent for the treatment of PAD. SID142 is a new controlled-release product~     improved patient's convenience and disadvantage of dosage regimen of previous drug. The aim~     of this study was to compare the efficacy and safety of SID142 and Rinexin® Tab in patients~     with PAD~   "
18998|NCT03318263|"~     The estrogen-dependent nature of breast cancer was first reported in 1896 with the~     publication of George Beatson's observations on the regression of breast cancer following~     oophorectomy. Endocrine therapy, targeting ER either directly by selective estrogen receptor~     modulators (SERMs) and pure antagonists or indirectly by aromatase inhibitors (AIs) that~     block estrogen production, remains the mainstay of treatment of hormone-sensitive breast~     cancer in the adjuvant and metastatic settings.~      Intrinsic (de novo) and acquired endocrine resistance constitutes an important clinical~     challenge in the treatment of breast cancer and multiple mechanisms are suspected to underlie~     the emergence of endocrine resistance.~      The role of the estrogen receptor (ER), encoded by the ESR1 gene, in normal mammary gland~     development and the progression of breast cancer is well established. ESR1 mutations,~     occurring in 10 to 30% of ER-positive metastatic breast cancer resistant to AIs, lead to~     ligand-independent activation of the ER.~      For patients treated with AIs, monitoring of circulating tumour DNA (ctDNA) for ESR1, PIK3CA~     and AKT1 mutations could permit early detection of resistance to AIs as recently reported~     during 2016 American Society of Clinical Oncology (ASCO) meeting.~   "
18999|NCT03318250|"~     This a single center study comparing two forms of electrical stimulation: sub-sensory burst~     stimulation (DRG-Burst3D) and standard low frequency stimulation (DRG-LF) in the dorsal root~     ganglion of subjects diagnosed with neuropathic pain~   "
19000|NCT03318237|"~     Epilepsy affects a significant number of children in the United States. The majority of~     patients achieve control of their seizures by conventional treatment strategies including~     medications. However, one third of patients do not achieve satisfactory seizure control with~     medications alone. Ketogenic diet and lifestyle modifications may also be tried. In some of~     these children, the seizure focus can be localized to one area of the brain and the seizures~     are resistant to conservative treatment strategies. These children may have subtle~     structural/developmental abnormalities in their brain, the most frequent of which is focal~     cortical dysplasia. These are localized areas of abnormal lamination of the cerebral cortex~     that can be extremely subtle and difficult to detect, even with state of the art magnetic~     resonance imaging (MRI). More importantly, these lesions may be amenable to surgical~     resection resulting in marked decrease in frequency or even resolution of seizures.~      MRI is a noninvasive imaging modality without ionizing radiation that has played a central~     role in the assessment of anatomy, physiology/pathophysiology of children with epilepsy. It~     is particularly useful in children with refractory focal epilepsy. Prior studies have shown~     that high resolution, high-field (3T) MR imaging of the brain helps to identify subtle focal~     epileptogenic abnormalities, including focal cortical dysplasia, in some patients. However,~     there is scarce data directly comparing the performance of ultra high-field (7T) MRI,~     currently an investigative technique offering optimized contrast and signal-to-noise rations~     and superior spatial resolution, with clinically available 3T MR imaging.~      The purpose of this study is to evaluate whether ultra high-field (7T) MR imaging improves~     detection and characterization of subtle structural epileptogenic abnormalities in children~     with focal epilepsy.~      The importance of this research is that identification of a focal epileptogenic lesion in~     children with refractory epilepsy has fundamental management implications, as surgical~     removal of such lesion may dramatically improve outcomes and the chance of seizure freedom.~   "
19001|NCT03318224|"~     Fatigue is a major concern during and after cancer therapy with severe impact on quality of~     life. Yet, sound comparable data on fatigue prevalence, severity, and impact on daily life~     across different tumor entities is lacking. Furthermore, little is known about the current~     state of screening, counselling and treatment of fatigue.~      Thus, the FiX-Study aims to assess such data to identify patient groups with especial need~     for an improved fatigue management and treatment.~      A minimum of n=3000 patients about equally distributed about the 16 most common tumor~     entities shall be recruited between year 1 and 2 after primary cancer diagnosis via the~     cancer registry Baden-Württemberg. Data on fatigue (EORTC QLQ-FA12, BFI), quality of life~     (EORTC QLQ-C30), depression and anxiety (PAQ-4), and information about screening and~     treatment of fatigue will be assessed via self-reported questionnaires. Clinical data~     regarding tumor and treatment characteristics will be derived from the cancer registry.~      This trial is imbedded in a larger research agenda on fatigue and will provide the basis for~     the development of an individually-tailored fatigue program.~   "
19002|NCT03318211|"~     All women with severe preeclmapsia were given a loading dose of 4 g magnesium sulfate IV~     followed by the maintenance dose of 1 g/h infusion till the delivery. After delivery, women~     who received magnesium sulfate for 8 hours or more were randomly divided into two groups:~      Group I ( 50 cases) No magnesium sulfate received postpartum and Group II ( 50~     cases)—magnesium sulfate infusion is given for conventional 24 h postpartum at a rate of 1 gm~     per hour~   "
19003|NCT03318198|"~     Randomized cross over trial investigating the effect of intensive attending supervision of~     residents caring for inpatients on the medical service on both patient safety and educational~     outcomes. Hypothesis: increased attending supervision would improve patient safety and~     resident education.~   "
19004|NCT03318185|"~     This project aims to investigate the safety and effectiveness of gasless single-port~     laparoscopic-assisted radical resection (GSLR) in the treatment of rectal carcinoma.~   "
19005|NCT03318172|"~     The purpose of this study is to explore which mode is effective in the management of~     intractable chronic pain, the high-density stimulation or the conventional stimulation, in~     patients who undergo SCS implantation after successful pre-implantation SCS trial.~   "
19006|NCT03318159|"~     To investigate the efficacy of posaconazole as prophylaxis antifungal agent in aplastic~     anemia / hypoplastic myelodysplastic syndrome (AA/hMDS) patients undergoing antithymocyte~     globulin (ATG) treatment~   "
19007|NCT03318146|"~     Glaucoma is the most frequent cause of irreversible & preventable blindness worldwide,~     affecting about 2% of the world's population in people over 40. The major risk factor, and~     only treatable factor in glaucoma, is increased intraocular pressure (IOP). IOP reduction can~     slow or arrest the progression of vision loss.~      Current treatment consists of drops administered on a daily basis with unfortunately low~     patient compliance, increasing the chance of blindness.~      Eximore's product aims to eliminate the need to apply eye drops on a daily basis and thus~     solves the significant problem of patient compliance.~   "
19017|NCT03318016|"~     Determine the maximum tolerated dose (MTD) and toxicity profile of the combination of~     cyclophosphamide and ATO (Arsenic Trioxide) in subjects with relapsed refractory AML.~      Determine the efficacy of ATO and cyclophosphamide in this population, as defined by response~     rate, response duration, event-free survival (EFS) and overall survival (OS).~      Determine the number of transplant-eligible subjects who are successfully bridged to stem~     cell transplantation or donor lymphocyte infusion.~   "
19008|NCT03318133|"~     Hip fracture is a global public health problem. The postoperative mortality and disability~     rate of hip fracture is high, and early surgery is still the most effective treatment method,~     but these patients are often associated with concurrent heart and lung and other organ~     dysfunction, anesthesia and surgery are extremely risky, mainly associated with high~     incidence of complications in the pulmonary and cardiovascular system, and anesthesia plays a~     vital role in ensuring that these patients can safely and effectively get through the~     perioperative period.~      The research on the relationship between anesthetic methods and hip fracture surgery~     prognosis mainly focuses on comparison between neuraxial anesthesia (including spinal~     anesthesia and epidural anesthesia) and general anesthesia with endotracheal intubation until~     now. In addition to general anesthesia with endotracheal intubation and neuraxial anesthesia,~     ultrasound-guided lumbar plexus and sciatic nerve block has been widely used in hip fracture~     surgery in recent years, especially for some high-risk patients with cardiopulmonary~     dysfunction. However, it is not clear whether ultrasound-guided combined lumbar plexus and~     sacral plexus block with sedative anesthesia can improve the prognosis of elderly patients~     with hip fracture, and in this study, we plan to make a prospective, multicenter, randomized~     controlled clinical trial to compare the effects of general anesthesia with endotracheal~     intubation and ultrasound-guided combined lumbar plexus and sacral plexus block with sedative~     anesthesia on the prognosis of elderly patients with hip fracture to clarify the clinical~     value of combined lumbar plexus and sacral plexus block with sedative anesthesia in elderly~     patients with hip fracture.~   "
19009|NCT03318120|"~     The purpose of this research study is to investigate how the brain and motor behavior changes~     in individuals with dystonia and other involuntary movement disorders and healthy individuals~     over time with exercise training.~   "
19010|NCT03318107|"~     The investigators have developed co-registered transvaginal photoacoustic and ultrasound (US)~     imaging techniques that allow them to visualize ovarian tumor structure and functional~     changes simultaneously, which may potentially reveal early tumor angiogenesis development or~     residual tumors after systemic treatment that is not available by US alone. The ability to~     detect early angiogenesis changes, as well as tumor morphology changes using a non-invasive~     imaging modality will greatly enhance the care for patients. The investigators plan to~     explore these techniques in monitoring cervical cancer treatment response and conduct pilot~     feasibility studies.~   "
19011|NCT03318094|"~     The purpose of this study is to better understand the contribution of sympathetic~     vasoconstriction to impaired insulin-mediated vasodilation and subsequently insulin-mediated~     glucose uptake. The investigators will test the hypothesis that removal of sympathetic~     vasoconstriction can result in improvement in insulin-mediated vasodilation and subsequently~     sensitivity to insulin-mediated glucose uptake.~   "
19012|NCT03318081|"~     The computerized cognitive rehabilitation therapy will be used to treat amphetamine-type~     stimulant (ATS) addiction.~   "
19013|NCT03318068|"~     LAY SUMMARY:~      The diagnosis and treatment of pediatric cancer is a significant stressor for adolescents and~     their families . Although most adolescents cope well with their cancer diagnosis, many~     experience emotional distress. A small proportion of those diagnosed with cancer will~     experience more intense mental distress, such as depression, anxiety, or anger. The practice~     of yoga may be a possible way of treating the negative emotional symptoms experienced by~     these adolescents. Previous studies suggest that yoga may improve anxiety, mood and~     psychological distress in adults with cancer. The results of two recent pediatric pilot~     studies show that yoga programs improved quality of life for adolescents receiving cancer~     treatment. Given this, we wish to examine the feasibility of offering a 10-week yoga program~     for adolescents who are receiving outpatient chemotherapy. This program includes both~     one-on-one in-person sessions and home-based sessions offered using SkypeTM. To assess this~     program, we will monitor patients' attendance, ask their opinions of the program and evaluate~     whether yoga improved their mental well-being. This study represents an important step toward~     identifying possible treatments to improve patients' quality of life and emotional health.~   "
19014|NCT03318055|"~     The study is a prospective, observational study of adult, non-cardiac, non-obstetric,~     elective surgical patients conducted over a period of one week. This large-scale clinical~     audit aims to assess the incidence rates of anaemia and hyperglycaemia amongst elective~     surgical patients in the Western Cape. A study such as this is essential in the assessment of~     the incidence rates of abnormal fasting blood glucose levels and reduce the risk of~     perioperative complications for patients. Preoperative anaemia is a modifiable risk factor~     and should be identified early and treated appropriately to improve patient outcomes.~   "
19015|NCT03318042|"~     The objective of this study is to investigate the possible association between 60 SNPs~     related to obesity, metabolism and cardiovascular disease with BMI, intestinal microbiota and~     adherence to the Mediterranean diet in a cohort of children and adolescents from the~     southeast of Spain.~   "
19016|NCT03318029|"~     There is a consensus that vitamin D deficiency is a public health issue because of its~     implications in several diseases including, osteopenia, osteomalacia, heart disease, diabetes~     (type I and II), inflammatory diseases, multiple sclerosis and rheumatoid arthritis. Studies~     in sunny countries have shown that vitamin D deficiency is a common phenomenon, despite the~     abundance of sunlight in these places, which shows the influence of diet, skin pigmentation,~     cultural habits and also genetic factors on the metabolism of this vitamin. Thus, the study~     hypothesis is that vitamin D supplementation is required to obtain the optimal serum~     concentration in Brazilian people living both in Brazil and in the United Kingdom and that~     this response is dependent on the initial levels, being influenced by sunlight exposure, skin~     pigmentation, diet and polymorphisms of the vitamin D receptor gene. Two controlled,~     randomized, double-blind clinical trials were held (one in the UK and the other in Brazil)~     over a period of 12 weeks, with female subjects, Brazilian, aged 20 to 59 years. The women~     selected were divided into two groups: Placebo Group and Supplemented Group, the latter~     received vitamin D 600 IU. After the analysis of the effect of vitamin D supplementation~     compared to placebo, the investigators propose to analyse genome-wide transcriptomic~     expression in order to associate specific signal transduction and metabolic pathways to~     respective vitamin D responses. and a genetic risk score based on polymorphisms will be~     constructed. The 'systems level' approach will enable us to identify differences in gene~     expression and whether this explains why some individuals are 'good' responders or 'poor'~     responders to vitamin D supplementation. This is the first study that will examine two~     population groups of the same ethnic group and sex, living in different countries, with~     identical design studies. Our results first will determine how important supplementation and~     exposure to sunlight are for the serum level of vitamin D by comparing directly, using the~     same methodology, people living in different latitudes, as well as the genetic influence on~     the response to supplementation. The data will also provide both countries key data about the~     need to reconsider new revisions to dietary recommendations for vitamin D in adults.~   "
19018|NCT03318003|"~     The purpose of this study is to see whether the presence of night-time breathing disturbances~     (sleep-disordered breathing) in pregnant women is related to fetal growth patterns. The~     hypothesis is that fetal growth slows in the 3rd trimester in women with sleep-disordered~     breathing. Use of a nighttime breathing therapy called auto-PAP could minimize the slowing in~     fetal growth.~   "
19019|NCT03317990|"~     Prostate cancer is common but can commonly be cured with surgery, however, this often leads~     to a loss of erections, because the nerves controlling erections run in the outer coverings~     of the prostate. Nerve sparing, where the outer layers of the prostate are peeled off,~     increases post-operative potency, but also increases the risk of cancer being left behind and~     the need for radiotherapy, which renders the men impotent, even if they had nerve sparing~     surgery. A new technique called NeuroSAFE incorporates an additional safety check designed to~     promote nerve sparing without compromising cancer control. During surgery, a pathologist~     examines the prostate near the nerves to check for exposed cancer. If cancer is found, the~     nerve tissue is removed so the recurrence risk is similar to when cancer cells are not~     exposed. The investigators eventual aim is to perform a large scale RCT comparing NeuroSAFE~     with current UK practice (nerve sparing based on MRI scan, biopsy results and clinical~     examination). This application is to fund a feasibility study to ensure that men are prepared~     to be randomised within an RCT, and that the technique can be taught to other UK centres, so~     allowing participation in the multi-centre RCT. The investigators will gather data to allow~     us to plan the larger study by defining the primary outcome measure and powering the study~     based on the size and confidence interval of observed effects. This study is needed because~     with evidence supporting observation of low risk small cancers, a higher proportion of men~     undergoing surgery have capsular involvement. The investigators do not have a reliable way to~     detect cancer which has spread through the capsule of the prostate in whom nerve sparing~     would cause a positive surgical margin. The NeuroSAFE technique addresses this need and will~     only be available at participating centres through this trial.~   "
19020|NCT03317977|"~     The propose of the study is to test the effectiveness of Reach for Control (RFC) as compared~     to Michigan MATCH to improve asthma symptoms, asthma management and lung functioning and to~     decrease ED visits and admissions for youth with poorly controlled asthma when integrated~     into hospital emergency departments and delivered by community health workers. The study is a~     hybrid implementation-effectiveness design and will test RFC for use in real world, public~     healthcare settings.~   "
19021|NCT03317964|"~     The purpose of this study is to collect a saliva sample from patients with a pacemaker to~     study genes involved in cardiomyopathy, a condition where the heart muscle is abnormal.~   "
19022|NCT03317951|"~     Cardiovascular diseases are the number 1 cause of death globally and represent a major~     economic burden on health care systems. The investigators have developed a novel integrated~     care concept (NICC) which combines telemedicine with intensive support by a call center, an~     integrated care network including in- and outpatient care providers and guideline therapy for~     patients with heart failure (HF), atrial fibrillation (AF) or therapy resistant hypertension~     (TRH). The aim of the study is to show that NICC is preferable over guideline therapy alone.~     The investigators aim at including approximately 2930 patients who are either inpatients or~     referred to the outpatient clinic of the participating hospitals by their treating physician.~     The study will thus inform care providers whether quality of care can be improved by an~     integrated care concept providing telemedicine through a 24/7 call center approach.~   "
19023|NCT03317938|"~     Defecatory disorders like chronic constipation and faecal incontinence affect 25% of the~     population with rising incidence. Defecatory disorders pose a major health care burden and~     are poorly recognized and treated. The need for better diagnostics and therapeutics is~     substantial. Currently management options for these patients are limited, partly due to the~     fact that control of defaecation and continence is multifactorial but also due to the fact~     that it is difficult to identify the exact cause of patients' incontinence.~      Current assessment of patients with constipation and faecal incontinence include endoscopic~     assessment to rule out intraluminal organic cause for patients' symptoms, endoanal ultrasound~     scan / MRI to assess patients' pelvic floor anatomy and anorectal manometry to assess~     anorectal function. All tests are susceptible to measurement artifacts, with a high~     inter-individual variation with significant overlap between healthy asymptomatic and~     symptomatic patients.~      Endoluminal Functional Lumen Imaging Probe (EndoFLIP©) is a novel technology, originally used~     to measure the dimensions and function of a hollow organ. The proposed study intends to use a~     modified EndoFLIP to integrate several technologies into one which will save time and reduce~     test variability. A major difference from previous EndoFLIP studies are that the device will~     be defecated rather than providing static data from one location in the anal canal.~      In the proposed studies investigators will assess defecatory function in subgroups of Hong~     Kong patients suffering from chronic constipation and faecal incontinence and determine~     biomarkers to increase the diagnostic value of anorectal testing. Investigators will study up~     to 70 patients with anorectal disorders and 40 healthy control subjects. Investigators~     anticipate to improve diagnostics of anorectal disorders considerably.~   "
19024|NCT03317925|"~     In pediatric kidney transplant patients, rejection, medication toxicity and ischemia cause~     early and chronic renal allograft injury, which reduces graft lifespan and patient survival.~     Early detection of injury would facilitate prevention and treatment. The gold standard~     surveillance biopsy has limitations including delayed discovery of injury. No noninvasive~     test identifies graft injury before it is clinically apparent. This project's goal is to~     develop a novel early marker of subclinical graft injury to facilitate prompt recognition and~     treatment.~   "
19025|NCT03317912|"~     The aim of this clinical trial is to study the effect of an intravenous infusion of lidocaïne~     in a multimodal analgesic protocol on the architecture sleep during the first postoperative~     night.~   "
19026|NCT03317899|"~     This randomized phase II trial studies how well stem cell transplant with or without~     tbo-filgrastim works in treating patients with multiple myeloma or non-Hodgkin lymphoma.~     Eliminating the use of tbo-filgrastim after transplant may still help maintain a similar time~     to discharge.~   "
19027|NCT03317886|"~     The aim of this study is to evaluate the advantage of mesenteric approach during~     pancreaticoduodenectomy (PD) for pancreatic ductal adenocarcinoma (PDAC). The design of this~     study is multicenter randomized clinical trial, comparing oncological and surgical outcomes~     between mesenteric approach and conventional approach during PD for PDAC.~   "
19055|NCT03317522|"~     This study investigates the associations between measured maternal lipids (Total cholesterol,~     LDL-cholesterol , triglycerides and high-density lipoprotein cholesterol) at 28 weeks'~     gestation and offspring adiposity at 5-7 years. This was examined in a large observational~     study based in Belfast, UK.~   "
19110|NCT03316807|"~     Uptake, adherence, and completion of vaccination among HIV-infected adults were low, and~     their immune function and immune response to hepatitis B vaccination were also suboptimal,~     indicating that the current practice of hepatitis B vaccination can't protect HIV-infected~     adults from HBV infection. And the persistence of immunity induced by hepatitis B vaccination~     remains a challenge.~      This is a randomized, open-label trial, conducted among HIV-infected adults with drug~     rehabilitation. This study will compare the immunogenicity, immune persistence, and safety of~     three intramuscular 20µg and 60µg recombinant hepatitis B vaccines at months 0, 1, and 6~     among HIV-infected adults.~   "
19028|NCT03317873|"~     Iron deficiency is considered the most common nutritional deficiency worldwide and affects~     children and women in both non-industrialized as well as industrialized countries. The main~     regulatory molecule of iron metabolism is hepcidin, a hormone produced in the liver that~     regulates intestinal iron absorption, placental transport, recycling of iron by macrophages~     and release from stores. The expression of hepcidin is regulated by many mediators, one of~     which is Matriptase-2 - a transmembrane protease. Complete loss of function leads to the rare~     disease iron-refractory iron deficiency anemia (IRIDA). Matriptase-2 is encoded by the gene~     TMPRSS6 and the single nucleotide polymorphism (SNP) rs855791 causes a non-synonymous~     substitution (V736A) that reduces the activity of the protease to inhibit hepcidin~     transcription. Genome wide association studies have identified the TMPRSS6 SNP rs855791 has a~     strong association with red blood cell and iron parameters in the general population.~      The objectives of the study is to measure oral iron absorption and systemic iron utilization~     into red blood cells (RBC) using oral isotopic labels in subjects homozygotes for common~     variants of the TMPRSS6 gene with the SNP rs855791 (A736V); AA vs. VV subjects.~      The aim is to conduct an iron absorption study in 80 Taiwanese women of reproductive age,~     non-pregnant, non-anemic, investigating the effect of the genetic variants of the SNP~     rs855791. The participants will be split in two groups of equal size; wild type AA vs.~     mutation VV. Iron absorption and systemic utilization will be assessed by two test meals~     containing stable isotopes of iron.The primary outcome of the trial is the oral iron~     absorption from a test meal as compared between the two genotypes AA vs. VV. Secondary~     outcomes are the comparison iron status markers between the two genotypes.~   "
19029|NCT03317860|"~     This study examines how to best assess and treat post-stroke neglect. This study will examine~     the preliminary effects of an innovative intervention (repetitive task-specific practice +~     transcranial direct current stimulation) for individuals with neglect. This study will also~     determine whether items from various neglect assessments can be combined to establish a more~     comprehensive neglect measure.~   "
19030|NCT03317847|"~     The aim of the study is to compare bromfenac to dexamethasone eye drops to control~     inflammation after cataract surgery. Inflammation in the anterior chamber of the eye will be~     measured by a Laser Flare Photometer (LFP).~   "
19031|NCT03317834|"~     The purpose of this study is to demonstrate superior accuracy with the Navio ™~     Robotic-assisted Surgical System in achieving desired post-operative mechanical alignment,~     compared to TKA procedures using standard instruments. An additional study purpose is to~     document clinical and patient-reported outcomes in subjects receiving TKA with the Navio ™~     system.~   "
19032|NCT03317821|"~     The primary objective of this study is to demonstrate the safety and efficacy of the PHIL®~     liquid in endovascular treatment of dural arteriovenous fistula.~   "
19033|NCT03317808|"~     This study evaluates the effect of heavy slow resistance exercise in comparioson with~     conventional exercise. Half of participants will complete the heavy slow resistance exercise,~     the other will complete the conventional exercise.~   "
19034|NCT03317795|"~     This is a randomized controlled trial (RCT) to assess the comparative effectiveness of~     Levonorgestrel Intrauterine System (LNG-IUS) to Tranexamic Acid (TA) for the treatment of~     heavy menstrual bleeding (HMB) in women with clinically-significant fibroids.~   "
19035|NCT03317782|"~     To evaluate and compare the NoL index variations after a painful physiotherapy exercise in~     patients with upper limb CRPS, before and after a stellate ganglion block.~   "
19036|NCT03317769|"~     This study is a validation study to evaluate the acceptability, feasibility and impact of a~     mobile psychosocial intervention to enhance social functioning in people with schizophrenia.~   "
19037|NCT03317756|"~     Pilot test the novel educational patient-directed intervention to demonstrate the feasibility~     of the novel educational approaches developed in improving patient's willingness to achieve~     remission or low disease activity in RA.~   "
19038|NCT03317743|"~     the purpose of this open-label, dose escalation-dose expansion, Phase 1 clinical trial is to~     evaluate the safety, pharmacokinetics and anti-tumor activity and determine the maximum~     tolerated dose (MTD) and recommended phase II dose (RP2D) of NOV140101 (IDX1197HCl).~   "
19039|NCT03317730|"~     To confirm the feasibility of studying Xtampza ER during radiotherapy (RT) for LAHNC as part~     of a prospective clinical trial.~   "
19040|NCT03317717|"~     This study will determine the pharmacodynamic and safety of MEDITOXIN® in healthy male~     volunteers.~   "
19041|NCT03317704|"~     This study investigates the relation between ion-handling (K+) and fatigue development during~     exercise. Before and after a 5-week period of high intensity interval training, performance~     and ion-handling is assessed in young adults. In addition, mitochondrial function is~     examined.~   "
19042|NCT03317691|"~     the algorithm of artificial intelligent to diagnose myocardial infarction through prior~     surgery Electrocardiogram was established. The accuracy of using artificial intelligent to~     diagnose acute ST-segment elevation myocardial infarction and judge criminal vascular was~     evaluated.~   "
19043|NCT03317678|"~     This study aims to assess the impact of a chronic dietary intervention (8 weeks) with~     probiotics, specifically Fermented Milk Product with Probiotic (FMPP), on the mood of~     individuals with Major Depressive Disorder (MDD) refractory to standard antidepressant~     therapy, and its association with changes in intestinal microbiota and markers of~     inflammation.~   "
19044|NCT03317665|"~     The purpose of this study is to assess the incidence of hernia recurrence with the use of~     biologic and prosthetic mesh in ventral hernia repair.~   "
19079|NCT03317210|"~     The investigators assess and compare the efficacy of anemia treatment in pregnant women with~     anemia of chronic disease with true iron deficiency and in women with iron deficiency anemia.~   "
19080|NCT03317197|"~     Steroid use could be considered for patients with weaker adrenal function among those with~     post-cardiac arrest (CA) return of spontaneous circulation (ROSC), according to the former~     study. This finding is consistent with the medical background of this present study. This~     study will be the first to investigate these additional drugs of injection and associated~     prognosis in cardiac arrest (CA) patients outside the hospital, providing significant basic~     data.~   "
22239|NCT03275948|"~     The purpose of the study is to investigate, in healthy middle age subjects, effects of whole~     grain rye on cognitive functions, mood, and cardiovasculair risk markers~   "
19045|NCT03317652|"~     The brain has a high energy demand and requires continuous blood flow. The blood flow to the~     brain appears to be unaffected by small changes in blood pressure, but brain blood flow may~     be reduced by a large reduction in blood pressure. Large reductions in blood pressure are~     common during anesthesia or bleeding. It is unclear, however, how a given reduction in blood~     pressure affects blood flow to the brain.~      In this study, medicine called sodium nitroprusside is used to dilate blood vessels and~     reduce blood pressure in twenty healthy young men. The study will evaluate whether blood flow~     to the brain is affected when sodium nitroprusside is used to induce a moderate and a large~     reduction in blood pressure. Blood flow to the brain is evaluated using ultrasound on the~     neck.~      During breathing, oxygen is inhaled and carbon dioxide is exhaled. Carbon dioxide increases~     brain blood flow whereby changes in respiration can affect the blood flow to the brain.~     Sodium nitroprusside causes mild hyperventilation, whereby more carbon dioxide is exhaled,~     which will contribute to a reduction in brain blood flow. Thus, the study will also evaluate~     how brain blood flow is affected by hyperventilation and by breathing a mix of air and carbon~     dioxide.~   "
19046|NCT03317639|"~     A cluster randomised controlled trial will be conducted, using hospital as randomisation~     unit. Hospitals in Zhejiang Province, China, will be randomised into two arms (1:1): an~     intervention arm and a control arm. Hospitals in the intervention arm will receive a~     multi-components intervention based on the Behaviour Change Wheel model, whereas hospitals in~     the control arm will receive no intervention and maintain existing care. The randomisation~     will be conducted after one-year baseline data collection. The following baseline data will~     be used for randomisation match: hospital classification, beds in stroke centre, thrombolysis~     patient number, and percentage of patients receiving thrombolysis within 60 minutes of stroke~     onset. Hospitals with no stroke centre or with <20 cases received thrombolysis per year will~     be excluded from the study. The primary outcome will be difference between intervention arm~     and control arm in the percentage of patients receiving thrombolysis within 60 minutes of~     stroke onset on the follow-up stage (post-intervention).~   "
19047|NCT03317626|"~     Epidural analgesia for childbirth may fail to provide adequate pain relief. At NYULMC, to~     maximize the likelihood that epidural analgesia will work well, the gravity flow technique is~     used when performing epidural procedures.~      The gravity flow technique is not well known, and is therefore used in only a few hospitals.~     The purpose of this study is to quantify the reliability of the gravity flow technique to~     accurately validate the position of the epidural needle tip when performing lumbar epidural~     analgesia in laboring women.~   "
19048|NCT03317613|"~     In the oncology area, neuropathic pains are relatively frequent and can be induced by~     surgery, radiotherapy, or chemotherapy. In usual practice, some units are using qutenza in~     order to reduce neuropathic pain even though using of this patch for a population of cancer~     patients has never been demonstrated so far in a prospective study. The present prospective~     study proposes to evaluate the qutenza efficacy in peripheric neuropathic pain in cancer~     patients.~   "
19049|NCT03317600|"~     Stump and phantom pain after amputation are common, but the responsible mechanisms are still~     not clarified. It has been suggested that phantom limb pain can be reduced by regional~     anaesthesia and in several recent studies, pain was reduced following intrathecal and~     intraforaminal blocks. In this study, the investigators want to investigate if spontaneous~     and evoked pain in amputees will be relieved by regional nerve blocks involving the damaged~     nerves.~   "
19050|NCT03317587|"~     The aims of the current study are: 1) to pilot a manualized intervention (INSPIRE - Inspiring~     Nutritious Selections and Positive Intentions Regarding Eating and Exercise) to determine~     feasibility and acceptability, and 2) to evaluate the preliminary effectiveness of INSPIRE on~     physical and psychological variables.~   "
19051|NCT03317574|"~     to determine the efficacy and safety of Meditoxin® in treatment of crow's feet line~   "
19052|NCT03317561|"~     It is estimated that > 200 million patients in the world undergo surgery each year of which~     approximately 10 million will suffer from a myocardial injury in the perioperative period.~     Mortality is high in patients with myocardial injury since it often goes undiagnosed and~     management is unclear. In contrast to myocardial infarction diagnosed in the emergency room~     (non-surgical patient) where treatment is well established today, patients suffering from a~     perioperative myocardial injury have a poorer outcome. Additionally, the patho-physiology of~     myocardial injury is unknown in the individual patient, non-invasive diagnostic tools are not~     widely available and treatment remains unknown.~      Most cases of myocardial injury in Non-cardiac surgery (MINS) are seen within the first 48-72~     h after surgery and a majority have no symptoms. Many patients developing MINS are < 65 years~     old and non-diabetics, an age group that usually does not have coronary artery disease. A~     elevated Troponin T (TnT) without symptoms or ECG changes, typically occurring in the~     perioperative period, is an independent predictor of 30-day mortality. Surgical trauma also~     causes an increase in several pro-inflammatory cytokines, which together with sympathetic~     over-activity and platelet activation, leads to a hyper-coagulant state, and in turn may~     cause coronary thrombosis. It is possible that some cases of MINS also result from oxygen~     supply-delivery mismatch. To our knowledge, no study has investigated the cause of MINS in~     patients presenting with increased TnT in the perioperative period. Our aim is therefore to~     investigate patients having MINS in order to better understand its aetiology and subsequently~     develop focused strategies to reduce risks.~   "
19053|NCT03317548|"~     The aim of this study was to compare the clinical outcomes between fresh embryo and frozen~     embryo transfer in in vitro fertilization (IVF). All frozen embryo was vitrified at~     pronuclear stage (2PN) and cultured to cleavage embryos for transfer.~      This is a retrospective study. All IVF cycles were included in this study and further divided~     into fresh and frozen embryo transfer groups. The collection data including: stimulation~     protocols, medicines, blood test results, pregnancy test and all clinical data. The primary~     outcome is pregnancy rate and secondary outcome is implantation rate.~   "
19054|NCT03317535|"~     There is few randomized controlled clinical to investigated the impact of anesthetic type on~     outcome in patients with acute ischemic stroke in posterior cerebral circulation. It is~     unknown whether the choice of anesthesia is impacted on the outcomes for these patients or~     not. The investigators will perform a randomized controlled pilot clinical trial of general~     anesthesia versus sedation to explore and find out a potential fact whether anesthetic type~     alters perioperative neurological function in patients with acute ischemic stroke in~     posterior cerebral circulation.~   "
19056|NCT03317509|"~     This study aims to assess the therapeutic role of rTMS on parkinson's patients with~     dysphagia. Thirty PD patients with dysphagia using UK bank criteria for PD will recruited~     from outpatient clinic in Assuit University. All patients were admitted at Neuropsychiatric~     Department, Assiut University Hospital/ Assiut, Egypt. Each patient fulfilled the inclusion~     criteria as spontaneous swallows should be identified clearly when patients cannot perform~     voluntary swallows using clinical examination test. The patients will be allocated randomly~     into two groups one of which will receive real sessions of high frequency rTMS (25 HZ), with~     intensity of 80% of resting motor threshold detected from the hand motor area, with total~     2000 pulses for each hemisphere for 10 consecutive sessions totally over period of 10 days~     with repeated booster session every month during the period of follow up among three months.~     The other will receive sham sessions. All subjects will be followed up by selected clinical~     rating scales at different intervals pre session, post 10 sessions, and after one, two and~     three months.~   "
19057|NCT03317496|"~     This is a Phase 1b/2, open label, multicenter, safety and clinical activity study of avelumab~     in combination with chemotherapy as first-line treatment of adult patients with locally~     advanced or metastatic solid tumors. Initially, avelumab will be evaluated in combination~     with pemetrexed and carboplatin in patients with advanced non-squamous non-small cell lung~     cancer (NSCLC) (Cohort A1) and in combination with gemcitabine and cisplatin in patients with~     cisplatin-eligible urothelial (bladder) cancer (UC) (Cohort A2). As more information is~     learned about other anti-cancer immunotherapy agents, in future portions of the study,~     avelumab may be combined with chemotherapy and other anti-cancer immunotherapy agents in~     patients with these same or different tumor types.~   "
19058|NCT03317483|"~     Introduction:The drug-eluting beads transarterial chemoembolization (DEB-TACE) is introduced~     to better improve efficacy and reduce the systemic toxicity in liver cancer patients on~     account of its higher intratumoral chemotherapeutic drug concentration and reduced drug~     infiltration into systemic circulation. This study aimed to investigate the efficacy, safety~     and prognostic factors of DEB-TACE treatment in Chinese patients with liver cancer.~      Hypothesis:DEB-TACE illustrates a better treatment response, progression free survival (PFS),~     overall survival (OS) and less common adverse events (AEs) in liver cancer patients.~      Objective: to investigate the efficacy, safety and prognostic factors of DEB-TACE treatment~     in Chinese patients with liver cancer.~   "
19059|NCT03317470|"~     The investigators aim to improve adherence to follow-up recommendations for an abnormal Pap~     and effectively reduce disparities in cervical cancer risk and disease among rural and~     low-income urban women.~   "
19060|NCT03317457|"~     The objective of the trial is to assess the efficacy of Durvalumab and Tremelimumab in~     comparison to doxorubicin in treatment-naïve Soft tissue sarcoma patients~   "
19061|NCT03317444|"~     This is a multicenter, double-blind, placebo-controlled, parallel-design study. The study~     will enroll approximately 210 adult male and female subjects with stage 3 or 4 chronic kidney~     disease and metabolic acidosis. The study dosing (TRC101 or placebo) will continue for 12~     weeks once daily.~      The maximum study duration is anticipated to be up to 16 weeks.~   "
19062|NCT03317431|"~     Dopamine(DA) is a common neurotransmitter that has been known to regulate behavior, movement,~     cardiovascular，endocrine and gastrointestinal functions, but also functions as an important~     molecule engaging in the immune systems to possess anti-inflammatory effects. However, its~     role in ventilator-induced lung injury (VILI) is still unclear. Herein, this study aimed to~     investigate the therapeutic efficacy of dopamine on ventilation-induced lung endothelial~     barrier dysfunction and explore the possible underlying molecular mechanisms.~   "
19063|NCT03317418|"~     The aim of this study is to examine the variability of culture media composition based on the~     ATR-FTIR (Attenuated Total Reflectance-Fourier Transform Infrared Spectroscopy) technique on~     the day of embryo transfer/vitrification. In addition, the study will explore whether~     variations detected in the culture medium can be linked to embryo quality and the chances of~     achieving pregnancy.~   "
19064|NCT03317405|"~     This randomized phase I trial studies the side effects and best dose of Z-endoxifen~     hydrochloride in treating participants who are undergoing breast surgery. Z-endoxifen~     hydrochloride may treat or reduce the risk of breast cancer.~   "
19065|NCT03317392|"~     This phase I/II trial studies the best dose and side effects of olaparib and how well it~     works with radium Ra 223 dichloride in treating patients with castration-resistant prostate~     cancer that has spread to the bone and other places in the body. Olaparib may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth. Radioactive drugs,~     such as radium Ra 223 dichloride, may carry radiation directly to tumor cells and not harm~     normal cells. Giving olaparib and radium Ra 223 dichloride may work better at treating~     castration-resistant prostate cancer.~   "
19066|NCT03317379|"~     The goal of the study is to evaluate two 6-month adjunct interventions (peer mentorship and~     social support mentorship) for individuals with eating disorders. Individuals will be~     randomized to peer-mentorship, social support mentorship, or a wait-list and eating disorder~     symptoms will be evaluated at baseline and post-treatment.~   "
19067|NCT03317366|"~     ARQ 092 is being investigated for patients with overgrowth diseases and/or vascular anomalies~     with genetic alterations of the PI3K/AKT pathway and may be available for patients who are~     ineligible for an ongoing ARQ 092 clinical trial or have other considerations that prevent~     access to ARQ 092 through an existing clinical trial.~   "
19068|NCT03317353|"~     The aim of this study is to evaluate the effectiveness of vestibular rehabilitation to~     improve the balance in older people and reduce the number of falls, comparing three arms with~     different vestibular rehabilitation strategies (dynamic posturography exercises, optokinetic~     stimuli and exercises at home) and a control group.~   "
19109|NCT03316820|"~     This is single-center, single-dose, randomized, open-label, four-period, four sequence~     crossover study to evaluate the relative bioavailability of K0706 24 mg tablet formulation~     relative to 24 mg capsule formulation under fasted conditions and to evaluate the food-effect~     for tablet formulation in healthy subjects.~   "
19111|NCT03316794|"~     This is a multicenter, open-label study in participants with triple negative breast cancer~     (TNBC) to study the safety, tolerability, pharmacokinetics and preliminary efficacy of~     SC-005. This study consists of 2 parts: Part A (dose regimen finding) followed by Part B~     (dose expansion).~   "
19069|NCT03317340|"~     Urodynamics is a comprehensive study of the lower urinary tract. Although the information~     obtained from urodynamics answers several questions and assists in guiding therapies for~     patients, the testing environments is unnatural and may be distressing for patients. This may~     impact the results of the study, as it is not uncommon for patients to be unable to void for~     the test due to their distress. Often to alleviate the distress, music or soothing noises are~     used in the background. The study aims to identify simple environmental factors which may~     improve patient experience with urodynamic testing. The population will include patients with~     existing appointments for urodynamics testing at the Mayo Urology Clinic. The investigators~     plan to assess patient satisfaction and comfort during this assessment using a visual analog~     scale questionnaire. The environmental variables will include music of the patients'~     preference, the sound of running water, or no background noise at all. By asking patients to~     complete a questionnaire, The investigators will be able to assess ways to improve patient~     comfort in a commonly used urologic assessment.~   "
19070|NCT03317327|"~     Each subject will participate in the trial until death, drop out, or loss-to follow-up from~     the time the subject signs the Informed Consent Form (ICF) through the final contact. After a~     screening phase of up to 28 days, each eligible subject will receive nivolumab. Two weeks~     after start of nivolumab the patients will receive radiotherapy (RT) to a total dose of 60~     Gy, given as 1.5 Gy fractions twice daily for a total period of 4 weeks. Treatment with~     nivolumab will continue until disease progression, unacceptable adverse event(s),~     intercurrent illness that prevents further administration of treatment, Investigator's~     decision to withdraw the subject, noncompliance with trial treatment or procedures~     requirements, subject receives nivolumab for 12 months, pregnancy, or administrative reasons.~      After the end of treatment, each subject will be followed for 30 days for adverse event~     monitoring serious adverse events (SAEs) will be collected for 90 days after the end of~     treatment. Patients without disease progression will have follow-up visits for 4 years after~     end of study therapy.~   "
19071|NCT03317314|"~     This study aims to evaluate cardiopulmonary interactions in patients with heat failure~   "
19072|NCT03317301|"~     a Multicenter, Randomized, Double-blinded, Active-controlled, Parallel, Phase Ⅲ Study to~     Evaluate the Efficacy and Safety of HL151 versus Talion Tab. in Pruritus cutaneus.~      - Endpoint: VAS Score Change, Investigator's assessment of overall treatment~   "
19073|NCT03317288|"~     The purpose of this study is to test if the newly-developed Dabir alternating pressure (AP)~     overlay could be beneficial to preventing skin damage during daily activities, such as lying~     in bed. Specifically, the study is being done to test if the Dabir AP overlay could be used~     to increase skin tolerance when lying in bed for an extended period of time (40 minutes),~     including reducing pressure and increasing skin blood flow (amount of blood supply to oxygen~     and nutrients to skin) as compared to regular operation room (OR) overlay.~      A total of 20 participants with spinal cord injury will be recruited. Subjects will undergo~     study procedures including: AP and Control protocols. Skin blood flow and interface pressure~     will be collected non-invasively (from outside the body) during both protocols. During AP~     protocols, subject will be asked to lie on side (10 min), on back on AP overlay (40 min), on~     side (30 min), on back on OR overlay (40 min), and on side (10 min). During Control protocol,~     subject will be asked to lie on side (10 min), on back on OR overlay (40 min), and on side~     (10 min). Subject will then proceed to vascular control measures, including: non-invasive~     skin blood flow and tissue oxygen measurements with mild heating and electrical stimulation.~     Findings from this study will help us understand the effectiveness of the AP overlay on skin~     blood flow response during prolonged lying in bed.~   "
19074|NCT03317275|"~     Prior to the injection, the facet joints have to be defined according to standard~     radiological techniques (e.g. MRI and physical correlation). Patients are then sent to~     18F-Fluoride-PET/MRI imaging, in order to localize facet joints with increased uptake. Facet~     joints to be injected are again defined according to the location(s) of highest uptake as~     demonstrated by 18F-Fluoride-PET/MRI.~      The defined injection sites before and after PET/MRI are compared. In equal defined injection~     sites, patients are sent for infiltration as scheduled, otherwise patients are randomized~     into two groups.~      One group will undergo facet injection(s) according to the 18F-Fluoride-PET/MRI result, with~     standard injections performed under CT-guidance by the radiology department of the study~     site. The control group will undergo facet injections blinded to the 18F-Fluoride-PET/MRI~     results, but based on current standard clinical practise (MRI and clinical correlation).~      The patients are asked to complete a validated pain and function questionnaire immediately~     before the facet joint injection, at 15 minutes, 1 day, 1 week and 1 month after the~     injection, as performed routinely in our institution.~      The purpose of this study is to prospectively evaluate the value of 18F-Fluoride-PET/MRI~     imaging in patients with low back pain with evidence of painful facet joint arthropathy,~     which would potentially benefit from facet joint injections.~   "
19075|NCT03317262|"~     Depression is a psychiatric disorder that affects mood, thoughts and is usually accompanied~     by physical annoyances. It affects the person's eating habits, his sleep, the way he sees~     himself and the way he thinks and understands. Depressed emotion has great tension, lasts~     longer and leads to a reduction in the person's functioning in many areas of his life.~      Generalized Anxiety Disorder (GAD) is the psychiatric disorder characterized by a multitude~     of diverse organic responses as well as a generalized, persistent and indeterminate anxiety~     that covers almost all of the individual's activities. It is a diffuse and intense negative~     mood and anxiety that is present for most of the day and whose exact causes are often~     undetectable.~   "
19076|NCT03317249|"~     A feasibility study into the exploration of possible mechanisms underlying inappropriate~     sinus tachycardia (IST) syndrome in pregnancy.~   "
19077|NCT03317236|"~     Bioequivalence study of quetiapine in healthy volunteers, comparing the test extended release~     formulation, Kemoter XR with respect to the reference product, Etiasel XR ® from AstraZeneca~     S.A., under a single-dose, two-way crossover design.~   "
19078|NCT03317223|"~     The current study is designed to demonstrate the non-inferiority of CJ-12420-based triple~     therapy (CJ-12420, amoxicillin and clarithromycin) versus lansoprazole-based triple therapy~     (lansoprazole, amoxicillin and clarithromycin) in H. pylori eradication rate and to evaluate~     the safety of CJ-12420 following oral administration of either triple therapy twice daily for~     7 days in H. pylori positive patients.~   "
19081|NCT03317184|"~     Despite efforts to optimize the transplantation of deceased donor kidneys, the number of~     available kidneys continues to fall short of the demand. Living donor kidneys have been used~     to overcome this shortage. Graft and patient survival is significantly higher following~     living donor kidney transplantation compared with deceased donor kidney transplantation. Open~     donor nephrectomy was the universal technique prior to the advent of laparoscopic techniques.~     Laparoscopic approaches have definite advantages over open surgery in terms of blood loss,~     postoperative pain, analgesic requirements, duration of hospital stay, and convalescence.~     There is some controversy regarding longer warm ischemia time, longer operative time, and~     increased bleeding with laparoscopic nephrectomy compared with hand-assisted laparoscopic~     living donor nephrectomy (HALDN). HALDN attempted to reduce warm ischemia time by using the~     hand port to extract the kidney instantly after dividing the blood vessels. This technique~     also offers tactile feedback, better manual control of bleeding, a relatively shorter~     learning curve, less kidney traction, faster kidney removal, and shorter warm ischemic~     periods. HALDN is often performed using periumbilical and Pfannenstiel incisions for~     hand-assisted port placement. Pfannenstiel incisions improve wound complications such as~     incisional hernia, cosmetic issues, and wound dehiscence. However, duration of surgery,~     postoperative pain score, and length of hospital stay are significantly lower in donors with~     periumbilical incisions.To the best of our knowledge, these two types of incision have not~     been compared in a randomized controlled trial in patients undergoing HALDN. Our objective is~     to compare the results of Pfannenstiel incision (intervention group) with periumbilical~     incision (control group). The return to normal physical activity will be evaluated in a~     clinical randomized trial using an expertise-based design.~   "
19082|NCT03317171|"~     The study aimed to assess the safety and, partially, the efficacy of dietary supplementation~     of a flavonoids-, DHA- and EPA-based natural supplement in non-ambulant DMD boys and in a~     cohort of LGMD and FSHD patients to compare its effect in MDs of different aetiology and to~     eventually highlight any differences in inflammatory involved pathways. To assess safety,~     patient's laboratory parameters were monitored and adverse events recorded, while efficacy~     was evaluated through performance scale questionnaire and strength measurement (6 minute~     walking test and Biodex System 4 Dynamometer parameter evaluation). This study was conceived~     as proof of principle for the safe use of flavonoids/omega3s-based compound as an adjuvant in~     the management of neuromuscular disorders; besides, its efficacy in alleviating symptoms~     linked to secondary effects of genetic mutation as inflammation, muscular pain and weakness~     was assessed.~   "
19083|NCT03317158|"~     A multi-arm multi-stage (MAMS) phase 1/2 study. Phase 1 will be conducted in BCG-unresponsive~     NMIBC patients to establish the safety of durvalumab monotherapy (cohort 1) and durvalumab in~     combination with BCG (cohort 2a) and external beam radiation therapy (EBRT) (cohort 2b).~     Provided safety is demonstrated and recommended phase 2 doses (RP2D) are established in phase~     1, the study will proceed to phase 2 testing. Phase 2 will be conducted in the BCG-relapsing~     NMIBC population. In phase 2, BCG-relapsing NMIBC subjects will be randomized between~     treatment arms examining intravesical BCG in combination with novel immunotherapy agents~     (durvalumab), novel immunotherapy in combination with radiation (durvalumab + EBRT), or~     retreatment with intravesical BCG. In addition to providing additional safety data on the~     combination regimens studied, phase 2 will provide preliminary efficacy profiles for~     BCG-relapsing NMIBC subjects with and without CIS treated with each regimen. For regimens~     demonstrating a tolerable safety profile and encouraging clinical activity in this phase 1/2~     design, a randomized phase 3 trial of experimental arm therapy versus re-treatment with~     intravesical BCG therapy would be considered.~   "
19084|NCT03317145|"~     The aim of this pilot study was to assess venous flow parameters in patients following total~     hip arthroplasty, comparing an intermittent pneumatic compression foot device with a portable~     neuromuscular electrostimulator device. Assessments were performed in a single sitting before~     hospital discharge, between days 1 to 4 post operatively. The total duration of participation~     for each patient who completed the study was approximately 2.5 hours.~   "
19085|NCT03317132|"~     Background: To improve employment prospects for people in the chronic stages of mental~     illness, the gold standard is a program called Individual Placement and Support (IPS). Little~     research on IPS has been done with clients in the early stages of mental illness. This~     project aims to assess the incremental effectiveness of the IPS model of employment support~     over treatment-as-usual in a representative sample of early-psychosis clients . Method: One~     hundred consenting clients from the Fraser Health Early Psychosis Intervention (EPI) program~     will be recruited and randomly assigned to receive either one year of IPS support or~     treatment as usual (i.e., no IPS support but no constraints on the clients to seek other~     employment or related support themselves). Our primary hypothesis is that the early-psychosis~     clients receiving the IPS intervention will obtain and maintain more paid employment compared~     to the TAU (treatment as usual) group. Secondary hypotheses pertain to employment success as~     a function of both fixed and dynamic factors and assessing the cost-effectiveness of IPS.~   "
19086|NCT03317119|"~     This phase I trial studies the side effects and best dose of trametinib and TAS-102 in~     treating patients with colon or rectal cancer that has spread to other places in the body or~     cannot be removed by surgery. Trametinib may stop the growth of tumor cells by blocking some~     of the enzymes needed for cell growth. Drugs used in chemotherapy, such as TAS-102, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Giving trametinib and TAS-102 may~     prevent cancer cells from dividing and work better in treating patients with colon and rectal~     cancer.~   "
19087|NCT03317106|"~     this study examines the incidence of newly developed delirium in patients who admit to~     university hospital stroke unit for cerebral infarction, and analyze the association between~     delirium motor subtypes and short-term outcome in post-stroke delirium patients.~   "
19088|NCT03317093|"~     Ceftobiprole is a very active new cephalosporin on staphylococci resistant to methicillin~     (SEMR: Staphylococcus epidermidis Resistant to Meticillin, SAMR: Staphylococcus aureus~     Resistant to Meticillin) and / or vancomycin; it is also very active on pneumococci resistant~     to penicillin and / or 3rd generation cephalosporins. This new drug has AMM in nosocomial~     respiratory infections, Animal work shows the efficacy of ceftobiprole in gram negative~     bacillus meningeal infections.~      The rationale of this study is based on the antibacterial spectrum of ceftobiprole, which~     would therefore be useful in the treatment of staphylococcal bacterial meningitis resistant~     patients (SEMR or SAMR) encountered in intensive care and / or neurosurgery and in the~     treatment of pneumococcal meningitis.~      To validate these possibilities, it is necessary to know the concentrations of ceftobiprole~     in the meningeal space.~   "
19132|NCT03316521|"~     Safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a Single Ascending~     Dose (SAD) and a Multiple Dose (MD) of the complement inhibitor AMY-101. A prospective,~     single-center, open-label, First-In-Human (FIH) clinical study in healthy male volunteers.~   "
19089|NCT03317080|"~     This study aims to promote the rational use of liquid biopsy in the clinical detection of~     lung cancer. Lung cancer is a malignant tumor with high morbidity and mortality worldwide.~     The incidence of lung cancer in China is expected to increase in the next few years with the~     aging population and environmental pollution. Early diagnosis and effective intervention are~     necessary in the clinical treatment of lung cancer. Surgical resection could achieve a better~     prognosis for patients with early lung cancer. However, for advanced lung cancer,~     individualized treatment based on the pathological classification, molecular genetic~     characteristics, and body conditions of patients could effectively prolong the lifetime. The~     prevention, diagnosis, and intervention strategies for lung cancer depend on the oncology~     information of patients. The techniques and methods used for detecting lung cancer in clinic~     include imaging technology, pathological biopsy, screening of blood tumor markers, and liquid~     biopsy technology, which has been developed recently. The liquid biopsy can capture the~     oncology information, including tumor load, tumor gene mutation, and so on, from the blood of~     patients with cancer by detecting circulating tumor cells, tumor exosome, circulating tumor~     DNA, and circulating tumor RNA. Moreover, it has become an important direction for clinical~     tumor detection because of its noninvasiveness, convenient sampling, and potential for~     overcoming tumor heterogeneity. This study intends to include 1000-2000 patients with stages~     I-IV lung cancer to research on lung cancer diagnosis, drug efficacy, surgical effect~     evaluation, recurrence monitoring, prognosis judgment, medication guidance, and molecular~     classification differentiation through the dynamic detection of blood ctDNA using the~     second-generation sequencing technology. The study also intends to analyze and establish the~     database with a large sample size.~   "
19090|NCT03317067|"~     The primary purpose of the study is to evaluate whether dexmedetomidine is effective in~     treating agitated delirium of non-intubated ICI patients~   "
19091|NCT03317054|"~     Introduction: To date, very few studies about links between work and addictive disorders~     concern behavioral addictive disorders such as gambling. Such behaviours may be adaptative~     strategy for unsatisfied workers. The common physiopathology of addictive disorders allows us~     to hypothesize that it is possible that such troubles at work could promote gambling. Our aim~     was to evaluate the prevalence of gambling among workers and its links with work.~      Patients and methods: We performed a descriptive cross-sectional monocentric study among all~     workers who consulted one physician between November 2016 and April 2017, from an~     occupational health service in Brittany, France. The first step was to ask whether they have~     gambled during the last year and if it was related to their occupation. The second step was a~     screening for risky gamblers (using the Lie or Bet questionnaire) among these and then to~     assess more precisely the severity (using the Indice Canadien du Jeu Excessif, ICJE~     questionnaire).~   "
19092|NCT03317041|"~     Reducing fatigue and improving the recovery capabilities of runners has gained more interest~     over the last years. Recently, capacitive-resistive electric transfer (Tecar) therapy is~     commonly used by physical therapists to help athletes recover from muscle fatigue. However,~     empiric evidence supporting the benefits of Tecar to recovery is lacking. This study~     investigated the effects of a Tecar treatment performed shortly after an exhausting training~     session on both physiological and biomechanical parameters of running.~   "
19093|NCT03317028|"~     The objective of the study is to compare the efficacy and safety of 3 doses CS02 Tablet in~     combination with a stable dose of metformin monotherapy against CS02 PTM (placebo) Tablet in~     combination with a stable dose of metformin monotherapy over a 12 weeks treatment period in~     subjects with type 2 diabetes mellitus with inadequate glycemic control on metformin alone.~   "
19094|NCT03317015|"~     Primary Objective:~        -  To assess efficacy of Nasacort® (triamcinolone) nasal spray, 55 µg per dose, in~          comparison with Flixonase® (fluticasone) nasal spray, 50 µg per dose, by reflective~          total nasal symptom score (rTNSS) (24 h) after 28 days of treatment compared with~          baseline (0 day of treatment) in adult patients suffering from PAR (perennial allergic~          rhinitis).~      Secondary Objectives:~        -  To evaluate safety of Nasacort® (triamcinolone) nasal spray, in comparison with~          Flixonase® (fluticasone) administered for 28 days by assessment of adverse events~          reports.~        -  To evaluate patient and physician satisfaction after 28 days of treatment by 5-point~          scale.~        -  To estimate improvement of quality of life during the study by mini Rhinoconjunctivitis~          Quality of Life Questionnaire (miniRQLQ).~   "
19095|NCT03317002|"~     This is a randomized, single-blind, placebo-controlled, parallel-group, multicentre study in~     patients with CAD. The study will be conducted at approximately 10 centres in 3 countries.~     Approximately 138 CAD patients will be randomized to AZD5718 or placebo (treatment duration~     12 weeks).~   "
19096|NCT03316989|"~     Background: Melatonin is a neurohormone that regulates the circadian rhythm by translating~     photoperiodic information from the eyes to the brain.~      Working hypothesis and aims: There is a possible link between circadian rhythm regulation and~     glucose homeostasis through melatonin pathways. We aim to examine the relation between~     melatonin levels and degree of obesity , in children and adolescents in different pubertal~     stages.~      Methods: The study group will include 24 children and adolescents in various stages of~     pubertal development. Participants will be categorized into 3 groups: 1) normal-weight, 2)~     obese subjects with metabolic syndrome, 3) obese without metabolic syndrome. Melatonin levels~     will be measured using saliva during the night.~      Expected results: We expect to find a relation between melatonin levels to the metrics of~     metabolic syndrome, sleep duration, number of television viewing hours and sense of~     depression.~      Importance: Childhood obesity is recognized as a major medical and public health problem and~     is strongly associated with many serious medical complications including the metabolic~     syndrome and Type 2 diabetes (T2DM). It is important to understand mechanisms involved in the~     development of obesity and hyperinsulinemia.~      Probable implications to Medicine: Foreseeing a connection between melatonin levels and the~     degree of obesity and metabolic syndrome in children and adolescents, we would recommend~     addressing duration of sleep while treating obesity.~   "
19097|NCT03316976|"~     The purpose of this study is to assess the pharmacokinetics after a single dose of~     dexlansoprazole 30 and 60 mg delayed-release capsules in healthy Chinese participants.~   "
19098|NCT03316963|"~     The study team is seeking a novel treatment for snoring involving local application of a~     nerve stimulant medication, neostigmine. In this study, neostigmine will be injected into 5~     sites of the soft palate during a standard procedure, drug-induced sleep endoscopy, to~     evaluate the effect on snoring.~   "
19133|NCT03316508|"~     This study evaluates the relevance of Copeptin in children with congenital heart disease~     undergoing cardiac surgery with the need of cardiopulmonary bypass. Three blood samples are~     taken of each patient. The first and second sample are collected in the operation room before~     and after the procedure and the third sample on the first postoperative day at the intensive~     care unit.~   "
27147|NCT03211663|"~     This is a prospective, multi-center study, designed to assess mid-term performance of the~     MOTO Medial® Unicompartmental Knee Arthroplasty (UKA), with patient report outcomes, clinical~     findings and radiographic analysis.~   "
19099|NCT03316950|"~     This is a single-center, randomized, prospective study designed to evaluate the efficacy of~     radiofrequency and hybrid fractional laser for vaginal rejuvenation. 100 subjects will~     undergo a three-part treatment of the vulvovaginal area using radiofrequency unit,~     radiofrequency placebo, DiVa HFL unit, or DiVa HFL unit placebo. These treatments will be~     spaced one month apart and last about 25 minutes each. Each subject will be screened, undergo~     testing at baseline, and will be followed conservatively with no further therapy until they~     reach 6 months after the initiation of the designated treatment. At that time, all subjects~     will undergo subjective and objective testing. Those in the treatment group will be followed~     to 9 and 12 months after the initiation of treatment with appropriate analysis. Those in the~     placebo group will have completed the study at this time and will be provided treatment,~     should they choose. The primary outcome measure is improvement in vulvovaginal symptoms~     measured by the validated Vulvovaginal Symptoms Questionnaire and vaginal laxity, measured by~     the Vaginal Laxity Questionnaire. Data obtained from each investigation will be recorded in a~     password-protected digital spreadsheet, and descriptive statistics will be obtained.~   "
19100|NCT03316937|"~     The buccal and lingual surface of the 23 participants' crowns will be randomly assigned to~     receive scaling and root planing with either Teflon scalers, or non-Teflon scalers after~     implant crown delivery. Each patient will act as their own control.~      Patients will receive scaling and root planing at 3, 6, 9 and 12 months by a calibrated~     dental hygienist. All surfaces of the implant will be debrided for 1 minute using a~     transversal movement. Each patient will receive oral hygiene instructions by the hygienist at~     the end of each maintenance therapy appointment. The participants will be instructed to use a~     Modified Stillman brushing technique twice per day and cross shoe shine flossing motion once~     per day. Each patient will be provided with a three-month home care kit with dental aids.~     These aids will consist of toothpaste, a toothbrush and implant floss.~      Measurements will be taken at 0, 3, 6, 9 and 12 months by a calibrated periodontal resident.~     The parameters assessed at the implant site and patient level will be modified plaque index~     (IPI) by Mombelli, modified gingival index (IBOP) by Mombelli, implant probing depths (PD) at~     six sites, presence of keratinized gingiva (KT), recession (REC), Full mouth plaque index~     (FPI) and Full mouth bleeding on probing (FBOP).~      The Peri-implant Crevicular Fluid will be collected at 0, 3, and 12 months by isolating the~     implant site from saliva and introducing Periopaper strips into the buccal, mesial, distal~     and lingual sites of the implant sulcus for 30 seconds. The strips will be placed in a sealed~     Eppendorf tubes and transported by portable freezer to the laboratory where they will be~     stored at -86 degrees Celsius. The Periopaper samples will be treated for the detection and~     quantification of the following cytokines: Interleukin-2, Interleukin-4, Interleukin-6,~     Interleukin-8, Interleukin-10, Tumor Necrosis Factor alpha and Interferon gamma.~      Periapicals will be taken at baseline and 12 months. All radiographs will be standardized.~      After 12 months, the implant crown will be removed and the implant crown's surface~     alterations will be evaluated using atomic force microscopy (AFM) using the RA, or average~     roughness, and the RZ, or mean roughness depth, scores. The implant crown surface will then~     be repolished/reglazed and delivered back to the patient's mouth. Crowns will be evaluated~     before delivery to determine adequate level of smoothness.~      Based on the presence of cytokines in the Peri-implant Crevicular Fluid, the degree of~     surface alterations, the modified plaque index, implant probing depths, full mouth plaque~     index, and full mouth bleeding on probing, we can determine if scratching affects the~     inflammation around the screw retained dental implant.~   "
19101|NCT03316924|"~     In case of CDH, the incomplete development of a part of the diaphragm allows abdominal~     viscera to herniate into thorax cavity during fetal development and impaired lung and heart~     development.~      After birth, CDH patients who survived thanks to an active reanimation management undergo~     diaphragmatic repair. In case of large defect, a patch is needed to complete diaphragmatic~     closure. Thanks to primary cell culture from foreskin, peritoneal epithelium or cremaster~     dedicated to incineration investigators want to analyse biological integration of actually~     used prothesis and others innovations.~   "
19102|NCT03316911|"~     This study utilizes implementation science principles to culturally adapt a pre-existing~     web-based application (WebApp) for use with college students. The ADAPT-ITT process will be~     utilized to adapt the WebApp to a diverse (race, ethnicity, gender/sexual identity) college~     population with a focus on life skills and holistic self-care as reinforcement to currently~     available primary prevention programming available to incoming students. The study hypothesis~     is that the adapted WebApp will be usable, acceptable, and students will be willing to use it~     as a reinforcement to current university primary prevention programming. The study team will~     also monitor retention of participants over the academic year.~   "
19103|NCT03316898|"~     This is a study to evaluate the brain metabolic response using Fluorodeoxyglucose Positron~     Emission Tomography (FDG-PET), safety, tolerability and pharmacokinetics of AGN-242071 in~     patients with mild to moderate Alzheimer's Disease on a stable dose of 10 mg donepezil with~     or without memantine standard of care.~   "
19104|NCT03316885|"~     The primary purpose of this study is to demonstrate the long-term (3 years) favorable visual~     acuity and adverse event outcomes for the Clareon® Intraocular Lens (IOL) compared to~     historical safety and performance endpoint (SPE) rates as reported in EN ISO 11979-7:2014.~     The secondary purpose of this study is to evaluate the refractive outcomes obtained with up~     to 3 years follow-up in eyes implanted with the Clareon® IOL.~   "
19105|NCT03316872|"~     This is a phase 2 study whose purpose is to assess the efficacy of the combination of~     pembrolizumab and stereotactic body radiotherapy (SBRT) in patients with advanced~     hepatocellular carcinoma (HCC) who have experienced disease progression after treatment with~     sorafenib.~   "
19106|NCT03316859|"~     This is a double-blind, randomized, placebo-controlled trial to examine the effectiveness of~     adding one 25mg dose of naloxegol to the cardiac surgery pre-operative regimen.~   "
19107|NCT03316846|"~     This study is a randomized controlled trial studying the efficacy of an iCBT treatment for~     patients with chronic pain and comorbid psychiatric distress. Half the participants will~     receive treatment at first, while the other half serve as a control group. After the first~     group has received treatment, the same program will be offered to participants in the control~     group. Treatment will be tailored on the level of individual participants, enabling~     individuals suffering a wide range of problems to be recruited. The treatment will consist of~     a 10-week guided self-help program, followed by a booster program and follow-up one year~     later. During the curse of the treatment the participants will be guided via text~     communication by a licensed psychologist or a candidate psychologist on their last year of~     studies.~      The primary hypothesis is that an individually tailored CBT-treatment administered through~     the internet can be beneficial for patients suffering from chronic pain and comorbid~     psychiatric distress. The investigators expect that patients in the treatment group will show~     reduced levels of disability, depression and anxiety, while improving on scales measuring~     coping and quality of life.~   "
19108|NCT03316833|"~     The primary objective of this study is to assess the safety and efficacy of the~     new-generation zotarolimus-eluting stent Resolute Onyx in the treatment of unprotected left~     main coronary artery disease (ULMCAD), both isolated or in association with two- or~     three-vessel coronary artery disease.~   "
19112|NCT03316781|"~     This is a multicenter, randomized, double-blind, positive drug parallel-group controlled~     clinical study in China to evaluate efficacy, safety, tolerability and immunogenicity of~     HLX03 and adalimumab (Humira) in subjects with moderate to severe plaque psoriasis. This~     study will recruit 216 subjects (18-75 years old, male and female) with moderate to severe~     plaque psoriasis. The 216 subjects will be randomly assigned per 1:1 ratio into the following~     two treatment groups (HLX03 OR Adalimumab). The study will be conducted in three periods,~     including the screening period, treatment period and follow-up period. For each participating~     subjects, the maximal length of the study will be 56 weeks (including up to four weeks of~     screening time).~   "
19113|NCT03316768|"~     Very little is known about the pinch and grip forces that are critical for activities of~     daily living (ADL) or work. Human success in evolution is a result of the combination of~     great brain power and great hand ability to accomplish with our hands what our minds can~     conceive. Prehensile grasp in hominins allowed tool production and today allows us to hold~     fine instruments to perform surgery or do heavy construction. The strength of our hands is~     matched against the requirements of the activities we need to perform. The hypothesis of this~     study is that many tasks have an inherent strength requirement that is independent of the~     person performing the task. Until recently, direct measurement of the forces has not been~     possible. Ultra thin sensors along with the software to interpret the information is now~     available to make this force determination possible. We have 3 primary objectives. The~     primary objective is to measure pressure distribution and resultant forces needed for 3~     categories of ADL and 2 categories of work in normal subjects. The second objective is to~     perform a similar evaluation of patients with basilar thumb arthritis and after wrist~     fracture. The third objective is to measure pressure distribution and forces needed for tool~     production and use.~   "
19114|NCT03316755|"~     This study aimed at understanding the impact of educational pamphlet on Risk Perception of~     Periodontal Disease using A Randomised Clinical Trial model among patients in a Nigerian~     outpatient dental clinic~   "
19115|NCT03316742|"~     The purpose of this study is to test two versions a weight loss program potentially suitable~     for implementation in Africa. A successful method would have widespread application in~     low-income countries, with the potential to improve world health.~   "
19116|NCT03316729|"~     The primary objective of this study is to evaluate safety and initial effectiveness of~     DS-9231 when taken together with current standard of care. Evaluation will be done with low,~     medium and then high doses of DS-9231 versus placebo, in participants with medium-risk acute~     pulmonary embolism.~   "
19117|NCT03316716|"~     Peri-operative warming is well established for general operations, but there is limited~     literature on the active warming of pregnant women undergoing caesarean section (CS).~     Specifically, there is a lack of evidence on the effect, if any, of actively warming mothers~     on the new-born's temperature and general wellbeing. The two active warming methods~     recommended by NICE are the use of forced-air warming and fluid warmers.~      Women's temperature tends to fall below the normal level (36.0oC to 37.5oC) during caesarean~     section if they have not been actively warmed during their operation (peri-operative).~     Peri-operative hypothermia may increase the morbidities experienced by women after caesarean~     section. While shivering is the most common postoperative incident, hypothermia may delay~     wound healing or increase the risk of wound infection, and can increase the risk of~     haemorrhage.~      Neonatal hypothermia has a direct effect on the baby's cardiopulmonary, vascular system and~     central nervous system and increases the risks of mortality and morbidity. Specifically,~     neonatal hypothermia can lead to respiratory difficulties and apnoea, hypoxemia, carbon~     dioxide retention, metabolic acidosis, hypoglycaemia and decreased oxygen delivery to the~     tissues.~      The absence of research and evidence on the effects of actively warming women undergoing~     caesarean section at term gestation on the temperature of new-borns during SSC means that~     further research is required.~   "
19118|NCT03316703|"~     The thoracolumbar segment fractures are the most frequent along the spine, and surgical~     treatment is indicated in unstable fractures. Surgical treatment has been performed through~     the posterior fixation pedicle fixation systems, and where necessary complemented by~     decompression of the spinal arthrodesis and previous channel. Surgical treatment has been~     performed by conventional open approach through the posterior incision on the midline, and~     detachment and removal of paraspinal muscles to access the posterior vertebral elements. The~     percutaneous minimally invasive surgery was introduced in the context of spinal surgery to~     reduce the morbidity associated with conventional open approach. It has been reported the~     lowest bleeding intra- and postoperative period, less pain, shorter hospital stay,~     rehabilitation and return to work faster with less use of minimally invasive percutaneous~     approach of the spine. However, predominates in the literature of clinical case reports and~     few prospective and randomized clinical trials. The performance of prospective randomized~     clinical trials have been required for the evaluation of the benefits of minimally invasive~     surgery in the treatment of the thoracolumbar spine fractures. The objective of the study is~     to compare the surgical treatment of fractures of the thoracolumbar spine using the~     conventional open approach or minimally invasive percutaneous approach to the stabilization~     of the vertebral segment affected, and using similar type of pedicle spinal fixation system.~     Patients will be evaluated in the preoperative, postoperative, 1,2,3,6,12 and 24 months by~     parameters related to the perioperative (intraoperative bleeding, surgery time), clinical~     (VAS, SF-36, HADS, EQ-5D-5L), images (radiographs and computed tomography). The study results~     will impact the guidelines of the surgical treatment of thoracolumbar spine fractures and may~     indicate the advantages or disadvantages of using surgery through conventional open approach~     to minimally invasive percutaneous surgery.~   "
19119|NCT03316690|"~     Physical activity is a first line treatment for patients with type 2 diabetes (T2D), however,~     the vast majority of patients with T2D do not achieve satisfying glycemic control with~     physical activity alone, which is why pharmacological treatment with metformin is most often~     initiated.~      It is known that metformin and exercise both activates 5' adenosine monophosphate-activated~     protein kinase (AMPK) in skeletal muscle and liver, and the activation of AMPK results in~     many different metabolic effects, including improvements in glycemic control. Because of this~     similarity in mechanism of action, an interaction between metformin and exercise is~     plausible, but knowledge in the area is sparse. Thus, the aim of this study is to assess the~     effects of training with and without concomitant metformin treatment, in order to investigate~     whether an interaction between the two occur.~      Subjects with impaired glucose tolerance will all undergo 12 weeks of training but will be~     randomized (1:1) to concomitant metformin/placebo treatment in a double-blinded way.~     Experimental days will be performed before randomisation (before initiation of~     metformin/placebo treatment), before initiation of the training period and after the training~     period.~   "
19287|NCT03314493|"~     Vascular calcification is a frequent complication in dialysis patients and is strongly~     associated with mortality. Its pathogenesis is complex and involves a series of markers that~     act on the vascular microenvironment. There is evidence that aldosterone is one of the~     biomarkers and may have a role in osteoinductive pathways.The aim of this study was to~     evaluate the effect of spironolactone, an inhibitor of mineralocorticoid receptor, in the~     progression of coronary calcification in patients undergoing peritoneal dialysis.~   "
19120|NCT03316677|"~     A leak from a colorectal anastomosis is a post-operative complication surgeons fear the most,~     following colonic resection. Over the years, there have been multiple suggestions for~     intraoperative tests for the integrity of the colorectal anastomosis.~      Two of the most common tests that are performed routinely are:~        1. Air tight leak test - filling the pelvis with saline and insufflating air trans anal -~          looking for air bubbles in the saline filled pelvis.~        2. Injecting diluted dye (methylene blue) trans anal, and looking for blue dye stains on~          gauze pads covering the outer side of anastomosis.~      The aim of the study is to compare the two methods, and to assess if there is a superior~     method. A secondary aim is to establish standards to perform the test, mainly to assess the~     appropriate pressure to apply on the anastomosis.~      In this prospective study patients scheduled to undergo colonic resection of their distal~     part of the colon/ rectum with colorectal anastomosis, will have both testing methods~     performed sequentially and will be followed post-operative to assess the yield and~     sensitivity of the testing methods.~   "
19121|NCT03316664|"~     This randomised three-arm study aims to evaluate the efficacy and feasibility of a cognitive~     behavioral therapy (INT-Integrated Neurocognitive Therapy for Schizophrenia Patients) in the~     treatment of schizophrenia patients in an inpatient setting. The intervention will be~     compared with an active comparator (IPT- Integrated Psychological Therapy) and a control~     condition. Overall the study will include 90 patients (30 in each arm). Each patient will~     receive at least 16 sessions of the respective treatment. Baseline and follow up assessments~     up to 12 months after the intervention will investigate the stability of treatment.~   "
19122|NCT03316651|"~     The purpose of the study is to evaluate the effectiveness of the sequential therapy with~     whole lung Lavage (WLL)/inhaling granulocyte-macrophage colony stimulating factor, compared~     to WLL only, for adult patients with severe autoimmune pulmonary alveolar proteinosis in~     China over a two-year period.~   "
19123|NCT03316638|"~     W0101 combines a cytotoxic compound to a monoclonal antibody targeting a receptor commonly~     overexpressed in many cancers.~      The development of antibody-drug conjugates takes advantage of the specificity of the mAb~     while augmenting its ability to produce a cytotoxic effect. The expected benefits of~     antibody-drug conjugation are enhancement of cytotoxicity in target cells and limiting~     toxicities of cytotoxic drugs in normal tissues.~      This is a First In Human study, multicenter, open label study divided into 2 parts: an~     initial dose escalation phase (I) followed by expansion cohort(s) phase (II).~   "
19124|NCT03316625|"~     In men, the hope of lower life, the absence of equivalent of menopause and the existence of a~     higher peak bone mass are three factors that explain the lower incidence of osteoporosis in~     men. Epidemiological data indicate a prevalence of 15% among men aged over 50 years (Szulc et~     al. 2000). According to global analyzes, the number of fractures of the upper end of the~     femur in humans will increase from 400 000 to 800 000 per year between 2000 and 2025 (Kanis~     et al. 2004). Furthermore the mortality due to major osteoporotic fractures when they occur~     in humans than that seen in women (Johnell and al.2001).The main goal of this study is to~     establish reference curves in elderly male volunteers from 20 to 30 years through the~     assessment of bone mineral density of the spine, hip, and the measurement of body composition~     (fat mass, lean mass). This study will allow us to establish the mean and standard deviation~     of the value of the young adults of the same sex, which will eventually be applied in the~     calculation of the T-score for older people.~   "
19125|NCT03316612|"~     Advanced glycation end-products (AGEs) has been linked to ageing, and many metabolic~     diseases. The findings of previous experiments suggested that the extracts from~     polyphenol-rich bilberry might inhibit the formation of AGEs. This is a randomized~     double-blind trial, aims to study the effect of Vaccinium Myrtillus L. natural extracts on~     AGEs and human metabolism. Firstly, we will investigate the efficacy of Bilberry extracts on~     lowering the levels of advanced glycation end-products (AGEs). Secondly, we will conduct 16S~     rRNA sequencing and ultra-high performance liquid chromatography-tandem mass spectrometric~     (UPLC-MS/MS) detection to explore the role of bilberry extracts on gut microbiota as well as~     metabolites.~   "
19126|NCT03316599|"~     To identify the maximally tolerated dose of ficlatuzumab when combined with nab-paclitaxel~     and gemcitabine in patients with previously untreated pancreatic cancer.~   "
19127|NCT03316586|"~     This research study is studying a combination of drugs as a possible treatment for metastatic~     triple-negative breast cancer.~      The drugs involved in this study are:~        -  Cabozantinib (XL184)~        -  Nivolumab~   "
19128|NCT03316573|"~     This research study is studying a drug called pembrolizumab as a possible treatment for~     aggressive lymphoma or a histiocyte or dendritic cell neoplasm.~      The drug involved in this study is:~      -Pembrolizumab~   "
19129|NCT03316560|"~     This study will evaluate the safety and efficacy of a recombinant adeno-associated virus~     vector expressing a human RPGR-ORF15 gene (rAAV2tYF-GRK1-RPGR) in patients with X-linked~     retinitis pigmentosa caused by RPGR-ORF15 mutations. Approximately 15 participants will be~     enrolled and 3 dose levels will be evaluated in a dose-escalation format.~   "
19130|NCT03316547|"~     Sixty-two preterm infants born less than or equal to 32 weeks gestation will be put into~     either the sensory-based intervention (experiment) group or traditional care (control) group.~     Consecutive admissions at St. Louis Children's Hospital (SLCH) who are hospitalized in a~     private NICU room will be recruited. The parents of infants in the sensory-based intervention~     group will be educated and supported by trained therapists to give different positive sensory~     experiences to their infants while hospitalized. The traditional care group with receive~     normal, standard care while hospitalized. For both care groups, infant neurobehavior, sensory~     processing, and parent mental health will be measured at term age prior to hospital~     discharge. Child development, sensory processing, and parent mental health will be measured~     again at age one year (corrected). Differences between the two groups will be explored.~   "
19131|NCT03316534|"~     The specific research questions addressed in the present study are:~        -  to investigate the impact of treatment with low-dose aspirin in HIV-1-infected patients~          treated with ABC and test it would result in decreased in vivo platelet activation and~          platelet hyperreactivity~        -  to investigate if aspirin has the same effects in HIV-infected as in HIV-uninfected~          patients.~   "
27148|NCT03211650|"~     The purpose of this study is to evaluate the efficacy of intra-articular injections of~     combined hyaluronic acid and platelet-rich plasma in knee degenerative joint disease in~     improving joint function and reducing pain.~   "
19134|NCT03316495|"~     Tobacco smoke is one of the most preventable cause of mortality and morbidity worlwide, this~     study is conducted to compare the knowledge of the health effects of smoking among~     undergraduates exposed and those not exposed to educational pamphlet. This is designed as a~     randomized clinical trial among 390 undergraduate in University of Benin Edo State Nigeria.~     Data collection tool was an interviewer-administered questionnaire. Data obtained would be~     subjected to regression statistics using IBM SPSS version 21.0. The expected outcome will be~     a veritable tool in tobacco cessation model.~   "
19135|NCT03316482|"~     A multicenter, open-label, prospective study to evaluate the safety and efficacy of~     leuprorelin acetate DPS (Leuplin DPS) treatment quarterly in patients with central precocious~     puberty~   "
19136|NCT03316469|"~     Polycystic ovary syndrome (PCOS) is found in 5% to 6% of women of reproductive age. It~     affects women's reproductive capability; thus patients have risks of infertility,~     miscarriage, and complicated pregnancy. A study revealed that the prevalence of~     oligoovulation or anovulation in patients with PCOS ranged from 65% to 80%. Anti-Mullerian~     Hormone (AMH) is an important regulator in the ovary that play a rule during development and~     function. It is suspected to affect clomiphene citrate (cc) resistance. In this study the~     investigator will assess the accuracy of AMH prediction of response to cc in women with PCOS.~   "
19137|NCT03316456|"~     This is an observational study to collect stool, blood, and urine from acute leukemia~     patients undergoing induction chemotherapy in order to generate preliminary data regarding~     the association between microbiota and chemotherapy-induced gut barrier damage. This study~     consists of inpatient collections of blood, urine, and stool while the patients are~     undergoing inpatient induction therapy. Patients will not be scheduled for any additional~     procedures or testing beyond what is required for clinical care.~   "
19138|NCT03316443|"~     Hemodynamic response to laryngoscopy and tracheal intubation remain of utmost concern in~     anesthesia practice. Sympathetic stimulation and adverse physiologic events could be~     tolerated by healthy individuals, but they may be detrimental in hypertensive patients.~      The magnitude of hemodynamic response of intubation is related to the degree of manipulation~     of the oropharyngeo-laryngeal structures. Unlike Macintosh laryngoscope,Glidescope is a~     device that does not require alignment of oropharyngeal axis to visualize the glottis.It~     needs less upward lifting force with less manipulation of pharyngeal structures during the~     intubation.~      It was reported that Glidescope had no significant advantage over Macintosh in attenuating~     circulatory response to endotracheal intubation in normotensive patients.Till now no clinical~     trials investigate the hemodynamic effects of Glidescope in hypertensive patients.The~     investigators hypothesized that the Glidescope will induce less hemodynamic changes among~     hypertensive patients during endotracheal intubation.So the study was designed to compare~     effects of Glidescope versus Macintosh laryngoscope in hypertensive patients with special~     regard to hemodynamics and intubation conditions.~   "
19139|NCT03316430|"~     Pre-eclampsia is an hypertensive disorder appearing during pregnancy, inducing serious~     maternal, fetal and neonatal mortality and morbidity. Podocyn could be identified in the~     urine, before proteinuria, a key element in the diagnostic of pre-eclampsia. Preventive~     treatment using aspirin could be administrated in early pregnancy. We hypothesized that~     podocyturia could be an early indicator of preeclampsia. This is a prospective,~     non-interventional, monocentric study.~   "
19140|NCT03316417|"~     Renal toxic events related to Immune Checkpoints Inhibitors therapy (Nivolumab,~     Pembrolizumab, Atezolizumab and Ipilimumab) have been recently reported. These were~     immune-allergic acute interstitial nephritis.~      However, no systematic study has ever focused on renal adverse effects. The investigators~     study here the evolution of renal function and the occurrence of nephrological events in a~     large monocentric cohort of patients treated with Immune Checkpoints Inhibitors in the Centre~     Hospitalier Lyon Sud. Nephrological parameters based on Serum Creatinine (SCr), estimate~     Glomerular Filtration Rate (eGFR) and urinary sediment are monitored. The aim of the study is~     to determine the incidence of renal events due to Immune Checkpoint Inhibitor treatment,~     particularly Acute Kidney Injury, (AKI) and identify the clinical presentation, histological~     description and risk factors.~   "
19141|NCT03316404|"~     To develop a test to characterize and monitor Multiple Sclerosis (MS) disease status and~     therapy response from a participant's home by analyzing the gene expression from participant~     self-collected blood samples using a novel fingerstick collection kit.~   "
19142|NCT03316391|"~     Pre-eclampsia is an hypertensive disorder appearing during pregnancy, inducing serious~     maternal, fetal and neonatal mortality and morbidity. Twenty four hours proteinuria is a key~     element to define pre-eclampsia severity but is delaying the result by 24 hours and~     constraining for the patient. A simple and rapid indicator for severe preeclampsia would help~     clinicians to make appropriate decision in patient management. We hypothesized that urinary~     podocyturia is correlated to preeclampsia severity. This is a prospective,~     non-interventional, monocentric study.~   "
19143|NCT03316378|"~     The purpose of this study is to better understand how the peripheral and central nervous~     system interact to produce the sensation of pain and motor patterns in patients with achilles~     tendinopathy (AT). These findings will motivate the development of future clinical studies~     that incorporate knowledge about pain processing and movement strategies in patients with~     tendinopathy. Participants with achilles tendinopathy will receive an anesthetic injection to~     the achilles tendon in order to examine how reduced pain, detected by the peripheral nervous~     system, alters task performance and perception of pain. We hypothesize that there are factors~     within the central nervous system that contribute to continued pain and disability in~     patients with chronic AT.~   "
19165|NCT03316092|"~     Oral Hydoxychloroquine is a very popular medication widely used by patients with rheumatoid~     arthritis, Systemic Lupus Erythematosus and other diseases. Ocular side effects of this~     medication are very serious and causes loss of central vision. In most patients these side~     effects are dose related, cumulative. This means that the risk of side effects would increase~     in all patients with continued use of the medication. In few people use of the medication~     would not be recommended if they have some bilateral macular problems. This is because the~     side effects of this medication does cause serious degredation of the macula in both eyes.~   "
22240|NCT03275935|"~     This study analyzes the prevalence of patients using inhalation devices via incorrect~     technique and access the adherence of patients to correct inhalation technique when taught~     along with their subjective improvement of symptoms.~   "
19144|NCT03316365|"~     Falls are common among patients with Parkinson's Disease (PD) and are the biggest~     contributors to loss of independent living, long-term institutionalization, and increased~     mortality.~      The purpose of this study was to explore whether an at-home based Rhythmic Auditory~     Stimulation (RAS) gait training program will decrease the number of falls in persons with PD~     with a history of falling. We also evaluated changes in clinical and kinematic parameters~     used to assess fall risk in this population.~      Sixty participants diagnosed with idiopathic PD with at least 2 falls in the past 12 months,~     were randomly allocated into two groups. The experimental group trained daily with RAS for 24~     weeks. The control group also trained daily with RAS, but discontinued training between weeks~     8 and 16. During treatment patients walked for 30 minutes in a home based environment with~     metronome-click embedded music. Changes in clinical and kinematic parameters were assessed at~     baseline, weeks 8, 16, and 24.~   "
19145|NCT03316352|"~     Multiple passes and attempts during spinal anesthesia might be associated with a greater~     incidence of paraesthesia, postdural puncture headache, and spinal hematoma. We hypothesized~     that the use of a preprocedural ultrasound-assisted paramedian technique for spinal~     anesthesia in patients with old age would reduce the number of passes required to entry into~     the subarachnoid space when compared with the landmark-guided paramedian approach. The study~     participants will be randomized into group L (landmark-guided) and group U~     (ultrasound-assisted). In group L, spinal anesthesia will be performed via paramedian~     approach using conventional landmark palpation technique. In group U, a preprocedural~     ultrasound scan will be used to mark the needle insertion site, and spinal anesthetic will be~     done via the paramedian approach.~   "
19146|NCT03316339|"~     Since the 1960's, intraoperative administration of opioids is considered a keystone of~     anesthesia as well as hypnotics and muscle relaxants. Synthetic opioids were introduced to~     achieve hemodynamic stability during anesthesia. They allow an inhibition of the sympathetic~     system without cardiovascular collapse and histamine release. Since then, anesthesia has~     changed from inhalation to multimodal anesthesia with lower doses of hypnotic. In 2017, the~     intraoperative objectives of hypnosis, hemodynamic stability, immobility and anticipation of~     postoperative analgesia can be achieved without opioids. Moreover, opioid administration~     consequences are neither scarce nor benign for the patient. Perioperative opioids are~     associated with nausea and vomiting, sedation, ileus, confusion/delirium, respiratory~     depression, increased postoperative pain and morphine consumption, immunodepression,~     hyperalgesia and chronic postoperative pain. Among these complications, hypoxemia, ileus and~     confusion/delirium are the most frequent.~      Efficacious multimodal analgesia and anesthesia are the basis of successful fast-track~     surgery. These multidrug regimens aim at decreasing postoperative pain, intra- and~     postoperative opioid requirements, and subsequently, opioid-related adverse effects and to~     fasten recovery. Opioid-free postoperative analgesia has been recommended for more than 10~     years. Opioid-free anesthesia (OFA) is based on the idea that hemodynamic stability can be~     achieved without opioids during anesthesia. OFA is multimodal anesthesia associating~     hypnotics, N-methyl-D-aspartate (NMDA) antagonists, local anesthetics, anti-inflammatory~     drugs and alpha-2 agonists (Dexmedetomidine).~      Proofs of the effect of OFA on reducing opioid-related adverse effects after major or~     intermediate non-cardiac surgery are still scarce. We hypothesized that the reduced opioid~     consumption during and after surgery allowed by OFA compared with standard of care will be~     associated with a reduction of postoperative opioid-related adverse events.~   "
19147|NCT03316326|"~     This phase II clinical trial will enroll patients with newly-diagnosed locally-advanced~     pancreatic adenocarcinoma and adopt the Simon's two-stage optimum design. After 4 cycles of~     SIROX regimen, patients will proceed to curative resection.~   "
19148|NCT03316313|"~     The purpose of this study is to determine whether patient education improves Hepatitis C~     screening in the primary care setting.~   "
19149|NCT03316300|"~     This study is a phase 3, randomized, multi-center study to evaluate the efficacy and safety~     of the Renexus® implants in participants with macular telangiectasia type 2.~   "
19150|NCT03316287|"~     Hearing Loss (HL) affects over 5% of the world's population (WHO 2014) and is the 5th leading~     cause of Years Lived with Disability. HL is currently managed with Hearing Aids (HAs), i.e.~     programmable sound amplification devices that are worn by the hearing impaired subjects to~     address their hearing difficulties. HA use however is often problematic, costly and with poor~     overall benefits. The holistic management of HL requires appropriate public health policies~     for HL prevention, early diagnosis, long-term treatment and rehabilitation; detection and~     prevention of cognitive decline; and socioeconomic inclusion of HL patients. Currently the~     evidential basis for forming such policies is limited.~      The EVOTION project proposes to address this by collecting and analysing a big set of~     heterogeneous data, including HA usage, audiological, physiological, cognitive, clinical and~     medication, personal, behavioural, life style, occupational and environmental data.~      This will be done by:~      i. accessing big datasets of existing HA user data from the EVOTION clinical partners~     (UCL/UCLH and GST in the UK; OTICON in Denmark) ii. collection of prospective HA user data~     who will be recruited to the prospective EVOTION study and who will undergo some additional~     assessments iii. collection of real time dynamic data of the human participant HA users who~     will be given a smart phone with different apps (auditory tests; auditory training), sensors~     (recording of heart rate, blood pressure, respiratory rate etc.) and smart HAs (recording~     environmental factors such as noise levels, type of noise etc.) so that real life contextual~     factors that affect HA usage and outcome can be identified.~      These data will be analysed with big data analysis/data mining techniques in order to~     identify relationships between these in order to use this information to derive and support~     public health decisions.~   "
19151|NCT03316274|"~     There is no clear treatment for patients with limited cutaneous Kaposi sarcoma (KS).~     Radiation and injection of vinblastine both have side effects that may not be acceptable.~     Nivolumab has been used to treat more extensive KS when given intravenously. This is, to the~     investigators' knowledge, the first trial to see if nivolumab can be used as treatment in the~     form of an injection into KS lesion.~   "
19152|NCT03316261|"~     The Freder1k-Study will identify infants who have a high genetic risk of type 1 diabetes.~   "
19153|NCT03316248|"~     This study was conducted to examine the effect of visual feedback on function, stability and~     quality of life in transtibial amputees. A total of 24 subjects who had unilateral~     transtibial amputations, used prosthesis with total surface bearing socket (TSB) for at least~     1 year and volunteered to participate in the study were included. Before and after Treatment~     subjects were evaluated with LASAR Posture for prosthetic weight bearing (PWB), Berg~     Balance Scale (BBS) and Timed Up& Go Test (TUG) for balance and functional mobility,~     2-Minute-Walk-Test (2MWT) for physical performance, Satisfaction with the Prosthesis~     Questionnaire (SATPRO) for prosthetic pleasure and Nottingham Health Profile (NHP) for~     health- related quality of life. Participants were randomly divided into two equal groups as~     study and control groups. After the evaluations the same exercises; PWB exercises, balance~     exercises, anteroposterior and lateral weight shifting, obstacle course, walking on different~     grounds were applied to the the study group with visual feedback methods and control group.~   "
19200|NCT03315637|"~     This study aims to assess the feasibility to perform a fetoscopic prenatal repair of an open~     neural tube defect, and secondly to assess the maternal, fetal and neonatal outcomes.~   "
22273|NCT03275493|"~     This is a single center,randomized ,two-cohorts, open-label ,phase 1/2 study to evaluate the~     efficacy and safety of T cells expressing humanized CD19 chimeric antigen receptors treatment~     for relapsed/refractory CD19+ acute lymphoblastic leukemia patients.~   "
19154|NCT03316235|"~     Acetabular fractures are the resultant from high-energy trauma or low-energy trauma in the~     elder patients. Usually, surgeons use LETOURNEL's classification or/and JUDET's one.~      Five elements are considered and associated to five type of fracture. Even more, for~     orthopaedic surgeons with less experience with these fractures, correct classification can be~     more difficult.~      So the the aim of this study is:~        1. Evaluate the efficacy of four special 3D reconstruction: a 3D reconstruction of the~          pelvis with anterior view, posterior view, endopelvic view where the opposite hemipelvis~          removed and an exopelvic view where the femoral head is removed according to the initial~          teaching of E. Letournel.~        2. Evaluate the addition of teaching of non-experimented surgeon on the accuracy of~          classifying acetabular fractures.~        3. Evaluate the addition of a digital algorithm (mobile application) on the accuracy of~          classifying acetabular fractures.~   "
19155|NCT03316222|"~     This is a first in human, open-label dose escalation study to investigate the safety,~     tolerability and pharmacokinetics of GNS561 in patients with advanced malignancies including~     hepatocellular carcinoma.~   "
19156|NCT03316209|"~     Lymphoid hemopathies are a group of malignant haematological disorders characterized by~     clonal proliferation of cells of the lymphoid line. Non-Hodgkin's lymphoma (NHL), chronic~     lymphocytic leukemia (CLL), and multiple myeloma (MM) are the most frequently encountered~     features of lymphoid hemopathies. Duriong the last 35 years the prevalence of these~     pathologies has increased in France but also in most industrialized countries. This increased~     can't be solely explained by demographic changes and improvements in diagnostic techniques.~     As a result, the involvement of environmental and professional factors is strongly suspected.~     Studies have shown that these diseases are associated with some professions or type of~     activity, including agricultural occupations, and other sectors such as agriculture,~     printing, woodworking. Some organic solvents and pesticides have been suspected of being risk~     factors of hematologic malignancies. Based on cohort studies and case-control studies, some~     of them have been identified by the International Cancer Research Center as associated with~     the occurrence of NHL with a sufficient or limited level of evidence. One of the difficulties~     encountered in the analysis of the literature has been the permanent evolution of the~     international classification of lymphoid hemopathies over the past 30 years. The old~     epidemiological studies are therefore difficult to interpret. Lymphoid hemopathies cover a~     range of different conditions, thus it is likely that carcinogens involved vary according to~     the type of hemopathy. Finally, environmental and occupational exposures to various chemicals~     and biological agents have evolved over time. The aim of this study is firstly to develop and~     validate a questionnaire to identify and quantify exposures to nuisances (substances and~     agents) suspected of being associated with the occurrence of NHL, MM and LLC. In a second~     time, this questionnaire will be used as a support for the realization of a subsequent~     case-control study to improve epidemiological knowledge on these diseases.~   "
19157|NCT03316196|"~     Posttraumatic stress disorder (PTSD) is a chronic, disabling condition that occurs in a~     subgroup of individuals after experiencing traumatic stress, and is common in Veterans~     seeking mental health treatment at the VA. Although evidence-based psychosocial treatments~     exist for PTSD, a substantial portion of individuals do not fully respond to treatment. Thus,~     there is a clear need to continue researching novel interventions for PTSD in Veterans.~     Recently, new interventions for mental health disorders have utilized computerized cognitive~     training techniques in order to improve the functioning of cognitive systems and reduce~     symptoms. This type of intervention, often referred to as neurotherapeutics, may hold promise~     for PTSD as a method for ameliorating symptoms and improving cognition. Individuals with PTSD~     demonstrate difficulties with cognitive control functions, which appear to be causally~     implicated in symptoms of the disorder (e.g., intrusive trauma-related memories). To date the~     efficacy of neurotherapeutics for PTSD has been understudied in Veterans.~      The current proposal aims to bridge research on basic neurocognitive mechanisms of PTSD with~     intervention research by conducting a randomized controlled trial (RCT) of a cognitive~     control training program in 80 Veterans with PTSD. Veterans will complete computer-based~     training exercises designed to specifically target and improve aspects of cognitive control.~     Veterans will complete the program twice per week for eight weeks. Symptoms will be assessed~     before and after treatment, as well as at a two month follow up time point. The primary goal~     of the study is to examine the effect of the intervention on PTSD symptoms and cognitive~     deficits. Evaluating symptom change as a result of the intervention will provide critical~     data regarding the utility of this program as a PTSD treatment. If effective, this training~     program could serve as alternative treatment option for Veterans with PTSD, and could be~     translated into an easily transportable intervention for dissemination (e.g., through~     web-based platforms). A secondary goal is to use functional magnetic resonance imaging (fMRI)~     to better understand the mechanisms by which cognitive training culminates in symptom~     reduction. If training cognitive control with neurotherapeutics directly enhances functioning~     of specific neural substrates as hypothesized, improvements in affective processes relying on~     shared neural regions would also be predicted. Modifying functioning in these substrates with~     training may thus reduce symptoms by improving neural functioning while processing and~     managing trauma-related affect and information. Neural systems used for cognitive control~     targeted in the training described (e.g., dorsolateral prefrontal cortex [dlPFC]) are also~     recruited when individuals mentally manipulate emotional information, such as when~     individuals use reappraisal to change the way that they think about negative emotional~     situations or content. In this study, Veterans will complete a neutral cognitive control task~     and a reappraisal task while undergoing fMRI before and after completing the training~     treatment. This will be the first study to evaluate neurobiological mechanisms of this type~     of training in PTSD, which is a fundamental next step for understanding how to improve the~     training program and who may be best served by completing it.~   "
19158|NCT03316183|"~     The purpose of this study is to compare patients' metabolomic profiles who are managed with a~     brain monitor that measures cerebral oxygen to those who are managed by conventional measures~     to hopefully decrease postoperative neurologic and cognitive deficits and improve quality of~     life.~   "
19159|NCT03316170|"~     The objectives of this pilot clinical trial are: 1) To evaluate the feasibility and~     acceptability of a new approach to smoking cessation induction treatment in cancer survivors~     with low social resources, and 2) To assess the effectiveness of said treatment for key~     events in the process of smoking cessation.~   "
19160|NCT03316157|"~     In patients with incurable cancer, general deterioration in their ability to walk, exercise~     and care for themselves is often regarded as an inevitable consequence of this. In 2015,~     Hospice UK published a report advocating Rehabilitative Palliative Care.~      However there is limited robust evidence on which to base this approach. Reviews of the~     literature show limited study numbers but do suggest that rehabilitation may be feasible for~     advanced cancer patients. However key components were not clear and no recommendations could~     be given.~      This trial is designed primarily to test the feasibility of a rehabilitation programme~     (exercise and nutritional supplementation) in advanced cancer patients. Feasibility will be~     the primary outcome measure including rates of recruitment and compliance. Secondary outcome~     measures include impact on physical function, nutritional status, quality of life for~     patients and their carers. We will also assess the health economic impact by assessing~     patient health facility use throughout the trial.~      40 patients with advanced cancer living in the community will be recruited from two hospice~     palliative care teams in Edinburgh. These patients will be randomised in to either the~     treatment arm: the rehabilitation programme plus standard care, or the control arm: standard~     care alone. The treatment arm will consist of an 8 week rehabilitation programme, supervised~     at weekly clinics by a physiotherapist and dietician.~      To minimise contamination the control group will be offered the treatment at the end of the 8~     weeks (waiting list control).~      Measurements will be made for both groups and compared at baseline (week 0), midpoint (week~     5) and endpoint (week 9). Recommendations for a larger UK wide trial will be made from the~     findings of this study.~   "
19161|NCT03316144|"~     The primary objective is to assess the safety and tolerability of JS-001 in subjects with~     recurrent malignant lymphoma, and to evaluate its preliminary efficacy.~      The secondary objectives are to: 1) characterize the single-dose and multi-dose~     pharmacokinetic (PK) profile of JS-001, 2) characterize the immunogenicity of JS-001; 3)~     assess the dose-efficacy relationship of JS-001 single agent, and 4) preliminarily evaluate~     biomarkers associated with the efficacy of JS-001.~   "
19162|NCT03316131|"~     This is a randomized, placebo controlled, double-blind, 2-way crossover study conducted on~     asymptomatic hyperuricemic patients. The core study consists of screening period, 2 treatment~     periods (RDEA3170 + febuxostat + dapagliflozin/placebo) and follow-up visit~   "
19163|NCT03316118|"~     Do ultrasound-guided genicular nerve blocks with 0.5% bupivacaine provide improved knee~     analgesia for patients recovering from total knee replacement surgery compared to saline~     injection?~      Hypotheses:~      The investigators hypothesize that the combination of ultrasound-guided adductor canal block~     (ACB) and genicular nerve block will achieve lower opioid consumption and therefore lead to~     decreased systemic side effects and improved overall satisfaction compared to~     ultrasound-guided saline injection for patients undergoing minimally invasive elective total~     knee arthroplasty (TKA).~   "
19164|NCT03316105|"~     The investigators are doing this research study to find out the effect of T6 Dermatomal~     Electrical Stimulation (delivered by a Transcutaneous Electrical Nerve Stimulation (TENS)~     unit) on stomach motor activity.~   "
19201|NCT03315624|"~     The clinical investigation will be performed to generate clinical data on clearances and~     removal rates (for ß2-microglobulin, myoglobin, phosphate, creatinine, and urea) as well as~     biocompatibility of the modified polysulfone membrane to obtain CE-certification according to~     the European Medical Device Directive for the FX Coral 600 (TD 16-1) dialyzer.~   "
19166|NCT03316079|"~     Critically ill and intubated patients on mechanical ventilation (IMV) often present retention~     of respiratory secretions, increasing the risk of respiratory infections and associated~     morbidity. Endotracheal suctioning (ETS) is the main strategy to prevent mucus retention, but~     its effects are limited to the first bronchial bifurcation.~      Mechanical in-exsufflation devices (MI-E) are a non-invasive chest physiotherapy (CPT)~     technique that aims to improve mucus clearance in proximal airways by generating high~     expiratory flows and simulating cough. Currently there are no studies that have specifically~     assessed the effects of MI-E in critically ill and intubated patients. Thus, the aims of this~     study are to evaluate efficacy and safety of MI-E to improve mucus clearance in critically~     ill and intubated patients.~   "
19167|NCT03316066|"~     The purpose of this study is to compare the efficiency and safety of 2ml versus 5ml of local~     anesthetics used in stellate ganglion blocks for the treatment of complex regional pain~     syndrome of the arm.~   "
19168|NCT03316053|"~     The purpose of this study is to analyze biopsied tissue samples for changes in cells and~     genes involved in Barrett's Esophagus.~   "
19169|NCT03316040|"~     In Zambia, 13% of the 15 to 49 year old population lives with HIV. The highest number of new~     HIV infections is among young people. To counter the spread of the disease, developmental and~     governmental actors are increasingly relying on educational behavior change tools. A~     particularly widely used tool, implemented by the German Development Corporation (henceforth,~     GIZ), is the so-called Join-In-Circuit on AIDS, Love Sexuality (JIC). The tool aims to~     improve a) HIV and sexual reproductive health knowledge, b) HIV testing uptake, and c) demand~     for health services. Previous research has investigated the direct effect of the JIC on~     knowledge about Sexually Transmitted Infections (STIs) as well as self-reported sexual~     behavior in Zimbabwe, and has found positive effects in both domains.~      The research project evaluates the JIC in Zambia. The study randomly assigns 170~     participating schools to five different JIC treatment arms. The first two arms represent~     control schools. Here, no JIC will be implemented. The third arm implements the JIC among a~     random subset of students. The fourth arm implements the JIC among indegree central students.~     The fifth arm implements the JIC among edge betweeness central students. In each school, the~     JIC will be implemented in one pre-determined grade. Within each school at least 30 students~     will be selected. For larger schools, 20 percent of students in the selected grade are~     selected.~   "
19170|NCT03316027|"~     The study aims at determining adherence rate to DMARDS and predicting factors affecting~     treatment adherence among sample of Egyptian patients with RA.~   "
19171|NCT03316014|"~     Aim. — To describe the adverse drug reactions (ADR) and the drugs involved in pediatrics.~      Methods. — An observational study on all ADR notifications recorded in the French~     pharmaco-vigilance database by the Regional Pharmacovigilance Center of Champagne-Ardenne~     between 1 January 1985 and 31 December 2014 involving children from 0 to 17 years inclusive~     was performed. For all notifications, we studied the patient and the ADR characteristics~   "
19172|NCT03316001|"~     Mesenteric panniculitis is a benign inflammatory condition that involves the adipose tissue~     of the intestinal mesentery. Clinical manifestations are uncommon, non specific and atypical.~     Mesenteric panniculitis is thus most often an incidental finding during an investigation for~     other reason, mostly on computed tomography scans. The rate of malignancy in patients with~     mesenteric panniculitis, especially urogenital and gastrointestinal adenocarcinomas or~     lymphomas, has been reported to be as high, thus suggesting that there may be a relationship~     between mesenteric panniculitis and progression of an underlying malignancy or the risk of a~     future malignancy.~   "
19173|NCT03315988|"~     The amount of people with diabetes mellitus has now reached over 4 million in the United~     Kingdom. Type 2 diabetes accounts for the majority of all cases of diabetes and increases the~     risk of many other diseases such as heart problems. Plant based diets are thought to be an~     effective way to improve markers of health related to type 2 diabetes and heart disease. One~     way that a plant based diet improves health could be through reducing waste products that are~     generated in the gut by the bacteria that break down food as part of the digestion process.~     For example, the digestion of some meats, fish and eggs results in the creation of a~     substance called Trimethylamine-N-Oxide (TMAO) which has been linked to worse health outcomes~     in several studies. However, the full impact on TMAO and blood glucose levels of swapping~     regular meat consumption for a plant based vegan diet is not fully understood and requires~     further research. Therefore, the aim of this study will be to develop and undertake a~     clinical trial to investigate the effects of an 8-week vegan diet on TMAO levels and post~     challenge glucose levels in individuals with dysglycaemia (drug naïve).~      The study will be interventional single group prospective trial of adults aged 18-75 years of~     age from a multi-ethnic population with dysglycaemia (drug naïve). A sample of 29 people will~     be sought. The dietary intervention (vegan diet) will last 8 weeks. Then, the participants~     will go back to their normal diet and come for their final visit after a four week follow-up~     period (week 12). To assess the effectiveness of the intervention, primary and secondary~     outcome data collected at baseline will be compared with data collected at 1 week, 8 weeks~     and 12 weeks.~   "
19174|NCT03315975|"~     Influenza vaccination is indicated for all adults, but the immunogenicity of vaccination has~     not been assessed in all situations. We are conducting a prospective unblinded study of~     influenza vaccine recipients.~   "
19175|NCT03315962|"~     The failure to use isoniazid (INH) preventative therapy (IPT) in HIV-infected individuals in~     Sub-Saharan Africa represents one of the single biggest implementation gaps between evidence~     and practice in today's response to the HIV epidemic. The proposed study will evaluate the~     effectiveness of a multi-component intervention to improve IPT uptake across the country of~     Uganda. The overall objective of this study is to determine if a multi-component~     implementation intervention (SPIRIT) that targets District Health Officers (DHOs) can~     increase IPT initiation and completion among HIV-infected persons, and decrease tuberculosis~     (TB) incidence, as compared to country standard practices, in a cluster randomized trial in~     Uganda.~   "
19202|NCT03315611|"~     The objective of this study is to assess the effect of 'Eucerin AtopiControl LOTION' and~     'Eucerin AtopiControl facial cream' on dermal symptoms in patients with Atopic Dermatitis~     (AD) after two 4 h challenges with grass pollen on two consecutive days. In addition, this~     clinical study with exposure of Dactyls glomerate-sensitized Patients with AD shall be used~     to compare the skin response with AD Patients not-sensitized to Dactylis glomerata to~     understand the specificity of the grass pollen exposure.~   "
19176|NCT03315949|"~     Split dose bowel cleansing is recommended method for colonoscopy. For afternoon colonoscopy,~     same-day dose of bowel cleansing is alternative option. Recently, same-day bowel cleansing~     for morning colonoscopy was validated. To date, there was no study which compared the bowel~     cleansing efficacy between same-day dose and split dose regardless of colonoscopy time. The~     aim of current study is to compare the bowel cleansing efficacy, adverse events, and~     patient's tolerability between the two group.~      Subjects who underwent colonoscopy for various reasons were included. After agreeing to~     participate in the study, study participants were randomly assigned to split dose or same day~     dose group. Bowel cleansing is done using polyethylene glycol (PEG). All colonoscopy was done~     between 10 AM to 6 PM. Study participants were instructed to ingest 500ml PEG every 15~     minutes. Subjects who were assigned to split dose group ingested 2L PEG from 9PM 1 day before~     colonoscopy. Remaining 2L PEG was ingested 3-5 hours before colonoscopy. In the same-day dose~     group, bowel cleansing was started from 5AM for subjects who were scheduled to receive~     colonoscopy in the morning. Afternoon colonoscopy group in the same-day dose group ingested~     2L PEG from 5AM. Remaining 2L PEG was finished 3-5 hours before colonoscopy.~      Bowel cleansing efficacy was assessed using Boston bowel preparation scale. Vital signs and~     laboratory tests were checked before colonoscopy. Study participants completed questionnaire~     which contained patient's satisfaction, tolerability, and adverse event during bowel~     cleansing. Bowel cleansing efficacy, patient's tolerability, and safety profile were compared~     between the two groups. Successful bowel cleansing was estimated 85% for split dose group. We~     set 10% for inferior margin. Considering 10% drop out, a total of 352 subjects will be~     recruited.~   "
19177|NCT03315936|"~     This first-in man trial is designed to investigate the safety and tolerability of BI 894416~     in healthy male subjects following oral administration of single rising doses.~      Pharmacokinetics (PK) including dose proportionality after single dosing of BI 894416 will be~     explored.~   "
19178|NCT03315923|"~     The purpose of this study is to compare annualized relapse rate, expanded disability status~     scale, Gad-enhanced brain lesions, and side effects after administration of rituximab and~     glatiramer acetate among patients with active progressive multiple sclerosis during a one~     year follow up through a randomized clinical trial.~   "
19179|NCT03315910|"~     This study is to help determine the most effective type or combination of treatments to offer~     patients seeking lung cancer screening who are smokers to help them reduce the number of~     cigarettes they smoke, or quit smoking. The investigators long term goal is to increase the~     benefits of lung cancer screening by providing a blue print of best practices for screening~     sites to deliver tobacco treatment to their patients who are smokers, in a way that does not~     add burden to screening site staff and increases the chances of patients quitting smoking.~   "
19180|NCT03315897|"~     The present trial consists of 2 sub-studies that investigate important novel aspects of~     treatment with erythropoietin (EPO) on cognitive dysfunction in bipolar disorder (BD). The~     aims of the trial are three-fold. We aim to investigate the effects of 12 weekly recombinant~     human EPO infusions on cognition in (i) healthy first-degree relatives of BD patients~     (substudy 1) and (ii) remitted BD patients (substudy 2), and (iii) explore early~     treatment-associated neural activity changes that may predict subsequent cognitive~     improvement.~      It is hypothesized that:~      i. 12 weekly EPO infusions improve cognition in healthy first-degree relatives and remitted~     BD patients in comparison with saline.~      ii. EPO vs. saline-treated participants will display early cognition-related neural activity~     in the frontal lobes, which will correlate with cognitive improvement.~   "
19181|NCT03315884|"~     According to the recommendations of the Inter-Society Consensus for the Management of~     Peripheral Arterial Disease (TASC II) statement and the Russian guidelines for limb ischemia~     treatment (2010), reconstructive surgery is preferred for type D lesions.~   "
19182|NCT03315871|"~     Background:~      Some people with prostate cancer have a rise in prostate-specific antigen (PSA). This can~     happen even after treatments like radiation and surgery. Androgen deprivation therapy (ADT)~     drugs and close monitoring are one standard way to treat this group of people. Another way is~     to monitor people and their PSA values over time. Researchers want to see if a combination of~     new drugs can help these people.~      Objective:~      To see if the combination treatment of PROSTVAC, CV301, and MSB0011359C (M7824) can induce an~     anti-tumor attack in people with biochemically recurrent prostate cancer.~      Eligibility:~      People ages 18 and older with certain kinds of prostate cancer~      Design:~      Participants will be screened with~        -  Medical history~        -  Physical exam~        -  Blood and urine tests~        -  A scan of the neck, chest, abdomen, and pelvis~        -  A bone scan~      A sample of tissue that was already taken will be tested. This will confirm the diagnosis,~     stage, and disease status.~      Some participants will have close monitoring with four monthly PSA checks.~      All participants will get two study drugs as shots under the skin. They will get the third~     drug in a vein. They will get the drugs over at least 7 months. Their vital signs will be~     checked before they get the drugs and for up to 1 hour after.~      Participants will have frequent study visits. They will have physical exams, urine and blood~     tests, and scans.~      Participants will return to the clinic about 4 weeks after they stop taking the study drugs.~     They will have a medical history, physical exam, and blood tests. They may also have~     long-term follow-up visits.~   "
19183|NCT03315858|"~     Aim of the study is measurement of NFAT-RGE (IL-2 (interleukin-2), IFN-γ (interferon-gamma),~     GM-CSF (granulocyte monocyte colony stimulating factor)) after tacrolimus (TAC) in de-novo~     immunosuppressed patients after liver transplantation (LT), to test the hypothesis that in~     de-novo TAC patients receiving mycophenolate mofetil (MMF) and steroids after LT there is an~     inverse correlation of NFAT-RGE and TAC peak levels at 1.5 hours after TAC intake.~   "
19184|NCT03315845|"~     Neuraxial anaesthesia can be more difficult and associated with more complications if the~     patient's bony landmarks are difficult to palpate. They are more likely to be difficult to~     palpate if a patient has a high Body Mass Index (BMI), (>30kg/m2). The depth that the spinal~     or epidural needle must be inserted is usually longer in these patients with high BMIs. We~     wish to palpate the backs of at least 100 such patients to see how many of them have~     impalpable bony landmarks. We then wish to use ultrasound to measure the distance from skin~     to the posterior epidural complex to discover if this length is longer than the standard~     needle length. If it is longer in the majority of people we study, we will recommend changing~     standard practice to start using a longer needle for all first attempts at neuraxial~     anaesthesia in this patient population.~   "
19185|NCT03315832|"~     Aortic stenosis (AS) is the most frequent valvular heart disease in Western countries, with~     increasing prevalence. Recent guidelines recommend aortic valve intervention (surgical aortic~     valve replacement [SAVR] or transcatheter aortic valve replacement [TAVR]) in severe AS, as~     soon as symptoms or left ventricular (LV) dysfunction occur, in order to improve clinical~     outcome and achieve LV mass (LVM) regression. The highest amount of LVM regression is~     obtained during the first year. Nevertheless, there is heterogeneity in LV remodeling and~     residual LV hypertrophy is associated with poorer postoperative improvement in cardiac~     function and morphology. Incomplete regression of LV hypertrophy at 12 months after SAVR is a~     powerful predictor of adverse outcome. Yet, the use of specific pharmacological therapy to~     improve postoperative LVM regression could be an appealing therapeutic option after aortic~     valve intervention.~      Renin-angiotensin-aldosterone system blockers (RAASb) and more particularly angiotensin-II~     receptor blockers (ARBs) are efficient in reducing LVM in hypertensive patients, as~     emphasized by several meta-analyses. In addition, ARBs improve myocardial relaxation,~     diastolic function, decreased hypertrophy and may have anti-fibrotic effects. In a recent~     retrospective study from our group, RAASb prescription after SAVR was associated with~     increased survival, but confirmation through a randomized trial is mandatory. In a~     prospective randomized single-center study, the use of candesartan was associated both with~     LV and LA remodeling as compared to the conventional management. Nevertheless, these results~     are based on echocardiographic data, which is not the gold standard for the assessment~     cardiac remodeling, and no placebo or active comparator was tested to control the impact of~     ARBs in these patients.~      The primary objective of this Phase II study is to investigate the efficacy of valsartan,~     introduced postoperatively, as compared to placebo, on 1-year changes in indexed LVM, as~     assessed by CMR, in patients undergoing aortic valve intervention (SAVR or TAVR) for AS.~      The secondary objectives are to compare the efficacy of valsartan vs. placebo in terms of~     one-year changes (difference from baseline) in cardiac function and in cardiac morphology,~     one-year exercise capacity and one-year changes in biomarkers related to cardiac function. In~     addition, the assessment of the safety of valsartan will also be considered as secondary~     objective.~      The ARISTOTE trial is a multicenter prospective phase II, randomized, double-blind study~     including patients with the diagnosis of severe AS and indication for valve intervention.~      The active treatment is valsartan, an orally active, potent, and specific angiotensin II~     receptor antagonist.~      Patients will be randomized between 2 groups (valsartan versus placebo) and the treatment~     will be initiated (80 mg daily) at 5±4 days following aortic valve intervention. The~     comparative treatment will be a placebo; tablets of valsartan and placebo have a similar~     appearance and administration mode. Patient in the control group will receive a placebo using~     the same protocol as the valsartan group.~      The patients will be cautiously monitored and any adverse events will be collected. The dose~     will be increased at 160 mg daily 13±2 days after aortic valve intervention and, if well~     tolerated, for the remaining period of the study. The tolerance will be regularly assessed~     and dose adjusted according to a pre-specified algorithm.~   "
19203|NCT03315598|"~     The investigators will evaluate the effectiveness and safety of acupuncture treatment in~     refractory neuropathic pain patients.~   "
19288|NCT03314480|"~     The aim is to prospectively assess the association between clinical parameters and the~     presence of maxillofacial fractures in trauma patients admitted to the emergency department.~     Our hypothesis is that a clinical decision aid of critical parameters reduces unnecessary~     produced CT scans in maxillofacial trauma patients.~   "
22274|NCT03275480|"~     Database of Institut Paoli-Calmettes patients diagnosed with Myelodysplastic Syndromes~   "
19186|NCT03315819|"~     The risk of recurrence and chronic instability after an initial episode of anterior~     glenohumeral dislocation is high, the risk is higher the younger the patient is.~      Most patients with recurrences develop this instability during the first 2 years.~      Several studies have shown that an initial arthroscopic surgical treatment (Bankart~     intervention) decreased the risk of recurrence and therefore of chronic instability, but this~     attitude is not usual in France and none randomized study comparing intervention of~     arthroscopic Bankart and immobilization was published by a French team.~      The primary objective was to evaluate at 2 years the efficacy on the rate of recurrent~     instability of the first-line arthroscopic repair of prior capsulo-labral lesions compared to~     conservative treatment by immobilization for patients under 25 years having an initial~     episode of anterior glenohumeral dislocation~      Material and method : We conducted a randomized controlled, open-label, parallel-group study~     (conservative treatment group by immobilizing VS surgical treatment group) in patients aged~     18 to 25 with anterior glenohumeral primo luxation. Patients were clinically reassessed at 2~     years with functional scores (WOSI, DuplayWalch, DASH), mobility and instability recurrence.~      Hypothesis: reduction of the recurrence rate in the surgically treated group~   "
19187|NCT03315806|"~     Adequate macro and microvascular endothelial function during pregnancy is essential for the~     normal placental development and growing fetus. Beetroot juice (BJ) promotes improvement ins~     this parameters in no-pregnant individuals, however the beneficial effect did not avaliated~     in pregnant. The present study evaluated effects of BJ on macro and microvascular endothelial~     function in pregnant. Twelve pregnant were submitted to BJ and nitrate-depleted juice (PLA)~     interventions. Brachial flow-mediated dilation (FMD) and muscle oxygenation were measured 120~     min after interventions. Urinary nitrate, nitrite were measured at baseline and 120 min after~     interventions.~   "
19188|NCT03315793|"~     The purpose of this study is to determine the efficacy of duloxetine hydrochloride versus~     placebo in the treatment of Japanese children and adolescents with depressive disorder.~   "
19189|NCT03315780|"~     The purpose of this study is to evaluate the glucodynamic effects of dulaglutide in Japanese~     participants with type 2 diabetes mellitus.~   "
19190|NCT03315767|"~     This study evaluates correlation in changes of HVPG-pressure values and stiffness values~     (ARFI) for spleen and liver and flow-volume values in Portal vein in patients with liver~     cirrhosis/Portal Hypertension, respectively, after new-admission of beta-blocker therapy.~   "
19191|NCT03315754|"~     Single center, single-arm, open-label, 60-month follow-up phase IIb clinical trial. Men with~     localized prostate cancer will receive TOOKAD® Soluble VTP under general anesthesia.~      To evaluate the absence of biopsy detectable Gleason grade 4 or 5 prostate cancer tumors~     anywhere in the prostate gland on 12-month, post-treatment biopsy following TOOKAD®~     Soluble-VTP in men with prostate cancer Gleason score 7(3+4).~   "
19192|NCT03315741|"~     This is a phase 1, non-randomized, single-arm, open label, single center clinical trial to~     determine the tolerability and safety of pirfenidone in patients with BOS associated with~     lung GVHD after hematopoietic cell transplant.~   "
19193|NCT03315728|"~     The PATHWAYS for Health Equity research program builds on the 5-year FORGE AHEAD Indigenous~     diabetes quality improvement research program (2013 - 2017).~      PATHWAYS for Health Equity, a 3-year research program (2017 - 2019), is a great opportunity~     to continue our important collaborative diabetes quality improvement research with an~     increasing number of Indigenous partnering communities and researchers and key stakeholders~     (collaborators, policymakers and knowledge-users). Four partnering First Nations communities~     will join the Pathways program to develop community-driven quality improvement initiatives~     championed by a Community Facilitator and supported by a Community Data Coordinator.~   "
19194|NCT03315715|"~     This study is to describe the impact of vaginal reconstruction, including an intraperitoneal~     vaginal vault suspension for pelvic organ prolapse (POP) on pelvic anatomy using dynamic~     magnetic resonance imaging (MRI) of the pelvis.~   "
19195|NCT03315702|"~     As novel agonists of Wnt/β-catenin signaling pathway, R-spondin proteins constitute a class~     of ligands, including R-spondin 1/2/3/4, functioning through their receptors leucine-rich~     repeat-containing G-protein coupled receptor (LGR)4/5/6 to enhance Wnt/β-catenin activity.~     Since Wnt signaling plays pivotal roles in the regulation of many life processes involved in~     embryogenesis and adulthood, R-spondin proteins also take part in cell proliferation,~     differentiation and morphogenesis.For example, in the formation of respiratory~     system，R-spondin 2 is required for normal laryngeal-tracheal and lung morphogenesis，and the~     lack of R-spondin 1 expression results in the absence of duct side-branching development and~     subsequent alveolar formation. In addition, R-spondins show protective effect in tissue~     injury and diseases. R-spondin 1 and R-spondin 3 have been reported to prevent chemotheraphy-~     or radiotherapy-induced mucous membrane lesion. R-spondin 1 attenuates oral mucositis~     contributed by radiotherapy in mouse models and R-spondin 3 potentiates intestinal~     regeneration elicited via gastrointestinal toxic effect of chemoradiotherapy treatment.~     However, whether R-spondin proteins exert salient influence on acute lung injury especially~     induced by mechanical ventilation is deficient. Therefore, this study aims to ascertain the~     implication of R-spondin proteins in the pathology of mechanical ventilation induced lung~     injury through detecting human plasma concentration change of R-spondin 1/2/3/4 after~     mechanical ventilation and interference effects in mouse model, which is helpful for~     prevention and treatment of ventilation induced lung injury.~   "
19196|NCT03315689|"~     The primary objective is to assess the safety, tolerability, pharmacokinetics and~     pharmacodynamics of ATI-50002 Topical Solution compared to vehicle in subjects with AU and~     AT.~   "
19197|NCT03315676|"~     The aim of this study is to collect the data of clinical efficacy and safety after the usage~     of bonoprazon and esomeprazole when the patients take NSAIDs more than 2 weeks and have~     gastrointestinal symptoms who have had gastrointestinal erosions and/or ulcers in the past.~   "
19198|NCT03315663|"~     Sweetch is a personalized mobile-health platform coaching system (mobile phone app) designed~     to promote adherence to physical activity guidelines for people with prediabetes.~   "
19199|NCT03315650|"~     This study evaluates the antithrombotic therapy in patients suffering from atrial~     fibrillation after stent implantation in Germany. Patients prescribed with the novel oral~     anticoagulant Rivaroxaban will be followed up over 14 months for their adherence to the~     medication schedule and for complications that occurred after index PCI.~   "
19204|NCT03315585|"~     This trial is studying the effects and safety in treating patients with local prostate cancer~     with a new IRE device called Composite Steep-pulse Treatment Apparatus. This new device could~     cause cell irreversible electroporation, which leading necrosis of tumor cells. It also has~     the ability to prevent nerve,vessel, urethral and capsule unnecessary injury beside the~     ablation area. Composite Steep-pulse Treatment Apparatus will be used in patients who pass~     inclusion/exclusion criteria. Safety, quality of life, and histopathological analysis of~     prostate speciem will be evaluated in each study patients.~   "
19205|NCT03315572|"~     A range of devices has been developed to administer inhaled therapy for asthma, including dry~     powder inhaler (DPI) devices. ELLIPTA is a DPI that is preloaded with a drug therapy to treat~     asthmatic subjects. The objective of this study is to revise ease of use items developed for~     adults to be appropriate for completion by pediatric subjects in future clinical trials and~     to evaluate the newly developed items in subjects with asthma aged 5 to 11 years and their~     caregivers. This is a cross-sectional, qualitative study that will involve pediatric subjects~     with asthma who are currently using an asthma maintenance inhaler and their caregivers. Two~     rounds of repetitive cognitive interviews will be conducted with 16 subjects in each~     interview set. Each interview will last approximately 45 minutes. Data provided by pediatric~     subjects and their caregivers during interview will be collected as field notes and audio~     recordings which will be transcribed.~   "
19206|NCT03315559|"~     GSK2269557 is being developed as an anti-inflammatory agent for the treatment of chronic~     obstructive pulmonary disease (COPD) and other inflammatory lung diseases such as asthma.~     This study is designed to investigate the recovery, excretion, and pharmacokinetics (PK) of~     (14 Carbon [C])-GSK2269557 administered as a single intravenous (IV) dose (concomitant with~     an inhaled non-radiolabelled dose) and as a single oral dose in 6 healthy male subjects.~     Subjects will receive [14C] radiolabelled GSK2269557 administered as IV infusion, with a~     nonradiolabelled dose of GSK2269557 via dry powder inhaler (DPI) in treatment period 1 and a~     single dose of [14C]-GSK2269557, administered as an oral solution in treatment period 2.~     There will be a washout period of at least 14 days after inhaled and IV dosing before~     subjects takes part in treatment period 2. The IV microtracer dose of GSK2269557 will be~     administered concomitant to an inhaled non-radiolabelled dose to ensure that the~     pharmacokinetics represent a clinically relevant dose. The total study duration will be up to~     11 weeks, including a screening visit, 2 treatment periods and a follow-up visit.~   "
19207|NCT03315546|"~     TEDDI is a non-randomised phase II trial in Scandinavia. All pediatric patients, referred for~     radiotherapy in the thorax or abdomen and irrespective of diagnosis, are eligible.~      Deep inspiration breath-hold (DIBH) is a simple radiotherapy technique, which could have a~     dramatic impact on the risk of late effects in children. In DIBH, the radiotherapy is~     delivered while the patient holds his/her breath (4-6 sequential breath-holds). The anatomy~     is changed and imaging artifacts from respiratory movement are diminished. DIBH is widely~     used in adult patients with breast cancer and mediastinal lymphoma to minimize the risk of~     radiation-induced late effects due to a reduced dose to the healthy organs. Also, the~     technique is simple and cost-efficient.~      For pediatric patients, the investigators aim to:~        -  Estimate the dosimetric benefit of radiotherapy using DIBH compared to free-breathing~        -  Establish the compliance of DIBH~        -  Determine if DIBH is an accurate and reproducible strategy~        -  Optimize treatment planning considering the risk from loss of tumour control as well as~          the risk of late effects.~   "
19208|NCT03315533|"~     The current way that pain is treated after trauma and injury is problematic. Most often pain~     after trauma is treated with opioids (ex. Percocet® or Vicodin®) or anti-inflammatories (ex.~     ibuprofen). Both of these medications can cause side effects and opioids have been related to~     the development of addiction. In addition, there are not any treatments that prevent pain~     from going on to become persistent (last beyond it is supposed to) or chronic (lasting 3~     months or longer).~      Chronic pain is an enormous problem and there an urgent need to find both alternatives to~     opioid pain medications and medications that prevent pain from becoming chronic. The~     ATTAC-Pain (Altering The Transition from Acute to Chronic Pain) study proposes to examine~     whether duloxetine (a medication that is marketed for depression, anxiety, and specific types~     of pain conditions), can reduce acute and chronic pain among adults who come to the emergency~     department (ED)with muscular pain (such as neck pain after a car accident or low back pain).~     Investigators will enroll 60 patients who come to the ED. Patients will be eligible if they~     report moderate to severe muscular pain (such as pain in the back, neck, or shoulders).~     Consenting patients will be randomized to receive duloxetine 30mg, duloxetine 60mg, or~     placebo (2/3rd chance of being in one of the duloxetine groups). The study team will follow~     patients for six weeks and collect information on pain outcomes and use of pain medications.~     Investigators aim to determine if duloxetine can (1) reduce acute pain symptoms following the~     ED visit, (2) prevent the transition to persistent pain (having pain 6 weeks after the~     initial ED visit), and (3) decrease opioid use following a motor vehicle collision (MVC). The~     results of this study will ultimately help determine if duloxetine can be used as a~     non-opioid pain treatment option that reduces acute pain and prevents the transition to~     chronic pain. This in turn can improve recovery, reduce opioid use and its consequences, and~     decrease health care costs.~   "
19209|NCT03315520|"~     Nowadays there is no randomized trials for comparison the effectiveness and tolerability of~     different conditioning regimens.~      Bendamustine is a unique chemotherapeutic agent that combines alkylating action of nitrogen~     mustard and the activity of purine antimetabolite. Bendamustine has shown its effectiveness~     for the treatment of patients with chronic lymphoproliferative diseases such as chronic~     lymphocytic leukemia and several indolent lymphomas. The literature also presents evidence of~     the effectiveness bendamustine in patients with Hodgkin's lymphoma who received multiple~     lines of prior chemotherapy, including high dose chemotherapy and transplantation of~     peripheral hematopoietic stem cells. There are also data of using bendamustine as a part of~     conditioning regimen.~      In this context, it was planned a study for evaluation the safety and effectiveness of the~     BeEAC (bendamustine, etoposide, cytarabine, cyclophosphamide) conditioning regimen prior to~     autologous transplantation of peripheral hematopoietic stem cells for the treatment of~     relapsed/refractory malignant lymphomas.~   "
19210|NCT03315507|"~     PB1046-PT-CL-0005 is an open-label, dose-titration study to assess the safety, tolerability,~     and hemodynamic effects of individually dose-titrated PB1046 administered by weekly~     subcutaneous injection for 8 weeks in adult subjects with PAH who have a permanently~     implanted hemodynamic monitor in the distal pulmonary artery. The primary objectives of the~     study are to assess the overall safety, tolerability, and hemodynamic profile of a PB1046~     across an individually titrated dose range.~   "
19211|NCT03315494|"~     This double-blind, placebo-controlled, multiple ascending dose study is designed to evaluate~     the safety, tolerability, and pharmacokinetics (PK) of SKI-O-703 in healthy volunteers.~   "
27149|NCT03211637|"~     Evaluate the process for implementing a wound protocol for lesion control and~     cost-effectiveness in the context of the Family Health Strategy in the city of Santa Cruz do~     Sul, Brazil.~   "
19212|NCT03315481|"~     This is a randomized clinical trial in healthy volunteers. 12 volunteers will have~     suture-method catheters placed in the adductor canal of each leg using the long-axis plane~     and short-axis plane technique. The investigators will inject LA in both catheters to confirm~     correct position. Following return of cold sensation the catheter is then displaced~     intentionally. The orifice is identified by injection of isotonic saline to ensure a proper~     displacement (spread outside of the adductor canal) and the distance from the delivery~     orifice of the catheter to the adductor canal is noted. A second investigator will assess~     distance from the LA delivery orifice of the catheter to the adductor canal using~     hydrodissection with isotonic saline to pinpoint the delivery orifice and subsequently~     reposition the catheter to obtain LA spread within the adductor canal. Successful~     repositioning is defined as a combination of LA spread within the adductor canal and loss of~     cold sensation on the medial part of the lower leg.~   "
19213|NCT03315468|"~     With a high incidence, low survival rates and limiter availability of effective treatment,~     melanoma is one of the research priorities for health authorities. Optimizing the development~     of both academic and private research requires the availability information on the features~     of patients.~      To meet this need, the French Multidisciplinary Melanoma Group (GMFMel) in collaboration with~     INCa (French National Cancer Institute), the CeNGEPS (National Centre for Healthcare Products~     Trial Management) and the CIC-BT0503 from Nantes University Hospital (Biotherapy Clinical~     Centre of Investigation) has set up in April 2011 a Clinical Investigation Network for~     melanoma, called the CeNGEPS-GMFMel network. Nowadays, the network is named :~      RIC-Mel : network for Research and Clinical Investigation on Melanoma. Aims of the network~     are to promote translational and epidemiological projects as well as to optimize the~     achievements of clinical trials.~      To achieve these goals, a database was launched in 2012 that gives a permanently updates~     mapping of melanoma treated in France with the key information needed for any research~     projects.~   "
19214|NCT03315455|"~     This randomized, multicenter, open-label, Phase 3 study is designed to investigate the~     efficacy, safety, and pharmacokinetics of emicizumab in participants with hemophilia A~     regardless of factor VIII (FVIII) inhibitor status. Participants who received episodic~     therapy with FVIII or bypassing agents prior to study entry and experienced at least 5 bleeds~     over the prior 24 weeks will be randomized in a 2:2:1 ratio to the following regimens: 1)~     Emicizumab prophylaxis at 3 milligrams per kilogram (mg/kg) every week (QW) subcutaneously~     (SC) for 4 weeks, followed by 1.5 mg/kg QW SC; 2) Emicizumab prophylaxis at 3 mg/kg QW SC for~     4 weeks, followed by 6 mg/kg every 4 weeks (Q4W) SC; 3) No prophylaxis (control arm).~   "
19215|NCT03315442|"~     Background & Purpose: Energy drinks consumption continues to grow since its appearance in the~     United States in 1997. Available evidence indicates that caffeine, their main ingredient, can~     alter the central nervous system (CNS). However, it is unknown how energy drinks adjust the~     CNS postural control mechanism. The purpose of this study was to investigate how energy~     drinks can affect postural control after sensory perturbations during stance.~      Methods: 20 healthy adults, (11 males; 9 females) averaging 26.1 years of age, stood on a~     pressure mat, which measured center of pressure (CoP), anteroposterior (AP) and mediolateral~     (ML) postural sways during eight different balance tests (BALT's). BALT's were designed to~     alter or cancel the systems involved in postural control: visual, vestibular and~     somatosensory. Subjects were randomly assigned to a caffeine group and an energy drink group.~     MANOVA analysis was performed for all variables of interest.~   "
19216|NCT03315429|"~     Background:~      Chronic heart failure (HF) is frequently accompanied by functional mitral regurgitation (FMR)~     caused by left ventricular (LV) remodeling and subsequent papillary muscle displacement~     resulting in mitral valve (MV) leaflet tethering, dilatation and flattening of the mitral~     annulus and reduced closing forces. Up to moderate FMR affects the majority of patients with~     systolic heart failure - roughly 80% - still independently increasing mortality. Every fifth~     patient with chronic heart failure experiences a progression of FMR during the first three~     years of follow up despite guideline directed heart failure therapy, which is independently~     associated with a poor prognosis. Furthermore, MR is well known to have a strong dynamic~     component not only during the cardiac cycle at rest and with exercise.~      Aims of the study:~      The investigators therefore aim to assess whether stress tests in patients with functional~     mitral regurgitation unmasks significant dynamic mitral regurgitation or might aid to~     identify patients at risk of FMR progression in patients with functional mitral regurgitation~     in heart failure with reduced ejection fraction (HFrEF) under guideline directed medical~     therapy.~      Study design:~      The investigators will prospectively perform stress tests in all patients with non-severe FMR~     that are routinely seen in the heart failure outpatient clinic.~      Study patients:~      Patients with stable chronic heart failure on optimal medical therapy, who undergo routine~     ambulatory clinical control visits in the heart failure outpatient ward of the Medical~     University of Vienna, will be included in the present study. A written informed consent will~     be obtained before inclusion. Inclusion criteria will be a non-severe FMR, an age of at least~     18 years and stable heart failure related medical therapy in the last 3 months.~      Methods:~      All patients that are willing to participate will undergo stress testing (i.e. volume~     challenge and low dose dobutamine stress) to determine whether patients display severe~     dynamic FMR under stress conditions. Within the registry patients will be followed-up during~     routine ambulatory visits for three years. Patients with severe dynamic functional mitral~     regurgitation will be compared to patients without severe dynamic FMR. Record of clinical~     events during the FUP will be performed. Routine laboratory parameters, have been measured at~     inclusion. Additionally, neurohormone patterns will be measured at baseline and at peak~     stress.~      Sample size:~      Expecting a prevalence of severe dynamic FMR of 20%, the investigators would include a total~     of 150 chronic heart failure patients taking also into account a study-dropouts of 20% ( loss~     of follow-up and mortality).~   "
19217|NCT03315416|"~     This study will look at whether there is a relationship between how babies are fed, whether~     they suck a dummy/hand and how they develop speech.~   "
19218|NCT03315403|"~     The purpose of this study is to evaluate the added diagnostic value of a quantitative~     polymerase chain reaction targeting the lytA gene in detecting pneumococci in patients with~     community-acquired pneumonia.~   "
19219|NCT03315390|"~     During the PICTURE trial a short narrative therapy (narrative exposure therapy adapted for~     primary care) for patients with posttraumatic stress disorder (PTSD) after intensive care~     treatment is to be carried out by their general practitioner (GP). During regular practice~     hours, this is often difficult. For this reason, we are investigating whether the regular~     treatment can be improved by a specially trained GP.~      The aim of the study is to investigate the efficacy and applicability of a short version of~     an established narrative therapy for patients with posttraumatic stress disorders after~     intensive medical treatment.~      Three months after discharge from the intensive care unit, the diagnosis of a PTSD symptoms~     is verified and the patients are randomized into two groups.~      In the treatment group, the physician will perform three 45-minute therapy sessions with the~     patient within 6 weeks. During the first session a list of the most intense events - both~     positive and negative - in the life of the patient is drawn on the basis of a life line, with~     the stay at the intensive care unit being one of these events. The second session deals with~     the experience during intensive care in detail, led by the GP. During the third session,~     another event from the patient's life will be discussed in the same manner. This way, the~     different components (cognitions, emotions, body reactions, context information) can be~     reconnected and classified into the patient's own biography. Between the therapy sessions, a~     conversation between the GP and the psychologist will take place to support the GP during the~     therapy. In order to monitor the patient's safety and compliance, standardized telephone~     calls between the patient and the GP practice are regularly carried out every 2-3 weeks in~     between therapy sessions up to the first data collection after 6 months (T1).~      In the control group there are three doctor-patient contacts, too, which content is based on~     the patient's symptoms. This group thus receives the standard therapy which is customary in~     practice.~   "
19220|NCT03315377|"~     Hypothesis: Lunate-capitate-fusion (LCF) results in comparable outcome (i.e. not worse) to~     four-corner-fusion (4CF) for Scaphoid Nonunion Advanced Collapse (SNAC) and Scapholunate~     Advanced Collapse (SLAC) arthritis regarding functional results (grip strength).~      Design: Prospective randomised comparison. Inclusion criteria: SNAC or SLAC arthritis~     requiring a salvage procedure (grade 2-3).~      Exclusion criteria: SNAC or SLAC arthritis grade 4 (panarthritis). Inability to co-operate~     with the follow-up protocol (language difficulties, severe psychiatric disorder or drug~     addiction).~   "
19221|NCT03315364|"~     To compare and evaluate the efficacy and safety of Liporaxel® solution (oral paclitaxel) and~     Taxol® (IV paclitaxel) on recurrent or metastatic breast cancer.~   "
19222|NCT03315351|"~     Interventional, exploratory, prospective and monocentric study which aim to study the~     feasibility of brachytherapy using a PET-scan~   "
19223|NCT03315338|"~     This initial Phase I study will evaluate the safety, tolerability, and pharmacokinetic (PK)~     of single and multiple ascending doses of CORT118335, the effect of concomitant~     administration with food on exposure to CORT118335, and its pharmacological effect in healthy~     subjects.~   "
19224|NCT03315325|"~     The present study was designed to assess the responsiveness of the hypothalamic pituitary~     gonadal axis to kisspeptin administration with increasing age in men.~   "
19225|NCT03315312|"~     Occlusal caries management in first permanent molars: a pragmatic randomized clinical trial~     in child dental care~      Aim of the present study is to evaluate the effectiveness of fissure sealants and fluoride~     varnish in a pragmatic randomized clinical trial and evaluate whether some specific patient~     groups benefit more from any particular treatment.~      The high risk children (having a previous caries experience at 5 years of age) from 2009,~     2010 and 2011 birth cohorts (6-, 7- and 8-year-olds) from three counties (Østfold, Oppland~     and Hedmark) are selected. Children with at least two erupted first permanent molars in the~     same jaw randomly receive resin-based sealant or a fluoride varnish (Duraphat) during a~     routine dental examination. Children who already developed caries, had restorations or~     fissure sealants placed in first molars were excluded from the present study.~      Fluoride varnish and resin-based fissure sealants are randomly applied on contra-lateral~     teeth where each child serves as its own control. This study uses a natural clinical setting,~     where clinicians use methods and procedures that are routinely applied in public dental~     clinics. The study is approved by the Regional Committee for Medical Research Ethics South~     East (2016/2002/REK sør-øst C).~      Sample size calculations: Based on the assumption that 80% of the treated teeth do not get~     caries and that 10% difference in caries development constitutes a clinically meaningful~     difference, it is required to recruit 180 participants in the study for the split-mouth~     design. Considering a potential maximum of annual 20% drop-out rate and a 3-years follow-up,~     the study will need to recruit 400 participants in order to have at least 206 children at the~     3 years of follow-up.~      Treatments are provided by either dentists or dental hygienists during routine dental~     examinations. Caregivers of eligible children are informed about the study, the participation~     is voluntary and an informed written parental consent is obtained in accordance with the~     directions of the Regional Committee for Medical Research Ethics. In this study, a clinician~     selects a random treatment for the first tooth by choosing one of the two cards, while a~     collateral tooth receives an alternative treatment. Subsequently, treatments provided and~     materials used are recorded on a treatment registration form. During this study, clinicians~     follow their conventional clinical procedures for applying sealants or fluoride varnish.~     Information on patient's caries experience and quality of oral hygiene are recorded on~     treatment registration form. Fluoride varnish is applied three times, at baseline, 6 months~     and 12 months.~      Caries on occlusal surfaces of first molars detected at later 24 and 36 months follow-ups~     will be recorded in the follow-up registration form. The main study outcome is caries~     occurrence on occlusal tooth surfaces.~   "
19226|NCT03315299|"~     The purpose of this study is to provide expanded access to ASP2215 for a single subject with~     refractory FLT3-mutated AML without access to comparable or alternative therapy.~   "
19227|NCT03315286|"~     This study will evaluate the safety and effectiveness of Shade for the management of~     UV-induced skin complications and data collected from this study will be used to support the~     proposed indications for use.~   "
19228|NCT03315273|"~     1. Validation of translated Motor Imagery ability questionnaire MIQ-RS~        2. Investigating the Motor Imagery ability in patients with traumatic brain injury~   "
19229|NCT03315260|"~     This study aims to answer the research question: Are Japanese bone metastatic CRPC patients~     satisfied with their Ra-223 treatment, and what factors drive such satisfaction? It also aims~     to determine patient anxiety regarding prostate cancer while on treatment with Ra-223, and~     assess the effect on quality of life.~   "
19230|NCT03315247|"~     Bariatric (weight loss) surgery is the most effective treatment for extreme obesity, but~     surgery does not treat underlying psychological and behavioural issues. Currently,~     psychotherapy (talk therapy) for eating problems is not routinely offered with surgery, and~     many people start to regain weight one year later. Objective: This study will examine if~     adding a convenient and accessible psychotherapy by phone one year after surgery will lead to~     increased weight loss two years after surgery. Primary Hypothesis: Relative to the Control~     group (who will get routine care), the group of individuals who get psychotherapy will have~     lower weights 2 years after surgery. Secondary Hypotheses: Relative to the Control group, the~     psychotherapy group will report significantly less maladaptive eating behaviours and medical~     burden, and significantly greater quality of life. Method: Participants recruited from the~     Bariatric Surgery Programs at Toronto Western Hospital will be randomly assigned to 1 of 2~     groups: 1) Control (Usual Standard of Care) or 2) Tele-CBT (a 7-session telephone-based~     cognitive behavioural therapy [a type of talk therapy] intervention focused on developing~     coping skills to improve maladaptive thoughts, emotions, and eating behaviours, specifically~     designed for bariatric surgery patients, delivered 1 year post-surgery). They will have their~     weight measured and will complete measures of eating behaviour and quality of life prior to~     the intervention, and again at several time points extending to 2 years post-surgery.~     Implications: If Telephone-Cognitive Behavioural Therapy (CBT) is found to improve bariatric~     surgery outcomes, it could become the standard of care in Canadian bariatric surgery programs~     and beyond, and be routinely offered to patients who cannot feasibly attend CBT sessions due~     to physical or practical barriers.~   "
19231|NCT03315234|"~     The purpose of the research project is to investigate the potential association of 6 genetic~     polymorphisms with the complexity and the severity of coronary artery disease (SYNTAX score).~     The aim of the study is to combine genetic, clinical and laboratory data in order to create a~     prognostic tool that will enable an individualized therapeutic patient approach.~   "
19246|NCT03315026|"~     Autologous stem cell transplant is beneficial to patients who are diagnosed with multiple~     myeloma or systemic amyloidosis. However, undesired symptoms such as weakness, fatigue,~     nausea, pain and sleep disturbance after transplant can contribute to complications and~     increase the how long the patient is in the hospital, especially in patients age 60-75.~     Research has shown that the development and the intensity of these symptoms are closely~     associated with an increase in a protein called a cytokine which is involved in the~     inflammatory response in the human body. One of the cytokines is called Interleukin-6 or~     IL-6.Therefore, this study will investigate if blocking IL-6 with an agent called siltuximab,~     administered before and after transplant, will decrease the symptom burden after transplant~     to improve quality of life and recovery in the immediate post-transplant period.~   "
19316|NCT03314116|"~     As part of the proposed work, the investigators would like to examine whether there is a need~     to use a training video to train IDF combat soldiers to improve the use of ear plugs and to~     prevent hearing loss from exposure to noise, and to characterize the hearing impaired~     epidemiology of recruits and the basic rate of hearing loss During basic training.~   "
19232|NCT03315221|"~     Preterm birth (birth before start of the 37th week of gestation) is a major determinant of~     neonatal morbidity and mortality and has long-term adverse consequences for health and~     neurodevelopment.~      Preterm infants have much higher nutrient requirements than term infants. The preferred~     nutrition for all infants including preterm infants is human milk from the infant's own~     mother, or alternatively donor human milk, provided it is fortified with several nutrients as~     human milk alone does not sufficiently meet the nutritional needs of preterm infants.~      Human milk fortifiers (HMFs) are multicomponent enrichments that can be added to human milk~     (own mother´s milk or donor milk) to meet the increased nutritional needs of preterm infants.~     The current Nutricia HMF (control product) has been available in its current composition~     since 2010. It is a multicomponent HMF providing protein, energy, minerals, and vitamins in~     accordance with the ESPGHAN recommendations.~      Recent investigation suggests positive effects on growth and development of preterm infants~     when lipids are added to their nutrition. Therefore, Nutricia has added lipids to their HMF~     (test product) for a nutritionally more complete fortification of human milk aiming for~     optimal growth and optimal cognitive and brain development.~      The Renoir study will investigate the difference between both HMFs with regards to the growth~     velocity as well as the safety and tolerance of the new HMF.~   "
19233|NCT03315208|"~     The overall aim of this pilot study is to conduct a preliminary trial to evaluate the~     acceptability and feasibility of adding a transdiagnostic, emotion-focused group intervention~     (the Unified Protocol, UP) to treatment as usual (TAU) in a comprehensive outpatient program~     for adolescents and young adults with substance use disorders and emotional distress. Only~     patients seeking services or engaged in care at an existing outpatient program at MGH (the~     Addiction Recovery Management Service) are eligible for participation.~   "
19234|NCT03315195|"~     Surgical outcome is associated the nutritional status of the patients. Perioperative~     nutritional supplement for malnutritional patient were recommended. There are several~     guidelines were recommended the perioperative nutrition for malnutrition patients. But in our~     hospital, there are no consensus guideline applied for the clinical practice. The nutritional~     supplement was judged by only attending physical This study was conducted to comparing the~     perioperative nutritional supplement with oral supplement with conventional approach with~     only dietary advice alone for all patients who undergoing major gastrointestinal surgery.~   "
19235|NCT03315182|"~     Open-label, dose-escalation clinical trial of rAAV9.CMV.hNAGLU injected intravenously through~     a peripheral limb vein~   "
19236|NCT03315169|"~     The aim of this trial is to compare internal wound packing to no packing in postoperative~     management following incision and drainage of perianal abscess. Participants will be~     randomised 1:1 to either the packing or non-packing arm.~   "
19237|NCT03315156|"~     Detection of taste changes in Acute Otitis Media (AOM) patients.~   "
19238|NCT03315143|"~     Primary Objectives:~      To demonstrate that, when compared to placebo in patients with type 2 diabetes (T2D),~     cardiovascular (CV) risk factors, and moderately impaired renal function, sotagliflozin:~        -  Does not increase the risk of cardiovascular events including death from cardiovascular~          disease, non-fatal heart attack and non-fatal stroke;~        -  Reduces the risk of death from CV disease or hospitalization for heart failure.~      Secondary Objectives:~        -  To demonstrate that, when compared to placebo in patients with T2D, CV risk factors, and~          moderately impaired renal function, sotagliflozin:~        -  Reduces cardiovascular events including death from cardiovascular disease, non-fatal~          heart attack and non-fatal stroke;~        -  Reduces risk of progression of kidney disease;~        -  Reduces cardiovascular events including death from cardiovascular disease and emergency~          treatment for heart failure;~        -  Reduces death from cardiovascular disease;~        -  Reduces death from any cause.~        -  To assess the safety and tolerability of sotagliflozin.~   "
19239|NCT03315130|"~     The purpose of the study is to evaluate the safety and efficacy of RA101495 in patients with~     generalized Myasthenia Gravis (gMG). Subjects will be randomized in a 1:1:1 ratio to receive~     daily SC doses of 0.1 mg/kg RA101495, 0.3 mg/kg RA101495, or matching placebo for 12 weeks.~   "
19240|NCT03315104|"~     Influenza, or the flu, is an infectious respiratory disease that can range in severity from~     mild to severe to even death. This study aims to evaluate a treatment for people who are~     hospitalized with the flu. The study is looking to see if antibodies collected from people~     who have recovered from the seasonal flu or who have had the seasonal flu shot can be used~     safely as a study drug to treat hospitalized patients with severe flu infections. Also, this~     study will help to find the right dose for this study drug for treatment of severe flu in~     hospitalized patients. Overall, this study will evaluate if the hospitalized patients~     receiving standard of care along with the study drug get better more quickly than those~     treated with standard of care and placebo. The study drug that contains antibodies against~     the flu is called anti-influenza immune globulin intravenous (FLU-IGIV).~   "
19241|NCT03315091|"~     The purpose of this study is to assess the effect of food on the pharmacokinetics (PK) of a~     single dose of AZD1775 (printed capsules) in patients with advanced solid tumours.~   "
19242|NCT03315078|"~     The purpose of this study is to evaluate the safety and effectiveness of lentiviral gene~     transfer treatment at restoring immune function to participants with X-linked severe combined~     immunodeficiency (XSCID) who are 2 to 40 years of age, and have significant impairment of~     immunity.~   "
19243|NCT03315065|"~     The goal of this study is to determine the feasibility and efficiency of incorporating 19F MR~     functional lung imaging into the routine assessment of lung cancer patients prior to thoracic~     radiotherapy.~   "
19244|NCT03315052|"~     Our hypothesis is that budesonide will provide effective hepatic ISP that will replace~     prednisone and allow lower systemic drug levels of FK, thus reducing the steroid- and~     calcineurin-associated complications often observed in the OLT population. This study is~     intended to investigate the therapeutic potential of this ISP combination.~   "
19245|NCT03315039|"~     This is a multi-center, open-label, dose escalation study that will determine the maximum~     tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of liposomal annamycin as a single~     agent for the treatment of subjects with AML that is refractory to or relapsed after standard~     induction therapy~   "
27150|NCT03211624|"~     This is a prospective, multi-center, case-control study where neurocognitive function will be~     evaluated in 36 patients with Cushing syndrome (CS) and 36 controls matched for age, gender~     and education.~   "
19247|NCT03315013|"~     In its 2017 revision of the global guidelines for HIV care and treatment, the World Health~     Organization called for rapid or same-day initiation of antiretroviral treatment (ART) for~     eligible patients testing positive for HIV. In sub-Saharan Africa, where most HIV patients~     are located, studies continue to document high losses of treatment-eligible patients from~     care before they receive their first dose of antiretroviral medications (ARVs). Among~     facility-level reasons for these losses are treatment initiation protocols that require~     multiple clinic visits and long waiting times before a patient who tests positive for HIV is~     dispensed an initial supply of medications. Simpler, more efficient, accelerated algorithms~     for ART initiation are needed, including strategies for rapid initiation in patients with~     symptoms of tuberculosis, most of whom do not have active TB.~      In July 2017, the original SLATE study (SLATE I) completed enrollment in South Africa. One of~     the most striking findings of the study so far is the large proportion of patients who~     screened out of the SLATE algorithm and were referred for additional services rather than~     started on ART immediately. Among 298 patients assigned to the intervention arm and evaluated~     for immediate treatment eligibility under the SLATE algorithm, 149 (50%) screened out, two~     thirds of these (100/149) due to symptoms of TB. The vast majority of the TB suspects~     (93/100, 93%) tested negative for active TB.~      The SLATE II study will revise the original SLATE algorithm to provide a pathway for~     immediate ART initiation for some patients with TB symptoms. Under SLATE II, patients with TB~     symptoms will be clinically evaluated by the study nurse and will receive a urine point of~     care LAM (lipoarabinomannan antigen of mycobacteria) test. Those with milder symptoms and a~     negative LAM test will be offered immediate ART. Those with more serious symptoms and/or a~     positive LAM test will be asked to return the next day to receive TB test results and either~     immediate ART or TB treatment. All intervention arm patients (symptomatic and asymptomatic)~     will be asked for a sputum sample for Xpert testing, and positives will be contacted on the~     next day. The SLATE II algorithm will also incorporate other improvements identified from~     SLATE I.~   "
19248|NCT03315000|"~     The study will assess the degree of bronchoprotection provided by the ultra long-acting beta2~     agonist vilanterol against methacholine-induced bronchoconstriction.~   "
19249|NCT03314987|"~     Carnosine is a naturally occurring peptide found in high levels in skeletal muscle and the~     brain and is also available commercially as a dietary supplement. Since carnosine has~     anti-oxidant properties and air pollution exposure induces a state of oxidative stress, the~     purpose of this study is to see if those taking carnosine as a dietary supplement are~     protected from air pollution-induced oxidative stress and adverse cardiovascular outcomes.~   "
19250|NCT03314974|"~     This is a Phase II study of allogeneic hematopoietic stem cell transplant (HCT) using a~     myeloablative preparative regimen (of either total body irradiation (TBI); or,~     fludarabine/busulfan for patients unable to receive further radiation). followed by a~     post-transplant graft-versus-host disease (GVHD) prophylaxis regimen of post-transplant~     cyclophosphamide (PTCy), tacrolimus (Tac), and mycophenolate mofetil (MMF).~   "
19251|NCT03314961|"~     Lymph node status is of major prognostic importance in non-metastatic rectal cancer. For~     oncological reasons, central arterial ligation of the inferior mesenteric artery (IMA) is~     suggested. However, there is no conclusive evidence presented for this procedure.~      This study aimed at investigating the localisation of lymph node metastases and the role of~     central versus peripheral arterial ligation of in rectal cancer specimens.~   "
19252|NCT03314948|"~     The Researchers are trying to determine if Costoclavicular brachial plexus block (CCBPB) can~     be successfully performed in patients with a body mass index greater than thirty.~   "
19253|NCT03314935|"~     The purpose of this open-label nonrandomized Phase 1/2 study is to evaluate INCB001158 in~     combination with chemotherapy in participants with advanced/metastatic solid tumors.~   "
19254|NCT03314922|"~     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of~     INCB050465 in the treatment of Japanese participants diagnosed with previously-treated B-cell~     lymphoma.~   "
19255|NCT03314909|"~     HeSAPP is a single-center, non-blinded, parallel-group randomized controlled trial studying~     the hemopurification strategy for acute paraquat(PQ) poisoned patients. The intervention to~     be investigated include hemodialysis (HD), hemoperfusion (HP), combined~     hemoperfusion-hemodialysis concurrent therapy (HP-HD) and conservative therapy. The object of~     the present trial is to investigate whether hemopurification therapy can reduce mortality~     compared with conservative therapy.~   "
19256|NCT03314896|"~     The purpose of this study is to compare the short- and long-term survival of laparoscopic~     surgery and conventional open surgery for T4 colon cancer~   "
19257|NCT03314883|"~     Mortality of acute hypoxic - hypercapnic respiratory failure (ARF) patients underwent~     invasive mechanical ventilation is demonstrated to be higher than in patients who underwent~     only non invasive mechanical ventilation (NIV).~      There is an increased need to detect more predictive factors for NIV failure, in order to~     better identify patients most at risk of facing negative outcomes.~      The aim of this experimental pilot study is to evaluate the feasibility of the ultrasound of~     diaphragm in ARF patients underwent non invasive mechanical ventilation ( primary endpoint ).~      Furthermore the secondary aim is to observe any relationship between diaphragmatic function~     (excursion), diaphragmatic thickening and the timing of arterial blood gases (ABGs)~     compensation in patients with ARF undergoing NIV treatment; additional outcomes are:~     correlation with dyspnea level, time of mechanical ventilation, NIV failure, rate of~     tracheostomy, length of stay in ICU and in-hospital and 90-day mortality.~   "
19258|NCT03314870|"~     Breast cancer is the most frequent cancer in women. It is often treated with neoadjuvant~     chemotherapy, administered before surgical resection. Unfortunately, many patients do not~     respond to this treatment, or only respond partially. Clinicians therefore need predictive~     biomarkers of treatment response. Thanks to an innovative technique, called CATS, this study~     aims at identifying blood and tissue biomarkers which are predictive of response to~     chemotherapy.~   "
19259|NCT03314857|"~     To evaluate the safety and effectiveness of the SAPIEN XT (Edwards Lifesciences, Irvine,~     California) transcatheter heart valve implantation (TAVI) in Chinese patients with~     symptomatic severe calcific aortic stenosis who are considered at high risk for surgical~     valve replacement.~   "
19281|NCT03314571|"~     There is a trend to offer personalized care in many medical domains. In the field of labor~     pain, it appears that maternal satisfaction about care is multifactorial, and that labor pain~     is only one of its determinants, competing with psychological and sociological factors.~     Furthermore, labor pain is also multifactorial, depending on predisposition to pain, the way~     analgesia is conducted, and other environmental factors. We wish to develop predicting models~     of maternal satisfaction, in order to offer in the future a better tailored analgesia.~   "
19282|NCT03314558|"~     The purpose of our study is to assess the impact of pulmonary rehabilitation on objective~     sleep quality in COPD patients.~   "
19283|NCT03314545|"~     Clinical evaluation of Laminate veneers with coronal post versus post and core foundation~     restoration with single crown for restoration of endodontically treated anterior teeth~     (Randomized Controlled Trial) In-vivo Study~   "
19260|NCT03314844|"~     Glucagon-like peptide-1 (GLP-1), produced mainly in enteroendocrine cells, participates in~     energy homeostasis and glucose metabolism by regulating islet hormone secretion,~     gastrointestinal motility, and food intake, making GLP-1 agonist a treatment for diabetes and~     obesity. Pre-clinical and clinical studies have demonstrated that GLP-1 also has~     cardio-protection effects. GLP-1 agonists is able to improve markers of cardiac function,~     reduce myocardial infarct size and post-myocardial infarction remodeling in experimental~     myocardial infarction. And GLP-1 infusion improved left ventricular function and increases~     myocardial salvage in patients with acute myocardial infarction (AMI). The investigators'~     previous study found that GLP-1 analogues attenuated ischemia-reperfusion induced apoptosis~     of stem- and myocardial microvascular endothelial cells, and liraglutide (a GLP-1 analog)~     usage during hospital stay can prevent no-reflow and improve heart function in AMI.~     Therefore, the investigators carried out a cohort study to evaluate the association between~     plasma GLP-1 and in-hospital complications in patients with ST-segment elevation myocardial~     infarction.~   "
19261|NCT03314831|"~     The aim of the study is to measure serum levels of myristic acid in septic patients and to~     compare them with myristic acid serum levels in patients with Systemic Inflammatory Response~     Syndrome of non infective etiology in cohort of patients undergoing cardiac surgery.~     Furthermore, other biomarkers of sepsis are evaluated in comparison with microbiological~     findings detected either by standard cultures or by molecular biological methods.~   "
19262|NCT03314818|"~     This proposed follow-up study aims to recruit participants from the original BioImage cohort~     for a one-time follow-up examination. The repeat ultrasound scan of the carotid arteries will~     provide information on the natural history of carotid atherosclerosis and factors that~     contribute to plaque progression. Renewal of the HIPAA authorization will also be sought for~     5 years to continue to monitor claims and other information for major cardiovascular events,~     other outcomes and healthcare utilization.~   "
19263|NCT03314805|"~     Adjuvant chemotherapy usually is recommended after surgery for breast cancer patients who are~     at significant risk for disseminated disease. Chemotherapy has been demonstrated to reduce~     the risk of breast cancer recurrence. Anthracycline-based regimens, including doxorubin or~     epilubicin, are the breast cancer adjuvant chemotherapy standards of care. Fatigue has also~     been identified as the most problem for breast cancer patients under adjuvant chemotherapy.~     In the current study, it is aimed to show that PG2 (astragalus polysaccharides) treatment~     among stage II/III breast patients under adjuvant EC regimen in reduction of~     chemotherapy-induced toxicity and encouraging compliance with chemotherapy.~   "
19264|NCT03314792|"~     Opioids remain the first-line drugs for the treatment of moderate to severe postoperative~     pain, but the use is limited by well-known side-effects, most of which are dose-dependent.~      The opioid oxycodone is standard therapeutic treatment for acute postoperative pain, either~     in immediate-release formulation, OxyNorm®, or as extended-release formulation, OxyContin®.~     Oxycodone provides analgesic effects through µ-opioid receptors in the central nervous~     system.~      Tapentadol hydrochloride/depot (Palexia/depot®) is a novel, centrally acting, strong~     analgesic with a dual mechanism of action on µ-opioid receptors and noradrenaline reuptake in~     the central nervous system. Tapentadol is an active compound, devoid of active metabolites~     and not reliant on enzyme systems. For these reasons, it has a low drug interaction~     potential. This dual mechanism also translates clinically into less adverse effects than with~     pure opioid agonists like oxycodone. This is probably due to less µ-opioid receptor~     stimulation.~      Tapentadol has been shown effective in models of acute, osteoarthritic, neuropathic and~     cancer pain. There is now an increasing use of tapentadol in postoperative pain treatment in~     Norway. However, there is a lack of broad-based evidence for the use of tapentadol in the~     post-surgical setting. So far, to our knowledge, there are only published studies on~     postoperative pain treatment after orthopedic and dental surgery, but none related to deep~     abdominal pain.~      Tapentadol is shown in several studies on chronic pain patients to have comparable analgesic~     effects to traditional opioid pain medications like oxycodone and morphine, but with a more~     tolerable side-effect profile. In the postoperative setting after dental or orthopedic~     surgery, studies have shown less nausea and constipation. It has also been suggested a lower~     frequency of pruritus compared with oxycodone, but no difference in central nervous system~     symptoms such as sleepiness or dizziness. The most dangerous side-effect from opioids is~     respiratory depression with the potential of fatal outcome. The investigators have not found~     any publications from short-term postoperative pain management comparing the respiratory~     effect of tapentadol to the traditional opioids.~      The aim of the study is to compare the analgesic effect and side-effects of this new~     analgesic, tapentadol, to the standard treatment to day, oxycodone, in the acute~     postoperative period after hysterectomy.~   "
19265|NCT03314779|"~     The first aim of this study is to investigate the frequency and severity of a specific~     pathological metabolic pattern, mitochondrial dysfunction, of the brain in comatose patients~     under neurocritical care. This pattern is recognized as a complication after compromised~     blood flow to the brain and may be amenable to treatment. The other main aim of this study is~     to correlate patterns of metabolites between brain and jugular venous blood. It is probable~     but not proven that jugular venous microdialysis can mirror the global metabolic state of the~     brain.~   "
19266|NCT03314766|"~     The purpose of this study is to evaluate the long-term clinical acceptability and overall~     satisfaction with the IC-8 IOL at least 12 months post-IOL implantation.~   "
19267|NCT03314753|"~     Retrospective data collection on re-ablations performed within the FIRE AND ICE Trial.~   "
19268|NCT03314740|"~     This is a Phase II, randomized, multi-centre study aiming at comparing the efficacy of~     Olaparib and Cediranib vs. weekly Paclitaxel in terms of progression free survival (PFS) in~     platinum refractory or resistant recurrent ovarian cancer.~      Patients will be randomised in a 1:1:1 ratio to three treatment arms:~        -  Arm A: Paclitaxel 80 mg/mq every week~        -  Arm B: Cediranib 20 mg/day + Olaparib 600 mg / day (i.e. 300 mg BD) given every day~        -  Arm C: Cediranib 20 mg/day given 5 days per weeks + Olaparib 600 mg / day (i.e. 300 mg~          BD) given 7 days per weeks~   "
19284|NCT03314532|"~     Hepatocellular carcinoma (HCC) is one of the most common cancers in the world with major~     occurrences in eastern Asian countries such as China. HCC is the third leading cause of~     cancer-related deaths in the world. There are multiple treatment options for liver cancer~     including surgery, transcatheter arterial chemoembolization (TACE), liver transplantation,~     absolute ethanol injection, radiation therapy, and biological therapy. Surgery is the primary~     radical treatment measure for HCC, but its indication is narrow and is only suitable for~     certain group of patients. Another common treatment for liver cancer, TACE, can not only~     block tumor blood supply, control tumor growth, or even cause necrosis and result in tumor~     shrinkage, it can also deliver target chemotherapy drugs to the tumor tissue. However, there~     are still some controversies on the efficacy of TACE treatment. Therefore in this study, we~     will conduct a randomized comparison study of the efficacy of surgical resection and~     TILA-TACE treatment.~   "
19285|NCT03314519|"~     The study contain result from comparison of diagnostic result about lung collapsibility by~     using lung ultrasonography as intervention compare to fiberoptic bronchoscopy as gold~     standard~   "
19269|NCT03314727|"~     Diets containing excessive salt (>12 g/day) have negative effects on kidney and~     cardiovascular system. Considering this known fact, the investigators aimed to study if the~     amount of the water taken with excessive salt had any part on these negative effects by~     testing the blood pressure, serum osmolality, endothelial functions, cardiac function,~     inflammatory parameters and sympathetic nervous system.~      Excessive dietary salt raises the serum osmolality, which triggers the protection mechanisms~     of the body. The first mechanism is the secretion of vasopressin from posterior pituitary and~     the second one is the polyol mediated aldose reductase enzyme activation in renal tubules. In~     the beginning, water and a little amount of salt is reabsorbed from the kidneys for keeping~     the serum osmolality in normal ranges by the elevation of vasopressin. Besides the high~     levels of vasopressin for long durations may have a role in both developments of hypertension~     and the progression/development of chronic kidney disease. Polyol mediated aldose reductase~     enzyme turns glucose into sorbitol, which is turned to fructose by sorbitol dehydrogenase~     activity. Fructose is degraded by fructokinase activity into toxic substances. With this~     pathway, the acute energy need is satisfied, yet uric acid, local oxidative stress, and~     inflammatory mediators rise while nitric oxide levels decreasing. These facts are independent~     risk factors for both kidney disease progression and hypertension. In addition, excessive~     salt intake may elevate the transforming growth factor beta-1 (TGF-B1) levels, which~     activates the sympathetic system, inflammation, and endothelial dysfunction.~      According to these data, the investigators speculate that if they increase the amount of~     water intake while eating the high salt diet they may decrease the toxic effect of salt with~     less increase in serum osmolarity. To test this hypothesis, by regulating the salt and water~     amount in healthy people's diets, the investigators aimed to evaluate the following these~     parameters; biochemical parameters that could affect the blood and urine osmolality, blood~     pressure, vascular endothelial functions with the non-invasive flow-mediated dilatation~     technique and arterial stiffness, systolic and diastolic functions of the heart by~     transthoracic echocardiography. In addition, it was planned to evaluate the hormonal effects~     of arginine vasopressin, a long peptide with 39 amino acids, which is longer and easier to~     measure than vasopressin levels in serum by measuring the pituitary hormone-derived copeptin.~      Although, decreasing the salt intake is the first step of the treatment in hypertension, and~     kidney diseases, the compliance rate to less sodium intake is very low (<20%). The~     investigators aim is to evaluate the effects of water, which is taken acutely with the~     excessive salt intake on cardiovascular system and kidney. The findings of the study will~     important for public health. If the investigators prove their hypothesis, they may recommend~     increasing high water intake before feeling thirst of which may contribute to decreasing the~     prevalence of hypertension and kidney disease.~   "
19270|NCT03314714|"~     Accumulation of intramyocellular lipids (IMCLs) due to increased supply of fatty acids can~     induce defects in the insulin signaling cascade, causing skeletal muscle insulin resistance.~     However, the causes for muscle insulin resistance are not well understood. The association of~     elevated IMCLs and insulin resistance has been shown in obese humans and individuals with~     type 2 diabetes as well as several animal models of insulin resistance. Despite the strong~     relationship between IMCLs and insulin resistance, this suggested relationship disappears~     when well-trained endurance athletes are included into this consideration as this group is~     highly insulin sensitive. This metabolic enigma has been termed the 'athlete's paradox'. The~     aim of this project is to resolve the mechanisms contributing to the athlete's paradox.~   "
19271|NCT03314701|"~     Chest trauma is the most common injury in the emergency trauma and rib fractures is the most~     common trauma in chest trauma. Severe rib fractures can cause paradoxical respiration and~     mediastinal swing, which has large effects on respiratory and circulatory system, result in~     acute respiratory distress syndrome. Mechanical ventilation can significantly improve the~     hypoxemia of the patients, correct paradoxical respiration, and treat the pulmonary~     atelectasis~   "
19272|NCT03314688|"~     The proposed study is a randomized trial evaluating the impact of a dietary and physical~     activity guidelines intervention vs. usual care on adherence to breast cancer treatments,~     body composition, and changes in biomarkers in 250 women newly diagnosed with breast cancer~     scheduled to receive neoadjuvant or adjuvant chemotherapy.~   "
19273|NCT03314675|"~     The study is designed to collect data on LV latency in CRT-D patients by the CRT-D and~     compare measurements to 12-lead ECG data~   "
19274|NCT03314662|"~     This phase 3 study is a randomized, double-blinded, comparator controlled, parallel-group,~     multicenter study of aQIV versus the US-licensed 2017-2018 adjuvanted trivalent influenza~     vaccine (aTIV-1, Fluad), and versus an adjuvanted trivalent influenza vaccine (aTIV-2),~     containing the alternate B strain.~   "
19275|NCT03314649|"~     Our study aims to improve sensitivity and accuracy of detecting abdominal free cancer cells~     in patients with gastric cancer.~   "
19276|NCT03314636|"~     A PET-CT will be performed on patients with myeloma after a standard first-line treatment.~     The PET-positive patients will receive 4 cycles of Carfilzomb-Revlimid-Dexamethason (KRd),~     before a new PET-CT will be performed.~   "
19277|NCT03314623|"~     The purpose of this study is to investigate if immediate mobilization with weight bearing as~     tolerated following surgery with plates and screws after a fracture of the shinbone near the~     knee is possible without increased risk.~      The investigators hypothesize immediate weight bearing as tolerated following surgery with~     plates and screws of the above mentioned fracture, in cases deemed stable by the surgeon,~     will not lead to any loss of reduction.~   "
19278|NCT03314610|"~     This study evaluates the effect of the need to void on parkinsonian gait~   "
19279|NCT03314597|"~     We hypothesized that rehabilitation specifically addressing balance in Parkinson ́s disease~     patients might improve not only balance, but locomotion as well. Two balance training~     protocols (standing on a moving platform, and traditional balance exercises) were compared by~     assigning patients to two groups: moving platform (n=15) and balance exercises (n=17).~     Platform moved periodically in antero-posterior, latero-lateral and oblique direction, with~     and without vision in different trials. Balance exercises were based on Otago Exercise~     Program. Both platform and exercises sessions were administered from easy to difficult.~     Outcome measures were: a) balancing behaviour, assessed both by index of stability (IS) on~     platform and by Mini-BESTest, b) gait, assessed both by baropodometry and by Timed Up and Go~     (TUG) test. Falls Efficacy Scale-International (FES-I) and Parkinson's Disease Questionnaire~     (PDQ-8) were administered. Both groups exhibited better balance control, as assessed both by~     IS and by Mini-BESTest. Gait speed at both baropodometry and TUG also improved in both~     groups. Scores of FES-I and PDQ-8 showed a marginal improvement. A four-week treatment~     featuring no gait training, but focussed on challenging balance tasks produces considerable~     gait enhancement in mildly to moderately affected patients. Walking problems in PD depend on~     postural instability and are successfully relieved by appropriate balance rehabilitation.~   "
19280|NCT03314584|"~     Persistent headache is one of the most common debilitating symptoms in military personnel~     suffering from mild traumatic brain injury (MTBI). This study aims to assess the long-term~     effect of repetitive transcranial magnetic stimulation (rTMS) in managing MTBI related~     headaches for up to 2-3 months by comparing the treatment effect of active-rTMS to sham-rTMS.~   "
19286|NCT03314506|"~     The purpose of this study is to measure the effects of a single session of exercise on~     changes in the cellular composition of the body fat of humans.~   "
19289|NCT03314467|"~     Diabetic retinopathy (DR) is the most common visual complication of diabetes. Risk factors~     for developing DR are diabetes duration, glycemic control, and hypertension . The prevalence~     ranges from 17 to 61% according to the diabetes duration .~      Obstructive sleep apnea syndrome (OSAS) is very frequent in Type 2 Diabetes population,~     reaching a prevalence of 23-48% .~      Few is known about the exact role of OSAS in the development of DR. A recent study has shown~     that OSAS is an independent predictor for the progression to pre-/proliferative DR. The~     purpose of the present study is to assess if the presence of OSA in diabetic patients is a~     predictive factor for DR occurrence.~   "
19290|NCT03314454|"~     The overall goal is to pilot test and establish a procedure for video-assisted alcohol~     topography and explore its utility as an indicator of alcohol use disorder. There are 4~     phases to this study: 1) pre-screening by phone; 2) in-person screening appointment; 3) the~     first alcohol drinking session with videotaping; and 4) follow-up appointment for retest.~   "
19291|NCT03314441|"~     The purpose of the study is to assess the effects of regular Viniyoga in patients suffering~     from primary insomnia.~   "
19292|NCT03314428|"~     Tibiofemoral osteoarthritis (TFOA) is highly prevalent in older adults, and often causes~     symptoms and functional limitations. Physical activity is widely advocated in people with~     TFOA, and running is an easy and accessible activity that provides many benefits on general~     health. However, running induces high knee loads, which could potentially contribute to~     symptoms of runners with TFOA. Previous studies have suggested that running gait~     modifications can help in decreasing symptoms and knee loading in runners with knee~     conditions. Yet, no study has been conducted in runners with TFOA. This intervention study~     will investigate the effects of a 4-week running gait retraining program on symptoms and~     running biomechanics in runners with TFOA. We hypothesize that running modifications will~     decrease symptoms, improve function and reduce knee loading.~   "
19293|NCT03314415|"~     The purpose of this study is to determine whether robotic assistance can help facilitate~     adherence, engagement, and weight loss in participants enrolled in a behavioral weight loss~     program. All participants will be enrolled in the same Web-based weight loss program and take~     part in robotic assistance sessions either early or late in the five-week study. These~     robotic assistance sessions involve speaking one on one with a robot about diet-related~     progress.~   "
19294|NCT03314402|"~     A randomized, double-blinding, dose-escalated phase 1 trial to evaluate the tolerance and~     fasting/postprandial pharmacokinetics of jaktinib.~   "
19295|NCT03314389|"~     The purpose of this current study is to examine the sensation of the corneal and conjunctiva~     sensation before and after pterygium surgeries by Cochet bonnet esthesiometer and to examine~     epidemiological, clinical and imaging factors the influence the sensation~   "
19296|NCT03314376|"~     The aim of this study is to prove the effects of a individualized prehabilitation program~     (muscular strength and endurance) in patients in a waiting list for a transplant. The~     investigators want to see if patients that did a prehabilitation program have better results~     in the postoperative period.~   "
19297|NCT03314363|"~     The aim of the present study is to assess the metabolic impact of Continuous Renal~     Replacement Therapy and overview the obstacles and important factors compromising the use of~     Indirect Calorimetry in CRRT and suggest a model to overcome these issues.~   "
19298|NCT03314350|"~     In geriatric patients, there is a plethora of nutritional and illness-related parameters,~     resulting in a complex situation which hampers identification of risk factors.In the planned~     prospective study, the point and period prevalence of wound healing disorders (WHD) is~     examined at admission and at discharge in a cohort of 517 male and female geriatric patients.~     As the investigators are also interested to study the occurrence of WHD in patients with~     malnutrition (and other geriatric phenomena) compared to the prevalence of WHD in patients~     with a good nutritional Status.~   "
19299|NCT03314337|"~     The purpose of this study is to compare outcomes of patients undergoing distal pancreatectomy~     with or without pancreatic stent~   "
19300|NCT03314324|"~     To assess patient preference between ODM-201 and enzalutamide by patient preference~     questionnaire~   "
19301|NCT03314311|"~     The ReStOre trial is a multi-disciplinary intervention of exercise, diet and education for~     patients who have completed treatment for oesophageal cancer. The intervention aims to~     improve quality of life and functional performance following oesophageal cancer and assist~     patients to return to normal activity during the early survivorship phase. The 12-week~     intervention will involve structured exercise training, individual dietary advice and~     multi-disciplinary education sessions addressing a range of survivorship needs.~   "
19302|NCT03314298|"~     A single dose trial to evaluate the pharmacokinetics of testosterone and anastrozole from~     subcutaneous testosterone and anastrozole (T+Ai) in premenopausal women~   "
19303|NCT03314285|"~     This study aimed to investigate the effect of chronic neck pain on sleep quality and to~     determine the factors that may be related to sleep disturbance.~   "
19304|NCT03314272|"~     The purpose of this randomized controlled trial is to evaluate a fully automated algorithm~     for the establishment of glycemic control in diabetic patients and to compare the results~     with routine management of hyperglycemia in patients undergoing cardiopulmonary bypass~     surgery.~   "
19305|NCT03314259|"~     Post operative urinary retention ( POUR) is caused by sympathetic activation of the internal~     urethral sphincter after surgery. The smooth muscles of the around the internal urethral~     sphincter have been demonstrated to be rich in alpha-1 adrenergic receptors. Our research~     idea is novel because there has been no prior prospective study conducted using~     alpha-blockers to reduce post-operative urinary retention in patients undergoing inguinal~     hernia repair. The proposed research is important as existing studies that sought to~     understand POUR have merely established the risks factors involved. Despite so, the incidence~     of POUR remains high and no studies to date have investigated the use of specific~     interventions to reduce the risk of POUR.~      This is essential as patients who develop POUR have also been successfully shown to have~     significantly longer length of hospitalisation. Besides, the development of POUR can also~     cause significant pain/discomfort, increase risks of long-term urethral catheterisation and~     predispose patients to urinary tract infections~   "
26262|NCT03223220|"~     The investigators plan to undertake a phase II study to investigate the efficacy and side~     effects of intravenous ketamine to reduce neuroexcitotoxicity, and thus provide~     neuroprotection in patients diagnosed with acute ischemic stroke.~   "
19306|NCT03314246|"~     Background: Ramadan fasting is a religious observance carried out by Muslims all over the~     world. During Ramadan, Muslims abstain from eating, drinking, and smoking during daylight~     hours. Although Muslims who are ill, including patients with diabetes, are exempted from~     fasting, many devoted Muslim patients still insist on fasting despite being advised not to by~     their healthcare providers. Concerns have been raised over how the practice of fasting may~     affect the metabolic control of Muslim patients with diabetes. Furthermore, it has also been~     postulated that the act of fasting may increase the risk of hypoglycemia or glucose toxicity.~     Although practice algorithms and suggestions on the use of glycemic therapies during fasting~     have been discussed internationally. they are not generalizable as the observances of~     Ramadan, duration of fasting and the food ingested differ from one country to another.~      Aims: This study aims to develop and implement a clinical practice dose-adjustment algorithm~     dedicated to the care of Singaporean patients with diabetes who fast during Ramadan.~      Hypothesis: The use of clinical practice dose-adjustment algorithm can improve both clinical~     and humanistic outcomes of patients with type 2 diabetes who wish to fast during Ramadan.~      Methods: This is a prospective, randomized, interventional study involving patients with type~     2 diabetes who wish to fast for at least 10 days during Ramadan. Eligible patient attending a~     primary care institution or an outpatient specialist clinic of a tertiary institution will be~     approached to participate in the study. Consented patients will be randomized to either~     intervention arm or control arm. Patients in the control arm will receive usual care while~     patients in the intervention arm will be given additional education session on Ramadan~     fasting related diabetic management advice and an algorithm that was developed by the study~     team members based on international guidelines, to guide them on self-management during~     Ramadan. The primary outcomes will be change in HbA1c. Secondary outcomes include change in~     fasting blood glucose, post prandial blood glucose, medication adherence and humanistic~     outcomes. The safety outcomes include self reported incidence of major and minor hypoglycemia~     as well as hyperglycemia during Ramadan month. All outcomes will be measured at baseline,~     during Ramadan and at 3 month post Ramadan.~      Significance: The validation of the algorithm through this study will ensure effective and~     safe fasting of patients with type 2 diabetes during Ramadan.~   "
19307|NCT03314233|"~     Congenital diaphragmatic hernia (CDH) is a congenital anomaly associated with a high risk of~     mortality and need for life-saving interventions such as extracorporeal membrane oxygenation~     (ECMO), nitric oxide, and vasopressor support. Although infants with CDH experience~     significant morbidity and mortality starting immediately after birth, high quality evidence~     informing delivery room resuscitation in this population is lacking.~      Infants with CDH are at risk for pulmonary hypoplasia and pulmonary hypertension and often~     experience hypoxemia and acidosis during neonatal transition. The standard approach to DR~     resuscitation is immediate umbilical cord clamping (UCC) followed by intubation and~     mechanical ventilation. Animal models suggest that achieving lung aeration prior to UCC~     results in improved pulmonary blood flow and cardiac function compared with immediate UCC~     before lung aeration is established. Trials of preterm infants demonstrated that initiating~     respiratory support prior to UCC is safe and feasible. Because infants with CDH are at high~     risk for pulmonary hypertension and systemic hypotension, they may benefit from the~     hemodynamic effects of lung aeration before UCC, namely increased pulmonary blood flow,~     decreased pulmonary vascular resistance, and improved cardiac output. To date, this approach~     has not been studied in infants with CDH.~   "
19308|NCT03314220|"~     This study aimed to accomplish the following objectives:~        1. Develop a family-centered preoperative preparation program.~        2. Evaluate the effectiveness of this program in terms of children's preoperative emotional~          behaviors, postoperative behavior, and posthospital behavior and caregivers' anxiety.~   "
19309|NCT03314207|"~     The purpose of this study is to evaluate subjects with X-linked retinitis pigmentosa caused~     by RPGR-ORF15 mutations in a clinical setting to fully characterize their condition, measure~     testing variability, and estimate rates of progression of clinical parameters.~   "
19310|NCT03314194|"~     Samples will be collected to determine human genetic variation, fecal and oral microbial~     communities, and metabolome products. Several evolutionary and ecological diversity metrics~     will be distilled to test: a) if microbiome variation within each ethnicity is less than that~     between ethnicities; b) if microbiome variation is finely structured according to genetic~     relatedness; and c) if dietary variation impacts human genome x microbiome associations.~   "
19311|NCT03314181|"~     This is a study of venetoclax, daratumumab, and dexamethasone with and without bortezomib~     combination therapy to evaluate safety, tolerability, and efficacy of these combinations in~     participants with relapsed or refractory multiple myeloma. The study will consist of 2~     distinct parts: Part 1 includes participants with t(11;14) positive relapsed/refractory (R/R)~     multiple myeloma who will receive venetoclax in combination with daratumumab and~     dexamethasone (VenDd); Part 2 includes participants with R/R multiple myeloma who will~     receive venetoclax in combination with daratumumab, bortezomib, and dexamethasone (VenDVd).~      Each Part will be initiated with a dose-escalation phase. During the open-label, escalation~     phases, increasing doses of venetoclax with fixed doses of daratumumab and dexamethasone~     (Part 1a) or daratumumab, bortezomib, and dexamethasone (Part 2a) will be administered. The~     dose-escalation phases will be followed by either a randomized, and blinded (Part 1b)~     expansion phase or single-arm and open-label (Part 2b) expansion phase.~   "
19312|NCT03314168|"~     This study aims to investigate the effects of different volumes of combined training on~     fatigue, neuromuscular variables, morphological, cardiorespiratory capacity, and quality of~     life, in breast cancer (BCa) women undergoing primary treatment. Two thirds will be the~     intervention group that will perform combined training, while the other third will be the~     control group that will have physiotherapy sessions.~   "
19313|NCT03314155|"~     the investigators make the following assumptions: 1) neuroinflammation in MDD can be measured~     by the [18 F ] DPA- 714 ; 2) it is accompanied by anatomical and functional changes in the~     frontal subcortical loops, strongly involved in MDD ; 3) neuroinflammation in patients might~     be a biomarker related to resistance to treatment in patients with MDD. If this assumptions~     are validated, then this study will enable a better understanding of the neuroinflammatory~     processes. This breakthrough could have a long term therapeutic impact, helping to target~     more specifically antidepressant drugs with anti-inflammatory action and / or drugs targeting~     neuroinflammation.~   "
19314|NCT03314142|"~     This study investigated the effects of bran's particle size on glycemic responses~   "
19315|NCT03314129|"~     The purpose of this study is to evaluate the effectiveness of a visual remediation~     intervention for people with schizophrenia. The intervention targets two visual functions~     that much research has shown are impaired in many people with the disorder, namely contrast~     sensitivity and perceptual organization. The first phase of the study will test the effects~     of interventions targeting each of these processes, as well as the effects of a combined~     package. A control condition of higher-level cognitive remediation is included as a fourth~     condition. The second phase of the study will evaluate the effectiveness of the most~     effective intervention from the first phase, but in a new and larger sample of individuals.~     Outcome measures include multiple aspects of visual functioning, as well as visual cognition~     and overall community functioning.~   "
19317|NCT03314103|"~     Varicella-zoster virus (VZV) is a herpesvirus that causes two distinct clinical~     syndromes.Primary infection is manifested as varicella (chickenpox), whereas reactivation of~     latent VZV results in a localized eruption known as herpes zoster. More than 99.6% of people~     40 years of age orolder had evidence of previous VZV infection. This study plans to have~     30000 adults 40 years of age or older involoved in a randomized, double-blind,~     placebo-controlled trial of an investigational live attenuated varicella-zoster virus~     vaccine. The investigational vaccines are produced by Changchun Changsheng biotechnology co.~     LTD. The incidence of herpes zoster and the severity, and duration of the associated pain and~     discomfort were measured after the vaccination. And the safety of the varicella-zoster virus~     vaccine is also evaluated.~   "
19318|NCT03314090|"~     Cleft lip / palate is the most common craniofacial anomaly in humans. Lip repair is one of~     the most important reconstructions for these patients, and is performed at around 3 months of~     age. Although the cheiloplasty scar is unavoidable and permanent, every possible measure~     should be considered to optimize its functional and aesthetic outcome, since the scar can be~     a lifelong social stigma of a cleft lip operation. Hypertrophic scarring can highlight the~     scar even further, and is a recognized negative outcome for cheiloplasty. Moreover, with an~     incidence as high as 36.3% , hypertrophic scars are more common in Asian-Orientals compared~     to Caucasians.~      The population treated at investigator's institution is almost entirely Oriental (Taiwanese).~     Patients' intrinsic higher risk of hypertrophic scarring has led investigators continuously~     to try to improve scar quality for them. In 2011, investigator started a double-blinded,~     randomized, vehicle-controlled, prospective clinical trial to evaluate whether the injection~     of botulinum toxin A into the orbicularis oris muscle could improve the quality of the cleft~     lip scar . The results revealed that botulinum toxin injections into the subjacent~     orbicularis oris muscle produced narrower cheiloplasty scars, but provided no additional~     benefits in terms of scar pigmentation, vascularity, pliability or height. During that study,~     the parents of 14% (4/29) of the babies within the control group reported that participant~     baby had tried, albeit unsuccessfully, to ingest the silicone sheet at night. This caused~     investigator to question the safety of silicone sheeting on the upper lip in babies.~      Silicone is known to be effective for treating and/or preventing hypertrophic scarring .~     Silicone gel has been shown to prevent hypertrophic scars in median sternotomy wounds 8.~     Investigators therefore conducted this clinical trial to evaluate whether post-operative use~     of silicone gel was non-inferior to silicone sheet for preventing hypertrophy of unilateral~     cleft lip repair scars.~   "
19319|NCT03314077|"~     There is lack of quality control and evaluation indexes for standard COPD management in~     hospitals at different levels in China, leading to nonstandard in COPD management and~     discrepancy in therapeutic efficiency. This study focuses on establishing quality control and~     evaluation indexes for standard COPD management in hospitals at different levels in China,~     and evaluating the therapeutic efficiency after standard COPD management. This study is an~     observational study which lasts 2 years. After standard COPD management according to GOLD by~     doctors in hospitals at different levels in China, patients will be identified their~     compliance on doctors' advice and prescription, and followed up their outcome after 1 year.~     Several indexes will be selected to evaluate the quality control of standard COPD management~     and its efficiency.~   "
19320|NCT03314064|"~     DTG 50 milligram (mg) tablet was approved for marketing in Russian Federation; however, DTG~     is not currently available for subjects at Acquired Immune Deficiency Syndrome (AIDS) Centers~     as it is not available for order and supply via Federal program. This study is an open-label~     study which will include subjects, who complete taking DTG in studies ING112276, ING113086,~     ING114915, ING111762, and those subjects who end participation in study 200304 in which they~     received either DTG or lopinavir/ritonavir (LPV/RTV). DTG will be supplied at a dose of 50 mg~     once daily to eligible subjects until the subject stops taking DTG or transitions to~     commercial supply of DTG when available at AIDS Centers via the Federal program. The~     objective of this study is to bridge the gap between the closure of ING112276, ING113086,~     ING114915, ING111762 or end of subject's participation in 200304 and the actual availability~     of commercial DTG at AIDS Centers via Federal program for human immunodeficiency~     (HIV)-1-infected adult subjects in Russian Federation. The study will also investigate~     long-term safety of DTG for subjects continuing DTG in Russian Federation.~   "
19321|NCT03314051|"~     No previous study reported the treatment outcome of stage III nasopharyngeal carcinoma (NPC)~     patients. The investigators try to investigate the long-term treatment outcome of stage III~     NPC patients and do risk grouping by plasma Epstein-Barr virus (EBV) DNA assay for future~     therapy improvement.~   "
19322|NCT03314038|"~     Chronic atrophic gastritis (CAG) is acknowledged as the precancerous stage of gastric cancer~     (GC). The present study aims to explore Traditional Chinese Medicine (TCM) syndrome features~     in different stages of CAG malignant transformation respectively. The proposed study is a~     cross-sectional study based participant survey conducted in 4 hospitals in Beijing, China.~     After obtaining informed consent, a total of 2000 study patients will be recruited on-site in~     hospitals.~   "
19323|NCT03314025|"~     Post-operative urinary retention (POUR) is a frequent complication reported as ranging from~     10 to 55% in the literature. In a recent retrospective study from Laliberte et al in Quebec~     City, we observed that 19% of the patients operated using transanal endoscopic microsurgery~     (TEM) had a post-operative urinary retention (POUR). Factors related to the patient, the~     tumor and the surgery were not observed to be associated risk factors. Tamsulosin has been~     shown as an effective preventive agent of POUR for certain ano-rectal and inguinal surgeries.~     The efficacy of this prophylactic therapy in transanal endoscopic microsurgery has not been~     studied yet and is unclear considering the particularities of this procedure. TEM uses a~     rigid proctoscope of four centimeters of diameter and creates a continuous pneumorectum~     (insufflation of the rectum during all the procedure). We think that these two elements,~     which cause local inflammation, may be part of the reason explaining the high incidence of~     post-operative urinary retention after TEM procedures. The objective of our multicenter~     clinical trial is to evaluate the effect of perioperative tamsulosin for the reduction of~     POUR in men, as well as the impact on the interventions and hospital admissions related to~     this complication.~   "
19324|NCT03314012|"~     The carotid body is located at the bifurcation of the internal and external carotid arteries.~     It is a chemoreceptor that plays a role in the sympathetic nervous system and in the~     development and maintenance of hypertension. Hypertension is a major cardiovascular risk~     factor and is associated with coronary artery disease, stroke, chronic kidney disease, and~     heart failure.~      The objective of this study is to assess the effectiveness and safety of a catheter-based~     system to ablate the carotid body and reduce blood pressure (BP) in patients with resistant~     hypertension and to confirm sustainability of the treatment benefits long-term as seen~     following surgical CB removal.~   "
19325|NCT03313999|"~     This protocol will utilize the lymphedema indentometer, or durometer (a novel, noninvasive~     piece of equipment that measures skin elasticity), to better characterize disease progression~     in patients with lymphedema. Beth Israel Deaconess Medical Center patients who undergo~     treatment of lymphedema will be candidates for this noninvasive test. This device and the~     data it generates will help understand the incidence of lymphedema at Beth Israel Deaconess~     Medical Center compared to national data and the outcomes of surgical treatment of~     lymphedema.~   "
19326|NCT03313986|"~     Penile curvature in adults is divided into two main categories the first is congenital penile~     curvature with orthotopic meatus and the other is acquired curvature which its common causes~     are Peyronie's disease (PD) and previous penile surgery as for hypospadias repair.The~     congenital penile curvatures (CPC) which not associated with urethral malformation is a~     relatively uncommon condition that may present in late adolescent or early adult life. The~     incidence is estimated to be 0.6 % but the incidence of clinically significant CPC is much~     lower, as the degree of curvature and sexual dysfunction varies widely Penile curvature may~     lead to inability for sexual intercourse. These cases require treatment. Acquired penile~     curvature its most common cause is Peyronie's disease. Peyronie's disease is a fibrotic~     disorder of the tunica albuginea of the corpora cavernosa that is clinically defined by the~     presence of a palpable, inelastic tunical plaque. PD is relatively common and affects up to~     20.3% of adult men to some degree.~      Surgery is gold-standard for treatment of curvature in stable PD. Surgical therapy is~     subdivided into three main procedures: (1) plication techniques (Penile shortening~     procedures), (2) grafting procedures with partial plaque excision or incision followed by~     defect closure with various grafts, and (3) correction of deviation with simultaneous penile~     prosthesis implantation in patients with ED not responding to medical therapy.~      In this study results of different surgical techniques in management of penile curvature will~     be compared.~   "
19327|NCT03313973|"~     Lower respiratory tract infections are one of the main hospitalization or mortality cause in~     idiopathic Parkinson's disease. Because of akinesia and articular rigidity these patient~     develop restrictive syndrome by reduction in the thoraco-lung compliance.The consequence is a~     progressive loss of the aerobic physical abilities and infection.~      The myotensive technique of active muscular stretching seem to increase the range of motion~     in healthy subject but also in patient with chronic bronchiotisis . These technics also~     increase the vital respiratory capacity and re enforce the muscles.So adding these technics~     during the period when the Parkinson's disease patient is stable would be a way of~     improvement .~   "
19328|NCT03313960|"~     The A-One study is a prospective, randomized controlled trial evaluating the use of the One~     Drop | Premium 'On Track' in combination with Afrezza treatment on the glycemic control,~     treatment adherence, social-cognitive barriers to adherence, and treatment satisfaction of~     people with Type 2 diabetes (T2D) and a hemoglobin A1c (A1c) > 7.0% already prescribed an~     injectable rapid-acting insulin.~   "
19329|NCT03313947|"~     This is a novel approach to assess the use of ultrasound to support the identification of~     obstructive sleep apnea syndrome (OSAS) on a screening questionnaire, and potentially to~     predict a difficult pediatric airway. The investigators hope to determine if a combination of~     simple bedside clinical tests can be used to identify OSAS in patients who present for~     surgery with clinical signs of OSAS but without a formal polysomnography.~   "
19330|NCT03313934|"~     The purpose of this study is to investigate the efficacy and longevity of Platelet Rich~     Fibrin (PRF) in combination with hyaluronic acid filler for cosmetic volume restoration of~     the tear troughs. This study will also evaluate visible improvement in skin texture that may~     be attributable to the added PRF.~   "
19331|NCT03313921|"~     The assessment of the refractive state of the eye is a fundamental and important part of~     ophthalmic and optometric clinical practice. The development of an unsupervised online~     subjective refraction method makes a refraction more accessible and can be quite cost-saving.~      In this study, the investigators want to validate an online refraction method which was~     recently created in the Netherlands. The study comprises two different set of participants:~     Part one contains fifty healthy volunteers, 18-40 years of age, with a refractive error and~     no other ophthalmic pathology. Part two contains fifty patients with an ophthalmic pathology.~      The online refraction outcomes will be compared to a manifest refraction and automated~     refraction in a cross-sectional study design.~   "
19332|NCT03313908|"~     Breast cancer is the most common cancer in women. It is the main cause of cancer deaths among~     women. The incidence of non-palpable tumors is estimated at 60%. Their better prognosis and~     their small size encourage the investigators for finding methods simpler and more efficient~     to treat them by breast-conserving surgery with acceptable cosmetic results.~      The pre-operative detection of the tumor lesion is currently carried out by two methods: the~     radioactive seed localization and guidewire technique. Each has its disadvantages: the~     guidewire is uncomfortable for the patients (pain, hematomes..), whereas the radiocolloid~     requires a specialized and complex organization around this radioactive product.~      Recently, a novel method of using indocyanine green (ICG) fluorescence has been described in~     breast cancer and seems promising.~      In this study, investigators evaluate the feasibility and performance of indocyanine green~     fluorescence in non-palpable tumor detection in comparison with radioactive seed localization~     (ROLL)~      Secondary objectives are evaluate the feasibility of the location by the radiologist,~     feasibility of detection by the surgeon, study of the product and the probe.~   "
19333|NCT03313895|"~     This multi-site clinical trial occurs at the University of Minnesota and University of~     Rochester. It tests the efficacy and additive/synergistic effects of an ACT intervention on~     cognition and relevant mechanisms (aerobic fitness, Alzheimer's disease [AD] signature~     cortical thickness, and default mode network [DMN]) in older adults with amnestic MCI (aMCI).~   "
19343|NCT03313765|"~     Gay, bisexual and other men who have sex with men (MSM) are the group at highest risk of HIV~     infection in the United States. Pre-exposure prophylaxis (PrEP) has demonstrated high~     efficacy in preventing HIV infection among MSM. However, uptake in clinical settings has been~     slow for several reasons, including low awareness and education, low perceived HIV risk,~     concern for side-effects, and stigma associated with taking the medication. The purpose of~     the proposed study is to develop and evaluate a brief motivational interviewing (MI)~     intervention to promote PrEP uptake among MSM during the course of routine HIV screening at a~     public sexually transmitted disease (STD) clinic.~   "
19334|NCT03313882|"~     Human heart failure (HF) has been associated with reduced cardiac sodium channel current and~     other electrical remodeling. Recently, the investigators have shown that downregulation of~     cardiac Na+ channels (SCN5A) can contribute to arrhythmic risk and that upregulation can~     mitigate that risk. Furthermore, the investigators have shown that the reduction in cardiac~     SCN5A mRNA abundance is reflected in circulating white blood cells (WBCs), which also express~     SCN5A, and that a reduction in SCN5A is highly predictive of appropriate implanted cardiac~     defibrillator (ICD) therapy. These data suggest that SCN5A regulation contributes to~     arrhythmic risk in HF. Other electrical remodeling events thought to contribute to arrhythmic~     risk include reductions in K+ currents, including Ito, IK1 and IKs are responsible. These~     current reductions have been linked to reduced transcription, translation and expression of~     the corresponding channel subunits, such as Kv4.3, Kir2.1, KvLQT1, and accessory proteins~     including minK and K+ channel interacting protein 2. That all these ion channels are~     downregulated may suggest a common mechanism to reduce ion channel expression. In this~     application, the investigators intend to explore an entirely novel mechanism by which SCN5A~     and other ion channel mRNA abundances are reduced in HF.~   "
19335|NCT03313869|"~     This experiment consists on a 20-day reduction in daily step in free-living active~     individuals to induce physical inactivity. This will be used to test the efficacy of the~     anti-oxidant cocktail we aim to test as a new countermeasure in 2016 during the 60-d bed rest~     planed by ESA/CNES.~      The objective of this study is to investigate whether the cocktail of natural antioxidants~     XXS-2A comprising vitamin E and coupled with omega-3 helps to prevent and / or reduce the~     glucose intolerance and improve oxidative defenses induced by 20 days of physical inactivity~     through daily step reduction~      Although physical inactivity is reported to affect glucose tolerance within days of~     inactivity, we selected a period of 20 days for the effect of the cocktail to take place and~     assess secondary molecular mechanisms. The effect of this short period of inactivity on~     metabolism will moreover be boosted during the last 10 days by taking fructose, a sugar found~     in abundance in fruits, honey and juices, which is known to quickly trigger metabolic~     deregulation.~   "
19336|NCT03313856|"~     To evaluate the effect of oral administration of herbarium mixture Guazuma ulmifolia (GU) and~     Tecoma stans (TS) on metabolic profile in type 2 diabetic patients.~   "
19337|NCT03313843|"~     The purpose of this study is to collect preliminary data on retinal nerve fiber layer and~     ganglion cell layer damage in multiple sclerosis (MS) patients, using optical coherence~     tomography (OCT). For this study the Zeiss Cirrus OCT Imaging System will be used. The same~     system will be used consistently for the duration of the study.~   "
19338|NCT03313830|"~     Muscle protein synthesis can be stimulated by ingestion of protein sources, such as whey,~     casein or soy. Protein supplementation can be useful to restore protein turnover after~     exercise but also to preserve skeletal muscle mass and function in aging adults. Ingestion of~     large doses of essential amino acids (EAA) or certain protein supplements may be an effective~     strategy to induce muscle protein synthesis. However, in many cases, it may not be practical~     or feasible to consume a large volume of amino acids or protein required for an effective~     response by muscle. Several evidences show how reduced strength and muscle mass, even in~     early life, are predictors of early mortality which explicit the importance of developing~     more effective methods to improve muscle quality. Therefore, identifying the better sources~     of protein that have higher anabolic potency is of high significance.~      The goal of this study is to determine the anabolic potency and efficacy of a new and novel~     Whey Protein Hydrolysate mixture (WPH) on skeletal muscle protein synthesis in healthy young~     subjects (age 20-35 yr). Previous studies on rats indicate WPH induces significant increases~     in muscle protein synthesis compared with carbohydrates or whey-amino acid mixture. WPH~     contains mostly peptides, which have physiological effects and could be absorbed more~     rapidly. Preliminary data from preclinical study has also demonstrated that WPH can stimulate~     muscle protein synthesis at lower doses compared with intact whey proteins. Thus, WPH could~     be absorbed more rapidly and may maximally stimulate muscle protein synthesis. Although there~     is substantial data on the individual effects of BCCA and intact protein such as whey, there~     have been no clinical investigations that have explored the efficacy of WPH for stimulating~     muscle protein synthesis in humans.~      Therefore, the investigators propose that WPH will increase muscle protein synthesis.~      They will compare the response of WHP to the response of WHEY when equal protein is provided~     in both treatments.~      10 healthy subjects will be recruited and will receive both WPH and WHEY supplementation in a~     single blind crossover design. Muscle protein synthesis will be measured on both occasions.~     This acute study will allow to determine whether low dose WPH supplementation will be an~     effective nutritional treatment to stimulate muscle protein synthesis in young adults.~     Importantly, this study will provide the necessary preliminary data to design future short~     and long-term clinical trials to improve muscle function and skeletal muscle mass in clinical~     populations.~   "
19339|NCT03313817|"~     Central retinal artery occlusions (CRAO) are the equivalent of an ischemic stroke at the~     retinal level. They share the same risk factors and common pathology. The diagnosis of a CRAO~     is clinically based on the sudden occurrence of a decrease in deep visual acuity with~     fundamentally signs of reactive ischemia.~      Small studies have highlighted the value of cerebral MRI (Magnetic Resonance Imaging) in CRAO~     with almost 25% of ischemic strokes found on diffusion sequences and the demonstration of a~     correlation between anomalies in diffusion sequence and the probability of a pathology with a~     high risk of recurrence (carotid stenosis or emboligenic cardiopathy). But there are usually~     few radiological signs that allow a direct positive diagnosis of CRAO, an etiologic diagnosis~     or a prognosis. This descriptive study will focus on CRAO at the diagnostic and~     post-treatment phases in the short and medium term, in order to (i) identify imaging~     etiologic signs of CRAO with specific sequences from a 3 Tesla MRI, (ii) identify positive~     diagnostic signs of CRAO with the same specific sequences, (iii) correlate these signs with~     the visual prognosis one month after the CRAO.~   "
19340|NCT03313804|"~     This study proposes to treat metastatic non-small cell lung cancer (NSCLC) and head/neck~     squamous cell cancer (HNSCC) patients who are already initiating an immune checkpoint~     inhibitor (such as Nivolumab, Atezolizumab or Pembrolizumab) for disease treatment as per FDA~     approved guidelines. In these patients we will deliver a short-course radiation to a single~     systemic (non-CNS) site within 14 days of receiving the first dose of immune checkpoint~     inhibitors. This sequence allows radiation to release tumor antigens from immune inaccessible~     areas such as necrotic tumor or low perfusion to provide a robust anti-tumor immune response~     with immune checkpoint inhibitors.~      The primary objective is to assess six-month progression free survival (PFS) compared to~     historical control.~   "
19341|NCT03313791|"~     This study was designed to obtain information about the change in postprandial amino acids in~     blood over time, after consumption of different dairy products with varying proportions of~     whey protein and caseins, and different processing conditions.~   "
19342|NCT03313778|"~     The purpose of this study is to assess the safety, tolerability and immunogenicity of~     mRNA-4157 alone in subjects with resected solid tumors, and in combination with pembrolizumab~     in subjects with unresectable solid tumors.~   "
26571|NCT03219164|"~     The primary objective of this study is to evaluate the safety and efficacy of a 14-day course~     versus a 28-day course of aztreonam for inhalation solution (AZLI) in participants with new~     onset Pseudomonas aeruginosa respiratory tract infection.~   "
19344|NCT03313752|"~     A Phase III, single-centre, randomized, 2-arm, parallel-group, double blind,~     placebo-controlled study, consisting of a screening phase (Days -14 to -1), a 4-week~     double-blind, placebo-controlled treatment phase and a 4-week follow-up phase.~      Subjects: Type 2 diabetic patients with coronary artery disease (CAD) not requiring~     revascularization, with sub-optimal glycemic control (HbA1c 7.5-8.5%) on their current~     anti-hyperglycemic regimen~      Subjects will be randomized in a 1:1 ratio to dapagliflozin or placebo.~      Subjects will undergo screening assessment in the 14-day period preceding administration of~     the first dose of study drug on Day 1.~      Primary Objective The primary objective is to assess the effect of dapagliflozin on~     myocardial insulin sensitivity Secondary Objective The secondary objective is to assess~     global heart function, and metabolic systemic effects of dapagliflozin, and glycemic control.~      The study aims to enroll patients with type 2 diabetes with poor glycemic control, and with~     coronary artery disease not requiring revascularization, who have already undergone, under~     routine cardiological assessment, a positron emission tomography (PET) 13NH3 scan in order to~     assess the cardiovascular function. Thus, the study aims to assess whether the improvement in~     cardiac metabolism obtained with dapagliflozin is greater than that obtained with normal~     clinical practice (according to Standards of Care).~   "
19345|NCT03313739|"~     This study was conducted to assess the effects of an educational program that had designed~     based on teach back method in order to improve self-care competency among menopausal women.~   "
19346|NCT03313726|"~     Phase A: To describe and to determine the maximum standardised uptake values (SUV) in~     prostate specific membrane antigen positron emission tomography (PSMA-PET) before ADT and 7,~     14 and 28 days after ADT.~      Phase B: To validate phase A results by comparing the PSMA-PET findings to histopathological~     analysis of regional lymph nodes acquired from radical prostatectomy specimens. PSMA-PET is~     done before ADT and at maximum SUV defined by the phase A.~   "
19347|NCT03313713|"~     This will be a randomized, placebo-controlled, clinical trial carried out on moderately~     hypercholesterolemic subjects who will consume 3 g per day of beta-glucans, in order to~     evaluate the effects on lipid profile, glycemia and intestinal function~   "
19348|NCT03313700|"~     The purpose of this study is to explore the clinical outcomes of the robotic assisted distal~     gastrectomy for patients with gastric adenocarcinoma（cT1-4a, N-/+, M0）.~   "
19349|NCT03313687|"~     International, observational registry to investigate the outcome in patients with cardiogenic~     shock. The primary aim of this study is to investigate the clinical outcome of patients in~     cardiogenic shock.~   "
19350|NCT03313674|"~     Seasonal Affective Disorder (SAD) is a subtype of Major Depressive Disorder, characterized by~     a recurrent temporal relationship between the season of year, the onset and the remission of~     a major depressive episode. Estimates of the annual prevalence state that 1-6% of the~     population will develop SAD with the larger prevalences found at greater extremes in~     latitude. SAD is most likely triggered by the shortening photoperiod experienced in the~     winter months leading to a deterioration of mood. Recent cross-sectional neuroimaging studies~     have found cellular and neurotransmitter changes in response to seasonality, ultimately~     having an impact on the affect of patients. Conversly, this study aims to investigate the~     changes in neurocircuitry related to depression and euthymic states. Patients with SAD offer~     a unique ability to study these changes since they have predictable triggers for the onset of~     depression (i.e. the winter months) and remission (i.e. the summer months).~   "
19351|NCT03313661|"~     Evaluation of the glycemic efficacy of cabergoline on diabetic patients~   "
19352|NCT03313648|"~     To observe and compare the short-term and long-term oncological outcome of laparoscopic~     hepatectomy and radiofrequency ablation in the treatment of recurrent hepatocellular~     carcinoma .~   "
19353|NCT03313635|"~     This is a single-center study intended to evaluate prealbumin (transthyretin), a marker of~     anabolic metabolism, in men with androgen deficiency (Low-T). There is emerging evidence that~     prealbumin is an indicator of anabolic, versus catabolic, metabolism, and that lower levels~     may be associated with hypogonadism.~   "
19354|NCT03313622|"~     Subjects that have a diagnosis of OCD will participate in a clinical interview and cognitive~     tasks, during which they will be exposed to their individual OC stressors or will be asked to~     make decisions related to information value and quantity while measuring neural activity and~     filming facial reactions. This will assist investigators to look for biomarkers of that~     change. This study offers a unique opportunity to develop biomarkers for key domains of OCD,~     and other neuropsychiatric disorders, that are grounded in brain neurocircuitry at the~     individual-patient level.~      Subjects will participate in a clinical interview (Day 1), and then tasks+EEG (Day 2). Day 1~     will be 4 hours or less, and Day 2 will be 2.5 hours or less.~   "
19355|NCT03313609|"~     Turkey is a developing country and its intensive care infrastructure is worse than developed~     countries. The staff is very busy at work. Intensive care has become a new science. We wanted~     to investigate burnout syndrome among physicians and other health care workers who are~     starting to work at a new intensive care medicine. Intensive care specialists in Turkey do~     not work in intensive care centers where they want. This may have a negative effect on~     physicians.~   "
19356|NCT03313596|"~     Compare the effect of liver transplantation (LT) plus ADV-TK gene therapy versus LT only in~     advanced primary hepatocellular carcinoma.~   "
19357|NCT03313583|"~     Describe the epidemiologic profile and clinical context of transfusion recipients in France.~     Describe the clinical context of transfusion.~      Describe the characteristics of the transfusion prescriptions, the use of blood products and~     the main indications for transfusion.~      Describe transfusion practice according the type of hospital stay.~   "
19358|NCT03313570|"~     Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects with~     Moderate to Very Severe Chronic Obstructive Pulmonary Disease~   "
19359|NCT03313557|"~     Open-label, non-randomised study to provide continued access to AZD1775 for patients with~     advanced solid tumours who have previously completed an AZD1775 clinical pharmacology study~     and to investigate the safety of AZD1775.~   "
19436|NCT03312556|"~     Supine hypertension is a common problem that affects at least 50% of patients with primary~     autonomic failure. Supine hypertension can be severe and complicates the treatment of~     orthostatic hypotension. The purpose of this study is to assess whether continuous positive~     airway pressure (CPAP) decreases blood pressure in autonomic failure patients with supine~     hypertension.~   "
19360|NCT03313544|"~     Prospective, monocentric clinical study. Patients selected for nivolumab therapy in AP-HM for~     melanoma and non-small cell lung cancer will be eligible. Do not include patients with~     conditions that do not allow MRI, prior cardiovascular disease with LVEF<50%, cardiomyopathy,~     history of cardiac arrhythmia, history of cardiovascular toxicity under anticancer therapy,~     coronary artery disease or stroke less than 3 months Therapeutic management will not be~     modified and treatment will be administrated as usual.~      Cardiovascular follow up will be identical to that recommended and realized in current care~     in the Cardio-Oncology unit of AP-HM. It will include clinical, biological (BNP and troponin)~     and trans-thoracic echocardiography (TTE) at baseline and then at 1, 3 and 6 months.~     Auto-antibodies against troponin I assay will be performed to avoid false negatives of normal~     blood level of troponin I at baseline and then at 6 months. Cardiac MRI will be performed as~     well at baseline and at the end of the study (6 months). MRI is the gold standard for~     ventricular function evaluation.~      Primary endpoint will be left ventricular function evolution evaluated by global longitudinal~     strain (GLS, 2D speckles tracking) in TTE. Secondary endpoints will be left and right~     ventricular function parameters: LEVF by TTE and MRI, left ventricular indexed volumes by TTE~     and MRI, right ejection ventricular function and indexed volumes by TTE and MRI, systolic~     pulmonary arterial pressure by TTE, serum troponin I and BNP, arrhythmias and conduction~     disorders on the electrocardiogram (ECG).~      Number of required subjects: GLS is recommended for following up left ventricular function~     under anticancer treatments. Based on the hypothesis of a significant GLS decrease (15%) in~     20% of cases with alpha risk of 0.05 and accuracy of 0.12 which means expected confidence~     interval of 0.08-0.32, then the number of required subjects is 50 patients.~      The inclusion period will be 18 months with a follow up if 6 months, ie a total duration of~     the study of 24 months.~   "
19361|NCT03313531|"~     This study is aims at determining the inter laboratory variation when using the thrombin~     generation assay calibrated automated thrombogram (TGA CAT). It is thus, not a clinical trial~     in its usual meaning. However, to achieve relevant test samples one patient will be treated~     with two different study drugs as part of the trial and therefore, approval by~     Läkemedelsverket is needed. Test plasma samples will be sent out to five participating~     centers in the Scandinavian countries (Gothenburg and Stockholm, Sweden, Århus Denmark, Oslo~     Norway and Helsinki Finland) and coefficients of variance (CV) and level of agreement will be~     analyzed. To obtain representative plasma samples with a wide range of thrombin generation~     capacity (TGC), blood samples will be collected from research persons that has given informed~     consent to participate in the study. To obtain plasma with low TGC, blood samples will be~     drawn from patients with severe hemophilia (n=4)(study group 1), to obtain plasma with normal~     TGC, blood samples will be drawn from healthy volunteers (n=3)(study group 2) and to obtain~     plasma with high TGC, plasma will be collected from healthy volunteers (n=3)(study group 3)~     that at previous measurements have been shown to have a TGC>2SD of the median of the control~     population. Moreover, one patient with severe hemophilia A (HA) will be treated with two~     factor FVIII concentrates, one with standard half- life (Advate™) and one with a pro-longed~     half-life (Adynovate™) at two separate occasions (Treated HA person). By taking repeated~     blood samples after administration, samples with a wide range of FVIII levels and TGC:s will~     be obtained. Moreover, the effect of using plasmas with low, normal and high TGC for~     normalization will be investigated. Plasma samples will be collected as soon as approval from~     the Swedish medical agency (SMA) has been obtained, we count on sending them to participating~     centers March 2017. All laboratory measurements, data analysis and report writing will be~     concluded before December 31 2017.~   "
19362|NCT03313518|"~     The aim of this study is to evaluate the oxidative stress and brain damage biomarkers induced~     by tDCS in patients with AD and to assess the long term neurophysiological and behavioral~     effects after repeated daily tDCS sessions for 10 days. Thirty AD patients diagnosed~     according to 2011 McKhann criteria will be randomly assigned to receive 10 real anodal tDCS~     or sham at 2mA intensity for 20 minutes per session daily. All patients will be evaluated at~     baseline, at the end of the sessions and 1, 2, and 3 months later with neurophysiological and~     behavioral examination.~   "
19363|NCT03313505|"~     Brain injury is a frequent purpose for consultation in emergency services. Management of~     brain injury is time and resource consuming, combining clinical monitoring and imaging.~      The stage prior to the management of the victims of brain injury is stratification of the~     severity, potential or proven.~      Severe brain injury requires emergent brain CT-scan, ideally within one hour of the first~     medical contact. Patients requiring this strategy present with focused neurological deficit,~     Glasgow score <15 to 2 hours after the trauma, suspicion of open fracture of the skull or~     dish pan fracture, any signs of fracture of the skull base (hemotympanum, bilateral~     peri-orbital ecchymosis), otorrhea or rhinorrhea of cerebrospinal fluid, more than one~     episode of vomiting in adults, and posttraumatic convulsion. Patients benefiting from~     anticoagulant therapy are included in this category.~      Victims of brain injury that do not fall into this category are considered less critical.~      By definition, mild traumatic brain injury :~        -  a trauma of the cephalic extremity :~        -  whose Glasgow score (30 min after the trauma or during the consultation) is 13-15,~        -  associated with one or more of the following: confusion; disorientation; loss of~          consciousness of 30 min or less; post-traumatic amnesia of less than 24 hours; other~          transient neurological abnormalities (focal signs, epileptic seizures, non-surgical~          intracranial lesion).~      Among these patients, some are considered at risk of developing intracerebral lesions.~     Nevertheless, it should be noted that the prevalence of hemorrhagic complications is~     radically different between patients with a Glasgow score of 13 and those with a score of 15.~     Thus, the recommendations suggest a brain scan without injection of contrast media within 4~     to 8 hours for patients with the following characteristics :~        -  a retrograde amnesia of more than 30 minutes,~        -  a loss of consciousness or amnesia associated with:~             -  either a risk mechanism (pedestrian overturned by a motor vehicle, ejection of a~               vehicle, falling by more than one meter),~             -  or an age> 65 years,~             -  or coagulation disorders, including the use of platelet aggregation therapy.~               Patients who fall outside this definition are considered low risk of complication~               and should not benefit of imaging.~      Data from the scientific literature show that an early brain CT-scan allows identification of~     post-traumatic lesions in this population. Nevertheless, organizational problems, including~     the availability of the imaging, radiation, and disruption of surveillance related to patient~     displacement, are limitations to this strategy. In contrast, the low cost-effectiveness of CT~     scan is often advocated in patients with mild traumatic brain injury. For example, in the~     Octopus study, 52 of 1316 patients who received CT scan after mild head trauma had an~     intracerebral lesion. Among these patients, 39 (3%) had intracerebral lesion related to~     trauma; for 13 (1%) patients, the link with the trauma was uncertain.~      In fact, the search of alternatives for a safer, more conservative, more efficient practice,~     one of the objectives of which is to limit the undue use of cerebral scanning. Thus, many~     teams have been interested in the use of biological variables to guide the decision to use~     imagery.~      Among candidate biomarkers, the S100B protein has been the subject of many evaluations which~     allow it to be used in current practice. Indeed, the increase of the S100B protein carried~     out within 3 hours following a mild head trauma makes it possible to identify the patients at~     risk of intracerebral lesion and to target the indications of imaging.~      The purpose of the registry is to describe the use, interpretation and performance of the~     S100B protein in its use at bedside in emergency medicine.~   "
19364|NCT03313492|"~     Skin cancer is the most common cancer and can be deadly, debilitating, damaging, and~     disfiguring, yet is highly preventable. In 2014, the US Surgeon General made a call to action~     about the major public health problem of skin cancer, noting potential contributions of~     behavioral science and education, and a need for investments in such efforts. Almost five~     million Americans are treated for skin cancer annually, and incidence is rising. Risk factors~     for melanoma and non-melanoma skin cancers include personal or family history of skin cancer,~     certain physical characteristics (e.g., fair skin, numerous moles), as well as excessive~     ultraviolet (UV) radiation exposure. Our work shows that skin cancer risk behaviors,~     including sunburns, indoor tanning, and lack of protection peak at age 25. Thus, young~     adulthood is an important window for skin cancer risk reduction interventions. However, young~     adults tend to be resistant to public health recommendations because, as a group, they~     perceive themselves as having more immediate priorities than disease prevention, that the~     consequences of their current health behaviors are in the distant future, and they also tend~     to be experimenters and risk-takers highly influenced by peers.~      The principal investigator developed a web-based intervention (UV4.me) that was found to~     significantly decrease UV exposure and increase skin protection behaviors among young adults~     in a randomized controlled trial of nearly 1000 participants.~      The objective of this project is to investigate the reach, effectiveness, implementation,~     maintenance, and cost of an enhanced version of that web intervention (UV4.me2) in a large~     national randomized controlled trial. The ultimate goal is to improve the skin cancer~     protection behaviors (and potentially decrease skin cancer incidence) among a national sample~     of young adults at moderate to high risk of developing skin cancer.~      Primary Aim 1. To enhance and determine intervention reach (i.e., enrollment,~     representativeness).~      Primary Aim 2. To determine the effectiveness of the enhanced intervention.~      Secondary Aim 1. To determine maintenance of the UV4.m4 and UV4.me2 interventions through~     evaluation at 6 and 12-month follow-up.~      Secondary Aim 2. To determine intervention implementation by young adults.~      Secondary Aim 3. To determine the costs of the UV4.me and UV4.me2 interventions.~   "
19365|NCT03313479|"~     Postoperative nausea and vomiting (PONV) is a distressing adverse effect that may result in~     postoperative complications including bleeding, wound dehiscence, aspiration pneumonitis, as~     well as fluid and electrolyte imbalances Incidence of PONV after general anesthesia is about~     30% in all post-surgical patients but up to 80% in high-risk patients despite advances in~     anesthetics and anesthesia techniques~   "
19366|NCT03313466|"~     The investigators will conduct a randomized, controlled trial of internet-based cognitive~     behavioral therapy (iCBT) vs usual care for insomnia. The target population is patients~     prescribed medications for insomnia who have not had a dispensation of these medications in~     the preceding six months. The primary outcomes is dispensed days supply over the subsequent~     one year. Secondary outcomes include all types of health system clinical encounters. The~     investigators hypothesize that the group randomized into iCBT will have less insomnia~     medications dispensed than usual care controls, and less clinical encounters..~   "
19367|NCT03313453|"~     This study aimed to assess the impact of air cleanser on allergic rhinitis patients and~     indoor air quality. Air cleaners will be installed in the bedrooms and living rooms of the~     mite allergic rhinitis patients who aged 18-60 years.~      Main parameters:~      - Symptom medication score of allergic rhinitis~      Supportive parameters:~        -  Visual analog scale of allergic rhinitis~        -  Quality of life score of allergic rhinitis~        -  Indoor air quality measurement~        -  Indoor allergen level measurement~   "
19386|NCT03313206|"~     The main objective will be to estimate the disease free survival (DFS) of patients with~     resectable head and neck mucosal melanomas treated by neo-adjuvant anti-PD1 followed by~     surgery, radiotherapy and maintenance immunotherapy in order to compare it to historical DFS~     results of this kind of patients treated by surgery and radiotherapy. Our primary end-point~     will be disease-free survival at 2 years~   "
19462|NCT03312218|"~     Spaced education is a promising theory-driven strategy to improve clinical competence. Our~     aim is to improve the clinical competence of Family Physicians, an outcome associated with~     the quality of care delivered to Canadians.~   "
19368|NCT03313440|"~     Some dietary fibres, including wheat fibres, have shown to increase fecal bulk and improve~     stool. In previous studies, this effect on fecal bulk was especially studied for intact wheat~     fibers. Moreover, in most studies, the wheat fiber was offered daily as a single dose in~     cereals. In this study, we investigate whether an increased intake of extracted wheat fiber,~     implemented at several time points in a normal daily dietary pattern, can also increase fecal~     bulk and improve stool frequency and consistency. Here we want to demonstrate that an~     increase in VITACEL Wheat Fiber intake will enhance fecal bulk, both wet and dry weight and~     that the enhanced wheat fiber intake will also increase stool frequency and consistency. The~     study is a double-blind crossover design in which the intervention is based on products~     enriched by VITACEL Wheat Fiber and control products. Both the control and fiber-enriched~     intervention will last for 10 days with a wash-out period of at least 4 days. The study will~     be conducted with 25 healthy male human volunteers in the age between 18-70 years old.Persons~     will be assigned to the intervention groups. In one of the intervention periods participants~     receive 'control boxes' with products low in wheat fiber and in the other period they will~     receive boxes with products enriched with VITACEL Wheat Fiber. During an intervention period~     of 10 days participants will receive 10 boxes, one for each day. In the last 5 days of the~     intervention + 1 additional day after the intervention (so in total 6 days), participants~     will collect their fecal samples to analyse fecal bulk. Daily also a diary has to be kept and~     questionnaires have to be completed to check compliance to the intervention and assess stool~     consistency, gut-related complaints.~   "
19369|NCT03313427|"~     The hypothesis of this study is that early physical therapy intervention, initiated during~     the NICU stay and up to 2 months corrected age, based on the family-centered model, could~     promote preterm infants motor development in short-term (2 months corrected age) and~     long-term (8 months corrected age).~      There is a high evidence level of different systematic reviews, which support the effectivity~     of early intervention with preterm infants.~      The principal aim of this randomized controlled trial is to evaluate the effectiveness of~     early physiotherapy intervention to promote motor development in preterm infants at 2 and 8~     months corrected age.~      The secondary purpose is to study the motor development of those preterm infants who received~     early physical therapy intervention.~   "
19370|NCT03313414|"~     This is an unblinded, observational trial of sofosbuvir-velpatasvir in adult health care~     workers who are exposed to hepatitis C virus from needlestick injury with hollow-bore~     needles.~   "
19371|NCT03313401|"~     Aflibercept is the most recently developed VEGF inhibitor with a recombinant fusion protein~     consisting of human VEGF receptor extracellular domains from receptors 1 and 2 (VEGFR1 and~     VEGFR2) fused to the Fc domain of human IgG. Although both ranibizumab and bevacizumab have~     been shown not to have harmful effects on corneal endothelium, the effect of intravitreal~     aflibercept on human corneal endothelium has not been reported so far. Considering the~     functional importance of the corneal endothelium, particularly in aged population, the~     present study was designed to evaluate the in vivo toxicity of aflibercept on human corneal~     endothelial cells in patients with neovascular AMD.~      This study showed that intravitreal injection of clinically effective doses of aflibercept~     for four times on average during the 6-month period do not induce any harmful effect on human~     corneal endothelium evaluated by specular microscopy. Further prospective, large-scale,~     prolonged studies are needed to confirm that intravitreal aflibercept can be used safely~     without any corneal toxicity to treat neovascular AMD.~   "
19372|NCT03313388|"~     This study evaluates the effects of tart cherry juice consumption on endurance exercise~     performance, fat metabolism during exercise, blood pressure, and recovery from exercise as~     assessed by muscle pain, muscle strength and electrical properties of muscle. Comparisons~     will be made to Gatorade consumption. Participants include those who are moderately active~     and have experience with cycling.~   "
19373|NCT03313375|"~     This study examines the effect of obesity and gender on postexercise hypotension with three~     different randomized exercise protocols or varying intensity. Subjects will be separated into~     obese and non-obese groups and then further by gender. From there, they will be put through a~     control, continuous exercise bout, and aerobic interval bout of exercise in a randomized~     order over three visits. Post exercise blood pressure, as well as other non-invasive cardiac~     measures will be taken over a 4 hour period.~   "
19374|NCT03313362|"~     This is a prospective, comparative, multicenter study of subjects being admitted for standard~     of care therapy in Epilepsy Monitoring Units in the Veteran's Affair (VA) Medical Centers.~   "
19375|NCT03313349|"~     Evaluating interventions for children/adolescents with Attention Deficit Hyperactivity~     Disorder (ADHD) is a field that offers many challenges. Even though psychotherapeutic~     treatment for ADHD is recommended as the first choice in many countries(1), the evidence base~     for this is inconsistent and outcome specific (2). For instance, parent training may not have~     significant effects on the core Symptoms of ADHD (3). However, trials suggest that it~     facilitates skills in other areas. One area where it is of potential value is social~     functioning (4). The randomized controlled trial (RCT)described here will test the~     therapeutic value of a package of psychological interventions designed to target social~     functioning for children and adolescents with ADHD. It will be conducted in a special school~     environment designed specifically for children with severe behavioral problems. Therefore,~     routine provision is already substantial. As a result, it was not possible to include a no~     intervention group (control group) for ethical reasons. Therefore, the value of social~     skills intervention was examined by comparing different doses of the routine intervention~     by testing a usual provision (UP) group against an enriched/need-based (ENP) form of~     provision.~   "
19376|NCT03313336|"~     A double-blind, randomized, 2-period, placebo-controlled, single-center, crossover study,~     efficacy study demonstrating the therapeutic equivalence of the test cellulose disc (matrix)~     in EMLA patch and the current commercial cellulose disc (matrix) in EMLA patch in healthy~     subjects.~   "
19420|NCT03312764|"~     The goal of this randomized controlled trial is to determine the efficacy of a digital~     diabetes prevention program for improving weight, glucose control, and secondary risk factors~     among people with prediabetes compared to an enhanced standard care plus wait-list control.~     Exploratory assessments of implementation facilitators and barriers will also be completed to~     determine strategies for integrating external diabetes-prevention interventions within~     healthcare settings.~   "
19377|NCT03313323|"~     Rationale:~      Ipilimumab, a monoclonal antibody targeting CTLA-4, is approved for the treatment of~     metastatic melanoma and significantly increases median overall survival. However, use of this~     drug is associated with immune related adverse events (IRAEs) like colitis, hepatitis,~     dermatitis, alveolitis and hypophysitis in 10-40% of the patients. In general IRAEs are~     manageable by cessation of ipilimumab in combination with treatment with corticosteroids or~     TNF-alpha blockade but they can be severe or even life-threatening. In addition, treatment~     with ipilimumab is expensive. Because of the high costs and the potential serious toxicity of~     ipilimumab, it is of great importance to identify biomarkers that correlate with clinical~     activity and can be used to select patients that will benefit from CTLA-4 blockade therapy.~      The investigators hypothesize that differences in response to treatment with ipilimumab are~     due to variability in the pharmacodynamics and -kinetics of the antibody. It is hypothesized~     that patients who do not respond to treatment with ipilimumab have lower drug levels in tumor~     tissues as compared to patients with a good response to therapy. In addition, the~     investigators hypothesize that IRAEs are associated with high drug levels in the affected~     tissue.~      To visualize molecular interactions a novel technique is used in which positron emission~     tomography (PET) is combined with labeled monoclonal antibodies. Because ipilimumab induces~     activation of T-lymphocytes it is hypothesized that uptake of 89Zr-ipilimumab in tumor~     lesions and normal tissue is different (i.e. higher) after the second administration of~     ipilimumab (3 weeks after first injection). Therefore immuno-PET scans will be performed~     after the first and after the second injection of ipilimumab.~      Objective:~      Part one: The primary objective is:~      1. To assess uptake (visual and quantitative) of 89Zr-ipilimumab in tumor lesions and~     biodistribution at two timepoints (at start of ipilimumab therapy and after the second~     injection 3 weeks later).~      The secondary objectives are:~        1. To determine the correlation between tumor targeting of ipilimumab and response to~          therapy.~        2. To assess uptake (visual and quantitative) of 89Zr-ipilimumab in normal tissues.~        3. To determine de correlation between organ targeting and toxicity~   "
19378|NCT03313310|"~     The investigators aim to pilot-test a novel social and structural-level HIV intervention for~     YMSM and YTW of color ages16-24.~   "
19379|NCT03313297|"~     The study aims to investigate effects of inhibiting glucocorticoid activation on skin~     function and wound healing in patients with type 2 diabetes. Half of patients will be given a~     drug to inhibit glucocorticoid activation and the other half will be given a placebo.~   "
19380|NCT03313284|"~     The prevalence of pre-hypertension and hypertension in the elderly is very high. Apart from~     medication, physical exercise training is a potential strategy to reduce blood pressure,~     however, the ability to perform exercise can be limited in the elderly. Hence, alternative~     non-pharmacological strategies to reduce blood pressure are necessary. Two interventions that~     have been shown to positively influence blood pressure are respiratory muscle training (RMT)~     and intermittent hypoxia (IH). Whether a combination of RMT and IH yields even better effects~     is currently unknown. Therefore, in this study, the effect of a single session of RMT with~     and without IH on blood pressure and associated cardiovascular parameters will be~     investigated in elderly subjects with pre-hypertension.~   "
19381|NCT03313271|"~     Lymphoma is the most common hematologic tumor. It is derived from lymphoid tissue, including~     Hodgkin's lymphoma(HL) and non Hodgkin's lymphoma(NHL). The treatment of lymphoma includes~     chemotherapy, radiotherapy, stem cell transplantation, targeted therapy and surgery etc. With~     the progress of treatment, the survival rate of lymphoma patients has been improved. But the~     5 year survival rate of lymphoma in China is shorter than that in United States. The reason~     is that there is still a gap between China and the United States in disease screening,~     diagnosis and treatment.~      Observational studies, especially cohort studies, are important tools for understanding~     disease progression, treatment, and prognosis in the real world. Observational cohort studies~     which involve over 500 patients are currently launched by South Korea and the United States.~     China, which has more patients, doesn't have a cohort of patients with lymphoma. So the~     primary objective of this study was to establish an observational cohort of patients with~     lymphoma in China and follow up the patients for a long period of time to provide basic~     support for clinical research and drug development, and continuously improve patient outcomes~     and quality of life. The secondary objective is to collect information about diagnosis,~     treatment, follow-up and prognosis of lymphoma.~   "
19382|NCT03313258|"~     Hypothermia amongst trauma patients is a persistent problem that increases the relative risk~     of transfusion as well as morbidity and mortality. The investigators propose to conduct a~     single-centered randomized controlled trial to determine if the use of a zero-heat flux (ZHF)~     temperature monitor can reduce the incidence of hypothermia amongst trauma patients~     discharged from the trauma bay (TB). All eligible trauma patients will be randomized to~     either a standard of care group or an active temperature monitoring group. In the active~     temperature monitoring group, a ZHF monitor will be placed on respective trauma patients to~     continuously record their temperatures after they enter the TB at a large tertiary trauma~     centre, Sunnybrook Health Sciences Centre (SHSC), in Toronto, ON. The investigators will~     determine if early continuous temperature monitoring can reduce the incidence of hypothermia~     upon discharge from the TB. Should early monitoring of severely injured trauma patients~     within the hospital improves discharge temperature, the foundation for two additional~     research studies will be laid. Firstly, the investigators will enter a vanguard phase of this~     trial and assess if early warming patients can improve morbidity and mortality in this~     patient population utilizing a multi-centered randomized controlled trial design. This will~     be further extended to test whether early monitoring can be applied in a pre-hospital setting~     (i.e. within ambulances and transport vehicles) to improve admission temperatures in the TB.~   "
19383|NCT03313245|"~     This study aims to study the relationship between diet and cognitive function among~     4-5-year-olds.~   "
19384|NCT03313232|"~     This study evaluates the clinical and molecular effect of daily exposure to low doses of the~     fragrance contact allergen oxidized R-limonene. Three groups of participants are included: 1)~     Patients with a previous positive patch test to oxidized R-Limonene, 2) patients with a~     previous doubtful patch test to oxidized R-limonene and 3) healthy controls with no contact~     allergy to oxidized R-limonene~   "
19385|NCT03313219|"~     The primary objective is to evaluate the safety and, tolerabilitytolerance, pharmacokinetices~     and immunogenicity of escalating single doses and subsequent multiple dose of Gentuximab~     Injection in patients with late recurrence of metastatic solid tumors and to determine the~     maximum tolerated dose（MTD） and dose limiting toxicities（DLT）.with single and subsequent~     multiple intravenous infusion in patients with late recurrence of metastatic solid tumors and~     to provide a basis for the protocol design of later clinical trials.~      The secondary objective is to evaluate the pharmacokinetics, pharmacodynamics and~     immunogenicity, and tumor response of multiple dose of Gentuximab Injection in patients with~     late recurrence of metastatic solid tumors.~   "
19463|NCT03312205|"~     This is an open, single-arm, phase I/phase II clinical study to evaluate efficacy and safety~     of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of hematopoietic~     and lymphoid malignancies. A total of 50 patients are planned to be enrolled over a period of~     2 years.~   "
19387|NCT03313193|"~     Background Despite advances in symptom management, children undergoing cancer treatment often~     suffer from moderate to severe symptoms of nausea/vomiting, pain, and fatigue along with~     psychological distress. Pharmacologic treatments of symptoms can cause side-effects.~     Patients, parents, and clinicians have expressed interest in including non-pharmacologic~     approaches to improve symptom management. Acupuncture/acupressure is a promising adjunctive~     therapy to usual care. More evidence is needed from well-designed trials with larger samples~     and rigorous designs in order to make definitive recommendations about the routine inclusion~     of acupressure among pediatric patients being treated for childhood cancer.~      Design and Methods 390 participants will be randomized 1:1 into 2 study arms (195 in each~     arm). Arm A participants will be offered usual care and professional acupressure five times~     weekly (15-20 minute sessions) and a parent/caregiver will be instructed in acupressure~     delivery for the child as symptoms arise. Arm B participants will receive usual care alone.~     (At the study end, Arm B parents will be offered acupressure instructions.) Children will be~     enrolled for ~30 days which can occur with one month of continuous hospital-based treatment~     or two months of intermittent hospital-based treatment (inpatient treatment or daily~     outpatient radiotherapy for Neuro-Oncology patients). Parent and child participants will~     receive a follow-up interview one month after completion of the intervention (Arm A) or the~     final symptom assessment (Arm B).~      Significance This is the first study to evaluate the effectiveness and safety of an~     acupressure intervention to decrease treatment-related symptoms in 390 patients in treatment~     for a childhood cancer.~   "
19388|NCT03313180|"~     The main objective is to assess long term safety of treatment with oral nintedanib in~     patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD).~   "
19389|NCT03313167|"~     To assess the prevalence of all (prevalent and paroxysmal) undiagnosed atrial fibrillation~     (AF) in a Japanese population with a moderate-to-high risk of stroke~   "
19390|NCT03313154|"~     Chronic hepatitis HCV-related is the most common cause of chronic liver disease in Italy.~     Patients with chronic hepatitis C present a prevalence of depressive disorders higher than~     that of the general population; moreover, it has been repeatedly demonstrated the presence of~     cognitive deficits and poor quality of life. Chronic hepatitis C therapy was based on the~     combined use of pegylated alpha-interferons (PEG-INF), and ribavirin. Recently, new~     therapeutic protocols have been introduced, and while some antiviral drugs, including the~     first-generation ones, were used only in combination with PEG-IFN and ribavirin, the second~     and third generation antiviral drugs protocols are interferon-free. However, because of the~     high cost, the access to interferon-free protocols is only for patients with advanced fibrous~     stages, or with concomitant extra-hepatic HCV-related diseases, or for transplanted patients.~     Many side effects, such as flu-like symptoms, and psychiatric symptoms (depression, anxiety,~     irritability, insomnia) are common during antiviral therapy with IFN. However, in patients~     with chronic hepatitis C, a high lifetime prevalence of major depressive disorder, panic~     disorder, and brief recurrent depression have been observed, irrespective of IFN treatment~     and the use of alcohol and narcotics; such associations between mood and anxiety disorders~     and chronic hepatitis C may reflect a high prevalence of bipolar spectrum disorders. The~     presence of severe psychopathological symptoms requires the reduction of posology and causes~     high rates of discontinuation of antiviral therapy.~      This project represents an innovative psychiatric and neuropsychological screening program~     for patients with chronic hepatitis C, eligible for antiviral therapy.~        1. Primary objectives:~             1. to verify the medium-term impact of new antiviral therapies on quality of life,~               psychological well-being and cognitive function in subjects with chronic hepatitis~               C;~             2. to verify the predictability of specific psychopathological components and specific~               determinants on compliance with new antiviral therapies.~        2. Main secondary objectives:~             1. to verify the evidence of association between various psychiatric disorders and~               cognitive deficits and chronic hepatitis C;~             2. to evaluate the relative weight of psychopathological and/or cognitive disorders on~               the efficacy of antiviral therapy and on quality of life.~   "
19391|NCT03313141|"~     The study of diaphragmatic function is usually measured by the pressures and volumes~     generated by contraction of the diaphragm, which is often difficult (cumbersome technique,~     difficulty to obtain a perfect cooperation of the subjects, and difficulty to specifically~     analyze the diaphragm compared to other accessory respiratory muscle groups). In this study,~     the investigators aimed at analysing diaphragmatic function by measuring the shortening,~     stiffness, strain and thickening of the diaphragm by ultrasound.~   "
19392|NCT03313128|"~     This is a controlled cohort study to assess the effect of improved sanitation on oral~     rotavirus vaccine performance in low-income urban neighbourhoods of Maputo, Mozambique. The~     specific hypotheses are that: (1) access to improved sanitation is associated with increased~     oral rotavirus vaccine immunogenicity; (2) enteric infection concurrent to oral rotavirus~     vaccination is associated with reduced oral rotavirus vaccine immunogenicity; and (3)~     Environmental Enteric Dysfunction is associated with reduced oral rotavirus vaccine~     immunogenicity.~      Pregnant women will be enrolled from the intervention and control arms of a previous~     sanitation trial (NCT02362932) post-intervention and will be enrolled at no later than eight~     months' gestation and then followed to 4 months of age of the infant. Blood samples and~     faeces will be taken from the infant at the time of administration of the first dose of the~     oral rotavirus vaccine and four weeks after the second dose of the vaccine.~      The primary outcome of interest in the study is oral rotavirus vaccine immunogenicity among~     participating vaccinated infants. Seroconversion is defined as a ≥ fourfold rise in serum~     anti-rotavirus IgA titers between first dose of oral RV vaccine and 4 weeks (+/- 1 week)~     after second dose of oral RV vaccine. Enteric infections are defined as the presence of ≥ 1~     of the following enteric infections in stool: adenovirus 40/41, rotavirus A, norovirus~     GI/GII, Salmonella spp. (including serovars Typhi and Paratyphi), Campylobacter spp. (C.~     jejuni, C. coli, C. lari), Shigella spp. (S. boydii, S. sonnei, S. flexneri, S. dysenteriae),~     Clostridium difficile Toxin A/B, enterotoxigenic Escherichia coli (ETEC) LT/ST, E. coli O157,~     Shiga-like toxin-producing E. coli (STEC) stx1/stx2, Yersinia enterocolitica, Vibrio~     cholerae, Giardia lamblia, Entamoeba histolytica, and Cryptosporidium spp. (C. parvum, C.~     hominis). Environmental Enteric Dysfunction is measured via a combined disease activity score~     including faecal markers of intestinal inflammation and permeability: neopterin, α-1~     antitrypsin, and myeloperoxidase in stool.~   "
19393|NCT03313115|"~     The purpose of this study is to analyze a multi-component sleep/wake protocol for~     optimization of environmental factors (noise, light, nursing activities) as well as~     non-environmental factors (pain, mechanical support devices, procedures) to improve quality~     of sleep and decrease incidence of ICU delirium in the Cardiovascular and Surgical ICU~     (CVICU/SICU).~   "
19394|NCT03313102|"~     Giant-cell arteritis (GCA) is the most frequent vasculitis after 50 years. Corticosteroid~     therapy is the reference treatment for GCA. This treatment is highly effective but must be~     maintained for 12 to 24 months to avoid relapses, which causes the onset of numerous adverse~     effects in this elderly population [1].~      Currently clinicians have no way to estimate this risk of relapse during the treatment of~     GCA.~      Invariant T lymphocytes associated with the mucous membrane (MAIT), whose role in~     vasculitides has recently been shown [2] and which produce IL-17 and IFN-γ [3], two key~     cytokines in the pathophysiology of GCA [4-6] could be implicated in the pathophysiology of~     GCA and could constitute a predictive marker of relapse.~      Our hypothesis is that blood MAIT are recruited in the artery wall in patients with GCA and~     that the number of circulating MAIT in the blood falls and then returns to normal if the~     corticoids are effective.~      Given that it will be necessary to include a large number of patients to show that the~     persistence of a low number of circulating MAIT in patients treated with corticoids is a~     predictor of relapse, we propose, as the first step, to carry out a pilot study to obtain~     preliminary data on these new markers.~      The study is classified as interventional because a lot of blood samples are taken~   "
19395|NCT03313089|"~     The effectiveness of micronutrient powders or MNP as a strategy for the prevention of~     micronutrient deficiencies has been described in the literature. However, few studies have~     shown the impact of the inclusion of other simultaneous actions on the different dimensions~     of food and nutritional security (as in the case of the project Papas más nutritivas) that~     will contribute to the improvement of nutritional status, obtaining potentially greater~     benefits.~      The objective is to establish the existence of difference in hemoglobin values (and other~     biochemical parameters as secondary outcomes) among children aged 6 months to 5 years who~     receive home fortification with micronutrient powders (MNP) belonging to the project Papas~     más nutritivas, and children with home fortification with MNP but not belonging to the~     project.~   "
19396|NCT03313076|"~     Interventional trial employing a 2x2 factorial design to test the efficacy of Vitamin D and~     n-3 fatty acids [Polyunsaturated fatty acids (PUFAs)] to prevent chronic pain following major~     thermal burn injury.~   "
19397|NCT03313063|"~     Preeclampsia is a systemic pregnancy disorder and is associated with an increased~     cardiovascular risk later in life. This study will characterize myocardial tissue in patients~     after preeclampsia compared to controls and investigate potential functional and structural~     changes in the heart of preeclamptic women primarily with two methods: cardiovascular~     magnetic resonance imaging and echocardiography. A comparison between these two methods,~     where appropriate, is also envisaged.~   "
19398|NCT03313050|"~     This is a 2-stage, phase 1/2, randomized, active-controlled, observer-blinded study with a~     2-arm parallel design in each stage.~      In Stage 1 healthy adults 50 to 64 years of age with no history of pneumococcal vaccination~     will be randomized equally to receive either a single intramuscular dose of multivalent~     pneumococcal conjugate vaccine or a licensed tetanus, diphtheria, acellular pertussis~     combination vaccine (Tdap) (control group).~      In Stage 2 healthy adults 65 to 85 years of age previously vaccinated with Prevnar 13 >=2~     months prior to investigational product administration will be randomized equally to receive~     either a single intramuscular dose of multivalent pneumococcal conjugate vaccine or the~     licensed 23-valent pneumococcal polysaccharide vaccine (control group).~   "
19399|NCT03313037|"~     This is a Phase 2, randomized, double-blinded study with a 2-arm parallel design. Healthy~     adults aged 60 through 64 years of age with no history of pneumococcal vaccination will be~     randomized equally to receive either a single intramuscular dose of multivalent pneumococcal~     conjugate vaccine followed 1 month later with a dose of saline or Prevnar 13 followed 1 month~     later with a dose of PPSV23 (control group).~   "
19400|NCT03313024|"~     This study will investigate the interplay of different immune cells and placental cells as~     well as their potential for the development of pregnancy complications. In particular, the~     translation of the uteroplacental syndrome into a maternal syndrome, considered in the~     multifactorial pregnancy disorder preeclampsia, will be investigated. Immune cell subtypes~     are causally involved in the formation and translation of preeclampsia by inducing an~     endothelial dysfunction which leads to cardiovascular damage.~   "
19401|NCT03313011|"~     The purpose of this study is to identify and distinguish two different types of Progressive~     Apraxia of Speech through clinical imaging and testing.~   "
19402|NCT03312998|"~     Recording incidence of metal failure in transpedicular screws fixation of dorsal umbra spine~     fracture during first year follow up~   "
19403|NCT03312985|"~     Background: Dr. Shi recently proposed a new technique as Ossification of anterior~     decompression surgery, which is also called anterior controllable antedisplacement and fusion~     (ACAF) , for ossification of the posterior longitudinal ligament (OPLL) and cervical canal~     stenosis（CSS）. Yet, the effectiveness and safety should be further studied.~      Purpose: The aim of this study is to compare the effectiveness of clinical outcomes between~     ACAF surgery and Anterior cervical corpectomy decompression and fusion（ACCF）in patients with~     OPLL and CSS . A study hypothesis is that ACAF surgery outcomes will be equal even better and~     lower surgical complications which compared to ACCF surgery.~      Methods: This study is a randomized clinical trial with randomized, controlled, multicenter~     research design. The OPLL patients will be randomly assigned in one of the two treatment~     groups: ACAF surgery and ACCF surgery. Five outcome measures will be collected pre-operative~     for baseline, and then at1, 12, 24, 48, 96,240weeks post-operative follow-up visits,~     including: (1)JOA) .(2)VAS. (3)NURIC Graded .(4)NDI . (5) radiological parameter. After~     randomization, the ACAF group will receive anterior controllable antedisplacement and fusion~     and the ACCF group will receive anterior cervical corpectomy decompression and fusion.~   "
19404|NCT03312972|"~     This purpose of this study is to evaluate the safety and effectiveness of a technique called~     focal high-dose-rate (HDR) brachytherapy as treatment for prostate cancer that has come back~     in the prostate after prior radiotherapy. The study will examine the safety and efficacy of~     the treatment. The type of radiation that participants in this research will receive is~     targeted directly at the areas of the prostate where recurrent disease is evident, while~     avoiding treatment of the normal appearing prostate. This involves the placement of a~     radioactive material in the affected area of the prostate temporarily, where it remains for a~     short period of time, and then is subsequently removed using a minimally invasive technique~     called HDR Brachytherapy.~   "
19405|NCT03312959|"~     Most of the ophthalmic procedures are performed under local anesthesia as the patient is~     often elderly and with diseases. This may increase the risk of morbidity and mortality under~     general anesthesia. Different eye blocks have been practiced with great success. Moreover, it~     is associated with less hemodynamic instability, less respiratory depression, better~     postoperative pain relief, and less nausea and vomiting than general anesthesia. It is also~     associated with a reduction in stress response, maintained oxygen saturation and~     cardiovascular stability, in addition to the production of good akinesia and anesthesia~     alleviating occulo-medullary reflexes, all make local anesthesia more superior and safe~     technique.~   "
19433|NCT03312595|"~     The primary objective of this study is to determine the outcomes of patients who receive a~     certain type of skin substitute called RestrataTM Wound Matrix (Restrata™). Results of this~     study may be used to make decisions on whether to conduct additional studies on this~     particular wound matrix product. RestrataTM has been cleared by the Food and Drug~     Administration for use in certain types of ulcer treatments, including the type that will be~     part of this study (diabetic foot ulcers).~   "
19406|NCT03312946|"~     OBJECTIVE: To evaluate the efficacy of vibro-oscillatory therapy through an electromedical~     equipment in improving body contour and appearance of cellulite.~      SUBJECTS AND METHODS: A prospective and comparative longitudinal clinical study will be~     performed in 30 women with cellulitis. Patients will be submitted to data collection and~     evaluation and before and after vibration-oscillatory therapy.~      HYPOTHESES: Patients are expected to show improvement in body contour and cellulite after~     vibration-oscillatory therapy.~      STATISTICAL ANALYSIS: A descriptive analysis will be done before and after~     vibration-oscillatory therapy, with frequency tables for categorical and descriptive~     variables (mean, standard deviation, median, minimum and maximum values) for continuous or~     numerical variables. In order to compare the main variables between the groups and the~     collection times, the analysis of variance (ANOVA) for repeated measures will be used.~     Tukey's test will be used to compare the groups. The significance level adopted for the~     statistical tests will be 5% or p <0.05.~   "
19407|NCT03312933|"~     This is a prospective randomized, control trial investigating ankle pain resulting from the~     use of CAM Walking Boots.~   "
19408|NCT03312920|"~     The purpose of this study is to investigate whether learning can be accelerated and~     associative memory performance improved in healthy subjects by applying transcranial Direct~     Current Stimulation (tDCS) during a Face Name memory task.~   "
19409|NCT03312907|"~     The purpose of this study is to assess whether co-administration of belimumab and a single~     cycle of rituximab will optimize treatment with belimumab, which will result in improvements~     of clinical status with a favorable safety profile, by comparing subjects randomized to~     belimumab plus rituximab versus belimumab plus rituximab-placebo. Approximately 200 subjects~     will be randomized in a 1:2:1 ratio to 1 of 3 treatment arms; belimumab plus~     rituximab-placebo (Arm A, control), belimumab plus rituximab (Arm B, combination), or~     belimumab plus standard therapy (Arm C, reference). Arm A and Arm B will be double-blinded~     and Arm C will be open-labeled. The open-label arm will provide a qualitative reference to~     standard therapy. Belimumab will be administered as subcutaneous (SC) and rituximab-placebo~     or rituximab will be administered by intravenous (IV) infusions. The total duration of the~     study is for 104 weeks. Double-blinded phase will be for 52-weeks with subjects from Arm A~     and B who cannot tolerate discontinuation of immunosuppressant or taper of corticosteroids.~     Subjects in Arm C will continue to receive belimumab SC and their stable immunosuppressant~     during Weeks 53 through 104.~   "
19410|NCT03312894|"~     The purpose of this study is to evaluate the efficacy of TAK-653 compared with placebo in~     maintaining the effect of ketamine treatment on depressive symptoms.~   "
19411|NCT03312881|"~     Some children experience chronic pain that is related to damage or diseases that affect the~     nerves that send pain signals. This is known as neuropathic pain. This is not well understood~     and can be difficult to diagnose. It can often produce unusual feelings such as sensitivity~     of the skin to light touch. Neuropathic pain is often severe and difficult to treat, and can~     affect quality of life for the child and family. This study aims to better characterise the~     symptoms and signs, and impact of neuropathic pain in children.~   "
19412|NCT03312868|"~     This project aims to propose a new approach in the treatment of solitary plasmacytoma:~     hypofractionated irradiation alone with stereotactic technique that may contribute to the~     successful treatment of this disease.~      This work aims to apply this new technique with the primary objective of reducing the~     progression-free survival for multiple myeloma of patients treated for solitary plasmacytoma,~     as well as quantify overall survival, local control, toxicities and quality of life in a~     phase I trial / II.~   "
19413|NCT03312855|"~     The main objective is to evaluate the efficacy and safety of treatment with 2 doses (80 and~     160 mg) of Revacept versus placebo in patients with stable coronary artery disease undergoing~     PCI.~   "
19414|NCT03312842|"~     This is a phase Ia/Ib, open-label, multiple-dose, dose-escalation and expansion study to~     evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of CS1001 in~     subjects with advanced solid tumors.~   "
19415|NCT03312829|"~     Sepsis is the body-wide response to infection. People who develop sepsis have an increased~     risk of dying. One of the greatest challenges in sepsis is determining what is the pathogen~     (bacteria or virus for example) in a timely manner so the most specific antibiotics can be~     given to treat the infection. Patients presenting to the hospital and the intensive care unit~     often have lung infections. In this study the investigators plan to develop new techniques to~     rapidly (less than 6 hours) identify bacteria growing in the airways of patients on~     ventilators. The investigators will obtain these samples by suctioning the airways (a routine~     procedure) and comparing the bacterial cultures grown by novel culture media with the usual~     techniques in the hospital microbiology laboratory. At the same time the investigators will~     collect a blood sample. This blood sample will be used to isolate the bacterial genetic~     material and use this to compare with bacteria grown on the culture media from the clinical~     and the research laboratory. The investigators will also collect information on the patient's~     course in hospital. These pilot study results will allow us to integrate this new technique~     into routine patient care.~   "
19416|NCT03312816|"~     The study is a randomised, double-blind, placebocontrolled, parallel dose-response study with~     four study arms. Sixty subjects will be randomly allocated to consume study products~     containing varying amounts of plant sterol (PS) oxidation products (POP) or placebo for 6~     weeks.~   "
19417|NCT03312803|"~     A prospective study comparing the use of mini-autogenous skin grafts and skin homograft~     versus autogenous skin grafts for covering post burn wounds in children.~   "
19418|NCT03312790|"~     Nowadays, augmented reality (AR) has gained attention but little is known concerning its~     repercussion in individuals when considering some mental and physiological aspects.~     Therefore, the aim of this study was to investigate the effects of AR glasses on some~     cognitive and physiological functions in an attempt to determine its safety for workers.~   "
19419|NCT03312777|"~     This study evaluates the analgesic effect of Omnitram and tramadol during concurrent~     administration of paroxetine. Paroxetine administration is expected to diminish the analgesic~     effect of tramadol, but not Omnitram. Each participant will receive paroxetine before and~     during treatment with Omnitram, tramadol, and placebo.~   "
26777|NCT03216486|"~     The purpose of this study is to investigate the effect of BPS804 on strength/quality of bone~     in patients with Type I, III or IV Osteogenesis imperfecta using a special type of CT~     scanner. Participants will be treated for 1 year.~   "
19421|NCT03312751|"~     The purpose of this study is to expand the knowledge on the efficacy and safety of emapalumab~     (previously known as NI-0501) as a treatment for primary haemophagocytic lymphohistiocytosis~     (HLH) patients, with special focus on long-term outcome and quality of life assessments.~     Emapalumab can be administered as the first-line therapy, to patients not previously treated~     with the current standard of care, or can be given to patients who have either failed or were~     unable to tolerate the available standard of care.~      Emapalumab is to be administered until the start of conditioning, with an anticipated~     duration ranging from a minimum of 4 weeks to approximately 12 weeks and not exceeding 6~     months.~      After treatment completion, patients will continue in the study for long-term follow-up until~     1 year after either HSCT or last emapalumab infusion (if HSCT is not performed).~   "
19422|NCT03312738|"~     This study aims at evaluating the safety and efficacy of everolimus plus exemestane in~     Chinese postmenopausal women with ER+ HER2- ABC after recurrence or progression on letrozole~     or anastrozole.~      The rationale of this study is based on the following:~        -  Proven everolimus activity in breast cancer in combination with exemestane~        -  Efficacy and manageable safety profile of everolimus in combination with exemestane in~          the Asian subpopulation of BOLERO-2~   "
19423|NCT03312725|"~     Flow disruption is a new endovascular approach for treatment of both ruptured and unruptured~     intracranial aneurysms, which involves placement of an endosaccular device (WEB) which~     modifies the blood flow at the level of the neck and induces intraaneurysmal thrombosis. The~     WEB was designed to treat wide-neck bifurcation aneurysms. This observational study will~     collect data about the routine practice in one center of using the WEB in ruptured and~     unruptured intracranial aneurysms. The primary objective is to evaluate its efficacy by~     assessing the anatomic outcome during follow-up.~   "
19424|NCT03312712|"~     The purpose of this study is to validate the method of analysing Positron Emission Tomography~     (PET) images to assess lung inflammation. Development of novel therapeutic drugs requires a~     biomarker which is sensitive to the underlying disease and can respond to therapeutic~     interventions. PET is a potential imaging biomarker which can target molecular and cellular~     processes. There is currently no standardised method of analysing PET lung data and a lack of~     validation for the existing techniques.~      This study is divided in to two parts. Part A aims to determine the best method to perform~     18F-FDG PET/CT lung analysis and how it correlates with cell counts from bronchoalveolar~     lavage (BAL) samples taken from participants with active pulmonary sarcoidosis.~      Part B will compare imaging data from healthy volunteers who have either undergone a~     Lipopolysaccharide (LPS) challenge (whereby the lung is temporarily inflamed) or saline~     equivalent to determine whether lung inflammation can be detected by 18F-FDG PET/CT. No~     medications will be given and patients will not be asked to stop or change existing~     medication.~   "
19425|NCT03312699|"~     The purpose of this study is to use an existing, unique clinical cohort: the longitudinal~     cohort of younger (21-40 years) and elderly (>65 years) subjects whose yearly influenza~     vaccine responses have been studied extensively since 2007, to gain molecular and cellular~     mechanistic insights into the impaired vaccine responses in the elderly.~   "
19426|NCT03312686|"~     This pilot study will explore whether treatment of eosinophilic inflammation in the esophagus~     is associated with an improved distensibility of the esophagus. Furthermore, previous studies~     of the esophagus using EndoFlip only measured distensibility of the distal esophagus,~     specifically the distal esophagus and esophagogastric junction. Eosinophilia in EoE has been~     demonstrated to affect both upper, middle and lower esophagus. The aim is to measure~     distensibility both proximal and distal, before and after treatment.~   "
19427|NCT03312673|"~     The objective of the study is to determine whether poor control of asthma is related to an~     emotional deficit such as alexithymia. The hypothesis is that there is a correlation between~     the severity of asthma, its control, and the degree of emotional deficits.~   "
19428|NCT03312660|"~     This is an exploratory cluster randomized controlled trial to evaluate the effect of a kefir~     beverage, enriched with prebiotics components, on immunity, lipid profile and adiposity in a~     population-based study, using the family as the intervention unit.~   "
19429|NCT03312647|"~     The investigators aim to study the prevalence of adverse reactions of anti-tuberculosis (TB)~     drugs in latent tuberculosis infection (LTBI), and determine the risk factors of anti-TB~     drug-related toxicity in LTBI in Korean health care workers(HCWs).~   "
19430|NCT03312634|"~     Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease~     characterized by heterotopic ossification (HO) often associated with painful, recurrent~     episodes of soft tissue swelling (flare-ups) that lead to ankyloses of major joints with~     cumulative and irreversible loss of movement and disability.~   "
19431|NCT03312621|"~     Special opportunities exist in vulnerable populations with chronic conditions to better~     understand what life course factors can facilitate attainment of optimal health and~     development. One such opportunity arises in the life of an adolescent or young adult when~     they transition their care from pediatric to adult health providers and systems, referred to~     as health care transition. Experts generally agree that health care transition is often~     unsuccessful and associated with a variety of adverse outcomes. Adverse outcomes of~     unsuccessful health care transition include foregone or delayed medical care and having no~     identified adult medical home after leaving pediatrics. This foregone and delayed care can~     result in potentially preventable costly utilization of hospital emergency and inpatient~     services. Particularly concerning is increasing evidence that for some youth, transition from~     pediatric to adult medical care is a high-risk period for mortality. In addition to the~     adverse effects on individuals, unsuccessful health care transition also likely has economic~     consequences, particularly given that the majority of health care spending is already~     allotted to individuals with chronic conditions. These problems are even greater for low~     income and minority youth, with the District of Columbia having the highest level of unmet~     transition needs in the U.S.~   "
19432|NCT03312608|"~     In degenerative cervical myelopathy (DCM) the dynamics of disease progression and the outcome~     after surgical decompression vary inter individually and do not necessarily correlate with~     radiological findings. By better characterization of the underlying pathophysiology this~     study aims to improve diagnostic power in DCM using Navigated transcranial magnetic~     stimulation (nTMS).~   "
26778|NCT03216473|"~     This clinical study evaluates the efficacy and safety of Neuronox compared with Botox in~     adults with essential blepharospasm.~   "
19437|NCT03312543|"~     This research study will test how well a light therapy mask works for women with mild to~     moderate hyperpigmentation (brown spots) and moderate to severe facial wrinkles, as compared~     to a sham or inactive investigational light therapy mask. The study will also test if the~     light therapy mask causes any irritation. For the first 12 weeks of the study, participants~     will use the assigned mask, along with a provided cleanser and sunscreen. For the second 12~     weeks of the study, participants will use just the cleanser and sunscreen.~   "
19438|NCT03312530|"~     This open-label, randomized, multicenter, triple-arm Phase Ib/II study is designed to assess~     the efficacy, safety, tolerability, and pharmacokinetics of cobimetinib administered as a~     single agent (Arm A), cobimetinib plus venetoclax (Arm B), and cobimetinib plus venetoclax~     plus atezolizumab (Arm C) in participants with relapsed and refractory multiple myeloma. Two~     successive cohorts will evaluate the safety of cobimetinib plus venetoclax and that of~     cobimetinib plus venetoclax plus atezolizumab in the selected population during the safety~     run-in phase of the study. Once the dose levels have demonstrated acceptable safety during~     this phase, randomization will begin for all treatment arms (Arms A, B, and C).~   "
19439|NCT03312517|"~     Phase IV 3-Way Double-blind, Randomized, Crossover Study to Compare the Awakening Threshold~     Effects (responsivity) of Belsomra 10 mg and 20 mg to Placebo in non-elderly Insomniacs~   "
19440|NCT03312504|"~     The purpose of this study is to evaluate the effectiveness of a neuromuscular training~     program in decreasing sport and recreational injuries and improving healthy outcomes in~     junior high school students (grades 7 to 9). The neuromuscular training program is~     implemented as a 15-minute warm-up at the beginning of the students' physical education~     classes over a three-month period. This study is a randomized controlled trial design,~     involving twelve schools over a three-year period. Upon enrolment into the study, schools are~     randomly assigned to the intervention (neuromuscular training) group, or the control group.~     The control group includes a standard-of practice warm-up consisting of aerobic components~     and static stretching.~      A study athletic therapist visits the schools each week to assess and record information on~     any injuries sustained by study participants. Baseline health and physical fitness is~     measured at baseline, and again at 3-month follow-up in study participants to assess changes~     over the course of the program.~   "
19441|NCT03312491|"~     Acetabular fracture are common in elder patients and high energy trauma in younger one.~      However, the fracture deplacement induces incongruity between cotyloid cavity and femoral~     head. Anatomic reduction and osteosynthesis of these fracture are technically difficult .~      3D printing ease the process of operating planification or implant fabrication. The 3D~     impression allows to obtain a model on the scale of the pond of the patient allowing to pre~     mold plates on the anatomy of the patient before he is operated with the aim of decreasing~     the surgical time and improving the quality of the reduction.~   "
19442|NCT03312478|"~     Primary Objective:~      To measure the association between a parental history of diabetes and the odds of an~     offspring being Type 1 diabetics.~      Secondary Objectives:~        -  To document the profile of Type 1 diabetes patients.~        -  To document the glycemic parameters (Fasting blood glucose [FBG] and glycosylated~          hemoglobin [HbA1c]) of Type 1 diabetes.~        -  To capture the current therapeutic management.~   "
19443|NCT03312465|"~     The objectives of this study are to confirm safety and performance of the Anatomical Shoulder~     Domelock System when used in hemi or total shoulder arthroplasty by analysis of standard~     scoring systems, radiographs and adverse event records.~   "
19444|NCT03312452|"~     A prospective, analyst-blinded, randomized control trial to assess the incidence of~     intravenous (IV) fluid over-administration in the setting of pediatric dental surgeries.~     Anesthetists will be randomized to either administer their IV fluid through an infusion pump~     or a gravity drip device.~   "
19445|NCT03312439|"~     The number of elderly will increase rapidly in Europe in the next 30 years, which affects the~     country's economic and social development, welfare, health care, and also the individuals.~     Future challenges include creating opportunities for people to maintain a high well-being in~     later stages of life, and coping with diseases and disability. Physical exercise and avoiding~     obesity have the potential to increase quality of life in the elderly by preventing CVD and~     stroke.~      The proposed project is a intervention study where the overarching aim is to evaluate whether~     a primary prevention with the focus of decreasing obesity and increasing objective measures~     of physical activity will decrease the future risk of the endpoints cardiovascular disease,~     stroke, diabetes, falls, fractures, dementia and death, in a population based cohort of~     70-year-old women and men.~      Specific aims: In a population based cohort of 5000, 70-year old women and men;~        1. Investigate the association between risk factors assessed at baseline, with focus on~          objective measures of physical activity and body fat distribution, and the endpoints~          described above.~        2. To investigate whether individuals given the prevention will have a lower future risk of~          the endpoints described above than 70-year olds in general Swedish population, after~          adjustments for differences in the different covariates at baseline.~      In a second part, a follow up will be conducted after 5 years where all participants will be~     tested again. One aim is to evaluate whether the changes in the risk factors assessed at~     baseline, with focus of objective measures of physical activity and body fat distribution,~     are associated with the risk of CVD and stroke. We will also again investigate whether the~     intervention give will influence the future risk of non-communicable disease.~   "
19446|NCT03312426|"~     The purpose of this study is to investigate the effect of a light meal and a high-fat meal on~     the bioavailability (absorption) of of BMS-986205 commercial tablet in healthy participants.~     Eligible participants will receive a single dose of BMS-986205 under fasted or fed (high-fat~     meal or light meal) conditions on Day 1 and Day 15. The safety, tolerability and movement of~     the BMS-986205 into, through and out of the body (pharmacokinetics/PK) under these conditions~     will be assessed.~   "
19447|NCT03312413|"~     Maintenance of a remifentanil infusion during anesthetic emergence has been reported to~     decrease the incidence of coughing and thereby help to ensure a smooth emergence. It may,~     however, cause respiratory depression and possibly delay emergence. The purpose of this study~     was to investigate the effect of different dose of dexmedetomidine infusion on cough~     suppression during emergence from general anesthesia in patients undergoing thyroid surgery.~      American Society of Anesthesiologists physical status I-II adults undergoing elective~     thyroidectomy under general anesthesia are recruited and randomly allocated to receive~     dexmedetomidine iv infusion of 0.2μg·kg-1·h-1 (Group D1, n = 100), 0.5μg·kg-1·h-1 (Group D2,~     n = 100), 0.7μg·kg-1·h-1 (Group D3, n = 100) or saline (Group C, n = 100). Primary outcome is~     the incidence of coughing during emergence. Second outcomes include severity of coughing,~     which is assessed using a four-point scale; Ramsay score, Bruggrmann comfort scale score, VAS~     pain score are recorded. The respiratory rate (RR), heart rate (HR), and mean arterial~     pressure are also recorded.~   "
28356|NCT03195816|"~     This is a non-pharmacological study evaluating the impact of a computerized cognitive~     stimulation program on verbal learning and on the progression white matter hyperintensities~     in elderly with mild cognitive impairment.~   "
19448|NCT03312400|"~     Background:~      DNA is a structure in the body. It contains data about how the body develops and works.~     Telomeres are found on the end of chromosomes in DNA. Some people with short telomeres or~     other gene changes can develop diseases of the bone marrow, lung, and liver. Researchers want~     to see if low doses of the hormone drug danazol can help.~      Objective:~      To study the safety and effect of low dose danazol.~      Eligibility:~      People ages 3 and older with a telomere disease who have either very short telomeres and a~     specific gene change. They must also show signs of aplastic anemia, lung, or liver disease.~      Design:~      Participants will be screened in another protocol.~      Participants will have:~        -  Medical history~        -  Physical exam~        -  Blood tests~        -  Lung exam. They will breathe into an instrument that records the amount and rate of air~          breathed in and out over a period of time.~           6-minute walking test.~        -  Abdominal ultrasound and liver scan. These tests use sound waves to measure the fibrosis~          in the liver.~      Some participants will have:~        -  Pregnancy test~        -  Small sample of the liver removed~        -  Bone marrow biopsy. The bone will be numbed and a small needle will take a sample of the~          marrow.~      All participants will have hormone levels checked.~      All child participants will see a pediatric endocrinologist. Children may need to have a hand~     x-ray.~      We will monitor patients for 6 months before starting danazol.~      Participants will take danazol by mouth twice a day for 1 year.~      Participants must return to the clinic at 6 months and 12 months while on danazol and 6~     months after stopping it. They will have blood and urine tests, a lung exam, abdominal~     ultrasound, and liver scan.~   "
19449|NCT03312387|"~     Half of heart failure patients have preserved ejection fraction (HFpEF). Like patients with~     reduced ejection fraction (HFrEF), HFpEF patients suffer from exercise intolerance (low~     VO2max), which reduces physical function, quality of life, and survival. Strikingly, there is~     no medication proven to increase survival for HFpEF patients. Whereas exercise intolerance in~     HFrEF patients is the result of cardiovascular limitations, physical dysfunction in HFpEF~     patients is largely the result of peripheral abnormalities in skeletal muscle. Indeed,~     research in HFpEF patients identified that physical function and VO2peak are directly related~     to leg lean mass, and drugs focused on improving cardiovascular function have failed to~     improve VO2peak. Unfortunately, no therapy has been identified for this population that can~     concurrently improve cardiovascular and muscle health. The need for improved muscle therapies~     is reinforced by the fact that HFpEF patients are commonly older adults who are predisposed~     to muscle wasting. Strategic essential amino acid (EAA) ingestion has been shown to improve~     the adaptive response of muscle to exercise. Therefore, the investigators will determine, in~     HFpEF patients, the extent to which ingesting a strategic mixture of EAAs during an acute~     aerobic exercise training program enhances the response to this exercise strategy.~   "
19450|NCT03312374|"~     By monitoring the serum ctDNA mutational profile using NGS, the present clinical trial aims~     to elucidate the correlation between the postoperative ctDNA status and the prognosis of~     patients with early and intermediate-stage colorectal cancer, and explore the possibility of~     clinical utility of serum ctDNA as a clinical index to predict postoperative relapse.~   "
19451|NCT03312361|"~     To determine if a prolonged high altitude simulation test (HAST) lasting two hours,~     identifies more patients at risk of respiratory failure than the standard HAST lasting 20~     minutes, in patients with neuromuscular disease (NMD) and severe pulmonary restriction. To~     evaluate the safety of supplemental oxygen administered in those with a positive HAST in the~     NMD population.~   "
19452|NCT03312348|"~     A variety of different diseases may cause a limp in a child, and in younger children it is~     particularly challenging to isolate the area affected. Children of this age group are unable~     to identify a specific region of pain, so clinical examination and parental interpretation is~     the only method of localising the area of discomfort. Potential problems that may affect~     children include inflammation, fractures, infection, juvenile arthritis or movement in the~     growth plate in the hip, among other diseases. Aside from an obvious source of injury, it is~     challenging for a clinician to distinguish between these different potential causes or the~     area of the problem without repeated visits, non-specific blood tests and the use of x-ray~     imaging: a form of radiation that carries with it a small risk of carcinogenic effect. Once a~     region of the lower limb is identified, an x-ray image of the affected area is often taken;~     however, it is not possible to image the entire leg, so the importance of the initial~     examination by a clinician is evident. The aim of this research project is to assess the~     potential of high resolution infrared (IR) imaging technology in the identification of a~     focus for the cause of a limping child. The IR camera used for imaging is able to observe an~     entire limb, so the need to localise an area for imaging would be removed. In addition, if~     successful, infrared imaging could reduce the number of children exposed to x-ray radiation~     unnecessarily, whilst stream-lining medical practice by reducing the time to make a diagnosis~     along with unnecessary visits and tests. We aim to explore whether non-invasive IR~     thermographic camera imaging assists with the clinical diagnosis in children presenting with~     an acute limp. This study represents a pilot evaluation as a test of concept.~   "
19453|NCT03312335|"~     Systemic lupus erythematosus (SLE) is an autoimmune disease with multifactorial genesis.~     Recent research suggests a numerical and functional deficit of regulatory T (Treg) cells as~     an important contributing factor to the pathology seen in SLE. Treg cells play important~     roles in dampening overt stimulation of effector cells, as seen in many autoimmune diseases.~     As Treg cells are highly dependent on interleukin-2 (IL-2), application of low doses of IL-2~     leads to markedly increased numbers and improved functionality of Treg cells in mice and~     humans. Several clinical trials investigated the safety of low-dose IL-2 treatment in~     different autoimmune diseases, including SLE. The trials conducted so far mainly focused on~     an increase in Treg cells after IL-2 treatment, not evaluating in detail the effects on other~     immune cells, presumably also playing important roles in the pathogenesis of SLE. For this~     reason, the investigators of this trial aim to conduct a complete phenotyping of cellular and~     soluble components in the blood of SLE patients treated with low-dose IL-2. Furthermore, the~     investigators want to offer this promising treatment to SLE patients in a controlled~     framework of an investigator initiated clinical trial.~   "
22288|NCT03275298|"~     The ESME OVR Data Platform is a multi-center real life database using a retrospective data~     collection process in 18 French Comprehensive Cancer Center (FCCC) over 20 sites). This~     database compiles data from Patient's Electronic medical records (EMR), inpatient~     Hospitalisation records and Pharmacy records.~   "
19454|NCT03312322|"~     Chronic obstructive pulmonary disease is a leading cause of morbidity and mortality~     worldwide.~      Pulmonary rehabilitation effectively improves outcomes in patients with chronic respiratory~     disease. There is a link between training intensity and physiological improvements following~     pulmonary rehabilitation. However, high intensity training is not sustainable for every~     patients.~      Therefore, actual strategies for pulmonary rehabilitation aimed at decreasing dyspnea to~     improve muscle work.~      Electrical muscle stimulation is widely used during rehabilitation to promote muscle function~     recovery. Transcutaneous electrical nerve stimulation was recently used to relief dyspnea and~     improve pulmonary function in patients with chronic respiratory disease. Moreover, spinal~     anesthesia with fentanyl has been shown to be effective in improving exercise tolerance in~     patients with chronic obstructive pulmonary disease (inhibiting group III and IV muscle~     afferents). As transcutaneous electrical muscle stimulation stimulates the same receptors in~     the spinal cord dorsal horn as fentanyl, it is hypothesized that it could also improve~     exercise capacity.~      Therefore, the aim of this study is to assess wether transcutaneous electrical stimulation~     (high or low frequency) is effective in improving exercise capacity in patients with severe~     to very severe chronic obstructive pulmonary disease.~   "
19455|NCT03312309|"~     At present, the evaluation criterion of endometrial receptivity is controversial. The~     development of a molecular diagnostic tool, the endometrial receptivity array (ERA) for~     diagnosis of endometrial receptivity . But use of this test in patients with RIF has shown~     that the window of implantation (WOI) is displaced in only a quarter of these patients and~     use of a personalized embryo transfer (pET) on the day designated by ERA improves~     reproductive performance with higher cost .what is known to the others'population? The~     morphological changes observed on histology for each specific day after ovulation were~     described by Noyes and his colleagues in 1950 . An endometrial biopsy that shows a difference~     of more than 2 days between the histologic dating and actual day after ovulation is~     considered to be ''out of phase''. But such pET studies according to the Noyes criterion are~     lacking . The aim of this study is to explore the Personal frozen-thawed embryo transfer in~     unexplained RIF patients according to the blinded histological dating of endometrial biopsies~     .~   "
19456|NCT03312296|"~     Reliable data on stent thrombosis (ST) in comatose out of hospital cardiac arrest (OHCA)~     survivors is lacking. In comatose OHCA survivors suspicion of ST can be made with precise~     clinical monitoring of the patient with definite confirmation being possible only by coronary~     angiography or autopsy of deceased patients. However in addition to definite ST which can be~     confirmed using current protocols, additional ST which are clinically silent are plausible.~     These could be identified only by systematic coronary angiography of all OHCA survivors or by~     autopsy of deceased patients. Collectively with definite ST confirmed by coronary angiography~     upon clinical suspicion the incidence of all forms of ST in survivors of OHCA treated with~     PCI and hypothermia could be obtained.~      Consecutive comatose survivors of OHCA treated with percutaneous coronary intervention (PCI)~     and hypothermia will be included. All study participants will receive treatment per our~     established clinical protocol and will be followed for 10 days. In all patients in whom~     clinical suspicion of ST will be made immediate coronary angiography and if necessary PCI~     will be carried out. In all patients that will die in the observed period of 10 days autopsy~     will be performed. Survivors however will have an additional control coronary angiography on~     10th day after admission, to assess presence of clinically silent ST.~      We expect that the incidence of true definitive ST in comatose OHCA survivors treated with~     urgent PCI with stenting and hypothermia is greater than one, which is confirmed on the basis~     of clinical suspicion by angiography or later with autopsy.~   "
19457|NCT03312283|"~     This is a randomized, double-blind, two-group parallel, positive-controlled clinical Phase I~     trial comparing the safety, pharmacokinetics and pharmacodynamics of QL1205 and Lucentis® in~     patients with wet age-related macular degeneration.~   "
19458|NCT03312270|"~     People with aphasia often understand spoken utterances better than written sentences. They~     also benefit from having content appear in multiple rather than single modalities. Because~     text-to-speech (TTS) systems accommodate both of these functions, it provides an ideal basis~     for a reading intervention. TTS systems convert written text to provide both text and~     auditory information. Research about using TTS supports with people with aphasia has not~     extended beyond basic case studies and our studies of sentence level comprehension. Hence, no~     evidence exists about varying TTS features—such as speech output, speech rate, and text~     highlighting—known to benefit others with reading problems. Also, social acceptance of TTS is~     not well understood, even though it is critical to adoption and long-term use of the~     technology.~      The purpose of this study is to evaluate various aspects of multimodality presentation of~     material through TTS systems used by people with aphasia. The immediate outcome of the~     proposed research will be evidence-based recommendations for selecting and adjusting TTS~     systems and features. This work will enable clinicians to maximize benefits for adults with~     varying aphasia profiles. We also will obtain initial evidence about the social validity and~     perceived value of TTS system use for this population.~   "
19459|NCT03312257|"~     This study will test whether the combined treatment of 0.01% atropine and soft bifocal~     contact lens wear produces slower myopia progression and axial elongation compared to soft~     bifocal contact lenses alone in children ages 7 to 11 years old.~   "
19460|NCT03312244|"~     Human immunodeficiency virus (HIV) infection is a public health problem with enormous~     personal, and social losses. According to the National Mexican HIV/AIDS survey, more than~     235,000 new cases of HIV infection were reported in Mexico between 1983 and 2015.~      HIV infection is characterized by persistent immune activation and constant turnover of T~     cells. This leads to a precipitous fall in the number of CD4 + and CD8 + T cells, as well as~     to an early immunosenescence phenomenon that conditions susceptibility to opportunistic~     infections and a profound decrease in circulating and mucosal T cells. In these patients,~     modulation of the immune response represents a promising mechanism to maintain immunological~     homeostasis and prevent the development of pathology. From this perspective, it is feasible~     that lesser immune activation - rather than accelerating the progression of infection - may~     be an important actor in controlling infection and delaying the progression from chronic~     infection to acquired immunodeficiency syndrome (AIDS) .~      The administration of highly active antiretroviral therapy (ART) has resulted in a reduction~     in the mortality of these patients, although the occurrence of late morbidity due to both~     infection and treatment has increased. Unfortunately, even in cluntries with complete~     coverage for HIV-infection, a large group of patients do not start treatment until late~     stages, in which immunosenescence is profound and the possibilities of immunological recovery~     (increase in T cell counts CD4 +, normalization of the CD4 + / CD8 + index, decrease in~     susceptibility to opportunists, normalization in the cellular response to vaccines) are very~     low. In this context, finding new immuno-modulatory strategies that are both easily~     applicable and potentially improving survival and quality of life is crucial.~      The therapeutic use of neuroimmune regulators in HIV infection has been poorly explored. In~     brief, the nervous system has evolutionary mechanisms of reflex control of the inflammatory~     response, such as cholinergic anti-inflammatory reflex (RCA). Cholinergic stimulation through~     the use of nicotinic agonists has shown promising effects in murine and cellular models of~     systemic inflammation. Since cholinergic agonists are rapidly degraded or cause side effects,~     we performed a pilot study using pyridostigmine (Mestinon®), an acetylcholinesterase~     inhibitor (ACh-E), in HIV-infected patients. We observed that administration of~     pyridostigmine decreases the activation and proliferation of HIV-infected T cells, reduces~     the production of interferon (IFN) -gamma and increases that of interleukin (IL) -10~     (Valdés-Ferrer SI et al., AIDS Research And Human Retrovir 2009). In a second open-label~     pilot study in seven chronically infected patients with full virological suppression but~     without concomitant elevation of CD4+ T cell counts, we found that the addition of~     pyridostigmine to ART led to a sustained and significant increase in the number of CD4 + T~     cells (PRS record: NCT00518154; in preparation for publication). These results suggest that~     the addition of pyridostigmine to antiretroviral therapy may be beneficial in achieving and~     maintaining immunological homeostasis in patients with HIV.~      The present study will address the potential effectiveness of add-on pyridostigmine (90mg,~     once per day, per oris) on CD4+ T cell counts, CD4+/CD8+ ratio, as well as ex-vivo markers of~     T cell phenotype and activity. The study is designed as a 24-week crossover study where~     patients will start a 12-week of pyridostigmine or placebo, and then crossing-over for an~     aditional 12 weeks (placebo-to-pyridostigmine, and pyrodistigmine-to-placebo).~      Since pyridostigmine is a commonly used drug for both myasthenia gravis and as a preventive~     in biological warfare cases, if our hypotheses are correct, the results will be easily~     extended to clinical practice, as there is enough long-term evidence of utility and safety of~     the drug.~   "
19461|NCT03312231|"~     This is a randomized, double-blinded, Phase II study in healthy males and non-pregnant~     females 19 years and older that is designed to assess the safety, reactogenicity, and~     immunogenicity of a pre-pandemic 2017 monovalent inactivated influenza A/H7N9 virus vaccine~     (2017 H7N9 IIV) administered at different dosages given with AS03 adjuvant and phosphate~     buffered saline (PBS) diluent, with AS03 adjuvant only, and without adjuvant. Eligible~     subjects will be randomized into 5 study groups, stratified by age. The study will enroll up~     to 420 individuals 19-64 years old and up to 300 individuals who are 65 years old and older.~     Study duration is approximately 16 months with subject participation duration approximately~     13 months. The primary objectives of this study are: 1) to assess the safety and~     reactogenicity following receipt of two doses of 2017 H7N9 IIV administered intramuscularly~     at different dosages approximately 21 days apart given with or without AS03 adjuvant; 2) to~     assess the serum hemagglutination inhibition (HAI) and neutralizing (Neut) antibody responses~     following receipt of two doses of 2017 H7N9 IIV administered intramuscularly at different~     dosages approximately 21 days apart with or without AS03 adjuvant, stratified by age of~     recipient.~   "
19464|NCT03312192|"~     The purpose of this study is to compare the clinical results between two different techniques~     for ACDF: 1. Stand-alone ACDF, which means the placement of an interbody device (cage)~     without anterior fixation or plating; 2. ACDF with and interbody cage and anterior plating~     for fixation. Both of these procedures are commonly performed at Rush with unclear advantage~     of one procedure over the other. Both have been associated with good to excellent clinical~     outcomes. The devices used in this study are approved by the Food and Drug Administration~     (FDA).~   "
19465|NCT03312179|"~     ST elevation myocardial infarction (STEMI) patients affected by multivessels coronary artery~     stenosis, represent a clinical relevant problem. The management and prognosis of these~     patents are supported by few literature data. Therefore, in this study authors enrolled real~     world diabetic vs. non diabetic patients admitted for STEMI and associated to multi vessels~     coronary disease. Then these diabetics were divided in incretin users (6 months of incretin~     treatment before study enrollment) vs. never incretin users. In these patients authors~     studied all cause mortality, cardiac mortality, and major adverse cardiac events at 12 months~     follow up.~   "
19466|NCT03312166|"~     SCARWARS study deals with the first on-human evaluation of a compressive device dedicated to~     the prevention of keloïd scars recurrence after surgery. The tested device is made with~     clinical grade silicon. SCARWARS is a monocentric study. 27 patients will be include and~     follow during one year. The primary outcome of this study is the number of keloid recurrence~     after treatment.~   "
19467|NCT03312153|"~     The aim of this study is to compare the effect of Neem (azadirachta indica) and 2.5% sodium~     hypochlorite as root canal irrigants on the intensity of post-operative pain and the amount~     of endotoxins in necrotic teeth.~   "
19468|NCT03312140|"~     Pilot study to investigate the effect of choline chloride in cystic fibrosis patients with~     liver steatosis by comparing their status before and after the intervention~   "
19469|NCT03312127|"~     The aim of this project is to demonstrate the benefit of the use of aortic iliac branch~     endoprosthesis in the iliac aneurysms and to avoid the classic complications.~   "
19470|NCT03312114|"~     Programmed death-1 receptor ligand (PD-L1) the ligand for PD-1 is a key therapeutic target in~     the reactivation of the immune response against multiple cancers. Pharmacologic inhibitors of~     PD-1 have also demonstrated significant anti-tumor activity and are currently under active~     clinical exploration. avelumab (MSB0010718C; anti-PD-L1 is a fully human anti-PD-L1 igG1~     antibody that has shown promising efficacy and an acceptable safety profile in multiple tumor~     types.~      Radiation therapy (RT) is one of the mainstream treatments of cancer therapy along with~     surgery and chemotherapy, yet RT is the only treatment that does not leave the patients~     immunocompromised (unlike chemotherapy) and keeps the dying tumor / antigen depot within the~     host (unlike surgery), providing an opportunity for antigen presentation. Therefore, RT is a~     rational choice to combine with immunotherapy for cancer treatment.~   "
19471|NCT03312101|"~     Introduction: The prevalence of biomechanical alterations in the the lower limbs in~     school-age children is increasing. The aim of this study is to assess the effectiveness of a~     therapeutic exercise program in child athletes with lower limb overpronation during gait.~      Methods: Relevant databases (PubMed and SCOPUS) were searched. A total of 123 young athletes~     (aged 9-12 years) will be evaluated. Subjects will be tested biomechanical analysis including~     all relevant angles, as follows: the Helbing angle, the femorotibial angle, and the Fick~     angle in both limbs. Subjects will be divided into two groups at random. Children in~     experimental group will participate in an exercise program for three months. Children in~     control group will not received treatment for three months. After the study, these children~     will receive the same treatment as children in experimental group.~   "
19472|NCT03312088|"~     The objectives of this clinical investigation are to evaluate the safety and performance of~     the Freedom Total Knee® PCK System.~   "
19473|NCT03312075|"~     An increase in the prevalence of infections due to non-tuberculous mycobacteria (NTM) is~     observed in many countries and recent data suggest the circulation of dominant clones with a~     possibility of human-to-human contamination. The hypothesis is made that these infections are~     also increasing in France and that dominant NTM clones are circulating. The last French study~     carried out in 2004 already showed prevalences of up to 10% in certain French regions. It is~     essential to know the prevalence 8 years later, taking advantage of the new recommendations~     for the management of patients and samples, which will homogenize practices on French~     territory.~      No data are currently available in France on the prevalence of positive serological responses~     in cystic fibrosis patients. Serological analyzes of the sera collected during this study~     will enable us to evaluate the performance of serology in mycobacterial culture and to~     identify patients with no positive respiratory specimen in culture but with positive serology~     indicating potential contact with a mycobacterium. The establishment of a serological~     follow-up of these patients will allow to correlate this result with a clinical evolution and~     / or the detection of NTM in subsequent samples. Serology is an innovative aspect of the~     CIMENT study.~   "
19474|NCT03312062|"~     The purpose of this study is to investigate the long-term effects of foam rolling on elbow~     proprioception, strength and functional motor performance with healthy participants . Study~     group will receive foam rolling exercise. Control group will receive no foam rolling~     exercise. Control group will be given a brochure including information about proprioception~     and foam rolling.~   "
19475|NCT03312049|"~     The study focuses on the causal relationship between mycotoxin exposure (particularly~     aflatoxin B1), birth outcomes, and height for age among young children in Nepal. Previous~     studies have shown a strong association of stunting with mycotoxin exposure yet causality has~     not been proven. Thus, this study will provide a better understanding of the association~     between maternal and/or early life mycotoxin exposure (rates in the blood and breast milk)~     and infant and young child growth. This information is essential if we are to more fully~     understand and effectively address the high rates of stunting in Asia.~   "
19476|NCT03312036|"~     CPFA is currently used in the treatment of severe sepsis with the intention of removing the~     proinflammatory mediators from the systemic circulation. Some evidence exists about the~     bilirubin adsorbing ability of the neutral styrenic resin which is part of the extracorporeal~     circuit of CPFA. The aim of this study is to assess efficacy and safety of CPFA in~     extracorporeal detoxification of liver toxins in patients affected by acute or~     acute-on-chronic liver failure.~   "
19477|NCT03312023|"~     The goals of therapy against chronic hepatitis B are to decrease the morbidity and mortality~     related to chronic HBV infection. Currently available antiviral therapy can suppress viral~     replication but only a small proportion attain functional cure, which is defined as HBV~     surface antigen-to-antibody seroconversion. Hepatitis B surface antigen (HBsAg) is a marker~     of persistent hepatitis B infection.~      It has been observed that patients who had both hepatitis B and hepatitis C, and who were~     treated for their hepatitis C with 12 weeks of ledipasvir/sofosbuvir for had a decline in~     HBsAg levels. This study hypothesizes that a similar decrease would be seen in mono-infected~     hepatitis B subjects over the course of 12 weeks treatment with ledipasvir/sofosbuvir.~   "
19478|NCT03312010|"~     Prospective, double blinded, randomized, clinical study investigating the effects of high~     frequency SCS over exiting nerve roots at T9 for the treatment of chronic back or back and~     leg pain.~   "
19479|NCT03311997|"~     The purpose of this study is to provide reliable evidence on how to best treat proximal~     hamstrings avulsions, and our primary aim is to compare the reported outcome of patients~     treated non-operatively with patients treated with suture anchor reattachment of the tendons~     using the Perth Hamstrings Assessment Tool (PHAT) at 24 months.~   "
19480|NCT03311984|"~     Critically ill Patients are at high risk to develop deep venous thrombosis. However, despite~     receiving of a standard dose of Low-molecular-weight Heparin（LMWH）, many patients still~     develop life-threatening embolism. The purpose of this study is to evaluate the anti-Xa~     levels of different dosing regimens of LMWH in critically ill patients in China.~   "
19481|NCT03311971|"~     The trial aims to evaulate the possiblity that use of virtual reality spectacles will affect~     post operative pain in total knee arthroplasty patients. The trial is a single center open~     label design. Patients will be randomized into two arm study comparing the effect of the use~     of virtual reality spectacles on pain levels and analgesic consumption in the perioperative~     period. The controls shall receive standard post operative care. The endpoints are VAS levels~     and analgesic use.~   "
19482|NCT03311958|"~     Patients suffering from diffuse large B-cell lymphoma (DLBCL) who relapse within 12 months of~     chemotherapy usually undergo salvage therapies, followed by autologous transplant with a low~     success rate. These treatments for relapse have significant toxicities and may not be~     tolerated well by the patients. These patients need an effective means of identifying relapse~     at an early time point to be treated effectively. Detection of circulating tumor DNA (ctDNA)~     has been reported to be a sensitive and more specific method to detect relapse at an early~     stage compared to PET/ CT scans. Purpose of this trial is to monitor patients who have~     undergone successful chemotherapy for the presence of ctDNA. Patients who test positive for~     ctDNA would be treated with Nivolumab for a period of 2 years to avoid complete relapse.~   "
19483|NCT03311945|"~     Phase 3b, single arm, single site simplification study of HIV-1 infected patients with~     virological suppression under the combination of Lamivudine (150 mg BID) plus Raltegravir~     (400 mg BID) switching to Lamivudine (300 mg QD) plus Raltegravir (1200 mg QD): Roll-over~     study of the RALAM clinical trial (NCT02284035)~   "
19484|NCT03311932|"~     This is a two-part, single centre, open-label, randomised, single dose, two-period, crossover~     study to evaluate the bioavailability of Infacort® versus Cortef® immediate release~     hydrocortisone tablets in dexamethasone-suppressed healthy adult male and female subjects in~     the fasted and fed states.~      The study will be conducted in two parts (Part 1 and 2) which will not be performed~     sequentially. In Part 1, 24 subjects will be dosed in a fasted condition and in Part 2, 24~     subjects will be dosed in a fed condition. Each part will comprise of a pre-study screen,~     followed by 2 treatment periods (1 and 2) and a post-study follow-up.~   "
19485|NCT03311919|"~     The aim of this study is to describe the frequency of the presence of cells Natural Killer~     (NK) expressing CD86 and HLA - DR in tonsils~   "
19486|NCT03311906|"~     assess the clinical and laboratory effects of the local and sub gingival application of a~     0.8% hyaluronic acid gel (GENGIGEL®) as an adjunct to scaling and root planning (SRP) in~     chronic moderate to severe periodontitis patients as indicated by expression of Human Beta~     Definsin-2 (HBD2) in gingival crevicular fluid (GCF).~   "
19487|NCT03311893|"~     200 participants' perception and acceptability of natural hole surgeon~   "
19488|NCT03311880|"~     The goal in this study is to evaluate the effectiveness of a cognitive remediation program~     that was designed specifically to address the concerns related to cognitive difficulties that~     are often reported among women in the menopausal transition. This cognitive remediation~     program has been created to provide our clients with an opportunity to learn more about the~     relation between menopause and cognitive function, to learn new strategies to enhance~     thinking skills (e.g., memory, attention) and to hear about lifestyle changes that are known~     to have a beneficial effect on mental functioning.~   "
19489|NCT03311867|"~     The purpose of the proposed study is to examine the relationship between cerclage suture~     material of Ethibond and Prolene and its effect on the vaginal microbiome in a prospective~     randomized control trial. Ethibond is another commonly used suture material for performing~     cervical cerclage that shares some characteristics with previously studied suture materials.~     It is braided like the Mersilene, but thinner like the monofilament Prolene. The~     investigators will study whether Ethibond causes the vaginal microbiome to be adversely~     affected like Mersilene or whether there is a healthy microbiome like Prolene. This study~     will allow the investigators to determine whether it is advisable to continue to use Ethibond~     for cervical cerclage in clinical practice, or whether obstetricians should avoid its use as~     now done with Mersilene.~   "
19490|NCT03311854|"~     Macrophage Activation Syndrome (MAS) is a rare, life-threatening condition characterized by~     uncontrolled hyperinflammation which may develop on the background of systemic Juvenile~     Idiopathic Arthritis (sJIA). NI-0501 (Emapalumab) is a monoclonal antibody neutralizing~     interferon-gamma (IFN-gamma), a key cytokine which contributes to the inflammation and tissue~     damage seen in MAS. The purpose of this study is to assess the safety, tolerability and~     efficacy of NI-0501 in sJIA patients developing MAS, presenting an inadequate response to~     high dose glucocorticoid treatment.~   "
19537|NCT03311243|"~     The study aims to evaluate the effect of local non surgical periodontal therapy on the~     systemic pro-inflammatory markers in the β-thalassemia (TM-β) patients with chronic~     periodontitis and systemically healthy demographically matched controls with chronic~     periodontitis. Both groups will receive non surgical periodontal therapy.~   "
19491|NCT03311841|"~     The purpose of this study is to characterize the plasma pharmacokinetic profiles of~     midazolam, dabigatran, pitavastatin, atorvastatin, and rosuvastatin following a single oral~     dose administration of a microdose cocktail in healthy participants, in participants with~     mild, moderate, severe (not on dialysis) renal impairment, and in participants with end-stage~     renal disease (ESRD; on dialysis).~   "
19492|NCT03311828|"~     This pilot phase I clinical trial studies how well copper 64Cu-DOTA-daratumumab positron~     emission tomography works in diagnosing patients with multiple myeloma that has come back.~     Diagnostic procedures, such as copper 64Cu-DOTA-daratumumab positron emission tomography, may~     help evaluate the extent of multiple myeloma in patients prior to the initiation of treatment~     and ultimately monitor disease status/response during and post treatment.~   "
19493|NCT03311815|"~     NGS studies will be done in stem cell leukemic population. The analysis of the samples to the~     diagnosis will be carried out using the 26 consensus genes: ASXL1 had, CBL, CEBPA, DNMT3A,~     EZH2, FLT3, GATA2, IDH1, IDH2, JAK2, KIT, KRAS, MPL, MLL, NPM1, NRAS, PTPN11, RUNX1, SETBP1,~     SF3B1, SRSF2, TET2, TP53, U2AF1, WT1. Regarding the 26 genes panel, it would have the~     advantage that the quantification of DNA from each sample will be carried out by fluorimetry~     using the AmpliSeq or TruSeq on Ion platforms torrent Proton or MySeq are handled in~     different laboratories.~      Using NGS techniques the investigator will detect the recurrently mutated genes in AML to~     establish the biological role of each mutation.~      The molecular characterization of the 700 samples which are estimated to pick up during the~     project will consist of massive sequencing of genes recurrently mutated in AML (ASXL1, had,~     CBL, CEBPA, DNMT3A, EZH2, FLT3, GATA2, IDH1, IDH2, JAK2, KIT, KRAS, MPL, MLL, NPM1, NRAS,~     PTPN11, RUNX1, SETBP1, SF3B1, SRSF2, TET2, TP53, U2AF1, WT1). Found mutations will be~     collated in the different databases of somatic variations to establish which of them could be~     classified as a driver or passenger.~   "
19494|NCT03311802|"~     This was a cross-sectional investigation conducted from December 2015 to July 2017, in 15~     selected rural villages of 2 districts of Vientiane municipality, Lao PDR. Target population~     was interested people, both men and women of age range between 30 to 70 years, living in the~     selected community. Someone diagnosed with diabetes and/or using any anti-diabetic drug was~     excluded.~      The study protocol initiated with the interview on demographic and behavior information with~     each participant, followed by physical exam and blood pressure measurement.~      Fasting glucose were measured.~   "
19495|NCT03311789|"~     This is a single-arm, phase I/II trial in biliary tract cancer (BTC) patients. The purpose of~     this trial is to evaluate the safety and effect of PD-1 inhibitor in combination with~     gemcitabine/cisplatin chemotherapy in patients with advanced unresectable or metastatic BTCs.~      The primary objective: 6-month progression free survival (PFS). The second objectives:~     objective clinical response(according to RECIST version 1.1), safety, symptom control and~     quality of life (QoL) (according to EORTC QoL C30 and BIL 21), overall survival. The~     exploratory objectives: assessment of immunological response (cytokines, lymphocyte~     phenotype, immunoglobulins), and evaluation of pathological, immunological and clinical~     predictive factors for response/toxicity.~   "
19496|NCT03311776|"~     No validated biomarkers to identify PC at an early stage and to predict treatment outcomes in~     the individual patient exist. The objective of the present study is to find diagnostic,~     prognostic and predictive biomarkers.~   "
19497|NCT03311763|"~     The investigators plan to integrate and tailor the existing Exercise is Medicine framework,~     an evidence-based multi-level intervention program developed by the American Society of~     Sports Medicine, for the care of patients with advanced chronic kidney disease. In this pilot~     randomized control trial, investigators will compare the effects and feasibility of two~     intervention arms designed to start and maintain physical activity in this high-risk~     population (Group 1: physical activity assessment, brief counseling session + physical~     activity wearable versus Group 2: Group 1 intervention components + referral to a free,~     community-based, EIM practitioner led group exercise program).~   "
19498|NCT03311750|"~     A-REPEAT (Anti-Epidermal Growth Factor Receptor -EGFR- rechallenge and plasma genotyping of~     patients with advanced colorectal tumors) is a Greek, investigator-initiated, single arm~     open-label phase II study of anti-EGFR therapy rechallenge in combination with chemotherapy~     in patients with advanced colorectal cancer. Patients with a metastatic, histologically~     proven colorectal carcinoma RAS wild type will be treated with a combination of panitumumab~     and third-line irinotecan-based or oxaliplatin-based chemotherapy (FOLFOX,FOLFIRI or~     irinotecan monotherapy).~   "
19499|NCT03311737|"~     This is a single center, randomized, single blind study to compare the analgesic effect of~     different anesthesia and postoperative analgesic methods in uniportal VATS lung surgery.~   "
19500|NCT03311724|"~     The purpose of this study is to determine the efficacy of LY3298176 in participants with type~     2 diabetes.~   "
19501|NCT03311711|"~     The proposed study will adapt and pilot test an efficacious advance care planning~     interventions, SPIRIT (Sharing Patient's Illness Representations to Increase Trust), with~     patients with mild Alzheimer's Disease (AD) and their surrogates to promote open, honest~     discussions while such discussions about end-of-life care are possible.~      The study includes two phases: Phase I to adapt, pretest, and refine SPIRIT, and Phase II to~     pilot test the refined SPIRIT to formally evaluate its feasibility, acceptability, and~     preliminary efficacy. The final products will be the modified SPIRIT intervention that~     improves AD patient and surrogate outcomes, and standardized intervention manuals, including~     the SPIRIT Interview Guide, fidelity assessment, and training materials.~      Patient and surrogate decision maker dyads will participate in a single SPIRIT session and~     will then have a follow up phone call 2-3 days later. One year after the SPIRIT session some~     surrogates will be contacted to provide additional feedback about the intervention.~   "
19502|NCT03311698|"~     HANU is an evaluation of the effects of an integrated, gender-focused nutrition-sensitive~     intervention on the nutrition and health of young children and women of reproductive age in~     rural Tanzania.~   "
19503|NCT03311685|"~     Female patients with POP will be evaluated for vaginal elasticity using vaginal tactile~     imaging both before and after surgery for the repair of the POP. Surgical repair will be~     performed by a single surgeon who will perform either a laparoscopic or vaginal repair.~   "
19538|NCT03311230|"~     This study tests the effectiveness of three social incentive-based gamification interventions~     to increase physical activity using a 24-week intervention period with a 12-week follow-up.~   "
19504|NCT03311672|"~     This is a single-center cross-sectional imaging study in patients with localized lung cancer~     undergoing immunotherapy with or without stereotactic radiation therapy as part of the~     companion clinical trial (NCT03217071; Pembrolizumab With and Without Radiotherapy for~     Non-Small Cell Lung Cancer). Each patient will undergo a single [18F]F-AraG PET exam as part~     of this study. [18F]F-AraG will be administered at a single time point intravenously prior to~     PET imaging. Whole-body PET will be acquired along with a whole body low dose CT (PET/CT)~     used for attenuation correction and anatomic localization of [18F]F-AraG uptake, SUV~     calculation, and volumetric selection for radiomic analyses.~   "
19505|NCT03311659|"~     Diphtheria, tetanus and pertussis are common causes of diseases worldwide, with significant~     morbidity and mortality. The purpose of this study is to assess the immunogenicity, safety~     and reactogenicity of a single dose of GlaxoSmithKline (GSK) Biologicals' Boostrix vaccine,~     administered as a booster dose in healthy Russian subjects. An equal number of subjects are~     expected to be recruited in the following age categories: 4-9 years (children), 10-17 years~     (adolescents), 18-64 years (adults) and ≥65 years (elderly population). By receiving the~     Boostrix vaccine, the subjects could be protected against diphtheria, tetanus and pertussis~     diseases.~   "
19506|NCT03311646|"~     Smoking is the leading cause of preventable death in the United States. An FDA-mandated~     reduction in the nicotine content of cigarettes might reduce the health burden of tobacco by~     reducing the prevalence of smoking. The proposed project will test the impact of nicotine~     reduction on smoking behavior and smoke exposure in a setting where participants are~     restricted from using their usual brand cigarettes.~   "
19507|NCT03311633|"~     BACKGROUND. Distal radius fractures (FRD) are up to 17% of all diagnosed fractures and are~     the most commonly treated fractures in adult orthopedic patients. The management could be~     either conservative or surgical, depending on AO bone fracture classification. The principles~     of good treatment involves an anatomical reduction with a proper immobilization that keep the~     reduction.~      OBJECTIVE. Determine if percutaneous pinning for six weeks versus three has major~     complications in distal radius fractures.~   "
19508|NCT03311620|"~     Needle biopsy samples are routinely collected to evaluate cytomorphology, immunohistochemical~     markers and for mutational analysis. With regular use of immunotheraputic interventions,~     needle biospy has become more frequent and requires bigger samples for an increasing battery~     of tests. There has been no clear consensus on which biopsy needle yields the best biopsy~     sample. It is unclear if large 19g needle offers better yield than a 22 g needle. Although~     previous studies comparing 21, 22 and 19g needles have suggested that larger needles yield~     larger biopsy sizes, conflictng studies have shown that larger biopsies lead to bloodier~     samples with potentially smaller fragments of tissue, offering no improvement in diagnostic,~     yield, adequacy or sample size.~      This study compares biopsy samples collected using 19g and 22g needles from patients of non~     small cell lung cancer (NSCLC) scheduled to undergo endobronchial ultrasound (EBUS) and~     transbroncial needle aspiration (TBNA).~   "
19509|NCT03311607|"~     The safety and effectiveness of AmBisome 15 mg/kg, given over 15 days in 5 biweekly infusions~     of 3 mg/kg on an outpatient basis, is evaluated in clinically diagnosed PKDL patients of 12~     years and older in a highly endemic area in Bangladesh. This is a prospective study, with the~     objective to assess final cure 12 months after treatment.~   "
19510|NCT03311594|"~     The societal impact of heavy alcohol consumption and chronic pain is substantial and warrants~     the existing research investment into their etiology and treatment. Moreover, evidence of~     significant co-occurrence between these conditions offers an opportunity to examine~     mechanisms in the alcohol-pain connection that may inform the development of novel~     treatments. Consistent with NIH PA-15-026 (Mechanistic Studies of Pain and Alcohol~     Dependence), the goal of the proposed study is to examine several complex and potentially~     bidirectional relations between pain and alcohol in one overarching model, which has never~     been attempted in a human experimental paradigm. The primary study aims are as follows: (1)~     to conduct the first test of both pharmacological and expectancy effects in acute alcohol~     analgesia among humans; (2) to conduct the first test of pain as a proximal antecedent of~     urge to drink and ad lib alcohol consumption, and to test whether acute analgesic effects~     predict pain-induced alcohol urge/consumption; (3) to test associations between study~     outcomes and candidate genetic polymorphisms that have been implicated in pain-alcohol~     processes; and (4) to conduct exploratory analyses of gender and pain relevant~     cognitive-affective factors as moderators of these outcomes. Participants will include 280~     moderate-to-heavy drinkers recruited from the local community. Experimental methods will~     include alcohol administration (moderate dose vs. low dose vs. placebo vs. control) and~     pre/post assessment of static/dynamic pain responses, and capsaicin/heat pain induction (vs.~     no pain induction) followed by assessment of urge to drink and ad lib alcohol consumption. By~     employing a novel experimental paradigm, the study results will provide internally valid data~     with clear and direct implications for translating these findings to clinical applications.~     It is our expectation that this work will catalyze future research and inform clinical~     practice by establishing an experimental platform that allows for the demonstration of causal~     effects, the evaluation of treatment components prior to conducting costly clinical trials,~     and the identification of important theory-based biopsychosocial mechanisms that can inform~     the development of novel integrated treatments for individuals with co-occurring pain and~     alcohol use disorders.~   "
19511|NCT03311581|"~     Written informed consent must be obtained before any study specific procedures are~     undertaken. Informed consent will be obtained during pre-operative assessment.~   "
19512|NCT03311568|"~     Aim of this study is (1) to test and further develop a new non-invasive ultrasound method,~     and (2) to gain new insight into microcirculatory alterations during critical disease,~     particularly in critical septic shock patients.~      Although early identification and treatment of sepsis have had top priority among the working~     tasks of the international 'Surviving Sepsis Campaign' society (collaboration of the Society~     of Critical Care Medicine and the European Society of Intensive Care Medicine) for several~     years, which have led to improved survival over the last two decades, there is no objective~     validated diagnostic test to identify or to support the clinical diagnosis at an early stage.~     Analogous, there is no validated monitoring system available to guide and evaluate the~     effects of stabilizing measurements in sepsis, or other critical disease, at the~     microcirculatory level. And thus, there is an enormous knowledge gap regarding dynamic~     changes at the microcirculatory level during sepsis and other critical disease.~      Goal with this study is to investigate the robustness of this new US-technology, regarding~     its ability to identify and monitor critical microcirculatory impairment during critical~     disease. The investigators believe this technology may improve early diagnosis and thus early~     initiation of adequate treatment in septic shock. Its mobile and non-invasive qualities, as~     in most ultrasound methods, substantiate its availability to a wide range of clinical~     settings.~   "
19539|NCT03311217|"~     The THRIVE study is a healthy retail intervention that improves the food environments in~     tribally owned and operated convenience stores in the Chickasaw Nation and Choctaw Nation of~     Oklahoma.~   "
19513|NCT03311555|"~     The purpose of this study is to describe the rate of 3-year progression free survival in men~     with recurrent PSA-only disease after prostatectomy, who receive combined apalutamide~     (ARN-509) and standard ADT with salvage radiation therapy followed by docetaxel, ADT, and~     apalutamide, AND who have had testosterone recovery to >100 ng/dl at 36 months. The~     hypothesis is that AR inhibition with apalutamide added to standard salvage external beam~     radiation with androgen deprivation therapy, as well as the addition of 6 cycles of~     docetaxel, will further prolong progression free survival.~   "
19514|NCT03311542|"~     This is an expanded access program (EAP) for patient with Melanoma and Glioblastoma who have~     progressed after prior Protocol therapy including Bevacizumab, Temozolomide ( TMZ ),~     Ipilimumab, BRAF and MEK inhibitors. The patients whose tumors are EGFR, MET or ALK positive~     should first receive an EFGR or ALK inhibitor, respectively, prior to treatment with~     pembrolizumab.~   "
19515|NCT03311529|"~     As mental disorders constitute a core health care challenge of the 21th century, increased~     research efforts on preventive interventions are indispensable. In the field of clinical~     psychology, indicated preventive interventions targeted to those with initial symptomatology~     appear particularly promising. Applied relaxation (AR) is a well-established intervention~     technique proven to effectively reduce tension/distress, anxiety and depressive symptoms in~     the context of treatment of a wide variety of manifest mental disorders as well as somatic~     illnesses. However, it has not been studied so far whether AR as indicated preventive~     intervention in subjects with initial symptomatology but no full-threshold mental disorder~     yet is capable to prevent a further symptom escalation. This randomized controlled trial in~     subjects with elevated tension/distress, anxiety or depressive symptomatology aims to~     investigate whether an AR intervention (10 sessions à 60 min) can (a) effectively reduce~     present psychopathological symptoms as well as (b) prevent a further symptom progression to~     full-threshold DSM-5 mental disorders. Putative mediators (physiological, emotional,~     cognitive and behavioral changes including heart rate and heart rate variability, hair and~     salivary cortisol secretion, affectivity, self-efficacy, internal locus of control and~     cognitive / behavioral coping) and moderators (sex, age, symptom severity at baseline and~     homework adherence during the intervention course) of the intervention/preventive efficacy~     will be additionally studied. Predictor and outcome measures will be assessed both~     conventionally (via personal interview, questionnaires and physiological measures during the~     respective main assessment) and with ecological momentary assessments (EMA, applied via smart~     phone over a 1-week interval following the respective main assessment) in everyday life.~   "
19516|NCT03311516|"~     The aim of the study is to evaluate the effect of insulin therapy when the bolus dose of~     insulin is calculated on the basis of protein and fat content in food intake, in addition to~     that of carbohydrates in T1D patients treated by insulin pump. The study is planned to~     recruit 150 patients with type1 diabetes already practicing functional insulin therapy based~     on carbohydrate counting in meals. We will therefore study the effect on continuous glucose~     measured by subcutaneous sensor, of meal bolus adjustments by comparing two groups of T1D~     patients:~        -  Groupe A takes into account the lipid and protein content in addition to the~          carbohydrate content~        -  Group B takes into account the carbohydrate content only At randomization, all patients~          receive dietary and adjustment of bolus doses instructions according to the~          randomization group. They have to apply these instructions for 3 months. At the end of 3~          months, the study groups will be under glucose monitoring during two weeks in the~          Outpatient Clinic but returns to the investigational site in hospital to download data~          from the continuous measurement of glucose. In addition, we propose a period of~          extension similar to that of the main period, namely 3 months of application of dietetic~          and adaptation of bolus doses instructions and 2 weeks of continuous measurement of~          glucose.~      During each 2 weeks period will be assessed specific glucose parameters in the post-prandial~     period over 4hours (glycemic sensor values in the glucose range between 70-140 mg / dl,~     glycemic sensor values in the glucose range between 140 -180 mg /dl and > 180 mg /dl) after~     taking each meal during each Glucose Continuous Measurement week, average daily glucose per~     meal, average blood glucose over the 2 week period after each meal~   "
19517|NCT03311503|"~     This is a phase I/II open label multi-center study in which patients will receive low dose~     targeted busulfan followed by infusion of autologous CD34+ selected bone marrow or mobilized~     peripheral blood cells transduced with the G2SCID vector. Subjects will be enrolled over 3~     years and be followed for 2 years post-infusion on this protocol, then followed long-term on~     a separate long-term follow-up protocol.~      Enrollment of subjects will be agreed upon by representatives of both sites. Data will be~     collected uniformly from both sites through an electronic capture system and key laboratory~     studies will be centralized.~      Harvest, cellular manufacturing and infusion will occur at each site using the same SOPs. Key~     aspects of cellular product characterization will be centralized~   "
19518|NCT03311490|"~     This pilot study will establish the preliminary effect and safety of using Spraino® to~     prevent lateral ankle sprains amongst athletes competing in indoor sports at sub-elite level,~     with a one-year follow-up.~      All recruited participants will have a history of lateral ankle sprain in the preceding 24~     months prior to the initiation of the trial. Half of the included participants will receive~     Spraino® to prevent lateral ankle sprains (intervention group). The other half will receive~     no intervention (do-as-usual control group). Both groups will be permitted to continue or~     initiate any usual care of their choice, except Spraino® in the control group. Short Message~     Services (SMS) will be used for registration of injury and exposure.~   "
19519|NCT03311477|"~     An open-label, dose-escalation study designed to evaluate the safety, pharmacokinetics, and~     preliminary efficacy of ABBV-399 in participants with advanced solid tumors.~   "
19520|NCT03311464|"~     This study is designed to investigate the efficacy, safety and pharmacokinetics of adalimumab~     in subjects in Japan with active ulcer(s) due to Pyoderma Gangrenosum (PG).~   "
19521|NCT03311451|"~     The primary objective is to determine the safety, performance and efficacy of the C2~     CryoBalloon 180 Ablation System (CryoBalloon 180) used at increasing doses in treatment~     naïve patients with low- or high-grade dysplastic Barrett's Esophagus (BE) or with residual~     BE after resection of dysplasia or early adenocarcinoma.~   "
19548|NCT03311100|"~     It has become clear in the recent year that the nature of the immune cells infiltrate within~     a tumor was essential in the control of the tumor growth. This so-called immune contexture~     does vary between cancer types and in response to treatments. In this context, this trial is~     a non-interventional, mono-centric in patients with solid tumors. Samples in~     paraffin-embedded material block of biopsies or surgical pieces (either primitive tumor or~     metastases) will be analysed. For each sample, clinically relevant data associated with~     treated cancer and needed for characterization of tumor microenvironment will be documented.~      This trial is, through accessing to well documented selected archival tumor materials, to~     validate selected biomarker for early phase trial.~   "
19522|NCT03311438|"~     Background: Children with congenital heart defects (CHD) are reported to have poorer oral~     health compared with healthy children. The aim of the present study was to evaluate the~     effect of an intensive oral health care program among children with CHD followed from infancy~     to the age of five years, by comparing their oral health status at five years with a control~     group of children with CHD who had not received the program.~      Methods: In this longitudinal study, children in western Norway with a need for lifelong~     follow-up due to congenital heart defects were invited to participate (n=119). Children born~     in 2008-2011 were offered a promotive oral health intervention program from infancy to the~     age of five years. The outcome measures for evaluating the intervention were dental caries~     prevalence, dental erosion, plaque index and gingival bleeding index. The data of the~     intervention group were compared with cross sectional oral health data of five year old~     controls with CHD born 2005-2007 (already published).~   "
19523|NCT03311425|"~     The purpose of this study is to determine if the incidence and duration of postoperative~     dysphagia are improved in the participants receiving a local injection of methylprednisolone~     with systemic dexamethasone when compared to those receiving the usual systemic~     dexamethasone.~   "
19524|NCT03311412|"~     This is the first study to test Sym021 in humans. The primary purpose of this study is to see~     if Sym021 is safe and tolerable for patients with locally advanced/unresectable or metastatic~     solid tumor malignancies or lymphomas that are refractory to available therapy or for which~     no standard therapy is available.~   "
19525|NCT03311399|"~     The present study aims to examine whether or not the use of mobile Health (mHealth) by~     community health workers (CHWs) can improve the identification of surgical site infection~     (SSI) and a timely return to care among patients who undergo cesarean-section surgery at a~     rural hospital in Rwanda.~   "
19526|NCT03311386|"~     Assessment of the evolution of intracranial collaterals and its relationship with functional~     outcomes in acute ischemic stroke (AIS) patients treated with IV tissue plasminogen activator~     (tPA).~   "
19527|NCT03311373|"~     Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to~     Assess the Relative Bioavailability of PT010~   "
19528|NCT03311360|"~     There are two arms in our trial, DCB group, BMS group.The investigators are going to~     investigate the safety and efficacy of all groups at 6 months and 12 months.~   "
19529|NCT03311347|"~     The primary aim of this project is to get further knowledge of the physiology of flight~     atelectasis and its prevention. We seek to: 1) assess whether low levels of positive pressure~     breathing can prevent atelectasis formation in humans during exposure to hyperoxia and~     +Gz-accelerations. 2) get further knowledge on the effects of hypobaria on regional~     ventilation and perfusion.~      A secondary aim is to evaluate the effect of anti G-trouser inflation on ventilation and~     regional perfusion.~   "
19530|NCT03311334|"~     This is a Phase 1, open label, multi-center study of DSP-7888 Dosing Emulsion, administered~     intradermally in combination with checkpoint inhibitors (Nivolumab or Atezolizumab) in adult~     subjects with solid tumors, including advanced melanoma, non-small cell lung cancer (NSCLC),~     head and neck squamous cell carcinoma (HNSCC), renal cell carcinoma (RCC), and urothelial~     cancer that consists of two parts: dose search (Part 1) and expansion (Part 2).~   "
19531|NCT03311321|"~     The life span of adults with end-stage renal disease is reduced, and cardiovascular disease~     (CVD) accounts for approximately half the deaths among those undergoing hemodialysis (HD).~     Vascular calcification is a key process in the development of atherosclerotic and~     arteriosclerotic CVD, and contributes significantly to the greater mortality rates and CVD~     events in HD patients. Recently, there has been growing interest in the vitamin K-dependent~     matrix Gla protein (MGP) and its role in inhibiting vascular calcification. Animal studies~     have revealed that the vitamin K-dependent protein MGP may reduce the progression of vascular~     calcification, possibly by means of improving vascular function. The relationship between MGP~     and vitamin K lies in the fact that inactive matrix Gla protein requires vitamin K to~     carboxylate it for its activation. Currently, data in HD patients are scant and equivocal on~     the effects of vitamin K supplementation on CVD risk outcomes. Therefore, the purpose of this~     8-week randomized, placebo-controlled, double-blind clinical trial is to determine whether~     daily vitamin K supplementation can favorably alter measurements of endothelial function and~     arterial stiffness in HD patients.~   "
19532|NCT03311308|"~     The purpose of this study is to evaluate the effectiveness and safety of the combination of~     Pembrolizumab (KEYTRUDA®) and the investigational drug, Metformin.~   "
19533|NCT03311295|"~     The objective of the study is to evaluate the safety and feasibility of the ARTO System in~     patients with mitral valve regurgitation (MR) associated with congestive heart failure (CHF).~   "
19534|NCT03311282|"~     Breastfeeding is recommended as the ideal form of nutrition for newborns and infants at least~     for the first 6 months of life by several Institutions such as the American Academy of~     Pediatrics (AAP) and the World Health Organization (WHO).~      When breastfeeding is not possible or not desirable, bottle-feeding, in most cases using a~     proper infant formula, is the right alternative.~      Both facial and cranial growth and development rely on genetic and external stimuli; the~     latter are provided also by activities of sucking, swallowing and chewing. Considering this,~     it is important to show the differences between the activities of the muscles (masseter,~     temporalis and buccinator) in charge of sucking during breastfeeding or bottle-feeding.~      The activities of the muscles were evaluated through SLI, which consists of the assessment of~     muscle functioning by analyzing the displacement of a defined point on a given muscle. This~     displacement is tracked over time with respect to a fixed frame of reference, thus providing~     velocity data (i.e. speed) for a certain point on the muscle during muscle contraction. The~     use of SLI allowed us to determine the activity of oral muscles on the different types of~     feeding and to compare their strength and activity.~      Principal aims of the present study was to assess the activity of the orbicularis oris muscle~     (OM) and of the masseter, temporalis and buccinator muscles (MM, TM and BM) (i.e. the muscles~     in charge of sucking during breastfeeding) during breastfeeding and bottle-feeding by means~     of SLI. The new Chicco feeding bottles Natural Feeling (Natural Fit) 0m+, 4m+ and 6m+ were~     used according to the age of the infants.~      Moreover, the following parameters were evaluated comparing breastfeeding and bottle-feeding:~     feeding efficiency (measured as ml/minute milk intake considering an interval of 15 minutes)~     and oxygen saturation during feeding (assessed by pulse oximetry). Moreover colic-like~     symptoms over 9 weeks (0 to 4 weeks infant only) were evaluated through the Infant Colic~     Scale.~   "
19535|NCT03311269|"~     VICARES is a prospective randomized, controlled, multi-center, double blind study treating~     venous insufficiency associated with incompetent saphenous veins with 1% and 3% Sodium~     Tetradecyl Sulfate (STS) solution utilizing the ClariVein system.~   "
19536|NCT03311256|"~     Determination of Tissue Transit Time (TTT) as a parameter with high prognostic value to~     predict the functional course of the differential renal function and the development of the~     differential renal function after pyeloplasty~   "
19540|NCT03311204|"~     In this study, clinical variables related to eyelids that potentially have an effect on~     contact lens discomfort will be investigated such as eyelid signs and secretions, eyelid~     sensitivity, eyelid microbiome, Demodex infestation and tear film properties. The main aim of~     this study is to understand the duration of efficacy of debridement of the eyelid margin and~     its impact on various eyelid signs (such as lid wiper epitheliopathy, lid-parallel~     conjunctival folds, eyelid sensitivity, meibomian gland morphology and meibum secretions,~     palpebral conjunctival reaction, eyelid microbiome and Demodex infestation, tear properties~     (both biophysical properties such as tear volume, tear meniscus height, tear evaporation,~     tear osmolarity and tear breakup time; and biochemical properties that are tear lipid~     analysis). To observe these variables, this study employs a cross-sectional design to study~     the effect of treatment at three instances, that is at baseline and two follow-up visits.~   "
19541|NCT03311191|"~     This research study aims to determine if there are differences in oxygen consumption between~     chronically sun exposed and less sun exposed skin. This study uses a new imaging device that~     can detection oxygenation properties skin in a non-invasive manner.~   "
19542|NCT03311178|"~     Haemodynamic insufficiency after birth is seen commonly in babies born prematurely and is~     associated with adverse outcomes. In current clinical practice, a combination of blood~     pressure and clinical signs is used to guide therapy. However, blood pressure is a poor~     surrogate of systemic and organ (brain) blood flow distribution during transitional~     circulation. This state is characterised by increased peripheral vascular resistance and~     increased afterload causing myocardial depression and impaired blood flow distribution in~     spite of 'normal' blood pressure. Echocardiography-Doppler (Echo-D) measurement of superior~     vena cava (SVC) flow has been proposed as a more clinically relevant marker of circulatory~     impairment shortly after birth than systemic hypotension. When there is low SVC flow, several~     small-scale clinical trials have suggested dobutamine as the optimal therapeutic option.~     However the associations between SVC flow and short- and long- term outcomes are not strong~     enough to allow SVC flow alone to be the basis for the inclusion of patients into a~     confirmatory trial to demonstrate the efficacy and safety of dobutamine.~      NeoCirc-001 - The primary objective is to answer some important questions required for the~     design of a subsequent placebo-controlled trial (NeoCirc-003), which will evaluate the~     effectiveness of a new neonatal formulation of dobutamine to treat haemodynamic insufficiency~     in the first 72 hours after birth in babies born at less than 33 weeks' gestation.~     Observational data will be collected from this population with a view to determining the~     degree to which diagnostic measures influence treatment decisions. The primary outcome is~     death or worst cranial ultrasound (CUS) appearance at or before 36 weeks' gestation.~      NeoCirc-001A - The primary objective is to estimate the elimination half-life, and~     consequently the time to steady-state of dobutamine in extremely premature neonates.~      NeoCirc-001B - The primary objective is to construct a population pharmacokinetic~     pharmacodynamic model that will be validated using samples collected during the confirmatory~     trial (NeoCirc-003).~   "
19543|NCT03311165|"~     Neonatal acute respiratory distress syndrome(ARDS) is a rare but often severe respiratory~     disorder. The incidence remains unclear and mortality is about 30%-60%. It is characterized~     by acute, refractory hypoxemia, persistent respiratory distress and decreased lung~     compliance. Evaluation and comparison of various clinical studies conducted were hindered by~     a lack of uniformity in diagnostic criteria.~   "
19544|NCT03311152|"~     Prospective evaluation of the circulating cell-free DNA-based epigenetic biomarker (mSEPT9)~     through a cross-sectional biomarker phase II design. The aim of the SEPT9-CROSS study is to~     assess the diagnostic accuracy of the plasma mSEPT9 biomarker in a large-scale study of 440~     cirrhotic patients recruited in the Nancy University Hospital.~   "
19545|NCT03311139|"~     Many people who suffer from irregular heartbeats (atrial fibrillation) which might cause~     stroke, need to take blood thinners to prevent it. However, people with atrial fibrillation~     are also at increased risk of acute myocardial infarction or unstable angina pectoris~     (another heart condition marked by a chest pain, comprising so-called acute coronary syndrome~     for which another type of treatment that prevents blood from clotting (antiplatelet~     treatment) is indicated. In particularly if such patients undergo percutaneous coronary~     intervention, a procedure aimed to open up diseased blood vessels and hence to treat acute~     coronary syndrome, this treatment is needed. If a patients takes several anti-clotting blood~     drugs, the risk of bleeding is high. The number of possible drug combinations and treatment~     durations is large. This study will help us to understand which anti-clotting drug~     combinations are prescribed in real life among patients with atrial fibrillation and acute~     coronary syndrome, how effective and safe they are for patients. The study will look into the~     data that are already available in several very large Swedish databases which contain~     information needed for the research.~   "
19546|NCT03311126|"~     This is a phase II single-arm, open-label, multicenter study evaluating the efficacy and~     safety of the combination of induction chemoimmunotherapy with bendamustine and obinutuzumab~     (BO) followed by consolidation therapy and maintenance therapy with obinutuzumab in subjects~     who have not received prior cytotoxic chemotherapy for their MCL (i.e., prior single agent~     rituximab is permitted, prior involved-field radiotherapy is permitted).~   "
19547|NCT03311113|"~     Bone and joint infection (BJI) are bacterial infections that can occur after surgery~     (nosocomial infections) or de novo. They constitute a public health problem in Western~     Countries . These infections are often difficult to treat, with a high rate of~     re-hospitalizations (19.5%) caused by relapses or recurrences. The treatment of Bone and~     joint infection can be surgical and / or pharmacological . Drug treatment is based on the use~     of parenteral and / or oral antibiotics. It is a curative therapy in most cases, with a~     prolonged duration ranging from 6 weeks to several months depending on the lesions .~      Medication adherence, is a patients' behavior defined as drug intake with optimal attendance~     and regularity, as prescribed and explained by the physician. It is a key factor in the~     success of any drug therapy, as drugs don't work in patients who don't take them..~      To the knowledge of investigators, there are no published data on the adherence to antibiotic~     therapy in patients treated for Bone and joint infection. In addition to its prolonged~     duration, the antibiotic treatment of the Osteoarticular Infections may require several daily~     drug intakes and may be responsible for severe adverse effects, these three factors being~     known to adversely affect adherence.~      Prevalence, adherence patterns over time and determinants of adherence in this patient~     population are not known. Currently, drug adherence is not routinely evaluated and is not~     considered in the treatment of Bone and joint infection in the Regional Center for Complex~     Bone and joint infection of the investigators.~      A specific study evaluating adherence to antibiotic therapy in patients treated for Bone and~     joint infection appears to be justified.~   "
19592|NCT03310528|"~     The purpose of this research study is to look at the effectiveness of current anesthesia~     guidelines regarding food and drink prior to surgery in patients who are likely to have food~     and drink remain in their stomach longer than might ordinarily be expected.~   "
19549|NCT03311087|"~     Although many studies have investigated the clinical benefits of nasal high flow during acute~     hypoxemic respiratory failure, there is no data (and even less so recommendations) on how to~     best conduct this technique, including its initiation and its weaning periods. Investigators~     will assess in a multicenter, observational study, the way clinicians use nasal high flow~     therapy in patients with acute respiratory failure in order to try identify one or more~     strategies that may be then compared in an interventional study.~   "
19550|NCT03311074|"~     Adenosine deaminase (ADA) is an enzyme involved in the development and functioning of the~     immune system. Deficiency of ADA results in severe combined immunodeficiency (SCID), a fatal~     inherited immune disorder. GSK2696273 is a gene therapy that aims to insert ADA function into~     blood cells and halt or reverse the conditions caused by decreased ADA enzyme levels, such as~     impaired immune function. It is important to consider long term follow-up of patients who~     have received GSK2696273, including evaluation of the risk of insertion near certain genes~     that may lead to unexpected activation of those genes (oncogenesis). The objective of this~     study is to evaluate the use of a new technique to identify where GSK2696273 has become~     inserted in the genetic sequence, and potential implications for patient care. This new~     technique is known as sonication linker mediated polymerase chain reaction (SLiM-PCR) for~     retroviral insertion site (RIS) analysis. The study will recruit at least 15 pediatric or~     adult patients with ADA-SCID who have been treated with GSK2696273, either in previous~     clinical trials or as a registered product. Recruitment for the study may remain open for up~     to 2 years even if 15 subjects are recruited sooner. Study participation will last for up to~     5 years. A total of 5 blood samples will be collected from each subject at approximately~     annual intervals. STRIMVELIS is a trade mark of the GSK group of companies.~   "
19551|NCT03311061|"~     The study is a an evaluation of the teen pregnancy prevention curriculum Decisions,~     Responsibility, Empowerment, Accountability, Motivations & Success (DREAMS) through a random~     control trial. The evaluation will take place in high schools in the greater Houston area.~     Five cohorts of two classes each in ten HS schools will be used. Randomization will occur~     each semester for five semesters. Curriculum is ten modules in length delivered in 45 minute~     classes twice a week for five weeks.~   "
19552|NCT03311048|"~     There are consistent evidences through epidemiologic studies in different places, reinforced~     by occupational asthma records studies, that cleaning workers have a high risk in developing~     asthma. These risk determinants are not totally known. The air around the worker may have~     some higher and lower molecular weight with different concentration peaks from removed dust~     of the cleaning process and volatile substances from cleaning products. Cleaning activities~     may occur in different places. Although the relationship between rhinitis and asthma is~     already established, there are not many studies about occupational rhinitis-related work~     place. This study aimed to investigate airway inflammation and respiratory symptoms of~     cleaning workers from different workplaces.~   "
19553|NCT03311035|"~     Abscesses and anal fistulas represent about 70% of perianal suppuration, with an estimated~     incidence of 1/10,000 inhabitants per year and representing 5% of queries in coloproctology.~      Anal fistula is the chronic phase of anorectal infection is characterized by chronic purulent~     drainage or cyclic pain associated with acute relapse of the abscess followed by intermittent~     spontaneous decompression.~      Perianal fistulas have a troublesome pathology. The most widely accepted theory is that anal~     abscess is caused by infection of an anal crypt gland. Suppuration moves from the anal gland~     to the inter-sphincteric space, forming an abscess leading to the development of a fistula.~     The incidence of fistula following an abscess is nearly 33%.~      A fistula can cause pain, perianal swelling, discharge, bleeding, and other nonspecific~     symptoms.~      The diagnosis of fistula-in-ano may include a digital rectal examination, endoanal~     ultrasound, fistulography, and MRI.~      The management of the disease is difficult and sometimes a challenge for the surgeon.~      The ideal treatment is based on three central principles: control of sepsis, closure of the~     fistula and maintenance of continence.~      The management of complex fistulas needs to balance the outcomes of cure and continence.~     Success is usually determined by identification of the primary opening and dividing the least~     amount of muscle as possible.~      There is a risk of sphincter muscle damage during fistulotomy, which can lead to an~     unacceptable risk of anal incontinence of varying degrees.~      The surgical techniques described for the treatment of fistula-in-ano are fistulotomy,~     core-out fistulectomy, seton placement, endorectal advancement flap, injection of fibrin~     glue, insertion of a fistula plug, video-assisted anal fistula treatment (VAAFT) and ligation~     of the intersphincteric fistula tract (LIFT), Surgical techniques are composed of 2 broad~     categories, including sphincter sacrificing procedures, such as, fistulotomy, fistulectomy~     and cutting seton. and sphincter-preserving procedures, such as fibrin glue injection,~     fistula plug, rectal advancement flap, VAAFT and LIFT. In general, sphincter sacrificing~     procedures have high success rates but are associated with high rates of fecal incontinence.~     In contrast, sphincter-preserving procedures have more modest success rates but are~     associated with a relatively minimal risk of changes in continence.~      While low transsphincteric fistulae are well-addressed by fistulotomy (i.e., lay-open~     technique) with minimal change in long-term bowel habits, fistulae which involve more than 30~     % of the internal sphincter carry a substantial risk of fecal incontinence with this~     approach.~      Endorectal advancement flap is technically difficult and associated with high recurrence rate~     up to 50% and risk of incontinence up to 35%.~      Fibrin glue and anal fistula plug have a little effect on incontinence but are associated~     with high recurrence up to 60 % and are costive.~      VAAFT is effective method but is highly costive.~      Setons can be employed as cutting and non-cutting kinds as dividers or markers . A few types~     of setons used are the Ayurveda-medicated thread , braided sutures thread, rubber band ,~     Penrose drains and cable tie seton . Seton material should be non-absorbable, from~     non-slippage material, comfortable and least irritant for the patient and equally ejective in~     causing focal reaction in the track, leading to fibrosis .~      However, setons may cause patient discomfort, both from irritation and from persistent~     drainage. In addition the incontinence rate may reach 67%.~      The ligation of intersphincteric fistula tract (LIFT) was first described by Rojanasakul and~     colleagues in 2007. Since then, this technique has become popular among providers due to its~     simple technical elements, particularly when compared to anorectal advancement flaps, and~     favorable success rate. Among the many studies published in the literature, the success rate~     after LIFT ranges from 40 to 95 %, with a recurrence rate of 6-28 % .3,5-28 In comparison,~     success after advancement flap ranges from 60 to 94 %.~   "
19554|NCT03311022|"~     The purpose of this study is to compare the bioavailability of Nefopam Hydrochloride 30mg~     Tablets (test product) and Acupan® 30mg Tablets (reference product).~   "
19555|NCT03311009|"~     This is a randomized, double-blind, placebo-controlled, stratified, ascending dose, single~     center study, in three semi-sequential cohorts of 10 male and female subjects of~     nonchildbearing potential with Osteoarthritis (OA), administered GLPG1972 or placebo. Per~     cohort, 10 subjects will be randomized in a 4:1 allocation ratio to active treatment with~     GLPG1972 or matching placebo. In each cohort, OA subjects will be stratified for age (50- 64~     years and 65-75 years) with a minimum of 2 of each sex per age group.~   "
19556|NCT03310996|"~     Intellectual impairments are a significant cause of morbidity in children with birth defects~     along with long term implication on academic and occupational functioning. Long lasting~     functional changes in the brain occur when children learn new things or memorise new~     information. Enhancing this and learning is a key objective inneurodevelopment and~     neuro-rehabilitation. This is pilot study aimed at testing a experimental neuroscience~     technique, Transcranial Direct Current Stimulation (tCDS) on the cognitive functioning of the~     brain in children with Neurofibromatosis type 1 (NF1). tDCS is an established research tool~     and has the potential for ameliorating the cognitive impairments associated with NF1. There~     is a growing interest in the use of tDCS in children but to our knowledge there have been no~     reported studies using tDCS intervention in NF1. 16 children aged 11-16 years will be~     recruited through the Manchester Centre of Genomic Medicine NF1 database. Participants will~     be randomised to receive active or sham tDCS. The treatment will be delivered for 20 minutes~     for 3 days. In the experimental group a 1mA current will be applied for 20 mins ; in sham~     tDCS the electrodes will be placed in an identical spot but the current is ramped down to 30~     seconds to prevent stimulation. The aim of the study is to look into the acceptability and~     feasibility of using tDCS intervention within the NF1 group, obtain pilot data on the effect~     of tDCS on EEG (Electroencephalogram), cognitive and behavioural measures.~   "
19557|NCT03310983|"~     The purpose of this study is to learn if participants in the ADORE study (NCT02626299), who~     took a DHA supplement during pregnancy, see favorable body fat in their infants from birth to~     24 months, and if excessive or appropriate weight gain during pregnancy impacts this result.~   "
19558|NCT03310970|"~     The study to be performed will utilize already FDA-approved marketed products in healthy~     adults for the purpose to generate data for establishing rate of drug delivery of Lidoderm®~     topical patch (manufactured by Endo Pharmaceuticals) and the lidocaine 5% patch (manufactured~     by Mylan Pharmaceuticals) in healthy adults, and to ensure the safety of individuals~     utilizing these types of products.~   "
19559|NCT03310957|"~     This trial studies SGN-LIV1A in combination with pembrolizumab to find out what their side~     effects are and if they work for patients with triple-negative breast cancer that has spread~     to other parts of the body. Patients will be given both experimental drugs every 3 weeks.~   "
19724|NCT03308812|"~     This study will recruit from participants in the Morehouse-Emory Cardiovascular (MECA) study~     for a clinical intervention examining cardiac outcomes between participants who are~     randomized to received Health360x (a web-based and mobile-based application) or Health360x~     plus personalized health coaching. Participants will receive instruction on using the~     Health360x application and will use Health360x alone or Health360x with a health coach for 6~     months. Measures of cardiovascular health will be assessed at baseline and after the 6 month~     long intervention.~   "
19560|NCT03310944|"~     Primary Objective:~      To assess the relative bioavailability of sotagliflozin following single doses of 3~     sotagliflozin prototype tablet formulations p1, p2 and p3 versus the reference tablet~     formulation in fasted conditions in healthy subjects.~      Secondary Objectives:~        -  To assess the pharmacokinetic characteristics of sotagliflozin and its 3-O-glucuronide~          following single doses of 3 sotagliflozin prototype tablet formulations p1, p2 and p3~          and of the reference formulation in fasted conditions in healthy subjects.~        -  To assess the clinical and laboratory safety of single oral doses of 3 sotagliflozin~          prototype tablet formulations p1, p2 and p3 and the reference tablet formulation in~          fasted conditions in healthy subjects.~   "
19561|NCT03310931|"~     The purpose of this study is to evaluate whether Thromboelastography (TEG) parameters on~     admission might be predictive for early neurological deterioration in acute ischemic stroke~     patients, specifically for the DWI lesion evolution within the first week after stroke onset.~   "
19562|NCT03310918|"~     This research study is evaluating the impact a collaborative palliative care and oncology~     team will have on end-of-life outcomes, quality of end-of-life care, and the quality of life,~     symptoms, and mood of patients with acute myeloid leukemia (AML) receiving non-intensive~     therapy~   "
19563|NCT03310905|"~     The purpose of this protocol is to determine the safety and efficacy of abdominal wall~     transplantation as a treatment for the reconstruction of abdominal wall defects. Abdominal~     wall transplantation may be performed alone or in combination with another transplant.~   "
19564|NCT03310892|"~     This is a randomized controlled trial to to determine whether direct, tailored messaging to~     patients prior to scheduling colonoscopy will increase patient adherence to provider~     recommendation for screening colonoscopy.~   "
19565|NCT03310879|"~     This research study is studying a targeted therapy as a possible treatment for cancer~     abnormality in one of the following genes: CCND1, CCND2, CCND3, CDK4, or CDK6.~      The drug involved in this study is:~      -Abemaciclib~   "
19566|NCT03310866|"~     During fiberoptic endotracheal intubation, the perfect airway exposure produced by the~     classic curved Macintosh laryngoscope in place of head tilt -chin lift-jaw thrust maneuver~     may increase the accuracy and produce rapid direct vocal cord access in a short time under~     Inhalation anesthesia to maintain the respiratory drive for grade III&VI Modified Mallampati~     .~   "
19567|NCT03310853|"~     This phase 2 study evaluates the effect of perinatal use of probiotics on the number of~     diagnosed viral, bacterial and fungal infections in pregnant women and on the maintenance of~     a health pregnancy. In addition, the effect of probiotics intake during pregnancy and~     breastfeeding on the infant's overall health status will be evaluated.~   "
19568|NCT03310840|"~     Hospital acquired infection is an important cause of mortality and morbidity among infants in~     neonatal intensive care units. Surveillance cultures are performed routinely in many units to~     monitor infants at risk of sepsis.~      Mechanically ventilated babies face particular risk because artificial airways bypass the~     body's defenses against inhaled pathogens and offer new routes for non airborne pathogens.~     Intubation associated lesions of pharynx and trachea lead to bacterial colonisation by the~     deterioration of the swallowing reflex and the ciliary functions. Subsequently, these babies~     may develop pneumonia and sepsis.~      cultures of aspirates obtained through endotracheal tubes from ventilated infants are~     monitored on the assumption that the organisms that are colonising the respiratory tract will~     be the same pathogens as those isolated from the blood during episodes of sepsis.~   "
19569|NCT03310827|"~     To evaluate the feasibility of nutrigenomics as an intervention for mental health conditions,~     a phase I randomized controlled trial of 42 adults (19 to 50 years) with depressive disorders~     using a 2:1 ratio of group selection (28 in the intervention {I} group and 14 in the control~     {C} group) is proposed. Participants with a confirmed depressive disorder will be recruited~     from two local mental health clinics. Those randomized into the I group will do the gene~     testing and be provided personalized DNA-based dietary advice from a registered dietitian;~     those in the C group will also receive testing but be given general dietary advice by a~     registered dietitian. Pre- and post-intervention comparisons (3 and 6 weeks after a~     personalized nutrition plan is given) will be analyzed based on records of dietary intakes~     (i.e., 3 day food records and food frequency questionnaire) and psychiatric functioning~     (e.g., Quick Inventory of Depressive Symptomology, Hospital Anxiety and Depression Scale,~     Outcome Questionnaire - OQ-45). In addition, measures that track physical activity, sedentary~     behavior, and sleep quality as well as sociodemographics will be included as covariates.~     After the intervention study is completed, in-depth focus group interviews will be conducted.~     Participants will be asked questions that will elicit their perceptions of the nutrigenomics~     test and the personalized dietary advice provided as well as the behavioural response to~     disclosure of genetic information.~   "
19570|NCT03310814|"~     This study compares the efficacy of a non-practitioner assisted direct-to-consumer (DTC)~     self-driven approach to nutrigenomics versus a personalized practitioner-led method. The~     secondary aims are to use this data combined with participant feedback to generate more~     effective nutrigenomics-based products.~   "
19571|NCT03310801|"~     This study will retrospectively review and compare clinical outcomes between left atrial~     appendage occlusion with dual antiplatelet therapy versus conventional antithrombotic therapy~     in patients with atrial fibrillation undergoing drug-eluting stent implantation.~   "
19572|NCT03310788|"~     The purpose of this study is to investigate how much selective trabeculoplasty (SLT)~     influences intraocular pressure (IOP) fluctuations measured with iCare Home rebound tonometry~     (RTHome) in patients with primary open-angle glaucoma (POAG) or pseudo-exfoliation glaucoma~     (PEX).~   "
19573|NCT03310775|"~     Despite the psychosocial difficulties common among young adults with autism spectrum~     disorders(ASD), little to no evidence-based social skills interventions exist for this~     population. Using a randomized controlled trial(RCT) design, the current study tested the~     effectiveness of an evidence-based, caregiver-assisted social skills intervention known as~     PEERS for Young Adults with high-functioning young adults with ASD using self- and~     caregiver-report measures.~   "
19725|NCT03308799|"~     This trial is a randomized, investigator-blind, multicentre, vehicle- and~     comparator-controlled, parallel-group trial with the purpose of evaluating efficacy, safety~     and convenience of the MC2-01 cream.~   "
19574|NCT03310762|"~     Pakistan has one of the highest infant mortality rates in the world in part, due to the low~     coverage (54%) for all basic vaccinations. Low uptake, lack of awareness among parents to~     complete the recommended immunization schedule and inability to remember vaccine appointments~     are some of the key factors hindering improvement in uptake of immunization services. On the~     supply side, ineffective methods to track children's' vaccine doses means that there is no~     reliable mechanism to verify vaccine administration and estimate accurate immunization~     coverage.~      This study proposes to develop and test two types of silicon bracelets for children to~     stimulate immunization demand and simultaneously address supply side verification issues.~     These bracelets use a combination of numbers and symbols to denote the age of the child and~     due vaccines and are designed for illiterate or uneducated mothers; are low-cost and~     adaptable to most local settings. At the time of vaccine administration, the appropriate~     symbol denoting the vaccine on the bracelets is punched and therefore the bracelets can serve~     as effective reminders for mothers for timely immunization of their child and as a tool for~     vaccinators to verify vaccine administration and coverage.~      An individually randomized, three-arm parallel group design randomized control trial will be~     conducted with equal allocation in the two treatment groups and control group. Children in~     intervention group A will receive the simple silicon bracelets, children in intervention~     group B will receive the bracelets developed by Alma Sana Inc. and children in the Control~     group will not receive any intervention. The impact of these immunization reminder bracelets~     on immunization coverage and timeliness will be evaluated through a randomized control trial~     (RCT) across 4 immunization centers in Karachi. To evaluate the bracelets' impact, variables~     of interest-coverage and timeliness rates of pentavalent-3/PCV-3/polio-3 and Measles 1~     vaccine will be compared between Group A and the Control Group and Group B and the Control~     Group.~      Proposed results include increase in immunization coverage and timeliness of~     Pentavalent-3/Pneumococcal Conjugate Vaccine (PCV-3)/Polio-3 and Measles-1 in the~     intervention versus control group.~      The study will provide evidence of the bracelet's effectiveness for the global health~     community and provide a simple tool for strengthening routine immunization efforts in~     Pakistan.~   "
19575|NCT03310749|"~     This is an open, randomized (randomization ratio: 1:1), multiple dose, three way, three~     period cross over study to assess the potential for drug drug interactions between~     gemigliptin (a DPP-IV inhibitor mainly metabolized by CYP3A4) and metformin in a sample of~     healthy Mexican volunteers, aimed to determine whether the observed lack of drug-drug~     interactions between gemigliptin and metformin in the Korean population is reproducible in an~     ethnically different population characterized by a significant difference in the frequency of~     CYP3A4 polymorphisms associated with decreased enzymatic activity, such as CYP3A4*1b, in~     comparison with Asian populations.~   "
19576|NCT03310736|"~     This is a single center, prospective, observational study to demonstrate the clinical~     validity of the Intrinsic LifeSciences (ILS) Intrinsic Hepcidin IDx™ Test in the diagnosis~     and management of iron deficiency (ID) in adolescents and young adults. This test is~     considered non-significant risk.~   "
19577|NCT03310723|"~     A trial comparing outcomes of two pre-oxygenation techniques in obstetric patients.~   "
19578|NCT03310710|"~     Fenestrated endovascular abdominal aortic aneurysm repair (FEVAR) is a procedure to treat~     abdominal aortic aneurysms which are not amenable to conventional repair or stenting. A stent~     is placed in the aorta and confines blood flow to a normal diameter lumen to remove pressure~     on the diseased aortic wall. Fenestrations (custom holes in the graft) are necessary to~     maintain blood flow to abdominal organs when the aneurysm sac extends to far proximally.~     These fenestrations are then typically aligned with their respective vessels using covered~     stents. These stents also help keep the arteries open.~      Unfortunately some of the stents currently used occlude either immediately or over time,~     which can lead to organ failure, morbidity and death. A recent advancement in stent design~     has heparin bonded to the stent surface which prevents clot from forming. This new design has~     been shown to help maintain stent patency in other parts of the body. The investigators~     believe it may do the same for FEVAR patients. The proposed study is a 20-patient pilot to~     assess the safety of substituting a heparin bonded stent graft for FEVAR branches over a~     period of one year. Patients who are deemed eligible for FEVAR by a UHN multidisciplinary~     vascular conference will be recruited to the study. All the branches in their FEVAR will use~     the Viabahn BX stent in place of the current standard of care stent. They will then be~     followed per the standard of care for one year. Adverse events will be recorded and the rate~     of occlusion will be assessed based on CT imaging.~      The investigators hypothesize that using heparin bonded stent grafts is safe and they will~     have a low rate of occlusion.~   "
19579|NCT03310697|"~     Before the age of 14 years, 1% of the paediatric population will develop a seizure. The only~     systematically required complementary examination is an electroencephalogram (EEG).~     Additional biological or radiological examinations depend on the circumstances, the past~     medical history of the patient and other associated symptoms or clinical signs. A seizure can~     be the first sign of acute intoxication and represents a severity criterion. Failure to~     detect the toxic cause of a seizure can lead to a delay in the access or administration of an~     antidote if applicable. This can lead to target organ toxicity due to the absence of specific~     treatment. In the current French guidelines for a first seizure, a toxicological analysis is~     recommended if there is a possibility of exposure to toxic medications or products. However,~     this screening is often missing, unless a witness suggests that the child may have been~     exposed to a toxin.The recognition of a paediatric toxidrome is low among paediatricians,~     paediatric neurologists or emergency physicians. This is due to a lack of knowledge in~     clinical toxicology and the screening for toxic aetiology is not frequently or irrelevantly~     prescribed. There is an increasing number of proconvulsive molecules on the market. These~     molecules are not targeted in classic toxic screening. As result, a toxic cause of a seizure~     may be missed unless specific screening is performed. For all these reasons, little is known~     about the prevalence of toxic causes after a first episode of non-febrile seizure and~     probably under estimated in the paediatric population, especially in young children. New~     technologies for toxic detection like chromatography combined with mass spectrometry allow~     wide screening on different matrix. Initially dedicated to forensic analysis, they are more~     widely accessible for the exploration of the patients. The CASTox study is based on this~     context.~      The first aim will be to evaluate the prevalence of a toxicological cause by a systematic~     blood and urine screening of children admitted to Toulouse paediatric emergency unit for a~     first afebrile seizure. Moreover, secondary aim will be to describe the effect of the~     systematic screening on the management of the children.~   "
19580|NCT03310684|"~     Pediatric primary hypertension is increasingly common, occurring in 5-10% of normal-weight~     children and up to 25% of children with obesity. It is a risk factor for adult cardiovascular~     and renal disease. But even during childhood, hypertension is associated with significant~     morbidity, including cognitive impairment and organ damage. In the heart and kidneys, this~     organ damage is characterized by thickened heart muscle (left ventricular hypertrophy) and~     spillage of protein in the urine (albuminuria). Obese children are also at risk for fatty~     liver disease. However, the cause of pediatric primary hypertension, the role of obesity, and~     the mechanisms behind heart and kidney injury are poorly understood. Due to these~     limitations, there are no first-line medications, and treatment is often inadequate. An~     altered renin-angiotensin system may cause primary hypertension and related organ damage.~     Evidence suggests uric acid, FGF23, klotho, and obesity play a role in renin-angiotensin~     system-mediated injury. An improved comprehension of the pathophysiology of pediatric primary~     hypertension could enhance clinical care by targeting treatment to the cause of disease and~     informing novel measurement of organ damage.~   "
19726|NCT03308786|"~     The purpose of this pilot study is to examine the effects of eight 5-day cycles of~     subcutaneous recombinant interleukin-2 (rIL-2) given every 8 weeks on levels of~     replication-competent HIV in CD4 cells and on the size of HIV viral reservoir in up to 20~     participants with chronically suppressed HIV infection (viral load <50 copies/mL).~   "
19581|NCT03310671|"~     Aortic stenosis (AE) is a disease that has been increasing steadily in recent years in most~     countries, including Spain.Risk factors for the development of AE include age,~     hypercholesterolemia, diabetes mellitus and arterial hypertension, the classic risk factors~     for the development of atherosclerosis. However, lipid-lowering therapy with statins and~     ezetimibe has not been shown to reduce the risk of long-term progression of AE by unknown~     mechanisms. All this suggests that subjects with HFhe have a high risk of developing AD,~     which has not been shown by the high coronary mortality in this population that precedes~     aortic calcification~   "
19582|NCT03310658|"~     ZSX Medical completed enrollment in its First in Human Ease of Use study in May of 2017, in~     Monterrey Mexico. The purpose of this study is to demonstrate the ease of use of Zip-Stitch™,~     to generate first in human data, and to refine surgical technique of the device.~      Ten subjects were enrolled and received total laparoscopic hysterectomies, including vaginal~     cuff closure with the Zip-Stitch™ system during their otherwise standard care. Procedures~     took place over the course of one week. Subjects had in person follow-up appointments at 1~     and 6 weeks. Subjects are continuing follow-up through a one-year extension period which will~     end in May 2018.~   "
19583|NCT03310645|"~     To investigate the safety and tolerability of ascending repeated oral doses of BAY1817080 in~     healthy volunteers(Part1).~      To investigate the safety, tolerability and efficacy of BAY1817080 in patients with~     refractory chronic cough(Part2).~   "
19584|NCT03310632|"~     Antroquinonol is proposed for the treatment of neoplasms. The proposed clinical trial is a~     Phase I/II study designed to evaluate antroquinonol in combination with nab-paclitaxel and~     gemcitabine in first line treatment naïve subjects with Stage IV metastatic pancreatic~     carcinoma. The first part of study will focus on the treatment of pancreatic cancer with 200~     mg TID and 300 mg TID, clinical treatment duration of 4 weeks, to determine the MTD or MFD~     (based on PK and capsules strength) of antroquinonol in combination with a standard dose~     regimen of nab-paclitaxel and gemcitabine. The extended Phase II will focus on the efficacy~     of antroquinonol with SOC. Safety and pharmacokinetic profiles will be studied in the~     proposed clinical trial.~   "
19585|NCT03310619|"~     This is an open-label, multi-arm, multi-cohort, multi-center, Phase 1/2 study to determine~     the safety, tolerability, PK, efficacy and patient reported quality of life of JCAR017 in~     combination with various agents. The first combination, defined as Arm A, will evaluate~     JCAR017 in combination with durvalumab. Within each arm, cohorts and subcohorts will test~     different doses and schedules of the combination agent(s).~      The study will consist of 2 parts: dose finding (Phase 1) and dose expansion (Phase 2).~   "
19586|NCT03310606|"~     SPAC is a pilote monocentric prospective study about peritonitis and antibiotics~     pharmacokinetic and pharmacodynamic. The investigators will included 50 patients during 2~     years in the University Hospital of Nancy.~      The aim of this study is to determine if the beta-lactam dosages recommended by the~     guidelines for management of intra-abdominal infections (published by the Société française~     d'anesthésie et de réanimation (Sfar) in december 2015) permitted the achievement of~     adequatly serum and peritoneal concentrations in the medical and surgical management of~     peritonitis.~      The investigators will collected 3 pairs of serum and peritoneal fluid samples at 3 different~     times: peritoneal incision, arrival in ICU and 24 hours after admission in ICU in order to~     compare the concentrations and the minimal inhibitor concentration of bacteria.~      The hypothesis is that of a serum and peritoneal antibiotic under dosage.~   "
19587|NCT03310593|"~     Depressive symptoms are associated with significant psychosocial impairment. However, current~     treatments of bipolar depression are only partially effective.~      Cannabidiol is a natural component of cannabis without psychotomimetic or addictive~     properties. Cannabidiol has been shown to produce therapeutic effects including~     anticonvulsive, anxiolytic, antipsychotic and neuroprotective effects. The investigators~     hypothesize that treatment with cannabidiol will result in improvement of depressive and~     anxiety symptoms, as well as, improvement in functioning and inflammatory biomarkers. During~     the clinical trial subjects will receive study medications (cannabidiol 600mg/day or placebo)~     for a period of 12 weeks.~   "
19588|NCT03310580|"~     To test the safety and effectiveness of netarsudil 0.02% and 0.04% ophthalmic solution~     relative to placebo in Japanese/Japanese-American subjects with elevated intraocular pressure~   "
19589|NCT03310567|"~     Expression of IDO and PD-1/L1 has been found to be increased in endometrial cancer.~     Expression of these markers on the tumor cells leads to immunosuppression in the~     micro-environment of tumors that prevents immune system from attacking and killing tumor~     cells. The purpose of this trial is to target these antigens by concomitant administration of~     drugs epacadostat and pembrolizumab, thereby removing twin mechanisms of immune-suppression~     that may lead to better control of tumor growth.~   "
19590|NCT03310554|"~     Endoscopic insertion of plastic or metal stents in introhepatic bile duct under endoscopic~     retrograde cholangiopancreatography is a well established treatment of malignant or benign~     biliary obstruction.Biliary stents are widely used to relieve symptoms of biliary~     stricture.Now, the mainly used biliary stents include plastic and metal stents. The main~     limitation of long time plastic stents is stents occlusion. Biliary plastic stents are~     changed every 2 to 3 months due to an expected median patency from 77 to 126 days.Metal~     stents present a lower risk of recurring biliary occlusion, yet high cost and stents~     occlusion are eventually inevitable. The mechanism of biliary stents occlusion include~     biliary sluge of the accumulation of bacteria and duodenal biliary reflux .The anti-reflux~     barrier of Oddi's sphincter disappears after the insertion of biliary stents and the presure~     in bile duct lowers the duodenals, which cause the retrograde flow of duodenal material into~     the biliary ducts. Besides, ordinary biliary plastic stent is short which can also shortens~     the length of duodenal biliary reflux . Therefore, trying to prevent the duodenal biliary~     reflux is very important in reducing biliary stents occlusion and it is gradually concerned~     by clinical researchers. Some studies have showed that plastic stents with antireflux valves~     can effectively reduce the biliary stent stricture and prolong the stents patency, which~     means reducing duodenobiliary reflux is surely useful for keeping biliary stent patency.So,we~     assume to explore an innovatively suspended overlength biliary stents (reformed with~     nasobiliary tube ) as substitution for ordinary biliary plastic stent to prevent the~     duodenobiliary reflux by extending the length of duodenal content reflux and avoid the stents~     shift via suspending in intrahepatic duct. In this study,we will design a stratified~     randomized controlled trial to compare the patency of different length of suspended~     overlength biliary stents and ordinary plastic biliary stents in patients with malignant and~     benign biliary obstruction respectively to evaluate the effect of suspended overlength~     biliary stents for the prevention of duodenobiliary reflux and the effect of different length~     of the stents.~   "
19591|NCT03310541|"~     This study will test the recommended dose of AZD5363 (recommended from a previous phase 1~     study of the drug) in patients with specific AKT mutations. In patients who have ER positive~     breast cancer with an AKT mutation, they will also be receiving a standard breast cancer drug~     called fulvestrant that is given as an injection. In patients who have prostate cancer with~     an AKT mutation, they will also be receiving a standard prostate cancer drug called~     enzalutamide that is taken orally.~   "
19593|NCT03310515|"~     Studies to assess the effectiveness of interventions to prevent HIV infection depend upon~     robust estimates of Baseline HIV incidence rates. The changing landscape of high-risk~     populations, as well as the evolution of biomedical pre-exposure prophylaxis (PrEP)~     interventions, requires a contemporary evaluation of HIV incidence as well as demographic,~     behavioral and other subject factors which may impact HIV incidence. This is a prospective~     cohort study to measure HIV-1 seroincidence in a study population of HIV-1 uninfected Chinese~     men who have sex with men (MSM) and transgender women (TGW) who are at high-risk of HIV~     infection. Approximately 550 subjects who are male sex at birth and have sex with men shall~     enter the study, which will allow for a 10% drop out rate to maintain 500 subjects at the~     conclusion of the cohort. This is a single arm cohort study to determine HIV-1 seroincidence~     rates in high risk MSM and TGW when combined with a comprehensive prevention package~     including HIV and safe sex counseling, provision of condoms and water-based lubricant, and~     sexually transmitted infection (STI) screening and referral for treatment. It will be~     determined what proportion of high-risk MSM and TGW who are given a comprehensive HIV-1~     prevention package will acquire HIV-1 infection.~   "
19594|NCT03310502|"~     Aim of the study is to investigate genes regulating glucose and lipid metabolism in subjects~     whose glucose metabolism, lipid metabolism, blood flow, or body fat distribution has been~     measured using positron emission tomography (PET), magnetic resonance imaging (MRI), magnetic~     resonance spectroscopy (MRS) or computed tomography (CT) as part of their previous~     participation in clinical trials conducted at Turku PET Centre.~      By combining information from PET, MRI, CT, proteomics, metabolomics and genetics analyses we~     aim to find connection between genetic variation and metabolic and cardiovascular disease.~   "
19595|NCT03310489|"~     The aim of the study is to evaluate the effectiveness of a digitalized cognitive-behavioral~     treatment for anxiety among school aged children. The participants are screened from the~     general population, as a part of the routine school health care check-ups. Half of the~     children with anxiety will receive the digitalized treatment program, while the other half~     will receive education about anxiety in internet.~   "
19596|NCT03310476|"~     Resistant starch (RS) is a type of fiber that has unique digestive properties that can impact~     overall health including glucose homeostasis and satiety. RS found in potatoes can be~     increased by using certain cooking methods and serving temperatures. The purpose of this~     trial will compare the acute glycemic and satiety responses after consuming potatoes~     differing in RS content that are 1) baked then chilled or 2) boiled and consumed hot in~     overweight females on two separate occasions.~   "
19597|NCT03310463|"~     This research project is being conducted to look at the pharmacokinetics (PK; how the human~     body processes a substance), safety, and tolerability of a single dose of ETX2514 and~     sulbactam (ETX2514SUL) when concurrently administered by separate intravenous (IV) infusion~     in participants with various degrees of renal impairment (RI), in participants with end-stage~     renal disease (ESRD) who are on hemodialysis (HD), and in healthy matched control~     participants with normal renal function.~   "
19598|NCT03310450|"~     Prospective observational study to determine predictors that related to cardiac troponin I~     (cTnI)release, malondialdehyde (MDA) and high sensitivity C Reactive Protein (hs-CRP) after~     Tour de Borobudur (TdB) 2017~   "
19599|NCT03310437|"~     Cost effectiveness between PPCI and thrombolytic therapy in STEMI patients without~     contraindications~   "
19600|NCT03310424|"~     Syphilis is an important sexually transmitted infection. There has been an epidemic of~     syphilis amongst men who have sex with men in the United Kingdom in the last decade. Early~     infection with syphilis causes a genital ulcer followed, in the absence of treatment, by a~     generalised illness often accompanied by rash. Studies on the pathogenesis of syphilis have~     been limited because it is not possible to grow syphilis outside of the body. New approaches~     using molecular tests allow the immune response of the patient to infection to be measured~     directly from a swab of a genital ulcer or rash and/or a blood sample and also allow the~     whole genetic sequence of the bacteria to be obtained from a swab.~      In this study the investigators will collect swabs from ulcers or rashes and a blood sample~     from patients with syphilis and measure both the response of the patient immune system and~     the genetic sequence of the bacteria. Patients will be enrolled at sexual health clinics in~     the United Kingdom. Patients will receive standard medical care including standard treatment~     for syphilis in line with national guidelines. Standard management already includes~     collection of a swab and a blood sample. For this study an additional swab sample and an~     additional 5ml of blood will be collected for use in this research project. By better~     understanding host immune system responds to infection with syphilis the studies aims to gain~     better insights in to the pathogenesis of this important sexually transmitted disease.~   "
19601|NCT03310411|"~     The purpose of this study is to assess whether taking lasmiditan and sumatriptan together~     will have any additional effects on heart rate and blood pressure compared to taking~     lasmiditan and sumatriptan individually. This study will also look at the amount of study~     drug that gets into the blood stream and how long it takes the body to get rid of it when~     these two drugs are taken together.~      This study will last about 21 days, not including the screening. Participants will spend 16~     days/15 nights in the clinical research unit (CRU) followed by follow-up. Screening is~     required within 28 days prior to the start of the study.~   "
19602|NCT03310398|"~     Anxiety and depression are highly prevalent and disabling conditions that frequently~     co-occur, and are costly to the individual and society. Despite important advances in our~     understanding of these disorders, there is a significant unmet need to identify reliable and~     clinically useful tests that can predict prognosis, inform treatment choice for a given~     individual, and improve treatment outcomes. The aim of this project is to fill this critical~     gap by validating a battery of measures including brain imaging, psychophysiology, behavior,~     and self-report that will reliably assess positive and negative affect, or valence, system~     functioning in a broad sample of individuals screened for anxiety and depression as part of~     their routine primary care visits.~   "
19734|NCT03308669|"~     This study will assess the safety, tolerability and blood concentrations of lasmiditan and~     topiramate together compared to lasmiditan and topiramate separately. Information about any~     side effects that may occur will be collected.~      Participants will be admitted to the Clinical Research Unit (CRU) one day prior to the start~     of the study and will remain through Day 14.~      This study is expected to last approximately 25 days, not including screening. Screening is~     required within 28 days prior to the start of the study.~   "
19603|NCT03310385|"~     This study is a phase 2, multicentre, dose-finding, double-blind, randomized~     placebo-controlled trial to evaluate the efficacy and safety of two different doses of GHX02,~     compared with placebo, for acute bronchitis. One-hundred and fifty patients will be included~     in this trial and randomly assigned to either a high-dose GHX02 group(1920mg/day),~     standard-dose GHX02 group(960mg/day), or control group(placebo) in a 1:1:1 allocation ratio.~     Patients will take one of the medications three times a day for 7 days, with 3 visiting~     days(screening, day0, day7). On the screening day, the Korean Standard Tool of Pattern~     Identification of Cough and Sputum, a diagnostic system that determines therapy in~     Traditional Korean Medicine, will be used to allocate patients into three groups of~     wind-heat, wind-cold or others.~   "
19604|NCT03310372|"~     The main purpose of this study is the evaluation of concomitant association of~     ultrafractionated irradiation and Temodal® in patients with inoperable primary glioblastoma~     multiforme; study of tolerance and objective response rate.~      The secondary purposes of this study are the evaluation of progression free survival, global~     survival and tolerance through toxicity study. The therapeutic response according to~     methylation or not of MGMT is also evaluated.~   "
19605|NCT03310359|"~     Astaxanthin is a natural compound, present in many foodstuffs and available as a nutritional~     supplement that has been shown to have beneficial effects on many of the features of insulin~     resistance/glucose intolerance, at least in animals. The goal of this project is to provide a~     validation of astaxanthin effects on metabolic regulation in humans and their mechanism(s) of~     action, to determine if astaxanthin could have any value as a neutraceutical to help~     improve regulation of glucose and fat metabolism in subjects with insulin resistance/ glucose~     intolerance.~   "
19606|NCT03310346|"~     The purpose of this prospective research registry is to collect data on treatment strategies~     and outcomes for premature newborns with severe pulmonary hypertension (PH).~   "
19607|NCT03310333|"~     The objective is to demonstrate the superiority of the strategy of labor induction by Cook®~     cervical ripening balloon between recommended strategy by dinoprostone (propess®) on the~     reduction of the time between cervical ripening and delivery in case of unfavorable cervix~     after 12 hours of PROM in term pregnant women.~   "
19608|NCT03310320|"~     The Sponsor is developing the study drug, AZD0284, for the potential treatment of Plaque~     psoriasis. Psoriasis is a skin condition that causes red, flaky, crusty patches of skin~     covered with silvery scales. The severity of the disease varies, but in many cases it can~     have a major impact on their quality of life if not adequately treated.~      The purpose of the study is to determine the short term safety, pharmacodynamic and clinical~     effect of AZD0284 in patients with psoriasis.~   "
19609|NCT03310307|"~     100 overweight reproductive vitamin D deficient women were divided into two groups; vitamin D~     (n = 50) and placebo (n = 50). Vitamin D group received treatment dose of 50,000 IU of~     vitamin D3 per week for 2 consecutive months and placebo group received placebo tablets~     similar in size, shape and color to vitamin D3 for 2 months also. Total homocysteine~     concentrations were measured before intervention (basal), on 30 days (one month) and on 60~     days (2 months) of intervention. Changes in means of homocysteine concentrations for placebo~     and vitamin D group over time showed significant difference on 30 and 60 days of~     intervention. Mean comparisons of homocysteine concentrations and standard error of the means~     before and after intervention showed statistical significant decrease in homocysteine~     concentrations among vitamin D group.~   "
19610|NCT03310294|"~     Herpes labialis (HL) is the result of the presence of a virus called HSV-1 and is a common~     disease. Because of its visibility due to cold sores it has a serious impact on social life.~     Until now there is no effective treatment to prevent virus outbreaks. However, prebiotics and~     probiotics have both been shown to have a favorable and supportive effect on the immune~     system in different health conditions such as influenza, atopic dermatitis and diarrhea, so~     it is possible that they are able to have a favourable effect also on HL.~      A recently completed pilot clinical trial (Protocol Number 08-SBUS-2-GRA-01, EVIM-1) was~     completed using a fermented milk (minidrink) containing a combination of L. rhamnosus and~     FOS; it showed promising results in the reduction of HL recurrences in a population of 78~     subjects with HSV-1. The study investigated the effect of pre- or probiotics or a combination~     of the two on the recurrence of HL lesions as well as on the immune system in general,~     showing that the consumption of a minidrink containing the probiotic L. rhamnosus or a~     minidrink containing a combination of L. rhamnosus and FOS reduced the occurrence and the~     incidence of recurrent HL lesions.~      Aim of this study: corroborate whether the consumption of a minidrink containing a~     combination of L. rhamnosus and FOS results in less recurrence and a better progression of HL~     lesion, in a larger population. In addition, the response of the consumption of the minidrink~     on the QoL and the response on immunity specific biomarkers were evaluated.~      Design: 152 patients were eligible to participate in the study and after a run-in period of~     two weeks consuming a placebo minidrink were randomized to one of the two experimental study~     groups: placebo minidrink (n=79) and a minidrink containing a combination of a pre- and~     probiotic (n=78). These minidrinks were consumed until the end of the study (day 140). At day~     33 of the study the lip most prone to the development of a lesion was stimulated with UVB to~     provoke a lesion. During the entire study period subjects were checked for any clinical signs~     of a lesion, completed a self-assessment regarding the lesion and a QoL questionnaire at~     baseline (day 14), at day 49 and the end of the study (day 140). In addition, a blood sample~     was collected at baseline, at day 49 and at the end of the study to be analyzed for~     HSV-specific antibody concentrations , to check immune system specific functions.~   "
19611|NCT03310281|"~     The purpose of this study is to evaluate the effects of videogame-like digital therapies as~     adjunct therapy to antidepressant medications on cognitive deficits associated with major~     depressive disorder.~   "
19612|NCT03310268|"~     The purpose of this study is to provide evidence of clinical efficacy of an experimental~     dentifrice containing stannous fluoride (SnF2) compared to regular fluoride dentifrice in the~     reduction of dentinal hypersensitivity (DH). This study will be considered successful if~     there is a statistically significant difference in the primary efficacy variable, change from~     baseline in Schiff sensitivity score, after 8 weeks of treatment.~   "
19613|NCT03310255|"~     Upper gastrointestinal (GI) symptoms are frequent in organ transplant recipients. Peptic~     ulcers and related pathologies such as gastritis and duodenitis are known to occur with~     increased frequency (20-60%) and severity in renal transplant recipients. The frequency of~     severe complications is about 10% among transplant recipients and 10% of those might prove~     fatal As kidney transplant recipients have to take immunosuppressive drugs for a lifetime and~     because these drugs have many side effects that may not be differentiated from H. pylori~     infection Thus, in order to reduce the use of medications and subsequently to reduce the drug~     interactions ,proper detection and management of H pylori infection in those patients is~     preferred.~   "
19614|NCT03310242|"~     This study aimed to compare the effects between sunlight exposure and oral vitamin D~     supplementation on serum 25-hydroxyvitamin D concentration and metabolic markers in Korean~     young adults.~   "
19735|NCT03308656|"~     To evaluate the performance of uterocervical angle (UCA) in the prediction of labor~     induction.~   "
19736|NCT03308643|"~     To evaluate the effects of oxytocin infusion during abdominal myomectomy.~   "
19615|NCT03310229|"~     High mortality rates due to cardiovascular disease in end-stage renal disease patients been~     described by epidemiological and clinical studies. It accounts for approximately 50 percent~     of deaths in dialysis patients. Although controversial, this may be due to the presence of~     excess vascular calcification particularly in the form of extensive coronary artery~     calcification which can be observed even in very young dialysis patients. It was suggested~     that abnormalities of the right ventricular function in patients with end-stage renal disease~     were largely due to pulmonary hypertension which usually develops secondary to pulmonary~     artery calcifications.~   "
19616|NCT03310216|"~     In this study, the investigators provide participants from ophthalmic clinic the AI visual~     inspection system and EDTRS in the purpose of seeking out a better way of visual inspection~     with high efficiency and accuracy, and report a prospective, randomized controlled study~     aiming at comparison of AI visual inspection system and EDTRS for visual inspection.~   "
19617|NCT03310203|"~     A total of 126 premenopausal women (42 lean, 42 obese with central obesity, 42 obese with~     peripheral obesity) will be recruited. Anthropometric measurements and body composition using~     DEXA will be collected. Overnight fasted subjects will be asked to give baseline blood~     samples before consuming a meal containing 6 mg 57Fe in the form of FeSO4. Subjects will~     return after 14 days and a blood sample will be collected for measurement of isotopic~     enrichment into red blood cells, serving as well as a baseline for the OGTT. Subjects will~     then be asked to ingest a solution of glucose (50g) containing 100 mg of iron in the form of~     sodium ferrous citrate (SFC), after which blood samples will be collected 2 hours post iron~     and glucose load. All three blood samples collected at baseline, 2 weeks post labeled iron~     load, and 2 hours post glucose/iron load will be analyzed for their levels of iron, glycaemia~     and inflammatory parameters.~   "
19618|NCT03310190|"~     A study to assess the real-life management and use of healthcare resources during the~     initiation of venetoclax in participants with chronic lymphocytic leukemia (CLL) with the~     deletion of the short arm of chromosome 17 (del[17p]) who have received at least 1 prior~     therapy or participants with CLL without del(17p) who have received at least 1 prior therapy~     and for whom there are no other available treatment options.~   "
19619|NCT03310177|"~     Despite the high prevalence of chronic obstructive pulmonary disease (COPD), there continues~     to be a large gap in our understanding of disease pathogenesis and mechanisms accounting for~     large variability in disease phenotype. Untargeted metabolomics is an ideal approach to~     uncover the metabolic basis of disease, as well as discover unique drug target opportunities~     aimed at these nodal metabolic drivers of disease. There are very limited data from~     metabolomics studies from plasma/serum and exhaled breath condensate that suggest certain~     metabolic pathways or metabolites might predict the presence and/or severity of COPD~     phenotypes.~      Here, the investigators hope to generate comprehensive, compartment specific (blood and lung)~     metabolite profiles that will be correlated with various clinical phenotypes of COPD, using a~     complementary approach of untargeted nuclear magnetic resonance (NMR) and liquid~     chromatography (LC)- mass spectroscopy (MS) -based metabolomics.~   "
19620|NCT03310164|"~     Increasing evidence have implied that microbiota from airway and gut might be involved in the~     pathogenesis of chronic obstructive pulmonary disease (COPD). However, the cross-talk between~     respiratory and gastrointestinal microbiome in COPD is still undetermined. The study is aimed~     to investigate the interaction between lung and gut flora, and their role in the process of~     COPD.~   "
19621|NCT03310151|"~     A distal radius fracture is a break at the wrist end of the long bone on the outside of the~     forearm. It is common, and can cause problems with stiffness, pain and use of the hand and~     arm for several months. This study is investigating whether imagined movements whilst in the~     plaster improve dexterity, reduce pain or improve movement when the plaster is removed. As~     this is a pilot study the aim is to test research and assessment procedure to guide further~     studies.~      Imagined movements involve imagining the wrist moving, without actually moving the wrist. It~     has been suggested that immobilisation, for example in plaster, can affect the part of the~     brain responsible for movement and sensation. It has also been suggested that imagined~     movement can reduce this impact.~      This study is investigating subjects over the age of 50 with relatively low impact trauma.~     Younger subjects and higher velocity injuries will be excluded as this introduces an unwanted~     variable. Likewise, any fractures requiring surgery, or subjects with pre-existing upper limb~     injury or deformity will be excluded.~      Patients will be invited to participate following their attendance at the local Accident and~     Emergency department in Newport, South Wales, or the minor injuries department at Ysbyty~     Ystrad Fawr Hospital, Ystrad Mynach. Sampling will run for approximately 2 months and all~     participants will be given standard exercises. All participants will attend an appointment at~     approximately 1 week and be randomised into treatment or control group. The treatment group~     will be taught imagined movements and be asked to perform these for 10 minutes, four times a~     day, the control group will continue with standard exercises.~      All subjects will attend again for assessment of dexterity, pain and movement after the~     plaster has been removed, (4-8 weeks dependent on team). This concludes the study.~   "
19622|NCT03310138|"~     The purpose of this study is to develop repetitive transcranial magnetic stimulation (rTMS)~     as a potential treatment for pain in individuals on prescription opioid medication.~     Repetitive TMS is a non-invasive technique that uses magnetic pulses to temporarily stimulate~     specific brain areas in awake people (without the need for surgery, anesthetic, or other~     invasive procedures). This study will test whether 10 days of rTMS over the prefrontal cortex~     can produce a reduction in perception of pain and the desire to use opiates. TMS has been~     approved by the FDA as an investigational tool as well a therapy for depression.~   "
19623|NCT03310125|"~     The prevention of perioperative atrial fibrillation has the potential to reduce mortality,~     stroke, and hospital stays in patients undergoing thoracic surgery. Data from cardiac surgery~     patients suggest that prevention of perioperative atrial fibrillation using an~     anti-inflammatory agent, such as colchicine, is feasible. The COP-AF trial will assess~     whether the administration of oral colchicine will reduce the incidence of perioperative~     atrial fibrillation in patients undergoing major thoracic surgery.~   "
19624|NCT03310112|"~     This project aims to contextualize delivery of mindfulness training to U.S. Army personnel,~     evaluate its effectiveness on measures of executive functions and psychological well-being,~     and determine best practices for its delivery.~   "
19625|NCT03310099|"~     The investigators hypothesize that a dietary intervention aimed at increasing unsaturated~     fatty acids (UFA) consumption is feasible and has the potential to improve cardiorespiratory~     fitness, metabolic flexibility and glucose tolerance in symptomatic obese heart failure with~     preserved ejection fraction (HFpEF) patients.~   "
23012|NCT03265730|"~     Diarrhea is one of the side effects of antibiotics. Antibiotic associated diarrhea can be~     encountered between two hours to two months after starting of antibiotics. The purpose of the~     study is to determine incidence,risk factors and severity of pediatric antibiotic associated~     diarrhea in Turkey.~   "
19626|NCT03310086|"~     This experimental study will evaluate the effect of corticision on accelerating the leveling~     and alignment of lower crowded incisors compared with the control untreated group using cone~     beam computed tomography.~      The study sample will consist of 26 patients with less than 6 mm crowding. The sample will be~     allocated randomly into two experimental groups.~      The brackets and passive SS wire will be applied with radiographic metal guides between each~     tooth to allow for accurate corticision site 2 mm below the gingival papilla and to prevent~     tooth roots injury. The dentoalveolar changes occurring after leveling and alignment of lower~     anterior teeth will be evaluated using CBCT radiographs, Frequency, degree of root~     resorption, and the incidence of bone dehiscence will be assessed in relation to initial~     situation.~   "
19627|NCT03310073|"~     This study is to assess protectivity following four doses of bOPV which given simultaneously~     with Pentabio® and 1 dose of IPV at the 4th visit~   "
19628|NCT03310060|"~     The purpose of this study is to conduct a prospective randomized controlled trial to~     investigate the blood-conservation effect of the topical hemostatic agents in patients~     receiving primary TKA procedures. The investigators will also observe if there is increased~     risk of blood transfusion rate by using topical hemostatic agents or not.~   "
19629|NCT03310047|"~     An interventional randomized controlled crossover trial, to illuminate if durations in nerve~     block durations are predictable within the same subject.~   "
19630|NCT03310034|"~     This research project aims to determine whether supplementing with a mixture of the~     NAD+-precursors NA, NAM, and tryptophan can stimulate skeletal muscle mitochondrial function~     in physically compromised, elderly humans. Outcomes are related to mitochondrial function,~     energy metabolism, and physical function will be investigated.~   "
19631|NCT03310021|"~     This is a single-center, randomized, double-blind, and placebo-controlled trial designed to:~     1) demonstrate the degree to which administered andexanet doses can reverse Factor Ten A~     (FXa)-inhibitor induced anticoagulation; and 2) evaluate the safety and PK/PD of andexanet in~     healthy Japanese subjects taking direct FXa inhibitors at therapeutic doses.~   "
19632|NCT03310008|"~     SHRINK (Standard cHemotherapy Regimen and Immunotherapy with NKR-2) is an open-label Phase I~     study to assess the safety and clinical activity of multiple administrations of autologous~     NKR-2 cells administered concurrently with a standard chemotherapy treatment (FOLFOX) in~     potentially resectable liver metastases from colorectal cancer.~      The trial will test three dose levels. At each dose, the patients will receive three~     successive administrations, two weeks apart, NKR-2 cells. The study will enroll up to 36~     patients (dose escalation and expansion phases).~   "
19633|NCT03309995|"~     A randomized parallel-group two arm superiority trial with an allocation ratio 1:1, both~     participants and investigators blinded.~      The zinc lozenge that will be used in the study is a commercial product available from the~     University Pharmacy, Helsinki, Finland. The product is classified as a medical device and~     it is not regulated according to the jurisdiction for medicines.~      Each lozenge contains 13 mg elemental zinc as zinc acetate. The instruction in the commercial~     package for common cold patients is to dissolve slowly 6 lozenges per day in their mouth,~     which totals to 78 mg/day of elemental zinc, at most for 5 days. The same instruction will be~     used in this trial.~      The University Pharmacy prepared 200 placebo lozenge packages so that the placebo lozenges~     contain sucrose octaacetate, and they are similar with the zinc lozenges in visual appearance~     and in taste. 200 packages of zinc lozenges will be used as the active intervention. The~     packages will contain 30 lozenges (6 lozenges/day × 5 days).~      The packages of lozenges will be distributed to the enrolled participants in November 2017.~     The participants will be instructed to keep the package readily available so that, when they~     catch the common cold, they will find the package and they can start to take the lozenges~     according to the instructions.~      The participants will be instructed to start taking zinc lozenges as soon as they start to~     suffer from the first symptoms of the common cold. The participants will be instructed to~     take 6 lozenges daily over the time awake, evenly distributed, allowing the lozenge to~     dissolve in the mouth as slowly as possible. The duration of intervention is for the maximum~     of 5 days. If the symptoms disappear before 5 days, the participant may stop the usage of the~     lozenges.~      There will be no limitations for other treatments that participants wish to use for treating~     their colds.~      Participants will be requested to respond to a web-based symptom questionnaire daily from the~     first day of the treatment to the recovery from the common cold, or to a maximum of 2 weeks.~   "
19634|NCT03309982|"~     This study will investigate the beneficial effects of supplementation with a plant polyphenol~     blend rich in anthocyanins on parameters of inflammation and metabolic responses following a~     challenge with a high-fat (HF) meal.~      The investigators will use a randomized crossover study to investigate the effects of: 1)~     placebo (control); 2) plant polyphenol blend rich in anthocyanins; on systemic inflammatory~     markers (endotoxemia, cytokines, NF-κB), glucose and lipid metabolic responses following~     consumption of a high-fat (HF) meal in healthy subjects. The high-fat meal (320 g) consists~     of English muffin bread, sausage, egg and cheese, obtained from US market and completed with~     palm fat. The total energy content of the high-fat meal is 1,026 Kcal with 70.5 g of fat~     (29.8 g of saturated fat), 270 mg of cholesterol, 65 g carbohydrate, 5.2 g sugar, and 33 g~     protein with a total of 62% energy originated from fat, 25% from carbohydrates and 13% from~     protein. The high-fat meal will be standard and it will not be adjusted for large and small~     participants.~   "
19635|NCT03309969|"~     The aim of this study is to compare intravascular ultrasound with venography in the diagnosis~     and treatment of iliac vein compression syndrome.~   "
19636|NCT03309956|"~     This prospective study aims to compare the diagnostic yield, or ability to detect an~     arrhythmia, of the traditional Holter monitor versus the novel Zio patch monitor in pediatric~     patients referred for ambulatory electrocardiographic (ECG) monitoring. Children will wear~     both devices simultaneously for 48 hours and the incidence of clinically significant~     arrhythmias will be compared.~   "
19637|NCT03309943|"~     The central objective of this project is to obtain proof-of-concept data demonstrating the~     effects of propranolol (a beta-adrenergic antagonist) on neurobiological responses to~     personal smoking environments and behavioral responses in a laboratory smoking behavior task.~     Human cigarette smokers (N = 50) will take photographs of locations where they do and do not~     smoke cigarettes. They will then be randomly assigned to receive either propranolol (40 mg)~     or placebo prior to completing: A) An MRI session assessing neural responses to personal~     smoking/non-smoking environments, standard smoking/non-smoking environments and proximal~     smoking/non-smoking cues; and B) A laboratory session examining smoking behavior in response~     to environmental cues.~   "
19638|NCT03309930|"~     The purpose of this two phase study is to evaluate comprehension by people with acquired~     brain injury. The phase 1 portion of the study will examine comprehension of narrative~     paragraphs under 3 conditions: (a) written text only, (b) auditory output only (i.e.,~     synthetic speech - David voice) or combined written text and auditory output. The phase 2~     portion of the study is to evaluate comprehension of sentences and paragraphs produced with~     computer generated (synthesized) speech and digitized natural speech after multiple~     exposures.~   "
19639|NCT03309917|"~     General anesthesia often reduces blood pressure whereby blood flow to the brain and other~     vital organs may become insufficient. Thus, medicine is often administered to maintain blood~     pressure but it is unclear at what level blood pressure should be aimed at during anesthesia.~      Thirty patients undergoing major abdominal surgery will be included. The study will start one~     hour after the start of surgery and lasts for approximately half an hour. The purpose of the~     study is to evaluate whether blood flow to the brain can be increased by maintaining blood~     pressure at a higher level than that used in clinical practice. In the study, MAP is adjusted~     to a high, moderate, and low level for a short time. The low level of blood pressure used in~     the study, corresponds to the level aimed at in clinical practice. The drug noradrenaline~     will be used to control blood pressure. Blood flow to the brain will be evaluated on the neck~     using ultrasound.~   "
19640|NCT03309904|"~     This study evaluates the preventive effect of a neuromuscular training program on injuries in~     youth floorball players. Half of participants will receive the training program, and half act~     as control and perform their usual training practices.~   "
19641|NCT03309891|"~     This is a randomized, open-label, active controlled, Phase 2 study designed to assess the~     safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of weekly and~     semi-monthly doses of GX-H9 in the treatment of Paediatric Growth Hormone Deficiency (PGHD)~     as compared to the standard of care daily rhGH treatment.~   "
19642|NCT03309878|"~     This randomized phase I/II trial studies the best dose and side effects of mogamulizumab in~     combination with pembrolizumab and to see how well they work in treating patients with~     lymphomas that have come back after a period of improvement or does not respond to treatment.~     Monoclonal antibodies, such as mogamulizumab and pembrolizumab, may interfere with the~     ability of cancer cells to grow and spread.~   "
19643|NCT03309865|"~     Research of fecal microflora and dysbiosis status in ulcerative colitis (UC) has shown its~     influential role on the disease pathogenesis. Vedolizumab, a humanized monoclonal antibody~     blocking the migration of leukocytes into inflamed intestinal tissue, has been shown to~     achieve remission in about half of active UC patients. Dietary intervention in UC patients~     has not been adequately studied. There is a significant clinical gap to achieve a higher~     efficacy and better clinical outcomes on the treatment of active UC patients. This study~     proposes to assess the integrated effect of normalization of intestinal dysbiosis through a~     structured semi-vegetarian dietary intervention in active UC patients who will also be under~     the standard of care medical therapy (vedolizumab).~      Significance of investigation for innovation: The pathogenesis of UC has been found to be~     multi-factorial, including host genetics and dysregulated inflammatory response, and recent~     research has shown the influential role of gut environmental factors - dysbiosis which has~     been found the key feature of UC. Vedolizumab has been shown effective (e.g. 47% clinical~     response rate vs. 25% in placebo group) and is part of the current standard of care treatment~     in UC. With the observation of drastic increase of IBD patients in Asia, in which has~     historically low incidence of IBD, it is generally accepted that the westernized diet and~     urbanization of life style play an important role in IBD pathogenesis. Enteral nutritional~     therapy has been demonstrated effective in pediatric Crohn's disease (CD) patients; however,~     the application to adult IBD patients has not been widely accepted partly because of the~     compliance issue. In addition, unlike CD, neither enteral nutrition nor non-enteral nutrition~     in patients with active UC has been adequately studied. Therefore, this study proposes a~     novel approach to assess the integrated effect of a structured dietary intervention in active~     UC patients who will also be under the current standard of care medical therapy~     (vedolizumab). After this study achieves the proposed primary or secondary outcome, it will~     further support the hypothesized synergistic interactive therapeutic effect between the~     normalization of dysbiosis in the intestine (through dietary intervention) and~     anti-inflammatory biologics (vedolizumab).~   "
19644|NCT03309852|"~     The right side of the heart of often overlooked in patients who are acutely unwell, as the~     main area of focus when performing echocardiography tends to be the left ventricle. The right~     ventricle can yield important diagnostic clues that can aid the clinician, particularly in~     cases where one may suspect elevated right sided pressures, such as those due to a pulmonary~     embolus. Although it is taught that a dilated right ventricle is associated in patients with~     pulmonary embolus, but in patients with spontaneous circulation. What is unknown is patients~     who sustain a cardiac arrest, does the same hold true. There is a paucity of literature~     surrounding the appearance of the right ventricle in the cardiac arrest patient acutely. This~     study aims to assess right ventricular size and function in the immediate post cardiac arrest~     phase.~   "
19645|NCT03309839|"~     The purpose of this study is to determine how monocyte HLA-DR and other markers of immune~     function change with time in neonates who underwent cardiac surgery with cardiopulmonary~     bypasss.~      We hypothesize that HLA-DR expression in neonates is predictive of septic complications after~     cardiopulmonary bypass~   "
19646|NCT03309826|"~     The purpose of this study is to conduct a pilot randomized, controlled trial to evaluate the~     feasibility and obtain pilot outcome data for a subsequent definitive trial evaluating the~     effects of postitive airway pressure (PAP) treatment of obstructive sleep-disordered~     breathing (OSDB) on blood pressure control and maternal and fetal outcomes in hypertensive~     disorders of pregnancy. The primary aim of the pilot study is to assess feasibility measured~     as the rates of subject recruitment, adequate (>4h/night) PAP adherence (primary outcome~     measure) and protocol completion. Secondary aims will be to obtain preliminary data on the~     effects of PAP on maternal blood pressure, complications of hypertension, arterial stiffness~     and vascular biomarkers, course of labor and delivery and fetal outcomes including growth~     restriction, prematurity, and neonatal distress.~   "
19647|NCT03309813|"~     The goal of this prospective, randomized, sham-controlled, crossover study is to evaluate the~     safety and feasibility of ExAblate Neuro treatment of chronic trigeminal neuropathic pain.~   "
19648|NCT03309800|"~     A Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel, Phase II Clinical~     Trial to Evaluate the Efficacy and Safety of HL301 versus Placebo in acute bronchitis~     patients.~      Endpoint: BSS, The improvement and improvement rate of the tester for the treatment response,~     The satisfaction of the subject, Total usage of Acetaminophen~   "
19659|NCT03309657|"~     Ceftolozane/tazobactam is an emerging newly available antibiotic that has a broad spectrum of~     activity, and could be potentially useful in the management of central nervous system~     infections. However, data relating to penetration of ceftolozane/ tazobactam into the central~     nervous system, where a barrier against drug distribution exists (i.e. blood brain barrier),~     is currently limited. In critically ill patients this is all the more challenging as~     achieving adequate antibiotic concentrations even in blood is difficult.~      The aim of this study is to describe the concentrations achieved in the cerebrospinal fluid~     (i.e. bodily fluid found surrounding and inside of the brain) and blood after a single dose~     of ceftolozane/tazobactam administered in critically ill patients with an existing external~     ventricular drain (i.e. a device used in neurosurgery that relieves elevated intracranial~     pressure in the brain). It is planned that this information gained will help develop dosing~     strategies that will achieve target concentrations that will successfully treat central~     nervous system infections in the future.~   "
19649|NCT03309787|"~     The national epidemic of obesity is associated with considerable morbidity, disability and~     early mortality.~      Conventional weight loss programs beyond a primary care setting have the potential to reduce~     weight, but are difficult to access for adults with obesity in rural areas due to lack of~     transportation and access to specialty care. Routine intensive behavioral therapy, while~     effective, is often not supplemented with adjuncts that could be helpful in engaging~     participants in behavioral change. The overarching goal of this SYNERGY pilot project is to~     overcome barriers rural adults face by using video-conferencing to deliver specialty obesity~     care that otherwise is inaccessible to most adults faced with this disease. It also intends~     to use emerging mobile health (mHealth) technology which has shown considerable promise in~     providing motivational feedback. This proposal highlights T3/T4 translation bridging~     technologists, allied health staff, and clinicians in the development and implementation of~     new therapeutic modalities. The study aims to evaluate a telehealth-based health coaching~     program that is embedded in the Dartmouth-Hitchcock Weight and Wellness Center that~     integrates novel remote monitoring technology in effecting behavioral change using Amulet, a~     Dartmouth Computer Science developed mHealth device over a 16-week period. First, the~     feasibility and accessibility of an eHealth-delivered health coaching obesity intervention~     using remote monitoring and video-conferencing (Aim 1) will be evaluated. The potential~     effectiveness of achieving the primary outcome of 5% weight loss, with secondary outcomes of~     improved physical function and self reported health (Aim 2) will be ascertained. The~     intervention's impact on implementation outcomes of workflow, adoption, and organizational~     change that could affect further scalability and generalizability in other high-risk~     population groups (Aim 3) will be assessed. These preliminary findings will be used in a~     future competitive application for an extramural R01 designed to assess the effectiveness of~     our intervention in achieving weight loss in rural obese adults. If successful, this~     application has the potential to redesign care using applied methods of telehealth translated~     to community-based, rural populations to facilitate behavioral change. The project also meets~     criteria of the NIH Strategic Plan for Obesity and the Institute of Medicine's need for~     Telehealth research.~   "
19650|NCT03309774|"~     Complex regional pain syndrome (CRPS) is a disease provoking chronic pain in the limbs,~     following a trauma. Patient care is complicated by the variable clinical picture and response~     to treatment. The stress level of the organization, for chronic pain impacts the regulation~     of the autonomic balance. The study of time and frequency domain analysis of Heart Rate~     Variability (HRV) allows non-invasive and reproducible assessment of the autonomic balance.~   "
19651|NCT03309761|"~     The aim of the study is to describe an immune activation profile of people at risk of insulin~     resistance based on a wide range of markers which will allow easy identification of patients~     at risk.~   "
19652|NCT03309748|"~     This study investigates the remediation of black-stained tooth surfaces using antimicrobial~     photodynamic therapy. In this crossover trial, a cohort of patients received standard dental~     prophylactic cleaning to remove the black stain. Later, following the washout period,~     (reappearance of the black stain) received photodynamic therapy in addition to the standard~     cleaning. Stain-free period in each of the arms was the main outcome variable. Additional~     microbial plaque testing was also carried out.~   "
19653|NCT03309735|"~     Study the efficacy and safety of therapy for threatened miscarriage with medicinal products~     Utrogestan (micronized progesterone), 200 mg capsules (Besins Healthcare SA, Belgium), and~     Duphaston (Dydrogesterone), 10 mg coated tablets (Abbott Healthcare Products B.V., the~     Netherlands)~   "
19654|NCT03309722|"~     Molecular pathology of Colorectal Cancer: Investigating the role of novel molecular profiles,~     microRNA's and their targets in Colorectal Cancer progression~   "
19655|NCT03309709|"~     This prospective randomized study will compare the regression rates of women managed with~     watch-and-wait approach and of those treated with 3 cycles of luteal 25mg subcutaneous~     progesterone from 18 to 25 days of menstrual cycle~   "
19656|NCT03309696|"~     This device-study includes a pilot, physiological investigation of normal human subjects. The~     aim is to determine how existing non-invasive neuromodulation devices affect brain circuitry~     as measured by EEG recording. Currently, the application of non-invasive neuromodulation is~     rarely guided by detailed knowledge of how neural activity is altered in the brain circuits~     that are targeted for intervention. This gap in knowledge is problematic for interpreting~     response variability, which is common. To address this gap, the current proposal aims to~     combine two forms of neuromodulation sequentially, transcranial direct current stimulation~     (tDCS) and repetitive transcranial magnetic stimulation (rTMS), to regulate homeostatic~     plasticity prior to rTMS delivery at different frequencies of rTMS. Homeostatic plasticity,~     the initial activation state of a targeted circuit, is a key determinant of whether rTMS~     induces long term potentiation (LTP) or long term depression (LTD) Yet, homeostatic~     plasticity is rarely measured or controlled in rTMS studies. We aim to control homeostatic~     plasticity by preconditioning the targeted circuits with tDCS prior to rTMS delivery. The~     protocol also includes an exploratory aim to examine physiological changes in patients with~     tinnitus who only receive active stimulation, however, the exploratory aim is not part of the~     pilot physiological investigation.~   "
19657|NCT03309683|"~     Study design: A national, multi-center, patient-blinded, randomized clinical trial.~      Study population: Patients undergoing EMR with a moderate to severe risk (right sided colon,~     ≥2cm) of developing Delayed Bleeding (DB).~      Intervention: PC will be compared to standard care (no PC).~      Main study endpoints: Primary endpoint is the incidence of DB. Secondary endpoints are~     cost-effectiveness, quality of life and (severe) adverse events related to PC, adenoma~     recurrence and risk factors for DB.~   "
19658|NCT03309670|"~     The emergence of adult psychic disorders occurs in about three quarters of cases before 25~     years. The Pass-Aje service of Clermont-Ferrand University Hospital is a psychiatric unit~     specializing in the management of disorders of young adults. This unit evaluates the first~     episodes among the diversity of the clinical presentations of the psychic disorders. Suicidal~     attempts or ideations account for a large part of the reasons for entering the unit and are~     found transversely in many disorders. Among the reasons for hospitalization are a wide~     variety of situations that are not initially associated with an accurate diagnosis such as~     withdrawal, de-schooling, runaways, behavioral disorders (disorders of social interactions,~     self and hetero aggression, eating disorders).~      Investigator propose to study the psychiatric outcome of hospitalized patients in the~     Pass-Aje unit and their psychosocial evolution in order to compare them with the data of the~     general population and to identify the factors influencing their future.~   "
19660|NCT03309644|"~     This retrospective, population-based cohort study will evaluate the comparative effectiveness~     of peripheral nerve blocks on patient outcomes after ambulatory shoulder surgery in adults~     patients undergoing surgery in Ottawa, Ontario.~   "
19749|NCT03308474|"~     The purpose of the project is to set up a national, prospective, longitudinal, multicenter~     cohort study with associated satellites, a tumor registry platform, to document uniform data~     on characteristics, molecular diagnostics, treatment and course of disease, to collect~     patient-reported outcomes and to establish a decentralized biobank for patients with Multiple~     Myeloma in Germany.~   "
19661|NCT03309631|"~     A clinical trial is proposed, to clinically validate, in a US population, the diagnostic~     performance of a new genetic test (ThyroidPrint). It will determine the nature of thyroid~     nodules that have been informed as indeterminate by cytology through a fine needle aspiration~     (FNA). The Genetic Classifier for Indeterminate Thyroid Nodules is a test that determines the~     expression of a panel of 10 biomarkers (CXCR3, CCR3, CXCl10, CK19, TIMP1, CLDN1, CAR, XB130,~     HO-1 and CCR7). Gene expression data is analyzed through an algorithm that generates a~     composite score that predicts the risk of malignancy. It´s intended use is for patients with~     thyroid cytology as indeterminate (Bethesda III and IV, according to The Bethesda System for~     Reporting Thyroid Cytopathology). This test uses a fine needle aspiration (FNA) sample.~   "
19662|NCT03309618|"~     The concept of improving arterial wall characteristics by treatment with a very low-dose~     combination of fluvastatin and valsartan (low-flu/val) in stable, post-myocardial infarction~     (MI) patients was tested. The parameters of endothelial function (flow mediated dilatation~     (FMD), reactive hyperemia index) and arterial stiffness (carotid-femoral pulse wave velocity~     (cf-PWV), local carotid PWV and β-stiffness coefficient) were measured before and after 30~     days of treatment, and the residual effect was assessed 10 weeks later. So the investigators~     explored whether low-flu/val added on-top-of optimal therapy could improve endothelial~     function and arterial stiffness in post-MI patients. Since these improved parameters are~     well-known predictors of future coronary events, such treatment could decrease cardiovascular~     risk.~   "
19663|NCT03309605|"~     Phase 1 Multiple Ascending Dose Study in Normal Healthy Volunteers~   "
19664|NCT03309592|"~     The purpose of this study is to evaluate the efficacy and safety of the combination of~     ambrisentan and tadalafil in reducing mPAP to below 35mmHg in patients with moderate to~     severe Portopulmonary Hypertension (POPH) as a means to candidacy for liver transplantation.~   "
19665|NCT03309579|"~     The SAHaRA trial will clarify the role of treating anemia with Red Blood Cell (RBC)~     transfusion in a unique and vulnerable patient population, and determine whether that impacts~     on functional outcomes and mortality. It will guide best practice standards and clarify the~     optimal RBC transfusion strategy in patients with aSAH.~   "
19666|NCT03309566|"~     Bioequivalence study of two formulations containing a fixed dose combination of 600 mg~     Efavirenz, 200 mg Emtricitabine and 300 mg Tenofovir Disproxyl Fumarate in coated tablets~     under a single-dose, two-way crossover design.~   "
19667|NCT03309553|"~     Hearing loss is a common health problem in Alaska. Up to 75% of children growing up in~     Alaskan villages experience frequent ear infections, one of the major treatable causes of~     hearing loss. Children with even mild hearing loss face many challenges. These children often~     experience speech and language delays and have trouble in school. Teens with hearing loss are~     more likely to drop out of school, and are at risk for having difficulty finding jobs as~     adults. Promptly diagnosing and treating hearing loss is important for preventing these~     consequences. Alaska mandates school-based hearing screening, but many children with hearing~     loss are not identified by the current screening protocol, and most who are referred never~     make it into the healthcare system for diagnosis and treatment.~      Alaska has already developed innovative strategies to address hearing loss. A network of~     village health clinics staffed by community health aides provide local care, and telemedicine~     has been adopted in over 250 village clinics statewide. Despite being widely available,~     telemedicine has not yet been used in school hearing screenings to speed up the referral~     process.~      Norton Sound Health Corporation has partnered with Duke and Johns Hopkins Universities to~     explore whether a new school screening and referral process that incorporates mobile, or~     mHealth, screening and telemedicine referral will reduce childhood hearing loss disparities~     in the Norton Sound region. Children from kindergarten through 12th grade in 15 Norton Sound~     villages will receive the current school screening protocol and the new mHealth screen.~     Villages will then be randomized to continue the current primary care referral process or to~     adopt telemedicine referral for school screenings. The investigators hypothesize that the new~     mHealth screening protocol will identify more children with hearing loss, and telemedicine~     referral will reduce time to diagnosis. By better identifying hearing loss and speeding up~     diagnosis and treatment, the investigators expect the burden of childhood hearing loss to~     drop, hearing-related quality of life to improve, and school performance to improve in~     villages with telemedicine referral compared to current primary care referral villages. If~     the study shows these positive effects, mHealth screening and the telemedicine referral~     process could be implemented in school districts across the state of Alaska to reducing~     childhood hearing loss disparities statewide.~   "
19668|NCT03309540|"~     The purpose of this study is to investigate the effect on QoL, PI and the AROM° in patients~     with non-specific chronic low back pain. This after following an episode of 6 weeks 2 times a~     week physiotherapeutic back rehabilitation according to the 4 times T method by orthopaedic~     disorder ® (4MTOR®). The results in this research will be analyzed and reported. In this~     study, 7 dependent variables will be independently examined relative to 2 independent~     variables.~   "
19669|NCT03309527|"~     In the past, there were studies on relationship between insomnia and depression, and those~     studies found that depression can be the result of untreated insomnia. Mostly insomnia~     precedes depression, and is a marker for recurrence of depression. Research suggests that~     insomnia may cause depression by changing the emotional response.~      In this study, investigators will establish the national online cognitive behavioral therapy~     for insomnia (e-aid Cognitive Behavioral Therapy for Insomnia, eCBTI ) tools, and online~     health education on sleep (e-aid Sleep Hygiene Education, eSHE ) tools for controls.~     Investigators will be testing whether eCBTI can reduce the incidence of depression in~     patients with sleep disorders, increasing remission rate of depression, and a corresponding~     reduction in suicidal ideas, compared with eSHE control groups.~   "
19670|NCT03309514|"~     This is a prospective study to demonstrate the safety and efficacy of differentiated~     neurons-derived from adult CNS progenitors cells transplanted in selected patients with~     Parkinson's disease.~   "
19671|NCT03309501|"~     Knee osteoarthritis(OA), also known as degenerative arthritis, have affected a lot of people.~     Patients with severe osteoarthritis frequently develop one or more of the typically following~     symptoms: joint pain, stiffness, activity with joint friction noise, limited mobility, such~     as difficulty walking and climbing. Now there are many western medicine treatments including~     symptom relief and joint cartilage protective agents for OA, but the results have not yet~     satisfied. TCM treatment of osteoarthritis has remarkable curative effect and unique~     advantage.Tong-Luo-Qu-Tong Plaster is a common method to treat osteoarthritis of the knee for~     thousands of years in China. It lacked a large sample randomised, double-blind, parallel~     positive controlled, multicenter clinical trial, and the clinical evidence of~     Tong-Luo-Qu-Tong Plaster for Knee Osteoarthritis need to be further completed.~   "
19689|NCT03309267|"~     Pain after thoracotomy is the most severe pain experienced by the patient. Good pain control~     after the operation provides comfortable respiration and reduces the development of chronic~     pain and complications.~      we aimed to compare SAPB with IBregarding postoperative visual analog scale (VAS) scores and~     analgesic consumption in patients undergoing thoracotomy operation.~   "
19690|NCT03309254|"~     This study aims to demonstrate the effectiveness of increased protein ingestion, particularly~     when coupled with a low glycaemic index (GI) to reduce biomarkers related to high risk of~     diabetes.~   "
19672|NCT03309488|"~     The BAT II Study is a cross-sectional diagnostic study in which children with suspected~     IgE-mediated allergy to foods (namely cow's milk, egg, sesame and cashew), as defined by a~     history of an immediate-type allergic reaction to a food or no history of food consumption or~     the presence of food-specific IgE as documented by skin prick test or serum specific IgE,~     will undergo a diagnostic work-up to confirm or refute the diagnosis of IgE-mediated food~     allergy. Participants will be prospectively recruited from specialised Paediatric Allergy~     clinics in London and will undergo skin prick testing (SPT), specific IgE testing to allergen~     extracts and allergen components, basophil activation test (BAT) and oral food challenge. The~     diagnostic accuracy of the BAT and of other allergy tests will be assessed against the~     clinical gold-standard.~   "
19673|NCT03309475|"~     The current investigation aims to compare two group intervention in patients with a first~     episode of psychosis, that is, people who have suffered their first psychotic episode within~     5 years prior to their inclusion in the study. The experimental arm is a mindfulness-based~     social cognition training (SocialMind) designed by professionals with both formal training~     and clinical experience in the field of mindfulness and third generation cognitive-behavioral~     therapies. The active comparator arm is a psychoeducation program specifically designed for~     individuals with recent onset psychosis by members of the team with great experience in~     delivering such interventions. The main outcome is social functioning, as measured by the~     Personal and Social Performance Scale (PSP), an instrument developed for psychotic patients.~     The main hypothesis is that the improvement in social functioning will be larger among the~     participants on the experimental arm, because there is enough evidence suggesting that~     deficits in social cognition are present even in the first stages of psychotic syndrome and~     related to social functioning and general disability. Moreover, mindfulness-based~     interventions have proven themselves effective in other severe mental disorders.~   "
19674|NCT03309462|"~     The objective of the study is to reveal the acquired resistance mechanism of the first and~     second generation Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor (EGFR-TKI) in~     tissue and plasma using Next Generation Sequencing (NGS) and the difference of ctDNA in~     plasma and DNA in biopsy samples is compared and the consistency of two samples was observed.~     At the same time, the sensitivity, specificity and the consistency of detecting T790M~     mutation using ddPCR, Cobas and NGS were compared.~   "
19675|NCT03309449|"~     This will be a usability trial to assess administration of naloxone via intramuscular,~     atomized intranasal, and nasal spray routes by nonmedical community members. Participants~     will undergo blocked randomization to naloxone kits containing supplies for one of the~     aforementioned routes and view an instructional video on how to appropriately administer the~     kit they were assigned. Participants will then have the opportunity to administer the~     simulated drug to a mannequin designated to simulate the route of administration assigned to~     the participant. The rate of successful administration will be determined for each route.~   "
19676|NCT03309436|"~     Clomiphene citrate has been widely used for treatment of infertility for decades. Although~     its anti-estrogenic effects leads to low pregnancy rate, clomiphene citrate is still a~     first-line treatment for ovulation induction because of its simple usage, low prices, no~     injection and low risk of ovarian hyperstimulation syndrome. Clomiphene citrate shows high~     affinity with estrogen receptor, which inhibits endometrial proliferation, inevitably leads~     to a decline in endometrial receptivity, thus affecting the success rate of IVF.~      In that case, use clomiphene citrate for ovulation induction is lost more than gained based~     on fresh embryo transfer. But recently, some researchers have proposed to extend the time~     from ovulation induction to embryo transfer, and the increased level of estradiol can replace~     clomiphene citrate to combine with the receptor, so that the uterine environment is more~     conducive to pregnancy. Therefore, use clomiphene citrate based on vitrification of embryo~     maybe a good way for treatment of infertility.~      At present, using frozen embryo transplantation after ovulation induction by clomiphene~     citrate is a common treatment, but few research has mentioned the best time for embryo~     implantation. The investigators research is to find the most appropriate time for frozen~     embryo implantation after using clomiphene citrate for ovulation induction.~   "
19677|NCT03309423|"~     Objective: Arterial blood gas (ABG) is essential in the clinical assessment of potential~     acutely ill patients venous to arterial conversion (v-TAC), a mathematical method, has~     recently been developed to convert peripheral venous blood gas (VBG) values to arterialized~     VBG (aVBG) values. The aim of this study is to test the reliability of aVBG compared to ABG~     in an intensive care unit (ICU) setting.~      Method: Consecutive patients admitted to the ICU with pH values <7,35 or >7,45 are included~     in this study. Paired ABG and aVBG samples are drawn from patients via arterial catheter,~     central venous catheter and/or peripheral venous catheter and compared.~   "
19678|NCT03309410|"~     Objective: Arterial blood gas (ABG) analysis is essential in the clinical assessment of~     potential acutely ill patients. Venous to arterial conversion (v-TAC), a mathematical method,~     has recently been developed to convert peripheral venous blood gas (VBG) values to~     arterialized VBG (aVBG) values. The aim of this study was to test the reliability of aVBG~     compared to ABG in an emergency department (ED) setting.~      Method: Twenty ED patients were included in this study. ABG and three aVBG samples were~     collected from each patient. The aVBG samples were processed in three different ways for~     comparison: aVBG1 was held steady and analysed within 5 minutes; aVBG2 was tilted in 5~     minutes and analysed within 7 minutes; aVBG3 was held steady and analysed after 15 minutes.~     All VBG samples were arterialized using the v-TAC method. ABG and aVBG samples were compared~     using Lin's Concordance Correlation Coefficient (CCC) and Bland-Altman's analysis.~   "
19691|NCT03309241|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of~     single oral doses of PF-06882961 in healthy adult subjects. This is the first clinical study~     of PF-06882961.~   "
19692|NCT03309228|"~     The DOSAGE Study is a qualitative transversal study aiming to describe and understand the~     subjective factors of polymedication in the elderly population (75 years old and more),~     defined as 10 simultaneous drugs. Semi-structured interviews will be conducted with patients,~     relatives and general practitioners in one French region. 20 situations will be included.~     After analysing the data of the individual interviews, focus groups will be conducted with~     health professionals.~   "
28605|NCT03192579|"~     This study aim to evaluate whether intensive lipid lowering therapy may improve the clinical~     outcomes in coronary artery disease patients with in-stent neoatherosclerosis, in comparison~     with standard therapy.~   "
19679|NCT03309397|"~     Physical activity and sport are beneficial to the cardiovascular system, the musculoskeletal~     system and many chronic pathologies. The High Authority of Health (HAS) recommends a regular~     practice. However, depending on the discipline and level of practice, it may be responsible~     for traumatic injuries, degenerative musculoskeletal injuries, overtraining, eating disorders~     or cardiovascular events. It also promotes urinary stress incontinence, by increasing~     intra-abdominal pressure in some situations.~      The prevalence of urinary leakage in the athlete depends of the practiced physical activity.~     A classification of the sports activities can be carried out according to the risk of~     increased pressures on the pelvic floor:~        -  high-risk sports: trampoline (10.17), acrobatic gymnastics, aerobics, athletics (jumping~          hedges, heights, triple jump), horse riding, basketball, volleyball, handball, martial~          arts;~        -  moderate-risk sports: tennis, skiing ...~        -  low risk sports: walking, swimming, cycling, rollerblading, golf ... In sports, urinary~          incontinence also depends of the practiced movements (jumps, abdominal exercises ...),~          and the occurence of sports activity. This disorder has even become one of the concerns~          of federal sports authority (INSEP).~      However, there is no data regarding stress incontinence of sports teenagers found n the~     literature on~   "
19680|NCT03309384|"~     The goal of this study is to evaluate the role of intraoperative continous and intermittent~     neuromonitoring and intraoperative parathormone (PTH) to predict postoperative nerve~     morbidity and hypocalcemia.~   "
19681|NCT03309371|"~     Lumbar disc herniation is the most important and frequent affection in rheumatology. The~     first treatment is based on an non-steroidal anti-inflammatory drugs.Physiotherapy also is~     used.But when there is no efficient result, it's usual to propose to the patient corticoid~     injection, percutaneous intervention or arthrodesis.~      Recently DISCOGEL® is a medical device used for lumbar disc herniation. However there is no~     studies evaluating the benefit and the efficiency of this technic. Since a few years, the~     rheumatology service of GHPSJ practise this technic using DISCOGEL® with patient resistant to~     the medical treatment . So the aim is to evaluate the benefit of DISCOGEL® retrospectively.~   "
19682|NCT03309358|"~     Although Cystic Fibrosis is a complex genetic disease affecting many organs, lung disease is~     the primary cause of mortality. The objective of this study is to determine the safety and~     tolerability of SNSP113 in healthy subjects and subjects with stable cystic fibrosis.~   "
19683|NCT03309345|"~     This will be case-control study investigating whether dietary intake and components of energy~     expenditure such as Basal metabolic rate (BMR), physical activity energy expenditure (PAEE)~     and diet induce thermogenesis (DIT) are different between people with phenylketonuria (PKU)~     and matched healthy controls. Participants will be children and adults with PKU age between~     10 to 45 years old, free from history of any acute and chronic illness. Participants will~     attend the Metabolic Research Unit at New Lister Building (NLB) after 12-hour overnight~     fasting refraining from alcohol consumption for at least 24 hours. Any planned exercise will~     be avoided during the 48 hours prior visit to the Metabolic Research Unit. Height, body~     weight and handgrip strength will be measured upon arrival at the unit. BMR will be assessed~     and participants will be asked to provide baseline saliva sample followed by consumption of 8~     g deuterium water (D2O) diluted in drinking water. Normal or PKU-type isocaloric breakfast~     meal will then be provided based on intervention group-type. DIT will be measured 5 times for~     3 hours, with each measurement lasting for 20 minutes. Two saliva samples will be collected~     at 3 and 3.5 hours after ingestion of D2O. Participants will be asked to perform an~     incremental intensity exercise test for 20 minutes on the treadmill during which expired air~     will be collected and accelerometer counts and heart rate will be measured. Participants will~     then be trained on how to recorded food intake and how to use accelerometers for habitual~     physical activity measurements. PKU participants (and their parents if ≤15 years old) will be~     asked to complete quality of life (QoL) questionnaires. Participants will be required to wear~     the accelerometer equipment for seven consecutive days excluding bedtime and keep a record of~     non-wear times. During these days, they will also prospectively record estimated food and~     beverages intake over four days including one weekend day.~   "
19684|NCT03309332|"~     The purpose of this single arm, multi-center study is to confirm the safety and effectiveness~     of the AMPLATZER™ PFO Occluder in the post Approval Setting.~   "
19685|NCT03309319|"~     Growth hormone secreting pituitary adenomas(GHomas) produce excessive GH, stimulating~     excessive insulin like growth factor 1(IGF-1) synthesis in the liver, thus causing multiple~     systemic complications. The life expectancy of patients with untreated GHomas is shortened by~     ten years. The treatment goal of GHomas is to shrink the tumor volume and normalize GH and~     IGF-1. Under current treatment, only 50-70% of patients get remission. Rosiglitazone is a~     widely used oral antidiabetic medicine. The investigator's preliminary data showed that~     rosiglitazone decreased the synthesis of GH and IGF-1 in rat pituitary tumor cells GH3 and~     hepatocytes respectively. The investigator plan to investigate the efficacy of rosiglitazone~     in the treatment of patients with GHomas who have not been alleviated by other therapies.~   "
19686|NCT03309306|"~     The purpose of this study is to test the use of a smartphone app as a way to measure food~     waste.~      Investigators propose to improve the accuracy and convenience of household food waste~     measurement so that consumer food waste program evaluations yield more power, less bias, less~     measurement error, and greater representation of targeted populations.~   "
19687|NCT03309293|"~     the investigators hypothesize that some of these polymorphisms contribute to VTE risk in~     women using COC, and that their screening could to help assess individual risk of VTE before~     COC prescription.~      In order to test this hypothesis the investigators propose to build a predictive score for~     VTE in women using COC based on clinical and biological factors. To this end the~     investigators have a large case study (including 766 patients) recruited at the Centre~     d'Exploration des Pathologies Hémorragiques et Thrombotiques (CEHT) of the laboratory of~     Hematology (La Timone Hospital, Marseille) between 2003 and 2013. The cases had a personal~     history of documented VTE while using COC (PILGRIM study). A great number of clinical and~     biological relevant phenotypes in the field of VTE have already been collected (including 14~     polymorphisms selected on the basis of their biological plausibility and the existence~     association studies).To our knowledge it is the largest study specifically conducted in order~     to assess genetic factors associated with VTE in women using COC. These 766 cases will be~     compared to 766 controls from the general population (cohort Nutrinet-Santé). Then, the~     predictive values of the score will be assessed in an independent multicentric validation~     study that the investigators will set up in the field of this project. Our study should allow~     a better understanding of the genetic and environmental factors involved in VTE related to~     COC use. Besides, this project aims to respond to a major public health issue giving an~     effective tool for the decision of prescribing COC.~   "
19688|NCT03309280|"~     The aim of this study is to determine which factors could be at risk of delayed extubation~     after cardiac surgery.~   "
19693|NCT03309215|"~     The former Nickel Directive was introduced in EU in 1994 limiting the release of nickel from~     items intended for prolonged contact with skin. The nickel regulation entered into full force~     in 2001 and became a part of REACH (the EU chemicals regulation) in 2009. Since then the~     prevalence of nickel allergy has declined in some countries, but not in others, following the~     implementation. Young individuals still become allergic to nickel (2, 3) and a high~     prevalence of nickel allergy, exceeding 10%, is seen among young women (below 30 years) in~     the general population.~      The EU nickel regulation has been changing over time. The present limits of nickel release~     for metallic items intended for direct and prolonged contact with the skin is <0.5~     μg/cm2/week and <0.2 μg/cm2/week for any post assemblies inserted into pierced holes. In~     2014, EU defined prolonged contact with the skin as: at least 30 minutes on one or more~     occasions within two weeks for items with continuous skin contact, or to at least 10 minutes~     on three or more occasions within two weeks (7).~      The overall objective is to evaluate how well the EU nickel regulation protects individuals~     against developing nickel dermatitis. More specifically we will:~        1. Study the penetration of nickel in normal and irritated skin after short repeated skin~          exposure under controlled temperature in nickel sensitized patients and in healthy~          controls~        2. Reveal the potential of short repeated nickel skin exposure on normal and irritated skin~          to elicit dermatitis, during controlled climate factors in nickel sensitized patients~          and controls using the time restrictions of the definition of prolonged skin contact in~          the nickel regulation.~   "
19694|NCT03309202|"~     Hepatic impairment PK study~   "
19695|NCT03309189|"~     The aim of the present study is to assess the prevalence of overweight and obesity in 6 to 12~     year old children in Switzerland. This data will be used to investigate trends in the~     development of overweight and obesity in Switzerland. In addition, a questionnaire will be~     used to assess data on physical activity, nutrition, health and socioeconomic background and~     waist circumference as well as skin fold thicknesses will be measured.~   "
19696|NCT03309176|"~     Rationale:~      There is some information suggesting that a progesterone-induced withdrawal bleeding before~     the start of ovulation induction in women suffering from oligo- or amenorrhea reduces~     pregnancy and live birth rate.~      Objective:~      To evaluate the effects of withholding progesterone-induced endometrial withdrawal bleeding~     before ovulation induction on the time to pregnancy and the ongoing pregnancy rate.~      Study design:~      Prospective multicenter randomized controlled feasibility study~      Study population:~      Women with oligomenorrhea or amenorrhea according to WHO classification category 2~      Intervention:~      Patients will be randomized to receive one of the following two treatments:~      Stair step group: blind start ovulation induction (no progesterone induced withdrawal~     bleeding and stair step protocol in case of treatment failure.~      Control: standard care; a progesterone induced withdrawal bleeding in case of no spontaneous~     menses before starting an ovulation induction cycle and in between anovulatory cycles.~      Main study parameters/endpoints:~      The primary endpoints are the time to pregnancy and ongoing pregnancy rate within a treatment~     horizon of 3 cycles. Secondary endpoints include time to ovulation, endometrial thickness,~     multiple pregnancy and the incidence of treatment failure.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness:~      The number of site visits or physical examinations will not differ from accepted clinical~     practice.~   "
19697|NCT03309163|"~     The incidence of postpartum depression in Europe and the United States is about 10%, while in~     China the incidence rate of 15.7-39.8%. Postpartum depression is one of the most common~     diseases of perinatal distress, but the current research of high-quality prevention and~     treatment of postpartum depression is still very lack. The study suggests that the risk of~     postpartum depression in cesarean delivery is significantly higher than that in vaginal~     delivery. Therefore, postpartum depression in cesarean delivery may require more attention~     and treatment.Tramadol is a non-opioid central analgesic that relieves common to severe pain,~     and tramadol has an inhibitory effect on norepinephrine and serotonin systems and has the~     potential to reduce depression and anxiety. Therefore, for the analgesic demand and~     antidepressant demand for maternal who undergoing cesarean section, tramadol may be an~     optimized and effective analgesic for the prevention and treatment of postpartum depression.~   "
19698|NCT03309150|"~     The main purpose of the study is to monitor the safety of subject receiving long-term~     treatment of M6620 as monotherapy or in combination with carboplatin and paclitaxel.~   "
19699|NCT03309137|"~     Intravenous catheters are often placed in large (central) veins in critically ill patients to~     provide special medications or frequent blood sampling. The body reacts to the presence of~     foreign material by forming a biofilm on the surface within the catheter. Either due to the~     patients condition or to emergency access to these intravenous lines can become infected with~     bacteria and reside within the biofilm. When bacteria is grown from these lines it is~     referred to as: a central line infection. A medical device company (ICU Medical) has obtained~     the rights to a device that delivers a controlled amount of a cleaning material called~     chlorhexidine into the catheter to prevent bacterial growth when not in use. Chlorhexidine is~     the standard cleaning material used on patients when cleaning the skin for surgical~     procedures or central intravenous catheter insertion. In laboratory tests and animal studies~     that chlorhexidine inhibits the growth of bacteria and fungi that often cause central line~     infections. This study will the first assessment in patients with central lines.~   "
19700|NCT03309124|"~     The purpose of the present study is to explore the influence of cooking methods of potatoes~     on post-prandial glycaemia and satiety in healthy older adults.~   "
19701|NCT03309111|"~     The purpose of this study is to determine the safety profile and maximum tolerable dose (MTD)~     of single-agent GBR 1342 in subjects with multiple myeloma who have received prior therapies.~   "
19721|NCT03308851|"~     The primary objective of this research is to compare the rate of canine retraction following~     the osteoperforation and piezocorticision procedures in cases of first premolar extractions.~     The secondary objectives are to compare the second order movement of the canine (tipping),~     the amount of root resorption associated with the procedures, the inflammation process by~     measuring the inflammatory markers in the gingival crevicular fluid, the loss of posterior~     anchorage by measures on the cone beam computed tomography (CBCT) 3-dimensional radiograph~     and on the casts and to evaluate the pain level and the impact on quality of life following~     each procedure using the questionnaire of the visual analogue scale (VAS) of pain.~   "
19702|NCT03309098|"~     Ankle injuries, specifically lateral ankle sprains, are the most common acute injury to the~     active population (Hootman, Dick, & Agel, 2007). It is important to insure the use of best~     practice and ensure that the techniques being utilized in clinics for evaluation are~     validated and consistent within the techniques. Manual testing and instrumented testing have~     not yet been tested within the same cohort.~      The purpose of this study is to compare the diagnostic outcomes of a clinician and of a~     diagnostic arthrometer when testing acute ankle injuries. Participants will be recruited at~     University of Nebraska at Omahas (UNO) Injury Prevention and Care Clinic and Athletic~     Training Room in Sapp Fieldhouse. Participants with be members of the UNO Wellness Center or~     UNO athlete, aged 19-80 years old. During a standard evaluation the participant will have a~     clinician test manual ligamentous laxity and a blinded clinician testing laxity using an~     arthrometer. Participation will not alter the normal treatment or care for participants. The~     author hypothesizes that the diagnostic accuracy for all performed test will be good to~     excellent when assessed for laxity and moderate to good when assessed for pain.~   "
19703|NCT03309085|"~     This is a prospective single-center cohort trial to compare regional bronchial recruitment,~     bronchial distention and alveolar recruitment in 6 patients with acute respiratory distress~     syndrome (ARDS). The investigators used CT scan images as the imaging modality, and the~     subjects were scanned on end-expiratory lung volume with different positive end-expiratory~     pressures. Those images were post-processed to evaluate the airways.~   "
19704|NCT03309072|"~     The purpose of this study is to investigate whether we can accelerate learning and improve~     associative memory performance in healthy subjects by applying transcranial Direct Current~     Stimulation (tDCS) during a Face Name memory task.~   "
19705|NCT03309059|"~     In clinical practice, there are a large number of patients hospitalized with~     Incontinence-Associated Dermatitis. Studies are needed to determine the effectiveness of~     products available for disease prevention. It is believed that the use of the non-irritant~     barrier film is superior to the use of zinc oxide in the prevention of~     Incontinence-Associated Dermatitis. The objective of this study is to compare the effect of~     the use of zinc oxide ointment with the use of non-irritant barrier film in the prevention of~     diaper dermatitis in incontinent patients admitted to medical clinic units.~   "
19706|NCT03309046|"~     This randomized clinical trial will test a behavioral caregiving intervention that has been~     used successfully for dementia and spinal cord injury caregivers to provide services to~     stressed and burdened parent caregivers of post 9/11 service members/veterans. This~     intervention is six intensive individual sessions that will teach problem solving, cognitive~     restructuring and stress reduction targeted to an individual assessment of the care dyad's~     needs. It will be compared to another method of delivering content, education webinar~     sessions, which are analogous to the usual standard of care and will function as an attention~     control arm. The objective of the study is to determine which of these delivery mechanisms is~     more effective at helping parent caregivers of injured post 9/11 returning troops to improve~     their depression, anxiety, and burden, and to determine the feasibility of using individual~     sessions with this population of caregivers.~   "
19707|NCT03309033|"~     Background:~      HPV is the human papillomavirus. Women who get infected with it can get cervical cancer. The~     Costa Rica vaccine trial (CVT) studied an HPV vaccine for young women. A Long Term Follow Up~     (LTFU) study was done 10 years later. Researchers want to follow up with the women in these~     studies for 5 more years. This will help them learn more about the risks and benefits of the~     HPV vaccine.~      Objectives:~      To study anti-HPV-16/18 antibodies over the long term in women who got an HPV vaccinate. To~     study how antibody levels have changed depending on the dose and type of vaccine.~      Eligibility:~      Women in the original CVT LTFU study~      Design:~      Staff will contact participants from the CVT LTFU study. This will be done by phone or in~     person at home. Participants will be asked about participating in a new study.~      Participants who agree will have their first study visit and sign the informed consent~     document.~      Participants will answer questions about sexual behavior, smoking, contraceptives, and~     reproductive history.~      Participants will have blood collected.~      Study visits will be conducted either in a clinic or at home.~   "
19708|NCT03309020|"~     Objective: Zaire ebolavirus is a single-stranded RNA virus associated with high morbidity and~     mortality. The most recent epidemic of Ebola virus disease (EVD) in West Africa resulted in~     over 11,000 deaths and disabling sequelae among survivors, among which eye complications are~     highly represented. Chronic intraocular inflammation and viral persistence may result in~     posterior synechiae and cataract formation, resulting in loss of visual acuity and requiring~     surgical intervention to resolve. Approximately one out of ten Ebola survivors present with~     cataract, most of whom will require intraocular surgery during their lifetime, and many of~     whom require intervention in the near future to regain quality of life. For survivors who are~     blind from cataract, cataract extraction is necessary to restore visual function, allow~     reintegration into society and facilitate performance of activities of daily living.~      However, surgical parameters among Ebola survivors are unknown, including whether Ebola viral~     RNA persists in aqueous humor, whether additional anti-inflammatory medication is needed, and~     the expected degree of improvement in visual function. Moreover, sites of viral persistence~     are unknown, and it is unclear if lens tissues removed during cataract surgery may harbor~     virus in Ebola-affected eyes. We propose following EVD survivors and control subjects~     undergoing cataract surgery to determine visual outcomes among Ebola survivors and explore~     detection of the presence of virus in lens tissues. The data will inform both future surgical~     intervention and aid in the understanding of the pathophysiology of Ebola-associated eye~     disease.~      Study Population: Up to 60 Ebola survivors and up to 60 controls will be enrolled. The~     accrual ceiling is 120 participants.~      Design: This is a prospective, natural history study to evaluate the persistence of Ebola~     viral RNA in the eyes of Ebola survivors and assess the response to cataract surgery in~     survivors as compared to controls. EVD survivors will first undergo assessment of aqueous~     humor for the presence of viral RNA. Survivors testing negative for viral RNA and control~     subjects will undergo clinically indicated cataract surgery. Subjects will be evaluated 1~     day, 1 week, 1 month, 3 months, and 6 months after surgery for safety and visual outcome~     assessments, and more often as clinically indicated.~      Outcome Measures: The primary outcomes are: 1) the proportion of EVD survivors with evidence~     of persistence of Ebola viral RNA in ocular tissue and 2) the comparison of amount of~     intraocular inflammation, as measured by average grade of anterior chamber cell by SUN~     criteria, between EVD survivors and controls at 1 month and 3 months following cataract~     surgery. Secondary outcomes include: 1) the proportion of survivors with at least 20/40 best~     corrected visual acuity (BCVA) after cataract surgery, relative to controls; 2) significance~     of covariates, age and gender, in logistic regression assessment of viral persistence and~     cataract outcomes; 3) post-operative optical coherence tomography results in EVD survivors.~   "
19722|NCT03308838|"~     This observational case-control trial sought to identify and characterize different exposures~     associated with nonfatal acute myocardial infarction in Costa Rican adults. Exposures~     assessed included dietary variables and adipose tissue fatty acids.~   "
19723|NCT03308825|"~     This multicenter, open-label, Phase IV study was designed to describe the safety and~     immunogenicity of Fluzone Quadrivalent vaccine in children 6 months to < 9 years of age and~     adults 18 to < 65 years of age, and to describe the safety and immunogenicity of Fluzone~     High-Dose vaccine in adults ≥ 65 years of age.~   "
19709|NCT03309007|"~     The goal of this pilot and feasibility study is to investigate the effects of a short course~     of metformin therapy on a surrogate marker of cellular senescence and autophagy among adult~     patients with prediabetes. The overall hypothesis is that metformin will have beneficial~     effects on longevity and quality of life by inducing autophagy downstream of activating~     adenosine monophosphate-activated protein kinase (AMPK) and inhibiting mechanistic target of~     rapamycin (mTOR) through potential effects of reduced inflammation, reduced degeneration of~     muscle and tendon tissue, antineoplastic effects, reduced obesity and hyperglycemia,~     preserved cardiovascular functions, and/or the prevention of neurodegeneration (such as~     age-associated dementia). This pilot study will address the following aim:~      Demonstrate that metformin therapy will increase cellular autophagy as an inverse correlate~     of aging as measured by increases in Microtubule-associated protein 1A/1B-light chain 3 (LC3)~     scores.~      Hypothesis 1: In addition to beneficial effects on glycemia, body weight, and body~     composition, metformin therapy exerts beneficial effects on surrogate measures of autophagy~     and aging.~      Primary outcome: Increased levels of LC3 in leukocytes.~   "
19710|NCT03308994|"~     The study design matches with a multicenter observational ambispective study. A first pilot~     study will be undertaken in Caen center and is expected to be extended to Rouen and Lille~     center. So patients from Normandy and North-West areas will be included.~      In order to include patients in this observational study historical data about first line~     injectable treatments (interferons and glatiramer acetate) are used. As well as the data on~     patients treated with oral first line therapies (teriflunomide and dimethyl fumarate) began~     to be collected ahead of the study start (Retrospective phase). During the course of the~     study, new patients under teriflunomide or dimethyl fumarate will be included (Prospective~     phase).~   "
19711|NCT03308981|"~     This study aims to test the efficacy of the REThink therapeutic online video game. Children~     and adolescents (N = 150), aged between 10-16 years, will be randomly assigned to one of~     three groups: 1) REThink group, 2) Rational-Emotive-Behavioral Education (REBE) group and 3)~     wait-list condition.~   "
19712|NCT03308968|"~     The purpose of this study is to evaluate the efficacy, safety, and tolerability of monthly~     and quarterly subcutaneous (sc) injections of fremanezumab compared with sc injections of~     placebo in patients with chronic migraine (CM) or episodic migraine (EM) who have responded~     inadequately to 2 to 4 classes of prior preventive treatments.~      Approximately equal numbers of patients from each subgroup (CM and EM) are randomized in~     blinded-fashion 1:1:1 into one of three treatments for the subgroup - two active treatments~     and one placebo treatment --- consisting of monthly injections for 3 months (up to week 12).~     Then all participants continue into an open-label extension of 3 months (weeks 13-week 24)~     during which everyone is administered sc injections of fremanezumab.~   "
19713|NCT03308955|"~     Laparoscopy is frequently used today for intraabdominal operations. Laparoscopic procedure~     has become the treatment of choice for many patients with symptomatic cholelithiasis.~     Patients undergoing laparoscopic cholecystectomy suffer from acute postoperative pain,~     despite a multimodal analgesic regime.~      This is a randomised controlled trial efficay of the Quadratus Lumborum (QL) Block in terms~     of analgesic efficacy in patients who undergo laparoscopic cholecystectomy.~   "
19714|NCT03308942|"~     A phase 2 study to evaluate the efficacy of niraparib alone and in combination with PD-1~     inhibitor in three cohorts: all histologies with high PD-L1 expression (greater than 50%~     TPS), all histologies low PD-L1 expression (1-49% TPS), and squamous cell lung cancer.~     [TPS=Tumor Proportion Score]~   "
19715|NCT03308929|"~     This is a prospective multi-center clinical evaluation following recipients of the G7 Dual~     Mobility hip device. The primary objective is to characterize survivorship of the G7 hip at~     five years post-index procedure. Secondary objectives include documentation of clinical~     outcomes, safety and radiographic data.~   "
19716|NCT03308916|"~     Prospective screening study at Odense University Hospital to assess the effect of transient~     elastography and other serum and imaging markers of liver fibrosis to detect advanced~     fibrosis (Kleiner Fibrosis score F3-F4) in patients at risk of non-alcoholic fatty liver~     disease, alcoholic fatty liver disease, with a control group of participants recruited from~     the general population.~   "
19717|NCT03308903|"~     A common condition associated with ageing is sarcopenia, which is a progressive decrease in~     muscle mass. Sarcopenia is associated with adverse outcomes including increased mortality,~     and places a major burden on healthcare spending, with the annual cost of sarcopenia in the~     United States exceeding that of osteoporosis and hip fracture. In the UK, the prevalence of~     sarcopenia in community-dwelling older people has been estimated at 5% for men and 8% for~     women. Current guidelines for sarcopenia diagnosis require muscle mass to be measured using~     costly devices such as Dual Energy X-ray Absorptiometry (DXA) and Magnetic Resonance Imaging~     (MRI). Previous research has found strong relationships between the sit-to-stand (STS) test~     and both muscle mass and muscle strength. This pilot study aims to examine this relationship~     in community-dwelling older people to develop predictive equations for initial screening of~     sarcopenia.~      Forty subjects will be tested using the diagnostic criteria developed by the European Working~     Group on Sarcopenia in Older People (EWGSOP). Muscle mass will be measured using the DXA and~     diagnostic ultrasound. Muscle strength will be measured using isokinetic dynamometer,~     handgrip dynamometry, and hand-held dynamometry. Functional performance will be measured~     using the Timed-up-and-Go and gait velocity, and the STS. Subjects will perform two variants~     of the STS; the five times STS (5STS), which requires subjects to perform five consecutive~     STS movements as quick as possible, and the 30-second STS (30STS), which requires subjects to~     perform as many STS movements as possible in 30 seconds. All testing will be completed in a~     single session lasting 90 minutes for each subject. Testing will be performed at the~     University of Bedfordshire Polhill Campus. Subject recruitment will be recruited using~     advertisement posters and word of mouth.~   "
19718|NCT03308890|"~     Clinical relapse occurred much earlier and tended to be more severe after cessation of TDF~     than ETV. The follow-up interval and intensity would be different between ETV and TDF after~     discontinuation of therapy. Whether switch therapy from TDF to ETV can modify the pattern of~     relapse is interesting but unclear. Our hypothesis is that entecavir consolidation on~     post-TDF treatment patients reduce and delay the clinical relapse effectively. Hence in this~     proof of concept study we would like to evaluate the effect of 6 months and 12 months of~     entecavir consolidation on post-TDF treatment durability.~   "
19719|NCT03308877|"~     This is a randomized clinical trial to study ways of helping justice-involved people change~     to more healthy behavior.~   "
19720|NCT03308864|"~     The purpose of this study is to compare two talking forms of therapy designed to help reduce~     depressive symptoms in teenagers: Interpersonal Psychotherapy for Adolescents and Treatment~     as Usual.~   "
26903|NCT03214835|"~     The study will take place at Rambam medical center, department of Otolaryngology Head and~     Neck Surgery, for two years. Patients suspected of LPR or laryngeal l tumor and are candidate~     for laryngeal or hypopharyngeal biopsies will be recruited.~   "
19727|NCT03308773|"~     It is well known that the Type 2 diabetes and vascular disease are preceded by over ten years~     by metabolic dysfunction and anatomic changes that can be quantified. In order to develop~     effective preventive strategies and reduce the cost burden to the health care system,~     recognition of the earliest pathophysiology of Type 2 diabetes and vascular disease is~     clinically relevant. The interval retrospective evaluation of data from patient records,~     reflect the effectiveness of the various treatments implemented in clinical practice.~      Prevalence of prediabetes among American adults is estimated to be ~84 million, or one out~     of three Americans. Over a 5-7 year period approximately one third of these prediabetic~     individuals will progress to type 2 diabetes. Prediabetes is a heterogenous group comprised~     of individuals with impaired fasting glucose (IFG), impaired glucose tolerance (IGT), and~     increased A1c (5.7-6.4%). Although different pathophysiologies are present in individuals~     with IFG and IGT, their conversion rate to overt type 2 diabetes mellitus (T2DM) is similar.~      Insulin resistance is a common causal feature of many of the pathophysiologic mechanisms~     linking macrovascular disease and type 2 diabetes. Because hyperglycemia is the major factor~     responsible for the development of microvascular complications, it logically follows that~     prevention of progression of prediabetes to overt diabetes should retard/prevent the~     development of the microvascular complications. From the measurement of plasma glucose,~     insulin, and c-peptide levels during the oral glucose tolerance test, one can derive measures~     of the two core defects responsible for the development of T2DM, i.e. insulin resistance and~     beta cell dysfunction as well as the degree of dysglycemia.~      By combining a standard medical evaluation with the evaluation of cardiovascular biomarkers,~     patients at intermediate risk of vascular disease can be identified. In these patients,~     carotid intima media thickness (IMT) and carotid plaque evaluation is offered to attempt to~     clarify risk.~      The hypothesis of this observational study is that the characterization of the physiology and~     anatomy of patients at risk of developing type 2 diabetes and/or cardiovascular disease can~     stratify risk of developing disease and direct treatment strategies tailored to the~     identified physiologic defect, leading to improvements in the delay or prevention of disease.~   "
19728|NCT03308760|"~     Acute rupture of the Achilles tendon is a very frequent sports injury. Surgical repair is the~     usual treatment in young subjects, and although the optimal technique is still a matter of~     debate, conventional surgery with a direct approach is still the reference technique in young~     sportsmen and women. Studies investigating the evolution of ankle muscle strength following~     surgery for a ruptured Achilles tendon are rare, even though it is a crucial criterion to~     determine the possibility of returning to the sport. This project thus proposes to study, in~     comparison with the healthy ankle:(1) the evolution of muscle strength in the~     flexors/extensors and invertors/evertors of the injured ankle, evaluated using an isokinetic~     dynamometer, and (2) the evolution of stabilometry parameters, at 6 months, then at 12~     months, following surgery for acute unilateral rupture of the Achilles tendon, operated on~     using the conventional technique in young sportsmen and women and in comparison with the~     healthy side.~   "
19729|NCT03308747|"~     The development of a low-grade, chronic, systemic inflammation observed in the elderly~     (inflammaing) has been associated with increased risk for skeletal muscle wasting, strength~     loss and functional impairments. According to studies performed in animals and cell cultures~     increased concentrations of pro-inflammatory cytokines such as IL-6 and TNF-α as well as~     increased levels of hs-CRP lead to elevated protein degradation through proteasome activation~     and reduced muscle protein synthesis (MPS) via downregulation of the Akt-mTOR signaling~     pathway. However, evidence regarding the effects of inflammaging on skeletal muscle mass in~     humans is lacking. Thus, the present study will compare proteasome activation and the protein~     synthetic response in the fasted and postprandial period between older adults with increased~     systemic inflammation and their healthy control counterparts.~   "
19730|NCT03308734|"~     Prostate cancer is the cause of the greatest number of years lived with disability due to~     cancer. Treatment for prostate cancer is associated with significant side effects, such as~     fatigue, loss of muscle mass, strength and reduced quality of life. Cardiovascular disease~     risk is also increased and accounts for the largest cause of mortality in these patients.~      Exercise and physical activity are known to have benefits in patients with prostate cancer~     but time, motivation and enjoyment are often barriers. Reduced Exertion High-Intensity~     Interval Training (REHIT) interventions in the general population achieve similar or greater~     physiological benefits to continuous moderate intensity exercise but for less time~     commitment. Higher intensity training is also perceived as more enjoyable in both healthy~     populations and cancer survivors. REHIT could therefore be a potential solution to these~     barriers.~      The aim of this project is to investigate whether a REHIT intervention results in improved~     cardiorespiratory fitness in patients with prostate cancer. 30 patients will be recruited and~     randomised to a control group or the intervention group. Both groups will undergo~     cardiorespiratory fitness testing pre- and post- the 6 week period of the trial. The~     intervention group will take part in REHIT using maximal oxygen uptake capacity (VO2 MAX)~     measured on a cycle ergometer. The REHIT intervention will be over 6 weeks, involving 3~     sessions per week lasting 10 min and incorporating 2 Wingate sprints of 20 seconds.~     Pre-intervention values for VO2MAX will be compared to post-intervention values to establish~     whether REHIT improves cardiorespiratory function in patients with prostate cancer.~   "
19731|NCT03308721|"~     This study looks at a new study medicine for weight management in people with overweight or~     obesity. The aim of this study is to find out how safe and tolerable the study medicine is.~     The study also looks at how the study medicine behaves in the body and how it is removed from~     the body.~      Participants will either get NNC9204-1177 (the new study medicine) or placebo (a formula that~     looks like the study medicine but does not have active ingredients). Which treatment~     participants get will be decided by chance.~      NNC9204-1177 has not been approved by the United States Food and Drug Administration. Its use~     in this study is experimental. Participants will get 1 or more injections into the skin of~     the stomach area once each week for 12 weeks.~      The study will last for about 5 months. Participants will have 19 clinic visits with the~     study doctor. At certain times during the study, participants will have blood draws and 3~     different kinds of electrocardiograms. Participants will answer mental health questionnaires.~     Women: Women cannot take part if pregnant, breast-feeding or plan to become pregnant during~     the study period.~   "
19732|NCT03308708|"~     Norepinephrine (NE) infusion is used prophylactically to counteract the vasodilator effect of~     spinal anesthesia. prophylactic use of NE infusion is expected to decrease bouts of~     hypotension, vomiting and increase patient satisfaction~   "
19733|NCT03308682|"~     This is an open-label, non-controlled, non-randomized study to investigate the long-lasting~     radiolabeled somatostatin analogue based peptide receptor radionuclide therapy and evaluation~     safety and dosimetry of 177Lu-DOTA-EB-TATE in patients with advanced metastatic~     neuroendocrine tumors. A single dose of 0.50GBq-0.70GBq (13.5-18.9 mCi) of 177Lu-DOTA-EB-TATE~     will be injected intravenously. and monitored at 2, 24, 72,120 and 168 hours post-injection~     with semiquantitative method based on quantitative single-photon emission computed~     tomography/computed tomography (SPECT/CT) performance.~   "
19737|NCT03308630|"~     Psychiatrists have expressed concern at the emergence of education as a serious source of~     stress for school-going children - causing high incidence of deaths by suicide. Many~     adolescents in India are referred to hospital psychiatric units for school-related distress -~     exhibiting symptoms of depression, high anxiety, frequent school refusal, phobia, physical~     complaints, irritability, weeping spells, and decreased interest in school work. Previous~     studies have found significant anxiety, distress, depression, worn outs and severe impact of~     psychological factors on the performances of dental, engineering and medical student. But~     students preparing for competitive exams have not been studied yet.~      Current study reports the scientific evidence of immediate effect of yoga based techniques~     combined with music and Vedic chants on adolescents preparing for competitive exams.~   "
19738|NCT03308617|"~     Peri-implant infections are severe complications after internal fracture fixation surgery.~     Detection of causative agents of orthopedic implant-associated infections (OIAI) is~     demanding. Several authors reported increased identification rates of bacterial prevalence~     using different sonication procedures compared to standard tissue cultures samples,~     especially for low grade infections.~      On the author hand, contamination of implants without clinical signs of infection is reported~     in up to 30% during implant removals after uneventful fracture healing. The raised general~     questions are: 1.) Is a positive microbiological finding the result of contamination during~     the index surgery or during implant removal? 2.) Does contaminated implants without clinical~     or serological signs of infection have a pathological value?~   "
19739|NCT03308604|"~     This is a phase 1 clinical trial evaluating the safety, tolerability of escalating doses of~     AGuIX-NP in combination with radiation and cisplatin in patients with locally advanced~     cervical cancer. Dose escalation will be conducted using the modified toxicity probability~     interval (mTPI) method.~      Three dose levels of intravenous AGuIX nanoparticles will be explored: 20mg/kg (level -1), 30~     mg/kg (level 1) and 50 mg/kg (level 2).~   "
19740|NCT03308591|"~     In recent years, the patients with IB2 and IIA2 stage cervical cancer are still treated with~     radiotherapy and chemotherapy based treatment, but the radiotherapy will severely damage the~     function of ovary, cause endocrine dyscrasia and the sexual function of vagina. So we want to~     study whether neoadjuvant chemotherapy without radiotherapy will achieve the same outcome~     compared with traditional therapy including radiotherapy. So we randomly divide IB2 and IIA2~     stage cervical cancer patients into two groups. The neoadjuvant chemotherapy group will~     receive two courses of chemotherapy basically composed of platinum, and then undergo surgery,~     after that, doctors will add more courses of chemotherapy according to the situations of the~     patients, including whether the patients have the adverse prognostic factors. The control~     group will undergo surgery directly, and then receive chemotherapy and radiotherapy at the~     same time. Then we will compare the outcomes of these two groups, and analyze the therapeutic~     effect, the impact on survival rate and the effect on improving the living quality of patient~     from two groups. All the outcomes will be fed back to clinical doctors and instruct them to~     choose better treatment for patients.~   "
19741|NCT03308578|"~     This study is aimed at examining the alterations in adipose tissue in obstructive sleep apnea~     (OSA) patients in response to treatment with atorvastatin in continuation with standard~     treatment with continuous positive airway pressure (CPAP).~   "
19742|NCT03308565|"~     The purpose of this study is to determine if mesenchymal stem cells (MSC) derived from the~     fat tissue can be safely administered into the cerebrospinal fluid (CSF) of patients with~     spinal cord injury. Adipose-derived mesenchymal stem cells (AD-MSCs) have been used in~     previous research studies at the Mayo Clinic. All subjects enrolled in this study will~     receive AD-MSC treatment, which is still experimental and is not approved by the U.S. Food~     and Drug Administration (FDA) for large scale use. However, the FDA has allowed the use of~     this agent in this research study.~   "
19743|NCT03308552|"~     This phase III trial is designed to explore a higher radiation dose by using IMRT~     simultaneous integrated boost technique with or without concurrent chemotherapy for~     esophageal carcinoma with limited lymph node metastasis.~   "
19744|NCT03308539|"~     is to test the hypotheses that epicardial adipose tissue can be a marker of severity of~     coronary artery disease in myocardial infarction patients~   "
19745|NCT03308526|"~     Prevailing microorganisms causing neonatal sepsis in neonatal intensive care unit of Assiut~     University children Hospital Methods prospective study conducted in the neonatal intensive~     care unit in Assiut university children hospital.~   "
19746|NCT03308513|"~     It is predicted that the number of Pediatric Chronic Critical Illness increases similar to~     adult all over the world. The prevalence of Pediatric Chronic Critical Illness in Turkey is~     unknown. The investigators aimed to evaluate the etiology, comorbid conditions, demographic~     data, prevalence, mortality and costs of these patient in intensive care units in Turkey. In~     this multi-centered study, The investigators will retrospectively review the last 3 year of~     patients receiving treatment at the Intensive Care Unit.~   "
19747|NCT03308500|"~     This study will assess the effectiveness of a high-intensity intermittent games intervention~     (HIIG) on cardiorespiratory fitness and corporal composition. Fifty-four children, aged 9-12~     years, will be randomised into an HIIG or moderate-intensity games (MIG) group. Before and~     after the intervention, participants complete cardiorespiratory fitness and corporal~     composition test. The hypothesis states that there is an improvement in the cardiorespiratory~     fitness and in the body composition implementing high-intensity intermittent games.~   "
19748|NCT03308487|"~     Groups (group 1 receives 1000 IU vitamin D and group 2 receives 2000 IU vitamin D) through a~     random allocation. It is necessary to mention that all cases in each group could be able to~     receive the current supplementation during pregnancy (Folic acid, iron and multivitamin and~     calcium). This study aimed to evaluate the efficacy of two doses of vitamin D supplementation~     (1000 and 2000 IU/d) during pregnancy on maternal and newborn vitamin D status and metabolic~     profile including lipid profile (serum concentration of total cholesterol (TC), low-density~     lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C),~     triglyceride(TG)), glucose homeostasis (fasting glucose, insulin, insulin resistance~     (HOMA-IR)) and inflammatory and oxidative stress (OS) markers and pregnancy outcomes~     including gestational diabetes, preeclampsia, preterm delivery, abortion, cesarian section,~     and also anthropometric data and apgar score of infants compared with placebo.~   "
19750|NCT03308461|"~     Difficult defecation is a common symptom involving with patients'life quality. The stool~     pattern of these patients might be related to the contribution of gut microbiota. This pilot~     study proposed hypothesis that stool pattern could be used as a simple index to screen the~     potential candidates of fecal microbiota transplantation in patients with difficult~     defecation.~   "
19751|NCT03308448|"~     After introducing intravenous erythropoietin (EPO) as an option for treatment of patients~     with indirect traumatic optic neuropathy in 2011 and publishing non inferiority trial in~     Oct.2017), TONTT2 is aiming to find out the best dose and timing of EPO administration in~     this group of patients.~   "
19752|NCT03308435|"~     Aortic valve stenosis (AS) shows high and increasing prevalence in Western civilizations and~     leads to high morbidity and mortality. 15 years ago Alain Cribier performed the first~     catheter-based transfemoral aortic valve replacement at the University of Rouon. This~     historical step initiated a dramatic shift in the treatment of AS with more than 50% of~     patients being treated interventionally instead of the surgical approach, today.~      Comorbidities are major determinants of cardiovascular events and clinical outcome in aortic~     valve stenosis but little is known about psychiatric comorbidities or frailty in these~     patients. Data from our group suggest an inflammatory trigger for depression and potentially~     other psychiatric diseases and aortic valve stenosis as well as aortic valve replacement are~     associated with considerable changes in the inflammatory state of the patients. However, no~     study has prospectively examined the interaction of these inflammatory markers and mood~     disorders, yet. In addition, frailty is a key aspect of many of TAVR patients clinically,~     however, scientifically there is only emerging data with half of all PubMed-indexed~     publications being less than 18 months old and clinical use of various scores still under~     discussion.~      The  Effect of interventional aortic valve replacement on emotional status, quality of life,~     frailty and inflammation-study is designed to fill these gaps in evidence. It will be a~     prospective epidemiological cohort study to recruit 102 patients with symptomatic severe~     aortic valve stenosis within 18 months. All of these patients will undergo standardized~     cardiologic, psychiatric and frailty assessment as well as a sophisticated laboratory~     analysis focussing on the inflammatory state. The study aims to integrate these~     interdisciplinary findings to optimize patient treatment.~   "
19753|NCT03308422|"~     The main objective of this study was to evaluate the distribution of parental representations~     concerning the use of screens by preschool children, expressed in qualitative surveys:~     perceptions of screens as a source of learning, a source of appeasement, a source of~     behavioral difficulties and a source of reduction in the social interactions of young~     children.~      The hypothesis of this study was the representations expressed in the qualitative studies~     were the reflection of the opinion of a majority of parents of young children.~   "
19754|NCT03308409|"~     The patients with primary erectile dysfunction (IIEF-EF <26 points), will be randomly~     assigned to three shockwave treatment protocols: Protocol 1 six sessions, one per week;~     Protocol 2, six initial sessions, one per week, followed by monthly maintenance sessions~     (every 4 weeks) for five months; Protocol 3, six monthly sessions. The EHS and IIEF-EF scores~     will be compared as well as the possible adverse events from the therapy upon beginning and~     completing the treatment and at the 3-month and 6-month follow-ups. Self-esteem and quality~     of life will also be evaluated using the SEAR scale.~   "
19755|NCT03308396|"~     This is a single arm, multi-centre (via Big Ten Cancer Research Consortium) phase Ib/II study~     of patients treated with durvalumab 1500 mg IV q 4 weeks in combination with guadecitabine at~     the recommended phase 2 dose subcutaneously for 5 consecutive days. Eligible patients will~     have metastatic RCC with a clear cell component, ECOG performance status of 0-1, have~     received 0-1 prior therapy but no prior anti-PD-1/PD-L1/CTLA4 (Cohort 1, 36 subjects). Study~     treatment could potentially continue for up to 13 cycles (52 weeks).~   "
19756|NCT03308383|"~     Echocardiography forms one of the most used modality in the evaluation of cardiac anatomy and~     functions in both patients with cardiac symptoms and in healthy individuals for occupational~     and research purpose. The interpretation of any medical investigation including~     echocardiographic report is based on its comparison with the normal range for that parameter,~     which is known to vary depending on the age, sex, body surface area (BSA), ethnicity and~     race. Since most of the medical/surgical treatment decisions are made based on the~     echocardiographic reports, the interpretation of results should be accurate. Even though~     there are many studies defining reference ranges of echocardiographic parameters, most of~     them were based on studies conducted in Western and European population, who shows~     considerable difference in their anthropometric measurements from the Indian population.~     Hence for the accurate diagnosis of any cardiac abnormalities, the reference values should~     have been derived from studies conducted in population of that particular race and ethnicity~     who are free of risk factors for the cardiac disease. Hence the investigator planned to~     conduct a study to determine the normal Echocardiographic parameters and compare it with the~     reference range of established by American society of echocardiography (ASE).~   "
19757|NCT03308370|"~     Melasma is a common acquired disorder characterized by symmetric, hyperpigmented patches with~     an irregular outline, occurring most commonly on the face. The therapy for melasma has always~     been challenging and discouraging. Platelet rich plasma has been used over the last several~     years as an effective treatment in various surgical and medical ﬁelds. In recent years,~     Platelet rich plasma has also started to be used in the field of cosmetology. This study is~     designed to evaluate the therapeutic effect of platelet rich plasma in melasma.~   "
19767|NCT03308240|"~     This study will assess the efficacy of magic therapy services in relieving pediatric patient~     anxiety and parent anxiety in an inpatient setting. It will also measure family satisfaction~     with child life services during the hospital visit and health professional opinions regarding~     such a therapy in an inpatient setting. The primary evaluation method will be through~     surveys. No prior investigations have studied using magic therapy as a primary tool to~     improve the psychological well-being of pediatric patients over the span of an inpatient~     hospitalization. Study and improvement of magic therapy services provides an evidence-based~     approach to improve pediatric patient psychological well-being, assist physicians in~     obtaining pediatric patient cooperation with procedures, and improving the hospitalization~     experience for the family of hospitalized pediatric patients.~   "
19758|NCT03308357|"~     The measurement of serum concentrations of infliximab (IFX)has now become a routine part of~     optimal use of that drug. Trough values are used in two situations: (a) reactively where~     there is loss of response to infliximab - therapeutic concentrations are indicate likely~     non-response to the drug, whereas low levels are associated with the chance of regaining~     response by increasing dosage; or (b) proactively, where dose optimisation in the maintenance~     phase is performed to ensure ongoing efficacy and/or cost-effective use (where high levels~     lead to reduction in dosage without loss of efficacy).~      With the introduction of biosimilar infliximab into clinical practice, it is important to~     demonstrate that the biosimilar behaves similarly in the assay used as does originator~     infliximab to which the assays were developed. While unlikely to be different due to~     identical protein core, such confirmation is needed before such assays can be used in~     clinical practice with confidence.~      AIMS~        1. To compare the concentrations of biosimilar IFX (MSD-IFX) with that of originator IFX~          (orig-IFX) when added to serum form healthy subjects and those with IBD when measured by~          commonly-used commercial assays.~        2. To compare the effect of freeze-thawing and storage at 4 oC on concentrations of~          MSD-IFX.~   "
19759|NCT03308344|"~     This project aims to contextualize delivery of mindfulness and compassion training for~     military spouses and evaluate its effectiveness on measures of executive functions and~     psychological well-being.~   "
19760|NCT03308331|"~     People living with HIV-1 have high rates of cigarette smoking, which may be related to~     nicotinic interaction with HIV-1 infection and brain function levels. The proposed project~     aims to understand these pathways using translational brain imaging and HIV-1 reactivation~     studies. The study proposes a targeted nicotine-brain investigation of the nicotinic effects~     in HIV-1 infection from cellular to brain circuitry levels.~   "
19761|NCT03308318|"~     It has been widely accepted that a split of the deep temporal fascia occurs approximately 2~     to 3 cm above the zygomatic arch, named the superficial and deep layers. The deep layer of~     the deep temporal fascia lies between superficial temporal fat pad and the temporal muscle.~     However, during the investigators' previous surgeries, the investigators did not find the~     deep layer of the deep temporal fascia between superficial temporal fat pad and the temporal~     muscle. This study was conducted to clarify the presence or absence of the deep layer of the~     deep temporal fascia. And the investigators' clinical study has confirmed the absence of the~     deep layer of the deep temporal fascia between superficial temporal fat pad and the temporal~     muscle.~   "
19762|NCT03308305|"~     Rationale: 30-70% of comatose patients admitted to the intensive care unit (ICU) after~     cardiac arrest never regain consciousness as a result of post anoxic encephalopathy (PAE).~     Early identification of patients without potential for recovery of brain functioning may~     prevent inappropriate continuation of medical treatment and improve communication between~     doctors and patients. However, current diagnostic and prognostic measures can identify only~     20-50% of the patients with irreversible brain damage, precluding cerebral recovery and~     awakening. Also, the pathophysiology of brain damage is largely unclear. New magnetic~     resonance imaging (MRI) sequences hold potential to substantially improve outcome prediction.~      Objectives: 1. To estimate the additional value of early MRI monitoring for the prediction of~     neurological outcome of comatose patients after cardiac arrest. 2. To gain insight in the~     pathophysiology of PAE by associating MRI findings with histopathological studies of brain~     tissue obtained from non-survivors.~      Study design: prospective cohort study.~      Study population: 100 subsequent comatose patients after cardiac arrest, admitted to the ICU.~      Intervention: In addition to standard treatments, patients will undergo MRI of the brain at~     day 3, 7, and three months after cardiac arrest. A subgroup of patients will be scanned~     within 24 hours after cardiac arrest, to assess feasibility and to gain more insight in the~     evolution of brain damage in PAE. Survivors will be followed for one year. Outcome~     measurements will focus on disabilities, quality of life, and depression. MRI measures will~     be related to outcome.~      Main study parameters/endpoints: The primary outcome measure is neurological outcome, defined~     as the score on the Cerebral Performance Category (CPC) at six months, dichotomized as good~     (CPC 1-2 = no or moderate neurological disability) or poor (CPC 3-5 = severe disability,~     coma, or death). Secondary outcome measures include cognitive functioning, depression, and~     quality of life at one year, as well as histopathological damage of brain tissue of~     non-survivors.~   "
19763|NCT03308292|"~     Physical inactivity and low adherence to the Mediterranean diet cause alterations in body~     composition, which increases the risk factors for cardiovascular and metabolic diseases. In~     addition, exercise in different surfaces or water could affect the bone density specially in~     women. Objective: The purpose of the study was to analyze the effect of a short-term aerobic~     exercise program in different surfaces on the body composition and bone density of women~     within at work, and to evaluate the quality of the Mediterranean diet and distribution of~     macronutrients in the studied population. Material & Methods: Randomized controlled trial. 63~     women from a randomized work environment (IG, n=34) and a control group (CG, n=29)~     participated in a short-term aerobic exercise programmed (12 weeks), for body composition and~     bone density Dual-energy X-ray absorptiometry (DXA) was used and to evaluate diet, the~     Mediterranean Diet Quality Questionnaire (KIDMED) and the Food Frequency Questionnaire for~     macronutrient distribution were used.~   "
19764|NCT03308279|"~     The main aim of this study was to correlate anthropometric measures of the forearm in healthy~     subjects with the ultrasound pronator teres depth to determine the needle length in order to~     avoid injury of the median nerve during pronator teres dry needle approach. A cross-sectional~     study, was carried out in order to perform a predictive model for the median nerve depth into~     the pronator teres muscle using a decision tree analysis algorithm.~   "
19765|NCT03308266|"~     The aim of this study was to assess the electrical activity of the temporal and masseter~     muscles in cleft lip and palate (CLP) children with pain-related temporomandibular disorders~     (TMD) and in CLP individuals with no TMD by means of surface electromyography (sEMG). Another~     objective was to determine the diagnostic value of electromyography in identifying CLP~     patients with temporomandibular disorders. The sample comprised 87 children with CLP and~     mixed dentition. The children were assessed for the presence of TMD using of the Research~     Diagnostic Criteria for TMD (RDC/TMD) by a single examiner. A DAB-Bluetooth Instrument~     (Zebris Medical GmbH, Germany) was used to take electromyographical (EMG) recordings of the~     temporal and masseter muscles both in the mandibular rest position and during maximum~     voluntary contraction (MVC).~   "
19766|NCT03308253|"~     The CDC quotes a rate of wound infection of 2-5% for inpatient surgery. Patients undergoing a~     vascular operation, however, are generally at an increased risk of wound infection with rates~     often close to 5-10%. Groin incisions are an additional risk factor for surgical site~     infections, with rates of wound infection being quoted from 10-15%, and even as high as 30%~     in high risk patients. The use of implantable calcium sulfate beads mixed with antibiotics~     may help to lower the rate of infection in these high risk patients.~   "
19770|NCT03308201|"~     The purposes of this study are to assess the safety, tolerability of combining Hemay022 with~     exemestane in the treatment of ER and HER2-positive metastatic or advanced breast cancer, and~     to establish OTR( Optimal Tolerated Regimen). The secondary purpose of this study is to~     assess the pharmacokinetics and efficacy of combining Hemay022 with exemestane.~      The study will be conducted in two parts. Part one, trial will be conducted in 15-24 subjects~     to determine safety and tolerability of combining Hemay022 with exemestane in patients with~     HER2-positive advanced breast cancer. Part two, approximately 24 additional subjects with ER~     and HER2-positive advanced breast cancer, are included to better define the tolerability and~     preliminary efficacy of Hemay022.~   "
19771|NCT03308188|"~     This is a 10-month internet-based randomized controlled trial to evaluate whether an online~     chronic pain management program (E-Health) can assist with reduced opioid reliance in~     chronic pain patients. About half of the eligible participants will receive access to the~     E-Health program in addition to their standard chronic pain treatment; the other half will~     just continue receiving their standard chronic pain treatment.~   "
19772|NCT03308175|"~     This study will be conducted to see if unlocking mandible from deep bite in growing females~     by flat fixed anterior bite plane will change mandibular position in skeletal mandibular~     deficiency and if there is a difference in the change of mandibular position if we assisted~     the mandible by holding it in a more forward position by modified inclined fixed anterior~     bite plane .These results will be compared to normal mandibular growth from previous records~     of a matched control group in the discussion afterthat.~   "
19773|NCT03308162|"~     This study is testing the acceptability and feasibility of an active, experiential group~     therapy for health behavior change within a medical setting.~   "
19774|NCT03308149|"~     Fifty MRI scans of patients with chronic lumbar back pain were graded radiologically using a~     wide range of classification and measurement systems. The reported effect of facet joint~     injections at the site was recorded and a comparative analysis performed.~   "
19775|NCT03308136|"~     Lumbar Transforaminal Epidural Injection is helpful for the treatment of lumbosacral~     radicular pain. But needle handling during the procedure may cause pain and discomfort to the~     patient. At the local skin anesthesia step, local anesthetics injection to the muscle layer~     along the needle pathway as well as the subcutaneous layer may reduce the procedural pain. In~     addition, it can reduce the injection site pain that may occur after the procedure.~   "
19776|NCT03308123|"~     This qualitative study is part of the 5-year long (2013-18) PERFECTED (Peri-operative~     Enhanced Recovery hip-fracture Care of paTiEnts with Dementia) National Institute for Health~     Research (NIHR) funded research programme. PERFECTED's overall aim is to develop and pilot an~     evidence-based intervention to improve the hospital care of patients living with dementia who~     have fractured their hip. The findings from this particular study will support PERFECTED's~     other activities by exploring stakeholder (lay and professional) views of the hospital care~     experiences of hip-fracture patients who are experiencing memory difficulties. Best practices~     and priorities, including attention to cost-consequences will be explored.~      Semi-structured interviews will be conducted with 15-30 hip-fracture patients with mild~     memory difficulties recently discharged from acute hospitals in Norwich, Nottingham and~     Bradford. Equal attention will be given to those patients discharged directly home and those~     discharged to community hospitals for further rehabilitation. Interviews will be conducted~     with 15-30 recognised carers of hip-fracture patients with moderate/severe memory~     difficulties who have recently been discharged from acute hospitals in the same three~     regions. Semi-structured interviews will also be carried out with a nominated dementia lead~     in each region. Finally, in each region, small focus groups, face-to-face or telephone~     interviews will be conducted, with clinical staff of various grades and professions, hospital~     managers and with NHS commissioners. This study will enable a range of topics and~     perspectives to be explored and potential components for PERFECTED's intervention to be~     identified.~      As part of PERFECTED's on-going commitment to Public Patient Involvement (PPI), lay~     researchers will be trained to assist in interviewing recognised carers of hip-fracture~     patients with moderate/severe memory difficulties. Interviews and focus groups will be~     recorded, transcribed and analysed thematically. Resulting data will address the pre-defined~     aims of the current study and feed into findings reported across the whole of Work Package 1~     of PERFECTED.~   "
19777|NCT03308110|"~     Bioavailability and food effect of 2 formulations of PF-06650833 in healthy volunteers.~   "
19778|NCT03308097|"~     This study will develop and test an interactive mobile messaging intervention to improve~     engagement in care related to Pre-exposure Prophylaxis (PrEP) and decrease HIV risk behaviors~     for Black men who have sex with men living in the Southern U.S. The mobile messaging~     intervention will include interactive text messaging and free, publicly available links to~     websites and YouTube videos. During the intervention participants will gain information about~     their health, improve motivation for engagement in PrEP related care, and build skills for~     healthy behaviors. Participants will also receive intervention materials to help decrease~     frequent barriers to care. If the intervention is found to be effective, it can be tested in~     a larger study and then disseminated.~   "
19779|NCT03308084|"~     The purpose of this study is to determine if the frequency and duration of postoperative pain~     are improved in participants receiving a local steroid injection (methylprednisolone) plus a~     systemic (intravenous (IV, by vein)) steroid (dexamethasone) when compared to those receiving~     a systemic (IV) steroid (dexamethasone) alone. Both of these steroid injections are already~     currently used at Rush and are considered standard of practice. It is well established that~     steroids have an anti-inflammatory (decreased swelling) effect on the soft tissue and it is~     routinely used in many types of surgery, but it is not known whether two steroids are better~     than one. The medications provided in this study are approved by the Food and Drug~     Administration (FDA).~   "
19780|NCT03308071|"~     The purpose of the study is to determine if teaching self-hypnosis techniques to patients~     prior to knee replacement surgery will decrease their pain medication requirements, pain~     medication side-effects, length of stay in the hospital, readmission rates, pain, anxiety,~     physical function, satisfaction scores, and cost of admission.~   "
19791|NCT03307928|"~     Elderly have a high prevalence to systemic arterial hypertension (SAH) and obstructive sleep~     apnea (OSA). Both comorbidities are closely associated and inflict injury cardiorespiratory~     capacity. To assess cardiorespiratory responses to the cardiopulmonary exercise test (CPET)~     among hypertensive elderly with OSA. We enrolled 25 elderly hypertensive in two different~     groups: without OSA (No-OSA: Apnea/Hypopnea Index (AHI) < 5 events/h; n = 15) and with OSA~     (OSA: AHI ≥ 15 events/h; n = 13). All subjects underwent a CPET and polysomnographic~     assessments. After normality and homogeneity evaluations, independent t test and pearson's~     correlation were performed. The significance level was p ≤ 0.05.~   "
19792|NCT03307915|"~     The primary purpose of this study is to assess safety/tolerability of 2 different prime/boost~     regimens containing adenovirus serotype 26 (Ad26).Mos4.HIV, Modified Vaccinia Ankara (MVA)~     -Mosaic or adjuvanted Mosaic and Clade C gp140 in Human immunodeficiency virus type 1~     (HIV-1)-infected participants on suppressive antiretroviral treatment (ART).~   "
19781|NCT03308058|"~     Breastfeeding has many positive and long lasting impacts on the health of infants and~     mothers. The investigators propose to develop a bilingual touch screen computer based~     breastfeeding educational support program to promote breastfeeding among Hispanic rural women~     living in Scottsbluff area of rural Nebraska. An interactive, tailored, touch screen,~     bilingual breastfeeding educational program will be developed to deliver breastfeeding~     education to enhance partial or exclusive breastfeeding. An experimental two-group repeated~     measures design will be utilized. Ninety four prenatal Hispanic rural women aged 15 years and~     above will be enrolled and randomly assigned to either the intervention (computer based~     program, N=47) or attention control (printed educational material, N=47) groups at the~     Regional West Medical Center in Scottsbluff. Information gathered will include~     socio-demographics, familiarity with use of technology and health literacy assessment.~     Process variables measured will include breast-feeding knowledge and breast-feeding~     self-efficacy. Primary and secondary outcomes include breast-feeding duration in binary~     categories (partial or exclusive) and number of sick baby medical visits and months of~     illnesses. All assessments will be done at baseline, days 3 and 7, weeks 2 and 6 and months 3~     and 6 in both the intervention and attention intervention groups. The current proposed study~     may help advance our understanding to use health information technology as a medium to~     disseminate bilingual health education programs in rural settings. This exploratory study~     will lay a foundation for a larger multicenter randomized controlled clinical trial to~     evaluate the impact of computer based educational intervention to promote sustainability of~     breastfeeding among women across diverse settings.~   "
19782|NCT03308045|"~     Primary objective: safety and tolerability~      Secondary objectives: additional indicators of long term safety and indicators of clinical~     activity~      Exploratory objectives: to characterize EYS606 biodistribution, immunogenicity and biomarkers~   "
19783|NCT03308032|"~     The proposed project seeks to develop an online self-directed learning (SDL) intervention~     program that seeks to improve caregiving and self-care skills among ethnic Chinese dementia~     caregivers. The benefits of such a product may include improved psychological health in~     caregivers and a reduction in behavioral disturbances among elderly care recipients with~     dementia.~   "
19784|NCT03308019|"~     This study evaluates the efficacy of scaling and root planing with and without adjunct~     antimicrobial photodynamic therapy (aPDT) in the treatment of chronic periodontitis (CP)~     among cigarette-smokers and never-smokers.~   "
19785|NCT03308006|"~     In 1990, the prevalence of osteoarthritis of the hip or knee was very low 3.5% in Saudi~     Arabia, it increased to 53.3% and 60.9% in male in female patients respectively in 2002. The~     existing management of OA is conservative and pharmacological management aiming to relief~     symptoms of osteoarthritis and improves joint function. Results of a Meta-Analysis showed~     that mesenchymal stem cell is effectiveness and safe to treat knee osteoarthritis. In 1990,~     the prevalence of osteoarthritis of the hip or knee was very low 3.5% in the Kingdom of Saudi~     Arabia and it increased to 53.3% and 60.9% in male in female patients respectively in 2002.~     Results of a Meta-Analysis showed that mesenchymal stem cell is effectiveness and safe to~     treat knee osteoarthritis. This study will be a single center phase II-one arm clinical~     trial. It will be conducted at KF SH&RC-Jeddah. 18 participants will be recruited from~     orthopedic clinics. Participate will be evaluated before inclusion in the study. Participants~     will be exposed to e abdominal liposuction procedure under local anesthesia for stem cells~     harvesting. Stem cells will be separated from fat cells in the adipose tissue then activated~     in Tissue Culture Lab at Research Center- Jeddah. The activated stem cells will be injected~     into the knee joint via 22G spinal needle. The intra-articular stem cells injections will be~     performed under Ultrasound guidance at the theater under spinal anesthesia. Each patient will~     receive 1.0× 108 stem cells in 3 mL of normal saline~   "
19786|NCT03307993|"~     To investigate the brain receptor occupancy of idalopirdine in patients with Alzheimer's~     disease (AD)~   "
19787|NCT03307980|"~     Long-term safety follow-up for subjects with Hemophilia B and previously treated in the~     SPK-9001-101 protocol~   "
19788|NCT03307967|"~     Veterans seeking compensation for musculoskeletal (MSD) conditions often develop chronic pain~     and are at high risk for substance misuse. The Investigators propose to test the~     effectiveness and cost-effectiveness of Screening, Brief Intervention and Referral to~     Treatment for Pain Management (SBIRT-PM), designed to reduce pain and reduce risky substance~     use, in part by helping Veterans get comprehensive pain treatment. The study will involve a~     2-year period to arrange for clinicians at a single site to counsel Veterans throughout New~     England by phone with SBIRT-PM as part of a clinical trial, and a 4-year period to conduct~     the trial and disseminate its findings.~   "
19789|NCT03307954|"~     Spinal cord injury (SCI) leads to rapid and profound bone loss with large decreases in bone~     mineral density (BMD) below the level of the lesion. Decreases in BMD of ~2% per month from~     the lower limbs have been reported and rates of loss are maximal over the first two years. As~     a consequence, there is an increased risk of fragility fractures particularly of the lower~     limbs including an increased risk of hip fracture. Lower limb fragility fractures affect up~     to 35% of patients following SCI. These fractures are associated with considerable morbidity~     and an increase in mortality.~      This single centre UK study will determine if it is feasible to carry out a randomised~     controlled BMD study in the acute SCI patient population. The study will compare the BMD of~     patients who receive Ekso Therapy (powered exoskeleton device) verse patients who receive~     usual physiotherapy alone (control group). It will address patient recruitment rates and~     reasons for withdrawal from the study and highlight any practicality issues with study~     conduct. It will also provide preliminary data on the effects of Ekso Therapy on BMD,~     biochemistry and bone turnover markers.~   "
19790|NCT03307941|"~     ARTemIS-Eso is a phase I-II, three-level, open-label trial with a dose-expansion cohort at~     recommended schedule in both esophageal cancer histological groups (squamous cell carcinoma~     and adenocarcinoma) of RCT and ImT administered prior to surgery.~   "
20087|NCT03304041|"~     The primary aim of our study is to carry out a randomized trial to evaluate the efficacy of~     low-FODMAPs dietary therapy compared to conventional therapy for IBS patients recruited from~     tertiary hospitals in China. Secondary aims of this research include an analysis of clinical,~     physiological and microbiological factors that may predict IBS patient response to this~     dietary intervention.~   "
19793|NCT03307902|"~     During the course of chronic hepatitis B infection, patients may undergo hepatitis B surface~     antigen (HBsAg) seroclearance, resulting in undetectable circulating HBsAg. With the advance~     of sensitive nucleic acid detection techniques, HBsAg-negative subjects with detectable HBV~     DNA in sera or liver tissues can be identified. Patients who have undetectable HBsAg and yet~     detectable HBV DNA in sera or liver tissues are defined as having occult HBV infection (OBI).~     OBI as a cause of liver disease in HBsAg-negative patients remains clinically important~     [1,2]. Studies conducted by our research group had demonstrated that patients with HBsAg~     seroclearance could still develop flare of hepatitis B, advanced liver diseases and HCC~     [3-6]. Prevention of these complications in OBI patients by conventional intramuscular~     hepatitis B vaccination (HBVv) remains elusive with poor amnestic anti-HBs response [7].~      The objective of this prospective double-blind randomized controlled trial is to evaluate the~     effect and safety of topical treatment with imiquimod immediately before intradermal~     vaccination with Sci-B-Vac™ in patients with OBI. Our a priori hypothesis is that imiquimod~     pretreatment would improve immune responses to Sci-B-Vac™ further in OBI patients, resulting~     in HBsAb conversion. Thereby preventing subsequent complications including flare of~     hepatitis, cirrhosis and HCC in these patients.~   "
19794|NCT03307889|"~     Observational study in which pulse transit time (PTT) as a method and the device to register~     this data is compared with arterial blood pressure.~      The population is composed of pediatric and adult patients in anesthesia or intensive care in~     need of arterial blood pressure monitoring.~   "
19795|NCT03307876|"~     A cartilage degradation product, the Fibronectin-Aggrecan complex (FAC), has been identified~     in patients with degenerative disc disease (DDD). Alpha-2-macroglobulin (A2M) can prevent the~     formation of the G3 domain of aggrecan, reducing the fibronectin-aggrecan G3 complex and~     therefore may be an efficacious treatment. The present study was designed to determine 1) the~     ability of autologous concentrated A2M to relieve back pain in patients with LBP from DDD and~     2) the ability of FAC to predict the response to this biologic therapy.~      24 patients with low back pain and MRI-concordant DDD had prospective evaluation. Oswestry~     disability index (ODI) and visual analog scores (VAS) were noted at baseline and at 3- and~     6-month follow-up. Primary outcome of clinical improvement was defined as patients with both~     a decrease in VAS of at least 3 points and ODI >20 points. Molecular discography and delayed~     FAC analysis and injection of platelet poor plasma at the time of the procedure. Patients~     with FACT-positive assays were significantly more likely to show improvement in their VAS and~     ODI at follow-up.~   "
19796|NCT03307863|"~     Data on the interaction between the etonogestrel (ENG) implant and antiepileptic drug (AED)~     regimen are scarce. We will evaluated the effect of 2 AED regimens (1 including carbamazepine~     and the other topiramate) on the pharmacokinetic (PK) parameters of an ENG-releasing implant~     in women with epilepsy.~   "
19797|NCT03307850|"~     This clinical trial will identify exercise-related and emotional stress related effects on~     glycemic control in patients with type 1 diabetes using sensor-augmented pump (SAP) therapy.~   "
19798|NCT03307837|"~     This is a single-center, randomized, double-blind, placebo-controlled, single ascending dose,~     sequential-group Phase 1 study. The study will be conducted utilizing a cohort design, with~     sequential groups of 8 subjects. Within each dose cohort, 6 subjects will be randomized to~     active, and 2 will be randomized to placebo.~   "
19799|NCT03307824|"~     Laparoscopic sacrocolpopexy has now become the gold standard technique for correction of~     anterior and apical prolapse. In order to provide an alternative to stapling system and~     sutures involving vaginal erosion and shrinkage phenomena, there is a technique to fix~     material meshes by the use of a liquid, tissue, synthetic adhesive and sterile. The~     investigator hypothesizes that the use of IFABOND ™ adhesive in laparoscopic sacrocolpopexy~     significantly reduces the time of surgery compared to the classic suture technique. The~     prospective, randomized, multicenter study therefore aims to compare the time of surgery when~     using the IFABOND™ synthetic adhesive and the technique by sutures to fix material meshes in~     laparoscopic sacrocolpopexy.~   "
19800|NCT03307811|"~     This is a prospective study to determine the optimal technique for obtaining liver tissue~     with a smaller caliber (22 gauge) needle and whether a good core biopsy can be obtained~     without the use of suction and secondly to determine the diagnostic yield and safety of 22 g~     Fine Needle Biopsy needle for liver biopsy.~   "
19801|NCT03307798|"~     Bone quality is one of the major factors influencing the dental implant survival rate. Bone~     quality is believed to have effects on initial implant stability and success of~     osseointegration. Different implant designs and surgical protocols were developed for~     improving the survival rate in different bone quality. Although bone quality can be partly~     diagnosed by radiographic images, lots of experienced surgeons also evaluate bone quality~     with tactile sensation when they drill the bone. However, variations in evaluation of bone~     density maybe exist among different surgeons. For less experienced dentists, it is difficult~     to diagnose bone quality with tactile sensation in the beginning. This purpose of this study~     is to evaluate a training protocol in using tactile sensation to classify bone quality during~     implant surgery. Saw bones of variant densities are used as training materials. The outcomes~     before and after training will be compared. The effect of training frequency before surgery~     will also be evaluated.~   "
19802|NCT03307785|"~     Part A: To test the safety and tolerability of combination therapy with Niraparib and TSR-042~     and to establish a safe dose that will be used in a Phase 2 study.~      Part B: To test the safety and tolerability of combination therapy with~     Carboplatin-Paclitaxel and TSR-042 and to establish a safe dose that will be used in a Phase~     2 study.~      Part C: To test the safety and tolerability of combination therapy with Niraparib, TSR-042~     and Bevacizumab and to establish a safe dose that will be used in a Phase 2 study.~      Part D: To test the safety and tolerability of combination therapy with~     Carboplatin-Paclitaxel, TSR-042 and Bevacizumab and to establish a safe dose that will be~     used in a Phase 2 study.~   "
19889|NCT03306628|"~     This is a prospective, randomized pilot study of patients who will undergo either early or~     late incisional laser therapy after breast reduction surgery to alleviate scar burden at NYU~     Langone Medical Center. The purpose of this study is to see how well carbon dioxide (CO2)~     laser therapy works at preventing scar formation after surgery.CO2 laser therapy is currently~     being used by dermatologists and plastic surgeons to help with scarring after acne and to~     rejuvenate the face; its benefits are now being explored by medical professionals in~     dermatology and cosmetic surgery to prevent scarring after surgery.~   "
19803|NCT03307772|"~     Background: Herpes labialis is the result of the presence of Herplex Simplex Virus -1 (HSV-1)~     and is a common disease in the population. Because of its visibility it has a serious impact~     on social life and the feeling of well-being in people who suffer from this disease. Until~     now there is no effective treatment and no remedy for prevention of the virus outbreak.~      Prebiotics and probiotics have both been shown to have a favorable and supportive effect on~     the immune system in different health conditions such as influenza, atopic dermatitis and~     diarrhea. So far no study has addressed the effect of the consumption of pre- and/or~     probiotics in a population with recurrent herpes labialis.~      Aim of the study: The present study investigated the effect of pre- or probiotics or a~     combination of the two on the recurrence of herpes labialis lesions as well as on the immune~     system in general.~      Design: 78 Patients were eligible to participate in the study and after a run-in period of~     two weeks consuming a placebo minidrink were randomized to one of the four experimental~     groups, these were: placebo minidrink (n=), prebiotic (fructooligosaccharides) minidrink~     (n=), probiotic (Lactobacillus rhamnosus GG or LGG) minidrink (n=) or a minidrink containing~     a combination of a pre- and probiotic. These minidrinks were consumed for another 5 weeks. At~     day 33 of the study the lip most prone to the development of a lesion was stimulated with UVB~     in order to provoke a lesion. During the entire study period subjects were checked for any~     clinical signs of a lesion, completed a self-assessment regarding the lesion and a quality of~     life questionnaire at baseline (day 14) and the end of the study (day 49). In addition, a~     blood sample was collected at baseline and at the end of the study to be analyzed for general~     and HSV-specific antibodies, intracellular cytokine concentrations and parameters of the~     innate immune response such as natural killer cell activity and phagocytosis.~   "
19804|NCT03307759|"~     This investigator driven Phase Ib study will examine the safety, efficacy and biological~     effects of two schedules of pembrolizumab, an antibody targeted against anti-programmed cell~     death 1 (PD-1), which will be given either before or after stereotactic ablative body~     radiotherapy (SABR) for metastatic NSCLC.~   "
19805|NCT03307746|"~     A total of 40 participants will be recruited, with 20 participants in each of the following~     subcategories:~      A) High grade lymphoma (DLBCL, FL grade 3b, transformed FL) (n=20) B) Low grade lymphoma~     (e.g. FL grade 1, 2 or 3a, MZL, MCL) (n=20)~      The main purpose for having two experimental treatment arms is to provide a comparator for~     the translational endpoints, i.e. to assess whether the differences observed are due to the~     addition of varlilumab to rituximab. The only difference between Arm A and Arm B is the delay~     in administration of varlilumab in cycle 1, which is on Day 2 in Arm A and Day 8 in Arm B. As~     the post-treatment tissue collection occurs on Day 7/8, prior to administration of varlilumab~     in Arm B, samples will be obtained from participants that have either been treated with~     rituximab alone, or both rituximab and varlilumab. To minimise any potential risks to the~     patient as a result of a repeat biopsy on Day 7/8, a prerequisite for entry to the trial is~     that the participants must have accessible sites for biopsy. Difference in response rates~     between Arm A and Arm B are not expected.~   "
19806|NCT03307733|"~     A physical activity feasibility randomised control trial for pregnant, obese women.~   "
19807|NCT03307720|"~     Agonist triggering in controlled ovarian stimulation protocols is being used during last~     years (among high responder patients to avoid OHSS).~      Indeed, agonist triggering is more physiologic than HCG triggering. Investigators propose to~     compare the effectiveness of both types of trigger among three different subsets of patients:~        1. Poor responders.~        2. Normo-responders~        3. High responders Comparing both the number and the quality of achieved oocytes.~   "
19808|NCT03307707|"~     the objective of this study is to :~      -Determinate wether the circulating levels of iFGF23 and klotho can be a predictor biomarker~     of HF in patients with CKD-MBD.~   "
19809|NCT03307694|"~     In this study the researchers will scan the thyroid nodules of patients scheduled for~     surgical removal of these nodules. During their preadmission testing, but prior to their~     surgery, the researchers will perform standard ultrasound and shear wave elasticity imaging~     (SWEI) scans of the thyroid nodules in these patients. Both images can be generated by the~     same ultrasound scanner and within the same imaging session without having to switch out any~     equipment. The results of the SWEI scans will be compared to the definitive diagnosis from~     pathology obtained after pathologists have examined the removed nodules post-operatively.~   "
19810|NCT03307681|"~     The purpose of the present study is to explore the influence of cooking methods on~     post-prandial glycaemia and its impact on satiety in children.~   "
19811|NCT03307668|"~     The purpose of this trial is to investigate the safety and effect of CaReS-1S to repair knee~     cartilage defects.~   "
19812|NCT03307655|"~     Several studies indicate that Nitric Oxide (NO) plays an important role in the physiology of~     the reproductive system in mammals. It has been shown that NO affects sperm motility, it~     regulates the tyrosine phosphorylation of different sperm proteins, it enhances the sperm~     binding ability to the zona pellucida and it modulates the acrosome reaction.~      The enzyme responsible for NO synthesis, the Nitric Oxide Synthase (NOS), has also been~     identified in the oocytes, cumulus and corona cells, as well as in the oviduct. For these~     reasons, the NOS presence at the fertilization site could be a key element to determine the~     success of this process. Therefore, carrying out in vitro studies to better understand NO's~     role in the fertilization process, especially in human sperm capacitation, could improve the~     outcome of the Assisted Reproductive Techniques (ARTs) due to an improvement both in the~     diagnosis of infertility and in the prognosis of treatment success.~      This study is carried out in collaboration with the Animal Physiology Department from the~     Veterinary Faculty (University of Murcia, Spain) and it is funded by the European Commission~     under the Horizon 2020 Programme.~   "
19813|NCT03307642|"~     Children whose parents receive text reminders are more likely to be consented to participate~     in the school located influenza vaccination clinic than children whose parents do not receive~     text reminders.~   "
19814|NCT03307629|"~     The study is intended as a Proof of Concept and dose confirmation study. The primary~     objective of this study is to observe safety and tolerability of idronoxil (NOX66) in~     combination with radiotherapy (at palliative doses) in patients with metastatic~     castrate-resistant prostate cancer (CRPC) and to confirm dose in order to progress to Phase~     2/3.~   "
19815|NCT03307616|"~     The goal of this clinical research study is to learn if giving nivolumab alone or in~     combination with ipilimumab before standard-of-care surgery can help to control sarcoma. As~     part of your standard-of-care, you may also receive radiation therapy. The safety of this~     combination will also be studied.~      This is an investigational study. Ipilimumab and nivolumab are FDA approved and commercially~     available to treat melanoma, lung cancer, and renal cell cancer. It is considered~     investigational to use these drugs to treat sarcoma. The study doctor can explain how the~     study drugs are designed to work.~      Up to 40 participants will be enrolled in this study. All will take part at MD Anderson.~   "
19816|NCT03307603|"~     This study has two portions. The main goal of the Phase Ib portion of this research study is~     to see at what time Yttrium-90 (Y-90) radioembolization therapy and nivolumab can safely be~     given to patients without having too many side effects. Other purposes of this research study~     will be to study any tumor responses.~      The Phase II portion of the study will test how many patients show shrinkage in their tumor~     with this combination of medicines and what changes occur inside the cancer cells and blood~     cells after treatment. The study team will pick the part of the study each subject~     participates in.~      Y-90 radioembolization therapy is minimally invasive procedure that combines two types of~     therapy (embolization which blocks certain blood vessels, and radiation therapy, which kills~     cancer cells) to treat cancer tumors in the liver. This works with tiny glass or resin beads~     filled with the radioactive isotope yttrium-90 (Y-90). They are placed inside the blood~     vessels that feed the tumor in the liver. This blocks the supply of blood to the cancer cells~     and delivers a high dose of radiation to the tumor while sparing normal tissue.~      Nivolumab is an FDA approved medicine that is used for the treatment of different types of~     cancers and metastases (second growths from cancer).~   "
19817|NCT03307590|"~     dexmedetomidine is an alpha 2 adrenergic receptor agonist that is given either systemically~     or combined to local anesthetics during regional blocks. Investigators studied the~     combination of dexmedetomedine/bupivacaine versus bupivacaine alone for caudal blockage in~     pediatric patients undergoing supra - umbilical surgeries.~   "
19818|NCT03307577|"~     UHE-101 cream, 1% (UHE-101) is being developed for the topical treatment of acne vulgaris.~     The purpose of this study is to compare the safety and efficacy of twice daily topical~     application of UHE-101 cream for 12 weeks to its vehicle cream in subjects with facial acne~     vulgaris.~   "
19819|NCT03307564|"~     The goal of this pilot imaging study is to evaluate the visibility of marking the interface~     between the pancreas and duodenum with TraceIT Tissue Marker. Patients with a pathologically~     confirmed diagnosis of BR/LAPC (borderline resectable/locally advanced pancreatic cancer)~     pancreatic adenocarcinomas indicated for neo-adjuvant image-guided radiotherapy with SBRT~     (stereotactic body radiation therapy) will be enrolled. This study will thus set the stage~     for further investigations using the TraceIT Tissue Marker to avoid duodenum toxicity with~     imaging localization, enabling further dose intensification with SBRT or IMRT to improve the~     clinical outcomes in BR/LAPC.~   "
19820|NCT03307551|"~     Automated delivery of propofol using computer-controlled closed loop anaesthesia device~     delivers propofol based on patient's frontal cortex electrical activity as determined by~     bi-spectral index (BIS). Evaluation of anaesthesia delivery by these systems has shown that~     they deliver propofol and maintain depth of anaesthesia with far more precision as compared~     to manual administration.~      By automatically controlling anaesthesia depth consistency they provide time to the~     anaesthesiologist to focus on other aspects of patient care such as managing intra-operative~     hemodynamics and ventilation perturbations during major surgeries.~      Closed loop anaesthesia delivery system (CLADS) is an indigenously developed continuous~     automated intravenous infusion system which delivers propofol based on patients EEG profile~     (BIS) feedback. Although a few studies have already evaluated these automated systems in~     patients undergoing thoracic surgery, but suffered from significant limitations (small number~     of patients, not dedicated to thoracic surgery cohort). Currently, there is no data available~     regarding CLADS performance vis a vis adequacy of GA and haemodynamic profile in patients~     undergoing thoracic surgery.~      We contend that propofol as delivered by CLADS will proffer greater consistency to~     anaesthesia depth, intra-operative hemodynamic stability, and rapid recovery upon anaesthesia~     discontinuation than manual means of delivering propofol TIVA. This randomised controlled~     study aims to compare the efficiency of CLADS-driven propofol TIVA versus manually controlled~     propofol TIVA in patients undergoing thoracic surgery.~   "
19821|NCT03307538|"~     Rationale:~      For patients with perihilar cholangiocarcinoma, surgery is the only treatment modality that~     can result in cure. Unfortunately, in the majority of these patients the tumors are found to~     be unresectable at presentation due to local invasive tumor growth or the presence of distal~     metastases. For patients with unresectable cholangiocarcinoma palliative chemotherapy is the~     standard treatment yielding an estimated median overall survival of 12-15.2 months. There is~     no evidence from randomized trials that support the routine use of stereotactic body~     radiation therapy (SBRT) for cholangiocarcinoma. However, small and most often retrospective~     studies combining chemotherapy with SBRT showed promising results with overall survival~     reaching up to 33-35 months.~      Based upon these observations, the investigators designed a local feasibility trial with SBRT~     after chemotherapy in patients with unresectable perihilar cholangiocarcinoma in order to try~     to confirm the observed tolerability of adding SBRT to standard chemotherapy. The expected~     time to include the required patients for this pilot study will be one year.~      Objective:~      To assess feasibility of SBRT as add on treatment after standard chemotherapy.~      Study design:~      Local feasibility trial.~      Study population:~      Patients diagnosed with perihilar cholangiocarcinoma, 18 years of age or older, T1-4 N0-1 M0~     (AJCC 7th Edition), after completion of standard chemotherapy. Exclusion criteria are local~     tumor growth into either stomach, colon, duodenum, pancreas or abdominal wall. Sample size~     will be 6 patients.~      Intervention:~      SBRT will be delivered in 15 fractions of 3 to 4.5Gy after 8 cycles of chemotherapy. In case~     of toxicity causing premature termination of systemic treatment, the patient can still~     proceed to SBRT.~      Main study parameters/endpoints:~      The primary endpoint of this study is feasibility measured by radiotherapy induced toxicity~     according to CTC v4.0.3.~      Secondary endpoints will be:~        -  Quality of life~        -  Local progression~        -  Progression free survival~        -  Overall survival~        -  Cellular radiosensitivity.~   "
19822|NCT03307525|"~     This is a pilot observational study assessing various predictors for acute pain and~     persistent pain following breast surgery for cancer.~   "
19823|NCT03307512|"~     This will be a randomized, open-label, active-controlled, single dose crossover study with~     either three or four treatment periods. Investigational treatment is with Dance 501 Human~     Insulin Inhalation Solution (Dance 501) and the comparator is Insulin Lispro (Humalog®).~      Target population will be Non-Diabetic individuals with mild to moderate asthma or chronic~     obstructive pulmonary disease (COPD) and non-diabetic individuals without underlying lung~     disease (healthy subjects).~   "
19824|NCT03307499|"~     This study is a prospective, single center, postmarket study to evaluate the safety and~     effectiveness of NeoPatch used as a tissue cover in foot and ankle tendon revision and repair~     surgery.~   "
19870|NCT03306888|"~     This study will evaluate the feasibility and acceptability of a clinic-based physical~     activity coaching intervention in people with pre-manifest and early stage Huntington's~     Disease (HD). Fourteen individuals with premanifest and early stage HD will be recruited to~     participate in a 4 month coaching intervention. Feasibility will be assessed by recruitment~     and retention rates, and acceptability will be assessed by participant interviews.~     Participants will also be evaluate at baseline and following the coaching intervention to~     explore preliminary efficacy in terms of physical activity, self efficacy, disease-specific~     motor and cognitive function, walking endurance and strength.~   "
19825|NCT03307486|"~     Gestational diabetes (GDM) is the most common hormonal complication during pregnancy. Its~     occurrence implies an increased risk of maternal and fetal complications and, therefore, its~     diagnosis and treatment are extremely important. Since the adoption of the new diagnostic~     criteria proposed by the International Association of Diabetes and Pregnancy Study Groups~     (IADPSG) in 2010, an increasing number of cases of mild hyperglycemia have demanded follow-up~     and treatment. The need and benefit of treatment in these cases of mild hyperglycemia has~     been discussed worldwide. Women who have been diagnosed with GDM are at increased risk for~     type 2 DM in the years following gestation. Other factors (such as lipid profile, obesity,~     adipokine dosage) may also be related to the repercussions of GDM on the maternal-fetal~     binomial, since gestations with satisfactory glycemic control can also present complications~     related to the disease and increased risk of type 2 DM in the long term. The present study~     aims to investigate factors associated with the need for insulin use, the occurrence of~     perinatal complications, nutritional status, physical activity and weight retention one year~     after delivery and the postpartum diagnosis of type 2 DM 10 years after delivery in women~     diagnosed with GDM according to the current criteria suggested by the IADPSG.~   "
19826|NCT03307473|"~     Physical inactivity and sedentary are recognized as important risks factors for several~     diseases and total mortality. One of the main perceived barriers to physical activity is the~     lack of time and motivation. Active commuting during daily routine could overcome these~     barriers and e-bikes appears to be a promising and practical tool to meet physical activity~     guidelines.~      E-bikes are a physically active transportation mode, with a riding intensity contributing to~     activities in the moderate-intensity range (3-6 METs) for any of the assistance mode.~     Electric assistance is provided only when a rider is pedaling. The study VELONAPS mainly aims~     at investigating if real-life usage of utilitarian e-bike is associated with significant~     changes on total physical activity and sedentary patterns. During up to 4 months of free use~     of an e-bike, our purpose is to quantify its usage along with total physical activity and~     sedentary levels. We hypothesize that using an e-bike for commuting increase the total~     physical activity of at least 7.5 MET-h/week, increasing as well adherence to physical~     activity guidelines.~   "
19827|NCT03307460|"~     Prospective study to evaluate the value of uPAR-targeted PET/MR scan using the tracer~     68Ga-NOTA-AE105 in patients with newly diagnosed prostate cancer~   "
19828|NCT03307447|"~     This is a phase IV, single-center, open label, single arm study in which a group of 30~     subjects with moderate to severe plaque psoriasis will receive secukinumab therapy.~     Non-invasive imaging with optical coherence tomography (OCT) will be used to monitor the~     resolution of psoriatic plaques with treatment in comparison to observed clinical~     improvements. Early subclinical finding will be used to elucidate drug mechanism of action.~     Assessment will be based on intrasubject comparisons, and all findings will be compared to~     patients baseline imaging.~   "
19829|NCT03307434|"~     The practice of Athletics leads to risk of injuries: about 61 to 76% athletes will occurred~     at least one injury during a season. The prevention of Athletics injuries thus represents a~     major challenge for all stakeholders around athletes. In team sports, injury prevention~     programs have been implemented and scientifically validated. However, no injury prevention~     programs have been implemented and scientifically validated for Athletics. In this context, a~     primary objective will be to analyze the effectiveness of an Athletics Injury Prevention~     Program (AIPP) to reduce the frequency (percentage) of athletes presenting at least one~     injury complaint related to athletic practice at long term (40 weeks). A statistician will~     carry out a randomized control trial in cluster (clubs with AIPP and clubs without AIPP),~     multicenter, including athletes between 15 and 40 years old and licensed in athletic clubs~     and followed during an athletic season.~   "
19830|NCT03307421|"~     Comparison between a team debriefing with an instructor and a team debriefing without an~     instructor, on improving non-technical skills (TEAM score) after simulating a vital emergency~     in a multidisciplinary team as part of the initial training~   "
19831|NCT03307408|"~     Global prevalence of Non Alcoholic Fatty Liver Diseases (NAFLD) ranges from 22% to 28%.The~     spectrum of these hepatic abnormalities extends from isolated steatosis to steatohepatitis~     (Non Alcoholic Steato-Hepatitis, NASH) and steatofibrosis leading to cirrhosis and~     hepatocellular carcinoma. NAFLD is one of the main causes of cirrhosis and increases the risk~     of liver-related death and hepatocellular carcinoma (developed in patients with or without~     cirrhosis). Despite this major public health concern, apart from lifestyle changes, treatment~     of NAFLD is still elusive as there is lack of efficacious pharmacological treatment.~     Alcoholic liver diseases are also frequent in Western countries. Alcoholic liver diseases and~     NAFLD share common pathological lesions and molecular pathways. This is illustrated by the~     emerging role of abnormalities of the microbiota (dysbiosis) in these 2 diseases leading to~     the concept of  liver-gut axis . Whereas the molecular mechanisms responsible for the~     progression from a safety state to NASH or to a severe alcoholic steato-hepatitis are still~     unclear, hepatic inflammation is a key factor involved in the progression of NAFLD and~     alcoholic liver disease.~      The hypothesis is that cellular and molecular abnormalities and gut dysbiosis could be~     present in patients with simple steatosis or with steato-hepatitis and could be responsible~     for the occurrence of hepatocellular carcinoma particularly without cirrhosis.~      The main objective is to compare cellular and inflammatory pathways in liver with and without~     hepatocellular carcinoma in patients with alcoholic or non-alcoholic fatty liver diseases.~   "
19832|NCT03307395|"~     Middle meningeal artery (MMA) embolization via a minimally invasive endovascular approach has~     been attempted with the goal of eliminating the arterial supply to the vascularized membrane.~     The investigators have recently presented the first known case series of MMA embolization as~     upfront treatment for cSDH in lieu of surgical evacuation (publication pending). Five~     patients underwent successful embolization of the MMA with subsequent reduction in size or~     complete resolution of cSDH with no peri-procedural complications.~      The purpose of this study will be to evaluate the safety and efficacy of MMA embolization~     compared to traditional surgical management for symptomatic, chronic, and medically~     refractory SDH. MMA embolization is an established procedure used routinely for treatment of~     tumors or vascular malformations; this study investigates the use of an established procedure~     for a new disease. The investigators hypothesize that MMA embolization will afford a~     particularly fragile patient population an alternative to invasive and morbid neurosurgical~     intervention.~   "
19833|NCT03307382|"~     Differentiation between malignant and benign biliary strictures can be challenging. Accurate~     differentiation of malignant biliary strictures from benign ones is crucial to guide~     management decisions.~      While conventional tissue acquisition techniques such as brush cytology or intraductal biopsy~     of the biliary stricture is often performed during ERCP for tissue diagnosis, their~     sensitivities are suboptimal. The average sensitivities for brush cytology and intraductal~     biopsy were reported to be ~ 59% and ~ 63% respectively.~      When the cause of a biliary stricture remains unclear despite conventional ERCP techniques~     for diagnosis, cholangioscopy is often performed during ERCP to clarify the diagnosis. This~     allows an endoscopist to obtain a visual impression (VI) and to perform targeted biopsy under~     direct visualization of the biliary stricture.~      Recently, a digital SOC system (SpyGlass Digital System (SpyGlass DS), Boston Scientific,~     USA) has become available and has the potential to further improve the diagnosis of malignant~     and benign biliary strictures. The utility of this digital SOC in the evaluation of biliary~     strictures has not been well studied. We propose this study to evaluate the utility of the~     digital SOC during ERCP in the diagnosis of malignant and benign biliary strictures.~   "
19834|NCT03307369|"~     Historically, Plasmodium vivax has been termed benign due to its non-life threatening~     clinical course and since the 1800's this view has been cultivated as demonstrated by the use~     of the term benign tertian malaria to describe the infection.However over the last 15~     years, more severe P. vivax malaria is being reported, causing concern that severe P. vivax~     malaria is under diagnosed. The definition of severe P. vivax malaria borrows from P.~     falciparum and is primarily one of exclusion. Species PCR (polymerase chain reaction) is the~     only way to prove P. vivax mono-infection but is expensive and requires skilled staff and~     technology. In resource constrained settings, diagnostic testing is not available for~     detection of most non-malarial infections further affecting the ability to determine whether~     severe symptoms are due to P. vivax malarial infection or a concomitant one.~      Retrospective studies from India, Pakistan, Indonesia, Papua New Guinea and Sudan support the~     existence of severe P. vivax malaria. However, inconsistent methodologies, definitions of~     severity, and use of diagnostic tests to exclude concomitant infection do not allow for~     standardised assessments for severe P. vivax infection across studies. A review by Baird,~     highlighted that the risk of being classed as suffering from severe illness was only~     minimally higher in P. falciparum than in P. vivax, but was unable to combine the data as a~     meta-analysis. The primary reported symptoms for severe P. vivax included severe anaemia~     particularly in children, severe thrombocytopaenia, respiratory distress, neurological~     syndromes (coma or seizures), renal and hepatic failure.~      Prospective studies have shown similar results. Tjitra et al showed that 23% (675 of 2,937)~     patients admitted with microscopically diagnosed P. vivax infections in Papua, Indonesia had~     severe disease and that the risk of severe malaria was significantly higher when admitted~     with P. vivax than with P. falciparum. In studies from Papua New Guinea, few differences~     between the clinical presentation of P. falciparum and P. vivax were found in children with~     severe malaria. This appears to be similar in populations from Sudan, Pakistan and India. In~     contrast, in Thailand, anecdotal observations note a low prevalence of severe P. vivax~     infections.~      The WHO criteria to assess severe P. falciparum have been extrapolated to P. vivax. In the~     2015 WHO malaria guidelines some criteria now account for P. vivax, such as removing a~     minimum parasitaemia when assessing for severe anaemia. Whilst these criteria may not be the~     most sensitive tool to define severe P. vivax infections, it is used for this purpose. It has~     been suggested that additional clinical information may be necessary to define truly severe~     P. vivax cases.~      In order to describe the characteristics of the severity of P. vivax infections in~     north-western Thailand, we will perform a retrospective review of annual reports of the~     outpatient database, the inpatient database and eligible inpatient medical records from 2001~     to 2016. The WHO malaria guidelines and additional clinical information will be used to~     assess the severity of infection and thus, a rate of severe P. vivax can be determined.~   "
19835|NCT03307356|"~     Options for childbearing are limited for the thousands of women in the United States who~     suffer from absolute uterine factor infertility. Uterine transplantation is an emerging~     treatment that provides hope for these individuals.~      In the Penn UNTIL trial, the investigators propose to successfully achieve live birth after~     uterus transplantation from deceased donors. The investigators plan to transplant five women~     who will ultimately undergo embryo transfer, pregnancy, delivery, and then transplant~     removal.~      The Penn UNTIL trial is divided into two distinct phases. In Phase I, study subjects are~     screened, enrolled, evaluated, generate embryos, and ultimately undergo uterine~     transplantation. This phase of the trial is a feasibility study whose primary outcome is~     successful transplant of a uterus from a deceased donor into a living recipient. In Phase II,~     women with successful deceased donor uterine transplants will have embryos implanted to~     ultimately attain the objective of live birth. This trial promises to expand the benefits of~     transplantation to a novel group of individuals who have a devastating diagnosis.~      For more information please visit:~     https://clinicalresearch.itmat.upenn.edu/clinicaltrial/4821/congenital-abnormalitiesfemale-in~     fertility-penn-ut/~   "
19836|NCT03307343|"~     This is a 2-arm, 3-month randomized trial comparing a novel sedentary behavior intervention~     vs. control in working adults (n=300). The primary outcome is resting systolic blood pressure~     (SBP) at 3 months; secondary outcomes will be resting diastolic blood pressure (DBP),~     ambulatory blood pressure (ABP), and carotid-femoral pulse wave velocity (cfPWV). Also, best~     practice objective activity monitoring will be leveraged in the analysis of ABP to account~     for recent activity and posture and will inform adherence and dose-response relationships.We~     will also measure plasma renin activity and aldosterone as a potential mechanism of blood~     pressure reduction, and insulin and glucose as exploratory outcomes.~   "
19837|NCT03307330|"~     Studies show that sleep apnea increases the risk of cardiovascular disease and is associated~     with obesity. However, it is unclear how sleep apnea affects fat tissue. Studies have shown~     that fat tissue is likely involved in developing cardiovascular disease. The purpose of this~     study is to see how sleep apnea changes fat tissue.~   "
19838|NCT03307317|"~     Background:~      People show changes in brain activity when they watch other people do actions. This may be~     part of early social and communication skills. Researchers want to understand the stages of~     normal development of motor observation and imitation in people and how it relates to social~     development in infants and toddlers.~      Objective:~      To study the nature of brain activity that underlies typical brain functioning in infants,~     toddlers, and adults.~      Eligibility:~      Infants ages 9 12 months~      Healthy adults ages 18 65~      Design:~      Adult participants will have one visit. They will:~      Answer questions about their family, like its size and ethnicity.~      Answer questions about their own behavior and do a simple motor task.~      Have EEG/fNIRS. A damp elastic cap with small sensors will be placed on the head.~     Participants will observe stimuli, either on a video screen or of a live person. The sensors~     will be connected to a computer. That will record the participant s brain activity while~     watching pictures on a screen.~      Infant participants will have 2 visits.~      Their parents will answer questions about their family.~      The parents will fill out forms about their child s development. These will be mailed to them~     before each visit.~      Parents will stay with their infant while study staff does an assessment of the child s~     communication, motor, and thinking skills.~      Infants will have EEG/fNIRS.~      Infants who are at risk for developmental delays will come back for another visit when they~     are about 2 years old. This will repeat the infant visits but it will not include EEG/fNIRS.~      Some questionnaires and assessments will be videotaped.~   "
19839|NCT03307304|"~     Background:~      CLN3, or Batten disease, is a genetic disorder. This deadly disease leads to decline of brain~     and nervous system functions. Symptoms of CLN3 typically occur between 4 and 7 years of age.~     They include changes in how a person sees, thinks, and moves. CLN3 can also cause seizures.~     No effective treatments for the disease are yet known. There is limited testing of potential~     therapies. Researchers want to study CLN3 more so they can improve future therapies.~      Objective:~      To identify clinical or biochemical markers that can be used as therapeutic outcome measures~     for CLN3.~      Eligibility:~      People with CLN3. It must be based on~      Two CLN3 mutations OR~      One CLN3 mutation AND findings seen with a powerful microscope~      Family members of a person with CLN3.~      Design:~      Participants will have already been referred to NIH for CLN3 evaluation.~      If participants agree to do the study, they will:~        1. give spinal fluid, blood, urine, and skin samples. They may provide other samples if~          they were already collected. These may include cells, surgical specimens, and DNA.~        2. will be seen by multiple healthcare specialists.~      Participants may provide medical records or photos. Participants will sign a release of~     medical records form.P~      Researchers may send samples or clinical data to other investigators. For research testing,~     the samples will not include the participant s name. For a test in a clinical lab,~     researchers will include the participant s name. These results will become part of the~     clinical record at NIH.~   "
19840|NCT03307278|"~     In this project, PBMCs will be isolated from HDM allergic and non allergic patient and then~     stimulated with HDM crude extract. The expression of inflammasome and the correlation of~     inflammasome activation and steroid resistance will be investigated.~   "
19841|NCT03307265|"~     The aim of the study is to test whether wearing a weighted jacket can help improve the~     balance distortion of patients with neurologic pathologies.~      The center of mass of the patient will be analyzed in order to determine the direction in~     which the imbalance is most important. Weights will be placed accordingly in a jacket in~     order to correct the imbalance. In the experimental group, weights will represent 1.5 to 2%~     of the patient body mass. In the control group, the investigators will use weights of 200~     grams maximum, placed evenly on both sides of the jacket. Patients will wear the jacket for 2~     consecutive hours.~      After wearing the jacket for 2 hours, data similar to those recorded at the beginning of the~     experiment will be taken again, namely the determination of the center of mass and of the~     deviations caused by the imbalance.~      A final series of tests will take place approximately one week after wearing the jacket, to~     determine if there are any residual effects.~   "
19842|NCT03307252|"~     The primary objective of this trial is to investigate the relative bioavailabilities of~     digoxin, furosemide, metformin and rosuvastatin given as a cocktail alone and as a cocktail~     together with the following drug transporter inhibitors:~      Part 1: verapamil (P-gp) and rifampin (OATP1B1/1B3) Part 2: cimetidine (OCT2/MATE) Part 3:~     probenecid (OAT1/3) The secondary objective is to investigate other potential changes in~     pharmacokinetics (e.g. in clearance, volume of distribution, etc.) of digoxin, furosemide,~     metformin and rosuvastatin given as a cocktail alone and as a cocktail together with the~     inhibitors describe above.~   "
19843|NCT03307239|"~     Abstract Objectives: Use of analgesics is the most common method to alleviate the pain~     induced by chest tube removal (CTR), but patient response to medication can vary and may not~     be achieved complete relaxation. This study was to determine the effectiveness of cold~     application in combination with standard analgesic administration before CTR on CTR-induced~     pain.~      Methods: A prospective, randomized, single-blind, placebo sham-controlled study was~     conducted. In addition to the same routine care, subjects in the experimental group (n = 30)~     received cold application of 600 g ice packs 15 minutes before CTR, whereas subjects in the~     placebo sham group (n = 30) received tap water packs. Numerical rating scale was used to~     measured pain intensity before, immediately after, and 10 minutes after CTR.~   "
19844|NCT03307226|"~     This study examines the impact and cost associated with Suubi4Her, an innovative combination~     intervention that aims to prevent HIV risk behaviors among 15-17 year-old girls living in~     communities heavily affected by poverty and HIV/AIDS in Uganda. Participants will be randomly~     assigned at the school level into one of three study conditions: 1) Savings (Youth~     Development Accounts - YDA) - with a 1:1 incentive match rate - for education and~     microenterprise development; 2) Savings (YDA) + Multiple Family Groups intervention; 3)~     Control condition receiving standard health and sex education provided in schools. The~     intervention will last for 24 months. Assessments will be conducted at baseline, 12, 24 and~     36 months. Assessments will include biologically confirmed STIs, proportion of HIV infections~     during the study period, and for HIV+ participants markers for ART adherence. The study aims~     to examine the impact of the Suubi4Her intervention on behavioral health functioning, and~     protecting adolescent girls against known HIV risk factors. The study will also examine the~     cost-effectiveness of each intervention condition.~   "
19845|NCT03307213|"~     This study aims to demonstrate that the BioFreedom™ Cobalt Chromium Drug Coated Stent is~     non-inferior to the market authorized BioFreedom™ Stainless Steel Stent with respective to~     efficacy and shows a similar safety profile.~   "
19846|NCT03307200|"~     Nowadays, high-quality cancer care is more than just diagnosis and treatment of cancer.~     Healthcare must respond to the specific needs of the patients to provide patient-centered~     care. To date, research on the unmet supportive care needs in bladder cancer patients~     undergoing radical cystectomy is scarce. Because the needs of the patients may differ~     according to the phase in the illness trajectory, it is important that prospective research~     is carried out. Research in other cancer populations shows that unmet supportive care needs~     are negatively associated with health-related quality of life, psychological distress,~     physical activity and the health literacy of the patient. By incorporating the above factors~     into this study, we can not only map the unmet supportive care needs of the patient, but also~     explore possible associations between the variables. Since this is the first prospective~     study on supportive care needs in bladder cancer, this is a hypothesis-generating study.~   "
19847|NCT03307187|"~     This study tested the effectiveness of the Group Lifestyle Balance™ (GLB) program adapted~     specifically for people with impaired mobility using standard behavioral approaches for~     weight loss. The overarching aim of this study was to promote health and reduce chronic~     disease risk among people with mobility impairment by building an evidence base for weight~     loss. The central hypothesis was that participants randomized to the intervention arm of the~     adapted GLB would show significant improvements on primary outcomes of weight and PA compared~     to a 6-month wait-list control group at 3 and 6 months, and show improvements on several~     secondary health outcomes.~   "
19848|NCT03307174|"~     Epidurals are an effective means for providing neuraxial anesthesia and analgesia. Prior~     studies in labor epidurals have demonstrated that a programmed intermittent bolus application~     of local anesthesia can improve pain control by reducing the amount of local anesthetic~     required as well as improve patient satisfaction when compared to continuous epidural~     infusions. The effects of programmed intermittent bolus of epidural local anesthetics~     compared to continuous epidural infusions in a surgical setting have yet to be elucidated.~     Our goal is to evaluate the use of programmed intermittent bolus compared to continuous~     epidural infusion in a surgical patient population. We plan to enroll patients already~     undergoing abdominal surgeries including colorectal, gynecologic, surgical oncology,~     urological where epidural anesthesia can be employed. The primary endpoints of the study will~     be the total local anesthetic consumption and total opioid consumption as surrogate markers~     for the quality of epidural anesthesia. Secondary endpoints are pain scores and functional~     measurements, patient satisfaction, and incidence of hypotension.~   "
19849|NCT03307161|"~     In this study, we will determine if posture and heart rate variability will significantly~     improve in Parkinsons disease with camptocormia after osteopathic manual treatments dystonia.~   "
19888|NCT03306654|"~     Participants will be randomly assigned between three well-being programs, and assessed with~     questionnaires before and after the 8-week program, as well as 1-month after the end of the~     program.~   "
19850|NCT03307148|"~     Pancreatic cancer (PDAC) is the fourth highest cancer killer worldwide and is responsible for~     6% of cancer deaths. Around 80% of patients are diagnosed at a late stage when cancer has~     spread and surgical removal is no longer possible. At present there are no treatments~     available which will shrink the tumour to enable surgical removal.~      A main factor in the lack of treatment options for patients is that pancreatic cancer is~     surrounded by a thick scar tissue called the stroma, which forms a barrier to prevent~     chemotherapy from entering and shrinking the tumour. Research carried out in laboratories has~     shown that a derivative of Vitamin A, All Trans Retinoic Acid (ATRA), may have the ability to~     break down this stroma allowing chemotherapy to reach the cancer.~      STAR_PAC will test the combination of ATRA with two chemotherapy drugs; Gemcitabine and~     Nab-Paclitaxel in patients with locally advanced or metastatic pancreatic cancer. There are~     two parts to the study; the first will test different doses of the drugs on around 24~     patients to find the highest dose patients can take without too many side effects. The second~     part will test this dose on around 10 patients to find the dose that will produce the desired~     effect with limited side effects. Patients will take ATRA for up to 6 cycles and chemotherapy~     until their cancer worsens and will be followed up for 12 months. The study will also explore~     the ability of a type of scan, DW-MRI, to detect changes in the cancer (optional for~     patients). Patients can also opt to donate additional tumour samples (biopsies) and normal~     cell samples (cheek cells and hair samples).~      Eligible patients will be recruited through NHS Clinics and should have histologically~     confirmed locally advanced or metastatic pancreatic cancer according to RECIST criteria and~     must have received no prior treatment for this cancer.~   "
19851|NCT03307135|"~     Spasticity is a disorder of the muscular tonus that occurs in disease including the upper~     motor neuron (strokes, spinal cord injuries, multiple sclerosis, traumatic brain injuries or~     cerebral palsies). It begins few hours after the neural aggression and last until the grave.~      The most accepted definition refers to a velocity-dependent increase in stretch reflexes~     elicited by passive stretch (Lance definition) but new approaches prefers to distinguish~     neural (reflex) and non-neural (soft tissues alterations) components of the increase~     resistance to a passive stretch. This deficiency is a major cause of complications as walking~     impairment, pain or bone deformities and may require intensive therapies (intrathecal~     baclofen infusion, intramuscular toxin botulinium injection, surgery, etc). Despite its high~     frequency and the potential complications, only clinical scales (modified Ashworth scale and~     modified Tardieu scale essentially) with criticized metrological properties are available for~     daily assessment. The SPASM Consortium has published on 2005 recommendations for developing~     devices using both mechanical and electrophysiological parameters. The principle challenge~     was to ally parameters accuracy and utilization facility allowing quickly evaluation to the~     patient's bed. Few research team works on this topic but mostly on specific population and~     nowadays, no device has really crossed the door of laboratories.~      This kind of tool would help us to improve the quality of the follow-up and to guide us~     between the choices of specific therapies.~      The MSPMI has been created following these recommendations in the University of Technology of~     Compiègne, thanks to the collaboration between researchers of the UMR 7338 CNRS and a brain~     surgeon of the Nantes University Hospital. The patent was obtained on 2012. This device~     allows the assessment of the ankle plantar extensor (triceps surae) during a manually applied~     stretch movement. This muscle was selected as it is frequently involved and treated for~     spasticity.~      This study aims to evaluate the metrological properties of the MSPMI (reliabilities,~     responsiveness, known group validity, construct validity, measurement errors and internal~     consistency) among a large cohort of patients with no restriction of etiologies recruited in~     the Nantes University Hospital.~   "
19852|NCT03307122|"~     Prospective, double-blind, randomized study of 2 infant formulas.~   "
19853|NCT03307109|"~     Bone and joint infections (BJI) are rare serious pathology which can lead to a very heavy~     handicap and sometimes to the life threatening. These are devastating diseases whose~     diagnosis is difficult. They are known to be associated with high mortality rates (5%) and~     significant morbidities responsible for functional sequelae (40% of patients) with an~     individual cost (prolonged hospitalization, altered quality of life) and societal (work~     stoppage, partial or total disability, temporary or permanent) extremely high.~      These bone and joint infections have a significant impact on the quality of life of those~     affected who, in addition to their infection, are reduced in their autonomy and often need to~     be taken care of outside their home, sometimes away from home.~      To the knowledge of investigators, there are few studies on the measurement of quality of~     life in patients with osteoarticular infection.~      The aim of this study is to implement the EQ-5D-3L validated quality of life questionnaire~     and the EVA scale (created by EuroQol Group) for each patient with a prosthetic joint~     infection (IPA) on prosthesis during their medical care in the department of Infectious and~     Tropical Diseases.~   "
19854|NCT03307096|"~     This is a prospect, randomized control trial to evaluate merits between microperc and FURS~     for lower pole renal stone~   "
19855|NCT03307083|"~     Various studies showed how extent elements not directly linked to the state of the patient~     were involved in the failures in particular in surgery. That's why it's common to use check~     list system to avoid human mistakes or any other situation which could impact on the surgery.~      Here the study 's aim is to assess a tool set up by the Foundation for Oral Rehabilitation ;~     it's a check list which cover all the treatment phases concerning dental implant surgery.~   "
19856|NCT03307070|"~     The first aim of this study is to develop a structured, cognitive behavioral treatment manual~     for major depressive disorder (MDD) adapted for individuals with moderate to severe traumatic~     brain injury (TBI) (CBTx-TBI), as well as evaluate its acceptability and tolerability in an~     open 12-week pilot trial (N=10).~      The second aim is to evaluate the acceptability and tolerability of, and adherence to,~     CBTx-TBI in a randomized waitlist-controlled, 12-week pilot trial (N=40).~      A third, exploratory aim is to evaluate the potential efficacy of CBTx-TBI for MDD in the~     randomized pilot trial (N=40) and possible moderators and mediators of outcome.~   "
19857|NCT03307057|"~     This early treatment project is designed to address two significant public health challenges~     - the need for validated, manualized, treatments for young children with Autism Spectrum~     Disorder (ASD) that are cost-efficient and feasible for community-based implementation, and~     the need to reduce the age of entry into early intervention to optimize outcomes. This study~     will use a 2-stage sequential multiple assignment randomized trial (SMART) design to develop~     an adaptive intervention by comparing individual and combined effects of preventative parent~     education and autism treatment starting in infancy. All parent-infant dyads from the pool of~     250 high and low risk siblings in the Emory Autism Center of Excellence (ACE) will be invited~     at 6 months of age and randomly assigned at Stage 1 to the Social Communication Growth Charts~     (SCGC) that use an innovative web-based technology to teach parents early social~     communication milestones and how to support their child's development very early or Usual~     Care (UC), in order to compare the efficacy on developmental trajectories from 9 to 30~     months. Families of children who show early signs of ASD at 12 months of age based on~     tailoring variables using parent report and observational measures will be re-randomized at~     Stage 2 to compare efficacy of a parent-implemented (P-I) condition of a naturalistic~     developmental behavioral intervention (NDBI) based on the Early Social Interaction (ESI)1~     model to a clinician-implemented (C-I) condition of NDBI based on a hybrid model from 12 to~     21 months of age. The investigators anticipate that 80 children will show early signs of ASD~     and that 56 families (70%) will agree to participate in the Stage 2 treatment. Growth~     trajectories of parent contingent responsiveness and child social communication will be~     collected longitudinally with repeated measures at 9, 12, 16, 21, and 30 months. Outcome~     measures of autism symptoms, developmental level, and adaptive behavior will be examined at~     21 and 30 months to measure differential treatment effects.~   "
19858|NCT03307044|"~     This pilot clinical trial studies how well fraction carbon dioxide (CO2) laser therapy works~     in treating vaginal atrophy in patients with breast cancer. Fraction CO2 laser therapy uses~     intense beams of light to cut, burn, or destroy tissue and may remodel vaginal tissue and~     direct controlled thermal damage of vaginal mucosa.~   "
19859|NCT03307031|"~     The aim of the present study was to assess the influence of different volumes of Pilates~     training exercises on metabolic, blood pressure (BP), functional physical fitness (PF) and~     quality of life (QL) outcomes in postmenopausal dyslipidemic women. In total, 26 women~     participated in the controlled clinical trial, being allocated into three groups: high volume~     group (HVG; n=9), low volume group (LVG; n=11) and control group (CG, n=6). HVG performed~     four weekly sessions and LVG performed only twice a week, during 10 weeks with 45 to 55~     minutes per session. Before and after the intervention period, metabolic, BP, PF, QL and~     cardiovascular risk score (CRS) outcomes were measured. The results were described by mean~     values with lower and upper limits (95% confidence interval). Comparisons between groups and~     intra-groups were performed adopting Generalized Estimating Equations (GEE) method, with post~     hoc of Bonferroni and significance level of ɑ=0,05.~   "
19860|NCT03307018|"~     Respiratory complications are the largest group of complications following anatomical lung~     resections. Most of these complications result from a disrupted evacuation of respiratory~     secretions. At present, prevention of such complications involve: aspirating of secretions~     with a catheter during surgery through an intubation tube, active postoperative~     rehabilitation, mucolytic treatment and effective postoperative pain management. Suctioning~     of secretions by a catheter through an intubation tube does not, however, allow for removal~     of secretions from entire bronchial tree. Bronchofiberoscopy with a small-diameter flexible~     bronchoscope and thorough, systematic aspiration of secretions from respiratory tract~     immediately after surgery could presumably result in more effective bronchial cleansing and~     reduce risk of respiratory complications after surgery. Although the British Thoracic Society~     guidelines do not recommend routine bronchoscopy as a standard postoperative management after~     lung resections, they are based on a single, randomized, study analyzing a small group of~     patients. Bronchoscopy with systematic aspiration of secretions done with a thin flexible~     scope is a safe procedure, without risk of complications. It does not cause any additional~     discomfort to the patients and allows for much more accurate aspiration of the bronchial~     secretions than with a catheter inserted blindly through an intubation tube. It also gives an~     opportunity to directly evaluate segmental and subsegmental bronchial patency. This is~     particularly important in patients with COPD who tend to accumulate large amounts of mucus~     secretion in the bronchial tree.~   "
19861|NCT03307005|"~     Poor sleep quality is common in patients with heart failure. The limited available evidence~     intimates that improving sleep quality in patients with heart failure may improve morbidity~     and quality of life in this patient population. However, there is a paucity of evidence~     assessing the use of effective pharmacologic therapies in heart failure. The~     nonbenzodiazepine, GABA receptor agonist, zolpidem, has been found to have considerable~     benefits over traditional benzodiazepines as a soporific medication. The investigators~     hypothesize that zolpidem will safely improve sleep quality in patients with heart failure.~   "
19862|NCT03306992|"~     This is a Phase 3 study aimed at investigating the effects of a personalized exercise program~     (PEP) in NSCLC patients (stage I, II, IIIa) and secondary lung cancer patients undergoing~     surgical treatment at the University of Utah and comparing the intervention to the current~     standard of care (no exercise program).~   "
19863|NCT03306979|"~     This is a 24-week randomized, double-blind, placebo-controlled parallel group design study~     involving Vascular cognitive impairment-no dementia (VCIND) patients to evaluate the efficacy~     and safety of oral NAC supplementation (2,400 mg daily) as an add-on therapy to improve~     cognitive function in patients undergoing cardiac rehabilitation (CR). The CR program~     consists of a harmonized aerobic and resistance training in a supervised group setting.~     Eligible patients will be randomized to receive NAC (four 600 mg capsules given as 2 capsules~     in the morning and 2 capsules in the evening) or matching placebo capsules. The initial NAC~     dosage will be 600mg/day (one 600mg capsule in the morning) for the first week, followed by~     1,200 mg/day (one 600 mg capsule in the morning, one 600mg capsule in the evening) for the~     second week, followed by 1,800 mg/day (two 600mg capsules in the morning, one 600mg capsule~     in the evening) for third week, followed by 2,400mg/day (two 600mg capsules in the morning,~     two 600mg capsules in the evening) for the following 21 weeks.~   "
19864|NCT03306966|"~     The purpose of this observational study is to evaluate the safety and performance of the~     Single Use Endoscopic Linear Cutter Stapler and Reloads from Frankenman used in~     (hemi)colectomy to remove tumors and create anastomoses in patients with cancer in the~     ascending colon. The goal of the study will be achieved by assessing the device performance~     and reporting of peri- and postoperative complications in a prospectively maintained~     database.~   "
19865|NCT03306953|"~     This is a prospective randomized controlled study to determine the clinical outcome of rectus~     muscle re-approximation at Cesarean delivery.~   "
19866|NCT03306940|"~     Hemifacial spasm patients who received botulinum toxin A injection were divided into two~     groups. Group A received unilateral injection while group B received bilateral injection.~     Patients completed follow-up A researcher record facial videos and analyzed facial symmetry~     and completed 3 scales.~   "
19867|NCT03306927|"~     This study is part of a group of studies whose overall goal is to accurately define the~     physiochemical and structural effects of pea varieties and relate these to blood glucose~     attenuation and appetite related sensations in healthy human volunteers.~   "
19868|NCT03306914|"~     In this study we try to review the possible effects when using modern hydroxyethylstarch~     solutions 6 % versus albumin 5% during living donor renal transplantation.~   "
19869|NCT03306901|"~     This is a randomized noninferiority multicenter trial. Patients will be stratified according~     to the participating hospital. Patients will be randomized to one of the treatment arms.~      Arm A: Patients will receive surgical resection, including Ivor Lewis esophagectomy or~     McKeown esophagectomy and systematic lymphadenectomy.~      Arm B: Patients will receive 5-fluorouracil (5-FU) and cisplatin-based chemotherapy~     concurrently with radiotherapy. Patients will receive cisplatin (60mg/m2) intravenously over~     1 hour on day 1 and receive 5-FU (3,200 ~ 4,000mg/m2) intravenously for 4 to 5 days.~     Treatment will repeat every 3 weeks for 2 courses. Patients will receive a total of 45 Gy~     irradiation (5 days a week for 5 weeks).~      Patients will be followed at 3 and 6 months after randomization, then every 6 months for~     following 2 and half years (up to 3 years after randomization), and 4 and 5 years after~     randomization.~   "
19871|NCT03306875|"~     This study aims to apply baseline MRI and neuropsychological measures to predict patient~     responses to behavioral cognitive rehabilitation. Training will take place over 12 weeks, 1~     hour per day, 5 days per week.~      The investigator hypothesizes the following:~      [1a] The investigator expects that individuals with low baseline Conscientiousness will~     experience a lower magnitude of overall cognitive improvement following rehabilitation~        1. b] The investigator expects the impact of Conscientiousness on fidelity of~          rehabilitation will in part be moderated by individual differences in program adherence~          and executive function~        2. a] The investigator expects that individual differences in structural and functional~          connectome disturbances will in part explain differences in participant responses to~          cognitive rehabilitation.~      This study will also serve to supplement the sample of participants for the current IRB~     approved study ((IRB: 603069, Title: A case-control, 5-year follow-up study of~     cardiovascular, environmental and genetic risk factors for disease progression in patients~     with multiple sclerosis.~   "
19872|NCT03306862|"~     This study is part of a group of studies whose overall goal is to accurately define the~     physiochemical and structural effects of pea varieties and relate these to blood glucose~     attenuation in healthy human volunteers.~   "
19873|NCT03306849|"~     The investigators would like to determine whether ultrasound features of the ovaries can be~     used to reliably diagnose different types of anovulatory disorders in women across all body~     types. The study will also try to establish whether ultrasound features of the ovary can~     reflect the degree of reproductive and metabolic problems that a woman with irregular or~     absent periods might be experiencing.~   "
19874|NCT03306836|"~     In the stage of randomized controlled study, our purpose is to obtain the Intraoperative~     anticoagulation program supported by evidence-based medicine.~   "
19875|NCT03306823|"~     In the stage of registration study, our purpose is to find out the safety range of activated~     coagulation time level in cerebral aneurysm and arteriovenous malformations with hybrid~     operation.~   "
19876|NCT03306810|"~     AGS (Acute Glucose Service ) is an inpatient glucose management service consisting of Nurse~     Practitioner and physician. Team manages not - consulted- based preoperative assessment,~     perioperative glucose control, patient education and supervision, but also transition of care~     postoperatively. The goal is to detect and treat dysglycemias , but also provide an active~     and constantly ongoing education to other hospital teams.~      AGS improves better overall- survival of arthroplastic patients and is an effective way to~     recognize and treat dysglycemias and to organize constantly ongoing education.~   "
19877|NCT03306797|"~     The study uses a specific hand tracking sensor (Leap Motion Controller) to catch the~     movements of the arm combined with proper pre-defined musical patterns (sonification) in a~     neurologic music therapy perspective. The aim of the experiment is to verify the efficacy of~     sonification technique (compared to usual care) in the hand rehabilitation of patients with~     stroke.~   "
19878|NCT03306784|"~     Fulfilling by all patients consequently seen by 6 rheumatologists in a same outpatient~     rheumatology clinic (in at least one month period) of a set of 6 questionnaires, including~     RAPID3 and pain catastrophizing scales.~   "
19879|NCT03306771|"~     The correlation between metabolic syndrome and carotid artery stenosis is well established.~     The purpose of this study is to evaluate the relationship between morbid obesity and carotid~     artery stenosis.~   "
19880|NCT03306758|"~     This study evaluate the serum uric acid lowering effect of sodium bicarbonate as well as its~     safety in patients with asymptomatic hyperuricemia or gout. Half of the participants will~     receive sodium bicarbonate only, while the other half receive none.~   "
19881|NCT03306745|"~     The role of micronutrients in fertility has recently gained increased attention. In women who~     suffer from polycystic ovary syndrome (PCOS) and infertility, we aim to test the impact of a~     standardized, multinutrient supplementation on the course of PCOS-specific parameters namely~     anti-Mullerian hormone (AMH), testosterone, and androstenedione. A total of 60 infertile~     women with PCOS, previously untreated, will be randomized to receive either a combined~     standardized multinutrient supplementation (containing folic acid, selenium, vitamin E,~     catechins, glycyrrhizin, coenzyme Q10 and omega-3-fatty acids; study group) or folic acid~     alone (control group) in a double-blinded, randomized manner. These study medications will be~     provided for 3 months and pre- to posttreatment levels of AMH, testosterone, and AMH will be~     analysed. The study will be performed at the Clinical Division of Gynecologic Endocrinology~     and Reproductive Medicine of the Medical University of Vienna.~   "
19882|NCT03306732|"~     This pilot trial will evaluate the ability of thiamine to affect on postoperative vasoplegia~     in high risk cardiac surgery patients~   "
19883|NCT03306719|"~     Finding a predictive biomarker for IAI could improve the clinical outcome for the mother and~     the neonate. The aim of this study is to quantify the copy number of circulating cell-free~     mitochondrial DNA in maternal serum and the placenta compared to controls.the investigators~     hypothesise that circulating cell-free mitochondrial DNA levels could help predict the~     likelihood of early inflammation in IAI. In addition, mitochondrial DNA could be a promotor~     triggering the pathogenesis of systemic inflammation.~   "
19884|NCT03306706|"~     This study is part of a group of studies whose overall goal is to accurately define the~     physiochemical and structural effects of pea varieties and relate these to blood glucose~     attenuation and appetite related sensations in healthy human volunteers.~   "
19885|NCT03306693|"~     The aim of this study is to test whether a short educational intervention about emotional~     skills can improve survivor cancer patient emotional skills and quality of life. Half of~     participants will follow the educational intervention about emotional skills, while the other~     half will practice relaxation followed by a non-directive talking group. The educational~     intervention should give better results on patient emotional skills and quality of life than~     the control group.~   "
19886|NCT03306680|"~     This multi-centre phase I dose-escalation study will use a time-to-event continual~     reassessment method (TIT-CRM).~      Accrual will start at level 1 (60 Gy in 8 fractions). Patients will be assigned to treatment~     doses using the TITE-CRM model. The model will use all available information from previously~     accrued patients to assign the highest dose with a predicted risk of grade 3 toxicity of 30%~     or less.~   "
19887|NCT03306667|"~     The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety~     after single oral administration of FYU-981 to subjects with hepatic insufficiency and with~     normal hepatic function.~   "
19890|NCT03306615|"~     Double blind, randomized, placebo-controlled trial of human recombinant hyaluronidase~     injections in individuals with post-stroke upper limb muscle stiffness. Fifty individuals~     with post-stroke hemiparesis, with moderately-severe muscle stiffness, between 6 months and 3~     years will be randomized to receive either hyaluronidase plus saline (treatment arm, n=25) or~     normal saline (control arm, n=25) injections. Both the assessors and the patients will be~     blind to group assignment. All patients will be assessed at three time points: (1)~     pre-injection, (2) 1-2 weeks post-injection, and (3) 12-14 weeks post-injection. Assessments~     will be performed pre-injection and 1-2 weeks post-injection for joint range of motion,~     muscle strength by EMG MVC, upper limb motor impairment and function, stretch reflex testing,~     shear wave elastography, and muscle MRI, and 12-14 weeks post-injection for all assessments~     except muscle MRI~   "
19891|NCT03306602|"~     The aim of this study is to evaluate the clinical performance of Filtek Bulk Fill Posterior~     Restorative in Class I and Class II restorations compared to the conventional incremental~     technique using Filtek Z350XT over the period of 2 years. The null hypothesis of this study~     is that the bulk-fill composite will exhibit same result and clinical performance as~     conventional composite using incremental technique which has been used widely by dentists~     nowadays.~   "
19892|NCT03306589|"~     This exploratory study aims to assess exposure of healthy subjects to systemic challenge with~     either LPS or GM-CSF. This will be done by measuring inflammatory mediators and cellular~     activation markers both in circulation and in skin blisters induced by exposure to~     cantharidin (an agent that causes blisters). LPS is often used to induce inflammation whereas~     GM-CSF is a cytokine and a key mediator in inflammatory diseases. In this 2 parts study,~     subjects will have 2 sessions in each part. Part I of the study is a dose-exploration phase~     and part II will be a continuation phase to draw more precise outcomes. In session 1,~     subjects will be randomized to receive either LPS or GM-CSF and will have 2 blisters induced~     on each forearm followed by blood draws and a blister harvest on each forearm at 24 and 48~     hours post-induction. After a minimum of 14 days blister healing period, subjects will return~     for session 2. In part I, Up to 6 cohorts will be tested and all cohorts will have 2~     sessions. For Part I, initially Cohort 1 will proceed with session 1. After their blister~     healing period, Cohort 1 will return for their session 2 visit in two groups (Group A and~     Group B) on different days. Group A will be dosed on the same day (one with LPS and one with~     GM-CSF) and Group B will be dosed on a different day (one with LPS and one with GM-CSF) after~     group A. Dose-escalation in Cohort 2-6 will be continued until the well tolerated dose has~     been determined. The same dose will be administered to an additional Cohort in Part II and~     the same 2-session design will be used. Approximately 24-30 healthy subjects will be enrolled~     for the study and the total duration of the study for each subject will be approximately 13~     weeks from screening to follow up.~   "
19893|NCT03306576|"~     Adhesive restorative materials are routinely used in operative dentistry to improve tooth~     tissues with minimal preparation, achieve more esthetic and long term restorations. Despite~     these efficacy to dentistry these materials still present some drawbacks like polymerization~     shrinkage. Postoperative sensitivity, marginal discoloration and possibly secondary caries~     are often associated with loss of marginal integrity in composite restorations occurred as a~     result of polymerization shrinkage. To achieve optimal long term performance, the~     requirements will be first to manage polymerization stress buildup following~     restoration.Low-shrinking composites with new formulas have been successful in brilliantly~     further developing the leader product els extra low shrinkage.~      The objective of this controlled clinical trial is to evaluate the clinical performance of~     restorative material ELS versus ELS Extra resin composite for Class I and Class II cavities~     that needs to be restored in permanent teeth.~   "
19894|NCT03306563|"~     The objective of the study is to confirm the clinical relevance of the novel biomarker for~     traumatic brain injury (TBI) detection. Samples of blood, urine and saliva will be collected~     from a) patients with suspected TBI (isolated), b) patients with orthopedic injury, and c)~     healthy controls. The sponsor will do biochemical investigations for the samples to evaluate~     the presence, level and structure of the targeted biomarker.~   "
19895|NCT03306550|"~     The combination of anti-platelet medicine treatment and Chinese traditional medicine (TCM)~     promoting blood circulation to removing blood stasis is widely used in treatment for~     cardiovascular disease. However, the material foundation, effective mechanism and drug-drug~     interaction is still not clear. In order to solve the puzzle of rational use of Joint~     application by TCM and Western Medicine(WM),investigators conduct a research on mechanism of~     drug-drug interaction between salvianolate injection and aspirin based on metabolic enzyme~     and PK-PD model. This clinical trial contain three groups, aspirin group, salvianolate~     injection group and combination (salvianolate injection+aspirin) group. Investigators collect~     blood samples at special time points during post-administration.Investigators have already~     find out the Salvianolate's pharmacokinetic characteristics in vivo and establish the~     biological sample-testing analysis method in previous research. Depending on these results,~     this clinical trial aim to explore the pharmacodynamics-pharmacokinetics(PK-PD)~     characteristics of combination with Salvianolate and aspirin through biomarkers, blood~     concentration. Finally clarify the TCM and WM material basis and mutual mechanism of drug~     interaction and guide reasonable clinical prescription.~   "
19896|NCT03306537|"~     The respiratory rate is an important parameter in clinical medicine. It is defined as the~     number of breaths per minute. Currently this is measured at the bedside in clinical practice~     by counting the breaths, however the gold standard for measuring this vital sign is the~     capnograph. For the patient, this involves wearing a tube in their nose and around their ears~     while trying to minimise their movement and talking so that the measurements can be taken.~      A new respiratory rate monitor, RespiraSense, is non-invasive and measures the respiratory~     rate by measuring the displacement between the ribs and abdomen. This research study is~     intended to validate that this technology is effective and accurate on people with a bigger~     body mass.~      Subjects with a BMI > 35 will be invited to participate should they meet all of the~     eligibility criteria. If patients agree to participate, following informed consent, subjects~     will be monitored for one hour with both the capnograph and RespiraSense measuring at the~     same time so their results can be compared~   "
19928|NCT03306121|"~     To see the effect of induction chemotherapy（TPF） followed by concurrent chemoradiotherapy~     versus concurrent chemoradiotherapy followed by adjuvant chemotherapy (PF) in treating~     patients with high risk nasopharyngeal carcinoma (NPC).~   "
19897|NCT03306524|"~     During neonatal mechanical ventilation inflating pressures, tidal volumes, and inflation and~     expiration times need to be set and adjusted to optimise oxygenation and carbon dioxide~     removal. The flow of gas into the ventilator circuit has a big effect on ventilation but is~     usually set to a constant value (~8 L/min) for all babies regardless of size or severity of~     illness, based on minimal research. High circuit flow may lead to lung damage and low flow to~     inadequate ventilation. The investigators recently developed a unique system to capture,~     record, analyse, and display ventilator data at high resolution over long periods. Using this~     the investigators will investigate, in within patient cross-over studies, how the level of~     gas flow affects ventilator parameters and ventilation, in two commonly used ventilation~     modes. The results will determine the lowest circuit flow that ventilates a baby safely and~     effectively. It will also provide preliminary data for a randomised trial.~   "
19898|NCT03306511|"~     Few studies indicate that sprint performance may be impaired in football players with a~     previous hamstring strain injury. This exploratory cross-sectional study aim to compare~     sprint performance between football players with and without a previous hamstring strain~     injury. The findings may elucidate potential indications of insufficient rehabilitation~     following a hamstring strain injury.~      Sprint performance data will be collected using the MySprint Iphone Application.~      Due to pragmatic reasons and the exploratory nature of this study the aim is to include~     players on a team level.~      Based on the prevalence of hamstring strain injuries the expected number of cases to be~     included are 10-20 football players with a previous hamstring strain injury, and a~     corresponding 80-90 number of healthy controls.~      No outcomes will be weighted (flat outcome structure).~   "
19899|NCT03306498|"~     This is study to investigate the plasma free amino acids profile in patients with~     decompensated liver cirrhosis and hepatic encephalopathy and its relation to the nutritional~     state of these patients.~        -  To investigate the plasma free amino acids relation to the nutritional state of patients~          with liver cirrhosis and hepatic encephalopathy.~        -  To determine the effectiveness, cost, cost-benefit and in-hospital prognosis of branched~          chain amino acid (BCAA) infusion as an adjuvant to conventional mainstay therapy in the~          treatment of hepatic encephalopathy due to liver cirrhosis.~        -  To determine the effectiveness of branched chain amino acid (BCAA) infusion on improving~          amino acid imbalance and Fischer ratio (Branched chain amino acids/Aromatic amino acids~          ratio).~   "
19900|NCT03306485|"~     Nine to 30% of the population suffers from gastro-esophageal reflux disease (GERD) -~     suggestive symptoms (heartburn, regurgitation, chest pain, chronic couch, sore throat).~     Proton pump inhibitor (PPI) is usually the first line treatment. However 20 to 60% of~     patients have persistent symptoms on proton pump inhibitor. Complementary examinations are~     then required to determine the cause of persistent symptoms (non compliance to treatment,~     persistent esophageal acid exposure despite proton pump inhibitor, non acid reflux, reflux~     hypersensitivity, functional symptoms, rumination syndrome…). The gold standard to detect~     reflux episodes in patients on proton pump inhibitor therapy is 24-h ambulatory esophageal~     pH-impedance monitoring. Esophageal High Resolution Impedance-Manometry might help to~     determine gastro-esophageal reflux disease mechanisms especially when performed post~     prandially. Further some publications demonstrated that the number of reflux episodes~     detected during the post prandial period might be well correlated to the total number of~     reflux episodes recorded during 24 h.~      The hypothesis of this study is that 1-hour post prandial esophageal High Resolution~     Impedance-Manometry might be useful to diagnose gastro-esophageal reflux disease and can~     replace in some instances 24-h esophageal pH-impedance monitoring. Therefore the aim is to~     compare the number of reflux episodes detected with esophageal High Resolution~     Impedance-Manometry performed during 1-h post prandial period to the total number of reflux~     episodes detected during 24-h ambulatory esophageal pH-impedance monitoring.~   "
19901|NCT03306472|"~     Around 75% of breast cancers are defined and driven by Oestrogen receptor alpha (ERα)~     transcriptional activity. Standard treatment is endocrine therapy however clinical outcomes~     vary considerably, and a proportion of women with early breast cancer driven by ERα~     transcriptional activity develop drug resistance, and relapse with incurable, metastatic~     disease.~      Historically, PR-positivity was viewed as just a passive consequence of a functional~     oestrogen receptor, and PR was established as a biomarker of ER functionality in breast~     cancer. However, recent preclinical discoveries have provided an alternative explanation to~     the previous over-simplistic assumption, providing new insights into progestogen action and~     functional 'cross-talk' between ER and PR in breast cancer. In the presence of agonist~     ligands, progesterone-activated PR causes rapid sequestration of ERa chromatin binding sites~     in breast cancer cells, resulting in a unique gene expression program that is associated with~     a good clinical outcomes. This highlights a potential therapeutic opportunity.~      The PIONEER trial will investigate the effect of combining megestrol acetate (a progesterone~     receptor agonist) and letrozole (an aromatase inhibitor) in post menopausal women with early~     breast cancer. This is a 'window of opportunity' study treating and observing patients in the~     two weeks prior to definitive surgery. Patients are randomised into one of three arms; one in~     which the patients receive Letrozole alone; one in which they will receive a combination of~     Letrozole and low dose Megestrol acetate and the third arm will receive Letrozole and high~     dose Megestrol acetate. This trial will be open to postmenopausal women with newly diagnosed,~     untreated ER-positive, HER2-negative, invasive primary breast cancer.~   "
19902|NCT03306459|"~     A prospective assessment of psychological characteristics, quality of life and sexuality in~     naïve patients.~   "
19903|NCT03306446|"~     This is a prospective, longitudinal, multicenter study conducted in a cohort of patients with~     early CD. This study will not change the patient/physician relationship.~   "
19904|NCT03306433|"~     This study will evaluate effectiveness of a urethane dimethacrylate (UDMA)-quaternary~     ammonium methacrylate (K18) resin (UDMA-K18) smooth surface sealant to prevent biofilm~     attachment to tooth surfaces thereby eliminating the possibility for the tooth to be~     demineralized. The hypothesis is that UDMA-K18 containing smooth surface sealant will be more~     effective at reducing enamel demineralization than the UDMA control or no treatment.~   "
19905|NCT03306420|"~     This is a Phase I, open-label study to determine the safety, tolerability, pharmacokinetic~     (PK), pharmacodynamics (PD), and preliminary antitumor activity of MS201408-0005A as single~     agent (Part IA only) and in combination with MS201408-0005C or MS201408-0005B (Part IB, Part~     IC).~   "
19906|NCT03306407|"~     Travelling to tropical and subtropical countries is a known risk factor for becoming~     colonized with extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae.~     Especially travellers returning from the Indian subcontinent show high colonization rates of~     up to almost 90%.~      While risk factors for becoming colonized have been identified in several studies, no~     preventive measure has been tested so far.~      One of the factors associated with becoming colonized while travelling is suffering from~     travellers' diarrhoea. Earlier studies looking at diarrhoea in childhood as well as school~     and/or work absenteeism because of diarrhoeal diseases have shown protective effects through~     good hand hygiene. Furthermore, a recent retrospective study has shown lower rates of~     travellers' diarrhoea in people using hand gel sanitizers. Improving hand hygiene in~     travellers through increased hand washing and the use of hand gel sanitizers might therefore~     not only decrease the rate of travellers' diarrhoea but the carriage rate with ESBL-producing~     Enterobacteriaceae as well. However, there is no prospective data available to prove the~     usefulness of such an intervention, neither in the prevention of travellers' diarrhoea nor in~     the prevention of colonization.~      In the current study, investigators plan to compare colonization rates with ESBL-producing~     Enterobacteriaceae in travellers receiving pre-travel advice on improved hand hygiene~     (including the use of hand gel sanitizers) with travelers receiving standard advice.~   "
19907|NCT03306394|"~     The purpose of this study is to collect additional safety and efficacy data during treatment~     with trifluridine / tipiracil in patients with a pretreated metastatic colorectal cancer~     (mCRC).~      Eligible patients may receive an early access to trifluridine / tipiracil through this~     clinical study until progression of disease, unacceptable toxicity, investigator decision,~     patient refusal or until market authorization or reimbursement has been granted by the~     relevant Authority of the country where that patient is treated or until trifluridine /~     tipiracil is available by a doctor's prescription or can be accessed from another source or~     Sponsor decision.~   "
19908|NCT03306381|"~     The aim of the present study is to research whether subjects with irritable bowel syndrome~     (IBS) display epigenetic/genetic changes or altered microbiota compared to a non-IBS control~     group. Further, we will investigate if these parameters as well as subjective IBS symptoms~     are affected by a 4-week long dietary intervention within the IBS patient group.~   "
19909|NCT03306368|"~     Opioid addiction among youth (including both adolescents and young adults) is a growing~     health problem with catastrophic consequences for young people and their families. The~     current opioid epidemic disproportionately affects youth. Furthermore, compared to adults,~     adolescents and young adults tend to have poorer engagement in and response to treatment than~     older adults. Relapse prevention medications are the clear standard of care for the treatment~     of opioid addiction in adults, but the evidence base for effectiveness including~     implementation is not well-established in youth, and concerns from the field emphasize poor~     adherence and retention. Further there is no consensus regarding models of care, psychosocial~     treatments and platforms for delivery of medications. Extended release naltrexone (XR-NTX)~     has proven effectiveness in adults and is a promising pharmacotherapy for youth, but the~     field needs further clarification of its optimal use and delivery in this target population,~     in the context of developmentally informed models of care. There is inadequate current~     capacity for specialty opioid specific treatment that integrates pharmacotherapy (relapse~     prevention medication) with psychosocial treatment in a context that is youth welcoming and~     family empowering.~   "
19910|NCT03306355|"~     Prospective, randomised, controlled, single-surgeon, single-center clinical study to compare~     the clinical outcomes of two trifocal IOLs with different material (hydrophobic and~     hydrophilic) from the same manufacturer. Implantation of the IOLs is bilaterally.~   "
19911|NCT03306342|"~     Prospective, controlled, single-surgeon, single-center post-market clinical follow up study~     to investigate the clinical outcomes of a hydrophobic trifocal IOL (PhysIOL POD F GF)~   "
19912|NCT03306329|"~     This is a randomized, double-blind, two-part placebo-controlled parallel group outpatient~     treatment study that will utilize standard Parkinson's Disease measures to evaluate the~     effect of DNS-7801~   "
19913|NCT03306316|"~     This is a double blinded, randomized, controlled trial of prebiotic in infants born between~     29 and 32 weeks gestational age. The investigators anticipate enrollment of 90 subjects in~     total and for the study to be completed in 18 months. The investigators anticipate collecting~     clinical data, anthropometrics, stool samples (requiring appropriate storage through~     analysis), salivary samples from mother and infant, discarded blood samples from baby after~     the standard care lab tests are done, a single, optional blood draw at the conclusion of the~     study, and subjecting infants to a neurodevelopmental survey at study completion.~      The overall goal of this study is to test prebiotic administration to human milk-fed infants~     who are >1000 gram to <1500 gram birthweight. The goal of this study will be addressed~     through one primary aim, a secondary aim, and exploratory aims, indicated below:~      Primary aim: Compare weight, length, and head circumference Z-score growth between the study~     and placebo groups.~      Secondary aim: Compare the time taken to achieve full feedings (135 mL/kg/day or more)~     between the study and placebo groups.~      Exploratory aim 1: Compare neurobehavior, as measured by the validated Neonatal intensive~     care unit Network Neurobehavioral Scale (NNNS), between the study and placebo groups.~      Exploratory aim 2: Compare fecal calprotectin levels to determine the impact of~     supplementation on reducing intestinal inflammation between the study and placebo groups.~      Exploratory aim 3: Compare fecal microbiome between the prebiotic and placebo groups, to~     determine whether there is a shift in microbial composition towards bifidobacteria and other~     microbes that are capable of metabolizing prebiotic.~   "
19914|NCT03306303|"~     ST-segment elevation myocardial infarction (STEMI) is an acute manifestation of coronary~     heart disease, remaining a frequent cause of death. A better understanding of risk factors~     and pathogenic mechanisms underlying STEMI may help improve the prognosis and life quality of~     these patients. Melatonin is the chief indoleamine produced by the pineal gland, and a~     well-known antioxidant and free radical scavenger. Basic studies have showed that melatonin~     is associated with myocardial infarction and heart failure. However, no study has evaluated~     whether melatonin is associated with adverse clinical outcomes in STEMI patients.~   "
25216|NCT03236948|"~     This is an individually randomised control trial to assess the effectiveness of a livelihoods~     and social empowerment intervention, delivered by Women for Women International, on married~     women's experiences of intimate partner violence in Afghanistan. It has a 22 month follow up.~   "
19915|NCT03306290|"~     Obesity is a pandemic problem in modern societies. Bariatric surgery (gastric by-pass and~     sleeve gastrectomy) has emerged as an efficient treatment to reduce morbidity and mortality~     related to obesity. Obesity and bariatric surgery are known to be risk factors of surgical~     site infections (SSI). The occurrence of SSI increases health cost and the duration of~     hospitalization. However, an appropriate antibiotic prophylaxis has been shown to reduce SSI.~     As recommended by several national societies, the antibiotic prophylaxis dose should be~     increased in the severely obese population. However, this recommendation lies on a low level~     of evidence. Besides, great disparities regarding obese patient antibiotic prophylaxis exist~     between countries and adequate doses are still not clearly defined. In France, for instance,~     the intravenous second generation cephalosporin CEFOXITIN is used for antibiotic prophylaxis~     in bariatric surgery at the initial loading dose of 4g (2-fold that of non-obese population)~     at the beginning of surgery.~      Obese patients have increased risk of under-dosage due to modification of their~     pharmacokinetics (fat/lean mass, distribution volume, renal clearance, etc.). Only few~     studies, all investigating a low amount of patients, evaluated the appropriateness of~     intraoperative antibiotic prophylaxis dosage of different betalactam and cephalosporin in the~     obese population. This population was more likely to be under-dosed.~      The aim of this study is to analyse the appropriateness of the reference dose of intravenous~     Cefoxitin used as antibiotic prophylaxis in severely obese patients undergoing bariatric~     surgery. This will be a 2-year prospective monocentric study held in the University Hospital~     of Nancy, France. A large group of obese patients (~300) will be included. Serial serum~     concentration measurements of Cefoxitin will be performed before, during, and at skin closure~     of the bariatric surgery. This study will give insights in pharmacokinetics of the antibiotic~     prophylaxis in the obese population and will help to determine the initial dosage and the~     optimal method for antibiotic prophylaxis administration.~   "
19916|NCT03306277|"~     Phase 3 pivotal US trial studying open-label intravenous administration of AVXS-101 in SMA~     Type 1 patients~   "
19917|NCT03306264|"~     Multicenter, randomized, open-label, crossover PK study of ASTX727 versus IV decitabine.~     Adult subjects who are candidates to receive IV decitabine will be randomized 1:1 to receive~     the ASTX727 tablet Daily×5 in Cycle 1 followed by IV decitabine 20 mg/m^2 Daily×5 in Cycle 2,~     or the converse order. After completion of PK studies during the first 2 treatment cycles,~     subjects will continue to receive treatment with ASTX727 from Cycle 3 onward (in 28-day~     cycles) until disease progression, unacceptable toxicity, or the subject discontinues~     treatment or withdraws from the study.~   "
19918|NCT03306251|"~     The purpose of this study is to provide a surveillance system to monitor changes in the rate~     of mother to child HIV transmission and preventive practices in France and especially to~     identify the occurrence of toxicity in children exposed perinatally to antiretroviral drugs.~   "
19919|NCT03306238|"~     This is a randomised controlled trial to evaluate safety and efficacy of two different port~     site entry techniques in laparoscopic renal surgery: open method (Hasson) and closed method~     (Veress). It will involve 300 adult patients undergoing elective laparoscopic renal surgery~     in Tallaght hospital under two Consultant urologists.~   "
19920|NCT03306225|"~     The infectious endocarditis is a grave infection the incidence of which is at present~     esteemed at 30-100 episodes by million inhabitants a year.~      This infection is marked with a heavy morbi-mortality.Preliminary studies seem to show an~     abnormally high death rate at the patients presenting an infectious endocarditis to~     streptococci with an inhibitive minimal concentration raised to the amoxicilline. The aim of~     the study is to describe the epidemiology and the clinical presentations of the patients~     presenting an endocarditis to streptococci~   "
19921|NCT03306212|"~     Spastic wrist flexion deformity is a very common problem in children with CP. Although serial~     casting (SC) is one of the commonly used interventions in addition to botulinum toxin A~     (BoNT-A) injections and physical therapy for spastic deformities of lower extremity of~     children with CP, there is limited data on SC in the upper extremity.~      In this prospective, randomized, controlled clinical trial in order to overcome the issues~     with patient compliance, side effects and combined treatment options an intermittent SC model~     was developed. The objective of this study was to show the effects of intermittent SC when~     combined with occupational therapy (OT) and BoNT-A injections on spasticity, and passive~     range of motion (pROM) of children with CP having spastic wrist flexion deformity.~   "
19922|NCT03306199|"~     A retrospective study to evaluate Turbo Power laser atherectomy + drug coated balloon (DCB)~     angioplasty for the treatment of femoropopliteal de novo/restenotic lesions and in-stent~     restenosis (ISR).~   "
19923|NCT03306186|"~     A diagnostic devise, namely HemoSpec, had been developed that integrates clinical~     information, along with information on circulating protein biomarkers and the morphology of~     white blood cells to achieve early diagnosis of sepsis. The current study is aiming to~     validate and improve performance of HemoSpec for the rapid assessment of the critically ill~     patient.~   "
19924|NCT03306173|"~     Early attempts by the tobacco industry to develop safer cigarettes led to the widespread~     introduction of ventilation holes in cigarette filters; however, this design feature may~     instead increase smoking-related harm and make cigarettes more palatable. The overall goal of~     this project is to model regulatory restrictions banning cigarette filter ventilation and~     determine their effects on consumption of both cigarettes and a wide range of alternative~     tobacco products. Testing potential regulatory actions under controlled conditions will~     facilitate evidence-based policies that have a net benefit to health.~   "
19925|NCT03306160|"~     This is a prospective cohort study which aims to explore the significance of brachial and~     central ambulatory blood pressure monitoring in predicting cardiovascular risk in patients~     with end stage renal disease who are treated with hemodialysis. Enrolled patients will~     receive a 48-hour central and brachial ambulatory blood pressure monitoring at its first-time~     dialysis after enrollment. And their cardiovascular events and deaths at first and third year~     will be followed-up.~   "
19926|NCT03306147|"~     Chronic pain is one of the most prevalent and debilitating medical conditions and opioid~     analgesics are a commonly prescribed class of medications in the United States. Opioid~     efficacy has been proven in terms of managing acute and chronic pain; however, opioid~     overdose deaths, addictions, and diversions have all continued to increase over the years.~     The purpose of this study is to increase patient engagement in pain management and education,~     and to decrease opioid use by 10% over the study period. This study will also help present~     opportunities for future studies to obtain insight regarding the chronic use of opioids.~   "
19927|NCT03306134|"~     A non-randomised, prospective study to assess the effects of beta-blockers on substance P~     levels and the swallowing function. The study is going to be carry out in the~     Gastrointestinal Physiology Laboratory of the Hospital de Mataró (Spain). All participants~     will be actively recruited from a Linked hospital and primary care database. We include two~     groups: the first group (group 1) are participants taking beta-blockers and the second group~     (group 2) are participants not-taking beta-blockers.~   "
19929|NCT03306108|"~     The study will be conducted as Prospective study including 50 patients (aged <6years ) at~     Otorhinolaryngology department, Assuit University Hospital (aged <6years ) who will undergo~     cochlear implantation. All subjects will undergo implantation with Medel sonata flex 28 or~     standard electrodes with a standard surgical procedure. The standard surgical procedure will~     include extended end aural approach ,posterior tympanotomy and a round window insertion.The~     results of immediate postoperative Neural Response Telemetry (NRT) measurements &~     postoperative CT imaging will be obtained.~      Each patient will be subjected to the following scheme:~        -  immediate postoperative Neural Response Telemetry (NRT) measurements~        -  postoperative CT imaging~        -  Data obtained from both measurements will be used to determine the intra cochlear~          electrode position then both data will be correlated.~   "
19930|NCT03306095|"~     Following endoscopic therapy of variceal bleeding, the issue of when to refeed these patients~     has rarely been investigated. This may imply that feeding is generally regarded as a~     negligible factor in the management of bleeding varices. On the other hand, it is usually~     believed that systematic fasting is required in case of patients with upper gastrointestinal~     bleeding.~      Some researchers in their studies demonstrated that immediate refeeding has similar outcomes~     to delayed refeeding among patients with low risk of nonvariceal bleeding. The situation of~     variceal bleeding is quite different from that of peptic ulcer bleeding as demonstrated by~     studies of other researchers who made a review on feeding of patients with upper~     gastrointestinal bleeding, and recommended that feeding should be delayed for at least 48~     hours after endoscopic therapy because early refeeding may cause a shift in blood flow to the~     splanchnic circulation, which in turn could lead to an increase in pressure and an increased~     risk of rebleeding from the varices.~      The other important reason of delay in feeding may be ascribed to the fear of occurrence of~     early rebleeding induced by refeeding. In addition, repeated endoscopic examination and~     therapy may be required in patients with very early rebleeding. The decision to delay feeding~     is usually based on clinicians 'experience or experts' opinion rather than evidence based.~     That is why we planned this study.~   "
19931|NCT03306082|"~     Cochlear implants are surgically implanted devices which restore the ability to hear to the~     hearing impaired. While remarkably successful, even in the best of performers restoration of~     hearing to levels of normal listeners is unusual. Approximately 3 weeks after surgery,~     cochlear implants are activated via mapping - a process in which each individual electrode~     (FDA approved cochlear implants have between 12 and 22 electrodes) is turned on and the~     stimulus level adjusted to a level that is comfortable and beneficial to the recipient. At~     present, this standard of care mapping procedure is performed without knowledge of the~     physical location between the cochlear implant electrodes and the neural interface. The~     research team has developed a new method of mapping using post-operative CT scans and image~     processing to specify the physical relationship between the cochlear implant electrodes and~     the neural interface allowing customized mapping. Using this information, the investigators~     deactivate sub-optimally positioned electrodes. The investigators term this Image-guided~     Cochlear Implant Programming (IGCIP). The study collects data in a prospective fashion for~     those CI recipient undergoing IGCIP.~   "
19932|NCT03306069|"~     The main purpose of this study is to compare the impact of aerobic interval training~     intensity on exercise adherence and changes in cardiorespiratory fitness, cardiometabolic~     risk profile, body composition, inflammatory markers and subjective health outcomes after a~     12-week intervention trial in overweight individuals at increased cardiometabolic risk.~   "
19933|NCT03306056|"~     The main purpose of this study is to compare the effects of whole-body electromyostimulation~     versus a conventional low-volume strength-training program, each combined with an~     individualized, weight-reducing diet, on the cardiometabolic risk profile, muscle strength,~     body composition, inflammatory markers and subjective health outcomes in overweight~     individuals at increased cardiometabolic risk.~   "
19934|NCT03306043|"~     This is an open-label extension study to Study 200622.In this study subjects from Study~     200622 will be continued on 4-weekly dosing with open-label mepolizumab 300 milligram (mg)~     subcutaneously (SC) for an additional 20 Weeks after completing the 32 Week study assessments~     post-randomization, while they continue with their background HES therapy per standard of~     care (SoC). Subjects from study 200622 will participate in this extension study if they had~     completed the 32-Week treatment period in study 200622 or if they were withdrawn from the~     study pre-maturely, but were continued in the study per protocol until 32 Weeks from~     randomization. Data from this study (205203) and 200622 will be combined to provide up to~     52-Week exposure data to further characterize the long-term safety profile of mepolizumab and~     provide additional data on the clinical benefit in HES subjects beyond 32 Weeks. The duration~     of the study participation will be 20 Weeks for subjects who continue with mepolizumab~     treatment via MHE104317/MHE112562 after this open-label extension study; and 28 Weeks for~     subjects who do not continue with MHE104317/MHE112562.~   "
19935|NCT03306030|"~     Constipation is a common high risk factor for inadequate bowel preparation. The bowel~     cleansing efficacy of the standard split-does of 4L seems to be suboptimal in constipated~     patients. The investigator hypothesized that compared with the standard preparation regime,~     the split-dose with three times of 4L PEG may be superior in BP quality.~   "
19936|NCT03306017|"~     To compare in vivo platelet and leukocyte activation and phenotype before and after Left~     ventricular assist device (LAVD) implantation~   "
19937|NCT03306004|"~     Determine the knowledge attitude and practices of all levels of health care providers about~     neonatal jaundice~   "
19956|NCT03305744|"~     This study evaluates cardiac structure and function differences between healthy endurance~     trained athletes with atrial fibrillation and healthy age matched endurance trained athletes~     without atrial fibrillation. It is hypothesized that despite having similar structural~     adaptations of the heart (due to endurance training), athletes with atrial fibrillation~     display will impaired heart functional measures compared to endurance athletes without atrial~     fibrillation.~   "
20121|NCT03303599|"~     The interferon- and ribavirin- (RBV) free combination regimen of glecaprevir plus~     pibrentasvir (GLE/PIB) for the treatment of genotypes 1 to 6 of chronic hepatitis C (CHC)~     viral infection has been shown to be safe and effective in randomized controlled clinical~     trials.~      This observational study is an effectiveness research examining the regimen of GLE/PIB, used~     according to local label, under real world conditions in a clinical practice patient~     population.~   "
19938|NCT03305991|"~     Women living in low-income countries are at elevated risk of death in connection to~     pregnancy, as well as infants born to women in such settings. It is probable that several~     factors are involved, such as poverty, lack of education and access to healthcare. Infectious~     diseases constitute important threats to maternal health in resource-limited settings.~     Tuberculosis (TB) is reported to be the third leading cause of maternal death globally.~     Furthermore, TB can be transmitted from mother to child during pregnancy, with high risk of~     severe consequences for the infant. Despite these data, neither the role of TB in relation to~     co-existing risk factors for adverse pregnancy outcomes, nor the mechanisms involved, are~     well understood. It is likely that TB interacts with other characteristics, in particular~     socio-economic condition and HIV infection, which could obscure associations between TB and~     pregnancy outcomes. For this reason, it is critical to design studies so that the independent~     role of TB can be deduced.~      This project aims to investigate how TB infection in women affects the risk of adverse~     pregnancy outcomes in relation to co-existing factors, and how exposure to TB infection may~     impact growth and development of infants born to women with TB. In addition, mechanisms in~     which TB and the immune system during pregnancy will be explored.~      The project is conducted at public health facilities in Ethiopia, where 2 000 women will be~     recruited during antenatal care. These women will be followed until 4 years after delivery,~     along with their offspring born during the study period. Detailed data is collected at~     inclusion and at study visits during follow-up, with submission of samples for TB testing and~     immunological analyses.~      Better knowledge on the characteristics of TB infection in association with pregnancy, and~     how TB affects maternal and child health, can be used to construct new guidelines for~     management of TB in women of fertile age. This may contribute to reductions in adverse~     pregnancy outcomes, including maternal and infant deaths.~   "
19939|NCT03305978|"~     Lung cancer screening programs are still discussed in Europe today, and one of the concern is~     radiation due to iterative CT. The aim of this monocentric, prospective, non randomized study~     is to compare an ultra low dose chest CT (approaching a two views X ray) versus a standard~     low dose chest CT for ≥4mm lung nodules detection, and secondary for lung nodule~     characterization and smoking associated findings (emphysema, bronchial abnormalities and~     coronary calcifications).~   "
19940|NCT03305965|"~     Rationale: Supportive care such as physical therapy, psycho-social education, and dietary~     advice is likely to have a positive effect on the recovery and quality of life of cancer~     patients. Currently, not all patients know how to access supportive care, which results in~     unmet supportive care needs. This study determines whether these unmet needs can be reduced~     or prevented by a patient navigation intervention that focuses on timely screening and~     systematic monitoring of patient's supportive care needs.~      Objective: The primary objective is to determine the effect of patient navigation on health~     related quality of life. Secondary objectives are: 1) to determine the effect of patient~     navigation on satisfaction with, need for, and consumption of (supportive) cancer care; 2) to~     determine the effect of patient navigation on patients' self-management; 3) to explore how~     patient navigation affects the cost-effectiveness of cancer care.~      Study design: Longitudinal randomised controlled trial with two study arms: a patient~     navigation intervention and care as usual.~      Study population: Newly diagnosed lung, melanoma, urology, or gynecology patients of the~     Netherlands Cancer Institute.~      Intervention : Consultations with a specifically trained oncology nurse (i.e. patient~     navigator), who assesses patients' needs for supportive cancer care, provides information on~     supportive cancer care, and guides patients through the supportive cancer care system.~     Consultations with the patient navigator take place at the start, halfway through, and at the~     end of treatment.~      Main study endpoints: The main endpoint of this study is health related quality of life,~     which is defined as an individual's perceived emotional, social, physical, and functional~     wellbeing over time. Health related quality of life is assessed with the EORTC QLQ-C30.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: Participants are expected to strongly benefit from consulting the patient~     navigator without being subjected to any severe risks. Consultations will be provided by~     highly qualified professionals, and result in benefits such as decreased severity of~     cancer-related psychosocial and physical distress. To minimise burden, face-to-face~     consultations will always be scheduled alongside other appointments of at the NKI-AVL.~     Furthermore, questionnaire completion takes no more than 30 minutes per data collection~     round, of which three are scheduled in this study.~   "
19941|NCT03305952|"~     There is a growing number of evidence of how mindfulness training enhances psychological and~     physical well-being and coping strategies in patients with oncological illnesses. However,~     there are very few studies analyzing the efficacy of Compassion-Based Interventions on breast~     cancer survivors.~      The goal of this study is to analyze enrollment, participant satisfaction and adherence to~     program and differences in psychological well-being, health related quality of life, fear of~     illness recurrence, compassion and self-compassion variables after a Compassion-Based~     Intervention in a Spanish breast cancer survivor sample.~      This study is a randomized clinical trial of a secularized intervention called~     Cognitively-Based Compassion Training (CBCT). Subjects (n = 58) were randomly assigned to~     CBCT (n = 28) or a treatment as usual control group (TAU) (n = 28). Participants in the CBCT~     intervention condition were asked to meet weekly for a two (2) hour long session during two~     months. Pre-post-intervention and six month follow-up measures took place to evaluate:~     psychological well-being (somatic, depressive, and anxious symptomatology), health related~     quality of life (physical, social, emotional, and functional); psychological stress, coping~     strategies and triggering cognitions linked to cancer recurrence fear, self-compassion,~     compassion and mindfulness and awareness in both intervention and wait list groups.~      CBCT is a promising and potentially useful intervention to enhance physical and emotional~     well-being in breast cancer survivors. Nevertheless, future randomized trials are needed and~     a process of cultural adaptation required.~   "
19942|NCT03305939|"~     Diabetes mellitus is a major public health concern for both the developed and the developing~     countries. Globally 246 million people affected with diabetes, and will rise up to 300~     million by 2025. In India, around 25% of the 25 million pregnancies are associated with~     gestational diabetes mellitus (GDM), and increasing rapidly over the time. Reported~     prevalence rates for GDM for Sri Lanka (13%) and Bangladesh (10%) have been described.~     However, in Bangladesh, estimate varies from 9.7% to 12.9% when different criteria were used.~      Knowledge gap: There is knowledge gap on whether a resource- and culturally-appropriate~     lifestyle intervention program will be more effective and cost effective relative to usual~     care in delaying incidence of T2D among women in South Asia. Evidence of developed countries~     indicate that a low-intensity lifestyle intervention, integrated with antenatal care in~     health system, optimizes healthy diet and attenuates physical activity decline in early~     pregnancy.~      Objective of the study: 1.To determine whether a resource- and culturally-appropriate~     lifestyle intervention program in Bangladesh , provided to women with prior gestational~     diabetes after delivery, will reduce the incidence of worsening of glycaemic status.~      2. To explore whether the designated lifestyle intervention program is affordable, acceptable~     and scalable locally.~      Methods:~      Study design: An open-label parallel group pragmatic individual randomized controlled trial~     with blinded primary endpoint adjudication. The randomized controlled trial will be preceded~     by an intervention development and optimization phase.~      Intervention: Low intensity lifestyle modification program Duration of intervention delivery:~     1 years (12 months) and respondents would be followed up 6 monthly for next 3 years (36~     months).Study settings: In Bangladesh, the investigators will conduct the intervention trial~     in 4 maternity care hospitals in Dhaka city.~      Sample size: A total of 1440 women with GDM from 24 hospitals (~60/hospital) will require for~     the RCT from 3 different countries. In Bangladesh, 360 participants from 4 selected maternity~     care hospitals (90 participants from each hospital, 45 cases and 45 controls) will be~     required.~      Inclusion Criteria: Absence of T2DM at 6±3months post-partum OGTT.~      Anticipated outcomes: Primary outcomes:~      Proportion of women with a change of glycaemic category, at or prior to final visit:~      Normal glucose tolerance to impaired fasting glucose (IFG) or impaired glucose tolerance~     (IGT) or T2DM; and/or impaired fasting glucose/impaired glucose tolerance to type 2 Diabetes~     Mellitus (DM)~      Secondary outcomes:~      Mean changes in Body weight, Mean changes in waist circumference, Mean changes in systolic~     blood pressure, mean changes in fasting blood glucose, mean changes in physical activity, and~     mean changes in fruits and vegetable consumption (changes in dietary pattern), incremental~     cost effectiveness ratio.~   "
20222|NCT03302273|"~     To study of a novel, therapeutic Human Cells, Tissues, and Cellular and Tissue-Based Product~     (HCT/P) in the treatment of severe dry eye disease that is failing conventional treatments.~     This pilot study will carefully observe and monitor each qualifying and willing individual~     for response to treatment, signs of toxicity and adverse effects from the treatment, and for~     ability of the treatment to improve comfort and restore vision.~   "
19943|NCT03305926|"~     Cardiovascular rehabilitation (CVR) has major beneficial effects by improving physical~     capacity, accelerating return to activities and reinsertion and reducing mortality. It~     associates reconditioning to effort and therapeutic education for the optimal control of ~     risk factors . It corresponds to a global approach to patients, thus counterbalancing the~     tendency to hyperspecialise in medicine. However, because of the lack of specialised centres,~     only a small proportion of patients (≈30%) are able to benefit. Numerical tools used in~     e-health, the deployment of the Internet and certain  connected  devices may provide~     alternatives outside hospital, by enabling the follow-up of patients and their physiological~     parameters (heart rate, blood pressure, weigh, physical activity…), and the adaptation -~     using an interactive web platform - of the physical activity programme, nutrition, compliance~     with medication and weaning from smoking. This project proposes to evaluate the effects of a~     so-called  connected  CVR programme, and to show its non-inferiority compared with a~     conventional CVR.~   "
19944|NCT03305913|"~     0116-ASG REMETY is a multicenter, open-label, non-randomized, dose-escalation Phase I study~     evaluating the safety and anti-tumor activity of TAS-102 administered in combination with~     Regorafenib in patients with metastatic colorectal cancer.~   "
19945|NCT03305900|"~     Formate is an important metabolite, serving as a donor of one-carbon groups to the~     intracellular tetrahydrofolate pool. However, little is known of its circulating~     concentrations or of their determinants. This study seeks to define formate levels and their~     determinants in a young, healthy population.~      Serum formate will be measured in 1701 subjects from the Trinity Student Study. The subjects,~     males and females, aged 18 to 28 years, were enrolled at Trinity College, Dublin. Formate~     levels will be compared with other one-carbon metabolites, vitamin status, potential formate~     precursors, genetic polymorphisms, and lifestyle factors.~   "
19946|NCT03305887|"~     A post-marketing prospective, multicenter, randomized controlled study to evaluate the wound~     closure efficiency of STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device~     (STRATAFIX Symmetric PDS Plus) compared to conventional sutures in total knee arthoplasty~     (TKA)~   "
19947|NCT03305874|"~     Contrast agent is typically used during routine cardiac intervention in order to enhance the~     imaging necessary to perform the procedure. Using this contrast agent could lead to kidney~     injury, called contrast induced nephropathy (CIN). Currently, the methods used to reduce the~     risk of CIN include reducing the amount of contrast agent used and using a hydration strategy~     during procedure. A computer-based risk tool has been developed which reports a risk score~     for the likelihood a person undergoing cardiac intervention gets CIN and a proposed~     corresponding hydration strategy to reduce the risk of CIN. The purpose of this study is to~     determine whether the rate of CIN decreases when the treating physician has access to this~     risk tool during the procedure.~   "
19948|NCT03305861|"~     In this study the investigators aim to test Thulium Laser 200 W Enucleation of the Prostate~     (ThuLEP) vs Greenlight (532-nm) laser Photoselective Enucleation of the Prostate (Green LEP)~     using (XPS) 180W system vs the gold standard Holmium laser Enucleation of Prostate (HoLEP) in~     reduction of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia~     (BPH) in a randomized controlled trial. Furthermore, all peri-operative parameters, urinary~     flow parameters, prostate size changes and complications associated with the procedures will~     be compared.~   "
19949|NCT03305848|"~     This study is designed to obtain data on the safety and efficacy of oral nitroglycerin~     solution for the treatment of esophageal food impaction in patients presenting to the~     Emergency Department with presumed esophageal food impaction. The main hypothesis is to~     determine the success rate of oral nitroglycerin solution in relieving the food impaction by~     assessing the resolution of symptoms and the ability of the patient to swallow.~   "
19950|NCT03305835|"~     90 genes related to Monogenic Stone Disease will be determined via DNA analysis by the Mayo~     Rare Kidney Stone Consortium (RKSC) research staff.~   "
19951|NCT03305822|"~     The purpose of this study is to compare LY900014 with insulin lispro (Humalog) in~     participants with type 2 diabetes mellitus. The study will be conducted in participants with~     type 2 diabetes on insulin injection therapy to investigate how the body processes LY900014~     and the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog).~      Screening is required within 28 days prior to the start of the study. For each participant,~     the total duration of the clinical trial will be between 3 and 8 weeks.~   "
19952|NCT03305809|"~     A randomized placebo-controlled trial in individuals with Parkinson's disease dementia to~     evaluate the safety and efficacy of three doses of study drug LY3154207 in participants with~     mild-to-moderate Parkinson's disease dementia treated for 12 weeks.~   "
19953|NCT03305796|"~     Cholesteatoma is a retraction pocket lined with squamous epithelium lined with keratin debris~     occurring within pneumatized spaces of the temporal bone. Cholesteatomas have a propensity~     for growth, bone destruction, and chronic infection.High-resolution computerized tomography~     is the method of choice for imaging the middle ear .~   "
19954|NCT03305783|"~     The effect of cholecystectomy on postprandial plasma GLP-1 responses (primary endpoint) and~     glucose metabolism will be evaluated in 30 patients planned to undergo elective laparoscopic~     cholecystectomy.~   "
19955|NCT03305757|"~     Rationale: Seroma formation and its sequelae form the mainstay of complications in breast~     cancer surgery. Seroma has an incidence of 3% to 85%. Complications vary from delayed wound~     healing, infection, skin flap necrosis, patient discomfort and repeated visits to the out~     patient clinic. The key to reducing seroma formations seems to partly lie in the obliteration~     of dead space. The use of electrocautery has been demonstrated to increase seroma formation~     following mastectomy, however no other surgical devices (laser scalpel, argon diathermy and~     ultrasonic scalpel) or substances have proven to be superior in seroma reduction.~      No prospective randomized controlled trials have been able to demonstrate which techniques~     are superior in reducing seroma and as a consequence patient discomfort in patients~     undergoing mastectomy. In a previous retrospective observational study these investigators~     demonstrated that mastectomy flap fixation significantly reduced seroma formation and the~     number of seroma aspirations. In a pilot study that was recently performed in one of the~     investigators hospitals, ARTISS tissue glue was used for skin flap fixation and showed~     promising results. The investigators hypothesize that obliteration of the dead space~     following mastectomy will significantly reduce seroma formation, its complications and the~     discomfort it causes patients undergoing mastectomy.~   "
19957|NCT03305731|"~     Stroke survivors demonstrate high levels of sedentary behavior, placing them at risk for~     exacerbation of chronic health conditions. This may lead to recurrent stroke. Subtle~     cognitive impairments are common after stroke and can lead to difficulty self-monitoring and~     problem solving to overcome barriers to physical activity. Investigators developed the~     Activating Behavior for Lasting Engagement (ABLE) intervention to promote activity~     scheduling, self-monitoring, and problem solving activity over the full day. This study~     examines the effects of the ABLE intervention on sedentary behavior after stroke.~   "
19958|NCT03305718|"~     The discovery of biomarkers for the intake of meats and potatoes is needed for an accurate~     assessment of the intake of these foods. Twelve healthy subjects were enrolled in a~     controlled, cross-over meal study, randomized by a Latin square design. The test meals~     contained 1) beef, pork, chicken and a control meal for the meats and 2) french fries, boiled~     potatoes, chips and a control for the potato meals. A standardized diet was provided during~     sample collection. Blood and urine samples were collected up to 48h primarily for untargeted~     metabolomic profiling. Blood was further collected to study the effect of the meals on~     insulin and glycemic responses. Effects on satiety were measured by VAS and an ad libitum~     lunch following the test meals.~   "
19959|NCT03305705|"~     This study investigates the effect of intravenous iron substitution in non-anaemic~     premenopausal women with iron deficiency on:~        -  Changes in the cerebral Dopamine (DA) receptor density after iron substitution, shown by~          brain PET~        -  Reduction of fatigue and other neuropsychological symptoms after iron supplementation~   "
19960|NCT03305692|"~     Cardiac resynchronization therapy (CRT) has been a valuable intervention for patients with~     systolic heart failure for over 15 years. Despite years of research, there is a still a~     25-40% non-responder rate depending on the outcomes measured. CRT optimization is a term used~     to describe the act of individualizing the therapy (CRT programming) for an individual~     patient. This is not often performed, but when it is, echocardiography is utilized. Recent~     work of body surface mapping using a novel system called the ECG Belt has shown a~     relationship between measures of electrical dyssynchrony and acute and chronic heart pumping~     function. This study will compare outcomes of patients randomized to either echocardiographic~     or ECG Belt optimization of CRT devices.~   "
19961|NCT03305679|"~     Aim: The aim of this study to Assess the healing process of the immediate implant loading~     with two different provisional techniques (direct and indirect).~      Materials and methods:~      20 implant in the aesthetic zone either in the incisor or in the canine area and excluding~     the lateral location and then immediate loading is achieved for the 20 implants (10 for~     direct and 10 for indirect method) Clinical Aspect :color change , healing and bone~     resorption Esthetic assessment and patient acceptance will be assessed using specific tools.~      Lab aspect: surface roughness and Marginal fit will be measured to have clue vision.~   "
19962|NCT03305666|"~     Rib fractures represent a common injury pattern this is highly associated with patient~     morbidity and mortality, as pain control remains a challenge. Even after surgical~     stabilization of rib fractures (SSRF), unsuccessful pain control can lead to morbid outcomes~     such as pneumonia and opioid dependence. Multi-modal anesthesia, with the use of thoracic~     epidurals and para-vertebral injections/catheters, has shown to lessen these occurrences but~     are subject to a wide array of limitations. A more directed therapy with liposomal~     bupivacaine has shown to provide sustained analgesia for up to 72 hours in patients who have~     undergone other types of thoracic surgery, but not SSRF. The hypothesis of the current~     clinical trial is that, among patients undergoing SSRF, liposomal bupivacaine delivered via~     video assisted thoracic surgery (VATS) is an intercostal nerve block that provides comparable~     analgesia to the pain catheter, as measured by pulmonary function, numeric pain scoring, and~     postoperative narcotic use.~   "
19963|NCT03305653|"~     Presently, the only method available to monitor disease activity in Eosinophilic Esophagitis~     (EoE) is endoscopy with pathological review of biopsies. The overall goal of this study is to~     determine the ability of the Esophageal String Test (EST), a minimally invasive capsule based~     technology, to measure disease activity in children with EoE. Additionally, to determine~     esophageal distensibility in children presenting with EoE by using the EndoFLIP (functional~     luminal imaging probe) device during endoscopic procedures.~   "
19964|NCT03305640|"~     Treatment of acetabular fractures needs a perfect diagnosis to anticipate surgical~     difficulties. E. Letournel described a rare atypical both-column fracture which  introduces~     enormous surgical difficulties . Its particularity is a sagittal comminution interesting the~     acetabular roof.~      In this experience the particular fracture is probably under-diagnosed. The purpose of this~     study is to give the exact incidence and a precise description of these fractures to improve~     their surgical management.~   "
19965|NCT03305627|"~     Cystectomy with urinary diversion (ileal conduit, orthotopic ileal bladder substitute,~     continent catheterizable pouch) is the best treatment option for patients with~     muscle-invasive bladder cancer. This intervention is one of the most challenging in urology~     and has a high rate of postoperative complications including around 30% of postoperative~     infections.~      Perioperative antibiotic prophylaxis (PAP) is widely accepted as a crucial preventive measure~     to reduce the incidence of surgical site infections (SSI). The rationale for PAP is the~     reduction of the local bacterial load at the site and time of intervention, and therefore a~     short duration of PAP of 24 to maximal 48 hours is recommended for all clean to~     clean-contaminated procedures..~      Evidence supporting the optimal duration of PAP for radical cystectomy with urinary diversion~     is lacking. Based on data extrapolated from abdominal surgery, current guidelines recommend~     short-term PAP (≤24h) for all clean-contaminated procedures including radical cystectomy.~      However, a recent evaluation revealed a significant inter-hospital variability of PAP and~     showed that extended use (>48h) was common in patients undergoing radical cystectomy.~     Importantly, this study also demonstrated that longer duration of PAP incurred higher costs~     and was associated with an increased rate of C. difficile colitis. A small, prospective,~     non-randomized study showed equal efficacy of short-term PAP in preventing postoperative~     infections in patients undergoing radical cystectomy with ileum conduit compared to extended~     PAP. Nonetheless, larger randomized clinical trials supporting these findings are lacking.~      The unwarranted extended use of antibiotics is a major concern as exposure to antibiotics is~     a driving force for the development of (multi-) resistant bacteria and will lead to an~     increasing number of difficult-to-treat infections. This has been recognized on both national~     and international levels and is addressed within antimicrobial stewardship frameworks.~      This study will compare current practice (>48h PAP, extended PAP) with the guideline~     recommended approach (24h PAP, short term PAP) in a single-centre, prospective, randomised~     clinical non-inferiority trial. The primary outcome is the rate of SSI within 90 days post~     surgery. The aim of the study is to generate currently lacking evidence allowing for an~     optimised PAP strategy in a challenging surgical setting.~   "
19966|NCT03305614|"~     This study evaluates the neuromodulatory effect of combined tDCS and aphasia therapy in~     patients in the chronic phase after stroke. Half of the participants will receive aphasia~     therapy and tDCS, the other half will receive aphasia therapy and sham-tDCS.~   "
19967|NCT03305601|"~     During the pregnancy , it's now compulsary for the doctors to inform pregnant women and the~     couple about the medical, non medical informations and explain the physiological changes . As~     usual, medical staff and doctors explain and inform by oral and with a booklet patient.~      In order to cluster and make more accessible these informations, the maternity team of GHPSJ~     has developed an application on smartphone . If this application has been evaluated on his~     contents and accordance to recommendations, there is no evaluation about the satisfaction of~     patient.~      The aim is to study the impact of this kind of application on pregnant women satisfaction.~   "
19968|NCT03305588|"~     To determine the efficacy of frameless Virtual Cone Radiosurgical Thalamotomy for medically~     refractory tremor resulting from either Essential Tremor or Tremor-Dominant Parkinson's~     Disease with the Fahn-Tolosa-Marin Tremor Rating Scale (FTMTRS) in patients who are not~     candidates for deep brain stimulation (DBS).~   "
19969|NCT03305575|"~     This study aims to compare the effect of chloroprocaine vs. bupivacaine on duration of motor~     block and duration until meeting discharge criteria in patients undergoing cervical cerclage.~     The hypothesis is that chloroprocaine will result in faster resolution of motor block.~   "
19970|NCT03305562|"~     Pediatric hypertension is increasingly common and is a precursor for adult cardiovascular and~     renal disease. But even during childhood, hypertension is associated with significant~     morbidity, including cognitive impairment and organ damage. However, the cause of pediatric~     hypertension, the response to treatment, and the mechanisms behind organ damage are~     incompletely understood. Due to these limitations, there are no first-line medications, and~     treatment is often inadequate. An improved comprehension of the course of pediatric~     hypertension could enhance clinical care. The goal of this proposal is to create a registry~     of patients with hypertension to better enable research into this important disease. This~     patient registry will enhance the investigators ability to quickly collect and analyze data~     for research studies.~   "
19971|NCT03305549|"~     The Recovery After Dialysis-Requiring Acute Kidney Injury (RAD-AKI) Pilot Study is a 2-arm~     randomized clinical trial of hospitalized patients with dialysis-requiring acute kidney~     injury (RAD-AKI), comparing conventional thrice-weekly intermittent hemodialysis dialysis~     (control) to a conservative dialysis strategy in which hemodialysis is not continued unless~     specific metabolic or clinical indications for RRT are present. The overall hypothesis is~     that the current practice of thrice-weekly acute intermittent hemodialysis for AKI-D masks~     evidence of renal recovery and may actually delay or preclude recovery. The primary objective~     of this pilot study is to assess the safety and feasibility of the proposed intervention and~     study design.~   "
19972|NCT03305536|"~     Aortic Stenosis is a common but fatal disease when it becomes symptomatic, specially if not~     treated. Until now surgery remains the only reliable and effective treatment.~      In this study, the investigators will examine the effect of high dose of Menaquinone-7 (MK-7)~     supplementation (1000 mcg)/day on the progression of the aortic valve disease. The~     investigators hypothesize that MK-7 supplementation may slow or even reverse the progression~     of the disease process.~   "
19973|NCT03305523|"~     Since circumcision is a significant workload for surgeons working at the rural state~     hospitals in Turkey, the use of circumcision techniques that are easy to implement and have~     low complications is becoming widespread. This research will examine short and long-term~     complications of male circumcisions using thermocautery technique in light of current~     literature.~   "
19974|NCT03305510|"~     Between March 2016 and March 2017, we performed a large retrospective, non-interventional,~     single-center cohort study and measured 25(OH)D3 plasma levels prior to ovarian stimulation~     in couples who underwent IVF/ICSI.And we analysed the correlation of vitamin D status and~     reproductive capacity .~   "
19975|NCT03305497|"~     The escalating opioid overdose epidemic is one of the most serious public health problems~     confronting the U.S. Death due to drug overdose is a significant and rising cause of~     mortality and morbidity in Philadelphia. While naloxone is increasingly accessible to combat~     opioid overdoses, new responses to delivering naloxone to overdose events are needed. The~     proposed pilot project, to be conducted in Philadelphia, will pursue three specific aims: 1)~     Identify barriers and facilitators of acceptance and use of a smartphone-based naloxone~     intervention; 2) Pilot test the implementation of the intervention among 55 non-medical~     opioid users and 55 community members; 3) Synthesize knowledge acquired in Aims 1 and 2 to be~     used in a subsequent R01 study to conduct a large-scale, multi-site implementation trial.~   "
19976|NCT03305484|"~     Specific Aims~        1. Develop risk assessment scores for SCL wearers~        2. Test the scoring algorithm in SCL wearers who present with adverse events~        3. Explore targeted patient education to reduce risk behaviors associated with SCL wear.~   "
19977|NCT03305471|"~     This three-part study will be performed with participants on chronic hemodialysis.~        -  Part A will assess plasma pharmacokinetics of DS2330a (free form of DS2330b) after a~          single dose of powder in bottle (PIB) or tablet formulations of DS2330b~        -  Part B will test the safety, tolerability, and effects on serum phosphate (Pi) of 14-day~          repeated oral doses of DS-2330b PIB when given alone and when given along with sevelamer~          carbonate three times a day~        -  Part C is optional, and will test the effects on serum phosphate (Pi) of 14-day repeated~          oral doses of DS-2330b tablets when given with sevelamer carbonate~      After screening, participants should expect the study to last about 21 days for Part A, and~     46 days for Parts B and C.~   "
19986|NCT03305354|"~     Veterans of the most recent wars in Afghanistan and Iraq (collectively, post 9/11 Veterans)~     have notable sleep problems including chronic insomnia. Here, the investigators plan to~     compare two groups of veterans with insomnia: (1) one group that completes a 6 week~     self-management-guided use of a mobile app based on cognitive behavioral therapy for insomnia~     (CBTI alone) and (2) one group that completes a 6 week combined self-management-guided use of~     the mobile CBTI app in addition to a physical activity (PA) intervention (CBTI + PA). The~     investigators hypothesize that the group receiving the adjunctive 6-week PA intervention will~     have better subjective and objective sleep, higher step counts, and better functional health~     and social and community integration than those receiving CBTI alone. This pilot work will~     provide evidence to guide the design of a future randomized controlled trial.~   "
26904|NCT03214822|"~     This is a randomized controlled trial of a human-derived human milk fortifier (H2MF) vs~     standard bovine-derived human milk fortifier (HMF) evaluating fecal microbiota and fecal and~     urinary biomarkers of oxidative stress in premature infants.~   "
19978|NCT03305458|"~     The investigators recently completed an NIMH R34 in which they piloted a patient- and~     provider-informed tablet-based toolkit designed to facilitate delivery of Trauma-Focused~     Cognitive Behavioral Therapy (TF-CBT) - a treatment that was selected because it addresses a~     wide range of symptoms using techniques shared by other treatments for emotional and~     behavioral disorders. The tablet-based toolkit consists of numerous components (e.g., videos,~     interactive games, drawing applications) that are designed to facilitate provider-patient~     interactions in a way that enhances children's engagement and supports adherence to the~     treatment model. The tablet-based toolkit was very well received by children, caregivers, and~     providers in the pilot evaluation. Moreover, all benchmarks for feasibility were met or~     exceeded. This study proposes to conduct a hybrid effectiveness-implementation trial to~     examine the extent to which the tablet intervention may improve fidelity, engagement, and~     children's mental health outcomes. The investigators will conduct a randomized controlled~     trial with 120 mental health providers and 360 families in partnership with dozens of clinics~     in the Carolinas and Florida. Providers will be assigned randomly to tablet-facilitated vs.~     standard TF-CBT. Youth aged 8-16 years with clinically elevated symptoms of PTSD will be~     recruited. Baseline and 3-, 6-, 9-, and 12-month post-baseline assessments will be conducted~     by independent, blind evaluators. Sessions will be videorecorded for observational coding of~     engagement and fidelity by independent raters blind to study hypotheses. The investigators~     will also examine costs and conduct semi-structured interviews with families, providers,~     supervisors, and agency leaders to inform future dissemination and implementation~     initiatives. Technology-based resources that are scalable, easy to use, and designed for~     efficient integration into everyday practice may have sustained national impact.~   "
19979|NCT03305445|"~     This multi-center study open-label trial will enroll a single cohort of relapsed/refractory~     diffuse large B cell lymphoma (DLBCL) patients whom are ineligible for autologous stem cell~     transplant (ASCT) due to 1) insensitivity to salvage chemotherapy, or 2) inability to~     tolerate high-dose myeloablative chemotherapy. All patients will receive dual checkpoint~     blocking antibody (DCBA) therapy with established doses currently being used in phase III~     trials of ipilimumab (1mg/kg) and nivolumab (3mg/kg) given at three week intervals, two times~     before, and two times following immunotransplant in which T cells (in whole PBMCs) are~     cryopreserved and re-infused (adoptive T cell transfer or ATCT) following lymphodepleting~     chemotherapy regimen, currently being employed in adoptive T cell therapies.~   "
19980|NCT03305432|"~     he purpose of this study is to study the effect of preoperative PPI in the early outcome of~     sleeve gastrectomy~   "
19981|NCT03305419|"~     This study is designed to evaluate the safety, tolerability and PK of GSK2982772, in repeat~     oral doses in healthy subjects. This study is being conducted to support administration of~     higher dose levels of GSK2982772 than initially studied in the First Time in Human (FTiH)~     study. This study will also assess the impact of food during the repeat doses of GSK2982772.~     This will be a two part study; Part A and Part B. Part A (cohort 1) - single ascending dose,~     randomized, placebo-controlled, 3-way crossover. Part B (cohorts 2, 3 and 4) - repeat dose,~     randomized, placebo-controlled, sequential-group. Subjects will be randomized in 3:1 ratio to~     receive GSK2982772 or placebo in crossover manner on Day 1 of each of the three periods in~     Part A and in sequential groups for 14 days in Part B. Approximately 48 subjects will be~     included in this study. The study duration, including screening and follow-up, will not be~     expected to exceed 13 weeks for Part A and 8 weeks for Part B.~   "
19982|NCT03305406|"~     In Toronto Ontario, the Parkdale Community Health Centre operates a community outreach~     program entitled Parkdale Parents' Primary Prevention Project (5P's). The 5P's provides~     weekly pre- and post-natal support and education programs for clients. This includes an~     infant feeding program for mothers with infants 0-6 months (Feeding Tiny Souls). The 5P's has~     a diverse client-base; the program is aimed at women who are in challenging life~     circumstances, therefore, clients may include low-income or single mothers and newcomers to~     Canada.~      The overall goal of this research is to optimize the existing 5P's program. Program~     acceptability is an essential component of the process evaluation to understand the~     experiences of mothers and the perceived supports and barriers of the program. Specifically,~     the aim of this project is twofold: 1) to investigate the perceptions and experiences of~     accessibility of a postnatal community program and 2) to explore the perceptions of, and~     attitudes toward, a community infant feeding program offering lactation consultant and breast~     pump resources. This study will use a qualitative approach by way of semi-structured focus~     groups and interviews. The study population will consist of women who enrolled in 5P's~     prenatally and have delivered their infant. This will include women who did and did not~     continue to participate in the postnatal program and/or Feeding Tiny Souls after delivery.~     The investigators will specifically seek women who participated in the prenatal program, but~     did not take part in the postnatal program and/or Feeding Tiny Souls to understand why~     participants did not access these resources and gather information on their views of these~     postnatal program components. The hypothesis is that the postnatal community program is a~     source of support for clients, but that it needs to be expanded to include more clients and~     the infant feeding program is an important support for helping clients to provide breast milk~     to their infant.~   "
19983|NCT03305393|"~     IMPROVE RESPONSE is a physician initiated research study. It is a prospective,~     non-randomized, multi-center, post-market, U.S. Cardiac Resynchronization Therapy (CRT) in~     heart failure (HF) observational study. The purpose of this clinical study is to test the~     hypothesis that market-released CRT devices, which contain the AdaptivCRT (aCRT) algorithm~     have an incremental benefit in improving CRT response in a chronic CRT non responder~     population with left bundle branch block (LBBB) and normal atrio-ventricular (AV) condition~     compared to CRT devices with traditional biventricular pacing delivery methods at generator~     replacement.~   "
19984|NCT03305380|"~     The investigators will develop a radiomics signature for immune checkpoint-induced~     pneumonitis in 40 patients with a pulmonary event under anti-PD1 or anti-PD-L1 (cases) and 40~     patients without a pulmonary event under anti-PD1 or anti-PD-L1 (controls).~      On the basis of the case-control study of patients treated with anti-PD1 or anti-PD-L1, they~     will further optimise the model using reinforcement machine learning. The model will then be~     validated in 300 prospective patients.~   "
19985|NCT03305367|"~     Several free fatty acids receptors (FFARs) have been discovered. These have been implicated~     in metabolic processes and inflammation. Consequently, these receptors have attracted~     interest as targets for the treatment of metabolic and inflammatory diseases, including~     obesity and T2D. Two of these FFARs (FFAR1, FFAR4), which is activated by specific free fatty~     acids (FFAs), is expressed on enteroendocrine cells, pancreatic beta-cells and adipocytes.~     They have been linked to 1) increased GLP-1 secretion and hence the incretin-mediated~     increase in glucose-stimulated insulin secretion (GSIS) and suppression of glucagon~     secretion, 2) a direct positive effect on GSIS, 3) reduced inflammation and 4) improved~     insulin sensitivity. These functions and the abundance of fatty acids in food suggests that~     FFARs can be considered as nutrient sensing regulators of metabolism. Roux-en-Y gastric~     bypass (RYGB), frequently results in immediate beneficial effects on glucose metabolism and~     often complete remission of T2D. This may in part be explained by increased GLP-1 levels~     after surgery. It appears that the effect depends on nutrient delivery directly to the lower~     parts of the small intestine. It is possible that the RYGB effects are partly due to~     enteroendocrine stimulation of FFAR1 and perhaps FFAR4 by direct nutrient delivery, i.e. FFA~     release in the lower intestines. Pinolenic acid from pine nuts has been shown to be a potent~     dual FFAR1/FFAR4 agonist.~      Based on these findings we have planned a number of human intervention studies in order to~     investigate 1) the optimal oral formulation of pine nut oil 2) whether we can mimic the~     beneficial effects observed after RYGB, 2) if we can increase meal-related GLP-1 secretion by~     stimulating FFAR1/FFAR4 on enteroendocrine cells causing improved GSIS and increased satiety~     and 3) enhancement of GSIS by directly stimulating FFAR1 (and perhaps FFAR4) on beta-cells.~   "
20424|NCT03299634|"~     This cross-sectional study will assess the prevalence of oral changes among smokers in an~     Egyptian cohort (patients attending to the hospital of Faculty of Dentistry - Cairo~     University), aiming that this study can serve as a baseline for future studies with the goal~     of finding ways to improve oral health and increase awareness of the hazards of smoking in~     Egypt~   "
19987|NCT03305341|"~     -  Correlate Topoisomerase II Gene Single Nucleotide Polymorphisms (SNPs) to Using~          Etoposide Therapeutic Effects of Treating Small Cell Lung Cancer (SCLC)~        -  Correlate CYP450 3A4 Gene Single Nucleotide Polymorphisms (SNPs) to Using Etoposide Side~          Effects of Treating Small Cell Lung Cancer (SCLC)~        -  Correlate Dihydrofolic-Acid Reductase Gene Single Nucleotide Polymorphisms (SNPs) to~          Using Methotrexate Therapeutic Effects of Treating Small Cell Lung Cancer (SCLC)~        -  Correlate Dihydrofolate Reductase Gene Single Nucleotide Polymorphisms (SNPs) to Using~          Methotrexate Side Effects of Treating Small Cell Lung Cancer (SCLC)~        -  Correlate Thymidylate Synthetase Gene Single Nucleotide Polymorphisms (SNPs) to Using~          Methotrexate Side Effects of Treating Small Cell Lung Cancer (SCLC)~   "
19988|NCT03305328|"~     The present study seeks to evaluate the clinical utility of repeated transcranial alternating~     current stimulation (tACS) by assessing long-term, lasting changes in oscillatory activity~     and subsequent changes in related behavioral processes of anxious arousal and sensory~     sensitivity. To date, only transient effects of tACS have been reported, lasting no longer~     than 30 to 70 minutes. In order to be truly impactful within a clinical setting, however,~     evidence for long-term effects of tACS is needed.~   "
19989|NCT03305315|"~     Given the frequency of temporomandibular joint (TMJ) dysfunction and the variations in its~     expression, this project intends to initiate a process of objective evaluation of mandible~     function and its impairment due to different diseases. The first step is to determine whether~     3D kinematic quantification of the mandible would make it possible to objectively assess the~     effect of post-operative management on TMJ function recovery. If the first results are~     encouraging and show the sensitivity of the analysis of minor joint dysfunctions, the~     investigators will evaluate the feasibility of kinematic assessments for major TMJ~     dysfunctions and for the follow-up of patients.~      The expected benefits of this study are to be considered in the medium term and concern the~     possibilities offered by measuring mandible kinetics in the treatment of TMJ disorders.~   "
19990|NCT03305302|"~     In terms of incidence, cancer of the tongue is one of the leading cancers in France.~     Moreover, this cancer is associated with physiological complications ranging from swallowing~     disorders to loss of taste. Following surgery, impaired perception of food taste may lead to~     cachexia. It is therefore necessary to carry out research in the field of impaired taste,~     notably with regard to the regeneration of taste buds. However, there is currently no~     available functional model of taste bud cells.~      It is therefore necessary to obtain a cell line of human taste cells. These immortalised~     human cells will allow us to better orient our investigations for applications in humans:~     search for and characterisation of taste modifiers synthesised using organic chemistry,~     able to trigger the perception of food in cases of taste loss or taste impairment.~      Moreover, given recent studies conducted by the investigating team proposing the existence of~     a fatty taste and its implication in obesity, the work of the team could be oriented towards~     the synthesis of lipid-receptor agonists, by analogy with artificial sweeteners instead of~     sugar. The availability of these chemical molecules would lead to a reduction in lipid intake~     as these agents contain no (or very few) calories. They will act as an organoleptic decoy.~   "
19991|NCT03305289|"~     To investigate the brain activations related to TN, using fMRI, and to evaluate changes in~     these activations following the application of pulsed and thermal Radiofrequency lesioning to~     the gasserien ganglion.~   "
19992|NCT03305276|"~     The present is an observational study conducted on the general population in villages of~     Southern Italy every year during the world hypertension day. So far, A total of 412 persons~     (193 males and 219 female, 14-85 years) were recruited during the XI and XII World~     Hypertension Day (2015 and 2016). The study was approved by the relevant institutional~     Ethical Committee of Salerno University.~   "
19993|NCT03305263|"~     Recurrent pregnancy loss (RPL) defined as 3 or more pregnancy losses affects approximately 3%~     of couples trying to achieve parenthood. Most cases of RPL are unexplained and have no~     effective treatment to improve the chance of a live birth. Exciting indications for using~     Hydroxychloroquine (HCQ) include: Malaria profylaxis and treatment, systemic and discoid~     lupus erythematosus (SLE) and rheumatoid athritis (RA). HCQ has been reported to have the~     following properties (anti-thrombotic, vascular-protective, immunomodulatory, improving~     glucose tolerance, lipid-lowering, and anti-infectious).~      There is no data concerning the benefit of HCQ in RPL. Administration for other indications~     provides extensive safety data during pregnancy.~      This study has the potential to establish support for a new treatment option for unexplained~     RPL.~   "
19994|NCT03305250|"~     Fabry disease (FD) is a genetic disorder that leads to progressive accumulation of fat or~     'sphingolipid' within the tissues, including the heart muscle and conductive tissue.~     Improvements in the detection of FD, together with more organised clinical services for rare~     diseases, has led to a rapid growth in the disease prevalence. Earlier and more frequent~     diagnosis of asymptomatic individuals before development of the disease itself has focused~     attention on early detection of organ involvement and closer monitoring of disease~     progression. Moreover, the introduction of enzyme replacement therapy within the last two~     decades has changed the natural history of FD as follows: a) increased life expectancy; b)~     improved morbidity; c) modification of the main cause of morbidity and mortality from renal~     (kidney) to cardiovascular (heart) events, including heart failure, abnormal heart rhythms,~     stroke and sudden death. Although symptoms such as palpitations and blackouts are extremely~     common, information on the frequency of proven abnormal heart rhythms is limited. In~     addition, the rate and appropriateness of implantation of life-saving devices is very~     variable, including pacemakers to boost the heart when too slow and cardio-defibrillators~     that stop the heart when too fast. The main markers of risk in similar diseases such as~     hypertrophic cardiomyopathy cannot be used in FD. While patients are routinely followed up in~     clinic with heart tracings and echocardiography (ultrasound of the heart), a recent small~     study has emphasised that these tests under-estimate the burden of abnormal heart rhythms in~     patients with advanced FD. The use of continuous heart monitoring with an implantable loop~     recorder (ILR) has led to a significant change in treatment in 13 out of 15 of FD patients.~     The investigators believe that more frequent use of ILRs will identify a greater need for~     change in therapy in many more patients than currently treated, with the aim of reducing~     morbidity and mortality in this patient cohort. In addition this will provide valuable data~     to inform an estimate of future risk for these patients.~   "
20021|NCT03304899|"~     Fibrinogen is a unique precursor of fibrin and cannot be compensated for by other coagulation~     factors. If plasma fibrinogen concentrations are insufficient, hemostatic clots cannot be~     formed with the appropriate firmness. In severe traumatic brain injury(TBI) patients, plasma~     fibrinogen concentrations decrease earlier and more frequently than other coagulation~     factors,predicting massive bleeding and death.~      The purpose of this study is to try early injection of fibrinogen concentrate in severe~     isolated traumatic brain injury and investigation the effect of it on post bleeding and~     complications.~   "
19995|NCT03305237|"~     This weight loss study will investigate the impact of calorie distribution across a day~     (large breakfast meals and smaller evening meals versus small breakfast meals and large~     evening meals) on body weight, and physiological and behavioral mechanisms regulating energy~     balance.~      Participants will undergo 2 x 4 week energy restriction protocols in a randomized cross over~     design; big breakfast (45% of calories in the morning meal, 20% at dinner) and big dinner~     (45% of calories in the evening meal, 20% at breakfast). We predict that timing of eating~     will influence energy balance, because morning energy expenditure is amplified in comparison~     to the evening. This study will allow us to assess whether the increased energy expenditure~     in the morning is linked to natural biological circadian rhythm or behavioral adaptions.~   "
19996|NCT03305224|"~     This study is to evaluate preliminary efficacy of Ra-223 in combination with Enzalutamide in~     progressive CRPC patients with bone metastasis~   "
19997|NCT03305211|"~     The NephoMIC project is a biological collection in patients of Nephrology, allowing the study~     of the links between kidney diseases, Immunity system and Cardiovascular complications.~      Its aim is to allow the development of a translational research on the theme of Systemic~     Nephrology, which concerns both renal complications of autoimmune and inflammatory diseases,~     and systemic complications of patients with kidney disease, linked to both a state of~     immunosuppression and an increased risk of cardiovascular complications.~      It is based on the proximity between the Clinical investigation Center (CIC) of the hospital,~     where the samples are received, techniqued and preserved, and the Center of Nephrology and~     Renal Transplantation of the hospital.~      The collection includes blood samples (whole blood, serum, plasma, total blood RNA, PBMC~     cells), and urine samples (fresh urine).~      Participation in the collection is particularly recommended for patients who require a~     medical renal biopsy in the Nephrology Department. Other well-phenotyped patients~     (well-defined renal disease diagnosis) may also participate in NephroMIC.~   "
19998|NCT03305198|"~     The measurement of the transcutaneous oxygen pressure during walking allows to estimate the~     importance of ischemia, bilaterally and segment of limb by segment of limb. The determination~     of the metabolic compounds concentration, with metabolomic approach, is emerging in~     physiology and exercise.~      This pilot study focuses on the feasibility of the metabolomics analysis with micro method ,~     by capillary drawing from earlobe sampling, for patients with peripheral artery disease (PAD)~   "
19999|NCT03305185|"~     The purpose of this study is to examine the effectiveness of Schroth scoliosis-specific~     exercises (SSE) on patients with adolescent idiopathic scoliosis (AIS) during bracing. The~     goal is to determine if Schroth SSE combined with bracing can is superior in controlling~     curve progression when compared with bracing alone. Curve progression is defined as worsening~     of coronal Cobb angle of 6 degrees or more.~   "
20000|NCT03305172|"~     The purpose of this study is to evaluate the effectiveness of different structures of long~     term financial incentives on increasing physical activity performed by subjects, as measured~     by the number of steps walked per day.~      Investigators are interested in studying whether physical activity increases during an~     intervention period (with incentives) and a post-intervention period (with no incentives).~   "
20001|NCT03305159|"~     Conduct a randomized control study to compare the tolerance of 4% chlorhexidine gluconate/4%~     isopropyl alcohol versus povidone iodine vaginal cleansing solutions for surgical~     preparations of the vagina. Patients will be randomized to either control (povidone iodine)~     or experimental (chlorhexidine gluconate), and then be given a short survey prior to and~     immediately after surgery, and again 24-48 hours via phone asking them about the presence and~     severity of vaginal dryness, burning, itchiness, unusual vaginal discharge, and pain or~     burning with urination.~   "
20002|NCT03305146|"~     The main objective of the study is to compare the diagnostic accuracy of intra-cystic fluid~     DNA molecular analysis to standard diagnostics.~      The secondary objective of the study is to evaluate the feasibility of intra-cystic fluid DNA~     molecular analysis.~   "
20003|NCT03305133|"~     Observational, multicentre, retrospective study on patients taken care according to the~     national guidelines. The objective is to define, after the diagnosis confirmation, the~     frequency of PD-L1 expression in patients with large-cell lung neuroendocrine carcinoma~     (NEC), whatever the stage of the disease, and to correlate this parameter to clinical data at~     the time of diagnosis, therapeutic response and survival. Large-cell NECs present a bad~     prognostic and there is no evidence of treatment for these patients with advanced disease in~     second ligne of treatment at that time. To demonstrate the PD-L1 expression in this type of~     cancer might have a major therapeutic impact in a close future to access immunotherapies.~   "
20004|NCT03305120|"~     The endometriosis is defined by the presence of endometriosic tissue outside of the womb and~     the prevalence is estimated to be 10% of women.Here is a project aimed to compare~     musculo-scrawny pains between patients with endometriosis and whose don't suffer of this~     pathology;~   "
20005|NCT03305107|"~     The purpose of this study is to determine the separate and combined effects of high-intensity~     interval exercise and chocolate milk on glycemic response, cognitive function, subjective~     appetite, and salivary cortisol among children aged 9-13 year old children.~   "
20006|NCT03305094|"~     The study objective is to verify if a non-invasive remote ischemic preconditioning procedure~     (blood pressure cuff on the arm) is cardioprotective when applied before an aortic valve~     replacement surgery.~   "
20007|NCT03305081|"~     This a randomized control trial to identify if patients who desire LARC are more likely to~     have success receiving the desired form of contraception if it is placed a) during the~     postpartum hospital stay, either in the immediate or early postpartum period, versus b)~     during the interval postpartum period as previously done.~   "
20022|NCT03304886|"~     Purpose of the study is to assess the diagnostic accuracy of an on- line questionnaire in~     comparison to a semi-structured interview administered by a trained interviewer.~   "
20166|NCT03303001|"~     The shoulder pain is commonly seeing in orthopedic consultation. Many patients was affected~     in activities of daily living and in laborer absent. One of the first treatment lines is the~     steroid infiltration for pain relieve, however in several times is only effective by a short~     period of time, and the symptoms usually appear again. One of the not known infiltration is~     the high volumen infiltration in subacromial space, this treatment appears to be an effective~     treatment for this patients.~   "
20008|NCT03305068|"~     Hypothesis It is expected that shoulder surgery patients treated with celecoxib (Celebrex)~     will experience significantly reduced narcotic use as measured by pill count compared with~     controls at three and six weeks postoperatively.~      Study Overview The proposed study will determine if there is benefit to the use of a COX-II~     inhibitor in shoulder surgery. This study will have two arms: Arm 1 (shoulder replacement,~     both primary and reverse) and Arm 2 (arthroscopic rotator cuff repair). These distinct arms~     are necessary because each surgery is distinct in terms of type of procedure, indications,~     and patient population. The patients in Arm 1 will undergo stratified randomization according~     to the type of arthroplasty (primary or reverse) to ensure a balanced representation of these~     patients within subgroups. All patients undergoing primary total shoulder replacement,~     reverse shoulder replacement, or arthroscopic rotator cuff repair will be eligible to~     participate in the appropriate arm of the study. Revision surgery patients will be excluded~     from both arms of the study. A maximum of 78 arthroscopic cuff repair patients, and 78~     arthroplasty patients will be enrolled in each arm of the study. Baseline information will be~     obtained on each patient including baseline VAS for pain, baseline shoulder scores as~     outlined below, and baseline narcotic and anti-inflammatory medication use, if any. Patients~     will be randomized to receive celecoxib (Celebrex) 400 mg one hour prior to surgery or~     placebo; they will then continue to receive the same medication daily for 3 weeks~     postoperatively: celecoxib 200 mg twice daily or a placebo control. The primary outcome~     measure will be narcotic utilization as measured by narcotic pill count. Secondary outcome~     measures will include subjective measure of pain as measured by the VAS for pain, range of~     motion as measured by active forward elevation (at 6 weeks postoperatively) and three patient~     assessment scores: the Simple Shoulder Test (SST), the UCLA score, and the American Shoulder~     and Elbow Society score (ASES). Data will be obtained at follow-up visits three and six weeks~     postoperatively.~   "
20009|NCT03305055|"~     The Ketamine for Acute Pain in Burns study is a randomized, double-blind, parallel group~     trial (RCT) with active control (usual care) contrasting the efficacy and safety of Ketamine~     Plus Opiate-based usual care (O+K) with the safety and efficacy of the Current Standard of~     Care. THe current standard of care is an opiate medication alone, Fentanyl (Usual~     Care-Opiate (UC-O), dose/timing as per Burn Center protocol).~   "
20010|NCT03305042|"~     Minimal human data exist on actual liver vitamin A compared with blood biomarkers. One blood~     biomarker, the percent of total serum retinol (vitamin A) in the form of retinyl esters, has~     been suggested to diagnose hypervitaminosis A with cutoffs of 5% and 10%. In this study,~     investigators aim to compare total liver vitamin A reserves with the percent total serum~     retinol as retinyl esters to evaluate hypervitaminosis A using autopsy samples from US~     adults. Investigators also evaluate the sensitivity (the ability of the biomarker to~     correctly identify those with deficiency) and specificity (the ability of the biomarker to~     correctly identify those without deficiency) of serum retinol to determine vitamin A~     deficiency, variation of liver vitamin A concentration among lobes, and liver alpha retinyl~     ester concentrations, a cleavage product of alpha-carotene, a vitamin A precursor. To conduct~     the study, matched serum and liver samples were procured from 27 US adult cadavers (from~     donors age 49-101 years) and their vitamin A biomarkers were analyzed.~   "
20011|NCT03305029|"~     To evaluate the safety and tolerability of human somatic cell nuclear transfer embryonic stem~     cell derived retinal pigmented epithelial(SCNT-hES-RPE) cellular therapy in patients with~     advanced dry AMD~   "
20012|NCT03305016|"~     A 26 week trial of TransCon hGH, a long-acting growth hormone product, administered~     once-a-week. Approximately 150 children (males and females) with growth hormone deficiency~     (GHD) will be included. All study participants will receive TransCon hGH. This is a global~     trial that will be conducted in, but not limited to, the United States, Canada, Australia,~     and New Zealand.~   "
20013|NCT03305003|"~     Throughout the Military Health System, pregnant mothers are issued a spiral-bound guide that~     provides week by week information about pregnancy, preventive health messages, appointment~     information, and space to record their experiences throughout their pregnancy. When used~     accordingly, the evidence-based guide is an effective tool for motivating patients to~     participate in their own healthcare and achieve care goals. However, the spiral-bound paper~     modality results in patients forgetting the book for appointments or losing it. By testing a~     mobile application (app) from the current publication, the MHS leverages the efforts which~     created the guide while increasing patient and provider use.~      The multisite testing (randomized controlled trial) of a mobile application developed from~     the current spiral-bound Pregnancy and Childbirth: A Goal Oriented Guide to Prenatal Care~     created by the VA and DoD provides an innovative, cost-effective opportunity to improve~     provider-patient communication and patient care.~   "
20014|NCT03304990|"~     PRECISE is a study to discover new detection, prognosis and treatment biomarkers for cancer.~     This is a prospective, multi-center, observational study designed to collect de-identified~     biospecimens and clinical data from a large cohort of participants from clinical research~     networks in the United States. In this study, the investigators propose creating a~     large-scale normalized panomics dataset specifically designed for deep learning-based in~     silico analysis for biomarker discovery.~   "
20015|NCT03304977|"~     Oral antigoagulant are used more than 60 years in thrombotic diseases. Even they are~     indispensable, the haemorragic risk is high.That's why it's the main reason of~     hospitalization for iatrogeny.The complication's reasons are mainly linked to errors of drug~     intake, drugs interaction and the lack of understanding the treatment.Moreover, the~     antiplatelet agglutening treatment is frequently added to anticoagulant treatment.This~     increases the haemorragic risk.Different means were used to minimize the risk , like INR~     follow up.~      The purpose of the study is to evaluate smartphone use to follow the patients'treatment.~   "
20016|NCT03304964|"~     This is a single-center, phase I study consisting of 2 parts. The first part is a multiple~     ascending dose (MAD) part with a randomized, double-blind, placebo-controlled design in 3~     treatment groups of 8 subjects (6 active; 2 placebo). The second part is a food effect (FE)~     part with a randomized, open-label, 2-period, 2-way crossover, single dose design in 8~     subjects.~   "
20017|NCT03304951|"~     The primary objective is to evaluate clinical data related to the safety and performance of~     the Sinopsys® Lacrimal Stent.~   "
20018|NCT03304938|"~     Considering the high prevalence of sleep disturbance in diabetic patients and the~     effectiveness of lavender in treatment of sleep disorders in this study the efficacy of~     Lavender aromatherapy in sleep disorder and metabolic parameters in diabetic patients will be~     investigated. This study is designed as cross-over double-blind placebo-controlled randomized~     clinical trial that 40 diabetic patients with sleep disorder with the inclusion criteria will~     enter into the study and randomly assign to first intervention and first placebo groups.The~     primary outcomes are change in sleep disorder and metabolic parameters that will be evaluated~     at the end of the study.~   "
20019|NCT03304925|"~     Evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction in the~     flanks.~   "
20020|NCT03304912|"~     Pre-exposure prophylaxis (PrEP) is a promising bio-medical HIV prevention strategy that~     involves the use of single daily dose of emtricitabine/tenofovir disoproxil fumarate~     (FTC/TDF) by HIV-negative individuals to reduce risk of acquiring HIV. Evidence suggests~     women who inject drugs (WWID) are disproportionately vulnerable to HIV. If HIV incidence~     continues unchecked, 1 in 23 WWID in the United States will acquire HIV. One concern~     regarding PrEP implementation for WWID is that they will face a number of challenges to~     engaging in PrEP care. To reduce barriers and thereby increase the individual and public~     health benefits of PrEP, alternative approaches based outside of traditional clinical~     settings are needed. The proposed research is significant, because PrEP could reduce HIV~     acquisition among WWID. However, at present, there is little knowledge to help address PrEP~     implementation challenges for this understudied group. The proposed research is highly~     innovative, because it will address this knowledge gap by evaluating a novel approach for the~     delivery of PrEP care: pairing PrEP with community-based syringe exchange program (SEP)~     services. This approach may represent a paradigm shift that enables and encourages women in~     this highly vulnerable population to engage in effective biomedical HIV prevention~     strategies. The rationale is that (1) SEPs may currently provide prescription medications and~     long-term monitoring for other conditions such as buprenorphine for opioid dependence, so~     providing PrEP care is a natural extension of what is already being done successfully; (2)~     SEPs are a viable access point for many HIV-uninfected WWID who would be considered eligible~     for PrEP under current clinical guidelines; and (3) PrEP interventions, delivered in settings~     already utilized and trusted by WWID, will increase uptake, adherence and retention in PrEP.~     To evaluate this approach, a prospective mixed methods study will be initiated within the~     largest SEP in the mid-Atlantic region. Through semi-structured and in-depth interviews based~     on the Behavioral Model for Vulnerable Populations, and drug-level monitoring for FTC/TDF~     adherence, the following specific aims will be addressed: (1) Describe WWID's engagement in~     the PrEP care continuum (focusing on critical moments when women could disengage or need~     additional support to remain in care). (2) Identify factors from the BVMP that are associated~     with WWID's engagement in the PrEP care continuum. (3) Explore how and why model factors are~     associated with WWID's decisions and ability to engage in PrEP care. A paired model of PrEP~     and SEP services has yet to be tested. This is exploratory study will provide preliminary~     data to generate hypotheses for future intervention studies. The long-term outcome of this~     research program will be a reduction in HIV among WWID through the delivery of HIV prevention~     interventions that include PrEP. The reproducibility of this approach, resulting from~     utilization of an already functional service delivery system, significantly increases the~     potential for translation to other settings and PWID populations, including men who inject~     drugs, in domestic and global contexts.~   "
20425|NCT03299621|"~     The evaluation of the anesthetic depth monitoring using PLE (Phase Lag Entropy) during~     propofol anesthesia~   "
20023|NCT03304873|"~     The purpose of this study is to investigate the efficacy of retapamulin to reduce carriage of~     MRSA via a randomized, double-blind, placebo-controlled clinical study testing retapamulin~     among patients with confirmed mupirocin-resistant nasal and/or rectal MRSA colonization. The~     sample size will include 27 subjects in each of the two arms of the study (retapamulin versus~     placebo) for a total of 54 subjects. Participants who are found to be nasal and/or rectal~     colonized with MRSA will be randomized to receive either retapamulin or placebo applied~     nasally and rectally for a total of 5 days. Nasal and rectal swabs will be collected at~     pre-defined time points during study duration (screening swab, swab one week after completion~     of topical therapy, swab 4 weeks after completion of topical therapy) to assess MRSA~     colonization status. The colonization rates of both groups will be assessed via Fisher's~     Exact Test.~   "
20024|NCT03304860|"~     Physician recommendation has been shown to be one of the most significant predictors for~     colorectal cancer (CRC) screening. This study aims to identify the amount of parents of~     internal medicine residents at NYU who are eligible for CRC screening but have not received~     it. Investigators will perform an intervention and quantify the amount of parents eligible~     for CRC screening after the intervention. This study will entail sending 2 brief surveys (one~     before the intervention and one after) which determine if the parents of the residents are~     eligible for CRC screening. The intervention will be asking the residents with eligible~     parents to have a discussion with their parents about CRC screening options and to address~     their concerns. Investigators will provide a one page document the residents can give their~     parents as a reference as part of the intervention.~   "
20025|NCT03304847|"~     This study assesses the value of arrhythmogenic substrate identification and elimination by~     catheter ablation to prevent recurrent ventricular arrhythmias and sudden cardiac death in a~     series of selected patients with primary cardiomyopathy and ICD implantation.~   "
20026|NCT03304834|"~     This is a single-center prospective study with a planned accrual of 35 patients with~     diagnosed symptomatic Lower Limb Veins System (Superficial, Perforating) Insufficiency~     (including recurrence at the thigh/groin level after previous treatment). The eligible~     patients must present a symptomatic Leg Veins System Insufficiency diagnosis which fulfills~     the inclusion/exclusion criteria. All patients will be consented at a Pre-Study Visit and~     evaluated for eligibility and for baseline characteristics of the disease. Patients will~     return to clinic on a separate day for the HIFU treatment. Device performance parameters will~     be collected during the HIFU visit. At follow-up visits at 3 days, 7 days and 3 months,~     changes in veins and flow characteristics will be evaluated by ultrasound and physical exam,~     and patient well-being, including pain and anxiety, will be evaluated by patient-reported VAS~     evaluations. Continued follow-up for a total of 3 months will be completed prior to subject~     study exit. Adverse events (AE) will be assessed at every study visit following HIFU~     treatment. An interim Safety Report will be issued after the first 5 patients will arrive at~     the 7 days visit and will be provided to the Ethics Committee. A second report will be issued~     once the first 5 patients will complete the follow-up period of 30 days and will be also~     provided to the Ethics Committee.~   "
20027|NCT03304821|"~     Peripheral artery disease (PAD) is a disease in which plaque builds up in the arteries that~     carry blood to the head, organs, and limbs. PAD usually occurs in the arteries in the legs,~     but can affect any arteries. Over time, plaque can harden and narrow the arteries which~     limits the flow of oxygen-rich blood to organs and other parts of the body. Blocked blood~     flow to the arteries can cause pain and numbness. The pain is usually worse with exercise and~     gets better with rest. PAD can raise the risk of getting an infection which could lead to~     tissue death and amputation. This study is investigating whether granulocyte-macrophage~     colony stimulating factor (GM-CSF) improves symptoms and blood flow in people with PAD.~     GM-CSF is a drug that is used to stimulate the bone marrow to release stem cells.~     Participants in the study will be randomly selected to receive GM-CSF or a placebo. After a~     four-week screening phase, participants will receive injections of GM-CSF or a placebo three~     times a week for three-weeks. Three months later, participants will again receive injections~     of GM-CSF or placebo three times a week for three-weeks. At six months, the study team will~     follow up to see if the group that received GM-CSF had more improvement than the group that~     received placebo.~   "
20028|NCT03304808|"~     The present study included 57 patients ≥18 years who met diagnostic criteria for PE including~     intravaginal ejaculatory latency time (IELT) of ≤2 minutes and had a Premature Ejaculation~     Diagnostic Tool (PEDT) score ≥11.~      Subjects were randomized to an experimental group that used the device with exercise~     programme (n=18) a first control group that only used the exercise programme (n=17) and a~     wait-list control group (n=22).~      As a main outcome measure used stopwatch-measured average IELT, Premature Ejaculation Profile~     (PEP), and the Golombok-Rust Inventory of Sexual Satisfaction (GRISS).~   "
20029|NCT03304795|"~     Vitamin D deficiency has become one of the most prevalent health problems in modern society.~     However, there has been no study that has reported the trend of vitamin D status in Asia.~     This study investigated the trend of vitamin D status in Korea between 2008 and 2014.~      This study is based on a representative national database acquired from the Korea National~     Health and Nutrition Examination Surveys (KNHANES) conducted from 2008 to 2014. Serum~     25-hydroxyvitamin D [25(OH)D] levels were measured by radioimmunoassay among those aged 10~     yrs or older. The temporal change of vitamin D status will be statistically analyzed.~   "
20030|NCT03304782|"~     Almost half of all deliveries in the United States are of nulliparous patients. They have~     been identified as an at-risk population for preterm birth. Historically, the most~     significant risk factor for preterm birth is a prior history of preterm birth, which cannot~     be applied to a nulliparous population. Forecasting adverse outcomes in first time moms is~     difficult to predict and prevent. Historically, physicians have prescribed a restriction in~     activity level for those at risk for preterm delivery. The utility of this intervention has~     yet to be prospectively and quantitatively studied. The Fitbit activity tracker is a wearable~     device that has been extensively used in medical research, in an attempt to quantitatively~     identify how patient activity levels can improve medical outcomes. The study uses the Fitbit~     device in nulliparous patients, remotely track their activity levels throughout pregnancy,~     and assess pregnancy outcomes. Because of the significant and long-standing health disparity~     in the incidence of preterm delivery, the investigators will use the Everyday Discrimination~     Scale, a validated battery of racism and health to see how a patient's stress related to~     perceived discrimination may modify the risk of preterm delivery.~   "
20031|NCT03304769|"~     This study aims to prospectively investigate the use of virtual reality headsets on the~     placement of IVs in a pediatric emergency department, by comparing the first stick success~     rate, total number of attempts, and the time to successful IV placement between patients who~     use virtual reality headset technology during the placement and those who receive the~     standard of care IV placement when child life ( individuals with special training in aiding~     and augmenting pediatric coping skills) is not available. The investigators will also compare~     the patient and parent perception of pain and anxiety associated with the IV placement in~     both study groups. Finally, by detailing which medications have been given prior to use of~     the VR for IV placement the investigators may evaluate for possible synergistic effects of VR~     with prior medication administration.~   "
20032|NCT03304756|"~     This is a single arm, single center, non-randomized, phase II trial of stage IIB/III TNBC.~     Patients received neoadjuvant chemotherapy with cisplatin (50 mg/m2) in combination with~     doxorubicin (50 mg/m2) and cyclophosphamide (500 mg/m2) every 21 days and for a total of 6~     cycles. After surgery, adjuvant chemotherapy consisting of docetaxel (75 mg/m2) every 21 days~     was further provided for 4 cycles. Primary outcome was pathological complete response in the~     breast and axilla (pCR; ypT0ypN0). Secondary outcomes were safety, disease-free survival and~     overall survival.~   "
20033|NCT03304743|"~     Osteoporosis is a common disease that makes the bones fragile and easy to break. Osteoporotic~     fractures are a serious health problem resulting in pain, reduced mobility, increasing degree~     of dependence and sometimes death.~      Osteoporosis is currently diagnosed by measuring bone density at the hip/spine through an~     exam called DXA. Although all post-menopausal women are at higher risk, currently Italian~     national guidelines do not recommend population-screening programs. This leads to several~     cases not being identified before a fracture occurs.~      Since dental panoramic radiographs (OPGs) are common procedures during dental check-ups or~     before dental treatments, it would be of great value if dentists could use them to identify~     people with unknown osteoporosis and early refer them to a specialist before they fracture.~      This study aims to test if it is meaningful to use OPGs to screen for post-menopausal~     osteoporosis. In particular, it will inform on how many undiagnosed osteoporotic women attend~     a Dental Hospital, how willing they are to have a DXA scan after a dental appointment and how~     precise the OPGs are as screening tools.~      124 post-menopausal women will be recruited, which will undergo an OPG and a DXA scan to~     check their bone density.~   "
20034|NCT03304730|"~     Magnet Resonance Image findings of facet osteoarthritis and patient characteristics are~     prognostic factors for improvement or worsening of the clinical outcome after treatment with~     facet infiltration.~   "
20035|NCT03304717|"~     The overall objectives are to explore the safety and efficacy of Reverse Transcriptase~     Inhibitors Tenofovir (TDF)/ Emtricitabine (FTC) administered for six months in AGS affected~     children 2 to 18 years of age.~   "
20036|NCT03304704|"~     Background:~      Half of the world's population is at risk of malaria. Malaria is a disease that affects many~     people in Mali and other parts of Africa. It is caused by germs spread by mosquito bites.~     Malaria may be mild. But it can also be serious or can lead to death if it is not diagnosed~     and treated promptly. Researchers want to learn more about the disease so they can develop~     new approaches to malaria control.~      Objective:~      To collect data on how mosquitoes spread malaria and how many people get malaria in the~     community by comparing different areas, seasons, and years.~      Eligibility:~      Residents of a certain area of Mali who are of any age~      Design:~      Participants will be screened with a physical exam and medical history.~      All participants will have at least 1 visit. They will answer questions about their health~     and malaria. They may have a physical exam. They will have blood collected.~      Some participants will have 1 visit every month for 3 years. They will repeat the procedures~     above.~      These participants will have mosquitoes collected in their home monthly. They may be able to~     catch some of the mosquitoes alive or may need to use a spray to kill the mosquitoes.~     Participants in this part of the study can be up to 65 years old.~      Some participants will also have about 60 mosquitoes directly feed on their arm or leg for~     15-20 minutes each month. These participants must be 5-65 years old.~   "
20037|NCT03304691|"~     Background:~      Malaria is caused by parasites carried by some mosquitos. When the mosquitos bite people, the~     parasites can infect them. One of these parasites is Plasmodium vivax (P. vivax). Some~     children have P. vivax in their blood. They did not have malaria symptoms, but some also had~     a blood problem called anemia. This can make people feel tired or weak. This could have been~     caused by P. vivax. Researchers want to know how P. vivax infects these children, and if it~     affects their health.~      Objective:~      To collect blood, stool, and urine monthly from children to look for infections with P.~     vivax, worms, and other parasites.~      Eligibility:~      Children between 6 months and 10 years old~      Design:~      For screening, the study will be explained to the participant s parents or guardians, who~     will provide consent.~      Participants will have a visit once a month for about 3 months, from November to January, and~     then for about 6 months from June to November 2018. Visits include:~      Questions about their health~      Medical history~      Physical exam~      Blood draw by pricking the finger tip~      Urine and stool collection. They may collect these at home and bring them back.~      If participants have P. vivax in their blood, them may need to come back to the clinic within~     3 days. They will have blood taken from their arm using a needle.~      If participants feel ill during the study, they can go to the clinic for an exam and blood~     tests.~      If participants develop malaria while on the study, they will be treated.~      Participants samples will be stored for future research studies.~   "
20046|NCT03304574|"~     During adolescence, the most common causes of morbidity and mortality are related to risky~     behaviors. The American Academy of Pediatrics recommends that adolescents be screened for~     these behaviors during primary care visits, but many adolescents do not receive the~     recommended risk behavior screening and counseling, in part because they are infrequently~     seen in primary care. The objective of this study is to evaluate if the electronic health~     screening tool, which includes an electronic health assessment with integrated personalized~     feedback, reduces risk behaviors in adolescents seen in the Emergency Department (ED).~   "
20047|NCT03304561|"~     Quadriceps and hamstring muscle strenghts have important role in returning to sport after ACL~     reconstruction and one of the main focus of rehabilitation is to improve strenght of these~     muscles. With the strenghtening of the contralateral limb (cross-over training) we aimed to~     improve the strenght of the quadriceps~   "
20038|NCT03304678|"~     Background:~      Lymphangioleiomyomatosis (LAM) is a rare, progressive disease. It usually affects women in~     the prime of their lives. It typically results in lung destruction. Studies have shown that a~     drug called sirolimus stabilizes lung function in people with LAM. But researchers do not~     know what drug dose and blood serum levels are needed to reach this stability. Researchers~     want to learn more about the right dose of sirolimus for people with LAM.~      Objective:~      To determine if blood and urine markers after 1 dose and again after 3 months can be used to~     evaluate the correct dose of sirolimus for people with LAM.~      Eligibility:~      Women ages 18-90 with LAM whose doctors have decided they should start taking sirolimus to~     treat it.~      Design:~      At visit 1, participants will take their first dose of sirolimus by mouth at the clinic. They~     will have blood and urine collected.~      Participants will take 1 tablet of the study drug each day.~      Visit 2 will be 3 months after visit 1. Participants will have blood and urine collected.~      Participant samples will be stored in a secure place. No personal data will be connected to~     them.~   "
20039|NCT03304665|"~     Objective: To screen and create a list of adult volunteers in good health for participation~     in research studies conducted at the National Institutes of Health (NIH) in Bethesda,~     Maryland. Develop a normative set of structural and functional brain MRI scans that are~     linked to healthy research volunteer characteristics. Maximize scientific impact of data from~     volunteers by broadly sharing with other researchers.~      Study Population: Adult males and females in general good health who are 18 years of age and~     older.~      Design: Adult individuals who are interested in participating in NIMH IRP clinical studies as~     a healthy research volunteer can directly visit or be directed to visit the study website~     where they will first consent electronically and then complete a set of online self-report~     measures. Items may include: demographic information, mental health symptoms, disability~     status, substance use patterns, handedness and clinical/family history. Individuals who are~     flagged based on predetermined responses to survey items will be further screened by a member~     of the study clinical team. If found to be ineligible for the study because of a clinically~     significant or unstable medical or mental health condition, these individuals will be~     referred back to the community and/or given information about NIMH clinical studies for which~     they may be eligible. Respondents with no flags or who pass through additional screening will~     be scheduled for an in-person assessment. During the outpatient appointment and after~     in-person informed consent, participants will receive a brief clinical interview to screen~     for current medical and mental conditions, and risk for self-harm. They will complete~     assessments of psychological, emotional, physiologic, biological and cognitive functioning.~     Participants will undergo a physical exam and be asked to provide blood and urine samples for~     routine clinical labs as well as additional blood samples for future secondary analysis that~     could include genetic or biomarker assays. Participants can separately consent for an~     optional baseline brain magnetic resonance imaging (MRI) scan. All consent forms will~     explicitly inform participants that if enrolled in the study, their de-identified data will~     be broadly and publicly shared through NIH-approved data repositories. Participants in this~     recruitment and characterization study will then be placed on a list of healthy research~     volunteers from which other NIMH IRP studies may recruit according to the inclusion and~     exclusion criteria in their respective IRB-approved protocols.~      Outcome Measures: Outcome measures may include demographic data, mental and medical history~     and symptoms, results of psychological, emotional, physiologic, biological, and cognitive~     testing, physical exam and MRI findings.~   "
20040|NCT03304652|"~     Recent studies in animal models have suggested a critical role for cerebrospinal fluid and~     Interstitial fluid flux through cerebral parenchyma for removal of byproducts of cellular~     metabolism and hence in maintaining the health of the brain. This effect is modulated during~     sleep, suggesting a potentially important mechanism for sleep to maintain both acute~     homeostasis and long-term cerebral health.~      The central goal of these studies is to develop a sensitive MRI biomarker of cerebral~     conformational changes during sleep. This exploratory work aims to establish the sensitivity~     and reproducibility of MRI as a non-invasive neuroimaging assessment of cerebral changes~     during natural sleep and sedation.~   "
20041|NCT03304639|"~     This randomized phase II trial studies how well pembrolizumab with or without stereotactic~     body radiation therapy works in treating patients with merkel cell cancer that has spread to~     other places in the body. Monoclonal antibodies, such as pembrolizumab, may interfere with~     the ability of tumor cells to grow and spread. Stereotactic body radiation therapy is a~     specialized radiation therapy that sends x-rays directly to the tumor using smaller doses~     over several days and may cause less damage to normal tissue. Giving pembrolizumab with~     stereotactic body radiation therapy may work better in treating patients with merkel cell~     cancer.~   "
20042|NCT03304626|"~     This is a pilot study that investigates the efficacy and safety of budesonide as an immune~     suppressing agent for liver transplant recipients in the early post-transplant period.~      The primary end-point is rates of acute cellular rejection within first 24 weeks post-liver~     transplant. Secondary end points include rates of new onset diabetes after transplant and~     safety of budesonide.~      The study is structured as a prospective clinical trial. After receiving 4 days of~     intravenous corticosteroids on liver transplant post-operative days 0 through 3, subjects~     will be started on standard immunosuppression plus enteric coated budesonide (study drug) in~     place of standard immune suppression plus prednisone (standard of care). Study drug will be~     tapered over 12 weeks in accordance with the existing standard of care immune suppression~     protocol. Subjects will be followed in outpatient transplant clinic for 24 weeks. The purpose~     of the study is to conduct a pilot study to generate rates and effect size that can be used~     in a subsequent equivalent trial. A total of 20 subjects will be enrolled to receive the~     standard immunosuppression plus budesonide and their outcomes will be compared to 20 controls~     receiving standard immunosuppression plus prednisone (standard of care). The use of controls~     is to generate rate and variability that can be compared with the rate obtained from patients~     that receive study drug by examining the 95% confidence band.~   "
20043|NCT03304613|"~     The investigators will conduct a randomized controlled trial of an 8-week resilience-enhanced~     CBT online self-management program for chronic pain plus usual care (PRISM), standard e-CBT~     self-management plus usual care (e-CBT), and usual care alone. Thus, 300 individuals with~     chronic pain will undergo a comprehensive pre-intervention assessment that includes a blood~     draw (T1). Participants will then be randomized 2:2:1 as follows: e-CBT (n=120), PRISM~     (n=120) and usual care (n = 60). Immediately post-intervention (T2) and at 6 months (T3) and~     12 months (T4) after that, participants undergo the same in-person assessment including blood~     draw. Telomerase activity will be assessed at T1, T2 and T3; and telomere length at T1 and T4~   "
20044|NCT03304600|"~     It's a multicentric, randomized, controlled study concerning 100 patients with~     treatment-resistant obsessive compulsive disorders (OCD). The aim of this study is to~     evaluate the effect of transcranial direct current stimulation (tDCS) on OCD patients.~   "
20045|NCT03304587|"~     This study will implement therapeutic bright light that is tailored to the individual's~     circadian typology and will estimate its effects on circadian rhythms, 4 common~     cancer-associated symptoms, and impact on quality of life in survivors living with cancer.~     Examining a selected phase marker (core body temperature) in relation to the associated~     clinical features (symptoms) is the starting point for future investigation of the biological~     mechanisms of symptoms.~   "
20048|NCT03304548|"~     GlaxoSmithKline (GSK) is embarking on a clinical program to assess the treatment of PAH with~     an Angiotensin converting enzyme 2 (ACE2). This new treatment may require subcutaneous~     administration, in comparison to current treatments which are taken orally. Hence, GSK would~     like to conduct this qualitative interview study with PAH subjects to explore subject's~     perspective and preferences for various modes of treatment administration (daily or weekly~     subcutaneous injection versus current treatment options). This will be a qualitative study~     comprising the conduct of semi-structured telephone concept elicitation interviews with 8 to~     10 PAH subjects (each approximately 30 minutes in duration) in the United States (US).~   "
20049|NCT03304535|"~     The purpose of this research study is to determine whether involvement with a social worker~     helps reduce distress, depression, and increase patient activation in participants over a 6~     month intervention period. The study will also describe common barriers to care that~     participants face.~   "
20050|NCT03304522|"~     This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, multicenter~     study evaluating the efficacy of VX-150 for the treatment of pain caused by small fiber~     neuropathy~   "
20051|NCT03304509|"~     This is a parallel group clinical trial comparing two types of follow-up in patients operated~     and treated in a General and GI surgery department. Face-to-face vs telematic follow-up by~     using a platform that offers videoconferencing will be compared.~      Patients will be included and assigned randomly to each group using an informatics program~     until 100 patients are reached in each arm of the study (n total = 200 patients) The main~     and secondary outcomes will be evaluated 30 days after the date of the follow-up.~   "
20052|NCT03304496|"~     Femoral artery approach to perform coronary procedures is considered the standard technique~     for vascular access due to optimal catheter control, lower thromboembolic complications and~     immediate access due to the large diameter of the artery. Trans-radial approach has been~     shown to reduce major bleeding complications, vascular complications related to the site of~     puncture, including death from all causes, and to prevent post-procedure limb rest, greater~     comfort for patients, immediate ambulation, early discharge and reduction of costs. Previous~     studies have shown that intravenous, topical and intraarterial use of nitroglycerin produces~     vasodilation of the radial artery. Extravascular (subcutaneous) administration of~     nitroglycerin is extremely effective in restoring the radial pulse, and allows adequate~     cannulation.~   "
20053|NCT03304483|"~     The aim of this study is to examine the cardiovascular effects of ultramarathon running and~     their relation to performance.~   "
20054|NCT03304470|"~     This is a Phase 2, 3-week, single-center, double-blind, randomized, two-arm, vehicle~     controlled study, with each individual receiving both active and vehicle treatment.~     Approximately 30 subjects with moderate atopic dermatitis will receive topically applied~     ATx201 CREAM 2% and matching vehicle once daily for 3 weeks (5 mg/cm2/day), without~     occlusion. ATx201 and vehicle will be applied on two separate target lesions of moderate~     atopic dermatitis (lesions of at least 3 × 3 cm, excluding the face, scalp, genitals, hands,~     and feet, ideally from the same anatomical location).~   "
20055|NCT03304457|"~     Schizophrenia (SCZ) is a chronic, severe and disabling mental disorder with unclear etiology~     and pathophysiology concerned with neuro-developmental,neurodegenerative abnormalities and~     cognitive impairmentslinked to behavioural changes.According to neurotrophic hypothesis, the~     changes result due to the abnormal regulation of neurotrophic factor, especially the~     decreased serum brain derived neurotrophic factor (BDNF) validated by several meta-analyses.~     However, the regulation of nerve growth factor (NGF) in SCZ remains unclear because of the~     inconsistent findings from the previous clinical studies.~      Lurasidone is a novel antipsychotic drug approved for adult SCZ and for affective~     symptomatology & cognitive deficits. Principal advantages over some other second-generation~     antipsychotics are its highly favourable metabolic profile and once daily dosing regimen.~     Some of the studies indicate that risperidone, olanzapine, clozapine & aripiprazole might not~     alter BDNF levels, at least within 8 weeks of treatment.While other two studies with~     olanzapine suggest that BDNF might influence the response to monotherapy in SCZ patients.All~     these previous studies are non-conclusive & contradictory to each other which draw our~     attention for doing the research further to reach a conclusive result about the effect of~     olanzapine and lurasidone on neurotrophic biomarkers in SCZ.~   "
20056|NCT03304444|"~     This study evaluates the comparison between liposomal bupivacaine versus bupivacaine HCl in~     Transversus Abdominis Plane blocks for gynecologic surgery on the length of stay in the~     hospital, total narcotic use, and overall complications rates.~   "
20057|NCT03304431|"~     In patients undergoing coronary bypass surgery; 10% topical lidocaine administered~     endotracheally before intubation is to investigate the effect of hemodynamic response and EKG~     paramater after intubation.~   "
20058|NCT03304418|"~     This is a phase IIa, open label, single arm, and prospective study of hormone therapy-naïve~     men with oligometastatic prostate cancer to the bone. The study will test if treating the~     primary tumor sites and 5 or fewer sites of bone-only metastasis with external beam radiation~     with concomitant systemic Radium-223 will reduce the utilization of androgen deprivation~     therapy, improve QOL and improve OS over a the comparator cohort of SWOG intermittent ADT~     historic cohort.~   "
20059|NCT03304405|"~     This study intends to investigate the changes in gait pattern in adult spinal deformity (ASD)~     patients with sagittal imbalance. It will investigate the gait kinematics in patients who~     have a mismatch of their spinopelvic parameters, and a positive sagittal balance. The~     investigators hypothesise that patients with abnormal spinopelvic parameters may demonstrate~     a pathological gait pattern.~   "
20073|NCT03304223|"~     After renal transplantation 5 to 10% of patients experience allograft rejection. Rapid and~     accurate diagnosis is vital for implementation of additional immunosuppressive therapy.~     Currently, a renal biopsy is essential for the diagnosis of renal allograft rejection.~     However, this is an intervention associated with complications like bleeding, patient~     discomfort and hospital admission. Additionally, limited biopsy sample size may lead to false~     negative results. So, the introduction of a new non-invasive diagnostic tool for allograft~     rejection could have major implications for the care of renal transplant recipients. For the~     purpose of visualizing infiltrating T lymphocytes with positron emission tomography (PET),~     the tracer 18-Fluor-Interleukin-2 ([18F]FB-IL2) has been developed. The investigators~     hypothesized that a high correlation exists between [18F]FB-IL2 uptake and the extend of T~     cell infiltration into renal transplants with signs of rejection~   "
20060|NCT03304392|"~     Depression and anxiety are prevalent and disabling conditions that often go untreated.~     Internet-delivered Cognitive Behaviour Therapy (ICBT) is a relatively new approach to~     treatment that is a convenient way for patients to access care. ICBT is typically highly~     standardized and involves patients reviewing weekly lessons over the Internet. Patients also~     receive brief weekly support from a therapist via secure emails or phone calls. Past research~     shows that ~75% of patients complete ICBT and report large symptom improvements. Although~     these results are very promising, research also suggests that ICBT could potentially be~     improved by being more personalized in terms of amount of therapist contact, especially for~     clients with more severe symptoms. The current trial will involve therapists who work in a~     clinic that specializes in ICBT. Over one year, 440 patients with depression and/or anxiety~     will be randomized to either receive standardized (5 lessons completed in 8 weeks; once week~     therapist contact) or personalized ICBT (5 lessons completed in 8 weeks; personalized~     therapist contact depending on needs of patient). Psychosocial outcomes of patients in the~     two treatment arms will be compared post-treatment and at 3-month, 6-month, and 1-year~     follow-up from enrollment. Data on intervention usage, satisfaction measures, and costs will~     also be assessed.~   "
20061|NCT03304379|"~     The primary objective of the study is to evaluate the efficacy of fasinumab compared to~     placebo, when administered for up to 24 weeks in patients with osteoarthritis (OA) of the~     knee or hip.~      The secondary objectives of the study are: to evaluate the efficacy of fasinumab compared to~     non-steroidal anti-inflammatory drugs (NSAID)s, when administered for up to 24 weeks in~     patients with OA of the knee or hip; to assess the safety and tolerability of fasinumab~     compared to placebo and compared to NSAIDs, when administered for up to 24 weeks in patients~     with OA of the knee or hip~   "
20062|NCT03304366|"~     Aim of this study is to assess the corneal changes before and after pterygium excision by~     using pentacam system.~   "
20063|NCT03304353|"~     The purpose of this trial is to investigate whether a self-managed resistance training~     protocol is more effective than a predetermined resistance training protocol in improving the~     Foot Health Status Questionnaire pain domain score in individuals with plantar fasciopathy~     after a 12-week intervention.~   "
20064|NCT03304340|"~     The purpose of this study was to examine the outcomes of postural stability, activities of~     daily living function, and motor capacity of persons after stroke who received transcutaneous~     electrical nerves stimulation (TENS) or functional electrical stimulation (FES), in addition~     to SR, in the post-stroke acute phase. Such persons were compared with others who received SR~     alone in order to determine if the addition of TENS or FES resulted in earlier or more~     effective recovery.~   "
20065|NCT03304327|"~     The purpose of this study is to establish the tolerability of mindfulness and yoga therapy in~     the post-concussion period.~   "
20066|NCT03304314|"~     PTC(Pseudotumor cerebri) patients may develop increased Intracranial pressure (ICP) that can~     produces increased pressure around the distal optic nerve,which is likely followed by venule~     compression, ischemia, and loss of visual function.Vision loss in PTC is most commonly~     characterized by standard automated perimetry to measure peripheral visual field sensitivity.~      Pupillometry is a promising approach for functional assessment in PTC because it is~     noninvasive, objective, performed quickly with minimal patient cooperation needed.~      The feasibility of using chromatic multifocal pupillometry for assesment of PTC will be~     examined.~   "
20067|NCT03304301|"~     Background: The transition to long-term care facility can be a stressful and emotional event~     for the elderly. The evidences showed that the prevalence of depression and the cognition~     impairment were higher in the institutionalized elderly than the community dwelling elderly.~     It could affect the quality of life of the elderly and increase risk of mortality.~      Purpose: The aim of the study is to evaluate the effect of outdoor activities and sunlight~     exposure on depression, cognitive function, and quality of life among institutionalized~     elderly.~      Method: The design is a randomized control trial. Participants will be randomly allocated to~     experimental or control groups by block randomization. In the experimental group,~     participants will be encouraged to reduce time spent on bed and bedroom. Nurses, nurse aids~     or family will take participants outdoors and exposure their face, hands or arm to sunlight~     for 15-30 minutes a day, five days a week for three months (if the UV index is over 8~     according to the forecast of Center Weather Bureau, the participants will be asked to stay~     inside). In the control group, the participants will receive routine care. The control group~     will neither be encouraged to stay outdoors nor limit the chance to exposure to sunlight.~      Expected outcome: The expected benefit of the research is to improve the depression,~     cognitive function, and quality of life of the institutionalized elderly.~   "
20068|NCT03304288|"~     Randomized, open-label, multicentre study to assess the efficacy and safety of the~     combination of low-dose rituximab and ATRA in patients with steroid-resistant/relapsed ITP.~   "
20069|NCT03304275|"~     Randomized controlled trial of 2 strategies to provide adults with the Tdap vaccine to~     patients presenting to the emergency department. Rates of vaccination as well as effects on~     department efficiency will be measured.~   "
20070|NCT03304262|"~     The overall objective is to validate the methodology of a metaplasticity experimental design~     by assessing change in motor excitability after administration of priming transcranial direct~     current stimulation (tDCS) followed by repetitive transcranial magnetic stimulation (rTMS) in~     healthy human participants.~   "
20071|NCT03304249|"~     The purpose of this study is to learn if providing a family-based group program using mobile~     health technology (iAmHealthy Healthy Lifestyles Program) is effective at improving child~     weight, nutrition, and physical activity.~   "
20072|NCT03304236|"~     This study aims to quantify the clumsiness and decreased dexterity seen in the grip and~     release test using a simple glove with sensors that can quantify the abnormal motion of this~     classical sign. This new tool will give a mechanistic insight into the myelopathy. The~     findings of this study will also form the basis of a prospective longitudinal study with~     clinical and radiological evaluation to compare the prognosticating value of this new~     information in clinical practice.~   "
20074|NCT03304210|"~     The PIPAC nab-pac study is designed to examine the maximal tolerated dose of albumin bound~     nanoparticle paclitaxel (nab-pac, Abraxane) administered with repeated pressurized~     intraperitoneal aerosol chemotherapy (PIPAC), in a multicentre, multinational phase I trial.~   "
20078|NCT03304158|"~     Type 2 diabetes is the largest growing concern across the globe, and this is particularly~     apparent in developing countries, including Nepal. Despite the growing burden and chronic~     nature of diabetes, prevention and control of this disease is far from adequate setting in~     Nepal. Moreover, there is lack of evidence on effectiveness and affordability of a population~     approach on reducing blood glucose level among diabetes persons. The main aim of this study~     is to determine the effect of Female Community Health Volunteers' (FCHVs)-led family-based~     health education and screening on blood sugar level in adults at community level in Nepal.~     This is a community-based cluster randomized controlled trial involving family based health~     education through FCHVs in Nepal. People ≥25 years of age listed in the Community-Based~     Management of Hypertension (COBIN) study and who were diabetics are eligible for eligible for~     participation in the study. FCHVs will conduct family based health education and fasting~     blood glucose measurements in the treatment arm vs not any interventions in the control arm.~     Independent assessors will conduct the baseline and end line assessment of the intervention.~     Intention to treat analysis and per protocol analysis will be used in analysis to detect~     significant differences between treatment and control group participants at baseline and~     follow up. For individual outcomes, proportions will be compared using Chi-square test and~     continuous measures will be compared using t-tests. Random effect mixed regression analysis~     will be adjusted for age and sex. Since randomisation will be at the cluster level in the~     study, a random-effect model will be used to account for clustering effect. Effectiveness of~     the intervention will be tested by analysis of covariance, which will allow us to adjust for~     baseline differences between groups. It is anticipated that the study can give valuable~     information regarding effectiveness, acceptability, and feasibility of an innovative way to~     improve diabetes management. Assessing the FCHVs' ability to address diabetes may contribute~     to develop a policy that can be scaled-up to a national level.~   "
20079|NCT03304145|"~     The goal of this project is to evaluate the effectiveness of shared-decision-making (SDM) to~     manage chronic and breakthrough pain in patients with metastatic breast cancer (MBC), lung~     cancer (LC), and other advanced cancers (AC). Providers will receive evidence-based education~     on shared decision-making strategies and comprehensive pain management at study start up. In~     addition, the information will be available on the Carevive platform for reference at the~     point of care. This multisite study will enroll 105 MBC, LC, or AC patients from three cancer~     institutions. This project will explore the SDM model using a touchscreen-based expanded pain~     assessment (EPA) to evaluate the impact of the shared-decision-making model on pain~     management, and explore its relationship to pain management care planning in patients with~     MBC, LC, or AC. Patients with MBC, LC, or AC experiencing pain will use the Carevive Systems~     software in the clinic to answer questions regarding decision making preferences and complete~     a comprehensive assessment of their pain status. Treatment recommendations and a care plan~     will be provided to the patient at the time of the visit. At each clinic visit over 4 months,~     the patient will again complete the pain assessment and receive appropriate treatment~     recommendations and a revised care plan.~   "
20080|NCT03304132|"~     The human oral cavity is a diverse habitat that contains approximately 700 prokaryotic~     species. The oral microbiome is comprised of 44% named species, 12% isolates representing~     unnamed species, and 44% phylotypes known only from 16S rRNA based cloning studies~     (http://www.homd.org/). Species from 11 phyla have been identified: Firmicutes,~     Bacteroidetes, Proteobacteria, Actinobacteria, Spirochaetes, Fusobacteria, TM7,~     Synergistetes, Chlamydiae, Chloroflexi and SR1 (http://www.homd.org/). Because these~     observations have been mainly based on data generated from traditional Sanger sequencing, the~     diversity of oral microbiome is highly likely underestimated. Application of high throughput~     sequencing to the oral microbiome similar to the scale of the microbiome studies of other~     body sites (GI tract, skin, and vagina) under the Human Microbiome Project is necessary to~     obtain data essential for understanding the diversity and community structure of the oral~     microbiome in health and disease.~   "
20081|NCT03304119|"~     Patellar instability (recurrent patellar dislocation) can occur at any age. It is most often~     seen in young subjects, especially among adolescents. It is commonly accompanied by~     anatomical factors. A new factor not described in bibliographic sources and characterized by~     an external toggle of the tibial tuberosity is frequently found in patients with patellar~     instability thanks to MRIs. This does not seem to be the case when there is no patellar~     pathology. A statistical study is needed to assess this rotary anomaly. Validate the~     predictive benefits when measuring the torsion of tibial tuberosity in cases with recurrent~     patellar dislocation.~   "
20082|NCT03304106|"~     Use of Artificial Intelligent (AI) technology to assist audiologists in programming cochlear~     implants.~   "
20083|NCT03304093|"~     Two Phase III trials showed superiority in terms of efficacy and tolerance of nivolumab in~     second-line treatment compared to docetaxel in metastatic NSCLC in the general population, so~     it is important to evaluate this treatment in PLWHIV (Patient Living With HIV) in maximum~     security conditions, taking into account their specificities and complex underlying~     immunological status. As NSCLC in PLWHIV is a rare tumour, a phase 2 trial, using DCR~     (Disease Control Rate) data, would be able to recruit a sufficient number of patients, in a~     reasonable period of time, to provide a proof of concept of the safety and efficacy of~     nivolumab in this population. Therefore, we think that an open-label, one arm phase 2 trial,~     with a rapid accrual, would be currently a crucial approach and a window of opportunity to~     explore whether nivolumab could find its place in PLWHIV with NSCLC. Such a trial is~     typically a trial for an academic sponsor, experienced in PLWHIV with NSCLC, which previously~     showed its ability to recruit patients with such a rare disease as the IFCT did with the~     IFCT-1001 CHIVA trial, testing carboplatin plus pemetrexed followed by pemetrexed.~   "
20084|NCT03304080|"~     This is a multicenter, phase I/II trial of anastrozole, palbociclib, trastuzumab, and~     pertuzumab is proposed as first-line therapy in metastatic hormone receptor-positive,~     HER2-positive breast cancer patients. In this phase I/II clinical trial, the researchers aim~     to establish the safety and efficacy of dual HER2 therapy in combination with palbociclib and~     anastrozole, which represents a novel and all biologic approach to the treatment of HR+,~     HER2+ metastatic breast cancer. Additionally, the researchers aim to examine potential~     biomarkers of response to palbociclib including cyclin D1 expression levels, phosphorylated~     retinoblastoma expression and p16 levels. The researchers intend to use RNA sequencing to~     assess for other predictors of response in an unbiased manner to see if this correlates with~     inhibition of Ki-67 and phosphorylated retinoblastoma expression as well as evaluate for~     potential mechanisms of resistance.~   "
20085|NCT03304067|"~     The Digital Health Tool for Parental Management of Childhood Asthma -- Impact on Asthma~     Control Test Scores Study is a 16 week, prospective, intent-to-treat, 2-arm randomized~     controlled trial that aims to evaluate the impact of the Tueo Health program on asthma~     control as indicated by change in baseline and study end (week 16) score on the Childhood~     Asthma Control Test score (ages 6- under 12 years) and the Asthma Control Test (ages 12-17~     years) in children with uncontrolled asthma as the primary study objective.~   "
20088|NCT03304028|"~     Early detection of pulmonary exacerbations (PEx) in Cystic Fibrosis (CF) patients is~     important to quickly trigger treatment and reduce respiratory damage. The investigators~     hypothesize that using home-based connected devices (CDs) in educated patients applying~     Cumulative sum charts (CUSUM) to monitor physiological parameters (PP) and patients'~     perception reported (PRP), will allow early detection of PEx.~      Objective: to study clinical validity of using CDs and evaluate adherence and satisfaction in~     CF patients and teams~      Design: 3 phase multicenter study in 36 CF patients aged >=12 years. Phase 1, patients are~     equipped during 3 months with CDs. PP and PRP to estimate CUSUM parameters are collected. In~     phase 2, patient's personalized educational plan to manage alerts is built. In phase 3, PP~     and PRP are collected during 12 months. Clinical validity, change in patients clinical data,~     quality of Life/Anxiety-Depression/Satisfaction, patients and teams' acceptance and adherence~     are assessed.~   "
20089|NCT03304015|"~     This study evaluates whether a factory wide intervention, HERrespect, can reduce female~     garment workers' experiences of intimate partner violence, and experience and/or witnessing~     of violence in the workplace. This is a quasi-experimental study involving four intervention~     and four control factories.~   "
20090|NCT03304002|"~     Routine incorporation of decision aids into oncology practice has the potential to~     significantly improve patients' experiences with cancer by increasing the likelihood that~     they make informed treatment decisions aligned with their values. Unfortunately, only a~     minority of the more than 1.6 million patients diagnosed annually with cancer ever receive~     one due to limited clinic resources for administration and challenges in timely~     identification of appropriate patients. Online delivery directly to patients addresses some~     of these barriers but is insufficient on its own to ensure accessibility for patients at the~     time they most benefit from support.19 It is critical that active, multi-faceted~     implementation strategies that target barriers to the widespread use of web-based decision~     aids be identified, as these tools have the potential to significantly improve the quality of~     oncologic care.~      Based on strong preliminary work, the investigators have developed and piloted a package of~     implementation strategies that effectively overcomes barriers to delivery of a web-based~     breast cancer surgery decision aid in an academic and community clinic. Although the strategy~     was successful, patients were white and educated; further investigation is imperative in~     settings that provide care to underserved patients to ensure the intervention will mitigate,~     rather than worsen, existing disparities in breast cancer care. This is especially critical~     given that underserved patients may benefit most from shared decision-making interventions~     such as the one described. To study this, the investigators propose a pilot study within a~     clinic that serves a catchment area with a high proportion of African American, rural and low~     income patients. The investigators will iteratively assess and enhance our implementation~     package using concepts outlined in the Knowledge-to-Action Cycle, which emphasizes local~     context in balancing fidelity and flexibility. The specific aims are: 1) To identify patient~     and clinic level barriers to implementation of a web-based breast cancer surgery decision aid~     in a clinic that cares for underserved patients, and 2) To test and expand our current~     implementation package's ability to address barriers in a clinic that cares for underserved~     patients. The investigators will determine the reach of implementation and acceptability of~     this method of decision aid delivery to stakeholders.~   "
20091|NCT03303989|"~     Pegloticase treatment for chronic refractory gout is limited by immunogenicity. The~     investigators propose the REduCing Immunogenicity to PegloticasE (RECIPE) trial to begin to~     investigate the question of whether a short course of immune modulating therapy with~     myclophenolate moefitil can significantly and safely attenuate immunogenicity to pegloticase~     and ensure patients afflicted with chronic refractory gout have better treatment outcomes and~     improved quality of life.~   "
20092|NCT03303976|"~     To obtain first-in-human data on a new candidate vaccine against Streptococcus pneumoniae in~     healthy adult and elderly volunteers.~      The study aims to assess the safety and immunogenicity of a bioconjugate investigational~     vaccine compared to the control group (Pneumovax23).~   "
20093|NCT03303963|"~     Recent advances in molecular diagnostics of tuberculosis, especially the GeneXpert~     Mycobacterium tuberculosis/Rifampicin test have reduced the time to diagnose Rifampicin~     Resistant Tuberculosis (RR-TB) but only rifampicin resistance is diagnosed, leading to~     presumptive diagnosis of resistance to isoniazid and maybe other drugs. Thus in low and~     middle income countries, most drug sensitivity testing relies on phenotypic drug resistance~     testing, which takes up to 4 months. In addition, currently, culture on monthly sputum~     samples is recommended by the World Health Organization for follow-up of Rifampicin Resistant~     Tuberculosis patients under treatment. Unfortunately, culture is often not locally available~     and samples need to be transported from field to culture laboratories. The associated~     transport delays lead to high rates of contamination and false negative culture, particularly~     in laboratories in low resource settings. Many gaps for the diagnosis and management of RR-TB~     patients still need to be addressed and the DIAMA project (DIAgnostics for Multidrug~     resistant tuberculosis in Africa) study aims to address some of them.~   "
20094|NCT03303950|"~     This phase II trial studies how well busulfan, fludarabine, donor stem cell transplant, and~     cyclophosphamide in treating patients with multiple myeloma or myelofibrosis. Drugs used in~     chemotherapy, such as busulfan, fludarabine, and cyclophosphamide, work in different ways to~     stop the growth of cancer cells, either by killing the cells, by stopping them from dividing,~     or by stopping them from spreading. Giving chemotherapy before a donor stem cell transplant~     helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem~     cells) and cancer cells. When the healthy stem cells from a donor are infused into the~     patient they may help the patient's bone marrow make stem cells, red blood cells, white blood~     cells, and platelets. Giving busulfan and fludarabine before and cyclophosphamide after donor~     stem cell may work better in treating patients with multiple myeloma or myelofibrosis.~   "
20095|NCT03303937|"~     Prospective, multicenter observational study to collect Escherichia coli (E. coli) isolates~     originating from mechanically ventilated intensive care unit (ICU) patients; in order to~     characterize phenotype and genotype of E. coli strains retrieved from the lower respiratory~     tract of ventilated patients.~   "
20096|NCT03303924|"~     This is a Phase 1, multiple dose, open-label pharmacokinetic study conducted in healthy adult~     male and female subjects to determine and compare plasma, epithelial lining fluid (ELF) and~     alveolar macrophage (AM) concentrations of ETX2514 and sulbactam in healthy adult subjects~     after intravenous infusion of ETX2514 1.0 g given concurrently with intravenous sulbactam 1.0~     g, administered every 6 hours with each infused over 3 hours, for 3 consecutive doses~   "
20097|NCT03303911|"~     This is an open-label, randomised, multi-dose study to evaluate the PK profile and PD effect~     of cytisine when administered at doses of 1.5 mg and 3.0 mg following the commercialised~     25-day schedule.~   "
20167|NCT03302988|"~     The aim of this study is to determine whether wound edge eversion, achieved by careful~     placement of dermal sutures, improves the cosmetic outcome of operative wounds closed on the~     head or neck.~   "
20426|NCT03299608|"~     To quantify the diagnostic, prognostic and therapeutic value of spectrometric analysis of~     exhaled breath from hematological patients with respiratory infection.~   "
20098|NCT03303898|"~     Leishmaniasis is considered by the WHO as emerging and uncontrolled diseases. They are the~     second leading cause of death and the fourth leading cause of morbidity in tropical diseases.~     Leishmaniasis is parasitic reticulo-endotheliosis, the pathogenic agent of which is a~     flagellated protozoan belonging to the genus Leishmania. It is estimated that there are about~     2 million new cases per year. Effective treatments against visceral leishmaniasis are few and~     resistance problems appear. To date, only a canine vaccine is available protecting dogs from~     the development of canine leishmaniasis to L. infantum. In man, in parallel clinical cases,~     leishmaniasis is characterized by a large number of asymptomatic carriers. This is the case~     in the Alpes-Maritimes where 50% of the inhabitants of the hinterland of Nice are carriers of~     the parasite.~      the investigators wish to study the protective immune response to the parasite and more~     particularly to the asymptomatic carriers. Indeed, these patients were infected with the~     parasite and did not develop the disease. Understanding the protective immune response in~     these patients against the parasite is therefore paramount in the development of a human~     leishmaniasis vaccine.~      For this purpose, the investigator wants to make an ex vivo study of the immune response of~     lymphocytes coming from asymptomatic carriers after stimulation by Leishmania vaccine~     peptides. It also wants to describe the immune response, after stimulation by these peptides,~     in the lymphocytes of subjects asymptomatic carriers and lymphocytes from subjects not~     infected with the parasite and comparing them. This study is unicentric and non-randomized.~     It wishes to recruit 20 asymptomatic carriers of L. Infantum and 10 uninfected subjects. They~     will be selected from our database. A simple blood sample will be taken. After verification~     by quantitative PCR and western blotting of their status towards leishmaniasis, the team will~     divide them into two groups (asymptomatic or healthy). Then the blood samples will be sent to~     the team of Jean Loup Lemesre of the Laboratory INTERTRYP - UMR177 of the IRD in Montpellier.~     ELISPOT analysis and assay of cytokines and proteases to describe the immune response of the~     two groups and to compare them. In addition, cell typing will be performed by flow cytometry~     to determine the type of lymphocytes involved in the immune response against Leishmania~     peptides. HLA typing will also be performed to validate the HLA coverage of the peptides~     tested. Finally, an analysis of the transcryptome will be carried out, which will allow to~     identify the differential expression of genes and metabolic pathways involved in the immune~     response and thus to understand how asymptomatic people can control the infection.~   "
20099|NCT03303885|"~     Liposarcomas are the most common type of soft tissue sarcomas (STS). Among liposarcomas,~     well-differentiated liposarcoma (WDLPS)/dedifferentiated liposarcoma (DDLPS) are the most~     frequent types. WDLPS are composed mostly of mature fat whereas DDLPS contain both a WDLPS~     component and a non-lipomatous sarcoma component mostly of high grade. More than 50% of DDLPS~     will relapse locally. A significant proportion of patients will remain with a non-resectable~     disease that will metastasize in 20% of cases. Standard chemotherapy is poorly efficient and~     alternative options are so far limited. Identification of new therapeutic targets is urgent~     and mandatory. the recent preliminary results as well as data from the literature led us to~     hypothesize that the FGF (Fibroblast Growth factor)/FGFR pathway is involved in~     liposarcomagenesis and might therefore be a novel relevant therapeutic target in WDLPS/DDLPS.~      Description of the project The project associates 4 teams with a longstanding collaboration :~     3 teams fom Nice (Nice University Hospital/IRCAN, Nice University Hospital, Comprehensive~     Cancer Center Centre Antoine Lacassagne and one team from Bordeaux (Comprehensive Cancer~     Center Institut Bergonié). These 4 teams are experts in the clinics, pathology and molecular~     genetics of sarcomas as well as in biostatistics.~        1. Expression studies on the role of the syndecan-1 (SDC1)/FGFR pathway in WDLPS/DDLPS~          tumorigenesis~           The recent studies provide original results that may have a direct application in~          treatments of liposarcomas. They suggest that SDC1 -an effector of the FGF/FGFR pathway-~          might be involved in DDLPS tumorigenesis. Staff will analyse:~             -  The pattern of expression and localisation of syndecans, FGFs and FGFRs in~               WDLPS/DDLPS both in a large collection of 249 primary tumors and in our in-house~               panel of high quality and validated human WDLPS/DDLPS cell lines.~             -  The prognostic value of SDC1, FGF2 and FGF18 expression by correlation to the~               patient clinical outcomes~        2. Fonctional studies of the role of the SDC1/FGFR pathway in WDLPS/DDLPS tumorigenesis. We~          will analyse:~             -  The effects of modulating SDC1, FGFR expression in WDLPS and DDLPS cells on cell~               proliferation, cell cycle, apoptosis and on their capacity to differentiate in~               adipocytes.~             -  The sensitivity of WDLPS and DDLPS cells to the FGFR inhibitor JNJ-427556493 as a~               single agent or in combination with other antagonists.~             -  The mechanisms of sensitivity and resistance to JNJ-427556493 by phosphoproteomic~               analysis of WDLPS and DDLPS cells before and after JNJ-427556493 treatment.~             -  The involvement of SDC1 in the dedifferentiation process of liposarcoma. Expected~               results staff expect to demonstrate the relevance of the SDC1/FGFR pathway in~               liposarcomas. We also expect to link drug activity to genomics and proteomics data.~               This will allow the characterization of the activity of FGFR inhibitors and the~               identification of powerful preclinical biomarkers of drug activity and mechanisms~               of resistance in DDLPS. The availability of xenograft models will allow us to~               validate our in vitro findings in the in vivo setting with the ultimate goal to~               improve patient management.~      The availability of an early clinical trial unit in Institut Bergonié, managed by A.~     Italiano, will give the immediate opportunity to transfer our data to the management of~     metastatic liposarcoma patients.~   "
20100|NCT03303872|"~     This study is prospective Cohort study which was performed in multicenter (General Hospital)~     in Korea. Inclusion criteria is patients post pacemaker implantation. The purpose is to~     investigate the occurrence of device detected subclinical atrial fibrillation (atrial high~     rate episode) in patients post pacemaker implantation and assess long term clinical results.~   "
20101|NCT03303859|"~     Preterm delivery is a public health priority in Martinique, a French oversees territory~     located in the Caribbean, with a rate of 10,5% substantially higher than in Continental~     France (7,5%). Bacterial vaginosis is an imbalance of vaginal flora known to be associated~     with preterm delivery risk. Studies driven in the United States have pointed out that 50% of~     the excess in preterm birth rate observed in Afro-American population compared to Caucasian~     population may be attributable to infection. Bacterial vaginosis appears much more prevalent~     in our population than in Continental France (approximatively 30% versus 7%) and may~     constitute an explanation to the discrepancy in preterm delivery rate.~   "
20102|NCT03303846|"~     This clinical trial studies normal breast tissue changes combined with breast magnetic~     resonance imaging (MRI) that may suggest the beginnings of cancer development. Using breast~     tissue markers in combination with breast imaging such as MRI may help to more accurately~     assess a woman's risk of developing breast cancer.~   "
20103|NCT03303833|"~     The GEOLynch cohort study has been established to investigate the influence of genetic,~     environmental and other factors on tumour risk in persons with Lynch syndrome.~   "
20104|NCT03303820|"~     Many clinical trials show that 30 to 50 % of the hospitalized patients are undernourished in~     various degrees. This prevalence didn't change since 15-20 years The fact is that the present~     undernutrition in the admission deteriorates during the hospitalization.~      Besides, the cerebral vascular accident (AVC) complicates the first days, in at least 50 % of~     the cases, the disorders of the gulp, which are a risk factor of acquired undernutrition. The~     nutrition holds an important place in the therapeutic coverage of the AVC. Nevertheless, the~     link between the undernutrition the entrance and the evolution of the AVC is at the moment~     only little known. The purpose is to study the impact of the undernutrition in the entrance~     to the hospital (undernutrition previous to the AVC), on the gravity and the evolution~   "
20105|NCT03303807|"~     Pulmonary vascular dysfunction (DVP) is associated with a pejorative prognosis during ARDS.~     There is no specific therapeutic intervention to thwart it. Extracorporeal CO2 purification~     (ECCO2-R) is a technique that has been very rapidly diffused and adopted in intensive care~     since commercialization of the devices but, the formal clinical evaluation is insufficient.~     It could significantly improve the prognosis of patients with both DVP and refractory~     hypercapnia.~   "
20106|NCT03303794|"~     Total knee and hip replacements are some of the most common orthopedic procedures that~     require aggressive postoperative pain management. This management helps us to improve~     clinical outcomes such as participation in early physical therapy, hospital discharge, and~     patient satisfaction. Based on the recent anatomical evidence and the investigator's~     knowledge of the complexity of the knee joint innervation the investigator proposes a new~     regional anesthesia technique that provides a complete sensory blockade and better analgesia~     while preserving the quadriceps strength and avoiding the potential for foot drop caused by~     inadvertent blockade of the common peroneal nerve.~   "
20107|NCT03303781|"~     Background: Cardiac rehabilitation is indicated for ischemic heart disease patients; the~     program content of which is well described in both European and American guidelines. In~     contrast, literature on cardiac rehabilitation program content and efficacy in the Asian~     population is sparse.~      Methods: BeSingCardioRehab will be an intercontinental, retrospective cohort study conducted~     in two cardiac rehabilitation referral centers in Belgium and Singapore. The first aim is to~     compare the impact of phase II center-based cardiac rehabilitation on Major Adverse Cardiac~     Events for ischemic heart disease patients between Europe (i.e. Belgian) and Asia (i.e.~     Singaporean) in the long-term. The second objective is to compare the efficacy of phase II~     cardiac rehabilitation on short-term morbidity (assessed with the validated SMART Risk Score)~     between index European and Asian ischemic heart disease patients. The level of compliance of~     the Belgian and Singaporean cardiac rehabilitation programs to European guidelines standards~     will also be evaluated.~      Hypotheses BeSingCardiorehab will be one of the first studies assessing cardiac~     rehabilitation in Asia. Based on the BeSingCardioRehab study results, phase II center-based~     cardiac rehabilitation programs, can/will be adapted in order to improve program content and~     outcomes.~   "
20108|NCT03303768|"~     Prenatal diagnosis of coarctation is difficult because the ductus arteriosus masks the~     isthmus narrowing. The problem lies in the fact that it is difficult to assert in utero~     diagnosis and to predict severity of neonatal symptomatology. However, it is essential to try~     to establish the diagnosis since it has been shown that the prenatal diagnosis improves~     survival and reduces morbidity.~   "
20109|NCT03303755|"~     Cerebral palsy (CP) is the most frequent disability in children, and despite advances in~     perinatal medicine, its incidence has not declined worldwide. The vast majority of these~     patients are malnourished. As the severity of the PC increases, nutritional disorders~     increase the health risk of patients are more common and prominent. In this population, there~     are practical difficulties to perform a nutritional and growth assessment which makes it~     difficult to treat and follow up, because of the lack of reference growth in Argentina, and~     the difficulty in taking anthropometric measurements of weight and height because of their~     motor compromise, posture and muscle tone.~      The main objective is to design and validate predictive models for the nutritional and growth~     assessment of children and adolescents with CP and instruments for estimating weight and~     height from body segments, in order to improve care, quality of life of these patients to~     promote their social inclusion.~      Material and method: It will be an observational, descriptive and cross-sectional study.~     There will be two parts of the study, in the first part the population will be healthy~     children from 2 to 18 years old from Cordoba, Argentina. The sample size was calculated based~     on growth WHO standards data, for α=0.05 and 1-β=0.80, creating an stratified sampling~     divided in 16 age groups for each age. This first part will help to establish which body~     segments to use.~      In the second part, the population will be children and adolescents from 2 to 18 years old~     with diagnosis of CP from Córdoba, Argentina. A stratified sequential sampling shall be~     performed. The sample size will be 192 patients, 12 per age stratum. The variables studied~     will be: weight, height, body segments, sex, age, CP type, feeding path and type of feeding.~      For the analysis of the data the normal continuous variables will be described in means with~     their respective standard deviations and those of non-normal distribution in medians with~     their ranges. For the development of the predictive equations using body segments measures, a~     generalizable linear regression model will be used. The correlation coefficient r,~     determination R2 and test of F will be calculated with p <0.05. To generate predictive growth~     models, the percentiles from 3 to 97 will be calculated, using the LMS method and a q-q~     graph.~      The study of nutrition in patients with PC is an emerging field, for which this work plan~     seeks to develop methodologies that promote social inclusion by making substantial and~     necessary contributions to improve the treatment of this pathology.~   "
20110|NCT03303742|"~     Evaluation of patient satisfaction, color difference, marginal integrity and survival of~     Bruxzir Zirconia complete coverage crowns with feather edge versus deep chamfer finish line~     marginal design.~      (Randomised Controlled Trial)~   "
20111|NCT03303729|"~     10 young males will be recruited to participate in a randomized double blinded crossover~     study to investigate the influence of concomitant intake of two different types of~     carbohydrate with protein hydrolysate on the absorption kinetics of protein-derived amino~     acids and the impact on myofibrillar protein synthesis. During the trial days the subjects~     will perform a bout of whole body resistance exercise and ingest a supplement of meat~     hydrolysate labeled with D5-phenylalanine together with randomized and double blinded type of~     carbohydrate consisting of either glucose or cluster dextrin.~      The primary outcome is the time to obtain peak concentration of D5-phenylalanine after intake~     of meat hydrolysate with either glucose or cluster dextrin.~      Hypotheses:~      I) The cluster dextrin will increase the absorption of the amino acids from the meat~     hydrolysate, and thereby result in a faster rise and a higher peak in plasma amino acid~     concentration in the postprandial period.~      II) The meat hydrolysate will increase the protein synthesis rate to a higher extent when~     combined with cluster dextrin than with glucose.~   "
20112|NCT03303716|"~     A registry focused on the natural history, management and treatment of patients with~     Bohring-Opitz Syndrome (ASXL1), Shashi-Pena Syndrome(ASXL2) and Bainbridge-Ropers Syndrome~     (ASXL3).~   "
20113|NCT03303703|"~     Patients who have just experienced a first major cardiac event are at risk of experiencing~     heightened negative emotions, which further negatively impact self-management of health~     behaviors. For those patients in phase II cardiac rehabilitation, there is an opportunity to~     address physical and emotional wellbeing to optimize self-management of diet and exercise.~     This study will pilot test an intervention aimed at improving these patients' abilities to~     regulate their emotions as a mechanism to minimize psychological distress and improve~     self-management of diet and exercise, as well as improve quality of life. This innovative~     pilot will generate knowledge about the impact of emotion regulation in first event cardiac~     rehabilitation patients.~   "
20114|NCT03303690|"~     By means of the Ankle Spacer patients will be implanted, the clinical and radiological~     results of which will be prospectively recorded and analyzed at different points in time.~   "
20115|NCT03303677|"~     The goal of the study is to compare postoperative symptom scores and endoscopy findings~     between in patients who receive either nasal saline rinses, saline + budesonide, and saline +~     topical antibiotics and budesonide following endoscopic sinus surgery.~   "
20116|NCT03303664|"~     The goal of the proposed study is to develop and implement a comprehensive strategy to~     address pain management in the inpatient setting while appropriately managing pain and~     optimizing patient safety in the inpatient setting. This strategy involves developing a new~     health Information Technology tool in the Omnicell and electronic medical record,~     implementing a menu of pain management and relaxation strategies, and developing~     educational materials for staff and patients to change the culture of pain management.~   "
20117|NCT03303651|"~     This prospective randomized clinical trial evaluates the effects of a monitor-guided opioid~     analgesia during general anesthesia. To date no standard-monitoring device exists to~     specifically reflect the analgesic component of general anesthesia. Quality and safety of~     general anesthesia are of major clinical importance and should be improved by limiting the~     opioid analgesic's dosage to the minimum amount needed. The study compares the effects of~     monitoring nociception during general anesthesia with different innovative techniques in~     comparison to routine clinical practice.~   "
20118|NCT03303638|"~     Behavioral and psychological symptoms of dementia (BPSD) greatly impact quality of life (QoL)~     for people with dementia, and pharmacological interventions are costly, ineffective or~     life-threatening. Law-makers support non-pharmacological interventions like multi-sensory~     environments (MSE) but they have not been widely studied. There is a critical need for~     investigation of MSE, particularly during assisted bathing, showering, and/or tub bathing,~     where most BPSD occur.~   "
20119|NCT03303625|"~     The purpose of this study is to assess the safety and tolerability of an intramuscular~     regimen of two doses (1*10^11 viral particles [vp]) of an investigational respiratory~     syncytial virus (RSV) vaccine candidate (adenovirus serotype 26 respiratory syncytial virus~     pre-fusion conformation stabilized F protein [pre-F] [Ad26.RSV.preF]) in adults aged 18 to 50~     years and RSV-seropositive toddlers aged 12 to 24 months.~   "
20120|NCT03303612|"~     The primary hypothesis of the proposed study is that an electrophysiology-based algorithmic~     approach is superior to standard clinical follow-up with remote monitoring in reducing the~     combined endpoint of cardiovascular hospitalization, syncope and death in patients with new~     onset conduction disturbance following transcatheter aortic valve implantation (TAVI).~   "
26905|NCT03214809|"~     Study to assess the possible effects of the use of a point-of-care thoracic ultrasound~     protocol for hospital medical emergency teams (MET)~   "
20122|NCT03303586|"~     Nocturnal worsening of asthma is common. It is characterized by overnight exacerbation of~     asthma symptoms such as shortness of breath, chest tightness, coughing, and wheezing,~     increased need of asthma medications and airway hyperresponsiveness, and decline in lung~     function (1). Nocturnal asthma has been attributed in part to circadian variations in lung~     function and airway inflammation. However, other factors including sleep, supine posture and~     lung volume may also contribute to nocturnal asthma. Current treatments often improve~     nighttime asthma symptoms. Nevertheless, nocturnal asthma is still common. Up to 2/3rd of~     asthma patients report nocturnal asthma symptoms, and many asthma related events occur at~     night, indicating poor asthma control. Results from an ongoing study suggest that in asthma~     while subjects were supine, fluid shifted out of the legs and accumulated in the thorax~     (rostral fluid shift) contributing to lower airway narrowing in asthma. A previou study has~     shown that wearing compression stockings during the day reduces fluid retention in the legs,~     reduces nocturnal rostral fluid shift out of the legs, and improves sleep apnea (2, 3). The~     aims of the proposed study is investigate whether off-the-shelf, below the knee compression~     stockings will attenuate nocturnal fluid shift and lower airway narrowing in asthma.~   "
20123|NCT03303573|"~     This study is a retrospective review on the safety and efficacy of repetitive erythropoietin~     injection in children with cerebral palsy~   "
20124|NCT03303547|"~     Predicting prognosis in rectal cancer and determining indications for neoadjuvant treatment~     is an ongoing challenge for colorectal multidisciplinary teams (MDTs). Staging is almost~     universally based on the TNM system which, despite multiple changes and increasing levels of~     sub-classification and complexity, is still flawed in its ability to stratify patients and~     predict prognosis(1-3). Determining which patients will benefit most from neoadjuvant and~     adjuvant therapy is still controversial; NICE guidelines are open to interpretation(4) and~     there is significant geographic variation in the way patients are managed. The Aim of this~     study is to prove the accuracy of MRI diagnosis of ENTD and its adverse effect on prognosis.~   "
20125|NCT03303534|"~     This research study will compare the impact of dietary restriction pre-operatively before~     carotid endarterectomy compared to the standard nutrition that a patient typically eats. The~     investigators want to find out how patients comply and generally how well patients do with~     this type of dietary restriction before their surgery since animal studies suggest that short~     - term dietary restriction may be beneficial before surgery.~   "
20126|NCT03303521|"~     The purpose of this study is to evaluate the efficacy of ZS in the treatment of hyperkalemia~     in patients on hemodialysis.~   "
20127|NCT03303508|"~     detection of anti-ds DNA in patients with rheumatic diseases by two methodes :~     immunofluorescence & ELISA~   "
20128|NCT03303495|"~     The primary purpose of this study is to determine the non-inferiority of overall survival~     FOLFIRI with or without Bevacizumab compared with Irinotecan (CPT-11) with or without~     Bevacizumab as Second-line therapy in Patient with Metastatic Colorectal Cancer.~   "
20129|NCT03303482|"~     Background. To increase school readiness, Pre-K programs for low-income children must be~     responsive to the role of trauma in the lives of children, families, and staff. In 2017-2018,~     the School District of Philadelphia's (SDP) Office of Early Childhood Education will help~     Pre-K teachers support children's social‐emotional and behavioral health, which is essential~     for early learning, by offering teachers a professional development course called Enhancing~     Trauma Awareness (ETA).~      Purpose. To determine whether teachers who take ETA will have: 1) better work functioning; 2)~     more trusting work relationships; and 3) better health.~      Population. Pre-K classroom teachers (n=128) working in centers under SDP auspice that serve~     exclusively low-income (≤300 % of poverty) children.~      Intervention. A 12-week professional development course—Enhancing Trauma Awareness—will~     delivered by Lakeside Global Institute in 6 group sessions, with 16 teachers per group and~     each session lasting 2.5 hours.~      Design. Consenting teachers will be randomly assigned by classroom (lead teacher and/or~     assistant teacher) to receive the ETA course in either fall 2017 (intervention groups) or~     spring 2018 (wait-list control groups).~      Data collection and analysis. An external evaluation team (Temple University) will administer~     a confidential, online survey to all 128 teachers in fall 2017 (before fall course), winter~     2017 (after fall course), and spring 2018 (after spring course). Teacher-children~     relationship quality will be the a priori primary outcome, and secondary outcomes will be~     assessed across the domains of work functioning, trust, and health.~   "
20130|NCT03303469|"~     [18F] FMISO PET to determine hypoxia in patients with HCC treated with TACE.~   "
20131|NCT03303456|"~     This project tests the feasibility of implementing a smartphone application - Ginger.io - in~     the UC Davis Early Psychosis Program, and investigates whether mobile health technology can~     improve treatment delivery and outcomes in individuals with early psychosis. Ginger.io is a~     smartphone application that utilizes methods of passive data collection (i.e. data gathered~     without active interaction/contribution from the user) to gather communication, movement, and~     interaction data from smartphone devices to model individuals' social, physical, and mental~     health. These models are used to infer health-related outcomes and could inform treatment. By~     implementing the Ginger.io application in the UC Davis Early Psychosis Program with an~     integrated clinical and research infrastructure, the investigators will be able to quickly~     determine its feasibility for use in early psychosis populations, while simultaneously~     developing its ability to systematically capture aspects of relapse and recovery that are~     unique to this patient population.~      Objectives: This project has three principle objectives related to early psychosis care: 1)~     improve treatment delivery, 2) improve patient outcomes, and 3) lower treatment costs. The~     project will target individuals in the early stages of psychotic illness, including~     individuals at high risk for developing a psychotic illness (termed clinical high risk or~     CHR) and individuals within three years of their first psychotic episode (termed first~     episode psychosis or FEP). The early stages of psychotic illness represent a critical period~     for intervention; early identification of clinical deterioration and subsequent targeted~     intervention is crucial for rapid remission of symptoms and reduced relapse rates. However,~     without the information necessary to identify patients in need of such intervention,~     providers are limited in their ability to respond rapidly. Within the UCD Early Psychosis~     Program, a mobile health application such as Ginger.io has the potential to equip the~     providers and caregivers with valuable insight into a patient's status in real-time without~     the burden of increased appointments and intrusive monitoring, allowing the identification of~     early psychosis patients most in need of outreach, and routing of treatment resources to the~     right patients at the right time.~   "
20132|NCT03303443|"~     Bispectral index (BIS), a standard monitor for perioperative monitor of patient's conscious~     level, is a noninvasive medical technique for monitoring and recording the electrical~     activity of brain.~   "
20168|NCT03302975|"~     The proposed research study aims to investigate whether a gait modification training program~     to decrease peak braking forces during the stance phase of running will result in a reduction~     in impact loading and the incidence of running-related injuries among recreational distance~     runners.~   "
26941|NCT03214341|"~     Differentiation between benign and malignant mediastinal tumors as well as characterization~     and grading of malignancy which is essential for treatment planning as well as for prognosis~   "
20133|NCT03303430|"~     Microembolisation identified on diffusion-weighted magnetic resonance imaging (DW-MRI) is~     recognized as an important outcome measure for carotid revascularization procedures such as~     carotid stenting (CAS) or carotid endarterectomy (CEA). In fact, cerebral microembolisation~     occurring during revascularization procedures is associated with an increased risk of peri-~     and post-procedural stroke, transient ischemic attack as well as neurocognitive decline.~     Carotid artery stenting is a less invasive alternative to endarterectomy to treat symptomatic~     or asymptomatic carotid stenosis. Large randomized clinical trials showed a higher~     periprocedural risk of non-disabling stroke with CAS and a higher periprocedural risk of~     myocardial infarction, cranial nerve palsy, and access site hematoma with CEA.~      However little is known regarding the correlation between the morphological characteristics~     of the carotid plaque and the occurrence of microembolisation during the procedure and~     between microembolisation and midterm cognitive impairment. A few studies suggest that plaque~     morphology may be an important determinant for the increased risk of microembolisation. These~     studies however have mainly investigated microembolisation occurring during CAS and~     exploratory studies comparing the two procedures are still lacking.~      The purpose of the present study is to determine the correlation between the morphological~     characteristics of the carotid plaque and cerebral microembolisation either after carotid~     stenting or after carotid endarterectomy in patients with symptomatic or asymptomatic carotid~     disease.~   "
20134|NCT03303417|"~     Constipation is a widespread and common problem in which a person finds it difficult and/or~     painful to open their bowels. The current treatment is the use of medications called~     laxatives. Kiwifruit is a widely available food that has been shown to possess some laxative~     properties. The cause of this is unknown. Non-invasive medical imaging techniques such as~     Magnetic Resonance Imaging now allow taking pictures of the gut and its contents. The~     Nottingham GI MRI research group specialises in these techniques and in this study use such~     images to assess the changes induced in the gut contents by kiwifruit to improve~     understanding of how it helps patients with constipation.~      The volunteers will be asked to undergo 2 studies in which they take either kiwifruit or~     placebo (sugary drink) two times a day for 2 days and then spend a study day where will they~     will be fed some more kiwifruit/placebo and some normal food and image their gut at~     intervals. Participants will be asked to complete a stool diary to determine if they~     experience a laxative effect.~   "
20135|NCT03303404|"~     To determine if 24-hr ambulatory blood pressure monitoring effects endothelial function, we~     will measure flow-mediated dilation before and after the blood pressure monitoring (ischemia~     conditioning).~   "
20136|NCT03303391|"~     This study is an open label randomized clinical trial that comparing intradialytic blood~     pressure slope-based ultrafiltration prescriptions to standard care in the chronic fluid~     management of maintenance hemodialysis patients. It also includes a cross sectional component~     evaluating the associations between intradialytic blood pressure slopes ascertained over 2~     week periods with measurements of extracellular water/body weight obtained with~     multifrequency bioimpedance spectroscopy.~   "
20137|NCT03303378|"~     Acute myocardial infarction is a major cause of mortality and morbidity. Primary percutaneous~     coronary intervention (pPCI) is currently the most effective treatment strategy in acute~     myocardial infarction. However, a sizable number of patients fail to restore optimal~     myocardial reperfusion, mostly because of the 'no-reflow' phenomenon. Melatonin is the chief~     indoleamine produced by the pineal gland, and a well-known antioxidant and free radical~     scavenger. Several studies have shown that melatonin protects against ischemia/reperfusion~     injury (IRI). In our previous study, melatonin markedly reduced infarcted area, improved~     cardiac function and reduced lactate dehydrogenase release in rats. The investigators planned~     to research the cardioprotective effects of intravenous melatonin administered prior to~     reperfusion and continued after restoration of coronary blood flow in patients with ST~     segment elevation myocardial infarction undergoing pPCI.~   "
20138|NCT03303365|"~     For patients with cerebral oligometastases who are in adequate clinical condition~     stereotactic radiosurgery (SRS) is the treatment of choice, being recommended by~     international guidelines for the treatment of one to four lesions. Newer findings have shown~     that for patients with more than four lesions SRS can be considered as a favorable~     alternative to whole-brain radiotherapy (WBRT), the currently established standard-of-care~     treatment. With modern techniques highly conformal SRS of multiple lesions has become~     feasible with comparable clinical effort and minimal toxicity as compared to WBRT.~     Developments in magnetic resonance imaging (MRI- imaging) have produced highly sensitive~     contrast-enhanced three-dimensional fast spin echo sequences such as SPACE that facilitate~     the detection of very small and early-stage lesions in a fashion superior to the established~     Magnetization Prepared Rapid Gradient Echo (MPRAGE) series.~      Since it has been established that the response of brain metastases to SRS is better for~     smaller lesions and that WBRT can come at the price of significant neurotoxicity, the~     investigators hypothesize that 1) earlier detection of small brain metastases and 2) early~     and aggressive treatment of those by SRS will result in an overall clinical benefit by~     delaying the failure of repeated localized therapy and thus preserving quality of life and~     potentially prolonging overall survival. On the other hand however, overtreatment might be a~     valid concern with this approach since it has yet to be proved that a clinical benefit can be~     achieved.~      The current study aims to stretch the boundaries of the term cerebral oligometastases by~     performing SRS for up to ten cerebral metastases, compared to the established clinical~     standard of four, given that existing data supports the non-inferiority of this approach and~     given that modern Cyberknife SRS facilitates the treatment of multiple lesions with minimal~     treatment-associated toxicity.~   "
20139|NCT03303352|"~     Summary~      Endoscopic ultrasound fine needle aspiration (EUS FNA) is an established and recommended~     technique for diagnostic of solid pancreatic masses. The accuracy of the technique depends on~     the operator experience, lesion type and location, type of procedure sedation as well as~     procedure related technique factors (presence of elastography or contrast enhanced imaging,~     needle diameter, presence of stylet, use of suction and type of suction, the number and~     method of to and fro movements, the number of passes and the presence of a cytopathologist~     in the examination room).~      The relationship between the to and fro movement and the EUS FNA yield in solid pancreatic~     masses has only been explored in the literature in a subjective fashion, without accurately~     measuring the needle acceleration.~      Recently, a simple electronic sensor device connected by Bluetooth to a phone, has been~     proposed for teaching and research purposes. Among its sensors, it includes an accelerometer~     which can measure the instant scalar acceleration of an object and transmit it to the~     connected phone. By attaching this device to the EUS FNA needle, the investigators can~     accurately measure the instant scalar acceleration of the to and fro movements.~      The investigators propose a prospective, multicenter, randomized, crossover study on 51~     patients with solid pancreatic masses to compare an EUS FNA fast sampling technique in~     which the needle acceleration is higher than 1 g to a slow technique where the needle~     acceleration is lower than 1g.~      The primary objective of the study is to compare the tissue acquisition rates and the~     histological diagnosis accuracy between the 2 methods fast and slow. The secondary~     objectives of the study are to compare the cellularity and quality scores of the obtained~     specimens between the 2 methods. Another secondary objective is to find a linear relationship~     between the needle acceleration and the EUS FNA yield (histological diagnosis, sample~     cellularity and adequacy).~   "
20427|NCT03299595|"~     This cross-sectional study will assess the prevalence of oral changes among smokers in an~     Egyptian cohort (patients attending to the hospital of Faculty of Dentistry - Cairo~     University), aiming that this study can serve as a baseline for future studies with the goal~     of finding ways to improve oral health and increase awareness of the hazards of smoking in~     Egypt~   "
20140|NCT03303339|"~     The purpose of the phase 1b/2 study is to determine whether PCM-075 given orally daily for 5~     consecutive days every 28 days is safe and tolerable in adult patients who have~     relapsed/refractory Acute Myeloid Leukemia, or are ineligible for intensive induction~     therapy, and to determine the maximum tolerated dose or recommended phase 2 dose of PCM-075~     in combination with decitabine or and PCM-075 in combination with low-dose cytarabine. In the~     phase 2 portion of the study, one regimen (either PCM-075 in combination with decitabine or~     PCM-075 in combination with low-dose cytarabine) will be studied to provide further data on~     the safety profile of the combination and to preliminarily assess the activity of the chosen~     combination in patients with untreated AML who are not candidates for aggressive induction~     therapy, or who have received one prior treatment for their AML.~   "
20141|NCT03303326|"~     This study evaluates how Arab American women's cultural values and sexual health are related~     to their physical and emotional health. The study will also examine whether engaging in a~     sexual health interview affects women's physical and emotional health.~   "
20142|NCT03303313|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of~     Cemdisiran in patients with aHUS.~   "
20143|NCT03303300|"~     The five-repetition sit-to-stand test (5R-STS) has been used in many medical disciplines, but~     has never been correlated with or validated in regard to degenerative spinal diseases. The~     investigators aim to assess the possibility of using the standardized 5R-STS as an objective~     measure of functional impairment and pain severity in patients with degenerative lumbar~     spinal diseases.~   "
20144|NCT03303287|"~     Pakistan is a developing country and there have been a considerable rise in obesity and~     hypertension in children in recent years. In this setting a focus on primary prevention of~     cardiovascular diseases is more cost effective than spending resources on secondary or~     tertiary prevention,. Primary prevention includes interventions to promote physical activity~     (> 30 minutes/day in school), healthy dietary habits (decreased consumption of sweetened~     beverages and snacks, and increased consumption of fruit and vegetables) and health education~     focusing on cardiovascular risk factors in school children. This would translate into~     healthier cardiovascular outcomes (eg. less hypertension, dyslipidemia and diabetes) in adult~     life. The investigators propose a school health education program for Pakistan (SHEPP) for~     children aged 9-11 years in 3 schools in Karachi for a period of one year. This program will~     comprise of 140 minutes physical activity/week (including aerobics):30 minutes aerobic~     PA(30*2=60) + 10 minutes (10*5=50)physical activity in assembly daily+ 1 minute between~     periods(1*6*5=30) and healthy diet and healthy heart teaching. Additionally teaching will~     also be given to teachers and parents, who will further reinforce these habits in children.~     We hypothesise that SHEPP will improve physical activity levels, dietary habits and knowledge~     about healthy heart in children, will decrease blood pressure, body mass index, waist~     circumference, at the end of the year. If this healthy behavior is carried on to adult life~     it will serve as an excellent primary prevention measure. The investigators , later on plan~     to study long term outcomes after implementation of this intervention.~   "
20145|NCT03303274|"~     Central venous catheterization is widely used for various purposes during surgery. For~     central venous catheterization, subclavian vein is selected because of the relatively low~     risk of infection, long-term patency and low patient discomfort. The cross - sectional area~     of the subclavian vein is an important factor to increase success rate. Several studies have~     reported that the Trendelenburg position increases the cross-sectional area of the subclavian~     vein, and the lateral tilt position can change the cross-sectional area of the subclavian~     vein. However, the impact of lateral tilt position to the cross-sectional area of the~     subclavian vein is not clear. The ipsilateral position can increase the cross-sectional area~     of the subclavian vein, and the contralateral position can decrease the cross-sectional area~     by gravity.~      In the second stage of this study, the investigators would like to compare the success rate,~     the number of needle passage, time to complete subclavian vein catheterization in supine and~     ipsilateral tile position.~   "
20146|NCT03303261|"~     The chronic lumbago can be associated with an active discopathie, objectified on the MRI by~     the presence of an inflammatory signal (Modic 1) or greasy (Modic 2) vertebral trays framing~     the pathological vertebral disk The treatment recommended by t consists in particular of a~     local infiltration of corticoids which the efficiency is variable according to the patients.~     The objective of this study is to estimate the efficiency of the local treatment and to~     highlight some of the factors associated to the advantage of the infiltration by corticoids.~   "
20147|NCT03303248|"~     The study looks to learn more about the helpfulness of web-based transition education and its~     effect on transition readiness and health service utilization in the adolescent and young~     adult congenital heart disease population.~   "
20148|NCT03303235|"~     Insufficient uterine tone resulting in atony can potentiate hemorrhage and adverse outcomes~     for the parturient. Oxytocin is the first pharmacologic agent used, followed by~     methylergonovine, carboprost, and misoprostol. The American Congress of Obstetricians and~     Gynecologists (ACOG) recommends the sequential use of oxytocin, followed by methylergonovine,~     carboprost, misoprostol, then surgical intervention for cases of refractory uterine atony.~     Many studies have examined the effect and dosage of intravenous uterotonics, including~     oxytocin.~      Although there are anecdotal reports of using intravenous bolus or rapid infusion of~     methylergonovine, no randomized trial has compared efficacy and side effects of these two~     routes of administration. Investigators hypothesize that intravenous methylergonovine reduces~     the time to adequate uterine tone (the tone at which the uterus is adequately contracted to~     prevent atony after delivery of neonate), decreases the total dose of methylergonovine to~     contract the uterus, and therefore produces fewer side effects of hypertension, nausea, and~     vomiting. Reducing the time to achieve adequate uterine tone is likely to decrease postpartum~     hemorrhage.~   "
20149|NCT03303222|"~     Measure trimethylamine oxide in the breath.~   "
20182|NCT03302793|"~     This study looks at the effect of combined breathing-controlled electrical stimulation~     (BreEStim) and transcranial direct current stimulation (tDCS) on neuropathic pain after~     spinal cord injury, amputation, or brain injury. The hypothesis is that a single session of~     combined BreEStim and tDCS will produce an additive analgesic effect. This record covers the~     study in a population of spinal cord injury patients. Note that this study will also enroll~     healthy volunteers, brain injury patients, and amputation patients and that this study as~     applied to these other populations will be covered in separate ClinicalTrials.gov records.~   "
20150|NCT03303209|"~     This is an observational study of a voluntary opioid tapering protocol conducted in community~     outpatients taking long term prescription opioids for chronic pain. Patients who would~     otherwise continue with their existing opioid prescriptions were encouraged to participate in~     a voluntary opioid taper program. Interested patients were identified by their pain~     physician, Dr. Richard Stieg, and then completed an online informed consent document and~     baseline self-report assessments including types and doses of opioid medications as well as~     demographic and psychosocial measures, clinical and pain characteristics. Patients were~     either given or mailed a free copy of a patient book The Opioid-Free Pain Relief Kit, or Less~     Pain, Fewer Pills: Avoid the dangers of prescription opioids and gain control over chronic~     pain. Over the following weeks and up to 4 months, Dr. Stieg implemented a slow, individually~     tailored opioid taper in all patient participants. Follow-up online self-report surveys were~     completed at 4 months post enrollment. Opioid dose data were confirmed via medical chart~     review, and doses were converted to a standardized morphine equivalent daily dose (MEDD).~     Main outcome was change in opioid dose baseline to 4 months. Secondary outcome was change in~     pain intensity (numeric rating scale, 0-10) baseline to 4 months.~   "
20151|NCT03303196|"~     This is a pilot study designed to determine if the bihormonal bionic pancreas provides~     improved blood glucose control, compared to the current standard of care, in individuals with~     hyperinsulinism who developed diabetes after having a pancreatectomy.~   "
20152|NCT03303183|"~     The purpose of this study is to determine the scan quality of the direct ear scanner~     concerning consistency, accuracy and reliability and to compare the data to common silicone~     ear impressions by benchmarking the outcome of each impression technique on custom product~     dummies on participants.~   "
20153|NCT03303170|"~     Prospective, randomized, controlled, parallel group clinical study with blinded assessment~     evaluating Sebacia Microparticles (SM) with Nd:Yag laser in facial inflammatory acne vulgaris~   "
20154|NCT03303157|"~     a case study of a man with a unique condition that negatively affects his sleep architecture.~     we want to study this man's sleep and see (through interviews) how his condition affects his~     ability to dream~   "
20155|NCT03303144|"~     The main purpose is to establish the equivalence of Triferic iron administered via dialysate~     into the arterial blood line and into the venous blood line~   "
20156|NCT03303131|"~     Retrospective analysis of routine program data of children aged 6 to 59 months admitted to~     the MSF therapeutic feeding program with MUAC ≤ 118 mm in Yako and Titao districts of Burkina~     Faso from 2007-2011.~   "
20157|NCT03303118|"~     The investigators will investigate the effect of hypobaria and hypoxia on physiological~     responses such as: oxygen saturation, heart rate, cerebral blood flow, cerebral oxygenation,~     brain's activity and concentration performance.~   "
20158|NCT03303105|"~     To evaluate the long-term safety and tolerability of subcutaneous (SC) administration of~     TEV-48125 (at 225 mg once monthly [except for a loading dose of 675 mg for CM patients] or at~     675 mg every 3 months) for the preventive treatment of Chronic Migraine and Episodic Migraine~     patients~   "
20159|NCT03303092|"~     To evaluate the efficacy and safety of subcutaneous (SC) administration of TEV-48125 (monthly~     TEV-48125 225 mg and TEV-48125 675 mg once over a period of 3 months) compared with placebo~     for preventive treatment in Episodic Migraine patients~   "
20160|NCT03303079|"~     To evaluate the efficacy and safety of subcutaneous (SC) administration of TEV-48125 [monthly~     TEV-48125 225 mg (loading dose only: 675 mg) and TEV-48125 675 mg once over a period of 3~     months] compared with placebo for preventive treatment in Chronic Migraine patients~   "
20161|NCT03303066|"~     The objective of this study to evaluate the efficacy and safety of FG-4592 for the treatment~     of anemia in Chinese subjects with lower risk MDS.~   "
20162|NCT03303053|"~     Hyperthyroidism is the second most common endocrine disorder in the world with Graves'~     disease being the commonest. Anti thyroid drugs including methimazole, carbimazole, and~     propylthiouracil are effective treatments but take in most cases between 6 to 8 weeks to~     achieve euthyroidism. This study aim to assess the efficacy of cholestyramine and~     prednisolone as adjunctive treatment to standard treatment in patients with overt~     hyperthyroidism in 4 weeks.~   "
20163|NCT03303040|"~     During major surgical procedures general anesthesia is used to make the patient unconscious.~     General anesthesia insures that the patient is unaware of any pain caused by surgery. General~     anesthesia also prevents the patient from moving to prevent any potential surgical error. At~     the same time general anesthesia makes it impossible for the patient to breathe. To help the~     patient breathe a breathing tube is placed into the patient's airway and connected to the~     mechanical ventilator. A mechanical ventilator is an artificial breathing pump, which~     delivers gas into a patient's airways.~      The purpose of this research study is to determine if brief periods of diaphragm stimulation~     can prevent diaphragm problems caused by the use of mechanical ventilators and surgery. To~     answer this question the changes in the genes responsible for maintaining diaphragm function~     will be studied. A gene is the code present in each cell in your body and controls the~     behavior of that cell. In addition, the changes in the contractile properties of muscle~     fibers will be studied. The results from this study may help develop new treatments to~     prevent diaphragm weakness resulting from mechanical ventilation use.~   "
20164|NCT03303027|"~     Traditionally, dermatologic surgeons close wounds with stitches. Fast absorbing gut is a~     dissolvable stitch that is very commonly used. Some surgeons believe that using a thinner~     size of this stitch causes less skin reaction and improves the cosmetic outcome of the scar.~     Other surgeons believe that using a thicker size of this stitch reduces the tension on the~     scar and improves the cosmetic outcome of the scar in that manner. The investigator wishes to~     determine whether the thickness of the fast absorbing gut suture that is used makes a~     difference in the cosmetic outcome of the scar.~   "
20165|NCT03303014|"~     When using suture (stitches) to close wounds, surgeons can use suture that is absorbable or~     non-absorbable. Absorbable sutures naturally break down. Non-absorbable sutures need to be~     removed. We wish to determine how the cosmetic result of a specific absorbable suture (fast~     absorbing gut) compares to that of a specific non-absorbable suture (prolene).~   "
20196|NCT03302611|"~     This study uses a randomized controlled trial design to compare the psychological effects of~     surf therapy to hike therapy in active duty service members who have been diagnosed with~     major depressive disorder.~   "
20169|NCT03302962|"~     Asthma is a chronic lung disease with serious morbidity and potential mortality. Multiple~     physiologic, environmental and social conditions impact the prevalence and severity of~     asthma. Even when diagnosed, effective control can be impeded by improper use of medication,~     not understanding or being unable to avoid environmental triggers, lack of continuity in~     follow-up care, and lack of an asthma action plan. American Indians are especially at-risk~     for health problems related to asthma. American Indians have the highest asthma rate among~     single-race groups; 18.5% of American Indians are diagnosed with asthma, while only 11% are~     diagnosed with asthma in the general population but little is known about why this is true.~     Asthma is a prototypic example of the interaction of biologic, environmental and psychosocial~     influences on disease and this study investigated the possible improvement in asthma control~     from an intensive educational intervention.~   "
20170|NCT03302949|"~     Undernutrition at the time of diagnosis of active tuberculosis is a risk factor for increased~     mortality, and lack of weight gain during anti-tuberculous treatment has been linked to an~     increased relapse risk. The purpose of this study is to test the effect of Lacprodan® DI-8090~     whey protein concentrate on anthropometric measures, treatment outcome and health-related~     quality of life, against standard practice during anti-tuberculous treatment on patients with~     a BMI <20 living in Guinea-Bissau.~   "
20171|NCT03302936|"~     There has been preliminary data showing that pyridium can decrease the risk of difficulty~     urinating after midurethral sling. This study is designed to have two groups of patients. One~     group will receive pyridium pre-operatively, while the other group will have routine~     preoperative care. Both groups will have their bladder tested prior to going home. It will be~     evaluated if there is a difference in the difficulty to urinate post-operatively in both~     groups.~   "
20172|NCT03302923|"~     It is well established that physical activity reduces the physiological effects of ageing.~     Among them, the decrease of the autonomic nervous system activity (ANS) is associated with~     the increase of cardiovascular events and sleep disorders occurence. It has been shown that~     high intensity cycle training can enhance the ANS activity by 30% in people aged of 70 years~     old. However, such trainings were done by old athletes used to train at intensities that~     could not be handled by nursing home elderly. Thus, an adapted activity such as brisk walking~     shall be defined to make it practicable for the many in convalescent homes. The investigators~     hypothesize that long term brisk walking training could lead to reactivate ANS in people~     living in convalescent homes.~   "
20173|NCT03302910|"~     The majority of the over one million annual AHF hospitalizations originate from the emergency~     department. Admitting and re-admitting lower risk AHF patients who don't need prolonged~     hospitalization may increase their risk for poor outcomes and decrease their quality of life:~     Safe alternatives to hospitalization from the ED are needed. We propose a strategy-of-care,~     short stay unit management of AHF (i.e. less than 24 hours), will lead to improved outcomes~     for lower risk AHF patients.~   "
20174|NCT03302897|"~     The purpose of this study is to compare the safety, tolerability, and immunogenicity in~     healthy adult subjects of an investigational vaccine being developed for the prevention of~     leprosy. Two dose levels of the vaccine will be evaluated.~   "
20175|NCT03302884|"~     Prospective multicentre assay to assess ctDNA value for ovarian cancer monitoring and disease~     recurrence after front-line treatment.~   "
20176|NCT03302871|"~     Evidence from literature support the use of Botulinum toxin A (BoNT-A) for upper limb~     spasticity management in children with cerebral palsy (CP). Constraint Induced Movement~     Therapy (CIMT) and Bilateral Intensive Training (BIT) are indicated as effective and~     complimentary treatments to improve motor function in these children. In a recent trial~     combined noninvasiv brain stimulation and CIMT enhanced therapy induced functional gains.~      In this clinical trial the aim was to evaluate the effects of transcranial direct current~     stimulation (t-DCS) plus intensive hybrid training model of modified CIMT and BIT when~     integrated with BoNT-A treatment in children with unilateral CP.~   "
20177|NCT03302858|"~     The purpose of this research is to assess the safety and effectiveness of circumferential~     radiofrequency ablation (RFA) to the anal canal using the BarrxTM Ablation System to destroy~     anal high-grade squamous intraepithelial lesions (HSIL). The BarrxTM Ablation System used in~     this study comprises an RFA generator (Barrx™ FLEX) and the BarrxTM Anorectal Wand. The~     generator and wand are cleared by the Food and Drug Administration (FDA) for human use and~     the wand is specifically cleared for treatment of anal intraepithelial neoplasia (AIN). AIN~     is a precancerous condition. HSIL is an advanced form of AIN. The presence of HSIL has~     traditionally warranted treatment. RFA has been shown in many studies to effectively and~     safely destroy precancerous cells in a condition called Barrett's esophagus, which is a~     precancerous condition of the esophagus (the swallowing tube). Recent studies have shown that~     RFA may offer the same benefits for those with HSIL in the anal canal. In particular,~     ablation of the entire circumference of the canal seems to reduce recurrence of HSIL in other~     locations of the anal canal.~      This study will last between 12 to 15 months. Subjects will be required to undergo 5 to 8~     study visits as outlined below that are carried out by the study doctors or the physician~     assistant. Most visits will last approximately one hour. Some may be shorter and some may be~     longer. Up to seventy (70) volunteers will participate in this study at several locations.~   "
20178|NCT03302845|"~     This drug-drug interaction study will evaluate the impact of two different acid reducing~     agents (from two different drug classes) co-administered with a single dose of telotristat~     ethyl.~   "
20179|NCT03302832|"~     Rehabilitation after Total Knee Arthroplasty surgery involves physical therapy services to~     address limitations in range of motion, strength, and participation in normal daily~     activities. This investigation will compare the outcomes from standard physical therapy~     intervention in comparison to reduced frequency physical therapy sessions supplemented with~     in-home exercise equipment.~   "
20180|NCT03302819|"~     The MARIA breast imaging system is a novel CE-marked radio-frequency (RF) medical imaging~     device. The system employs an electromagnetic imaging technique that exploits the dielectric~     contrast between normal and cancerous tissues. The performance and imaging characteristics of~     MARIA are not yet well demonstrated. The investigators aim to evaluate some aspects of this~     potentially important new technology.~   "
20181|NCT03302806|"~     The purpose of this observational study is to collect efficacy and safety data in real life~     condition within the first year of treatment in patients with progressive multiple receiving~     a daily dose of biotine of 300 mg.~   "
20183|NCT03302780|"~     This study looks at the effect of combined breathing-controlled electrical stimulation~     (BreEStim) and transcranial direct current stimulation (tDCS) on neuropathic pain after~     spinal cord injury, amputation, or brain injury. The hypothesis is that a single session of~     combined BreEStim and tDCS will produce an additive analgesic effect. This record covers the~     study in a population of healthy volunteers. Note that this study will also enroll spinal~     cord injury patients, brain injury patients, and amputation patients and that this study as~     applied to these other populations will be covered in separate ClinicalTrials.gov records.~   "
20184|NCT03302767|"~     This patient support system is designed to help patients regain their professional activity~     after their treatment. It's a 3-Axis neuropsycho-social synergy on 3 axes:~        -  A weekly pluridisciplinary consultation in tandem (Social worker + Psychologist /~          Neuropsychologist)~        -  Monthly information meetings and workshops (TIC'Onco reunions: collective information~          times and Cogit'Onco workshops: cognitive workshops~        -  An information booklet Prepare the work return The aim of this research is to evaluate~          efficiency in term of quality of life improvement linked to work status, utility,~          feasibility and patients' satisfaction.~      The aim of this research is to evaluate efficiency in term of quality of life improvement~     linked to work status, utility, feasibility and patients' satisfaction.~   "
20185|NCT03302754|"~     The purpose of this study is to conduct a pilot trial of a Precision Dosing approach to~     alemtuzumab dosing for allogeneic hematopoietic cell transplantation of patients with~     non-malignant diseases. The investigators will measure the ability to use a population PK~     model of alemtuzumab to target patient Day 0 alemtuzumab levels to 0.15-0.6ug/mL in a pilot~     study of 20 patients.~   "
20186|NCT03302741|"~     The purpose of this study is to evaluate if it is possible to use a new 3D imaging method to~     guide Botulinum neurotoxin (BTX) injection for muscle spasticity management after stroke.~     This imaging method is called three dimensional innervation zone imaging, or 3DIZI.~   "
20187|NCT03302728|"~     This study is investigating the combination of Brentuximab vedotin and lenalidomide in the~     treatment of relapsed/refractory peripheral T cell lymphoma or cutaneous T cell lymphoma or~     Hodgkin lymphoma.~      It is hypothesised that lenalidomide may augment the actions of Brentuximab vedotin in these~     patient groups. The primary objective of the study is to determine the maximum tolerated dose~     of the combination treatment, which can be used in subsequent studies. The study will also~     investigate disease response and survival.~      Participants will receive Brentuximab vedotin (once every 21 days i.e. 1 cycle) and~     lenalidomide (daily from day 1 -14 of each cycle) for a maximum of 48 weeks and will be~     followed for a subsequent 6 months after the end of treatment.~   "
20188|NCT03302715|"~     Colorectal illness contributes significantly to the global burden of disease. Cancer,~     inflammatory bowel disease and diverticulosis result in substantial patients suffering and~     health care expenditures. The causes of colorectal diseases remain unclear.~      New data suggests that intestinal bacteria may play a major role in the causal chain for many~     diseases, and the research on the microbial environment in the colon in relation to bowel~     disease is increasingly intense although the possibility for analysis of the composition of~     bacteria in the gut has so far been limited. However, new analytic methods based on powerful~     DNA sequencing, opens new opportunities.~      In the surgical clinic at Danderyds hospital, Stockholm, 2500 colonoscopies are performed per~     year. The investigators have created a biobank with mucosal samples from patient's large~     bowel and will consecutively include all patients scheduled for colonoscopy during one year~     (N=2500). Biopsies from the colonic mucosa will be analysed in collaboration with the~     Clinical Genomics, Science for Life laboratory (Karolinska Institutet).~      In Phase 1, the association between specific bacteria and colorectal disease will be~     investigated (hypothesis generating phase). In Phase 2, the investigators aim to identify~     specific bacterial biomarkers that could be used as screening tools, and lay the ground for~     future new treatments for colorectal disease.~      Early detection and new treatment regimes would result in both significant patient benefits~     as well as reductions in healthcare costs.~   "
20189|NCT03302702|"~     We aimed to compare the functional results of the 8th week with the results of the 12th week~     of the exercise programs applied to the patients with ILD.~   "
20190|NCT03302689|"~     Randomized, double-blind, controlled trial: a comparison of Levobupivacaine and Ropivacaine~     for postoperative analgesia using TAP-block~      Objectives:~        1. VAS score during the first 12 hours~        2. Determine which drug is more effective for postoperative analgesia in the first 12 hours~          after surgery~        3. Side effects~   "
20191|NCT03302676|"~     This study evaluates the possible benefits of a tasteless and sugar free chewing gum as a~     salivary stimulant for head and neck cancer patients treated with curative intended~     radiotherapy.~   "
20192|NCT03302663|"~     This project is split into 4 sections:~        1. Can improvements be made in the Magnetic resonance imaging sequences used to image the~          fetus in order to improve diagnostic accuracy?~        2. Does 3T improve the quality and diagnostic value of fetal MRI when compared to 1.5T~        3. Can fetal MRI be used to image the fetal heart?~        4. Can fetal MRI be used to image the fetal Bones?~   "
20193|NCT03302650|"~     This study aims to investigate the effect of angiotensin II on microcirculation and~     peripheral perfusion in patients with septic shock.~   "
20194|NCT03302637|"~     This is a prospective population based study to examine the relationship of oral and~     pancreatic microbiome, and their functions, to pancreatic cancer risk.~      The identification of specific oral bacteria and their functional relationship to pancreatic~     cancer will advance scientific knowledge on the etiology of pancreatic cancer. This could~     provide a new microbially-based research paradigm, possibly leading to new drug targets for~     this disease. Second, the oral bacteria may serve as a readily accessible, non-invasive~     biomarker for subsequent pancreatic cancer risk, which help to identify people at high risk~     of this disease. Finally, the identified oral bacteria may lead to microbial prophylactic~     preventions, with antibiotic therapy aimed at eradicating the specific species associated~     with increased cancer risk or, alternatively, combined with probiotics to introduce species~     that are associated with a decreased cancer risk. Thus, the study outcomes will lead to~     actionable means for pancreatic cancer prevention.~   "
20195|NCT03302624|"~     Acute kidney injury (AKI) involves poor prognosis in ICU patients. The renal prognosis at~     long term is unknown.~      The study will determine chronic kidney injury incidence and quality of life, five years~     after AK during ICU stay.~   "
20198|NCT03302585|"~     This is a phase II randomized double-blind placebo/standard of care trial to determine if~     rapidly inducing vitamin D sufficiency in patients with acute optic neuritis results in less~     damage/greater recovery at 12 months as measured by optical coherence tomography, visual~     evoked potentials, visual acuity and radiological measures. Our hypothesis, based on earlier~     observational studies, is that acute optic neuritis in the context of vitamin D sufficiency~     results in better visual outcomes compared to those that are not sufficient acutely,~     regardless of such interventions as steroid therapy.~   "
20199|NCT03302572|"~     The knowledge and completion of advanced directives (ADs) by the population is generally low.~     Primary care could develop a very important role to inform and assist in the preparation of~     this document because of its accessibility.~      Objective: To evaluate the effectiveness of an oral brief information and a brochure~     administered in primary care to improve the proportion of ADs records.~      Design: Randomized clinical trial. Ambit: 7 offices from a urban health center which serves~     about 25,000 users older than 18 years.~      Material and methods It will be administered randomly triptych and oral brief information~     about the existence of advance directives for people over 18 to attend the appointment of~     their family doctor for any reason (intervention group). It will be given the possibility of~     more extensive information if they wish and collaboration will be offered for the advance~     directive according to patient preferences. The control group will not receive any~     information. Follow-up: 3 months. Variables will be: number of people interested in ADs,~     number of ADs made and demographic data (gender, age, education level, race, comorbidities,~     religion, testament) in both groups. Statistical analysis: multiple linear regression,~     Poisson and Cox as response analyzed, with the intervention/control group as the main~     variable adjusting for potential confounders. Bivariate comparison using Student t test or~     Mann-Whitney test (continuous variables) and chi-square or Fisher's exact test (categorical~     variables). 165 subjects were required in the control group and 165 in the intervention~     group.~      Conclusion: positive results of this study will bring out the brief information managed by~     family physicians increases the number of ADs thus facilitating the right to autonomy of the~     patient.~   "
20200|NCT03302559|"~     This study will assess the cosmetic changes of a cosmetic topical retinoid product in~     participants with moderate to severe photodamage utilizing non-invasive in vivo skin imaging~     instrumentation.~   "
20201|NCT03302546|"~     The Hemodialysis Unit of the Hospital Ramon y Cajal is a pioneer in the implementation of a~     program of incremental hemodialysis, starting with two sessions a week in patients with~     residual renal function.~      The main objective is to compare whether the initiation of hemodialysis with two sessions a~     week over conventional pattern of initiation of three sessions a week better preserves~     residual renal function.~   "
20202|NCT03302533|"~     Total elbow arthroplasty (TEA) results in immediate pain release with good functional results~     after distal humerus fractures. But still open reduction and internal fixation is recommended~     as treatment of choise due to a lifelong loading limitiation, unknown implant survival and~     problematic revision surgery after TEA. The purpose of this study was to compare functional~     results and complication rates after primary total elbow arthroplasty (TEA) and TEA after~     failed reconstruction or non-operative treatment (secondary TEA) in the treatment of distal~     humerus fractures. We hypothesised that clinical and functional results are better for~     primary TEA with less complications.~   "
20203|NCT03302520|"~     The authors aimed to compare the clinical efficacy and safety of CaO-SiO2-P2O5-B2O3 glass~     ceramics with PEEK cage that is widely used for posterior lumbar interbody fusion (PLIF)~     surgery in the clinical field.~   "
20204|NCT03302507|"~     This study is to compare the clinical outcome between the biportal endoscopic decompression~     and the unilateral approach bilateral decompression in spinal stenosis~   "
20205|NCT03302494|"~     The WAVECREST 2 trial is a prospective, multicenter, randomized, active controlled, clinical~     trial to evaluate the safety and effectiveness of the Coherex WaveCrest Left Atrial Appendage~     (LAA) Occlusion System.~   "
20206|NCT03302481|"~     The study aims to characterize mitochondrial metabolism in the liver of obesity surgery~     patients and to study its relationships with hepatic steatosis, inflammation, and fibrosis.~   "
20207|NCT03302468|"~     Endometriosis and adenomyosis can impact on the quality of life including the physical,~     psychological and social aspects. It is important to include quality of life measurements in~     evaluating the disease severity and response to any given treatment. The 30-item~     Endometriosis Health Profile (EHP-30), derived from in-depth interviews of patients with~     endometriosis, is currently the most reliable questionnaire for health-related quality of~     life measurement in women with endometriosis. It includes specific questions addressing the~     problems faced by patients with endometriosis.~      Unfortunately, this widely accepted tool does not have a traditional Chinese version for the~     measurement of health-related quality of life of endometriosis in Hong Kong. Furthermore,~     adenomyosis and endometriosis share similar histological and clinical symptomatology, but~     application of EHP-30 to adenomyosis has never been studied.~      The aims of the present study are to translate the EHP-30 English version into traditional~     Chinese version and to evaluate its psychometric properties in endometriosis and adenomyosis.~      The hypothesis of this study is that EHP-30 (Hong Kong) traditional Chinese questionnaire has~     high internal consistency, construct validity, reproducibility as the original English~     version and can be applicable to Hong Kong Chinese women with endometriosis and adenomyosis.~   "
20208|NCT03302455|"~     Short-term insomnia is one of the most common sleep disorders. Online cognitive behavioral~     therapy for insomnia (e-aid Cognitive Behavioral Therapy for Insomnia, eCBTI) has received~     wide attention in recent years. Foreign countries already have some eCBTI treatment tool,~     shown similar efficacy as standard CBTI, but how eCBTI can help in short-term insomnia~     disorders require further exploration and examination.~      In this study, Investigators will establish eCBTI treatment tool to test whether eCBTI can~     reduce the conversion of short-term insomnia disorder to chronic insomnia disorder; and~     whether they can reduce short-term insomnia, anxiety, depression and improve quality of life~   "
20209|NCT03302442|"~     The aim of this observational study is to compare Dimethyl fumarate (DMF) and Teriflunomide~     on both clinical and MRI outcomes in patients with relapsing-remitting multiple sclerosis~     (RRMS) from French Observatory of Multiple Sclerosis (French MS cohort )~   "
20210|NCT03302429|"~     P- Maxillary alveolar cleft defects I- Platelet-rich fibrin (PRF) combined with biphasic~     calcium phosphate (BCP) C- Autogenous bone graft O- Outcome measure : bone height, bone~     volume, hospital stay, operation duration T- 6 months S- Randomized controlled clinical trial~     this study aimed to answer a clinical question whether the use of Platelet-rich Fibrin (PRF)~     combined with Biphasic Calcium Phosphate (BCP), can be an alternative to autogenous bone~     graft in reconstruction of alveolar cleft defect in maxillary arch.~   "
20211|NCT03302416|"~     To determine if [C-11]NOP-1A receptor binding (VT) can be altered by an intravenous~     hydrocortisone (cortisol) challenge through CRF-NOP interactions~   "
20212|NCT03302403|"~     A single arm, open-label pilot study is designed to determine the safety, efficacy and~     cytokinetics of CAR T cells in patients with malignant tumors with positive antigen targets.~      CAR T cells are genetically engineered to express single-chain variable fragment (scFv)~     targeting indication-specific antigens.~      The investigational CAR T cells and proposed indications are as follows:~      CAR-CD19 T cells for B cell leukaemia/lymphoma; CAR-BCMA T cells for myeloma; CAR-GPC3 T cell~     for hepatocellular carcinoma; CAR-CLD18 T cells for pancreatic carcinoma and adenocarcinoma~     of esophagogastric junction.~   "
20213|NCT03302390|"~     This study aims to elucidate the role of Chemokine and chemokine receptor in the pathogenesis~     of Psoriasis by using human psoriasis skin xenograft SCID mouse model. The hypothesis is that~     chemokine and chemokine receptor play important roles in psoriasis and establishment of human~     skin xenograft mouse model provide excellent platform to test the hypothesis.~   "
20214|NCT03302377|"~     This study will investigate the feasibility of an intervention to increase physical activity~     in pregnant women with diabetes by incorporating a brief in-person counseling session and~     Fitbit activity trackers into routine clinical care~   "
20215|NCT03302364|"~     Risperidone is a selective monoamine receptor antagonist. It plays an antipsychotic effect by~     antagonizing 5-HT2 / D2 receptor. As a second-generation antipsychotic drug, risperidone is~     metabolized to 9-hydroxy Risperidone in the body very quickly. There are individual~     differences in the pharmacokinetics and pharmacodynamics of risperidone. For example, CYP2D6~     genotype can greatly affect the metabolism of risperidone, and provide evidence for adjusting~     the type and dose of medication to treat Schizophrenia. In this study, we will verify the~     correlation between the polymorphisms of genes related with risperidone drug metabolites,~     drug transporters, drug targets and drug metabolism, pharmacodynamics, adverse reactions in~     Chinese population, providing basis for clinical rational use of risperidone.~   "
20216|NCT03302351|"~     Shivering is defined as an involuntary, repetitive activity of skeletal muscles. The~     incidence of shivering has been found to be quite high, approximately 40-50% in different~     studies. It can double or even triple oxygen consumption and carbon dioxide production.~     Shivering also increase intraocular and intracranial pressure, and may contribute to~     increased wound pain, delayed wound healing, and delayed discharge from post-anaesthetic~     care. Apart from being an uncomfortable experience, its deleterious effects deserve primary~     prevention and rapid control on occurence.~   "
20217|NCT03302338|"~     Amniotic fluid plays a significant role in fetal gut maturation and development. The human~     fetus swallows over 200 ml of amniotic fluid per kilogram of weight each day and such~     swallowing is essential for normal small bowel development.Growth factors found in the~     amniotic fluid have been shown to promote proliferation of fetal intestinal cells. As feeding~     intolerance is a common problem among neonates recovering from surgery for congenital bowel~     abnormalities, the investigators will study the role of enteral administration of simulated~     amniotic fluid solution in prevention of feeding intolerance and NEC in neonates recovering~     from GIT surgeries.~   "
20218|NCT03302325|"~     1. To demonstrate the ability to detect specific cancer mutations in ctDNA isolated from~          plasma of stage IV cancer patients at HCC.~        2. To compare, in each patient, ctDNA longitudinal samples through treatment, and when~          available, with those of primary tumor and metastasis.~   "
20219|NCT03302312|"~     This qualitative study will use focus groups, small group interviews, and individual~     interviews (both in person and over the phone) to compile a range of perspectives on service~     members' decision-making processes and information needs related to Stellate Ganglion Block~     (SGB). Participants will include service members, spouses, and providers.~   "
20220|NCT03302299|"~     The Alcohol Drinkers' Exposure to Preventive Therapy for TB (ADEPTT) will examine the safety~     and tolerability of, and adherence to, 6 months of daily INH (6H) in 300 TB and HIV-infected~     persons (200 drinkers and 100 non-drinkers) in Uganda. The first aim is to evaluate the~     safety and tolerability of 6H overall and by level of alcohol use. The second aim is to~     estimate adherence and compare adherence by level of alcohol use and at 3 and 6 months.~     Self-reported measures of alcohol use will be augmented by phosphatidylethanol (PEth), an~     established biomarker of alcohol use. Objective measures of adherence will include electronic~     pill bottle monitoring and a novel measure of INH exposure, INH concentration in hair. The~     study will actively monitor for hepatotoxicity using the U.S. standard of care for TB~     preventive therapy for heavy drinkers and discontinue if any Grade 3/4 toxicities are~     detected. The investigators will use the safety, tolerability, and adherence results,~     together with the known efficacy and mortality benefit of TB preventive therapy in~     HIV-infected persons in SSA, and an established decision analytic model of TB preventive~     therapy to conduct the third aim: to determine whether the benefits of TB preventive therapy~     outweigh the toxicity risks for HIV-infected drinkers in resource limited settings. The study~     will additionally follow the cohort every 6 months after completing INH to monitor drinking~     and the development of active TB.~   "
20221|NCT03302286|"~     About 6000 heart operations are performed in Sweden every year. A heart-lung machine is used~     almost exclusively in all heart operations. This machine fills the role of heart and lungs~     during surgery while the heart is stopped. The extra corporeal circuit (ECC) prime results in~     hemodilution, as assessed from the decrease in haematocrit, electrolyte concentration and~     total protein content. This hemodilution is an unavoidable consequence of the use of a~     heart-lung machine with nonblood ECC prime. The alteration of the patient´s blood volume and~     electrolytes is affected by the prime solution and can be maintained within normal limits.~     There are no clear recommendation regarding prime components and numerous prime solutions are~     in use worldwide.~      The aim of this study is to investigate whether the use of mannitol in heart-lung machine~     prime has an effect on electrolytes levels and osmolality when compared with patients who~     receive no Mannitol.~   "
20223|NCT03302260|"~     IMPROVE is a pilot RCT with a behavioral intervention component (CardioPrevent program). The~     primary objectives of this pilot study are to assess the feasibility of the implementation of~     a postpartum CVD prevention lifestyle program in women with a HDP as well as the~     transferability and fidelity of the Ottawa-based CardioPrevent® program to a centre in~     Calgary (following a Train the Trainer model). Secondary objectives include an initial~     evaluation of the effectiveness of this intervention on clinical outcomes and measures of~     microvascular function between study arms at one year.~   "
20224|NCT03302247|"~     Metastatic non small cell lung cancer can be treated with cytotoxic chemotherapy or using~     recently approved immunotherapy with antibody, Nivolumab. Both the therapies have limitation~     due to development of tolerance or immunosuppression. This trial combines one drug from each~     category, immunotherapeutic Nivolumab and chemotherapeutic gemcitabine as it was reported~     that gemcitabine reduces immunosuppression by killing myeloid derived suppressor cells,~     thereby increasing the efficacy of Nivolumab.~   "
20225|NCT03302234|"~     The purpose of this study is to determine the efficacy of pembrolizumab given in combination~     with either ipilimumab or placebo as first-line treatment in participants with metastatic~     non-small cell lung cancer (NSCLC). The primary hypothesis of this study is that overall~     survival (OS) and/or progression-free survival (PFS) is prolonged in participants who receive~     pembrolizumab and ipilimumab compared to those who receive pembrolizumab and placebo.~   "
20226|NCT03302221|"~     The investigators designed a study to assess whether there were any blood flow indexes change~     during anesthesia induction with doppler ultrasonography~   "
20227|NCT03302208|"~     In this study the investigators hypothesized that preoperative pregabalin tablet (150 mg~     orally ) may be effective in reducing intraoperative isoflurane requirements needed to~     maintain intraoperative hemodynamics within ± 20% of baseline measurement and/or attenuates~     hemodynamic response to endotracheal intubation in female patients ASA I or II , aged 18-60~     years, schedule for elective abdominal hysterectomy surgery under general anesthesia.~   "
20228|NCT03302195|"~     Standard Heparin management, based on total body weight, is not well established for obese~     patients undergoing cardiac surgery with cardiopulmonary bypass (CPB).~      The purpose of this study is to assess the safety and efficacy of using lean body mass (LBM)~     to determine pump flow rate and/or Heparin dosage in obese patients undergoing CPB.~   "
20229|NCT03302182|"~     The purpose of this study is to evaluate the pharmacokinetics and bioequivalence of Ritonavir~     tablet 100 mg versus NORVIR 100 mg tablet in healthy Chinese adult participants under fasting~     or fed condition.~   "
20230|NCT03302169|"~     This is a prospective randomized controlled trail to assess early urinary continence recovery~     rates after robotic assisted radical prostatectomy when a posterior rhabdosphincter~     reconstruction is performed or not. A hundred forty-six patients with clinically localized~     and histological confirmed prostate cancer will be enrolled. Continence recovery is defined~     in the present study as declared urinary continence (absence of incontinence episodes) in the~     physician interview as no pad use. Continence rates will be explored also by EPIC, ICIQ-SF,~     IPSS questionnaires 1, 6 and 12 months after the procedure. The sexual function as the~     secondary objective will be assessed by SHIM questionnaire.~   "
20231|NCT03302156|"~     The goal of this research is to determine the accuracy of PSMA positron emission tomography~     (PET) and multi-parametric magnetic resonance (MR) imaging to detect the presence of~     gynecological cancer cells in the body.~   "
20232|NCT03302143|"~     Total of 48 subjects were randomly assigned to treatment groups:~      UT Health Science Center at San Antonio Chi Mei Medical Center, Tainan, Taiwan~      Patients require a maxillary non-molar extraction site that is planned to be replaced by a~     dental implant and crown. This includes Straumann BL SLActive: Narrow (3.3mm) & Regular~     (4.1mm) Crossfit implants in all available lengths.~      Patients were randomly selected to receive either FDBA (test) or Autogenous bone + DBBM~     (control/standard) for contour augmentation.~   "
20233|NCT03302130|"~     Measuring brain perfusion is biased by a inter- and intrasubject variability, caused by~     physiological and lifestyle factors. In this study, the investigators want to investigate the~     effects of a different mood state (neutral, positive and negative mood), induced using~     subjects own memories, on both global and regional cerebral perfusion, measured with arterial~     spin labeling.~   "
20234|NCT03302117|"~     This is study is to assess pulmonary and systemic effects of exposure to wood smoke. Healthy~     volunteers will be expose under two different occasion to wood smoke and filtered air under~     two separated occasions with an interval of 3 weeks in-between. The aim of this study was to~     determine whether exposure to wood smoke from incomplete combustion would elicit airway~     inflammation in humans.~   "
20235|NCT03302104|"~     In our study, we used data from 4,758 healthy adults from the 1999-2002 National Health and~     Nutrition Examination Surveys to examine the associations between evidence-based diet quality~     indices and leukocyte telomere length. Our study assessed the four most widely recognized and~     commonly used diet quality indices in nutritional epidemiology: the USDA-developed Healthy~     Eating Index-2010, the Alternate Healthy Eating Index-2010, the Mediterranean Diet Score, and~     the DASH diet score. Analyses were adjusted for sociodemographic and health variables known~     to influence dietary intake and cellular aging.~   "
20236|NCT03302091|"~     The primary objective of the current study is to investigate the influence of moderate renal~     impairment on the pharmacokinetics of multiple doses in comparison to a matched control group~     with normal renal function.~   "
20237|NCT03302078|"~     The primary objective of this trial is to investigate the effect of food on the~     pharmacokinetics of the oral tablet formulation of BI 1015550 by investigating the relative~     bioavailability of TF1 under fed and fasted conditions.~      The assessment of safety and tolerability will be an additional objective of this part.~   "
20238|NCT03302065|"~     The purpose of this study is to compare the absorption of four different inhalation products~     with the reference product in healthy volunteers.~   "
20428|NCT03299582|"~     The project is designed to study the use of localized hypothermia alone, or with compression~     to the limbs during chemotherapy infusion for the prevention of chemotherapy induced~     peripheral neuropathy (CIPN). As a pilot study, safety, tolerability and early clinical~     activity will be studied. The study will be conducted on healthy volunteers and cancer~     patients receiving taxane chemotherapy.~   "
20239|NCT03302052|"~     Advance directives are again in the heart of debate since the Leonetti-Claeys's law . These~     pieces of legislation allow everyone to decide by advance their wishes of the end of~     life.However, it does not seem that to legislate on a subject is enough to apply the text of~     law. High authority of health suggest that medical and paramedical staff have to participate~     to the elaboration of the questionnaire and the redaction of advance directives.~      So the aim is that ,before asking patient about their knowledge on these advance directive,~     to evaluate if the staff knows about the law .~   "
20240|NCT03302039|"~     The investigators will compare variable infusion of phenylephrine (at a starting rate of 0.75~     mcg/Kg/min) with fixed rate (0.75 mcg/Kg/min which will stop of reactive hypertension~     occurred) and single shot (1.5 mcg/Kg) phenylephrine.~   "
20241|NCT03302026|"~     This study will examine how real-time functional magnetic resonance imaging (rt-fMRI)~     feedback can be used to modulate brain activation in the context of smoking cues in order to~     resist craving. Participants will complete a total of three fMRI scanning sessions with a cue~     suppression task with or without neurofeedback training (NFT). Participants will be~     randomized to an active group (active NFT) or a control group (no NFT) during the scanning~     sessions. At the end of the third session, all participants will complete a validated smoking~     lapse laboratory paradigm to evaluate effects of NFT on smoking behavior.~   "
20242|NCT03302013|"~     Compare the clinical and patient reported outcomes of the Vanguard XP Knee System to the~     Vanguard CR Knee System in patients with antero-medial osteoarthritis of the knee with an~     intact anterior cruciate ligament.~   "
20243|NCT03302000|"~     Introduction: Prematurity has been more frequent in industrialized countries, which is a risk~     factor for delay in child development. Delays in the development of visual system could be~     highlighted. However, studies that evaluate or stimulate the visual system in preterm infant~     (PT) at an early age and hospitalized in a neonatal unit care (NUC) are scarce.~      Objective: To compare visual acuity of PT and full term (FT) infants. In addition, to verify~     the effect of the early visual stimulation in this population.~      Methods: Non-probabilistic sample of PT assessed at NICU and full-term infants, aged between~     0 and 3 months. A visual acuity assessment will be performed with the ML Leonhardt Battery of~     Optotypes Visual Acuity Cards. Afterwards, a visual stimulation with High Contrast Figures~     will be performed. In addition, a post-stimulation evaluation will be performed with the same~     measure. Also evaluation after 30 days of interventions will be applied with visual acuity~     test and, also, Sensory Profile Scale (SPS) and Alberta Infant Motor Scale (AIMS). The study~     variables will be alertness, attention, fixation, visual tracking, spatial frequency, scores~     of SPS and AIMS. The data will be analyzed according to their distribution of normality. A~     significance level of 5% will be adopted.~   "
20244|NCT03301987|"~     The aim of this study is to evaluate the therapeutic exercise effects in patients with~     chronic kidney disease. An interventional prospective study is carried out. A sample of 9~     patients with chronic kidney disease is recruited. The kidney function (creatinine clearance~     as main outcome) is measured at baseline and 1 month after treatment start.~   "
20245|NCT03301974|"~     Pterygium is a fibrovascular wing shaped encroachment of conjunctival fold on to the cornea~     with elastotic degeneration of a subconjunctival tissue, The standard treatment for pterygium~     is surgical excision, but the recurrence rate after surgery can be as high as 24%-89%, which~     compromises outcomes. Based on the simple excision of pterygium, multiple strategies and~     techniques have been developed to reduce the high rate of pterygium recurrence. The~     investigators aim was to compare the safety, efficacy, overall patient satisfaction and~     recurrence rate of suturing, fibrin gluing and sutureless glue-free technique for attaching~     conjunctival autograft in primary pterygium surgery.~   "
20246|NCT03301961|"~     Lung cancer is the leading cause of cancer-related death in China. This study will explore~     the applications of multiplex analysis of circulating tumor DNA biomarkers for diagnosis and~     surveillance of lung cancer patients~   "
20247|NCT03301948|"~     Healthy male participants are recruited to observe potentially deleterious changes in~     appetite regulation and metabolic control. Participants will be provided with an energy~     intake representative of their daily requirements on the first day of one trial and will be~     provided with an additional 50% energy intake on the first day of another trial. Outcome~     variables will be assessed during the second day of each trial in response to a fixed mixed~     macronutrient meal tolerance test.~   "
20248|NCT03301935|"~     Prospective cohort study including 150 patients with pre-excitation on ECG referred to our~     clinic for risk assessment. There will be equal numbers of symptomatic and asymptomatic~     patients included in the study. Each patient will perform an exercise stress test on bicycle~     before an invasive electrophysiological test. The purpose of this study is to compare~     exercise stress testing on bicycle to an invasive electrophysiological study, regarding risk~     assessment of patients with pre-excitation. The electrophysiology study is set as reference.~   "
20249|NCT03301922|"~     Common mental health disorders such as anxiety and depression are leading causes of sickness~     absence and disability in Norway. Despite tremendous costs for individual and society,~     effective treatment is lacking. Mental health interventions do not typically target work~     situation, despite its importance for patient well-being. On a policy level, effective~     measures are impeded by a paucity of scientific data, and programs designed to address the~     issue such as Faster Return to Work (Raskere tilbake) lack evaluation. The present project~     will test the effectiveness of integrated work-focused metacognitive therapy for reducing~     sick leave in patients with common mental disorders.~   "
20250|NCT03301909|"~     This is a feasibility, prospective, single center, open label, uncontrolled clinical study,~     to evaluate the safety and preliminary efficacy of the different R&D changes made and~     implemented in the existing PillCam Capsule products family, PillCam Endoscopy System~     subunits, the Patency system and bowel preparation procedure.~   "
20271|NCT03301636|"~     This is an adaptive clinical trial that includes a dose escalation phase followed by a~     randomized controlled Phase 3 trial. The purpose of the dose escalation phase is to establish~     the Phase 3 dose of indoximod in combination with pembrolizumab or nivolumab in subjects with~     unresectable or metastatic melanoma and evaluate PK. Subsequently the efficacy, safety and~     tolerability of indoximod plus pembrolizumab or nivolumab versus placebo plus pembrolizumab~     or nivolumab will be studied in subjects with unresectable or metastatic melanoma in the~     Phase 3 portion of the trial.~   "
20251|NCT03301896|"~     The purpose of this trial is to explore the clinical utility of two investigational agents in~     patients with advanced cancer.~      This is a multi-center, open-label Phase I/Ib study. The study consists of four dose~     escalation parts and two dose expansion parts testing LHC165 as a single agent or LHC165 in~     combination with PDR001. The dose escalation parts will estimate the Maximum Tolerated Dose~     (MTD) and/or Recommended Dose for Expansion (RDE) and test two different dosing schedules for~     LHC165.~      The dose expansion parts of the study will use the MTD/RDE for each the LHC165 single agent~     and in combination with PDR001, determined in the respective dose escalation parts to assess~     the activity, safety and tolerability of LHC165 as a single agent or LHC165 in combination~     with PDR001 in patients with specific types of solid tumors.~      Approximately 206 adult patients with advanced solid tumors will be enrolled.~   "
20252|NCT03301883|"~     This Phase IV, multicenter, single-arm, open-label study will evaluate the efficacy and~     safety of tocilizumab in Chinese participants with sJIA with persistent activity and an~     inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs) and steroid therapy.~   "
20253|NCT03301870|"~     This is a Phase I single-site study to evaluate the irritation potential of topically applied~     ATx201 GEL, 2% and 4%, along with positive and negative control and placebo control (ATx201~     GEL Placebo), in healthy human subjects on intact and abraded skin. Approximately thirty-six~     (36) healthy adult subjects will receive all the test articles to provide for 30 subjects to~     complete the study. The test articles will be applied to the upper back of the subjects~     during the study, and the placement of the test articles will be randomized. Abraded skin~     will be induced using sequential tape stripping.~   "
20254|NCT03301857|"~     Study 20140114 will continue to follow subjects with GCTB who were treated in Study 20062004~     and remained on the study at the completion of Study 20062004 for an additional 5 years on~     long-term safety follow up.~   "
20255|NCT03301844|"~     The purpose of this study is to evaluate the efficacy of, and patient satisfaction with~     Blephapad Combo in the treatment of posterior blepharitis.~   "
20256|NCT03301831|"~     Technology-dependent children, those who live at home but rely on medical equipment such as~     mechanical ventilation or feeding tubes, require complex care for their chronic condition.~     Parents usually provide a majority of their care and are often overwhelmed by the caregiving~     demands resulting in deterioration of their own mental and physical health. The goal of this~     2-arm (intervention vs. attention control) RCT is to test a cognitive-behavioral~     Resourcefulness Training intervention that includes teaching social (help-seeking) and~     personal (self-help) resourcefulness skills; ongoing access to video vignettes of caregivers~     of technology-dependent children describing resourcefulness skill application in daily life;~     4 weeks of skills' reinforcement using daily journal writing; weekly phone calls for the~     first 4 weeks; and booster sessions at 2 and 4 months post enrollment. The intervention is~     proposed to improve these caregivers' mental and physical health outcomes and family~     functioning outcomes while they continue to provide vital care for these vulnerable children.~   "
20257|NCT03301818|"~     Female patients with USI will be evaluated for vaginal elasticity using vaginal tactile~     imaging both before and after surgery for the repair of the USI. Surgical repair will be~     performed by a single surgeon who will perform a tension free vaginal tape obturator (TVT-O)~     repair.~   "
20258|NCT03301805|"~     The primary purpose of this study is to determine the safety and recommended dose level (RDL)~     of BLEX 404 Oral Liquid combined with Gemcitabine monotherapy in a 28-day schedule.The~     secondary purpose is to assess the efficacy and safety of BLEX 404 Oral Liquid combined with~     Gemcitabine monotherapy at the recommended dose.~   "
20259|NCT03301792|"~     The investigators primary objective is to conduct a randomized trial to determine the effect~     of diabetes group prenatal care on glycemic control in women with type 2 diabetes and~     gestational diabetes.~   "
20260|NCT03301779|"~     The primary goal of Hemanext. is to improve red cell storage through novel storage methods.~     Based on our review of the pertinent literature, there is substantial evidence suggesting~     that prolonged exposure to oxygen during storage results in oxidative damage to the red blood~     cells leading to decreased therapeutic potential. Therefore, removal of oxygen from red blood~     cell products prior to storage has potential to preserve the cells in a more physiologically~     relevant state.~      Currently, Hemanext has focused on the design and development of a dual compartment bag~     system designated as the Hemanext Red Blood Cell Processing System. After standard processing~     of donated whole blood units into leukoreduced packed red blood cells (LR-RBCs) with the~     appropriate additive solutions, the LR-RBCs would then be placed in the oxygen reduction bag~     (ORB) which allows for the rapid diffusion of oxygen out of the blood, through a sterile,~     oxygen-permeable membrane, and into iron-based oxygen sorbents. After processing, the blood~     is transferred again from the ORB into the Hemanext storage bag (HSB) which will preserve the~     anaerobic state of the LR-RBC product for the duration of cold storage.~      Hemanext has conducted preliminary storage tests to ascertain the effects of anaerobic~     storage on overall blood health in various storage solutions. The research team has focused~     primarily on percent hemolysis, which is mandated by the FDA to remain below 1% for the~     duration of storage, as well as ATP and 2,3-DPG levels.~   "
20261|NCT03301766|"~     This study will evaluate the addition of lidocaine % transdermal patches to standard therapy~     in the treatment of acute non-radicular low back pain in patients discharged from the~     Emergency Department. In addition to standard therapy, half of the participants will receive~     medicated patches while the other half will receive non-medicated patches.~   "
20283|NCT03301480|"~     This study will evaluate the impact of hormonal contraceptives on HIV risk associated with~     changes to the innate immunity in the female genital tract in a cross-sectional study. HIV~     risk will be evaluated by the capacity of cervical tissue to replicate HIV when challenged ex~     vivo and correlated to the number of CD4 T cells, DCs, and macrophages; the capacity of~     cervicovaginal fluid to inhibit HIV will be correlated to soluble mucosal mediators, and the~     vaginal microbiota. The lower genital tract samples will be collected from 120 adolescents~     aged 18-19 (40 using no hormonal contraception, 40 using ENG-I, 40 using LNG-IUS). For~     comparison, 90 adult women aged 25-45 will be equally distributed between the same groupings.~   "
20284|NCT03301467|"~     The aim of this trial is to evaluate the effect of avacopan treatment on renal disease~     activity in patients with complement component 3 glomerulopathy (C3G).~   "
20262|NCT03301753|"~     Today the majority of pregnant women in the United States are either overweight or obese at~     conception with their offspring having greater adiposity at birth, a 2-fold greater risk of~     later obesity, and neonatal insulin resistance. It was long thought that breast milk~     composition was fairly uniform among women, having been optimized through evolutionary time~     to provide adequate sole nutrition for the growing infant regardless of the environmental~     circumstances. However, recent evidence shows that breast milk is a highly complex fluid with~     significant inter-individual variation in hormonal and cytokine concentrations. Pervasive~     maternal obesity is an evolutionarily novel condition for the human species but little effort~     has yet been made to systematically examine how this novel condition is associated with~     breast milk adipose-tissue derived hormone and cytokine (adipocytokine) variation, or whether~     that variation relates to infant metabolic status. The objective of this study is to~     comprehensively assess the lactational programming hypothesis, that is, whether or not~     recently documented variation in breast-milk composition is related to both maternal~     adiposity and to infant metabolic status. The central hypothesis is that a graded,~     dose-response relationship between maternal adiposity and adipocytokine concentrations in~     breast milk exists and that milk adipocytokine concentrations are associated with altered~     body composition in their exclusively breast-fed offspring. The results of the study will be~     used to design interventions to reduce maternal weight during pregnancy and lactation and to~     augment lactation education materials to focus on the needs of obese breast-feeding women.~   "
20263|NCT03301740|"~     The rate of fluid removal (ultrafiltration, UF) during hemodialysis (HD) may contribute to~     cardiovascular morbidity and mortality among individuals receiving maintenance HD. More rapid~     UF rates are associated with higher morbidity and mortality. Ultrafiltration profiling, the~     practice of varying UF rates to maximize fluid removal during periods of greatest hydration~     and plasma oncotic pressures, is one treatment modification that may reduce UF-related harm~     without necessitating reduction in interdialytic fluid intake or longer HD treatments. To~     date, UF profiling has not been adequately studied independent of sodium profiling.~      This study investigates the comparative effect of UF profiling versus non-profiled~     conventional HD on select cardiovascular and patient-reported outcomes. Participants will~     complete two phases of UF profiling and two phases of conventional HD and will act as their~     own controls.~   "
20264|NCT03301727|"~     Cognitive-behavioural therapy for insomnia (CBT-I) has been shown to be an effective~     treatment for insomnia in multiple populations, including women during pregnancy and~     postpartum. Online CBT-I has also been shown to be effective and comparable to in-person~     CBT-I, and shows promise as an accessible treatment alternative to in-person CBT-I for~     pregnant women experiencing insomnia. As the harmful consequences of insomnia or sleep~     disturbances have been well documented during late pregnancy, this randomized-controlled~     trial will compare the efficacy of both in-person and online CBT-I on pregnant women with~     insomnia to a wait-list control group.~   "
20265|NCT03301714|"~     The study aims to assess the efficacy of an oral health education group based activity versus~     an individual based oral health education activity in terms of changes in oral health related~     quality of life (OHRQoL), self-efficacy and oral health knowledge.~   "
20266|NCT03301701|"~     Patients with hormone sensitive oligometastatic prostate cancer (≤ 5 metastatic tumours~     outside of regional pelvic nodes with no more than 3 in any organ system) and no previous~     treatment to prostate will be treated with intermittent androgen deprivation therapy +/-~     chemotherapy, stereotactic radiotherapy to all metastases, and either radical prostatectomy~     or radiotherapy.~   "
20267|NCT03301688|"~     This study was designed to evaluate the similarity of single-dose and parallel comparisons of~     recombinant humanized anti-PD-1 monoclonal antibody injections before and after process~     changes. It is designed to be a single-center, open and parallel controlled phase I study.~     Patients with advanced NSCLC will be enrolled.~      After determining that the patient is qualified, the patient will be assigned to a batch of~     drug use in the order in which they are selected. The dosage of drug was set at 3 mg / kg.~     Planned to recruit subjects each 12 patients (24 cases) to participate in this study, taking~     into account a 20% dropout rate, so that the total of 15 patients (30 patients) subjects in~     each group in this study.~      This study was divided into study phase (single-dose period) and follow-up stage~     (multiple-dose period).Each subject first conducted a single dose safety and pharmacokinetics~     (PK) study.If the subject did not develop adverse events that had significant clinical~     significance as suggested by the investigators within 28 days of the single dose and~     continued reorganization of the humanized anti-PD-1 monoclonal antibody injection to benefit~     the patient , and with the agreement of subjects, the subject will enter the follow-up phase~     (multiple-dose period). The same dose of recombinant humanized anti-PD-1 monoclonal antibody~     injection was administered once every 2 weeks and 4 consecutive cycles of treatment for one~     cycle of continuous period.Until the patient has developed tumor progression or an~     untolerated toxic side effect, the patient voluntarily exits the study or believes that the~     situation is not suitable for continuing treatment. There are follow-up of 90 days after~     treatment.~   "
20268|NCT03301675|"~     This study aimed to verify if combination of a healthy diet and orange juice consumption can~     minimize cardiometabolic risk factors for Metabolic Syndrome (MetS)~   "
20269|NCT03301662|"~     In stroke survivors, atrial fibrillation is typically detected with short-term~     electrocardiogram (ECG) monitoring in the stroke unit. Prolonged continuous ECG monitoring is~     impractical and requires substantial resources while insertable cardiac monitors are invasive~     and costly. Chest and thumb-ECG could provide an alternative for atrial fibrillation~     detection post-stroke.~      The primary objective of our study is to assess the incidence of newly diagnosed atrial~     fibrillation during 28 days of chest and thumb-ECG monitoring in patients with cryptogenic~     stroke. Secondary objectives are to assess Health-related Quality of Life using Short Form-36~     and the feasibility of the Coala Heart Monitor in patients with stroke.~   "
20270|NCT03301649|"~     A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study~     to Evaluate the Therapeutic Equivalence and Safety of Ivermectin Lotion 0.5% (Actavis~     Laboratories UT, Inc.) to SKLICE® (ivermectin) Lotion, 0.5% (Arbor Pharmaceuticals, LLC) in~     the Treatment of Human Head Lice Infestation~   "
28199|NCT03197883|"~     To evaluate the local tolerance and cosmetic efficacy of a topical skin care formulation in~     healthy female participants with mild to advanced photo-damaged facial skin who have~     undergone a 70% Glycolic Acid facial peel procedure.~   "
20272|NCT03301623|"~     Investigators will compare Clinical Decision Support (CDS) versus Patient Education and~     Activation Tools (PEATs) in patients with an opioid prescription of six weeks or longer to~     measure outcomes that are important to patients. Primary outcomes are pain interference and~     satisfaction with patient-physician communication. Secondary outcomes are overall~     Health-Related Quality of Life and high-risk prescribing, including prescriptions over 90~     morphine milligram equivalents and coprescribing of benzodiazepines and opioids.~      Patients in the PEAT arm will receive patient materials during the intervention, developed to~     engage patients in chronic pain treatment, prior to Primary Care Physician office visits. In~     the provider-facing CDS arm, PCPs will receive computerized reminders about appropriate~     opioid use during office visits for enrolled patients. Patients in both groups will receive~     questionnaires about pain interference, quality of life, and physician-patient communication~     through the patient portal one month after each visit to their Primary Care Physician.~     Investigators will use multi-level regression models to compare the effectiveness of these~     two communication strategies.~   "
20273|NCT03301610|"~     The purpose of this study is to explore the clinical impact of pain management education~     using a mobile web-based education delivery system compared to standard education delivery.~     This study seeks to understand the difference between two different education delivery~     methodologies and the effect on the postoperative pain experience, including participation in~     treatment plan, knowledge, pain outcomes, and opioid requirements in patients undergoing~     major hip (THA) and knee (TKA) arthroplasty. It is hypothesized that a real-time,~     interactive, mobile education system will demonstrate improved pain associated outcomes and~     higher patient participation when compared to the current standard education delivery method.~   "
20274|NCT03301597|"~     Phase 2 open-label, multi-center, randomized, controlled, dose-finding study of safety and~     efficacy of NLA101 to reduce the rate of infections associated with CIN in adult subjects~     with AML.~   "
20275|NCT03301584|"~     Background Studies have shown that patients with hip fracture treated in a Comprehensive~     Geriatric Care (CGC) unit report better results in comparison to orthopaedic care.~     Furthermore, involving patients in their healthcare by encouraging patient participation can~     result in better quality of care and improved outcomes. To our knowledge no study has been~     performed comparing rehabilitation programmes within a CGC unit during the acute phase after~     hip fracture with focus on improving patients' perceived participation and subsequent effect~     on patients' function.~      Method A prospective, controlled, intervention performed in a Comprehensive Geriatric Care~     (CGC) unit and compared with standard CGC. A total of 126 patients with hip fracture were~     recruited who were prior to fracture; community dwelling, mobile indoors and independent in~     personal care. Intervention Group (IG): 63 patients, mean age 82.0 years and Control Group~     (CG): 63 patients mean age 80.5 years. Intervention: coordinated rehabilitation programme~     with early onset of patient participation and intensified occupational therapy and~     physiotherapy after hip fracture surgery. The primary outcome measure was self-reported~     patient participation at discharge. Secondary outcome measures were: TLS-BasicADL; Bergs~     Balance Scale (BBS); Falls Efficacy Scale FES(S); Short Physical Performance Battery (SPPB)~     and Timed Up and Go (TUG) at discharge and 1 month and ADL staircase for instrumental ADL at~     1 month.~   "
20276|NCT03301571|"~     Postoperative right ventricular (RV) dysfunction increases mortality and risk of cardiac~     failure after cardiac surgery substantially. A comprehensive understanding of this condition~     is paramount in order to achieve success in treatment and early diagnosis.~      This study has two main aims.~      Perioperative aim:~      To investigate correlations between changes in echocardiographic measurements and hemodynamic~     changes at baseline and following coronary artery bypass graft (CABG) surgery.~      Postoperative aim:~      To evaluate changes in haemodynamics and echocardiographic parameters during separate~     physiological interventions (increase in preload/afterload, oxygen fraction, pacing modes~     (AAI/DDD/VVI)).~   "
20277|NCT03301558|"~     This is a single-center, prospective, open-label, randomized, cross-over study.~   "
20278|NCT03301545|"~     Obesity and type 2 diabetes mellitus (T2DM) are major global health concerns as they commonly~     co-occur and are associated with significant morbidity, mortality, and health care~     expenditures. The Indigenous (First Nations, Metis and Inuit) population bears a~     disproportionate burden of T2DM in Canada. The prevalence of obesity among Indigenous~     individuals is approximately 31.2% compared to 18.6% for the non-Indigenous population. In~     2011, 16.7% of Manitoba's population, or four times the Canadian average, identified as~     Indigenous. At the same time, prevalence of T2DM in Manitoba is on the rise. Bariatric~     surgery is an effective treatment modality for the improvement and resolution of T2DM in~     patients who are obese. We aim to compare the effectiveness of bariatric surgery with~     conventional medical treatment in treating metabolic diseases in Indigenous people; the~     findings of which will assist in future treatment and program planning. Our objective is to~     determine whether Manitoba's urban Indigenous population will achieve better diabetic control~     and improved rates of remission of T2DM with bariatric surgery compared to best diabetic~     medical care.~   "
20279|NCT03301532|"~     To explore triheptanoin (C7 oil) compatibility with the ketogenic diet by evaluating EEG, and~     seizure rate, glycemia and ketosis in proven G1D patients receiving a ketogenic diet.~   "
20280|NCT03301519|"~     This is a family based genotype-phenotype study designed to assess genetic and environmental~     influences on obesity, insulin resistance and beta cell function in the context of~     gestational diabetes.~   "
20281|NCT03301506|"~     An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in~     Subjects with Primary Biliary Cholangitis (PBC)~   "
20282|NCT03301493|"~     There is no evidence available about which molecular profiling methods are currently used for~     cancer patients in Austrian clinical practice. The construction of the registry proposed as a~     completely independent research endeavor, will be helpful for scientific evaluation and the~     establishment of highly credible data.~   "
20285|NCT03301454|"~     Phase II study, randomized, open-label, multicentric, willing to establish the benefit of~     pursuing chemotherapy beyond 6 weeks for non progressive patients. The study will proceed in~     two successive phases :~        -  non randomized phase in which all patients will undergo chemotherapy~        -  second phase in which only non progressive patients are going to be randomized~          (discontinuation design). Patients that will show progression in their disease during~          the first 6 weeks will be released of the study~   "
20288|NCT03301415|"~     This is a phase II, open-label trial to evaluate valganciclovir as a treatment to prevent~     development of SNHL in infants with asymptomatic congenital CMV infection. The trial will be~     conducted in two phases - screening of newborns to identify eligible subjects, and treatment~     of those newborns who have confirmed CMV infection at birth but without outward~     manifestations of congenital CMV infection. 229 newborns with confirmed CMV infection but~     without baseline SNHL and who meet all inclusion/exclusion criteria will be enrolled into the~     treatment phase. Study duration is 5 years. Primary objective of this study is to estimate~     the proportion of subjects with asymptomatic congenital CMV infection who, following~     treatment with 4 months of oral valganciclovir, develop sensorineural hearing loss (SNHL) by~     6 months of life.~   "
20289|NCT03301402|"~     Background: There is epidemiological evidence or link ambient air pollution exposure to the~     incidence of dementia.~      Aims or hypotheses: It is hypothesized that reduction in indoor pollutants from air~     purification improves endothelial function and carotid intima thickness in older diabetic~     people with cognitive impairment.~      Subjects and method: People with clinically diagnosis mild cognitive impairment or early~     dementia will be recruited. After obtaining written consent, the subjects will be assessed~     cognitive function and arterial health. After baseline measurements, the subjects are~     randomly assigned to have either filter or no filter installed in the air purifier. The air~     purifier will be placed in living room of the household of the subject for one year. At one~     year, the measurements will be repeated.~      Statistical analysis: Intention to treat analysis will be adopted.~   "
20290|NCT03301389|"~     Chemotherapy or radiation therapy-induced cardiotoxicity are well-recognized side effects in~     patients with cancer. The clinical significance of cardiotoxicity is growing with increasing~     cancer survivor-ship.~      Left ventricular (LV) functional assessment is the standard of reference to diagnose~     chemotherapy- or radiation therapy-induced cardiotoxicity. The investigators will investigate~     the usefulness of T1 mapping parameters for early detection and prediction of chemotherapy-,~     radiation therapy-, or other therapy-induced cardiotoxicity in breast cancer patients This~     study aimed to achieve early detection of chemotherapy- or radiation therapy-induced~     cardiotoxicity using T1 mapping magnetic resonance imaging (MRI) and determine a prognostic~     imaging factor of chemotherapy- or radiation therapy-induced cardiotoxicity in patients~     treated for breast cancer.~   "
20291|NCT03301376|"~     Severe haemophilia and subsequent arthropathy result in joint pain, disability and impaired~     health-related quality of life. Improvements in haemophilia care over the last decades might~     lead to expectation of a near-normal quality of life for adults with haemophilia. However,~     little is known about the impact of haemophilia and its treatment on social functioning. A~     study based on a national US cohort of 141 young men (18-34 y.o.) showed that, compared to~     the general US population, this cohort experienced social burdens such as unemployment and~     lower high-school graduation rates. Another study conducted in the framework of the HERO~     (Haemophilia Experiences, Results and Opportunities) international initiative showed that a~     majority of the 230 young adults aged 18-30 years (including 16 French participants) were~     employed at least part-time (62%) and most of them reported that haemophilia has had a~     negative impact on employment (76%) which was reported as moderate or very large by 47% of~     the participants. The replicability of these results could be limited by the specific~     socio-economic national context. In France, a survey was conducted in 2008 to assess quality~     of life and its determinants in children, adolescents and adults with moderate and severe~     haemophilia. Descriptive results on the socio-economic characteristics of the included adults~     showed that 51.3% of them had access to higher education (which was higher than the observed~     rate in the French general population in 2005, i.e. 32.5%), and that 52.1% were employed~     among whom 44.3% had an at-risk activity. In spite of these results which were presented in a~     descriptive report by the InVS (Institut de veille sanitaire - French Institute for Public~     Health Surveillance), some limitations could be discussed:~   "
20292|NCT03301363|"~     The purpose of this study is to compare electrical acute changes between simultaneous and~     sequential LV pacing and to assess the paced QRSd over a range of inter- and~     intra-ventricular programmable delays setting during MPP pacing.~   "
20293|NCT03301350|"~     This is a phase II single-arm, open-label, prospective study to evaluate the efficacy of the~     low dose weekly Carboplatin/Paclitaxel followed by dose-dense Doxorubicin/Cyclophosphamide in~     subjects with triple-negative breast cancer in neoadjuvant settings.~   "
20294|NCT03301337|"~     The purpose of the project is to provide evidence for the use of hydrolysed meat protein~     (HMP) as a protein supplement for elderly who has difficulty meeting the recommended daily~     protein intake.~      The study will investigate how the meat protein derived amino acids (from either HMP, steak~     or minced meat) are absorbed and released into the blood circulation of elderly persons.~     Hereby, the study will explore the the anabolic potential of HMP compared with common meat~     products.~   "
20295|NCT03301324|"~     The Intubation Assist Clinical Study is an observational study of adult patients scheduled~     for elective surgery under general anesthesia to assess the user interface, assess~     transthoracic impedance by the ventilation volume and assess transthoracic impedance.~     Monitoring will begin at the time the patient is pre-oxygenated in preparation for~     endotracheal intubation and will continue until 30 minutes after intubation is achieved.~   "
20296|NCT03301311|"~     A series of N-of-1 trials will be used to determine the effectiveness of a specific~     carbohydrate diet (SCD) versus a modified SCD in patients in reducing symptoms and~     inflammatory burden at both the individual and population level. This is a three-year study.~     The study staff will recruit 120 patients (goal sample size of 100, accounting for attrition)~     across up to 12 sites in patients aged 7-17 with mild to moderate disease activity.~   "
20297|NCT03301298|"~     This is a randomized, double-blind, placebo-controlled, single ascending oral dose and food~     effect study conducted at one study center in the United States. Safety and tolerability will~     be assessed throughout the study and serial blood samples and urine samples will be collected~     for the safety and pharmacokinetic assessment of SXC-2023.~   "
20429|NCT03299569|"~     Acute stress-induced (Tako-tsubo) cardiomyopathy presents like a heart attack and is~     triggered by intense emotional or physical stress. Although heart arteries are unobstructed,~     the risk of death is similar to a heart attack. The purpose of the STARR study is to identify~     all cases of Tako-tsubo in Scotland since 2010.~   "
20298|NCT03301285|"~     The main purpose of this study is the evaluation of the efficacy of zoledronic acid on bone~     density in children with osteoporosis caused by multiple disabilities.~      Secondary purposes are:~        1. Description of child population with osteoporosis in the context of motor impairment in~          Lorraine region~        2. Description of osteoporosis stage (level of bone mineralization and clinical~          consequences) in children with multiple disabilities~        3. Description of current osteoporosis preventive care~        4. Description of risk factors associated to bone status (drugs)~        5. Evaluation of zoledronic acid treatment on fracture numbers~        6. Evaluation of zoledronic acid on phosphocalcic profile~        7. Description of side effects of zoledronic acid in this indication~        8. Description of treatment effects in the sub-population of children with Rett syndrome.~   "
20299|NCT03301272|"~     Purpose: Rest tremor in Parkinson's disease is notoriously difficult to treat through~     pharmacological measures, currently only predictably attenuated by the invasive deep brain~     stimulation surgery. We hope to find some predictable and clinically meaningful attenuation~     of tremor with targeted use of onabotulinum toxin on muscles involved in creating the tremor.~      Participants: 16 subjects who meet UK brain bank criteria for Parkinson's disease with~     medically refractory rest tremor of at least 3 cm amplitude.~      Procedures (methods): Subjects will be blinded to receive either sham saline injection versus~     onabotulinum toxin injections directed to muscle groups felt to be clinically involved in~     causing the oscillatory movement of the tremor. Assessment of tremor severity and functional~     improvement from baseline after injection will occur within group (i.e. each subject will~     serve as their own control).~      Hypotheses:~      1. (A) Onabotulinumtoxin A significantly attenuates the amplitude of medically-refractory~     rest tremor of the upper limb in Parkinson's patients as compared to sham injections; as~     measured by reduction in the MDS-UPDRS tremor subscore.~      1. (B) Onabotulinumtoxin A significantly improves the limb function of Parkinson's patients~     with medically-refractory rest tremor of the upper limb as compared to sham injections; as~     measured by an increase in ARAT scores.~   "
20300|NCT03301259|"~     The aim of this study is to evaluate the post treatment pain after instrumentation of root~     canals with a single file reciprocating (Wave-One Ni Ti file, DENTSPLY Maillefer) or~     rotary(One Shape, Micro Mega, France) file system in patient with asymptomatic necrotic~     molars This trial will help to clinically evaluate the use of reciprocating motion in~     endodontic treatment in necrotic teeth without periapical lesion therefore reduce the~     post-obtuation pain~   "
20301|NCT03301246|"~     This is a prospective, non-randomized, open label, multi-center study including 60 patients~     with symptomatic ischemic heart disease with 70%-100% coronary artery stenoses and occlusions~     enrolled and treated in this investigational device study.~   "
20302|NCT03301233|"~     The endometrium is a dynamic tissue that responds to changing hormonal signals throughout the~     cycle. The changes in the endometrial composition are expressed in alteration in gene~     expression, micro architectural morphological changes as well as in protein and hormone~     secretion. These factors combine together to construct the window of implantation a short~     period of time during the luteal phase in which the endometrium is receptive.~      Thin endometrium is associated with a low pregnancy rate. Endometrial thickness 7 mm in the~     pre-ovulatory phase is widely accepted to be cut-off of thin endometrium.~      for that the aim of this study is to compare the effect of sildenafil-estrogen combination to~     estrogen alone on endometrium thickness in infertile women. Half of the patients will receive~     estrogen ( estradiol valerate ) and the other half will receive combination of~     sildenafil-estrogen .~   "
20303|NCT03301220|"~     The primary objective of this study is to determine whether treatment with daratumumab~     administered subcutaneously (SC) prolongs progression-free survival (PFS) compared with~     active monitoring in participants with high-risk smoldering multiple myeloma (SMM).~   "
20304|NCT03301207|"~     The main purpose of this study is to evaluate the effects of repeat dosing of ibrutinib on~     the single-dose pharmacokinetics (PK) of oral contraceptives (OC - ethinylestradiol [EE] and~     levonorgestrel [LN]), the cytochrome P450 (CYP)2B6 probe bupropion and the CYP3A4 probe~     midazolam; and to evaluate the effects of single-dose ibrutinib on the single-dose PK of the~     CYP3A4 probe midazolam in female participants with B cell malignancy.~   "
20305|NCT03301194|"~     Hypertension (HT) is an important risk factor for stroke, coronary heart disease (CHD), heart~     failure and renal diseases, and the leading risk factor of global disease burden. A multitude~     of interventions have proven efficacy in lowering blood pressure and reducing long term HT~     complications, including pharmacologic treatment, DASH diet (Dietary Approaches to Stop~     Hypertension), exercise, weight reduction, smoking cessation, alcohol moderation and~     self-monitoring of blood pressure.~      Objectives:~      To evaluate long-term effectiveness and cost-effectiveness of~     Risk-Assessment-and-Management-Programme-for-Hypertension (RAMP-HT), a multi-disciplinary~     structured service to enhance quality of hypertension care in primary care compared to usual~     care~      Hypotheses:~        1. RAMP-HT is effective in reducing HT complications, based on previous results showing~          RAMP-HT was effective in improving patients' blood pressure~        2. RAMP-HT is cost-effective~      Design and Subjects:~      Retrospective study of 5-year longitudinal data on matched cohorts of public primary care~     patients with uncontrolled HT under RAMP-HT and usual care will be conducted to evaluate~     long-term effectiveness and direct medical costs. Results from the long-term effectiveness~     and costing analyses will be applied to Markov modeling to determine the life time~     cost-effectiveness of RAMP-HT.~      Main outcome measures:~        1. 5-year incidence of cardiovascular complications~        2. Direct medical costs of RAMP-HT and usual care HT patients~        3. Incremental cost-effectiveness ratio (ICER) of cost per quality-adjusted life year~          (QALY) gained by RAMP-HT compared to usual care~      Data analysis:~      Cox regression will be performed to estimate the effect of RAMP-HT on the development of HT~     complication adjusted for baseline covariates. Descriptive statistics will be used to~     calculate costs of RAMP-HT and annual direct medical costs for HT patients. Markov modeling~     will be used to simulate 2 patient cohorts (RAMP-HT versus usual care) to estimate the~     respective lifetime direct medical costs and QALY gained/person. Cost/QALY of RAMP-HT will be~     compared to that of usual care to determine the ICER.~      Expected results:~      The results can provide evidence on the effectiveness and cost-effectiveness of RAMP-HT for~     primary care patients with uncontrolled HT, which can inform health policy and service~     planning.~   "
20306|NCT03301181|"~     Phase 1 study in healthy subjects to determine the effect of rifampin (Part A) or~     itraconazole (Part B) on the pharmacokinetics of BGB-3111~   "
20307|NCT03301168|"~     This study will evaluate pediatric patients with malignant or non-malignant blood cell~     disorders who are having a blood stem cell transplant depleted of T cell receptor (TCR) alfa~     and beta cells that comes from a partially matched family donor. The study will assess~     whether immune cells, called T cells, from the family donor, that are specially grown in the~     laboratory and given back to the patient along with the stem cell transplant can help the~     immune system recover faster after transplant. As a safety measure these T cells have been~     programmed with a self-destruct switch so that they can be destroyed if they start to react~     against tissues (Graft versus host disease).~   "
28200|NCT03197870|"~     The purpose of this study is to evaluate the safety and efficacy of subcutaneously~     administered AKB-9778 15mg once daily or 15mg twice daily for 12 months in patients with~     moderate to severe non-proliferative diabetic retinopathy (NPDR).~   "
20308|NCT03301155|"~     The purpose of this study is to obtain additional data on efficacy and safety of 12-week~     course of therapy with Anaferon for children for prevention of influenza and other acute~     respiratory viral infections in children during the peaks of seasonal morbidity.~      Primary objectives of the study:~        1. To assess duration of the period from the first dose of the drug until manifestation of~          the symptoms of influenza or another acute respiratory viral infection (ARVI) in two~          groups of subjects receiving preventive therapy with the study drug (Anaferon for~          children) or Placebo.~        2. To compare duration of periods from the first dose of the drug until manifestation of~          the symptoms of influenza or another ARVI in two groups of subjects (Anaferon for~          children and Placebo).~        3. Based on the comparison of duration of periods from the first dose of the drug until~          manifestation of the symptoms of the disease in these two groups, to assess efficacy of~          Anaferon for children for prevention of influenza and other ARVI in children during the~          peaks of seasonal morbidity and demonstrate superiority of the study drug over placebo.~      Additional study objectives:~        1. To assess and compare percentage of children not falling with influenza or another ARVI~          in the two groups during 4-, 8- and 12-week course of preventive therapy.~        2. To assess and compare percentage of children in the two groups with the symptoms of~          respiratory or ear-nose-throat bacterial infections requiring antibacterial therapy~          within 12-week preventive therapy.~        3. To assess and compare percentage of children hospitalized with influenza/ARVI or their~          complications in the two groups within 12-week preventive therapy.~        4. Based on collection and analysis of adverse events during the therapy, to obtain~          additional information on safety of the study drug~   "
20309|NCT03301142|"~     The purpose of this study is compare the effect of laser and of kinesiotherapy in the~     treatment of women with stress urinary incontinence~   "
20310|NCT03301129|"~     Electronic cigarettes (E-cigarettes) and new heat-not-burn tobacco products such as IQOS®, an~     electronic device that heats a cigarette-like stick without combustion, are a modern and~     technological surrogate of traditional tobacco cigarettes (T-cigarettes), that are entering~     in the commercial market. While the negative effects of the traditional cigarette are well~     known, little data are reported in scientific literature on the risks on the health by these~     new smoking devices. Endothelial dysfunction evaluated by flow-mediated dilatation (FMD),~     oxidative stress and platelet activation have been recognized as a hallmark of preclinical~     systemic atherosclerosis and as a useful marker to stratify the risk of cardiovascular~     disease in patients at risk or with established clinically significant atherosclerosis. Since~     no data are reported about the effects of these new smoking device on oxidative stress,~     platelet activation and FMD, the investigators designed a human study assessing if these new~     smoking devices have effects on healthy smokers.~   "
20311|NCT03301116|"~     This study aims to test whether a safe physical activity program with a built-in motivational~     enhancement component, performed in a seated position, preserves the function and well-being~     of older home care clients.~   "
20312|NCT03301103|"~     The APA12/PANTER study is a parallel 3-weeks intervention study. Subjects will be randomly~     assigned to one of two treatment groups; placebo or PTM202 (n=36 per group). After an~     overnight fast, subjects will be orally infected with a live, but attenuated, diarrheagenic~     E. coli at study day 14. At various time points before and after diarrheagenic E. coli~     challenge an online diary will be kept to record information on stool consistency, frequency~     and severity of symptoms and stool samples will be collected to determine total fecal wet~     weight and percentage of fecal wet weight.~   "
20313|NCT03301090|"~     This is a Phase 1, first-in-human (FIH), single site, randomized, double-blind,~     placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and~     immunogenicity of single ascending doses of a co-administered (1:1, w/w) combination of~     REGN3048 and REGN3051 mAb's, administered IV in healthy adult volunteers. Study duration of~     approximately 16 months. Approximately 48 evaluable subjects will be enrolled in the study,~     eight (8) subjects in each one of 6 sequential ascending IV dose cohorts. In each cohort,~     subjects will be randomized to receive mAb's REGN3048 and REGN3051 (6 subjects) or placebo (2~     subjects). Primary Objective: To assess the safety and tolerability of REGN3048 and REGN3051~     following co-administration of single, ascending IV doses of 1.5, 5, 15, 25, 50, and 75 mg/kg~     of each of the two mAb's.~   "
20314|NCT03301077|"~     The purpose of the Mental Health in Austrian Teenagers (MHAT) - Study is to collect the first~     epidemiological data on mental health and psychiatric disorders in a representative sample of~     Austrian adolescents between 10 and 18 years.~   "
20315|NCT03301064|"~     Latinos will comprise nearly 30% of the population by 2050, and socially disadvantaged~     Latinos experience a greater burden of poor health and negative social consequences related~     to their alcohol use than non-Latino Whites. Despite the need for services, low treatment~     utilization rates and poor treatment retention suggest it is important to make alcohol~     interventions more accessible for Latinos. Community health workers are an effective way to~     help under-served populations manage chronic illnesses such as diabetes and hypertension, but~     they have been used very little in addiction services. The current study extends work from a~     pilot study that utilized community health workers to deliver a brief alcohol intervention~     that integrates Motivational Enhancement Therapy and Strengths-Based Case Management~     (MET/SBCM). Based on those promising but preliminary findings, this study will test the~     MET/SBCM intervention among a broader population of socially disadvantaged Latinos who engage~     in unhealthy drinking. For the study a partnership will be formed between the University of~     California, Los Angeles (UCLA) and a large community-based healthcare organization,~     Providence Center for Community Health Improvement to conduct a randomized controlled trial~     of the MET/SBCM intervention.~      Participants (n=260) will screen positive for exceeding US low-risk drinking guidelines and~     will not be seeking alcohol treatment. They will be randomized to either the 3-session~     MET/SBCM alcohol intervention or to an alcohol brochure control condition. Alcohol use,~     alcohol-related problems and utilization of health and social services will be assessed at~     baseline, 3-, 6- and 12-month follow-ups. It is predicted that the MET/SBCM intervention will~     improve outcomes compared to the control group. The study will also examine the extent to~     which changes in drinking were preceded by improvements in readiness to change, perceived~     benefits and risks associated with alcohol use, perception of drinking norms, use of~     pro-change language during intervention sessions, belief in one's ability to change,~     self-esteem and use of community services.~      The goal of this project is to establish an evidence base for an intervention approach that~     is sustainable by a large community-based organization serving Latinos. Working with~     community health workers poises this intervention to address health disparities within this~     community. The project will help improve the reach and impact of effective alcohol~     interventions among socially disadvantaged Latinos, thereby contributing to improved~     population health.~   "
20316|NCT03301051|"~     This Phase 3 study is intended to assess the efficacy of the Quadrivalent VLP Influenza~     Vaccine during the 2017-2018 influenza season in healthy adults 18 to 64 years of age. One~     dose of Quadrivalent Virus-Like Particles (VLP) Influenza Vaccine (30 μg/strain) or of~     placebo will be administered to approximately 10,000 subjects.~   "
20317|NCT03301038|"~     This study evaluates the efficacy of rifampin in the treatment of hypercalcemia and/or~     hypercalciuria in participants with biallelic inactivating mutations of the CYP24A1 gene.~     Eligible subjects will receive rifampin for a total of 16 weeks during this study.~   "
20318|NCT03301025|"~     Elective lumbar spine surgical procedures are commonly performed under controlled hypotension~     during general anesthesia. That is beneficial to limit the intraoperative blood loss and~     transfusions and improves surgical field. Deliberate hypotension could be achieved via~     various medications but mostly associated with significant side effects. Pregabalin~     effectively augmented hypotensive anesthesia. The hypothesis is that Pregabalin 150 mg single~     preoperative dose may augment intraoperative deliberate hypotension that will be reflected on~     blood loss and nitroglycerin consumption.~   "
23420|NCT03260426|"~     Prospective randomized controlled trial investigating commencement of low residue diet versus~     clear liquids on postoperative zero following elective colorectal surgery, with regards to~     patient tolerability, incidence of nausea and/or vomiting, and postoperative length of~     hospitalization stay.~   "
20319|NCT03301012|"~     At discharge from outpatient treatment, researchers will recruit 300 adolescents and randomly~     assign them to recovery support as usual control condition or the Smartphone Addiction~     Recovery Coach for Adolescents (SARC-A) experimental condition. Participants in the~     experimental conditions will receive a smartphone, a calling/texting/data plan, and the~     SARC-A mobile applications for the first 6 months post treatment discharge. Experimental~     participants will 1) complete a 2-3 minute recovery-focused ecological momentary assessment~     (EMA) at 5 random times a day, receive feedback on their current answers, and provided access~     to behavioral charting of their past answers over time; and 2) receive continuous access to a~     suite of self-initiated ecological momentary interventions (EMI) to support their recovery~     via tool box of coping tools, apps related to getting support, and apps related to~     maintaining a healthy lifestyle. Data include standardized assessments, urine tests, mobile~     phone metadata, EMA responses, and EMI utilization. The study's primary aim and hypothesis~     are:~      Aim 1: Test the effects of experimental assignment on the frequency of substance use.~      H1 Relative to the control group, participants in the experimental group will have lower~     scores on the quarterly Substance Frequency Scale (3, 6, 9 months post- discharge).~   "
20320|NCT03300999|"~     The purpose of our graduate student research study is to observe the effect of drinking~     ginger tea daily on period discomfort.~   "
20321|NCT03300986|"~     This study aims to look at how changes to a person's functional electrical stimulation might~     change how they walk. Functional electrical stimulation (FES) is commonly used to help people~     with foot drop from upper motor neurone conditions such as stroke or multiple sclerosis. This~     group of people have muscle weakness which makes it difficult to lift the foot, which causes~     trips and falls.~      FES reduces foot drop by using a portable device to apply short electrical pulses to the~     nerve which lifts the foot. The FES device stimulates this nerve only during the swing phase,~     when the foot is off the floor. Typically this is achieved by using a foot-switch, which~     detects when the heel leaves the floor. Stimulation begins a short interval of time after the~     heel leaves the floor, ramps up from zero to set stimulation for the individual, and at~     another period of time after the heel hits the floor, stimulation ramps down from set amount~     to zero. There are four time intervals described here which can be varied by the clinician on~     the device:-~        -  Delay (the time between heel lift and the start of stimulation)~        -  Ramp up (the time for stimulation to reach full strength)~        -  Extension (the time between heel strike and the ramp down)~        -  Ramp down (the time for stimulation to reach zero from full strength) These intervals~          are usually set by experienced clinicians using a qualitative assessment of the~          patient's walking and trial-and-error. A literature review has found no published~          studies which compare walking with different timing. This knowledge would be useful for~          clinicians, who could use this information as a starting point in finding the best~          timing parameters for each patient.~   "
20322|NCT03300973|"~     A trial to answer the debatabal question about the role of urodynamic study in surgical~     treatment for stress urinary incontinence.~   "
20323|NCT03300960|"~     The purpose of this study is to determine whether Medroxyprogesterone Acetate (MPA)~     administration in follicular phase prevents premature luteinization with equal efficiency as~     GnRH antagonists and otains similar clinical results in oocyte donation.~   "
20324|NCT03300947|"~     This study will evaluate whether psilocybin, a hallucinogenic drug, improves symptoms of~     obsessive compulsive disorder (OCD), whether it is safely tolerated as treatment of OCD, and~     will investigate the mechanisms by which it works.~   "
20325|NCT03300934|"~     This study evaluates the use of the FD2 automated closed loop insulin administration in~     Adolescents with a poor metabolic control . All youth will be treated in a random order by~     their usual pump treatment or an Automated system and we will evaluate whether this has an~     impact on metabolic control and sleep~   "
20326|NCT03300921|"~     The main purpose of this study is to look at the potential effects of paricalcitol (a drug~     similar to vitamin D) on pancreatic tumors in patients who are planned for surgical removal~     of their tumor. The study will also look at the safety of paricalcitol prior to surgery.~   "
20327|NCT03300908|"~     The purpose of this study was to pilot test the potential for improvement in antiretroviral~     medication adherence of a an adapted group-based, multi-session, community-based~     Antiretroviral Therapy (ART) adherence and risk reduction intervention, Project ADHerence~     Education and Risk Evaluation (ADHERE). Project ADHERE was compared to a single-session~     group-based medication adherence intervention, Medication Adherence and Care Engagement~     (MACE).~      A secondary aim was to examine the impact of Project ADHERE on HIV risk behaviors (i.e.,~     illicit drug use and unprotected sexual behavior).~      This study was designed to inform, design, and pilot test the two antiretroviral medication~     adherence interventions for HIV-infected formerly incarcerated individuals.~   "
20328|NCT03300895|"~     High-intensity interval training (HIIT) is currently considered one of the most effective~     strategies to improved cardiorespiratory fitness, which is recognized as a protective factor~     for cardiovascular diseases and metabolic diseases such as overweight and obesity. However,~     current evidence is still limited and requires clarity (frequency, time per session and~     intensity) regarding to greater increases attributed to HIIT.~      The aim of this study is to compare the effect of a low-volume high-intensity interval~     training versus a moderate-intensity continuous exercise on maximal oxygen consumption in~     overweight women 18 to 44 years old.~   "
20329|NCT03300882|"~     The overall objective of this study is to establish a personalized test to measure~     individualized cytomegalovirus (CMV) specific immunity in lung transplant recipients in an~     effort to guide antiviral prophylaxis duration in clinical practice.~      Targeted participants are those:~        -  enrolled in clinical research study CTOT-20 (Clinical Trials.gov ID: NCT02631720) who~        -  are CMV recipient positive by serology as determined using methods in accordance with~          current local organ procurement organization policies.~   "
20330|NCT03300869|"~     The primary objective of this study is to investigate the natural history of spinal muscular~     atrophy (SMA) types 2 and 3 patients in Taiwan. This study will provide further insights into~     the clinical course SMA. Several analyses will be conducted regarding overall survival,~     demographic characteristics, motor function, respiratory and nutritional support, and~     genotype and phenotype correlation.~   "
20331|NCT03300856|"~     Background:~      TMS stands for transcranial magnetic stimulation. It is a non-invasive way to stimulate the~     brain. It helps researchers study the nervous system. TMS can assess central motor conduction~     time (CMCT). That can be used to diagnose some diseases. It can also show how well treatments~     are working. Researchers want to study the records of people who have already had TMS. They~     want to see how it relates to the results of diagnostic studies.~      Objectives:~      To study the results of transcranial magnetic stimulation in certain neurological disorders.~     To create a descriptive analysis of the results.~      Eligibility:~      Records that are already in the NINDS database~      Design:~      The study will not enroll any participants.~      Researchers will search the database for certain terms. These include TMS, CMTC, and motor~     evoked potentials. This will identify records of people who had TMS for diagnosis.~      Using data from the records, researchers will calculate CMCT. They will note other data that~     relate to CMCT.~      Researchers will analyze their findings. They will write a review article.~      Personal data will be removed from all the records before the findings are analyzed.~   "
20332|NCT03300843|"~     Background:~      Exomes are the parts of DNA that make proteins. Researchers are finding a way to read the~     letters in the exome. Incorrect letters are called mutations. Tumors contain specific~     mutations. Researchers can find these mutations in tumors to make treatments. Researchers~     want to use pieces of participants tumors to find the tumor-specific mutations. They also~     will take participants white blood cells to make a vaccine that they hope will shrink the~     tumors.~      Objectives:~      To see if dendritic vaccine tumor-fighting cells are safe and can cause certain cancer tumors~     to shrink.~      Eligibility:~      Adults ages 18-70 who have metastatic melanoma or metastatic epithelial cancer~      Design:~      The first part of this study was done under protocol 03-C-0277. In that study, white blood~     cells and pieces of participants' tumors were taken to make a vaccine.~      In this study, participants will get a vaccine every 2 weeks for 8 weeks. It will be given~     both in a vein and under the skin. At each visit, participants will have a physical exam and~     have blood taken. They will talk about any side effects they have.~      After treatment ends, participants will have many follow-up visits for the first year, then~     once each year after that. Visits will last up to 2 days each. They will include lab tests,~     imaging studies, and a physical exam. Blood will be taken at each visit. At the first~     follow-up visit, participants may have leukapheresis, which they also had as part of protocol~     03-C-0277. Participants may not have to return to the Clinical Center for these visits.~   "
20333|NCT03300830|"~     Background:~      A person s genome is the collection of all their genes. A gene instructs individual cells to~     make proteins. Proteins are involved in all of our body s chemical processes. Genome~     sequencing allows researchers to find variations in genes. Some of these are normal and are~     not known to cause disease. Some variants are known to cause or affect diseases like cancer.~     Researchers want to study genetic variants in people with cancer who also have an immunologic~     disease like HIV.~      Objective:~      To study the biology of cancer in order to improve ways to prevent, detect, and treat it.~      Eligibility:~      Adults at least 18 years old with certain cancers and/or immunodeficiencies~      Design:~      Participants will be screened with medical history, physical exam, and lab tests.~      Participants will give samples of one or more tissue type.~      They may give blood or urine samples.~      Researchers may get samples of tissue when participants have surgery or when the participants~     are on other protocols in the NCI.~      Participants may have a procedure to have tissue samples removed.~      Researchers may collect data from participant medical records.~      Researchers will compare the genes in a participant s cancer tissue to their normal tissue.~     They may use the tissue cells to grow new cells in a lab.~      Participants may be contacted about the results.~      The samples will be stored for future research. No personal data will be kept with them.~   "
20334|NCT03300817|"~     This pilot phase I trial studies the side effects and how well MUC1 peptide-Poly-ICLC vaccine~     works in preventing lung cancer in current and former smokers at high risk for lung cancer.~     Vaccines made from peptides may help the body build an effective immune response to kill~     cells. MUC1 peptide-Poly-ICLC vaccine may stimulate the body's immune system and slow or stop~     the changes from normal to pre-cancer to cancer.~   "
20335|NCT03300804|"~     The purpose of this study is to determine whether a 20- herb formulation, as a well~     characterised extract, is efficacious in treating irritable bowel syndrome (IBS) and also to~     identify efficacious and safe dosage of the formulation in treating IBS.~   "
20336|NCT03300791|"~     This is a prospective nested case-control study.~      Our goals are to create predictive models to readmissions for heart failure and also to~     define profiles for patients who are readmitted during the first month after the index~     episode.~      Patients who will be admitted in five hospitals in spain by the reason of a heart failure~     will be recruited during 18 months. Those who will be readmitted in a hospital up to a month~     after the index episode will be considered cases. Controls will be selected from the initial~     cohort of hospitalized patients.~   "
20337|NCT03300778|"~     This study will investigate the effects of aerobic exercise on mental states, cognition, and~     long-term outcomes in adolescents with subthreshold depressive and/or hypomanic syndromes and~     in non-clinical school children~   "
20338|NCT03300765|"~     To determine the efficacy and safety of intensity modulated radiation therapy combined with~     apatinib for inoperable or iodine refractory thyroid cancer.~   "
20339|NCT03300752|"~     The overall goal of this study to preliminarily validate a novel intervention delivered by~     primary care providers (PCPs) to their Black adult patients with uncontrolled asthma in~     federally qualified health centers (FQHCs).~   "
20340|NCT03300739|"~     This is an observational pilot study focused on collecting data on clinical variables that~     can improve the understanding of potential predictors of disease exacerbation and~     readmissions in COPD patients. The study aim is to understand how the variability of clinical~     parameters (respiratory rate, forced expiratory volume in one second, and oxygen saturation),~     physical activity and quality of life is associated with the risk of exacerbation in COPD~     patients.~   "
20341|NCT03300726|"~     The purpose of this study is to examine cross-sectional associations between CSF markers of~     synaptic injury (Ng and SNAP-25) and functional connectivity in default and semantic memory~     networks using 3T- fMRI in individuals with MCI (i.e. the earliest clinically detectable~     stage of cognitive impairment) due to AD or mild AD dementia (CDR 0.5-1; n=15) and~     cognitively normal controls (CDR 0; n=15).~   "
20343|NCT03300700|"~     Obstructive sleep apnea (OSA) can be described as a condition characterized by repetitive~     obstruction of the upper airway resulting in oxygen desaturation and awakening from sleep,~     loud snoring, and increased daytime sleepiness . Many studies have shown that a link exists~     between OSA and cardiovascular disease, chronic heart failure ischemia, hypertension,~     obesity, and impaired glucose tolerance . A number of factors are likely to play role in~     development of clinical OSA syndrome (OSAS) ranging from upper airway anatomy to central~     respiratory control mechanisms. The pathophysiology of OSA is unclear and complex. Several~     previous studies have explored pulmonary function in the OSAS patients Interestingly, OSAS~     has been found to be highly correlated with lower airway obstruction, although it is~     originally defined as an upper airway disease~   "
20344|NCT03300687|"~     This is a phase 1 safety study performed in male or female adult participants with an~     established diagnosis of severe to profound sensorineural hearing loss that meets the~     criteria for cochlear implantation and the participant has already chosen to undergo cochlear~     implant surgery.~   "
20345|NCT03300674|"~     This is a randomized, double-blind, emergency department based, comparative effectiveness~     study of two medication for acute abdominal pain: intravenous lidocaine and intravenous~     hydromorphone. Patients will be enrolled during an emergency department visit and followed~     throughout their emergency department course and then by telephone 7 days later.~   "
20346|NCT03300661|"~     The study is an open-label intervention non pharmacological Cohort Study without control arm~     in patients with Non Alcoholic Fatty Liver Disease (NAFLD) and in healthy subjects.~      The intervention in patients with NAFLD is educational, providing personalized suggestions to~     improve diet and physical activity; the intervention in healthy subjects is educational,~     providing general suggestions to improve diet and physical activity.~   "
20347|NCT03300648|"~     This study evaluates the effectiveness of two interventions in Malawian children with~     cerebral malaria at high risk of death. One-third of the participants will receive treatment~     as usual, one-third will receive treatment as usual and be placed on a mechanical ventilator,~     and one-third will receive treatment as usual plus intravenous hypertonic saline.~   "
20348|NCT03300635|"~     Fibromyalgia (FM) is a world widely common syndrome, characterized by widespread pain, often~     accompanied by general fatigue, soreness, and abnormal sensations (like pins and needles).~     The reasons and the mechanisms (pathogenesis) of FM are still poorly understood. Efficacious~     therapies cannot be developed without understanding the pathophysiological mechanisms of the~     disease or syndrome.~      FM patients suffer from pain and sense of weakness and fatigue in the muscles, and often~     report difficulty in relaxing their muscles. So far, the studies on muscle activation in~     fibromyalgia (mostly using surface electromyography) have shown some unusual functioning, a~     kind of overuse, but the results have been somewhat contradictory.~      FM symptoms share some features with small fibre neuropathy, which is a disease or~     abnormality of small nerve fibres with a diverse aetiology. Recently, several research groups~     have shown (studying both the electrical function of superficial nerves and nerve endings of~     skin samples) that up to 50% of the FM patients with severe symptoms have small fibre~     neuropathy: their small nerves do not function properly and small nerve fibre density in~     their skin is reduced. However, as this phenomenon is common but not a rule, it might be~     rather a consequence of some underlying mechanisms of the syndrome, creating even more~     symptoms.~      The aim is to investigate whether there would exist metabolic changes in FM patients that~     would create pain and lead to functional changes and damage in small nerve fibres. The~     investigators also aim to explore the muscle function particularly in distressed situations~     and at rest. The hypothesis is that a towards-overuse-altered function would create~     unfavourable metabolic changes. Third, the aim is to investigate some psychological factors~     (such as tendency to get anxious or distressed) to find out, if there is any association~     between them and muscle function.~      The FM patients as well as healthy control subjects will be recruited at Helsinki University~     Hospital Pain Clinic and from primary care at Vantaa Health Care Centre. The voluntary test~     subjects will attend~        1. A muscle function examination of 30 minutes with electromyography using surface~          electrodes, including mentally distressing tasks and relaxing periods. At the same~          session, the subject will reply to some questionnaires regarding their symptoms and~          measuring some psychological factors. Actual pain level will be assessed.~        2. A glucose tolerance test, with other blood samples~        3. A bicycle ergometer exercise test of 20 - 30 minutes, with both physiological and~          chemical (blood samples) recordings. Actual pain level will be assessed as well.~      At this stage, 40 patients and 20 healthy control subjects will be recruited.~   "
20349|NCT03300622|"~     Lung cancer is the leading cause of death in men and the second in women with a 5 year~     survival in Europe of less than 15%. One of the methods most used for its treatment is~     pulmonary resection. The objective of this study is to analyze the clinical profile presented~     to patients after pulmonary resection.~   "
20350|NCT03300609|"~     This randomized trial studies how well panitumumab, leucovorin calcium, and fluorouracil~     after combination chemotherapy and panitumumab induction work in treating patients with RAS~     wild type colorectal cancer that has spread from where it started to nearby tissue or lymph~     nodes or other places in the body or cannot be removed by surgery. Monoclonal antibodies,~     such as panitumumab, may interfere with the ability of tumor cells to grow and spread. Drugs~     used in chemotherapy, such as leucovorin calcium, fluorouracil, and oxaliplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Giving panitumumab, leucovorin~     calcium, and fluorouracil after combination chemotherapy and panitumumab induction may work~     better in treating patients with colorectal cancer.~   "
20351|NCT03300596|"~     Individuals with alcohol or drug use problems who are hospitalized for suicide attempt are at~     high risk for reattempt. This treatment development study adapts a promising outpatient~     intervention to prevent suicide reattempt in order to administer it during hospitalization to~     individuals with alcohol and drug use problems, and to test the adapted intervention in a~     pilot randomized controlled trial.~   "
20363|NCT03300440|"~     The aim of this study is to explore the effects of probiotics in individuals with a~     clinically relevant depression on psychiatric symptoms and cognition, inflammatory~     parameters, as well as gene-expression. The study is conducted as a placebo-controlled,~     randomized, double-blind, prospective, monocentric clinical study, with a two-arm parallel~     group design. Individuals in the intervention group receive the multispecies probiotics~     Omnibiotics Stress Repair in addition to vitamin B7, while individuals in the control group~     receive Placebo in addition to vitamin B7.~   "
20364|NCT03300427|"~     The study will assess the effects of 6 weeks of stable sacubitril/valsartan therapy, as~     compared with valsartan therapy, on cardiac oxygen consumption and the efficiency of cardiac~     work in patients with NYHA II-III heart failure (HF) and reduced systolic function using~     11C-acetate positron emission tomography (PET) and echocardiography.~   "
20443|NCT03299387|"~     Women have problems with oral antibiotics, including vagina and bowel infections. Also,~     bacteria causing urinary infections are becoming more resistant to oral antibiotis. Placement~     of antibiotic directly into the bladder does not cause these problems and are at doses that~     are may be able to stop bacteria from being resistant to antibiotics.~   "
20352|NCT03300583|"~     Treating and caring for people with long term conditions accounts for a substantial~     proportion of health care resources. Self-management is advocated as a mechanism that can~     empower service users with long term conditions to choose healthier options and also~     transform the relationship between service user and caregivers from one in which the former~     is a passive recipient of care to one in which they are an active partner in decision-making.~      Interstitial lung disease (ILD) is one such long term condition. Patients with ILD often~     express concern about the lack of information on possible rehabilitation programmes and other~     services that could potentially improve self-management of the disease. In addition, there is~     a general perception about a lack of co-ordination between health care professionals~     especially in relation to referral to services for comprehensive management of the disease.~     Therefore, the needs of patients with ILD and their carers, and possible gaps in service~     provision need to be explored further.~      In this study, the investigators propose to explore the needs of ILD patients from all types~     of ILD and all stages of severity and to also involve carers and clinicians. The~     investigators will conduct three focus groups for patients and carers and six one-to-one~     interviews with clinicians to explore perceptions about service gaps and needs in two ILD~     centres in South and North London, UK.~      This study will provide valuable information to develop the building blocks of a~     self-management resource and will enable the investigators to make it specific to the~     different types of ILD.~   "
20353|NCT03300570|"~     This randomized phase I trial studies the best dose and side effects of Aspirin 80mg and how~     well it works in preventing colorectal cancer in healthy participants.~   "
20354|NCT03300557|"~     This pilot phase IIa trial studies how well exemestane works in treating patients with~     complex atypical hyperplasia of the endometrium/endometrial intraepithelial neoplasia or~     grade 1 endometrial cancer. Exemestane may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth.~   "
20355|NCT03300544|"~     This phase I trial studies the best dose and side effects of talimogene laherparepvec in~     combination with capecitabine and chemoradiation before surgery in treating patients with~     rectal cancer that has spread from where it started to nearby tissue and lymph nodes. Drugs~     used in immunotherapy, such as talimogene laherparepvec, may stimulate the body's immune~     system to fight tumor cells. Drugs used in chemotherapy, such as capecitabine, fluorouracil~     and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. Radiation~     therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving talimogene~     laherparepvec, capecitabine, and chemoradiation before surgery may make the tumor smaller and~     reduce the amount of normal tissue that needs to be removed.~   "
20356|NCT03300531|"~     This is a randomized parallel controlled double-blind phase 2 clinical study.All subjects are~     recruited from the patients of rotator cuff tear, lateral epicondylitis or chronic achilles~     tendonitis. Patients will be randomly divided into three groups. Autologous pure platlet-rich~     plasma (P-PRP) and platlet-rich plasma (PRP) are purified from the peripheral blood .Patients~     of case groups will receive P-PRP or PRP injection once a week for three times while the~     control group received the same dose compound betamethasone injection. Follow up visit will~     occur at 1 month,3 months, 6 months,12 months after the last injection. Clinical quantitative~     assessment will measure by the visual analogue scale(VAS). The secondary outcomes are the~     constant-murley score(CMS) and the rating scale of the American shoulder and elbow~     surgeons(ASES) and the disability of arm shoulder and hand(DASH). The objective evaluation~     methods is that the examination of MRI or ultrasound were accomplished before the first~     injection and at 6 and 12 months afterwards.~   "
20357|NCT03300518|"~     The purpose of study is to assess the efficacy of add-on estrogen pretreatment in GnRH~     antagonist protocol on oocyte retrieval as compared with GnRH antagonist protocol for~     patients with poor ovarian response Add-on estrogen pretreatment protocol is superior to none~     pretreatment GnRH antagonist protocol for the number of oocytes retrieval~   "
20358|NCT03300505|"~     The purpose of this study is to test the effectiveness (how well the drug works), safety, and~     tolerability of the investigational drug combination of ARRx (also known as AZD5312) plus~     pembrolizumab in patients with metastatic castration resistant prostate cancer.~   "
20359|NCT03300492|"~     The study examines the application of expanded natural killer cells (NK cells) following~     haploidentical allogeneic hematopoietic stem cell transplantation (haplo-HSCT) for AML or~     MDS. Haplo-HSCT is a preferred treatment option for patients with AML or MDS without a~     HLA-matched donor. With administration of cyclophosphamide post-transplant , the safety of~     the procedure is similar to a HSCT from a HLA-identical donor. Relapse of AML/MDS represents~     a serious problem following haplo-HSCT. NK cells are immune cells able to destroy tumor~     cells. Their potency has been established particularly in the setting of a haplo-HSCT. In the~     current study, study participants undergoing haplo-HSCT will receive expanded NK cells from~     their respective stem-cell donors following haplo-HSCT. The primary goal of the study is to~     establish the safety and feasibility of this approach. In addition, the activity of the NK~     cells will be examined.~   "
20360|NCT03300479|"~     Intracerebral hemorrhage (ICH) is responsible for 10-15% of primary strokes. ICH is a dynamic~     process with three phases: initial hemorrhage, followed by hematoma expansion and~     perihematoma edema formation. Hematoma volume is correlated with disease progression and~     outcome. Contemporary evidence proposes that elevated blood pressure is associated with~     hematoma expansion while more than 90% of patients with ICH present with acute hypertension.~     Uncontrolled blood pressure is a leading cause of ICH and it seems also to be a factor of~     poorer outcomes. Therefore, rapid reduction and control of blood pressure might ease disease~     progression and improve the outcome. Clevidipine (Cleviprex®), an ultrashort-acting~     dihydropyridine calcium channel antagonist, with its rapid onset and short duration might be~     more effective than conventional antihypertensives to achieve rapid blood pressure control in~     patients with acute ICH.~   "
20361|NCT03300466|"~     This is a study to assess the performance and safety of GP0045 when injected in the~     nasolabial folds.~      There is an 18 months follow up period.~   "
20362|NCT03300453|"~     This is an open-label, phase I/II study of intra-cerebral administration of~     adenovirus-associated viral vector containing the human NAGLU cDNA to children suffering from~     Sanfilippo type B syndrome.~   "
20365|NCT03300414|"~     The focus of the study is to identify viral factors and host immune responses that~     differentiate HBV-related HCC patients from HBV patients who have not progressed to HCC. To~     that end, the investigators will compare gene expression levels between HCC patients and~     non-HCC patients categorized into high and low risk profiles. The investigators will perform~     ANOVA to compare three groups (HCC, high risk, low risk). Multiple comparison corrections~     will be performed using Benjamini and Hochberg False Discovery Rate (FDR) with a 90%~     confidence that the discovery lists will contain no more than 5% false positives (FDR<0.05)~     (PMID: 12584122, 11682119). A p-value <0.05 is considered statistically significant using~     this multiple comparison correction approach. Post-hoc Student-Newman-Keuls or Tukey tests~     will be used following ANOVA for comparisons of HCC patients with high risk and low risk. If~     data are not normally distributed when log-transformed, then Kruskall-Wallis tests will be~     used. ANCOVA will be used to adjust for the effects of covariates, such as age, gender, and~     HBV genotype (B or C). Further, the investigators often use an additional 2-fold change~     criterion for significance because the investigators consider a fold change of this magnitude~     to be biologically significant. Hierarchical clustering analyses and principal component~     analyses will be used to visualize how well the genes separate the groups, or to discover new~     subgroups. For the analysis of SNVs, the exact binomial test will be performed and p-values~     will be adjusted by the Benjamini-Hochberg correction.~   "
20366|NCT03300401|"~     This pilot clinical trial studies how well contrast-enhanced ultrasound in diagnosing~     patients with liver cancer who are undergoing Yttrium-90 radioembolization. Contrast-enhanced~     ultrasound may provide detailed imaging of the tumor arteries after the injection of a~     contrast-agent consisting of microbubbles, and may predict how much Yttrium-90 will deposit~     in the tumor.~   "
20367|NCT03300388|"~     Dysfunction of adipose tissue in obesity, inflammation and aging: mechanisms and effects of~     physical exercise and omega-3 fatty acids.~   "
20368|NCT03300375|"~     A three-month, randomized, controlled study will be used to examine the effects of a~     home-based resistance exercise program on improving pain severity and functional ability in~     unilateral lower extremity amputees who suffer from Low Back Pain. The study will follow the~     principles of the Consolidated Standards of Reporting Trials for randomized, two group,~     parallel studies.~   "
20369|NCT03300362|"~     A Phase IIb randomised, participant-blinded, placebo-controlled, multi-centre phase IIb~     efficacy study in 2030 volunteers aged 65 and over. The study will assess the safety and~     efficacy of the co-administration of a viral vectored vaccine, MVA- NP+M1, and the annual~     recommended licensed inactivated influenza vaccine (IIV). Within the main cohort 100~     participants will be recruited to an immunology sub-cohort.~   "
20370|NCT03300349|"~     This study aims to determine the effectiveness of the different programmes of four Spanish~     hospitals about prevention of axillary lymphadenectomy sequels in breast cancer patients.~   "
20371|NCT03300336|"~     Optimizing Function and Independence Through STRIDE aims to implement the STRIDE inpatient~     hospital mobility program at 8 VAMC sites in a stepped-wedge design and evaluate patient~     outcomes before and after the program is implemented, as well as the efficacy of a usual vs~     enhanced implementation design.~   "
20372|NCT03300323|"~     Administration of intravenous fluids is a key step in the management of the post-operative~     patient. Fluid management has been identified as one area that can affect rates of~     post-operative complications and outcomes. It is important to give the right amount of fluid,~     enough to optimise cardiovascular function, but not so much that we flood the cells. To guide~     this, we use a fluid challenge, administration of a small amount of fluid to test the~     cardiovascular response. At present there is significant inter-user variability in the method~     of administration of a fluid challenge. To ensure accuracy and reliability in assessing the~     response to a fluid challenge, the optimal method of administration needs to be determined.~      The aim of this study is to investigate the optimal rate to give a fluid challenge over.~     Patients will be randomised to receive a fluid challenge over either 5 or 20 minutes. Both of~     these rates are within the currently accepted range. All patients will receive a dose of~     4ml/kg of intravenous fluid. Previous work has shown this to be the optimal dose to reliably~     stress the system.~      Measurement of the mean pressure in the cardiovascular system (mean systemic filling pressure~     or Pmsf) during the administration of a fluid challenge will be used to assess which rate of~     administration effectively challenges the cardiovascular system. Pmsf is measured using a~     pneumatic tourniquet inflated for sixty seconds, above an arterial line. The invasive~     arterial pressure is observed to then determine Pmsf. Cardiac output will also be monitored~     during and after administration of the fluid challenge. Since the microcirculation may remain~     impaired despite stabilisation of the macrocirculation, we will also observe this at~     baseline, on completion of the fluid challenge, and at 5 minute intervals for 15 minutes.~     This is observed using a handheld camera placed under the tongue.~      The hypothesis is that administration of a fluid challenge at a faster rate, over 5 minutes~     as opposed to 20 minutes, will be a more effective test of the cardiovascular response. An~     effective fluid challenge is defined as one that causes a significant rise in mean systemic~     filling pressure. As such, a higher proportion of responders will be seen in response to the~     faster rate of fluid challenge. A responder is defined by an increase in cardiac output or~     stroke volume of more than 10% from baseline in response to a fluid challenge.~   "
20373|NCT03300310|"~     The increasingly used oral anticancer treatments allow the patient to reduce treatment and~     social constraints to reduce hospitalization costs. The counterpart is a decrease in the~     monitoring of the correct intake of drugs and the detection of side effects. These two risks~     are major in the elderly, due to comorbidities, poly-medication and decreased attention. The~     project objective to evaluate the impact of a bi-weekly nursing visit to the patients' homes~     for 3 months, compared to a conventional management without a nursing visit. It is a~     prospective, randomized, controlled, multicenter study to include 224 patients over 18~     months. The impact will be assessed by counting the tablets not taken and by filling an~     observation booklet with the nurse at home.~   "
20389|NCT03300102|"~     In England, more than three hundred thousand people are diagnosed with cancer each year. The~     diagnostic and treatment pathways for multiple cancers have greatly developed over the past~     decade. However, novel treatments are expensive and currently discrimination between~     responders and non-responders is still suboptimal. There is a pressing need to develop tools~     that allow for better disease characterisation and stratification. Personalised medicine,~     whereby prevention, diagnosis, and treatment of diseases is aimed at the individual level, is~     a growing field. Predicting patient-specific treatment response is challenging as response~     depends not only on the characteristics of cancer cells but also on how these cells interact~     with their immediate surrounding environment and on how the tumour interacts with the host. A~     simplistic model is therefore insufficient to predict treatment response. Complex,~     patient-derived animal models have been used to this effect but are expensive, may take up to~     6 months to provide clinically relevant answers, and pose ethical issues. In the past in~     vitro models lacked complexity as they were based solely on the two-dimensional (2D) growth~     of cancer cells. Nowadays the use of 3D tumour models has provided an extra level of~     complexity to in vitro studies. With these models it is possible to recreate tumour~     characteristics that were lost in 2D, such as cell-cell interaction between cancer cells and~     between cancer and stromal cells, cell-matrix interaction, or hypoxia.~      The investigators have developed a 3D complex tumour model - named tumouroid. Using this~     model, preliminary work has been undertaken which allows the growth of patient-derived~     tumouroids using primary cancer cells from patients.~      This personalised platform can be challenged by therapeutics used in clinical practice and~     response to treatment can be assessed via appropriate assays.~      The study goals are twofold:~      To assess patient acceptability to the use of patient derived tumour models for future~     decision-making, and To assess the feasibility of generating patient derived renal cancer~     tumouroids and using them as platforms to test drug response.~   "
20374|NCT03300297|"~     Background: Temporomandibular disorder (TMD) is a common and costly problem that often leads~     to chronic pain or dysfunction. There is moderate evidence to support physical therapy (PT)~     interventions for individuals with TMD, yet they continue to be an underserved population. A~     known relationship between TMD and the cervical spine exists with some evidence to support~     the use of cervical interventions for TMD. Cervical spine thrust joint manipulation (TJM) is~     an effective PT intervention that has been explored in a limited fashion for this population.~      The purpose of this trial is to determine the immediate and short term (1 and 4 week) effects~     of cervical TJM delivered by a physical therapist on pain, dysfunction, and perception of~     change in persons with a primary complaint of TMD. The hypothesis is that all participants~     will improve, and those in the cervical TJM group may have a greater degree of improvement.~      Design: Participants will be randomized to one of two groups and all will receive physical~     therapy. Forty-two willing participants, age 18-65 with TMD will complete the informed~     consent process and screening for eligibility before being admitted. Participants will~     receive a combined treatment of 1) behavioral education, a home exercise program, soft tissue~     mobilization, and cervical spine TJM or 2) behavioral education, a home exercise program,~     soft tissue mobilization, and sham manipulation. Participants will receive 4 treatments over~     a period of 4 weeks.~      Significance: The results of this clinical trial will provide evidence relative to the impact~     of cervical spine TJM in the treatment of persons with TMD. Determining the effectiveness of~     cervical spine TJM included with a combined treatment approach has clinical implication for~     physical therapists and the patients they serve.~   "
20375|NCT03300284|"~     This study is being done to understand the decision-making process regarding management~     choice in low-risk papillary thyroid cancer.~   "
20376|NCT03300271|"~     The purpose of this randomized study is to assess the efficacy of a mobile application for~     the improvement of blood pressure and insulin resistance in people with metabolic~     abnormalities.~   "
20377|NCT03300258|"~     The aim of this Pilot study is to determine whether robotically targeted lower-limb pedaling~     therapy can increase the extent of stroke recovery on behavioral measures and induce brain~     plasticity as measured by functional magnetic resonance imaging (fMRI). Forty (40) adult~     stroke patients and 80 healthy controls will be enrolled in this study. Of the 40 patients,~     half will be randomly assigned to the robotically-targeted training (robotic) group and~     will receive training on the targeted training task. The other half of the patients will~     perform a duration-matched aerobic pedaling exercise (control group). All stroke patients~     will be scanned before and after their training program while performing or imagining simple~     motor tasks. Behavioral assessments of motor and cognitive capacities will be collected at~     each timepoint. Healthy control subjects enrolled for device testing (20) will receive up to~     5 training sessions in a modified robotic paradigm and 1 fMRI scan, in order to investigate~     motor learning and brain activity in a novel motor control task. Additional healthy pilot~     subjects (up to 60) will test training protocols and assessments during preparatory design~     phases of the project.~   "
20378|NCT03300245|"~     The aim of the study is to evaluate the relationship between the direction and degree of~     nasal septal deviation with nasal bone morphology , along with factors such as age and~     gender.~   "
20379|NCT03300232|"~     Up to one-half of those in treatment for alcohol use disorder (AUD) has a co-occurring~     anxiety disorder (comorbidity), a condition that marks a high degree of treatment~     resistance, severity and relapse risk in AUD treatment patients. The investigators~     conceptualize comorbidity as a feed-forward system (vicious cycle, [VC]) of interacting~     negative affect/stress, drinking motives/behavior, coping skills deficits, environmental~     circumstances, and neurobiological adaptations. Based on this model, the investigators~     developed and validated the VC cognitive-behavioral therapy (VC-CBT) to disrupt this system~     at several key linkage points. In a recently completed randomized controlled trial (RCT), the~     investigators found that adding the VC-CBT to standard AUD inpatient treatment resulted in~     better alcohol outcomes 4 months following treatment than did adding an anxiety treatment or~     standard~   "
20380|NCT03300219|"~     Most surviving hip-fracture patients experience reduced mobility and lose their functional~     ability, which increases the risk of complications and rehospitalization. Post-discharge~     transitional programs to reduce readmissions have shown some success. Telerehabilitation~     refers to the use of technologies to provide rehabilitation services to people in their~     homes. Considering the need for long-term follow-up care for people with hip fracture,~     in-home telerehabilitation could increase independence, decrease hospital stays and reduce~     the burden for caregivers.~      The purpose of the pilot study is to examine the feasibility and acceptability of the~     research methods evaluating telerehabilitation with adults who have experienced hip fracture,~     in preparation for a larger randomized controlled study. A one-group (N=6) pre-test/post-test~     design is currently being constructed. Results of the pilot study will be used to determine~     what adaptations to the design may be required to ensure successful implementation.~     Recruitment, retention and attendance rates, as well as percentages completing the outcome~     measures, will be examined to plan the time frame of the main trial.~      The intervention will include 10 videoconferencing sessions from an occupational therapist in~     the presence of the primary caregiver. Each session will be utilized to guide the~     participants to achieve their self-identified goals, focusing on problem-solving for daily~     life situations and on the ability to implement the discussed strategies for a variety of~     activities.~   "
20381|NCT03300206|"~     The Brevera Breast Biopsy System integrates tissue acquisition, real time imaging, and post~     biopsy handling all during the same procedure. This post-market clinical trial will be~     performed to obtain clinical/operational data and feedback on the Brevera Breast Biopsy~     System as compared to the current standard-of-care breast biopsy procedures~   "
20382|NCT03300193|"~     The study will investigate Essential Tremor and Parkinson's Disease patients who underwent~     Magnetic Resonance guided Focused Ultrasound Surgery (MRgFUS). We will evaluate the effect of~     lesion characteristics on tremor and on quality of life after the procedure as compared with~     the baseline prior to the procedure.~   "
20383|NCT03300180|"~     This study will measure the risks and benefits of early screening of Alzheimer's disease.~     Early diagnosis through screening may enhance the family member's transition to a family~     caregiver and reduce caregiver burden by providing an opportunity for the family member to~     learn about the syndrome, receive interventions, and to prepare for their new care giving~     role.~   "
20384|NCT03300167|"~     This interventional study is using the PlaqueTec LBS will enrol participants already~     undergoing coronary angiography as a component of their standard care for NSTE-ACS. The study~     will involve no change to medication or overall treatment strategy, but will involve an~     additional procedure: use of a novel CE-marked coronary artery catheter to obtain~     spatially-separated intravascular samples for laboratory measurement. As a safety objective~     and as a component of the required post-marketing surveillance, OCT will be performed before~     and after deployment of the LBS, and patients will be followed up for a significant period of~     time by the investigator's post-procedure.~      Individual participants will not gain directly from taking part in the study, other than~     having access to more prolonged follow up than is standard. However, new insights will be~     gained into the microenvironment surrounding a ruptured plaque in NSTE-ACS, which has the~     potential to benefit patients with CAD in the future through greater understanding of the~     effects of current therapy, development of new treatment strategies and methods of assessing~     the efficacy of those treatment strategies.~      Use of the LBS and the associated OCT examinations will require additional angiographic~     screening and therefore lead to greater exposure to radiation and higher contrast load. This~     will be closely monitored as per Trust policies in line with IRMER and local radiological~     guidelines. Patients at particular risk of developing complications from increased exposure~     to radiation and contrast (eg. those who are pregnant and those with abnormal baseline renal~     function) will not be included in order to minimise adverse effects.~   "
20385|NCT03300154|"~     Cardiovascular diseases are increasing throughout the developing world and are the cause of~     almost 16.7 million deaths each year, of which 80% occur in low and middle-income countries.~     As more than three fourth of the global burden of cardiometabolic diseases are related to~     risk factors connected with lifestyles or behaviors, such as smoking, unhealthy eating, low~     physical activity, and harmful consumption of alcohol. This burden could be dramatically~     reduced by changing individual behaviors. This study is focused on interventions that are~     aimed to improve the adherence to treatment in cardiovascular disease (hypertension), based~     on a Behavioral Economics approach. Most of public policies targeted to tackle NCDs utilize a~     rational economic model of behavior. Behavioral economics, by using insights from cognitive~     psychology and other social sciences, has drawn a lot of attention for its potential to~     increase healthy behaviors. Interventions informed by BE principles seek to rearrange the~     social or physical environment in such a way to 'nudge' people towards healthier choices and~     behaviors.~      Main objective: to assess whether the implementation of two strategies based on behavioral~     economics, that include the use of a financial incentive scheme and specific framing to~     beneficiaries (i.e. mobile health interventions), increase the referral, evaluation and~     follow-up of people with moderate and high cardiovascular risk in the public health network,~     compared to the usual strategy.~      Design: A cluster-randomized pragmatic clinical trial will be performed. The randomization~     unit will be the Community Health Centers (CHC) and the intervention groups (2 arms) or~     control will be assigned to 9 health centers in total (3 CHC per arm).~      Population: This RCT is going to be conducted in selected CHC of Salta. Nine CHC will be~     selected, which will be randomized: 3 centers to the control, 3 centers to framing~     intervention with messages and 3 centers to the intervention with incentives.~      A total of 900 patients ≥ 40 years, without health coverage and with a 10-year cardiovascular~     risk ≥ 10% will participate in this study.~      Follow up: 3 month~   "
20386|NCT03300141|"~     The goal of this research study is to increase understanding of error augmentation by~     applying it to visual feedback during motion tracking with a Leap Motion device - a recently~     developed optical hand tracking tool - and the LookingGlass - a new, portable virtual reality~     environment.~      In conjunction with the Leap, large, three dimensional work spaces can provide an immersive~     and virtual augmented environment for rehabilitation. Previously, experiments have utilized~     the Virtual Reality Robotic and Optical Operations Machine (VRROOM) to create such visually~     immersive environments. The Robotics lab as part of the Arms and Hands Lab on the 22nd floor~     of the Shirley Ryan Abilitylab has developed a portable version of this system, which is more~     compact and clinic-compatible. Combining this visual 3D system with the Leap creates a novel,~     more capable apparatus for studying error augmentation.~      This research study will have 3 different arms: 1.) a healthy group of individuals (Healthy~     Arm), 2.) a group of stroke survivors within 8 months of stroke (Acute Arm), and 3.) a group~     of stroke survivors that had their stroke more than 8 months ago (Chronic Arm).~      Each Arm will use the Leap motion tracker and the Looking Glass to participate in a reaching~     intervention. The healthy arm will only participate in 1 visit with an intervention with and~     without error augmented visual feedback. The Acute Arm and the Chronic Arm will both have 2~     groups: 1.) Error Augmented Visual Feedback group and 2.) Non-Augmented or Veridical Visual~     Feedback group.~      The Chronic Arm will have a structured intervention and evaluation protocol: Study staff will~     administer outcome assessments at 3 time points: a.) prior to intervention, b.) post~     intervention, and c.) 2 months after the conclusion of intervention. Intervention will occur~     over the span of 6-8 weeks with the goal of 3 1-hour sessions per week.~      The Acute Arm will have a less structured intervention that will occur while the participant~     is an inpatient at Shirley Ryan AbilityLab. Study staff will administer outcome assessments~     at at least 2 time points: a.) prior to intervention, b.) post intervention just prior to~     discharge from Shirley Ryan AbilityLab. Between initial and post intervention evaluations,~     midpoint evaluations will take place at a maximum of once per week if the participant's~     schedule, activity tolerance, and length of stay allows. Intervention will consist of 1-hour~     sessions occurring according to the availability of the participant at the rate of no more~     than 2 sessions in a 24 hour period.~      Investigators hope to investigate these questions:~        1. Can the movement of healthy individuals be characterized with error augmented visual~          feedback and veridical visual feedback?~        2. Will error augmented visual feedback or veridical visual feedback result in greater~          movement ability improvement?~           Investigators hypothesize that in the Chronic Arm, those what trained with~          error-augmented visual feedback will have improved movement ability compared to those~          who trained with veridical visual feedback.~        3. Is treatment with the looking glass and leap system feasible with an inpatient~          population?~      Investigators hypothesize that this treatment will be feasible for an inpatient population.~   "
20387|NCT03300128|"~     Early intervention for children with Autism Spectrum Disorder (ASD), particularly with parent~     involvement, is beneficial for both children and their families. However, few interventions~     have been rigorously tested which explicitly address parent and family outcomes. This study~     will test the effectiveness of The Incredible Years Parent Program for Autism Spectrum and~     Language Delays (IY-ASD) program for parents of children with ASD ages 2-8 in a~     community-based setting, compared to a parent support program, Circle of Parents. The~     investigators will assess parent stress, caregiver coping, child behavior, parenting~     practices of participants. In addition, the investigators will report on participants'~     satisfaction with IY-ASD, through parent interviews and satisfaction surveys.~   "
20388|NCT03300115|"~     The study is a single-arm, multi-center, open-label clinical trial. The study aims to expand~     the sample size based on the fixed dose recommended by the results of previous dose~     exploration studies in order to further evaluate the study drug's efficacy and safety.~   "
20390|NCT03300089|"~     Background: Lumbar spine surgery can be performed using different anaesthetic techniques such~     as general endotracheal anaesthesia (GA) or spinal-based regional anaesthesia (RA), that have~     different side effect profiles (e.g. opioids - nausea, vomiting, pruritus, sedation; local~     anaesthetics - motor weakness) which may affect quality of recovery in different ways.~      Aim of the study: The purpose of this study is to determine the effects of GA and RA in~     lumbar spine surgery on clinical outcome, combining validated patient-reporting instruments~     and morbidity such as serious adverse events.~      Hypothesis: The investigators hypothesize that in patients undergoing lumbar spine surgery,~     RA shows significant advantages as compared to GA with respect to the postoperative pain~     score, the degree of postoperative nausea and vomiting (PONV), the postoperative anaesthetic~     care unit (PACU) and anaesthesia time and the satisfaction of patients and surgeons.~      Design of the study: This is a single-centre two-arm randomised-controlled trail.~   "
20391|NCT03300076|"~     A multicenter, open, non-interventional, prospective, clinical observational study on~     Conformity to Therapy and Quality of Life in Asthma in patients living in Greece~   "
20394|NCT03300037|"~     The HYPNOS study is an acute feasibility study to validate a new device for automatic~     detection and treatment of sleep apnea syndrome. The system is known as the PASITHEA system~     and it will perform the following tasks:~        -  Detect apneas and hypopneas in real time, based on physiological signals acquired with a~          cardiorespiratory holter (nasal air flow, heart rate and blood oxygen saturation (SaO2))~        -  Upon detection of apnea or hypopnea events, trigger kinesthetic stimulation of~          mechanoreceptors of the skin close to the mastoid bone~      The primary objective is to verify that the PASITHEA system is able to detect apneas and~     hypopneas reliably.~      The main secondary objective of the study is to assess the effect of kinesthetic stimulation~     on reducing the number of sleep respiratory disorders.~      Another objective of the study is to verify the safety of the PASITHEA system.~   "
20395|NCT03300024|"~     The investigators propose a randomized study to compare bovine carotid artery (BCA) biologic~     grafts and expanded polytetrafluoroethylene grafts (ePTFE) for permanent hemodialysis access.~   "
20396|NCT03300011|"~     Chronic total occlusions (CTO) are encountered in almost one-fourth of patients undergoing~     coronary angiography. The presence of an untreated CTO has been related to adverse clinical~     prognosis, both in stable angina and acute myocardial infarction, and is often associated~     with persistent symptomatic angina. Depending on their symptomatic and functional status as~     well as anatomical complexity, CTO can be treated by optimal medical therapy only or therapy~     combined with coronary revascularization. This study designed to evaluate the safety and~     efficacy of coronary chronic total occlusion PCI by ultrasonic cardiogram.~   "
20397|NCT03299998|"~     Background and Objectives: Double-jaw surgery is one of the most painful oral surgery,~     requiring multimodal analgesia including controlled morphine pump and its secondary effects.~     The aim of this study was to evaluate the effectiveness of face block (mandibulary and~     maxillary block analgesia) on the first 24 hours on morphine consumption in patients admitted~     for double jaw surgery.~   "
20398|NCT03299985|"~     This study is a double blinded randomized clinical trial with two arms which aims to study~     the effects of diaphragmatic myofascial release in patients with gastroesophageal reflux~     disease (GERD).~      GERD has become in the last decades a common disease at the occidental world affecting~     between 10 to 15% of this population. That implies a high socio-health cost and the decline~     of the quality of life of those patients.~      The diaphragm muscle surrounds the lower esophageal sphincter, and helps to prevent~     gastroesophageal reflux. If one or both structures become incompetent, it may appear GERD.~     Until the moment, the treatment for GERD begins by lifestyle modification, and if it fails,~     the treatment becomes medical and, in selected cases, surgical.~      It exists some studies that have demonstrate that diaphragmatic breathing training can have a~     positive effect in GERD and the need of drug usage. But until the moment, the effects of a~     myofascial release of the diaphragm haven't been explored on these patients.~      Thirty patients with GERD referred from different hospitals of Valencia will be randomized~     into two groups:~        -  Intervention with myofascial release for the diaphragm~        -  Sham treatment group which is going to receive the same number of session treatments~          with the same manual techniques, but without the myofascial stimulus The protocol that~          will be applied consists of 4 identical sessions of myofascial release techniques aimed~          to normalize the myofascial tension of the diaphragmatic muscle. These sessions will be~          distributed in two weeks.~      The study focuses on the analysis of the following variables:~        -  Frequency and intensity of the symptoms of GERD: Reflux Disease Questionnaire (RDQ)~        -  Specific quality of life for gastrointestinal disease: Gastrointestinal Quality of life~          Index (GIQLI)~        -  Drug usage: weekly milligrams usage of proton pomp inhibitors (PPI) The results of these~          pre-intervention and post-intervention variables will be compared between the two groups~          at baseline (first session), at week 3 and at week 6.~   "
20399|NCT03299972|"~     The aim of this randomised, double-blind, placebo-controlled, parallel groups trial is to~     investigate the effects of 12 weeks resistance exercise and whey protein supplementation on~     multiple markers of sarcopenia in older men.~      Generally healthy, retired men aged 60-80 years will be recruited (n = 52 in total, n = 13~     per group). Participants will be randomised to either: a) control group [placebo only], b)~     whey protein supplement group, c) resistance exercise + placebo group or d) resistance~     exercise + whey protein supplementation group.~   "
20400|NCT03299959|"~     The current study compares the efficacy and safety of the Agili-C implant to Surgical~     Standard of Care treatment in patients suffering from joint surface lesions of the knee. The~     patient population is heterogeneous, involving different kinds of joint surface lesions:~     focal cartilage lesions, osteochondral defects and mild to moderate osteoarthritis, including~     multiple defects.~   "
20401|NCT03299946|"~     The proposed study is an open-label, single institution, single arm phase 1b study of~     neoadjuvant cabozantinib plus nivolumab in patients with locally advanced HCC.~   "
20402|NCT03299920|"~     This is a prospective, randomized trial of patients undergoing outpatient knee arthroscopy~     surgery and receiving a peripheral nerve block. Patients will be randomized to either receive~     standard discharge teaching or specialized teaching regarding pain control following a nerve~     block. Patients will be asked to complete a journal for 5 days recording their pain scores,~     opioid medication usage, and overall satisfaction with pain control at home.~   "
20403|NCT03299907|"~     The agricultural environment presents a unique profile in terms of epidemiology of pulmonary~     diseases. Certainly due to persistent exposure to organic particles, the prevalence of COPD~     is higher in farmers than in the general population, despite less smoking. It is likely that~     the risk of COPD depends on several factors, such as the type of farm, local conditions and~     the region where the farm is located. It is important to diagnose COPD at an early stage in~     order to initiate appropriate therapy, and implement secondary prevention with a view to~     limiting deterioration of respiratory function and reducing complications. In this context,~     the aims of BM3R project were: (1) to study the epidemiology of COPD in a large~     representative sample of French farmers, in order to identify the types of farming, working~     conditions and regions that are associated with the presence of COPD; and (2) to develop a~     score to identify patients at risk and optimise diagnosis of COPD in the context of a~     screening programme.~   "
20430|NCT03299556|"~     This is a proof of concept study to measure the effect of Wearable Health Technology (WHT),~     including the Apple Watch, iPhone, Pain App and Provider Dashboards on important clinical~     outcomes in patients treated for chronic pain. WHT will be tested in a group of chronic pain~     patients treated at a specialty pain clinic, the Geisinger Multidisciplinary Pain Program~     (MPP). Primary and secondary outcomes include pain, physical function, depression, pain~     medicine use, amount of sleep, activity levels, healthcare resource utilization and cost. The~     WHT will collect self-reported data on pain, pain management therapies, and medication~     utilization, and passively collected data on subject activity levels and sleep. Additional~     data will be collected on device utilization by patients and health care professionals.~   "
28718|NCT03191097|"~     The purpose of this study is to determine whether Ingavirin ® dosed 60 mg daily is effective~     and safe in the treatment of influenza and other acute respiratory viral infections in 7-12~     years old patients.~   "
20404|NCT03299894|"~     The delayed administration of an adequate antimicrobial therapy is a strong predictor of~     impaired outcome in patients with bacterial sepsis. Therefore, the current Surviving Sepsis~     Campaign guidelines (2016) recommend that administration of intravenous antimicrobials be~     initiated within one hour following the recognition of sepsis or septic shock.~      The quick Sepsis-related Organ Failure Assessment (qSOFA) score is a new bedside tool which~     has been recently proposed by the Third International Sepsis Consensus Definitions Task Force~     (Sepsis-3) to identify patients with suspected infection who are at greater risk for a poor~     outcome outside the Intensive Care Unit (ICU). It uses three criteria, assigning one point~     for low systolic blood pressure (SBP ≤100 mmHg), high respiratory rate (≥22 breaths per min)~     and altered mentation (Glasgow coma scale <15). The score ranges from 0 to 3 points. A qSOFA~     value ≥2 points is associated with a greater risk of death or prolonged ICU stay, these~     outcomes being more common in infected patients who may be septic than in those with~     uncomplicated infection. The definite goal of qSOFA is to hasten the management and thus~     improve the outcome of patients at risk of sepsis or septic shock.~      Many patients admitted to the hospital for bacterial sepsis or septic shock are initially~     managed in the Emergency Department (ED). This study aims at investigating whether the~     routine calculation of qSOFA at patient triage may hasten the initiation of antimicrobial~     therapy in patients admitted to the ED with suspected or proven bacterial infection,~     especially in those with subsequent criteria for sepsis or septic shock (Sepsis-3~     definition).~   "
20405|NCT03299881|"~     This study is a randomized, adaptive, parallel arm study. The treatment group will receive~     the Elira wearable patch system and provided instructions for use and advised to follow a~     1200 calorie diet. The control group will be asked to follow a 12 calorie diet only. Each~     group will be followed for 12 weeks. Total body weight loss will be measured as well as~     appetite changes. Safety data will be collected throughout the study period. Safety and~     effectiveness will be determined based on differences between the groups.~   "
20406|NCT03299868|"~     To establish the IV access strategy for terminally ill cancer patients, using comparisons of~     the safety, efficacy, and patient-perceived satisfaction between the initially routine PICC~     insertion group (routine PICC group) and general IV access group (optional PICC group).~   "
20407|NCT03299855|"~     This study concerns elderly patients with cancer with onco-geriatric assessment.~      This study propose to associate the collection of the results with the Mini-Cog and the CODEX~     with the passing of the MoCA and the MMS tests, as well as a neuropsychological assessment,~     in order to determine if the patients have cognitive impairments, to evaluate the sensitivity~     of these 4 screening tests in elderly patients seeking treatment for their cancer. The~     results of this study will make it possible, where appropriate, to adapt the practice in the~     context of oncogeriatric assessment.~   "
20408|NCT03299842|"~     This is a sub-study to ZX008-1503. Subjects will be fitted with an Embrace seizure detection~     watch and seizures detected by the watch will be compared to those entered into an electronic~     seizure diary.~   "
20409|NCT03299829|"~     This is a retrospective study to assess the clinical efficacy and safety of trientine in~     Wilson's disease patients~   "
20410|NCT03299816|"~     This Five, Plus Nuts and Beans for Kidneys Study is a single center, randomized controlled~     trial with 2 parallel arms testing the hypothesis that delivery of nutritional advice to~     adopt a Dietary Approaches to Stop Hypertension (DASH)-like diet and $30/week worth of~     fruits, vegetables, nuts and beans tailored to personal choices and availability in~     neighborhood stores, will reduce kidney damage in African Americans with hypertension and~     chronic kidney disease.~   "
20411|NCT03299803|"~     This project is intended to develop an evidence-based peer group counseling program that~     addresses depressive symptoms in men with physical disabilities. Expanding treatment options~     for depressive symptoms in men with physical disabilities will improve their access to care.~     The benefits of men with physical disabilities receiving effective treatment for depressive~     symptoms include better health, independent living, and longer life.~   "
20412|NCT03299790|"~     According to data of the International Diabetes Federation (IDF), diabetes in general affects~     approximately 415 million people worldwide and this number is still increasing.~     Cardiovascular diseases, one of the major complications of diabetes, are the leading cause of~     mortality and morbidity in the diabetic population. One of the cardiovascular complications~     is diabetic cardiomyopathy, in which structural and functional changes occur in the heart~     impairing cardiac function.~      Exercise training has already proven the benefits on glycemic control in diabetes. This is~     also the case for the effects on cardiac function. However, as results are conflicting, it~     remains unclear which elements of exercise training should be focused on. For instance,~     high-intensity interval training (HIIT) is gaining interest as positive effects are already~     shown on glycemic control. Therefore, the potential of HIIT to improve cardiac function in~     diabetes should be investigated. Further on, the effects of exercise training on cardiac~     function are mainly investigated during rest by the use of transthoracic echocardiography.~     Therefore, as data are lacking, it remains unclear how the diabetic heart functions during~     exercise.~      The aim of the present study is to investigate the effects of different training modalities~     (e.g. HIIT) on heart function in diabetes both during rest and during exercise itself.~     Therefore, cardiac function will be evaluated by the use transthoracic (exercise)~     echocardiography. This will be combined by the evaluation of several biochemical parameters.~      The results will provide more insight in the pathology of diabetic cardiomyopathy as well as~     the potential of exercise training for this cardiovascular complication. Eventually, this~     research will contribute to the optimization of exercise programs for patients with diabetes.~   "
20413|NCT03299777|"~     Compare the Fibroscan results of preeclamptic women to normal controls and to find out if the~     changes are reversible after labor.~      Materials and Methods~   "
20414|NCT03299764|"~     Comparison of a conventional non-invasive ventilation to a non-invasive pursed-lip breathing~     ventilation (PLBV) ventilation in advanced COPD~   "
20431|NCT03299543|"~     Subjects will provide blood and breath samples to evaluate the relationship between breath~     acetone and two blood-bound species: beta-hydroxybutyrate and glucose. Subjects will be asked~     to provide breath and blood samples at a baseline visit and second optional visit. The two~     visits will be spaced approximately 3 hours apart.~   "
20432|NCT03299530|"~     To analyze the difference between measured total corneal astigmatism and actual corneal~     astigmatism under different region modes and optimize the region setting.~   "
20415|NCT03299751|"~     Late-onset neonatal sepsis (LOS), occurring in newborn of at least 7 days of life, is~     frequently observed in Neonatal Intensive Care Units (NICUs) and potentially severe~     (mortality, neurologic and respiratory impairments).~      Despite its high prevalence, a reliable diagnostic remains difficult. Currently, nonspecific~     clinical signs that might be linked to other neonatal conditions, such as prematurity and~     birth defects are used to determine the diagnosis of LOS. Laboratory results of biological~     markers, such as C-Reactive Protein (CRP) and Procalcitonin (PCT) are often delayed in~     comparison with LOS onset. Blood culture results are too late and lack sensitivity.~      Excessive antibiotic use is observed in a large proportion of NICU hospitalized newborns.~     This results in an increased antibiotic resistance, microbiota modification, neonatal~     complications (pulmonary, ophthalmologic and neurologic) and mortality.~      The primary objective is to identify, on a cohort of 200 patients, the optimal biomarker~     combination with good diagnostic performance (i.e. with maximal Area Under the ROC Curve) to~     early exclude a LOS diagnostic in newborns of at least 7 days of life with suggestive signs.~      This identification will be carried out, as a secondary objective, with a sub-group of~     pre-term neonates whose birth weight is less than 1500 grams. The diagnostic value of the~     clinical signs that are suggestive of LOS will also be determined (sensitivity, specificity,~     negative and positive predictive values).~      Once identified, the biomarker combination is expected to reduce unjustified antibiotic use.~   "
20416|NCT03299738|"~     This is a single arm, single-center, non-randomized study to evaluate the safety and efficacy~     of C-CAR011 in relapsed or refractory B cell Non-Hodgkin Lymphoma (NHL).~   "
20417|NCT03299725|"~     Helicobacter pylori infection causes chronic gastritis, peptic ulcer disease and is involved~     in the development of gastric cancer.~      Current accepted strategies to eliminate the infection in children are a 10 days sequential~     treatment (proton pump inhibitor + amoxicillin 5 days followed by proton pump inhibitor +~     metronidazole + clarithromycin 5 days) or a triple therapy 14 days (proton pump inhibitor +~     amoxicillin + clarithromycin or metronidazole).~      However, there is a concern due to the growing resistance of Helicobacter pylori strains to~     antibiotics, especially clarithromycin, and the decreased efficacy of first line treatment~     regimens to satisfactorily eliminate the infection in children.~      Recent data show that combinations using bismuth salts must be considered in adults. Indeed,~     the efficacy of a 10 days of quadruple therapy with omeprazole plus a single three-in-one~     capsule containing bismuth subcitrate, metronidazole and tetracycline was shown to be highly~     superior to the standard triple therapy combining omeprazole, amoxicillin, and clarithromycin~     without related severe adverse events.~      The possibility of re-using bismuth salts on a more regular basis in pediatrics is being~     restudied through a monocentric, prospective, open label, single arm clinical trial to assess~     the safety and efficacy of a 10 days colloidal bismuth sub-citrate as an adjunctive therapy~     in combination with esomeprazole, amoxicillin and metronidazole in children aged 6-17 years,~     infected by Helicobacter pylori.~   "
20418|NCT03299712|"~     This study is a five-year, multi-center, non-randomized, non-controlled post-approval study~     designed to follow a total of 1000 consecutive qualified and consenting subjects treated with~     ArteFill® in the course of clinical practice at approximately twenty-five centers and all~     subjects must have a previously documented negative skin test prior to receiving treatment.~     The incidence of granuloma formation will be monitored.~   "
20419|NCT03299699|"~     Severe hemophilia is a rare and chronic disease characterized by spontaneous bleedings from~     early childhood, which may lead to various complications especially in joints. The diagnosis~     of this disease, but also its long term care have an impact on the relatives of the affected~     persons, including the siblings who bear daily the cognitive, emotional and social impacts of~     the disease.~      Studies conducted in the framework of pediatric chronic diseases showed that siblings of~     affected children presented a higher prevalence of physical and psychological troubles~     (emotional distress, behavioral disorders, etc.) than siblings who were not concerned by a~     disease. Few studies have been conducted in the framework of severe hemophilia, and to our~     knowledge, no study addresses this issue in France.~   "
20420|NCT03299686|"~     An unmet medical need exists for patients with moderate and severe asthma who continue to~     demonstrate symptoms despite being on standard of care medications, and are not eligible for~     other biologic therapies developed or in development for T2-high(allergic/eosinophilic)~     asthma. The purpose of this study is to determine if CJM112, an anti-IL-17A antibody,~     displays the clinical efficacy and safety profile to support further development in patients~     with inadequately controlled moderate to severe asthma with low IgE and low circulating~     eosinophil levels.~   "
20421|NCT03299673|"~     The present non-interventional observational study in the Greek population aims at collecting~     the characteristics of COPD patients selected to be given the inhaled combination of~     fluticasone propionate and salmeterol in doses of 100 μg mcg (250 μg) mcg (500 g) mcg through~     the Elpenhaler® device, to investigate (a) the effectiveness of the treatment for compliance~     and the quality of life of the patients; and (b) the safety of the drugs in patients whose~     disease is treated either in a hospital or in a private physician.~   "
20422|NCT03299660|"~     This trial is investigating the inclusion of avelumab post long-course chemo-radiotherapy in~     patients with resectable locally advanced rectal cancer. It is hypothesised that this may~     enhance the pathological and imaging response rates whilst potentially reducing the relapse~     rates. Participants will receive standard long course chemoradiotherapy (LCCRT) treatment~     with radiotherapy and 5-fluorouracil (5 FU)/Capecitabine for 6 weeks, this then followed by 4~     cycles of Avelumab and then surgical resection. The trial will measure disease response just~     prior to surgery and participants will be followed up for a minimum of 18 months (from study~     entry) and up to 42 months.~   "
20423|NCT03299647|"~     The investigators anticipate to identify specific polyunsaturated fatty acids that show~     significant differences between ADHD and control groups. In addition, these findings may~     offer more biological understanding in explaining the relationship between polyunsaturated~     fatty acids and visual memory among children with ADHD. The results will significantly~     contribute to the knowledge of the pathophysiological mechanisms of ADHD, especially the~     polyunsaturated fatty acids related to the behavioral/visual memory deficits of ADHD.~   "
25508|NCT03233061|"~     Many obese individuals experience difficulties in executing household activities. In this~     study, we investigate the cardiorespiratory fitness (CRF) of obese vs. non-obese women, and~     the impact of obesity on cardiorespiratory functioning during daily household activities.~   "
20433|NCT03299517|"~     Introduction: Recent studies have suggested that other medications may be superior to~     amiodarone in controlling ventricular arrhythmias. However, a prospective and randomized~     comparison with lidocaine has not yet been described.~      Objective: This study aims to evaluate the effectiveness and safety of the use of amiodarone~     versus lidocaine in patients with stable ventricular tachycardias.~      Methodology: For this, a unicentric, randomized and prospective study will be carried out, in~     which the two drugs will be administered in a comparative manner. Hospital data (test~     results, medical outcomes, arrhythmia reversal, complications) of patients will be analyzed~     for safety and effectiveness.~      Expected results: The use of lidocaine is not inferior to amiodarone in the tolerability and~     reversion of stable ventricular tachycardias.~   "
20434|NCT03299504|"~     This is a retrospective review of the COLTT program outcomes and factors that predict~     recovery of functional status after lung transplantation.~   "
20435|NCT03299491|"~     Ethiopia has one of the highest rates of maternal mortality among all countries in Africa and~     indeed worldwide, with a maternal mortality ratio of 676 per 100,000 live births in 2011~     (UNFPA, 2012). The majority of maternal deaths are preventable through early detection and~     management of complications, and access to adequate obstetric care (Say et al, 2014).~     However, in 2011 only 34% of women received antenatal care, 10% of births were delivered at a~     health facility and 7% of women received postnatal care during the first two days after~     delivery (Ethiopian DHS, 2011). Large distances and poor access to transport are two major~     obstacles that women face when trying to access services. In order to facilitate timely~     access to obstetric care, the Ethiopian Government introduced Maternity Waiting Areas (MWAs)~     at health centres to enable women to stay close to health facilities as they await delivery.~     Utilization of MWAs has generally been low due to the poor state of the homes and lack of~     adequate community support. This study aims to evaluate the effectiveness of two~     interventions to promote safe motherhood in increasing coverage of maternal health care~     services: (i) upgraded MWAs (ii) community and religious leader sensitization using~     information, education and communication (IEC) materials. The IEC materials are expected to~     increase leader awareness and support of antenatal care, facility deliveries, postnatal care~     and MWA use. Together with increased use of functional MWAs, improved support from leaders is~     expected to increase the proportion of facility-based births in interventions area. The~     interventions are also expected to positively impact antenatal care and postnatal care use in~     the study districts.~   "
20436|NCT03299478|"~     The purpose of this study is to validate TNM-Immunoscore in resected non-small cell lung~     cancer.~   "
20437|NCT03299465|"~     Cancer-related fatigue (CRF) after hematopoietic cell transplantation (HCT) is a persistent~     problem that limits activities and causes distress. Considering the high prevalence of CRF~     among HCT survivors and the limitations of currently existing treatments, there is a pressing~     need for establishing safe and effective options for reducing CRF after HCT. Based on~     evidence supporting the use of yoga for CRF in non-HCT populations, yoga is one option worthy~     of evaluation for ameliorating CRF in HCT patients. Yoga is easy to implement, may be~     appealing to HCT patients, and can be self-administered, which would encourage long-term use~     and potentially lead to a better control of persistent CRF in HCT survivors. The primary aim~     of the proposed study is to assess the feasibility of a yoga intervention for HCT survivors~     with CRF. Outcomes from this feasibility study will provide the information needed to design~     a larger, adequately powered randomized controlled trial to evaluate yoga for CRF in HCT~     survivors. This study will employ a mixed-methods, single-arm, pretest-posttest design with~     focus groups. Twenty HCT survivors who report at least moderate fatigue will be recruited~     from the HCT clinic, Michigan Medicine. Participants will be enrolled in a six-week~     Restorative yoga program. The program will consist of a weekly, 60-minute yoga group class~     led by a certified yoga instructor along with twice-weekly home practice using yoga DVD.~   "
20438|NCT03299452|"~     This is a single-center, open-label, single-arm, non-randomized study designed to evaluate~     PFS,safety, overall survival (OS), objective response rate (OPR), disease control rate (DCR)~     and biomarkers of cancer therapy based on the accelerated PDX model screening in subjects~     with advanced malignant tumor.~   "
20439|NCT03299439|"~     The investigators plan to investigate the effectiveness of acupuncture at highly sensitive~     points, compared with lowly/non-sensitive points or no acupuncture (waiting-list), in~     improving pain, joint function and quality of life, among patients with KOA. The safety of~     acupuncture will also be assessed during the study period.~   "
20440|NCT03299426|"~     This study will evaluate the efficacy of a Typhoid conjugate vaccine (Vi-TCV) in Malawi,~     Africa among children age 9 months through 12 years. Participants will be randomized in a 1:1~     ration to receive the study vaccine or the control vaccine (meningococcal group A conjugate~     vaccine - MCV-A).~   "
20441|NCT03299413|"~     Scientists hypothesize that directly or parentally injecting Mesenchymal stem cells (MSCs) to~     affected areas will have a positive impact through reducing or abolishing intestinal~     inflammation in part via inhibition of neutrophil Myeloperoxidase (MPOx) activity. Inhibiting~     MPOx should modify disease progression as well as reduce colitis associated cancer risk.~   "
20442|NCT03299400|"~     Post-operative visual loss is a rare but serious complication after surgery. It is most~     significantly correlated with prone spinal surgery with a prolonged duration. The cause and~     risk factors are not elucidated, but the majority of the cases are due posterior ischaemic~     optic neuropathy (PION). This entity is directly related to the ocular perfusion pressure~     (OPP), which is estimated as the difference between mean arterial blood pressure (MAP) and~     intraocular pressure (IOP). Autoregulation is believed to maintain a constant perfusion to~     the optic nerve despite fluctuations in the perfusion pressure.~      IOP is known to increase in the prone position thus putting susceptible patients at risk for~     inadequate ocular nerve perfusion. Most of the evidence comes from animal and healthy~     volunteer studies and cannot give an accurate insight into the subtle changes of~     intra-operative IOP. All the published studies employed the use of a tonometer, which may~     have rooms for measurement errors due to inadvertent pressure on the globe while retracting~     the eyelids, particularly when there is significant periorbital/conjunctival swelling in the~     prone position. The majority of the studies recruited healthy volunteers in a simulated~     surgical setting so other fluctuating parameters, which can affect intraoperative IOP, cannot~     be measured. In the few reports where patients undergoing surgery in the prone position were~     studies, IOP measurements were taken at non-continuous monitoring at time intervals, thus the~     effects of changes in blood volume, MAP, central venous pressure (CVP) and PaCO 2 could not~     be studied. Lastly, all the literature consists of case series only with no control group so~     the effect of position cannot be evaluated independently of the other factors.~      The investigators therefore propose to conduct a prospective study with continuous~     intraoperative IOP monitoring to give us further insight into the physiological changes of~     IOP in patients undergoing spine surgery, and identify the risk factors related to~     fluctuations of IOP during prone spinal surgery.~   "
20444|NCT03299374|"~     The present research aims at evidencing the effect of one of the training methodologies~     increasingly demanded by the older adult, and used to promote, maintain and enhance physical~     and biopsychosocial aspects. Consequently, we intend to base the evidence supporting Pilates~     as an effective method in the following specific aspects: balance, prevention and reduction~     of falls, and improvement of the quality of life in the older adult~   "
20445|NCT03299361|"~     Carpal tunnel syndrome (CTS) is the most common nerve compression disorder in the upper~     extremity. Therapy for carpal tunnel syndrome includes physical and occupational therapy, the~     use of splints and other local measures, and corticosteroid injection into the carpal tunnel.~     When these measures fail, open surgical release is considered the next step. Although the~     main disadvantage of corticosteroid injection is that symptoms are often short-lived relief~     and partial relief, it may not provide a permanent solution, corticosteroid injections are~     chosen because of lower level of invasiveness, faster recovery, and ease of the technique.~      Diffusion tensor magnetic resonance imaging (DTI) reveals tissue microstructure based on~     random movements of water molecules. The measured diffusion-weighted images are further~     analyzed for parameter images that describe different characteristics of diffusion: apparent~     diffusion coefficient (ADC) is an absolute measure of the strength of diffusion, and~     fractional anisotropy (FA) describes the asymmetry of the diffusion direction due to tissue~     structures. Because the axonal cell membrane and the myelin sheath in nerve fibers prevent~     diffusion in the direction which is perpendicular to their fascicles, resulting in the~     isotropy of the diffusion of water molecules being lost. DTI is the only method which can~     give an indirect view of the microstructure of nervous tissue in addition to the pathway of~     the fibers.~      DTI has been applied to study peripheral nerves, to demonstrate the feasibility of the method~     and to study nerve entrapment in carpal tunnel syndrome (CTS). The previous studies have~     demonstrated a decrease in FA in patients with CTS compared to healthy volunteers. The DTI~     parameters of the median nerve have revealed significant increase of FA and decrease in ADC~     with complete symptom relief 6 months after carpal tunnel release. However, Hiltunen et al.~     have demonstrated a significant decrease in ADC but no alter in FA in patients received open~     carpal tunnel release 1 year later and felt complete symptoms relief. By means of open carpal~     tunnel release, follow-up recordings were made at least 6 months after the operation to~     ensure time for post-operative tissue recovery. As a result, the investigators still do not~     understand the relevance between the parameters of DTI to symptoms relief in CTS patients~     receiving conservative treatment.~      Different from carpal tunnel release, steroid injections are popular technique for CTS~     treatment and are believed to reduce perineural inﬂammation or soft tissue swelling, and may~     stabilize the neural membrane, thus limiting the ephaptic transmission in ischemic nerve~     ﬁbers which causes symptoms. Corticosteroid injections can provide a rapid symptom relief at~     2 weeks follow up. However, there is no report addressing the relation of functional change~     of median nerve at several anatomic locations to the symptom relief of CTS. Here the~     investigators monitored, by means of DTI, median nerve integrity in CTS patients before and~     after corticosteroid injection. This information may help to explain the hypothesis regarding~     the effect of corticosteroid to the median nerve, to identify which anatomic location of~     median nerve relevant to the symptom relief of CTS after corticosteroid injection, and be~     useful for the clinical follow-up of patients with nerve entrapments following conservative~     treatment.~   "
20446|NCT03299348|"~     This study examines the efficacy of a psycho-educational intervention program, AgingPLUS,~     with regard to increasing middle-aged and older adults' engagement in physical activity.~   "
20447|NCT03299335|"~     This study aims at assessing the gene expression in the muscles of patients suffering from~     sporadic Inclusion Body Myositis (sIBM) at various stages of the disease, by comparison with~     muscles of control subject. The investigators use the RNA-seq technique to analyze the gene~     expression levels and potential alternate transcripts, including long non-coding RNAs~     (lncRNAs), in muscle tissue samples. The gene expression profiles will point to the genes of~     interest that can then become the object of future studies, in which epigenetic changes of~     these genes will be explored further. The value of those possible biomarkers will be~     assessed. The investigators will also evaluate the correlation between the gene expression~     profile, the degree of functional impairment, the histological picture and the presence or~     absence of autoantibodies.~   "
20448|NCT03299322|"~     Investigators aimed to assess Jia Wei Yang He Formula as a plus therapy in the treatment of~     persistent asthma and to explore Airway Microbiome variation of Asthma by Traditional Chinese~     Medicine treatment~   "
20449|NCT03299309|"~     The primary goal of this prospective clinical trial is to evaluate the safety of PEP-CMV in~     patients with recurrent medulloblastoma and malignant glioma. Patients with~     histologically-proven medulloblastoma or malignant glioma who had received definitive~     chemo-radiotherapy and subsequently had tumor recurrence/progression may be enrolled any time~     after recurrence/progression regardless of prior adjuvant therapy. PEP-CMV is a vaccine~     mixture of 2 peptides comprised in two components (referred to as Component A and Component~     B). Component A is a synthetic long peptide (SLP) of 26 amino acid residues from human pp65.~     Component B consists of a neutralizing antibody epitope from human CMV glycoprotein B (gB)~     conjugated to KLH.~   "
20450|NCT03299296|"~     The main objective is to reduce the incidence of venous thromboembolism (VTE) in orthopedic~     postoperative patients based on the potential benefit of using rivaroxaban as a monotherapy.~      It is around efficacy and safety evaluation of using rivaroxaban as a monotherapy~     prophylactic agent in patients undergoing orthopedic surgeries taking into the account the~     reliable selection of patients most benefit.~      Answering questions about additional cost benefit from the perceptive of the cost-effective~     analysis on extrapolating the results emerged to our university teaching hospital setting are~     going to be evaluating as well.~   "
20451|NCT03299283|"~     The purpose of this study is two-fold. In the first phase, the goal is to characterize the~     stability of respiratory (nasal swab, nasopharyngeal swab, and throat swab; NS, NPS, TS) and~     stool (raw stool and rectal swab) specimens collected using various standard, medically~     established procedures with and without transport media and tested at various time points and~     under different temperature conditions, and also to look at variation between repeat sampling~     events. The intention is for these data to support decisions made by BioFire regarding the~     appropriate specimen type and handling guidelines for future tests. In the second phase of~     the study, collection and transport conditions identified in Phase 1 will be used to collect~     specimens for pilot performance evaluations of a new molecular diagnostic test.~   "
20452|NCT03299270|"~     Multicenter, international, prospective, observational study, designed to evaluate the~     postoperative results in terms of quality of life and functional recovery of elderly patients~     after major cancer surgery.~      The global expected duration of the study is 3 years, during which cancer patients over 70~     years old undergoing major surgery will be evaluated before and after the surgical~     intervention, at 30 days, 3- and 6-months follow-up. The study is non-for-profit. Given the~     observational nature of the study, the original treatment plan, as designed by each~     individual recruiting centre, will not be altered or affected by the study inclusion.~     Inclusion in the study does not imply any deviation from the current standard of practice,~     and no change is expected to the perioperative treatment at any point. Patients will be only~     asked to complete simple screening/assessment tests.~   "
20453|NCT03299257|"~     It is a randomized, double-blind, single-center, 30-day study. Patients aged 35-60 years,~     with apnea and hypopnea index and respiratory disturbance index normalized with CPAP, and~     Epworth Sleepiness Scale> 11. Patients undergo baseline and CPAP titration polysomnography,~     liquor and blood collection, Multiple Sleep Latency Test, anxiety and depression and~     cognitive assessments.~   "
20454|NCT03299244|"~     To demonstrate that treatment with etelcalcetide (AMG 416) is not inferior to treatment with~     cinacalcet for lowering serum intact parathyroid hormone (PTH) levels by > 30% from baseline~     among subjects with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT) who~     require management with hemodialysis.~   "
20455|NCT03299231|"~     Sputum production increases in acute exacerbation of COPD, both in amount and consistency. It~     increases airways obstruction and hence delays improvement and prolongs hospital stay.~     oscillating positive expiratory pressure (OPEP) devices were extensively studied in cystic~     fibrosis and bronchiectasis. Only seldom studied in chronic bronchitis. This study aims to~     measure the effects of mucous clearing device in hospitalized patients with acute~     exacerbation of COPD.~   "
20467|NCT03299075|"~     This project aims to explore how social media use, in particular food photography, influences~     eating behaviours. It will be approached through three methods - a correlational experience~     sampling method, an experimental experience sampling method, and an experimental laboratory~     method. This registration describes the correlational experience sampling method.~   "
20518|NCT03298412|"~     The study will estimate the minimal residual disease (MRD)-negative response rate after~     treatment with blinatumomab in subjects with high-risk DLBCL who are MRD-positive following~     aHSCT. The clinical hypothesis is that the MRD-negative response rate will be > 10%.~     Achieving an MRD-negative response rate of 30% would be of scientific and clinical interest.~   "
31184|NCT03158883|"~     This is a pilot, single center, open-label study to examine the ORR, safety, and toxicity of~     avelumab in combination with SAR in non-responding and progressing NSCLC patients previously~     treated with a PD-1 Inhibitor.~   "
20456|NCT03299218|"~     Malnutrition is a public health problem, with long-lasting physiological consequences and~     increased risk of morbidity and mortality. It can be recognized as one of the key obstacles~     in national development, due to its influence on individual productivity, school performance~     and physical work capacity. Malnutrition is a hidden crisis in Pakistan, with rates~     increasing during the last decade. High prevalence of food insecurity, illiteracy, lack of~     nutritional knowledge, poor hygiene status, and under recognized role of nutrition are some~     of the possible causes. The situation of malnutrition in Pakistan necessitates an urgent need~     for addressing its causes through various nutrition interventions, in order to ensure a~     bright future for the coming generations.~      Although, malnutrition is a major problem across Pakistan, its burden and implications in the~     remote districts of Punjab are quite evident. The levels of undernutrition in district Rahim~     Yar Khan are high, with 47% of children being underweight. These numbers also highlight the~     presence of long-term undernutrition in the district, as evidenced by 45% of the children~     being stunted in 2014.~      Given the alarming situation of child malnutrition in district Rahim Yar Khan, the World Food~     Program (WFP) Pakistan is proposing an intervention program comprised of cash-based~     transfers, specialized nutritious foods and behaviours change communication to prevent~     stunting in district Rahim Yar Khan, province Punjab. The interventions will be delivered~     through the existing health system and Benazir Income Support Programme (BISP). It is~     anticipated that the intervention will reduce the widespread macro and micro nutrient~     malnutrition and food insecurity in the targeted areas. Furthermore, to ensure the presence~     of adequate evidence to persuade policymakers for further scaling up, it is essential that an~     impact evaluation be conducted. Therefore, the Department of Paediatrics and Child Health,~     Aga Khan University (AKU) using robust methodologies on a representative sample size in the~     district of Rahim Yar Khan to assess the effectiveness of the WFP interventions on process~     and outcome indicators.~   "
20457|NCT03299205|"~     Cross-sectional and prospective studies are proposed to test the prediction that a higher~     proportion of HIV+ individuals with hazardous alcohol drinking with subclinical fasting~     dysglycemia will present with impaired oral glucose tolerance and dysfunctional metabolic~     skeletal muscle phenotype. Prospective studies will test the efficacy of an exercise~     intervention in improving glycemic control. Results will inform larger scale interventions to~     ameliorate metabolic comorbidities, improve health, quality of life, and possibly decrease~     hazardous alcohol drinking.~   "
20458|NCT03299192|"~     There is a major gap in knowledge about safe and effective treatment options for older adults~     with chronic low back pain. This project will determine the feasibility of conducting a~     full-scale trial evaluating Tai Chi, a promising mind-body intervention that seems~     particularly well-suited for older adults with chronic low back pain.~   "
20459|NCT03299179|"~     Measuring brain perfusion is biased by a inter- and intrasubject variability, caused by~     physiological and lifestyle factors. In this study, the investigators want to investigate the~     variations in cerebral perfusion and other brain parameters (grey matter, resting-state brain~     activity, brain connectivity and white matter diffusion) caused by the female sex hormones~     and hormonal contraception.~   "
20460|NCT03299166|"~     The purpose of this study is to compare the efficacy of BHV-4157 versus placebo in subjects~     with Obsessive Compulsive Disorder (OCD).~   "
20461|NCT03299153|"~     The aim of this study was to investigate the effect of barberry juice (BJ) as a natural~     antioxidant, on cardiovascular risk factors in patients with type 2 diabetes (T2DM). In a~     randomized clinical trial study, 46 T2DM patients, 30-70 years old recruited from Diabetes~     Association of Iran-Babul . Patients were randomly allocated to either the BJ group (n=23)~     who consumed 200 ml of BJ daily for eight weeks, or the control group (n=23) with no~     intervention. At the baseline and the end of 8-week intervention, blood pressure and~     biochemical markers were conducted.~   "
20462|NCT03299140|"~     Bipolar disorder is an early onset chronic disorder. Children of bipolar parents are at high~     risk of developping the same disorder and/or a psychopathology. Early intervention focused on~     emotion and problem solving strategies could improve their prognosis.~      The main objective of this trial is to evaluate the FFT (Family Focused Therapy) efficacity.~     Children emotional dysregulation profile will be compared before and after this CBT~     intervention.~   "
20463|NCT03299127|"~     Depression is among the world's leading causes of disability. To fill the existing treatment~     gap, psychological online interventions (POIs) and Internet-based treatment, including~     bibliotherapy with PDF manuals (POIs), are increasingly recommended as they are easily~     accessible and deemed an initial alternative approach. The present trial aims to evaluate~     imagery rescripting. With the help of various techniques, the approach aims to edit negative~     memories and rewrite a happy end. To the best of our knowledge, imagery rescripting has~     never been tested as a self-help intervention. A large sample of patients with primary or~     secondary depression (N = 120) will be recruited and randomly allocated to either the~     intervention group or a wait-list control group. The intervention group consists of two~     subgroups that will receive either a full or brief version of a manual teaching them imagery~     rescripting. Participants will be assessed at baseline and six weeks later. A follow-up~     assessment will be completed six months later. The primary outcome measure is the Beck~     Depression Inventory II.~   "
20464|NCT03299114|"~     Both neuropathic and nociceptive mechanisms may contribute to the OA pain experience. Aims:~     The aim of this study was to determine the efficacy of warm whirlpool on pain, disability,~     quality of life (QoL) and sleep for patients with neuropathic pain.~   "
20465|NCT03299101|"~     Frail Veterans are at increased risk for poor surgical outcomes, and as the Veteran~     population grows older and more frail, there is a critical need to identify effective~     strategies for reducing surgical risks for these patients. Prior research shows that~     inter-disciplinary rehabilitation strategies deployed after surgery enhance recovery and~     improve outcomes by building strength and improving nutrition. The investigators believe that~     similar improvements may be obtained by using similar interventions before surgery to~     prehabilitate patients' capacity to tolerate the stress of surgery. The proposed research~     will examine the feasibility of a new, home-based prehabilitation intervention aimed at~     improving surgical outcomes after cardiothoracic surgery through preoperative exercise~     training and nutritional supplementation. Findings from the study will inform the design of a~     larger randomized controlled trial of the prehabilitation intervention. If proven effective,~     prehabilitation could benefit as many as 42,000 frail Veterans who are scheduled for major~     elective surgery each year.~   "
20466|NCT03299088|"~     This phase Ib trial studies the side effects of pembrolizumab and trametinib in treating~     patients with non-small cell lung cancer and KRAS gene mutations that has spread to other~     places in the body. Monoclonal antibodies, such as pembrolizumab, may interfere with the~     ability of tumor cells to grow and spread. Trametinib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Giving pembrolizumab and trametinib may~     work better in treating patients with non-small cell lung cancer.~   "
20468|NCT03299062|"~     Degenerative dementias including Alzheimer's Disease (AD), Parkinson's Disease with Dementia~     (PDD), Dementia with Lewy Bodies (DLB), Frontotemporal Dementias (FTLD), Corticobasal~     Degeneration (CBD) and Progressive Supranuclear Palsy (PSP) constitute a significant, and~     growing burden with an estimated cost to the US healthcare system for 2016 of $236 Billion~     (1). Definitive diagnosis of these dementias is based on pathological criterion upon autopsy,~     which presents a significant challenge to establish diagnosis in living patients. Although~     clinical diagnostic criteria have been developed for several of these disorders, including~     for Alzheimer's Disease (AD) by the National Institute of Neurological and Communicative~     Disorders and Stroke and Alzheimers Disease and Related Disorders Association (NINCDS-ADRDA)~     , Parkinson's Disease (PD) by the United Kingdom Parkinson Disease Brain Bank Diagnostic~     Criteria (UKPDBB) diagnostic criteria for Parkinson Disease(4) and others, the currently~     available tests, including the use of imaging markers and Cerebrospinal Fluid (CSF)~     biological markers do not provide a definite diagnosis since this requires the observation of~     characteristic neuropathological changes in specific regions of the brain.~   "
20469|NCT03299049|"~     This Antiretroviral Therapy as Long Acting Suppression every 2 Months (ATLAS-2M) study is~     designed to demonstrate the non-inferior antiviral activity and safety of CAB LA + RPV LA~     administered every 8 weeks (Q8W) compared to CAB LA + RPV LA administered every 4 weeks (Q4W)~     over a 48-week treatment period in approximately 1020 adult HIV-1 infected subjects. Subjects~     will be divided in 2 groups; Group 1 will include subjects receiving current anti-retroviral~     (ART) standard of care (SOC) therapy whereas group 2 will include subjects currently~     receiving CAB LA + RPV LA Q4W in ATLAS study. Subjects in both groups will be randomized to~     receive CAB LA + RPV LA Q4W or Q8W. The study will be carried out in 3 phases including~     screening phase, maintenance phase and extension phase. Subjects choosing not to enter the~     Extension phase can complete their study participation at the Week 100 visit and enter into~     the 52-week Long-Term Follow-Up (LTFU) Phase as required.~   "
20470|NCT03299036|"~     The purpose of this study is to evaluate the safety and efficacy of Radiopaque Microsphere~     (T-ACE Beads with doxorubicin) interventional therapy for patients with liver cancer~   "
20471|NCT03299023|"~     The study design of this research project involves orthodontic patients registered at the~     Harvard School of Dental Medicine who are deemed eligible to undergo orthodontic treatment~     and who have been provided with sufficient information to make informed consent to join the~     sleep study. These patients will be provided with the Medibyte sleep monitor and instructed~     on the proper manner in which it should be set up and worn for the one night study period.~     This process will be carried out twice throughout the course of the study, once before any~     orthodontic appliance has been cemented and once after the required amount of tooth movement~     has been attained with the orthodontic appliance still in place.~      The de-identified data from the Medibyte monitor will be downloaded using the Braebon~     software and analyzed.~   "
20472|NCT03299010|"~     Diabetes Mellitus (DM) is a well-recognized public health issue, affecting 415 million people~     and costing HK$5.2 trillion in global health expenditures worldwide. It is estimated 568,000~     people are living with DM in Hong Kong, and the projected number will increase to 781,000 in~     2040. In Hong Kong, the health care costs for diabetic patients are estimated to be HK$2~     billion accounting for 4.5% of the gross domestic product (GDP) per capita, and a major~     health service burden accounting for 200,000 (17% of total) hospital admissions with 1.2~     million hospitalization days per year.~      DM can lead to many complications resulting in morbidity and mortality. According to the~     International Diabetes Federation (IDF), in 2015, diabetes led to 5.0 million (14.5% of all~     deaths) deaths worldwide which translated to one death every six seconds and approximately~     70% of DM related deaths were attributed to cardiovascular diseases (CVD). The development of~     diabetes-related complications significantly increases medical costs. A previous local study~     also found that the direct medical cost for diabetic patients with CVD were 1.1 times more~     than patients without CVD in Hong Kong.~      Objectives:~      To develop 10-year risk prediction models for total CVD and all-cause mortality among Chinese~     patients with DM in primary care. Risk prediction models for individual DM complications~     including coronary heart disease, heart failure, stroke and end stage renal disease (ESRD)~     will also be developed.~      Hypotheses:~        1. Patient socio-demographic, clinical parameters, disease characteristics and treatment~          modalities are predictive of 10-year risk of total CVD, all-cause mortality and~          individual DM complication.~        2. Risk prediction models developed from this study should have over 70% of discriminating~          power.~      Design and Subjects:~      10-year retrospective cohort study. All Chinese patients who were clinically diagnosed to~     have DM and were receiving care in the Hospital Authority primary care clinics on or before 1~     July 2006 will be followed up until 31 December 2016.~      Main outcomes measures:~      For total CVD, all-cause mortality and each major DM complication~        1. 10-year incidence;~        2. Predictive factors~      Data analysis:~      The analyses will be carried out separately for men and women. Two thirds of subjects will be~     randomly selected as the training sample for model development. Cox regressions will be used~     to develop 10-year risk prediction models of total CVD, all-cause mortality and each major DM~     complication. The validity of models will be tested on the remaining one third of subjects by~     receiver operating characteristic curve.~      Expected results:~      Risk prediction models for diabetic complications specific to Chinese patients in primary~     care will enable accurate risk stratification, prioritization of resources and more~     cost-effective interventions for DM patients in primary care.~   "
20473|NCT03298997|"~     The purpose of this study is to compare two techniques for treating hemorrhoids, the ligation~     and hemorrhoidopexy technique and the conventional ligation of hemorrhoidal arteries using~     ultrasound, in patients with non-complicated hemorrhoids.~   "
20474|NCT03298984|"~     The purpose of this Phase I study is to determine the safety and tolerability including the~     maximum dose (MTD) and dose-limiting toxicities (DLTs) of alvocidib when administered over a~     range of doses on Days 1-3 followed by cytarabine/daunorubicin (7+3) on Days 5-11 in adults~     with newly diagnosed and previously untreated AML~   "
20475|NCT03298971|"~     The aim of the study is to examine the impact of cancer and treatment-related effects on the~     physical and psychosocial well-being and quality of life among Hong Kong Chinese survivors of~     childhood osteosarcoma.~   "
20476|NCT03298958|"~     The study is a multi-site Phase 3 double-blinded randomized placebo-controlled trial.~     Subjects are randomly assigned to receive either a placebo or oral Sirolimus: 0.5 mg daily.~     All subjects will be treated for 2 years or until disease recurrence. Patients will undergo~     endoscopic evaluation of the bladder every 3 months for the first 2 years following~     enrollment and then every 6 months for an additional 2 years on study. Selection of BCG~     immune therapy is at the discretion of the treating urologist but in general is reserved for~     high-risk patients. Patients concurrently receiving BCG immune therapy will receive standard~     BCG therapy including induction (weekly for 6 weeks) and maintenance (weekly for 3 weeks at 3~     months, 6 months, and then every 6 months following tumor resection).~   "
20505|NCT03298581|"~     This is an open-label, safety study designed to assess the multiple-dose pharmacokinetics and~     potential for adrenal suppression following topical treatment with halobetasol propionate~     0.05% spray applied twice-daily in adult patients with moderate to severe plaque psoriasis.~     At least 40 eligible patients with plaque psoriasis that satisfy all eligibility criteria~     will be enrolled into the study~   "
20477|NCT03298945|"~     From the patients' perspective, the most formidable part of the colonoscopy experience is the~     process of bowel cleansing. A poorly tolerated bowel preparation regimen often leads to~     incompletion of scheduled colonoscopies which in turn undermines the effectiveness of~     colonoscopy, increases cost, and decreases patient satisfaction. The current standard bowel~     preparation in the VA is of larger volume and less palatable than another commonly used bowel~     preparation regimen. The investigators propose to compare these two commonly used bowel~     preparations with respect to the overall completion rate of scheduled colonoscopies in a~     real-world VA practice setting. The results of the study can be immediately applied to~     maximize the effectiveness of colonoscopy and increase patient satisfaction in the VA.~   "
20478|NCT03298932|"~     Evaluation of the right ventricle (RV) deformation (strain) with 2D speckle tracking technics~     obtained by echocardiographies (TEE) in peroperative period of cardiac surgery .~      TEE is performed for each patient of cardiac surgery during the operation time .~      This new evaluation parameter of RV could be a good tool to assess the early RV dysfunction~     after cardiac surgery.~   "
20479|NCT03298919|"~     This is a 3-arm trial to compare exercise videogames versus traditional standard exercise~     using stationary bikes and treadmills versus a control condition. Results will examine~     minutes of physical activity at 12 weeks and 6 month follow up between conditions. We will~     also examine changes in indicators of cardiovascular health (e.g., body mass index, lipids)~     and changes in psychological factors that may be predictive of continued exercise engagement.~   "
20480|NCT03298906|"~     The purpose of this study is to evaluate the effects of ticlopidine on the pharmacokinetics~     (PK) of intranasally administered esketamine.~   "
20481|NCT03298893|"~     To date, the majority of clinical trials on checkpoint inhibitors have tested these agents as~     monotherapy, and the next logical step is to evaluate rational therapeutic associations. The~     aim of the NiCOL study is to assess the safety of nivolumab in association with~     chemoradiation therapy and to gain initial insight into its efficacy in association with the~     current standard of care, including chemoradiation.~   "
20482|NCT03298880|"~     A prototype for a Valsalva Assist Device (VAD), which provides resistance to exhalation, has~     been developed and is ready for testing in healthy volunteers. There is a need to ensure the~     device can deliver the required strain and evaluate the physiological response (lowered heart~     rate) when used to deliver a Valsalva manoeuvre (VM) with and without postural modification.~   "
20483|NCT03298867|"~     The overall objective is to investigate the efficacy, tolerability, and safety of~     teprotumumab (a fully human monoclonal antibody [mAb] inhibitor of the insulin-like growth~     factor-1 receptor [IGF-1R]) administered once every 3 weeks (q3W) for 21 weeks with a final~     assessment at Week 24, in comparison to placebo, in the treatment of participants with~     moderate-to-severe active Thyroid Eye Disease (TED).~   "
20484|NCT03298854|"~     To evaluate the diagnostic performance (sensitivity, specificity, Negative and positive~     predictive value) of skeletal co-registered SPECT/CT imaging in the detection of the etiology~     of low back pain in adolescent and adult patients~   "
20485|NCT03298841|"~     Study design will be a mix of retrospective (older Zeiss microscope previously in use at our~     surgery center) and prospective data collection with the Lumera and Callisto software.~      The Lumera and Callisto software system will be used for all cataract surgeries including~     toric analyses and lens placement.~   "
20486|NCT03298828|"~     The purpose of this study is to evaluate the safety, efficacy and blood kinetics of~     autologous T cells genetically modified to express CD19 Chimeric Antigen Receptor and PD-1~     knockout engineered T cells in patients with relapsed or refractory B-Cell Non-Hodgkin~     Lymphoma and Leukaemia.~   "
20487|NCT03298815|"~     This is a randomized, double-blinded, placebo-controlled study of AFED used for the treatment~     of chronic ocular GVHD.~   "
20488|NCT03298802|"~     Postpartum prophylactic HCTZ administration for prevention and relapse of preeclampsia or~     gestational hypertension.~   "
20489|NCT03298789|"~     In this study the investigators want to address acute effects of warm-up and static~     stretching on short-term muscular performance of football players. Static stretching~     exercises are often used in the first part of a training session or before a football match~     in order to increase sports performance and to decrease risk of injuries. Since there is a~     lot of scientific evidence that demonstrates static stretching can improve short-term muscle~     performance, the aim of researchers is to discover the size and the duration of negative~     effects and, additionally, whether these effects can be eliminated with activation exercises.~     Nineteen 14 years old football players will be included in a cross-over study design.~      In the control condition the participants will perform 5 minutes of aerobic warm-up (stepping~     on the stair) and then 7 series of 20-seconds static stretching of quadriceps femoris,~     hamstrings, hip adductors and triceps surae.~      Maximal power and jump height of the countermovement jump will be tested in between every~     series. Thus, parameters of countermovement jump will be monitored at the beginning, after~     warm-up, after each series of static stretching, 7.5 minutes after 7th static stretching~     series and 15 minutes after 7th static stretching series.~      Parameters of dynamometry (relative maximal torque [Nm/kgBM] and rate of torque developement~     [Nm/s/kgBM] will be monitored at the beginning, after warm up, 7.5 minutes after last series~     of static stretching and 15 minutes after last series of static stretching.~      Maximal range of motion will be monitored at the beginning, after warm up, during every~     series of static stretching, after last series of static stretching, 7.5 minutes after last~     series of static stretching and 15 minutes after last series of static stretching.~      In the second condition (experimental) all the tasks are the same, the only difference is~     that the subjects must perform post-activation potentiation exercises after last series of~     static stretching.~      We hypothesize that muscular performance will be impaired to a statistically significant~     level after 7th series of static stretching. Second hypothesis is that negative effects will~     not last longer than 15 minutes and the last hypothesis is that static stretching induced~     negative effects can be nullified with activation exercises.~   "
20490|NCT03298776|"~     The use of endoscopy for the diagnosis of gastrointestinal diseases has continued to increase~     in recent years.~      Endoscopy provides an advantage over other noninvasive or minimally invasive procedures in~     that it allows both direct visualisation of the mucosa but direct and accurate sampling of~     abnormalities for histological examination. However standard endoscopy does have some~     limitations particularly with small lesions and pan mucosal changes. Some lesions may be~     entirely benign and require no further intervention but as a result of difficulty with~     accurate endoscopic characterization of lesions in many cases unnecessary biopsies or~     polypectomies are undertaken. Therefore any technology that can augment the use of standard~     endoscopy to minimise unnecessary intervention should be encouraged. IScan is a digital~     enhancement technique available with Pentax endoscopes. There have been other novel~     endoscopic advances for example, Narrow band imaging but these have not been adopted widely~     for a number of reasons including technical difficulties or patient tolerability. The aim of~     this study is to assess whether Pentax IScan technology is a reliable method of improving our~     recognition of macroscopic mucosal lesions compared to standard white light endoscopy~   "
23666|NCT03257176|"~     This is a shortened interrupted time series pilot evaluation over a twelve month period to~     evaluate whether the combined Stepping Stones and Creating Futures intervention can reduce~     men's perpetration of IPV and women's experience of IPV, strengthen livelihoods and reduce~     gender inequality.~   "
20491|NCT03298763|"~     The aim of the study is to evaluate the safety and anti-tumour activity of MSCTRAIL in~     addition to chemotherapy in metastatic Non-small cell lung cancer (NSCLC) patients in a Phase~     I/II clinical trial.~      In the phase I study, patients will receive cisplatin and pemetrexed on day one followed by~     MSCTRAIL cells on day 2. This constitutes one cycle of treatment. Each patient will receive 3~     cycles of treatment at 21 day intervals. The aim of phase 1 is to estimate the recommended~     Phase II dose (RP2D) of MSCTRAIL in combination with pemetrexed/cisplatin chemotherapy.~      During the phase II study patients will be randomised to either the intervention or the~     control arm of the study. All patients in both arms will receive cisplatin and pemetrexed on~     day one of treatment. Patients randomised to the intervention arm will receive the~     recommended dose of MSCTRAIL from Phase I on day 2 whilst those in the control arm will~     receive a placebo. As this is a single blind trial patients will not know whether they are~     receiving MSCTRAIL or a placebo product but the clinical team will. The aim of phase 2 is to~     assess tolerability and preliminary efficacy of MSCTRAIL in combination with~     pemetrexed/cisplatin chemotherapy.~   "
20492|NCT03298750|"~     Examine the possibility that mechanical stimulation and ovarian fragmentation in women with~     premature ovarian failure or low ovarian reserve intended for egg donation may cause early~     follicular recruitment and increase chances of achieving pregnancy through IVF.~   "
20493|NCT03298737|"~     The purpose of this study is to provide information about how the brain processes sensory~     inputs using visual stimuli throughout various psychophysical experiments.~   "
20494|NCT03298724|"~     There are two aims of this study (a) to examine the effect of Teachers and Parents as~     Partners on student, parent, and teacher outcomes in middle school and (b) identify barriers~     and facilitators to implementing Teachers and Parents as Partners in middle school for~     students with behavior concerns.~   "
20495|NCT03298711|"~     For patients who underwent two-stage replacement of both knee joints (one knee surgery - one~     week term- the other knee surgery), postoperative pain and analgesic usage with~     patient-controlled analgesia (PCA) increased at the second stage, which suggests that central~     sensitization occurs within a short period (one week) in patients who undergo total knee~     arthroplasty (TKA). Neurosteroids act on NMDA and AMPA receptors, GABAa receptors, and~     voltage-dependent Ca2+ or K+ channels of sensory neurons to increase invasive or neuropathic~     pain and, conversely, to exhibit analgesic and anticonvulsant effects. These actions mean~     that the neurosteroid acts as an endogenous regulator of pain control and central~     sensitization. The purpose of this study is to confirm that the~     hypothalamus-pituitary-adrenal (HPA) axis, which is the main body of endocrine neurosteroid,~     is associated with increased pain sensitivity after TKA. The concentrations of cortisol and~     dehydroepiandrosterone (DHEA) in the saliva of patients who undergo two-staged bilateral knee~     replacement surgery (one knee surgery - one week term- the other knee surgery) will be~     measured at each stage and analyzed for correlation between concentration-related changes of~     HPA and postoperative knee pain variations.~   "
20496|NCT03298698|"~     This will be an open-label, randomized controlled trial which compares continued treatment~     with high dose prednisone (standard therapy) to treatment with rituximab in patients with~     minimal change disease or focal segmental glomerulosclerosis unresponsive to 8 weeks of high~     dose prednisone .~      patients either receive 2 doses of Rituximab 375 mg/m2 iv at time 0 and 14 days with~     termination of prednisone or standard therapy which consist of 8 additional weeks of high~     dose prednisone treatment.~   "
20497|NCT03298685|"~     prospective multicentric study protocol in french CF center, exploring adolescent avec~     parents needs during transition from pediatric CF center to adult CF center~   "
20498|NCT03298672|"~     This Phase 1 randomized, placebo-controlled, double-blinded, first-in-human study will~     evaluate safety, tolerability, and pharmacokinetics of single and multiple ascending doses of~     NDX-1017 in healthy young and elderly subjects, and elderly subjects with mild Alzheimer's~     disease or amnestic mild cognitive impairment (MCI).~   "
20499|NCT03298659|"~     In patients with acute ST-elevation myocardial infarction (STEMI), 40-60% have multi-vessel~     disease with an increased cardiovascular morbidity and mortality. Although it is not~     recommended to revascularize noninfarct lesions during the acute intervention, recent~     investigations suggest the opposite and show improved outcome after direct revascularization~     of noninfarct lesions. It is undesirable to risk procedure-related complications by treating~     noninfarct lesions without impaired flow. It is currently unknown whether pressure guided~     revascularization of noninfarct lesions in the acute phase improves outcome compared to the~     current guidelines.~      The iMODERN trial aims to compare an iFR-guided intervention of noninfarct lesions during the~     acute intervention with a deferred stress perfusion CMR-guided strategy during the outpatient~     follow-up, to determine the optimal therapeutic approach for STEMI patients with multivessel~     lesions.~   "
20500|NCT03298646|"~     Lidocaine Infusion On Hysteroscopic Media Versus Oral Diclofinac For Pain Relief During~     Outpatient Hysteroscopy. A Randomized Controlled Trial.~   "
20501|NCT03298633|"~     A multicenter, parallel-controlled(1:1 treatment ratio), double-blinded, randomized clinical~     trials regarding fertilization and pregnancy outcomes between ICSI and conventional IVF among~     couples with no-severe male-factor infertility in China.~   "
20502|NCT03298620|"~     Effect of electric toothbrush on oral hygiene in nursing home residents tested I randomized~     clinical trial for 2 months and followed up 12 months after baseline~   "
20503|NCT03298607|"~     The objective of the present study is to better define and evaluate Serelys PMS in terms of~     the impact on the different premenstrual syndrome (PMS) symptoms , tolerance, satisfaction~     and overall quality of life of women with known discomforts during the premenstrual period.~     The data from this study will be compared to data when the two different ingredients are~     given as monotherapy.~   "
20504|NCT03298594|"~     The main objective is to evaluate a specific cervicograph (the graph describing the cervical~     dilation, included in the partograph) for pregnant women with an history of cesarean section,~     to improve the management of labor for women attempting at a vaginal delivery (VBAC). Women~     will be randomly assigned to this specific cervicograph (including an action line 2 hours~     after the alert line), or to the normal cervicograph (no lines). The primary outcome is~     appropriate detection of dystocia.~   "
33164|NCT03132948|"~     The purpose of the study is to evaluate the impact of exercise on physical activity levels~     and quality of life in children with acute lymphoblastic leukemia (ALL) receiving maintenance~     chemotherapy.~   "
20506|NCT03298568|"~     DAOsin is a food supplement for special medical purpose for the treatment of food intolerance~     provoked by histamine intake. In this uncontrolled, interventional pilot study the effect of~     an oral diamine oxidase substitution (DAOsin) on the reduced endogenous diamine oxidase~     activity in histamine intolerant patients will be examined.~      Patients with a low endogenous diamine oxidase activity (below 10 Units/ml) take DAOsin for~     one month 3 times a day. During this month the diamine oxidase activity is tested biweekly.~     Afterwards a follow up period of one month without taking DAOsin follows. Again the diamine~     oxidase activity is tested biweekly.~   "
20507|NCT03298555|"~     Excessive gestational weight gain is a major public health problem. Traditional face-to-face~     intervention programs has been shown to be succesful in order to promote healthier weight~     gains, however, they are time-consuming and expensive. The objectives of this study are to~     assess whether a 6-month smartphone application can promote healthy gestational weight gain,~     dietary habits and physical activity in pregnant women.~   "
20508|NCT03298542|"~     The purpose of this study is to determine the safety and tolerability of golimumab in~     children, adolescents, and young adults with pre-symptomatic stage 2 type 1 diabetes mellitus~     (T1D).~   "
20509|NCT03298529|"~     The glycemic index (GI) compares the plasma glucose response to a specific amount of~     carbohydrates with the response induced by the same amount of carbohydrates from a standard~     carbohydrate source, pure glucose in our case. The GI is defined as the incremental area~     under the curve (iAUC) for blood glucose after consumption of a test food divided by the iAUC~     of a reference food containing the same amount of carbohydrates. GI is based on the~     physiologic functions of food carbohydrates rather than on their chemical structure, allowing~     to a more accurate classification. Several studies found that the regular consumption of low~     glycemic meals reduces the risk of developing diabetes, insulin-resistance, cardiovascular~     and neoplastic diseases.~      GI was originally developed for insulin-resistant subjects. The maintenance of stable blood~     glucose levels is a challenge for people with diabetes and pre-diabetes and is also~     beneficial for the general population, as reported by several studies.~      Low-GI diets have been shown to:~        -  stabilize blood sugar levels~        -  improve body weight~        -  better control appetite~        -  improve memory~        -  reduce the risk of cardiovascular diseases~        -  reduce the risk of some forms of cancer According to Walter Willet, nutrition researcher~          at the Harvard School of Public Health, an excess of sugars and refined starches~          stimulates insulin hypersecretion, hunger pangs and frequent snacking, slowing down~          lipid metabolism and making people physically less active.~      This project aims to evaluate the glycemic index of five different types of pasta with the~     same format, named Fettuccine, but with different composition (the pasta format is related~     to GI variations). The different types of pasta vary for flour and egg composition. However,~     having the same format, the GI will change only in response to the percentage content of the~     ingredients used to produce pasta. In particular, the aim is to measure egg's effect,~     distinct in yolk and white, on the glycemic and insulin response of healthy subjects.~   "
20510|NCT03298516|"~     This Phase Ia/Ib, open-label, multicenter study will evaluate the safety, tolerability, and~     preliminary efficacy of DCLL9718S as a single agent (Phase Ia, Arm A) in participants with~     relapsed or refractory AML or in combination with azacitidine (Phase Ib, Arm B) in~     participants with previously untreated AML who are not eligible for intensive induction~     chemotherapy. Each arm will consist of two stages: a dose-escalation stage and an expansion~     stage. The dose-escalation stage is designed to establish the maximum tolerated dose (MTD)~     and recommended Phase II dose (RP2D) for DCLL9718S alone (Arm A) or in combination with~     azacitidine (Arm B). The dose-expansion stage is designed to characterize the long-term~     safety and tolerability of DCLL9718S.~   "
20511|NCT03298503|"~     Postural-suprapostural task is defined as postural control takes place while at least one~     other concurrent task is being performed. In a postural-suprapostural task, appropriate~     prioritization of is necessary to achieve task goals and maintain postural stability.~     Therefore, regarding to impose task prioritization in a postural-suprapostural task, the~     optimal task-priority strategy for PD patients is still an issue of debate. With the uses of~     EEG, EMG and behavioral measures, the purpose of this project is to investigate the~     differences in performance quality and intrinsic neural mechanisms of a~     postural-suprapostural task for PD patients, by adopting posture-focus and~     suprapostural-focus strategies during standing and walking. The present project is expected~     to have significant contributions not only to gain a better insight to neural correlates of~     concurrent postural and suprapostural tasks with different task prioritization under standing~     and walking, but to optimize treatment strategy for PD patients with balance or dual-tasking~     disturbances.~   "
20512|NCT03298490|"~     In this study, we performed the validity and reliability of the Turkish version of Back~     Performance Scale.~   "
20513|NCT03298477|"~     Prospective, multicenter, single arm study with consecutive, eligible subject enrollment at~     each site. All subjects will undergo the Endovascular Aneurysm repair procedure with the~     Nellix System.~   "
20514|NCT03298464|"~     The purpose of the study is to evaulate the safety, tolerability, and efficacy of NGM313 in~     obese participants~   "
20515|NCT03298451|"~     This is a randomized, open-label, multi-center, global, Phase III study to assess the~     efficacy and safety of durvalumab plus tremelimumab combination therapy and durvalumab~     monotherapy versus sorafenib in the treatment of patients with no prior systemic therapy for~     unresectable HCC. The patients cannot be eligible for locoregional therapy.~   "
20516|NCT03298438|"~     Neurofibromatosis type 1 (NF1) is one of the most common autosomal dominant genetic~     disorders. The aim of our study was to evaluate post-traumatic stress disorder (PTSD) in~     patients and their families following the disclosure of sporadic NF1. Diagnosis of NF1 was~     retained according to NIH criteria, familial forms were excluded. The French version of the~     Impact of Event Scale-Revised was used for the diagnosis of PTSD.~   "
20517|NCT03298425|"~     The purpose of the study is to investigate if using an electrical stimulation machine to see~     if it can help strengthen the muscles around the hip during the first three months post~     pelvic fracture will help with the early stages of rehabilitation. Electrical stimulation is~     a treatment machine that uses an electrical current to cause a single muscle or a group of~     muscles to contract. This contraction helps strengthen injured muscles and helps with the~     healing process. It can also help with pain relief by blocking pain signals from the brain.~      After a pelvic fracture they are surgically fixed and will be advised not to put any weight~     on the operated leg for 10 weeks. During this time hip muscles become very weak as they will~     not be used as much as normal. Bed exercises can help keep muscle strength but this study~     would like to try using electrical stimulation machines alongside bed exercises to see if it~     can improve muscle strength even more. Electrical stimulation machines are already used by~     rehabilitation. Electrical stimulation is a treatment machine that uses an electrical current~     to cause a single muscle or a group of muscles to contract. This contraction helps strengthen~     injured muscles and helps with the healing process. It can also help with pain relief by~     blocking pain signals from the brain.~      After a pelvic fracture they are surgically fixed and will be advised not to put any weight~     on the operated leg for 10 weeks. During this time hip muscles become very weak as they will~     not be used as much as normal. Bed exercises can help keep muscle strength but this study~     would like to try using electrical stimulation machines alongside bed exercises to see if it~     can improve muscle strength even more. Electrical stimulation machines are already used by~     patients to increase muscle strength.~      Participants will be put into one of two groups, both groups will be given an electrical~     stimulation machine but one will be on a placebo setting. Participants will need to use the~     machine twice a day along with their bed exercises and will need to fill in a diary when and~     how many times the machine has been used for 10 weeks until their 12 week appointment with~     the orthopaedic consultant. The participants weight bearing status will change and they will~     be asked to perform a muscle strength test on both the operated and nonoperated leg. They~     will also have their walking quality assessed. The results will compare both groups for~     muscle strength and walking changes.~   "
33224|NCT03132142|"~     The purpose of this study is to investigate the potential desensitising effects of repeated~     applications of capsaicin, trans-cinnamaldehyde and L-menthol on thermal, mechanical and~     chemical sensory stimulations.~   "
20519|NCT03298399|"~     This trial is being conducted as a step toward testing the long-term hypothesis that freshly~     cultured, autologous mesenchymal stromal cells (MSCs) grown in platelet lysate-containing~     medium will modulate recipient T-cell immune responses and promote engraftment in~     haploidentical hematopoietic cell transplant (HCT) recipients. As a phase I, dose escalation~     trial of autologous MSCs in patients with sickle cell disease (SCD) undergoing haploidentical~     HCT, the main aim is to evaluate the safety of this therapy with a secondary aim to evaluate~     its effects on engraftment and graft-versus-host disease (GVHD).~   "
20520|NCT03298386|"~     The general practitioner (GP) is confronted, for a part of his clientele, with the management~     of patients suffering from multimorbidity, leading most often to a polypharmacy. It has five~     major consequences: increasing the number of inappropriate treatments, increasing the risk of~     potentially dangerous drug interactions, increasing the risk of contraindications associated~     with several concomitant pathologies, decreasing adherence to treatments by patients and the~     increased cost of care. Drug misuse in the elderly is particularly common, due to the~     age-related physiological changes and physiological alterations, with the consequent increase~     in the risk of adverse events, particularly hospitalizations. Several tools have been~     proposed to decrease morbimortality in elderly patients with polypharmacy. The studies~     concluded that the STOPP/START tool was the most structured, sensitive and had the most~     appropriate use format for clinical practice. However, there are currently no ambulatory~     studies demonstrating the impact of prescription revision with STOPP/START on the~     morbimortality of persons aged 75 years and over. This study aims to assess the effectiveness~     of an intervention targeting GPs to decrease morbimortality in elderly patients with~     polypharmacy. Volunteer GPs will be randomly assigned to either the intervention group or to~     usual care (control group) and they will be followed one year. The intervention consists in~     systematic medication review by GP with STOPP/START. In both groups, patient morbimortality~     will be measured at the end of the study.~   "
20521|NCT03298373|"~     This is a Phase I multicenter, double-blind, repeat dose, dose-escalating study, in healthy~     men to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of 11-β~     Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC).~   "
20522|NCT03298360|"~     To analyze the HIV viral sequences present in the CD32 + CD4a + T lymphocytes of the patients~     who have participated in the ANRS 139 TRIO trial, always followed and in virological success,~     and carrying multi-resistant viruses archived in the HIV cell reservoir, in order to~     reconstruct the chronology of the installation of this reservoir.~   "
20523|NCT03298347|"~     Nowadays,caffein is commonly used for AOP, and it reduces the intubation rate in preterm~     infants. However, intubation is needed in about 20%-50% of partial neonates. How to reduce~     the intubation rate effectively is a challenge for neonatologists.~   "
20524|NCT03298334|"~     Neonates delivered by scheduled Cesarean Section will be randomized to receive vaginal~     seeding (exposing the infant to Mother's vaginal flora) or sham. Infants will be followed for~     three years to examine health outcomes including microbiome development, immune development,~     metabolic outcomes, and any adverse events.~   "
20525|NCT03298321|"~     Genomic studies on atrial fibrillation patients have identified polymorphisms in regions~     surrounding the PITX2 gene, suggesting it could be the locus responsible for atrial~     fibrillation. The PITX2 gene is essential for establishing the asymmetry between systemic and~     pulmonary blood flow, which is absolutely required for proper heart functions. In addition,~     PITX2 is required for the development the atrium myocardium. Investigators have performed~     transcriptomic analysis on left atrium tissues from atrial fibrillation patients and identify~     genes whose expression is altered in atrial fibrillation. Among affected genes, PITX2~     expression is strongly decreased in the left atrium of atrial fibrillation patients.~     Moreover, investigators observed that the PITX2 promoter region is hypermethylated in atrial~     fibrillation patients. Interestingly, DNA methylation is a key actor of gene expression and~     directly regulates RNA transcription either by directly modulating transcription factor (TF)~     binding to gene promoters or by modifying local chromatin structures, therefore limiting~     access of TFs to DNA. These epigenetic modifications are reversible and therefore represent~     an interesting therapeutic target. Hence, many compounds that inhibit DNA methyl-transferase~     are currently tested in different disease models. Recently-designed hypomethylating molecules~     are available, such as the 5'azacytidine (Vidaza®, Celgen Inc.) or the 5-aza-2'-deoxycytidine~     (Decitabine) (Dacogen®, Janssen Cilag). Investigators have performed preliminary studies on~     the effect of Decitabine on DNA methylation and proper cardiac function recovering in a SHR~     model. Results indicate that the chronic delivery of Decitabine improves the arrhythmia~     profile by reducing tachyarrhythmia, fibrosis, as well as the oxidative stress in SHR left~     atrium submitted Acute Leukemia is a rare pathology with an incidence of 4 per 100,000 in~     France. Azacytidine, which is closely related to Decitabine, is commonly used for treating~     Acute Leukemia and possesses anti-neoplastic effect through multiple mechanisms, including~     direct cytotoxicity of blood cancer cells and DNA hypomethylation. The goal of this study is~     to evaluate the effects of azacytidine on arrhythmia and left atrium fibrosis as well, which~     are the two mains phenotypic manifestation of atrial fibrillation in humans. Investigators~     hypothesize that azacytidine decreases PITX2 promoter methylation and increases PITX2~     expression. Hence, investigators expect to ameliorate the duration of atrium action potential~     and to observe a decrease of atrium fibrosis.~   "
20526|NCT03298308|"~     This pilot study explored relationships between cranial electric stimulation and brainwave~     changes.~   "
20527|NCT03298295|"~     In insulin pump therapy, insulin is continuously infused into the subcutaneous adipose tissue~     via a continuous subcutaneous insulin infusion (CSII) catheter using a basal/bolus pattern.~     Unfortunately, insulin absorption from the tissue surrounding a CSII catheter can be slow,~     variable, and unreliable. It is recommended to replace CSII catheters after 2 to 3 days of~     use. Frequently changing the injection site can be tedious and moreover leads to scarring,~     while reusing the same injection site can lead to medical complications such as~     lipohypertrophy. CSII catheters are manufactured from both steel and Teflon and use of either~     of these materials is based on personal preference/experience rather than scientific,~     empirical data. We hypothesize that the inflammatory response to CSII catheters is a major~     contributor to variable insulin absorption and that this response is significantly different~     between materials and catheters shapes. In order to develop CSII catheters with an extended~     life-time up to 7 days, we need to better understand the inflammatory response caused by the~     introduction and maintenance of a CSII catheter into the subcutaneous adipose tissue. This~     study is a pilot study in humans scheduled for elective plastic surgery where a large skin~     flap is removed from the abdominal region. Teflon and steel CSII catheters will be inserted~     into the abdomen 7, 4, and 3 days prior to surgery. This study design allows for the removal~     of tissue plugs surrounding CSII catheters without causing additional scarring for the~     patient.~   "
20528|NCT03298282|"~     The coronary images of selective angiography and optical coherence tomography with~     FFR(Fractional Flow Reserve) values of the intermediate lesions (50-70% stenosis) will be~     prospectively registered.~   "
20529|NCT03298269|"~     The purpose of this study is to examine the effects of Mindfulness-Oriented Recovery~     Enhancement versus a social support group (supportive counseling) intervention for chronic~     pain patients receiving long-term opioid pharmacotherapy for pain.~   "
20530|NCT03298256|"~     This study intends to investigate the three dimensional (3D) effect of bracing on the~     adolescent idiopathic scoliosis (AIS). In particular, it will look at the relationship~     between frontal deformity correction and changes in the sagittal profile and apical vertebral~     rotation (AVR) during bracing. The investigators hypothesise that if the thoracic frontal~     deformity can be controlled with bracing, there will be spontaneous correction of the~     sagittal plane and rotation deformity through coupling.~   "
20531|NCT03298243|"~     Supplementing or augmenting sensory information to those who have lost proprioception after~     stroke could help improve functional control of the arm. Twenty-eight subjects will be~     recruited to a single site to evaluate the ability of various forms of vibrotactile~     stimulation to improve motor function, and to determine which locations of stimulation may~     optimize function. Participants will be tested in performing reaching movements and~     stabilization movements as well as more functional tasks such as simulated drinking from a~     glass~   "
20532|NCT03298230|"~     Peripheral arterial disease affects around 25% of the UK population aged over 55. Left~     untreated it can lead to debilitating pain, gangrene, amputation and death. It most commonly~     affects the lower limbs and in the earlier stages of the disease patients can present with a~     symptom known as intermittent claudication; pain felt in the legs which stops the patient~     from walking past a certain distance. Current National Institute for Healthcare and~     Excellence (NICE) guidelines recommend Supervised Exercise as first line treatment for~     patients with peripheral arterial disease presenting with intermittent claudication.~     Supervised exercise employs behaviour changing techniques which enable the patient to modify~     their lifestyles, improving their claudication symptoms, quality of life and reducing their~     cardiovascular risk. Despite this treatment being significantly more cost-effective than~     often employed complex endovascular management, most institutions don't offer such programmes~     citing lack of resources and compliance from clinicians and patients alike.~      The investigators propose a more cost-effective, resource-savvy solution in the form of~     REmotely SuPervised ExerCise Training (RESPECT). This allows the patient to exercise in the~     convenience of their own home, at a time of their choosing but still be supervised via~     fitness tracker technology and an online fitness platform. This randomised controlled trial~     will attempt to prove its' effectiveness in increasing claudication distance, improving~     functional ability, decreasing cardiovascular risk and improving quality of life whilst being~     more cost-effective than the currently recognised national first line treatment. This trial~     has the potential to revolutionise the management of patients with peripheral arterial~     disease.~   "
20533|NCT03298217|"~     This aim of this study is to measure the peak tidal inspiratory flow (PTIF), using~     spirometry, in young infants with moderate to severe acute viral bronchiolitis (AVB).~      PTIF is important to consider for the management of AVB with High Flow Nasal Cannulae (HFNC).~     Indeed, efficiency with HFNC is optimal provided that the settled flow is equal or higher~     than the patient's PTIF. However, PTIF values in infants with AVB have never been determined.~   "
20534|NCT03298204|"~     The aim of this observational study is to retrospectively collect survival data for 3000~     primary esophageal cancer patients from multicenter between January 2000 to present. Based on~     a Cox model, we want to develope a nomogram that predicts local recurrence, distant~     metastases, and survival for patients treated with radiotherapy or chemoradiotherapy with or~     without chemotherapy.~   "
20535|NCT03298191|"~     Preterm birth is defined as birth before 37 completed weeks of gestation .it occurs in~     11.1%of birth globally affecting an estimated 14.9 million babies every year . It is~     generally accepted that approximately 65%-70%of preterm births are spontaneous,40%-45% of~     them due to spontaneous preterm labor and 25%-30%following preterm rupture of~     membranes.preterm birth represents the single largest cause of morbidity and mortality for~     newborn and is estimated for 29%of deaths in the first four weeks of life and also is~     estimated for of major cause of morbidity for pregnant women .~      Tocolytic agents include a wide range of drugs that can slow or suppress uterine contractions~     . Tocolytic are considered advantages in spontaneous preterm labor to : (a) allow time for~     the fetus to mature ,potentially avoiding deleterious effects of pre-maturity . (b)allow time~     for antenatal corticosteroids to be administered and have clinical effect. (c) allow time for~     intrauterine transfer to higher-care center where neonatal intensive care facilities are~     available . the ideal Tocolytic agent should be effective , easy to administer , without~     significant material ,fetal or neonatal side effects and permit time for antenatal~     corticosteroids to be administered and take effect . a variety of Tocolytic treatments have~     been used to inhibit uterine activity in women in spontaneous preterm labor , including~     betamimetics , calcium channel blockers , magnesium sulfate , prostaglandin inhibitors and~     oxytocin receptor antagonists however there is considerable global variation in types , doses~     and regimens of tocolytic agents uses to manage preterm labor .~      A comparison study between Ritodrine, magnesium sulfate and Nifedipine in terms of effect and~     morbidity will be conducted.~   "
20536|NCT03298178|"~     This study evaluates the effectiveness and safety of surgical aortic valve replacement and~     transcatheter aortic valve replacement in aortic Stenosis.~   "
20537|NCT03298165|"~     This study will be conducted to assess antibacterial effect of the diode laser in deep~     carious cavity after step wise excavation using the bacteriological assessment method.~   "
20557|NCT03297905|"~     This study will (1) compare the effectiveness of standard rehabilitative pain care with~     complementary and integrative pain therapies; (2) identify subgroups of patients who do and~     do not respond to the intervention(s); (3) determine the most effective sequencing of the~     interventions; and (4) determine factors associated with treatment response that can be~     implemented to support clinical decision-making.~   "
20558|NCT03297892|"~     Cushing's disease is a rare disease that can reduce patients' expectations or quality of~     life, and for which predictive factors for cardiovascular mortality and recurrence are not~     well defined.~      The primary objective is to determine the rates of remission and recurrence of patients with~     Cushing's disease diagnosed between 1990 and 2015 in the French region of the West (Angers,~     Brest, Nantes, Rennes, Poitiers , Tours) focusing on remission particularly at two periods :~     that after the first pituitary surgery and that on the day of the last news.~      The secondary objective is to study the possible prediction of clinical and biological data~     perioperative of remission and recurrence during follow-up.~   "
20559|NCT03297879|"~     The present study assessed the therapeutic effect of exenatide and metformin as the initial~     therapy in overweight/obese patients with newly diagnosed Type 2 diabetes (T2D).~   "
20538|NCT03298152|"~     Nowadays Endocrowns are classified as conservative treatment modality for restoration of~     Endodontically treated teeth in which pulp chamber is used as a retentive resource.~      With the advancement in technology in the field of adhesive dentistry its use is increasing~     day by day in clinical practice. Acid Etchable ceramics such as lithium Disilicate based~     ceramics are the gold standard ceramic material used for Endocrowns. The Etchable property~     and the translucent character of lithium Disilicate enhance strength and esthetic property.~      A new material CERASMART (Force Absorbing Flexible nano ceramic CAD/CAM block) contain high~     density of ultrafine glass particles with 71 wt% filled nano-composite. It combines high~     strength and unique aesthetics. full homogeneous and even distribution of nano ceramic~     network lead to unique physical properties for cerasmart . Uniform scuttle (very short~     inter-particle distance) of silanated and bonded particles is key to delivering CERASMART's™~     with high strength and acceptable level of marginal adaptation.~      So, it can perfectly use in posterior, anterior, inlay, onlay, and implant restorations and~     also enables minimum tooth reduction for more conservative restoration.~      Awad et al (1) found that Cerasmart showed significantly higher flexural strength and modulus~     of elasticity, with lower flexural modulus values compared to other groups. Also, result in~     smoother margins compared with other types of ceramic.~      So, present research will evaluate patient satisfaction, bonding properties and marginal~     adaptation~   "
20539|NCT03298139|"~     Although most ground studies showed that an egocentric reference frame better supports~     spatial orientation, it is not proven it will be the same during weightlessness.~      Although it might justify that visuomotor performance will be better supported by egocentric~     target cueing under altered gravity conditions, the fact that exocentric target cueing~     induces less head movements and called for least attentional and physiological workload could~     be the key factors for a more efficient task localization process. Moreover, weightlessness~     can induce spatial disorientation, which can be additionally influenced by the intrinsic and~     extrinsic spatial reference frames (Gurfinkel et al., 1993; Glasauer & Mittelstädt, 1997,~     1998; Harm et al., 1998; Lipshits et al. 2005). We expect that during weightlessness the~     workload will be the key factor and thus we hypothesize that an exocentric target cueing will~     outperform egocentric target cueing.~      To test this hypothesis, and find out which presentation scheme for target cueing (EGO, EXO,~     ED) contributes most to an efficient visual search, performance to a visuomotor task will be~     evaluated during parabolic flights in normogravity (1g), hypergravity (1.8g) and microgravity~     (0g). The visuomotor performance will be assessed by a multi-directional tapping task as~     defined by ISO9241-9, which requests for motor responses by aimed pointing movements. Besides~     analyzing the pointing performance, different workload indices will be additionally assessed~     to evaluate the effort spent on visuomotor coordination. The attentional workload will be~     evaluated by the performance of a secondary task (visual reaction-time task), which needs to~     be conducted in parallel to the visuomotor task. Furthermore, the workload will be also~     assessed subjectively by the NASA TLX rating scale and physiologically, by analyzing the~     heart rate variability (HRV).~   "
20540|NCT03298126|"~     Coronary artery disease (CAD) is one of the major health concerns among other~     non-communicable diseases globally. Cardiac catheterization is a diagnostic gold standard to~     determine the extent of disease in coronary arteries due to atherosclerosis. Among the two~     approaches for cardiac catheterization, trans-radial approach has gained more popularity than~     conventional trans-femoral approach over the past decade with availability of compression~     devices for radial artery that assures lesser risk of bleeding and hematoma and has~     translated into increased patient comfort and early mobility post procedure. Radial artery~     occlusion is a common complication of trans-radial procedures often ignored by the operator~     after procedure due to dual blood supply by ulnar artery. Although clinically silent usually,~     it necessitate the need of monitoring radial artery for patency because of risk of limited~     trans-radial access later.Reportedly, RAO occurs in about 10% of cardiac catheterizations. ,~     compression devices applied after sheath removal may be a contributing factor to radial~     artery occlusion because of selective pressure for extended time duration (3-4 hours).~     Various protocols have been developed to remove TR band by different institutions across the~     globe and have been tested to assess post procedure complications. To the best of what we~     know, there exists no standard protocol to deflate TR band. Also, the current protocol in~     practice at our institution has not been evaluated against other protocols that are followed~     in other institution across the globe claiming lesser post procedure complications. Hence,~     our aim was to test through a randomized trial whether our hospital standard protocol is~     non-inferior to the existing international protocol of Cohen & Alfonso that promises lesser~     complication rate~   "
20541|NCT03298113|"~     The purpose of the clinical study is to assess the effects of 3M Cavilon Advanced Skin~     Protectant in comparison to different local IAD care regimes in hospitals (IAD:~     Incontinence-associated Dermatitis)~   "
20542|NCT03298100|"~     A prospective cohort study to assess RHEA ( recurrent vaginal bleeding, hypertension,~     endometrial thickness and age) scoring model for prediction of endometrial carcinoma~   "
20543|NCT03298087|"~     This is a trial for patients with newly diagnosed metastatic prostate cancer with 5 or fewer~     sites of metastases. The trial involves surgery (removal of the prostate), six months of~     hormone therapy, and stereotactic body radiotherapy to the sites of metastasis.~   "
20544|NCT03298074|"~     It is a prospective multi-center trial, platinum-resistant ovarian cancer patients will be~     randomized in two groups, one group will be treated with Apatinib plus Etoposide, the other~     will be treated with Etoposide alone. It is aimed to see the efficacy and safety of Apatinib~     plus Etoposide for the platinum-resistant ovarian cancer patients~   "
20560|NCT03297866|"~     Aim to test the effectiveness of different incentive models for increasing the follow-up~     response rate in the current smoker subject.~   "
20561|NCT03297853|"~     The demand for addiction care for patients with addiction to analgesics increases with the~     number of prescription of analgesics grade 2; this is a public health problem There is no~     support for repositories to date in the context of addiction analgesics grade 2.~      Risk factors of misuse as well as diagnostic tools were identified.~   "
20562|NCT03297840|"~     The current study aims to investigate the effect of dialectical behavioral therapy on~     mindfulness in patients with Borderline Personality Disorder. A treatment group will be~     compared to a waitlist control group.~   "
20572|NCT03297710|"~     This phase I trial studies the side effects and best dose of trifluridine/tipiracil~     hydrochloride combination agent TAS-102 (TAS-102) when given together with radiation therapy~     in treating patients with rectal cancer that has come back, spread to other places in the~     body, or cannot be removed by surgery. Drugs used in chemotherapy, such as TAS-102, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy~     x-rays to kill tumor cells and shrink tumors. Giving TAS-102 with radiation therapy may kill~     more tumor cells.~   "
20545|NCT03298061|"~     Eosinophilic Granulomatosis with Polyangiitis (EGPA), also referred to as Churg-Strauss~     syndrome, is a rare hyper-eosinophilic syndrome. Eosinophilia is central to the~     pathophysiology of EGPA and interleukin-5 (IL-5) is a key cytokine regulating the life-cycle~     of the eosinophil. Neutralization of IL-5 with mepolizumab, an anti-IL5 monoclonal antibody,~     therefore offers a potential therapeutic option for EGPA. The objective of study MEA115921~     was to investigate the efficacy and safety of mepolizumab compared with placebo wherein the~     subjects were randomized to receive either: 300 milligram (mg) mepolizumab or Placebo~     subcutaneous (SC) injection every 4 weeks in addition to their background standard-of-care~     therapy. Subjects were treated for a period of 52 weeks and then followed up for a further 8~     weeks to study completion at Week 60. This is a LAP to support provision of open-label~     mepolizumab on an individual basis to eligible subjects who participated in clinical study~     MEA115921 and who require a dose of prednisolone (or equivalent) of >=5 milligrams per day~     (mg/day) for adequate control of their EGPA. Eligible subjects can initiate mepolizumab under~     this LAP within a 6-month period starting from completion of study MEA115921 (that is, at~     Week 60) or, in case of premature discontinuation from study MEA115921, the subjects will~     initiate mepolizumab at the time point that would have been Week 60 if the subject had~     completed the study. Eligible subjects will receive subcutaneously administered mepolizumab~     at a dose of 300 mg SC every 4 weeks. Eligible subjects will continue to receive mepolizumab~     under this LAP until mepolizumab is commercially licensed for the treatment of EGPA in the~     relevant country or until GlaxoSmithKline (GSK) discontinues the program or until the subject~     meets any of the withdrawal/stopping criteria.~   "
20546|NCT03298048|"~     To establish optimal dosing of lyophilized FMT product in the treatment of recurrent C.~     difficile infection~   "
20547|NCT03298035|"~     The purpose of this study is to determine whether nasal intermittent positive pressure~     ventilation (NIPPV) reduces the need for endotracheal intubation in very low birth weight~     infants with persistent apnea who fail nasal continuous positive airway pressure (NCPAP).~   "
20548|NCT03298022|"~     To evaluate the efficacy and safety of Neihulizumab (AbGn-168H) administered intravenously in~     patients with moderate to severe active ulcerative colitis who are refractory or intolerant~     to anti-Tumor Necrosis Factor α and/or anti-integrin treatments.~   "
20549|NCT03298009|"~     It is a mechanistic proof-of-concept study to demonstrate how SGLT-2 inhibitors~     (Canagliflozin) may have a beneficial role on cardiac energetic efficiency.~      Patients with type 2 diabetes and with HF diagnosed for at least 3 months will be selected.~     The participants will be randomized to a double-blind, crossover 2-week placebo vs. Cana 100~     mg once daily, an interventional trial with a one-month washout period in between.~      At the term of the two-week placebo and canagliflozin treatment periods (visits 2 and 4),~     each participant will undergo an identical postprandial metabolic study with positron~     emission tomography (PET) and stable isotopic tracer methods.~   "
20550|NCT03297996|"~     Gut microbiota were assessed in 540 colonoscopy-screened adults by 16S rRNA gene sequencing~     of stool samples. Investigators compared gut microbiota diversity, overall composition, and~     normalized taxon abundance among these groups.~   "
20551|NCT03297983|"~     This is a Phase I study consisting of 2 parts: Part 1 aims to investigate the relative~     bioavailability of tablet formulation (test treatment) and Powder in capsule (PiC)~     formulation (reference treatment) of M7583 under fasted conditions. The aim of Part 2 is to~     determine and compare the single dose Pharmacokinetic (PK) profile of M7583 tablet under~     fasted and fed conditions to assess the food effect.~   "
20552|NCT03297970|"~     This observational study investigates the associations of nutritional indicators, biomarkers,~     sociodemographic conditions, and infections with child health, as well as physical,~     behavioral, and cognitive development. Investigators recruited a random sample of 3202~     children from primary public schools in Bogota, Colombia in February 2006 and followed them~     for a median of 6.5 years. Investigators hypothesized that poor nutritional status at the~     time of recruitment in middle childhood would be related to adverse health outcomes through~     adolescence.~   "
20553|NCT03297957|"~     Fluorescent technology continues to advance in the detection of sentinel lymph nodes (SLNs).~     Currently, this requires switching from near-infrared light to white light to be able to~     identify the fluorescent tissue contrasting with normal surrounding tissue. Currently, no~     system has been studied specifically for head and neck sentinel lymph node biopsies using a~     hands free goggle system that can visualize white light (normal surgical visualization) and~     nearinfrared light (ICG fluorescence) simultaneously. This technology may have implications~     on the safety and accuracy of sentinel lymph node biopsy for head and neck mucosal and~     cutaneous tumors. Secondarily, this may reduce operative costs by decreasing the amount of~     time required to perform the SLNB procedure.~   "
20554|NCT03297944|"~     This study evaluates the effect of anxiety drugs taken at night on the ability to drive a car~     the next day. Participants will receive alprazolam, placebo, or zolpidem at night before bed~     or in the morning before using a driving simulator to assess impairment.~   "
20555|NCT03297931|"~     Consumers are often forced to eat fast, convenient foods and snacks (eat on the go) in~     order to match the pace of their lifestyles. However, these snack options more often than not~     offer little health benefit to the consumer. In fact, 55% of calories consumed by Canadians~     are ultra processed foods, which are limited in their nutrient profile and only offer empty~     calories. Subsequently, these foods lead the consumer to eat more and provides little to no~     feelings of satiety or satiation. the proposed objectives of the current project are to~     examine the physiological benefit(s) of consuming readily available pulse snacks and compare~     them to other commonly consumed snack varieties. This work aims to incentivize consumers to~     seek out pulses as valuable snacking options and highlight the benefit of including these as~     alternatives to other energy-dense snacks that lack the nutritional composition of pulses.~   "
20556|NCT03297918|"~     Most patients with complex congenital heart disease and cardiomyopathy from acquired heart~     disease have reduced exercise capacity. Exercise capacity is associated with respiratory~     muscle strength and function. If structured respiratory muscle training positively influences~     respiratory muscle function in patients with structural heart disease is not well known. The~     aim of this study is to investigate whether regular singing lessons and breathing exercises~     improve respiratory muscle strength in patients with congenital or acquired structural heart~     disease.~   "
20563|NCT03297827|"~     Various molecules (cytokines: interleukins, interferons and neural proteins) found in human~     and animal blood are reported to be elevated in acute stroke (Ischemic and hemorrhagic).~     Cytokines can be pro-inflammatory or anti-inflammatory. There are studies confirming level~     changes in serum of humans in the setting of several rheumatologic and cardiovascular~     diseases. As new molecular markers (cytokines and neural tissue markers) are established in~     scientific literature, stroke scientists are interested to evaluate the role of these in the~     pathophysiology of stroke. Investigators intend to study the role of these molecules in the~     development of stroke.~      Acute stroke treatment has advanced considerably in the last 10 years with the establishment~     of comprehensive stroke centers and approval of neuro-interventional techniques. However, the~     molecular advancement in stroke pathogenesis has yet to reach a milestone in the world of~     stroke treatment. In our opinion, creating a database of acute stroke patients containing all~     pertinent medical demographics and clinical information along with the laboratory data,~     molecular levels of pertinent cytokines/neural factors from consenting patients, will help us~     define and delineate the most relevant molecules that are altered in acute stroke patients~     and can help us further improve us understanding of the role of these in acute stroke and~     thereby hopefully help in the improvement of our understanding and management of stroke.~     Moreover, analyzing the cytokines in stroke and ICH patients would help understand their role~     in the acute phase, which may become potential therapeutic adjuncts for tPA and endovascular~     thrombectomy.~   "
20564|NCT03297814|"~     Allogenic platelet lysate will be injected in the gastrocnemius of patients with peripheral~     arterial disease (PAD)~   "
20565|NCT03297801|"~     Prenatal supplementation with fish oil, rich in omega-3 polyunsaturated fatty acids, is~     widely recommended in Canada. The aim of this observational, prospective cohort study is to~     determine the effects of maternal fish oil supplements on the development of their infants'~     gut microbiota and immunity.~   "
20566|NCT03297788|"~     Patients suffering from small cell lung cancer (SCLC) are at high risk for developing brain~     metastases (BM). To prevent a clinical manifestation of preexisting microscopic brain~     dissemination, prophylactic cranial irradiation (PCI) is offered to both limited and~     extensive disease patients, if they respond to first line regime, thus being at risk or at~     chance to develop clinical brain metastases. However, up to 10-15% of patients present with~     BM at initial diagnosis. If MRI is used as a diagnostic tool for initial staging the number~     even increases up to 15-20%. Additionally, between 40 - 50% of patients develop BM until time~     of death and the risk of developing BM further increases with prolonged survival. Treatment~     options are usually limited to WBRT and palliative chemotherapy but the actual effect of~     therapeutic WBRT has mainly been studied in small retrospective and nonrandomized studies.~     WBRT has been established as the treatment standard in patients with cerebral metastases from~     SCLC, however, it has only modest efficacy. Results might be improved by additional dose~     escalation. A SRS to cerebral metastases may be indicated in patients with intracranial~     disease, and the current protocol is aimed at exploring the neurocognition and efficacy of~     SCLC in patients with brain metastases treated with SRS or WBRT.~      The present trial aims to exploratory investigate the treatment response to ´conventional~     whole brain radiotherapy´ (WBRT) and ´stereotactic radiotherapy´(SRS) in SCLC patients.~   "
20567|NCT03297775|"~     The overall goal of this study is to define the phenotype of Interstitial Lung Disease (ILD)~     in patients with rheumatoid arthritis (RA). The investigators hypothesize that there are~     common elements between other forms of ILD such as idiopathic pulmonary fibrosis (IPF) and~     sub-clinical RA-ILD that places individuals at risk for the development of lung disease.~      This is not a treatment study. It is a protocol designed to enroll individuals affected by RA~     and explore associated lung disease so that the investigators can better understand the~     clinical phenotype and genetic and molecular endotypes of this disease.~   "
20568|NCT03297762|"~     To use an enhanced continuous glucose monitor (CGM) experience, including an automated~     CGM-electronic health record (EHR) data integration system, proactive interventions, and~     gamification techniques, to increase CGM use among publicly-insured youth with type 1~     diabetes (T1D).~   "
20569|NCT03297749|"~     The aim of this study is to investigate the systemic impact of periodontitis in patients with~     Metabolic Syndrome, by assessing measures of sub-clinical atherosclerosis and cardiovascular~     risk, microbial factors and host genetic variants, and to study the possible effect of~     mediators of inflammation and oxidative stress as links between the two conditions.~   "
20570|NCT03297736|"~     Prospectively analyze the use of 3D subtraction CAD/CAM in the operating room environment.~     Study participants, requiring middle ear surgery and ossicular reconstruction, will be~     implanted with one of two middle ear implants. The rationale is to complete a pilot study of~     the technology with a small number of designs. Each implant will be commonly used, in the~     public domain, and recreated by the CAD/CAM software.~   "
20571|NCT03297723|"~     Pain is one of the most feared and burdensome symptoms experienced by cancer patients. Its~     prevalence has been estimated by INCa1 in 2012 at 48% in patients undergoing cancer~     treatment, and unrelieved pain is directly associated with significantly reduced quality of~     life (QoL)2. A large part of cancer pain undertreatment can be attributed to patient-related~     barriers. Patient barriers are multifactorial and often result from a lack of knowledge about~     cancer pain and its self-management. They mainly consist of misconceptions about opioids and~     their side effects, nonadherence, and reluctance to alert health care providers to unrelieved~     pain. Patient education enables people with chronic disease to manage their illness, and has~     been considered in the field of cancer research as an important strategy to achieve optimal~     pain control.~      In Basse-Normandie french region, the Health Regional Plan, pain aspect has identified the~     theme  pain education program  as a priority.~      The main endpoint is the decrease of pain interference with daily life (using the Brief Pain~     Inventory). The experimental group, consisting of cancer pain patients, will benefit from the~     education program by previously trained health care providers. It will be compared with the~     control group, consisting with patients whose pain will be conventionally managed before the~     professional training in therapeutic education.~   "
20976|NCT03292445|"~     This research study is to determine if donor blood stem cells given after living, related,~     HLA antigen (Ag) haplotype match or living, unrelated, 3 HLA antigen matched (HLA-A, -B, and~     -DR) donor kidney transplantation will change the immune system such that immunosuppressive~     drugs can be completely withdrawn or reduced to minimal dose without kidney rejection.~   "
20573|NCT03297697|"~     As T-cell receptor sequencing by LymphoTrack is an assay with high sensitivity that can be~     performed in peripheral blood, the investigators wish to evaluate the ability of this assay~     to predict which patients are at higher risk of relapse from T-cell lymphoma. Additionally,~     as more is known about the ability of dynamic monitoring of cfDNA in B-cell lymphomas to~     predict relapse, the investigators wish to explore the use of this technology in T-cell~     lymphomas.~   "
20574|NCT03297684|"~     To assess the biomarker profile in diabetic macular edema patients in response to~     intravitreal aflibercept injection. Patients with diabetic macular edema who meet study~     requirements will receive monthly intravitreal injections of aflibercept as approved by FDA~     for a period of 6 months. A small quantity of fluid will be removed from the vitreous at each~     injection for laboratory evaluation of biomarkers present before, during and after treatment~     with aflibercept.~   "
20575|NCT03297671|"~     The investigators aim to demonstrate the feasibility of point-of-care identification of~     Rh-negative women in a poor, rural setting in Pakistan. Feasibility will be assessed across 2~     major domains: 1) acceptance by pregnant women to receive the point-of-care test; and, 2)~     ability of health workers to administer the point of care test and interpret results. The~     investigators will also measure whether RhIg prophylaxis can be successfully delivered and is~     accepted by pregnant women in this setting. The socio-demographic correlates of the~     acceptance of point-of-care testing and where applicable, the acceptance of RhIg prophylaxis~     will also be assessed. In addition, the investigators will also explore the baseline~     knowledge of Rh disease among pregnant women and lady health visitors in this study~     population and will investigate socio-demographic correlates of baseline knowledge and the~     uptake of knowledge among pregnant women. Finally, the prevalence of Rh negativity will be~     calculated and stillbirth and neonatal mortality will be tracked among all participants. All~     stillbirths and neonatal deaths in this population will be characterized with respect to~     cause and Rh-negativity.~   "
20576|NCT03297658|"~     This is a single site, randomized, blinded, sham controlled, parallel group study to identify~     whether electro-acupuncture (EA) is a beneficial anesthesia adjunct in children undergoing~     procedures on their congenital heart defects (CHD).~   "
20577|NCT03297645|"~     The goal of this study is to evaluate a sustainable, community-engaged program to reduce~     asthma disparities among 5 to 11-year-old children in Richmond, Virginia. Richmond, an urban~     center, has been named the Asthma Capital, or most challenging place to live in the U.S.~     with asthma, by the Asthma and Allergy Foundation three times in the last 5 years. To date,~     however, the city has no comprehensive, community-engaged asthma care program for those~     children at highest risk for poor asthma outcomes. To address this disparity, the study team~     engaged with community partners and completed a mixed-methods needs assessment to enhance~     understanding of the barriers and supports to asthma care for children and their families~     living in Richmond. Several key priority areas emerged: peer support, advocacy, treating the~     home as a system, increased school nurse education, and coordination with schools and~     providers. Working together, the community-engaged team translated needs assessment findings~     to RVA Breathes, a program coordinating asthma care across 4 sectors: family, home,~     community, and medical care.~   "
20578|NCT03297632|"~     Falls and fractures are serious and costly events for elderly individuals: they cause~     functional impairments, increase mortality and contribute to huge healthcare costs for the~     society. The number of falls, and following consequences, are expected to increase in society~     as the proportion of the elderly population will increase, therefore it is crucial to be able~     to detect and prevent falls and fractures in the population. The investigators have~     previously published results that objective measurements of postural balance can predict fall~     risk in 70-year-olds in Umeå and subsequently investigated whether balance can be improved~     through 4-week balance exercise program. However, preliminary results suggest that the~     frequency and duration of exercise should be longer than 3 times a week for 4 weeks to~     produce effects. Furthermore, there is also evidence indicating a link between muscle~     weakness and fall risk in elderly subjects, while research findings show that it is possible~     for older individuals to influence muscle strength and muscle mass with resistance exercise.~     Functional strength training can also positively influence the balance. In this context, the~     investigators aim to investigate whether a 10-week resistance exercise program may positively~     affect balance, muscle strength, muscle mass and physical function, with the aim of~     preventing future falls and fractures in the population.~   "
20579|NCT03297619|"~     The goal of this study is to compare the efficacy and mechanisms of change of two self-help~     books for social anxiety in college students in a randomized controlled trial. One book is~     based on traditional cognitive behavioral therapy and one is based on acceptance and~     commitment therapy.~      This study will test the following hypotheses:~      Hypothesis 1: The CBT and ACT book conditions will both experience decreased social anxiety~     and distress. Life satisfaction and values progress will increase in both conditions.~      Hypothesis 2: The CBT condition will result in greater use of reappraisal, the ACT condition~     will not.~      Hypothesis 3: The ACT condition will result in greater use of defusion and decreased~     psychological inflexibility; the CBT condition will not.~      Hypothesis 4: Changes in experiential avoidance and defusion will predict changes in social~     anxiety and values progress in the ACT condition.~      Hypothesis 5: Changes in reappraisal will predict changes in social anxiety in the CBT~     condition. Change in values progress will be predicted by change in social anxiety in the CBT~     condition.~      Hypothesis 6: The association between social anxiety/negative affect and values progress will~     decrease or disappear in the ACT condition (i.e., decoupling), and remain the same in the CBT~     condition.~   "
20580|NCT03297606|"~     Cancer drugs which target the effects of abnormal gene changes are called 'targeted~     therapies'. This study, called PM.1 or CAPTUR, will include some targeted therapies that are~     currently available. The purpose of this study is to find out what are the effects on a~     patient and their cancer when they are given a targeted therapy drug that is specific to an~     abnormal gene change in their cancer.~   "
20581|NCT03297593|"~     Immunotherapy with checkpoint inhibitors that target PD-1 and CTLA-4 have shown activity in~     mRCC. However, the optimal schedule of the combination therapy has yet to be defined.~      The objective of the trial is to determine the efficacy of combination immunotherapy of~     nivolumab and ipilimumab in patients with metastatic renal cell carcinoma.~   "
20582|NCT03297580|"~     Systemic sclerosis (SSc) has heterogeneous symptoms and significant medical morbidity.~     Recently, itch was described as a symptom of SSc (prevalence of 42,6%). To the investigators~     knowledge, no study yet has examined the clinical features of itch neither had used a~     specific itch-related quality of life (QoL) scales in patients with SSc. The objectives were~     to evaluate the prevalence of pruritus, its characteristics and its impact on the QoL in~     those patients.~      In this descriptive study, patients followed for SSc in the departments of dermatology,~     rheumatology, internal medicine and pulmonology at the University Hospital of Brest were~     included. Participants received a questionnaire including questions about the clinical~     features of pruritus and 2 scores (5-D itch scale, ItchyQol).~   "
20583|NCT03297567|"~     Introduction: The level of physical activity decreases progressively with age. Elderly~     subjects who are physically active have lower rates of morbidity and mortality when compared~     to those inactive. Hospitalization leads to long periods of bed rest and physical inactivity,~     with consequent muscle atrophy, generalized weakness, and decreased independence and~     functionality. Therefore, preventing inactivity, loss of muscle strength and the worsening of~     functional performance during hospitalization may be a way to avoid loss of independence. And~     while movement has been increasingly promoted as an important part of the recovery of~     hospitalized patients, many of them still spend much of the time bedridden while in hospital.~     Objectives: To evaluate the impact of a guiding program on the importance of remaining active~     during hospitalization in relation to the level of physical activity, functionality and~     muscular strength of elderly patients and to identify the main barriers that impede them to~     perform physical activities in the hospital environment. Methods: Randomized and controlled~     trial which will include elderly patients admitted to the Respiratory Diseases and Medical~     Clinic wards of the Institute of Medical Assistance to State Public Servants, in São Paulo.~     The intervention group will receive verbal guidelines and one booklet on the deleterious~     effects of hospitalization and the importance of staying active during hospitalization. All~     patients will be evaluated through accelerometry to identify the level of physical activity~     during hospitalization. Functionality will be evaluated through the DEMMI scale, muscular~     strength through handgrip and the main barriers to stay active during hospitalization by~     applying a questionnaire. The days of hospitalization and the clinical complications~     presented by the patients during the stay in the hospital will be noted. The difference of~     the outcomes of the level of physical activity and functionality before and after the~     intervention will be compared between the control and the intervention group through a~     t-test. The length of hospital stay will be analyzed by the Kaplan-Meier test and the~     incidence of complications by the chi-square test.~   "
20584|NCT03297554|"~     Up to 30 parent/child dyads will be recruited to participate in an m-Health intervention~     (delivered over smartphone, iPad/Tablet, or desktop/laptop) to promote healthy behaviors and~     healthy weight among children and their parents.~   "
20585|NCT03297541|"~     Up to 30 parent/child dyads will be recruited to participate in an m-Health intervention~     (delivered over smartphone, iPad/Tablet, or desktop/laptop) to promote healthy behaviors and~     healthy weight among children and their parents.~   "
20586|NCT03297528|"~     Patients with acute leukemia relapsing after allotransplant and who respond to anti-leukaemia~     interventions are at high-risk of a second relapse. Previous studies from investigators~     reported an association between a positive minimal residual disease (MRD)-test after~     transplant and an increased risk of subsequent relapse. Also, patients developing chronic~     graft-versus-host disease (GvHD) after receiving DLI (donor lymphocyte infusion)for leukemia~     relapse after a first allotransplant have a lower likelihood of a second relapse compared~     with similar patients not developing chronic GvHD. And, our previous study also reported~     patients with chronic GvHD after DLI was associated with a greater frequency of a negative~     MRD-test and lower likelihood of subsequent relapse compared with similar persons not~     developing chronic GvHD. Based on these data the investigators designed a randomized control~     study to determine whether giving additional consolidation chemotherapy and DLI might~     decrease likelihood of second relapse in persons without chronic GvHD or with a positive~     MRD-test after initial post-relapse therapy with induction chemotherapy and DLI.~   "
20587|NCT03297515|"~     Prospective, randomised, double-blind study to assess the Therapeutic Potential of Omega-3~     Fatty Acids Supplementation in Dry Macular Degeneration and Stargardt Disease (Macular~     Degeneration Omega-3 Study - MADEOS.~   "
20588|NCT03297502|"~     A phase 3, double-blind, randomized, parallel-group, placebo-controlled, multicenter study to~     evaluate the safety and bioequivalence of Par Pharmaceutical Inc.'s Pimecrolimus Cream, 1%~     and Reference Listed Elidel® (Pimecrolimus Cream, 1%). The study compares both active~     treatments to a placebo control in the treatment of mild to moderate atopic dermatitis.~   "
20589|NCT03297489|"~     This pilot clinical trial studies how well intravital microscopy works in evaluating patients~     with primary peritoneal, fallopian tube, or stage IA-IV ovarian cancer. Intravital~     microscopic evaluation of tumor blood vessels, blood flow, immune cell interactions, and drug~     uptake may be eventually visualized and may lead to valuable prognostic information.~   "
20590|NCT03297476|"~     Based on the investigator's previous data on risk classification for acute leukemia,the~     investigators will design a set of panels to detect the gene expression and genomic variants~     (SNPs, mutation, insertion, deletion and fusion genes, etc), and identify the high-risk~     subtypes of acute leukemia, such as Ph-like acute lymphoblastic leukemia. Furthermore, the~     target therapy (Tyrosine Kinase Inhibitors,et.al) will be used to treat the identified~     patients. In addition, more sensitive minimal residual disease (MRD) detection technology~     will be designed and used to detect the MRD in patients to early predict the disease relapse.~   "
20591|NCT03297463|"~     This is a Phase 1b/2 study designed to evaluate combination of the human T-cell cytokine~     Interleukin-2 (IL-2) and a checkpoint inhibitor Ipilimumab immediately following a course of~     hypofractionated palliative radiation therapy in the management of unresectable,~     relapsed/refractory metastatic melanoma.~   "
20592|NCT03297450|"~     This study evaluates the neuromodulatory effect of combined tDCS and aphasia therapy in~     patients in the acute stage after stroke. Half of the participants will receive aphasia~     therapy and tDCS, the other half will receive aphasia therapy and sham-tDCS.~   "
20593|NCT03297437|"~     The primary objective of this study is to identify predictors of neurofeedback training~     success.~   "
20594|NCT03297424|"~     The purpose of this research study is to evaluate safety, pharmacokinetics, pharmacodynamics~     and preliminary efficacy of the investigational drug PLX2853 in subjects with advanced~     malignancies.~   "
20595|NCT03297411|"~     This study will generate new information on how to optimise brain targets with ECT~     stimulation.~   "
20596|NCT03297398|"~     This study will evaluate the safety and effectiveness of different doses of OPK-88004~     compared to placebo on prostate size and related lower urinary tract symptoms (LUTS) in men~     with benign prostatic hyperplasia (BPH).~   "
24368|NCT03248024|"~     The objective of this study is to analyze the factors influencing the medical and non-medical~     direct costs of patients treated with biotherapy during the last twelve months (infliximab or~     adalimumab), including biosimilars (infliximab biosimilars: Inflectra ™ and Remsima ™) for~     treating Crohn's desease or ulcerative colitis~   "
20597|NCT03297385|"~     Rationale: Understanding the mechanisms of enzalutamide as an androgen receptor inhibitor in~     early prostate cancer could lead to improved patient selection for treatment.~      Objective: To study the effects of enzalutamide on surgical margin status and AR / DNA~     interaction and gene expression.~      Intervention : Men with localized prostate cancer will undergo an additional set of targeted~     tumor biopsies and will be subsequently treated with 3 months of enzalutamide. The~     prostatectomy specimen will be additionally sampled, ex vivo.~   "
20598|NCT03297372|"~     The clinical investigation is a post-market clinical follow up study whereby patients~     undergoing routine cataract surgery will have monolateral implantation of a commercially~     available, CE approved monofocal intraocular lens MicroPure 1.2.3. (PhysIOL, Liège, Belgium).~   "
20599|NCT03297359|"~     Cancer patients that develop blood clots are treated with low molecular weight heparin~     injections (LMWH). One kind of these LMWHs, dalteparin, has its dose determined based on a~     patient's weight using a formula of 200 international units (IU) per kilogram (kg). The~     current dosing of dalteparin approved by Health Canada has a maximum daily dose of 18 000~     IU/day which is weight-adjusted for patients up to 90 kg. Any patient weighing more than 90~     kg would take the same dosage regardless of their weight. The aim of this study is to assess~     the safety of using weight-adjusted dalteparin in cancer-associated venous thromboembolism~     patients that weigh more than 90 kg.~   "
20600|NCT03297346|"~     Breast cancer (BC) radiotherapy leads to coincidental radiation of the heart, resulting in~     increased risk of a variety of heart diseases. Identifying BC patients with the highest risk~     of radiation-induced cardiac complications is crucial for developing strategies for primary~     and secondary prevention. Little has been done on the relationship between dose distribution~     to different anatomical cardiac structures during radiotherapy and early cardiovascular~     changes that may lead to cardiac complications.~      In the framework of the European project MEDIRAD, the EARLY-HEART multicenter prospective~     cohort was launched in August 2017, involving 5 investigating centers from France,~     Netherlands, Germany, Spain and Portugal. With 250 BC patients prospectively followed for 2~     years, the main objective is to identify and validate the most important cardiac imaging~     (echocardiography, computed tomography coronary angiography, cardiac magnetic resonance~     imaging) and circulating biomarkers of radiation-induced cardiovascular changes arising in~     the first 2 years after BC radiotherapy.~   "
20601|NCT03297333|"~     The overall goal of this project is to study the effects of exercise energy expenditure~     matched vigorous dynamic resistance training and aerobic training on cardiac fat, and its~     relationship to cardiac function and geometry using cardiac Magnetic Resonance Imaging.~   "
20602|NCT03297320|"~     All patients admitted to London Health Sciences Centre (LHSC) are asked to indicate their~     preferences for CPR (cardiopulmonary resuscitation) and other life-sustaining treatments that~     necessitate an Intensive Care Unit (ICU) admission.~      Complex, high-risk patients at LHSC require multiple admissions to the hospital towards their~     end-of-life (EOL). Documentation of their resuscitation status should be a part of a broader~     dialogue with patients around their goals of care (GOC) and advance care planning (ACP), but~     rarely is this the case.~      The innovation will involve the use of trained nurse facilitators to have meaningful~     conversations with patients and their families in an effective way that bridges the gap~     between resuscitation status, GOC discussions and ACP across the continuum of care.~   "
20603|NCT03297307|"~     Childhood obesity has been a growing problem with more than 30% of children between 6 and 19~     years old being considered overweight or obese. Obese children are at increased risk of~     developing diabetes, heart disease, metabolic syndrome, and are susceptible to the~     sociological effects of being overweight. Obesity is a multifactorial disease, is often~     familial and multi-generational, and studies have shown that parental obesity can increase~     the risk of a child becoming obese. Currently, one of the most successful treatment options~     for obesity is bariatric surgery. The Nebraska Medicine Bariatric Center offers patients~     counseling in improved dietary management, methods to increase physical activity, and~     psychological support. As part of the programs standard-of-care, each bariatric surgical~     patient receives consultation with a dietician, psychologist, and an exercise physiologist.~     We propose that mothers who are enrolled in the surgical weight loss program bring their~     children to attend the presurgical specialist consultation. Subjects enrolled in the study~     will have their height, weight, and physical activity assessed at preoperative and~     postoperative study visits. Study subjects will also complete questionnaires of their~     self-reported physical activity and eating habits at these study visits. The goal of this~     pilot study is to examine whether this behavioral intervention will have an impact on the~     overall health and weight of children whose mothers have received bariatric surgery.~   "
20604|NCT03297294|"~     The purpose of this study is to evaluate safety and efficacy of EMA401 compared to placebo in~     patients with painful diabetic neuropathy (PDN).~   "
20605|NCT03297281|"~     Benign prostatic hyperplasia (BPH) is a very common pathology of the aging man with an~     incidence that rises from 40% in men aged 50 to 60 years to 90% in men over 80 years. Studies~     such as the MTOPS (the Medical Therapy of Prostatic Symptoms) study show that more than half~     of the patients recruited had an aggravation of their disease over time either by an increase~     in symptoms or by the appearance of complications such as acute retention of urine.~      For benign symptomatic prostate hypertrophy, apart from any complication, first-line~     treatment is now a medical treatment. For patients who respond poorly to medical treatment or~     who have complications related to benign prostatic hypertrophy, the treatment becomes~     surgical. The reference treatment is endoscopic prostate resection (TURP). It is mainly to~     improve the safety of hemostasis in patients older and older and at significant surgical risk~     that new minimally invasive surgical techniques have emerged. Thus, lasers have been~     developed and are currently used as an alternative to the TURP. Used in clinical practice~     since 2000, prostatic photosensitive vaporization (PVP) relies on the absorption of a 532nm~     (green) wavelength laser beam by the oxyhemoglobin contained in richly vascularized prostate~     tissue.~      Given the aging of the population, more and more patients are being treated with oral~     anticoagulants (Anti Vitamin K (AVK) or direct oral anticoagulants (DOACs)). Today there are~     about 1.4 million people on oral anticoagulants, 40% of whom are over 80 years of age. The~     peri-operative management of the AVK is currently based on the recommendations published by~     the FHA (French Health Authority) in 2008. Concerning the perioperative management of DOACs,~     the perioperative haemostasis interest group (GIHP) made proposals updated in September 2015.~      Numerous studies published in the literature have concluded the feasibility of prostate~     removal surgery by PVP with greenlight laser without relay (or interruption) of AVK or DOACs~     because of the properties of hemostasis. But the levels of evidence for these studies remain~     low.~      No study has focused on rigorously assessing the perioperative hemorrhagic risk associated~     with OAC therapy in patients eligible for PVP, and this is the originality of this study.~      This study is a multicenter prospective randomized study whose objective is to show that the~     PVP performed in patients with OAC is not associated with an increase in perioperative~     hemorrhagic risk.~   "
35193|NCT03105934|"~     To assess the correlation between pulmonary IV-OCT and pulmonary IV-US measurements and~     standard PAH clinical measures of disease progression and the relative sensitivity of the~     techniques to change.~   "
20606|NCT03297268|"~     This 3-phase research plan to employ Behavioral and Environmental Sensing and Intervention~     (BESI) will overcome the fundamental scientific barriers to realizing prediction of agitation~     episodes and detection early stages of dementia related agitation. The goal of which is~     empowering caregivers to intervene early and ultimately reduce agitation, thus reducing~     caregiver burden and extending aging-in-place and improving the associated quality-of-life~     and cost benefits.~   "
20607|NCT03297255|"~     This longitudinal observational cohort study was designed to investigate factors that~     influencing the occurrence and long-term survival of patients with primary liver cancer.~     Basic informations and detailed diagnosis informations (AJCC/TNM stage, MELD score,~     Child-Pugh score, and BCLC stage) were collected by professional doctors. Clinical outcomes~     (death, recurrence, and metastasis) will be followed up every two years after therapy.~   "
20608|NCT03297242|"~     Retrospectivly follow-up the outpatients for H pylori eradication failures more than 2 times~     in the digestive department of Changhai hospital from 2015-2017,analyse the eradication rates~     and adverse effects of the therapy with 2w's compound lactobacillus acidophilus followed by~     10d's bismuth, furazolidone, tetracycline contained quadruple scheme.~   "
20609|NCT03297229|"~     Cardiovascular diseases are increasing throughout the developing world and are the cause of~     almost 16.7 million deaths each year, of which 80% occur in low and middle-income countries.~     As more than three fourth of the global burden of cardiometabolic diseases are related to~     risk factors connected with lifestyles or behaviors, such as smoking, unhealthy eating, low~     physical activity, and harmful consumption of alcohol. This burden could be dramatically~     reduced by changing individual behaviors. This study is focused on interventions that are~     aimed to improve the adherence to treatment in cardiovascular disease (hypertension), based~     on a Behavioral Economics approach. Most of public policies targeted to tackle~     Noncommunicable diseases utilize a rational economic model of behavior.~      Behavioral economics, by using insights from cognitive psychology and other social sciences,~     has drawn a lot of attention for its potential to increase healthy behaviors. Interventions~     informed by Behavioral economics principles seek to rearrange the social or physical~     environment in such a way to 'nudge' people towards healthier choices and behaviors. This is~     an individual controlled randomized trial which will be conducted to assess whether the~     implementation of two strategies, blood pressure self-monitoring plus signing a contract of~     commitment, and peer mentoring are effective to reduce blood pressure values over a period~     of 3 months, compared to usual care. This randomized trial will enroll 430 patients from 10~     public primary care clinics in Argentina.~   "
20610|NCT03297216|"~     This is a phase III, double-masked, placebo-controlled, randomized controlled trial taking~     place in Zambia.~   "
20611|NCT03297203|"~     Less than ten years after their intial description, the comprehension of Innate Lymphoid~     Cells (ILCs) biology is rapidly improving. They can be classified into four subgroups (ILCs~     1, 2, 3 and NK cells) on the basis of their cytokine production and transcription factor~     expression.~      They seem to be players in infectious diseases in animals but their role in human~     anti-bacterial defense remains unknown.~      In this prospective work, the investigators will compare ILCs phenotyping in ICU patients~     managed for a septic shock, comparing them to ICU patients without any infectious disease on~     their inclusion. The investigators will also make a large immune mapping in all patients, to~     place ILCs in the global immune depressed state observed in septic patients.~   "
20612|NCT03297190|"~     This cluster randomized controlled study aims to add to the evidence base on mHealth~     interventions by assessing the main effects of delivering nutrition messages on key maternal,~     infant, and young child nutrition (MIYCN) behaviors and outcomes through three innovative~     behavior change strategies. The strategies compared will be: (i) an interpersonal~     communication strategy using the Tanzanian government's Mkoba wa Siku 1000 maternal, infant~     and young child nutrition (MIYCN) curriculum (MwS) through clinic- and community-based~     channels, (ii) the mNutrition SMS text messaging module of the government's Wazazi Nipendeni~     program, and (iii) the combination of both of these strategies (interpersonal and SMS~     messaging). They will be compared with the current standard of care in Tanzania. The goal~     will be to determine which has the greatest impact on key MIYCN and hygiene practices and~     care-seeking behaviors. It will be paired with a costing analysis so that these effects can~     be understood in the context of their costs.~   "
20613|NCT03297177|"~     The study deals with evaluation of safety and efficacy of use of stem/stromal cell isolates~     from autologous microvasculature in neurological, non-neoplastic disease. Autologous cells~     are acquired via microcannula aspiration of subdermal fat deposits, isolated through a~     digestive process, and concentrated via standard centrifugation. The cellular stromal~     vascular fraction (cSVF) created is neutralized and rinsed to eliminate residual enzymatic~     molecules.~      These cells are suspending in sterile Normal Saline Solution (500cc) and re-administered via~     an intravenous parenteral route, passed through a standard sterile 150 u (micron) filter in~     line.~      Multiple tracking and questionnaire followup is intended over a 5 year period, with objective~     and subjective criteria being met. Compilation and analysis of data to be completed after~     that period.~   "
20614|NCT03297164|"~     The main purpose of this study is to build a multi-center, prospective and regionally~     representative acute myocardial infarction(AMI) cohort，and build a study platform for heart~     failure caused by AMI; To explore the 1 year incidence rate of heart failure after AMI given~     the optimized treatment and the treatment model affecting the incidence rate of heart~     failure, and finally to reduce the incidence rate of heart failure by 5%.~   "
20615|NCT03297151|"~     The focus is performance nutrition. Resistance exercise can induce low level muscle damage in~     conjunction with impaired contractile function. Milk-derived proteins contain, or induce,~     bioactive properties that assist muscle recovery and restore/improve muscle function. The aim~     of the research is the recovery of muscle function following resistance exercise.~      In this study, the investigators propose to undertake a comparison of the ingestion of two~     milk-derived protein-based recovery drinks on muscle function after resistance exercise~     compares to an isonitrogenous, non-essential amino acid control.~   "
20727|NCT03295695|"~     This is a single arm, phase 0 study to evaluate the safety and efficacy of PET-CT scans with~     FDG-labeled RBC in patients with breast cancer.~      Cardiac ejection fraction can be calculated and monitored in breast cancer patients during~     chemotherapy using a FDG-RBC PET-CT scan. The purpose of this study is to determine if~     calculated cardiac ejection fraction shows high concordance with results from~     echocardiography.~   "
20616|NCT03297138|"~     The anal complex fistula constitutes a challenge in proctologic surgery because of the of its~     therapeutic care complexity due to the frequency of recurrences and the necessity to protect~     the sphincter function.~      For several years,differents techniques were developed said sphincter sparing techniques to~     handle fistulas at risk on the anal continence.~      Recently there is one of them , named FiLAC using a clip system not yet evaluated.~      The purpose is to assess the success rate of his new surgery technique.~   "
20617|NCT03297125|"~     The purpose of this prospective, nonrandomized controlled phase IV study is to compare~     standard and advanced MRI for their ability to predict response to Optune therapy.~   "
20618|NCT03297112|"~     This pilot clinical trial studies how well contrast-enhanced subharmonic ultrasound imaging~     works in improving the characterization of adnexal masses in patients undergoing surgery.~     Contrast-enhanced subharmonic ultrasound imaging uses high-frequency sound waves to produce~     images of internal organs and when combined with an ultrasound agent such as perflutren lipid~     microspheres, may help improve imaging and management of adnexal masses.~   "
20619|NCT03297099|"~     The indication of laparoscopic surgery is mainly for early regional type hepatolithiasis.~     Open surgery is the traditional treatment method for heptolithiasis. Da Vinci surgical robot~     can overcome limitations of conventional laparoscopic surgery in terms of vision and~     instrumentation flexibility, making the minimally invasive treatment of complex~     hepatolithiasis possible. The study aimed to evaluate the safety, feasibility, and efficacy~     of robot assist laparoscopic surgery for the treatment of complicated hepatolithiasis by~     contrast of open procedures.~   "
20620|NCT03297086|"~     The purpose of this study is to evaluate possible changes of angle kappa after multifocal~     intraocular lens implantation. Presumable influencing factors of postoperative visual axis~     shift (ie. biometric parameters of the eye) are investigated to determine the degree and~     direction of angle kappa alterations.~   "
20621|NCT03297073|"~     The main objective of this study was to evaluate the 5-day kinetics of plasma paracetamol~     levels in postoperative major hepatic surgery (resection greater than or equal to three~     hepatic segments) compared with less extensive liver resection and hepatic re-intervention.~     The clearance of indocyanine green is a marker of hepatic perfusion but also of the proper~     hepatocyte functioning, if hemodynamic conditions are stable.~      Some patients may be operated on up to four or five times in the liver. Moreover, these~     patients probably present an increased risk of postoperative hepatocellular insufficiency due~     to a quantitative and qualitative decrease in their hepatic parenchyma. It is therefore~     interesting to evaluate the use of paracetamol in this situation.~   "
20622|NCT03297060|"~     The goal of this study is to conduct a fully powered Type III hybrid~     effectiveness-implementation trial to test the effectiveness of a comprehensive~     implementation strategy in increasing the implementation of SBIRT for alcohol and other drug~     use in pediatric trauma centers. Our implementation strategy is based on the Science to~     Service Laboratory (SSL), an approach developed by the SAMHSA-funded Addiction Technology~     Transfer Centers (ATTCs) that consists of the same three core elements (i.e., didactic~     training + performance feedback + leadership coaching) used in our Centers for Disease~     Control and Prevention (CDC) study. Based on feedback from the CDC study, two enhancements~     were made to the SSL strategy: 1) integration of the intervention into the electronic medical~     record as a means of improving SBIRT adherence; and 2) development of separate training~     tracks for nurses, social workers and organizational leaders to meet the unique needs of each~     group. In addition, we integrate counseling around the use of prescription pain relievers~     into the SBIRT intervention as an Exploratory Aim, since most pediatric trauma center~     patients are discharged on pain medication and patients with a history of AOD use are at~     elevated risk of opioid misuse. Utilizing a stepped wedge design, a national cohort of 10~     pediatric trauma centers will receive the SSL implementation strategy. Data collection for~     this study relies on multiple sources. At six distinct time points, each of the 10 sites will~     provide data from 30 EMR charts (n = 1800 charts in total). A subset of adolescents will also~     report on fidelity of intervention delivery and linkage to care (i.e., continued AOD~     discussion and/or treatment with a primary care provider) 1 month post hospital discharge. In~     addition, nurses, social workers, and leaders from each pediatric trauma center will report~     on organizational readiness for implementation at three distinct time points. Results of this~     study will demonstrate that a highly scalable implementation strategy, adapted for pediatric~     trauma centers from the results of our mixed-methods implementation trial, will improve the~     fidelity (i.e., the consistency and quality) of SBIRT delivery in pediatric trauma centers.~   "
20623|NCT03297047|"~     The standard treatment for children with closed reduction of displaced distal forearm~     fractures is an immobilization with an upper arm combicast. The hypothesis is that an forearm~     immobilization with combicast in children 4-16 years might be sufficient.~   "
20624|NCT03297034|"~     The SCCSS is designed to investigate which long-term effects childhood cancer and its~     treatment have on survivors, and includes those who were under 21 when they were diagnosed.~     The SCCSS explores childhood cancer survivors' quality of life, the health care received by~     childhood cancer survivors during follow-up care, the effects of medication, somatic and~     psychosocial health issues, how childhood cancer survivors take care of their own health, and~     also collects demographic details like family background, education and profession. To learn~     more about these topics, the investigators send questionnaires to childhood or adolescent~     cancer survivors; to date, they have received almost 2900 completed questionnaires. The~     investigators use the results to inform physicians and patients, and to improve treatment of~     childhood cancer and follow-up.~   "
20625|NCT03297021|"~     The aim is to evaluate the effectiveness of three different regimens of prophylactic~     ondansetron on the incidence and severity of post-operative nausea and vomiting.~   "
20626|NCT03297008|"~     To collect saliva and stool samples using the salimetrics swab and self-stool collection kit,~     process and store samples in a standardized manner. Following this, perform immunological~     assays such as enzyme-linked immunosorbent assay, multiplex bead assay and Immunocap to~     correlate the salivary and fecal levels of biomarkers in healthy donors. As this method is~     non-invasive, we believe that more people will be willing to donate samples.~   "
20661|NCT03296553|"~     Kaposi sarcoma (KS) has an unpredictable course, patients with severe KS and low CD4 counts~     (<100 cells) can develop Immune Reconstitution Syndrome (IRIS) after the initiation of~     combined Antiretroviral Therapy (cART). The objective of this study is to evaluate the~     presence of IRIS and its attributable mortality in patients with HIV and severe KS with the~     use of Ganciclovir or the prodrug Valganciclovir prior to the initiation of cART compared~     with the standard management of immediate cART initiation.~   "
20662|NCT03296540|"~     The studys evaluates the effect of prehospital administration of crushed tablets of Prasugrel~     loading dose (in addition to ASA and standard care) versus uncrushed tablets of Prasugrel~     loading dose on efficacy and safety as well as pharmacodynamics as measured by platelet~     reactivity using VerifyNow.~   "
20663|NCT03296527|"~     To demonstrate non-inferiority of FE 999049 compared with GONAL-F with respect to ongoing~     pregnancy rate in women undergoing controlled ovarian stimulation.~   "
20627|NCT03296995|"~     This is a prospective monocenter, non-randomised, open-lable single-group intervention~     diagnostic trial on the accuracy, reliability and feasibility of the continuous glucose~     monitoring system in critically systemic lupus erythematosus (SLE). Newly developed~     technologies for continuous glucose monitoring in critically SLE patients may improve~     glycemic control and reduce glucose variability. Critically SLE patients will be performed by~     continuous glucose monitoring. The subcutaneous glucose will be continuously monitored in~     critical SLE patients by freestyle libre glucose monitoring system for 14 days. The aim of~     this study is to evaluate accuracy feasibility and acceptance of these methods. To analyze~     accuracy sensor glucose levels will be validated due to venous blood measurements with~     glucose oxidase methods. The influence of several factors like oedema, perspiration, BMI,~     body temperature, pH-value application of vasoconstrictors on accuracy and feasibility of the~     particular system would be evaluated. Furthermore the acceptance of physicians and Nursing~     staff would be evaluated by a questionnaire.~   "
20628|NCT03296982|"~     The study will assess the distribution and variability of whole blood clotting time (WBCT)~     measurement in human blood collected from healthy volunteers that is untreated and spiked~     with predetermined concentrations of edoxaban or enoxaparin.~   "
20629|NCT03296969|"~     We include in our study 200 pregnant women, primigravidas, at term who underwent elective~     lower segment Cesarean section for the first time among the age group of 20 ̶ 35 years.~      The patients are divided randomly into two groups as follows:~        -  Group (A): undergoing rectus muscle re-approximation~        -  Group (B): not undergoing rectus muscle re-approximation~   "
20630|NCT03296956|"~     The purpose of this study is to determine whether a dietary supplement (DS) is effective in~     protecting against sad mood in postpartum as compared to placebo.~   "
20631|NCT03296943|"~     Inhalants, which are neurotoxic central nervous system (CNS) suppressants, are frequently~     abused by young adults. Unlike other CNS depressants, including alcohol and opiates, no~     treatment is currently approved for inhalants dependence. In this report, a novel approach of~     substitution treatment for inhalants addiction was explored in a double-blinded, randomized,~     controlled crossover design to examine the effects of inhalation of essential oil (EO) and~     perfume (PF) on the reduction of cue-induced craving for inhalants in a cohort of thirty-four~     Thai males with inhalants dependence. The craving response was measured by the modified~     version of Penn Alcohol Craving Score for Inhalants (PACS-inhalants)~   "
20632|NCT03296930|"~     The aim of the study is to determine the effect of different direct acting antiviral drugs~     used for treatment of chronic HCV infected patients on normal kidney.~   "
20633|NCT03296917|"~     Phase 2 study, to examine the prophylactic efficacy, safety and tolerability of PrEP-001 in~     asthmatics who have been infected with the human rhinovirus (HRV16) after receiving two doses~     of the study drug/placebo.~   "
20634|NCT03296904|"~     The global goal of the CYBERnetic LowEr-limb coGnitive ortho-prosthesis Plus Plus (CLs++)~     project is to validate the technical and economic viability of the powered robotic~     ortho-prosthesis developed within the 7th Framework Program - Information and Communication~     Technology - CYBERnetic LowEr-limb coGnitive ortho-prosthesis project, as a means to enhance/~     restore the mobility of transfemoral amputees and to enable them to perform locomotion tasks~     such as ground-level walking, climbing/descending stairs, standing up, sitting down and~     turning in scenarios of real life. Restored mobility will allow amputees to perform physical~     activity thus counteracting physical and cognitive decline which occurs with advancing age~     and improving the overall health status and quality of life.~      This project involves players from academia, research institutions, end users, as well as~     robotics and healthcare industry, and has been funded by the European Commission (call~     identifier H2020 - Information and Communication Technology 24-2015, scope c, namely~     Technology Transfer - Robotics use cases, Grant Agreement 731931).~      The CLs++ project is an Innovation Action (IA) and foresees 2 clinical studies aimed at~     assessing the efficacy of the CLs++ modules in different settings.~      In this 1st clinical study, 16 patients with unilateral trans-femoral amputation, 8 @ the Don~     Gnocchi Foundation, Center of Florence, and 8 @ the Free University of Brussels, Dept. of~     Human Physiology, will participate in the assessment of the efficacy of the CLs++~     ortho-prosthesis modules in a clinical setting.~   "
20635|NCT03296891|"~     This project aims to determine the feasibility of conducting a randomized controlled trial~     investigating point of care ultrasound guided resuscitation compared with usual care in the~     management of undifferentiated shock at the Critical Care Trauma Centre (CCTC) in London~     Health Science Centre (LHSC).~   "
20636|NCT03296878|"~     This is a study about how the price of foods affects buying choices at the grocery store. The~     price of foods can have a big impact on what people choose to buy and prices change over~     time. This study is being done to see how changes in food prices affect what mothers choose~     for their families.~   "
20637|NCT03296865|"~     Kinesio taping (KT) has been commonly used in rehabilitation in children with Unilateral~     Cerebral Palsy (UCP). However, there is a lack of studies that verified the effects of KT in~     CP. We aimed to verify the effects of KT in the performance of sit to stand movement (STS) in~     children with spastic UCP (USCP). A blinded, placebo and repeated-measure design was applied.~     The setting was the rehabilitation clinic of the university and care facilities. Eleven~     children, aged from 6 to 12 years old (10.5±-2.8 years), diagnosed with USCP, Gross Motor~     Function Classification System levels I and II were evaluated. KT was applied over rectus~     femoris (RF) muscle of the affected limb. We considered three taping conditions: KT, without~     KT (with tension) and placebo (KT without tension). Mean root mean square (mRMS) of RF;~     initial, final and peak angles, and range of motion of trunk, pelvis, hip, knee and ankles~     joints; and total duration of STS were considered. STS was evaluated from three seat heights,~     neutral (100%), lowered (80%) and elevated (120%). Mixed ANOVA test was applied for angular~     variables of hip, knee and ankle, and mRMS of RF. Repeated ANOVA was applied for angular~     variables of trunk and pelvis, total duration.~   "
20664|NCT03296514|"~     Mindfulness based stress reduction offered to couples where one has metabolic syndrome to see~     if their stress is reduced as measured by bio markers and surveys~   "
21088|NCT03290989|"~     The objective of this study is to have better knowledge about sensations of patients with~     skin carcinomas and to have data about characteristics of pain and pruritus . All patients~     presenting with a suspicions lesion for skin carcinomas will be included and will respond to~     a questionnaire. Demographics data, and histological data about skin carcinomas will be~     collected.~   "
20638|NCT03296852|"~     The purpose of this research study is to test a new medical device, called SONAS. The SONAS~     device is a portable, battery-powered ultrasound device to detect strokes in the prehospital~     environment, such as emergency vehicles (eg. ambulances, helicopters). To demonstrate the~     safety of the device the goal is test it in a small number of healthy volunteers first.~      The SONAS device will be used to detect changes in blood flow to the brain through~     ultrasound, otherwise known as TransCranial Doppler (TCD). To date, the SONAS device has been~     tested extensively in the laboratory, in animals and in human cadavers. The purpose of the~     present study is to test the device for safety and efficacy in a small group of healthy~     volunteers. This study will test the device on 10 healthy volunteers. Each volunteer will~     have a physical examination, neurological examination, and brain MRI both before and after~     the TCD test is performed. All of these study procedures will be performed on 1 visit,~     lasting approximately 5 hours. The brain MRI's will be used to verify the effectiveness of~     the SONAS device on detecting changes in blood flow to the brain.~   "
20639|NCT03296839|"~     Colorectal cancer is a major cause of morbidity and mortality throughout the world and~     accounts for more than 9% of all cancer outcomes. Global mortality from colorectal cancer is~     approximately half the incidence. An estimated 394,000 colorectal cancer deaths occur~     worldwide each year, making colorectal cancer the fourth most common cause of cancer death.~     Overall survival rates after surgical resection of hepatic colorectal metastases were 10-18%~     higher than in patients treated with systemic therapy. Hepatic metastases occur in 45% of~     patients with colorectal cancer. Surgery is the standard of care for resectable diseases,~     with overall survival rates of 5 years (OS) of 28% -58%. Unfortunately, only 10-20% of~     patients have a resectable disease at the time of diagnosis. The current approach to treating~     nonresectable metastatic colorectal cancer (mCRC) promotes the use of combined cytotoxic~     therapy. First-line treatments include cytotoxic combinations. The role of radiotherapy in~     metastatic cancer is historically palliative, conventional radiotherapeutic techniques~     causing radiation-induced liver disease (RLID). With the advent of extracranial stereotactic~     radiotherapy (SBRT), equivalent doses can be safely administered in 3 to 5 fractions, which~     can result in the removal of all affected tissues in the treated area while limiting the~     irradiation of the host organ and the healthy tissues surrounding the tumors. The efficacy~     and safety of SBRT for liver metastases has been confirmed by retrospective studies showing~     local control rates of about 80% or more. Retrospective studies indicate that approximately~     20% of patients remain disease-free 2 to 4 years after SBRT. For patients treated with SBRT,~     some authors found that half of the patients had no metastatic progression or very little~     progression in numbers and metastasis sites. These results confirm the idea of an~     oligometastatic state in which aggressive local therapy could improve progression-free~     survival (PFS). We propose in this study to evaluate the impact of SBRT on progression-free~     survival in patients with mCRC with 1-3 oligometastases of the liver. Two arms will be~     compared: the standard arm treated with chemotherapy; to the experimental arm combining~     chemotherapy and SBRT. The chemotherapy will be left free at the choice of the investigator~     according to the recommendations of national treatments.~   "
20640|NCT03296826|"~     To determine the incidence and risk factors in the development of ovarian, fallopian tube,~     and peritoneal cancers in Japanese women carrying Breast Cancer Susceptibility Gene (BRCA)1/2~     variants.~   "
20641|NCT03296813|"~     TRANSFORM-HF is a large-scale, pragmatic, randomized, unblinded clinical effectiveness study~     comparing torsemide versus furosemide as treatment for heart failure. Approximately 6,000~     patients with heart failure will be enrolled. The primary objective of the TRANSFORM-HF study~     is to compare the treatment strategy of torsemide versus furosemide on clinical outcomes over~     12 months in patients with heart failure who are hospitalized.~   "
20642|NCT03296800|"~     The purpose of this study is to examine the drug-drug interaction in your body when given the~     study drug, bexagliflozin, with three commonly prescribed medications, probenecid, verapamil~     or rifampin. The study will also evaluate how safe the study drug is and how well the study~     drug is tolerated when taken with probenecid, verapamil or rifampin.~   "
20643|NCT03296787|"~     The purpose of this study is to evaluate the effect of varying degrees of renal function on~     the PK of TAK-954 following single-dose IV administration and to investigate the impact of~     hemodialysis on the PK of single IV doses of TAK-954.~   "
20644|NCT03296774|"~     Minority women and women of lower socioeconomic status are at significantly increased risk of~     unintended pregnancies, short inter-pregnancy interval, and short duration of breastfeeding.~     The consequences of poorly timed pregnancies and short duration of breastfeeding for the~     health of mothers, infants and children are well documented.~      To decrease rates of poorly timed pregnancies, increase breastfeeding duration and address~     other postpartum concerns women must be engaged in their postpartum care outside of the~     traditional postpartum visit. In addition to contraceptive counseling and breastfeeding~     support, providers discuss a number of important maternal and child health issues at the~     postpartum visit. These include (1) screening and referral for postpartum mood disorders (2)~     screening for cardiometabolic consequences of pregnancy complications, (3) discussing~     inter-conception care and (4) connecting women with a primary care provider. Thus, as~     recommended by numerous professional societies, the standard postpartum visit at 4 to 6 weeks~     after delivery has considerable value to women's postpartum care.~      Attendance rates for the postpartum visit are markedly lower for women with limited resources~     contributing to racial and economic health disparities. Despite receiving excellent prenatal~     care, only 40% of the economically disadvantaged women who receive prenatal care at the Magee~     outpatient clinic return for their postpartum visit. These parallel national trends, where~     60% of women with Medicaid insurance return for a postpartum checkup compared with over 82%~     of women with private insurance. Medicaid programs serve pregnant women who are particularly~     vulnerable to poor health outcomes and thus this gap is critical. Additionally, minority~     women disproportionally receive Medicaid and thus interventions that focus on Medicaid~     recipients have the potential to address racial as well as economic disparities. These data~     demonstrate that the current care model does not engage all women to make good health care~     decision postpartum and is disproportionately failing our most vulnerable moms and babies.~      Empirically derived concepts from behavioral economics can be leveraged to design~     interventions that support participants to make better health decisions and may be~     particularly useful for postpartum care.~      The feasibility trial will focus on four tenants of behavioral economics—bounded rationality~     (information overload), status quo bias (lack of self-control), hovering (limited attention),~     and framed incentives-- that have been successfully used to tackle stubborn health problems~     such as smoking and obesity. Importantly, unlike tobacco cessation or weight loss, many~     aspects of postpartum care such as compliance with the visit or uptake of LARC, do not~     require on-going action on part of the patient and thus may be particularly amenable to the~     lessons of behavioral economics.~      Specific Aim 1: To conduct a pilot trial evaluating the feasibility and acceptability of a~     future randomized trial to determine the efficacy of Healthy Beyond Pregnancy on adherence~     with the postpartum visit.~      Specific Aim 2: To determine the impact of Healthy Beyond Pregnancy on adherence with the~     postpartum visit.~   "
20645|NCT03296761|"~     To observe the changes of plasma ESM-1 levels in patients with ARDS, and to explore its~     clinical significance.~   "
20646|NCT03296748|"~     The aim of our study is to assess the value of concomitant surgical correction of~     asymptomatic grade II anterior vaginal wall prolapse with the placement of midurethral sling~     for treatment of female patients with stress incontinence~   "
20647|NCT03296735|"~     Central venous catheterization is widely used for various purposes during surgery. For~     central venous catheterization, subclavian vein is selected because of the relatively low~     risk of infection, long-term patency and low patient discomfort. The cross - sectional area~     of the subclavian vein is an important factor to increase success rate. Several studies have~     reported that the Trendelenburg position increases the cross-sectional area of the subclavian~     vein, and the lateral tilt position can change the cross-sectional area of the subclavian~     vein. However, the impact of lateral tilt position to the cross-sectional area of the~     subclavian vein is not clear. The ipsilateral position can increase the cross-sectional area~     of the subclavian vein, and the contralateral position can decrease the cross-sectional area~     by gravity.~      In the first stage of this study, we compare the cross-sectional area of subclavian vein~     using ultrasonography in supine, ipsilateral, and contralateral tilt position.~   "
20648|NCT03296722|"~     Cardiovascular diseases are the main responsible for the global burden of disease for~     non-communicable diseases. Its treatment and prevention is aimed at generating changes in the~     habits of life; however, the percentages of non-adherence are very high. The objective of the~     study was to evaluate the effect of a nutritional intervention in patients with~     cardiovascular risk that incorporates the transtheoretical model and motivational interviews~     on the progression in the stages of change to improve adherence to healthy eating. Methods:~     the investigators included 105 patients who came to the first time at clinical nutrition~     service in external consultation of National Institute of Medical Sciences and Nutrition~     Salvador Zubirán, were randomized to intervention group or control group and the stage of~     change of the transtheoretical model, presence or absence of anxiety and depression,~     anthropometry, blood pressure, physical activity, and food frequency, to determine the~     quality and quantity of food intake, were evaluated. Used X² and t-test for the comparison of~     baseline data between groups and repeated measures ANOVA to assess differences in~     post-intervention.~   "
20722|NCT03295760|"~     The main purpose of this study is the comparison of frequency of vomiting episodes (number of~     episodes per year) observed during the year after the begin of Q10 coenzyme treatment to~     frequency observed during the year before the begin of this treatment in children with cyclic~     vomiting syndrome.~      Secondary purposes are the evaluation of life quality of parents and children, of treatment~     safety and its economic cost compared to other recommended treatments.~   "
20649|NCT03296709|"~     Preformed metal pediatric crowns (CPPm) are currently considered the best method of restoring~     temporary molars affected by severe carious lesions compared to restorations made with~     various restorative materials (amalgams, composites, CVI-based materials). Due to their~     unsightly appearance, denounced by many parents, more aesthetic zirconia (CPPz) preformed~     pediatric crowns have been recently marketed. In the absence of an evaluation of the latter,~     this multi-center fractional oral clinical trial proposes to evaluate clinically and~     radiographically the success rate of pediatric preformed zirconia and metallic crowns.~      One hundred children aged at least 4 years must be recruited in eight departments of~     odontology pediatric hospital-university (Bordeaux, Lille, Nancy, Nantes, Nice, Paris,~     Strasbourg, Toulouse). They will be included if they have two similar temporary molars of the~     same arch (eg first right maxillary temporal molars left) and equally affected, to be~     crowned. The two types of crowns to be used in the same child, CPPm (3M Espe) and CPPz~     (Ezpédo), will be affected by drawing lots. The children will be checked every 6 months for a~     period of 2 years after the placement of the two types of crowns at one week intervals.~     During these four control visits, the success associated with an absence of signs and~     symptoms of irreversible pulpitis or periodontal complications will be sought (main~     endpoint). At the same time, the rate of retention and fracture of CPPs, the gingival~     condition in the vicinity of the analgesics, the antagonist tooth wear and the parental~     satisfaction and that of the children related to each treatment (judgment criteria~     secondary). Each center has a trained and / or calibrated operator and evaluator.~   "
20650|NCT03296696|"~     This is a Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics and~     Pharmacodynamics of AMG 596 in Subjects with Glioblastoma Expressing Mutant Epidermal Growth~     Factor Receptor Variant III (EGFRvIII). This is a first in human (FIH), open-label,~     sequential-dose-escalation study in subjects with EGFRvIII-positive glioblastoma. This study~     will enroll 2 groups of subjects according to disease stage, recurrent disease (Group 1) and~     maintenance treatment after SoC in newly diagnosed disease (Group 2).~   "
20651|NCT03296683|"~     The study objective is to evaluate the added value of MIRA technology as an adjunct to~     mammography in the detection of malignant breast lesions in women with dense breast and/or at~     elevated risk of breast cancer.~   "
20652|NCT03296670|"~     The study intends to evaluate the efficacy of different medicine delivering by targeted~     perfusion catheter in coronary administration on coronary blood flow in STEMI patients with~     CSFP.~   "
20653|NCT03296657|"~     The amount of stannous fluoride in GCF and subgingival plaque samples will be analyzed.~   "
20654|NCT03296644|"~     The main objective of this prospective, controlled clinical study is:~        1. To compare the treatment effects of PowerScope2 and Forsus Fatigue Resistant Device in~          patients with Class II divison1 malocclusion.~        2. To compare the treatment effects of PowerScope2 and Forsus Fatigue Resistant Device with~          the control group.~      The null hypothesis for this study is that Forsus and PowerScope2 are equally effective in~     the treatment of ClassII div1 malocclusion.~   "
20655|NCT03296631|"~     Microbial communities are key components of human environment. Consequently, human gut~     microbiome have been extensively studied providing a better understanding of the relations~     between bacterial populations and host physiology. However, a typical analysis tends to elude~     the complexity of the mixes in term of species, strains, as well as extra-chromosomal DNA~     molecules such as and phages. MetaKids project aims at bringing, at an unprecedented~     resolution, a new view of those populations and the internal relationships during human gut~     establishment, a crucial step with long-term impacts on host health. This project relies on~     the ability of Meta3C, a newly technique developed in the lab, to identify the bacterial host~     genomes of the different phages the investigators will detect thanks to the physical~     collision these molecules experience. Given the role that human gut phages may play in~     shaping the development of host microbiomes, their potential for application is of great~     interest.~   "
20656|NCT03296618|"~     The study is to determine the safety of human neural stem cell transplantation for the~     treatment of paralysis and related symptoms due to chronic motor stroke and to determine the~     maximum tolerated dose.~   "
20657|NCT03296605|"~     This study focus on the cause of obesity and impacts of bariatric surgery on it.~   "
20658|NCT03296592|"~     Patients who have been diagnosed with Cervical Spondylotic Myelopathy will be asked to~     undergo an MRI using diffusion basis spectrum imaging (DBSI) technology. The patients will~     have this MRI preoperatively and at 24 months postop. The investigators believe that with~     this imaging, biomarkers will be able to be seen to assist in prediction of long term~     outcomes in patients with spinal cord compression. These patients will be compared to healthy~     cohorts who will also undergo an MRI using the DBSI technology.~   "
20659|NCT03296579|"~     Acute asthma produces greatly increased work of breathing and increased oxygen requirement~     secondary to bronchial narrowing and airway obstruction by inflammatory secretions. There is~     growing evidence that non-invasive ventilation can reverse these processes more efficiently~     than conventional asthma therapy. Surprisingly, there have not yet been any large scale~     prospective controlled studies to investigate this hypothesis, (either in adults or~     children). Consequently, the aim of this study is to determine if the use of non-invasive~     positive airway pressure, for children admitted to hospital with an acute exacerbation of~     asthma, reduces their work of breathing, need for adjunctive medications, and shortens the~     length of hospital stay, compared to current standard therapy.~   "
20660|NCT03296566|"~     This study is intended to improve the patient experience of communication of colposcopy~     results and follow-up recommendations to patients. Current practice involves results being~     forwarded from the colposcopy clinic to the family or referring physician who then informs~     the patient. We are testing an intervention informed by focus groups in which a trained~     colposcopy nurse (patient liaison) directly contacts patients with their results and~     follow-up recommendations while providing education and support. We will examine whether this~     intervention improves patient satisfaction, reduces anxiety, and improves rates of adherence~     to follow-up and treatment appointments compared to the current practice.~   "
20723|NCT03295747|"~     Aim 1 - Determine the PKD of PMO (menthol) in children with functional abdominal pain (FAP)~     (n=30). Aim 2 - Determine effect of PMO administration on gut microbiome composition and~     contractile activity/gut transit rate.~   "
20665|NCT03296501|"~     The goal of our nonrandomized, open label study is to investigate the safety and efficacy of~     autologous adipose derived mesenchymal regenerative cells (ADRC) transplantation into the~     individuals with diagnosed amyotrophic lateral sclerosis (ALS). All enrolled patients will~     have a documented at least 3-months clinical and electrophisiological observation of ALS~     disease course prior to study enrollment. Each patient will recive 3 injections of ADRC every~     3 months: an intraspinal injection followed by 2 subsequent intrathecal infusions. Safety,~     adverse events and efficacy will be confirmed by clinical, elecrophisiological ( EMG, MUNIX),~     neuroimmaging and spirometry together with functional (ALSFRS-R) and objective motor~     assesment (MRC and dynamometer).~   "
20666|NCT03296488|"~     The primary objective of this study is to determine the safety and efficacy of single doses~     of intramuscular NALDEBAIN on patients scheduled to undergo elective laparotomy. This will be~     performed by administering NALDEBAIN pre-operatively to subjects scheduled to undergo~     elective laparotomy, and assessing the safety and efficacy of the drug compared to PCA with~     fentanyl. The study will demonstrate whether single use of NALDEBAIN is noninferior to PCA~     with fentanyl or not.~   "
20667|NCT03296475|"~     Background: A detailed study of the biomechanical changes before and after abdominal wall~     reconstruction (AWR) has not been performed. Changes in abdominal wall tension and~     intra-abdominal pressure have physiological consequences on respiratory and cardiology~     function. AWR surgeons currently do not know if they are applying too much tension when~     re-aligning the abdominal wall muscles during AWR. Too much tension is likely to cause~     respiratory and cardiac post-operative complications. The investigators propose to study the~     perioperative changes in abdominal biomechanics and cardiorespiratory physiology after AWR.~     In addition, investigators will also analyze the pre-operative patient CT scan to see if~     there any CT predictors of post-operative cardiorespiratory complications and hernia~     recurrence. The researchers hypothesize that there is a threshold value or force at which~     ventral hernias are repaired 'too tight' subjecting the patient to the increased risk of~     recurrence and cardiorespiratory complications.~      Method: An in depth biomechanical and physiological study of 18-22 participants with midline~     ventral hernias will be carried out. Ventral hernias at least 5cm in width and only those in~     which primary fascial closure have been achieved will be included. Any operative technique~     used to achieve primary fascial closure will be included. Biomechanical and physiological~     measurements will be taken at five separate stages during the course of the patients'~     abdominal wall reconstruction. The final lung function tests, taken six weeks post op, will~     be compared to the patients' pre-operative tests. Meticulous attention will be paid to the~     study protocol making sure that in each patient the measurements are all taken at the same~     time and under the same conditions.~      Discussion: This full biomechanical and physiological work up will enable AWR surgeons to~     assess when an AWR patient is subjected to too much biomechanical and physiological stress.~     The abdominal wall tension and strain will be measured to see if this predicts post~     complications and hernia recurrence.~   "
20668|NCT03296462|"~     This RCT is a feasibility study to evaluate the Lois Hole Hospital for Women's Urogynecology~     Clinic's ability to recruit and randomize SUI patients to the proposed RCT, and to test the~     study procedures and follow-up schedule for participants.~      The study interventions used in the feasibility study will be training of (1) Hip Extension~     Rotation (HER) exercises alone, (2) HER exercises in combination with Pelvic Floor Muscle~     (PFM) exercises, or (3) PFM exercises alone (control/usual care) in the treatment of SUI.~   "
20669|NCT03296449|"~     This study compares two ventilatory techniques (continuous positive airway pressure vs high~     frequency jet ventilation) during one-lung ventilation (OLV) in video-assisted thoracic~     surgery (VATS). All patients were ventilated with both ventilatory techniques and parameters~     of gas exchange were determined through arterial blood gas test.~   "
20670|NCT03296436|"~     Patients presenting to Johns Hopkins with a diabetic ulcer classified by the UT Grade 2 or 3~     who meet all of the inclusion and none exclusion criteria and give their informed consent,~     will receive an application of NEOX CORD 1K in addition to standard of care procedures. Those~     patients will be seen in follow-up at weekly visits until the wound closes and epithelize,~     achieving complete closure. Subjects that do not achieve complete ulcer closure prior to or~     at the end of the 16 treatment weeks will exit the study.~   "
20671|NCT03296423|"~     One small recent trial in elderly volunteers showed that BCG vaccination can protect against~     infectious complications, while several studies have demonstrated an increased capacity of~     innate immune responses to react against pathogens. This process, also called trained~     immunity, generates the hypothesis that BCG vaccination can prevent or delay new infections~     in the elderly patients and is studied in the ACTIVATE trial~   "
20672|NCT03296410|"~     Enterovirus 71 (EV71), a major pathogen causing hand-foot-and-mouth disease (HFMD) worldwide,~     is a member of the Human Enterovirus species A, family Picornaviridae. Its infection~     occasionally leads to severe diseases and death, with central nervous system (CNS) damage.~      Recently, except of inactivated vaccine, several EV71 vaccine candidates have been evaluated~     in animals but no final results of clinical trials, such as attenuated vaccine, subunit~     vaccine. A formalin-inactivated EV71 vaccine (Human Diploid cell, KMB-17 Cell) has been~     finished phase I, II and III clinical trials and licensed by SFDA in China at Dec. 3, 2015.~     Based on the results of clinical trials, the protective efficacy of inactivated EV71 vaccine~     is 97% against HFMD caused by EV71. The phase IV clinical trial has been carried out from~     July 2016. The purpose of phase IVd is to evaluated the immunogenicity and safety of the~     inactive EV71 vaccine within two measles attenuated live vaccine and live attenuated Japanese~     encephalitis vaccine at the same time point in large scale population of Chinese children (8~     months old) in Guangdong Province, China.~   "
20673|NCT03296397|"~     External genital warts (EGW) are a frequent disease (typical yearly incidence of 100 to 200~     new cases per 100.000 person-years, typical prevalence of 1 to 4% of the sexually active~     population), with a heavy toll on patients' quality of life: low self-esteem and severe~     impairment of sexual well-being are common consequences. Treatments are painful and take time~     to achieve cure because of low complete remission (20 to 60%) and high recurrence rates (10~     to 40%, 30% on average). Finding new means to reduce these recurrence rates thus seems~     justified. Infection with Human Papillomavirus (HPV) is responsible for EGW,other warts and~     some epithelial cancers. Out of two currently available HPV vaccines (Cervarix and~     Gardasil®), only Gardasil® is  quadrivalent  i.e. contains virus like particles imparting~     protection versus 4 genotypes of HPV, 2 of them responsible of most cancers and pre cancers~     of the cervix (HPV 16 and 18), and 2 for 90% of EGW (HPV 6 and 11). A close to 100 % efficacy~     of the quadrivalent HPV vaccine (QHV) on prevention of EGW in naive patients has been shown,~     leading to their near disappearance in the vaccinated population of countries with a good~     vaccine coverage. Beside this preventive efficacy, literature data also show that HPV~     vaccines have an up-to-100% protective effect versus recurrence of destroyed precancerous~     lesions of the cervix in non-naive patients with an up-to-40 month's follow-up. Also, there~     is anecdotal evidence that they could help treat severe wart conditions. QHV is also safe and~     well tolerated when used in a preventive manner.~      Investigator hypothesis is that QHV could have a protective effect on the recurrence of EGW~     in patients who achieve complete remission.~      The primary objective is to evaluate if the HPV vaccine, as compared to placebo, reduces the~     relapse rate of external genital warts over a 12 month-period after their first injection.~      The primary endpoint is the Relapse-free survival. Relapse will have to be clinically~     confirmed.~      The secondary objectives are : 1. To assess the improvement of the quality of life of the~     patients 2. To investigate the clinical tolerance to three doses of HPV vaccine. The~     secondary endpoints are~        1. Disease relief score as evaluated by patients on a specific questionnaire for~          Condylomata Acuminata (CECA) and Dermatology Life Quality Index (DLQI) self-administered~          questionnaires over the treatment and follow-up periods~        2. The clinical tolerance to HPV vaccine will be evaluated by assessment of the percentage~          of patients with local and/or systemic reactions during the study~      This is a National multicenter Phase III comparative, double blind randomized, two-parallel~     groups clinical trial evaluating the efficacy of Gardasil vaccine versus placebo in EGW~     population. Patients (300) recently cured of EGW will be enrolled over a 18 month-period and~     will be randomized in a 1:1 ratio to receive three intra muscular (IM) vaccinations of either~     Gardasil vaccine (150 subjects) or placebo (150 subjects) :~        -  Group 1: Gardasil (at M0) + Gardasil (at M2) + Gardasil (at M6)~        -  Group 2: Placebo (at M0) + Placebo (at M2) + Placebo (at M6) Subjects meeting all the~          inclusion criteria and none of the exclusion criteria will be vaccinated by the~          investigator or designee of the investigational center and will be examined by the~          investigator or designee 30 minutes post immunization to assess for local and systemic~          reactions.~      All subjects will be followed by the investigators or designee during the study by phone~     contacts and visits on site. Diary cards will be used after each vaccination to follow the~     patients.~      Number of visits /participant: 9 Schedule of visits : 1 selection visit (V0) , 3 vaccinations~     scheduled on site at M0, M2 and M6, 3 phone contacts at M1, M3 and M7, 2 clinical follow up~     visits on site at M9 and M12 + 1 unscheduled visit on site in case of EGW relapse during the~     study~   "
20685|NCT03296241|"~     Stress urinary incontinence (SUI) is a common complaint in women after childbirth. The aim of~     this study was to evaluate the efficacy and safety of non-ablative Er:YAG laser therapy in~     the treatment of SUI and improvement of sexual gratification in parous women. 114~     premenopausal parous women with SUI were randomized in two groups of 57 women; a laser~     intervention group and sham control (placebo) group. Both groups were treated according to~     the IncontiLaseTM clinical treatment protocol for SUI with non-ablative thermal-only Er:YAG~     laser, except that there was no energy output when treating the sham group. Patients were~     blinded to the allocation. At baseline and 3 months after treatment patients were clinically~     examined, answered questionnaires for SUI severity sexual function assessment and their~     pelvic floor muscle (PFM) function was assessed with perineometry. The improvement in the~     laser group will be compared to the improvement in the sham group.~   "
20686|NCT03296228|"~     The purpose of this study is to identify the flexibility radiograph(s) that can most~     accurately predict the curve behaviour after surgical correction of AIS. With these findings,~     the investigators hope to give further guidance for the selection of fusion levels and to~     incorporate different dynamic radiographs into the Lenke Classification, leading to a more~     universal application that can consistently lead to good surgical and clinical outcome.~   "
20674|NCT03296384|"~     Schizophrenia is a chronic and severe mental disorder with a lifetime prevalence of about 1~     per cent, the symptoms can be very disabling and causing a heavy medical and socioeconomic.~      There are significant variations from one population to another. Clinical manifestations of~     schizophrenia (symptoms, evolution, severity of disability) are highly variable. This~     variability, both epidemiological and clinical, is due to genetic and environmental factors.~      Environmental factors may be either risk factors or modifying factors (changing clinical~     presentation but do not alter the risk of disease) for schizophrenia.~      Environmental risk factors have been identified (eg: urbanity, cannabis, migration), but the~     investigators don't know neither the components directly responsible, nor the mechanisms by~     which they increase the risk of schizophrenia.~      To date, there is no study has systematically evaluated the role of environmental modifying~     factors in schizophrenia.~      Environmental factors may be individual, unique to each person (eg cannabis, migration.), or~     population-based (eg ethnic density, socio-economic difficulties.) The identification/~     identifying of environmental risk factors or modifiers, both individual and population, may~     have theoretical implications (understanding of etiopathogenic mechanisms) and practical~     (implementation of preventive measures). The potential effectiveness of preventive measures~     is even greater than the risk attributable to certain environmental factors is important.~      Most studies on environmental factors in schizophrenia were conducted in Anglo-Saxon~     countries and northern Europe, but no study of these risk factors has been conducted in~     France.~      There are important differences environment based on study populations, these results are not~     generalizable to other countries, including France.~   "
20675|NCT03296371|"~     This research trial studies genetic mutations in saliva or buccal mucosa samples from~     patients with embryonal or alveolar rhabdomyosarcoma. Identifying gene mutations may help~     doctors learn about the prognosis of patients with embryonal or alveolar rhabdomyosarcoma.~   "
20676|NCT03296358|"~     A randomized, double-blinded, controlled trial of adding a short burst of corticosteroid to~     the conventional treatment of H1 antihistamines~   "
20677|NCT03296345|"~     Acute vaso-occlusive episodes (VOEs) in sickle cell disease (SCD) are primarily managed with~     opioids. Tolerance and hyperalgesia to opioids develops due to N-methyl-D-aspartate~     (NMDA)-receptor mediated activation of the nociceptive system, and as a receptor antagonist,~     ketamine mitigates this. Intravenous (IV) ketamine has demonstrated efficacy in reducing~     post-operative, chronic, and cancer-related pain in pediatrics, as well as in reducing time~     to pain control in the emergency department (ED) in adults. Limited studies suggest efficacy~     in adult opioid-refractory SCD patients. This study is investigating the safety and~     tolerability of adjuvant low-dose IV ketamine bolus for pediatric SCD VOE in the ED, as well~     as its efficacy in improving pain control and reducing hospitalization.~   "
20678|NCT03296332|"~     This final evaluation intends to evaluate SMASH implementation outcomes and intervention~     effects through quantitative and qualitative assessment, and provide evidence for the~     national government to develop salt-reduction and blood-pressure lowering strategies in large~     scales.~   "
20679|NCT03296319|"~     To compare between the impact of echocardiography guided fluid resuscitation and clinically~     guided fluid resuscitation on critically ill patients in hospital outcome.~   "
20680|NCT03296306|"~     The objective is to show non-inferiority of overall survival between four cycles and six~     cycles of first-line cisplatin based chemotherapy to determine the optimal duration of~     chemotherapy in patients with advanced urothelial carcinoma.~   "
20681|NCT03296293|"~     The impact of PEEP on ICP was dependent on the difference between elevated CVP levels and~     baseline ICP levels. ICP would increase once elevated CVP through PEEP adjustment exceeds the~     baseline ICP.~   "
20682|NCT03296280|"~     This VA QUERI Partnered Evaluation Initiative will evaluate the impact of an immersive~     Point-of-care Ultrasound (POCUS) Training Course on provider skill acquisition and retention;~     the frequency of POCUS use by trained providers; and the barriers/facilitators to POCUS in~     the VHA. Data sources include pre- and post-course assessment tools, medical coding data, and~     course evaluations. Providers that participate in the POCUS Training Course will be compared~     to control providers from wait-listed facilities. Additionally, participating facilities vs.~     wait-listed facilities for the POCUS Training Course will be compared. Findings from this~     project will guide ongoing efforts of the investigators' operating partners, VA Specialty~     Care Centers of Innovation (SCCI) and the VA Simulation Learning and Research Network~     (SimLEARN), to develop a national POCUS training program and facilitate implementation of~     POCUS use system-wide in the VA healthcare system.~   "
20683|NCT03296267|"~     In up to half of patients seen by gastroenterologists, routine examinations fail to find an~     underlying organic, systemic, or metabolic disease that readily explains the symptoms. These~     patients are referred to as patients with disorders of gastrointestinal function, of which~     functional dyspepsia (FD) is one of the most common. Despite intensive research to~     investigate various pathophysiological mechanisms of this disease, the pathogenesis remains~     obscure. The investigators recently demonstrated increased duodenal permeability in FD~     patients, as assessed by mounting routine endoscopic duodenal biopsy specimens into Ussing~     chambers to measure transepithelial electrical resistance and passage of a paracellular~     fluorescent probe. Impaired intestinal barrier function can lead to increased uptake of~     luminal substances which can induce an immunological response in the mucosa. Interestingly,~     using transmission electron microscopy (TEM) in duodenal biopsies, the investigators recently~     observed the presence of a yet to be identified microorganism inside the epithelium and the~     lamina propria of a subset of FD patients (unpublished observations), suggesting increased~     translocation of microorganisms.~      The aim of the project is to investigate whether FD patients display increased translocation~     of microorganisms in duodenal biopsies. The investigators will also test the effect of bile~     acid on translocation of microorganisms and therefore include 20 FD patients and 20 age- and~     gender-matched healthy volunteers in this study.~   "
20684|NCT03296254|"~     The aim of this study is to examine the effectiveness of two mindfulness interventions for~     stress, anxiety and burnout in mental health professionals. Participants will receive the~     treatments in reverse order: a brief intervention based on body exercises and another brief~     intervention based on sitting meditation. It is hypothesized that both interventions will~     decrease stress and anxiety levels and professional burnout, with mindfulness body exercises~     being at least as effective as mindfulness meditations.~   "
20687|NCT03296215|"~     Human health comprises many different states, ranging from perfect health to critical~     illness, so medical facilities should be able to provide medical assistance tailored to the~     patient's degree of disease.~      The Intensive Care Unit (ICU) serves as a place for monitoring and care of patients with~     potentially severe physiologic instability requiring technical and/or artificial life~     support. The level of care in an ICU is greater than that available on the floor or~     Intermediate Care Unit.~      Because of the utilization of expensive resources, ICUs should, in general, be reserved for~     those patients with reversible medical conditions who have a reasonable prospect of~     substantial recovery.~      About one third of hospital mortality occurs in critically ill patients in the intensive care~     unit. On the other hand, critically ill patients are responsible for 10 - 20 % of global~     hospital costs.~      It is well accepted that early appropriate referral of patients to an ICU can significantly~     reduce early and possibly late mortality in the critically ill.At the same time improper~     selection of patients for ICU who block ICU beds often limits bed availability in ICUs. This~     in turn adversely affects the dynamics the whole hospital.~      The Respiratory Intensive Care Unit (RICU) is an area that provides closed monitoring and~     intensive treatment for patients with acute or exacerbated respiratory failure caused by a~     disease that is primarily respiratory.~   "
20688|NCT03296202|"~     HIV infection is now a chronic disease in countries where antiretroviral treatments (ART) are~     largely available. Long-term follow-up is required to describe and understand the evolution~     of morbidities and complications as well as new treatments side effects.~      The main objective of the cohort is to describe and study the evolution of HIV infection in~     ART-treated individuals.~   "
20689|NCT03296189|"~     Précis:~      Randomised control trial to evaluate safety and efficacy of intraluminal injection of high~     pH-high concentration of a long-acting local anesthetic and long-acting glucocorticoid in the~     ureter after ureteroscopy.~      Objectives:~      To evaluate a novel method to ameliorate post-ureteroscopy pain in all patients (with and~     without stents)~      Endpoints:~      Primary endpoint: mean visual analog pain scale (VAS) post-operatively starting at 1 hour, 4~     hours, 8 hours, 24 hours and 7 days post-procedure (minimum of 3 VAS scores). VAS pain,~     ureteral stent symptoms and analgesic requirement will be assessed at different points during~     this time period.~      Secondary endpoint: Postoperative Nausea/Vomiting (PONV), safety of intraluminal injection of~     high concentration alkalinized local anaesthetic solution by comparing adverse events between~     placebo and treatment arms. In addition, rehospitalisation rates and postoperative length of~     stay will be compared between the three groups.~      Population:~      150 adult patients undergoing ureteroscopy for ureteric stone disease stratified into~     negative ureteroscopy and those treated for a stone with or without stent insertion~     postoperatively Number of Sites: Tallaght Hospital Study Duration: 8 months~   "
20690|NCT03296176|"~     The purpose of this project is to study Huntington's disease by metabolomic approach.~   "
20691|NCT03296163|"~     This is a multicenter, multinational, double-blind, 1:1 randomized, parallel-group,~     equivalence Phase 3 study to compare the efficacy and safety of MB02 plus chemotherapy~     (carboplatin and paclitaxel) versus Avastin® plus chemotherapy (carboplatin and paclitaxel)~     in subjects with Stage IIIB/IV non-squamous NSCLC~   "
20692|NCT03296150|"~     As the proportion of oral anticancer treatments is continuously increasing, adherence appears~     as a major issue for patients' outcomes. Poor adherence affects particularly geriatric~     patients due among others to polypharmacy or cognitive impairment. Thus, the need for~     educational programs in this population has been regularly emphasized.~      PRESTAGE educational program was built after an external and internal analysis of educational~     needs in elderly patients treated with oral cancer treatments. It implicates a~     multidisciplinary educational team (nurses, physicians, pharmacists, psychologists,~     physiologists, social workers...). Six educational workshops were designed with the following~     endpoints: disease and treatment understanding, treatment management, nutrition and~     psychological as well as physical well being.~      ADOPT-PRESTAGE is a clinical, prospective, interventional, open-label, multicenter,~     randomized, controlled trial designed to evaluate the impact of PRESTAGE program. It is, to~     the investigators' knowledge, the first randomized controlled trial evaluating the~     acceptability and impact (adherence, clinical benefit) of an educational program in an~     elderly cancer population. The primary endpoint of this trial will be to evaluate adherence~     using an indirect objective adherence measure: the Medication Event Monitoring System (MEMS).~     Secondary endpoints include quality of life, evaluation of changes in patients' behaviors and~     economic evaluation.~   "
20693|NCT03296137|"~     This study will perform tumor-infiltrating lymphocyte (TIL)-based adoptive T-cell therapy in~     combination with checkpoint inhibition on cancer patients across all cancer diagnoses.~   "
20694|NCT03296124|"~     Retrospective Review Study for Prognostic Transcriptional Output Related to Androgen Receptor~     Expression in Patients Treated for High Risk Prostate Cancer with Proton Therapy~   "
20695|NCT03296111|"~     Some patients with dry eye may have severe disabling neuropathic pain. They describe~     spontaneous pain, dysesthesia, hyperalgesia or even allodynia. It is classical to note an~     important discordance between the high intensity of the symptoms and the poverty of the~     clinical signs. These pains are often unrecognized and therefore often not sufficiently~     treated. A significant impact on patient's quality of life may occur. The concept of ocular~     neuropathic pain being relatively recent, few studies have focused on the subject at present.~     Our study aims to shed light on these pains in patients consulting for dry eyes at the~     Ophthalmological Foundation A. de Rothschild.~      The objective of our study is to describe precisely the characteristics of neuropathic eye~     pain and the visual, general and psychological repercussions in these patients.~   "
20696|NCT03296098|"~     This is a Phase IIb multicenter, open-label, non-comparative trial of continuous daily oral~     10 mg of ulipristal acetate (UPA) to evaluate its contraceptive efficacy as the primary~     method of contraception.~   "
20720|NCT03295786|"~     This study evaluates the safety and tolerability of CDNF in patients with Parkinson's~     disease, when dosed directly into the brain using an implanted investigational drug delivery~     system (DDS). Safety and accuracy of the DDS is also being evaluated. One-third of the~     patients will receive monthly infusions with placebo and two-third of the patients will~     receive monthly infusions with either mid- or high-doses of CDNF for a period of 6 months.~   "
20721|NCT03295773|"~     This study is to elucidate the morphologic evolution and remodeling of ICAD under stringent~     control of cardiovascular risk factors.~   "
20697|NCT03296085|"~     Edema, commonly called swelling, is a common medical condition, with many causes. Clinicians~     generally find edema by pressing against a patient's skin, usually on the feet or shins, and~     observing how much dimpling there is in the skin. Most clinicians estimate the amount on a~     scale of mild to severe, or perhaps state the amount as 1 to 4. There is little agreement~     between observers, and it is hard to judge different clinicians' use of these scales. The~     first part of this experiment will demonstrate this inconsistency. After clinicians are shown~     a new technique for measuring edema, the second part of the study will show more accurate and~     consistent measurements. This will help clinicians to measure edema better, and to~     communicate their findings to other clinicians more effectively.~   "
20698|NCT03296072|"~     This will be a randomized, controlled, single center, single- blind, 3 period, 3 treatment,~     cross-over, in situ design which consists of placing pre-eroded bovine enamel specimens intra~     orally using a palatal appliance and testing the remineralizing performance of the~     experimental (dentifrice containing 0.254 Percent weight by weight [%, w/w] sodium fluoride~     (1150 parts per million [ppm] fluoride) and 5% KNO3 [potassium nitrate]), comparator~     (dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) and placebo (Fluoride~     free placebo containing 5% KNO3 [0 ppm fluoride] ) dentifrices 2 and 4 hours (hrs) post~     treatment application, based on surface micro hardness measurements. This study will be~     carried out in healthy adults with a maxillary dental arch suitable for the retention of the~     palatal appliance.~   "
20699|NCT03296059|"~     Acute respiratory distress syndrome (ARDS) in neonates has been defined in 2017.~      The death rate is over 50%.There are no special treatments for acute respiratory distress~     syndrome.~   "
20700|NCT03296046|"~     The main purpose of this study is the description of all French cases of PPBL and the~     establishment of minimal criteria for the pathology diagnosis and its follow-up.~      The secondary objective is the immunologic and genetic characterization of lymphoid cells~     causing the disease.~   "
20701|NCT03296033|"~     The main objective of this study is to determine the time interval following the last~     treatment dose of enoxaparin at which the amount of anti-Xa level activity is reliably less~     than 0.2IU/mL in patients presenting for elective surgery.~   "
20702|NCT03296020|"~     The aim of this study is to investigate the effect of honey administration on pain following~     pediatric tonsillectomy or adenotonsilectomy.~      The patients( children 2-18 years old) will divide into two groups by simple randomization~     method( the control group and the case group).~      After surgery the case group: would instructed to use honey twice a day( 5 ml- one tea spoon~     each time)+acetaminophen syrup+ syrup oxycode( as necessary).~      the control group would get as is customary in our ENT department :acetaminophen syrup+ syrup~     oxycode( as necessary).~      The families would ask to follow treatment protocols for 7 days. From the first to the 7th~     day after the operation , the parents would ask to fill a questionnaire every day for~     assessment of pain intensity by visual analouge scale(VAS) , the numbers of painkillers taken~     daily, the number of times the child awaking at night due to pain, the amount of fluids~     intake daily, the time of commencement of regular oral intake.~      patient would follow up 7-14 days after surgery.~   "
20703|NCT03296007|"~     The aim of the present study is to evaluate the psychophysiological effects of a smart phone~     based mindfulness meditation app (MMA) for individuals with clinically significant symptoms~     of major depression and/or anxiety, or symptoms of chronic pain. Specifically, the study aims~     to examine parasympathetic tone using HRV (primary outcome), mind-wandering and present~     awareness, mood symptoms, and breath focus in groups of participants who self-report~     clinically significant symptoms of depression and/or anxiety (DA), chronic pain symptoms~     (CP), as well as control participants who do not meet our criteria for either (Controls (C).~     All study groups will be randomized to a mindfulness meditation app (MMA+) condition or a~     mindfulness meditation condition without the app (MMA-) after a brief stress-induction~     procedure.~   "
20704|NCT03295994|"~     Rotator cuff tears are one of the most common reasons to seek musculoskeletal care in the~     United States and one of the fastest growing ambulatory surgery procedures. However, data on~     comparison of operative versus non-operative treatment is lacking and urgently needed.~   "
20705|NCT03295981|"~     The purpose of the clinical study is to investigate whether the local delivery of~     bisphosphonate as a surgical adjuvant can decrease the chance of a giant cell tumor of bone~     coming back to the same location. The hypothesis is that the local administration of~     bisphosphonate will decrease the rate of the tumor returning compared to traditional~     aggressive surgical removal of the tumor.~   "
20706|NCT03295968|"~     This study investigates the effect of high intensity exercise, with and without the~     inflammation inhibitor, ibuprofen, on plasma levels of IL-6 and other selective biomarkers of~     inflammation and appetite on food intake and subjective ratings of appetite in normal-weight~     boys.~   "
20707|NCT03295955|"~     Transoral endoscopic thyroid surgery is a emerging surgical technique for thyroid surgery.~     This study to investigate the need for postoperative antibiotics in transoral endoscopic~     thyroid surgery.~   "
20708|NCT03295942|"~     The purpose of this study is to test the safety and efficacy of OMP-336B11. OMP-336B11 is an~     engineered human protein that was designed to bind to the GITR receptor on T cells and~     activate the immune system to recognize and eliminate cancer cells.~   "
20709|NCT03295929|"~     The aim of this work is to create a three-dimensional (3D) finite element model (FEM) of the~     human posterior membranous labyrinth, based on in vivo inner ear magnetic resonance imaging~     (MRI). This model has a pedagogical interest, and can serve as a basis for reflection in~     cases of atypical benign paroxysmal positional vertigos. It can also serve for mechanical~     studies of vestibular physiology.~   "
20710|NCT03295916|"~     The purpose of this study is to evaluate feasibility to treat metachronous multi-site breast~     cancer oligometastasis with stereotactic body radiotherapy (SBRT) in patients on systemic~     therapy.~   "
20711|NCT03295903|"~     Cannabidiol (CBD) is a bioactive cannabinoid compound in marijuana (cannabis sativa), but~     unlike Δ9 tetrahydrocannabinol (THC), lacks the psychoactivity effect of THC. Available~     evidence suggests that there are marked therapeutic CBD effects for diverse disease processes~     including inflammation, cancers, psychosis, and epileptic seizures. The purpose of this~     study, in both younger and older healthy humans, is to improve our understanding of how CBD~     might control and regulate blood vessel health as well as cognitive and exercise performance.~   "
20712|NCT03295890|"~     Self paring study, double blind placebo controlled with chronic tinnitus patients attended at~     the Tinnitus Research Group HC- FMUSP, complaining of neck and/or cervical pain and with~     myofascial trigger point in the head, neck and/or shoulder. They were submitted to a complete~     otolaryngologist evaluation which included history, physical examination and myofascial~     trigger point checkup. Patients also performed blood tests, tonal and vocal audiometry, and~     psychoacoustic tinnitus measures. Self paring study, double blind placebo controlled. Each~     patient will be subjected to the dry needling placebo, 4 sessions, 1 per week, with placebo~     stretching, followed by washout period of two weeks, and 4 more dry needling therapeutic~     sessions and active stretching. On the first day of the study will be conducted the following~     evaluation: questionnaires THI and NDI, quantification of cervical pain and tinnitus through~     the Visual analogue scale (VAS), search and confirmation of the presence of PGM and cervical~     pain, psychoacoustic measures and somatic tests. This evaluation will be repeated at the end~     of the four placebo sessions, at the beginning of therapeutic needling sessions and at the~     end of the same.~   "
20713|NCT03295877|"~     This Phase 1, open-label, multicenter study will investigate the safety and tolerability of~     RO7171009 following single and multiple intravitreal (ITV) administrations in patients with~     GA secondary to AMD. The study consists of two stages: Single Dose-Escalation (SAD) and~     Multiple-Dose (MD) stages.~   "
20714|NCT03295864|"~     The aim of this study is to compare the value of multifrequency tympanometry between patients~     with surgical indication of treatment for a Chiari type I malformation and healthy~     volunteers.~   "
20715|NCT03295851|"~     Preoperative anemia is common worldwide, ranging from 25% in knee arthroplasties to 60% in~     colorectal malignancies. In Singapore, about a quarter (27%) of all patients have anaemia~     prior to operation at a main tertiary center. Currently, the rate of preoperative anemia in~     Singapore General Hospital (SGH) is 26.6%.~      This is an alarming public health issue as the negative impact of preoperative anemia on~     post-surgical outcomes has been well documented and include increased rates of perioperative~     blood transfusion, mortality, adverse cardiac and non-cardiac complications including~     pulmonary complications, wound infections, systemic sepsis and venous thromboembolism, as~     well as prolonged length of hospital stay and increased healthcare costs. These data suggest~     that reducing preoperative anemia prior to major surgery is imperative to improve clinical~     outcomes and decrease healthcare costs.~      This study responds to an urgent need to optimize the current standard practice for managing~     preoperative anemia. It is designed as a randomised, open-label, study to investigate the~     efficacy of intravenous iron compared to oral iron in patients with anemia undergoing major~     surgery to reduce surgical complications. To demonstrate the feasibility of conducting such~     trial in a larger scale, a pilot study with the same design will be conducted. The findings~     of this pilot study will also inform the study design and sample size for the larger study.~      If successful, the results will inform clinical practice guidelines, result in better patient~     and clinical outcomes, reduce burden on the health care system, and change health-related~     policy. For example, all forms of intravenous iron therapy are currently not subsidized by~     the Singapore government which is in stark contrast with allogenic blood transfusion, which~     is subsidised and readily available at a substantially reduced rate to patients. Hence, it~     will cost the patients more out of pocket to be treated with intravenous iron than to have~     allogenic blood transfusion. Incorporating a preoperative anemia correction protocol in the~     current surgical pathway is a potential strategy to combat healthcare cost inflation and the~     increasing demand for blood products.~   "
20716|NCT03295838|"~     The effects of a psychological treatment, Mentalization-Based Treatment, was studied using a~     research protocol with patients with mood swings and impulsive behavior (borderline~     personality disorder).~   "
20717|NCT03295825|"~     The primary objective of this study is to use heparin-binding protein (HBP) concentration to~     indicate the presence, or outcome, of sepsis over 72 hours after ED admission. The secondary~     objectives of this study are to separately evaluate the performance of HBP to predict outcome~     in patients with suspected infection over 12-24 hours after ED admission.~   "
20718|NCT03295812|"~     Recent years, the European Association for the Study of the Liver-chronic liver failure~     (EASL-CLIF) has defined and graded acute-on-chronic liver failure (ACLF) based on CANONIC~     study which enrolled cirrhotic patients with acute decompensation. However, the~     characteristics and definitions of ACLF in non-cirrhotic patients with acute deterioration of~     liver function and organs injury or failure remain to be clear. As for patients who don't~     fulfil ACLF criteria, there might be a subgroup with high risk of progression (>25%) and a~     moderate 4-week mortality rate (>7%), which can be defined as pre-ACLF, while the others~     are just chronic liver disease with mere liver injury or decompensation. This~     stratification system was primarily verified in a previous retrospective cohort which~     enrolled Hepatitis B patients only. The stratification criteria for chronic alcoholic liver~     disease needs to be further defined in detail. Therefore, investigators plan to prospectively~     recruit 3000 chronic alcoholic hospitalized patients with liver dysfunction from 24~     hepatology departments in China, aiming to propose a stratified diagnostic system for chronic~     alcoholic patients based on organs injury. Meanwhile, risk factors of disease progression and~     short-term mortality will be analyzed, while characteristics and prognosis will be compared~     between patients with and without cirrhosis.~   "
20719|NCT03295799|"~     Warfarin remains the only oral anticoagulant effective in preventing stroke and valve thrombi~     for patients having mechanical heart valves (MHVs). Within Edmonton, Alberta, our~     pharmacist-directed and staffed Anticoagulation Clinic (AC) is referred all MHVs implanted,~     and now has ~450 active patients. The AC mandate is to work with patients to ensure they have~     a thorough understanding of their warfarin therapy and the factors that may impact its~     control. In European countries patients are often taught to manage their own warfarin therapy~     (=Patient Self-Management [PSM]) and achieve good warfarin control and outcomes. Despite~     advocating for a patient-centred approach for healthcare delivery in Alberta, no established~     programs (or funding models) exist to teach and provide ongoing support for PSM in North~     America. The patient population (namely MHVs) served at our AC offers a unique opportunity to~     implement PSM given they are already aware of their therapy and only require some extra~     training and support to assume their own management. While it is anticipated that an increase~     in pharmacist AC resources would be necessary to teach patients to self-manage, the~     establishment of a PSM program has the potential to free up AC resources in the long-term,~     allowing more patients to be managed with reducing waiting times for the AC. With~     infrastructure in place, the AC could serve as a centre of excellence for PSM, accepting~     referrals for this level of care from across the province. Given the patient-centred approach~     to care delivery in Alberta, it remains prudent to assess patient acceptability to the PSM~     approach to anticoagulation care delivery. As such, the primary objective of this randomized~     pilot study is to assess the effect of PSM compared to AC care on quality of life. Our~     results will inform a larger scale future trial.~   "
20728|NCT03295682|"~     In this study patients will be observed, who receive a multi-branch stent graft tailored to~     the patients anatomy for the endovascular treatment of a thoracoabdominal aortic aneurysm~     Crawford type I, II, III, IV or V.~      The objective of this study is to evaluate clinical and technical success as well as safety~     and feasibility of the multi-branch stent graft Systems used in endovascular treatment of~     thoracoabdominal aortic aneurysms that cannot be treated with commercially available devices.~     Primary endpoint of this study is the rate of patients with stable or decreasing aneurysm~     size at 12 months follow-up.~   "
20729|NCT03295669|"~     Close analysis of right ventricular function is still not done by all clinicians, even though~     it is indispensable; notably in cardiovascular ICUs.~      Right ventricular dysfunction is responsible for increased morbidity and marks a turning~     point in the patient's prognosis.~      It is difficult to analyse, and is principally assessed using echocardiography and by~     measuring the peak of the S' wave with pulsed Doppler and by measuring the tricuspid annular~     plane systolic excursion (TAPSE) in the TM mode. New studies have shown the interest of using~     2D strain as a marker of systolic and diastolic function of the right ventricle. Finally, the~     use of 3D ultrasound seems to be more reliable than cardiac MRI for fine analysis of the~     right ventricle, even though it is rarely used in routine practice.~      Study of the right ventricle using ultrasonography alone requires experienced and available~     operators for closely repeated evaluations making it possible to detect right ventricle~     dysfunction quickly.~      US monitoring of left and right heart function is done systematically and repeatedly during~     post-operative care following heart surgery. This US evaluation could be optimized by finding~     a way to monitor the right ventricle continuously.~      From a physiological point of view, we know about the tight relationship between the aspect~     of the central venous pressure curve and more precisely the C-X segment (tricuspid bulging~     into the atrium and start of contraction of the right ventricle) and right ventricular~     function. We wish to analyse this segment, combined with a US evaluation, and to look for a~     possible correlation so as to allow continuous, easy-to-interpret monitoring of right~     ventricular systolic function.~      This will be facilitated by the systematic presence of a central venous catheter in every~     patient undergoing heart surgery, thus allowing central venous pressure to be monitored.~      To this end, we wish to collect different data from patients in the cardiovascular ICU,~     especially the central venous pressure curve, the ventilatory pressure curve and settings of~     the respirator, and to carry out an echography evaluation of each patient.~   "
20730|NCT03295656|"~     This study evaluates the ability of contrast-enhanced ultrasound to improve the diagnosis of~     acute appendicitis in children compared to conventional ultrasound.~   "
20731|NCT03295630|"~     This study will determine whether an Actigraph GT3X accelerometer can identify body position~     and quantify step count in a ward based population recovering from critical illness.~   "
20732|NCT03295617|"~     Introduction: Giant thoracic disc herniation is a rare condition for which surgical treatment~     is indicated when there are signs of spinal cord injury. To date, several surgical techniques~     have been described in the treatment of this condition on small patient series. The main~     objective is to evaluate the long-term results of a series of 53 patients treated with a~     minimally invasive endoscopic procedure. The secondary objective is to explain our~     pre-operative planning and the technical details of our procedure. METHOD: Retrospective~     monocentric study on a cohort of patients treated in our department. The following medical~     data from our database are analyzed: Morbidity of operative gesture (duration of procedure,~     bleeding, postoperative complications), clinical results at the last follow-up visit~     (thoracic Japanese Orthopedic Association (JOA) score, Frankel score, parietal pain , ability~     to walk, wish to carry out the same intervention again if necessary). On the radiological~     level, we evaluated the quality of the resection (total, subtotal, incomplete and~     impossible), the reappearance of a border of cerebrospinal fluid perimedullary and the~     presence of an intramedullary T2 hyperintense signal MRI post- operative. All these data are~     collected and analyzed anonymously. Expected Results: We believe we can demonstrate that~     thoracoscopy is a valid therapeutic option in the treatment of thoracic disc herniation~     responsible for spinal cord compression. This with a low morbidity given the minimally~     invasive nature of the approach.~   "
20733|NCT03295604|"~     Aim: In this ramdomised clinical trial (RCT), the aim was to compare clinical periodontal~     data of subepithelial connective tissue graft (SCTG) group and SCGT+enamel matrix derivatives~     (EMD) group in terms of gained gingiva volume (GGV) and gained gingiva surface area (GGSA) by~     scanners of computer-aided design/computer-aided manufacturing (CAD/CAM) devices.~      Materials and Methods: A total of 35 Miller class I-II gingival recession defects were~     involved in this study (n=17 in SCTG group, n=18 in SCTG+EMD group). In addition to~     periodontal clinical parameters, three dimensional (3D) images were recorded using CAD/CAM~     system before the treatment, at the 1st month and at the 6th months after the treatment. The~     images were superimposed using softwares and GGV, GGSA were calculated.~   "
20734|NCT03295591|"~     Resection of liver metastasis is potentially curative in patients with colorectal cancer~     bearing liver metastasis. However, early recurrence occurs in up to 30% in 3 months after~     liver resection. To optimize patient selection, the investigators propose to evaluate the the~     value of incorporating circulating tumor cells enumeration to clinical factors in a~     prospective study~   "
20735|NCT03295578|"~     This randomized controlled pilot study has as a main aim to investigate the relationship~     between glucose and cognition and wellbeing, as well as food intake in an at-work setting.~     Additionally, the continuous glucose data collected in the study will be used to investigate~     the inter- and intraindividual variability in glucose response to foods/meal in a real-life~     setting.~      Finally, the study aims to determine if self-monitoring and feedback about food intake and~     health stimulate individuals to make healthier choices.~      This study will have two groups, the feedback group and the control group. The study will~     consist of two self-monitoring periods of two weeks. In between these two self-monitoring~     periods, the participants in the feedback group will be given feedback on their measurement~     data. The control group will not get any feedback.~   "
20757|NCT03295292|"~     This is a investigator-initiated pilot clinical trial to ascertain the safety and efficacy of~     application of ex-vivo cultivated limbal stem cells in human eyes for treating Corneal Haze~     after Photo-Therapeutic/Refractive Keratectomy (PTK/ PRK) and Collagen Cross Linking (CXL).~     Instead of using adjunctive medical therapy like application of MMC (Mitomycin), a technique~     of cell delivery with fibrin sealant can be used. These cells are harvested from~     therapeutically accepted and serologically tested cadaveric corneas. The isolated limbal~     epithelial and mesenchymal or stromal cell suspension will then be cultured in CGMP~     laboratories and be tested for sterlity. These cells have also been shown to be effective in~     treating haze in laser refractive surgery in an animal model. Our initial experience of using~     these cells in a previous clinical trial showed that they were effective in preventing~     corneal haze in patients with burns and ulcers.~   "
21174|NCT03289871|"~     This study evaluates the effect of the medical device Excilor® Fungal Nail Infection in the~     treatment of toenail onychomycosis. Half of the participants will receive the tested product~     and the other half will receive a comparator (Amorolfin 5%). Patients will be followed during~     6 months.~   "
20736|NCT03295565|"~     Rationale:~      The aim of this study is to identify the optimal second line treatment option for patients~     with a poor prognosis metastasized Castration Resistant Prostate Cancer (mCRPC) with respect~     to Clinical Benefit Rate (CBR) rate and quality of life.~      Objective:~      The primary endpoint is CBR in mCRPC patients with poor prognostic features and previously~     treated with docetaxel, randomized between cabazitaxel (Arm A) and novel hormonal agents~     (abiraterone OR enzalutamide) as second-line therapy (Arm B).~      Intervention:~      Patients in Arm A will receive cabazitaxel and prednisone and patients in Arm B will receive~     abiraterone and prednisone OR enzalutamide.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness:~      Treatment regimens evaluated in this trial are used in common mCRPC treatment practice and~     are reimbursed. Risk of side effects or death as a result of treatment is not affected by the~     trial design. At baseline, prior to each treatment cycle and at end of treatment, patients~     are requested to visit the out-patient clinic, where a physical exam will be performed in~     combination with vena puncture for blood analysis. Radiological evaluation will be performed~     at base line, after 3 months of treatment and at end of treatment. All above mentioned~     interventions can be considered as standard practice. Patients are requested to fill out QoL~     and pain/analgesic use questionnaires at base line, prior to each cycle and at end of~     treatment.~   "
20737|NCT03295552|"~     To evaluate the effect of novel DNA demethylating agents in the treatment of metastatic TNBC~   "
20738|NCT03295539|"~     International Multi-Centre registry recording comprehensive data on the use of 'Indigo'~     Mechanical thrombectomy system by Penumbra Inc for the removal of acute clot causing acute or~     critical limb ischaemia.~   "
20739|NCT03295526|"~     Test name:~      Study on selective pelvic lymphadenectomy for IB - IIA cervical cancer Researcher: Wu Xiaohua~     Research Center: Fudan University Shanghai Cancer Center The trial is expected to last for 3~     years Test objectives： The primary goal：The overall therapeutic effect of patients with~     selective lymphadenectomy was not inferior to patients with systemic pelvic lymphadenectomy.~      Secondary goal: Selective lymphadenectomy can reduce the incidence and severity of~     postoperative lower limb lymphedema.~      The study was designed for prospective, randomized, controlled clinical trials. The number of~     subjects: 200 cases. Research groupings Selective pelvic lymphadenectomy group and The~     control group was treated with systematic pelvic lymph node dissection group.~      Follow-up time: 3 years Sample size: 200 cases~      End of the trial:~      Primary end-poin:t three-year survival (overall survival, progression-free survival)~     Secondary end point: lower limb lymph node lymphedema~   "
20740|NCT03295513|"~     The aim of this study is to evaluate chipping and the degree of natural enamel loss opposing~     to monolithic zirconia compared to veneered zirconia restoration.~   "
20741|NCT03295500|"~     The research aims to the primary hepatic carcinoma patients whose diameter of the single~     tumor is equal or less than 5cm.By supervising the changes of liver function, Child-Pugh~     score, ICG-R15 value, secondary reaction, incidence rate of RILD during and after the~     radiotherapy, meanwhile combining the outcome of the progression of disease and the condition~     of survival quality, the optimum proposal could be obtained and apply to clinic thus make the~     treatment safe, effective and personalized.~   "
20742|NCT03295487|"~     To compare the subjective and objective outcomes of TVT-O procedure alone versus the same~     procedure followed by the use of premarin vaginal cream for 3 months in postmenopausal female~     with genuine stress incontinence.~   "
20743|NCT03295474|"~     Pulmonary rehabilitation effectively improves outcomes in patients with chronic respiratory~     disease, however there is a lack of pulmonary rehabilitation centers. Telehealth technology~     is one solution to deliver supervised home-based rehabilitation (tele-rehabilitation).~      However, the feasibility and the acceptability of using telehealth technology to deliver~     tele-rehabilitation has not been assessed in a large scale multicenter study.~      Therefore, the aim of this study is to assess the feasibility and the acceptability of~     telemonitoring system during pulmonary rehabilitation in patients with chronic respiratory~     disease.~   "
20744|NCT03295461|"~     E. officinalis fruit possesses both the antimicrobial and anti-inflammatory activities that~     may prove to be useful against several periodontal diseases with the advantage that it is~     devoid of side effects associated with synthetic drugs. After the careful search of~     literature, none of the studies have reported the effect of local drug delivery of E.~     officinalis preparations on chronic periodontitis.The present study is designed with the aim~     of assessing the effectiveness of Emblica officinalis extract formulations as a potential~     adjunctive therapeutic strategy in the management of chronic periodontititis~   "
20745|NCT03295448|"~     The overall aim is to investigate if circulating fatty acids and lipids are influenced by~     alterations in carbohydrate amount and quality.~   "
20746|NCT03295435|"~     Various definitions of poor dentition in older adults has been linked with inadequate intake~     of nutrients and poor diet quality. This study aims to look at the associations between poor~     dentition as defined by the composition of functional tooth units, and dietary intake of~     nutrients in community dwelling older men.~   "
20747|NCT03295422|"~     Investigator initiated, randomized controlled trial of two radiofrequency (RF)ablation~     protocols currently performed in the electrophysiology lab, but have not been studied~     prospectively to identify which, if either technique, is superior for individuals with~     persistent atrial fibrillation (AF). Two-hundred subjects will be consecutively enrolled and~     randomized to either pulmonary vein isolation only or pulmonary vein isolation plus posterior~     left atrial wall isolation~   "
20748|NCT03295409|"~     Evidence suggests that affirming the self can help people to make changes in their health~     behavior. Typically, people affirm a personally-important value, but evidence suggests that~     affirming the values of family (familial self-affirmation) might exert stronger effects.~     The aim of the present study is to examine the effects of familial self-affirmation versus~     standard self-affirmation versus a control group on smoking cessation.~   "
20749|NCT03295396|"~     The primary objective of this phase II trial is to determine the efficacy and safety of~     ONC201, an oral small molecule imipridone DRD2 antagonist, in adult subjects with recurrent~     high-grade glioma. This study will test the research hypothesis that histone H3 K27M mutation~     sensitizes to oral administration of ONC201 in gliomas.~   "
20750|NCT03295383|"~     Mucous membrane pemphigoid (MMP) describes a group of chronic auto-immune bullous diseases~     (AIBD) of the basement membrane zone (BMZ), characterized by predominant or exclusive mucosal~     involvement, including oral, naso-pharyngeal, laryngo-tracheal, genital, oesophageal, anal~     and ocular mucous membranes. Circulating autoantibodies are directed against various antigens~     of the BMZ: BP180, laminin 332 and type 7 collagen. MMP is a rare disease with an incidence~     of 1.8 new cases/million inhabitants/year in France.~      Scar formation which is secondary to initial inflammation, is a characteristic feature of~     MMP, leading to major disability (e.g blindness and oesophageal, anal, vaginal stenosis) and~     life-threatening situations (e.g. laryngeal stenosis leading to respiratory failure).~      Dapsone is the first line treatment of mild/moderate forms of MMP. Dapsone is used both as~     initial treatment, and as maintenance therapy. However, severe forms of MMP can rapidly~     worsen leading to blindness, aphagia due to esophageal stenosis, respiratory failure due to~     tracheal or laryngeal stenosis, and urinary and sexual dysfunctions due to genital~     involvement. These patients are usually treated using immunosuppressive drugs. Indeed,~     corticosteroids (CS) are not recommended in MMP.~      Cyclophosphamide was considered as the most effective immunosuppressant in severe forms of~     MMP, before the use of rituximab, an anti-CD20 monoclonal antibody (MAb).~      Two series from our group have assessed the advantages and disadvantages of IV pulse and oral~     administration of cyclophosphamide in MMP. Oral administration seems more rapidly effective~     with 54% of complete remission (CR) after a median time of 24 weeks (16-52 weeks).~      The results of 41 patients with severe types of MMP (including a French series of 20~     patients) treated with rituximab have been published. Rate of CR after one and two cycles~     were 66% and 90%, respectively. Clinical improvement was rapid, since a decrease in disease~     activity was observed after 4 weeks of treatment in 64% of patients.~      Our results and those of the literature suggest that rituximab might be more effective than~     cyclophosphamide, which has been considered as the gold standard of treatment in severe forms~     of disease, up to now.~   "
20751|NCT03295370|"~     This randomized, crossover sham controlled trial with sham intended to study the effect of~     electrical stimulation on peripheral nerve (spinal accessory nerve) with acupuncture needle~     in healthy subjects aims to access the effect o electrical stimulation of accessory spinal~     nerve in cortical activation, muscular perfusion and autonomic response in healthy subjects.~      Participants will be assessed through measure changes in cortical activation, local muscular~     peripheral perfusion and autonomic responses before and after intervention and~     intervention-sham, and crossed after a period of wash-out.~      The design aims to contribute to assessment of one electroacupuncture's techniques by~     measuring some of the physiological effects caused by peripheral stimulation.~   "
20752|NCT03295357|"~     There are no clear recommendations concerning the management of patients on ECLS~     (Extra-Corporeal Life Support). Many teams keep patients sedated until removal of the ECLS so~     as to avoid accidents, notably decannulation. Moreover, there are few publications on the~     subject, all the more so as the extubation of patients on ECLS (Extra-Corporeal Life Support)~     is a recent practice. Nonetheless, it is becoming more and more frequent in the~     cardiovascular ICU of Dijon University Hospital. We therefore wished to evaluate the benefits~     of this practice by comparing 2 populations: those with extubation while on ECLS~     (Extra-Corporeal Life Support) and those without.~   "
20753|NCT03295344|"~     Diaphragm dysfunction is found in 10 to 90% of patients following heart surgery.~      In current practice diaphragm dysfunction is evaluated by 2D ultrasonography. Tissue Doppler~     is a validated technique to study heart contractility. Its use in the analysis of diaphragm~     function must be evaluated to determine its interest as a diagnostic tool.~      Better understanding of diaphragm dysfunction following heart surgery will lead to earlier~     management of post-operative respiratory complications and the implementation of preventive~     pre-operative measures.~      We intend to look for correlations between the TM (Time-Movement) mode and tissue Doppler in~     the assessment of diaphragm mobility.~   "
20754|NCT03295331|"~     A Non-Interventional Retrospective Study To Assess The Level Of Asthma Control Among Adults~     at 2 Tertiary Care Centres In Malaysia; Institute Of Respiratory Medicine (IPR) And Hospital~     Serdang. The specific objective of the study is to assess, in real-life clinical practice in~     Malaysia, the level of GINA-defined asthma control and the potential risk factors for~     uncontrolled disease in asthma patients~   "
20755|NCT03295318|"~     Out of the 13 identified serogroups of Neisseria meningitidis (Nm) the six serogroups (A, B,~     C, W, Y and X) are responsible for majority of infections. Presently available vaccines~     effectively protect against A, B, C, W and Y serogroups; but no vaccine that is protective~     against serogroup X is available yet.~      Serum Institute of India Private Limited (SIIPL) has developed a conjugate vaccine against~     serogroups A, C, Y, W and X (NmCV-5).~      The first-in-human Phase 1 study was among 60 healthy adults in USA did not show no any~     safety issues.~      This phase 2 study is designed to evaluate safety and immunogenicity of the non-adjuvanted~     and adjuvanted formulations of NmCV-5 in healthy children 12-16 months of age, in comparison~     with the licensed quadrivalent meningococcal conjugate vaccine (Menactra®).~      Both vaccines will be administered in two dose schedule 3 months apart. among vaccine-naïve~     healthy subjects in Mali. Safety will be assessed by collecting solicited reactions till day~     7 post each dose whereas adverse events will be collected throughout the study. Each subject~     will be followed up for 84 days post each vaccine dose.~      The vaccine immunogenicity will measured using a rabbit complement serum bactericidal~     activity assay (rSBA).~   "
20756|NCT03295305|"~     PRETEC-ABC aims to assess the effect of a new form of cognitive remediation, Action-Based~     Cognitive Remediation (ABCR), in patients with bipolar disorder in remission and healthy~     first-degree relatives on cognition, and to assess the neural assays for treatment effects~     with the purpose of identifying a neural biomarker for pro-cognitive effect. PreTEC-ABC~     consists of two parallel sub studies with identical designs. Sub study 1 includes patients~     with bipolar disorder in full or partial remission and sub study 2 includes healthy~     first-degree relatives.~      It is hypothesized (i) that ABCR vs. a control treatment has a beneficial effect on cognition~     in remitted patients with bipolar disorder remission (sub study 1) and in healthy~     first-degree relatives (sub study 2). It is hypothesized (ii) that this treatment-associated~     improvement of cognition translates into better functional capacity at a six months follow-up~     assessment (secondary outcome). Finally, as an exploratory measure, it is hypothesized that~     ABCR will produce an early change in frontal activity and that this activity will correlate~     with ABCR-associated improvements in cognitive function.~   "
20758|NCT03295279|"~     Dr. Rafael E de la Hoz and colleagues have performed standardized and computer-assisted~     readings of all chest CT scans received by WTC workers and volunteers at the Mount Sinai~     Medical Center between 2003 and 2016. The clinical team sought to assess all findings~     suggestive of airway, interstitial, and neoplastic disease in a systematic way, and correlate~     those findings with clinical, functional, and exposure indicators. The study team's research~     will also involve analyses of longitudinal imaging and functional trends, and~     characterization of the WTC related lower airway diseases and their risk factors, with a~     focus on obesity-related imaging markers.~   "
20759|NCT03295266|"~     This is an open-label, single-dose, Phase 1 study to evaluate the pharmacokinetics (PK) of~     intravenous (IV) MK-3866 in participants with moderate and severe hepatic impairment (HI)~     compared to that of matched healthy participants. The primary purpose of this study is to~     understand the effect of HI on the plasma PK of MK-3866 in order to guide dosing~     recommendations for participants with HI. This study will also evaluate the safety and~     tolerability of MK-3866 in participants with moderate and severe HI.~   "
20760|NCT03295253|"~     Urinary incontinence affects more than 200 million people worldwide. In women, childbirth or~     menopausal aging atrophic vagina, lack of estrogen stimulation of muscular turgor of the~     vagina, decrease tone of the urogenital diaphragm, attenuation and weakening of the urethral~     sphincter all result in stress incontinence, urge incontinence and sometimes mixed~     incontinence respectively.~      The purpose of this study is to evaluate reconstructive lipoplasty with micro-fragmented~     autologous adipose tissue (Lipogems®) in female patients with stress urinary incontinence.~     This is a prospective study of 25 subjects that will be evaluated over a period of one year.~      The treatment consist of the injection of micro fragmented adipose tissue, previously~     extracted from the patient in the area of the urethral sphyncter.~      Patients will have follow ups at 6 months with Urodynamic studies to measure the pre-post~     injection differences to-date. Visual analog score questionnaire and report in subjective~     improvement, pad use and stress cough test will be documented at 1, 3, 6, and 12 months~     follow-up.~   "
20761|NCT03295240|"~     The purpose of this study is to test the safety of Venetoclax in combination with FDA~     approved treatments Bendamustine, Rituximab and Ibrutinib (BR-I). This study will examine the~     effects Venetoclax has on participants when it is given in combination with BR-I.~   "
20762|NCT03295227|"~     There are 2 parts in this study.~      The goal of Part 1 of this clinical research study is to confirm the highest tolerable dose~     of pembrolizumab that can be given to patients with unresectable thymoma or thymic cancer.~      The goal of Part 2 of this clinical research study is to learn if pembrolizumab given at the~     dose that was found in Part 1 of the study can help to control thymoma or thymic cancer.~      The safety of the study drug will be studied in both parts.~      This is an investigational study. Pembrolizumab is FDA approved and commercially available~     for treatment of many types of cancers. It is considered investigational to use pembrolizumab~     to treat thymoma or thymic cancer.~      The study doctor can describe how pembrolizumab is designed to work.~      Up to 30 participants will be enrolled in this study. All will take part in MD Anderson.~   "
20763|NCT03295214|"~     The primary objective of this study is to investigate the Visual Analog Score (VAS) for pain~     within the post-operative setting and determine if there is a statistically significant~     difference between the VAS for PO or IV acetaminophen. It is expected that in doing so the~     investigators can produce the maximal amount of pain relief after surgery while making~     conscientious monetary decisions.~   "
20764|NCT03295201|"~     The aim of this study is to investigate the effects of postural exercise program added to~     pulmonary rehabilitation program on quality of life, exercise tolerance and postural~     stability in children with Cystic Fibrosis.~   "
20765|NCT03295188|"~     This is a 12-week, randomized, double-blind, placebo-controlled study to evaluate the effects~     of scallop-derived plasmalogen on brain fatigue, body weight and changes in blood plasmalogen~     in obese subjects aged 20-75 years old.~   "
20766|NCT03295175|"~     Non-conspicuous penis (congenital megaprepuce, occult penis) is a symptomatic malformation~     that includes phimosis and excessively baggy, urine-filled prepuce with alteration of the~     appearance of the penis. A redundant and enlarged foreskin is the main feature of this~     entity.This congenital anomaly is difficult to diagnose and may have association with other~     pathologies such as buried penis.~      Currently, part of the megaprepuce skin is used to correct the defect. A recent study shows~     that patients with this pathology and hypospadias present mostly defects in the muscle~     dartos. The investigators do not know the physiological bases of the megaprepuce, neither the~     clinical and aesthetics implications of this abnormal tissue for the patient, and how this~     affects the postoperative evolution. With the present study the investigators intended to~     answer these questions and to open paths for future research in this area.~   "
20767|NCT03295162|"~     Assess the efficacy of melatonin as an adjuvant in the treatment of free radical disease in~     septic preterms receiving melatonin compared to those on conventional treatment through~     measuring the level of Malondialdehyde as a marker of oxidative stress and by comparing other~     clinical and laboratory parameters of sepsis in both groups.~   "
20768|NCT03295149|"~     The sleep apnea-hypopnea syndrome (SAHS) is a respiratory disorder characterized by frequent~     breathing cessations (apneas) or partial collapses (hypopneas) during sleep. SAHS is linked~     with the most important causes of death in adults from industrialized countries. Metabolic~     deregulation and cardiovascular and cerebrovascular diseases, such as atrial fibrillation,~     stroke, myocardial infarction and sudden cardiac death, could affect people having untreated~     SAHS. The gold standard method for SAHS diagnosis is in-hospital, technician-attended~     nocturnal polysomnography (PSG). Nevertheless, this methodology is labor-intensive,~     time-consuming, and relatively unavailable, especially in low-resource settings. These~     drawbacks have led to large waiting lists, which delay diagnosis and treatment and limits its~     effectiveness as single diagnostic method for SAHS. Blood oxygen saturation (SpO2) and pulse~     rate (PR) from nocturnal pulse oximetry (NPO) provide relevant and essential information to~     detect apneas. In addition, it is significantly less intrusive for patients and it can be~     easily recorded at patients' home. In the same way, automated signal processing and pattern~     recognition techniques have demonstrated to provide accurate tools able to detect and~     effectively use this information. Therefore, the investigators hypothesize that automated~     pattern recognition of at-home NPO recordings could provide reliable and efficient tools able~     to simplify the management of SAHS. The aim of this study is two-fold: 1) to prospectively~     assess the reliability and effectiveness of at-home NPO in the context of adult SAHS; 2) to~     design, optimize and extensively assess the diagnostic performance of automated NPO-based~     screening tools for SAHS. In order to achieve these goals, both PSG and NPO recordings are~     carried out ambulatory and simultaneously at patient's home. A portable polysomnograph~     (Embletta MPR, Natus) is used for standard PSG at home, whereas a portable wrist-worn pulse~     oximeter (WristOX2 3150, Nonin) is used for ambulatory NPO. In addition, conventional in-lab~     PSG and attended pulse oximetry are also performed simultaneously in the hospital facilities.~   "
20801|NCT03294720|"~     The objective of this study is to evaluate the use of wrapping an ACL graft with a collagen~     matrix tissue wrap and injecting autologous bone marrow aspirate concentrate under the~     wrapping and into the graft. Investigators hypothesize that this method of augmenting ACL~     surgery will accelerate and improve the graft maturation and ligamentization process.~     Investigators propose to test this hypothesis with a series of cases of ACL reconstructions~     evaluated with post-operative MRI mapping sequences and validated clinical outcome measures~   "
20802|NCT03294707|"~     This is a single center, prospective, randomized, placebo-controlled study of AG10 in healthy~     adult subjects~   "
20769|NCT03295136|"~     People of working age spend most of their day at work, and usually have less time to~     participate in other activities, the work day in Israel being one of the longest in the OECD.~     Work places, therefore, present the most suitable setting for health interventions, as they~     are an accessible and available framework and have real potential of creating change.~      The current Health Promotion in the Work Place training course aims to train female employees~     to design, implement, and evaluate a health promotion program in their workplace, as well as~     promote personal change in improving healthy habits, and empowering the participants. A~     unique course has been designed, consisting of 20 sessions- 15 consecutive sessions, and 5~     maintenance sessions throughout the year. The course will focus on acquiring health knowledge~     and health promotion skills, as well as leadership skills and empowerment.~   "
20770|NCT03295123|"~     The objective of this study is to evaluate the impact of denial pregnancy on children's~     health ( anthropometric data, psychomotor development , disease) at different age of~     evaluation ( at birth, 9 months, 24 months and between 2 and 6 years post natal age).~      The hypothesis is the denial of pregnancy may have repercussions on children's outcome.~   "
20771|NCT03295110|"~     Alzheimer's disease and related diseases (ADRD) are a major public health issue. In France,~     nearly 900,000 people have ADRD, which represents about 70% of dementia cases, and the~     expected prevalence for 2020 is 1.2 million.~      Patients with ADRD have cognitive, behavioral and functional impairments that lead to~     progressive impairment of quality of life and autonomy. Maintaining them at home depends~     predominantly on their caregivers, mainly family, spouse or child. By definition, the~     caregiver is the person who provides partial or total support to an elderly dependent person~     or a person with a disability in the vicinity of the victim for the activities of daily~     life.~      The investment of caregivers is therefore both human and financial, representing a greater or~     lesser burden. This burden can significantly affect their quality of life. Indeed, studies~     have shown that caregivers suffer from depletion, anxiety, depression and sleep disorders~     resulting in a deterioration of their health, leading them to greater care consumption. They~     would be more prone to cardiovascular diseases and cancer.~      A review of the literature from 2009 examined 66 studies evaluating the contribution of~     various technologies targeting demented patients and their caregivers. Of these, only 10~     dealt with independence at home and the well-being of the patient and his / her caregiver.~     The main limitations of these studies are the small samples (ranging from 1 to 6 patients),~     the degree of cognitive degradation (mainly moderately severe) and the lack of standardized~     assessment.~      Although new technologies promise powerful home-based solutions, studies evaluating their~     efficacy for patients with ADRD and their caregivers remain scarce and fragile at the level~     of evidence due to methodological biases.~   "
20772|NCT03295097|"~     The investigators propose to study the feasibility, acceptability, usability and outcomes of~     a new clinical decision support system for clinicians of opioid therapy in the context of~     specialist palliative care for serious chronic illness. The system provides clinicians with~     patient-specific genetic information on opioid responsiveness and multi-drug interactions.~     This clinical decision support system should improve the clinician's ability to identify the~     optimal pain medication and dosage, and reduce risks associated with multi-drug treatment.~     Investigators will conduct clinician survey's to collection information about the clinical~     decision support system. Investigators will also conduct patient related questionnaires to~     determine any benefits or improvements in quality of life and symptom management from the~     clinical decision support system.~   "
20773|NCT03295084|"~     This study evaluates the safety, tolerability and pharmacokinetics of oral administration of~     irinotecan in adult patients. Oral irinotecan will be administered as monotherapy in a dose~     escalation trial to establish the Maximal Tolerated Dose. Totally 25 patients will be treated~     with irinotecan tablets as mono-therapy. As an extension trial 12 patients will be treated~     with oral irinotecan in combination with oral capecitabine~   "
20774|NCT03295071|"~     The purpose of this study is to understand the evolution of visual functional and structural~     changes and other associated symptoms in patients with LHON. The relation between genetic,~     lifestyle and/or environmental factors and the LHON disease will be described, and a better~     understanding of the natural history of LHON disease and the healthcare associated to with~     the disease will be sought.~      In addition, we would also like to understand the economic burden for patients and their~     families with LHON resulting from direct and indirect costs they may have because of their~     disease.~   "
20775|NCT03295058|"~     Aplastic anemia is a syndrome of bone marrow failure characterized by peripheral pancytopenia~     and marrow hypoplasia.The theoretical basis for marrow failure includes primary defects in or~     damage to the stem cell or the marrow microenvironment~   "
20776|NCT03295045|"~     Infective endocarditis (IE) is a rare (30 cases / million / year in France) and serious (20 %~     of deaths during hospitalization) disease . Its epidemiological profile was considerably~     modified these last years.New predisposing factors appeared, due to increasing number of~     patients wearing valvular prosthetics. The purpose of this study is to realize in 2008 a new~     observational study on populational basis to describe and analyze the evolution of the~     epidemiology of IE in France, compared to previous studies conducted in 1991 and 1999.~   "
20777|NCT03295032|"~     Stroke is one of the main causes of acquired adult disability in the UK. Many psychological~     problems can also occur post-stroke; this has a marked impact on health service usage. As~     such, there is an outstanding need to increase and improve psychological resources within~     stroke services.~      The investigators proposed to adapt and evaluate the effectiveness of an acceptance and~     commitment therapy (ACT) group intervention for adult stroke survivors and their carers. The~     group will endeavour to promote positive adjustment and reduce levels of depression and~     anxiety.~      This study will have two parts.~   "
20778|NCT03295019|"~     During routine clinical practice, it is observed that patients with suspected obstructive~     sleep apnea (OSA) often reported waking up with a dry mouth during the night or in the~     morning. This 9 week, cross-over group, randomized, single center, study will evaluate the~     efficacy of a proprietary formulation in comforting dry mouth in Sleep Apnea patients.~   "
21175|NCT03289858|"~     This is a prospective, randomized study looking at the effect that a long-acting local~     anesthetic has on pain control in patients having surgery for hip fractures. The~     investigators are conducting the study to see if that reduces the amount of pain medicine~     needed after surgery, and if it reduces other medical complications after surgery.~   "
20779|NCT03295006|"~     This retrospective, multinational, single-arm study will be conducted in at least 8 sites. An~     interim analysis will be conducted with data from 100 patients with up to 10 well defined HCC~     tumor(s) and with at least one tumor ≥3 cm. Normal tissue absorbed dose using pre-procedural~     99mTc MAA SPECT or SPECT/CT imaging will be measured to allow the mean absorbed normal tissue~     dose corresponding to a ≤15% probability of CTCAE grade 3 or higher hyperbilirubinemia (in~     the absence of disease progression) to be calculated. Total bilirubin will be recorded and~     graded according to CTCAE version 4.02. All dose-related SAEs at 3 months follow-up will be~     followed until resolution, death or lost-to-follow-up. AEs related to disease progression~     will not be considered related to TheraSphere.~   "
20780|NCT03294993|"~     The investigators designed a study to assess whether there were any blood flow indexes change~     before and after radial artery puncture with doppler ultrasonography~   "
20781|NCT03294980|"~     Brief Summary: The purpose of the OFICE registry is to characterize and describe the CLL~     patients' population from the Finistere area and evaluates the association between different~     patient characteristics, prognosis and treatment patterns.~      Detailed Description: OFICE is a single center, prospective, observational registry of CLL~     patients designed to provide a general description of the CLL patients' population from the~     Finistere area, France. The registry will also provide information on the association of~     cytogenetic and immunophenotypic characteristics with disease progression, as well as~     treatment patterns and healthcare resource utilization. These data will be accessible and~     beneficial for researchers and physicians and will help guide clinical practice and future~     clinical or fundamental studies.~   "
20782|NCT03294967|"~     To investigate the effect of caffeine on ocular circulation by using Optical Coherence~     Tomography and Optical Coherence Tomography Angiography. This study will evaluate blood~     supply to the inner and outer retina after consumption of 200mg caffeine capsule, in~     particular its effect in high myopes.~   "
20783|NCT03294954|"~     Neuroblastoma is a type of cancer that affects nerve cells in the nervous system. The~     patient's neuroblastoma has either come back after treatment or did not respond to the~     standard medicines used to treat it. Because there is no standard treatment for the patient's~     cancer at this time, they are being asked to volunteer in a gene transfer research study~     using special immune cells.~      This research study combines two different ways of fighting cancer: antibodies and Natural~     Killer T cells (NKT). Antibodies are types of proteins that protect the body from infectious~     diseases and possibly cancer. T cells, also called T lymphocytes, are special white blood~     cells that can kill other cells, including cells infected with viruses and tumor cells. Both~     antibodies and T cells have been used to treat patients with cancers. They have shown~     promise, but have not been strong enough to cure most patients. NKT cells are another special~     subgroup of white blood cells that can specifically go into tumor tissue of neuroblastoma.~     Inside the tumor, there are other white blood cells called macrophages which help the cancer~     cells to grow and recover from injury. NKT cells can specifically kill these macrophages and~     slow the tumor growth.~      Investigators have found from previous research that they can put a new gene into T cells~     that will make them recognize cancer cells and kill them. In a previous clinical trial,~     investigators made artificial genes called a chimeric antigen receptors (CAR), from an~     antibody called 14g2a that recognizes GD2, a molecule found on almost all neuroblastoma cells~     (GD2-CAR). Investigators put these genes into the patients' own T cells and gave them back to~     patients that had neuroblastoma.~      We will expand NKT cells and add GD2-specific chimeric antigen receptors to the cells. We~     think these cells might be better able to attack NB since they also work by destroying the~     macrophages that allows the tumor to grow. The chimeric antigen receptor will also contain a~     gene segment to make the NKT cells last longer. This gene segment is called CD28. In~     addition, to further improve the antitumor activity of the GINAKIT cells we added another~     gene expressing a molecule called Interleukin -15 (IL-15). The combination of these 3~     components showed the most antitumor activity by CAR expressing NKT cells and improved these~     cells' survival in animal models.~      GD2-CAR expressing NKTs have not been tested in patients so far. The purpose of this study is~     to find the largest effective and safe dose of GD2-CAR NKT cells (GINAKIT cells), to evaluate~     their effect on the tumor and how long they can be detected in the patient's blood and what~     affect they have on the patient's neuroblastoma.~   "
20784|NCT03294941|"~     The HepQuant SHUNT test, which is provided as a HepQuant SHUNT Liver Diagnostic Kit, is a~     minimally-invasive test of liver function and physiology which has been designated by the FDA~     as an investigational drug/device combination product.~      Enrollment into one of the 3 Gilead Selonsertib clinical trials (GS-US-416-2124,~     GS-US-384-1943/1944) is required for enrollment into the HepQuant study~   "
20785|NCT03294928|"~     Population in study will be selected from students and staff of the University of Pisa. Right~     carotid artery contour wave analysis will be performed during the application of different~     PEEP levels (from 0 cmH2O to 10 cmH2O) with applanation tonometry technique.~   "
20786|NCT03294915|"~     To compare the use supplementation based on green banana flour versus placebo in the insulin~     sensitivity on individuals who have prediabetes.~   "
20787|NCT03294902|"~     The Pedra Technologies' PedraTM device is a non-invasive, diagnostic device intended to~     measure foot perfusion by assessing blood flow. The PedraTM device comprises a compact~     instrument console connected to a sensor that is pasted onto the patient's foot during~     perfusion assessment. Through skin contact, the device is able to monitor tissue perfusion at~     depths of up to 7.5mm. The monitor console contains opto-electronic instrumentation including~     coherent infrared light sources, photo detectors, and display/control electronics. The sensor~     comprises passive fiber-optic conduits, which transfer infrared light from the console to the~     patient, and relays scattered light from the patient back to the console. The intensity of~     light emitted from the sensor is less than 3 mW, well within the safety envelope of Class I~     laser systems and comparable (or lower than) other commercially available devices such as~     laser Doppler systems. The sole point of contact with the patient is a layer of medical grade~     adhesive tape, which is used to paste the flat sensor onto intact skin.~   "
20788|NCT03294889|"~     The main objective of the phase I/II trial is to determine the safety and efficacy of a~     single fraction SBRT at a dose of 19 Gy in patients with localized prostate cancer.~   "
20803|NCT03294694|"~     This clinical trial is studying the drug Ribociclib (LEE011) in combination with an~     immunotherapy drug called PDR001 (a therapy that uses the body's own immune system to control~     cancer) as a possible treatment for metastatic hormone-receptor-positive (HR+), HER2-negative~     breast cancer (in combination with fulvestrant) or metastatic epithelial ovarian cancer.~      The names of the medications involved in this study are:~        -  Ribociclib (LEE011)~        -  PDR001~        -  Fulvestrant~   "
20804|NCT03294681|"~     The aim of this descriptive study is to collect and describe the characteristics of objective~     measures to explore the specificity of algorithms.~   "
20805|NCT03294668|"~     This study evaluates the KONTAKT social skills group training in Australian adolescents on~     the autism spectrum compared to an active control group which is a group cooking class~   "
21176|NCT03289845|"~     Investigation of stability of the BHX implant in adult patients indicated and counselled for~     a bone anchored hearing aid system. Patients are followed according to clinical practice for~     a total of 12 months in the study. Stability of the implant is evaluated by implant stability~     quotient.~   "
20789|NCT03294876|"~     Cortisol is a naturally occurring stress hormone, made by the adrenal glands in response to~     hormones produced by the pituitary and hypothalamus. Man-made forms of cortisol ('steroids',~     for example prednisolone) have been used for the treatment of rheumatoid arthritis since the~     1950s; they are very effective at reducing inflammation.~      A normal response to taking steroid treatment is that the body needs to make less cortisol.~     Following treatment with steroids, the system responsible for making cortisol can be slow to~     wake up. If someone does not make enough cortisol, they are less able to deal with stress and~     are at increased risk of becoming unwell, or suffering a potentially fatal adrenal crisis. It~     is not clear how common failure of recovery of the adrenal axis is, how long it can last for~     or, if any factors might predict which patients are most at risk.~      This study aims to improve our understanding of hypothalamus-pituitary-adrenal (HPA) axis~     recovery in patients with rheumatoid arthritis treated with prednisolone. The investigators~     will also test potential predictive biomarkers of recovery.~      The study will be conducted in hospital and a clinical research facility. Participants will~     undergo two visits for blood tests and will also be asked to supply three samples of saliva~     on six days over the three weeks of the study.~      A better understanding of the physiology of HPA axis recovery should inform the development~     of tools which would allow prediction of patients at risk following withdrawal of steroid~     treatment. Such tools would be useful to improve patient safety.~   "
20790|NCT03294863|"~     The purpose of this study is to determine whether the use of the embrace device after repair~     of linear cutaneous surgery wounds improves scar cosmesis.~   "
20791|NCT03294850|"~     The purpose of this study is to evaluate imaging and other biomarkers of non-alcoholic fatty~     liver disease before and after bariatric surgery.~   "
20792|NCT03294837|"~     treatment of ventilator associated pneumonia in pediatric intensive care unit according to~     the American guidelines~   "
20793|NCT03294824|"~     NK cells are lymphocytes who play a role in the control of viral infections , tumor and fœtal~     tolerance. They belong to innate immune cells but they have a link with adaptative immunity.~     Indeed, after some viral infections such as CMV, Chikungunya, B hepatitis etc, a subset of~     NKG2C+ NK cells expands and can transfer, in murine models, a  memory  that can better~     control CMV infections. CMV reactivation is a major cause of morbidity and mortality after~     allogeneic hematopoietic ste cell transplantation in humans. The aim of this prospective~     study is to evaluate the role of NK cells, in particular NKG2C+ NK cells in the control of~     CMV but also Adenovirus after allo HSCT. Peripheral NK cells from 30 and 10 patients who~     reactivated respectively CMV and AdV are prospectively studied (extensive phenotyping and~     functional studies before and after administration of anti viral drugs) and compared with 30~     allotransplanted patients who didn't reactivate CMV in a pair analysis, and 30 healthy donors~     serologically + for CMV.~   "
20794|NCT03294811|"~     This is an open randomized clinical trial with two study arms. One group, receiving usual~     care for heart failure, will be compared to another group, receiving usual care plus active~     telemonitoring interference.~      When leaving the hospital, the usual care arm receives a document with a predefined~     medication scheme and advice for the general practitioner (like it is currently done in usual~     care).~      The telemonitoring interference in the other study arm consists of a smartphone application~     to register medication intake and to transmit the data of an automatic blood pressure device~     and a balance to a central platform. The goal is to improve medication uptitration~     (angiotensin-converting-enzyme inhibitor (ACE-I) and bètablockers (BB)) in heart failure~     patients and to improve medication compliance.~   "
20795|NCT03294798|"~     The purpose of this study is to evaluate the dosages of recombinant human serum~     albumin/interferon alpha2b fusion protein injection on HBV subjects. The secondary purposes~     is to get the PK/PD data in recombinant human serum albumin/interferon alpha2b fusion protein~     injection on HBV subjects.~   "
20796|NCT03294785|"~     A multi-center randomized controlled trial assessing the comparative effectiveness and~     cost-effectiveness of Chuna manual therapy for chronic neck pain~   "
20797|NCT03294772|"~     It is well known that attending Day Care Centres (DCCs) can lead to an increase in the~     frequency of infections, due to the high incidence at this age and also the ease of~     transmission among children. This high incidence respiratory tract infections (RTIs) and~     acute gastroenteritis can also have a significant impact on the cost of health care systems,~     increasing the number of medical visits, hospitalizations and prescribing medications as~     symptomatic drugs or unnecessary antibiotics in some cases.The aim of the study was to~     determine whether a multifactorial hand-hygiene program (handwashing with soap and water vs~     hand sanitizer vs control group) reduce episodes due to RTIs and gastroenteritis in children~     attending DCCs. In addition, analyze the cost-effectiveness of these interventions.~   "
20798|NCT03294759|"~     Collagen based -membrane derived from amniotic tissue can be used to help reestablish the~     natural synovial lining of the reconstructed ACL, in effect acting as both a barrier from the~     synovial fluid and as a scaffold to contain autologous mesenchymal stem cells and growth~     factors contiguous with the graft, thus aiding and perhaps accelerating the natural~     maturation and ligamentization process of the implanted graft tissue. Acceleration and~     improvement in graft maturation and strength would be a significant advancement in sports~     medicine allowing safer and earlier return to sports and activity~   "
20799|NCT03294746|"~     Drug induced interstitial lung disease (DIILD) is caused by iatrogenic injury to the lung~     parenchyma and can be caused by over four hundred different drugs in humans. Diagnosing DIILD~     is a challenge for clinicians and radiologists as a positive diagnosis depends on exclusion~     of other causes including respiratory infection, occupational, recreational, and~     environmental exposures, specific respiratory disorders, and systemic diseases.~      The aim of this study is to qualify an objective CT scoring system for DIILD assessment. In~     addition, the quantitative information obtained from CT scans with densitometry and texture~     analysis will be explored.~   "
20800|NCT03294733|"~     Investigators hypothesis is that as human age increases, the size of the carpal tunnel~     decreases.~   "
21059|NCT03291366|"~     Central nervous system (CNS) injury leads to morbidity in patients, which has few good~     rehabilitation measures. Mesenchymal stem cells seem to have regenerative and~     tissue-repairing capabilities. The investigators design this study to infuse mesenchymal stem~     cells (MSCs) intrathecally to CNS injury patients, and observe the safety and efficacy by~     recording the change of nervous system scores, trying to prove the effect of MSC in~     rehabilitate CNS injury.~   "
20806|NCT03294655|"~     In this pilot study, a pre-post experimental design will be used, in which 60 community~     dwelling adults aged 50+ will recruited from a larger parent study, and will then be~     randomized to either a no-contact control or intervention condition. Those in the~     intervention condition will receive a psychoeducational intervention in which they will~     receive scientific literature-based information on resilience and strategies to bolster~     resilience, as well as developing an individualized plan on areas to engage in at home over~     the next four weeks. All participants will return for an immediate posttest using an~     abbreviated version of the baseline battery from the parent study.~   "
20807|NCT03294642|"~     This research study evaluates the feasibility and appropriateness of potatoes as an ergogenic~     aid in comparison to the currently promoted sports gels during a cycling challenge and time~     trial. Using a crossover design, trained cyclists will complete three separate cycling~     challenges and subsequent time trials in which they will consume either potatoes,~     commercially available sports gels, or water only.~   "
20808|NCT03294629|"~     This study will investigate Obstructive Sleep Apnea (OSA) and an automatically Adjusting~     Positive Airway Pressure (APAP) device with new technology called SensAwake™. This requires~     experimental confirmation in a randomised controlled trial with crossover design, comparing~     compliance on standard APAP with compliance using APAP modified by the addition of the~     SensAwake™ modification on consecutive nights in participants with moderate−to−severe OSA.~   "
20809|NCT03294616|"~     An innovative method of needleless transcutaneous electroacupuncture (TEA) using a newly~     developed watch-size stimulator is proposed. Weak electrical current will be delivered via~     skin surface electrodes to acupuncture points related to gastrointestinal functions. The~     stimulator can be attached to the skin near the acupuncture points and therefore daily~     activity of the patient does not need to be altered. Two experiments are designed to prove~     the feasibility of the proposed therapy for gastric complications of Scleroderma .~   "
20810|NCT03294603|"~     This is a single-center, open-label study to characterize the biotransformation and excretion~     of [14C]-CC-220 in healthy male subjects. Each subject will participate in screening, a~     treatment phase (including baseline), and a follow-up phone call. Subjects will be screened~     for eligibility. Subjects who have met all inclusion criteria and none of the exclusion~     criteria at screening will return to the study site on Day -1, and will be domiciled at the~     study site from Day -1 to Day 10. On Day 1, subjects will receive a single oral dose of 1 mg~     [14C]-CC-220 under fasted conditions. Blood, urine, and fecal samples will be collected~     throughout the study for pharmacokinetic (PK; inclusive of metabolite profiling /~     characterization), mass balance, and/or clinical laboratory assessments. Safety will be~     monitored throughout the study. Subjects will be discharged from the study site on Day 10~     following completion of the scheduled study procedures and satisfactory safety review.~     Subjects will participate in a follow-up phone call within 5 to 7 days following discharge.~   "
20811|NCT03294590|"~     This is a 3 year clincal study, to test the efficacy of a parent-targeted text message-based~     intervention program on caries incidence and oral health behaviors (child and parent).~     Parents (n= 850) across all pediatric clinic sites (Boston Medical Center and Community~     Health Centers (CHCs); DotHouse CHC and Codman Square CHC) will be randomized to receive~     either text messages (TMs) regarding oral health or TMs regarding child wellness. The study~     will enroll English and Spanish speaking parents and their youngest child who is < 7 years~     old, has at least one tooth showing, and attends the targeted pediatric clinic to receive~     primary care (n= 1700). Parents will complete self-report surveys at baseline, and 2, 4, 12,~     and 24-months after baseline; receive and respond to TM assessments during the 4-month~     intervention; and will also receive TMs during a 'booster' period of one month, which will~     occur 12-months post baseline. Parent's children will be assessed for caries by a clinical~     oral examination performed by licensed Clinical Examiners at baseline, 12-and-24-months~     post-baseline.~   "
20812|NCT03294577|"~     The purpose of this study is to compare the duration of severe neutropenia (DSN) in patients~     treated with:~      Docetaxel, doxorubicin, and cyclophosphamide (TAC) + pegfilgrastim versus Docetaxel,~     doxorubicin, and cyclophosphamide (TAC) + plinabulin~      Severe neutropenia is an absolute neutrophil count (ANC) <0.5 × 109/L.~      Patient treated in this study will either have HER2 negative, early breast cancer (node~     positive or node negative with high risk of recurrence) Or HER2 negative, metastatic breast~     cancer, who have not received chemotherapy for their metastatic disease.~      Docetaxel, doxorubicin, and cyclophosphamide (TAC) will be used as the chemotherapy in this~     study. These agents are among the most active and commonly used chemotherapeutic agents~     employed for treating patients with breast carcinoma. In particular, TAC chemotherapy has~     been used for the adjuvant treatment of HER2 negative early breast cancer patients with node~     positive disease as well as for node negative breast cancer patients who have a high risk of~     recurrence.~      Plinabulin is a novel small molecule that is being developed for the mitigation of~     chemotherapy-induced neutropenia. Administered by IV infusion on the same day of~     (approximately 1 hour after) chemotherapy (TAC), plinabulin will be given in a single dose~     per cycle. Plinabulin is being studied to see if it is a convenient alternative to G-CSF,~     Pegfilgrastim, for the prevention of chemotherapy-induced neutropenia.~   "
20813|NCT03294564|"~     This study is a pilot study to examine the effects of acute inflammation on cognition and~     emotion in healthy participants using a between-subjects, randomized, double-blind design.~   "
20840|NCT03294213|"~     This study is designed as a prospective observational, non-controlled, non-interventional~     study.~      The aim of this study is to obtain a broad user perspective of the aScope™ 4 Broncho,~     focusing on the device functionalities within regular clinical practice and therapeutic use~     of flexible bronchoscopes in the OR and ICU.~      The study will include a minimum of 100 adult patients admitted to the operating room (OR) or~     Intensive Care Unit (ICU) undergoing at least one bronchoscopy procedure. The inclusion will~     stop when 100 fully evaluable patients or a maximum of 150 patients have been enrolled.~      The involved sites will include patients during a five months' period, from September 2017 to~     January 2018.~   "
20841|NCT03294200|"~     The objective of the study is to generate safety and performance data for the 4Tech TriCinch~     Coil System in symptomatic patients suffering from significant functional tricuspid~     regurgitation with annular dilatation.~      The TriCinch Coil System is a percutaneous catheter-based medical device for tricuspid valve~     repair.~   "
20814|NCT03294551|"~     The work done in this trial builds off of the work previously conducted by this same research~     group in clinicaltrials.gov ID: NCT03057379. Due to some changes in study design, protocol,~     and cohort of interest, a new registration was warranted.~      The overarching goal of this study is to evaluate the effectiveness, cost-effectiveness, and~     sustainability of utilizing statewide immunization information systems (IISs) to conduct~     centralized reminder recall (R/R) to improve human papillomavirus (HPV) vaccination rates~     among adolescents 11-14 years of age.~      The latest recommendations from the ACIP, as of February 2017, modified the vaccination~     schedule for the HPV series for eligible adolescents ages 11-14. Adolescents who receive dose~     #1 between the ages of 11 and 14 are now eligible for their second and final dose 6-12 months~     after their initial dose. Despite U.S. guidelines for vaccinating all adolescents starting at~     age 11 with the HPV vaccine, in 2012 only 53% of 13-17 year old females had >1 dose and 35%~     had 3 doses; 21% of teen males had a vaccination. Modeling studies predict marked reduction~     in HPV associated cancers and in disparities in these cancers if high HPV vaccination rates~     can be achieved.~      With this new dosing schedule for adolescents, the research team proposes to conduct a~     randomized control trial (RCT) utilizing the capabilities of the State Immunization~     Information System (IIS), and create a HPV-specific R/R autodialer and text message to be~     delivered to the parents of patients ages 11-14 of randomly selected practices within New~     York State (excluding NYC). Upon conclusion of this trial, researchers will develop a toolkit~     for dissemination so that other state IIS systems may replicate these centralized reminder~     recall procedures.~   "
20815|NCT03294538|"~     The objectives of this study were to evaluate the therapeutic equivalence of the Test~     formulation, Estradiol Vaginal Cream 0.01% (Teva Pharmaceuticals, USA) to the marketed~     product, Estrace® Cream (estradiol vaginal cream, 0.01%) in patients with atrophic vaginitis,~     demonstrate the superiority of the Test and Reference (active) treatments over Placebo~     (vehicle) cream in patients with atrophic vaginitis, and compare the safety of Test,~     Reference and Placebo treatments in patients with atrophic vaginitis.~   "
20816|NCT03294525|"~     The project is a multi-center, prospective cohort study. The study's total targeted~     enrollment is 400 first-episode patients with depression, 400 patients with bipolar~     depression, and 400 healthy controls.~   "
20817|NCT03294512|"~     The purpose of this study is to create a smartphone app that delivers the educational content~     of the current Intermountain MAWDS* program and allows patients to enter and track their~     MAWDS data within the app; and to determine if a broad-scale project can be conducted within~     the limits of currently available technology. Information from this study will be used to~     design a larger study that is powered to assess the association between data obtained via a~     MAWDS app and heart failure outcomes.~      (*MAWDS- Medications, Activity, Weight, Diet, Symptoms)~   "
20818|NCT03294499|"~     The PACIFY Study is a questionnaire for antenatal(third trimester) and postnatal(three months~     post delivery) Human Immunodeficiency Virus (HIV) positive women attending clinics in London~     and Brighton. The current World Health Organisation guidance advises HIV positive women, who~     are adhering to antiretroviral therapy (ART), to exclusively breastfeed for the first 6~     months of the infant's life and continue supplemental breastfeeding for up to 2 years.~      This is conflicts with the current British HIV Association guidelines which advise exclusive~     formula feeding. The reason for this difference is the relative safety of formula feeding in~     the United Kingdom(UK)against the low but persisting risk of HIV infection through~     breast-feeding. The aim of the PACIFY study is to explore attitudes towards breastfeeding~     amongst HIV positive women, who are either pregnant or post-partum. The study will also~     assess the understanding of current infant feeding guidance by these women and assess their~     current or recent infant feeding practice. It will also look at whether HIV positive mothers~     would be willing and able to comply with special monitoring and guidance whilst breastfeeding~     if the guidelines were to change. The study aims to analyse 100 questionnaires completed over~     a 3-6 month period.~   "
20819|NCT03294486|"~     Glioblastoma is the most common and the most aggressive primary brain cancer in adults.~     Indeed, despite very intensive treatments (i.e. maximal safe surgery, radiotherapy and~     several lines of cytotoxic chemotherapies), inducing significant adverse events, the~     prognosis of glioblastoma patients remains dismal with a median overall survival of ~15~     months. Therefore, more efficient and less toxic therapies are urgently needed to improve~     survival and quality of life of glioblastoma patients.~      The oncolytic virus TG6002 has shown efficacy and good safety profile in several preclinical~     models of glioblastoma in vitro (i.e. cell line) and in vivo (i.e. xenografts in Swiss/Nude~     mice). Comprehensive toxicology studies of TG6002/Flucytosine have been completed in rabbits~     and monkeys supporting safety investigations of TG6002/Flucytosine in human patients.~      Taken these data all together, TG6002/Flucytosine appears as a very promising therapeutic~     strategy in glioblastoma patients that merits consideration for early phase clinical trial.~   "
20820|NCT03294473|"~     This study is related to a previous study, Clinicaltrials.gov ID: NCT02924467. There are some~     modifications in relation to the intervention arms as well as the use of a different cohort,~     thereby justifying the second submission to Clinicaltrials.gov. This trial is taking place in~     New York State, through partnership with the New York State Health Department (excluding New~     York City), and Colorado. Each state will have it's own Clinicaltrial.gov submission -- this~     was decided as some of the intervention components are different enough that separate~     registrations were warranted.~      Despite U.S. guidelines for influenza vaccination of all children starting at 6 months, only~     about half of children are vaccinated annually leading to substantial influenza disease in~     children and spread of disease to adults. A major barrier is that families are not reminded~     about the need for their children to receive influenza vaccination. The investigators will~     evaluate the impact of patient reminder/recall (R/R) performed by state immunization~     information systems to improve influenza vaccination rates by using 4 clinical trials (2 per~     state) in two different states. The investigators will assess effectiveness and~     cost-effectiveness of 1) autodialer R/R 2) text messages R/R 3) mailed postcard R/R as~     compared to 4) standard of care control (no R/R).~   "
21060|NCT03291353|"~     This is an open label, single-arm, pilot trial to evaluate the immune effects, safety and~     tolerability of pembrolizumab in subjects newly diagnosed with acute myeloid leukemia (AML)~     who have persistent leukemia after induction chemotherapy. Patients must have an ECOG~     performance status of 0-1. The enrollment target for this study is 10 patients.~   "
20821|NCT03294460|"~     Background:~      People with the brain disease AUD (alcohol use disorder) have a serious problem with~     drinking. Researchers want to study how different people react to alcohol, and how genes~     affect this. They will focus on a nicotine receptor gene that may increase a person s AUD~     risk.~      Objectives:~      To see if people with variations of a nicotine receptor gene take alcohol differently and~     have different brain responses to alcohol cues.~      Eligibility:~      Healthy Caucasian adults ages 21 - 60 who do not smoke~      Design:~      Participants will be screened in another protocol.~      Participants will have three 9-hour visits. They must have no alcohol or non-prescription~     drugs before all visits and no food or drink before 2 visits.~      At every visit, participants will:~        -  Get a light meal~        -  Have breath and urine tests~        -  Get taxi rides there and back~      At visits 1 and 3, participants will:~        -  Have a thin plastic tube inserted in an arm and connected to a pump for alcohol~          infusion.~        -  Have sensors on their chest to monitor heart rate.~        -  Sit in a chair for 2.5 hours and get alcohol by pushing a button. Their breath alcohol~          level will be monitored.~        -  Answer questions about mood and effects of alcohol~        -  Give blood samples~        -  Relax at the clinic while their breath alcohol level drops~      At visit 2, participants will:~        -  Answer questions and do computer tests~        -  Have an alcoholic drink and a snack~        -  Have a magnetic resonance imaging (MRI) scan. They will lie in a machine that takes~          pictures of the brain. They will do computer tasks.~        -  Have another drink and snack~        -  Relax until their alcohol level drops~      Participants will have a follow-up call after each visit.~   "
20822|NCT03294447|"~     Purpose of the study: To identify if an intervention focused on decreasing fear of falling~     (FOF) in a geriatric primary care setting implemented by an occupational therapist (OT) has~     the potential to decrease falls and improve physical, psychological and social factors~     related to FOF.~      The primary research question: Is there an association between fear of falling among~     geriatric populations and fall prevention interventions that are offered by occupational~     therapist in a geriatric primary care setting?~   "
20823|NCT03294434|"~     Brain tumours are the leading cause of cancer deaths in children, men under the age of 45 and~     women under the age of 25. Glioblastoma is the most common and most malignant primary tumour.~     The predominant treatment is surgical removal of the tumour followed by radiotherapy. Sadly~     the majority of patients given this treatment develop recurrent and progressive disease.~      Better understanding of the invasive margin might improve outcomes by facilitating more~     complete surgical resection beyond the traditional contrast enhancing margins. Diffusion~     tensor MRI (DTI) is an imaging technique which may be able to predict the site of tumour~     recurrence. DTI has previously been shown to identify regions, which have been confirmed with~     biopsies, to be areas of invasive tumours and are present before progression is seen with an~     MRI.~      The primary aim of this study is to qualify an imaging biomarker that can be applied at~     initial presentation, that can accurately predict the site of where glioblastomas will~     progress after treatment and allow personalisation of both radiotherapy and surgical targets.~   "
20824|NCT03294421|"~     Chronic otitis media is a prevalent medical condition, leading to important impact in the~     lives of the individuals with this condition, and a great amount of patients may need~     surgical intervention. The main objectives of the surgery in these cases are to restore the~     anatomy of the middle ear, to improve hearing and to remove the infection to avoid further~     complications. Still, chronic otitis media with cholesteatoma presents high rates of~     recurrence and residual symptoms after surgery.~      The standard technique used for treatment of chronic otitis media is microsurgery.~     Nonetheless, with the development of new technologies that use endoscopy, it is now possible~     to use endoscopic surgery to improve the visualization of the cholesteatoma and ear~     structures by combining both techniques.~      This study will evaluate the efficacy of the combined access surgery technique, which is~     microsurgery combined with endoscopy, for closed tympanomastoidectomy in patients with~     cholesteatoma. Furthermore, the study aims to compare the results of the combined access~     technique and the standard technique by randomizing the patients in two groups: one group~     will receive tympanomastoidectomy by standard technique and the other group will receive~     combined technique.~   "
20825|NCT03294408|"~     Predictive factors of osteoarthritis progression are not yet well understood. However, a~     growing role attaches importance to the subchondral bone. The aim of the present project is~     to determine predictive factors of progression of osteoarthritis at the knee by a multimodal~     characterization of subchondral bone by Medical Resonnance Imaging, direct high resolution~     digitization radiographs and bone texture analysis. At the end of the project, an innovative~     imaging device, combining semi-automatic softwares for texture analysis, control detection~     and image registration would be supplied. This will enable on the one hand a more accurate~     and reproducible way to measure the joint space width of the affected compartment and on the~     other hand, an assistance to better detect patients at risk of progression of their knee~     osteoarthritis. Identifying These progressors patients might permit their selection in~     clinical trials at baseline adapted to their severe disease, using for example biologic~     treatments targeting knee osteoarthritis. The main objective of this study is to analyze the~     predictive capacities of bone texture parameters measured on the high-resolution radiography~     of the knee on the structural evolution of the knee osteoarthritis at 3 years.~   "
20826|NCT03294395|"~     This study evaluates the efficacy of three experimental antibiotics in the treatment of~     uncomplicated anogenital gonorrhoea. The participants will be divided in four groups and will~     receive either one of the three experimental antibiotics (ertapenem, fosfomycin and~     gentamicin) or the current standard antibiotic (ceftriaxone). Both the study team and the~     participant are blinded to the administered treatment. This enables the investigators to~     compare the eradication capacity and safety of the experimental antibiotics with the standard~     treatment.~   "
20849|NCT03294096|"~     Decreased bowel function and loss of appetite in patients who underwent pancreaticobiliary~     surgery contribute impaired nutritional status in postoperative period. It can also affect~     perioperative and oncologic outcomes negatively. Therefore it is important to improve~     nutritional status in postoperative period by supply tailor-made optimal diets. The~     investigators have developed customized postoperative diets and products for~     pancreaticobiliary cancer patients. The investigators expect that nutritional supplement for~     pancreaticobiliary patients will increase the food intake rate and contribute a improvement~     of perioperative outcomes and even oncologic outcomes.~   "
20827|NCT03294382|"~     Medial epicanthal fold is a common skin fold in the inner part of the eye in more than 50%~     Asia population, giving the illusion of a shorter palpebral fissure length and a wider~     intercanthal distance. Currently, various epicanthoplasty techniques have been well described~     to correct epicanthus fold. However, hypertrophic scarring after epicanthoplasty remains a~     clinical challenge, which seems inevitable and may leading to unpleasing supratarsal crease,~     recurrence of medial epicanthus fold, even obvious scar formation. Botulinum toxin type A~     (BTX-A) is widely used for facial rejuvenation and many other medical indications. It is a~     potent neurotoxin that indirectly blocks neuromuscular transmission and leads to functional~     denervation of striated muscle for 2 to 6 months after injection. Recently, experimental~     study and clinical trails have revealed that BTX-A can inhibit the growth of fibroblasts~     derived from hypertrophic scars and influenced the expression of transforming growth~     factor-β1. Therefore, we hypothesized that BTX-A can improve hypertrophic scarring after~     epicanthoplasty through release orbicularis oculi muscle tension, inhibit fibroblast growth,~     and reduce collagen production. The main aim of this trail is to evaluate the efficiency of~     BTX-A injection on improving hypertrophic scaring after epicanthoplasty.~   "
20828|NCT03294369|"~     This epidemiological and observational study is aimed to assess cardiovascular risk (CVR) by~     investigating the prevalence of CVR factors (CVRF), target organ damage (TOD) and~     cardiovascular disease (CVD) in general population of the sanitary area of Toledo.~   "
20829|NCT03294356|"~     To determine the rate and amount of nicotine uptake with 10-minute ad libitum use of five~     different marketed electronic cigarettes, or one combustible cigarette (CC). Furthermore, to~     measure overall product liking by subjects to assess potential willingness to seek out the~     Electronic Cigarette (EC) again in the future.~   "
20830|NCT03294343|"~     Based on studies of Inherited Susceptible Genes Among Epithelial Ovarian Cancer~     (NCT03015376, clinicaltrials.gov) and Cohort Study of Universal Screening for Lynch Syndrome~     in Chinese Patients of Endometrial Cancer (NCT03291106, clinicaltrials.gov), we provide~     risk-reducing surgeries of salpingo-oophorectomy with/without hysterectomy for healthy~     carriers with mutation genes of hereditary ovarian cancer, which is defined ovarian cancer~     with relevant pathogenic mutations.~   "
20831|NCT03294330|"~     The objective of this study is to determine if fluorescence lymphangiography can be used~     alone to localize sentinel nodes in patients with melanoma or breast cancer. The hypothesis~     is that sentinel nodes can be identified using only indocyanine green (ICG) and fluorescence~     lymphangiography, without the need for technetium99 and a gamma probe.~   "
20832|NCT03294317|"~     The purpose of this research study is to assess the implant success proportion of the~     Medtronic SelectSecure MRI SureScan Model 3830 pacing lead at the bundle of His for His~     bundle pacing.~   "
20833|NCT03294304|"~     This is a multi-center Phase II study to determine the safety and efficacy of nivolumab when~     given in combination with cisplatin and gemcitabine as neoadjuvant treatment in patients with~     muscle-invasive bladder cancer (MIBC) prior to standard of care radical cystectomy. Patients~     will receive neoadjuvant treatment with nivolumab in combination with gemcitabine-cisplatin~     (GC) every 3 weeks for 4 treatment cycles over 12 weeks followed by standard of care radical~     cystectomy.~   "
20834|NCT03294291|"~     The purpose of this research study is to find the best way to decrease pain in children whom~     have had low abdominal surgery. Investigators will perform two technique;Caudal block or~     Quadratus lumborum block .The method used is often chosen by which one the doctor has more~     experience using. The Investigator plans to find out if one of the methods is more effective~     and/or safer than the other method.~      The results of this study will help learn how to best control pain in children having surgery~     low abdominal surgery.~   "
20835|NCT03294278|"~     A total of 150 patients will be randomized to perform catheter ablation or not in a 2:1~     fashion in selected patients with Brugada-related symptoms (Ablation+ICD arm 105 patients vs~     ICD only 45 patients).~   "
20836|NCT03294265|"~     Diabetes Mellitus (DM) affects patients' quality of life in different dimensions. Therefore,~     it is considered a priority to design and create specialized intervention programs in order~     to prevent and decrease complications. The peer support program studies have shown to~     Increase adherence to treatment and the proportion of patients with adequate long-term~     metabolic control.~      The benefits that these programs bring are the social and emotional support in the daily~     management of the disease through shared experiences and communication in a continuous way.~      There are only a few peer support programs in Mexico, thus it is required to investigate the~     effects of their implementation in our environment to promote empowerment and maintain~     long-term lifestyle changes. The present study has the objective to enhance self-care~     behaviors and health empowerment in patients with diabetes through peer support.~   "
20837|NCT03294252|"~     Current curative treatment of digestive peritoneal carcinomatosis consists of complete~     cytoreduction surgery associated with intraperitoneal chemotherapy. This treatment has~     important limits: a high morbimortality and the impossibility of repeating the sessions. The~     majority of patients are therefore treated with systemic chemotherapy, which despite its~     progress, remains palliative.~      Pressurized Intraperitoneal aerosol chemotherapy (PIPAC) has many advantages: under~     laparoscopy, low morbidity, good intratumoral penetration of cytotoxics, possibility of~     repeating the sessions and low financial cost.~      Therefore, the investigator propose a phase 1 study, in colorectal and stomach cancer, with~     oxaliplatin doses escalation in Pressurized Intraperitoneal aerosol chemotherapy. It would~     allow a better tumor response, with potentially few risks and thus improve survival in~     patients with digestive peritoneal carcinoses, increasing access to cytoreductive surgery.~   "
20838|NCT03294239|"~     To compare safety and efficacy of trans urethral and per cutaneous approaches in endoscopic~     management of bladder stones in boys younger than 14 years~   "
20839|NCT03294226|"~     Children from 6 months to 6 years are randomly allocated into AuraGain group or I-gel group.~     After anesthetic induction without neuromuscular blocking agent, assigned device in inserted~     by skillful anesthesiologist. The outcome measures are recorded and analysed.~   "
20940|NCT03292913|"~     The purpose of the study is to evaluate the effect of Positive Health Check (PHC), an online~     intervention that delivers tailored, evidence-based prevention messages to HIV positive~     patients, on improving clinical outcomes and retention in care of people who are HIV positive~     and have unsuppressed viral loads. The costs and processes of implementation will also be~     assessed to inform future dissemination.~   "
20842|NCT03294187|"~     Stroke places a major burden on health care and society. It often leads to a hemiparesis.~     Intensive stroke rehabilitation speeds up recovery. In daily practice, the financial and/or~     human resources to provide this intensive rehabilitation are often lacking. Applying~     modern-day tracking and feedback technology to encourage a self-administered, context~     specific training is expected to offer significant potential to increase intensity of~     practice. Up until now, there has been no randomized trial examining the effect of such an~     intervention on daily arm usage.~      The primary objective of this study is to determine the effect of wearing an activity~     tracking and multimodal feedback device for six weeks on self-reported daily life use of the~     paretic arm after stroke, when compared to control group stroke subjects wearing a~     hardware-wise identical sham device providing no feedback. The secondary aim is to examine~     compliance to use the device and the quantitative, qualitative and functional improvement of~     the paretic arm. It is hypothesized that participants in the experimental group show a higher~     change in self-reported daily life use of the paretic arm when compared to the control group~     both post intervention and at 6-week follow-up.~      ISEAR is a multicenter, assessor-blinded randomized controlled trial of 62 subjects beyond~     the first 3 months poststroke.~   "
20843|NCT03294174|"~     Peripheral nerve blocks with local anesthetics (LAs) have become an integral part of~     postoperative pain management particularly for patients undergoing major limb procedures such~     as such as Total Knee Arthroplasty (TKA). And while postoperative pain management in patients~     with a history of chronic opioid use may be difficult with systemic opioids because of opioid~     tolerance, there is anecdotal evidence suggesting that these patients may also be less~     responsive to LAs. Preliminary data from pre-clinical animal study show that there is a~     decreased LA potency in blocking sciatic nerve in opioid tolerant rats. And the decrease in~     LA potency is reversed by the knock-down of the beta4 subunits of Voltage-gated sodium~     channels along the sciatic nerves, suggesting the opioid induced intrinsic changes in the~     peripheral nerve as an underlying mechanism for opioid induced loss of LA potency.~      Study Goals: To determine the extent to which the changes in beta4 subunits of voltage-gated~     sodium channels are reflected in surgical patients.~      Experimental Design / methodology: This is a prospective, double-blind, active treatment~     controlled study. TKA Patients who receive nerve blocks will be grouped according to their~     history of pre-operative opioid use, and then tested for local anesthetic use for nerve~     block. Synovial tissues will also be collected for the analysis of beta4 subunits.~      Subject population: Patients who are scheduled for TKA procedure, and agree to receive~     peripheral nerve block for postoperative pain control, will be recruited for the study.~     Patients will participate in one of the three study groups: opioid naive, opioid history and~     opioid tolerant. 30 patients for each group with a total of 90 patients will be recruited.~      This study will not only determine the extent to which the preclinical findings are reflected~     in clinical patients, but also identify the underlying mechanisms that may suggest strategies~     for more effective post-operative pain management in the growing population of opioid~     tolerant patients~   "
20844|NCT03294161|"~     A clinical trial to asses efficacy and safety of Transition-state Analog Inhibitor of Human~     Purine Nucleoside Phosphorylase for topical use associated standard antimonial in the~     treatment of Cutaneous Leishmaniasis in Bahia, Brazil.~   "
20845|NCT03294148|"~     Participants with chronic back pain will complete an online prescreen. They will then be~     randomized to one of two different studies: a placebo vs. waitlist study or a psychotherapy~     vs. waitlist study, with randomization stratified on pain intensity, age, gender, and opioid~     use. Participants will then complete an in-person eligibility session, and eligible~     participants will be scheduled for the baseline assessment session. Following the baseline~     assessment session, participants will then be randomized to the treatment group or the~     waitlist group (with a ratio of 2:1 treatment:waitlist), using a computer-generated random~     sequence.~      This scheme will result in three equally sized groups—placebo, psychotherapy, and waitlist—as~     the investigators will collapse data from the waitlist arms in the two studies for analyses.~     The investigators do not use a standard three-way randomization because the investigators do~     not want placebo participants to think they are in a control condition. Thus, the~     investigators constrain participant's expectations to either injection vs. waitlist or to~     psychotherapy vs. waitlist.~      The placebo treatment is a subcutaneous injection of saline into the back. Participants will~     know that the treatment is a placebo, i.e., it is an open label placebo. Psychotherapy (8~     sessions) will be supervised by Alan Gordon and Howard Schubiner.~      Functional MRI brain imaging, self-reported clinical outcomes, and behavioral measures will~     be collected pre- and post-treatment. A brief follow-up survey will be sent at months 1, 2,~     3, 6, and 12 after the final assessment session. These will provide longer term data about~     the trajectory and durability of patient improvement.~      Additionally, a group of healthy controls, with no history of back pain, will complete the~     baseline assessment. They will serve as a comparison group to probe whether the patterns of~     observed brain activity is specific to CBP patients.~   "
20846|NCT03294135|"~     The purpose of this study is to continue the evaluation of antibody persistence through 11 to~     15 years after first booster with Tick-Borne Encephalitis (TBE) vaccine. This study will~     further investigate the booster response in subjects who will receive their second booster~     dose* in this study.~      * Any booster given in this study will be the second that the subject has received (with~     regard to the follow-up of the previous study).~   "
20847|NCT03294122|"~     The main idea behind MICRO-LEARNER is to provide new insights about the response of healthy~     tissues to radiation by using information from the micro-environment obtained by biological~     measurements and imaging. This new knowledge will be included in current available predictive~     models of radio-induced toxicity, thus allowing to add unique biological characteristics of~     patients to dosimetry and treatment/clinical related variables.~      MICRO-LEARNER focuses on prostate cancer (PCa) and head-and-neck cancer (HNCa). For both~     cancers, radiotherapy is effectively used as curative treatment, in single modality or within~     a multidisciplinary approach including surgery (PCa) and/or chemotherapy (HNCa). Prediction~     and reduction of radio-induced side effects are becoming a priority: for PCa, high survival~     rates should be accompanied by a very low rate of moderate/severe toxicities; for HNCa, there~     is the need to tailor radiation dose according to disease recurrence risk profile. The shared~     aim of both cancers is to balance the improvement in outcome with a well-tolerated toxicity~     profile.~      Recent research indicates that the intestinal/salivary bacteria are strongly suspected of~     being very important in mediating the response to inflammation and lesions. Although their~     balance deeply changes during radiotherapy, studies done so far in the field of the~     microbiota-host relationship in radiotherapy have not addressed their role in insurgence of~     radiation toxicity.~      In this study, the investigators will assess how microbial populations evolve and how this~     influences the host and radiation induced toxicity in a significant number of patients.~     Moreover, the individual response at the tissue microstructure level, through analysis of~     images with advanced bioengineering techniques, will be determined.~      Results from this research, besides suggesting new ways to predict patients at risk of~     relevant side-effects, may also suggest possible treatments to change the baseline microbiota~     of patients at high risk or to modify it during therapy, in order to mitigate toxicity.~     Understanding the microbiota-radiotherapy interaction may thus lead to novel, effective and~     inexpensive ways of assessing and managing complications of cancer treatment.~   "
20848|NCT03294109|"~     A blinded randomized control trial in living kidney donors. The study group will receive a~     liposomal bupivacaine Trans Quadratus Lumborum (TQL) block after the induction of general~     anesthesia. The following study variables will be collected postoperatively following arrival~     in the post-anesthesia care unit. Current and maximum intensity pain scores will be~     documented by nurses in Electronic Health Record (EHR). Total opiate dose consumed every 24~     hours will be collected from the EHR and pain diary after discharge. Patient satisfaction~     will be evaluated using the Revised American Pain Society Patient Outcome Questionnaire~     (APS-POQ-R) 24 hours' post-procedure. Incidence of nausea will be extracted from nursing~     notes.~   "
20941|NCT03292900|"~     To assess the effectiveness of the use of a patient's genes to predict which hypertension~     therapy is successful~   "
20942|NCT03292887|"~     The purpose of this study is to collect data that will increase understanding of Hunter~     syndrome. The data from HOS may provide guidance to healthcare professionals about disease~     treatment options.~   "
20850|NCT03294083|"~     This is a Phase 1b, open-label, multi-center, dose-escalation trial of Pexa-Vec plus REGN2810~     in patients with metastatic or unresectable renal cell carcinoma (RCC). The trial consists of~     a dose-escalation stage, where the maximum feasible dose of Pexa-Vec in combination with~     REGN2810 will be determined, followed by an expansion stage. During the expansion patients~     will receive REGN2810 alone or in combination with Pexa-Vec, which will be administered~     either through intravenous (IV) or intratumoral (IT) injection.~   "
20851|NCT03294070|"~     24-week open clinical trial to assess tolerability and effect on pressure, hemodynamic~     parameters and arterial rigidity of the combined treatment based on Fimasartan 60 mg and~     amlodipine besylate 5 mg given once daily in patients with arterial hypertension in stages~     2-3~   "
20852|NCT03294057|"~     This study verifies efficacy of collaborative care with Smart Health Management Program~     developed for patients with chronic illness. The aim of the study is to observe the changes~     in clinical indicators, quality of life and health related behaviors when providing~     self-management programs with ICT for chronic disease patients.~   "
20853|NCT03294044|"~     This study verifies efficacy of Smart Health Management Program developed for patients with~     chronic illness. The aim of the study is to observe the changes in clinical indicators,~     quality of life and health related behaviors when providing self-management programs with ICT~     for chronic disease patients.~   "
20854|NCT03294031|"~     Although Pilates has been proposed as a useful rehabilitation strategy in PD, research on its~     feasibility and potential effects on the motor symptoms and balance with this population is~     scarce. Some works have included Pilates as part of combined exercise session interventions,~     but information concerning their specific effects was not provided. Under these~     circumstances, this study aims at identifying the effects of adding Pilates as part of a~     conventional exercise rehabilitation program on the motor symptoms and static balance of PD~     persons. Participants (n=15) were assigned to a Pilates (PG) or to a conventional exercise~     group (CG) and performed one land-based and one water-based exercise session per week for 14~     weeks. The MDS-UPDRS and a stabilometer were used to assess the impact of the intervention on~     the participant´s motor symptoms and static balance.~   "
20855|NCT03294018|"~     This a prospective study when the clinician decides to use sugammadex, heart rate will be~     recorded every minute for 15 minutes following its administration. If bradycardia occurs and~     a clinical decision is made to treat it, the medications and doses used will be recorded.~   "
20856|NCT03294005|"~     Iodine ingestion insufficiency was widespread existence in the 50's in Taiwan, induced the~     hypothyroidism with the popular name the big neck. After many experts study and evaluation,~     goiter was gradually disappeared after salt adding iodine in the 60's. But the nodule of the~     thyroid gland was widespread on the Taiwan island. This situation was a particular victim in~     living in the mountainous area inhabitant. The middle area populaces suffer from the thyroid~     gland disease really popular than other areas. Recently literature reported that the cancer~     rate of thyroid gland rises gradually. In according to the statistics, thyroid cancer~     prevalence probably has 10% in the nodular goiter.~      The major early preliminary diagnosis of the thyroid cancer is thyroid fine-needle aspiration~     cytology (FNAC), but this technique must to have skilled clinical puncture's doctor and to~     have special training cytological pathology doctor. Therefore, if we can have simple fast~     screening tool and can make up this insufficiency, then we can achieved the fast diagnosis,~     rapid processing, the promotion diagnosis and treatment quality and promotes the survival~     percentage. The thyroid ultrasonography (Thyroid US) is one universal, fast, cheap, and the~     simple diagnosis nodular goiter tool. If we can friendly use this tool, we can early~     diagnosis & management this disease.~      This research collect subjects from Jan 2002 to Dec 2016 under procedure of thyroid US, FNAC~     and thyroidectomy. Preliminary design index of thyroid gland tumor score (TTS) was to survey~     and analysis.~   "
20857|NCT03293992|"~     This is a Phase I, multi-center, randomized, adaptive, investigator/patient-masked,~     placebo-controlled, parallel multiple-ascending dose study (Part A) with an extension~     including up to two selected doses from Part A and latanoprost 0.005% as active comparator~     (Part B).~   "
20858|NCT03293979|"~     It appears that the heavyness of flu pathology, the diagnosis limits and the validity of it~     was well studied in the last years.However, the economical impact and the organisation~     benefit in emergency service is not yet evaluated Our purpose is to study the impact of~     implementation of fast flu diagnosis by molecular biology available in emergency service in~     the economic field .~   "
20859|NCT03293966|"~     The continuity of the medicinal care between the city and the hospital stays a major~     organizational stake and of safety of patients' therapeutic care.This takeover is more~     complex when it concerns pathology needed lots of hospitalization and included the~     intervention of multiple healthcare practionners. This is clearly the case of cancer~     coverage.~      The optimization of the therapeutic suppor in town is based on pharmaceutical advice~     strengthening but also on the pharmaceutical analysis to check the entire treatments'~     prescription and eventual medicinal interactions which ensue from it.That's why it's~     important to have a medicinal conciliation that takes into account all the medecine taken or~     have to be taken by the patient.~      A specific support was developped by nurses , doctors and pharmacist ; it's a care~     coordiantion card that can be put easely in a pocket by the patient.~      The aim of the study is that this card can be also used as a communication tools by sharing~     the prescription done at the release of hospital by using an IT link (flea datamatrix) for~     the patients Via the use of an IT link (flea datamatrix) for the patients whose pathology is~     complex in term of extra hospital coverage.~   "
20860|NCT03293953|"~     The main purpose of the present study is to compare the diagnostic performance of three~     non-invasive stiffness imaging methods (TE, SWE and MRE) in a consecutive cohort of patients~     with chronic viral C hepatitis or co-infected by HCV+ Human Human Immunodeficiency Virus~     (HIV).~   "
20861|NCT03293940|"~     This is a prospective, randomized, parallel-group, treatment control trial with cross-over~     options performed at four sites. The purpose of this study is to assess the efficacy and~     safety of cryoablation therapy for the treatment of post mastectomy pain syndrome.~   "
20862|NCT03293927|"~     The purpose of this study is to learn how 2 medications (fentanyl and dexmedetomidine) affect~     how sick children think and interact with their environments.~   "
20863|NCT03293914|"~     This study is examining the feasibility of implementing an occupational therapy intervention~     addressing diabetes management in a primary care clinic within the Los Angeles County~     Department of Health Services (LAC-DHS), as well as the impact of this intervention approach~     on clinical outcomes, efficiency and patient-centeredness of care. This implementation~     science study is evaluating two emerging trends in healthcare delivery: (1) the integration~     of nontraditional providers into primary care medical home (PCMH) settings to facilitate the~     delivery of high-quality, comprehensive primary care while reducing the burden on physicians;~     and (2) the potential value of using occupational therapists to address chronic disease~     management in this setting~   "
20864|NCT03293901|"~     This randomized cross-over study will identify physiological factors that underlie changes in~     bone metabolism that could affect skeletal injury risk, to include increases in parathyroid~     hormone (PTH) in response to militarily relevant exercise in females. The primary objective~     is to determine the hormone and calcium (Ca) response to multiple bouts of load carriage~     exercise in females. The investigators hypothesize that PTH will increase after multiple~     bouts of load carriage exercise and this increase will be due to disruption in Ca kinetics,~     specifically either a decrease in fractional intestinal Ca absorption (FCA) or changes in~     bone formation and/or resorption.~   "
20865|NCT03293888|"~     This is a pilot, observational study to evaluate the intraoperative sensitivity of the Chaos~     Wand in detecting tumor tissue with glioblastoma disease.~   "
20866|NCT03293875|"~     The proposed project is a research collaboration between the University of Texas at El Paso,~     The Alliance for Border Collaboratives and Programa Companeros to adapt, implement, and~     evaluate a multi-level community-based HIV prevention intervention (Project Encuentro). The~     intervention will target active heroin and crack users and consists of increasing access to~     HIV testing via a social network HIV testing component and reducing sexual and drug use risk~     via a peer network brief behavioral Intervention. Encuentro also consists of conducting~     community awareness meeting to target structural factors affecting HIV risk. The intervention~     was developed in an area severely affected by violence and stigma towards drug users, El~     Salvador, which makes it particularly suitable for adaptation to meet the needs of drug users~     living in the proposed intervention site, the U.S.-Mexico border. The proposed intervention~     site also has been severely affected by violence which has curtailed any prior attempts to~     reduce the risk drug users' HIV risk. Violence has worsened structural factors which affect~     HIV risk such as, increasing police persecution and stigma and reducing access to resources.~     In our proposed project, we will engage in formative research to understand the context of~     HIV risk of drug users in the border region post violence and adapt the intervention~     accordingly. Findings will allow the investigators to tailor intervention components to meet~     the needs of drug users in the region. Subsequently, the investigators propose to test~     intervention effectiveness and evaluate implementation barriers and facilitators. To~     accomplish project aims we will use a mixed qualitative, quantitative approach. The~     investigators will begin with a formative phase by conducting in-depth interviews with drug~     users (n = 40) living in the region to understand how the context of drug use risk changed as~     a result of the violence and will administer a social network survey (n = 200) to~     characterize the configuration of risk networks. Findings will yield the necessary~     information to culturally adapt the intervention to meet the needs of drug users in the~     region and will help the investigators focus recruitment efforts where the riskiest networks~     are located. After the intervention is adapted with the help of the community advisory boards~     and the community coalitions, the investigators will implement the intervention and will~     assess the effectiveness and reach via 6 cross-sectional surveys administered to drug users~     (n=1,200). The investigators will assess the process of implementation by conducting~     ethnographic field notes of all intervention activities including community engagement and~     Community Advisory Board and coalition meetings. The investigators will assess the fidelity~     and quality of the intervention. Lastly, the investigators will conduct key informant~     interviews with key stakeholders involved in the project and interviews and observations will~     be coded to reflect key systems factors related to successful implementation of intervention~     components in two intervention sites (El Paso, Texas and Ciudad Juarez, Mexico). Findings~     will be highly significant as the investigators will be conducting parallel research on the~     effectiveness of interventions shown to be effective in Latino drug users in two very~     different contexts: El Salvador and the U.S-Mexico border. Findings will elucidate~     implementation challenges and barriers and such information can then be used to assess the~     effectiveness of diverse implementation strategies in organizations working to serve the~     needs of Latino drug users.~   "
20867|NCT03293862|"~     Abdominal wound dehiscence elicit high morbidity and mortality. This complication may arise~     in more than 8.5% of high-risk patients. Addressing risk factors and optimizing surgical~     technique are guarded as mainstay measures for prevention, but their efficacy is~     questionable. The aim of this study is to analyze the influence of using a polypropylene~     onlay prophylactic mesh on the incidence of abdominal wound dehiscence and associated~     complications.~   "
20868|NCT03293849|"~     In this randomized clinical trial, patients with Stage IV solid tumors will be enrolled in a~     patient navigator-led generalist palliative and supportive care intervention or in usual care~     led by their treating physician. The patient navigator will assess the patient's palliative~     and supportive care needs using standardized quality of life and symptoms questionnaires and~     present this assessment to a multidisciplinary team composed of oncologists and palliative~     care specialist. The multidisciplinary team will develop a personalized supportive care plan~     for the patient which will then be presented and discussed by the patient navigator. Those~     interventions which are accepted by the patient will be implemented by the patient navigator,~     who will also provide education and teaching. The patient navigator will also help eligible~     patients complete advanced directives according to local rules and regulations. The patient~     navigator will follow the patients both in person and by telephone to ensure that the~     recommended interventions have been implemented. Three months after enrollment the patients~     will undergo quality of life and symptom assessment once again, and the implementation of~     interventions will be recorded.~   "
20869|NCT03293836|"~     The aim of this study is to analyze the effect of intravenous therapy with radiofrequency for~     superficial and perforating venous insufficiency versus compression therapy with multilayer~     banding in patients with active venous ulcer. This is a controlled, randomized prospective~     clinical trial. People with venous ulcers and primary venous insufficiency in superficial and~     perforating venous system will be studied. Participants will be divided into two experimental~     groups: compression therapy alone, and compression therapy associated with superficial and~     perforating venous system ablation. Clinical aspects, improvement in patients' quality of~     life and interventions cost-effectiveness will be analyzed. Patients will be followed for 12~     months after ulcer healing.~   "
20870|NCT03293823|"~     Emerging evidence from social neuroscience suggests that prefrontal cortex (PFC), insular and~     anterior cingulate cortex (ACC) regulate social and emotional responses to acute threats to~     social connectedness among young adults. Deficient neural reserve or overused neural~     compensation resulting from neurodegeneration is commonly observed in these frontal regions~     in old age. This aging-related neural depletion may have implications for how older adults~     respond to social threats, potentially increasing maladaptive emotional and social behavioral~     responses, such as social anxiety and social avoidance, which contribute to social~     disconnectedness. The central hypothesis is that cognitive deficits and associated~     aging-related 'neural depletion' in the frontal regions will contribute to maladaptive~     social-emotional responses to a social stressor -- social exclusion. Ultimately, maladaptive~     responses to acute social stress, such as social anxiety and avoidance, can compromise social~     connectedness by increasing social strain and isolation. The investigators have recently~     developed a neuroplasticity-based cognitive training program, called vision-based speed of~     processing (VSOP) training, targeting multiple aspects of cognitive capacity (e.g.,~     attention, working memory and inhibition) and incorporating the speed component to improve~     the efficiency of these cognitive processes. VSOP training also targets several neural~     networks seeded in ACC and insular (default mode network) or PFC (the frontal-striatal~     network and central executive network). These networks also overlap with neural substrates of~     emotion regulation. Notably, VSOP training appears to improve emotion regulation, as~     depressive symptoms were reduced in older adults following VSOP training. Finally, the~     autonomic nervous system (ANS), critical to stress adaptation, is regulated by these frontal~     regions. The objective of the proposed pilot study is to provide proof-of-concept for the~     hypothesis that improvements in older adults' cognitive capacity, frontal regions' neural~     efficiency, and ANS function via the VSOP training will be associated with more adaptive~     social-emotional response to social exclusion, which, in turn, should confer longer-term~     protection for older adults' sense of social connectedness. Randomized Controlled Trial~     Design: 30 older adults will be randomly assigned to engage in 6-week VSOP training, or to an~     active control group. Differential changes from baseline to post-training in cognitive~     capacity, neural efficiency, and ANS function, and sense of social connectedness, will be~     compared between VSOP control groups. A social exclusion paradigm ('cyberball' task) will be~     conducted post-training to evaluate VSOP training effects on social-emotional responses to~     social exclusion, including anxiety and motivation for social affiliation.~   "
20871|NCT03293810|"~     Lipoprotein lipase deficiency (LPLD) is a rare autosomal recessive disorder, characterized by~     loss-of function mutations in the LPL gene, leading to the inability to produce functionally~     active lipoprotein lipase (LPL). LPL is the key enzyme in the metabolism of triglyceride~     (TG)-rich lipoproteins (chylomicrons (CM) and very low-density lipoproteins (VLDL)). LPLD~     results in extremely high concentrations of circulating TG-rich lipoproteins.~      No drug therapy for LPLD is currently available. Clinical management of LPLD patients~     consists of severe dietary fat restriction and the use of medium-chain triglycerides to~     substitute for normal dietary fats.~      Alipogene tiparvovec (Glybera®) received marketing authorisation from the European commission~     on 25 October 2012. Glybera® aims to correct lipoprotein lipase deficiency sufficiently to~     decrease the morbidity and lower the risk of inherent complications of LPLD, in adult~     patients genetically diagnosed with LPLD.~      The Glybera Registry is designed to collect the long-term safety and efficacy data of~     GLYBERA®~   "
21061|NCT03291340|"~     The purpose of this study is to use transcanial doppler (TCD) ultrasound to look for possible~     risk factors for ischemic brain injury. We will perform contrast TCD with agitated saline~     contrast to identify and contrast right-to-left shunt (RLS) and breath holding to assess~     cerebrovascular reactivity (CVR) in the elderly.~   "
20872|NCT03293797|"~     Symptoms of depression and anxiety are extremely prevalent in the population. Unfortunately,~     patients often face barriers to accessing mental health care, particularly psychotherapeutic~     interventions, including long wait-times and demanding therapeutic protocols. For instance,~     Mindfulness-Based Therapy (MBT) has demonstrated effectiveness at decreasing symptoms of~     depression and anxiety, and improving wellbeing; however, 'traditional' MBT can demand over~     30 hours of clinical time, and 50-60 hours of homework, all of which can be barriers to care.~     A pilot, uncontrolled study conducted at Sunnybrook illustrated the potential feasibility /~     efficaciousness of a novel abbreviated MBT in improving hospital staff wellbeing. The goal of~     this controlled study is to further test feasibility and acceptability of this intervention~     to reduce depressive / anxious symptoms, reduce stress and improve wellbeing in outpatient~     mood/anxiety patients. If efficacious, this Abbreviated MBT could reduce barriers to~     accessing mental health care.~   "
20873|NCT03293784|"~     This is a Phase 1b, open-label study of immune checkpoints inhibitors Nivolumab+Ipilimumab~     administered in combination with the anti-TNF-α either Infliximab or Certolizumab, in~     patients with advanced melanoma.~   "
20874|NCT03293771|"~     The intent of this mixed methods study for transgender women after gender confirmation~     surgery is to characterize and subsequently create a validated screening questionnaire for~     postoperative urologic and pelvic floor symptoms. For individuals who seek gender-confirming~     treatment, about 13% undergo genital surgery for cosmetic purposes with or without~     gonadectomy, and this number is increasing. Patient satisfaction following surgery is high,~     particularly regarding sexual and cosmetic outcomes; however, unexpected negative functional~     outcomes such as bowel and bladder dysfunction and pelvic organ prolapse impact overall~     patient satisfaction. The available information suggests that 16-33% of patients experience~     incontinence postoperatively, with stress predominance, 32-47% experience abnormal voiding,~     and 24-66% experience overactive bladder symptoms. Outside of the typically assessed voiding~     symptoms, unique complaints of MTF postoperative patients include obstructive voiding~     symptoms due to urethral stenosis, persistent perimeatal erectile tissue, prostatic~     hypertrophy, and irritation from neovaginal tissue. Additionally, may of these patients~     develop symptomatic neovaginal prolapse, requiring re-suspension. We suggest that further~     clarification regarding MTF postoperative urologic and pelvic floor complaints can be~     achieved via a mixed methods approach. By using focus group interviews to create specific~     evaluative questions for this unique population, we can then prospectively assess patients~     undergoing surgery via a national multicenter sampling strategy. The goal of the study is to~     better understand the unique symptoms these women experience and create a validated, reliable~     screening questionnaire to monitor patients after surgery.~   "
20875|NCT03293758|"~     The NYU Human Microbiome Study Cohort is designed to improve understanding of the role of~     human microbiome in health and disease. This study will serve as a critical NYU biorepository~     resource for research on human genetics and the microbiome in health and disease~   "
20876|NCT03293745|"~     The purpose of this study is to compare the effectiveness of Cognitive-Behavioral Therapy~     (CBT) for insomnia conducted face-to-face with a therapist versus CBT for insomnia conducted~     using Internet-based videoconference technology.~   "
20877|NCT03293732|"~     The objectives of this study were to assess the safety and tolerability of DCB07010 when~     given intranasally at escalating dose levels of 7.5μg, 15μg, 30μg and 45μg, in combination~     with 22.5μg of influenza HA antigen (7.5μg HA of each of three strains) and to generate~     sufficient immunogenicity data to enable dose selection for larger and more definitive Phase~     2 studies.~      This was a single center, double-blind, randomized (2:1), dose-escalation study to assess the~     safety, tolerability and immunogenicity of 4 different vaccine-adjuvant doses in comparison~     to influenza HA alone. The 4 treatment cohorts were given DCB07010 in a dose- escalating~     manner.~   "
20878|NCT03293719|"~     Prospective Post-Market Clinical Follow up study according to MEDDEV 2.12/2 rev2 of the~     European Union. Patients receiving the primary knee implant BPK-S UC as primary implant in~     either variant ceramic or CoCr (metal) are eligible for the study and will be followed up for~     5 years after implantation or until revision of the prosthesis, whichever occurs first.~     Demographic data will be collected together with data regarding safety and benefit at defined~     timepoints (preoperative, intraoperative and at 3 months, 1 year, 2 years and 5 years after~     implantation).~      Patients will be divided in 2 cohorts (ceramic and metal) and stratified by age.~   "
20879|NCT03293706|"~     The study is single-blind with a randomized, cross-over design to evaluate gastrointestinal~     tolerance of carbohydrate blends.~   "
20880|NCT03293693|"~     The overall aim is to investigate the intake of beta-glucan in relation to glucose metabolism~     and satiety in a postprandial study with healthy subjects. The potential effects will be~     related to changes in the gut microbiota, the circulating levels of short chain fatty acids,~     inflammation and gene expression in peripheral mononuclear blood cells~   "
20881|NCT03293680|"~     This is a multi-center phase II trial of intravenous (IV) Pembrolizumab MK-3475 in subjects~     older than 70 years with advanced Non-small cell Lung Cancer (NSCLC) expressing Programmed~     death-ligand 1 (PD-L1). 82 patients will be enrolled in this trial to examine the efficacy,~     the impact on geriatric assessments, the quality of life and the self-reported outcomes.~   "
20882|NCT03293667|"~     In rheumatoid arthritis (RA) the clinical response to anti-TNFα is related to an increase in~     the number or in the function of Treg lymphocytes in the peripheral blood of patients. This~     observation suggests the central role of Tregs in homeostasis of the immune response during~     RA.~      In the literature the Tregs frequency and phenotype in the peripheral blood are well~     documented, however the analyses done on the Tregs in inflamed environment are still~     fragmentary or disparate.~      In this project Tregs phenotype as well as expression of several transcripts will be analysed~     in order to better characterize the Treg cell subsets within the synovial fluid. Moreover,~     the local inflammatory cytokines (TNF, IL-6 and IL-1) may affect both the phenotype and the~     suppressive function of these Tregs and a comparison between peripheral and tissue Tregs will~     allow us to better understand the cause of functional loss.~      Outcomes:~      Primary outcome: Identification and characterization of the Tregs subpopulation present in~     the synovial fluid for RA patients suffering an episode of acute arthritis.~      Secondary outcomes: compare the phenotypic and expression profile of the Tregs present in the~     synovial fluid with the Tregs present in the peripheral blood of RA patients suffering from~     an episode of acute arthritis.~   "
20883|NCT03293654|"~     Randomized, double blind, parallel group, single dose, 3 arm study to investigate and compare~     the PK, safety and immunogenicity profile of MB02 with US and EU Avastin® in healthy male~     subjects.~      During the course of the study, the similarity in pharmacokinetics will be assessed by~     sampling the levels of drug in the blood, and by comparing these levels among the different~     administration arms. Safety, tolerability, and immunologic response to the administered drugs~     will also be evaluated throughout.~   "
20884|NCT03293641|"~     Zinc is a nutritionally essential trace element found in previous studies to reduce growth~     retardation and improve immune function, which may also result in decreased incidence of~     infectious diseases including malaria, pneumonia and diarrhea. Sickle Cell Disease (SCD)~     patients are known to be susceptible to zinc deficiency and appear to benefit from zinc~     supplementation. The proposed pilot research project aims to investigate the influence of~     zinc supplementation on incidence of malaria infections, incidence of bacterial infections~     and investigate the influence of zinc supplementation on morbidity in children with SCD in~     western Kenya. The differences in incidence of morbidity and other secondary endpoints will~     be compared between the zinc group and the control group.~   "
20885|NCT03293628|"~     The LEEP conization is commonly used for cervical pathologies treatment. The techniques for~     hemostasis usually used are: cautery, Monsel's solution and vaginal pack. Actually, there is~     no consensus about the best technique and there is not much information that validates the~     use of some of that. To compare the use or not of vaginal pack as methods of hemostasis after~     LEEP conization for management of cervical lesions.~   "
20886|NCT03293615|"~     Dermatomyositis (DM) patients experience muscle weakness and low aerobic capacities, which~     are associated with poor health status and increased mortality. The origin of this muscle~     impairment remains unknown.~      The investigators hypothesize that mitochondria functioning is impaired in DM muscle and~     links with exercise capacities.~   "
20887|NCT03293602|"~     This feasibility exploratory study objective is to assess the ability of combined MRI BOLD~     and 18F-MISO PET imaging to visualize tumor hypoxia compare to histological results obtained~     after radical prostatectomy in order to, in time, be able to identify patient with bad~     prognostic and to offer them the best therapeutic strategy.~   "
20888|NCT03293589|"~     Treatment of patients with end-stage renal disease and critical limb ischemia still poses~     challenges to vascular medicine due to limited survival, comorbidities and infrapopliteal~     involvement of arteriosclerosis in these patients.~      Most optimal vascular therapy mode has not been finally decided in these patients.~      Therefore retrospective analysis of patients receiving open surgical and endovascular~     revascularisation was performed.~   "
20889|NCT03293576|"~     The study evaluates the use of implementation intentions to increase self-efficacy and reduce~     injecting risk behaviour in a sample of injecting drug users on treatment for hepatitis C~     (HCV). The overall aim is to reduce HCV reinfection rates. The primary objective is to~     identify lower injecting risk behaviour scores in patients on treatment for hepatitis C~     receiving the psychosocial intervention compared to the same patient group assigned to the~     control group.~   "
20890|NCT03293563|"~     Within the framework for kidney cancer care, with the recent diversification of treatment~     modalities of these tumors and the deployment of the concept of multidisciplinary team, it~     was considered necessary to adapt the research tools to reality of health-care for patients~     with kidney cancer.~      UroCCR is the French research network for kidney cancer, funded by the French National Cancer~     Institute as part of the call for projects for clinical and biological databases (BCB).~     Depending on the case presentation and disease evolution, more than a thousand of different~     variables can be recorded. At the same time, biological samples (plasma, urine, healthy and~     tumor tissues) are collected.~      This database contains a considerable number of information and high added value since it is~     the result of multiple expertises that make it not only a multidisciplinary tool but also~     multicenter, allowing fundamental, translational and clinical research.~   "
20891|NCT03293550|"~     As the population ages and medical progress is made, many elderly patients that previously~     would not have been candidates for surgery are now undergoing operations. In this group of~     older patients, brain dysfunction after anesthesia and surgery is well recognized and~     categorized into two distinct clinical entities; Post-operative cognitive delirium (POD) and~     post-operative cognitive dysfunction (POCD).~      Delirium is an acute and fluctuating deterioration in attention accompanied by either a~     change in cognition or arousal and is often diagnosed by criteria established in the~     Confusion Assessment Method (CAM). Delirium can present as hypoactive (decreased alertness,~     motor activity and anhedonia), as hyperactive (agitated and combative) or as mixed forms. Age~     and the type of operation are the major risk factors.~      Post-operative cognitive dysfunction (POCD) is a term used to describe subtle changes in~     cognition, such as memory and executive function. The most commonly seen problems are memory~     impairment and impaired performance on intellectual tasks. In severe cases, it can lead to~     inability to perform daily living functions. It was previously found that the presence of~     cognitive dysfunction 3 months after non-cardiac surgery was associated with an increased~     mortality. The mechanisms leading to cognitive impairment after anesthesia and surgery are~     not yet fully clear. The risk factors are related to patient characteristics, type of~     operation and anesthetic management.~      Despite its limitations over-anesthesia as monitored by BIS was at-least correlative with~     POD. Therefore it is hopeful that an even more precise evaluation of the level of anesthesia~     will improve POD prediction (and thereby prevention) even further.~      On the other hand the measure of depth of anesthesia by itself does not provide sufficient~     prediction for POCD. In POCD a major role has been assigned to hippocampal damage.~      The investigators have recently demonstrated that temporary hippocampal interruptions are~     manifested by interhemispheric desynchronization, which are recognized by our new algorithm,~     which monitors electrophysiological markers of attention and of perception.~      The investigators have developed a unique algorithm for analyzing EEG based on the concept of~     monitoring perception and attention and their interhemispheric synchronization.~      The aims of this proof of concept study are: (i) to find-out whether interhemispheric~     desynchronization of attentional processes is associated with POCD; (ii) to find out whether~     the level of anesthesia, is linked primary to POD and secondary to POCD.~   "
20892|NCT03293537|"~     We want to determine if patients with dementia show any kind of Emotion while they look at a~     defined selection of photos. These are photos taken from a international image-platform and~     mixed with photos (of the patients) that show personal objects, personal events, etc.~      While the photos will be presented each a few seconds the skin conductance and the heart rate~     will be measured. We want to find out if there is any emotion measurable while showing the~     photos.~   "
20893|NCT03293524|"~     The goal of this clinical trial is to assess the safety and efficacy of GS010, a gene~     therapy, in improving the retina functional & structural outcomes in subjects with LHON due~     to the G11778A ND4 mitochondrial mutation when vision loss duration is present up to one~     year.~   "
20894|NCT03293511|"~     The main aim of the study is to examine whether the effects of intranasal oxytocin on~     eye-gaze behavior towards social stimuli are modulated via individual differences in trait~     autism~   "
20895|NCT03293498|"~     This is a Phase 1/2, randomized, observer-blinded, active-controlled trial. Approximately 330~     eligible subjects will be enrolled and randomized into 1 of 3 treatment groups as shown in~     the Trial Design table below. Each group will consist of approximately 110 subjects total,~     stratified by age, gender, and history of receipt of 2016 - 17 influenza vaccine. On Day 0,~     subjects in Groups A and B will be administered an IM injection of NanoFlu at one of two dose~     levels; subjects in Group C will receive the preconfigured comparator (Fluzone HD) at the~     manufacturer's recommended dose and volume. On Day 21, all Group A and B subjects will be~     administered a rescue injection with a licensed seasonal influenza vaccine, while all Group C~     subjects will be administered an injection with sterile saline placebo to maintain trial~     blind. Trial follow-up for each subject will span approximately 1 year from the Day 0.~   "
20896|NCT03293485|"~     The study will evaluate the efficacy and safety of imipenem+cilastatin/relebactam (IMI/REL,~     MK-7655A) in Japanese participants with complicated intra-abdominal infection (cIAI) or~     complicated urinary tract infection (cUTI).~   "
20897|NCT03293472|"~     Consenting patients, scheduled for orthopaedic surgery under spinal anesthesia will be~     randomly assigned (1:1) to receive ropivacaine or bupivacaine as a single shot before the~     start of surgery, followed by bolus doses of the same local anesthetic as required during the~     surgery, and continuous infusion of the same local anesthetic for 24 hours postoperatively.~      Primary Outcome Measures: Evaluation of changes in concentrations of glutamate in the~     cerebrospinal fluid and in the blood. Secondary outcomes: : Evaluation of changes in~     concentrations of selected mediators of inflammatory response (IL-1β, IL-6, TNF and others)~     and selected chemokines as markers of the glia damage.~      Hemodynamic stability during the surgery, and efficacy of postoperative analgesia will be~     also evaluated.~   "
20898|NCT03293459|"~     The spontaneous gastrorenal shunt is occluded in the Balloon Occluded Retrograde Transvenous~     Obliteration (BRTO) procedure resulting in diversion of blood flow toward the portal~     circulation and in turn the liver. According to this investigator hypothesise that BRTO~     improves liver volume and function along with beneficial effect on other organ systems by~     decreasing ammonia and improving hepatopetal flow. All cirrhotics with large shunt(>10mm) and~     raised ammonia levels and will be randomized to receive standard medical treatment and those~     with BRTO. Investigator will assess organ functions and liver regenerative potential pre and~     post(after 3months) procedure.~   "
20899|NCT03293446|"~     In this study the effect of an acute acid load on the intrarenal renin angiotensin-system is~     evaluated in patients with chronic kidney disease and healthy controls~   "
20900|NCT03293433|"~     One of the main challenges of thoracic oncology lies in earlier diagnosis of lung cancer to~     improve survival rate, wich is about 15% at 5 years. This poor prognosis is often linked to~     late diagnosis. Efforts are being made worldwide to offer testing in patients at risk or~     earlier diagnosis of lung cancer in order to offer the patient curative treatments. Indeed,~     supported at the stage of nodule (less than 3 cm lesion), lung cancer is curable by surgery~     in 80% of patients. Nevertheless, there are many differential diagnoses and access to these~     lesions is often difficult and risky. In this context, the management of pulmonary nodules,~     which can be either benign lesions or beginners cancers, is a real challenge for~     pulmonologists and thoracic oncologists every day: it is important not to disregard a~     potentially operable nodule and avoiding offer patients invasive procedures for benign~     nodules. Indeed, many procedures (endoscopy, puncture under scanner, thoracotomy) are made to~     determine if suspicious nodules are benign or not. In the large National Lung Screening~     Trial, 28% of the procedures were associated with complications (including 11% classified~     severe and 16 deaths). It is therefore essential to develop non-invasive tools to refine~     treatment decisions.~   "
20901|NCT03293420|"~     Observational retrospective study that included all patients meeting the inclusion criteria~     from 1st January 2014 to 31st December 2015.~      The objective of the study is to describe and compare two populations of patients with severe~     traumatic head injury arriving under sedation in the Department in whom the sedation was not~     continued.~   "
20902|NCT03293407|"~     The main aim of the observational VENTASTEP study is to investigate the potential use of~     device-based measures as outcome-surrogates for clinical assessments in PAH-patients using~     the new Breelib nebulizer in a real life setting.~   "
20903|NCT03293394|"~     Amyotrophic Lateral Sclerosis (ALS) is a motor neuron disease, which is a group of~     neurological disorders that selectively affect motor neurons, the cells that control~     voluntary muscles of the body. The disorder causes muscle weakness and atrophy throughout the~     body due to the degeneration of the upper and lower motor neurons. Current drugs approved for~     ALS treatment only modestly slow disease progression.~      Transcranial direct current stimulation (tDCS) is a non-invasive technique, which has been~     demonstrated to modulate cerebral excitability in several neurodegenerative disorders and~     modulate intracortical connectivity measures.~      In this randomized, double-blind, sham-controlled study, the investigators will evaluate~     whether a two-weeks' treatment with bilateral motor cortex anodal tDCS and spinal cathodal~     tDCS can improve symptoms in patients with amyotrophic lateral sclerosis and modulate~     intracortical connectivity, at short and long term.~   "
20904|NCT03293381|"~     Fluoroscopy guided EMB and EAM guided EMB on all patients meeting existing guidelines for~     biopsy.~   "
20905|NCT03293368|"~     After signing the informed consent, the participant will be allocated to either intervention~     or control group, then each participant in the intervention group will receive intralesional~     injections of platelet rich plasma extracted from their own blood in each visit as following:~        1. 12 ml of blood will be assembled from the veins of antecubital fossa~        2. PRP preparation will be done according to Mostafa et al., 2013~        3. 0.5 ml of PRP will be injected per 1 cm2 of ulcerated mucosa~      The second group will receive triamcinolone acetonide 40 mg injected 1 ml per 1 cm2 of~     ulcerated mucosa~      Both groups will receive a total of 4 injection, the injections will be carried out once a~     week.~      Pain, lesions size and remission time are the outcomes will be assessed using a numerical~     rating scale (Seymour, 1982), clinical score according to Thongprasom et al., 1992 and binary~     scale for remission time according to Conrotto et al., 2006, respectively.~      Assessment of the outcomes will be carried before the trial (baseline records) and before~     receiving the treatment in each visit by the primary investigator (H.A.) and the blinded~     assessor (Dr. A.W.) separately.~      Each participant will have a total of 11 visits during the trial, 5 visits will be once every~     week during the trial and every 2 weeks for 3 months treatment free.~   "
20906|NCT03293355|"~     There is an urgent need for treatment service integration for People Living with HIV (PLH)~     because many PLH have comorbid conditions, including substance use disorders and psychiatric~     disorders, among others. Although providing integrated services to PLH who use drugs (PLHWUD)~     has been proven to produce positive outcomes, multilevel challenges must be addressed,~     including barriers at the policy, structural, and provider levels. Many countries, including~     Vietnam, face challenges in the pursuit of multilevel integration of combination treatment~     services and care. In Vietnam, injecting drug use accounts for nearly two-thirds of HIV~     infection, and methadone maintenance therapy (MMT) services have rapidly expanded to 135~     clinics with over 25,000 clients since 2008. There is a timely call as well as an opportunity~     to identify, implement and evaluate new strategies to provide MMT and HIV treatment as an~     integrated service system for PLHWUD. The study will take advantage of this window of~     opportunity to explore and pilot integration strategies to address the multilevel challenges~     associated with service integration in Vietnam.~   "
20907|NCT03293342|"~     The study is an RCT study comparing a 3-5 intervention treatment with dentist administered~     Cognitive Behavioural Therapy ( D-CBT) with a control treatment. The control treatment is a~     treatment as usual concept using premedication with benzodiazepines and a common sense~     approach.~      The treatment will be performed in a regular dental office. The dentist is working as a~     regular dentist and is trained in the CBT Method.~   "
20908|NCT03293329|"~     A randomised and controlled trial to people diagnosed with rotator cuff injuries who are~     divided into 3 groups of treatment: shoulder myofascial trigger points release, manual~     diaphragm release and diaphragm mobilization through hipopressive gymnastic exercise. The~     pain and range of shoulder movement are assessed before and after the treatment in all the~     participants.~      Hypothesis of the clinical study: the treatment of diaphragm muscle, via manual release or~     active mobilization, has impact on rotator cuff injury symptoms comparing with a standard~     treatment of shoulder myofascial trigger points release.~      Discussion: The relation between shoulder and diaphragm muscle, through innervation (phrenic~     nerve and brachial plexus), embryology and myofascial connections, could lead to include in~     clinical practice the examination and treatment of other structures besides shoulder girdle~     such as diaphragmatic region in rotator cuff injuries.~   "
20909|NCT03293316|"~     Inter-individual variability in responsiveness to interventions poses great challenges for~     translational neuroscience, and health care in general. The investigations sought to examine~     the potential for high-frequency transcranial random noise stimulation (tRNS) to modulate~     sustained attention in a manner that was informed by individual differences in EEG indices.~   "
20910|NCT03293303|"~     BACKGROUND: Older adults spend approximately 80% of their awake time in sedentary activities~     which represents 8 to 12 hours per day. In the past, numerous stand-alone exercise programs~     have been developed. However, it is challenging to persuade older adults to become and~     maintain physically active. Consequently, physical activity should be embedded in the daily~     life of older adults to reduce their sedentary time, prevent negative health consequences and~     facilitate ageing in place.~      INTERVENTION: 'Stay Active at Home' is not an additional, (classical) exercise programme;~     physical activity is integrated in usual home care. Healthcare professionals learn to engage~     older adults in daily life in order to improve their physical activity and reduce their~     sedentary time. For example, washing the upper body and face independently; changing the~     pillowcase, while professional changes bedcover; and motivating clients to join a dancing~     class at the community centre.~      AIM and DESIGN: The aim of this cluster randomised controlled trial is to provide evidence~     about the (cost-) effectiveness of 'Stay Active at Home' prior to dissemination and~     implementation of the programme. Alongside the trial an extensive process evaluation will be~     conducted.~   "
20911|NCT03293290|"~     This study has two components. The first component is designed to assess and compare the~     awareness, attitudes and clinical eligibility of Pre-exposure Prophylaxis (PrEP) in criminal~     justice (CJ) involved women. The second component is designed to evaluate the acceptability~     and feasibility of strategically delivering PrEP to CJ involved women and their risk network~     members.~   "
20912|NCT03293277|"~     The aim of this study is to investigate the safety, pharmacokinetics, pharmacodynamics of~     intranasal dexmedetomidine, and comparative pharmacokinetics of intranasally and~     intravenously administered dexmedetomidine in healthy volunteers.~   "
20913|NCT03293264|"~     Hypothesis: An occupational 6 months physical exercise training will lead to better health~     behaviour and improve the severity of the metabolic syndrome.~      300 subjects will be assigned to either an intervention or a waiting-control-group. The~     intervention group will receive instructions with the aim to perform 150 min exercise~     training per week. Exercise consists of endurance, strength and coordination training. A~     feedback system guided by sports scientists will be installed for all subjects in the~     intervention group using activity monitoring (wearable). After 6 months training subjects~     from the intervention group will be assigned to one of the following groups for follow-up~     observation from month 6 to months 12:~        -  training with personal/individual feedback from sport scientist~        -  training with automated feedback using activity monitoring Tools (wearable)~        -  training without further feedback Subjects assigned to the control group will be~          provided with information on low intensity motion exercises. After 6 months in the~          control group subjects will be provided with the same exercise intervention as the~          intervention for a duration of 6 months.~      Study visits will be conducted at month 0, month 6 and month 12.~   "
20914|NCT03293251|"~     1. determine whether cataract surgery has a major effect on outcomes of trabeculectomy with~          MMC or not.~        2. Success rates of trabeculectomy with MMC in Queen Elizabeth hospital.~        3. recurrence rate of uveitis after glaucoma surgery~   "
20915|NCT03293238|"~     This study will compare the accuracy and patient reported outcomes between four different~     techniques used to perform a knee injection.~   "
20916|NCT03293225|"~     A randomized open labeled trial to compare the efficacy of antihistamine dosing-up and add-on~     treatment with H2-receptor antagonist in patients with chronic urticaria~   "
20917|NCT03293212|"~     The objective of this study is to assess and analyze the characteristics and usage of~     conventional and Korean medical services in postoperative patients. This study therefore~     investigates the proportion of patients with a history of surgery out of patients visiting a~     spine-specialty Korean medicine hospital, and the prognosis and preference for conventional~     and Korean medicine treatment by previous treatment history in postoperative patients.~   "
20918|NCT03293199|"~     Spontaneous pneumothorax is a common condition which is defined as air presence inside of~     pleural space. Despite, several studies that have been carried on management patients~     suffering spontaneous pneumothorax, the first step approach on patients is still the topic of~     debate. Since chest tube drainage and needle aspiration are widely used first step techniques~     in spontaneous pneumothorax, current study compares the efficacy of abovementioned~     techniques, as well as long-term outcomes. In current multi-center single-blinded RCT, all~     patients admitted with spontaneous pneumothorax will be enrolled study and written consent~     form provided by patients, simultaneously. Patients randomly assigned to study groups~     including (A) chest tube drainage and (B) needle aspiration. Subsequently, all patients will~     undergo one-year follow-up and will be evaluated in terms of treatment success rate and~     pneumothorax recurrence. Hypothesis of present trial are as follows: a) repetitive needle~     aspiration may lead to higher treatment success rate in patients with primary spontaneous~     pneumothorax, in comparison to chest tube drainage, b) needle aspiration may result in~     reduction of hospital admission duration in patients with primary spontaneous pneumothorax~     compared to chest tube drainage, c) the rate of spontaneous pneumothorax recurrence during~     one-year follow up might be lower in patients who undergo needle aspiration instead of chest~     tube drainage.~   "
20919|NCT03293186|"~     One of most important complication of thyroid surgery is adhesion. There are many~     anti-adhesive materials, but none of them showed significant outcomes. The investigators~     planned double blind prospective study of Thermo-sensitive Adhesion Barrier (MEDICLORE) to~     reveal anti-adhesive effect of MEDICLORE. The investigators will recruit total 90 patients~     (control group 45, experimental group 45) and compare postoperative outcomes about adhesion.~   "
20920|NCT03293173|"~     This study is testing whether stratification of the patients according to biological risk~     factors for different treatment groups will improve the outcome of patients with clinically~     high diffuse large B-cell lymphoma (DLBCL).~   "
20921|NCT03293160|"~     This study will examine the effects of a care management program on the health and health~     spending outcomes of patients residing in Michigan's Washtenaw and Livingston Counties.~   "
20922|NCT03293147|"~     Non-adherence to antihypertensive treatment is one of the leading causes of suboptimal blood~     pressure control and translates into increased risk of cardiovascular morbidity and~     mortality. Currently, there is no effective intervention for therapeutic non-adherence. Our~     project will assess whether high performance liquid chromatography mass spectrometry~     (HPLC-MS/MS)-guided intervention (providing patients with information on the results of their~     HPLC-MS/MS-based urine analysis combined with targeting the main reason for non-adherence)~     leads to an improvement in blood pressure control, adherence and a reduction in healthcare~     costs. Our multicentre prospective randomised controlled trial consists of 6 stages~     (screening, recruitment, baseline phenotype assessment, intervention, short-term and~     long-term outcome visits). The study will fill in an important gap in knowledge on management~     of blood pressure in non-adherent hypertensive patients beyond the initial diagnostic step.~     It will also inform the development of a cost-effective model for the management of~     non-adherence in chronic disorders that require long-term drug therapy.~   "
20923|NCT03293134|"~     As principal objective, the study aims to:~        1. Describe the spectrum and evaluate the frequency of angiodysplasia of the nevrax;~        2. Establish the physiopathological basis of Fowler's syndrome;~        3. Identify FLVCR2 partners and the signaling pathways involved;~        4. Test new candidate genes: GPR124 and possible partners of FLVCR2.~      As second objective, the study aims to:~        -  perform phenotype / genotype correlation if necessary;~        -  and propose a prenatal diagnosis in families with identified mutations.~   "
20924|NCT03293121|"~     The investigators hypothesize that new runners participating in an 8 week strength and~     coordination training program prior to beginning to run will 1) display different~     coordination patterns , and 2) experience fewer injuries, compared to new runners who do not~     perform strength or coordination training prior to running.~   "
20925|NCT03293108|"~     The purpose of this study is to compare the efficacy and safety of Denosumab 60 mg produced~     by AryoGen Pharmed and Amgen Denosumab 60 mg among osteoporotic postmenopausal women.~     Postmenopausal women diagnosed with osteoporosis according to their Bone mineral density~     result (BMD), aged between 45 to 75 are included in this trial. This is a Phase III,~     randomized, two armed, double-blind, parallel, active-controlled,non-inferiority clinical~     trial. The eligible patients are randomized in a 1:1 ratio to receive Dyenix or Prolia®~     subcutaneous injections, at the beginning of the trial and every 6 months at month 6 and 12,~     in an 18-month study period. Along with, all women will receive daily supplements containing~     at least 1000 mg of elemental calcium (divided into two doses) and at least 400 IU vitamin D~     daily during 18 months of the study.~      The primary objective of this study is to assess non-inferiority of test- Denosumab 60 mg~     (Dyenix) to the reference Denosumab 60 mg (Prolia®) in terms of efficacy among osteoporotic~     postmenopausal women.~      The secondary objectives of this study are:~      To further compare efficacy of test- Denosumab 60 mg to reference Denosumab 60 mg; To assess~     the safety of test- Denosumab 60 mg compared to reference Denosumab 60 mg.~   "
20926|NCT03293095|"~     The aim of this project is to create references values to patients with musculoskeletal~     pathology using functional tasks and measuring with a smartphone and video imaging (3D motion~     capture cameras).~   "
20927|NCT03293082|"~     The objectives of this clinical study is to evaluate the efficacy continuous glucose~     monitoring (CGM) use on glucose variability (GV) in preschool children with T1D treated with~     CSII.~      Downloads from CGM and CSII saved in pdf from will be retrospectively reviewed and analysed~     for all preschool children with type 1 diabetes in Slovenia. Glucose variability and other~     glycemic parameters will be analyzed separately for periods when CGM was used (CGM and SMBG~     data) and compared to periods when CGM was not used (SMBG only data).~   "
20943|NCT03292874|"~     This high resolution MRI (hrMRI), along with stand MRI (sMRI) will be obtained at baseline~     and again in approximately 1 year in patients on prostate cancer active surveillance. Changes~     in lesion size and ADC values will be assessed on the serial studies. This study evaluates~     the hypothesis that hrMRI will detect changes that sMRI cannot detect and that these changes~     will correlate with prostate cancer progression as determined on prostate biopsy.~   "
35421|NCT03102957|"~     Exploring the reorganization (plasticity) of neuroanatomic networks associated with language~     and memory in patients with left (or dominant hemisphere) temporal lobe epilepsy using~     functional MRI (fMRI)~   "
20928|NCT03293069|"~     The alteration of iron metabolism is reported in animal models of amyotrophic lateral~     sclerosis (ALS) as well as in sporadic and genetic forms (SOD1 and C9orf72) of ALS. The high~     iron concentration of the brain, due to its high energy demand (high oxygen consumption),~     makes motor neurons particularly vulnerable to energy deficit and oxidative stress.~     Post-mortem examinations and MRI scans in patients with ALS have found signs of iron~     accumulation in the central motor tract; and a high level of serum ferritin, which is a~     marker of iron levels, is associated with a lower prognosis. In ALS mouse models, the use of~     iron chelators has demonstrated neuroprotection and increased life expectancy, suggesting~     that elimination of excess iron from the brain can prevent neuronal loss and, consequently, a~     slow progression of the disease. Conservative chelation of iron refers to a modality whereby~     much of the iron that binds to the chelator is redistributed in the body rather than~     exhausted. Using a chelator, deferiprone, with this feature, in a safety pilot study, a very~     good safety profile was observed. Deferiprone eliminated excess iron from brain regions,~     reduced oxidative damage and cell death associated with regional iron deposits with no~     apparent negative impact on the iron levels needed. Now, the efficacy of this new therapeutic~     modality of neuroprotection is being evaluated in a randomized, double-blind,~     placebo-controlled, multicenter study.~   "
20929|NCT03293056|"~     Introduction: water aerobics involves the practice of specific aquatic exercises that are~     based on the use of water resistance as a load and on thrust as an impact reducer, making it~     possible to perform physical exercise with a lower risk of injury even at a high intensity.~     Objective: The overall objective of this study will be to compare the effectiveness of high~     intensity interval versus moderate continuous water aerobics to improve health outcomes in~     apparently healthy individuals.~   "
20930|NCT03293043|"~     This project is focused on helping one of the most vulnerable patient populations in~     medicine, patients with end-stage chronic lung disease. Lung transplantation is the only cure~     for end-stage lung disease, however, due to the persistent shortage of donor organs, either~     due to low organ donation rates or unacceptable organs, only a minority of patients receive~     desperately needed lung transplants. Currently less than 30% of potential donated thoracic~     organs are being used for transplantation. The major causes for under utilization of donor~     thoracic organs are injury sustained by the lungs in trauma or emergency resuscitation or~     lungs that come from donors who are pronounced dead due to cardiac arrest (known as DCD~     donors). It has been hypothesized that these injuries may be reversible or repairable if~     there was an opportunity to evaluate and repair these organs outside of the body (ex-vivo),~     prior to transplantation. In fact, studies have shown that the use of normothermic Ex-Vivo~     Lung Perfusion (EVLP) has increased the rate of donor organ utilization at centers that have~     adopted the technology.~      Current methodology for all clinically available EVLP devices uses Positive Pressure~     Ventilation (PPV). Researchers at the University of Alberta (UofA), however, have developed~     an EVLP device that will apply Negative Pressure Ventilation (NPV) to the lungs, as opposed~     to PPV, which is the most ideal mimicry of native lung physiology. The objective of this~     early feasibility safety trial is to show that the UofA developed NPV-EVLP device is~     acceptable in evaluating and improving the quality of marginal donor lungs compared to~     currently used EVLP devices, ultimately allowing for these types of donor lungs to be safely~     transplanted into patients on the lung transplant recipient waitlist.~   "
20931|NCT03293030|"~     This is a single-arm, open-label study, which will examine the effect of dupilumab on the~     immunologic and genetic environment within atopic dermatitis lesions.~   "
20932|NCT03293017|"~     The study goal is to investigate whether administration of oral baclofen forms an adequate~     treatment option in the management of acute alcohol withdrawal. The investigators will~     compare placebo with doses of baclofen 30 and 60 milligram per day (mg/day) in a randomized~     controlled trial including patients receiving symptom triggered diazepam.~   "
20933|NCT03293004|"~     Previous work has shown that gelatin supplementation could increase collagen synthesis in~     humans. In this study subjects consume placebo, 5 or 15 g of gelatin with a standard amount~     of vitamin C (48 mg) 1 hour before 6 minutes of jump rope exercise. The feeding and exercise~     intervention was repeated every 6 hours while the subjects were awake for three days and the~     amount of the amino terminal procollagen I peptide (PINP) was determined; a marker of~     collagen synthesis, in the blood. Consistent with the hypothesis that gelatin increases~     collagen synthesis in humans; the amount of PINP in the 15 g gelatin group was significantly~     higher than either the placebo or the 5 g groups. These data conclusively demonstrate that~     gelatin supplementation can increase exercise-induced collagen synthesis in humans.~     Hydrolyzed collagen has a similar amino acid profile, in particular with high concentrations~     of glycine, proline, hydroxyproline, and arginine. Thus the current study aims to precisely~     map out the dose response relationship of hydrolyzed collagen and vitamin C on PINP and to~     determine the optimal dose to achieve maximal increased in PINP levels.~   "
20934|NCT03292991|"~     All study objectives will be assessed in HCC patients or colorectal cancer patients with~     secondary metastases in the liver, respectively.~   "
20935|NCT03292978|"~     The aim of the study is to examine the effects of probiotics intervention on choline~     metabolites and intestinal microbiota composition using a randomized double blind clinical~     trial. Also, we proposed to explore the real-time change of choline metabolites after~     probiotics intervention through a PC challenge test. Our study will clarify the biochemical~     pathway involved in metabolic diseases and hope to provide a new targeted-preventive and~     therapeutic strategy for chronic metabolic diseases.~   "
20936|NCT03292965|"~     Compare the reversal effect of neostigmine and sugammadex using quantitative neuromuscular~     monitoring~   "
20937|NCT03292952|"~     The study is a multicenter, dose-optimized, double-blind, randomized, placebo-controlled,~     parallel efficacy laboratory classroom study with KP415 in children with~     Attention-Deficit/Hyperactivity Disorder (ADHD).~   "
20938|NCT03292939|"~     The aim of our study is to assess the effect of vaginal progestrone on fetal and maternal~     doppler indices~   "
20939|NCT03292926|"~     A comparison of two anesthetic techniques-- the Adductor Canal Block (ACB) and the Adductor~     Canal Block with Infiltration of the interspace between the popliteal artery and the capsule~     of the posterior knee (ACB/IPACK)-- in patients undergoing bone-tendon-bone (BTB) anterior~     cruciate ligament (ACL) reconstruction.~   "
20944|NCT03292861|"~     This is a randomized, controlled, single center study to evaluate the efficacy of~     Thymoglobulin induction therapy in combination with Mycophenolate Mofetil, tacrolimus, and~     steroids in the prevention of CAV. Approximately half of the patients will be randomized to~     receive a total of 5 doses of Thymoglobulin during the study. The first dose of Thymoglobulin~     will be administered at 1.5 mg/kg via intravenous infusion over 6 hours immediately upon~     arrival to the ICU post-operation (day 1). Subsequent doses of 1.5 mg/kg will be administered~     on days 2, 3, 4, and 5 via IV infusion over 4 hours.~      Mechanistic assays (T-reg cells, Lym subsets, B cell subsets, IL-1b, cytokines, TGFb, IL-21~     to be drawn at Pre-transplant, 3, 6, 12 months post-transplant) will also be performed.~      All patients will be followed and monitored according to standard of care protocols for heart~     transplant recipients at our center.~   "
20945|NCT03292848|"~     A study to assess pharmacokinetics, safety and tolerability of brexpiprazole in children ages~     6 to <13 years with CNS disorders.~   "
20946|NCT03292835|"~     This study evaluates the effect of clean wound management and dressing on complex zoonotic~     cutaneous leishmaniasis caused by L. major in the MENA region (Algeria). The patients will~     participate in the wound dressing themselves. The objective is to determine the amount of~     patients that can avoid systemic chemotherapy with pentavalent antimony which is compulsory~     for patients with complex CL lesions. In Algeria, this requires expensive hospital care~     because of the eventual toxic side effects of Sb(V).~   "
20947|NCT03292822|"~     Oral squamous cell carcinoma (OSCC) are considered as a one of the most malignant cancers. It~     has prognosis due to its distant metastasis and obvious destruction which lead to low~     survival rate.~      The conventional treatment modalities such as surgery, radiotherapy and chemotherapy are only~     the suitable strategies until now. Investigators cannot ignore the serious side effects of~     chemotherapy such as gastrointestinal upset, bone marrow suppression which cannot be~     overcome. For all these complications, there is a great need and demand to discover a new~     agents and strategies for treating OSCC.~      Licorice extract, especially Licochalcone A, is one of many natural extracts that have used~     as a traditional in treatment of inflammation, microbial infections. Regarding antitumor~     effect, Licochalcone A reveals interesting results in programmed cell death and apoptosis in~     cancer cells such as prostate, bladder, colon and gastric cancer.~   "
20948|NCT03292809|"~     The objective of this study is to assess the efficacy, safety, and tolerability of CyclASol~     Ophthalmic Solution in comparison to vehicle for the treatment of the signs and symptoms of~     DED.~   "
20949|NCT03292796|"~     Post-operative cystoid macular oedema (CMO) is a common complication causing visual loss~     following routine cataract surgery. This complication is more prevalent in eyes with~     excessive inflammation as they heal from surgery.~      Prostaglandin analogues (PGA) are the commonest first line drugs used in the long-term~     treatment of primary open angle glaucoma (POAG)- where they reduce the pathologically high~     pressure in the eye. Prostaglandins are inflammatory mediators.~      In the post-operative care of glaucoma patients undergoing cataract surgery, there is a~     clinical dilemma whether to stop or continue the use of prostaglandin eye drops. Clinical~     practice is completely dichotomized between continuing and stopping PGA treatment in the~     postoperative period. There is conflicting scientific literature on the effect of PGA on the~     incidence of CMO; and only a single randomized control trial (Miyake K, Arch Ophthalmol 1999,~     117:34-40), where the post operative regime is not applicable to present practice, compared~     the incidence of CMO following routine cataract surgery in POAG on PGA.~   "
20950|NCT03292783|"~     The purpose of this open-label, dose escalation-dose expansion, Phase 1 clinical trial is to~     evaluate the safety, pharmacokinetics and anti-tumor activity and determine the maximum~     tolerated dose (MTD) and recommended phase II dose (RP2D) of NOV1501 (ABL001).~   "
20951|NCT03292770|"~     Despite these revolutionary changes in the laboratory, little has changed with the process of~     embryo transfer (ET). A study to prospectively evaluate the role of cervical mucus removal~     prior to embryo transfer on pregnancy rates in ART will be undertaken.~   "
20952|NCT03292757|"~     This is a non-randomised study assessing the technique of using indocyanine green as a~     fluorescent dye to highlight the thoracic duct during oesophectomy.~   "
20953|NCT03292744|"~     Vitamin D has been known to influence immune response through Vitamin D Receptor in Immune~     Cells, but only few has been known about the effect alfacalcidol, a vitamin D analog to~     immune system. In elderly, immune disregulation or immunosenecence have great impact to~     infection response. This study is aimed to determine the effect of alfacalcidol~     supplementation in vitro and in vivo to respiratory infection incidence and inflammatory~     markers, as well as T cell lymphocyte subset in Indonesian elderly patients.~   "
20954|NCT03292731|"~     The study plans to determine the relationship between plasma concentrations of 17-OHPC~     (hydroxyprogesterone caproate) and the rate of preterm birth. The study is a randomized, open~     label study of pregnant women with one or more prior spontaneous preterm births. Subjects are~     randomized to a weekly single injection of either 250 or 500mg 17-OHPC (hydroxyprogesterone~     caproate).~   "
20955|NCT03292718|"~     Interventional trial to study the influence of the use of MyCyFAPP (mobile application) on~     the gastro-intestinal related quality of life.~      This mobile APP has been developed during previous workpackages of the Horizon2020 Project~     and contains several modules:~        -  mathematical prediction model to calculate the needed dose for pancreatic enzyme~          replacement therapy~        -  educational games and other educational material~        -  communication with doctor/dietician through professional webtool~        -  diary to register symptoms and data on nutrition.~      The app will be introduced and used during 6 months. Primary outcome parameter will be change~     in modified PedsQL GI after 3 months. PedsQL GI is an existing questionnaire that evaluates~     gastro-intestinal related quality of life in children. We validated it for use in cystic~     fibrosis in a previous observational study.~   "
20963|NCT03292614|"~     This Study determines the most precise method for measuring post-operative refraction~     following implantation of the asymmetric multifocal LS-313 MF30 comparing the results of~     Refraction of the different Autorefractor Keratometers with the subjective measurements for~     distance and near.~   "
21232|NCT03289117|"~     A randomized, open label, controlled, parallel group study to investigate difference between~     regional standard procedure and a novel modified procedure (using an additional novel device~     to facilitate gel installation) for changing long-term indwelling urinary catheters.~   "
20956|NCT03292705|"~     Computerized cognitive interventions (CCIs) have been increasingly widely implemented among~     older adults with mild cognitive impairment (MCI). However, the efficacy of CCIs in~     maintaining or improving older adults' cognitive and functional health has been modest and~     highly variable. Older individuals' attitudes toward technology use may help explain some of~     the variability in CCI effects. The goal of this R21 is to generate proof-of-concept for an~     intervention that may improve attitudes toward computers among those with MCI, in turn~     improving engagement with and efficacy of a subsequent CCI. Person-centered care—that is,~     integrating individuals' preferences throughout the process of intervention--has improved~     intervention engagement among older persons, including those with MCI. A recent intervention~     predicated on this person-centered approach is called personalized engagement program~     (PEP). PEP involves a database of individualized computer-led leisure activities. The~     investigators' recent pilot data in senior living facilities suggest that PEP promotes~     psychological well-being among older persons with MCI, and may shift computers from~     dauntingly complex or personally irrelevant devices to familiar, enjoyable technology. These~     results are consistent with a number of theories indicating that exposure to pleasurable~     experiences with an object or task improves several dimensions of attitudes, including~     affective and cognitive components, as well as behavior and motivation. Grounded in both this~     pilot data and the theory around it, the investigators seek to take the next step in an arc~     of research ultimately intended to improve the efficacy of CCIs. A small randomized~     controlled trial (RCT) is proposed to assess whether an initial period of PEP, followed by a~     standard CCI, improves a) attitudes toward computers, b) engagement with the CCI, and c)~     cognitive outcomes, compared to an attention control period followed by CCI. Our design~     involving stratified random assignment of 50 assisted living residents with MCI from 4 senior~     living facilities to these two groups. The initial phase involves 4 weeks of either attention~     control or PEP, a dose suggested by prior work on attitude change and computers, followed~     by 6 weeks of CCI for both groups (a period our prior work indicates is sufficient for change~     in key cognitive domains among this population). This application is the first of which we~     are aware striving to augment CCIs, which are now ubiquitous, by addressing an attitudinal or~     affective element of the person, which are often ignored in the cognitive intervention~     literature. The adjuvant of PEP also answers increasing calls for personalized or~     person-centered behavioral interventions with older persons.~   "
20957|NCT03292692|"~     Although several empirically-supported interventions to prevent and treat relationship~     distress have been developed, the majority of couples - especially high-risk couples - do not~     seek these face-to-face interventions. However, our pilot data indicate that large numbers of~     couples will seek self-administered assistance for their relationship. Additionally, unlike~     many in-person interventions, couples seeking self-help resources tend to have higher levels~     of relationship distress. Thus, to improve the reach of couple interventions, this project~     will translate a leading empirically-supported intervention targeting early signs of~     relationship distress into a Web-based format. This intervention will consist of~     individualized feedback and professionally-filmed video clips tailored to a couple's specific~     needs. By intervening effectively with a large number of couples, the resulting Web-based~     intervention has the potential to have a population-level impact on relationship distress,~     divorce, and resulting child difficulties.~      In the proposed project, building off our previous pilot studies, effective translation of~     this in-person intervention into a Web-based format will be ensured by conducting two~     additional intensive pilot studies. Once final changes have been made to the website and~     Web-based intervention, 300 couples will be randomly assigned to a wait-list control group or~     an online intervention. All couples will be assessed for the initial two months; intervention~     couples will be assessed for one year. This project will: 1) demonstrate that couples~     randomly assigned to the online intervention will report higher levels of individual, child,~     and relationship functioning than those in the wait-list control group; 2) document the~     mechanisms of both active conditions; and 3) show that initial gains in those assigned to the~     intervention are largely maintained through one-year follow-up.~   "
20958|NCT03292679|"~     3D printing is a technology that allows for physical creation of a 3D model (usually made of~     plastic) based on computer generated 3D images from CT scans. The 3D images of craniofacial~     skeleton using computer software are routinely generated and, in turn, these 3D images can be~     used to create a plastic 3D model using a 3D printer.~      Unstable or comminuted facial fractures need to be reduced and rigidly fixated using titanium~     plates and screws. Bending and shaping of the plates is usually performed by free-hand based~     on the surgeon's estimation of what best fits the fracture.~      Often, bending the titanium plates to the shape of pre-injury skeletal contour is difficult~     when the bone is fractured into many pieces or is unstable, or when the patient is edentulous~     (missing several teeth). The process can increase the time spent in surgery and the bent~     plates may not snugly fit the fracture. For these difficult cases, one option is to use~     commercially manufactured 3D printed patient-specific models. The patient-specific models~     provide the benefit of correct shape / form for increased surgical accuracy, and decreased~     intra-operative time. However these commercial models are manufactured at distant facilities~     and usually require more than 7 days before delivery. As such, they delay time to surgery and~     cannot be used for urgent surgery. Additionally, the commercially manufactured implants are~     expensive, significantly increasing the cost of treatment.~      The purpose of this study is to explore whether custom plastic models 3D printed at Shock~     Trauma Center and used for bending and shaping plates for facial fracture repair can improve~     results of facial fracture reconstruction.~      Our plastic surgery division will design and produce facial bone 3D model of patients (with~     facial fractures) using an in-house 3D printer, then use the 3D model to contour the hardware~     pre-op or intra-op at the time of fracture repair. We believe that we can achieve better~     repair, shorter surgery time, and save hardware cost.~   "
20959|NCT03292666|"~     The proposed research seeks to provide insights on the contemporary epidemiology, treatment,~     and outcomes of VTE, including examining the uptake of new treatment strategies, the efficacy~     and safety of different anticoagulant options, and the impact of venous thromboembolism on~     patient-defined outcomes, such as quality-of-life, symptom burden, and treatment~     satisfaction. This information is crucial to helping clinicians and patients choose between~     various treatment options for venous thromboembolism in order to achieve the best possible~     balance between the risks, benefits, and impact on health.~   "
20960|NCT03292653|"~     Primary Objectives:~        -  Assess the safety and tolerability of sotagliflozin in hemodynamically stable patients~          with worsening of heart failure, compared to placebo.~        -  Estimate the effects of sotagliflozin on plasma volume changes in hemodynamically stable~          patients with worsening of heart failure, compared to placebo.~      Secondary Objectives:~        -  Explore the effect of sotagliflozin on erythropoiesis, as assessed by changes in plasma~          erythropoietin levels, in hemodynamically stable patients with worsening of heart~          failure, compared to placebo.~        -  Explore the effect of sotagliflozin on changes in plasma NT-proBNP levels, in~          hemodynamically stable patients with worsening of heart failure, compared to placebo.~   "
20961|NCT03292640|"~     Enrollment of subjects with mild to moderate facial acne vulgaris. Acne lesions of any~     severity on the chest and/or back (including shoulders) may be enrolled provided they have~     mild to moderate acne on the face. During the 12-week treatment period subjects will use the~     study product twice daily with approximately 12 hours between applications. Subjects will be~     instructed to treat the entire face (and chest/back including shoulders, if applicable).~      Co-Primary efficacy endpoints include:~        -  Absolute change from Baseline to Week 12 in the inflammatory lesion counts on the face~        -  Absolute change from Baseline to Week 12 in the non-inflammatory lesion counts on the~          face~        -  Proportion of subjects with a clinical response of success at Week 12 for lesions on~          the face. Success based on IGA is defined as an IGA score of 0 (Clear) or 1 (Almost~          clear) at Week 12 with at least a 2-grade reduction from Baseline.~      The primary safety endpoint will be treatment-emergent adverse events (TEAEs). Other safety~     variables include local cutaneous tolerance evaluation (dryness, non-lesional erythema,~     peeling, stinging, burning, and itching) and vital signs (blood pressure and pulse rate).~     Urine pregnancy tests will be performed at Baseline and at every visit through Week 12 for~     all female subjects. A physical examination will be performed at the Baseline Visit.~   "
20962|NCT03292627|"~     Investigators include the patients who need painless invasive endoscopic procedure,~     investigators collect the demographic data and apply the non-invasive device ICON on~     participants during the who procedure.~   "
20964|NCT03292601|"~     The overall aim of the study is to utilize a novel device and smartphone application in order~     to improve measurement of patient compliance with at-home bracing for scoliosis as well as~     create a more accurate assessment of brace fit via continuous and objective measures of~     tension. These ground-breaking metrics will provide analyzable data to more accurately~     reflect and predict actual patient compliance as well as allow for further exploration of how~     to increase compliance, and thus, efficacy of bracing; it will additionally allow both~     physicians and patients to have a more reliable measure for brace fit by providing them with~     continuous data of fit via tension, and provide built-in feedback mechanisms to the patient~     to ensure proper tightness of the brace.~      Additionally, the study will investigate whether providing the wearer's own brace-wear~     compliance information directly to the patient and their caregiver(s) via the mobile app will~     further improve rates of compliance as compared to those who do not receive the same feedback~     mechanism.~   "
20965|NCT03292588|"~     The purpose of this study is to see if treatment with a medication called Nucala®~     (mepolizumab), given along with standard asthma care, makes children less likely to have~     asthma attacks.~   "
20966|NCT03292575|"~     Stroke is a major public health problem as it is very frequent (140,000 cases/year in~     France), and very serious (leading cause of death, 2nd leading cause of dementia, 3rd leading~     cause of handicap). Ischemic cardio-embolic stroke accounts for around 25% of ischemic~     strokes, and ischemic cardio-embolic stroke in a context of cardiac arrhythmia due to atrial~     fibrillation (CAAF) is the leading non-atheromatous cause. The aim of this study is to~     optimise the secondary prevention of CAAF-related stroke identified at the University~     Hospital of Dijon Burgundy in the framework of the recommendations of the '2010-2014 stroke~     plan' and the Compulsory Consultation at the 6th month (Directive DGOS//2015/262 of the 3rd~     August 2015)~   "
20967|NCT03292562|"~     The purpose of this study is to determine if among infants <30 weeks gestational age on nasal~     continuous positive airway pressure (NCPAP), whether discontinuing CPAP after gradual~     reduction in continuous positive airway pressure (CPAP) pressure leads to successful weaning~     off CPAP when compared to discontinuing CPAP without weaning pressure.~   "
20968|NCT03292549|"~     The purpose of the study is to set up the larger prospective study on robotic partial~     nephrectomy, to describe the characteristics of patients operated for kidney cancer by this~     surgical procedure and also to determine the modalities of hemostasis in this procedure.~   "
20969|NCT03292536|"~     This is a single arm, open label, pharmacodynamics, intrapatient dose escalation phase 1B~     study.~   "
20970|NCT03292523|"~     Hyperventilation syndrome is associated with impaired quality of life. The aim of the study~     is to assess the relationship between work productivity, including absenteeism and~     presenteeism, and the severity of hyperventilation syndrome~   "
20971|NCT03292510|"~     Community walking is an issue that older adults with chronic conditions have described as~     important to participation in the community. Walking outside the home is a universally~     accessible form of physical activity that has multiple health benefits. Walking for 150~     minutes per week can help reduce the risk of cardiovascular disease, hypertension, stroke,~     diabetes, osteoporosis, and depression, as well as falls. Practice walking across roads,~     slopes and curbs, while talking, and dealing with crowds and traffic, is safe and feasible~     and can improve confidence, balance and walking ability. Being physically active outdoors in~     nature appears to improve mental health more than being active indoors. Despite these health~     benefits, the majority of older Canadians do not walk outside on a regular basis. Barriers to~     walking outside include fear, physical disability due to chronic disease, the appropriateness~     of footwear and walking aids, and the physical environment, such as uneven pavement, weather~     and temperature. To date, the best strategy for getting people to walk outdoors regularly is~     unknown. The investigators propose to evaluate the effectiveness of a dynamic 1-day workshop,~     at which older adults who infrequently walk outdoors learn strategies to facilitate outdoor~     walking, such as appropriate use of footwear, ambulatory aids and equipment, goal setting,~     and practice skills related to increasing outdoor walking. The workshop will be compared to~     the workshop plus involvement in a walking group for 3 months. Outcomes include outdoor~     walking activity, total physical activity, walking ability, participation, and health-related~     quality of life. Each participant will have three evaluations: before the intervention and 3~     and 6 months later. The investigators will interview select participants at 6 months to ask~     them about their opinions of what worked and didn't work. Increasing outdoor walking is~     expected to improve health and well-being, and help people live independently in the~     community for longer.~   "
20972|NCT03292497|"~     Ischemic mitral regurgitation is a disease where the mitral valve is regurgitant, or leaking,~     as a result of changes in the muscle of the heart caused by coronary artery disease Ischemic~     mitral regurgitation, or IMR, is normally treated by repairing or replacing the mitral valve.~     Currently, we don't have very strong evidence showing which patients might benefit from~     mitral valve repair and which might benefit from replacement, and surgeons tend to repair or~     replace valves based on their preference or experience. Some surgeons, including Dr. Vincent~     Chan, the Principal Investigator, believe that the decision to repair or replace the valve~     should be based on specific measurements of the mitral valve. This study will randomly assign~     patients to receive either the current standard of care for ischemic mitral regurgitation,~     which is valve repair or replacement based on the surgeon's preference, or to have their~     treatment decided by a set of criteria called an algorithm. This algorithm will assign~     patients with certain mitral valve measurements to repair, and others to replacement.~     Patients will be followed for 12 months after surgery, to compare whether patients whose~     treatment was decided by the algorithm did better than patients whose treatment was decided~     by surgeon preference.~   "
20973|NCT03292484|"~     The purpose of this study is to assess AR101's safety and tolerability over an extended~     dosing period.~   "
20974|NCT03292471|"~     This study will investigate the use of repetitive transcranial magnetic stimulation (rTMS), a~     non-invasive brain stimulation method, to improve word-finding abilities in Veterans and~     non-Veterans with chronic language problems following stroke (aphasia). Improving~     word-finding is important because word-finding difficulties are among the most common and~     debilitating consequences of aphasia. Although rTMS has shown promise as a treatment~     approach, not all individuals with aphasia show the same level of benefit. Specifically, this~     study will use functional magnetic resonance imaging (fMRI) to examine whether the likelihood~     of improved word-finding abilities following rTMS depends on pre-intervention~     language-related brain activity and will examine changes in brain activity in response to~     stimulation. A better understanding of how and for whom rTMS works will 1) help to identify~     the best candidates for rTMS treatment, 2) optimize rTMS treatment protocols to improve~     patient outcomes, and 3) improve the investigators' understanding of how the brain~     re-organizes language functions following stroke.~   "
21233|NCT03289104|"~     The objective of this study is to determine whether sternal reconstruction using the ZIPFIX~     system compared to standard wire cerclage could improve bone healing, patient function, and~     decreased postoperative pain.~   "
20977|NCT03292432|"~     Youth Living with HIV (YLWH) often face unique challenges achieving high and sustained rates~     of adherence to their antiretroviral therapy (ART). Poor adherence can lead to unsuppressed~     virus, more advanced HIV disease and poorer health outcomes, eventually exhausting treatment~     options. To date however, there are few demonstrated interventions for youth failing first~     line therapy. This study will evaluate a novel intervention that uses remote coaching through~     video enabled counseling sessions, a 'smart' pill bottle that notifies an adherence coach~     when youth fail to open/close the device around dose time, and problem solving outreach by~     the coach when and as needed. This intensive 'boot camp' strategy is implemented for 12 weeks~     followed by observation through 48 weeks.~   "
20978|NCT03292419|"~     The investigators are analyzing outcomes of topography-guided LASIK surgery in participants~     with myopia and myopic astigmatism~   "
20979|NCT03292406|"~     To assess the efficacy, safety and pharmacokinetics in subjects treated with CD11301 gel vs.~     placebo for early stage CTCL (IA, IB, or IIA).~   "
20980|NCT03292393|"~     The study objective is to build group social norms to improve individual adhere to~     antihypertensive medications. Financial incentives are provided to individuals contingent~     upon group behavioral changes. Groups of patients will be formed, and incentivized to~     interact on a daily basis through social media and participate in a monthly-facilitated~     meeting at a local clinic. By forming groups, making individual outcomes transparent, and~     setting financial incentives contingent to group targets, individual decisions are framed~     within emerging social norms.~   "
20981|NCT03292380|"~     A 24-hour Caffeine Intake Recall (CIR-24) was developed to estimate caffeine consumption in~     the previous 24 hours, modeled after the Automated Self-Administered 24-hour Dietary~     Assessment Tool (ASA24), using a brand-specific database of caffeine-containing foods,~     beverages and supplements. The objective of this study was to evaluate the accuracy of the~     CIR-24 compared to caffeine concentration biomarkers in urine and a caffeinated beverage~     intake frequency screener (CBQ) among a young adult population.~      79 young adults ages 18 to 29 years provided 24-hour urine samples and completed the CIR-24~     and CBQ. Excretion rates for caffeine and eight caffeine metabolites were quantified from~     urine samples using high performance liquid chromatography-polarity switching electrospray~     ionization-tandem quadrupole mass spectrometry with stable isotope labeled internal~     standards.~   "
20982|NCT03292367|"~     Left distal transradial approach (ldTRA) can be an attractive alternative route for left~     radial and right radial artery. Recently, Ferdinand Kiemeneij reported the feasibility and~     safety of the use of ldTRA. But, there is few studies focused on this issue. Therefore, the~     purpose of this prospective observational study is to assess the feasibility and safety of~     the ldTRA for CAG and PCI.~   "
20983|NCT03292354|"~     Cardiac computed tomography (CCT) is one of the standard non-invasive imaging techniques~     allowing imaging of the heart and coronary arteries with a high temporal and spatial~     resolution. The high sensitivity and negative predictive value (NPV) of coronary CT~     angiography (CCTA) make it a valuable tool in the assessment of coronary artery disease (CAD)~     in patients with low to intermediate risk for CAD, especially to rule out CAD. This risk~     stratification can be done with help of multiple different risk-calculators (e.g. the updated~     Diamond-Forrester model by Genders et al. 2012). These calculators take different variables~     into account, e.g. advanced age, gender, blood pressure, diabetes mellitus (DM), lipid~     profile and smoking.~      The aim of CCTA is a high diagnostic accuracy, which depends on both optimal intravascular~     enhancement (in Hounsfield Units; minimal 325 HU) and contrast-to-noise ratio (CNR). Optimal~     intravascular enhancement and CNR depend on different factors such as scan technique (e.g.~     tube voltage, tube potential), parameters of the administered contrast material (CM) and~     patient related factors (e.g. cardiac output (CO), body weight (BW)).~      Patients with cardiac diseases often have multiple risk factors for developing contrast~     induced nephropathy (CIN), e.g. diabetes mellitus, advanced age, hypertension and chronic~     kidney disease. Although the relationship between CTA and CIN has recently come to discussion~     (AMACING trial; Nijssen et al. 2017), it is still desirable to minimise the CM volume used in~     these patients. One method to reduce the CM volume is to personalise the injection protocols.~     The personalisation of injection protocols to the individual patient is gaining more~     attention in the field of CT imaging. The goal is to individualise the injection protocols to~     a level, where the patient only receives the minimal amount of CM needed to acquire a~     diagnostic scan, while maintaining a diagnostic image quality. Many techniques are available~     and have been studied, e.g. adjustment of CM volume to scan protocol, CO, lean body weight~     (LBW) and BW.~      However, no data is available on which of these is the most beneficial method for the~     personalisation of CM injection protocols. Therefore, the aim of this study is to assess the~     performance of three different personalized injection protocols (based on CO, LBW and BW) in~     CCTA with regard to image quality in comparison to previously used protocols in our~     department. We hypothesize that the personalized injection protocols will be non-inferior,~     provide a homogenous coronary enhancement (less non-diagnostic scans) in patients, and will~     account for a reduction of CM volume in our department in comparison to the previously used~     protocols.~   "
20984|NCT03292341|"~     Patients diagnosed with T3/T4 laryngeal cancer in general have several treatment options~     available. In order to help these patients in the decision making process, MAASTRO CLINIC~     designed and developed a web-based decision aid tool (Treatmentchoice). The aim of this study~     is twofold: user-testing Treatmentchoice using a systematically development process and~     establish the impact of the Treatmentchoice on the decision making process.~      The study covers 4 chronological activities: 1. assess decisional needs of patients and~     clinicians, 2. testing patients' and clinicians comprehensibility, acceptability and~     usability on the alpha-version of the tool, 3. establish the impact of Treatmentchoice on~     knowledge, decisional conflict and the shared decision making process, as well as the extent~     clinicians involve patients in decision making and 4. development of an implementation and~     dissemination plan for shared decision making which is based on the evaluation of barriers~     and facilitators for the use of patients decision aid tools in clinical practice.~      A mixed method will be used. It comprises structured interviews combined with think aloud and~     questionnaires with stakeholders involved in the whole process (patients, medical doctors,~     nurses, general practitioners, patient organizations, and insurance companies).~   "
20985|NCT03292328|"~     Some types of chemotherapy used to treat breast cancer can cause damage to nerves with~     symptoms like tingling, numbness, muscle weakness, and pain in the hands and feet that can~     last and can affect functioning. The purpose of this study is to find out the effects of yoga~     on reducing symptoms caused by such nerve damage.~   "
21062|NCT03291327|"~     The objective of the study will be to demonstrate the effects of two active lactobacilli~     (A/B) and determine whether there are any changes in plaque accumulation, gingival health,~     immunological and microbial markers compared to a placebo (P) over a 2-week period of~     refraining from normal oral hygiene practice. This is a single centre, randomised,~     double-blind, parallel group study (3-Arm) of healthy subjects aged 18-30 years designed to~     demonstrate the effectiveness of two active lactobacilli using the experimental gingivitis~     Model: A proof of principle study on plaque, gingival status, immunological and microbial~     markers compared to placebo.~   "
20986|NCT03292315|"~     Chronic spinal cord injury (SCI) results in adverse soft tissue body composition changes and~     an extremely sedentary lifestyle. These abrupt changes often lead to a high prevalence of~     cardiometabolic diseases, such as impaired glucose tolerance/diabetes mellitus and~     dyslipidemia, conditions which predispose those with SCI to an increased risk for~     cardiovascular disease compared to the general population. Due to paralysis and wheel chair~     dependence, maintaining an adequate level of physical activity to counteract these~     deleterious metabolic changes presents a unique obstacle because conventional first line~     interventions are lifestyle modifications (e.g., diet and exercise), which may be difficult~     to achieve. Recently, a new medication has been approved by the Food and Drug Administration~     to improve glycemic control in individuals with diabetes mellitus, and it has also been~     investigated as an off-label treatment to induce weight loss. Glucagon-like peptide-1 (GLP-1)~     agonists are a class of drugs designed to mimic the endogenous incretin hormones released~     from the gut in a glucose dependent manner following a meal. The mechanisms of action for~     this drug class of medications include stimulation of glucose-dependent insulin secretion,~     inhibiting glucagon release, slowed gastric emptying, and reduction of postprandial glucose~     excursions following food intake. In addition to improved glycemic control, this class of~     medications also shows promise for its non-glycemic action of facilitating weight loss. The~     method of delivery of the GLP-1's is by self-administered injections once daily or once~     weekly, depending on the severity of the clinical case and therapeutic targets for a specific~     patient.~   "
20987|NCT03292302|"~     Phase 1 Single Ascending Dose Study in Normal Healthy Volunteers~   "
20988|NCT03292289|"~     This study is a prospective, monocentric study whose aim is to assess the quality of life for~     patients who underwent a coloanal continuity reconstruction and to understand the functional~     issues they encounter. This will potentially provide predictive factors identification of bad~     functional outcomes allowing to guide future decisions. Also, it will allow patients to have~     a reinforced follow-up during the year after the reconstruction.~   "
20989|NCT03292276|"~     Two recent randomized clinical trials reported a significant contribute of Amadeo toward the~     recovery of hand motor function in acute stroke patients in association with physiotherapy~     and/or occupational therapy. However, no data are available in patients with chronic stroke,~     and the neurophysiological mechanisms underlying such clinical improvement need to be~     elucidated. Given that robotic devices harness brain plasticity to foster motor function~     recovery, a deeper understanding of the neurophysiological bases of Amadeo training could~     help clinician to realize patient-tailored rehabilitative training based brain plasticity~     knowledge. We planned a pilot randomized-controlled observer trial aimed at evaluating the~     effects of intensive robot-assisted hand therapy compared with intensive occupational therapy~     in chronic phase after stroke. We estimated that 40 patients per group will be required to~     demonstrate a greater effect of Amadeo as compared to occupational therapy, with an effect~     size of 0.5. Twenty chronic stroke patients (at their first-ever stroke) will be enrolled and~     randomized into two groups. The experimental group will be provided with Amadeo training. The~     Control group will be provided with occupational therapy executed by a trained~     physiotherapist.~   "
20990|NCT03292263|"~     This is an open-label, single center trial of Autologous Stem Cell Transplantation (ASCT)~     with nivolumab in multiple myeloma patients to determine the efficacy and safety of ASCT and~     PD1 inhibitor combination.~      For this purpose, 30 multiple myeloma patients, who have received induction therapy and have~     achieved a partial response (PR), stable disease (SD) or progression, and thus have~     unfavorable prognosis, will be treated with nivolumab administered iv at a dose of 100 mg on~     days 3 before and 17 after high-dose melphalan with autologous stem cell transplantation.~   "
20991|NCT03292250|"~     Open, multicenter, single arm, phase II, biomarker driven umbrella trial for head and neck~     squamous cell carcinoma~   "
20992|NCT03292237|"~     Despite the widespread use of nutrition therapy, no large scale randomized controlled trials~     (RCTs) have demonstrated positive outcomes with delivery of nutrition therapy early in~     critical illness, with some showing no effect with delayed nutrition or even harm.~      There are several possible reasons for the lack of observed benefit from RCTs to date;~     interventions have been short in duration (usually 3-10 days after intensive care unit (ICU)~     admission), perhaps applied at the incorrect time in regards to the patients metabolism and~     recovery, do not consider the patients nutrition risk, and have not addressed what happens to~     nutrition intake post ICU in critically ill individuals. This may explain why RCTs to date~     have not observed any positive associations with the delivery of nutrition; our focus to date~     may have been on the wrong stage of illness. A future study is thus urgently needed, which~     addresses the deficiencies in current RCTs by optimizing nutrition delivery for the whole~     hospital stay and collecting meaningful clinical, process and outcome data, which will~     potentially inform a larger trial of a similar nature.~      This initial study aims to determine whether optimization of energy and protein using a~     pre-tested supplemental parenteral nutrition (PN) strategy in the Intensive Care Unit (ICU)~     and an intensive nutrition intervention in the post ICU period will deliver more total energy~     and protein than standard nutrition care during hospital admission in a group of critically~     ill patients with at least one organ system failure.~      It is hypothesized that use of a supplemental PN strategy in ICU and an intensive nutrition~     intervention in the post ICU period will lead to a minimum increase of 15% in daily energy~     delivery for the whole hospital admission compared to standard nutrition care.~      Fifteen percent has been estimated as the minimum acceptable clinical difference between the~     two groups.~   "
20993|NCT03292224|"~     This study aims to :~        1. Diagnosis of Systemic fungal infections in ICU patients.~        2. Detection the most common fungal species in ICU.~        3. Detection of in vitro antifungal sensitivity pattern~   "
20994|NCT03292211|"~     This study aims to examine the outcomes of early mobilization and early intervention within 3~     days after the onset of hemorrhagic stroke in patients admitted to an intensive care unit~     within 48 hours after stroke. The patients after hemorrhagic stroke who undergo early~     intervention only will be compared with those who also receive early mobilization in order to~     determine if the early mobilization intervention results in earlier or more effective~     recovery of postural stability, activities of daily living function, or motor capacity.~      The participants will be randomly assigned to the following two groups: (1) the early~     mobilization (+early rehabilitation) group and (2) the early rehabilitation group.The~     measurement parameters will be collected before the intervention (basic parameters), two~     weeks after the stroke, four weeks after the stroke and three months after the stroke. SPSS~     (version 17.0) will be used to carry out repeated measures analysis of variance (repeated~     ANOVA) to compare the differences between the groups at different time points (including~     basic values and follow-up values). For statistical significance, Bonferroni correction will~     be applied for the post-hoc analysis of the groups.~   "
28357|NCT03195803|"~     This is a non-pharmacological study evaluating the differential effects of a computerized~     cognitive stimulation program according to the existence or not of white matter~     hyperintensities in elderly with mild cognitive impairment.~   "
20995|NCT03292198|"~     Primary Objective~        -  To compare the effectiveness of 2 treatment protocols for patients with breast~          cancer-related subclinical lymphedema identified through bioimpedance spectroscopy,~          L-dex scores~      Secondary Objectives~        -  To determine the necessary duration of intervention to reverse L-dex scores back to a~          normal range in patients with breast cancer-related subclinical lymphedema~        -  To determine the time elapsed post-surgically to the development of subclinical~          lymphedema identified by bioimpedance spectroscopy, L-dex scores~        -  To identify risk factors for the development of subclinical lymphedema in patients with~          breast cancer~        -  To identify factors associated with the progression to clinical lymphedema following~          treatment of subclinical lymphedema as identified by bioimpedance spectroscopy, L-dex~          scores~      Women with breast cancer diagnoses and planned axillary lymph node procedures will receive~     pre-operative screening of arm volume with bioimpedance, which will capture baseline~     measurements. Then, subjects will undergo periodic screenings for the first 3 years following~     surgery. If a significant change in volume compared to baseline is detected with~     bioimpedance, subjects will be randomized to 1 of 2 treatment groups. The outcomes of 2~     treatment protocols will be compared. Additionally, subjects will be screened each week~     during their treatment interventions to determine the necessary quantity of intervention~     before L-dex scores normalize.~   "
20996|NCT03292185|"~     The main purpose of the trial is to compare the bioavailability (extent of drug absorption~     into the circulation) of insulin degludec and liraglutide as part of a combination product~     insulin degludec/liraglutide compared to the corresponding doses of single, separate~     injections of insulin degludec and liraglutide. Participants will receive all three test~     substances. The order of trial administration will be allocated by chance. During the trial~     period, serials of blood samples will be collected from the participants at three dosing~     periods, in order to determine the concentration of insulin degludec and liraglutide. The~     total volume of blood taken throughout the whole trial period will be less than 400 mL.~     Participants will be asked to stay on daytime and overnight in the trial sites on some~     predefined days. For other outpatient days, participants need to attend the trial site as~     required for drug administration or required assessments.~   "
20997|NCT03292172|"~     This is Phase IB, open label, non-randomized study designed to investigate the dose, safety,~     pharmacokinetics and anti-tumor activity of RO6870810 in combination with a fixed dose of~     atezolizumab. The study consists of two groups, Group 1 (Dose Escalation Group) and Group 2~     (Sequential Dose Group).~   "
20998|NCT03292159|"~     This study will evaluate the safety and effectiveness of Respiratory-gated Auricular Vagal~     Afferent Nerve Stimulation (RAVANS) for improving motor recovery after stroke. Subacute~     stroke patients will receive RAVANS or sham stimulation concurrent with arm motor training~     during 10 intervention sessions occurring daily for 30 minutes over 2 weeks. The safety and~     improvements in arm motor function after the intervention will be compared in patients~     receiving RAVANS to those receiving sham stimulation.~   "
20999|NCT03292146|"~     This protocol is a randomized, double-blind, placebo-controlled clinical trial which aims to~     investigate the effect of denosumab on BMD in women with anorexia nervosa. The investigators~     hypothesize that 6 months of denosumab administration will result in an increase in bone~     mineral density, decrease in markers of bone resorption and improvement in bone~     microarchitecture in osteopenic women with anorexia nervosa compared with placebo.~   "
21000|NCT03292133|"~     This research study is studying a combination of drugs as a possible treatment for EGFR~     mutation-positive lung cancer.~      The drugs involved in this study are:~        -  EGF816~        -  Gefitinib~   "
21001|NCT03292120|"~     the investigators will include 120 patients with a diagnosis of septic shock in accordance~     with the definition given by the 2001 expert consensus. Two groups of patients are likely to~     participate in this study: Patient hospitalized in intensive care for a septic shock =~     Primary patient + patient who develops, the waning of his hospitalization in intensive care~     for another reason, a septic shock = Secondary patient. Haemodynamic monitoring by~     transpulmonary thermodilution allow a patient's close monitoring during the initial phase~     supported. The clinical and biological data, demographic and the severity scores are~     collected for each patient during the first three days of stay. To predict the unfavorable~     evolution of the patients, a measure of the SOFA score at the input (J0) and third day (J2)~     is performed. the investigators analyzed mortality at day 28 in patients with increased~     P₍ᵥ₋ₐ₎CO₂ and those with increasing of organ failure. This research will be conducted~     according to good clinical practice. An information will be distributed to patients.~   "
21002|NCT03292107|"~     Study on Management Thrombosis in Greek cancer patients~   "
21003|NCT03292094|"~     The African-PREDICT study aims to (i) generate new knowledge on the early pathophysiology~     accompanying hypertension development in black South Africans; and (ii) to identify early~     novel markers or predictors for the development of hypertension and cardiovascular outcome.~     By employing also in Africa the latest cutting-edge scientific technologies to measure single~     and multiple biomarkers proven to predict hypertension and cardiovascular outcome (such as~     multiplex analyses, proteomics and metabolomics), precision medicine may have the potential~     to lead to novel strategies in preventing and treating hypertension in Africa.~   "
21004|NCT03292081|"~     The aim of this study is to assess clinical safety and efficacy of percutaneous coronary~     intervention (PCI) using a newer generation drug-eluting stent (DES) in the context of~     optical frequency domain imaging (OFDI) guidance or intravascular ultrasound (IVUS) guidance.~   "
21005|NCT03292068|"~     Children recovering from tonsil surgery following day surgery Tonsil surgery - self-care and~     treatment - the TONIST-study The main objective of this study is to evaluate the effect and~     experience of acupuncture, acupressure, specially designed diet and telephone counselling on~     children's surgery-related symptoms, quality of life and costs during recovery after~     tonsillectomy (TE) or tonsillotomy (TT).~      Early discharge from hospitals means that patients have to deal with much of the~     post-operative care during recovery process on their own or with the help of relatives. The~     recovery period may be a progressive process of physical weakness (1,2).~      In Sweden, 14 000 tonsil surgeries per year are performed, about 50% children under 15 years~     because of obstruction, of TE, tonsillectomy, and TT, tonsillomy. Children's tonsil surgery~     following day surgery are in focus for this study. Both qualitative and quantitative methods~     will be used.~   "
21006|NCT03292055|"~     This study aims to evaluate the psychometric properties of a newly developed FFQ specified~     for northern Chinese CHD and their high risk patients (CHD-FFQ). The psychometric properties~     include test-retest reliability, content validity, convergent validity, discriminant~     validity, concurrent validity and predictive validity. Particularly, this study will measure~     the physiological indicators, including plasma lipid profile (i.e. TG, TC, HDL-C, LDL-C), BG,~     BP and BMI twice at baseline and the end. The level of these physiological indicators will be~     compared with the fat intake measured by the CHD-FFQ, i.e. the baseline intake to test its~     convergent validity. It is also expected to predict the diet-related progression of CHD risks~     among high-risk individuals, i.e. patients with two or more CHD risk factors as following:~     raised fasting blood glucose (BG) level, increased blood pressure (BP), increased~     triglycerides (TG), decreased HDL-Cholesterol (HDL-C), increased LDL-Cholesterol (LDL-C),~     smoking and central obesity (International Diabetes Federation, 2015). In addition, this~     study will provide the FFQ's concurrent validity in assessing the intake of energy and~     nutrients against the CDC-FFQ. Moreover, whether the FFQ could detect the known differences~     in energy intake between men and women will be established for its discriminant validity.~   "
21007|NCT03292042|"~     The aim of this study is to evaluate the effectiveness of a lifestyle intervention, to reduce~     the risk of metabolic syndrome in patients with serious mental illness who receive treatment~     with antipsychotic medications.~      The hypothesis of the study is that: the application of a physical health promotion program~     in people with serious mental illness, who receive treatment with antipsychotic medications,~     carried out by a mental health nurse, will decrease the presence of metabolic syndrome and~     contribute to improve their quality of life.~   "
21008|NCT03292029|"~     This pilot study aims to evaluate in an exploratory way the predictive power of a novel in~     vitro test (T50 Calcification Inhibition Test, T50 CIT), which measures the mineralization~     inhibition capacity of blood, in terms of its association with time to all-cause mortality in~     haemodialysis patients.~   "
21009|NCT03292016|"~     A study that compares the extent to which apomorphine becomes available in the body after~     taking either an investigational drug containing apomorphine or apomorphine that is injected~     under the skin in people with PD complicated by OFF episodes.~   "
21010|NCT03292003|"~     The objective of this study is to estimate the safety and performance of Journey II BCS TKS.~   "
21011|NCT03291990|"~     This investigation is not only to develop an improved radiation/temozolomide approach, but~     also develop a regimen with potential to form the basis of better combined therapy with~     immune based treatments.~   "
21012|NCT03291977|"~     Fluorescence guidance is a safe and efficient tool for glioblastomas resection. The most~     widely used technique is based on 5-aminolevulinic acid (5ala), which stains glioblastoma~     cells through a metabolic abnormality and thus helps in defining tumoral edges through a~     modified microscope. A multicentric, randomized study comparing 5ala guided surgery with~     conventional procedures showed that this technique doubles the rate of complete removal on~     post-operative magnetic resonance imaging (MRI), and increases the 6 months progression-free~     survival. More recently, fluorescein appeared as an interesting alternative fluorophore for~     glioblastomas, with a highly reduced cost (2.5 euros versus 1000 euros per dose). However its~     use remains scarcely studied and its clinical benefit unsure. In that context, the~     investigators propose a randomized trial comparing conventional  white light  surgery with~     fluorescein-guided resection of glioblastomas, in order to assess the relevance of this~     technique in glioblastomas removal.~   "
21013|NCT03291964|"~     Pediatric head trauma is a leading cause of morbidity and mortality for children/adolescents.~     The current standard of care regarding imaging modality when concerned for an acute head~     injury is CT. This exposes children to radiation that may predispose to future malignancy.~     Rapid MRI is a test that eliminates radiation and has expanded uses in multiple other areas.~     This study is evaluating it for pediatric acute head trauma.~   "
21014|NCT03291951|"~     FORCE is a randomized home-based resistance training/strength training (RT) intervention~     study for Stage II and III colon cancer patients undergoing chemotherapy.~      Participants will be 180 newly diagnosed Stage II and III colon cancer patients from Kaiser~     Permanente of Northern California (KPNC), the Penn State Cancer Institute (PSCI), and the~     Dana Farber Cancer Institute (DFCI). The intervention will begin within the first weeks of~     adjuvant chemotherapy and continue exercise through the completion of post-operative~     chemotherapy. Specifically, the investigators will examine between group differences for RT~     versus waitlist control for chemotherapy outcomes including dose delays, dose reductions,~     early stoppage and Grade 3 and 4 toxicities. The investigators will also study changes in~     muscle mass (MM) and changes in specific inflammatory markers (e.g. CRP, IL-6 and TNF-RII) as~     potential markers of change in response to RT. To determine effects of change of MM on~     chemotherapy-specific drug clearance, the investigators will examine the impact body~     composition changes on the pharmacokinetics (PK) of 5-FU and oxaliplatin, two of the most~     commonly used drugs for colon cancer.~   "
21015|NCT03291938|"~     This clinical research study has 2 parts: dose escalation and dose expansion.~      The goal of dose escalation in this clinical research study is to find the recommended dose~     of IACS-010759 that can be given to patients with advanced solid tumors or lymphoma.~      The goal of dose expansion in this clinical research study is to learn if the dose of~     IACS-010759 found in the dose escalation part of the study is the best dose to use in future~     studies using IACS-010759 in patients with advanced solid tumors or lymphoma.~      The safety of this drug will also be studied.~      This is an investigational study. IACS-010759 is not FDA approved or commercially available.~     It is currently being used for research purposes only. The study doctor can explain how the~     study drug is designed to work.~      Up to 60 participants will take part in this study. All will be enrolled at MD Anderson.~   "
21063|NCT03291314|"~     Phase II clinical trial on the combination of avelumab and axitinib for the treatment of~     patients with recurrent glioblastoma (histologically confirmed WHO grade IV glioma), at~     documented recurrence/progression following prior treatment with surgery, radiation therapy~     and temozolomide.~   "
21775|NCT03282019|"~     This is a prospective, randomized parallel study for evaluation of the efficacy and safety of~     long-term nocturnal high-flow nasal cannula therapy (HFNC: with the myAIRVO2 as HFNC in this~     study) in stable COPD patients with the global initiative for chronic obstructive lung~     disease (GOLD) stage 2-4, PaCO2 >= 45 Torr and hypercapnia who require home oxygen therapy~     (HOT) using COPD exacerbation (Moderate or Severe).~   "
21016|NCT03291925|"~     This pilot study is a prospective, randomized, open-label trial that aims to assess the~     feasibility of comparing a primary Computed tomography/Cardiac computed tomography~     angiography (CT/CCTA) strategy (test arm) to a strategy combining routine use of CT/CCTA and~     invasive CA (control arm) prior to a Transcatheter aortic valve implantation (TAVI)~     procedure. The study will also estimate the rate of composite coronary adverse events~     (myocardial infarction, post procedural coronary revascularization and cardiovascular~     mortality) between the two arms at 90 days follow-up. The primary endpoint will be the~     feasibility of recruitment and compliance with the study protocol at 2 sites in Canada and 1~     site in Denmark. Additional clinical endpoints including: all-cause death at 90 days post~     procedure, myocardial infarction at 90 days post procedure, unplanned PCI or CABG at 90 days~     post procedure, stroke at 90 days post procedure, CA and PCI related cumulative vascular~     complications events. This information will be used to inform the design of the definitive~     efficacy trial.~   "
21017|NCT03291912|"~     This is a prospective, pragmatic, assessor-blind, randomized controlled trial to explore the~     effectiveness of an adjuvant Chuna manual therapy (CMT) for cervicogenic dizziness of~     Dizziness Handicap Inventory (DHI) ≥ 16 at baseline. Participants will be randomized and~     allocated to either CMT combined with usual care (UC) group or UC group with 1:1 ratio. They~     will receive 12 sessions of CMT or UC treatment for 6 weeks. UC consists of physical therapy~     and patients education.~   "
21018|NCT03291899|"~     This study is to evaluate the response rate and toxicity profile of infusional 5~     fluorouracil, leucovorin, oxaliplatin and irinotecan (FOLFIRINOX) in first-line treatment of~     advanced biliary tract cancers and also to assess progression free survival and overall~     survival of FOLFIRINOX in first line treatment of advanced biliary tract cancers~   "
21019|NCT03291886|"~     The primary objective of this study is to investigate the effect of 5 mg KHK2375 on~     progression free survival (PFS) when administered orally at weekly intervals in combination~     with exemestane in a placebo-controlled, double-blind comparative study in subjects with~     advanced or recurrent hormone receptor-positive breast cancer. The secondary objectives are~     to investigate the effect of on overall survival (OS) and the antitumor effect and to~     evaluate the pharmacokinetics and safety.~   "
21020|NCT03291873|"~     This study will include patients who will undergo PRK in both eyes, for each patient each eye~     will be randomly allocated to one of 2 procedures:~      topography-guided ablation in one eye (group I) and Q-factor customized ablation in the other~     eye (group II).~      Alcon/Wavelight Light Laser Technolo¬gie (GmbH, Erlangen, Germany) will be used for~     photoablation.~      The wavelight Topolyzer (Wavelight AG, Erlan¬gen, Germany) will be used before and 1, 3 and 6~     months after PRK. Refrac¬tive visual outcomes and corneal aberration changes will be compared~     between the two treatment modalities.~   "
21021|NCT03291860|"~     Anti Mullerian hormone (AMH) is gaining place as ovarian marker, chiefly in infertility~     assistance.~      Investigators explored its correlation with oocytes retrieval after long GnRH agonist~     protocol for stimulation, in younger and older infertile population. Methods: This~     prospective analysis compiled data of 66 females, receiving ICSI treatment from April 2016 to~     October 2017. Serum FSH, LH, Estadiol, AMH and antral follicle count were assessed. Outcomes~     were measured as good (5 to 19 oocytes) and bad responders.~   "
21022|NCT03291847|"~     The purpose of this mechanistic study is to evaluate the effects that maternal~     buprenorphine-naloxone maintenance have on the neurobehavioral development of the fetus and~     infant. To accomplish this, the investigators will study a sample of 120 opioid dependent~     pregnant women that will receive buprenorphine-naloxone as part of substance abuse treatment~     at a comprehensive care treatment facility for pregnant and parenting women with substance~     use disorders. Fetal neurobehavior and maternal physiology will be assessed, via an~     established maternal-fetal data acquisition system, at 4 points during gestation: 24, 28, 32~     and 36 weeks. Infant birth parameters and Neonatal Abstinence Syndrome (NAS) spectrum display~     will be evaluated at birth, and infant neurodevelopment will be assessed during the first~     month of life. The investigators will compare the neurodevelopment of the~     buprenorphine-naloxone-exposed fetuses and infants to that of methadone and~     buprenorphine-only exposed fetuses and infants.~   "
21023|NCT03291834|"~     On the basis of a questionnaire the participation at sports activities of children and~     adolescents with type 1 diabetes mellitus will be studied. The occurrence of hypoglycemia and~     hyperglycemia will be evaluated, as well as the measures to prevent these complications.~   "
21024|NCT03291821|"~     Since preimplantation genetic testing (PGT) is being more frequently requested from patients~     as women pursue infertility treatments at an advanced age with a poorer prognosis, sometimes~     physicians are compelled to perform several stimulation cycles to obtain more eggs and,~     consequently, a greater number of biopsied embryos. Hence, the idea of carrying out this~     study arises as an attempt to optimize each menstrual cycle to the maximum.~      It is believed that the double stimulation (DuoStim) protocol could be an alternative for~     this group of patients, allowing to obtain a larger number of oocytes in a shorter period,~     thus, increasing the number of biopsied embryos and possibly decreasing the interval to~     achieve a successful pregnancy.~      The investigators aim to evaluate the potential usefulness of the DuoStim protocol for~     patients desiring to obtain oocytes as soon as possible. Using PGT, the investigators will~     compare the rate of euploid embryos per cycle in patients undergoing DuoStim protocol versus~     patients undergoing two conventional controlled ovarian hyperstimulation in consecutive~     cycles. Patients will include women with advanced age and poor response.~      This is a unicentric, prospective, randomized, non-blind, parallel-group controlled phase IV~     clinical study. The investigators hypothesize that the rate of euploid embryos per cycle is~     similar in the DuoStim group compared to the group undergoing two conventional controlled~     ovarian hyperstimulation in consecutive cycles.~      Furthermore the investigators will evaluate if there are differences regarding the number of~     total oocytes obtained, the number of mature oocytes, the number of biopsied blastocysts and~     the MitoScore index of the available euploid embryos.~   "
21075|NCT03291158|"~     This is a phase 1, safety and PK Open-Label trial evaluating the plasma, epithelial lining~     fluid, and alveolar macrophage concentrations of intravenous Minocin® (Minocycline) for~     injection in healthy adult subjects.~   "
26512|NCT03219957|"~     This study has multiple parts. It will assess the safety, tolerability and pharmacokinetics~     (PK) of AT-527 in healthy subjects and subjects infected with hepatitis C virus (HCV). In~     addition, the study will assess the antiviral activity of AT-527 in subjects infected with~     HCV.~   "
21025|NCT03291808|"~     This is to pilot test a weight loss intervention in obese patients with poorly controlled~     asthma.~      Obesity is a risk factor for the development of asthma (approximately 250,000 cases per year~     of asthma in the U.S. are related to obesity).~      Investigators' ultimate purpose is to test the hypothesis that weight loss through an~     intensive life style intervention will improve asthma control. But investigators first need~     to establish whether the weight loss intervention is effective in patients with asthma.~      Objectives~        1. The primary objective of this study is to determine the effectiveness of an~          internet-based weight loss intervention in producing weight loss in obese patients with~          poorly controlled asthma.~        2. The ultimate purpose is to implement a multi-center weight loss intervention trial for~          obese patients with poorly controlled asthma.~   "
21026|NCT03291795|"~     The purpose of this study is the examine the feasibility of and estimate the efficacy of a~     preoperative exercise (i.e. prehabilitation) program in 40 up to sedentary older adults (i.e.~     age 60 and over) undergoing abdominal, urologic or gynecologic surgery under the Enhanced~     Recovery After Surgery (ERAS) protocol at Duke, using a variety of techniques to measure the~     possible effect of this intervention. Study patients will undergo a program of~     prehabilitation exercise for 6 days per week prescribed for them by an exercise physiologist,~     for up to 4 weeks prior to surgery. Study participants will undergo four types of~     assessments: Functional/Cognitive testing; Blood/cerebrospinal fluid (CSF) samples and Muscle~     biopsies; Brain Imaging; and Brain Activity Recording. Clinical Outcomes will also be~     obtained from the Duke electronic medical record system. The risks of the exercise~     intervention are generally mild, since moderate exercise in this patient population generally~     results in improved health outcomes. Data from these patients will be analyzed in comparison~     to propensity matched patients from the Duke Markers of Alzheimer's Disease and~     neurocognitive Outcomes after Perioperative Care (MADCO-PC) study who did not undergo this~     prehabilitation exercise intervention. Taken together, the results of this study will allow~     the investigators to estimate the possible effect of prehabilitation exercise on multiple~     domains of postoperative recovery (cognition, brain connectivity, biomarkers, brain activity,~     etc) and will provide important preliminary data.~   "
21027|NCT03291782|"~     This initial clinical study in the US will be a randomized, double-blind, placebo-controlled,~     single-dose, dose-escalation, and sequential cohort study to evaluate the safety,~     tolerability, PK and PD of D-0120-NA in fasting, healthy volunteers (HVs).~      In food effect cohort, subjects will each receive 2 doses of D-0120-NA in an open-label~     manner; once in the fasted state and once in the fed state.~   "
21028|NCT03291769|"~     Blood products and intravenous fluids are frequently used in the treatment of children who~     have undergone cardiac surgery in order to maintain hemodynamic stability. Optimal hematocrit~     values during CPB are still being discussed in children undergoing congenital cardiac~     surgery. The overall complication rate for transfusion in adults is 2.5 complications per~     1000 units, while 10.7 complications per 1000 transfusion in children. The aim of this study~     is to investigate the effects of the our transfusion strategies used in pediatric cardiac~     surgery on duration of intensive care unit, duration of postoperative mechanical ventilation~     and mortality.~   "
21029|NCT03291756|"~     This prospective, non-interventional research registry is designed to study the comparative~     effectiveness and comparative safety of approved treatments for MS in a cohort of patients~     cared for by neurologists across North America. Secondary objectives include analyzing the~     epidemiology and natural history of the disease, its comorbidities, and current treatment~     practices.~   "
21030|NCT03291743|"~     Pursuing very early diagnosis is standard of care for several diseases including colon~     cancer, diabetes and liver disease where an early and aggressive diagnostic and therapeutic~     approach has been shown to change their natural history. Crohn's disease [CD] still lags~     since commonly at presentation CD has already run a long course, often responding poorly to~     therapy or requiring surgery. This innovative project proposes a minimally invasive strategy~     - capsule endoscopy-based screening of first degree relatives [FDR's] of CD patients - to~     develop tools to diagnose CD at or near its biologic onset.~   "
21031|NCT03291730|"~     The investigators are conducting a project to provide a new type of resource called hand~     lettering to patients receiving chemotherapy. This is a type of art therapy. The goal of~     this project is to understand if it is feasible to use art-therapy and to describe anxiety~     before and after completing hand-lettering.~   "
21032|NCT03291717|"~     The purpose of this study is to test a peer-led intervention intended to promote the~     community living and participation of individuals with psychiatric disabilities entitled~     Bridging Community Gaps Photovoice (BCGP). The intervention targets increasing community~     involvement of individuals with psychiatric disabilities through reduction in self-stigma and~     perceived stigma, enhancing opportunities for community participation, and support to achieve~     community participation goals.~   "
21033|NCT03291704|"~     The purpose of this pilot study is to determine the feasibility of at home thermal therapy~     with a wireless, portable device, as an effective management of Meibomian Gland Dysfunction.~      This will be done by assessing patients for improvement in symptoms and ocular oil gland~     function after 4 weeks of a daily thermal therapy application.~   "
21034|NCT03291691|"~     Peripheral nerve blocks can be conducted with ultrasound, electrical nerve stimulation or~     landmark technique or a combination of this techniques. Whether a regional block should be~     conducted with a combination of those different possibilities is highly discussed. In this~     study the investigators want to show the effectiveness of new standard way of combined use of~     ultrasound and nerve stimulation, they call protective nerve stimulation. According to~     ethical vote we are conducting an observational study.~   "
21035|NCT03291678|"~     Impact of percutaneous internal ring ligation during laparoscopic orchiopexy in decreasing~     incidence of congenital hernia~   "
21036|NCT03291665|"~     This study will compare the thickness of the plantar fascia in stretched and relaxed~     positions in patients with plantar fasciopathy using ultrasonography.~   "
21037|NCT03291652|"~     The study is to attain early recognition of the unstable plaques which have an imminent~     embolic risk in patients with intracranial atherosclerotic disease (IAD).~   "
24766|NCT03242837|"~     This study evaluates the influence of a resilience training on psychobiological factors which~     are related to stress and resilience in young healthy male cadets. Half of participants will~     join in the resilience training, while the other half take part in a control-training~     (diversity management training).~   "
21038|NCT03291639|"~     Human Tc17 cells (IL-17-producing CD8+ T cells) have been found to contribute to different~     kinds of human inflammatory and malignant diseases. Previous studies indicate that Tc17 cells~     can convert to Tc1 cells (IFN-γ-producing CD8+ T cells) in tumor bearing mice to exert~     anti-tumor effect. Base on these results in murine models, human Tc17 may have potential in~     developing cancer immunotherapy. However, there is limited evidence to reveal the~     characteristics and functional plasticity of human Tc17 cells. In this proposal, we aim to~     optimize the differentiation of Tc17 cells and then investigate whether the reprograming of~     Tc17 to Tc1 cells can promote the anti-tumor cytotoxicity. Preliminarily, we isolated CD8+ T~     cells from the peripheral blood mononuclear cells of healthy donors to induce Tc17~     differentiation. Human CD8+ T cells were stimulated with anti-CD3/anti-CD28 antibodies,~     TGF-β, IL-1β, IL-6, IL-23, IL-2, anti-IFN-γ, and anti-IL-4 antibodies. After 10 days in~     culture, there were 4% of IL-17A+IFN-γ- and 7% of IL-17A+IFN-γ+ CD8+ T cells. However, IFN-γ+~     CD8+ T cells still represented high percentage, although it's significantly lower than that~     in Tc1 cells. Our preliminary study demonstrated that Tc17 cells expressed lower levels of~     cytotoxic molecules than Tc1 cells. We will further test if the expressions of cytotoxic~     molecules, including perforin and granzyme B, and EOMES will be enhanced by various~     cytokines. Ultimately, we will evaluate the functional plasticity of Tc17 cells under various~     cytokine stimulation. Collectively, success of this project will establish more insight for~     human Tc17 cells and provide the information for future developing human CD8+ T cell-mediate~     immunotherapy.~   "
21039|NCT03291626|"~     Postoperative delirium is a condition in which patients develop temporary difficulties in~     maintaining attention and thinking clearly. These new problems can appear after surgery and~     change throughout the day. This confusion can last several days.~      The overall purpose of this study is to measure brain activity during sleep and wakefulness~     to learn about their relationships to delirium after surgery. While participants may not feel~     like their normal self during the study, they are in the best position to help us learn how~     to improve the recovery of brain function and sleep in others having surgery. The~     investigators need to learn from those who have and have not become confused after their~     surgical procedure.~   "
21040|NCT03291613|"~     Sickle cell disease (SCD) is a common genetic disorder characterized by episodes of pain, yet~     assessments to identify type, intensity, frequency, and phase of pain among SCD adolescents~     is lacking. Research shows that interactive gaming technology can enhance adolescents'~     learning, and can be especially effective in delivering health-related messages and tools to~     improve their self-care. Pinpoint is an interactive gaming tablet app that will be developed~     with the significant input of clinical experts to assist SCD teens with better identification~     and self-report of their pain.~   "
21041|NCT03291600|"~     Perinatal depression occurs in 15% of pregnant women and new mothers, yet as few as 1 in 5~     receive adequate treatment. It has a negative impact on the woman herself, as well as a~     potential for serious consequences for her child. Virtual psychiatric care is a potential~     model that may provide accessible mental health care during this time, as barriers to~     in-person care often include unpredictable infant schedules, competing childcare demands, or~     travel/cost challenges. The Virtual-PND intervention consists of 12-weeks of the option of~     supplementing in-person psychiatric care with secure, in-home real-time video-visits through~     the Ontario Telemedicine Network. This pilot RCT will demonstrate the feasibility of~     proceeding to a future large-scale RCT evaluation of virtual psychiatric care for this~     population.~   "
21042|NCT03291587|"~     Evaluate a multi-faceted training program to improve short-term smoking cessation rates (<14~     days post-visit) and short (3 months) and sustained abstinence (6 months) among 1,114~     enrolled smokers who present for LDCT lung cancer screening in 26 community-based practices.~   "
21043|NCT03291574|"~     Evaluate the effect of Perioperative Electroacupuncture on rapid rehabilitation for the~     gastric cancer patients after gastrectomy .~   "
21044|NCT03291561|"~     Evaluate the effect of perioperative electroacupuncture on rapid rehabilitation for the~     pancreatic cancer and periampullary carcinoma patients after operation .~   "
21045|NCT03291548|"~     Cardiovascular disease (CVD) is one of the most common chronic diseases in older populations,~     which has been increasing in line with rising overweight and obesity levels in recent years.~     Dietary intake is a major modifiable risk factor for CVD, and one such recommendation is to~     increase the intake of essential (omega-3) polyunsaturated fats in our diets, for example by~     consuming more oily fish. We know, however, from large population level dietary surveys, that~     many individuals within the United Kingdom (UK) population are not consuming enough oily~     fish. Therefore, alternative dietary sources of omega-3 polyunsaturated fats are required to~     help meet consumer needs.~      Quinoa is a traditional Andean seed crop consumed in a similar fashion to staple cereal~     grains in Europe, and the popularity of quinoa has been growing worldwide because of its~     nutritional content and perceived healthiness. Quinoa contains a small amount of fat, but the~     ratio of omega-6 and omega-3 essential fats is more favourable in quinoa than in other plant~     oils. An opportunity therefore exists to incorporate quinoa flour into more frequently~     consumed food products (e.g. biscuits) as an alternative means of increasing consumers~     omega-3 intake.~      The purpose of this study is to investigate the effect of consuming quinoa-enriched biscuits,~     compared to control, on markers of CVD risk over 4-weeks in older adults.~   "
21046|NCT03291535|"~     Investigators are examining the quality improvement impact of providing patients with a an~     electronic health record-connected blood pressure cuff. Investigators will give half of~     patients already eligible for hypertension management within a clinical pharmacist panel, the~     ability to upload their blood pressure data into Stanford's electronic health record.~   "
21047|NCT03291522|"~     The objective of this study is to use ultrasound-guided rete testis flushing and aspiration~     technique to retrieve sperm, non-surgically, from the testes of azoospermic men. If sperm are~     retrieved by this method, it will provide a direct benefit to the infertile men. This~     protocol will also establish the safety and feasibility of the ultrasound-guided rete testis~     injection approach in consenting men before the approach is translated to teenage boys.~   "
21048|NCT03291509|"~     The purpose of this study is to compare different weight loss programs in people with IDD to~     see which program works better.~   "
37849|NCT03071211|"~     This is a randomized controlled trial comparing plug-unplug catheter management, continuous~     drainage catheter systems and patients that do not get discharged with catheters after~     inpatient pelvic reconstructive surgery.~   "
21049|NCT03291496|"~     Sepsis has its greatest impact in the prematurely born (preterm) population. Neonatal sepsis~     (sepsis within the first month of life) causes over one million deaths worldwide annually,~     and is one of the most common, difficult and costly problems to diagnose, treat and prevent.~     The preterm infant can suffer rates of sepsis up to 1000-fold higher than the full-term~     infant, and bears the brunt of the associated mortality and lifelong sepsis-survivor~     morbidity.~      The project is enabled by several novel, validated, microfluidic technologies that are robust~     and easy to use with little training. These technologies provide comprehensive measures of~     the functionality of blood PMN population; a critical cellular component of innate immunity.~     The study team will also extract high-quality nucleic acids from microfluidic-sorted PMNs for~     transcriptomic analyses. Collectively, these techniques require a total of 250 microliters~     (µL) of blood, which makes them particularly useful for preterm infants where sample volume~     is limited, and facilitates serial assessments with unprecedented temporal resolution of key~     functions of PMNs.~      These studies, integrated with bioinformatics approaches, will generate new tools for~     diagnosing sepsis in the newborn and predicting clinical outcomes. Such approaches have the~     capability to dramatically change the clinical management of the preterm infant, and~     potentially improve long-term outcomes while reducing hospital costs.~   "
21050|NCT03291483|"~     Purpose: The purpose of this study was to determine whether whole body vibration with~     plyometric training has effect on physical performance parameters and balance also this study~     searched for if vibration support additional benefits to normal plyometric training. Methods:~     24 elite basketball players divided into two group as 12 players with the mean age of 24 ±~     6,96 years (Study Group) and 12 players with the mean age of 22,45 ± 5,22 years (Control~     Group). Plyometric training were applied to study group on whole body vibration platform for~     6 weeks (2 days/week) with routine basketball training, in control group plyometric training~     were applied on whole body vibration platform with the similar period of time but platform~     had been closed. All the assessments (physical measurement, vertical and horizontal jump~     tests, one-repetition maximum (1-RM) half squat strength test, 20 m speed test, T agility~     test, sit and reach flexibility test, star excursion balance test) were applied before and~     after 6 weeks plyometric training for both groups.~   "
21051|NCT03291470|"~     A randomized, double-blind, placebo-controlled, multi-center, phase 3 study to determine the~     efficacy and effectiveness of TG-C in subjects with Kellgren and Lawrence Grade 2 or 3~     Osteoarthritis of the Knee, Osteoarthritis Research Society International (OARSI) medial~     joint space narrowing (JSN) Grade 1 or 2 of the knee joint. TG-C is to be administered by a~     single intra-articular injection to the damaged joint area via ultrasound guidance. Patients~     will be followed for 24 months for safety and efficacy.~   "
21052|NCT03291457|"~     This prospective, multicenter, observational study will evaluate the use of concomitant~     glucocorticoid therapy in adults with rheumatoid arthritis (RA) being treated with~     tocilizumab in daily clinical practice. Participants will be observed for up to 52 weeks~     after starting treatment with tocilizumab. All visits and assessments will be performed as~     per routine clinical practice, with no study-specific visits or interventions.~   "
21053|NCT03291444|"~     The main purpose of this study is to verify the safety and potential effectiveness of CART~     cells combined with peptide specific dendritic cell in relapsed/refractory leukemia.~   "
21054|NCT03291431|"~     The purpose of this study is to evaluate the efficacy of intermittent theta burst repetitive~     transcranial magnetic stimulation (iTBS) as a treatment for Veterans with an alcohol use~     disorder (AUD) to decrease the exceedingly high rate of relapse associated with this~     condition. iTBS has demonstrated equivalent efficacy and safety to repetitive transcranial~     magnetic stimulation employing 10Hz stimulation protocols in treatment of depressive~     disorders. The advantage of iTBS is that it can be delivered in approximately 5 minutes where~     conventional 10Hz repetitive transcranial magnetic stimulation (rTMS) protocols are typically~     20-25 minutes. It is hypothesized that Veterans with AUD who receive active iTBS applied to~     the left dorsolateral prefrontal cortex (DLPFC), compared to controls (i.e., Veterans with~     AUD who receive sham iTBS), will show significant decreases alcohol craving, depressive~     symptomatology and cigarette consumptions, as well as improved neurocognition, a longer~     period of abstinence, and a lower overall rate of relapse over 6 months following standard~     psychosocial treatment for AUD at VA substance treatment clinics. In exploratory analyses, it~     is also predicted that magnetic resonance measures of left DLPFC glutamate concentration,~     volume of anterior frontal cortical brain regions, and performance on fMRI tasks~     interrogating the function of the salience/reward circuits will serve as biomarkers of iTBS~     treatment response. The goal of this proposal is to implement treatment that effectively~     promotes sustained abstinence in Veterans with AUD, given long-term abstinence is related to~     optimal neurobiological, neuropsychological and psychosocial recovery and functioning.~   "
21055|NCT03291418|"~     A Double-Blind, Controlled Study to Compare the Gastrointestinal Safety of a 14-Day Oral~     Dosing Regimen of ATB-346 to Sodium Naproxen in Healthy Subjects~   "
21056|NCT03291405|"~     It is Correlation Between Body Mass Index and Gonadotrophin Secretions in Pcos Patients and~     Their Effect on Ivf Outcome~   "
21057|NCT03291392|"~     The purpose of the study are:~        1. To make quality, characterized samples and related data available for future studies,~          including Genome Wide Association Studies (GWAS), genomics, and biomarker research;~        2. To use these samples and related medical information to answer research questions aimed~          at understanding the genetics and underlying biology of acquired disease and injury to~          the brain, heart and blood vessels with the express purpose of advancing the search for~          effective modalities for prevention, treatment, and recovery;~        3. To develop additional operational infrastructure to support this project across the~          Prince of Wales Hospital and divisions, including (1) tracking of patient consent, (2)~          management of collection and sample processing processes, (3) sample inventory and QC/QA~          processes, and (4) release of materials to investigators for further research.~   "
21058|NCT03291379|"~     This is a pilot, open label single arm phase 0 window of opportunity study of~     vandetanib-eluting radiopaque beads in patients with resectable liver malignancies.~   "
24767|NCT03242824|"~     This proposal is for a pilot study comparing volumes of 18F-DOPA-PET avidity with contrast~     enhancement and T2 FLAIR on MRI. Investigators then plan to compare patterns of failure with~     target volumes, pre-treatment MRI changes and pre-treatment 18F-DOPA-PET.~   "
21064|NCT03291301|"~     This study will examine the use of cognitive behavioural therapy (CBT) and acupressure in~     treating insomnia in Chinese adults. The main components of CBT for insomnia (CBT-I) includes~     psychoeducation, sleep restriction, stimulus control, cognitive restructuring, and~     relaxation. CBT-I is widely used in western countries but it fails to address patient~     preference among Chinese adults with insomnia, as demonstrated in a previous study examining~     the subjective experience of chronic insomnia in Hong Kong Chinese adults. The study revealed~     that Chinese adults showed distrust in hypnotics and preferred traditional Chinese medicine~     (TCM) which was believed to be more natural. In order to maximize the therapeutic effects of~     psychological interventions for insomnia, integrative medicine with a combination of CBT-I~     and TCM could be an alternative to address insomnia in the Chinese population. Acupressure, a~     non-invasive therapy, is commonly used in TCM. It is suggested that acupressure can induce~     relaxation and improve sleep quality. Some studies have demonstrated the separate efficacy of~     CBT-I and acupressure in treating insomnia. However, few studies have examined the effect of~     their combination.~   "
21065|NCT03291288|"~     This study has two parts.~      Part 1 will evaluate how pexidartinib affects the way the body processes CYP3A4 and CYP2C9~     substrates using midazolam and tolbutamide, respectively, as probe agents.~      Part 2 will test the efficacy and safety of pexidartinib treatment in various tumor types.~      In Part 2, the same participants will continue to receive pexidartinib twice daily.~      Participants will be allowed to continue using pexidartinib as long as the participant~     derives benefit.~   "
21066|NCT03291275|"~     This study aims to determine survival outcomes (overall survival and progression-free~     survival) of primary uterine malignancies in China and relevant risk factors in a prospective~     cohort study.~   "
21067|NCT03291262|"~     This study aims to determine survival outcomes (overall survival and progression-free~     survival) of primary ovarian malignancies in China and relevant risk factors in a prospective~     cohort study.~   "
21068|NCT03291249|"~     This is a randomized, placebo-controlled, four-arm, double-blind study. Subjects will be~     randomized (1:1:1:1) to receive either a daily oral placebo solution or a daily oral dose of~     0.5 mg, 2.5 mg or 5.0 mg Foralumab Solution for 30 consecutive days. Subjects will record~     adverse events and daily administration of study medication in a subject diary. This will~     serve as a measure of compliance and record of safety and tolerability. Subjects will be~     followed up for 30 days following completion of treatment.~      Study visits performed on Days 14, 30 and 60 of the study, will monitor metabolic parameters~     (body mass index [BMI] and waist circumference), serum lipid profiles, immunological markers~     (c-reactive protein [CRP] and an array of cytokines), hepatic enzymes and functions~     (13C-methacetin breath test [MBT]) and liver steatosis/fibrosis, which will be compared to~     baseline levels (Day 1).~      The safety and tolerability of the treatment regimen will be determined by monitoring vital~     signs, laboratory values, adverse events and physical findings throughout the study. In~     addition, its efficacy will be established upon either reduced Day 30 serum alanine~     aminotransferase (ALT) levels, reduced hemoglobin A1c (HbA1c) or improved homeostasis model~     assessment (HOMA) or HOMA of insulin resistance (HOMA-IR) scores as compared to baseline (Day~     1). In addition, to assess the efficacy of the tested Foralumab Solution regimen in improving~     overall subject status, a battery of exploratory metabolic, immunologic and hepatic markers~     will be evaluated on Days 30 and 60.~   "
21069|NCT03291236|"~     This study aims to determine survival outcomes (overall survival and progression-free~     survival) of primary malignancies of uterine cervix in China and relevant risk factors in a~     prospective cohort study.~   "
21070|NCT03291223|"~     The Gaucher Outcomes Survey (GOS) is an ongoing observational, international, multi-center,~     long-term Registry of Patients with Gaucher Disease irrespective of their treatment status or~     type of treatment received. No experimental intervention is involved. Patients undergo~     clinical assessments and receive care as determined by the patients' treating physician.~      The objectives of the registry include to evaluate the safety and long-term effectiveness of~     velaglucerase alfa, to characterize patients receiving velaglucerase alfa or other Gaucher~     Disease-specific treatments, to gain a better understanding of the natural history of GD and~     to serve as a database for evidence-based management of Gaucher Disease over time in~     real-life clinical practice.~   "
21071|NCT03291210|"~     Hyperoxemia can produce various complications including oxidative stress and myocardial~     injury. We hypothesized that the normoxic group would have lower myocardial injury compared~     to hyperoxic group after transcatheter aortic valve replacement.~   "
21072|NCT03291197|"~     Shoulder-hand syndrome (SHS) in stroke patients is painful and lowers quality of life.~     Unfortunately, the cause of SHS is not known, diagnosing SHS can be difficult, and treating~     it can be hard. Recent research has shown that certain nerve blocks are good for treating~     shoulder pain for stroke patients, but no one has looked specifically as SHS. Investigators~     think that specific nerve blocks involving a shoulder nerve (the suprascapular, or SSc nerve)~     and a hand nerve (the median nerve) will be helpful in reducing SHS pain. Investigators will~     use ultrasound guidance to accurately inject these nerves. These injections have never been~     described for SHS patients however, so investigators want to make sure people with SHS can go~     through with the injections without too much pain or discomfort. That is, the investigators~     want to test the tolerance of these injections for people with SHS. Investigators are also~     hoping to better understand how consistent a set of diagnostic criteria, called the Budapest~     criteria, are at diagnosing SHS in order to be able to accurately diagnose this condition.~   "
21073|NCT03291184|"~     The main objective of this study is to describe the incidence of postoperative residual~     paralysis (mean train-of-four <90%) when weaning from the ventilator in patients admitted to~     the Intensive Care Unit (ICU) after elective cardiac surgery. Train-of-four monitoring is a~     widely used term for the peripheral nerve stimulation used in neuromuscular blockade~     monitoring. When the patient is ready for weaning from the ventilator, an ICU doctor will~     perform a measurement of the train-of-four at the thumb with a neuromuscular transmission~     monitor. Every value below 90% will be considered as residual paralysis and treated~     appropriately by means of a reversal agent.~   "
21074|NCT03291171|"~     The aim of this study is to investigate whether and how 'MyPlan 2.0' helps adults with type 2~     diabetes to be more physically active or less sedentary. Two groups will be created, an~     intervention group and a waiting-list control group.~   "
37850|NCT03071198|"~     Clinical effect of neoadjuvant hierarchical treatment based on chemotherapy for T3-4N0-2M0~     middle and lower rectal cancer~   "
21076|NCT03291145|"~     The projects will try and optimise the risk stratification for patients with Long QT syndrome~     by investigating how the exposure of physical and acoustic stress will affect the QT-dynamics~     and if beta blockers protect against arrhythmias by suppressing this dynamic QT-prolongation.~     Furthermore, the project will investigate the effects of Spironolactone on the QT-dynamics~     tested by Brisk Standing.~      First, patients are tested with known arrhythmic triggers and they are then administered~     thier normal dose of beta blockers. Hereafter, Brisk Standing test is performed and the~     patients are on Spironolactone for seven days. After seven days treatment the Brisk~     Standing is repeated.~   "
21077|NCT03291132|"~     This study aims to evaluate the effectiveness of the Smoke-free Teens Programme in~     strengthening youth's knowledge and attitude on smoking and health.~      The objectives are:~      i. To evaluate Smoke-free Teens' change in knowledge on smoking hazards, attitudes towards~     smoking, tobacco control and smoking cessation, and practices for promoting smoking~     prevention and cessation, ii. To evaluate the process and quality of smoke-free programmes~     organized by the Smoke-free Teens in their schools/community, and iii. To measure the number~     of people whom the Smoke-free Teens will deliver the smoke-free messages to.~   "
21078|NCT03291119|"~     CVJ anomalies affecting skeleton might lead to the pressure on the neuraxis, and disturbance~     of the cerebrospinal fluid circulation and blood supply. The patients undergoing surgeries on~     CVJ might develop airway complications in immediate postoperative period warranting urgent~     reintubation or emergency tracheostomy. Reintubation is usually difficult in immediate~     postoperative period due the fixation of cervical spine and gross upper airway oedema due to~     prolonged surgery in prone position. This will be the first prospective observational study~     to find out the risk factors related to patient, anaesthesia, radiological findings and~     surgical procedure to predict extubation failure in patients undergoing CVJ surgeries.~   "
21079|NCT03291106|"~     In patients diagnosed as endometrial cancer by thorough pathologic examinations, Lynch~     syndromes are screened by (1)immunohistochemical staining (for MLH1, MSH2, MSH6 and PMS2),~     (2) tests of microsatellite instability and (3) clinical criteria (Amsterdam I or II criteria~     and Bethesda criteria). For patients with any suspicious discoveries of Lynch syndromes from~     aforementioned screening methods, a molecular diagnosis with next-generation sequencing for~     mismatch repair genes (MLH1, MSH2, MSH6, PMS2, and EPCAM) is given to confirm Lynch~     syndromes. For patients of Lynch syndromes and endometrial cancer, relatives of blood lineage~     are tested by Sanger method or qPCR to find out carriers of mutation genes of Lynch~     syndromes.~   "
21080|NCT03291093|"~     Rationale: Amyloid beta (Ab) is mainly known for its role in Alzheimer's disease (AD)~     pathology. However, Ab seems not only to be involved in AD pathology, but also in~     atherosclerosis, which might explain the remarkable similarities in risk factors between~     these two pathologies. In vitro studies suggest that a major part of this association is~     based on the ability of amyloid to lead to macrophage activation and thus inflammation. These~     data lead to the hypothesis that Ab is associated with plaque vulnerability.~      18F-Flutemetamol is a PET tracer with high affinity for Ab. This has been extensively studied~     in AD patients.~      Objective: To validate 18F-Flutemetamol PET in the evaluation of plaque vulnerability.~      Study design: A cross-sectional validation study. Study population: 25 adults, who have~     recently (<14days) experienced a transient ischemic attack (TIA) or stroke with a carotid~     artery plaque of ≥30% and without evidence of another etiology than carotid atherosclerosis~     (i.e. cardiac or small vessel).~      Of these 25 patients, 10 patients will be included who have been scheduled for carotid~     endarterectomy (CEA). The other 15 will be selected of patients who are not scheduled to~     undergo CEA.~      Intervention: All patients will undergo a PET/MRI scan with 18F-Flutemetamol, either before~     the scheduled CEA or within the first 30 days following the cerebrovascular event. Imaging~     will include the carotid and coronary arteries as well as the brain.~      Main study parameters/endpoints: Tracer uptake in the carotid artery will be correlated to~     vulnerable plaque characteristics as assessed by MRI. In the 10 CEA patients, tracer uptake~     and MR imaging of different plaque characteristics will be validated with plaque histology of~     the surgically removed specimen.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: There is no additional benefit for study subjects. Study subjects will receive~     the same treatment as non-participating patients. Patients will be screened for in- and~     exclusion criteria to minimize risks.~      For optimal MR imaging patients will be injected with a Gadolinium based contrast agent,~     which is a common procedure and associated with very low risk of complications. The PET~     tracer 18F-flutemetamol has been studied extensively and is currently used in patients with~     AD. Adverse events were not frequent and mainly mild. The radioactivity dose will be around~     6.8 mSv.~   "
21081|NCT03291080|"~     An open label, randomised, multiple dose, cross-over relative bioavailability and~     pharmacokinetics trial of a novel oral liquid and capsule formulations of 13-CRA administered~     to patients from 0 months - < 21 years.~   "
21082|NCT03291067|"~     The purpose of this study is to assess the efficacy and safety of MT-8554 for treatment of~     vasomotor symptoms (VMS) associated with menopause.~   "
21083|NCT03291054|"~     Primary objective is to assess the efficacy of combined IDO and PD-1 inhibition in a single~     arm phase II trial of epacadostat and pembrolizumab in patients with advanced~     imatinib-refractory GIST, using a primary endpoint of overall response rate.~      Secondary objectives are to evaluate the progression free survival (PFS), the overall~     survival (OS), the response rate and to evaluate the safety and tolerability of combined~     epacadostat and pembrolizumab treatment.~      The investigator hypothesizes that treatment with epacadostat and pembrolizumab will increase~     the response rate compared to what has been historically achieved with salvage tyrosine~     kinase inhibitors.~   "
21084|NCT03291041|"~     A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With~     Jet Lag Disorder~   "
21085|NCT03291028|"~     This is a comparative study using resected/ biopsied tumors samples collected from renal cell~     carcinoma and urothelial carcinoma patients who underwent surgical removal of lesions,~     followed by immune checkpoint blockade (ICB) treatment targting programmed cell death 1 (PD1)~     but developed new lesions later were also removed and stored in the biosample repository~     (BSR). The histology and genomic analysis of the pre-treatment and metastatic samples from~     the same patient would be used to find out the changes that may have lead to metastasis.~     Also, metastatic samples from ICB naive patients would be collected and compared with those~     from ICB treated patients to find out if the metastasis in treated patients was due to~     development of reistance.~   "
21086|NCT03291015|"~     To Compare Between Radiological Guided Treatment And Arthroscopic Guided Treatment Of~     KIENBOCK Disease~   "
21087|NCT03291002|"~     This study evaluates intratumoral CV8102 in patients with advanced melanoma, squamous cell~     carcinoma of the skin, squamous cell carcinoma of the head and neck, or adenoid cystic~     carcinoma.~      Patients will receive CV8102 as single agent or in combination with SoC anti-PD-1 therapy.~   "
28479|NCT03194217|"~     This phase 2b study is designed as multicentre, multinational, randomized, double blind,~     parallel group and placebo controlled with three doses of Bavisant (0.5, 1, and 3 mg/d) in~     subjects with excessive daytime sleepiness with Parkinson's disease.~   "
21089|NCT03290976|"~     Chemotherapy-induced peripheral neuropathy (CIPN) is a common and often debilitating~     complication of cancer treatments. There is presently no known treatment which can prevent~     the onset of CIPN, with treatment of existing symptoms limited to reducing the dose intensity~     of the offending agent. Clinical research has shown that complementary/integrative medicine~     (CIM) modalities such as acupuncture and reflexology may be effective in relieving~     CIPN-related symptoms. The present study will included 120 patients suffering from~     CIPN-related symptoms, and will take place at 3 medical centers in Israel which provide CIM~     treatments to oncology and hemato-oncology patients. Participants will be allocated to either~     the control arm (standard conventional supportive care; n=40) or to the intervention arm of~     the study (standard care with CIM treatments; n=80), based on their preference. Patients in~     the treatment arm of the study will be randomly allocated to either twice-weekly, single~     modality acupuncture treatments (n=40), or to a multi-modality treatment program (n=40),~     which will include acupuncture and additional CIM modalities (i.e., manual-movement and~     mind-body therapies), for a 6-week period.~      The effect of CIM treatments in reducing the severity of CIPN-related symptoms will be~     assessed at baseline and at 6- and 9-week follow-up visits, using the Functional Assessment~     of Cancer Therapy -Taxane (FACT-Tax) tool; the European Organization for Research and~     Treatment of Cancer Quality of Life Questionnaire - C30 (EORTC QLQ-C30); and the Measure~     Yourself Concerns and Well-being (MYCAW) questionnaire. Interim assessment of symptom~     severity will be conducted by the study nurse throughout the study period, through either~     telephone or e-mail. Additional study outcomes will include the safety of the CIM treatments;~     QOL-related concerns which may affect CIPN-related symptoms (e.g., anxiety, depression, sleep~     disturbances, etc.), as well as issues related to body image and coping with CIPN;~     physiological assessment of CIPN using a von Frey test (with hairs of varying diameters to~     assess the threshold for touch evoked sensations); and adherence to the planned oncology~     treatment regimen, as measured by the Relative Dose Intensity (RDI) calculation.~   "
21090|NCT03290963|"~     The purpose of this research study is to compare the antidepressant effect of lithium versus~     placebo in adults receiving ketamine. Lithium is available commercially for depression;~     ketamine is available commercially and can help the symptoms of depression; however, it has~     not been approved by the U.S. Food and Drug Administration (FDA) for this use. The FDA has~     allowed the use of this drug in this research study.~   "
21091|NCT03290950|"~     This is a study to test the safety and effectiveness of the study drug, daratumumab in~     combination with carfilzomib, lenalidomide and dexamethasone. The purpose of this study is to~     test whether giving daratumumab along with the other drugs (carfilzomib, lenalidomide and~     dexamethasone) is safe for patients.~   "
21092|NCT03290937|"~     Any time the words you, your, I, or me appear, it is meant to apply to the potential~     participant.~      The goal of this clinical research study is to find the highest tolerable dose of irinotecan~     that can be given in combination with PF-05082566 and cetuximab to patients with advanced~     colorectal cancer. Researchers also want to learn about possible side effects of the study~     drugs and if the study drug can help to control the disease.~      This is an investigational study. PF-05082566 is not FDA approved or commercially available.~     It is currently being used for research purposes only. Cetuximab and irinotecan are FDA~     approved and commercially available to treat several types of cancers, including colorectal~     cancer. Their use in combination with PF-05082566 is investigational.~      The study doctor can describe how the drugs are designed to work.~      Up to 32 participants will be enrolled in this study. All will take part at MD Anderson.~   "
21093|NCT03290924|"~     This study assesses the effect of a low-dose, high-frequency training approach on long-term~     evidence-based skill retention among skilled birth attendants and impact on adverse birth~     outcomes at hospitals in Ghana.~   "
21094|NCT03290911|"~     The main objective of this study is to analyze management of Controlled Ovarian Stimulation~     (COS) protocols in low prognosis patients, secondly to observe the clinical outcomes~     (Fertilization Rate, Pregnancy Rate, the Ongoing Pregnancy Rate and the Live birth Rate) and~     the total units of gonadotrophins consume per M2 oocyte retrieved in this subgroup.~   "
21095|NCT03290898|"~     To evaluate if physical exercise intervention leads to an improved asthma control as measured~     by Asthma Control Questionnaire (ACQ-5) in such a magnitude that inhaled corticosteroid can~     be reduces in asthmatics.~   "
21096|NCT03290885|"~     Mechanical thrombectomy (MT) with a stent retriever (SR) device is now the standard~     intervention in ischemic stroke with large vessel occlusion. Favorable outcome is strongly~     associated with the successful reperfusion status. New device of MT such as contact~     aspiration seems promising to increase reperfusion status and clinical outcome.~      The main hypothesis is to show the superiority of combining the use of contact aspiration~     with a stent retriever compared to a stent retriever alone in treatment of acute stroke due~     to proximal arterial occlusion.~      The primary endpoint is the rate of perfect reperfusion score at the end of the endovascular~     procedure.~   "
21097|NCT03290872|"~     Recently published work has suggested that mitral valve annuloplasty ring type may affect the~     development of post-repair mitral stenosis resulting in adverse intracardiac hemodynamics and~     poor functional status. However, these results have not been comprehensively determined in a~     systematic manner on a general mitral valve repair population. As well, an underlying~     mechanism for these findings is not understood.~      The investigators hypothesize that mitral valve repair with a complete annuloplasty ring~     (Carpentier-Edwards Physio II) when compared to repair with a partial annuloplasty ring~     (Simplici- T) may not necessarily result in elevated mitral gradients consistent with~     functional mitral stenosis (FMS). Currently no prospective data exists to test the hypothesis~     that a correctly sized, flexible complete annuloplasty ring has detrimental effects.~      As 60% of annuloplasty rings used in surgical repair of degenerative mitral valve disease in~     North America utilizes one of the many forms of complete flexible rings available, this~     information is urgently required.~      The investigators will evaluate: 1) the effect on mitral valve hemodynamics, 2) changes to~     mitral annular, valvular and subvalvular structure and function with 3D echocardiography, and~     3) the effect on patient functional capacity at 1 year.~      If FMS early post repair is a real phenomenon, the investigators hope to better understand~     the mechanisms through the use of advanced imaging techniques-namely 3D modeling of the~     mitral valvular apparatus, aortic mitral interactions and LV remodeling.~   "
21098|NCT03290859|"~     Prospectively evaluate newly established guidelines and make clinicians aware of inter-racial~     difference in propofol sensitivity.~   "
21099|NCT03290846|"~     15 healthy males will be studied with PET/CT, using FDG to investigate glucose metabolism,~     and radiowater to investigate perfusion. One scan will be performed in controlled cold~     exposure, to see whether subjects have cold activated brown adipose tissue. Two scans will be~     performed in room temperature conditions, where all subjects are blinded and randomised to~     receive placebo and secretin hydrochloride. PET/CT scans will be analysed blinded.~   "
28480|NCT03194204|"~     Rheumatoid Arthritis (RA) is a chronic inflammatory disease characterized by joint swelling,~     joint tenderness and destruction of synovial joints, leading to severe disability and~     premature mortality.~   "
21100|NCT03290833|"~     The effectiveness of robotic over conventional therapy is arguable and the best therapy~     strategy is still not clear. Basing on the existing evidence on motor learning and~     practice-induced neuroplasticity, the investigators plan to use an exoskeleton robotic hand~     to enhance the rehabilitation volume in the subacute stage of stroke patients. The robotic~     system allows intensive and customized training of hand and finger movements. The aim of this~     study is (1) to establish whether robot assisted therapy provides any additional motor~     recovery for the hand when administered during the subacute stage in a Chinese adult~     population diagnosed with stroke; (2) to evaluate the feasibility and efficacy of~     robot-assisted hand rehabilitation in improving arm function abilities in subacute hemiplegic~     patients.~   "
21101|NCT03290820|"~     Nasopharyngeal carcinoma (NPC) is one of the most common maligancies of China. In the era of~     intensity-modulated radiotherapy (IMRT), the 5-year overall survival (OS) has now reached~     85.0% or more. However, even after chemoradiation, the 5-year distant-metastasis rate of~     patients with N2-3 NPC is still 36.7%. Aspirin is proven in lab and clinical studies to have~     the abilities of inhibiting the inflammation which could enhance metastasis of breast and~     colorectal cancers. And before this study, it was discovered that regular aspirin intake~     might be associated with distant-metastasis-free survival (MFS) and OS independently. So this~     Phase 2 trial was conducted to validate the impact of aspirin on prognosis of N2-3 NPC.~   "
21102|NCT03290807|"~     Evaluation of the diagnostic value of SPECT/CT in patients with knee and/or hip OA, whether~     it is related to clinical findings and it could reflect clinical disease activity, and to~     determine the usefulness of SPECT/CT in early detection of OA.~   "
21103|NCT03290794|"~     The proposed regulatory post-marketing surveillance (PMS) study will be planned to collect~     the safety data of aflibercept intravitreal injection in patients with wet Age-related~     Macular Degeneration (AMD) in real-life treatment practice.~      The primary objective is:~      - To collect safety data in wet AMD patients treated with intravitreal aflibercept injection~      The secondary objective is:~      - To determine how disease activity is monitored including type and frequency of ocular tests~     and frequency of injections~   "
21104|NCT03290781|"~     The purpose of this study is to evaluate the efficacy of SHP647 as maintenance therapy in~     participants with moderate to severe ulcerative colitis (UC) who achieved clinical response~     in induction studies. This is a phase 3, randomized, double-blind, placebo-controlled,~     parallel-group efficacy and safety study.~   "
21105|NCT03290768|"~     This study allows Type 2 diabetics to receive feedback from a continuous glucose monitor~     (CGM) as part of an educational program designed to help them better manage their glucose~     levels. Subjects will also wear an activity tracker to monitor their activity and observe its~     effect on their glucose levels. The educational program will involve calls from coaches to~     check subjects' progress and answer questions.~   "
21106|NCT03290755|"~     The main objective of this study is to analyse sexual behavior of HIV + MSM in Bordeaux, who~     have sexually contracted hepatitis C between January 1st 2013, to January 31, 2017. These~     data will bring some improvement about prevention and maybe reduced the hepatitis C~     incidence.~   "
21107|NCT03290742|"~     Investigators plan to perform a review of medical records a single urology department to~     identify patients with febrile perioperative infection who underwent radical cystectomy and~     urinary diversion for bladder cancer from January 2014 to July 2017.~      Investigators plan assess a potential variables to find correlation with infections after~     surgery.~      Characteristics, including age, sex, length of hospital stay, body mass index (BMI),~     diabetes, hypertension, estimated glomerular filtration rate (eGFR), preoperative~     hydronephrosis, smoking status, neoadjuvant chemotherapy, pathological stage, lymph node~     involvement, types of urinary diversion, operative method (open/laparoscopic), operative time~     and receipt of a perioperative blood transfusion (PBT) will be asses as potential risk factor~     for perioperative infection.~   "
21108|NCT03290729|"~     This study was designed as a multicentric prospective clinical trial to assess the clinical,~     biological and patient's perceived success of new wedge-shaped dental implants inserted in~     narrow ridges.~   "
21109|NCT03290716|"~     The DECIDE - Salt in Elderly (Diet, ExerCIse and carDiovascular hEalth - Salt Reduction~     Strategies for the Elderly in Nursing Homes in China) is to evaluate the effects, safety and~     cost-effectiveness of salt substitution (SS) and stepwise salt supply control (SSSC) in~     reducing blood pressure in Chinese elderly in nursing homes. The study will recruit over 1080~     old people from 36 nursing homes in northern China. The 36 nursing homes will be randomised~     into the following 4 groups.~        1. salt substitute (SS) and stepwise salt supply control (SSSC);~        2. SS only;~        3. SSSC only; and~        4. no SS and no SSSC (control).~      The intervention will last over 2 years.The randomization will be conducted centrally after~     the baseline survey completed. Primary outcome will be the change in systolic blood pressure.~     The secondary outcomes include: the changes in diastolic blood pressure, 24hr urinary sodium,~     potassium and microalbumin, and incidence of hyperkalemia and cardiovascular events, and~     incremental cost-effectiveness ratio.~   "
21110|NCT03290703|"~     The purpose of this study is to evaluate the PK of GDC-0853 following changes to formulation~     and in the presence or absence of food, the proton pump inhibitor (rabeprazole), or both.~     This will be a 3-part open-label randomized study conducted in healthy adult participants.~     Approximately 63 subjects will be enrolled in this study.~   "
21111|NCT03290690|"~     This is a non-randomized, single-blind post market clinical follow-up study for which 65~     patients will be imaged at Rouge Valley Centenary Hospital (Scarborough and Rouge Hospital)~     who present with a chronic wound and are receiving standard wound care treatment. The~     MolecuLight i:X imaging device will be used by the study clinician as an adjunctive tool in~     the assessment of the wound and will be used to guide the targeted sampling of a wound (with~     curettage scraping), as per current standard of care in the principal investigator's wound~     care clinic. The acquired tissue sample will then be analysed using conventional gold~     standard semi-quantitative culture methods to determine bacterial species present, also as~     per current standard of care in this clinic.~   "
21112|NCT03290677|"~     This research study is studying cryoablation (a treatment to kill cancer cells with extreme~     cold) combined with continued treatment with current immune checkpoint inhibitor as a~     possible treatment for lung cancer.~   "
21113|NCT03290664|"~     This is a phase II trial of related donor HLA-haploidentical NK-cell based therapy for the~     treatment of newly diagnosed acute myelogenous leukemia (AML) (except acute promyelocytic~     leukemia) in persons who failed to achieve a complete remission (CR) after one or two~     standard induction attempts. Failure is defined as ≥ 30% bone marrow blasts in a bone marrow~     of at least 20% cellularity at the mid-cycle (~day 14) bone marrow biopsy or residual AML on~     ~day 28 bone marrow biopsy by morphology, flow, PCR or FISH.~   "
21114|NCT03290651|"~     Breast cancer remains a major killer of women and despite major advances in care, the role of~     'environmental factors' in the disease remain to be well understood. The investigators have~     shown that one such factor is the bacteria that inhabit the breast tissue. These bacteria do~     not cause infections per se, but can produce low amounts of substances known to be able to~     induce cancer. The investigators have found that the bacteria in the breasts of women with~     cancer are very different from those found in the breast tissue of healthy women. The~     investigators would like to test their theory that taking probiotic lactobacilli by mouth can~     lead to these organisms reaching the breast tissue and help to displace the harmful bacteria~     and reduce inflammation which has close links to cancer.~   "
21115|NCT03290638|"~     The objective of this randomized clinical study was to evaluate the use of dehydrated human~     amnion-chorion membrane as an exposed barrier for guided bone regeneration (GBR) after tooth~     extraction and to determine whether intentional exposure of this membrane to the oral~     environment compromises ridge dimensions and bone vitality for implant placement.~   "
21116|NCT03290625|"~     Parallel clinical trial focusing on procedural pediatric sedation in the dental setting.~     Children will be randomized to treatment according to a predetermined sequence of~     interventions consisting of: 1. intranasal sedation with ketamine-associated dexmedetomidine~     (Experimental Group), 2. intranasal sedation with dexmedetomidine as sole drug (Control~     Group). Primary outcome is children's behavior during the dental treatment. Secondary~     outcomes are: children's pain, memory and stress (salivary cortisol and melatonin);~     perception of the accompanying adult, dentist and child about dental sedation;~     cost-effectiveness of this type of sedation; psychosocial variables; children's quality of~     life.~   "
21117|NCT03290612|"~     This study will test the efficacy of Vitamin C to counteract morning CV risk markers in a~     randomized, double blind, placebo controlled crossover pilot study. The participants will~     also perform morning typical behaviors such as arousal from sleep, change in posture (getting~     out of bed) and mild intensity physical activity; identical to the stressors encountered in~     everyday life. Primary dependent variables are markers of cardiovascular risk including~     vascular endothelial function and oxidative stress.~   "
21118|NCT03290599|"~     Post-operative cognitive dysfunction is defined as a decrease in cognitive functions which~     develop following surgery and anesthesia administration that can last up to weeks or even~     months after surgery. In this study, our main objective was to investigate the effect of~     preoperative hospitalisation period on early post operative cognitive dysfunction development~     and its risk factors in patients who underwent total hip replacement surgery for hip~     fractures under regional anesthesia.~   "
21119|NCT03290586|"~     This is a longitudinal, multi-center study to be conducted in at least five institutions from~     the private surgeon offices. These surgeons will collect data from X-rays, wound~     complications \and hardware complications.~   "
21120|NCT03290573|"~     Up to 90% of catheters fail before therapy is complete. Improved dwell time of intravenous~     catheters for even small increments of time would further reduce the number of insertions,~     staff workloads, and costs. In this study, the investigators investigated whether short~     peripheral venous catheter site of insertion influence the dwell time.~   "
21121|NCT03290560|"~     This is a Phase II study to assess the safety and tolerability of DM199 in acute ischemic~     stroke patients. The study will be randomized, placebo controlled at multiple centers.~   "
21122|NCT03290547|"~     To evaluate the safety and efficacy of an investigational version of the Cutera enLighten~     laser that offers muliple wavelengths for tattoo removal.~   "
21123|NCT03290534|"~     This is a feasibility study to determine the usefulness of a brachytherapy device that~     utilizes active components (palladium-103) of standard devices in a novel configuration,~     which may benefit lung cancer patients by reducing the radiation dose to critical structures,~     such as the heart wall, while giving a therapeutic dose to diseased tissue, such as at a~     surgical margin.~   "
21124|NCT03290521|"~     The aim of the present study is to evaluate the role of intraperitoneal washing irrigation~     with saline solution at the end of laparoscopic hysterectomy or myomectomy in reducing~     perception of postoperative pain.~   "
21125|NCT03290508|"~     This is a long-term prospective registry study to determine whether Prolaris testing in~     patients with favorable intermediate risk prostate cancer influences physician management~     decisions toward conservative treatment in patients with Prolaris low-risk scores without~     negatively impacting patient oncologic outcomes, thereby sparing low-risk patients from~     unnecessary treatments and associated side-effects.~   "
21126|NCT03290495|"~     Ketamine effect on isoflurane anesthesia This study is designed to study the effect of~     ketamine on isoflurane anesthesia. As both drugs are hypnotic and are used to cause sleep~     during surgery and other painful procedures, it was long believed that the actions of two~     drugs add to each other. For example if a man received both drugs, this man will become awake~     from anesthesia much later than if this man was given either of them alone.~      However recent studies showed that this is not the case and ketamine can cause fast recovery~     from hypnotic effects of isoflurane. This was confirmed in animals.~      The aim of current study is to investigate if this effect applies for humans, using a state~     of art brain monitoring device in wide use nowadays called BIS or bispectral index. This~     device can also shed some light on how ketamine can cause, if any, fast recovery from~     isoflurane anesthesia. Simply, by studying electrical wave coming from brain to head skin.~   "
21127|NCT03290482|"~     Researchers are trying to understand the course of Eosinophilic Esophagitis (EoE), its~     progression and effects of treatments.~   "
21128|NCT03290469|"~     Prospective, multi-site, study to evaluate the clinical utility of cWGS in a proband. One~     group will receive cWGS and a clinical report approximately 15 days after blood samples are~     received, while the other group will continue to receive standard of care until Day 60. The~     standard of care group will receive cWGS and a clinical report at Day 60 as part of secondary~     and tertiary analyses. Both groups will be followed for a total of 90 days.~   "
21129|NCT03290456|"~     Immunosuppressive therapy of granulomatosis with polyangiitis (GPA, Wegener's) and~     microscopic polyangiitis (MPA) has transformed the outcome from death to a strong likelihood~     of disease control and temporary remission. However, most patients have recurrent relapses~     that lead to damage and require repeated treatment associated with long-term morbidity and~     death.~      Rituximab has been shown to be as effective as cyclophosphamide to induce remission and~     maintenance of remission in severe GPA and MPA patients, with an acceptable safety profile .~     Although rituximab is becoming the standard of care for maintenance therapy in these~     patients, relapse still occurs and the optimal duration of prednisone therapy remains~     debated.~      On the one hand, most US studies use early withdrawal (6-12 months) because of feared side~     effects. On the other hand, most European trials propose late withdrawal (>18 months) given a~     lower observed relapse rate on long-term low dose glucocorticoids treatment.~      In a systematic review and meta-analysis, glucocorticoids regimen was the most significant~     variable explaining the variability between the proportions of ANCA-associated vasculitis~     patients with relapses. Nevertheless, it was an indirect estimation of treatment effect~     because of the absence of dedicated randomized trial. This meta-analysis concluded that~     combined longer-term (i.e. >12 months) use of low dose prednisone or nonzero glucocorticoids~     target is associated with a 20% reduction of relapse compared to early withdrawal (i.e. ≤12~     months).~      The relapse rate in patients with early glucocorticoids (10-12 months) withdrawal was~     provided in two studies and was of 37 and 34%, respectively. By contrast, the relapse rate in~     patients with late prednisone withdrawal (18-24 months) and receiving rituximab as~     maintenance treatment was 14% at 24 months in the MAINRITSAN trial. Of note, the decision to~     withdraw glucocorticoids after 18 months was left to physician's discretion in this study and~     two thirds of the nonsevere relapses occurred when patients were off prednisone.~      The trial detailed here is the first prospective trial evaluating the length of~     glucocorticoid administration as remission adjunctive treatment for patients with GPA or MPA.~   "
21130|NCT03290443|"~     This is a multi-center, open-label study to assess the PK of single 100 mg oral dose of~     enasidenib (CC-90007) in subjects with moderate and severe hepatic impairment, and in matched~     healthy control subjects with normal hepatic function.~      Degrees of hepatic impairment will be determined during screening by the subject's score~     according to Pugh's Modification of Child's Classification of Severity of Liver Disease~   "
21131|NCT03290430|"~     The purpose of this research is to study a smoking cessation program for adult smokers in~     Northeast Ohio. The study will also look at how different people respond to the program.~   "
21132|NCT03290417|"~     The purpose of this study is to see if eating vitamin D, omega 3 and turmeric (curcumin)~     slows the growth of prostate cancer in men on active surveillance.~   "
21133|NCT03290404|"~     Axillary block is the good anesthetic technique for upper limb surgery without exceeding a~     certain total dose injected of Local Anesthetic (AL).~      The maximal recommended dose of Lidocaine adrenaline in the upper limb is 500 mg. The use of~     ultrasound helps guiding the locoregional anesthesia, and allows to decrease the AL~     concentration, thus decreasing the risks.~      No previous study estimated a concentration of lidocaine lower than 1,5 % to realize upper~     limb surgery by axillary block.~      The literature overestimating probably the rate of failure of the locoregional anesthesia~     under ultrasound-guidance, we suggest to estimate the rate of failure of the axillary block~     ultrasound-guided with the lidocaine 1 % adrenaline for realizing upper limb surgery in~     standard practice.~   "
21134|NCT03290391|"~     This study, Linking Infectious and Narcology Care - Part II (LINC-II), will implement and~     evaluate a multi-faceted intervention (LINC-II), via a two-armed randomized controlled trial~     among 240 HIV-infected PWID in St. Petersburg. LINC-II, comprised of pharmacological therapy~     (i.e., rapid access to ART and receipt of naltrexone for opioid use disorder) and 12 months~     of strengths-based case management, will assess HIV outcomes (e.g., HIV viral load~     suppression), impact on care systems and cost-effectiveness of the intervention.~   "
21135|NCT03290378|"~     The study evaluates the effectiveness and safety of IV tramadol compared to placebo managing~     postoperative pain following a bunionectomy~   "
21136|NCT03290365|"~     Although platelet rich plasma (PRP) and Hyaluronic acid (HA) are beneficial for~     osteoarthritis of knee (OA knee), the combined effect of PRP with HA was not clear so far.~     Hence, investigator assess a prospective randomized double-blind controlled trial.~   "
21137|NCT03290352|"~     This study shed light on an under-researched area by examining the prognostic associations of~     pre-treatment QoL with overall survival and distant metastasis free survival among patients~     with head and neck cancer who underwent free flap reconstruction. In addition, a validated~     instrument specific to head and neck cancer, i.e. the University of Washington Quality of~     Life Questionnaire (UW-QoL) was adopted.~   "
21138|NCT03290339|"~     Hysterectomy is one of the most performed surgery in women. Public authorities wish that~     one-day surgery become a majority and hysterectomy could be part of it in the future. The aim~     of this study is to determine the feasibility of ambulatory hysterectomy.~      Patients and methods: Investigators will realize an observational descriptive survey based on~     questionnaires in two surgical gynecology units. Women under 70 years old, who undergo~     hysterectomy will be included.~   "
21139|NCT03290326|"~     Alzheimer's Disease (AD) is characterized by amyloid-β (Aβ) plaque buildup and phosphorylated~     tau (p-tau) in the brain, as well as widespread neurodegeneration. The evidence suggests that~     both amyloid and tau play a critical role in AD and interventions that reliably and safely~     decrease the intracerebral burden of amyloid or tau could potentially be of marked clinical~     importance. Currently, therapeutic options are very limited and while there are pharmacologic~     interventions that transiently improve cognitive function, there are no treatments that alter~     disease progression. The current study seeks to use a novel therapeutic intervention that~     uses noninvasive brain stimulation to target amyloid in the brain. The investigators~     anticipate this will decrease the amyloid levels in the brain, as evidence by Positron~     Emission Tomography (PET) imaging.~   "
21140|NCT03290313|"~     Shu gan yi yang capsule is made of traditional Chinese medicine Guizhou Yi Bai pharmaceutical~     Limited by Share Ltd, for liver and kidney deficiency and liver and kidney deficiency and~     blood stasis caused by functional impotence and mild arterial insufficiency in impotence,~     impotence, flaccid penis not hard or lift and not firm, chest deep sigh, chest fullness,~     soreness and weakness of waist and knees, pale tongue or petechiae, pulse string or string.~     The choice of depression associated with erectile dysfunction patients, and investigate its~     effect.In this study, patients with depression and erectile dysfunction were selected and the~     efficacy was investigated~   "
21141|NCT03290300|"~     Evaluation of long-term (2-year) quality of life after nasal airway obstruction treatment~     with the Aerin Vivaer Stylus~   "
21142|NCT03290287|"~     The purpose of this study is to evaluate the potential cardiovascular safety concerns and~     all-cause mortality described in the risk management plan for aclidinium bromide, through~     sequential, nested case-control studies for each endpoint of interest~   "
21143|NCT03290274|"~     Approximately one million of Spaniards suffer from AlzhEimer´s Disease (AD) and this figure~     is expected to triple by 20150. The approved treatments modulate neurotransmission in general~     and are not specific or anatomically directed. In AD there is a dysfunction in cognitive and~     memory circuits. It has been shown that the deep brain stimulation (DBS) can specially~     modulate circuits in such a way that is modulable, and this approach is safe. The safety of~     this treatment and its biological effects are convincing enough to require further study of~     possible therapeutic effects of DBS in AD. The objectives are: To evaluate the security of~     DBS in AD (main objective). To study the influence of DBS in the progress of AD, to compare~     the effects of DBS on the brain metabolism neural connectivity and hubs using MEG, and to~     compare the effects between two different groups: fornix and Basal nucleus of Meynert (BNM).~     To achieve this, a prospective, double-blind comparison study between groups will be~     conducted, to evaluate the effects of DBS in 6 patients: group I (fornix) and group II (~     BNM).~   "
21144|NCT03290261|"~     Half of the women present an episode of cystitis once in their lives. A recurrence occurs in~     about 20% to 30% of the patients, and half of these patients will make more than 4 episodes~     per year, defining recurrent cystitis (CR).~      Complications such as pyelonephritis are rare (less than 0.5% of patients in the absence of~     underlying complication), however, CRs are responsible for a significant impact on women but~     also on society. Pain is at the forefront, but also the fear of not managing pollakiuria,~     with its social exclusion. The impact on sexuality is major. The medical circuit imposed on~     the patients is long and arduous. The clinical assessment sometimes reveals favorable~     factors, variable in pre- or post-menopause, but in the majority of cases, no explanatory~     cause can resolve the problem and some authors suggest resignation as a classic reaction to~     this problem. The only study on psychological disorders associated with recurrent cystitis~     suggests patients who are much more anxious than the average of female.~      Hypnotherapy is an old technique, used for care in Western societies for at least two hundred~     years. By the word, the practitioner induces in the patient a particular state of~     consciousness characterized by an indifference on the outside and a hyper suggestibility.~     This hypnotic state of consciousness can be used to amplify the patient's internal~     resources to fight against anxiety and pain, and to eliminate symptoms.~      The physiological mechanisms at work in hypnosis are the subject of recent studies becoming~     more and more precise. The results of these studies made it possible to objectify changes in~     cerebral functioning related to hypnotic trance.~      A report by Inserm of 2015 confirms the effectiveness of this practice in hypnosedation,~     hypnoanalgesia and hypnotherapy, particularly in irritable bowel syndrome, although the~     methodology to be used in its evaluation is difficult and subjective. The principal~     investigator hypothesizes that the symptoms presented in recurrent cystitis (pain, anxiety)~     can be improved by hypnotherapy, and that thus the prognosis of this pathology can be totally~     modified.~      In the absence of any study published in the literature, the investigator propose an~     intervention pilot study with minimal risks and constraints monocentric prospective~     non-randomized prospectively in 15 patients.~      The main objective of this project is to demonstrate that hypnotherapy improves the~     psycho-emotional parameters of patients suffering from recurrent cystitis after 3 hypnosis~     sessions combined with home exercises performed by the patient. The evaluation will be~     carried out during the last session of hypnosis.~   "
21145|NCT03290248|"~     This is a Prospective, Controlled, Double Blinded, Single Center, Randomized, 3 Arm, Parallel~     Assignment, Phase 1b/2a Study to assess the safety, tolerability, and preliminary efficacy of~     B244 delivered as an intranasal spray in healthy volunteers and subjects with seasonal~     allergic rhinitis.~   "
21146|NCT03290235|"~     1. To further evaluate the safety and efficacy of PEG-Somatropin in the treatment of~          children with growth hormone deficiency for a relatively long period~        2. To explore the factors influencing the efficacy of PEG-Somatropin and to establish the~          height prediction model based on Chinese children with short stature, and to provide the~          basis and guidance for standard and reasonable long-term clinical application of~          PEG-Somatropin.~   "
21147|NCT03290222|"~     The TRACK (Test for Respiratory and Asthma Control in Kids) questionnaire is a validated~     instrument to evaluate the control of respiratory symptoms in young children. The TRACK~     questionnaire was developed in English and a version in Portuguese is not available or~     validated, purpose of the present project.~   "
21148|NCT03290209|"~     The purpose of this study is to explore the clinical outcomes of laparoscopic D1~     lymphadenectomy for elderly patients with advanced gastric adenocarcinoma（cT2-4a, N-/+, M0）~   "
21149|NCT03290196|"~     Patients undergoing shoulder rotator cuff surgery in an outpatient setting are the focus of~     this study. The purpose of this study is to determine if the product EXPAREL® can be used as~     a safe alternative in shoulder surgery to pain pumps, while limiting narcotic use and~     providing appropriate postoperative pain control.~   "
21150|NCT03290183|"~     To date, the different biopsy methods, such as CT-guided pleural biopsy, mediastinal biopsy,~     endosonography and thoracoscopy have their limitations in diagnosing pleural malignancies,~     such as mesothelioma. Sampling errors frequently occur resulting in the common histological~     finding of 'non-specific pleuritic/fibrosis', which presents a great uncertainty for~     clinicians and patients. Confocal laser endomicroscopy (CLE) provides real-time imaging on a~     cellular level, however data of CLE in pleural malignancies are lacking.~   "
21151|NCT03290170|"~     This is a randomized study comparing the measured resection and gap-balancing surgical~     techniques for total knee replacement (TKR) using a cemented Journey II TKR implant system.~     We will be comparing the two surgical methods by evaluating implant migration using~     radiostereometric analysis (RSA) imaging, evaluating contact kinematics (knee mechanics)~     through RSA under dynamic conditions and comparing patient knee outcome scores.~   "
21152|NCT03290157|"~     This study evaluates the impact of a SPA on Quality of bowel preparation for colonoscopy.~     Half of the patients receive regular paper based information on colonoscopy preparation~     (control), while the other half will use an additional SPA for colonoscopy preparation~     (coloprAPP).~   "
21153|NCT03290144|"~     There have been substantial advances in care for individuals with CF, including improved~     nutrition and respiratory care. Women with CF are now likely to survive into adulthood with a~     median predicted survival of 49.7 years in 2012, which have resulted in increasingly normal~     lifestyles, including successful pregnancies in women with CF. The number of pregnancies in~     CF women has increased as reported by the 2013 Annual Data Report from the French CF Registry~     (6 pregnancies in 1992 to 53 in 2012). Pregnancy adds many physiological stresses to the~     body, particularly on pulmonary function (decrease in residual volume, expiratory reserve~     capacity) and nutritional status (increase in nutritional needs). In women with CF, these~     added stresses could theoretically affect survival, with difficulties to maintain adequate~     nutrition and an unpredictable effect on lung function. A number of studies published over~     the past 15 years have attempted to clarify the risk of pregnancy in women with CF to guide~     clinicians and women. Many authors compared the outcomes of pregnant CF women to non-pregnant~     CF women regardless of nutritional status, lung function, diabetes mellitus, bacteriological~     colonization. In literature, pregnancy was possible and well tolerated in CF women with mild~     disease if associated with more intensive monitoring and aggressive treatment during~     pregnancy, with particular emphasis on nutrition and weight gain. CF women have an increased~     likelihood of receiving treatment for diabetes both during and after pregnancy. Furthermore~     diabetes mellitus has been associated with more severe pulmonary disease, more frequent~     pulmonary exacerbations, poorer nutritional status and a reduced life expectancy.~     Pre-pregnancy diabetes mellitus is associated with a poorer prognosis for pregnancy in~     general population. Severe forms of CF, including pre-pregnancy diabetes mellitus might as~     well do badly with accelerated decline after pregnancy. To determine the effect of~     pre-pregnancy diabetes on maternal decline after pregnancy, we will compare FEV1 and BMI~     rates of decline, during a two-years follow-up period after pregnancies, reported in the~     French CF Registry, according to their diabetic status.~   "
21154|NCT03290131|"~     Multiple Sclerosis (MS) is an acquired inflammatory demyelinating disease of the central~     nervous system (CNS) that is regarded as the foremost cause of non-traumatic neurologic~     disability in adults in North America. Spasticity is a common complication in MS and occurs~     in up to 84% of patients. The main sign of spasticity is resistance to passive limb movement~     characterized by increased resistance to stretching, clonus, and exaggerated deep reflexes.~     Osmotica Pharmaceutical is currently developing arbaclofen extended-release tablets (AERT)~     for the treatment of spasticity in patients with MS.~   "
21155|NCT03290118|"~     This is an online study that aims to test the effectiveness of Interpretative Nutrition~     Rating Systems (INRS) such as the Health Star Rating System (HSR or Star System), traffic~     light system and warning labels (high sodium, saturated fat and sugar) proposed by Health~     Canada. The study will incorporate the use of a Smartphone application (app), FoodFlip®, to~     help educate consumers on each INRS prior to their exposure on food packages.~   "
21156|NCT03290105|"~     Ventilator-associated pneumonia (VAP) is the most frequent life-threatening nosocomial~     infection in the ICU. Oropharyngeal colonization with bacterial pathogens is the first step~     toward lung infection. Oral hygiene with Chlorhexidine mouth wash (CMW) is among the most~     widespread preventive measure to prevent VAP. Precise microbial documentation of CMW efficacy~     on oropharyngeal colonization is lacking. Investigators wish to determine CMW antimicrobial~     efficacy in ICU ventilated patients and to measure chlorhexidine residual concentration in~     patients' saliva at the same time-points after CMW.~   "
21157|NCT03290092|"~     Segmental overgrowth disorders are rare conditions characterised by abnormal growth which is~     usually asymmetric and confined to discrete parts of the body. We and others have identified~     mosaic activating mutations in the p110α catalytic subunit of phosphatidylinositol-3-kinase~     (PI3K; encoded by the PIK3CA gene) in a subset of overgrowth disorders. The PI3K-AKT-mTOR is~     a critical signalling pathway, which regulates cellular growth, proliferation and survival.~     Activating mutations in PIK3CA lead to increased activation of the PI3K-AKT-mTORC1 axis,~     which in turn promotes excessive growth in affected tissue.~      The PIK3CA-related overgrowth spectrum is wide, and depends upon the timing of the founder~     mutation in embryogenesis, and potentially upon the exact mutation. Clinical presentation~     ranges from isolated enlargement of a digit, to extensive overgrowth of limbs, abdomen and in~     some cases the brain, and may be accompanied by vascular or lymphatic malformations.~     Associated morbidity can be profound, with functional impairment, debilitating haemorrhages~     and thromboses, coupled with neurological sequelae and, in some cases, death. At present,~     serial debulking surgery is the only available therapeutic option.~      The identification of gain-of-function mutations in PI3K has raised the possibility of~     treatment with drugs that inhibit PIK3CA (the p110 alpha catalytic subunit of PI3K).~     Taselisib is a selective inhibitor of class I PI3Ks and has direct inhibitory activity of the~     p110α isoform with a Kiapp value of 0.29 nmol/l.~   "
21158|NCT03290079|"~     The purpose of this study is to:~        -  Assess overall radiographic response rate (ORR)~        -  Assess progression-free survival (PFS)~        -  Test the safety and tolerability of Pembrolizumab~   "
21159|NCT03290066|"~     Determine the effectiveness of kinesiotaping on pain in primary dysmenorrhea.~   "
21160|NCT03290053|"~     Patients with acute ischemic stroke in anterior circulation within 4,5 hours of symptom~     onset, has a bone window and Trombolysis In Brain Ischemia (TIBI) <=4 in a relevant artery~     eligible. Both patients receiving thrombolysis and those who do not due to contraindications~     such as anticoagulation or recent surgery are enrolled, but into different study arms (CE-5S~     A for thrombolysis and B for non-thrombolysis); the decision to treat with thrombolysis or~     not is done according to clinical routine.~      All included patients are randomized to receive transcranial ultrasound and SonoVue-infusion~     or sham-ultrasound and placebo; i.e. in CE-5S A, contrast enhanced sonothrombolysis is~     compared to thrombolysis and in CE-5S B, contrast enhanced sonolysis is compared with~     conservative management.~      Main outcome is improvement in National Institute of Health Stroke Scale (NIHSS) at 24 hours~     compared to baseline. Main safety outcome is symptomatic intracerebral haemorrhage.~   "
21161|NCT03290040|"~     The research program explores how aging influences brain function in test-persons from a~     Danish birth cohort of men born in 1953.~   "
21162|NCT03290027|"~     Enrollment of subjects with mild to moderate facial acne. Subjects with acne lesions of any~     severity on the chest and/or back (including shoulders) may be enrolled provided they have~     mild to moderate acne on the face. During the 12-week treatment period subjects will use the~     study product twice daily. Subjects will be instructed to treat the entire face (and chest~     and/or back including shoulders, if applicable).~      Efficacy will be assessed by using an Investigator's Global Assessment scale (IGA 5 point~     scale) and by counting the number of inflammatory and non-inflammatory lesions on the face at~     Baseline and Weeks 4, 8, and 12.~      Safety assessments will include the investigator's assessment of local cutaneous tolerance of~     the treated skin (dryness, non-lesional erythema, peeling, stinging, burning, and itching;~     assessed separately on the chest and/or back including shoulders (if applicable), vital signs~     (blood pressure and pulse rate), and adverse events (AEs). Urine pregnancy tests will be~     performed at Baseline and at every visit through Week 12 for all female subjects. A physical~     examination will be performed.~   "
21163|NCT03290014|"~     Patients with COPD, in addition to daytime symptoms, may suffer from nocturnal disturbances.~     The frequency of nocturnal problems has been reported to be higher in COPD than in the~     general population and it currently affects up to 50% of patients.~      The CASIS questionnaire includes 7 questions and it has been recently validated as an~     objective tool to evaluate nocturnal symptoms in patients with asthma and COPD. The present~     study aims to study the validity of the CASIS questionnaire as a predictor of sleep quality~     measured by objective polysomnographic parameters.~   "
21164|NCT03290001|"~     This is a prospective, observational cohort study aimed to explore the influence of anxiety~     and depression to long term survival in nasopharyngeal carcinoma patients.~   "
21249|NCT03288896|"~     This study consists in the the design, implementation, and evaluation of the first web-based~     computer tailored intervention program aimed at the prevention of binge drinking in Spanish~     adolescents (Alerta Alcohol). A Cluster Randomized Controlled Trial is conducted to test the~     effectiveness of Alerta Alcohol in students aged 16 to 18 years across 16 high schools from~     Andalusia (southern Spain), which are randomized either to the experimental or the control~     condition (EC and CC).~   "
21165|NCT03289988|"~     Natural killer cells (NK cells) are cytotoxic lymphocytes that play an important role in the~     innate immune system. In particular, it plays a very important defense function against host~     cells or cancer cells infected with a specific virus. Recent studies have shown that the~     activity of NK cells is decreased in patients with various carcinomas compared with normal~     controls, suggesting that the measurement of activity of NK cells in the blood may be helpful~     in the early diagnosis of cancer. In a recent study analyzing NK cell activity in 762~     patients undergoing colonoscopy, NK cell activity showed performance in diagnosing advanced~     colorectal adenoma and colorectal cancer with sensitivities 42.2% and 85.7%, and specificity~     58.3% and 59.5%, respectively. This finding suggests that NK cell activity may be useful as a~     screening method for colorectal neoplasms. However, as a single test, this diagnostic power~     is relatively low. On the other hands, another blood-based colorectal cancer screening test~     that using 29 gene panels algorithm has recently been reported. According to this study, 29~     gene panel algorithms (Colox®) showed performance in diagnosing advanced colorectal adenoma~     and colorectal cancer with sensitivity of 55.4% and 79.5% and specificity of both 90.0%,~     respectively. for diagnosis of advanced adenoma and colorectal cancer, respectively. Although~     the Colox® test seems to be useful for the colorectal cancer screening using blood test, this~     diagnostic power is relatively low. In order to overcome low diagnostic performance of~     aforementioned tests (NK activity and Colox®) as a single use, combination of individual~     biomarkers can be a promising alternative. In this regards, the aim of this study was to~     evaluate the diagnostic value for predicting advanced colorectal neoplasms by combining~     Colox® and NK cell activity indicators.~   "
21166|NCT03289975|"~     Today there are few studies in the literature involving patients in an ICU following major~     visceral surgery. There are thus few results about the prognostic value of pulmonary~     extravascular water in this population of patients, but also the prognostic value of~     pulmonary extravascular water measured at the bedside using pulmonary ultrasound.~      In addition, pulmonary ultrasound will be combined with echocardiography to measure left~     ventricular function (LVEF) and to study the profile of the mitral valve to assess filling~     pressure in patients with immediate post-operative ventilation. This will make it possible to~     distinguish between increases in pulmonary extravascular water associated with high filling~     pressure and increased pulmonary water associated with low filling pressure: characteristic~     of lesional oedema.~      The aim of this study is to determine the prognostic value of extravascular pulmonary water~     (PEVW) diagnosed using pulmonary ultrasound in patients admitted to an ICU following~     scheduled or emergency visceral surgery in the onset of acute respiratory distress requiring~     invasive mechanical ventilation, or prolonged post-operative intubation, or non-invasive.~   "
21167|NCT03289962|"~     This is a Phase 1a/1b, open-label, multicenter, global, dose-escalation study designed to~     evaluate the safety, tolerability, immune response, and pharmacokinetics of RO7198457 as a~     single agent and in combination with atezolizumab (MPDL3280A, an engineered anti-programmed~     death-ligand 1 [anti-PD-L1] antibody).~   "
21168|NCT03289949|"~     The investigators wish to investigate neurobiological effects of serotonin 2A receptor~     modulation in healthy volunteers, contrasting effects of an agonist (psilocybin) and an~     antagonist (ketanserin). Magnetic resonance imaging (MRI) and positron emission tomography~     (PET) will be used as neuroimaging tools.~   "
21169|NCT03289936|"~     Comparing the cardio-respiratory adaptation and differences to non invasive ventilation~     techniques, nasal intermittent positive pressure ventilation (NIPPV) non synchronized vs~     synchronized (sNIPPV) in preterm newborns (gestational age at birth < 32 weeks) at their~     first approach to non invasive ventilation.~   "
21170|NCT03289923|"~     Background:~      Repetitive transcranial magnetic stimulation (rTMS) is a treatment for depression. It~     stimulates the brain. Researchers want to see if using magnetic resonance imaging (MRI) scans~     helps locate the best area for rTMS in each person. They also want to find other ways to make~     it more effective.~      Objective:~      To study the effects of combining MRI- guided transcranial magnetic stimulation (TMS) and~     talk therapy on the brain in people with depression.~      Eligibility:~      Adults ages 18 65 with a major depressive disorder and current depression. If taking an~     antidepressant, should have been doing so for at least 4 weeks.~      Design:~      Participants will be screened with medical and psychiatric history, psychiatric evaluation,~     physical exam, and blood and urine tests.~      Phase 1 is 1 4 visits in 1 week. Participants will have:~      Brain MRI. Participants will lie on a table in a scanner.~      Questions about their medical history and psychology symptoms~      Tests of mood and thinking~      Tests of brain activity. Participants may do tasks during these tests:~      A cone with magnetic detectors is put on the head.~      A cap with electrodes is put on the scalp.~      TMS. A brief electrical current passes through a wire coil on the scalp.~      A metal disk will be placed on the arm. A nerve will be stimulated with a small electrical~     shock.~      Phase 2 is about 6 to 7 weeks.~      There will be 30 daily sessions of combined therapy and repetitive TMS (rTMS) for 6 weeks.~      Participants will receive rTMS and another therapy by computer.~      For rTMS, repeated pulses will pass through the coil.~      This is followed by up to 3 additional visits, when:~      Participants will repeat Phase 1 tests~      Participants will rate their depression symptoms.~      Phase 3 is 3 visits over 3 months. Participants will rate their depression symptoms and~     repeat some of the previous questionnaires and tests of mood and thinking.~   "
21171|NCT03289910|"~     This randomized phase II trial studies how well topotecan hydrochloride and carboplatin with~     or without veliparib work in treating patients with myeloproliferative disorders that have~     spread to other places in the body and usually cannot be cured or controlled with treatment,~     and acute myeloid leukemia or chronic myelomonocytic leukemia. Drugs used in chemotherapy,~     such as topotecan hydrochloride and carboplatin, work in different ways to stop the growth of~     cancer cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Veliparib may stop the growth of cancer cells by blocking some of the~     enzymes needed for cell growth. Giving topotecan hydrochloride, carboplatin, and veliparib~     may work better in treating patients with myeloproliferative disorders and acute myeloid~     leukemia or chronic myelomonocytic leukemia.~   "
21172|NCT03289897|"~     A multi-centre randomised controlled trial to determine the implementation and health care~     cost of LiverMultiScan vs. routine methodical assessment (standard care) of Non-alcoholic~     fatty liver disease (NAFLD) across several European countries.~   "
21173|NCT03289884|"~     Hydatid disease is a major healthcare problem worldwide caused by infection that commonly~     affects the liver. Treatments for hydatid disease depend on how advanced the disease is and~     if the infection is active or not. Currently, doctors decide what stage the disease is at by~     looking at the appearance of liver on scans and by performing blood tests. It is however~     still very difficult to be certain if a treatment is working and when is the right moment to~     start and stop medication. Magnetic Resonance Imaging (MRI) scanning is a safe and~     non-invasive way of imaging the liver that can provide detailed information not just about~     what the liver looks like but also other information about the chemical composition of normal~     and diseased liver tissue. MRI is already widely used in the NHS for many liver conditions~     but it is unknown whether analysing the chemical composition will help decide on the stage~     and activity of hydatid liver disease. This study will allow comparison between MRI~     information about liver structure and composition with existing methods of assessing disease~     stage. If fluid is later obtained from the liver as part of usual clinical care (either using~     a needle with ultrasound or at the time of surgery), this study will also compare information~     about the fluid composition obtained from MRI scanning, with the results obtained when~     analysing the fluid in the lab. This will help to develop a more accurate way of~     non-invasively assessing hydatid disease in the liver, in the future.~   "
21177|NCT03289832|"~     The objective is to determine, in a small number of participants, the protective effects of~     UV-induced skin erythema (reddening or sunburn) following oral administration of~     sulforaphane, curcumin, or a combination of the two plant (diet)-based supplements. The~     investigators will be using the over-the-counter nutritional supplements Crucera-SGS and~     Meriva-SF to deliver the biologically stable sulforaphane precursor and a highly bioavailable~     formulation of curcumin. Volunteers will be challenged with UV irradiation at 2-times the~     minimum erythematous dose (M.E.D.) on discrete 2 cm diameter circles on the upper buttocks.~     Skin redness will be monitored daily using a chromometer. Biomarkers will then be evaluated~     in blood, urine, and skin biopsies.~   "
21178|NCT03289819|"~     Despite its aggressiveness and high incidence, to date, no targeted therapies exist for the~     treatment of triple negative breast cancer (TNBC). Emerging evidence suggests a crucial role~     of tumor immunology on outcome for this entity. Checkpoint inhibitors like pembrolizumab,~     which target immune cells within the tumor, might therefore have an important impact on~     therapy response and outcome in these high risk patients. We propose a phase II study~     exploring pathological complete response and the safety of the combination of pembrolizumab~     and nab-paclitaxel as well as the combination of pembrolizumab with epirubicin and~     cyclophosphamide in the neoadjuvant setting for women with early TNBC. After completion of~     this study an extension will be determined.~   "
21179|NCT03289806|"~     Post-operative fibrosis of trabulectomy blebs is a major cause of surgical failure leading to~     a renewed increase in intraocular pressure. The use of anti-metabolites over many years has~     made it possible to improve success rates for this surgery but these drugs have numerous~     adverse effects as they are toxic. Alternative therapies are thus necessary, and we believe~     that DHA could have antifibrotic effects on fibroblasts and could thus improve success rates~     in this surgery.~   "
21180|NCT03289793|"~     This project aims to assess the evolution of symptoms in ADHD children from 8 to 17 years,~     with various types of attention training.~      Different groups A, B and C will be evaluated: the first with Neurofeedback training, the~     second with a similar training but not indexed on brain activity and the third without~     training.~      30 patients will be randomly assigned to groups A and B according to a ratio 2:1.~      Others patients who meet the same criteria but for logistical reasons cannot comply with the~     training constraints will be assigned to group C.~      Children included in groups A and B will participate in training sessions (Neurofeedback and~     control training, respectively) as well as in four evaluation sessions. Children in group C~     will only participate in evaluation sessions (baseline control group).~      Patients of groups A and B will be followed over 6 months: 4 months of training and a~     follow-up evaluation 2 months after training.~      Patients of group C will be followed each 2 months for 6 months. This study uses~     electro-encephalography measures, serious video game, neuropsychological tests and~     questionnaires.~      It also uses actigraphy measures to evaluate sleep quality.~   "
21181|NCT03289780|"~     The purpose of this study is to collect information about how a doctor uses the results of~     the VeriStrat® blood test to guide treatment for non-small cell lung cancer (NSCLC) patients.~     Understanding how VeriStrat test results influence doctors' decisions and patients' outcomes~     may help doctors to better treat NSCLC in the future. This study will also look to establish~     whether new investigational tests can help better predict the effectiveness of certain~     medications for certain patients. These new investigational tests are only for research~     purposes at this time.~   "
21182|NCT03289767|"~     To observe the effect of additional E-tube angulation on intubation time and success rate.~   "
21183|NCT03289754|"~     This study is designed to evaluate the clinical outcomes of subjects who have recently~     undergone surgery with the iTotal® Cruciate Retaining (CR) Total Knee Replacement System~     (KRS) who have also had iPoly XE Tibial Inserts implanted.~   "
21184|NCT03289741|"~     This study is being done to evaluate differences in patient experience during treatment with~     octreotide LAR and lanreotide.~   "
21185|NCT03289728|"~     The WHO predicts that cardiovascular morbi-mortality will increase by 120-137% within 20~     years due to the aging population. Myocardial infarction without ST segment elevation~     (NSTEMI) is the most common form of infarction. However, its treatment among elderly patients~     remains a challenging question.~      Indeed, the risk benefit balance of revascularization remains unclear, and complications~     related to revascularization are more frequent in the elderly, including MI, heart failure,~     stroke, renal failure and bleeding according to National Cardiovascular Network data.The last~     randomized controlled trial After Eighty Study, showed a reduction of major~     cardio-cerebrovascular events (MACCEs) in NSTEMI patients with an invasive strategy~     (systematic coronary angiography - CA) compared to a conservative strategy (medical treatment~     alone). Nevertheless, this study presented several limitations of which a major one was the~     lack of a definition of frailty at inclusion. Moreover, the After Eighty Study has shown~     that percutaneous revascularization in the invasive arm was only performed for 1 in 2~     patients showing an inadequacy in the strategy for selecting candidates for~     revascularization.~      Consequently, despite European Society of Cardiology (ESC) guidelines, the management of~     NSTEMI in elderly patients is not yet evidence based, and current recommendations do not~     provide any clear clinical decision rule indicating one strategy over another.~      For fragile patients, an alternative strategy consists of selecting candidates for a guided~     CA according to the extent of myocardial ischemia, identified by non-invasive imaging.~     Single-photon emission computed tomography or dobutamine stress echocardiograms are currently~     the reference methods with well-defined interpretation of ischemia. According to our~     experience, this strategy avoids CA for one third of patients and improves the rate of~     revascularization.~      The aim of our study is to compare 1-year morbidity and mortality in NSTEMI patients over 80~     years, assigned to guided versus systematic-CA. Our hypothesis is that the guided strategy~     will not be inferior on MACE rates at 1 year, and will be cost-effective by reducing~     iatrogenic complications.~   "
21186|NCT03289715|"~     Monocenter study to determine and evaluate the optimal amount of humidification doses~     delivered by the On-Demand humidification system in neuromuscular patients requiring home~     mechanical ventilation. The patient's perception will be monitored with subjective as well as~     with objective measurements of the optimum comfortable on-demand humidification doses.~   "
21187|NCT03289702|"~     The purpose of this study is to evaluate the efficacy and safety of CORETOX® in the treatment~     of Post stroke upper limb spasticity~   "
21250|NCT03288883|"~     The aim of the current study is to assess whether the CO2-laser results in superior~     alleviation of GSM symptoms compare to Er:YAG-laser. Specifically, we will compare objective~     and subjective measurements of symptoms and clinical signs of GSM, between groups of~     postmenopausal women with GSM receiving treatment with CO2-laser or Er:YAG-laser.~   "
21251|NCT03288870|"~     International multi-center open-label randomized clinical trial of efficacy, safety and~     pharmacokinetics of BCD-100 (JSC BIOCAD, Russia) monotherapy compared to docetaxel as~     second-line therapy of patients with advanced inoperable or metastatic non-small cell lung~     cancer~   "
21188|NCT03289689|"~     Purpose: To evaluate the short-term effects of whole-body vibration (WBV), using~     reciprocating plate technique, on manual ability performance in healthy younger.~      Material and methods: 38 healthy young volunteers were randomized to WBV group (N=19; 6 men,~     13 women; mean age 21, 3.8yrs) or control group (N=19; 6 men, 13 women; mean age 20.5,~     3.5yrs). The subjects in the WBV group performed one series of five consecutive repetitions~     of 60 sec unsynchronised WBV (Zeptoring, Scisen GmbH, Germany; 4 Hz, amplitude 3mm) with a~     1-min pause between administrations, three times a week. The controls did not receive any~     training. Both groups were evaluated at baseline and after intervention, in the Rey Juan~     Carlos University´s Gait Analysis Laboratory. Four outcome measures of Purdue Pegboard test~     (PPT): preferred hand (PH), non-preferred hand (NPH), both hands (BH) and assembly (A) was~     performed baseline and 5 min after intervention.~   "
21189|NCT03289676|"~     HIV has transformed into a chronic illness due to the advent of effective treatments in the~     absence of a cure. As a result, the prevalence of non-AIDS defining cancers (NADCs),~     including lung cancer, has increased three-fold among people living with HIV. NADCs now~     account for 50% of all cancers among the people. Smoking is one of the major contributing~     factors to lung cancer and smoking prevalence is substantially higher in this population than~     the general U.S. population. Smoking prevalence does not differ by gender among people living~     with HIV. Women of color, particularly African American women represent the majority of women~     living with HIV (WLHIV) followed by Latinas. WLHIV smoke at a rate almost 3 times higher than~     that for the general U.S. female population (e.g., 42% vs. 16%). The proposed study has two~     phases: 1) the development of a storytelling narrative communication (SNC) intervention that~     will be added to an established HIV-tailored smoking cessation intervention and 2) a two-arm~     randomized controlled trial (RCT) of the HIV-tailored intervention plus the SNC Intervention~     compared with the HIV-tailored intervention only. The investigators will develop narrative~     videos with three to five WLHIV who will be talking about their personal struggles with~     smoking and success in quitting. Preliminary study revealed that the established HIV-tailored~     intervention was effective only for short-term (≤ 2 months) abstinence. Many relapsed to~     smoking between the 2nd and 6th month of quitting. The investigators propose that the SNC~     intervention will be an effective strategy to sustain their quit efforts for long-term~     abstinence (≥ 6 months). A total of 60 WLHIV will be recruited and randomly assigned to~     either the experimental arm (a combination of HIV-tailored and SNC interventions) or the~     control arm (HIV-tailored intervention only). Specific aims of the study are to 1) Identify~     SNC intervention components that are rated high in transport and identification for use as an~     enhancement to an HIV-tailored smoking cessation intervention; 2) Determine the feasibility~     and acceptability of the SNC intervention for WLHIV by assessing the rate of recruitment and~     retention for feasibility and the degree of transport and identification for acceptability;~     and 3) Establish an effect size of HIV-tailored and SNC interventions for smoking cessation~     in comparison with the HIV-tailored smoking cessation intervention only for WLHIV, for~     subsequent grant applications.~   "
21190|NCT03289663|"~     Despite the mass distribution of LLINs (long-lasting insecticidal nets) as a Malaria control~     strategy, populations are still continuously exposed to a high frequency of malarial~     inoculation in some countries. The situation can be explained by a swift increase in the~     resistance of Anopheles to common insecticides. To preserve the gains of insecticides and~     improve their effectiveness, a new generation of bednets treated with piperonyl butoxide~     combination insectides have emerged.But more evidence is needed to plead for scale up of~     their usage. The lack of information relating to the additional impact of that combination on~     the transmission of Malaria, its relative efficacy in real-life setting and its safety in~     users are the rationale for more investigation.This will be a randomized controlled study on~     a dynamic cohort of households with 1680, 0-10 years-old subjects in 30 villages will be~     recruited to compute the effectiveness of this new tool.~      The findings will be useful information for decision-making by national malaria control~     programs, their partners, the international community and the bednet manufacturers with~     regard to the effectiveness of the new combination of insecticides in real-life context. The~     results will also enable a better design of the tool in the future and a broader~     understanding of long-term dynamics for sustainability, as well as identification of some~     factors with negative impacts on the benefits of the strategy.~   "
21191|NCT03289650|"~     The overall aim of the study is to prospectively investigate the impact of two maintenance~     calcineurin inhibitor immunosuppressive regimens: once-daily extended release tacrolimus and~     twice-daily tacrolimus on subpopulations of T and B cells and alloreactive T cells as well as~     on renal allograft function.~   "
21192|NCT03289637|"~     In 200 patients with documented systolic heart failure give supplementation with vitamin D in~     those with a 25-OH- vitamin D < 50nmol/L - or placebo.~      In those with a vitamin D level <25nmol/L a substitution of 2400IU will be given, and in~     those with a vitamin D level 25-50nmol/L a substitution of 1600IU will be given.~      Intervention time 12 months. Biomarkers of heart function, quality of life, and~     hospitalisation will be analysed.~   "
21193|NCT03289624|"~     SHARE-CC is an intervention for families facing the challenges of chronic conditions.~     SHARE-CC (Support, Help, Activities, Resources, and Education) addresses the need for both~     members of a care dyad to be actively involved in current and future care planning. This~     intervention aims to increase knowledge of services, improve communication skills and~     well-being, and facilitate the understanding of care values and preferences in order to~     create a mutually agreed upon care plan. This intervention will be tested in a randomized~     control trial.~   "
21194|NCT03289611|"~     The aim of the PRECOG study is to determine in a prospective interventional randomized study~     whether the implementation of a predictive test based on the sFLT-1/PlGF ratio improves~     perinatal care and reduces costs, in patients with suspected preeclampsia before 35 weeks of~     gestation.~   "
21195|NCT03289598|"~     Community-dwelling older adults receiving support at home such as meals-on-wheels may lose~     the ability to preserve social, cognitive, and functional abilities, when becoming accustomed~     to and dependent of community aged care. When still able to cook older adults often hold some~     control over the foods that are prepared and which they eat, and which helps to foster~     identity. The purpose of this study is to evaluate community-dwelling older adults being~     involved in activities in relation to meals in a rehabilitation program.~   "
21196|NCT03289585|"~     The goal of this study is to get a better understanding of the skin condition, Hidradenitis~     Suppurativa, and to find out how the disease affects quality of life. The investigators hope~     this information will help improve treatment for this skin condition.~   "
21197|NCT03289572|"~     Neurologic disease with loss of motor function is a major health burden. Brain-computer~     interfaces (BCI) are systems that use brain signals to power an external device, such as a~     communication board or a prosthetic device, which may help people with loss of motor~     function. Electrocorticography (ECoG) has been used to decode hand movements and as a control~     signal for brain-computer interface (BCI). This study hopes to use a smaller spacing of ECoG~     to see if a better motor signal can be found and used as a BCI control signal.~   "
24790|NCT03242525|"~     The aim of the present study is to quantify the time advantage achieved by the use of POCT~     compared to conventional coagulation diagnostics. A further objective of this study is an~     analysis of the result quality of POCT for the prothrombin time / international normalized~     ratio.~   "
21198|NCT03289559|"~     Evidence is accumulating that there are sex differences in energy and substrate metabolism.~     The positive or negative consequences of such metabolic differences between men and women~     need to be evaluated with respect to health outcomes. The importance of aberrant lipid~     metabolism in metabolic diseases such as obesity, diabetes and cardiovascular disease, makes~     understanding the distinction between normal vs aberrant critical to future treatment and~     prevention strategies. Sex differences in the effects of catecholamines on lipid metabolism~     and substrate oxidation in non-obese, healthy individuals, have been consistently observed.~     In addition, distinct differences in men and women exist in the distribution of body fat,~     with men typically having greater central adiposity than women. Accumulation of fat in the~     abdomen is associated with an increased risk for metabolic abnormalities such as~     hyperlipidemia and insulin resistance. In the current study, therefore, the role of~     testosterone in determining the sex differences in catecholamine mediated substrate~     metabolism and deposition of dietary fat into upper versus lower body adipose tissue depots~     will be addressed.~   "
21199|NCT03289546|"~     The purpose of this study is to explore whether physical exercise, mindfulness training, or~     both interventions together can improve cognitive function in individuals with multiple risk~     factors for the development of dementia in the future.~   "
21200|NCT03289533|"~     To evaluate the safety, efficacy and PK of avelumab in combination with axitinib as first~     line treatment in patients with advanced HCC~   "
21201|NCT03289520|"~     The objective of the study is to determine whether clopidogrel reduces the early failure rate~     of native AV fistulae. This study was originally registered as NCT00067119 which included two~     protocols, this one and the GRAFT study)~   "
21202|NCT03289507|"~     The primary objective of the study is to characterize the curcumin metabolites of 2 different~     capsule formulations of curcumin relative to unformulated Curcuma longa extract of Rhizomes~     including assessing relative bioavailability and absorption/kinetic profile of curcumonoids~     and their metabolites in human plasma and urine after acute consumption.~   "
21203|NCT03289494|"~     The study is a randomized pilot study. The research hypothesis is that the diet high in SDS~     content (H-SDS) will lower the daylong glycemic response and improve the glycemic control in~     patients with type 2 diabetes (T2D) compared to the diet low in SDS content (L-SDS).~   "
21204|NCT03289481|"~     The objective of this project is to determine if Neo40, a nitric oxide generating lozenge,~     when consumed twice daily by subjects with HFpEF, will increase exercise tolerance, decrease~     symptoms and improve quality of life for patients.~   "
21205|NCT03289468|"~     The postmenopausal women with vaginal bleeding were selected in this cross-sectional study.~     The basic characteristics information and endometrial blood flow energy index of endometrium~     were detected by color power Doppler ultrasound, and the energy histogram of endometrium was~     obtained. The specimen of uterine cytology and endometrial tissue were obtained through~     minimally invasive endometrium sampler, which were diagnosed by pathology. The statistical~     data were used to detect endometrial and precancerous lesions to observe the endpoint, and to~     provide the energy histogram model of the early warning endothelial diseases.~   "
21206|NCT03289455|"~     The purpose of this study is to test the safety and efficacy of AUTO3, a CAR T cell treatment~     targeting CD19 and CD22 in paediatric or young adult patients with relapsed or refractory B~     cell acute lymphoblastic leukaemia.~   "
21207|NCT03289442|"~     The purpose of this study is to determine whether the supine position is better than the left~     lateral horizontal body position to decrease cecal intubation time, patients' pain and the~     difficulty of colonoscopy insertion.~   "
21208|NCT03289429|"~     This study aims to compare the antiarrhythmic and cardioprotective effects of Atorvastatin~     versus Magnesium Sulfate after Cardiac valve Replacement Surgery~   "
21209|NCT03289416|"~     This study is intended to compare whether bone marrow aspirate concentrate or platelet rich~     plasma injections is more effective in treating knee osteoarthritis.~   "
21210|NCT03289403|"~     The aim of the work is to determine whether the use of immunomodulatory drugs could improve~     the reproductive of outcome of infertile patients who have autoimmune thyroiditis with~     positive autoimmune antibodies undergoing IVF-ET.~   "
21211|NCT03289390|"~     This study will evaluate the use of acetaminophen in preterm infants when a patent ductus~     arteriosus (PDA) is of concern. We will perform two simultaneous prospective observational~     studies over a 3 year period. The first will be of infants with clinically significant PDAs~     beyond 14 days of life who are medically treated with acetaminophen as a means to avoid~     surgical ligation, and the second will be of infants who received acetaminophen for a PDA~     closure during the first 2 weeks of life as a result of ibuprofen, the current standard of~     care in our NICU, contraindication due to medical status.~   "
21212|NCT03289377|"~     An multi-stage mixed-method design will be employed to obtain both qualitative and~     quantitative data to address two study aims: (1) Evaluate and refine the delivery Reducing~     Disabilities in Alzheimer's Disease (RD- AD) training to advanced practice nurses and (2)~     Evaluate and refine the implementation of RD-AD by advanced practice nurses in their medical~     settings.~   "
21213|NCT03289364|"~     The goal of this study is to estimate the efficacy of Penguin cold caps in preventing or~     reducing hair loss in patients receiving (neo)adjuvant chemotherapy (one of four common~     regimens) for early stage breast cancer.~   "
21214|NCT03289351|"~     After appendix has been removed for perforated appendicitis, patients will receive~     postoperative antibiotics. In the last 5 years, the literature has transitioned from a 3~     -drug therapy to 2-drug therapy. Now there is a recent literature suggesting a single-drug~     therapy may be safe and adequate. In fact, using zosyn (piperacillin-tazobactam) as a~     single-drug therapy, there are additional benefits of simplicity, compliance, and lower~     infectious complications. Currently surgeons are already using both 2-drug regimen~     (ceftriaxone/metronidazole) and single-drug regimen (zosyn) interchangeable as both are FDA~     approved antibiotics for intra-abdominal infection. There is a clear need to compare outcomes~     between these two options.~   "
21272|NCT03288597|"~     68Ga-DOTANOC and 18F-FDG PET/CT have important values in the staging and clinical treatment~     of neuroendocrine tumors. Retrospective studies suggest that the positivite rates and SUVmax~     of dual imaging associated with pathological findings and prognosis. The study was designed~     to confirm thet clinical values of dual imagings for neuroendocrine tumors.~   "
21215|NCT03289338|"~     Charcot neuropathic osteoarthropathy (CNO) is a progressively destructive process resulting~     from significant peripheral neuropathy of almost any aetiology. Diabetes mellitus has emerged~     as the commonest cause of CNO.~      The Charcot foot in diabetes poses many clinical challenges in its diagnosis and management.~     The lacuna primarily lies in delineation of its etio-pathogenesis and consequently in~     targeted treatment modalities. Although traditional approaches focus on neurotraumatic and~     neurovascular theories, these fail to explain all the features of CNO, hence, other~     hypotheses have been put forward.The current belief is that once the disease is triggered in~     a susceptible individual, it is mediated through a process of uncontrolled inflammation~     which, in turn, leads to osteolysis, fractures and joint destruction. Of these processes, the~     involvement of the receptor activator of nuclear factor- кB (RANK) ligand~     /RANK/osteoprotegerin (OPG) system in the process of acute CNO is particularly appealing and~     suggests new pharmacological approaches.~      Standard modalities of treatment include offloading and casting. Although various trials have~     analysed the impact of medical agents including bisphosphonates, teriparatide and bone~     stimulation techniques, the results have been either inconclusive or not translated into~     clinical practice. Hence, there is no efficacious treatment of active CNO apart from the~     traditional offloading. In view of recent advances in understanding of the disease process,~     the target of intervention should, logically, be interruption of the inflammatory cascade and~     subsequent osteoclast resorption. Zoledronic acid is the most potent bisphosphonate that has~     been studied in clinical trials to date and has the distinctive profile of strong inhibitory~     activity on the enzyme farnesyl pyrophosphate synthase, essential for osteoclast function.~     Methylprednisolone conceivably has a potential benefit by offsetting the RANKL/OPG system~     involved. There have been conflicting reports with bisphophosphonates in active CNO and~     Zoledronic acid has been infrequently used despite being the most potent. Glucocorticoids~     including methylprednisolone have also not been systematically tried in this condition.~      We hypothesise that targeting the inflammatory cascade with Methylprednisolone and osteoclast~     mediated damage by Zoledronic acid will address the basic etiopathogenesis of active CNO and~     may result in earlier resolution of the disease activity. The above mentioned hypothesis is~     hence, planned to be tested in a randomised, double-blind, placebo-controlled study.~   "
21216|NCT03289325|"~     A retrospective study showed that intraoperative dexmedetomidine administration was~     associated with decreased risk of 1-year mortality after cardiac surgery. In a previous~     randomized controlled trial, 285 elderly patients undergoing cardiac surgery were randomized~     to receive either perioperative dexmedetomidine or placebo (normal saline) administration.~     The purpose of this 2-year follow-up study is to investigate whether perioperative~     dexmedetomidine can improve long-term outcomes in those recruited elderly patients after~     cardiac surgery.~   "
21217|NCT03289312|"~     There is an observational, clinical study. We recruit sepsis patients to investigate what~     drives peripheral lymphocyte loss in sepsis.~   "
21218|NCT03289299|"~     This study evaluates the use of carfilzomib, lenalidomide, daratumumab, and dexamethasone in~     subjects with high-risk smoldering multiple myeloma (SMM). Subjects will receive treatment in~     3 phases - induction (6 cycles), consolidation (6 cycles), and maintenance (12 cycles). Each~     cycle is 28 days.~   "
21219|NCT03289286|"~     This is a monocentric, prospective cohort study evaluating the feasibility of a perioperative~     e-follow-up protocol in patients with ambulatory surgery for breast cancer.~      This protocol will be based on:~        -  A coordinated ambulatory follow-up performed by a dedicated nurse~        -  An electronic follow-up tool used in pre- and post-surgery~      Patients will be followed 8 days before the surgery until 30 days after the surgery of breast~     cancer.~   "
21220|NCT03289273|"~     Observational study to evaluate, under real-world practice conditions, the safety and~     effectiveness of regorafenib in patients diagnosed with unresectable hepatocellular carcinoma~     (uHCC)~   "
21221|NCT03289260|"~     AdAM is a prospective, randomized, controlled, double-blinded, monocentric trial in patients~     receiving surgical therapy due to anal HPV infection.~      Aim of the study is to evaluate efficacy of combination therapy (surgical therapy + topical~     Imiquimod-therapy). It is planned to include 200 patients.~      100 patients receive surgical therapy+ topical Imiquimod therapy, 100 patients receive~     surgical therapy + topical Placebo therapy~   "
21222|NCT03289247|"~     The study's primary objective is to compare the following parameters between wound closure~     following primary TKA with and without supplement tissue adhesive (Leukosan®):~   "
21223|NCT03289234|"~     To assess the pharmacokinetics of MCI-186 after a single intravenous infusion of 30mg/hour in~     subjects with mild or moderate Hepatic impairment compared to subjects with normal hepatic~     function~   "
21224|NCT03289221|"~     Investigate the presence of hypotonic anal sphincter after anorectal dilatation and~     High-Intensity Focused Ultrasound (HiFU) , through the aplication of questionnaires and~     Anorectal Manometry before and after this treatment.~   "
21225|NCT03289208|"~     To assess the pharmacokinetics of MCI-186 after a single intravenous infusion of 30mg/hour in~     subjects with mild or moderate renal impairment compared to subjects with normal renal~     function.~   "
21226|NCT03289195|"~     The purpose of this study is to test the ability of a breast MRI biopsy to accurately~     diagnose a complete tumor response to the neoadjuvant chemotherapy (NAC) that the patient~     just finished. Numerous studies have shown that MRI has the highest accuracy for diagnosing a~     complete tumor response. The investigator wants to see if in a certain group of women who's~     breast cancer is no longer visible on the post-treatment MRI that the biopsy specimens from a~     MRI guided biopsy will accurately diagnose a complete tumor response to treatment which may~     in the future make breast surgery unnecessary in some women.~   "
21227|NCT03289182|"~     This is a prospective, multicenter, non-interventional study to test the safety and~     effectiveness of MabThera administered subcutaneously in participants with NHL or CLL. The~     length of study is expected to be 6 years.~   "
21228|NCT03289169|"~     This study evaluate the long-term safety of repeated administraions of meditoxin® in the~     treatment of moderate to severe glabellar lines.~   "
21229|NCT03289156|"~     The purpose of this study is to examine whether changes in psychological and physiological~     responses differ based on different strategies for responding to stress.~   "
21230|NCT03289143|"~     This is a phase II, randomized, placebo-controlled, double-blind study to evaluate the~     efficacy and safety of RO7105705 in participants with prodromal to mild Alzheimer's disease.~     An optional 96-week open-label extension period will be available to participants who~     complete the double-blind treatment period and who, in the judgment of the investigator,~     would potentially benefit from open-label RO7105705 treatment.~   "
21231|NCT03289130|"~     The North Carolina-Louisiana Prostate Cancer Project is a population-based case-only study of~     over 2,000 men newly diagnosed with prostate cancer designed to address racial differences in~     prostate cancer aggressiveness and survival through a comprehensive evaluation of social,~     individual, and tumor level influences on prostate cancer aggressiveness. Project 3~     specifically aims to examine nutritional modulation of prostate cancer aggressiveness using~     dietary assessment and biomarker-based data on dietary factors.~   "
21234|NCT03289091|"~     The aim of the study is to investigate the effects of two water based aerobic training~     programs on cardiorespiratory, neuromuscular and quality of life parameters in old women.~      Volunteer old women age range: 60-75 years old, will participate to this study, and will~     randomly divided into two groups: continuous aerobic training group and interval aerobic~     training group.~      Both group subjects will participate in two-week training sessions during 12 weeks.~     Independent of the group, participants will perform three water-based exercises: stationary~     running, frontal kick and cross-country skiing. The intensity of aerobic exercise will be~     based Rating Perceived Exertion (RPE). Along the training, the intensity of aerobic exercise~     will increase in both groups. Before and after intervention, there will be evaluation of~     muscle quality, muscle thickness, peak oxygen uptake and oxygen uptake at ventilatory~     threshold, maximal isometric and dynamic strength of knee extensors, maximal and submaximal~     isometric eletromiografy (EMG) activity of vastus lateralis and rectus femoris, muscle~     endurance, performance in functional tests and assessment of the perception of quality of~     life.~      Data will be analyzed by Generalized Estimating Equations (GEE) and Bonferroni's post-hoc~     test (α=0.05), including both protocol and intention to treat analyses (α=0,05).~   "
21235|NCT03289078|"~     Evaluation of functional improvement after spa therapy in Fontcaude center, for knee~     osteoarthritis Background. Knee osteoarthritis is the first indication of spa therapy in~     rheumatology. This therapeutic represents a non pharmacological treatment and is recommended~     by OARSI.~      In order to obtain agreement for spa therapy, the center Fontcaude, needs to show clinical~     improvement for patients, as demonstrated in the Thermarthrose study. This center is near~     Montpellier and could improve patients localised in this area.~   "
21236|NCT03289065|"~     The purpose of this study is to collect data that will increase understanding of Fabry~     disease history and progression, in treated and untreated patients with Fabry disease. The~     data from FOS may provide guidance to healthcare professionals about disease treatment~     options.~   "
21237|NCT03289052|"~     This is a randomized, evaluator-blinded, no-treatment controlled study in subjects with~     Midface Volume Deficit and/or Midface Contour Deficiency.~   "
21238|NCT03289039|"~     This research study is studying a drug called Neratinib with and without Fulvestrant as~     possible treatments for HER2-positive breast cancer .~      The interventions involved in this study are:~        -  Neratinib and Fulvestrant~        -  Neratinib alone~   "
21239|NCT03289026|"~     This study attempts to observe the effectiveness and safety of aripiprazole in hospitalized~     patients with acute schizophrenia episode, and to compare the different drug regimens that~     may be involved in order to clarify the characteristics of the population for taking~     aripiprazole and provide reference for clinical rational drug use.~   "
21240|NCT03289013|"~     This study investigates the adhesion of new adhesives to the skin.~   "
21241|NCT03289000|"~     This study is a retrospective, multi-center study, with one single remote follow up contact.~     This study will include a minimum of 80 patients and a maximum 100 patients who have been~     treated with the ConforMIS iTotal PS knee product.~   "
21242|NCT03288987|"~     This is a Phase III, randomized, two arms, double-blind (patient and assessor blinded),~     parallel active non inferiority controlled clinical trial with a 2:1 allocation. This trial~     was conducted to evaluate the efficacy and safety of bevacizumab (produced by AryoGen~     Pharmed) plus FOLFIRI-3 compared with bevacizumab (Avastin®) plus FOLFIRI-3 in patients with~     metastatic colorectal cancer (mCRC). Patients who met the following criteria could be~     recruited to receive the mentioned intervention randomly. Inclusion criteria: male or female~     aged 18-75 years, mCRC verified histologically, Having one or more bi-dimensionally~     measurable lesions as defined by Response Evaluation Criteria In Solid Tumors (RECIST)~     criteria, Was not felt to be amenable to curative resection, With an (ECOG) performance~     status of ≤ 1, Life expectancy of longer than 3 months, Adequate organ and marrow function,~     May have received adjuvant therapy for primary colorectal cancer provided that at least 6~     months have elapsed from the time the adjuvant therapy was concluded and recurrent disease~     was documented, Patients with history of hypertension must be well-controlled (blood pressure~     less than/equal to 150/100), on a stable regimen of anti-hypertensive therapy.~   "
21243|NCT03288974|"~     PMS period: 09Jun2017 ~ 08Jun2023 Target no.: 600patients~      indication: POMALYST in combination with dexamethasone is indicated in the treatment of~     patients with relapsed and refractory multiple myeloma who have received at least two prior~     treatment regimens, including both lenalidomide and bortezomib~      The primary objective of this Drug Use Examination (DUE) is to evaluate safety of POMALYST®~     (Pomalidomide) treatment of multiple myeloma in the clinical routine practice in Korea.~      The secondary objective of this DUE is to evaluate effectiveness of POMALYST® (Pomalidomide)~     treatment of multiple myeloma in the clinical routine practice in Korea.~   "
21244|NCT03288961|"~     This study aims to develop a self-screening tool for Crohn's perianal fistula.~   "
21245|NCT03288948|"~     To evaluate the effectiveness of enhanced binocular amblyopia treatments in achieving a more~     complete and stable recovery.~   "
21246|NCT03288935|"~     The main purpose of this study is to evaluate early-phase interventions for refugee wellness~     promotion and build evidence for dissemination of the intervention model and curricula~     through refugee resettlement programs, local and national.~   "
21247|NCT03288922|"~     High-efficiency post-dilution online hemodiafiltration (OL-HDF) using high-flux dialyzer and~     requiring high blood flow rate (BF ≥400 mL/min) has been reported to enhance protein-bound~     toxin and middle molecular toxin removal and improve patient survival. Unfortunately, the~     majority of patients could not reach that high BF because of vascular access issue. This~     randomized crossover study was conducted to compare these uremic toxin removals between the~     new modality (limited BF OL-HDF with super high-flux dialyzer) and the control~     (high-efficiency OL-HDF). The OL-HDF patients were randomized to undergo either new modality~     or control for 2 weeks before crossover to the other modality for another 2 weeks.~   "
21248|NCT03288909|"~     This is a prospective observational study investigating the utility of 7 Tesla MRI to~     quantify nigrosome1 signal in a cohort of individuals with recent onset Parkinson's disease~     and in at-risk cohorts at a premotor state of Parkinson's disease.~   "
26965|NCT03214029|"~     Compare the analytical and clinical performance of hs-cTnI and hs-cTnT assays for the~     diagnosis of acute myocardial injury and myocardial infarction in patients presenting to the~     emergency department in whom serial cTnI measurements are obtained on clinical indication.~   "
21252|NCT03288857|"~     The investigators aim to compare the standard bulb aspirator with that of a nasal oral~     aspirator. The hypothesis is that use of a nasal oral aspirator is more effective at removing~     nasal secretions in the treatment of bronchiolitis as measured by a predicted 50% decrease in~     the rate of unscheduled bronchiolitis return visits. The primary endpoint will be the number~     of unscheduled bronchiolitis return visits; secondary endpoints will include measurements of~     oral intake, respiratory relief, parental device preference and adverse events.~   "
21253|NCT03288844|"~     This is a multinational, multicentre, prospective, non-pharmacological follow-up study of the~     clinical trial HOLOCORE. All patients transplanted with Holoclar in the HOLOCORE clinical~     trial who consent to participate will be enrolled in this prospective study and observed for~     at least 12 months.~   "
21254|NCT03288831|"~     This study evaluates why people with celiac disease and non-celiac gluten/wheat sensitivity~     develop rapid onset symptoms within hours of gluten exposure. Half of subjects will be given~     gluten and half will not.~   "
21255|NCT03288818|"~     This phase II trial studies how well low dose total skin electron beam radiation therapy and~     mechlorethamine hydrochloride gel work in treating patients with mycosis fungoides. Total~     skin electron beam radiation therapy uses high energy x-rays directed at the entire surface~     of the body to kill cancer cells and shrink tumors. Mechlorethamine hydrochloride gel may~     help patients in remission of disease, reduction in disease staging, and enhanced quality of~     life. Giving total skin electron beam radiation therapy and mechlorethamine hydrochloride gel~     may work better in treating patients with mycosis fungoides.~   "
21256|NCT03288805|"~     Healthy Chinese residents from South China will be recruited and followed up for at least 4~     years to evaluate the association between climate, diet and lifestyle and risks for the~     development of chronic diseases. Physical examination, questionnaire survey and biological~     sample collection will be conducted at baseline and the incidence of chronic diseases will be~     investigated during follow-up.~   "
21257|NCT03288792|"~     The purpose of this image acquisition study is to compare, in a Reader Study, the RI8 system~     used in conjunction with a conventional mammography to mammography alone, and to determine~     whether the addition of supplementary RI8 result will improve ROC area under the curve. The~     study is prospective, multi-center, sequential, control trial with the woman serving as her~     own control. Women determined to have heterogeneously or extremely dense breast based on her~     previous mammogram and are undergoing routine screening mammography at one of the clinical~     sites assigned for this study will be eligible to join the study.~   "
21258|NCT03288779|"~     Purpose and objective Schizophrenia is a chronic debilitating illness with cognitive deficits~     that cause serious impairment in psychosocial recovery and with few treatments to remediate~     these deficits. One area that holds great promise for the development of novel, effective~     therapies is noninvasive brain stimulation. The investigators have used one form of brain~     stimulation, transcranial magnetic stimulation (TMS), for some time to modulate and enhance~     cognitive function in the brain, especially working memory (WM) function, which has a central~     role in most executive processing that occurs in the brain. Theta burst stimulation (TBS) is~     a paradigm of TMS which has been shown to effectively modulate WM. Moreover, TBS can modulate~     gamma neural oscillations in the brain and neural activity, both of which have been~     implicated in the physiology of WM and pathophysiology of the disease process in~     schizophrenia, making these measures highly valuable for assessing physiological effects of~     TBS on cognition, quality of life and cortical inhibition. The purpose of this study is to~     evaluate the effect of TBS on WM in patients with schizophrenia, to develop evidence for~     potential brain stimulation techniques to treat cognitive deficits in schizophrenia.~      Study activities and population group: Study subjects will be inpatient schizophrenic~     individuals with minimal positive symptoms and predominant cognitive deficits at Duke~     University Hospital. In an initial session they will be screened and taught a WM task.~     Following this, one TBS session will follow in which TBS will target dorsolateral prefrontal~     cortex. They will perform the WM task before, with and after the TBS, with an expected~     pre-post enhancement of WM performance.~      Implications - There is a great need for treatments for cognitive deficits in schizophrenia.~     The results of this study will serve to generate pilot data for a much larger grant to~     develop a TBS therapy for remediating such cognitive deficits.~   "
21259|NCT03288766|"~     This study is a single-arm, prospective, multi-center study to assess clinical performance of~     the SHERLOCK 3CG™ Diamond Tip Confirmation System (TCS) with MODUS II software for confirming~     correct tip position of peripherally inserted central catheters (PICCs) in adult subjects~     with altered cardiac rhythm.~   "
21260|NCT03288753|"~     The present study aims to evaluate patient satisfaction and audiological performance with~     their current cochlear implant speech processor, the Neuro 1, and to compare it with the~     satisfaction and performance obtained with the new speech processor, the Neuro 2.~   "
21261|NCT03288740|"~     The main purpose of the trial is to assess the pharmacokinetics of semaglutide (i.e. the way~     the drug is distributed in the body over a period of time) following once-weekly~     administration of semaglutide in healthy Chinese subjects. Different dose levels (0.5 and 1.0~     mg) will be investigated in this trial. Participants will be administered semaglutide or~     placebo once-weekly by subcutaneous injection (under the skin fold of the abdominal wall)~     using a pen injector with a very small, thin needle by the trial doctor at the trial site for~     13 weeks. The trial consists of 23 visits in total, including visit for screening and safety~     tests, visit for dose administration and blood sample collection. The total time of~     participation will be approximately 18-22 weeks depending on participant's individual visit~     schedule.~   "
21262|NCT03288727|"~     High-throughput whole-genome sequencing (WGS) is bringing new opportunities in the diagnosis~     of rare diseases. It will more frequently lead to a primary diagnosis (aim of the genetic~     consultation), but it may also lead to the discovery of mutations not related to the~     patient's disease. These findings are called incidental findings (IF) and may give rise to~     preventive or curative interventions in a personalised medicine approach.~      The question of proposing to patients access to all or part of these findings is a matter of~     debate in France and elsewhere. This question has given rise to new challenges and new needs~     that professionals must respond to by implementing appropriate management and new skills. It~     raises specific ethical issues, which require precise understanding of the expectations and~     experiences of patients. Patients' diagnostic trajectories must also meet criteria for~     efficacy and financial and organisational sustainability for the healthcare establishments~     and, for the healthcare system. Our project aims to assess the expectations of~     patients/parents with regard to this opportunity, and to determine how information should be~     provided to patients and how they should be accompanied to ensure efficient and appropriate~     management.~   "
21273|NCT03288584|"~     Recent studies show beneficial effect of the inhibition of interleukin-6 (IL-6) activity on~     vascular and left ventricular (LV) function. The purpose of this study is to investigate~     whether anakinra, an IL-6 receptor antagonist, improves vascular, endothelial and LV function~     in patients with rheumatoid arthritis (RA).~   "
21263|NCT03288714|"~     This is a double-blind, sham controlled, multi-center study to confirm the safety and~     efficacy of synchronized transcranial magnetic stimulation (sTMS) for the treatment of~     patients currently experiencing an episode of depression who have failed to respond to at~     least one (1) antidepressant medication. Patients will be randomly assigned to either active~     or sham therapy and will undergo daily treatments for a period of time. Following completion~     of blinded treatments, patients may be eligible for a course of open label treatments.~   "
21264|NCT03288701|"~     In this trial the measurement of whole body water will be compared to the standard method of~     measuring the body weight as treatment guidance in patients with decompensated heart failure.~     The Seca mBCA 515 [medical Body Composition Analyser] will be used to quantify the whole body~     water by using bioelectrical impedance analysis.~   "
21265|NCT03288688|"~     This study is a randomized clinical trial evaluating the effect of an exercise program~     designed specifically for orchestral musicians on performance-related musculoskeletal~     problems (PRMPs). Professional and conservatory-level orchestral musicians will be recruited.~     Half of the subjects will participate in an 11-week home exercise program and attend three~     group exercise sessions and an educational presentation on injury prevention, while the other~     half of the subjects will receive no intervention, and continue their usual activities.~   "
21266|NCT03288675|"~     Antidepressant-free unipolar melancholic depressed patients (at least stage 2~     treatment-resistant) will be selected by a certified psychiatrist, who will administer~     (semi-)structured clinical interviews. Because concomitant antidepressant treatment can~     confound outcome results, all patients will go through a medication washout before entering~     the study and they will be free from any antidepressant, neuroleptic and mood stabilizer for~     at least two weeks before entering the treatment protocol. Only habitual benzodiazepine~     agents will be allowed.~      STEP 1: Patients will be treated with in total 20 accelerated intermittent Theta Burst~     Stimulation (aiTBS) sessions (3000 pulses/session) over the left dorsolateral prefrontal~     cortex, which will be spread over 4 days. On each stimulation day, a given patient will~     receive 5 sessions with a between-session delay of 15 minutes. Patients will be randomized to~     receive either the real aiTBS or sham treatment (first week). However, the sham group will~     receive real aiTBS treatment with 10 days' time interval. The investigators expect that real~     aiTBS treatment and not sham will result in a significant and clinical meaningful response.~      STEP 2: To optimize treatment and reduce relapse following the iTBS treatment, in a stepped~     care approach, all patients then continue with cognitive control training (CCT) ten days~     later. This CCT consists of 20 sessions, spread over 4 weeks. Patients will be randomized to~     receive either real CCT or a control training. During this follow-up treatment, all patients~     will be prescribed antidepressant medication (SSRI) again. As iTBS treatment effects are~     known to decline over time, the investigators expect that combining aiTBS with a follow-up~     CCT therapy will stabilize the clinical effects over time compared to receiving the iTBS~     treatment alone.~      For baseline comparisons, patients will be closely matched for gender and age with~     never-depressed, medication-free healthy volunteers. No volunteer will undergo treatment.~   "
21267|NCT03288662|"~     the World Health Organization (WHO) has proposed a classification of histopathological thymic~     tumor and it significance in prognosis. Chest computed tomography (CT) is the most common~     method to evaluate thymic epithelial tumors before operation. Therefore, the question is to~     predict the histopathological type of thymic epithelial tumors before surgery based on~     CT-scan images , to help determine treatment strategy and prognosis. In Vietnam, there are no~     published literature on this issue.~   "
21268|NCT03288649|"~     Context: Psychiatric disorders (anorexia nervosa, depression, anxiety based school refusal)~     are a major public health concern in adolescence. Their treatment is a challenge for the~     families, the health care system and society. The treatment is complex and non-standardized.~     In clinical practice, the relational dimension between the stakeholders is recognized by all.~     Nevertheless no study has ever crossed their perspectives about therapeutic alliance in~     adolescent psychiatry.~      Objective: to explore, within a qualitative approach, how a therapeutic alliance is~     established in three different clinical situations according to the adolescents, their~     parents and their physicians by crossing their perspectives.~      Methods: This is a national (France) multi-center qualitative study based on 180~     semi-structured interviews. Participants (purposively selected until data saturation) came~     from three different sub-samples: (i) adolescents with anorexia nervosa (N =20) plus their~     parents (N=20) and their physicians (N=20), (ii) adolescents with depressions (N=20) plus~     their parents (N=20) and their physicians (N=20), and (iii) adolescents with anxiety-based~     school refusal (N=20) plus their parents (N=20) and their physicians (N=20). Data are~     collected through open ended semi structured interviews and independently analyzed with NVivo~     V.11 software by three researchers according to the principles of Interpretative~     Phenomenological Analysis.~   "
21269|NCT03288636|"~     The purpose of this study is to investigate the Pharmacokinetics and Safety of single dose of~     Ravidasvir and Danoprevir/r and repeated doses of Ravidasvir in combination with Danoprevir/r~     in healthy volunteers.~   "
21270|NCT03288623|"~     Dark chocolate (DC) is rich in epicatechin which augments nitric oxide (NO) production~     through endothelium-dependent influences. The increased bioavailability and activity of NO~     have been demonstrated to statistically increase flow-mediated dilation in healthy subjects~     and in hypertensive patients. DC supplementation has been hailed for its positive effects on~     cardiovascular health and it has been proposed as a booster of physical performance in~     athletes, however the mechanisms by which DC improves oxidative stress, vascular function and~     athletic performance are not fully understood. The investigators designed a human study~     assessing how DC improves NO bioavailability and activity in elite athletes. Twenty-four~     elite soccer players (aged 18-35 years old, all males) are divided in 2 groups and randomly~     assigned to receive DC (85% cocoa), 40g per day or white/milk chocolate (<35% cocoa) for 30~     days. The primary outcome measure is the evaluation of Soluble NOX2-derived peptide~     (sNOX2-dp), a direct marker of NADPH oxidase activation. The secondary outcome measures are~     other markers of oxidative stress, as the soluble P-selectin (sPs), Vitamin E, soluble CD40~     Ligand (sCD40L), a marker of in vivo platelet activation and flow-mediated dilation assessed~     by vascular ultrasound. All parameters are assessed at baseline and after 30 days in both~     groups.~   "
21271|NCT03288610|"~     The purpose of this study is to find a preoperative biomarker before cardiac surgery with~     cardiopulmonary bypass related to severe postoperative inflammatory response and circulatory~     complications. The investigators hypothesize that an increase of the preoperative stimulation~     of vasopressinergic system (in response to acute or chronic conditions) could lead to a~     microcirculatory dysfunction and favor the occurrence of vasodilatation during and after CPB~     and increase the symptoms of an inflammatory response after CPB. By defining a high risk~     population, a targeted strategy of monitoring and early or preventive treatment could improve~     postoperative prognosis.~   "
21274|NCT03288571|"~     Wharton Jelly derived Mesenchymal stem cells will be injected in the renal parenchyma of~     patients with Diabetic Nephropathy~   "
21275|NCT03288558|"~     Heart surgery is a life-saving intervention for hundreds of thousands of patients each year~     worldwide. Advances in technology and medical expertise have improved outcomes for these~     patients over the years. However, despite such advances, approximately 30% of patients~     develop lung complications (also called pulmonary complications) after heart surgery, which~     result in prolonged hospital stay, increased mortality and healthcare costs.~      During and immediately after heart surgery, the patient's breathing needs to be artificially~     controlled by a breathing machine, called mechanical ventilator. The medical literature has~     reported that in critically ill patients the use of specific settings on the breathing~     machine (so called protective mechanical ventilation) prevents lung complications and~     significantly decreases mortality. Studies show that such settings could also be beneficial~     for patients that undergo several types of planned surgery, however data regarding heart~     surgery patients (the most vulnerable to lung complications) are lacking.The aim of our study~     is to test whether the use of protective mechanical ventilation settings during and after~     heart surgery reduces lung complications compared to the current standard of care. The main~     innovation of this study is the application of a novel protective mechanical ventilation~     strategy to patients undergoing cardiac surgery, in order to reduce post-operative pulmonary~     complications.~   "
21276|NCT03288545|"~     This is a study that will test how an experimental drug (enfortumab vedotin) combined with a~     kind of anticancer drug called an immune checkpoint inhibitor (CPI) affects patients with~     cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the~     bladder, renal pelvis, ureter or urethra that has spread to nearby tissues or to other areas~     of the body.~      Patients will get the drugs twice every 21-day cycle. Patients will get enfortumab vedotin~     plus the CPI on day 1. Patients will get enfortumab vedotin only on day 8.~      This study will look at the side effects of giving the two drugs with each other. A side~     effect is a response to a drug that is not part of the treatment effect. This study will also~     test if the cancer shrinks with treatment.~   "
21277|NCT03288532|"~     RATIONALE: The current global standard of care after nephrectomy for localised RCC therefore~     remains active monitoring (i.e., observation by clinical and radiological means). 30-40%~     patients with initially localised RCC develop metastatic disease following nephrectomy. Need~     for adjuvant therapy is most marked in the high risk population where outcomes are~     predictably poor. However, the risk of recurrence in patients who are of intermediate risk of~     recurrence is not insignificant. Unfortunately, despite showing efficacy in advanced RCC, the~     results in the adjuvant setting, so far, are inconclusive.~      AIM: RAMPART is a phase III Multi-Arm Multi-Stage randomised controlled platform trial,~     initiated with three arms. The trial is assessing if durvalumab monotherapy or the~     combination of durvalumab and tremelimumab can improve Disease Free Survival (DFS) or Overall~     Survival (OS) compared to the current global standard-of-care (active monitoring). At the~     start of recruitment, patients with Leibovich scores 3 to 11 will be eligible for~     randomisation. Accrual of intermediate risk patients (Leibovich scores 3 5) will stop after 3~     years or when intermediate risk patients contribute 25% of the total accrual target,~     whichever is earlier. Recruitment of patients with Leibovich scores 6 to 11 will continue~     until the accrual target is reached.~   "
21278|NCT03288519|"~     Background: Earlier treatment and resolution for patients with cerebral aneurysms is now~     possible due to earlier diagnosis. This observational study aims to evaluate the~     intraoperative cardiovascular parameters in patients with cerebral aneurysms undergoing~     endovascular therapy.~      Method: This is an observational, prospective, before-after study. Patients ≥ 18 years old~     diagnosed with an unruptured cerebral aneurysm or subarachnoid hemorrhage (SAH) (Hunt & Hess~     grade I or II) undergoing endovascular treatment under general anesthesia between April 2015~     and February 2017 were included. Non-invasive measurements of hemodynamic variables were~     collected at six time points during the procedure (T1 to T6). Statistical analysis was~     performed by using central tendency measures for quantitative variables and absolute /~     relative frequency measurements for qualitative variables.~   "
21279|NCT03288506|"~     Depression impacts 1 in 5 people in the United Kingdom and is a significant risk factor for~     self-harming behaviours and suicide. Research has shown that those experiencing depression~     may feel embarrassed about seeking help from a health professional and ultimately decide not~     to seek support at all. This project seeks to give those people an alternative option to~     face-to-face support by developing a new online service using video conferencing technology.~     In previous studies, this technology has shown to be beneficial in treating a number of~     mental health problems. It may also be less expensive to run. However, as no widely available~     services of this type exist in the UK the full extent of potential benefits is unknown. The~     project seeks to answer the following questions:~        -  What is the likely interest in video conferencing services for depression?~        -  Which groups of people are likely to use the service?~        -  How much will this service cost?~        -  How much change is likely to occur when receiving therapy via video conferencing?~      In order to answer these questions, Queens University Belfast are collaborating with AWARE~     NI, the national depression charity for Northern Ireland. Recruitment of participants who are~     interested in the service and delivery of the video conferencing support groups will be~     through AWARE NI. Results will be compared from groups that receive the video-conferencing~     service and those who are on a waiting list. Participants in both groups will be asked to~     complete surveys and take part in interviews before and after the therapy takes place. The~     study will have two main phases:~      Phase 1: The development and in-house testing of an intervention protocol tailored towards~     Video Conferencing (VC) based delivery of current face-to-face peer support services. This~     will include interviews with facilitators, staff and current AWARE NI service users and~     observations of face to face groups.~      Phase 2: Delivery of an 8-week group based VC support service for adults with depression. A~     between groups design comparing the intervention group and a waiting list control group will~     be used. Outcome measures will be recorded at baseline, week eight and six months using~     validated measures. Qualitative data in the form of interviews and fieldwork observations~     will also be gathered during this 8-week period.~      Results will be used to inform development of a larger trial to test the effectiveness of~     group based video conferencing for adults with depression.~   "
21280|NCT03288493|"~     This is a Phase 1, open-label, multi-center study of P-BCMA-101 autologous T stem cell memory~     (Tscm) CAR-T cells in patients with relapsed and/or refractory MM.~   "
21281|NCT03288480|"~     Study PT-112-102, a multicenter, open-label dose-finding and pharmacokinetic study of PT-112~     in patients with relapsed or refractory multiple myeloma.~      This is designed as a two-part study. In the first part of the study, cohorts of three~     patients (expanded to six patients in the event of a dose-limiting toxicity) will receive~     escalating doses of PT-112 until the MTD is reached, based on tolerability observed during~     the first 28 days of treatment. In the second part of the study, an expansion cohort of 14~     patients will be treated at the recommended dose to confirm the tolerability of treatment and~     evaluate evidence of treatment efficacy.~   "
21966|NCT03279497|"~     The study evaluates the effectiveness of the game-intervention in promotion of physical~     activity self-efficacy and physical activity behavior among early adolescents (10-13 year~     olds). Half of the study participants will receive the game-intervention and half of the~     study participants will receive a commercially available sport and fitness application for~     running, cycling and every-day training.~   "
21282|NCT03288467|"~     .There is no general agreement regarding the optimal concentration of sodium hypochlorite to~     be used in endodontic treatment.Therefore, this study aims to evaluate the effect of sodium~     hypochlorite concentration on the success of primary root canal treatment. The study~     population comprised of patients requiring primary root canal treatment following the~     diagnosis of pulpal necrosis with chronic apical periodontitis in mature mandibular first and~     second molars.Patients were randomly allocated in either High concentration or Low~     concentration group.~   "
21283|NCT03288454|"~     This study is a randomized, single-blind, placebo-controlled study to assess the efficacy and~     safety of ciraparantag administered to healthy volunteers anticoagulated with apixaban~     measuring clotting times using Whole Blood Clotting Time (WBCT).~   "
21284|NCT03288441|"~     Background: Antithrombotic therapy in the context of treatment related thrombocytopenia (i.e.~     low levels of platelets) is not uncommon. Guidelines are based upon a paucity of~     retrospective data and focus on the scenario of cancer associated venous thrombosis and low~     molecular weight heparin treatment. Even less is known regarding direct oral anticoagulants,~     antiplatelet therapy, or anticoagulation prescribed for other indications.~      Aims: The study aims are to evaluate how physicians manage anticoagulant and antiplatelet~     medication in patients with hematological malignancy and thrombocytopenia, and to assess the~     frequency of bleeding and thrombosis. Additional aims are to assess how management changes~     affect drug activity and blood clotting (coagulation), and to evaluate the use of platelet~     transfusions.~      Design: The investigators plan a multinational prospective registry of patients admitted to~     the inpatient hematology department or outpatient clinic at one of the study centers.~     Patients with hematological malignancies, platelets below 50 X 109/L, and anticoagulant~     and/or antiplatelet medication will be studied.~      Patients will be enrolled when the combination of antiplatelet/anticoagulant medication and~     thrombocytopenia is first detected. Patients will be followed until 30 days after the~     baseline study visit (which occurs 30 days after enrollment or when platelets < 50*109/L,~     whichever come first) or death. Patients will be indexed at the time of baseline visit.~      Patients will be excluded from study analysis if one of the following events occurs before~     study index: Withdrawal of consent, death, clinically-relevant non-major bleeding or the~     composite primary outcome.~      Risk factors for bleeding and thrombosis will be recorded at baseline. Parameters from~     routine blood tests will be recorded throughout the study. During the study major bleeding~     events and thrombosis will be recorded. Investigational blood tests assessing coagulation and~     drug activity will be drawn at baseline (=study index). Throughout the study all management~     decisions regarding antithrombotic therapy, including platelet and red blood cell~     transfusion, will be recorded. This is an observational study and management will be solely~     at the discretion of the physician.~      Analysis: The investigators will first look at the frequency of either bleeding or thrombosis~     according to the type of management strategy and evaluate the platelet threshold at which a~     given management strategy is employed.~      At the next stage, in selected subgroups, the optimal management strategy with respect to~     bleeding/thrombotic risk, will be determined.~   "
21285|NCT03288428|"~     to compare the analgesia and side effect of nalbuphine and morphine for elective Laparoscopic~     myomectomy.~   "
21286|NCT03288415|"~     The study aims at developing and validating an integrated clinico-molecular model for an~     accurate survival prognostication in newly diagnosed SMZL.~   "
21287|NCT03288402|"~     Measurement of plasma chromogranin A remains the most commonly used biomarkers for both~     screening and monitoring of patients with gastro-entero-pancreatic neuroendocrine tumours~     (GEP-NET), despite several limitations that include: lack of a reference CgA standard; wide~     variations depending on the used assay in different laboratories; and varying sensitivity~     ranges from 60 to 90% with low specificity <50%, depending on the population studied.~      Surprisingly, and to the best of our knowledge, only three studies with small numbers of~     participants have been published that have investigated possible effects of food intake on~     the measurement of CgA. Most have been performed in healthy controls or patients on treatment~     with proton pump inhibitors for chronic gastritis (up to n = 11 per group) but only one study~     has investigated patients with GEP-NET, where n = 6 patients with gastric NET were included.~      In this study, the investigators aim to assess the time dependent effects of normally~     ingested diet (5-item English breakfast; or tea or coffee; or ongoing fasted state) on plasma~     chromogranin A measurements, using timed measurements over 180 min following an > 10 hours~     overnight fast, in a randomised double-crossover design. The investigators aimed to include~     25 - 35 patients with a histologically confirmed diagnosis of a GEP-NET of varying primary~     tumour location, tumour stage, grade; and presence or absence of treatment with long acting~     somatostatin analogues; as well as 10 - 15 healthy controls. In an additional small subgroup~     of patients who are initiated on treatment with GLP-1 analogues i.e. for type 2 diabetes or~     obesity, the investigators aim to establish whether injection of GLP-1 analogues has any~     effects on plasma CgA measurements.~   "
21288|NCT03288389|"~     The purpose of this study is to determine the clinical effectiveness of an all-natural,~     patented wafer with active ingredients that are FDA approved as Generally Recognized as Safe~     (GRAS) Reference: US Federal Drug Administration (1970) Scientific Literature Reviews GRAS~     Report, PB-241 970. Active Ingredients: Lecithins. .In this study the investigators will~     evaluate the efficacy of this dietary product called NTFactor Lipids® made by Nutritional~     Therapeutics, Inc. of New York on pain, fatigue and gastrointestinal symptoms as well as~     quality of life indicators in adult male and female participants with fibromyalgia. The~     addition of NTFactor Lipids to the diet is expected to improve cellular energy function,~     decrease fatigue and pain and lower the severity of other symptoms and improve quality of~     life indicators in Fibromyalgia. This study will be a randomized, placebo-controlled,~     cross-over study.~   "
21289|NCT03288376|"~     This is a prospective multipart clinical performance study to compare the ability of the~     SnoreSounds algorithm with polysomnography (PSG) and a type III Home Sleep Testing (HST)~     device to identify patients with obstructive sleep apnea (OSA).~   "
21290|NCT03288363|"~     TDCS is a rapidly expanding technique, used to treat cognitive difficulties associated with~     many pathologies (Parkinson's disease, rehabilitation after head trauma, etc.), but which~     remains of the field of research.~      Its use remains very experimental, and concerns the exploration of cognitions, in healthy and~     diseased subjects. There are not many studies on the elderly subject with Alzheimer's~     disease, nor do they document the medium- and long-term effect (more than one month), nor the~     effect on geriatric parameters such as Fragility indices and the risk of falls, especially at~     home. These characteristics are decisive because they define the level of autonomy.~      The investigators therefore wish to study the effect of a 2-week treatment with tDCS (tDCS~     active) versus placebo (2-week tDCS group) for a three-month period.~   "
21414|NCT03286751|"~     This study compares LY900014, a drug that lowers blood sugar, with insulin lispro (Humalog).~     Both drugs are given by injection under the skin of the abdomen. The study will be conducted~     in healthy people to investigate how quickly and how much LY900014 is absorbed and the effect~     of different doses of LY900014 on blood sugar levels in comparison with insulin lispro. The~     study will last about 7 to 12 weeks for each participant, including screening and follow up.~     Screening is required within 28 days prior to entering the study.~   "
21415|NCT03286738|"~     -  Registry~        -  Multicenter, prospective observational study~        -  Observe adverse events and efficacy in recruited patients for 3 years under real world~          settings.~   "
21291|NCT03288350|"~     This is a single-center, single-arm, open-label, Simon 2-stage, phase II trial in up to 55~     patients with a potentially resectable, histologically-proven, adenocarcinoma or poorly~     differentiated carcinoma of the stomach, esophagogastric junction (EGJ), or lower third of~     the esophagus.~      Patients will receive neoadjuvant therapy consisting of 4 cycles of avelumab added to the~     modified chemotherapy regimen of docetaxel, cisplatin, 5- fluorouracil. Following surgery,~     pathologic response will be assessed. Patients will then receive adjuvant therapy consisting~     of 4 cycles of mDCF + avelumab. Patients will be followed to assess two-year disease-free~     survival rates.~      The primary objective of this study is to assess the effect on pathologic complete response~     rate (pCR) of adding avelumab to an mDCF regimen. The secondary objectives of this study are~     to determine the safety of adding avelumab to an mDCF regimen and assess its effect on~     two-year disease-free survival.~   "
21292|NCT03288337|"~     The goal of this study is to get a better understanding of the impact of the skin condition,~     Hidradenitis Suppurativa, on quality of life function of patients with this condition.~     Patients with HS will be asked questions about demographics including gender, age, and~     ethnicity. They will also be asked to complete questionnaires to determine how their skin~     condition affects their life. Study participation will last for 1 day, with potential for~     follow-up in the future.We hope this information will help us improve our treatment for this~     skin condition.~   "
21293|NCT03288324|"~     This 76-week, 3-part Phase 1b/2 study is intended to evaluate the pharmacological properties~     (pharmacokinetics and pharmacodynamics), safety, tolerability and preliminary effectiveness~     of TOFA administrated to young adults (18-30 years) with moderately to severely active~     SLE-CL. Subjects will be studied at the Cincinnati Children's Hospital Medical Center (CCHMC)~     and recruited locally.~      Cohort 1 (n=10, weight > 40kg and age > 18 years and ≤ 30 years ) will undergo intense~     PK-sampling to determine exposures following TOFA dosed at 5 mg BID. TOFA dose escalation~     will not be considered for inadequate response of SLE-CL.~      Cohort 2 (n=10, weight > 40kg and age > 18 years and ≤ 30 years) will be treated with the~     same dose as Cohort 1. No PK sampling will occur for Cohort 2. Enrollment of Cohort 2 will~     only start once Cohort 1 has completed 8 weeks of TOFA and results of PK analyses from Cohort~     1 are available.~        -  Part A (up to week 8) requires stable background medications;~        -  Part B (up to week 24) allows for tapering of corticosteroids (CS) in the setting of~          significant clinical improvement of SLE-CL as defined by a decrease in Cutaneous Lupus~          Erythematosus Disease Area and Severity Index (CLASI) activity score by >50% from~          baseline , and~        -  Part C (until week 76) permits tapering of other background medications in subjects with~          clinical remission of SLE- CL (CLASI activity score=0). TOFA dosing is kept stable~          during Part C.~   "
21294|NCT03288311|"~     Invasive mechanical ventilation is common in the medical intensive care unit, and the period~     of time following extubation remains high risk as 11 to 15% of patients require reintubation~     after their first extubation. Reintubation is associated with increased rates of nosocomial~     infection and is an independent predictor of mortality. Non-invasive ventilation and high~     flow nasal cannula are the only therapies that have been shown to reduce the rate of~     reintubation. Recent clinical trials suggest that all patients might benefit from some form~     of post-extubation respiratory support, but use of these therapies in usual care remains low.~     PROPER is a cluster-randomized, multiple-crossover trial comparing a respiratory therapist~     driven protocol to provide post-extubation respiratory support to all patients, compared to~     usual care. The trial will enroll patients undergoing extubation in the Medical ICU at~     Vanderbilt from October 2017 until March 2019. The primary outcome will be reintubation~     within 96 hours.~   "
21295|NCT03288298|"~     In vitro study to examine whether luteolin and nano-luteolin exert an inhibitory effect on~     tongue squamous cell carcinoma cell line by inducing apoptosis, and to assess if~     nano-luteolin has more efficient apoptotic activity than luteolin on tongue squamous cell~     carcinoma cell line.~   "
21296|NCT03288285|"~     Hemodiafiltration (HDF) is a choice of treatment modalities for patients with end-stage renal~     disease. Hemodiafiltration, combining diffusion and convection, may increase removal of large~     and middle molecule uremic toxins comparing to conventional hemodialysis. The techniques of~     hemodiafiltration include pre-dilution and post-dilution according to the infusion site of~     substitution fluid. Post-dilution HDF is most widely used because of higher removal rate of~     uremic toxins. However, hemoconcentration and clotting of membrane limit its further~     clearance of toxins. Pre-dilution may preserve membrane permeability and maintain hemodynamic~     status. Although lower clearance of small molecule uremic toxins, one study in Japan showed~     survival benefits of pre-dilution HDF, comparing to post-dilution HDF. The aim of this study~     was to compare pre-dilution and post-dilution HDF in terms of their clinical and biological~     parameters and clearance of uremic toxins by using cross-over study design.~   "
21297|NCT03288272|"~     Whole Brain Radiotherapy (WBRT) has been established as the treatment standard in patients~     with multiple cerebral metastases from solid tumors. However, intracerebral recurrence is~     possible and a repeated WBRT may be indicated to improve intracerebral tumor control. Each~     institutsion offers different dosing regimens, which have all been published to be safe and~     effective. Some favor best supportive care only.~      The current study protocol is aimed at evaluating primarily the toxicity as well as~     secondarily the local and loco-regional tumor control, overall survival and QoL after~     repeated WBRT using 2 different dose concepts (20 Gy in 10 Fx vs. 30 Gy in 15 Fx) compared to~     BSC.~   "
21312|NCT03288077|"~     Identifying non-pharmacological means of enhancing sleep is an important area of research for~     elite athletes. Research completed at the AIS has identified that some athletes have~     difficulties falling and staying asleep during both training and competition.~      There are a number of dietary components such as nutrients and certain dietary supplements~     that are purported to decrease sleep latency and increase quality of sleep. While many of~     these interventions have been investigated in isolation, no research has examined different~     combinations and/or amounts of these substances to determine the resultant effects on sleep.~     The results of such a systematic investigation could produce an effective diet based sleep~     product (Sleep Drink').~      The optimal components, amounts, and timing of intake of such a Sleep Drink will be explored.~     Additionally, the effects on sleep will be evaluated using the gold standard of sleep~     measurement: polysomnography.~   "
21298|NCT03288259|"~     Transnasal Endoscopy in Obese Patients are Candidates for Bariatric Surgery~      Introduction and Objectives: high digestive endoscopy (HDE) is an important tool in the~     preoperative period of bariatric surgery. Patients with excess weight have a higher risk of~     cardiorespiratory complications during this procedure, being that the transnasal endoscopy~     (TNE) with an endoscope-thin is a safe alternative, comfortable and great value for money.~     The TNE allows the study of the upper gastrointestinal tract without the need for sedation.~     The objective of this work was to evaluate the feasibility, tolerance and safety of TNE in~     obese patients are candidates for bariatric surgery. Methods: This was a prospective study~     with all patients with indication for surgery of obesity undergoing endoscopic transnasal~     preoperatively, between December 2016 and August 2018, at the Hospital of the Federal~     University of Minas Gerais. The variables evaluated were: age, gender, suitability of the~     exam, tolerance by the patient through the visual analogue scale, incidence of complications~     and need for sedation. Oxygen saturation, heart rate and systolic blood pressure were~     recorded. Conclusion: The transnasal endoscopy is a feasible alternative, well tolerated and~     safe the conventional endoscopy in evolution the preoperative bariatric surgery. The benefits~     of transnasal endoscopy in obese patients mainly consist in carrying out the procedure~     without sedation, which may provide reduction of risks, costs and waive the need for a~     companion. Key words: transnasal endoscopy - Obesity - endoscopy without sedation.~   "
21299|NCT03288246|"~     This study is designed as an individual randomized trial among 150 HIV-infected adolescents~     aged 10-24 years who have been on ART for >6 months and will be randomized in a 1:1 fashion~     to one of two arms: 1) the intervention arm (POC) will receive a POC VL test with adherence~     counseling informed by the VL result the same day as testing vs. 2) the standard-of-care arm~     (SOC) will receive a standard laboratory-based test with adherence counseling informed by the~     VL result 1 month later. The study tests an intervention, POC VL testing, which reduces the~     time between sample collection and participant receipt of results, thus decreasing the number~     of steps in the HIV treatment cascade. This intervention was developed to addresses health~     systems-based barriers which delay clinic, laboratory, and data management processes for VL~     monitoring for HIV-infected adolescents. Our results will contribute to research on whether~     POC VL testing is a feasible testing method which could be incorporated into health systems~     in similar resource-limited settings and whether it can improve outcomes among HIV-infected~     adolescents.~   "
21300|NCT03288233|"~     Hemoglobin A1C (HbA1c) is the cornerstone of blood sugar monitoring. As HbA1c is formed by~     the covalent reaction of glucose with hemoglobin throughout the lifespan of the red blood~     cell (RBC), it is used as a surrogate marker for integrated mean blood glucose over time. The~     HbA1c value therefore is dependent on the average amount of time the RBC spends in the~     circulation (mean RBC age or MRBC). However, our previous studies measuring red cell lifespan~     using either an age cohort label (ex vivo labeling with biotin) or a population label (stable~     isotope) have demonstrated, contrary to established dogma, that the MRBC varies substantially~     among individuals and is sufficiently variable to affect HA1c interpretation in a significant~     percentage of individuals with diabetes. Although the stable isotope method is suitable for~     clinical studies, it has limited potential for application to large population of subjects. A~     potential alternative to the stable isotope approach that could be applied routinely to the~     average patient in the clinic is measurement of exhaled carbon monoxide (eCO) concentration,~     a reflection of RBC heme turnover. In general, the primary advantage of applying exhaled~     breath analyses to human clinical diagnostics and therapeutic monitoring is that this~     technique is noninvasive, safe, simple, and provides near-real time measurements. The purpose~     of this observational study is to optimize the collection of eCO in a normal control~     population followed by measurement in a cohort of subjects previously assessed by either the~     SI or biotin methods for comparison.~   "
21301|NCT03288220|"~     Background:~      When people have a stroke, they often have difficulty moving their arms and hands.~     Transcranial magnetic stimulation (TMS) can improve how well people with and without stroke~     can move their arms and hands. But the effects of TMS are minor, and it doesn t work for~     everyone. Researchers want to study how to time brain stimulation so that the effects are~     more consistent.~      Objective:~      To understand how the brain responds to transcranial magnetic stimulation so that treatments~     for people with stroke can be improved.~      Eligibility:~      Adults ages 18 and older who had a stroke at least 6 months ago~      Healthy volunteers ages 18 and older~      Design:~      Participants will have up to 5 visits.~      At visit 1, participants will be screened with medical history and physical exam.~     Participants with stroke will also have TMS and surface electromyography (sEMG).~      For TMS, a brief electrical current will pass through a wire coil on the scalp. Participants~     may hear a click and feel a pull. Muscles may twitch. Participants may be asked to do simple~     movements during TMS.~      For sEMG, small electrodes will be attached to the skin and muscle activity will be recorded.~      At visit 2, participants will have magnetic resonance imaging (MRI). They will lie on a table~     that slides into a metal cylinder in a strong magnetic field. They will get earplugs for the~     loud noise.~      At visit 3, participants will have TMS, sEMG, and electroencephalography (EEG). For EEG,~     small electrodes on the scalp will record brainwaves. Participants will sit still, watch a~     movie, or do TMS.~      Participants may be asked to have 2 extra visits to redo procedures.~   "
21313|NCT03288064|"~     The purpose of the present study is to investigate the effect of pre-exercise supplementation~     of Corinthian currant on metabolism, performance and blood redox status during, and after an~     acute bout of prolonged exercise.~      Methods: Eleven healthy male adults (18 - 45y) performed an acute bout of prolonged cycling~     in a crossover fashion. Each bout consisted of a 90 min constant-intensity (70 - 75% VO2max)~     submaximal glycogen depletion trial, followed by a time trial (TT) to exhaustion (95%~     VO2max), with a wash out period of 2 weeks between bouts. During each experimental condition~     and 30 min prior to exercise, participants consumed an isocaloric (1.5 g CHO/kg body mass)~     amount of randomly assigned Corinthian currants, glucose drink, or water. Blood was drawn at~     baseline, 30 min after the supplement consumption (pre-exercise) and at 30, 60, 90 min of~     submaximal trial, after TT, and 1 h after the end of exercise (post TT), for the assessment~     of metabolic changes and redox status alterations.~   "
21967|NCT03279484|"~     The primary objective of this study is to assess the safety and electrical performance of~     Left ventricular (LV) NAVIGO 4LV leads, pre-shaped (S-shaped&U-shaped: NAVIGO 4LV 2D, NAVIGO~     4LV ARC) and Straight (NAVIGO 4LV PILOT), with IS4 connector~   "
21302|NCT03288207|"~     Background:~      Heart disease is a leading cause of death. People can reduce their heart disease risk by~     exercising more. Mobile health technology may make people more successful at increasing their~     exercise. This includes things like physical activity monitors and smartphone apps.~      Objective:~      To find out if mobile health technology can increase physical activity.~      Eligibility:~      African American women ages 18-75 who:~        -  Are overweight or obese~        -  Live in certain areas near Washington, DC~        -  Are pre-diabetic~        -  Have a smartphone that can use the study app~      Design:~      At visit 1, participants will~        -  Answer survey questions. These may be about medical history, physical activity, and~          weight. They may also cover body image, health perception, and spirituality.~        -  Have body size measured and get blood tests~        -  Get a device to wear on the wrist. It will record physical activity and hours of sleep.~        -  Learn how to download and use the study mobile app~      For 2 weeks, researchers will collect data about participants physical activity.~      Then participants will have a study visit with additional blood tests.~      All participants will get messages from the app that encourage exercise.~      Some participants will get data from the app about exercise near their home or work.~      Some participants may get face-to-face coaching.~      Participants may get wireless devices. These measure body weight, blood pressure, and blood~     glucose. Participants can measure these at home and upload the data to the app for the study.~      Participants will have visits after 3 and 6 months. They will repeat the visit 1 tests.~   "
21303|NCT03288194|"~     This research study has been designed to test the efficacy of telephone-delivered~     Problem-Solving Treatment (PST) for improving the quality of life (QoL) in outpatients with~     stable heart failure (HF).~   "
21304|NCT03288181|"~     Patients with peripheral arterial disease often have walking impairment due to insufficient~     oxygen supply to lower extremity skeletal muscle. In an aging rat model, we have previously~     shown that daily calf muscle stretching improves endothelium-dependent dilation of soleus~     muscle arterioles and blood flow during exercise. The effect of muscle stretching on~     endothelial function and walking distance in patients with peripheral arterial disease is~     unknown. We performed a prospective, randomized, non-blinded, crossover study in 13 patients~     with stable symptomatic peripheral artery disease. Patients were randomized to undergo either~     4 weeks of passive calf muscle stretching (ankle dorsiflexion splints applied 30 minutes/day,~     5 days/week) followed by 4 weeks of no muscle stretching (control group) and vice versa.~     Endothelium-dependent flow-mediated dilation and endothelium- independent~     nitroglycerin-induced dilation of the popliteal artery and a 6 minute walk test were~     evaluated at baseline and after each 4 week treatment interval. Patients crossed over to the~     other treatment arm after 4 weeks and endothelium-dependent flow-mediated dilation and~     endothelium- independent nitroglycerin-induced dilation of the popliteal artery and the 6~     minute walk test were repeated.~   "
21305|NCT03288168|"~     Recently, diagnosis and treatments for medulloblastoma becomes more complicated than before~     since the new World Health Organization (WHO) diagnosis criteria has put molecular marker~     onto an ever important position. Reports and studies revealed highly correlated connection~     between subgroups of medulloblastoma and patient outcomes. Children's Oncology Group (COG)~     has launched many new studies on molecular subgroups-based specific treatment trails. In~     China, children and adolescents with brain tumor have been treated variously for a long time~     in lack of standardized comprehensive treatments. Same poor situation in basic research and~     clinical studies makes the Chinese children with brain tumor hardly catch up with~     international level in molecular diagnosis and specific treatments. There are limited~     studies, which were conducted by immunohistochemistry for identifying medulloblastoma~     molecular subgroups, indicating the similar correlation of the subgroups and outcomes to~     world-wide reports. As the Children's Neuro-Oncology Group (CNOG) was established in China in~     May 2017, it makes studies from multiple centers in children's brain tumors become practical.~     And the availability of DNA methylation array, NanoString and other methods in~     medulloblastoma subgroup identification assures the quality of the method for this study.~   "
21306|NCT03288155|"~     This study determines to evaluate the effectiveness of the daily consumption of~     flavonoid-rich cocoa in the treatment of fatigue in Parkinson's patients. The participants~     were divided equally between the flavonoid-rich cocoa (device) and control cocoa groups. The~     participant will engage in a six day trial, with measures taken at Day 1 and Day 6.~   "
21307|NCT03288142|"~     Investigators at Northwestern University will partner with Omron Healthcare Co., Ltd.~     (hereinafter referred to as Omron) to conduct a randomized controlled trial of a~     hypertension personal control program (HPCP), known as Lark HTN Pro with a home blood~     pressure monitoring device (HBMD) compared to a HBMD alone. The overarching goal of this~     study is to investigate the effects of the HPCP on blood pressure, blood pressure~     self-management behaviors, and healthy lifestyle behaviors among adults with hypertension.~   "
21308|NCT03288129|"~     This study will assess the retention rate of perampanel when given as monotherapy or first~     adjunctive therapy in participants with partial-onset seizures or primary generalized tonic~     clonic seizures. The study consists of 4 periods: a Screening Period (to start no earlier~     than 6 weeks before the first dose of study drug), a Titration Period (13 weeks), a~     Maintenance Period (39 weeks), and a Follow-Up Period (4 weeks).~   "
21309|NCT03288116|"~     patients with keratoconus in one eye and forme fruste keratoconus in the fellow eye compared~     to normal subjects .the patients were examined by schemipflug imaging system (Pentacam)~   "
21310|NCT03288103|"~     This is an open-label, single-arm prospective pilot study to study the effects of a single~     dose regimen of daily growth hormone medication (Norditropin) on pre-pubertal children with~     Aggrecan deficiency. The growth response will be tracked over a 12 month period.~   "
21311|NCT03288090|"~     Cerebral infarction is a type of stroke that can lead to sometimes disabling sequelae. Among~     these sequelae, fatigue is frequently reported by patients. It is therefore important for~     doctors to understand why patients suffer from fatigue after cerebral infarction and to~     determine whether treatments given for the cerebral infarction may have an impact on this~     fatigue.~      The aim of this research was to study the frequency of fatigue after cerebral infarction, the~     associated factors, in particular the impact of treatments administered in the acute phase.~   "
21346|NCT03287635|"~     Study Title: A Phase 4 Study to Assess the Clinical Efficacy of H.P. Acthar Gel 80 U/ml to~     Improve the Signs and Symptoms in Subjects with Dry Eye Disease~   "
21314|NCT03288051|"~     Maintaining satisfactory tissue perfusion is an essential of success during reconstructive~     free flap surgery following malign oral cavity tumours. Intra- and postoperative~     goal-directed fluid therapy is an appropriate tool for that. Continuous cardiac output~     monitoring based fluid loading (complemented with vasopressor and/or inotropes if necessary)~     might be superior to conventional, central venous and arterial pressure monitoring in terms~     of morbidity, complications, optimal fluid balance and days spent in hospital. However, there~     is no data describing the effects of goal-directed fluid therapy (crystalloid or colloid) on~     microcirculation of free flaps implanted in the oral cavity during the post-operative period.~     The aim of this study is to observe the effects of continuous macrohaemodynamic monitoring~     based, goal-directed fluid therapy on microcirculation of forearm flaps during the~     perioperative period.~   "
21315|NCT03288038|"~     A Multi-center, Randomized, Double-blind, Phase III Clinical Trial to Evaluate the Efficacy~     and Safety of Combination Therapy of Rosuvastatin and Ezetimibe and Rosuvastatin Monotherapy~     in Patients with Primary Hypercholesterolemia~   "
21316|NCT03288025|"~     The purpose of this study is to investigate the extent to which diet and exercise may improve~     PAH through the modulation of insulin sensitivity. The central hypothesis is that~     dysregulated glucose metabolism elicits a response in PAH patients that can be modified by~     exercise and diet, thereby leading to improvements in pulmonary vascular disease.~   "
21317|NCT03288012|"~     The focus of the study is the pathophysiological mechanism of allo-antibody formation after~     red blood cell transfusion in sickle cell disease patients.~   "
21318|NCT03287999|"~     Severe haemophilia A and B (SHA, SHB) are X - linked inherited bleeding disorders,~     characterised by factor VIII and IX levels of <1 IU/dL respectively. The mainstay of~     treatment in SHA and SHB is replacement therapy with intravenous infusions of factor VIII and~     IX. However, there is significant variability in the bleeding phenotype within severe~     haemophiliacs with some presenting with minimal bleeding episodes even on less intensive~     treatment regimens. A significant contributor to inter-individual variability in the bleeding~     phenotype is the coagulation phenotype, but there are no established assays in routine~     clinical practice that can be used to quantify this. This study aims to study novel assays~     and characterise the observed phenotypic heterogeneity.~   "
21319|NCT03287986|"~     The main objective of this study is to show MRI functional and structural differences between~     depressed elderly patients with a history of attempted suicide compared to depressed elderly~     patients with no history of attempted suicide and to elderly subjects with no personal~     history of depression or attempted suicide (healthy controls).~   "
21320|NCT03287973|"~     Obstructive sleep apnea (OSA) is a common form of sleep-disordered breathing (SDB). Weight~     reduction has always been advocated in patients with OSA who are overweight and may lead to~     improvement in the severity of OSA. Previous study reported a randomized controlled trial of~     dietician-led lifestyle modification program (LMP) in 104 patients and found that LMP group~     had significantly more weight loss and reduced OSA severity, and the response was sustained~     after 8 months.~      This study is aimed to compare the effect of weight loss or CPAP alone on subclinical~     inflammation, insulin resistance and blood pressure in patients with obesity and~     moderate-to-severe obstructive sleep apnea, stratified according to the degree of~     craniofacial restriction.~      The study plans to recruit consecutive patients who have been referred to the Respiratory~     Clinic at the Prince of Wales Hospital with clinical suspicion of sleep-disordered breathing~     with specific study entry criteria including an age of 18 or more, body mass index (BMI) >25~     kg/m2, and moderate to severe OSA diagnosed by home sleep study. Patients having conditions~     that will affect the serum level of hsCRP will be excluded.~   "
21321|NCT03287960|"~     This study is assessing the effect of setmelanotide (RM-493) on weight and other factors in~     patients with Leptin Receptor (LEPR) deficiency obesity due to rare bi-allelic~     loss-of-function LEPR genetic mutation.~   "
21322|NCT03287947|"~     The purpose of this trial is to evaluate the disease control rate of subjects with metastatic~     appendiceal cancer for whom initial fluoropyrimidine-based chemotherapy has failed. Based on~     previous studies, the anticancer activityof nintedanib in lung and ovarian cancer trials,~     along with the similarities between appendiceal and colorectal cancer and potentially ovarian~     cancer, warrant additional investigation for the optimal treatment of metastatic appendiceal~     carcinomas.~   "
21323|NCT03287934|"~     patient with non-restorable tooth in the esthetic zone will be recruited in the study. a~     traumatic is done and implant will be placed using either stereolithographic guides for~     control group or selective laser sintering group for intervention group.~   "
21324|NCT03287921|"~     Current guideline-based criteria defining COPD do not meet the challenges set by the complex~     pathophysiology of the disease. Hyperinflation and affection of the small airways are two~     components that are not represented in current diagnostic concepts and may relate to early~     stages of the disease. Moreover, optimal therapeutic interventions in patients with these~     distinct features remain unclear. The investigators therefore aimed to evaluate novel or not~     widely used diagnostic approaches for the detection and initiating therapeutic strategies in~     early stage COPD within the GOLD recommendations.~   "
21325|NCT03287908|"~     The purpose of this First-in-Human Phase 1 study is to determine during the escalation part~     if AMG 701 given as weekly short term IV infusions is safe and tolerable followed by a dose~     expansion part to gain further efficacy and safety experience with AMG 701 in adult subjects~     with relapsed / refractory multiple myeloma. The study will be conducted in multiple sites~     and test increasing doses of AMG 701. The safety of subjects will be monitored by intensive~     assessments of vital signs, electrocardiograms, physical examinations, and laboratory tests.~   "
21326|NCT03287895|"~     Objective~      The primary objective is to evaluate the efficacy of a multi-faceted, clinical decision~     support intervention aimed at improving the quality of decisions about Cardio Pulmonary~     Resuscitation (CPR) for seriously ill, elderly patients in hospital.~      The hypothesis is that fewer patients in the intervention group will have a documented order~     for CPR and they will have greater satisfaction with decision making about CPR than patients~     in the control group.~   "
22013|NCT03278886|"~     This study is a randomized controlled trial (RCT) to assess the feasibility, tolerability,~     and safety of using opioid receptor antagonists (naltrexone and nalmefene) to treat pain~     among HIV-infected persons with heavy alcohol use and chronic pain.~   "
21327|NCT03287882|"~     The primary aims of this study are: 1) To evaluate the impact of supplementation with~     multiple micronutrients (MMN) from preconception and life skills education among women~     15-18.9 years of age at enrolment on the prevalence of anemia in a population setting; and 2)~     To evaluate the impact of supplementation with MMN from preconception and life skills~     education among young women 15-24 years of age on the rate of low birth weight (LBW) in a~     population setting. Infants born to mothers enrolled in the study will be followed for 1~     year. This study aims to enrol 25,400 non-pregnant young women in Matiari district. This~     sample size is anticipated to equate to 1456 births. Participants will be randomized by~     cluster to receive either MMN supplements and life skills education or the standard of care~     at enrolment. Clusters have been defined based on health facility catchment areas. MMN~     supplements will be provided twice weekly during the preconception period, once daily during~     the pregnancy period, and once daily until 6 months after giving birth during the postpartum~     period; and a package of life skills education materials will be provided bi-monthly during~     the preconception period. In addition to the primary outcomes, measurements will include~     micronutrient status, anthropometrics, birth outcomes, dietary intake and feeding practices,~     adherence, and indices of empowerment.~   "
21328|NCT03287869|"~     This study will evaluate the safety and tolerability of brexpiprazole (OPC-34712) in the~     treatment of subjects with bipolar I disorder. All subjects will receive a starting dose of~     brexpiprazole which will be titrated up in subsequent visits.~   "
21329|NCT03287856|"~     The study investigates the technical feasibility of the replacement of failed surgical~     bioprosthetic aortic valves by the ALLEGRA Transcatheter Heart Valve (THV) and describes the~     safety and performance profile~   "
21330|NCT03287843|"~     This study aimed to compare the outcomes of early versus late surgical resection in patients~     who underwent curative total mesorectal excision after neoadjuvant chemoradiation. Half of~     the participants will undergo surgery before 8 weeks, while the other half will undergo~     surgery after 8 weeks.~   "
21331|NCT03287830|"~     This multi-site study assesses the impact of text message reminders on the receipt of the~     second dose of influenza vaccine, and takes place in practices from the American Academy of~     Pediatrics (AAP) Pediatric Research in Office Settings (PROS) network.~   "
21332|NCT03287817|"~     The purpose of this study is to test the safety and efficacy of AUTO3 a CAR T cell treatment~     targeting CD19 and CD22 followed by limited duration of consolidation with anti-PD1 antibody~     in patients with DLBCL~   "
21333|NCT03287804|"~     The purpose of this study is to test the safety and efficacy of AUTO2, a CAR T Cell Treatment~     Targeting BCMA and TACI, in Patients with Relapsed or Refractory Multiple Myeloma.~   "
21334|NCT03287791|"~     The objectives of this study were to compare the safety and efficacy profiles of a generic~     Azelaic Acid Foam, 15% to the reference listed Finacea® (azelaic acid) Foam, 15% and to~     demonstrate therapeutic equivalence and safety of the two active foams in the treatment of~     moderate facial rosacea, and to demonstrate superiority of the Reference and Test products~     over the Vehicle~   "
21335|NCT03287778|"~     Purpose: Tardive dyskinesia (TD) is a involuntary movement disorder that can occur following~     long term treatment with antipsychotic medications and for which few treatment options exist.~     This study will test the efficacy of pyridoxine (also known as vitamin B6) for TD. This will~     be an 8 week double-blind, placebo-controlled, randomized trial measuring the effect of~     pyridoxine 400 mg/day on the severity of involuntary muscle movements in people who meet~     Schooler-Kane criteria for TD.~      Participants: Approximately 50 subjects will be recruited from the UNC Schizophrenia~     Treatment and Evaluation Program (STEP) and other local psychiatric clinics.~      Procedures (methods): Symptoms of TD will be assessed using the Abnormal Involuntary Movement~     Scale (AIMS). Pharmacological Intervention: All participants who meet entry criteria will be~     randomized to one of two treatment groups: pyridoxine or placebo.~   "
21336|NCT03287765|"~     The purpose of this research study is to evaluate a new radioactive compound used in positron~     emission tomography (PET) scans in identifying tau tangles (a certain protein that might be~     associated with Alzheimer's disease) in the brain, and if the amount of tau tangles in the~     brain has a relationship to cerebrospinal fluid (CSF) biomarkers and cognitive status.~      This study involves a PET scans using the radioactive compound, F 18 T807 for measurement of~     tau deposition. This radioactive compound is not approved by the United States Food and Drug~     Administration (FDA). An MRI will be conducted if one has not been completed completed within~     the past 12 months under a related research study. Participants will be asked about their~     medical history, family history, surgical history, and current medications. We will evaluate~     history of traumatic brain injury (TBI) using the Ohio State University Traumatic Brain~     Injury Identification (OSU TBI-ID) Method. This will take approximately 10 minutes.~     Participants will be asked to undergo a Mini Mental State Examination (MMSE), which will last~     approximately 5-10 minutes.~      Additionally, participants may be invited to undergo optional brain PET imaging with~     2-deoxy-2-[18F]fluoro-D-glucose fludeoxyglucose (18F-FDG), for measurement of the cerebral~     metabolic rate of glucose consumption. At the time of the initial T807-PET study,~     participants will be asked if they are willing to undergo repeat T807-PET imaging at least 2~     years after the initial study. This follow up study is optional, and participation in the~     study and initial T807-PET imaging will not be contingent on agreeing to the 2-year follow up~     study.~   "
21337|NCT03287752|"~     The BASKA mask (Logikal Health Products PTY Ltd., Morisset, NSW, Australia) is a novel~     supraglottic airway device. It has many of the features of other supraglottic airways, with a~     number of innovations. These include; A non-inflatable cuff, that it is continuous with the~     central channel of the device. As the pressure increases with positive pressure ventilation,~     the cuff itself is 'inflated', this may improve the seal, reduce leak, and make ventilation~     more efficient.~   "
21375|NCT03287258|"~     Pregnant participants will be recruited at the obstetrics outpatient clinic during their~     visits 4 weeks before the due date. They are randomized into two groups. The first group will~     be educated to do digital perineal massage. They will be also educated to do pelvic floor~     muscle exercises and will receive the usual education program for strengthening the pelvic~     floor. The second group will receive the usual education program for strengthening the pelvic~     floor. Occurrence of perineal laceration will be reported at time of delivery.~   "
21376|NCT03287245|"~     This is an open-label, single-arm, study of idasanutlin monotherapy in participants with~     hydroxyurea (HU)-resistant/intolerant Polycythemia vera (PV).~   "
21338|NCT03287739|"~     Upper limb recovery after stroke is highly predictable early after stroke. Nijland et al.~     showed that based on two simple clinical bedside tests - 'Shoulder Abduction' and 'Finger~     Extension' (the so called 'SAFE model' [Stinear et al., 2012]) - measured within the first 72~     hours after stroke, ~87% of the patients could be correctly classified as either regaining or~     not regaining some dexterity (recoverers or nonrecoverers, respectively) (Nijland et al.,~     2010). This kind of information regarding the patients' functional prognosis allows proper~     discharge planning, setting realistic rehabilitation goals, and adequate patient information.~     However, the length of hospital stay after stroke has been decreasing. Therefore, knowledge~     is needed regarding the ability to make an accurate first prediction within the first 24~     hours after stroke onset while using simple clinical bedside assessments. This would~     facilitate an earlier triage and with that, an accelerated and smooth transition of patients~     within the stroke care continuum. In addition, a first prediction within 24 hours poststroke~     has the potential to decrease health care expenses, as length of hospital stay after an acute~     stroke is ~30% of the total costs (i.e., direct and indirect costs) associated with stroke~     (Roger et al., 2012; Fattore et al., 2012).~      The primary objective of aRISE is to determine the ability of the behavioral biometric~     impairments 'Shoulder Abduction' and 'Finger Extension' measured <24 hours poststroke to~     predict outcome of upper limb capacity 3 months after stroke. The secondary aim is to~     investigate the the added value of other simple clinical bedside tests for predicting outcome~     of upper limb capacity 3 months poststroke.~      aRISE is a prospective longitudinal observational cohort study of 40 first-ever ischemic~     stroke patients, who will be assessed <24 hours, 7 days and 3 months after stroke onset.~   "
21339|NCT03287726|"~     Weight loss maintenance is the biggest challenge in obesity management, with the majority of~     weight-reduced individuals experiencing weight regain. The intake of probiotics has been~     shown to help in weight loss, but its potential in maximizing weight loss maintenance remains~     unknown. Therefore, the main aim of this study is to investigate the impact of probiotic~     consumption on weight loss maintenance. Secondary aims are to investigate if the intake of~     probiotics influences gut microbiota, cardio-metabolic profile, appetite and inflammatory~     markers.~   "
21340|NCT03287713|"~     Objectives: 1.- To compare the level of oxygenation achieved during muscular training with~     conventional oxygen systems (nasal cannulas) versus nasal High-flow oxygen therapy. 2.-To~     compare benefits achieved with both systems, in terms of: level of exercise during training;~     effort tolerance in the 6 minutes walking test (6MWT); improvement of dyspnoea and~     Health-related quality of life (HRQoL). And analyse the effects of nasal High-flow oxygen~     therapy on the acute exercise in a subgroup of patients.~      Method: Multicentric randomized clinical trial. Patients with ILD in fibrotic phase who~     present oxygen desaturation during 6MWT (SpO2 mean ≤ 85%) will be included consecutively.~     Will be randomized in two groups: ILD patients with conventional oxygen (EPIDOC) and ILD~     patients with nasal High-Flow oxygen therapy (EPIDOAF). Both groups will perform a Pulmonary~     Rehabilitation Program. Oxygen will be titrated respectively to flow and FiO2 needed to~     maintain SpO2 ≥ 90% during training with both systems. Evaluation measures: SpO2 during~     training in both groups; dyspnoea (mMRC scale and CRQ dyspnoea); exercise capacity (6MWT) and~     HRQoL (self- administered KBILD questionnaire and SF36). In a subgroup of patients will be~     compared time of endurance exercise to evaluate the effects of nasal high-flow oxygen therapy~     in the acute exercise.~   "
21341|NCT03287700|"~     In the UK, cochlear implantation is the standard treatment for adults with~     'severe-to-profound' deafness. This level of deafness means that without a cochlear implant~     they have difficulty understanding what people are saying even when they wear hearing aids.~     The NHS provides a cochlear implant for one ear even though these adults are deaf in both~     ears. Two cochlear implants could help them understand speech in noisy environments, know~     where to look to see who is talking, and avoid hazards outdoors.~      The decision about who can receive cochlear implants and how many they can receive is based~     on guidance from the National Institute for Health and Care Excellence (NICE). NICE agreed~     that providing two cochlear implants can provide additional benefits over providing just one~     implant. However, they decided that there is not enough evidence to show that these~     additional benefits are worth the additional cost of providing the second implant. NICE~     recommended that a clinical trial should be conducted to gather this evidence.~      This study will consult with patients to explore whether the trial would be acceptable to~     future implant recipients. The study will also work with clinicians to design a trial~     comparing bilateral and unilateral implantation in adults. These clinicians will also be~     surveyed to assess the acceptability of the trial. A group of clinicians that span the range~     of professions involved in delivering the care pathway will be invited to attend a trial~     design workshop to establish a consensus on acceptable trial design elements from a clinical~     perspective. Representatives from cochlear implant manufacturers will be consulted to~     determine possible strategies for securing industry support for a future trial. Those who run~     cochlear implantation services will be engaged in a working group to gather information on~     the current care pathway to inform future assessments of whether bilateral implantation could~     be cost-effective.~   "
21342|NCT03287687|"~     Hypothesis:~      Carbon dioxide gas use for endoscopic insufflation is safe and results in less abdominal~     distension and discomfort; it is equally effective as air in pediatric patients undergoing~     endoscopic procedures.~      Aim 1:~      Determine the occurrence and severity of abdominal discomfort and distension associated with~     endoscopic procedures at baseline, upon awakening from anesthesia, at discharge and at 4~     hours after discharge in carbon dioxide group when compared to the air group.~      Aim 2:~      Determine if the expertise level of the endoscopist contributes to abdominal discomfort and~     distension following endoscopy, and whether this differs in the carbon dioxide group versus~     air group.~      Aim 3:~      Determine if carbon dioxide is as effective as air for insufflation.~   "
21343|NCT03287674|"~     Adoptive T cell therapy (ACT) with tumor infiltrating lymphocytes (TIL) has achieved~     impressive clinical results with durable complete responses in patients with metastatic~     melanoma. Recently, the investigators have completed a pilot study treating 6 patients with~     metastatic ovarian cancer. The TILs are isolated from patients own tumor tissue followed by~     in vitro expansion and activation for around 4-6 weeks. Before TIL infusion the patients~     receive 1 week of preconditioning chemotherapy with cyclophosphamide and fludarabine. After~     TIL infusion Interleukin-2 is administered to support T cell activation and proliferation in~     vivo.~      The investigators recent pilot study has shown TIL therapy in patients with metastatic~     ovarian cancer to be feasible and tolerable. Mainly transient clinical responses where~     observed and therefore the investigators plan to combine TIL therapy with checkpoint~     inhibitors to potentially increase the clinical effect.~   "
21344|NCT03287661|"~     The purpose of this study is to evaluate the efficacy of an online acceptance-based~     behavioural treatment for chronic pain designed for military, police, and veteran~     populations. Participants will be randomized into either the treatment condition, or the~     wait-list control condition, and asked to complete a battery of measures which underscore the~     key facets of the fear-avoidance model of chronic pain. The pre, post, and follow-up measure~     scores will be analyzed through the means of a 2 x 3 mixed model ANOVA which will assess the~     magnitude of changes between the treatment and wait-list control groups. The results will~     assist in establishing the effectiveness of the novel online treatment.~   "
21345|NCT03287648|"~     Some alterations of the foveal contour do not meet the criteria established for the~     definition of lamellar macular hole on the basis of optical coherence tomography (OCT).~     However, these alterations may show an appearance, on blue fundus autofluorescence (B-FAF)~     imaging, reminiscent of lamellar macular hole.~      The aim of the study is to evaluate in detail these alterations recording simultaneously OCT~     and B-FAF.~   "
21347|NCT03287622|"~     Millions of children and adolescents are prescribed opioid pain relievers each year, placing~     them at risk for serious adverse events and misuse in the home setting. Parents who manage~     these medicines, therefore, need to recognize opioid-related risks and make decisions that~     will both reduce these risks yet ensure effective pain relief for their children. The~     proposed research will evaluate new strategies to help parents learn about opioid risks, make~     safe and effective analgesic decisions, and develop and demonstrate safe drug management~     behaviors. 840 parents and their children who are undergoing an elective surgical procedure~     will be recruited. Parents will be randomized to receive the new educational and practical~     behavioral strategy or routine information. Parents' knowledge and perceptions will be~     evaluated at baseline and at critical times after surgery. Parents' opioid handling and~     administration will also be assessed.~   "
21348|NCT03287609|"~     Reduction of low-density lipoprotein cholesterol (LDL-C) levels effectively reduces the risk~     of adverse events in patients with established atherosclerotic cardiovascular disease. The~     clinical benefit of statins in improving clinical outcomes is proportional to the magnitude~     of LDL-C reduction, is more pronounced in patients with acute coronary syndromes (ACS)~     compared with stable coronary artery disease, and emerges at very early stages (as early as 4~     weeks) after ACS when statins are administered in the acute phase of the event. On the basis~     of this evidence, early initiation of statin therapy is currently recommended in patients~     presenting with ACS. Because many patients cannot achieve adequate reduction of LDL-C levels~     despite treatment with high doses of statins or non-statin lipid-modifying medications,~     substantial residual risk remains. Moreover, the time of onset of LDL-C reduction takes 2~     weeks following initiation of statin therapy. Proprotein convertase subtilisin/kexin type-9~     (PCSK9) inhibitors represent a novel class of lipid-lowering drugs leading to rapid,~     profound, and consistent reductions in LDL-C levels. While the effectiveness of PCSK9~     monoclonal antibodies for LDL-C lowering has been established across patient populations~     without atherosclerotic cardiovascular disease or with stable ischemic heart disease,~     reduction and attainment of LDL-C target levels has not been explored in the acute setting of~     ACS - a clinical setting with highest risk of early event recurrence (within the first~     month). In this study the investigators want to evaluate the safety and effectiveness of the~     PCSK9 inhibitor evolocumab as compared with placebo, administered in the acute phase of ACS,~     for reduction of LDL-C levels within 8 weeks in patients receiving guideline-recommended~     high-intensity statin treatment (atorvastatin 40mg QD).~   "
21349|NCT03287596|"~     The purpose of this study is to accurately map calcaneal fibrocartilage using TE = 0 ms~     imaging, and then apply measurements of our control population to SpA patients with~     peripheral enthesis study using the calcaneal tendon as a clinical model~   "
21350|NCT03287583|"~     Disordered gambling, like substance misuse, has been associated with various medical problems~     and adverse health outcomes. The Maryland Center of Excellence on Problem Gambling, along~     with experts in the fields of disordered gambling and behavior change, will work with the~     Maryland State Department of Health and Mental Hygiene's Behavioral Health Administration to~     develop a problem gambling-specific Screening, Brief Intervention and Referral to Treatment~     (SBIRT) intervention targeting individuals receiving medical care in general primary care~     clinics. The investigators will evaluate the feasibility and acceptability of inserting the~     problem gambling intervention in to preexisting substance use SBIRT services being provided~     in clinics in the state. In addition, the investigators will establish a clinic prevalence~     for gambling and finally, conduct a randomized trial using the problem gambling SBIRT~     intervention to see if it is effective in helping patients reduce their problematic gambling~     behaviors.~   "
21351|NCT03287570|"~     The purpose of this study is verify the efficacy and safety of Cettum (Electric moxibustion)~     for patients with knee osteoarthritis.~   "
21352|NCT03287557|"~     By doing this study, the investigator hopes to learn how the levels of important proteins~     involved in inflammation change over time in patients with acute brain injury. The total~     amount of time participants will be asked to volunteer for this study is approximately two~     hours over a five day period.~   "
21353|NCT03287544|"~     Linguistic training is traditionally the gold standard for rehabilitation of aphasia after~     stroke and efficacy criteria count early stage, intensity as well as personalized treatment.~     To date, no clear evidence showed a specific effect of any therapy in the acute phase of~     aphasia after stroke. This study aims to compare the effect of a combined therapy~     (linguistic/communication) versus a linguistic therapy on communication performance in~     patients in the acute phase of aphasia after a first stroke.~   "
21354|NCT03287531|"~     This study was to determine the effect of conventional therapy and low level laser therapy on~     pain and function in patients with temporomandibular joint dysfunction. sixty patients with~     myofascial pain syndrome of TMJ are randomly classified into two groups with thirty patients~     in each group; Group I received traditional exercise. Group II received low level laser~     therapy in addition to traditional exercise. All outcome measures including Pain and~     function, were evaluated before and after the treatment program.~   "
21355|NCT03287518|"~     The main objective of the study is to evaluate the endothelial function of WAK2017. In~     addition the effects on the blood pressure and the parameters of lipid metabolism will be~     explored.~   "
21356|NCT03287505|"~     This study assess pharmacokinetics and safety of single-administration of Aripiprazole IM~     Depot formulation at doses of 300 and 400mg in patients with schizophrenia.~   "
21357|NCT03287492|"~     The goal of this research study is to compare the use of new informational material with the~     regular informational material that is usually given to patients and caregivers to help them~     better communicate with their doctor.~      This is an investigational study.~      Up to 272 participants will be enrolled in this study. Up to 136 patients and 136 caregivers~     will take part. Up to 20 doctors will also take part. All will take part at MD Anderson.~   "
21377|NCT03287232|"~     The primary objective is to confirm the efficacy of intravaginal prasterone (DHEA) on~     Hypoactive Sexual Desire Disorder (HSDD) in postmenopausal women.~   "
21378|NCT03287219|"~     To describe and evaluate the mucosal staining efficacy of Methylene Blue MMX® tablets after~     total oral doses of 150 or 200 mg in patients undergoing a full colonoscopy for various~     reasons.~   "
21379|NCT03287206|"~     Intellectual deficiency (ID) is a veritable public health issue because it affects 1 to 3% of~     the population at large. Currently, in France, the diagnosis is based on clinical expertise,~     the use of DNA microarray analysis, screening for fragile-X syndrome and, if necessary, a~     study of target genes depending on the clinical data. Although clinical expertise is not~     enough to target one gene in particular, these different tools currently lead to diagnosis in~     only 20% of patients on average (higher percentage in cases of syndromic intellectual~     deficiency), sometimes after numerous expensive biological examinations.~      Thanks to high-throughput sequencing (HTS), medical genetics is experiencing a major~     technological upheaval, originating from the development of sequencing panels of target~     genes, such as, for example, the DI459 panel, composed of 459 genes implicated in or likely~     to be implicated in ID, developed by the team in Strasbourg and whole-exome sequencing (WES).~     The deployment of HTS in diagnosis has occurred at different speeds depending on the country,~     some of which have been using it in routine diagnosis for several years. The type of strategy~     to adopt in development anomalies is still a matter of debate in France, in the absence of~     results from cost-effectiveness analyses; this absence has hampered the implementation of~     these technologies.~      In the diagnosis of ID, the DI459 panel has a diagnostic yield of 25%. Data in the literature~     also show a high efficacy of WES in patients with ID: approximately 32% of genetic diagnoses~     (progressively increasing thanks to possible reanalysis as knowledge of genomics advances)~     and 10% of additional diagnoses through the identification of chromosomal~     micro-rearrangements, making an expected total of 42% of diagnoses. WES could thus replace~     array-CGH. The cost is higher than that for the DI44 and DI459 panels, but it means that~     examinations don't have to be repeated sequentially over time if the investigations are~     negative.~      The question of medico-economic value is thus central so as to determine which strategy is~     the most effective. A few medico-economic studies, comparing classical investigations with~     WES, have already been carried out concerning the use of HTS for diagnostic purposes, but~     none have concerned ID, or compared panel sequencing with WES. In this context, a~     medico-economic study is essential in France, because ultimately the choice of the most~     appropriate HTS strategy in the diagnosis of ID will have major repercussions not only~     clinical and economic, but also for society at large, on the one hand because of the benefits~     1) for the management and prognosis of patients, and 2) for families as they will have~     improved access to genetic counselling. It is important to note that the Genetic community~     has never experienced such a huge technological innovation, which will lead to a massive~     increase in diagnostic yield, thus justifying the interest that the community must give to~     this innovation.~   "
21416|NCT03286725|"~     Neuroscience evidence suggests that physical exercise can influence brain function and~     structure, both immediately and in the long-term. The 'Fit to Study' project is a randomised~     controlled trial to test the effects on academic performance (as well as fitness, wellbeing~     and cognitive function) of a teacher-training intervention designed to optimise the content~     of PE for brain and cognitive function during secondary school (Year 8) Physical Education~     (PE) lessons. The project aims to rigorously test the impact of this intervention in 100~     state-funded secondary schools.~   "
22014|NCT03278873|"~     This study is a longer-term follow-up study for patients who participated in a clinical trial~     of AAV - CNGB3 retinal gene therapy for patients with achromatopsia.~   "
21358|NCT03287479|"~     The GAVI® closed vitrification system is a CE labelled device licensed for use in human IVF.~     It has been developed to standardize the process of vitrification and to increase the safety~     of the procedure. It has been demonstrated that the novel semiautomated, closed vitrification~     system providing standardized equilibration prior to cryopreservation can produce similar~     results in terms of recovery rate and Embryo development up to the blastocyst stage as~     compared to the commonly used Manual Cryotop® open vitrifcation system when applied in a~     mouse model.~      Furthermore, its application has resulted in first pregnancies after transfer of~     vitrifiedwarmed biopsied human blastocyts. Due to limitations of the preliminary studies~     (application in mouse model; absence of a larger clinical Trial assessing pregnancy and live~     birth rates in human model etc.) it is of paramount importance to compare the GAVI®~     vitrification method to the routinely used Cryotop® method in a human IVF setting employing~     randomization and a-priori sample size definitions.~      The primary objective of this study is to demonstrate non-inferiority of vitrification using~     the semi-automated GAVI® closed system over the so-far routinely used manual Cryotop® open~     system in terms of post-thawing survival rate of 2PN oocytes.~      The secondary objective of this trial is to study differences in embryo development, clinical~     pregnancy rate, ongoing pregnancy rate and live birth rate.~      Furthermore, differences in procedure duration and convenience will be evaluated.~   "
21359|NCT03287466|"~     The investigators propose to conduct a feasibility, multi-centre, randomised controlled trial~     of targeted oxygen therapy in adult critically ill patients receiving mechanical ventilation~     via an endotracheal tube as part of their treatment for respiratory failure. Participants~     will be allocated to either a normal blood oxygen target group or a lower than normal blood~     oxygen target group. The primary purpose of the study will be to assess the feasibility of~     recruiting complex patients who lack capacity into a clinical trial in which oxygenation is~     being assessed, and that the clinicians responsible for these patients are able to deliver~     the intervention effectively. The safety of using a lower than normal blood oxygen target~     will also be assessed and blood samples taken for subsequent investigation of the biological~     mechanisms underlying the observed changes.~      Participants will be randomised (1:1) into either an intervention or control group. The~     intervention in this trial is tightly controlled administration of oxygen to patients to~     achieve a haemoglobin oxygen saturation (SpO2) of 88-92%. The control group will also have~     tightly controlled oxygen administration, but to achieve an SpO2 of 96% or above. The target~     for the control group represents a normal SpO2, whilst that in the intervention group is~     lower than what is considered to be normal. It should be noted that although lower than~     normal, this SpO2 is close to what the general public experience when travelling by~     pressurised aircraft as the fractional inspired oxygen concentration in that situation is~     only 0.15-0.17 (15-17%).~      The controlled oxygen administration would commence as soon as possible after admission to~     the critical care unit and end following removal of the participant's artificial breathing~     tube. The researchers and clinical team cannot be blinded to treatment allocation, due to the~     nature of the intervention. Those analysing the data will be blinded to the intervention.~   "
21360|NCT03287453|"~     This clinical trial studies how well educational intervention works in improving knowledge~     and screening rates of colorectal cancer. An educational intervention, such as viewing an~     inflatable colon, PowerPoint presentation, or flip books/flipcharts, may help improve~     knowledge about colorectal cancer and how often people get checked for colorectal cancers.~   "
21361|NCT03287440|"~     This study will examine COPD Wellness, a 10-week low-intensity pulmonary rehabilitation~     program consisting of group and home exercise, education, and social support can improve~     symptoms and increase physical activity in participants with COPD who receive care within a~     'safety-net' healthcare system (e.g. County Hospital). Half of the participants will also~     receive an adherence strategy targeted at addressing unmet social needs, while the other half~     will undergo the intervention without the adherence strategy.~   "
21362|NCT03287427|"~     The purpose of this research study is to look at the effects, good or bad, of TetMYB Vaccine~     in combination with BGB-A317 in patients with advanced or metastatic solid cancers (including~     colorectal or adenoid cystic cancer).~      The immune system is the body's defence against cancer, bacteria and viruses. TetMYB Vaccine~     is a vaccine that helps your immune system to recognise the cancer cells. BGB-A317 is an~     antibody (a type of protein made in the body in response to a foreign substance) that helps~     to stop or reverse the growth of tumour cells.~      Up to 32 participants may take part in this study, which is divided into 2 stages: dose~     escalation (different doses will be tested in small groups of patients) and dose expansion~     (one or more doses may be tested in a larger group of patients). Which stage you participate~     in will depend on which is open at the time. Your study doctor will discuss this with you.~      During dose escalation, study patients will receive increasing doses of the TetMYB Vaccine,~     starting at a low dose. During dose expansion, study patients will receive the dose~     determined as safe in dose escalation.~      The study design is as follows:~      In the dose finding stage, the first patient of each dose level will receive 6 consecutive~     weekly doses of intradermal TetMYB monotherapy for safety evaluation. If there are no~     reported DLTs, the next 2 patients of the same dose level will also receive 6 consecutive~     weekly intradermal doses of TetMYB, however with 3 weekly doses of BGB-A317 commencing with~     the fourth TetMYB dose. The dosage of TetMYB are as follows:~        -  Dose level 1: 100 ug in 100 uL of sterile dH2O containing 5% DMSO~        -  Dose level 2: 500 ug in 100 uL of sterile dH2O containing 5% DMSO~        -  Dose level 3: 1000 ug in 100 uL of sterile dH2O containing 5% DMSO.~      In the dose expansion stage, the dosage will be the maximum tolerated dose (MTD) identified~     in the dose-finding stage and in combination with BGB-A317.~      TetMYB Vaccine is being developed and manufactured by the Peter MacCallum Cancer Centre~     according to Good Manufacturing Practice (GMP) and in accordance with guidelines provided by~     the Food and Drug Administration (FDA) in the USA and Therapeutic Goods Administration (TGA)~     in Australia. TetMYB Vaccine is an experimental treatment and is currently not approved for~     use in any country. This means that it is not an approved treatment for cancer in Australia.~     This will be the first time that the TetMYB vaccine is given to humans.~      BGB-A317 is being developed by BeiGene, a biopharmaceutical company. BGB-A317 is an~     experimental treatment. This means that it is not an approved treatment for solid cancers in~     Australia.~   "
21363|NCT03287414|"~     This study will investigate the safety and efficacy of VAY736 administered subcutaneously~     (s.c.) every 4 weeks for 48 weeks. Approximately, 84 subjects will be randomized in a 1:1~     ratio on top of local standard of care (SOC), to receive VAY736 or placebo.~   "
21364|NCT03287401|"~     Aim of this observational study is to investigate whether frontal electroencephalogram~     analysis is able to predict increased risk for PACU delirium.~   "
21365|NCT03287388|"~     During laparoscopy, a surgical working space is obtained by creation of a pneumoperitoneum.~     Optimal surgical conditions are essential to ensure the patient's safety. A meta-analysis on~     studies comparing the influence of deep and moderate neuromuscular blockade (NMB) on the~     quality of the surgical space conditions during laparoscopy (1), showed that compared to~     moderate NMB, deep neuromuscular blockade improves the surgical space conditions, assessed by~     the Leiden-Surgical Rating scale, as reported by Martini and colleagues (2).~      In this prospective cohort study, we will assess the influence of deep neuromuscular blockade~     on the surgical space, measured by magnetic resonance imaging (MRI) in patients scheduled for~     laparoscopic donor nephrectomy, laparoscopic cholecystectomy or laparoscopic colectomy.~   "
21366|NCT03287375|"~     This is a study, where the efficacy of Pressurized IntraPeritoneal Aerosol Chemotherapy~     (PIPAC) against peritoneal metastases will be evaluated. Furthermore, this study will focus~     on the best evaluation method, where both Quality of Life questionnaires, repeated histology,~     cytology and MRI will be used.~   "
21814|NCT03281512|"~     The role of saturated fatty acids (SFAs) intake in the development of total death,~     cardiovascular diseases, diabetes, hypertension and overweight are in great controversy but~     evidence from large population in China is scant.The investigators aim to use the data from~     the China Health and Nutrition Survey to assess the long-term association of SFAs intake with~     total mortality, diabetes, hypertension and overweight.~   "
21367|NCT03287362|"~     The MPI-PT-Study: Schema Therapy vs. Cognitive Behavioral Therapy for Patients with Major or~     Persistent Depressive Disorder in an Inpatient and Day Clinic Setting: An outline~      Depressive disorders represent one of the most frequent diseases worldwide. Schema therapy,~     which was originally developed for patients with personality disorders and focuses on emotion~     activating techniques, became popular in the field of psychotherapy in the recent years and~     was also applied on axis-I-disorders such as depression.~      The current study aims to close the gap of increasing popularity of ST and missing empirical~     evidence of its effectiveness. This aim breaks down into three main research questions~     dealing with (1) general effectiveness of ST measured by multiple operationalizations (i.e.~     depressive symptoms, biological markers, relapse prevention, or need for medication), (2)~     specific effectiveness of ST (i.e. interpersonal problems and emotion regulation), and (3)~     the identification of parameters in the sense of an individualized psychotherapy approach in~     order to fit patient needs with certain psychotherapy offers.~      After participants have given informed consent, they undergo a comprehensive baseline~     measurement which covers psychometric measures (such as questionnaires and clinical ratings),~     biological parameters (blood samples, endocrine activity), neuropsychological testing (such~     as word fluency), and actimetry measures (circadian rhythms).~      After finishing the diagnostic procedure, participants will be randomized to three different~     experimental conditions: (1) a schema therapy condition, (2) a cognitive behavioral therapy~     condition, and (3) an individualized supportive therapy condition. After undergoing a~     comprehensive baseline measurement process in study week one, patients participate in an~     intensive seven-week-treatment-program, in addition to the regular pharmacological treatment,~     which is not object of the study. The measures are repeated during the fourth and seventh~     week of psychotherapeutical treatment and on the occasion of a follow-up visit six months~     after discharge from the clinic.~      Additionally, the investigators test among sub-samples the effects of psychotherapeutical~     interventions on psychophysiological outcomes, sleep-patterns, and neuronal substrates in the~     context of emotional regulation and social interaction.~      Thus, the study will give valuables insights in the effectiveness of an innovative~     psychotherapy approach and breaks new ground in the field of individualized psychotherapy and~     its biological implications.~   "
21368|NCT03287349|"~     Determine an underlying etiology behind unexpectedly severe reactions to radiation by blood~     draw.~   "
21369|NCT03287336|"~     Postpartum hemorrhage is a significant contributor to maternal morbidity and mortality and is~     worldwide. TXA has recently been proven to reduce mortality when given to women in setting of~     diagnosed PPH. US obstetricians and anesthesiologists are hesitant to use TXA in the~     peripartum period especially for prevention of PPH due to uncertainty of an optimal dose and~     safety profile. The purpose of this study is to characterize the pharmacokinetics of TXA when~     given prophylactically at time of delivery. In addition investigators will determine the~     pharmacodynamics of TXA in the peripartum period.~   "
21370|NCT03287323|"~     Patients will be identified according to pre-defined trigger criteria for a palliative~     intervention. One hundred patients of a control group will receive standard intensive care~     treatment (Usual Care Group). Patients' biopsychosocial problem-related distress will be~     evaluated and family satisfaction with intensive care will be measured with standardized~     questionnaires. In the subsequent intervention part of the study one hundred patients will~     additionally be offered a palliative care treatment (Proactive Care Group) and patients'~     biopsychosocial problem-related distress as well as family satisfaction will also be~     evaluated.~   "
21371|NCT03287310|"~     GSK3511294 is a humanized monoclonal antibody antagonist of Interleukin (IL)-5 which is known~     to block binding of IL-5 to the IL-5 receptor complex, causing a reduction in the circulating~     population of eosinophils. This is a single ascending dose FTIH study to investigate safety,~     tolerability, immunogenicity, pharmacokinetics (PK) and pharmacodynamics (PD) of GSK3511294,~     administered SC in subjects with mild to moderate asthma maintained on a low-medium daily~     dose of inhaled corticosteroids (ICS) or ICS/long acting beta-agonist (LABA), and short~     acting beta-agonist (SABA). The subjects will attend a pre-screen visit of up to 12 weeks~     before dosing for assessment of blood eosinophils. Eligible subjects with blood eosinophils~     >=200 cells per microliter (cells/µL) will undergo a screening period of up to 4 weeks. The~     subjects will then be randomized into 5 cohorts. In each cohort, the subjects will be~     randomized to receive a single dose of GSK3511294 or placebo in a ratio of 3:1. The follow-up~     period will be up to 40 weeks post dose and will be dose-dependent. The scheduled maximum~     duration for each subject will be up to 44 weeks including up to 28 days of screening.~   "
21372|NCT03287297|"~     Gestational diabetes mellitus (GDM) is defined as carbohydrate intolerance of varying~     severity with onset or first recognition during pregnancy. The diagnosis of gestational~     diabetes is important, because of the increased risk of adverse maternal and feto-neonatal~     outcomes. In addition, GDM also confers a future risk of type 2 diabetes to mothers and their~     fetus. Dietary components associated with GDM risk include macronutrients, micronutrients,~     and individual foods, such as refined carbohydrates, saturated fats, soft drinks and~     processed meats. The Pre-pregnancy dietary patterns may affect women risk of developing GDM.~     A diet high in red and processed meat was associated with a significantly elevated risk.~   "
21373|NCT03287284|"~     Phototherapy has been largely used in rehabilitation programs due to its analgesic,~     antiinflammatory and healing effects. Lately, its effects of optimizing the results of~     resistance training on young individuals have been studied. However, there is a lack of~     studies on its effect on the elderly population. The objective of the present study is to~     verify the effect of Low-Level Laser Therapy (LLLT) on the results of resistance training in~     the elderly. The study will be a randomized doubled-blinded controlled trial. 30 elderly men~     with age ranging from 60 to 80 years will be included and randomized between Placebo Group~     (placebo LLLT + Resistance Training) and LLLT Group (active LLLT + Resistance Training). All~     volunteers will be submitted to a control period of four weeks before the beginning of the~     resistance training, which will have 12 weeks of duration. The assessments will be done at~     baseline, after the control period and after the training period. The training sessions will~     be performed twice a week and the training protocol will be performed with repetition maximum~     periodization. The LLLT will be applied before the training sessions on eight points of the~     quadriceps muscles, leading to a total of 240 Joules on each leg. The placebo LLLT will be~     applied on the same way, but with the equipment turned off. The assessments will include~     muscle architecture by ultrasonography, muscle strength by isokinetic dynamometer and 1~     Repetition Maximum test of leg-extension and leg-press exercises, and functional capacity by~     the 6-Minute Walking Test, 30s Sit to Stand Test, Timed Up-and-Go Test and Stair Ascent Test.~   "
21374|NCT03287271|"~     The purpose of the study is to investigate the combination VS-6063, carboplatin, and~     paclitaxel. in the treatment of patients with ovarian cancer. The study will evaluate whether~     this regimen is safe. The study will also evaluate whether the regimen can reduce the amount~     of cancerous cells in your body. If you agree, you will be treated with VS-6063 by mouth, as~     well as carboplatin and paclitaxel infusions. Carboplatin and paclitaxel are approved by the~     FDA for the treatment of ovarian cancer. VS-6063 is considered experimental because it is not~     approved by the FDA for the treatment of cancer.~   "
21380|NCT03287193|"~     Developmental diseases include more than 3000 diseases and can associate organ malformation,~     dysmorphism, development disorders and/or intellectual deficiency. Even though the~     considerable effort in the search for genes in the last 20 years has led to the~     identification of thousands of genes associated with Mendelian diseases, half of the~     individuals with severe development anomalies remain without a genetic diagnosis. It is~     important to pursue the ambition to contribute to the goal fixed by Europe, namely the~     identification of the large majority of genes responsible for rare diseases with development~     anomalies, and to be able to provide genetic counselling to patients and their families. In~     the past, scientific research to discover genes required a large number of families and~     individuals and was slow and expensive to carry out. Today, this approach has been~     facilitated by next generation sequencing.~   "
21381|NCT03287180|"~     The study assesses whether adding a behavioral intervention, known as the Adolescent~     Community Reinforcement Approach (A-CRA), to the treatment of individuals already receiving~     buprenorphine/naloxone can improve treatment success and retention rates in young adults with~     severe opioid use disorder.~   "
21382|NCT03287167|"~     This study is to assess the clinical non-inferiority of 1 month (short-term) vs 6 months~     (long-term) of dual anti-platelet therapy in patients undergoing percutaneous intervention~     implanted sirolimus -eluting stent with abluminal grooves containing a biodegradable polymer~     in High Bleeding Risk patients with coronary artery disease.~   "
21383|NCT03287154|"~     The aim of the study is to evaluate in patients with alcohol disorder and forehand weaned the~     efficiency of 10 active tDCS sessions versus 10 sham (placebo) sessions in the support of~     abstinence at 3 months.~   "
21384|NCT03287141|"~     Introduction: Dyspnea and fatigue are the main clinical symptoms of heart failure and~     primarily responsible for exercise intolerance found in this syndrome. Now, It is known that~     the use of NIV in CPAP mode applied before exercise increases exercise tolerance in people~     with heart failure; however, it's not yet known if the bi-level mode is able to generate~     similar or even better results, due to pressure increase of the ventilatory support in this~     modality. Moreover, it is possible that there is influence between the pressure levels set in~     the NIV and the magnitude of its effect on the exercise in this population Objective: 1) test~     for differences between the acute effects of NIV on exercise tolerance in patients with HF,~     when applied CPAP or bi-level mode; and 2) check for discrepancies in the acute effects of~     Bi-level mode on the physical performance of these individuals, when applied at different~     pressure levels. Methodology: This is a controlled, randomized, double-blind and cross-over~     clinical trial, to be composed of 45 volunteers of both genders, aged between 30 and 80~     years, with chronic heart failure, functional class II and III (New York Heart Association)~     in clinical stability. The experiment will be carried out on four different days, with a~     48-hour interval between them, in which NIV will be used in the following modes: Bi-level~     with minimum parameters (EPAP = 6 cmH2O and IPAP = 12 cmH2O), Bi-level with maximum~     parameters EPAP = 8 cmH2O and IPAP = 14 cmH2O) and CPAP (6 cmH2O). Thus, all the volunteers~     will participate in the four TGC. During the tests, distance walking, perceived levels of~     fatigue and dyspnea, affective response, as well as other physiological variables will be~     analyzed. Statistical analysis, the ANOVA test for repeated measurements will be used,~     followed by the Bonferroni post-test, considering p-value less than or equal to 0.05 as~     statistically significant. Expected Results: This work is expected to improve the therapeutic~     management of HF patients, assisting in the implementation and improvement of methods to~     improve dyspnea and muscle fatigue, thus increasing tolerance to exercise.~   "
21385|NCT03287128|"~     Gemtuzumab Ozogamicin/Mylotarg® (GO) is a conjugate of a derivative of calicheamicin a potent~     antitumor anthracycline antibiotic linked to a recombinant humanized antibody against the~     CD33 antigen. Pivotal phase 2 study in relapsed AML adult patients used GO 9 mg/m2 as a~     monotherapy on days 1 and 14, and showed a 30% response rate with half CR and CRp (CR with~     incomplete platelets recovery). Four randomized studies, 3 in adults and 1 in children,~     performed in patients with non-previously treated AML tested the addition of lower doses of~     GO ( 3mg or 6 mg/m2) to standard induction chemotherapy and showed benefit on survival~     endpoints. Results from these studies were available in 2011 in adults and 2014 in children.~     In 2010 the french health agency (ANSM) opened a compassionate patient named program~     (authorization for temporary utilization (ATU) program) of GO in relapsed/refractory AML~     patients. Patients were orally informed about the status of the GO. From 2010 to 2012 it was~     recommended to use GO as a monotherapy at a dose of 9mg/m2 on days 1 and 14 according to the~     protocol used in pivotal phase 2 study. After 2012 it was recommended by the health authority~     to use GO at the dose of 3 or 6 mg/m2 in addition to chemotherapy regarding the toxicity of~     higher dose given once.~      From 2010 to 2015 more than 500 AML patients have been included in this ATU program.~      The main objective of the study presented here is to assess the efficacy and safety of GO 3~     or 6 mg/m2 (single dose or fractionated GO) given in as treatment of relapsed/refractory AML~     in adult patients.~      The coordinator choose to collect the data from centers that included 10 patients or more~     from January 2012 to December 2015.~      This represents approximately 420 patients from 33 hematology departments.~   "
21386|NCT03287115|"~     The objectives of the study are 1) to characterize plasma and urinary metabolites that~     originate from glucobrassicin, 1-methoxyglucobrassicin, 4-methoxyglucobrassicin, and~     4-hydroxyglucobrassicin, which are the major indole glucosinolates found in broccoli, and 2)~     to identify novel plasma and urinary metabolites following broccoli consumption that may have~     roles in reducing the risk of cancer.~   "
21387|NCT03287102|"~     Since 1991, idiopathic macular holes (MH) can benefit from an effective treatment initially~     involving pars plana vitrectomy, stripping of epiretinal membranes and intraocular gas~     tamponade followed by facedown positioning. The initial 58% success rate has further~     increased to 85-100% with internal limiting membrane (ILM) peeling. However, complete ILM~     removal has been shown to lead to anatomic changes causing the retina to have the appearance~     of a dissociated optic nerve fiber layer (DONFL). Moreover, it has been associated with~     decreased retinal sensitivity that may cause visual discomfort despite good visual acuity.~     Nawrocki et al. recently suggested to reduce the area of peeled ILM (temporal inverted ILM~     flap technique) in order to minimize iatrogenic trauma while maintaining satisfactory~     surgical outcomes. The aim of this study is to compare the incidence of DONFL appearance and~     retinal sensitivity after macular hole surgery in eyes that underwent temporal inverted ILM~     flap technique and eyes that had complete ILM peeling~   "
21412|NCT03286777|"~     Micellar encapsulation will be tested to increase the oral bioavailability in humans of~     6-prenylnaringenin (6-PN) from hops (Humulus lupulus). The study follows a single dose (250~     mg 6-PN), placebo controlled, randomized, double-blind, three armed crossover study design~     with ≥2-week washout periods. Plasma, urine and PBMC samples will be collected at intervals~     up to 24 h after intake of the native compound, the micellar formulation or placebo. The~     safety, pharmacokinetics and impact of oral prenylflavonoids on PBMC survival will be~     investigated.~   "
21388|NCT03287089|"~     The specific aim of this randomized double-blind placebo-controlled trial is to evaluate the~     efficacy of administration of nitrofurantoin prophylaxis after catheter discontinuation for~     the prevention of catheter-associated urinary tract infections in patients with postoperative~     short-term catheterization following pelvic reconstructive surgery and/or urinary~     incontinence surgery.~      Patients that undergo pelvic organ prolapse and/or urinary incontinence surgery and fail~     their post-operative voiding trial will be included in the study. Upon successfully passing~     and in-office voiding trial at the time of catheter removal, they will be randomized to~     either nitrofurantoin 100mg twice daily or an identical appearing placebo capsule twice daily~     for 5 days following catheter removal. The primary outcome will be the treatment of~     clinically suspected and/or culture-proven UTI within 30 days of surgery. Secondary outcomes~     include adverse events associated with nitrofurantoin use and medication compliance.~      Primary and secondary outcomes will be evaluated with Student t test and chi squared or~     Fisher exact test as appropriate. Assuming a decrease in symptomatic UTIs attributable to~     nitrofurantoin prophylaxis from 32% to 14%, with 80% power, and a two-sided alpha of 0.05,~     and a 10% dropout rate, we should recruit a total of 180 patients.~   "
21389|NCT03287076|"~     Overview: Elevated blood glucose levels are common in many acute diseases, resulting in worse~     clinical outcomes. Hyperglycaemia in acute ischaemic stroke (post-stroke hyperglycaemia~     [PSH]) occurs in up to 50% patients, reduces the efficacy of stroke thrombolysis with~     increased risk of haemorrhage, increases infarct size, and results in worse clinical outcomes~     and death. Insulin-based therapies have not proved beneficial in treating PSH: they are~     difficult to implement and maintain, cause frequent hypoglycaemia, may cause increased~     infarct size, and do not reduce mortality or improve clinical outcomes. An alternative,~     simple to use, treatment for PSH may therefore have a significant impact not only for acute~     stroke care, but in other acute diseases.~      Pilot data: Exenatide is a commonly used diabetes drug (a synthetic glucagon- like peptide-1~     receptor agonist) that increases insulin secretion. Importantly, this action is glucose~     dependent - as blood glucose levels decrease, its stimulatory effect on insulin secretion~     subsides, with a very low risk of hypoglycaemia. A small randomised pilot study of 17~     consecutive, unselected patients (ie. regardless of their admission glucose level) with acute~     ischaemic stroke compared subcutaneous exenatide 5μg for 5 days with routine standard of~     care. Overall, blood glucose levels remained consistently lower (and less variable) in the~     exenatide group, and most noticeably in those stroke patients with known diabetes. Exenatide~     was safe and well tolerated by all patients, with no symptomatic hypoglycaemia.~      Trial design: TEXAIS is a 3 year Phase 2, multi centre, prospective, randomised, open label,~     blinded end-point (PROBE) trial comparing Exenatide to Standard of Care. The sample size is~     528 patients (264 in each arm).~      Intervention: Treatment arm will receive Exenatide (Byetta) 5μg subcutaneously twice daily~     for five days, commencing within 9 hours of symptom onset. Stroke onset time for wake-up~     strokes is taken as mid-point between going to bed, and waking up. Antiemetic therapy~     (metoclopramide or ondansetron) will be commenced with the first dose of Exenatide. In~     patients receiving tPA, Exenatide will be given alongside, or as soon as possible, following~     tPA administration (within 60 minutes). Diabetic patients already on oral agents and/or~     insulin may continue these (as per standard practice) in addition to Exenatide. Continuous~     glucose monitors (CGMs) will track the intra-day dynamic variability of glucose in acute~     stroke.~      Translation: TEXAIS is a simple, practical, study that can enrol all patients with ischaemic~     stroke, regardless of admission blood glucose level, regardless of stroke severity, with no~     target glucose level, and with low risk of hypoglycaemia.~   "
21390|NCT03287063|"~     Glioblastomas (GBM) demonstrate in vivo genetic and histologic heterogeneity that can be~     non-invasively identified using imaging phenotypes that identify regionally distinct areas of~     tumor with genetic alterations that drive tumor resistance pathways. The researchers propose~     a unique approach to assess initial GBM heterogeneity by performing histological and genomic~     analysis of biopsies targeted by advanced MRI before treatment.~   "
21391|NCT03287050|"~     This is a feasibility trial of anti-PDL1/PD1 (pembrolizumab) and stereotactic body radiation~     therapy (SBRT) in patients with advanced, platinum-refractory urothelial carcinoma.~   "
21392|NCT03287037|"~     The study aimed to investigate whether transcranial direct current stimulation could improve~     depressive symptoms, neurocognitive function and modulate heart rate variability in unipolar~     and bipolar depression.~   "
21393|NCT03287024|"~     Objective of the study is to assess safety and performance of the BeGrow Stent System for~     newborns and infants in pulmonary artery stenosis.~   "
21394|NCT03287011|"~     Plaque accumulation on tooth and gingival surfaces is a causative factor for oral diseases~     such as demineralization, dental caries, gingivitis, and periodontitis.~      Tooth brushing and flossing have been the cornerstone of oral hygiene and health. However,~     the high incidence and prevalence of gum problems in both the developed and developing world~     show these mechanical routines are not enough. Furthermore, many patients find it difficult~     to comply with this daily regime of brushing and flossing. Consistent with problems~     associated with maintaining oral health, periodontal disease is one of the most common~     chronic infections in adults. According to Philstrom, et al. up to 90% of the world's~     population has or will suffer from periodontal disease.Thus, the maintenance of an adequate~     level of plaque control by the individual through his or her daily oral hygiene is vital to~     prevent and control periodontal disease. Studies demonstrate that poor oral hygiene is~     widespread with about 60% of plaque found on the surfaces of the teeth after brushing. This~     may be due to the lack of manipulative skills, lack of motivation and compliance.Hence,~     increasing education and improving brushing technique by improving oral hygiene products is~     one way to enhance plaque removal in everyday brushing. The ability to see plaque while~     brushing will enhance patient's awareness and encourage them to be more thorough when~     performing oral hygiene.~   "
21395|NCT03286998|"~     A total of 60 women pregnant more than 28 weeks gestation will be recruited from obstetric~     outpatient clinic (faculty of medicine -Cairo University Hospital) after being diagnosed of~     having placenta previa or low lying placenta by grey scale ultrasound. Placenta will be~     reexamined by grey scale ultrasound & color Doppler. Sonographic parameters evaluated will~     include placental location, loss of retro-placental clear zone, irregularity and thickness of~     the uterine-placental interface, the smallest myometrial thickness in sagittal and transverse~     planes, presence of lacunar spaces and bridging vessels & the presence of abnormal~     vasculature. The sonographic findings will be compared with intraoperative ones. Hysterectomy~     specimen (if any was done) will be evaluated histo-pathologically to assess the degree of~     placental invasion & to confirm the accreta status. The aim of the study is to determine the~     efficacy of ultrasound in predicting operative findings and associated co-morbidties among~     cases of placenta accreta.~   "
21413|NCT03286764|"~     The investigators hypothesize that spraying peppermint oil containing L-menthol onto the~     colonic mucosa during colonoscopy will relax smooth muscle allowing better colonic~     visualization.~   "
22015|NCT03278860|"~     The main aim of the study is to investigate whether intranasal oxytocin (24IU) can enhance~     hedonic experience and associated brain-reward reward responses to social touch.~   "
21396|NCT03286985|"~     Deep venous thrombosis (DVT) represents a major problem in intensive care unit (ICU)~     patients. Despite the use of recommended pharmacological prophylaxis with low molecular~     weight heparin (LMWH), the incidence of DVT during ICU stay has been reported between 5 and~     15 %. The incidence may vary due to many factors, for example the type of ICU population, the~     type of protocol of pharmacological prophylaxis and also the type of diagnostic approach.~     Before formerly planned clinical study targeted to lower DVT incidence by individualizing the~     dose of LMWH, the investigators decided to evaluate the real DVT incidence in the~     investigated ICU. The prevalence and incidence will be assessed by ultrasound testing in~     general ICU patients. on the sample of 200 patients. The investigators hypothesize DVT~     incidence of 5 %. The compliance to the local DVT prophylaxis protocol will be also~     evaluated.~   "
21397|NCT03286972|"~     The purpose of this study is to evaluate this new technology available at the University of~     Wisconsin Carbone Cancer Center in the setting of head and neck cancer radiation treatment~     planning. This study will also provide preliminary data critical to the development of~     multi-parametric, multi-modality quantitative imaging biomarkers and data analysis models for~     prediction of outcome in both tumors and normal tissue, which are essential for~     patient-specific adaptive therapy.~      All participants will undergo a diagnostic PET/CT and a Radiation Treatment Planning CT per~     SOC procedures. In addition, all participants will undergo an additional imaging set~     consisting of a PET/MRI. It is anticipated that most patients will undergo the PET/MRI on the~     same day as their PET/CT negating the need for a second injection of the FDG radioisotope~     used for SOC PET imaging. All patients will receive gadolinium contrast per SOC dosing~     guidelines for the MRI portion of the PET/MRI. Both SOC MMRI pulse sequences and~     investigational sequences will be utilized in this study.~   "
21398|NCT03286959|"~     Aim of the study was to determine the effectiveness of cavity liners regarding survival of~     restoration beneath composite restoration after partial caries removal in permanent teeth~     with deep caries and to evaluate and compare the pulp vitality outcome both clinically and~     radiologically with and without liners.~      Study was conducted in Post Graduate Institute of Dental Sciences, Rohtak in department of~     Conservative Dentistry & Endodontics. Mature permanent mandibular molars with deep dentinal~     caries and without any signs of irreversible pulpitis were included in the study. After~     partial excavation of caries, patients were randomly allocated into three groups- RMGIC, CH~     and DIRECT COMPOSITE group and were restored according to standard protocol.~   "
21399|NCT03286946|"~     This study evaluates the incidence of intravascular injection during cervical transforaminal~     epidural block using blunt needle, compared to the sharp needle. The investigators will~     performed cervical transforaminal epidural block using blunt-type block needle in half of~     participants or sharp-type block needle in the other half.~   "
21400|NCT03286933|"~     The purpose of the study is to better understand the effects of a yoga program on adolescents~     with juvenile idiopathic arthritis (JIA). The investigators want to learn whether or not a~     yoga therapy based program will decrease pain and improve quality of life in patients with~     JIA.~      This is an 8-week program with home program of online videos.~   "
21401|NCT03286920|"~     This clinical trial is designed to be a multi-center prospective observational study which~     shall compare the effect of different postoperative home nutrition modes on recent~     nutritional index (weight/BMI) of patients with esophageal cancer and recent outcomes.~     Different postoperative home nutrition modes adopted in this study includes oral natural~     diet, oral nutrition supplement and tube feeding.~   "
21402|NCT03286907|"~     Objectives:~      To evaluate efficacies of two online and theory-based interventions [HC: health communication~     only and HC-MI health communication plus motivational interviewing (MI)] in increasing uptake~     of three doses of HPV vaccines within the 9-month follow-up period among Hong Kong Chinese~     men who have sex with men (MSM).~      Hypothesis:~      The HPV vaccination rate of the three groups would be in the order HC-MI group > HC group >~     Control group.~      Design and subjects:~      A three-arm randomized controlled trial (RCT) will be conducted (n= 624). With informed~     consent, anonymous surveys will be conducted at baseline, Months 3, 6, and 9. Inclusion~     criteria: 1) HK Chinese men aged >18, 2) oral or anal intercourse with men in the last six~     months; 3) no intention to leave HK for one month consecutively within the next 12 months, 4)~     regular internet access, and 5) willing to be followed up by phone.~      Study instruments:~      Structured questionnaires~      Interventions:~      1) Group HC: exposure to web-based, interactive and theory-based health communication~     promoting HPV vaccination uptake; 2) Group HC-MI: same exposure as Group HC plus MI; and 3)~     Group C: exposure to online materials about mental health (control group).~      Main outcome measures:~      Uptake of three doses of HPV vaccination within the follow-up period.~      Data analysis and expected results:~      Intention-to-treat analysis, General Estimation Equation (GEE) and Cox regression methods~     will be used. Significance differences in HPV vaccination uptake rates will be found among~     the three groups.~   "
21403|NCT03286894|"~     The AQUA© questionnaire developed in 2008 is a validated tools for the screening of allergic~     diseases in adult athletes. The objective of the present study is to develop and validate a~     modified version of the AQUA© questionnaire to be used in childhood. In this phase, the~     validation is intended to assess the reliability of the information collected through the~     AQUA© modified version: question difficulty and response patterns with respect to children~     characteristics (in particular age, sex and physical activity). In particular, the focus will~     be on the core questions, i.e. the indicators of allergic disorders. This is a~     cross-sectional study on 248 healthy schoolchildren aged 8 to 14 years.~   "
21404|NCT03286881|"~     The present work aims to develop a randomized clinical trial with a sample of 165 patients~     diagnosed with an emotional disorder. All participants are tested by several self-reports~     related to common mental disorders in a repeated measures design, pre and post treatment as~     well as a six month follow up. We think this study will demonstrate that brief psychological~     treatments should be prioritized over pharmacological treatment for such pathologies in the~     Primary or Secondary Care context to improve the patient´s quality of life while~     simultaneously reducing costs.~   "
21928|NCT03280004|"~     This research is to evaluate the effect of different antibiotics (Moxifloxacin Hydrochloride~     and Sodium Chloride Injection vs. β-lactam antibiotics for injection +/- Azithromycin for~     Injection) on the early deterioration or progression (<72 h of treatment) of community~     aquired pneumonia and to study the effect of the early deterioration or progression on the~     progonosis of community aquired pneumonia.~   "
21405|NCT03286868|"~     Total Knee Replacement (TKR) is an operation to help with the pain and decreased function~     that happens with end stage arthritis of the knee. This operation has been shown to be very~     successful at relieving pain and improving patient mobility; however, some studies have shown~     that up to 20% of TKR recipients are not happy with their knee replacement.~      All of the reasons why some patients are not pleased with the outcome of surgery are not~     known, but one of the possible causes is the way the implants are placed, or aligned, during~     surgery. Most TKRs are aligned in a fashion that the bones in the leg are completely straight~     after surgery. This is known as mechanically aligning a TKR. A different alignment method~     known as kinematic alignment respects the natural bow legged or knock kneed alignment of the~     patient. It is hoped that kinematically aligning a knee replacement will improve how the knee~     feels to the patient and therefore improve their satisfaction.~      Another potential factor affecting the outcomes of TKR is obtaining optimal soft tissue~     balance. The challenge with balancing a TKR is that traditional operative techniques rely on~     subjective feel of the knee stability during surgery. The balance or tension in the knee can~     however be objectively measured using specialized intraoperative pressure sensing devices.~      The purpose of this study is to assess the impact of kinematically aligned TKR on the~     pressures measured by Verasense during total knee replacements. The study will also determine~     if differences in the pressure measured during TKR surgery impact patient outcomes after~     surgery.~   "
21406|NCT03286855|"~     When patients get an attack of COPD, one of the main treatments is regular nebulised~     medications called bronchodilators. These medications act by opening up the airways allowing~     patients to breathe easier and to reduce shortness of breath. Newer nebulisers may increase~     the amount of medication that gets into the lungs compared to the standard nebuliser usually~     used in hospital. This study is being done to assess whether increasing the amount of~     medication getting into the lungs using these newer nebulisers will help patients recover~     from a COPD exacerbation.~   "
21407|NCT03286842|"~     This open label, multi-centre phase IIIb study will assess the effectiveness, benefits and~     potential harms in the use of olaparib monotherapy treatment for patients with HER2-ve~     metastatic breast cancer associated with Germline breast cancer susceptibility gene~     (gBRCA1/2) mutations.~   "
21408|NCT03286829|"~     A randomized, open-label, single-dose, parallel-arm, Phase 1 study to investigate the~     pharmacokinetic profile of a fixed-dose combination tablet of tesofensine and metoprolol~     (Tesomet) and co-administration of tesofensine plus commercial metoprolol in adult healthy~     subjects~   "
21409|NCT03286816|"~     Patients with type 1 diabetes (T1DM) who are unable to perceive symptoms of hypoglycemia,~     referred to as impaired awareness of hypoglycemia (IAH), are at very high risk of severe~     hypoglycemia. IAH affects approximately 25% of patients with T1DM. Brain lactate may be~     involved in the development of IAH. A recent study indicated increased brain lactate~     utilization during hypoglycemia in T1DM patients with IAH, which did not occur in patients~     with normal awareness of hypoglycemia (NAH). Conversely, administration of lactate to~     patients with NAH has been shown to attenuate counterregulatory hormone responses to and~     symptomatic awareness of hypoglycemia, thus causing a situation that resembles IAH. It has,~     however, not been demonstrated whether the excess of lactate is actually taken up or~     metabolized by the brain, and if so whether this occurs under euglycemic or hypoglycemic~     conditions or both.~      This project consists of two related studies. The objective of part 1 is to investigate the~     effect of elevated plasma lactate levels that are sufficient to impair awareness of~     hypoglycemia on brain lactate concentrations during euglycemia and hypoglycemia in T1DM~     patients with NAH. The objective of part 2 is to compare the effect of exogenous lactate on~     brain lactate concentrations between T1DM patients with NAH and T1DM patients with IAH.~      Furthermore, this study aims to determine the effect of acute hypoglycemia on the~     inflammatory function and composition of peripheral blood mononuclear cells.~   "
21410|NCT03286803|"~     This study will be conducted in four low-income areas of Bin Qasim Town Karachi. This will be~     a community based randomized control trial of 21 months duration. The trial will include four~     arms; arm A and B will enroll children age 14-18 weeks and randomize them to either full dose~     IPV (0.5ml) or fractional IPV (0.1ml). Arms C and D will enroll children at 9 months of age~     and randomize them to either fractional or full dose IPV.~      Children aged 14 weeks for arms A and B and 9 months for arms C and D living in the selected~     communities of Bin qasim Town Karachi who have not received IPV vaccine during routine~     immunization for arms A and B and who have documentary evidence of receiving IPV vaccine at~     14 weeks of age for arms C and D will be eligible for enrollment.~      The investigators will exclude children who are found acutely ill or those requiring emergent~     medical care/hospitalization at the time of enrollment.~      The investigators will use the Demographic Surveillance System (DSS) in the four study areas~     to identify the households with eligible children. The children of the parents who agree to~     participate in the study will be screened for eligibility by the trained research associates.~     After randomization into four different arms, the study trained research vaccinators will~     administer the IPV or fIPV as per randomization. Children will be observed in the center for~     30 minutes after vaccination before leaving for home. Parents/guardians of all the~     participants will also be requested to immediately report any adverse effect occurring later.~      This study will be conducted in compliance with this protocol, GCP guidelines and all~     applicable international and local regulatory requirements. The study has approval by the~     Ethical Review Committee of the Aga Khan University (AKU), the National Bioethics Committee~     of Pakistan, and ethical approval at WHO/Headquarters in Geneva. All study procedures will be~     conducted in AKU's field research sites from where subjects will be recruited. The Clinical~     Trials Unit (CTU) of AKU will be engaged in providing support for specific study procedures~     conducted at CTU such as randomization, management of vaccines (storage, dispensing and~     incineration), and other responsibilities agreed in writing.~      Adverse events following vaccine administration will be monitored and all serius adverse~     events will be reported within 24 hours to WHO, DSMB and AKU IRB. All the vaccines used are~     licensed in Pakistan and in routine use.~   "
21411|NCT03286790|"~     In the present proposal, we hypothesize that specifically targeting pneumonia events with~     preventive interventions in the French EHPAD (Etablissements d'Hébergement pour Personnes~     Agées Dépendantes) setting (thus, improving the health status and quality of life of~     patients) may simultaneously produce relevant reductions in the healthcare costs. In fact,~     although the number of pneumonia cases may be numerically limited, the consequences of each~     event are potentially catastrophic for both the patient and the healthcare system.~     Unfortunately, to date, information about the incidence and economical effects of pneumonia~     in the older population living in the French EHPAD are extremely scare. To adequately~     evaluate whether there is room to implement preventive interventions aimed at reducing the~     onset of pneumonia in a cost-effective fashion on a large scale, preliminary data from this~     specific population are needed. This first step is crucial towards the appropriate design and~     conduction of possible future large-scale intervention trials in the EHPAD setting.~   "
24791|NCT03242512|"~     This is a single-center, open-label, dose-escalating study to evaluate the safety,~     pharmacokinetics, immunogenicity, and preliminary efficacy of single dose subcutaneous~     injection of a fully human monoclonal antibody of receptor activator for nuclear factor-κ B~     ligand (RNAKL) (code name: TK006) in postmenopausal women.~   "
21417|NCT03286712|"~     This is a prospective observational study on incident peritoneal dialysis patients on the~     effect of hemoglobin level and vascular reactivity using the generic erythropoietin alpha.~     The objective of the study is to to describe the effect of improvement in hemoglobin level~     and the flow-mediated dilatation using Epoeitin Alpha (Renogen). Patients who will meet the~     inclusion and exclusion criteria will have their baseline laboratory test and ultrasound of~     the brachial artery to assess the flow mediated dilatation. This is a 3-month follow up study~     with a monthly laboratory test to monitor the patients. The following are the outcome~     measures: hemoglobin level, vascular reactivity by measuring the flow mediated dilatation of~     the brachial artery and blood pressure.~   "
21418|NCT03286699|"~     The goal of the research is to provide a first critical test of the novel scientific idea~     that a combined diet and exercise intervention may ameliorate shortening of leukocyte~     telomere length (LTL) in cancer survivors with a history of non-muscle invasive bladder~     cancer (NMIBC) compared to a diet only intervention.~   "
21419|NCT03286686|"~     To produce hand's movement directed towards a target, the investigator must combine several~     sensory information, such as vision or proprioception. The posterior parietal cortex (PPC) is~     a region of the cortex involved in this multisensory integration. A lesion of the PPC cause a~     visuo-motor trouble called optic ataxia but these patients also have perceptual troubles.~      The aim of the study is to understand the different functions of the PPC and especially how~     the processes of spatial coding of the sensory information influences perception and motor~     planning.~      In this study, the investigator want to explore the sensory motor and the perceptual~     performance of patients with optic ataxia compared with healthy subjects, using 6 behavioral~     tests.~   "
21420|NCT03286673|"~     The study was conducted to investigate the metabolic effects of three different calcium~     compounds in healthy adults.~   "
21421|NCT03286660|"~     Improvement in the functional functioning and dyspnea of COPD patients after a rehabilitation~     program (RHB) is assessed by exercise tests and questionnaires difficult to replicate outside~     specialized centers.~      In order to monitor the eventual decline of patients in the course of their RHB management,~     Chair Rise Tests (3CRT-1CRT-5STS) and short questionnaires were developed (CAT-DIRECT). The~     goal of this prospective, multicenter, real-life study is to compare the change in several~     functional function tests and questionnaires of quality of life and dyspnea related to daily~     activities. In addition, MCIDs of the 3CRT and the DIRECT questionnaire (Disability Related~     to COPS Tool) were specified.~   "
21422|NCT03286647|"~     to investigate the effect of oral hygiene self-efficacy in patients with grief (G) and~     complicated grief (CG)~   "
21423|NCT03286634|"~     To evaluate the outcome of a prednisolone and low dose methotrexate based protocol in Down~     syndrome children with ALL (DS-ALL) in an Asia-wide study. The treatment protocol was~     modified based upon backbone of Taiwan Pediatric Oncology Group (TPOG)-ALL protocol in which~     risk classification will be guided by level of flow minimal residual disease (MRD) instead.~   "
21424|NCT03286621|"~     The main aim of the present study is to examine eye-tracking based markers for social~     processing deficits in children with autism spectrum disorder (ASD). To this end a battery of~     five eye-tracking paradigms will be administered to young children with ASD and typically~     developing children. To additionally evaluate the specificity of the eye-tracking markers a~     group of children with disorders of delayed development other than ASD will be included.~   "
21425|NCT03286608|"~     This project aims to leverage existing data from a large observational prospective study on~     dementia, the Three-City study, to investigate the relationship between intakes of~     polyphenols and the risk to develop dementia in the 12 years following dietary assessment.~   "
21426|NCT03286595|"~     The project aims to test the utility of implementing a mobile health application (mhealth~     app) in early psychosis care in the community outpatient setting and in the university~     medical center setting. We will enroll 60 individuals in the early stages of psychotic~     illness who are receiving care in two UC Davis affiliated community based early psychosis~     outpatient programs: the Aldea Child and Family Services SOAR Programs in Napa and Solano~     Counties (Napa SOAR, and Solano SOAR), as well as the UC Davis Early Psychosis Programs~     (EDAPT and SacEDAPT clinics). Early psychosis (EP) participants will include individuals at~     high risk for developing a psychotic illness (termed clinical high risk or CHR) and~     individuals within two years of their first psychotic episode (termed first episode~     psychosis or FEP). Over the course of five months, EP participants will use the app on their~     mobile device to complete daily surveys assessing mood, social interactions and medication~     adherence, and weekly surveys assessing clinical symptoms, sleep and medication adherence. EP~     participants will also complete clinical assessments with UC Davis research staff at the~     initial and final study appointments (baseline and five month timepoints). Clinicians working~     in the three early psychosis programs will also participate in the study. In their clinical~     role, they will interact with EP participants' app data via the Dashboard, a secure web-based~     portal, and provide feedback on the clinical utility of the data that is provided on the~     dashboard. EP participants and their clinicians will also provide feedback on the impact of~     the app on the therapeutic relationship.~   "
21427|NCT03286582|"~     Bullous pemphigoid (BP) is a chronic, inflammatory, subepidermal, autoimmune blistering~     disease which mainly develops in the elderly, with onset usually in the late 70s and a~     substantial increase in incidence in people older than 80 years. If untreated, it can persist~     for months or years, with periods of spontaneous remissions and exacerbations. It has been~     found that blisters and sera of BP patients contain abnormally high levels of~     pro-inflammatory cytokines such as interleukin-6 (IL-6) and IL-8. Recently, it also has been~     demonstrated that NLRP3 (NACHT, LRR and PYD domains-containing protein 3) inflammasome~     components (the NLRP3-caspase-1-IL-18 axis) were significantly up-regulated in peripheral~     blood mononuclear cells from BP patients and positively correlated with disease activity.~     AC-203 is a topical formulation of an oral modulator of inflammasome and IL-1beta pathways.~     In vitro studies have demonstrated that AC-203 significantly reduced secretion of IL-6 and~     moderately reduced IL-8 secretion in HaCaT cells treated with specific anti-BP180 IgG. This~     study is designed to test the safety, tolerability, efficacy, and pharmacokinetics of AC-203~     ointment (vs. a topical steroid comparator representing standard of care) ointment in~     subjects with BP.~   "
21428|NCT03286569|"~     Young children with backward positioned lower jaw/chin will be recruited to have an upper jaw~     expansion appliance. Previous research showed that the use of similar appliances can lead to~     lower jaw forward growth. 60 young children aged 9-11 will be recruited to have either active~     or non-active Wilson type upper arch expansion appliance. Patients will have special x-ray~     (Cone Beam computed tomography) before and after treatment (after 9 months) of starting the~     treatment. After participation, routine orthodontic treatment will be continued.~   "
21429|NCT03286556|"~     Acute exacerbations (AE) are a dreaded manifestation of idiopathic pulmonary fibrosis (IPF)~     that presents with rapidly worsening respiratory function over days to weeks. AE account for~     about 1/2 the deaths in IPF patients, and are refractory to all medical therapies attempted~     to date.~      Considerable preliminary data shows pathological B-cell abnormalities and autoantibodies are~     present in AE-IPF and associated with disease severity.~      The experimental therapy here (therapeutic plasma exchange plus rituximab plus intravenous~     immunoglobulin) is mechanistically targeted to ameliorate autoantibody-mediated pulmonary~     injury. Anecdotal pilot studies indicate these treatments have significant benefit for a~     disease syndrome that has, until now, been almost invariably inexorable. This clinical trial~     has the potential to profoundly affect current paradigms and treatment approaches to patients~     with AE-IPF.~   "
21430|NCT03286543|"~     The purpose of this study is to determine if electrical stimulation (small levels of~     electricity) in addition to the standard of care can safely and effectively reduce pain~     following total knee replacement more than the standard of care, alone. This study involves a~     device called the SPRINT Beta System. The SPRINT Beta System delivers mild electrical~     stimulation to nerves in the leg that received the knee replacement. The SPRINT Beta System~     includes a small wire (called a lead) that is placed through the skin in the upper leg. It~     also includes a device worn on the body that delivers stimulation (called the SPRINT Beta~     Stimulator). About half the subjects in this study will receive the SPRINT Beta system~     (treatment group) and half will not (control group). Both groups will receive the standard of~     care.~   "
21431|NCT03286530|"~     This research study is studying a drug that may help decrease the chances of relapse after~     Allogeneic Stem Cell transplantation for Acute Myeloid Leukemia. The name of the study drug~     involved in this study is:~      • Ruxolitinib~   "
21432|NCT03286517|"~     The specific objective of this study was to investigate the sensitivity of Kisspeptin~     receptor 1 (KISS1R) by determining the responsiveness of GnRH neuron to kisspeptin~     administration across the pubertal stages and adult group through measuring plasma LH~     (luteinizing hormone) and testosterone concentrations.~   "
21433|NCT03286504|"~     The investigators will conduct a randomized controlled trial of Group Care in the GHESKIO~     Community Center versus Individual Care in the GHESKIO Adolescent Clinic for 160 HIV-infected~     adolescent girls age 16-19 years in Haiti (80 adolescents per arm). Group Care includes~     receiving integrated clinical and social support services in groups of 5-8 adolescents at a~     monthly visit. The primary outcome is retention in HIV care at 12 months after randomization.~   "
21434|NCT03286491|"~     Acute coronary syndromes are among main complains for patients presenting to emergency~     department. Risk classification systems are used to classify patients to appropriate risks~     and help physicians manage diagnosis strategies and treatments. Purpose of this study is to~     develop a clinical decision support system for patients presenting to emergency department~     with the help of statistical machine learning.~   "
21435|NCT03286478|"~     Body image is one of the leading concerns for young people. Such concerns can have serious~     health consequences, including unhealthy weight control and exercise behaviours, depression,~     smoking, low self-esteem and misusing drugs and alcohol. Leading and emerging approaches for~     improving body image are effective among older adolescent females, and when delivered by~     expert providers (e.g., psychologists). However, there is a need for body image programmes~     that include males and so can be delivered in co-educational settings, and can be delivered~     by non-expert providers (e.g., teachers within schools) to facilitate cost-effective and~     ongoing use.~      This project will evaluate three classroom-based programmes for improving young people's body~     image, delivered by class teachers to girls and boys aged 13-14 years in secondary schools.~     Two programmes are based on leading (cognitive dissonance) and emerging (mindfulness)~     approaches for improving body image, but which have not been previously evaluated with both~     boys and girls and when delivered by teachers. The third programme has previously~     demonstrated effectiveness in improving body image when delivered by teachers to boys and~     girls in the classroom setting, and therefore will provide a useful comparison to benchmark~     these programmes.~      To assess the impact of each programme, the current study will compare the body image and~     well-being of students who take part in each programme to students who take part in an~     alternative programme, and those who do not take part in any programme (classes as usual),~     over a 6-month period. The investigators will also assess the extent to which gender and~     pre-existing levels of body image concerns impacts the benefit received from taking part in~     the lessons. To undertake this project, the investigators will recruit students and teachers~     from 24 schools in Bristol and surrounding areas in the South West of England. Students will~     complete questionnaire assessments of body image and well-being before and after the 5-week~     programme period, and again 6 months later to assess longer-term benefits. The investigators~     will also gain in-depth feedback from students and teachers via focus groups and interviews,~     in order to inform future improvement of the programmes for wider implementation.~      Therefore, this trial will assess whether the two newly adapted programmes result in improved~     body image compared to those who receive their classes as usual, and compared to an existing~     teacher-led programme.~   "
21436|NCT03286465|"~     This study will evaluate the hypothesis that the use of pediatric size phlebotomy tubes~     reduces RBC transfusions in adult ICU patients compared with the use of adult size tubes.~   "
21437|NCT03286452|"~     The RESPOND Registry is an observational study to assess the impact of PuraPly™ AM on the~     management of wounds in real world clinical settings; no experimental intervention is~     involved.~   "
21438|NCT03286439|"~     This study aims to investigate the in-hospital care as well as the cognitive status, quality~     of life, physical function and risk of anxiety and depression, sleep disorders and drug use~     in a Danish cohort of both medical and surgical patients with acute critical illness without~     admittance to ICU (Intensive Care Unit) treatment, at three and twelve months after hospital~     discharge.~   "
21439|NCT03286426|"~     The purpose of this study is to evaluate the vision and posterior segment of eyes in children~     and young adults less than 22 years of age with risk, suspicion, or past medical history~     significant for elevated intracranial pressure (ICP). Patients will have visual acuity and~     color vision tested. Assessment of the posterior segment will involve using a non-invasive~     (non-contact) imaging technique (i.e. a portable fundus camera in clinic and hospital~     settings).~   "
21440|NCT03286413|"~     The investigators will perform this study to prospectively compare the clinical outcome after~     percutaneous microwave ablation(MWA) and cryoablation of benign and malignant breast lesion~     under ultrasound (US) guidance.~   "
21441|NCT03286400|"~     Collect real-world clinical and device-specific outcomes of the GORE® TAG® Conformable~     Thoracic Stent Graft featuring ACTIVE CONTROL System (CTAG Device with ACTIVE CONTROL) in the~     treatment of aortic disease as part of routine clinical practice.~   "
21442|NCT03286387|"~     The project is dedicated to development of new paradigms to investigate memory and attention~     in the rich and realistic environments. The investigator will use modern interactive digital~     technologies for encoding complex episodes either using mobile phone technology in everyday~     life or using a virtual reality life-like simulation.~      He aims to characterize the role of the medial temporal lobe and prefrontal cortex during~     recall of naturalistic episodic experiences, using functional neuroimaging (fMRI) in healthy~     participants. The secondary aim is assess how the allocation of attention during memory~     encoding contribute to mechanisms of the subsequent recall. He will achieve this by~     monitoring gaze direction during encoding and by analyzing the retrieval data as a function~     of the elements that participants attended / fixated during encoding.~      The protocol will involve, first, behavioral testing of memory performance with encoding in~     the real-life or in virtual reality, followed by the main hypothesis testing phase when fMRI~     will be used to measure brain activity during retrieval.~   "
21443|NCT03286374|"~     The main aim of this Cohort trial is to get more information about how life style changes~     affect work participation for people with BMI above 30. The information can contribute to~     improving the quality of occupational rehabilitation programs in the specialized health care~     services and for others who work with weight loss programs and work related rehabilitation~     programs.~   "
21444|NCT03286361|"~     The BeGraft Plus PMCF Trial investigates the efficacy of the BeGraft Peripheral Plus Stent~     Graft System in the treatment of iliac stenotic or occlusive lesions (TASC A, B, C and D). An~     expected total of 20 patients with TASC A and B lesions and an expected total of 50 patients~     with TASC C and D lesions will be treated. The lesion is located within the native Iliac~     arteries. Prior to stenting with the BeGraft Peripheral Plus Stent Graft System,~     pre-dilatation can be performed according to the physician's discretion. Also post-dilatation~     can be performed according to the physician's discretion. Patients will be invited for a~     follow-up visit at 1, 6 and 12 month post-procedure. The primary efficacy endpoint of the~     study is the primary patency at 12 months. The primary safety endpoint is the freedom of~     periprocedural Serious Adverse Events (SAEs). Secondary endpoint include primary patency rate~     at 1 and 6 month, stent graft occlusion rate at pre-discharge, 1, 6 and 12 month follow-up,~     anke-brachial index (ABI) at 1, 6 and 12-month follow-up, amputation rate at 1, 6 and~     12-month follow-up, performance success rate, freedom from target lesion revascularization~     (TLR), technical success and clinical success at 1, 6 and 12-month follow-up.~   "
21445|NCT03286348|"~     To assess the effectiveness of close and intense monitoring on nutritional status of~     gastrointestinal cancer patients during chemoradiotherapy (CRT), 500 CRT patients diagnosed~     with gastrointestinal system are going to be recruited into this prospective study.~     Patient-generated subjective global assessment (PG-SGA) scale and nutrition risk screening~     (NRS-2002) are used for nutritional assessment at the beginning and the end of CRT; Beside~     the nutritional parameters, Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and gastric~     cancer module (QLQ-STO22) are used to measure quality of life in patients with gastric cancer~     while EORTC QLQ-C30 and Colorectal Cancer-Specific Quality of Life Questionnaire (QLQ-CR38)~     give assessment in colorectal cancer. The acute and late radiation toxicities were evaluated~     based on Conmon terminology criteria (CTC V3.0) and the toxicity criteria of RTOG/EORTC,~     respectively. Follow-ups every 3-6 months until three years after chemoradiotherapy are~     involved. Response Evaluation Criteria in Solid Tumors (RECIST) guidelines are used for~     response assessment. The primary endpoints are 3-year local control, disease-free survival,~     distant metastasis and overall survival rate.~   "
21446|NCT03286335|"~     This research study is studying Proton Radiation as a possible treatment for brain tumor.~      The radiation involved in this study is:~      -Proton Radiation~   "
21447|NCT03286322|"~     In more than 90% of cases, victims of fall are elderly people over 65. Nearly the third of~     those people fall at least 1 time by year. The incidence substantially increases for people~     over 80 and women are at higher risk than men.~      The value of balance rehabilitation no longer needs to be demonstrated in Gerontology.~     Nevertheless, a more specific therapy based on the aged-related cervical problems seems to be~     essential. Indeed, those problems are numerous (arthrosis-like pains, joint stiffness,~     muscular contractures…) and often lessen vestibular and/or proprioceptive afferents. The~     cervical spine is a link between different systems which regulate balance, as the visual,~     vestibular and cervical systems (muscular, articular afferents…), and this role is key to~     balance control. Indeed, the cervical spine owns an exceptional function thanks to Ruffinian~     corpuscles, muscle and neurotendinal spindles.~      Many studies point up the importance of the relation between balance, cervical spine and~     vestibular system, and others between tissue changes and postural adaptations in elderly~     people. Nevertheless, the take into consideration of all these data and their impacts in~     rehabilitation has not been reported yet.~      This brings us to question the added-value of a cervical mobility management in balance~     rehabilitation in Gerontology.~   "
21448|NCT03286309|"~     The soft robotic system could provide objective and quantifiable measures of subject~     performance. By combining voluntary motor intention and the robotic hand technology, the~     system will facilitate the recovery process of stroke patients.~   "
21449|NCT03286296|"~     To assess the safety and tolerability of IV administered LZM009 in subjects with advanced~     solid tumors who have progressed or are non-responsive to available therapies.~   "
21450|NCT03286283|"~     This study evaluates the safety and effectiveness of J-Plasma in the reduction of facial~     wrinkles and rhytides. It is a multi-center, single arm, evaluator-blind prospective study of~     55 study subjects who are seeking a procedure to reduce the appearance of wrinkles and~     rhytides and will be conducted at up to 5 investigational centers in the United States. Each~     study subject will receive one procedure with J-Plasma at enrollment. Follow-up will occur~     immediately following the procedure, at 10 days, 1, 3, and 6 months after enrollment.~   "
21562|NCT03284801|"~     Acute disseminated encephalomyelitis is an immune-mediated inflammatory demyelinating disease~     of the central nervous system, which is typically transitory and self-limiting. It is~     characterized by an acute or subacute encephalopathy with neurological deficits, and magnetic~     resonance imaging evidence of widespread demyelination that predominantly involves the white~     matter of the brain and spinal cord. In the absence of specific biological markers, the~     diagnosis of Acute disseminated encephalomyelitis is still based upon a combination of~     clinical and neuro imaging features and exclusion of diseases that mimic Acute disseminated~     encephalomyelitis~   "
21451|NCT03286270|"~     Early intervention attempts to shorten protracted delayed union (DU) or prevent non-union~     (NU) fractures are hampered by lack of validated quantitative assessment tools for bone~     fracture healing during normal and delayed healing processes. In actual practice, sequential~     X-rays usually follow a pre-determined time interval in patients with fractures.They~     constitute the best available state of the art used by surgeons to assess the fracture~     healing course.~      In an attempt to improve between raters reliability of radiographic assessment of healing,~     studies have explored a novel radiographic assessment for tibial shaft fractures, the~     Radiographic Union Scale for Tibial Fractures (RUST). The RUST assesses the presence of~     bridging callus and a fracture line on each of four cortices (seen on anterior-posterior and~     lateral views). This callus based scoring system has been since extended to other bones than~     the tibia in a retrospective case series. It has been renamed modified radiological union~     score (mRUS) and has shown potential value in bone healing measurement.~      Based on an initial retrospective study in nail-treated fractures, the first objective of the~     present investigation is to prospectively validate mRUS as a tool to identify patients at~     increased risk of DU and NU within the first 75-110 days after fracture occurrence. This~     prospective validation will be performed on a retrospective cohort of patients having~     sustained long bone fractures, including both upper and lower extremities. A further~     objective of the present investigation is to apply the scoring system to tomographic imaging~     in case of nail/plate treated fractures, deriving a tomographic union score (TUS) and first~     assess its potential value in bone healing for fractures treated by nails/plates.~   "
21452|NCT03286257|"~     In brief, this study sets out to understand if exercise training can reduce the frequency and~     severity of hot flushes associated with breast cancer treatment.~   "
21453|NCT03286244|"~     This is an open-label, Phase 1b study which will be conducted in two parts: part A is the~     dose escalation study while part B is dose expansion study. The purpose of the dose~     escalation part is to identify the maximum tolerated dose (MTD) and/or recommended phase II~     dose (RP2D) of CM082 combined with paclitaxel in patients with advanced gastric cancer who~     did not respond to first-line standard chemotherapy. In the subsequent dose expansion part,~     additional subjects will be enrolled to further explore the safety and preliminary clinical~     activity of CM082 and paclitaxel.~   "
21454|NCT03286231|"~     The purpose of this study is to evaluate the effect of the gluteal vasculature in the prone~     and jackknife positions.~   "
21455|NCT03286218|"~     The purpose of this study is to assess the abuse potential of study drug lasmiditan.~      Lasmiditan will be compared to a marketed benzodiazepine, alprazolam (positive control), as~     well as to placebo (dummy substance that looks like lasmiditan or alprazolam without any~     active drug) to determine the potential for drug abuse. The dosages will be in tablet form~     and will be taken orally (by mouth).~      This study will last about 55 days, including screening. Screening will occur within 28 days~     prior to qualification phase.~   "
21456|NCT03286205|"~     The purpose of this study is to establish which dosing schedule of INfed (Iron dextrose) is~     superior for the treatment of iron deficient anemia.~   "
21457|NCT03286192|"~     The purpose of this study is to evaluate the feasibility of implementing a Compassion~     Cultivation Training (CCT) program for oncology nurses at Sylvester Comprehensive Cancer~     Center. The goal of CCT is to provide a structured and systematic way of cultivating~     daily-life skills needed to strengthen qualities of compassion, empathy, and kindness for~     oneself and others. CCT typically includes (i) eight weekly 2-hour classes and (ii) daily~     practice. The in-class activities include pedagogical instruction and active group~     discussion, guided meditation, interactive practical exercises, and sharing of inspiring~     readings/stories to prime feelings of open-heartedness or connection to others.~   "
21458|NCT03286179|"~     Chest pain is the second leading reason for emergency department (ED) visits in the United~     States. Resource utilization for this ED subpopulation is particularly high, in part due to a~     dearth of accepted standardized clinical approaches and general overestimation of risk on the~     part of both providers and patients. This prospective observational cohort study seeks to~     address this issue by providing externally validated risk scores for major adverse cardiac~     events using a web-based clinical decision support platform (RISTRA) embedded within the~     electronic health record at 13 Kaiser Permanente Northern California (KPNC) EDs over a~     12-month period. The decision support will provide risk estimates specific to the KPNC~     patient population. This studies hypothesis is that the provision of more accurate risk~     estimation for major adverse cardiac events will improve informed decision making by both~     providers and patients, resulting in less provocative testing and lower ED lengths of stay~     amongst low risk patients, as well as improving medical management among non-low risk~     patients and decreasing future rates of major adverse cardiac events.~   "
21459|NCT03286166|"~     A randomized controlled trial to evaluate the efficiency of serum tears made with Genius PRP~     for improving signs and symptoms in Dry Eye Disease (DED).~      Single center, Prospective, Randomized, Controlled, Non-significant risk~   "
21460|NCT03286153|"~     This is a randomized, prospective, multicenter study to examine whether or not the current~     recommended factor dosing strategy - i.e., dosing by actual body weight - in overweight and~     obese patients with Hemophilia A may deliver excessive clotting factor to achieve the desired~     result of bleeding prevention and cessation. This study also examines ways to prevent~     delivering excessive factor by using a patient's ideal body weight as a new dosing strategy~     compared to the current dosing strategy. The hypothesis being tested is that factor dosing~     based on ideal body weight will result in protective factor levels.~   "
21461|NCT03286140|"~     The EVRA study evaluates the effects of early endovenous ablation on ulcer healing in~     patients with chronic venous ulceration. Half the patients are randomised to receive early~     endovenous ablation (within 2 weeks) and half to standard care~   "
21488|NCT03285789|"~     dyslexia is often considered like a phonological deficit but some researches show that a~     visual attention (V-A) deficit can occur in dyslexia. The investigator want to show that some~     dyslexics have a reduced V-A field in visual search when the investigator use separable~     feature (letter-like).~      If the investigator demonstrate that, he will show that V-A deficit can be transpose to an~     ability acquired before reading, the visual search. Therefore, the V-A deficit can't be a~     consequence of reading problem but a cause of it for some dyslexics.~      The investigator could imagine an earlier diagnosis for children at risk to develop dyslexia~     and make reeducation more specific for the deficit observed.~   "
21462|NCT03286127|"~     For patients with an advanced disease and their families an excellent and compassionate care~     is essential. However, in hospitals optimal end-of-life care is not yet fully realized and~     patient's needs are often not met. Palliative care is able to increase patients' quality of~     life and to carefully meet their and their families' needs.~      To improve the awareness of unmet needs patient-reported outcome measurement has been the~     pivot of latest palliative care research. Besides the improvement of care outcome measurement~     allows the evaluation of the quality of palliative care and comparisons on a national and~     international level.~      The aim of the present study is to evaluate the quality of palliative care in different~     settings (palliative care unit, inpatient and outpatient consultation teams) using the~     Integrated Palliative Care Outcome Scale (IPOS). The IPOS has been lately developed as~     improved follow-up version of the Palliative Care Outcome Scale (POS) integrating most~     important questions and simultaneously being brief and comprehensive. The study is planned as~     a multi-centric observational study. Primary endpoint is the reduction of symptom burden of~     patients.~      The clinical study hypothesis bases on the assumption that palliative care can change the~     symptom burden, measured by a change in the IPOS overall profile score, and that there might~     be a difference in the size of the effect depending on the caring setting.~   "
21463|NCT03286114|"~     This is a single arm, open-label, Phase 1b study of pembrolizumab for patients with~     myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), and acute lymphoblastic~     leukemia (ALL) whose disease has relapsed after receiving allogeneic hematopoetic stem cell~     transplant.~   "
21464|NCT03286101|"~     This is a randomized, double-blind, placebo-controlled clinical study evaluating the efficacy~     and safety of a single application of 0.5% ivermectin lotion in Filipino subjects with head~     lice.~   "
21465|NCT03286088|"~     The study primarily aims to collect standard of care clinical data in a wide spectrum of~     simple to complex mitral valve regurgitation (MVR) cases to validate a post-processing~     stand-alone software prototype (QFlow), developed by Philips Research Paris (Medisys).~      Investigator does not intervene in the care of the patient, but simply collects standard of~     care images and measurements that are needed for the validation of the investigational~     software.~   "
21466|NCT03286075|"~     The dorsolateral prefrontal cortex (DLPFC) plays a key part in emotional processing and~     regulation.~      Emotions continually influence other cognitive functions such as attentional resources~     .Emotions also influence a subject's automatic physiological responses .~      Transcranial direct current stimulation (tDCS) is an innovative neuro-modulation treatment,~     often used in major depression.~      Various studies have shown that it is possible to modulate emotional processing in healthy~     subjects, however the impact of this modulation on attentional resources and physiological~     responses has not been studied. Also, the mechanisms of action of the tDCS on emotional~     processing are still unclear.~      It is necessary to explore the modulation of the DLPFC in healthy subjects in order to better~     understand the network and mechanisms at stake in the processes.~      Thus, investigators plan to study the modulation of the DLPFC (left and right) by tDCS~     (anode, cathode and placebo) on the processing of emotions and the impact on attentional~     resources, and physiological responses.~   "
21467|NCT03286062|"~     A laproscopic imaging tecgnology that uses a synthetic agent to detect ovarian and pancreatic~     cancers at an early stage so that patients can get treatment early and prevent the disease~     from advancing to late stage leading to fatality or recurrence.~   "
21468|NCT03286049|"~     Longitudinal, observational study to assess the short-term (test re-test) and mid-term~     (within the span of 28 days) repeatability of active anterior rhinomanometry (AAR) measures~     on 4 parallel groups of children with different rhinitis phenotypes, and 1 group of control~     (healthy) children.~      Secondary objectives are: i) assessing of association between AAR, exhaled FeNO (eFeNO) and~     nasal FeNO (nFeNO); ii) assessing association between objective measurements (AAR, eFeNO and~     nFeNO) and subjective measurements (Total 5 Symptom score, T5SS).~      The study is intended to obtain useful information for improving rhinitis management.~   "
21469|NCT03286036|"~     The classification of lung cancer (LC) according to the degree of anatomical extension (TNM)~     allows the estimation of the prognosis of the patient, although its accuracy is limited. In~     fact, one third of surgically-treated patients with initial disease have recurrences during~     follow-up, despite the negativity of node dissection at surgery. The incorporation of~     genetic, epigenetic and proteomic information to TNM staging will characterize more~     accurately the lung cancer, and thereby improve the prognostic and the prediction of the~     therapeutic response in these patients.In this project a prospective cohort of 320 patients~     with lung cancer staged I-IIp will be studied, combining the clinical and pathologic~     information available with genetic, epigenetic and proteomic markers in tumour samples,~     pulmonary tissue, regional nodes and peripheral blood, preserved in suitable systems for the~     application of complex analytical methodologies. Thus, a knowledge database will be created~     with the aim of improving the prognostic and prediction capabilities of TNM staging.This~     project is coordinated with related sub-projects that cover the required laboratory tests on~     biological samples and with Spanish collaborative group in lung cancer.~   "
21470|NCT03286023|"~     Stereotactic radiotherapy is an innovative treatment enabling to target accurately brain~     metastases. The aim of this study is to evaluate tumoral response and acute and late toxicity~     of this treatment.~   "
21498|NCT03285646|"~     The primary objective of the study is to evaluate the efficacy of fasinumab in relieving~     Chronic low back pain (CLBP) as compared to placebo in patients with a clinical diagnosis of~     moderate-to-severe non-radicular CLBP and Osteoarthritis (OA) of the knee or hip when treated~     for up to 16 weeks. The secondary objectives of the study are: To evaluate the safety and~     tolerability of fasinumab compared to placebo when patients with a clinical diagnosis of~     moderate-to-severe non-radicular CLBP and OA of the knee or hip are treated for up to 16~     weeks; To characterize the concentrations of fasinumab in serum over time when patients with~     a clinical diagnosis of moderate-to-severe non-radicular CLBP and OA of the knee or hip are~     treated for up to 16 weeks; To evaluate the immunogenicity of fasinumab when treated for up~     to 16 weeks in patients with a clinical diagnosis of moderate-to-severe non-radicular CLBP~     and OA of the knee or hip.~   "
21563|NCT03284788|"~     The purpose of this study is to investigate the effects of an acceptance-based therapy~     intervention on adolescents, to receive feedback about the program, and to learn about~     potential changes we could make to improve the program.~   "
21471|NCT03286010|"~     Women with heart disease are more likely to die or suffer another cardiac event or stroke~     within 5 years of an index event compared to men. They are also more likely to suffer~     depression and report lower quality of life. Cardiac Rehabilitation programs have been~     designed to address these issues, but most women do not attend. Women indicate they have a~     greater need to talk about their experiences with heart disease and seek social support to~     help them cope. Peer support, the assistance provided by other women with a similar illness~     experience, may be one way to enhance social support for women with heart disease and help~     them improve their psychosocial well-being. The Investigators have developed a peer support~     program called Women@Heart (W@H). The program is led by trained peer leaders (women who~     themselves have made a successful recovery from a heart event). A pilot test of the program~     showed promising results. The Investigators now need to conduct a more rigorous evaluation of~     the program.~      The main objective of this project is to determine if the W@H program helps women to improve~     their psychosocial well-being compared to being on a waiting list to participate in the~     program. It will also examine the effect of the program on: health behaviours (tobacco~     smoking, physical activity, sedentary behaviour, fruit and vegetable consumption, and~     medication adherence); coronary risk factors; arterial health; and clinical outcomes~     (re-hospitalization, health care system use, death).~   "
21472|NCT03285997|"~     If study subject's legal guardians who decide voluntarily to participate the clinical trial,~     and sign the Informed Consent Formed, study subjects eligible for participating this trial~     protocol were assigned to test group or control group with the ratio of 4:1 and receiving the~     test or control drug 1 time or 2 times.~   "
21473|NCT03285984|"~     The aim of this study is to evaluate and compare the plaque removal efficacy of four~     experimental toothpastes following a single timed brushing. Prior to each treatment visit,~     participants will abstain from oral hygiene for a period of 24 hours (+6hrs, -2hrs),~     immediately preceding a pre-brushing dental plaque evaluation. Participants will then brush~     once under supervision for one timed minute with each dentifrice after which re-disclosing~     and a post-brushing plaque assessment will be carried out.~   "
21474|NCT03285971|"~     Across broad surgical populations, cerebral hypoperfusion is associated with increased~     mortality, stroke, brain cellular injury, and poor functional outcomes. Based on available~     evidence, The Brain Trauma Foundation recommends that cerebral perfusion pressure (CPP) be~     maintained greater than 60 mmHg in high-risk settings to minimize risk of cerebral ischemia.~     Though several lines of investigation have focused on optimal cerebrovascular management in~     the intensive care unit and cardiac surgery settings, much less focus has been placed on~     cerebrovascular management during non-cardiac surgery.~      Preliminary data indicate that intraoperative CPP routinely falls below 60 mmHg in~     neurosurgical and trauma surgery settings, though the relationship between reduced~     intraoperative CPP and outcomes remains unclear. Furthermore, effective methods by which low~     intraoperative CPP could be prevented have not been thoroughly investigated, which represents~     the first required step prior to studying the relationship between intraoperative CPP and~     clinical outcomes. Thus, the aim of this study is to evaluate the efficacy of an automated~     algorithm that alerts clinicians to a decrease in CPP below 60 mmHg. This study tests the~     hypothesis that an automated pager alert system (triggered by CPP falling below 60 mmHg) will~     increase intraoperative CPP compared to standard of care.~   "
21475|NCT03285958|"~     Wearable, commercially-available physical activity monitors are being increasingly~     incorporated into chronic pain self-management interventions as a tool to help patients set~     goals and to tailor intervention content based on patient progress. Yet older adults from~     resource-challenged communities may face significant barriers to using these monitors and~     reporting activity data. Our pilot study will focus on wearable monitor use among older~     adults in Detroit with chronic musculoskeletal pain, testing the feasibility and validity of~     various technology-based strategies for reporting daily step count data. The study will also~     assess whether six weeks of monitor use is associated with improvements in functioning,~     relative to a control group.~   "
21476|NCT03285945|"~     Giant cell arteritis (GCA) affects large and medium sized vessels. Large vessel-GCA (LV-GCA)~     affecting aorta and/or its main branches is seen a) together with temporal arteritis~     (AT-GCA), b) as isolated LV-GCA but also c) with polymyalgia rheumatica.~      There is a risk of vision loss and cerebral thromboembolic events or great vessel injury in~     GCA. With delayed or inadequate treatment mortality and morbidity increases. This highlights~     the need of fast diagnosis and early treatment.~      The cornerstone in the diagnosis of GCA is a positive temporal artery biopsy. Patients with~     LV-GCA have more general, but less cephalic symptoms than patients with AT-GCA. Also, biopsy~     from large vessels can rarely be done and only 50% have a positive temporal artery biopsy~     (TAB). Hence, diagnosis often rely on imaging.~      Fluorine-18-fluorodeoxyglucose positron-emission tomography (FDG PET)/CT has shown high~     diagnostic sensitivity and specificity and is believed to be superior to other imaging~     modalities in the diagnosis of LV-GCA . The impact of FDG PET/CT in the management of LV-GCA~     has been evaluated and has shown to increase the diagnostic accuracy in a significant~     proportion of patients. However, studies have indicated a lower sensitivity in steroid~     treated patients.~      The aim of this study, was to evaluate the effect of steroid treatment on large-vessel FDG~     uptake in new-onset, treatment-naive LV-GCA by repetitive FDG PET/CT pre- and post~     therapeutic. With insights into the diagnostic capabilities after treatment is initiated, the~     possibility of timely treatment and confident diagnostic work up will improve.~   "
21499|NCT03285633|"~     This study examines the feasibility and acceptability of an open trial of mindfulness-based~     Cognitive Behavioral Therapy intervention delivered via telephone to men and women age 21 and~     older with a diagnosis of advanced cancer. Potential participants (N=35) will be recruited~     via letter from their oncologist at community-based clinics (N=18) and those served at the~     Duke Cancer Institute in Durham who live more than 60 miles away (N=17). Following informed~     consent, participants will be asked to complete assessments (e..g., examining their pain,~     anxiety, depression, fatigue, and engagement in valued activity). They will then receive 4~     weekly 50-minute telephone sessions with a study therapist and practice skills learned in~     session at home. After completing the 4 sessions, they will complete a post-treatment~     assessment. Data analyses will examine the feasibility and acceptability of the study by~     assessing participant engagement, and will examine changes in key psychological variables~     (e.g., pain, anxiety, depression, fatigue, and valued activity) from baseline to~     post-treatment.~   "
21477|NCT03285932|"~     In advanced cancer disease brain metastases are common, difficult to treat, and are~     associated with a poor prognosis. As new local and systemic therapies are eventually~     resulting in improved survival and quality of life for patients with brain metastases,~     negative neurocognitive effects of radiation therapy are becoming increasingly important as~     well as good loco-regional disease control of brain metastases.~      Concerning treatment, brain metastases remain a major clinical problem and a~     multidisciplinary approach to management should be adopted. Neurosurgical resection with~     postoperative whole brain radiotherapy (WBRT) is one major treatment option in solitary or~     symptomatic brain metastases. Furthermore, WBRT is recommended for multiple brain metastases.~     For a limited number of brain metastases stereotactic radiosurgery (SRS) has been established~     as a highly effective treatment alternative.~      Recently, a new treatment approach combing neurosurgery with postoperative stereotactic~     radiotherapy (SRT) of the resection cavity is emerging. Based on available evidence,~     postoperative SRT of the resection cavity improves local control following surgery, reduces~     the number of patients who require whole brain radiotherapy, and is well tolerated (1).~      This protocol is aimed at primarily evaluating the safety and toxicity profile of SRT to the~     resection cavity following neurosurgical resection combined with SRT of potentially further~     unresected brain metastases, compared to postoperative whole-brain radiotherapy (WBRT).~     Secondary, the local effect of SRT in patients with brain metastases will be assessed by~     measuring time to local recurrence (LR), local and loco-regional progression-free survival~     (PFS).~      Additional systemic treatment will be carried out according to the standards of the National~     Center for Tumor Therapy (NCT).~   "
21478|NCT03285919|"~     A control and a post-stroke subject with right-side chronic hemiparesis were studied. The~     post-stroke subject underwent 30 sessions of balance-perturbed training while walking on an~     instrumented treadmill where the Balance Assessment Robot (BAR™) randomly delivered pushes to~     pelvis in various directions at various speeds and at various perturbation amplitudes. The~     investigators assessed kinematics, kinetics, electromiography and spatio-temporal responses~     to outward-directed perturbations commencing either at foot contact of the left or the right~     leg.~   "
21479|NCT03285906|"~     The purpose of this Phase II, Open-label, single arm, exploratory study is to evaluate the~     efficacy and the safety of Apatinib（500mg/d）for the second - line treatment of esophageal~     cancer or esophageal and gastric~   "
21480|NCT03285893|"~     DNA adducts in the oral mucosa cells of 100 smokers from 3 ethnic groups - Native Hawaiians,~     Whites, and Japanese Americans with differing risks for lung cancer upon cigarette smoking~     will be quantified. DNA adducts of tobacco smoke carcinogens will be quantified using both~     targeted and untargeted approaches.~   "
21481|NCT03285880|"~     The specific objective of the proposed research is to examine whether naps contribute to~     immediate and delayed benefits on multiple forms of learning in young children (3-5 yrs). By~     probing recall prior to and following mid-day nap or wake intervals, the overarching~     hypothesis is that recent memories are actively processed (as opposed to passively protected)~     by a nap, conferring immediate or delayed (24-hrs) benefits on declarative (Aim 1),~     procedural (Aim 2), and emotional (Aim 3) memories. In two conditions, children will either~     be nap-promoted or wake-promoted midday. Subsequently, performance will be reassessed that~     day as well as the following day.~   "
21482|NCT03285867|"~     Objective: To evaluate the efficacy of preoperative liver stiffness measurement(LSM) by~     FibroScan in predicting the progress of liver fibrosis and prognosis after transcatheter~     arterial chemoembolization (TACE) in hepatocellular carcinoma (HCC).~      Background: Progress of liver fibrosis and liver failure and related poor prognosis after~     TACE which are not completely predictable by current method including Child-Pugh~     Classification. LSM is used to calculate the degree of liver fibrosis and is affected by~     several liver injury, e.g. elevated Alanine aminotransferase（ALT）, Aspartate~     transaminase(AST) and Bilirubin et al. The investigators assume that LSM could be use to~     predict progress of liver fibrosis and adverse effects after TACE in HCC.~      Methods: At least 200 patients will be recruited in this prospective observational study with~     preoperative LSM, demographic, laboratory, radiological and other treatment-related factors.~     Participants will be followed up till death or to the end of study no matter the liver~     failure occurs or not. Data will be analyzed to build a mathematical predicting model.~      Research hypothesis：TACE is related to progress of liver fibrosis and a mathematical model~     with LSM is able to predict the risk of liver failure and prognosis in HCC.~   "
21483|NCT03285854|"~     This is a novel, non-invasive method of assessing Ca balance by natural Ca isotope~     fractionation.~   "
21484|NCT03285841|"~     The multimodal imaging technology, OCT-AFI, will be used to image sites on the cervix, the~     endocervical canal and vulva. The imaging probe is small enough, it can be inserted into the~     endocervical canal for imaging. The probe can also be placed in a conformable holder that can~     be shaped to conform the the folds of the vulva for vulvar imaging. The resultant images will~     be compared to histology images.~      The objectives are to determine~        1. feasibility of the technology in imaging vulva and its capability in detecting vulvar~          intraepithelial neoplasias~        2. feasibility in imaging cervix from endocervical canal to transformation zone to~          ectocervix~        3. if combined OCT with AFI increases the sensitivity of detecting high grade lesions in~          the cervix compared to just AFI alone (previous work was AFI alone).~   "
21485|NCT03285828|"~     Objective is to evaluate the impact of a basic training programme in motivational~     interviewing (MI) for medical students, by comparing the ability of students to promote~     behavioural changes through relationship skills and to conduct a motivational interview~     before and after training.~   "
21486|NCT03285815|"~     A Phase II Randomized Trial of Hypofractionated Proton Therapy in Patients With A Localized~     Prostate Adenocarcinoma~   "
21487|NCT03285802|"~     This is an open-label treatment program following basic prescribing information for patients~     with recurrent UPSC (Uterine Papillary Serous Carcinoma) to provide access to everolimus and~     limited treatment alternatives.~   "
21500|NCT03285620|"~     This is a Phase 1 first-in-human (FIH) study evaluating single and multiple dose~     administration of AL-034 in healthy adult subjects. The aim is to examine the safety~     (including pharmacodynamic [PD] biomarker assessments), tolerability, and pharmacokinetics~     (PK) of increasing single ascending doses (SADs) (Part 1) and multiple ascending doses (MADs)~     (Part 2) of AL-034. The potential food effect will be investigated in healthy adult subjects~     at one or optionally 2 single dose level(s).~   "
21489|NCT03285776|"~     Coordination disorders are common among children that arrive to child development services.~     Children with coordination disorders have impaired proprioceptive sensation and motor~     planning. It is important to carry out a comprehensive assessment of these children in order~     to design an appropriate and effective treatment. There is a lack of an objective and~     standard assessment tools for proprioception and motor planning. Technology based assessment~     tools might offer a solution, as they enable automated and accurate measurement. The purpose~     of this study is to examine the validity and reliability of a new diagnostic computerized~     kit, which was developed for assessment of proprioception and motor planning among children~     with coordination disorders. The hypothesis includes:~        1. Examine the construct validity of the new diagnostic computerized kit (the known group~          procedure). Whether there is a difference in the outcomes between children with typical~          development and children with coordination disorders.~        2. Examine the construct validity of the new diagnostic computerized kit outcomes -~          correlation with the following associated variables: (a) motor skills; (b) sensory~          function; (c) participation in daily activities.~        3. Examine of test-retest reliability of the new diagnostic computerized kit. Whether the~          outcomes are stable in repeated measurements.~      The participants will include fifty children between the ages of 5 to 7 years: 25 children~     with coordination disorders (study group), and 25 children with typical development (control~     group).~      Each child will arrive for an evaluation meeting that includes: (a) the new diagnostic~     computerized kit; (b) two diagnostic sub-tests from the Bruininks-Oseretsky Test of Motor~     Proficiency Second Edition (BOT2) adapted to a tablet; (c) standard and routine tests for~     motor skills (Movement Assessment Battery for Children-2-MABC-2, and two sub-test of the~     Beery-Buktenica developmental test of visual-motor integration- Beery VMI). In addition, the~     children's parents will complete two questionnaires: (a) Sensory Processing Measurement (SPM)~     for sensory function assessment; (b) Participation in Childhood Occupations Questionnaire~     (PICO-Q) for daily participation assessment. After two weeks, ten children from the control~     group will be evaluated once again by the new diagnostic computerized kit for examine~     test-retest reliability.~   "
21490|NCT03285763|"~     This is a Phase III/IV, single-arm, multicenter study of the long-term safety and efficacy of~     atezolizumab treatment in participants with Stage IIIb or Stage IV NSCLC who have progressed~     after standard systemic chemotherapy (including if given in combination with anti-programmed~     cell death protein 1 [anti-PD-1] therapy, after anti-PD-1 as monotherapy, or after tyrosine~     kinase inhibitor [TKI] therapy). The study will consist of a Screening Period, a Treatment~     Period, a Treatment Discontinuation Visit, and a Follow-Up Period.~   "
21491|NCT03285750|"~     G-protein coupled receptor 120 (GPR120) is a G-protein-coupled receptor whose endogenous~     ligands have been identified as long-chain fatty acids. Recently, it has been shown that~     GPR120 expression in human adipose tissue is higher in obese than in lean individuals.~     Interestingly, a GPR120 deficient mouse model presents an unfavorable phenotype when fed a~     high-fat diet with obesity, glucose intolerance and fatty liver, characteristics also found~     in type 2 diabetes (T2D).~      Moreover, in obese subjects, a single nucleotide polymorphism (R270H) has been identified~     that inhibits GPR120 signaling activity.~      The investigators now want to investigate if GPR120 expression in adipose tissue may be~     altered in patients with T2D compared to non-diabetic subjects and might contribute to~     diabetes-associated metabolic changes. Additionally, the investigators want to assess the~     frequency of the R270H mutant in T2D.~   "
21492|NCT03285737|"~     Sarcopenia, the loss in muscle mass with age, is associated with several negative health~     outcomes including cancer, stroke, cardiovascular disease and diabetes. This loss of muscle~     mass remains relatively steady following 50 years of age however it can be accelerated with~     periods of disuse associated with hospitalization, fracture or surgery of the hip or simply~     influenza. Also associated with periods of disuse, is a lack of energy intake as~     hospitalizations often result in undernourishment. The consumption of protein has been shown~     to stimulate muscle growth and therefore the investigators are wondering whether it is able~     to offset the loss of muscle mass associated with disuse. Therefore, the purpose of the study~     is to examine the effects of protein consumption combined with mild caloric restriction on~     changes in muscle mass and function during a period of disuse as well as during a period of~     recovery .~   "
21493|NCT03285711|"~     The primary objective of this study is to evaluate the efficacy of filgotinib and GS-9876 in~     adults with Lupus Membranous Nephropathy (LMN).~   "
21494|NCT03285698|"~     Both DermACELL® and Integra® Bilayer Wound Matrix are indicated for deep soft tissue coverage~     and serve as a biological matrix for cellular migration. The current thinking about the~     utility of these products is to apply over the wound surface and wait until the graft is well~     vascularized (granular bed/neodermis). At that point a split thickness skin graft can be~     applied over this area to cover and heal the wound. This study will determine whether human~     allograft or xenograft will create a durable neodermis that is more supportive of accepting~     of a split thickness skin graft. Patients who do not receive Split thickness skin grafts will~     be assigned to the second cohort for observation of healing rates.~   "
21495|NCT03285685|"~     1. BACKGROUND: Temporomandibular Dysfunction (TMD) is a disease characterized by a set of~          signs and symptoms that may include joint noise, pain in the mastication muscles,~          limitation of mandibular movements, facial pain, joint pain and / or dental wear. Pain~          appears as a very present and striking symptom, with a tendency to chronicity. This is a~          difficult treatment condition often associated with psychological factors such as~          anxiety. Chronic pain involved modifications in the neuronal excitability, therefore,~          the neuromodulation withTranscranial direct current stimulation (tDCS) appears as a~          possible strategy for the treatment. Some studies have shown improvement in subjects~          with chronic pain using tDCS, however, it needs further investigation of its therapeutic~          effect.~        2. PROBLEM: Despite the wide range of strategies used to treat patients with TMD, some~          patients have a temporary and / or unsatisfactory relief response, which generates~          hypotheses that emotional components often underlie treatment refractoriness, and~          development of a memory for pain. Thus, it is evident the need for a therapy that acts~          directly on the central nervous system (CNS). This action can occur through medications,~          however, many individuals are refractory or have side effects such as dependence and /~          or tolerance. In this way, the importance of new treatments involving neuromodulation~          and neuroplasticity mechanisms, such as tDCS, is highlighted, which may become a~          complementary alternative to the different types of treatment already in use. Besides~          corroborating with the need to give preference to reversible and non-invasive~          procedures.~        3. HYPOTHESIS: The investigators believe that the use of anodic tDCS in the treatment of~          patients with TMD presenting with chronic pain will have a positive effect, promoting a~          decrease in painful symptoms through a Central Nervous System (neuromodulation) action~          in comparison to placebo stimulation. Because of the mutual influence between pain and~          psychological factors, it is expected that the analgesic effect will have a positive~          effect on anxiety levels. In addition, it is believed that a more intense analgesic~          effect occurs in the DLPF stimulation group of the cortex compared to the M1 stimulation~          group, since this region demonstrates to be responsible for the processing of the~          emotional component of the pain, often underlying the refractoriness to treatment~        4. AIM: To evaluate and compare the efficacy of anodic tDCS, applied in different cortical~          regions (M1 and DLPFC), in the pain and anxiety levels in individuals with chronic pain~          due muscular TMD.~   "
21496|NCT03285672|"~     The purpose of the study is to determine the efficacy of FP-101 versus placebo for the~     treatment of hot flashes in postmenopausal women.~   "
21497|NCT03285659|"~     Depression is one of the most common conditions among primary care patients. Nevertheless,~     there are several problems in depression diagnosis, clinical management and outcomes. The~     INDI study, which is based in a collaborative care model, aims to improve the management of~     depression in primary care patients. It is intended to be implemented in clinical practice~     within the context of primary care.~   "
22584|NCT03271372|"~     This randomized phase III trial studies how well avelumab works in treating patients with~     Merkel cell cancer that has spread to the lymph nodes and have undergone surgery with or~     without radiation therapy. Monoclonal antibodies, such as avelumab, may stimulate the immune~     system and interfere with the ability of tumor cells to grow and spread.~   "
21501|NCT03285607|"~     In patients with locally advanced hormone receptor positive (HR+)/HER2- breast cancer,~     neoadjuvant chemotherapy produces a pathologic complete response rate (pCR) of only 9-15%,~     and late recurrences often occur despite neoadjuvant chemotherapy. Therefore, there is an~     unmet clinical need to improve the outcomes of these patients. Tumor-associated macrophages~     (TAM) infiltration leads to poor outcomes in breast cancer patients by promoting~     angiogenesis, activating epithelial-mesenchymal transition, degrading the extracellular~     matrix, and suppressing the anti-tumor immune response. Pre-clinical studies, as summarized~     above, have shown that the breast cancer immune microenvironment may be reprogrammed by~     targeting colony-stimulating factor-1 (CSF-1) to decrease TAM infiltration and increase CD8+~     TIL infiltration, in order to foster antitumor immunity and improve response to therapy.~      Here, the investigators propose a phase I dose-escalation study in patients with locally~     advanced HR+/HER2- breast cancer to determine the feasibility of adding MCS110, a CSF-1~     inhibitor, to the standard neoadjuvant chemotherapy regimen of dose-dense doxorubicin,~     cyclophosphamide followed by paclitaxel. The investigators will also include a dose expansion~     cohort for preliminary efficacy analysis and correlative studies. The investigators propose~     that if they can decrease the TAM-induced immunosuppression and TAM-induced chemoresistance~     observed in breast cancer patients, then the patients' own immune system could find and~     destroy the dormant and resistant tumor cells, and combined with enhanced chemotherapy~     efficacy, the investigators will see durable remissions and long term cures.~   "
21502|NCT03285594|"~     Primary Objective:~      To demonstrate the superiority of sotagliflozin dose 1 versus placebo with respect to HbA1c~     (glycosylated hemoglobin) reduction in patients with T2D (type 2 diabetes mellitus) who have~     inadequate glycemic control on basal insulin alone or with OADs (oral antidiabetic drugs).~      Secondary Objectives:~        -  To assess the effects of sotagliflozin dose 1 versus placebo on Fasting Plasma Glucose~          (FPG), body weight, Systolic Blood Pressure (SBP), and HbA1c.~        -  To assess the effects of sotagliflozin dose 2 versus placebo on HbA1c, body weight, FPG,~          and SBP.~        -  To evaluate the safety of sotagliflozin doses 1 and 2 versus placebo.~   "
21503|NCT03285581|"~     The purpose of this pivotal investigation is to evaluate the safety and efficacy of the~     Cutera truSculpt™ radiofrequency (RF) Device for Wrinkle Reduction.~   "
21504|NCT03285568|"~     The purpose of this study is to determine if patients with ER+, human epidermal growth factor~     2 negative (HER2-), advanced breast cancer are receiving dosing adjustments and monitoring~     based on manufacturer recommendations at a tertiary academic medical center.~   "
21505|NCT03285555|"~     The STRATAFIX (Ethicon, Johnson and Johnson, Somerville, New Jersey) Knotless Tissue Control~     suture device is a barbed suture that uses anchor technology to securely engage with the soft~     tissues while also eliminating the need for knots. The anchors, or barbs, are pressed out of~     the device core or formed within the core in a geometric pattern and arranged in a tapered~     manner to allow the device to pass through tissue in the direction toward the needle during~     closure. These knotless tissue control devices are deployed using a continuous technique,~     which is anticipated to be faster and more cost-effective than interrupted suturing.~   "
21506|NCT03285542|"~     In this prospective pilot study examining the superficial closure during total knee~     arthroplasty, active subjects will receive the STRATAFIX Spiral Knotless Tissue Control~     Device for subcuticular closure in addition to DERMABOND PRINEO (Ethicon, Johnson and~     Johnson, Somerville, New Jersey) system for dermal closure. The control subjects will receive~     staples (standard-of-care).~   "
21507|NCT03285529|"~     The STRATAFIX (Ethicon, Johnson and Johnson, Somerville, New Jersey) Knotless Tissue Control~     suture device is a barbed suture that uses anchor technology to securely engage with the soft~     tissues while also eliminating the need for knots. The anchors, or barbs, are pressed out of~     the device core or formed within the core in a geometric pattern and arranged in a tapered~     manner to allow the device to pass through tissue in the direction toward the needle during~     closure. These knotless tissue control devices are deployed using a continuous technique,~     which is anticipated to be faster and more cost-effective than interrupted suturing.~   "
21508|NCT03285516|"~     The primary aim of the current proposal is to test the acceptability and feasibility of a~     group-based transdiagnostic treatment, termed Safety Aid Reduction Treatment (START),~     delivered to rural Veterans. The anticipated results of the proposed study include: 1) START~     will be both acceptable and feasible to Veterans and mental health care providers, alike and~     2) START will lead to meaningful reductions in symptoms of anxiety and depression.~   "
21509|NCT03285503|"~     This study assess pharmacokinetics and safety of multi-administration of Aripiprazole IM~     Depot formulation at doses of 400mg in patients with schizophrenia.~   "
21510|NCT03285490|"~     This Phase III study is designed to evaluate the activity and safety of KX2-391 Ointment in~     adult subjects when applied to an area of skin containg 4-8 stable, clinically typical~     Actinic Keratosis lesions on the face or scalp.~   "
21511|NCT03285477|"~     This Phase III study is designed to evaluate the activity and safety of KX2-391 Ointment in~     adult subjects when applied to an area of skin containg 4-8 stable, clinically typical~     Actinic Keratosis lesions on the face or scalp.~   "
21512|NCT03285464|"~     Does a rotary based triplanar exercise intervention that utilizes the trunk as a proximal~     lever, strengthen the hip and alter dynamic LE alignment in running females?~   "
21513|NCT03285451|"~     In this study, submental ultrasound during awake and simultaneous under Drug-induced sleep~     endoscopy is applied in the diagnostic workup of obstructive sleep apnea patients. The aim is~     to assess the tongue base thickness during awake and sleep with different head positions. By~     correlation with Drug-induced sleep endoscopy findings, more parameters could be used for~     evaluation and management of upper airway collapse in obstructive sleep apnea patients.~   "
21535|NCT03285152|"~     The purpose of this study is to test any good and bad effects of an experimental diet, called~     a ketogenic diet, in endometrial cancer. A ketogenic diet is one that is very low in~     carbohydrates (simple and complex sugars). The goal of this diet is for the body to go into a~     state of ketosis. Ketosis is when the body does not have enough sugar for energy so it burns~     stored fats which create acids called ketones, which can be used for energy. Researchers hope~     to learn whether or not a ketogenic diet is well-tolerated and safe to eat before surgery in~     endometrial cancer patients.~   "
21514|NCT03285438|"~     Patients with unprovoked venous thromboembolism (VTE) or VTE associated with persistent risk~     factors have a high risk of recurrence after stopping anticoagulation. In these patients,~     international guidelines recommend indefinite anticoagulation. However, prolonged use of~     warfarin or DOAC at therapeutic dose is associated with a significant risk of bleeding.~     Consequently, it has been hypothesized that extended anticoagulation at lower dosage might be~     as effective as and safer than full dose of anticoagulation. However, low-dose warfarin (INR~     1.5-2) was less effective and not safer than conventional dose warfarin (INR 2-3).~      Low dose of DOAC has the potential to validate this hypothesis. In a first randomized trial~     comparing full-dose or low-dose apixaban with a placebo during an additional one year of~     anticoagulation in patients where physicians were uncertain for prolonging anticoagulation~     (Amplify-extension trial), low-dose apixaban was more effective than placebo without any~     major concern regarding safety and possibly as effective as and safer than full-dose~     apixaban; in a second randomized trial comparing full-dose or low-dose rivaroxaban with~     aspirin, during an additional one year of anticoagulation in patients where physicians were~     uncertain for prolonging anticoagulation (Einstein-Choice trial), low-dose rivaroxaban was~     more effective than aspirin without any major concern regarding safety and possibly as~     effective as and safer than full-dose rivaroxaban. However, these two studies were not~     designed and powered to demonstrate non-inferiority on efficacy and superiority on safety of~     a reduced dose of DOAC versus a full dose DOAC and the selected population did not have~     strong indications for indefinite anticoagulation. Thus, there is currently no evidence to~     recommend a reduced dose rather than a full dose of DOAC for extended therapy in patients at~     high risk of recurrent VTE. Consequently, a randomized trial comparing low-dose DOAC with~     full-dose DOAC therapy in patients at high risk of recurrent VTE is needed and justified.~      Main hypothesis:~      After VTE at high risk of recurrence initially treated during 6 to 24 uninterrupted months, a~     reduced dose of DOAC will be non-inferior to a full dose of DOAC in terms of recurrent VTE~     during extended anticoagulation phase.~   "
21515|NCT03285425|"~     CLN6 is a rare, neurodegenerative disease that causes progressive loss of acquired skills~     with motor delay, visual loss, seizures and ataxia. The investigators propose a natural~     history study of this rare disorder since it is currently unknown. It is important to~     understand disease progression in CLN6 disease to be able to judge therapeutic efficacy as~     emerging therapies like gene therapy become available.~   "
21516|NCT03285412|"~     This research study is studying a drug as a possible treatment for ER-positive Breast Cancer~      The drug involved in this study is:~      -Ribociclib~   "
21517|NCT03285399|"~     Between February 2008 and February 2009, 500 infant-mother pairs in Bhaktapur, Nepal were~     randomly selected in this nutritional survey. The dietary intake, nutritional status of~     several nutrients, growth, and breastfeeding habits were measured in both the women and their~     infants.The objective of this first phase was to estimate the intake and status of several~     nutrients in relation to breastfeeding. These mother-child pairs were revisited around the~     child's fifth birthday when growth, diet, and neurodevelopment was measured. The objective of~     this phase was to create a cohort study where factors in infancy could be related with health~     outcomes and development 5 years later.~   "
21518|NCT03285386|"~     Critical power is an important threshold in exercise physiology, and is an important~     determinant of the ability to tolerate high-intensity exercise. The ability to tolerate such~     exercise is drastically impaired in certain chronic conditions, such as type 1 diabetes.~     Whilst the most important physiological factors that determine critical power have yet to be~     determined, previous work from our laboratory suggests that it is related to the speed of~     oxygen uptake at the onset of exercise. This study will look to utilise priming exercise as~     an intervention to improve the speed of these oxygen uptake kinetics, and thus critical~     power and exercise tolerance in individuals with type 1 diabetes. We hypothesize that oxygen~     uptake kinetics will be faster and critical power will be higher when exercise is performed~     with compared to without a prior bout of high-intensity priming exercise in a population of~     individuals with type 1 diabetes.~   "
21519|NCT03285373|"~     The primary objective of the study is to describe the usage of NOACs in patients with NVAF,~     in the hospital setting, based on the baseline characteristics at the time of first NOAC~     initiation.~   "
21520|NCT03285360|"~     Will the use of Bioactive glass with air abrasion technology (Sylc) compared to Fluoride~     Varnish (Biflourid 10) affects the degree of pain in patients complaining from~     hypersensitivity due to non-carious lesions?~   "
21521|NCT03285347|"~     The current study adresses the effect of two different computer-based cognitive trianing~     programmes on attention and executive functions in patients with Parkinson's disease.~   "
21522|NCT03285334|"~     enrollment of the patient after diagnosis, radiographic evaluation, and signing the informed~     consent.~      allocation of the patient to either intervention or control group. After anaesthesia and~     access cavity, the first root canal sample will be taken. Endodontic treatment will be~     completed in one visit. The second root canal sample will be taken. Patients will be asked to~     evaluate their postoperative pain level using VAS scale at 6, 12, 24 hours, and daily up to 5~     days. Patients will record the number of analgesics if any taken.~   "
21523|NCT03285321|"~     This study is an open label, multicenter, randomized phase II trial of consolidation~     immunotherapy with either nivolumab alone or the combination of nivolumab and ipilimumab~     following concurrent chemoradiation in patients with unresectable stage III NSCLC.~   "
21524|NCT03285308|"~     This study will evaluate the safety and efficacy of Relamorelin compared to placebo in~     patients with diabetic gastroparesis. Patients will report daily severity scores of their~     diabetic gastroparesis symptoms.~   "
21525|NCT03285282|"~     Several regional anesthesia have been shown to improve postoperative outcomes in many~     studies. The transversus abdominis plane (TAP) block provides anesthesia to the abdominal~     wall by introducing local anesthetic to the anterior rami of the spinal nerve roots. This~     work evaluates the analgesic effects gained after performing thoracolumbar interfacial plane~     block (analogous to the TAP block but intended for the back) which targets the sensory~     component of the dorsal rami of the thoracolumbar nerves in patients undergoing back~     surgeries.~   "
21526|NCT03285269|"~     The current study plants to create a patient registry of patients who present to the~     emergency department with signs and symptoms of shock and evaluate the ability of a~     multi-step cardiopulmonary ultrasound protocol to determine the need for fluid therapy.~   "
21527|NCT03285256|"~     Prospective memory is the ability to implement an intention to the future (e.g. remember to~     take medication, attend a scheduled meeting), and has receive little attention in addiction.~     The investigators propose that prospective memory plays a critical, yet unrecognized, role in~     major human behavior change such as that required in addiction treatment. This study will~     determine the preliminary efficacy of prospective memory training in improving memory and~     executive functions while reducing illicit drug use in methadone patients. Participants will~     be randomly assigned to one of three conditions: an experimental memory training program or~     one of two comparator memory training programs.~   "
22585|NCT03271359|"~     This is a randomized clinical trial comparing eye movement desensitization and reprocessing~     (EMDR) to progressive counting (PC) for volunteers from the community who are distressed by~     the memory of a motor vehicle accident. Participants will be assigned to the geographically~     nearest therapist, and then randomized to treatment condition.~   "
21528|NCT03285243|"~     Emergence delirium/emergence agitation (ED/EA) is a behavioral phenomenon of unclear etiology~     consisting of short lived behavioral changes that can be both traumatic to families and pose~     a safety risk to patients and staff. ED is characterized by a variety of presentations,~     including crying, excitation and agitation, that occur during the early stage of recovery~     from general anesthesia, generally in the first 30 minutes. Emergence delirium occurs in~     children of all ages following an anesthetic with halogenated agents (e.g.~     sevoflurane/isoflurane) with or without having undergone a surgical procedure (e.g. MRI~     patients). Presently, the treatment for ED is to revert the patient back to a hypnotic state~     mainly with sedatives so that they may reset themselves postulating that by re-inducing a~     hypnotic state, the brain has time to resolve this issue. The hypothesis of this study is~     that during ED, there is failure of organized EEG activity, especially alpha wave activity~     and that by enhancing alpha activity, the incidence of ED may be reduced without the need for~     additional pharmaceuticals which may be costly, delay recovery and are not without adverse~     effects specifically cardiopulmonary depression through the use of blue monochromatic light.~   "
21529|NCT03285230|"~     The French E3N cohort was initiated in 1990 to investigate the risk factors associated with~     cancer and other major non-communicable diseases in women.~      The participants were insured through a national health system that primarily covered~     teachers, and were enrolled from 1990 after returning baseline self-administered~     questionnaires and providing informed consent. The cohort comprised nearly 100 000 women with~     baseline ages ranging from 40 to 65 years.~      Follow-up questionnaires were sent approximately every 2-3 years after the baseline and~     addressed general and lifestyle characteristics together with medical events (cancer,~     cardiovascular diseases, diabetes, depression, fractures and asthma, among others). The~     follow-up questionnaire response rate remained stable at approximately 80%.~      A biological material bank was generated and included blood samples collected from 25 000~     women and saliva samples from an additional 47 000 women.~      Ageing among the E3N cohort provided the opportunity to investigate factors related to~     agerelated diseases and conditions as well as disease survival.~   "
21530|NCT03285217|"~     Cirrhosis is a late stage of hepatic fibrosis caused by many forms of liver diseases and~     conditions, such as hepatitis and chronic alcoholism. The World Health Organization (WHO) has~     reported that this condition accounts for 1.8% of all deaths in Europe (170,000 deaths/year).~      Patients with cirrhosis are characterized by severe metabolic alterations, which converge in~     a malnutritional state. Malnutrition encompasses glucose intolerance, chronic inflammation,~     altered gut microbiota, reduced muscle mass (sarcopenia), as well as loss and dysregulation~     of adipose tissue (adipopenia). Malnutrition is the most frequent complication that adversely~     affects the outcomes of cirrhotic patients. Yet, despite its clinical repercussions and~     potential reversibility, there are no effective therapies because our limited understanding~     of the mechanisms underlying this altered metabolism.~      β-hydroxy β-methylbutyrate (HMB) is a naturally produced substance regarded as safe and~     effective in preventing muscle loss during chronic diseases. Previous studies have indicated~     some beneficial effects of HMB itself or its parent metabolite, leucine, on adipose tissue,~     glucose intolerance, inflammation, and gut microbiota. This study aims to translate those~     beneficial effects to cirrhotic patients. The investigators hypothesize that HMB can improve~     cirrhosis-related metabolic abnormalities through its pleiotropic effects. The goals of this~     study are: i) to perform a randomized clinical trial to evaluate the efficacy of HMB,~     administered as nutritional supplementation, on clinical symptoms of cirrhosis.~      ii) to uncover the precise metabolic pathways that underlie HMB action, with a special focus~     on muscle, adipose tissue, and gut microbiota.~   "
21531|NCT03285204|"~     The aim of this study is to obtain an early biomarker of amyotrophic lateral sclerosis and~     Friedreich's Ataxia which allows to diagnose the disease in an initial stage and to follow up~     the patient with optic coherence tomography, a fast, non-invasive and comfortable method~   "
21532|NCT03285191|"~     Rheumatoid arthritis (RA) is a chronic, systemic autoimmune disease affecting the joints and~     can lead to joint pain, swelling, redness and stiffness and can cause deformity, loss of~     strength and immobility. This cross-sectional qualitative study aims to explore the burden of~     established RA by conducting semi-structured Concept elicitation (CE) interviews (60 minutes~     duration) and real-time data capture task. The conceptual model developed from this data will~     be used to support the development of GSK3196165, a recombinant human monoclonal antibody~     (mAb) targeted for the treatment of RA. The CE interviews will explore the subject experience~     of RA and will collect information about symptoms, disease impact on functioning and health~     related quality of life (HRQoL), and treatment experiences/impacts of the condition and the~     language used by subjects to describe them. Following the CE interview, subjects will be~     asked to complete a brief symptom ranking exercise where they will need to rank how~     bothersome each RA symptom is and how important it would be to improve with treatment on a~     1-5 numerical rating scale (NRS). After the interviews, the real-time disease experience of~     subjects will be captured by the real-time data capture app-based activity over a period of 7~     days. Approximately 30 English-speaking subjects from the United States (US) with RA who are~     inadequate responders of conventional synthetic disease-modifying anti-rheumatic drugs~     (csDMARDs) and/or (bDMARDs) will participate in the interviews and of these, 10 subjects will~     be offered the opportunity to participate in the real-time data capture sub study.~   "
21533|NCT03285178|"~     The primary objective of the 1701-202 STRONG SCD study is to evaluate the safety and~     tolerability of 3 dose levels of IW-1701 compared with placebo when administered daily for~     approximately 12 weeks to patients with stable SCD. Exploratory objectives include evaluation~     of PK as well as evaluation of the effect of IW-1701 on symptoms of SCD, health-related~     quality of life, and biomarkers of pharmacodynamic (PD) activity.~   "
21534|NCT03285165|"~     Serial transcranial Doppler (TCD) exams in healthy volunteers and in animal models showed a~     strong linear relationship between middle cerebral artery (MCA) flow velocity (FV) and~     dexmedetomidine infusion. The concomitant elevation of pulsatility index (PI) indicates~     vasoconstriction of the cerebral vasculature as the most profound underlying mechanism.~   "
21589|NCT03284450|"~     There is a paucity of studies investigating exercise-induced muscle damage (EIMD) in females~     and only one in response to dance-type exercise. This study aimed to firstly elucidate the~     physiological profile of EIMD following a dance-specific protocol, and second to compare the~     magnitude of damage to that experienced following a sport-specific protocol in physically~     active females.~   "
21536|NCT03285139|"~     Postpartum depression (PPD) affects up to 20% of women and has profound effects on mothers~     and their infants. Unfortunately, fewer than 15% of women with PPD receive evidence-based~     care. This is at least partly due to significant difficulties faced by women in accessing~     cognitive behavioural therapy (CBT), a preferred 1st line treatment. In Ontario at present,~     there is a significant lack of personnel trained to deliver CBT. This study will utilize a~     randomized controlled trial design (with wait list controls) and recruit 70 participants to~     determine if women with a past history of PPD (i.e., lay peers) can be trained to deliver~     effective group CBT to women with current PPD. If peers can be trained to provide effective~     CBT, more women would receive treatment and the burden of PPD on women, families, and the~     healthcare system would be significantly reduced.~   "
21537|NCT03285126|"~     The purpose of this study is to determine eligibility for the future clinical trial of gene~     therapy in adults with late-onset Pompe disease.~      This screening protocol will enroll up to 20 adults patients (>=18 yo) with late-onset Pompe~     disease. Study assessments include review of medical history, vital signs, physical~     examination, muscle function testing, lung function testing, blood and urine collection,~     serum pregnancy test and ECG.~      The study results will be collected to perform descriptive statistical analysis and used to~     determine eligibility for the proposed clinical trial of gene therapy in the future.~   "
21538|NCT03285113|"~     This study is a prospective, single-arm, open label, single center pilot study to confirm the~     safety of a ultrahigh frequency DRG stimulator in patients with chronic lower limb pain. The~     actual trial length is 5 days. Pts will be given ultrahigh frequency pulse stimulation, and~     VAS will be obtained after 3-4 hours of each stimulation.~   "
21539|NCT03285100|"~     Background: Elastin is a unique protein providing elasticity, resilience and deformability to~     dynamic tissues, such as lungs and vasculature. Elastin fibers are characterized by their~     high affinity for calcium. However, calcified elastin is more prone to the degrading effects~     of proteases and, in turn, partially degraded elastin has an even higher affinity for~     calcium. A disturbed balance between proteases and anti-proteases is a major underlying~     mechanism in the development of chronic obstructive pulmonary disease (COPD). Virtually the~     only protein that can protect elastin from calcification is matrix Gla-protein (MGP), which~     needs vitamin K for its activation. In COPD patients, a lower vitamin K status is found when~     compared to control subjects and an inverse association exists between vitamin K status and~     elastin degradation. In addition, vitamin K status is lower and elastin degradation is~     accelerated in Vitamin K antagonist (VKA) users.~      VKAs are widely used. Nowadays, an increasing number of patients uses direct oral~     anticoagulants (DOACs), which do not influence vitamin K status. The hypothesis of this study~     is that discontinuation of VKAs results in an improved vitamin K status and deceleration of~     elastin degradation. In order to test this hypothesis, an observational pilot study will be~     conducted in which the change in elastin degradation- quantified by plasma desmosine~     concentrations - in patients who discontinue use of VKAs will be used as primary endpoint.~      Study design: Observational study. Study population: A total of 30 VKA users who will~     discontinue the use of VKAs. Elastin degradation rate (quantified by plasma desmosine levels)~     and vitamin K status (quantified by measuring plasma levels of dephosphorylated~     uncarboxylated (dp-uc)MGP) will be measured during the use of VKAs and approximately 6 months~     after discontinuation of VKAs. Furthermore, the VKORC1 polymorphisms will be determined.~      Main study parameters: The primary endpoint is the change in the rate of elastin degradation~     quantified by the plasma desmosine assay. Secondary endpoints are the change in vitamin K~     status quantified by measuring plasma levels of dp-ucMGP, the relation between desmosine and~     dp-ucMGP and differences of desmosine and dp-ucMGP levels among subjects with different~     polymorphisms of the vitamin K 2,3-epoxide reductase complex 1 (VKORC1) gene.~   "
21540|NCT03285087|"~     Hypotension and bradycardia have been commonly associated with dexmedetomidine therapy,~     occurring in 13% to 68% and 1% to 42% of patients, respectively. The variability in reported~     incidence may be partially attributed to inconsistent definitions and study populations. The~     significance of this hemodynamic instability is not only highlighted by its high incidence~     but also the need for corrective interventions. In one study, hemodynamic instability~     requiring clinical intervention occurred in nearly one third of ICU patients receiving~     dexmedetomidine. Moreover, patients who experienced dexmedetomidine‑associated hypotension~     had a higher mortality rate than those who did not.~   "
21541|NCT03285074|"~     Unlike the general population, a higher body mass index (BMI) is associated with greater~     survival among patients with chronic kidney disease (CKD). However, obesity is defined as~     excess body fat that associated with clearly elevated health risks according to the World~     Health Organization. In addition, muscle wasting is prevalent among CKD subjects. Thus, we~     hypothesized that different definition of obesity, based on BMI or body fat percentage, might~     have different impact on clinical outcomes among CKD population.~   "
21542|NCT03285061|"~     This study aims to survey the drug disposal methods of orthopedic foot and ankle patients~     with excess pain medication following and operation. The study is a randomized control trial~     comparing the use of FDA approved at home disposal methods to current clinical methods of~     recommending disposal at medication drop off locations.~   "
21543|NCT03285048|"~     This study is to determine the safety, feasibility and acceptability of an 8-week cognitive~     remediation training (CRT) in patients treated for cancer. The secondary objective of the~     study is to estimate the effect size of CRT in improving neurocognitive functioning and~     quality of life. This is a single-arm proof of concept study. Patients treated for cancer~     with persistent cognitive complaints will be recruited from the outpatient clinic of the VA~     Comprehensive Cancer Center, West Haven, CT, Yale Medicine, and greater New Haven~     community.The active treatment phase will be followed by an assessment at the conclusion of~     treatment to evaluate changes in cognitive function and quality of life. Participants will be~     invited back to participate in a final follow-up assessment 2 months later.~   "
21544|NCT03285035|"~     This is a single arm prospective study to determine the effect of cryoablation combined with~     chemotherapy on the quality of life of patients with non resectable esophageal or~     gastroesophageal cancer.~   "
21545|NCT03285022|"~     The study aim to evaluate the difference between the effect of zinc modified glass ionomer~     and conventional glass ionomer on the success of partial caries removel technique~   "
21560|NCT03284827|"~     This trial is to compare the efficacy of NOAC(Novel Oral Anticoagulants) with edoxaban vs.~     dual antiplatelet therapy (DAPT) for prevention of leaflet thrombosis (documented by cardiac~     CT imaging) and cerebral embolization (documented with brainDiffusion-weighted (DW) magnetic~     resonance (MR) imaging) in patients without an absolute indication for chronic oral~     anticoagulation (OAC) after successful transcatheter aortic valve replacement(TAVR).~   "
21561|NCT03284814|"~     The single-center, randomized, open-label, three-period crossover bioavailability study will~     include 21 subjects who will test three CoQ10 formulations. Subjects will test 3 formulations~     of single dose CoQ10 within first 3 weeks to assess bioavailability, which will be followed~     with 2 weeks of continuous administration of one of study formulations to demonstrate and~     assesse multiple-dose profile of CoQ10.~   "
21546|NCT03285009|"~     This project is a consequence of the research chair project studying the same phenomenon in~     adult volleyball players. The project will make use of and be part of the routine medical~     screening that is taken by the young players of the first degree of the Leuven Volleyball~     School, Belgium. All young players must undergo a routine medical investigation and movement~     screening. This is obliged by the law. The current project will use these data. Outcome~     parameters will be used to advice the trainer staff of the school to adjust their training~     interventions. This is normal routine too as the involved medical department has been~     advising the school for many years. Players will be followed up for 6 weeks. After those 6~     weeks, the movement screening will be repeated to evaluate the change in the different~     outcome parameters. This last screening is not part of a normal routine as players normally~     are investigated more in a subjective way. The medical team and school want to change that~     routine.~      Data will be used to further improve training modalities and sports performance and reduce~     injury risk in these young athletes.~   "
21547|NCT03284996|"~     Doppler sonography provides an easily applicable, non-invasive, and well-established method~     for investigating renal morphologic characteristics and measuring vascular resistance in the~     renal parenchyma. Doppler are of strategic importance in providing qualitative and~     quantitative information about the renal vasculature, which can be obtained through the~     assessment of the resistive index.~   "
21548|NCT03284983|"~     The investigators wish to determine how suture spacing (5 mm vs. 10 mm) affects cosmetic~     outcome and development of train tracking in wounds. Linear wounds with sutures spaced~     closer together may not be as cosmetically appealing when compared to those that have larger~     spacing between sutures. Suturing closer together constricts blood flow and increases tension~     that ultimately results in more tissue necrosis and a less appealing outcome. The~     investigators also aim to conclude if 5 mm or 10 mm suture spacing results in less~     complications.~   "
21549|NCT03284970|"~     This study will be a single center, retrospective, pilot study to determine the effect of~     Rebif (interferon beta-1a) and Tecfidera (dimethyl fumarate) on infections on total~     lymphocyte counts, grade of lymphopenia, Cluster of Differentiation 4 (CD4) and Cluster of~     Differentiation 8 (CD8) counts and ratios in subjects aged 50 years and above with~     Relapsing-Remitting Multiple Sclerosis (RRMS).~   "
21550|NCT03284957|"~     Primary Objectives:~      Dose Escalation: Part A (SAR439859 monotherapy); Part C (combination of SAR439859 with~     palbociclib)~        -  To determine the maximum tolerated dose (MTD) and recommended dose (RD) of SAR439859~          based on the dose-limiting toxicity (DLT) observance in monotherapy (Part A), and in~          combination with palbociclib (Part C)~      Dose Expansion: Part B (SAR439859 monotherapy); Part D (combination SAR439859 with~     palbociclib)~        -  To assess antitumor activity by Objective Response Rate (ORR) at the SAR439859~          recommended dose in monotherapy (Part B), and in combination with palbociclib (Part D)~      Secondary Objectives:~        -  To characterize the overall safety profile of SAR439859 as monotherapy (Parts A and B),~          and in combination with palbociclib (Parts C and D)~        -  To characterize the pharmacokinetic (PK) profile of SAR439859 as monotherapy (Parts A~          and B), and of SAR439859 in combination with palbociclib (Parts C and D), as well as of~          palbociclib in combination with SAR439859 (Parts C and D)~        -  To evaluate antitumor activity of SAR439859 as monotherapy (Part A), and in combination~          with palbociclib (Part C) as well as the disease control rate (DCR) in Parts A, B, C,~          and D~        -  To evaluate ORR and DCR (Complete Response [CR], Partial Response [PR] and Stable~          Disease [SD] ≥6 months) in Parts B and D according to the estrogen receptor 1 (ESR1)~          gene mutational status (mutant and wild type)~        -  To evaluate residual estrogen receptor (ER) availability with [(18)F] Fluoroestradiol~          Positron Emission Tomography (FES PET) scan (Part A)~   "
21551|NCT03284944|"~     STRATUS will evaluate the use of small-volume (soft-draw) blood collection tubes for~     laboratory testing in reducing anemia and transfusion in intensive care unit patients without~     significant adverse consequences. This is a simple, cost-neutral intervention that could~     improve the quality of patient care and reduce the harms of frequent laboratory testing.~   "
21552|NCT03284931|"~     This study will assess the pharmacodynamic effects of SAGE-217 in approximately 42 healthy~     adult subjects using an insomnia model.~   "
21553|NCT03284918|"~     The purpose of the study is to investigate the cholesterol lowering efficacy of a cereal~     based snack bar with added plant stanol ester when used between meals as part of a habitual~     diet by subjects with mild to moderate hypercholesterolemia.~   "
21554|NCT03284905|"~     Efficacy of probiotics on acute stress~   "
21555|NCT03284892|"~     This study is to develop and test the accuracy of a two-step post-extubation dysphagia~     screening and the effects of PED Care intervention on reducing time to resume oral intake,~     rates of penetration and intervention at 10 days postextubation, and incidences of 30-day~     aspiration pneumonia in adult patients with prolonged intubation (≥48 hours) under a~     randomized controlled trial (RCT) design.~   "
21556|NCT03284879|"~     To evaluate the safety and efficacy of OTEZLA in actual clinical settings of use in patients~     with Psoriasis vulgaris that is with an inadequate response to topical therapies and~     Psoriasis arthropathica~        1. Planned registration period 2 years~        2. Planned surveillance period for 4 years from 6 months after launch~   "
21557|NCT03284866|"~     This randomized phase III trial studies how well human papillomavirus (HPV) vaccine therapy~     works in reducing high-grade cervical lesions in patients with human immunodeficiency virus~     (HIV) and HPV. Vaccines made from HPV peptides or antigens may help the body build an~     effective immune response to kill the HPV virus and prevent cervical lesions from developing~     or coming back after being removed.~   "
21558|NCT03284853|"~     The study is intended to test the effectiveness and safety of Netarsudil / Latanoprost 0.02%~     / 0.005% Ophthalmic Solution, relative to GANFORT® for lowering of intraocular pressure (IOP)~     in patients with elevated intraocular pressure~   "
21559|NCT03284840|"~     To obtain up-to-date data on nutrient intakes in adults, a national dietary survey - the EU~     Menu study will be conducted during 12 consecutive months in 2017/2018, providing data on the~     consumption of foods and enabling the assessment of energy and macronutrient intakes.~     Participating subjects will be invited to NUTRIHEALTH study for assessment for micronutrient~     status (focusing into vitamin D, folic acid, vitamin B12, and iron) and medical examination,~     in which thyroid size will be aslo measured, to investigated thyroid epidemiology in~     Slovenia.~   "
21564|NCT03284775|"~     Pituitary adenoma can be difficult to cure with approximately a third of patients in~     contemporary series' undergoing incomplete resection. Over the last decade or so a handful of~     groups have described the use intraoperative ultrasound to improve resection. Although~     limited, these proof-of-concept studies suggest intraoperative ultrasound is a safe and~     effective technological adjunct to transsphenoidal surgery for pituitary adenoma.~      In this prospective development study 30 adult patients will undergo transsphenoidal surgery~     for pituitary adenoma with prototype intraoperative ultrasound devices. The primary outcomes~     will be technical feasibility and device safety. The secondary outcomes will be complete~     versus incomplete radiological resection, endocrinological remission, the occurrence of~     postoperative complications, operating time, and length of stay.~   "
21565|NCT03284762|"~     The purpose of the study is to collect additional information of Xarelto treatment in routine~     clinical practice. Patients affected by atrial fibrillation and who will get Xarelto as a~     prophylactic treatment against stroke and systemic embolism (Stroke Prevention in Atrial~     Fibrillation) will be observed.~   "
21566|NCT03284749|"~     The most common complication of vaginal delivery is perineal tearing with a prevalence of 85%~     and 70% will need suturing. The caesarean section rate worldwide is rising and the rate in~     Croydon University Hospital is in the region of 25% of all deliveries. One in ten women will~     develop a wound infection of their perineal tear or caesarean section wound. Wound infection~     can cause pain, dehiscence, delayed wound healing, prolonged hospital stay, readmissions and~     interfere with a woman's ability to nurture their baby and enjoy motherhood. Copper has shown~     to have strong antimicrobial properties, with the ability to kill various bacteria including~     MRSA. It has also been shown that copper promotes new blood vessel formation and therefore~     enhance wound healing. This study is to investigate the effect of copper impregnated~     dressings and maternity pads on wound infection. Women will be randomised for a wound~     dressing or maternity pad with (study group) or without copper (control group). Both the~     clinician and the woman will be blinded to the randomised group. Wound infection will be~     assessed via a telephone questionnaire after 7, 14 and 30 days after delivery. When wound~     infection is suspected, based on the questionnaire, a swab of the wound site will be taken to~     detect the causative bacteria.~   "
21567|NCT03284736|"~     Study Title: Effects of Guided Tissue Regeneration on the Healing of Through & Through~     Periradicular Lesions - A Randomized Controlled Study~      Rationale: Through and through defects found to be difficult to heal without GTR~     intervention. Various studies has been done either with graft or without graft but no~     randomized controlled trial has been done on resorbable membrane(GTR) in through and through~     lesion.~      Aim & Objectives: To evaluate the effect of resorbable collagen membrane in the healing of~     through & through lesion.~      Setting: Study was conducted in Post Graduate Institute Of Dental Sciences, Rohtak in the~     department of Conservative Dentistry & Endodontics.~      Study Design: Randomized Controlled Trial~      Time Frame: March 2016 to October 2017~      Population / Participants: Patients of age 16 years (male/female) and above were enrolled in~     the study.~      Inclusion Criteria: Patients of age 16 years and above, -ve response to vitality test, failed~     previous root canal treatment with purulent discharge, failed previous surgery, recurrent~     episode of purulent discharge.~      Exclusion Criteria: Unrestorable tooth, fractured /perforated roots, serious medical illness,~     smokers, pregnant females and lactating mothers, grade 3 mobile teeth, the need for~     antibiotic prophylaxis prior to dental care.~      Sample size: 30 patients (15 patients in each group)~      Methods: Clinically and radiographically diagnosis of lesion, vitality check by EPT,~     preoperative evaluation by bleeding on probing, clinical attachment level, gingival marginal~     position & pocket depth. Surgical procedures will be carried out under operating microscope~     with 8 × 16 magnification by following standardized treatment methods.~      Outcome measures: Follow up of patients were carried out at 3, 6, 9 & 12 months and outcome~     measures were compared with same method done pre operatively and described as Complete~     healing, incomplete healing (scar tissue), uncertain healing, unsatisfactory healing~     (failure).~      Statistical method: Data will be analyzed with suitable statistics method.~   "
21568|NCT03284723|"~     The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses~     of PF-06804103 in patients with HER2 positive solid tumors. The study will expand to look at~     the selected dose in patients with breast cancer, gastric cancer and non-small cell lung~     cancer~   "
21569|NCT03284710|"~     The purpose of this study is to evaluate the safety and immune response to an HIV clade C~     vaccine and to an MF59- or alum-adjuvanted clade C Env protein in healthy, HIV-uninfected~     adults.~   "
21570|NCT03284697|"~     Aim of the study was to evaluate and compare clinical and radiographic success with MTA and~     calcium hydroxide as direct pulp capping materials in cariously exposed mandibular molars.~      Study was conducted in Post Graduate Institute of Dental Sciences, Rohtak in department of~     Conservative Dentistry & Endodontics. Mature permanent mandibular molars with reversible~     pulpitis exhibiting occlusal pulp exposure from primary dental caries were included in the~     study. After excavation of caries and obtaining pulpal hemostasis, patients were randomly~     allocated into two groups- MTA and Calcium Hydroxide. Pulp was capped with respective~     allocated material and then tooth in both groups were restored according to standard~     protocol.~   "
21571|NCT03284684|"~     The aim of this study was to determine the kinetics of perioperative circulating DNA in three~     types of cancer. This first step will enable further studies comparing the potential impact~     of certain techniques or anesthetic products on cancer surgery.~   "
21572|NCT03284671|"~     The purpose is to show that bifocal tDCS with an anodal stimulation on the orbitofrontal~     cortex and cathodic stimulation on supplementary motor areas is an effective treatment for~     patients with resistant and severe obsessive compulsive disorders.~   "
21573|NCT03284658|"~     Development of a new MS-based biomarker for the early and sensitive diagnosis of Tyrosinemia~     type 1 from plasma~   "
21602|NCT03284281|"~     This study will determine the impact of Transcutaneous Vagus Stimulation(TVNS) and autonomic~     modulation of inflammation in patients admitted with  acute heart attack.~      After admission for acute heart attack or myocardial infarction patients will be~     randomized to either TVNS or placebo and their blood samples will be collected at different~     time points during admission and post discharge.~      Blood samples will be analyzed for various markers of inflammation.~   "
21603|NCT03284268|"~     Phase I study, single site, open label with dose escalation, for evaluate safety and the~     oncolitic Adenovirus VCN-01 activity in patients with refractory retinoblastoma.~   "
21604|NCT03284255|"~     The Bioheart Randomized Controlled Trial is a prospective multicentred paralleled study,~     which will enroll 430 patients and randomized 1:1 to study group and control group. aim to~     compare the efficacy and safety of Rapamycin Drug-Eluting Bioresorbable Coronary Stent System~     to XIENCE stent in the treatment of patients with up to two coronary lesions.~   "
21574|NCT03284645|"~     More than 150,000 babies became infected with HIV in 2015 alone. When HIV drugs are started~     before or early in pregnancy, HIV positive women can give birth to HIV negative baby. This is~     possible because HIV drugs can reduce the amount of the virus in the body to the extent that~     they become undetectable by the time of delivery and during the breastfeeding period.~     However, some women do not start taking these drugs on time because they become infected~     during pregnancy or lactation. This leads to detectable virus at the time of delivery and~     puts the baby at risk of becoming infected. Also, the amounts of HIV drugs in the body have~     to be at certain levels for them to work effectively. But findings from some research have~     recently showed that pregnancy increases the rate at which the body removes some HIV drugs~     used to prevent the transfer of HIV from mother to child. While this may not cause any~     problem in women with no detectable virus before pregnancy, it may affect the rate at which~     the HIV virus is removed from the body in those starting treatment late and may put the baby~     at risk. This project will investigate whether the changes in drug exposure caused by~     pregnancy or other factors have any effect on the rate at which the HIV virus is removed from~     the body. HIV positive pregnant women and those who recently delivered will be recruited from~     different hospitals and follow up will be until breastfeeding ends. The investigators will~     not be involved in treatment decisions and the primary care provider will be responsible for~     prescribing antiretroviral regimen based on current guidelines. Samples will be collected to~     measure levels of the virus and the drugs in three fluids that transfer the virus to the~     baby: blood, genital fluid, and breastmilk. The HIV status of the babies will be monitored~     until they stop breastfeeding.~   "
21575|NCT03284632|"~     This study will examine the level of toxicity of e-cigarette use compared to smokers and~     nonsmokers including inflammation markers, toxicant and carcinogen exposure. Additionally,~     the study will look at the effect of varying voltage levels for e-cigarette users.~   "
21576|NCT03284619|"~     Investigational device is the Magnetic resonance imager linear accelerator. Five (5) patients~     with bone metastases will be treated with palliative intention in this study. The goal is to~     confirm the pre-clinically demonstrated technical accuracy and safety of the newly developed~     MR-Linac in the clinical setting.~   "
21577|NCT03284606|"~     A majority of people undergoing rehabilitation following a stroke have a deficit of the~     dorsal flexors of the foot. The implementation of rehabilitation techniques in accordance~     with the recommendations of learned societies is not sufficient to compensate for this~     deficit. Also Kinesio Taping's method of Dr. Kenzo Kase has caught our attention by its~     action on muscle, joint, circulatory and pain functions.~      The use of taping would increase the duration of stimulation of the muscles of the~     dorsiflexors of the foot which would facilitate the motor recovery.~      Data from the literature do not support the conclusion that taping is effective, but no~     studies evaluating the efficacy of this technique in the foot-lift deficiency of the~     hemiplegic patient have been found.~      The investigators hypothesize that the use of taping in conjunction with common~     rehabilitation for hemiplegic patients following a stroke improves the stimulation of the~     muscles of the dorsiflexors of the foot with a positive impact on the walking.~   "
21578|NCT03284593|"~     The treatment of older patients with acute myeloid leukemia that is secondary to previous~     myelodysplastic syndrome, myeloproliferative neoplasm, or prior cytotoxic exposure remains~     unsatisfactory. We compared patients treated with intensive chemotherapy or azacitidine~     within two centres.~   "
21579|NCT03284580|"~     The objective of the present study is to evaluate the effectiveness of two home-based~     ergonomic intervention programs compared to a control group on the quality of life of~     caregivers of post-stroke patients~   "
21580|NCT03284567|"~     Late effects of breast cancer treatment are widely reported including deteriorating fitness,~     fatigue, loss of muscle and bone mass, and increased body fat percentage. Exercise~     interventions may ameliorate a number of these effects including fatigue, fitness and improve~     quality of life. However only limited knowledge exists on the potential of novel~     interventions and settings, such as sports outside the hospital setting, to improve late~     effects of breast cancer treatment. The 'Football Fitness After Breast Cancer' (FF ABC) study~     is a randomized trial comparing the effects of a football training intervention with standard~     treatment approaches on fitness, bone mineralization, body composition, muscle strength,~     blood pressure, and patient-reported outcomes in women treated for breast cancer.~   "
21581|NCT03284554|"~     A double-blind, randomized crossover design with four arms including three experimental~     conditions and placebo will be applied. After having successfully completed screening~     procedures, eligible participants will be invited to four separate test days. The test days~     cannot be within the same week, however there is no upper limit for days in between, as long~     as the participants remain weight stable and do not change diet or physical activity level.~     Significant changes in diet, physical activity level (evaluated by the sub-investigator) or~     weight change ±3 kg over the course of the study (from screening to completion of the last~     test day) results in exclusion of that subject.~   "
21582|NCT03284541|"~     Young gay, bisexual, and other men who have sex with men (YMSM) are the only risk group in~     which rates of new HIV infections are on the rise. There has been a relative dearth of~     research dedicated to understanding these health disparities between gay/bisexual and~     heterosexual youth, and even less has focused on identifying factors that might promote~     resilience against negative health outcomes. Understanding both risk factors and processes of~     resilience is critical in developing efficacious interventions to improve health in this~     population.~      Through a grant from the National Institutes of Health, the investigators completed formative~     research with young male couples. Qualitative interviews identified preferences for~     couples-based intervention format and content. While coupled YMSM expressed some interest in~     HIV prevention, they were most interested in building relationship skills. Coupled YMSM~     preferred group-based interventions in order to meet and learn from other couples but had~     concerns about discussing personal topics in groups. Quantitative analyses found that the~     rate of condomless sex in couples increased from adolescence to young adulthood. Further, the~     influence of older partners, partner violence, and drinking before sex were strongest in~     emerging adulthood. Informed by these, the investigators developed 2GETHER, which aims to~     reduce HIV transmission risk in couples by enhancing relationship functioning. 2GETHER is a~     four session program. The first two sessions are group sessions aimed at skills building, and~     the second two sessions are individualized couple sessions aimed at skills implementation.~     Modules address communication skills, coping with stress (both general and sexual~     minority-specific stress), relationship sexual satisfaction, and HIV transmission risk within~     the dyad and with outside partners. 2GETHER was designed to address HIV transmission risk in~     couples regardless of HIV status; couples learn to use behavioral and biomedical approaches~     to prevent both HIV acquisition (e.g., HIV testing, condom use, pre-exposure prophylaxis) and~     transmission (e.g., medication adherence to reduce viral load), with an overarching emphasis~     on the health of the couple.~      The investigators completed a pilot trial of 2GETHER with funding from Northwestern~     University. The pilot trial enrolled 57 couples (N=114) and demonstrated feasibility,~     acceptability, and preliminary efficacy of 2GETHER. This pilot trial used a non-randomized~     pre-/post-test design because the goal was to evaluate feasibility, acceptability and~     preliminary effects in a large number of diverse couples to inform a future efficacy RCT.~     Post-test occurred 2 weeks post-intervention, or ~2 months post-baseline. The pilot trial~     recruited a diverse sample of couples in less than one year and each program module receive~     high ratings of acceptability during post-sessions evaluation and an exit interview. At the~     2-week post-test, the investigators observed significant decreases in HIV risk behavior,~     improvements in motivation to reduce HIV risk, and improvements in relationship investment.~      The current study will conduct a randomized controlled trial (RCT) to test the efficacy of~     2GETHER, a novel couples-based intervention for young men who have sex with men (YMSM) that~     aims to reduce HIV transmission risk by optimizing relationship functioning. This RCT will be~     implemented online; both the experimental and control condition will be administered via~     video-conferencing technology to couples across the United States. The investigators will~     conduct this RCT with 200 dyads (total individual N=400), who will be randomized to receive~     the 2GETHER intervention or existing public health practice (PHP). PHP differs depending on~     the HIV status of individuals in the dyad. Couples in which both members are HIV-negative~     will receive the single-session Couples-Based HIV Counseling and Testing (CHCT) protocol.~     Couples in which both members are HIV-positive will receive the single session Life-Steps~     medication adherence protocol. Couples with discordant HIV statuses will receive both~     interventions jointly.~   "
21583|NCT03284528|"~     The histology of the placenta of newborn infants with perinatal asphyxia and~     hypoxic-ischaemic encephalopathy is analysed. There will be an evaluation if placenta could~     be a biomarker for neurodevelopmental outcome at 18-24 months of age.~   "
21584|NCT03284515|"~     A study investigating gene expression profiles in pregnant women in response to a pertussis~     containing vaccination in pregnancy.~   "
21585|NCT03284502|"~     This study evaluates the safety, tolerability and pharmacokinetics of cobimetinib and HM95573~     in patient with locally advanced or metastatic solid tumors.~   "
21586|NCT03284489|"~     The purpose of this observational epidemiological study is to investigate the management and~     the complications associated with pancreatitis. Datas will be analysed to answer pre-defined~     scientific projects and to improve management of these conditions.~   "
21587|NCT03284476|"~     The purpose of this observational study is to investigate the management and the~     complications associated wtih surgically treated peritonitis.~      Data will be analysed to answer pre-defined scientific projects and to improve management of~     these conditions.~   "
21588|NCT03284463|"~     This study is designed to evaluate the safety and efficacy of oral glibenclamide in acute~     ischemic stroke patients who under intravenous rt-PA thrombolysis.~   "
21590|NCT03284437|"~     The purpose of this study is to see how early cognitive training (participation/involvement~     in activities to stimulate the brain) in the Intensive Care Unit (ICU) affects the number of~     patients who experience delirium (confusion) and cognitive impairment (problems with~     thinking). Reports have shown that 30% to 80% of all ICU patients will have some type of~     cognitive impairment: remembering, paying attention, solving problems, organizing, and~     working on complex tasks for some time after they leave the hospital.~      Occupational therapy will do an assessment after an order is received from the doctor. The~     patient will be randomly placed into one of two groups. If the patient is in group A then~     they will continue with occupational therapy as normal. If the patient is assigned to group B~     then they and the family will have access to an activity cart found there in the ICU unit,~     directed by the nurses. The family will work with the patient on a daily basis to complete~     activities that are appropriate for the patient based on the occupational therapist's~     assessment. All patients in the study will receive medical care as usual.~      Information about the patient's recovery in the hospital will be collected. In addition,~     patients and/or their family member will complete surveys at 6 months and 1 year after~     enrollment to see how they have recovered and if there are continuing issues. The two groups~     of patients, those who received the early cognitive training and those who did not, will be~     compared statistically to see if there are any differences in how well they recovered. Since~     this intervention involving family members working with the patient has not previously been~     evaluated, the study will also examine the feasibility of conducting these activities in the~     ICU setting.~   "
21591|NCT03284424|"~     The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475)~     in adult participants with recurrent or metastatic cutaneous Squamous Cell Carcinoma (R/M~     cSCC) that is not amenable to surgery and/or radiation and/or systemic therapies.~   "
21592|NCT03284411|"~     This study will characterizes the effects of amplitude on subject satisfaction and pain~     relief in subjects being treated by SCS.~   "
21593|NCT03284398|"~     The primary study objective is to assess the rates of blood stream infection (BSI) from the~     use of Three-Chamber Bags (e.g., SmofKabiven®, Kabiven®, others) compared to Hospital~     Compounded Bags (HCBs) in patients requiring parenteral nutrition in Spanish hospitals.~   "
21594|NCT03284385|"~     This phase II trial studies how well adavosertib works in treating patients with~     SETD2-deficient solid tumors that have spread to other places in the body. Adavosertib may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
21595|NCT03284372|"~     Among the 15 million people with food allergies in the U.S., adolescents experience the~     highest risk of adverse events. Yet, there are few evidence-based strategies to improve food~     allergy management in adolescents. In a cohort multiple randomized controlled trial, this~     study will include two experiments to test the effectiveness of text message reminders and~     incentives to encourage epinephrine-carrying.~   "
21596|NCT03284359|"~     Difficulties enrolling patients in randomized clinical trials (RCTs) have long been~     recognized as a major barrier to successful evaluation of medical interventions. This is~     particularly problematic among intensive care unit (ICU) trials, of which more than one-third~     do not reach target enrollment. Under-enrollment and selective enrollment reduce RCTs'~     abilities to answer the research questions, thereby degrading the trials' scientific value~     and ethics.~      Current evidence suggests that financial incentives can ethically increase study enrollment,~     but this approach can pose large up-front costs to researchers. However, several nonmonetary~     behavioral interventions, or nudges, may offer novel and easily scalable approaches to~     increase enrollment in RCTs.~      The investigation team propose a 3-arm RCT in 5 ICUs at Penn to test the relative~     effectiveness of 2 different nudges on enrollment rates. Investigators hypothesize that a~     bundle of nudges during recruitment will increase enrollment rates compared to usual~     recruitment procedures, and that requiring participants to make a choice to participate or~     not, with enhanced information about each option, will increase enrollment.~      Investigators will enroll 273 critically ill patients' surrogate decision~     makers(participants) to engage in recruitment procedures for a simulated RCT comparing two~     oxygen saturation targets among mechanically ventilated patients. Investigators will also~     measure participants' assessment of risk of the simulated trial after the informed consent~     process. This work will provide the first empirical evidence regarding the efficacy of two~     inexpensive, scalable nudges to potentially augment enrollment and reduce costs of future~     clinical trials.~   "
21597|NCT03284346|"~     This randomized pilot clinical trial studies how well circuit, interval-based aerobic and~     resistance exercise works in targeting metabolic dysregulation in stage I-III breast or~     prostate cancer survivors. Circuit, interval-based aerobic and resistance exercise may help~     to improve cardiovascular fitness, weight loss, healthy lifestyle behaviors, and muscle~     strength in breast or prostate cancer survivors.~   "
21598|NCT03284333|"~     The purpose of this pivotal investigation is to evaluate the efficacy and safety of the~     Cutera enlighten multi-wavelength 532 nm and 1064 nm Nd:YAG picosecond pulse duration laser~     and an investigational micro-lens array (MLA) handpiece attachment for improvement of acne~     scars.~   "
21599|NCT03284320|"~     The objectives of this trial is to evaluate efficacy and safety of treatment with Trabectedin~     in a large cohort of German patients with soft tissue and bone sarcomas.~   "
21600|NCT03284307|"~     This study will be a single-site, controlled, unblinded study at the University of Wisconsin~     to examine changes in the electroencephalogram during anesthesia and waking.~   "
21601|NCT03284294|"~     The objective of the study is to evaluate the influence of vitamin D supplementation on Serum~     Brain Derived Neurotrophic Factor level and cognitive function in schizophrenia treated with~     atypical antipsychotic. Methods: The investigator will use randomized controlled trial~     design. 40 chronic schizophrenia patients with vitamin D insufficiency or deficiency treated~     with atypical antipsychotic, will be randomly assign (1:1 ratio) to receive either daily oral~     cholecalciferol 2000 IU or placebo for 8 weeks. Assessment of BDNF serum and cognitive~     function will be performed at baseline and after 8 weeks period.~   "
21617|NCT03284086|"~     This study compares peak oxygen uptake (VO2peak) and exercise efficiency in upper-body poling~     versus arm crank ergometry in trained able-bodied and paraplegic participants.~   "
22586|NCT03271346|"~     The purpose of this study is to track outcomes of the investigator's therapy approach with~     children of separation/divorce who have been exposed to parental conflict.~   "
21605|NCT03284242|"~     This study will enroll individuals who have end stage renal disease and who are undergoing a~     solitary kidney transplant. This study is investigating/evaluating the safety and~     effectiveness of collecting, expanding and infusing a specific certain type of immune cell~     known as Regulatory T cells (Treg cells) to renal transplant recipients who are using~     Zortress (Everolimus) as immunosuppressive therapy.~      Treg cells, once they have been expanded in the laboratory to help prevent kidney rejection.~     Treg cells are collected from a participant's blood through a procedure called apheresis.~     Treg cells are a type of white blood cells that are able to suppress the activity of other~     immune cells responsible for organ rejection. The investigator plans to enroll 12~     participants at the University of Kentucky.~   "
21606|NCT03284229|"~     This is a Prospective, Open label, Non-randomized, Single-Arm, Multicenter Study to Evaluate~     the Procedural Safety and Efficacy of ELCA® in Treatment of Patients with Single or~     Multivessel Coronary Artery Disease (CAD). Up to 30 patients will be enrolled at up to 05~     Indian study sites. Patients will be followed from enrollment through 30 days ± 7 days for~     the effectiveness and safety endpoints at the study centre.~   "
21607|NCT03284216|"~     This study will determine whether exposure to short-term high blood glucose levels impairs~     exercise-induced adaptations in glucose tolerance, and whether the pattern of high blood~     glucose levels plays a role.~   "
21608|NCT03284203|"~     The investigators' central hypotheses predict that the handheld spirometry device will be~     feasible for inpatient and at-home use, and is equally efficacious at determining lung~     function when compared to traditional, bedside spirometry measurements. To test these~     hypotheses, the investigators propose the following specific aims:~      Specific Aim 1: Determine the correlation of SpiroPD handheld spirometry measurements with~     bedside Koko spirometry lung function.~      Hypothesis: Correlation between the two lung function tests will be substantial for both~     hospitalized and ambulatory patients.~      Specific Aim 2: To determine the feasibility, adherence, and preliminary management efficacy~     of home SpiroPD testing.~      Hypotheses: (1) Patients will demonstrate substantial adherence to daily home spirometry~     testing; (2) medication adherence will increase significantly in patients who are adherent to~     daily home spirometry testing; (3) acute care utilization will decrease significant in~     adherent patients.~   "
21609|NCT03284190|"~     In a multi-national population-based cohort, the investigators want to compare the clinical~     course and clinical outcome of elderly patients (≥70 y/o) compared with younger patients (<~     70 y/o) with acute subdural hematoma treated surgically. An improved understanding of the~     clinical outcome and the prognostic factors of acute subdural hematomas would allow~     physicians to make better decisions about treatment options in traumatic ASDH in the elderly~     population.~   "
21610|NCT03284177|"~     To investigate the safety of C13-CAC and the relationship among C13-CAC breath test, gastric~     pH, and the improvement of symptoms by switching PPI in PPI resistant GERD patients~   "
21611|NCT03284164|"~     This is a Phase 1 study to investigate the effects of Renal Impairment on the~     pharmacokinetics of Tenofovir exalidex~   "
21612|NCT03284151|"~     Focused stereotactic radiation treatment of localized prostatic adenocarcinoma. in order to~     quantify the delay between the focused treatment and the salvage procedure.~   "
21613|NCT03284138|"~     First rank symptoms are core symptoms of schizophrenia. the investigators want to offer an~     integrative approach to better understanding of the mechanisms involved in the first rank~     symptoms and therefore, in schizophrenia, as well as the neuronal modulation mechanisms~     obtained by rTMS. It will be to pass a functional magnetic resonance imaging (fMRI) at rest~     for healthy volunteers, and for patients before and after rTMS modulation, to view brain~     structures activated in the resting state network, and in order to study~        1. the difference of the resting-state network between healthy volunteers and people with~          schizophrenia,~        2. if the response to rTMS boost can be predicted by resting-state network of patients~          before treatment and~        3. if rTMS changes activations in the brain of patients. This will ultimately provide rTMS~          as a treatment of first rank symptoms.~   "
21614|NCT03284125|"~     The facial paralysis is a frequent disease causing important functionals swallowing~     dysfunctions. The purpose of our study was to evaluate the improvement of the swallowing~     disorders after surgery by lengthening temporalis myoplasty (LTM) in the facial paralysis.~      This prospective study has realised on the following of patients affected by facial paralysis~     treated by LTM. Self-administered questionnaires and clinics tests had realized to analyze~     three components oh the oral phase of the swallowing ( drooling, mastication and handicap).~     The evaluations was realized before the surgery and at 3 and 6 months after .~   "
21615|NCT03284112|"~     The purpose of this research study is to evaluate the knowledge of parents and children with~     respect to dementia symptoms, risk factors, and response before and after an interactive~     dementia education program that uses music and dance to enhance a health education curriculum~     at 1-week and 3-months after the intervention.~   "
21616|NCT03284099|"~     Background: Non-dipping (ND), defined as a <10% decrease in blood pressure (BP) during sleep,~     is an independent significant predictor of cardiovascular outcome in hypertensive patients. A~     few anti-hypertensive medications, including angiotensin receptor blockers (ARBs) and~     angiotensin converting enzyme inhibitors (ACEIs), may normalize dipping if administered at~     night. Chinese data are scarce and there are no prospective studies on cardiovascular~     outcomes in Chinese patients.~      Aim: To determine if the bedtime administration of ACEIs and ARBs is more effective at~     normalizing ND than morning administration. As a pilot project, the feasibility of recruiting~     hypertension patients in primary care for ambulatory blood pressure monitoring (ABPM) and~     conducting a clinical trial will be evaluated such that future larger randomized trials can~     be planned to determine treatments for ND.~      Method: Fifty patients diagnosed with essential hypertension who are receiving either ACEIs~     or ARBs and diagnosed with ND will be randomized to take ACEIs or ARBs either early morning~     or before bedtime. A follow-up 48-hour ABPM will be performed after 4-6 weeks to examine~     post-treatment changes in BP and ND status.~      Outcome: The primary outcome of this proposed study is the proportion of ND at 6 weeks;~     secondary outcomes will include (i) mean awake and asleep SBP/DBP of 48-hour duration (ii)~     feasibility of this pilot study will be assessed by recruitment and dropout rates during the~     study period.~      Potential: This pilot study will provide the basis for a future larger randomized controlled~     study to further examine the treatment for ND in primary care.~   "
21618|NCT03284073|"~     More than a decade ago, uterus transplantation (UTx) as a highly experimental procedure was~     the treatment which had been developed for women suffering from absolute uterine factor~     infertility (AUFI) [uterus absence (congenital and surgical), or an abnormality (anatomic and~     functional)].~      In Egypt, People's religions, current ethical and legal backgrounds make the option of~     live-donor uterus transplantation appealing rather than alternative pathways to parenthood.~     Thus, its clinical application for the first time in Egypt should be initiated after an~     extensive review and analysis of literature for UTx technology development in the world, and~     for further possible contributions to future prospects by Egypt proposed UTx project team~     which will participate in our study.~   "
21619|NCT03284060|"~     Social cognition refers to mental operations that enable people to perceive, interpret~     constantly changing social informations. These processes allow people to rapidly,~     effortlessly and flexibly perceive and interpret rapidly-changing social information, and~     respond appropriately to social stimuli. Besides, this ability gives meaning to the actions~     of others. Impairments in this field may largely underlie social dysfunctions and reduce~     adaptive skills. Moreover, social cognitive disabilities contribute more or less directly to~     behavioral disturbances and psychiatric symptoms The RC KID program involves a variety of~     exercises in a paper and/or pencil or a computerized format or role playing and a strategy~     coaching approach. RC KID targets the emotion recognition and social interaction.~      A little cartoon character (a pirate), is supposed to be very friendly and kind toward~     children. The pirate will accompany them throughout the program for an effective and positive~     reinforcement. The main goal of RC KID is to adjust to children's difficulties in daily~     life.~      Moreover, since the cognitive remediation benefit is complex to apply in daily life, the~     program is based on a metacognitive strategy.~      After a complete neuropsychological assessment and a psychoeducational session (with the~     child and the parents), 16 1-h-sessions of cognitive remediation with the therapist are~     proposed. Each session is composed of three parts: (1) computerized tasks focusing on~     specific emotion recognition components (20 min). RC KID is composed of 2 modules : Emotion~     recognition and social interaction. These tasks contain photo or video. (2) pen and paper or~     role playing tasks focusing on the same processes (20 min) (3) a proposal of a home-based~     task (during 20 min). Weekly, home tasks are proposed to the child and analyzed with the~     parents and the therapist. Indeed, home exercises are useful to promote the transfer of~     strategies to daily life and their subsequent automation. The heterogeneity of cognitive~     deficits in 22q11.2 deletion necessitates an individualized cognitive remediation therapy. In~     this regard, RC KID seems to be a promising tool.~   "
21620|NCT03284047|"~     This is a two part study to measure and observe the efficacy of botulinum toxin A for the~     treatment of gummy smiles.~      Part A will randomly compare three different doses of botulinum toxin type A~     (abobotulinumtoxin A) for the treatment of upper anterior gummy smile with larger gingival~     exposure (> 4 mm).~      Part B will assign one of two doses of botulinum toxin type A for participants with smaller~     gingival exposure (< 4 mm).~      Follow-up visits with photography will occur 4 and 12 weeks after their treatment. Subjects~     currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will~     be considered for enrollment.~      This study is a pilot study designed to determine feasibility of this procedure.~   "
21621|NCT03284034|"~     This is a prospective randomized controlled study comparing the efficacy of cryolipolysis~     versus ATX-101 (deoxycholic acid) for the treatment of upper back fat. Participants currently~     living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be~     considered for enrollment. The treatment sites are the right and left upper back fat areas.~     The right and left sides of the upper back fat will be randomly assigned (1:1) to receive~     cryolipolysis, while the contralateral side will receive ATX-101.~      This study was a pilot study designed to determine feasibility of this procedure.~   "
21622|NCT03284021|"~     This is a pilot study to evaluate the effect of the 1550 nm fractional erbium-glass laser in~     patients with nonscarring alopecias. Participants currently living in the Chicago~     metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment.~     Participants will receive 5 sessions of laser, 30 days apart, to the area of alopecia on the~     scalp. Follow-up is at 150 days.~      This study was a pilot study designed to determine feasibility of this procedure.~   "
21623|NCT03284008|"~     The aim of this study is verify the effectiveness of manual maneuver associated with~     stretching exercises in the treatment of Axillary Web Syndrome.~   "
21624|NCT03283995|"~     The classic physiopathology of cardiogenic shock is explained by a systolic ventricular~     failure, responsible for a decrease in cardiac output associated with high systemic vascular~     resistances (SVR). This theory is currently challenged in light of the data collected in the~     SHOCK study, which assessed outcome of early revascularization versus initial medical~     stabilization, in cardiogenic shock following myocardial infarction.13 A sub-study~     highlighted depressed SVR in the population with ischemic cardiogenic shock, related to a~     systemic inflammatory response syndrome.14 Furthermore, mean FEVG was 30% in the SHOCK~     trial,13 with a similar distribution with post myocardial infarction heart failure patients~     without signs of shock.15-19 Thus, alteration of myocardial contractility can be only~     moderate in cardiogenic shock and isn't the only cause responsible for the hemodynamic~     instability.20 Recent studies suggest the important roles of the peripheral vascular system~     and neurohormonal system in the genesis and prolongation of cardiogenic shock.12 Vasodilation~     caused by nitrous oxide synthase activation27 explains the absence of compensating~     vasoconstriction observed during the SHOCK trial13, and leads to decreased systemic and~     coronary perfusion, thus increasing myocardial ischemia and initial ventricular dysfunction.~     28,29 Cotter et al. conducted an interesting study of hemodynamic evaluation of various~     cardiac conditions where they observed a significant variability in the peripheral vascular~     status, with systemic vascular resistances collapsed in certain patients (similar to those~     observed in septic shock) and rather close to normal or very high resistances in other~     patients.21 However these data were obtained from a selected group of patients without~     differentiating the etiology of cardiogenic shock. Finally, the majority of available studies~     were limited to cardiogenic shock whose etiology was myocardial infarction.~      Therapeutic management of cardiogenic shock is based in first intention on an inotropic~     support by Dobutamine.11,23 However, better outcomes on contractility and microcirculatory~     state have been observed with the use of a vasopressor support by Norepinephrine, suggesting~     the importance of SVR decreasing in genesis of cardiogenic shock.14,24 Recent reviews showed~     very few data on inotropic treatment and association with vasopressor support,22 hence the~     low level of recommendations in current guidelines.11,23~      So far it is crucial to accurately characterize hemodynamic status and in particular the~     systemic vascular resistance for patients with cardiogenic shock. Important variabilities in~     hemodynamic profiles observed in Cooter's trial could explain the difficulty in defining an~     optimal therapeutic strategy.~      the investigators hypothesize that the hemodynamic profile, particularly SVR, of patients~     with cardiogenic shock is different depending on their etiology. Ischemic cardiogenic shock~     should be characterized by lower SVR, in relation to a major role of systemic inflammatory~     response syndrome. On the contrary, non-ischemic cardiogenic shock could be associated with~     normal or elevated SVR, and thus could explain the variability in distribution of SVR.~   "
21625|NCT03283982|"~     The investigators aim to conduct a registry-based, randomized controlled trial to investigate~     if the robotic platform for minimally invasive ventral hernia repair with intraperitoneal~     onlay mesh (IPOM), when compared to the laparoscopic platform, will influence on early~     postoperative pain scores, wound morbidity (surgical site infections, surgical site~     occurrences and surgical site occurrences requiring procedural intervention), ventral hernia~     recurrence rate and abdominal wall-specific quality of life.~   "
21644|NCT03283735|"~     This study protocol comprises three phases. The first two phases will be nationwide and aim~     to evaluate the prevalence and patterns of polypharmacy and assess the barriers and~     facilitators of deprescribing perceived by older adults, as well as their willingness to be~     deprescribed and to self-medicate. The third and last phase will be a non-pharmacological~     randomised clinical study to measure the impact of enablement of older adults in their~     willingness to be deprescribed and related quality of life.~   "
21626|NCT03283969|"~     This proposal seeks to build upon studies, including ours, on the favorable effects of~     California strawberries on vascular health. Freeze dried strawberry powder (FDSP) contains a~     number of nutrients that may have beneficial effects on plasma lipids and vascular function,~     as well as on the composition of the gut microbiota; changes in the gut microbiota can in~     turn have secondary positive effects on the vascular system as well as on other physiological~     functions that are important determinants of health and disease. The proposed project will~     seek to determine the influence of short-term FDSP intake on the gut microbiota composition,~     and select microbial-derived metabolites from stool, serum and urine, and their relationship~     to microvascular function. Secondary outcomes will include the influence of the FDSP on~     circulating levels of nitrate and nitrite and trimethylamine oxide (TMAO) as markers of~     vascular health that are influenced by both dietary intake and the oral and gut microflora,~     with blood pressure as an additional vascular outcome.~   "
21627|NCT03283956|"~     To evaluate efficacy and safety profile of DC bead® TACE in patients with hepatocellular~     carcinoma in Taiwan.~   "
21628|NCT03283943|"~     It is postulated that focal sensitizing radiotherapy may potentiate the effectiveness of~     durvalumab. The purpose of this study is to test the safety and tolerability of 2 different~     dose levels of focal sensitizing radiation therapy given with durvalumab.~   "
21629|NCT03283930|"~     This study examines a computer-based attention bias modification training as an augmentation~     of individual cognitive behavioral therapy for pediatric anxiety.~      All participants will receive interviews to assess how they are doing in general, including~     general mood, degree of nervousness, and behavior. Each participant and one of his or her~     parents will be interviewed separately and together. Participants are asked to complete tasks~     involving problem-solving, attention, and emotion that involve looking at pictures,~     remembering things, testing reaction times, and making simple choices.~      Participants with anxiety will first meet with a psychologist for 12 weeks of individual~     cognitive behavioral therapy. In addition, participants will be randomly and blindly assigned~     to receive either an active computer-based attention bias modification training task or an~     inactive/placebo version of this task, administered as part of their therapy treatment. The~     active training is thought to help anxiety whereas the inactive training is thought to have~     no effect.~      The purpose of this part of the study is to understand the best way to help children and~     adolescents who are having problems with anxiety. However, more research is needed to find~     the best way to help such children and adolescents. During and after the treatment, each~     participant will complete verbal and written symptom ratings.~      Those who have not improved by the end of the study will be offered other treatment for 1 to~     3 months, and the clinicians will help with finding subsequent aftercare. Those who improve~     with treatment will continue therapy at NIH until an outside physician is able to assume~     responsibility for monitoring medication.~      FOR MORE INFORMATION REGARDING THIS STUDY CALL THE CORE PHONE NUMBER: 301-496-5645~   "
21630|NCT03283917|"~     The goal of this clinical research study is to learn if the combination of daratumumab,~     ixazomib, and dexamethasone at standard doses can be given safely to patients with amyloid~     light chain (AL) amyloidosis.~      Researchers also want to learn the recommended dose of the study drug combination.~      This is an investigational study. Daratumumab and ixazomib are FDA approved and commercially~     available for the treatment of another type of blood cancer called multiple myeloma, although~     not in combination. Dexamethasone is FDA approved and commercially available to help prevent~     or treat certain side effects. The combination of daratumumab and ixazomib with dexamethasone~     is not FDA approved for the treatment of AL amyloidosis. It is currently being used for~     research purposes only.~      The study doctor can explain how the study drugs are designed to work.~      Up to 20 participants will be enrolled in this study. All will take part at MD Anderson.~   "
21631|NCT03283904|"~     The aim of AS:Sk is to improve physical activity levels and health-related outcomes of~     children from the Skelmersdale area of West Lancashire through a school-based physical~     activity multi-component intervention.~   "
21632|NCT03283891|"~     Haemodialysis (HD) patients constitute a vulnerable population with considerable health~     needs. They are often older persons with comorbid chronic conditions. Despite the substantial~     technical care they receive, these patients indicate that the quality of the human~     relationship that develops with nurses-the pivotal element in the care this population~     receives-can become therapeutic. This feature of the human relationship constitutes the~     cornerstone of the humanistic practice (caring practice) that all nurses should adhere to.~     However, according to some authors, such practice tends to fade over time. In 2012, a pilot~     study allowed to test an educational intervention based on Watson's Theory of Human Caring,~     the aim of which was to optimise nurses' humanistic practices. The intervention, first~     developed in Quebec and adapted in Switzerland by a committee of experts, was delivered to a~     group of nine HD nurses (Canton of Vaud, Switzerland) and evaluated. Preliminary results~     (qualitative and quantitative) showed the intervention to be highly feasible and acceptable.~     Moreover, in terms of preliminary outcomes, participating nurses appeared to strengthen their~     caring attitudes/behaviours toward HD patients post-intervention. Quantitative analyses of~     patients' questionnaires showed that HD patients perceived significant changes in nurses'~     caring attitudes/behaviours and maintained their level of quality of life (QoL) over time,~     which is a definite gain for this population. In light of these positive results, it is~     important to pursue this line of investigation in order to examine more accurately the~     intervention's effects on both nurses and patients. To this end, the investigators propose~     conducting a mixed-methods cluster randomised controlled trial (RCT) to assess the effects of~     an educational intervention to strengthen humanistic practice among nurses working in HD~     units in French Switzerland, on perceived quality of the nurse-patient relationship (NPR),~     nurses' team cohesion, nurses' quality of working life (QoWL), and HD patients' QoL.~     Knowledge acquired in the course of the study will contribute to strengthen nurses'~     humanistic practice, a key factor in HD patients' QoL.~   "
21633|NCT03283878|"~     The Antibiotic Prophylaxis in Patients Undergoing Elective Total Knee Arthroplasty (TKA):~     Multi-Center Trial is a study that will compare the effectiveness of various perioperative~     strategies for antibiotic delivery as prophylaxis for periprosthetic joint infections (PJI)~     and surgical site infection in elective primary TKA. The investigators hypothesize that a~     single dose of prophylactic antibiotic administered within 60 minutes before the incision is~     not an effective way to prevent PJI in elective primary total knee arthroplasty (TKA). The~     investigators also hypothesize that the prolonged delivery (24 hours) of antibiotic~     prophylaxis after surgery does not further reduce the incidence of PJI in elective primary~     TKA.~      Duke University is the only site recruiting both primary total knee arthroplasty and~     unilateral knee arthroplasty.~   "
21645|NCT03283722|"~     The objective of this registry is to gather data on the clinical outcomes of Medtronic mitral~     repair products (Profile 3D™ and CG Future® annuloplasty systems) in the approved intended~     use up to 12 months from the day of procedure~   "
38156|NCT03067220|"~     To assess if a virtual out patient clinic via a telephone review was an acceptable and safe~     alternative to a clinic attendance for a broad range of general surgical patients discharged~     following a hospital admission.~   "
21634|NCT03283865|"~     Caudal blocks are one of the most commonly performed regional anesthetics in children and are~     performed daily for a host of infra-umbilical surgical procedures. A caudal block is an~     epidural injection, most commonly of local anesthetic into the epidural space as accessed via~     the sacral hiatus. In children, the sacral hiatus is a normally occurring aperture in which~     the epidural space may be accessed with extremely minimal risk; as neural tissue ends more~     proximally. Due to this measure of safety, caudal blocks are preferred in children when~     compared with standard lumbar epidurals. Caudal blocks are performed blindly using palpation~     and tactile feedback to assess if the medication is being administered in the correct~     location. As a result of blind injection, administration of local anesthetic totally or~     partially outside of the correct site can often be unnoticed or identified after a~     significant volume has already been injected. With the potential for toxicity of local~     anesthetic, this may result in either the inability to give a complete dose or an~     unintentional and often unnoticed sham block incorrect site of injection.~   "
21635|NCT03283852|"~     Disorders of growth, puberty and sex development can have genetic causes. The exome analysis~     could detect new mutations responsible for these disorders and the frequency of these~     mutations in these disorders, their association with other malformations.~   "
21636|NCT03283839|"~     To evaluate the effects of the temporomandibular disorder (TMD) and its therapeutic care on~     postural control in somato-sensory and visual sensitization compared to control subjects~     matched on age, sex and lifestyle.~      Parameters will be estimated by measures realized before the therapeutic care of the TMD~     (T0), then 2, 3 and 5 months after the starting care, both in TMD patients and control~     subjects. To evaluate also the effects of the TMD and its therapeutic care on balance control~     in various contexts of multi-sensory stimulation, orientation function, pain and tinnitus.~   "
21637|NCT03283826|"~     This is a multicenter, open-label, two-population, single-arm study with a sequential~     dose-escalation and dose-expansion in adult subjects with progressive forms of multiple~     sclerosis (MS) and an in adult subjects with relapsed remitting multiple sclerosis (RRMS).~   "
21638|NCT03283813|"~     Myoinositol (MI) and D-chiro inositol (DCI) are isomeric forms of inositol that were found to~     have insulin-like properties, acting as second messengers in the insulin intracellular~     pathway; both of these molecules are involved in the increasing insulin sensitivity of~     different tissues to improve metabolic and ovulatory functions. Myoinositol is the~     predominant form that can be found in nature and food.~      Inositol has been mainly used as a supplement in treating several pathologies such as~     polycystic ovary syndrome (PCOS), metabolic syndrome, type 2 diabetes mellitus (T2DM) and~     gestational diabetes (GDM). In the case of GDM, a condition defined as a glucose impairment~     first detected in pregnancy, a preventive role of inositol for GDM onset was recognized. In~     addition, inositol has been studied as a therapeutic option for the treatment of GDM and~     T2DM. The main effect of inositol is decreasing the level of insulin resistance.~     Consequently, a potential role of inositol as a treatment option could be hypothesized for~     other conditions typically characterized by insulin resistance like metabolic syndrome and~     obesity.~      Zinc also plays an important role in insulin action and carbohydrate metabolism. It may also~     have a protective role in the prevention of atherogenesis. Several human studies have~     demonstrated that Zinc supplementation reduces total cholesterol, LDL cholesterol and~     triglycerides, in addition to increasing the HDL cholesterol levels. Studies have shown that~     diabetes is accompanied by hypozincemia and high levels of Zinc in urine. In addition Zinc is~     also an integral part of key anti-oxidant enzymes and Zinc deficiency impairs their~     synthesis, resulting in increased oxidative stress.~      A supplementation with Myo-Inositol and Zinc could represent a valid strategy in paediatric~     obesity in addiction to a standard approach. The purpose of our study is to evaluate the~     supplementation of Myo-inositol and Zinc in the treatment of paediatric obesity.~   "
21639|NCT03283800|"~     Venous disease has an adverse impact on the quality of life of patients and the NHS spends~     considerable resources on this chronic condition. Copper has been shown to promote new blood~     vessel formation and therefore improve blood supply to the affected area and possibly skin~     conditions. Copper has also been shown to have strong antimicrobial properties. We plan to~     perform a study whereby patients who would normally be given leg stockings will be asked to~     wear similar stockings except that one of the stockings will contain copper fibers. Neither~     the patient nor the clinician will know which is which. Photographs of the leg conditions~     will be taken at baseline, 2, 4 and 8 weeks to evaluate healing. Benefit will be evaluated by~     a symptom questionnaire, severity scoring tools and healing scores taken from the serial~     photographs.~   "
21640|NCT03283787|"~     The purpose of this study is to evaluate incidence of complete epithelialization in stage 3 &~     4 pressure ulcers using ACell products.~   "
21641|NCT03283774|"~     Main Objective: To identify changes in metabolic control of type 2 diabetes in patients of~     the Catalan national health system during 2007-2013.~      Study design: Follow-up of a population with type 2 diabetes during 7 years (2007-2013).~      Study participants: Approximately 300,000 people with a clinical record in the SIDIAP~     database.~      Source: SIDIAP database. Variables and measurements: Age, gender, time since diagnosis of~     type 2 diabetes, associated cardiovascular risk factors, micro- and macrovascular~     complications of diabetes, causes of mortality, treatment for hyperglycaemia and for~     modifiable risk factors, other conditions related to diabetes and its management. The~     economic costs of diabetes during the study period will also be analyzed.~      Analysis: The clinical variables will be described and 95% confidence intervals will be~     calculated for the main variables associated with the study outcomes. Missing values will~     count as non-existing data and missing value imputation will not be used in the analysis. If~     a subgroup of patients is considered of particular interest, sub analyses will be carried~     out. Predictive variables of good metabolic control and of complications and mortality of~     diabetes will be analyzed with the hazard ratios for each factor.~      Results:~      Applicability: The results related to control of diabetes will serve as a basis for improving~     metabolic control and decreasing chronic complications and to optimize cost-effectiveness of~     treatments.~      Significance: A long-term study of a population receiving usual treatment is required to~     understand the changes in indicators of metabolic control, morbidity and mortality and in the~     management of the disease.~      Limitations: Those associated with the use of large population databases.~   "
21642|NCT03283761|"~     This is an open label, single-arm phase II, multi-institutional trial to evaluate the~     efficacy and safety of the combination of nab-paclitaxel and FOLFOX (FOLFOX-A) as first line~     therapy for patients diagnosed with histologically-confirmed advanced gastric/GEJ~     adenocarcinoma.~   "
21643|NCT03283748|"~     This study aims to collect the motor movement data using sensors to detect Generalized Tonic~     Clonic Seizures . Wearable sensors similar to smart watches will be used to detect seizures.~     The proposed system will consist of 3-4 wearable wireless sensor worn on the hands and legs.~     The data from these sensors will be send to the clod and collected to a central hub for~     analysis and detection of GTC Seizures.~   "
21646|NCT03283709|"~     The purpose of this study is to investigate the use of an all-ceramic dental crown material~     to restore the abutment teeth of partially-edentulous patients who need removable partial~     dentures (RPD). The outcomes of the treatment group (all-ceramic crowns) will be compared to~     a similarly-treated control group whose RPD abutment teeth are restored using conventional~     metal and metal-ceramic crowns. Primary outcomes of interest include crown survival, abutment~     tooth survival and RPD survival.The null hypothesis is that at the conclusion of the study~     there will be no differences in outcomes between the two groups.~      All dental treatment, including dental hygiene and periodontal care, fillings, crowns and RPD~     fabrication will be provided by predoctoral dental students in the University of Kentucky~     College of Dentistry student clinics. Students treating the subjects will be supervised by~     licensed, technique-calibrated faculty specialists. Following the completion of dental~     treatment, enrolled subjects will be clinically re-evaluated by investigators at 6 months,~     and at annual intervals thereafter for 5 years following RPD delivery.~   "
21647|NCT03283696|"~     The purpose of this study is to evaluate the safety of ifosfamide when added to the~     combination regimen of olaratumab and doxorubicin in participants with advanced or metastatic~     soft tissue sarcoma (STS).~   "
21648|NCT03283683|"~     This study evaluates the use of actigraphy-derived measures to improve prognostication in~     patients with advanced cancer.~   "
21649|NCT03283670|"~     Most clinical major depression responds to standard treatments (medication and~     psychotherapy); however, a significant subset of depressed patients (15-20%) do not respond~     to these treatments and are referred to as treatment-resistant major depression (TRMD). New~     treatments for TRMD are needed, and one promising line of research are drugs known as~     N-methyl-D-aspartate (NMDA) glutamate receptor antagonists. In a recent pilot study, our~     group demonstrated that the NMDA antagonist nitrous oxide is effective in TRMD.~      The purpose of the study aims to determine whether different concentrations of nitrous oxide~     (N2O) have different antidepressant effects for adults with treatment-resistant major~     depression.~      All patients will receive 3 randomized, one hour nitrous oxide inhalations to placebo (0%~     N2O), low dose (25% N2O), and high dose (50% N2O). Inhalation sessions will be at least 4~     weeks apart. Mood will be assessed at baseline, 2 and 24 hours, and 1, 2, and 4 weeks~     post-inhalation for each dose.~   "
21650|NCT03283657|"~     A large body of research has demonstrated that intensive lifestyle interventions and~     metformin are effective treatments to prevent or delay diabetes among high-risk adults, yet~     neither treatment is routinely used in practice. This pilot study will develop and evaluate~     the Diabetes Risk Education and Communication Trial (DiRECT) intervention, which communicates~     information about diabetes risk and treatment options for preventing diabetes among primary~     care patients with prediabetes. Given that 38% of U.S. adults have prediabetes, this project~     has large potential to impact public health by developing a scalable intervention to promote~     the use of evidence-based treatments that lower diabetes risk in this population.~   "
21651|NCT03283644|"~     This study investigates the chronic long-term health condition of obesity and its effect on~     neutrophil function and the inflammatory response~   "
21652|NCT03283631|"~     Malignant primary brain tumors account for more human deaths than melanoma or cancer of the~     bladder or kidney. The non-specific nature of conventional therapy for brain tumors often~     results in incapacitating damage to surrounding normal brain and systemic tissue. Thus, in~     order to reduce off-site effects and be more effective, therapeutic strategies will have to~     target tumor cells precisely while minimizing collateral damage to the neighboring cerebral~     cortex. The goal of this protocol is to transfer autologous peripheral blood mononuclear~     cells (PBMCs) transduced with genes encoding a chimeric antigen receptor (CAR) that~     recognizes epidermal growth factor receptor variant III (EGFRvIII) tumor-specific antigen~     into patients with recurrent glioblastoma multiforme (GBM) following stereotactic~     radiosurgery (SRS). The CAR used will be targeted to a tumor-specific mutation of the~     epidermal growth factor receptor, EGFRvIII, which is expressed on a subset of patients.~     Normal PBMCs derived from patients with GBM will be genetically engineered with a viral~     vector encoding the CAR and infused directly into the patient's tumor with the aim of~     mediating regression of their tumors. Despite our CAR being targeted to a tumor specific~     antigen, given the prior toxicity using CARs that were not targeted to tumor-specific~     antigens, the investigators have elected to begin with very low doses of cells.~   "
21653|NCT03283618|"~     As the prevalence and associated healthcare costs of obesity continue to increase, the need~     for obesity treatments that contribute to weight loss maintenance are needed. Through the~     functionality of a smart device, telehealth can provide quality healthcare to individuals of~     different socioeconomic communities, expand healthcare access, as well as reduce overall~     healthcare costs. This research program will uncover the effects of a 12-week commercially~     available telehealth-based weight management program (inHealth Medical Services, Inc.) on~     body weight, blood pressure, and steps.~   "
21654|NCT03283605|"~     Immunotherapy targeting the PD-1/PD-L1 pathway had previously been shown to be efficacious in~     the treatment of patients with metastatic head and neck squamous cell carcinomas.~     Stereotactic Body Radiotherapy (SBRT) to metastatic lesions causes localized cancer cell~     killing and the release of cancer cell debris, which could stimulate the immune system in the~     presence of immunotherapy. The purpose of this study is to assess the tolerability and~     efficacy of combining Durvalumab (MEDI4736), Tremelimumab and SBRT in controlling cancer~     progression. SBRT will be administered to patients while they are receiving Durvalumab and~     Tremelimumab.~   "
21655|NCT03283592|"~     This randomized controlled trial will assess the interpretability of the rank-heat plot for~     presenting the results of network meta-analysis in comparison to SUCRA (surface under the~     cumulative ranking) plots which are suggested to present one of the best ranking statistics.~   "
21656|NCT03283579|"~     This study aimed to evaluate the longitudinal association between n-6:n-3 LCPUFAs ratio in~     cord blood and child ADHD symptoms at 4 and 7 years old. This study was based on the INMA~     project, a population-based birth cohort in Spain. Higher cord blood n-6:n-3 ratio was~     associated with higher subclinical ADHD symptoms during early and mid-childhood.~   "
21703|NCT03282955|"~     The aim of the trial is to investigate safety and tolerability of an Omega-3-FA-enriched~     lipid emulsion in adult patients with chronic intestinal failure in need of long-term HPN. It~     is aimed to show non-inferiority of the lipid emulsion Lipidem (investigational test product)~     in comparison to the lipid emulsion Lipofundin MCT (investigational reference product) with~     regard to liver function.~   "
21657|NCT03283566|"~     This will be a pilot, 12-month phase II, open label, randomized, two-arm, single-blinded,~     placebo-controlled, parallel clinical trial of individuals undergoing TPAIT (Total~     Pancreatectomy and Autologous Islet Transplantation) for treatment of chronic pancreatitis~     (CP). The two study arms consist of HCQ-treated (Hydroxychloroquine) and placebo-treated~     individuals. The purpose of this study is to investigate the effects of HCQ administration~     compared to placebo on islet cell function post-autologous transplantation.~   "
21658|NCT03283553|"~     This study evaluates a multi-component communication intervention in the outpatient setting~     to strengthen communication among women being actively treated for breast cancer and their~     support network of family members and friends. The intervention comprises: 1.) a~     patient-family agenda-setting checklist completed immediately before a regularly scheduled~     oncology visit, 2.) facilitated registration for the patient portal (for patient and family~     member, as desired by the patient), and 3.) education (as relevant) on access to doctor's~     electronic visit notes. The study team will conduct a two-group randomized trial to examine~     feasibility of the protocol and to compare quality of communication with oncology providers,~     understanding of patient's cancer, confidence in managing patient's care and satisfaction~     with cancer care between patient-companion dyads who are in the intervention group (n=35) and~     patient-companion dyads who receive usual medical oncology care (n=35).~   "
21659|NCT03283540|"~     Low Anterior Resection (LAR) surgery can be done using various techniques. The traditional~     technique for performing the surgery is through one or multiple incision(s) in the muscular~     wall of the abdomen. This will allow the surgeon to gain access to inside the belly~     (Abdominal cavity). The surgeon will start from above and go down until reaching the rectum~     located low in the pelvis. The surgeon will then cut out the rectum along with some of the~     tissue surrounding it and reconnect the bowel.~      An alternative new approach to perform Low Anterior Resection is called the Trans-anal~     approach. In this technique, a tube containing special surgical tools is introduced through~     the anus (back passage), while the patient is asleep. These tools are used to free the rectum~     up from its surroundings so that it can be removed.~      Taking out the rectum via the opening of the anus (Trans-anal) is a relatively new surgical~     approach. This new technique enables the surgeon to better see deep in the pelvis which makes~     it easier to remove the rectum and its surrounding outer tissues while protecting other~     important nerves and organs located in the pelvis. However, it also involves inserting a tube~     through the opening of the anus to perform the rectal dissection. The alternative traditional~     way of doing the operation does not involve inserting such a tube because the access to the~     pelvis and rectum is gained from above through incision(s) in the abdominal wall.~      The anal sphincter is the medical name for the muscle layers surrounding the opening of the~     anus. The anal sphincter functions as a seal that can be opened to discharge body waste and~     allow the passage of stool. A damage to the anal sphincter can result in inability to fully~     control bowel movements, causing stool (feces) to leak unexpectedly. Because the Trans-anal~     approach involves inserting a tube through the opening of the anus for the duration of the~     surgery, this can lead to a certain degree of stretch and damage to the anal sphincter~     muscles.~      The main aim of this study is to compare the effect of the these two possible approaches to~     perform Low Anterior Resection operation on the muscles of the anal sphincter and whether~     they are associated with stool seepage from the anus after the operation.~   "
21660|NCT03283527|"~     Rationale: Current standard treatment of localized esophageal cancer (EC) with neoadjuvant~     chemoradiotherapy (nCRT) followed by esophagectomy with curative intent results in 30%~     complete, 40-60% partial and 20% no-response at pathologic examination. Clinical response of~     nCRT is usually evaluated with PET-CT. However, response measurements are currently still~     insufficient in optimizing EC treatment. Proper pre-surgical response prediction may allow~     individualized treatment with esophagus-preservation in complete responders or switching to~     an alternative treatment in non-responders. Interestingly, in many tumors, a subset of cells~     has been found to possess cancer stem cell (CSC) properties with associated signaling as~     drivers of tumor (re-)growth and therapy resistance. Response of CSC-derived tissue~     resembling in vitro cultured tumor organoids may reflect patient's tumors sensitivity to~     therapy.~      Objective: To create a patient derived organoid model for EC patients to predict the~     pathologic tumor response to nCRT in clinical practice. This will allow a more personalized~     approach in future treatment of locally advanced EC.~      Study design: Fresh esophageal tumor material will be collected during diagnostic endoscopic~     ultrasound (EUS) in participating patients. These biopsies will be used to select cancer stem~     cells, which will be cultured to derive organoids (esophageal cancer patient derived~     organoids; EC-PDO). When the EC-PDO contain sufficient cells, these cells will be treated~     with radiotherapy and/or chemotherapy in order to obtain dose-response curves. The response~     of these EC-PDOs will be compared to the actual tumor response to nCRT treatment in these EC~     patients, which will be assessed at the definitive pathologic examination of the resection~     specimen after esophagectomy with curative intent.~      Study population: All patients with curatively treatable and resectable esophageal cancer~     (adenocarcinoma or squamous cell carcinoma) can be included in this trial.~      Main study parameters/endpoints: The main endpoint is response prediction to~     chemoradiotherapy by EC-PDO; the steepness of the dose response survival curve in the~     organoids in relation to the pathologic response after resection in the clinical situation.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: The patients will be asked to undergo 3 to 6 additional biopsies during~     endoscopic ultrasonography (EUS) for the TNM staging of the tumor. The risk of these~     additional biopsies is not greater than the biopsies for the diagnosis of EC. The patient~     will not benefit from participation in this trial.~      For the future approach we can get more insight into the mechanism of (chemo)radiation~     response or resistance to nCRT, which might lead to a better patient selection and more~     individualized esophageal cancer treatment in the future. This improvement in selection and~     treatment can result in less over or under-treatment of these EC patients.~   "
21661|NCT03283514|"~     Esthetic is a major factor in complete denture (CD) success. Patient involvement in esthetic~     project plays a crucial role in denture acceptance and patient satisfaction. Historically,~     teeth choice and arrangement were made according to Frush and Ficher's recommendations~     focusing on natural looking of esthetics. Dentists may also propose to restore the dentate~     state looking for denture when preextraction data are available. Recently, a patient-centered~     approach based on attractivity has been proposed and may lead to in an appearance~     transcending the laws of nature.~      The aim of the present study was to investigate actual denture esthetic expectations in a~     French edentate population followed in a university dental clinic (Rothschild Hospital ,~     AP-HP).~   "
21662|NCT03283501|"~     Evaluate incidence, clinical indications, and feasibility of PCI performed after TAVI.~   "
21663|NCT03283488|"~     Cancer-associated anorexia-cachexia is an insidious syndrome that has a major impact on the~     patient's quality of life, but is also associated with a significant reduction in survival.~     Despite its clinical importance, it remains a widely underestimated and untreated condition.~     Considering the scarcity of pharmacological measures, it is necessary to invest in studies~     that may contribute to the rational and effective treatment of this clinical condition.~     Mirtazapine has a special therapeutic potential because it is a well-tolerated drug with few~     adverse effects and with well-known orexigenic action in clinical practice.The objective of~     this study is to evaluate the effect of mirtazapine as a pharmacological measure in the~     management of cancer-related anorexia-cachexia in patients in palliative care. A randomized,~     double-blind clinical trial involving 52 cancer patients with anorexia-cachexia in palliative~     care will be conducted. Patients will be randomized to receive mirtazapine or megestrol and~     will be evaluated longitudinally for a period of 8 weeks. The primary endpoint will be to~     assess the effect of mirtazapine on anorexia and weight gain and secondary outcomes will be~     to assess the tolerability and safety of mirtazapine and the effect of mirtazapine on body~     composition, quality of life, and functional capacity of patients.~   "
21734|NCT03282552|"~     High flow oxygen therapy has been applied after extubation in cardiac surgery patients with~     uncertain efficacy. The current authors plan to conduct a prospective, randomized, controlled~     study of nasal high flow therapy (NHF) application with high (60L/min) or low flow (40L/min)~     oxygen mixture administration versus standard oxygen treatment (Venturi mask) after~     extubation of patients undergoing elective or non-elective cardiac surgery.~   "
21664|NCT03283475|"~     The sample will be divided into two groups:- - Control group which will include 60 adult~     individuals between 18 and 35 years old who have BMI between 19 and 25, not complaining of~     any thigh contour deformities or skin redundancy with no history of body weight fluctuations.~     This group will be divided into two subgroups, 30 males and 30 females.~      The following measurements will be recorded :- Weight, height, thigh length, hip~     circumference, maximum buttocks circumference, upper thigh, middle thigh and lower thigh~     circumferences.~      - Patient group which will include 40 patients suffering from thigh lipodystrophy and contour~     deformities who will undergo surgical intervention after their assessment.~      After assessment, one of the following techniques will be selected:-~        -  Liposuction only.~        -  thigh lift.~        -  Liposuction assisted thigh lift.~   "
21665|NCT03283462|"~     This is a randomized, double-blind, single-center, placebo-controlled Phase 2 trial enrolling~     60 healthy elderly subjects (30 placebo and 30 AMAZ-02 administration) who are ≥65 and ≤ 90~     years of age with evidence of low mitochondrial function. AMAZ-02 or placebo will be orally~     administered for 4 months.~   "
21666|NCT03283449|"~     The goal of this study is to demonstrate the feasibility of mapping tau pathology in subjects~     with Primary Progressive Aphasia, using PET protocol with F-AV-1451 (trade name AV-1451) and~     to systematically document the extent and location of tau pathology in PPA patients in vivo~     using the same techniques.~   "
21667|NCT03283436|"~     The goal of this study is to assess the efficacy of a superior hypogastric plexus block~     (SHPB) for pain relief following a laparoscopic hysterectomy.~   "
21668|NCT03283423|"~     To perform image-guided laparoscopic intra-abdominal lymph node biopsy with goal of~     minimizing surgical risk and improving accuracy of biopsy.~   "
21669|NCT03283410|"~     Propofol's dose-response curve is know for the average adult but propofol's plasmatic~     concentration under total intravenous anesthesia differences between young and elderly must~     be modeled. Adaptative clinical trial (Dixon's Up and Down) for determination of ED95% of~     propofol concentration for hypnosis under general anesthesia for young and elderly adults.~   "
21670|NCT03283397|"~     Multiple sclerosis is a chronic autoimmune, inflammatory neurological disease of the central~     nervous system. It is the most common disabling neurologic disease of young people. This~     study is planned for the evaluation of efficacy, safety and tolerability of neuropeptide~     combination of metenkefalin and tridecactide (EK-12) as compared to INF beta-1a (REBIF®) in~     patients with RRMS. The primary objective of this study is to prove the superiority of~     efficacy of neuropeptide combination of metenkefalin and tridecactide (EK-12) compared to INF~     beta-1a (REBIF®) in patients with RRMS on the basis of annualized protocol defined relapse~     rate by 144 weeks.~   "
21671|NCT03283384|"~     The aim of this prospective, randomized, multicenter, open-label, phase II study is to test~     if chemotherapy can be replaced by the combination of ribociclib plus letrozole as a~     neo-adjuvant therapy for patients with non-metastatic primary luminal breast cancer.~   "
21672|NCT03283371|"~     The primary efficacy objective of the study is to determine if adjunctive therapy of~     natalizumab 300 mg intravenous (IV) every 4 weeks reduces the frequency of seizures in adult~     participants with drug-resistant focal epilepsy. The secondary efficacy objective is to~     assess the effects of natalizumab versus placebo in drug-resistant focal epilepsy on~     additional measures of seizure frequency.~   "
21673|NCT03283358|"~     The overall aim of the study is to evaluate a nurse-led intervention (person-centered follow~     up and health promotion) program in comparison to standard follow up for patients treated~     with surgical or endovascular revascularization of Intermittent Claudication.~   "
21674|NCT03283345|"~     It is aimed to evaluate pathophysiology of systemic responses to trauma via using interleukin~     (IL) -1 and IL-6 levels and determining timing of surgery through phases of menstrual cycle.~   "
21675|NCT03283332|"~     Black and ethnic minority groups living in the UK experience high rates of chronic diseases~     such as diabetes, hypertension and heart disease, general morbidity and poor mental health.~     The cause of these excess rates is unknown but obesity, smoking, diet and deprivation are~     important contributing factors. There is also global evidence of the association of these~     diseases in adulthood with health and deprivation in early life and childhood. Persisting~     social deprivation over the lifecourse is disproportionately borne by some ethnic minorities~     (Harding and Balarajan 2001) but the impact on the health of their children is virtually~     unknown. Least is known about the health of Black Caribbean young people. It is important to~     examine risk factor differences by social predictors within the ethnic minority groups as~     well as between them. The DASH Study started as a school-based cohort study of adolescents~     from the main ethnic groups (White British, Black Caribbean, Black African, Indian, Pakistani~     and Bangladeshi) in 10 London boroughs. Wave 1 took place in 2002/03 (MREC Ref:~     MREC/2/10/12), when participants were aged 11-13 years (school years 7 and 8). Wave 2 took~     place in 2005/06 (MREC Ref: 05/MRE10/43) when they were 14-16 years (school years 9 and 10).~     Wave 3 took place in 2010/2011, when participants were aged 19-21 years and involved a postal~     follow-up complemented by telephone interview and on-line questionnaires. The current~     proposal is for a feasibility study, using a small sample of the DASH cohort, to inform the~     design of the next full face-to-face follow-up. DASH will be the first large scale UK~     longitudinal cohort of ethnic minority youths with both social and biological measures from~     childhood to early adulthood. It will allow detailed examination of ethnic differences in the~     social patterning of biological mechanisms and pre-clinical disease in young adulthood.~   "
21676|NCT03283319|"~     The main purpose of this study is to assess the safety and ability of a Panblok H7 influenza~     vaccine adjuvanted with AS03 or MF59 to generate an immune response after 2 doses separated~     by 28 days. Three different antigen dose levels of Panblok H7 will be tested.~   "
21677|NCT03283306|"~     Contrast-enhanced ultrasound(CEUS) of carotid artery plaque is a novel method that enabled~     direct visualization of neovessels in the vulnerable plaque. Plaque enhancement with CEUS~     showed correlation with the histologic density of neovessels within the carotid plaque and~     the previous cardiovascular events. Vulnerable plaques with a high risk of thromboembolic~     complications and rapid progression is associated with acute ischemic stroke. The prognostic~     value of vulnerable carotid artery plaque depicted with CEUS has not been fully investigated.~     The purpose of this study is to define prognostic value of plaque enhancement on carotid CEUS~     in acute stroke patients. Research question is; in acute ischemic stroke patients with~     ipsilateral carotid plaque as probable etiology of stroke, is the presence of carotid plaque~     enhancement on CEUS independent predictor of future stroke.~   "
21735|NCT03282539|"~     The study evaluates the security of LAMS with ando without a coaxial double pigtail plastic~     stent in the management of pancreatic fuid collections.~   "
26966|NCT03214016|"~     This study evaluates the effects of Pilates method and aerobic training in hypertensive~     subjects. Half of participants will be trained with Pilates, while the other half will be~     trained with aerobic exercise during 8 weeks.~   "
21678|NCT03283293|"~     The gross tumor volumes of the primary site and the neck nodes (GTVnx and GTVnd) could be~     delineated according to the post-NACT tumor position and receive radical radiation dose,~     while the tumor disappear after NACT could be encompassed in the first clinical target volume~     (CTV1) and receive high preventive radiation dose. Through this method,it is more likely to~     achieve the ultimate goal that maximize the chance of cure while minimize the injury of~     surrounding normal tissues, maintaining organ function and life quality. Therefore, this~     stage II clinical trial was designed to study the prognosis and locoregional failure patterns~     of this target volume delineation method in LA-NPC treated with NACT plus CCRT.~   "
21679|NCT03283280|"~     clinical performance of short fiber reinforced resin composite versus indirect nanohybrid~     resin composite onlay restorations in complex proximal cavities of molar teeth will be~     evaluated over one year.~   "
21680|NCT03283267|"~     This is a single center, inpatient, open label pharmacodynamic study to determine the effect~     of 5 g and 10 g doses of Sodium Zirconium Cyclosilicate (ZS) administered once daily (qd) for~     4 days on potassium and sodium excretion in healthy Chinese subjects on a standardized, low~     sodium and high potassium diet.~   "
21681|NCT03283254|"~     The primary aim of this study is to determine if a behavioral intervention targeting maternal~     caregiving of young infants can increase infant sleep and reduce fuss/cry behavior, and~     thereby (1) reduce the incidence and/or severity of postpartum maternal depression and (2)~     improve the quality of the mother-infant interaction and subsequent child development.~     Specifically, the study team will investigate: (1) the effectiveness of the intervention~     compared to usual care; (2) if the effects of the intervention can be detected in the~     assessments of the quality of mother-infant interaction; (3) if there are prenatal and/or~     postnatal biomarkers that can help identify infants whose behavior is more likely to play a~     role in their mothers' depression; (4) if these markers differentiate which infants will be~     most responsive to the intervention(s); and (5), if assessments of brain function at birth~     and at 4-6 weeks of age provide biological nodal points for identifying the effects of the~     intervention on infant brain development. Participants will be recruited during their 2nd~     trimester, and will be randomly separated into one of two groups: a group that receives~     coaching in parenting techniques (4 in-person coaching sessions and 1 phone session) or one~     that receives treatment as usual.~   "
21682|NCT03283241|"~     A randomised, multicentre, double blind, parallel group comparative investigation where~     subjects will be randomised to receive coated or uncoated implants~   "
21683|NCT03283228|"~     1. Detect the expression of marker CD56 and CD11b in newly diagnosed cases of adult AML.~        2. Study correlation between CD56 and CD11b expression with haematological parameters in~          cases of adult AML.~   "
21684|NCT03283215|"~     to research in the different causes of failure to thrive in children including organic and~     non organic causes~   "
21685|NCT03283202|"~     This is Phase 1/2 study of CC-122 in combination with rituximab, cyclophosphamide,~     doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy, for first-line treatment of~     patients with Diffuse B-Cell Large B-Cell Lymphoma (DLBCL) that has poor risk factors.~     Approximately 40% of patients diagnosed with DLBCL are not cured with R-CHOP alone and would~     need additional treatment for DLBCL in the future. The addition of the experimental drug~     CC-122 with R-CHOP could help in controlling DLBCL in this patient population.~   "
21686|NCT03283189|"~     The use of cosmetics is an important source of exposure to many chemicals including endocrine~     disruptors. Recently, national and international scientific recommendations have been issued~     to limit exposure to chemicals during pregnancy. However, the perception and the use of~     cosmetics by pregnant women is still little studied. The objectives of the PERICOS study are~     to identify the risk perception and the attitudes regarding cosmetic's use by the pregnant~     women.~      Understanding the risk perception, the knowledge, attitudes and expectations of women about~     the use of cosmetics during pregnancy will help to set up effective strategies to improve~     prevention of chemical exposure.~   "
21687|NCT03283176|"~     Use of Ribavirin could affect hematologic profile of the patients negatively. With advent of~     new antiviral therapy, the preexisting hematologic changes may alter or corrected after~     treatment. However, this point is still not properly studied.~   "
21688|NCT03283163|"~     The wars in Iraq and Afghanistan are creating a new generation of Veterans, including an~     increasing number of women Veterans, who present with comorbid PTSD and chronic pain~     conditions from recent deployment-related physical injuries and exposure to psychological~     trauma. Health behavior change has become increasingly important in treating these conditions~     and proactively preventing long-term negative health sequelae, in order to benefit these~     Veterans directly and reduce the growing challenges to our healthcare system. The proposed~     CDA-2 program of research will use an innovative translational research approach to study~     whether a chronic progressive -based exercise program will reduce chronic pain in patients~     with PTSD and to elucidate and modify potential PTSD-related deficiencies in neurobiological~     and psychological responses to exercise to optimize the physical and psychological benefits~     of exercise for these individuals.~   "
21689|NCT03283150|"~     Deep brain stimulation (DBS) of different brain nuclei is a treatment for multiple brain~     disorders. The subthalamic nucleus (STN) and globus pallidus have been used to treat advanced~     Parkinson's disease for a long time. The ventral intermediate nucleus of the thalamus is an~     effective target for treating essential tremor patients. STN and the internal segment of the~     globus pallidus are useful targets for treating dystonia.~      To achieve this optimal electrode localization, many centers perform electrophysiological~     mapping of the target nuclei using microelectrode recording (MER). This way they can achieve~     precise localization of the electrode. During the mapping procedure, microelectrodes are~     passed through the target nuclei, and the electrical neuronal activity is observed and~     recorded. The surgical team can identify the precise location of the target nuclei and its~     borders according to the typical activity of its neurons.~      This study will compare the activity of neurons in several DBS targets before, during and~     after sedation with propofol, remifentanil and dexmedetomidine. The goal is to understand the~     effects of anesthetics on the neuronal activity in these targets, allowing us to choose the~     most appropriate sedation protocol to use during implantation of DBS electrodes in deep brain~     structures (bearing in mind that each structure may have a different optimal protocol).~   "
21690|NCT03283137|"~     This study will be a standard 3+3 design with a lead in of TGR-1202 at dose of 600mg (dose~     level 1) or 800mg daily (dose level 2) for 6 weeks, i.e. 2 cycles, followed by pembrolizumab~     at 200mg every 3 weeks for 8 cycles along with TGR-1202 for patients with relapsed/refractory~     B-cell NHL or CLL. If the dose of 600mg daily of TGR-1202 (dose level 1) is tolerated in the~     first cohort the dose will be increased to 800mg qd which is the only and final dose~     escalation. If TGR-1202 is not tolerated at 600mg daily the dose will be decreased to 400mg~     daily. The lead in of TGR-1202 was chosen to ensure clinical benefit and to minimize the~     occurrence of early overlapping toxicity with pembrolizumab as most toxicities were observed~     early on in the treatment with idelalisib, a related PI3K-inhibitor, and rituximab.~   "
21691|NCT03283124|"~     Pelvic organ prolapse(POP) is a common health problem and has significant negative effects on~     woman's quality of life. Transvaginal mesh procedure is a durable reconstructive surgery, but~     the mesh kits are expensive for underdeveloped countries. Our preliminary trial showed that~     the use of self-tailored mesh had good success rate (91.8% at 1-year follow-up) and low~     complication rate. The trial is designed to compare self-tailored titanium-coated~     polypropylene mesh procedure with mesh-kit in the treatment of POP stage III-IV in terms of~     efficacy, safety and cost-effective .~   "
21692|NCT03283111|"~     This is a retrospective, single-center, non-randomized, non-controlled study. This study aims~     to explore the effect of T-lymphocyte subsets changes in immunologic reconstitution and~     prognosis in lymphoma patients who were treated by autologous stem cell transplantation.~   "
21693|NCT03283098|"~     This is a multiple dose, double-blind, randomized, placebo-controlled clinical study~     conducted in Chinese subjects residing in Mainland China with chronic kidney disease~     receiving hemodialysis. The treatment duration will be approximately 4 weeks with a post~     treatment followup of 4 weeks. A dose will be given at each scheduled hemodialysis session~     (Dose administered three times a week for 4 weeks, for a total of 12 doses).~   "
21694|NCT03283085|"~     The purpose of this study is to evaluate the safety and tolerability of long-term treatment~     with SHP647 in participants with moderate to severe Ulcerative Colitis (UC) or Crohn's~     disease (CD).~   "
21695|NCT03283072|"~     Exposure to acute intermittent hypoxia (AIH) can facilitate of motor output but no studies of~     sensory effects has been reported.~   "
21696|NCT03283059|"~     Inhibition of acetylcholinesterase has been a effective treatment for Alzheimer's disease.~     Octohydroaminoacridine, a new acetylcholinesterase inhibitor, is a potential treatment for~     Alzheimer's disease. The investigators conducted a 26 weeks, randomized, double-blind,~     double-dummy, placebo- and positive- parallel controlled and extended single arm to 54 weeks~     multicentre phase III clinical trial to investigate the effects of octohydroaminoacridine in~     patients with mild-to-moderate Alzheimer's disease. Patients were randomized to receive~     placebo thrice daily, or octohydroaminoacridine 4 mg/TID or ARICEPT 5mg/QD.~   "
21697|NCT03283046|"~     This study has 2 parts: a Dose Escalation Part and a Dose Expansion Part.~      The goal of the Dose Escalation Part of this clinical research study is to find the highest~     tolerable dose of nivolumab in combination with ipilimumab and the standard of care~     (lenalidomide and dexamethasone) that can be given to patients with multiple myeloma (MM).~      The goal of the Dose Expansion Part of this clinical research study is to continue to study~     the safety of the highest tolerable dose found in Phase 1 of the study.~   "
21698|NCT03283033|"~     The investigators propose an efficacy study (i.e., do salad bars work under controlled~     conditions in naturalistic settings) to test whether introducing salad bars in elementary,~     middle, and high schools that have never had salad bars affects students' FV consumption and~     waste during lunch. A cluster randomized controlled trial will test new salad bars against~     controls for 6 wks, with/without an additional 4-wk marketing phase .~   "
21699|NCT03283020|"~     The purpose of the study is to evaluate the impact of different bolus volumes and viscosity~     on remifentanil-induced swallowing dysfunction in healthy volunteers.Hence, whether~     swallowing tasks can be done safer during sedation by altering bolus volumes and viscosities~     will be revealed. Furthermore, the study will clarify underlying mechanisms (central vs.~     peripheral effects) of remifentanil-induced swallowing dysfunction. If methylnaltrexone~     reverses the remifentanil-induced effects on swallowing, this would suggest a dominant~     peripherally mediated mechanism.~   "
21700|NCT03283007|"~     Lung transplantation (TxP) is now a validated treatment of end-stage pulmonary diseases, but~     long-term graft and patient survival are still hampered by the development of chronic~     allograft dysfunction (CLAD) affecting > 50% of patients.~      The investigators propose to conduct a phase III clinical randomized trial that will assess~     the efficacy of Nintedanib to hamper the lung decline in LTx recipients with BOS. This is the~     first trial testing this molecule in lung Tx recipients. If case of demonstrated~     effectiveness of Nintedanib, the benefit for lung transplant patients carrying a BO is high~     in terms of stabilization of lung function and enhancement of survival.~   "
21701|NCT03282981|"~     One in four Veterans is affected by diabetes and will develop a diabetic foot ulcer. Diabetic~     ulcers are very challenging to manage and are the most common cause of leg amputation. Many~     advanced treatments are expensive and difficult to use in the clinic or at home. Those newer~     therapies have shown little success in healing diabetic foot wounds. The investigators'~     laboratory and animal work has suggested that a safe medication, currently used as an eye~     drop for treatment of glaucoma, can heal these ulcers. The investigators are proposing to~     test this drop (timolol) directly on the surface of the foot ulcer to see if can improve~     healing faster than the current standard of care. To do this, the investigators propose a~     randomized controlled trial with two groups of patients with diabetic foot ulcers: one will~     receive standard of care with timolol while the other will receive standard of care with a~     gel (hydrogel, as placebo medicine).~   "
21702|NCT03282968|"~     The study will include 20 patients after troke, randomly assigned to the experimental and~     control group (10 each). In both groups, the program with last for five days; walking and~     balance will be assessed before and after the program. Both groups will receive regular~     neurophysiotherapy; in addition, the experimental group will exercise each day by playing~     REWIRE games, while the control group will perform standing balance exercises.~   "
22587|NCT03271333|"~     Diffuse infiltrating pneumonia (DIP) is a severe complication of systemic sclerosis and one~     of the leading cause of death in this condition. The main objective of this study is to~     prospectively describe the evolution of DIP overtime and to find prognosis factors.~   "
21704|NCT03282942|"~     Systemic arterial hypertension (SAH) is characterized by elevated and sustained blood~     pressure levels, related to several risk factors. Modifying lifestyle to combat risk factors~     associated with cardiovascular disease is critical, as such factors are related alteration of~     endothelial vasodilator response leading to progressive loss of its protective function.~     However, endothelial dysfunction related to hypertension is not only related to the decrease~     in the bioavailability of endothelium relaxants, but also to the time of presence of~     hypertension, increased production of vessel contraction factors and oxidative stress related~     to the disease. In this way, physical training presents as a non-drug strategy capable of~     directly and indirectly influencing the pathophysiology of hypertension. In this way the~     objective of the present work will be to evaluate the acute and chronic effect of aerobic~     exercise and strength on blood pressure, blood markers of vasodilation and vascular~     endothelial vasoconstriction, as well as the repercussion on flow-mediated dilatation and~     oxidative stress markers, In middle-aged hypertensive individuals before and after 12 weeks~     of training. Study hypothesis: The expected results of the research are that the endothelial~     response of biochemical markers of vasodilation and vasoconstriction will change positively~     after aerobic and strength training and the responses will be similar when compared between~     groups. There will be an improvement in the antioxidant capacity in both groups and the~     magnitude of the hypotensive effect will be greater in the aerobic group when compared to~     control and strength.~   "
21705|NCT03282929|"~     A single dose, open label, randomized cross-over study to explore the pharmacokinetics and~     pharmacodynamics of epinephrine in healthy male and female subjects~   "
21706|NCT03282916|"~     Anti-viral therapy in Alzheimer's disease will investigate the efficacy of treating patients~     with mild Alzheimer's disease with the U.S.A marketed generic anti-viral drug Valtrex~     (valacyclovir, 500mg oral tablet). Valacyclovir at 2 g to 4 g per day, repurposed to treat~     Alzheimer's disease, will be compared to matching placebo in the treatment of 130 mild AD~     patients (65 valacyclovir, 65 placebo) who test positive for herpes simplex virus-1 (HSV1) or~     HSV2. The study will be a randomized, double-blind, 18-month Phase II proof of concept trial.~   "
21707|NCT03282903|"~     The PREdiCCt Study:~      This is a major study that is now being launched. This is the first study of its kind and is~     specifically directed toward understanding how environmental factors and the gut~     microorganisms influence IBD flare and recovery. For the PREdiCCt study, the investigators~     hope to recruit 1500 people in remission from Crohn's disease or ulcerative colitis (illness~     under control) from 28 inflammatory bowel disease clinics across the UK.~      The investigators hope to conduct the study in the following stages;-~        1. Patients with Crohn's disease, ulcerative colitis or inflammatory bowel disease~          unclassified (IBDU) in clinical remission (under control) will be approached in~          gastroenterology clinics across the country and invited to take part in the PREdiCCt~          study. Alternatively they will express their interest in the study after seeing PREdiCCt~          promotional leaflets/posters/videos/social media.~        2. Participants will attend a clinic visit for routine tests and also to complete several~          questionnaires with a research nurse.~        3. At home over the next week participants will complete detailed questionnaires assessing~          their environment and diet. Participants will also collect a stool and saliva sample and~          send this to our laboratories (the investigators have developed easy ways of doing this~          reliably by post). The stool sample is to analyse the microorganisms in the~          participant's gut and the saliva is used to analyse their DNA.~        4. Investigators will then follow patients' progress over 24 months. They will be asked to~          complete a short questionnaire every month with a longer questionnaire after 12 months~          and culminating in a final questionnaire 24 months after their initial clinic visit.~        5. If a participant experiences a flare, investigators will collect an additional stool~          sample; but most importantly investigators will look to see how the environmental and~          microorganism factors recorded at the beginning differ for those that flare up versus~          those that don't.~      What investigators hope to achieve;-~        1. Finding out the environmental and dietary factors for patients to avoid because they~          trigger flare.~        2. Finding out behaviours for patients to adopt because they bring about remission.~        3. Finding out what the microorganisms that predict flare look like.~        4. Gaining information which helps future studies aimed at finding better diets for IBD~          sufferers.~        5. Developing ways of gathering information online from IBD patients about their well-being~          that doctors can routinely use.~      The investigators have assembled expert doctors, epidemiologists, microbiologists, nutrition~     scientists, and bioinformaticians. These experts will use the systems the investigators have~     put in place to make sure PREdiCCt succeeds. It will yield a lot of new information to help~     sufferers right away; but the information will also help to kick start many important future~     studies that will bring us ever closer to a cure for Crohn's disease and ulcerative colitis.~   "
21708|NCT03282890|"~     This study will evaluate the efficacy and cost-effectiveness of CHRP-BB - an integrated~     bio-behavioral approach that incorporates the use of PrEP - with an evidence-based behavioral~     approach aimed at enhancing PrEP adherence and HIV risk reduction among high risk PWUD.~   "
21709|NCT03282877|"~     In the UK, over 670,000 older people are living with dementia which has a substantial,~     multi-level impact on society, the person with dementia, and their carers. There is a need~     for an increase in the availability of psychological therapies since people with dementia can~     face difficulties with staying mentally stimulated and engaged. Cognitive Stimulation Therapy~     (CST) offers a person based approach and can help to relieve some of these problems. It is a~     brief manualised evidence based psychological treatment for people with mild to moderate~     dementia which has shown to improve cognition and quality of life. CST is currently available~     in both a group and individualised format called iCST. It is worthwhile to explore a~     computerised version of iCST since it would take together the added value of computer use and~     the beneficial effects of iCST which might produce combined, positive effects on cognition~     and quality of life. The investigators have spoken to people with dementia and their carers~     who are keen on using technology to stay mentally active and stimulated. This study sets out~     to develop and evaluate the potential benefits of an iCST web-application within a~     feasibility study. The effects on cognition and quality of life between (a) usual care and~     (b) iCST web-application over 11 weeks will be compared. A web-application is a website which~     can easily be accessed on and is compatible with computers and tablets. In order to create~     the most appropriate and practical web-application, the research team will work closely~     together with people with dementia, their carers, and the software company. An iCST~     web-application will compliment traditional CST by making it even more accessible since~     technology users will be able to access it easily on their device. Furthermore, a~     computerised version of iCST will by highly relevant for upcoming generations who have grown~     up with the use of technology.~   "
21710|NCT03282864|"~     This study uses a crossover study design to examine the impact of a two-week bedroom based~     indoor air filtration on the concentration of indoor airborne pollutants, personal exposure~     to airborne pollutants and health indicators among asthmatic children living in Shanghai,~     China~   "
21711|NCT03282851|"~     This study aims to compare the PK/PD of a single injection of investigational Medicinal~     Product (IMP) MSB11456, US licensed Actemra and EU approved RoActemra in healthy adult~     subjects.~   "
21712|NCT03282838|"~     An Open-Label, Three-Way Randomized, Single Dose Crossover Study Comparing Bioavailability of~     DFN-15 under fasting conditions versus Comparator under fed conditions and to determine~     food-effect of DFN-15 in Healthy Adult Subjects~   "
21713|NCT03282825|"~     Phase Ib clinical study of Decitabine and Paclitaxel combination therapy~   "
21736|NCT03282526|"~     -  Assess the differences between flow and volume responses after bronchodilator~          reversibility testing in patients over different clinical chronic obstructive pulmonary~          disease stages (GOLD stage I to GOLD stage IV).~        -  Study the Correlation between the bronchodilator response and the severity of the~          disease.~   "
22588|NCT03271320|"~     The primary objective is to assess the burden of aesthetic complication in systemic~     sclerosis. Systemic sclerosis is associated with changes in skin aspect which can impact the~     appearance. Aesthetic burden will be assessed through several scales and compared to a~     control group of health subjects.~   "
21714|NCT03282812|"~     This study aims to investigate diet, lifestyles, serum metabolomics in relation to breast~     cancer risk in a nested case-control study including 1,547 postmenopausal women from the~     Cancer Prevention Study II (CPS-II) Nutrition Cohort. The CPS-II Nutrition Cohort is a~     prospective cohort study of cancer incidence and mortality among 184,185 men and women,~     established by the American Cancer Society in 1992. Participants completed a~     self-administered baseline questionnaire in 1992/1993 including demographic, medical, and~     lifestyle information. Follow-up questionnaires were sent to living participants in 1997 and~     every other year to update exposure information and ascertain newly diagnosed cancers. From~     June 1998 through May 2001, blood specimens were collected from 21,963 women. All~     participants completed a short questionnaire and provided informed consent at the time of~     blood draw. Non-fasting whole blood collected from each participant was shipped chilled~     overnight to a central repository, processed, and frozen in liquid nitrogen at approximately~     -130 °C for long-term storage.~      Of the 21,963 women who provided a blood sample, investigators identified 782 postmenopausal~     women diagnosed with invasive breast cancer between blood draw date and June 2011 who had not~     been diagnosed with cancer (other than nonmelanoma skin cancer) before blood draw or prior to~     their breast cancer diagnosis. Controls were 1:1 matched to cases on date of birth, date of~     blood draw, and race and were cancer free at the date of case diagnosis. Seventeen women who~     were selected as controls were later diagnosed with breast cancer, at which time they became~     a case. A total of 1,547 postmenopausal women were included in the breast cancer nested~     case-control study.~   "
21715|NCT03282799|"~     This study will evaluate the frequency of ovulation and cervical mucus quality of~     HIV-infected women on efavirenz (EFV)-based antiretroviral therapy (ART) using either a~     single etonogestrel (ENG) implant or two ENG implants for at least one year.~   "
21716|NCT03282786|"~     Patients with inflammatory bowel disease (IBD) frequently undergo endoscopic examination and~     may suffer from diagnostic procedures. Independent from IBD patients, colonoscopy is usually~     performed using air insufflation, however recent data indicates a superior role of carbon~     dioxide (CO2) as an insufflation gas during colonoscopy. Using CO2 leads to a lower degree of~     patient's discomfort. The role of CO2 as an insufflation gas for colonoscopy in IBD patients~     remains undetermined, wherefore this study aims to address this issue.~   "
21717|NCT03282773|"~     This study will compare clinical outcomes of immediate stent implantation with deferred stent~     implantation(4-10days after primary angiography) for patients presented with acute myocardial~     infarction due to left main coronary artery occlusion.~   "
21718|NCT03282760|"~     This will be a phase I, open, multicenter, international study performed by 3 participating~     centres across two countries (Italy and Switzerland). Fifteen to 24 patients affected by SPMS~     will be enrolled, according to a standard phase I design over 18 months. All patients will~     enter a 3 months run in phase. Thereafter they will receive one of four different doses of~     allogenic hNSCs (dose A=5 millions hNSCs; dose B=10 millions hNSCs; dose C=16 millions hNSCs;~     dose D=24 millions hNSCs). Following hNSCs injection, all SPMS patients will receive~     immunosuppression with tacrolimus for 6 months. Patients will be clinically followed monthly~     for 1 year and then every 6 months for the 5 years following the study completion (possibly~     all life long).~      MRI assessments will be performed monthly for the first 6 months and then every 3 months for~     5 years following the study completion.~   "
21719|NCT03282747|"~     Venous thromboembolism occurs with an incidence of about 1 per 1000 per year in adults . The~     main consequences are death, recurrence, post-thrombotic syndrome and major bleeding due to~     anticoagulation. Mortality rates are lower among patients with idiopathic venous thrombosis~     and higher among those in whom thrombosis occurs in the presence of cancer.~      The risk increases with the age for unclear reasons. There are also differences in the~     incidence according to ethnicity; however, data in subjects of European ancestry are scarce.~      Several studies have documented an association between thrombosis and ABO group.~     Specifically, non-O blood groups have a higher risk of myocardial infarction, angina,~     peripheral vascular disease, cerebral ischemia and venous thromboembolism than O. While there~     are numerous studies carried out in patients who have already shown thromboembolic events,~     data on the incidence of risk factors in the healthy population are completely inadequate.~      Understanding the risk factors for venous thrombosis is necessary to maximize the prevention~     of this disease in individuals and groups of high-risk patients . For this purpose a~     self-administered questionnaire will be used. Data obtained by blood donors on exposure to~     risk factors will be used to set up a clinical score to validate in future studies to carry~     out in patients with VTE.~   "
21720|NCT03282734|"~     A lot of patients suffer the balance and gait disorders after stroke. Many rehabilitation~     therapies have been provided to improve the balance and gait function in stroke patients.~     However, most rehabilitation therapies are performed in only hospitals, in spite of the~     difficulty of moving from home to hospitals for stroke patients. Home-based smart~     rehabilitation system (Uincare®, D-gate Co.) can provide the specific rehabilitation training~     program to stroke patients in their home. This study aims to investigate the effects of the~     home-based exercise program with smart rehabilitation system on balance and gait functions in~     stroke patients.~   "
21721|NCT03282721|"~     To compare the effect of redesigned transverse facial cleft treatment and traditional~     transverse facial cleft treatment.~   "
21722|NCT03282708|"~     The SHAPES-Captivity study seeks to identify metagenomic components of the intestinal~     microbiome shared by human beings and captive great apes living in proximity and in direct,~     daily contact. The investigators will determine the phylogenetic diversity of enterotypes~     (bacterial and viral) shared between human beings and great apes and will link these results~     with participant-observations of caretakers' activities (and contacts) with these great apes.~   "
21723|NCT03282695|"~     The main objective of this study is to estimate the cost-effectiveness of ozone therapy in~     patients on the waiting list for surgery due to disc herniation.~   "
21737|NCT03282513|"~     Study AG120-C-012 is a Phase 1, open-label, single-dose study designed to evaluate the PK,~     safety, and tolerability of a single 500 mg AG-120 (Ivosidenib) dose in subjects with mild or~     moderate hepatic impairment (HI) compared to subjects with normal hepatic function. The study~     will be conducted at 2 US centers.~   "
28668|NCT03191747|"~     Examining whether men with greater Avoidance to Femininity subscores using the Male Role~     Norms Inventory - Short Form will demonstrate differences in skin care knowledge, attitudes,~     and behaviors, compared to men with lower subscores.~   "
21724|NCT03282682|"~     This study examines the effect of 12-week strength training program with and without~     testosterone replacement therapy (TRT) on body composition, physical function, selected~     biochemical markers of metabolic health, molecular parameters of training adaptation and the~     quality of life patients with ADAM. The investigators believe, that strength training program~     performed 2 times per week for 12 weeks can improve body composition (decrease fat mass and~     gain lean mass), muscle strength, muscle power and general quality of life in all training~     groups. In addition, combination TRT and strength training could help decrease fat mass,~     improve BMI, cardio-respiratory fitness and thus provide optimal therapy combination for~     hypogonadal ageing males.~   "
21725|NCT03282669|"~     Cesarean deliveries are the most commonly performed surgery in the United States and account~     for 32.9% of all births.8,9 The ASA recommends the use of neuraxial opioids of post-cesarean~     analgesia partly because respiratory depression in the obstetric population, as measured by~     intermittent respiratory rate and pulse oximetry, is reported to be low (0-1.2%).10,11~     Respiratory depression lacks a standard definition,12 but the most sensitive means of~     detecting respiratory depression is hypercapnia.1,3 Two recent studies using continuous~     hypercapnia (>50mmHg PaCO2) monitoring demonstrated higher rates of respiratory depression~     (17.8-37%) in healthy, non-obese women receiving intrathecal opioids for post-cesarean~     analgesia.13,14 In addition, supplemental opioids are required in the majority of women~     receiving intrathecal morphine and may increase the risk of respiratory depression.11,14~     Anesthesiologists debate whether neuraxial opioids or intravenous patient controlled opioid~     analgesia (PCA) are the safest practice for postoperative analgesia in obese parturients~     following cesarean delivery. The ASA recommendations to employ neuraxial analgesia~     post-cesarean delivery does not differentiate between non-obese and obese women who now make~     up 30.3% in US women of child-bearing age.2 Obesity has been described as a risk factor for~     respiratory depression in those receiving opioids via any route of opioid~     administration,11,15, 17 but whether obesity itself is the risk factor or associated~     co-morbidities such as sleep apnea is debated.~      Studies are conflicting whether intrathecal opioids or patient controlled intravenous opioids~     cause more respiratory depression. Several studies have documented the incidence of~     respiratory depression with IV PCA; the rates range from 0.19% to 5.2%, which are equivalent~     or higher than those reported for intrathecal opioids. (Hagle 16). Dalchow et al.~     demonstrated higher rates of hypercapnia in patients receiving intrathecal opioid compared~     with those receiving intravenous opioid via patient controlled analgesia in nonobese women~     following cesarean delivery. (Dalchow)~      The Topological Oscillation Search with Kinematical Analysis (TOSCA) monitor allows a~     noninvasive method to measure transcutaneous carbon dioxide levels, with relative accuracy~     compared to arterial carbon dioxide monitoring.4-7 No studies have examined transcutaneous~     carbon dioxide levels in obese women following cesarean delivery using any form of~     postoperative analgesia. The investigators propose a randomized controlled trial using~     continuous transcutaneous carbon dioxide monitoring to evaluate the degree of respiratory~     depression in obese women receiving neuraxial opioid compared to intravenous opioid via PCA~     for post-cesarean analgesia.~      Two studies have demonstrated high rates of hypercapnia in non-obese women following~     administration of intrathecal morphine for cesarean delivery in the postpartum period.~     (Dalchow, Bauchat) Dalchow et al. demonstrated higher rates of hypercapnia in women receiving~     intrathecal diamorphine than intravenous morphine delivered via patient controlled analgesia.~     It is unclear whether intrathecal morphine causes more or less respiratory depression than~     intravenous opioid delivered via patient-controlled analgesia in obese women.~      This study will add to the understanding of respiratory function in the immediate postpartum~     period in obese women using opioids via intrathecal or intravenous routes. This study will~     better inform guidelines for the postpartum analgesic route of choice in the obese obstetric~     population and allow the investigators to make recommendations for the detection and~     prevention of respiratory depression after opioid administration in the obstetric population.~      Objective is to examine the transcutaneous carbon dioxide levels in obese women using either~     intrathecal morphine or intravenous patient-controlled hydromorphone for post-cesarean~     analgesia.~      The hypothesis is carbon dioxide levels will be significantly higher in obese women receiving~     intrathecal morphine versus obese women receiving intravenous patient controlled intravenous~     hydromorphone.~   "
21726|NCT03282656|"~     A promising approach for the treatment of genetic diseases is called gene therapy. Gene~     therapy is a relatively new field of medicine that uses genetic material (mostly DNA) from~     the patient to treat his or her own disease. In gene therapy, the investigators introduce new~     genetic material in order to fix or replace the patient's disease gene, with the goal of~     curing the disease. The procedure is similar to a bone marrow transplant, in that the~     patient's malfunctioning blood stem cells are reduced or eliminated using chemotherapy, but~     it is different because instead of using a different person's (donor) blood stem cells for~     the transplant, the patient's own blood stem cells are given back after the new genetic~     material has been introduced into those cells. This approach has the advantage of eliminating~     any risk of GVHD, reducing the risk of graft rejection, and may also allow less chemotherapy~     to be utilized for the conditioning portion of the transplant procedure. The method used to~     introduce the gene into the patient's own blood stem cells is to engineer and use a modified~     version of a virus (called a 'vector') that efficiently inserts the correcting genetic~     material into the cells. The vector is a specialized biological medicine that has been~     formulated for use in human beings.~      The investigators have recently discovered a gene that is very important in the control of~     fetal hemoglobin expression. Increasing the expression of this gene in sickle cell patients~     could increase the amount of fetal hemoglobin while simultaneously reducing the amount of~     sickle hemoglobin in their blood, and therefore potentially cure the condition. In summary,~     the advantages of a gene therapy approach include: 1) it can be used even if the patient does~     not have a matched donor available; 2) it may allow a reduction in the amount of chemotherapy~     required to prepare the patient for the transplant; and 3) it will avoid the strong medicines~     often required to prevent and treat GVHD and rejection. The goal is to test whether this~     approach is safe, and whether using gene therapy to change the expression of this particular~     gene will lead to increased fetal hemoglobin production in people with sickle cell disease.~   "
21727|NCT03282643|"~     The study is designed to compare the efficacy and safety of oral rivaroxaban and subcutaneous~     low-molecular-weight heparin in preventing femoral venepuncture associated thrombosis among~     cancer patients.~   "
21728|NCT03282630|"~     Sphenopalatine ganglion (SPG)-acupuncture has been shown to exhibit distinct effects in~     treatment of nasal inflammatory disease. Investigators aimed to assess the effects of SPG~     acupuncture in patients with seasonal allergic rhinitis. The randomized, double-blind,~     controlled clinical trial enrolled participants with seasonal allergic rhinitis. Participants~     will be randomly assigned to either active SPG-acupuncture group or sham-acupuncture group.~     All participants will be provided four times of acupuncture in 4 weeks, and then follow-up of~     4 week.~      Primary trial outcomes are change in symptoms and change in need for medication. The primary~     outcomes will be measured in baseline, week1, week2, week3, week4, week 6 and week 8.~     Secondary outcomes include the changes in nasal patency (nasal airway resistance and nasal~     cavity volume), exhaled nasal nitric oxide.The investigators also evaluate change in~     neuropeptides (substance P, vasoactive intestinal peptide,neuropeptide Y) and inflammatory~     cytokines (interleukin(IL)-4, IL-5, IL-8, IL-17a, IL-22, IL-25, interferon-γ, tumor necrosis~     factor-α, transforming growth factor(TGF)-β1, TGF-β2, TGF-β3,Chemokine, Eotaxin) in nasal~     secretions as secondary outcomes. The secondary outcomes will be measured in baseline, week1,~     week4 and week 8.~   "
21729|NCT03282617|"~     This study is carried out to find out the safety and recommended dose of CD137L-DC-EBV-VAX in~     nasopharyngeal cancer. CD137L-DC-EBV-VAX is a product made from one of our own immune system~     cells (dendritic cell, DC). Dendritic cells are immune cells that help to stimulate our~     body's T lymphocytes to fight cancer by presenting specific proteins from the cancer cells.~     The investigators have developed in the laboratory a highly effective dendritic cell which is~     primed to activate T cells with the Epstein-Barr virus (EBV) proteins. It is hoped that this~     will stir an immune response to recognize NPC cells and kill them as part of body's immune~     surveillance system.~   "
21730|NCT03282604|"~     The nasotracheal intubation is preferred for oral surgery; it provides an easier view of the~     surgical field. However, nasotracheal tubes are produced by foreign countries. Tubes are~     often not fitted in anatomy of Korean people because of small nostril. When the size of the~     tube is chosen by nostril size, the length of nasotracheal tube is not appropriate to the~     glottis. The aim of this study is to evaluate the appropriateness of the tube depth and to~     suggest the ideal length of the nasotracheal tube during the intubation of the selected~     tracheal tube in consideration of the size of the nasal cavity in Koreans. 146 patients (73~     males and 73 females) who are scheduled for nasal intubation for general anesthesia will be~     enrolled. The primary outcome is the ideal length of tube that allows the distance from the~     vocal cords to the proximal portion of the tube cuff to be greater than 2 cm and the tip of~     the intubated tube to be located 5 ± 2 cm above the tracheal carina. The size of nostril,~     length from the nare to the carina and vocal cord are measured.~   "
21731|NCT03282591|"~     Study of the efficacy, safety, and tolerability of serlopitant for the treatment of~     refractory chronic cough~   "
21732|NCT03282578|"~     Design:~      Investigator Initiated Prospective Randomised Trial~      Study Centre's:~      Melbourne Private Hospital Royal Melbourne Hospital~      Study Hypothesis:~      Use of the SternaLock 360 will reduce the incidence of sternal motion > 2mm by absolute~     difference of 40% at 6 weeks of surgery compared to stainless steel wiring.~      Use of the SternaLock 360 will improve bone healing and quality of recovery after surgery~     compared to stainless steel wiring~      Study Objective:~      To determine if the SternaLock 360 system reduces sternal instability, increases bone~     healing, and improves quality of recovery compared to stainless steel wiring of the sternum,~     after cardiac surgery involving median sternotomy~      Inclusion Criteria:~      Age ≥ 18 year old Elective cardiac surgery Primary cardiac surgical procedure No evidence of~     infection at time of surgery Sufficient English language to complete the Postoperative~     Quality of Recovery Survey~      Exclusion Criteria:~      Previous sternotomy (redo) Clinical sternal deformity Home locality preventing follow-up~     (e.g. remote regional, interstate or overseas patient)~      Number of Planned Subjects:~      50~   "
21733|NCT03282565|"~     The purpose of this study is to examine if thigh muscle weakness and the lack of muscle~     activation that accompanies ACL injury and reconstruction can be improved with functional~     resistance training.~   "
21774|NCT03282032|"~     To observe the effect of one-lung ventilation (OLV) preconditioning on perioperative~     oxygenation during thoracic surgery.~   "
21738|NCT03282500|"~     The purpose of this research is to investigate the influence a mindfulness based cognitive~     therapy (MBCT) intervention will have on internalizing and externalizing problems in children~     and adolescents that have suffered a Traumatic Brain Injury (TBI). MBCT is a manualized~     intervention developed to increase social-emotional resiliency through mindful attention.~     Internalizing problems refer to a set of symptoms in which a person over-controls their~     emotions and results in social withdrawal, feelings of worthlessness, depression, and anxiety~     (Bloom et al., 2001). In contrast, externalizing problems refer to an under-control of~     emotions which results in conduct problems, impulsive behavior, and aggression. Social and~     emotional difficulties are prominent consequences of childhood TBI. Left untreated or~     undertreated, these problems often persist into adulthood, producing a wide range of~     challenges adapting in personal and vocational domains. At present, there are minimal~     non-pharmacological therapeutic approaches that effectively treat psychosocial deficits~     unique to TBI. Developing innovative, evidence based methods is essential in helping children~     recover from the injury.~   "
21739|NCT03282487|"~     Adrenal insufficiency is a condition where the adrenal glands do not produce an adequate~     amount of steroid hormones. The aetiology of adrenal insufficiency can be primary or~     secondary. Patients will adrenal insufficiency have increased morbidity and mortality. In~     recent years there has been concern regarding what is the optimal dose and regimen of steroid~     replacement for patients. Unfortunately there is no accurate way of monitoring if a patient~     is on too much or too little steroid. We have shown in hypopituitary patients with secondary~     adrenal insufficiency that higher doses of hydrocortisone may be harmful. This reason for~     this is not fully understood.~      In recent years, a modified release hydrocortisone tablet (Plenadren) taken once per day~     (unlike conventional immediate release hydrocortisone which requires twice or thrice daily~     regimen) has come on the market. This tablet has shown to a have a steroid profile that more~     closely resembles normal physiology, avoiding the peak steroid levels that occur during~     thrice daily regimens, which may be of importance for improving outcome in adrenal~     insufficiency patients. It also shown improved cardiovascular risk factors, glucose~     metabolism and quality of life in compared to conventional treatment.~      The aim of our study is to assess the effect of hydrocortisone therapy on how the body uses~     and breaks down (metabolises) steroids. This will be done by several different research~     methods: by measuring markers of steroid action and metabolism in blood, urine and within the~     fat tissue under the skin in the abdomen. These results will be compared in the same patient~     while on their usual hydrocortisone and after switching to modified release hydrocortisone~     for 12 weeks, and to results from a normal healthy control group who are not on steroid~     replacement.~      This will be the first study to assess the impact of this new modified release hydrocortisone~     in relation to tissue steroid metabolism. The results will potentially help us to improve the~     treatment of patients with steroid deficiency and reduce the side effects seen in these~     patients.~   "
21740|NCT03282474|"~     This is a single arm multicenter pilot study to provide preliminary evidence whether~     sofosbuvir (SOF) is efficacious and can be safely used in patients with chronic Hepatitis E~     virus infection.~   "
21741|NCT03282461|"~     The primary study objective is to determine if microdoses of ABY-029 (up to 6X) lead to~     detectable signals (defined as signal-to-noise ratio, SNR ≥10, with wide-field iFI) in~     sampled tissues with an EGFR (epidermal growth factor receptor) pathology score ≥ 1 based on~     histological staining.~      The secondary study objective is to assess ex vivo the specificity of tumor binding in~     resected specimens by measuring the corresponding molecular uptake and concentrations using~     histopathology.~   "
21742|NCT03282448|"~     This pilot study will explore the feasibility and acceptability of implementing a~     family-based treatment, using HIPAA-compliant video-based communication technology, for~     adolescents (pregnant and post-delivery) with peripartum depressive symptoms within the~     context of home visiting.~   "
21743|NCT03282435|"~     to evaluate the prognosis of non-small cell lung carcinoma patients under CIK cellular~     treatment with PD-1 blocking on top of the standard therapy~   "
21744|NCT03282422|"~     The main objective:~      To determine the effectiveness of a treatment that combines the application of a functional~     upper limb orthosis together with a home-based program of specific tasks in children with~     unilateral cerebral palsy versus a home-based program of specific tasks in improving~     structure and function, activity and participation.~      Hypothesis:~      The application of a functional upper limb orthosis together with a home-based program of~     specific tasks in children with unilateral cerebral palsy results in a greater improvement in~     structure and function, activity and participation compared to the implementation of a~     home-based specific task program.~   "
21745|NCT03282409|"~     The study aims to develop and validate a prediction score of chronic renal disease occurrence~     within 3 years after ICU discharge in patients who suffered an acute kidney failure during~     ICU stay and recovered normal renal function at 90 days following their discharge.~      The primary study outcome is the incidence of chronic renal disease within the first 3 years~     after ICU discharge, defined by a lower glomerular filtration rate (GFR) under 60~     mL/minute/1.73m2.~   "
21746|NCT03282396|"~     The goal of this clinical research study is to learn if ibrutinib can help to control mantle~     cell lymphoma (MCL). The safety of this drug will also be studied.~   "
21747|NCT03282383|"~     To identify the potential serum biomarkers with regard to the severity of pneumonia, and to~     further evaluate the prognostic value of these markers.~   "
21748|NCT03282370|"~     A study of the study vaccine (JECEVAX- VABIOTECH-Vietnam) and a licensed vaccine~     (JEVAX-VABIOTECH-Vietnam) is conducted in Vietnamese children, aged 9 to 24 months to assess~     the safety of the study vaccine compares to licenced vaccine. Two hundred and twenty children~     are enrolled and randomly assigned into 2 groups (110 children/group), each of which receive~     2 doses of study / control vaccine subcutaneously, at 28-34 days interval. Safety data~     included immediate reaction at the injection site and systemic reaction within 30 min of~     administration, solicited and unsolicited adverse events occurs from the 1st dose to 28-34~     days after first dose and from the second dose to 28-34 days after 2nd dose. SAE (from start~     of first dose to 28-34 days after second dose).~   "
21749|NCT03282357|"~     The objectives of this study are to evaluate the effectiveness and safety of Radiesse for the~     correction of nasolabial folds (NLFs)~   "
21750|NCT03282344|"~     The purpose of this study is to test any good and bad effects of the combination of study~     drugs called NKTR-214 and nivolumab.~   "
21751|NCT03282331|"~     Prospective, randomized clinical multicentric study, in ICU, during preoxygenation for the~     intubation of hypoxemic patients.~      Electrical impedance tomographic evaluation of lung morphology variations according to the~     preoxygenation technique : Comparison of Standard Oxygenation, High Flow Nasal Oxygen~     Therapy, and NonInvasive Ventilation~   "
21752|NCT03282318|"~     The purpose of this study is to investigate efficacy, safety and tolerability of ASP6294 in~     female participants with Bladder Pain Syndrome/Interstitial Cystitis (BPS/IC). This study~     will also investigate the pharmacokinetics (PK) and pharmacodynamics (PD) of ASP6294 in~     female participants with BPS/IC.~   "
21753|NCT03282305|"~     Nonalcoholic fatty liver disease (NAFLD) is a progressive liver disease ranging from simple~     steatosis to cirrhosis of the liver. Nonalcoholic fatty liver (NAFL) without substantial~     hepatocellular injury is thought to be relatively benign whereas nonalcoholic steatohepatitis~     (NASH) is characterized by hepatocyte steatosis, ballooning, inflammation and varying degrees~     of fibrosis from none to cirrhosis. NASH is strongly associated with insulin resistance and~     metabolic syndrome and thus is recognized as a major public health concern as the most~     prevalent liver disease.~      Liver biopsy is the gold standard for a diagnosis of NASH. However, given the large~     population of patients at risk for NASH, liver biopsy is not a practical method for~     determining which patients may benefit from NASH therapy. Non-invasive methods to estimate~     inflammation and fibrosis are in clinical use, but there remains a dichotomy between gold~     standard inclusion criteria and end points that are utilized in clinical trials and real~     world diagnostic methods that are more common in clinical practice.~      Thus, the investigators would like to conduct an observational study to head-to-head compare~     the non-invasive methods and liver biopsy in differential liver steatosis and liver biopsy in~     a real-world setting. Also, by following up patients for a relatively long time (proposed 10~     years), the investigators can present the natural history of disease progression.~   "
21754|NCT03282292|"~     Randomized controlled trial comparing femoral vs internal jugular insertion site of central~     venous catheters (CVC) in newborns and infants undergoing cardiac surgery. The experimental~     hypothesis is that the jugular insertion site is superior to the femoral in terms of catheter~     colonization.~   "
21755|NCT03282279|"~     The investigators retrospectively analysed the complication rate of ultrasound guided~     transvaginal oocyte retrieval (TVOR) from all the procedures performed between 1996 and~     October 2016 in a tertiary level university based fertility clinic.~   "
21756|NCT03282266|"~     The objective of this randomized control trial is to gain clinical insight on the use of~     pulmonary artery denervation (PADN) for the treatment of pulmonary arterial hypertension~     (PAH). The primary objective is to assess effectiveness and safety of PADN for the treatment~     of PAH.~   "
21757|NCT03282253|"~     In this study, the investgatiors aimed to investigate the associations between serum levels~     of stearoyl-CoA desaturase-1（SCD-1） and the disease severity as well as the presence of~     adverse clinical events, such as local complications, organ failure, mortality and so on.In~     this prospective study, participants were divided into two groups based on serum SCD-1~     concentration on admission and prospectively observe the disease severity and clinical~     outcomes of them.~   "
21758|NCT03282240|"~     This randomized, modified double-blind, active-controlled, multi-center trial will assess the~     safety and immunogenicity of the high-dose quadrivalent influenza vaccine (QIV-HD) compared~     to either the licensed or investigational high-dose trivalent influenza vaccine (TIV-HD) in~     adults.~   "
21759|NCT03282227|"~     This is an open-label, twelve-month safety study. There is a screening period followed by a~     run-in period to record migraine activity. Qualified subjects will receive study medication~     for up to twelve months for the treatment of multiple migraine attacks. Using the eDiary to~     confirm they are experiencing a qualified migraine, subjects will self-administer the patches~     and respond to questions in the eDiary post treatment administration.~   "
21760|NCT03282214|"~     The purpose of this pilot study is to examine a 12-week self-management energy conservation~     program (ECAM)'s effects on fatigue, and secondarily on sleep, physical activity, anxiety and~     depression, self-efficacy, and beliefs about fatigue in a group of Thai women with breast~     cancer who are undergoing chemotherapy. We will also evaluate how well women like the~     intervention, how easy it is to use and whether women will do the activities.~   "
21761|NCT03282201|"~     The rate of hip, knee arthroplasties and their revision are increasing every year. The~     incidence of blood transfusion in these operations are reported 18%, 68%, and 39%, 67%,~     respectively. Blood transfusion is known to increase the risk of pulmonary, septic, wound and~     thromboembolic complications and is related to mortality. Restrictive transfusion protocols~     has cost-effective results in terms of reducing these complications, promoting early~     discharge and reduced frequency of re-admission.~      Within this context, we aimed to evaluate the transfusion practice in our hospital, define~     the transfusion indicators and compare the transfused and non transfused patients in terms of~     recovery.~   "
21762|NCT03282188|"~     Open-label, non-randomised, single centre study which will assess the presence of reovirus~     (Reolysin®), following intravenous administration with or without Granulocyte-macrophage~     colony-stimulating factor (GM-CSF) given to patients prior to surgery for metastatic~     melanoma. All patients will receive an initial low 'immunisation' dose of intravenous~     reovirus. Patients will be enrolled sequentially in to each of the two cohorts receiving~     either reovirus alone, or reovirus plus GM-CSF. For this study we anticipate 8-16 evaluable~     patients, up to 8 for each group. The endpoints of this study will compare the 2 treatment~     groups for reovirus tumour infiltration and replication. Compare the neutralising antibody~     development and cell-mediated immune response and identify any adverse events and laboratory~     toxicities.~   "
21763|NCT03282175|"~     The aim of this study was to investigate the acute and chronic effect of elastic resistance~     exercise in elderly women living in a nursing home. The primary outcome was the functional~     performance and hand grip strength. The secondary outcomes were myokines and inflammatory~     markers analysis.~   "
21764|NCT03282162|"~     The main aim of the study is to investigate whether intranasal oxytocin (24IU) increases the~     affective processing of touch in general or whether it's effect vary according to the~     affective valence of the touch (positive, neutral, negative). Moreover, associations with~     trait autism will be explored.~   "
21765|NCT03282149|"~     Preliminary Evaluation of Safety, Tolerability, and Efficacy of XT-150 for the Treatment of~     Osteoarthritic Pain - Dose escalation~   "
21766|NCT03282136|"~     Incretin therapy is a treatment for type 2 diabetes (T2DM) affected by heart failure (HF). In~     this study the investigators will recruit T2DM patients affected by HF with depressed~     ejection fraction and treated by Cardiac resynchronization therapy (CRT). These patients will~     randomly be treated by incretin v/s conventional hypoglicemic drugs. In this patients~     investigators will report at follow up CRT-d responders rate, mortality, and hospital~     admission for HF worsening. Incretin may reduce hospital admissions for HF in T2DM v/s~     conventional hypoglicemic drugs.~   "
21767|NCT03282123|"~     This multi-site, open-label, Phase 2, lead-in study assesses the safety and effect of~     3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in participants diagnosed~     with at least severe posttraumatic stress disorder (PTSD). Therapy teams that have been~     identified and trained to work on the sponsor's planned Phase 3 studies will treat at least~     one open-label participant in this study. The study will be conducted in up to N=60~     participants. A flexible dose of MDMA, followed by a supplemental half-dose unless~     contraindicated, is administered during the Treatment Period with manualized psychotherapy in~     three open-label monthly Experimental Sessions. This ~12-week Treatment Period is preceded by~     three Preparatory Sessions. During the Treatment Period, each Experimental Session is~     followed by three Integrative Sessions of non-drug psychotherapy. The Primary Outcome~     measure, the change in Clinician Administered PTSD Scale for DSM 5 (CAPS-5) from Baseline.~     Exploratory measures will address specific symptoms, or behavior that is sometimes related to~     PTSD. Drug safety will be assessed by measuring blood pressure, heart rate and body~     temperature during experimental sessions, collecting adverse events and measuring suicidal~     thoughts or behaviors with the Columbia Suicide Severity Rating Scale (CSSRS). This study~     will compare the effects of three open-label manualized Experimental Sessions of~     psychotherapy assisted by flexible doses of MDMA. Initial doses per Experimental Session~     include 80 mg or 120 mg of MDMA compounded with lactose, followed 1.5 to 2 hours later by a~     supplemental half-dose (40 mg or 60 mg). Total amounts of MDMA to be administered per~     Experimental Session range from 80 mg to 180 mg.~   "
21768|NCT03282110|"~     Experimental and clinical studies have indicated that acupuncture has a good effect for~     depression and comorbid pain. The purpose of this research is to compare the effect of~     comprehensive electro-acupuncture therapy and western medicine citalopram for for depressive~     disorder with comorbid psychogenic pain. This research is a assessor blinded, randomized~     controlled trials. 60 patients will be randomly divided into comprehensive~     electro-acupuncture group and western medicine citalopram for 8 weeks treatment and the~     therapeutic effect is done at the end of 1,2,4,6,8 week.~   "
21769|NCT03282097|"~     The Decisions about Cancer screening in Alzheimer's Disease (DECAD) study is the first study~     to test if an evidence-based decision aid for AD caregivers can support decision-making about~     mammography and improve the quality of medical decision-making about breast cancer screening.~     This large randomized controlled trial will recruit 426 dyads of older women with AD and a~     family caregiver from 24 primary care practices in central Indiana to test this decision aid~   "
21770|NCT03282084|"~     Gastroesophageal reflux disease (GERD) is a common chronic condition, affecting approximately~     20% of the American adult population. Proton pump inhibitors (PPIs) are now the mainstay of~     medical therapy for symptoms of GERD. Despite their efficacy, several studies have shown that~     a significant proportion of GERD patients are either partial or non-responders to PPI~     therapy, defined as symptoms of heartburn and/or regurgitation not relieved by either a~     standard or double dose of a PPI during a minimum trial of 8 weeks. If GERD symptoms persist,~     further testing is required. This study will mirror the real world setting to assess the~     value of published guidelines which recommend specific testing and treatment.~   "
21771|NCT03282071|"~     Aims: To enhance mental well-being of adolescents, adults and their families by creating a~     positive, happy and joyful environment in the community.~      Targets: Parents aged 12-59 and their family members in Hong Kong.~      Methods: Joyful Parenting Pilot Project will adopt the public health and family-focused~     approach, under the brand name of Joyful@HK Campaign. Evidence-based and Evidence~     Generating approach with vigorous study design, both qualitative (e.g. focus groups) and~     quantitative (e.g. randomised controlled trial), will be used to evaluate the overall~     programme effectiveness including follow-up of at least one month (best science). To ensure~     the practicability and sustainability of the CBEP, we will engage community partners with~     strong track records of best practice to design, plan, and implement the intervention. This~     project will use innovative and integrated positive psychology and public health theories and~     methods to plan brief, simple, and cost-effective intervention.~      Significance: By using best science in the design and evaluation of intervention programme,~     and the best practice of the partners' skills, experience and strong connection with~     service targets in the community, the intervention, if proven to be effective, for promoting~     sharing, mind and enjoyment and enhancing mental wellbeing can be further developed and~     widely disseminated to and adopted by the practitioners in the health and social service~     sectors for replication and improvement to benefit the whole population.~   "
21772|NCT03282058|"~     Endoscopic skull base surgery is a relatively new procedure that is now a standard of care~     for surgeries at the base of the skull; however there are no studies that examine the healing~     process of the nasal lining with the use of silastic (silicone) stents (or splints) that~     might be placed at the time of surgery. While there is some evidence to suggest that the use~     of stents improves wound healing, the decision to use a stent or not is currently up to the~     preference of the surgeon. To investigate the impact of stents on post-surgical healing, the~     investigators at Vancouver General Hospital will compare patients undergoing trans-sphenoidal~     pituitary surgeries with septal flap reconstruction with the use of silastic stents to line~     the septal donor site, and compare their recovery to those who did not receive stents. The~     investigators hypothesize that the use of silastic stents in endonasal surgery increases the~     rate of mucosal healing, and better quality mucosal regeneration, and with no effect on the~     patients experience after surgery. In this randomized control trial the investigators aim to~     recruit 26 (13 in each arm) study participants. The primary outcome is to determine the~     effect of silastic stunting on healing of the naso-septal flap donor site. This objective~     will be achieved by assessment of endoscopic photographs of healing tissue and histologic~     assessment of healing tissues. The secondary outcome involves questionnaires that measure the~     patient's subjective nasal symptoms prior to and following endoscopic skull based surgery.~     Total time commitment for the study participant is about 4 months across 4 study visits (all~     of which are part of standard of care): the assessment visit, surgery, 4 weeks post-operative~     follow up visit and 12 week post-operative follow up visit.~   "
21773|NCT03282045|"~     The primary objective of this multicenter, single-blind, randomized, placebo-controlled,~     prospective, comparative study with parallel design and 4-arms is to evaluate superiority of~     Lysobact Complete Spray® against placebo and non inferiority of Lysobact Complete Spray®~     against active comparators (Tantum Verde® and Pharyngal®) in terms of efficacy based on the~     pain VAS scores evaluated by the patient using Sore Throat Pain Intensity Scale (STPIS).~   "
21776|NCT03282006|"~     Febrile urinary tract infections and urosepsis are common and potentially serious infections~     that require effective antimicrobial treatment. The duration of parenteral treatment depends~     on oral alternatives. These alternatives are few and due to antimicrobial resistance,~     quinolones are standard of care. The increased use of quinolones is concerning because of~     its negative ecological aspects and it is confirmed an increasing incidence of resistant~     E.coli to quinolones in Norwegian isolates.~      Pivmecillinam is an antibiotic with high susceptibility to E.coli but the evidence for~     treating febrile urinary tract infections is insufficient. This trial will investigate the~     efficacy and safety of pivmecillinam in treating pyelonephritis and urosepsis caused by~     E.coli.~      The hypothesis is that urosepsis can safely be treated with pivmecillinam when it is given~     after 2-3 days with empirical i.v. antibiotics.~   "
21777|NCT03281993|"~     Apnea test (AT) is the most important clinical test performed usually at the end of brain~     death (BD) diagnosis procedure. Traditional insufflation apnea test (I-AT) cannot be~     completed in patients with extremely compromised lung function due to rapid blood~     desaturation and circulatory disturbances. Therefore the investigators decided to verify~     alternative AT options such as continuous positive airway pressure apnea test (CPAP-AT) in~     patients with good and poor baseline oxygenation, before implementing them in currently~     reviewed Polish BD criteria.~   "
21778|NCT03281980|"~     Burden: In developing countries, an estimated 219 million children do not reach their maximum~     potentiality because of poverty and associated risk factors. More than half of the~     Bangladeshi children <5 years are at risk for developmental delay due to poverty and~     sub-optimal home stimulation. Sometimes poor people become poorer due to catastrophic~     expenditure on health care and fall into the vicious cycle of poverty~      Knowledge gap: Although, there is evidence that conditional cash transfer helps develop poor~     people' health and nutritional status, little is known about the effect of unconditional cash~     transfer and health education (HE) programmes along with psychosocial stimulation on~     children' cognition and behaviour.~      Relevance: The study will bring an opportunity to evaluate the effect of transferring~     unconditional cash and health education programme along with psychosocial stimulation to poor~     families under safetynet programme of Bangladesh Govt. in rural areas. The study will also~     document direct and indirect cost to measure cost effectiveness that will help in decision~     making to implement the project if it shows benefits to children's development.~      Primary Hypothesis (if any):~        -  Unconditional cash transfer (UCT) and health education (HE) programme will improve~          child's cognitive, motor and language development and behaviour compared to no~          intervention group.~        -  Adding psychosocial stimulation to an unconditional cash transfer (UCT) and health~          education (HE) programme will will have an additive effect on Childs's cognitive, motor~          and language development and behaviour compared to the control groups~      Secondary Hypothesis:~      Additionally the intervention will~        -  be cost effective,~        -  reduce mothers' depressive symptoms and improve their self esteem~        -  improve children's growth and household food security status~        -  reduce domestic violence~        -  Health seeking behaviour and health care expenditure~      Long-term goal: our ultimate goal is to find a suitable infrastructure to take to scale early~     child development activities for the whole country.~      Methods: It is a Cluster Randomized Controlled Trial with three-arms (i) UCT+HE+Psychosocial~     stimulation (ii) UCT+HE and iii) Comparison group.~   "
21779|NCT03281967|"~     The objective of the study is to compare the outcomes after a surgical procedure with~     minimally invasive Ponto surgery (MIPS, test group) and tissue preservation surgery (control)~     for placing Oticon Medical Ponto implants and abutments.~   "
21780|NCT03281954|"~     The main purpose of this study is to learn if the usual chemotherapy given before surgery~     (neoadjuvant therapy) for breast cancer plus the experimental drug, atezolizumab, is better~     than the usual chemotherapy plus a placebo. (A placebo is a drug that looks like the study~     drug but contains no medication.) The usual chemotherapy in this study is paclitaxel (WP) and~     carboplatin followed by doxorubicin and cyclophosphamide (AC) or epirubicin and~     cyclophosphamide (EC). Usually, after neoadjuvant therapy and surgery for triple negative~     breast cancer, no additional treatment is given unless the cancer returns. This study will~     also look at continuing treatment after surgery with atezolizumab or the placebo. To be~     better, atezolizumab given with the neoadjuvant therapy should be better at: 1) decreasing~     the amount of tumor in the breast than the placebo given with the usual chemotherapy and 2)~     decreasing the chance of the cancer from returning after surgery.~      Another purpose of this study is to test the good and bad effects of atezolizumab when added~     to the usual chemotherapy. Atezolizumab may keep your cancer from growing but it can also~     cause side effects.~   "
21781|NCT03281941|"~     ToAST study is a pilot study aiming to establish the safety profile of using inhaled~     capsaicin challenge in patients with severe asthma. The investigators will also explore the~     differences in cough symptoms and threshold in patients with and without bronchial~     thermoplasty.~   "
21782|NCT03281928|"~     This study intends to characterize the affect of sodium and potassium citrate in the diet on~     renal function.~   "
21783|NCT03281915|"~     to evalute the effect inguinal and subinguinal approach of varicoceclectomy on semen~     parameter for patients complaining of varicocele with normal semen parameter (pain is the~     main complaint)~   "
21784|NCT03281902|"~     This research trial studies genetic profiles in blood and tumor samples from patients with~     estrogen receptor positive and HER2 negative breast cancer that has spread to other places in~     the body who are receiving palbociclib and endocrine therapy. Examine the genetic changes~     associated with the cancer and comparing the genetic material from the cancer tissue with the~     genetic material found in the blood may help doctors to develop customized treatment for~     breast cancer.~   "
21785|NCT03281889|"~     This research study is studying proton radiation as a possible treatment for brain tumor that~     requires radiation.~      The radiation involved in this study is:~      -Proton Radiation~   "
21786|NCT03281876|"~     The purpose of this study is to test if the vaccine is working well in COPD patients aged 40~     to 80 years old to reduce episodes of worsening symptoms (exacerbations) and to gather~     further information on safety and immune response.~      In the current study, COPD patients with a history of acute exacerbations will receive 2~     doses of the investigational vaccine or placebo intramuscularly according to a 0, 2 month~     vaccination schedule, in addition to standard care.~      The effect of vaccination against two pathogens known to cause exacerbations (Non-typeable~     Haemophilus influenza [NTHi] and Moraxella catarrhalis [Mcat]) will be evaluated at~     pre-defined timepoints (scheduled study visits).~      In addition to the scheduled study visits, additional study visit(s) and/ or phone contact(s)~     will take place for each acute exacerbation of COPD occurring from first vaccination up to~     study conclusion.~   "
21787|NCT03281863|"~     clinical audit on the Managment of rheumatic fever in assiut university children hospital.~   "
21788|NCT03281850|"~     This study will help us learn more about how maternal health can influence child health.~   "
26043|NCT03226067|"~     The purpose of this study is to assess the safety and efficacy of GKT13783 in patients with~     Primary Biliary Cholangitis (PBC) who are taking a stable dose of ursodeoxycholic acid (UDCA)~     treatment, and have persistently high levels of a liver enzyme called Alkaline Phosphatase~     (ALP).~   "
21789|NCT03281837|"~     Knee osteoarthritis (OA) is among the most common causes of musculoskeletal pain and~     disability. At present, there is no cure for OA. Therefore, the primary aims of therapy are~     to reduce pain, maintain or improve function and mobility, and prevent or slow the~     progression of adverse changes to the joint tissues, while keeping potential therapeutic~     toxicities to a minimum. Current treatment guidelines begin with non-pharmacologic~     modalities, such as patient education, weight loss, and physical therapy. Several~     exercise-based therapeutic approaches, such as aerobic exercise programs, range-of-motion~     exercises, and muscle-strengthening exercises are recommended and have shown clinical benefit~     in randomized, controlled clinical trials. However, non-pharmacologic approaches frequently~     provide insufficient pain relief and restoration of function and mobility, and pharmacologic~     modalities become necessary. Although simple analgesics such as acetaminophen provide relief~     for many OA subjects with mild to moderate pain, alternatives should be considered for~     subjects who fail to obtain adequate symptomatic relief with these measures.~      This post-market, single blind, multicenter, randomized, controlled clinical study is~     designed to enroll a relatively young, active population of subjects with patellofemoral~     osteoarthritis (PFOA) and/or tibiofemoral osteoarthritis (TFOA), and to compare responses to~     treatment with 2 weekly intra-articular (IA) hyaluronan (HA) injections, with each injection~     given 1 week apart, of HYMOVIS combined with a physical exercise program (PEP) to PEP alone.~     Because PEP or exercise programs may be considered the first line standard of care in OA knee~     pain, particularly in younger, active patients, the hypothesis of the study is that Hymovis~     combined with PEP program provides greater relief of pain associated with knee OA in the~     enrolled study subjects than with use of PEP alone.~      The study provides for subjects randomized to the PEP alone study group to cross over to~     HYMOVIS+PEP if improvement has not been achieved by the 3 month follow up visit.~      Subjects will be recruited over a 6 month period. The duration of the trial per center will~     be approximately 15 months. This includes the enrollment period of 6 months, the follow-up~     period at 3 and 6 months and the additional follow-up period for patients who crossed-over;~     they will be followed for an additional 6 months following the initial 3month follow-up. The~     trial will end when the last subject makes the last visit.~   "
21790|NCT03281824|"~     This open-label study assessed the safety, tolerability and pharmacokinetics of~     ALT-P7(HM2-Drug Conjugate) in patients with HER2-positive metastatic breast cancer who have~     progressed on previous Trastuzumab-based therapy. Patients received ALT-P7(0.3 mg/kg~5.4~     mg/kg, 7 groups) intravenously on Day 1 of each 3-week cycle.~   "
21791|NCT03281811|"~     This pilot phase II trial studies how well photodynamic therapy works in treating patients~     with mycosis fungoides that does not respond to treatment. Photodynamic therapy uses a drug,~     such as aminolevulinic acid hydrochloride, that becomes active when it is exposed to light.~     The activated drug may kill cancer cells.~   "
21792|NCT03281798|"~     This is a pilot study to evaluate the safety, feasibility and effectiveness of fetal~     cystoscopy in the prenatal diagnosis and therapy of fetuses with bladder outlet obstruction.~     Fetal bladder outlet obstruction is a rare congenital anomaly with severe consequences to the~     fetus. Because of the bladder outlet obstruction, amniotic fluid is diminished, drastically~     leading to abnormal development of the fetal lungs. In addition, the obstruction leads to~     significant kidney damage, including development of end stage renal disease. Fetal~     vesicoamniotic shunting is the clinical therapeutic option for these fetuses. However, the~     shunt has many complications including blockage and dislodgement. Fetal cystoscopy has been~     proposed as an alternative treatment with potential advantages over the shunt by allowing the~     correct prenatal diagnosis and specific treatment. Initial clinical trials have demonstrated~     favorable outcomes.~      The purpose of the study is to study the outcomes of maternal and fetal patients who are~     undergoing fetal intervention for severe, isolated lower urinary tract obstruction (LUTO) at~     Mayo Clinic in Rochester, Minnesota. The objectives are to evaluate the safety, feasibility,~     and effectiveness of fetal cystoscopy as an experimental procedure in avoiding perinatal~     death and renal impairment and to compare to our clinical experience with fetal~     vesico-amniotic shunting.~   "
21793|NCT03281785|"~     Muscle weakness and dysfunction are common problems in patients hospitalized in the intensive~     care unit. Respiratory muscle weakness during mechanical ventilation was recognized a state~     of muscular fatigue. The terminology 'ventilator-induced diaphragmatic dysfunction' (VIDD)~     originally was introduced to describe these effects of mechanical ventilation and respiratory~     muscle unloading on the diaphragm.~      Ultrasonography is becoming increasingly popular management of ICU patients. It is a simple,~     non-invasive and safe imaging technique that can be used for the assessment of distinctive~     diaphragmatic characteristics.~      Parameters such as amplitude and velocity of contraction, which can be assessed using M-mode~     ultrasound. In addition, static and dynamic (thickening fraction during inspiration)~     diaphragmatic thickness can also be measured by ultrasonography.~   "
21794|NCT03281772|"~     Current guideline directed medical therapies (GDMT) for hypertension (HTN) endorse a trial~     and error approach based on drug class. This pilot study will evaluate the efficacy of a~     Clinical Decision Support (CDS) program to assist providers with delivering a more~     personalized approach using individual renin-aldosterone levels and the mechanism of action~     of medications included in GDMT recommendations. The overarching goal is to achieve HTN~     control rates above the 2014 National Health and Nutrition Examination Survey reported rate~     of 53% in a timely fashion, by individualizing medication management, thereby reducing the~     patient risk of stroke, heart and renal disease, and other devastating HTN-related outcomes.~   "
21795|NCT03281759|"~     The purpose of this study is to evaluate early and delayed effects of Transcranial LED~     Therapy (TCLT) and determinate whether this therapy is effective for cognitive rehabilitation~     of Diffuse Axonal Injury patients after Traumatic Brain Injury.~   "
21796|NCT03281746|"~     This randomized pilot clinical trial studies how well preventive education works in~     decreasing caries formation in pediatric patients with leukemia. Prevention education may~     have an effect on factors important in causing cavities in pediatric patients with leukemia.~   "
21797|NCT03281733|"~     Background: As described in detail in the literature, patients identified with malnutrition~     are at increased risk of poor clinical outcomes. Despite this knowledge, malnourished~     patients do not always get optimal nutritional management while admitted into a hospital due~     to what we describe as gaps in care over the course of their admission.~      Objective: We hypothesized that the three main gaps in care were poor RDN/MD communication,~     excessive time spent NPO for procedures/testing, and/or inaccurate/incomplete dietary~     discharge instructions. The objectives of this study were to determine and to characterize~     gaps in nutritional care after a malnutrition diagnosis.~      Design: This retrospective study involved post-discharge chart reviews of malnourished adult~     medicine patients admitted to an acute care facility from September 1- November 30, 2014~     (n=242).~   "
21929|NCT03279991|"~     This project aims to create a digital platform for personal, clinical, diagnostic and~     environmental data collection, management and analysis of patients with cardiovascular and~     neurological disease or cancer admitted to the Neuromed Group clinics, associated with a~     biobanks of biological fluids and human tissues and a biotechnological platform for omics~     analysis, to encourage personalized, preventative and predictive care.~   "
21798|NCT03281720|"~     The purpose of this research study is to determine how feasible and accurate identifying and~     removing specific lymph nodes in the axilla (armpit) after neoadjuvant systemic therapy is~     when patients present with breast cancer that has spread to lymph nodes in the axilla. The~     specific lymph nodes removed would be determined at the time of diagnosis. If a biopsy proves~     that cancer has spread to a lymph node, a titanium clip will placed in it to mark it for~     future removal. That lymph node will be removed after systemic therapy and compared with the~     rest of the lymph nodes removed from that region.~   "
21799|NCT03281707|"~     This study evaluates the association between near infrared spectroscopy (NIRS) and indexed~     oxygen delivery (DO2i) and their possible correlation with postoperative organ failure.~   "
21800|NCT03281694|"~     Single-center, randomized, double-blind, placebo-controlled, proof-of-principle study to~     evaluate potential cognitive benefits of a single oral dose of AVL-3288 (3 mg) in the~     presence and absence of transdermal nicotine (7 mg/24 hrs) in healthy non-smokers, while~     monitoring the safety and tolerability of AVL-3288.~   "
21801|NCT03281681|"~     This is an open label, multi-center, Phase 1/2 clinical trial in subjects with recurrent~     adenocarcinoma of the ovary who have been previously treated with a minimum of two courses of~     platinum-based chemotherapy, and up to two additional cytotoxic regimens that may also have~     included platinum (no more than four total lines of prior therapy), with or without~     bevacizumab, whose cancer has recurred within six months of the most recent platinum-based~     chemotherapy. All eligible subjects will receive VAL 083 i.v. in a once weekly cycle until~     disease progression, development of other unacceptable toxicity, death, withdrawal of~     consent, loss to follow-up, or Sponsor ending the study, whichever occurs first.~   "
21802|NCT03281668|"~     The focus of this pilot study is to evaluate the feasibility of utilizing an evidenced-based~     high intensity interval training program (HIIT) to improve physical function in patients with~     knee osteoarthritis (OA).~   "
21803|NCT03281655|"~     The effects of a new vaginal cream containing visnadine (0.30%), prenylflavonoids (0.10%) and~     bovine colostrum (1%) will be evaluated in post-menopausal sexually active women affected by~     vulvovaginal atrophy (VVA).~      In a prospective cohort study, post-menopausal women affected by VVA will be enrolled. All~     women will undergo vaginal health index score (VHIS) evaluation and will complete the female~     sexual function index (FSFI) questionnaire at baseline evaluation (T0) and following 15 days~     of vaginal cream treatment with one application per day (T1). All the side effects will be~     recorded and an independent data safety and monitoring committee will evaluate the results of~     the study.~   "
21804|NCT03281642|"~     Tobacco consumption is a major public health problem, ranking second in the leading cause of~     morbidity and mortality worldwide, in 2010. The prevalence of tobacco smoking in hospitalized~     patients is evaluated around 20% and the management of tobacco reduction/cessation is an~     major issue for the course and outcome of many disorders.~      Recent recommendations published by the French National Health Authority (Haute Autorité de~     Santé, HAS) call for the involvement of all health professionals in helping patients to stop~     smoking and hospitalized patients are identified as a specific target. In addition, the~     meta-analysis of Rigotti et al. (2012) showed that the most effective programs (tobacco~     cessation) were those that include all patients, starting during the hospitalization with a~     specific follow-up of at least one month, and with the addition of nicotine replacement~     therapy. This combination increased the odds of successful tobacco cessation by 54%.~      The project aims to evaluate the short-term efficacy (1 month) of a nurse-based program on~     tobacco smoking consumption in a population of hospitalized patients.~   "
21805|NCT03281629|"~     In a double-blinded, randomized, parallel controlled design, patients with schizophrenia~     spectrum disorder will be exposed to active or sham repetitive transcranial magentic~     stimulation (TMS) which was guided by functional magnetic resonance image (MRI). Smoking~     reduction/cessation and brain functional connectivity changes will be assessed at baseline,~     different stages of rTMS and/or follow-ups.~   "
21806|NCT03281616|"~     Background: Life-style interventions are indicated in patients with metabolic syndrome and/or~     type 2 diabetes. However, cultural differences are substantial confounders to not only~     compliance, but also whether or not the interventions are offered in the first place. In~     Germany, the large Turkish-background minority has a particularly high incidence of type 2~     diabetes, but there is no recorded evidence of a life-style intervention in this patient~     group.~      Objective: The investigators tested the body weight-reducing effect of a 30% calorie-reduced~     diet, adjusted to individual eating habits and preferences regarding quality and resources of~     food in a Turkish-background cohort.~   "
21807|NCT03281603|"~     The objective of this trial is to compare patient satisfaction and retention of complete~     denture manufactured by three different techniques: CAD/CAM milling, CAD/CAM 3D printing and~     conventional technique.~   "
21808|NCT03281590|"~     This is a single institutional registry database for the patients with stroke and~     cerebrovascular diseases. Stroke is the fifth leading cause of death in the United States.~     Despite extensive research, most of the patients die or suffer from varying degree of~     post-stroke disabilities due to neurologic deficits. This registry aims to understand the~     disease and examine the disease dynamics in the local community.~   "
21809|NCT03281577|"~     The purpose of this study is to evaluate the dose-dependent effects of TAK-954 on gastric~     emptying time of solids in participants with diabetic or idiopathic gastroparesis assessed by~     scintigraphy.~   "
21810|NCT03281564|"~     A lot of patients seem to complain after hysteroscopic tubal occlusion by Essure® device with~     a worce quality of life. Investigators' hypothesis is that Essure® laparoscopic removal may~     improve quality of life. This prospectice study aim to assess the quality of life 1, 3, 6 and~     12 months after Essure® removal.~   "
21811|NCT03281551|"~     The major aim of this research is to assess the feasibility, safety and effectiveness of CD19~     CAR-T Cell Therapy for Relapsed/ Refractory Acute Lymphoblastic Leukemia/ B cell Lymphoma~     patients who have applied it.~   "
21812|NCT03281538|"~     This is an open-label multicenter, long-term extension safety study to evaluate the safety of~     IV CR845 administered after each dialysis session over a Treatment Period of up to 52 weeks.~   "
21813|NCT03281525|"~     The SQ_Heart has been designed as an observational study that evaluates the difference in~     sleep quality between 11 patients with VAD (Ventricular Assisted Device) and 98~     Cardiotransplant patients.~   "
21815|NCT03281499|"~     The purpose of this study is to evaluate the use of Transoral Robotic Surgery (TORS) to~     identify small oropharyngeal carcinomas. Findings from this study will be used to better~     determine which patients may be suitable for more targeted radiotherapy that would lead to a~     reduction in the total amount of radiotherapy needed as part of their treatment. Reducing the~     amount of radiotherapy received has been found to reduce the risk of late complications and~     toxicity to the patient.The pathologic findings will then be used to determine patients who~     may be candidates for de-intensification of radiotherapy.~   "
21816|NCT03281486|"~     An increased incidence of dental caries in association with poorly controlled diabetes has~     also been reported, Xerostomia (dry mouth) has been reported to be a common complaint of~     patients with diabetes, Without adequate saliva production, both hard and soft tissues of the~     mouth can be severely damaged and become more susceptible to infections. This 9 week,~     cross-over group, randomized, single center, study will evaluate the efficacy of HA~     formulation in alleviating dry mouth in type 2 diabetic patients.~   "
21817|NCT03281473|"~     This study aims at assessing the short-term physiological effects of 2 positive end~     expiratory pressure titration strategies in patients with ARDS.~   "
21818|NCT03281460|"~     Laparoscopic mini-invasive surgery supplanted laparotomy for many years, including~     hysterectomy or myomectomy (less postoperative complications compared to laparotomy) However~     the US Federal Drug Administration (FDA) strongly warned against the use of power~     morcellation in 2014 because of the risk of iatrogenic spread of malignant cells.~      The hypothesis is that in-bag morcellation may prevent cells dissemination. The investigator~     compare in this prospective randomized study two groups of patients: group A (in~     bag-morcellation during laparoscopic myomectomy or hysterectomy) versus group B (morcellation~     without any bag during laparoscopic myomectomy or hysterectomy)~   "
21819|NCT03281447|"~     In western countries, the number of cancer survivors increases, and current cancer care seems~     insufficient with both patients' experiences of lack of help in transitions and up to 60 % of~     the patients having psychological problems after treatment. Further, Denmark shall have new~     hospitals, where researchers and healthcare professionals are expected to merge tasks and~     reach a higher patient experienced quality of care, without additional costs, so a better way~     to provide cancer care, which benefits the patients and supports the ideas within the new~     hospitals in Denmark, is needed.~      In a randomized controlled trial, the organizational structure of the healthcare system is~     challenged and the impact of a coherent nurse navigation practice compared to the currently~     existing department-specific care coordination is tested. The primary data are changes in~     patients' self-reported cancer-related self-efficacy from inclusion till one week after~     receipt of the information that they have reached the end of treatment, or in case of~     prolonged treatment, till not later than one year after inclusion.~      Patients can participate if they are 18 years of age or older, speak and understand Danish,~     and have a proven lesion suspected of cancer in the colon or rectum after colonoscopy or~     sigmoidoscopy at the Danish endoscopy centers at Odense University Hospital (the cities:~     Nyborg, Svendborg and Odense) or at Slagelse Hospital. Furthermore, participants must not be~     mentally retarded, they must not suffer from a constant life-threatening disease, and they~     must not suffer from, or be in the diagnostic phase of, dementia or severe psychiatric~     disease.~      Participants are allocated to support from nurse navigation or to current care coordination,~     and fill in four questionnaires during their cancer trajectory: 1) At inclusion, 2) Three~     days before treatment start, 3) One week after receipt of information about treatment end or~     not later than one year after inclusion, and 4) Six weeks after measure point 3. Data is~     analyzed using suitable statistical models.~      With positive results, participants in nurse navigation are better helped during their cancer~     trajectory and have a better psychological start on the rest of their lives after cancer~     treatment. Focus will be on colon and rectum cancer care, but the results will be~     transferable to similar settings. Furthermore, positive results will support changes in the~     onset of rehabilitation initiatives.~   "
21820|NCT03281434|"~     With aging there is a natural loss of muscle mass and strength called sarcopenia, which~     increases the risk of falls and metabolic disease (i.e. Type II diabetes) and decreases the~     ability to perform activities of daily living. Eating protein and doing resistance exercise~     both increase the body's ability to make muscle protein, which is important to offset losses~     in muscle mass; however, older adults have a lower appetite and do not consume enough~     calories or protein to crease muscle and as such investigations in this population are~     needed. The amino acid (the building blocks of proteins) leucine is known to increase the~     ability of protein to make muscle. In this study we will investigate the ability of beverages~     with different types of protein and leucine to create muscle in older men and women whoa re~     particularly vulnerable to muscle losses and do not eat enough protein and are understudied~     in this area.~   "
21821|NCT03281421|"~     Anterior Knee Pain or Patellofemoral Pain (PFP) is one of the most common disorders that~     affecting knee in the physically active population, being a condition that typically presents~     as diffuse knee pain in the anterior region and retro- or peri-patellar area, mainly in~     activities that increase compression force in patellofemoral joint, such as squatting,~     running, stair ascent and descent. The overall prevalence of PFP has been reported as between~     15-45% of the population, and its incidence is higher among women. The literature cites as~     etiology of PFP the ocorrence of dysfunctions in the local (knee), proximal (trunk, pelvis~     and hip complex) and distal (ankle and foot regions) factores. Actually, there is a lack of~     studies that investigate the interventions influences on distal factors in outcomes clinical~     in persons with PFP. Thus, the aim of this study is analyze the effect of ankle mobilization~     techiniques in ankle dorsiflexion range of motion closed kinetic chain in women with~     patellofemoral pain and with dorsoflexion restriction.~   "
21822|NCT03281408|"~     Obstructive Sleep Apnea (OSA) is a common and under-diagnosed breathing disorder~     characterized by recurrent partial or complete collapse of the upper airway (tongue, soft~     palate) during sleep. It causes recurrent episodes of asphyxia (suffocation) resulting in~     fragmented sleep, low blood oxygen levels (hypoxemia), and high carbon dioxide~     concentrations. Untreated OSA is associated with serious heart/lung and metabolic diseases~     including strokes, diabetes, and heart attacks.~      When a patient with OSA undergoes surgery, the symptoms of OSA are exacerbated afterwards due~     to the effects of anesthesia and related medications such as those used for pain control.~     This put patients at higher risk for complications and necessitates nursing care and~     monitoring that are resource intensive. In many hospitals, patients with an OSA diagnosis are~     monitored after surgery in high acuity wards where the nurse to patient ratio is higher~     than usual. These high acuity/monitored beds are often in high demand, and their~     unavailability may sometimes mean cancellation of surgery or prolonged patient stay in the~     Post-operative Recovery Room, further causing operating room backlog.~      Another serious issue is that many patients do not know they actually have the OSA condition.~     It is estimated that up to 20% (1) of people in the general public have OSA and that 75% (2)~     of them are not diagnosed. When someone with OSA goes for surgery without previously being~     diagnosed, special precautions in care and monitoring may not be in place, until a~     complication develops. For this reason, this population - those most susceptible to have OSA,~     but with no previous formal testing for the condition - is the most at risk for~     complications, and is the main target group for this trial. We plan to identify the study~     population by screening for OSA using the STOP-BANG questionnaire. Those who score high on~     this 8 item screening test have high likelihood of actually having OSA if they were to~     undergo formal testing and diagnosis in a Sleep Lab.~   "
21930|NCT03279978|"~     Phase Ib evaluation of the safety, tolerability, Pharmacokinetics (PK), and Pharmacodynamics~     (PD) properties of Multiple Rising Dose (MRD) administration of BI 730357 to healthy~     volunteers for up to 28 days.~   "
21823|NCT03281395|"~     Rapid ventricular pacing (RVP) is a technique to obtain flow arrest for short periods of time~     during dissection or rupture of the aneurysm. RVP results in an adequate fall of blood~     pressure which presents as an on-off phenomenon. It is not clear whether repetitive periods~     of pacing are harmless for the patient. Silent cardiac and cerebral infarcts may be~     undetected. The investigator will study the safety of RVP, particularly for the heart and the~     brain, retrograde by studying troponin levels and magnetic resonance imaging or computed~     tomography.~   "
21824|NCT03281382|"~     This phase 1 trial will investigate the toxicity of combining interleukin 12 gene therapy~     with standard chemotherapy in metastatic pancreatic cancer.~   "
21825|NCT03281369|"~     A Phase Ib/II, open label, multi-center, randomized study designed to assess the safety,~     tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based~     treatment combinations in patients with locally advanced unresectable or metastatic G/GEJ~     cancer (hereafter referred to as gastric cancer). Two cohorts will be enrolled in parallel in~     this study: the second-line (2L) Cohort will consist of patients with gastric cancer who have~     progressed after receiving a platinum-containing or fluoropyrimide-containing chemotherapy~     regimen in the first-line setting, and the first-line (1L) Cohort will consist of patients~     with gastric cancer who have not received prior chemotherapy in this setting. In each cohort,~     eligible patients will be assigned to one of several treatment arms.~   "
21826|NCT03281356|"~     This pilot study aims to assess the acceptability, feasibility, and preliminary effectiveness~     of text messages designed to encourage shared reading among urban parents. We hypothesize~     that parents will report reading more often to their children after receiving the text~     messages.~   "
21827|NCT03281343|"~     Pre-exposure prophylaxis (PrEP) can be very effective at preventing HIV infection among women~     at high-risk for HIV but is underused in this population. Periods of incarceration represent~     an opportunity to identify women at risk and link them to PrEP care as they leave jail or~     prison. This study aims to improve linkage to community-based PrEP care to reduce HIV~     acquisition in a high-need, underserved community.~   "
21828|NCT03281330|"~     The study investigates the effect of different conditions of auditory cueing and music on~     walking quality and perceived fatigue in persons with multiple sclerosis compared to healthy~     controls. The study extends over a four session period, each session lasting maximally 1h30~     minutes The experimental conditions include participants walking to music and metronome (at~     different tempi) for 3minutes and 15 seconds per condition, with a rest period of 3 minutes~     in between each condition. Non-invasive equipment will be used. participants are equipped~     with sensors (watch-like straps at the wrists, ankles and across the chest) and are given~     wireless headphones.~   "
21829|NCT03281317|"~     Vasoplasmic syndrome in cardiac surgery is one of the major postoperative complications.This~     syndrome is characterized by persistent low blood pressure despite an optimization of preload~     and inotropism.~   "
21830|NCT03281304|"~     This study is a follow up study for subjects with Ulcerative Colitis (UC) in stable remission~     designed to evaluate flexible dosing of CP-690,550.~   "
21831|NCT03281291|"~     The goal of the proposed amplicon sequencing and genotyping study is to assess vaccine~     efficacy against clinical and asymptomatic malaria infection using ultra-sensitive molecular~     amplification and sequencing methodology to detect Plasmodium falciparum (P. falciparum)~     parasites from serial blood samples to be collected from children immunized with the primary~     and yearly booster immunizations of the RTS,S/AS01E vaccine as part of their participation in~     Protocol MALARIA-094 (parent clinical study protocol). Genomic analysis will be performed on~     parasites from blood spot samples collected from children aged 5 17 months immunized with~     RTS,S/AS01E on different dosage and schedule regimens under the parent clinical study~     protocol.~   "
21832|NCT03281278|"~     Ineffective hemostasis or a paradoxical prothrombotic state of Acute-on-chronic liver disease~     (ACLF) has been well established. Thrombelastography measures the dynamics of thrombin~     production and provides a global assessment of coagulation incorporating the cumulative~     effect of the interactions at various levels between plasma components and cellular component~     of coagulation. And through the platelet mapping, it can help provide a picture of patients'~     function of platelet. This study aims to explore the predictive role of platelet mapping in~     ACLF prognosis, organ failure developments and short term mortality.~   "
21833|NCT03281265|"~     The definition and diagnostic criteria of Acute-on-chronic liver failure (ACLF) has been well~     established by EASL CANONIC study. However, patients with high risk to develop ACLF has not~     been determined, yet. The aim of current study is to establish a preliminary pre-ACLF~     definition, and to demonstrate the corresponding risk factors.~   "
21834|NCT03281252|"~     Ineffective hemostasis or a paradoxical prothrombotic state of Acute-on-chronic liver disease~     (ACLF) has been well established. However, the minor and major bleeding events has not been~     described yet. We observe the patients' major and minor bleeding events and use 4 criteria,~     which include BARC, ISTH, TIMI, Gusto ,to evaluate the incident rate of bleeding events in~     ACLF patients and pre-ACLF patients.~   "
21835|NCT03281239|"~     Metals and oxydes are found in welding fumes and are thought to participate in increasing~     cardiovascular risk in exposed workers. Investigators aimed to evaluate the impact of this~     occupational exposure on cardiovascular system in a highly exposed population, ship repairing~     welders and to compare this population to paired controls.~   "
21855|NCT03280979|"~     Gestational trophoblastic neoplasia (GTN) are malignant lesions that arise from abnormal~     proliferation of placental trophoblast. The pathologic conditions that make up this entity~     include invasive partial and complete hydatidiform mole, choriocarcinoma, placental site~     trophoblastic tumor (PSTT), and epithelioid trophoblastic tumor (ETT). GTN often arises after~     molar pregnancies but can also occur after any gestation including miscarriages and term~     pregnancies. In the United States, hydatidiform moles are observed in approximately 1/600~     therapeutic abortions and 1/1000-2000 pregnancies . Most cases of GTN are diagnosed when the~     serum hCG levels plateau or rise in patients being observed after the diagnosis of~     hydatidiform mole.These malignancies are highly susceptible to chemotherapy and it is often~     possible to achieve cure while preserving the woman's reproductive function~   "
21950|NCT03279705|"~     This prospective randomized controlled trial compared integrated water jet channel~     colonoscopy with traditional accessory channel colonoscopy in cecal insertion time among~     patients undergoing WE method colonoscopy.~   "
21836|NCT03281226|"~     Although tuberculosis is a treatable disease, it is currently the infectious disease with the~     highest mortality in the world. It is estimated that one-third of the world's population is~     infected. HIV is the main predisposing factor for TB development. The Brazilian Ministry of~     Health and the World Health Organization recommends that patients should initially be treated~     orally with RIPE - rifampicin (R), isoniazid (I), pyrazinamide (P) and ethambutol (E). The~     N-acetylcysteine (NAC) first benefit was reported during the 1960s, when it proved to be an~     effective mucolytic agent in individuals with cystic fibrosis. Later, a new role arose when~     investigating its therapeutic potential in acetaminophen intoxication. Cleavage of the acetyl~     group makes cysteine available for later incorporation into glutathione synthesis, decreased~     in hepatic injury caused by acetaminophen. This mechanism causes NAC to have an indirect~     antioxidant effect, which aroused an interest in studying the effect in diseases that occur~     with oxidative stress. TB and HIV/Aids are also diseases with chronic inflammation. The~     present study aims to evaluate the effects of NAC as a adjuvant therapy in the treatment of~     TB. This is a phase II randomized clinical trial in which the safety and tolerability of NAC~     as adjunctive therapy for TB treatment will be assessed. Fifty-six patients will be~     randomized into two groups. The first group will receive the standard tuberculosis treatment~     as recommended by the Brazilian Ministry of Health (RIPE); the second will receive in~     addition to this treatment 1200mg of NAC per day for two months. In this way, microscopy and~     culture conversion rate to mycobacteria at 8 weeks, levels of glutathione and biomarkers of~     immune activation and inflammation in case of TB with or without NAC will be monitored.~   "
21837|NCT03281213|"~     Adequate analgesia in thoracic surgery is essential to prevent severe postoperative~     complications, especially respiratory problems. Current knowledge about gender-related~     differences in pain states generally more frequent and intense pain and more demand for~     analgesics in women. Results about postsurgical pain in particular are very inconclusive.~      The investigators tried to find out if gender has an influence on postthoracotomy pain and~     analgesics requirement.~   "
21838|NCT03281200|"~     The present study has been designed to characterize IPF patients treated with nintedanib~     (OFEV®), at time of treatment initiation, with respect to their clinical profile based on~     real-world data from January 2016 in Spanish Pulmonology Services.~   "
21839|NCT03281187|"~     This is a phase III study for evaluation of Nasotestt efficacy compared to Androgel in the~     treatment of male participants with hypogonadism condition (reduced levels of testosterone)~     that have clinical indication of hormonal replacement with testosterone.~   "
21840|NCT03281174|"~     The purpose of this study is to evaluate the 5-year Immune Persistence of Inactivated~     Enterovirus Type 71 (EV71) Vaccine manufactured by Sinovac (Beijing) Biotech Co., Ltd.~   "
21841|NCT03281161|"~     Sun Safe Workplaces (SSW), a comprehensive occupational sun safety program, promoted~     education and policy to 98 cities, counties, and special districts in Colorado. In a two-year~     follow-up study, Klein Buendel, Inc. (KB) proposes to examine the effectiveness of SSW on~     employee sun protection practices by employers and return on investment in an economic~     evaluation of the cost of the SSW intervention. The results of this follow-up study will~     provide critical information on effective approaches to increasing sun protection across a~     wide range of employment sectors with outdoor workers.~   "
21842|NCT03281148|"~     Patients with hopeless teeth in the esthetic area requiring immediate implant restoration~     will be recruited to the study. Patients will be divided into two groups; a group will~     receive immediate implants placed using CAD/CAM guides while the other group will receive~     immediate implants placed by free hand technique. Accuracy of inserted implants will be~     measured.~   "
21843|NCT03281135|"~     This project aims to optimize cervical cancer screening adherence comparing Arm A (VIA) and~     Arm B self-sampled Human Papilloma Virus (HPV) testing and determine the molecular~     epidemiology of HPV, persistence level and identify factors responsible for persistence, and~     also characterizing the potential dysplasia by biomarkers that describe the disease stage in~     a population of Ethiopia.~      A cluster-randomized trial will be used in this study. The total number of ten~     kebele's(Smallest administrative unit) will be randomly classified in to two arms(VIA and~     HPV+VIA).Community health workers will be used as a cluster for randomization. Community~     sensitization and awareness creation will be performed at health facilities and in~     communities at social, business or religious gatherings, about cervical cancer and its~     prevention for eligible women in both arms. Women will be educated about cervical cancer and~     advice for testing at the Hospital offering VIA (arm A). Women will also be instructed to~     undergo HPV self-sampling at nearby health posts with a vaginal evalyn brush (arm B). All~     eligible women on each cluster will be included in the study at both arms. Based on the~     community health workers number and structure study area there will be about 22 clusters with~     80 eligible women on each cluster. Brushes will be sent to the Microbiology Laboratory of~     Department of Microbiology,Immunology and Parasitology,College of Health Sciences, Addis~     Ababa University, Addis Ababa, where the laboratory service is sated-up . Trained~     Microbiologists will perform the laboratory analysis at the HPV laboratory. Only women with~     samples positive for high-risk HPV (hrHPV) will be contacted and informed to go to the~     Hospital offering VIA. Further tests will also be performed from the brushes at the~     collaborators' HPV laboratory, Germany to better characterize the dysplesia.~      The women found positive for VIA or hrHPV+VIA will receive cryo treatment at Butajira~     Hospital. To evaluate the long-term effect and factors for persistence, all eligible women~     within the catchment area will be visited after 2 years door to-door and asked for a vaginal~     self-sample and HPV-genotype test. The impact of intervention, factors associated with HPV~     infection, persistence, clearance, and adherence to the screening service will be seen.~   "
21844|NCT03281122|"~     The purpose of this study is test the safety and tolerability of BMS-986224 and its effects~     on the body in healthy subjects and subjects with chronic heart failure with reduced ejection~     fraction~   "
21845|NCT03281109|"~     Aim: Women's menstrual cycle is controlled by the secretion of sex hormones. Sex steroid~     hormones are thought to be affect to periodontal tissues, wound healing, periodontal disease~     progression and bone turn over. The aim the study is to evaluate clinical periodontal~     parameters and interleukin- 6 (IL-6) and tumor necrosis factor alpha (TNF-α) levels in~     gingival crevicular fluid (GCF) in menstrual cycle.~      Material and methods: Twenty-five patients were included in this study clinical periodontal~     parameters and levels of IL-6 and TNF α in gingival crevicular fluid were evaluated at three~     periods of menstrual cycle (menstruation day (MD)-ovulation day(OD)-premenstruation day~     (PmD)). Levels of IL-6 and TNF α in gingival crevicular fluid were determined by ELISA.~   "
21846|NCT03281096|"~     Experimental studies in animals and observational studies in humans suggest that~     fusobacterium nucleatum is associates with stages of colorectal neoplasia development, and~     Berberine Hydrochloride could rescue Fusobacterium nucleatum-induced colorectal tumorigenesis~     by modulating the tumor microenvironment. Whether regular Berberine Hydrochloride use may~     decrease the risk of colorectal adenomas, the precursors to most colorectal cancers is worth~     to further study.~   "
21951|NCT03279692|"~     This research study is studying a drug as a possible treatment for High Grade Meningioma.~      The drug involved in this study is an immunotherapy drug called pembrolizumab~   "
21847|NCT03281083|"~     Background: Non-alcoholic fatty liver disease (NAFLD) is a spectrum of disorders~     characterized by lipid accumulation in hepatocytes. Evidence shows that thyroid hormone might~     be beneficial for this condition.~      Objective: To determine whether low dose levothyroxine (LT4) therapy may be a potential~     treatment for diabetic patients with NAFLD in a single arm study.~      Primary: To ascertain whether administration of LT4 for 16 weeks by titrating the serum~     thyroid stimulating hormone (TSH) to 0.34 mIU/L - 1.7 mIU /L reduces liver fat content by at~     least 3% among patients with type II diabetes as measured by functional MRI.~      Secondary: To ascertain whether administration of LT4 for 16 weeks by titrating the serum TSH~     to 0.34 mIU/L - 1.7 mIU /L can improve glycemic control as measured by reduction in~     glycosylated hemoglobin (HbA1c), improve serum lipid profile in Type II diabetic patients~     with NAFLD as measured by total serum cholesterol, high-density lipoprotein (HDL),~     low-density lipoprotein (LDL) and total triglycerides (TG) and reduce the proportion of liver~     fat over body fat, which is reflected by fat in abdominal subcutaneous and visceral tissues,~     as measured by functional MRI on abdomen.~      Subjects and Centres: A total of 50 eligible adult diabetic men with NAFLD will be recruited~     from 6 centres in Singapore - Changi General Hospital (CGH), Singapore General Hospital~     (SGH), Tan Tock Seng Hospital (TTSH), National University Health System (NUHS), Khoo Teck~     Puat Hospital (KTPH), Jurong Health (JH)~      Eligible patients: Males between 21 to 60 years of age diagnosed with stable Type II diabetes~     mellitus (DM) with a baseline alanine aminotransferase (ALT) < 3 times upper limit of normal~     as per the institution's specified reference range, with a liver ultrasound (US) showing~     presence of fatty liver and baseline Thyroid stimulating hormone (TSH) levels between 1 - 10~     mIU/L.~      Treatment: Low dose levothyroxine (LT4) for 16 weeks, not including the 12 weeks of pre-study~     titration of LT4 in order to attain target TSH level of 0.34-1.70 mIU/L.~      Statistical Analysis: The absolute change in liver fat content from baseline (primary~     endpoint) will be analyzed using one-sample two-sided t-test at a 5% significance level. The~     same test will be applied to secondary endpoints. Mean, standard deviation and 95% confidence~     interval will be calculated for primary endpoint and secondary endpoints.~   "
21848|NCT03281070|"~     Anastomotic leakage (AL) is one of the most-feared postoperative complications after anterior~     resection of rectal cancer. This complication compromises both short term and long term~     outcome of patients. The incidence of AL after anterior resection was approximately 6-11%.~     Although several risk factors for AL such as male sex, smoking, tumor location, longer~     operative time, intraoperative blood loss had been reported in previous studies, the~     incidence of AL did not meet a significant decrease. So far there is no multi-site~     observational study on incidence and risk factors of AL after anterior resection in China,~     therefore this study aims to work on this issue and provide evidence for clinical practice.~   "
21849|NCT03281057|"~     The present study is dedicated to empowering individuals close to an addicted person (i.e.~     concerned significant others, CSOs) to create changes in their family environment: changes~     that increase the likelihood of the addicted person seeking treatment.~      The Danish National Clinical Guideline for the treatment of alcohol dependence recommends~     that alcohol treatment centers offer interventions aimed at CSOs, providing them with the~     support and empowerment that will enable them to motivate the problem drinker to enter~     treatment. In the US, the Community Reinforcement and Family Training (CRAFT) intervention~     has been shown to offer the most effective support to CSOs. CRAFT has consistently~     demonstrated a two to three times' higher impact on getting individual with an alcohol use~     disorder (AUD) to attend treatment, compared to other kinds of interventions. Studies of the~     intervention so far have, however, been small, and the format used in the delivery of CRAFT~     has not been fully investigated.~      The aim of the present cluster randomized controlled trial is to implement and investigate~     CRAFT in a Danish context and with sufficient sample size. Consecutive CSOs will through~     cluster randomization be randomized to receive either CRAFT in a group format, CRAFT in an~     individual format, or a control condition, consisting of self-help material only. The primary~     outcome of the study will be the rate of individuals with AUD entering treatment following~     the intervention targeted at the CSOs within three months from its initiation. Data will be~     collected from all CSOs at baseline, three, and six months after baseline.~   "
21850|NCT03281044|"~     The prevalence of psychiatric disorders such as major depression disorder (MDD) is increasing~     rapidly. Despite advancements in the development of therapeutics, current treatment options~     have not reached optimal efficacy.~      Recent interest has been drawn towards the importance of the biochemical signalling between~     the gastrointestinal tract and the central nervous system also known as the~     microbiome-gut-brain axis. The pathogenesis of gut microbiota in extra intestinal diseases~     was inspired by massive studies in germ free (GF) animals, which indicated that the gut~     microbiota plays a role in the normal regulation of behaviour that are relevant to mood,~     anxiety and stress. However, the exact mechanisms by which intestinal dysbiosis are involved~     in the development of psychiatric diseases are not completely clarified.~      A new method to alter the composition of the gastrointestinal microbiota involves fecal~     microbiota transplantation (FMT). The goal of FMT is to introduce or restore a stable~     microbial community in the gut by transplanting intestinal microbiota from a healthy donor to~     the patient. FMT, as a microbiota-target therapy, is arguably very effective for curing~     recurrent Clostridium difficile infection and has good outcomes in other intestinal diseases.~     At the same time, applications in previously unexpected areas, including metabolic diseases,~     neuropsychiatric disorders, autoimmune diseases, allergic disorders, and tumors have shown~     health enhancing results. FMT has initially been conducted using colonoscopy. However, recent~     evidence has shown that treatment with frozen FMT capsules (to be taken orally) is also safe~     and beneficial in restoring the gut microbiota in patients with various diseases As FMT~     capsules may be an effective, pragmatical adjuvant therapy (in addition to standard~     treatment) for depression, this project is aimed at (1) investigating for the first time if~     single administration of FMT capsules ameliorates depressive symptoms in patients with~     moderate to severe MDD 4 weeks after treatment and (2) establishing the safety profile of~     encapsulated FMT in MDD. Furthermore, we will also test if (3) FMT capsules modulates immune~     signalling and inflammatory processes, (4) Hypothalamic-pituitary-adrenal (HPA) axis~     responses, (5) neurogenesis, (6) energy balance hormones, (7) gut microbiota composition and~     (8) brain perfusion, structure and activation.~   "
21851|NCT03281031|"~     Objective :~      To demonstrate diagnostic performances of Magnetic Resonance Imaging (MRI) as compared to~     Computed Tomography (CT) as a second intention imaging modality in young women with acute non~     traumatic abdominopelvic pain and non contributive ultrasonography.~   "
21852|NCT03281018|"~     The research hypotheses that preoperative formal hypnosis session reduces perioperative~     anxiety among women undergoing a hysterectomy for pelvic gynecological cancer. The key~     objective is to estimate the effect of preoperative hypnosis on preoperative anxiety among~     this population~   "
21853|NCT03281005|"~     The objective of this study is to develop the comprehensive visual function evaluation method~     in severe visually impaired patient~   "
21854|NCT03280992|"~     The aim of this project is to constitute a prospective cohort of all the patients presenting~     to the adult emergencies of the University Hospital Centre (CHU) of Rennes for a septic~     syndrome of community origin.~   "
21856|NCT03280953|"~     Pulse wave Transit time (PWTT) is a parameter calculated from ECG and pulseoximeter. It is~     supposed to help assessing the preload Status and guide intraoperative fluid therapy. This~     Project aims to validate the benefit of PWTT assessment in an observational clinical fluid~     study. In case of hypovolemia, patients will receive a fluid Bolus and hemodynamic data from~     clinical Standard Monitoring, esophageal doppler and PWTT will be recorded before and after~     the fluid Bolus. Receiver operating characteristic (ROC) curve will be used to determine the~     validity of PWTT as indicator for fluid responsiveness and its cut off value.~   "
21857|NCT03280940|"~     Low viral replication persistence and immune activation remain important therapeutic~     challenge in the new HAART era. They are associated with more rapid disease progression,~     increased risk of mortality and non-AIDS defining events. Soluble biomarkers are a convenient~     way of assessing immune activation and inﬂammation in HIV-infected patients receiving~     effective treatment. There are limited data describing the different effects of currently~     recommended antiretroviral regimens on immune activation and inﬂammation during HIV~     infection. Several studies have shown that raltegravir (the first approved drug from~     integrase inhibitor class) seems to have more impact on decreasing systemic inflammation~     compared with other drug classes. Integrase inhibitors may decrease inflammation and immune~     activation more than other antiretroviral drugs, because they are more lipid friendly and may~     concentrate better in enterocytes. The aim of this observational study is to compare the~     impact of different integrase inhibitor based regimen on changes in markers of inflammation~     (Il-2, IL-6, sTNFR-1, sCD14, sCD163, sICAM, hsRCP , sVCAM, LPS, D-dimer) during the first~     year of effective first-line combination. This is a 48-week observational retrospective~     study, to compare the change in infiammatory markers between naïve patients who start INI~     based regimen. Participants will be recruited from the HIV outpatient clinic. The study~     compare the impact of commonly used first-line antiretroviral drugs on soluble markers of~     inflammation and immune activation. The study is conducted on treatment-naive HIV-infected~     patients who experience a rapid and persistent virological response and that do not switch~     their initial regimen for at least 1 years. The analyses will be adjusted for baseline~     characteristics that might influence the choice of cART regimen or affect biomarker levels,~     such as age, smoking status, CD4 cell count, plasma HIV-1 viral load. Investigators enroll~     patients with a rapid and persistent virological response and that do not experience any~     blips. Cryopreserved plasma sample are obtained at baseline and at month 6 and 12 after~     treatment starting. Two NRTI backbone combinations (TDF/FTC vs ABC/3TC) and three third~     agents (RAL vs ELV vs DTG) will be compared in a factorial design. The results will be~     expressed as the estimated percentage difference between the mean fold changes observed with~     a given drug, using TDF/FTC and RAL as the reference groups for the comparison.~   "
21858|NCT03280927|"~     The antifungal efficacy and safety of Jublia® topical solution will be assessed through an~     administration for 48 weeks to patients diagnosed with a mild or moderate onychomycosis due~     to dermatophyte.~   "
21859|NCT03280914|"~     This observational study in a real-world community was designed to perform epidemiological~     investigation and assess effect of CPAP intervention of obstructive sleep apnea.~   "
21860|NCT03280901|"~     The purpose of this study is to characterise in detail cardiac, cerebral and renal structure,~     function and perfusion in patients on haemodialysis (HD) using magnetic imaging techniques.~     The effects of a standard prescription haemodialysis (dialysate temperature 37 C) will be~     compared to a thermocontrolled (or isothermic) haemodialysis prescription to ascertain if~     thermocontrolled HD provides a protective effect on organ perfusion and circulatory stress~     when compared to conventional haemodialysis. The BTM (blood temperature monitor, Fresenius)~     offers a way to overcome this to regulate thermal balance during dialysis and achieve a~     neutral thermal balance (isothermic) over the dialysis session. Other dialysis parameters~     will be standardised between treatment arms using blood volume monitoring (BVM) and clinical~     assessments.~   "
21861|NCT03280888|"~     Chronic Myelomonocytic Leukemia (CMML) is the most frequent of~     myelodysplastic/myeloproliferative syndromes, as defined by the WHO classification of myeloid~     malignancies. The median age at diagnosis is around 70 years with a strong male predominance.~     CMML is a clonal disease of the bone marrow hematopoietic stem cell mainly characterized by~     persistent monocytosis (>1x109/L) and the presence of immature dysplastic granulocytes in the~     peripheral blood of CMML patients. Allogeneic stem cell transplantation (ASCT) remains the~     only curative option in CMML. However, CMML patients are rarely eligible for this kind of~     therapy, mainly due to their advanced age. The gold standard treatment of CMML thus remains~     hydroxyurea, which is usually initiated when the disease becomes proliferative, and~     demethylating agents, which could be efficient in the most aggressive forms of CMML.~     Nevertheless, the pathogenesis of CMML remains poorly understood and new therapies are~     urgently needed for patients in treatment failure.~      In recent years, a large numbers of gene mutations have been discovered in CMML, none of~     which are specific of this entity, as they can be encountered with different frequencies in~     other myeloid neoplasms. These mutated genes encode signaling molecules (NRAS, KRAS, CBL,~     JAK2, FLT3 and several members of the Notch pathway), epigenetic regulators (TET2, ASXL1,~     EZH2, IDH1, IDH2,.) and splicing factors (SF3B1, SRSF2, ZRSF2). Mutations in the~     transcription regulators RUNX1, NPM1 and TP53 have also been reported in CMML. However, the~     role of these mutations in leukemogenesis is still unclear. CMML is also characterized by~     defects in monocyte to macrophage differentiation. These defects in monocyte differentiation~     can be attributed to the presence of immature dysplastic granulocytes that secrete high~     levels of alpha-defensins HNP1-3 that antagonize the purinergic receptor P2RY6 in CMML~     patients. These CD14-/CD15+/CD24+ immature granulocytes that belong to the same clone than~     the leukemic monocytes seem to have immunosuppressive properties ressembling those of the~     myeloid-derived suppressor cells (MDCS) described in solid tumours. Whether these immature~     granulocytes contribute to autoimmune manifestations or immunoescape and progression of CMML~     is a conendrum and remains to be determined.~      In this context, the proposed project aims at identifying news insights into the~     pathophysiology of CMML through a better definition of the phenotype and function of~     monocytes and immature granulocytes that characterize this pathology.~   "
21862|NCT03280875|"~     The aim of the EXO-MODE project is to develop an innovative algorithm for the personalisation~     of Concentric and / or Eccentric training programmes adapted to the individual to improve the~     efficiency and tolerance. This algorithm will make it possible to personalise trainings~     programmes according to the different profiles of subjects, determined on the basis of their~     personal characteristics (age, sex, comorbidities), their exercise capacity and muscle~     performance, their level of motivation and their perception of the workload, and of the~     principal objective of the training programme. The final goal is to develop a tool to allow~     elderly populations to exercise more easily and more effectively.~   "
21863|NCT03280862|"~     Heart failure is a leading cause of morbidity and mortality. Cardiac resynchronization~     therapy (CRT) is a well-established treatment for patients with symptomatic heart failure in~     spite of optimised medical treatment (OMT), reduced left ventricular pump function with left~     ventricular ejection fraction (LVEF) ≤ 35% and prolonged activation of the ventricles (bundle~     branch block: BBB). CRT is established by implanting an advanced pacemaker system with three~     leads in the right atrium, right ventricle, and in the coronary sinus (CS) for pacing the~     left ventricle (LV), and often is combined with an implantable defibrillator (ICD) function.~     On average, CRT treatment improves longevity, quality of life and functional class, and~     reduces heart failure symptoms. Thus, at present, CRT is indicated for heart failure patients~     on OMT with BBB or chronic right ventricular (RV) pacing.~      It is, however, a significant problem that 30-40% of CRT patients do not benefit measurably -~     showing symptomatic improvement or improved cardiac pump function - from this therapy~     (socalled non-responders). LV lead placement is one of the major determinants of beneficial~     effect from CRT.~      Observational studies and three randomised trials with small sample sizes indicate that~     targeted placement of the LV lead towards a late activated segment of the LV may be~     associated with improved outcome. Based on this literature, some physicians already search~     for late activation when positioning the LV lead. However, such a strategy was never tested~     in a controlled trial with a sample size sufficient to investigate important clinical~     outcomes. Detailed mapping for a late activation may increase operating times and infection~     risk, result in use of more electrodes and wires, thereby increasing costs, and increase~     radiation exposure for patient and staff. Placement of the LV lead in late activated areas~     close to myocardial scar may even result in higher risk of arrhythmia and death.~      At present, it is completely unsettled whether targeted positioning of the LV lead to the~     latest electrically activated area of LV is superior to contemporary standard CRT with regard~     to improving prognosis for patients with heart failure and BBB.~      The present study aims to test whether targeting the placement of the LV lead towards the~     latest electrically activated segment in the coronary sinus branches improves outcome as~     compared with standard LV lead implant in a patient population with heart failure and CRT~     indication.~   "
21890|NCT03280511|"~     In this study, patients will be offered two Pressurized Intraperitoneal Aerosol Chemotherapy~     (PIPAC) treatments with oxaliplatin after primary resection and standard adjuvant~     chemotherapy (if indicated) for colon cancer. Furthermore, the study will explore, whether it~     is possible to find free intraperitoneal tumor cells (FITC) after resection and adjuvant~     chemotherapy for colon cancer.~   "
21864|NCT03280849|"~     A 65 year old female participant , right handed, started with progressive bilateral visual~     loss in her temporal field, over 10 months, the participant underwent an MRI and it was found~     a sellar lesion that compressed the optic chiasm, an endoscopic endonasal transsphenoidal~     surgery was done for the resection of the lesion, using a novel bilaminar chitosan scaffold~     to assist the closure of the sellar floor. After a follow up of 2 years the participant~     returned to its normal visual function, without evidence of the sellar lesion on the~     postoperative MRI, and without complications.~   "
21865|NCT03280836|"~     The investigators seek to conduct a home based exercise intervention in breast cancer~     patients whom elect to undergo neoadjuvant chemotherapy. The primary aim of the study is to~     determine whether breast cancer patients can be enrolled, randomized, retained, and comply~     with exercise program; and, the feasibility of acquiring, managing and analyzing clinical~     data.~   "
21866|NCT03280823|"~     Platelet units are stored and complement factors are evaluated~   "
21867|NCT03280810|"~     Beside these well-known symptoms (positive symptoms (such as delirium and delusions),~     negative symptoms (such as affective flattening and impoverishment of speech), disorganized~     behavior, patients with schizophrenia show different kinds of cognitive alterations and motor~     abnormalities. In schizophrenia, postural impairment could increase the attentional cost of~     daily motor tasks, leading to a lack of attentional resources, essential to achieve complex~     cognitive tasks. The intrication of cognitive and postural processings (both impaired in~     schizophrenia) can be explored by using of a dual-task paradigm.~   "
21868|NCT03280797|"~     This study will assess the feasibility of using cytokine expression profiles in blood samples~     as a method for evaluating rheumatoid polyarthritis~   "
21869|NCT03280784|"~     this protocol aides to evaluate:( 1)whether upper gastrointestinal endoscopy (UGE) is used~     appropriately according to the Guideline on pediatric GI endoscopy [1] commissioned by the~     European Society for Paediatric Gastroenterology Hepatology and Nutrition(ESPGHAN) and the~     European Society of Gastrointestinal Endoscopy(ESGE). In our hospital setting and(2) whether~     there is any relationship between appropriateness of gastrointestinal endoscopy and the~     presence of lesions detected by endoscopy.~   "
21870|NCT03280771|"~     The Hope Soap Study is a randomised-control pilot study of a hand-washing intervention in~     which children in treatment households received a bi-monthly delivery of HOPE SOAP©, a~     colourful, translucent bar of soap with a toy embedded in its centre.~   "
21871|NCT03280758|"~     This randomised controlled trial aims to investigate a resistance training program for~     improving glycemic control, muscle mass, strength and functional performance in older~     patients with Type II Diabetes (T2 DM).~      60 subjects will be randomly allocated to either a muscle strengthening group or a no~     exercise control group.~      Muscle strengthening group will receive resistance training 3 times per week (1~     hour/session).~      The control group will not receive any training but can continue usual medical care and daily~     activities.~      Primary outcomes: glycemic control and lipid profile Secondary outcomes: muscle mass and~     strength, and functional capacity Data will be collected at baseline (pre-test) and after a~     4-month intervention (post-test).~   "
21872|NCT03280745|"~     Background: Volume replacement strategies and type of fluid used in patients undergoing~     cardiac surgery have changed during the last years. Currently used crystalloid solutes have a~     variable composition and a major impact on organ function and outcome. Additionally~     critically ill patients are prone to fluid overload, which is despite common perception, not~     a benign occurrence as it is associated with prolonged ICU- and hospital length of stay and~     increased mortality rates. Fluid resuscitation using bolus or continuous infusion of~     hypertonic saline was used for more than thirty years. Only a few studies have been conducted~     so far, but they showed that infusion of hypertonic saline results in less volume~     administered, increased renal function less weight gain in critically ill patients when~     compared to other crystalloids.~      Aim: This preliminary randomized controlled double-blind study aims to identify whether fluid~     resuscitation using hypertonic saline (HS) when used in addition to lactated Ringers solution~     results in less total fluid amount administered in patients following cardiac surgery.~     Additionally we want to evaluate whether the use of hypertonic saline results less need for~     pharmacological cardiocirculatory support, increased renal function, less postoperative~     volume overload shortened post-cardiac bypass immune suppression and increased postoperative~     outcomes.~      Study intervention: At admission to the ICU patients will receive 5ml/kg body weight of 7.3%~     NaCl or 0.9% NaCl by infusion pump over 60 minutes. If necessary, fluid resuscitation will~     thereafter be performed with Ringer`s lactate to normalize peripheral perfusion and to allow~     weaning of vasopressors.~   "
21873|NCT03280732|"~     Bronchiolitis is the leading cause of hospitalization in infants. The diagnosis is clinical~     and chest x-ray (CXR) should be reserved for severe cases in which signs of pulmonary~     complications are present. Nevertheless, CXR is performed in more than 50% of hospitalized~     patients with bronchiolitis, which exposes infants to ionizing radiation.~      Data on the possible role of lung ultrasound (LUS) in children with bronchiolitis and~     suspected pulmonary complications have not been published yet.~      The purpose of this study is to evaluate the use of LUS compared to CXR in diagnosing and~     monitoring pulmonary complications (pneumonia, pleural effusion, pneumothorax) in children~     with acute bronchiolitis. The second purpose of the study is to evaluate the correlation~     between clinical course and ultrasound findings in children with bronchiolitis.~      The inclusion of LUS in the diagnostic work-up of bronchiolitis could possibly reduce the~     misuse of CXR in infants and the exposure to ionizing radiations.~   "
21874|NCT03280719|"~     The goal of this trial is to evaluate the effect of the prone crawl treatment position and/or~     accelerated schedule on acute and late toxicities, as well as quality of life and time~     management for breast cancer patients receiving whole breast and regional nodal irradiation~     after breast conserving surgery.~   "
21875|NCT03280706|"~     This study evaluates the gastric emptying of pregnant woman at term who received one of the~     three solutions: maltodextrin, orange juice or coffee with milk.~   "
21876|NCT03280693|"~     Body composition, bone mineral density (BMD), and body balance are important factors that~     threaten postural control. They act as vital elements in the vicious circle that leads to~     fracture occurrence in elderly population, particularly postmenopausal women.~   "
21877|NCT03280680|"~     Bangladesh has the earliest patterns of marriage in the current developing world, high~     adolescent fertility and high rates of spousal violence against women and girls. Women and~     girls are often denied the right to choice or consent with respect to marriage, sex,~     contraceptive use and childbearing. However, the denial of these rights and its consequences,~     have not been adequately recognized and addressed in the context of the existing discourse or~     interventions in Bangladesh on sexual and reproductive health or violence against women. It~     is envisaged that the focus on realizing the right to choice and consent will bring about~     change in attitudes and behaviors that could not be achieved through a single intervention.~      A multi-sectoral action research-based intervention is proposed, involving access to~     information about rights, available remedies and related referrals. Information will be~     coupled with access to legal and health services. This action research project aims to create~     a body of evidence. This multi-sectoral intervention in urban Bangladesh will highlight the~     critical element of expressing or refusing consent and choice, through a strong network~     between legal services, reproductive and sexual health service providers, human rights~     advocates, and research organizations.~      This project proposes to implement an integrated intervention with both primary preventions~     and curative components based on the findings of the formative research. This project will~     document the program implementation and impact through detailed quantitative and qualitative~     evidence gathering, and carrying out an advocacy program to disseminate the results and bring~     about change. It includes:~        -  designing culturally sensitive intervention activities with a joined up approach.~        -  a strong community mobilization campaign for creating an enabling environment for women~          to live violence free lives.~        -  individual access to reproductive and sexual health services provided through health~          clinics and legal services, with legal clinics providing information, advice and support~          access to judicial remedies for redress in cases of serious violence.~        -  broader advocacy activities involving key stakeholders to reflect upon the findings and~          understandings geneated by the study and their relevance for the administration of~          justice delivery mechanisms.~      Community engagement in the project will occur at multiple levels. At the local level the~     project will engage through community mobilisation and service delivery with adolescent~     girls, women and men living in urban slums of Dhaka city. It will also undertake targeted~     advocacy programmes with the frontlines of the justice delivery system relevant to these~     areas. Finally, it will engage at a national level with policymakers, researchers and key~     stakeholders in the justice system and health through its advocacy related interventions,~     drawing directly upon its findings.~   "
21878|NCT03280667|"~     This Single-arm, multicentre, phase 2 trial aims determine the activity and safety of~     pembrolizumab and denosumab in advanced clear cell renal cell carcinoma (ccRCC).~   "
21879|NCT03280654|"~     In present study, we aimed to investigate the association between visceral adiposity index~     and overactive bladder symptoms in female patients aged over 18 years.Between January-2015~     and July-2017, 151 female patient with overactive bladder symptoms were evaluated in Recep~     Tayyip Erdogan University Training and Research Hospital Urology Department. Antropometric~     and laboratory features including serum lipid levels, AST, ALT, fasting glucose levels, and~     also urodynamic findings were recorded. Visceral adiposity index was calculated according to~     gender-specific formula. Participants were divided into two groups according to 7,55 cut-off~     level for visceral adiposity index levels. Statistical significance were discussed between~     two groups.~   "
21880|NCT03280641|"~     This is a sigle-center, prospective study to evaluate the role of D-Dimer testing in patients~     with atrial fibrillation receiving Dabigatran or warfarin anticoagulation therapy.~   "
21881|NCT03280628|"~     There are several methods of closing a skin cut: stitches, skin glue, and medical tape.~     Stitches have been used for a long time to close skin cuts. Skin glue (invented in the 1970s)~     and medical tape (invented in the 1960s) are two newer methods to close skin cuts. The~     purpose of this study is to find out which method (stitches, skin glue, or medical tape) of~     closing skin cuts results in the least amount of scarring. Other things the investigators~     will be looking at are which method is the cheapest, which causes the least pain, which~     requires the least amount of sedation, and which method patients and parents like the best.~   "
21882|NCT03280615|"~     To study the tolerance and efficacy of an omega 3 fatty acids supplement on renal and~     vascular function and inflammatory parameters in patients with chronic renal disease~   "
21883|NCT03280602|"~     The incidence of olecranon fractures is 12 per 100.000. Traditionally, isolated olecranon~     fractures have been treated with tension band wiring (TBW). There is a trend towards~     increased use of plate fixation, though TBW has yielded good and comparable patient reported~     outcomes. The latter method is substantially cost-effective, but higher complication reports~     have been reported. There are only two randomized controlled trials comparing TBW and plate~     fixation, and the literature is inconclusive in which fixation method is preferable in the~     treatment of olecranon fractures. In this multi-center trial, adult patients (18-75 years)~     with isolated olecranon fractures will be randomized to either TBW or plate fixation.~   "
21884|NCT03280589|"~     The proposed study design will be a randomized, cross-over trial testing different pranayama~     breathing interventions. Participants (N=40) will perform each of the following five~     interventions in a randomly assigned order: (1) internal-paced pranayama intervention~     (Sheetali/Sheetkari for 10 minutes each) (2) internal-paced deep breathing control (3)~     external-paced pranayama intervention at a rate of 6 bpm (4) external-paced deep breathing at~     a rate of 6 bpm (5) sitting quietly with no external instruction.~   "
21885|NCT03280576|"~     Progranulin blood concentrations in patients with sepsis will be analysed in relation to~     disease status in order to validate progranulin as a biomarker for sepsis. Patients~     undergoing cardiac surgery will serve as controls.~   "
21886|NCT03280563|"~     This study is designed to evaluate the efficacy, safety, and pharmacokinetics of several~     immunotherapy-based combination treatments in participants with metastatic HR-positive,~     HER2-negative breast cancer who have progressed during or following first-line metastatic~     treatment with a cyclin-dependent kinase (CDK) 4/6 inhibitor such as palbociclib, ribociclib,~     or abemaciclib. The study will be performed in two stages. During Stage 1, participants will~     be randomized to fulvestrant (control) or an atezolizumab-containing doublet or triplet~     combination. Those who experience disease progression, loss of clinical benefit, or~     unacceptable toxicity may be eligible to receive a new triplet combination treatment in Stage~     2 until loss of clinical benefit or unacceptable toxicity. New treatment arms may be added~     and/or existing treatment arms may be closed during the course of the study on the basis of~     ongoing clinical efficacy and safety as well as the current treatments available.~   "
21887|NCT03280550|"~     The purpose of this study is to determine the efficacy and safety of omalizumab compared with~     placebo in adult participants with chronic rhinosinusitis with nasal polyps (CRSwNP) who have~     had an inadequate response to standard-of-care treatments.~   "
21888|NCT03280537|"~     The purpose of this study is to determine the efficacy and safety of omalizumab compared with~     placebo in adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) who have had~     an inadequate response to standard-of-care treatments.~   "
21889|NCT03280524|"~     This is a randomized, controlled and blind clinical trial with 60 type 2 diabetes patients~     divided into 2 groups of 30 patients each, Control Group (CG) and Treatment Group (TG). The~     TG will receive self-care guidelines with feet and 12 sessions of foot reflexology, while the~     CG will only receive the guideline.~   "
21892|NCT03280485|"~     Traumatic brain injuries (TBI) are one of the most common reasons for patients to attend the~     emergency department (ED). 90% of patients with TBI are defined as mild TBI (mTBI).~      A small minority of patients with mTBI would show pathological computed tomography (CT)~     results and even fewer need neurosurgical intervention. Nevertheless, complications would be~     so severe, if neurosurgical intervention is delayed, that it has become common practice to~     subject all patients with mTBI to CT. The high number of CT scans has an impact on health~     care resources but may also involve risk by subjecting patients through potentially harmful~     ionizing radiation.~      Several independent research groups have attempted to optimize CT use in mTBI patients by~     forming guidelines that aim to identify patients at high risk for intracranial complications.~     Most guidelines have been published in the past 15 years and have been validated both~     prospectively internally and externally; all guidelines have been shown to be safe when~     implemented in clinical use with few missed complications. However the number of CT scans has~     not been reduced dramatically, in some cases it has even increased.~      In 2013, the new Scandinavian guidelines (SNC13) were published. They are the first~     guidelines that use a biomarker, S100B, as a tool for managing patients with mTBI. Although~     S100B has a low specificity for intracranial complications, a high sensitivity makes it~     suitable to be implemented into clinical practice as a tool for CT reduction. Previous SNC~     guidelines have been compared to other prominent guidelines with impressive results. The~     SNC13 have been externally validated in a retrospective study from the USA that was~     underpowered for important outcomes. Nevertheless, SNC13 have already been partially~     implemented in clinical practice in Scandinavia. However, a strict multicenter validation has~     not been performed yet nor a systematic comparison to other available guidelines.~      Our primary aim is to validate the performance of the SNC13 in predicting intracranial~     complications in adult patients presenting with traumatic head injury in Swedish hospitals. A~     secondary aim is to compare the performance of SNC 13 with 6 other clinical guidelines, with~     respect to important outcomes. Moreover, to explore the performances of different biomarkers~     in predicting intracranial complications in predefined subgroups of TBI. Finally, to evaluate~     the possibility of further improvement of the SNC13.~   "
21893|NCT03280472|"~     The current project will test whether a computerized training program, Cognitive Bias~     Modification (CBM), can be used as a prevention inoculation tool to reduce vulnerability to~     anxiety among incoming college students. Those not in the CBM condition will complete a~     symptom tracking condition (ST). We will also test whether ST influences vulnerability to~     anxiety among incoming college students.~   "
21894|NCT03280459|"~     Continous evaluation of clinical and oncologic outcome of robot-assisted cystectomy with~     intracorporeal reconstruction of urinary diversion. Patient Data is entered in an anonymized~     registry for analyzation.~   "
21895|NCT03280446|"~     This study will evaluate the clinical efficacy of a Transcutaneous Fractional Radiofrequency~     Device (TFRF) for the treatment of vaginal laxity (VL) and urogynecological symptoms.~   "
21896|NCT03280433|"~     This translational study was designed to explore the association of the quantity and quality~     of epicardial adipose tissue (EAT) with coronary artery disease (CAD), left atrial remodeling~     and postoperative atrial fibrillation in a high cardiovascular disease-risk population. The~     investigators expect to identify new biochemical factors and biomarkers in the crosstalk~     between the epicardial adipocytes, coronary plaques and atrial cardiomyocytes that are~     involved in the pathogenesis of atherosclerosis and atrial fibrillation, respectively.~   "
21897|NCT03280420|"~     The aim of this work is to compare between early (3days) and late(7days) removal of urinary~     catheter after acute urine retention in patients with Benign Prostatic Hyperplasia under~     Tamsulosin treatment.~   "
21898|NCT03280407|"~     The main clinical hypothesis is that compared to radio-chemotherapy for low and mid rectal~     tumors or surgery for high rectal tumors neoadjuvant chemotherapy reduces the rate of distant~     relapse without increasing the rate of local relapse.~      The aim of the present study is to compare long term and short term outcomes in rectal cancer~     patients undergoing standard treatment (radio-chemotherapy/surgery) or experimental~     neoadjuvant chemotherapy/surgery Furthermore, early surgical and medical complications, the~     functional outcome, toxicity and quality of life (QoL) may be improved if radiotherapy can be~     avoided.~      Exploratory analyses are planned in order to find potential predictive markers for selecting~     patients to either radio-chemotherapy/surgery or neoadjuvant combination~     chemotherapy/surgery.~   "
21899|NCT03280394|"~     The study aims at assessing whether cell free DNA genotyping can improve the accuracy of~     early prediction of cure in mature B-cell tumor patients and whether it represents an~     accessible source of tumor DNA for the sensitive identification of genetic biomarkers that~     refine the diagnostic workup, stratify prognosis and identify the emergence of~     drug-resistance mutations during treatment.~   "
21900|NCT03280381|"~     The investigators will establish an evidence base for the Nifty Feeding Cup by evaluating its~     effectiveness and caregiver satisfaction. The investigators will conduct a randomized~     crossover trial that compares the Nifty Feeding Cup to a standardized, generic medicine cup~     used to feed preterm infants with breastfeeding difficulties at Komfo Anokye Teaching~     Hospital (KATH) in Kumasi, Ghana.~   "
21901|NCT03280368|"~     In patients with non-valvular atrial fibrillation treated with dabigatran etexilate, the~     level of adherence will be measured using a questionnaire, the Danish National Prescription~     Registry and pillcount and will be related to plasma levels of dabigatran measured by liquid~     chromatography tandem mass spectrometry (LC-MS/MS) and coagulation assays. The aim of the~     study is to measure the level of adherence and evaluate the usefulness of different~     coagulation assays to measure adherence in these patients. Furthermore, the aim is to~     determine the correlation between the anticoagulant effect of dabigatran using different~     coagulation assays and plasma levels of dabigatran.~      Most studies so far have been performed in vitro with plasma samples spiked with dabigatran.~     In this study the present knowledge from results of coagulation assays in dabigatran spiked~     plasma samples will be compared to the results of coagulation assays using blood samples from~     real-life patients.~   "
21902|NCT03280355|"~     Patients with Chronic Obstructive Pulmonary Disease (COPD) experience physiological and~     psychological complications, such as shortness of breath, anxiety and depression. This has~     negative influence on their social life, daily activity level and overall quality of life.~     Patients can participate in a pulmonary rehabilitation program (PR) for the purpose of better~     managing of the disease and its symptoms and for avoiding future relapses and~     hospitalisations. However there is a large number of dropouts from PR, and therefore a need~     for investigation of new activities. Singing training may be one such potential relevant and~     motivating rehabilitation activity. This study aims to investigate the effects of singing~     training on both physiological and psychological aspects, and will compare the effects with~     that of physical training (golden standard in PR). Effects will be investigated in a~     randomised controlled trial (RCT) with 10 week intervention period. In all the study includes~     11 municipalities from around all regions of Denmark, and in all 220 participants.~   "
21903|NCT03280342|"~     Crossover, randomized, double blind: Q12h dosing in both periods; matching placebo for~     evening dosing during XR treatment; target dose: 100mg~   "
21904|NCT03280329|"~     Admission to an Intensive Care Unit (ICU) is one of the major causes of stress and both~     physical and emotional difficulties for critically ill patients, both because of the illness~     that caused the admission and of the ICU nevironment itself. Despite the use of protocols and~     tools to evaluate sedation, many patients continue to have high levels of anxiety. An~     inadequate treatment of this condition is associated with increased sympathetic activity~     which causes dyspnea and an increase in myocardial oxygen consumption. Sedative drugs, on the~     other side, may have significant side effects.~      In view of this, there is clear need to find new strategies and instruments allowing for the~     maximization of critical patients' comfort, by promoting pain, anxiety, stress and agitation~     relief and minimising the need of sedative therapy.~      The main hypothesis of this study is that the use of music therapy for critically ill~     patients can lead to a significant increase of the days free from neuroactive therapy~     (analgesics, sedatives, antianxiety meds, antipsychotics) in the first 28 days following~     Intensive Care Unit admission. To this purpose, data obtained from 3 groups of patients will~     be compared - a group with individual treatment administered by a music therapist and~     delivered by headphones, a group with a generalised treatment, through the creation of a~     weekly musical program continuously broadcasted in the hospital room, and a control group.~   "
21905|NCT03280316|"~     The investigators' goal is to compare the efficacy of three different management strategies~     (sacral neuromodulation, botulinum toxin, M receptor antagonist) in treating consistent OAB~     in patients with SVMs after surgery.~   "
21906|NCT03280303|"~     This Non-Interventional Study will describe and analyze the clinical use of palbociclib in~     routine clinical practice in the treatment of advanced breast cancer.~   "
21907|NCT03280290|"~     This is a preclinical study prior to the establishment of a cell therapy protocol applicable~     to humans.~      The main objective is to evaluate the decrease in alloreactivity of TCD4 + population by~     partial selective depletion of CD4 + CCR7 + graft to less than 50 % of CD4 + totals. To test~     the alloreactivity of donor T lymphocytes.~   "
21908|NCT03280277|"~     This pilot clinical trial studies how well ferumoxytol-enhanced magnetic resonance imaging~     (MRI) works in imaging lymph nodes in patients with rectal cancer that has spread from where~     it started to nearby tissue or lymph nodes. Ferumoxytol is a form of very small iron~     particles that are taken up by cells in normal lymph nodes and may work better in imaging~     patients with rectal cancer when given with MRI.~   "
21909|NCT03280264|"~     To evaluate the efficacy of KHK7580 orally administered up to 24 weeks for hypercalcemia in~     patient with parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo~     parathyroidectomy or relapse after parathyroidectomy.~   "
21910|NCT03280251|"~     Currently, there is no available drug to treat the symptoms of neurodegenerative and vascular~     cognitive disorders that affect millions of people worldwide.~      Methylphenidate is indicated at high dose (1 mg/kg/day) in children having attention deficit~     and hyperactivity disorder (ADHD) and remains the best cognitive enhancer drug at lower dose.~     However, there is no proof of efficacy with chronic administration, outside ADHD, and concern~     remains about long-term cardiac and vascular risks in elderly and particularly in population~     with vascular risk factors and drug abuse in young people. Moreover, the effect appears to be~     very limited at the very advanced stage of dementia, for which the neuronal plasticity is too~     reduced to expect a benefit of training.~      Taken all together, we sought to develop a new paradigm of association of both~     pharmacological and non-pharmacological procedure to enhance the neuronal plasticity in order~     to expect a persistent effect on slight to mild cognitive disorders with benefit on~     ecological test (i.e. driving). Finally, short-term treatment would reduce the safety~     concerns.~      The concept will be to prove that low dose of methylphenidate associated with active~     cognitive training during 6 weeks can improve the cognitive function in healthy aged~     volunteers with a persistent effect at 3 months.~   "
21911|NCT03280238|"~     Pain assessment is crucial in clinical practice. Currently, subjective self-report is~     considered the most appropriate method to evaluate pain. Although several methods to assess~     pain objectively exist, the lack of a golden standard still remains. This pilot study~     assesses the changes in pupil dilation (PD) and the analgesia nociception index (ANI) as a~     measure of pain in healthy, conscious, male volunteers in a highly standardized and~     individualized environment. Nineteen subjects received three blocks of 4 individualized~     electrical stimulus intensities, ranging from no to severe pain. Subjects reported their~     perceived severity of each individual stimulus, enabling the comparison of changes in PD and~     ANI in relation to both administered stimulus intensities and perceived pain severities. PD~     and ANI were measured before and after each administration of a stimulus.~   "
21912|NCT03280225|"~     The VA's Office of Mental Health and Suicide Prevention is implementing an new program to~     increase suicide prevention outreach for Veterans at highest risk for suicide. Using a~     statistical model, REACH VET, short for Recovery Engagement and Coordination for Health -~     Veterans Enhanced Treatment, uses information from Veterans' health records to identify those~     who are at a higher risk for suicide, hospitalization, illness, or other negative outcomes.~     Once a Veteran is identified, his or her VA mental health or primary care provider reaches~     out to check on the Veteran's well-being and review their treatment plan to determine if~     enhanced care is needed. The goal of the proposed study is to evaluate the implementation of~     this program in collaboration with the Partnered Evidence-based Policy Resource Center~     (PEPReC). The objectives of this evaluation are to evaluate how well this program is put into~     place using a strategy called virtual external facilitation, and to collect data about the~     cost of the program and the strategy.~   "
21927|NCT03280017|"~     Postoperative pain after thoracic surgery is associated with adverse outcomes. The current~     strategy to prevent postoperative pain is the use of regional anesthesia and analgesic~     agents. In video-assisted thoracic surgery (VATS), thoracic paravertebral block has become~     the standard analgesic regimen which results in decreased postoperative pain and opioid~     consumption.~      The investigator would like to study the analgesic efficacy of low dose intravenous ketamine~     infusion during surgery in combination with thoracic paravertebral block on postoperative~     pain after VATS in a randomized study.~   "
22624|NCT03270852|"~     The researchers found that enhanced reality developed for the first time in the word by us~     had a synergistic or additive effect on brain plasticity in patients without central nervous~     system injury. The aim of this study is to determine the validity and feasibility of enhanced~     reality in hemiparetic arm in the stroke patients with central nervous system injury.~   "
21913|NCT03280212|"~     Chronic subdural hematoma (CSDH) is a common disease after minor head trauma, especially in~     elderly patients. This medical condition is characterized by blood collection in the subdural~     space, which can result in severe neurological impairment. Current standard of care is the~     evacuation of the CSDH by means of different surgical approaches. Although clinical and~     surgical outcomes are satisfying in most cases, considerable morbidity and mortality as well~     as recurrence rates of 3-31% are frequently reported. Therefore a non-surgical approach for~     the treatment of CSDH would be desirable. Tranexamic acid (TXA), an antifibrinolytic drug has~     been shown to decrease hematoma volume in a small cohort of patients suffering from CSDH. The~     present study is designed to test the hypothesis that TXA can reduce the volume of CSDH.~     Volume measurements of residual CSDH after burr-hole surgery will be performed during study~     course to quantify treatment success. The trial is designed as a randomized controlled pilot~     study, where half of the patients will be assigned to daily intake of TXA, whereas the other~     half will receive medical treatment according to current practice without TXA prescription.~     The primary endpoint of the study is defined as volume change in milliliters (mL) after 4-8~     weeks of treatment. Secondary endpoints are hematoma volume change at 8-12 weeks, the rate of~     patients with resolution of the CSDH after 4-8 weeks and 8-12 weeks days, as well as the rate~     of reoperation during study course due to hematoma extension and neurological deterioration.~     Additionally the neurological outcome and the drug compatibility will be estimated as~     secondary objectives.~   "
21914|NCT03280199|"~     This study aims to explore the impact of different simulator characteristics on transfer of~     learning.~   "
21915|NCT03280186|"~     The investigators goal is to create a better understanding of patient with SVMs reported~     outcomes for bladder management strategies before and after surgery.~   "
21916|NCT03280173|"~     2 different formulations of tafamidis will be compared under both fed and fasted conditions.~     Subjects will be fasted overnight or fed. After swallowing one of the tafamidis formulations,~     tafamidis blood concentrations will be measured periodically for 8 days. After 16 days,~     subjects will take a different formulation in the fed or fasted state or take the same~     formulation in the opposite feeding condition. This will be repeated, 16 days apart, until~     all subjects have taken each formulation both fed and fasted.~   "
21917|NCT03280160|"~     Based on the promising results obtained with ibrutinib as single agent, the results obtained~     with ibrutinib in combination with ofatumumab in a previous phase I/IIb study (Jaglowski~     2015), and since data from in vitro studies do not support a synergistic effect of the~     combination of ibrutinib and anti-CD20 mAbs, we propose a chemotherapy-free combined strategy~     based on ibrutinib monotherapy as front line treatment for patients with CLL, with the~     addition of a consolidation phase with ofatumumab in patients not attaining CR under~     ibrutinib in order to improve the quality of their response. Since median time to CR with~     ibrutinib was nearly 12 months, patients will be evaluated at this time point, and those~     patients not in CR will add consolidated treatment with Ofatumumab. Thus, this multi-center,~     non-randomized phase 2 study is designed to evaluate the efficacy and safety of ibrutinib~     alone or in combination with Ofatumumab in patients no attaining CR under ibrutinib as~     front-line therapy for patients with chronic lymphocytic leukemia.~   "
21918|NCT03280147|"~     The optimum duration of intravenous antibiotic therapy for culture-proven neonatal bacterial~     sepsis is not known. Current practices, ranging from 7 days to 14 days of antibiotics, are~     not evidence-based. This is a randomized, active -controlled, multi-centric, non-inferiority~     trial to compare the efficacy of a 7-day course of intravenous antibiotics versus a 14-day~     course among neonates weighing > 1500 g at birth with culture-proven bacterial sepsis that is~     uncomplicated by meningitis, bone or joint infections deep-seated abscesses. The primary~     outcome measure is a definite relapse by the same etiologic organism within 21 days after~     stoppage of antibiotics.~   "
21919|NCT03280134|"~     In the previous study, the investigator established a predictive model for non-sentinel lymph~     node involvement in early breast cancer (cT1-2cN0, 1-2 SLNs involvement). To validation the~     clinical value of the model, the investigator design a prospectively research using the model~     guiding for further axillary lymph node dissection in SLN-positve early breast cancer.~   "
21920|NCT03280121|"~     Hernia Reduction Prior to Scheduled TIF Completion using EsophyX ZR transoral device~   "
21921|NCT03280095|"~     The purpose of this study is to compare the bioavailability of co-codamol 15mg/500mg capsules~     (test product) and co-codamol 30mg/500mg tablets (reference product).~   "
21922|NCT03280082|"~     The aim of this study is to provide comprehensive documentation of the relevant results and~     operational implications of this new model using Mid-Upper Arm Circumference (MUAC) as the~     single anthropometric criterion for admission, monitoring and exit of non- complicated in~     Niger.~   "
21923|NCT03280069|"~     This protocol will evaluate THERMIeyes® for its ability to treat periorbital skin laxity and~     wrinkles and monitor ocular surface changes and their effect on evaporative dry eye~     associated with MGD.~   "
21924|NCT03280056|"~     This study will evaluate the safety and efficacy of repeated administration of NurOwn®~     (MSC-NTF cells) therapy, which is based on transplantation of autologous bone marrow derived~     mesenchymal stromal cells (MSC), which are enriched from the patient's own bone marrow,~     propagated ex vivo and induced to secrete Neurotrophic factors (NTFs).~      The autologous NurOwn® (MSC-NTF cells) are back-transplanted into the patient intrathecally~     by standard lumbar puncture where neurons and glial cells are expected to take up the~     neurotrophic factors secreted by the transplanted cells~   "
21925|NCT03280043|"~     The investigators hope to answer the question, does ketorolac increase the risk of hematoma~     after reduction mammoplasty? using a case-control study. All patients who developed a~     hematoma post reduction mammoplasty (cases) at our institution, and match these with women~     who had an uncomplicated reduction mammoplasty (controls), and then compare frequency of~     ketorolac exposure between these two groups as the primary outcome. If ketorolac increases~     the risk of hematoma, one should expect cases to have been exposed to ketorolac more~     frequently than controls. Based on previously existing literature, the investigators~     hypothesize that cases and controls will not differ in their ketorolac exposure, that is,~     ketorolac does not increase the risk of hematoma.~   "
26103|NCT03225287|"~     The purpose of this study is to enable continued access to RA101495 for patients with~     paroxysmal nocturnal hemoglobinuria (PNH) after they complete a RA101495 clinical study.~   "
21931|NCT03279965|"~     This is a small pilot / feasibility study (Approximately 50 patients) to assess the~     possibility of clinical implementation of MRI assessment of patients with cystic fibrosis and~     primary ciliary dyskinesia.~      Patients will undergo their standard CT imaging and lung function investigations and~     additionally will undergo MRI examination. Reports from CT (the current gold standard) and~     MRI will be assessed for concordance and patient acceptability and examination implementation~     costs will also be assessed. Novel MRI-based potential markers of CF and PCD disease state~     will also be assessed.~   "
21932|NCT03279952|"~     There has been an increasing focus on the adverse impacts of irritability, defined as~     increased tendency towards anger. Irritability worsens peer relationships, family~     functioning, academic performance and is a risk factor for depression, suicide and substance~     use and is one of the main reasons why children get referred for treatment. It has been~     identified as transdiagnostic entity meriting investigation as a treatment target for~     personalized intervention given its prevalence and morbidity. Most children with prominent~     irritability also meet criteria for Attention Deficit Hyperactivity Disorder (ADHD) but only~     a subset of children with ADHD manifest impairing levels of irritability. Irritability levels~     are only minimally correlated with severity of ADHD symptoms suggesting that irritability is~     not simply a manifestation of severe ADHD. The first line treatment for irritability in~     children with ADHD is to optimize the dose of the CNS stimulant. However, there is great~     heterogeneity in response, with baseline mood lability being the best marker for both~     improving and worsening irritability. In addition, increased irritability is one of the most~     common reasons why parents stop these medications. The unpredictability in response to CNS~     stimulants has led to the increasing use of antipsychotics and other non-evidence based~     treatments for ADHD. It is unknown what drives this heterogeneity in response in part because~     little is known about the underlying causal mechanisms for irritability in youth with ADHD.~     Two areas theorized to contribute to irritability include impairments in learning from~     experience (instrumental learning) and sensitivity to reward and loss.1 There are objective~     methods for measuring these domains in children through the use of even-related potentials~     (ERPs)- synchronous neural activity in response to a stimulus. Reward positivity (RewP) is an~     ERP component occurring in response to feedback on task performance that can be broken down~     to separate reward and loss components. Irritability is thought to arise due to the~     combination of an enhanced drive for reward coupled with an excessive response to loss. No~     prior work has examined associations of RewP with irritability in ADHD. However,~     abnormalities in RewP and elevated irritability have both been established as risk factors~     for depression, suggesting that RewP may also predict irritability. Error related negativity~     (ERN) reflects the preconscious detection of potential conflict serving as an early warning~     signal for errors. Error detection is one of the first steps for instrumental learning. It is~     impaired in some youth with ADHD, with a suppressed ERN correlated with reduced error~     processing. CNS stimulants improve ERN amplitude and impaired error processing. We theorize~     that abnormalities in RewP and ERN in children with ADHD will serve as respective markers for~     severity of irritability and subsequent treatment response to CNS stimulants. If successful,~     we will have identified a causal pathway for irritability that will aide treatment~     development and identified a reliable biomarker for the current first line treatment for~     irritability in ADHD (CNS Stimulants), while providing care to a significantly impaired group~     of local children for whom few evidence-based treatments exist.~   "
21933|NCT03279926|"~     The overall aim of this proposal is to develop and test early childhood education~     setting-based physical activity (PA) interventions that are innovative by using wearable~     technology to facilitate monitoring, feedback and motivation for physical activity across~     multiple levels (child, parent, educator). We posit that our intervention strategies will~     promote behavior changes in parents and educators, leading to greater awareness and~     communication about physical activity, more active play opportunities, and ultimately more~     physical activity for preschoolers. In the R21, we will test the acceptability, feasibility~     and initial efficacy of three 6 month early childhood education setting- based, multi-level~     interventions to promote preschoolers' PA using wearable technology and additional behavior~     change techniques to engage educators and parents. The results of this study will inform a~     larger intervention trial.~   "
21934|NCT03279913|"~     Neurofeedback is an increasingly researched technique for the treatment of many psychological~     disorders, such as attention deficit / hyperactivity disorder (AD / HD), depression, or~     substance abuse. This technique would allow patients to regulate their cortical~     electroencephalographic activity while receiving a visual or auditory feedback on the~     cortical electroencephalographic activity. Changes in the electroencephalogram (EEG) would~     thus be correlated with changes in cortical activity and thus with symptoms.~      On the electroencephalographic plane, the depression appears associated with relatively more~     alpha activity (in resting state, 8-13 Hz) in left than in right frontal cortex. This~     difference in alpha activity between frontal regions is known as alpha asymmetry in~     depression. As a reminder, increased alpha activity indicates a decrease in cortical~     activation. This alpha asymmetry appears to be associated with a decrease in sensitivity to~     reward.~      It is on these bases that the modification of the alpha asymmetry has become one of the most~     frequent objectives of the studies on the use of neurofeedback in depression.~      Transcranial magnetic stimulation (TMS) also offers a non-invasive and painless method of~     effective cerebral stimulation in psychiatric disorders and especially depression. It~     received a favorable opinion from the Food & Drug Administration (FDA) in the United States~     for the treatment of this pathology. This treatment is still under evaluation in France. The~     results are promising but improvements must be done to increase its effectiveness.~      TMS offers stimulation of brain tissue in a localized and non-invasive manner. The principle~     consists of a brief electric current passing through a coil which generates a transient~     magnetic field inducing an electric field through conductive fabrics. TMS modifies neuronal~     activity in target superficial brain structures, but also modulates neuronal circuit~     activity.~      In recent years, the concept of state dependency TMS has been developed. It suggests that~     the activation state of neuronal circuits before and after stimulation alters the effect of~     stimulation. Thus, the efficacy of TMS could be amplified in depression by taking into~     account the cerebral activity during the stimulation sessions, in particular on the~     electroencephalographic plane.~      However, TMS may also help patients increase their EEG response during Neurofeedback~     sessions.~      The combination of stimulation techniques and brain-machine interfaces such as neurofeedback~     is still little studied at present.~      A study on the combined use of TMS and Neurofeedback by EEG in depression would therefore be~     an innovative approach and in line with the latest data from the literature.~      Design : Prospective, monocentric, non-randomized, non-comparative, unblinded study.~   "
21935|NCT03279900|"~     This study use an observational study design from patient medical records to obtain data on~     patient demographics, nutritional status, 6MP dosing, and albumin levels of LLA child~     patients.~   "
21936|NCT03279887|"~     Diagnosis of pneumonia remains difficult in intensive care unit (ICU), notably after cardiac~     surgery. Lung ultrasonography (LUS) has been successfully used for diagnosis of pneumonia,~     but its usefulness and reliability was never evaluated after cardiac surgery. This study~     investigates the clinical relevance of LUS for pneumonia diagnoses in cardiac ICU.~   "
21937|NCT03279874|"~     The aim of the present study is to determine dentists' barriers and facilitators for~     performing repairs on partially defective dental restorations.~   "
21938|NCT03279861|"~     This pilot, feasibility study evaluates the efficacy of sacubitril-valsartan (Entresto)~     versus usual anti-hypertensive medications in patients with left ventricular assist devices~     (LVAD). It also measures diurnal blood pressure variations in the context of continuous flow~     physiology.~   "
21939|NCT03279848|"~     Objective: To make use of admission Modified Functional Ambulation Category (MFAC) as a~     stratification tool to reveal profiles of functional outcomes of patients with stroke in~     inpatient rehabilitation.~      Design: This was a retrospective, descriptive study of the demographic, functional outcomes~     of patients with stroke in an inpatient rehabilitation centre. A total of 2,722 patients~     completed a stroke rehabilitation program from 2011 to 2015 were recruited.~   "
21940|NCT03279835|"~     The objective of this prospective study is to evaluate the prevalence of neurocognitive~     impairments in HIV infected patients comparing patients with and without HAART. Recent~     studies have demonstrated a specific HIV infected patients neurocognitive disorders profile.~     These cognitive disorders concern primarily information processing speed, memory recall,~     attentional abilities, work related memory, executive functions, and psychometrical speed.~     This cognitive profile is similar to another highly documented one, described for another~     central nervous system disease (CNS): multiple sclerosis. In both CNS diseases, the earliest~     and most severe disorder is the one related to the information processing speed. For the~     multiple sclerosis patients, a short cognitive test (SDMT) is actually used not only to~     identify cognitive disorders presence, but also in order to predict a long term disability~     worsening. A digital version of this test (CSCT), has recently been developed in order to~     make this early evaluation easier. We hypothesize that CSCT alteration would also predict~     HAND, in HIV infected patients. A complete neuropsychological assessment is highly time and~     personal consuming. This short (approximatively 2 minutes) digital test would be highly~     helpful to identify patients, who will need a more extensive neuropsychological assessment.~   "
21941|NCT03279822|"~     This is an observational study to analysis the association factors for common diseases,~     including chronic obstructive pulmonary disease, coronary artery disease, hypertension,~     diabetes etc, based on resident healthcare records. More than 10 million resident healthcare~     records should be collected for the associations study by using big data methods.~   "
21952|NCT03279679|"~     The costoclavicular space block technique is a new developed approach of ultrasound-guided~     infraclavicular brachial plexus block(USG-ICB) in last two years and has not been studied~     much yet. The paracoracoid approach serves as a standard and traditional method for USG-ICB~     in clinical practice, easy to learn and perform. The investigators set this parallel~     controlled dose-finding trial to work out the MEV with 0.5% ropivacaine of both two~     approaches above for forearm surgery and compare the performance time between them, providing~     reasonable evidence for clinical choice.~   "
21942|NCT03279809|"~     The aim of this study is to determine whether administration of aspirin can help maintain the~     patency of metallic stents for distal malignant common bile duct obstruction. Metal stents~     are mainly used for malignant biliary obstruction if the surgical treatment is not considered~     and its maintenance period has been reported to be about 8 months. We prospectively conducted~     randomized controlled study with aspirin treated patients who received metal stents in~     patients over 20 years who were confirmed malignant distal biliary obstruction. The primary~     endpoint is the incidence of stent dysfunction in both groups for 6 months after the~     procedure. The secondary endpoints included duration of metalic stent patency, incidence of~     further procedures, and adverse events related with aspirin.~   "
21943|NCT03279796|"~     This study was a single-center, randomized, single-blind clinical trial. We plan to include~     100 patients who met exclusion criteria of rotator cuff and lateral epicondylosis (tennis~     elbow) respectively by MRT or ultrasonography. The patients will be randomly divided into two~     groups. Adipose mesenchymal stem cells will be isolated from adipose tissue, cultured and~     then transplanted back to the tendon injury site by multiple point injection. 1*10^6 cells as~     an unit. Patients in the experiment group will be injected into an unit of adipose~     mesenchymal stem cells (1*10^6/10kg) while the control group received the same dose compound~     betamethasone injection. Follow up visit for all patients will occur at 1，3，6 and 12 months~     after the first injection. Clinical quantitative assessment will measure by the visual~     analogue scale(VAS). The secondary outcomes are the constant-murley score(CMS) and the rating~     scale of the American shoulder and elbow surgeons(ASES) and the disability of arm shoulder~     and hand(DASH). The objective evaluation methods is that the examination of MRI or ultrasound~     were accomplished before the first injection and at 6 and 12 months afterwards.~   "
21944|NCT03279783|"~     Although colonoscopy with polypectomy can prevent up to 80% of colorectal cancers, a~     significant adenoma miss rate still exists, particularly in the right colon. Optimizing the~     detection of adenomas and sessile serrated lesions in the right colon is crucial to increase~     the effectiveness of colonoscopy in colorectal cancer prevention.~      Last generation Fuji videocolonscopes incorporates the Linked Color Imaging (LCI), a recently~     developed technology that differentiates the red colour spectrum more effectively than White~     Light imaging thanks to its optimal pre-process composition of light spectrum and advanced~     signal processing. The increased colour contrast results in more accurate delineation of~     abnormal inflammatory or neoplastic findings of colonic mucosa. Preliminary data suggest that~     LCI may be improve the detection of neoplastic lesion of colon.~      The investigators performe a tandem prospective study to compare the right colon adenoma miss~     rates of LCI colonoscopy with those of conventional white light colonoscopy.~      Therefore participants scheduled for colonoscopy for the assessment of symptoms or for~     colorectal cancer screening/surveillance receive the examination of the right colon twice, in~     a back to back fashion, with standard white light (WL) and with LCI. Patients are randomly~     assigned (1:1), via computer-generated randomisation with block size of 20, to which~     procedure is done first. The endoscopist are masked to group allocation until immediately~     before the cecum is reached. Examinations are performed with Fuji videocolonscopes series 700~     (EC-760R, EC-760ZP).~   "
21945|NCT03279770|"~     Cardiovascular diseases and stroke are the major causes of morbidity and death in Taiwan.~     There is a clear need to identify novel mediators of atherosclerosis in dyslipidemic patients~     to provide insights into the pathogenesis, to tailor clinical care based on cardiovascular~     risks, and to develop new therapeutic strategies.~      While the roles of lncRNAs in human diseases including cancer and neurodegenerative disorders~     are beginning to emerge, it remains unclear how lncRNA regulation contributes to~     atherosclerotic vascular diseases in patients with dyslipidemia. In this proposal, we seek to~     apply next-generation sequencing technology to investigate circulating (plasma and peripheral~     blood mononuclear cells [PBMC]) lncRNA expression in control subjects and in dyslipidemic~     patients with and without atherosclerotic vascular diseases (CAD, ischemic stroke and PAOD).~     The results from these experiments will lead to better understanding of how circulating~     lncRNAs contribute to atherosclerotic cardiovascular complications.~   "
21946|NCT03279757|"~     The purpose of this study are to compare the efficacy of two different commercially available~     local anesthetics on AFXL pretreated skin and to assess the role of the application time in~     this technique.~   "
21947|NCT03279744|"~     A Prospective, Single-Arm, Open-Label, Phase II Study to Evaluate the Efficacy and Safety of~     Photodynamic Therapy Using Radion™-pdt in Patients with Oral Precancerous Lesion (Oral~     Verrucous Hyperplasia or Oral Erythroleukoplakia).~   "
21948|NCT03279731|"~     The study is a 17-week, single-center, double-blind, parallel-group, randomized placebo~     controlled trial that will test the efficacy of liraglutide 3.0 mg/d as compared to placebo~     in reducing the number of binge episodes per week, achieving remission from binge episodes,~     and in changes in body weight, global BED symptom improvement, cognitive restraint of food~     intake, dietary disinhibition, perceived hunger, quality of life, and depressed mood at~     treatment end.~   "
21949|NCT03279718|"~     Current data are showing a potential link between inflammatory biomarkers in chronic~     periodontitis and COPD. However the impact of periodontal treatment on systemic inflammation~     as measured by biomarkers and time to occurrence of acute exacerbations (AECOPD) remains an~     important but unresolved issue. This pilot study will provide information on effects of~     periodontal treatment on systemic inflammation and the course of COPD including acute~     exacerbation.~      40 patients with chronic periodontitis and COPD will be included in this study. First~     baseline information (age, gender, lifestyle, smoking history, medical history, medication,~     frequency of exacerbation, dental treatments) are recorded. Then patient's health status is~     assessed using the COPD Assessment Test (CAT) and a comprehensive lung function testing~     (bodyplethysmograph) is conducted to assess lung functional severity of COPD. Blood samples~     are taken for analysis of various inflammatory biomarkers and saliva and sputum samples are~     collected for analysis of microbiome.~      Afterwards experienced dentists will conduct oral health examination and record the~     periodontal conditions of every patient. Samples of gingival crevicular fluid for determining~     Matrix metallopeptidase 8 (MMP8), Interleukin 1 beta (IL-1beta) and Interleukin 6 (IL-69~     levels and for microbiome analysis will be taken. After randomization to one of the two study~     groups (intervention group: periodontal treatment / control group: no periodontal treatment)~     all patients get comprehensive oral hygiene instructions, irrespective of their periodontal~     status . Patients of the control group receive no further planned dental intervention. For~     patients of the experimental group, who need periodontal treatment due to the presence of~     periodontal pocket depth of ≥ 4 mm an appropriate care plan will be determined and supra- and~     subgingival scaling and root planing will be performed.~      During a 3, 6 and 12 months follow-up patient's current health condition will be assessed~     using the CAT. Additionally lung function tests (bodyplethysmograph) will be performed and~     clinical periodontal parameters are re-evaluated. To detect and assess COPD exacerbations in~     this trial, patients will complete a daily diary during the whole follow-up period which will~     be provided to the clinical researcher at each study visit. Furthermore the cough and sputum~     assessment questionnaire (CASA-Q)) will be used at each telephone call and at each visit in~     the pulmonary center. After 6 and 12 months blood, sputum, saliva and gingival crevicular~     fluid will be taken additionally. To understand the microbial ecology mechanisms linking~     periodontitis to COPD combined analysis of oral cavity microbiome (GCF) and lung microbiome~     (sputum) will be conducted. The biomarkers high sensitive C-reactive Protein (hsCRP), MMP8,~     IL-1beta und IL-6 will be determined in blood and in gingival crevicular fluid, respectively.~   "
21955|NCT03279640|"~     Repetitive transcranial magnetic stimulation (rTMS) or transcranial direct current~     stimulation (tDCS) has been used for the modulation of stroke patients' motor function by~     altering the cortical excitability. Recently, more challenging approaches, such as~     stimulation of two or more sites or use of dual modality have been studied in stroke~     patients. In this study, simultaneous stimulation using both rTMS and tDCS (dual-mode~     stimulation) over bilateral primary motor cortices (M1s) was investigated to compare its~     modulatory effects with single rTMS stimulation in subacute stroke patients.~   "
21956|NCT03279627|"~     The purpose of this study is to identify and explore the existing components of discharge~     planning provided to patients with insulin treated diabetes in the inpatient setting and to~     examine the contribution of glycemic excursions as well as comprehension of discharge~     instructions among patients with diabetes, in predicting hospital readmissions.~   "
21957|NCT03279614|"~     Currently, there is no standard second line treatment for patients with neuroendocrine~     carcinoma. SOX regimen has shown promising in previous study. The study was designed to~     confirm thet SOX regimen can be used as a second-line regimen for patients with advanced or~     metastatic neuroendocrine carcinoma who have progressed after first-line chemotherapy with~     platinum based regimen.~   "
21958|NCT03279601|"~     The study will be conducted to compare the safety and efficacy of Capecitabine Combined With~     Dacarbazine(CAPDTIC) and Capecitabine Combined Temozolomide(CAPTEM) in advanced or metastatic~     gastrointestinal pancreatic and esophageal neuroendocrine tumor.In this prospective~     randomized phase II study, the investigators aim to compare the survival benefit as well as~     the safety forCapecitabine Combined With Dacarbazine(CAPDTIC) versus Capecitabine Combined~     Temozolomide(CAPTEM) in advanced or metastatic gastrointestinal pancreatic and esophageal~     neuroendocrine tumor.~   "
21959|NCT03279588|"~     Colonic diverticulitis is a common clinical condition in patients presenting to the Emergency~     Department (ED) with abdominal pain. The diagnosis and staging of patients with suspected~     acute diverticulitis is often made by CT imaging with intravenous contrast, which involves~     radiation exposure, is expensive and has contraindications. The aim of this study is to~     evaluate the diagnostic accuracy and role of bedside abdominal US for the diagnosis of acute~     diverticulitis~   "
21960|NCT03279575|"~     The objective of this study is to compare the efficacy of two behavioral interventions at~     recalibrating physician heuristics.~   "
21961|NCT03279562|"~     In collaboration with the First Pavlov State Medical University in St. Petersburg, Russia, we~     are proposing a pilot, open label, non-randomized clinical trial to evaluate the safety,~     feasibility, acceptability, and preliminary efficacy of treatment for alcohol and opioid use~     disorders combining Nalmefene and recovery coaching (educational and behaviorally oriented~     drug counseling). The proposed pilot study will also be used to further develop and refine~     the recovery coaching/counseling intervention and to train additional cadre of clinicians and~     researchers in St. Petersburg, Russia.~   "
21962|NCT03279549|"~     Burns are common injuries in the daily life and wars. With the development of medical~     techniques, the mortality has been significantly reduced. However, the deformity and~     disability caused by hypertrophic scar have not been improved effectively since the wound~     repair technology is limited and controversial, especially on the early treatment of deep~     second degree burns. The prognosis of burns is of great difference. In recent years, the~     promotion of wound repairing technologies provides a new opportunity for improving the~     quality of wound healing and solving the problem of scar formation. Although some new methods~     and techniques have shown significant efficacy in clinic, clinical researches with large~     samples conducted in multiple centers are still deficient, impeding the evaluation of their~     superiority. Therefore, the current protocol focuses on the repair of deep second degree~     burns based on previous researches. There are four types of treatment protocols for wounds.~     Patients were divided into four groups randomly, including regular dressing change group,~     controlled debridement + biological dressing covering group (xenogeneic acellular dermal~     matrix), controlled debridement + epidermal cell cultivation group, controlled debridement +~     bFGF treatment group. The wound healing rate, healing time and scar formation were observed.~     The availability and security were evaluated. Further more, treatment guidelines and expert~     consensuses on deep second degree burn wounds were concluded. Above studies are important to~     promote the treatment of deep second degree burns to be scientific, standardized and~     professional in China.~   "
21963|NCT03279536|"~     This study consisted of 60 cases. All the cases of pregnant women are 4 months to 8 months of~     pregnancy. The cases divided into 30 pregnant women's were given iron supplementation without~     health education and another 30 were given iron supplementation and health education for~     comparison between them. Comparative between hemoglobin levels before and after medication.~     Treatment of iron deficiency anemia with iron supplementation received for one month.~   "
21964|NCT03279523|"~     This project will collect quantitative pilot data that will allow the characterization of~     uptake and binding of 18F-AV-1451 (also known as F 18 T807, also known as T807, also known as~     7-(6-fluoropyridin-3-yl)-5H-pyrido[4,3-b]indole), a novel tau imaging compound, in older HIV+~     individuals with and without HAND and matched HIV uninfected (HIV-) controls. The primary~     goal is to develop this highly promising tau imaging technique as an biomarker of cognitive~     decline in HIV+ individuals. The investigators will obtain preliminary data that will support~     the possibility of detecting early brain pathological changes due to HIV. Data generated from~     this study will be used for submission of National Institutes of Health (NIH) grants~     comparing tau deposition in HAND compared to other neurodegenerative disorders. It is~     hypothesized that specific topographies will help distinguish these neurodegenerative~     disorders in older individuals.~   "
21965|NCT03279510|"~     Hearing aids are used to improve audibility for patients with hearing loss and improve speech~     perception. In addition to these immediate benefits, amplification has the potential to have~     long-term effects on higher level auditory processing abilities, such as cognition or other~     abilities required for complex listening tasks. These long-term acclimatization effects are~     not well understood and merit further behavioral and physiological examination. Hearing aids~     will be fit on inexperienced hearing aid users and outcome measures will be used to determine~     immediate and long-term effects of hearing aids. This research may provide a more detailed~     view of individual differences that contribute to receiving benefit from a hearing aid and~     may lead to more individualized treatment of hearing loss.~   "
21968|NCT03279471|"~     Approximately 40%-80% of children and adolescents with autism spectrum disorder (ASD) exhibit~     clinically significant anxiety symptoms. These symptoms are associated with increased social~     deficits, depression, irritability, and stereotyped and self-injurious behaviors. Children~     and adolescents with anxiety also frequently avoid potentially stressful situations, thereby~     missing opportunities to learn important new skills. However, there is a lack of clarity~     about how to differentiate ASD and anxiety symptoms. There is also little known about how~     anxiety manifests in those with ASD and intellectual disability (ID). The goal of this study~     is to investigate these issues in order to make interventions more precise, more~     personalized, and more likely to promote positive outcomes~      While there is no doubt that anxiety is a very serious issue for those with ASD, what to do~     about this problem is less clear. Multiple small trials have provided promising evidence that~     selective serotonin reuptake inhibitors (SSRIs) and cognitive behavior therapy (CBT) might~     reduce anxiety in those with ASD. However, this work is in its early stages. In this study we~     will conduct a study in children with ASD and clinically significant anxiety ages 8-12 to~     compare efficacy of these different treatment types.~   "
21969|NCT03279458|"~     Many post-operative complications arise from patients who breathe inadequately. Inadequate~     respiration, whether the result of surgery or the anesthesia, causes a decrease in blood~     oxygen saturation and an increase in carbon dioxide partial pressure. Both of these surrogate~     measurements of respiration may pose a challenge to measure. Some administer exogenous oxygen~     to all patients as they leave the operating room in order to maintain the blood oxygen~     saturation. This renders the oximeter a less sensitive metric of depressed respiration. In~     the face of decreased respiration, the carbon dioxide levels continue to increase slowly and~     often go undetected unless blood gases are measured. Indeed carbon dioxide blood levels are~     the only metric to detect inadequate ventilation using this surrogate index.~      Monitoring ventilation is a serious challenge outside of critical care settings. In fact,~     there are no monitors available that can measure tidal volume or relative tidal volume~     outside of these settings.~      Linshom is a novel instrument that tracks relative respiration by measuring the excursions of~     the temperature swings between inspiration and expiration and normalizing them to the~     patient's breathing. This monitor may be the first non-invasive monitor to measure relative~     tidal volume in non-critical care settings.~      The purpose of this study is to determine whether a non-invasive, temperature-based~     respiratory instrument can track tidal volume (Vt) in patients.~      The investigators hypothesize that the Linshom device can accurately and consistently track~     tidal volume as measured by closed loop mechanical ventilator.~   "
21970|NCT03279445|"~     More than 10 million people worldwide are living with Parkinson's disease (PD). While the~     actual number of African Americans with PD is unknown, it is clear that there are racial~     disparities in the access to health care, and diagnosis and treatment of PD. The lack of~     clear knowledge on the lower PD prevalence among African Americans compared to Caucasians~     further calls for more research in this field. The University of Chicago Medicine is an ideal~     facility to study this topic, due to its location on the South Side of Chicago with large~     African American population. By analyzing the demographics, socioeconomics and clinical~     features of PD patients in our Center for Research Informatics in African Americans compared~     to the Caucasians of similar geographical area all accessible to the same health care~     facility, the Investigators aim to work toward a better understanding of the unique features~     of PD in American Americans, which might help improve the healthcare among the African~     Americans in Chicago and possibly nationwide. Blood will also be drawn during follow-up~     visits for future genetic studies, which might also help understand the genetic aspect of the~     disparity in PD.~   "
21971|NCT03279432|"~     The link between metabolic disturbances and vitamin D receptor (VDR) and MEGALIN (or LRP2)~     gene polymorphisms remains unclear, particularly among African-American adults. The~     associations of single nucleotide polymorphisms (SNPs) for VDR [rs1544410(BsmI:G/A),~     rs7975232(ApaI:A/C), rs731236(TaqI:G/A)] and MEGALIN [rs3755166:G/A,rs2075252:C/T,~     rs2228171:C/T] genes with incident and prevalent metabolic disturbances, including obesity,~     central obesity and metabolic syndrome (MetS) were evaluated.~      From 1,024 African-Americans participating in the Healthy Aging in Neighborhoods of Diversity~     across the Life Span (HANDLS, Baltimore, MD, 2004-2013) study, 539 subjects were selected who~     had complete genetic data as well as covariates selected for metabolic outcomes at two~     consecutive examinations (visits 1 and 2) with a mean follow-up time of 4.64±0.93y. Haplotype~     (HAP) analyses generated polymorphism groups that were linked to incident and prevalent~     metabolic disturbances.~   "
21972|NCT03279419|"~     This is a feasibility study, to assess if thermal imaging and/or near infrared imaging will~     be useful in identifying changes in the peripheral circulation in patients with different~     stages of liver disease.~      The aim of this study is to use new and advanced thermal imaging techniques to identify~     changes in the peripheral circulation and hand temperature in patients with liver disease.~     These changes could be used as a non-invasive marker of the severity and progression of liver~     disease. Thermal imaging will also be used to assess the changes in the peripheral~     vasculature with the use of terlipressin, a drug used as treatment for specific complications~     of liver disease.~      Patients with acute or chronic liver disease from any aetiology will be recruited, along with~     patients without liver disease as healthy controls. Patients with disease or on drugs known~     to affect the peripheral vasculature will be excluded.~      All studies will be performed in a ward setting in the Royal Infirmary of Edinburgh. The~     subjects will be required for up to three sessions, each lasting 30 minutes. The session will~     involve static thermal images being taken, and video images of the hands warming up after~     being cooled for 30 seconds in water at a temperature of 7 degrees Celsius. If the patient is~     receiving terlipressin therapy, static images will be taken before, during and after~     terlipressin therapy.~   "
21973|NCT03279406|"~     The objective of this observational non-randomized multicenter study is to compile real-world~     clinical characteristics and outcomes data for patients treated with LAA (left atrial~     appendage) closure systems in a daily clinical setting.~   "
22341|NCT03274596|"~     The retinopathy of prematurity (ROP) is a public health problem, the main causes of ROP are~     prematurity, use of oxygen, malnutrition and oxidative stress. Vitamin E was used beforehand~     however its use was stopped because of its association with sepsis and enterocolitis caused~     by the excipient of vitamin E. The purpose of this study is to use vitamin E to prevent ROP,~     without the previously used excipients.~   "
21974|NCT03279393|"~     Project 3 of the PPG grant Stress and Atherosclerotic Plaque Macrophages A Systems Biology~     Approach, funded by the NHLBI, examines the relationship between psychosocial stress and~     atherosclerotic inflammation, cell proliferation and burden using novel PET/MRI. Individuals~     with post-traumatic stress disorder, trauma controls and healthy controls will be recruited~     into a two center clinical study. The study team will use functional MRI to examine the~     relationship between activation of fear circuits in the brain and relate these data to~     hematopoietic system activation, and vascular inflammation measured by FDG-PET, and~     atherosclerotic burden measured by MRI.~   "
21975|NCT03279380|"~     Athlete status is a heritable trait that could be explained with a number of potentially~     important DNA polymorphisms contributing to predisposition to success in certain types of~     sport.~      The first aim of the study is to determine the genetic profile of Slovenian athletes. The~     associations of 30 common gene polymorphisms with aerobic and anaerobic athlete status will~     be investigated as a single and polygenic profile.~      The second aim is to investigate the impact of the genetic variants contributing to different~     acute response to low vs. high intensity exercise. Physiological and biochemical measurements~     will be carried out. Variability in physiological adaptation in response to exercise will~     provides an opportunity to study the relationship between the molecular response to exercise~     and the extent of physiological changes in athletes. Currently, it is not yet clear whether~     different genetic variant associated with exercise responses remains uniform, with different~     exercise intensities, structure and duration of exercise.~   "
21976|NCT03279367|"~     This study aims to explore if objective brain responses to speech stimuli (words and running~     speech) can be used to evaluate hearing aid fitting in adults. Objective brain responses~     would be beneficial, as they could be used to evaluate hearing with people who are incapable~     or unwilling to provide subjective responses. The study aims to determine if EEG responses to~     speech sounds are sensitive to the effects of hearing aids for hearing aid users. Secondary,~     the study will look into the need for using speech stimuli in order to obtain more robust~     responses compared to current clinical standards.~      The research questions addressed are as follows~        1. Are speech-evoked objective brain responses sensitive to hearing aid amplification?~        2. Are speech-evoked brain responses sensitive to distortions in speech and can hearing aid~          amplification resolve issues with brain responses to distorted speech?~        3. Which tests are optimal for detection of objective brain responses to speech?~        4. Are realistic speech stimuli (words or running speech) able to robustly detect brain~          responses compared to current clinical standards (clicks and tones)? The study will be~          carried out on a group of mildly to moderately hearing impaired subjects between the age~          of 18 and 70. Subjects will be recruited from the Royal Berkshire NHS Foundation Trust,~          where the research will be conducted. Participants will have their hearing function and~          hearing aid fitting checked as described in the design and methodology section of this~          proposal. During the experiment, participants will be asked to listen to speech sounds~          presented from a loudspeaker at comfortable listening levels. The responses will be~          measured with the participant wearing and not wearing hearing aids. Additionally,~          participants will perform a behavioural task for perception of speech. Participants will~          be asked to attend 2 sessions of 2 hours. Data collection will run over 1 year.~   "
21977|NCT03279354|"~     Building upon our previous groundwork including the development of the FAMILY MOVE app and~     the pilot study, we will further evaluate the effectiveness of a simple parent-child partner~     exercise programme delivered by our FAMILY MOVE app on children's health-related quality of~     life through a single blinded randomized placebo-controlled trial (RCT). This RCT will sample~     286 low-income parent-child pairs recruited from low income families in the community. Study~     participants will be randomized after baseline assessment by an independent statistician~     using computer randomization tool with 1:1 allocation ratio to either the FAMILY MOVE app~     intervention group or the HK FitNuts app control group. After both groups have completed the~     intervention study and follow up measurements at 1 month, 6 months and 12 months after~     intervention, the control group will receive the same FAMILY MOVE app. Outcome assessments~     will be conducted by a trained interviewer blinded to the subject group allocation at~     baseline, 1 month, 6 months and 12 months after intervention.~   "
21978|NCT03279341|"~     This study aim was to evaluate the effect of pharmacological treatments normally used to~     treat functional constipation and in particular PEG, bisacodyl and prucalopride on colonic~     motility as assessed by high-resolution manometry.~   "
21979|NCT03279328|"~     This proposed project will be an open-label, split face, randomized controlled pilot study.~     Up to 60 patients with diffuse facial actinic keratosis will be enrolled in the study. The~     purpose of this study is to understand the change in skin appearance throughout 5-FU~     treatment course and to examine whether a topical corticosteroid and moisturizer can decrease~     severity and duration of skin inflammation after 5-FU treatment course.~   "
21980|NCT03279315|"~     A 4-week study was conducted in 25 Chinese euthyroid women. Unified diets with different~     iodine contents (cooked with non-iodized salt or iodized salt) were provided in two different~     periods. The total iodine intake from diet, water and air as well as the total iodine~     excretion by urine, faces and respiration were monitored and determined, and a total of 300~     samples were collected. The sweat iodine loss was also considered. Moreover, the regression~     curve model between the 24-h iodine intake and 24-h iodine excretion was also established.~   "
21981|NCT03279302|"~     The primary objective of the trial is to characterize the pharmacokinetic (PK) profiles of~     glepaglutide and its primary active metabolites following once-daily and once-weekly~     subcutaneous (SC) injections and after a single intravenous (IV) infusion in healthy~     subjects.~      Glepaglutide is a proposed International Nonproprietary Name for ZP1848~   "
21982|NCT03279289|"~     The purpose of this study is to assess the efficacy and safety of treatment with~     FOLFIRI-aflibercept compared to initial treatment with FOLFIRI-aflibercept (for 6 cycles)~     followed by maintenance with 5FU-aflibercept, in an elderly population with metastatic~     colorectal cancer (mCRC) after failure of an oxaliplatin-based regimen~   "
21983|NCT03279276|"~     There have been no previously published clinical randomized studies comparing Primoris®,~     short stem, hip prosthesis with standard uncemented hip arthroplasty in relation to bone~     density and function development. This is the subject for this study.~   "
21984|NCT03279263|"~     This Phase 2, multi-center, double-blind, randomized, placebo-controlled, parallel group,~     add-on study of MLR 1023 in adults with uncontrolled T2DM on metformin anti diabetic~     monotherapy is designed to evaluate the efficacy and safety of MLR 1023 in combination with~     metformin in subjects with uncontrolled T2DM.~   "
22025|NCT03278730|"~     Meta-and ortho-Tyrosine are known markers of oxidative stress, while the physiological~     isomer, para-Tyrosine is suggested the antagonize the effects of meta- and ortho-Tyrosine.~     The changes in the serum levels of meta- and ortho-Tyrosine have been found to be paralel to~     that of the common sepsis markers. The hypothesis of the study is, that supplementation of~     para-Tyrosine (p-Tyr) in the early phase of sepsis may diminish some specific inflammatory~     procedures and thus may have a favourable impact on the disease progress, and consequently on~     the mortality.~   "
21985|NCT03279250|"~     The goal of this clinical research study is to learn if adding abiraterone acetate and~     standard of care prednisone to the combination of apalutamide and a standard type of drug~     called an LHRH agonist can help to control prostate cancer when given before surgery. The~     safety of these drug combinations will also be studied.~      This is an investigational study. Apalutamide is not FDA approved or commercially available.~     It is currently being used for research purposes only. The combination of abiraterone~     acetate, LHRH agonists, and prednisone is FDA approved and commercially available for the~     treatment of metastatic castration-resistant prostate cancer (mCRPC). Both drug combinations~     being used in this study are considered investigational.~      Up to 66 participants will be enrolled in this study. All will take part at MD Anderson.~   "
21986|NCT03279237|"~     This research study is studying a combination of interventions as a possible treatment for~     gastroesophageal (GE) junction cancer.~      The interventions involved in this study are:~      -FOLFIRINOX which is made up of 4 different drugs:~        -  5-Fluorouracil (5-FU)~        -  Oxaliplatin~        -  Irinotecan~        -  Leucovorin~        -  Paclitaxel~        -  Carboplatin~        -  Proton Beam Radiation Therapy~   "
21987|NCT03279224|"~     Every human harbors complex microbial communities (collectively, the human 'microbiome') that~     cover the skin and the body's mucosal surfaces. There is mounting evidence of an interaction~     between the intestinal microbiota, the gut, and the central nervous system (CNS) in what is~     recognized as the microbiome-gut-brain axis. Based on this compelling body of evidence, there~     is growing enthusiasm for work that is focused on translating this emerging association into~     novel therapies for psychiatric illness.~      Fecal microbiota transplantation(FMT) is a technique in which gut bacteria are transferred~     from a healthy screened donor to a patient, with the goal to introduce or restore a stable~     microbial community in the gut.There are no clinical trials examining the impact of FMT on~     Bipolar Disorder (BD). However, there is biological rationale to support this type of~     treatment, given the known inflammatory underpinnings of this illness.~      The objective of this study is to assess the effectiveness of this very novel therapy~     targeting the gut-brain axis, FMT, to treat bipolar depression.~      Study Hypotheses:~      Main hypothesis: FMT from healthy donors to patients with BD depression will improve~     depression symptoms as an adjunct to approved medication.~      Secondary hypotheses:~        1. FMT will also reduce anxiety and global function~        2. FMT is safe and will be well tolerated by the patients~        3. Improvements in clinical parameters will be associated with specific changes in the~          intestinal microbiome and/or metabolites in stool and serum~   "
21988|NCT03279211|"~     The main goal of the study is to determine true ileal amino acid digestibility of whey~     protein isolate (WPI) and zein proteins in healthy subjects equipped with naso-ileal tube.~     The endogenous losses of proteins and amino acids will be determined by collecting digesta~     samples after a protein-free diet in a third group of subjects.~   "
21989|NCT03279198|"~     This study compares the efficacy (adherence and stage) of four interventions to promote~     colorectal (CRC) and breast cancer (BC) screenings among women ages 50 to 75. They are:~        1. usual care;~        2. a TIWeb (tailored intervention Website)~        3. a CSC (cancer screening call) and~        4. TIWeb + a CSC. This study also compares the cost-effectiveness of the 4 interventions to~          promote CRC and BC screening among women ages 50 to 75.~   "
21990|NCT03279185|"~     This is a prospective cohort study designed to define the impact of HIV infection and~     antiretroviral therapy (ART) on young adults with perinatal HIV infection as they transition~     to adulthood.~   "
21991|NCT03279172|"~     The aim of the study was to compare intraocular pressure, intubation time, throat pain and~     hemodynamic variables using direct or videolaryngoscopy under general anesthesia requiring~     endotracheal intubation~   "
21992|NCT03279159|"~     Aim of the study was to evaluate by non-invasive instrumental evaluations tolerance and~     hydrating activity of a face topic product, to be applied twice a day, morning and evening,~     for an uninterrupted period of 8 weeks, by volunteers of both sexes, aged 45-60, who meet the~     inclusion and exclusion criteria required by the study procedure .~      It was also aim of this study to evaluate the hydrating activity of a single product~     application on the skin damaged by repeated stripping corneum (short term evaluation versus~     untreated control area).~   "
21993|NCT03279146|"~     This is a Phase 1 study to evaluate the PK profile of TXL oral formulations in healthy~     subjects~   "
21994|NCT03279133|"~     The prevalence of Hepatitis C Virus (HCV) infection was reported to range between 10% and up~     to 30% prior to institution of routine HCV screening in recipients of HCT (hematopoietic cell~     transplantation). In an Italian prospective study 6% of HCT candidates were positive for HCV~     RNA. HCV in recipients of HCT carries both short-term and long-term consequences. In the~     short-term those with HCV after hematopoietic cell transplantation have been associated with~     risk for sinusoidal obstruction syndrome especially in patients with some level of hepatic~     dysfunction going in to the transplant. In addition, the type of conditioning chemotherapy~     (e.g., busulfan) and radiation may increase risk for sinusoidal obstruction syndrome. The~     rate of hematopoietic recovery was found to be lower in HCV infected recipients, with delayed~     neutrophil and platelet engraftment.~      In the long-term, HCV may flare up once immunosuppression is being tapered off. The issue of~     reactivation of viral hepatitis (HBV and HCV) after HCT has been well documented. The risk~     for HCV reactivation in allogenic HCT in one study was reported at 100% by 12 months after~     HCT, with risk for death related to HCV of 8%. Also, of concern is rapid progression of liver~     disease in long-term survivors of HCV+ HCT. In such patients, cumulative incidence of~     cirrhosis has been reported in up to 11% and 24% at 15 and 20 years after HCT respectively.~      Hepatitis C infection is associated with significant morbidity and mortality, due to the~     short-term and long-term complications associated with it. Treatment of hepatitis C virus~     with direct-acting antiviral (DAA) agents pre-hematopoietic cell transplantation (HCT) in~     candidates with hepatitis C may lead to reduction of both short-term and long-term~     complications from it.~      Treatment with DAA's pre-HCT in candidates with hepatitis C would potentially prevent~     complications of hepatitis C infection; prevent reactivation of hepatitis C post-HCT, prevent~     delay in hematopoietic recovery (especially neutrophils and platelet), possibly reduce risk~     for sinsusoidal obstruction syndrome, prevent relapse of malignancy that could be related to~     hepatitis C (non-Hodgkin lymphoma), reduce non-relapse mortality and long-term complications~     (cirrhosis).~   "
21995|NCT03279120|"~     This multi-center Phase I study is designed to characterize the safety, PK, and PD of TFV/LNG~     IVR to assess systemic and genital tract bioavailability in healthy women. The IVRs to be~     used in the study are TFV/LNG IVR (8-10mg per day/20μg per day) or placebo IVR. Samples will~     be obtained before, during and after 90 days of continuous or interrupted IVR use.~   "
21996|NCT03279107|"~     The aim of the study is to describe the glycemic, insulinemic and appetitive responses to~     liquid and solid foods where either soluble fiber or maltodextrin are used as the~     carbohydrate substrate.~   "
22026|NCT03278717|"~     ICON 9 will assess the efficacy, safety and tolerability of maintenance olaparib in~     combination with cediranib compared to maintenance olaparib alone following a response to~     platinum-based chemotherapy in women with relapsed platinum-sensitive ovarian, fallopian tube~     or peritoneal cancer. Prognostic and predictive factors will be studied from tumour and blood~     samples.~   "
21997|NCT03279094|"~     This is a study to evaluate the safety and toxicity of a treatment regimen consisting of 2~     cycles of pre-transplant immunosuppressive therapy followed by myeloablative preparative~     regimen and allogeneic hematopoietic stem cell transplantation from a haploidentical donor in~     patients with sickle cell disease.~      The overall goal of this study is to expand the donor pool for hematopoietic stem cell~     transplantation in sickle cell disease using haploidentical donors, and to develop a~     non-toxic, myeloablative regimen, with the goal of achieving a consistent donor chimerism~     utilizing pre-transplant immunosuppressive therapy.~   "
21998|NCT03279081|"~     The purpose of this phase III, randomized, double blind, parallel group, placebo controlled,~     international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic~     expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s)~     in patients with Crohn's disease over a period of 24 weeks and a follow-up period up to 52~     weeks. ADMIRE-CD II study~   "
21999|NCT03279068|"~     Cesarean section is one of the most common surgeries performed with the intention of~     optimizing maternal and fetal/neonatal outcomes. One of the major indications for cesarean~     delivery is non-reassuring fetal status (NRFS). Electronic fetal monitoring is used to~     evaluate and manage women while they are in labor. A fetal heart rate tracing is recorded on~     paper or electronically and produces a pattern to allow physicians to visually identify~     fetuses that are at risk for hypoxia and/or acidemia. This practice allows for prompt~     intervention via intrauterine resuscitation and expedited delivery if deemed necessary.~     National and international guidelines published by the International Federation of Gynecology~     and Obstetrics and American College of Obstetrics and Gynecology describe how fetal heart~     rate patterns obtained with electronic fetal monitoring should be interpreted and managed. In~     order to interpret fetal heart rate patterns, the ability to visualize a pattern is~     necessary. This is made possible either by using paper on which the fetal heart rate is~     recorded or electronic screens with recording systems. In hospitals where continuous fetal~     heart rate monitoring is available, but paper resources are depleted and electronic screens~     are not available, an image of the fetal heart rate pattern cannot be produced nor~     interpreted. Thus, electronic fetal monitoring is used as an incomplete tool has become~     standard of care for laboring patients.~      Historical Western data revealed that implementation of continuous fetal monitoring with~     pattern interpretation increased rates of cesarean delivery in comparison to intermittent~     auscultation. However, it is not clear if the inability to interpret a pattern (because of a~     lack of paper or electronic recording) results in increased or decreased cesarean rates in~     comparison to pattern interpretation. It is possible that the implementation of pattern~     interpretation could decrease cesarean delivery rates allowing increased or earlier~     opportunity for fetal resuscitation for patients with tracing abnormalities which may avert~     cesarean delivery. The investigators' aim is to assess cesarean delivery rates using~     electronic fetal monitoring with versus without pattern interpretation in a hospital in a~     low-middle income country where resources are lacking.~      If a decrease in cesarean delivery rate is observed and/or neonatal outcomes are improved,~     this study may serve as an impetus to encourage electronic fetal monitoring paper-producing~     companies to subsidize or donate supplies to hospitals in developing countries. Ensuring that~     fetal status is in fact non-reassuring by fetal heart rate pattern interpretation prior to~     proceeding with cesarean delivery may decrease the cesarean delivery rate while not~     compromising fetal outcomes.~   "
22000|NCT03279055|"~     This research study is evaluating a six-session online program designed to help insomnia~     (difficulty falling or staying asleep) in adolescent and young adult cancer survivors.~   "
22001|NCT03279042|"~     This study aims to evaluate and compare the skeletal, dental and soft tissue changes, the~     levels of pain and discomfort and the effect on periodontal health and teeth vitality~     associated to traditional corticotomy and flapless corticotomy in the retraction of upper~     anterior teeth.~      40 patients requiring extraction of maxillary first premolars and maximum anchorage to~     retract the upper anterior teeth will participate in the study. They will be divided randomly~     into two groups : flapless corticotomy (20 patients) and traditional corticotomy (20~     patients). Pre-retraction, corticotomy will be performed in the maxillary anterior segment.~     The skeletal, dental and soft tissue changes will be performed using lateral cephalometric~     radiographs which will be obtained pretreatment, pre and post en-masse retraction of the~     anterior teeth and we will also use the dental casts to evaluate the dental changes.~   "
22002|NCT03279029|"~     To investigate histological structure and molecular changes involved on the onset of AVD~     after left ventricular assist device (LVAD) implantation and to compare them with those of~     patients operated on for severe aortic regurgitation.~      Methods: Bridge-to-transplant patients with AVD post-LVAD implantation are included. Patients~     operated on for severe aortic regurgitation are included as control. Clinical and TTE data~     are compiled. Samples of aortic valve are collected at the time of the intervention.~     RNA-sequencing analysis is performed in LVAD patients and variations of gene expression are~     validated by real time qPCR in both. Blood sampling are performed pre-operatively and at~     one-month follow up to assess the plasma level of previously identified gene modulators.~     In-vitro studies exposing VICs and VECs to several mechanical stimuli are performed for~     validation.~      Conclusion(s) Taking together, the in-vivo and in-vitro models would provide important~     information for the understanding of valve remodeling and disease. ECM gene modulators could~     represent pertinent molecular targets to stop the progression of AVD~   "
22003|NCT03279016|"~     To detect accuracy of serology in diagnosis of temporomandibular joint arthritis.~   "
22004|NCT03279003|"~     Light-emitting diode (LED) light therapy is increasingly used successfully and without~     adverse effects in diabetic leg ulcer, chronic low back pain, chronic myofacial pain in the~     neck and in several dermatoses such as acne, Psoriasis, alopecia areata and skin~     rejuvenation. A Korean study conducted in 2013 suggested its effectiveness in patients with~     sensitive skin in connection with rosacea, acne, eczema. The objective of the study is to~     perform a study in subjects with a sensitive skin without associated dermatosis.~   "
22016|NCT03278847|"~     The overarching aim of this project is to determine the optimum enteral and parenteral~     nutrition strategy for newborns with Hypoxic Ischaemic Encephalopathy (HIE) during and after~     therapeutic hypothermia. To do this the investigators will perform two primary comparisons:~        1. ENTERAL: to determine whether any enteral (milk) feeding, when compared to withholding~          enteral feeding (no milk), during therapeutic hypothermia, is associated with a~          difference in the incidence of necrotising enterocolitis.~        2. PARENTERAL: to determine whether provision of intravenous dextrose, when compared to~          provision of parenteral nutrition, during therapeutic hypothermia, is associated with a~          difference in the incidence of blood stream infection.~      The investigators will use de-identified data held in an established research database called~     the National Neonatal Research Database (NNRD) and we will use the potential outcomes~     framework with application of propensity scoring to define matched subgroups for comparison.~   "
22059|NCT03278288|"~     The study evaluates the effectiveness of the WellWe-intervention in promotion of parental~     self-efficacy for healthy behaviors and mindfulness in parenting from the perspective of~     families. Aim is also to evaluate the effectiveness of the WellWe-intervention in~     facilitation of family-centered approach of the health visit in Child health clinic perceived~     by the families and Public health nurses (PHN). Half of the participants will receive~     WellWe-intervention and half of the participants will receive usual care.~   "
22005|NCT03278990|"~     Pre-exposure prophylaxis, or PrEP, is a relatively new HIV prevention method where~     individuals who are at risk for HIV but do not currently have it take a daily pill (Truvada).~     PrEP has been proven medically effective and could help to reduce the rate of new HIV~     incidence in the United States, but in five large, randomized and controlled studies, many~     prospective PrEP patients chose not to take PrEP, and those that did often did not adhere to~     it consistently. How do we increase PrEP uptake and adherence amongst those most at risk for~     HIV? Also, will taking PrEP increase or decrease high-risk individual sexual behavior and HIV~     incidence? Here, the investigators propose a parallel group randomized, controlled clinical~     trial to test the effectiveness of a behavioral intervention designed to buffer individuals~     against stigma-related feelings, and to increase their connection to their selves twenty~     years in the future. The primary objective of the study is to increase PrEP adherence, as~     measured by the concentration of tenofovir diphosphate (TFV-DP) in dried blood spot samples~     (DBS). The secondary objectives are to decrease the incidence of STIs and increase safe~     sexual practices, as measured by clinic diagnoses and self-reported practices at 3, 6, 9 and~     12 months.~      This 12-month outpatient study will take place at four PrEP clinics in Pittsburgh and will~     enroll 170 subjects across 4 sites, with an expectation of retaining 80%, or 135 subjects.~     Eligibility includes male and female adults, ages 18-65, who are at risk of contracting HIV.~     Efforts will be made to recruit 33% of subjects from each of the following strata: 1) young,~     minority LGBT adults age 18-30 years of age; 2) Caucasian adults (MSM and heterosexual~     females) age 18-65 years of age; and 3) IDU adults, age 18-65, of any ethnic background.~   "
22006|NCT03278977|"~     Apparent Life-Threatening Events (ALTE) in infants often lead to severe neurological~     complications or to sudden death. In such situations, cardio-pediatricians and intensive care~     physicians have no specific diagnosis or treatment. In a recent translational research~     (INSERM-DHOS), our team has reported a myocardiac abnormality in a rabbit model of vagal~     hyperreactivity which is also present in the human hearts of infants deceased from sudden~     death, i.e. increased M2 muscarinic receptors (M2R) density associated with compensative~     increased enzymatic activity and overexpression of acetylcholine esterase (AchE). In a recent~     PHRC-I study (article in preparation), these abnormalities have also been observed in the~     blood of patients, infants as well as adults, exhibiting severe vagal syncopes. We observed,~     even more importantly, similar abnormalities in infants under 1 year of age with very severe~     idiopathic ALTE (iALTE) compared with normal subjects and with patients who presented ALTE~     with identified etiologies (JAMA Pediatric, 2016 May). The aim of this present study is to~     validate the overexpression of M2R as a marker of risk of iALTE in infant under 1 year.~   "
22007|NCT03278964|"~     Randomized prospective clinical trial, aiming to compare two techniques of orbital~     decompression. Patients with Graves orbitopathy in the inactive phase for at least 6 months~     will be divided in two groups; one group will be submitted to orbital decompression by~     antro-ethmoidal technique; the other group will be submitted to orbital decompression by~     lateral wall technique. Patients will be followed up for a period of 6 months after the~     surgery, and will be evaluated about the effect of orbital decompression on ocular motility,~     proptosis, ocular surface and quality of life.~   "
22008|NCT03278951|"~     The purpose of this study was to determine how 12 weeks of health coaching with~     individualized feedback and education in combination with mobile health devices (a digital~     wireless body weight scale and wireless activity tracker) influences body weight, waist~     circumference, physical activity levels, and select blood-borne markers of health (fasting~     blood glucose, hemoglobin A1c, and insulin). The individualized health coaching, education,~     and feedback was delivered by either video conferencing or direct, in-person consultation.~     All education materials including (i.e. video modules, exercise manuals, nutrition manuals)~     were designed and compiled by a team of health professionals from (inHealth Medical Services,~     Inc.). These materials focused on incorporating behavioral principles of self-monitoring,~     exercise, nutrition, goal setting, and behavior modification. Each participant was randomly~     assigned into one of two intervention groups (a video conferencing or in-person group) or a~     control group.~   "
22009|NCT03278938|"~     Depressed patients unremitted after monotherapy with citalopram or bupropion will remit~     following six weeks treatment with the combination of citalopram and bupropion.~   "
22010|NCT03278925|"~     This phase I trial studies the side effects and best dose of defined green tea catechin~     extract and to see how well it works in preventing liver cancer in patients with cirrhosis.~     Higher levels of the molecule gamma-OHPdG may be found in patients with cirrhosis, which may~     mean a higher risk of the development of liver cancer. Defined green tea catechin extract may~     work better to lower levels of gamma-OHPdG and prevent the development of liver cancer.~   "
22011|NCT03278912|"~     Background:~      PIDD stands for primary immune dysregulation. It is a general term that includes many~     different inherited immune system disorders. The immune system is the part of the body that~     helps fight disease and infection. People with PIDDs can develop many kinds of health~     problems. One of these is inflammatory bowel disease (IBD), which causes diarrhea and~     cramping. Researchers want to learn more about these disorders to develop possible~     treatments.~      Objective:~      To learn more about when and why IBD may develop in some people with PIDDs.~      Eligibility:~      People ages 3 and older who have PIDD or IBD.~      Healthy volunteers in this age group are also needed.~      Design:~      Visit 1: Participants will be screened with physical exam, medical history, and blood and~     urine tests.~      Visit 2: Participants will:~        -  Have more physical exams and blood and urine tests.~        -  Answer questions about quality of life and food history.~        -  Provide a stool sample.~        -  Have nasal and rectal skin swabs.~        -  Have saliva collected.~      Participants will have 1 follow-up visit per year. They will repeat visit 2 procedures.~      Participants will be contacted by phone or email in between yearly visits. They will be asked~     about their health. They will complete a quality-of-life questionnaire and send a stool~     sample that is collected at home.~      If participants experience a sudden change in symptoms or undergo a new treatment, they may~     be asked to complete visit 2 procedures.~      If participants are not able to come to NIH, study data and samples can be collected without~     an in-person visit.~      Participants will have a final study visit about 10 years after Visit 1. They will repeat~     visit 2 procedures.~   "
22012|NCT03278899|"~     This is a non-interventional, multi-center study that follows general principles of periodic~     assessment of X-ALD patients in routine practice. No study drug treatment will be given and~     no changes to patient treatment are necessary.~   "
22017|NCT03278834|"~     Objectives: The acute care of pelvic fractures has improved recently however there are no~     formal guidelines for rehabilitation of these types of fractures. Patients have long periods~     of non-weight bearing causing muscle wastage. Neuromuscular electrical stimulation (NMES) has~     proven to minimise muscle loss. However, this has not previously been investigated within~     this patient population.~      Design: Double blind, randomised, feasibility study.~      Setting: NHS trust hospital setting.~      Participants: Nine patients with surgically fixed pelvic fractures were randomly allocated at~     six weeks post fracture.~      Interventions: The intervention group completed six weeks of NMES. The placebo group used~     transcutaneous electrical nerve stimulation (TENS).~      Main outcome measures: Peak torque (Nm) was calculated in the operated limb at 12 weeks using~     the non-operated limb as a baseline. Compliance and intensity levels were recorded.~     Feasibility of NMES was evaluated using a feasibility questionnaire. Pain was measured at six~     and 12 weeks using a visual analogue scale (VAS).~   "
22018|NCT03278821|"~     The purpose of this study is to determine whether patient self-matching (as compared with~     treatment as usual by expert matching) improves quality of life, retention, and outcome for~     patients being treated for alcohol problems.~      There are at least two good reasons for offering patients a choice when the goal is a change~     in their behavior. The first is that patients are likely to know what treatment works best~     for them. Secondly, being allowed to choose between options may increase compliance in~     treatment. As a randomized controlled trial, this study will compare the efficacy of patient~     self-matching versus treatment-as-usual expert matching.~      The Self-Match Study is expected to increase knowledge on the importance of involving the~     alcohol dependent patient in choosing what treatment method is best for him/her instead of~     having experts to do that. The investigators expect to discover patient involvement as a way~     to improve compliance in treatment, hence preventing that patients drop out of treatment to~     early. If this hypothesis proves to be right, clinicians will have a viable strategy for~     matching treatment methods to patients, since the strategy does not demand further resources~     in the treatment system.~   "
22019|NCT03278808|"~     This is an open label, Phase 2 study with controlled human malaria infection (CHMI). Twenty~     three subjects will be enrolled into 2 groups (15 subjects in the Chloroquine-Azithromycin~     [CQ/AZ] Intervention Group, and 8 subjects in the Chloroquine [CQ] Group). The CQ/AZ Group~     will receive experimental intervention of 300 mg of CQ and 2 g of azithromycin (AZ). The CQ~     Group will receive 300 mg of CQ only. All subjects will participate in the CHMI and will be~     required to stay at a hotel for evaluation for a maximum of 14 nights starting 7 days after~     the challenge. A standard dose of atovaquone-proguanil (Malarone®) will be administered to~     all symptomatic parasitemic subjects under directly observed treatment.~   "
22020|NCT03278795|"~     Chronic Obstructive Pulmonary Disease (COPD) is a common, preventable and treatable disease~     that is characterized by persistent respiratory symptoms and airflow limitation that is due~     to airway and/or alveolar abnormalities usually caused by significant exposure to noxious~     particles or gases. Acute exacerbations may occur during the management of stable COPD which~     can negatively impact health status, rates of hospitalization and re-admission. During~     exacerbation, some patients need immediate admission to the respiratory intensive care unit~     (RICU) for ventilatory support. As prolonged mechanical ventilation has unfavourable impacts,~     it is Important to minimize the duration of mechanical ventilation and perform extubation as~     soon as possible. In recent years, development of numerous models of artificial respiration,~     which could support spontaneous breathing, has made it possible to gradually decrease the~     mechanical ventilatory support. From these new modes, PSV which is a well known weaning mode~     will be compared in our study to a new weaning mode which is a volume support ventilation~     (VSV).~   "
22021|NCT03278782|"~     The goal of this clinical research study is to learn if it is safe to give pembrolizumab in~     combination with romidepsin to patients with peripheral T-cell lymphoma or cutaneous T-cell~     lymphoma. Researchers also want to learn if the study drug combination can help to control~     the disease.~      This is an investigational study. Pembrolizumab is FDA approved and commercially available~     for the treatment of certain types of melanoma. Romidepsin is FDA approved and commercially~     available for the treatment of peripheral T-cell lymphoma and cutaneous T-cell lymphoma. The~     use of these drugs in combination with each other is investigational.~      The study doctor can explain how pembrolizumab and romidepsin are designed to work.~      Up to 33 participants will be enrolled in this study. All will take part at MD Anderson.~   "
22022|NCT03278769|"~     The present study is an explorative analysis of the relationship between cerebral blood~     perfusion and oxygenation and lung mechanical variables at different ventilator settings. It~     is a safety study excluding patients with severe lung injury or brain edema.~   "
22023|NCT03278756|"~     This study evaluates the effectiveness of an internet-delivered cognitive control training as~     a preventive intervention for remitted depressed patients. Half of the participants will~     receive a cognitive control training, while the other half will receive a low cognitive load~     training that acts as an active control condition.~   "
22024|NCT03278743|"~     Studies have found a beneficial effect of tea consumption on the reduction of risk of~     cognitive impairment and dementia in older aged populations. However, there is a paucity of~     data on these associations in the very old defined as individuals aged 85 years and over.~     Therefore, we hypothesized that higher tea consumption was associated with better global and~     domain-specific cognitive function. We investigated the relationship between tea consumption~     in the very old and measures of global cognitive function, memory, attention and psychomotor~     speed.~      The Newcastle 85+ Study was a longitudinal (5-years), population-based cohort study of~     individuals aged 85+ years in North East England, United Kingdom. The final sample included~     676 community-dwelling and institutionalized men and women recruited through general medical~     practices.~      Baseline tea consumption was assessed through a 2x24-hr multiple pass recall and longitudinal~     measures of global and domain specific (memory, speed and attention) cognitive function~     through the standardized mini-mental state examination and the cognitive drug research~     system. Linear mixed models, controlling for demographic (e.g. age, sex and education) and~     health variables were used to determine whether tea consumption was protective against~     cognitive decline.~   "
22060|NCT03278275|"~     The aim of this non-randomised, prospective study is to investigate the applicability and~     prognostic value of uPAR PET/CT with the radioligand 68Ga-NOTA-AE105 in patients with~     neuroendocrine tumors (NETs).~   "
22027|NCT03278704|"~     It is recommended that individuals perform a combination of resistance exercise (RE) and~     endurance exercise. Lack of time is often cited as a reason for being unable to meet current~     exercise guidelines. Therefore, combining both forms in one session may be beneficial.~     However, research continues to elucidate whether interference of adaptive outcomes occurs~     when RE and endurance exercise are performed concurrently. A proposed interference effect~     suggests that concurrent training may dampen RE-induced adaptations (e.g., muscle strength~     and growth) compared to RE only.~      The propose of this investigation is to determine the effects of concurrent RE and~     high-intensity interval training (HIIT), compared to RE only, on muscle health and~     cardiovascular risk in sedentary, middle-aged (40-65 years) who are overweight/obese with~     type 2 diabetes mellitus (T2DM). The investigators will measure the effects on muscle~     strength, muscle growth, cardiovascular fitness, glycaemic control and markers of~     cardiovascular risk before and after an 8-week training program. Data will be obtained~     through the analysis of skeletal muscle samples, blood samples, magnetic resonance imaging,~     questionnaires and exercise performance tests.It is hypothesized that concurrent RE + HIIT~     will amplify the exercise-induced muscle growth response, which will result in greater~     satellite cell content, compared to RE alone. As a result, this will lead to greater skeletal~     muscle mass and strength after RE + HIIT compared to RE in isolation.~      A finding that concurrent resistance training and HIIT does not impede muscle adaptations~     could offer future strategies to minimize exercise time commitment whilst still maximizing~     the physiological benefits of both resistance and endurance exercise through a single~     training session. This may therefore provide an effective exercise strategy in the prevention~     and/or treatment of T2DM.~   "
22028|NCT03278691|"~     To determine is low-dose ketorolac use in the early post-operative period (within 48 hours)~     provides adequate analgesia without long term adverse effect on spinal fusion rates when~     compared to post-operative analgesia without the use of NSAIDs.~   "
22029|NCT03278678|"~     Hospital-based case management programs and home hospitalization services following the risk~     stratification model of Kaiser Permanente and Kings Fund select an estimated 5% of older~     individuals living in the community who are at high risk of hospitalization and adverse~     outcomes. The objective of these services is to avoid deterioration and hospital admissions~     or visits to the emergency services by regular follow-up, proactive home visits and support~     of self-care . The prevalence of malnutrition in patients selected using this model of care~     is unknown.~   "
22030|NCT03278665|"~     Phase Ib/II open-label, multi-center study with a priming cycle of 4SC-202 to evaluate the~     safety, tolerability and preliminary efficacy of combination treatment with 4SC-202 and~     Pembrolizumab. A dose expansion cohort at the Recommended Phase Two Dose (RPTD) will be~     added.~      Adult patients with advanced (unresectable or metastatic) cutaneous melanoma primary~     refractory or non-responding to anti-PD-1 therapy as most current systemic anti-cancer~     therapy and for whom no standard therapy is available, will be enrolled. The last~     administration of anti-PD-1 therapy must have been performed within 6 months prior to~     screening.~   "
22031|NCT03278652|"~     A prospective non-interventional study on the use of analgesic drugs in renal colic in~     emergency rooms~   "
22032|NCT03278639|"~     Gait deficits are among the most characteristic and most functionally debilitating signs of~     the motor neuropathology of Parkinson's disease (PD). Rhythmic Auditory Stimulation (RAS) is~     a technique by which a series of auditory stimuli are presented at a fixed rhythm, so that~     patients have to synchronize their movements to the rhythms. In this study, auditory stimuli~     will be constituted by Tango musical pieces, which tempo is modified to adapt to patients'~     walking cadence. Previous results suggested that RAS can increase Tinetti's gait and balance~     and may also improve Health-Related Quality of Life. This will be a randomized, blind,~     controlled clinical trial to further assess RAS efficacy and safety.~   "
22033|NCT03278626|"~     In this multi-institution phase I/II trial, the investigators have chosen paclitaxel and~     carboplatin using a schedule and doses identical to those used in the CROSS trial. Following~     a run-in with nivolumab alone at 240 mg IVPB every 2 weeks for 2 doses, nivolumab at 240 mg~     every 2 weeks will be added to paclitaxel and carboplatin, which will be dosed according to~     the standard of care established by the CROSS trial: paclitaxel 50 mg/m2 weekly for 6 weeks~     and carboplatin AUC 2 weekly for 6 weeks. Concurrent radiation will be administered with~     chemotherapy at 1.8 Gy/fraction × 28 fractions to a total dose of 50.4 Gy, the standard~     radiation dose administered in the United States for trimodality therapy that includes~     concurrent therapy with carboplatin and paclitaxel. A decrease in dose to 41.4 Gy per the~     protocol established by van Hagen, et al. will be permitted before discontinuing therapy due~     to unacceptable toxicity. While the CROSS study administered only 5 weekly doses of~     chemotherapy during the 5 weeks of radiation, the higher dose of 50.4 Gy (1.8 Gy/fraction ×28~     fractions over 5½ weeks) utilized in this study permits for a sixth dose during the~     additional week of radiation.~   "
22034|NCT03278613|"~     This study is a multi-center, randomized clinical trial of women with refractory accidental~     bowel leakage (ABL) symptoms who have failed to achieve satisfactory symptom control from 2~     first-line treatments for ABL: supervised pelvic muscle training (PMT) and constipating~     medication. The purpose of this study is to compare percutaneous tibial nerve stimulation~     (PTNS) to a validated sham to determine if PTNS is effective for the treatment of fecal~     incontinence (FI) in women.~      The investigators will test the null hypothesis that change from baseline in St. Mark's~     (Vaizey) score after 12 weeks of stimulation is not significantly different in women with~     symptomatic ABL receiving PTNS treatments compared to women receiving sham PTNS treatments.~   "
22035|NCT03278600|"~     This study is designed to evaluate the value of tissue-of-origin (ORIGIN-PanCA○R) profiling~     in predicting primary site and directing therapy in patients with cancer of unknown primary.~   "
22045|NCT03278470|"~     HL237 is a new autoimmune therapeutic agent for rheumatoid arthritis, including the basic~     structure of biguanide in metformin, an existing diabetes drug.~      The immune modulating activity of HL237 was demonstrated in animal model. HL237 is a STAT3~     inhibitor and STAT3 is well known for an important regulator inhibiting Th17 cells and~     activating Treg cells.~      Therefore, when STAT3 activity is inhibited, it is expected to be able to treat autoimmune~     diseases such as rheumatoid arthritis.~      This is the first clinical trial to be conducted for the development of HL237 and this~     clinical trial is for determining the maximum oral dose of HL237 and assessing safety,~     tolerability, and pharmacokinetic characteristics for each dose group.~   "
22046|NCT03278457|"~     The overall rationale is to reduce the risk of sudden cardiac death in individuals with~     hypertrophic cardiomyopathy (HCM). The novel approach of this study is to correlate Positron~     Emission Tomography (PET) findings to ventricular arrhythmias detected by the implantable~     cardioverter defibrillator (ICD). This could potentially lead to an improved risk~     stratification of HCM patients.~   "
22047|NCT03278444|"~     The purpose of this study is to evaluate the efficacy and safety of arginine hydrochloride~     combined with trimetazidine hydrochloride tablets in the treatment of patients with~     hepatocellular carcinoma.~   "
22036|NCT03278587|"~     The vast majority of blindness is avoidable. The World Health Organization (WHO) estimates~     that 80% of cases of visual impairment could be prevented or reversed with early diagnosis~     and treatment. The leading causes of visual impairment are cataract and refractive error,~     followed by glaucoma, age-related macular degeneration (AMD), and diabetic retinopathy (DR).~     Loss of vision from these conditions is not inevitable; however, identifying at-risk cases~     and linking cases with appropriate care remain significant challenges.~      Worldwide, eye health care systems must determine optimal strategies for reaching people~     outside of their immediate orbit in order to reduce visual impairment. Visual impairment can~     be reduced by case detection of prevalent disease like cataract and refractive error, or by~     screening for early disease like glaucoma, AMD, and DR and preventing progression. Systems~     around the world have developed numerous approaches to both case detection and screening but~     there is very little research to support the choice of allocating resources to case detection~     or screening and little data exists on the cost effectiveness of the various approaches to~     each.~      VIEW II Pilot is a cluster-randomized trial to determine the effectiveness of different~     approaches to community-based case detection and screening for ocular disease. Communities in~     Nepal will be randomized to one of four arms: 1) a comprehensive ocular screening program, 2)~     a cataract camp-based program, 3) a community health worker-based program, and 4) no program.~   "
22037|NCT03278574|"~     The study evaluates the results of mitral valve repair with flexible band in comparison with~     rigid ring in patients undergoing mitral valve repair for degenerative mitral valve disease~   "
22038|NCT03278561|"~     A cross-sectional study in asthma patients to determine if a late age of onset asthma (start~     symptoms >18 years old), is associated with more persistent airway/systemic inflammation,~     worse asthma control, more co-morbidity, a different microbiome and poorer quality of life~     despite the use of optimized asthma therapy.~   "
22039|NCT03278548|"~     The aim of the study is to investigate the safety of a 6% HES (Hydroxyethyl Starch) solution~     (Volulyte 6%) versus an electrolyte solution (Ionolyte) in patients undergoing elective~     abdominal surgery.~   "
22040|NCT03278535|"~     Three dimensional gait analysis is widely accepted as a general measure of functional ability~     among individuals as it is related to health, well-being and quality of life. To diagnose~     subtle changes/deviations in gait and to correctly interpret gait, a reference gait database~     of healthy subjects is required. Computer Assisted Rehabilitation Environment (Caren) is a~     new gait analysis system which combines the 3D motion captures system with a split belt force~     plate instrumented treadmill and a virtual reality environment. This system enables to~     analyses several successive steps, which is impossible in the standard overground~     laboratories. Until now, no reference gait database has been created using the Caren system.~     The aim of this descriptive study is to create a reference database of gait in healthy adults~     with varying subject characteristics using Caren. This study is a single center descriptive~     study to build a reference database on gait of healthy adults of different ages. Seven age~     groups are composed existing of ten male and ten female. Taken into account that 10% of the~     volunteers (especially elderly) may drop out due to e.g. disability, a total of 155 subjects~     will be recruited to ensure that database will include 140 subjects. Inclusion criteria:~     ambulatory, ability to walk without aid for 30 minutes, age older than 18years and willing to~     participate. Exclusion criteria: muscular skeletal, cardiopulmonary disorders or other~     diseases significantly influencing gait. Medical interventions, such as surgical treatment or~     botulinium toxin 6 months, which significantly influence gait. Subjects will walk at~     different walking speeds at Caren while gait is measured. Subjects always wear a safety~     harness to avoid falling. In addition adults wear standard shoes (gymnastic booties) provided~     by the lab to avoid shoes effects. All subjects undergo measurement of leg length, body~     length and body weight in order to retrieve anthropometric parameters. In addition a standard~     physical examination is performed to get information about a subjects' muscle strength,~     balance and articular mobility of the hip, knee and ankle. Gait kinematic, kinetic,~     spatio-temporal and balance parameters are measured.~   "
22041|NCT03278522|"~     Ramosetron is commonly used to prevent postoperative nausea and vomiting (PONV) in the~     Eastern Asia. The prolongation of QTc interval is a main side effect. In this study, the~     pre-treatment time of ramosetron to decrease PONV, and QTc prolongation is compared.~   "
22042|NCT03278509|"~     Long-term beta-blocker therapy has not been investigated in contemporary randomized clinical~     trials in patients with myocardial infarction and normal heart function. The aim of this~     study is to determine whether long-term treatment with oral beta-blockade in patients with~     myocardial infarction and preserved left ventricular systolic ejection fraction reduces the~     composite of death of any cause or new myocardial infarction..~   "
22043|NCT03278496|"~     Reinforcement-Based Therapy (RBT) is an intensive outpatient substance abuse treatment that~     includes relapse prevention skills training, goal setting, help with finding employment and~     abstinence-contingent rent payment for recovery housing in the community. It is meant to~     provide motivation for continued abstinence while enhancing social stability. In this study,~     treatment was offered to inner city opiate and cocaine users immediately following a brief~     medically-supported residential detoxification. Previous research had shown that RBT produces~     3- month outcomes superior to those for patients who are referred to outpatient treatment in~     the community. The present study compared outcomes for patients (N = 243) randomly assigned~     to receive abstinence-contingent recovery housing with (full RBT) or without additional~     intensive counseling or to receive usual care referral to outpatient treatment following~     detoxification. Outcomes were similar at 3- and 6-month follow-ups for those who received~     recovery housing with (full RBT) and without additional counseling and both these treatments~     were superior to usual care referral. Study findings support the efficacy of~     post-detoxification recovery housing with or without counseling for opiate and cocaine users.~   "
22044|NCT03278483|"~     Researchers will evaluate the efficacy, toxicity, adherence and cost effectiveness of~     treatment with isoniazid or rifampicin in patients with diabetes mellitus type two (DM2) and~     latent TB (LTB).~      This is a collaborative study with participation from three national institutes (Instituto~     Nacional de Salud Pública (INSP), Instituto Nacional de Enfermedades Respiratorias (INER) and~     the Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran (INCMNSZ)).~      The study will take place in the VII sanitary jurisdiction of Orizaba and the INCMNSZ that~     has the necessary infrastructure and human resources. Researchers will evaluate 3000 patients~     with diabetes using a standardized questionnaire and a tuberculin skin test (TST) test.~     Eligible patients will be invited to participate and from those that agree to participate and~     sign a written informed consent we will obtain clinical, epidemiological, nutritional and~     metabolic information. Patients with altered liver function tests will be excluded.~   "
22342|NCT03274583|"~     The aim of this study is to evaluate the reliability of smartphone seismocardiographic~     detection of AF in comparison to the gold standard of continuous telemetry ECG recording.~   "
22048|NCT03278431|"~     More than one billion people are infected with soil-transmitted helminths (STH, A.~     lumbricoides, hookworm or Trichuris trichiura). Preventive chemotherapy - i.e. annual or~     biannual treatment of at-risk populations with albendazole or mebendazole is the current~     strategy against STH. However, the efficacy of both drugs is only moderate against hookworm~     and low against T. trichiura. For increasing the efficacy and to avoid drug resistance, new~     drugs or the combination of different drugs is the way forward.~      In this randomised controlled trial, we assess the efficacy (based on cure rates) of~     different drug combinations in school-aged children in Lao. 420 hookworm positive children~     will be treated: 140 with albendazole-oxantel pamoate, 140 with albendazole-pyrantel~     pamoate-oxantel pamoate treatment arms, 70 with pyrantel pamoate-oxantel pamoate and 70 with~     mebendazole-pyrantel pamoate-oxantel pamoate. Two stool samples will be collected at baseline~     and follow-up (14-21 days after treatment) and analysed with Kato-Katz.~   "
22049|NCT03278418|"~     Patients elected to undergo any type of left-sided valve surgery (either repair or~     replacement) with non severe tricuspid regurgitation and tricuspid annular dilation will be~     screened. Consenting patients fulfilling all inclusion and exclusion criteria will be~     included in the study and assigned to elective left-sided valve replacement or repair with or~     without concomitant tricuspid valve repair in a 1:1 fashion, using a blocked randomization~     scheme balanced within center.~   "
22050|NCT03278405|"~     This is a single-center, single-arm, open-label, pilot trial to evaluate the efficacy and~     safety of avelumab in subjects with unresectable or metastatic, Grade 3,~     poorly-differentiated neuroendocrine.carcinoma.~   "
22051|NCT03278392|"~     This study seeks to understand how a mother's emotional state in pregnancy influences her~     biological response to food intake.~   "
22052|NCT03278379|"~     This is a single-center, single-arm, open-label, phase II trial to evaluate the efficacy and~     safety of avelumab in subjects with unresectable or metastatic, Grade 2-3,~     well-differentiated neuroendocrine.tumour.~   "
22053|NCT03278366|"~     The purpose of this study is to assess changes in benchmark and state assessment scores in a~     public elementary school following an intervention of dance integration into the daily~     routine of the classroom. Furthermore, this study aims to assess if dance may improve student~     behavior, teacher perception of student behavior, reading level and attendance.~   "
22054|NCT03278353|"~     A total of 63 participants will be recruited through 3 local surgeons in Durham, North~     Carolina after distinctive differential diagnostic methods, all with extensive expertise in~     intra-articular hip pathology and arthroscopy. The surgeons will offer the opportunity to~     participate in the trial by providing information to the recipient. Potential participants~     that do not contact project team members will be contacted by phone if they do not respond to~     the initial invitation. Potential participants will be initially screened by telephone~     interview, followed by a clinical examination to confirm study eligibility. The blinded~     researchers will obtain informed consent and will perform outcome assessments~      Purpose of the Study: 1) measure the mediating effect of baseline patient expectations on~     fulfillment of expectations (for both conservative care and surgery, measured at 6 weeks and~     at 1 year respectively) in a cohort of patients with a diagnosis of FAI Syndrome who receive~     six weeks of conservative physical therapy intervention and 2) measure the effect of baseline~     expectations on patient reported outcomes (e.g., HAGOS, pain, global rating of change) at six~     weeks.~   "
22055|NCT03278340|"~     Comprehensive approaches that combine sun protection policy and education for outdoor workers~     can reduce their risk for skin cancer by reducing their exposure to solar ultraviolet~     radiation on the job. To effectively disseminate the investigators' evidence-based sun~     protection policy and education intervention, Sun Safe Workplaces, a balance of effectiveness~     and cost of scale-up methods is required. The investigators propose to translate the~     intervention using a technology-based delivery method and compare the cost effectiveness of~     the original intervention and the intervention delivered by technology in a study that models~     national distribution strategies to public safety and public works sectors.~   "
22056|NCT03278327|"~     Barrett's oesophagus is a transformation of the esophageal mucous membrane there intestinal~     metaplasia under the effect of gastro- esophageal reflux disease (GERD).~      This metaplasia can evolve in low grade dysplasia LGD) , high grade dysplasia (HGD) then~     invasive adenocarcinoma.~      The treatment of the HGD of the Barrett is the endoscopic treatment. It is about a~     superficial treatment of tumor without ganglionar invasion by definition.~      The endoscopic treatment of the Barrett began in the 2000s, and showed its long-term~     efficiency.~      The studied factors of recurrences are the length of the Barrett, the influence of the~     eradication completes of the Barrett besides the eradication of the dysplasia, as well as the~     duration of spacing of the procedures. An anatomical zone is particularly delicate to treat.~     It is about the anatomical junction between the oesophagus and the stomach appointed junction~     oeso-gastric or cardia or line Z.~      This almost virtual zone is the site of most of the recurrence. The first cause of the~     oesophagus of Barrett and of its transformation in HGD is the reflux.~      This reflux can be handled by medicinal action inhibitor of the pump with proton (PPI) or by~     surgery (hemi-fundo plicator). This reflux is probably the cause of the long-term recurrence~     found in the literature.~      The surgery is a good treatment of the reflux with however unsatisfactory long-term results.~     On the other hand, the surgery is little used after endoscopic treatment of a HGD not to~     compromise the surveillance and the detection of a second offense potentially masked in the~     surgical fundo-plicator. The endoscopic treatment of the expensive ebb because of the based~     necessary material too on a fundo-plicator is complicated with use in reason also of his~     cost.~      The medical treatment by PPI for life, besides his duration and thus the potential hardness~     for the patient, presents long-term complications recently described.~      Effects on the appearance of gastric precancerous lesion is not certain, but this association~     with an osteoporosis is more proved true.~      The PPI could also be a etiologic factor of chronic renal insufficiency and insanity.~      An endoscopic treatment describes by Inoue  Anti-Reflux Mucosectomy  ( ARMS) allows to~     decrease the gastro- esophageal reflux disease.~      This treatment is an equivalent of on treatment of the line Z which would at the same time~     allow to make sure of the decrease of recurrence on the line Z by complete treatment of this~     one and to handle the reflux of these patients.~      In this experimental series, 10 patients having made this endoscopic treatment were able to~     stop their treatment by PPI.~      The purpose of this study will be to make sure of the efficiency of the endoscopic treatment~     of the reflux by it on treatment of this line Z while decreasing the frequent recurrences on~     this line Z.~   "
22057|NCT03278314|"~     To provide TEZ/IVA combination therapy to CF patients who are 12 years of age and older who~     completed Vertex TEZ/IVA combination therapy clinical studies (NCT02565914 or NCT03150719).~     To provide TEZ/IVA combination therapy to CF patients in critical need who are 12 years of~     age and older, homozygous for F508del.~   "
22058|NCT03278301|"~     To collect data on the routine patterns of use, safety and effectiveness, including the~     clinical and technical performance of the CorPath GRX System, in the delivery and~     manipulation of coronary guidewires and stent/balloon catheters, and manipulation of guide~     catheters during PCI procedures.~   "
22061|NCT03278262|"~     The study will assess the mean change in Visual Acuity (VA) (overall and stratified by~     baseline VA) at year 1 and 2 of treatment with Aflibercept in real-life setting.~      In addition, the study will ascertain the baseline VA in treatment -naïve wAMD patients who~     start treatment with Aflibercept in a real-life setting and it will assess the impact of~     baseline VA on the outcomes of Aflibercept treatment.~   "
22062|NCT03278249|"~     The purpose of this research study is to see if people can produce ketones in their blood~     with the modified Atkins diet. Modified Atkins diet is a diet that produces ketones in your~     blood by restricting carbohydrates to <20 grams per day. Ketones are substances that are~     produced in the blood when fat is being broken down. Ketones may help radiation work better~     and may starve your tumor because it is thought that some brain tumors can not use ketones to~     grow and can only use sugar or glucose to grow.~   "
22063|NCT03278236|"~     Obesity is a serious medical condition, the adverse consequences of which include increased~     risk of cardiovascular disease, diabetes mellitus, reduced fertility and cancer. The economic~     cost of obesity was placed at $58 billion dollars in Australia in 2008 [1]. Studies in mice~     and non-human primates have shown that moderate caloric restriction (CR) increases lifespan~     and reduces the incidence of cardiovascular disease, cancer, and type 2 diabetes [2]. Reduced~     risk of chronic diseases is also observed in humans following CR [3]. However, daily CR is~     difficult to maintain long term, since the body defends against weight loss by inducing~     metabolic adaptation[3] and altering the hormonal appetite response [4]. An emerging number~     of studies are examining the effects of limiting food intake to prescribed time periods per~     day, or every other day. Time restricted feeding (TRF) describes a dieting approach where~     food is available ad libitum, however only for a limited period of time (i.e. 3-12 hours).~      This pilot study will examine the effects of restricting daily food intake to within a 10~     hour period on glycaemic control, body weight and biomarkers of metabolic health for 6-weeks.~     This study will build on the existing knowledge base in humans as to whether meal timing,~     rather than caloric restriction per se, is important to provide the stimulus required to~     improve metabolic health and reduce risk of chronic disease.~   "
22064|NCT03278223|"~     The purpose of this study is to evaluate the clinical performance of the contact lens care~     product Oté Sensation in a representative population of soft contact lens wearers. For~     comparison, a widely used FDA approved soft lens multipurpose solution will be used as a~     control. This control product has been tested in previous clinical trials.~   "
22065|NCT03278210|"~     The main goal of this study is to evaluate the additional value of EEG-fMRI method in the~     presurgical evaluation of focal intractable epilepsy.~      To consider a patient for surgery, the main difficulty is to define accurately the~     epileptogenic zone. This definition is complex and is often supported by several types of~     exploration (MRI, FDG PET, neuropsychological testing, video-EEG...). In this study we will~     evaluate the adding value of the simultaneous recording of EEG and fMRI in the epileptogenic~     zone definition.~   "
22066|NCT03278197|"~     Patients diagnosed with localized prostate cancer may be eligible for different treatment~     options. MAASTRO Clinic (MAAStricht Radiation Oncology) developed a web-based decision aid~     tool for these patients. The goal of the tool is to help patients to understand the~     treatments, and empower the patients to participate in the decision making process. The aim~     of this study is threefold:~      (A) user-testing and validation of the tool, by using a systematically development process~     compliant with the IPDAS (International Patients Decision Aids Standards) criteria (B)~     establish the impact of the tool on the decision making process; (C) identify barriers and~     facilitators for the implementation of shared decision making and the tool in clinical~     practice.~      The study covers 3 phases:~        1. Development phase 1.1 Assess decisional needs of patients and clinicians. 1.2 Test~          patients' and clinicians' comprehensibility, acceptability and usability on the~          alpha-version of the tool. 1.3 Value clarification: Delphi study with former prostate~          cancer patients to determine the most important patient preferences and value~          clarification aspects the decision aid should include.~        2. Implementation phase: Develop an implementation and dissemination plan for shared~          decision-making which is based on the evaluation of barriers and facilitators for the~          use of patient decision aid tools in clinical practice.~        3. Evaluation phase: Establish the impact of on knowledge, decisional conflict and the~          shared decision-making process, as well as the extent to which clinicians involve~          patients in decision-making.~      A mixed method will be used. It comprises structured interviews combined with think aloud and~     questionnaires with stakeholders involved in the whole process of development, implementation~     and evaluation (patients, urologists, radiotherapists, nurses, general practitioners, patient~     organizations, and insurance companies).~   "
22067|NCT03278184|"~     The experience of pain derives from changes in brain excitability. Therefore, modulating the~     excitability of cortical areas involved in pain processing may become an attractive option in~     the context of multimodal analgesia during the postoperative period.~   "
22068|NCT03278171|"~     Post-traumatic stress disorder (PTSD) is a psychiatric pathology noticed in the DSM-5, in~     troubles due to a traumatism or a stress factor and appearing at least 1 month after~     confrontation with trauma. This trouble can become chronic, and be the source of psychiatric~     and somatic comorbidities, which themselves have personal, professional and economic~     consequences at the level of the individual and society.~      Some studies looked at the psychological effects induced by a stay in intensive care unit~     (ICU) since few years. The emergence of PTSD in these patients has been described, with an~     incidence varying from 4% to 60%.~      The literature is contradictory about identified risk factors for PTSD. It's not possible to~     design a screening of these patients actually, only focused on the risk factors. It has been~     shown that the presence of acute stress trouble (presence of symptoms during the first month~     after the traumatism) was a risk factor for PTSD. Early detection of acute stress disorder~     could be a way to screen risk of emergence of a post-intensive care PTSD. Post-intensive care~     consultations have been done at 6 months, but not systematically. Only few symptoms are~     looked for and a sizable part of this population were not being followed probably due to a~     non-diagnosed-PTSD. In case of the emergence of a post-intensive care PTSD, those patients~     will never be diagnosed and treated, favoring all complications linked to this trouble.~      Associated with other factors, IES-R (Impact Event Scale Revisited) at the ICU exit would~     permit an exhaustive screening of patients at risk for PTSD and could permit to propose them~     an adapted care and then limit the emergence of PTSD and its consequences..~      In this study, the investigators will screen acute stress symptoms within 8 days following~     the ICU's exit, using the IES-R, in order to evaluate his ability to predict the emergence of~     a PTSD at three months. IES-R is an auto-questionnaire, easy and fast with good psychometrics~     capacities for PTSD.~   "
22069|NCT03278158|"~     This is a single-dose dose escalation trial in a randomised, single-blind, placebo-controlled~     group-comparison design to investigate the safety and tolerability of XEN-D0501 in 24~     subjects with diabetes mellitus type 2 where life style changes and treatment with metformin~     has failed to effectively reduce blood glucose concentrations.~   "
22086|NCT03277937|"~     INTRODUCTION: Bleeding from gastric varices (GV) is associated with a high mortality rate.~     Injection of cyanoacrylate (CYA) using standard gastroscope has demonstrated to achieve~     higher hemostasis and lower rebleeding rates compared to band ligation or sclerotherapy.~     Nevertheless CYA treatment is known to be associated with significant adverse events.~     Pulmonary embolism due to CYA injection is a serious and sometimes fatal complication of this~     therapy. These patients usually have respiratory symptom, however this complication can be~     present in asymptomatic patients, being demonstrated only by a pathological CT scan. On the~     other hand, it has been described that the risk of glue embolism dependent on the volume of~     CYA injected, being significantly greater with high volumes. Other complications related to~     CYA injection are hemorrhage from injection site ulcers, fever, peritonitis, needle~     impaction, and even death. Also the injection material can cause serious damage to the~     endoscope.~      Currently, endoscopic injection of CYA can be performed by direct visualization using a~     standard gastroscope or guided by Endoscopic Ultrasound (EUS) with injection of CYA alone or~     in combination with coils. The injection of coils in conjunction with CYA may reduce or~     eliminate the risk of glue embolization as coils can function as a scaffold to retain CYA~     within the varix and may decrease the amount of glue injection needed to achieve~     obliteration. It has been previously demonstrated that treatment under EUS guidance may have~     some benefits. It allows a precise targeting of the varix lumen or afferent feeding veins,~     being the vessel obstructed with less amount of CYA than used for the blind injection by~     standard endoscopy, reducing the risk of glue embolism. EUS can confirm varix obliteration by~     Doppler effect and also the visualization of GV is not impaired by blood or food in the~     stomach, thus it can be used in the setting of active hemorrhage.~   "
22070|NCT03278145|"~     Acute leukaemias (AL) are the first cause of cancer in children, with a majority of B acute~     lymphoblastic leukemia (ALL). Some of the processes causing leukemogenesis are already~     identified and well characterized in some AL subtypes such as translocation t (12; 21) of~     good prognosis in ALL. However, translocations are not sufficient to explain all the~     different processes of leukemogenesis, and other processes such as genetic / epigenetic~     mutations leading to oncogene activation / inhibition of tumor suppressor genes are the~     object research. Among the latter, mutations in tumor suppressor genes such as DCC (Deleted~     in Colorectal Cancer) have recently been identified in solid cancers, such as in hemopathies.~     This gene was subsequently characterized as encoding a dependence receptor specifically~     binding to its Netrin-1 ligand.~      Dependence receptors (RDs) are transmembrane receptors that cause cell death in the absence~     of their ligand. RD decreases tumor progression and overexpression of their ligands is~     observed in many cancers, such as B lymphomatous hemopathies in adults. Inhibition of the~     RD-ligand interaction constitutes a new and original therapeutic target in oncology.~      The aim of this study is to investigate whether RDs, in particular DCC, are expressed in~     acute leukemia cells at the time of diagnosis or relapse in patients aged 1 to 18 years, and~     then in these patients at the time of the remission balance. This research will be both~     qualitative and quantitative.~   "
22071|NCT03278132|"~     The purpose of this study is to evaluate the immunogenicity and safety of EV71 vaccine in~     infants aged 6 to 35 months old, by detecting the dynamic changes of neutralizing antibody at~     different time after vaccination~   "
22072|NCT03278119|"~     Age-related sleep changes and common sleep disorders like obstructive sleep apnea (OSA) may~     increase amyloid burden and represent risk factors for cognitive decline in the elderly. We~     will directly interrogate the brain using a 2-night nocturnal polysomnography (NPSG) and~     amyloid deposition using C-PiB PET/MR both at baseline and at the 24-month follow-up. This~     study has the potential to identify the mechanisms by which age-related sleep changes~     contribute to AD neurodegeneration in cognitively normal elderly, the group that could profit~     the most from sleep preventive strategies.~   "
22073|NCT03278106|"~     This phase II trial studies how well trifluridine/tipiracil hydrochloride combination agent~     TAS-102 (TAS-102) works in treating participants with biliary tract cancers that have spread~     to other places in the body. Drugs used in the chemotherapy, such as trifluridine/tipiracil~     hydrochloride combination agent TAS-102, work in different ways to stop the growth of tumor~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading.~   "
22074|NCT03278093|"~     A cross-sectional study which will look at the effects of AFO's and vibrating insoles on~     balance performance in people with CMT disease.~   "
22075|NCT03278080|"~     The purpose of this study is to set an optimal measurement time for assessing driving ability~     in a driving simulator in healthy volunteers.~   "
22076|NCT03278067|"~     This pilot study, to be conducted in the 2017/2018 influenza season, is a safety surveillance~     study using passive surveillance enhanced with a reporting card system to report adverse~     events of interest (AEIs) after Flu vaccination.~   "
22077|NCT03278054|"~     Aim: To evaluate and compare the outcome of primary endodontic treatment following use of~     different instrumentation techniques.~      Materials and methods: Study subjects were recruited from the pool of patients referred for~     the non-surgical root canal treatment in the Department of Conservative Dentistry &~     Endodontics at PGIDS, Rohtak (Haryana).~      The study population comprised of patients requiring primary root canal treatment following~     the diagnosis of pulpal necrosis with chronic apical periodontitis in mature mandibular first~     and second molars.~      Subjects were allocated to one of the three study groups: manual instrumentation, ProTaper~     instrumentation and Hybrid instrumentation.~   "
22078|NCT03278041|"~     The aim of the study is to compare maxillary obturator versus submental artery flap after~     partial maxillectomy in the aspect of Quality of life outcomes.~   "
22079|NCT03278028|"~     The primary objective of this study is to evaluate the effectiveness of A-101 compared to~     Vehicle when applied to 1 Target common wart on the trunk or extremities twice a week.~   "
22080|NCT03278015|"~     Pancreatic cancer is one of the deadliest tumor types, there is no effective treatment method~     clinically. Recently radical surgical resection is recommended for this cancer, How to~     improve the survival rate of patients is the doctors' goals . Postoperative chemotherapy can~     partly raise post-operative survival rate. the purpose of this study is to three chemotherapy~     regimens(gemcitabine monotherapy, S-1 monotherapy and combining nab-paclitaxel with~     gemcitabine),which is best regimens for raising patients' survival rate, and will provide a~     chemotherapy choice for clinic therapy of pancreatic cancer.~   "
22081|NCT03278002|"~     This is a US multi-center, prospective, real world, observational drug registry enrolling~     patients actively treated with Uptravi. Participating patients will be followed prospectively~     for a maximum of 18 months from the date of enrollment into the registry.~   "
22082|NCT03277989|"~     Study Title INFINITY™Total Ankle Replacement Follow-up (ITAR) Study Design Prospective,~     multi-site, multi-year post-market clinical follow-up study Study Group Primary/Unilateral~     and/or bilateral Total Ankle Arthroplasty subjects implanted with INFINITY™ Total Ankle~     System Number of Subjects 200 with 10 sites~   "
22083|NCT03277976|"~     This is a prospective, multi-center, research study designed to evaluate the acute~     achievement of pulmonary vein (PV) isolation with ThermoCool SmartTouch (ST) and ThermoCool~     SmartTouch SF (STSF) catheter using the Ablation Index Module.~   "
22084|NCT03277963|"~     Obstructive sleep apnea syndrome (SAOS), very commonly associated with obesity, induces major~     disturbances in sleep architecture. The hypotheses in this work are twofold: on the one hand,~     the SAOS could generate pain perception disorders in a population already affected by the~     mechanical weight constraints, generating potentially painful complications, and on the other~     hand, the improvement of sleep provided by continuous positive airway pressure (PPC)~     ventilation could normalize the pain perception thresholds. It was shown an early rebound~     effect after treatment on increasing pain threshold in the healthy subject. We want to check~     it among obese patients with OSA in early and mid-term.~   "
22085|NCT03277950|"~     Individuals with stroke show abnormal movement pattern of upper limb. The movement pattern~     needs to be corrected. There are several methods to train normal movement. Exercise with~     technology is an active movement and affects sensory and cognitive systems. It may benefit to~     individuals with stroke in training.~   "
22087|NCT03277924|"~     Phase I-II, single-arm, non-randomized, open-label, multicenter, international clinical~     trial, with two cohorts (Soft Tissue Sarcoma and Bone Sarcoma). Seven sites in Spain and 3~     sites in Italy.~      Patients will receive sunitinib 37.5 mg/day (or recommended dose defined in phase I) orally~     continuously + nivolumab 3 mg/kg intravenous every 2 weeks infused over 1 hour. Treatment~     will continue until disease progression, development of unacceptable toxicity,~     non-compliance, withdrawal of consent by the patient or investigator decision.~      The main goal is to evaluate the efficacy of the sunitinib plus nivolumab combination as~     measured by the progression-free survival rate (PFSR) at 6 months in patients with advanced~     soft tissue and bone sarcomas.~   "
22088|NCT03277911|"~     Early diagnosis of thyroid and lipid disorders by regular screening, and treatment of such~     disorders in CKD patients may be highly beneficial to slow progression of CKD. The study will~     be conducted to investigate thyroid function and lipid profile in patients with chronic~     kidney disease.~   "
22089|NCT03277898|"~     In Canada, approximately 68 women are diagnosed with breast cancer every day.~     Chemotherapy-related cognitive changes (CRCC) are reported by up to 75% of breast cancer~     survivors during treatment and symptoms persist in 35% of survivors after treatment. Women~     report that CRCC negatively impacts their everyday functioning and substantially reduces~     their overall quality of life. Effective clinical interventions to manage CRCC are elusive.~     As a result, breast cancer survivors typically receive little to no advice on how to prevent~     or manage CRCC. Aerobic exercise is a type of physical activity that uses large muscle~     groups, is rhythmic in nature, and can be sustained for at least 10 minutes (e.g., walking,~     jogging, indoor cycling). It has been associated with improved quality of life in breast~     cancer survivors. It also holds great promise as an intervention to prevent or mitigate CRCC.~     However, there is limited evidence from experimental studies to confirm this. Therefore, the~     primary aim of this trial is to evaluate the impact of a supervised aerobic exercise~     intervention on CRCC in women diagnosed with early-stage breast cancer. Recruited women will~     be randomized into one of two groups: (1) aerobic exercise during chemotherapy, or (2) usual~     care during chemotherapy and the aerobic exercise post-chemotherapy (i.e., wait-list control~     group). This study will test several novel hypotheses, including whether exercise during~     chemotherapy can prevent and/or mitigate CRCC and its negative impact on quality of life~     among women with breast cancer, and whether the timing of the exercise intervention matters~     (i.e., exercise during versus after chemotherapy). The results of this study aim to address~     the concerns of women affected by CRCC who are currently lacking available evidence-based~     treatment options, as well as oncology care providers' need to have options to recommend to~     their patients to prevent or manage CRCC.~   "
22090|NCT03277885|"~     In France, the Direction of Research, Studies, Evaluation and Statistics, in their 2015~     report on Chronic pain: the state of health of the population in France - Indicators~     associated with the Public health , shows that 34.6% of the working population declare~     themselves to be facing psycho-social risks, including chronic pain disorders.~      The main survey conducted in France on chronic pain showed that 32% of French people~     expressed daily pain for more than 3 months, with 20% reporting chronic pain of moderate or~     severe intensity. According to a report by the HAS in 2009, about 30% of patients consulting~     for pain in pain center (CETD) are working and 20% are on sick leave or work-related~     accidents.~      Chronic pain would also be responsible in France for the limitation of professional~     activities in 6% of 25-64 year olds, 15% job losses, 12% changes in work responsibilities,~     12% changes in employment and 18 % of associated depressions. In addition, 40% of chronic~     pain patients experienced a direct impact at work: loss, change in responsibilities and~     activity.~      Combined with the difficulty of understanding and thus treating chronic pain, these data~     demonstrate the challenge faced by occupational health services in their preventive, curative~     and palliative approach to chronic pathologies. Innovation for any new prevention and therapy~     for chronic pain then becomes necessary.~      The main objective of this first study will be the evaluation of the prevalence of pain~     disorders among the employees of French furniture shop. .~   "
22091|NCT03277872|"~     Prospective, randomized and controlled who will be conducted in Maisonneuve-Rosemont hospital~     and whose objectives are:~        -  To observe if the alterations of the NoL index and the standard monitoring (Mean~          Arterial Blood Pressure and Heart Rate) (using the variability of NoL index and standard~          monitoring, peak NoL index and peak standard monitoring values, and number of time~          passed over their respective threshold for nociceptive response) are more accentuated~          after laryngoscopy using the classical MAC blade versus single-use disposable blade of~          the Glidescope.~        -  To observe the nociceptive response (using the variability of NoL index and standard~          monitoring, peak NoL index and peak standard monitoring values, and number of time~          passed over their respective threshold for nociceptive response) related to the~          insertion of endotracheal tube between vocal cords during the intubation.~      Study plans to enroll 50 adult patients scheduled to undergo either general, gynecological,~     neurological, orthopedic, plastic or urological surgery under general anesthesia and who~     necessitate endotracheal intubation.~   "
22092|NCT03277859|"~     The specific aims of the proposed study are to evaluate: 1) the feasibility of design~     elements of a Strength and Awareness in Action: an Intervention for Post-Acute TBI Headaches~     (SAA-TBI) intervention trial (e.g., an exercise run-in to facilitate participant retention);~     2) yoga instructor fidelity; and 3) variability estimates for candidate proximal and distal~     outcomes. Performance of validated measures, including those associated with quality of life,~     as well as data collected via ecological momentary assessment and pedometry (physical~     activity) will be evaluated.~   "
22093|NCT03277846|"~     The purpose of this research study is to determine whether Nexalin Trans-cranial Electrical~     Stimulation (TES) is an effective treatment for depression among patients who are candidates~     for ECT. A secondary aim to assess whether Nexalin can be used as an alternative to ECT.~     Although Nexalin has been approved for use in the US, using Nexalin to treat depression in~     this way is investigational and experimental. If Nexalin is found to be an alternative to~     ECT, it could offer a safer treatment for depression with less side-effects and a lower cost.~   "
22094|NCT03277833|"~     The investigators performed a 8-week, randomized, double-blind, placebo-controlled human~     trial to evaluate the efficacy and safety of Gynostemma Pentaphyllum(Dungkulcha) on~     alleviation of chronic stress-induced strain. The investigators measured decrement of body~     fat parameters, State&Trait version of STAI, Beck Anxiety Inventory(BAI), Hamilton Anxiety~     Inventory(HAM-A), and monitored their blood pressure.~   "
22095|NCT03277820|"~     The aim of this study is to investigate whether the microbiota in the upper respiratory tract~     (nasopharynx, adenoids and middle ear fluid) of otitis media with effusion (OME) patients is~     changed after 4 weeks of probiotic product intake. Therefore, bacterial DNA from swabs, fluid~     and tissue will be isolated via commercially available DNA extraction kits, followed by~     Illumina MiSeq sequencing in order to identify the bacterial species present in these~     samples. Furthermore, the concentration of specific pathogens will be monitored via qPCR.~   "
22096|NCT03277807|"~     This prospective observational study assesses whether women who regularly exercise during~     pregnancy show reduced low grade Inflammation, compared to women who are not regularly~     exercising. Furthermore, the effects of regular physical activity in pregnancy on fetal and~     neonatal outcomes will be investigated. 3 groups of pregnant women will be formed (group 1:~     regularly physically active women; group 2: physically inactive women and group 3: women with~     a history of preeclampsia or positive history of metabolic conditions increasing the risk of~     hypertensive disorders in pregnancy).~   "
22097|NCT03277794|"~     This project builds upon initial proof of concept work examining the optimal set of supports~     for youth who have recently exited homelessness - an intervention comprised of mental health~     and peer supports alongside transitional case management. This collaborative model will be~     tested as a proof-of-concept in Thunder Bay with Indigenous youth and a trial will be~     conducted in Toronto to optimize and determine the effectiveness of the existing model of~     support.~   "
22098|NCT03277781|"~     An abdominal aortic aneurysm (AAA) is a swelling of the main blood vessel (aorta) in the~     abdomen. If the swelling gets too large the aorta can burst and this is usually fatal. In~     order to prevent rupture, AAA can be surgically repaired. This is usually carried out when~     the size of the AAA is more than 5.5cm in diameter as below this size, the risk of rupture is~     lower than the risk of surgery. AAA are usually asymptomatic before rupture but can easily~     and safely be diagnosed by ultrasound scanning. There is currently a national screening~     programme for men, but not women.~      Women are not screened for AAA on the basis that the disease is less common in females.~     However, 33.6% of all deaths caused by ruptured AAA in England and Wales are in females (1109~     female deaths)1. Death rates due to ruptured AAA in men have nearly halved over the last~     decade but the reduction in female deaths over the same time period is less than one third.~     Females with AAA are also 4-times more likely to rupture their aneurysm and have higher rates~     of complications and death after emergency surgery than men.~      There are groups of females such as smokers, who are at high risk of AAA. The investigators~     have identified risk factors that are easily identifiable from general practice databases~     that may be able to identify women at high risk of AAA. In this research it will be~     determined whether it is feasible to select women for AAA screening using these risk factors,~     how many women in these high-risk groups attend if they are invited for AAA screening, and~     screen women to determine the numbers in the different risk groups who have AAA. This will~     allow the assessment of whether screening women for AAA could be clinically or cost effective~     and who would benefit the most. The investigators will also investigate if the siblings of~     patients with AAAs are at higher risk of disease by inviting them for screening too.~   "
22099|NCT03277768|"~     The proposed research evaluates tissue oxygenation (StO2) as measured by resonance raman~     spectroscopy (RRS) in premature infants with and without patent ductus arteriosus (PDA). This~     is a prospective observational study of infants born at < 30 weeks of gestation. The primary~     aim of this study is to determine if the difference in pre- and post-ductal StO2 as detected~     by RRS is more significant in premature infants with PDA in comparison to infants without~     PDA. The secondary aim of this study is to determine if the difference in pre- and~     post-ductal StO2 as detected by RRS is more significant in infant who develop serious adverse~     events.~   "
22100|NCT03277755|"~     The purpose of this study is to evaluate the pharmacokinetics (PK) of AL-335, odalasvir (ODV)~     and its metabolites ALS-022399 and ALS-022227, after a single oral dose of ODV and AL-335~     respectively, in participants with moderately impaired hepatic function compared to~     participants with normal hepatic function. Also to evaluate the steady-state PK of AL-335 and~     its metabolites ALS-022399 and ALS-022227, ODV and simeprevir (SMV) after multiple oral doses~     of the combination of AL-335+ODV+SMV, in participants with moderately impaired hepatic~     function compared to participants with normal hepatic function.~   "
22101|NCT03277742|"~     The objective of this study is to evaluate an integral strategy in which diabetes mellitus 2~     (DM2) and pulmonary tuberculosis (TB) are managed together. The researchers propose a~     community intervention with two arms in 4 health centers in Orizaba, Veracruz. Patients will~     be assigned to either arm by convenience. One arm will receive the joint treatment strategy~     and another the routine treatment used in health services.~   "
22102|NCT03277729|"~     The purpose of this research is to find the best dose of genetically modified T-cells, to~     study the safety of this treatment, and to see how well it works in treating patients with B~     cell non-Hodgkin lymphoma that has come back or did not respond to previous treatment.~   "
22103|NCT03277716|"~     The purpose of this study was to prospectively evaluate the efficacy and safety of TACE~     combined with MWA in patients with huge unresectable hepatocellular carcinoma.~   "
22104|NCT03277703|"~     This proposed study will assess the immunogenicity, safety, and clinical efficacy of an~     influenza vaccine booster dose strategy in patients with autoimmune diseases who are~     receiving immunosuppressive therapies. Investigators will compare serologic responses to~     single versus a booster dose of influenza vaccine in patients with inflammatory bowel disease~     (IBD- Crohn's Disease or Ulcerative Colitis) or rheumatologic diseases who are receiving~     immunosuppressive therapies. Subjects will be randomized to receive either one or two doses~     of influenza vaccination in year #1. In year# 2, all participants will be given two doses of~     influenza vaccine. Serologic responses will be measured pre and 4-6 weeks post vaccination.~     This study will also assess the immunogenicity and safety of a booster vaccine strategy in~     the prevention of influenza-like illness (ILI). Investigators anticipate that booster dose~     strategy will improve both clinical and serologic responses in this vulnerable population.~   "
22105|NCT03277690|"~     This is a double-blind, randomized, placebo-controlled withdrawal and rescue/restoration~     study in subjects with endogenous CS previously treated with single-arm, open-label~     levoketoconazole that will assess efficacy, safety, tolerability, and pharmacokinetics of~     levoketoconazole.~   "
22115|NCT03277560|"~     Major Trauma Outcome Measures Study (MaTOMS): A feasibility Study into using outcome measures~     in major trauma patients.~      At present patients who suffer major trauma (multiple, serious injuries that could result in~     death or serious disability e.g. serious head injuries and multiple fractures), are now able~     to survive due to advances in modern medicine. Unfortunately they may be left with long term~     disabilities such as problems with performing day to day activities. We currently do not know~     how bad these disabilities are or have any way of judging any differences between the~     outcomes of different hospitals.~      MaTOMS is a feasibility study taking place in one hospital, the John Radcliffe Hospital which~     aims to help answer these questions by developing a set of structured interviews that can be~     used after an injury to find out about patient outcomes. It will identify how difficult or~     easy it is to collect the data and information outlined in this project, and whether the~     types of data and information collected as part of the interviews are a good indicator of a~     patient's outcomes.~      Over 30 months the study will recruit up to 100 patients who are aged 2 years and over who~     have been admitted following major trauma. Major trauma will be defined as a score of 9 or~     more on the Injury Severity Score, a widely used system to stratify those who suffer an~     injury.~      Those who agree to take part following a consent process will undergo structured interviews~     both in hospital and twice via telephone in the year following discharge. Some participants~     will take part in an additional interview either asking about their experience of answering~     the questions during the structured interview or exploring their experience and feelings~     about their traumatic injury to see if our structured interviews are missing any aspect of~     their experience.~      The main objectives for this feasibility study is to test the feasibility of routine~     collection of outcome measurement data following major trauma.~   "
22106|NCT03277677|"~     The high chloride content of 0.9%sodium chloride (0.9%NaCl) leads to adverse~     pathophysiological effects in both animals and healthy human volunteers. Small randomized~     trials confirm that the hyperchloremic acidosis induced by 0.9%NaCl also occurs in patients.~     A strong signal is emerging from recent large propensity-matched and cohort studies for the~     adverse effects that 0.9% NaCl has on the clinical outcome in surgical and critically ill~     patients when compared with balanced crystalloids. Major complications are the increased~     incidences of acute kidney injury and the need for renal replacement therapy, and that~     pathological hyperchloremia may increase postoperative mortality.~      Fluid resuscitation with 0.9% NaCl in animals with sepsis resulted in hyperchloremic~     metabolic acidosis, worsened AKI, and increased mortality when compared with resuscitation~     with a balanced crystalloid solution.~      Furthermore, hyperchloremic acidosis also resulted in increased concentrations of circulating~     inflammatory mediators in an experimental model of severe sepsis in rats, with a~     dose-dependent increase in circulating interleukin-6, tumor necrosis factor-a, and~     interleukin-10 concentrations with increasing acidosis.~      Thus, in this study, investigators compared the effects of a balanced crystalloid solution~     with 0.9% NaCl on the renal function in severe sepsis/septic shock patients. Investigators~     hypothesized that balanced crystalloid solution resuscitation would decrease AKI incidence~     and severity and would improve immunomodulatory effect when compared with 0.9% NaCl~     resuscitation.~   "
22107|NCT03277664|"~     The Study of Asthma Adherence study was a multicentre, single-blind, parallel group~     randomised controlled trial, with an allocation ratio of 1:1. Outpatient or inpatient with~     doctor-diagnosed asthma aged 6 months-3 years attending Shanghai Children's Medical Center~     and 14 Community hospitals were screened for eligibility. Before randomization, all~     participants had the same chips attached to their regular nebulizers. Caregivers were told~     the devices monitored the date and time of all actuations. All caregivers were asked to fill~     the questionnaire about the patients. After randomisation, all caregivers had their nebulizer~     technique checked by a qualified asthma nurse, and received a brief asthma education session,~     emphasising the importance of taking inhaled steroids regularly.~   "
22108|NCT03277651|"~     This study is to establish a noninvasive diagnostic platform based on hemodynamic information~     for the assessment of liver fibrosis, liver cirrhosis and portal hypertension.~   "
22109|NCT03277638|"~     The purpose of this study is to test the side effects and efficacy of using Laser~     Interstitial Thermotherapy (LITT) combined with Pembrolizumab. LITT is a minimally invasive~     surgical technique that uses a laser to heat brain tumors.~      Pembrolizumab is an investigational (experimental) drug that works by helping participants'~     immune system work correctly to detect and fight cancer cells. Pembrolizumab is experimental~     because it is not approved by the Food and Drug Administration (FDA), for this use, though it~     is approved to treat other cancers.~   "
22110|NCT03277625|"~     This observational study aims to prove the safety and efficacy of a modified method of~     reconstruction after pancreatic head resection utilizing a single Omega shaped intestinal~     Loop with an additional anastomosis between the pancreatic and biliary anstomoses. This~     simple and fast method is expected to provide the advantages of a double-loop reconstruction~     without adding time and difficulty to the reconstruction process during~     pancreaticoduodenectomy. The additional intestinal anastomosis should allow Diversion of~     pancreatic Juice from bile thus reducing the severity of possible postoperative pancreatic~     Fistula, especially in the subgroup of patients undergoing a pancreaticoduodenectomy and~     having a high-risk pancreatic remnant, i.e. very soft, fragile and fatty pancreas with a~     tiny, non-dilated pancreatic main duct. The Primary Point of the study ist the severity of~     postoperative pancreatic Fistula, as well as the total rate of severe postoperative~     complications, defined as Grade 3b or more according to the classification of Dindo-Clavien.~   "
22111|NCT03277612|"~     The study will help investigators learn more about whether different delivery modes influence~     infant's brain development~   "
22112|NCT03277599|"~     Analgesia following tympanomastoid surgery is critical for the prevention of postoperative .~     There are very few regional anesthesia methods used to achieve this goal.~   "
22113|NCT03277586|"~     Preclinical and clinical studies have shown that consuming probiotics can improve mood,~     anxiety, and cognition, as well as alter brain activity in both rodents and healthy humans.~     Data from our recent open-label, 8-week pilot study provided the first evidence of these~     effects in depressed patients, with significant improvements observed in overall mood,~     anhedonia, and sleep quality. To further support this evidence and expand upon the search for~     biomarkers in depression, data from this pilot study is being used to plan a 16-week,~     double-blind randomized placebo-controlled trial to assess the effects of probiotics on~     depression. Participants diagnosed with depression recruited from the greater Kingston area~     will orally consume a probiotic supplement containing Lactobacillus helveticus and~     Bifidobacterium longum (Probio'Stick, Lallemand Health Solutions) or placebo once daily.~     Participants will undergo clinical assessments measuring mood, anxiety, cognition, and sleep~     using a battery of validated clinical scales to assess efficacy of the probiotic alleviating~     depressive symptoms; sleep will also be assessed objectively with an ambulatory~     polysomnogram. Neuroimaging data will be collected using magnetic resonance imaging and~     electroencephalography to look at functional, structural, and electrical changes in the brain~     associated with consumption of the probiotic. Molecular data will be collected from blood,~     stool, and urine samples to look at levels of cytokines and serotonin, and explore potential~     genes and proteins that may predict outcomes in depression. An informatics-based approach~     will be used to integrate clinical, neuroimaging, and molecular data to look for biomarkers~     that indicate disease state and predict antidepressant-like response to the probiotic.~     Results: We expect results to replicate and expand on our pilot data, demonstrating that~     probiotics are effective in alleviating symptoms of depression, and to find biomarkers that~     will predict these outcomes. The findings from this study will contribute robust scientific~     data that is currently lacking in this emerging field.~   "
22114|NCT03277573|"~     The purpose of the study is to test the safety and tolerability of twice daily Salsalate in~     patients with mild to moderate Alzheimer's Disease. Half of the participants will receive~     Salsalate and half will receive placebo during the 1-year duration of the study.~   "
22116|NCT03277547|"~     This is a prospective clinical cohort study that involves a baseline study visit followed by~     up to 3 annual follow-up study visits for a total follow-up of 36-48 months to evaluate the~     age- and sex-adjusted rate of change in kidney function, and to identify biomarkers of~     endothelial function, metabolomic profiles and clinical characteristics for the worsening of~     kidney function and for a rapid decline in kidney function.~      Funding Source - FDA OOPD~   "
22117|NCT03277534|"~     This study investigated whether electrical stimulation (ES) prior to a hand function training~     session for a total of eight weeks can better improve neuromuscular control and hand function~     in subacute stroke individuals and change electroencephalography-electromyography (EEG-EMG)~     coherence, as compared to the control (sham ES).~   "
22118|NCT03277521|"~     A repetitive, non-invasive brain stimulation technique referred to as theta burst stimulation~     can modulate corticomotor excitability and therefore has great rehabilitative potential for~     individuals with neurologic deficits, including individuals with spinal cord injury (SCI). In~     particular, intermittent theta burst stimulation (iTBS) can increase corticomotor~     excitability and may be a useful adjunct to physical rehabilitation to promote motor~     re-education after upper limb reconstruction in individuals with tetraplegia. Upper limb~     reconstruction involves surgical transfer of a non-paralyzed tendon or nerve with a redundant~     or less important function to perform a more critical function. Upper limb reconstruction is~     intended to help individuals achieve their goals related to activities of daily living and~     independence in the community. Outcomes after reconstruction are variable and depend largely~     on the efficacy of motor re-education of the transferred muscle to perform a new function.~     The long-term goal of our research is to determine whether iTBS combined with physical~     rehabilitation can improve motor re-education after reconstruction. As a first step, the~     purpose of this proposal is to determine the effect of iTBS on corticomotor excitability of~     proximal muscles in nonimpaired individuals and two groups of individuals with tetraplegia:~     individuals with and without upper limb reconstruction.~   "
22119|NCT03277508|"~     This research aims to integrate and develop a novel Brain-Computer Interface (BCI) controlled~     soft robotic glove, evaluate the ability of the glove in achieving common hand grasping~     postures and to assess the efficacy of the glove in assisting stroke patients with completing~     functional tasks. The BCI-controlled soft robotic glove utilizes patients' user intent to~     deliver specific electroencephalographic patterns that can trigger robot-assisted hand~     movement to the affected hand.~   "
22120|NCT03277495|"~     The primary goal of this study is to examine whether cigarette smokers can reduce their use~     of conventional, combustible cigarettes by switching to a Standardized Research E-Cigarette~     (SREC); whether participants can maintain these reductions and use of SRECs over a 12-week~     period; and whether there are changes in subjective and objective measures of health, appeal~     and acceptability of the products used during this time frame.~   "
22121|NCT03277482|"~     This research study is evaluating the safety and effectiveness of 2 immunotherapy drugs in~     combination with radiation therapy as a possible treatment for recurrent or metastatic~     gynecologic cancer.~      The names of the immunotherapy drugs involved in this study are:~        -  Durvalumab~        -  Tremelimumab~   "
22122|NCT03277469|"~     The aim of this study is to develop new tools using magnetic resonance imaging (MRI) that~     will improve the brachytherapy procedure and treatment for participants with gynecologic~     cancer.~   "
22123|NCT03277456|"~     This is a first in human, phase I, open label study of the MVA viral vector (produced in the~     novel immortalised duck retinal cell line AGE1.CR.pIX) expressing the influenza antigens NP~     and M1 as a fusion protein, in healthy adult volunteers. MVA-NP+M1 will be given alone~     intramuscularly as a single dose.~      There will be 1 study group and a total of 6 volunteers will be enrolled. Staggered~     enrollment will apply for the first three volunteers within the group.~   "
22124|NCT03277443|"~     In patient with skeletal open bite, Dose computer-aided surgery enhances the clinical~     outcomes and accuracy versus conventional model surgery~   "
22125|NCT03277430|"~     Uterus transplantation (UTx) is the only causative treatment for congenital or acquired~     uterus absence. Individual cases of UTx from a live donor (LD UTx) with healthy child birth~     performed so far showed favourable outcomes. The present study will include both LD UTx and~     UTx from deceased donors after brain death (DBD UTx). The aim is treatment of uterine~     infertility by UTx. It is is an ethically justifiable life-promoting transplantation. Twenty~     UTx will be performed in 2 parallel arms: 10 LD UTx and 10 DBD UTx. Immunosuppression will be~     administered. Phases of the UTx procedure are: in vitro fertilization - cryopreservation of~     embryos - uterus retrieval - UTx - follow up - embryo transfer - pregnancy - child birth -~     later graft hysterectomy - life long follow up. Introduction of UTx into clinical practice~     may enable women with uterine infertility to have their own children.~   "
22126|NCT03277417|"~     To evaluate and compare fetal cardiac performance by fetal echocardiography and delivery~     outcome between fetuses with isolated oligohydramnios, normal amniotic fluid and~     polyhydramnios.~   "
22127|NCT03277404|"~     This study evaluated the effect of removal of smear layer on the success of primary root~     canal treatment.Patients requiring primary root canal treatment in mature mandibular first~     and second molars were allocated to either smear layer positive group and smear layer~     negative group.~   "
22128|NCT03277391|"~     The objective of the study is to compare the efficacy of the Serratus Anterior Plane block~     (SPB) realised in its deep plane, with a multi-holed catheter in place for twenty four hours,~     to a standard intravenous analgesia for small videoassisted thoracic surgery interventions.~     The objective is also to evaluate the resorption rate of local anesthetic at this level, and~     make a population pharmacokinetic analysis.~   "
22129|NCT03277378|"~     This is a randomized, controlled, single blind, multi-center clinical investigation comparing~     success rates for anatomically placed leads to conventional, targeted lead placement for~     BurstDR™ during the trial evaluation period with the St Jude Medical™ Invisible Trial System.~     Subjects will be blinded to treatment group and randomized in a 1:1 ratio as follows:~      Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial~     trial evaluation period Group 2 (TB): targeted lead placement followed by BurstDR™~     stimulation during an initial trial evaluation period~      If the subject qualifies for permanent system implant according to pre-defined criteria after~     the initial trial evaluation period, the subject will exit the clinical investigation and~     continue their treatment per the physician's standard of care. Subjects who do not qualify~     for permanent system implant according to pre-defined criteria after the initial trial~     evaluation period may participate in an extended trial evaluation period, per physician~     discretion, during which they will be programmed with tonic stimulation. Subjects continuing~     to an extended trial evaluation period will be followed through the completion of the~     extended trial period. At the end of the extended trial evaluation period, subjects will exit~     the clinical investigation.~   "
22343|NCT03274570|"~     The aims of the research are:~        -  To predict factors affecting hand dysfunction in patient with rheumatoid arthritis~        -  To study the effect of hand dysfunction on quality of life in patient with rheumatoid~          arthritis~   "
22130|NCT03277365|"~     Many conditions affecting health are caused by a combination of environment, behaviors, and~     genes. While individuals can alter some factors in their lives to reduce the chances of~     developing different diseases (e.g., not smoking cigarettes), the contribution from genetic~     risk encoded by DNA remains with people throughout their lives. Scientists are still trying~     to determine the entirety of genetic factors that influence disease, but for some conditions~     it has been shown that the factors identified thus far can begin to identify people at high~     to low genetic risk. Looking across the genome, scientists can calculate a cumulative genetic~     risk score - which can be used to rank genetic risk compared to other worldwide populations.~      The goal of this study is to determine how genetic risk influences health decisions and other~     things that can be controlled in life. The first genetic risk score is calculated for~     coronary heart disease (CAD). CAD ultimately leads to heart attacks, heart failure and~     sometimes sudden cardiac death and is the main reason heart disease remains as the number one~     cause of death worldwide. Other researchers have shown that this genetic risk score can be~     used to identify people with low, intermediate, and high risk for coronary heart disease. It~     has also been shown that the use of statins (cholesterol lowering drugs) provides greater~     benefit and protection against heart attack for people with high genetic risk for coronary~     artery disease.~      Leveraging the Apple ResearchKit and the ResearchKit linked 23andMe API, customers of 23andMe~     are able to provide researchers access to their genomic data. Participants will use the~     ResearchKit app to provide consent, view study information, answer surveys, and contact the~     study team.~      Participants will be asked to complete 3 surveys. One before viewing genetic risk scores, one~     immediately after viewing scores, and one 6 months after viewing scores.~   "
22131|NCT03277352|"~     The purpose of this study is to determine the safety, tolerability, and efficacy of~     INCAGN01876 when given in combination with immune therapies.~   "
22132|NCT03277339|"~     Multicenter study comparing paroxetine (n=30) versus thermal cure (n=30) in patients with a~     diagnosis of Generalised Anxiety Disorders~   "
22133|NCT03277326|"~     To compare ISB vs anterior and posterior approaches of suprascapular block in terms of lung~     function and analgesia~   "
22134|NCT03277313|"~     The purpose of the study is to acquire additional data on efficacy, safety, tolerability,~     immunogenicity, pharmacokinetic (PK) and other parameters of HYQVIA in pediatric (age ≥ 2 to~     <16 years) participants with primary immunodeficiency disease (PIDD).~   "
22135|NCT03277300|"~     Supplementation of insufficient enteral nutrition with parenteral nutrition may optimize~     nutritional support and avert negative energy balance in critically ill patients, thereby~     improving outcome.~   "
22136|NCT03277287|"~     This is a prospective comparative study on 120 patients divided to three groups. Group A: 40~     patients laser will be applied 3 weeks post-surgical. Group B: 40 patients laser will be~     applied 3 months post surgical. Group C: 40 patients as a control not treated with laser from~     2017 to 2020 which will be conducted on patients with post-surgical cleft lip repair scaring.~      All patients will have 5-7 sessions with 4 weeks interval.~      Photographic documentation and evaluation of the scar will occur every 4 weeks.~   "
22137|NCT03277274|"~     The purpose of this study is to evaluate the effect of varying degrees of hepatic function on~     the single dose PK of IV TAK-954.~   "
22138|NCT03277261|"~     This is a Phase 3, randomized, multi-center, double-blinded, active-controlled study that is~     primarily designed to assess the Annualized Relapse Rate (ARR) and safety/tolerability of~     ublituximab/oral placebo (TG-1101; UTX) as compared to teriflunomide/IV placebo in subjects~     with Relapsing MS.~   "
22139|NCT03277248|"~     This is a phase 3, randomized, multi-center, double-blinded, active-controlled study that is~     primarily designed to assess the Annualized Relapse Rate (ARR) and safety/tolerability of~     ublituximab/oral placebo (TG-1101; UTX) as compared to teriflunomide/ IV placebo in subjects~     with relapsing MS.~   "
22140|NCT03277235|"~     The aims of this three-year study are to explore the protective and risk factors of~     resilience in colorectal cancer patients, and examine the effect of the resilience~     model-based care plan in reducing fear of recurrence and GI symptom distress and improving~     quality of life in newly diagnosed colorectal cancer (CRC) patients.~   "
22141|NCT03277222|"~     This study aims to see whether intranasal insulin is an effective treatment for problems with~     memory, concentration, slowed thinking, or any other cognitive function in people living with~     HIV/AIDS. This group of signs and symptoms are called 'HIV-associated neurocognitive~     disorders' or HAND. HAND can affect people living with HIV/AIDS even when they receive potent~     anti-HIV treatments. Treatment of HAND by specific medication or other means is not yet~     available. Intranasal insulin treatment has virtually no side-effects, and has already been~     tested in people with Alzheimer's disease, where it showed beneficial effects on memory, mood~     and quality of life~   "
22142|NCT03277209|"~     A dose escalation trial to assess the safety of plerixafor in patients with advanced~     pancreatic, high grade serous ovarian and colorectal cancer. To identify the proof of~     mechanism, by demonstrating alterations in T-cell tumour distribution, ideally associated~     with loss of tumour cells, measured by immunostaining, and changes in FDG uptake.~   "
22143|NCT03277196|"~     This is a Phase 3, 2-arm, multicenter study with an open-label ivacaftor arm and an~     observational arm to evaluate the safety and efficacy of long-term ivacaftor treatment in~     subjects with cystic fibrosis (CF) who are <24 months of age at treatment initiation and have~     an approved Ivacaftor-Responsive mutation~   "
22144|NCT03277183|"~     Although several large well designed clinical trials have shown that erythropoietin which is~     commonly used to treat anemia associated with kidney disease, increases the risk of stroke~     and heart disease, the mechanism for this increased risk is unknown. The investigators'~     preliminary studies show that the adverse effects of erythropoietin are from activation of~     the heterodimeric erythropoietin/ beta common receptor which only occurs with high doses of~     erythropoietin. The investigators propose a clinical trial of 120 patients assigned to low~     doses of erythropoietin given more frequently or the same cumulative dose of erythropoietin~     administered as a high dose once every two weeks and assess effects on the beta common~     receptor activation, inflammation and vascular disease as evidence by MRI of the carotid~     arteries.~   "
22157|NCT03277014|"~     Nutrition support is critical to a vast number of patients who are hospitalized annually~     because of critical illnesses or surgery. It is also necessary for patients with chronic~     intestinal failure (CIF), who often require parenteral nutrition over periods of weeks or~     months. While scoring systems that assess nutritional risks in patients exist, there are no~     guidelines for continuous nutritional monitoring during supplementation and parenteral~     feeding. Previous studies have hinted that insulin-like growth factor-1 (IGF-1) may serve as~     a biomarker for nutritional support efficiency; however, such studies were not statistically~     definitive. Therefore, the investigators aimed to assess IGF-1 as a biomarker for both~     diagnosing nutritional risk and malnutrition and for monitoring the efficiency of nutritional~     support, particularly compared to other biomarkers such as BMI as well as albumin,~     prealbumin, transferrin, and retinol-binding protein.~   "
22145|NCT03277170|"~     Objective: To determine the extent to which high-dose (30mg) oral montelukast, added to~     standard treatment in children with moderate and severe acute exacerbations improves~     outcomes.~      Central Hypothesis: High-dose oral montelukast, added to standard treatment in children aged~     5 to 17 years with moderate and severe acute asthma exacerbations, rapidly improves lung~     function, clinical severity, hospitalization rate and 72-hour symptom burden.~      Secondary Hypotheses:~        1. There are greater effects of high-dose oral montelukast on lung function and on the~          secondary outcomes in the presence of respiratory viral detection or~          leukotriene-mediated inflammation; and~        2. There is an interaction between viral detection and urinary leukotriene 4 level with~          treatment-response.~      Design: A two-arm, parallel randomized controlled trial of high-dose oral montelukast versus~     identical placebo, as add-on to standard treatment of systemic corticosteroid (SCS) and~     inhaled short-acting Beta-2-agonist (SABA), in children aged 5 to 17 years with moderate and~     severe acute asthma exacerbations.~      Intervention: High-dose oral montelukast added to standard treatment as one~     treatment-allocation arm, in comparison with standard treatment as the 2nd~     treatment-allocation arm.~      Primary and Important Secondary Endpoints: For the Primary Aim, the primary outcome measure~     to be compared between arms will be change of %-predicted airway resistance by impulse~     oscillometry (IOS) at 5Hz (%R5) at 2 hours after treatment initiation. Secondary outcomes~     will include improvement of %-predicted FEV1 (%FEV1), clinical severity measured using the~     validated Acute Asthma Intensity Research Score (AAIRS), hospitalization rate, and 72 hour~     symptom burden using the Pediatric Asthma Caregiver Diary (PACD). For the Secondary Aim, the~     investigators will determine (1) The effects of high-dose oral montelukast on lung function~     and on our secondary outcomes in the presence of nasal viruses and of greater~     leukotriene-mediated inflammation; and (2) The degree of interaction between viral detection~     and urinary leukotriene E4 (LTE4) level with treatment-response.~      Laboratory evaluations: The primary outcome (change of %R5) and select secondary outcomes~     (%FEV1, AAIRS, LTE4) will be measured before and again at 2 hours after treatment initiation.~     The other secondary outcomes will be measured at the time of hospitalization decision-making~     by the clinical team (hospitalization rate) or at 72-hours after treatment initiation (PACD).~   "
22146|NCT03277157|"~     The aim of this study is to determine the effect of daily consumption of Bifidobacterium~     animalis ssp lactis B94 (B. lactis B94) on stool frequency, gastrointestinal (GI) transit~     time, and gastrointestinal symptoms in adults with Prader-Willi syndrome. Participants (18-75~     years old, n=36) will be recruited and enrolled in a 20-week randomized, placebo-controlled,~     crossover study. Study participants will be randomized to B. lactis B94 or placebo each for a~     4-week period, preceded by a 4-week baseline and followed by 4-week washouts. Participants~     will complete daily questionnaires about stool frequency and stool form (transit). Dietary~     intake will also be assessed. A total of 5 stools (one in each period) will be collected for~     exploratory microbiota analysis. It is hypothesized that the B. lactis B94 will increase~     stool frequency, decrease the percentage of slow transit stools, and improve GI symptoms~   "
22147|NCT03277144|"~     The goal of this trial is to demonstrate that the use of Tri-Staple Technology for duodenal~     resection during open gastrectomy for cancer is safer than the use of other conventional~     methods of resection/closure of the duodenum and that the incidence of duodenal fistula can~     be decreased to that observed after the use of this technology in Laparoscopic and robotic~     gastrectomy, therefore almost three times lower than that currently reported in literature.~      Participating centres must have an annual volume of at least 20 gastrectomies per year.~   "
22148|NCT03277131|"~     The aim of the study is to evaluate the performance of DURAFIBER Ag and to assess how many~     bacteria are present in infected wounds over an 8 week period.~   "
22149|NCT03277118|"~     Wireless wearable devices (WWD) have been shown to be an effective means to measure patient~     activity and sleep-wake cycles in the ICU. However, no current studies involving WWD have~     demonstrated the ability of these devices to measure adverse outcomes, including delirium in~     critically ill patients. This study is unique because the investigators will implement~     monitoring with the WWD prior to extubation in the ICU to correctly measure first~     mobilization, as well as capture quality of sleep and episodes of delirium for the first five~     postoperative days.~   "
22150|NCT03277105|"~     The purpose of this study is to show that subcutaneous (SC) administration of daratumumab~     co-formulated with recombinant human hyaluronidase PH20 (Dara SC) is non-inferior to~     intravenous (IV) administration of daratumumab (Dara IV) in terms of the overall response~     rate (ORR) and maximum trough concentration (Ctrough).~   "
22151|NCT03277092|"~     Reaching a peripheral venous access or making a blood sample in a scared infant or toddler~     can be challenging even for experienced nurses o pediatricians. Up to 60% of children report~     pain and distress during venipuncture and multiple attempts can result in more difficult~     physical and emotional conditions for subsequent insertions so that the procedure should be~     performed with the less number of punctures as possible. In about one third of children, more~     than one attempt is required to achieve peripheral intravenous cannulation. In the last~     years, specific tools have been developed to enhance the success in venipuncture or~     incannulation. Near-infrared (NIR) technology consists on light-emitting diodes placed~     underneath the hand, that makes vessels visible by projecting the processed image in a green~     light directly on to the puncture site. According to previous studies, NIR had shown a trend~     in reduction of time employed for a blood sample, in children younger of 6 yr.~      The aim of this trial is to investigate if the use of the VeinViewer® in a pediatric blood~     drawing center could decrease time spent to perform the procedure and improve the rate of~     first attempt success.~   "
22152|NCT03277079|"~     It remains unknown if the association between moderate to low intensity statin therapy and~     ezetimibe and nutraceuticals might have a therapeutic role in high-intensity statin~     intolerant patients~   "
22153|NCT03277066|"~     A 4-week, Randomized, Double-blind, Multicenter, Placebo-controlled Phase 2 Study to Evaluate~     the Efficacy and Safety of HP-5000 in Subjects with Osteoarthritis (OA) of the Knee~   "
22154|NCT03277053|"~     A randomized control trial on patients undergoing laparoscopic colorectal resection in an~     Enhanced Recovery Program (ERP). The intervention is delivered via an electronic application~     containing guidelines, information, and tailored feedback. The hypothesis is that the~     application will improve adherence to the ERP.~   "
22155|NCT03277040|"~     Food is widely understood as a cornerstone of health, however multiple barriers stand between~     well-intentioned, well-informed consumers and the adoption of healthier dietary practices.~     This mixed-methods randomized controlled trial (RCT) will measure the impact of offering a~     Community Sustained Agriculture (CSA) share as an employee benefit on household food~     environments (diets), eating behaviors, and lifestyles.~   "
22156|NCT03277027|"~     The primary aim of this study is assessing physical activity, the quality of sleep and health~     related quality of life in children with cerebral palsy, and parenting stress of caregivers~     of the children with cerebral palsy in Korea.~   "
22184|NCT03276663|"~     Growth of healthy term formula-fed infants who receive a single feeding regimen consisting of~     an existing partially hydrolyzed starter formula, then subsequently fed a partially~     hydrolyzed follow-up formula over the first year of life.~   "
22344|NCT03274557|"~     Prospective randomized controlled study using radio-frequency microtenotomy or physical~     therapy (eccentric training) for treatment of Achilles tendinose~   "
22158|NCT03277001|"~     AECOPD increases the risk of VTE.VTE prevention is a long way to go for high-risk VTE~     patients in China.The incidence of AECOPD complicated with VTE in Asian population is high~     and the mortality rate is high.Rivaroxaban, a new oral anticoagulant, has been widely used in~     the treatment and prevention of VTE.However the question about the efficacy and safety of new~     oral anticoagulant compared with LMWHs for the prevention of symptomatic VTE and VTE-related~     death post-hospital discharge in high-risk AECOPD patients is still unknown. Thus this study~     is to evaluate if the prophylactic anticoagulation effect by Rivaroxaban is non-inferiority~     than Enoxaprine in high risk AECOPD and to evaluate the safety of using Rivaroxaban to~     prevent VTE in high risk AECOPD comparing with Enoxaprine.~   "
22159|NCT03276988|"~     The purpose of this study is to determine the safety, tolerability, and pharmacokinetics in~     patients with total thyroidectomy or near total thyroidectomy of an investigational rhTSH~   "
22160|NCT03276975|"~     The goal of this randomized controlled trial (RCT) is to compare the efficacy of CT~     fluoroscopy-guided targeted epidural patching for treatment of imaging-confirmed spinal CSF~     leaks to that of a simulated procedure without patching material in patients with spontaneous~     intracranial hypotension.~   "
22161|NCT03276962|"~     The study intends to establish proof of concept for a fractional dose schedule under~     conditions of natural exposure in children 5-17 months old at first vaccination. The study~     also aims to establish the role of third dose spacing in a fractional dose schedule, describe~     the effect of an earlier full fourth dose at Month 14 and describe the effect of multiple~     fractional or full yearly doses.~   "
22162|NCT03276949|"~     This study is to evaluate the capability of Raman spectroscopy as a non-invasive method for~     monitoring concentrations of glucose by illuminating a small spot on the skin, collecting and~     analyzing the return light. The glucose measurements obtained by Raman Spectroscopy are~     correlated with those obtained using YSI glucose analyzer and ACCUCHECK instruments.~   "
22163|NCT03276936|"~     The primary objective is to show that open-label extended treatment with FMX103 1.5%, for up~     to an additional 40 weeks, is safe and well tolerated.~   "
22164|NCT03276923|"~     This multi-site registry, centered at Duke University, will enroll pregnant women with~     autoimmune and rheumatologic diseases.~      The main goal of MADRA is to identify ways to improve the health of women with rheumatic~     diseases and their babies during pregnancy.~      Prior studies demonstrate the importance of increase inflammation prior to and during~     pregnancy on these outcomes. The future research will seek to better define these risk~     factors and to identify ways to may improve them.~   "
22165|NCT03276910|"~     The main objective of this research is to demonstrate the possible use of erythroferrone~     (ERFE) as a potential marker of recombinant human erythropoietin (rHuEpo) use to be included~     in the Athlete Biological Passport (PBA) developed by the World Anti-Doping Agency (WADA).~   "
22166|NCT03276897|"~     Efficacy and Tolerance Evaluation of arevitalizing face treatment consisting of a day and a~     night cream~   "
22167|NCT03276884|"~     To compare growth and tolerance of healthy term infants fed two amino acid-based infant~     formulas.~   "
22168|NCT03276871|"~     The purpose of this study is to determine if the surgical technique for creation of~     extraperitoneal space during laparoscopic TEP inguinal hernia repair (telescopic dissection~     or balloon dissection) has an impact on operative times, early postoperative pain scores,~     surgical complications and rate of hernia recurrence following laparoscopic TEP inguinal~     hernia repair.~   "
22169|NCT03276858|"~     This single-center study will be conducted in 3 phases: a single-ascending dose phase (up to~     8 cohorts, 8 subjects/cohort), a multiple-dose phase (up to 5 cohorts, 9 subjects/cohort),~     and a midazolam drug-drug interaction phase (one cohort of 8 subjects).~   "
22170|NCT03276845|"~     Despite advances in mammographic technique, mammography is limited in the detection and~     diagnosis of breast lesions with respect to sensitivity and specificity. In recent decades,~     ultrasound has become an essential adjunct to mammography for the further characterization of~     mammographically detected or palpable lesions or in the diagnosis of patients with dense~     breasts.~      However, in spite of defined morphological criteria for the differentiation of benign from~     malignant lesions, ultrasound of the breast also shows limitations regarding sensitivity and~     specificity. On the one hand, benign lesions may have one or more malignant characteristics~     and thus require a biopsy. On the other hand, malignant lesions can also show benign~     characteristics and thus make an accurate assessment difficult.~      To overcome these limitations, newer sonographic methods have been developed. These include~     elastography, color and power Doppler imaging, contrast enhanced imaging and 3D sonography.~      The application of elastography is based on the fact that cancer has a higher stiffness than~     healthy breast parenchyma.~      In addition, cancers are characterized by neoangiogenesis and thus generally show an~     increased vascularization in color and power Doppler. The detection of neoangiogenesis can be~     improved by the application of contrast agents. The latter provides both morphological and~     functional information about tumors, through the study of the contrast agent kinetics.~      Finally, 3D sonography allows for tumors to be examined in a third, coronal plane. This way,~     the interaction between the tumor and the surrounding healthy tissue can be better~     appreciated.~      The objective of this study is the evaluation of suspicious (classified as BI-RADS 4 and 5)~     breast lesions by using high-resolution sonography, including elastography, color/power~     Doppler, contrast agent application and 3D sonography. Both morphological and functional~     information can thus be obtained. The primary hypothesis of this study is that this~     multiparametric approach will improve the detection and characterization of breast lesions.~   "
22171|NCT03276832|"~     This pilot trial studies the side effects and how well imiquimod and pembrolizumab work in~     treating patients with stage IIIB-IV melanoma. Imiquimod may stimulate the immune system.~     Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells~     to grow and spread. Giving imiquimod and pembrolizumab may work better at treating melanoma.~   "
22172|NCT03276819|"~     This is a multicenter minimal risk or burden prospective 3-cohort follow-up and monitoring~     study that aims to collect clinical, socio-psychological, medico-economics data and~     biospecimens for patients with oral potentially malignant lesions (OPML) or resectable head~     and neck squamous cell carcinoma (HNSCC) :~        -  Cohort A: OPML patients.~        -  Cohort B (specific design): smokers (adults who have smoked at least 100 cigarettes in~          their lifetime) motivated to quit - either current smokers (who currently smokes~          cigarettes every day (daily) or some days (nondaily)) or former smokers (adults who have~          smoked at least 100 cigarettes in their lifetime, but say they currently do not smoke)~          who stops smoking within 3 months prior to the diagnosis - with a resectable HNSCC~          requiring postoperative radiotherapy or chemoradiation.~        -  Cohort C: Patients with resectable HNSCC non-eligible to cohort B.~      The primary objective of this study is the identification of biomarkers (predictive of~     malignant transformation or second primary tumor) and new strategies for prevention and~     therapy, mainly through extensive genomic, epigenomic and immune characterization of OPML and~     HNSCC.~   "
22173|NCT03276806|"~     Current smokers who undergo annual low dose CT (LDCT) lung cancer screening and successfully~     quit smoking derive the greatest reduction in lung cancer mortality. Unfortunately, those at~     highest risk of lung cancer death- those with low socioeconomic status, blacks, and current~     smokers- are the same individuals that typically have reduced access to preventive healthcare~     such as smoking cessation services and screening tests. Furthermore, patients from~     underserved communities often have lower health literacy, less awareness of lung cancer~     screening, and a poor understanding of the trade-offs of LDCT screening. In 2015 the Center~     for Medicare and Medicaid Services began requiring (1) a shared decision-making (SDM)~     discussion including use of a patient decision aid and (2) smoking cessation counseling in~     order to receive reimbursement for LDCT screening. There is little guidance, however, to help~     healthcare systems implement this requirement. Furthermore, primary care physicians (PCPs)~     report time constraints, competing demands, and knowledge deficiencies as barriers to~     optimizing utilization of LDCT screening.~   "
22174|NCT03276793|"~     This study will include 60 subjects with medication-refractory depression undergoing~     transcranial magnetic stimulation (TMS) to the left dorsal lateral prefrontal cortex (DLPFC).~     In order to obtain good quality data and account for attrition, 80 subjects will be~     recruited. Subjects will be recruited from the Clinical Program of FDA approved TMS at the~     Berenson-Allen Center and the Butler TMS Clinic (40 per site). Subjects will undergo an~     hour-long MRI scanning session, an optional DNA-sample collection, up to three 20 minute~     neuronavigation sessions for marking the site of TMS stimulation, questionnaires, and a~     behavioral testing battery before and after their TMS treatment course. The task battery will~     last 45-60 minutes and consist of the Emotion Conflict Resolution (ECR) task, Multi-Source~     Interference Task (MSIT), War Game (Gambling) task, and Associative Learning with Reversal~     task. Subjects' scores on the Hamilton Depression Rating Scale (HDRS) and Beck Depression~     Inventory (BDI) will also be assessed before and after the TMS course. MRI data will be~     utilized to identify brain regions whose connectivity to the stimulation site co-varies with~     the aforementioned objective measures of symptom improvement.~   "
22175|NCT03276780|"~     To determine the preliminary impact on Nicotine Replacement Therapy (NRT)adherence and~     examine the underlying mechanisms of action associated with adherence.~   "
22176|NCT03276767|"~     The primary purpose of the current study is to compare the effect of SMS-textmessage vs~     e-mail reminders on user engagement and proportion of reported quit attempts in an online~     smoking cessation intervention.~   "
22177|NCT03276754|"~     Prospective multicenter observational study, to evaluate the impact of routine clinical~     practice vaccination with PCV13 on the reduction of the risk of moderate/severe COPD~     exacerbations~   "
22178|NCT03276741|"~     A RCT to evaluate the impact of unrestricted low fat, low residue oral intake during labor on~     maternal and neonatal outcomes as well as maternal satisfaction.~   "
22179|NCT03276728|"~     To evaluate the safety and tolerability of ascending single (Part A) and ascending multiple~     (Part B) doses of AMG 986 in healthy subjects, who received AMG 986 by constant intravenous~     (IV) infusion or oral (PO) administration and of ascending multiple PO doses of AMG 986 in~     heart failure patients (Part C).~   "
22180|NCT03276715|"~     Malignant pleural effusion can occur in up to half of the patients with metastatic disease.~     It can cause shortness of breath to patients and so far there is no protocol on its~     management.~      The study is looking at patients with malignant pleural effusion and aims to identify its~     prognostic factors.~      Pleural fluid and blood analysis will be performed as in the standard of care and results~     will be collected at the start of diagnosis. This will not affect subsequent management plan.~     Patients' disease course will be followed up and progress data will be collected. Data will~     then be analysed to identify relevant prognostic factors.~   "
22181|NCT03276702|"~     It has been shown that the genomic landscape of tumors can dramatically change at the time of~     disease progression. This suggests that therapies aimed at treating the tumor at diagnosis~     may not be relevant at the time of relapse. Obtaining fresh tissue at the time of relapse~     could facilitate the identification of potential targets that have developed through~     mutational evolution of the primary tumor and would provide an unprecedented opportunity to~     expand the library of patient derived xenografts (PDX) that are available for comprehensive~     preclinical testing in the setting of relapsed disease.~      The purpose of this observational study is to prospectively collect fresh tumor tissue from~     pediatric patients with solid tumors who have recurrent or progressive disease and submit~     this tissue for comprehensive genomic analysis using clinically available CLIA-certified~     platforms that include WGS, WES and RNAseq, and to assess the reasons for a patient and/or a~     parent for making a decision to proceed with or refuse a re-biopsy procedure in the presence~     of a recurrent or progressive solid tumor. The data obtained will be used to develop new~     novel therapies that incorporate new pharmacological agents in pediatric solid tumors.~      PRIMARY OBJECTIVES:~        -  To prospectively collect fresh tumor tissue from pediatric patients with solid tumors~          who have recurrent or progressive disease and submit this tissue for comprehensive~          genomic analysis.~        -  To assess the reasons a patient and/or a parent make the decision to proceed with or~          refuse a re-biopsy procedure in the presence of a recurrent or progressive solid tumor.~      SECONDARY OBJECTIVES:~        -  To estimate refusal and acceptance rates for re-biopsy and the parental/patient~          attitudes towards a re-biopsy.~        -  To estimate the incidence of complications associated with biopsy.~        -  To estimate the percentage of procedures that fail to obtain adequate tissue for genomic~          analysis.~   "
22182|NCT03276689|"~     Introduction Treatment of neuropathic pain has been a goal of numerous research projects for~     the last half century, with overall disappointing results. These poor achievements are in~     contrast with substantial advancements in the understanding of pain mechanisms, and numerous~     molecules developed to tackle them. The need to better identify patients likely to respond to~     treatment comes from the neuropathic pain experts in regards to the pharmacological domain.~      The basic assertion of this project is that the pain modulation profile is altered in pain~     patients toward a pro-nociceptive mode, and that the specific single or multiple dysfunctions~     of pain modulation that underlie this pro-nociceptivity should be targeted by therapeutic~     lines that can reverse the modulation back toward eu-nociceptivity.~      The aim of this amendment is to demonstrate that pain treatment efficacy for painful diabetic~     neuropathy can be optimized by individualizing pharmacological treatment choice along 'fix~     the dysfunction' concept~   "
22183|NCT03276676|"~     The hypothesis of this exploratory clinical trial in patients with high-grade a primary brain~     tumor who receive chemoradiation is that the PET imaging agents [18F]Fluciclovine and/or~     [18F]FLT will be a better predictor of tumor response than standard MRI based brain tumor~     response criteria. When used in conjunction, the two PET agents may be better able to predict~     tumor aggressiveness and thus overall survival than the use of individual-tracer PET~     biomarkers. This may eventually lead to improved assessment of response (including time to~     progression and overall survival) and differentiation of tumor recurrence/progression from~     treatment effect (pseudoprogression).~   "
22185|NCT03276650|"~     Since its first description in 1971, diagnosing adult-onset Still's disease (AOSD), a rare~     multisystemic disorder considered as a multigenic autoinflammatory syndrome, remains~     challenging. Rarely, AOSD may present severe systemic manifestations and require intensive~     care. The main purpose of the Stil ICU study is to make the first description of the~     epidemiology of critically ill AOSD patients. The investigators will use a retrospective~     cohort study design with dual recruitment strategies: (1) via the AOSD referral centres~     network and (2) via a French academic medical ICU network.~   "
22186|NCT03276637|"~     The MilSeq Project is a nonrandomized, prospective pilot study of whole exome sequencing~     (WES) in the U.S. Air Force. The purpose of this study is to explore the implementation of~     WES into clinical medical care in the military health system.~   "
22187|NCT03276624|"~     Coronary artery bypass grafting (CABG) among patients with reduced myocardial function~     remains a surgical challenge despite improvement in surgical technique, myocardial protection~     and postoperative care. Such cases are considered as high risk and associated with a higher~     peri-operative mortality than those with normal left ventricular function (LVF). Patients~     with low EF are at higher risks of sudden death, ventricular arrhythmia, and worsening heart~     failure due to recurrent ischemia. Therefore,early recognition of patients at risk for a~     worse outcome plays a pivotal role in the decision making process, allowing the prompt~     institution of an adequate support.~   "
22188|NCT03276611|"~     Obstructive sleep apnea (OSA) is a frequent sleep-related breathing disorder with an~     incidence of 5-20% in the middle-aged population in Europe and Northern America . plumonary~     hypertension is present in 12%-34% of patients with osa.continous positive air way pressureis~     the main standard treatment ofOSA.Echocardiograghy is the most common non invasive imaging~     method for assessment the effect on right ventricular function.~   "
22189|NCT03276598|"~     Blood pressure variation and the risk of essential hypertension have an important genetic~     component. In most cases susceptibility to essential hypertension is likely determined by the~     action of more than one gene.~      The identification of genes causing susceptibility to hypertension is important, since it~     would give new tools for the diagnosis and enable better etiological classification and~     specific treatment of the disease.~      The innovation of this study is to use the response to antihypertensive therapy as an~     intermediate phenotype.~      In the study, each subject uses one of four antihypertensive drugs, each as a monotherapy in~     a rotational fashion, for 28 days in a randomized order. The antihypertensive drugs to be~     tested include a thiazide diuretic, a beta-adrenergic antagonist, an angiotensin-II receptor~     antagonist and a calcium channel blocker. The drugs that are selected for the study are~     typical representatives of their groups and long-acting, and the dosages are sufficient but~     well tolerable.~   "
22190|NCT03276585|"~     The investigators hypothesized that depression is associated with home sleep EEG, subjective~     sleepiness and insomnia symptoms. To test this, the investigators plan to perform sleep~     examination with single channel EEG, in combination with questionnaire survey for insomnia,~     sleepiness, depression and job stress to Koka city government employees.~   "
22191|NCT03276572|"~     This is an open−label, single−center Phase I dose escalation study designed to determine the~     dose−limiting toxicity (DLT) and the maximum tolerated dose (MTD) of 225Ac−J591 in a single~     dose regimen.~   "
22192|NCT03276559|"~     Intensive Care Units (ICU) are stressful places where life-and-death medical decisions are~     made and patients and patients' caregivers are exposed to potentially traumatic experiences.~     As the number of life-prolonging procedures administered to the patient rises, the patient's~     quality of life falls. Thus, interventions to improve the quality of life and care of ICU~     cancer patients are needed.~      EMPOWER is a cognitive-behavioral, acceptance-based intervention to reduce experiential~     avoidance of unpleasant thoughts and feelings related to thinking about patient death. By~     reducing caregivers' experiential avoidance, EMPOWER removes a barrier to advance care~     planning (ACP), including the completion of advance directives, such as Do Not Resuscitate~     (DNR) orders. EMPOWER should improve EoL care that enhances patient quality of life while~     also empowering caregivers to cope with a loved one's impending death and adjust following~     the patient's ICU death or discharge. Specifically, investigators aim to:~        -  1: Determine feasibility, tolerability, acceptability, and preliminary effects of~          EMPOWER on caregiver mental health.~        -  2: Estimate the effects of EMPOWER on patient outcomes in the month following the ICU~          admission.~      Hypothesis 1: caregivers who receive EMPOWER will have significantly lower PTSD symptom~     levels when compared to usual care condition.~      Hypothesis 2: Patients whose caregivers receive EMPOWER will have a higher rate of advance~     care planning, a lower rate of intensive care and a better quality of life/ death.~      Investigators will randomize 60 caregivers of terminally, critically ill and uncommunicative~     cancer patients to EMPOWER or usual care. Assessments will occur pre-intervention,~     immediately post-intervention, and then 1 month and 3 months from baseline.~   "
22193|NCT03276546|"~     More information is needed about effective ways to help people begin to change their~     lifestyle behaviours, particularly physical activity and diet. The investigators propose to~     test a 'tool' that can be used to guide discussions between people and health professionals~     about their physical activity and diet habits, so that people may be supported better in~     making decisions about why and how they might begin to fit more exercise and healthy food~     into their daily routines and make long-term changes. The investigators will explore the~     feasibility of using this tool in general practice, reviewing behaviours after 1 and 3~     months. Patients' and healthcare professionals' views of its use and how it influenced~     decisions will inform development of the tool's design and a study of its effectiveness in~     helping people to begin to change their behaviour and achieve healthy lifestyles.~   "
22205|NCT03276390|"~     Hispanic/Latino patients with end-stage renal disease are disproportionately less likely to~     get a kidney transplant, and specifically, a living donor kidney transplant (LDKT), compared~     to non-Hispanic whites. Accordingly, without LDKTs, Hispanics experience longer transplant~     waiting times, shorter patient and graft survival, and worse quality of life. Cultural~     beliefs and linguistic barriers contribute to the disparity in LDKTs. The objective of the~     proposed study is to implement and evaluate Northwestern Medicine's® Hispanic Kidney~     Transplant Program, a culturally-competent transplant center-based intervention, at two~     transplant centers serving large Hispanic populations. The proposed study will provide~     valuable knowledge about the potential to rapidly disseminate the HKTP as a novel approach to~     increase Hispanic LDKTs nationally.~   "
22194|NCT03276533|"~     Objective: The present study was to evaluate the effects of dexmedetomidine alone, lidocaine~     alone and their combined infusion on postoperative inflammation cytokines after Laparoscopic~     hysterectomy.~      Methods: Investigators enrolled 160 women with American Society of Anesthesiologists (ASA)~     physical status I and II, aged 40-65 years, and scheduled for elective laparoscopic~     hysterectomy with general anesthesia from October 2017 to August 2018. The participants were~     randomly assigned into four groups(n=40 each group): group CON received normal saline~     infusion, group LIDO received lidocaine infusion (1.5 mg/kg loading, 1.5 mg/kg/h infusion),~     group DEX received dexmedetomidine infusion (0.5 µg/kg loading, 0.4 µg/kg/h infusion) and~     group LIDO+DEX received lidocaine (1.5 mg/kg loading, 1.5 mg/kg/h infusion) and~     dexmedetomidine infusions (0.5 µg/kg loading, 0.4 µg/kg/h infusion). The four groups received~     an IV bolus infusion of normal saline, lidocaine, dexmedetomidine and lidocaine combined with~     dexmedetomidine respectively, over 10 minutes before induction of anesthesia, followed by a~     continuous IV infusion of normal saline, lidocaine, dexmedetomidine and lidocaine combined~     with dexmedetomidine until abdominal wound closure, respectively. Interleukin-6 and tumor~     necrosis factor-α levels in serum were measured at different time points: before~     administration of drugs (T1), the end of surgery (T2), postoperative 2 hour (T3) and~     postoperative 24 hour (T4).~   "
22195|NCT03276520|"~     Background: Alcohol use disorders represent a major health burden. Efforts aiming at reducing~     alcohol-related harm include early detection of those with risky drinking habits as well~     detection of early relapse in patients with alcohol dependence who are detoxified and~     committed to abstinence. Recently, ethyl glucuronide has been proved to be a good biomarker~     for the detection of recent drinking. However, to date, no randomized diagnostic trial has~     tested its impact on drinking outcomes. The aim of this study was to assess, with a~     randomized design, the implications of ethyl glucuronide screening on alcohol outcomes,~     compared to screening with a low-sensitivity biomarker such as ethanol.~      Methods: alcohol dependent outpatients were randomized to either 24 weeks of continuous~     screening with ethyl glucuronide or ethanol. Patients were aware of screening methods and~     results. After 24 weeks, all participants were screened with ethyl glucuronide. Self-reports~     were also gathered. A logistic regression model was performed comparing the rate of ethyl~     glucuronide positive results at study end between groups. Generalized estimating equations~     were performed to evaluate the descending rate of EtG positive patients in the EtG group,~     measured month to month.~   "
22196|NCT03276507|"~     The MUSE study is a prospective observational cohort study of patients referred to pulmonary~     and/or cardiology specialty clinic for evaluation of shortness of breath or dyspnea. Patients~     will undergo all pertinent testing and will be required to fill out a number of epidemiologic~     and quality of life related questionnaires. Follow up will continue for at least one year.~   "
22197|NCT03276494|"~     Hypertonic saline is used to treat elevated intracranial pressure. Intraosseous vascular~     access has been used to administer fluids and medications. This study combines these to~     administer 3% hypertonic saline via IO.~   "
22198|NCT03276481|"~     The purpose of this study is to study taste disturbances on patients with myeloma who~     received high dose melphalan.~   "
22199|NCT03276468|"~     This study is a multicenter phase II trial which primary objective is to assess the~     anti-lymphoma activity of atezolizumab associated with a BCL-2 inhibitor (GDC-199,~     venetoclax) and an anti-CD20 monoclonal antibody (obinutuzumab) in three separate cohorts:~        -  relapsed/refractory follicular lymphoma (FL) patients~        -  relapsed/refractory aggressive (DLBCL) lymphoma patients~        -  relapsed/refractory other indolent (iNHL) lymphoma patients (MZL and MALT)~   "
22200|NCT03276455|"~     This is a single group, open label study in 10 subjects who are 8 years of age or older with~     beta-thalassemia major. The objective of this study is to evaluate the safety and efficacy of~     autologous hematopoietic stem cell transduced with lentiviral vector for the treatment of~     beta-thalassemia major.~   "
22201|NCT03276442|"~     Metabolism is increasingly recognized as being highly regulated by anticipatory biological~     rhythms (circadian rhythms or biorhythms), which are driven by molecular feedback loops,~     and which are approximately 24 hours long (circa diem). These circadian rhythms exist both~     centrally, in the brain, but also in the periphery, and are specific to many tissues~     depending on their main biological function or functions. Whereas these circadian rhythms~     have been thoroughly characterized in other organisms, their role in humans remain poorly~     understood, partly because of the difficulty in studying these rhythms in peripheral tissues.~     The investigators therefore aim to characterize these rhythms in primarily skeletal muscle~     and adipose tissue in healthy young volunteers (using the so-called constant routine~     paradigm), and how these rhythms interact with one another at various genetic and molecular~     levels. At the same time, the investigators aim to study how an unhealthy vs. healthy diet~     can alter these circadian rhythms, and how they interact with circadian rhythms in other~     tissue compartments such as those expressed by blood cells.~   "
22202|NCT03276429|"~     In the light of a new era in the management of lung cancer this non-interventional study~     intend to capture all the epidemiological, clinical, pathological, molecular and treatment~     parameters of non-small cell (NSCLC) and small cell (SCLC) lung cancer patients from a~     tertiary Oncology Clinic in an Electronic Data Base (EDB).~   "
22203|NCT03276416|"~     This observational study aims at developing and validating a simple questionnaire to be~     routinely applied in the clinical practice, for the evaluation of the quality of life in~     children with concomitant asthma and allergic rhinitis. The study consists of two phases:~      Phase 1: Development of the RAPP-children questionnaire starting from the validated~     RHINASTHMA-children questionnaire.~      Phase 2: Administration and validation of the RAPP-children questionnaire. 130 children with~     concomitant asthma and allergic rhinitis will be followed-up for one month. Both at baseline~     and after one month, the RAPP children and several other standardized questionnaires will be~     administered.~   "
22204|NCT03276403|"~     The validity of several functional parameters, which could be included in a new PGD scoring~     system, will be tested in a prospective pilot study of 80 consecutive bilateral lung~     transplant recipients in high volume lung transplant centers. Functional parameters will be~     collected at different time points within the first 72hrs after lung transplantation and~     their accuracy in predicting clinical outcome as well as their correlation with lung water~     content (measured by PiCCO) will be tested. Insights will serve to generate a hypothesis (a~     novel PGD score), which can then be tested in future prospective trials.~   "
22206|NCT03276377|"~     The primary objective of this study is to determine whether patients usually taking Vitamin K~     Antagonists (VKAs) exhibit a poorer global cognitive performance than control patients~     (matched on age, gender and indication for anticoagulation) taking direct oral anticoagulants~     (DOACs).~      The secondary objectives are:~        -  to determine whether patients usually taking VKAs are more likely to have moderate to~          severe cognitive disorders than matched controls taking DOACs.~        -  to determine whether VKAs intake is associated with poorer executive functions.~        -  to determine on CT scans whether the VKAs intake is associated with a greater volume of~          vascular calcifications in the brain compared to the use of DOACs.~   "
22207|NCT03276364|"~     Point-of-care ultrasound (POCUS) has been found to be useful for aiding in the prediction of~     fluid responsiveness. It is unknown if trainees can effectively utilize this tool to improve~     their assessment of fluid responsiveness.~      In this prospective, observational study, pulmonary and critical care fellows are asked to~     make 2 assessments of fluid responsiveness in adults with shock: (1) based on clinical exam~     alone (Clinical) and (2) after performing a POCUS (Clinical + US). The accuracy of their pre-~     and post-ultrasound assessments are compared using a bioreactance monitor and passive leg~     raise test as the gold standard of fluid responsiveness in this study.~   "
22208|NCT03276351|"~     This is a prospective randomized control trial that aims to investigate fixation of implants~     after revision total knee replacement. The investigators are comparing long-stemmed revision~     implants with hybrid or full cementation to short-stemmed primary implants with augment using~     a special type of x-ray imaging (radiostereometric analysis) to assess implant movement over~     time. The investigators are also comparing costs and patient-reported outcomes between the~     groups.~   "
22209|NCT03276338|"~     The intervention is based on social cognitive theory and theory of empowerment education and~     was developed using community-based participatory research (CBPR). This study is a result of~     a long-term community-university partnership that has used and will continue to use CBPR~     throughout all phases of research. A total of 21 Latino MSM in rural NC have been screened~     and recruited to serve as LHAs. The CBPR partnership selected LHAs based on qualities of~     natural helpers and informal leaders and having existing social networks of other Latino MSM.~     Eight members of each LHA's social network have been screened and recruited to participate as~     well. The LHAs, coupled with their social networks, have been randomized to intervention or~     delayed-intervention groups. LHAs (n=11) in the intervention group were trained and serve as~     LHAs within their social networks in Year 2. Delayed-intervention LHAs (n=10) receive the~     same LHA training and serve as LHAs within their social networks in Year 3. Quantitative~     assessment data is collected from each LHA (n=21) and the 8 members of his social network~     (n=189) longitudinally at: (1) baseline, (2) immediate post-intervention, and (3) 12-month~     follow-up. This is an intent-to-treat study, in which participant data are analyzed based~     on their randomization group.~      The investigators hypothesize that participants in the HIV prevention intervention, relative~     to those in the delayed intervention comparison group, will demonstrate (1) increased~     self-reported use of condoms during sexual intercourse and (2) increased self-reported HIV~     testing.~      The results and products from this study will be disseminated to inform public health~     practice, research, and policy. Results and products will include: (1) a Spanish-language~     intervention that is: culturally congruent and gender-specific; designed to reduce HIV risk~     among Latino MSM; and ready for dissemination and adaptation; (2) a deeper understanding of~     HIV risk and intervention among Latino MSM; and (3) insight into a CBPR process that includes~     community members, organizational representatives, and academic researchers.~   "
22210|NCT03276325|"~     Intraoperative pain, nausea, vomiting, hypotension, bradycardia are known side effects during~     lower abdominal surgery under spinal anesthesia, Time to 2 segment regression of sensory~     block and duration of effective analgesia prolonged with intrathecal (IT) 0.4 mg nalbuphine &~     IT 0.8 mg nalbuphine, but the incidence of side-effects was significantly higher with IT 0.8~     mg nalbuphine compared with (IT) 0.4 mg nalbuphine.~   "
22211|NCT03276312|"~     This is a randomized controlled monocentric study on 114 diabetic patients with the aim of~     evaluating the efficacy of the lipofilling with Lipogems® system in diabetic patients that~     are candidates for a minor amputation in the foot. In particular, it will be evaluated~     whether the lipofilling will be able to shorten the healing times and to reduce the number of~     major amputations, with consequent positive impact on the quality of life. Patients will be~     randomized to the treatment group with Lipogems® (local injection of autologous~     micro-fractured adipose tissue) or to the control group, thus, treatment according to~     standard clinical practice.~   "
22212|NCT03276299|"~     Evaluation of the learning and encouragement effect on six minutes walking test in children~     under 12 years~   "
22213|NCT03276286|"~     This feasibility study will assess the effects of the Nativis Voyager therapy in patients~     newly diagnosed with GBM. The study will enroll and treat up to 11 subjects and will be~     combined with standard of care radiotherapy and temozolomide.~   "
22214|NCT03276273|"~     The severity of minimal dialysis disequilibrium syndrome (DDS) is currently detected and~     graded clinically using clinical criteria. Bispectral Index (BIS), an electroencephalographic~     (EEG) derived parameter is widely used in anesthesia and Critical Care setting to detect~     effects of anesthetic/hypnotic drugs. The aim of our study was to assess the discriminative~     power of BIS monitoring to accurately detect DDS.~   "
22215|NCT03276260|"~     Medasense's Pain Monitoring Device (PMD) is a novel non-invasive, bedside stand alone,~     continuous monitor that is designed to provide real-time information about changes in the~     nociception level of patients under general anesthesia during surgical procedures.~      The PMD-200 System is based on real-time data acquisition and processing of physiological~     signals. The system displays the NOL index (a single numerical index) which is computed from~     recorded physiological parameters based on a proprietary algorithm.~   "
22216|NCT03276247|"~     Analyzed iron status, HFE mutations and ethnicity for women in five primary care centers in~     the United States and Canada using de-identified data from the HEIRS study.~   "
22217|NCT03276234|"~     Is there a relationship between serum sodium level and mean platelet volume (MPV) value in~     patients undergoing transurethral prostate resection (TUR)?~   "
22218|NCT03276221|"~     This study will use a randomized controlled design to test whether 30 days of cannabis~     abstinence, compared to 30 days of monitoring, is associated with improvements in cognitive~     functioning. Non-using controls will also be enrolled to determine the clinical significance~     of any cognitive improvements with abstinence.~   "
22219|NCT03276208|"~     This trial will examine the contribution of massage therapy and mindfulness to~     tobacco-smoking women in the third trimester of pregnancy.~   "
22220|NCT03276195|"~     This study is aimed to carry out a systematic study to examine the effects of genetic~     variants (genetic modifiers) other than TSC genes on phenotypic variability in familial TSC~     patients (affected parent, child and unaffected siblings) and sporadic TSC.~   "
28669|NCT03191734|"~     Single arm, multi-center prospective clinical trial to determine the safety and effectiveness~     of the AQUABEAM System in the treatment of benign prostatic hyperplasia (BPH) in men 45 to 80~     years of age.~   "
22221|NCT03276182|"~     This study will compare cataract patients before and after phacoemulsification. Evaluations~     will be performed before and 1 and 3 months following cataract surgery, including parameters~     of dry eye syndrome and MGD. Dry eye syndrome parameters included TBUT, Schirmer's test type~     I, Oxford staining score, and the Ocular Surface Disease Index (OSDI) Questionnaire. MGD~     parameters consisted of lipid layer thickness (LLT), lid margin abnormality, meibum quality,~     meibum expressibility, MG orifice obstruction, MGD stage, and MG dropout.~   "
22222|NCT03276169|"~     A total of 105 patients with persistent atrial fibrillation(AF), that lasting longer than one~     year and planned to undergo surgical treatment, will be allocated into three groups. These~     patients will receive left atrial appendage closure(LAAC), radiofrequency ablation under the~     guidance of 3D mapping and LAAC combined with radiofrequency ablation, respectively~     (allocation ratio, 1:1:1). Real-time 3D ultrasound and 2D ultrasound examinations and~     measurement of left ventricle(LV) and left atrial(LA) function are carried out for all~     patients before the operation, and at 1, 2, 3 and 4 weeks and 2, 3, 6, 9 and 12 months after~     the operation. All ultrasound data will be stored and a professional director from the~     ultrasound room will be invited for quantitative analysis. Indicators for ultrasonography~     include: LV ejection fraction(LVEF), LV end-diastolic volume, Stroke volume, left atrial~     anterior and posterior diameter, left atrial volume, left atrial volume index, mitral e , E~     peak, A peak, velocity time integral (VTI), left atrial ejection fraction, left atrial~     strain, and strain rate. Blood samples are extracted in all patients to detect type B~     natriuretic peptide before the operation and at 1, 2, 3 days and 1,3,6,12 months after the~     operation. Blood samples are extracted in all patients to detect routine blood, coagulation,~     D-D dimmer,Inflammatory markers (hsCRP） and other biochemical parameters before the operation~     and at 1, 2, 3 and 4 weeks and 1, 2, 3,6and 12 months after the operation. At the same time~     in operation LA pressure in all patients will be measured preoperatively and postoperatively.~     This study will clarify the short-term and long-term changes of LA pressure and function of~     patients with persistent AF after LAAC, and whether changes in left atrial pressure and~     function are related to inflammation indicators. This study will also to observe whether the~     coagulation indexes changed after LAAC that can be used to know whether the LAAC activates~     the coagulation system. In addition, this study to investigate the effects of radiofrequency~     ablation combined with LAAC on left atrial pressure and function, changes of blood~     coagulation and inflammatory markers, and to analyze the above findings. At an average~     follow-up of one year, changes in left atrial function, inflammation, coagulation, and~     embolic events were analyzed early (3 months after surgery) and late (1 years after surgery).~   "
22223|NCT03276156|"~     The purpose of this study is to determine the maximum tolerated dose (MTD)and safety of~     Apatinib combined with S-1 as Second-line therapy for patients with advanced gastric or~     gastroesophageal junction adenocarcinoma.~   "
22224|NCT03276143|"~     This study is to compare the study drug BAY1213790 to existing therapies, ie Enoxaparin or~     Apixaban for the prevention of blood clotting and safety in patients undergoing total knee~     arthroplasty (TKA). The study is open-label, but observer-blind for the different doses of~     BAY1213790 administered. This means that it is known which treatment is given, but it is not~     known which dose of BAY1213790 is administered.~   "
22225|NCT03276130|"~     The puropse of this non-interventional register and survey study is to identify the patterns~     of prescribed pain, anti-depressive and anti-anxiety medication and management of pain,~     depression and anxiety for people with haemophilia. The study will be conducted in the Nordic~     countries (Sweden, Norway, Denmark, Finland) and the aim is to cover the entire haemophilia~     population in the register part of the study.~   "
22226|NCT03276117|"~     Paperless partograph wide using in labour room as simple tool in evaluation of labour~   "
22227|NCT03276104|"~     Overall aim of the study is to compare the safety and efficacy of two different surgical~     methods to treat Late In-the-bag intraocular lens dislocation.~   "
22228|NCT03276091|"~     Patients with an immunochemical fecal test positive, have to undergo a colonoscopy. Around~     10% doesn't realize the colonoscopy. This study evaluate the impact of a motivational phone~     call (given by a doctor) to improve colonoscopy participation. And try to understand why this~     patients don't want to make this examination.~   "
22229|NCT03276078|"~     A Phase IIa, open-label, repeat-dose trial to investigate the pharmacokinetics (PK), safety~     and tolerability of single and multiple twice daily doses of inhaled Aclidinium~     Bromide/Formoterol Fumarate 400/12 μg in 20 Chinese male and female patients with stable~     moderate to severe COPD.~   "
22230|NCT03276065|"~     Pilonidal disease is a common painful condition that affects 26 per 100,000 people with an~     incidence of 1.1% in the young male population. Recurrence rates of pilonidal disease after~     initial incision and drainage and after resection have been reported to be 16% and 11%~     respectively. Furthermore, wound issues after resection with primary closure have been~     reported to be as high as 30%. In several retrospective studies and small prospective~     studies, laser hair removal has shown promise as an adjunct therapy to decrease recurrent~     infections and decrease the need for repeat surgery in adults and older adolescents. We are~     performing a randomized control trial of laser hair depilation plus chemical/mechanical~     depilation to examine outcomes related to recurrence of pilonidal disease.~   "
22231|NCT03276052|"~     A Phase I, single centre, randomised, open-label, 2-period ascending dose incomplete block,~     cross-over study to investigate the pharmacokinetics (PK), safety and tolerability of single~     and multiple twice daily doses of inhaled Aclidinium Bromide in healthy Chinese male and~     female subjects.~   "
22232|NCT03276039|"~     This study included 70 subjects divided into 3 groups. Group I included 25 patients with~     NAFLD. Group II included 25 patients with NAFLD and chronic HCV. Group III: included 20~     controls. Abdominal ultrasound was done to patients and controls. Plasma pentraxin-3 (PTX3)~     was measured using ELISA. Comparison between three groups was done regarding plasma~     pentraxin-3. Higher levels of plasma PTX3 were detected in NAFLD patients irrespective of~     presence or absence of chronic HCV infection. Plasma PTX3 could be used as a non-invasive~     test for prediction of metabolic syndrome in the high-risk population with high sensitivity~     and moderate specificity.~   "
22233|NCT03276026|"~     The investigators will track bariatric patients who received sugammadex versus neostigmine in~     the post anesthesia care unit until discharge and assess their length of stay and possible~     nausea / vomiting / hypoxia episodes.~   "
22234|NCT03276013|"~     This is a non-randomized, single arm, multi-center, phase II study of pembrolizumab in~     combination with doxorubicin in subjects with recurrent/metastatic endometrial cancer.~   "
22235|NCT03276000|"~     The objective of the present study is to evaluate the appropriate route of administration of~     misoprostol, either oral or vaginal, for cervical priming to facilitate the procedure of~     office hysteroscopy and reduce patient discomfort to minimum~   "
22236|NCT03275987|"~     This study evaluates the effectiveness of persuasive direct mail materials coupled with an~     incentive for increasing breast and colorectal cancer screening among people enrolled in~     Medicaid. Half of age- and gender-appropriate enrollees received this intervention; the other~     half received the same intervention 15 months later~   "
22241|NCT03275922|"~     To evaluate the efficacy and safety of zolmitriptan nasal spray (ZNS) in the acute treatment~     of migraine headache in subjects ages 6 to 11 years.~      Part 1: Approximately 20 weeks (includes screening and double-blind treatment).~        -  Screening will be performed based on the inclusion exclusion criteria specified in the~          study protocol.~        -  Randomize approximately 288 subjects into the double-blind crossover phase.~      Part 2: Approximately 100 subjects who complete the double-blind crossover phase will enter~     part 2, a 6 month open-label safety extension (OLE).~      Efficacy will be evaluated in the double-blind part of the trial. Safety will be evaluated in~     both the double-blind and the OLE.~   "
22242|NCT03275909|"~     Background: The chronic phase of schizophrenia (CS) that extremely affects the way people~     think, feel and act, underlines the need for effective interventions in patients affected by~     this disorder. The Integrated Psychological Therapy appears in clinical practice guidelines~     as the reference therapy in the treatment of this type of patients. In this paper authors~     propose to include in this program a new module focused on Emotional Management Therapy in~     order to reinforce its effectiveness. The aim of this study is to describe the design of a~     study protocol for a randomized controlled trial in which the objective is to assess the~     efficacy of this modified IPT program in patients with CS compared to treatment as usual~     (pharmacological treatment and social and leisure activities in a Day Care Center).~      Methods/design: This is a randomized study with pre and post-treatment assessment and with a~     6- and 12-month follow-up. Patients are to be randomly assigned to one of two treatments: (1)~     a experimental group: integrated psychological therapy in conjunction with emotional~     management therapy (IPT+EMT), composed of 2-hour biweekly 60 group sessions for 32 weeks, in~     addition to the treatment as usual (TAU), or (2) a control group (treatment as usual).~     Participants in both groups will be evaluated at baseline (pre-treatment) and at~     post-treatment after 8 months. The primary outcome will be that patients in the experimental~     group will show a greater improvement over participants in the control group in reducing~     symptoms and increasing emotional abilities, as well as in improving their quality of life.~     The secondary outcome will be that these results will maintain at the 6- and 12-month~     follow-up in the experimental group.~   "
22243|NCT03275896|"~     Fuchs Endothelial Dystrophy (FED) is a degenerative disease affecting the corneal~     endothelium. The current gold-standard for treatment of severe FED is endothelial~     keratoplasty, wherein a cadaveric Descemet's membrane / endothelium graft is transplanted. In~     this study, the investigators hypothesized that the transplantation of an acellular~     Descemet's membrane (i.e. Descemet Membrane Transplantation, 'DMT') may be equally~     efficacious in promoting recovery of endothelial function in this group of patients.~   "
22244|NCT03275883|"~     The aim of this study is to determine the risk profile of hepatic artery occlusion in liver~     transplant recipients who recieved an aortohepatic conduits, analyzing all consecutive~     cadaveric liver transplantations from July 2007 to 31st December 2016. Medical records will~     be examined and adverse events will be analyzed and categorized using the Clavien-Dindo~     classification and Comprehensive Complication Index.~   "
22245|NCT03275870|"~     Hidradenitis suppurativa (HS) is an under-recognized and debilitating disease. Patients~     suffer from recurring painful abscesses and scarring in their armpits, under the breasts,~     groin and other areas of the body. The cause of the disease is still unknown and common~     treatments are only sometimes effective. Overactivity of the immune system has been~     associated with HS and molecules that cause inflammation have been found in the skin from~     people with HS. Current therapies have long-term risks including antibiotic resistance and~     the investigators aim to find new safe and effective therapies for HS.~      Hydroxychloroquine is a medication that has been used safely in other diseases for many~     years. The investigators believe that hydroxychloroquine has the potential to improve HS~     through multiple mechanisms. Patients enrolled in this study will be treated with~     hydroxychloroquine for 6 months. The investigators also aim to look at the blood of patients~     with HS to look for inflammatory molecules that we could possibly target for the treatment of~     HS. Blood samples will be taken at baseline and following 6 months of treatment.~   "
22246|NCT03275857|"~     It is hypothesized that treatment with cisplatin will reverse emerging refractoriness to~     enzalutimide in patients with CRPC by affecting AR function.~   "
22247|NCT03275844|"~     Congenital malformations correspond to defects in organ morphogenesis identifiable at birth~     or intrauterine life, affecting 2-3% of births. Inside of these malformations, Congenital~     Heart Disease corresponds, in particular, to structural defects of the heart or major blood~     vessels thereof may or may not be associated with other types of syndromes.The resolution is~     usually surgical.~      Also, these patients present a decrease in physical fitness, psychological imbalance, lower~     quality of life and risk significant morbidity and mortality from respiratory infections~     among other problems.~      This can have severe consequences for health in the medium and long term. The habits acquired~     during childhood and adolescence are determinant for the adult life, being relevant levels of~     activity and physical condition, especially in children with pathologies.~      In this way, it is vital to know from childhood parameters that indicate the baseline state~     of these patients according to the levels of physical activity, exercise capacity,~     nutritional status and quality of life. These will be key indicators to take into account in~     the future, to adapt rehabilitation plans that will reduce the effects of their condition.~      The objective of this protocol is To characterize the levels of Activity, and Physical~     Capacity of children with congenital heart disease regularly treated at the Cardiovascular~     Center of Dr. Luis Hospital Calvo Mackenna, compared to healthy children matched by age and~     sex.~   "
22248|NCT03275831|"~     A randomized controlled study (RCT) to investigate the topical effectiveness of PluroGel in~     healing venous and mixed aetiology leg ulcers. Patients with venous and mixed aetiology leg~     ulcers will be identified from hospital outpatient clinics. Willing patients meeting the~     inclusion and exclusion criteria will be consented and assessed in line with standard care.~     Participants will be randomized at Week 2 to receive either topical PluroGel or Intrasite gel~     (an alternative topical hydrogel product) if inclusion criteria is met.~   "
22357|NCT03274388|"~     The purpose of this study is to explore the influence of an innovative combined therapy~     involving optimized protein-rich nutritional therapy and highly effective muscle training by~     personalized whole-body electromyostimulation (WB-EMS) exercise to improve muscle mass,~     strength and functionality, physical capacity, fatigue and quality of life of patients with~     chronic liver disease.~   "
22249|NCT03275818|"~     A two-cohort, fase II, open-label, non-randomized, multicenter clinical trial. 14 sites in~     Spain.~      Cohort 1: Subjects with desmoid tumor (DT) Cohort 2: Subjects with desmoplastic small round~     cell tumor or Ewing sarcoma (DSRCT and ES)~      Nab-paclitaxel (ABRAXANE) will be administered as follows:~      Age ≥ 21 and ≤ 80 years: 125 mg/m2 days 1, 8 and 15 in cycles of 28 days Age ≥ 6 months and ≤~     20 years: 240 mg/m2 days 1, 8 and 15 in cycles of 28 days~      Subjects in the DT cohort will receive a maximum of three cycles. Subjects in the DSRCT and~     ES cohort will receive unlimited cycles until disease progression, the subject begins a new~     anticancer treatment, withdrawal of parent/guardian/subject consent/assent,~     parent/guardian/subject refusal, physician decision, toxicity that cannot be managed by dose~     delay or dose reduction alone or the study ends for any reason.~      The main goal is to determine the objective response rate (ORR), using RECIST 1.1 criteria~     and to determine the clinical benefit rate (CBR), defined as CR+PR+SD for 3 months with~     improvement of pain with at least minimally important difference (MID) of 2 in subjects with~     desmoid tumors (DT cohort) and to determine the objective response rate (ORR) in subjects~     with desmoplastic small round cell tumor and Ewing sarcoma, using RECIST 1.1 criteria (DSRCT~     and ES cohort)~   "
22250|NCT03275805|"~     Children who are diagnosed with Developmental Hip Dysplasia (DDH) are often categorized~     depending on the severity of their hip malformation. Regardless of the severity, the accepted~     form of treatment is the Pavlik Harness. Unfortunately, there is no specific recommended~     treatment regarding length of Pavlik Harness treatment for patients with DDH who have who~     have been categorized with stable Graf type IIc hips. The investigators will aim to answer~     this question with a randomized controlled trial of patients with these specific findings by~     dividing selected patients into 2 arms. Each arm consists of varying lengths of Pavlik~     harness treatment (6 weeks full-time or 12 weeks full-time). Patient's two year follow up~     radiographs will determine the best means of treatment.~   "
22251|NCT03275792|"~     This study will provide feasibility data regarding the conduct of a clinical trail evaluating~     the use of early aggressive inpatient intravenous rehydration in children with Shiga Toxin~     producing E. coli infection.~   "
22252|NCT03275779|"~     This study will investigate whether manipulating resistance exercise frequency impacts muscle~     protein synthesis rates. The investigators will test the hypothesise that a higher resistance~     exercise frequency will result in greater muscle protein synthesis rates than a lower~     resistance exercise frequency.~   "
22253|NCT03275766|"~     Psychomotor slowing may occur in major psychiatric disorders, such as major depressive~     disorders or schizophrenia spectrum disorders. It refers to slowing of fine motor skills,~     motor planning and gross motor behavior. In major depression and schizophrenia, psychomotor~     slowing is associated with alterations of premotor cortex, dorsolateral prefrontal cortex and~     basal ganglia. This randomized, sham-controlled, prospective trial will test, whether 15~     sessions of repetitive transcranial magnetic stimulation (rTMS) may ameliorate psychomotor~     slowing in schizophrenia or major depression.~   "
22254|NCT03275753|"~     The goal of this study is to assess a battery of visual function tests in subjects with~     non-exudative age-related macular degeneration~   "
22255|NCT03275740|"~     This phase 1 single ascending dose study will provide a first in human assessment of safety~     and tolerability of PF-06755347 in healthy adult subjects. The pharmacokinetics and~     pharmacodynamics will also be evaluated.~   "
22256|NCT03275727|"~     Background: Internet-delivered interventions (IDI) can provide remarkable opportunities in~     addressing breast cancer (BC) survivors' unmet needs, as they present an effective strategy~     to improve care coordination and provide access to efficacious, cost-efficient and convenient~     survivorship care. Nevertheless, research focusing on this field and aiming at improving~     survivors´ psychosocial needs is scarce and its practical implementation is limited.~      Objectives: This study aims at studying BC patients´ and healthcare providers' attitudes~     towards IDI; exploring BC patients´ unmet support needs and; determining the acceptability,~     feasibility, efficacy and cost-effectiveness of iACT-BC, a guided internet-delivered~     individually-tailored ACT-influenced cognitive behavioural intervention designed to improve~     psychosocial outcomes in BC survivors when compared to treatment as usual. The primary~     outcomes in this research are anxiety and depression. Secondary outcomes include~     psychological flexibility, fatigue, insomnia, Sexual dysfunction (SD) and Health Related~     Quality of Life.~      Methods: A multimethod research design will be applied and two consecutive studies will be~     performed. Study 1 will explore participants´ attitudes towards IDI as well as, BC patients'~     psychosocial unmet needs by adopting an exploratory cross-sectional study design. Study 2~     will investigate the effectiveness and cost-effectiveness of iACT-BC in BC survivors, by~     implementing a two-arm, parallel, open label, multicentre, waiting list randomized controlled~     trial.~      Expected Results: It is anticipated that iACT-BC will show to be an effective and~     cost-effective program in improving anxiety, depression, psychological flexibility, fatigue,~     insomnia, SD and HRQoL in BC survivors, as opposing to a waiting list control under treatment~     as usual. The results of this research will be published in accordance with CONSORT 2010 and~     CONSORT-EHEALTH guidelines and should be available for publication in February 2020.~   "
22257|NCT03275714|"~     The primary objective of the clinical trial is to evaluate the data of an app for smartphones~     (BiP-App) with regard to sleep, movement, mood and communication behavior.~      The data will be compared between two groups: people with a bipolar affective disorder and~     individuals without a psychiatric disorder.~      Secondary objective of the trial is to investigate if it is possible to detect early warning~     symptoms of depressive / (hypo) manic episodes via the measured behavior patterns.~      Furthermore it will be evaluated whether the BiP-app can find applicability in the examined~     patient group.~      Study design: Clinical evaluation of a medical device without CE mark; Parallel study design~   "
22258|NCT03275701|"~     Phase IV, Single-Arm, Open-Label Study Evaluating Bone Mineral Density in HIV-1-Infected~     Adults ≥50 Years Old Switching from EVG/COBI/FTC/TAF (Genvoya) or EVG/COBI/FTC/TDF (Stribild)~     to ABC/DTG/3TC (Triumeq)~   "
22259|NCT03275688|"~     This study will evaluate exhaled volatile organic compounds (VOC's) in the breath of~     participants with stage 1 lung cancer, their house-mates, and matched controls. The goal of~     the study is to identify VOC fingerprints that are only detectable in those with stage 1 lung~     cancer.~   "
22275|NCT03275467|"~     Microscopic colitis (MC) is a disease with chronic inflammation of the colon that is mostly~     diagnosed in middle-aged or elderly women. Patients suffer from chronic watery diarrhoea,~     abdominal pain and weight loss. The aetiology of MC is still unknown but it is hypothesized~     that MC is caused by a deregulated immune response to a luminal agent in predisposed~     individuals, and an important role of the intestinal microbiota is suggested.~      In the current proof-of-concept study, the effect of faecal microbiota transfer (FMT) in 10~     MC patients will be evaluated. FMT consists in the infusion of suspended stool from a healthy~     donor into the intestine of a patient with the aim to restore a disturbed intestinal~     microbiota.~   "
22260|NCT03275675|"~     The pharmacist, as a specialist of medications, occupies a strategic position: he~     participates in a global care of their patients. Dispensation is the pharmaceutical act which~     associates with the dispensing of medications the pharmaceutical analysis of the medical~     prescription if it exists, the possible preparation of the doses to be administered and the~     provisions of the information and advices necessary for the proper use of medications. The~     pharmacist ensures that the quality and safety of the dispensation is guaranteed at all times~     by limiting as far as possible the risks associated with an error in delivery, prescription,~     drug interactions or undetected contraindications, inadequate dosages or non-compliance with~     treatment. The longer the patient feels satisfied with the stage of delivery of his~     treatment, the better his adherence to treatment is, and the less he will encounter poor~     compliance. Oncology has particularly benefited in recent years from the introduction of~     numerous drugs with the aim of extending the duration of response in a growing number of~     indications. Traditionally in oncology, chemotherapy treatments are administered~     intravenously by trained personnel and rarely managed by the patient at home. Recently, there~     has been a growing choice of oral formulations, whether for conventional hormonal, anticancer~     therapies or targeted therapies. These specialties are now widely available in community~     pharmacies. Oral administration puts the patient at the center of his therapeutic management.~     He must take his medication alone. Adherence and compliance are therefore particularly~     important here for an optimal risk-benefit ratio. This study project is designed to evaluate~     the satisfaction of patients undergoing oral chemotherapy treated for a cancer pathology and~     whose treatment is provided by their community pharmacies. It also needs to provide~     information about the reasons for their poor adherence to treatment (personal factors,~     factors attributable to treatment, factors attributable to the care system). Patients will be~     recruited and interviewed by contacting several departments of the Clermont-Ferrand~     University Hospital (CHU de Clermont-Ferrand), who are used to caring for patients with~     cancerous diseases (hematology, urology, respiratory, gastro-enterology). The data collected~     in this study may be used for subsequent studies evaluating new management strategies or~     therapeutic education to improve adherence to patient treatment.~   "
22261|NCT03275662|"~     The primary objective is to contrast the degree to which increased consumption of dietary~     fiber vs. probiotics can increase microbiota diversity and can impact microbiota production~     of short-chain fatty acids (SCFA), potential normalizers of metabolic and immune dysfunction,~     in obese and non-obese adults.~   "
22262|NCT03275649|"~     Non-motor symptoms (NMS) are common in Parkinson's disease (PD) and cause significant~     distress and decreased quality of life. A high rate of non-declaration of NMS by patients~     means that many NMS remain unrecognized and untreated, even in specialist clinical services.~     In phase one of this research qualitative interviews (phase 1) were guided by the Theoretical~     Domains Framework and used to identify the barriers for help-seeking. A quantitative~     questionnaire survey (phase 2) examined the significance of these barriers to help seeking.~     The present study aims to develop (phase 3) and test the feasibility (phase 4) of a targeted~     behavioural intervention of barriers which were identified in phases 1 and 2 which prevent~     help-seeking for NMS in patients with PD. As with phases 1 and 2, the feasibility trial will~     include people with unreported burdensome NMS, who have not reported them to their PD~     consultant or nurse. The intervention has been co-designed by people affected by Parkinson's~     and targets the barriers identified in the previous phases of the research. In phase three of~     the research, 'think-aloud' interviews will be used to further develop the intervention so~     that it is acceptable and easy to use. In the final phase, a feasibility trial will be~     conducted to examine efficacy of the intervention for increasing help-seeking for undeclared~     NMS. The study has implications for using a theoretically driven behavioural intervention to~     promote help-seeking for NMS and ultimately increase receipt of clinical care for NMS among~     patients with PD.~   "
22263|NCT03275636|"~     The goal of this trial is to compare the outcome after partially matched (single mismatch)~     unrelated donor transplantation with haploidentical transplantation in a randomized~     controlled setting.~   "
22264|NCT03275623|"~     The purpose of the study is to determine if treatment of pregnant women with urine cultures~     with a low level of bacteria (less than 100,000 colony forming units (CFU)) may decrease~     adverse pregnancy outcomes.~   "
22265|NCT03275610|"~     This study seeks to uncover potential genetic determinants of pulmonary embolism (PE). Our~     translational goal is to ultimately identify certain genetic markers that will allow us to~     stratify patients in terms of their PE risk post total knee or total hip arthroplasty. The~     clinical implications for this study would allow for better patient care by lowering the risk~     of post-operative bleeding while still preventing symptomatic PEs and deep vein thromboses~     (DVTs). We look to sample patients who have a history of PE after undergoing total knee or~     total hip arthroplasty. We will sample these patients' blood DNA for a set of DNA genetic~     markers. To do so, we will utilize the Taqman assay, which is a PCR-based 5'-nuclease allelic~     discrimination assay to determine single nucleotide polymorphism (SNP) genotypes at specified~     loci. The region flanking the SNP is amplified using two allele-specific fluorescent probes,~     allowing for the detection of each allele in a single tube. Using this assay, there is no~     post-PCR processing because the probes are included in the PCR reaction (Hui). Using this~     approach, we will measure the frequency of genetic mutations in patients who have developed a~     PE after a total joint arthroplasty. This data would then be used to perform a prospective~     study to determine a subset of genetic markers that can definitively be used to risk stratify~     patients.~   "
22266|NCT03275597|"~     This is a phase Ib study to evaluate safety and tolerability of dual checkpoint inhibition~     (DCI) of durvalumab (anti-PD-L1) and tremelimumab (anti-CTLA-4) with SBRT in the treatment of~     oligometastatic NSCLC. This study will examine the sequential delivery of SBRT to all disease~     sites followed by combination of durvalumab and tremelimumab for patients for whom the goal~     is ablating all known sites of disease. We anticipate that for many patients this will be the~     first line-therapy. Patients who have received prior-platinum-based chemotherapy and/or any~     line of prior chemotherapy are eligible. Prior immunotherapy treatment is not allowed.~   "
22276|NCT03275454|"~     The purpose of this study is to explore the safety, preliminary clinical benefit, and~     activity of TNT009 in patients with chronic immune thrombocytopenia.~   "
22277|NCT03275441|"~     The study evaluates whether an eye test called an electroretinogram (ERG) can be shortened~     and still produce the same diagnostic results. The results of this study may allow test times~     to be reduced which will have benefits such as improved patient compliance during shorter~     testing and increased clinic efficiency.~   "
22301|NCT03275129|"~     The investigators would like to investigate whether performing ultrasound assessments in~     patients undergoing surgery for hip fractures is able to identify previously undiagnosed~     heart or lung conditions. The investigators would like to determine whether information~     provided by this ultrasound assessment is significant enough to alter the anesthetic~     management plan of these patients. This study has the potential to demonstrate that~     ultrasound could be used as a diagnostic bedside tool in the perioperative period, possibly~     altering standard of care for this patient population.~   "
22267|NCT03275584|"~     Positron emission tomography (PET) myocardial perfusion imaging (MPI) is an examination that~     helps to assess the function and perfusion of the heart. Completion of this examination~     requires the injection of a small dose of a radiotracer (a radioactive substance).~      PET MPI is a state-of-the-art non-invasive cardiac imaging tool. The main goal of the PET MPI~     examination is to assess if one or more of the arteries feeding blood to your heart are~     blocked. This examination replaces an older technology (single photon emission computed~     tomography, or SPECT), and allows the obtention of more accurate information, and new~     information that the older SPECT technology did not assess. The radiation dose received as~     part of the procedure is also smaller with PET versus SPECT.~      One of the substances which can be used for PET MPI is called N-13 ammoniac (NH3). For this~     clinical study, NH3 which will be produced at the Centre de Recherche du Centre Hospitalier~     de l'Université de Montréal (CRCHUM), per the standards and methods prescribed by Health~     Canada. NH3 is not currently approved for clinical use by Health Canada. It is thus~     considered and experimental substance in the context of this study.~      Participants will undergo PET MPI with the CRCHUM NH3. The PET MPI procedure itself is not an~     experimental procedure and is not part of the research protocol. Only the use of NH3 produced~     at the CRCHUM is experimental.~      The main objective of this research study is to validate the production process and assess~     the safety of the NH3 produced at the CRCHUM cyclotron. Secondary objectives include the~     assessment of prescription practices amongst physicians who refer patients for PET MPI, and~     how they will change over time.~   "
22268|NCT03275571|"~     Among people with HIV, the severity of depressive symptoms has repeatedly been associated~     with the presence of self-reported cognitive difficulties, even in the absence of impairment~     on neuropsychological testing. There is uncertainty about the clinical importance of these~     self-reports, especially when neuropsychological testing is normal.~      However, there is growing evidence that these self-reports are clinically important. For~     example, among patients with major depressive disorder (MDD), evidence suggests that~     functional impairments is mediated by self-reported cognitive dysfunction, rather than~     objective cognitive dysfunction. Treatment of depression with Cognitive-Behaviour Therapy~     (CBT) has been shown to improve depressive symptoms and psychosocial functioning in patients~     with recurrent major depressive disorder, but there are few studies of the impact of~     psychotherapy on self-reported cognition and cognitive performance. Good Days Ahead (GDA) is~     a computerized treatment program developed to address symptoms of depression and anxiety. It~     teaches the basic principles of computerized behavioral therapy (CBT) in nine therapy~     sessions, each typically taking 30 minutes to complete. GDA has been found to be as effective~     as face-to-face CBT in decreasing symptoms of depression and anxiety.~      The hypothesis is that people whose depressive symptoms are reduced following treatment with~     cCBT will also report fewer cognitive difficulties than before treatment. A second hypothesis~     is that changes in self-reported cognition will be concordant with changes in cognitive~     performance, such that people who make no improvement in self-report cognition will also show~     no improvement in cognitive performance and those who do improve on self-report will improve~     on cognitive performance.~   "
22269|NCT03275558|"~     This is a study to determine the efficacy, safety and clinical benefit (how well the drugs~     works), of the pharmaceutical compositions in Nasal Spray NST-4G for the treatment of brain~     tumors( Recurrent Glioblastoma, Gliosarcoma,Anaplastic Gliomas, Previously Treated).~      All drugs target the inhibition of the growth factors and neo-angiogenesis as one the main~     reasons for the growth of the tumor.~      The purpose of the Nasal Spray NST-4G study is to determine the safety and tolerability in~     order to establish the best dose level to be used in future studies.~   "
22270|NCT03275545|"~     The objective of this study is to identify the patterns of brain activity in reward circuitry~     that promote symptoms of anorexia nervosa. This project will compare weight-restored~     individuals with anorexia nervosa to a non-eating disorder control group on reward brain~     circuitry patterns in response to typically rewarding cues (i.e., entertaining videos) and~     disorder-specific restrictive eating cues (i.e., low-fat food choice) using fMRI. In~     addition, this study will examine which neurobiological reward responses among~     weight-restored individuals with anorexia nervosa predict objective restrictive eating~     (measured by laboratory meal intake) and longitudinal risk of relapse one year later.~   "
22271|NCT03275519|"~     Hypospadias is a common condition where the opening of the penis is not located at the tip,~     but along the underside of the penis. It is estimated to occur in 1/300 live male births,~     making it one of the most common birth defects. Degrees of hypospadias ranged from minor to~     severe depending on the location of the opening. Surgical repair is often required and~     involves placement of a catheter for the urine to drain with known urinary colonization found~     on prior retrospective studies. The current practice of using preventative antibiotics as~     long as the catheter is in place is conflicting with resent studies that show antibiotics may~     not be necessary to prevent urinary tract infections (UTIs).~      The purpose of this study was to see how common symptomatic UTIs were after hypospadias~     repair surgery; and to see whether routine antibiotic use after surgery affected the rate of~     UTIs. Subjects were randomized to either receive antibiotics or no antibiotics after distal~     hypospadias repair. The research coordinator made follow-up phone calls with the family and~     the primary care provider (PCP) after stent removal, 30 days post surgery and after the 3~     month post surgical visit.~   "
22272|NCT03275506|"~     There are several data suggesting that pembrolizumab and bevacizumab may be synergistic.~     Enhanced tumor angiogenesis is commonly associated with absence of tumor-infiltrating T cells~     in patients. There is evidence in OC that tumor expression of VEGF is negatively correlated~     to the density of CD3+TILs and this phenotype is associated with early recurrence, consistent~     with prior studies showing a correlation of VEGF to early recurrence and short survival.~     Furthermore, in ascites, high levels of VEGF correlate to low numbers of NK T-like CD3+CD56+~     cells~      This randomized phase II study aims to evaluate the efficacy of pembrolizumab in combina-tion~     with the standard neo adjuvant chemotherapy followed by IDS and the safety of this strategy~     in patients with advanced ovarian cancer. We assume that its administration in the neo~     adjuvant setting combination with standard of care (4 cycles of standard chemotherapy) would~     improve the response rate and consequently will help to achieve optimal debulking rate at~     IDS.~      After surgery, patients will continue to be treated with standard of care (chemotherapy for 2~     to 5 cycles plus or less bevacizumab) or the same combination plus pembrolizumab (keytruda).~   "
22278|NCT03275428|"~     Video assisted thoracic surgery utilizes small instruments to perform complicated thoracic~     surgeries. This minimally invasive technique leaves small wounds thus facilitate recovery.~     Traditionally, thoracic surgery required general anesthesia with double lumen endobronchial~     tube to facilitate one-lung ventilation. However, as anesthesia techniques improve, video~     assisted thoracic surgery can be achieved with minimal sedation and without intubation.~     Thoracic surgeries involve excision of lung tissue thus impair post-operative lung function,~     putting patients at high risk of cardiopulmonary complications. Non-intubate thoracic~     surgeries can avoid this complication by avoiding general anesthesia and intubation.~      Transnasal humidified rapid-insufflation ventilator exchange offers 30-50 L/min oxygen via~     nasal cannula, thus provide safe and comfortable way of oxygen supplementation. It is useful~     in intravenous sedated patients since they are prone to hypoxia from respiratory suppression~     and upper airway obstruction.~      This study is a matched case-control study to compare the efficacy and safety of Transnasal~     humidified rapid-insufflation ventilator exchange in non-intubated thoracic surgery versus~     double lumen endobronchial tube intubated general anesthesia.~   "
22279|NCT03275415|"~     A double-blind study includes: 1) birth Wt 500-1499 gm, 2) respiratory distress shortly after~     birth and requires resuscitation 3) failure to NCPAP within 4 hrs after birth, defined as: a)~     FIO2 ≥ 0.30, pressure > 5cmH2O b) severe retraction c) apnea d) PCO2 ≥ 60 mmHg. Exclusion~     criteria: 1) lethal cardiopulmonary status 2) severe congenital anomalies. Sample size will~     be determined based on a one-third (33%) improvement of the current incidence of BPD or death~     in the selected population (from 50%→33%), allowing a type I error 0.05, type II error 0.10~     (power 0.90), 182 infants in each group would be needed and 190 in each group would be a safe~     target number. The infants will be randomly assigned to control (C) (Curosurf/placebo) or~     intervention (I) (Curosurf/budesonide); given q. 12 hrs for a maximum of 3 doses unless the~     infant is extubated or require FIO2 <30%. Appropriate amount of placebo will be used as it~     does not affect the biophysical property of curosurf (PAS abstract 2017 San Francisco)~     Primary outcome of study is death or BPD defined by NICHD criteria. Follow up study of~     neuromotor and cognitive function and pulmonary states will be done at 1-2 years of corrected~     age.~   "
22280|NCT03275402|"~     Children with a neuroblastoma diagnose and central nervous system (CNS)/leptomeningeal~     metastases will be given up to 2 rounds of intracerebroventricular treatment with a~     radiolabelled monoclonal antibody, 131I-burtomab to evaluate efficacy and safety~   "
22281|NCT03275389|"~     The purpose of this study is to assess the reactogenicity, safety and immunogenicity of~     different formulations of GlaxoSmithKline (GSK) Biologicals' investigational supra-seasonal~     universal influenza vaccines (SUIVs) (unadjuvanted or adjuvanted) in 18 to 39 year-old~     healthy subjects. Subjects will be enrolled and vaccinated with one or 2 primary dose(s)~     followed by a booster dose one year later.~   "
22282|NCT03275376|"~     Background:~      Hepatocellular carcinoma (HCC) is the second leading cause of cancer death worldwide,~     including the condition in Taiwan, and the management of HCC is an important challenge in~     public health. Target therapy with sorafenib is the standard of treatment for advanced HCC~     (vascular invasion or extrahepatic metastasis), but the patient survival time is still~     unsatisfactory. In recent years, growing evidences, including mechanism analysis, have~     suggested the anitneoplastic effects of statin, and a recent pooled analysis found that~     statin use may be associated with improved survival in patients with metastatic rencal cell~     carcinoma. However, a prospective clinical trial of statin sorafenib combination therapy in~     the treatment of advanced HCC is lacking.~      Aims:~        1. To prove statins improve the overall survival for patients who receive sorafenib therapy~          for advanced HCC by a prospective randomized controlled study.~        2. To prove statin can improve tumor responses and the progression free survival for~          patients who receive sorafenib therapy for advanced HCC by a prospective randomized~          controlled study.~      Methods:~      This randomized placebo-controlled study will prospectively enroll patients who receiving~     sorafenib therapy for advanced HCC in the Taichung Veterans General Hospital, and statin or~     placebo will be statin or placebo will be administered according to randomized allocations.~     Tumor responses, time to tumor progression, and survival time will be followed and recorded~   "
22283|NCT03275363|"~     The HKU Neurocognitive Disorder (NCD) Cohort is a hospital-based, prospective, observational~     study of older HK Chinese adults with cognitive impairment, with a special focus on studying~     patients with subjective cognitive decline and mild cognitive impairment.~   "
22284|NCT03275350|"~     The Primary Objective of this study is to compare the effectiveness of HIV clinic-based~     extended-release Naltrexone (XR-NTX) in decreasing substance use and increasing HIV viral~     suppression in HIV-infected participants with opioid use disorder to Treatment as Usual in~     this population.~   "
22285|NCT03275337|"~     Emerging neuroimaging studies have shown that the cerebellum contributes to different aspects~     of timing, prediction, learning, and extinction of conditioned responses to aversive stimuli,~     factors that may be relevant to the success of exposure based behavioral therapy. Our goals~     are to determine the cerebellar contributions to fear extinction by attempting to modulate~     key pathways in this process by theta burst stimulation. The long term goal is to lay the~     foundation for future studies in which neuromodulation is used to augment exposure therapy.~   "
22286|NCT03275324|"~     The Capnostream 20p monitor by Medtronic is FDA-cleared and consists of a monitor which~     measures real-time respiratory status based on respiratory rate, pulse rate, pulse oximetry~     (SpO2) and end tidal carbon dioxide (etCO2) with a disposable nasal canula.~      The integrated pulmonary index (IPI) is an algorithm driven parameter derived from~     non-invasive etCO2, respiratory rate, pulse rate and SpO2. Fuzzy logic is used to produce a~     value from 1-10 with 4 and under requiring intervention and 8-10 representing the normal~     range.~      The purpose of this observational study is to determine if the IPI is associated with~     complications in the immediate postoperative period.~      The study will enroll approximately 600 patients at 2 centers. Clinicians will be blinded to~     the IPI therefore this device will not be used to guide care in any way.~   "
22287|NCT03275311|"~     The Epidemio-Strategy and Medical Economic (ESME) OVR Data Platform is a multi-center real~     life database using a retrospective data collection process (18 FCCCs over 20 sites). This~     database compiles data from Patient's Electronic medical records (EMR), inpatient~     Hospitalisation records and Pharmacy records.~   "
22289|NCT03275285|"~     Primary Objective:~      To demonstrate the benefit of isatuximab in combination with carfilzomib and dexamethasone in~     the prolongation of Progression Free Survival (PFS) as compared to carfilzomib and~     dexamethasone in patients with relapsed and/or refractory multiple myeloma (MM) previously~     treated with 1 to 3 lines of therapy.~      Secondary Objectives:~        -  To evaluate the Overall Response Rate (ORR), rate of very good partial response (VGPR)~          or better and complete response (CR) rate in both arms using International Myeloma~          Working Group (IMWG) criteria.~        -  To evaluate rate of VGPR or better with minimal residual disease (MRD) negativity in~          both arms using IMWG criteria.~        -  To evaluate the Overall Survival (OS) in both arms.~        -  To evaluate safety in both arms.~        -  To evaluate duration of response (DOR) in both arms.~        -  To evaluate the Time To Progression (TTP) in both arms.~        -  To evaluate the Second Progression Free Survival (PFS2) in both arms.~        -  To determine the Pharmacokinetic profile of isatuximab in combination with carfilzomib.~        -  To evaluate the immunogenicity of isatuximab in isatuximab arm.~        -  To assess disease-specific and generic health-related quality of life (HRQL), disease~          and treatment-related symptoms, health state utility, and health status in both arms.~   "
22290|NCT03275272|"~     IGF-I is a mitogenic and antiapoptotic. paracrine growth factor expressed in all fetal organ.~     and is essential in fetal and neonatal growth, differentiation and development Several lines~     of evidence suggest that IGF-I levels are associated with birth weight -furthermore higher~     IGF-I levels are associated with higher BW, but not with lower birth weight]. In adulthood,~     elevated concentrations of IGF-I are associated with an increased risk of obesity and many~     cancers, including breast, lung, head and neck, colorectal, pancreas, synovial sarcoma, and~     prostate canc. Although concentrations of circulating IGF-I levels vary considerably by~     race/ethnicity and maternal pre-pregnancy obesity, few studies included African American~     women an ethnic group that has an almost 9% higher BMI than European-American women~   "
22291|NCT03275259|"~     PURPOSE: To evaluate the efficacy of shock waves extracorporea in improving body~     contour,decrease fat localized and appearance of gynoid lipodystrophy.~      SUBJECTS AND METHODS: A prospective and comparative longitudinal clinical study will be~     performed in 30 women with localized fat and gynoid lipodystrophy. Patients will be submitted~     data collection and assessments and before and after treatment.~      HYPOTHESES: It is expected that the patients will present improvement in the body contour,~     decrease fat localized and in the picture of the gynoid lipodystrophy after of the therapies.~      STATISTICAL ANALYSIS: A descriptive analysis will be done before and after~     vibration-oscillatory therapy, with frequency tables for categorical and descriptive~     variables (mean, standard deviation, median, minimum and maximum values) for continuous or~     numerical variables. In order to compare the main variables between the groups and the~     collection times, the analysis of variance (ANOVA) for repeated measurements will be used.~     Tukey's test will be used to compare groups. The level of significance adopted for the~     statistical tests will be 5% or p <0.05.~   "
22292|NCT03275246|"~     The goal of this study is to establish the accuracy of the new X-PSI Knee System guides by~     analyzing early postoperative (4-6 weeks) imaging data with regards to the mechanical~     alignment and compare them with preoperative planning imaging data. Mechanical alignment in~     the hip-knee-ankle (HKA) frontal plane with X-PSI Knee System will be measured and compared~     with results reported in the literature using a conventional (non-guided) approach.~      Hypothesis: The use of the new X-PSI Knee System achieves the same accuracy with respect to~     mechanical alignment as with conventional instrumentation.~   "
22293|NCT03275233|"~     Psychiatric comorbidities in patient with Painful Peripheral neuropathy~   "
22294|NCT03275220|"~     Assessment Of Right Ventricular Function In Patients Undergoing Coronary Artery Bypass Graft~     In Assiut University~   "
22295|NCT03275207|"~     Chronic postoperative pain (CPSP) is common symptom in patients after surgery, seriously~     affected the quality of life. Accumulating evidences have demonstrated dexmedetomidine can~     improve chronic pain. However, the prevention of dexmedetomidine on CPSP remain uncertain.~   "
22296|NCT03275194|"~     Ovarian cancer is the leading cause of gynecological cancer mortality, with no current~     screening method effective for early diagnosis, with 75% of advanced stage patients being~     detected. Not all patients are candidates for standard treatment, which is primary~     cytoreduction followed by adjuvant chemotherapy, due to the advanced process. A subgroup of~     patients will receive neoadjuvant chemotherapy followed by interval surgery, which allows~     higher rates of optimal cytoreduction with low morbidity and mortality. Hyperthermic~     intraperitoneal chemotherapy (HIPEC) is a therapeutic option that is used in pathologies of~     peritoneal dissemination, whose morbidity and mortality has been reported in several series~     and is promising as a management option for ovarian cancer, so it is necessary to evaluate~     morbidity and mortality that conditions this modality of treatment as well as if it impacts~     on the quality of life of the patients to whom they are performed, which will allow offering~     our patients an option of additional treatment to the standard.~   "
22297|NCT03275181|"~     The aim of this project is to determine whether androgen deprivation therapy (ADT) decreases~     left ventricular function in prostate cancer patients. If found successful, this may lead to~     improved cardiovascular health via treatment and/or lifestyle interventions in prostate~     cancer populations.~   "
22298|NCT03275168|"~     This pilot project will evaluate the feasibility, acceptability, and preliminary~     effectiveness of a couples-based behavioral intervention [COUPLES] that augments individual~     evidence-based interventions with joint health education counseling for STI-affected AYA~     dyads within a primary care setting.~   "
22299|NCT03275155|"~     This prospective non-interventional cohort study investigates the pathophysiology of Atrial~     Fibrillation Detected After Stroke or transient ischemic attack (AFDAS) by comparing the~     autonomic function and inflammation between patients with AFDAS, patients with atrial~     fibrillation (AF) diagnosed before the ischemic event or known AF (KAF), and patients with~     normal sinus rhythm (NSR) after 14 day of cardiac monitoring following the event onset.~   "
22300|NCT03275142|"~     To demonstrate that the Icare tonometer does not alter Keratometry readings, topography, or~     corneal staining. This would therefore allow intraocular pressure (IOP) testing to be done at~     any time during an exam, without affecting other testing. This may improve office-flow and~     spare patients from returning for another exam for additional testing.~   "
22304|NCT03275090|"~     Introduction and objectives: Lipid emulsions play an important role in parenteral nutrition~     in preterm infants. We aim to evaluate the effect of two different intravenous lipid~     emulsions on the outcomes of neonatal sepsis in preterm infants.~      Methods: A randomized controlled trial is conducted in the Neonatal Care Unit of Mansoura~     University Children's Hospital, Egypt. Forty preterm infants with clinically suspected sepsis~     are enrolled and assigned randomly into one of two groups, one receive MOFS lipid emulsion~     (MOFS group) and the other receive pure soyabean oil-based emulsion (S group). Clinical and~     epidemiological data are collected. Assessment is done on 1st day and 7th day post~     randomization including growth parameters, complete blood count, C-reactive protein, random~     blood glucose, serum creatinine, serum triglyceride, soluble intercellular adhesion molecule~     1 (sICAM-1) and leukocyte integrin β2. Between-groups and within-group differences will be~     analyzed statistically.~   "
22305|NCT03275077|"~     Background: Coagulopathy in chronic kidney disease is multifactorial. Both hypocoaguability~     and hypercoaguability are seen. Conventional tests of coagulation (CCTs) end at the formation~     of thrombin, and do not take into account the interaction of coagulation factors, platelets,~     RBC etc. By overcoming the above deficiencies, thromboelastography provides a holistic~     picture of blood coagulation. The present study evaluated the TEG profile of ESRD patients~     and compared it to CCTs and to controls.~      Methods: 50 ESRD patients and 50 controls were recruited for the study. Venous samples were~     withdrawn and platelet count, INR and fibrinogen levels were measured. Simultaneously a~     Thromboelastography was performed. All samples were drawn prior to initiation of dialysis.~   "
22306|NCT03275064|"~     The purpose of this study is to assess the efficacy, safety and tolerability of multiple~     intra-articular (i.a.) injections of LNA043 over 4-weeks, in regenerating the articular~     surface in patients with cartilage lesions of the knee.~   "
22307|NCT03275051|"~     GSK2696277 is a gene therapy drug product consisting of autologous hematopoietic~     stem/progenitor cluster of differentiation (CD) 34+ cells genetically modified with a~     lentiviral vector (GLOBE) encoding the human beta globin gene. The TIGET-BTHAL is a phase~     I/II study evaluating safety and efficacy of GSK2696277 in subjects with transfusion~     dependent beta-thalassemia for two years post gene-therapy. Subjects who have undergone gene~     therapy are at risk of delayed adverse events. Thus, this study is designed as a longer term~     safety and efficacy follow-up of TIGET-BTHAL for a further six years (i.e. until eight years~     post-gene therapy) in subjects who previously completed the TIGET-BTHAL study. Approximately~     10 subjects who have received treatment with GSK2696277 in and completed study TIGET-BTHAL~     will be included in this study. The entire post-gene therapy follow-up will be of eight years~     i.e. two years in TIGET-BTHAL plus six years in this study.~   "
22308|NCT03275038|"~     In this three-year project, investigators will target on sedentary middle-aged and older~     adults with cardiovascular risks, prescribe 24-week Tai Chi or aerobic exercises and examine:~        1. Whether both exercises are effective to reduce cardiovascular risks, prevent~          leukoaraiosis and associated declines in physical and psychological functions at Week 12~          and 24;~        2. Will Tai Chi exercises be more effective on improving psychological health (cognition,~          psychological well-being, and exercise self-efficacy) than aerobic exercises at Week 12~          and 24? If yes, are these effects mediated by specific brain structural and functional~          mechanisms?~        3. Will aerobic exercises be more effective on improving physical health (motor functions,~          physical fitness, and heart rate variability) than Tai Chi exercises at Week 12 and 24?~          If yes, are these effects mediated by other specific brain structural and functional~          mechanisms?~        4. After 12 and 24 weeks of Tai Chi and aerobic exercises, what are the relationships~          between reduction of cardiovascular risks and changes in brain structure and functions?~      An assessor-blind randomized controlled clinical trial will be used. Based on known effect~     size of Tai Chi exercises on cognitive function (please refer to CM03, pages 9-10), 120~     sedentary middle-aged and older adults with cardiovascular risks will be recruited and~     randomly assigned to the Tai Chi, Aerobic, or Control (usual care) group. The Tai Chi and~     Aerobic groups will receive three one-hour exercise sessions weekly for 24 weeks, supervised~     for the first 12 weeks and unsupervised for the next 12 weeks. The Control group will~     maintain the original life style. Clinical measures of cardiovascular risks and blood~     markers, brain structures and functional images, psychological (cognitive, psychological~     well-being and exercise self-efficacy) and physical (motor functions, physical fitness, and~     heart rate variability) functions will be collected at baseline, Week 12, and Week 24 to~     compare differences among the three groups across the three time points. Investigators will~     also examine the interrelationships of changes in brain structural and functional~     organization with changes in other measures, in an effort to understand the neural mechanisms~     of exercise effects.~   "
22309|NCT03275025|"~     This is a multicenter, randomized, double-blind phase2 study to evaluate the safety and~     investigate the efficacy of YRA-1909 in Patients with Rheumatoid Arthritis who are on a~     stable dose of Methotrexate(MTX) and who have an inadequate response to MTX(MTX-IR).~   "
22310|NCT03275012|"~     The objective of the study is to evaluate the efficacy of gabapentin as adjunctive therapy to~     morphine in the treatment of severe chronic neuropathic or mixed pain in children from 3~     months to less than 18 years of age assessed by the difference in average pain scores between~     treatment arms at the end of the treatment period.~   "
22311|NCT03274999|"~     This study will evaluate the change in tear meniscus height (TMH) produced by intranasal~     stimulation with TrueTear compared with the same device applied extranasally (control).~   "
22312|NCT03274973|"~     Assessment of long-term effectiveness of ZOMACTON in treatment of Growth Hormone Deficiency~     or growth retardation due to Ullrich-Turner Syndrome and assessment of compliance and~     adherence, optionally with the aid of an electronic app or patient diary.~   "
22313|NCT03274960|"~     This study is evaluating whether screening of a pregnant woman for asymptomatic bacteriuria~     in each trimester for early detection and treatment of bacteriuria will reduce the incidence~     of preterm birth in Harare.~   "
22314|NCT03274947|"~     The study is designed to explore the effectiveness of non-invasive cerebellar stimulation to~     enhance motor plasticity in the cortex after stroke. The investigators have shown that the~     human cerebellum is strongly activated during the act of swallowing and when stimulated with~     single TMS pulses can strongly facilitate the corticobulbar projection to the pharynx in~     humans. More recently the investigators have identified the most relevant frequency of~     stimulation of the cerebellum that can produce longer term excitation in the human swallowing~     motor system. The investigators therefore believe that the potential for cerebellar~     stimulation in improving swallowing is much greater than other methods for two reasons.~     Firstly, previous work has shown that unlike successful recovery of hand/arm function which~     relies on restoring activity in the stroke hemisphere, recovery of swallowing function relies~     on increased excitability in intact projections from the non-stroke hemisphere. The~     investigators believe that methods that can enhance these undamaged pathways have a greater~     chance of inducing recovery in the human swallowing system in unilateral stroke. Additionally~     cerebellar stimulation produces very high levels of corticobulbar excitation it may also have~     the advantage of improving dysphagia in posterior fossa strokes. Second, the human cerebellum~     is relatively easy to target and stimulate and has reduced risk of inducing unwanted effects~     (such as seizures) which as a consequence makes cerebellar stimulation a more pragmatic~     method for delivering therapeutic neurorehabilitation to dysphagic stroke patients compared~     to other more complex/riskier methods.~      A final factor is that the investigators have developed a virtual lesion model of~     swallowing dysfunction in healthy volunteers which can be reversed quite successfully with~     other neuro-stimulation protocols. The investigators can therefore use this model to test the~     effectiveness of cerebellar stimulation protocols (ipsilateral and contralateral cerebellar~     sites) before choosing the most effective side to apply stimulation in a proof of principle~     trial/study in a small group of sub-acute dysphagic patients.~      The hypotheses are that cerebellar TMS will:~      i. Reverse the brain inhibition and behavioural dysfunction following a virtual lesion model~     of disrupted swallowing in healthy brain (phase 1); ii. Reduce the degree of aspiration in~     acute dysphagia after a stroke (phase 2).~   "
22315|NCT03274934|"~     The aim of this randomized control trial is to examine effectiveness of individually tailored~     web- and mobile-based Acceptance- and Commitment Therapy interventions to promote~     adolescents' well-being and life-control and subsequently support their successful transition~     from basic education to upper secondary education. Our additional aim is to examine to what~     extent the effectiveness of the intervention varies according to intervention intensity and~     according to risk for school failure. The five-week structured intervention is delivered~     using the novel web-and mobile-based program Youth COMPASS following the principles of the~     Acceptance and Commitment Therapy (ACT). The Internet context is assumed to be particularly~     motivating for youth who enjoy spending time online using different social media.~     Internet-based interventions have several advantages; they can include more information and~     treatment components than traditionally delivered treatments and that intervention programs~     are accessible at any time and at any place. Another unique aspect of the Youth COMPASS is~     the fact that it is individually-tailored. Each participant have an individually assigned~     online coach who provides support and encouragement, reminds about Youth COMPASS, sends~     individualized feedback, and recommends different exercises. The study hypothetizes that the~     Youth COMPASS is more effective than school counseling as usual. More specifically, the Youth~     COMPASS is expected to be more effective when it is combined with face-to-face support than~     when support and feedback are provided only via the Internet. Also, the Youth COMPASS with no~     face-to-face support (online only) is expected to be more effective than receiving only~     regular school counseling. Finally, the Youth COMPASS is expected to be more effective for~     students at risk for school failure than for students without risk for school failure,~     especially when at risk-adolescents receive more intensive support (i.e., both online and~     face-to-face support).~   "
22316|NCT03274921|"~     Identification of new retention solutes associated with cardiovascular (CV) toxicity in~     Chronic Kidney Disease (CKD) patients will help to better understand the pathophysiological~     mechanisms at stake and to prevent CKD-associated mortality and morbidity. For a molecule to~     be defined as a toxic retention solute, plasma accumulation in the course of CKD has to be~     demonstrated but also proof needs to be made that plasma accumulation during CKD is indeed~     associated with an increased risk of CV complications. Moreover, precise determination of the~     plasma concentration has to be performed in order to later study in vitro and in vivo the~     toxic mechanisms involved. Based on previous results of plasma proteome analysis using mass~     spectrometry, a previous study has selected 10 promising protein candidates. These proteins~     accumulated in the plasma of patients during CKD progression and are known to be associated~     with CV events in non-CKD patients. The objective of the present study is now to 1) evaluate~     the association of the plasma accumulation of the 10 retention solutes with CV complications~     in CKD patients and 2) determine their plasma concentration using ELISA. One hundred and~     seventy six patients with advanced CKD will be included and divided in 2 groups: 44 patients~     with history of CV complications in the past 4 years and 132 patients free of any CV~     complications.~   "
22317|NCT03274908|"~     This real-world study aimed at 1. exploring the relationships of traditional Chinese medicine~     (TCM) syndrome and internal diseases, 2. investigating the relationships of TCM treatment and~     internal diseases, and 3. creating medical machine intelligence to help internal physician in~     clinical practice. Big data methods and artificial intelligence algorithms are used to assess~     the associations based on electronic case files of patients.~   "
22318|NCT03274895|"~     Phase 3 study to evaluate the efficacy, safety and tolerability of 0.08% PHMB ophthalmic~     solution in subjects affected by Acanthamoeba keratitis.~      A total of 130 subjects will be assigned to one of the following 2 treatment groups:~      Group 1: 0.08% PHMB + placebo Group 2: 0.02% PHMB + 0.1% propamidine combination therapy~   "
22319|NCT03274882|"~     The purpose of this study is to evaluate the efficacy of S 95005 in patients with metastatic~     colorectal cancer (mCRC) who are refractory or intolerant to standard chemotherapies in terms~     of Progression-Free Survival rate at 2 months in the Russian population.~   "
22320|NCT03274869|"~     Scrub typhus infection has been considered as seasonal and endemic infectious disorder with~     benign feature. However, the increasing mortality rate of scrub typhus has been recently~     reported in Southeast Asia and cause of death could be a fetal complicating cardiovascular~     disease. Therefore, the association and predictors for scrub typhus induced cardiovascular~     disease should be investigated to provide a timely and appropriate diagnosis and to reduce~     the mortality rate of complicated scrub typhus infection. Therefore, we prospectively~     investigate the association and predictors of cardiovascular disease in patients with scrub~     typhus infection.~   "
22321|NCT03274856|"~     The aim of this study is to evaluate efficacy, safety, and pharmacokinetics of GLWL-01 in the~     treatment of patients with Prader-Willi Syndrome (PWS).~   "
22322|NCT03274843|"~     A non-randomized, monocentric, pilot study comparing the level of independence for each~     individual with significant resumption of activity in adult patients with stroke~   "
22323|NCT03274830|"~     The purpose of the study is the evaluation of the clinical and radiological short- to~     long-term safety and performance of the aneXys cup. The data will be used for an ongoing~     evaluation of the product safety and performance.~   "
22324|NCT03274817|"~     This is an investigator-initiated study comparing two types of FDA-approved anti-depressants,~     Escitalopram and Venlafaxine, to placebo, in order to determine if these medications have~     positive effects on cognition and memory in those who are between the ages of 50 to 89 years~     old, who are cognitively normal, and who have subjective memory concerns. Research has shown~     that those who are cognitively normal but report subjective cognitive impairment are more~     likely to progress to mild cognitive impairment and Alzheimer's disease in the future.~     Anti-depressants such as Escitalopram and Venlafaxine have been shown to stimulate production~     of neurons in memory-sensitive areas such as the hippocampus. Therefore, the investigator is~     researching whether these drugs would help cognition in those with subjective cognitive~     impairment, and would help to prevent cognitive decline and eventual Alzheimer's disease.~   "
22325|NCT03274804|"~     This is a monocentric, single arm, prospective, open-label trial of a combination treatment~     consisting of pembrolizumab and maraviroc in previously treated subjects who have refractory~     microsatellite stable (MSS) metastatic colorectal cancer (mCRC).~   "
22326|NCT03274791|"~     The aim of this study was to investigate the airway inflammatory profile and the clinical~     presentation of chronic obstructive pulmonary disease (COPD) in never smokers compared to~     smokers with COPD.~   "
22327|NCT03274778|"~     Ruxolitinib will be dispensed to patients candidate to prostatectomy immediately after~     histological diagnosis of prostate adenocarcinoma. The treatment will be given for 28 days~     followed by a prostatectomy thereafter.~      Tumor material and blood samples will be analysed before, during and after the treatment with~     Ruxolitinib.~   "
22358|NCT03274375|"~     The purpose of the study is to assess the efficacy of immunoadsorption therapy (IA) on~     improving the neurological status of severe pediatric anti-NMDAR encephalitis patients.~   "
22328|NCT03274765|"~     Patient care in Medically Assisted Procreation (MAP) requires a close and regular monitoring~     of the evolution of the estradiol rate. This monitoring allows the dose and duration of~     treatment to be accurately adjusted for each woman (every 24 or 48 hours) up to 10 to 15 days~     of treatment with gonadotrophins. Oestradiol (E2) is secreted by the growing ovarian~     follicles and reflects their growth and maturity. Its plasma dosage makes it possible to~     monitor the ovarian response to stimulation.~      This monitoring involves several constraints amongst which disruption of work life, stress,~     fatigue that can alter the response to treatment~   "
22329|NCT03274752|"~     This study evaluates the off-target effect of paroxetine to reverse cardiac remodeling and~     improve left ventricular ejection fraction in patients after acute myocardial infarction.~     Half of the participants will receive paroxetine, while the other half will receive placebo~     treatment.~   "
22330|NCT03274739|"~     This study focused on evaluating the association between adherence to the Mediterranean diet~     during pregnancy and offspring longitudinal body mass index trajectories and cardiometabolic~     risk in early-childhood. This study is part of a secondary data analysis of the INMA~     (INfancia y Medio Ambiente—(Environment and Childhood)) Project.~   "
22331|NCT03274726|"~     This analysis describes the distribution of TBI and the prevalence of iron deficiency (ID)~     and iron deficiency anemia (IDA) among toddlers, non-pregnant women, and pregnant women.~   "
22332|NCT03274713|"~     Knee osteoarthritis (KOA), also called degenerative knee disease, is one of the most common~     bone and joint diseases in clinic. It often occurs in middle-aged people, especially women.~     It was estimated to affect more than 9 million individuals in the United States in 2005 and~     is a leading cause of disability and medical costs. Most elderly people over the age of 65~     have radiographic and/or clinical evidence of osteoarthritis. KOA is a lifelong disease which~     can lead to obvious pain, joint stiffness, limitation of activity and even joint failure or~     disability.According to the papers published in the past years, we find that acupuncture~     therapy for the treatment of knee osteoarthritis include manual acupuncture,~     electro-acupuncture, acupotomy, laser acupuncture, fire needle and so on, among which manual~     acupuncture and electro-acupuncture are most commonly used.The aim of this study is to~     compare the effectiveness of electro-acupuncture and manual acupuncture in reducing pain and~     improving function in patients with KOA.~   "
22333|NCT03274700|"~     To estimate the efficacy of tamsulosin in:~      A - Expulsion of lower ureteric stones from10-15 mm diameters (primary goal).~      B - Pain relief and hyronephrosis improvement (secondary goal).~   "
22334|NCT03274687|"~     This randomized phase III trial studies how well hypofractionated radiation therapy works~     compared to conventional radiation therapy after surgery in treating patients with prostate~     cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a~     shorter period of time and may kill more tumor cells and have fewer side effects.~     Conventional radiation therapy uses high energy x-rays, gamma rays, neutrons, protons, or~     other sources to kill tumor cells and shrink tumors. It is not yet known whether giving~     hypofractionated radiation therapy or conventional radiation therapy after surgery may work~     better in treating patients with prostate cancer.~   "
22335|NCT03274674|"~     The main objective of this study is to investigate whether the for individuals with thin~     gingival thickness who are susceptible to gingival recession, the investigators will use~     i-PRF with microneedle to increase gingival thickness without the need for surgical~     procedures~   "
22336|NCT03274661|"~     Phase II trial in which patients with metastatic solid tumors experiencing progression after~     first line standard chemotherapy or for which there is no standard chemotherapy, and for~     which pembrolizumab does not have an FDA or compendia listing approved indication, will~     receive pembrolizumab intravenously at a dose of 200 mg every 3 weeks.~   "
22337|NCT03274648|"~     A dietary intervention trial will be performed on patients affected by Behçet's syndrome.~     Three different diets will be compared, analyzing their effects on the gut microbiota~     composition, on endogenous butyrate production and on the general symptoms in Behçet's~     patients.~   "
22338|NCT03274635|"~     The purpose of this study is to: (a) evaluate if a desk-based elliptical device can help~     employees to increase their daily physical activity without compromising work productivity;~     and (b) evaluate the effects of different types of incentives for pedaling the desk-based~     elliptical device on employees' pedaling quantity over a one-month intervention period. The~     study will involve placing a compact elliptical device (provided at no cost by the research~     team) under employees' desk at Penn State Hershey Medical Center/College of Medicine. Data~     evaluating the effects of the elliptical device on work productivity will be obtained from~     both employees and the employees' supervisors.~   "
22339|NCT03274622|"~     Over a 5 year period infant and baby siblings of children with autism spectrum disorders~     (ASD) will be recruited to this study and will be randomized into 2 groups. Parents of the~     intervention group will receive 6 week of coaching in how to implement this intervention.~     Parents randomized to the control group will not receive intervention coaching. Both groups~     will attend a series of clinic appointments for data collection that occur at 3 month~     intervals over a 9 month period.~   "
22340|NCT03274609|"~     In this exploratory adaptive clinical trial the investigators will examine the diagnostic~     yield of a combination of commercially available imaging and navigation techniques for~     reaching peripheral lung lesions. The two investigated techniques will herein be the rEBUS~     imaging modality combined with augmented fluoroscopy based virtual bronchoscopy navigation.~     Confirmation of reaching the lung lesion will be by means of CT (fluoroscopic) imaging. Rapid~     On-Site Evaluation (ROSE) of cytopathology will be used for obtaing a per-procedural outcome~     on tissue biopsy representativeness. The study will replace the current conventional standard~     TBB procedure (fluoroscopy and rEBUS guided bronchoscopy) in the endoscopy suite. Consecutive~     patients will be included on the MITeC hybrid operating room (needed to monitor patient~     safety and CT availability). All data will be prospectively collected. In case tissue biopsy~     is found to be malignant or benign, it will be termed representative. In case tissue biopsy~     is found to be non-representative (=blood, anatomical lung tissue, unreachable), conventional~     follow-up of CT guided TTNA, follow-up monitoring and/or surgical biopsy will serve as golden~     standard for obtaining tissue diagnosis. For verification of reaching the target lesion,~     another study parameter of interest, (cb)CT imaging will be performed for verification that~     instruments are within the nodule (per-procedurally available).~   "
22345|NCT03274544|"~     This open label clinical study will be conducted in School of Chinese Medicine Clinics at The~     University of Hong Kong (HKU) to preliminarily determine whether treatment with the herbal~     formula PROLUNG could improve Idiopathic Pulmonary Fibrosis (IPF) symptoms, respiratory~     function and the quality of life of patients with IPF compared with pretreatment baseline. We~     propose to recruit 30 participants. The diagnosis and screening will be conducted by~     respiratory physicians. Those who meet the inclusion criteria will be referred by the expert~     to the PI. The PI will prescribe the formula in granule form to the participants in~     Traditional Chinese medicine (TCM) Clinics as usual. Patients will receive 6 months of the~     herbal treatment and 7 visits.~      Annual rate of change in forced expiratory vital capacity (FVC) will serve the primary~     outcome. The St. George's Respiratory Questionnaire (SGRQ) will be used to additionally~     assess respiratory functions. A standard questionnaire will be administered to obtain~     information on age, sex, marital status, education, social class, smoking behaviour and~     respiratory diseases. Other outcome measures include the 36-Item Short Form Survey (SF-36)~     and the World Health Organization Quality of Life assessment instrument (WHOQOLBREF) by each~     participant after enrollment.~   "
22346|NCT03274531|"~     Arterial hypertension is the single largest contributor to mortality world-wide, and only~     30-50% of diagnosed and treated patients achieve their blood pressure goal. The APOTHECARE~     trial is designed to identify treated patients with uncontrolled hypertension in community~     pharmacies in order to improve blood pressure control through intensification of~     antihypertensive therapy.~   "
22347|NCT03274518|"~     Conventional hemodialysis (HD) is essential for the treatment of end-stage renal disease~     (ESRD) patients, by reducing serum concentration of uremic toxins and correcting fluid~     overload.~      Nevertheless, HD removes almost exclusively low-range uremic toxins. Therefore, medium-range~     molecules, such as beta-2-microglobulin might accumulate in tissues, leading to many clinical~     complications, such as neuropathies, tendinopathies, anemia, bone mineral disease and reduced~     growth in children.~      Convective methods might reduce incidence of these complications, by removing molecules of~     medium-range molecular weight. Online hemodiafiltration (olHDF) is the most extensively used~     method in this regard. Nevertheless, there are some barriers to the wider introduction of~     this method in clinical practice, since specific machines are needed for this procedure, the~     costs with dialysis lines are higher and water consumption increases. More recently, the~     development of new membranes for hemodialysis allowed removal of medium- and high-range~     uremic toxins, with albumin retention. Thus, they allow removal of a broad range of uremic~     toxins, without changing dialysis machine or increasing water consumption. Such therapy is~     known as expanded hemodialysis (HDx).~      The aim of this present study is to compare the extraction of middle-size molecules, the~     hemodynamic behavior, fluid and nutritional status of patients submitted to olHDF or HDx, in~     a crossover study.~   "
22348|NCT03274505|"~     Sleep disorders in the setting of stroke are numerous, including sleep-related breathing~     disorders, insomnia, excessive daytime sleepiness and restless legs syndrome. Consequences of~     theses sleep disturbances include impaired functional outcome and quality of life, anxious~     and depressive troubles and increased cardio-vascular morbi-mortality. Mechanisms underlying~     sleep disorders in the setting of stroke are complex and still partly elucidated. They~     probably involve the consequences of the ischemic lesion and of the handicap, but also of~     associated vascular risk factors and more generally pre-existent medical history, or they~     could represent themselves a risk factor for stroke. Transient ischemic attack (TIA) is a~     particular condition in which risk factors and background of patients are similar to that~     observed in stroke, without any cerebral lesion and no persistent neurological deficit. The~     main objective of the SOMN'AIC study is to compare the prevalence of sleep disorders in~     stroke and in transient ischemic attack (TIA). The study hypothesis is that the prevalence of~     sleep disorders may be higher in stroke than in TIA patients, reflecting the consequences of~     the lesion and the associated handicap.~   "
22349|NCT03274492|"~     This Phase III, randomized, double-blind, placebo-controlled study will compare the efficacy,~     safety, and pharmacokinetics of polatuzumab vedotin plus R-CHP versus R-CHOP in participants~     with previously untreated diffuse large B-cell lymphoma (DLBCL).~   "
22350|NCT03274479|"~     Phase I clinical trial in Eastern Cooperative Oncology Group (ECOG) 0-1 patients with locally~     advanced or metastatic NSCLC to evaluate safety and tolerability of the compound PBF-1129, an~     Adenosine A2b receptor antagonist. The phase I dose escalation will be conducted 3+3 method.~     Pharmacokinetic (PK) data will be also obtained.~   "
22351|NCT03274466|"~     This study evaluates surgical site complications in subjects undergoing revision of a total~     knee arthroplasty when closed incision negative pressure therapy is used to manage the closed~     incision, as compared to a standard of care dressing.~   "
22352|NCT03274453|"~     The aim of the proposed study is to examine the effectiveness of low dose postoperative~     ketamine infusion as an analgesic adjuvant to morphine pca in opioid tolerant and opioid~     naïve patients after major spine surgery. Primary endpoints of the study are to determine the~     effectiveness of postoperative ketamine infusion in for the reduction of postoperative pain~     and opioid requirements.~   "
22353|NCT03274440|"~     The purpose of this pilot research study is to test whether certain components of the~     marijuana plant, known as cannabinoids, may help to reduce symptoms in patients with OCD.~     Specifically, patients enrolled in the study will smoke marijuana containing different~     concentrations of 2 different cannabinoids, THC and CBD. Both of these agents act on the~     brain's endocannabinoid system, which has been hypothesized to play a role in OCD. Neither~     compound is currently FDA-approved for treating OCD.~   "
22354|NCT03274427|"~     The purpose of this study is to evaluate the efficacy and safety of transarterial~     chemoembolization (TACE) combined with arginine hydrochloride and trimetazidine hydrochloride~     tablets in the treatment of patients with hepatocellular carcinoma.~   "
22355|NCT03274414|"~     This study is being done to test a new treatment plan for large tumors in the sinus or nasal~     cavity that will include endoscopic surgery plus chemotherapy and proton-beam radiation~     therapy.~   "
22356|NCT03274401|"~     Patients with newly diagnosed pulmonary embolism and high thromboembolic risk will be~     randomized to screening for atrial fibrillation or standard of care using intermittent ECG~     registration for at least two weeks.~   "
22359|NCT03274362|"~     The study is a prospective, randomized, non-blinded comparative group clinical trial~     comparing participants who receive access to a mindfulness software app, Headspace, to those~     who receive standard care (i.e., a list of resources on mindfulness and health). It is~     hypothesized that participants randomized to the Headspace mindfulness application will~     exhibit greater improvement in HbA1C and quality of life measures compared to those~     randomized to standard care.~   "
22360|NCT03274349|"~     The objective or the trial is to study the influence of a combined therapy involving~     protein-rich individualized nutritional therapy and highly effective muscle training via~     personalized whole-body electromyostimulation exercise on muscle mass, muscle functionality,~     physical capability, fatigue and quality of life in patients with esophageal and bronchial~     carcinoma in advanced or metastatic stage.~   "
22361|NCT03274336|"~     1000 patients will be asked to fill out a questionnaire about preanesthetic visit right after~     the interview. On a daily randomization the Groups will be assigned to: Group A =~     face-to-face interview; Group B = interview plus brochure, Group C= interview plus movie.~      Evaluation of patient satisfaction und knowledge transfer will be evaluated with a~     questionnaire filled out right after the interview with the anesthesist.~   "
22362|NCT03274323|"~     Investigators hypothesize that the synergistic action of iStent in increasing aqueous outflow~     through the trabecular meshwork and use of prostaglandin analog such as travoprost or~     latanoprost to increase uveoscleral outflow will achieve good Intra-ocular Pressure (IOP)~     control with minimal complications in Primary Open Angle Glaucoma (POAG) patients with~     suboptimal IOP on 2 or more medications compared to mitomycin C (MMC) augmented~     trabeculectomy.~   "
22363|NCT03274310|"~     Influenza infection results in an estimated 31 million outpatient visits, 55,000 to 974,200~     hospitalizations, and 3,000 to 49,000 deaths. Membership in household in which someone else~     has influenza is the major risk factor for contracting influenza. The household secondary~     attack rate (SAR) is as high as 19% based on laboratory-confirmed influenza and 30% based on~     symptoms. Non-pharmaceutical preventive measures, including education, may play a role in~     decreasing transmission, but are only effective if started within 36 hours of symptom onset~     in index cases. Yet, most interventions are delayed because they are not initiated until care~     is sought. The investigators have demonstrated in one primarily Latino, urban community~     sample, that text messaging can be used to rapidly identify community members with~     influenza-like illness (ILI) early in an illness. This early identification would enable~     implementation of an educational intervention in the optimal time frame to reduce influenza~     transmission. Providing education within a text message is a proven successful strategy to~     influence behavior. Text messaging itself is scalable, low-cost, and can be used in low~     literacy populations. However, using text-message based surveillance to trigger a real-time~     text-message behavioral educational intervention to decrease household influenza transmission~     has not been assessed.~   "
22364|NCT03274297|"~     The purpose of this study is to determine the bioequivalence of the hormones (ie,~     norelgestromin [NGMN] and ethinyl estradiol [EE]) from the transdermal contraceptive patch~     and to evaluate the adhesion of the transdermal contraceptive patch using the newly sourced~     adhesive component, as compared to the currently marketed EVRA patch.~   "
22365|NCT03274284|"~     To evaluate the short term results of chemoradiation in case of T1G3 BC after BCG failure.~   "
22366|NCT03274271|"~     The aim of this study is to investigate the effectiveness of intervention 'MyPlan 2.0' and~     the efficacy of the different behaviour change techniques that are included. Eight groups~     will be created that will receive a different version of the intervention, varying in three~     behaviour change techniques (action planning, coping planning, self-monitoring).~   "
22367|NCT03274258|"~     Any time the words you, your, I, or me appear, it is meant to apply to the potential~     participant.~      The goal of this clinical research study is to learn if a combination of nivolumab and~     ipilimumab can help to control locally advanced or metastatic (has spread) renal medullary~     carcinoma (RMC).~      This is an investigational study. Nivolumab is FDA approved and commercially available to~     treat many types of cancer, including renal cell cancer after patients have received therapy~     to control blood vessel growth. Ipilimumab is FDA approved and commercially available to~     treat metastatic melanoma. It is considered investigational to use nivolumab and ipilimumab~     to treat RMC.~      The study doctor can explain how the study drugs are designed to work.~      Up to 30 participants will be enrolled in this study. All will take part at MD Anderson.~   "
22368|NCT03274245|"~     The objective of this research is to evaluate an intervention focused on increasing latrine~     use in rural Odisha India. The present study builds off of previous research, which resulted~     in the design of an intervention to increase latrine use. This research evaluates the~     intervention designed to determine if significant increases in latrine use are observed among~     those who received the intervention compared to those that did not. Qualitative research will~     supplement trial data collection to help explain findings and understand perceptions of the~     intervention.~   "
22369|NCT03274232|"~     Efficacy and tolerance evaluation of an intradermal injective treatment~   "
22370|NCT03274219|"~     Study CRB-402 is a 2-part, non-randomized, open label, multi-site Phase 1 study of bb21217 in~     adults with relapsed/refractory multiple myeloma (MM).~   "
22371|NCT03274206|"~     This study evaluates the efficacy and safety of the experimental drug, BLS-ILB-E710c, in~     patients with Cervical Intraepithelial Neoplasia 2/3 (CIN2/3). 2/3 of participants will~     receive the experimental drug, while 1/3 of participants will receive placebo.~   "
22405|NCT03273751|"~     This study is intended to evaluate the renal protective effect of Remote Ischemic~     Preconditioning (RIPC) in patients undergoing partial nephrectomy. Half of the enrolled~     subjects will receive 4 cycles of brief ischemia on the upper arm after anesthesia induction~     and prior to the surgery, while the other half will not receive this treatment as a control~     group.~   "
22406|NCT03273738|"~     The presence of type 2 diabetes mellitus (T2DM) also increases the relative risk of~     developing cardiovascular disease in women compared to men. Carotid intima media thickness~     (IMTc) was increased with reduction in brachial artery flow-mediated dilation (FMD) in T2 DM~     patients and inversely and strongly related to the extent of hyperglycemia. Low~     concentrations of folate and vitamin B12 involved in homocysteine metabolism are also~     associated with increased risk of vascular damage. the aim is to relate, if found, the degree~     of metabolic changes to the extent in vascular parameters changes in type 2 diabetic~     postmenopausal women.~   "
22372|NCT03274193|"~     The purpose of this study is to examine the effects of 12-week yoga training on blood~     pressure, heart rate, heart rate variability, arterial stiffness, and total peripheral~     resistance during rest and psychological stress in patients with hypertension. All eligible~     participants will be randomly assigned to either yoga (n=40) or usual care control (n=40)~     group. During the 1st lab visit, the experimenter will explain the purpose and procedures of~     the study. If the participants understand and agree to participate in this study, they will~     be asked to sign the informed consent. Next, participants will fill out questionnaires,~     including demographic information, Physical Activity Readiness Questionnaire, perceived~     stress scale, anxiety inventory, exercise behavior questionnaire, and quality of life scale.~     Participant's resting blood pressure will be measured. Participants will then be instructed~     to relax in a supine position for 15 minutes while ECG is recording. Next, participants will~     perform 5 minutes of stroop task and 5 minutes of mental arithmetic task (mental stressors).~     ECG and cardiac output will be monitored throughout the whole session. After the stress~     period, participants will be asked to relax until heart rate becomes stable and return to~     baseline. The participants will perform the sit-and-reach test. After completing all the~     baseline testing, the yoga group will begin the training program which is 60 minutes per~     session, 2 times per week for 12 weeks. The control group will be asked not to participate in~     any exercise program during the course of the study. Participants will be filling out the~     same questionnaires and receive measures of blood pressure, ECG, and cardiac output at week 6~     and week 12. Additionally, participants will perform the stress tasks and the sit-and-reach~     test again at week 12.~   "
22373|NCT03274180|"~     A non inferiority mono-centre randomised single blind prospective study comparing a medical~     consultation versus nursing consultation, into two groups parallel without crossover.~   "
22374|NCT03274167|"~     The study aims to study the effect of gabapentin on the number of alcohol drinking days and~     heavy drinking days in the Thai clinical alcohol-dependent population by using the~     double-blinded randomized controlled approach. One-hundred and twelve individuals with~     alcohol dependence were randomly assigned equally into two groups including treatment with~     gabapentin and placebo. Thirty-four patients (30.3%) completed the study protocol, i.e.~     treatment with gabapentin at least 300 mg per day or placebo orally once a day for twelve~     weeks. Pattern of alcohol drinking were obtained from the timelime followback. Drinking~     behaviors were compared between the two groups by poisson repeated measures model.~   "
22375|NCT03274154|"~     Efficacy and Tolerance Evaluation of an Anti-age Food Supplement: a Randomized, Controlled~     Clinical Study Versus Untreated Group~   "
22376|NCT03274141|"~     This is a 12 month prospective, multicenter, post-marketing, observational study to compare~     the effectiveness of a treat-to-target (T2T) disease management strategy vs. routine care~     (RC) in adult patients with moderate to severe rheumatoid arthritis (RA) treated with~     subcutaneous abatacept (Orencia - SC). Patients completing the study will be offered to~     participate in a 12-month extension of their follow-up provided that this is in agreement~     with the judgment of the treating physician.~   "
22377|NCT03274128|"~     Observation conducted during the 21 days of treatment in the health resort of~     Swieradow-Zdroj. In a treatment of applied therapy: radon therapeutic baths and inhalations,~     kinesiotherapy. Study group with degenerative joints and disc disease participating in~     therapy. The control group was selected by the spa workers, also suffering from a~     degenerative disease of the movement organs not using the spa's treatment base. In both of~     these groups, appropriate pre- and post-treatment studies were performed.~   "
22378|NCT03274115|"~     The accuracy of real-time histology prediction (hyperplastic vs. adenomas) of colonic polyps~     using white light high-definition endoscopes is suboptimal. Blue laser imaging (BLI) is a new~     system for image-enhanced endoscopy using laser light, that is incorporated in the last~     generation Fuji high- definition videocolonscopes ELUXEO. Blue laser imaging (BLI) utilizes~     two monochromatic lasers instead of xenon light: a 410 nm laser visualizes vascular~     microarchitecture, similar to narrow band imaging, and a 450 nm laser provides white light by~     excitation.This system should enhance the microvascular pattern of superficial lesions,~     making the histological prediction easier.~      Aim of the study is to compare the accuracy of white light and BLI systems in real-time~     histology prediction of colonic polyps.~      For this purpose all colonscopies will be performed in a standard fashion using white light.~     When a polyps <10mm in size will be identified, patients will be randomized in two groups. In~     the Group 1 (White Light Grroup), all polyps <10mm will be evaluated with white light and~     prediction of histology (hyperplastic versus adenomatous) will be made by means of white~     light. In the Group 2 (BLI Group) , all polyps <10mm in size will be evaluated with BLI and~     scored as hyperplastic (type 1) or adenomatous (type 2) by applying the NICE (Narrow-band~     Imaging International Colorectal Endoscopic) classification, indicating color/vessel/surface~     pattern. The level of endoscopist's confidence in predicting histology (high or low~     confidence) for any polyp will be also recorded.~      Diagnostic performances of the endoscopists (sensitivity, specificity, positive and negative~     predictive values) will be calculated comparing endoscopist's prediction and pathology~     report, considered as reference standard in both study groups in order to evaluate the~     accuracy of real-time histology prediction by using BLI or white light.~   "
22379|NCT03274102|"~     The purpose of this study is to evaluate the safety and immunogenicity of concomitant~     administration of EV71 vaccine with recombinant hepatitis B vaccine/Group A meningococcal~     polysaccharide vaccine.~   "
22380|NCT03274089|"~     The chronic disease burden is increasing worldwide leading to a rise in the demand for~     primary healthcare and a shortage of primary care physicians. Addressing this shortage~     entails a multi-prong approach with innovations in care delivery, greater use of healthcare~     technology, and more efficient use of all healthcare providers on the care team.~      We previously developed an interactive self-service healthcare kiosk (Self-empowering and~     enabling kiosk - SEEK® MyHealthKiosk) for the management of patients with stable chronic~     disease in the primary care setting. A feasibility study using SEEK showed high levels of~     acceptance and satisfaction from patients and healthcare providers.~      The aim of this follow-up study is to evaluate the health outcomes of patients with stable~     chronic disease who are on kiosk management compared to patients who are on routine~     management by nurse clinicians. We hypothesize that patients who are managed by the kiosk~     continue to maintain good blood pressure and diabetic control that are comparable to patients~     who are managed by a nurse clinician.~   "
22381|NCT03274076|"~     This study will evaluate tofacitinib treatment in subjects with diffuse cutaneous systemic~     scleroderma (dcSSc) in a placebo controlled trial. This phase I/II study is intended to~     provide safety, and tolerability data in participants with dcSSc when dosed to target~     exposures similar to that used in adult participants with RA.~   "
22382|NCT03274063|"~     This study evaluates whether a supported self-management approach to gout is able to achieve~     target levels of serum urate, and better control of gout flares.~   "
38558|NCT03061981|"~     This is a randomized, double blind, placebo controlled, single ascending dose study to assess~     the safety, tolerability, PK, PD and IE with metformin following a single oral dose of~     DA-1241 in healthy male subjects.~   "
22383|NCT03274050|"~     Robotic minimally invasive surgery has been rapidly adopted for a wide variety of surgical~     procedures in adult patients across a broad spectrum of surgical specialties. This has~     occurred despite the high costs and uncertain benefits of surgical robots.~      In contrast, Children's Hospitals and pediatric surgical disciplines have been much slower to~     embrace the surgical robot. Many children's hospitals do not even possess a surgical robot,~     and many of those that do borrow them from the adult operating room within the same medical~     facility.~      Since the first case of robotic minimally invasive surgery in children in 2000, robotic~     procedures have been slowly adopted by select pediatric surgical specialists.~      Advocates of robotic minimally invasive surgical systems tout many useful features that~     include improved dexterity, motion scaling, tremor filtration, greater optical magnification~     (up to 10x), stereoscopic vision, operator-controlled camera movement, and the elimination of~     the fulcrum effect when compared to conventional laparoscopy. The wristed laparoscopic~     instruments used in robotic surgery provide seven degrees of freedom.~      For the surgeon, these features may allow for more precise dissection with increased~     magnification and visibility. The intuitive controls of the robot are purported as providing~     the ability to perform laparoscopic procedures in an open fashion. In pediatric surgical~     procedures, these technical abilities may have the potential to surpass the physical~     capabilities of human performance in the tight operative fields encountered in children.~      This study aims to evaluate the clinical safety and efficacy in a dedicated multidisciplinary~     pediatric program and to evaluate the relative cost of robotic surgery~   "
22384|NCT03274037|"~     MRI elastography detects the movement of tissues in the human body and monitors their~     response to mechanical stress in order to reveal their mechanical properties, like palpation.~     These depend on the structure of the tissues, their biological conditions and possible~     conditions. This non-invasive technique allows exploration of deep organs such as the brain~     that the doctor's hand can not reach. MRI elastography may prove to be an essential tool for~     study, diagnosis, staging and therapeutic monitoring of brain diseases.~      Neurodegenerative diseases (Alzheimer's, Parkinson's, Creutzfeldt-Jakobes) and cancers~     largely modify the mechanical properties of the affected tissues. For a first evaluation of~     the technique, we are interested in glial tumors representing half of the intracranial tumors~     in adults (incidence: 5 cases per 100 000 inhabitants), the second cancer in children and the~     third cause of death in l Young adult.~   "
22385|NCT03274024|"~     Comparison of Ahmed Glaucoma Implant (AGI) against trabeculectomy with mitomycin C in~     patients with uncontrolled open angle glaucoma~   "
22386|NCT03274011|"~     There is no standard treatment strategy for recurrent or metastatic esophageal squamous cell~     carcinoma patients now, especially after the second-line treatment. Most of the patients have~     the bad ECOG (Eastern Cooperative Oncology Group) score and prognosis. Chemotherapy,~     radiotherapy, surgery are usually unacceptable for them. Previous data showed that apatinib~     treatment significantly improved OS(overall survival) and PFS(progression-free survival) with~     an acceptable safety profile in patients with advanced gastric cancer refractory to two or~     more lines of prior chemotherapy. Our study will observe the efficacy and safety of Apatinib~     for recurrent or metastatic esophageal squamous cell carcinoma: A phase II, prospective,~     single-arm, multicenter trial.~   "
22387|NCT03273998|"~     Blood coagulation is a complex mechanism that is required for the rapid establishment of a~     stable fibrin clot. A series of interdependent enzyme-mediated reactions translate the~     molecular signals that initiate blood coagulation into the formation of the fibrin clot.~     Congenital coagulopathies result when there is a deficiency of protein co factors and enzymes~     implicated in blood coagulation~   "
22388|NCT03273985|"~     To date, there are not studies about the effectiveness of dry needling versus ischemic~     compression in the triceps surae trigger points. A randomized clinical trial is carried out.~     A sample of 30 subjects are recruited and allocated into dry needling (n = 15) and ischemic~     compression (n = 15). Outcome measurements such as dorsal flexion range of motion, plantar~     pressures, temperature, superficial muscle activity and trigger points pressure pain~     threshold are measured immediately before and after treatment.~   "
22389|NCT03273972|"~     The INTENSITY-LOW study aims to answer if there are any limits to LDL reduction in relation~     to benefitting vascular health from a mechanistic viewpoint, and therefore potentially~     limitations to primary prevention in healthy volunteers by lowering LDL cholesterol using~     PCSK9 therapies. This research is being carried out because it is unclear what the lowest~     threshold of LDL cholesterol should be to attain significant reductions in CV risk in healthy~     individuals. It is also unknown whether there is a true limit of LDL cholesterol below which~     there is no further improvement in endothelial function in healthy people, and, whether this~     is associated with a reduction in markers of both systemic and vascular inflammation. This~     study will hope to provide evidence that the so-called pleiotropic effects of statins are~     actually mediated by a mechanism of LDL-cholesterol lowering per se and not necessarily a~     special therapeutic effect of statins.~      Defining this may help identify individuals from the general population who may benefit from~     more aggressive lipid-lowering treatment than standard statin treatment in terms of CV~     morbidity and mortality.~      This study will be conducted in healthy volunteers only, where participants will be~     randomized to either the Alirocumab arm (which is a therapy designed to lower cholesterol) or~     comparator arm. Both Alirocumab and comparator arms will be combined with Atorvastatin~     (another therapy designed to lower cholesterol) at the second dosing visit.~      In total, thirty healthy individuals will be recruited to this single centre, randomized,~     single blind, parallel group, mechanistic physiological study which will be conducted at~     Cambridge University Hospitals NHS Foundation Trust/University of Cambridge. This study will~     be open to recruitment for one year and the total study duration for each participant will be~     approximately 10 weeks. There will be 4 study visits in total with a telephone follow up at~     the end of the study. Of these visits, two will be dosing visits and the total duration of~     treatment is approx. 4 weeks.~      A series of non-invasive haemodynamic assessments and minimally invasive procedures including~     blood tests and forearm blood flow measurements will be conducted prior, during and post~     dosing to determine if there is an improvement of endothelia vascular function (as measured~     by nitric oxide bioavailability) and reduced systemic inflammation. This study is funded by~     JP Moulton Charitable Foundation.~   "
22390|NCT03273959|"~     The objective of this study was to evaluate the effect of a physical exercise program on the~     functional capacity of children and adolescents with cystic fibrosis hospitalized at the~     Hospital de Clínicas of Porto Alegre (HCPA) through a six-minute walk test using the distance~     traveled In six minutes.~      In the first 48 hours of hospital stay, the following evaluations will be performed:~     Six-minute walk test, physical and health fitness test, spirometry and data collection.~     Patients will be randomized to either control group or intervention group. The control group~     will receive the conventional treatment offered by hospital care, the intervention group will~     receive this same treatment plus an exercise protocol. After 14 days they will be reevaluated~     with the same tests applied at the beginning of hospitalization.~   "
22407|NCT03273725|"~     The main aim of this study is to investigate potential associations between maternal pre- and~     postnatal vitamin D level and oral health outcomes (caries and developmental defects of~     enamel) in their children at 7-9 years of age.~   "
22391|NCT03273946|"~     For the prophylactic treatment of asthma, FP inhaled aerosol (Flixotide ®) administered via a~     pressurized metered-dose inhaler (pMDI) was approved in China in adults, adolescents older~     than 16 years of age and children aged 4 to 16 years. This post-marketing safety monitoring~     program will evaluate the safety profile of FP 50 micrograms (µg) inhaled via a pediatric~     spacer device with a face mask in Chinese subjects aged 1 to <4 years. The adverse drug~     reactions (ADRs) and predictors of these adverse reactions among subjects will be reported.~     This single arm observational study will include subjects prescribed with FP 50 µg inhaled~     via a pediatric spacer device with a face mask. The maximum duration of the study will be 12~     weeks with 3 visits. Visit 1 (Day 1) will be on-site visit and will also mark the start of~     the observational program. The follow-up visits will be scheduled at Visit 2 (Week 4), and~     Visit 3 (Week 12) conducted on site or by telephone. A total of 150 asthmatic subjects who~     have been prescribed FP 50 µg treatment for appropriate medical use for the first time in~     China will be enrolled in the study. Flixotide is a registered trademark of GlaxoSmithKline~     (GSK) group of companies.~   "
22392|NCT03273933|"~     Randomized clinical trial to assess acquisition and maintenance of paediatric asthma control~     through innovative devices supporting usual care. In the first study arm, a new application~     (DragONE) for iOS and Android will be only used for patient monitoring. In the second study~     arm, a small portable device (SmartONE) will also be connected to the DragONE APP, for daily~     assessment of the peak expiratory flow (PEF). The study duration is 12 weeks. The main~     outcome of the study is the Childhood Asthma Control Test (C-ACT) score, assessed once every~     4 weeks for 12 weeks.~   "
22393|NCT03273920|"~     This study is an investigator-initiated, randomized, controlled, parallel group, and~     non-inferiority trial comparing robot-assisted gastrectomy with D2 nodal dissection for~     locally advanced gastric cancer patients with laparoscopic procedure.~   "
22394|NCT03273907|"~     The purpose of this study is to demonstrate that the rate of clinically relevant~     complications associated with CyPass Micro-Stent placement and stability using the CyPass~     241-S applier, as determined at 36 months in the postmarket setting, is less than the~     pre-specified performance target, which is based on experience with the CyPass Model E~     applier in the COMPASS (TMI-09-01) Trial.~   "
22395|NCT03273894|"~     Perioperative hypothermia carries high risk of associated complications. In the observational~     study, the standard perioperative temperature management will be evaluated and the influence~     of the hypothermia on the coagulation system according to routine coagulation testing in~     combination with ROTEM will be evaluated.~   "
22396|NCT03273881|"~     This study aims to examine the effect of intrapartum treatment of diabetic women with~     combined glucose and constant insulin infusion compared to glucose alone on the incidence of~     neonatal hypoglycemia. Pregnant women with diabetes in pregnancy will be randomly divided~     during labor to 2 groups: group 1, will receive intravenous glucose with constant insulin~     infusion; group 2 will receive intravenous glucose alone. The primary outcome is the~     incidence of neonatal hypoglycemia.~   "
22397|NCT03273868|"~     This study evaluates the effect of a single high-velocity low amplitude thoracic manipulation~     on both autonomic nervous system activity and pressure pain threshold.~      It is a crossover study, thus, each participant will undergo both interventions (thoracic~     spinal manipulation or a sham manipulation). The two interventions will be separated by a 48~     h washout period.~   "
22398|NCT03273855|"~     This is a randomized, double-blinded and placebo controlled prospective trial with sixty~     patients to investigate the effect of fecal microbiota transplantation (FMT) on body weight~     in patients with severe obesity. We will also collect data that possibly could give a better~     understanding of mechanisms of this correlation.~   "
22399|NCT03273842|"~     This study compares the immune response to the proposed biosimilar PF-06881894 and the~     US-approved Neulasta reference product. Subjects will receive 2 subcutaneous injections (6~     milligrams [mg]) either 1 of the 2 study drugs. Subjects will receive the first dose on Day 1~     of Period 1 and the second dose on Day 1 of Period 2. Pre-dose and serial post-dose~     assessments of immunogenicity will be conducted each of the two treatment periods. In~     addition, safety assessments will be conducted throughout the study.~   "
22400|NCT03273816|"~     Deep brain stimulation surgery, which consists of intracerebral implantation of electrodes,~     is considered one of the most effective techniques for controlling the motor fluctuations of~     Parkinson's disease. The particularity of this surgery is the necessity of the awakening of~     the patient for the correct positioning of the electrodes, it is therefore a difficult test~     for the patient.~      Medical sophrology is an ideal strategy to optimize the comfort of the patient during the~     operation thanks to its anxiolytic and analgesic virtues while guaranteeing the maintenance~     of a good patient vigilance favoring the cooperation with the operating room team. Indeed,~     sophrology is a body-mediated set of techniques, at the crossroads between hypnosis and yoga,~     which makes it possible to find a balance between emotions, thoughts and behaviors. It has~     already been applied in other fields such as oncology, pain management, preparation for~     childbirth, and for 5 years at the CHU of Rennes for preparation for the intervention of deep~     brain stimulation.~   "
22401|NCT03273803|"~     The investigators performed a proof-of-concept study enrolling subjects with normal and~     pathologic heart sounds. Heart sound was recorded by auscultation on the skin of the chest~     wall using three smartphones: Samsung Galaxy S5 and Galaxy S6, and LG G3 . Recorded heart~     sounds were processed and classified by a diagnostic algorithm using convolutional neural~     networks.~   "
22402|NCT03273790|"~     A Retrospective Study of the Effectiveness and Safety of Nivolumab in Advanced/Metastatic~     Non-Small Cell Lung Cancer (NSCLC) Patients in Japan~   "
22403|NCT03273777|"~     Skin incision skewness, incision length on both sides of the midline and patient's perception~     of the scar after cesarean section will be compared between the following two groups: (1)~     Drawing of an incision line prior to skin incision and (2) no drawing of an incision line.~   "
22404|NCT03273764|"~     To develop a comprehensive ʻClinical RD score' for decision making for administration of~     Surfactant in respiratory distress syndrome in preterm infants with gestation of 26 0/7 - 34~     6/7 weeks and to assess the validity of this ʻclinical RD score' on a different subgroup of~     patients with similar gestational age.~   "
22408|NCT03273712|"~     This is a Phase 2 peptide receptor radionuclide therapy trial of 90Y-DOTATOC in patients with~     somatostatin receptor positive tumors.~   "
22409|NCT03273699|"~     The Frederick W. Thompson Anxiety Disorders Centre has experienced significant demand for~     services related to the treatment of Obsessive Compulsive Disorder (OCD), resulting in a~     significant wait time for service. Although Cognitive Behavior Therapy (CBT) is the most~     efficacious treatment intervention for OCD, there is a growing literature indicating the~     mindfulness based approaches can be beneficial in terms of managing acute mood and anxiety~     symptoms as well as reducing relapse risk following treatment.The goal of this study is to~     examine the potential benefits of using a consumer grade EEG-based biofeedback device that~     allows clients to engage in home based mindfulness meditation practices while they are~     waiting to receive clinical services. Specifically, this study will investigate the effects~     of meditation home practice on symptom alleviation, as related to specific OCD related~     cognitive processes.~   "
22410|NCT03273686|"~     Nasogastric decompression is standard practice after esophageal resection in most centers~     because it is expected to reduce the incidence of esophagogastric anastomotic leakage by~     preventing overdistension of the gastric conduit. Most esophageal surgeons have been~     reluctant to move away from this tradition because of the considerable morbidity of~     anastomotic leaks after esophagectomy. However, a contrarian view is that the use of~     prolonged NGD may increase the incidence of postoperative pulmonary complications by~     promoting aspiration. Considering the numerous complications caused by using the tube and the~     uncertainty about its usefulness and the scarcity of studies conducted on the subject,~     particularly in patients with esophageal cancer, the necessity of using the tube in these~     types of cases is investigated in the present study.~   "
22411|NCT03273673|"~     ACL injuries are common among athletes and due to residual muscle weakness, limited knee~     motion and asymmetrical movement patterns after surgery many of these athletes will sustain~     secondary ACL injuries following return to sports. This project seeks to determine if a novel~     biofeedback-based rehabilitation approach can decrease a known risk factor for secondary~     injuries to the ACL. The project specifically focuses on correcting asymmetric movement~     patterns, a known risk factor for secondary injury that is not directly addressed by existing~     interventions through a 6 week therapy based biofeedback intervention.~   "
22412|NCT03273660|"~     Aim of the study is to evaluate the re-volumizing performance and the duration effect of the~     product Aliaxin (new trademark) in women aged 40-65 years with midface volume defects due to~     aging mechanism.~   "
22413|NCT03273647|"~     The purpose of this study is to determine the efficacy of adjuvant radiotherapy for~     esophageal squamous cell carcinoma with positive circumstantial resection margin.~   "
22414|NCT03273634|"~     Feeling of palpitations with no clear arrhythmia is frequently encountered in clinical~     practice. The majority of these patients have documented sinus rhythm even while having~     symptoms. Gastrointestinal association with such symptoms was first described by Ludwig von~     Roemheld (1871-1938).The investigators thought to investigate the effect of proton pump~     inhibition in patients with feeling of palpitations but no clear cause.~   "
22415|NCT03273621|"~     The aim of this study is to measure the volume of the epicardial adispose tissue (EAT) and~     other morphological and functional cardiovascular parameters in subjects with severe obesity,~     using an open magnetic resonance unit capable of holding up to 220 kg of weight. These~     measurements will be repeated a year after bariatric surgery to assess the effect of the~     weight loss on EAT. The possible difference among different types of bariatric surgery will~     be considered.~   "
22416|NCT03273608|"~     The purpose of this multicenter registry is to gather the safety, efficacy and survival data~     in intermediate and advanced HCC patients treated drug-eluting microsphere in Taiwan in order~     to provide clinical evidence in HCC management to physicians in the region, and to support~     the application of deTACE in treating advanced HCC patients.~   "
22417|NCT03273595|"~     This is a prospective, open-label, real-word study evaluating the efficacy and safety of~     lapatinib in combination with chemotherapy versus trastuzumab in combination with~     chemotherapy in women with HER2-positive and p95HER2-positive ,or PI3K mutation, or PTEN loss~     breast cancer . Eligible subjects will have newly diagnosed breast cancer (Stage II-III) ;~     not have received systemic or local treatment . The primary endpoint was the rate of~     pathological complete response (pCR). The secondary objectives are to evaluate overall~     survival, overall response rate, clinical benefit response rate and the safety as well as~     tolerability of lapatinib plus chemotherapy and trastuzumab plus chemotherapy.~      Patients will receive lapatinib 1000 mg daily or trastuzumab 4 mg/kg intravenous (IV) load~     followed by 2 mg/kg IV weekly for a total of 12 weeks. After surgery, patients planned total~     duration of the anti-HER2 therapy will be one year.~   "
22418|NCT03273569|"~     The aim of this study is to evaluate a novel protocol to conserve the uterus during Cesarean~     delivery indicated for placenta accreta.~   "
22419|NCT03273556|"~     Evaluation of the filler performance on the nasolabial folds of Aliaxin® EV with and without~     lidocaine 0.3%: comparison within subjects (half face method)~   "
22420|NCT03273543|"~     To determine if subjects who receive premaxillary injection demonstrate an increase in nasal~     tip projection and an associated increase in upper lip projection, and vermillion height.~   "
22421|NCT03273530|"~     In this randomized controlled trial, the researchers investigated the effectiveness of~     integrated supported employment (ISE) as compared with individual placement and support (IPS)~     and traditional vocational rehabilitation (TVR) for people with schizophrenia in mainland~     China.~   "
22422|NCT03273517|"~     Historically, adults and children who undergo elective surgery remain fasting in the~     preoperative period, for the purposes of avoiding bronchial aspiration of the gastric~     contents during general anesthesia. The determination of preoperative fasting has taken on~     importance only in 1946, when Mendelson established a relationship between pulmonary~     aspiration during labor and general anesthesia. Stemming from other studies, such concept has~     been expanded to elective surgery and 25 ml were set as the maximum threshold of the gastric~     content to thus reduce the hazards of aspiration pneumonia.~      The fasting time prescribed is still the subject of several investigations. For decades it~     has been established that patients should not feed on solids or ingest liquids over a period~     of 8 to 12 hours prior to surgery.~      The guidelines are well set in connection with the rules of fasting, with aims at making the~     instructions constant throughout different services worldwide. In 2011, the American and the~     European guidelines became more permissive and determined as safe the 2 hours for liquids~     devoid of residue, 4 hours for breast milk, 6 hours for infant formula and non-human milk, 6~     hours for light meals, and 8 hours for full meals. In accordance with the American guideline,~     liquids devoid of residue are: water, fruit juice with no pulp, carbohydrate-based beverages,~     tea with no residue, and black coffee, but those examples are not extensive. Gelatin is solid~     prior to intake, but it is found in a liquid state inside the stomach and, therefore, it is~     regarded as a liquid devoid of residue. Yet, in spite of the non-human milk's being a liquid~     material, it features a gastric emptying time which is similar to that of the non-fat solids.~     A light meal is characterized by toast and liquids devoid of residue, whilst a full meal~     includes food that is fried or which contains a high level of fat.~      Currently, many directives (American Society of Anaesthesiologists - ASA; Norwegian National~     Consensus Guideline - NNCG; Association of Anaesthetists of Great Britain and Ireland -~     AAGBI) recommend liquids devoid of residue until two hours prior to the anesthetic induction~     for elective surgery in healthy children. The particular benefit of the oral intake of fluids~     includes a lower incidence of deleterious effects, such as thirst, irritation, crying,~     hypoglycemia, and dehydration. The preservation of the intravascular volume improves the~     hemodynamic conditions during the induction of inhalation anesthesia and facilitates the~     vascular access.~      Even though the old instruction of nothing by mouth after midnight is in a process of being~     replaced by shorter periods of fasting, both surgeons and anesthesiologists still deem the~     traditional fast indispensable and have trouble with implementing the new norms, either by~     uncertainty before the possibility of the catastrophic consequences of pulmonary aspiration,~     or by lack of update on the subject. That matter generates mistakes in the rendering of~     information by the health professionals. Combined with the unawareness of the guardians in~     respect of the risk of bronchial aspiration and the anxiety in relation to the fasting, there~     is a result of difficulty in abidance by the proper preoperative fasting.~      The minority of the guardians understands the real importance of the preoperative fasting~     and, many times, food regarded as harmless is offered during the period of fasting.~     Likewise, the guardians provide improper information in order to maintain the surgical~     procedure, with no regard for the correct observance of the fasting. That way, countless~     pediatric elective surgeries are canceled, deriving in psychological, social, and economic~     implications. The correction of these flaws will allow for the anesthetic procedure to take~     place in a more secure manner, with the proper observance of the fasting period and with the~     least possible trauma to the child.~   "
22423|NCT03273504|"~     Aim of the study is to evaluate clinically and by non-invasive instrumental evaluations the~     activity on hair regrowth of a topical cosmetic product versus placebo (comparison within~     subjects)~   "
22424|NCT03273491|"~     The primary objective of this study is to experimentally test the momentary and more distal~     psychological effects of daily self weighing as compared to an active control group.~   "
22425|NCT03273478|"~     To assess safety and efficacy of pCONUS2 for the treatment of wide neck bifurcation~     aneurysms.~   "
22468|NCT03272906|"~     Study Design: This is a within-subjects crossover design. Subjects will participate in the~     procedures twice, once under each condition (active vs. sham stimulation). The order of~     conditions will be counter-balanced across subjects. Stimulation will target ventral inferior~     frontal gyrus (IFG) and will be paired with standard speech-language therapy. Outcome~     measures will be acquired at the beginning and end of a semester of standard speech-language~     therapy, and at follow-up.~   "
22426|NCT03273465|"~     Fecal Microbiota Transplantation(FMT) - reconstitution of normal flora by a stool transplant~     from a healthy individual, is increasingly being recognized as a therapeutic modality for~     diseases that are associated with gut dysbiosis.~      This is a placebo-controlled, double blinded interventional study evaluating multiple, oral,~     fecal microbiota transplantation, administered in newly diagnosed adult patients with~     mild-moderate UC.~      The primary objective is to assess the safety and feasibility of multiple, oral, fecal~     microbiota transplantation,in newly diagnosed adult patients with mild-moderate UC.~      All processing will occur at the Center for Microbiome Research at Assaf Harofeh Medical~     Center, under GMP conditions.~   "
22427|NCT03273452|"~     This study aims to investigate the efficacy and safety of PET regimen combined with Chidamide~     for angioimmunoblastic T cell lymphoma patients.~   "
22428|NCT03273439|"~     In this study, we assessed the therapeutic effects and safety of left dorsolateral prefrontal~     cortex (DLPFC) high-frequency repetitive transcranial magnetic stimulation (rTMS) on negative~     symptoms of schizophrenia. We evaluated the efficacy of rTMS on cognition in patients with~     chronic schizophrenia.~   "
22429|NCT03273426|"~     The purpose of this study is to evaluate the ability of preoperative biopsy to predict~     correctly pathologic complete response in breast cancer patients with complete clinical~     response after neoadjuvant chemotherapy.~   "
22430|NCT03273413|"~     This study plans to learn if pravastatin is helpful in slowing down the progression of kidney~     disease in adults with autosomal dominant polycystic kidney disease (ADPKD). Pravastatin has~     been approved by the Food and Drug Administration (FDA) for adults for treatment of~     hyperlipidemia (high cholesterol levels). The investigators are using pravastatin in this~     study as an investigational drug for treatment of ADPKD.~   "
22431|NCT03273400|"~     To compare the immediate and short-term effects of L4 and L5 Unilateral Posterior Anterior~     (UPA) Mobilisations on the lumbar and hamstring range of motion and EMG activity of the~     Erector Spinae and Hamstring muscles.~      Using a pre-test post-test crossover design subjects lumbar flexion and active knee extension~     with be recorded prior to and following unilateral zygapophyseal joint mobilisations.~     Measures will be taken immediately after and then 5, 10, 15, 20, 30 and 60 minutes intervals~     post intervention. Mobilisation force will be measured via force plates to ensure consistent~     mobilisation pressure.~      Following data collection statistical analysis will be undertaken to analyse any potential~     benefit of lumbar mobilisations to influence the EMG activity of the Erector Spinae and~     Hamstrings. Functional assessment of lumbar range of motion and hamstring range of motion to~     be conducted and analyse any effect on movement~   "
22432|NCT03273387|"~     Right ventricular dysfunction is the worst mortality predictor in pulmonary arterial~     hypertension (PAH). Recent study has described that approximately 25% of PAH patients will~     developed into right ventricular failure despite therapeutic reduction of pulmonary vascular~     resistance. Subsequently, several studies have shown that fatty acid accumulation in right~     ventricle was inversely correlated with right ventricular function in PAH patients. Several~     PAH animal studies have revealed that metabolic glucose oxidation impairment through~     increased aerobic glycolysis, mitochondrial dysfunction, and lipotoxicity play significant~     role in right ventricular failure. Moreover, several pulmonary hypertension animal studies~     have demonstrated the benefit of partial fatty acid inhibitor such as trimetazidine on right~     ventricle function. It was hypothesize that trimetazidine improved right ventricular function~     through indirect effect of increased glucose oxidation by blocking the Randle cycle.~     Therefore, we hypothesize that trimetazidine can improve right ventricular function in~     pulmonary arterial hypertension patients.~   "
22433|NCT03273374|"~     This phase II study is designed to investigate the efficacy of IORT for patients with~     resectable pancreatic adenocarcinoma. The purpose of the study is to show the local~     recurrence rate after surgical resection and IORT is superior to that of surgical resection~     alone from the historical control. A total of 42 patients will be enrolled, and these~     patients will receive IORT of 10 Gy at 5 millimeter depth of the tumor bed, followed by 6~     cycles of adjuvant gemcitabine chemotherapy.~   "
22434|NCT03273361|"~     This lab study is evaluating the feasibility of accomplishing productive office work while~     simultaneously pedaling a compact desk-based cycling device.~   "
22435|NCT03273348|"~     Role of Oncoplastic Breast Surgery In Breast Cancer Treatement~   "
22436|NCT03273335|"~     (From NIH reporter) Each year >16 million older Americans undergo anesthesia and surgery, and~     up to 40% of these patients develop postoperative cognitive dysfunction (POCD), a syndrome of~     postoperative thinking and memory deficits. Although distinct from delirium, POCD (like~     delirium) is associated with decreased quality of life, long term cognitive decline, early~     retirement, increased mortality, and a possible increased risk for developing dementia such~     as Alzheimer's disease. Understanding the etiology of POCD will likely help promote~     strategies to treat and/or prevent it. A dominant theory holds that brain inflammation causes~     POCD, but little work has directly tested this theory in humans. The preliminary data of this~     team strongly suggest that there is significant postoperative neuro-inflammation in older~     adults who develop POCD. In this K76 award, the investigators will prospectively obtain pre-~     and post-operative cognitive testing, fMRI imaging and CSF samples in 200 surgical patients~     over age 65. This will allow the investigators to evaluate the role of specific~     neuro-inflammatory processes in POCD and its underlying brain connectivity changes.~   "
22437|NCT03273322|"~     Evaluation of 2 doses of rivaroxaban (10 and 15 mg) compared to dual anti platelet therapy~     (aspirin+clopidogrel) after left atrial appendage closure. The patients will be assessed at~     10 and 90 days: central laboratory hemostasis analysis and clinical events assessment.~   "
22438|NCT03273309|"~     Aim: To compare the effects of Vibratory Perineal Stimulus with transvaginal electrical~     stimulation to the pelvic floor muscles functionality in women with urinary incontinence and~     who are unable to voluntarily contract their pelvic floor muscles.~      Study Design: Randomized controlled trial~   "
22485|NCT03272672|"~     The purpose of this study is to determine the effect of a valgus unloader brace condition on~     the acute change in medial femoral condyle cartilage morphology using Ultrasound following a~     standardized walking protocol.~   "
26380|NCT03221673|"~     This is a cross-sectional study aiming to identify how daily activities affect children's~     body fitness and general health. Also, the study will address how specific behaviors (such as~     diet and sleep) as well as neighborhood and home environment affect children's metabolic~     health and fitness level.~   "
22439|NCT03273296|"~     In recent years it has been observed that the gut microbiome can produce metabolites into~     systemic circulation and thus have important health effects even outside the gastrointestinal~     system. These metabolites may play a role in the pathogenesis of common public health~     problems such as diabetes, obesity and cardiovascular disorders. Modern techniques of mass~     spectrometry-based metabolomics from peripheral blood and gut metagenome sequencing now~     enable detailed examination of these processes. Using samples from the FINRISK 2002 cohort,~     collected by the National Institute for Health and Welfare, we are currently determining the~     gut microbiome and plasma metabolome from > 7000 participants with 15 years of follow-up for~     various health outcomes. This is one of the largest materials of its kind world-wide. The~     design does not, however, allow us to draw causal conclusions on the roles of gut bacteria in~     the composition of plasma metabolome. To enable conclusions which go beyond statistical~     associations, we now propose an extension to the FINRISK 2002 study, where we alter the gut~     bacteriome with a short course of antibiotics and then examine whether a change in plasma~     metabolomics profile will follow. At the same time the trial will give important novel~     information about the effects of commonly used antibiotics on gut bacteriome and on general~     health.~   "
22440|NCT03273283|"~     Alcohol use and its consequences represent an important public health problem. As well as~     alcohol dependence, hazardous drinking also contributes to a high burden in terms of~     morbidity and mortality. To improve these patients' prognosis and decrease associated social~     and health care costs, it is necessary to increase early detection, intervention and~     treatment for these problems. For these reasons, SBIRT programmes (Screening Brief~     Intervention and Referral to Treatment) have been developed, evaluated and shown to be~     effective, particularly in primary care and general practice. Nevertheless, effectiveness of~     SBIRT in emergency departments (ED) has not been clearly established.~      The investigators aimed to evaluate the feasibility and efficacy of an SBIRT programme in the~     ED of a tertiary hospital.~   "
22441|NCT03273270|"~     Freezing of gait (FoG) is a common and debilitating condition in Parkinson's Disease (PD)~     patients. FoG is described as an episodic inability to walk, which often triggers falls,~     hospitalization and is an important predictor of poor quality of life. As locomotor regions~     degenerate in PD, gait automaticity is impaired. Patients compensate by increasing volitional~     control of gait, however, this adaptation has been found to worsen FoG severity. We~     hypothesize that increased cortical control of gait is maladaptive, and therapies to improve~     gait automaticity will not be effective unless cortical control of gait is reduced. The~     long-term goal of this project is to develop a therapeutic approach for FoG that~     simultaneously reduces cortical control and increases automaticity of gait. The objective is~     to determine the locomotor network abnormalities responsible for FoG and demonstrate how~     neuromodulation and rehabilitation can modulate the network. The rationale of this study is~     that increased connectivity between brainstem locomotor regions and cortical structures~     represents increased cortical governance of gait, and it can be reversed by the proposed~     intervention. We will accomplish this by combining a course of inhibitory rTMS (1Hz) to the~     cortex (supplementary motor area) with a rehabilitation protocol designed to increase gait~     automaticity (dual task training). We have designed a study that will carefully assess the~     locomotor network of freezers with resting state functional, diffusion and interleaved~     TMS/BOLD MRI studies, before and after intervention. Behavioral measures including gait~     analysis, cognitive and motor assessments will also be conducted at baseline and post~     treatment. The study aims to determine the effects of our intervention on the locomotor~     network (assessed with imaging), as well as on FoG severity as quantified through multiple~     markers obtained through gait analysis. At the conclusion of the study we expect to have~     determined the network changes central to the pathophysiology of FoG, the effects of 1Hz rTMS~     + rehabilitation on this network, and on FoG severity.~      The relevance of this study to public health is to develop a non-invasive effective~     therapeutic option for one of the most debilitating and untreatable conditions affecting the~     lives of one million Americans suffering from PD; freezing of gait.~   "
22442|NCT03273257|"~     This is a randomised, double-blind, placebo-controlled, multicentre, multinational,~     prospective study in patients with operable chronic thromboembolic pulmonary hypertension~     (CTEPH) prior to pulmonary endarterectomy (PEA) with high preoperative pulmonary vascular~     resistance (PVR). Patients will be randomised in a 1:1 ratio to receive riociguat or matching~     placebo for 3 months before undergoing PEA. The primary objective of this study is to assess~     the efficacy of riociguat on preoperative PVR compared to placebo in patients with operable~     CTEPH.~   "
22443|NCT03273244|"~     Background. In case of untreatable suffering at the end of life, palliative sedation may be~     chosen to assure comfort by reducing the patient's level of consciousness. An important~     question here is whether such sedated patients are certainly completely free of pain. Because~     these patients cannot communicate anymore, caregivers have to rely on observation to assess~     the patient's comfort. Recently however, more sophisticated techniques from the neurosciences~     (fMRI, EEG) have shown that sometimes consciousness and pain is undetectable with these~     traditional behavioral methods.~      Therefore there is an urgent need for a more reliable way of assessment by combining existing~     observational scales, subjective assessments of caregivers and family and neuroimaging~     techniques.~      Aim. The aim of this study is to better understand how unconscious palliative sedated~     patients experience the last days of their life and to find out if they are really free of~     pain.~      Methods In this study the investigators will observe 40 patients starting with initiation of~     palliative sedation until death.~      Assessment of comfort based on behavioural observations will be related with the results from~     a NeuroSense monitor, an EEG-based brain monitor used for evaluation of the adequacy of~     anesthesia and sedation in the operating room and an ECG-based Analgesia Nociception Index~     (ANI) monitor, which informs about the comfort or discomfort condition of the organism, based~     on the parasympathetic tone (including calculation of ANI). Additionally, the researchers~     will investigate whether changes of these measures can be linked to changes in the patients'~     experience as observed by caregivers and relatives, especially in the last moments of life.~     An innovative and challenging aspect of this study is its qualitative approach, implying all~     the different types of data will be used to link objective and subjective data to achieve~     a holistic understanding of the study topics.~      The following data will be collected:~        -  assessment of pain/comfort by the patients themselves before loss of consciousness due~          to deep continuous sedation (if possible) by scoring a Visual Analogue Scale (VAS)~        -  brain function monitoring (NeuroSense monitor)~        -  monitoring of parasympathetic tone (ANI monitor)~        -  assessment by caregivers on 3 VAS scales (different scales or 3 different caregivers?)~        -  relatives' perception of the quality of the dying process on 3 VAS scales (idem)~        -  assessment by 2 trained investigators using observational scales~        -  observation: video and audio registration~   "
22444|NCT03273231|"~     Systemic inflammation caused by surgery may aggravate immunosuppression in immunocompromised~     cancer patients. The natural killer (NK) cell is a critical part of anti-tumor immunity.~     ketamine, a N-methyl-D-asparate receptor antangonist, has anti-inflammatory activity and~     opioid-sparing effect. This study investigate the effect of intraopertaive ketamine~     administration on immune function in patients undergoing laparoscopic colorectal cancer~     resection.~   "
22445|NCT03273218|"~     The aim of this study was to assess effectiveness and safety of Tiger (5Fr) vs Judkins (5Fr)~     catheters, in coronariography via the right transradial approach.~      This was a prospective, randomized, study of paralled design. Consecutive patients with acute~     coronary syndrome (ACS), eligible for coronary angiography, was randomized after successuful~     cannulation of right artery and informed consent to either Tiger or Judkins catheters.~   "
22535|NCT03272009|"~     Bile acids regulating farnesoid X receptor (FXR) interact with hepatitis B virus replication.~     EYP001a is a selective, synthetic FXR agonist under development for the treatment of~     hepatitis B.~      This Phase 1b study is designed primarily to determine the safety, tolerability,~     pharmacokinetics and pharmacodynamics of EYP001a in chronically HBV infected subjects.~   "
22446|NCT03273205|"~     Anorexia Nervosa (AN) is a serious and often chronical eating disorder characterized by an~     extreme effort for weight loss and intense fear of becoming fat despite the obvious thinness.~     The treatment is very difficult and not always effective. That´s the reason why we are~     looking for new ways of the therapeutic approach.~      Transcranial direct current stimulation (tDCS) is a neuromodulation technique, which~     modulates the neuronal excitability. According to previous research it has a potential to~     help people with Anorexia Nervosa.~      The device for the tDCS has two electrodes, an anode (the excitatory one) and a cathode (the~     inhibitory one). We put them on the skull into the different positions, in dependence on the~     fact, if we want to excite or on to inhibit the parts of the brain under the electrodes.~      There are several hypothesis how could the tDCS help in patients with AN. One of them speaks~     about the hyperactivity of the right hemisphere in Anorexia Nervosa. Therefore could the~     anodal (excitatory) tDCS over the left hemisphere and the cathodal (inhibitory one) help in~     resetting the inter-hemispheric balance.~   "
22447|NCT03273192|"~     This study aims to demonstrate pharmacokinetic (PK) similarity of biosimilar candidate~     CinnoRA® relative to adalimumab reference product (Humira®) and evaluate safety and~     tolerability of CinnoRA®, in a parallel fashion in healthy volunteers after administration of~     a single dose (40 mg) of adalimumab.~      The primary objective of this study is to demonstrate that the PK of CinnoRA® is similar to~     its originator, Humira®, as assessed by the area under the serum concentration time curve~     (AUC) from time 0 extrapolated to infinity (AUCinf) and the Cmax.~      The secondary objectives of the study are:~        -  To further compare the PK of CinnoRA® and Humira®.~        -  To assess the safety of CinnoRA®.~   "
22448|NCT03273179|"~     This is a single-center, retrospective, open-label study. This study is planned to~     investigate the accuracy of mRS and NIHSS, comparing with the accuracy of CSF pressure and~     papilledema grade in assessing cerebral venous sinus thrombosis.~   "
22449|NCT03273153|"~     This is a Phase III, multicenter, open-label, randomized study designed to evaluate the~     efficacy, safety, and pharmacokinetics of cobimetinib plus atezolizumab compared with~     pembrolizumab in treatment-naive participants with advanced BRAFV600 wild-type melanoma.~   "
22450|NCT03273140|"~     Background: The prevalence of DM is increasing across both Asian and Western countries, in~     proportion to the rising aging population. Type 2 diabetic patients are the high-risk group~     to experience diabetes-related complications that can lead to depression, poor quality of~     life and even death. In the current face-to-face diabetes counseling, the patients presented~     with weak comprehension of diabetes knowledge. There is a gap between application of~     knowledge and self-efficacy behaviors. With the increased patient acuity in the recent years,~     it has contributed to the shortage of diabetes nurse educators to meet the demands or needs~     in the outpatient endocrine clinic. Often, the patients have to wait longer for their turn~     for diabetes education, which can result in a delay in diabetes self-management. The use of~     mobile health technologies had demonstrated a positive impact on diabetes-related outcomes~     and better self-efficacy behaviors, all of which are crucial in diabetes management.~      Aims: This study is to evaluate the effectiveness of Gamification Diabetes Education Program~     (GDEP) on HbA1c values, self-efficacy, sense of coherence and quality of life among the~     poorly controlled 2 diabetic patients.~      Methods: This study adopted a randomized control trial design. Based on Cohen's power~     analysis, one hundred and forty-eight participants will be recruited through simple random~     sampling. The recruitment process includes block randomization and allocation concealment.~     Participants will either be randomized into intervention (GDEP) group or control (current~     practice) group. The self-efficacy instrument, sense of coherence scale (SOC-13), world~     health organisation quality of life scale- brief (WHOQoL-BREF) and HbA1c values assessed the~     outcomes at the same time points: point of enrollment (pre) and two post-time points at~     12-week and 24-week.~      The significance of study: GDEP would bring about awareness on diabetes management and~     contribute to existing diabetes literature. It addresses the clinical significance of~     enhancing diabetes knowledge and motivation in self-efficacy behaviors. Hence, GDEP has the~     potential to close the gap between application of knowledge to self-efficacy behaviors, which~     in turn would result in better self-efficacy, sense of coherence and quality of life. All of~     these could reduce their HbA1c values and the global health care expenditure spent on~     managing diabetes mellitus alone. The development of GDEP is a value-added and~     innovative-driven packaging to close the gap and address the limitation in the current~     literature. It serves to transform workforce and redesign patient education process for type~     2 diabetic patients.~   "
22451|NCT03273127|"~     A Phase 1 study to assess pharmacokinetics (PK) and safety of abediterol 5 μg dry powder~     inhaler (DPI) given once daily (QD) for 9 days, compared to placebo, in patients with asthma~     on inhaled corticosteroids (ICSs).~   "
22452|NCT03273114|"~     There is evidence, of a single randomized controlled trial, that CFT is better than combined~     manual therapy and motor control exercise for chronic low back pain. However, this study had~     significant methodological shortcomings regarding the failure to carry out the intention to~     treat analysis and a considerable loss of follow-up of patients. As it is, it is important to~     carry out more studies involving CFT compared to other interventions already used in clinical~     practice and to correct these methodological shortcomings. Therefore, the aim of the study is~     to assess the efficacy of Cognitive Functional Therapy in patients with chronic non specific~     low back pain.~   "
22453|NCT03273101|"~     Background: Manual lifting is a common method to train the sit-to-stand, in which repetition~     is important. Alternate training regimen by mechanical device may be opted to avoid staff~     injury.~      Objective: The purpose of the study is to investigate the repetitive mechanical training to~     improve the independence of standing up.~      Methods: A total of 38 participants were randomised into two groups. Both groups had no~     lesser than 100 repetitions or 10 minutes/day of training sessions. Berg Balance Scale (BBS),~     Modified Rivermead Mobility Index (MRMI), Sit-and-Reach test (SRT), Five-Repetition~     Sit-to-Stand Test (5XSST), Sit-to-Stand Test from the Balance Master® (SST) were assessed in~     baseline, after 5 days and 10 days of training.~   "
22454|NCT03273088|"~     This study aims to demonstrate pharmacokinetic (PK) similarity of biosimilar candidate~     Altebrel relative to etanercept reference product (Enbrel®) and evaluate safety and~     tolerability of Altebrel, in a crossover fashion in healthy male volunteers after~     administration of a single dose (25 mg) of etanercept.~      The primary objective of this study is to demonstrate that the PK of Altebrel is similar to~     its originator, Enbrel®, as assessed by the area under the serum concentration time curve~     (AUC) from time 0 extrapolated to infinity (AUCinf) and the Cmax.~      The secondary objectives of the study are:~      To further compare the PK of Altebrel and Enbrel®. To assess the safety of Altebrel.~   "
22536|NCT03271996|"~     This study wants to improve patient care affected by pilonidal sinus during and after~     surgery. Pilonidal sinus excision is a frequent procedure, despite this, there is still not~     an appropriate surgical technique because of a lack of quality comparative studies.~   "
22537|NCT03271983|"~     Generate human PK data by collecting data following the application of metronidazole~     formulations.~   "
26791|NCT03216304|"~     To evaluate if safinamide at the steady state, obtained after multiple 100 mg once a day~     administrations, has an effect on the pharmacokinetics of rosuvastatin, concomitantly~     administered as a single 20 mg dose, with respect to the pharmacokinetics of 20 mg~     rosuvastatin administered alone.~   "
22455|NCT03273075|"~     In patients with ST-elevation myocardial infarction (STEMI) undergoing percutaneous coronary~     angioplasty (PCI) P2Y12 receptor (P2Y12r) inhibition should be achieved as soon as possible.~     Resuscitated STEMI-patients receiving targeted temperature management (TTM, therapeutic~     hypothermia) after cardiac arrest, however, show deteriorated and delayed early response to~     available oral P2Y12r inhibitors. Therapeutic hypothermia attenuates the drugs' effectiveness~     by reducing its gastrointestinal absorption and metabolic activation. Acute stent thrombosis~     is 5-fold increased after angioplasty following resuscitated cardiac arrest because of~     insufficient early platelet suppression. Thus, aggressive antiplatelet strategies are needed~     to achieve optimal platelet suppression during PCI in those patients. The first intravenous~     P2Y12r inhibitor, cangrelor, has recently received marketing authorization for the acute~     treatment of STEMI. We hypothesize that add-on antiplatelet therapy with intravenous~     Cangrelor on-top of standard dual anti platelet therapy (DAPT) with Prasugrel or Ticagrelor~     is superior to standard antiplatelet therapy alone in terms of suppressing ADP-dependent~     platelet activation in resuscitated STEMI-patients receiving TTM.~   "
22456|NCT03273062|"~     This is a follow-up study for an ongoing open label trial conducted by the Sheppard~     Pratt-Lieber Research Institute utilizing the catechol-O-methyl-transferase (COMT) inhibitor~     Tolcapone to evaluate its effects on cognition and neuropsychiatric symptoms in patients with~     brain injuries (BI).~      In this study, investigators will conduct a double-blind, placebo-controlled clinical trial~     utilizing a crossover design to study the effects of two weeks of Tolcapone 200mg~     administered three times a day (total of 600mg/day) on cognitive performance. Physical,~     emotional, cognitive and social functioning will also be evaluated through participant and~     proxy report. The investigators are planning to randomize a total of 12 patients with a~     history of acquired brain injury (BI).~   "
22457|NCT03273049|"~     This project will primarily evaluate the developmental/genetic basis of biliary atresia, the~     most common cause of liver failure at birth, and which accounts of half of all liver~     transplants performed worldwide in children.~   "
22458|NCT03273036|"~     The endoscopic discectomy has rapidly developed and increased need by patients. This~     procedure is widely performed by interventional pain physicians as well as by spine surgeons~     because it requires no general anesthesia or admission to a hospital. Many studies were~     reported that corticosteroid injection can inhibit persistent postoperative pain in lumbar~     discectomy. However, data of perioperative epidural steroids after an endoscopic discectomy~     is lacking.~   "
22459|NCT03273023|"~     To compile real-world clinical outcome data for the Promus PREMIERTM Everolimus-Eluting~     Platinum Chromium Coronary Stent System (Promus PREMIERTM Stent System) in routine clinical~     practice in China.~   "
22460|NCT03273010|"~     The palatal donor site of autogenous free gingival grafts significantly influences the~     patient's morbidity. The purpose of this study was to evaluate the efficacy of cyanoacrylate~     on palatal wound healing and postoperative complaints.~   "
22461|NCT03272997|"~     The investigators aim is to asses the diagnostic power of 18F-FDG PET-CT in discriminating~     malignant from nonmalignant causes in patients with a recurrent unilateral pleural effusion~     of unknown origin.~   "
22462|NCT03272984|"~     Patients received neoadjuvant chemotherapy with locally advanced gastric caner undergo the~     enhanced recovery after surgery (ERAS) programs or the standard cares (SC) programs.~   "
22463|NCT03272971|"~     The feasibility of a RF ablation catheter to bronchoscopically ablate lung tumors, will be~     evaluated in patients already scheduled for surgical resection.~   "
22464|NCT03272958|"~     Whereas pruritus is a major symptom in bullous pemphigoid, its characteristics and its impact~     on quality of life have been little studied.~      The objective of this study is to learn more about pruritus characteristics of patients with~     bullous pemphigoid, and in consequence to better understand the pathophysiology of pruritus,~     and then to better treat pruritus in this condition.~   "
22465|NCT03272945|"~     Linked color imaging (LCI) was recently developed and uses a laser endoscopic system~     (Fujifilm Co, Tokyo, Japan) that acquires images by simultaneously using narrow-band~     short-wavelength light and white-light (WL) in an appropriate balance. LCI is a new~     image-enhancing technology that is intended to enhance slight color differences in the red~     region of the mucosa. The acquired color information is reallocated to differentiate colors~     that are similar to the mucosal color, resulting in improved performance in depicting blood~     vessels, and additional image processing that enhances color separation for red color permits~     clear visualization of red blood vessels and white pits. This modality may increase the~     detection rate of colorectal polyps by enhancing the visibility of colonic mucosal vessels.~     In addition, it has been reported that LCI increases the visibility of colorectal flat~     lesions and contributes to improvement of the detection rate for these lesions. The primary~     aim of the current study was to compare the detection rate of colorectal flat lesions of LCI~     cap-assisted colonoscopy with WL cap-assisted colonoscopy in prospective randomized trial. In~     addition, we prospectively compared LCI and WL with regard to the visibility of colorectal~     flat lesions found in this study.~   "
22466|NCT03272932|"~     This study is to assess the prevalence of Asthma COPD Overlap in subjects with diagnosed~     asthma and chronic obstructive pulmonary disease (COPD). The subsequent morbidity and~     mortality of subjects will be followed up for 3 years.~   "
22467|NCT03272919|"~     Chemotherapy induced peripheral neuropathy (CIPN) is a common side effect of many forms of~     chemotherapy having a negative impact on the quality of life for cancer survivors due to~     numbness, decreased sensation, pain (of various intensities in the extremities), gait/balance~     problems, and difficulty with fine motor skills of the hands and fingers.To date, there are~     no preventive modalities to mitigate CIPN development.When CIPN becomes intolerable, optimal~     doses of chemotherapy have to be reduced or discontinued, which may affect a patient's~     overall survival. Intraneural facilitation (INF) is a technique developed by physical~     therapists at Loma Linda University after careful study of the structure, pathophysiology and~     biomechanics of peripheral nerves. The focus of INF is restoration of circulation to an~     ischemic nerve. INF has been offered to subjects receiving treatment at LLUCC with anecdotal~     success. The purpose of this study is to evaluate INF as a treatment modality under the rigor~     of scientific inquiry to determine its effectiveness as a viable treatment option for breast~     cancer patients with CIPN.~   "
38559|NCT03061968|"~     The purpose of this study is to investigate the effects of acupressure application in very~     low birth weight premature.~   "
22469|NCT03272893|"~     The goal of this research project is to explore if levels of inflammation predict levels of~     comorbid mood disorders and treatment success in chronic pain patients. More knowledge in~     this respect will advance our understanding of chronic pain and comorbid syndromes, and~     facilitate subgroupings of patients based on the presence and/or level of low-grade~     inflammation. This research is an important step towards finding an explanation to why~     treatment effects following behavioral interventions differ across individuals, and generate~     new hypothesis regarding novel treatment approaches. The specific aims are: 1) to explore if~     baseline levels of inflammatory biomarkers predict the effects of behavioral intervention and~     2) to investigate if baseline levels of inflammatory biomarkers are associated with~     psychological co-morbidity (e.g. depression, anxiety and fatigue) in patients with chronic~     pain.~   "
22470|NCT03272880|"~     The purpose of this study is to evaluate the impact of arts-based programming on health,~     well-being, and resilience. Patients who have cancer or are the caregivers of someone with~     cancer are being asked to take part in this study.~   "
22471|NCT03272867|"~     This pilot study serves to investigate whether ProManna intake leads to any changes in~     baseline levels for oxidative stress markers. In addition, biomarker responses following~     oxidative stress challenge tests will be assessed in subjects taking ProManna versus placebo~     supplements.~   "
22472|NCT03272854|"~     Short-term (1-year) results of renal transplantation are now excellent (over 95%). Long-term~     (10-year and longer) results are, however, still disappointing. Where most research has~     focused on immunosuppression and infections, the investigators hypothesize that in renal~     transplant recipient, amongst others overweight, obesity, chronic use of immunosuppressive~     drugs and impaired renal function contribute to insulin resistance and chronic low-grade~     inflammation, which pose the renal transplant recipients at increased risk for cardiovascular~     disease, decline of function of the transplanted kidney and other complications, including~     post-transplant diabetes. This study is a biobank and cohort study which investigates this~     hypothesis.~   "
22473|NCT03272841|"~     TransplantLines is an observational cohort study in all solid transplant recipients, i.e.~     kidney, heart, lung, liver, small bowel and pancreas. In this study we will gather~     questionnaires about topics affecting transplant recipients, e.g. QoL, work and physical~     capacity. Moreover, we will collect multiple urine and blood samples for analysis.~     Additionally, we will store hair, nails and faeces from the transplant recipients. Next to~     this, we will perform physical capacity tests and cognitive tests.~   "
22474|NCT03272828|"~     The purpose of the study is to compare two different types of dental implants which will be~     used to support/retain a removable denture in the edentulous mandible. Subjects will have one~     implant placed in the midline of the mandible after which the patient's existing denture will~     be modified to fit the implant. The population of this study consists of healthy edentulous~     individuals 20-75 years of age who have complete dentures in the upper and lower arch.~   "
22475|NCT03272815|"~     This study aims to examine the safety and efficacy of the Percussion Device in detecting a~     pneumothorax in patients that have undergone thoracic surgery.~   "
22476|NCT03272802|"~     Amyotrophic Lateral Sclerosis (ALS) is a neurodegenerative disease that causes the death of~     30,000 affected individual every year. Complex nature and unknown pathogenesis of this~     disease are 2 major reasons for failure of therapeutic interventions. Edaravone is a free~     radical scavenger that slows down functional decline and prevents from disease progression in~     ALS patients. FDA newly approved this drug in these patients (2017/5/5). In this study,~     investigators aimed to assess the treatment effect of this newly approved drug in patients~     with ALS in a representative Iranian population.~   "
22477|NCT03272789|"~     Sometimes, certain patients, while the treatment comes to an end and while a remission is~     possible, present psychological and emotional difficulties. The return in a  new life  is~     lived as a factor of often unexpected stress which force the patients, from the end of the~     treatment, to reconsider their future orientation, their roles and social identities, their~     interpersonal relations, and the quality of their life.~      Often, they feel a strong feeling of isolation and a shape of social marginalization stressed~     by the fact that forgiveness lead automatically to a spacing of the stays to the hospital,~     which were for them a source of social interactions. Often incapable to deal with these~     negative emotional situations, they live profound depressive episodes known to be associated~     to a lesser survival.~      The investigators think that a support of type onco-coaching of sport- inspirated could allow~     these survivors to find a certain quality of life to see certain well-being.~      In a recent study, It was analyzed the leadership  which works  in the high-level sport in~     France. Five selectors of national teams of team sports were questioned about their~     conceptions on the best practices of management and management of the people. They grant a~     quite particular attention on the individual consideration of the athlete and the~     implementation of a relationship of trust, to the delegation of the power and the sharing~     regulated by the decision-making which strengthen the sportsman in a feeling of autonomy and~     skill, catalysts of an intrinsic motivation.~      These needs were satisfied, they give meaning to the share and get a psychological~     well-being. The satisfaction of these needs is generally made through the realization of~     purposes, results wished by an action, which can sometimes enter in contradiction with the~     satisfaction of the fundamental needs and thus damage the well-being. The role of the coach~     is to help the coached to target its purposes, to decide on a strategy to affect him and keep~     an intact motivation throughout the process. Without being therapeutic, the questioning and~     the action of the coach would allow the coached to reach gradually the satisfaction of its~     fundamental psychological needs and thus a real well-being.~      The intention is to make them benefit knowledge and expertise in the field of the coaching~     and by a logic of research inter disciplinary to set up steps of support individualized to~     propose adapted answers and assist them at best in their company on returning to the life by~     making a significant contribution with the patients to help them to find of the autonomy in~     their own decision-making, to find their social identity (refusal and discharge of positive~     or negative discrimination), to accompany the therapeutic education of the patient towards a~     stake in social reeducation and finally, to highlight and to strengthen its interests and~     social concerns.~      In terms of public health, this approach, facilitating the transition of the treatment in the~     complete remission, could be subjected and so improve the quality of the services of support~     proposed until then.~      If the hypotheses of research see each other confirmed, this device coaching of~     sport-inspired of the patients in remission could then be transferable in other oncologic~     fields.~   "
22478|NCT03272776|"~     The study was designed to evaluate the success rate, time of insertion, sealing efficacy and~     security of the Protector Laryngeal Mask, a new second generation disposable supraglottic~     airway device, in patients undergoing elective surgery.~   "
22479|NCT03272750|"~     Controlled, randomized, double blind study, for the evaluation of tolerance and trichological~     efficacy of a food supplement: Bioscalin® new formulation versus reference formulation~     currently on the market and placebo~   "
22480|NCT03272737|"~     The purpose of the present study is to evaluate the acute and chronic effect of low intensity~     strength training with or without moderate blood flow restriction on muscle vasodilation and~     arterial stiffness in elders with low gait speed. In addition, the responses of prothrombotic~     factors in blood coagulation, the impact on heart rate and arterial pressure will be~     assessed.~   "
22481|NCT03272724|"~     The objective of this observatory is to provide a national database of infective~     endocarditis, informed by all volunteer centers, using a standardized case report forms.~      Such an observatory will describe the clinical profile, microbiological, therapeutic and~     evolving of infective endocarditis (IE); analyze the risk factors for the disease and its~     prognosis factors of evolution; describe management practices; evaluate and compare in the~     real drug treatment strategies (including antibiotics) and surgical.~   "
22482|NCT03272711|"~     The purpose of this research study is to examine the potential benefits of vortioxetine in~     combination with at-home computerized cognitive training program to improve cognition, such~     as memory, attention, and concentration. This study will compare the effectiveness of~     vortioxetine plus cognitive training versus placebo plus cognitive training.~   "
22483|NCT03272698|"~     To determine if an high intensity ketamine with ECT rescue (HIKER) approach for treatment~     resistant depression will: 1) reduce patient suffering by hastening disease remission, 2)~     have fewer side effects, 3) reduce the need for ECT, and 4) be preferred by most patients.~     Half of participants will be randomized to the HIKER arm and receive high intensity ketamine~     treatment for eight consecutive days, and the other half will be assigned to the ECT with~     ketamine anesthesia (EAST) arm and receive 8 ECT treatments (2-3 treatment/week)~   "
22484|NCT03272685|"~     This project will examine the impact of very low nicotine content (VLNC) cigarettes in a~     complex tobacco and nicotine product marketplace. We will compare the number of cigarettes~     smoked, use of alternative nicotine-containing products, biomarkers of toxicant exposure and~     days abstinence from cigarettes in an experimental marketplace that contains VLNC cigarettes~     versus normal nicotine content (NNC) cigarettes.~   "
22486|NCT03272659|"~     This will be a pilot study involving 5 patients diagnosed with colorectal carcinoma and~     treated with pre-operative chemotherapy and external beam radiation therapy at the Jewish~     General Hospital, whom will very soon undergo surgery. Participants will be sensitized by the~     instillation of a 250 mL enema containing 1.6 mmol of HAL. The enema will be administered~     with a plastic tube with an inflatable blocking balloon to prevent leakage of the enema.~     Fluorescence sigmoidoscopy will be performed with white light then blue excitation light~     after retention of the enema for 60 minutes, followed by a rest time of up to 30 minutes~     before rectoscopy. Red fluorescence should be induced by illumination with blue light.~     Pictures with and without fluorescence will be taken. The patients will undergo a colectomy~     (partial or complete) within the next 2-3 days and the surgical specimens will be collected~     for further fluorescence microscopy studies and pathological correlation of fluoresce with~     malignant pathology/histology as the gold standard. The total concentration of porphyrins in~     the patients' urine and serum will be recorded before sensitization, immediately after~     sensitization (instillation of the enema), and approximately 24 hours after sensitization.~     The patients' pre-and-post operative liver function tests will be measured. Adverse events~     will be reported by direct questioning of all patients with regards to photosensitivity and~     gastrointestinal symptoms (nausea, vomiting), and by measuring blood pressure and heart rate.~     Our objectives and endpoints are: 1) to determine if fluorescence with photodynamic~     diagnostics is selective for colorectal cancer, 2) to determine if photodynamic diagnostics~     has the potential to improve the detection of malignant cell after neoadjuvant chemotherapy~     and radiation, and 3) to determine if photodynamic diagnostics can provide an accurate~     depiction of the extent of disease burden not visible with normal white light sigmoidoscopy~     to the naked human eye.~   "
22487|NCT03272646|"~     To investigate the prognostic performance of the Naples Prognostic Score in gastric cancer~     patients undergoing surgery~   "
22488|NCT03272633|"~     This pilot clinical trial studies the side effects of irradiated donor cells following stem~     cell transplant in controlling cancer in patients with hematologic malignancies. Transfusion~     of irradiated donor cells (immune cells) from relatives may cause the patient's cancer to~     decrease in size and may help control cancer in patients receiving a stem cell transplant.~   "
22489|NCT03272620|"~     The results of this study could imply that a atrial fibrillation registry, as a tool for~     structured diagnosis and therapy in patients with atrial fibrillation, may improve patient~     care for this rapidly growing population.~   "
22490|NCT03272607|"~     Reducing medications and associated side effects in older adults: an electronic~     hospital-based intervention~   "
22491|NCT03272594|"~     Background: Even the healthiest infants undergo painful procedures as part of universal~     medical care. Untreated early pain is associated with heightened pain response during later~     procedures in infancy and alteration in response to pain in childhood. Oral sucrose is~     currently considered the standard of care for acute pain relief in infants. Compelling~     evidence from 57 randomized controlled trials suggests that oral sucrose reduces~     bio-behavioral pain response. However, recent data examining the influence of oral sucrose on~     pain-specific brain activity measured using electroencephalogram (EEG) questions the efficacy~     of this intervention for reducing pain in the infant brain. Evidence supports the~     effectiveness of breastfeeding as a pain relieving intervention, however, no studies to date~     have examined the effect of breastfeeding on pain-specific activity in the newborn brain.~      Aims: The primary aim of this study is to examine the influence of breastfeeding in~     comparison to oral sucrose on pain-specific activity in the newborn brain during a heel~     lance. The secondary aim will be to determine if there is convergence among outcome measures~     in either of the intervention conditions.~      Methods: Utilizing a single blind, randomized controlled trial design, 126 healthy term~     infants will be recruited within the first two days of life. Infants will be randomized to~     have a medically indicated heel lance completed in one of two possible conditions: 1)~     breastfeeding (n = 63) or 2) sucrose in an infant cot (n = 63). Infants will not be eligible~     for study participation if they show signs of lower limb tissue damage, have had previous~     surgery or intraventricular hemorrhage, are born to opioid using mothers or with significant~     genetic disorders, are unable to breastfeed, or have contraindications to sucrose~     administration. Pain-specific brain activity will be recorded on EEG for the duration of the~     blood collection. Infant facial response will be video recorded, and heart rate and oxygen~     saturation will be measured for calculation of Premature Infant Pain Profile-Revised (PIPP-R)~     Score, a reliable and valid bio-behavioral measure of pain in infants' 26-44 weeks~     gestational age. For infants randomized to the breastfeeding condition, data collection will~     begin with recording of a one-minute baseline (BL1). Following this, a non-painful control~     stimulus will be applied to the infant's foot to capture a baseline response on EEG to a~     non-painful event. The infant will then be transferred to the mother and active breastfeeding~     will be facilitated. A second baseline (BL2) will be recorded prior to heel lance. Pain~     response will be recorded from the initiation of the heel lance until procedure completion.~     In the sucrose condition, all monitoring will take place while the infant is in a cot~     (considered standard of care). Procedures will be consistent with those outlined above with~     the exception of administration of 24% oral sucrose two minutes prior to the heel lance.~     Analysis and inference will be calculated based on the intention-to-treat principle. Data~     from the EEG recording will be grouped into basic waveforms using principal component~     analysis. Two one-way analysis of variances will be used to assess the effect of stimulation~     type (non-painful control, painful heel lance) and treatment (24% oral sucrose,~     breastfeeding) on the principal components. To assess for the effect of treatment on PIPP-R~     score, group means will be compared using unpaired Student's t-tests.~      Hypotheses: Infants in the breastfeeding condition will demonstrate both lower pain-specific~     brain response and lower bio-behavioral pain scores than infants in the sucrose condition.~      Significance: This will be the first study to examine the effect of breastfeeding on~     pain-specific brain response in infants. In light of the negative consequences of unmanaged~     pain in infants, it is imperative that effective pain relieving interventions are utilized.~     Given recent evidence questioning the analgesic properties of sucrose, findings will have~     important implications for informing optimal pain management practices in infants.~   "
22492|NCT03272581|"~     Basketball has gained worldwide popularity and fascinated players and spectators with its~     dynamic characteristics as a team sport. This kind of sport is multifaceted that requires~     well-developed physical ﬁtness to be played successfully. Many authors have suggested that~     strength, power, agility, and speed are important performance related physical components for~     elite basketball players. The physical components require that fitness and conditioning~     attributes of basketball players are well developed to negate the limiting aspect of sport~     performance. Moreover, functional training is becoming increasingly popular within the~     fitness industry and has been considered to be a better alternative than traditional training~     methods for improving various measures of performance. The purpose of this study was to~     determine whether functional training has effects on performance and related various physical~     components of basketball players.~   "
22493|NCT03272568|"~     The purpose of this feasibility study is to find out if two clotting factor products,~     Eloctate [hemophilia A] and Alprolix [hemophilia B], can reduce the amount of menstrual~     bleeding in female hemophilia A and B carriers (14 years of age or older) who have severe or~     heavy bleeding. These products are FDA-approved for use in males with hemophilia A and B to~     prevent and treat bleeding. They are not approved specifically to reduce menstrual bleeding,~     but may be useful for this purpose. Both products have an extended half life which means~     they circulate in the body longer than other FVIII or FIX products. The study team will~     gather additional information about the safety of these drugs and how well they work. The~     results of this feasibility study will provide information for an upcoming larger study.~   "
22494|NCT03272555|"~     The purpose of this study is to explore the efficacy and feasibility of an integrated,~     prescriptive, and trackable wellness intervention combining five wellness elements including~     exercise, mindfulness, sleep, social connectedness, and nutrition in First Year Beloit~     College students self-selected into a wellness focused first year initiative.~   "
22495|NCT03272542|"~     Gastric bypass surgery is a highly effective treatment for obesity, but it has negative~     effects on skeletal health, due in part to a dramatic decline in intestinal calcium~     absorption capacity. Animal and human studies suggest that non-digestible fibers termed~     prebiotics, such as soluble corn fiber (SCF), augment calcium absorption in the lower~     intestine as they act as substrates for beneficial gut microbiota. This is a pilot randomized~     controlled trial of the effects of SCF vs. placebo on intestinal calcium absorption, bone~     turnover marker levels, and the gut microbiome in postmenopausal women who have previously~     undergone gastric bypass surgery.~   "
22496|NCT03272529|"~     Surgical simulation provides opportunities for surgeons to practice specific skills, prior to~     performing complex tasks on patients, with the goal of reducing potential errors and~     providing a safer procedure for the patient. The investigators will use a novel approach to~     simulation (patient-specific rehearsals) i.e., practice a short time prior to the live event~     that uses gel models of organs created by a 3D printer, and that are specific to each patient~     versus models that represent an ideal training model. The investigators' overarching goals~     are to improve patient outcomes by developing the best platform for surgeons to efficiently~     enhance performance prior to live surgery.~   "
22497|NCT03272516|"~     This study is done to evaluate the effects of Mindfulness Based Cognitive Therapy (MBCT) for~     primary care patients that have mild to moderate symptoms of depression and anxiety. Half of~     the study participants will receive treatment as usual (TAU), and the other half will receive~     TAU plus MBCT. The investigators will be comparing changes in symptoms of depression and~     anxiety between the groups, and hypothesize that the TAU plus MBCT group will have~     significantly lower symptoms of depression and anxiety compared to TAU group~     post-intervention~   "
22548|NCT03271840|"~     Primary Ciliary Dyskinesia (PCD) is a rare disease, which means that any single PCD center~     has experience with a limited number of patients. PCD Registry is the collection of data~     about PCD from many centers and countries who treat children with PCD. Collecting data about~     PCD increase the knowledge on PCD, better describe the course of the disease, and help to~     better understand the progression of the disease and be used to develop new treatments.~      In the PCD registry of Alberta, important information about PCD such as time of diagnosis,~     symptoms, and tests which led to the diagnosis, state of health at diagnosis, the progression~     of lung function, the occurrence of severe infections, tests and treatments data will be~     collected from the patients' medical records.~   "
22498|NCT03272503|"~     This study will look at whether Pimozide may help to slow the progression of Amyotrophic~     Lateral Sclerosis.~      100 people from several Canadian centres with ALS who have provided their consent will be~     randomly assigned into one of 2 groups. The first group will receive a dose of up to 4mg of~     Pimozide per day and the second group will receive placebo (lactose tablets). Subjects will~     be assigned randomly (like by a flip of a coin) to receive either Pimozide 4 mg per day or~     placebo tablets. There will be a fifty-fifty chance of receiving Pimozide or placebo.~      Participants will be on study medication up to 22 weeks, and on study up to 26 weeks. There~     are 8 clinic visits and 1 phone visit over the course of the Treatment Phase of the study.~     The second phase which is Observational, is optional with follow-up for up to 5 years from~     the end of the Treatment Phase.~   "
22499|NCT03272490|"~     20 patients with distal humeral fractures (AO 13-A1 - AO 13-C3) were included in the current~     study since 2014. After completing the randomization plan, patients were distributed into two~     groups for different variable angle locking plates (DePuy Synthes VA-LCP vs. Medartis Aptus~     Elbow). Clinical and radiological follow-ups were conducted 6 weeks, 12 weeks, 6 months and~     12 months after the operation.~   "
22500|NCT03272477|"~     This is a prospective, phase IIa, multicenter, randomized, open-label study comparing a~     pre-surgical combination of trastuzumab and pertuzumab with concurrent weekly paclitaxel~     chemotherapy or endocrine therapy given for 12 weeks with a quality of life assessment for 40~     additional weeks in patients with operable HER2+/HR+ breast cancer.~   "
22501|NCT03272464|"~     This research study is studying a combination of drugs as a possible treatment for~     BRAF-mutant melanoma.~      The drugs involved in this study are:~        -  Itacitinib (INCB039110)~        -  Dabrafenib~        -  Trametinib~   "
22502|NCT03272451|"~     No consensus exists about which coronary artery should be firstly catheterized in primary~     percutaneous coronary intervention (PCI). The aim of the present study was to compare~     door-to-balloon time (D2B) of ECG guided immediate infarct-related artery (IRA) PCI with~     traditional complete coronary angiography followed by PCI for the treatment of ST segment~     elevation myocardial infarction (STEMI) patients. Primary endpoint is door to device (D2D)~     time. Secondary end-points are: puncture to device (P2D) time,first medical contact to device~     (FMC2D) time,incidence of radial artery spasm and occlusion, contrast amount, fluoroscopy~     time, cumulative air kerma(CAK) and dose area product(DAP).~   "
22503|NCT03272438|"~     While people commonly understand that regular physical exercise conveys many health benefits,~     only 20% of U.S. adults take regular exercise and they have difficulty maintaining new~     healthy behaviors. The goal of this study is to use a planning intervention to help establish~     and maintain a daily step regimen in working midlife adults. The investigators will ask~     participants to plan when, where, and how to act on a daily walking goal in conjunction with~     a scheduling intervention to increase the chances that they will maintain this new regimen.~     The effectiveness of three different scheduling interventions will be compared.~   "
22504|NCT03272425|"~     To assess the bioequivalence between lesinurad/allopurinol 200/300 FDC tablets and~     coadministered lesinurad and allopurinol tablets in the fasted state based on the~     pharmacokinetic (PK) evaluation of lesinurad and allopurinol in healthy adult subjects.~   "
22505|NCT03272412|"~     This study aims to analyze whether serum Progsterone levels on the day of Embryo Transfer are~     related with Ongoing Pregnancy rate in artificial endometrial preparation cycles with~     intravaginal micronized progesterone.~   "
22506|NCT03272399|"~     The purpose of this multi-site study is to evaluate the efficacy of a high omega-3/low~     omega-6 dietary intervention (the H3-L6 Diet) vs. a Control Diet in reducing headache pain~     and improving function in soldiers, veterans and military healthcare beneficiaries with~     post-traumatic headache (PTH). In addition, the study will examine the effects of the diet~     interventions on anti-nociceptive and pro-nociceptive lipid mediators derived from omega-3~     and omega-6 fatty acids.~   "
22507|NCT03272386|"~     The purpose of this study is to determine the best verbal instruction to obtain a PFMC and to~     evaluate the understanding and acceptability of the proposed instructions.~   "
22508|NCT03272373|"~     The objective of this study is to evaluate clinical performance for the commercially~     available NexGen TM Monoblock Tibia and NexGen TM Modular Tibia used in primary cementless~     tibia total knee arthroplasty.~   "
22509|NCT03272360|"~     This is a prospective, Single time point, discovery study intending to identify biomarkers~     that can differentiate endometriosis from other underlying reasons for pelvic pain. Patients~     undergoing laparoscopy for evaluation of chronic pelvic pain or elective tubal ligation will~     be enrolled for collection of tissue samples at the time of laparoscopy.~   "
22510|NCT03272347|"~     This study will evaluate the safety, tolerability, antiretroviral activity, and~     pharmacokinetics of 3 doses of MK-8591 in combination with doravirine (DOR) and lamivudine~     (3TC) administered to antiretroviral treatment-naïve adult participants with human~     immunodeficiency virus type 1 (HIV-1) infection.~   "
22511|NCT03272334|"~     This proposal uses HER2Bi armed activated T-cells (HER2 BATs) to target breast cancer in~     combination with pembrolizumab (PBZ) in women with metastatic breast cancer (MBC). Phase I~     will determine a safe dose of the combination of PBZ and HER2 BATs in 3 to 18 patients. In~     the phase II portion, an additional 12 patients will be treated at the selected dose to~     further evaluate the safety and preliminary efficacy.~      Study treatment includes a combination of 8 infusions of BATs using a previously established~     schedule and one to three infusions of PBZ (200 mg per dose). PBZ will be added to 8~     infusions of BATs in 3 schedules: #1) after the 8th BATs infusion; #2) after the 4th and 8th~     BATs infusions; and then, #3) before the 1st and after the 4th and 8th BATs infusions.~   "
22581|NCT03271411|"~     This is an extension of a randomized clinical trial comparing eye movement desensitization~     and reprocessing (EMDR) to progressive counting (PC) for volunteers from the community who~     are distressed by the memory of a motor vehicle accident. The purpose of this extension is to~     add Phil Manfield's recently developed Flash technique as a precursor to both EMDR and PC, to~     see a) if that has any impact on participant retention, treatment effectiveness, or treatment~     efficiency; and b) if such impact is equivalent with EMDR and PC.~   "
24802|NCT03242369|"~     Polyethylene glycol is the gold standard of bowel preparation for colonoscopy. The most~     important disadvantage is high volume of this preparation. Sulphate based solution (SBS), low~     volume PEG + ascorbic acid and solution of magnesium citric acid and sodium picosulfate could~     be suitable substitution of polyethylene glycol.~   "
22512|NCT03272321|"~     Previous research has indicated that direct eye gaze compared to averted gaze, elicits a~     higher skin conductance response (SCR), and a more pronounced left frontal cortex activity~     than right frontal cortex activity (resulting in positive asymmetry scores). On a behavioral~     level, participants tend to look shorter at live faces with a direct gaze as compared to~     averted gaze (Akechi et al., 2013). Further, subjective evaluations showed that a direct gaze~     is rated more arousing and less pleasant than an averted gaze (Akechi et al., 2013; Hietanen,~     Leppänen, Peltola, Linna-aho, & Ruuhiala, 2008).~      Importantly, oxytocin administration increases the number of fixations and to looking time~     towards the eye region during live social interaction. Further, oxytocin has been shown to~     influence SCR and heart rate variability. Therefore, it is conceivable that oxytocin will not~     only influence the gaze duration of the participant, but also the physiological and~     neurological responses elicited by direct eye gaze.~      In this study, the investigators will investigate whether oxytocin modulates the behavioural~     (eye gaze and subjective ratings), neurological (EEG) and physiological (skin conductance,~     heart rate and respiration) responses elicited by direct gaze.~   "
22513|NCT03272295|"~     This study will compare nicotine delivery and smoking behaviour in healthy subjects using~     several combustible cigarette prototypes containing different ingredients which are commonly~     used in the European Union.~   "
22514|NCT03272282|"~     Using Paperless partograph management of labour as simple tool to prevent obstructed labour~     or prolonged labour or its complications at the mother or her fetus~   "
22515|NCT03272269|"~     This clinical study will evaluate the safety of an innovative approach expected to be~     disease-modifying by stopping the auto-immune-mediated destruction of islet β-cells in the~     pancreas. Three doses of the investigational product will be tested in successive cohorts.~     Although safety is the first objective of this study, we will gather efficacy data and~     perform a set of immunological tests to further understand the mechanism of action of this~     new approach in young adults with recent onset type 1 diabetes.~   "
22516|NCT03272256|"~     The main purpose of first-in-human IM156 study is to evaluate the safety and tolerability,~     and to determine the maximum tolerated dose and recommended phase 2 dose of IM156.~   "
22517|NCT03272243|"~     A prospective study included 91 patients, who had single level thoracolumbar fracture with~     Cobb's angle ≤ 25⁰, underwent posterior fixation. Forty four patients underwent short segment~     fixation with screws into the index level, and 47 patients underwent long segment fixation~     with skipped index level. The angle of correction, pain, and neurological state were~     regularly assessed~   "
22518|NCT03272230|"~     Apathy can be defined as a quantitative reduction of voluntary or goal-directed behavior.~      So, the investigators propose a behavioral approach for assessing apathy, to obtain a~     quantifiable and objective signature of reduced goal-directed behavior by directly observing~     a patient in a real-life situation.~      ECOCAPTURE consists of a multi-step scenario in a functional exploration platform equipped~     with data acquisition system based on video and sensors that track a participant's behavior.~      The primary objective of this trial is to create a diagnostic tool for apathy, based on the~     video and sensors metrics.~      A secondary objective of this trial is to validate a new experimental task (ICM_APATHY_TASKS)~     to test independently three main presumed mechanisms of apathy (motivation, cognitive inertia~     and coupling between motivation and action).~      Another secondary objective aims to specify the pathophysiological mechanisms of apathy,~     corresponding to cognitive and behavioral processes, neural bases and neurohormonal~     mechanisms. The definition of pathophysiological mechanisms will allow the classification of~     apathetic patients (or several forms of apathy) and indicate which mechanism (s) best~     explains the apathy in a given patient.~   "
22519|NCT03272217|"~     This is a randomized open-label phase II study assessing the activity of bevacizumab combined~     with atezolizumab compared to atezolizumab alone in metastatic urothelial carcinoma patients~     who are ineligible for cisplatin-based therapy.~   "
22520|NCT03272204|"~     This research study seeks to find if there is a connection between the presence of pubic hair~     and the type of bacteria that live in the vagina and bladder.~   "
22521|NCT03272191|"~     The intent of this clinical study is to answer the questions: 1) Is the proposed treatment~     safe? and 2) Is treatment effective in improving cardiac function and clinical outcomes?~   "
22522|NCT03272178|"~     The purpose of this study is to determine implant design and determine if method of fixation~     cemented versus cementless results in different bone loss patterns. The investigators also~     want to determine if clinical outcomes correlate with bone density changes.~   "
22523|NCT03272165|"~     This is a single-centre study of single ascending intravenous doses of MEDI1341 or placebo in~     up to 48 healthy volunteers, aged 18 to 80 years.~      The study will include up to 5 planned cohorts; each cohort will comprise 8 subjects. An~     optional sixth cohort of 8 subjects may be studied.~      Each subject will receive a single 60 minute intravenous infusion of MEDI1341 or placebo and~     will undergo scheduled assessments over a period of 13 weeks.~      The main aim of the study is to assess the safety and tolerability of single doses of~     MEDI1341 in Healthy Volunteers.~   "
22524|NCT03272152|"~     Previous studies have indicated that abnormal DNA methylation frequently occurs in the mucosa~     in Crohn's disease. Comprehensive DNA methylation profiling of the inflamed and non-inflamed~     ileal mucosa of patients with Crohn's disease was performed. Genome-wide DNA methylation was~     determined using the Illumina HumanMethylation 850k BeadChip.~   "
22525|NCT03272139|"~     Sparing the phrenic nerve by administering ultrasound-guided low volume superior trunk block~     (STB) and interscalene block (ISB) for arthroscopic shoulder surgery (labral repair,~     stabilization, rotator cuff repair).~   "
22582|NCT03271398|"~     This is an internal treatment evaluation to determine whether eye movement desensitization~     and reprocessing (EMDR) or progressive counting (PC) should become the preferred trauma~     treatment for the investigator's clients. The investigator is using routine/existing in-house~     measures and case files to track symptom reduction, trauma treatment time, rate of treatment~     switching (from EMDR to PC or vice versa), and rate of trauma treatment refusal. This is~     retrospective as well as prospective archival research.~   "
24876|NCT03241394|"~     Obesity is associated with a chronic low-grade inflammation characterized by macrophage~     infiltration in adipose tissue that induces insulin resistance and the appearance of~     metabolic syndrome (MS). The aim of the study was the investigation of whether circulating~     monocyte subsets are differentially regulated in MS.~   "
22526|NCT03272126|"~     Vitamin D is a hormone with effects not only on the skeleton, but on most tissues in the~     body. Lack of vitamin D is associated with cardio-vascular disease (CVD), type 2 diabetes,~     cancer, infectious and immunological diseases, as well as risk factors for these diseases.~     However, intervention studies with vitamin D have been inconclusive regarding diseases and~     risk factors. This could be due to inclusion of subjects already vitamin D sufficient, and~     short and underpowered studies. In addition, there are indications that the dosing regimens~     may be important, so that daily doses with vitamin D are more efficient than intermittent~     doses, which so far have been generally used. This could be related to the concentration of~     circulating and thereby intracellular vitamin D concentrations, which probably is dependent~     on daily vitamin D doses. This will be tested in the present study where 60 subjects will be~     randomized to vitamin D 160 000 once, vitamin D 4000 IU/day, or placebo for four weeks. The~     primary endpoints will be effects on serum hepcidin and plasma cathelicidin after 4 weeks,~     with effects on serum PTH, RNA expression and microRNA in peripheral blood, telomerase~     activity in peripheral blood mononuclear cells and the ration between serum 1,25(OH)2D and~     24,25(OH)2D as secondary endpoints.~   "
22527|NCT03272113|"~     The aim of this study is to investigate the feasibility and likelihood of success of a~     narrative and image-based intervention, administered via text messages, for smoking cessation~     in pregnant women, prior to undertaking a large scale trial of its effectiveness. A~     feasibility and pilot trial will be undertaking involving 70 pregnant women who smoke in two~     NHS Boards.~   "
22528|NCT03272100|"~     It is assumed that the reduction of the flap dimension could provide a reduction of surgical~     time, post surgical complications and patient's discomfort when compared with the traditional~     surgical approach.~   "
22529|NCT03272087|"~     Recurrent unilateral, non-infectious pleural exudate is suspicious for primary or secondary~     pleural malignancy. Both conditions are associated with 5-year survival of 10%. Work-up is~     difficult, as the pleural surface is large and <33% of pleural malignancies shed malignant~     cells to the pleural fluid. Even so, additional tissue biopsies are needed for establishing~     mutation status for targeted therapies.~      Optimal imaging to guide tissue sampling is pivotal. PET-CT has higher sensitivity than~     conventional CT for detecting malignant lesions >10mm. However, no randomised trial has~     investigated differences in diagnostic accuracy, time-to-diagnosis, or economics. Falsely~     PET-positive lesions in e.g. colon, however, lead to more derived tests than do CT alone.~      Gold standard for pleural tissue sampling is the surgical (VATS) thoracoscopy, allowing~     direct visual guiding of tissue sampling from all pleural surfaces. Yet, globally the medical~     (pleuroscopy) thoracoscopy is more widely used: cheaper, outpatient procedure, but allows~     only sampling from the parietal pleura. To date, no randomised studies have compared medical~     and surgical thoracoscopy concerning diagnostic hit rates, adverse events, or economics.~      Investigators will perform two randomized studies to investigate whether~        1. PET/CT is comparable to CT alone~        2. VATS is comparable to pleuroscopy concerning hit rate, total investigations performed,~          time-to-diagnosis.~   "
22530|NCT03272074|"~     The intent of this study is to examine the extent to which daily incorporation of egg into a~     diet improves glycemic control, insulin sensitivity, lipid profiles, and body composition in~     overweight and obese adults with pre- and type II-diabetes. The hypothesis of this study is~     that the daily incorporation of one large egg into a diet for 12 weeks will exert positive~     effects on factors associated with glycemic control and insulin sensitivity in overweight and~     obese adults with pre- and type II-diabetes through improvements in body weight, body~     composition, and lipid metabolism.~   "
22531|NCT03272061|"~     Cognitive performance is negatively related to an impaired glucose metabolism, possibly due~     to impairments in brain vascular function. Supported by the statement from the American Heart~     and Stroke Association that physical exercise is one of the most effective strategies to~     protect against cognitive decline, we now hypothesize that exercise-induced changes in~     glucose metabolism cause beneficial effects on brain vascular function thereby improving~     cognitive performance. The primary objective of this intervention study is thus to evaluate~     in sedentary elderly men the effect of a 8-week aerobic-based exercise program on cerebral~     blood flow, as quantified by the non-invasive gold standard magnetic resonance imaging (MRI)~     perfusion method Arterial Spin Labeling (ASL). Cerebral blood flow is a robust and sensitive~     physiological marker of brain vascular function. Secondary objectives are to examine effects~     on glucose metabolism using the oral glucose tolerance test and cognitive performance as~     assessed with a neurophysiological test battery.~   "
22532|NCT03272048|"~     Each year in the United States (U.S.), over 40,000 individuals die by suicide, and~     approximately half of these deaths occur by intentional, self-inflicted gunshot wounds. Given~     these staggering statistics, efforts to minimize individuals' access to firearms during~     at-risk periods has been identified as a critical if fraught suicide prevention strategy.~     Among individuals at risk for suicide who present to clinical settings, a crucial component~     of the clinical management of suicide risk is to ask about firearm ownership/access and~     counsel on firearm safety (e.g., encourage an at-risk person to transfer the firearm to a~     loved one until risk abates). Despite the clinical, ethical, and in some cases legal mandate~     of this intervention, a substantial proportion of clinicians are woefully undertrained and~     therefore unprepared to manage suicide risk and appropriately deliver counseling on firearm~     safety. Clinical and empirical evidence suggests that even among patients identified to be at~     increased risk for suicide, few clinicians ask about firearms or provide counseling on~     firearm safety. One key reason for this fissure between recommendations and actual~     implementation of recommendations is that strategies for discussing firearm safety in a way~     that is impactful and yields patient adherence to recommendations have yet to be established.~      One common approach to attempt to garner pro-health behavior change is the use of fear~     appeals; however, research on the utility of this approach across non-firearm-related health~     interventions has been equivocal. Given the cultural importance placed on firearms in the~     U.S., the investigators contend that fear-based approaches to lethal means counseling may be~     counter-productive by creating defensive avoidance, thereby detracting from the purpose of~     counseling on firearm safety (i.e., patient safety).~      Further, patient adherence to recommendations to limit access to a firearm during at-risk~     periods may be increased when clinicians emphasize that limits on firearm access will decline~     when suicide risk abates (i.e., limits on firearm access will likely not be permanent).~     However, research has yet to determine if varying the level of fear messaging and/or emphasis~     on temporariness is actually useful and acceptable.~      To address this gap, the investigators will randomly assign participants to one of four~     experimental conditions: (1) low-fear/not-temporary; (2) low-fear/temporary; (3)~     high-fear/not-temporary; and (4) high-fear/temporary. Participants include undergraduate~     students who are vulnerable to suicide and reported owning or previously owning a firearm,~     reported access to a firearm, or reported possibly obtaining a firearm in the future. The~     investigators hypothesized that individuals randomly assigned to the low-fear/temporary group~     will (1) report greater intentions to adhere to recommendations to limit access to firearms~     during at-risk periods than the other groups at both post-intervention and one-month~     follow-up; (2) report greater actual adherence to recommendations at one-month follow-up; and~     (3) rate the lethal means counseling session as more acceptable than the other groups.~     Exploratory aims examined if the effects differed for individuals reporting actual current~     firearm ownership or access, membership in the National Rifle Association (NRA) or a similar~     organization, political affiliation, political ideology, greater personal importance of the~     Second Amendment, or severity of suicidal symptoms. Findings have the potential to inform~     clinical and public health approaches to limit at-risk individuals' access to firearms for~     safety purposes.~   "
22533|NCT03272035|"~     Very few studies are dealing with the way general practitioners feel the death of their~     patients. Main studies about that subject are qualitative. It needs quantitative studies to~     analyse how is felt general practitioners' patients' death. This is an epidemiologic~     quantitative cross-sectional study. The Studied population is the whole of the general~     practitioners of the region Nouvelle-Aquitaine. The primary endpoint is the percentage of the~     general practitioners which have hard time living with their patients' death. The secondary~     endpoints are to evaluate the general practitioners' help needing after their patients'~     death, to evaluate the personal and professional impact of the patient's death, the~     percentage of general practitioners using chemical aid after their patients' death and to~     determinate the existence of support facilities to help general practitioners to stand~     patients' death. The results of that study could help general practitioners to improve their~     medical practice in the patient's death situation.~   "
22534|NCT03272022|"~     An adequate micronutrient status during fetal life and infancy is important for optimal~     development. Dietary practices during pregnancy, lactation and infancy vary among populations~     and there is today no clear agreement on what constitutes the best diet, including~     micronutrient supplementation, during this period. There is consequently no clear agreement~     on what constitutes an optimal biochemical micronutrient status in mothers and infants. Due~     to substantial physiological changes in plasma volume, hormones, transport proteins and organ~     function during these periods, the ordinary reference levels or cut off levels used for~     biochemical assessment of micronutrient status are unsuited to these groups of patients.~      The objective of the study is to establish cut off levels for important vitamins and trace~     elements during pregnancy, lactation and infancy in order to ensure an optimal infant~     neurodevelopment and to study how micronutrient status influence the immunosystem.~   "
22538|NCT03271970|"~     The purpose of this study is to identify factors that may contribute to conductive hearing~     loss. Conductive hearing loss is a type that is due to a problem with the outer or middle~     ear. Because of this, sound does not travel through the ear normally. Perforated tympanic~     membranes of study patients will be photographed during the patient's routine visit using a~     digital otoscope. These pictures will be used to analyze perforation size as an absolute~     value as well as a percentage of the tympanic membrane. Audiometric results and CT scans of~     temporal bone (reports and images) collected as standard of care will be evaluated. Images of~     CT scans will be imported into a medical imaging software for creation of anatomically~     realistic 3D models of the middle ear and mastoid air space. Structural analysis on each 3D~     model will be conducted and analyzed, the volume of middle ear and mastoid air spaces will be~     recorded, and data points will be correlated with perforation size and location to audiogram~     results.~   "
22539|NCT03271957|"~     Is part of routine obstetric care to attempt a manual rotation in all fetus that are in a~     persistent OP at delivery. Nevertheless, little is known about the success of this~     intervention or about the relation of some ultrasound measures with the outcome.~   "
22540|NCT03271944|"~     To assess the feasibility and efficacy of the CO2 fractional handpiece in the treatment of~     vulvovaginal atrophy (VVA) in post-menopausal women and its effect on the patient~     VHIS(vaginal health index core). The primary endpoint is to assess the change in the vaginal~     dryness by means of a visual analogic scale (10 cm VAS).~   "
22541|NCT03271931|"~     Cardiovascular (CV) events are the leading cause of mortality in the United States. Statins~     have been demonstrated to be an effective tool for reducing CV events and mortality, but~     statins are often either not prescribed or under-prescribed for patients that meet~     evidence-based guidelines. In this study, we will evaluate a health system initiative using~     active choice prompts in the electronic health record to prompt cardiologists to prescribe~     evidence-based statin therapy. In partnership with the health system, this will be conducted~     as a randomized, controlled trial to evaluate its effect.~   "
22542|NCT03271918|"~     Clinically nonfunctioning pituitary adenoma remains the only pituitary tumor subtype for~     which no effective medical therapy is available or recommended. We will evaluate the use of~     cabergoline in a clinical trial, in order to define the efficacy of this treatment in~     nonfunctioning pituitary adenoma.~   "
22543|NCT03271905|"~     Aerosol therapy is widely used in intensive care in critically ill patients that use~     mechanical ventilation (MV). However, there is a lack of standardization about aerosol~     performance in this group of patients. Thus, this study aims to evaluate the effect of~     nebulization performed in different ventilatory modes on lung function and regional pulmonary~     distribution of critical patients with chronic obstructive pulmonary disease. It is a~     clinical trial, crossover, randomized, controlled and blind. Three interventions with~     bronchodilators will be performed: in the Pressure Controlled Ventilation mode (PCV) with~     positive end expiratory pressure (PEEP) = 85% of autoPEEP, in the PCV mode with PEEP = 15~     cmH2Oand in the Pressure Support Mode (PSV). Pulmonary function data will be evaluated~     through Electrical Impedance Tomography to evaluate the efficacy of the bronchodilator in~     different ventilatory modes.~   "
22544|NCT03271892|"~     This is a prospective observational study.~        1. In the first part of the study, consenting eligible adult patients with low risk~          papillary thyroid cancer that is confined to the thyroid, are provided verbal and~          written information about their disease and the option of active surveillance (close~          monitoring with intention to treat if disease progresses or if the patient changes~          her/his mind), as an alternative to thyroid surgery (thyroidectomy - traditional~          standard of care). Patients are free to make their own disease management choice (ie.~          active surveillance or thyroidectomy) and the investigators are examining how often~          patients choose each of these options. The investigators are also examining the reasons~          for their choice.~        2. In the second part of the study, consenting, eligible patients who completed the~          preceding part of the study and chose either a) active surveillance, or b) thyroid~          surgery, are tracked with respect to clinical and psychosocial outcomes as well as~          quality of life. Patients who chose active surveillance are free to change their mind~          and have surgery at any point, even if the disease does not progress. The primary study~          outcome is decision regret at one year, in the respective groups of patients who chose~          active surveillance or thyroidectomy.~   "
22545|NCT03271879|"~     Empagliflozin treatment in high cardiovascular risk patients has been shown to have a~     relatively rapid powerful capability in reducing cardiovascular mortality. Among the~     suggested mechanisms mediating this effect of empagliflozin, anti-arrhythmic effect (AAE) has~     the highest potential to translate into a rapid clinical beneficial effect on cardiovascular~     mortality, while other mechanisms are known to have a lag in their clinical effect based on~     data from previous studies. Based on this assumption, the study driving hypothesis is that~     the effect of empagliflozin on the rate of cardiovascular death may be mediated by a direct~     effect on the risk for arrhythmic events (via a direct or an indirect effect on the~     myocardium). The current study aims at assessing the effect of empagliflozin on arrhythmias~     in diabetic patients with HF with reduced ejection fraction and relatively high arrhythmic~     burden. The objective of the current study is to demonstrate the effect of empagliflozin~     compared to placebo on the rate of ventricular arrhythmic events in type 2 diabetes patients~     with heart failure with reduced ejection fraction and high risk arrhythmic profile.~   "
22546|NCT03271866|"~     In this study, the investigators will investigate the impact and the related mechanism of~     metformin treatment on cognitive impairment of schizophrenia co-morbid metabolic syndrome~     (Sch-MetS). The study will recruit 40 Sch-MetS patients, 40 patients with schizophrenia only,~     and 40 patients with schizophrenia and higher risk factors for MetS. Then these patients will~     be randomized to metformin group or non-metformin control group (20 patients per arm) for 24~     weeks clinic trial. Clinical assessment will be done at screen/baseline, 4 week, 12 weeks and~     24 week. The specific aims are to compare metformin group versus controls on: 1) clinical~     core symptoms; 2) cognition. Biological samples also will be collected, and stored to~     research related mechanisms.~   "
22547|NCT03271853|"~     This study is designed to evaluate the Sentinel BreastScan II as well as the analysis of data~     by Therma-Scan.~   "
39832|NCT03045328|"~     This is an open‑label non‑randomized two‑center phase 2 study evaluating the safety and~     efficacy of concurrent therapy with ibrutinib and venetoclax in subjects with relapsed or~     refractory CLL/SLL.~   "
22549|NCT03271827|"~     Airway management is a core clinical skill in anaesthesia. Pre-oxygenation prior to induction~     of anaesthesia is standard practice to prevent desaturation. Apnoeic oxygenation in adults is~     effective and prolongs the time to desaturation. The effectiveness of apnoeic oxygenation in~     the adult is well document, however evidence in the paediatric is lacking. Therefore, the aim~     of this study was to investigate the effectiveness of apnoeic oxygenation during airway~     management in children.~      This was a pilot randomised controlled trial. Patients were randomised to either receive~     apnoeic oxygenation or standard care during the induction of anaesthesia. The primary outcome~     was the duration of safe apnoea, defined as a composite of the time to first event, either~     time for SpO2 to drop to 92% or time to successfully secure the airway, and the lowest SpO2~     observed during airway management. Secondary outcomes were number of patients whose SpO2~     dropped below 95% and number of patients whose SpO2 dropped below 92%.~   "
22550|NCT03271814|"~     In a double-blinded, randomized, parallel controlled design, patients with schizophrenia~     spectrum disorder will be exposed to a single dose of lipopolysaccharide (LPS) (LPS-patient).~     Clinical symptoms, blood samples, and brain imaging will be assessed at baseline and after~     LPS. There will be two comparison groups. Comparison groups include an age- and sex-matched~     healthy control group also exposed to the same LPS (LPS-control), and an age- and sex-matched~     sample of patients with schizophrenia on placebo (Placebo-patient). As in Phase I studies,~     multiple interim analyses are expected so the current design may be modified, which will be~     communicated during annual reports (21CFR312.30).~   "
22551|NCT03271801|"~     This study is investigating the impact of a skills training program in stimulus control of~     meals and snacks on zBMI. Participants will be randomized to a standard family-based obesity~     treatment intervention with education on child health or a standard family-based obesity~     treatment intervention with experiential learning about meal stimulus control strategies.~   "
22552|NCT03271788|"~     The main purpose of the study is to find out if MBSR (Mindfulness) in addition to~     occupational therapy, can improve the therapeutic results in stroke-patients and help~     relatives of stroke patients to improve their quality of life.~   "
22553|NCT03271775|"~     The study is examine the eye movements characteristics of patients with VOR gain deficits~     (overt and covert saccades) before and after physical therapy intervention program and~     examine the most effective physical therapy treatment program for patients with~     vestibulopathy.~   "
22554|NCT03271762|"~     The objective of the study is to demonstrate the non-inferiority for clinical efficacy of an~     endovascular treatment strategy with the MitraClip® in comparison with a surgical treatment~     strategy in patients with severe primary mitral regurgitation judged eligible for anatomical~     repair with the MitraClip® or mitral valve surgery with high surgical risk.~      This trial is a French, multicenter and randomized trial. Patients enrolled will be~     clinically followed for 2 years ( clinical visit at 1 month, at 6 months and 12 months, phone~     call at 18 months and clincial visit at 24 months).~   "
22555|NCT03271749|"~     Introduction:~      Aiming at reducing costs and optimizing the use of these financial resources, several~     postoperative recovery protocols have emerged that aim to reduce the length of hospital stay~     by accelerating surgical recovery.1,2 In view of the current Brazilian political and economic~     scenario allied to the existing scientific knowledge on the subject , the investigators~     developed a protocol that aims to meet this need using resources already available and~     offered in brazilian public health system. The investigators called this protocol as Protocol~     of Operative Recovery Santa Marcelina (PROSM) that had as inspiration the protocols of~     accelerated postoperative recovery already used in several European health services.~      Goals:~        1. To evaluate the impact of PROSM on the length of hospitalization in days and~          postoperative pain (visual analog pain scale - VAS) in patients submitted to surgical~          procedures performed by the thoracic surgery team of the Hospital Santa Marcelina de~          Itaquera.~        2. Evaluate the impacts of PROSM in reducing the costs (US dollars) of surgical treatment~          and hospitalization of these patients.~      Materials and methods:~      A group of 200 patients with elective pulmonary resections (segmentectomies, lobectomies or~     pneumonectomies) to treat neoplastic lung diseases will be selected by the investigators.~      The participants will be randomized into two groups (rate of randomization 1/1).~      The first group will be submitted to the standard surgical treatment that is currently used~     in Santa Marcelina - Itaquera hospital. The second group will be submitted to treatment with~     the adoption of the PROSM guidelines, which will be detailed later.~      Investigators will evaluate in the two groups: surgical time in minutes, intraoperative~     complications: intraoperative bleeding in mililiters, need for transfusion of blood products,~     intraoperative clinical complications. Investigators will also evaluate the need for~     postoperative recovery in Intensive Care Unit (ICU), medications used to maintain the~     anesthetic plane during the procedure (amount of drugs in milligrams), medications used for~     postoperative analgesia, length of hospital stay in days, postoperative clinical~     complications, need for surgical re-boarding, immediate postoperative pain (VAS),~     postoperative pain at the time of discharge and the first outpatient return (VAS), the need~     for opioid analgesics at home after discharge.~      After the data collection, the investigators will analyze them and make a comparative study~     of the costs of surgical treatment and hospitalization between the two groups. This data will~     be obtained from the billing department of the Hospital Santa Marcelina de Itaquera.~   "
22556|NCT03271736|"~     Patients with Parkinson's disease have internal rhythm dysfunction, which may affect the~     rhythmic movements such as walking. Poor regularity of the rhythmic movement may lead to~     freezing of gait. This study will apply rhythmic auditory cues on the stepping-in-place~     training and the investigators will examine if the behavior and neuroelectrophysiology would~     change after auditory cueing training. The investigators hypothesize the variation of~     rhythmic movements such as walking and stepping-in-place will be reduced, and the cortical~     excitability would be modulated after training.~   "
22557|NCT03271723|"~     This is the fourth birth cohort to be carried out in the city of Pelotas (Brazil) including~     more than 4 thousand children followed-up since the pre-natal period to study maternal-child~     health.~   "
22558|NCT03271710|"~     The ENTRAP Study is a prospective, multi-center, non-randomized, single-arm, study with~     follow-up to 30 days to determine the acute safety, acute device performance and clinical~     performance of the Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic~     Protection. The Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic~     Protection is indicated for peripheral vascular percutaneous transluminal angioplasty (PTA)~     and capture and removal of embolic material during angioplasty for the femoral, iliac,~     popliteal and profunda arteries.~   "
22559|NCT03271697|"~     This research is trying to see if AM can enhance the clinical prognosis for spontaneous~     aneurysm ruptured subarachnoid hemorrhage patients.~   "
22560|NCT03271684|"~     The effectiveness of the adapted Bridge's self-management programme in South African~     community-dwelling stroke survivors: A randomized controlled trial with two arms will be~     used, with the intervention group receiving self-management sessions delivered by experienced~     therapists and usual care and control group will only receive usual care which includes a~     information booklet.~   "
25035|NCT03239314|"~     The purpose of this study was to evaluate the efficacy of ultra-sound guided adductor canal~     block with and without dexamethasone when added to bupivacaine on the duration of~     postoperative analgesia in patients undergoing arthroscopic anterior cruciate ligament~     reconstruction surgery using Numeric Rating Score (NRS).~   "
22561|NCT03271671|"~     Acute respiratory failure (ARF) is a life-threatening emergency which occurs due to impaired~     gas exchange. In the US, the number of hospitalisations owing to acute respiratory failure~     was 1,917,910 in the year 2009.(1) The incidence of ARF requiring hospitalization was 137.1~     per 100,000 population.(2) In ARF due to chronic obstructive pulmonary disease (COPD) and~     cardiogenic pulmonary edema, non-invasive ventilation (NIV) has been shown to be beneficial.~     NIV also has several advantages over invasive mechanical ventilation. These include,~     avoidance of endotracheal intubation and its attendant complications like airway injury,~     nosocomial infections, and possibly shorter duration of intensive care unit (ICU) stay.(3, 4)~     The success of NIV depends on several factors like the etiology of the respiratory failure,~     careful monitoring by the treating physician, and also adequate cooperation of patient.~     Better synchrony of the patient's spontaneous breaths with the ventilator-delivered breaths~     may lead to better patient cooperation and thereby, better clinical outcomes.~     Patient-ventilator asynchrony (PVA) leads to dyspnea, increased work of breathing, and~     prolonged duration of mechanical ventilation.(5) Pressure support ventilation (PSV) is one of~     the commonest mode used during NIV. In a prospective multicenter observational study, severe~     asynchrony (defined as an asynchrony index of >10 %) was seen in 43% of patients of patients~     with ARF ventilated by NIV with the conventional PSV mode.(6) Neurally adjusted ventilator~     assist (NAVA) is new mode of ventilation which utilizes the electrical activity of the~     diaphragm to deliver the breath.(7) During NAVA, breath is delivered when the patient's~     diaphragm starts contracting. Further, the amount of pressure support given during the breath~     is proportional to the strength of the electrical signal from the diaphragm. Finally, NAVA~     also terminates the breath when the electrical activity of the diaphragm wanes. NAVA has been~     shown to avoid over-assistance, decrease intrinsic positive end-expiratory pressure (PEEP),~     and minimize wasted efforts.(8) Hence, NAVA may play a major role in improving~     patient-ventilator synchrony.~      In a pooled analysis of studies comparing NAVA with PSV during NIV, it was shown that the use~     of NAVA significantly improved patient-ventilator synchrony.(9) However, so far, no clinical~     trial has demonstrated that this improvement in synchrony translates into better clinical~     outcomes. In this randomized controlled clinical trial, we intend to compare the rates of NIV~     failure and mortality between NAVA and PSV in subjects with acute respiratory failure managed~     with NIV.~   "
22562|NCT03271658|"~     Patients and families want to be involved in healthcare decisions [1]. When the~     decision-making process does not engage older patients and their families, the care provided~     does not match patient preferences or meet their needs [2]. Healthcare teams can collaborate~     to support patients and families facing difficult healthcare decisions, such as decisions~     about the use of technology used to keep a person alive when they are critically ill. Tools~     called patient decision aids are used in many health care settings to help patients and~     families understand their options and figure out the benefits and harms of a treatment to~     decide what is right for them [3,4]. The healthcare team can make sure that they understand~     the information provided, give them opportunities to ask questions, and help them talk more~     about the decision with others. This research study is trialing an internet based patient~     decision aid class of intervention. It is anticipated that 120 hospitalized, seriously ill,~     older adult patients/ families and their healthcare professionals will be recruited. The~     study will determine if the intervention can improve dialogue about whether life sustaining~     technology for seriously ill older patients. The findings will contribute to what is already~     known about overcoming challenges to involving patients and families with a goal of keeping~     patients and families at the center of decisions about their health.~   "
22563|NCT03271645|"~     The research will utilise an open feasibility parallel groups trial to examine the impact of~     novel internet-delivered cognitive behavioural therapy (CBT) interventions for stress,~     anxiety, and depression compared to treatment as usual (face to face counselling and~     psychotherapy) in an employment context. Participants will consist of employees accessing~     services provided by employee assistance programmes (EAP) provided at the European~     headquarters of a large technology organisation.~   "
22564|NCT03271632|"~     The aim of this clinical trial is to assess the feasibility, safety and efficacy of~     autologous CAR T cell immunotherapy targeting multiple cancer cell surface antigens in~     relapsed and refractory multiple myeloma patients. Another goal of the study is to learn more~     about the persistence and function of CAR T cells in the body.~   "
22565|NCT03271619|"~     Patients at risk of developing life-threatening heart rhythms may require the implantation of~     a small device called a cardioverter-defibrillator (ICD), which constantly monitors the heart~     rhythm and delivers an electrical shock to the heart when indicated, in order to return the~     heart back to a normal rhythm. Many thousands of these devices have been implanted and are~     electrically active in patients who collapse and need resuscitation.~      When a patient with an ICD collapses, the device may discharge without warning while a~     rescuer is performing external chest compressions (cardiac massage). Conventional ICDs placed~     below the left collar bone typically deliver 35-50 J energy when they discharge, but newer~     ICDs placed under the skin (S-ICD) alongside the breastbone deliver a larger energy when~     discharging; typically 50-80J energy.~      Rescuers performing external chest compressions on a patient during conventional ICD~     discharge have reported the sensation of a painful electrical shock and permanent nerve~     damage. In these situations, rescuers appear to have been exposed to electrical current from~     the ICD considerably in excess of that which is considered a safe threshold.~      Studies of surface current resulting from discharge of conventional ICDs have been reported~     in excess of 100 mA which is far in excess of the safe 1 mA limit, and puts the rescuer at~     considerable risk of tissue damage and possible dangerous heart rhythms. The newer S-ICDs~     deliver approximately 50% more energy and have the potential to result in exposure of a~     rescuer to even higher currents.~      With increasing numbers of the S-ICDs being implanted, and the inevitability that rescuers~     will soon find themselves exposed to leakage current from these devices, there is a need to~     examine the leakage currents arising from these devices and assess any subsequent risk to a~     rescuer performing external chest compressions.~   "
22566|NCT03271606|"~     This is a single center, randomized,single blind study to investigate the effectiveness of~     enhanced recovery regimen (ERAS) in patients undergoing Video-assisted Mediastinal Surgery.~     And we also going to compare the effectiveness of ERAS with that of traditional regimen in~     these patients.~   "
22567|NCT03271593|"~     The impact of rotavirus vaccination on the burden of disease has been well documented.~     However, the anticipated reduction in hospital pressures has yet to be described. This study~     will provide quantitative measures of hospital pressure prior to and post vaccine~     introduction, provide a template for future hospital pressures studies related to vaccine~     introduction and provide measures which could be used in an economic evaluation.~   "
22568|NCT03271580|"~     The aim is to study the microenvironment of chronic biofilm infection in diabetic wounds~     which shows deregulated immune cells responses and biofilm interaction resulting in~     delayed/impaired/non wound healing. We seek to understand immune evasion strategy of biofilms~     and study mechanisms which biofilm modify macrophages phenotype and functions in such wounds~   "
22583|NCT03271385|"~     Differentiating hypertrophic cardiomyopathy (HCM) from hypertensive heart disease (HHD)~     unavoidably encounters diagnostic challenges especially in patient of suspected HCM with~     history of hypertension. Diverse and overlapping forms of HCM can often lead to ambiguity~     when diagnosis is based on a single genetic or morphological index.~      The investigators have deduced a integrated formula based on cardiac magnetic resonance (CMR)~     imaging and established a differentiating flow-chart between HCM and HHD, the investigators~     aim to identify their method in the current multi-center trial.~   "
25054|NCT03239067|"~     This is a prospective, single-center study to assess the long- and short-term outcomes of~     ticagrelor vs clopidogrel in Chinese patients with acute coronary syndrome undergoing~     percutaneous coronary intervention. When 4500 patients have completed the follow-up, an~     interim analysis will be performed.~   "
22569|NCT03271567|"~     Diagnosis and treatment of tuberculosis are often delayed in hospitalized patients, leading~     to worse outcomes. Rapid diagnosis of tuberculosis currently relies on microscopy and~     molecular techniques, which have limitations including low sensitivity and high cost.Highly~     sensitive diagnostic technique is needed for more accurate rapid diagnosis of tuberculosis to~     aid earlier initiation of antituberculous therapy. Detection of Mycobacterium tuberculosis~     (MTB) antigens in the bloodstream can potentially allow early diagnosis of tuberculosis. This~     study aims to evaluate the diagnostic performance of a novel assay using nanotechnology to~     detect MTB antigens in patients admitted to hospital with suspected pulmonary and/or~     extrapulmonary tuberculosis. Blood will be taken from eligible patients, and will be sent to~     the School of Biological and Health Systems Engineering, Arizona State University, for~     detection of 10-kDa culture filtrate protein (CFP-10) and the 6 kDa early secretory antigenic~     target (ESAT-6), two antigens specific for MTB, using the Nanodisk-MS assay. Investigations,~     including microscopy, culture, MTB polymerase chain reaction (PCR), and imaging, will be~     performed for diagnosis of tuberculosis. The diagnostic performance of Nanodisk-mass~     spectrometry (MS) assay will be evaluated.~   "
22570|NCT03271554|"~     Alectinib was approved by the Ministry of Food and Drug Safety (MFDS) in Korea in Oct 2016.~     The purpose of this registry is to investigate and confirm the type and incidence of newly~     identified adverse events and any other factors affecting safety and effectiveness of the new~     drug so that the regulatory authority can manage the marketing approval properly.~   "
22571|NCT03271541|"~     This proof-of-mechanism study is being performed to investigate the safety, tolerability,~     efficacy, pharmacokinetics, and pharmacodynamics of multiple oral doses of bitopertin in~     adults with NTD beta-thalassemia.~      This study consists of two parts:~      Part 1 - The main study - 16 weeks in total: Participants will undergo a 6-week~     dose-escalation period followed by 10 weeks of treatment at the attained target dose.~      Part 2 - Open Label Extension (OLE) - up to an additional 12 months. Participants will be~     given the option to enroll into the OLE once the 16-week treatment of Part 1 has been~     completed. Participants who decide not to enroll in the OLE, at the end of Part 1 will enter~     a 6-week follow-up period.~   "
22572|NCT03271528|"~     This is a double-blind, randomized, placebo-controlled, crossover design trial that will test~     the effect of lacosamide on alcohol self-administration and craving following a priming dose~     of alcohol. The specific objective of this proposal is to determine whether lacosamide, a~     novel anticonvulsant that is FDA-approved for treating partial seizures, has effects on~     alcohol consumption.~   "
22573|NCT03271515|"~     This study aims to evaluate the safety, efficacy and duration of response of anti-CD19~     anti-CD20 Bispecific Chimeric Antigen Receptor (CAR) redirected autologous T-cells in~     patients with high risk, relapsed CD19+ and CD20+ haematological malignancies.~   "
22574|NCT03271502|"~     The purpose of this study was to evaluate the difference between the optic nerve sheath~     diameter measured during total intravenous anesthesia and the optic nerve sheath diameter~     measured during inhalation anesthesia in patients undergoing robot-assisted laparoscopic~     prostatectomy.~   "
22575|NCT03271489|"~     This phase 3b study seeks to evaluate the safety and efficacy of elagolix in combination with~     estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated~     with uterine fibroids in premenopausal women. This study is double-blinded in the first year~     and an open-label in the second year.~   "
22576|NCT03271476|"~     The study will consist in an adjustment/adaptation of the standard EMDR protocol for cancer~     disease, and most particulary for women who present a breast cancer and during adjuvant~     therapy. It will also test the faisability of the research, with a view to adjust the~     calendar and the ressources to put at disposal for a randomized control trial that follow.~     This study will also allow to test the need and acceptibility of this new psychotherapy for~     the patient, and to identify facilitators and obstacles : participation/rejection ratio,~     inclusion rythm, adhesion of the medical staff about the project~   "
22577|NCT03271463|"~     The purpose of this study is to compare the clinometric (psychometric) properties of the~     SCALE and FMA-LE assessments in adults after stroke. A second purpose is to determine how~     well each measure predicts walking speed using the 10 meter walk test.~   "
22578|NCT03271450|"~     Approximately half a million Americans annually experience venous thromboembolic disease,~     including deep venous thrombosis (DVT) and pulmonary embolism (PE). Since 2010, four new oral~     anticoagulants have been approved for marketing in addition to the vitamin K antagonist~     warfarin. Very limited head-to-head data exists comparing these treatment options, leaving~     patients, clinicians, and other stakeholders with little guidance for selecting the best~     strategy that balances recurrence reduction with risk of bleeding. In the DARE Warfarin CER~     Study, the researchers compare all five currently available oral anticoagulant agents for the~     extended treatment of DVT and PE, as well as no extended treatment. This study also aims to~     evaluate whether treatment heterogeneity exists for specific populations, such as older~     patients or those with renal dysfunction. In a secondary aim, the study will also leverage a~     database of linked electronic health record-insurance claims to validate diagnosis~     definitions and account for potential residual confounding by factors unmeasured in claims~     data. As the patient population includes all Medicare novel anticoagulant users and large~     numbers of commercially insured and Medicaid patients, the results will likely be~     transportable to the majority of US patients experiencing a DVT or PE. Pursuant to the~     objectives of the Patient-Centered Outcomes Research Institute, a study advisory committee~     consisting of key stakeholders will be actively involved in the study design and~     dissemination of results.~   "
22579|NCT03271437|"~     This study will test the eye movement desensitization and reprocessing (EMDR) based Flash~     technique and a progressive counting (PC) based variant. EMDR-trained therapists will be~     trained in the standard Flash, and PC-trained therapists will be trained in PC Flash. In each~     group they will try it with a minor upsetting memory, and then with two more significant~     upsetting memories. Participants will use the subjective units of distress scale (SUDS) to~     rate distress pre- and post-treatment.~   "
22580|NCT03271424|"~     The investigators propose to improve HIV prevention and care through expanding HIV testing~     options to include self-testing for young women, their peers and their sex partners, and by~     facilitating linkage to care.~   "
25055|NCT03239054|"~     This study is a randomized controlled parallel arms trial. The purpose of this study is to~     evaluate if prescribing exercise in pregnancy can change maternal behavior towards exercise.~   "
22589|NCT03271307|"~     This is an unblinded cluster-randomized study to evaluate the feasibility and~     cost-effectiveness of HIV self-testing strategies compared to standard of care in outpatient~     departments (OPD) and sexually transmitted infection (STI) clinics. The first aim of the~     study will be conducted in Malawi at 15 clusters among 15,000 individuals (15 years or older)~     to test the feasibility and cost-effectiveness of group HIV self-testing for patients in OPD~     and STI clinic waiting areas. The second aim of the study will be conducted in Malawi at 15~     clusters among 7,500 individuals (15 years or older) to test the feasibility and~     cost-effectiveness of HIV self-testing for partners of newly identified HIV-positive clients.~   "
22590|NCT03271294|"~     The aim of the study was to assess the role of the Exair transvaginal mesh system to correct~     pelvic organ prolapse from a subjective and objective standpoint. Subjects treated with the~     Exair transvaginal mesh for prolapse between June 2013 and August 2015 was analyzed. Subjects~     with uterine prolapse underwent vaginal mesh hysteropexy. There were no hysterectomies done~     for uterine prolapse in this study. A composite score that included subjective criteria of~     absence of a bothersome bulge, no prolapse below the hymen and no retreatment was used to~     assess success.Transvaginal Exair mesh hysteropexy offers a good option for the management of~     large uterine prolapses precluding the need for a hysterectomy.~   "
22591|NCT03271281|"~     The aim of this non-randomised, prospective study is to investigate the applicability and~     prognostic value of angiogenesis PET/CT with the radioligand 68Ga-NODAGA- E[c(RGDyK)]2 in~     patients with neuroendocrine tumors (NETs).~   "
22592|NCT03271268|"~     Burn injury leads to hypovolemic then distributive shock. Fluid resuscitation remains the~     cornerstone of initial treatment of burn shock. However, fluid rescucitation can lead to~     fluid overload, which manifests most notably as lung edema.~      The peptide NT-pro-BNP, a biomarker of cardiac congestion secreted by the myocardium, as well~     as plasma CD146, an endothelial factor involved in angiogenesis and a marker of vascular~     congestion, may help identifying patients with risk of pulmonary edema and hypoxia .~      Our hypothesis is that these biomarkers may predict the occurence of pulmonary edema in~     severe burns patients.~   "
22593|NCT03271255|"~     Bevacizumab, as an antibody of vascular endothelial generated factor (VEGF), combined with~     the fluorouracil-based chemotherapy regimens for metastatic colorectal cancer, has become the~     classical first-line treatment. However, vast majority of patients eventually will suffer~     progression disease. The second-line treatment includes replacing chemotherapy regimens~     whistle continuing bevacizumab or other anti-VEGF antibodies, such as Aflibercept and~     Ramucirumab. Apatinib is a small molecule tyrosine kinase inhibitor (TKI), which can highly~     selectively bind to and strongly block VEGF receptor 2 (VEGFR - 2), also potently suppress~     the activities of Ret, c-kit and c-src, resulting in reduced cell migration, proliferation,~     and tumor microvascular density mediated by VEGF .There are already robust data showing that~     antibodies aimed at blocking VEGF signaling pathways combined with chemotherapy to treat~     advanced colorectal cancer is superior as compared to chemotherapy alone. Thus, we~     hypothesize that the effect of using the second-line chemotherapy regimens combined with~     apatinib may be superior to those combined with bevacizumab. In this study,the patients who~     have progressed following or on first-line oxaliplatin and 5-FU combined with bevacizumab are~     randomised into two arms. Patients in the experimental arm receive second-line FOLFIRI~     combined with apatinib and those in the control arm receive second-line FOLFIRI combined with~     bevacizumab. To compare the efficacy and safety of the two arms, progression-free~     survival(PFS) is the primary end point.If apatinib is superior to bevacizumab in the~     second-line setting,it is one possible option of anti-angiogenic therapy in combination with~     second-line FOLFIRI for treatment of advanced colorectal cancer.~   "
22594|NCT03271242|"~     The study is a combined health services research study and a clinical patient outcomes~     sub-study.~      The aims of the study are to give new knowledge on (RQ1) current implementation in mental~     health services of four evidence based practices for treatment of psychoses, (RQ2) how and to~     what degree implementation support affects the implementation, and (RQ3) whether improved~     implementation is associated with better clinical course and higher patient satisfaction.~      Pairwise randomized study in six health trusts on implementation of the four evidence based~     practices physical health care, antipsychotic medication, family psychoeducation, and illness~     management and recovery. Data on model fidelity and patient course/experience are collected~     at baseline and after 6, 12 and 18 months. 39 clinical units (CMHCs/departments) choose two~     practices and receive implementation support on one for 18 months after randomization. RQ1 is~     answered from baseline data, and RQ2 and RQ3 from data after 6-18 months.~   "
22595|NCT03271229|"~     Previous clinical trials have demonstrated the human body's own healing and regenerative~     cells can relieve the pain of arthritis. Bone marrow contains stem cells which can change~     into cells of various different tissue types, while platelet rich plasma contains growth~     factors. Both techniques have been shown to relieve pain and with this study the~     Investigators wish to compare the two treatments.~   "
22596|NCT03271216|"~     This is a study to determine if surveillance monitoring of general ward patients can reduce~     cardio-pulmonary arrest while maintaining an acceptable false alarms rate for nursing~     workload.~   "
22597|NCT03271203|"~     Osteoarthritis (OA) is a degenerative joint disease which causes joints to become painful and~     stiff. HOA is the second most common form of OA and is characterized by stiffness, joint pain~     and inflammation and tenderness in the knuckles or around the waist. This cross-sectional,~     qualitative interview study aims to explore the experience of erosive HOA as well as explore~     the content validity of the Michigan Hand Outcomes Questionnaire (MHQ) by conducting~     semi-structured combined concept elicitation (CE) and cognitive debriefing (CD) telephone~     interviews and real-time data capture. The conceptual model developed from this data will be~     used to support the development of GSK3196165, a human monoclonal antibody target for the~     treatment of HOA. The CE interviews (45 minutes duration) will explore the experience of~     subjects suffering with HOA and will collect information about symptoms, health related~     quality of life (HRQoL), treatment experience and the language used by subjects to describe~     them whereas the CD interviews (45 minutes duration) will assess the content validity of the~     MHQ. The real-time disease experience of subjects will be captured by the real-time data~     capture app-based activity over a period of 7 days. Approximately 30 subjects from the United~     States (US) of which 15 subjects will be erosive HOA and rest 15 will be non-erosive HOA.~   "
22598|NCT03271190|"~     The team Cognitive intervention, cognitive reserve and brain plasticity, Team 10, is part~     of the Canadian Consortium on Neurodegeneration in Aging (CCNA). The team's aim is to develop~     and test a multi-faceted intervention program meant to increase cognitive and brain reserve~     by providing cognitive stimulation through participation in cognitive training sessions and~     engaging leisure activities. This will be done with a partially randomized controlled~     double-blind preference trial with a comprehensive cohort design, in participants with~     subjective cognitive decline (SCD) recruited in Montreal and Toronto.~   "
22599|NCT03271177|"~     The purpose of this study is to determine if the routine use of a sheathless 7F guide~     catheter for transradial percutaneous coronary intervention (TR PCI) is non-inferior to a 6F~     sheath/guide combination with regards to radial artery injury (radial artery~     intimal-medial-adventitial thickening). To evaluate the radial artery, ultrahigh resolution~     ultrasonography (55 mHz) will be used to accurately quantify radial artery~     intimal-medial-adventitial thickness (IMT) at baseline and 90 days. A non-inferiority~     analysis will be performed to compare the degree of radial artery IMT at 90 days between the~     7F sheathless guide approach and the 6F sheath/guide combination.~   "
22600|NCT03271164|"~     This is a prospective randomized controlled case series in patients having a surgery for~     bilateral breast reduction. Objectives of the case series are to evaluate the safety and~     efficacy of the FBPM10 System when compared with standard of care (massages with vitamin E~     cream) in the treatment of post-surgical wounds.~   "
22601|NCT03271151|"~     Post-discharge pain after total knee arthroplasty remains problematic; many patients have~     excessive pain at the 2 week time point (and often thereafter). Reduction in opioid use has~     become a national goal, due to the 'epidemic' in opioid misuse.~   "
22602|NCT03271138|"~     The primary purpose of this randomized, double-blinded, placebo-controlled, crossover~     clinical trial is to evaluate the efficacy of dietary supplementation with Bifidobacterium~     infantis NLS super strain among celiac disease patients on a gluten-free who have persistent~     gastrointestinal symptoms.~   "
22603|NCT03271125|"~     The aim of this study was to evaluate the safety, feasibility and preliminary effects of a~     high-intensity rehabilitative multimodal training protocol carried out on treadmill on~     walking efficacy, mobility, balance, executive function, fatigue and health-related quality~     of life in a sample of persons with moderate to severe MS deficit of mobility compared to a~     control group that received a strengthening program of similar intensity.~   "
22604|NCT03271112|"~     In Reunion Island, people encounter environmental and social conditions leading to premature~     ageing and subsequent frailty. Social welfare has developped exercise programs to promote~     physical activity especially for elderly with higher risk factors of frailty, including low~     incomes.~      The study evaluates the potent benefit effect of such exercise program on physical~     performance and frailty improvement in seniors from Reunion Island. All seniors participate~     to a 12-weeks exercise program especially dedicated to this targeted population needs and~     ability.~   "
22605|NCT03271099|"~     This study seeks to enroll patients receiving a Survivorship Care Plan following curative~     therapy for cancer. Participants will be randomly assigned to receive usual care or to be~     followed by a Patient Navigator as part of their Survivorship Care Plan.~   "
22606|NCT03271086|"~     Family-centered Relaxation Breathing Training in the Pediatric Outpatient Clinic:~      The long term goal is to apply simple, low cost, assistive technologies (heart rate~     variability [HRV] biofeedback together with mobile health tools) to teach relaxation~     breathing in the Boston Medical Center pediatric clinic setting following a trauma-informed~     care model. For this research both a mobile app for relaxation breathing skills and reminder~     text messages will be provided for the at-risk target population. The investigators will~     assess the feasibility and acceptability of relaxation breathing intervention in 60~     parent-child dyads. These dyads will be randomly assigned to receive either (1) biofeedback~     relaxation training alone or (2) Technology-enhanced relaxation breathing (biofeedback~     relaxation training together with mobile health tools). Outcome measures will assess~     relaxation breathing practice, anxiety, and parental stress at the time of the intervention~     and at one month follow up.~   "
22607|NCT03271073|"~     Antiangiogenesis therapy plays an important role in cancer treatment. Apatinib showed good~     safety and efficacy as third-line therapy for advanced gastric cancer.We conducted this trial~     to investigate the safety and efficacy of apatinib combined with S1 after failure of~     first-line chemotherapy in advanced gastric cancer or gastroesophageal junction carcinoma~     patients.~   "
22608|NCT03271060|"~     The first technique described for interbody fusion was the anterior lumbar interbody fusion~     (ALIF).(20) For this technique, the intervertebral disc is accessed through a retroperitoneal~     or transperitoneal approach.~      While the posterior approach was first described by Russell Hibbs in 1911, in the 1950's,~     Cloward (7)popularized the posterior approach for a posterior lumbar interbody fusion (PLIF).~   "
22609|NCT03271047|"~     This is a multicenter, open-label, Phase 1B/2 study to evaluate the safety and assess the~     preliminary anti-tumor activity of binimetinib administered in combination with nivolumab or~     nivolumab + ipilimumab in adult patients with advanced metastatic colorectal cancer (mCRC)~     with microsatellite stable (MSS) disease and presence of a RAS mutation that have received at~     least one prior line of therapy and no more than 2 prior lines of therapy. The study contains~     a Phase 1b period to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose~     (RP2D) and schedule of binimetinib followed by a randomized Phase 2 period to assess the~     efficacy of the combinations.~   "
22621|NCT03270891|"~     This is a 6-month randomized, wait-listed, controlled pilot trial conducted in 6 department~     of family medicine (DFM) clinics at the University of Michigan (UM). Physicians practicing at~     a UM DFM clinical site who are willing to utilize pharmacogenomic (PGx) test results for the~     management of depression and/or anxiety will be enrolled. Patients of these DFM physicians~     who are adults with a new diagnosis of depression and/or anxiety and have a current~     prescription for an antidepressant will also be enrolled.~   "
22622|NCT03270878|"~     This study is intended to estimate the absolute bioavailability of Glasdegib by comparison of~     the pharmacokinetic exposures following administration of an oral, single dose 100 mg tablet~     vs. an IV infusion of a 50 mg IV dose in the fasted state in a crossover fashion to healthy~     volunteers.~   "
22610|NCT03271034|"~     Lipedema is a disorder characterized by massive, bilateral accumulation of fat below the~     waist and in the legs. Enlargement of the lower extremities is often accompanied by leg pain~     and accumulation of fluid. Little is known about the functional changes that lead to fat~     accumulation and pain in women with lipedema. The goals of this project is to conduct a~     comprehensive characterization of abdominal and femoral fat tissues from women with lipedema~     and to evaluate the potential effect of a diet-induced weight loss as a therapy.~      Once enrolled in the study, the following tests will be conducted on lipedema subjects: 1)~     characterization of body composition (fat tissue distribution), insulin sensitivity (response~     to insulin), adipose tissue biology, and vascular function (how arteries dilate/contract) and~     immune system function/inflammation. As control, we will have two control populations:~     BMI-matched women that are metabolically normal obese (MNO) and Metabolically Abnormal Obese~     (MAO) already analyzed in different studies at Washington University (IRB# 201512086 and~     201610005). The MAO and MNO subjects underwent the same testing described above for the~     lipedema. Therefore, we will use the data generated from IRB# 201512086 and 201610005 as~     comparison groups in the statistical analysis to understand differences and similarities~     between lipedema and obesity.~      A second aim of the study is to determine the effect of diet-induced weight loss on body~     composition, insulin sensitivity, adipose tissue biology, and vascular function in the women~     with lipedema and compare these results with data obtained from BMI-matched women with MAO~     participating in another study at Washington University (IRB# 201512086). The MAO population~     will be used as control populations and data generated from the IRB# 201512086 will be used~     as comparison group for statistical analysis. The results from this second aim of the study~     will hopefully provide important insights on the efficacy of diet therapy in managing~     lipedema.ed~   "
22611|NCT03271021|"~     A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of~     Topical Administration of FMX101 for 12 Weeks in the Treatment of Moderate-to-Severe Acne~     Vulgaris (Study FX2017-22)~   "
22612|NCT03271008|"~     Comparison of various videolaryngoscope devices (Vividtrac™ and KingVision™) and direct~     laryngoscopy with Macintosh blade regarding laryngoscopy time, intubation time, intubation~     success rate, percentage of visible glottic opening (POGO score) in elective and acute~     clinical anaesthesiology practice.~   "
22613|NCT03270995|"~     Studies show that cancer survivors have unmet needs, the most frequently cited being fear of~     recurrence (FCR). Moderate to high levels of FCR have been reported by as much as 49% of~     cancer patients and are more prevalent among women. FCR is associated with psychological~     distress, lower quality of life, and increased health care utilization. Little evidence~     exists that these problems are being addressed by current medical management.~   "
22614|NCT03270982|"~     Clinical Data evaluation to document the performance and clinical outcomes of the~     Comprehensive Segmental Revision System.~   "
22615|NCT03270969|"~     Human immunodeficiency virus (HIV) persists worldwide as an immense health burden among~     vulnerable populations. HIV pre-exposure prophylaxis (PrEP) has offered the promise of~     limiting the global burden of HIV. The objective of this proposal is to conduct a~     pharmacokinetic (PK) study in transgender women to describe the pharmacokinetics of tenofovir~     disoproxil fumarate/emtricitabine (TDF/FTC) as PrEP within this population.~   "
22616|NCT03270956|"~     Therapeutic intervention with NKA is intended to delay the need for renal replacement therapy~     (dialysis or transplant) which, based on the current standard of care, is inevitable for~     patients with end stage CKD. The purpose of the present study is to assess the safety and~     efficacy of up to 2 injections of NKA given 3 months (+12 weeks) apart.~   "
22617|NCT03270943|"~     The rate of depression increases markedly over the course of adolescence. Adolescents~     struggling with depression are often set on a maladaptive behavior trajectory which may lead~     to academic challenges, substance abuse, risky sexual behavior, impairment in relationship~     building, and suicidality. The S.M.A.R.T Project (Stress Management and Resilience Training~     for Teens) is designed to learn about mood in teens, and whether emotional well-being can be~     improved with an 8 week class. The study proposes to refine and test the feasibility of a~     mindfulness-based self-compassion training program for adolescents who are experiencing~     subsyndromal depression, comparing it with a healthy lifestyles group program as a~     comparison attention-control for the treatment intervention. Secondarily, the study will~     explore the impact of these programs on measures of psychopathology and well-being (i.e.~     depressive symptoms and resilience).~   "
22618|NCT03270930|"~     Introduction Operative duration is an important but under-studied predictor of mortality in~     emergency laparotomies.~      Aims & Objectives The objective of this study was to quantify the effect of duration of~     emergency laparotomy in children on mortality and to identify a rough cut-off duration of~     laparotomy to serve as a guide to plan the laparotomy to optimize pediatric surgical patient~     outcome.~   "
22619|NCT03270917|"~     The international and multicentre ORANGE SEGMENTS - Trial is a prospective, double blinded,~     randomized controlled study comparing patients undergoing parenchymal preserving resection of~     postero-superior liver segments (involving one or two of segments 4a, 7, 8). All patients~     will be participating in an enhanced recovery programme.~      Primary outcome is time to functional recovery. Secondary study parameters include hospital~     length of stay, intraoperative blood loss, operation time, liver specific morbidity,~     readmission percentage, resection margin, quality of life, body image and cosmesis , reasons~     for delay of discharge after functional recovery, long term incidence of incisional hernias,~     hospital and societal costs during one year, time to adjuvant chemotherapy initiation,~     overall five-year survival.~   "
22620|NCT03270904|"~     Diabetic foot disease is a global health problem. Diabetes affects over 450million people~     worldwide, expected to rise to 1 in 10 people by 2040. 60-70% will lose sensation in their~     feet and up to 25% will develop a diabetic foot ulcer (DFU - a wound on the foot). More than~     half of DFUs become infected requiring hospitalisation and 20% of infections result in~     amputations contributing to 80% of non-traumatic amputations performed in the developed~     world. DFUs cost the NHS £1billion in financial year 2014-15.~      A diabetic foot ulcer is a form of chronic wound. Chronic wounds are wounds that fail to~     progress through the normal phases of wound healing in an orderly and timely manner and~     become hard to heal. Almost all chronic wounds are known to have bacteria within and this is~     termed colonisation. Wounds can progress from being colonised to becoming infected. The~     concentration of bacteria can predict delayed healing or infection.~      This study aims to use a novel hand held device, Moleculight i:X™, in a pilot study to~     investigate the clinical effectiveness and decision making associated with its use in the~     assessment of DFUs. Moleculight i:X™ is a hand held device that emits violet blue light. By~     controlling distance from the wound and ambient light, Moleculight i:X™ identifies bacteria~     above a pre-determined concentration by identifying natural fluorescence in the bacteria cell~     wall.~      Patients attending a specialist DFU clinic will be screened and if eligible and consenting~     will be recruited. Patients will be randomised into two groups; those who receive treatments~     as usual (TAU) alone (in line with NICE guidelines) and those that receive TAU plus~     Moleculight i:X™ imaging. The main objective is to describe the proportion per group with~     healed DFUs at 12week follow up in these two comparable groups of 30 patients each.~   "
22623|NCT03270865|"~     The purpose of the study Usability and Ergonomic Evaluation of Self-Positioning System for~     Retinal Imaging is to enable self-operation of a monitoring device in home-simulated~     environment~   "
39833|NCT03045315|"~     Previous studies in animal model showed clearly that lipid homeostasis influence oocyte~     meiosis resumption. However Liver X Receptors pathway has never been investigated in human~     ovocyte~   "
22625|NCT03270839|"~     Sea sickness represents a major limitation on the performance of ships' crew. One of the~     challenges faced by the physician in the motion sickness clinic when prescribing anti-sea~     sickness medication is to select the appropriate drug for the patient. Difficulties arise due~     to high variability in the response to different drugs. In the case of sea sickness, the~     current procedure is to examine the drug's efficacy in each individual during real time~     exposure to sea conditions.~      A number of studies have documented the presence of sea sickness drug receptors in the~     vestibular nuclei, which determine the vestibular time constant. Two clinical vestibular~     tests which evaluate the time constant are the Velocity Step and OKAN tests. The purpose of~     the proposed study is to evaluate the influence of motion sickness drugs on the vestibular~     time constant, as a possible bioequivalent of drug potency in the individual subject. Eighty~     crew members will be recruited and divided into groups responsive and non-responsive to the~     sea sickness drugs scopolamine and meclizine.~      Subjects having a Wiker score of 7 in waves 1 meter high without drug treatment, and no~     improvement in symptoms after treatment will be defined as non-responsive to sea sickness~     drugs. Subjects having a Wiker score of 7 in waves 1 meter high without drug treatment, and a~     Wiker score of 4 or less after treatment, will be defined as responsive to drug therapy.~      Kwells, Bonine and placebo, will be assigned to each subject in a random, double-blind~     fashion. Each group will perform the Velocity Step and OKAN tests before, one and two hours~     after drug or placebo administration.~   "
22626|NCT03270826|"~     Introduction: new methods of evaluation of respiratory function, such as electrical impedance~     tomography (EIT) and optoelectronic plethysmography (OEP), have been used to measure regional~     pulmonary ventilation and the variation of tricompartmental volumes of the thoracic cavity,~     respectively. Analysis of these instruments during maximal respiratory maneuvers with~     monitoring of esophageal pressure may probably provide additional information on the~     physiological behavior of the cardiorespiratory system during EIT and OEP maneuvers.~     Objectives: To describe the physiological behavior of maximal respiratory maneuvers through~     the electrical impedance tomography and optoelectronic plethysmography in healthy men.~      METHODS: This is a cross-sectional study involving 10 healthy male volunteers. The~     development of the method will take place in 3 stages. The first step corresponds to the~     characterization of the inspiratory and expiratory curves in the respiratory cycle generated~     by the impedance variation (ΔZ), the mobility of the chest wall and the pulmonary volume~     curve during maximal respiratory maneuvers. 2nd stage: verification of the correlation~     between the variables Step 3: Estimate the dislocated blood volume of the lung through~     previous analyzes.~   "
22627|NCT03270813|"~     The purpose of this study is to evaluate the use of Regulate and Gain Emotional Control~     (RAGE-Control), a biofeedback video game, in combination with brief instruction in relaxation~     skills as an intervention for symptoms of anger and aggression in children and adolescents.~     Half of the research participants will learn relaxation techniques and practice them using~     the RAGE-Control videogame. The other half of the participants will learn relaxation~     techniques and play a similar videogame without the biofeedback component. The investigators~     hypothesize that participants in the RAGE-Control group will show a greater reduction in~     symptoms of anger and aggression than those in the non-RAGE-Control group.~   "
22628|NCT03270800|"~     A Phase 1, multi-center, randomised, double-blind and adjuvant-controlled study to evaluate~     the safety, tolerability, and efficacy of IMX101 in H. pylori-negative and H. pylori-infected~     healthy volunteers.~      The study will be conducted in 2 phases. Phase A: Study design contains 6 cohorts, each~     containing 8 subjects. Three cohorts (24 subjects) will be H. pylori-negative and 3 cohorts~     will be H. pylori-infected. Subjects fulfilling the inclusion criteria will be assigned to~     one of 3 sequential dose cohorts with a 3:1 randomisation to IMX101 or to CTA within each~     cohort.~      Phase B: Two cohorts with H. pylori-infected subjects can be expanded up to 20 subjects in~     each cohort. The decision whether to expand the cohorts will be taken by the Sponsor and the~     DSMB, as soon as the results of the safety and efficacy analyses are available.~      Up to 72 subjects collectively in Phases A & B will be recruited. depending on immunogenicity~     status.~   "
22629|NCT03270787|"~     This study is to evaluate the efficacy and safety of compound danshen dripping pills in~     preventing and treating acute mountain sickness.~   "
22630|NCT03270774|"~     Background: Central Venous catheter insertion technique and indwelling time are major risk~     factors for CVC colonisation. Colonisation occurs through microbial migration and biofilm~     formation along the catheter insertion tract. This study set out to determine the prevalence~     and associated factors for central venous catheter colonisation among critically ill patient.~     No data exists in this clinical setting addressing this topic.~      Methods: The study population included 100 participants with central venous catheters in situ~     for at least 24 hours. Catheter tip (distal 5-cm segment) and blood cultures (10mls~     peripheral blood) were obtained at the time of catheter removal.~   "
22631|NCT03270761|"~     This is a multi-center study to report the demographic profile, clinical features, and~     management in patients with Iridocorneal endothelial (ICE) syndrome in China.~   "
22632|NCT03270748|"~     The experimental treatment consists in the application of a therapeutic strategy with post~     Transplant High-Dose Cyclophosphamide as GvHD Prophylaxis in Patients Receiving~     1-Antigen/Allele HLA Mismatched (7/8 matched) Unrelated Hemopoietic Stem Cell Transplantation~     for Myeloid Malignancies.~   "
22633|NCT03270735|"~     This is a multi-centre, randomised, double blind, placebo controlled clinical study which is~     designed to evaluate the efficacy and safety of hemocoagulase in the treatment of moderate to~     severe hemoptysis.~   "
22634|NCT03270722|"~     FLIP topography has been FDA cleared to evaluate a variety of esophageal conditions, but has~     never been evaluated in patients with scleroderma. The investigators hope to evaluate this~     technology in patients who have scleroderma and various esophageal symptoms, and compare to~     non-scleroderma patients.~   "
22635|NCT03270709|"~     Supplementation with vitamin D improves HIV+ macrophages phagocytosis in vitro. There is~     evidence to suggest that administering vitamin D can in fact improve immune function in~     individuals. The study will evaluate the impact of high dose vitamin D in HIV+ smokers' and~     HIV- smokers' in vivo. The primary goal is to improve innate immune host response to~     infection in patients already at high risk by virtue of HIV and smoking status.~   "
22636|NCT03270696|"~     This study is conducted to evaluate the efficacy of simultaneous injection of propofol and~     rocuronium in inducing general anesthesia.~   "
22637|NCT03270683|"~     Objective: To assess neurologic prognostication by early Transcranial Doppler Sonography~     (TCD) in comatose survivors after cardiac arrest.~      Design: Prospective study between May 2016 and November 2017 in a medical intensive care unit~     and cardiac intensive care unit in a university hospital.~      Patients: all comatose patients older than 18 years successfully resuscitated from an~     out-of-hospital cardiac arrest (OHCA). Patients for whom OHCA is associated with traumatic~     brain injury, no window for TCD measurements, or dead before neurological prognostication are~     excluded.~   "
22638|NCT03270670|"~     The purpose of this study is to test whether the 19-gauge needle can collect more tissue and~     get better sampling during a bronchoscopy procedure.~   "
22639|NCT03270657|"~     The purpose of this study is to measure neural activity during deep brain stimulation (DBS).~     There are two types of neural activity that we will record from DBS electrodes during this~     study: DBS local evoked potentials (DLEPs) and spontaneous, local field potentials (LFPs). We~     will measure the effects of varying stimulation parameters on both the neural activity and~     changes in motor symptoms -- bradykinesia and tremor -- in subjects with Parkinson's disease~     (PD). Correlating neural activity characteristics with changes in symptoms will improve our~     understanding of the mechanisms of action of DBS. This intraoperative study will specifically~     compare our ability to record neural activity using circuitry developed at Duke for this~     purpose [Kent et al, 2015] to a new, implanted pulse generator (IPG; RC+S) developed by~     Medtronic. These intraoperative studies will specifically test a preliminary version of the~     RC+S (that is not designed for implantation), and will lead to a clinical trial assessing the~     efficacy of the implantable RC+S IPG in PD patients once this device is available and~     approved for this trial.~   "
22640|NCT03270644|"~     This study will assess the effects on heart rate and blood pressure when a single dose of~     lasmiditan is administered with a daily dose of propranolol. This study will also measure how~     much lasmiditan gets into the bloodstream after taking lasmiditan alone and after taking it~     together with propranolol. The study will also look at how well both drugs are tolerated.~     Information about any side effects that may occur will be collected.~      This study will last approximately 45 days including screening. This study will require 13~     days/12 nights in a Clinical Research Unit (CRU) followed by 1 follow-up appointment~     approximately 7 days after the last dose. Screening is required within 28 days prior to the~     start of the study.~      This study is for research purposes only and is not intended to treat any medical condition.~   "
22641|NCT03270631|"~     Subjects are recruited from the attendees of the multidisciplinary low back pain~     rehabilitation group before it takes place in University Hospital of Oulu at Physical and~     Rehabilitation Medicine (PRM) unit. Subjects were invited to participate by letter 2 weeks~     before the beginning of the rehabilitation. Subjects to rehabilitation are picked by doctor~     at PRM unit. The volunteered subjects are invited to the briefing of the study and those who~     are willing to participate, they filled in several questionnaires about pain, participation,~     disability and mood. After that the subjects are measured at baseline measurement. Subjects~     are randomized into the five groups. After the 3 months treatment and training the follow-up~     measurements are performed. Same questionnaires are filled in at that point as well. At 6 and~     12 months the follow-up questionnaires (same as before) are sent to subjects.~   "
22642|NCT03270618|"~     The purpose was to assess the accuracy and clinical validation of virtual planning and~     surgical template in mandible distraction osteogenesis. Patients with hemifacial microsomia~     were enrolled. Virtual planning and simulation were performed on three-dimensional models.~     Distraction was simulated on virtual model and the new morphology of the mandible was~     predicted. The position and direction of the distractor was determined to achieve the optimal~     morphology. The templates were designed based on virtual planning and manufactured using~     three-dimensional printing technique. The template is designed to assist the surgeon to~     perform the osteotomy and predrill the screw holes to guide the distractor position. The~     outcome evaluation was completed by comparing planned outcomes with postoperative outcomes.~     Linear and angular differences for the distractor was measured.~   "
22643|NCT03270605|"~     Cesarean Myomectomy for safety regarding operative blood loss and need for further~     interventions and postoperative hospital stay.~   "
22644|NCT03270592|"~     For persons with impairments and certain illnesses the use of service dogs may have positive~     effect. The effects of using these dogs to assist in every day life need to be studied~     further.The aim of the study was to assess how health care consumption was effected by using~     certified service dogs and to study the cost-effectiveness of having a certified service dog.~   "
22645|NCT03270579|"~     The main purpose of the study is to measure the whole-body distribution and radiation~     dosimetry of [18F]JNJ-64511070 in healthy male participants by positron emission tomography~     (PET) (Part A); and to measure the uptake, binding, distribution, and washout of~     [18F]JNJ-64511070 in the brain of healthy male participants by PET and to model tissue~     specific kinetics of [18F]JNJ-64511070 with the appropriate arterial input function (IF)~     (Part B).~   "
22646|NCT03270566|"~     An outcome assessor-blinded pilot randomised controlled trial of an ion-exchange water~     softener for the prevention of atopic eczema in neonates, with an embedded mechanistic study~   "
22647|NCT03270553|"~     This is a single-center, Phase 1, open label, randomized, two-sequence, two-period, crossover~     study to evaluate the drug-drug interaction potential between plazomicin and metformin in~     healthy subjects.~   "
22656|NCT03270436|"~     Aim 1: To compare the effectiveness of the traditional Diabetes Prevention Program (DPP)-Life~     style Intervention (LI) and the Pacific DPP-LI among Marshallese living in Arkansas using a~     randomized controlled trial (RCT) with 378 overweight or obese, pre-diabetic participants~     where the unit of randomization is at the individual level. The primary outcome measure is~     percent weight loss relative to pre-intervention baseline weight. As selected by~     stakeholders, HbA1c, blood pressure, physical activity, and dietary intake will be evaluated~     as secondary outcome measures. Self-efficacy and social/family support will be examined as~     mediating variables. Data collection will take place at baseline (pre-intervention), six~     months (post-intervention), and 12-months (six months after the post-intervention to assess~     maintenance).~      Aim 2: To continue engaging Marshallese stakeholders in all aspects of research.~      Aim 3: To collaboratively and creatively disseminate results to a broad group of~     stakeholders, locally and nationally.~   "
22657|NCT03270423|"~     Randomised controlled trial in overweight adolescents using a health App.~   "
22648|NCT03270540|"~     Urinary tract infection (UTI) in a child may be the first symptom of congenital anomaly of~     the kidneys and the urinary tract (CAKUT). Thus, imaging diagnostics are warranted in~     children with first episode of UTI.~      Abdominal ultrasonography (USG) is the first line imaging modality in evaluating children~     with UTI. Abnormalities suggesting CAKUT found on USG are an indication for further, more~     invasive tests. The timing of USG in UTI depends on the clinical situation. It always should~     be performed urgently when serious acute complications of UTI are suspected. However,~     appropriate timing of USG in children responding well to therapy, is a matter of debate.~     According to animal studies, E. coli produces toxin which dilates the urinary tract. This may~     result in misleading picture on USG in acute phase of infection. Guidelines on UTI management~     in children differ in respect to recommended USG timing.~      The purpose of the study is to investigate how UTI does affect USG results in children and~     when its effect subsides.~      Methods 150 children up to 3 years of age, with the first episode of UTI, will be included in~     our study. Three USG examinations will be performed by single radiologist in every child:~        1. in the first day of treatment,~        2. two weeks after treatment initiation,~        3. four weeks after treatment initiation. Age, gender, etiologic factor, C-reactive protein~          concentration and white blood cells count will be included in statistical analysis.~      The study is aimed to help clinicians interpret USG findings during UTI and make reasonable~     plans for further imaging diagnostics in children with UTI.~   "
22649|NCT03270527|"~     Raised blood cholesterol (also referred to as blood LDL-cholesterol) is a major risk factor~     for developing heart disease. Dietary saturated fat is recognised as the main dietary~     component responsible for raising blood LDL-cholesterol, and reducing its intake has been the~     mainstay of dietary guidelines for the prevention of heart disease for over 30 years.~     However, there is very little evidence for a direct link between the intake of saturated fat~     and risk of dying from heart disease. One explanation for this, is that the link between~     saturated fat intake and heart disease is not a direct one, but relies heavily on the ability~     of saturated fat to raise blood LDL-cholesterol levels. This LDL cholesterol-raising effect~     of saturated fat is complex, and highly variable between individuals because of differences~     in the metabolism of dietary fat and cholesterol between people. The main aim of this study~     is to measure the amount of variation in blood LDL-cholesterol in 150 healthy volunteers (75~     at the University of Surrey and 75 at the University of Reading) in response to lowering the~     amount of saturated fat in the diet to the level recommended by the government for the~     prevention of heart disease. This collaborative project between the Universities of Reading,~     Surrey and Imperial ('RISSCI-1 Blood Cholesterol Response Study') will permit identification~     of two subgroups of men who show either a high or low LDL-cholesterol response to a reduction~     in dietary saturated intake. These participants (n=36) will be provided with an opportunity~     to participate in a similar follow-up study ('RISSCI-2') that will also take place at the~     University of Surrey and Reading. In this follow-up study, the participants will be asked to~     repeat a similar study protocol as for RISSCI-1, but undergo more detailed measurements to~     determine how saturated fat is metabolised in the body.~   "
22650|NCT03270514|"~     The aim of this study is to evaluate the analgesic efficacy and safety of wound infiltration~     with liposomal bupivacaine (LB) in patients undergoing cardiac surgery with sternotomy and~     cardiopulmonary bypass (CPB) and compare it with bupivacaine hydrochloride infiltration~   "
22651|NCT03270501|"~     The hypothesis of the study is that the presence of (subclinical) gut inflammation at~     baseline in patients with early active axial spondyloarthritis predisposes to a more severe~     disease defined as more need to use anti-tumor necrosis factor α therapy and a shorter time~     to relapse after stopping anti-tumor necrosis factor α therapy after obtaining sustained~     clinical remission. Overall, the investigators hypothesize that subclinical gut inflammation~     is an important predictor in therapy response and outcome. These data could provide better~     insights into the complex interactions between gut and joint inflammation and guide the~     physicians in the therapeutic approach.~   "
22652|NCT03270488|"~     Osteoarthritis (OA) is a chronic and prevalent joint disorder with great impact on quality of~     life and high economic burden. Although a number of conservative therapies have proven to be~     effective for the management of hand OA, only modest treatment effects were reported for most~     individual interventions. The aim of the proposed study is to assess the effect of laser~     therapy on pain, function and force in patients with carpometacarpal osteoarthritis (CMC OA).~   "
22653|NCT03270475|"~     The aim of the study is to investigate skeletal muscle proteome signature changes induced by~     exercise training in young men~   "
22654|NCT03270462|"~     This is a pilot study documenting the neurotoxic side effects including tremors in patients~     with a stable graft who are receiving Tacrolimus following kidney transplantation. A~     standardized questionnaire will be used to document these symptoms.~   "
22655|NCT03270449|"~     Fibromyalgia (FM) is a multi-factorial chronic pain condition characterized by fluctuating~     and heterogeneous symptoms. This leads to both reduced patient function and quality of life~     and consequentially, significant economic burden on the society. Although numerous~     pharmaceutical and multi-treatment approaches exist, there is lack of an integrated~     multidisciplinary model of care for these patients. Such a system is hypothesized to be~     beneficial for the patients and would help them regain function and significantly improve~     their quality of life. The primary aim of this pilot clinical trial is to evaluate the~     effectiveness of an integrated community-based multidisciplinary model of care for FM~     patients in Penticton and surrounding areas. The comprehensive 10 week intervention will~     provide care from a team of health care providers (psychiatrist, physiotherapist, certified~     exercise therapist, dietitian, rheumatologist, and mental health clinician). Patients will~     also attend a peer led pain self-management support group provided by the Arthritis Society.~     The study aims at educating these patients about self-management of their symptoms such as~     chronic pain, weight, sleep and mood disorders. The integration of health care between the~     different providers will be achieved by huddle sessions that will be conducted on a monthly~     basis. The evaluation of the study outcomes will be based on the RE-AIM framework. Data will~     be collected through patient questionnaires, healthcare utilization data, and interviews with~     providers. Data analysis will involve thematic analysis of qualitative data and statistical~     methods for quantitative data.~   "
22658|NCT03270410|"~     This is a preliminary study whose objectives are to define the clinical use cases and the~     constraints of the implementation of a multi-sensor image-sound system.~   "
22659|NCT03270397|"~     MSc. course addressing the issue of body image among nutrition students while delivering the~     course The group- theory and practice. A non-randomized controlled trial was conducted~     between 2014 and 2016 with 135 dietetics' students in Tel Hai Academic College, Israel.~     Changes in body image and eating disorders features were assessed between course conclusion~     and baseline among participants within controlled efficacy study.~   "
22660|NCT03270384|"~     The study described below is designed to assess the safety and device performance for the~     drug coated balloon (DCB) for the treatment of urethral stricture.~   "
22662|NCT03270358|"~     Our hypothesis is that a plasma protein named osteopontin (OPN) could serve as a biological~     predictive marker of acute AVF dysfunction. In several scientific studies, plasma OPN was~     correlated with coronary stent restenosis, and with cardiovascular outcome in patients with~     diabetes and renal insufficiency. This protein is secreted by several cellular types, like~     distal tubule epithelial cells, macrophages, but also fibroblasts and cardiac and vascular~     endothelial cells, in response to several specific stimuli. It acts like a cytokine, inducing~     immunological mechanisms as well as tissue remodeling.~      The main objective of this study is to show that the amount of plasma OPN is higher in~     patients presenting with an AVF stenosis, compared with patients with a functioning AVF.~      OSMOSIS is a monocentric pilot study that will include patients into two groups during 12~     months (no specific follow-up). The control group will include patients that have been~     dialyzed on an AVF, in the dialysis center of Nice University Hospital, for at least 3 months~     without any incident. The experimental group will include hemodialysis patients hospitalized~     in the department of vascular surgery for acute AVF dysfunction, needing endovascular or open~     surgical revision for venous stenosis.~      Blood will be withdrawn right before dialysis or surgical procedure. Plasma OPN will me~     measured by ELISA. Their clinical data would be collected from medical file at the same time.~     After the procedure, patients will be followed-up according to usual protocols.~      To show a significant difference of 100ng/mL plasma OPN between the two groups, with a power~     of 90% and alpha risk of 0.05, we plan to include 76 patients~   "
22663|NCT03270345|"~     The objective of this study is to provide an up-to-date, global picture of the extent and~     patterns of pressure injuries in ICUs. Point prevalence studies are only of value when~     performed on a vast scale. To sample a representative cohort, it is the intention to recruit~     about 1200 ICUs with all continents covered and as many countries as possible within each~     continent.~   "
22664|NCT03270332|"~     The purpose of the present pilot study is to test the hypothesis that in patients with group~     1 pulmonary arterial hypertension (PAH) who are on regular oral pulmonary vasodilator~     therapy, inhaled albuterol causes transient pulmonary vasodilation. If the results support~     this premise, they could serve as the basis for a phase 2 trial investigating the potential~     for using inhaled long-acting β2-adrenergic agonists as add-on therapy in group 1 PAH.~     Echocardiography will be performed before and after administration of inhaled albuterol.~   "
22665|NCT03270319|"~     Comparison of volumetric measurements obtained by three dimensional echocardiography with~     measurements obtained by thermodilution using a pulmonary artery catheter in the intensive~     care unit.~   "
22666|NCT03270306|"~     This case-control study aims to compare the differences in eating behaviours, nutritional~     status, diet quality and gastrointestinal (GI) health between Chinese children aged 3-6 years~     with autism spectrum disorders (ASD) (n=65) and typically developing children (TDC) (n=65).~   "
22667|NCT03270293|"~     Primary end point of the study was to evaluate clinically and by non-invasive instrumental~     evaluations tolerance and efficacy of a bio-revitalizing product containing hyaluronic acid~     with high (H-HA) and low (L-HA) molecular weight; the micro-injection of the study product~     was performed by a specialized dermatologist, bilaterally on the face (zygomatic~     protuberance, nostril's angle, inferior margin of tragus, lip marionette lines, mandibular~     angle) of healthy female volunteers aged 30-60 years.~      It was also aim of this study to evaluate efficacy by the volunteers and tolerance both by~     investigator and volunteers.~   "
22668|NCT03270280|"~     Periodontitis is an infectious inflammatory disease affecting the periodontal tissue~     (Gingivae, alveolar bone, periodontal ligament and cementum). Chronic Periodontitis is~     considered to be the most prevalent disease after dental caries which is linked to increased~     levels of C- reactive protein, interleukins and matrix metallo-proteinases. Interleukin- 1β~     and Matrix metalloproteinase-8 have been shown to be robust markers of inflammatory cascade~     of chronic periodontitis.Various treatment modalities including scaling and root planing,~     toothpastes and chlorhexidine based mouthwashes have been are known to be associated with~     various side effects like teeth staining, altered taste sensation, mucosal burning. Hence,the~     use of natural medicaments could provide a better alternative because of their fewer side~     effects and cost effectiveness.~   "
22669|NCT03270267|"~     Study of the causes and rate of school absenteeism in children and adolescents with~     Inflammatory Bowel Disease.~   "
22670|NCT03270254|"~     Gum disease is a common disease, which affects 45% of the UK adult dentate population. It is~     caused by bacteria in dental plaque, which produces inflammation and a deepening of the~     natural crevice between the gum and the tooth surface. A crevice of 3mm is considered to be~     within the normal range, but anything ≥4mm is considered to be abnormal and is called a~     pocket. Standard treatment of gum disease is mechanical cleaning aimed at removing bacteria~     off the root surfaces of the teeth. For most teeth, in the majority of patients, this can be~     achieved by root surface debridement (RSD), which involves passing instruments into the gum~     pockets to clean the roots. Previous studies have shown that the outcome of treatment is less~     effective when the pockets are deeper, or where there is bone or root anatomy which makes~     access for RSD difficult. In such instances additional approaches, such as repeating RSD,~     surgical access, or the additional use of antibiotics are considered. This clinical study~     will investigate the benefits and drawbacks of using a light source and dye (photodynamic~     therapy - PDT) as an additional treatment compared to the standard treatment of RSD alone.~     Patients with chronic gum problems who have undergone 1 cycle of RSD, but have residual~     pockets will be invited to join the study. All residual pockets will be treated with the~     conventional treatment of RSD. Following a random allocation process the residual pockets in~     half the mouth will receive additional treatment with PDT at the same appointment. Patients~     will be followed up for 3 months to evaluate the clinical benefits and any side effects. The~     aim of the study is therefore to evaluate if this localised, simple treatment can add benefit~     to RSD alone, thus reducing the need for antibiotics or surgery to treat residual pockets.~   "
22671|NCT03270241|"~     Vitiligo is a chronic acquired cutaneous disease of pigmentation that affects patients'~     quality of life across all degrees of involvement and severity. Phototherapy, such as Narrow~     band UVB (NB-UVB), is a clinically indicated treatment for skin lesions. NB-UVB treatment has~     been shown to promote repigmentation and normalize cellular behaviors. The investigators~     would like to analyze the change in protein expression and histological change in skin from~     NB-UVB treatment in participants with Vitiligo.~      The investigators are recruiting participants with Vitiligo on the body, arms, and/or legs.~   "
22673|NCT03270215|"~     To investigate the diagnostic power of computed tomography for discriminating malignant from~     nonmalignant causes to pleural effusions in consecutive patients with no malignant cells~     found at a cytological examination and a chest x-ray not suspicious of malignancy. The~     investigators hypothesised that the combination improves the chance of detecting the cause of~     the pleural effusion.~   "
22674|NCT03270202|"~     This study evaluates the effect of a new wearable device, that measures physical activity~     level based on heart rates, on relevant health outcomes including cardiorespiratory fitness.~     Half of participants will be instructed in using the Mio Slice wristband, while the other~     half will be requested to follow today`s recommendations for physical activity.~   "
22675|NCT03270189|"~     Cervical dystonia occurring only during the writing task is a rare form for which there is no~     established treatment. Many authors agree that alteration of sensory integration is~     associated with dystonia. Similar disturbances in the integration of oculomotor information~     could have a role in cervical dystonia forms involving visuo-cervico-manual coordination such~     as handwriting. We hypothesize that orthoptic treatment by wearing prisms when writing (i)~     will reduce the abnormal posture of the head occurring whilst writing and remove the~     associated nuchal pain; (ii) the correction after a period of systematic wearing of the~     prisms during handwriting tasks will have a sustainable effect allowing to keep a normal head~     position after the suppression of the prisms.~   "
22676|NCT03270176|"~     The study is primarily designed to assess the safety and tolerability of escalating oral~     doses of Debio 1143 and preliminary anti-tumour activity when combined with the standard dose~     of avelumab in participants with advanced solid malignancies.~   "
22677|NCT03270163|"~     Intensive care unit acquired muscle weakness (ICUAW), a common disease characterized by~     damage to the peripheral nervous system and/or muscles, is a serious condition with~     significant morbidity and mortality.~      The diagnosis of ICUAW is difficult and often delayed, because based upon clinical assessment~     of muscle strength (MRC score), requiring patients to be awake and cooperative.~      Transcutaneous electrical stimulation consists in applying electrical stimulation along a~     motor nerve in order to generate muscle contraction. The mechanical response thus generated~     is recorded, which allows to appreciate the generated muscular strength. This noninvasive~     procedure, which can easily be performed at the bedside, could represent an interesting tool~     to evaluate muscle strength, in ICU patients under deep sedation.~   "
22678|NCT03270150|"~     The study is a prospective open-label single-arm study that includes four treatment~     procedures and three follow-up visits. Outcomes will be measured according to photography~     evaluation, subject's satisfaction and occurence of AE.~   "
22679|NCT03270137|"~     Randomized clinical trial, comparative and single blind aims to determine effects on~     cognition, psychological and behavioral symptoms and functionality of 5 Hz repetitive~     transcranial magnetic stimulation (rTMS) administered over left dorsolateral prefrontal~     cortex (lDLPFC) compared to six regions protocol, divided in two sub-conditions: day 1 (Broca~     area, Wernicke area and lDLPFC) alternated by day 2 (left and right parietal association~     cortex, and right dorsolateral prefrontal cortex [rDLPFC]). Main outcomes will be evaluated~     at ending of 15 rTMS sessions and 4 weeks after.~   "
22680|NCT03270124|"~     This study is being performed in patients who have undergone transcatheter aortic valve~     replacement (TAVR) for aortic stenosis. The goal is to obtain pilot and feasibility data on a~     novel post-procedure rehabilitation strategy, including a daily activity goal using a~     waist-worn accelerometer and in-home resistance training exercises targeting muscles related~     to activities of daily living. We will evaluate the effect of these interventions on physical~     performance and several quality of life domains.~   "
22681|NCT03270111|"~     The purpose of this second pilot study is to extend the feasibility demonstrated in~     NCT02963740 that the intervention achieves high levels of moderate to vigorous physical~     activity (MVI PA) and modulates risk biomarkers for breast cancer and cardiovascular disease~     in older, obese sedentary breast cancer survivors who are undergoing moderate calorie~     restriction.~   "
22682|NCT03270098|"~     People with schizophrenia display a broad range of cognitive impairments that have been~     identified as major determinants of poor functioning and disability. The goal of the proposed~     study is to examine the impact of exercise training on cognition, daily functioning, and~     biomarkers of cognitive change in people with schizophrenia.~   "
22683|NCT03270085|"~     To compare with a randomized trial (n=15 per treatment group), effects of colesevelam and~     placebo treatment, on colonic transit, bowel functions, permeability and tight junction~     expression in rectosigmoid mucosa of IBS-D with Bile Acid Malabsorption.~   "
22684|NCT03270072|"~     The objective of the study is to serve as a correlative study for patients enrolled on the~     RadCOMP trial (NCT02603341), a randomized phase III study of stage II and III breast cancer~     patients treated with either conventional photon radiation or proton beam radiation~   "
22685|NCT03270059|"~     This randomized phase II trial studies how well gadolinium and ferumoxytol magnetic resonance~     imaging (MRI) works in diagnosing patients with abnormalities in the central nervous system.~     Diagnostic procedures, such as gadolinium and ferumoxytol MRI, may help find and diagnose~     abnormalities in the central nervous system.~   "
22686|NCT03270046|"~     The purpose of this study is to compare the preparation quality by using Ottawa Bowel~     Preparation Scale between the standard PEG preparation and the addition of water enema in~     participants scheduled for CRC screening~   "
22687|NCT03270033|"~     In this single-centre, double-blinded, randomized controlled superiority trial, 189~     participants having outpatient, arthroscopic shoulder surgery will be randomized into 3 equal~     sized groups. All participants will receive a standardized interscalene brachial plexus block~     and 4mg of dexamethasone or 50mcg of dexmedetomidine or both intravenously just prior to~     their surgery. The purpose of this study is to provide a head to head comparison of two types~     intravenous adjuncts to ISB, corticosteroids and alpha 2 agonists, and determine if their~     combination, or either one alone provides superior postoperative analgesia in arthroscopic~     shoulder surgery patients, as well as possibly show a synergistic relationship between the~     two adjuncts. The investigators hypothesize the combination of adjuncts will provide a longer~     duration of analgesia compared to either single agent.~   "
22688|NCT03270020|"~     This study is aiming to evaluate the efficacy of denosumab among adult patients suffering~     from Langerhans Cell Histiocytosis (LCH).~   "
22691|NCT03269981|"~     This study evaluates the impact of elective regional lymph node irradiation on N1 breast~     cancer patients receiving post-lumpectomy radiotherapy and anthracycline plus taxane~     (AT)-based chemotherapy. We randomly assign patients having one to three metastatic lymph~     nodes (pN1) after breast-conserving surgery (BCS) and AT-based chemotherapy to undergo either~     whole-breast and regional nodal irradiation (WB+RNI group) or whole-breast irradiation alone~     (WBI group).~   "
22692|NCT03269968|"~     Obese women are more likely have a cesarean delivery and develop subsequent wound~     complications than normal weight women. Negative pressure wound therapy (NPWT) has been shown~     to improve surgical wound healing, but this device has not been adequately studied in~     cesarean deliveries. The aim of our study is to determine the efficacy of NPWT in morbidly~     obese women after cesarean delivery.~      Investigators will be randomizing women with a BMI > 40 kg/m2 in a 1:1 ratio to either NPWT~     (the PREVENA Incision management therapy system Pre 1001 Us) or standard dressing after their~     cesarean delivery at MedStar Washington Hospital Center. The NPWT will be left in place for a~     minimum of four days but not to exceed seven days. The standard dressing is typically removed~     on postoperative day one or two. The primary outcome is a wound complication defined as the~     formation of a wound infection, seroma, hematoma, separation, or dehiscence from delivery to~     4 weeks postpartum. Investigators will also administer a patient satisfaction survey~     regarding their wound healing experience.~   "
22693|NCT03269955|"~     Fibrinogen/thrombin-coated collagen patch (TachoSil®) is known to have the effect of~     strengthening tissue anastomosis and promoting suturing to prevent leakage. The purpose of~     this study is to compare the incidence of pancreatic fistula that is most crucial for~     surgical outcome and complications in pancreaticoduodenectomy with those of the control group~     and the TachoSil® apply group.~      Patients who were planned to undergo pancreaticoduodenectomy without a history of chronic~     pancreatitis are enrolled in this open-label, single-center, randomized, single-blind, phase~     4 clinical trial.~   "
22694|NCT03269942|"~     The investigator expects that endovascular flow-diversion is superior over revascularization~     by postoperative modified Rankin scale (mRS) in patients with complex intracranial aneurysms.~   "
22695|NCT03269929|"~     This study aimed to compare the efficacy of music therapy and midazolam 0,02 mg/kgBW in~     reducing preoperative anxiety on patients undergoing brachytherapy with spinal anesthesia~   "
22696|NCT03269916|"~     ECCO consensus, the fertility would decline in activity inflammatory bowel disease(IBD),~     because of anus lesions and pelvic abscess, or who underwent surgery, especially in patients~     with ileal pouch anal anastomosis (IPAA) storage.The study on fertility in inflammatory bowel~     disease were almost epidemiological investigation, the lack of objective evaluation of~     fertility, and controversial.This study will explore the fertility, ovarian reserve function~     and the pregnancy outcomes in patients with IBD.~   "
22697|NCT03269903|"~     A multicenter non-randomized prospective clinical study assessing the safety and feasibility~     of the esophageal through-the-scope HILZO Covered self-expandable metal stent placement for~     palliation of malignant dysphagia~   "
22698|NCT03269890|"~     Thyroid gland surgery is one of the most commonly performed operations for either benign or~     malignant pathologies Pain related to thyroid surgery is of moderate intensity .which may be~     treated with NSAIDs or opioids. However, Opioids have many well-known undesirable effects,~     including postoperative nausea and vomiting, which are frequent after this type of procedure.~   "
22699|NCT03269877|"~     The spleen could be considered a neglected organ. To date, it has been deemed an ancillary~     organ in portal hypertension or an organ localization in lymphoproliferative diseases.~     Hypersplenism is a common disorder characterized by an enlarged spleen which causes rapid and~     premature destruction of blood cells. It can result from any splenomegaly. It is most common~     with splenomegaly secondary to portal hypertension and hematological disorders. Portal~     Hypertension is an important cause of splenomegaly in most tropical countries This work will~     involve a series of studies aiming to:~        1. Assess the prevalence and pattern of hypersplenism, and grade the severity of cytopenias~          in patients with cirrhosis and portal hypertension.~        2. Elucidate the relationship between hypersplenism, in these patients, and:~             1. The severity of liver cirrhosis as assessed by Child's and the Model of End-stage~               Liver Disease (MELD) scores.~             2. The presence and grade of gastroesophageal varices as assessed by upper endoscopy.~             3. The presence of hepatocellular carcinoma~             4. Portal hemodynamics and portal vein thrombosis as assessed by Doppler Ultrasound.~        3. Test the hypothesis that leucopenia in cirrhotic patients may be caused, at least in~          part, by apoptosis of polymorphnuclear leucocytes.~   "
22700|NCT03269864|"~     Perforator vessels are those where the source artery is deep and the branch that carries~     blood to the fasciocutaneous tissues passes through the overlying deep fascia.~      Soft tissue defects in the lower extremity, especially distal third of leg, present a~     challenge to reconstructive surgeons due to lack of reliable local flaps, conventional~     reconstructive options include split skin grafting, local random fasciocutaneous flaps, cross~     leg fasciocutaneous flap, pedicled muscular or musculocutaneous flaps or microvascular free~     tissue transfer. All these procedures have their limitations and associated morbidity at~     donor site~   "
22701|NCT03269851|"~     To detect Radiological parameters affecting neurological injury after thoracolumbar spinal~     fractures.~   "
22702|NCT03269838|"~     To correlate QT dispersion on 12-lead surface ECG with myocardial reperfusion evaluated by~     myocardial blush grade and Thrombolysis in myocardial infarction (TIMI) flow grades in~     patients with ST elevation myocardial infarction treated by Primary Per cutaneous coronary~     intervention~   "
22703|NCT03269825|"~     This is a retrospective, observational study and will investigate the clinical predictive~     value of and change in muscle quantity and quality in critically ill patients with severe~     respiratory failure requiring veno-venous extracorporeal membrane oxygenation (VV-ECMO).~   "
22704|NCT03269812|"~     To evaluate the outcomes of laparoscopic pull-through concerning constipation, incontinence~     and enterocolitis in comparison of other surgical procedures for treatment of Hirschsprung~     disease.~   "
22705|NCT03269799|"~     Periodontitis patients with uncontrolled type 2 diabetes mellitus will receive non-surgical~     periodontal treatment and then be supplemented with daily 500 mg vitamin C (test group) or~     placebo (control group) for 2 months. Clinical parameters will be retrieved at baseline, at~     the end of week 4 and at the end of week 8.~   "
22708|NCT03269760|"~     The purpose of the study is to investigate the efficacy of sleep medicine in the recovery of~     orthopaedic shoulder arthroplasty patients. We hypothesize that a multimodal sleep pathway~     including non-pharmacological sleep hygiene interventions and the use of zolpidem can improve~     patient sleep, pain control, and subsequent recovery after undergoing total shoulder~     arthroplasty.~   "
22709|NCT03269747|"~     Interventional, Placebo controlled cross-over study to investigate the short-term effects of~     glucocorticoids (prednisone) on human brown adipose tissue.~   "
22710|NCT03269734|"~     This study compares the accuracy of fusion imaging (Fusion Roadmap) versus real-time X-ray~     imaging (Roadmap) during catheterization of supra-aortic trunks of in patients with aneurysms~     or arteriovenous malformations.~   "
22711|NCT03269721|"~     COPD is the third leading cause of combined morbidity, disability, and mortality in the~     United States and is often associated with cognitive impairment. The goal of the proposed~     project is to examine novel pulmonary and vascular physiological mechanisms that contribute~     to structural brain abnormalities and cognitive dysfunction early in the course of COPD. The~     project will generate information to ultimately inform the development of interventions to~     delay or prevent cognitive dysfunction.~   "
22712|NCT03269708|"~     The purpose of this study is to determine whether providing individuals with personalized~     information on cellular aging, including telomere dynamics, will stimulate them to adhere to~     cardiac prevention strategies and improve exercise capacity.~   "
22713|NCT03269695|"~     The purpose of this study is to determine if PF-06687234 is effective and safe as add-on~     therapy to infliximab in subjects with active ulcerative colitis who are not in remission.~   "
22714|NCT03269682|"~     Oculomotor nerve (third cranial nerve or III) palsy is a relatively frequent cause of~     consultation in ophthalmology.~      It may reveal a life-threatening pathology such as aneurysm rupture, pituitary apoplexy, and~     therefore need imaging in emergency. Apart from few extreme emergency situations, MRI of the~     oculomotor tract is the first-line examination required. In our usual clinical practice, we~     noticed in several patients unusual contrast enhancement within the oculomotor nerve on T1~     sequence with gadolinium injection, observed in various locations along the nerve path~     (cavernous and/ or intra-orbital segment).~      This contrast enhancement, could confirm the nerve impairment This study aims to analyse the~     efficiency of a new sequence 3D PD T1 which isotropic spatial resolution less than 1mm, not~     yet described in the literature, to depict this enhancement.~      In patients with ophthalmoplegia involving probably the third cranial nerve, disclosing this~     MRI sign could help (i) to confirm the involvement of the oculomotor nerve and eliminate~     differential diagnoses such as myasthenia (ii) to orientate the etiological diagnosis~     (inflammatory or ischemic origin). This new sequence 3D PD T1 sequence focused on the III~     could thus be systematically included in the usual MRI protocol.~   "
22715|NCT03269669|"~     This randomized phase II trial studies how well obinutuzumab with or without PI3K-delta~     inhibitor TGR-1202, lenalidomide, or combination chemotherapy work in treating patients with~     grade I-IIIa follicular lymphoma that has come back or does not respond to treatment.~     Monoclonal antibodies, such as obinutuzumab, may interfere with the ability of cancer cells~     to grow and spread. PI3K-delta inhibitor TGR-1202 may stop the growth of cancer cells by~     blocking some of the enzymes needed for cell growth. Biological therapies, such as~     lenalidomide, use substances made from living organisms that may stimulate or suppress the~     immune system in different ways and stop cancer cells from growing. Drugs used in~     chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and~     prednisone, work in different ways to stop the growth of cancer cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. It is not yet~     known whether giving obinutuzumab with or without PI3K-delta inhibitor TGR-1202,~     lenalidomide, or combination chemotherapy will work better in treating patients with grade~     I-IIIa follicular lymphoma.~   "
22716|NCT03269656|"~     5764 men and women in Iceland, aged 66 to 96 years entered the Ages Gene/Environment~     Susceptibility (AGES) - Reykjavik Study. Serum 25(OH)D was measured in 5,519 of all 5,764~     (96%) participants at study entry in year 2002 through 2006. The main emphasis was on~     exploring whether pre-diagnostic serum levels of 25(OH)D were associated with survival after~     cancer diagnosis.~   "
22717|NCT03269630|"~     Pulmonary hypertension (PH) is a serious condition characterized by a mean pulmonary artery~     pressure >=25mmHg on right heart catheterization (RHC). Despite advances in PH care, outcomes~     are still sub-optimal and further research is required into the pathobiology of the disease~     and development of biomarkers that can guide clinical care. The investigators are~     establishing a biobank to collect samples (blood, urine, stool) from patients with pulmonary~     hypertension, patients at high risk for pulmonary hypertension, healthy controls, and~     patients undergoing right heart catheterization. Specimens will be stored for future~     investigations.~   "
22718|NCT03269617|"~     The PHAGE study is designed to determine if a commercial prebiotic product can change the~     composition of bacteria in the gut for improved intestinal health. A prebiotic is defined as~     an indigestible dietary component that selectively enhances specific bacterial species in the~     intestines to confer a health benefit. In this study, the prebiotic a unique combination of~     bacteriophages, or viruses that infect bacteria. These phages are generally regarded as safe~     for human consumption and work by infecting bad bacteria in the gut, which allows beneficial~     bacteria populations to increase. The product, PreforPro, has shown to be effective in~     culture-based and animal studies, but its efficacy has not been demonstrated in humans. The~     goal of this study is to see if PreforPro consumption improves gut bacteria profiles in~     individuals relative to a placebo control and is associated with reduced incidence and~     severity of gastrointestinal distress.~   "
22749|NCT03269214|"~     Patients who had bisphosphonate-related osteonecrosis of the jaw in stage II were allocated~     in two groups randomly : In group1, 10 patients underwent debridement and primary closer of~     the area,in group 2 , patients received Phenytoin + tetracycline topically in the debridement~     area.Wound dehiscence , infection and pain were in 1,6 and 12 months after treatment.~   "
22875|NCT03267524|"~     This pilot clinical trial studies how well Walking for Recovery from Surgery works in~     improving quality of life in older adults with lung or gastrointestinal cancer and their~     family caregivers. A walking program, such as Walking for Recovery from Surgery may help~     support overall well-being as a caregiver, and may help improve family member or friend's~     recovery from surgery.~   "
22719|NCT03269604|"~     Asymptomatic bacteriuria (AB) is the isolation of a bacterium in a sample of urine~     appropriately collected from a person who does not have signs or symptoms of urinary~     infection. It is common in diabetic women, in pregnant women, in men over 60 years and in~     patients with spinal cord injury.~      There is clinical evidence that AB should be treated in patients who will be operated on with~     urologic surgery because of the risk of presenting infectious complications; however, the~     timing of initiating antibiotic therapy has not been established, even in some studies the~     prophylaxis has been considered from one to seven days prior to the procedure, without~     determining the differences in the outcome for each one of the interventions and causing an~     undue and risky use of antibiotics.~      A randomized, parallel-design, single-masked clinical trial will be performed to compare and~     analysis the bloodstream infections, surgical site infections, readmissions and hospital stay~     in three intervention groups, 1) those receiving antibiotics during the previous 5 days to~     the procedure; 2) 3 days prior to the procedure; and 3) those who receive only a single dose~     of antibiotic on the day of the procedure.~      The main expected result is to identify the timing of initiation of antibiotic prophylaxis in~     urological procedures in patients with asymptomatic bacteriuria, with the purpose of~     diminishing the bloodstream and of the surgical site infections. If it is scientifically~     demonstrated that those patients who receive a single dose of antibiotic on the same day of~     the procedure, have the same safety and effectiveness compared to the other two groups, would~     reduce hospital stay, surgical waiting time and indiscriminate use of antibiotics that~     generate multidrug-resistant microorganisms, thus generating an impact on Public Health and~     on the quality of care.~   "
22720|NCT03269591|"~     Electromagnetic field versus diclofenac drugs on primary dysmenorrhea: Arandomized controlled~     trial in the Egyptian women~   "
22721|NCT03269578|"~     Background:~      People who join a study in the Developmental Therapeutics Clinic (DTC) have tests. These~     include blood draws and biopsies. Researchers collect data from these samples. Some people~     take part in more than one study at the DTC. At this time, data are connected only with one~     single study. Researchers want to access people s medical records. This will allow them to~     link the research data from all their studies they have or will take part in. Researchers~     also want to collect medical data about their diagnosis and treatment history. This will~     allow them to see how their cancer reacted to different drugs over time.~      Objective:~      To enter people into a master protocol to connect research sample and treatment data across~     DTC studies.~      Eligibility:~      People ages 18 and older who are being evaluated or treated for cancer in the DTC~      Design:~      Participants will allow researchers to look at all the data from their research samples. This~     includes those from their current, past, and any future NIH studies.~      Participants will allow researchers to access some of their medical data. This includes age,~     diagnosis, treatment history, and response to treatment.~      Participants will provide no new samples.~   "
22722|NCT03269565|"~     An International Multicenter Open-label Randomized Trial of the Efficacy, Pharmacokinetics,~     Safety, and Immunogenicity of BCD-100 (JSC BIOCAD, Russia) as Monotherapy in Patients with~     Unresectable/Metastatic Melanoma.~   "
22723|NCT03269552|"~     This phase II trial studies how well carfilzomib with or without rituximab work in treating~     patients with Waldenstrom macroglobulinemia or marginal zone lymphoma that is previously~     untreated, has come back, or does not respond to treatment. Carfilzomib may stop the growth~     of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal~     antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and~     spread. Giving carfilzomib alone when disease is responding or with rituximab when disease is~     not responding may work better in treating patients with Waldenstrom macroglobulinemia or~     marginal zone lymphoma.~   "
22724|NCT03269539|"~     Our main approach in this research is to collect MR data using both a Routine and Fast~     brain protocol on the 3 Tesla Siemens Skyra scanner using a 20-Channel Head/Neck Coil to~     determine if the Fast protocol can collect data in less time without compromising patient~     care.~   "
22725|NCT03269526|"~     This protocol will confirm toxicities and estimate the clinical efficacy of combining~     anti-CD3 x anti-EGFR bispecific antibody (EGFRBi) armed activated T cells (EGFR BATs) given~     to patients with locally advanced or metastatic pancreatic cancer who have received at least~     one dose of first line chemotherapy and may have responding, stable or progressive disease.~     Phase Ib will confirm a safe dose of 8 infusions, given twice weekly, of EGFR-BATs in 3 to 6~     subjects. The phase II portion of the trial will test the clinical efficacy of this dose in~     22 patients (including those in Phase Ib).~   "
22726|NCT03269513|"~     The study aims to evaluate the possible effects of an exercise program, nutritional and~     psychological, postural orientation and guidance of oral health on body composition, physical~     activity levels and lifestyle, physical fitness and health and motor performance, the factors~     risk of cardiovascular disease, eating habits, the cognition levels, the psychological~     profile, the body posture of children and adolescent with overweight and obesity, considering~     the presence of risk genotype associated with the development of obesity. In addition,~     identify the effects of orientation for oral health on the quality of life and healthy oral~     habits.~   "
22727|NCT03269500|"~     Describe the frequency of use of nutrition education tools for undernourished older people~   "
22728|NCT03269487|"~     This study is part of the 5-year long (2013-18) PERFECTED (Peri-operative Enhanced Recovery~     hip-fracture Care of paTiEnts with Dementia) National Institute for Health Research (NIHR)~     funded research programme.~      PERFECTED's aim is to develop and pilot an evidence-based intervention to improve the~     hospital care of patients living with dementia who have fractured their hip. This protocol~     relates to Work Package 2 (WP2) of PERFECTED only.~      By working collaboratively with local clinicians and stakeholders, an action research~     (plan-do-study-act) approach will be used to generate knowledge to understand how to best~     implement the intervention (PERFECTED Enhanced Recovery Pathway), which was developed from~     learning and research undertaken as part of Work Package 1. During the current study the~     PERFECTED Enhanced Recovery Pathway (ERP) will be used to optimise care on three~     ortho-geriatric wards for 12 months. These wards are located in Norfolk, Nottinghamshire and~     Yorkshire. The sole participants are NHS personnel delivering care on selected wards.~      Data collection activities (observations, in-field interviews, documentary analysis and~     quantitative data generated from the PERFECTED ERP implementation checklist) will determine~     the staff training and cultural changes required to implement and maximise adherence to the~     PERFECTED ERP. Simultaneously, enabling the identification and exploration of areas of~     optimised, satisfactory and sub-optimal care. By working in partnership within and across the~     partner wards, action plans to address sub-optimal care will be generated, implemented and~     reviewed. Findings will inform the best ways to optimise care via the implementation of the~     PERFECTED ERP. Knowledge generated during this study will be used to develop an ERP and staff~     training manual. This will aid implementation of the intervention arm of a latter Cluster~     Randomised Control Trial (Work Package 3), ensuring the PERFECTED ERP can be utilised in the~     real world.~      As part of PERFECTED's commitment to Public Patient Involvement (PPI), lay researchers will~     be trained to assist with qualitative research activities.~   "
22761|NCT03269045|"~     An Open-label, Single-arm, Phase 2 Study of Biotin in Patients With Biotinidase Deficiency.~   "
22762|NCT03269032|"~     This study will evaluate the impact of a Mediterranean-style diet on microbiome diversity~     compared to a typical American diet. The study will observe the microbiome composition~     comparisons in healthy volunteers as well as in patients with Irritable Bowel Syndrome with~     Diarrhea (IBS-D) to see if the consumption of a Mediterranean-style diet has a positive~     effect on improving symptoms of IBS-D.~   "
22729|NCT03269474|"~     The study will compare gene expression differences between blistered and non-blistered skin~     from individuals with EBS, as well as normal skin from non-EBS subjects. State of the art~     computational analysis will be performed to help identify new drugs that might help EBS wound~     healing and reduce pain. Researchers will focus on drugs that have already been approved for~     treatment of other dermatologic or non-dermatologic diseases, and therefore be repurposed for~     treatment of EBS. Drug development is a very expensive process taking decades for execution.~     Drug repurposing on the other hand, significantly reduces the cost and shortens the amount of~     time that is needed to bring effective treatments to clinical use. To date, there is no~     specific treatment targeting the physiology and immunologic response in EB patients during~     wound healing. Market availability of repurposed medications will provide EBS patients rapid~     access to treatments, thus improving their quality of life.~   "
22730|NCT03269461|"~     Prospective, multicentric, single-arm study to evaluate fast and effective tissue repair in~     patients undergone percutaneous coronary intervention with drug eluting stent Inspiron.~   "
22731|NCT03269448|"~     Observational study to analyze correlation between partial pressure of carbon dioxide from~     blood obtained from peripheral and central veins~   "
22732|NCT03269435|"~     We are comparing a type of nerve block called greater occipital nerve block versus standard~     therapy among patients who present to an emergency department for acute migraine. This is a~     randomized, double-blind, double dummy study. The greater occipital nerve block will be~     performed bilaterally with bupivacaine 0.5%. Standard therapy is metoclopramide 10mg IV.~   "
22733|NCT03269422|"~     The purpose of the study is to find out the feasibility and effects of ultra-hypofractionated~     radiotherapy to the prostate and dominant lesion as definitive treatment for intermediate~     risk prostrate cancer.~   "
22734|NCT03269409|"~     This randomized clinical trial aims to determine if cells from a patient's own adipose tissue~     is safe and capable of helping regenerate the femoral head in patients with osteonecrosis.~     The standard of care is known as hip decompression which simply removes dead tissue from the~     femoral head and creates a new cavity to be filled in by healthy bone. This trial will use~     hip decompression plus saline injection in one hip and hip decompression supplemented with~     adipose derived regenerative cells in patients with osteonecrosis in both of their hips.~   "
22735|NCT03269396|"~     The purpose of this proposed study is to obtain safety and efficacy data on human laryngeal~     allograft transplantation in an effort to safely use these procedures as a viable~     reconstructive option for patients with severe laryngeal or laryngotracheal incompetence.~   "
22736|NCT03269383|"~     Atrial fibrillation requires both an initiation trigger and favorable environment for~     maintenance and the sympathetic and parasympathetic nervous systems play important roles in~     this regard. Unfortunately, the precise mechanisms of post operative atrial fibrillation~     (POAF) are still being investigated. This postoperative complication has persisted in spite~     of efforts to mitigate it pharmacologically with beta blockers and amiodarone, an experience~     shared by most other cardiac surgery centers.~      The stellate ganglion is formed by the fusion of the inferior cervical sympathetic ganglion~     and first thoracic sympathetic ganglion. By modulating the sympathetic component of the~     autonomic nervous system, stellate ganglion stimulation has been shown to facilitate~     induction of atrial fibrillation while ablation may reduce or prevent episodes. Human studies~     have further supported this model.~      Preliminary studies of perioperative stellate ganglion block (SGB) in cardiac surgery suggest~     that this technique may reduce or prevent episodes of POAF requiring treatment. The~     investigator's hypothesis is that SGB reduces the incidence of POAF in cardiac surgery~     populations.~   "
22737|NCT03269370|"~     Anxiety disorders are among the most common psychological disorders, with prevalent onset in~     childhood and adolescence. While cognitive behavioral therapy (CBT) is considered the~     first-line treatment for pediatric anxiety, significant barriers remain in accessing CBT and~     other evidence-based treatments (EBTs), and credible self-help resources based in EBT~     concepts. This study evaluates a family-guided CBT game application (Anchors App), targeted~     to children ages 6-11 and their families, which focuses on delivering adaptive CBT-based~     coping skills to those who have sub-clinical to mild anxiety and related symptoms in a~     convenient and portable platform. Anchors App will be evaluated in two forms (standard and~     parent-enhanced) in comparison to use of a self-help book or waitlist control. The rapid~     advancements in technology allows richer interactive capacity, content scalability,~     customizability, and subscription to a broader range of content, which this app capitalizes~     on in order to increase access to CBT skill concepts directly to pediatric stakeholder~     populations. If found to be effective, Anchors App has the opportunity to promote engagement~     of EBT concepts in every-day use through smartphone technology, and will change the landscape~     of mental health prevention and early intervention for children and families.~   "
22738|NCT03269357|"~     Training of health care providers and structured LARC forward counseling may contribute to~     increased LARC uptake. The hypothesis to be tested is that by introducing LARC forward~     counselling an increase in LARC usage will be the result as well as decreased unplanned~     pregnancy and abortion. It is expected that the results of this study will highlight the~     importance of LARC forward counseling and thus provide the evidence needed to train health~     care providers and increase access to LARC in youth clinics, midwifery clinics and for post~     abortion contraception.~   "
22739|NCT03269344|"~     Strategies to minimize and mitigate external beam radiation therapy related mucositis and~     pain during the treatment of head and neck cancer remain limited. The investigators~     hypothesize that gabapentin could be used to delay or reduce treatment-related pain, reliance~     on opioid medication, and improve the quality of life for these patients.~   "
22763|NCT03269019|"~     Heparin induced thrombocytopenia (HIT) is a kind of catastrophic thrombotic complications~     after the application of heparin. If HIT without treatment, death rate is as high as 30% to~     50%. Early diagnosis of HIT and prevention of thrombosis is very important.~      This study is planned to assess the use of thrombotic biomarkers in patients with HIT,~     including thrombin-antithrombin complex, d-dimer, fibrin degradation products and~     Thrombelastograghy monitoring . These biomarkers are monitored in 5-14 days post-operation to~     assess the risk of thrombosis in HIT patients. All patients were followed up for 30 days, and~     clinical outcomes, including new thrombus and death, were recorded during follow-up.~   "
22740|NCT03269331|"~     The Institute of Medicine's (IOM) ambitious goal for at least 90% of clinical decisions to be~     evidence-based includes nursing interventions and practice. Models and frameworks have been~     developed to meet the demand for practice transformation. While magnet facilities require a~     commitment to evidence-based nursing practice, military facilities currently lack such a~     requirement but are instituting evidence-based practice (EBP) initiatives in a purposeful~     path toward developing high-reliability organizations. Currently, little is known regarding~     the effectiveness of specific EBP models and frameworks within the military culture. The~     purpose of this investigation is to determine the effectiveness of the Advancing Research and~     Clinical Practice through Close Collaboration (ARCC) model in an Air Force Medical Treatment~     Facility (MTF) beginning with nursing services.~      Research questions:~        1. What is the current state of organizational culture and readiness for EBP within the~          MTF's nursing services?~        2. Will utilization of the ARCC model significantly improve EBP beliefs, knowledge, and~          practice in MTF nurses over a two-year period?~        3. Is the ARCC model feasible for implementation in Air Force MTF's?~      This study includes an intervention group (n=70) of active duty nurses and technicians who~     attend an intensive 5-day EBP Immersion Workshop and a control group (n=70) who do not. The~     intervention group will have access to specialized resources such as: a) Center for~     Transdisciplinary Evidence-Based Practice (CTEP) expert EBP mentors, b) EBP toolkit and~     resources, c) one year of free access to the Ohio State University (OSU) virtual library.~     Control group participants will have standard MTF education opportunities. Established valid~     and reliable survey measures (EBP attitudes, knowledge, beliefs) will be hosted~     electronically by CTEP at baseline, three, and twelve months. Online measures include~     institutional and nursing process measures (EBP implementation, policy changes, and~     publications) over the two-year study period. De-identified data from the anonymous survey~     measures will be shared by CTEP with this study team. Data analysis will include T-tests or~     Mann Whitney U test for group comparisons. Repeated measures ANOVA or the nonparametric~     equivalent, Friedman's test will be used to compare three time points within groups.~     Feasibility metrics and demographics will be reported with descriptive statistics.~   "
22741|NCT03269318|"~     Asthma is one of the most common chronic diseases affecting children in the UK. Poorly~     controlled asthma manifests with chronic cough, wheeze and shortness of breath which in-turn~     has a significant negative impact on a child's quality of life, interfering with sleep,~     impairing exercise ability and resulting in frequent school absences and hospital admissions.~      Management of paediatric asthma in the UK is directed by the British Thoracic Society (BTS)~     Guidelines, which recommend a stepwise (one to five) treatment plan. Step three of the~     management guideline for children aged 5-12 years of age recommends the addition of the~     preventer inhaled medication, including long-acting β2 agonists such as salmeterol. However,~     there is a wide variation in response to this medication with approximately one in seven~     people, with a specific genetic change, found to have an increase in asthma symptoms in~     association with the use of thisiss medication. A related medicine, formoterol, is used less~     commonly in children with asthma.~      In this study, the investigators will aim to identify children with asthma whose symptoms are~     poorly controlled on inhaled long-acting beta2 agonists. Via a simple saliva test, the~     investigators will identify the presence or absence of the specific genetic change potentally~     influencing the effectiveness of treatment with salmeterol or related longacting beta2~     agonists thus enabling the investigators to recommend either salmeterol or an alternative~     medication for the treatment plan such as montelukast. The investigators will randomise the~     patients into two groups; to receive personalised care where the choice of controller~     medication would be based on the child's gene test results and predicted response to~     long-acting beta2 agonists, or standard care following the BTS guidelines at the~     clinician's discretion without knowledge of the gene test results. The investigators aim to~     measure whether this individualized approach to asthma prescribing results in improved~     control of asthma symptoms and overall quality of life. Targeting treatment to a child's~     specific genetic make-up is a concept known as personalised medicine.~   "
22742|NCT03269305|"~     The study is to assess whether the staff in gastroenterology unit are sticking to the agreed~     up on unit's protocol in management of chronic diarrhea over the period of one year(september~     2017-september 2018)~   "
22743|NCT03269292|"~     Autoimmune hemolytic anemia is characterized by shortened red blood cell survival and a~     positive Coombs test. The responsible autoantibodies may be either warm reactive or cold~     reactive. The rate of hemolysis and the severity of the anemia may vary from mild to severe~     and life-threatening. Diagnosis is made in the laboratory by the findings of anemia,~     reticulocytosis, a positive Coombs test, and specific serologic tests. The prognosis is~     generally good but renal failure and death sometimes occur, especially in cases mediated by~     drugs.~   "
22744|NCT03269279|"~     The goal of this study is to examine the effectiveness and feasibility of a~     mifepristone-misoprostol medical abortion regimen in terminating pregnancies 13-22 weeks in~     Burkina Faso.~   "
22745|NCT03269266|"~     Fever is one of most common presenting complaints in clinics in tropical countries.~     Rickettsial infections, enteric fever and leptospirosis are common and important causes of~     undifferentiated fever in Southeast Asia. Scrub typhus is caused by Orientia tsutsugamushi~     and humans are typically infected by a bite of an infected chigger (trombiculid mite larva).~     Clinical diagnosis is unreliable for identifying scrub typhus, unless a tick eschar is~     present which is almost pathognomonic for the disease in Southeast Asia. A combination of~     culture, paired serology and PCR has been proposed as the gold-standard method for detection.~     As a result laboratory confirmation is not widely available and the diagnosis is missed~     frequently in clinical practice. Some progress has been made in developing such a test and~     one promising candidate is the Scrub Typhus Detect IgM Rapid Test (InBios International Inc).~     We plan to use to this test in this study to estimate the prevalence of scrub typhus in~     selected febrile patients presenting to clinics in Myanmar .~      Patients will be followed up for one week to check for resolution of symptoms.~   "
22746|NCT03269253|"~     This study focused on investigating the effects of maternal disordered eating on maternal and~     child outcomes as part of a secondary data analysis of the Avon Longitudinal Study of Parents~     and Children (ALSPAC).~   "
22747|NCT03269240|"~     The aim of this study is to compare the effectiveness and cost of a simulation-based low dose~     high frequency (LDHF) plus m-Mentoring training versus the traditional group-based training~     approaches in improving knowledge and skill in maternal and newborn care and to determine~     trainees' satisfaction with the approaches in Ebonyi and Kogi states.~      The specific objectives are to:~        1. Compare knowledge and skill learning outcomes between the two groups of birth attendants~          trained through the simulation-based LDHF/m-Mentoring versus group-based training~          approaches in Kogi and Ebonyi states over 12-months.~        2. Assess the trainees' satisfaction with a simulation-based LDHF/m-Mentoring and~          group-based training approaches in improving skills of birth attendants in the selected~          facilities in Kogi and Ebonyi state over 12-months.~        3. Determine the cost and cost-effectiveness of LDHF/m-Mentoring and group-based training~          approaches in improving skills of birth attendants in the selected facilities in Kogi~          and Ebonyi state over 12-months.~   "
22748|NCT03269227|"~     This is a monocentric prospective study of radiotherapy using accelerated hypofractionation~     with Tomotherapy in Malignant Pleural Mesothelioma (MPM) patients after pleurectomy /~     decortication (P / D) or biopsy.~      The treatment will be delivered using Tomotherapy, that allows to adopt dose accelerated~     hypofraction criteria. Treatment duration is 5 consecutive days.~   "
22776|NCT03268850|"~     This study aims to evaluate the effectiveness of offering reimbursement for living donor lost~     wages on the rate of live donor kidney transplantation.~   "
22750|NCT03269201|"~     The diagnosis and management of movement disorders, such as Parkinson's disease (PD),~     parkinson-plus syndromes (PPS), dystonia, essential tremor (ET), normal pressure~     hydrocephalus (NPH) and others is challenging given the lack of objective diagnostic and~     monitoring tools with high sensitivity and specificity. A cornerstone in research of~     neurological disorders manifesting as MDi is the investigation of neurophysiological changes~     as potential biomarkers that could help in diagnosis, monitoring disease progression and~     response to therapies. Such a neuro-marker that would overcome the major disadvantages of~     clinical questionnaires and rating scales (such as the Unified Parkinson's disease rating~     scale -UPDRS, for PD, The Essential Tremor Rating Assessment Scale -TETRAS, for ET and~     others), including low test-retest repeatability and subjective judgment of different raters,~     would have real impact on disease diagnosis and choice of interventions and monitoring of~     effects of novel therapeutics, including disease modifying therapies.~      To address this, ElMindA has developed over the last decade a non-invasive, low-cost~     technology named Brain Network Activation (BNA), which is a new imaging approach that can~     detect changes in brain activity and functional connectivity. Results from proof-of concept~     studies on PD patients have demonstrated that: 1) PD patients exhibited a significant~     decrease in BNA scores relatively to healthy controls; 2) notable changes in functional~     network activity in correlation with different dopamine-agonist doses; 3) significant~     correlation between BNA score and the UPDRS). 4) BNA could also differentiate early PD from~     healthy controls~   "
22751|NCT03269188|"~     prospective cohort study of women who underwent caesarean section in mulago hospital.~     followed up for 2 months and assessed for development of persistent post operative pain at~     the incision site and its effect on quality of life. incidence of persistent postoperative~     pain and associated factors determined.~   "
22752|NCT03269175|"~     The purpose of this study is to obtain long-term clinical data from patients approximately 15~     years after their first clinical event, who participated in the former BENEFIT 304747 study~     and were treated at least once within that study.~      This study will collect clinical information on the disease course, on disability, relapses,~     cognitive function over time, quality of life, depression, fatigue, resource use, and~     employment status. In addition, brain MRI is performed.~   "
22753|NCT03269162|"~     Objective: To study the effect of Jinfukang Koufuye combined with chemotherapy on preventing~     relapse and metastasis of early postoperative NSCLC patients. Method: In this~     multicenter、prospective、randomized controlled clinical trial, 144 NSCLC patients with~     complete resection、stage Ib-IIb were randomly divided into Jinfukang Koufuye combined with~     chemotherapy group (treatment group, N=72) and chemotherapy only group (controlled group,~     N=72). Peripheral blood CTCs and immune cells were detect on five different time points:~     after operation、4 chemotherapy cycles were over、12 months after operation、18 months after~     operation、and 24 months after operation. To evaluate the effect of Jinfukang Koufuye combined~     with chemotherapy on the level of peripheral blood CTCs、DFS、immune function、quality of life~     of postoperative patients; and decreasing the side effect of chemotherapy.~   "
22754|NCT03269149|"~     The goal of the project is to determine the extent to which indices of inflammatory~     biomarkers, cognition and mood, are influenced by a partnered, dance-based intervention vs~     control condition in African American (AA) female family caregivers, at high risk for~     Alzheimer's disease (AD).~   "
22755|NCT03269136|"~     To assess the safety and tolerability at increasing dose levels of PF-06863135 in patients~     with relapse/ refractory multiple myeloma in order to determine the maximum tolerated dose~     and select the recommended Phase 2 dose.~   "
22756|NCT03269123|"~     Idiopathic blepharospasm (IB) is a rare but well characterised adult onset focal dystonia~     that may cause severe visual disability. The most effective treatment is with periodic~     injections of botulinum toxin into the pre-tarsal and / or pre-septal orbicularis oculi~     muscles bilaterally. However, even with treatment, practical visual function often remains~     compromised.~      A subset of IB sufferers find that eye opening improves with focal unilateral digital~     pressure usually on a specific point on the temple. The Investigators have developed a~     spectacle mounted spring-loaded prosthesis (the Pressop device) to apply continuous~     individually localised focal pressure on the temple to mimic the effect of finger pressure.~      The Investigators recommended a trial of this simple safe device in those IB patients who~     report improvement in eye opening with focal digital temple pressure.~   "
22757|NCT03269110|"~     FACT 4 Child is a follow up study of mothers who participated in the Folic Acid Clinical~     Trial (NCT01355159) and their children at 4-6 years of age to determine the effect of high~     dose folic acid supplementation on social impairments associated with Autism Spectrum~     Disorders (ASDs), and deficiencies in a range of executive function and emotional and~     behavioural problems in young children, and the risk of death.~   "
22758|NCT03269084|"~     The Type 1 Diabetes Prediction and Prevention (DIPP) Study in Finland is a population-based~     long-term clinical follow-up study established since 1994 in three university hospitals in~     Finland to understand the pathogenesis of type 1 diabetes (T1D), predict the disease, and~     find preventive treatment.~   "
22759|NCT03269071|"~     This is a phase I study evaluating the feasibility, safety and tolerability of intrathecally~     administered human Neural Stem Cells (hNSCs), at an escalating dose ranging from 0.7x10^6±10%~     cells to 5.7x10^6±10% cells/kg of body weight, in patients affected by Progressive Multiple~     Sclerosis~   "
22760|NCT03269058|"~     This study will make it possible to better understand the mechanisms responsible for the~     increase in bad cholesterol levels observed in patients with type 2 diabetes treated with~     Dapagliflozin, an antidiabetic treatment made by Astrazeneca.~      The information will:~        -  reveal what is not working properly~        -  make it possible to choose the most appropriate treatments against cholesterol to~          compensate for this impaired functioning~      This biomedical research will take place at the University Hospitals of DIJON and NANTES.~        -  28 patients will take part: 20 patients will be given Dapagliflozin and 8 patients will~          be given the placebo.~        -  The study treatment will be randomised: patients will be given either Dapagliflozin or~          the placebo. The treatment duration is 6 months.~        -  Moreover, during the inclusion visit and at the end of the study (6 months after the~          start of treatment), a kinetics study, to follow the production and elimination of~          cholesterol, will be conducted. This will involve administering amino acids that have~          been specifically synthesised for this purpose.~        -  Participation in the study will last 6 months and include 4 protocol visits.~   "
22764|NCT03269006|"~     Visceral leishmaniasis (VL) also known as kala-azar is a public health problem in Bangladesh.~     Since 2005 a national kala-azar elimination program is going on in the country. The program~     has preparatory, attack, consolidation and maintenance phases. The target of the program is~     to reduce the VL incidence less than 1 per 10,000 people at upazila (sub-district) level in~     VL endemic upazilas of the country. The program is heading successfully to its consolidation~     phase.~      During attack phase house to house search for VL suspects and also suspects with~     Post-kala-azar Dermal Leishmaniasis (PKDL) was the tool for early diagnosis of VL and PKDL~     cases. Indoor residual spraying with insecticide (Deltamethrin) was the method for sand fly~     control to reduce the transmission of the disease. Since in the consolidation phase the VL~     case load is many times less than that in the attack phase, house to house search for VL and~     PKDL cases and IRS for vector control is no more cost-effective for the program. Therefore~     there is a need for alternative methods for active search of VL and PKDL cases and method for~     sand fly control, appropriate for the consolidation phase.~      In the present study the investigators propose to investigate the efficacy of Inesfly 5AIGRNG~     TM containing Alphacypermethrin 0.7%; D-Allethin 1.0% and Pyriproxyphen (0.063%), commercial~     available durable wall lining (DWL), impregnated of existing bed-net with insecticide tablet,~     KO TAB 123, indoor residual spraying (IRS) with Delthamethrin against a control group~     Methods: A cluster randomized controlled design to measure sand fly density reduction at~     intervention household as well as sand fly mortality by entomological methods.~      Outcome measures/variables: reduction of sand fly density at intervention household and sand~     fly corrected mortality on intervention surfaces compare to control households/conditions.~   "
22765|NCT03268993|"~     Avmacol is an over-the-counter dietary supplement containing broccoli seed and sprout~     extracts in tablet form, hypothesized to activate protective cellular pathways including~     detoxication. In this study, participants who have been curatively treatment for head and~     neck cancer, will take Avmacol twice a day for 3 months~   "
22766|NCT03268980|"~     -  Tobacco is the leading risk factor for avoidable mortality in France and around the~          world. It is also the second cause of life with disability in the world and the leading~          preventable risk factor for cancer in France and worldwide.~        -  The Health Barometer studies carried out for 25 years in France by Santé-Publique~          France assessed prevalence of smoking in the lay population. These studies showed that~          smoking prevalence has stabilized among 15-75 year olds (34.1% of current smokers) with~          a slight decrease in regular smoking (from 29.1% in 2010 to 28.2% in 2014).~        -  Data on the prevalence of smoking among hospital staff are contradictory. Some studies~          find a higher prevalence of active smoking than the general population; others have a~          lower prevalence. However, it appears that an active prevention policy with hospital~          staff can significantly and rapidly reduce the prevalence of active smoking.~        -  The prevalence of active smoking in patients is logically higher than in the general~          population (at comparable age).~        -  The data on the prevalence of smoking among medical students are also contradictory.~          Yet, this population is a special interest group given their future investment in~          patient care.~        -  Cannabis use also appears to be an independent risk factor for respiratory diseases and~          broncho-pulmonary cancers. Cannabis use among health students is not uncommon (11.5% of~          students). To our knowledge, the measurement of the prevalence of Cannabis use in an~          all-patient population of a hospital-university facility has never been achieved.~        -  According to the health barometer 2014, about a quarter of 15-75 year olds have already~          tried electronic cigarettes and 6% are regular current users. Although the toxicity of~          the electronic cigarette and its interest in weaning remain controversial, its use to~          patients, staff or patients has been reported very little.~      The aim of this study is to assess the impact of collective and individual tobacco control~     measures by measuring the prevalence of smoking on a given day at the Hospices Civils de~     Lyon, among patients, staff and students present on a given day initially and 5 years later.~   "
22767|NCT03268967|"~     Admission to the intensive care unit (ICU) is vital for surviving critical illness. An~     admission to ICU without having a consistent structure, structured review of the patient and~     a solid team organization lead to unclear communication and responsibility. Factors that~     correlate with patient acceptance and safety, morbidity and mortality. The hypothesize was~     that a structured admission can improve patients safety, reduce delays in treatment, reduce~     ICU length of stay, and improve mortality rate. The overall objective was to optimize patient~     safety, and effectively use available resources to reduce admission time, delays in treatment~     and procedures and mortality by using both quantitative and qualitative methods.~   "
22768|NCT03268954|"~     The purpose of this study is to determine whether the combination of pevonedistat and~     azacitidine improves overall response rate (ORR) by Cycle 6 and whether the combination of~     pevonedistat and azacitidine improves event-free survival (EFS) when compared with~     single-agent azacitidine.~   "
22769|NCT03268941|"~     The purpose of this study is to evaluate the safety, PK and PD of TAK-906 in participants~     with Gastroparesis (GP).~   "
22770|NCT03268928|"~     The aim of this project is to evaluate whether Beanstalk's 'Story Starters' intervention is~     effective in boosting vocabulary and grammatical development in young children.~   "
22771|NCT03268915|"~     This study is designed to evaluate the reproductibility and the performance of the 3 minutes~     sit-to-stand test in patients with idiopathic pulmonary fibrosis.~      To do this, the investigators are recruiting 40 patients with idiopathic pulmonary fibrosis~     in 2 centers (Grenoble university hospital and Lyon university hospital).~      Patients had to achieve an effort test on a cycle ergometer. 2 visits are planned in the~     hospital. During each visit, patients will perform a 3 minutes sit-to-stand test, a 1 minute~     sit-to-stand test and a 6 minutes walk test. During the second visit, patients will also~     perform a 3 minutes sit-to-stand test with measurement of oxygen uptake.~      The investigators will then analyse the results by comparing numbers of cycle, functional~     response and symptoms during the 3 minutes sit-to-stand test of the 2 visits. The~     investigators will also compare the functional response obtained during the 3 minutes~     sit-to-stand test, the 1 minute sit-to-stand test and the 6 minutes walk test.~      Finally, the investigators will compare the maximal values of oxygen uptake, respiration rate~     and expired volume obtained during the 3 minutes sit-to-stand test to the effort test on~     cycle ergometer.~   "
22772|NCT03268902|"~     This study aims to assess growth and cognitive effects of treatment with azithromycin and~     nitazoxanide and/or nicotinamide (vitamin B3) supplementation nicotinamide.~   "
22773|NCT03268889|"~     This study evaluates the efficacy and safety of Chidamide plus CHOP regimen for de novo PTCL~     patients.~   "
22774|NCT03268876|"~     Based on an improved understanding of how the extent of successful cytoreduction is~     influenced both by inherent tumor biological characteristics as well as the aggressiveness of~     the surgical approach this project aims to better define the value of cytoreduction and to~     use the knowledge gained to develop more individualized therapy and follow-up. This will be~     achieved through a translational biomedical research approach. Due to the research group's~     traditions clinical phenotyping, biomarker identification, and clinical trials will be the~     focus.~   "
22775|NCT03268863|"~     This study is testing whether or not low-cost, virtual reality (VR) headsets for mobile~     phones can be used as a potential distractor from pain and thus would have clinical~     applications as a low-cost, non-pharmaceutical method to increase pain tolerance in patients~     undergoing painful or uncomfortable procedures. To do this, the investigators are asking~     volunteers to submerge their hand up to the wrist in cold water (Cold Pressor Test), either~     while playing an interactive virtual reality game on the headset, or while wearing a VR~     headset that is turned off as a control. The investigators will record the participants'~     tolerance to cold water as measured by how long the participants are able to keep their hand~     in the cold water.~   "
22777|NCT03268837|"~     Local anesthetics are often given in a continuous fashion to block specific nerves after an~     operation for pain control. A new infusion strategy named the 'programmed intermittent bolus'~     (PIB) technique delivers the hourly dose within minutes compared to the traditional infusion~     that delivers such dose over an hour. The PIB technique has demonstrated superior patient~     satisfaction and reduced local anesthetic consumption when utilized for pain control during~     labour and delivery. However, it is not known if the PIB technique gives any benefits during~     a continuous nerve block in other settings. The aim of this randomized controlled trial (RCT)~     is to elucidate if PIB is better than (traditional) continuous infusion for postoperative~     analgesia in patients receiving a continuous nerve block for total shoulder arthroplasty with~     respect to pain control.~   "
22778|NCT03268824|"~     Focal epilepsy is associated with widespread alterations in structural brain connectivity,~     often present at the disease onset and related to learning disabilities. Whether ongoing~     seizure activity contributes to network pathology is a matter of debate. This study intends~     to measure the impact of seizures on structural connectivity on a local and on a global~     level. In children examined with intracerebral electrodes to evaluate whether a surgical cure~     can be proposed, we combine intracerebral stereotactic electroencephalography (EEG)~     recordings with diffusion weighted imaging of white matter fibers. On the local level, the~     study will quantify the number of deficient connections in the seizure onset zone. On a~     global level, the study will compare the white matter fibers of the left and right hemisphere~     to probe whether physiological language lateralization is preserved.~   "
22779|NCT03268811|"~     A study in Japanese Children with Short Bowel Syndrome Who Completed SHP633-302~   "
22780|NCT03268798|"~     Following stroke, muscle weakness and impaired motor function are expressed in both the more~     (MA; paretic) and less affected (LA; non-paretic) sides. Although the efficacy of resistance~     training is well recognized, training the MA limb directly may be initially difficult due to~     muscular weakness. Cross-education is training one side of the body increases strength in~     the untrained and opposite side. This concept can be applied in strength training when~     training the more affected sides cannot be initiated. Recently, our lab found six weeks of~     dorsiflexion resistance training in the LA leg improved the strength of both trained and~     untrained legs of chronic stroke participants.~      The current project explored if cross-education exists in the upper limb in chronic stroke~     participants and if there are related changes in cortical and spinal cord plasticity. We~     hypothesized that unilateral strength in the less affected arm could enhance wrist extension~     strength bilaterally with related neural adoption and improved clinical function.~   "
22781|NCT03268785|"~     During surgery, a fine needle puncture was proceeded when suspicious nodes was found by~     clinician. Repeat the punction for 2-3 times from different orientation and then, Diff-quik~     staining or PTH immunochromatographic assay were proceeded for lymph node or parathyroid~     glands identification. Post-operative pathology outcome was considered as golden standard.~   "
22782|NCT03268772|"~     This study is designed to evaluate the efficacy and safety of pegylated liposomal doxorubicin~     (PLD) combined with ifosfamide (IFO) for the first-line treatment of patients with advanced~     or metastatic soft tissue sarcoma (STS).~   "
22783|NCT03268759|"~     Reward processing will be examined in prenatally exposed emerging adults in a longitudinal~     design. Participants will be followed for one year to see if neural markers of reward~     processing prospectively predict risk-taking behavior.~   "
22784|NCT03268733|"~     An open clinical trial~   "
22785|NCT03268720|"~     Patients with non-celiac gluten sensitivity (NCGS) complain about gastrointestinal and~     extraintestinal symptoms while consuming gluten-containing cereals. The symptoms strictly~     correlate with ingestion of gluten-containing cereals and disappear quickly under elimination~     diets. Till now, there are no specific markers to diagnose NCGS. This study aims to determine~     the effect of a low FODMAP diet (fermentable oligo-, di- and monosaccharides and polyols) and~     a glutenfree diet on the mucosal immunity, clinical symptoms, and psychological well-being.~     Furthermore, the influence of the diets on the microbiome will be analyzed.~   "
22786|NCT03268707|"~     A randomized, open, mono-centric pilot study to investigate the influence of an innovative~     telemetric smartphone application on re-hospitalization and quality of life after cryoballoon~     pulmonary vein isolation in patients with paroxysmal atrial fibrillation.~   "
22787|NCT03268694|"~     Purpose: To investigate the electrophysiological correlates of human cognition and affective~     processing. Participants: Drug-resistant epilepsy patients undergoing epilepsy surgery~     cortical mapping with continuous electrocorticography (ECoG) with intracranial electrodes.~     Procedures (methods): Participants will perform computer-based cognitive and affective~     processing tasks during routine long-term monitoring. Intracranial EEG will be collected~     during the task~   "
22788|NCT03268681|"~     Biotinidase is an enzyme that recycles biotin, a water-soluble vitamin essential as a~     coenzyme for four carboxylases that are involved in gluconeogenesis, fatty acid synthesis,~     and in the catabolism of several branch-chain amino acids. Biotinidase deficiency (BD) is an~     autosomal recessively inherited disorder. Patients with profound BD (<10% of mean normal~     serum biotinidase activity) presents, usually during early childhood, with neurological~     (seizures, hypotonia, ataxia, developmental delay, vision problems, and/or hearing loss) and~     non-neurological findings (metabolic acidosis, respiratory difficulties, alopecia and/or skin~     rash) that may progress to coma or death if untreated.~      Three cases of adult-onset biotinidase deficiency with reversible optic neuropathy have~     recently been described in France, where there is no neonatal screening of BP. Once treated~     with Biotin, patients' vision was fully restored.~      This study aims to assess the prevalence of BP among a population of patients with idiopathic~     optic neuropathy, and to assess the efficacy of Biotin supplementation on visual impairment~     in these patients.~   "
22798|NCT03268551|"~     The study will examine how medical cannabis use affects opioid analgesic use over time, with~     particular attention to THC/CBD content, HIV outcomes, and severe adverse events.~   "
22876|NCT03267511|"~     The purpose of this study is to determine whether spherical silica can achieve similar or~     greater extrinsic dental stain and plaque removal, in comparison to dentifrices containing~     higher concentrations of standard abrasive silica, and how the addition of 5% sodium~     tripolyphosphate (STP) enhances cleaning capability.~   "
22789|NCT03268668|"~     The recent validation of thrombectomy in addition to thrombolysis with intravenous~     administration of alteplase suggests a major revolution in the management of acute strokes.~     This treatment option also opens up a new field of research, making possible the analysis of~     the clot responsible for intracranial occlusion. Indeed, in about 30% of the cases, the~     thrombectomy procedure makes it possible to retrieve either partially or completely the clot.~     Previous studies have analyzed the correlation between the composition of the thrombus and~     the etiology of stroke. Their discordant results do not yet make it possible to distinguish a~     particular profile of thrombus according to etiology. Other studies have shown a correlation~     between the proportion of red blood cells in a thrombus and the likelihood that it is visible~     in MRI or cerebral scanning. More recently, one study has demonstrated a correlation between~     the presence of lymphocytes in the thrombus and an atheromatous etiology.~      The main limitations of these studies are the small number of patients included, the high~     variability of conservation protocols and the absence of plasma data, which does not allow~     for research on the correlation between clot composition and plasma biomarkers.~   "
22790|NCT03268655|"~     Estimate the impact of a 6‐week daily intake of 2000 mg of ginger extract on the composition~     of the gut microbiome using a randomized placebo-controlled double-blinded design, i.e.~     examine the change of microbiome over time within and between the subjects..~   "
22791|NCT03268642|"~     This is a retrospective cohort study to assess the clinical outcome of patients with~     fulminant myocarditis using Life-support Based Comprehensive Treatment Regimen and~     conventional therapy. In the present study, participants receive various treatment as part of~     routine medical care without any assignment of specific interventions to them. The process of~     treatment during hospitalization were recorded in medical chart and was reviewed by~     independent research personnel.~   "
22792|NCT03268629|"~     The primary objective of this proposed three-year (June 01, 2018 to May 31,2020) project is~     to verify the effect of 'Mindfulness Based Joyful Sleep' (MBJS) intervention on young and~     middle-aged individuals with insomnia in China and preliminarily explore inflammatory~     response for the intervention of insomnia applied by it. Previous researches show that~     Mindfulness-Based Interventions may relieve insomnia, it is hypothesized that MBJS will be an~     effective, feasible and affordable insomnia intervention program in China.~   "
22793|NCT03268616|"~     The most significant pathophysiology change of COPD patients is persistent incompletely~     reversible airflow obstruction and increased lung volume. As a result, the work of~     breathing(WB) and neural respiratory drive (NRD)increased. Noninvasive positive pressure~     ventilation (NPPV) can reduce the load of respiratory muscles. Detection of NRD can be the~     index of monitoring for titration of optimal level of ventilator support in the future. As~     electromyography(EMG) is the most reliable measurement in evaluating NRD that can be used for~     human. Currently the standard method for evaluation of NRD with EMG is using esophageal~     multi-paired electrodes catheter(EMGdi) ,it is reliable but invasive .Surface respiratory EMG~     (sEMG）is a noninvasive measurement. Although it subjected to contamination and less~     sensitive, recently, advance in technology with multiple pair of surface electrodes is~     possible to sufficient signals for evaluation of NRD.So the investigator compare the NRD~     measured by EMGdi and sEMG,and consider that the correlation between them is well in~     different levels.~   "
22794|NCT03268603|"~     The purpose of this study is to determine the safety and efficacy of intrathecal treatment~     delivered to the cerebrospinal fluid (CSF) of mesenchymal stem cells in ALS patients every 3~     months for a total of 4 injections over 12 months.~      Mesenchymal stem cells (MSCs) are a type of stem cell that can be grown into a number of~     different kinds of cells. In this study, MSCs will be taken from the subject's body fat and~     grown. CSF is the fluid surrounding the spine.~      The use of mesenchymal stem cells is considered investigational, which means it has not been~     approved by the Food and Drug Administration (FDA) for routine clinical use. However, the FDA~     has allowed the use of mesenchymal stem cells in this research study.~   "
22795|NCT03268590|"~     The investigators will conduct a non-randomized clinical trial to examine the effect of pure~     oxygen breathing on the brain. The study will compare cerebral blood flow, cortical~     electrical activity, and cognitive performance in 32 persons during room air (21% oxygen)~     breathing and pure oxygen (100% oxygen) breathing. Subjects will be used as their own~     controls. The investigators aim to:~        1. Determine whether breathing 100% oxygen changes blood flow through the brain. The~          investigators will learn whether brain blood flow is increased, decreased or stays the~          same.~        2. Determine if changes that might occur in brain blood flow are also accompanied by~          changes in the brain's electrical activity (EEG).~        3. Learn whether changes in the speed at which the brain processes information (cognitive~          function) accompany changes in brain blood flow and electrical activity that may be~          seen.~   "
22796|NCT03268577|"~     This research trial studies how well internet-based and self-report instruments measure food~     intake and physical activity levels and their relationship with disease within American~     Association of Retired Persons (AARP) members. Comparing new internet-based questionnaires~     developed by the National Cancer Institute that report all the foods consumed and activities~     performed in an entire day to standardized physical measurements may help to determine if the~     information collected is accurate.~   "
22797|NCT03268564|"~     Objectives To evaluate the efficacy of a program promoting HIV self-testing (HIVST) with~     online real-time counselling (HIVST-online) among men who have with men (MSM) in Hong Kong.~      Participants Inclusion criteria are: i) Hong Kong Chinese speaking males aged ≥ 18 years old,~     ii) self-report having had anal sex with at least one man in the last six months, iii)~     willing to leave contacts (mobile phone and/or social media account), and iv) having access~     to online face-to-face communication tools like Line, Skype, or Facetime. Those having been~     diagnosed as HIV positive will be excluded.~      Design A total of 350 eligible MSM will be recruited and invited to participate the program,~     including 120 HIVST-online users in a HMRF project (ref#11120791) (re-testers), and 230 new~     prospective HIV testers (new-testers) through outreaching at gay venues (bars and saunas),~     internet and social media, and referrals made by participants.~      A brief baseline telephone survey will be conducted among all participants they are exposed~     to the components of the health promotion program. All participants will be followed up at~     Month 6 by phone/social media for outcome and process evaluation.~      Main outcome measures The primary outcome is whether the participant has taken up our~     HIVST-online service during a 6-month follow-up period. This behavioural outcome will~     recorded objectively by the HIVST administrators. Among those who had not taken up HIVST at~     Month 6, they will be contacted by social media to ask a few questions to assess secondary~     outcomes, which include: 1) whether having taken up any form of HIV testing other than~     HIVST-online and 2) intention to take up HIVST-online or other forms of HIV testing in the~     next six months. Process evaluation of the health promotion components (e.g., online video,~     MI, and project webpage) and the HIVST-online service (e.g., delivery of the HIVST kits,~     appointment making with HIVST administrators, pre- and post-test counseling) will also be~     conducted.~   "
22799|NCT03268538|"~     Introduction: Chronic obstructive airway disease (COPD) is common condition in old age and~     the perception of hypoxia is often impaired in some COPD patients. Therefor it is need to~     monitor oxygen saturation in older people with COPD. A finger wearable device has been~     developed to measure oxygen saturation and heart rate variability. The investigators~     therefore will perform a cross sectional study to evaluate the clinical application of this~     finger wearable device in the detection and management of COPD in older people.~      Subject and method: 100 COPD subjects and 200 community dwelling older people without~     diagnosis of COPD will be recruited. Physical functioning and lung function test will be~     performed. Subjects will wear a finger wearable device to monitor heart rate variability and~     oxygen saturation and wear another wrist wearable device (Actigraph) to monitor physical~     activity and sleep for 6 days at the same time.~      Statistical analysis: Statistical analysis will be made to examine the potential association~     between oxygen saturation and physical activity and sleep, and the association between heart~     rate variability and physical activity and sleep.~   "
22800|NCT03268525|"~     The investigators aim is to study the effect of pre-operative local anesthetic on post~     vaginal hysterectomy pain.~   "
22801|NCT03268512|"~     A split-mouth design study will be performed regarding the use of platelet concentrates on~     ridge preservation: L-PRF vs A-PRF vs control. Patient needing multiple teeth extractions in~     the upper jaw (single-rooted teeth) will be recruited. The use of each platelet concentrate~     or control will be randomized by means of a computer program. The results will be analysed~     clinical and radiographically (CBCT). When the subject will choose for implant~     rehabilitation, a biopsy will be taken in the site of the preserved sockets. The region will~     be localized with a customized stent, fabricated with the position of the extracted teeth.~     VAS scales will be provided to evaluate the post-operative discomfort.~   "
22802|NCT03268499|"~     The aim of the study was to evaluate the safety and efficacy of using the new formulation~     (Lipiodol-cisplatin suspension) for TACE in the treatment of HCC as compared to the~     conventional formulation (Lipiodol-cisplatin emulsion). This is a prospective,~     parallel-group, open-label randomized, phase II study that is conducted in accordance to the~     Declaration of Helsinki and international standards of Good Clinical Practice, and approved~     by the institutional review board. Eligible patients were randomized into either a treatment~     arm of Lipiodol-cisplatin suspension or a control arm of Lipiodol-cisplatin emulsion with a~     1:1 ratio.~   "
22803|NCT03268486|"~     Cardiotocography (CTG) is widely used during labour wards in industrialised countries and~     consists of fetal heart rate and uterine contraction monitoring. The main aim is to identify~     fetuses that are being poorly oxygenated during labour and require medical intervention to~     revert the situation or expedite delivery.~      The need for technical development of CTG is well-recognized, as some of the existing~     techniques are prone to signal loss and contamination from the maternal heart rate, while~     others are invasive and have established contra-indications. They also limit maternal~     mobilisation, contributing to maternal dissatisfaction, and possibly to adverse maternal and~     neonatal outcomes.~      New techniques for CTG acquisition will shortly be made available by a leading technological~     company, providing non-invasive monitoring and allowing full maternal mobilisation, and with~     the potential to change the way labour is conducted in high-resource countries. There is a~     need for a systematic evaluation of their clinical performance and benefit.~   "
22804|NCT03268473|"~     The main objective of this study is to investigate whether the non-surgical periodontal~     treatment of patients with periodontitis and obstructive sleep apnea syndrome (OSAS) affects~     the prognosis of OSAS positively with polysomnographic, serum and saliva parameters.~   "
22805|NCT03268460|"~     Providing summarized information on the clinical and biochemical characteristics and types of~     renal tubular acidosis in children in Assiut University Childern Hospital.~   "
22806|NCT03268447|"~     This project aims to study the benefits of probiotics namely Lactobacillus plantarum P8 for~     brain health properties, primarily alleviation of stress, among adults in Malaysia aged from~     18 to 60 years.~   "
22807|NCT03268434|"~     Aim of the current study is to investigate the acceptance and efficacy of Metacognitive~     Training for Depression (D-MCT) compared to cognitive remediation in outpatients with major~     depressive disorders in a randomized, controlled, assessor-blind, group trial.~   "
22808|NCT03268421|"~     This study evaluates whether Fibromyalgia Integrative Training program for Teens (FIT Teens),~     a combined cognitive behavioral therapy and neuromuscular exercise training program is more~     effective in reducing disability in adolescents with Juvenile Fibromyalgia compared to~     cognitive behavioral therapy (CBT) alone or a graded aerobic exercise (GAE) program alone.~     One third of participants will receive the FIT Teens training; one third will receive CBT~     training; and one third of participants will receive the GAE training.~   "
22809|NCT03268408|"~     Not-randomized controlled study to evaluate a community intervention to promote self-efficacy~     parenting. The treated group will be composed by all newborns resident in S.Ilario d'Enza~     (105 in 2013) where the Baby Newsletter is implemented. Newborns resident in the Health~     District of Montecchio and born in Montecchio Hospital in the same period are the control~     group (278 in 2013). Preterm or hospitalized children are excluded.~      Self-efficacy parenting is evaluated through a questionnaire administered at baseline, after~     5 and 12 months.~   "
22810|NCT03268395|"~     The purpose of this clinical investigation is to compare transcutaneous CO2 (TCCO2) levels~     measured non-invasively using the SenTec Transcutaneous CO2 Monitor to PaCO2 levels measured~     on arterial blood gas (ABG) samples in neonatal patients being treated for respiratory~     distress in the Neonatal Intensive Care Unit (NICU) at Memorial University Medical Center.~   "
22811|NCT03268382|"~     The purpose of this study is to make a preliminary assessment of the efficacy of a combined~     APR-246 and PLD chemotherapy regimen in patients with platinum-resistant recurrent high grade~     serous ovarian cancer (HGSOC) with mutated TP53. In addition, the study aims to assess the~     safety profile of the combined APR-246 and PLD chemotherapy regimen, to evaluate potential~     biomarkers, and to assess the biological activity in tumor and surrogate tissues. The trial~     will enroll at least 25 evaluable patients.~   "
22890|NCT03267329|"~     This study is to evaluate effect and safety on central blood pressure with Duowell compared~     to telmisartan monotherapy in mild dyslipidemia patients with hypertension during 16 weeks.~   "
22812|NCT03268369|"~     Mutations in neuronal nicotinic acetylcholine receptors (nAChRs) have been identified in the~     autosomal dominant nocturnal frontal lobe epilepsy (ADNFLE). Despite the demonstration of a~     gain of function of the mutated receptors, the precise mechanisms leading to this nocturnal~     epilepsy are still unknown. In 2006 the investigators studied the nAChR cerebral distribution~     in a group of patients with ADNFLE carrying a nAChR mutation, by a PET-scan using~     [18F]-F-A-85380, a ligand with a high affinity and specificity for alpha4beta2 nicotinic~     receptors. The study showed a different pattern of brain distribution of the radiotracer in~     the ADNFLE patients when compared to a group of control subjects, with a significant increase~     of nicotinic receptor density in the patients in mesencephalon and cerebellum (Picard et al.,~     Brain 2006). Based on the known biochemical and cellular circuits in the brainstem, these~     results suggest that the nAChR density increase in mesencephalon is involved in the~     pathophysiology of ADNFLE through the role of brainstem ascending cholinergic systems in~     arousal. The follow-up step consists of extending this examination to other forms of~     epilepsy, in order to verify the specificity of the hyperfixation pattern for ADNFLE, and~     search for a potential involvement of nicotinic receptors in other forms of epilepsy. The~     investigators aim to study 5 groups of subjects: control subjects (Group 1, 20 subjects);~     patients with a non lesional partial epilepsy and a predominance of diurnal seizures (Group~     2, 12 subjects); patients with an idiopathic generalized epilepsy (Group 3, 12 subjects);~     patients with nocturnal frontal lobe epilepsy (Group 4, 3 subjects) and epileptic patients~     with vagal nerve stimulation (Group 5, 1 subject). For each patient, a cerebral MRI, [18F]-~     fluorodeoxyglucose (FDG) PET/CT and [18F]-F-A-85380 PET/CT examinations are planned. The~     investigators will perform data analyses on volume of distribution (Vt) parametric images~     which will be based on the ratio of brain tissue to unchanged F-A-85380 plasma at~     equilibrium. Statistical parametric mapping (SPM2) will be used to further study the~     parametric PET images. This study is primarily dedicated to demonstrate that the pattern of~     hyperfixation that was obtained in ADNFLE patients is specific for this disorder and does not~     constitute a common pattern to various forms of epilepsy. The investigators will also search~     for a possible involvement of the nAChRs in other forms of epilepsy.~   "
22813|NCT03268343|"~     This will be an open-label, randomised, 2-period, single-dose crossover study to determine~     the comparative bioavailability of cytisine following single-dose administration in healthy~     male and female subjects under fed and fasted conditions.~      The study will be comprised of a pre-study screen, followed by 2 treatment periods (1 and 2)~     and a post-study follow-up.~   "
22814|NCT03268330|"~     Migration Inhibitory Factor has proliferative and antiapoptotic actions on fibroblasts which~     may be relevant to scleroderma because of the central role of a dysregulated~     fibroproliferative response in disease-affected tissues~   "
22815|NCT03268317|"~     Neuropsychiatric adverse effects of direct acting antiviral drugs, especially Sofosbuvir and~     Daclatasvir combination therapy (with or without ribavirin) in patients with chronic~     hepatitis C , genotype four (the predominant genotype in Egypt).~   "
22816|NCT03268304|"~     Introduction: In the recent past, medical training systems using virtual reality (VR) have~     been introduced to neurorehabilitation to train motor function deficits in patients. The~     usage of VR-based training systems is based on the evidence of neuroplasticity, which is~     responsible for recovery of patients suffering from motor dysfunction. Such systems are~     increasingly used to encourage purposeful limb movements in a VR environment and its efficacy~     has been found comparable with conventional therapeutic intervention. VR training systems,~     e.g. the YouGrabber® (YG), will increasingly also be used at home. Therefore, it is essential~     to integrate valid and reliable assessment tools to monitor the recovery process.~      Objectives: The aim of the clinical study is to evaluate the usability, feasibility and~     validity of the digital version of the ActionResearchArmTest (d-ARAT) using the YG system as~     a platform. Additionally, the feasibility and usability of the implementation of two~     rehabilitation measures that only recently became integral part of neurorehabilitation, e.g.~     Action Observation (AO) and Motor Imagery (MI), into the YG training software will be~     evaluated. Patients & methods: This observational study is designed as a single-arm trial for~     testing the assessment software including pre- to post rehabilitation comparison of a~     training involving AO and MI. Therefore, 75 adult patients with Parkinson's disease, MS,~     Stroke, traumatic brain injury or Guillain-Barré syndrome will be included. 30 out of the 75~     patients will take part in the 4-week training on the enhanced VR-based system with a total~     of 16 training sessions of 45 min each. Primary outcomes will be the score on the System~     Usability Scale (SUS) and the ARAT as well as the d-ARAT scores. Secondary outcomes will be~     hand dexterity (Box-and-Block Test), upper limb activities of daily living (CAHAI) and~     quality of life (EQ-5D-5L).~      Hypothesis: The study was designed to evaluate the d-ARAT and the training software modules~     for the YG system. Currently AO and MI specific tasks are being integrated and the ARAT~     subscales will be implemented on the basis of the redesigned glove equipped with new sensors.~     The results are expected to give recommendations for necessary modifications. They might also~     contribute knowledge concerning the application of AO and MI tasks within VR training.~   "
22817|NCT03268291|"~     The trial was designed in such a way as to show that the proposed program Trust increases~     the proportion of patients who adhere to therapy in the cohort of those with coronary heart~     disease for two years after successful revascularization by using thrombolytic or stenting of~     the coronary arteries against the background of myocardial infarction.~   "
22818|NCT03268278|"~     To see whether the addition of buprenorphone to local anesthesia will lengthen postoperative~     analgesia for endodontic pain~   "
22819|NCT03268252|"~     The standard regimen for elimination of lymphatic filariasis (LF) in PNG is annual~     administration of two drugs at the same time. The two drugs are called DEC~     (Diethylcarbamazine, 6 mg/kg body weight) and ALB (Albendazole 400 mg for all individuals~     regardless of weight), which are given one time per year for five to seven years with the aim~     to interrupt transmission that occurs through local mosquito vectors. These drugs kill the~     larval forms of the parasite in the blood that are necessary for continuing transmission of~     infection by the mosquito vector. The two drugs were previously thought to have little effect~     on adult worms, the stage of the parasite which is responsible for production of the larval~     forms that appear in the blood of infected people. Recent data, however, suggest that DEC and~     ALB can kill or render adult worms unable to produce the larval forms (sterilization).~     Therefore, giving these drugs twice per year for three consecutive years may increase the~     rate of killing or sterilizing of adults worms over regimens that involve administration of~     the same drugs only one time per year. The overall goal of this research is to compare the~     anti-parasite activity of DEC plus ALB given one time per year, the current standard for MDA~     to eliminate LF, to DEC plus ALB given two times per year (at 6-month intervals) in order to~     reduce the total duration and cost of MDA to eliminate LF in PNG. Adults (18 years and older)~     and minors (age 5 to 17 years) will be invited to participate in this study. Study~     participants will be asked to give finger stick blood samples to check LF infection status~     and stool samples to determine how well the drugs eliminate intestinal worm infections.~     Sampling will be done by repeated cross-sectional surveys in the same communities, but not~     necessarily the same persons, one time per year over a 3-year period. As part of the annual~     treatment infection surveillance the study team will also collect demographic data (place of~     residence, family relationship, age, use of bed nets), history of swelling of the arms and~     legs (elephantiasis), scrotal swelling (hydrocele), acute filarial fever accompanied by~     extremity swelling, and history of prior treatment for LF.~   "
22829|NCT03268122|"~     Hospital-acquired infections are common and frequently lead to poor outcomes, including~     death, in affected patients. Two common organisms that cause infections in the hospital are~     methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococcus~     (VRE). One strategy used to prevent these infections is contact isolation of hospitalized~     patients with MRSA and/or VRE. It is unclear whether contact isolation decreases the rate of~     infection with MRSA and/or VRE. The CONTACT-PILOT study is designed to test the hypothesis~     that contact isolation decreases the rate of infection with MRSA and/or VRE in patients in~     the intensive care unit (ICU). The study will enroll all adults in the Medical ICU and will~     run between September 2017 and April 2018. During some months, all patients in the Medical~     ICU patients will be placed in isolation for MRSA or VRE if they have a current infection or~     colonization with either organism, or a recent history thereof. During other months, patients~     will only be placed in isolation for MRSA or VRE if they have an active, highly-transmissible~     infection with either organism, such as a pneumonia or an open, draining wound.~   "
22820|NCT03268239|"~     Gadolinium-enhanced magnetic resonance imaging (MRI) is currently the imaging gold standard~     to detect active inflammatory lesions in multiple sclerosis (MS) patients. The sensitivity of~     enhanced MRI to detect active lesions may vary according to the acquisition strategy used~     (e.g., delay between injection and image acquisition, contrast dose, field strength, and~     frequency of MRI sampling). Selection of the most appropriate T1-weighted sequence after~     contrast injection may also influence sensitivity. Several clinical studies performed at 1.5~     Tesla have shown that conventional 2D spin-echo (SE) sequences perform better than gradient~     recalled-echo (GRE) sequences for depicting active MS lesions after gadolinium injection. As~     relates to MS, 3.0 Tesla systems offer some advantages over lower field strengths, such as~     higher detection rates for T2 and gadolinium-enhancing brain lesions, an important capability~     for diagnosing and monitoring MS patients. Recent studies have shown that at 3 Tesla, 3D GRE~     or 3D fast SE sequences provide higher detection rates for gadolinium-enhancing MS lesions,~     especially smaller ones, than standard 2D SE, and better suppress artefacts related to~     vascular pulsation. However, the comparison of the performance of 3D GRE versus 3D SE~     sequences has not been investigated yet.~      Objectives To compare the sensitivity of enhancing multiple sclerosis (MS) lesions in~     gadolinium-enhanced 3D T1-weighted gradient-echo (GRE) and turbo-spin-echo (TSE) sequences.~   "
22821|NCT03268226|"~     The purpose of this study is to evaluate the effect of inhaled extrafine CHF5993 pMDI on~     airway volumes, and resistance, by Functional Respiratory Imaging (FRI), in COPD patients~   "
22822|NCT03268213|"~     The rationale for fecal microbiota transplantation in patients with refractory Clostridium~     difficile and/or Ulcerative Colitis or indeterminate colitis is its ability to reconstitute~     the normal microbial homeostasis leading to resolution or improvement of symptoms caused by~     the bacteria or underlying inflammatory bowel disease. This is becoming an especially~     important treatment modality as antimicrobial therapy for Clostridium difficile is becoming~     less efficacious due to resistant strains such as the hypervirulent NAP1/ribotype 027 strain.~      Currently long-term follow-up data on patients who have undergone FMT is lacking. There are~     only scattered reports documenting the alteration of the enteric microbial composition and~     function status post transplantation. This study will significantly increase understanding of~     the short and long term safety, efficacy, and tolerability of FMT. It will also enable~     researchers to assess the change in the fecal microbiome after transplantation. Answers to~     these questions may lead to identification of key bacterial taxa to target future therapy.~   "
22823|NCT03268200|"~     The aim of this study was to determine whether segmental re-examination of the each segment~     (right colon, mid-colon, and left colon) could increase the proximal adenoma detection rate~     (ADR) and to evaluate the time-effectiveness of this approach.~   "
22824|NCT03268187|"~     The presented study compares the effectiveness of a biofeedback-based relaxation training~     with the effectiveness of a biofeedback-based self-alert training on the reduction of fatigue~     in multiple sclerosis patients using a between groups design. Furthermore, the relation of~     fatigue in multiple sclerosis patients and autonomic potentials as well as the performance in~     a vigilance task will be examined.~      The relaxation training is based on the principle of progressive muscle relaxation according~     to Jacobsen. The patient is asked to tense all muscles in their face and perceive consciously~     the relaxation afterwards according to verbal cues. In the self-alert training condition, the~     patient will hear verbal cues to increase their attention. In both conditions the external~     cues given will be reduced in four phases until the patient has to cue himself. The patient~     is advised to track the changes in the skin resistance mirrored by biofeedback on a screen.~      In both conditions the training will be split on two days. During the whole examination heart~     rate and skin resistance will be recorded. The allocation to the training happens randomly.~     On the first day the patient will complete questionnaires to survey depression and apathy and~     do a baseline vigilance task. Before and after the vigilance task the current fatigue status~     will be assessed using a visual analogue scale. Afterwards an introduction in the treatment~     method will be given.~      On the second day the introduction into the training will be repeated. Afterwards a short~     time vigilance task will be done and questionnaires to survey fatigue and sleep behaviour and~     quality will be completed. Subsequently the last part of the training (no external cues) will~     be done. The examination will be completed by a long-time vigilance task. Before and after~     the vigilance task the current fatigue status will be assessed using a visual analogue scale.~      It is hypothesised that especially the biofeedback-based self-alert training has a positive~     effect on fatigue and the vigilance performance in multiple sclerosis patients, as it~     increases the ectodermal activity and increases the sympathetic activation. It was shown that~     phasic changes of the skin resistance are correlated with an increase of neuronal activity in~     the brain areas relevant for vigilance (Critchley et al., 2002; Nagai et al., 2004). The~     relaxation training will reduce the sympatho-adrenergic excitation disposition and reduce the~     level of activity. Consequently, we do not expect an alleviation of the perceived fatigue~     according to our underlying model (Hanken et al., 2016). In addition, it is hypothesized~     that, independent from the treatment, autonomic potentials correlate with fatigue.~   "
22825|NCT03268174|"~     The purpose of this study is to observe the performance of a cosmetic product, AO+Mist, on~     the appearance of arm skin in subjects with atopic dermatitis~   "
22826|NCT03268161|"~     Anti-MAG (Myelin Associated Glycoprotein) neuropathy is related to clonal B lymphocyte~     proliferation producing an monoclonal immunoglobulin (IgM) with anti-MAG activity. IgM may be~     a reflection of malignant lymphoproliferative syndrome (Waldenström disease) or, more often,~     monoclonal gammopathy of unknown significance.~      The anti-MAG antibody has a direct toxicity on the myelin sheath of the peripheral nervous~     system responsible for a length-dependent demyelinating polyneuropathy. Clinically, this~     results in a sensitive, ataxic predominant polyneuropathy in the lower limbs, sometimes~     associated with a tremor of attitude and action tremor of the upper limbs.~      Clonal B cells at the origin of IgM production may have acquired mutations affecting MYD88~     (MYD88 L265P mutation) and CXCR4 (Whim-like CXCR4 mutation). The prevalence of the MYD88~     L265P mutation is estimated to be 50% in monoclonal gammopathies of undetermined significance~     and more than 80% in Waldenström disease. CXCR4 Whim-like mutations are found in 40% of~     patients with Waldenström's disease.~      No studies have reported the prevalence of these mutations in patients with anti-MAG~     neuropathies.~   "
22827|NCT03268148|"~     Neonates undergo several painful procedures and these pain experiences can alter clinical~     outcome and behavior. The investigators aim to investigate the analgesic effect of low level~     laser for procedural pain during heel lancing of term neonates.~   "
22828|NCT03268135|"~     This study is aimed to investigate the global transcriptome in order to determine the~     expression profile of messenger RNAs (mRNAs), as well as long noncoding- (lncRNAs) and micro~     noncoding-RNAs (miRNAs) in heart failure (HF) and in aortic stenosis (AS). The aim is to~     clarify their role in cardiac disease pathogenesis, as well as their potential as biomarkers.~     To this purpose, both tissue and blood specimens will be collected and patients will be~     compared to individuals not affected by cardiovascular diseases.~   "
22830|NCT03268109|"~     Despite combined antiretroviral therapy (cART), milder forms of HIV-associated neurocognitive~     disorders (HAND) persist in 20-50% of persons living with HIV (PLHIV). Since more PLH are at~     risk for HAND due to aging, the frequency of HAND in PLHIV ≥ 65 years old is important to~     quantify for planning early intervention to attenuate both functional and occupational~     disabilities due to cognitive impairment.~   "
22831|NCT03268096|"~     Knowledge of the evolution of multiple sclerosis (MS) and its long-term prognostic factors is~     essential to guide the therapeutic management. However, it remains partial and concerns above~     all data collected during the first years of the disease. The evolution towards disability~     can only be assessed after a follow-up of more than 10 years and does not depend solely on~     the initial inflammatory activity of the disease. We propose to realize a standardized~     clinical assessment, an optical coherence tomography (OCT) and a cerebral MRI 15 years after~     the first clinical manifestation of the disease.~      Clinical and paraclinical assessment will consist in the realization of additional MRI~     sequences in order to obtain more precise information on cerebral lesions (unconventional~     parameters). Optical coherence tomography (new generation device) will also be performed on~     both eyes to describe the thickness of the different layers of the retina. A clinical~     evaluation will be performed with the Expanded Disability Status Scale (EDSS).~      This study aims:~        1. to describe the current clinical situation of patients (e.g. percentage of patients with~          moderate or severe disability)~        2. to explore the associations between MRI parameters, those measured with OCT and clinical~          characteristics (disability)~        3. to explore clinical and paraclinical prognostic factors of pejorative evolution~          (disability, severe cerebral atrophy, etc.)~   "
22832|NCT03268083|"~     The objectives of this study are to evaluate the immune response and safety profiles of two~     injections of EV71 vaccine administrated with or without adjuvant Al(OH)3 at 0.5-μg and 1-μg~     dose in children aged 3 to 6 years old and 2 to 35 months old infants/toddlers.~   "
22833|NCT03268070|"~     The goal of the study is to determine the effect of repetitive transcranial magnetic~     stimulation (rTMS) over the premotor cortex on training-related improvements in motor~     performance and associated neural plasticity.~   "
22834|NCT03268057|"~     The purpose of this study is to evaluate the safety and tolerability of IV administration of~     VX15/2503 in combination with a fixed dose of avelumab in patients with advanced non-small~     cell lung cancer. The dose escalation portion of the study will determine the maximum~     tolerated dose (MTD) of VX15/2503 administered in combination with avelumab.~   "
22835|NCT03268044|"~     Surgery is performed at the weekend for risk to life or limb, when mandated by clinical~     guidelines, or depending on resource availability. Weekend healthcare interventions have been~     associated with increased mortality and adverse clinical outcomes in the majority of the~     literature examining the weekend effect, but these findings are not consistent. Results from~     recent observational studies argue against a true weekend effect. Higher rates of adverse~     outcomes associated with hospital activity at weekends do not appear to be due to altered~     medical staffing as commonly hypothesized, but are thought to be in part a result of data~     artefact and confounding by severity or indication. For this study, we hypothesized that~     patients who are admitted to hospital at the weekend and require surgery have an increased~     risk of death compared with patients who are admitted and undergo surgery on weekdays. The~     primary aim was to examine whether patients who underwent surgery and were admitted at the~     weekend had an increased risk of 30 day all-cause mortality compared with patients who were~     admitted and underwent surgery on weekdays; secondary aim was to examine whether the timing~     of surgery (i.e., surgery on the same weekend or surgery on a subsequent weekday) for~     patients admitted at the weekend is associated with increased risk of 30 day all-cause~     mortality.~   "
22836|NCT03268031|"~     Glaucoma is currently the second leading cause of irreversible blindness in the world. Our~     study intends to combine clinical data of glaucoma patients in Zhongshan Ophthalmic Center~     with Artificial Intelligence techniques to create programs that can screen and diagnose~     glaucoma.~   "
22837|NCT03268018|"~     The MODIFY Pilot clinical study in Europe looks to evaluate acute and procedural outcomes~     using a new calcium atherectomy and modification solution in patients with balloon resistant~     calcified lesions in infrainguinal disease. The intent is to both debulk and modify the~     vessel to restore blood flow, improve vessel compliance and drive better outcomes. The MODIFY~     Pilot study will evaluate safety and performance measurements.~   "
22838|NCT03268005|"~     The study compares 2 medicines for type 2 diabetes: fast-acting insulin aspart (a new~     medicine) and NovoRapid®/NovoLog® (a medicine doctors can already prescribe). Fast-acting~     insulin aspart will be tested to see how well it works and if it is safe. Participants will~     get either fast-acting insulin aspart or NovoRapid®/ NovoLog® - which treatment you get is~     decided by chance. Both medicines will be taken together with insulin degludec. Participants~     will need to take 1 injection 4 times every day (all insulins will be provided in pens). The~     study will last for about 8 months (34 weeks).~   "
22839|NCT03267992|"~     The purpose of undertaking CLN0020.p, which is a Substudy of the European Coil registry~     (CLN0014), is to investigate the use of COPD Co-Pilot AIRTM, a COPD disease management~     program manufactured and operated by HGE Health Care Solutions, LLC, in subjects undergoing~     the PneumRx Endobronchial Coil Treatment in a post market setting.~   "
22840|NCT03267979|"~     Different pain assessment methods have been proposed to evaluate analgesic efficacy after~     surgical operation. Pain is a subjective phenomenon. Patient did his pain self assessment.~     But, cooperation of the patient is limited by cultural differences, language barriers or~     residual effect of products used while general anesthesia.~      A lot of study were conducted to demonstrate and to quantify the pain after an operation. The~     aim will be dose analgesic treatment better without cooperation of the patient.~      This sudy concerns patients on the post anesthesia care units one hour after their arrival.~     They will have electrocardiogram and video-pupillometer.~   "
22841|NCT03267966|"~     The study evaluates if a standardized method of pathological evaluation of the specimen~     affects the R1 resection rate after Pancreatico-Duodenectomy (PD) for cancer.~   "
22860|NCT03267719|"~     The aim of the study is to evaluate the effectiveness of laser therapy as a non-surgical~     treatment option in patients with mild and moderate stress incontinence.~   "
22861|NCT03267706|"~     The purpose of this study is to pilot the introduction of a newly developed palliative care~     tool to clinicians in a family health team. The intent of the tool is to improve the quality~     and comprehensiveness of palliative care, which effects caregiver and patient satisfaction~     with care received, as well as clinician satisfaction with their delivery of care. Tool~     effectiveness will be evaluated by measuring satisfaction scores of caregivers, patients and~     clinicians who receive training and access to the tool compared to caregivers, patients and~     clinicians providing usual care (without the tool). Uptake of the tool and user feedback will~     be collected~   "
22842|NCT03267953|"~     Internet-based stress management programs adapted to patients' needs~      Stress is inevitable, and it has many negative consequences on the health of everybody, but~     particularly on the health of patients with a cardiovascular disease (CVD). The good news is~     that patients with CVD can learn to better control their stress through stress management~     programs. Most stress management programs are offered face-to-face by a trained health care~     professional. Research has shown that these programs have a positive impact on the health of~     patients with CVD, including reducing mortality and other risk factors that can make the~     disease worse (e.g., reduces blood pressure). Because of these benefits, the recommendation~     is to offer a stress management program to as many patients with CVD as possible. The problem~     is that their delivery is challenging for most clinics (e.g., too costly to run, health care~     professionals are not available). This means many good stress management programs never make~     it to the patient. Patients also face barriers in accessing traditional stress management~     programs such as stigma or need to travel. Therefore, new approaches are needed to allow~     findings from research to actually have an impact on the public's health.~      One of these approaches is to use the internet to deliver stress management programs. The~     internet has now been used for about 10 years to deliver a range of programs to patients.~     There are limitations to this approach as well. For instance, 40-60% of patients who will use~     an internet-based program will not benefit from it. These patients need more support or~     guidance to get the most out of their internet-based program. This is the problem addressed~     using the proposed innovative trial design. Investigators aim to improve the number of~     patients with CVD who improve after receiving a stress management program by changing the~     type and level of support they receive over time. This type of innovative trial design is~     more and more popular, but has never been used to enhance a stress management programs for~     patients with CVD.~   "
22843|NCT03267940|"~     The study was conducted to assess the safety and tolerability of (1) polyethylene glycol~     (PEG) PEGylated Recombinant Human Hyaluronidase (PEGPH20) in combination with cisplatin (CIS)~     and gemcitabine (GEM) (PEGCISGEM), and (2) PEGPH20 in combination with CIS, GEM, and~     atezolizumab (PEGCISGEMATEZO).~   "
22844|NCT03267927|"~     Assessment of the association of maxillary expansion using a rapid palatal expansion, use of~     a mandibular advancement appliance (MGA™) and of a device allowing sleep in a semi-seated~     position (Yoobreath™) in patients with Obstructive Sleep Apnea (OAS). MGA™ and YooBreath™~     constitute the Yookid system™.~   "
22845|NCT03267914|"~     Approximately 40 people will participate in this study. This study will compare two different~     methods of fluoride application. Both methods are currently used in dental practice and both~     have been shown to be effective. If the participant chooses to participate in this study,~     participant will be asked to either wear a small tray that has been custom made to fit into~     the mouth into which fluoride is placed and worn for 5 minutes at bedtime, or participant~     will be asked to brush fluoride onto the teeth for 2 minutes at bedtime. Participant will be~     randomly assigned to use one of these methods of fluoride application: participant will not~     be allowed to choose which method of application you prefer. Participant will be asked to use~     fluoride every night while enrolled in the study. The fluoride that is used in the study is~     approved by the United States Food and Drug Administration and is commercially available with~     a prescription. After the study is over, participant will need to continue to use fluoride~     every night for life to help reduce the risk for dental cavities in the future.~      During the study, participant will receive a dental examination every 3 months for a total of~     4 study visits over the period of 1 year. This visit will consist of a dental examination to~     identify any new cavities and instructions for fluoride use. Participant will also be asked~     to complete a written log to document daily fluoride use and to give feedback about~     compliance with fluoride use.~   "
22846|NCT03267901|"~     Investigators planed to conduct a randomized, controlled, crossover trial to examine the~     effects of daily walnuts intake among Korean subjects with metabolic syndrome. Primary~     objective of this study was to investigate the effects of daily walnut intake on changes of~     metabolic syndrome indices in Koreans with metabolic syndrome age over 30 years old. This~     study was consisted of four periods: run-in, first intervention, wash-out, and second~     intervention phases. As 16 weeks of first intervention period began after the run-in phase,~     the subjects were randomly assigned into one of two groups: walnut group and control group.~     Participants in walnut group consumed 45 grams of walnuts on a daily basis and participants~     in control group were provided iso-caloric white bread for first 16 weeks. After the first~     intervention and wash-out period (6 weeks), second intervention which is crossover of first~     intervention was started during the next 16 weeks. Anthropometric measurements and~     biochemical analyses were done at the beginning and the end of each intervention (0, 16, 22,~     and 38 weeks of trial). Habitual diet was randomly observed using 3-day diet record once~     during each phase.~      Investigators expected to evaluate 1)effects of walnut ingestion on reverting metabolic~     syndrome to normal status especially by reducing waist circumference and improving serum~     levels of triglyceride and high-density lipoprotein, 2)beneficial effects of daily walnut~     consumption on changes of body composition in the subjects with metabolic syndrome, and~     3)regulatory effects of daily walnut intake on inflammatory markers and diabetic markers.~   "
22847|NCT03267888|"~     This pilot clinical trial studies the side effects of pembrolizumab and radiation therapy in~     treating patients with stage I-III multiple myeloma that has come back after a period of~     improvement or that does not respond to treatment. Monoclonal antibodies, such as~     pembrolizumab, may block cancer growth in different ways by targeting certain cells.~     Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. Giving~     pembrolizumab and radiation therapy may work better in treating patients with stage I-III~     multiple myeloma.~   "
22848|NCT03267875|"~     IgG4 Related Disease is a multi-systemic fibroenophilic disease that includes a basket of~     recently discovered medical conditions.~      The properties that bind them are: lesions similar to tumors in the mixed organs,~     lymphoplasms filtrate enriched with plasma IgG4 positive cells, storiform fibrosis, and~     often, but not always, a high level of IgG4 in the serum.~      This disease has been on the rise for the past two decades and since its recognition in 2001~     there has been impressive progress in understanding its various manifestations, so that today~     almost every body system can be involved.~      One of the conditions associated with this disease is oritis / periortitis and aneurysms~   "
22849|NCT03267862|"~     The study evaluated changes in the depth of the lamina cribrosa at different eye pressures.~   "
22850|NCT03267849|"~     This is a study of the compliance of the lamina cribrosa with change in eye pressure.~   "
22862|NCT03267693|"~     Detection of gastrointestinal complications in mechanically ventilated critically ill~     patients and its relation to oropharyngeal and respiratory infections in relation to~     oropharyngeal and gastric PH.~   "
23013|NCT03265717|"~     Phase 2 study to assess the efficacy of INVAC-1 at a dose of 800 µg for 6 cycles 4 weeks~     apart on Minimal Residual Disease (MRD) eradication rate in the bone marrow, either as a~     single agent in a high risk watch and wait group (group 1 - 42 patients) or in combination~     with ibrutinib (group 2 - 42 patients), in patients with Chronic Lymphocytic Leukemia (CLL).~      Pharmacodynamics and safety will also be assessed.~   "
22851|NCT03267836|"~     Meningioma is the most common central nervous system (CNS) tumor and accounts for~     approximately 30% of all CNS tumors. For meningioma recurring after surgery and radiation~     therapy, there is no effective medical therapy. Repeat surgery or radiation therapy may be~     possible, but they are temporizing measures with limited durable relief. PD-L1 expression in~     meningioma is increased for recurrent tumors or prior radiation therapy, and a recent case~     study reported significant reduction of an intracranial meningioma after 6 months of PD-L1~     blockade. Radiation has been shown to augment immune response when combined with PD-L1~     blockade. Proton radiation therapy has higher relative biological effectiveness (RBE) and may~     further amplify the above immunological signals. Combination of proton radiation therapy~     administered concurrently with PD-L1 inhibitor may maximize immune response for recurrent~     meningioma. However, confirmation of the increased immunogenicity or increased tumor~     infiltrating lymphocytes using the combination of radiation therapy and PD-L1 blockade have~     not been confirmed in patients. The proposed study will be a single institution, single-arm,~     open-label, phase Ib study to combine neoadjuvant avelumab (a PD-L1 inhibitor) with~     hypofractionated proton therapy of 20 CGE (cobalt gray equivalent) over 5 fractions followed~     by planned surgery for recurrent radiation-refractory meningioma. This study is designed to~     provide proof of concept to demonstrate on-target effect of the combination to increase~     immunogenicity by directly examining the resected tumor for immune response and to evaluate~     preliminary clinical efficacy~   "
22852|NCT03267823|"~     The investigator is testing blood samples to compare the results of two different techniques.~     Since blood loss and the need for blood transfusions continue to be major problems after~     heart surgery and other types of surgery, the blood clotting levels are constantly checked~     during heart surgery as part of clinical care.The purpose of this study is to compare the INR~     levels in blood before and after the heart bypass during surgery.~   "
22853|NCT03267810|"~     The purpose of this research study is to: 1) test whether transcutaneous electrical nerve~     stimulation (TENS) after spinal cord injury can reduce the onset of post-injury neuropathic~     pain; and 2) to learn more about this kind of pain and who is at risk for suffering from this~     type of pain after spinal cord injury. Neuropathic pain is a type of pain that occurs in~     about 50% of people with spinal cord injury. This type of pain is usually described as~     burning or tingling, and is present around the level of injury and/or in areas below the~     level of injury. The investigators' goal is to try a non-drug treatment (TENS) that may help~     prevent this pain from occurring. Pain symptoms will be compared between the study~     participants who receive active TENS and the study participants who receive a sham TENS~     treatment.~   "
22854|NCT03267797|"~     Infertility and miscarriage ordinary events in reproductive failure in humans, as are~     affected one couple in every six couples of reproductive age and abortion is including in~     approximately 15-20% of all pregnancies. Over the decades since the beginning of Assisted~     Reproductive Technology (ART) and in vitro fertilization (IVF) pregnancy rate still remains~     below 30% and Recurrent Implantation Failure in one of the most important limiting factor is~     the assisted reproductive techniques. According to studies conducted in recent years one of~     the most important mechanisms of implantation failure is maternal immune system because the~     fetus as an allograft toxic (Semi allograft) to the mother. Studies have demonstrated that~     ratio of Th1 to Th2 cells increase in maternal peripheral blood cells can be directly~     associated with implantation failure. Lymphocytes during implantation, in association with~     endometrium and blastocyst, participate in the production of cytokines, in particular Th1~     pre-inflammatory cytokines. TNFα, IFNγ ،LIF ،IL12 ،IL15 Among these are pre-inflammatory~     cytokines that appear to be necessary in the early stages of implantation. The initial~     inflammatory response should therefore be selectively reduced to preserve pregnancy.~     Inflammatory response impairment at the beginning of pregnancy causes fetal implantation~     failure, while high inflammation leads to acute rejection (spontaneous abortion) or chronic~     (pre-eclampsia) ). Preserving pregnancy requires a specific cytokine pattern, in particular~     Th2 cytokines (IL3, IL4, IL5, IL10, IL13, GMCSF), which causes the anti-inflammatory state of~     pregnancy required. Therefore, maternal immunity seems to be involved in creating and~     sustaining pregnancy through the Th1 / Th2 Thalassic Balance. An imbalance between the two~     systems can be an explanation for the implantation failure in some patients. The effect of~     intra-uterine lymphocyte therapy on the fertility rate of women with RIF in the mouse model~     has been shown to be controlled by the Th1 system. While the Th2 system has a protective~     role, two thirds of patients have had an incomplete endometrial admission. Since the immune~     cells of the uterus are balanced through a broad cytokine pattern, it is important to~     evaluate the implantation success of RIF patients after intrauterine insemination (IUI) of~     their own lymphocytes in the uterus in the pre-implantation phase. Laboratory tests on mice~     show an increase in the number of embryonic implantations with human PMBCs. Considering the~     importance of TH1 and TH2 cells in the success or failure of pregnancy and the relationship~     between the function and balance of these cells with pregnancy problems, such as implantation~     failure (RIF), and the role of factors and inflammatory cytokines in creating proper nesting~     conditions, by introducing the lymphocytes of a participants infected with RIF into the~     uterus in order to induce primary inflammation, the investigators will examine its effect on~     fertility and the success of implantation in women with RIF.~   "
22855|NCT03267784|"~     The aim of this clinical trial is to investigate the efficacy (by monitoring the wound~     surface area reduction of Diabetic Foot Ulcers) and safety (by monitoring adverse events) of~     the medicinal product to be studied after one single application on the wound surface of~     patients with diabetic neuropathic ulcer.~   "
22856|NCT03267771|"~     Recurrent pregnancy loss is classically defined as the occurrence of three or more~     consecutive pregnancy loss. The American Society of Reproductive Medicine has recently~     redefined recurrent pregnancy loss as two or more pregnancy losses. A pregnancy loss is~     defined as a clinically-recognized pregnancy means that the pregnancy has been visualized on~     an ultrasound or that pregnancy tissue was identified after a pregnancy loss.~   "
22857|NCT03267758|"~     Researchers at MCW have discovered a new pathway that links the type of bacteria present in~     the intestines to the severity of heart attacks. This discovery of a relationship between~     intestinal bacteria, bacterial metabolites, and severity of heart attacks means that for the~     first time, the investigators may be able to determine a person's probability of having a~     heart attack via non-conventional risk factors. This may provide opportunities for novel~     diagnostic tests as well as a potential for therapeutic intervention. The link between gut~     microbiota and the severity of heart attacks may also lead to novel therapeutic approaches~     (probiotics, non-absorbable antibiotics) to prevent heart attacks from happening. The studies~     proposed will test the hypothesis that altered intestinal microbiota are mechanistically~     linked to the pathogenesis of cardiovascular disease. The investigator's objective is to~     determine whether inflammatory markers in the blood are decreased and endothelial cell~     function improved by a probiotic in patients with established coronary artery disease.~     Furthermore, the investigators wish to elucidate a mechanism by which the gut microbiota~     regulates serum inflammatory markers.~        1. Specific Aim 1 will determine the impact of a probiotic on circulating leptin and TMAO~          levels, conventional risk factors for cardiovascular disease and diabetes (total~          cholesterol, LDL cholesterol, oxidized LDL, triglycerides, C-reactive protein, serum~          amyloid A, fibrinogen and adiponectin, glucose-dependent- insulinotropic polypeptide~          (GIP), glucagon-like-peptide (GLP-1), glucagon, insulin), and their relationship to the~          intestinal microbiota (15 representative microbial groups) as non conventional risk~          factors. Several blood samples will be collected to measure biomarkers. Participants~          will provide periodic stool samples in order to measure gut bacterial biodiversity.~          Lastly, endothelial cell function (flow mediated dilation) will be measured in order to~          assess blood vessel function.~        2. Specific Aim 2 will determine the impact of a probiotic on metabolites derived from the~          intestinal microbiota as candidates for non-conventional risk factors of cardiovascular~          disease. The relationship between metabolites derived from the intestinal microbiota,~          endothelial cell function and risk factors for cardiovascular disease identified in~          Specific Aim 1 will be correlated.~   "
22858|NCT03267745|"~     This is a safety and tolerability study investigating the effect of an amino acid formulation~     in healthy volunteers during and after limb immobilization.~   "
22859|NCT03267732|"~     To evaluate the pharmacokinetics of single and multiple doses of AM0010 in healthy patients~   "
22863|NCT03267680|"~     This randomized phase II trial studies how well an IRX-2 Regimen works in treating women with~     cervical squamous intraepithelial neoplasia 3 or squamous vulvar intraepithelial neoplasia 3.~     The IRX-2 Regimen consists of a single dose of cyclophosphamide, followed by 21 days of~     indomethacin, zinc-containing multivitamins, and omeprazole. IRX-2, a human cell-derived~     biologic with multiple active cytokine components, may act as an immune booster to stimulate~     the immune system. Giving cyclophosphamide and IRX-2 may work better at treating cervical~     squamous intraepithelial neoplasia or squamous vulvar intraepithelial neoplasia.~   "
22864|NCT03267667|"~     Correlation of severity of obstructive sleep apnea and function of the right ventricle by~     means of 2D echocardiography and cardiac MRI~   "
22865|NCT03267654|"~     This is an open-label, multicenter, randomized, phase II clinical trial, which aims to~     evaluate the effectiveness and safety of gefitinib versus combination of gefitinib and~     doublet chemotherapy or apatinib in advanced non-small cell lung cancer (NSCLC) patients with~     epidermal growth factor receptor (EGFR) activating mutation (exon 19 deletion or exon 21~     L858R point mutation), accompanied with Bim deletion or low activating EGFR mutation~     abundance.~   "
22866|NCT03267641|"~     Hepatocellular carcinoma (HCC) is the 6th most common cancer in the world but the 2nd most~     important cause of cancer death. Because of its highly heterogeneous nature, the current~     approach to identifying druggable targets have not delivered efficacious therapies in HCC and~     is a main reason for the high case fatality. Even when surgical resection is potentially~     curative in early disease, tumor recurrence remains high and long term survival poor because~     of the absence of useful adjuvant therapy.~      To address these unmet needs, the investigators bring together internationally recognized~     scientists from genomics and immunology and established clinician investigators in a~     synergistic team. This TCR capitalizes on recent collaborative advances made by the PIs in~     the consortium. The investigators have shown through multi-region sampling of freshly~     resected HCC and phylogenetic analysis, that significant intra-tumoral heterogeneity exists~     and have identified the specific positions of known clonal drivers. Simultaneously the~     investigators have analyzed the immune landscape of the tumor microenvironment with deep~     immune-phenotyping and found unique inter-patient immune landscapes predictive of clinical~     trajectory.~      This TCR is a prospective study that samples resected HCC from multi-ethnic sites within the~     established Asia-Pacific Hepatocellular Carcinoma (AHCC) Trials Group, which has enrolled~     approximately 1000 patients through 6 multi-center trials in 35 centers in the region.~     Clinical trajectories are tracked and genomic and immunological studies are repeated when~     tumors recu r, to confirm clonally dominant driver mutations and immunological processes that~     are targetable. Concurrently, representative pre-clinical models will be developed from the~     tissues sampled.~      The investigators aim to combine these approaches to overcome the challenges posed by genomic~     heterogeneity and to guide the development of therapeutics and precision medicine in HCC.~   "
22867|NCT03267628|"~     The investigators are comparing post operative analgesia provided for caesarean section~     patients, with the quadratus lumborum type 2 block and intrathecal morphine.~   "
22868|NCT03267615|"~     Patients with advanced chronic liver diseases treated at the Vienna General Hospital of the~     Medical University of Vienna will be offered to participate in this prospective observational~     trial.~      Clinical parameters and laboratory parameters will be recorded for all patients and patients~     will undergo a regular follow-up schedule with clinical visits at the Vienna General~     Hospital.~      This study is linked to a biobank with serum/plasma, ascitic fluid, urine, GI tract biopsies,~     liver biopsies and stool collected from the study participants.~   "
22869|NCT03267602|"~     This is the first study about Neuropsychological function and OSAS in Taiwan. Although the~     correlation between OSAS and neuropsychological abnormalities had been reported, it is worth~     to understand more about the detailed domains that involved in our cohort. After this,~     investigators can dissect the cause of mental retardation in DS and help for further~     treatment strategies.~   "
22870|NCT03267589|"~     The overall objectiv is to obtain preliminary evidence of efficacy of novel agents for the~     management of relapsed ovarian cancer, and in part 2 efficacy of novel agents compared to the~     standard of care (SoC).~   "
22871|NCT03267576|"~     The main purpose of this study is to assess the effects of 4 weeks each of daily treatment~     with canagliflozin 300 milligram (mg) versus sitagliptin 100 mg as treatment adjuncts to~     metformin (at stable dosages) on intrapatient glycemic coefficient of variation (CV),~     expressed as a ratio percentage of standard deviation (SD) to mean glucose levels.~   "
22872|NCT03267563|"~     Postpartum depression (PPD) is common and can have lasting consequences for mother and child.~     ROSE is an intervention to prevent PPD, delivered during pregnancy in outpatient prenatal~     settings. ROSE has been found to significantly reduce cases of PPD in multiple randomized~     trials in community prenatal settings with racially and ethnically diverse low-income~     pregnant women. Requests for ROSE training and recent policy changes supporting payment for~     comprehensive perinatal services to underserved populations suggest a context ripe for~     embedding ROSE in prenatal clinics long-term. Given the need for return on investment studies~     about sustainment efforts, we propose a Sequential Multiple Assignment Randomized (SMART)~     Trial of the effectiveness and cost-effectiveness of a stepwise approach to sustainment of~     ROSE in 90 outpatient clinics providing prenatal care to pregnant women on public assistance~     in 6 U.S. states. In Year 1, all clinics will receive enhanced implementation as usual (EIAU;~     initial training + tools for sustainment). At the first time at which a clinic is determined~     to be at risk for failure to sustain (i.e., at 3, 6, 9, 12, 15 months), that clinic will be~     randomized to receive either: (1) no additional implementation support (i.e., EIAU only), or~     (2) low-intensity coaching and feedback (LICF). If clinics receiving LICF are still found to~     be at risk at subsequent assessments, they will be randomized to either (1) EIAU + LICF only,~     or (2) high-intensity coaching and feedback (HICF). Additional study follow-up interviews~     will occur at 18, 24, and 30 months, but no implementation intervention will occur after 18~     months. Outcomes include: 1. Sustainment of core program elements at each time point and~     total length of time ROSE services were provided and were provided with at least moderate~     fidelity. 2. Health impact (PPD rates over time at each clinic) and reach. 3. ROI (costs,~     cost-offsets, and cost-effectiveness) of each sustainment step. Hypothesized mechanisms~     include sustainment of clinical and organizational capacity to deliver core elements, and~     engagement/ownership. The study will also examine predictors, tailoring variables, and~     implementation processes to determine which kinds of clinics need which level of sustainment~     support and when. To our knowledge, this study will be the first randomized trial evaluating~     the ROI of a stepped approach to sustainment, a critical unanswered question in~     implementation science.~   "
22873|NCT03267550|"~     Remote programming has significant advantages over conventional programming methods on some~     issues. This research will test the safety of SceneRay remote and wireless DBS programming~     system.~   "
22874|NCT03267537|"~     Insomnia is a common medical condition that has a deleterious effect on emotional status,~     health-related quality of life, and has been associated with hospitalizations and all-cause~     mortality. Recently hospitalized patients who are recuperating in their homes would find it~     difficult to return for weekly visits with a clinical psychologist and therefore could~     benefit from the convenience of CBT-I treatment administered in the comfort of their homes~     via the wireless iPAD and video chat software. In patients who are recently discharged from~     the hospital, we wish to assess whether telemedicine-based CBT-I is comparable to~     conventional office-based CBT-I in the efficacy for treating insomnia. Research aiming to~     improve understanding of whether insomnia represents a modifiable risk factor for~     re-hospitalizations in patients who are high utilizers of healthcare services is an important~     area of future research.~   "
22877|NCT03267498|"~     This phase II trial studies how well nivolumab and chemoradiotherapy works in treating~     patients with stage II-IVB nasopharyngeal cancer. Monoclonal antibodies, such as nivolumab,~     may block tumor growth in different ways by targeting certain cells. Chemoradiotherapy is the~     combination of chemotherapy and radiation therapy and may prevent the cancer from spreading~     when combined with nivolumab. Giving nivolumab and chemoradiotherapy may work better in~     treating patients with stage II-IVB nasopharyngeal cancer.~   "
22878|NCT03267485|"~     The aim of the present study is to detect the expression of TET 1 gene in patients with acute~     leukemia and its correlation with clinical and pathological criteria of the patients.~   "
22879|NCT03267472|"~     the pattern of genitourinary fistula in upper egypt~   "
22880|NCT03267459|"~     Retinoblastoma is the most frequent intraocular tumor in children and represents 6% of all~     pediatric cancers before the age of 5 years-old. The outcome is now excellent with 95 to 97%~     of 5-years survival rate. Conservative treatments are being more and more used, and intra~     arterial chemotherapy is one of the adjuvant treatments proposed to the children. The~     treatment is efficient in most cases, but a small proportion of children will have an early~     progression after treatment. MRI is used for the diagnosis of retinoblastoma. We aim to find~     prognostic factors using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) for~     early identification of children response to intra arterial chemotherapy.~   "
22881|NCT03267446|"~     The aim of this study is to assess the value of adding 3D power Doppler (as a diagnostic~     technique) to gray scale technique in the antenatal diagnosis of morbidly adherent placenta~     as well as predict the surgical outcome regarding the type of surgery and the intra operative~     morbidities.~   "
22882|NCT03267433|"~     This randomized phase III trial studies rituximab after stem cell transplant and to see how~     well it works compared with rituximab alone in treating patients with in minimal residual~     disease-negative mantle cell lymphoma in first complete remission. Monoclonal antibodies,~     such as rituximab, may interfere with the ability of cancer cells to grow and spread. Giving~     chemotherapy before a stem cell transplant helps kill any cancer cells that are in the body~     and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to~     grow. After treatment, stem cells are collected from the patient's blood and stored. More~     chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem~     cells are then returned to the patient to replace the blood-forming cells that were destroyed~     by the chemotherapy. Giving rituximab with or without stem cell transplant may work better in~     treating patients with mantle cell lymphoma.~   "
22883|NCT03267420|"~     Hypertension is the single most important risk factor for cardiovascular disease and death,~     yet blood pressure itself is highly influenced by technique and device. Hence, the target~     blood pressure could vary materially based on BP technique and device used. In the present~     study, the investigators will compare 4 different methods of measuring blood pressure in the~     office (casual, resting average of 3 readings with nurse present or absent for resting~     period, and average of 5 readings) as well as a 24 hour ambulatory measurement. The results~     of this study will help and enable practicing family physicians and specialists in Canada to~     target BP for their patients based on algorithm and method of assessment of BP they use in~     their offices.~   "
22884|NCT03267407|"~     This is a multicenter prospective cohort evaluation of the implementation of a cryptococcal~     antigen (CrAg) screening program at selected outpatient HIV clinics (OPCs) and network~     laboratories in Vietnam.~   "
22885|NCT03267394|"~     This study aims to assess the value of TARC in diagnosis of allergic Bronchopulmonary~     Aspergillosis.~   "
22886|NCT03267381|"~     To study if a targeted gene expression profile of RNA, similar to the NETest, can be isolated~     from the peripheral blood of patients with melanoma, to identify active disease, provide an~     assessment of treatment responses, or predict risk of relapse, in conjunction with standard~     clinical assessment and imaging.~   "
22887|NCT03267368|"~     Pulmonary (lung) rehabilitation, which is done under the guidance of lung~     specialists/therapists. It includes breathing exercises, physical exercises, and exercises to~     increase tolerance of activity (stamina). This type of lung rehab has been shown to improve~     symptoms, quality of life, breathing, and walking distance. It has also been shown to~     decrease hospitalization and death rates in chronic obstructive pulmonary disease (COPD) and~     lung cancer patients.~      Comprehensive Care Management Program (CCMP), a program that includes educational sessions~     for tobacco cessation, phone calls, and a home action plan has also demonstrated benefit in~     addition to the pulmonary rehabilitation.~      In this study, the investigators have an opportunity to identify and intervene with COPD~     patients. The vast majority of early stage lung cancer patients are much more scared of their~     cancer than their COPD. Upon identification of COPD and recognition of patient tobacco habits~     for patients planned to undergo SBRT, interventions can potentially be made that will reduce~     COPD hospitalization rates, second primary lung cancer rates, and likely death rates. The~     interventions are broadly available and relatively easily instituted and include the~     following: seeing a doctor to diagnose their other underlying illness or illnesses (both~     respiratory and cardiovascular), smoking cessation if they are smokers, and CCMP's and~     pulmonary rehabilitation which have shown measurable COPD benefits in prior trials.~   "
22888|NCT03267355|"~     The aim is to evaluate the initial experience for the indications and outcomes of EUS in~     Tanta university hospital.~   "
22889|NCT03267342|"~     This project will develop a model for providing low-income people with mental illness with~     supports that enable them to manage their money as well as possible so that they are better~     able to meet their basic needs, to experience less anxiety about finances, and to live~     fulfilling lives in the community with the greatest possible degree of independence. The~     project will work within a citizenship-oriented approach to mental health care, which~     promotes recovery through linking people with mental illness to the rights, responsibilities,~     roles, resources and relationships necessary to achieve full membership in society. The aims~     of the project are to: train clinicians and peer staff so that they are able to integrate~     discussion of financial issues and concerns into their work with clients; provide on-site~     services including financial counseling, peer support groups, help with opening a bank~     account, and a savings club, and; develop a 'financial health' model which can be replicated~     by other providers of mental health services. The investigators hypothesize that the~     intervention will result in improved financial health, reduced financial stress, increased~     community participation, and improved satisfaction with care.~   "
22891|NCT03267316|"~     This study will evaluate the safety, tolerability, and preliminary antitumor activity of~     CAN04 both as a monotherapy and in combination with standard of care treatment in subjects~     with solid cancer tumors.~      Following completion of the first part, the dose escalation cohorts, and determination of~     maximum tolerated dose or recommended phase 2 dose (MTD/RP2D), safety and tolerability will~     be further evaluated in an expanded cohort of subjects with pancreatic or lung cancer, as~     monotherapy or in combination with the standard of care treatment. In addition, early signs~     of efficacy during treatment with CAN04 will be investigated.~   "
22892|NCT03267303|"~     The purpose of this study is to investigate the efficacy and safety after administration of~     TS-091 compared with placebo in patients with narcolepsy.~   "
22893|NCT03267290|"~     Hepatocellular carcinoma (HCC) is unique regarding diagnosis because the clinical diagnosis~     without pathology proof is accepted. The dynamic image, including contrast-enhanced computed~     tomography (CECT) and contrast-enhanced magnetic resonance image (CEMRI) were recognized in~     many guidelines for diagnosing the HCC. In contrast to the CT and MRI, ultrasound (US)~     with/without contrast is suggested by several societies as the sufficient surveillance~     modality. The contrast-enhanced ultrasound (CEUS) has aroused more attentions regarding the~     rapid improvement of contrast medium. In this study, the investigators conducted a~     prospective, single-center, open-label trial to compare the efficacy and safety of CEUS +~     CEMRI in characterizing HCC, in comparison with CECT + CEMRI.~   "
22894|NCT03267277|"~     Background:~      Dermatomyositis (DM) and juvenile dermatomyositis (JDM) cause inflammation in the muscles.~     People with DM and JDM can develop calcium deposits in places they should not, known as~     calcinosis. Calcinosis can be painful and cause disabilities and other problems. Researchers~     want to learn more about calcinosis to find treatments for it.~      Objective:~      To test if sodium thiosulfate (STS) can treat people with DM with calcinosis.~      Eligibility:~      People ages 7 and older who have moderate or severe calcinosis. They must have stable DM and~     calcium deposits in the torso or at least 2 limbs.~      Design:~      Participants will be screened with:~        -  Medical history~        -  Physical exam~        -  Muscle strength and function tests~        -  Blood and urine tests~      Participants will have several visits:~        -  7-day pre-treatment visit about 10 weeks before starting STS~        -  Treatment visits over 10 weeks. They will get STS 3 times a week through IV infusion.~          They may be hospitalized the whole time. If they tolerate the drug, they may be~          discharged at certain times. During these times, they will return for the infusions.~        -  3- to 5-day post-treatment visits 24 weeks and 62 weeks after starting STS.~      Visits may include repeats of screening tests and:~        -  Questionnaires~        -  Scans: They lie in a machine that takes pictures of the body. They may be injected with~          a radioactive agent.~        -  Durometry: A small instrument applies pressure on the skin or exposed calcinosis.~        -  Measurements of blood flow in the arms and fingernail blood vessels~        -  Photographs of the skin~        -  Kidney ultrasound~        -  Tests of kidney function~        -  Calcinosis aspiration: A needle placed into areas of calcinosis removes liquid.~   "
22895|NCT03267264|"~     This is a multi-site, prospective, open-label, randomized, 2 period cross over study~     comparing the subjects' current 32G pen needle (four groups of pen needles) to the BD Nucleus~     pen needle. The study will consist of two 15 day periods ( in which the subject will use each~     pen needle [BD Nucleus pen needle or subject's current pen needle, order randomized] for~     injection. At the end of the last study period, each subject will be asked to evaluate his or~     her perceptions using a 150mm relative VAS scale.~   "
22896|NCT03267251|"~     Vaccination against Human Papillomavirus is recommended for adolescent females by the~     Advisory Committee on Immunization Practices (ACIP), physicians, and many medical~     organizations, yet uptake of HPV vaccines remains very low. CDC data reveal that in 2013 only~     44.3% of 13-17 year old females in New Mexico (and 37.6% nationwide) had completed the 3-dose~     HPV vaccine series. These data reveal the uptake of the HPV vaccines is unacceptably low,~     thereby diminishing its ability to provide population-level protection against the HPV types~     known to cause cervical, vaginal, and vulvar cancers in women, oropharyngeal and anal cancers~     in men and women, and penile cancers in men. The danger of very low vaccination rates is that~     adolescents of all ages will continue to be vulnerable to HPV and the associated cancer~     risks.~      Despite recommendations for HPV, parents continue to have concerns about HPV vaccination.~     Clinicians often lack a clear frame for discussions about HPV vaccination with parents, so~     much so that recent research indicates that pediatricians' discussions with parents about~     vaccinations in general often take the form of bargaining, e.g., since this may be too early~     for the vaccination, can we delay the vaccination schedule? Effective messaging is needed to~     close a knowledge gap among parents around HPV and HPV vaccines, improve communication and~     shared decision-making about HPV vaccination between adolescent girls' parents and~     physicians, and ultimately prompt uptake of HPV vaccines.~      This project will employ a web-based intervention on HPV as a way to improve knowledge,~     communication and shared decision-making about HPV vaccination for 11-13 year old girls and~     their parents. A clinic-based comparative effectiveness randomized trial will be used to~     examine the impact of the website on vaccine-related outcomes and vaccine uptake. New Mexico~     pediatric clinics will be randomly assigned to either the usual care clinic-based~     communication about HPV vaccination or to usual care plus web-based dissemination.~     Assessments of vaccine-related outcomes, including shared decision-making between girls,~     parents and physicians, will be assessed at baseline, 3 months, and 9 months and vaccine~     uptake and dose adherence will be abstracted from clinic vaccine records at 9 months. An~     effective web-based resource should increase parents' knowledge, intentions and motivations~     to vaccinate~   "
22897|NCT03267238|"~     Fecal Microbiota Transplantation will be offered to eligible Crohn's disease patient as~     Investigational New Drug treatment~   "
22898|NCT03267225|"~     Main objective- To study the influence of the polymorphisms of nuclear receptor proteins~     pregnane X receptor (PXR), Liver X receptor alpha (LXRα), and Cytochrome P450 (CYP450) on the~     clindamycin clearance during clindamycin/rifampin combination therapy.~      Secondary objectives To study the influence of these polymorphisms on clindamycin clearance,~     before combination therapy with rifampin (clindamycin monotherapy) To study the influence of~     these polymorphisms on CYP450 activity before combination therapy with rifampin (clindamycin~     monotherapy) To study the influence of these polymorphisms on the increase of CYP450 activity~     after clindamycin/rifampin combination therapy To study the difference between the expected~     and observed clindamycin serum concentrations after dosage adjustment, in patients with~     clindamycin dosage adjustment after combination therapy with rifampin~   "
22923|NCT03266887|"~     Using the population-based data sources in Iceland and the well-characterized AGES-Reykjavik~     cohort, our overarching aims are on exploring whether pre-diagnostic serum levels of~     25-hydroxyvitamin D (25(OH)D) among older individuals living in Iceland were associated with~     survival after cancer diagnosis. We also wanted to assess the risk of being diagnosed with~     cancer in association with 25(OH)D levels. In this population living just south of the arctic~     circle, vitamin D levels largely depend on dietary- and supplemental sources.~   "
22924|NCT03266874|"~     The primary objective of this study is to obtain implant survivorship and clinical outcomes~     data for the commercially available G7 BiSpherical Acetabular Shell.~   "
22899|NCT03267212|"~     The investigators have an existing exercise program (N>70) with a unique population of~     individuals with spinal cord injury (SCI) who have been enrolled in Functional Electrical~     Stimulation - Rowing Training (FES-RT) for at least 6 months. Previous data in the laboratory~     from this exercise platform has recently showed that respiratory restriction in SCI reduces~     inspiratory capacity in direct relation to lesion level, and those with high level injuries~     have the greatest compromise. As a result, the increase in ventilatory requirements with FES~     training results in an imbalance between ventilatory capacity and greater whole body skeletal~     muscle demand after FES rowing training. Hence, external ventilatory support could improve~     the ability to exercise train and hence enhance the adaptations to chronic exercise in high~     level SCI. If our hypothesis is correct, this indicates that maximal aerobic capacity in~     these individuals exceeds maximal voluntary ventilation. It will be important to determine~     however the consistency of this response and at what level of injury it is not observed. In~     parallel of the study # NCT02865343, the investigators will recruit here a population of~     subjects who have completed six months of FES-row exercise training across a range of SCI~     level (C5-T12). Hence, the investigators will be able to determine the consistency of the~     effect and the dependence of the effect on SCI level. Some of them with level >T3 may also~     enroll in training effect study with NIV or sham NIV (NCT02865343))~   "
22900|NCT03267199|"~     -  The relationship between admission MPV, PDW, platelet function test and ST-segment~          resolution in STEMI patients treated with either thrombolytic therapy or primary~          percutaneous coronary intervention~        -  The relationship between admission MPV, PDW, platelet function test and high thrombus~          burden & post-PCI Thrombolysis In Myocardial Infarction (TIMI) flow of infarct related~          artery in STEMI patients treated with primary percutaneous coronary intervention~   "
22901|NCT03267186|"~     This phase II trial studies how well ibrutinib works in preventing acute leukemia in patients~     after reduced-intensity conditioning and stem cell transplant. Ibrutinib may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth.~   "
22902|NCT03267173|"~     Immunotherapy has become the major breakthrough and the most promising treatment, with the~     host of development of tumor biology, molecular biology and immunology. It has become the~     fourth tumor treatment model after traditional tumor therapies (surgery, chemotherapy,~     radiotherapy) . Mesothelin, PSCA, CEA, HER2, MUC1 and EGFRvIII are potential targets and~     spectacular paradigm in the diagnosis and treatment of pancreatic cancer. This study is for~     evaluation of the safety and efficacy of Mesothelin, PSCA, CEA, HER2, MUC1, EGFRvIII targeted~     and other CAR-T cell immunotherapy for pancreatic cancer.~   "
22903|NCT03267160|"~     This research will be the first study for exosomes purified in blood and urine from septic~     patients who had multiple organ failures. Proteomics studies in exosomes from blood or urine~     specimens. Analyze autophage, and apoptosis related biomarkers of exosomes by bioinformatics.~     To find the correlations between exosomes biomarkers and hemodynamic parameters.~   "
22904|NCT03267147|"~     Non-interventional, prospective, observational study to assess the relative risk of anti-CCP~     positive patients to develop (subclinical) signs of inflammation in accordance with early~     Rheumatoid Arthritis (RA) in a population without pre-classified RA but new1 onset of~     non-specific musculoskeletal (MSK) symptoms in general practices in Germany and subsequent 36~     months follow-up by rheumatologists~   "
22905|NCT03267121|"~     This is a non-randomized, phase II, open label study of apatinib mesylate tablets plus~     tegafur gimeracil oteracil potassium capsules induction chemotherapy in locally advanced~     squamous cell carcinoma of head and neck patients who were judged surgically unresectable or~     appropriate for non-surgical definitive therapy.The primary purpose of this study is to~     evaluate the efficacy of apatinib mesylate tablets plus tegafur gimeracil oteracil potassium~     capsules in locally advanced squamous cell carcinoma of head and neck~   "
22906|NCT03267108|"~     A phase 2b, randomized, double-blind, placebo-controlled clinical study to assess the safety~     and efficacy of pulsed, inhaled nitric oxide (iNO) versus placebo in subjects with pulmonary~     fibrosis on long term oxygen therapy (Part 1 and Part 2).~   "
22907|NCT03267095|"~     Music therapy is an established form of creative art therapy. By using music as a specific~     medium of communication, expression and adapting it to the individual resources and abilities~     of the patient, music therapy can be beneficial in activating and supporting mental and~     psycho-physical recover .~   "
22908|NCT03267082|"~     A laparoscopic appendectomy (LA) was first reported by Semm in 1983. Since then, its~     advantages, such as the aesthetic appearance of the wound, less postoperative pain, and~     faster recovery which facilitates early discharge, have been highlighted, and the number of~     procedures performed has been continuously increasing.~   "
22909|NCT03267069|"~     This prospective, analytic observational study will investigate alcohol recidivism in~     patients with alcoholic liver disease. All adult subjects presenting with alcoholic liver~     disease are considered for inclusion. Subjects able to give consent are included.~   "
22910|NCT03267056|"~     The registry is a prospective, multicenter, single arm post-market real-world registry in~     China assessing the clinical use, safety and outcomes of the Orchid 035 DCB Catheter in the~     Superficial Femoral Artery (SFA) and Popliteal Arteries (PA).~   "
22911|NCT03267043|"~     The purpose of this study is to compare neurodevelopment and activity in infants born preterm~     (26 to 33 6/7 weeks gestational age (GA)) receiving Standard Care (SC) or Family Nurture~     Intervention (FNI) in the neonatal intensive care unit (NICU).~      The investigators hypothesize that FNI will improve: i) neonatal electroencephalographic~     activity ii) maternal caregiving and wellbeing (psychological and physiological, and iii)~     infant behavior and neurodevelopment at 18 months corrected age (CA).~      The two-phase effectiveness study aims to:~        -  Phase 1 - Examine the existing Standard Care Approximately 30 infants and their mothers~        -  Phase 2 - Examine effectiveness by implementing FNI unit-wide so that every baby~          receives the intervention Approximately 30 infants and their mothers~   "
22947|NCT03266575|"~     The purpose of this study is to assess the impact of exercise on sarcopenia and frailty. The~     exercise that will be performed in this study will include either pulmonary rehabilitation or~     a formal home based video strengthening program~   "
27077|NCT03212573|"~     A prospective randomized study of patients undergoing Roux-en-Y gastric bypass will be~     randomized in 2 groups: those following an ERAS program and those ones following a standard~     protocol.~      Postoperative pain 24 hours after surgery and hospital stay will be assessed.~   "
22912|NCT03267030|"~     Pegylated-asparaginase (PEG-ASP) is an important part of the treatment of childhood acute~     lymphoblastic leukaemia (ALL). Unfortunately 13% of patients develops allergy and further~     treatment is impossible. Furthermore, 6% of patients have developed antibodies (silent~     inactivation) and have no effect of the PEG-ASP treatment. Truncated asparaginase therapy is~     associated with inferior event-free survival outcomes, in particular relapse in central~     nervous system (CNS).~      Eryaspase is a new formulation of asparaginase encapsulated in erythrocytes. The erythrocyte~     membrane protects asparaginase against fast degradation and elimination processes. The~     encapsulation eliminates the direct somatic contact, and it is hypothesized that this~     provides the potential to prolong the activity of the enzyme and reduce toxicities.~   "
22913|NCT03267017|"~     This prospective study is designed to assess and quantify the correlation between respiratory~     changes in R-R interval and the respiratory changed in invasive systolic blood pressure in~     ventilated patients during changes in posture and peak end expiratory pressure (PEEP) and~     following a fluid bolus~   "
22914|NCT03267004|"~     The purpose of this investigation is to validate a passive image-assisted dietary assessment~     method using images taken by Sony Smarteyeglass and an automatic image analysis software,~     DietCam, to identify food items and estimate portion sizes. Participants will be randomized~     into one of the two orders of meals (Order 1 and 2). In each meal, participants will be given~     a meal that includes a regular-shaped single food (i.e., cookie), an irregular-shape single~     food (i.e., ice cream), a regular-shaped mixed food (i.e., sandwich), and irregular-shaped~     mixed food (i.e., pasta dish).~   "
22915|NCT03266991|"~     An open-label, randomised controlled trial comparing compliance to treatment for latent~     tuberculosis infection in socially marginalised citizens. Participants will be randomized to~     either daily isoniazid for 6 months or weekly rifapentine and isoniazid as directly observed~     therapy for twelve weeks.~   "
22916|NCT03266978|"~     ST-elevation myocardial infarction is a major cause of morbidity and mortality worldwide.~     ST-elevation myocardial infarction damages the regional myocardium that undergoes ischemia~     and necrosis, resulting in impairment of both systolic and diastolic functions of the heart.~     Left ventricular function and myocardial infarct size both serve as the main determinants Of~     patients' outcome after myocardial infarction. Timely management of ST-elevation myocardial~     infarction, using reperfusion therapy, including fibrinolysis and primary percutaneous~     coronary intervention, leads to a better outcome for these patients.~   "
22917|NCT03266965|"~     Specific Aims:~        1. Establish in an open label clinical trial the tolerability and safety of various doses~          of l-histidine and lodosyn that may increase levels of l-histidine and histamine in the~          serum and cerebrospinal fluid (CSF).~        2. Perform pharmacokinetic studies in serum and CSF of study subjects the levels of~          l-histidine and histamine after treatment with various combination of l-histidine and~          lodosyn.~        3. Preliminary information will also be collected on the effects of this intervention on~          alleviation of fatigue.~      The findings from this study go beyond the effects of histamine on fatigue. If central~     histamine can be increased by the strategy outlined above, a number of other vegetative~     hypothalamic functions intricately associated with fatigue including sleep, cognition and~     satiety need to be examined in MS patients in future studies.~   "
22918|NCT03266952|"~     Enrollment of a population-based, prospective cohort of 3298 stroke-free adults was completed~     in 2001 and annual follow-up has continued since then. This collaborative study is the first~     prospective cohort study among whites, blacks and Caribbean Hispanics living in the same~     community. This grant supports continued follow-up and outcome detection and expansion of~     data collection in this cohort. The aims are to evaluate the relationship between vascular~     outcomes (stroke, myocardial infarction (MI), and vascular death) and insulin resistance,~     carotid intima-media thickness, carotid distensibility, and quantitative magnetic resonance~     imaging (MRI) measures of vascular subclinical brain disease and to determine if MRI~     subclinical disease accounts for race/ethnic differences in cognitive impairment. To~     accomplish these aims further data collection using the population-based, prospective cohort~     study is proposed. Stored baseline serum will be used to measure fasting insulin levels to~     evaluate insulin resistance. High-resolution carotid imaging data will be collected at~     subsequent visits to expand the measurements of subclinical carotid disease to 1300 subjects.~     MRIs and a neuropsychological battery emphasizing frontal executive domains will be done on~     1300 subjects and quantitative analyses performed to measure white matter hyperintensities,~     silent infarcts, and silent cerebral microbleeds.~      Starting in 2005, subjects enrolled in the MRI substudy began to have echocardiograms and~     24hour ambulatory blood pressure monitoring. Subjects will be followed by annual telephone~     interviews to ascertain stroke, MI, death, and changes in cognitive state. In-person~     assessment will be done for all subjects who screen positive. Community stroke surveillance~     will be maintained to insure stroke detection among the cohort. Specific diagnostic~     committees classify stroke, MI and vascular death.~   "
22919|NCT03266939|"~     In the United States, 1.5 million people abuse cocaine leading to a host of negative health~     and economic consequences, yet no FDA approved treatment exists. To develop effective~     treatments, the following must be considered: 1) do potential medications ameliorate brain~     disruptions associated with cocaine use? 2) are multiple, targeted treatments necessary? To~     meet these goals, innovative multi-modal neuroimaging will be used to determine whether~     rebalancing the serotonergic (5-HT) system reduces cocaine cue reactivity, impulsivity, and~     normalizes related neurochemistry and brain connectivity.~   "
22920|NCT03266926|"~     In current practice, packing in the vagina overnight after vaginal surgery is typically used~     to prevent post-surgical vaginal bleeding. The vaginal packing is usually coated with either~     estrogen cream or bupivacaine at the investigators' hospital . There are reports in the~     literature that show nasal packing soaked with local anesthetic after nasal sinus surgery~     reduces post-surgical pain. To date, no studies have evaluated local anesthetic soaked~     vaginal packing after vaginal surgery and if this is associated with a reduction in~     post-surgical pain scores.~      The investigators seek to investigate if vaginal packing soaked with a local anesthetic~     reduces post-operative pain while providing the necessary action of minimizing potential~     post-surgical bleeding.~   "
22921|NCT03266913|"~     Neonatal Jaundice occurs in 60% of term infants and 80% of premature infants. Although it is~     transient, it is associated with high rate of readmission of patients in the first week of~     infancy. Neonatal jaundice can cause neurological complications and kernicterus. Considering~     the fact that there have been a lot of studies on probiotic role in management of necrotizing~     enterocolitis (NEC) and few studies on their role in neonatal jaundice, we carried out this~     study to determine the efficacy and safety of probiotics in neonatal hyperbilirubinemia in~     infants hospitalized in children hospital in Bandar Abbas.~   "
22922|NCT03266900|"~     The investigators would like to compare the progression free survival, overall survival,~     quality of life, and safety outcomes of patients receiving versus not receiving a 2nd~     transurethral resection of bladder tumor.~   "
22925|NCT03266861|"~     To our knowledge, the measurement of the transcutaneous oxygen pressure during walking is the~     only continuous method that estimates the importance of ischemia, bilaterally and segment of~     limb by segment of limb. The determination of the lactates concentration, with micro method~     from earlobe sampling, is very widely validated in physiology and exercise physiopathology;~     and it is widely used, by laboratories, for exercise investigation in athletes. We use it in~     routine to evaluate the presence of functional limitation during tcpO2 tests on a treadmill.~      The present study hypothesises a significant relationship between lactatemia variation~     (difference between lactatemia after 3 minutes of recovery from walking and the value at~     rest) and tcpO2 decrease from rest of oxygen pressure (DROP) values for patients with~     peripheral artery disease (PAD).~   "
22926|NCT03266848|"~     This trial will evaluate a non-invasive brain imaging technique QUTE-CE MRI and validate the~     method with first-in-human studies.~   "
22927|NCT03266835|"~     This study is aimed at demonstrating the efficacy and safety of the SoundBite™ Crossing~     System-Peripheral. The study is intended to demonstrate that the SoundBite™ Crossing System~     can facilitate the passage of either devices intended to treat a chronic total occlusion~     (CTO) or additional crossing devices through an infrainguinal CTO into the true lumen.~   "
22928|NCT03266822|"~     Data on the impact of biological therapies, especially of IL6-blocker treatment, on the~     T-cell phenotype in rheumatoid arthritis (RA) are limited, inconclusive, and mainly involve~     short-term follow-up.~      Here, the investigator prospectively measure the percentages of 15 circulating T-cell~     subtypes using flow cytometry. The investigators aim to obtained transversal and longitudinal~     data in 30 anti-TNF responders, 19 secondary anti-TNF-non-responders, 43~     IL6R-antagonist-responders before, 8 weeks and, after, at least, 6 months of biological~     therapy. These are then compared with results obtained in early, untreated RA patients and~     gender-and-age matched healthy controls.~   "
22929|NCT03266809|"~     This study will investigate the influence of systemic adjuvant/neoadjuvant therapy (SAT:~     chemotherapy +/- anti-HER2 antibodies (trastuzumab +/- pertuzumab) on heart function/rhythm~     and cardio-respiratory fitness in recently diagnosed breast cancer patients. In some~     patients, SAT damages the heart (so-called 'cardiotoxicity') and this can have a serious~     impact on the patient's quality of life and overall survival. It has also been suggested that~     anticancer therapies may lead to repolarization abnormalities, QT prolongation and autonomic~     dysfunction, clinically reflected by an increase in HR and a reduction in heart rate~     variability (HRV). There is a lack of information in the literature regarding the extent and~     time-course of changes in cardiac function, cardiac rhythm and cardio-respiratory performance~     ('fitness') in these patients. Moreover, the differential influences of specific treatment~     regimes (e.g. SAT or SAT plus radiotherapy) and different chemotherapy drugs on~     cardio-respiratory performance remain unclear. A better understanding of these issues is the~     primary aim of this study.~   "
22930|NCT03266796|"~     Shared decision making (SDM) is increasingly recommended in health care and reduces the~     unbalanced power between physical therapists and patients. There is an increased focus on~     communication between physical therapists and their patients during the goal setting process~     in current research. This study will focus on SDM in physical therapy goal setting.~      The SDM Process includes a problem definition and different goal options. Good communication~     between physical therapists and patients during the goal setting process with an explicit~     agreeing on both sides regarding treatment goals and options improves patient satisfaction,~     treatment adherence and health outcomes.~      Patients generally prefer to be actively involved in the shared decision making process.~     However, the preferred level of involvement of patients regarding decisions differs.~     Therefore, physical therapist should consider about patients' preferred level of involvement~     in shared decision making. Previous research observed SDM behaviours of physical therapists~     only in private practice settings. Research in other settings like the rehabilitation setting~     are recommended. It is unknown whether there are differences between settings in the SDM~     behaviours of physical therapists during first consultation.~   "
22931|NCT03266783|"~     Apixaban and rivaroxaban have been compared to standard therapy for treatment of acute~     symptomatic venous thromboembolism (VTE) in randomized controlled trials (RCTs), and are both~     approved by Health Canada. No safety or efficacy data is available from direct head-to-head~     comparison of these two anticoagulants. Lawsuits in the United States over bleeding events,~     patient perceptions, and concerns with medication adherence are additional factors~     highlighting the importance of a comparison trial. This multi-center, pragmatic, prospective,~     randomized, open-label, blinded end-point (PROBE) trial aims to compare the safety of~     apixaban and rivaroxaban for the treatment of VTE.~   "
22932|NCT03266770|"~     Traditional ureteral stents are commonly used in renal and ureteral procedures, and their use~     is associated with many morbidities which can affect patients' quality of life. However,~     replacement of the distal portion of the stent with a thin material may reduce bladder~     irritative symptoms and allow the ureterovesical junction to coapt---thereby, reducing~     urinary reflux. The hypothesis is that the RELIEF stent will offer the same function of~     traditional ureteral stents with the added benefits of minimizing urinary reflux and reducing~     irritative bladder symptoms.~   "
22933|NCT03266757|"~     Observational study of the Clinical Practice in patients with Borderline resectable or~     resectable or advanced pancreatic adenocarcinoma.~   "
22934|NCT03266744|"~     This trial is a feasibility study prior to a planned phase III trial. Currently, assessing~     response to treatment of metastatic breast cancer in the bone is limited by the technical~     problems associated with CT scans and bone scans. WB-MRI provides theoretical and practical~     advantages that allow for more detailed analysis of disease response or progression. This may~     allow for earlier identification of progressive disease and earlier change in treatment.~      Participants in the study will have a CT scan, bone scan and WB-MRI at baseline and then~     repeated CT and WB-MRI scans every 12 weeks (until week 96, and then every 24 weeks) until~     there is evidence of progressive disease on either of the imaging modalities. In addition to~     the regular scans on the study, patients will be given the opportunity to participate in a~     study of how reproducible the findings of WB-MRI scans are. At the point of disease~     progression, a repeat bone scan is performed and the involvement of the patient in the trial~     comes to an end.~   "
22935|NCT03266731|"~     Role of anti-platelet in treatment of acute ischemic stroke to determine the safety of~     immediate anti-platelet therapy .that is started as soon as possible within the first 24~     hours of the onset of symptoms.~   "
22936|NCT03266718|"~     This pilot study will develop and test a couple-based physical activity intervention among~     cancer survivors and their partners.~      Aim 1: To determine the feasibility and acceptability of a couple-based physical activity~     intervention for cancer survivors. Feasibility will be quantified using rates of study~     eligibility, overall accrual, attrition, and adherence to the study protocol. Acceptability~     will be assessed via couples' ratings on a standardized measure of treatment effectiveness/~     satisfaction, supplemented open-ended questions~      Aim 2: To provide preliminary data on the effects of a couple-based physical activity~     intervention relative to a wait list control group on survivor outcomes (i.e., level of~     physical activity, quality of life, self-efficacy for achieving and maintaining physical~     activity goals, perceived partner support for physical activity, and quality of the~     survivor-partner relationship). The investigators hypothesize that the intervention will~     produce benefits in each of these domains.~      Aim 3: To provide preliminary data on the effects of a couple-based physical activity~     intervention relative to a wait list control group on partner outcomes (i.e., partner's level~     of physical activity, self-efficacy for helping the survivor achieve and maintain physical~     activity goals, and quality of the survivor-partner relationship). The investigators~     hypothesize that the couple-based intervention will produce benefits in each of these~     domains.~   "
22937|NCT03266705|"~     2 different formulations and doses of tafamidis will be compared. All subjects will receive~     both doses/formulations. Subjects will take tafamidis for 7 days, on the first 2 days they~     will take tafamidis twice, 12 hours apart and then once a day for the next 5 days. Subjects~     will be fasted before taking the drug. Blood samples will be taken to measure the amount of~     tafamidis starting on day 7 and ending on day 8. At least 16 days after the first~     formulation/dose is given, all subjects will repeat the procedure with the other~     formulation/dose.~   "
22938|NCT03266692|"~     This is a phase 1, multi-center, single-arm, open-label study evaluating the safety,~     tolerability, and anti-myeloma activity of ACTR087 (an autologous T cell product) in~     combination with SEA-BCMA (a monoclonal antibody) in subjects with relapsed or refractory~     Multiple Myeloma.~   "
22939|NCT03266679|"~     The aim of this study is to trial an intervention targeting potential deficits in an~     individual's ability to form, and reflect upon, ideas about themselves and others (known as~     metacognitive capacities), specifically in relation to individuals diagnosed with a bipolar~     mood disorder (BMD).~      The proposed research will adopt a mixed qualitative and quantitative design. Participants~     will be recruited through hospital outpatient groups (i.e., Metro South Addiction & Mental~     Health Services Woolloongabba Community Health Centre & Beenleigh Community Health Centre in~     Brisbane, Queensland), and, as necessary, local non government organisations (NGOs),~     psychiatrists, general practitioners, online support networks (SANE Australia, Black Dog~     Institute), community mental health services(such as MINDNET), and/or social media groups~     (Facebook, Twitter) supporting people who meet criteria for a BMD. The research will then use~     clinical interviews and quantitative (survey) methods to: (1) confirm diagnosis of~     participants; and (2) confirm deficits in metacognitive capacities of participants. Following~     this, the research will then involve the implementation of an adapted intervention across a~     course of 12 months, aimed at improving the metacognitive capacities of participants with a~     diagnosis of a BMD.~      The research will provide an enriched understanding of a dimension of people with BMDs that~     has not been previously explored. The research will help with gaining an understanding of the~     metacognitive processes of people with BMDs, and inform more targeted psychological~     interventions.~   "
22940|NCT03266666|"~     Wellness Rx is a 6 class prescription for a healthier lifestyle developed for people in Lake~     County at all levels of health including those struggling with chronic disease. The classes~     are running across the community at all times. It is designed for patients that could benefit~     from healthy diet, exercise, and other healthy lifestyle modifications.~      For those participants attending the classes, they have the option of engaging in this~     evaluation. For those that do, participants will answer questions about their current~     lifestyle, their and their previous history. They will register attendance at each class and~     answer questions about their perception of the class. Then at 45 days and 90 days the~     participants will revisit the same baseline lifestyle questionnaires.~      As participants attend classes, and complete questionnaires, they'll unlock grocery credits~     from online food store ThriveMarket, a basket of fresh produce from the local farmers market~     and local fitness classes to help you towards your goals. The use of these credits will be~     tracked through the 90-day point.~   "
22941|NCT03266653|"~     Related donor Epstein-Barr Virus (EBV) specific cytotoxic T cells (CTLs) manufactured with~     the Miltenyi CliniMACS Prodigy Cytokine Capture System will be administered in children,~     adolescents and young adults with refractory EBV infection post Allogeneic Hematopoietic Stem~     Cell Transplantation (AlloHSCT) or with primary immunodeficiencies (PID).~   "
22942|NCT03266640|"~     CMV cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine~     Capture System will be administered in children, adolescents and young adults (CAYA) with~     refractory cytomegalovirus (CMV) infection post Allogeneic Hematopoietic Stem Cell~     Transplantation (AlloHSCT) or with primary immunodeficiencies (PID).~   "
22943|NCT03266627|"~     Related donor Adenovirus (ADV) specific cytotoxic T cells (CTLs) manufactured with the~     Miltenyi CliniMACS Prodigy Cytokine Capture System will be administered intravenously in in~     children, adolescents and young adults with refractory ADV infection post Allogeneic~     Hematopoietic Stem Cell Transplantation (AlloHSCT) or with primary immunodeficiencies (PID).~   "
22944|NCT03266614|"~     This study is a randomized trial evaluating Recovery 4 US, a social media program aimed at~     the enhancement of community participation and overall recovery of individuals with~     psychiatric disabilities.This innovative e-mental health program integrates Internet and~     mobile technologies and is designed to be a self-sustaining recovery-oriented virtual~     community for individuals living with a disabling mental illness based on the principles of~     Photovoice.~   "
22945|NCT03266601|"~     This is a multicenter, open，randomized controlled trial aiming to evaluate the effectiveness~     of recombinant human interferon α-2b spray compared with ribavirin treatment on pediatric~     patients with herpangina.~   "
22946|NCT03266588|"~     The purpose of this study is to evaluate safety and tolerability of BHV3000 (rimegepant).~   "
39834|NCT03045302|"~     The purpose of the protocol is evaluate the safety, the pharmacodynamics and the~     pharmacokinetic of repeated administration of BIM23B065 in subjects with acromegaly.~   "
22948|NCT03266562|"~     The primary objective of this study is to determine the correlation between the distribution~     of F-18 FES within ER+ breast tumors as seen on Positron Emission Mammography (PEM) images of~     the breast, and the distribution of cells stained ER+ within the tumor by~     immunohistochemistry (IHC) measurements at surgical pathology. The secondary aim is to~     determine if the correlation (or lack of) between F-18 FES uptake and F-18 FDG uptake as~     imaged by PEM, is an accurate representation of the heterogeneity of ER expression in the~     tumor.~   "
22949|NCT03266549|"~     Infantile esotropia is defined as the onset of constant convergent squint in children less~     than 6 months of age. Infantile esotropia is mainly treated surgically using either bilateral~     medial rectus muscle recessions or unilateral medial rectus muscle recession and lateral~     rectus muscle resection with the main goal being to align the eyes so that single binocular~     vision may develop. For infants with very large angles of esotropia (>60 prism diopters~     (PD)), surgery on 2 muscles alone may not be adequate. Approaches to these patients have~     included large bilateral medial rectus muscle (MR) recessions, smaller bilateral medial~     rectus muscle recessions combined with resections of 1 or both lateral rectus muscles (LR) or~     botulinum toxin augmented bimedial recession. Botulinum toxin augmentation of medial rectus~     muscle recession was reported in three previous studies. Lueder et al evaluated the long-term~     outcomes in patients with infantile esotropia. The results were good, with a 74% success~     rate. Based on historical comparisons, this technique appears equally as effective as 3- or~     4-muscle surgery and more effective than large bilateral medial rectus recessions alone.~     Ideally, a prospective randomized study should be performed to more definitively determine~     which of these approaches is best.~   "
22950|NCT03266536|"~     Does the small bowel microbiota in healthy individuals change after consumption of a Western~     diet?~   "
22951|NCT03266523|"~     VERTIM study aims to evaluate the influence of different environments of imaging waiting~     rooms on the anxiety felt by patients before MRI or CT scans. For this, four environments~     (neutral/standard; and nature green, sea, and zen) will be set up in MRI and CT waiting~     rooms.~   "
22952|NCT03266510|"~     The purpose of this study is to assess the efficacy of inspiratory muscle strength training~     for lowering blood pressure and improving physiological function (vascular, motor, and~     cognitive) in middle-aged and older adults with elevated systolic blood pressure.~   "
22953|NCT03266497|"~     This study compares the diet quality between U.S.-born and foreign-born non-Hispanic Blacks~     using pooled NHANES data.~   "
22954|NCT03266484|"~     The study is proposed as a single-site randomized double-blind placebo-controlled trial~     requiring 4 study visits, where two of the visits are combined with their appointment for~     routine clinical care. The study population will consist of patients with quiescent CD and UC~     and IBD-unspecified recruited from the Massachusetts General Hospital Crohn's and Colitis~     center. All eligible subjects will have a confirmed diagnosis of CD, UC, or IBD-unspecified~     according to accepted clinical, endoscopic, radiologic, and histologic criteria. Eligible~     patients will be contacted at the time of their routinely scheduled office visit and~     consented for the study. Self-report and review of medical records will be used to obtain~     detailed information regarding their disease on an intake questionnaire completed by a~     research study coordinator.~      The study is proposed as a 12-week double-blind randomized controlled trial of the probiotic~     supplement compared to placebo. We propose to examine the effect of a specific probiotic~     supplement on the changes in the gut microbiome, serum metabolomic profile, and fatigue~     symptoms in patients with quiescent IBD.~      Within 2 weeks of screening, eligible patients will be invited to visit MGH for a baseline~     visit. The patient will receive either the probiotic supplement or placebo for 4 weeks.~      The first follow up visit will be at week 4 to check for adverse events on study treatment,~     to check accountability of probiotics/placebo, and to complete the set of questionnaires.~     Also, subjects will receive probiotic/placebo samples for the remaining 8 weeks of treatment.~      At week 8, subjects will receive a phone call from a study research coordinator to check in~     with probiotics/placebo intake for treatment compliance and accountability records, and to~     complete the set of questionnaires ascertaining subjective symptoms.~      Last study visit will be at week 12 which is often combined with a regular office~     appointment. Subject will provide serum blood and stool sample, as well as complete the set~     of questionnaires.~   "
22955|NCT03266471|"~     Inflammatory bowel disease (IBD), consisting of two major forms, Crohn's disease (CD) and~     ulcerative colitis (UC), affects more than 1.6 million people in the United States alone.~     Though the precise mechanisms underlying the inflammation and immune responses in IBD are~     still being investigated, various inflammatory mediators, including pro-inflammatory~     cytokines, and genes have been implicated in the disease process. At present, there are no~     reliable mechanisms to predict response to individual IBD medications. The investigators seek~     to evaluate whether inflammatory cytokines change longitudinally during treatment with~     anti-cytokine agents in both treatment primary responders and primary non-responders. In~     addition, the investigators will be evaluating the pharmacogenetics of treatment response to~     these agents.~   "
22956|NCT03266458|"~     all patient presented with ST elevated myocardial infarction and underwent PPCI will be~     calculated with CHA2DS2-VASC score and contrast volume / creatinine clearance as apredictive~     value for Contrast induced nephropathy and the predictive value of these scores will be~     compared with the approved predictive value of MEHRAN score which is also will be calculated~     to every patient .~   "
22957|NCT03266445|"~     The aim of this study is to determine the effect of continuation of buprenorphine/naloxone in~     patients with history of Opioid Use Disorder (OUD) scheduled for upper and lower extremity,~     thoracic and abdominal surgery compared to discontinuation of buprenorphine/naloxone 3 days~     prior to surgery on pain scores, opioid consumption, patient satisfaction, and severity of~     substance use dependence- including record of problematic use of any non-prescribed opioids,~     alcohol and illicit narcotics.~   "
22958|NCT03266432|"~     Evaluation of the use of thromboelastometry for early identification of the underlying~     coagulopathy and to guide individualized transfusion therapy to prevent DIC development~     during ICU stay after cesarean section in women with placenta previa who require a massive~     blood transfusion.~   "
22959|NCT03266419|"~     The aim of this study is to evaluate the influence of depth of neuromuscular blockade during~     laparoscopic gastrectomy on postoperative pain in surgical patients allocated randomly to~     either deep or moderate neuromuscular blockade group with standard-pressure pneumoperitoneum~     of 12 mmHg.~   "
22960|NCT03266406|"~     The aim of this study is to evaluate effect of retrobulbar local anaesthesia after addition~     of hyaluronidase on IOP during cataract surgery~   "
23014|NCT03265704|"~     Maternal high blood pressure remodels the intrauterine environment of the fetus by altering~     hormonal and cellular signaling patterns and, as a result increases the risk of fetal and~     neonatal mortality and morbidity. Newborns of these mothers have an increased risk of~     intrauterine growth restriction, premature birth and hematological abnormalities, such as~     thrombocytopenia, polycythemia, and neutropenia. The purpose of the article is to review~     neonatal thrombocytopenia and neutropenia as a consequence of maternal high blood pressure~     and to establish the optimal management of these cases.~   "
22961|NCT03266393|"~     Adolescents commonly experience barriers to adherence that entail forgetfulness, distraction,~     poor planning, and scheduling problems. A once daily oral regimen may be superior to the~     current regimens that require twice daily dosing. It is currently unclear if Envarsus XR®~     would improve outcomes in adolescent organ transplant recipients. Each patient will receive~     tacrolimus (twice daily immediate release oral formulation) which they are using as part of~     their standard of care immunosuppressive regimen for a portion of the study and Envarsus XR®~     (a once daily extended-release oral tacrolimus formulation) for a portion of the study in a~     cross-over design. Besides the advantage to adherence behaviors, a sustained-release~     tacrolimus preparation may decrease burdensome side effects and increase quality of life.~     Following enrollment, each patient will be maintained in the study for 9 months.~   "
22962|NCT03266380|"~     The primary objective of this study is to assess the incidence of VAP in patients with TBI~     and to identify risk factors for developing VAP in this specific patient population (types of~     co-injuries in patients with multiple trauma or characteristics on admission). The secondary~     objective is to assess the prevalence of pathogens responsible for early- and late-onset VAP~     in patients with TBI. The tertiary objective is to discuss the ability of preventive measures~     to reduce the incidence of VAP~   "
22963|NCT03266367|"~     The aim of this work is to assess the clinical significance of serum levels of neutrophil~     gelatinase-associated lipocalin (NGAL) to predict AKI in patients exposed to PCI.~   "
22964|NCT03266354|"~     the investigator will evaluate the change in endothelial cell count in eyes implanted with~     the iris-claw phakic Artisan lens for treatment of moderate to high myopia using specular~     microscopy~   "
22965|NCT03266341|"~     Early detection of anaerobic bacteria to avoid its serious comlications~   "
22966|NCT03266328|"~     Sample size of 117 patients presented with ST elevated myocardial infarction for PPCI~     starting from september 2017 will be divided to 2 groups, group 1 age up to 40 years old and~     group 2 older than 40 years then previous history and clinical data and angiographic data at~     PPCI and follow up in-hospital and after discharge for 3 months all these data will be~     compared at both groups.~   "
22967|NCT03266315|"~     Probiotics have been started in the NICUs in Calgary since 2016 aiming to decrease the~     incidence of NEC. Adults with abdominal surgery who received post-op probiotics reported a~     significant reduction in surgical site infection, urinary tract infection, and combined~     infection. Currently probiotics used only in none-surgical population of infants The main~     objective of this study is to determine the impact of probiotics administration on length of~     hospital stay in neonates undergoing intestinal surgery. The study will also generate~     important data about safety and efficacy of probiotics in this surgical population.~   "
22968|NCT03266302|"~     Infective endocarditis (IE) is associated with high hospital mortality for various reasons;~     one of them is circulatory failure in patients who undergo cardiac surgery for IE. One~     discussed reason underlying circulatory failure during surgery is the release of~     vasodilatatory mediators and cytokines. This study examines the efficacy and safety of a~     hemoadsorption filter which is approved for the reduction of the concentration of cytokines~     in the bloodstream.~   "
22969|NCT03266289|"~     Primary aim: evaluation of the short term outcome of different techniques used in~     bifurcational coronary arteries intervention regarding major adverse cardiac event (MACE):~     cardiac death, myocardial infarction, target vessel revascularization, or stent thrombosis~     and occurrence of Unstable angina (UA) with ECG changes and echo findings in the same target~     vessel in Assiut university Cath. lab.~      Secondary aim: calculation of the percentage of bifurcational coronary arteries intervention~     in Assiut University Cath.lab~   "
22970|NCT03266276|"~     Rates of depression and anxiety in cancer patients are much higher compared to the general~     population. 40% of head and neck cancer patients will develop significant distress along the~     cancer journey. Less than half of these patients are able to access support, with factors~     such as age, social difficulty, cancer stage and site affecting referral. In 2016, 78,000~     Canadians died of cancer, yet there is limited implementation of routine and integrated~     advanced care planning in cancer care.~      An upcoming deliverable of all cancer centres in Ontario is the integration of Cancer Care~     Ontario's Psychosocial and Palliative Care (PSOPC) pathway into all disease pathways.~     Successful widespread implementation of this pathway at Odette Cancer Centre (OCC) will~     impact >16,000 patients/year. If effective, it will reduce suffering, unnecessary healthcare~     utilization, improve treatment decisions and compliance, enable a better quality of life in~     survivorship and improve quality at end of life. There is a need for better developed,~     standardized response pathways to address PSO and PC needs throughout the patient's journey.~   "
22971|NCT03266263|"~     High-quality cardiopulmonary resuscitation (CPR) and early defibrillation are the most~     important parts of the chain of survival, and they are highly associated with the survival~     rate and life quality of patients with cardiac arrest. It needs the witness to perform~     bystander CPR and use the automated external defibrillator (AED) if CPR and defibrillation~     are expected to be performed earlier. Nevertheless, few patients with cardiac arrest received~     bystander CPR in Taiwan. It might be caused by some reasons. First, traditional training~     programs were inefficient and ineffective in the retention of skills and thus students were~     not confident in their CPR skills after receiving training programs. Second, the current~     training module focused on personal skill training only and lacked teamwork skills training.~     It led to poor performance of the students in actual resuscitation scene, where on-scene~     resuscitators were usually more than one. Third, the current training contents did not~     improve the attitudes and willingness of performing bystander CPR and it caused people who~     had received training program did not resuscitate the patients finally. To improve the~     above-mentioned problem, a three-year research project will be implemented. The aims of the~     project are the following:~        1. to explore the effect of different teaching contents and hand-on practice feedback~          methods on the students' performance of chest compressing, ventilating and using AED in~          the CPR and AED training courses.~        2. to analyze the current situation of teamwork when CPR and AED were performed, to build~          up the collaborating module accordingly and evaluate the effect of the new module on the~          students' performance of chest compressing, ventilating and using AED after the module~          is introduced into the training course.~        3. to understand the factors affecting the motivations and willingness of people to learn~          and practice CPR and AED by utilizing questionnaires, and then to evaluate the effect of~          the creative program, which was modified according to the results of the questionnaires,~          on the motivations and willingness of people to learn and practice CPR and AED.~      The investigators expect to design a more efficient resuscitation skill training course by~     implementing the research project and further to improve the motivations and willingness of~     people to learn and practice CPR and AED in the future.~   "
23015|NCT03265691|"~     Cross ecological quasi-experimental study to assess effectiveness of early intervention in~     the diagnosis and treatment of hyponatremia in the prevention of hospitalized patients´~     falls.~   "
23016|NCT03265678|"~     The aim of this study is to identify genetic patterns in normal ageing skin in order to~     better understand age-related changes.~      Data has suggested that skin ageing has a genetic basis and past studies have identified~     genes that promote skin aging due to sun exposure.~   "
22972|NCT03266250|"~     Study Protocol: Outcome Measurements Primary Outcome The main outcome will be the~     preoperative performance of the dIVCmax/IVCCI ratio to foresee the incidence of hypotension~     after spinal anesthesia in a greater extent to that of the established IVCCI measurements.~      Secondary Outcomes To identify other echocardiographic or clinical measurements that can~     predict an intraoperative spinal-induced haemodynamic instability.~      Sample Size Calculation A pilot study of 20 patients revealed a detected area under the ROC~     curve (AUC) of 0,91 for dIVCmax/IVCCI and for dIVCmax 0,82 with rank correlation between the~     two assays being 0.87 in both positive and negative cases. Based on this result, a sample of~     56 patients will achieve 80% power to detect significant difference (at a level 0.05) between~     dIVCmax/IVCCI and dIVCmax.~      Potential Benefits of the Study The results of this study will allow us to determine which~     clinical or US-measurement can yield better performance so as a preoperative prediction of~     spinal-induced hypotension can be achieved; that way these measurements can permit and guide~     a targeted preoperative fluid challenges prior to the implementation of spinal anesthesia~     Potential Side Effects of the Study Participation in this protocol will not put patients at~     higher risk for complications since we do not perform any intervention (either~     pharmacological or surgical) There will be no occupational risks to researchers or~     assistants. Proposed Timetable According to the exclusion criteria and taking into account~     the number of cases performed in our department per monthly basis, it should take us~     approximately 6 months to recruit 60 patients.~   "
22973|NCT03266237|"~     The aim of this study is to characterize the immune profile of frail and healthy aged~     individuals and investigate their immune responsiveness including the response to influenza~     vaccine over an 18-month period. The project will include a longitudinal study to define~     immune signatures and multi-parameter profiles associated with frailty and may lead to the~     identification of predictive markers of evolution to frailty and Immunosenescence in the~     elderly.~   "
22974|NCT03266224|"~     Torticollis is a clinical sign or symptom that could be the result of a variety of underlying~     disorders. Among the etiologies, Congenital muscular torticollis (CMT) with impairment of the~     sternocleidomastoid (SCM) is the most frequent cause of torticollis in infants. CMT is a~     postural deformity detected at birth or shortly after birth, primarily resulting from~     unilateral shortening and fibrosis of the SCM. Infants with CMT display head tilt to one~     side, which is often combined with rotation of the head to the opposite side. In 2002,~     Chih-Chin Hsu et al. reported that CMT could be classified into four types. The majority of~     Type I and II fibrosis improved after conservative treatment. However, Type III and Type IV~     had more probability in need of surgical correction. However, this categorization lacks of~     objective and quantitative measurement and can be different by subjective judgement of~     different physicians. The purpose of this study is tried to perform digital analysis of~     ultrasonography images to establish an objective, quantitative method and to assess its~     relevance with clinical symptoms and prognosis.~      This study will collect the children younger than one year-old who were impressed or~     suspected to have torticollis in physical medicine and rehabilitation clinic to assess the~     relationship between digitalization results of ultrasound image and clinical manifestations~     and prognosis. Digital image analysis of ultrasound which contains both sides of the SCM in~     transverse and longitudinal view for comparison of lesion side and sound side will be~     performed after the initial enrollment and every six months later. Evaluation of clinical~     manifestations includes measurement of side difference of angles in bilateral neck lateral~     flexion, rotation and habitual head position will performed using an arthrodial protractor by~     a trained member at the beginning of physical therapy and one month later, then every 2-3~     months. All cases will be followed for 1 and a half years. We expect to find some typical~     characteristics of CMT through digital analysis of the SCM. These characteristics include the~     muscle thickness and intensity of echogenicity in the region of interest. The Pearson's~     correlation will be performed to analyze the relevance of quantitative side differences in~     ultrasonography and clinical manifestations including side differences of neck rotation,~     lateral flexion and habitual head position between lesion sides and sound sides.~   "
22975|NCT03266211|"~     In the last ten years, more than one hundred generalized tetanus cases were declared in~     France. Most of them were affecting people older than 70 years with an important mortality~     (around 28%). It is know that the only way to protect ourselves from this disease is the~     vaccination. In France tetanus vaccination is mandatory since 1940.~      Nowaday none study looked specifically for the vaccination of people older than 65 years. The~     hypothesis is: there is a difference in the tetanus vaccination coverage for people older~     than 65 years depending on the demographic and medical practice of their general~     practitioner.~   "
22976|NCT03266198|"~     Normal fetal growth is a critical component for a healthy pregnancy and for ensuring the~     health and well-being of infants throughout childhood and adolescence. One promising area of~     research suggests that changes in fetal soft tissue may be the earliest changes that occur in~     pathologic growth. Three-dimensional volume assessments may be used to detect changes in~     fetal lean mass, fat mass, and organ size that result from pathologic growth earlier than~     conventional 2D measures. This knowledge may lead to interventions that could minimize or~     prevent pregnancy and newborn health problems in the future.~   "
22977|NCT03266185|"~     Chemotherapy-induced alopecia (CIA) is one of the most distressing side effects for patients.~     Scalp cooling can prevent or minimise CIA in approximately half of all patients, depending on~     many factors, e.g. type and dosage of chemotherapy. High rates of success are seen in~     patients treated with taxanes, up to 80-90%. Previous research has shown comparable results~     of scalp cooling in docetaxel-treated patients when shortening the post-infusion cooling time~     (PICT) from the initial standard of 90 minutes to 45- and 20 minutes. A shorter PICT is an~     advantage for both the patient, who can spend less time in the hospital, as well for the~     logistics at oncological departments. Paclitaxel and docetaxel are both classical taxanes,~     that share similar mechanisms of action and have comparable plasma terminal half-life times,~     therefore it seems plausible that the PICT can be shortened for paclitaxel-treated patients~     as well.~   "
22978|NCT03266172|"~     This study will evaluate the pharmacokinetics of GSK2982772 following administration of~     modified release formulations in a capsule relative to an immediate release reference tablet~     formulation and the pharmacokinetics of escalating repeat doses of a selected modified~     release prototype. The study is divided into two parts: Part A will be a non-randomized 6~     periods, sequential, 6-way fixed sequence design in which up to 4 MR minitab formulations of~     capsules will be evaluated. Periods 1, 2, and 3 will evaluate a slow MR release duration~     (nominally 24 hours), a fast MR release duration (nominally 10 hours), and IR tablet~     respectively. Periods 4, 5 and 6 will have flexible dose regimen and it will depend on the~     outcomes of Period 1 to 3. Subjects will be admitted to the clinic the previous day before~     dosing. Each in-patient period will consist of 3 days and 2 nights followed by a minimum~     washout period of 7 days between doses. In Part A 16 healthy subjects will be enrolled such~     that at least 12 evaluable subjects complete the study. Part B will be an open-label, repeat~     dose study in which the selected MR minitab formulation in capsule will be evaluated. Each~     in-patient period will consist of 5 days and 4 nights. There will be a minimum of 7 days'~     washout period between the last morning dose of one period and the first dose of the next~     period. In Part B 10 healthy subjects will be enrolled.~   "
22979|NCT03266159|"~     GSK525762 is a novel inhibitor of bromodomain and extraterminal (BET) proteins. Trametinib is~     a potent inhibitor of the mitogen-activated protein kinase proteins (MEK1 and MEK2).~     GSK525762 and trametinib are critical for growth and survival of tumor cells. This will be~     the first study demonstrating the synergistic effect of BET inhibitor and MEK inhibitor~     administered together against tumor cell growth. This study aims to evaluate the safety,~     tolerability, PK, PD, and preliminary efficacy of combination of GSK525762 and trametinib~     when administered concomitantly to subjects with small cell lung cancer (SCLC) and rat~     sarcoma virus oncogene homolog (Ras) mutated solid tumors. The study will be conducted in two~     parts; part 1 will consists of dose escalation and dose expansion cohorts and part 2 will~     consists of four disease specific cohorts (SCLC, Ras-mutated adenocarcinoma [RMAC] of the~     colon [Ras-mutated colorectal cancer {RMCRC}] and/or rectum, Ras-mutated non small cell lung~     cancer [RMNSCLC], Ras-mutated pancreatic adenocarcinoma [RMPAC]) and an optional basket~     cohort (Ras-pathway activated solid tumors [RAST]). Part 1 will focus on selection of the~     Part 2 dose based on safety/tolerability, PK, PD, and efficacy. Part 2 will investigate the~     overall response rate and clinical response. The total duration of study will be~     approximately three years (nine to twelve months for part 1 and two years for part 2).~     Approximately 138-156 subjects will be enrolled in the study.~   "
22980|NCT03266146|"~     This study is to observe the efficacy and safety of 36 weeks short-term optimization~     treatment of glucocorticosteroid in the patients with chronic recurrent drug-induced liver~     injury (DILI).~   "
22981|NCT03266133|"~     This is a pilot randomized controlled trial involving a sleep education intervention in women~     with gestational diabetes to study whether sleep education during pregnancy leads to~     improvement in glycemic control in women with gestational diabetes and improvement in sleep~     duration.~   "
22982|NCT03266120|"~     The objective of the research is to test the hypothesis that participating in group-based~     gardening or group-based art activities may alter the mental health and cardiac physiological~     status of a wellness population of women ages 26-49. Assessment of the effects of gardening~     or art activities on the experimental population will take two approaches, the first being~     the use of physiological measurements of heart rate and blood pressure. The second approach~     will employ six widely used and well-established self-reported assessment instruments that~     will capture information about the health and well-being of participants. These measurements~     and assessments will provide a psychometrically-based before and after mental health status~     and between treatments health summaries of the participants in the gardening group and those~     engaged in the art group activities.~   "
22983|NCT03266107|"~     Objective of study is to evaluate the procedural success rate, clinical effectiveness, and~     health-economic profile of using the Intracept Intraosseous Nerve Ablation System in adult~     subjects with chronic low back pain in the post-market setting~   "
22984|NCT03266094|"~     The purpose of this study is to assess safety and performance with the use of the BiZact™~     device in tonsillectomy procedures in children and adolescents.~   "
22985|NCT03266081|"~     The objective of this study is to investigate quantitative improvement in excessive tearing~     after administration of Bupivacaine, a local anesthetic, into the affected eyelids.~   "
22986|NCT03266068|"~     Some people develop chronic abdominal pain with diarrhea or constipation after an episode of~     acute bacterial gastroenteritis. These symptoms can be consistent with post-infectious~     irritable bowel syndrome (IBS) and can last long after the acute infection is over. The exact~     reason why certain individuals develop these symptoms whereas others don't is not exactly~     clear.~      The researchers are studying changes in gastrointestinal permeability (movement of contents~     across the lining of the intestine) and transit (movement of food through the~     gastrointestinal tract). The researchers are also studying if there are any genetic risk~     factors that are associated with development of this disorder.~   "
22987|NCT03266055|"~     There is growing evidence that nutritional intervention with dietary polyphenols can~     positively modulate the gut microbiota to improve cardiometabolic health. Whether the~     beneficial effects of blueberries on obesity and the metabolic syndrome can be linked to~     their potential impact on the gut microbiota and intestinal integrity remains speculative at~     this time. Moreover, the mechanisms of action underlying health benefits associated to~     blueberry consumption are still unknown. The investigators are thus proposing to combine the~     study of metagenomics, transcriptomics and metabolomics to test whether a prebiotic activity~     of highbush blueberries can play a role in the prevention of obesity-linked metabolic~     syndrome in a clinical setting.~   "
22988|NCT03266042|"~     Collection of Safety, Efficacy and Resource Utilization Information in Patients Who Have~     Received Melphalan PHP with the Delcath Hepatic Delivery System for the Treatment of~     Unresectable Hepatic Malignancy~   "
22989|NCT03266029|"~     Observational study on CHF patients at four sites in Israel. After signing informed consent~     and undergoing screening assessments, eligible patients will record a sentence and/or~     counting into a smartphone and/or recording machine. The app will upload the vocal data to~     the sponsor's servers for analysis.~   "
22990|NCT03266016|"~     This study is a Phase II controlled clinical trial that will obtain comprehensive, serial~     assessments of respiratory muscle strength and architecture to understand the evolution of~     ventilator-induced respiratory muscle weakness in critically ill children, and test whether a~     novel computer-based approach (Real-time Effort Driven ventilator management (REDvent)) can~     preserve respiratory muscle strength and reduce time on MV. REDvent offers systematic~     recommendations to reduce controlled ventilation during the acute phase of MV, and uses~     real-time measures from esophageal manometry to adjust supported ventilator pressures such~     that patient effort of breathing remains in a normal range during the ventilator weaning~     phase. This phase II clinical trial is expected to enroll 300 children with pulmonary~     parenchymal disease, anticipated to be ventilated > 48 hrs. Patients will be randomized to~     REDvent-acute vs. usual care for the acute phase of MV (interval from intubation to first~     spontaneous breathing trial (SBT)). Patients in either group who fail their first Spontaneous~     Breathing Trial (SBT), will also be randomized to REDvent-weaning vs. usual care for the~     weaning phase of MV (interval from first SBT to passing SBT). The primary clinical outcome is~     length of weaning (time from first SBT until successful passage of an SBT or extubation~     (whichever comes first)). Mechanistic outcomes surround multi-modal serial measures of~     respiratory muscle capacity (PiMax), load (resistance, compliance), effort (esophageal~     manometry), and architecture (ultrasound) throughout the course of MV. Upon completion, this~     study will provide important information on the pathogenesis and timing of respiratory muscle~     weakness during MV in children and whether this weakness can be mitigated by promoting more~     normal patient effort during MV via the use of REDvent. This will form the basis for a~     larger, Phase III multi-center study, powered for key clinical outcomes such as 28-day~     Ventilator Free Days.~   "
23056|NCT03265158|"~     To determine whether peripheral blood flow cytometry can reduce or replace invasive bone~     marrow examinations in patients with slow growing lymphomas.~   "
22991|NCT03266003|"~     This study is a U.S.-based, 1 site (with 4 clinical settings), randomized controlled trial~     (with funding from the Centers for Disease Control and Prevention's (CDC) Antibiotic~     Resistance Solutions Initiative) that will be implemented to evaluate traditional directly~     observed therapy (DOT) and electronic forms of DOT (eDOT) for tuberculosis (TB) treatment.~     The trial will assess whether eDOT that employs electronic communication methods, such as~     video via computer or cellphone, is a non-inferior approach to monitor TB treatment~     adherence, compared to traditional in-person DOT (ipDOT), in which a trained person is in the~     physical presence of patients as anti-TB drugs are ingested. ipDOT is the single best~     intervention proven to be successful when it comes to TB patients' adherence to therapy~     (which reduces risk of acquired drug resistance). However, ipDOT is resource intensive and~     many times challenging to facilitate in-person. If eDOT is found to be non-inferior to ipDOT,~     health departments and other clinicians might be able to provide eDOT to certain populations~     of TB patients in a more flexible and potentially cost-saving manner.~   "
22992|NCT03265990|"~     Comparison between Haemorrhoidectomy by Ligasure and conventional surgery~   "
22993|NCT03265977|"~     This clinical trial will evaluate safety, immunogenicity, and efficacy (prevention of Mtb~     infection as measured by IGRA conversions) of H56:IC31 in remotely BCG vaccinated~     adolescents.~   "
22994|NCT03265964|"~     This is a randomized, double-blind, placebo-controlled study of the investigational drug~     uridine as a treatment for suicidal ideation in veterans.~      The investigators hypothesize that the administration of a naturally occurring dietary~     supplement, uridine, will rapidly reduce suicidal ideation in veterans. The purpose of this~     study is to determine whether 4 weeks of uridine supplementation is an effective treatment~     for suicidal ideation in veterans, when compared to a group taking a placebo.~   "
22995|NCT03265951|"~     Obstructive sleep apnea is commonly reported in Veterans with post-traumatic stress disorder,~     which can potentiate symptoms of anxiety and depression, daytime symptoms and worsen~     nightmares. Continuous positive airway pressure is the most effective therapy but adherence~     to treatment is suboptimal. The overarching theme of the proposal is to compare usual care to~     Ramelteon, in a randomized, clinical trial, investigating the effectiveness of physiological~     versus pharmacological intervention on sleep quality of life, insomnia severity and CPAP~     adherence.~   "
22996|NCT03265938|"~     Patients who undergo general anesthesia for surgical procedures frequently need to have a~     breathing tube placed (tracheal intubation) for the duration of the procedure. Most often~     airway management is routine for an experienced anesthesiologist. Less often, airway~     management can be difficult and can result in patient harm. In order to reduce risk,~     anesthesiologists routinely evaluate patients' airways by obtaining a relevant history and~     doing a physical exam, which can aid in predicting which airways may be difficult to manage.~     The gold standard for management of the anticipated difficult airway is to perform an awake~     flexible bronchoscopic intubation after anesthetizing the airway with local anesthesia. This~     affords added safety because the airway remains patent and the patient breaths spontaneously~     until a tracheal tube is secured, at which point general anesthesia can be induced.~      Recently, authors have advocated for alternative methods of management of the predicted~     difficult airway, most commonly by using a video laryngoscope to perform the awake~     intubation. A video laryngoscope provides an indirect view of the larynx using a camera at~     the tip of a rigid laryngoscope. It takes less training to gain and maintain proficiency~     compared to flexible bronchoscopy.~      Previous studies that have shown successful awake intubation with video laryngoscopy in the~     predicted difficult airway have not included patients with head and neck pathology, including~     malignancies or a history of head and neck surgery or radiation. In this study, the study~     team will perform video laryngoscopy in patients with head and neck pathology who require~     awake bronchoscopic intubation for surgery after placement of the tracheal tube and induction~     of anesthesia. The study team hypothesize that it will be difficult to obtain a good view of~     the larynx with video laryngoscopy in some patients with head and neck pathology. If there is~     a significant incidence of difficult video laryngoscopy in this patient population, it will~     reinforce that anesthesiologists need to continue to learn and maintain skills in~     bronchoscopic intubation.~   "
22997|NCT03265925|"~     This is a prospective study investigating the utility of Brain Network Activation (BNA)~     analysis in patients with epilepsy.~   "
22998|NCT03265912|"~     mTBI is widely recognized as a major public health concern in the United States and~     worldwide. mTBI diagnosis remains a clinical challenge as no single test can diagnose every~     concussion. Recent advances in EEG evoked response potential analysis have led to a novel~     technique for assessing brain network activation (BNA) patterns. This study purpose is to~     study this BNA technology in individuals who have sustained a concussion.~   "
22999|NCT03265899|"~     The purpose of this study is to determine whether oxytocin modulates the processing of~     stress-associated chemosignals and which substrates are involved.~   "
23000|NCT03265886|"~     Despite PH adjustment of local anesthetic solution improves the quality of the block in all~     respects with special advantage of early onset of sensory and motor block, adequate level of~     analgesia, and prolongation of duration of block, the effect of warmed bupivacaine should~     have the same effect which have not been evaluated on supraclavicular plexus block for upper~     limb surgery.~      The warmed bupivacaine used in supraclavicular plexus block may reduce sensory and motor~     block onset and prolong the duration of analgesia when compared to bupivacaine at operating~     room temperature.~   "
23001|NCT03265873|"~     Radiotherapy (RT), surgery and chemotherapy (CT) are treatments for head and neck cancers,~     used alone or in combination. Conformal RT with Intensity Modulation (IMRT) is currently the~     reference technique. IMRT requires a precise definition of the target volumes to be treated~     and the anatomical structures to be protected from irradiation. Most studies of head and neck~     cancers published in the literature demonstrate the variability in the contouring of the~     target volumes between radiotherapists. This may have an impact on dosimetry. To date, no~     studies have evaluated the impact of the ENT surgeon's evaluation in volumes contouring. The~     aim of this study is to compare the volumes determined by the radiotherapists alone and those~     determined jointly by the radiotherapists and the ENT surgeon.~   "
23011|NCT03265743|"~     The main risk factor for the development of cervical lesions is human papillomavirus (HPV)~     infection. Vaccination against human papillomavirus, which is offered to all girls aged 11 to~     14, and catching up to girls aged 15 to 19, is an effective method of preventing cervical~     pathology. Despite this, human papillomavirus vaccination coverage remains low in France.~      Some women with cystic fibrosis might need a transplantation, which is a factor associated~     with increased risk of human papillomavirus carriage and cervical pathology. An over-risk of~     cervical pathology would also be present in non-transplanted women with cystic fibrosis.~     Particular attention should therefore be paid to vaccination in this population.~      The objective is to estimate the frequency of human papillomavirus vaccination in young~     patients with cystic fibrosis, and to evaluate the reasons for non-vaccination.~   "
23065|NCT03265041|"~     To detect and evaluate the predictors of graft patency after coronary artery bypass graft~     surgery as assessed by multi-slice CT coronary angiography validated by coronary angiography~   "
23002|NCT03265860|"~     Ischemic strokes are the first cause of handicap in adult people, the second cause of~     dementia and the third cause of death in France. Brain Magnetic Resonance (MR) initial~     assessment is mandatory to get the right diagnosis, to exclude hemorrhagic lesions and to~     determine the best treatment.~      The conventional diffusion weighted imaging sequence is used to establish the diagnosis and~     to estimate the volume of ischemic lesions. The perfusion weighted imaging sequences are also~     used to assess the diffusion-perfusion mismatch which is supposed to be the ischemic penumbra~     corresponding to territories that could be saved with appropriate treatments.~      IntraVoxel Incoherent Motion (IVIM) is a multi-b diffusion sequence which allows to extract~     four quantitative variables (D, D*, f, ADC) related to the true molecular diffusion and~     correlated to the microvascular perfusion.~      It's a quick sequence with no need of contrast injection and allowing a perfect~     coregistration with the true diffusion. It has been validated in many pathologies but not in~     acute strokes.~      The feasibility of this sequence in acute ischemic strokes has already been assessed with~     interesting results.~      The study aims to assess the correlation between the quantitative values of IVIM at initial~     MR exam and the modified Rankin Scale (mRS) score 3 months after an acute ischemic stroke.~   "
23003|NCT03265847|"~     This study evaluates the impact of administering culturally-specific versions of the Danger~     Assessment (DA) tool followed by the tailored safety planning/referral via use of~     internet/smartphone-based safety decision aid (SDA) on immigrant, refugee and indigenous~     women's empowerment, safety and mental health. Half of survivors will receive tailored safety~     planning/referral based on their level of risk assessed by the DA, while the other half will~     receive non-DA informed usual safety planning/referral.~   "
23004|NCT03265834|"~     Complicated intra-ABdominal Infections (CABIs) are abdominal infections where there is an~     abscess inside the abdomen, or a hole (perforation) in an abdominal organ such that infected~     material e.g. faeces, leaks into the abdominal cavity. A recent review of CABIs after gut~     surgery found that they can occur in several ways. They can occur in different parts of the~     abdomen, can be different sizes, and may or may not be caused by a perforated bowel.~     Management includes, where possible, surgical drainage of an abscess or treatment of the~     damaged bowel. In addition, all patients are given antibiotic therapy. Despite the varied~     ways that CABIs occur, we currently tend to treat all CABIs with antibiotics in a similar~     way. CABIs are associated with significant morbidity and mortality. Despite a significant~     amount of disease there is little clinical evidence with which to base treatment on. One~     research study evaluated a short course of antibiotics (4 days) compared with a longer course~     (up to 10 days) in combination with surgical removal of infection. There was little~     difference in outcomes, but in both groups about 1 out of every 7 patients had a relapse. A~     recent review of patients with CABI in Leeds, not in a research study and where surgical~     removal infection is uncommon and antibiotic durations were short, showed that the risk of~     relapse was even higher (about 1 in every 3 patients). The antibiotic management of CABIs in~     the UK is variable and involves giving between 4 days to 28 days of antibiotics.~      In summary, there is an unacceptably high relapse rate in patients treated for CABI, and~     uncertainty about the best length of antibiotic therapy that should be used to prevent these~     relapses. We therefore propose to investigate if long course antibiotic therapy (28 days) is~     more effective than short course antibiotics (≤10 days) in preventing relapses of CABI.~   "
23005|NCT03265821|"~     The aim of this study was to investigate whether cigarette smoking had any impact on the~     clinical outcomes 1 year after active periodontal treatment. Eligible for the study were 5680~     individuals 20-85 years, referred to the specialised clinic for periodontal treatment at~     Gävle County Hospital between the years of 1980 and 2015. Before examination, all individuals~     filled in a questionnaire regarding their medical health, medication and smoking habits.~      Excluded were edentulous individuals and where clinical data 1-year after active treatment,~     or smoking habits were missing (n=1453). Complete data for analyses was available for 4227~     individuals.~   "
23006|NCT03265808|"~     Eighty (80) subjects with Alcohol Use Disorder and Comorbid Major Depression, fulfilling all~     inclusion/exclusion criteria's will be randomly assigned to receive allogeneic human~     Mesenchymal stem cells or placebo in a 1:1 blinded fashion.~   "
23007|NCT03265795|"~     Surgical ablation of large maxillary cysts usually results in considerable hard and soft~     tissue deficits that ultimately affect the final esthetic and functional outcomes.~     Reconstruction of such defects; whether primarily or secondarily; offers much better~     long-term outcomes. However, primary bony reconstruction becomes potentially complicated in~     many cases of such large cysts encroaching or involving the maxillary sinus where a~     communication with the maxillary sinus lining may be unavoidable.~      Reconstruction of such defects can be accomplished using either vascularized or; more~     commonly; non-vascularized autogenous bone grafts. Different bone substitutes remain to be~     another viable option. The simultaneous use of titanium meshes provides physical~     three-dimensional support for the bone graft contained within as well as the overlying soft~     tissues. However, the drawbacks of titanium meshes in such defects remain to be mainly the~     difficulty in adequately shaping the mesh and the lack of proper isolation of the mesh~     contents from the maxillary sinus cavity.~   "
23008|NCT03265782|"~     Comparison between the safety and efficacy of oral paracetamol and oral ibuprofen in~     treatment of Patent Ductus Arteriosus (PDA) in premature infants~   "
23009|NCT03265769|"~     Pecutaneous coronary intervention (PCI) of chronic total occlusions (CTOs) is most commonly~     performed using bilateral transfemoral access and 8 French guiding catheters. However,~     transfemoral approach (TFA) is associated with higher risk of vascular access complications.5~     It has been reported that using transradial approach (TRA) reduces vascular complications and~     may be associated with a better clinical outcome. Transradial access is also used in complex~     PCI interventions.There is a growing body of evidence regarding the use of this approach also~     in CTO procedures. In available literature, all studies comparing TRA vs. TFA in CTO~     consisted of single center and single operator experience. Besides, none of them is~     randomized. To fill in the gap, we sought to examine the technique and outcomes of~     transradial vs. transfemoral CTO PCI in a contemporary multicenter randomized study.~   "
23010|NCT03265756|"~     Pneumonia is a major cause of illness in young children. The investigators are developing and~     testing a new thermometer like device called Multimometer, to measure the respiration rate~     (RR), temperature, heart rate (HR) and the degree of blood oxygenation (SpO2) of children who~     may suffer from pneumonia. These are called vital signs and their measurements greatly help~     to diagnose pneumonia.~      In the first part of the study, and in order to optimize and better align the size of the~     device with the face, the investigators will measure the average size and dimensions of young~     children's face. In the second part of the study, the investigators will compare the vital~     signs measurements with measurements obtained by other commonly used devices in ill children~     who are suspected to suffer from pneumonia.~   "
39868|NCT03044860|"~     Investigation of the anatomical distribution of enteroendocrine cells by a systematic~     approach along the entire human intestinal tract in healthy individuals and patients with~     type 2 diabetes.~   "
23017|NCT03265665|"~     The ACTION intervention: physicAl aCtiviTy In minOrity womeN with asthma is a 8-month~     community-based walking intervention refined to be applicable for sedentary African American~     (AA) women with asthma. The main outcome of this study is to test the feasibility,~     acceptability and estimate the efficacy of the ACTION intervention in a randomized controlled~     pilot of 80 AA women with asthma within a pragmatic community setting.~   "
23018|NCT03265652|"~     The aim of the current study is to examine the contribution of intense pulsed light (IPL) for~     relieving signs and symptoms of dry eye due to meibomian gland dysfunction. The effect of IPL~     will be examined in a study designed as a randomized controlled trial. In the study arm,~     subjects will undergo 4 treatment sessions, consisting of IPL pulses immediately followed by~     expression of the meibomian glands. In the control arm, subjects will undergo the same~     treatments, except that the IPL pulses will be disabled. For each subject, the duration of~     the study will be 10 weeks, as explained in the detailed description,~   "
23019|NCT03265639|"~     The Prebiotics in Peritoneal Dialysis trial is a non-randomized, open-label, crossover study~     of p-inulin for patients with end-stage renal disease treated with peritoneal dialysis.~   "
23020|NCT03265626|"~     Violence against women is a well understood devastating global pandemic, and human right~     violation. One in three women experienced intimate partner violence worldwide. In Ethiopia,~     the level of domestic violence against women is one of the highest in the world. However,~     Ethiopia is signatory for various conventions and incorporate into the constitution and other~     legal frameworks. Nevertheless, effective implementation of the existing policy documents,~     and engaging different stakeholders is very limited. There is paucity of evidence on piloting~     the feasibility of implementing community based preventive intervention programs. Therefore,~     the main aim of this study is to pilot feasibility and implement existing research evidence~     and policy documents at community level to prevent domestic violence against women in Awi~     zone, northwestern Ethiopia This study will be conducted in three districts of the Awi zone,~     Amhara regional state, Northwestern Ethiopia.~      General Objective:The overall aim of this study is to assess the outcome of community based~     interventions implementation to prevent domestic violence against women, enhance community~     response and determinants among women (15-49 years) in Awi Zone, Northwestern Ethiopia from~     November, 2017 to November, 2018.~      Specific Objectives~        1. To assess the baseline level of domestic violence against women in the study area~        2. To identify associated factors of domestic violence against women~        3. To design intervention implementation strategy to tackle domestic violence against women~        4. To implement culturally appropriate/acceptable interventions to address bottlenecks and~          domestic violence against women~        5. To assess the outcome of community based intervention on domestic violence against women~      Research questions~        -  How can prevent domestic violence against women through community based intervention?~        -  What are the bottlenecks of prevention intervention implementation at community level?~        -  How can implementers engage stakeholders to mobilize community and resource to implement~          existing evidence based interventions to transform gender norm?~      Research Hypothesis~        -  Null hypothesis (Ho): this community based prevention intervention will not have effect~          (difference) on the level of domestic violence against women as compared with control~          (standard program).~        -  Alternative Hypothesis (HA): community based prevention intervention will have a better~          effect to make an improvement on the level of domestic violence against women than~          control (standard services).~   "
23021|NCT03265613|"~     The purpose of this study is to evaluate the efficacy and safety of Adipose-derived~     Mesenchymal Stem Cells (AD-MSCs) with moderate to severe psoriasis. Any adverse events~     related to AD-MSCs infusion will be monitored.The primary outcome is the reduction rate of~     PASI(Psoriasis Area and Severity Index) and treatment response will be computed from PASI~     before and after AD-MSCs infusion.~   "
23022|NCT03265600|"~     Among primary care patients, compare the effectiveness of an 8-week mindfulness-based~     intervention (Mindfulness Training for Primary Care[MTPC]) vs. a low-dose mindfulness~     introduction comparator on self-management of chronic illness and illness-related health~     behavior action plan initiation, as well as on measures related to anxiety, depression, and~     stress.~   "
23023|NCT03265587|"~     Objective: To assess whether the feng shui of critical care bed spaces affects the inner~     harmony of nursing staff Design: Prospective cohort study Setting: Doncaster critical care~     department Participants: Critical care nursing staff Main outcome measures: To assess~     self-reported chi scores and their response to feng shui, cake ingestion and ghost sightings~   "
23024|NCT03265574|"~     PROACT will establish the effectiveness of the angiotensin-converting enzyme inhibitor (ACEI)~     enalapril maleate (enalapril) in preventing cardiotoxicity in patients with breast cancer~     undergoing adjuvant epirubicin-based chemotherapy.~   "
23025|NCT03265561|"~     Background. Bone infections can involve the vertebral column, intervertebral disc space,~     spinal canal and soft tissues, can generate neurological deficit in addition to the~     destruction of the bone that causes functional disability. Vertebral osteomyelitis is the~     most frequent, affecting 2 to 7 patients per 100,000 habitants. Management is bone~     debridement and bone reconstruction.~      Objective. Demonstrate that the use of bone allograft is a functional method to stabilize the~     spine after a bone spinal infection Material and methods. Patients with vertebral bone~     destruction are included in two groups. Bone allograft group will receive bone structural~     allograft; Auto and allograft group will receive bone structural allograft plus autograft.~     The bone reconstruction will be performed in a one-time surgical procedure. Bone~     consolidation, pain, functionality, and spine deformity will be evaluated.~   "
23026|NCT03265548|"~     Our research questions are~        1. Will the use of a video laryngoscope lead to decreased attempts~        2. Does this result in more successful intubations and greater confidence in the supervisor~          and the team that a successful intubation has been performed.~   "
23027|NCT03265535|"~     We propose a single-scan two-injection myocardial perfusion imaging protocol using ammonia.~     Subjects will undergo single-scan two-injection imaging as well as regular stress single-scan~     single-injection protocol and the myocardial blood flow of both techniques will be compared.~   "
23028|NCT03265522|"~     Evidence suggests that a Mediterranean diet can have a beneficial effect on brain health.~     Mild cognitive impairment (MCI) describes problems with brain function such as difficulty~     with day-to-day memory and concentration. It is at this stage that Mediterranean diet could~     prove beneficial in terms of prevention.~      Previous research by Queens University investigated the opinions of patients with MCI and~     their care givers to inform the development of Mediterranean diet education material to~     encourage behaviour change. The study suggested that MCI patients lacked awareness of the~     link between Mediterranean diet and brain function, although were interested to learn more.~     Feedback on the developed educational material was positive although there were suggested~     improvements such as tailoring information to memory loss, a potential staged approach to~     delivery and adaptations to the material content.~      This present study aims to pilot test refined educational material among MCI participants to~     evaluate the feasibility of encouraging dietary behaviour change among this patient group.~   "
23029|NCT03265509|"~     The objective of this study is to determine to effect of additional oral glutamine to Kegel~     exercises on pelvic floor strength and clinical parameters of urinary incontinence in females~     with either urinary incontinence (stress and/or urgency) and pelvic prolapse.~   "
23030|NCT03265496|"~     Condorde main objective is to evaluate the correlation between EGFR mutational status~     determined after tumor biopsy and EGFR mutational status analyzed on ctDNA after liquid~     biopsy. EGFR status will be assessed by real time PCR (rtPCR), digital PCR (dPCR) and Next~     Generation Sequencing (NGS) in patients with chemotherapy naive lung carcinoma.~   "
23031|NCT03265483|"~     One striking observation is that a large portion of the inter-person variation in serum~     25-hydroxyvitamin D (25(OH)D) levels is unexplained. In vitro and in vivo studies indicate~     vitamin D synthesizing and metabolizing enzymes are Mg-dependent. Magnesium (Mg)~     supplementation substantially reversed the resistance to vitamin D treatment in patients with~     magnesium-dependent vitamin-D-resistant rickets. The investigators reported in 2013 from~     observational studies conducted in the general US population that Mg intake significantly~     interacted with vitamin D intake in affecting vitamin D status as well as interacted with~     serum 25(OH)D in risk of cardiovascular disease mortality and, maybe, colorectal cancer~     mortality. The potential interaction between Mg and vitamin D was supported by two subsequent~     studies, including a Finnish cohort study and a mouse study.~      In the parent study (Personalized Prevention of Colorectal Cancer Trial, NCT01105169), the~     investigators proposed to measure blood concentration of total 25(OH)D as a secondary aim~     using Elisa approach. However, following the novel finding of Mg-vitamin D interaction~     published by the investigators in 2013, they submitted a separate grant application to NCI~     which was funded in 2014. In the new study, the investigators proposed to use a LC-MS~     approach, which is more accurate and specific than an Elisa method, to measure 5 vitamin D~     metabolites. This new ancillary study allows the investigators to evaluate whether Mg~     supplementation differentially affects vitamin D synthesis and metabolism dependent on~     baseline serum 25(OH)D levels using existing biospecimens collected in our double-blind~     placebo-controlled randomized chemoprevention trial.~   "
23032|NCT03265470|"~     Acute kidney injury and chronic kidney disease usually associated with radical cystectomy~     operation which is the treatment of choice for invasive urinary bladders tumor.~     Peri-operative acute kidney injury (AKI) is common but poorly recognized and managed which is~     associated with increase surgical morbidity and mortality and hospital cost .Prospective~     human studies establishing a renal protective effect of dexmedetomidine are still~     questionable.~   "
23033|NCT03265457|"~     Pseudoexfoliation Syndrome Is a common disorder in Egypt. IT is one of the common causes of~     coexisting cataract and glaucoma. It may be associated with a less than normal endothelial~     count.~   "
23034|NCT03265444|"~     The purpose of conducting phase 1 trial is to evaluate the safety and tolerability of~     autologous bone marrow-derived mesenchymal stem cells(CS10BR05) in subjects with Multiple~     System Atrophy.~      Evaluation of DLT by carotid artery(intra-arterial) injection according to dose-escalating in~     Multiple System Atrophy.~   "
23035|NCT03265431|"~     This study is performed to assess if PET-MR imaging can improve treatment of patients with~     irregular heart rate and heart failure. Heart failure occurs when the heart muscle is too~     weak to do his work correctly. Irregular heart rate can be related to numerous diseases. One~     category of irregular heart rate is called ventricular arrhythmia. It is often seen in~     patients who have had a heart attack. This type of arrhythmia can be dangerous and can cause~     sudden death. To prevent these arrhythmias, doctors can perform procedures that burn the~     source of arrhythmia in the heart muscle. This is called ablation. Unfortunately, ablation~     does not fix the problem in 100% of patients and some will still have the arrhythmia~     requiring repeated procedure. The purpose of this study is to find new ways of guiding the~     doctors performing ablation, hoping to improve the success rate of the procedure.~   "
23036|NCT03265418|"~     To test the feasibility and accuracy of BioXmark fiducial markers for image guided~     radiotherapy (IGRT) based rectal tumor boosting in 20 patients referred for long course~     chemo-radiotherapy of the locally advanced rectal cancer.~   "
23037|NCT03265405|"~     For pulmonary sarcoidosis, the initial dose recommended by the joint statement of the~     American Thoracic Society (ATS), European Respiratory Society (ERS), and The World~     Association of Sarcoidosis and Other Granulomatous Disorders (WASOG) is 20-40 mg per day.5~     The exact dose and duration of treatment for sarcoidosis are unknown.4 We hypothesize that a~     higher dose of 40 mg per day as compared to a 20 mg/day dose of prednisone will be more~     effective in preventing post-treatment relapse by effective initial suppression of the~     granulomatous inflammation and reduction of the disease load. In this study, we compare the~     efficacy and safety of medium dose (40 mg/day prednisone) and low dose (20 mg/day prednisone)~     glucocorticoids in the treatment of acute sarcoidosis.~   "
23038|NCT03265392|"~     The results of our in vitro studies strengthen the hypothesis that the contribution of~     salivary alpha-amylase to starch digestion has been underrated and that this enzyme can play~     an important role in this process. As a result, its inhibition could constitute an~     opportunity to reduce the glycemic response elicited by starch-rich foods. The main goal of~     this study is to verify whether inhibition of salivary alpha-amylase, upon the consumption of~     starchy foods, can have an impact on the postprandial glycemic response, and/or satiety.~   "
23039|NCT03265379|"~     Although chest wall recurrence of breast cancer is uncommon, it represents a difficult~     clinical scenario. The role of full thickness chest wall resection (FTCWR) for breast cancer~     recurrence in the chest wall is controversial and is complicated by the fact that no~     prospective evidence exists evaluating the utility of FTCWR in prolonging survival or~     improving health related quality of life (HRQOL) and thus, there is a lack of evidence to~     guide treatment decisions. Gathering HRQOL, local-regional recurrence (LRR) and survival data~     in a prospective fashion is thus critical in this population. Therefore, we designed a~     prospective trial to evaluate the outcomes for FTCWR in terms of LRC and HRQOL, and~     short-term morbidity and mortality, with secondary focus on potential long-term overall~     survival benefit.~   "
23040|NCT03265366|"~     The aim of the study is to compare the concordance between chest computerized tomography-scan~     (CTscan) and Magnetic resonance Imaging (MRI) for the description of the abnormalities seen~     in Allergic BronchoPulmonary Aspergillosis (ABPA).~   "
23041|NCT03265353|"~     The purpose of this study is to determine if dietary potassium can attenuate the deleterious~     effects of high sodium on blood vessel function in healthy, salt-resistant participants.~   "
29992|NCT03174457|"~     The aim of the study is to prospectively evaluate the safety and efficacy of micafungin when~     prescribed for prophylaxis or treatment of fungal infections in different real-world clinical~     conditions and centers, in pediatric patients in Asia/Oceania.~   "
23042|NCT03265340|"~     Aim: To test if there is a relation between deep Transcranial Magnetic Stimulation (dTMS)~     dose and clinical effect on Major Depressive Disorder (MDD) Method: 30 patients with moderate~     to severe MDD without concurrent medication will be randomised to three different treatment~     protocols of dTMS. Symptom severity of MDD will be quantified before, during and after dTMS.~   "
23043|NCT03265327|"~     This study will investigate the effectiveness of two oral supplements on the ocular signs and~     symptoms in symptomatic dry eye patients. Eligible participants will be given one of two oral~     supplements to take once a day for up to three months.~   "
23044|NCT03265314|"~     Alternatives For Girls (AFG) is offering LeadHer as a gender-specific teen pregnancy~     prevention curriculum to girls between the ages of 14-19 years old who live in Wayne County,~     MI. The curriculum seeks to demonstrate that girls who participate in LeadHer will show~     increased rates of avoidance of unprotected sex, will show increased use of birth control and~     reduced rates of pregnancy. LeadHer will run over a 6-session period covering topics designed~     to prevent teen pregnancy and develop girls into leaders. The sessions will be co-led by~     youth (Peer Educators).~   "
23045|NCT03265301|"~     With the ongoing developments in the field of hysteroscopy during the past 15 years,~     hysteroscopic surgery is becoming safer and less invasive for the patient. Improved~     technology has enabled surgeons to perform many operative procedures in an ambulatory setting~     without significant patient discomfort and with potentially significant cost savings.~      Office operative hysteroscopy (see and treat hysteroscopy) reduces the distinction between a~     diagnostic and an operative procedure, shifting the focus in health care away from inpatient~     diagnosis and treatment. The development of smaller-diameter hysteroscopes with~     continuous-flow system features and working channels, through which operative instruments can~     be introduced, has made it possible to treat some uterine and cervical diseases without the~     traditional need for cervical dilation or general anesthesia.~      Use of specially designed hysteroscopic 5F mechanical instruments (e.g., scissors, biopsy~     cup, graspers, and corkscrews) has long been the only way to perform operative procedures in~     an ambulatory setting. However, although grasping forceps and scissors are excellent for~     treating adhesions, cervical polyps, and endometrial polyps smaller than or the same size as~     the larger endometrial polyps, or thick lesions (e.g., submucous fibroids) were difficult to~     treat successfully using such miniature, fragile instruments and without cervical dilation.~      An important technologic advance occurred in 1997 with the introduction of a versatile~     bipolar electrosurgery system dedicated to hysteroscopy, the Gynecare VersaPoint (Ethicon,~     Inc., Somerville, NJ, USA), which represents a key point in the history of office operative~     hysteroscopy. With the use of 5F bipolar electrodes, the number of pathologic conditions~     treated using office operative hysteroscopy has increased tremendously, reducing the use of~     the resectoscope and the operating room to a smaller number of cases.~      More recently, a new generation of electrical generators, allowing the use of bipolar energy~     on miniaturized electrodes, has been presented (Autocon 400 II; Karl Storz Endoscopy,~     Tuttlingen, Germany). The main advantage of these instruments is that they are reusable,~     thereby reducing the costs of office operative as those described for the Versapoint system.~      The feasibility of ambulatory uterine surgery is not just dependent on recent technological~     advances in instrumentation such as miniaturization of equipment, but also the favorable~     anatomical characteristics of the uterus itself. The sensitive innervations of the uterus~     originate in the myometrium and extend to the outer serosal surface, whereas the endometrium~     and any fibrotic tissue within the cavity are less sensitive. Thus, procedures can be carried~     out without the use of analgesia or anesthesia.~      However, a careful operative technique is of paramount importance, in particular, avoiding~     inadvertent deep penetration of the superficial myometrium when resecting lesions such as~     polyps, maintaining the lowest possible distension pressures, and expediting procedures~     through efficient surgical techniques.~   "
23046|NCT03265288|"~     An International Phase II, double-blind, randomized, placebo-controlled study to evaluate the~     safety and efficacy of LAU-7b administered once-daily for 6 months for the treatment of CF.~   "
23047|NCT03265275|"~     At our institution, hip fracture patients are admitted and treated according to a fast track~     patient pathway. The aim of this study is to identify areas of this patient pathway that can~     be improved. To achieve this, the study will investigate the underlying reasons for the~     continued need for hospitalization on the consecutive days after hip fracture surgery.~   "
23048|NCT03265262|"~     Background: The need for an oral food challenge (OFC) surrogate is growing in line with the~     continuous increase in the prevalence and severity of paediatric food allergy. The basophil~     activation test (BAT) has recently been reported as a promising tool for predicting the~     outcome of OFC in children.~      Objective: We make the hypothesis that BAT might improve the sensitivity of food allergy~     diagnosis and spare part of current OFC in paediatric patients attending allergy departments~     in Marseille APHM University hospitals.~      Methods: BAT will be performed in parallel with OFC in 100 paediatric patients receiving OFC~     during a diagnostic or follow-up procedure.~      Expected results: Good concordance of BAT and OFC results leading to potential OFC~     replacement by BAT in at least 50% of the study population~   "
23049|NCT03265249|"~     Auricular neurostimulation is a potential novel and non-invasive method of pain control~     following liver transplantation in a growing patient population with the probability of~     significant impact on economics and morbidity. The investigator propose a pilot study to~     investigate the effects of auricular neurostimulation in patients receiving a liver~     transplantation. The investigator will investigate the effects of auricular neurostimulation~     with this novel device and compare it to the current standard of care for pain management~     following liver transplantation.~   "
23050|NCT03265236|"~     The aim of this work is to evaluate the diagnostic value of anti-MCV antibodies in rheamatoid~     arthritis patients and to correlate its relationtion disease activity and manifestations.~   "
23051|NCT03265223|"~     Pain still remains a limiting factor in early discharge of patients undergoing laparoscopic~     cholecystectomy. Almost all earlier studies done to compare the efficacy of local~     anaesthetics used intraperitoneally as compared to intraincisionally used equal amounts of~     drugs at the two locations, usually 10-20 ml. Using this large amount of drug in the small~     space of intraincisional location as compared to similar amount of drug in large~     intraperitoneal space created an inadvertent bias in favor of patients receiving the drug~     intraincisionally so such patients naturally experienced less pain. The investigators decided~     to standardize the drug used at these two locations as 1ml/cm and conduct a new study~     comparing the effects of drugs in relieving pain when used at these two locations.~   "
23052|NCT03265210|"~     Chronic pain and depression frequently co-exist in late and mid-life and contribute to~     increased disability, high health care costs, psychiatric comorbidity, and suicide. The~     investigators will recruit 60 adults from two randomly assigned large WCMA primary care~     practices; one practice will offer Relief (a 9 session behavioral intervention) and the other~     will offer referral for mental health care.~   "
23053|NCT03265197|"~     Importance; Tinnitus is a heterogeneous diagnosis that may occur alone, in the presence of~     hearing loss or as a component of other disorders and can be quite disabling. Intratympanic~     injections of medications recently proved to have role in management of tinnitus. The~     investigators report on our experience with the use of intratympanic injection of Lidocaine~     as local anesthetic which potentiate the action of dexthamesasone in treatment of tinnitus~     without adding potential risks of inner ear Objective; to describe the effect of Lidocaine as~     local anesthetic may potentiate the action of dexthamesasone intratympanic injection in~     treatment of tinnitus without adding potential risks of inner ear Design, Setting,~     participants ; For this single tertiary center( Tanta University Hospital ) prospective case~     series, the investigators included 44 patients divided into two groups (A and B) 22 patients~     in each group suffering from tinnitus between March 2015 and October 2015 Intervention; Under~     local anesthesia 22 patients were subjected to intratympanic injection with combined~     Lidocaine 2% and dexamethasone with ratio (1:1), in the group A, and 22 patients in the other~     group B were subjected to intratympanic injection with dexamethasone only , this process was~     repeated 3 times for 3 successive weeks.~      Main Outcome and Measures; the primary outcome is self-reported significant improve in~     tinnitus in group A more in group B without adding significant damage of inner ear~   "
23054|NCT03265184|"~     Metabolic syndrome (Mets) is defined as the collection of risk factors contributing to type 2~     diabetes mellitus and cardiovascular disease. Mets is accompanied by oxidative stress and~     low-grade inflammation. Green coffee is rich in polyphenols called chlorogenic acids (CGA)~     which possess anti-inflammatory and anti-oxidative characteristics. Thus, we carried out this~     trial to examine green coffee extract (GCE) effects on oxidative stress, systemic and~     vascular inflammation in patients having Mets~   "
23055|NCT03265171|"~     These are single-patient studies with repeat-dose administration of ProMetic Plasminogen IV~     infusion in one adult and one child with hypoplasminogenemia. These patients are under~     treatment to address wound healing and obstructions.~   "
23057|NCT03265145|"~     The primary objective of this pragmatic study is to compare the time to first moderate or~     severe COPD exacerbation in patients, not controlled on their current therapy, randomized to~     Stiolto Respimat versus triple therapy over 12 months of treatment~      The secondary objectives of this study include:~        1. To compare the annual rate of moderate or severe COPD exacerbations for patients on~          Stiolto Respimat with patients on triple therapy.~        2. To compare the time to first severe COPD exacerbation in both treatment arms.~        3. To compare the annual rate of severe COPD exacerbations in both treatment arms.~        4. To compare the proportion of patients with moderate or severe COPD exacerbations in both~          treatment arms.~   "
23058|NCT03265132|"~     The aim of this study is to demonstrate the efficacy and to evaluate the safety,~     pharmacokinetics (PK) and immunogenicity of anakinra in patients with newly diagnosed Still's~     disease, including SJIA (Systemic juvenile idiopathic arthritis) and AOSD (Adult-onset~     Still's disease).~   "
23059|NCT03265119|"~     This is PART A of a 2-part, 6-week, double-blind, dose-optimization, parallel-group study in~     children and adolescents (ages 6-17 years) with ADHD with and without CNVs in specific genes~     implicated in glutamatergic signaling and neuronal activity. Parts A will include subjects~     determined to have a specific gene mutations implicated in glutamatergic signaling and~     neuronal connectivity.~   "
23060|NCT03265106|"~     This is a single arm, open-label, uni-center, phase I/II study to determine the safety and~     efficacy of an experimental therapy called BinD19 cells in childhood patients with B-cell~     acute lymphoblastic leukemia or lymphoma, who are chemo-refractory, relapsed after allogeneic~     SCT, or are otherwise ineligible for allogeneic stem cell transplant.~   "
23061|NCT03265093|"~     Platelet Rich Fibrine (PRF), which promotes wound healing by supporting angiogenesis,~     immunity and epithelial proliferation phases. over a decade has since past since PRF was~     developed and many clinicians now point to the potential use of a liquid version of PRF. a~     liquid injectable-platelet-rich fibrin (i-PRF) was developed by modifying spin centrifugation~     forces. At lower centrifugation speeds and by utilizing non-glass centrifugation tubes, the~     fibrin coagulation could be slowed down at early time points thus generating an injectable~     PRF. Much like traditional PRF, i-PRF contains an increase in leukocyte number and is further~     able to stimulate growth factor release.~      Lichen planus is a common chronic mucocutaneous inflammatory disorder which generally affect~     s middle aged adults. Therapeutic methods including topical and systemic corticosteroids for~     the treatment of oral lichen planus (OLP) are suggested. However, long~      -term use of corticosteroids may be associated with local and systemic complications, and~     moreover, some patients may not be responsive.~      The investigators aimed to apply a treatment of autogenous origin (including no foreign~     products), considering the side effects of our corticosteroids. The study was designed as a~     split mouth.~      The investigators planned to administer I-PRF to one side and intralesional corticosteroid~     therapy to the other side at patients with bilateral atrophic / erosive oral lichen planus~     lesions~   "
23062|NCT03265080|"~     This is a phase 1, open-label, uncontrolled, multicenter study in 3 distinct solid tumors.~     The study design is dose-escalation/de-escalation using a standard 3 + 3 design to evaluate~     the safety profile of ADXS-NEO, to select a recommended phase 2 dose (RP2D), and identify~     initial signs of clinical activity in each of the 3 tumor-specific cohorts.~   "
23063|NCT03265067|"~     This is a before and after observational study of a therapeutic strategy to treat patients~     with confirmed ST-segment myocardial infarction (STEMI) with remote ischemic conditioning~     (RIC) before undergoing primary percutaneous coronary intervention (PCI). RIC is the~     purposeful application of brief, intermittent cycles of limb occlusion by inflation/deflation~     of a pneumatic cuff. The autoRIC device is an automatic RIC delivery device (the autoRIC®~     Device; CellAegis Devices Inc, Toronto, ON) that has received clearance from Health Canada~     for this use under the direction of a health care professional. Paramedics in the Peel and~     Halton regional emergency services and the Emergency department (ED) staff of Brampton Civic~     Hospital and Mississauga Hospital will treat patients experiencing STEMI with autoRIC, and~     study data will be collected from existing patient records.~      The 'before' group will include up to 900 patients who were treated before autoRIC~     implementation in the services and hospitals. These patients would have had a STEMI and~     undergone PCI, but did not receive the autoRIC device. The 'after' group will include up to~     900 eligible patients who have had RIC treatment with the autoRIC device at the two~     participating sites following implementation in the services and hospitals.~      The primary analyses will compare the short-term and long-term outcomes of eligible patients~     who have received completed primary PCI for STEMI in the time period before the~     implementation and following the implementation of this RIC strategy. In addition, a health~     economic analysis will be conducted to determine the cost-effectiveness of the therapeutic~     strategy to treat STEMI patients with RIC prior to PCI.~   "
23064|NCT03265054|"~     Venous thromboembolism (VTE) including deep vein thrombosis (DVT) and pulmonary embolism (PE)~     affects about 1,200,000 individuals each year in Europe. About 50% of VTE are unprovoked and~     20% of these patients will face a recurrent event after the usual three to six‐month course~     of anticoagulant treatment. To date, most patients are given prolonged anticoagulant~     treatment. However, anticoagulant treatment are associated with a major risk of bleeding~     (3%/year). Thus an accurate identification of patients with unprovoked VTE with a low risk of~     recurrence is needed to avoid unnecessary anticoagulant treatment with a risk of bleeding.~      Over the past few years, microparticles (MPs) which are small vesicles originating from the~     budding of cellular membranes have emerged as important biological entities regulating~     hemostasis. MPs expose at their surface procoagulant molecules such as phosphatidylserin and~     tissue factor (TF). All data obtained in mouse models support a role of MPs in venous~     thrombosis mediated by the TF activation. Moreover, results from clinical studies showed that~     TF-MPs was associated with the risk of venous thrombosis. However, the predictive value of~     TF-MPs in the recurrence of VTE is unknown. Besides, no study has taken into account the~     recent progresses in the understanding of the role of MPs in haemostasis. Indeed, MPs~     vectorize molecules which are not only procoagulant but also profibrinolytic. The net result~     depends on a balance between both activities (the coagulo-lytic balance). This balance is can~     be measured by two complimentary assays on MPs.~      We hypothesized that the coagu-lytic balance of MPs is associated with an increased risk of~     VTE recurrence after stopping the anticoagulant treatment.~   "
23066|NCT03265028|"~     Antibiotic resistance is a worldwide health care problem. Increasing use of antibiotics is~     associated with an increase in the prevalence of bacteria resistant to the antibiotic used.~     Reducing antibiotic use can be effected by improving antibiotic prescribing quality in two~     complementary ways. One is to limit antibiotic prescribing to those patients who will benefit~     from the treatment and two is to prescribe these patients the recommended antibiotic.~      International research has shown that a web-based communication training for the prescriber~     combined with an interactive booklet containing relevant patient information (Genomics to~     combat Resistance against Antibiotics for Community acquired LRTI in Europe INternet Training~     for Reducing antibiOtic use (GRACE INTRO)) can significantly and safely reduce antibiotic~     prescribing in adults presenting to primary care with acute cough/lower respiratory tract~     infections (LRTI). Quality assessment of antibiotic prescribing for respiratory infections in~     general practice has revealed the use of far too many (broad-spectrum) antibiotics in~     Belgium.~      In the proposed project, the investigators aspire to make Belgium the first European country~     to implement the most cost-effective part of the GRACE INTRO intervention (Translational~     Research on Antimicrobial resistance and Community-acquired infections in Europe (TRACE)~     e-learning, www.acutecough.org) at national level and to perform a scientifically sound~     assessment of the nationwide implementation on outpatient antibiotic use and societal cost.~   "
23067|NCT03265015|"~     This project seeks to identify causal neural mechanisms underlying unwanted, repetitive~     behaviors (compulsions). Using non-invasive brain stimulation coupled with practice in a~     computer task, we will modulate activity in a target brain region in two directions (up or~     down) and measure effects on compulsive behaviors and related measures. This work could~     ultimately lead to the ability to treat compulsions more effectively by targeting the regions~     of the brain that can help or hinder attempts to overcome compulsions.~   "
23068|NCT03265002|"~     The aim of the study is to investigate how dietary fibre combinations affects gut physiology,~     particularly colonic gas production. Comparisons will be made between a single fermentable~     fibre (inulin), a non-fermentable fibre (psyllium) and a combination of the two. The study~     will also explore differences in response between diarrhoea-predominant and~     constipation-predominant IBS (IBS-D and IBS-C) respectively.~      The participants will have a preliminary meeting to ensure they are eligible, then will~     attend the MRI department on 4 occasions separated by at least 1 week. They will ingest a~     drink with the fibre product mixed in, and will have 8 MRI scans (each lasting approximately~     15 minutes).~   "
23069|NCT03264989|"~     The purpose of the CSEG101A2202 study is to characterize the PK and PD of SEG101 at 5 mg/kg~     and to evaluate the safety and efficacy of SEG101.~      Study CSEG101A2202 is designed as a Phase II, multicenter, open-label study. Up to 45~     patients (to identify 27 evaluable patients) will be enrolled to the treatment group~     crizanlizumab 5.0 mg/kg to complete full PK/PD sampling at week 1 and week 15. In all~     patients, trough PK/PD samples will also be collected prior to each dose. In addition,~     throughout the study (and when possible), all patients will have blood drawn for serum to~     assess PK and PD drawn at times of onset and resolution of each VOC event, fever, or~     suspected infection. Once the up to 45 patients are enrolled, 10 additional patients will be~     enrolled to the exploratory treatment group and begin at 7.5 mg/kg of crizanlizumab.~   "
23070|NCT03264976|"~     Diabetic retinopathy (DR) is one of the most common causes of blindness worldwide. It is a~     progressive disease and its detection in early phases is very crucial for visional outcomes.~     miRNA of exosomes has been recently considered as a potential circulating marker of~     oculopathy, including age-related macular degeneration and uveal melanoma. Therefore, the~     primary objective of this study is to evaluate whether the serum exosomal miRNA could be~     prospective prognosis biomarker to investigate the initiation and development of DR. This~     case-control study is planned to include diabetic patients, and patients without DR, which~     serve as controls. Other participants will be divided into four groups by different DR stages~     according to the guideline from AAO. Information and samples of all trial participants will~     be collected at the inception of the study, including basic information, medical history,~     serum samples, and several ophthalmologic examinations. Then these information and~     examinations will be collected at regular intervals: every 12 months until 5 years. Different~     statistical methods will be used to identify significant associations between DR progression~     and different exosomal miRNA. We hypothesis that there could exist alert level of exosomal~     miRNAs which indicate the onset and development of DR in diabetic patients. Moreover, the~     selected exosomal miRNAs, being considered together with other information including medical~     history, blood indicators and ophthalmologic examinations, to be chosen-optimized as a~     prognostic model for DR, which may help predicting high risk groups of DR and those with poor~     prognosis. Based on clinical trial data, we will further discuss about possible roles of~     identified miRNA of exosomes in the pathogenesis of DR.~   "
23071|NCT03264963|"~     The objective of this study is to reduce the incidence or intensity of snoring in a patient~     population of known simple snorers without sleep apnea using smartphone based application~     which allows participants to play voice controlled games using various articulations~     resulting in tongue base movements.~   "
23072|NCT03264950|"~     Diagnosis of hepatic fibrosis is challenging as specific tests for detection of fibrosis in~     pediatric Cystic Fibrosis associated liver disease (CFALD) have not been developed and~     existing investigations do not correlate well with presence or severity of disease. Using a~     Liver biopsy it is difficult to diagnose this condition because of the patchy nature of the~     disease. Investigators intend to identify hepatic and pancreatic fibrosis in Cystic Fibrosis~     patients using Elastography and correlate this with their biochemical markers as well as~     histological findings of patients who have undergone liver biopsy for diagnosis of CFALD.~   "
23073|NCT03264937|"~     This is a prospective, observational, randomized controlled trial~   "
23087|NCT03264755|"~     Cortical excitability and role of repetitive transcranial magnetic stimulation in nicotine~     use disorder. Estimation of cortical excitability in heavy smoker patients and determination~     of role of repetitive transcranial magnetic stimulation for reducing nicotine craving.~   "
23132|NCT03264170|"~     This study will evaluate if providing women diagnosed with an intrauterine pregnancy of~     uncertain viability with a percentage likelihood of ongoing viability of their pregnancy at~     the time of the follow-up ultrasound, will result in improved psychological well-being~     (reduced anxiety and depression). Recruited women will be randomised to either receive the~     prediction score (intervention arm) or not (control arm).~   "
23074|NCT03264924|"~     Cardiac rehabilitation is a programme of exercise and health advice for people recovering~     from heart disease. Pulmonary rehabilitation is a similar programme for people with chronic~     lung disease. For both groups of patients, taking part in rehabilitation can lead to~     improvements in health and well-being. However, only 30% of patients complete their agreed~     rehabilitation programme. This costs the NHS millions of pounds every year. This project aims~     to investigate whether a motivational-based intervention, underpinned by self-determination~     theory and motivational interviewing, will enable staff to encourage more patients to take~     part in physical activity (PA). Staff will be trained with the new communication skills and~     will then deliver the rehabilitation programme. The session content will not change, just the~     way in which staff speak to patients.~      This will be a two-phase study. Phase A will take a qualitative approach collect patient and~     staff feedback about the current rehabilitation programme, before using this information to~     develop and pilot the intervention. Phase B will then assess the feasibility of the~     intervention within cardiac and pulmonary rehabilitation. Participants agreeing to take part~     in the phase B will be required to complete an interview and questionnaire at three time~     points. Patients' personal opinions of the programmes will be extremely important in~     discovering what can be done to improve rehabilitation for future participants.~      The main objectives will be to look at whether the intervention increases the number of~     patients taking part in physical activity. The investigators plan to establish how much~     physical activity patients take part in whilst they are in rehabilitation, as well as once~     they have left the programme. This is why participants will be interviewed three and six~     months after they have finished their rehabilitation programme.~   "
23075|NCT03264911|"~     Evaluate the necessity to treat with antibiotics GAS pharyngitis in children in Switzerland.~     The null hypothesis is that antibiotic treatment is not necessary for GAS pharyngitis in this~     population.~   "
23076|NCT03264898|"~     Colorectal cancer is a preventable and/or a treatable cancer, but at least 43% of the United~     States population is not up-to-date with screening. Although 90% of colorectal cancer~     screening is done using colonoscopy, most other countries use fecal immunochemical tests,~     reserving colonoscopy for those with a positive fecal immunochemical test. This project will~     provide the foundation for a paradigm shift for colorectal cancer screening in the United~     States by identifying how well 5 different FITs work for detecting screening relevant~     neoplasia, thus reducing morbidity and mortality for colorectal cancer.~   "
23077|NCT03264885|"~     Elderly with visual impairment (VI) who undergo community eye screening often do not attend~     tertiary follow-up even if significant eye diseases are detected. Investigators evaluate an~     incentive-care scheme (ICS) to improve the attendance rates of tertiary eye-care visits of~     participants following community eye screening.~   "
23078|NCT03264872|"~     The main purpose of this project is to test whether Peer-Enhanced Motivational Interviewing~     (PMI) results in superior alcohol and marijuana use outcomes for emerging adults (EAs, ages~     18-29) and their peers. Ninety peer dyads (total n = 180, ntarget client = 90, npeer = 90)~     are randomized to receive either Peer-Enhanced Motivational Interviewing (PMI) or Waitlist~     Control (WC).~   "
23079|NCT03264859|"~     The aim of this study is to investigate the association between NGAL plasma levels in~     ST-elevation myocardial infarction and the no-reflow phenomenon, adverse events during~     hospitalization and at 30-day follow-up.~   "
23080|NCT03264846|"~     Periodontal diseases are chronic inflammatory disease occurred by the interaction between~     pathogenic microorganism and the host defense. Polycystic ovary syndrome (PCOS) is a~     reproductive and metabolic disease associated with increased risk of cardiovascular events.~     Endocan is a proteoglycan secreted mainly by endothelial cells under the control of~     inflammatory cytokines.~      Periodontal diseases, including gingivitis, are common chronic infectious diseases caused by~     predominantly pathogenic microorganisms that colonize the subgingival area and cause local~     and systemic elevations of proinflammatory cytokines such as Interleukin-6 (IL-6).~      Several lines of evidence established the association between periodontal and systemic~     diseases, including metabolic syndrome, diabetes, and cardiovascular disease.~      Because of the fact that both periodontal disease and PCOS are associated with systemic~     inflammation and insulin resistance, these two disorders may be linked through a common~     pathophysiologic pathway.~      A number of studies have indicated a possible relationship between PCOS and periodontal~     inflammation. Despite common risk factors, including oxidative stress, the relationship~     between chronic periodontitis (CP) and PCOS remains unclear.~      The aims of the study were to determine serum and saliva Endocan and IL-6 levels and to~     evaluate the correlation between these two biomarker in women with periodontal disease and~     PCOS.~   "
23081|NCT03264833|"~     Purpose The purpose of this feasibility study is to assess the accuracy and precision of the~     Temp-Traq thermometer for monitoring body temperature in adult patients under three~     conditions (hypothermia, normothermia, and hyperthermia).~      Specific Aims~        1. To assess the accuracy of the Temp-Traq thermometer as compared to a gold standard (Core~          temp measured by Pulmonary Artery Catheter)~        2. To assess the precision of the Temp-Traq thermometer over repeated measures~        3. To determine if accuracy &/or precision is consistent in three conditions (hypothermia,~          normothermia, or hyperthermia)~   "
23082|NCT03264820|"~     At the digital level, the diagnosis of obstructive arteriopathy is very difficult in the~     absence of ulcer or of true ischemic signs, and the arteriography, which is an examination to~     inject an intra-arterial contrast agent, is the reference measure.~      The measure by Laser Doppler uses a monochromatic light (laser) to measure the~     concentration as well as the speed of travel of red blood cells in the skin and deduct the~     cutaneous blood flow.~      The great advantage of this technique is that it is non-invasive, inexpensive and can be~     performed during a consultation. The patient can therefore be briefly informed of the benign~     (functional) or organic origin of his disorders.~   "
23083|NCT03264807|"~     The purpose of this study is to compare the survival rate according to the presence or~     absence of 14v lymph node dissection.~   "
23084|NCT03264794|"~     1. Gefitinib CTTQ production gefitinib and erlotinib sheet AstraZeneca imatinib sheet~          (trade name: Iressa ®) comparison, human pharmacokinetics and relative bioavailability~          of comparative studies which examine people in vivo pharmacokinetic behavior, provide~          the basis for clinical use.~        2. Evaluation CTTQ gefitinib imatinib sheet production efficacy and safety of Chinese~          patients with locally advanced or metastatic non-small cell lung cancer.~   "
23085|NCT03264781|"~     The purpose of this study is to determine that once-a-month injectable contraceptive(~     Cyclofem® ) has the effect on treatment of irregular uterine bleeding in implant~     contraceptive users or not.~   "
23086|NCT03264768|"~     This a single center non-randomised non-sham controlled intervention study evaluating the~     effectiveness and safety of endoscopic lung volume reduction by endobronchial valves~   "
23101|NCT03264573|"~     The Objectives of this randomized controlled trial aiming to establishing a protocol of post~     scar revision care and to Study the effect of PRP and/or Adipose derived Mesenchymal Stem~     cell injection in improvement of atrophic scar after scar revision.~   "
23088|NCT03264742|"~     Patients are assigned to KSW's Stroke Unit as part of the emergency treatment. There the~     patients are included in the study and treated according to the concept on the Stroke Unit~     within the complex treatment. The patients are included after clarification and with the~     consent of the patients. On the morning after the day of intake, the first determination of~     the ghrelin takes place in the routine blood sampling. Similarly, 48 hours later and 3 months~     after the stroke, a blood sampling is performed to determine ghrelin. The De Morton Mobility~     Index (DEMMI), the 9-hole-peg assay and the modified Rankin Scale (mRS) are determined on the~     day of admission, on the 3rd day, and three months after stroke. This is done within the~     framework of the routine clarification and treatment on the Stroke Unit.~   "
23089|NCT03264729|"~     This study investigates the acute effect of isotonic versus isometric exercise versus walking~     on pain in individuals with plantar heel pain and an ultrasound-diagnosed plantar~     fasciopathy. The hypothesis is that isometric exercise will induce greater participant rated~     pain relief than isotonic exercise and walking during aggravating activity.~   "
23090|NCT03264716|"~     Colorectal cancer is the third most frequently diagnosed cancer and the third leading cause~     of cancer related deaths in Taiwan. Of the 10,248 new colorectal patients diagnosed each year~     approximately 60% will develop liver metastasis during the course of their disease. In~     approximately 30% of these patients who develop liver metastasis the metastatic disease will~     remain confined to the liver.~      For the 70-75% of colorectal patients with colorectal liver metastasis not suitable for~     hepatic resection or similarly ablative therapy with curative intent, systemic chemotherapy~     is the standard initial management. However, after a patient has failed first- line and in~     some cases second-line chemotherapy, response rates fall to as low as 12% (Chen HX 2006).~     Transarterial chemoembolization (TACE) with microsphere is an alternative treatment because~     normal liver tissue receives most of its blood supply from the portal vein, while colorectal~     liver metastases derive most of their flow from the hepatic artery. Several clinical trials~     have explored the feasibility and the efficacy of TACE with microsphere as a treatment for~     patients with colorectal liver metastasis. HepaSphere represents a novel drug delivery system~     for chemoembolization, which can add two benefits to embolization therapy. First, by~     ionically binding the doxorubicin throughout the microspheres, more drug can be delivered~     into the tumor, with less escape into peripheral circulation. Second, conformability to the~     architecture of the vessel lumen, providing more contact surface area with the embolic~     material and the vessel intima, leading to a more complete occlusion. However, there are~     limited experiences in using HepaSphere TACE for colorectal liver metastasis in Taiwan. In~     this pilot study, we will evaluate the initiate safety and efficacy of Hepasphere~     microspheres loaded with a chemotherapeutic agent doxorubicin for the treatment of patients~     who have failed first-line and second-line systemic chemotherapy.~   "
23091|NCT03264703|"~     This study will be conducted to observe the disease activity change of Conventional Disease~     Modifying Anti-Rheumatic Drugs (cDMARD) plus anti-tumour necrosis factor (anti-TNF) from~     baseline to 6 months compared with cDMARDs, as measured by the disease activity score with~     the erythrocyte sedimentation rate (DAS28-ESR).~   "
23092|NCT03264690|"~     This study will be conducted to observe the difference in microbiome composition between~     healthy participants and inflammatory bowel disease (IBD) participants with no anti-tumor~     necrosis factor (anti-TNF) treatment.~   "
23093|NCT03264677|"~     -  To investigate the product regiments' performance on moisturization related skin healthy~          signs (skin moisturization, barrier function, elasticity, translucency, roughness and~          skin conditions) through instrumental evaluation, clinical grading and self-assessment~          before, during and after 8 weeks' home usage under city environmental aggressors (Sun,~          change of temperature and humidity, wind and air pollution) among 3 product regimens and~          Non-treatment control;~        -  To explore the linkage among products efficacy, ambient aggressors, and life habits;~        -  To investigate product regimens' tolerance and safety via Home Use Test;~        -  To collect skin microflora/microbiome samples for potential research on skin microbiome~          distribution change as impacted by product application and/or environmental aggressors~          change (data will be analyzed and reported separately).~   "
23094|NCT03264664|"~     This study will be conducted to assess the safety/tolerability profile of E7386 as a single~     agent administered orally in participants with selected advanced or recurrent neoplasms and~     to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of~     E7386.~   "
23095|NCT03264651|"~     To evaluate the impact of a selective androgen receptor modulator combined with an aromatase~     inhibitor in reducing high mammographic breast density.~   "
23096|NCT03264638|"~     This study evaluates the effects and biological mechanisms of Dingkundan，Diane-35 and the~     combination of Dingkundan and Diane-35 in the treatment of polycystic syndrome(PCOS) in~     adults women. One third of participants will receive Dingkundan capsules, one third of~     participants will receive Diane-35 Pills, and the another third will receive Dingkundan~     capsules and Diane-35 in combination.~   "
23097|NCT03264625|"~     This is a pilot randomized, controlled trial of Vitamin D supplementation in patients on~     peritoneal dialysis and to explore if oral administration of vitamin D3 could reduce the risk~     of subsequent Peritoneal dialysis-related (PD-related) peritonitis and improve the prognosis~     of peritonitis~      Aims of the study are to:~        1. To examine the effect of vitamin D supplementation on the risk for peritonitis among~          patients on peritoneal dialysis.~        2. To explore the effect of vitamin D supplementation on the prognosis of peritonitis.~   "
23098|NCT03264612|"~     Each female sets her experience of 47 manifestations on a 6 point scale separately for the~     premenstrual, menstrual and intermenstrual phases of her latest and worst menstrual cycle.~     Daily Symptoms Report was filled at the start and at end of the study (before and after~     performing swimming exercise) Females in group I were instructed to engage into swimming~     exercise 30 minutes daily, 3 times weekly for 3 months. Exercise was ceased on the first 3~     days of menstrual cycle then resumed afterwards.~      The exercise included three stages: warming up, swimming and cooling down.~   "
23099|NCT03264599|"~     2D trans abdominal ultrasound was done during the first stage of labor. If fetal position is~     occiput anterior and fetal presentation is vertex, two dimensional sagittal picture of the~     fetal head and upper spine was acquired and stored in the ultrasound machine. On this image,~     the offline measurement of the angle formed by a line tangential to the occipital bone and a~     line tangential to the first vertebral body of the cervical spine (occiput-spine angle) will~     be performed to quantify the degree of fetal head flexion in respect to the trunk~   "
23100|NCT03264586|"~     Included women were divided randomly into two groups:~      Group A: (n=100): women were subjected to application of EMLA® cream Lidocaine-prilocaine~     cream (EMLAcream; Astra Zeneca, Basiglio, Italy is an entectic mixture of 2.5% lidocaine and~     2.5% prilocaine)for pain relief during episiotomy repair.~      Group B: (n=100): women were subjected to application of local injection of 10 ml of 1%~     mepivacaine for pain relief during episiotomy repair.~   "
23102|NCT03264560|"~     There is a critical shortage of psychiatric services to people with mental illness who live~     in Skilled Nursing Facilities (SNFs), especially those in rural settings. Although real-time~     video conferencing psychiatric consultation, termed Synchronous Telepsychiatry (STP), has~     been around for almost 3 decades, its adaptation is met with logistic and other challenges.~     In this context, the investigators investigate a novel method of psychiatric consultation~     termed Asynchronous Telepsychiatry (ATP). The main hypotheses are that that ATP will be as~     clinically effective as STP, and that it will be acceptable to patients. This study aims to~     evaluate the comparative clinical effectiveness of ATP vs. STP in SNF population, in a~     12-month non-inferiority, randomized, controlled trial.~   "
23103|NCT03264547|"~     To verify that combination therapy with trastuzumab + pertuzumab + eribulin brings similar~     PFS and better QOL compared to trastuzumab + pertuzumab + taxane in advanced/recurrent~     HER2-positive breast cancer patients who have no medical history of chemotherapy except~     ado-trastuzumab emtansine~   "
23104|NCT03264534|"~     Astigmatic keratotomy (AK) is used to treat numerous refractive disorders, including~     congenital astigmatism, residual corneal astigmatism at the time of or following cataract~     surgery, post-traumatic astigmatism, and astigmatism after corneal transplantation.~      Within the past few years, much consideration has been given to an evolutionary variant of~     the procedure, the limbal relaxing incision (LRI). By moving the incision farther to the~     periphery, cataract surgeons can safely and predictably remediate mild to moderate amounts of~     regular astigmatism at the time of cataract surgery by performing this incisional technique.~      Recent technological developments have shifted ophthalmologist's attention from manually~     created LRIs and astigmatic keratotomy procedures to femtosecond laser-guided procedures.~     Femtosecond lasers offer superior incisional accuracy and reproducibility coupled with~     minimal effects on collateral tissues, achieving levels of safety and reproducibility~     exceeding those of mechanical techniques. A major clinical application of the femtosecond~     laser is for creating arcuate incisions that have a precise and accurate length, depth,~     angular position, and optical zone.~   "
23105|NCT03264521|"~     The study aims to advance pain research by exploring feasibility of crowdsourcing patient~     pain data via Amazon Mechanical Turk, the largest and most studied crowdsourcing platform in~     the U.S. We will leverage an existing NIH/NCCIH grant as a comparison data (RAND Center of~     Excellence in Research on CAM; CERC) to conduct a feasibility study of new methods for~     gathering and analyzing data on chronic pain and engaging pain patients in health policy.~   "
23106|NCT03264508|"~     This study aims to determine the effects of 8-10 weeks of repeated hot water immersion (heat~     therapy) vs. thermoneutral water immersion on vascular function in late middle-aged to older~     (55-79 years) adults.~   "
23107|NCT03264495|"~     The objective of the study is to measure the quantities of food consumed at each meal by a~     representative part of the population of patients hospitalised in each department of the~     Champmaillot Geriatric Centre.~      To do so, the quantity eaten will be quantified by weighing the amounts served and~     subtracting the weight of the left-overs. These measurements will allow us to provide more~     appropriate meals in the second step.~   "
23108|NCT03264482|"~     the investigators plan to test Thulium laser vaporization using high power ( 200w ) Front~     fire vaporization compared to standard M-TURP in reduction of LUTS secondary to BPH in a~     prospective randomized trial.~   "
23109|NCT03264469|"~     Psychological trauma is a major public health concern that affects numerous patients who have~     experienced traumatic events.~      The objective of our research was to improve the diagnosis and management of persons~     experiencing such events.~      We will seek to determine factors brought into play in the construction of psychological~     trauma and the best way to identify them so as to implement the optimal management of~     patients and ensure recognition of this condition.~      In addition, in the context of our activity as expert witnesses, we will study the methods~     used to assess and quantify psychological trauma.~      In this respect, a medical appointment will be made by a nurse of the Forensic Medicine~     Department of Dijon CHU. During this consultation, a self-report questionnaire will be~     completed by the patient alone to evaluate the level of acute stress followed by a~     psychiatric consultation and completion of the IES-R questionnaire with the doctor to~     identify symptoms of psychological trauma.~   "
23110|NCT03264456|"~     There is great need for improved preoperative imaging in men with high-risk prostate cancer.~     Investigators propose to develop and validate an optimized simultaneous PET/MRI protocol for~     local, regional and whole body preoperative staging in a single imaging session using the~     amino acid PET tracer, F-18 fluciclovine. Despite advances in the diagnosis and treatment of~     prostate cancer, the preoperative staging of men with prostate carcinoma (PCa) is currently~     problematic. Conventional imaging is falsely negative for regional lymph node metastases in a~     substantial fraction of men. In particular, approximately 35% of men with high-risk prostate~     cancer will have biochemical recurrence even after optimal surgical resection. A major~     benefit of simultaneous acquisition of a multiparametric prostate MRI (mpMRI) and F-18~     fluciclovine PET includes having the patient undergo a single imaging study which provides~     both anatomic and molecular characterization of the tumor, including metastases which would~     potentially be missed by conventional anatomic imaging and size criteria. Additionally,~     simultaneous acquisition will improve co-registration of the PET and MR data which is~     valuable for small lesions and in anatomically complex regions. Although the use of~     fluciclovine in the characterization of the primary PCa remains to be established, the~     anatomic detail provided by conventional mpMRI will complement the detection of small volume~     metastatic disease by fluciclovine PET. Additionally, the use of hybrid PET/MRI technology~     allows for the assessment of dynamic tracer uptake and washout during the whole body and~     regional PET/MRI scan, which may demonstrate the ability to increase detection of the primary~     PCa on fluciclovine PET. If F-18 fluciclovine PET/MRI can reliably and accurately detect~     nodal metastases in high-risk prostate cancer patients, surgeons may use this new technology~     to develop new treatment algorithms for the optimal management of these patients.~   "
23111|NCT03264443|"~     Two-center randomized, parallel, controlled trial which will compare a pragmatic combined~     training program with a health education program in 184 older adults with hypertension. This~     study will last 12 weeks with assessments conducted at baseline, previously to the group~     allocation, and after interventions. There is a set of secondary outcomes which show clinical~     importance to the elderly population and are possibly influenced by the tested intervention.~   "
23112|NCT03264430|"~     Evaluation of the anesthetic quality and analgesic efficacy of adding ketamine to intrathecal~     bupivavaine in selective saddle block for perianal surgery.~   "
23113|NCT03264417|"~     A multicentric study to explore variability when clinicians are intrepreting lung function~     tests. Comparison with results of in-house built software for automatic interpretation.~   "
23133|NCT03264157|"~     A prospective, randomized, blinded, parallel-group, non-inferiority, phase II/III study of~     the pharmacokinetics and safety (and tolerability) of simulated post-exposure prophylaxis~     with BPL HRIG with co-administration of active rabies vaccine in healthy subjects.~   "
23114|NCT03264404|"~     The purpose of this study is to determine the effectiveness of combining immune therapy,~     pembrolizumab, with a hypomethylating agent, azacitidine, for pancreatic cancer. People who~     have advanced pancreatic cancer with disease progression on first-line therapy are usually~     treated with a second chemotherapy regimen. However, there is no single accepted chemotherapy~     regimen and national guidelines recommend chemotherapy or clinical trial participation. In~     this study, all study subjects will receive a combination of immune therapy (every 3 weeks)~     and a hypomethylating agent (every 4 weeks).To date, studies have shown that combining a~     hypomethylating agent with chemotherapy or immune therapy may benefit patients across~     different solid tumor types including pancreatic cancer. Preclinical data in a mouse model of~     pancreatic cancer demonstrates improvement in survival with the combination of a~     hypomethylating agent and immune therapy. However, the use of single agent hypomethylating~     agent or immune therapy has not been shown to be effective in patients with pancreatic~     cancer. The one exception, to date, is the use of immune therapy in those individuals with a~     particular genetic feature known as mismatch repair deficiency and microsatellite~     instability. The combination of immune therapy and a hypomethylating agent has not been~     studied in human subjects and is not approved by the FDA for use in pancreatic cancer.~      This is a non-randomized, single-center, open-label trial of pembrolizumab and azacitidine in~     subjects with locally advanced or metastatic pancreatic adenocarcinoma. Approximately 31~     individuals will be asked to participate in this study.~      Primary objective: To evaluate the progression-free survival per RECIST 1.1.~      Secondary Objectives:~        1. Safety Objective: To determine the safety and tolerability of induction therapy with~          azacitidine followed by pembrolizumab in advanced pancreatic cancer.~        2. To evaluate the objective response rate (ORR), duration of response (DOR), disease~          control rate (DCR), and time to progression (TTP) per RECIST 1.1, and overall survival~          (OS).~   "
23115|NCT03264391|"~     Behcet's disease is an important cause of retinal vasculitis and vision loss in Egypt.~     Fluorescein angiography is the standard method of diagnosis of retinal vasculitis. OCT~     angiography (OCT-A) is a recently developed method that can be used in the evaluation of~     retinal circulation. In this study, we will test the utility of OCT-A in diagnosis and follow~     up of retinal vascular changes in cases diagnosed with Behcet's disease that visit the~     outpatient uveitis clinic of Assiut University hospital, a major tertiary center in southern~     Egypt, over a one year duration. Also, correlation of OCT-A changes with visual acuity and~     hence prognosis will be described.~   "
23116|NCT03264378|"~     The Partnership in Implementation Science for Geriatric Mental Health (PRISM) project~     proposes an evidence-based physical exercise intervention for older adults who exhibit~     behavioral and psychological symptoms of dementia (BPSD). The proposed evaluation study will~     conduct a randomized controlled trial with a Hybrid Type 3 design to compare the intervention~     arm that implements the culturally-adapted GTO model (GTO-ThAI) to deliver implementation~     support, with a control arm, which receives usual top-down administrative instruction for~     implementing a policy initiative.~   "
23117|NCT03264365|"~     Relatives of intensive care patients are at risk of developing symptoms of anxiety,~     depression and post-traumatic stress disorder resulting in impaired health-related quality of~     life (HRQOL). Recovery programs have been tested, but its effectiveness is sparse. The~     hypothesis is that relatives to former intensive care patients will improve their HRQOL one~     year after intensive care. We want to determine whether relatives to former intensive care~     patient's benefits from a recovery programme with improved HRQOL, Sense Of Coherence (SOC)~     and symptoms of anxiety, depression and PTSD compared to standard care one year after~     intensive care.~   "
23118|NCT03264352|"~     Lowering of blood pressure (BP) in high-risk hypertensive individuals reduces major adverse~     cardiovascular (CV) events. Diabetic patients with hypertension benefit from BP lowering~     treatment. The present trial,IPAD in brief, is a randomized, double-blind,~     placebo-controlled, parallel-group, multicenter study involving 12,000 patients to be~     recruited over three years and to be followed up for a median of three years and a half. IPAD~     tests the hypothesis that antihypertensive medications in adults with type 2 diabetes, whose~     seated BP 130-149 mm Hg systolic and below 90 mm Hg diastolic, results in 35% difference in~     the incidence of stroke. During follow-up the sitting systolic pressure should be decreased~     both by at least 10 mm Hg and lower than 130 mm Hg, by titration and combination of the~     double-blind study medications of an angiotensin type-1 receptor blocker Allisartan (240~     mg/day), a dihydropyridine calcium-channel blocker (amlodipine 5-10 mg/day), and a~     hydrochlorothiazide (12.5-25 mg/day). In the placebo group, identical tablets will be used~     similarly.~   "
23119|NCT03264339|"~     Children with cerebral palsy (CP) have life-long motor disorders caused by brain injuries~     which occur around birth. These children go through extensive treatment during childhood, but~     the treatment has generally been started late due to late diagnosis (median age 15 months).~     New recommendations state that the clinical diagnosis high risk of CP should be given~     before 6 months corrected age, in order to be able to intervene as early as possible, and~     have the best possibilities to prevent or limit the adverse neurodevelopmental consequences~     of brain injuries occurring around birth. Thus, there is a great need to develop~     evidence-based early interventions for children at high risk of developing cerebral palsy.~      The Small Step program is developed at Karolinska Institutet (KI) in Stockholm, Sweden and is~     based upon theories of brain plasticity induced by early learning. The efficacy of the~     program is presently being investigated at KI. Preliminary results indicate a large~     individual variation in response to the program among the participating children.~      The aim of the present study is therefore to explore individual responses to the Small Step~     Program in infants at risk of developing cerebral palsy.~      The main hypothesis is that infant characteristics, such as severity of brain pathology, are~     associated with differential response to the program. Also, infants with absent fidgety~     movements and children with sporadic fidgety movements are believed to respond differently to~     the program.~   "
23120|NCT03264326|"~     The purpose of this randomized controlled trial is to use Shear Wave Elastography (SWE) to~     assess Achilles tendinopathy and the effectiveness of Blood Flow Restriction (BFR) training~     in patients with Achilles tendinopathy as measured by Numeric Pain Rating Scale, functional~     self-report, and objective functional measures. SWE will be utilized to objectively quantify~     tendon properties and BFR training and eccentric exercise will be utilized to treat Achilles~     tendinopathy.~   "
23121|NCT03264313|"~     The purpose of this study is to evaluate the efficacy and safety of dTMS used as a tool for~     the smoking cessation; therefore, the subjects will be randomized to be treated on the active~     group or to receive placebo stimulation.~   "
23131|NCT03264183|"~     Transesophageal echocardiography (TEE) is becoming a more prevalent method of monitoring and~     diagnosis in the perioperative setting for critically ill patients and patients undergoing~     cardiac surgery. Many TEE measurements are extrapolated from transthoracic echocardiography~     (TTE) data and have not validated by transesophageal means. The aim of this study is to~     validate TEE assessment of right ventricular function by comparing them to simultaneously~     measured TTE measurements.~      Likewise, there are currently no agreed upon values for RV free wall strain. Therefore, the~     investigators will attempt to define a range of normal values of RV free wall strain as~     compared to the other measures of RV function.~   "
23122|NCT03264300|"~     A critical aspect of brain tumor patient management is the radiographic assessment of tumor~     status, which is used for diagnosis, localization, surgical planning and surveillance. The~     primary goal is to develop and apply advanced, quantitative magnetic resonance imaging (MRI)~     techniques that can supplement existing high-resolution anatomic imaging to aid clinical~     decision-making for patients diagnosed with brain tumors. The studies proposed herein involve~     the development of advanced imaging methods that are intrinsically sensitive to the~     biophysical characteristics associated with tumor pathogenesis, as they are more likely to~     improve tumor characterization and localization and may offer early and more specific~     indicators of treatment response. These advanced methods include diffusion-weighted imaging~     (DWI), chemical exchange saturation transfer (CEST), and dynamic susceptibility contrast~     (DSC) perfusion MRI. A secondary objective of this study is to validate cerebral blood volume~     (CBV) metrics acquired using a DSC acquisition and post-processing methods by comparison with~     an intravascular reference standard contrast agent. Validated perfusion imaging techniques~     will improve the reliability and relevancy of derived CBV metrics across a range of clinical~     applications, including tumor localization, treatment guidance, therapy response assessment,~     surgical and biopsy guidance, and multi-site clinical trials of conventional and targeted~     brain tumor therapies.~   "
23123|NCT03264287|"~     This trial is designed to evaluate the efficacy of different frequencies in treating the~     moderate and severe acne vulgaris using acupuncture combined with moving cupping and ear~     point tapping.~   "
23124|NCT03264274|"~     Various antiangiogenic agents have a modest effect in prolonging overall survival in solid~     tumours. In colorectal cancer it is clear that there are some patients in whom bevacizumab~     significantly prolongs survival, but it is not effective in the majority of patients.~     Biomarker studies using tumour tissue and blood have failed to define a consistent biomarker~     that correlates with a beneficial effect of bevacizumab on survival. DCE-MRI can detect~     changes in tumour blood flow which, in early phase drug studies, correlated with subsequent~     tumour responses, but is too expensive and time consuming to be used in larger scale trials.~     DCE-US is a promising biomarker for use in this group of patients with antiangiogenic agents,~     as detailed above. The investigators wish to use this technique as a predictive biomarker for~     any effects Aflibercept has on OS and PFS in patients with metastatic colorectal cancer~     refractory to standard treatment.~   "
23125|NCT03264261|"~     To compare the effect of constraint induced movement therapy (CIMT) vs. treadmill training~     only on walking function in individuals post-stroke, a 6 week, single-blind, randomized~     training study will be conducted with three assessments of gait to determine the training~     effect. Subjects will be randomized to either the CIMT or treadmill training only groups at~     the initial test. Following the initial test, individuals from the 2 groups will undergo~     intensive locomotor training. Training will be performed 3 times per week for 6 weeks with~     the training time for each visit set to 45 minutes as tolerated. Data collection will proceed~     until 36 subjects from 2 groups have been trained.~   "
23126|NCT03264248|"~     The goals of the proposed study are to test the usability, feasibility and preliminary~     efficacy of the E-Scale with wheelchair users. The E-scale was developed as a weight~     monitoring technology for wheelchair users. Up to fifteen overweight or obese wheelchair~     users will be enrolled in a 13 week study that includes standard behavioral treatment (SBT)~     for weight loss, which focuses on diet, physical activity, and behavioral strategies (e.g.,~     goal setting, self-monitoring) to support lifestyle changes specifically for people with~     mobility impairments. The subjects will also be provided the E-scale to track their weight~     daily. The outcome measure include usefulness (subjective feedback from a survey about the~     program/E-scale), feasibility (accuracy and repeatable measurements from the E-scale) and~     efficacy (improvements in weight and other measures of health) of the weight loss program~     coupled with the E-scale at the end of 13 weeks. The primary hypothesis is that the E-scale~     coupled with the weight loss intervention will result in significant improvements in weight,~     abdominal girth, body fat percentage, and the Center for Epidemiologic Studies Depression~     Scale (CES-D).The results may inform the refinement of this technology to increase its~     applicability for wheelchair users to independently monitor their weight in their own homes~     while attempting to lose weight.~   "
23127|NCT03264235|"~     Hypothesis/Specific Aims: The purpose of this research study is to determine if using an~     exoskeleton during stair climbing training will result in an improved ability to walk and~     climb stairs in individuals affected by recent stroke as compared to stair climbing training~     without an exoskeleton.~   "
23128|NCT03264222|"~     Patients with implantable cardiac electronic devices will be exposed to a new safety device~     and evaluated for potential electromagnetic interference.~   "
23129|NCT03264209|"~     This study aims to examine whether Smart After-Care service (Internet-and mobile-based~     lifestyle intervention) has an effect on patients' satisfaction and clinical outcomes in~     patients with prostate cancer on androgen deprivation therapy. Patients with prostate cancer~     on androgen deprivation therapy will participate in the study. The study design is a~     randomized controlled trial. The patients were randomly assigned to intervention or usual~     care groups. Intervention patients received Smart After-Care service for 3 months. Primary~     endpoint was an increase in patients' physical function as assessed using 2 minute walking~     test. Secondary endpoints included improvement in muscle strength, short physical performance~     battery, body composition, and health-related quality of life.~   "
23130|NCT03264196|"~     The condylar head is the part of the lower jaw which forms the joint. Displaced fractures of~     this area are uncommon but can cause problems with function, such as chewing, if not treated~     effectively. The medical literature does not have a clear consensus on whether these should~     be treated operatively (with surgery to reduce and fix the fracture) or conservatively (with~     advice and exercise and no surgery). The investigators propose a randomised controlled trial~     comparing the outcome of the operative or conservative treatment of condylar head fractures~     of the mandible, primarily with regards to patient related outcome measures of mandibular~     function, and secondarily objective measures of mandibular movement, function and symptoms to~     try and provide a clearer answer as to the best way of managing them.~   "
23134|NCT03264144|"~     This study will examine the effectiveness of a social norms campaign in correcting smoking~     misperceptions, reducing smoking susceptibility and changing smoking-related behaviours in~     Hong Kong adolescents.~   "
23135|NCT03264131|"~     Adult T-cell leukemia/lymphoma (ATLL) is a rare form of cancer found mostly among people from~     the Caribbean islands, Western Africa, Brazil, Iran, and Japan. Most cases of this disease in~     the United States occur along the East Coast due to emigration from the Caribbean islands.~     There is currently no standard treatment for ATLL. Research shows that patients who go into~     first time remission (respond completely or partially to treatment) and have a bone marrow~     transplant have the best outcomes. Traditional chemotherapy treatments have generally not~     worked well in patients with ATLL. Additionally, not all patients will be eligible for a bone~     marrow transplant.~      The purpose of this study is to see how well individuals with ATLL respond to an~     investigational cancer treatment. This investigational treatment combines a drug called~     brentuximab vedotin with a standard chemotherapy treatment made up of cyclophosphamide,~     doxorubicin, etoposide, and prednisone. This treatment is considered investigational because~     it is not approved by the United States Food and Drug Administration (FDA).~      Brentuximab vedotin, also known as Adcetris, is approved by the United States Food and Drug~     Administration (FDA) for treatment of certain types of lymphoma in some patient populations.~     Brentuximab vedotin has not been approved by the FDA for treatment of ATLL.~      Brentuximab vedotin is an antibody that also has a chemotherapy drug attached to it.~     Antibodies are proteins that are part of the immune system. They can stick to and attack~     specific targets on cancer cells. The antibody part of brentuximab vedotin sticks to a target~     called cluster of differentiation 30 (CD30) that is located on the outside of the cancer~     cells. Normal cells have little or no CD30 on their surface. ATLL cancer cells often have a~     larger amount of CD30 on their surface than normal cells. However, CD30 is found in different~     amounts on ATLL cancer cells. This study will also test the amount of CD30 found on each~     participant's cancer cells. Researchers will be looking to see if the response to the study~     treatment varies based on the amount of CD30 found on the outside participants' cancer cells.~      Brentuximab vedotin has previously been combined in another study with a different standard~     of care chemotherapy regimen: cyclophosphamide, doxorubicin, and prednisone. The study~     included patients with various types of T-cell lymphomas. Two of the patients enrolled in~     that study had ATLL. Both had a complete response (no evidence of disease). The researchers~     in the current study (LCCC 1637) have added etoposide to the combination of brentuximab~     vedotin with cyclophosphamide, doxorubicin, and prednisone. They predict that the addition of~     etoposide will improve patient outcomes. Research shows that etoposide helps improve outcomes~     in patients with certain types of T-cell lymphomas who undergo chemotherapy treatment. This~     investigational combination of brentuximab vedotin with cyclophosphamide, doxorubicin,~     etoposide, and prednisone is called BV-CHEP.~   "
23136|NCT03264118|"~     The aim of this study is to evaluate the additional effect of antimicrobial photodynamic~     therapy regeneration treatment of mandibular furcation lesions when associated to bovine bone~     and porcine collagen membrane.~   "
23137|NCT03264105|"~     Pits and fissures have been considered as the single most important feature leading to the~     development of occlusal caries; About 90 % of carious lesions are found in the pits and~     fissures of permanent posterior teeth .Several materials and techniques have been developed~     to enhance the longevity of pit-and-fissure sealants, including the use of flowable composite~     resins as pit-and-fissure sealants~   "
23138|NCT03264092|"~     The study's aim is to prospectively compare three different tissue acquisition techniques~     during EUS guided pancreatic solid lesions biopsies.~   "
23139|NCT03264079|"~     This trial will study the impact of a strong CYP3A4 inhibitor (itraconazole) on the~     pharmacokinetics of bardoxolone methyl (RTA 402) in healthy adult subjects.~      This is an open-label, fixed-sequence crossover pharmacokinetic (PK) study in healthy~     volunteers.~      Subjects will complete a screening visit within 28 days of Study Day 1. Subjects must qualify~     for the study based on inclusion/exclusion criteria. For Period 1, all qualified subjects~     shall receive a single oral dose of bardoxolone methyl (10 mg) on Day 1. For Period 2,~     following a washout of 14 days, itraconazole (SPORANOX®) capsules (100 mg) will be~     administered as a 200-mg single daily dose on Study Days 15 through 27, with bardoxolone~     methyl (10 mg) administered on Day 18 (1 hour after itraconazole administration).~      Bardoxolone methyl doses will be administered under fasted conditions. Itraconazole will be~     administered under fed conditions on Study Days 15-17, and Study Days 19-27.~      On study Day 18, itraconazole will be administered under fasted conditions. Subjects will be~     confined beginning on Study Day -1 through the last blood sample collection on Study Day 9~     during Period 1, and from Study Day 14 through the last PK blood draw on Study Day 28 during~     Period 2.~   "
23140|NCT03264066|"~     This is a study to evaluate the efficacy, safety, and pharmacokinetics of cobimetinib plus~     atezolizumab in participants with advanced solid tumors including the following cohorts:~     squamous cell carcinoma of the head and neck (SCCHN), urothelial carcinoma, and renal cell~     carcinoma (RCC).~   "
23141|NCT03264053|"~     Buccal bone is prone to resorb after tooth extraction specially with immediate tooth~     implantation which could compromise the esthetics of the patient. socket shield technique~     retains the buccal aspect of the extracted root fragment which may help in preventing the~     buccal bone from resorbing and prevent esthetics deterioration~   "
23142|NCT03264040|"~     Development of a new MS-based biomarker for the early and sensitive diagnosis of Mannosidosis~     alpha from plasma~   "
23143|NCT03264027|"~     The objective of this randomized clinical trial is to compare pain levels during and after~     insufflation with carbon dioxide or in subjects that will undergo endoscopic fulguration with~     argon to reduce the diameter of the gastrojejunal anastomosis. The investigators hypothesize~     that carbon dioxide will be superior in causing less pain and leading to less discomfort.~   "
23144|NCT03264014|"~     This is an investigator-initiated, multinational, retrospective, non-interventional pilot~     study conducted in five haemophilia treatment centres from different geographical regions~     that maintain a local (Algeria, Malaysia) or national (India, Iran, South Africa) haemophilia~     registry. Data from a randomly selected sample of patients from national or local registries~     are anonymously collated and analysed.The aims are to determine the feasibility of combining~     data from national and local registries in countries with developing healthcare systems and~     to assess how existing registries implemented current recommendations for data collection in~     terms of available fields and their completion.~   "
23145|NCT03264001|"~     Type 2 diabetes results from a combination of peripheral insulin resistance and beta-cell~     dysfunction, and manifests as fasting and postprandial hyperglycemia. In Singapore, despite~     the relatively low prevalence of overweight and obesity, the prevalence of type 2 diabetes is~     disproportionately high and is expected to double in the near future. This indicates that~     insulin resistance and beta-cell dysfunction are widely prevalent even among individuals who~     are not overweight or obese. Still, weight loss induced by a variety of ways (calorie~     restriction, exercise, surgery, etc.) is considered the cornerstone of diabetes treatment.~     This underscores the importance of negative energy balance in improving metabolic function.~     In fact, negative energy balance induced by calorie restriction can improve metabolic~     function acutely, i.e. within 1-2 days and before any weight loss occurs. Likewise, negative~     energy balance induced by a single session of aerobic exercise improves metabolic function~     over the next few days. However, the magnitude of negative energy balance that needs to be~     achieved in order to improve metabolic function, as well as possible dose-response~     relationships, are not known. Furthermore, the comparative efficacy of calorie restriction~     vs. exercise in improving metabolic function has never been directly assessed.~      Accordingly, a better understanding of the effects of acute negative energy balance induced~     by calorie restriction or aerobic exercise on insulin sensitivity and beta-cell function will~     have important implications for public health, by facilitating the design of effective~     lifestyle (diet and physical activity) interventions to prevent or treat type 2 diabetes.~      To test these hypotheses, whole-body insulin sensitivity, the acute insulin response to~     glucose, and the disposition index (i.e. beta-cell function), will be determined the morning~     after a single day of progressively increasing negative energy balance (equivalent to 20% or~     40% of total daily energy needs for weight maintenance) induced by calorie restriction or~     aerobic exercise.~      Results from this project are expected to result in the better understanding of the effects~     of negative energy balance induced by diet and exercise on metabolic function. Therefore,~     this project may help in the design of effective lifestyle intervention programs for the~     prevention and treatment of type 2 diabetes.~   "
23160|NCT03263806|"~     This study is designed to directly compare Standard Care and CT fractional flow reserve~     (CTFFR) for diagnosis of chest pain patients with definite coronary artery disease (CAD) on~     heart computed tomography (CT) scans.~   "
23146|NCT03263988|"~     Measurement of arterial blood pressure is a basic monitoring in the perioperative setting. It~     is a standard monitoring to assure an adequate cerebral perfusion pressure and is a basic~     parameter of hemodynamic optimization. Until now standard methods for blood pressure~     measurement are non-invasive interval monitoring by arm cuff (Riva-Rocci) or direct,~     continuous and invasive by inserting an intraarterial catheter. This observational study will~     show, that a new non-invasive piezocapacitative-interlayer technology will make continuous~     blood pressure monitoring and non-invasive pulse contour analysis available.~   "
23147|NCT03263975|"~     The mechanism(s) by which dehydration (both intra- and extracellular) impairs performance are~     still poorly described. A loss of volume results in increased occurrence of orthostatic~     intolerance, including dizziness, fatigue, headaches and related symptoms with upright~     posture. Any of these symptoms can contribute to decreased performance in maneuvers performed~     in the upright posture, which includes many military tasks. Thus, loss of volume challenges~     the cardiovascular and blood pressure responses to systemic whole body endurance exercise,~     while osmolality is the stimulus for intracellular dehydration that may impair local muscle~     force production by impairing contractile function, neural signaling, or both. In this study,~     we will compare how both types of dehydration affect MSNA and CAC.~      The results of this study will provide mechanistic insight for how dehydration (intra- or~     extracellular) impairs systemic whole body and local small muscle performance in vivo. This~     Basic Science study seeks to understand how volume and osmolality impact MSNA and CAC as a~     basis for improving potential countermeasures, such as a more optimally formulated~     rehydration beverage. Therefore, this study directly complements Task Area T10 (Hot Weather~     Operations and Hydration: Injury and Performance Optimization) and impacts virtually all 14~     Military Operational Medicine Research Program Drivers.~   "
23148|NCT03263962|"~     To evaluate canrenone effects compared to other therapies on cardiovascular mortality in~     patients with congestive heart failure and preserved systolic function after 12 years of~     evaluation.~   "
23149|NCT03263949|"~     Predict-VT is an investigator-initiated, prospective, observational clinical trial. Six~     hundred patients with ST elevation acute myocardial infarction (STEMI) undergoing primary~     percutaneous coronary intervention (PPCI) will be included. The primary end point is a~     composite of ventricular tachyarrhythmia (VTA) and sudden cardiac death (SCD). VTAs will be~     recorded using continuous electrocardiographic (ECG) monitoring in the coronary unit for the~     first 72 hours, standard ECG and ECG holter monitoring. For the analysis of myocardial~     function, conventional 2D echocardiography and tissue doppler will be used. For the~     evaluation of myocardial mechanics, 2D speckle tracking, strain, strain rate and mechanical~     dispersion will be obtained. Important clinical, laboratory and angiographic variables will~     also be examined. Patients will be followed-up at 6 months, 1, 2 and 4 years. The optimal VTA~     prediction model will be constructed using logistic regression and bootstrap models. Patients~     who experience primary end point should undergo secondary SCD prevention using implantable~     cardioverter defibrillator (ICD). Patients with left ventricular ejection fraction (LVEF) <~     35%, 40 days post acute myocardial infarction (AMI), will be candidates for primary SCD~     prevention.~   "
23150|NCT03263936|"~     This is a pilot study using decitabine and vorinostat before and during chemotherapy with~     fludarabine, cytarabine and G-CSF (FLAG).~   "
23151|NCT03263923|"~     CWRU Research Study: Looking for grandmothers living with grandchildren, 18 years of age or~     younger, to take part in a study to compare methods of dealing with the stress of caregiving~     to grandchildren. Participants need to have daily access to a computer, complete four surveys~     online, and be willing to write in a journal every day for a month. Participants will be~     compensated for their time.~   "
23152|NCT03263910|"~     Chinese patients who require gastrointestinal endoscopy will receive an intra-gastric single~     dose of NPO-11 20ml. The superiority of NPO-11 compared to placebo as a premedication for~     endoscopy will be verified in a randomized, double-blind, parallel-assignment design based on~     the proportion of patients having no gastric peristalsis.~      The safety of NPO-11 will be evaluated based on adverse events and adverse drug reactions~     observed between informed consent and 7 days after administration in comparison with the~     placebo group.~   "
23153|NCT03263897|"~     Evaluate the feasibility of using a mobile interface to control the insufflator device~     administering treatment for aborting (stopping) an acute episode of migraine. The patient,~     under clinical supervision, will use the mobile interface to self administer the treatment~     when experiencing an acute episode of migraine. The supervising clinician will monitor the~     patient and the device to make sure that no harm could come to the patient and will be ready~     to intervene if any adverse effects were suspected to or in the process of happening.~   "
23154|NCT03263884|"~     The main purpose of the study is to assess the mechanisms of repeated sessions of repetitive~     trancranial magnetic stimulation (rTMS) applied on left dorsolateral prefrontal cortex on the~     development of pain in a prolonged muscle pain model.~   "
23155|NCT03263871|"~     The purpose of this study is to assess the effectiveness of PTM202 in treating environmental~     enteric dysfunction.~   "
23156|NCT03263858|"~     Assessment of the safety and clinical performance of a coronary stent system in de novo~     coronary artery lesions~   "
23157|NCT03263845|"~     Observational study.~   "
23158|NCT03263832|"~     This is an observational study that does not change routine care.~      The primary objective of this study is to investigate the correlation between the~     administration of an antibiotherapy able to prevent biofilm formation according to the~     results of the Antibiofilmogramme test, and the relapse of the infection for patient with~     orthopaedic device-related infection.~   "
23159|NCT03263819|"~     Patients with POTS experience significant gastrointestinal symptoms. Current evidence~     suggesting that abnormal post-ganglionic sympathetic function could play a role in the~     pathophysiology of these GI abnormalities. Sympathetic fiber regulate motor and the~     postprandial GI peptides secretion.~      The focus of the present proposal is to determine glucose homeostasis, GI motility, and their~     association with GI and cardiovascular symptoms in POTS patients versus healthy controls.~     Furthermore, we will determine differences in these outcomes in POTS patients with and~     without evidence of postganglionic sympathetic fiber neuropathy.~      As a long-term goal, this study can lead us to understand the pathophysiology of common~     co-morbidities in patients with POTS to provide new treatment approaches and prevention~     strategies.~   "
23161|NCT03263793|"~     The overall goal of this T2 translational research project is to pilot an interdisciplinary~     high-intensity group singing program to improve speech and swallowing in patients with~     Parkinson's Disease (PD) and to explore the impact of this program on quality of life (QOL).~     This research has three specific aims: 1) Determine the effects of a high-intensity group~     vocal training program on vocal function and laryngeal structure; 2) Determine the~     transference of vocal training to laryngeal aspects of swallowing; 3) Determine the effect of~     patient-reported changes in Quality of Life (QOL) as the result of participation in a group~     vocal training program.~      Twenty patients with Parkinson Disease will be recruited from the Fresco Institute for~     Parkinson's & Movement Disorders to participate in a 12-week vocal training program. The~     program will train participants using maximum vocal function exercises targeting vocal~     deficits specific to PD. Choral singing therapy sessions will be conducted once weekly with~     daily home practice exercises based on principles that have been successful in other~     intensive PD vocal exercise programs.~   "
23162|NCT03263780|"~     This prospective trial aims to determine if enhanced prostate imaging using two novel imaging~     technologies (high resolution DWI and 18F-fluciclovine PET-MRI) will detect prostate cancers~     not seen on standard multiparametric prostate MRI in patients considered candidates for focal~     HIFU.~   "
23163|NCT03263767|"~     Acute or chronic graft versus host disease is still the major complication of stem cells~     transplantation regarding morbidity and mortality.~      Recently, high dose cyclophosphamide utilization early after post-transplantation (day+ 3 and~     +4) not only for patients with HLA- haploidentical donor but also for patients with Human~     Leukocyte Antigen (HLA)-compatible donor, showed a great control of graft versus host disease~     after transplantation, allowing to consider stopping immunosuppressive treatment after the~     transplantation (Neoral=cyclosporine, cell-cept=mycophenolate mofetil). Indeed, this step has~     already been completed in myeloablative transplantation in adult patients.~      This approach could enable to avoid in the end several complications related to long term~     immunosuppressive drugs administration, while promoting quicker immunity recovery.~   "
23164|NCT03263754|"~     This study aims to assess the efficacy of Pocket Medic to promote self-management and~     pulmonary rehabilitation adherence in COPD patients.~   "
23165|NCT03263741|"~     Explore the Efficiency and Safety of Paclitaxel + S-1 + Oxaliplatin (PSOX) Chemotherapy in~     the Patients with Locally Advanced or Advanced Gastric Cancer~   "
23166|NCT03263728|"~     The aim of this study is to determine the prevalence of myocardial ischaemia in asymptomatic~     high risk type 2 diabetic patients using stress cardiac MR and how many stress cardiac MR~     examinations are false positive.~   "
23167|NCT03263715|"~     The purpose of this study is to assess the efficacy of a tocilizumab-based regimen compared~     with placebo on top of rapidly tapered glucocorticoid treatment in a double- blind,~     controlled fashion, focussing on glucocorticoid-free remission of disease.~   "
23168|NCT03263702|"~     This prospective, multicenter, observational study will examine the ability of real time~     electrogram processing mapping to identify driver domains to target for ablation in~     persistent AF patients.~   "
23169|NCT03263689|"~     Many counties in sub-Saharan Africa have very limited post-operative nursing capacity, and~     relatively little data have been published about post-operative maternal pain control in~     these settings. Cesarean section is the most common type of major operation at our~     institution, Mbarara Regional Referral Hospital (MRRH), in south-western Uganda.Nursing ward~     staffing capacity is low, with much basic nursing care provided by families and friends of~     patients. The investigators conducted a study to examine the impact of ITM versus TAP block~     in a setting of limited formal nursing oversight.~   "
23170|NCT03263676|"~     This is a randomized cross over trial to compare quality of life and product performance~     between Icon reusable underwear versus standard disposable pad in patients with mild to~     moderate urinary incontinence.~   "
23171|NCT03263663|"~     In this exploratory phase II trial, the possibility of a personalized treatment after~     resistance to cetuximab will be evaluated. Therefore, tumor material of all patients shall be~     obtained, transferred into avatars and treated the same way as in the patient until~     resistance arises. These resistant tumor cells are subsequently treated by different targeted~     treatment combinations in the mouse avatar model to find the most active drug or combination~     of drugs. This drug or combination of drugs may then be offered to the patient after~     cetuximab resistance has occurred. Multiple liquid biopsies shall be obtained in patients~     during first‐line treatment with cetuximab as well as during second line experimental~     treatment to monitor mutations that may be associated with cetuximab resistance. Furthermore~     at the time of resistance a biopsy should be taken and analyzed to ensure that the mechanism~     of resistance seen in the avatar model matches with the mechanism of resistance in the~     individual patient.~   "
23172|NCT03263650|"~     The goal of this clinical research study is to learn if olaparib, when given after treatment~     with cabazitaxel, carboplatin, and prednisone, can help to control aggressive variant~     prostate cancer (AVPC). The safety of these drugs will also be studied.~      This is an investigational study. Cabazitaxel and carboplatin are FDA approved and~     commercially available for the treatment of certain types of prostate cancer. Prednisone is~     FDA-approved and commercially available as a corticosteroid. Olaparib is FDA approved and~     commercially available for the treatment of certain types of ovarian cancer. The combination~     of cabazitaxel and carboplatin followed by olaparib in this study is investigational.~      The study doctor can describe how the study drugs are designed to work.~      Up to 96 participants will be enrolled on this study. All will take part at MD Anderson.~   "
23173|NCT03263637|"~     The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK),~     pharmacodynamics (PD) and preliminary antitumor activity of AZD4573 in subjects with relapsed~     or refractory haematological malignancies~   "
23174|NCT03263624|"~     Nail psoriasis has a high incidence amongst patients with psoriasis.It is estimated to affect~     80% of psoriatic patients at some time during their lives and has a significant adverse~     influence on their quality of life.~      Treatment of nail psoriasis is disappointing, as it is refractory to treatment, with~     conventional therapies often having little effect.~   "
23175|NCT03263611|"~     This clinical trial evaluate the safety, tolerability and exploratory efficacy of targeted~     single injection of AMG0103 in subject with chronic discogenic lumbar back pain~   "
23176|NCT03263598|"~     The low sodium intake is important for ascites control in liver cirrhosis patients.~     Therefore, World Health Organization (WHO) recommends reduction of sodium (Na) to 2g/day for~     adults. The 24-hour urine Na excretion has been regarded as a standard method to estimate the~     amount of daily dietary sodium intake. However, it is too inconvenient to apply to patients~     or the general population in practice. For this reason, it has been suggested that a spot~     urine Na/potassium (K) ratio could be replaced with the 24-hour urine Na excretion. However,~     the evidence is not sufficient for that. The investigators will evaluate the usefulness of~     spot urine Na/K ratio to estimate the dietary sodium intake. The investigators will also~     verify several formulas of estimating the 24-hour Na excretion with spot urine Na, K,~     Creatinine (Cr).~   "
23177|NCT03263585|"~     Background: Back pain and osteoporosis with vertebral fractures are common conditions in~     elderly women and significantly affect their quality of life. A common complication of~     osteoporosis are vertebral fractures. Treatment with bone-specific drugs does often not help~     the pain condition caused by the vertebral fractures even when the progress of the disease~     has decreased. Vertebral fractures often result in deformation of the spine and poorer~     quality of life of the individual. The spinal kyphosis also affects the lung function and the~     effect of the kyphosis itself is severe. Alternative treatments of back pain may lead to~     reduced drug demand for pain. Physical activity is one of the most important factors that~     regulates bone mass and can also affect balance and fall risk positively. The back orthosis~     that we intend to use in the treatment study has been shown in some previous scientific~     studies to strengthen the muscles in the back and also decrease the pain.~      Purpose: The purpose of the study was to evaluate the effect of treatment of back pain in~     elderly women with an activating functional orthosis versus treatment with a group of~     physiotherapeutic tools and a control group for a six-month treatment period and follow-up~     after 12 months from the start of study. The aim was also to study elderly women with~     osteoporosis and back pain in a follow-up study of a cohort of women at high risk of~     osteoporotic fractures, with focus on back pain, functional capacity and quality of life.~      The aim was to study the effect of treatment with activating functional orthosis versus~     physiotherapeutic treatment in a group and a control group without treatment. The main~     outcomes will be the experienced perceived back pain and back extensor strength. Additional~     outcomes will be quality of life, balance, lung function and kyphosis. Biochemical markers~     for pain will be measured in the RCT (Randomized Controlled Trial).~      Significance: Evaluation of alternative treatment methods such as exercise by a~     physiotherapist and treatment with a functional orthosis will give new additional treatment~     options for our patients. An activating functional orthosis could reduce the use of~     analgesics and increase the quality of life of the affected women.~   "
23178|NCT03263572|"~     The goal of this clinical research study is to learn if the combination of blinatumomab and~     ponatinib can help to control Philadelphia chromosome-positive acute lymphoblastic leukemia~     (Ph+ ALL); BCR-ABL-positive ALL; or ALL that has come back (relapsed) or has not responded to~     treatment (refractory). Ph+ and BCR-ABL positive are types of genetic mutations (changes).~     The safety of this drug combination will also be studied.~      This is an investigational study. Blinatumomab is FDA approved and commercially available for~     the treatment of other types of ALL. Ponatinib is FDA approved and commercially available for~     the treatment of several types of leukemia, including some types of Ph+ ALL. It is~     investigational to use the study drugs in combination with each other.~      The study doctor can describe how the study drugs are designed to work.~      Up to 60 participants will be enrolled in this study. All will take part at MD Anderson.~   "
23179|NCT03263559|"~     This is a Phase II, single arm, multi-center trial, designed to estimate the efficacy and~     toxicity of haploidentical bone marrow transplantation (BMT) in patients with sickle cell~     disease (SCD). Based on their age and entry criteria patients are stratified into two groups:~     (1) children with SCD with strokes; and (2) adults with severe SCD.~   "
23180|NCT03263546|"~     The purpose of this study is to investigate if therapist-guided internet-delivered cognitive~     behavioral therapy (ICBT) in a stepped-care approach is an effective and cost-effective~     treatment in reducing OCD symptoms for children and adolescents compared to gold standard~     treatment (face-to-face CBT).~   "
23181|NCT03263533|"~     The main goal of this pilot study is to test the extent to which adjunctive treatment with~     the histone deacetylase (HDAC) inhibitor vorinostat improves brain plasticity and cognition~     in a pilot placebo-controlled trial in patients with schizophrenia who are on clozapine.~   "
23182|NCT03263520|"~     Compare the use of nandrolone associated with corticosteroid for the treatment of~     cancer-induced malnutrition to treatment with corticosteroids alone in patients with tumors~     in the high gastro-intestinal tract, liver, pancreas and bile ducts in palliative treatment.~   "
23183|NCT03263507|"~     The purpose is to assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of~     IONIS-PKK-LRx administered subcutaneously to Healthy Volunteers~   "
23184|NCT03263494|"~     Adolescents and young adults with T1D and poor glycemic control (age 14-< 25 years, T1D~     duration >12 months, HbA1c 7.5-<11.0%, using an insulin pump or MDI)) will be randomly~     assigned to either CGM or BGM. Sample size will be 150. The primary outcome assessment will~     be HbA1c after 6 months. Secondary outcomes will include HbA1c, CGM metrics (control group~     will wear blinded CGM at 13 and 24 weeks), and quality of life measures. The randomized trial~     will be followed by a 6-month extension study during which the RCT control group will~     initiate CGM and the RCT CGM group will continue CGM.~   "
23185|NCT03263481|"~     The aim is to evaluate the peak secretory flow rates and bicarbonate concentrations as~     determined by a 30 minute intraductal secretin stimulation test in patients with a low~     likelihood of pancreatic pathology and to compare these data to those obtained from our~     historical patients with suspected chronic pancreatitis. These will be patients in which~     inadvertent pancreatic cannulation occurs during therapeutic endoscopic retrograde~     cholangiopancreatography (ERCP) for biliary indications . All study subjects will receive a 5~     day follow-up phone call. Enrollment goal is 36 subjects.~   "
23186|NCT03263468|"~     This study is being conducted in patients with a major heart attack caused by a blocked~     artery undergoing Percutaneous Coronary Intervention (PCI) to open up the blockage. Up to 50%~     of people with an heart attack are found to have one or more additional narrowings that did~     not cause the heart attack. At present the best way to manage these additional blockages is~     not known. Many cardiologist recommend opening these blockages at at a later time after the~     heart attack. The present study is examining if PCI of all blockages at the same time as the~     PCI for the artery that caused the major heart attack (SS-PCI) will reduce the amount of~     heart damage compared to performing PCI of additional blockages 2-45 days later (IRA-PCI).~     Clinical follow up will be completed at 3, 12 and 24 months to determine heart function and~     monitor adverse events.~   "
23205|NCT03263221|"~     Statistical analysis for adult patients who were admitted to Assiut university hospital~     within one year with proximal femoral fractures.~      Protocol of management include lines of treatment , hospital stay and results~   "
27098|NCT03212300|"~     This is a randomized study to examine whether aerobic exercise training (AET) before total~     shoulder replacement (TSR) surgery reduces the incidence of post-operative delirium (POD) and~     shorten time to recovery in elderly patients. POD is a form of sudden change in mental~     function that could be experienced after undergoing surgery.~   "
23187|NCT03263455|"~     Stroke is the second leading cause of death worldwide and the third most common cause of~     disability. The effects of stroke are variable and may include impairments in motor and~     sensory systems, emotion and neuropsychological deficits such as a disorder of spatial~     awareness known as unilateral spatial neglect (USN). Approaches to ameliorate USN could be~     categorized in interventions as involving either bottom-up or top-down processing. The~     specific mechanisms underlying these effects on a number of manifestations of the USN~     syndrome may include the restoration of defective representations of the side of space~     contralateral to the lesion (contralesional), and of the ability to orient spatial attention~     contralesionally, through complex patterns of activation of both the damaged right~     hemisphere, and the contralateral left hemisphere, with differences related to the specific~     stimulation delivered to the patient. In recent years, increasing cutaneous stimuli through~     neuromuscular kinesiotaping has been proposed to enhance somatosensory inputs (24) and such~     as method could have positive effects on USN. The aim of the present study was to assess the~     effect of KTM applied on the sternocleidomastoid muscle controlateral side of the lesions in~     improving USN deficits in individuals with stroke patient in sub-acute phase. The hypothesis~     is that the KTM application could improved cognitive tests for assessing USN, motor deficits~     and kinesthetic neck sensibility.~   "
23188|NCT03263442|"~     Purpose: To conduct a randomized controlled pilot study investigating the use of high dose~     intravenous (IV) thiamine to prevent delirium and mitigate the long-term effects of delirium,~     including health-related quality of life (HRQOL), functional status, and neuropsychiatric~     outcomes, in patients admitted to University of North Carolina (UNC) Hospital for allogeneic~     hematopoietic stem cell transplant (HSCT).~      Participants: 60 adult inpatients admitted to the UNC Bone Marrow Transplant Unit for~     allogeneic stem cell transplant.~      Procedures (methods): Participants will be admitted for allogeneic HSCT and on the day after~     transplant randomized to seven days of high dose IV thiamine or placebo. Thiamine levels will~     be measured weekly and participants will be assessed for evidence of delirium using validated~     measures. Validated measures will also be used to assess cognitive function, depression,~     post-traumatic stress symptoms, functional status, and HRQOL prior to hospitalization and at~     one, three, and six months after transplant.~   "
23189|NCT03263429|"~     This phase I/II trial studies the best dose and side effects of glutaminase inhibitor CB-839~     and how well it works with panitumumab and irinotecan hydrochloride in treating patients with~     RAS wildtype colorectal cancer that has spread to other places in the body and does not~     respond to treatment. Glutaminase inhibitor CB-839 may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as~     panitumumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in~     chemotherapy, such as irinotecan hydrochloride, work in different ways to stop the growth of~     tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them~     from spreading. Giving glutaminase inhibitor CB-839 with panitumumab and irinotecan~     hydrochloride may work better in treating patients with colorectal cancer.~   "
23190|NCT03263416|"~     This is a prospective, comparative, open label, randomized, multicentric study evaluating the~     benefit of a dedicated and coordinated follow-up on treatment adherence in patients with~     metastatic solid tumor and starting a first cycle of treatment compared to standard~     follow-up. A dedicated and coordinated follow-up during the treament period will be based on~     a telephone follow-up and a pharmaceutical conciliation.~      Patients will be randomized into one of two study arms:~      Arm A (Experimental follow-up): coordinated follow-up performed by a dedicated nurse and a~     pharmaceutical conciliation made by the Center Pharmacist.~      Arm B: Standard follow-up during the treatment period.~      Patients will be followed during 6 months.~   "
23191|NCT03263403|"~     This study will be a randomized observer -blinded controlled non-inferiority study to~     evaluate and compare the immunogenicity of locally produced Ingovax ACWY with Quadri Meningo~     on a total of 88 healthy adult participants (18-45 years of age). 44 participants will~     receive locally produced Ingovax ACWY and 44 participants of comparator groups will receive~     Quadri Meningo which is produced by BiO-MeD Private Limited. Vaccination will be done in Day~     0 following the screening and pre-immunization blood sample collection and post-immunization~     blood will be collected at Study Day 30. Follow- up by home visit will be carried out from~     Study day 1-6 and clinic follow-up is scheduled upto Study day 90. The hypothesis of this~     study is: locally produced subcutaneous Meningococcal vaccine Ingovax ACWY is non inferior~     and immunogenic among adults in Bangladesh as compared to Quadri Meningo.~   "
23192|NCT03263390|"~     This study aims to characterize the neurological basis of obesity and response to surgical~     and medical treatment by inducing adult pluripotent stem cells into neuronal cells from~     subjects that have demonstrated extreme response to bariatric surgery or pharmacological~     treatment for obesity.~   "
23193|NCT03263377|"~     In order to improve child nutrition, the Poverty Reduction Strategy adopted by the Government~     of Bangladesh (GoB) has called for the initiation of a school feeding programme for primary~     school children living in poor and disadvantaged families and communities where the~     prevalence of child malnutrition is high. Accordingly, a pilot feeding programme is planned~     for implementation in Government and NGO schools in 10 Upazilas in rural Bangladesh with the~     aim of: 1) enhancing the nutritional status and growth of younger school-going children by~     reducing micronutrient deficiencies and providing a protein/calorie supplement; 2) improving~     learning capacity and attentiveness in the classroom; 3) increasing enrollment, attendance~     and completion rates and 4) supporting the goals of achieving universal primary education and~     reducing gender disparity.~      The objectives of the proposed baseline survey respond to GoB's aims:~        1. To assess the nutrition status of younger school-going children prior to the initiation~          of a school feeding programme, thus enabling the later assessment of programme impact on~          micronutrient deficiencies and anthropometric indicators.~        2. To assess the cognitive performance and school attendance of children prior to the~          initiation of a school feeding programme thus enabling the later assessment of programme~          impact on school enrollment and attendance, and learning capacity.~      The baseline study will be conducted using a cluster randomized study design in which schools~     represent clusters. Seven schools will be randomly selected from each of 7 Upazilas out of 10~     that have been selected for intervention. A control group will be included in study design~     consisting of 7 schools selected randomly from 7 comparable yet adjacent Upazilas not slated~     for inclusion in the feeding programme. Use of a control group will enable later evaluations~     to attribute possible improvements in key impact/outcome variables to the intervention~     itself. A mid term evaluation will be conducted 6 months after the baseline survey. Finally,~     an impact evaluation will be conducted on the same children 10-14 months after the baseline~     survey.~   "
23194|NCT03263364|"~     Unexplained polycythemias are rare diseases, and therefore, the collection of data inherent~     to these diseases will not only improve their characterisation, but also allow stratification~     according to the risks and the course of the disease. The objective of this project is to~     constitute a database on the disease which will allow us to better understand it and in due~     course improve its management.~      The GENRED project thus bears uniquely on the collection of information, which will be~     gathered throughout the usual management of patients for this type of disease.~   "
23195|NCT03263351|"~     There has been a rise in type 2 diabetes (T2D) rates in adolescents, disproportionately in~     girls from disadvantaged racial/ethnic groups. This group of girls also is at heightened risk~     for depression, and depression and T2D are linked. Depressive symptoms are a risk factor for~     worsening of insulin sensitivity, one if the major precursors to T2D. In preliminary studies,~     the investigators found that a brief cognitive-behavioral therapy group decreased depressive~     symptoms and prevented worsening of insulin sensitivity in adolescent girls at-risk for T2D~     with moderate depressive symptoms. The aims of this study are: 1) to assess the efficacy of a~     cognitive-behavioral therapy depression group vs. a health education control group for~     improving insulin sensitivity and preserving insulin secretion in racially/ethnically diverse~     adolescent girls at-risk for T2D with moderate depressive symptoms over a 1-year follow-up;~     2) to evaluate changes in eating, physical activity, and sleep as explanatory and 3) to test~     changes in cortisol factors as explanatory.~   "
23196|NCT03263338|"~     The purpose of this research study is to see if we can help parents to get their children to~     go to bed earlier. This may help children to improve their sleep. The study will use a~     web-based study platform and an activity monitor.~   "
23197|NCT03263325|"~     Acute kidney injury (AKI) is common in children after cardiac surgery with a reported~     incidence of 20-40%. Pediatric AKI has been found to be associated with important short and~     long-term adverse outcomes.~      A major challenge to management of AKI after cardiac surgery and cardiopulmonary bypass is~     the lack of early diagnostic markers. Current diagnostic criteria for AKI in children relies~     exclusively on elevation of serum creatinine concentration and oliguria. Both of these~     markers lack sensitivity and specificity, and result in delayed detection of kidney injury.~      This study aims to determine if UDP-glucose can be used as a urinary biomarker to detect~     subclinical acute kidney injury following pediatric cardiac surgery with cardiopulmonary~     bypass.~   "
23198|NCT03263312|"~     This is a single center prospective longitudinal exercise training study and will enroll~     approximately 50 Fontan patients and 20 controls of a similar age, gender, BMI and physical~     activity level between the ages of 10-40 years.~      Participants will undergo an MRI of the Fontan circulation. This will include imaging of the~     heart, lung and liver. This will include specific imaging for tissue characterization and~     assessment of myocardial fibrosis, liver fibrosis and disproportionate pulmonary blood flow.~     The investigators will then draw blood (approximately 10 ml) for assessment of serum~     biomarkers and circulating microRNAs of interest. The participants will undergo exercise~     testing and will then start a 3-6 month long cardiac rehabilitation program. After the 3-6~     month study period the participants will return back for a follow up and repeat all the~     testing completed at enrollement.~   "
23199|NCT03263299|"~     Ovarian stimulation will be done using the Microdose flare-up regimen. The patient will~     receive diluted doses of the GnRH agonist leuprolide acetate 40 µg, given subcutaneously~     twice daily. Two days later, stimulation will be initiated by intramuscular (IM) injections~     of HMG (Merional, IBSA, Germany) in a dose of 300 IU/day.~      Follicular monitoring began from the ninth day of the cycle by serial vaginal ultrasonography~     and measurement of serum E2 levels. IM injections of 10000 IU HCG (Choriomon; IBSA, Germany)~     will be injected when at least 2 follicles 18 mm were observed on ultrasonography.~      Oocytes willbe retrieved 36 hours after hCG injection using a 17-gauge aspiration needle~     under transvaginal ultrasound guidance. The pelvis is evaluated with ultrasound to ensure~     that there is no internal bleeding.~      After fertilization was confirmed when two polar bodies and two pronuclear were observed~     18-20 hours after insemination, one to three grade A embryos were transferred at day 3~     fertilization.~      The luteal phase support will be initiated from the day of oocyte retrieval for all patients~     with (Cyclogest 400 mg, Actavis pharmaceutical, UK) vaginal suppositories per day till the~     day of serum pregnancy test was done.~   "
23200|NCT03263286|"~     This research will evaluate the potential for a novel hand orthosis (HandSOME) to help stroke~     victims regain functional use of their hand and regain independent living. Participants will~     use the HandSOME at home regularly for 8 weeks. Clinical evaluations will measure changes~     from the intervention after the 8 weeks and also at a 3 month followup.~   "
23201|NCT03263273|"~     To evaluate the efficacy of once-daily application of 1% and 3% HY01 Topical Gel, as assessed~     by the change in inflammatory lesion count from baseline over the 12-week treatment period in~     patients with moderate-to-severe papulopustular rosacea.~   "
23202|NCT03263260|"~     Post-marketing, prospective, multicentric, non-randomized registry to evaluate the safety and~     efficacy of Inspiron Sirolimus Eluting Coronary Stent at the treatment of real-world~     patients.~   "
23203|NCT03263247|"~     The current project aims to investigate the efficacy of the visual imaging training (VIT) and~     alphabet search training in comparison to an active control intervention, namely~     psychoeducation information (PI) using fMRI in patients with amnestic mild cognitive~     impairment (MCI) and healthy elderly controls (HE). MCI patients will be grouped according to~     biomarkers (PET PIB, PET FDG and liquor).~   "
23204|NCT03263234|"~     Europe is undergoing a demographic change with a rapidly growing population of 65 years+.~     This challenges municipalities and hospitals as the ageing citizens need care and treatment~     due to an age-related decline in physical and mental capacity. Therefore municipalities are~     experiencing a growing need for sufficient and customized housing, which can support the~     elderly citizens in sustaining well-being and health along with preventing functional~     decline. Well-fare technologies, such as Circadian adjusted LED-based lighting (CALED), are~     suggested as a remedy for this.~      To obtain proper visual sharpness and better contrast, people of older age require heightened~     light levels due to age-related failing vision. Furthermore, inappropriate light at night~     disrupts not only sleep but also the timing of the circadian rhythm, with negative~     consequences on cognition and emotions. Therefore CALED is being increasingly considered for~     use in hospitals and elderly housing because of its wide spectrum of wavelengths, good~     contrast and fast switching, and possibility to support a normalised circadian rhythm.~      Lighting based on LED has been shown to improve the quality of sleep and to improve~     well-being in the elderly. However, it is not known whether CALED mimicking a normal~     circadian rhythm has the same benefits for elderly persons with frailty or dementia. The~     investigators therefore want to test the effects of CALED in elderly people with frailty and~     mobility disabilities and/or dementia living in elderly housing. The investigators~     hypothesise that CALED can improve sleep and well-being in both elderly with frailty and~     dementia.~   "
23206|NCT03263208|"~     The purpose of this study is to infusion CD19 CAR-T cells to the patients with relapsed and~     refractory CD19+ B cell leukemia, to assess the safety and feasibility of this strategy. The~     CAR enables the T cell to recognize and kill the leukemic cell through the recognition of~     CD19, a protein expressed of the surface of the leukemic cell in patients with CD19+~     leukemia.~   "
23207|NCT03263195|"~     The purpose of this study is to compare the incidence of Zika virus (ZIKV) infection among~     pregnant women with and without Human Immunodeficiency Virus (HIV) infection and to determine~     the risk of adverse maternal and child outcomes associated with ZIKV/HIV co-infection across~     clinical sites in the continental United States (U.S.), Puerto Rico (P.R.) and Brazil.~   "
23208|NCT03263182|"~     This study would like to determine if the introduction of the Safe Childbirth Checklist and~     associated mentorship can improve the adherence of skilled birth attendants (SBAs) to the~     essential practices of childbirth delivery.~   "
23209|NCT03263169|"~     A pragmatic randomized trial to evaluate the impact of an integrated patient experience and~     outcome measurement system supported by citizens, caregivers and community through eHealth~     technology.~      The primary research question is: What is the effectiveness of the WECCC approach on quality~     of life in people aged 65 and older or who self-identify as disabled compared to people not~     receiving the Health TAPESTRY program?~   "
23210|NCT03263156|"~     Sleep problems are very common in children with ADHD, with a prevalence rate as high as 73%,~     and often pose significant challenges and stress to the families. Sleep problems in ADHD~     children are strongly associated with the exacerbation of daytime symptoms, impaired physical~     health, and poor parental mental health. The present study is a randomised controlled trial~     to compare the effects of a parent-based sleep intervention for children with ADHD (aged~     6-12). Eligible participants will be randomised to either intervention (two face-to-face~     consultation sessions and one follow-up phone call) or waiting-list control condition.~     Assessments will be conducted at pre-treatment (baseline), one-week after the intervention~     (post-treatment), and 3 months after the intervention.~   "
23211|NCT03263143|"~     The study compares early palliative care consultation to standard of care in the medical~     intensive care unit (ICU). The study will assess if the intervention leads to an increased~     proportion of clearly delineated goals of care and quality of life and examine if this~     intervention leads to decreased length of days in the ICU, Hospital, and on mechanical~     ventilation.~   "
23212|NCT03263130|"~     The purpose of this cross-sectional, observational study is to evaluate the site and~     mechanism(s) for expiratory airflow limitation in chronic, treated, current or former smokers~     (>15 pack years) with COPD, Emphysema, and Asthma-COPD Overlap with mild to severe expiratory~     airflow limitation. Treatment may include short and long acting inhaled beta2agonists, short~     and long acting inhaled muscarinic receptor antagonists, inhaled and or oral corticosteroid,~     oral antibiotic, supplemental oxygen, and PDE type 4 inhibitor. In some cases, the patient~     may have had a history of asthma preceding the development of COPD (Asthma COPD Overlap).~   "
23213|NCT03263117|"~     Objectives:~      This study aims to assess if the use of general anesthesia (GA) or sedation (CS) in patients~     with acute stroke undergoing intra-arterial mechanical thrombectomy, leads to better~     neurological outcomes and less peri-procedural complications.~      Hypothesis Null Hypothesis: There are no differences in outcomes in patients with acute~     stroke treated by intra-arterial mechanical thrombectomy using General anesthesia or~     Sedation.~   "
23214|NCT03263104|"~     Coronary heart disease (CHD) is one of the major causes of death and disability in~     industrialised countries. Results from several epidemiological and clinical studies indicate~     a positive correlation between elevated total serum cholesterol levels, mainly reflecting the~     LDL-cholesterol fraction, and risk of CHD. It is thought that a reduction in total plasma~     cholesterol levels in populations suffering from primary hypercholesterolemia (elevated~     cholesterol) can lower the incidence of coronary thrombosis. Currently, therefore there is~     extensive interest in the management of serum cholesterol and other blood lipids. Diet is~     viewed as a major influencing factor that can reduce levels. This is largely driven by the~     expense of drug therapy, the large numbers of individuals affected and unwanted side effects~     of such treatments. Dietary strategies for prevention of CHD implicate adherence to a~     low-fat/low-saturated fat diet. Although such diets may present an effective approach, they~     are difficult to maintain on a long-term basis and efficacy diminishes over time. As such,~     new approaches towards identification of other dietary means of reducing blood cholesterol~     levels have been evaluated. These include, among others, the use of probiotics. Probiotics~     are 'live microbial feed supplements that offer a benefit to health'. They are marketed as~     health or functional foods whereby they are ingested for their purported positive advantages~     in the digestive tract and/or systemic areas like the liver, vagina or bloodstream. The main~     goal of the study was to test whether probiotics can directly degrade cholesterol as well as~     produce metabolites that interfere with its synthesis in the liver. The effect may also be~     partially ascribed to an enzymatic deconjugation of bile acids.~   "
23215|NCT03263091|"~     The purpose of this study is to determine whether FG-4592 is safe and effective in the~     treatment of anemia in patients with Lower Risk Myelodysplastic Syndrome and Low Red Blood~     Cell Transfusion Burden.~   "
23216|NCT03263078|"~     The purpose of this study is to compare the difference between total intravenous anesthesia~     to inhaled anesthesia in major surgery.~   "
23217|NCT03263065|"~     This study will compare 3 food products (bran, psyllium and nopal) on intestinal water~     content measured via MRI.~   "
23218|NCT03263052|"~     This study will investigate whether converting patients from FDA approved immediate-release~     tacrolimus to FDA approved extended release tacrolimus (Envarsus) reduces neurological~     side-effects, improves quality of life, and enhances adherence. A select group of elderly (>~     60 years of age) patients, who are especially sensitive to tacrolimus-related adverse (AEs)~     effects, will be provided the opportunity to convert to Envarsus with this study.~   "
23219|NCT03263039|"~     In the RESPONDER study, the role of the immune evasive mechanisms combined with genomic~     characterization will be explored in urothelial cancer patients treated with second-line~     treatment with pembrolizumab.~      Combined profiling of immune and molecular status is novel and may contribute to improved~     patient stratification and provide rationale for future treatment strategies containing~     pembrolizumab.~   "
23220|NCT03263026|"~     This randomized, placebo-controlled phase 3 study is planned to enroll approximately 235~     treatment-naïve subjects with high-risk Diffuse Large B-Cell Lymphoma (DLBCL). Subjects will~     be randomized 1:1 to R-CHOP plus enzastaurin or R CHOP (plus placebo during induction). All~     subjects will receive up to 6 cycles (3 weeks per cycle) of treatment. PET/ CT will be used~     to assess radiographic response at the end of treatment. Each subject's treatment assignment~     will be unblinded after initial phase of treatment. Subjects randomized to the enzastaurin~     arm who have a response will be offered maintenance treatment of the study drug for up to 2~     additional years.~   "
23221|NCT03263013|"~     Background:~      Functional movement disorder (FMD) causes involuntary movements, such as spasms, shaking, or~     jerks. These symptoms are not due to a recognized neurological or medical cause. Researchers~     want to better understand how the brain works to cause these symptoms.~      Objective:~      To test if intermittent theta burst stimulation (iTBS) affects brain areas involved in FMD~     symptoms. Also, to look at the effect of iTBS on mood and motor symptoms.~      Eligibility:~      Right-handed people ages 18-65 who have FMD and participated in protocol 07-N-0190~      Design:~      Participants will have 4 visits.~      In Visit 1, participants will be screened with:~      Medical history~      Physical exam~      Urine test~      Questionnaires~      Visit 1 might also include a brain MRI and functional MRI. The MRI scanner is a cylinder~     surrounded by a strong magnetic field. They will lie on a table that can slide in and out of~     the cylinder. For the functional MRI, they will be asked to perform tasks during the MRI~     scan.~      Visit 2 will be 1-2 weeks after Visit 1. Visits 2, 3, and 4 will be no more than 48 hours~     apart. These include:~      Electromyography: Small electrodes are taped to the skin. Muscle activity is recorded while~     participants receive magnetic stimulation of the brain.~      Transcranial magnetic stimulation and iTBS: A wire coil is held on the scalp. A brief~     electrical current passes through the coil and creates a magnetic pulse to stimulate the~     brain. During iTBS, participants will sit quietly and watch a nature documentary. They will~     wear earplugs and a cap.~      MRI~      Functional MRI~      Questionnaires~   "
23222|NCT03263000|"~     Background:~      Some people who have increased blinking may later develop blepharospasm. Blepharospasm is a~     neurological disorder that causes involuntary closing of the eyes. Researchers want to learn~     more about how eyes close in response to different stimuli. They want to study this in~     healthy people, people with increased blinking, and people with blepharospasm.~      Objective:~      To learn how light exposure affects people with blepharospasm.~      Eligibility:~      People ages 18 and older with blepharospasm or increased blinking, and healthy volunteers~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Neurological exam~      Participants will have up to 5 visits. The number of visits will depend on the number of~     tests they opt to have. They can opt to have up to 4 tests. Visits last 60-90 minutes. They~     cannot drink alcohol or caffeinated drinks for at least 12 hours before visits. Visits could~     include the following tests:~      Evaluation of eyelid movements. This will be video recorded.~      Electromyography: Small sticky electrodes are placed on the lower eyelid skin. These are~     attached to wires. Muscle activity is recorded during blink reflex procedures.~      Electrical stimulation: An electrode is placed close to the eyebrow. It will deliver small~     electrical shocks. The strength of the shocks will be enough to provoke a blink.~      Photic stimulation: A lamp is placed in front of the face. It will deliver single or paired~     flashes. The flashes will be at various intervals and intensities. Participants will wear a~     patch over one eye during this test.~      Combination of electrical and photic stimulation~   "
23223|NCT03262987|"~     May-Thurner syndrome is the result of compression of the left common iliac vein between the~     right common iliac artery and overlying vertebrae.~      In This Study , We will detect the role of color doppler US in the diagnosis of May-Thurner~     Syndrome in comparison to Direct CT Venography~   "
23224|NCT03262974|"~     Imatinib, the tyrosine kinase inhibitor, is used for treatment of Philadelphia positive~     chronic myeloid leukemia. Despite its efficacy and favorable pharmacokinetic profile, there~     is a large inter-individual variability in imatinib plasma concentrations, which may lead to~     treatment failure and disease progression. Polymorphisms in genes related to absorption,~     distribution, metabolism and excretion of imatinib may affect the bioavailability and~     consequently the response to the drug.~      The study aims to investigate the possible effect of genetic polymorphisms in certain~     metabolizing enzymes [CYP3A5*3 (rs776746), CYP2C8*3 (rs11572080 and rs10509681)] and membrane~     transporters [ABCB1 2677G>T/A (rs2032582) and SLC22A1 1222A > G (rs628031)] by PCR on the~     plasma level (by HPLC-UV) and molecular response (MMR) of imatinib in patients with CML.~      The study also aims to provide CML patients with a personalized treatment option, thereby~     probably improving the response and reducing the side effects.~   "
23225|NCT03262961|"~     -  Mild pre-eclampsia represents 75% of cases with pre-eclampsia, possible progression to~          severe pre-eclampsia makes mild pre-eclampsia a serious problem that requires attention.~        -  Previous studies have shown that expectant and conservative management of pre-eclampsia~          in the context of extreme prematurity may improve perinatal outcomes. Indeed, it has~          been estimated that for each additional day of pregnancy prolongation between 24 and 32~          weeks of gestation, there is a nonlinear corresponding gain of 1% in fetal survival.~        -  Sildenafil citrate has been used for increasing utero-placental perfusion in cases with~          intrauterine growth restriction, which makes it a promising drug in management of mild~          pre-eclampsia.~   "
23226|NCT03262948|"~     This is a randomized, multicenter, open, controlled phase III trial. 388 subjects with stage~     IIIB who were not eligible for radical surgery or radiotherapy, stage IV or recurrent~     squamous cell NSCLC were enrolled in this study .The subjects will be randomly assigned to~     one of the two treatment groups at a 1: 1 ratio, and stratified by sex, ECOG physical status,~     smoking status, disease staging.~   "
23227|NCT03262935|"~     The purpose of this study is to demonstrate that SYD985 [(vic-)trastuzumab duocarmazine] is~     superior to physician's choice in prolonging progression free survival.~   "
23228|NCT03262922|"~     The aim of the study is to compare the exposure to environmental and professional toxics by~     patients with systemic scleroderma and by patients not achieved by this pathology.~   "
23229|NCT03262909|"~     Multicenter, open-label, controlled, non-randomized, double arm trial with a prospective~     treatment arm (GelrinC). This study compares the efficacy and safety of GelrinC to a~     historical control arm (microfracture) in the treatment of cartilage defects in the knee.~   "
23231|NCT03262883|"~     It is known that the number of Chronic Critical İllnes, an iatrogenic condition, increases~     all over the world. The prevalence of Chronic Critical Illness in Turkey is unknown. The~     investigators aimed to evaluate the etiology, comorbid conditions, demographic data,~     prevalence, mortality and costs of these patient in intensive care units in Turkey. In this~     multi-centered study, The investigators will retrospectively review the last 1 year of~     patients receiving treatment at the Adult Intensive Care Unit.~   "
23232|NCT03262870|"~     Gut microbiota and multiple sclerosis Multiple sclerosis is a pro-inflammatory demyelinating~     disease of the central nervous system.~   "
23233|NCT03262857|"~     60 healthy patients pulpitis and requiring root canal therapy are selected. . Sampling was~     done in a simple and non-experimental way from a dental clinic in Isfahan, and then the~     samples were randomly assigned to one of the two experimental groups (A, B) using simple~     random numbers.~      Each vial is filled with distilled water or magnesium sulfate by an individual who is unaware~     of the nature of the design and is not involved in the design, and each letter A or B is~     written. This statement is not decoded after the statistical examination. Therefore, the~     study is blind and blind. In this way, 60 patients are examined in 2 groups of 30 First,~     patients with recognized pulpitis in mandibular posterior teeth have been identified and~     information about them is given. Patients will be introduced to the executive phase after the~     required explanation and clarification of the ambiguity and written consent. After completing~     the patient information form by the practitioner and complying with all entry and exit~     criteria, the study begins on each patient.~      The patient records his pain as an initial pain on the Heath-Parker Visual Analogue Scale~     (VAS). This pain measurement method involves a 180 mm line with descriptive words that~     differentiates patients on a line where the best describes their pain. In order to design a~     standard injection of the maxillary nerve block in all patients, using Aspirating Dental~     Injection Syringe, Novocol Ontario, Canada, the needle of the 27 mm long 35 mm (Septoject,~     Septodont, Saint-Maur-des- Fosses cedex, France) Lidocaine 2% with epinephrine 80000/1 mixed~     with magnesium sulfate or distilled water, injections in the retro-cell region and cm1 above~     the occlusal mandibular plan. After insertion of the needle at a rate of 3-5 mm into the~     tissue, aspiration was performed and about 2-3 ml / 2. It is injected from the contents of~     the cartridge, the syringe 1 mm is returned to the bone hard tissue (in the form of the~     syringe body in the perimmel area of the opposite side), and after the aspiration of the~     contents of each cartridge in a 1 minute period It is injected. After 15 minutes, in case of~     numbness of the lips, the patient begins to study and the access cavity begins on the desired~     tooth. In each of the stages of acquiring the access cavity or entering the initial file to~     the canal, in the event of pain, the treatment is suspended and the patient signs his pain on~     the pain assessment chart based on the Heft-parker VAS and at this stage the study It's over.~     In the absence of anesthetized lips, the patient is excluded from the study and after~     completing the injection, the root canal is given.~   "
23234|NCT03262844|"~     Background: Tethered cord syndrome (TCS) is a progressive clinical condition including a~     series of neurological dysfunctions and deformities attributable to abnormally increased~     tension on the spinal cord, which is lacking effective treatment to relieve the symptoms and~     prevent progression. Dr. Shi recently proposed a new technique as nerve root axial~     decompression surgery, which is also called capsule surgery, to treat patients with TCS. Yet,~     the effectiveness and safety should be further studied.~      Purpose: The aim of this study is to compare the effectiveness and safety of clinical~     outcomes between capsule surgery and conservative treatment in patients with TCS. A study~     hypothesis is that outcomes will be improved after capsule surgery.~      Methods: This study is a randomized clinical trial with a two-factor (2x7) research design.~     The TCS patients will be randomly assigned in one of the two treatment groups: capsule~     surgery and conservative treatment. Seven outcome measures will be collected pre-operative~     for baseline, and then at1, 12, 24, 48, and 96 weeks post-operative follow-up visits,~     including: International Consultation on Incontinence Modular Questionnaire Short Version~     (ICI-Q-SF), Rintala Score, a new developed Chinese version of questionnaire, Oswestry~     disability index (ODI), SF-12, foot function index (FFI) and Pirani score. Urodynamic~     testing, bladder ultrasonography, electromyogram, muscle strength and sensation of lower~     limbs will be obtained before and post treatment, to determine the patient`s function of~     lower limbs. The investigator performing the outcome measures will be blinded to group~     assignment, and therefore will not participate in treatment. After randomization, the~     conservative group will be followed up in the outpatient clinic. The capsule surgery group~     will receive the nerve root axial decompression surgery (capsule surgery).~      Data Analysis: Two 2x7 MANOVAs with repeated measures will be used to examine the differences~     in the seven measures between groups and at the five different time frames with the α level~     set at 0.05. Non-parametric tests (Mann-Whitney U tests) will be used to compare the~     differences in the urodynamics and muscle strength data over time and between groups.~   "
23235|NCT03262831|"~     The investigators hypothesize that a personalized yoga program with mindful movement~     implemented during breast cancer therapy will benefit women in multiple ways. The~     investigators predict that women participating in the program will experience less weight~     gain and fatigue and will have an improved quality of life compared to women not~     participating in the program. The investigators predict that this will be associated with~     decreased markers of inflammation. The investigators will also evaluate whether there is~     improved pathologic response rate compared to historical controls. This study will provide~     pilot data for a larger randomized controlled trial assessing whether program can provide~     long-term improvement in quality of life, weight maintenance, and the serum and tumor changes~     correlating with a reduced risk of recurrence and mortality.~   "
23236|NCT03262818|"~     The investigators have developed co-registered photoacoustic and ultrasound (US) imaging~     technique that allows the investigators to visualize tumor structure and functional changes~     simultaneously, which may potentially reveal early tumor angiogenesis development that is not~     available by US alone. The ability to detect early angiogenesis changes, as well as tumor~     morphology changes in the ovary, using a non-invasive imaging modality will greatly enhance~     the care for women.~   "
23237|NCT03262805|"~     The current study is designed to assess the pain relieving effect of 4-weeks ingestion of~     this commercialized dietary supplement (Lanconone®, Enovate Biolife, LLC, 1000 mg twice per~     day) in mild to moderate OA subjects. Also, the current study intends to assess the safety~     and efficacy of long term administration of Lanconone in larger sample size as compared to~     the earlier studies.15,16 The study also intends to analyse the effect on joint stiffness and~     function by means of self-reported WOMAC & Lequesne questionnaire.The effect of IP on~     clinically proven biomarker, hs-CRP will be analyzed in comparison with placebo.~   "
23238|NCT03262792|"~     This is a 12 weeks randomized, double-blind, placebo-controlled clinical study to assess the~     effect of ParActin® at low dose of 300 mg/day and high dose of 600 mg/day in the study~     population in the age range of 40-70 years and suffering from mild-moderate OA.~   "
23239|NCT03262779|"~     The investigators propose a trial to evaluate if the addition of ipilimumab to nivolumab~     after primary resistance to anti- programmed death 1 (PD-1) axis therapy can lead to~     objective radiographic tumor regression.~   "
23240|NCT03262766|"~     The purpose of this research study is to investigate the effectiveness of a combinatorial~     therapy of breathing low oxygen in short bursts-acute intermittent hypoxia (AIH) and upper~     limb training on arm strength and function, and comparing it with individual treatments in~     persons with spinal cord injuries.~      The investigators hypothesize that a combinatorial intervention with AIH therapy + upper limb~     training will be significantly more effective in improving hand function, compared to~     individual treatments alone.~      To test this hypothesis, the investigators will determine the impact of combined daily AIH~     therapy and high-repetition task-specific upper extremity training on arm strength and hand~     dexterity in persons with spinal cord injuries.~   "
23241|NCT03262753|"~     Background: Coarctation of the aorta (CoA) can be treated using surgery, balloon angioplasty~     or stent implantation. Although short-term results are excellent with all three treatment~     modalities, long term cardiovascular (CV) morbidity and mortality remain high, likely due to~     persistently abnormal vascular function. The effects of treatment modality on long term~     vascular function remain uncharacterized. The goal of this study is to assess vascular~     function in this patient population for comparison among the treatment modalities. Methods:~     Vascular function in large and small arteries will be prospectively assessed fusing multiple~     non-invasive modalities, and the results will be compared among the three groups of CoA~     patients previously treated using surgery, balloon angioplasty or stent implantation after~     frequency matching for confounding variables. A comprehensive vascular function assessment~     protocol was created to be used in 7 centers. The primary outcome is arterial stiffness~     measured by arterial tonometry. Inclusion and exclusion criteria were carefully established~     after consideration of several potential confounders. Sample size was calculated for the~     primary outcome variable. Conclusions: Treatment modalities for CoA may have distinct impact~     on large and small arterial vascular function. The results of this study will help identify~     the treatment modality that is associated with the most optimal level of vascular function,~     which, in the long term may reduce CV risk.~   "
23242|NCT03262740|"~     The purpose of this study is to investigate the effect of BMS-986195 in combination with an~     oral contraceptive in healthy female patients.~   "
23243|NCT03262727|"~     The purpose of this study is to investigate the effect of BMS-986165 in combination with an~     oral contraceptive in healthy female patients.~   "
23244|NCT03262714|"~     The goal of this randomized controlled trial is to investigate the effects of a dance~     intervention on cardiovascular risk factors and functional capacity of older women, comparing~     dancing to a walking exercise intervention and to an active control condition (stretching).~     The participants will include women between 60 and 80 years old, with body mass index~     inferior to 35 Kg /m2. The main outcome of this study is the peak oxygen consumption~     (VO2peak). The secondary outcomes are cardiovascular risk associated factors (C-reactive~     protein, TNF-alpha, lipid profile, etc) and functional performance (muscle strength and~     power, balance, gate ability, etc). The experimental design will include 3 parts: 1)~     Pre-intervention assessments: medical evaluation, fasting blood exams, maximum exercise test,~     assessments of body composition, balance, gate ability, muscular strength and power. 2)~     Period of interventions: patients will be randomized to one of the three following groups:~     dance, walking or stretching. The duration of the interventions will be 8 weeks, including 3~     sessions per week for dance and walking, and once a week for the stretching group. Each~     session will last 60 min. 3) Post-intervention assessments: the same protocols of testing as~     pre-intervention.~   "
23245|NCT03262701|"~     There have been many adjunctive treatments for the additional clinical benefits to scaling~     and root planing (SRP) in the treatment of chronic periodontitis. Topical hydrogen peroxide~     (HP) delivered in a custom fabricated tray has been shown to improve pocket depth (PD) and~     inflammation. The purpose of this study is to assess the adjunctive treatment outcome of HP~     gel in custom tray application in individuals with chronic periodontitis receiving SRP. The~     purpose of this investigator-initiated study is to evaluate and compare the clinical effects~     of scaling and root planing (SRP) combined with local delivery of 1.7% hydrogen peroxide (HP)~     gel in customized trays to that of SRP alone.~   "
23246|NCT03262688|"~     A multicenter, single-dose study in children 12 to <17 years of age, 6 to <12 years of age, 2~     to <6 years of age who are scheduled for elective open inguinal hernia repair. Enrollment in~     this study will start with the oldest age group (12 to <17 years) and will continue in a~     step-wise fashion until appropriate doses are established for all 3 pediatric age groups (12~     to <17 years, 6 to <12 years, 2 to <6 years).~   "
23247|NCT03262675|"~     NATURE-HF is an observational, multicentric and longitudinal study of heart failure performed~     with 100 tunisian cardiologists.~   "
23248|NCT03262662|"~     Varenicline is the most effective smoking cessation therapy available. Nevertheless, most~     smokers using varenicline relapse within the first few months after quitting. Varenicline is~     hypothesized to help smokers to quit in part by reducing the reinforcing effects of smoking~     during the standard 1-week pre-quitting treatment phase. Learning theory and previous human~     and animal research support the hypothesis that a longer period of varenicline treatment~     prior to the target quit date (TQD) will lead to greater reductions in smoking before~     quitting, and higher long-term cessation rates, compared to standard varenicline treatment.~     Building on promising preliminary clinical data, the study tests these hypotheses with a~     full-scale randomized clinical trial (RCT). 320 treatment-seeking smokers will be randomized~     to a standard run-in group (3 weeks of placebo, followed by the standard 1 week of pre-TQD~     varenicline) or an extended run-in group (4 weeks of pre-TQD varenicline). Both groups will~     receive brief individual cessation counseling and 11 weeks of post-TQD varenicline. The~     primary outcome measure will be bio-verified continuous abstinence at end-of-treatment (weeks~     8-11 post-quit; cessation at 26-weeks post TQD will also be examined. Hypothesized mediating~     mechanisms (e.g., smoking reinforcement) will be evaluated by behavioral, physiological, and~     subjective measures assessed both in the lab and using real-world, real-time electronic~     momentary assessments (EMA). The investigators predict that long-term, bio-verified smoking~     cessation will be improved among the extended run-in group compared to the standard run-in~     group. The investigators further predict the improved clinical outcomes with extended run-in~     varenicline will be explained (or mediated) by greater pre-quit reductions in smoking~     reinforcement among the extended run-in group compared to the standard run-in group. The~     significance of this work is clear: The project aims to make best available treatment for~     smoking cessation even better, using a method that is ripe for dissemination and an approach~     that will elucidate critical mechanisms to target in the next generation of treatment~     enhancement.~   "
23249|NCT03262649|"~     The Manitoba Inflammatory Bowel Disease (IBD) Cohort Study participants were drawn from a~     population-based research registry.~      The cohort consisted of 388 adult enrollees with recent IBD onset who completed the baseline~     survey and interview in 2002 to 2003. Participants were followed every 6 months with surveys~     and annually with interviews. Diagnosis and disease type were verified by chart review.~   "
23304|NCT03261934|"~     Chronic atrophic gastritis (CAG) is acknowledged as the precancerous stage of gastric cancer~     (GC). The present study aims to developed risk assessment and syndrome evolution models of~     CAG malignant transformation events combining TCM indicators with modern medicine indicators.~     The proposed study is a registry study based participant survey conducted in 4 hospitals in~     Beijing, China. After obtaining informed consent, a total of 2000 study patients diagnosed~     with CAG will be recruited. 10-year follow-ups are carried out on-site in hospitals and~     off-site by telephone to track malignant transformation events.~   "
23421|NCT03260413|"~     This study aims to answer the question of what is the burden of lower respiratory disease~     (pneumonia) among children ages 1 month to 5 years of age in rural Cambodia. The primary~     objective will be to quantify the prevalence of severe pneumonia at Chenla Children's~     Healthcare, a hospital in the rural town of Kratie, Cambodia. This will involve a chart~     review of the medical records available at Chenla Children's Healthcare.~   "
23250|NCT03262636|"~     Primary malignant and non-malignant brain tumors account for an estimated 21.42 cases per~     100,000 for a total count of 343,175 incident tumors based on worldwide population estimates.~     These entities result in variable but disappointing rates of survival, particularly for~     primary brain tumors (5-year survival rates: anaplastic astrocytoma 27%; glioblastoma~     multiforme 5%). Metastatic brain tumors outnumber primary brain tumors (estimates as high as~     10:1) as they affect approximately 25% of patients diagnosed with cancer. In terms of brain~     tumor surgery, the extent of surgical resection—a factor that is greatly impacted by a~     Neurosurgeon's ability to visualize these tumors—is directly associated with patient outcomes~     and survival. Although spinal cord tumors are lower in terms of their incidence, data~     correlating extent-of-resection to outcomes and survival have been demonstrated in patients~     with intramedullary tumors. Using systemically delivered compounds with a high sensitivity of~     detection by near-infrared fluorescence, it would be possible for us to improve surgical~     resection thus minimizing chances of recurrence and improving survival. The use of an ICG~     probe registered with MRSI-derived metabolic data allows for the operating field and tissue~     at the tumor/normal brain or spinal cord interface to be observed in real-time.~   "
23251|NCT03262623|"~     Background: Lateral epicondylitis, or tennis elbow, is a common musculoskeletal disorder that~     causes pain and functional limitation. Although different nonsurgical conservative therapies~     such as bracing, physical therapy, nonsteroidal anti-inflammatory drugs, and corticosteroid~     injections in addition to surgical approaches have been used, yet there is no standard~     treatment for lateral epicondylitis.~      Objectives: The primary objective of this study is to assess the effectiveness of nerve~     stimulator guided radial nerve block for treatment of lateral epicondylitis. The primary~     outcome measure is pain measured through the Visual Analogue Scale (VAS) at 1 and 2 weeks.~      Methods: This is a prospective randomized, double blind clinical trial that will be conducted~     between September 2017 and March 2018. Patients will be randomly allocated into two groups.~     Group I will receive radial nerve block guided by a nerve stimulator. Group II patients will~     receive placebo through radial nerve block. Patients will be followed up for 2 weeks.~   "
23252|NCT03262610|"~     The objective of this single patient study is to assess the safety and efficacy of~     setmelanotide as a treatment of severe metabolic abnormalities resulting from LD, especially~     refractory hypertriglyceridemia leading to recurrent bouts of pancreatitis.~   "
23253|NCT03262597|"~     The beverage hydration index (BHI) assesses the hydration potential of any consumable fluid~     relative to water. The BHI is a relatively new metric. Our purpose was to assess the BHI of~     beverages never previously tested, including an amino acid-based oral rehydration solution~     (AA-ORS), a glucose-containing ORS (G-ORS) and a sports drink (SD) compared to water~     (control).~   "
23254|NCT03262584|"~     The Sponsor hypothesize that Next-generation Sequencing (NGS) can identify fungal pathogens,~     is more accurate than other noninvasive options and can report fungal genomic load.~   "
23255|NCT03262571|"~     Purpose. The aim of this study is to evaluate whether lung ultrasound, in addition to~     physical examination, leads to a reduction of the admission rate for acute decompensated~     heart failure of patients with chronic heart failure (HF) followed in the outpatients heart~     failure clinic.~      Methods. This is a prospective randomized study. The planned sample size consists of 440~     patients with chronic HF.~      The inclusion criteria are: (1) male and female aged between 18 and 90 years (2) signed~     written informed consent (3) history of HF for at least six months, (4) left ventricular~     ejection fraction < 45%, (5) adequate medical therapy for HF for at least two months.~      The exclusion criteria are: (1) concomitant enrollment in other clinical studies, or~     treatment with experimental drugs or devices within 30 days of clinical assessment, (2)~     inability to undergo to the planned follow-up and procedures (3) documented pulmonary~     infections (3) interstitial lung disease and class 4 chronic obstructive pulmonary disease~     according to GOLD classification.~      Patients are randomized in two groups: group A, patients undergoing to lung ultrasound and~     physical examination; and group B, patients undergoing to physical examination only. Patients~     are evaluated at baseline and after three months with medical history, Quality of Life test,~     physical examination, blood sample for hematochemical (creatinine, electrolytes,~     BNP/NTpro-BNP).~      The diuretic therapy is then optimized according to the presence and severity of B-lines in~     group A and physical examination in group B.~      Only patients enrolled in group A undergo to a lung ultrasound examination to assess the~     extent of pulmonary congestion, through its evidence of B-lines. B-lines originate from the~     contrast between air-filled structures and water-thickened pulmonary interlobular septa. This~     leads to linear echogenic vertical artefacts that spread from the pleural layers downwards in~     the screen. The ultrasound examination is performed with a handheld echocardiography device.~     The physician carries out a scan of the pulmonary fields, from basal towards mid and apical~     fields, through the midaxillary line while the patient lies supine. The quantification of~     B-lines is performed according to their extent over the lung fields. All the information are~     recorded in dedicated forms.~      The results are evaluated according to the following criteria. The primary end-point is a~     significant reduction of hospitalizations for acute decompensated HF in group A during the~     follow-up period. The secondary end-points are changes of NT-proBNP values, quality of life~     test (QLT) score and cardiac mortality.~   "
23256|NCT03262558|"~     Cardiac surgery with extracorporeal circulation (ECC) yields a deep immune system dysfunction~     that exposes patients to postoperative infectious complications. Among these, post-operative~     mediastinitis with Staphylococcus aureus (SA) generates significant morbidity and mortality.~     Two radically different approaches have been proposed in recent years to reduce the incidence~     of this complication. A first approach has attempted, without real success, to decrease~     postoperative immunosuppression. The second, more efficient, consisted of screening and~     preoperatively treating patients colonized with SA. However, although its incidence has~     decreased, postoperative mediastinitis remains a terrible nosocomial infection. The authors~     believe that a thorough analysis of the immunological changes induced by cardiac surgery will~     initiate active therapeutics to reduce the post-operative immunosuppression phase, thereby~     decreasing the risk of nosocomial infections. In addition, a study of the interactions~     between the operated (host) and staphylococcus aureus (pathogenic) immune systems will~     provide a better understanding of the mechanisms that expose patients to this bacterium.~   "
23257|NCT03262545|"~     The study is to investigate the efficacy and safety of apatinib in patients with advanced~     ovarian cancer,who has received second-line chemotherapy and failed.~   "
23305|NCT03261921|"~     One of the most commonly used regional anesthetic techniques in pediatric surgeries is the~     caudal epidural block. Its main disadvantage remains the short duration of action. Hence,~     different additives have been used. Dexmedetomidine as an additive to the local anesthetic~     bupivacaine in caudal epidural analgesia prolongs the duration of postoperative analgesia so~     is dexamethasone. The investigators aimed to study the effect of combining both additives in~     the duration of analgesia, decreasing side effects and decreasing anesthetic doses~   "
23422|NCT03260400|"~     The device, a bipolar percutaneous intramuscular electromyography electrode, is intended for~     use in upper-limb amputation patients who have received the regenerative peripheral nerve~     interface surgical procedure, in order to enable the use of advanced prosthetic arms and~     hands.~   "
23258|NCT03262532|"~     Transesophageal echocardiography (TEE) is often used by anesthesiologists during cardiac~     surgery, as a monitoring tool in non-cardiac surgery, and as a point of care diagnostic tool~     in the intensive care unit (ICU). Furthermore, TEE is becoming a core skill in many~     specialties to facilitate focused cardiovascular assessment in hemodynamically compromised~     patients in various settings. Educators must determine how to best instruct current and~     future trainees to achieve clinical competence in TEE within a time limited and constantly~     expanding medical curriculum.~      In this study the investigators will evaluate a new online TEE Simulation module as a~     learning tool to accelerate and enhance traditional clinical teaching. This project will~     evaluate a new online TEE Simulation module that replicates the actions required to adjust~     TEE probe position and the ultrasound plane in relation to a 3D heart model.~      The investigators hypothesize that experience with the online TEE simulation module will~     improve the ability of trainees to independently perform TEE probe manipulations necessary to~     obtain standard TEE views. The proposed study will answer this question by measuring the~     performance of trainees in obtaining 10 of the 25 standard TEE views using the Vimedix~     mannequin-based ultrasonography simulator following an hour of review of the online TEE~     Simulation module.~      The educational benefit of the Web-based TEE simulation module, will be evaluated by 20~     novices randomly assigned to two groups, a control group of 10 subjects without exposure to~     the Web-based simulation, and an experimental group of 10 subjects with exposure to the~     Web-based simulation. Both groups will be assessed on their performance in attaining the 10~     standard TEE views with the Vimedix simulator.~   "
23259|NCT03262519|"~     Obstructive sleep apnea (OSA) is an extremely common disease with inadequately explored~     neurocognitive consequences. The investigators will study OSA patients before and after~     treatment to understand how OSA changes decision making abilities, and whether treatment can~     reverse such cognitive changes. These results could provide deeper insight into how OSA~     affects decision making either temporarily or permanently, and provide another rationale or~     motivation for treatment of OSA in adults.~   "
23260|NCT03262506|"~     There is evidence that computerized cognitive training can improve cognition in healthy older~     adults and in people at risk of developing dementia, although an effective model to implement~     the training in the daily life of people and to ensure engagement is missing. This project~     studies the adherence, engagement and progress on computerized cognitive training exercises~     that were offered by the Association of Retirees from the Telecommunications (ASASTEL) to its~     associates. One hundred subjects in three different cities (Rio de Janeiro, Belo Horizonte~     and Brasilia) received licenses to perform the exercises on line and were followed by a team~     of psychologists. We will evaluate adherence, engagement and progress on the computerized~     cognitive training exercises of those subjects.~   "
23261|NCT03262493|"~     Enteral nutritional therapy, fed through the gastrointestinal tract via a catheter, tube,~     catheter, or stoma, delivers the nutrients distally to the oral cavity and may reduce~     intrahospital malnutrition. Enteral probes are inserted, at the bedside, through the nose or~     mouth into the stomach or duodenum. Among the main complications of the use enteral probes,~     we can mention: displacement of the probe and administration of diet in the respiratory tract~     or microaspirations. To prevent displacement, enteral probes are attached to the skin on the~     nose or forehead by the use of micropore-type adhesive. In the probe the adhesive tape is put~     in the form of tie and again fixed to the nose of the patient. The enteral probes~     displacement rates with this technique are around 62%; in addition, the adhesive tape can~     cause discomfort, nasal necrosis, skin lesions and skin sensitivity reactions to the patient.~     More recently the nasal bridle, an anchor of the enteral feeding tube located around the~     nasal septum or nasal septum, has been described as more effective in securing enteral probes~     position over traditional tape attachment, but is not available in our environment. In~     Brazil, the feeding tube attachment device (FTAD) is available. Until now, the performance of~     FTAD in relation to enteral probe safety and accidental exit rates has not been described in~     the literature. Material's FTAD is composed of a layer of hydrocolloid that is adhered to the~     skin on the back of the nose and a polyurethane clamp that secures the enteral probe. Thus,~     there was a need to evaluate the actual success in using the traditional mode of probe~     attachment. It should be noted that very little scientific evidence is available in the~     literature on such care, and this is due to the lack of well-designed studies on the subject.~   "
23262|NCT03262480|"~     Although fluid therapy is of paramount value in anesthetic practice, there is no guideline~     available for perioperative fluid management in major abdominal surgery. So, there is a need~     to establish whether goal directed fluid therapy protocol is effective during radical~     cystectomy and urinary diversion. A balance of perioperative fluid therapy is crucial, yet~     the method to achieve this equilibrium remains a highly debated subject. Therefore, this~     study will be designed to investigate the effects of two individualized goal directed fluid~     therapy during radical cystectomy to encourage an effective circulating blood volume and~     pressure. Accordingly, as a primary outcome, the investigators assume that stroke volume~     optimization could maintain better perioperative hemodynamic stability with low incidence and~     severity of hypotensive episodes together with achievement of maximal oxygenation. Hopefully~     this regimen could help to decrease the possibility of perioperative tissue hypoperfusion and~     the possible associated complications as a secondary outcome.~   "
23282|NCT03262220|"~     Total body irradiation (TBI) is a standard part of the conditioning regimen for bone marrow~     transplantation (BMT). Several randomized trials have shown superior outcomes using TBI~     compared with non TBI-containing regimens. Standard TBI is usually delivered over three days~     for a total dose of 12 Gy with two daily fractions. However, as demonstrated by our group,~     increasing the TBI dose above 10 Gy is not necessarily associated with better outcome in~     patients undergoing allogenic BMT for hematologic malignancies. For this reason, patients~     older than 40 or grafted after relapse are treated at our center with a reduced-dose 10 Gy~     TBI regimen. This pilot study wishes to investigate in 10 patients with hematological~     malignancies unfit for a standard 12 Gy TBI conditioning regimen a more targeted, conformal~     form of treatment, referred as total marrow (TMI), using volumetric Arc Therapy (VMAT). Our~     hypothesis is that using this technique that can allow deliver a higher total dose to the~     target while at the same time assuring to the organs at risk (OAR) the same dose normally~     delivered with a 10 Gy TBI we will improve the therapeutic ratio in these patients.~   "
23263|NCT03262467|"~     In patients with chronic renal failure, a well-functioning vascular access is essential for~     hemodialysis treatment. Native arteriovenous fistula (AVF) is the first-choice of vascular~     access, due to a lower incidence of complications and better long-term patency as compared to~     prosthetic arteriovenous fistula. With the incidence ranging between 6-60%, AVF aneurysm~     (AAVF) is a common complication of native AVF. According to Kidney Disease Outcomes Quality~     Initiative (K/DOQI) guidelines, asymptomatic aneurysms are indicated for conservative~     treatment, but precise recommendations when and how to intervene in available guidelines are~     missing.~      Several surgical (remodeling, resection and substitution, ligation) and endovascular~     techniques have been described in the AAVF treatment, but there is currently no prospective~     randomized study comparing these techniques.~      In 2008, our team published the first experience with a new surgical method of AAVF treatment~     - aneurysmorrhaphy with external porous prosthesis (Provena©, BBraun). This therapy was~     validated in several studies and has shown a good long-term patency and a minimal incidence~     of complications.~      AAVF aneurysmorrhaphy can be performed with or without an external porous prosthesis~     (Provena©, BBraun). The use of external prostheses reduces venous wall shear stress,~     turbulent flow, endothelial damage, and thrombus formation, which should improve vascular~     patency and reduce the risk of AVF re-aneurysm. So far, there is no prospective randomized~     study comparing the effect of external porous prosthesis on AVF patency and the incidence of~     postoperative complications.~   "
23264|NCT03262454|"~     The investigators hypothesized that local radiation therapy can enhance the effect of~     anti-PD-L1 monoclonal antibody through priming T-cell effector function against cancer cells.~     Described as above, The investigators concluded that modest dose of radiation to local site~     prior to immunotherapy is the best to enhance T-cell-mediated immunity. Accordingly, The~     investigators will investigate the combining effect of hypofractionated-sublethal dose of~     radiation therapy followed by anti-PD-L1 monoclonal antibody, atezolizumab, for SCLC patients~     who are recurrent or refractory for initial platinum-based chemotherapy~   "
23265|NCT03262441|"~     This is an open label, randomized Phase II study to determine whether Mycophenolate mofetil~     (MMF) given over 22 months meaningfully decreases the size of participants' HIV reservoir.~      In addition to primary safety endpoints, the following hypotheses regarding drug efficacy~     will be tested:~        1. MMF will be well tolerated and will not decrease adherence to or antiviral efficacy of~          ART.~        2. Peripheral CD4+ T-cell counts and percentages will not meaningfully decrease during~          treatment with MMF and ART.~        3. There will be no excess risk of opportunistic infections in MMF-treated study~          participants.~        4. MMF therapy will lead to a progressive decrease in reservoir size over 22 months of~          treatment.~        5. MMF therapy will lead to a continual shift in HIV reservoir composition from primarily~          effector memory CD4+ T cells (TEM) and central memory CD4+ T cells (TCM), to primarily~          stem cell like memory (TSCM) and naïve (TN) CD4+ T cells.~        6. MMF will eliminate detectable measures of the HIV reservoir, including by~          cell-associated DNA/mRNA and quantitative viral outgrowth.~        7. MMF will not decrease the humoral immune response to routine annual influenza~          vaccination.~   "
23266|NCT03262428|"~     The management of chronic conditions is a challenge for health systems worldwide,~     particularly in the context of an aging population, and requires urgent improvement of health~     services. Integrated care and patient empowerment represent promising solutions: offering~     tailored self-management support in a collaborative framework led to good results in several~     clinical contexts. Yet, large scale implementation remains a challenge. An important~     limitation of existing solutions is a lack of utilization of behavioural and communication~     theory for identifying the dynamics of pluridisciplinary collaboration and the interactive~     effects of the activities performed by several actors involved in self-management support in~     a given chronic condition. A second limitation is not involving all relevant actors in the~     development of health service improvement solutions, which leads to limited programme~     adoption and sustainability in routine care.~      This study is part of a project that proposes to address these limitations and develop and~     interdisciplinary model of collaborative care in the self-management of chronic conditions~     (CoSMaS) that adopts a community-based participative approach. CoSMaS-ql is a qualitative~     study that will consist of semi-structured interviews with several types of stakeholders:~     patients, caregivers, and health care professionals of different specialties (e.g. general~     practitioners, nurses, specialist consultants, pharmacists). The main objective of the study~     is to explore the experiences and of patients, caregivers, and HCPs on how self-management~     support is currently delivered in asthma, cancer and stroke (content, communication,~     organisation of care), their needs related to self-management support provision, and~     envisaged solutions for improving current practice. Three different chronic conditions will~     be targeted: asthma, breast cancer and stroke. The qualitative data will be analysed via~     grounded-theory and template analysis. It will inform the development of a theoretical model~     of collaborative self-management support in chronic conditions. It will also result in three~     profiles describing 'real' versus 'ideal' care processes, which will represent needs~     assessment stages for future health services improvement interventions in the three~     conditions.~   "
23267|NCT03262415|"~     The purpose of this study is to evaluate the accuracy and efficacy of the Cambridge Medical~     Technologies, LLC LabPatch Continuous Glucose Monitoring (CGM) System compared to a~     laboratory glucose analyzer (YSI 2300 STAT Plus) and 2 commercial glucometers, OneTouch Verio~     and Freestyle Lite.~      The LabPatch system includes:~        1. The LabPatch circuit chip which lies in the center of a circular push-button. The~          circuit is in the form of a small chip (approximately 15.7 mm [0.618] x 15.7 mm~          [0.618]) placed in contact with the skin. The chip has a telescopic micropipette which~          draws interstitial fluid to be analyzed for glucose levels. The chip is also able to~          measure skin temperature to ensure appropriate skin contact.~        2. A Lab Patch holding device (blue box).~        3. A wire that connects the chip to a laptop that continuously captures glucose data.~   "
23268|NCT03262402|"~     Periodontal diseases, such as chronic periodontitis (CP), frequently occur in~     immunosuppressed patients, including HIV-infected patients. The immunosuppression resulted by~     the HIV infection can justify the high frequency and the difficult in controlling the CP in~     this group of patients, raising the possibility of additional factors associated to the~     development of CP in HIV patients. The aim of this study is to determine factors that can be~     involved in the CP pathogenesis in HIV patients, including Candida spp presence, and~     biomarkers involved on the inflammatory response against the microorganisms.~   "
23269|NCT03262389|"~     Investigators are doing this study to determine which of four imaging techniques:~     Fludeoxyglucose Positron Emission Tomography (18 FDG PET) computerized tomography (CT), 18~     FDG PET Magnetic resonance imaging (MRI), C-11 acetate PET CT, and C-11 acetate PET MRI) is~     the best test for finding sites of active myeloma disease.~   "
23270|NCT03262376|"~     The objective of this acute intervention study is to examine the potential of minerals~     combined with botanicals to demonstrate unique and synergistic effects on oscillatory brain~     activity, cognitive performance, and stress reduction (endocrine, sympathetic, and subjective~     parameters) under conditions of acute stress in moderately stressed individuals~   "
23271|NCT03262363|"~     The increase in the prevalence of diabetes mellitus (DM) is one of the greatest public health~     challenges worldwide. Epidemiological studies have shown that DM is the leading cause of~     chronic kidney disease (CKD) in patients initiating renal replacement therapy. In our~     country, diabetes accounts for about 60% of all incidents of dialysis. On the other hand, CKD~     is currently considered a noxious disease because patients not only have the likelihood of~     progression to end-stage renal disease (ESRD), but because these renal alterations are~     associated with an increased risk of cardiovascular complications and premature death for the~     same cause. Most studies have focused on traditional risk factors (poor diet, physical~     inactivity and obesity) for the development and progression of renal damage, and less~     information exists on non-traditional factors such as oxidative stress and mainly, the low~     antioxidant response that characterizes both DM and nephropathy. In addition, there is a~     great variation in the susceptibility to and progression of kidney disease between different~     populations that is not explained by the presence of traditional factors and that could be~     triggered by genetic variations and its interaction with other components related to the~     environment and lifestyle. Fortunately, there is sufficient scientific evidence that early~     detection and modification of negative lifestyle factors can not only delay or halt the~     progression of the renal function decline to ESRD but can also significantly reduce the~     incidence of cardiovascular disease leading to premature death in most of these patients.~     Therefore, it is suggested that this risk may be determined by the interaction of lifestyle~     factors with the presence of susceptibility alleles, which may vary from one population to~     another. It is now known that hyperglycemia causes a state of oxidative stress and~     inflammation that can be counteracted by diet supplementation with some natural antioxidants~     such as curcumin. It has been shown that this molecule has multiple pharmacological~     properties: antioxidant, anti-inflammatory, cardioprotective, renoprotective, among others.~     In clinical trials a positive effect of curcumin has been seen in the treatment of diabetes~     and its complications. This has generated a relative optimism in the search for new curcumin~     treatment targets where oxidative stress is of great relevance, as is the case with CKD.~     However, there are still doubts about its efficacy as an adjuvant in the prevention of CKD.~     Additionally, the role played by interindividual variability in genes involved in the~     mechanism of action of curcumin is still incipient, more studies in this knowledge area are~     necessary.~   "
23272|NCT03262350|"~     The purpose of this study is to assess the effects of a regular yoga practice on body image~     in college women.~   "
23273|NCT03262337|"~     New mobile Health (mHealth) technology creates an opportunity to approach travel medicine~     research in a different way, revolutionising our understanding of risks to travellers. Using~     mHealth technology, the Epidemiology, Biostatistics and Prevention Institute (EBPI),~     University of Zurich (UZH), developed a TRAVEL app in collaboration with the Eidgnössische~     Technische Hochschule (ETH) Zurich.~      By using this new technology, an extensive collection of data (prospective collection of~     individual travel behaviour and experienced health events, mapping the travel itinerary via~     global positioning system (GPS), linking to publicly available local weather data and data on~     disease endemicity) can be combined and an unprecedented abundance of information on travel~     behaviour and experienced risks can be obtained. These data will allow a much better~     understanding of travel risk profiles using cluster analysis. By simultaneously recording~     health outcomes, the relationship between travel risk profiles and health events can be~     assessed. In this study, the investigators will address several major shortcomings in travel~     health in tropical and subtropical destinations by improving the understanding of poorly~     assessed and potentially underestimated health threats (e.g. risk of accidents and injury,~     mental health disorders), and travel risks specific to elderly travellers and travellers with~     chronic conditions. These findings will directly feed back into individual travel advice~     given by practitioners in Switzerland and finally world-wide.~   "
23274|NCT03262324|"~     There have previously been no validated a specific foot and ankle patient-reported outcome~     measures in Turkish. The Visual Analogue Scale Foot and Ankle (VAS-FA) will translated and~     adapted into Turkish language. Thereafter, 200 patients who had foot and ankle disorders or~     surgery will complete VAS-FA questionnaire set on two separate occasions. Analyses included~     testing of ﬂoor-ceiling effect, internal consistency, reproducibility, and validity.~   "
23275|NCT03262311|"~     The purpose of this study is to test the potential of a relatively simple serum assay that~     aims to identify patient subpopulations whose curative radiotherapy outcome is likely to be~     compromised by radiobiological tumour hypoxia (prognostic value) and who are most likely to~     gain (predictive value) from the addition of radiation sensitiser drugs or targeted~     radiotherapy dose escalation.~   "
23276|NCT03262298|"~     The study will evaluate safety and efficacy of the CD22-targeted chimeric antigen receptor~     modified-T cell(CAR-T) cells in the treatment of B-cell Malignancies.~   "
23277|NCT03262285|"~     the investigators will compare between the endothelial cell loss after phacoemulsification~     and extracapsular cataract extraction in management of senile cataract~   "
23278|NCT03262272|"~     Prospective multicenter randomized cross-over study Number of patients : 32 (8 patients per~     group) Obtain objectives data to advise each hemodialyzer according to dialysis treatment and~     patient profile.~      To evaluate the different hemodialyzers and judge their extraction performances in HD and~     post HDF.~      Evaluation of the biocompatibility of the hemodialyzers and the patients' inflammatory~     status.~   "
23279|NCT03262259|"~     This study will evaluate effects of a multi-component, population-level intervention on~     alcohol use and related harms in six intervention cities relative to six matched comparison~     cities. Intervention components include screening and brief interventions by health~     providers, other evidence-based interventions (e.g., enforcement of drink-driving or underage~     drinking laws), and novel or partially tested interventions that warrant further evaluation.~     Key outcomes of interest include alcohol-related harms such as alcohol-related motor vehicle~     crashes and fatalities, heavy/binge drinking, underage drinking, and drinking and driving.~   "
23280|NCT03262246|"~     The cerebral amyloïd angiopathy ( AAC) is a disease characterized by deposits of beta-amyloid~     peptids in the walls of the arteries of young and average calibre of the brain and the~     leptomeninx. The incidence of the AAC increases strongly with the age and represents a major~     cause of spontaneous brain haemorrhage to people over 60. The main demonstration is the lobar~     brain haemorrhage, the other ones are bleedings under arachnoid cortical and microbleedings~     leading to cognitive decline.~      Anatomical studies reported the presence of cortical infarcts in patients having amyloïd~     deposits suggesting an association between asymptomatic cortical cerebral infarcts and AAC.~      However prevalence and meaning of these infarcts in patients having an AAC remain badly known~     because of studies on low number of patients and the rarity of radiological analyses of these~     infarcts .A better knowledge of these asymptomatic cortical infarcts would allow to dread~     better cognitive disorders(confusions) presented by these patients, and to develop preventive~     strategies.~      Besides, the risk factors of severity of the AAC are little studied.~   "
23281|NCT03262233|"~     The objective of the current study is to evaluate the validity of the No Shock, Predictable~     Shock, Unpredictable Shock (NPU) stressor task for use as a surrogate endpoint to predict~     short-term clinical outcomes among smokers during a smoking cessation attempt.~   "
23283|NCT03262207|"~     Recent data suggest that sperm cells carry an epigenetic message during spermatogenesis and~     that this message is crucial for the future development of the embryo. This epigenetic~     signature is notably represented by methylation of genes subjected to imprinting (GSI) and~     the methylation of transposable elements (TE). Data on the maintenance of the imprint and of~     the control of TE accompanying human gametogenesis in a context of adult germinal testicular~     cancers, seminomas, are extremely fragmentary for tumour tissues and inexistent for gametes.~      The aim of this study is to determine whether patients with seminomas in comparison with~     fertile men carry a higher risk of presenting epigenetic alterations affecting their gametes.~      This study is based on the use of an existing collection of biological samples. 90 samples~     will be selected and split into 3 groups:~        -  Group 1: 30 sperm samples from patients with seminomatous testicular tumours~        -  Group 2: 30 sperm samples from fertile patients~        -  Group 3: 30 sperm samples from infertile patients~      After treatment of the samples (thawing, cell sorting and removal of cryoprotectants), they~     will be analysed.~   "
23284|NCT03262194|"~     Human cytomegalovirus (CMV) is the leading cause of neonatal viral infection and can have a~     significant impact on the neurosensory development of newborns and especially premature~     infants. CMV infection can result from materno-fetal transmission during pregnancy~     (congenital infection) or postnatal transmission. The prevalence of congenital CMV infection~     in the newborn is estimated to be between 0.1 and 0.5%. Among the newborns in utero infected~     by CMV, it is estimated that 10-15% will present symptoms at birth (hypoacousia / unilateral~     or bilateral deafness, microcephaly, chorioretinitis, psychomotor retardation, etc.) and 0.5%~     of them will die. 20% of infected infants, mainly symptomatic newborns, suffer permanent~     sequelae, mainly loss of hearing. Many asymptomatic children at birth will present hearing~     loss and other delayed neurological complications. A progressive neurosensory hearing loss~     may develop for 13-15% of asymptomatic newborns at birth. Deafness is bilateral in 50% of~     cases, severe in more than 50% of cases, and its occurrence is often delayed. The hearing~     loss has a significant impact on the future life of the child, mainly on language acquisition~     and school performance.~      A systematic CMV screening is not currently recommended at birth due to the frequency of~     asymptomatic forms, difficulty in fetal diagnosis and prognosis, lack of consensus for~     preventive and curative treatment of the infection. New treatments are being evaluated and~     encouraging results could revive the debate.~      PCR from urine is the gold standard for the diagnosis of CMV infection. Urine collection is~     not systematic in newborns and its realization can sometimes be difficult. On the other hand,~     in children at risk (hypotrophy, prematurity, infectious risks, fetal distress or respiratory~     distress at birth), gastric aspiration is systematically performed at birth to overcome~     obstruction of the upper aero-digestive tract, to prevent oesophageal atresia, to avoid~     inhalation by reflux and sometimes to make a bacteriological diagnosis.~      Our hypothesis is that this liquid could be used for the detection of CMV infection without~     adding any invasive action in newborns. Ultimately, gastric aspirate could allow for routine~     CMV screening in children at risk and thus allow for appropriate care by nursing staff.The~     occurrence of immediate or delayed sensory sequelae in these children would be then limited.~   "
23285|NCT03262181|"~     The purpose of this study is to determine differences in lower extremity landing biomechanics~     and real-world physical activity between individuals with patellar tendinopathy compared to~     individuals without patellar tendinopathy,and to determine the acute effects of an isometric~     loading intervention on lower extremity landing biomechanics in individuals with patellar~     tendinopathy.~   "
23286|NCT03262168|"~     This study will evaluate if the introduction of a supported exercise programme can improve~     physical and psychological well-being for adults with congenital heart disease.~   "
23287|NCT03262155|"~     Study of immunosuppression biomarkers in patients with ARDS or cardiogenic shock with ECMO /~     ECLS, compared to patients with ARDS or cardiogenic shock without ECMO / ECLS~   "
23288|NCT03262142|"~     This is a prospective, randomized multi-center trial investigating the impact of lower airway~     infection with P. aeruginosa in COPD patients. The aim of the study is to evaluate if~     targeted antibiotic therapy against P. aeruginosa can improve the prognosis in patients with~     COPD.~   "
23289|NCT03262129|"~     Type 1 - Multiple Endocrine Neoplasia syndrome (MEN1,) is an autosomal dominant disorder~     secondary to MEN1 mutations that predisposes carriers to endocrine tumors. The MEN1 gene~     located on chromosome 11q13 encodes menin, a 610 amino acid protein expressed in all tissues~     tested. Menin is a scaffold protein which interacts with a large number of intracellular~     molecules. MEN1 disease may display various clinical associations The tumors mainly develop~     from endocrine tissues and may arise from parathyroid glands, duodeno-pancreas, pituitary~     gland, adrenal glands, and at a lower frequency from the bronchi and thymus. The penetrance~     is very progressive but ultimately high during a lifespan.~      Although the syndrome was discovered in 1903 by Erdheim and properly documented in 1954 by~     Wermer, it was only in the 1970s that the variety of clinical presentations was acknowledged~     and first attempts to codify treatments were made. Most published studies deals with selected~     and small size populations. Thus, many aspects of the natural history of MEN1 remains unknown~     as well as the optimal care of patients. In addition, although advances in genetics improved~     the diagnosis of MEN1, there are still clinical forms whose attachment to the syndrome is~     difficult: atypical, paucisymptomatic, forms the negative genetic diagnosis (10%). These~     clinical forms need to be clarified to ensure optimum support.~      This cohort relies on the Groupe d'étude des Tumeurs Endocrines (GTE) network for MEN1,~     created in February 1991, and brings together clinical centers in France and Belgium (n=80)~     as well as the four genetics laboratories in charge of MEN1 diagnosis. It aims at improving~     the knowledge of the MEN1mainly in describing:~        -  its evolution over time globally and according to the initial presentation, (~          particularly accounting the risk of the occurrence of secondary MEN1 related or~          unrelated tumors, and death)~        -  the genotype-phenotype correlations and heritability of the disease~        -  the real life management of patients and its impact on cure and survival for each type~          of MEN1-related tumor~        -  the impact of the NEM on the patients' daily lives, their perception of the disease and~          their satisfaction with their care~   "
23290|NCT03262116|"~     Subjects will participate in three weeks of the bionic pancreas in the insulin-only~     configuration. Each week, subjects will use a different rapid acting insulin analog --~     Humalog, Novolog, or BioChaperone lispro -- in a randomized cross-over order.~   "
23291|NCT03262103|"~     The purpose of this study is to test an approach of stimulating the body's immune system to~     attack prostate cancer. This study will test injection of a substance polylysine and~     carboxymethylcellulose (Poly-ICLC, Hiltonol®)through a needle guided by MRI (magnetic~     resonance imaging) ultrasound fusion technology into the prostate gland. Poly ICLC has been~     used to help the body in its fight against cancer. The first aim of the study is to determine~     the highest dose of a substance Poly-ICLC (Hiltonol®) that can be safely tolerated by the~     study participants. The second aim of the study is to find out the toxicity or side effects~     of poly-ICLC.~   "
23292|NCT03262090|"~     Emergence agitation/delirium (EA/ED) is a common complication in pediatric surgery patients,~     which increases the risk of developing postoperative airway obstruction and respiratory~     depression. In infants, there is a high incidence of emergence agitation (EA) after~     desoflurane anesthesia. The aim of the present preliminary study was to determine the safety~     and efficacy of of intraoperative infusion of dexmedetomidine (DEX) that would prevent~     postoperative EA and ED in children undergoing day surgery with desoflurane anesthesia~   "
23303|NCT03261947|"~     The purpose of this study is to confirm the safety and tolerability of TAK-931 in a cohort of~     Western participants with metastatic solid tumors and to evaluate the anti-tumor activity of~     TAK-931 in participants with metastatic pancreatic cancer and colorectal cancer (CRC).~   "
23293|NCT03262077|"~     Due to the phenomenon of bacterial resistance, photodynamic therapy (PDT) has been studied as~     an alternative to the use of antibiotics on the periodontal treatment. However, the studies~     show several discrepancies between the parameters adopted for PDT, which makes it difficult~     to compare the results and measure their efficacy. The objective of this research was to~     investigate the tissue dosimetric parameters used in PDT for the treatment of periodontal~     disease. In order to achieve this objective, the scattering pattern of light in periodontal~     tissue, the concentration of methylene blue in the periodontal pockets and the number of~     viable microorganisms were evaluated. This clinical trial included 30 patients with chronic~     periodontitis according to the eligibility criteria. The patients were in periodontal~     treatment at the Dental Clinic at the University of Nove de Julho, where the research was~     carried out. Three incisors from each patient were selected for the experimental procedures.~     The pattern of light scattering was observed through intraoral photographs. A laser with~     emission of radiation with wavelength of 660 nm and 100 mW of power was used. The~     concentration of the photosensitizer (PS) in the periodontal pockets was evaluated by~     spectrometer before irradiation. Methylene blue was used as PS at the concentration of 100 μM~     in two different formulation and vehicles to evaluate the drug dimerization. Then, the~     procedures of irradiation of the PDT were carried out, with 3 irradiation times of 1, 3 and 5~     min. The microbiological evaluation was performed from subgengival biofilms of the~     periodontal pockets of the experimental sites, before and immediately after the irradiation~     procedures.~   "
23294|NCT03262064|"~     Bronchiectasis is defined as abnormal chronic dilatation of one or more bronchi. Patients~     have a structural abnormality of the bronchial wall that predisposes them to bacterial~     infection likely due to impaired mucus clearance. A vicious cycle of chest infections and~     chronic lung inflammation can lead to further damage of the bronchial wall and spread of~     disease to normal areas of bystander lung.~   "
23295|NCT03262051|"~     Cytochromes P450, main enzymes of drug metabolism, play a prominent role in the first-pass~     metabolism of oral substances. Inter-individual variability in their activity due to genetic~     and environmental factors has been observed and may be associated with adverse therapeutic~     outcomes (ineffectiveness or toxicity). The inflammation, whether acute or chronic, can~     theoretically modulate the pharmacokinetics of drugs by modulating enzyme activity. Indeed,~     in vitro data and animal models, as well as more limited data in humans, indicate a~     down-regulation of CYP in the context of inflammation.~      The cocktail approach developed and validated in Geneva (Geneva Cocktail) measures the~     activity of several CYP simultaneously using micro-doses of probe drugs and facilitating~     sampling (10uL capillary blood) on a dried blood spot.~      Investigators intend to measure the activity of CYP in an acute inflammation model (hip~     surgery) and chronic inflammation model (rheumatoid arthritis, RA). The effect of the~     biological agent tocilizumab (anti IL-6 receptor) in a treated patient subgroup (patients~     treated regardless of our study) will be measured after 3 months of treatment.~      The main objective is to determine if interleukin-6 levels are correlated with the activity~     of CYP450 in patients with acute (orthopedic surgery - hip) or chronic inflammation (RA).~      Secondary objectives are:~        -  To correlate CYPs activities with the levels of other inflammatory markers (CRP, TNF-α);~        -  To assess correlation between markers of inflammation, CYP activities and the intensity~          of fatigue and pain;~        -  To assess if tocilizumab reverse CYP activity in patients with RA after 3 months~          treatment.~   "
23296|NCT03262038|"~     This is a prospective randomized, double-blind, placebo-controlled study to compare the~     incidence and intensity of ITM-induced pruritus and nausea/vomiting using pre-emptive IV~     ondansetron, followed by scheduled Around The Clock (ATC) ondansetron vs. our control group,~     where pruritus and PONV are treated with PRN only medications.~   "
23297|NCT03262025|"~     Background: The importance of cecal pathologies lie in the fact that being the first part of~     large intestine, any disease involving the cecum affects overall functioning of the large~     bowel. Primary cecal pathologies presenting as acute abdomen have not been described in any~     previous study in terms of presentation, management and outcome.~      Objectives: The objective of this study was to identify the reported causes of primary cecal~     pathologies presenting as acute abdomen and the various causes presenting in Indian setting,~     to discuss morbidity and mortality associated with cecal pathologies and to critically~     analyse the various management modalities employed in emergency setting.~   "
23298|NCT03262012|"~     A Randomized, Double-Blind, Parallel Group, 28-Week Chronic Dosing, Multi-Center Long-term~     Extension Study to Assess the Safety and Efficacy in Japanese Subjects with Moderate to Very~     Severe Chronic Obstructive Pulmonary Disease (COPD) compared with Symbicort® Turbohaler®~   "
23299|NCT03261999|"~     The study will evaluate if Leuprolide Mesylate is safe and effective in the treatment of~     subjects with prostate cancer, when administered as two injections twelve weeks apart.~   "
23300|NCT03261986|"~     The objective of this study is to use radiostereometric analysis (RSA) and clinical outcome~     measures to evaluate early post-operative implant stability and the clinical performance of~     Stryker's Trident II Acetabular Cup.~   "
23301|NCT03261973|"~     Catheter ablation with pulmonary vein (PV) isolation is a commonly performed strategy~     employed for the treatment of atrial fibrillation (AF). However, ablation in the posterior~     wall of the left atrium can cause thermal injury to the esophagus. Thermal injury is very~     common and occurs in up to 40% of AF ablations per some studies. When significant thermal~     injury to the esophagus occurs, two significant complications can arise: 1) the formation of~     an atrio-esophageal fistula, and 2) gastrointestinal dysmotility. While the occurrence of~     fistula is rare, it is a very important complication since it is often fatal. Currently~     luminal esophageal temperature monitoring is the most commonly employed modality to prevent~     such injury. However, there are limitations to its use, and atrio-esophageal fistulas~     continue to be a major problem in AF ablation even when using esophageal temperature~     monitoring. Esophageal deviation using either a Transesophageal echocardiogram (TEE) or~     Esophagogastroduodenoscopy (EGD) probe has been described in the literature, but the~     effectiveness and practicality of these techniques are suboptimal, and have therefore~     precluded their use in routine clinical practice. Recently, esophageal deviation using~     off-the-shelf equipment (a soft thoracic tube and endotracheal stylet) was tested in the~     randomized double-blind multicenter study Deviating the Esophagus in Atrial Fibrillation~     Ablation (DEVIATE-AF). In that study the standard practice (i.e., use of luminal esophageal~     temperature monitoring) was compared to esophageal deviation using off-the-shelf equipment.~     The results were very encouraging showing that esophageal deviation allowed for significant~     reductions in esophageal temperature and proportion of premature ablation terminations.~     Importantly, esophageal deviation allowed the isolation all PVs in the treatment group, which~     was not the case in the control group. One major limitation in the DEVIATE-AF trial was that~     off-the-shelf equipment tool was challenging to use. The aim of the Esophageal Deviation in~     Atrial Fibrillation Ablation study is to test the feasibility and safety of moving the~     esophagus using a specialized esophageal deviation tool (DV8, Manual Surgical Sciences,~     Minneapolis, MN).~   "
23302|NCT03261960|"~     The objective of this study is to compare the safety and efficacy of BLI4700 bowel~     preparation to an FDA-approved bowel preparation as 2-day, split-dose bowel preparations~     prior to colonoscopy in adult patients.~   "
23306|NCT03261908|"~     Adverse reactions of simvastatin are mostly slight and transient, however, the incidence of~     simvastatin-induced hepatic impairment and myopathy are obviously higher in Chinese~     population than other racial groups. There is still lack of research data in Chinese. In this~     study, we will investigate whether there are specific genotypes which may predict the~     incidence of simvastatin-induced hepatic impairment and myopathy in Chinese so as to provide~     a basis for developing guidelines on precise medication in simvastatin therapy apply to~     Chinese population.~   "
23307|NCT03261895|"~     This randomized controlled trial aims to investigate the effectiveness of an integrative~     medicine (traditional Chinese medicine and western medicine) based structured education~     programme for newly diagnosed type 2 diabetes patients. The theoretical frame of this study~     is based on the health belief model and self efficacy theory. The hypotheses of this study~     are: 1) Participants in the intervention group will have higher level of self-management~     behaviour after intervention compared to participants in the control group; 2) Participants~     in the intervention group will have better diabetes knowledge after intervention compared to~     participants in the control group; 3) Participants in the intervention group will have higher~     level of self-efficacy after intervention compared to participants in the control group; 4)~     Participants in the intervention group will be less depressed after intervention compared to~     participants in the control group; 5) Participants in the intervention group will have better~     QOL after intervention compared to participants in the control group; 6) Participants in the~     intervention group will gain greater reduction in HbA1c after intervention compared to~     participants in the control group; 7) Participants in the intervention group will gain~     greater reduction in fasting blood glucose after intervention compared to participants in the~     control group; 8) Participants in the intervention group will gain greater reduction in BP~     after intervention compared to participants in the control group; 9) Participants in the~     intervention group will gain greater reduction in BMI after intervention compared to~     participants in the control group.~   "
23308|NCT03261882|"~     Although research indicates foreign-born Mexican-Americans possess a healthy weight advantage~     relative to U.S.-born Mexican-Americans, patterns are less clear for children and may be~     changing over time. The objective of this study was to examine whether the relationship~     between nativity and overweight/obesity has changed over time among Mexican-American children~     and to investigate the implications of this pattern on overweight/obesity disparities~     relative to non-Hispanic Whites. Using cross-sectional data from Mexican-Americans and~     non-Hispanic white children ages 4-17 years participating in the National Health and~     Nutrition Examination Surveys (1988-1994 (N=4,718) and 2005-2014 (N=7,269), the investigators~     used log-binomial regression to calculate prevalence ratios (PR) of overweight/obesity by~     nativity status adjusting for age, sex, householder marital status, householder education,~     survey period and a nativity by survey period interaction. The investigators also tested~     another covariate-adjusted model with a 3-level ethnicity-nativity variable that included~     Whites and an ethnicity-nativity by survey period interaction.~   "
23309|NCT03261869|"~     this study evaluates the effect of cold application after impacted third molar extractions.~     Patients have bilateral impacted third molar tooth included in this study. Patients do not~     applied cold after extraction of third molar on one side and applied cold cold after~     extraction of third molar on the other side.~   "
23310|NCT03261856|"~     Bloating, gas, pain and diarrhea are common complaints. Routine investigations are negative;~     these patients are labeled as IBS. In these patients, whether testing for carbohydrate~     malabsorption or small intestinal bacterial overgrowth (SIBO) is useful is unclear. We aim to~     assess the prevalence of SIBO, fructose and lactose intolerance, the usefulness of breath~     tests, and predictive value of pre-test symptoms.~   "
23311|NCT03261843|"~     the study aims to determine the effect of using Autologous platelet rich plasma on both the~     quality & rate of posterior lumbar interbody fusion & its outcome on the Patient regarding~     postoperative lumbar pain & functional outcome~   "
23312|NCT03261830|"~     The aim of this study is to determine if antibiotics affect the outcome after percutaneous~     surgery for pediatric supracondylar humerus fractures. The patient population will be~     recruited from the cohort presenting to Women and Children's Hospital for percutaneous~     fixation of pediatric supracondylar humerus fractures who meet the eligibility criteria and~     consent to taking part in the study. Patients will be followed up for 3-6 weeks depending on~     age, and will be evaluated on the presence or absence superficial or deep infection, VAS pain~     scores, time to healing, need for repeat casting, and loss of fixation.~   "
23313|NCT03261817|"~     In this study, an APA program by web (e-APA) will be offered to two groups of participants~     (21 patients and 21 healthy volunteers (HV)) in remote video (use of the SAPATIC (Santé~     Activités Physiques Adaptées utilisant les Technologies de l'Information et de la~     Communication) platform developed by the company V@SI). At the same time, two control groups,~     a group of 21 patients and a group of 21 HV will undergo an health education program (HE)~     through the collaborative SAPATIC health platform of V@Si and will constitute the control~     groups. The content of the APA sessions will be administered by V@Si. This program offers~     content aimed to improve aerobic capacity and muscular strength while relying on the~     motivation of the participants~   "
23314|NCT03261804|"~     To determine the effect of performing internal vaginal douching on the frequency and severity~     and type of vaginal infections in IUD users~   "
23315|NCT03261791|"~     In this phase 2 study, we aim to evaluate the effects and safety of adjuvant apatinib therapy~     for the patients who underwent R0 resection for hepatocellular carcinoma with portal vein~     tumor thrombus.~   "
23316|NCT03261778|"~     In a randomised prospective comparative Trial the investigators aim to compare the~     conservative Treatment of acromioclavicular dislocations (Rockwood III) with a conventional~     sling versus a Acromion 2.0 brace, which exerts a direct Reposition force on the Joint.~      The sling/brace will be worn for 6 weeks and the patients will be regularly checked~     clinically and radiologically.The investigators are interested in differences of shoulder~     function, Patient satisfaction as well as cosmetic and radiological results.~   "
23360|NCT03261206|"~     The purpose of this study is to assess whether withdrawal of aminosalicylate (5-ASA) is~     non-inferior to continuation of 5-ASA therapy in Crohn's disease (CD) subjects in remission.~   "
23361|NCT03261193|"~     Comparison of standard post-operative cesarean surgery pain management with regional post-op~     pain control.~   "
23317|NCT03261765|"~     The rate of cesarean section deliveries has increased dramatically worldwide in the last~     decades. While the cesarean birth rate was 4.5% in the USA in 1965, it was 31.8% according to~     2007 data and is thought to be over 50% at present. The reasons for this include advanced age~     of primigravida, a wide range of indications, patient requests, the frequency of women with~     previous cesareans, women's rejections to offers of sterilization, and the common usage of~     assisted reproductive techniques~   "
23318|NCT03261752|"~     Colo rectal cancer is one of the greatest ,mutual malignancies worldwide ,accounting for an~     estimated 1.3 million new cases and >500,000 mortality ⁄ year . is the fourth leading cause~     of cancer-associated mortality worldwide with speedily ,cumulative ,occurrence rate in the~     worldwide~   "
23319|NCT03261739|"~     BRB-018-001 is a multicenter, adaptive design, randomized, parallel group study to evaluate~     the safety, tolerability, and PK of repeat IV doses of RYI-018 in subjects with NAFLD.~   "
23320|NCT03261726|"~     Tumors arising from the VIIIth Nerve (vestibulo-cochlear nerve) typically present with~     progressive unilateral hearing loss and tinnitus. VIIIth Nerve tumors with documented growth~     on serial MRI scans typically lead to deafness in the affected ear over time. Radiation~     (Gamma Knife® or stereotactic radiosurgery) may preserve hearing in ~80% while surgery~     (middle cranial fossa or retrosigmoid approach) may preserve hearing in 16 - 40% of small~     tumors, although initial hearing preservation by both modalities may fail over time. Surgical~     resection via the translabyrinthine approach is the safest way to remove many of these~     tumors, but involves loss of all hearing. In all treatment modalities, the vascular supply~     (the labyrinthine artery, a terminal branch of AICA with no collaterals) to the cochlea is at~     risk. After devascularization, the cochlea frequently fills with fibrous tissue or ossifies~     (labyrinthitis ossificans), making it impossible to place a cochlear implant should it be~     required later. The incidence of this is 46% in our patients. This study seeks to determine~     the feasibility of preserving the cochlear duct with an obdurator so that patients undergoing~     translabyrinthine removal of VIIIth nerve tumors may retain the option of a cochlear implant~     at a later time.~   "
23321|NCT03261713|"~     Virtual reality (VR) training (VRT) uses computer software to track a user's movements and~     allow them to interact with a game presented on a TV. It is fun and engaging and may~     encourage the user to do more exercise. VRT is increasingly being used for rehabilitation~     after stroke. Patients often require ongoing therapy post-discharge from inpatient~     rehabilitation. Outpatient therapy may be unavailable due to waiting lists, transportation~     issues, distance etc.; therefore, home-based VRT may be the answer. Our objectives are to~     determine: 1) the feasibility of home-based VRT for stroke patients after discharge from~     hospital-based rehabilitation, and 2) the feasibility of a battery of outcome measures. Forty~     stroke rehabilitation patients will be recruited over 18 months and randomize them to~     experimental or control groups. VRT participants will be introduced to VRT at the hospital~     and a VRT system will be set up in their homes shortly after discharge. Control participants~     will be provided with games and apps on an iPad focusing on cognition and fine motor skills.~     Participants will be instructed to perform 30 minutes of VRT 5 days a week for 6 weeks.~     Training will be monitored remotely. Both groups will receive weekly phone calls to review~     their home activity and answer questions. Measurements will be made of standing balance and~     general function before and after training, and feasibility (compliance, enjoyment, safety).~   "
23322|NCT03261700|"~     Intimate partner violence (IPV) is a major health concern for women Veterans. IPV is~     associated with numerous physical and mental health conditions. VHA is implementing IPV~     screening programs to identify female patients who experience past-year IPV. Despite strong~     evidence that screening increases detection of IPV, less is established about how to~     intervene following IPV disclosure in health care settings, in order to improve health~     outcomes. Existing healthcare-based interventions result in minimal effects on health and~     well-being, likely because they are too brief and generic.~      In response, the PI has developed Recovering from IPV through Strengths and Empowerment~     (RISE), based on the IPV-related health care needs and preferences of women Veterans. RISE is~     designed to be delivered in primary care and is an individualized, variable-length,~     modular-based intervention that addresses~        -  safety planning;~        -  education on the health effects of IPV;~        -  increasing coping skills and self-care;~        -  enhancing social support;~        -  making difficult decisions; and~        -  connecting with resources. This study is aimed at refining and evaluating RISE for use~          with female VA patients who have experienced past-year IPV. This brief counseling~          intervention is intended to be administered in conjunction with primary care, as this is~          a frequent point of healthcare contact for women Veterans and where disclosure of IPV is~          most prevalent.~   "
23323|NCT03261687|"~     This study aimed to address whether a water exercise programme improves pain and quality of~     life in pregnant patients with Pelvic Girdle Pain (PGP) compared to a land-based exercise~     programme and the feasibility of undertaking a large-scale research programme.~   "
23324|NCT03261674|"~     The purpose of this clinical trial is to assess the relative efficacy of two~     non-pharmacological interventions for insomnia in Veterans suffering from chronic mild~     traumatic brain injury (mTBI).~   "
23325|NCT03261661|"~     The purpose of the proposed studies is to examine a reading intervention for fourth grade~     students with reading difficulties that integrate work in mindset (beliefs about whether~     abilities are innate or can be developed) with the academic component of reading.~     Specifically, the investigators will examine the extent to which integrating mindset~     intervention improves student response to reading intervention. The investigators will use~     previous research in intensive reading intervention for students with reading difficulties in~     the upper elementary grades to examine an intervention that addresses reading skill deficits,~     while also providing mindset training along with (Study 1) or embedded in (Study 2) the~     reading intervention. It is hypothesized that students in the reading intervention with~     mindset conditions will improve their reading outcomes more than students in the reading~     intervention only and business as usual groups.~   "
23326|NCT03261648|"~     Evaluate and compare the impact of partner's stress in the pain of the patient admitted in~     the emergency department~   "
23327|NCT03261635|"~     To evaluate whether indomethacin eyedrops plus intravitreal ranibizumab (IVR) provides~     additional benefit over IVR monotherapy for treatment of choroidal neovascularization (CNV)~     in age-related macular degeneration.~   "
23328|NCT03261622|"~     Sacral nerve stimulation (SNS) has over the last 20 years been recognised as an efficient~     treatment option for faecal incontinence (FI).~      In a selected patient group we have evidence that 90% of patients will have a successful test~     period (≥50% reduction in incontinence episodes). If preoperative there is motor response on~     at least 3 out of 4 poles on the lead, at a threshold ≤1.5 mAMP.~      Hypotheses In a selected patient group suffering from faecal incontinence a one-stage~     permanent implant will be possible. The functional results will be improved as more time can~     be spent finding the optimal pacemaker settings as the risk of infection is reduced compared~     to the stage implant. One-Stage implantation gives the opportunity to test the amount of~     placebo effect with SNS.~      During the first 3 months postoperative patients will be randomized to either stimulation~     amplitude set at 90% of sensory threshold (control group) or 3 periods of stimulation at~     0.05v (placebo), 50% and 90% of sensory threshold. Patients are randomized in a 1 to 2~     pattern. After the initial 3 months the stimulation amplitude is increased to sensory~     threshold. After six months the project ends and the number of patients achieving the 50%~     improvement in incontinence episodes are evaluated.~   "
23329|NCT03261609|"~     The purpose of the HAPI project is to study the overall health of preterm infants once they~     reach adulthood. The investigators would like to compare the health of adults born preterm~     with that of adults born full-term. They would also like to find the early signs, or~     biomarkers, of chronic diseases such as high blood pressure, diabetes, osteoporosis, and~     chronic lung diseases.~      Such biomarkers would allow for early diagnosis and prevention. Furthermore, the~     investigators would like to understand why some people born preterm are more likely to~     develop chronic disease. They believe that inflammation and oxidative stress may play a part.~     Oxidative stress is present when the body is not able to defend itself against oxygen-derived~     products that can damage our cells.~      To carry out this study, the investigators will examine 6 aspects of the health: (1) heart~     and circulation, (2) kidneys, (3) lungs, (4) metabolism - sugars and fats in the blood, (5)~     bones, and (6) eyes.~   "
23330|NCT03261596|"~     The Ghana study will hypothesize that both the multiple dose and single dose of mebendazole~     will achieve effective cure rates against hookworm among children and adolescents. This study~     is intended to be a pilot study for a planned Phase 3 registration trial of a new drug for~     hookworm, tribendimidine.~   "
23331|NCT03261583|"~     Observational study.~   "
23332|NCT03261570|"~     Postural tachycardia syndrome (POTS), is the chronic form of orthostatic intolerance~     associated with excessive upright tachycardia, and occurs predominantly in young females~     (>85%). Among its most troubling symptoms are lightheadedness, fatigue, and decreased memory~     often called brain fog by patients. Task-related neurovascular coupling (NVC) links neural~     activity to an increase in CBF known as functional hyperemia. Although memory task~     performance and NVC deteriorated with angle of tilt in POTS but not healthy controls,~     cerebral blood flow (CBF) remained similar to control. Instead, the investigators observed~     extensive narrow band low frequency (0.07-0.13 Hz) oscillations in BP (OBP) that entrained~     and amplified oscillations in CBF (OCBF). OBP and OCBF increased with tilt angle and caused~     impaired working memory and reduced functional hyperemia. The cardiovagal baroreflex couples~     BP to HR to buffer BP changes. The investigators hypothesize that the cardiovagal baroreflex~     becomes progressively impaired with orthostasis in POTS, but not in healthy volunteers, and~     accounts for OBP, OCBF, and loss of NVC; further, improving the baroreflex reduces OBP, OCBF~     and Brain Fog in POTS.~   "
23333|NCT03261557|"~     Cognitive-behavioral therapy (CBT) and social skills training (SST) are recommended~     psychological interventions to improve symptomatology and functional recovery in psychosis.~     In addition, CBT may reduce hyperactivation of the brain structures responsible for the~     stress response. In patients with early onset psychotic disorder (EOP) there are not any~     previous controlled study that has analyzed the efficacy of this type of intervention.~      The aim of this study is to investigate efficacy of CBT + SST in symptomatic and functional~     improvement after the treatment in patients with EOP. The study will also examine the~     potential effect of the intervention on neurobiological stress markers.~   "
23334|NCT03261544|"~     The purpose of this study is to assess the functional outcomes in patients undergoing~     proximal femur resection and reconstruction with an endoprosthesis, based on the abductor~     muscle repair technique. The investigators hypothesize that those patients who receive~     reattachment of the abductors directly into the prosthesis will have better functional~     outcomes overall. Furthermore, the investigators plan to develop a simple, cost effective,~     and reproducible method to assess abductor function at clinical post-operative visits through~     plain radiographs.~   "
23335|NCT03261531|"~     Investigators are doing this research study to find out the effect of T6 dermatomal~     electrical stimulation (delivered by a Transcutaneous Electrical Nerve Stimulation (TENS)~     unit) on appetite and weight loss.~   "
23336|NCT03261518|"~     In this study, the investigators aimed to evaluate the incidence of vena cava inferior~     diamater on ultrasound guidance of intravascular volume before diagnosis of contrast~      - enhanced CT for diagnostic purposes in ileus patients and to investigate the incidence and~     risk of developing contrast nephropathy due to contrast - enhanced CT.~   "
23337|NCT03261505|"~     The aim of this study is to investigate brain response and connectivity changes evoked by~     video-guided acupuncture imagery treatment (VGAIT) and verum and sham acupuncture in knee~     osteoarthritis patients to elucidate the underlying brain mechanisms of mind-body~     interaction, imagery, and acupuncture.~   "
23338|NCT03261492|"~     The goal of SAGE is to determine if a garden-based curriculum can increase physical activity~     and improve nutrition in young children at early care and education centers (ECEC) throughout~     Phoenix~   "
23362|NCT03261180|"~     This randomized clinical trial studies how well Nestle Impact Advanced Recovery works in~     improving surgery recovery in patients with head and neck cancer. Adding a nutritional~     supplement, such as Nestle Impact Advanced Recovery to a regular diet before and after head~     and neck cancer surgery may help to decrease the number of wound complications after surgery.~   "
23423|NCT03260387|"~     Multi-center, prospective, observational cohort study of patients undergoing total~     pancreatectomy with islet autotransplantation (TPIAT)~   "
27655|NCT03204994|"~     This study aims to assess the lymphatic drainage of rectal tumours by using ICG as a~     fluorescent non-specific marker. As a feasibility study, it will also assess its technique~     and timing along with its ability to assist in removing lymph nodes when it is clinically~     indicated.~   "
23339|NCT03261479|"~     We are proposing a two-stage, prospective, cohort study of 138 subjects > 28 days old and <~     18 years old with respiratory distress, already getting a chest x-ray as part of their~     routine clinical care, who will get thermal pictures of their chest at the Massachusetts~     General Hospital (MGH) Emergency Department, Pediatric Wards, and Pediatric Intensive Care~     Unit. The thermal cameras will measure skin temperature, by taking a picture, in a~     non-contact way. We will recruit 138 patients using the FLIR ONE thermal imaging camera for~     iPhone and the newly designed irPNA application. The FLIR ONE thermal imaging camera will be~     attached to a study-designated iPhone which will only have the ability to take pictures. This~     phone will not have the capability to make calls or use the internet. The iPhone will be~     password protected, as encrypted by Partners regulations. Demographic and diagnostic data~     will be collected from patient charts.~   "
23340|NCT03261466|"~     Obesity is a major, public health concern that affects at least 400 million individuals and~     is associated with severe disorders including diabetes and cancers. Worldwide, the prevalence~     of overweight and obesity combined in children, adolescents and youth, between 1980 and 2013,~     increased to 47.1%, with alarming data also in developing countries. Obesity is often caused~     by imbalance between excessive caloric intake and reduced physical activity.~      Recently, microbial changes in the human gut was proposed to be another possible cause of~     obesity and it was found that the gut microbes from fecal samples contained 3.3 million~     non-redundant microbial genes. However, it is still poorly understood how the dynamics and~     composition of the intestinal microbiota are affected by diet or other lifestyle factors.~     Moreover it has been difficult to characterize the composition of the human gut microbiota~     due to large variations between individuals.~      The role of the digestive microbiota in the human body is still largely unknown, but the~     bacteria of the gut flora do contribute enzymes that are absent in humans for food digestion.~     Moreover, the link between obesity and the microbiota is likely to be more sophisticated than~     the simple phylum-level Bacteroidetes: Firmicutes ratio that was initially identified, and it~     is likely to involve a microbiota-diet interaction.~      Obese and lean subjects presented increased levels of different bacterial populations. It is~     hypothesized that the obese microbiome is set up to extract more calories from the daily~     intake when compared to the microbiome of lean counterparts. In addition, a caloric diet~     restriction impacted the composition of the gut microbiota in obese/overweight individuals~     and weight loss.~      In lean subjects there are Coriobacteriaceae, Lactobacillus, Enterococcus, Faecalibacterium~     prausnitzii, Prevotella, Clostridium Eubacterium, E. coli and Staphilococcus. By contrast,~     Bifidobacterium, Methanobrevibacter, Xylanibacter, Bacteroides characterize the composition~     of lean gut microbiota.~      For this reason, in a cohort of obese paediatric subjects with visceral adiposity, the aim of~     the study is to assess the efficacy of a supplementation with probiotic bifidobacteria with~     respect to a conventional treatment on weight loss and improvement of cardio-metabolic risk~     factors.~   "
23341|NCT03261453|"~     The primary objective of this study is to demonstrate the safety and efficacy of the Elipse~     Gastric Balloon System for the treatment of obese adults.~   "
23342|NCT03261440|"~     Weaning patients off ventilation in an ICU is sometimes difficult, because of three major~     inter-related etiologies: impaired lung, heart and diaphragm function. In this context,~     ultrasonography during tests to wean patients off ventilation could make it possible to~     diagnose cardiac dysfunction, a loss of pulmonary aeration or diaphragm dysfunction and thus~     reduce the number of failures at extubation.~      The study will be carried out in 100 patients on mechanical ventilation following abdominal~     or heart surgery, who will have echocardiography, and pulmonary and diaphragm~     ultrasonography.~   "
23343|NCT03261427|"~     The purpose of this trial to compare the pharmacokinetic characteristics of~     YNP-1807(Pregabalin 330mg) and Lyrica capsule(Pregabalin 150mg). YNP-1807 is made by Yungjin~     Pharm. Primary endpoints are AUClast and Cmax and secondary endpoints are AUCinf, Tmax, t1/2,~     Vd/f, CL/f.~   "
23344|NCT03261414|"~     The aim of this study will be to show a decrease in postoperative morphine consumption by the~     practice of perioperative self-hypnosis in patients undergoing laparoscopic ileo-caecal~     resection for Crohn's disease~   "
23345|NCT03261401|"~     The primary purpose of this study is to investigate the safety and tolerability of M5717 and~     to characterize the Pharmacokinetics /Pharmacodynamic relationship between M5717 PK and~     parasite clearance in healthy subjects following infection with Plasmodium falciparum.~   "
23346|NCT03261388|"~     At Courage Kenny Rehabilitation Institute, rehabilitation for individuals with spinal cord~     injury (SCI) is being led by the NIH funded NeuroRecovery Network (NRN) Community Fitness and~     Wellness Program through the Activity-Based Locomotor Exercise Program (ABLE). Any individual~     with a spinal cord injury who is eligible for the ABLE Program is eligible for participation~     in the NeuroRecovery Network Research Project (NRN). The purpose of the ABLE POWER Study is~     to evaluate the effectiveness of activity-based locomotor exercise programs in individuals~     with SCI through a wait-list controlled design. Individuals who have a spinal cord injury and~     are on the wait list for ABLE will be enrolled in this project for a year while they wait for~     an opening in the ABLE program. Changes that occur while participants are on the wait list~     will be compared to changes that occur after they are enrolled in ABLE. A difference in the~     rate of improvement after enrollment in the intervention would be attributed to the ABLE~     intervention. Individuals participating in the ABLE program will receive the ABLE~     intervention regardless of participation in the ABLE POWER research study. In this design,~     there will be two measures in the year prior to enrollment in ABLE, and two measures in the~     year after enrollment, and the two time periods would be compared to the data collected at~     enrollment into ABLE.~   "
23347|NCT03261375|"~     This is a multicentre clinical trial to evaluate safety and efficacy of renal denervation~     system in treatment of hypertension. Hypertensive patients who meet enrollment criteria will~     be randomized into treatment group who will receive standardized drugs and renal denervation~     treatments, or control group who will receive standardized drugs and a sham procedure (renal~     artery angiography only without denervation). The patients will be monitored for blood~     pressure changes and any adverse events for 6 months. The safety and efficacy of the device~     will be evaluated by comparing blood pressure levels and adverse event episodes between the~     two groups.~   "
23348|NCT03261362|"~     The purpose of this study is to clarify the role of the branched-chain amino acids in the~     development of Insulin resistance in patients with diabetes~   "
23415|NCT03260491|"~     This study has two parts: dose escalation and dose expansion.~      The primary objectives are:~        -  For Dose Escalation, to assess the safety and tolerability of U3-1402 in the study~          population and to determine the recommended dose for expansion of U3-1402 in the study~          population~        -  For Dose Expansion, to assess the safety and tolerability of U3-1402 in the study~          population~      The number of treatment cycles is not fixed in this study. Participants will continue study~     treatment for 36 months unless they decide not to (withdraw consent), their disease gets~     worse [progressive disease (PD)], or side effects become unacceptable (unacceptable toxicity)~     or other stopping reasons have been met.~   "
23349|NCT03261349|"~     We and other investigators have revealed an association between Hepatitis C virus (HCV)~     seropositivity and an increased risk of developing marginal zone B-cell lymphoma (MZ),~     lymphoplasmacytic lymphoma (LPL, also known as Waldenström's macroglobulinemia), follicular~     lymphoma (FL), and diffuse large B-cell lymphoma (DLBCL). The sustained virologic response~     (SVR) to treatment with interferon or pegylated (Peg)IFN with ribavirin was closely~     associated with the regression of HCV-associated B-cell NHL (mainly MZL, and LPL).~      Currently, the second-generation direct-acting antiviral agents (DAAs), such as sofosbuvir,~     have been shown to have a higher cure rate, less side effects, and a shorter duration of~     therapy for chronic HCV infection. After the approval of DAA for HCV therapy, several recent~     anecdotal case reports showed that indolent low-grade B-cell NHLs regressed after HCV~     clearance by DAAs. It is noted that the time to complete remission of these lymphomas was~     around 20 to 24 weeks after starting DAAs. These findings indicate that DAAs can eradicate~     the trigger of lymphomagenesis by curing chronic HCV infection.~      Because DAAs are more potent and efficient than pegylated (Peg) interferon plus ribavirin and~     well-tolerated for the treatment of HCV infection, it is reasonable to use DAAs as the~     frontline treatment for HCV-positive patients with indolent B-cell NHL, such as MZL, LPL, and~     low-grade FL, who do not require immediate cytoreductive therapy. The aim of this proposal is~     to assess whether Harvoni® (ledipasvir and sofosbuvir) could eradicate HCV and lead to~     durable complete remission of these lymphomas..~   "
23350|NCT03261336|"~     The aim of this study is to estimate the PSA response rate with the use of ketoconazole~     (400mg QD + hydrocortisone 20mg AM, 10 mg PM) among men with CRPC in whom disease has~     progressed despite abiraterone~   "
23351|NCT03261323|"~     The purpose of this study is to:~        1. Evaluate whether immediate or delayed reconstruction should be offered for breast~          reconstruction candidates with higher risk for surgical complications by comparing~          complications, quality of life, and hospital costs~        2. Determine the efficacy of risk reduction strategies for breast reconstruction patients~          with higher risk for surgical complications~   "
23352|NCT03261310|"~     The purpose of this study is to investigate the effectiveness of intravenous acetaminophen~     (Tylenol) for post operative pain control in patients undergoing craniotomies (brain surgery)~     and spine surgery. Studies have shown that intravenous acetaminophen is useful for post~     operative pain control in some operations but there have not been studies to evaluate the use~     of acetaminophen in craniotomies or spine surgery.~   "
23353|NCT03261297|"~     Chronic diarrhea is defined as stool volume of more than 10g/kg/day in toddlers/infants and~     greater than 200 g/day in older children that lasts for 14 days or more.~      Chronic diarrhea has many of causes can calcified as infectious & noninfectious causes.~        -  Infectious causes as: - Escherichia coli, Giardia Lamblia, tuberculosis, Clostridium~          difficile & Shigella.~        -  Noninfectious causes as(Abnormal digestive processes- Nutrient Mal -absorption- Immune/~          inflammatory- Defects of electrolyte And metaboliteTransport- Motility disorders-~          Diarrhea associated With exogenous substances)~      There are four basic pathophysiological categories of diarrhea: as ( osmotic diarrhea-~     secretory diarrheas- motility related diarrhea- Inflammatory diarrhea)~   "
23354|NCT03261284|"~     This was a prospective, three arms, randomized controlled study.~   "
23355|NCT03261271|"~     The purpose of this study is to test how a weight management program affects substances in~     the blood called biomarkers that can show the presence or severity of cancer, compared to a~     standardized diet and exercise educational flyer.~   "
23356|NCT03261258|"~     In the vast majority of cases, the person of trust (or contact person) is not designated by~     the patient (emergency, severe disease situations, coma, sedation, etc.). The healthcare team~     thus identifies a person who 1) may not be the person the patient would have designated and~     2) may not be the most suitable to take on this responsibility. Though the first point is not~     easy, the main difficulty for the clinician is to know if he is dealing with the right~     person for the job, meaning a person who is able to take on the responsibility of the~     contact person. This is a heavy responsibility in terms of the information given, of passing~     on this information to relatives and friends, of consulting the doctors, of help or support~     in medical decisions, etc. This responsibility may also be difficult for one person alone to~     take on and it may be helpful to share it between several friends or relatives. In a princeps~     study (QUENOT, 2015), it was shown that the process used by the healthcare team to designate~     a contact person was based on criteria such as knowledge of the wishes and values of the~     patient, the strength of the relationship with the patient, and the person of trust~     designated before admission to the ICU. However, we do not know what criteria are used by the~     patients themselves or those used by their close friends and relatives. This study will make~     it possible to determine and to measure the possible differences between the criteria used by~     the ICU healthcare team (REPERE I), those used by patients (REPERE III) and finally, those~     used by close friends and relatives (REPERE II).~      In order to do this, 300 persons (150 patients and 150 relatives/friends) will complete~     questionnaires.~   "
23357|NCT03261245|"~     This retrospective study aimed to analyse the relationship between multi-exposure to noise~     and air pollution the onset of hypertension disorders during pregnancy~      It will be conducted in 2650 mothers who gave birth at Dijon or Besançon CHU between 2005 and~     2009 split into two groups:~        -  530 cases (women who experienced hypertension disorders during pregnancy~        -  2120 controls (women who did not experience a hypertension disorder during pregnancy)~   "
23358|NCT03261232|"~     Through this retrospective observational study (over 4 years; period analysed: 1st January~     2011 to 31st December 2014), we looked for prognostic factors associated with better survival~     in refractory cardiac arrest by:~        -  assessing the overall survival rate~        -  evaluating the frequency of intra et extra-hospital events and by comparing these with~          the survival rate~        -  studying no flow, low flow, rhythm at initial management, troponinemia, lactatemia and~          blood pH in the different groups.~   "
23359|NCT03261219|"~     Intrapulmonary Percussive Ventilation (IPV) will show greater improvements in Forced~     Expiatory Volume in 1 second (FEV1) shorter duration of stay, and greater time to next~     pulmonary exacerbation in pediatric Cystic Fibrosis patients admitted for pulmonary~     exacerbation.~      FEV1 is a measurement of obstruction in the airway which is seen to be elevated in CF~     patients with worsening lung disease. FEV1 is used as a primary endpoint in pulmonary trials~     because it is an acute indicator of worsening or improving lung function.~   "
23363|NCT03261167|"~     Botulinum toxin A (GSK1358820) is a sterile, purified type A botulinum neurotoxin complex. In~     Japan, 240 units of botulinum toxin A are approved as a maximum dose per administration for~     upper limb spasticity. This study is planned to evaluate the effectiveness and safety of 400~     units of botulinum toxin A which can help to increase the maximum dose per administration to~     400 units from 240 units as the treatment with 240 units is considered insufficient in~     subjects with post-stroke upper limb spasticity. Approximately 120 subjects will be~     randomized to receive either 400 or 240 units of botulinum toxin A in double blind phase~     followed by open-label phase in which 400 units of the study treatment will be injected in~     both the groups. The study period will be up to 52 weeks, consisting of a screening phase up~     to 4 weeks, minimum 12-week double blind phase (Part 1), maximum 36- week open-label phase~     (12 weeks per cycle with 3 treatment phases: Part 2, Part 3 and Part 4).~   "
23364|NCT03261154|"~     Incidence of End Stage Renal Disease (ESRD) amongst elderly patient group is continuously~     increasing with population aging progressing. Mineral and bone disorder (MBD) is a common~     complication caused by ESRD, it raises the incidence of cardiovascular disease (CVD) in~     hemodialysis patients, as well as mortality.~      Joint effects of Kidney failure and aging on elderly hemodialysis patients make the~     contribution factors of CKD-MBD quite complex, and it also leads to differences in clinic~     manifestation between elderly hemodialysis patients and non-elderly hemodialysis patients.~     Since not much studies had been done for this specific subject, thus, research on elderly~     patients who is taking Maintenance hemodialysis is very necessary. This study is a~     retrospective research to identify optimized target value of Calcium and Phosphorus for~     elderly patients taking maintenance hemodialysis and hence provide guidance for clinical~     practices. The data for this study will be provided by Beijing Blood Purification Quality~     Control and Improvement Center. Clinical files and Calcium and Phosphorus metabolic indices~     will be collected amongst elderly patients who were elder than 65 years and was taking~     maintenance hemodialysis between Jan 1st, 2012 through Dec 31st, 2016. Relationship between~     Calcium level, Phosphorus level, iPTH index, all-cause mortality and CVD caused mortality~     will be analyzed to identify optimized range of target Calcium levels, Phosphorus level for~     hemodialysis treatment~   "
23365|NCT03261141|"~     The aim of this study is to assess the Correlation between The Arabic Pediatric Voice Related~     Quality of Life (PV-RQOL), The Auditory Perceptual Assessment and Acoustic Analysis of voice~     of dysphonic children. This is important to provide an efficient therapeutic strategy for~     these children.~   "
23366|NCT03261128|"~     Many cancers are diagnosed after 75 years. Treatment in chemotherapy begins without evidence~     of geriatric risk factors. A new tool for screening for geriatric fragilities is used, a~     self-administered questionnaire carried out by the patient before each chemotherapy cure. The~     objective is to secure the quality of patient care and to detect the appearance and / or~     aggravation of geriatric fragilities.~   "
23367|NCT03261115|"~     The aim of this randomized controlled trial. is to test the efficacy of topical anesthesia~     against the use of no topical agent during buccal infiltration in maxillary anterior teeth.~     The rationale behind this comparison is to evaluate the practical, clinical outcome of not~     using any topical agent if in fact topical anesthesia does not reduce pain as reported by~     various studies and if consequently its usage was to be discontinued.~   "
23368|NCT03261102|"~     To investigate the influence of early therapeutic drug monitoring and dose optimization on~     disease outcome in Crohn's patients treated with Adalimumab.~   "
23369|NCT03261089|"~     Cardiovascular disease remains the leading cause of death in the United States. Mortality~     rates of cardiac arrest range from 60-85%, and approximately 80% of survivors are initially~     comatose. Of those who survive, 50% are left with a permanent neurological disability, and~     only 10% are able to resume their former lifestyle. Early prognosis of comatose patients~     after cardiac arrest is critical for management of these patients, yet predicting outcome for~     these patients remains quite challenging.~      The primary study objective of MOCHA is to develop an accurate and reliable assessment~     algorithm for determining neurologic prognosis in patients initially unconscious (no eye~     opening, GCS-M<6 and not following commands) post-cardiac arrest, using multiple prognostic~     modalities at standardized time points.~   "
23370|NCT03261076|"~     The current literature on academic skill difficulties, whether considered as part of the~     continuum of ability or as a specific learning disability (LD), indicates that these problems~     often coexist with conduct problems and juvenile delinquency, and are risk factors for~     initial law-breaking behavior and for its persistence. However, less is understood about how~     this relationship develops. It is these broad questions that this project seeks to address.~     First, what is the causal pathway? Does LD cause delinquency, delinquency cause LD, or are~     both caused by something else? And can big data analytics applied to statewide datasets of~     information about juvenile justice (JJ) involvement help to answer this question? Second, as~     it is known that learning to read and do math (and thus becoming more employable) increases~     the likelihood of desistance (i.e., not committing any more illegal acts), what are the~     necessary parts of an intervention designed to teach these skills? And what role might~     technology play in such an intervention? To answer these questions, we will implement a study~     that includes two components, (a) a big data component and (b) an intervention component. For~     (a), we will work with a large historical dataset from the Harris County Juvenile Probation~     Department. For (b), we will work, in total, with 192 (48 per year) delinquent youth with~     severe LD in residential placement. These individuals, in a nonconcurrent multiple baseline~     design, will be offered an educational therapy designed to address severe reading problems in~     juvenile detainees using a novel mixed media intervention in which the person-to-person~     intensive 1:1 component is completed while youth are in residential settings (24 sessions,~     delivered in 90 minute settings 3 times a week) and a gamified educational smartphone~     learning tool follow-up completed upon release (with appropriate network fidelity monitoring~     and participant reinforcement). The person-to-person component is developed specifically for~     juvenile offenders with severe LD, combining two well-established and highly-regarded~     intervention programs designed to systematically build students' repertoire of~     grapheme-phoneme correspondence rules as well as develop comprehensive reading skills, from~     beginning reading to proficiency.~   "
23371|NCT03261063|"~     The study is a prospective, single arm, non-blinded, multi-site study conducted in mainland~     China.~   "
23454|NCT03259984|"~     The investigators are trying to understand the role of DNA (deoxyribonucleic acid)~     methylation in insulin resistance in skeletal muscle and blood tissues. DNA methylation is a~     normal chemical process in the body that modifies DNA. By studying this, the investigators~     hope to better understand the causes of insulin resistance.~   "
23537|NCT03258892|"~     This randomized pilot clinical trial studies how well the Sarcoma Treatment Guide works in~     improving self-monitoring in patients with sarcoma who are receiving chemotherapy. The~     Sarcoma Treatment Guide may help patients with sarcoma to be better informed, become more~     engaged with care, encourage communication, and to better manage side effects associated with~     chemotherapy treatments in order to improve quality of life.~   "
23372|NCT03261050|"~     Most people with an eating disorder (ED) do not receive good treatment. The investigators~     have developed a new brief group treatment that is supposed to work by reducing how much~     women with an ED value the impossible thinness standard promoted by the media and how much~     they value/crave binge foods. The investigators want to test whether the treatment actually~     changes those two mechanisms using brain scan data, which is more objective than completing~     questionnaires and even interviews.~      In the first phase of the study (R61), the investigators will compare women in the treatment~     versus those on a wait-list. If the investigators can show that the treatment works (does~     what the investigators think it does) compared to no active treatment (women will be allowed~     to seek and receive outside help but investigators will not provide it until after the~     wait-list), investigators will conduct the second phase of study (R33),where they will~     randomly assign women with an ED to either the new treatment or to a group treatment that~     represents what many college mental health clinics provide to their clients with ED.~   "
23373|NCT03261037|"~     This international clinical study will enroll participants with a suspected diagnosis of~     IPF/ILD. This study will characterize the disease behavior of IPF and ILD in the~     peri-diagnostic period. This objective will be achieved using a multidimensional approach~     assessing changes in pulmonary function, measured by daily handheld spirometry and site~     spirometry as well as assessing physical functional capacity at home (accelerometry) and at~     site (6-minute walk tests [6MWT]). Daily handheld spirometry or physical functional capacity~     assessments are not routinely performed in this participant population. By following~     participants' lung function before and after diagnosis using home spirometry, levels of~     physical activity, as well as self-assessment data from the participants (patient reported~     outcomes; PRO), the study would provide potentially more rapid information on disease~     behavior and eventually progression compared to usual clinic measurements that occur only~     every 3-6 months. By receiving data from daily handheld spirometry measurements, treating~     physicians may have an improved chance of detecting earlier and outside of hospital visits a~     decline in lung function that could potentially lead to improvements in both diagnosis and~     treatment for participants with IPF/ILD.~   "
23374|NCT03261024|"~     This study is a Randomized clinical trial comparing the effectiveness of two different~     mechanics during maxillary en-masse retraction in adult patients. Patients will be randomly~     divided into two groups:Friction and frictionless mechanics. Mini screws will be used in both~     group to ensure maximum anchorage during retraction. Lateral cephalometric radiographs and~     dental models will be taken for each patients pre and post -retraction. Following complete~     anterior segment retraction, the rate and duration of retraction will be evaluated for both~     groups as well as patient satisfaction with treatment. Changes in incisors inclination and~     soft tissue as well as anchorage loss will be also assessed.~   "
23375|NCT03261011|"~     This study is to characterize the safety, tolerability, pharmacokinetics (PK),~     immunogenicity, pharmacodynamics (PD) and anti-tumor activity of AK104 as a single agent in~     adult subjects with advanced solid tumor malignancies. The study consists of a dose~     escalation phase (Phase 1a) to determine the maximum tolerated dose (MTD), or recommended~     Phase 2 dose (RP2D) for AK104 as a single agent, and a dose expansion phase (Phase 1b) which~     will characterize treatment of AK104 as a single agent at the MTD or RP2D.~   "
23376|NCT03260998|"~     Diabetes Mellitus type 1 is characterized by an absolute insulin deficiency caused by~     T-cell-mediated autoimmune destruction of pancreatic β-cells . It is the predominant form of~     diabetes mellitus during childhood and adolescence. Hyperglycemia is a major cause of~     vascular and neuropathic complications that are seen in patients with diabetes mellitus type~     1.~   "
23377|NCT03260985|"~     This is a demonstration project focused on translating neuroscience insights into clinical~     practice. The researchers will evaluate how neuroscience assessments may be applied in the~     clinical setting to help inform care decisions. The aim of the study is to undertake a~     pragmatic pilot trial to assess whether the inclusion of structured feedback from~     neuroscience assessments has an effect on improving patient outcomes. The study will~     investigate how neuroscience assessments can be integrated into and improve clinical care.~     The impact of sharing information and conclusions from these assessments with psychiatric~     providers will be explored. Outcomes will include symptoms, social/occupational function and~     qualify of life.~   "
23378|NCT03260972|"~     Objective The objective of this study is to test the hypothesis that instillation of~     intra-abdominal chloroprocaine during cesarean deliveries is associated with decreased~     postoperative pain and nausea compared to placebo, without increasing intraoperative and~     postoperative complications.~      Methods The investigators plan to randomize about 150 women undergoing primary and repeat~     cesarean deliveries to intra-abdominal chloroprocaine versus placebo prior to abdominal~     closure. Women will be excluded if they have ascertained or presumptive hypersensitivity to~     the ester type and major anesthetics; if they have chronic pelvic pain or if they refuse to~     participate in the study. The investigators' primary outcome measure will be postoperative~     pain as measured by visual analogue scale (VAS) at 1 hour after skin closure. Secondary~     outcomes will include objective pain as measured by VAS at 2, 6, 24 and 48 hours at rest and~     during mobilization, adverse effects of chloroprocaine (gastrointestinal side effects,~     pruritus), concomitant analgesic requirement, hospital readmissions and length of hospital~     stay. Analysis will follow the intention-to-treat principle.~      The investigators will also be studying the concentration/effect (PKPD) relationship of~     chloroprocaine use for pain control in the postpartum period. The time courses of the plasma~     concentrations of chloroprocaine will be analyzed with mixed effects~     pharmacokinetic-pharmacodynamic (PKPD).~   "
23379|NCT03260959|"~     Experience of the father following the announcement of a first pregnancy Its context,~     immediate reactions and actions. Possible impact of this moment of life a few months or years~     later?~   "
23464|NCT03259854|"~     Conventional mechanical ventilation is a core feature of intensive care. Weaning and removal~     of endotracheal tube are crucial processes, which often account for a considerable part of~     Conventional mechanical ventilation total time. Unsuccessful extubation has been noted to be~     associated with an increase of both morbidity and mortality in adult and pediatric patients~   "
23465|NCT03259841|"~     Investigators assess the gastric contents by ultrasonography in fasted patients undergoing~     cholecystectomy.~   "
23380|NCT03260946|"~     Palliative care centres in Lyon, France as well as the disclosure of Complementary and~     Alternative Medicine and conventional healthcare use to conventional and Complementary and~     Alternative Medicine practitioners respectively.~      These aims will be achieved through the following objectives:~        1. Describe the prevalence of Complementary and Alternative Medicine practitioner and~          product use in the outpatient population of palliative care centres in Lyon, France~        2. Describe the characteristics of Complementary and Alternative Medicine users the~          outpatient population of palliative care centres in Lyon, France~        3. Estimate the Complementary and Alternative Medicine expenditure of the outpatient~          population of palliative care centres in Lyon, France~        4. Describe the rates of disclosure of both Complementary and Alternative Medicine and~          conventional health care to health professionals by the outpatient population of~          palliative care centres in Lyon, France~        5. Describe the reasons for disclosure or non-disclosure of both Complementary and~          Alternative Medicine and conventional health care to health professionals by the~          outpatient population of palliative care centres in Lyon, France~   "
23381|NCT03260933|"~     This is a qualitative interview study investigating patients', carers' and providers'~     perspectives on integrated care and integrated care pathways for frail older people in~     Lambeth and Southwark, south London.~   "
23382|NCT03260920|"~     The purpose of this study is to assess the safety, tolerability and effects on behaviour of~     Syntocinon given intranasally (by a spray into the nostrils) compared to placebo (an inactive~     saline substance that contains no medication) in participants with frontotemporal~     dementia/Pick's disease. This study will take place in approximately 15 centres across Canada~     and the United States. Approximately 112 patients in total will be enrolled in this study. In~     the first phase we will examine which of three different dosing schedules of oxytocin may be~     more effective. In the second phase of the study, patients entering the study will be~     randomized to the oxytocin dosing schedule that appeared most effective in the first phase.~   "
23383|NCT03260907|"~     The purpose of this study is to verify the efficacy and safety of electroacupuncture~     treatment of postmenopausal women with overactive bladder (OAB).~   "
23384|NCT03260894|"~     The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus~     epacadostat compared to sunitinib or pazopanib in participants with locally~     advanced/metastatic renal cell carcinoma (mRCC) with clear cell component who have not~     received prior systemic therapy for their mRCC.~   "
23385|NCT03260881|"~     Epicardial adipose tissue (EAT) is the visceral fat of the heart. EAT could locally affect~     the coronary arteries through local secretion of pro-inflammatory cytokines. EAT plays a role~     in the development of the coronary artery disease (CAD). EAT is a highly enriched with genes~     involved in inflammation. Given its rapid metabolism and simple measurability, as first~     developed by Iacobellis, EAT serves as target for medications targeting the fat.~     Glucagon-like peptide-1 agonists (GLP-1A) are anti-diabetic medications with recently~     suggested cardio-protective properties. Liraglutide, a GLP-1A, has recently shown to reduce~     the cardiovascular risk. Iacobellis'group found that EAT thickness decreased by an~     unprecedented 36% after 12 weeks of treatment with liraglutide. Remarkably, Iacobellis'group~     found for the first time that human EAT express GLP-1 Receptor (GLP-1R). GLP-1A effects may~     be therefore visceral fat specific and target EAT. Based on these preliminary data, we~     hypothesize that treatment with liraglutide will significantly and rapidly reduce EAT~     inflammation. Decreased EAT inflammation can reduce the burden of the coronary plaques. We~     will test our hypothesis in a 12-week randomized, double-blind, placebo-controlled,~     interventional study in 40 patients with type 2 diabetes mellitus (T2DM), and CAD, with an~     acceptable glycemic control on their current diabetes regimen who require elective coronary~     artery bypass graft (CABG) regardless of their participation in the study. Inclusion criteria~     for body fat markers will rule out the confounding effect of different body fast distribution~     at baseline. Interim fructosamine test will insure glycemic equipoise between study arms.~     Study subjects will be randomized in two groups of 20 patients to receive additional~     liraglutide or to remain on current treatment/ placebo prior to cardiac surgery. CAD subjects~     not allocated to liraglutide will be started on a supervised low calorie diet (LCD) to~     achieve approximately 5% of weight loss after 12 weeks to avoid the confounding effect of~     weight loss on the study outcomes. EAT samples will be collected during cardiac surgery and~     processed for analysis of mRNA and protein expression of EAT inflammatory genes such as Tumor~     Necrosis Factor-alpha (TNF-α) and Interleukin 6 (IL-6), and GLP-1R.~   "
23386|NCT03260868|"~     Primary Objective:~      To evaluate the effect of virtual approach via novel technologies versus traditional study~     conduct on glycemic control in terms of glycated hemoglobin A1c (HbA1c).~      Secondary Objective:~      To evaluate the appropriate utilization of virtual approach via novel technologies during the~     study and to assess the effect of the virtual versus traditional study conduct on multiple~     outcomes in terms of study methodology and diabetes management.~   "
23387|NCT03260855|"~     Cancer survivorship has become an important aspect of oncology research due to the risk of~     physical and psychosocial complications. These latter concerns 50 % of patients. So, the aim~     of this research is to measure frequency and intensity of one of these issues: the fear of~     cancer recurrence (FCR) in the lymphoma survivorship beginning, at M0.~   "
23388|NCT03260842|"~     Bio-repository to collect bio-specimens from patients with 1) pancreatic cysts and 2)~     patients at high risk, defined by family history and/or genetic mutations, for pancreatic~     cancer.~   "
23389|NCT03260829|"~     efficacy of the injectable vitamin C to reduce the time of canine traction~   "
23390|NCT03260816|"~     The Advancing Child Competencies by Extending Supported Services (ACCESS) for Families~     Program is a study funded by the National Institutes of Health to explore behavior and~     developmental problems among young children aging out of Early Steps (Part C). All families~     will participate in five evaluations in their home to learn more about their child's behavior~     and development. Families also may receive treatment designed to help change their child's~     behaviors that will be conducted over the Internet using a tablet.~   "
23416|NCT03260478|"~     Most trauma deaths are related to traumatic brain injury (TBI). Although the management of~     patients has improved, mortality remains unacceptably high, and half of survivors of moderate~     and severe TBI are left with major functional impairment. Current management guidelines are~     based on limited evidence and practice is highly variable. Most acutely ill patients with TBI~     will develop anemia, which may decrease oxygen delivery to a fragile brain. While clinical~     practice is moving towards transfusing at low hemoglobin (Hb) levels, experts have expressed~     concerns regarding restrictive strategies, which may adversely affect clinical outcomes in~     TBI. Our primary objective is to evaluate the effect of red blood cell (RBC) transfusion~     thresholds on neurological functional outcome. We hypothesize that a liberal transfusion~     strategy improves outcomes compared to a restrictive strategy.~   "
23417|NCT03260465|"~     This is a randomized controlled trial with the seleXys PC cup and RM Pressfit vitamys cup in~     combination with the optimys short stem. Wear rate and migration is assessed with roentgen~     stereophotogrammetric analysis (RSA) measurements.~   "
23391|NCT03260803|"~     Osteoporosis fractures impose a significant economic burden on the health system. There is~     evidence that osteoporosis has a high prevalence in Iran (4.8% for men and 7.7% for women),~     and the frequency of osteopenia is 36.8% for men and 39.3% for women in Iran Accordingly, the~     prevention of osteopenia progression towards osteoporosis has been considered as an important~     issue in medicine. Bone is a dynamic tissue that is constantly being remodeled thus the~     equilibrium between bone formation and resorption done by simultaneously regulating~     osteoclasts and osteoblasts is important. Imbalance between bone deposition and resorption~     contributes to reducing bone mineral density and hence increasing the risk of osteoporosis~      Recently, new therapies have been focused on use of medicinal herbs, especially~     phytochemicals. Among phytochemicals, phytonutrients, and especially polyphenols, can act~     both on osteoblast and on osteoclast.~      Pine bark extract (oligopin) is a rich source of polyphenols that exerts strong antioxidant~     and anti-inflammatory activities. It has also beneficial effects on bone turnover based on in~     vitro studies and animal models. Investigators aimed to investigate the effects of oligopin~     on bone turnover markers and plasma and peripheral mononuclear cells oxidative stress in~     postmenopausal women with osteopenia in a double-blind randomized clinical trial.~     Participants are forty four women with osteopenia divided into two groups randomly (22,~     having oligopin, 150 mg, once daily, for 12 weeks). The 2nd group (22 women with osteopenia)~     receives the same amount of the placebo. At the first and the end of the study, blood sample~     are taken to measure in order to peripheral blood mononuclear cells isolation and plasma~     separation. The levels of bone alkaline phosphatase and carboxy terminal collagen type I in~     plasma oxidative stress markers such as total anti-oxidant capacity, malondialdehyde, and~     protein carbonyl were evaluated. Furthermore, oxidative stress will be evaluated in~     peripheral blood mononuclear cells by measurement of expression and activity of magnesium~     superoxide dismutase,catalase and Nuclear factor (erythroid-derived 2)-like 2.~   "
23392|NCT03260790|"~     Investigators are assessing if patients with asthma respond better to the Pneumovax vaccine~     if they are given Prevnar initially.~   "
23393|NCT03260777|"~     Alopecia is a common, distressing condition that is sometimes difficult to diagnose and~     treat.~      Losing hair is not usually health threatening; it can scar a young child's vulnerable~     self-esteem by causing immense psychological and emotional stress, not only to the patient,~     but also to the concerned parents and siblings; so the cause of hair loss should be diagnosed~     and treated early to overcome the resulting problems.~   "
23394|NCT03260764|"~     In this study, the investigators provide participants who had congenital cataract the~     multifocal contact lenses and bifocal spectacles in the purpose of seeking out a better way~     to make a definite diagnosis with high efficiency and accuracy, and report a prospective,~     randomized controlled study aiming at comparison of multifocal contact lenses and bifocal~     spectacles.~   "
23395|NCT03260751|"~     This study was conducted to investigate the effects of daily supplementation of Zingiber~     officinale Roscoe extract on body fat.~   "
23396|NCT03260738|"~     The objective of KERAAL technological project is to create a new intelligent robot which~     allows a humanoid robot to record then to show and to follow the progress of rehabilitation~     sessions proposed by a physiotherapist to a patient, the latter being able to practice~     without the physiotherapist. The final objective is to stimulate and increase the overseen~     time of rehabilitation. Poppy robot was chosen as it is able to realize all kind of movements~     notably movements of the spine with 5 degrees of freedom associated to the several levels of~     the spine. It will allow to address the population included in the protocol. RCOOL study~     tries to validate this prototype device as tool of rehabilitation.~      The main objective is the feasibility of the supervision by a humanoid robot of a succession~     of rehabilitation exercises.~      RCOOL study is a randomized clinical trial checked under single-blind condition to compare~     two rehabilitation strategies, one with exercises executed by the patients and supervised by~     Poppy and the other one with usual rehabilitation protocol.~   "
23397|NCT03260725|"~     The present study is leveraging a randomized-controlled design to evaluate an Internet-based~     format for the delivery of Parent-Child Interaction Therapy (I-PCIT). Drawing on~     videoteleconferencing technology, this format affords real-time interactions for the~     provision of care traditionally delivered in person, regardless of a family's geographic~     proximity to a mental health facility. Moreover, drawing on technological innovation to~     deliver interventions directly to families in their natural settings may extend the~     ecological validity of PCIT, as treatment is delivered in the very context in which child~     problems occur. Families seeking treatment for early child disruptive behavior problems~     (N=40) are being randomly assigned to either receive Internet-delivered PCIT or clinic-based~     PCIT. Outcomes and feasibility/acceptability will be assessed across the treatment phase as~     well as at post-treatment and 6-month follow-up.~   "
23398|NCT03260712|"~     This is a single-arm, multi-centre, phase II study in biliary tract cancer (BTC) patients.~     The main objective is to detect an increase in progression-free survival rate at 6 months~     (according to RECIST version 1.1) from 60% in patients with BTC treated with standard~     chemotherapy (CT) approach to 75% when treated with CT combined with pembrolizumab.~      Secondary objectives are:~        -  Assess the treatment efficacy in terms of overall survival, immune related~          progression-free survival, response rate (according to RECIST version 1.1), safety,~          symptom control and quality of life (QoL) (according to EORTC QoL C30 and BIL 21)~        -  Exploratory objectives include assessment of immunological response (cytokines,~          lymphocyte phenotype, immunoglobulins), and evaluation of pathological and clinical~          predictive factors for response/toxicity~        -  Translational research will focus on biomarkers for prediction of response and toxicity.~   "
23399|NCT03260699|"~     While bracing has been shown to be beneficial for patients with osteoarthritis (OA) in terms~     of function and strength, whether these unloader braces are also similarly beneficial after~     total knee arthroplasty (TKA) surgery needs to be examined. Therefore the investigators~     questioned whether wearing a brace that has previously been shown to increase strength and~     function in OA patients can also increase strength and function in patients after TKA.~   "
23418|NCT03260452|"~     Based on solid preclinical results in mice and preliminary data in humans, this study aims to~     provide the proof of concept of the crucial role of the hematopoietic process occurring in~     human adipose tissue in the initiation of the inflammatory process at the origin of insulin~     resistance and type 2 diabetes (T2D). The main objective is to compare the number of~     pro-inflammatory macrophages derived from human adipose tissue hematopoietic stem cells (HSC)~     according to their origin, type 2 diabetes subjects or healthy volunteers.~   "
23419|NCT03260439|"~     After the consent of the local ethics committee and informed consent of the parents, we~     conducted a prospective randomized, double-blind study, from 30 June 2014 to 31 December~     2014, including one to eight year olds, ASA I or II and Programmed for circumcision.We~     collected 53 children in each group.~   "
23400|NCT03260686|"~     People who have had a stroke benefit from opportunities to practice the activities they need~     to re-learn. It is common practice to give patients written exercises to guide their practice~     out of therapy session. Whilst more practice is better, it is important that the activities~     are practiced accurately, to ensure that the right movement patterns are re-learned.~      The aim of this study, is to evaluate whether an intervention providing in-patients who have~     had a stroke an opportunity to use a simple video guide to help them perform their exercises~     accurately would improve clinical outcomes. Watching an activity being performed helps you to~     learn the activity more effectively. The focus of this study is arm rehabilitation.~      The participants will be adult in-patients in Leeds Teaching Hospitals Trust, and will have~     had a first time stroke that has left them with some arm weakness.~      The participants will be matched according to the severity of their weakness, then randomly~     allocated to either a treatment as usual group, or an intervention group. Those in the~     intervention group will have their exercises for their arm and hand recorded onto a tablet~     during their normal therapy session. They will then be lent the tablet for the duration of~     the trial, so they can have a visual guide to help them throughout the trial period. Ward~     staff will be shown how to use the tablet to help any participants who struggle with the~     technology.~      Measurements will be made before and after the trial period to look at ability to move the~     arm and hand, quality of movement, self-efficacy and time spent exercising. Participants and~     staff will be asked for their experiences of the intervention or normal practice.~      This is a feasibility study with an embedded process evaluation.~   "
23401|NCT03260673|"~     This study investigate the change of the corneal endothelial cells in patients with type 2~     diabetes after phacoemulsification with intraocular lens implantation.~   "
23402|NCT03260660|"~     In this research study, the investigators will compare the liver stiffness results obtained~     from the current Magnetic Resonance Imaging (MRI) method to liver stiffness results obtained~     from a method that uses faster imaging techniques.~   "
23403|NCT03260647|"~     Management of Malignant Bowel Obstruction (MBO) in Patients with Advanced Gynecological~     Cancers~   "
23404|NCT03260634|"~     Invasive fungal infections are a significant cause of morbidity and mortality in~     immunocompromised host such as prolong neutropenic patients , post transplantation patients,~     malignancies or advanced AIDS . The majority of these infections were caused by Aspergillus~     species, which the first line of treatment is antifungal agent, Voriconazole , a triazole~     antifungal drug which was approved by the Food and Drug Administration in May 2002 for the~     treatment of invasive aspergillosis and refractory infections of Scedosporium apiospermum and~     Fusarium spp. There are two forms of Voriconazole , oral and intravenous form. The~     recommendation dose is 6 mg/kg twice daily for two dosages, followed by 4 mg/kg twice daily~     in intravenous form or a loading dose of 400 mg twice daily for two doses is used (for~     individuals >40 kg), followed by 200 mg twice daily, and in individuals <40 kg the~     maintenance dose is 100 mg twice daily in oral form.~      Voriconazole has a narrow therapeutic window and nonlinear pharmacokinetic profile with wide~     inter-individual and intra-individual variability, such as age, race, genotypic variation,~     liver dysfunction, the presence of food and drug-drug interactions with CYP450 inhibitors.~     These large variations in pharmacokinetics may be associated with decreased efficacy or~     increased toxicity. Therefore , monitoring of serum trough concentrations is recommended in~     the following infections: invasive aspergillosis treatment , endophthalmitis; meningitis or~     osteoarticular infections due to Exserohilum rostratum.~      In Thai population , there are different genetic polymorphism from Caucasian ,resulting in a~     different response to the initial dose and there is limited resources in Thailand , mostly~     patients are unaccessible for Voriconazole level. Especially,in the period of starting drug,~     which is the critical period for patients ,most of them are post chemotherapy which may have~     gastrointestinal problems, mucositis , vomiting or diarrhea ,as well as receiving multiple~     concurrent medications. All of these affect drug absorption,drug level and efficacy of~     treatment. Thus, this study was designed to evaluated Voriconazole level in Thai patients in~     the first two week after administration.~      Primary question~        -  From the first collected of Voriconazole drug level , Are the invasive fungal infection~          patients in King Chulalongkorn Memorial Hospital achieved the drug level more than 60% ?~      Secondary question~        -  Which factor affecting Voriconazole through level in the first two weeks after~          administration?~      Research Design~        -  Observational Studies (Descriptive retrospective and prospective study)~      Research Methodology~      Target Population~        -  Patients received Voriconazole for treatment or prophylaxis invasive fungal infection~      Study population~        -  Patients in King Chulalongkorn Memorial hospital received Voriconazole for treatment or~          prophylaxis invasive fungal infection~      Sample size~      n= ZZ/2P(1-P) /dd~        -  n = sample size~        -  P =Incident rate~        -  From the pilot study of 15 Invasive fungal infection patients in King Chulalongkorn~          memorial hospital from February to September 2015 , 60% ( 9 of 15 patients) of the first~          collected of Voriconazole trough level achieved the therapeutic level.~      replaced P = 0.6~        -  Z = 95% confident interval = 1.96~        -  d = acceptable error = 0.10~      n = (1.96) (1.96) (0.60)(1-0.60) / (0.10)(0.10)~      n =92 , sample size = 92~      Study processing and data collection~      Data collection~        -  Collected data of patients received Voriconazole in first two weeks of treatment or~          prophylaxis invasive fungal infection in King Chulalongkorn Memorial hospital in~          2015-2017 from outpatient records , inpatient records and computer database in King~          Chulalongkorn Memorial hospital. This data included~        -  Baseline characteristics : sex, age ,weight ,BMI ,co-morbid ,personal history of smoking~          or alcohol drinking~        -  Basic laboratory investigation : complete blood count , Creatinin , liver function test~          , albumin level~        -  Gastrointestinal problems~        -  Indication of Voriconazole treatment~        -  Data of invasive fungal infection :~        -  Data of Voriconazole usage : Loading dose, Maintenance dose, Trough level , Data of drug~          adjustment, Concurrent medication used, Side effect~        -  All data was summarized and recorded in case report forms.~      Data Analysis and Statistics~      The data was analysed by computer using SPSS17 program This study used descriptive statistics~     ,describing general information, age, results, laboratory results and side effects of the~     drug in mean ,percentage or standard deviation. And used the chi-square test for analysis of~     the proportion of patients with serum drug levels within the therapeutic range.~      This study used a confidence level of 95%, p-value less than 0.05 was statistically~     significant.~   "
23405|NCT03260621|"~     Patients of the University Hospital Göttingen with echocardiographic signs for diastolic~     heart failure and indication for right heart catheterisation will undergo additional~     diagnostic testing with CMR including exercise stress for detailed evaluation of diastolic~     dysfunction and tissue characterisation correlating the results with well-established~     clinical standards.~   "
23406|NCT03260608|"~     Dementias are neurodegenerative syndromes typical of the elderly population and causing a~     high degree of disability and sick of dependence on others for care. Caregivers of patients~     with dementia, especially those belonging to the same family suffer with high overhead and is~     often affected by losses in their own health. The aim of this study is to evaluate the~     efficacy of a psychoeducation and protocol support, conducted by telephone, in aid of~     patients with dementia caregivers in specialized outpatient treatment. It will be selected~     patients in outpatient specialized care. The primary outcome is the change in Zarit Scale.~   "
23407|NCT03260595|"~     This is a Phase 1 parallel-cohort study of crisaborole ointment 2% to evaluate the skin~     irritation potential in adult Japanese healthy subjects in Cohort 1, and to evaluate the~     safety, tolerability and PK in adult Japanese subjects with mild to moderate AD in Cohort 2.~   "
23408|NCT03260582|"~     The study will assess the efficacy of a web-based application as a complement to traditional~     exercise-based cardiac rehabilitation for improvement of secondary prevention outcomes in~     post-myocardial infarction patients, compared with usual care. The hypothesis is that the~     intervention enhances patient adherence to lifestyle advice (exercise training, daily~     physical activity, healthy diet and tobacco abstinence) and medication, resulting in better~     risk factor control and prognosis as well as increased self-rated health.~   "
23409|NCT03260569|"~     This study will evaluate the changes in respiratory mechanics following traumatic brain~     injury and determine the effect of inhaled nitric oxide on gas exchange.~   "
23410|NCT03260556|"~     Study comparing pirfenidone versus placebo for patients with advanced fibrotic sarcoidosis~   "
23411|NCT03260543|"~     This study was conducted to investigate the effects of daily supplementation of fermented~     ginseng powder on improvement of Liver function.~   "
23412|NCT03260530|"~     It appears necessary to confront the reality of the contribution of technological progress in~     the creation of prostheses with the specific features of lower limb amputees. These~     contributions must be clearly identified in their different functional dimensions. This~     justifies a quantitative approach to the locomotor abilities of these patients, with regard~     to bioenergy parameters (consumption of oxygen while walking) and motor biomechanical~     parameters (quantified analysis of movement), so as to measure the real impact of the~     proposed prosthesis technology, as a complement to classical qualitative approaches.~      In this context, Dijon CHU, thanks to its Technological Investigation Platform (PIT, CIC~     1432), and the company PROTEOR established a research partnership aiming to:~        -  Refine the indications for the prescription of new products, by ensuring that they~          correspond to the profiles of the patients concerned and their true needs,~        -  Study the underlying adaptive mechanisms, and establish new recommendations for their~          use, depending on the profiles of the users,~        -  And ultimately, better evaluate, in a more rigorous and systematic manner, the~          prostheses available on the market.~      The research protocol presented in this document aims to provide a framework for part of the~     explorations that will be conducted in the context of this partnership. Lower-limb amputees~     who will be evaluated in this research will wear these prostheses (foot and/or knee~     prostheses), which bear the CE logo, and thus present all of the safety and performance~     conditions required for their use by these patients (prostheses destined for usual~     prescriptions), the objective of the study was not to evaluate the prostheses as such, but to~     explore and quantify the impact of these prostheses and their eventual modifications on the~     locomotor abilities of the patients concerned.~      The investigations will be conducted using non-invasive evaluation tools available on the PIT~     platform, with no modification in the usual management of these voluntary patients.~   "
23413|NCT03260517|"~     To evaluate the clinical safety and efficacy of a new Medtronic Coronary Drug-Coated Balloon~     Catheter in the treatment of de novo lesions, small vessel disease or In-Stent Restenosis~     with coronary lesions previously treated with drug-eluting or bare metal stents in native~     coronary arteries.~   "
23414|NCT03260504|"~     This phase I trial studies the side effects and best dose of aldesleukin when given together~     with pembrolizumab in treating patients with kidney cancer that has spread to other parts of~     the body. Aldesleukin may stimulate white blood cells to kill kidney cancer cells. Monoclonal~     antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and~     spread. Giving aldesleukin and pembrolizumab may work better in treating patients with kidney~     cancer.~   "
40309|NCT03039114|"~     The purpose of this study is to evaluate the safety and efficacy of INCB050465 when combined~     with bendamustine and obinutuzumab in subjects with relapsed or refractory follicular~     lymphoma (FL).~   "
23424|NCT03260374|"~     One of the main factors affecting the ability to maximize the full potential of a cochlear~     implant is an accurate map.The goal of mapping is to enable cochlear implant recipients to~     perceive a desired range of acoustic signals. The process includes programming of the minimum~     and the maximum stimulation levels that are based on subjective measurements of thresholds~     and the most comfortable level . The use of objective measures in the CI process has greatly~     contributed to the definition of the dynamic field, as they provide specific values that~     serve as the basis for the start of the mapping process, especially in cases of infants and~     young children. Some examples of these measures are electrically evoked stapedius reflex~     threshold , neural response telemetry , brainstem auditory evoked potential , and P300, among~     others.~   "
23425|NCT03260361|"~     Relation between hypnosis and MEOPA on algodystrophy.~   "
23426|NCT03260348|"~     The study enrolls ARDS patients in medical ICUs in 11 Hospitals in Taiwan. The epidemiology~     and long-term outcomes of the patients will be recorded.~   "
23427|NCT03260335|"~     This study aims to explore whether feedback from a physical monitoring device (electronic~     watch) to prompt patients to use an anxiety management strategy can help prevent challenging~     behaviour.~   "
23428|NCT03260322|"~     The primary purpose of this study is to evaluate the tolerability and safety profile of~     ASP8374 in participants with locally advanced (unresectable) or metastatic solid tumors. Also~     primary purpose is to characterize the pharmacokinetic profile of ASP8374 and to determine~     the recommended Phase 2 dose (RP2D) of ASP8374.~      The secondary purpose of this study is to evaluate the anti-tumor effect of ASP8374.~   "
23429|NCT03260309|"~     Success of the hip arthroplasty depends on the measures that optimize perioperative~     conditions.It is planned to evaluate semi-closed loop system in the hip arthroplasty surgery.~   "
23430|NCT03260296|"~     Smartphones have become a part of our daily life, the number of people using smartphones is~     increasing day after day. Easy access to internet is the main advantage of smartphones in~     comparison to traditional mobile phones, so they are considered as handheld convenient~     substitutes to computers. People use smartphones for many different purposes such as~     communication, entertainment, browsing for information, education or business facilitation.~     Unfortunately the excessive use of smartphones makes people 'addicted' to that type of~     technology. Past research has shown that older people have less positive attitudes towards a~     variety of technologies and they are less likely than younger people to embrace new~     technology, so It seems that the problem of smartphones addiction is most likely to affect~     young people who are fascinated with new technologies.~   "
23431|NCT03260283|"~     The aim of this study is to assess the efficacy of subarachnoid anesthesia with low dose of~     pethidine (0.4mgkg-1) compared to administration of ropivacaine and fentanyl which is~     nowadays the common practice.~   "
23432|NCT03260270|"~     Venous thromboembolism (VTE) is a serious preventable complication of gynecological surgery.~     High incidence of silent VTE before surgery seems attributable to the high incidence of VTE~     after surgery in ovarian cancer .so the aim of work is to detect silent venous thrombosis in~     gynecological patients suffering from pelvic masses using different imaging modalities .~   "
23433|NCT03260257|"~     Schizophrenia affects 2.4 million Americans and causes significant individual and societal~     costs. Cognitive deficits including poor working memory arise early in the course of illness,~     account for poor long-term outcomes and have been difficult to treat with available~     treatments. The investigators are proposing to develop a novel, computer-based brain training~     to improve working memory in schizophrenia patients, which, if successful could have~     significant personal, societal, and economic impact.~   "
23434|NCT03260244|"~     This document is a clinical investigation plan (CIP) for the EnSite Precision Observational~     Study.~      This clinical study is intended to quantify and characterize the usage of the EnSite~     Precision™ Cardiac Mapping System (Software version 2.0.1 or higher) in a real-world~     environment. This study will be conducted in patients who are indicated for a cardiac~     electrophysiological (EP) mapping and radio frequency ablation procedure using a~     three-dimensional system.~   "
23435|NCT03260231|"~     Recent literature data suggest beneficial effects of dietary fats in patients with cancers,~     in particular polyunsaturated fatty acids (PUFAs). Milled mix of flax, sesame and pumpkin~     seeds provides a high amount of PUFAs and a desirable n-6/n-3 PUFAs ratio.~   "
23436|NCT03260218|"~     The incidence of post-operative delirium in the South-east Asian population is not known.~     Through a prospective, single centre, observational study, the investigators aim to~     characterize the incidence and risk factors of delirium in older adults undergoing elective~     total joint arthroplasties (TJA). The study will recruit eligible patients (65 - 90 years old~     undergoing elective TJA), with a targeted sample size of 500. Patients will be screened for~     dementia and Confusion Assessment Method (CAM) scores obtained pre and post operatively.~     Other data such as preoperative Charlson comorbidity index (CCI), post op complications using~     Post operative Morbidity Survey (POMS), pain scores, readmission rates and length of hospital~     stay (LOS), functional and health-related quality-of-life (HRQoL) will also be collected and~     analysed.~   "
23437|NCT03260205|"~     The purpose of this study is to determine if an investigational treatment is effective in~     improving the total score on the ADHD-RS-IV Preschool Version in children 4-5 years old~     diagnosed with ADHD.~   "
23438|NCT03260192|"~     Investigators aim to investigate whether circulating tumor DNA is a sensitive marker to~     evaluate patients' response to neoadjuvant chemotherapy~   "
23439|NCT03260179|"~     This project intends to make a study of personalized medicine evaluation system establishment~     for liver cancer, gastric cancer and nasopharynx cancer to provide strong support for the~     development of Precision Medicine and personalized medicine for the patients of~     high-incidence-rates cancer in China.~   "
23440|NCT03260166|"~     This clinical study will test the efficacy and safety of nicotinamide for lupus-associated~     skin lesions refractory to the treatment of hydroxychloroquine plus low-dose corticosteroids~     in patients with cutaneous lupus erythematosus (CLE) or systemic lupus erythematosus (SLE).~   "
23441|NCT03260153|"~     The purpose of this study is to investigate the efficacy and safety of Deproteinised Calf~     Blood Serum Injection in alleviating perihematomal edema (PHE) and secondary brain injury, as~     well as neurologic deficits in patients with acute intracerebral hemorrhage (ICH).~   "
23442|NCT03260140|"~     More than a third of US Veterans who receive care through the VHA are obese, putting them at~     higher risk for multiple serious chronic health conditions. Developing evidence-based~     programs that are scalable, cost-efficient and serve a diverse Veteran population is a~     priority for the VA National Center for Health Promotion and Disease Prevention (NCP). While~     the VA's MOVE! program is an effective lifestyle intervention for obesity, its reach had been~     limited. Some Veterans may best achieve weight loss with in-person group visits or by~     internet and mobile technology-intensive programs, while others with a population-based,~     self-directed program that uses minimal technology. This trial will examine the effectiveness~     of a 12-month self-directed, low technology, and low resource lifestyle program. The program~     uses a series of DVD sessions focused on healthy eating and physical activity, and encourages~     participants to monitor their weight, diet, and physical activity for 24-months. For those~     who want to, participants will be able to work with a lifestyle coach to help meet weight and~     activity goals. The investigators hope the program will lead to modest, clinically meaningful~     weight loss and increased physical activity among obese Veterans. If successful, this trial~     may help ease the burden that obesity places on Veterans and the health care system.~   "
23443|NCT03260127|"~     This study focuses on helping Iraq and Afghanistan Veterans with posttraumatic stress~     disorder (PTSD) benefit fully from therapy by first enhancing their thinking abilities. PTSD~     has been associated with thinking problems, including difficulty planning/organizing,~     thinking flexibly, and inhibiting distracting emotional information. There is some evidence~     that computerized training programs are helpful for improving thinking. Therefore, this study~     tests whether computerized cognitive training will in fact improve individuals' thinking~     abilities and if this will in turn improve PTSD treatment outcomes and lead to more~     individuals completing treatment and showing greater improvements in emotional symptoms and~     quality of life than standard therapy (when paired with a word training condition).~   "
23444|NCT03260114|"~     Physical activity is one of the key strategies used by public health agencies to combat the~     growing burden of obesity and non-communicable diseases. Adults around the world are~     recommended to engage in at least 150 minutes of moderate or 75 minutes of vigorous intensity~     activity per week, or a combination of moderate or vigorous activity that results in~     approximately the same total energy expenditure. However, majority of the population does not~     meet the physical activity recommendation. As barriers to physical activity, people mostly~     cite lack of time, self-motivation and confidence in the ability to be physically active.~     Cardiac Exercise Research Group (CERG) at Faculty of Medicine and Health Sciences at~     Norwegian University of Science and Technology recently developed Personal Activity~     Intelligence (PAI). PAI is a result of research based on the HUNT study where more than 60~     000 individuals has been monitored over a period of more than 20 years. The goal is to make~     PAI the new world standard of activity tracking. PAI is an individual metric that makes sense~     of measured heart rate data, and significantly reduces the risk of lifestyle related~     diseases.~      The purpose of the study is to obtain new knowledge about how the use of PAI is related to~     body weight.~   "
23445|NCT03260101|"~     This is a non-interventional, long-term follow-up study in subjects who received ApoGraft in~     study ApoGraft-01. Up to 12 subjects who completed ApoGraft-01 study will be offered to~     participate in this follow-up study.~      Subjects who completed ApoGraft-01 study and have signed informed consent for this follow-up~     study will be eligible to enroll. Subject will attend in-clinic visits up to 2 years post~     transplantation, and will undergo the following evaluations: acute and chronic graft versus~     host disease (GvHD) assessments, survival status (overall, relapse-free), disease status~     (disease relapse/recurrence), physical examination, safety laboratory and concomitant~     medication use.~   "
23446|NCT03260088|"~     Pleural effusion is an accumulation of fluid between the tissue layers that line the lungs~     and chest cavity. It has an estimated prevalence of 320 per 100,000 people in industrialized~     countries. The cause of the pleural effusion remains unclear in a substantial percentage of~     patients with persistently exudative effusions.~   "
23447|NCT03260075|"~     The aim of this study is to explore the relationship between ward cats and patient~     satisfaction and stations atmosphere in patients with substance abuse, depression and~     psychosis. Moreover, we wanted to investigate the patients perception of the ward cats and~     the relationship between station atmosphere perceived by the employees working wards with and~     without cat at UKP Basel.~   "
23448|NCT03260062|"~     The purpose of this research study is to develop and evaluate a parent training program,~     which aims to improve language. The study is being conducted to see if teaching parents~     positive parenting techniques and behavior strategies will improve the rate of language~     development in children with cochlear implants when compared to standard speech therapy~     (e.g., auditory-verbal therapy).~   "
23449|NCT03260049|"~     The records of patients who were diagnosed with ARN between April 2010 and February 2017 were~     analyzed.A retrospective review of the treatment options and outcomes of the these patients~     was performed.~   "
23450|NCT03260036|"~     The aim of the project is to investigate the metabolic regulation of the hepatic urea~     nitrogen handling and various cognitive functions measured by psychometric and~     neurophysiological tests before and after bariatric surgery in patients with non-alcoholic~     fatty liver disease (NAFLD).~   "
23451|NCT03260023|"~     The study will consist of two parts :~      In the phase Ib part: safety will be assessed in consecutive cohorts of 3 to 6 patients at~     increasing doses of TG4001 in combination with avelumab according to a 3+3 design. There will~     be no intra-patient dose escalation.~      In the phase II part, evaluation of efficacy and further evaluation of safety of the~     combination of TG4001 and avelumab will be performed in a single arm cohort of patients with~     HPV-16 positive oropharyngeal SCCHN.~      In both parts, tumor response will be evaluated on local assessment using RECIST 1.1.~      All patients will be followed up until disease progression or death due to any cause or the~     date of data cut-off, whichever occurs first.~   "
23452|NCT03260010|"~     The PROOF Study is an open prospective interventional non-randomized study which aim is to~     determine the outcome / effect and safety of fosfomycin in patients with hip, knee or~     shoulder PJI.~   "
23453|NCT03259997|"~     Efficacy of probiotics on physical performance~   "
23481|NCT03259620|"~     To evaluate the efficacy and safety of six (6) weeks of once daily application of Furosemide~     Topical Gel 0.125% (CLS006) compared to vehicle in subjects ≥ 2 years of age with nongenital~     cutaneous common warts (verruca vulgaris).~   "
23455|NCT03259971|"~     Pediatric movement disorders comprise of a large number of different neurological diseases~     including Rett syndrome (RTT) and Tourette syndrome. Studies in the literature as well as our~     preliminary reports showed that Rett syndrome and Tourette syndrome/Tic disorders are~     associated with a dysbiosis of the gut microbiota compared to normal control. Probiotic~     Lactobacillus plantarum PS128 is a diet supplement that available for human consumption.~     Probiotic Lactobacillus plantarum PS128 had showed psychotropic effects such as ameliorate~     anxiety- and depression-like behaviors as well as altered the level of neurotransmitters such~     as dopamine in the brain in animal models, which might be through microbiota-gut-brain axis.~     Therefore, the purpose of this study is to access the possible neurobehavior effects of~     Probiotic Lactobacillus plantarum PS128 in Rett syndrome and Tic disorders/Tourette syndrome.~   "
23456|NCT03259958|"~     A study to assess the steady-state bioequivalence of once-weekly Corplex™ Donepezil 10 mg~     Transdermal Delivery System (TDS) compared to daily administration of Aricept®~   "
23457|NCT03259945|"~     The incidence of aortic valve disease is increasing steadily because of the ageing of the~     population. At a certain stage, replacement of the aortic valve improves symptoms and thus~     the quality of life of patients.~      Surgical aortic valve replacement is the  gold standard . The procedure involves stopping~     the heart and setting up cardiopulmonary bypass (CPB) to ensure the oxygenation of tissues.~      The reference technique consists in suturing a prosthetic valve to the aortic annulus so as~     to restore normal function. This technique has very good results in the long term. The~     elective approach is sternotomy, which has certain drawbacks: post-operative pain, risk of~     infection, psychological trauma of a major incision. In recent years an alternative approach,~     right minithoracotomy, has been proposed. The drawback to this approach is that it increases~     aortic cross-clamp time and CPB time.~      More recently, new prosthetic valves, so-called sutureless or rapid deployment valves~     have become available. The main advantage of these valves is that they are easy to implant,~     as they do not require or need just a few sutures. As a result heart-arrest time is shorter,~     post-operative inflammatory syndrome is less frequent and transfusion needs are reduced.~      However, these valves have a metallic stent to fix the valve in place by pressing against the~     aortic annulus, which may give rise to intra-cardiac conduction disorders. Yet, very few~     studies have been conducted on this subject.~      The investigators wish to evaluate these conduction disorders in a cohort of patients~     operated on in this Department with this sutureless or rapid deployment valve technique.~   "
23458|NCT03259932|"~     After a minor stroke, patients frequently report complaints such as fatigue and difficulty~     with certain everyday motor tasks, leading to a marked deterioration in their quality of~     life. The aim of this study is to show that the implementation of a personalised physical~     activity programme, starting 1 month after the hospitalisation for minor stroke,~     significantly decreases the frequency of fatigue in these patients, in comparison with usual~     management in real life..~   "
23459|NCT03259919|"~     To investigate the effect of metformin on pregnancy complications and pregnancy outcome in~     the II. and III. trimester of pregnancy in women with polycystic ovary syndrome.~   "
23460|NCT03259906|"~     For les intra-articular fractures, plate osteosynthesis is the indicated technique. Despite~     the absence of consensus, in recent years, the use of open reduction associated with internal~     plate fixation has considerably developed. Indeed, this therapeutic option allows a more~     anatomical reduction and stable fixation.~      First-generation posterior plates presented complications related to the size of the plate,~     notably tendon lesions. Over the last ten years, a new generation of thinner anterior plates~     has reduced these complications.~      In the literature, few studies have compared these two techniques in terms of functional and~     radiological outcomes. The hypothesis of this research is that osteosynthesis using a~     posterior plate is more effective than that with an anterior plate in terms of functional~     recovery in patients older than 60 years.~   "
23461|NCT03259893|"~     Atrial fibrillation (AF) is the most common arrhythmia affecting over 3 million Americans and~     about 33.5 million individuals globally. The lifetime risk of developing AF is 1 in 4 for~     adults over age 40 years. AF is associated with a major medical and socioeconomic burden~     including high cost, increased risk of stroke, heart failure, dementia, myocardial~     infarction, and death. Numerous studies have demonstrated that modifiable risk factors~     including hypertension, obesity, sleep apnea, diabetes, and sedentary lifestyle predict the~     development of AF.~      Recent studies have reported that secondary prevention interventions through aggressive risk~     factor modification can reduce the burden of AF. Structured, physician and nursing-led~     interdisciplinary AF programs have been shown to improve patient adherence to guideline~     recommendations and improve long term prognosis. Previous data, however, are derived mainly~     from white European and Australian cohorts and it is unclear whether such interventions can~     be effectively implemented in a racially diverse, safety net hospital in the U.S.~      This study is a randomized hybrid implementation-effectiveness study designed to investigate~     feasibility and effectiveness of an evidence-based innovative AF program, focusing on risk~     factor modification and AF education in a racially mixed population receiving care in a~     safety net hospital.~   "
23462|NCT03259880|"~     Acute pancreatitis (AP) is rapid-onset inflammation of the pancreas that varies in severity~     from a self-limiting mild illness to rapidly progressive multiple organ failure. Statistics~     suggest that 10-20% of patients with AP develop severe AP (SAP),1 which usually has an~     unfavourable disease progression and is associated with a poor prognosis.~      The two most common and important causes of acute pancreatitis are gallstones (40-70%) and~     alcohol (25-35%) Gallstone pancreatitis is usually due to an obstructing stone in the~     pancreatic duct near the sphincter of Oddi . In alcohol-related pancreatitis, it is believed~     that the acinar cells of the pancreas are susceptible to damage by ethanol and underlie the~     etiology of the disease . Another common cause, iatrogenic pancreatitis, may occur after~     endoscopic retrograde cholangiopancreatography (ERCP) in up to 5% of patients. Other~     etiologies of acute pancreatitis include medications, infections, trauma, hereditary,~     hypertriglyceridemia and autoimmune disease.~   "
23463|NCT03259867|"~     This is a single center, open-label phase IIA study that investigates the preliminary~     efficacy of TATE treatment of liver cancer followed by a PD-1 checkpoint inhibitor (either~     nivolumab or pembrolizumab). At least two cohorts will be enrolled, one for patients with~     hepatocellular carcinoma (HCC) and the other with metastatic colorectal cancer (mCRC).~   "
23466|NCT03259828|"~     Radiotherapy is used in cancer treatment to eradicate microscopic cancer cells to lower the~     risk of recurrence. The radiotherapy plan must account for organ movement inside the body to~     ascertain adequate dose is delivered to the target. Knowledge of the magnitude is crucial to~     radiotherapy treatment planning. This study aims to quantify the movement of the sigmoid~     colon between different fractions of radiotherapy treatment (interfraction motion) and within~     the same fraction (intrafraction motion). This knowledge will help us determine the optimal~     margin to use in radiotherapy treatment planning.~   "
23467|NCT03259815|"~     There has recently been renewed interest in the measurement of post percutaneous coronary~     intervention (PCI) Fractional Flow Reserve (FFR). Previous studies have suggested that~     post-PCI FFR values ≥ 0.90 are associated with better clinical outcomes for patients but the~     available data suggest that despite angiographically satisfactory results, this is actually~     achieved in less than 40% of cases.~      The main mechanisms for sub-optimal post-PCI FFR measurements have been proposed to be stent~     underexpansion, unmasking of a second lesion in the target vessel post PCI, residual diffuse~     disease in the untreated segments and pressure drift (a technical artifact of pressure wire~     technology).~      Using post-PCI FFR to guide stent optimisation and/or further intervention in the target~     vessel has been shown to increase the frequency of achieving optimal post-PCI FFR results~     (and therefore presumably better clinical outcomes). However, there are additional costs~     involved in the routine use of post-PCI FFR and it is not clear just how often it is even~     possible to increase the initial post-PCI FFR to ≥ 0.90. This uncertainty means that it is~     currently difficult to either recommend the routine use of post-PCI FFR or justify its cost.~      The investigators propose a prospective study to assess the feasibility of achieving post-PCI~     FFR ≥ 0.90 during standard PCI procedures in consecutive patients. The study would also~     attempt to elucidate the mechanisms for sub-optimal FFR results when they occur. The~     investigators anticipate using the data from this developmental study to support a subsequent~     funding application for a definitive phase 3 study of the impact of FFR targeted PCI on~     clinical outcomes.~   "
23468|NCT03259789|"~     The purpose of this study is to investigate the effect of bexagliflozin compared to placebo~     as an add-on therapy to metformin in lowering hemoglobin A1c (HbA1c) levels in subjects with~     type 2 diabetes mellitus (T2DM).~   "
23469|NCT03259776|"~     Since 2011, people who have had a serious accident in England are no longer looked after at~     the hospital nearest to them. Instead, they are cared for at a specialist hospital called the~     regional major trauma centre. This is so that they can get the best possible care from~     specialist professionals.~      St George's is the regional major trauma centre for the 2.6 million people living in South~     West London and Surrey County. This area stretches about 40 miles across.~      About one fifth of major trauma patients who come to St George's live more than one hour's~     journey away. Their visitors often travel a similar distance or even further. Family members~     and friends play an important part during the patient's stay. It is important to support~     visitors.~      The aim of this study is to describe the experiences of visitors whose family member or~     friend has been admitted to the major trauma intensive care unit at St George's. In~     particular, the aim is to describe the experiences of visitors who travel from far.~      First, ten visitors will be interviewed to find out more about their experiences. From these~     data, a survey questionnaire will then be developed and approximately 150 visitors who have~     been to St George's in recent months will be surveyed. This will give in-depth insights to~     understanding peoples' experiences of visiting at St George's, and what people thought was~     going well and things that could be better. The study will end with a service improvement~     workshop with representatives from the team at St George's and visitors. Study findings will~     be discussed and decisions on what should be improved will be made.~      This study is being funded by St George's Hospital Charity. The study runs from August 2017~     to October 2018.~   "
23470|NCT03259763|"~     Gastric outlet obstruction (GOO) is a common complication of luminal malignancies which is~     associated with substantial morbidity. Palliation of GOO has traditionally been through the~     surgical bypass of the obstructed lumen by creating an opening between the stomach and small~     intestine. However, In recent years, a less invasive approach, i.e. endoscopic stenting, has~     gained wide acceptance to treat unresectable malignant gastric outlet obstruction. In this~     study, the investigators are going to compare the safety and efficacy of the two different~     endoscopic techniques including Endoscopic ultrasonography-guided gastroenterostomy (EUS-GE)~     and enteral stenting (ES).~   "
23471|NCT03259750|"~     Sport activity induces a relevant risk for lower extremities especially ankle and foot~     structures. Athletes who participate in basketball, volleyball and soccer are predisposed.~     Self-reported outcome instruments have been used by clinicians to assess the treatment~     interventions effectiveness directed at patients with pathologies and identify impairments,~     disabilities and quality of life. The assessment of musculoskeletal injuries can be problem~     without clinical, radiological examination and on scores from patient-based questionnaires.~     The information from these questionnaires provides us good evidence if there is not~     interpretation of obtained scores. The Foot and Ankle Ability Measure (FAAM) is a~     self-reported outcome instrument for patients with foot and ankle disorders available in~     English, German, and French. The FAAM has a sports subscale and activity of daily living~     (ADL) subscale that can assess the activities that requires higher level. The aim of this~     study is to translate the FAAM into Turkish language, perform a cross-cultural adaptation,~     and investigate the reliability, validity of the translated version in athletic population~   "
23472|NCT03259737|"~     The intention is to study presumed changes in daily practice, probably due to New Guidelines~     concerning stroke patients. The impression is more frequent measurements of blood pressure,~     serum glucose, troponin and supplementary computer tomography or magnetic resonance imaging.~   "
23482|NCT03259607|"~     This is a research study to verify the same effectiveness and safety profile for the test~     products, nicotine 2 mg gum and nicotine 4 mg gum, as for the already approved products,~     Nicorette Mint 2 mg gum and Nicorette Mint 4 mg gum (reference products), in a standardized~     mode. This verification is done in a so-called bioequivalence study, which means that the~     same amount of the same active substance (nicotine), in the same dosage form, for the same~     route of administration, and meeting the same or comparable standards is performed.~      During the study visits, blood samples will be drawn to measure the level of the substance in~     the blood to verify that the two test products are comparable to the reference products.~      Tolerability of the treatments will be evaluated based on reported and observed adverse~     events.~   "
23473|NCT03259724|"~     Purpose of Study (The Effect of Non-Viscous Fibre Supplementation on Glycemic Control (NVFS &~     GC) in Individuals with Diabetes Mellitus.~      Regardless of the remarkable advancement in pharmacotherapy, diabetes mellitus remains a~     major concern with more than 300 millions living with its complications including CVD.~     Nutrition is a cornerstone in diabetes management, and increasing total dietary fibre have~     been shown to decrease HbA1c, fasting glucose, fasting insulin, fructosamine, and HOMA-IR.~     However, the main underlying mechanism is still not fully understood, and the specific type~     and proportion of fibre supplementation to be recommended for such individuals is still~     controversial.~      Currently, the available findings/ results from small RCTs are inconsistent. The systematic~     review method depends on combining data from many small studies in order a pooled estimate of~     the pooled effect. The purpose of this study is to conduct a systematic review and~     meta-analysis of randomized controlled trials (RCTs) assessing the effect of non-viscous~     fibre supplementation on fasting glucose and insulin in individuals with diabetes mellitus.~     We hope the findings of this study will play a role in developing the nutritional guidelines~     for individuals with diabetes mellitus.~   "
23474|NCT03259711|"~     Selective estrogen receptor modulators and aromatase inhibitors for the treatment of breast~     cancer seems to have an impact on the cardio-vascular system. This study investigates reports~     of cardiovascular toxicities for treatment including Anatomical Therapeutic Chemical (ATC)~     classification: L02 in the European pharmacovigilance database, Eudravigilance.~   "
23475|NCT03259698|"~     Despite decades of traditional prevention efforts based on behavior change and condom use,~     Ontario has seen over 700 new HIV infections annually over the past 10 years. Post-exposure~     prophylaxis (PEP) is one such approach, in which uninfected persons use 28 days of~     antiretroviral medications (ARVs) shortly after an HIV exposure to minimize the risk of~     acquiring HIV. PEP is highly efficacious, is considered a standard of care intervention based~     on medical and ethical grounds, and is supported by treatment guidelines. Yet several~     implementation challenges have limited its clinical and public health impact in Ontario,~     where no formal PEP policy exists. Our proposal seeks to optimize two aspects of delivering~     PEP for sexual exposures (nPEP). Results will inform the development of a standardized~     approach to nPEP both province-wide and elsewhere.~      Thus study has pragmatic, multicenter randomized controlled trial using a 2x2 factorial~     design to determine whether the proportion of nPEP patients that successfully complete~     follow-up:~        1. is higher among those receiving mobile phone-based text messaging support than among~          those receiving standard care; and~        2. is non-inferior among those receiving care from a sexual health clinic nurse compared to~          those receiving hospital-based physician care.~      The prospective, randomized, non-blinded, 2x2 factorial trial that will enroll 358 study~     participants in Toronto and Ottawa. In Intervention A, we will randomize half of study~     participants to a text messaging support service ('WelTel'), in which a trained,~     community-based research staff person provides standardized weekly 'check-in' messages during~     their 12-week course of PEP follow-up. The other half will receive standard care, which does~     not include any form of active outreach or reminders outside of scheduled appointments. In~     Intervention B, we will randomize half of participants to receive nurse-led care for PEP~     follow-up at a local sexual health clinic; the other half will receive standard care by a~     hospital-based ID physician. The specific activities for each follow-up visit will be clearly~     defined in a medical directive. In keeping with Ontario legislation on medical directives,~     nurses will review cases with their authorizing physician or nurse practitioner on a routine~     basis.~   "
23476|NCT03259685|"~     Increasing evidence suggest that artificial sweeteners such as saccharin, aspartame and~     sucralose may not be as metabolically safe as they first appeared, and it has been proposed~     that their consumption may be linked to important disturbances in the gut microbiome. Some in~     vitro and in vivo studies suggest that the recently approved sugar substitute Stevia (eg.~     steviol glycosides) can also influence intestinal homeostasis. However, it is not clear~     whether this natural non-nutritive sweetener (NNS) could also cause metabolic and microbiome~     disturbances as proposed for their synthetic counterparts. In fact, steviol glycosides may~     even have a beneficial impact on glucose homeostasis and lipid metabolism possibly through a~     positive action on intestinal health and gut microbiome, but this has yet to be~     experimentally tested in a rigorous study.~      The main objective of this project is to evaluate whether steviol glycosides sweetened~     beverages (SGSB) or aspartame/acesulfame K sweetened beverages (AASB) exert beneficial,~     neutral or detrimental effects on metabolic health of regular consumers of sugar-sweetened~     beverages (SSBs), and whether modulation of the gut microbiome is involved in the resulting~     impact of these NNSs on metabolic health.~      As chronic overconsumption of SSBs is clearly associated with an increased cardiometabolic~     risk, this study will be the first to determine the metabolic impact of replacing SSBs by~     potentially healthier alternatives such as the increasingly popular stevia-based soft~     drinks and aspartame-based soft drinks. The investigators will further investigate whether~     these NNS can cause pernicious effects on intestinal health and the gut microbiome. It is a~     crucial concern since the importance of this unsuspected key organ has been ignored for too~     long and its important implication in many chronic societal diseases has just been~     discovered.~      Results of this study could have a direct influence on health, nutrition and even~     agricultural policies as well as dietary guidelines around the world. This project is also~     critically important as an increasing amount of health professionals such as physicians,~     nurses and registered dietitians seek to provide evidenced-based guidance to individuals~     looking for healthier alternatives to SSBs including stevia-based or aspartame-based soft~     drinks.~   "
23477|NCT03259672|"~     This investigation is planned to compare the incidence and severity of postoperative sore~     throat according to the use of sevoflurane or desflurane.~   "
23478|NCT03259659|"~     1. To prove that patients with ulcerative proctitis and proctosigmoiditis have impaired~          autonomic functions, i.e. increased sympathetic activity and/or reduced vagal tone.~        2. To demonstrate inflammatory cytokine imbalance, i.e., increased pro-inflammatory~          cytokines. Presence of these abnormalities would make patients with ulcerative proctitis~          and proctosigmoiditis good candidates for future sacral nerve stimulation therapy.~   "
23479|NCT03259646|"~     Violence against women is a major public health threat that carries significant consequences~     for women's health. Moreover, women experiencing intimate partner violence (IPV) and sexual~     assault (SA) are more likely than non-abused women to seek certain forms of health services,~     such as for sexually transmitted infections, chronic pain and illnesses, depression and/or~     pregnancy-related concerns. As a result, the health sector is an ideal setting to identify~     and support survivors. The U.S. Institute of Medicine has identified the health care system,~     including the public health infrastructure, as key for identification of and support for~     survivors of violence, as well as for violence prevention. While some evidence-based models~     exist, no current national consensus has been reached on scalable best practices in screening~     and brief counseling for IPV/SA.~      This multi-level intervention includes integrating into the clinic setting IPV/SA screening,~     universal education, trauma informed counseling, warm referrals (e.g. provider/staff contact~     advocacy program with survivor) to local IPV/SA advocacy agencies, and access to the~     evidence-based myPlan safety decision aid app. The evaluation, using a cluster randomized~     trial design, will measure longitudinal outcomes (over 6 months) of patient self-efficacy,~     health and safety outcomes, as well as participant and provider perceptions of the~     intervention and clinic level changes in primary and reproductive health clinics in four~     states (Arizona, Massachusetts, Pennsylvania and West Virginia) to achieve the following~     aims:~      Aim 1. Evaluate the effectiveness of an evidence-based screening, universal education and~     trauma-informed counseling with tailored safety action plan and referrals to partner IPV/SA~     programs compared to standard practice, on survivor health and safety outcomes over a~     cumulative period of six months.~      Aim 2. Examine longitudinal changes in clinic-level screening, universal education, trauma~     informed counseling, safety action plans and referrals to on-site and/or partner IPV/SA~     programs and improved standards for documentation through the electronic health record (EHR)~     and continuous quality measurement and reporting.~   "
23480|NCT03259633|"~     This will be an open-label, single-arm, multicenter intermediate access protocol which~     provides treatment access to selumetinib for eligible patients with neurofibromatosis type 1~     (NF1) who have inoperable, progressive/symptomatic plexiform neurofibromas (PN) without any~     alternative therapeutic options. All patients will continue to receive drug while they are~     deriving clinical benefit .~      Approximately 50 patients in the US will be treated as part of this protocol~   "
23485|NCT03259568|"~     This project investigates the effects of repetitive transcranial magnetic stimulation (rTMS)~     on neural circuits as a function of spatiotemporal parameters and brain state in order to~     better understand why the method works and how to improve its efficacy. Leveraging our~     expertise in application of TMS methodology during concurrent single neuron recording~     techniques in non-human primates and imaging and scalp potential techniques in humans (fMRI~     and EEG), the investigators aim to resolve three interlocking problems in the design and~     application of rTMS: stimulation frequency, spatial targeting, and interactions with brain~     state.~   "
23486|NCT03259555|"~     To Demonstrate the Efficacy of Brexpiprazole for the Acute Treatment of Manic Episodes, With~     or Without Mixed Features, in Subjects with a Diagnosis of Bipolar I Disorder~   "
23487|NCT03259542|"~     This is a Phase 1, single-center, fixed-sequence, open label, drug-drug interaction study of~     the effect of multiple daily doses of oral itraconazole 200 mg, a strong inhibitor of CYP3A,~     given with mifepristone 900 mg QD, in healthy male subjects, where all drug administrations~     are given after a meal.~   "
23488|NCT03259529|"~     Despite the current advances in clinical oncology, the prognosis of patients with resistant~     diffuse large B cell lymphoma or relapse after high dose chemotherapy is dismal. Therefore~     there is a need for the introduction of novel treatment regimens. This phase I/II trial~     evaluates the safety and efficacy of combination bendamustine, gemcitabine, nivolumab and~     rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma. The safety~     of combination treatment will be evaluated with the determination of recommended dose~     schedule prior to expansion of enrollment to evaluate the antitumor activity of bendamustine,~     gemcitabine, rituximab, and nivolumab.~   "
23489|NCT03259516|"~     There is evidence of involvement of checkpoint pathways, including PD-1, in the pathogenesis~     and resistance of myelodysplastic syndrome (MDS). However monotherapy with checkpoint~     inhibitors was ineffective in a number of studies, indicating the presence of several~     mechanisms of resistance. This pilot study evaluates the safety and preliminary efficacy of~     nivolumab combination with currently existing treatments in MDS patients who failed at least~     one line of therapy. The study evaluates if there is a combination which induces objective~     responses.~   "
23490|NCT03259503|"~     The goal of this clinical research study is to learn about the safety and effectiveness of~     the combination of olaparib and high-dose chemotherapy (vorinostat, gemcitabine, busulfan,~     and melphalan, either with or without rituximab) in patients who have non-Hodgkin's or~     Hodgkin's lymphoma and are receiving an autologous stem cell transplant.~      This is an investigational study. Olaparib is FDA approved and commercially available for the~     treatment of ovarian cancer. Vorinostat is FDA approved and commercially available for the~     treatment of lymphoma. Melphalan is FDA approved and commercially available for the treatment~     of myeloma. Busulfan is FDA approved and commercially available for the treatment of~     leukemia. Gemcitabine is FDA approved and commercially available for the treatment of~     lymphoma, breast cancer, and lung cancer. Rituximab is FDA approved and commercially~     available for the treatment of non-Hodgkin's lymphoma.~      The use of these study drugs in combination to treat non-Hodgkin's or Hodgkin's lymphoma is~     investigational. The study doctor can explain how the study drugs are designed to work.~      Up to 30 participants will be enrolled in this study. All will take part at MD Anderson.~   "
23491|NCT03259490|"~     To establish the bioequivalence of one fixed dose combination (FDC) tablet of~     empagliflozin/linagliptin/metformin extended release (XR) versus the free combination of~     empagliflozin tablet, linagliptin tablet, and metformin XR tablets administered as a single~     dose under fed conditions~   "
23492|NCT03259477|"~     Renal functional reserve may be better in patients with clinical T1 renal cell carcinoma(RCC)~     undergoing laparoscopic partial nephrectomy with precise segmental renal artery clamping than~     those with complete renal arterial clamping.~   "
23493|NCT03259464|"~     The primary objective of this trial is to investigate the safety and tolerability of BI~     685509 in healthy male subjects following oral administration of multiple rising doses.~      Secondary objectives are the exploration of the pharmacokinetics (PK) and pharmacodynamics~     (PD) of BI 685509 in healthy Chinese and Japanese subjects.~   "
23494|NCT03259451|"~     A retrospective, monocentric, observational, descriptive, open study of a cohort of 149~     patients from January 2014 to December 2015~   "
23495|NCT03259438|"~     This parallel, randomized, non-inferiority trial will examine whether a ten week qigong~     intervention is not inferior to a ten week exercise-nutrition comparison group in reducing~     fatigue in cancer survivors. To build a more mechanistic understanding of physiological~     changes associated with fatigue reduction, it will secondly collect several different types~     of data to build an integrative brain-body model of vigor in cancer survivorship including:~        1. data related to neural correlates of body awareness: cortical EEG data measuring each~          subject's ability to use attention to control neurons in primary somatosensory cortex~          (replication of Kerr et al 2011 study in mindfulness), and resting state fMRI measures~          of insular connectivity with nodes of the default mode network and salience network~        2. data related to inflammation measured via inflammatory cytokines (e.g., interleukin-6~          and tnf-alpha)~        3. data related to cardiorespiratory functioning including cardiac impedance (ICG) and~          mechanical lung function~        4. data related to parasympathetic and sympathetic signaling between the nervous system and~          the rest of the periphery.~   "
23496|NCT03259425|"~     This is a single-arm, open label, Phase II study evaluating the safety and efficacy of~     neoadjuvant Nivolumab and HF10 in resectable stage IIIB, IIIC, and IVM1a melanoma.~   "
23497|NCT03259412|"~     The aim of the study is to determine whether fish oil (specifically omega-3 long chain~     polyunsaturated fatty acids [EPA-DHA]) supplementation can enhance eccentric resistance~     exercise performance when combined with a resistance exercise training study. The~     investigators aim to establish the potential mechanisms that might mediate performance~     changes at a cellular level.~   "
23498|NCT03259399|"~     Dry cough is the most common adverse reaction of angiotensin converting enzyme, including~     enalapril, in Chinese population. Clinical observations suggest that the incidence of~     ACEI-induced dry cough is different between Chinese and other racial groups, however, there~     is still lack of research data in Chinese. In this study, we will investigate whether there~     are specific genotypes which may predict the incidence of enalapril-induced dry cough in~     Chinese so as to provide a basis for developing guidelines on precise medication in enalapril~     therapy apply to Chinese population.~   "
23500|NCT03259373|"~     The purpose of this study is to use a decentralized claims database to determine whether~     education on stroke prevention in atrial fibrillation (AF) among AF patients and their~     providers can result in increased use of oral anticoagulants (OAC) for stroke prevention~     among those AF patients with guideline-based indications for oral anticoagulation~     (CHA₂DS₂-VASc score of 2 or greater). Specifically, the investigators will conduct a~     prospective, randomized, open-label education intervention trial to evaluate the effect of~     the early patient and provider education interventions on the proportion of patients with~     evidence of at least one OAC prescription fill (defined as one OAC dispensing or 4~     international normalized ratio [INR tests] over the course of the follow-up through the date~     on which at least 80% of eligible study participants have at least 12 months of follow-up~     time). A total of approximately 80,000 patients will be enrolled within multiple major health~     plans across the United States. The randomization will be performed by the central~     coordinating center, and the health plans will mail the educational intervention materials to~     their members and providers.~   "
23501|NCT03259360|"~     The 2-year research plan will test the Put It Out Project (POP) in a pilot randomized trial~     (N=120) compared to TSP and two historical control conditions. Participants will be young~     adults who smoke, identify as sexual or gender minorities, and use Facebook. The primary~     outcome will be biochemically verified 7-day abstinence from smoking at 3 and 6 months.~     Secondary outcomes will be a quit attempt (y/n), stage of change, and thoughts about tobacco~     abstinence at 3 and 6 mos.~   "
23502|NCT03259347|"~     The purpose of this study is to assess the effectiveness of two body acceptance programs for~     women. Participants may experience reduction of eating pathology and prevention of future~     obesity and eating disorders; may derive a sense of altruism and contribution to furthering~     understanding of a public health problem.~   "
23503|NCT03259334|"~     The purpose of this study is to evaluate the efficacy of SHP647 in inducing remission, based~     on composite score of patient-reported symptoms and centrally read endoscopy, in subjects~     with moderate to severe ulcerative colitis (UC).~   "
23504|NCT03259321|"~     The role of fishery diet and polyunsaturated fatty acids (PUFA) in the development of type 2~     diabetes (T2D) is heavily debated but evidence from large populations in China is scant. We~     aim to use data from the China Health and Nutrition Survey (CHNS) to assess the long-term~     association between fish, PUFA intake and T2D risk.~   "
23505|NCT03259308|"~     The purpose of this study is to evaluate the efficacy of SHP647 in inducing remission, based~     on composite score of patient-reported symptoms and centrally read endoscopy, in subjects~     with moderate to severe ulcerative colitis (UC).~   "
23506|NCT03259295|"~     The objective of this study is to assess the efficacy of using the Digiclamp device to remove~     achrocordons (skin tags). The hypothesis is that utilizing the device will result in low~     rates of re-occurrence, scars, scar tissue and discoloration at the site of removal.~   "
23507|NCT03259282|"~     Evaluation of the rate of achievement of serum protein electrophoresis (PPE) in diagnosis in~     a retrospective cohort of patients at Rennes University Hospital~   "
23508|NCT03259269|"~     This observational study will examine the safety and efficacy of bedaquiline and delamanid~     used (individually, not together) in routine, multidrug regimens for treatment of MDR-TB. The~     information gathered in this study will inform doctors how best to use these TB drugs in the~     future.~   "
23509|NCT03259256|"~     The purpose of this study is to determine if islet cell transplantation , is an effective~     treatment for type 1 diabetes. Study participants may receive up to three islet transplants~     and will be followed for five years to monitor blood sugar control, islet transplant~     function, and changes in quality of life.~   "
23510|NCT03259243|"~     To comparison of efficacy of Bupivacaine for relief postoperative pain in women undergoing~     laparoscopic gynecologic surgery~   "
23511|NCT03259230|"~     This observational study is designed to provide a better understanding of the potential use~     of IFNγ and IFNγ-inducible chemokines as markers of HLH disease activity and prognosis, and~     of the potential of IFNγ as a therapeutic target in M-HLH.~   "
23512|NCT03259217|"~     This study will assess the efficacy of application of stem cell in healing of chronic~     diabetic foot ulcer~   "
23513|NCT03259204|"~     Lower limb immobilization is associated with high risk of complications, i.e. venous~     thromboembolism (VTE) and failed healing. Pharmacoprophylaxis of VTE is in leg-immobilized~     patients, however, low- or non-effective and associated with adverse events. Thus, there is a~     need for novel treatments.~      This study aims to demonstrate in leg immobilized patients who have suffered an ankle~     fracture (1000 patients) or an Achilles tendon rupture (400 patients) that adjuvant~     intermittent pneumatic compression (IPC) therapy, which targets impaired vascular flow,~     compared to treatment-as-usual with plaster cast, reduces VTE incidence and improves healing.~   "
23514|NCT03259191|"~     Anti-reflux mucosectomy (ARMS) may be a new therapy for refractory gastroesophageal reflux~     disease (RGERD). The aim of the present study is to explore the safety and efficacy of ARMS.~   "
23515|NCT03259178|"~     Sports-related concussion affect 1.6 to 3.8 million people each year in the United States.~     Despite increased media attention and awareness campaigns, the exact number is difficult to~     determine due to underreporting by athletes. The types of symptoms experienced with a~     concussion depend on the area of the brain that was affected. The most frequent symptoms~     include: headaches, cognitive difficulties, dizziness, neck pain, visual disturbances,~     difficulty sleeping, and fatigue.~      Despite the availability of many treatment options, some patients continue to experience many~     symptoms - such as headaches, dizziness, visual disturbances, balance problems, sensitivity~     to light, and difficulties concentrating - that negatively affect school, work, and quality~     of life for long periods of time. All of these symptoms are similarly experienced by~     individuals with visual dysfunctions, such as the inability of the eyes to move together.~     This finding has led some to recommend a visual component in concussion management.~     Therefore, the purpose of this study is to determine whether changes in the results of 7~     binocular vision tests (BVT) over time in patients with concussion correlate with changes in~     concussion symptoms. The investigators will measure 46 concussion patients aged 18 to 30~     years with each of these tests and assess their concussion symptoms on up to four separate~     visits, which depend on when the patient's symptoms improve.~      The tests the investigators will evaluate measure: 3D vision, uniform movement of the eyes,~     ability of the eyes to adapt to a target moving towards and/or away from the eyes, quick~     movements of the eyes, natural alignment of the eyes, and double vision as a target is moved~     towards the eyes. In addition, concussion symptoms will be measured by a standardized~     concussion questionnaire (SCAT3) at each visit.~      The results of each BVT will be entered into a statistical model with the participant's~     concussion symptom score to determine if there is an association between the change in~     symptoms and the change in the results of the tests.~   "
23583|NCT03258294|"~     This clinical study is a double-blind, randomized, placebo-controlled trial to investigate~     the effects of melatonin on the sleep disturbance symptoms of Parkinson's disease patients,~     symptoms which have a significant impact on the quality of life of these patients.~   "
23516|NCT03259165|"~     Nearly 80% of acute heart failure (AHF) patients admitted to the hospital are initially~     treated in the emergency department (ED). Once admitted, within 30 days post-discharge, 27%~     of patients are re-hospitalized or die. Attempts to improve outcomes with novel therapies~     have all failed. The evidence for existing AHF therapies are poor: No currently used AHF~     treatment is known to improve outcomes. ED treatment is largely the same today as 40 years~     ago. Congestion, such as difficulty breathing, weight gain, and leg swelling, is the primary~     reason why patients present to the hospital for AHF. Treating congestion is the cornerstone~     of AHF management. Yet half of all AHF patients leave the hospital inadequately decongested.~      Although it is the investigators' belief patients are often inadequately decongested in the~     ED, it is common teaching within emergency medicine to focus on vasodilators and avoid or~     minimize diuretics, especially in those patients with elevated blood pressure. This practice~     is largely driven by retrospective analyses or small studies suggesting vasodilators are~     efficacious and IV loop diuretics may be associated with harm. The evidence base to guide~     early ED management is poor, and the AHA/ACC guidelines provide little to no guidance for ED~     treatment. This reflects the lack of high quality data, a critical unmet need that the~     investigators will address in this study.~      Using clearance of LUS B-lines as the study endpoint, the investigators will study whether a~     diuretic intense vs. nitrate intense strategy achieves better decongestion. Although nearly~     two decades old, a small study of 100 patients suggested a nitrate intense strategy led to~     better outcomes in AHF patients with pulmonary edema when compared with a diuretic intense~     strategy. The investigators aim to perform a small pilot study, in hypertensive patients (SBP~     > 140mmHg) to test such a strategy to inform a larger, more definitive multicenter randomized~     trial.~   "
23517|NCT03259152|"~     Giant cell tumor of bone (GCTb) is a primary, osteolytic, benign tumor of the bone. Surgery~     is the commonly used treatment. Discovery of RANKL and its human monoclonal antibody,~     denosumab, led to use of denosumab for treatment of GCT. The aim of this study was to~     evaluate clinical and pathological results of treatment of relapsed or refractoriness GCT~     with denosumab and to assess adverse effect profile and recurrence rate.~   "
23518|NCT03259139|"~     More American children die by accidental gun use than children in other developed countries.~     One factor that can influence children's interest in guns is exposure to media containing~     guns. The objective of this study is to test whether children who play a video game~     containing guns will handle a real gun longer and will pull the trigger more times than~     children who see the same movie without guns.~   "
23519|NCT03259126|"~     Radiation dose to interventional cardiologists performing transradial percutaneous coronary~     procedures is higher compared to those performing transfemoral exams. The radiation dose~     seems particularly high at pelvic level. We prepared an home-made protective extension of the~     leaded curtain under table that should reduce the operator exposure during interventional~     coronary procedures. The aim of the study is to evaluate the procedural efficacy of the~     protective extension on the operator radiation dose at pelvic level~   "
23520|NCT03259113|"~     Hypertrophic cardiomyopathy (HCM) is associated with sudden cardiac death and an increased~     risk of atrial fibrillation and subsequent embolic event. An insertable cardiac monitor will~     provide data on cardiac rhythm over a period of 18 months. This will provide an extended~     monitoring far longer than 24-48 hours of Holter monitoring as is currently usual care.~     Therefore, detection of arrhythmias could be used in risk stratification and decision-making~     with regard to offer an implantable defibrillator and anticoagulants.~   "
23521|NCT03259100|"~     The investigators evaluated the spatial association between, cardiovascular diseases (CVD)~     and stroke mortality rate with average ambient temperature (Ta) , and then used this~     relationship to model future temporal trends in mortality from CVD and stroke till the end of~     century (2099) using different warming scenarios across the mainland USA.~   "
23522|NCT03259087|"~     The purpose of this study is to compare plasma and urine PK parameters of MK-3866 between~     participants with impaired renal function and healthy control participants, to investigate~     the extent to which MK-3866 is removed from the plasma by hemodialysis (HD), and evaluate the~     safety and tolerability of MK-3866 in participants with impaired renal function.~   "
23523|NCT03259074|"~     The purpose of this study is to demonstrate the impact of secukinumab on progression of~     structural damage in the spine, as measured by the mSASSS in patients with AS.~   "
23524|NCT03259061|"~     The aim of this work is to evaluate the role of cephalometry &nasofibroscopy as objective~     tools in order to confirm the diagnosis based upon the clinical judgment of border line cases~     suspected to have velopharyngeal incompetence or insufficiency.~   "
23525|NCT03259048|"~     Acute abdomen can be defined as A syndrome induced by wide variety of pathological~     conditions that require emergent medical or more often surgical management [1].There are a~     plethora of causes that can lead to acute abdomen in children, they vary depending on the~     ages of the children and can be divided into diseases that can be treated with medical care~     and those in which emergency surgical intervention must be considered [2]. Ultrasonography is~     the initial choice in the diagnosis of the different causes of acute abdomen in children [3,~     4]. It is very useful as it is non-invasive, cost- effective, repetitive, with no radiation~     exposure, as good as laparoscopy, can be done even in patients with scarred abdomen [5].~   "
23526|NCT03259035|"~     The purpose of this study is to find out the effects of chemotherapy followed by less~     invasive surgery on patients and their early rectal cancer. The approach of this trial will~     be considered a success if at least 65% of participants are able to keep the rectum.~   "
23527|NCT03259022|"~     Hypothesis:~        1. Innate immunity is altered in certain patients with COPD and frequent exacerbations, a~          fact that makes them more susceptible to being infected by bacteria.~        2. The electronic nose is able to detect patterns of specific VOCs for exacerbations of~          infectious origin.~   "
23528|NCT03259009|"~     Some data have suggested a clinical survival benefit related to the reintroduction of~     anti-EGFRs therapy in patients with metastatic colorectal cancer (mCRC). Based on resistance~     mechanisms related to the development of resistant clones, the investigators could assume~     that patients who benefited most from the reintroduction of anti-EGFRs were those who,~     through interval chemotherapy, had no longer mutated RAS clone in plasma that appeared during~     the progression with the first anti-EGFR treatment. Conversely, those who did not benefit~     from this therapy were probably patients who had mutated RAS clones circulating at the time~     of reintroduction of anti-EGFRs. To support this hypothesis, investigators propose to~     evaluate the correlation between the eventual presence of RAS mutations in circulating blood~     and the efficacy of an anti-EGFR therapy reintroduction in patients with mCRC.~   "
23584|NCT03258281|"~     Pospective, single center, double-blind, randomised pharmacodynamic experimental study. The~     study will enroll 150 subjects with ASCVD on optimal statin therapy as per physician and~     Diabetes Mellitus (DM) undergoing elective Percutaneous Coronary Intervention (PCI). Eligible~     patients will be randomized for 30 day treatment to either 1) evolocumab 420 mg ; or 2)~     placebo.~   "
23529|NCT03258996|"~     The main objective is to assess whether the percentage of root coverage (%RC) achieved in the~     treatment of multiples class III recessions using the technique we have called modified~     vestibular incision subperiosteal tunnel access (mVISTA), which is a lateral approach~     subperiosteal tunnel technique, combined with a connective tissue graft is greater than that~     achieved through the coronally advance flap (CAF) technique together with a connective tissue~     graft.~   "
23530|NCT03258983|"~     Background: The plant-derived omega-3 fatty acid alpha-linolenic acid (ALA, 18:3-n-3) may~     reduce the risk of atherosclerotic cardiovascular disease, including incident myocardial~     infarction, ischemic stroke and peripheral artery disease. However, the results of previous~     studies have been inconsistent.~      Objectives: To investigate the associations between dietary intake of ALA, adipose tissue~     content of ALA, and the risk of the major atherosclerotic cardiovascular diseases incident~     myocardial infarction, ischemic stroke and subtypes, and peripheral artery disease.~      Methods: This project will be based on data from the Danish cohort study Diet, Cancer and~     Health which consisted of 57,053 men and women at recruitment between 1993 and 1997. Dietary~     intake of ALA will be assessed using a validated semiquantitative food-frequency~     questionnaire and adipose tissue content will be determined with the use of gas~     chromatography analyses of adipose tissue biopsies collected at baseline. Also, detailed~     information on lifestyle factors, medical history and anthropometri was collected at~     baseline.~      Incident cases have been identified through national registries and the diagnoses have~     previously been validated.~      Analyses of dietary intake of ALA will be analysed using a traditional cohort design, whereas~     analyses on adipose tissue content of ALA will be analysed based on a case-cohort design.~     Hazard ratioes with 95% confidence intervals will be used to describe the associations~     between the exposure variables and the outcome variables of interest.~   "
23531|NCT03258970|"~     To assess the cross-sectional and 5-year prospective association between self-reported~     vitamin C+E dietary supplementation and markers of grip strength and frailty in~     community-dwelling Swiss adults.~   "
23532|NCT03258957|"~     Necrotizing enterocolitis (NEC) is a severe inflammatory disorder of the intestine that~     primarily affects very low birth weight (<1,500 g)/very preterm infants (≤32 weeks'~     gestation); it is also the leading cause of death in the neonatal intensive care unit~     (NICU).Perhaps the best form of treatment for NEC is prevention. Mother's breast milk is best~     for preventing NEC. Breast milk contains both nutritional components (proteins, amino acids,~     fats, carbohydrates, vitamins, and minerals) and bioactive components (macrophages, T cells,~     cytokines, hormones, and growth factors) that have antimicrobial and anti-inflammatory~     properties.The current NICU breast milk feeding procedure exists as a means of ensuring that~     infants have consistent access to their mother's breast milk even if the mother is not able~     to spend time in the NICU. The process also allows for stricter quality and infection~     control, as well as computerised inventory and monitoring via electronic health~     records.However, the process deprives infants of the benefits of the cellular content of~     breast milk, including the stem cells.The primary objective of this study isto evaluate the~     feasibility and safety ofproviding very preterm infants (born at <30 weeks' gestation) with~     fresh milk (within 4 hours of expression).While we acknowledge that as a pilot the study will~     not be powered to detect a statistically significant difference, our secondary objective is~     to identify if this approach has the potential to improve infant outcomes, particularly with~     regards to the occurrence of NEC.~      Our hypothesis is that it is feasible for many mothers to provide at least 1 feed of fresh~     breast milk (<4 hours post expression per day, and is not frozen, chilled or pasteurized) and~     that this may decrease the prevalence of NEC~   "
23533|NCT03258944|"~     In several diseases in which muscle weakness is a determining factor for morbidity and~     mortality, inspiratory muscle training has been shown to be useful in improving the function~     of ventilatory muscles, delaying or minimizing the development of complications due to the~     reduction of inspiratory muscle strength.~      The breath-stacking technique emerges as an easily applicable alternative, and it can be used~     in poorly collaborative patients. The technique described in the literature aims to increase~     pulmonary volumes.~      This gain occurs with the coupling of a silicone mask on the patient's face, a unidirectional~     valve and with the expiratory branch occluded. Thus, inspirations occur sequentially in this~     medium, generating pulmonary hyperinflation and increasing the contractility power of the~     expiratory muscles, which are fundamental for coughing. This hyperinflation also improves the~     peripheral air distribution in the lungs by increasing intrathoracic pressure.~      The objective of this study is to evaluate the effect of the breath-stacking (BS) technique~     on the ventilatory muscle strength of young and healthy individuals.~   "
23534|NCT03258931|"~     A phase III randomized multi-center study designed to compare the efficacy of crenolanib with~     that of midostaurin when administered following induction chemotherapy, consolidation~     chemotherapy and bone marrow transplantation in newly diagnosed AML subjects with FLT3~     mutation. About 510 subjects will be randomized in a 1:1 ratio to receive either crenolanib~     in addition to standard first line treatment of AML (chemotherapy and if eligible,~     transplantation) (arm A) or midostaurin and standard treatment (arm B). Potentially eligible~     subjects will be registered and tested for the presence of FLT3 mutation. Once the FLT3~     mutation status is confirmed and additional eligibility is established, subject will be~     randomized and enter into the treatment phase.~   "
23535|NCT03258918|"~     The investigators will conduct a single-arm mixed methods pilot study to estimate weight loss~     as well as the percentage of participants who achieve 5% weight loss in a 16-week,~     Low-Carbohydrate Diabetes Prevention Program (LC-DPP). Weight loss from the pilot LC-DPP~     cohort will be compared to weight loss outcomes from previously published DPP studies. The~     investigators will also evaluate secondary outcomes including change in physical activity,~     mental health, psychosocial functioning, and hemoglobin A1c over the 6-month study period.~   "
23536|NCT03258905|"~     The goal of this project is to continue to develop a smartphone application (app) to help~     youth from ages 18-25 who have a substance abuse problem. The app will engage them in~     grounding, which is a sensory-based experience to help them feel calm by reducing intense~     negative feelings and impulses (such as the urge to use a substance or hurt themselves or~     others).~   "
27579|NCT03205995|"~     The purpose of this study is to evaluate the platelet count change from baseline and safety~     of OMS721 in adults and adolescents with atypical hemolytic uremic syndrome (aHUS). The study~     will also evaluate pharmacokinetics (PK), pharmacodynamics (PD), and anti-drug antibody~     response (ADA).~   "
23538|NCT03258879|"~     Epidural, Combined Spinal-Epidural, and more recently dural puncture epidural are forms of~     neuraxial anesthesia used to provide pain relief in laboring women . The investigators want~     to assess the onset of pain relief with 2 different neuraxial techniques performed at our~     center, but which have not yet been compared in the literature: (1) Modified CSE, with only~     local anesthetic injected into the spinal fluid to reduce side effects of opioids that are~     seen with the traditional CSE and (2) Dural Puncture Epidural (DPE), involving puncture of~     the spinal membrane, but without injection of medication into the spinal space. The~     investigators hypothesize that the onset of labor analgesia will be faster with modified CSE~     compared to DPE.~   "
23539|NCT03258866|"~     The project was undertaking by Qilu Hospital of Shandong University in China. In order to~     compare the efficacy, safety and response duration of different dose of rituximab in patients~     primary immune thrombocytopenia(pITP).~   "
23540|NCT03258853|"~     The current study is designed to test the feasibility of the a wearable bionic pancreas~     system that automatically delivers insulin and glucagon can provide superior regulation of~     glycemia versus usual care for adults with cystic fibrosis related diabetes.~   "
23541|NCT03258840|"~     The aim of this study is to determining of the effects of Eicosapentaenoic acid (EPA)~     supplementation on serum activities of Paraoxonase-1 and Homocystein thiolactonase, and serum~     levels of some indicators of vascular inflammation, and the gene expression of PON2 in the~     peripheral blood mononuclear cell (PBMC) in the patients with type II diabetes mellitus.~   "
23542|NCT03258827|"~     As the proportion of older adults increases, elderly-related issues attract more attention.~     Sarcopenia is one of the popular elderly-related issues. Sarcopenia may induce decreased~     muscle strength, poor physical activity, even disability and increase rate of hospitalization~     and mortality. Therefore, we want to figure out the management for decreasing prevalence of~     sarcopenia in older adults. This trial is planned to perform during 2017/08/01~2017/12/31. We~     plan to enroll 60 elderlies who are sarcopenia. These patient will be divided into 2 group~     randomize. Experimental group will be received a set of exercise, composed by warm-up,~     strengthening training with a towel, cold-down, 60 minutes per time, 3 times per week.~     Control group will be suggested home-based walking activity. We will evaluate the patient's~     functional performance three times, before training, after training, post-training for three~     months, respectively. These results will be analyzed by repeated measure ANOVA.~   "
23543|NCT03258814|"~     This study is a non-interventional, longitudinal and non-confirmatory study to compare an~     active supervised training (AST) with standard of care (SOC) physiotherapy in patients with~     axial spondyloarthritis and stable response to adalimumab (HUMIRA®) with respect to~     health-related outcomes. The primary objective is the improvement in spinal mobility after a~     6 month training program. SOC physiotherapy will be prescribed on physicians and performed on~     physiotherapist's discretion. Further objectives are the improvement in physical function,~     health-related quality of life, disease activity, pain, psychosocial risk factors and~     workability.~   "
23544|NCT03258801|"~     The diagnosis of idiopathic pulmonary fibrosis (IPF) is currently one of the most common~     diagnoses for patients under evaluation for lung transplantation. In recent years, an~     absolute increase in prevalence/ incidence of IPF has been observed. There is evidence that~     patients with IPF on waiting list for lung transplantation might benefit from pirfenidone~     treatment. Until now, no data are published regarding this important issue in lung~     transplantation.~      Primary objective is to determine whether there is a difference in the duration time of~     mechanical ventilation (weaning) directly after lung transplantation between patients treated~     with pirfenidone and patients without pirfenidone treatment. The Secondary objectives are to~     determine whether there are differences between the pirfenidone treatment group and the~     control group regarding survival after LUTX, the score on the Saint Georges Respiratory~     Questionnaire and the decline in forced vital capacity (FVC%) In this Investigator initiated,~     non- interventional single center study , patients on the waiting list for transplant~     pirfenidone treatment receive oral pirfenidone at the standard dose of 2403 mg per day. The~     treatment duration will range from 6 to 12 months. A control group will be used to correlate~     the outcome-parameters for a descriptive comparison. The control group includes patients with~     IPF on the waiting list who were on another IPF specific (or no) treatment for IPF The Study~     Population are Patients aged between 40-70 years who are admitted to the lung transplantation~     department and fulfill the international criteria for idiopathic pulmonary fibrosis (~     existence of a usual interstitial pneumonia (UIP) pattern in the high-resolution computed~     tomography (HRCT) is necessary).~      Variables: Duration of mechanical ventilation after LUTX (hours), Forced Vital capacity~     relative to reference value at baseline (FVC0%), Forced Vital capacity relative to reference~     value after 6 months (FVC6%),Forced Vital capacity relative to reference value after 12~     months (FVC12%) Study Size: 30 patients in the Pirfenidone group, 20 patients in the control~     group.~      For the primary Endpoint, the mean, standard deviation, median, minimum and maximum of the~     weaning time of patients who received a pirfenidone treatment, as well as of patients from~     the control group will be computed and presented in a table. Additionally, a Kaplan-Meier~     curve will be estimated and plotted alongside the respective 95% CI calculated using the~     method of Brookmeyer and Crowley. Furthermore, a stepwise linear regression using forward~     selection and Age, RBMI, FVC0%, (FVC6%-FVC0%), TLC, FEV1% and ECMO, as well as the~     pirfenidone treatment as predictors will be computed. The null hypothesis is that the~     pirfenidone treatment has no influence on the weaning time. The according model coefficient~     estimate and standard error will be used to test the null hypothesis using a t-test at~     significance level α=0.05.~      For the secondary endpoints, the mean, standard deviation, median, minimum and maximum of~     patients who received a pirfenidone treatment, as well as of patients from the control group~     will be computed and presented in a tableStepwise Cox Regression using forward selection and~     Age, RBMI, FVC0%, (FVC6%-FVC0%) and ECMO, as well as the pirfenidone treatment as predictors~     will be computed in order to compare the treatment and the control group a . If p-values are~     calculated for the secondary endpoint analysis, they serve only descriptive purposes.~     Therefore no multiple testing corrections are applied.~   "
23545|NCT03258788|"~     Participants with Non-Small Cell Lung Cancer (NSCLC), Performance Status (PS) 0-2, not~     suitable for concurrent Chemo-Radiotherapy (CTRT), will be treated with standard radiotherapy~     (radical or palliative). Archival tumour biopsies will be analysed for baseline Programmed~     Death Ligand 1 (PD-L1) expression. Some participants will have a biopsy before radiotherapy~     if the archive biopsy is not suitable. Participants will be required to undergo an additional~     mandatory post radiotherapy course biopsy of the irradiated site ideally during the last 7~     days of radiotherapy or within 7 days of completing the course of radiotherapy.~   "
23546|NCT03258775|"~     A randomized, cross over study will assess the effects of ingestion of high and low volumes~     of water on REE over 90 minutes. The high volume of water 500ml and the low volume of water~     250ml. Participants will be computer randomized to determine which volume of water to receive~     first. Participants will arrive at the Nutrition Assessment Laboratory between 7:00 and~     7:30am following a 9 hour overnight fast. Participants will be instructed not to consume any~     food or drink after 10pm the night before the assessment. Participants will also be asked to~     abstain from alcohol and caffeine for 3 days before the assessment. After verification of~     eligibility, baseline REE will be measured for 30 minutes followed by administration of first~     assigned dose of water. REE will be monitored for the next 90 minutes. Blood pressure and~     heart rate will also be monitored, simultaneously to REE. After a 7-10 day washout period,~     participants will return for their second test day where the second dose of water will be~     administered. A 7-10 day washout period was selected to allow participants time to resume~     normal diet and hydration between visits.~   "
23547|NCT03258762|"~     Pyrimethamine in combination with a sulphonamide is known to be effective in the treatment of~     toxoplasmosis. However, Pyrimethamine has not been approved by the Japanese regulatory body~     (Pharmaceutical and Medical Devices Agency [PMDA]/ Ministry of Health, Labor and Welfare~     [MHLW]). The pharmacokinetics (PK) of Pyrimethamine has been investigated following~     administration of Sulfadoxine/Pyrimethamine tablet in healthy Japanese subjects. However, the~     study did not provide sufficient information for approval of Pyrimethamine in Japan; hence,~     PMDA has requested confirmation of the PK of Pyrimethamine in another PK study in Japanese~     and Caucasian healthy subjects. This study will be a single centre, open-label,~     parallel-group, single oral dose study to evaluate the PK, safety and tolerability of~     Pyrimethamine in healthy Japanese and Caucasian male subjects. Subjects will undergo a~     screening visit within 30 days prior to first dose of the study drug. On Day 1, subjects will~     be administered a single oral dose of pyrimethamine 50 milligrams (mg) along with calcium~     folinate 15 mg after an overnight fast of at least 10 hours. Subjects will continue to~     receive calcium folinate once daily until Day 8 of the treatment period. Blood sampling for~     PK analysis and safety assessments will be performed prior to dosing and over 22 days after~     dosing. Each subject will participate in the study for approximately 2 months from screening~     to follow-up.~   "
23585|NCT03258268|"~     A 26-week, multicenter, parallel two-arm, randomized controlled trial of the glycemic~     outcomes of individualized treatment support in patients with type 2 diabetes. The primary~     objective of the trial is to confirm the superiority of standard of care with EASY DSS versus~     standard of care without EASY DSS in terms of glycemic control in patients with type 2~     diabetes with ongoing treatment with any antidiabetic drug(s).~   "
23548|NCT03258749|"~     Chronic obstructive pulmonary disease (COPD) is a disease state characterized by persistent~     airflow limitation and associated with an accelerated decline in lung function, impaired~     quality of life, hospitalization, and increased mortality. As a major public health problem,~     COPD is predicted to rank as the fifth burden of diseases in the world by 2020. Thus,~     prevention of exacerbations is a important goal in the management of COPD. The Global~     Initiative for Chronic Obstructive Lung Disease (GOLD) Scientific Committee launched a joint~     project in 1998. Its goals were to raise awareness of COPD and to improve prevention and~     treatment of COPD patients around the world. In the 2017 GOLD guidelines, inhaled long-acting~     bronchodilators, including inhaled long-acting muscarinic antagonists (LAMAs) and inhaled~     long-acting beta-agonists (LABAs), are recommended for the management of all stable COPD~     patients. However, it is not known whether LABA or LAMA will be more effective for initial~     relief of symptoms in patients with GOLD A/B COPD. In this multicenter, randomized study, the~     investigators evaluate the efficacy of formoterol(LABA) and tiotropium(LAMA) in the treatment~     of patients with GOLD A/B COPD. The primary endpoint is postbronchodilator FEV1, and the~     secondary endpoints include the frequency of COPD exacerbation, other lung function~     parameters, CCQ score and mMRC/CAT score.~   "
23549|NCT03258736|"~     The caudal block is the most common technique for inguinal surgery. Increased use of~     ultrasound in regional analgesia techniques has been improved the practise of the peripheral~     nerve blocks. Ilioinguinal and iliohypogastric nerve blocks are possible to alternative~     methods to the central blocks. The aim of this study is to compare analgesic efficiency of~     caudal block and ultrasound guided Ilioinguinal and iliohypogastric nerve blocks for~     bilateral inguinal hernia in pediatric patients~   "
23550|NCT03258723|"~     Specific Aim: Implement an evidence-based diabetes prevention pragmatic trial for high risk~     pre-diabetic individuals of Caribbean-descent to reduce the incidence of diabetes.~      Hypothesis: This study seeks to test the hypothesis that implementation of a lifestyle~     intervention, with escalation to Metformin therapy will lower the incidence of diabetes among~     the highest risk pre-diabetic individuals of Caribbean-descent.~   "
23551|NCT03258710|"~     Tenofovir Disoproxil Fumarate is a nucleos(t)ide analogue that inhibits Hepatitis B Virus~     (HBV) growth, and is marketed in Japan with an indication for inhibition of HBV growth in~     subjects with chronic hepatitis B associated with HBV growth and abnormal liver function.~     This study has been planned to evaluate the virological effects and safety of switching from~     ETV to TDF in chronic hepatitis B (hepatitis B e-antigen [HBeAg])-positive and HBV-~     deoxyribonucleic acid (DNA) undetectable subjects. This study is designed as a multi-center,~     one-arm, post-marketing clinical study to investigate the HBsAg reduction in subjects who~     have not achieved the long-term goal, the loss of hepatitis B surface antigen (HBsAg). The~     study will be conducted in HBeAg-positive and HBV-DNA undetectable subjects treated with ETV.~     After switching ETV to TDF, TDF will be administered for 96 weeks. Approximately 80 subjects~     will be screened to achieve 65 evaluable subjects.~   "
23552|NCT03258697|"~     Total joint replacement is an ideal procedure to treat end stage joint disease. Good post-op~     pain relief could accelerate patient recovery and rehabilitation, and decrease admission days~     and medical cost. Local injection of LevoBupivacaine is an effective method in post-operative~     pain control. The effectiveness of local analgesia was noticed clinically. However, thorough~     studies about the pharmacokinetics of LevoBupivacaine, maintenance of effect, influence of~     post-operative rehabilitation are not well studied in different way of injection. The purpose~     of this study is to evaluate and analyze the pharmacokinetics and effect of local~     Levobupivacaine injection in different ways, the amount of post-operative fentanyl~     requirement after local injection, time to first fentanyl request, pain score, immediate~     post-operative function, side effect of analgesic agents, and medical cost, and to improve~     the quality of total joint replacement post-operative care.~   "
23553|NCT03258684|"~     In this prospective clinical study, the investigators compare the outcome and clinical course~     of consecutive septic participants treated with intravenous vitamin C, hydrocortisone, and~     thiamine (treatment group) with a control group treated in the investigators' ICU. The~     primary outcome is hospital survival. A propensity score is generated to adjust the primary~     outcome.There is 70 participants in each group.~   "
23554|NCT03258671|"~     This study is for patients with EFGR gene sensitive mutations diagnosed by pathology or~     cytology, having a course of chest radiotherapy treatment and molecular Target Therapy for~     the treatment of stage IV non-small cell lung cancer. Patients with non-small cell lung~     cancer have a risk of the tumour in the lung recurring or progressing after treatment.~      In this study, the investigators aim to verify the following hypothesis:~        -  whether in combination with concurrent or concomitant EGFR-TKI regimen chemotherapy,~          Intensity Modulated Radiation Therapy can reduce the risk of the tumour in the lung~          recurring or progressing similarily.~        -  Intensity Modulated Radiation Therapy concomitant with EGFR-TKI has a better normal~          tissue dose/volume tolerance than concurrent regimen.~        -  the survival can be improved by using this new molecular Target-radiotherapy method.~   "
23555|NCT03258658|"~     This is a Phase I clinical study to determine the safety and efficacy of using autologous,~     engineered urethral constructs for the treatment of urethral strictures in adult males.~      The proposed study design is a prospective non-randomized and uncontrolled single-center~     investigation. Autologous urothelial cells (UCs) and smooth muscle cells (SMCs), obtained~     from enrolled male subjects' bladder tissue samples, will be culture expanded in vitro and~     used to seed tubular PGA scaffolds to create autologous urethral constructs for the repair of~     urethral strictures.~   "
23556|NCT03258645|"~     This is an observational study in patients with non-valvular atrial fibrillation (NVAF)~     presenting to the hospital with a first acute ischemic stroke based on existing data recorded~     in the SITS International Registry (located in Sweden) by physicians in several European~     countries, such as Italy, United Kingdom, Czech Republic, Sweden, Germany, Poland, Spain,~     Finland, Portugal, Slovakia, Denmark, Estonia, Norway Belgium, Hungary, Slovenia, Croatia,~     Austria, Lithuania, France, Greece, Netherlands, Ireland, Ukraine and Iceland.~      The aim of this study is to explore the current real world use of dabigatran for stroke~     prevention in NVAF patients in the post-stroke setting. Secondary data from eligible European~     patients registered in the SITS registry will be considered; countries of origin are not~     known a priori.~   "
27606|NCT03205631|"~     Prospective, randomized crossover study to compare the NFT sleep patches to sham device to~     assess sleep via home sleep testing device in the home environment~   "
23557|NCT03258632|"~     This project aims to help Veterans who are in the hospital and have untreated alcohol~     problems. First, the investigators will adapt a Decision Aid that explains alcohol-related~     treatment options and their risks and benefits. Then, the investigators will determine the~     effectiveness of an intervention called DO-MoST (for Drinking Options-Motivate, Shared~     Decisions, Telemonitor), whereby a Decision Coach helps Veterans make decisions about~     alcohol-related behaviors and treatments they prefer, and keeps in contact by phone to~     continue to help with drinking and treatment decisions. DO-MoST is designed to increase rates~     at which Veterans decide to reduce or quit drinking, and begin and remain in treatment, and~     to improve drinking- and medical-related outcomes over time. It may also decrease Veterans'~     use of expensive health services such as hospitalizations and emergency visits. Finally, the~     investigators will study how VA can use DO-MoST on an ongoing, more widespread basis. The~     project should increase patient-centered health care for Veterans with alcohol problems to~     benefit their recovery.~   "
23558|NCT03258619|"~     Septic shock is responsible in 20% of cases of acute adrenal insufficiency and in 50% of~     cases of chronic 'slow' adrenal insufficiency. Given the unpredictable nature of the response~     to the ACTH stimulation test, it is recommended to systematically start steroid replacement~     therapy with hydrocortisone hemisuccinate (HCHS) in patients in septic shock who do not~     respond to fluid resuscitation and who continue to suffer from haemodynamic instability~     despite increasing doses of noradrenaline.~      The interest of this corticosteroid therapy lies in its ability to reduce the duration of~     treatment with catecholamines, though the results are conflicting with regard to an eventual~     benefit for mortality.~      Steroid replacement therapy may be deleterious. It may increase the risk of sepsis and~     secondary septic shock. It is also implicated in critical-illness polyneuropathy and blood~     glucose dysregulation.~      Today, there is no way to identify a population of patients who respond to corticosteroid~     therapy.~      From a pathophysiological viewpoint, HCHS, as well as its glucocorticoid effects, may also~     exert mineralocorticoid effects able to compensate for the impaired renin angiotensin~     aldosterone system (RAAS), which is responsible for the refractory aspects of septic shock.~      This hyperreninism-hypoaldosteronism is found with a prevalence of around 50% of cases and is~     defined by a plasma aldosterone/ plasma renin ratio < 2. It is associated with natriuresis~     >30 mmol/l.~      We hypothesise that natriuresis > 30 mmol/l will make it possible to identify patients who~     respond to steroid replacement therapy in terms of catecholamine use.~   "
23559|NCT03258606|"~     Background:~      Many medical conditions such as Alzheimer s disease limit the ability of people to think~     clearly. For medical scientists to best study these medical conditions, they need to enroll~     some people who may not be able to consent to participate in research on their own. Before~     these individuals enroll in research it is important to assess whether they are able to~     consent or whether someone else will need to consent for them. The NIH Clinical Center has a~     team that performs these assessments. A team like this can be useful for two reasons. First,~     it helps to protect the rights of research participants. Second, it makes it possible to~     study medical conditions that could not be studied otherwise. In this study we will look back~     at the records of the NIH Clinical Center team to review the process and results of these~     assessments. We expect to learn how the capacity assessments were done. We will learn what~     factors make people more or less able to consent. We will learn who consented for the~     research participants when they could not consent on their own, for example a spouse or an~     adult child. These results are likely to be useful to other researchers who wish to study~     diseases that limit cognitive ability.~      Objective:~      To study the process and outcomes of capacity assessments of people who may not be able to~     consent to research.~      Eligibility:~      People of all ages, genders, races, ethnicities, and languages whose ability to consent was~     assessed at the NIH Clinical Center at some time during the years 1999-2016.~      Design:~      This study will only review existing records. There will not be any active participants.~      Records will be reviewed for research only. This will take place in the Clinical Center. It~     will be done by staff of the Department of Bioethics and the Human Subjects Protection Unit~     (HSPU).~      The study will collect data from the Bioethics Consult database. It will also collect data~     from HSPU records.~      Researchers will look at demographic data. They will look at details of capacity evaluations.~      Personal data will not be extracted from existing records.~   "
23560|NCT03258593|"~     Background:~      Non-muscle-invasive bladder cancer is in the early stages. But it usually comes back after~     treatment. The drugs Vicinium and Durvalumab may help the immune system find and destroy~     cancer cells.~      Objective:~      To test if the drugs Durvalumab and Vicinium together are safe and effective to treat people~     with bladder cancer that has not spread to the muscle in the bladder.~      Eligibility:~      People ages 18 and older who have bladder cancer that has not spread to the muscle in the~     bladder and was treated unsuccessfully with Bacillus Calmette-Guerin~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Blood and urine tests~      Tumor sample from previous surgery. If one is not available, they will have a biopsy: A small~     piece of tumor is removed.~      Cystoscopy to examine the inside of the bladder. This may include a biopsy or removing~     tumors.~      CT or MRI: They lie in a machine that takes pictures of the body.~      Electrocardiogram to test heart function~      Participants will receive Durvalumab and Vicinium in 2 phases:~      First phase: Durvalumab every 4 weeks and Vicinium once a week for 3 months~      Second phase: Durvalumab every 4 weeks and Vicinium once every other week~      Participants will have tumor samples taken every 3 months. They will have blood and urine~     tests throughout the study.~      Participants will continue treatment for up to 2 years.~      Participants will have a visit about 30 days after their last treatment. This includes blood~     and urine tests. It may include a cytoscopy or additional biopsies.~   "
23561|NCT03258580|"~     Background:~      People can feel different levels of pain. This may depend on social, cultural, and biological~     factors. These factors can also influence how people respond to each other, and how they~     judge other people s experiences. Researchers want to learn more about these relationships.~      Objective:~      To study if social and cultural factors lead to differences in pain experience and how pain~     is interpreted by other individuals.~      Eligibility:~      Healthy adults ages 18-60~      Design:~      Participants will have 1 or 2 visits.~      Participants will be screened with a medical history and nursing assessment.~      Participants may have the following:~      Electric shock through small sticky pads on the arm, leg, or foot.~      Thermal stimulation. A device called a thermode will be placed on the arm, leg, or foot. A~     computer controls the thermode temperature.~      Lowering their hand into very cold water.~      Videos or pictures of the face will recorded while participants get painful stimulation.~      A test to record heart electrical activity. Small metal disc or sticky pad electrodes will be~     placed on the chest.~      Pulse rate and breathing measured. Sweating will be measured with two small sensors stuck on~     the hand.~      A test to measure the electrical activity of facial muscles. Small metal disk or sticky pad~     electrodes will be attached to the skin.~      Viewing pictures and/or videos of other people who get painful and nonpainful stimulation.~      Participants will make decisions about the images. They will respond by keyboard, mouse, or~     button.~      Eye tracking. A camera will measure participants pupil size and follow their eye movements.~   "
23562|NCT03258567|"~     Background:~      The drug Nivolumab has been approved to treat some cancers. Researchers want to see if it can~     slow the growth of other cancers. They want to study its effects on cancers that may have not~     responded to chemotherapy or other treatments.~      Objectives:~      To see if Nivolumab slows the growth of some types of cancer or stops them from getting~     worse. To test the safety of the drug.~      Eligibility:~      People 12 and older who have Epstein-Barr Virus (EBV)-positive lymphoproliferative disorders~     or EBV-positive non-Hodgkin lymphomas with no standard therapy~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Blood and urine tests~      CAT scan of the chest, abdomen, and pelvis~      Tumor and bone marrow biopsies (sample taken)~      Magnetic resonance imaging scan of the brain~      Lumbar puncture (also known as spinal tap)~      Positron emission tomography/computed tomography scan with a radioactive tracer~      Every 2 weeks, participants will get Nivolumab by vein over about 1 hour. They will also~     have:~      Physical exam~      Blood and pregnancy tests~      Review of side effects and medications~      During the study, participants will repeat most of the screening tests. They may also have~     other biopsies.~      After stopping treatment, participants will have a visit every 3 months for 1 year. Then they~     will have a visit every 6 months for years 2-5, and then once a year. They will have a~     physical exam and blood tests.~   "
23563|NCT03258554|"~     This randomized phase II/III trial studies how well radiation therapy works with durvalumab~     or cetuximab in treating patients with stage III-IVB head and neck cancer who cannot take~     cisplatin. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.~     Monoclonal antibodies, such as durvalumab and cetuximab, may interfere with the ability of~     tumor cells to grow and spread. It is not known if radiation therapy with durvalumab will~     work better than the usual therapy of radiation therapy with cetuximab in treating patients~     with head and neck cancer.~   "
23564|NCT03258541|"~     For advanced rectal tumors, the standard of care is neoadjuvant radiotherapy (RT) +/-~     chemotherapy followed by surgery 8-10 weeks later. Despite its proven efficacy in reducing~     local relapse, the neo-adjuvant treatment has been associated to non-negligible side effects,~     especially in terms of impaired sexual function. For females, pelvic RT is frequently~     associated to long-term complications such as vaginal stenosis (VS), vaginal dryness, and~     dyspareunia, while in men RT doses delivered to the neurovascular peri-prostatic bundles and~     penile bulb have been associated to the risk to develop erectile dysfunction.~      In prostate cancer, hydrogel spacers have been evaluated to create space between the target~     (prostate) and the organ (rectum) to be spared during radiotherapy treatments. Clinical~     studies have shown the ease of spacer application; patient tolerance and, good clinical~     outcomes (decrease in rectal toxicities).~      This pilot study wishes to investigate feasibility and efficacy of the injected hydrogel~     spacers TraceIT® in sparing vagina/prostate in the treatment of rectal cancer patients.~   "
23565|NCT03258528|"~     Objective: to evaluate the effect of right lateral positioning in comparison with supine~     positioning on tracheal aspirate pepsin levels as a marker of aspiration of gastric contents~     in ventilated preterm neonates. Study design: This randomized controlled trial was conducted~     on 60 ventilated preterm neonates < 35 weeks. They were randomized into 2 groups; one group~     composed of 30 neonates that were nursed in right lateral position for 6 hours while the~     other group composed of 30 neonates that were nursed in supine position for 6 hours. Tracheal~     aspirate sample was obtained from each neonate in both groups just after the end of 6 hours~     and pepsin level was measured.~   "
23566|NCT03258515|"~     This is a randomized, placebo-controlled, double-blind, 3-way crossover phase I study being~     conducted on healthy volunteers to investigate the effect of single dose of AZD6094 (600 mg)~     on cardiac repolarization under well-controlled conditions in accordance with the~     International Council for Harmonization (ICH) E14 guidelines. An open-label Moxifloxacin (400~     mg), a fluoroquinolone broad spectrum antibiotic will be used as a appositive control for the~     time between the start of the Q wave and the end of the T wave (QT) prolongation in~     accordance with ICH E14 guidelines, to establish assay sensitivity. The core study consists~     of screening period, 3 treatment period (AZD6094, placebo and moxifloxacin; with a minimum~     washout period of 14 days between each treatment period) and follow-up. The study drugs will~     be administered orally. The study is planned to determine effect of AZD6094 at therapeutic~     dose, safety and tolerability. This study provides adequate and well-controlled mechanisms to~     deal with potential bias, facilitate identification of effects related to investigational~     product (IMP) administration and tolerability issues.~   "
23567|NCT03258502|"~     The main aims of the study are to assess the safety, pharmacokinetics and antiviral activity~     of multiple doses of RV521 compared to placebo in healthy adult subjects infected with~     Respiratory Syncytial Virus (RSV) in the Virus Challenge Model~   "
23568|NCT03258489|"~     Hypertension is considered a serious public health problem. The imbalance in autonomic~     nervous system (ANS) activity is one of the main triggers in the development and maintenance~     of hypertension. The non-pharmacological management of this disease is an important resource,~     especially in refractory hypertensive patients or in hypertensive crises, where the~     pharmacological treatment does not present an efficient response. It is known that~     transcutaneous electrical nerve stimulation (TENS) is capable of modifying the autonomic~     balance, however, the effects of Interferential electrical stimulation (IES) on this system~     in normotensive and hypertensive volunteers are not yet known. These electrotherapeutic~     resources may be a non-pharmacological tool supporting the management of hypertension. The~     objective of this research is to study the effects of different TENS and IC parameters on~     cardiovascular variables of normotensive volunteers and hypertensive patients.~   "
23586|NCT03258255|"~     The aim of this prospective randomized study is to assess the analgesic efficacy of Pudendal~     block compared with penil block for pediatric patients undergoing circumsion concerning~     postoperative analgesic consumption within 24 hours.~   "
23587|NCT03258242|"~     This is a study aiming to assess the efficacy and safety of Keluo Xin capsule in patients~     with moderately severe to severe nonproliferative diabetic retinopathy (NPDR). Two-thirds of~     participates will receive Keluo Xin capsules while other one third will receive placebo.~   "
23588|NCT03258229|"~     This study was conducted to investigate the effects of daily supplementation of Angelica~     gigas N. extract on improvement of Hyperglycemia .~   "
23569|NCT03258476|"~     Teenagers are invited to take part voluntarily in a research study of a study drug known as~     guanfacine extended release (Intuniv™) and a type of psychotherapy called Mindfulness Skills~     Training which teaches people how to focus on the present moment in a nonjudgmental manner to~     help them cope with their stresses and worries. Teenagers are being asked to take part in~     this study if they have had traumatic stress related over arousal symptoms. He/she may also~     have difficulties with worries, anxiety, temper, aggression, quick mood changes, behavior~     problems, and/or difficulties with symptoms of Attention Deficit Hyperactivity Disorder~     (ADHD) including inattention, hyperactivity, and impulsivity with or without Posttraumatic~     Stress Disorder (PTSD); and is not responding adequately to his/her current treatment.~      The primary purpose of the teenager's participation in this study is to help answer the~     following research question(s), and not to provide treatment for his or her condition:~        -  To investigate if Intuniv™ helps for the symptoms of traumatic stress and emotional and~          behavioral overarousal in children with a history of traumatic developmental stress with~          and without PTSD.~        -  To investigate if Intuniv™ helps your teenager engage with and benefit from Mindfulness~          Skills Training therapy~        -  To better understand how Intuniv™ works in the brain.~        -  To investigate how well your child tolerates Intuniv™ during the study.~   "
23570|NCT03258463|"~     This will be a retrospective cohort study comparing women obtaining an abortion in New Mexico~     and living in Texas and women obtaining an abortion in New Mexico and living in New Mexico .~   "
23571|NCT03258450|"~     Studies have reported about one-third to half of advanced cancer patients experience~     psychological distress yet the mental healthcare needs of these patients are not properly~     assessed and addressed. Patients with advanced colorectal cancer can face unique challenges~     that are stoma- or bowel-related in addition to other symptom burden such as pain, fatigue,~     and existential distress that have deleterious consequences on their psychological and social~     functioning. This pilot study aims to test an intervention for patients specifically with~     advanced colorectal cancer that incorporates culturally-appropriate topics. Using a~     randomized selection design, we will investigate the feasibility and acceptability of the~     intervention and obtain an initial estimate of efficacy of the intervention. This pilot study~     will yield useful information to inform the preparation of a larger, phase III confirmatory~     study.~   "
23572|NCT03258437|"~     This study was conducted to investigate the effects of daily supplementation of Allium cepa~     L. and Cuscuta chinensis Lam. Extract Mixtures (DA-9401) on improvement of sperm motility.~   "
23573|NCT03258424|"~     The trial will consist of a single treatment group enrolling adult subjects with CF on~     background therapy with KALYDECO®. Approximately 16 subjects will be enrolled.~   "
23574|NCT03258411|"~     Evaluating and comparing the short term effects of different palatal expanders on the amount~     of palatal expansion and buccal tipping of posterior teeth.~      Hypothesis:~      H0: There is no difference in the short term effects between the different palatal expanders.~      H1: There is a significant difference in the short term effects between the different palatal~     expanders.~   "
23575|NCT03258398|"~     This is a Phase 2, open-label, 2-part, multicenter study in subjects with MSS~     relapsed/refractory colorectal cancer. The primary objective of Part 1 is to evaluate the~     safety and tolerability of escalating doses of eFT508 in combination with a fixed dose of~     avelumab to determine the maximum tolerated dose (MTD) of eFT508 and to select a recommended~     dose for Part 2. The primary objective of Part 2 is to evaluate antitumor activity of eFT508~     at the recommended dose in combination with avelumab or eFT508 monotherapy. Parts 1 and 2~     will also evaluate pharmacokinetics (PK) and pharmacodynamics.~   "
23576|NCT03258385|"~     Impaired vitamin B12 (B12) status during pregnancy is associated with increased risk of birth~     defects and common complications (e.g. intrauterine growth restriction, neural tube defects),~     and possibly immune function impairment. The newborns and infants of B12-deficient mothers~     have low B12 stores at birth, further exacerbated by a very low concentration of B12 in~     breast milk that may hinder their growth and development. In regions such as Bangladesh, many~     women of reproductive age have inadequate B12 status, probably due to low intake of animal~     source food. Vitamin B12 intake and status in pregnancy and lactation is potentially~     insufficient to prevent impaired child development and immune function related to inadequate~     B12 status. The investigators hypothesize that prolonged vitamin B12 supplementation through~     fortified milk starting from early pregnancy up to 6 mo-postpartum will improve: (1)~     biomarkers of vitamin B12 status in mothers-infant pairs (2) vaccine specific adaptive~     immunity in infants; (3) neurological and cognitive function in infants.~   "
23577|NCT03258372|"~     This is a Phase 1, single center, fixed sequence, open label, drug-drug interaction study of~     the effect of multiple doses of rifampin 600 mg daily, a strong CYP3A inducer, on the~     exposure of mifepristone at 2 dose levels.~   "
23578|NCT03258359|"~     This study will evaluate the safety of autologous T cells that have been immunized ex vivo~     with patient-specific MDS stem cell neoantigens in patients with MDS.~   "
23579|NCT03258346|"~     A research study regarding the body's response to several weeks of training using short~     sprints and pomegranate juice supplementation~   "
23580|NCT03258333|"~     In this prospective single-center study included 60 patients with a severe degenerative~     aortic stenosis and small aortic annulus (<21 mm) who underwent standard AVR with stented~     bioprosthesis (group 1, n=30) and aortic valve reconstruction using autologus pericardium~     (Ozaki procedure) (group 2, n=30)~   "
23581|NCT03258320|"~     Current agents administered in therapeutic regimens of prostate cancer employ different~     mechanisms to eliminate neoplastic cells by inducing substantial apoptosis and causing tumor~     regression. Treatment with neoadjuvant chemotherapy before radical prostatectomy may better~     control the tumor before it has the chance to convert into the disease of~     castration-resistant prostate cancer (CRPC), which is finally refractory to most modalities~     of clinical intervention with a clinically lethal nature.~   "
23582|NCT03258307|"~     Omentum is adipose tissue lying under inner anterior wall Omentectomy is routine procedure in~     treatment of gynecological malignancy especially ovarian cancer and some advanced stage~     endometrial cancer. Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin, Estrone~     secrete from adipose tissue. These regulate matabolic process.~      We aimed comparison of Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin,~     Estrone levels derivated from adipose tissue pre-postoperatively in patient diagnosed with~     gynecological malignancy performed omentectomy or not~   "
23589|NCT03258216|"~     The Automatic Tongue Diagnosis System (ATDS) was developed to capture tongue images and~     extract features reliably to assist the diagnosis of TCM practitioners.This project will~     employ the ATDS verified to extract the tongue features of patients with upper~     gastrointestinal disorders, such as peptic ulcer, etc. A TCM indices derived through the~     non-intrusive tongue diagnosis procedure can provide valuable information for clinical~     doctors to analyze the current status of a patient and dynamically schedule a treatment plan,~     facilitating early detection and diagnosis of upper gastrointestinal disorders.~   "
23590|NCT03258203|"~     The purpose of this study is to test the interactions between the genes and diet~     interventions varying in macronutrient intake on glycemic, waist circumference, body weight,~     visceral fat and lipids changes. In the POUNDS LOST, all of the 811 participants DNA was~     extracted from the buffy coat fraction of centrifuged blood using the QIAmp blood kit~     (Qiagen, Chatsworth, CA). Single nucleotide polymorphisms were genotyped using the OpenArray™~     SNP genotyping system (BioTrove, Woburn, MA). The study is only accepting participants in the~     Boston, Massachusetts or Baton Rouge, Louisiana area. For further enrollment information in~     Boston or Baton Rouge, see Eligibility Criteria or Design Narrative.~      Besides, the investigators integrated novel pathway analyses in large cohorts and~     comprehensive genetic analyses on long-term weight loss and mechanisms in randomized diet~     intervention trials would provide very important evidence to unravel the etiology of obesity,~     and have significant public health and clinical implications. Establishing relationship~     between genetic variants and diets in determining weight change will help identify~     individuals at high risk for obesity especially when adherent to specific diet.~   "
23591|NCT03258190|"~     Lime powder regimen (LPR) is a limeade-derived composition enrichs with citrate/citric acid~     and potassium. LPR was invented to treat the renal stone patients with high risk of stone~     recurrence after stone removal. LPR should have equal or higher efficacy and lower adverse~     effect than current standard medicine.~   "
23592|NCT03258177|"~     The purpose of this study is to implement and evaluate postoperative virtual care visits for~     patients who undergo a laparoscopic appendectomy, laparoscopic cholecystectomy, or robotic~     cholecystectomy. The investigators aim to better understand whether postoperative virtual~     care visits will not result in a greater composite measure of the occurrence of hospital~     encounters within Carolinas HealthCare System (CHS) for the 30 days following surgery than~     standard in-person clinic care. The investigators also aim to better understand whether~     postoperative virtual care visits provide time and cost savings, and provide equal or~     improved patient satisfaction and convenience.~   "
23593|NCT03258164|"~     The purpose of the present study is to examine whether enrichment of a fat graft with~     autologous ex vivo expanded ASC injected into the breast tissue or face, both for cosmetic~     use, will significantly improve the results of conventional lipofilling and synthetic facial~     fillers, thereby being able to offer a safer, more natural and long-lasting alternative to~     current artificial solutions for cosmetic patients.~   "
23594|NCT03258151|"~     Taxanes are one of the most active agents in the treatment of many kinds of solid tumors,~     mainly including paclitaxel and docetaxel. However, variability in toxicity and response~     remains a major problem for patients receiving taxanes. It is general that there are many~     factors for individual differences of drugs in clinical application, of which genetic factors~     accounted for more than 20%. Toxicities of docetaxel, such as myelosuppression, neurotoxicity~     or mucositis, were evaluated for possible relationship with pharmacogenetic polymorphisms in~     several candidate gene and genome-wide association studies. Due to the levels of evidence of~     those studies are low and lack of sufficient research data of Chinese, it has the important~     significance in studying individual differences of docetaxel in toxicities, through the~     pharmacogenomics research.~      The aim of this study is to evaluating the association genetic polymorphisms with~     docetaxel-based chemotherapy toxicities in chinese solid tumor patients. By detecting the~     gene polymorphism, investigators intend to study the pharmacokinetic/pharmacogenomics (PK-PG)~     correlation of docetaxel and provide scientific basis for precise medication guide for people~     to use docetaxel.~   "
23595|NCT03258138|"~     Chronic conditions, such as obesity and diabetes, are increasing worldwide. Lifestyle changes~     (e.g., physical activity, healthy diet, sufficient sleep, managing stress, smoking cessation)~     are often recommended to prevent or manage these conditions, but changing habits is~     difficult. Mental health can play a role in the ability to seek out and follow through on the~     changes necessary to achieve or maintain a healthy lifestyle, yet this aspect is rarely~     addressed, and access to mental health services is often limited. Furthermore, individuals~     are influenced by factors at the individual, interpersonal, community and policy levels~     (e.g., lack of socialization, unsafe neighborhoods). These factors can act as barriers and~     need to be addressed in order for individuals to make sustainable lifestyle changes.~      A new year-long person-centered healthy lifestyles program is proposed to address the how~     to gap in making lifestyle changes through a combination of individual and group sessions.~     The feasibility and implementation of this new program will be evaluated through a pilot~     study looking at the full healthy lifestyles program compared to a less intensive version of~     the program. The study's hypothesis is that the full program will be feasible, acceptable and~     more effective for helping participants move across stages of change and for meeting their~     goals than the less intensive program.~   "
23596|NCT03258125|"~     Preeclampsia is a pregnancy related disease characterized by the new onset of hypertension~     and proteinuria after 20 weeks of gestation in previously normotensive women. PE is one of~     the most challenging diseases in obstetrics worldwide that affects 2-8 % of pregnancies~     causing both morbidity and mortality of both mother and fetus.~   "
23597|NCT03258112|"~     Ventricular arrhythmias arising from cardiac outflow tract affect quality of life and can~     cause decrease in left ventricular ejection fraction.~      Drugs used for treating those arrhytmias may be ineffective or may have side effects.~      Radiofrequency catheter ablation can be used safely for treatment of outflow tract~     arrhythmias.~      There are different sites where those ventricular arrhythmias may originates, each site has~     different electrocardiographic characteristics, different procedural success rates and~     challenges in localization and ablation.~   "
27299|NCT03209674|"~     The registry for the improvement of postoperative outcomes in cardiac and thoracic surgery~     aims to prospectively collect data in order to test the association between various~     preoperative and per-operative variables ; and several postoperative outcomes such as~     mortality, shock, redo surgery, sepsis and extracorporeal life-support.~   "
23598|NCT03258099|"~     Capecitabine is one of the most active agents in the treatment of many kinds of solid tumors.~     However, variability in toxicity and response remains a major problem for patients receiving~     capecitabine. It is general that there are many factors for individual differences of drugs~     in clinical application, of which genetic factors accounted for more than 20%. Toxicities of~     capecitabine, such as diarrhea, hand-foot syndrome or anemia, were evaluated for possible~     relationship with pharmacogenetic polymorphisms in several pharmacogenomics studies. Due to~     the levels of evidence of those studies are low and lack of sufficient research data of~     Chinese, it has the important significance in studying individual differences of capecitabine~     in toxicities, through the pharmacogenomics research.~      The aim of this study is to evaluating the association genetic polymorphisms with~     capecitabine-based chemotherapy toxicities in chinese solid tumor patients. By detecting the~     gene polymorphism, investigators intend to study the pharmacokinetic/pharmacogenomics (PK-PG)~     correlation of capecitabine and provide scientific basis for precise medication guide for~     people to use capecitabine.~   "
23599|NCT03258086|"~     Vitamin D is so-called sunshine vitamin,it is synthesized in the skin during exposure to~     the ultraviolet rays in sunlight so it has been suggested that ∼ 5-30 minutes of sun exposure~     between 10:00 a.m. and 3:00 p.m. at least twice per week on the skin of the face, arms, back,~     or legs (without sunscreen) is usually adequate for vitamin D synthesis. Vitamin D is also~     found in plants (mainly mushrooms and yeast) and in a few foods such as fatty fish.~      Vitamin D supplement is recommended in all infants until enough formula, milk, or other food~     sources are ingested to sufficiently provide 400 IU/day to prevent vitamin D deficiency. Type~     1 diabetes is an autoimmune disease, and the self immune system plays a central role in the~     destruction of the beta cell of pancrease.~   "
23600|NCT03258073|"~     In Uganda and many countries in Sub-Saharan Africa, health providers have minimal training~     and intermittent opportunity to maintain skills in managing delivery complications and acute~     newborn and pediatric conditions. Interventions like effective resuscitation assistance at~     the time of birth are lifesaving. Every 30 second delay in establishing effective~     resuscitation at birth increases the risk of death by 16%. The purpose of this study is to~     test whether medical simulation can improve acute care skills and confidence related to~     maternal and pediatric care emergencies.~   "
23601|NCT03258060|"~     Cardiac Resynchronisation Therapy (CRT) is a specialist pacemaker procedure that aims to~     improve the efficiency of the heartbeat. This treatment is used routinely in patients with~     heart failure and a delay in electrical conduction across the heart seen on the surface ECG~     (heart tracing). Also CRT has been seen to improve some heart failure patients with a normal~     electrical conduction (seen on the ECG as a narrow QRS complex). The investigators aim to see~     if cardiac MRI can be used to select patients with normal electrical conduction for CRT,~     therefore expanding the number of people who would stand to benefit from this treatment.~   "
23602|NCT03258047|"~     It's a single arm, open label prospective study, in which the safety and efficacy of~     autologous CAR-T are evaluated in refractory/relapsed B cell lymphoma patients.~      Abbreviation: CAR-T: Chimeric Antigen Receptor T-Cell Immunotherapy.~   "
23603|NCT03258034|"~     The prognosis of Extensive lymph nodes metastatic(ELM) gastric cancer is poor. Chemotherapy~     occasionally converts it to a resectable cancer. Previous studies showed patients with ELM~     gastric cancer may obtain a survival benefit from chemotherapy and subsequent curative~     surgery. The key of conversion therapy of ELMGC is the high response rate. Apatinib, a novel~     targeted inhibitor of VEGF receptor 2 (VEGFR2), shows significant antitumor activity in the~     patients with GC. On the basis of our previous Ahead-G325 study, The purpose of this study is~     to investigate the efficacy and safety of S1/Paclitaxel chemotherapy plus Apatinib in the~     conversion therapys of ELM gastric cancer.~   "
23604|NCT03258021|"~     The purpose of this post-authorisation medical device study is to obtain real life data on~     the use of tumor-treating fields (TTFields) in patients with newly diagnosed GBM in routine~     clinical care in Germany. Patients with newly diagnosed GBM and clinical indication for~     TTFields treatment will be enrolled in the study after signing Informed consent to use their~     data and process it centrally for research purposes. The clinical indication for TTFields is~     one of the inclusion criteria and is defined prior to inclusion by the treating physician.~     The patient's decision regarding TTFields treatment is part of the observation and will be~     assessed within the baseline visit.~   "
23605|NCT03258008|"~     The goal of this clinical research study is to learn if utomilumab, when given with ISA101b,~     is able to shrink or slow the growth of tumors in patients with incurable HPV+ oropharyngeal~     squamous cell carcinoma.~      This is an investigational study. Utomilumab and ISA101b are not FDA approved or commercially~     available. They are currently being used for research purposes only. The study doctor can~     explain how the study drugs are designed to work.~      Up to 27 participants will be enrolled. All will take part at MD Anderson.~   "
23606|NCT03257995|"~     This study is a randomized, double-blind, placebo-controlled, three-period cross-over study~     in approximately 54 subjects with asthma.~   "
23607|NCT03257982|"~     This study aims to assess the feasibility of therapist-caregiver-patient training to use BCI~     and FES technology with a view to the inexpensive equipment eventually being used for home~     use by tetraplegic patients as a continuing rehabilitation method for sub-acute patients~     discharged from hospital.~   "
23623|NCT03257761|"~     This phase Ib trial studies the side effects and best dose of guadecitabine and how well it~     works when given together with durvalumab in treating patients with liver, pancreatic, bile~     duct, or gallbladder cancer that has spread to other places in the body. Guadecitabine may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~     Monoclonal antibodies, such as durvalumab, may block tumor growth in different ways by~     targeting certain cells. Giving guadecitabine and durvalumab may work better in treating~     patients with liver, pancreatic, bile duct, or gallbladder cancer.~   "
23711|NCT03256591|"~     Helping Babies Breathe (HBB) implementation is associated with reduction in neonatal deaths~     and reduction in fresh stillbirths. HBB has successfully integrated some aspects of~     simulation into an educational curriculum that teach the management of neonatal emergencies~     in resource-constrained countries.~      Simulation based training brings special advantages and may enhance HBB training. Critical~     elements of simulation such as enhanced realism and post-event debriefing may carry potential~     to strengthen HBB training to attain maximum impact. However, evidence for the effectiveness~     of this combined approach is limited.~   "
23608|NCT03257969|"~     The rise of oral anticancer drugs favors outpatient care but exposes patients to new risks~     compared to injectable chemotherapy at hospital: non-adherence to treatment, inappropriate~     management of side effects and interactions with other co-prescribed drugs. Latrogenic risk~     of these treatments is reinforced in older patients with frequent comorbidities, taking~     multiple pharmaceutical treatments for long periods and followed by several prescribers.~      The literature reports an emergence of drug related problems (DRP) in more than 90% of~     patients, with an average number of 0 to 4 per patient. The clinical consequences (reduced~     efficacy and potentiation of toxicity) are all the more important that outpatient monitoring~     of treatments prescribed at the hospital remains underdeveloped due to default of~     coordination between these two settings.~      Medical care and prevention of these DRP are difficult because of a lack of information and~     tools shared between hospital and liberal actors. Experiments are developed according to~     different organizational models, frequently focused on the pharmaceutical analysis of~     prescriptions, the detection of DRP and their control, but they stay still undervalued. In~     this context, the French Society of Oncological Pharmacology (SFPO - Société Française de~     Pharmacie Oncologique) provides to hospital and ambulatory care pharmacists the Oncolien~     website and proposes to assess the impact of a program of pharmaceutical interventions named~     DROP. The hypothesis of the study is that the DROP program will secure the medical care of~     patients with oral anticancer drugs compared to the usual care.~   "
23609|NCT03257943|"~     A Multi-Center, Double-Blind, Randomized, Placebo controlled, Parallel-group study, comparing~     Ivermectin Lotion, 0.5%~   "
23610|NCT03257930|"~     Use of ethanol injection in treatment of cystic thyroid nodule~   "
23611|NCT03257917|"~     The overall objective of this project is to gain knowledge about out-of-pocket (OOP) expenses~     and lost opportunity costs among metastatic breast cancer (MBC) patients. To achieve this~     objective, MBC patients will be asked to participate in a short, 37-question survey asking~     questions about the financial burden, OOP expenses, and opportunity costs related to their~     cancer care~   "
23612|NCT03257904|"~     Intracranial pressure (ICP) monitoring is the most common neuromonitoring modality used in~     neurocritical care (NCCU) around the world. Uncertainties remain around intracranial pressure~     monitoring both in traumatic and non-traumatic brain injury, and variation in clinical~     practice of intracranial pressure monitoring exists between neurocritical care units.~      The objectives of the study will explore intracranial pressure monitoring variation in~     practice to prioritise uncertainties in the clinical management of critical care patients~     with acute brain injury and support further collaborative hypotheses-based prospective~     studies.~   "
23613|NCT03257891|"~     Adrenocortical cancer (ACC) is a rare aggressive tumor. The treatment of metastatic ACC is~     challenging and the current available treatments are mitotane, chemotherapy or the~     combination of both. Prognosis in locally advanced inoperable and metastatic ACC patients~     still remains poor, the 5-year overall survival being <15%. New treatment strategies are~     therefore needed. The taxanes are a class of drugs targeting the microtubules that have shown~     to be effective in the treatment of several malignancies but have not been fully developed in~     patients with ACC. Cabazitaxel is a new taxoid which promotes the tubulin assembly in vitro~     and stabilizes microtubules against cold-induced depolymerization as efficiently as~     docetaxel. Cabazitaxel was selected for development based on a better antiproliferative~     activity on resistant cell lines than docetaxel. The activity of the drug against several~     malignancies is currently tested in ongoing prospective studies, but to our knowledge neither~     preclinical nor clinical studies are currently testing cabaztaxel in ACC. This study is aimed~     to demonstrate that cabazitaxel is active in ACC, but the drug was never tested before in~     this clinical setting. A prospective, non-randomized, multicentre, open label, single arm,~     phase II study will be conducted in patients with advanced ACC. The phase II study will be~     conducted in 2 different Italian Institutions that are reference centers for ACC.~   "
23614|NCT03257878|"~     To compare the health related quality of life of patients with systemic sclerosis with other~     rheumatic diseases, such as rheumatoid arthritis, systemic lupus erythematosus and Sjogren's~     syndrome.~   "
23615|NCT03257865|"~     To Demonstrate the Efficacy of Brexpiprazole for the Acute Treatment of Manic Episodes, With~     or Without Mixed Features, in Subjects with a Diagnosis of Bipolar I Disorder~   "
23616|NCT03257852|"~     The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of~     ASP5094 in patients with rheumatoid arthritis (RA) treated with background methotrexate~     (MTX).~   "
23617|NCT03257839|"~     The SoftVue™ is a whole breast ultrasound system with an automated scanning curvilinear~     ring‐array transducer that employs UST. It is currently cleared under FDA 510(k) K123209 and~     K142517 for use as both a B‐mode ultrasonic breast imaging system and color imaging of~     transmission data (sound speed and attenuation). SoftVue™ is not intended to be used as a~     replacement for screening mammography.~      SoftVue uses non‐ionizing ultrasound energy to generate tomographic image volumes of the~     whole breast. While the patient lays prone on a padded table with one breast comfortably~     submerged in a bath of warm water, a ring‐shaped transducer, 22 cm in diameter, encircles the~     breast and pulses low‐frequency sound waves through the water and into the breast tissue.~     More than 2000 elements in the curvilinear transducer's 360 degree array emit and receive~     ultrasound signals to analyze echoes from the breast anatomy in all directions, from the~     chest wall to the nipple. Not only does SoftVue capture data from the reflection of the sound~     waves off of tissue boundaries and structures within the breast, but because the transducer~     surrounds the whole breast, SoftVue also captures signals that are transmitted through the~     breast. This additional transmission data enhances the visualization of the anatomic~     structure of the breast tissue and is not currently available in any other commercially~     marketed breast ultrasound device.~      This prospective, multicenter, multi‐arm, clinical case collection program is IRB‐approved~     and will be conducted in compliance with Good Clinical Practice, the Declaration of Helsinki~     and all applicable regulatory requirements. Arm 1 aims to collectively enroll up to 17,500~     women at a total of up to 8 clinical sites. The design of this protocol is strictly limited~     to case collection; all investigational and statistical plans for future analyses will be~     prepared and registered separately, if they are applicable to the requirements of FDAAA 801.~      Arm 1 is limited to the cohort of asymptomatic women, with heterogeneously or extremely dense~     breast parenchyma (BI‐RADS breast composition category c or d). Matched triads of 2D digital~     mammography (FFDM), 3D digital mammography (DBT), and SoftVue automated whole breast~     ultrasound (SV)exams, from the same patient, with demographic information and clinical~     outcome data, will be collected during the same screening imaging episode. Ultrasound~     characteristics for all types of lesions, whether they are benign or malignant, will be~     collected, as well as objective and subjective breast density composition data.~      The exams and clinical data accumulated in this prospective case collection (PCC) protocol~     will populate a database from which future investigations may be designed for peer reviewed~     publication, development of user training curriculums, building teaching case, and creating~     new marketing materials for SoftVue.A subset of exams will be sampled from Arm 1 for use in~     ROC Reader Study (protocol DMT‐2015.002), which will be separately registered and is designed~     to evaluate the safety and efficacy of a new screening indication for use of SoftVue™ as an~     adjunct to screening mammography. The results of this ROC Reader Study will be submitted to~     the FDA for their consideration of a PMA application for SoftVue.~   "
23618|NCT03257826|"~     The aim of this study was to investigate the effect of percutaneous kirschner wire in~     management of Congenital Pseudarthrosis of Tibia in children younger than 1 year of age. This~     study was to determine the union rates of congenital pseudarthrosis in children operated~     before 1 year of age to identify growth abnormalities in the affected limb ,including ankle~     valgus,tibia valgus,and shortening.~   "
23619|NCT03257813|"~     Aim: To demonstrate the non-inferiority of the PRO-122 ophthalmic solution manufactured by~     Laboratorios Sophia S.A. de C.V. versus Krytantek Ofteno® ophthalmic solution like~     hypotensive therapy in subjects with primary open angle glaucoma or ocular hypertension.~      Study design: a multicentric, prospective, crossover (2x2), double blind clinical study.~     Sample size: one hundred patients with primary open angle glaucoma or ocular hypertension.~     Patients in the period 1: In the first sequence 60 patients will be assigned to receive the~     ophthalmic solution: Krytantek Ofteno ® (timolol 0.5%%/brimonidine 0.2%/dorzolamide 2%) 1~     drop B.I.D. during 30 days and the second sequence 60 patients will be assigned to receive~     the ophthalmic solution: PRO-122 1 drop B.I.D. during 30 days in the same period. Washout~     period: 20 hours. Patients in the period 2: the pharmacological intervention change to the~     opposite therapy for 30 days~   "
23620|NCT03257800|"~     This interventional double-blind, randomized trial has included120 children of American~     Society of Anesthesiologist (ASA) physical status I or II aged between 1and 8 years of either~     sex, scheduled for outpatient minor surgery under general anesthesia.This study examined~     whether co-induction with ketamine-propofol enhance laryngeal mask airway (LMA) insertion~     conditions and preserve hemodynamic state in patients.~   "
23621|NCT03257787|"~     This study investigates the performance of a new adhesive strip when impacted by output.~   "
23622|NCT03257774|"~     The study investigates the impanct real output has on the adhesion of a new adhesive~   "
23624|NCT03257748|"~     Temporomandibular disorder (TMD) is described as a subgroup of orofacial pain with a set of~     signs and symptoms that involve the temporomandibular joint, masticatory muscles, ears and~     neck. TMD can occur unilaterally or bilaterally and approximately 70% of the population is~     affected with at least one sign. The disorder progresses with orofacial pain, muscle pain~     involving the masticatory and cervical muscles, joint noises (clicks and pops), joint block,~     mandibular dysfunction and headache. The etiology can be abnormal occlusion and/or posture,~     trauma involving local tissues, repetitive microtrauma, parafunctional habits and an increase~     in emotional stress. Studies have demonstrated that phototherapy is an efficient option for~     the treatment of TMD, leading to improvements in pain and orofacial function. The aim of the~     proposed study is to analyze the effects of low-level laser therapy and light-emitting diode~     (LED) therapy on pain and function in patients with TMD. Methods: A randomized, controlled,~     double-blind, clinical trial is proposed, which will involve 80 individuals between 40 and 70~     years of age allocated to either a laser group or LED group submitted to twelve sessions of~     phototherapy. The Research Diagnostic Criteria for TMDs will be used to evaluate all~     participants. Pain will be measured using the visual analog scale. Orofacial function will be~     measured based on maximum vertical mandibular movement and muscle tension (determined through~     palpation of the masseter, temporal, frontal, sternocleidomastoid, suboccipital and trapezius~     muscles). Electromyographic analysis of the masseter and anterior temporal muscles will also~     be performed.~   "
23625|NCT03257735|"~     Primary lung cancer is one of the most common malignancies in China, with 57 percent of~     patients being diagnosed at advanced stage. At present, advanced lung cancer has entered the~     era of precise treatment. So it is very important to determine the gene mutation status of~     the tumor and prescribe drugs at the targets. Liquid biopsy is a suitable alternative when~     tumor tissues are difficult to obtain. Liquid biopsy technique refers to the use of human~     body fluid as a sample source to detect the information of related diseases, including blood,~     urine, saliva and cerebrospinal fluid. It is non-invasive, fast and simple, and can avoid the~     problem of insufficient sample size and support for repeated sampling to continuously monitor~     disease.~      With the increasing incidence of lung cancer and the development of diagnosis and treatment~     technology, the survival period of patients has been extended, and the incidence and~     diagnosis rate of the brain metastasis of lung cancer have increased year by year. The brain~     metastasis of lung cancer is the most common type of brain metastatic tumor. The incidence~     rate is about 40-50%, and the prognosis is poor——the natural median survival period is about~     1-2 months. Because of the impractical intracranial tumor biopsy and very low level of DNA in~     peripheral blood, cerebrospinal fluid, which makes close contact with brain tumors, becomes~     potential available samples. Several studies have shown that genetic testing of cerebrospinal~     fluid is feasible. Therefore, this study aims to test the cerebrospinal fluid, blood and~     tissue by the latest second-generation sequencing technology at different time points, to~     dynamically monitor the gene mutation status of cerebrospinal fluid, blood and tissue, to~     explore the role of cerebrospinal fluid biopsy in the diagnosis and treatment of non-small~     cell lung cancer with brain metastases.~   "
23626|NCT03257722|"~     This is a phase 1b/2 study to determine the safety and effectiveness of the combination of~     pembrolizumab and idelalisib in NSCLC patients whose disease has stopped responding to immune~     therapy. This study is being done to see if adding another immune modulator (idelalisib) to~     standard pembrolizumab will increase response rates, compared to the response seen with~     pembrolizumab alone.~   "
23627|NCT03257709|"~     This study compares two established surgical treatments for acetabular labral tears. Patients~     will be prospectively recruited and randomised to either labral repair or debridement. All~     patients will be followed for 2 years after intervention with a primary outcome assessment at~     6 months.~   "
23628|NCT03257696|"~     Quality of care depends strongly on oral communication with patients. Stroke patients, who~     have language disorders, have understanding difficulties, but also have difficulties in~     expressing their needs and in being understood. Available tools do not allow a professional~     consensus on the assessment of patients' ability to answer reliably to questions asked by~     caregivers. The investigators propose an answer reliability assessment tool based on yes or~     no questions. The goal of the present study is to define an optimal score for defining the~     test positivity, as a compromise between sensitivity and specificity, and by emphasizing the~     negative predictive value.~   "
23629|NCT03257683|"~     The purpose of this study is to collect data to determine if the medication, Ranolazine,~     effects heart muscle function in patients who have areas of non-revascularizable heart~     muscle.~   "
23630|NCT03257670|"~     This trial seeks to determine if therapy with a CO2 laser to the vagina is more effective~     than lidocaine to the opening of the vagina before intercourse to reduce painful intercourse~     in women who are breast cancer survivors. This study will also be looking at whether or not~     the CO2 laser improves pelvic floor function, bowel and bladder function, and sexual function~     before and after treatment.~   "
23631|NCT03257657|"~     Low-income and minority women are at increased risk for postpartum weight retention (i.e.~     retaining weight after pregnancy) and consequent persistent obesity. Women who are obese~     pre-pregnancy are 3-5 times more likely to gain weight, rather than lose weight, in the~     postpartum period than non-obese women. Aims for this pilot study are listed below:~      Aim 1: To evaluate the feasibility and acceptability of a multi-component novel weight loss~     intervention delivered in a WIC setting to a population of low-income, predominantly~     racial/ethnic minority, obese, postpartum women.~      Aim 2: To evaluate differences in weight change, diet, physical activity, self-efficacy,~     readiness to change, motivations to eat between intervention and control participants to~     determine preliminary intervention efficacy over a 12-week period.~   "
23632|NCT03257644|"~     The purpose of this study is to evaluate the safety, tolerability and the pharmacokinetics~     (PK) of topical INCB018424 cream applied to pediatric subjects (age ≥ 12 to 17 years) with~     atopic dermatitis (AD).~   "
23633|NCT03257631|"~     A Phase 2 study that will assess the efficacy, safety and tolerability of pomalidomide in~     children and young adults aged 1 to < 21 years with recurrent or progressive primary brain~     tumors.~      The study will consist of 4 parallel groups, one for each of the following primary brain~     tumor types: high-grade glioma, medulloblastoma, ependymoma and DIPG. A Simon's Optimal~     two-stage study design will be applied to each group.~   "
23634|NCT03257618|"~     Studying QoL in patients DLGG receiving TMZ is complex because of the multiples interactions~     between tumor characteristics, neurocognitive functioning, treatments, environment and~     psychopathological context in which these patients experience symptoms. It is, however,~     important to accurately evaluate these aspects in consideration of the young age, generally~     preserved QoL at the time of diagnosis, possible implications of the disease on the~     professional (DLGG patients are often still active), social and familial domain, and~     relatively long survival of these patients. In the absence of a curative treatment for DLGG,~     preserving patients' QoL is indeed a major goal.~   "
23636|NCT03257592|"~     Many neurological diseases, including AIDS dementia, Alzheimer's disease and schizophrenia,~     involve an inflammatory component thought to specifically involve glial cell activation. The~     Investigators has been concerned with the development of tools for noninvasive imaging of~     inflammatory processes in psychotic disease. Here, the investigators aim to use PET-based~     neuroimaging with carbon-11~     N,N-diethyl-2-(4-methoxyphenyl)-5,7-dimethylpyrazolo[1,5-a]pyrimidine-3-acetamide,~     ([11C]DPA)-713 to quantify regional distribution of translocator protein (TSPO), a putative~     marker of inflammation, in the brains of patients with schizophrenia and bipolar disorder,~     type I. The investigators will focus on patients in the early stages of disease (within first~     five years of onset of schizophrenia diagnosis and within first five years of first manis,~     respectively) to minimize the confounds of age-, chronic illness-, and medication- effects on~     our results.~   "
23637|NCT03257579|"~     Quasi-experimental, controlled interrupted time series design, evaluating the impact of the~     intervention at Hamilton Health Sciences (HHS) where standardized prescriptions and education~     will be provided, St Joseph's Hospital (SJH) where education alone will be provided and~     Niagara Health Services (NHS) sites where education and point of care reminders at discharge~     to promote 90 day prescriptions and 3 repeats, with remaining Ontario cardiac sites as a~     concurrent control group.~   "
23638|NCT03257566|"~     Therefore, for early detection of hypothyroidism in children with type 1 diabetes, it is~     suggested to measure anti-thyroid antibodies and thyroid stimulating hormone at disease onset~     and in yearly intervals after the age of 12 yr. Furthermore, the International Society for~     Pediatric and Adolescent Diabetes Consensus Clinical Guidelines recommend the screening of~     thyroid function by analysing circulating thyroid stimulating hormone at the diagnosis of~     diabetes and, thereafter every 2nd yr. in asymptomatic individuals without goitre and more~     frequent if goitre present .~   "
23639|NCT03257553|"~     Necrotizing enterocolitis continues to be a disease that is associated with significant~     morbidity and mortality in premature infants due to advances in neonatal intensive care that~     increase the survival rate of extremely low birth weight infants (below 1,000 gram)~   "
23640|NCT03257540|"~     The goal of this research study is to determine if union rates are affected by early~     weight-bearing after Lapidus Arthrodesis using the Phantom™ Intramedullary Nail.~      The study hypothesis is that the union rate for those who undergo a Lapidus Arthrodesis~     procedure with the Phantom™ Intramedullary Nail and participate in an early weight-bearing~     protocol will be non-inferior to union rates previously published for this procedure.~   "
23641|NCT03257527|"~     The study is designed to compare the efficacy of two programs intended to improve happiness~     and well-being among healthy, community adults between the ages of 25 and 75 years.~     Participants will complete either an in-person program (ENHANCE) or a mindfulness-based~     stress reduction (MBSR) self-help program over 3-months. The ENHANCE program will include~     12-weekly sessions based on researched principles of happiness. Alternatively, the MBSR~     self-help guide will teach ways to replace stress-promoting habits. Participants will be~     asked to complete a series of measures at three points of the study: at the start of the~     study, the end of the study, and 3-months following the study.~   "
23642|NCT03257514|"~     The aim of this study is to evaluate the efficacy of alpha lipoic acid on uterine scar~     healing after cesarean section by using saline contrast sonohysterography~   "
23643|NCT03257501|"~     This is a non-randomized, single arm, multi-center, prospective, non-significant risk study~     to evaluate the FreeStyle Libre Flash Glucose Monitoring System.~   "
23644|NCT03257488|"~     This study evaluates the utility and reliability of Somnocheck micro Weinmann for obstructive~     sleep apnea syndrome (OSAS) screening in patients affected by resistant systemic arterial~     hypertension. Results are compared with a modified portable sleep apnea testing (type III~     portable monitoring: Somnocheck 2 Weinmann).~   "
23645|NCT03257475|"~     Cervical cancer is the most common malignant in women with the average five-year overall~     survival rate as high as 70%. Radiation therapy is the main treatment for cervical cancer.~     Vagina is one of the important organ at risk and also a target organ in the treatment of~     cervical cancer patients. Vaginal radiation has serious related complications that affect the~     quality of life of patients and therefore needs much clinical attention. But due to lack of~     sufficient evidence, the clinical dose to the vagina is limited. ICRU-89 defined the~     recto-vaginal reference point (R-V) as a reference point for vaginal dose assessment.~     However, the R-V position is affected by applicator placement, vaginal packing and other~     factors hence the dose point only do not represent the entire vaginal radiation dose~     resulting in some clinical limitations. The latest research in Europe proposed that~     PIBS(Posterior-Inferior Border of Symphysis) / PIBS ± 2cm and VRL (vaginal reference length)~     may be more reasonable to use to assess vagina radiation doses, but it remains to be further~     clinically investigated. Therefore, this study intends to perform radical radiotherapy in~     cervical cancer patients and also by recruiting local and foreign hospitals into this study~     by recording its PIBS/ PIBS ± 2cm, VRL, R-V point dose, acute and chronic radiation injury~     incidence of vagina and other useful data. T-test and chi-square will be used to compare the~     data between Asian and European women. Correlation analysis will be used to determine if~     there is a relation between R-V and PIBS point dose. Furthermore, logic and or COX regression~     model to evaluate PIBS / PIBS ± 2cm and R-V point doses of vaginal radiation injury~     relationships, while exploring other relevant factors causing vaginal radiation injury. This~     is eventually expected to provide a scientific, simple and reliable reference point for~     vaginal dose assessment and clinical dose limit.~   "
23646|NCT03257462|"~     This is a multicenter Phase 2, multiple dose, dose escalation study to evaluate the safety,~     pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of SPR001 in adult patients with~     classic congenital adrenal hyperplasia (CAH).~   "
23647|NCT03257449|"~     Abstract:~      Background: Obesity is a global pandemic affects all age groups and is independent risk~     factors for most chronic diseases. Dietary intervention is an essential component of obesity~     management. Dietary fibre supplements have the potential to facilitate weight reduction based~     on their viscosity. Up to date, the evidence of effects of some fibres on weight is~     inadequate, and literature provides insufficient information about the effects of the fibre~     viscosity in weight management.~      Objective: Two systematic reviews and meta-analyses of RCTs will be conducted to evaluate the~     effectiveness of viscous fibres, (agar, alginate, b-glucan from oat and barley, guar gum,~     glucomannan, pectin, PGX, psyllium), on body weight reduction.~      Methods: Only randomised controlled trials are accepted. The trails must have one of the~     selected fibres as a supplement, and the outcomes must have body weight, BMI, waist~     circumference, or body fat percentage. Studies shorter than 4 weeks are excluded. Three~     databases, (Medline, EMBASE, and Cochrane library), were searched through 04/03/2016.~      Results: After removing duplicates, 82 studies will be reviewed in full. Significance: This~     meta-analysis is the first meta-analysis that is based on fibre viscosity, and it will~     quantify the effect of each fibre in improving weight loss. It will also direct future~     research in the best direction to further explore this area.~   "
23649|NCT03257423|"~     Appendicectomy has been the treatment of acute appendicitis for over a hundred years.~     Appendicectomy, however, includes operative and postoperative risks despite being a routine~     procedure. Several studies have proved promising results of the safety and efficiency of~     antibiotics in the treatment of acute uncomplicated appendicitis. The previous APPAC study by~     the investigators, published in 2015 in the Journal of American Medical Association, also~     proved promising results with 73% of patients with uncomplicated appendicitis treated~     successfully with antibiotics. None of the patients initially treated with antibiotics that~     later had appendectomy had major complications. The results of the APPAC trial suggest that~     CT proven uncomplicated acute appendicitis is not a surgical emergency and antibiotic therapy~     is a safe first-line treatment option. Reducing unnecessary appendectomies has also been~     shown to lead to significant economic savings. On the other hand, antibiotic therapies have~     been shown to have an effect on the normal gut microbiota and are considered an increasing~     global health threat underlining the importance of evaluating both short- and long-term~     effects of the antimicrobial treatment in old and new indications.~      The aims of this randomized prospective study are:~        1. To evaluate the possible role and differences in the microbiological etiology of~          complicated and uncomplicated appendicitis.~        2. To determine the effects of both antibiotic and placebo treatment on the composition of~          gut microbiota, and to evaluate how it recovers after the appendicitis-related~          antimicrobial treatment (AMT)~        3. To evaluate the effects of the duration of the hospital stay on the AMR reservoir of the~          gut microbiota.~   "
23650|NCT03257397|"~     Background Major depression is associated with morbidity and increased mortality. Along with~     the psychological strain depression represents a high socioeconomic burden costing Europe~     more than €113 billion/year. About one third of patients do not respond to appropriate~     therapy. Theta-burst stimulation (TBS), a form of transcranial magnetic stimulation is an~     emerging treatment for patients for whom pharmacological treatment is ineffective or not~     appropriate. Based on two different theories of prefrontal dysfunction two TBS-protocols~     should have the most antidepressant effects. However, no study so far has compared the two~     approaches or systematically investigated their differential effects on brain function and on~     a symptom level.~      Objectives of the study The aim of this study is to test two TBS protocols on symptom~     improvement and associated brain function in patients with treatment resistant depression~     (TRD): iTBS over bilateral DLPFC and iTBS over left and cTBS over right DLPFC. As stimulation~     over non-motor regions offers no direct readout, fMRI at baseline and after treatment will be~     harnessed to quantify an effect on brain activity and functional network metrics.~      Study population 80 patients with TRD will be enrolled with 40 patients receiving the one,~     and 40 patients receiving the other TBS protocol for a treatment period of three weeks.~      Study design The study is designed as a longitudinal, randomized and double-blind clinical~     trial. At baseline and after treatment, patients will undergo psychiatric testing using~     several symptom scales including the Hamilton Depression Rating Scale (HAMD-17), the Beck~     Depression Inventory (BDI-II), the Inventory of Depressive Symptomatology (IDS-C) and the~     State-Trait Anxiety Inventory (STAI). Changes in HAMD-17 scores are defined as primary~     endpoint. Moreover MRI scans before and after treatment will include structural and~     functional MRI sequences as well as diffusion weighted imaging (DWI) sequence. Functional~     connectivity and BOLD responses will serve as primary imaging endpoints. A follow-up visit 2~     weeks and a final examination 4 weeks after treatment will elucidate durability of effects.~      Relevance and implications of the study By investigating which approach is superior for which~     symptoms our study will contribute to the development of personalized treatment, the~     reduction of personal suffering and the reduction of costs and occupational disability.~   "
23651|NCT03257384|"~     The primary objective is to prospectively identify Operating Room (OR) time delays from the~     time the patient who is undergoing total laparoscopic hysterectomy enters the OR to exiting~     the OR. This analysis will be used to identify root cause(s) leading to OR delays and define~     areas for improvement. The secondary objective is to identify any improvements in OR time~     delays and OR utilization following implementation of a standardized framework developed to~     increase OR efficiency.~   "
23652|NCT03257371|"~     With IRB approval and informed consent, patients (n=10) (18-50 years old) with post-traumatic~     knee OA and requiring a tibial plateau and meniscus arthroplasty plus a femoral condyle~     arthroplasty will be enrolled in the study. Primary criteria for inclusion will be Grade IV~     changes in the articular cartilage of the femoral condyle and tibial plateau and meniscal~     pathology in the medial or lateral femorotibial joint as determined by physical examination,~     diagnostic imaging and knee arthroscopy by the PI. Exclusion criteria include Grade III or IV~     changes in any other compartment of the knee, acute injury to any other part of the affected~     lower extremity, or inability to comply with the protocol.~      After enrollment, patients will undergo standardized knee radiography, and complete~     assessments (described below). Size-matched (standard clinical methodology) proximal tibia~     with meniscus and distal femur allografts from the same donor will be obtained from a tissue~     bank (Musculoskeletal Transplant Foundation, Edison, NJ) who has licensed the MOPS~     technology. The medial or lateral femoral condyle will be replaced using our novel~     instrumentation and technique described above. Tibial plateau-meniscus grafts will be trimmed~     and used to replace the entire medial or lateral tibial condyle while sparing the attachments~     of ACL, PCL and respective collateral ligament. The tibial plateau graft will be fixated~     using commercial available implants used for bone fixation. In the event that the meniscus~     has been detached from the tibial plateau during graft harvest, the periphery of the meniscus~     will be sutured to the capsule following standard meniscus transplant procedure.~      Patients will undergo controlled post-operative rehabilitation according to standard~     protocols for osteochondral with concurrent meniscus allografts.~      Range of motion, VAS pain score, SF-12, Tegner score, International Knee Documentation~     Committee (IKDC) subjective and objective scores, PROMIS Bank v1.2 - Physical~     Function-Mobility, PROMIS v1.1 - Global Health, PROMIS Bank v1.1- Pain Interference, PROMIS~     Bank v1.2 - Physical Function and Marx score as well as complete radiographs of the affected~     knee will be obtained prior to surgery and at 6 weeks, 3 months, 6 months, and 12 months~     after surgery to evaluate healing, function and evidence for arthrosis.~   "
23653|NCT03257358|"~     A study of immune phenotype biomarkers in patients with Relapsing Multiple Sclerosis (RMS)~     after treatment with 0.5mg fingolimod~   "
23654|NCT03257345|"~     Vedolizumab has been approved for the treatment of both ulcerative colitis and Crohn's~     disease. The aim of this study is to capture the early real life UK experience of vedolizumab~     including the outcomes of treatment, describing the patient population treated, drug~     persistence, IBD control PROM, durable remission, tolerance and safety.~   "
23655|NCT03257332|"~     BACKGROUND: More than a third of patients whom have been diagnosed with rectal cancer and~     treated with curative rectal surgery (low anterior resection) develop faecal incontinence~     also known as the low anterior resection syndrome (LARS). Faecal incontinence is a~     deliberating and stigmatized problem that can lead to impaired quality of life.~      There is limited evidence on efficacy of current treatment strategies for feacal incontinence~     in patients with LARS. Pelvic floor muscle exercise is a simple and non-invasive treatment,~     that has shown preliminary positive effects on faecal incontinence and quality of life.~     Pelvic floor muscle exercise has the potential to be a cost-effective treatment for faecal~     incontinence in subjects with LARS. Despite this, there is limited knowledge about the~     relationship between; severity of faecal incontinence and pelvic floor muscle function. To~     our knowledge no records exist on this relationship within the first 6 months after low~     anterior resection or stoma closure. This type on information is central for future designing~     and conducting of expensive randomized trials.~      PURPOSE: The purpose of the EDFI-Cohort study, is to determine the incidence, prevalence and~     causality of faecal incontinence, quality of life and anorectal muscle function from prior to~     stoma closure to 2 years after stoma closure, in subjects whom have been curatively treated~     for rectal cancer with low anterior resection.~      METHOD: Subjects for the EDFI-Cohort study will be recruited during autumn/winter of 2017 and~     throughout 2018, from Department of Surgery, Slagelse Hospital. Subjects should have received~     curative surgery for rectal cancer (low anterior resection) with/with-out adjuvant~     (radiation/chemo) therapy. Subjects for this study will have been treated with low anterior~     resection (e.g. total mesorectal excision (TME) or partial mesorectal excision (PME)) and~     scheduled for stoma closure. Prior to inclusion subjects must have received study information~     and provided written informed consent to participate in this study.~      Sample size: We need to examine a minimum of 50 subjects per year. With our broad inclusion~     criteria we aim to include a total of 150 subjects during the 1½ year inclusion period.~      Outcomes: Outcomes of patient characteristics (e.g. age, cancer stage and type of surgery)~     will be collected at baseline. Self-reported outcomes (e.g. feacal incontinense, quality of~     life and sexual function) and a clinical examination on anorectal muscle function will be~     collected/performed at prior to stoma closure and 3 weeks, 12 weeks, 6 months, 12 months, 52~     months and 104 months after stoma closure.~      Statistical analysis: The EDFI-Cohort study is expected to be analysed with both multiple~     linear regression and simple linear regression models for the continuous data. In addition we~     plan to dichotomize the LARS-score into no/minor or major LARS, and thus analyses on LARS~     will be handled with binominal tests.~      Patient involvement: Prior to planning of the EDFI-Cohort study, we have performed a single~     case-study (spring 2016) on examination procedure, questionnaires and pelvic floor muscle~     rehabilitation, this case provided us with valuable information on perspective of testing and~     possible evaluation of treatment effect.~      Research ethics: Examinations included in this study are all associated with very few if any~     adverse events, except from the mild discomfort related to the clinical anorectal examination~     itself. Subjects included in this study will receive 6 examinations, whereas care as usual at~     Slagelse hospital usually include one examination/contact to the local LARS clinic with no~     anorectal examination. Included subjects are more closely monitored and, if need be, might~     receive relevant treatment earlier compared to care as usual patients.~      Future implications: Results from the EDFI-Cohort study will help guide the design of~     randomized controlled trials on treatments of faecal incontinence in subjects whom have been~     surgically treated for rectal cancer. With emphasis on establishing the role of anorectal~     muscle function in the development faecal incontinence.~      Applicability of registrations and approvals: Prior to subject inclusion the EDFI-Cohort~     study will need to be approved by the regional research ethics committee of Region of Zealand~     including adhering to Danish legislation on 'processing of personal data'. The data~     protections agency will be notified prior to project start. Finally, the project will prior~     to start be registered at ClinicalTrials.gov.~   "
23667|NCT03257163|"~     This phase II trial studies how well pembrolizumab works with capecitabine and radiation~     therapy in treating patients with mismatch repair deficient and Epstein-Barr virus positive~     gastric cancer. Monoclonal antibodies, such as pembrolizumab may interfere with the ability~     of tumor cells to grow and spread. Drugs used in chemotherapy, such as capecitabine, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Radiation therapy uses high energy~     x-rays to kill tumor cells and shrink tumors. Giving pembrolizumab, capecitabine and~     radiation therapy may work better at treating gastric cancer.~   "
23668|NCT03257150|"~     This I/II study will evaluate to see how safe and useful irreversible electroporation (also~     called NanoKnife) is in patients with locally advanced pancreatic cancer.~   "
23669|NCT03257137|"~     This study will investigate the effect of two dietary patterns on sleep outcomes and measures~     of reported appetite. Participants will be given two different diets on two separate stays.~   "
27300|NCT03209661|"~     Investigating the acute effects of a single use E-Cigarette upon vascular health.~   "
23656|NCT03257319|"~     Prospective single-blind, multicenter, national, randomized, controlled trial in 15 Emergency~     Department to compare two ways of morphine titration. The eligible patient is included~     immediately after his arrival in the Emergency Department, after being questioned by the~     triage nurse about the presence and the intensity of pain, when the VAS is greater than 70~     (or EN>7) and after written consent.~      After installation into the examination room, patient is randomized in one of two parallel~     groups (stratified by sex and center using software) and receives one of the two treatments,~     either inhaled morphine + IV placebo or IV morphine+ inhaled placebo (control group).~      In both groups, titration is defined by a dose of repeated boluses as long as the relief is~     not achieved (VAS> 30 or EN >3) and the criteria to stop titration are not met.~      A 5 minutes time interval between the boluses is chosen. Each aerosol takes 5 minutes at a~     constant air flow, aerosol mask, plastic tubing and PVC transparent tank are used.~      Thus patient receives a maximum of 3 aerosol (one aerosol every 10 minutes) and a maximum of~     6 IV injections (one injection every 5 minutes) The stopping criteria, except pain relief,~     are linked to the occurrence of side effects and specific cares are described into the~     protocol (in case of severe ventilatory depression naloxone titration is provided). Exit~     criteria from the emergency room and from the hospital are defined. An information sheet is~     delivered.~   "
23657|NCT03257306|"~     The specific aim of this study is to validate our hypothesis that the magnetic ureteral~     stents have the same amount of adverse effects as the more commonly used non-magnetic~     ureteral stents. If this hypothesis would be confirmed then the usage of magnetic ureteral~     stents would be justified for both reducing patient discomfort by way of fewer cystoscopies~     and possibly also decreasing the overall expenditures of treatment.~   "
23658|NCT03257293|"~     The goal of this project is to improve patient experience of cystoscopy using a~     non-pharmacologic modification of procedure. Cystoscopy is a common outpatient procedure for~     urology patients and is usually performed without sedation. However, there is limited~     research into reduction of patient discomfort throughout this procedure. The proposed~     modification technique was selected based on a well-documented psychological phenomenon in~     which only particular moments over the course of an aversive event determine the resultant~     perception of the experience. It is hypothesized that implementation of the technique will~     decrease the recalled pain intensity of the cystoscopy.~   "
23659|NCT03257280|"~     This is a prospective randomized controlled clinical trial to clarify the effect of early~     oral nutrition introduction after total gastrectomy in gastric cancer patients on the length~     of hospital stay, comparing an experimental group vs control group.~   "
23660|NCT03257267|"~     The primary objective is to compare overall survival (OS) for patients with recurrent or~     metastatic platinum-refractory cervical cancer treated with either REGN2810 or investigator's~     choice (IC) chemotherapy.~      The secondary objectives are:~        -  To compare progression-free survival (PFS) of REGN2810 versus IC chemotherapy~        -  To compare overall response rate (ORR) (partial response [PR] + complete response [CR])~          of REGN2810 versus IC chemotherapy per Response Evaluation Criteria in Solid Tumors 1.1~        -  To compare the duration of response (DOR) of REGN2810 versus IC chemotherapy~        -  To compare the safety profiles of REGN2810 versus IC chemotherapy by describing adverse~          events (AE)~        -  To compare quality of life (QOL) for patients treated with REGN2810 versus IC~          chemotherapy using the European Organization for Research and Treatment of Cancer~          Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)~   "
23661|NCT03257254|"~     12 month, multicenter, open-label registry to observe chronic venous insufficiency resulting~     in VLU treated with Varithena~   "
23662|NCT03257241|"~     The study will include newly-diagnosed AML patients, not suffering acute promyelocytic~     leukemia; aged 18-60 years, who are eligible for standard induction chemotherapy. The~     patients will be randomized to one standard induction regimen (DAC or DA-90). At day seven~     after completion of induction, a bone marrow aspiration with MRD will be performed for an~     early evaluation of response to treatment. Patients without bone marrow blast reduction below~     10% at day seven after induction will be given a second early induction course. Patients who~     do not achieve CR after two induction courses will be randomized to one of the standard~     salvage regimens (FLAG-IDA or CLAG-M). Postremission treatment intensity will be adjusted to~     risk group based on cytogenetic and molecular risk factors at diagnosis and AML biology~     (secondary AML, therapy related AML). Patients with a low risk of relapse will be allocated~     to consolidation, with three courses of high doses of Ara-C (HiDAC), or two courses of HiDAC~     with subsequent autologous stem cell transplantation. Intermediate- or high-risk patients~     will be referred for allogeneic stem cell transplantation, if they have a matched donor.~     Until transplantation, consolidation with HiDAC will be continued.~   "
23663|NCT03257228|"~     Diabetes mellitus is among the most common chronic diseases, with significant and well~     documented impact on oral cavity health. Among the most common diseases of the oral cavity~     mucosa and complications in patients with impaired glucose metabolism and diabetes mellitus~     is oral lichen ruber (OLR), which according to World Health Organisation (WHO) is considered~     potentially malignant disorder. It was found that lichen ruber in diabetes mellitus has a~     much more aggressive clinical course in the form of atrophic-erosive and ulcerative lesions~     showing an increased tendency to malignant transformation. Although OLR etiology is unknown,~     evidence suggests cell-mediated autoimmune pathogenesis. OLR epithelial cells show anomalies~     in both enzymatic activity and carbohydrate metabolism, which may be related to hormones~     regulating carbohydrate, insulin and insulin-like growth factors 1 and 2 (IGF-1 and IGF-2)~     metabolism. The hypothesis of our research is that patients with diabetes mellitus and oral~     lichen ruber lesions will have a disturbance of insulin-like growth factors 1 and 2 and hence~     a greater risk of malignant transformation, compared to patients with oral lichen ruber~     without diabetes and healthy patients without alterations in the oral mucosa.~   "
23664|NCT03257215|"~     Vitamin D is known to have a regulatory influence on both the immune system and skin barrier~     function. Studies in paediatric populations have found an inverse association of vitamin D~     levels and with both prevalence and severity of atopic dermatitis (AD). Trials of vitamin D~     as a treatment for AD are limited in number and size. There has never been a~     placebo-controlled randomised controlled trial of stoss high dose versus daily standard dose~     for the treatment of AD. Further, no trials have explored the presence of vitamin D pathway~     genes and response to treatment of AD. This pilot study will be used as a reference to~     determine outcomes and feasibility for undertaking a larger and more in depth definitive~     study.~   "
23670|NCT03257124|"~     AZD9291 is an oral potent irreversible EGFR TKI selective for sensitizing EGFR mutation and~     T790M resistance mutation but sparing wild-type EGFR. Preclinical studies indicate that~     AZD9291 has significant exposure in the brain and activity against EGFR mutant brain~     metastasis. In addition, anti-tumor activities of AZD9291 in patients with advanced stage~     EGFR mutant NSCLC including patients with brain metastasis have been reported in an ongoing~     Phase I study. More recently, AZD9291 at a dose of 160mg also showed promising efficacy in~     heavily pre-treated patients with leptomeningeal disease from EGFR mutant NSCLC. Among 11~     evaluable for response, 6 patients had LM imaging improvement and 3 out of 7 patients with~     abnormal neurological exam at baseline had symptomatic improvement. Compared to AZD9291,~     other 3rd generation EGFR TKIs, rociletinib or HM61713 has not been reported to be effective~     in most of CNS disease of NSCLC. Further, previous studies with AZD9291 showed anecdotal case~     series or undetermined for T790M mutation status, indicating more systematic study is~     warranted.~      Based on these data, the investigators are going to conduct phase II study of AZD9291 in~     NSCLC patients harboring T790M mutation who failed EGFR TKIs and brain and/or leptomeningeal~     metastasis.~   "
23671|NCT03257111|"~     Patients admitted to the in-patient rehabilitation center with a diagnosis of stroke will be~     recruited into the study. The participants will wear two activity monitors (one commercial~     grade and one research grade) for the duration of their rehab stay. Data from the monitors~     will be correlated with rehab outcomes, therapy units billed, and length of stay.~   "
23672|NCT03257098|"~     The aim of this clinical trial is to investigate the efficacy (by monitoring the wound size~     reduction of Chronic Venous Ulcers) and safety (by monitoring adverse events) of the~     medicinal product to be studied after one single application on the wound surface in patients~     with Chronic Venous Ulcers.~   "
23673|NCT03257085|"~     Pilot study to compare the impact of following a low-carbohydrate, high-fat diet versus~     following a high-carbohydrates, moderate-fat diet (UK dietary guidelines) on cardiometabolic~     risk markers and associated behaviours in a normal-weight and overweight adult population.~   "
23674|NCT03257072|"~     Twenty-four healthy hookworm-naive volunteers will be exposed to 50 L3 Necator americanus~     larvae for a maximum of three times.~   "
23675|NCT03257059|"~     The aim of this study is to determine whether eating breakfast or having no breakfast has~     subsequent beneficial health effects, specifically in relation to glycemic response~     throughout the day and postprandial insulin and non-esterified fatty acids (NEFA) responses 6~     hours after breakfast/lunch.~   "
23676|NCT03257046|"~     This is a Phase I/II randomized, double-blind, placebo-controlled, multiple rising dose study~     in patients with stable idiopathic Parkinson's disease (PD) to evaluate the safety,~     tolerability, pharmacokinetics and pharmacodynamics of ITI-214.~   "
23677|NCT03257033|"~     The study is a multi-center, un-blinded, randomized control study of subjects with locally~     advanced pancreatic adenocarcinoma which is unresectable.~   "
23678|NCT03257020|"~     This study evaluates the relationship between BMO-MRW and RNFL thickness measured by OCT.~     SD-OCT exam will be performed to all patients in this study.~   "
23679|NCT03257007|"~     The MEANING trial is a randomized controlled mixed methods pilot designed to compare a novel~     mindfulness meditation-based intervention (MEANING) to usual care for adults with~     advanced-stage solid malignancies and their family caregivers.~   "
23680|NCT03256994|"~     Selective Internal Radiation Therapy (SIRT), also known as radioembolisation, is a minimal~     invasive, endovascular treatment for primary and secondary liver tumours. In France,~     SIR-Spheres are listed as reimbursable by the national health authorities (Haute Autorité de~     Santé [HAS]). In order to evaluate the reimbursement after five years, all patients treated~     with SIR-Spheres will be entered into a registry that collects data on the real-life clinical~     application of SIRT and reports to the national authorities.~   "
23681|NCT03256981|"~     HALT is a phase II, randomised multi-centre study with integrated seamless continuation to~     phase III trial following acceptable safety and feasibility assessment.~      HALT aims to recruit 110 patients with mutation positive advanced NSCLC with oligoprogressive~     disease (OPD) following initial response to a Tyrosine Kinase Inhibitor (TKI).~   "
23682|NCT03256968|"~     The purpose of this study is to explore the combination of ataluren and ivacaftor as a~     treatment for patients with nonsense mutation cystic fibrosis~   "
23683|NCT03256955|"~     Neuromuscular blocking agents (NMBAs) are frequently used in anesthesia and quantitative~     neuromuscular monitoring is standard care. The TOF WATCH SX® monitor is considered as one of~     the reference monitoring devices in clinical research and clinical practice. With this~     monitor the ulnar nerve is stimulated at the wrist and the force of the movement of the thumb~     is measured with acceleromyography. This method requires freedom of movement of the patient's~     thumb. Unfortunately this is not always possible due to the constraints of patient~     positioning during the operation. The TOF Cuff® monitor is a modified non-invasive blood~     pressure cuff that incorporates stimulating electrodes in its inner surface and is based on~     the stimulation of the peripheral nerve in the arm (brachial plexus, ulnar and median nerves~     principally). The evoked neuromuscular activity is recorded through the changes in pressure~     generated in the inner part of the cuff by the muscular activity after the stimulus.~     Moreover, this device can be used for non-invasive reading of the blood pressure. This device~     has been validated with mechanomyography, but was never been compared with acceleromyography,~     which is the most common used neuromuscular monitoring method.~   "
23684|NCT03256942|"~     Primary objective:~      - To evaluate the sensitivity of the Merz Lip Fullness Assessment Scale (MLFAS).~      Secondary objectives:~        -  To evaluate the clinical aesthetic improvement outcome in lips appearance four weeks~          after Etermis 4® injection.~        -  To evaluate safety/tolerability of Etermis 4® treatment in lips.~   "
23698|NCT03256760|"~     Late-life depression is a significant public health concern, and effective interventions for~     prevention and treatment are needed. Insomnia and inflammation are modifiable targets for~     depression prevention, and this study is significant in using an experimental approach (i.e.,~     inflammatory challenge) to probe acute inflammatory- and depression responses as a function~     of insomnia, which will inform identification of molecular targets for pharmacologic~     interventions, and improvement of insomnia treatments to prevent depression in older adults.~      Project~   "
23685|NCT03256929|"~     The propose of the study is a multi-disciplinary project connecting nutritional and health~     sciences with social and behavioral sciences, and aimed at understanding the microbiota~     changes related to the third age and their effects on mood and mental health. The research~     aims are primarily practical: They will explore the influence of the gut flora on depression,~     which could help us to recommend diets that might reduce the risk of developing depression.~     The novelty of this proposal is in the design of personalized diet-driven microbiota~     alterations and health status to modulate depression in elderly. For the first time the~     improvement of mental health in the elderly will be studied through a nutritional and food~     habits approach based on microbiota changes upon ageing.~   "
23686|NCT03256916|"~     The primary aim of the trial is to study the impact of nelfinavir on 3 year disease free~     survival in patients with advanced carcinoma of cervix receiving standard chemoradiation~     (Cisplatin and Radiotherapy).~      There will be two study groups. One group will receive standard treatment (concurrent~     chemoradiation and brachytherapy) & other group will receive nelfinavir 5-7 days prior to~     standard treatment (chemoradiation & brachytherapy).~   "
23687|NCT03256903|"~     Clinical trial to compare pain relief between methoxyflurane and any analgesic treatment used~     in usual clinical practice, in patients with trauma and associated pain, treated in Spanish~     emergency units.~   "
23688|NCT03256890|"~     The primary aim is to evaluate impacts of a behavioral intervention called Mindfulness-Based~     Blood Pressure Reduction (MB-BP) vs. enhanced usual care control on systolic blood pressure~     at 6 months, via a randomized controlled trial.~   "
23689|NCT03256877|"~     To validate ELISAs for the detection of urinary tissue factor (TF) in patients suspected of~     having bladder cancer.~   "
23690|NCT03256864|"~     It has been identified that nonadherence to immunosuppressant regimen may cause long-term~     graft failure and death in solid organ transplant recipients. Therefore, simplification of~     the immunosuppression regimen by reducing daily dosing frequency may improve long-term~     outcome. The investigators will examine pharmacokinetics and safety profiles of stable liver~     transplant recipients receiving twice-daily TAC with EVR (BID) regimen and then being~     converted to once-daily TAC with EVR (QD) regimen over a 6-month study period~     post-conversion.~   "
23691|NCT03256851|"~     Multiple sclerosis (MS) is a progressive demyelinating disorder that damages white matter in~     the central nervous system. Although individuals experience mobility (e.g., walking, balance)~     impairments that lower quality of life and limit participation in daily activities, one of~     the most prominent symptoms is fatigue. Up to 92% of individuals report fatigue that~     manifests as lack of energy, exhaustion or worsening of MS symptoms and ultimately~     contributes to increasing disability. The currently available pharmaceutical treatments fail~     to fully control fatigue in the majority of individuals with MS; non-pharmacologic therapies~     such as exercise and behavioral therapies offer the best hope for combating MS fatigue in the~     majority of individuals.~      Exercise therapy is effective in reducing MS fatigue. However, access to exercise therapy is~     seriously limited for many individuals with MS due to geographical location, limited~     resources (e.g., financial, transportation), and/or disability. Thus, the development and~     evaluation of an alternative delivery method for exercise therapy to target MS-related~     fatigue that increases participation and reduces barriers is critical.~      In this study, the investigators will compare traditional in-person delivered exercise~     therapy to telephone-delivered exercise therapy to target fatigue in persons with MS.~   "
23692|NCT03256838|"~     To assess the long-term safety and effectiveness of Nephoxil® for the treatment of~     hyperphosphatemia in patients with ESRD undergoing dialysis.~   "
23693|NCT03256825|"~     The study aims to assess the accuracy and impact of rapid diagnosis and rapid diagnosis~     decision support on different aspects of antibiotic consumption when implemented alone or~     together.~   "
23694|NCT03256812|"~     To compare the efficacy and stability of an ICT-based centralized clinical trial monitoring~     system against the efficacy and stability of an existing outpatient-based electrocardiogram~     (ECG) and Holter monitoring system for arrhythmia detection after atrial fibrillation~     ablation, and to test whether such continuous monitoring can better detect arrhythmia that is~     undetectable by existing methods and how this may affect treatment outcomes~   "
23695|NCT03256799|"~     The purpose of this study is to explore the combination of ataluren and ivacaftor as a~     treatment for patients with a specific cystic fibrosis mutation~   "
23696|NCT03256786|"~     The majority of women (> 60%) developed hypothermia and shivering during cesarean delivery.~     Core hypothermia may be associated with a number of adverse outcomes in patients, including~     shivering, wound infection, coagulopathy, increased blood loss and transfusion requirements,~     decreased metabolism and prolonged recovery. Shivering can result in interference with~     monitoring, increased tension on wound edges, and increased oxygen consumption.~      A previous study has shown several modalities to prevent hypothermia and shivering in~     patients undergoing cesarean delivery with spinal anesthesia. But, single modality~     intervention have shown marginal or no efficacy.~      Neuraxial anesthesia reduces the threshold for vasoconstriction and shivering. It often also~     produces a lower body sympathectomy that provokes a core to peripheral redistribution of body~     heat. It is difficult to treat the core to peripheral redistribution of body heat. However~     redistribution can be prevented by preanesthetic cutaneous warming. Prewarming hardly changes~     core temperature that remains well regulated, but it markedly increases peripheral tissue~     heat content. As a result, prewarming reduces the core to peripheral tissue temperature~     gradient and the propensity for redistribution after the induction of anesthesia.~      We therefore hypothesized that Combined modality active warming consisting of preoperative 15~     min of surface warming using a forced air warmer before spinal anesthesia and coloading of~     warmed intravenous fluid might reduce perioperative hypothermia and shivering in women~     undergoing cesarean delivery. Additionally, We tested the hypothesis that maintaining~     maternal normothermia increases newborn temperature and Apgar scores.~   "
23697|NCT03256773|"~     The purpose of this study is to learn about using the imaging to make images of the lungs and~     nose with the long-term goal of the research leading to potential treatments and new~     therapies for patients with cystic fibrosis.~   "
23712|NCT03256578|"~     This is a randomized trial to determine if a visible respiratory function monitor (RFM)~     displaying realtime measurements of delivered inflations improves clinical providers ability~     to perform positive pressure ventilation (PPV) within a pre-defined target tidal volume in~     preterm infants after birth.~   "
23699|NCT03256747|"~     In patients with type 2 diabetes mellitus (T2DM) chronic hyperglycemia is the main cause of~     complications, promoting several micro and macrovascular damages. In order to understand~     other mechanisms that could have an impact on the development of these diabetic~     complications, the assessment of glycemic variability have been widely used. Glucose control~     can be achieved with multiple interventions, including exercise training. Some individuals,~     however, especially those with autonomic neuropathy, can have exercise intolerance. In this~     context, physical therapy proposes neuromuscular electrical stimulation (NMES) as a~     therapeutic that has been applied in research and clinical practice as an alternative to the~     training of patients who cannot perform conventional exercise. In patients with T2DM, NMES~     was shown to improve glycemic control and insulin sensitivity, but quality of these trials is~     poor. In addition, the effects of NMES on glycemic variability of T2DM patients have not yet~     been reported. The aim of this study is to evaluate the effects of NMES on glucose levels and~     glucose variability in patients with T2DM.~   "
23700|NCT03256734|"~     Unplanned hospital readmissions are associated with increases in morbidity, mortality, cost~     and patient dissatisfaction,. Policymakers continue to seek effective policy solutions to~     avoid readmissions in order to improve quality of care and reduce unnecessary expenditures,.~     One attempt to reduce readmissions was implemented on June 1 2012, when the Specialist~     Services Committee of British Columbia (a partnership of Doctors of BC and the Ministry of~     Health) introduced the new G78717 fee code for physicians. The objective of the fee code~     was to create a financial incentive for physicians to provide a point-of-care supplemental~     discharge summary to patients and their primary care providers prior to discharge from~     hospital. Initially, only urgent hospital admissions were eligible for this incentive payment~     but on Nov 1 2015 the incentive was extended to include elective admissions as well. The~     other eligibility criteria remained unchanged.~      The effectiveness and cost-effectiveness of the fee code intervention is unknown. This study~     will address important questions relevant to this policy intervention using rigorous methods~     and empirical data.~      This study will employ two methods for measuring changes in readmission risk. First, we will~     use interrupted (multivariate) time series to measure whether there was a temporal change in~     provincial readmission risk associated with the implementation of the new fee code.~      We will complement the above analyses with a stronger design, comparing hospitalizations for~     which the fee code was charged (intervention group) with a cohort of clinically similar~     hospitalizations for which the fee code was not charged (control group). For this approach,~     multivariate logistic regression will be the primary statistical method. Using this analytic~     strategy, 30-day readmission risk between the intervention and control group will be measured~     over time, adjusted for patient-, provider-, and hospitalization-level covariates.~   "
23701|NCT03256721|"~     Apatinib, a novel targeted inhibitor of VEGF receptor 2 (VEGFR2), shows significant antitumor~     activity in the patients with GC. The purpose of this study is to determine whether apatinib~     plus chemotherapy drug can improve progression free survival compared with chemotherapy drug~     in patients with metastatic the non-small cell lung cancer who failed one lines of~     chemotherapy.~   "
23702|NCT03256708|"~     Prolardii contains intestinal bacteria, a yeast, a fructo-oligosaccharide and a plant extract~     that can contribute to the intestinal comfort. This product could prevent the diarrhea which~     sometimes occurs when the patient has to take antibiotics.~      A total of 220 patients being prescribed antibiotics by general practitioners will be~     included in the study and randomized into a Prolardii arm and a placebo arm.~      The primary endpoint will be the overall frequency of diarrhea in the two treatment groups.~     Acute diarrhea will be defined as the presence of three or more abnormally loose or watery~     stools per day.~   "
23703|NCT03256695|"~     This is a 12-week, multicenter, open-label study to evaluate the relationship between~     as-needed usage of ABS eMDPI and Clinical Exacerbation-Chronic Obstructive Pulmonary Disease~     (moderate CE-COPD)/severe CE-COPD in adult patients at least 40 years of age with~     exacerbation-prone COPD.~   "
23704|NCT03256682|"~     The purpose of this study is to verify the effectiveness of mobile video counseling for~     workers. Subjects who can participate in the screening evaluation are assigned to one of~     face-to-face counseling group, mobile counseling group, and self-treatment group. The mobile~     counseling group and the face-to-face counseling group counseld with a total of 4 times, 50~     minutes at a time, once a week, and the self-treatment group provides self-education by~     providing the stress education kit.~   "
23705|NCT03256669|"~     Abdominal exploration leave an ugly scar that live with the baby forever, laparoscopy can~     solve the problem to some extent by making a smaller scar but takes more time and need~     special surgical skills. Umbilical incision can combine the advantage of open and laparoscopy~     and avoid the drawbacks of both.~   "
23706|NCT03256656|"~     In previous studies, in which the perception threshold and / or sensory evoked potentials at~     different points of the lower urinary tract were examined and measured by means of electrical~     stimulation, a clear increase in the volume of the bladder and thus the urine excretion under~     the stimulation could be observed. This observation is now to be investigated more closely in~     a separate study, in order to strengthen the observation with further measured data and to~     find possible physiological connections. A detectable influence of electrical stimulation in~     the lower urinary tract on renal urine production would have a significant relevance both~     therapeutically and for the neurophysiological understanding of interactions between the~     lower and upper urinary tracts.~   "
23707|NCT03256643|"~     The purpose of this study is to determine whether exercise or exercise with enrichment is~     beneficial in individuals who previously had a head injury. The enrichment will consist of a~     cultural educational program that will include ethnic food, music, slides and a talk. A~     series of tests that measure mental function and balance will be done before and after the~     exercise or the exercise/enrichment program will be done to measure efficacy.~   "
23708|NCT03256630|"~     A Laboratory Study to Evaluate Urine and Blood Biomarkers That Can Distinguish Between the~     Presence or Absence of Aggressive Prostate Cancer~   "
23709|NCT03256617|"~     The focus of this proposal is to evaluate the feasibility of a cognitive reassurance training~     program by examining changes in physical therapist low back pain beliefs and skills with~     training and evaluating the quality with which physical therapists apply cognitive~     reassurance to patients. The secondary focus is to examine the association between physical~     therapist application of cognitive reassurance and short-term changes in patients' low back~     pain beliefs and expectations.~   "
23710|NCT03256604|"~     In patients with clinical symptoms of respiratory infection, rapid identification of cases~     requiring antibiotic therapy is crucial to avoid development of multiple resistant bacteria.~     Identification of local acute-phase reactants can help assess the host's response to~     bacterial infection at the injury site. Here, the investigators developed an affordable,~     stable, feasible, and accurate diagnostic tool based on a locally produced protein with~     specific binding affinity to polysaccharides. The investigators further evaluated the ability~     of the novel test strip to rule out pneumonia.~   "
23713|NCT03256565|"~     Urethral hypermobility, which can be assessed with Q-tip test, has been considered to be~     partly responsible for pathogenesis of women with stress urinary incontinence (SUI).~     Nonetheless, Q-tip test has lost favor due to patient discomfort. Thus, the purpose of this~     study was to search a surrogate for assessment of urethral hypermobility by correlating the~     Q-tip angle and the urodynamic variables in women with SUI.~   "
23714|NCT03256552|"~     The overall objective of this study was to assess the efficacy and safety of GP MDI relative~     to placebo in Japanese subjects with moderate to severe COPD. Each subject received the 4~     separate study treatments, scheduled as four, 7-day, treatment periods for a total treatment~     duration of 28 days.~   "
23715|NCT03256539|"~     This study aimed to pilot test a non-pharmacological (behavioral) treatment program targeting~     improved cognition through improving 24-h sleep-wake cycle in people with mild cognitive~     impairment (MCI) or mild Alzheimer's disease. A treatment program incorporating bright light~     therapy and a modified cognitive behavioral therapy for insomnia will be developed to address~     24-hour patterns of sleep. We will then pilot test its feasibility and explore its~     preliminary effects on improving sleep/napping and cognition in patients with MCI or mild~     Alzheimer's disease.~   "
23716|NCT03256526|"~     IN THIS PHASE 2A, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, 3 ARM, PARALLEL- GROUP STUDY,~     SAFETY, TOLERABILITY, AND PHARMACODYNAMICS OF PF-06835919 ADMINISTERED ONCE DAILY FOR 6 WEEKS~     WILL BE ASSESSED IN ADULTS WITH NONALCOHOLIC FATTY LIVER DISEASE~   "
23717|NCT03256513|"~     Objective: Referring The relation between CEA(Carotid endarterectomy) postoperative blood~     flow monitoring and blood pressure, and combining patient demographics and preoperative risk~     factors to establish an applicable individual blood pressure controlling model. By comparing~     with routine antihypertensive strategies through prospective randomized controlled trials ,~     to provide the best perioperative blood pressure control standards and strategies for each~     patient ,thus better ensuring the safety and efficacy of CEA .~   "
23718|NCT03256500|"~     Delirium is induced by changes in cortical excitability and transcranial direct current~     stimulation (tDCS), by using weak electrical fields, can modulate cortical excitability and~     spontaneous firing activities in the stimulated region by shifting the resting membrane. One~     half of the subjects will receive stimulation via tDCS and the other half will receive sham~     tDCS for 20 minutes per day, 5 days per week, for 1 week. Symptoms will be monitored using~     the Confusion Assessment Method.~   "
23719|NCT03256487|"~     This study evaluates intravenous (IV) buprenorphine versus IV morphine for the management of~     severe, acute pain among emergency department (ED) patients. ED patients with severe pain~     will be randomized in equal proportion to receive IV buprenorphine or IV morphine.~   "
23720|NCT03256474|"~     Retrospective cohort analysis of children hospitalized for pneumonia comparing disease~     severity on admission, clinical course, treatment and outcomes and prospective telephone~     based Follow-Up assessement.~   "
23721|NCT03256461|"~     Serum lactate level is depended on the balance between lactate production and clearance. It~     is seen as a sensitive indicator reflecting not only the low systemic perfusion but~     microcirculatory dysfunction which cause global or regional tissue hypoxia (as a result of~     impaired mitochondrial oxidation). 2016 Surviving Sepsis Campaign guideline stated We~     suggest guiding resuscitation to normalize lactate in patients with elevated lactate levels~     as a marker of tissue hypoperfusion, with weak recommendation and low quality of evidence.~     Several trials which evaluated the resuscitation strategy included lactate clearance as a~     target while based on 2.0 diagnostic criteria for sepsis, finally showed conflicting results.~     The aim of this study is to explore the feasibility of lactate clearance guide resuscitation~     in sepsis that defined by The Third International Consensus Definitions for Sepsis and Septic~     shock through multi-center, central-randomization clinical trial.~   "
23722|NCT03256435|"~     Innovative and novel HIV prevention interventions are urgently needed for African American~     (AA) young men who have sex with men (YMSM) in the South, and in Mississippi in particular.~     HIV pre-exposure prophylaxis (PrEP) is a newer HIV prevention strategy that consists of a~     daily oral antiretroviral pill taken on an ongoing basis by HIV-uninfected but at-risk~     individuals. Although acceptability studies have demonstrated high interested in PrEP in the~     US, uptake remains limited. To date, studies of PrEP initiation have largely been limited to~     settings in which PrEP is provided free of charge. Barriers to PrEP initiation and retention~     in PrEP care in real world settings are likely more complex, since payment for PrEP can be a~     substantial financial burden.~      The ADAPT_ITT approach (an approach to adapting behavioral interventions to new populations:~     Assessment, Decision, Administration, Production, Topical Experts - Integration, Training,~     Testing) will be used to develop and pilot test a RAMP (Retain African American Men in PrEP)~     intervention that aims to promote PrEP adherence and retention in care in Jackson, MS and~     focuses on recruiting AA YMSM in a city with some of the highest HIV infection rates in the~     country. This study will include formative research to understand the cultural and social~     contexts that influence AA YMSM's PrEP use patterns and the acceptability of our proposed~     intervention. Results from these qualitative interviews will inform the study intervention~     which will be tested and refined in a dynamic open pilot evaluation.~   "
23723|NCT03256422|"~     The trial is an open-label, multicenter, prospective, randomized trial in 2 parallel groups,~     evaluating at W48, the non-inferiority of antiretroviral treatment taken 4 consecutive days a~     week versus continuous therapy, in HIV infected patients with controlled viral load for at~     least 12 months and stable antiretroviral treatment since 4 months.~   "
23748|NCT03256097|"~     The study aims to compare two different cochlear implant sound processing strategies. All the~     participants will start off with a sound processing strategy called the XDP (extended~     performance). At the 3 month stage, half of the participants would randomly be selected and~     offered a sound processing strategy called the Voice Guard. Following that, the sound~     processing strategies will be altered and evaluated every 3 months at the 6th, 9th and 12th~     month of cochlear implant use.~   "
23749|NCT03256084|"~     Prospective research of circulating tumor cells as markers of progression risk in colorectal~     cancer.~   "
23750|NCT03256071|"~     The purpose of this prospective, open-label, randomized multicenter study is to evaluate the~     safety and efficacy of low dose decitabine in combination with modified BUCY vs modified BUCY~     as a myeloablative conditioning regimen for high-risk patients with acute myeloid leukemia~     (AML) undergoing allogeneic hematopoietic stem cell transplantation (Allo-HSCT).~   "
23724|NCT03256409|"~     The aim of the study was to compare the surface roughness (Ra) of the implant retained~     mandibular bar overdenture (BOD) and the implant retained mandibular ball joint overdenture~     (BJOD) in jaw and its relation with the adhesion of molds and yeasts and mesophyll aerobe, in~     time 30 to 180 days in mouth. Five systems titanium bar CARES® and synOcta® Straumann® Dental~     Implant System, Holding AG Inc., Basel, Switzerland (BOD); and five systems joint ball~     Klockner® Implant System; Soadco Inc., Escaldes-Engordany; Andorra (BJOD), were used in two~     parallel groups of five participants, in an essay to simple blind person. To 30 to 180 days~     they were withdrawn and they were evaluated the Ra (Mitutoyo Surfest SJ-301® Mitutoyo~     Corporation Inc., Kanagawa, Japan) and the adhesion of microorganisms (CFU/ml).~      The Ra:um (the 30th and 180th): BOD, 0.965 - 1.351; BJOD, 1.325 - 2.384. Adhesion: molds and~     yeasts, BOD, 2.6 x 102 and 4.6 x 103; BJOD, 3.0 x 102 and 5.3 x 104. Adhesion: mesophyll~     aerobe, BOD, 3.8 x 106 and 5.8 x 106; BJOD, 4.3 x 106 and 7.1 x 107. The BOD and BJOD,~     present different Ra (P < 0.05) to 30 to 180 days. To 30 days (P = 0.489) differences do not~     exist as regards the adhesion of molds and yeasts and mesophyll aerobe between both~     overdentures. To 180 days (P = 0.723) differences exist as regards the adhesion of mold and~     yeast and mesophyll aerobe, being major in BJOD.~   "
23725|NCT03256396|"~     The creation of pneumoperitoneum during laparoscopic surgery can have significant effects on~     the respiratory system including decreased respiratory system compliance, decreased vital~     capacity and functional residual capacity and atelectasis formation. Intraoperative~     mechanical ventilation, especially setting of positive end-expiratory pressure (PEEP) has an~     important role in respiratory management during laparoscopic surgery. The aim of this study~     is to determine whether setting of PEEP guided by measurement of pleural pressure would~     improve oxygenation and respiratory system compliance during laparoscopic surgery.~   "
23726|NCT03256383|"~     This study is to supplement our internal data that demonstrates the continued performance of~     capillary blood samples on Magellan's lead testing systems: LeadCare II, LeadCare Ultra~     (which have been cleared previously by FDA), and PediaStat, which is an upgraded LeadCare II~     instrument in development.~   "
23727|NCT03256370|"~     Compare the HMO composition in breast milk of infants with allergic manifestation (atopic~     dermatitis and food allergy) in the first 3 years of life, healthy infants with allergic~     mother and healthy infants with non-allergic mother.~   "
23728|NCT03256357|"~     A randomized, controlled, and evaluator-blinded trail will be carried out comparing CIMT with~     or without AOT on sensorimotor outcome in children with unilateral CP aged 5 to 12 years.~     Additionally the potential role of neurological factors, including the anatomical~     characterization of the brain lesion, structural/functional connectivity and cortical~     reorganization, on treatment response will be investigated.~   "
23729|NCT03256344|"~     Up to 36 subjects will be enrolled in this study. The locations of the study will be in the~     United States, Australia, Europe and Switzerland.~      The goal of this study is to evaluate the safety of intrahepatic injection (directly into the~     liver) of talimogene laherparepvec in combination with intravenously administered~     atezolizumab in subjects with triple negative breast cancer and colorectal cancer with liver~     metastases.~   "
23730|NCT03256331|"~     This is a Phase I, open-label, uncontrolled, multicenter dose escalation and extension study~     to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), to evaluate~     safety / tolerability and preliminary effects of BEL-X-HG in patients with advanced~     refractory solid tumors. Dose escalation during the study will be made based on dose-limiting~     toxicity (DLT).~   "
23731|NCT03256318|"~     Ten year longitudinal survey following children who have participated in CKRI Sports and~     Recreation from a young age (5 to 8), and the parents of children who have participated in~     CKRI Sports and Recreation at a young age (5 to 8). These children will be followed for 10~     years with surveys every 6 months, whether they are currently participating in sports and~     recreation activities or not.~      The purpose of this longitudinal study is to examine the effects of early participation in~     organized sports and recreation activities (S&R) on self-reported health and health-related~     quality of life of children and youth (C&Y) with disabilities and their parent-reported~     social participation. This project will examine child and parent reported differences~     between:~        1. C&Y who participate in CKRI S&R and those who have discontinued participation in CKRI~          S&R programs~        2. C&Y who participate in sports vs. those who participate in recreation, and~        3. C&Y who participate in CKRI S&R and normative data on C&Y with disabilities and those~          without disabilities.~   "
23732|NCT03256305|"~     This is a multicenter, randomized trial aims to reveal the efficacy and safety of Repetitive~     transcranial magnetic stimulation (rTMS) individualized therapy based on the 'emotional loop~     destabilization' mechanism of PSD .One hundred and twenty participants will be recruited from~     three centers and randomized with a 1:1 ratio to receive Personalized rTMS treatment or~     traditional rTMS treatment in addition to routine antidepressant treatments.The data of~     neuropsychological tests and MRI will be collected at 0, 2，4 and 8 weeks after the~     commencement of the treatment.~   "
23733|NCT03256292|"~     Older hypogonadal obese veterans previously participated in a 6 month lifestyle change~     (diet-induced weight loss and exercise) study with or without testosterone replacement~     therapy before being followed for the following year at the clinic while receiving standard~     of care consisting of diet and exercise counseling (for healthy lifestyle change) and~     testosterone replacement therapy. This study will determine if long-term lifestyle change and~     testosterone replacement therapy with associated improvement in physical and metabolic health~     can be maintained in obese older adults.~   "
23751|NCT03256058|"~     This is a randomized controlled trial designed to research the effects of different~     tourniquet applications on postoperative pain in patients undergoing total knee arthroplasty,~     and to guide early postoperative recovery.~   "
23827|NCT03255070|"~     This is a 2-part, Phase 1, open-label study. Phase 1a of this study is designed to determine~     the recommended Phase 2 dose (RP2D) in subjects with advanced cancer whose HER2 test results~     are in situ hybridization (ISH) positive or immunohistochemistry (IHC) 3+ and Phase 1b is~     designed to assess anticancer activity and safety in 2 advanced breast cancer expansion~     cohorts: 1) for tumors that test as HER2 ISH positive or IHC3+ and, 2) for tumors that test~     as HER2 ISH negative with IHC 2+.~   "
23734|NCT03256279|"~     Objective: to compare the changes of the mechanical properties measured by tensile test and~     three point bending test of two NiTi archwires (heat-activated and superelastic); when~     exposed to the oral conditions during the first three months of orthodontic treatment and to~     evaluated their clinical efficacy in lower arch crowding resolution in the anterior~     mandibular arch.~      Methods: Randomized clinical trial in 54 orthodontic patients with moderate crowding. They~     are going to be randomly assigned in to two intervention groups, each group with 27 patients.~     One group are going to be treated with heat-activated NiTi archwires and the other group with~     superelastic NiTi archwires. The patients are going to be followed up for three months and~     cast models will be taken every month. Measures of anterior lower arch crowding resolution~     are going to be taken by previously-calibrated operators. Six archwires of each group will be~     chosen at random and will have tensile test and three-point bending test and the mechanical~     properties are going to measure before and after its clinical use. The outcomes are going to~     be determined and compared between groups, with correspondent statistical test and the~     results are going to be analyzed.~   "
23735|NCT03256266|"~     The study evaluates the effect of nutrient antigens or therapeutic agents on human small~     intestinal organoids.~   "
23736|NCT03256253|"~     The proposed protocol is an 8 week open label outpatient pilot trial of the safety and~     efficacy of pregabalin (Lyrica) in the treatment of alcohol use disorder. The primary~     objective of the study is to determine the efficacy of pregabalin in promoting alcohol~     abstinence among individuals with an alcohol use disorder.~   "
23737|NCT03256240|"~     This study proposes a randomized prospective study comparing the Kono-S anastomosis to the~     standard side-to-side anastomosis.This will be a multi-center randomized prospective trial.~     Patients with Crohn's ileitis or Crohn's ileocolitis requiring resection will be randomized~     to undergo either the Kono-S anastomosis or the side-to-side functional end anastomosis.~   "
23738|NCT03256227|"~     Evidence-based psychotherapies (EBP) for PTSD, such as Prolonged Exposure (PE), result in~     clinically significant symptom relief for many. Yet, adherence to this treatment (i.e.,~     session attendance and homework compliance), which is vital to ensuring recovery, can be~     poor. This project will test the effectiveness of improving family support for PE as a tool~     to improve Veterans' PE adherence. Reducing rates of dropout from PE will positively impact~     Veterans' health and well-being and lower the cost of treating PTSD. Additionally, despite~     congressional legislation and national mandates within VA/DoD for family involvement in PTSD~     care, there remains no proven strategies for how to routinely include family in traditional~     individual (i.e., one-on-one) EBPs for PTSD. This proposal will provide the initial test of a~     model of family engagement that can be translated to other problems faced by Veterans,~     including suicide prevention, traumatic brain injury (TBI) rehabilitation, and pain~     management, contributing to a broader evolution towards evidence-based, family-inclusive~     care.~   "
23739|NCT03256214|"~     Seventy-one patients in intensive care were randomized for initial treatment with open~     suction systems or closed suction systems in a cross-over design. Pulmonary and~     cardiovascular physiology was assessed immediately before and after three 10-second~     aspirations per suction. Were analyzed the effect of each suction system on physiologic~     parameters while adjusting for their respective values prior to suction.~   "
23740|NCT03256201|"~     This is a blinded pilot study in which patients scheduled for pancreaticoduodenectomy for~     pancreatic or related cancers are randomized to dietary counseling and home exercise, either~     with or without individualized resistance training in order to determine if resistance~     improves outcomes.~   "
23741|NCT03256188|"~     This study tested the feasibility of interrupting prolonged sitting with 10, 3-minute~     activity breaks in elementary school classrooms. Three elementary schools in Southeast~     Michigan (20 teachers, 500 students) participated in this study.~   "
23742|NCT03256175|"~     Elective percutaneous coronary intervention (PCI) is often associated with myocardial~     necrosis evidenced by peri-procedural troponin release. This is a surrogate for subsequent~     cardiovascular events. There is no study on the effect of peri-PCI oxygenation in in~     myocardial protection and cardiopulmonary fitness outcome. Patients with higher baseline~     cardiopulmonary fitness will have lower mortality.~      This study is to assess the utility of oxygen to reduce ischaemia in patients with~     significant stable coronary artery disease scheduled for elective PCI. The secondary~     objective is to evaluate further effect of peri- PCI oxygenation on cardiovascular fitness~     and autonomic response.~   "
23743|NCT03256162|"~     Randomised, controlled, parallel-group, pilot clinical trial of ketamine vs. midazolam as an~     adjunctive therapy for depression. The main purpose of the pilot study is to assess trial~     processes to help inform a future definitive trial.~   "
23744|NCT03256149|"~     Few existing data currently indicates that anti-inflammatory drugs could help diminish the~     local cervical inflammation tough to cause the dysphagia, hoarseness and dyspnea after an~     anterior surgical approach to the spine. This study aims to evaluate the effect of high dose~     of steroids on dysphagia after an anterior cervical spine procedure. Patients subjected to a~     cervical spine surgery through an anterior approach will be randomized to a treatment group~     receiving 3 doses of IV dexamethasone (decadron) and a placebo group receiving saline.~     Outcome will be measured with dysphagia scales, modified barium swallow and~     rhino-pharyngo-laryngoscopy, all done pre and post-operatively. Secondary outcomes involve~     neurological condition, pain and fusion rate.~   "
23745|NCT03256136|"~     This research study is studying a drug intervention as a possible treatment for lung cancer.~      The drugs involved in this study are:~        -  Nivolumab~        -  Carboplatin~        -  Pemetrexed~        -  Ipilimumab~   "
23746|NCT03256123|"~     Based on recent nutrition survey (SEANUTS Malaysia) on a total of 3542 Malaysian Children~     aged between 6 months to 12 years old, 4.4% of the children had vitamin A deficiency. Rural~     areas recorded a higher prevalence of vitamin A deficiency (6.4%) compared with urban areas~     (3.8%). Besides, prevalence of iron deficiency due to low ferritin concentrations is 4.4% and~     anaemia based on low haemoglobin concentrations is 6.6%. It is proposed that a red palm oil~     intervention programme to be conducted in alliance with RMT in Malaysia to enhance the~     Vitamin A status of school children in underprivileged community in Malaysia.~   "
23747|NCT03256110|"~     This mixed-methods study is culturally tailoring and evaluating a communication intervention~     to increase the frequency and quality of advance care planning with diverse American Indian~     and Alaska Native adults with serious, life-limiting illness in primary care at two sites.~   "
23752|NCT03256045|"~     This phase II trial studies how well panobinostat, carfilzomib and dexamethasone work in~     treating patients with multiple myeloma that has come back or does not respond to treatment.~     Panobinostat may stop the growth of cancer cells by blocking some of the enzymes needed for~     cell growth. Drugs used in chemotherapy, such as carfilzomib and dexamethasone, work in~     different ways to stop the growth of cancer cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Using multiple myeloma cells from~     patients' blood samples, the researchers will do laboratory tests to look at how well each of~     the drugs, alone and in different combinations, kill multiple myeloma cells. If the~     laboratory tests work well, they may be used in the future to help plan treatment for future~     patients.~   "
23753|NCT03256032|"~     Patient's sublingual temperature was measured postoperatively on entry to the recovery room.~   "
23754|NCT03256019|"~     This is a clinical study based on the analysis of video-clip data of cardiopulmonary~     resuscitation (CPR) and clinical data for out of hospital cardiac arrest patients between~     2011 and 2015. Aim of study is to compare the endotracheal intubation performance and CPR~     outcomes between videolaryngoscopy (VL) and direct laryngoscopy (DL) users.~   "
23755|NCT03256006|"~     To study per and post effort variations of inflammatory biological markers during a 100 miles~   "
23756|NCT03255993|"~     This study was a single center, parallel, randomized, double blind, placebo-controlled phase~     Ib clinical trial to to evaluate the safety and tolerability and pharmacokinetics of SPH3127~     tablet in healthy subjects by increasing multiple dosing~   "
23757|NCT03255980|"~     To evaluate the performance of Xonrid® in the prevention and treatment of G2 radiation~     dermatitis in breast and head & neck cancer patients.~   "
23758|NCT03255967|"~     Alzheimer's Disease and Related Disorders (dementia) poses a significant challenge to our~     public health. While many persons with dementia are cared for by friends and family in the~     community with the assistance of home healthcare, most home healthcare clinicians and~     agencies are ill prepared to care for this population and therefore have difficulty assisting~     patients and caregivers in maintaining quality of life leading to adverse patient outcomes,~     increased caregiver stress and burnout, and healthcare utilization. This study will therefore~     utilize a cluster randomized controlled design at 3 study sites to examine the ability of a~     multi-component evidence-based practice primary palliative care quality improvement program~     for home healthcare registered nurses, occupational therapists and physical therapists to~     improve the quality of life and reduce healthcare utilization for persons with dementia and~     their informal caregiver.~   "
23759|NCT03255954|"~     Interpersonal Counseling (IPC) is brief, structured modification of Interpersonal~     Psychotherapy (IPT). IPC was developed as a brief triage manual to treat depression in~     primary care, family practice and non-mental health programs, and work and educational~     settings. College and university students are at the age where first episodes of depression,~     bipolar disorder, or psychosis may occur. IPC is relevant for this population as many~     university students' distress are related to profound life changes, role transitions,~     loneliness and social/cultural isolation, which are focuses of treatment in IPC. While there~     is considerable evidence for the efficacy of IPT and IPC, this adaptation for university~     students has not yet been studied. The investigators propose to administer IPC to across~     several college campuses, and to recruit 20 participants at each counseling center.~     Participants will receive 3-6 one-hour therapy sessions, and will complete self-report~     measures of depression, psychosocial functioning, college adjustment, and treatment~     satisfaction. IPC has the potential to reduce depressive symptoms and prevent presenting~     symptoms from worsening. For these reasons, developing and testing a brief, yet comprehensive~     psychosocial intervention for distressed college students has tremendous importance.~   "
23760|NCT03255941|"~     This is a randomized controlled trial comparing lay Lady Health Workers with Lady Health~     Visitors on quantitative measures of safety and effectiveness of Depo Provera and Sayana~     Press provision in a clinic setting. This comparative trial will test the non-inferiority~     hypothesis that Lady Health Workers are just as competent as clinically-trained Lady Health~     Visitors in screening and counseling first-time injectable users. These first time users will~     also be randomly assigned to receive intramuscular or subcutaneous injections of DMPA.~   "
23761|NCT03255928|"~     Consenting patients with end-stage heart failure that are implanted with/candidates for~     implant of a short-term/durable mechanical circulatory support device (e.g.: percutaneous~     microaxial pumps (Impella), extracorporeal membrane oxygenator (ECMO), Ventricular Assist~     Device (VAD) will be enrolled in the study.~      Aim of the study is to evaluate the patients' haemostatic and coagulation profile, how it~     interacts with the support device as well as the effect of antithrombotic drugs. From these~     data, it will be possible to derive the mechanisms triggering post-implant~     thromboembolic/hemorrhagic complications and to identify potential therapeutic targets.~   "
23762|NCT03255915|"~     Participants will have a 28-day pre-ring baseline assessment period (Stage 1) followed by~     randomization to order with 5 participants per study arm. All participants will sequentially~     receive both study products for 28-days with at least a 2-week washout period between~     products. Arm 1 will receive the TDF-FTC pod-IVR for Stage 2 followed by the placebo pod-IVR~     during Stage 3. Arm 2 will receive the placebo pod-IVR for Stage 2 followed by the TDF-FTC~     pod-IVR during Stage 3. During Stages 2 & 3 participants will also complete brief phone~     surveys (<3 min), computer-assisted self-interviews (CASIs), and in-depth interviews (IDIs)~     regarding perceptibility and acceptability. If willing, participants' male sexual partners~     will be invited to complete IDIs as well.~   "
23763|NCT03255902|"~     The purpose of the proposed study, Family Routines - Healthy Families, is to examine the~     feasibility and acceptability of a parenting/family routine intervention program for parents~     of young children, ages 2-5, with type 1 diabetes.~   "
23764|NCT03255889|"~     The primary aim of the study is to test safety and tolerance of oral intake of GT oil in the~     form of a non-diary based emulsion (10g of GT per emulsion) in healthy men. This will be a~     single center study, and the recruitment is expected to happen over a 1-2- month's period.~   "
23829|NCT03255044|"~     There is a controversy whether statins are beneficial in patients with heart failure or not.~     Trials in which lipophilic statins have been used revealed positive results, unlike major~     studies where hydrophilic statins were administered. This trial is designed to compare the~     effects of lipophilic versus hydrophilic statin use in patients with heart failure.~   "
23765|NCT03255876|"~     Results from a large number of studies in humans have shown that diets rich in foods that~     give lower glucose response bring lower risk of type 2 diabetes. Polyphenols, naturally found~     in fruits, vegetables and grains, have shown the potential to attenuate post-prandial blood~     glucose spikes following a carbohydrate-rich meal, through partial inhibition of the main~     enzymes of carbohydrate digestion and reduction in glucose and fructose transport from the~     gut after digestion and by enhancing the insulin action after glucose reaches the~     bloodstream.~      This study is designed to determine whether polyphenols, as normally and naturally present in~     food extracts and beverages, added to a carbohydrate-rich meal, can lower blood glucose~     levels after its consumption, and hence lower its glycaemic index, and if this effect is~     mediated through effects on insulin and other hormones. The study is designed as an acute,~     double-blind, randomised, placebo-controlled crossover trial in 24 healthy subjects with~     normal glycaemic response to white bread. Participants will be asked to consume either white~     bread with pomegranate juice enriched with extracts from grape seeds and apple peels or white~     bread with placebo drink. The effects on plasma glucose levels, levels of hormones and other~     biomarkers involved in postprandial response will be determined over 3 hours after the~     consumption.~   "
23766|NCT03255863|"~     Therapeutic Patient Education (TPE) refers to programs that help patients to manage life with~     a chronic disease in the best possible way. In spite of the effectiveness of Therapeutic~     Patient Education, few patients uptake TPE when it is proposed to them. Therefore, our main~     aim was to identify patients' beliefs that will predict patients' uptake of TPE. According to~     the Health Belief Model, patient will participate in TPE if they perceive their disease as a~     serious threat (with possible serious complications), but which can be controlled however,~     and that TPE is efficient and represents little burden.~      Secondary aims are as follows:~        1. To test whether the way TPE is presented to patients impact patients' decision to uptake~          TPE. The way TPE is presented comprises the time between diagnosis and the proposal of~          TPE, whether patient is a remission or crisis period in the disease, the time between~          the proposal and the next TPE session, and what is said by healthcare professionals to~          present TPE.~        2. To test whether healthcare professionals' empathy impact patients' decision to~          participate in TPE~        3. To test whether patients' intention to participate in TPE will predict their actual~          participation.~      The ultimate goal of the study is to identify patients whose beliefs will not favor~     participation in TPE in order to accompany those patients more carefully. Best practices will~     be proposed according the results.~   "
23767|NCT03255850|"~     This study aims to examine the psychological well-being and QoL of Hong Kong Chinese~     adolescents with CHD by~        -  comparing the self-esteem level, depressive symptoms, and quality of life of adolescents~          suffering from CHD with healthy norms and cancer survivors.~        -  identifying possible factors affecting the quality of life of adolescents suffering from~          CHD.~   "
23768|NCT03255837|"~     This study will involve an experiment in individuals with Autism Spectrum Disorder (ASD)~     comparing their performance on a working memory task before, during and after non-invasive~     brain stimulation (tDCS) compared to a control group in a 3x3 factorial design. How the~     stimulation affects performance on the task will be assessed, along with the impact of the~     intervention on the individuals.~   "
23769|NCT03255824|"~     Hypothesis: A combination of midazolam with dexmedetomidine for sedation during third molar~     surgery will provide 1) superior patient satisfaction, 2) superior operator satisfaction and~     3) no significant hemodynamic or respiratory changes when compared to a sedation combination~     of midazolam, fentanyl and propofol for sedation during third molar surgery.~   "
23770|NCT03255811|"~     At present, apatinib was approved for the treatment of advanced gastric cancer after~     second-line or gastroesophageal junction adenocarcinoma, is in the second one, experience of~     medication, clinical data, no chemotherapy so now intends to carry out 40 cases of small~     sample exploratory research, in the conventional chemotherapy after the onset, with APA for~     Nigeria maintenance treatment, with a preliminary understanding of apatinib in first-line~     advanced gastric cancer to maintain the efficacy and safety of the treatment, and explore the~     feasibility of anti generate small molecule targeted therapy in advanced gastric cancer~     vascular pattern.~   "
23771|NCT03255798|"~     Prospective Evaluation of Open-Angle Glaucoma Subjects treated with two second generation~     iStents and one iStent Supra~   "
23772|NCT03255785|"~     Open Angle Glaucoma Subjects with Cataract treated with Cataract Surgery plus one trabecular~     micro-bypass stent and one suprachoroidal stent~   "
23773|NCT03255772|"~     Genetesis is a cardiac diagnostics company which presents a novel magnetocardiogram (MCG)~     analysis system called CardioFlux. This investigation presents a new, noninvasive diagnostic~     option to use MCG for rapid diagnosis of acute coronary syndrome. Data from the Cardioflux~     system will be compared with stress testing methods as well as the results of cardiac~     catheterization to identify patients with myocardial ischemia.~      This is a prospective observational single-blinded convenience pilot study of 100 patients~     placed in the Clinical Decision Unit (CDU) for evaluation of chest pain at St. John Hospital~     and Medical Center (Detroit, MI).~      Patients enrolled in the study will also have a 30 and 180 day follow up for analysis of~     adverse cardiac events.~   "
23774|NCT03255759|"~     A number of rapid panel-based molecular assays for direct organism identification and~     resistance characterization in positive blood culture bottles are now commercially available.~     They have been shown to improve accuracy and decrease the time-to-result, allowing targeted~     treatment in hospitalized patients with bacteraemia, in high-income countries (HICs).~     However, these molecular assays are add-on tests performed in addition to conventional~     testing, increasing the complexity of diagnostic algorithms and costs of patient care.~     Conventional organism identification includes performing a Gram stain, biochemical~     identification and phenotypic drug susceptibility testing. The FilmArray Blood Culture~     Identification (BioFire, USA) is an example of a rapid panel-based molecular assay that~     combines nesting and multiplexing of PCR (nested multiplex PCR) to detect multiple pathogens~     simultaneously. There are limited data on how such tests impact patient management, health~     care costs and how they can better be incorporated into diagnostic algorithms.~      The aim of this study is to assess the added value and acceptability of a multiplexed~     molecular diagnostic assay in the identification of pathogens in patients presenting with~     bacteremia at hospitals in LMICs, and to assess health care providers' satisfaction with the~     assay.~   "
23775|NCT03255746|"~     Hypertension is the major risk factor for cardiovascular and cerebrovascular diseases~     worldwide. The escalating prevalence of inadequate sleep now parallels that of hypertension.~     Observational and experimental evidence favoring a causal relation between insufficient sleep~     and hypertension are particularly compelling - sleeping 6 hours or less per night is~     associated with a 20-32% higher probability of incident hypertension. Since sleep curtailment~     is largely voluntary, sleep deficiency may be corrected and the detrimental health~     consequences potentially reversed.~      In this study the investigators aim to investigate the effects of 8 weeks of sleep~     enhancement/extension vs health education in prehypertensive and stage 1 hypertensive~     subjects who report habitual short sleep (=6.5 hours/night).~   "
23776|NCT03255733|"~     This study evaluates the effectiveness, safety and patient tolerance for the use of Intense~     Therapeutic Ultrasound (ITU) for chronic, subcutaneous lateral Epicondylitis musculoskeletal~     tissue pain reduction began in July 2015 and was completed in March 2017. The More~     Foundation/The Core Institute: Single-blinded pivotal study for the treatment of chronic~     lateral epicondylitis. A total 29 patients received 2 treatments, 4 weeks apart on~     subcutaneous musculoskeletal tissues along with Standard of Care treatments as prescribed by~     the Principal Investigator. Patients were followed for up to 6 months after the first~     treatment receiving a physical exam at each follow-up visit (4, 8 and 12 weeks) and provided~     feedback via Patient/Subject Reported Outcome Measure surveys specific to the treated anatomy~     at each visit and via phone follow-up at 26 weeks after the first treatment.~   "
23777|NCT03255720|"~     Diffusion Tensor imaging of white matter degeneration in Alzheimer disease~   "
23778|NCT03255707|"~     Amblyopia is a unilateral or, infrequently, a bilateral reduction of best corrected visual~     acuity which cannot be attributed to coexisting eye or visual pathway disease. Amblyopia can~     be due to eye-crossing occurring in early childhood or due to error of refraction whether a~     high difference between the two eyes or very high bilateral refractive errors.Another cause~     could be visual deprivation like the presence of congenital cataract.~      The prevalence of amblyopia worldwide is approximately 1%-5% .In Egypt, a study that was held~     in Upper Egypt, found that the prevalence of amblyopia was 1.49%, which is higher in rural~     areas than in urban areas.~      Several modalities of treatment for amblyopia are available, yet occlusion treatment is the~     gold standard involving covering the good eye with a patch for a prescribed period of time~     ranging from 10 minutes daily to all waking hours. However, its effectiveness decreases in~     older children and adults.~      Disadvantages include prolonged treatment leading to poor compliance, patching related~     distress, relationship strain and stigma. In extreme cases, non-compliance with patching~     results in a costly hospital admission to supervise the patching treatment. In addition,~     wearing a patch eliminates any advantage of binocularity. Not to mention that not all~     patients respond to patching and of those who do, many have residual amblyopia after~     treatment is stopped regardless of compliance. More importantly, binocular vision is not~     automatically restored once the vision in the amblyopic eye has been improved. In fact, once~     the patch is removed after therapy, the amblyopic eye could be suppressed by the better~     seeing eye and can lose some of the gains achieved as a result of therapy.~      Another modality of treatment is atropine eye drops and optical penalisation which are~     usually secondary treatments to failed patching but carrying the same disadvantages as the~     ordinary patching.~      Advances in amblyopia treatment include dichoptic training, perceptual learning, and video~     gaming. These depend on the fact that the adult brain has been shown to be much more plastic~     than it was once believed to be and hence have the advantage of expanding the age of response~     in adults.~      Perceptual learning approaches have the advantage of being a dichoptic (binocular treatment~     using both eyes) approach which is independent of age and type of amblyopia.~      A step further to conventional treatment is the use of a home-based approach allowing remote~     internet monitoring of treatment between office visits and hence better compliance. In~     addition a video game version of the treatment is developed to make it more enjoyable for~     improving compliance.~      Our goal is to compare the outcome between the gold standard occlusion therapy and one of the~     dichoptic treatments.~   "
23779|NCT03255694|"~     After the first stage (52 weeks) of Phase II clinical trial, Pegylated recombinant human~     growth hormone (PEG-rhGH) injection of appropriate dose in compliance with ISS clinical~     treatment strategy is used to treat children with ISS (Idiopathic Short Stature). The~     long-term efficacy and safety of the investigational product are evaluated, which can provide~     more scientific and reliable medication guidance information for clinical diagnosis and~     treatment.~   "
23780|NCT03255681|"~     The purpose of the study is to determine the efficacy of platelet-rich plasma (PRP) as a~     cosmetic facial injectable filler to treat tear troughs deformities secondary to volume loss~     and skin laxity in the infra-orbital region. Patients will receive injections of PRP on the~     left side, and PRP with A VectraH1 3D camera will be used to quantify the volume of the~     infra-orbital region before treatment, at 1, 3, 6 and 12 months post treatment. The objective~     is to quantify the amount of volume gained in the region as well as to assess duration of~     volumization after PRP treatment and also if volumization results are permanent.~   "
23781|NCT03255668|"~     Subjects who are recruited in this study are LLA patient, who are treated for routine control~     to Cipto Mangunkusumo Hospital, who meet the inclusion criteria and do not meet the exclusion~     criteria.~   "
23782|NCT03255655|"~     Double-blinded feasibility study for the treatment of pain related to chronic plantar~     fasciitis. A total 37 patients (27 treated and 12 control/sham treated) received 2~     treatments, 2 weeks apart on subcutaneous plantar fascia musculoskeletal tissue along with~     Standard of Care treatments as prescribed by the Principal Investigator. Patients were~     followed for up to 6 months after the first treatment receiving a physical exam at each~     follow-up visit (4, 8 and 12 weeks) and provided feedback via Patient/Subject Reported~     Outcome Measure surveys specific to the treated anatomy at each visit and via phone follow-up~     at 26 weeks after the first treatment.~   "
23783|NCT03255642|"~     This study aimed to evaluate influence of melatonin or clonazepam treatment on symptom and~     polysomnographic parameters in patients with idiopathic REM sleep behavior disorder.~   "
23784|NCT03255629|"~     To assess the efficacy of a closed loop glucagon system to prevent and treat hypoglycemia~     occurring in patients with Post-Bariatric Hypoglycemia (PBH) in response to meals and~     exercise.~   "
23785|NCT03255616|"~     The aim is to disentangle the supraspinal sensorimotor representation and its potential~     cortical reorganization of different thoraco-lumbar motion segments by using a novel~     computer-controlled, MR compatible pneumatic spinal indentation device (pneuSPID).~   "
23798|NCT03255447|"~     Autoimmune Membranous Nephropathy is now understood to be a condition caused by the immune~     system although the exact mechanism is not completely known. This study aims to remove the~     offending part of the immune system using immunoadsorption to not only treat the disease but~     also use the opportunity to better understand the mechanism of disease. This will allow more~     targeted treatment in the future with less complications and side effects.~   "
23799|NCT03255434|"~     Cytotoxic chemotherapy is usually scaled to the body surface area (BSA), and is currently not~     adjusted to the body proportions of lean and fat (i.e. body composition) of individual~     patients. Patients with low muscle mass behave like patients overdosed with chemotherapy~     resulted in dose-limiting toxicities (e.g. dose reductions, treatment delays or permanent~     treatment discontinuation), independently of the patient's weight.~   "
23786|NCT03255603|"~     The rates of chronic diseases like obesity, diabetes, and heart disease are rising across the~     world. This is especially true in industrialized countries like Canada and the USA. Even~     though there are many possible causes for these increases. One prominent cause is our refined~     diet, which greatly lacks dietary fiber. This 'fiber gap' between the amount of fiber~     actually eaten and the amount that should be eaten is likely promoting these diseases.~      It is known that a high fiber diet can benefit health and the health of the gut bacteria. It~     is also know that these gut microbes can help cause and prevent diseases. When fiber is~     eaten, it gets broken down not by us, but by our gut microbes. During this process~     by-products called short-chain fatty acids (SCFA) are made. These SCFA have been shown to~     promote health. Therefore, it is thought that fiber changes the gut microbes to produce more~     SCFA, which may improve overall health.~      In order to aid our microbes and improve our health we need to find ways to reduce this~     'fiber gap'. One possibility is to add fiber to our refined diet. To do so we must first~     learn how different fibers perform in our gut. This includes how our gut tolerates increasing~     amounts of fiber, and how our microbes respond. The purpose of this study is to learn how~     different types of resistant starch perform in our gut, including gastrointestinal tolerance.~     By doing so we will determine the ideal dose and type of these fibers to use in future~     studies.~   "
23787|NCT03255590|"~     This study plans to determine whether training with concurrent non-invasive brain stimulation~     can change abnormal flexion synergy in chronic stroke patients.~   "
23788|NCT03255577|"~     This study is being done to help the investigators determine how accurate the sentinel lymph~     node biopsy (SLNB) procedure is in identifying residual cancer cells after neoadjuvant~     chemotherapy in patients presenting with locally advanced breast cancer.~   "
23789|NCT03255564|"~     Infants born with heart problems are at risk of developing gut disease due to reduced blood~     flow to the intestines which can result in poor weight gain, surgery and even death. At~     present, doctors are often unaware of any gut problems until clinical symptoms present (poor~     feed tolerance, blood stained stools or bloated stomach) which is often too late to prevent~     gut damage.~      Earlier diagnosis of gut disease may now be possible; calprotectin is produced when the gut~     is inflamed and can be found in faeces and blood. Calprotectin levels have been shown to be a~     reliable marker in diagnosing gut disease in premature infants. To date, calprotectin levels~     have not been monitored in infants with cardiac defects, who like premature infants are at~     high risk of gut disease but the cause of gut disease is different to that seen in premature~     infants and therefore requires specific monitoring.~      This study will implement a high risk feeding protocol which has been adapted from current~     feeding practices from the United States; the aim being to promote weight gain without~     increasing the risk of gut inflammation. Furthermore, the study will validate whether faecal~     calprotectin is a useful non-invasive marker in identifying gut disease in infants with~     cardiac defects. Currently, infants are diagnosed with necrotising enterocolitis by an~     abdominal X-ray (current 'Gold Standard'); infants who have a positive diagnosis will have~     faecal calprotectin levels cross-checked. From this data, cut-off values will be established~     which will provide data to diagnose necrotising enterocolitis eliminating the need for X-rays~     (radiation).~      Secondly, faecal calprotectin levels will be measured at strategic time points (longitudinal~     data) linked to increased risk of gut damage (following cardiac surgery and feeding) which~     will then be cross-checked against infants that developed NEC to identify whether high risk~     infants had raised calprotectin levels earlier.~   "
23790|NCT03255551|"~     Blood Pressure Lowering Effects of Amosartan Regarding Proviso in Patients with Hypertension~   "
23791|NCT03255538|"~     Despite DFM being a widely-used technique and the empirical grounding regarding the~     importance of the pressure applied, there is no study characterizing the pressure applied~     during DFM, remaining it a discretion of the physiotherapist. Additionally, it is not known~     how the amount of pressure applied may influence pain mechanisms or function in the~     symptomatic patellar tendon. Having this, our objective is to characterize the pressure~     applied during deep friction massage and evaluate the immediate effects of different~     pressures applied during deep friction massage in the time until analgesia as well as in~     function, in patellar tendinopathy.~   "
23792|NCT03255525|"~     Despite DFM being a widely-used technique and the empirical grounding regarding the~     importance of the pressure applied, there is no study characterizing the pressure applied~     during DFM, remaining it a discretion of the physiotherapist. Additionally, it is not known~     how the amount of pressure applied may influence pain mechanisms and, consequently how it~     affects the time needed promote an analgesic response.~      Having this, our general objective is to establish a dose-response relationship between the~     pressure applied during DFM and time of onset of analgesia, in the asymptomatic patellar~     tendon.~   "
23793|NCT03255512|"~     This study is intended to investigate the pharmacodynamic drug-drug interaction as well as~     the safety and tolerability of isosorbite mononitrate and vericiguat in patients with stable~     coronary artery disease.~   "
23794|NCT03255499|"~     This study aims to test the efficacy of the MovinCog Intervention to enhance cognitive~     abilities in children 7-15 yrs. The intervention consists of two parts: a physical exercise~     regimen, based on high-intensity training, and a cognitive training component. The design~     will contrast the intervention with an active control group, matched for expectancy effects.~   "
23795|NCT03255486|"~     Biomarkers of resistance to neoadjuvant chemotherapy in locally advanced breast cancer~   "
23796|NCT03255473|"~     Compare hearing outcomes between treatment with dexamethasone versus prednisone in~     participants who have been diagnosed with unilateral SSNHL (sudden sensorineural hearing~     loss).~   "
23797|NCT03255460|"~     Multiple sclerosis (MS) is a chronic, progressive and unpredictable disease of the central~     nervous system. In MS, various loss of strength, balance and gait disturbances arise in the~     central nervous system due to sensory and/or motor neuron degeneration. These disorders lead~     to limitations in individual activities and participation.~      Fatigue is as reported one of the most common first three symptoms among patients with MS and~     affects up to 80% of the patients. Fatigue is defined as the lack of physical and/or mental~     energy. Sometimes fatigue can reduce the quality of life by leaving other disorders behind.~     The most important effect of fatigue is that individuals reduce their physical activity~     levels. This can lead to the inactivity-related secondary problems being added to the~     findings of the disease. So the physical capacities of individuals may gradually decrease.~      In the literature, there are many studies showing that the level of physical activity of~     individuals with MS is lower than in healthy individuals. When the investigators analyze the~     studies that investigate the relation between fatigue and physical activity levels, it is~     seen that there is the single study about this subject in the literature.~      As a result, additional studies are needed to investigate the level of physical activity and~     the factors affecting it in individuals with MS. Therefore, the investigators planned this~     study to investigate the relationship between fatigue and physical activity levels in~     patients with MS.~   "
23802|NCT03255395|"~     AIM: To provide initial information on the efficacy (pain reduction) and safety of focused~     ultrasound surgery for the ablation of stump neuromas in amputees with chronic neuropathic~     pain.~      PARTICIPANTS: The study will include 10 amputees (men/women age >18 years old) with chronic~     (>3 months) phantom/residual limb pain (NPS ≥ 4).~      DESIGN: Patients potentially qualifying for the study will be offered an Informed Consent to~     sign prior to further evaluation. Those who accept will sign the informed consent, complete~     study questionnaires and be evaluated in terms of inclusion/exclusion criteria. Specifically,~     a complete medical history will be obtained to determine the patient's general health status,~     current symptoms, frequency and dosage of their current analgesic intake etc. Baseline pain~     scores will be established. If not performed within six months prior to the evaluation, a~     contrast MRI of the stump will be performed. Patients not meeting the study criteria will be~     exited from the study as screen failures and not be included in analyses. All qualifying~     patients will complete a baseline MRI exam on treatment day. Any patient not meeting study~     criteria at Imaging will be exited as screen failures.~      After completion of the MRI exam, qualifying patients will proceed to the ExAblate treatment.~     These patients will then be followed for 6-months post-ExAblate treatment; the patients will~     complete study follow-up questionnaires at 1, 3 days, 1 and 2 weeks, and 1, 3 and 6 months~     after treatments. Follow-up visits will take place 1 week and 1, 3 and 6 months after~     treatment to assess their pain status, their quality of life and safety. Data regarding~     dosage and frequency of analgesic intake for the management of post amputation NP will be~     collected. Relevant cost data will be collected in order to enable an assessment of the total~     cost of the procedure.~   "
23803|NCT03255382|"~     The purpose of this study is to compare the efficacy and safety of subcutaneous (SC)~     risankizumab and oral FUMADERM provided as study medication in subjects with moderate to~     severe plaque psoriasis who are naïve to and candidates for systemic therapy.~   "
23804|NCT03255369|"~     The recent increase in the number of cases of congenital microcephaly observed in Brazil is a~     reason of great concern. This increase occurred a few months after Zika virus (ZIKV) was~     introduced in the country, which was associated with reports of pregnant women presenting~     fever and rash illness during pregnancy. Thus, the hypothesis of a relationship between ZIKV~     infection and microcephaly became plausible. However, studies on the pathophysiology of~     maternal ZIKV infection, its consequences for the fetus, and the development of severe~     encephalopathy are still needed. Knowledge about the natural history of vertical transmission~     and its association with changes in fetal development in early life is still scarce. Studies~     on factors which determine the severity and clinical evolution, such as inflammatory response~     mechanisms, viral evolution, and development of serological tests to identify ZIKV infection,~     are still needed. The Aedes aegypti is responsible for the transmission of various types of~     viruses of interest to human health. Currently, it is primarily responsible for the~     transmission of the dengue, chikungunya, and ZIKV in epidemic proportions. In addition, it is~     not yet known whether there is an interaction between these viruses and whether the~     interaction can determine the severity of the disease. The aim of this study is to evaluate~     the natural history of ZIKV disease in two cohorts( pregnant women and children) starting~     with pregnant women or newborns or evennursing mothers, identifying risk biomarkers, mapping~     the anti-viral inflammatory response, evaluating the molecular evolution of the virus,which~     areimportant to determine the mechanisms of vertical viral infection and verify children~     neurodevelopment from birth to the end of 3rd year of life.~   "
23805|NCT03255356|"~     The purpose of this study is to evaluate prospectively ventilatory practices in the~     perioperative cardiac surgery period.~   "
23806|NCT03255343|"~     Objective (s) : To Evaluate the efficacy and safety of Treatment of non-responding to~     conventional therapy inoperable liver cancers by in situ introduction of ImDendrim.~      Trial Design:~      An, open-labeled and unicenter study in women or men with primary hepatocellular cancer or~     metastatic liver without standard therapeutic options for treatment including chemotherapy or~     surgery.~   "
23807|NCT03255330|"~     Study of the effect of gabapentin used as a preemptive to the emergence and development~     chronic neuropathic pain in patients after spinal cord trauma~   "
23808|NCT03255317|"~     The aim of this study is to evaluate the efficacy of engagement strategies for increasing~     daily data collection adherence among substance-using youth between the ages of 14 and 24.~     The primary hypotheses of this study are that: (1) receiving a reinforcer after completing~     daily data collection activities will predict next-day completion of targeted data collection~     activities; and (2) receiving a notification prior to 6pm (when data collection activities~     open) will predict same-day completion of data collection activities.~   "
23809|NCT03255304|"~     The current proposal aims to investigate implicit and explicit priming paradigms for changing~     cue-dependent and goal-directed nutritional behavior.~   "
23810|NCT03255291|"~     Epidemiology seeks to improve public health by identifying risk factors for cancer and other~     diseases and conveying that information to relevant audiences (e.g., physicians, the public).~     The audience is presumed to understand and use that information to make appropriate decisions~     about lifestyle behaviors and medical treatments. Yet, even though a single risk factor can~     affect the risk of multiple health outcomes, this information is seldom communicated to~     people in a way that optimizes their understanding of the importance of engaging in a single~     healthy behavior. Providing individuals with the ability to understand how a single behavior~     (obtaining sufficient physical activity) could affect their risk of developing multiple~     diseases could foster a more coherent and meaningful picture of the behavior's importance in~     reducing health risks, increase motivation and intentions to engage in the behavior, and over~     time improve public health.~      The proposed study translates epidemiological data about five diseases that cause significant~     morbidity and mortality (i.e., colon cancer, breast cancer (women), heart disease, diabetes,~     and stroke) into a visual display that conveys individualized risk estimates in a~     comprehensible, meaningful, and useful way to diverse lay audiences.~   "
23811|NCT03255278|"~     The study is aimed to evaluate the safety and immunogenicity of the medicinal product~     GamTBvac - a recombinant subunit vaccine against the tuberculosis. The study is designed as~     a comparative placebo-controlled study with a two-fold increase of an applied dose among~     healthy volunteers aged 18-49 years.~   "
23828|NCT03255057|"~     This study evaluates the safety and efficacy of using the Hemolung RAS to provide low-flow~     extracorporeal carbon dioxide removal (ECCO2R) as an alternative or adjunct to invasive~     mechanical ventilation for patients who require respiratory support due to an acute~     exacerbation of Chronic Obstructive Pulmonary Disease (COPD). It is hypothesized that the~     Hemolung RAS can be safely used to avoid or reduce time on invasive mechanical ventilation~     compared to COPD patients treated with standard-of-care mechanical ventilation alone.~     Eligible patients will be randomized to receive lung support with either the Hemolung RAS~     plus standard-of-care mechanical ventilation, or standard-of-care mechanical ventilation~     alone.~   "
23812|NCT03255265|"~     Organ transplantation has become an effective therapy for patients with end-stage organ~     failure at present. Rejection is still the most common cause of early dysfunction after organ~     transplantation. A large number of experimental and clinical data are suggesting that the~     formation of microchimer can successfully achieve donor-specific immune tolerance after~     transplantation. The formation of microchimerism may be one of the long-term survival~     mechanisms of transplantation, and the detection of microchimerism after transplantation can~     effectively predict the rejection of grafts. Scientists from Stanford University in the~     United States continued to report in 2014 and 2015 that using a new generation of~     high-throughput sequencing technology (NGS) to detect the level of free DNA from donor in~     blood plasma of recipients after cardiac and lung transplantation. The investigators found~     the level of free DNA in donor significantly increased when acute or chronic rejection~     happens, thus it may be used as a reflection of rejection or graft injury markers.~      It has been reported that microchimerization and donor free DNA levels are associated with~     rejection after organ transplantation, but these studies are mostly based on a small number~     of cases and the results of which re qualitative and can not provide a specific~     microchimerization rate due to limited detection techniques. Therefore, in order to clarify~     the role of microchimerism and the level of cell-free DNA in donor in organ transplantation~     tolerance, it is necessary to use a new generation of detection technology for multi-center~     study with large samples.~      Clinical trial was used to evaluate the clinical prediction and diagnostic value of~     microchimerization rate and donor cfDNA for acute rejection after organ transplantation.~      950 cases of organ transplantation, of which 600 cases of renal transplantation, 300 cases of~     liver transplantation and 50 cases of lung transplantation.8 ml peripheral blood was~     collected in 1 tubes with EDTA anticoagulation. The timing of the collection was as follows:~     Patients with routine treatment after transplantation were preformed once every one weeks for~     one months and then every 3 month until the one year. In case of acute rejection, the~     additional blood was collected once on the day of diagnosis, and once after the treatment~     remission. All the samples were detected for microchimerism and cfDNA.~   "
23813|NCT03255252|"~     Perspectives:~        -  To set-up another clinical trial with this specific phenotype as the main stratification~          factor. Therefore a more aggressive or a more specific systemic treatment (with or~          without an immunomodulator) could be proposed to those selected patients in the field of~          personalized medicine.~        -  To evaluate the use of the smear as a surrogate non-invasive technique to biopsy for~          immunomonitoring.~        -  To use the CTC/PD-L1 assay as a liquid biopsy in future clinical trials for~          stratification and monitoring of cancer patients undergoing immune checkpoint~          treatments. This specific subset of CTCs might represent metastatic cells with a high~          potential to escape T cell-mediated lysis and might therefore be the actual targets of~          immunotherapy.~   "
23814|NCT03255239|"~     Randomized clinical trial comparing open preperitoneal mesh, retromuscular mesh and suture~     repair for ventral hernias less than 3 cm diameter~   "
23815|NCT03255226|"~     To determine the efficacy, safety, and dose and regimen of tolvaptan in pediatric CHF~     patients with volume overload~   "
23816|NCT03255213|"~     This study is being done to test the effects of Lingual Muscle Therapy (LMT) in patients with~     Late-Onset Pompe Disease (LOPD) who have tongue weakness. The results of this study will help~     design future research studies about LMT in LOPD.~   "
23817|NCT03255200|"~     To gather data on the long-term safety of ReActiv8 and identify any residual risks by~     reporting all Serious Adverse Device Effects as well as performance and health care~     utilization through two years post-implant.~   "
23818|NCT03255187|"~     This study aims to evaluate whether dietary supplementation with fish oil can protect against~     the cardiopulmonary alterations linked to air pollution~   "
23819|NCT03255174|"~     The objective of this study is to evaluate the safety and hemostatic effectiveness of~     EVARREST as an adjunct to controlling mild to moderate soft hepatic parenchyma or soft tissue~     bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac)~     surgery in pediatric population.~   "
23820|NCT03255161|"~     The purpose of this study is to test the effectiveness of a community health worker~     intervention to expand access to hearing health care among older adults facing health~     disparities.~   "
23821|NCT03255148|"~     In this study, the investigators will explore the influence of oxytocin administration on~     several neurophysiological responses (EEG, skin conductance and heart rate) during rest.~   "
23822|NCT03255135|"~     Prostate cancer (PCa) is the most prevalent non cutaneous cancer in occidental countries. In~     Brazil incidence was about sixty thousand new cases in 2016 and occupied second place as all~     cancer mortality, just behind lung cancer. Literature shows than younger patients tend to~     have more aggressive tumors rising cancer specific mortality scores. Main risk factors are~     age, life style (sedentary, high meat and fat intake) and family history (gene inheritance).~      Besides vast advances in precocious tumors detection, challenges remain in the definition of~     the biological status of the tumor, which is highly variable and full of prognostic~     implications. PCa heterogeneity is demonstrated by the uncertain natural history, varying~     from indolent lesion to aggressive metastatic and fast progression cancer resistant to~     conventional therapies. In an actual treatment scenario, prognostic identification is the~     cornerstone of daily practice treatment considering the natural history variability cited~     before and the discrepancy of long term slow growth (studies estimate eight to sixteen years~     of tumor growth to achieve metastatic disease) to high grade aggressive cancer.~      Considering all this background and taking in account the indolent evolution of low risk PCa~     new therapies emerge with promising outcomes. High-Intensity Focused Ultrasound (HIFU) have~     to be highlighted due to easy operation, good oncologic results and low complication profile.~     The method is based on real-time imaging guided high intensity ultrasound (US) causing~     overheat and cavitation in the focused tissue. Applied since 90's, mainly in German and~     French groups, initially programmed to treat hole gland preserving only urinary sphincter and~     bladder neck, showed recently some data on 1700 patients, 5 years biochemical recurrence free~     survival of 80% and best results including morbidity profile in low risk, low prostate volume~     and in the group with previous trans urethral prostate resection (TURP). This results are~     very similar to other radical treatment options with median follow up of 8 years, cancer~     specific survival 98% and metastasis free survival of 95% If local recurrence was identified~     another HIFU ablation or even radical treatment achieved good results in local control with~     acceptable morbidity profile.~      Focal treatment is a new entity in PCa therapy. One randomized trial compared focal treatment~     to active surveillance in 513 mans with PCa diagnosis. With a 24 month follow-up~     progression-free ratios (28% x 58%) and positive control prostate biopsy ratios (14% x 49%)~     were fairly superior in treatment group. This exiting novel data turns urological oncology~     paths to the new era of minimally harmful therapy with targeted focused procedure. At our~     knowledge there is no high evidence clinical trial comparing HIFU to active surveillance.~      The objective of this study is to evaluate prospectively the initial experience with 50~     patients submitted to HIFU therapy for low risk prostate cancer in Brazilian single center~     considering the following aspects:~      One year of treatment prostate biopsy positiveness; Biochemical recurrence free survival~     using Phoenix and Stuttgart criteria in one year; Sexual function using IIEF-5 questionnaire~     and the usage of 5-phosphodiesterase inhibitors (5-PDI); Urinary symptoms using EPIC and IPSS~     questionnaires and free urinary flow; Quality of life based on SF-36 questionnaire~     evaluation; Post procedure morbidity using Clavien-Dindo classification.~   "
23823|NCT03255122|"~     The goal of the study is to evaluate the efficacy of an Internet-delivered format of an~     evidence-based CBT treatment for early social anxiety disorder (Coaching Approach behavior~     and Leading by Modeling, or the CALM Program) in which therapists and families meet in~     real-time via videoconferencing and parent-child interactions are broadcast from the family's~     home via a webcam while therapists provide bug-in-the-ear coaching from a remote site. In a~     randomized controlled trial (RCT), the proposed work will evaluate 40 youth with social~     anxiety disorder (ages 3-8); 20 will receive the CALM Program over the Internet (I-CALM) and~     20 will be assigned to a waitlist control and will complete a course of I-CALM after the~     waitlist period. Outcomes will be assessed via structured diagnostic interviews and~     parent-report questionnaires.~   "
23824|NCT03255109|"~     WEAN SAFE (WorldwidE AssessmeNt of Separation of pAtients From ventilatory assistancE) is a~     multi-centre, prospective, observational, 4-week inception cohort study being carried out by~     the Acute Respiratory Failure section of ESICM. Weaning represents a challenge for~     intensivists and patients spend a considerable amount of time in being liberated from~     mechanical ventilation. While guidelines do exist on the classification of weaning, a recent~     study has shown that these may not be applicable to all patients. Moreover, different~     practices exist in regard to weaning procedures. WEAN SAFE will prospectively assess the~     burden of, management and spectrum of approaches to weaning from ventilation, in patients~     that require invasive mechanical ventilation for any reason, for a time period of at least 24~     hours.~   "
23825|NCT03255096|"~     The purpose of this study is to evaluate the safety, tolerability and clinical activity of~     RO6870810 in combination with venetoclax and when co-administered with rituximab in~     participants with relapse/refractory (R/R) diffuse large B-cell lymphoma (DLBCL).~   "
23826|NCT03255083|"~     This study has two parts: dose escalation and dose expansion.~      The primary objectives are:~        -  For Dose Escalation, to assess the safety and tolerability of DS-1205c when combined~          with osimertinib in the study population and to determine the recommended dose for~          expansion of DS-1205c when combined with osimertinib in the study population~        -  For Dose Expansion, to assess the safety and tolerability of DS-1205c when combined with~          osimertinib in the study population~      In Dose Escalation, after a 7-day run in period (Cycle 0), there will be 21-day cycles (Cycle~     1 onward). In Dose Expansion, there will be 21-day cycles.~      The number of treatment cycles is not fixed in this study. Participants will continue study~     treatment for 36 months unless they decide not to (withdraw consent), their disease gets~     worse [progressive disease (PD)], or side effects become unacceptable (unacceptable~     toxicity).~   "
23830|NCT03255031|"~     Background:~      A ketogenic diet (KD) is high in fat and low in carbohydrates. Research has shown that a KD~     can lessen tremor in animals withdrawing from alcohol. KD can also help people who have~     difficulties with thinking, sleep, and mood. Researchers want to see if KD can lessen~     symptoms of alcohol withdrawal in people with alcohol use disorder.~      Objective:<TAB>~      To test the effects of a ketogenic diet on alcohol withdrawal symptoms.~      Eligibility:~      Adults 18 years or older who are moderate or severe alcohol drinkers and are seeking~     treatment for alcohol use. They must be in the NIAAA inpatient alcohol treatment program.~      Design:~      Participants will be screened under another protocol. They will have a medical and~     psychiatric history, physical exam, and blood and urine tests. Participants will have a~     breath test for alcohol.~      The study will be done in a 3-week stay in the clinic.~      Participants will get either a KD or Standard American diet.~      Participants will have breathalyzer, blood, and urine tests.~      Participants will have magnetic resonance imaging (MRI) scans. The scanner is a cylinder in a~     magnetic field. They will lie on a table that slides in and out of the cylinder. They will do~     tasks on a computer during the scan.~      Participants will have tests of thinking, memory, and attention.~      Participants will have their sleeping and waking measured. They will wear a device like a~     headband held in place with elastic straps. Several electrodes will be placed on the body.~      Participants will have heart tests.~      Participants will wear an activity monitor on the wrist.~      After the clinic stay, participants will be called by phone about 5 times over 3 months.~   "
23831|NCT03255018|"~     Background:~      B-cell lymphoma is a cancer of white blood cells that are found in lymph nodes. Some kinds of~     these cancers, such as gray-zone and extra-nodal, are rare and often aggressive. They are~     usually resistant to current treatments. Researchers want to see if a drug called~     pembrolizumab may treat these types of lymphoma.~      Objective:~      To collect data to see if it may be effective to give pembrolizumab to people with certain~     types of rare, aggressive B-cell lymphomas.~      Eligibility:~      People ages 14 and older who have a B-cell lymphoma, including gray-zone lymphoma or~     extra-nodal lymphoma~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Blood and urine tests~      Scans. They will lie in a machine that takes images.~      A tissue sample from a previous procedure will be tested.~      The study will be done in 21-day cycles. During the study, participants:~      Will repeat the screening tests.~      Will get the study drug as an infusion into a vein over about 30 minutes.~      Will have a cheek swab and/or saliva sample collected.~      May have a bone marrow aspiration. A needle will be put into the hipbone, and a small amount~     of bone marrow will be taken out.~      May have a lumbar puncture. If cerebrospinal fluid is collected, researchers will study it.~      May have an eye exam.~      May provide tissue samples.~      May have tumor samples taken.~      Participants will have a visit about 30 days after the last dose of the study drug. They will~     then have 4 visits in year 1, 2 visits a year in years 2-5, and once each year thereafter.~     They will also be contacted by phone.~   "
23832|NCT03255005|"~     The aim of this trial is to evaluate the efficacy of an endoluminal vertical gastroplasty~     (EVG) using an endoluminal-suturing device. Safety will also be characterized, in particular~     by the incidence of all Adverse Device Effects (ADEs). A secondary endpoint is to compare a~     delayed treatment control group (diet alone; crossover at 6 months) with a treatment group~     (EVG plus diet). Other secondary endpoints include improvements in other obesity measures.~   "
23833|NCT03254992|"~     Individuals with Autism Spectrum Disorder (ASD) are known to have difficulty with~     socio-communicative functioning and restricted or repetitive behaviors or interests, and~     there is considerable evidence that the majority also struggle with associated emotional~     problems. Speech is typically delayed or may regress, comprehension is impaired, if not at~     the word level, then at the level of sentences, nonverbal and verbal language are affected,~     and pretend play is delayed or absent, some children are nonverbal or have sparse,~     impoverished, poorly articulated, and grammatical speech. Objective: To assess in which~     interface has ASD best performance or functionality. Method: Will be evaluated 100~     individuals divided into two groups: 50 individuals with diagnosis of Autistic Spectrum~     Disorder (ASD-group), aged 7 to 15 years old, males and females; and 50 individuals with~     typical development (TD-group) matched by age and sex to the ASD-group. Individuals with~     comorbidities and functional disabilities that would impede the completion of the task were~     excluded.~   "
23834|NCT03254979|"~     RATIONALE The translation into clinical practice of Primary Care (PHC) of effective and~     sustainable interventions to prevent of type-2 diabetes (T2D) remains an unresolved~     challenge. Leadership, active involvement of professionals, facilitation and adaptation to~     the local context and their determinants are known to be key components in the success of~     implementation strategies that seek to optimize clinical practice. However, one of the areas~     in which there is still no evidence is related to the effectiveness of different strategies~     to engage healthcare professionals in such innovation processes. Especially in real-world~     Primary Care clinical contexts characterized by work overload and limited time, with marked~     differentiation of professional status, both at the level of identity and competency.~      OBJECTIVES To assess the effect of PHC providers engagement procedure in the creation and~     execution of a facilitated collaborative modelling process, in the adoption, reach,~     implementation and effectiveness of the recommended clinical practice for the prevention of~     type-2 Diabetes~      METHODOLOGY~      Randomized cluster hybrid trial in which 9 PHC centres from Osakidetza will be allocated to~     two different strategies to engage professionals and create an inter-professional~     collaborative practice directed by a local leader and an external facilitator, to optimize~     the integration of a T2D primary prevention program:~        -  A strategy focused on the sequential activation: started in nursing, which finally~          manages to involve the whole center~        -  A global strategy with the participation of all professionals from the beginning~      All centres and PHC professionals will receive training on current guidelines and scientific~     evidence in primary prevention of T2D and effective interventions to promote healthy~     lifestyles. Headed by a local leader and an external facilitator, centres will conduct a~     collaborative structured process to model and adapt the intervention and its implementation~     to the specific context of professionals and centres, and the determinants of T2D prevention~     practice. One of the groups will perform this strategy globally, promoting the cooperation of~     all health professionals from the beginning. The other will perform it sequentially, centred~     first in nursing, who will lately seek the pragmatic cooperation of physicians and other~     professionals.~      All patients without diabetes aged ≥30 years old who attend at least once in collaborating~     centres at high risk of developing T2DM (FINDRISC> = 14 points and / or intermediate~     hyperglycaemia) will be eligible for program inclusion. The main outcome measures focus on~     observed changes in T2DM prevention clinical practice at centre level after 12 and 24 months,~     as a result of the implementation of one or another engagement strategy. Secondary outcomes~     will compare their clinical effectiveness in changing exposed eligible patients' main~     cardio-metabolic risk factors (Weight, BMI, Cholesterol, Glucose, Triglycerides) and~     lifestyles behaviours (physical activity and diet) after 12 months.~   "
23835|NCT03254966|"~     To evaluate the safety and efficacy of SHR0302 tablets (SHR0302) in subjects with moderate to~     severe active rheumatoid arthritis.~   "
23853|NCT03254732|"~     This is a phase 1b, open label trial of ADI-PEG 20 (36 mg/m2) weekly in combination with~     pembrolizumab (1 and 2 mg/kg or 200 mg) every three weeks. Assessment of safety and~     tolerability of drug combination~   "
23836|NCT03254953|"~     This study is a randomized controlled trial that compares 3 self-monitoring approaches for~     weight loss. GoalTracker is a standalone, technology-based intervention using a commercial~     smartphone app (MyFitnessPal) and email.~      The investigators hypothesize that the group that delays diet tracking and receives~     additional intervention components (weekly personalized feedback, skills training, and action~     plans) will have greater weight loss at the end of the 12-week intervention and at 6-month~     followup, compared to (a) an intervention group that simultaneously tracks weight and diet~     for all 12 weeks and receives the same additional components, and (b) a control group that~     tracks only diet.~   "
23837|NCT03254940|"~     This study evaluates different versions of a text messaging-based app for weight loss. This~     study will place participants to 1 of 32 experimental conditions that reflect different~     texting components and levels. Participants will be randomized to a condition. The~     investigators will recruit 448 adults into a 6-month weight loss program, with an additional~     follow-up 6-months after the intervention ends.~   "
23838|NCT03254927|"~     This is a study to determine the clinical benefit (how well the drug works), safety and~     tolerability of combining CDX-3379 and cetuximab. The study will enroll patients with~     advanced head and neck squamous cell carcinoma who have previously received cetuximab and~     progressed.~   "
23839|NCT03254914|"~     The purpose of this study is to evaluate the effect of home blood pressure monitoring on~     controlling blood pressure and correlation between home blood pressure and clinic blood~     pressure in hypertensive patients receiving two or more concomitant antihypertensive agents~     including fimasartan~   "
23840|NCT03254901|"~     Viral hepatitis is a global health problem affecting hundred millions of people worldwide and~     considered the main cause of liver cirrhosis, hepatocellular carcinoma and liver~     transplantation in developing countries.~   "
23841|NCT03254888|"~     • Bladder cancer is the most common malignancy of the urinary tract. It represents the 7th~     most commonly diagnosed cancer in male population worldwide and drops to the 11th when both~     genders are considered . According to the American cancer society's estimates of bladder~     cancer in 2017, the number of the new cases of bladder cancer is 79,030, and the mortality~     figures reached 16,870 .~   "
23842|NCT03254875|"~     The aim of the study is to evaluate whether a screening-based individually tailored nurse~     navigator intervention compared to standard care significantly reduce psychological and~     physical symptoms among women being treated for breast cancer who had moderate-to-severe~     distress (score ≥ 7 on the distress thermometer).~   "
23843|NCT03254862|"~     The main aim of this study is to investigate the effect of patterned distribution stimulation~     compared to conventional stimulation in reducing muscle fatigue during functional electrical~     stimulation (FES) following spinal cord injury (SCI).~   "
23844|NCT03254849|"~     In this study the effects of the Inhibition of the Sodium-Glucose Linked Transporter 2 in the~     kidney with empagliflozin compared to hydrochlorothiazide on blood pressure and on central~     sympathic nervous activity will be examined.~   "
23845|NCT03254836|"~     Objective The objective of the current trial is to investigate the effect of perioperative~     sleep and circadian rhythm on the natural course of survival among patient diagnosed with~     colorectal cancer. Concurrently, outcome measures like depression, fatigue, quality of life,~     and co-morbidity will be measured continuously in the short-, intermediate- and long-term~     period following diagnosis.~      The a-priori hypothesis is that preoperative sleep and circadian disturbances is a prognostic~     marker of reduced overall survival. Likewise, preoperative sleep-wake disturbances at~     baseline are expected to result in overall universally reduced quality of life, increased~     depression and fatigue. Furthermore, development of sleep-wake disturbances in the~     postoperative period as compared to preoperative sleep-wake rhythm is expected to a~     prognostic marker of negative outcomes.~      Target and study population The study population are all patients diagnosed with colorectal~     cancer in Region Zealand recruited consecutively from the trial initiation until study end~     each patient with an intended 5 year follow-up period. All available cases will be included~     in the trial.~      Study design The study will be an observational prospective cohort study applying a~     longituditional repeated measure design.~      Exposures and outcomes of interest The primary outcomes in the trial are sleep and circadian~     outcomes measured via actigraphy in the perioperative period.~      Furthermore, cancer related survival and overall survival in the 5 year follow-up period is~     considered primary outcomes.~      Secondary outcomes consist of consecutively measured depression, fatigue, quality of life,~     follow-up treatment and co-morbidity.~      Exposure variables are primary related to the cancer, i.e. cancer stage, surgical treatment,~     oncological treatment, baseline co-morbidity and pharmacological treatment. Some of the~     secondary outcomes could be expected to serve as confounding or mediating factors.~      Meaningful control for confounding will in the analysis phase be cancer stage and baseline~     sleep-wake rhythm status.~      Sampling methods All available cases will be sought included in the trial. No formal sample~     size has been performed and continues inclusion into the trial will be performed during an~     1,5 year period.~      Statistical analyses The relationship between overall survival and baseline sleep-wake rhythm~     will be investigated using survival statistics and/or multivariate logistic regression.~      Expected results The investigators expect to see a marked difference in overall survival~     among patients with sleep and circadian disturbances at baseline.~   "
23846|NCT03254823|"~     This study investigates whether there is an immune response directed against gut microbes or~     food and parts of the body in severe Myalgic Encephalomyelitis/Chronic Fatigue Syndrome~     (ME/CFS) patients.~   "
23847|NCT03254810|"~     This is a single site, parallel randomized, double blinded comparison of the safety,~     pharmacokinetics, and immunogenicity of a single 0.57 mg/kg dose of SYN060 to a single 0.57~     mg/kg dose of adalimumab (Humira®) reference product from North American and European~     sources. The study is open to healthy individuals on no medications that might confound the~     results of this safety study.~   "
23848|NCT03254797|"~     Does a 4-week stepping training program with or without external feedback clinically change~     functional ability and reduce risk of fall of ambulatory patients with iSCI?~      Are there significant differences between 4-weeks stepping training with or without external~     feedback in ambulatory patients with iSCI?~   "
23849|NCT03254784|"~     The purpose of this study is to evaluate BMS-986165 tablet formulation versus BMS-986165~     capsule formulation. This study will also evaluate the effect of a high-fat/ high-calorie~     meal and increased gastric pH on the BMS-986165 tablet formulation.~   "
23850|NCT03254771|"~     The main goal of this study is assess the effectiveness of a DA for patients with knee~     osteoarthritis candidates to ART~   "
23851|NCT03254758|"~     This is a first-in-human Phase1/2 study of ADR-001, adipose-derived mesenchymal stem cells~     (AD-MSCs). The safety and preliminary efficacy are evaluated in Phase 1 in patients with~     liver cirrhosis caused by Hepatitis C or Nonalcoholic Steatohepatitis and a recommended Phase~     2 dose is determined by the evaluation. The exploratory efficacy and safety are investigated~     against the same target population in Phase 2.~   "
23852|NCT03254745|"~     Rheumatoid arthritis is an auto-immune disorders that mainly affects the joints. It may also~     affect other organs of the body such as skin, eyes, lungs and heart. The immune system of the~     body attacks the lining of the joint that results in erosion and joint deformity. This~     condition if untreated may lead to disability. RA is managed by medications known as disease~     modifying anti rheumatic drugs (DMARDs) as well as physical therapy. Dietary and lifestyle~     modification may also ease the condition.~   "
23854|NCT03254719|"~     The primary objectives of this pilot trial are to evaluate the feasibility, safety and~     acceptability of an integrative care pathway that includes chiropractic care, for the~     coordinated care for Veterans Administration (VA) patients with chronic low back pain (cLBP),~     with an emphasis on those with mental health comorbidity, in preparation for the conduct of~     an appropriately powered multi-site randomized controlled trial (RCT). The secondary~     objectives are to collect study outcomes at the baseline visit (BV) and at weeks 3, 5, 7, and~     10 to: 1) assess the success of collecting outcomes; 2) determine the outcome measures to use~     in a future RCT; and 3) determine preliminary intervention effect sizes and variability to~     aid in sample size determination for a future RCT. The investigators hypothesize that~     chiropractic care offers relief for pain and mental health symptoms through the direct~     effects of treatment-focused CMT, as well as through the indirect, non-specific effects of~     the team-based relationship with the clinician.~      This pilot study is a single-arm trial. All participants will be asked to complete study~     outcomes which include the Roland Morris Disability Questionnaire (RMDQ), LBP intensity and~     interference as measured by the Defense and Veterans Pain Rating Scale (DVPRS), as well as~     the Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder 7-item Scale~     (GAD-7), Alcohol Use Disorders Identification Test (AUDIT), Post-traumatic Stress Disorder~     Checklist-Civilian Version (PLC-C), self-care behaviors, Keele Start Back Screening Tool~     (STarT Back), Healing Encounters and Attitudes Lists (HEAL), Expectations for Complementary~     and Integrative Treatments Questionnaire (EXPECT), and Pain Intensity, Enjoyment of Life,~     General Activity Assessment Tool (PEG) questionnaires, and the Pain Assessment Screening Tool~     and Outcomes Registry (PASTOR) assessment, which includes measures of pain, disability,~     mental health, quality of life enjoyment and satisfaction. All participants will receive up~     to 10 weeks of chiropractic care and will complete outcome assessments at weeks 3, 5, 7, and~     10 of the study.~   "
23855|NCT03254706|"~     Objective: This double-blind randomized clinical trial evaluates the influence of increased~     application time of a new etch-and-rinse two-step adhesive Single Link; (Angelus Dental~     Products Industry) applied in non-carious cervical lesions (NCCLs).~      Methods: A total of 221 restorations were randomly placed in 35 patients assigned in four~     groups to two different etch-and-rinse two-step adhesive Peak® Universal Bond (P) (Ultradent~     Products Ind) and Single Link (SL) (Angelus Dental Products Industry). The adhesives systems~     were applied on the NCCLs follows: P1 - applied according to the manufacturer's; P2X -~     applied for the double time; SL1 and; SL2X. The resin composite Amelogen (Ultradent) was~     placed incrementally. The restorations were evaluated imediataly (baseline), 6 and 12 months,~     using the FDI and USPHS criteria. Statistical analyses were performed using appropriate tests~     (=0.05).~   "
23856|NCT03254693|"~     Objective: This double-blind randomized clinical trial evaluates strategies for improving the~     bonding of universal adhesive to enamel in non-carious cervical lesions (NCCL) of a new~     universal multi-mode adhesive (Ambar Universal; FGM).~      Methods: A total of 134 restorations were randomly placed in 19 patients according to the~     following groups: SE - Self-etch; SEE - Selective etching; SE2X - Self-etch doble time; SE1+~     - Self-etch additional layer. The resin composite Opallis (FGM) was placed incrementally. The~     restorations were evaluated after one week (baseline), 6 and 12 months, using the FDI and~     USPHS criteria. Statistical analyses were performed using appropriate tests (=0.05).~   "
23857|NCT03254680|"~     This is a single center open-label pilot clinical trial of patients 1-70 years of age with~     greater than 6 seizures per month diagnosed with Dravet Syndrome, Lennox-Gastaut Syndrome,~     Tuberous Sclerosis, or focal seizures. Twenty patients will be enrolled and treated with a~     stable dose of orally administered turmeric oil daily for 3 months. Patients and caregivers~     will be asked to keep a seizure diary logging all clinical events during the course of the~     study. Serum comprehensive metabolic panel, complete blood count with differential, and~     antiseizure medication levels, will be monitored at baseline, 1.5 months, and at the end of 3~     months.~   "
23858|NCT03254667|"~     Prospective, Observational Study to Assess the Long-Term Safety of Brodalumab Compared with~     Other Therapies in the Treatment of Adults with Moderate-to-Severe Psoriasis~   "
23859|NCT03254654|"~     Vinorelbine Plus Apatinib Versus Vinorelbine in Advanced Triple-Negative Breast Cancer~   "
23860|NCT03254641|"~     We have in a pilot study found that serum calcium levels change in response to hCG~     stimulation test. We observed that serum calcium level measured at baseline and 72 hours~     after hCG stimulation were different in men with gonadal insufficiency referred for this~     stimulation test. Now we want to investigate a large cohort of men referred for hCG~     stimulation test due to suspected impaired gonadal function.~   "
23861|NCT03254628|"~     The study aims are to evaluate the impact of supportive follow-up strategies for a novel~     twinned training and capacity-sustaining program among frontline health workers (providers)~     attending facility-based births in remote and district level health facilities in Uganda. The~     program is designed to improve provider competencies, provider performance and health~     outcomes among women giving birth and newborns.~   "
23862|NCT03254615|"~     The current project seeks to evaluate the effectiveness of numerous educational strategy~     interventions to increase the percentage of water consumed among early elementary school~     students over a 1-year period.~   "
23863|NCT03254602|"~     A clinical trial evaluating the effectiveness, safety and patient tolerance for the use of~     Intense Therapeutic Ultrasound (ITU) for chronic, Plantar Fasciitis musculoskeletal tissue~     pain reduction began in August 2016 and was completed in April 2017. The clinical setting:~     University Foot and Ankle Institute, Santa Monica, California, USA; Single-Blinded, pivotal~     study for chronic plantar fasciitis.~   "
23864|NCT03254589|"~     The investigators will study the effects of methotrexate on blood pressure, arterial~     stiffness and endothelial function in patients with rheumatoid arthritis.~   "
23865|NCT03254576|"~     The objective of the study is to compare children at low risk for obesity (two healthy weight~     parents) to children at high risk for obesity (two overweight parents) in their response rate~     to food taste and in their rate of learning using fMRI.~   "
23866|NCT03254563|"~     Copeptin, a surrogate marker for vasopressin, has been found to be elevated in metabolic~     disorders including obesity and diabetes, which are disorders both associated with~     nonalcoholic fatty liver disease (NAFLD), and therefore suggest a potential role for~     vasopressin in the pathogenesis of NAFLD. The investigators intend to investigate if there is~     an association of vasopressin with the presence and severity of NAFLD.~   "
23867|NCT03254550|"~     An 18 month observation cohort study with the overall aim to assess the operationalization of~     oral Pre-exposure prophylaxis (PrEP) in Swaziland as an additional HIV combination prevention~     method among population groups and individuals at high risk of HIV infection.~   "
24031|NCT03252418|"~     Vitamin C affect the melanocytes function not the number while diode laser cause melanocytes~     destruction. Although diode laser and vitamin C have proved their effectiveness in~     depigmentation in previous studies, there are no published studies compared the effect of~     diode laser and vitamin C on melanocytes and melanosomes clinically and histologically.~   "
23868|NCT03254537|"~     Results from a small number of human cohort studies are also available and indicate that~     there are positive associations between organic food consumption and reduced risk/incidence~     of certain acute diseases (e.g. pre-eclampsia, hypospadias) and obesity/overweight.~      Results from animal dietary intervention studies suggest that (i) switching to organic food~     consumption results in significant changes in hormonal balances and an increase in immune~     system responsiveness and (ii) differences in pesticide residue, cadmium, protein and~     antioxidant concentrations between organic and conventional foods are major drivers for~     hormonal balances and immune system parameters in animals.~      However, there is virtually no published data from (i) long-term cohort studies focusing on~     chronic diseases (e.g. cardiovascular disease, diabetes, cancer and neurodegenerative~     conditions) and (ii) controlled human dietary intervention studies comparing effects of~     organic and conventional diets. It is therefore currently not possible to assess whether and~     estimate to what extent organic food consumption may affect human health.~   "
23869|NCT03254524|"~     The goal of this study is to create predictive models of emergency care and metrics for~     population health that can be used to analyze how events like hospital closures or disasters~     like Hurricane Sandy affect health care utilization by patients in specific populations or~     geographic regions. Additionally, it will allow the development of metrics for population~     health that can act as surveillance mechanisms to measure disease prevalence and identify~     patterns in emergency department use that can be used to identify specific geographic regions~     where health care is either optimized to promote health or needs to be improve so that~     population health can be improved.~   "
23870|NCT03254511|"~     This is a randomized, single blind, multi-center, phase two clinical trial. Inclusion~     criteria are consist of non-metastatic esophageal cancer who are going to receive~     chemo-radiotherapy. Sample size is 100 people (50 people in each group). In the intervention~     group, patients are going to inject an enoxaparin (40 mg) daily concurrent by~     chemo-radiation. Therefore patients with esophageal cancer are going to assign randomly to~     control group (only chemo-radiotherapy) and intervention group~     (chemo-radiotherapy+enoxaparin) using 1:1 allocation. Four to 6 weeks after treatment, all~     patients undergo upper GI endoscopy and then esophagectomy. Endoscopic and pathological~     findings (after esophagectomy) are considered as clinical and pathological response,~     respectively.~   "
23871|NCT03254498|"~     A randomised back to back study comparing cap and Endocuff to detect adenomas during~     colonoscopy~   "
23872|NCT03254485|"~     The objective of the CAPACITY-HFpEF study is to evaluate the safety and efficacy of 3 dose~     levels of IW-1973 compared with placebo when administered daily for approximately 12 weeks to~     patients with HFpEF. The study will evaluate the effect of oral IW-1973 on peak exercise~     capacity in patients with HFpEF, with or without permanent or persistent atrial fibrillation.~   "
23873|NCT03254472|"~     The investigators conducted a retrospective analysis of all measured concentrations performed~     in a large subset of laboratories located in the French Brittany from February 2010 the 17th~     to August 2015 the 30th, in adults over 20 years old.~      The investigators are aimed at studying physicians' use and eventually misuse of biomarkers~     dosage and the characteristics of a broad population based on some biomarkers concentrations.~   "
23874|NCT03254459|"~     This study will evaluate the safety and tolerability based on the incidence of adverse~     experiences of buprenorphine sublingual spray (0.5 mg three times daily [TID]) compared with~     standard post-operative narcotic therapy in participants with postoperative pain. Standard~     post-operative narcotic therapy is defined as morphine intravenous injection (IV) (4 mg TID)~     followed by oxycodone hydrochloride tablet (10 mg TID).~   "
23875|NCT03254446|"~     The phase III trial is designed with an aim of determining the efficacy of Investigational~     Product TRC150094 in concurrently reducing non-traditional risk factors for CV risk i.e.,~     HbA1c, MAP and non-HDL cholesterol. This study will be a randomized, double blind, parallel~     group, placebo controlled, multi-centre, multinational study in 1250 subjects. All the study~     subjects will receive once daily dose of TRC150094 45 mg or placebo tablets in addition to~     their standard of care, for 24 weeks followed by roll over to a safety extension phase of 26~     weeks.~   "
23876|NCT03254433|"~     This research study is a sub-study within the Behavioral Activation for Smoking Cessation and~     the Prevention of Post-Cessation Weight Gain main study (NCT02906787). Participants who are~     eligible for the main study and meet certain MRI (Magnetic Resonance Imaging) related study~     criteria (i.e. conditions) may also elect to complete a series of computer tasks inside a~     standard, closed MRI scanner to examine changes in brain activity associated with the smoking~     cessation counseling that participants will receive in the main study. In total, participants~     will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling~     session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment~     period.~   "
23877|NCT03254420|"~     The Calypso® System (Varian Medical Systems, Inc., Palo Alto, CA) is a recent technology~     using electromagnetic transponders implanted within the prostate. It is a real-time target~     tracking system that takes into account both inter- and intrafractional target motion. So the~     exact position and movement of the prostate can be determined during radiation therapy~     treatment.~      The aim of this study is to assess pelvic late toxicity rate after intensity-modulated~     radiotherapy (IMRT) when using the Calypso® System with a reduction of treatment margins. In~     this randomized study, patients will receive IGRT treatment using the Calypso system or a~     conventional IGRT treatment.~   "
23878|NCT03254407|"~     The goal of this study compare the effectiveness of an electronic note versus a telephone~     call to alert the prescriber of a possible IV to oral switch. Secondary endpoints are the~     time-to-switch and the economic impact of earlier IV to oral switch.~   "
23879|NCT03254394|"~     Oxaliplatin-induced neuropathy is a major dose-limiting side effect in patients with~     colorectal cancer treated with the FOLFOX chemotherapy regimen. Hypersensitivity to cold is~     the sensory hallmark of oxaliplatin-induced neuropathy, and it can predict the development of~     long-term neuropathy. In this study, the investigators aim to determine whether intravenous~     lidocaine can prevent oxaliplatin-induced cold hypersensitivity.~   "
23986|NCT03253003|"~     A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted~     on hard of participants with a hearing loss to grant quality control prior to product launch.~     The aim of the investigation series is to ensure a stable overall performance of the new~     hearing systems, a good sound quality during phone calls as well as maximum benefit for the~     participant with the devices.~   "
23880|NCT03254381|"~     Older adults with type 2 diabetes experience cognitive decline and are at higher risk for~     developing dementia. Consequently, older adults at-risk for developing type 2 diabetes (based~     on body mass, glucose levels) are at higher risk for cognitive decline, and intervening at~     this point may prevent or delay the onset of such decline. One promising lifestyle~     intervention that has been shown to improve cognitive function in other populations is~     exercise. However, before investigators can examine whether exercise will improve cognitive~     function and brain health (structure and function) in this at-risk population, a feasibility~     pilot study is needed to determine whether a larger-scale trial would be viable.~   "
23881|NCT03254368|"~     The purpose of this study is to evaluate the efficacy and safety of the study drug ZGN-1061~     in participants with type 2 diabetes.~   "
23882|NCT03254355|"~     Childbirth is a major risk factor for pelvic floor muscle (PFM) trauma. In one third of~     women, stretching of the PFM will result in an avulsion injury (i.e. disconnection of the~     muscle from its insertion points on the pubic symphysis). Recent advances in imaging have led~     to the discovery of this previously unknown major injury and further research now enables its~     diagnosis with readily available techniques. Avulsion injury has alarming consequences~     because it has been associated with a higher rate of urinary incontinence in the postpartum~     period as well as the long-term development of other major urogynecological conditions such~     as pelvic organ prolapse and anal incontinence. Women with avulsion not only suffer from~     severe symptoms with significant related impacts on physical activities, overall well-being~     and quality of life, but they also present a higher rate of surgical failures. Moreover, it~     is still unknown whether the most recommended first-line treatment for urinary incontinence~     -PFM physiotherapy- is effective in women with this major trauma. Until now, only a pilot~     study conducted by our team supports the rationale and the efficacy of physiotherapy for~     improving PFM function in women with avulsion, despite their major muscle injury.~      Primary objective: To evaluate the efficacy of physiotherapy for urinary incontinence in~     women with avulsion at 9-months after randomization compared to a waiting-list control group.~      Secondary objectives:~        1. To compare physiotherapy to the control group after treatment and at 9-months after~          randomization in terms of: a) incontinence and prolapse (objective quantification,~          symptoms and related impact); b) PFM morphology and function; c) sexual function; d)~          self-efficacy; e) cost analysis; f) treatment satisfaction and impression of change.~        2. To investigate the impact of the severity of the avulsion (i.e. unilateral or bilateral)~          on the response to physiotherapy treatment on the aforementioned outcomes.~   "
23883|NCT03254342|"~     We hope to demonstrate that magnetic resonance spectroscopy can detect brain concentration~     levels of paroxetine (Paxil) or citalopram (Celexa) or escitalopram (Lexapro) in depressed~     patients.~   "
23884|NCT03254329|"~     The primary purpose of the proposed research is to establish Reference Values (RVs) for~     micronutrients (MN) and macronutrients in human milk. The investigators' research to date has~     revealed highly variable milk MN concentrations among populations, and very low values in~     some low income countries (LICs) likely caused by poor maternal status and/or diet but RVs~     are needed to interpret these values. During the past year the investigators conducted a~     review of human milk nutrient composition, and formed a Technical Advisory Group (TAG) which~     developed the current proposal. Here, the investigators are conducting a longitudinal project~     on well-nourished women and infants. The Mothers, Infants and Lactation Quality (MILQ) study~     is a multi-center cohort project, investigating breast milk nutrient composition in~     well-nourished women across the first 8.5 months of lactation in four different populations.~     The countries involved are Denmark, Brazil, Bangladesh and The Gambia. Exclusive~     breastfeeding is an eligibility criterion up until the second post-partum study visit~     (between 1 - 3.4 months postpartum), with the exception of the first week after delivery.~     Other data collected on mothers and infants, including maternal and infant nutrient intake~     and status, morbidity, milk volume, and infant development, will inform interpretation and~     support application of the results. While the priority is to develop RVs for MN, other~     analyses will include human milk oligosaccharides (HMOs) and proteins, and free amino acids~     (FAA) in infant plasma. Thus, with the samples obtained the investigators will perform (a)~     laboratory analyses of milk, plasma and urine nutrients to construct RVs for global~     application, (b) analyses of HMOs and proteins in milk, and (c) metabolomic analysis of FAA~     and other metabolites in infant plasma. By request of the Bill and Melinda Gates Foundation~     (BMGF), colostrum and fecal microbiota samples will also be collected and stored for later~     analyses.~   "
23885|NCT03254316|"~     Healthcare - Associated Infection Surveillance In Neonatal Intensive Care Unit of Assiut~     University Children's Hospital.The objective of study is to determine the incidence,~     infection sites, causative organisms and risk factors related to healthcare-associated~     infections in NICU in Assiut University Children hospital.~   "
23886|NCT03254303|"~     This interventional simple-blind,randomized trial has included 90 children of American~     Society of Anesthesiologist (ASA) physical status I or II aged between 1 to 12 years of~     either sex, scheduled for for outpatient minor surgery under general anesthesia. This study~     examined whether one should make iv attempts during the early induction period (at 60~     seconds) or lately (90 or 120 s) and waiting until the child receives additional sevoflurane~     inhalation anesthesia.~   "
23887|NCT03254290|"~     This randomized control study will use 15 pediatric subjects selected from the patient~     population in the pediatric dental clinic at Children's Medical Center Dental Clinic (CMC~     Dental Clinic). The study will use a within-subject control design whereby one tooth will be~     treated with a pulpotomy using the new formulation of MTA (NeoMTA Plus, Avalon Biomed Inc.,~     Bradenton, FL, USA) and restored with a multi-surface composite, and the other tooth with a~     formocresol pulpotomy and restored with a multi-surface composite; thus, approximately 15~     teeth will be treated for each treatment group. The specific treated tooth will be randomized~     as to which side will receive the MTA or formocresol using sealed, opaque envelopes.~     Approximately 15 subjects will be needed for the study in order to elicit any significant~     findings as demonstrated by a power analysis.~   "
23888|NCT03254277|"~     This study is a phase 1, open label, dose-escalation study of the mAb 3BNC117-LS administered~     intravenously in HIV (human immunodeficiency virus)-uninfected individuals and HIV-infected~     individuals. The objectives of the study are to evaluate the safety, tolerability and~     pharmacokinetics of a single infusion of 3BNC117-LS in HIV-uninfected and HIV-infected~     individuals.~   "
23889|NCT03254264|"~     The Early start Denver model (Rogers, 2010; Dawson, 2010) is a developmental and behavioral~     model that aim to enhance socio-comunicative abilities and also global development of~     children with Autism spectrum disorder (ASD). The purpose of this study is to identify~     changes in neurocognitive profile of children population with ASD receiving Early Start~     Denver Model (ESDM) applied 12 hours per week in comparison to children receiving other~     interventions. That is a study proposed to children with ASD and their families that~     participate already to a randomized control study called IDEA registered on~     clinicaltrials.gov NCT02608333.~      the investigators hypothesized that ESDM would increase social cognition, reduce shifting~     attention time and increase preference for unpredictable stimuli.~   "
24007|NCT03252730|"~     The aim of the study is to evaluate the tolerance of the product WO 4260 by a dermatologist.~     Additional objectives of this clinical in-use study are to evaluate the cosmetic features and~     acceptance of the product by means of a questionnaire in an interview situation and by skin~     hydration measurements on the scalp.~   "
23890|NCT03254251|"~     We used a parallel experimental design. Following an initial screening and familiarization~     session of study tests and procedures, eligible postmenopausal women were randomly assigned~     to a stair climbing (SC) group or non-exercising control group. SC training session was~     progressive program, and was performed 4 days a week for 12 weeks. Measurements were~     collected at baseline and after 12 weeks during the same time of day (±1 hour) in the morning~     following an overnight fast and abstinence from caffeinated drinks, alcohol, and between 48~     and 72 hours after the last exercise session.~   "
23891|NCT03254238|"~     Prescription drug abuse is a major challenge in public health, in particular in countries~     such as France, one of the main consumers of medication in Europe. A single source of~     information is rarely sufficient to measure such a complex phenomenon. This project entitled~     MEGADOSE (Monitoring prEscriptiondruG Abuse using DOctor Shopping bEhavior) may complete~     efficiently the available data from the addictovigilance centres allowing the health~     authorities (French Drug Agency) to answer to the main general questions (What are the main~     prescription drug abused in France? What are the national trends in prescription drug abuse?~     What is the impact of a public health measure on prescription drug abuse). This project~     constitutes the opportunity of extending the application of our tool (the DS method) on a~     French national database with a minimal risk since this method has already been validated and~     applied on different geographic areas, on different drugs and at different levels of~     analysis. The project would also be integrated in routinely as a useful tool included in the~     addictovigilance monitoring, also allowing a multi-approach approach and the monitoring of~     policy and practice interventions implemented by the French Drug Agency.~      The project MEGADOSE is also in accordance with the main topic of the projects funded by ANSM~     related to drug misuse in particular: development and identification of systems and tools~     able to detect earlier misuse phenomenon; analysis of the impact of communications,~     guidelines, decisions to health authorities and patients~   "
23892|NCT03254225|"~     This study evaluates the inffluence of 16 weeks of resistance training on heart rate~     variability of hypertensive elderlies patients. All volunteers will be divided in two groups,~     one will participate in a protocol of sixteen weeks of resistance training, an the other will~     remain sedentary.~   "
23893|NCT03254212|"~     The aims of this study are to 1) determine the optimal levels of O2 flow which prevent~     nocturnal O2 desaturation while minimizing periods of hyperoxia during the course of~     nocturnal oxygen therapy (NOXT) in heart failure patients with reduced ejection fraction~     (HFrEF) patients with CSA/CSR; 2) document whether within-patient EO2F values change over~     time during NOXT, and identify factors which predict changes in EO2F; and 3) examine how well~     a conventional stepwise titration procedure compares to a breath by breath titration using an~     automated O2 titration system in terms of targeted flow rate and night time oxygenation~     (oxygen desaturation index, time spent at specific SpO2 targets).~   "
23894|NCT03254199|"~     The COMMIT Study will assess the safety and effectiveness of FLX-787 in men and women with~     Charcot-Marie-Tooth disease (CMT) experiencing muscle cramps. Participants will be asked to~     take two study products during the course of the study. One of these study products will be a~     placebo.~      Approximately 120 participants in 20 study centers across the United States are expected to~     take part. Participants will be in the study for approximately 3 months and visit the study~     clinic 3 times.~   "
23895|NCT03254186|"~     Tardive dyskinesia (TD) is a disabling, embarrassing and often irreversible iatrogenic~     movement disorder that can occur in anyone exposed to drugs that block dopamine receptors,~     including first and second generation antipsychotics and antiemetic agents. There is no way~     to prevent TD except preventing exposure to the inciting agents and there are no approved~     symptomatic therapies. Propranolol is an FDA-approved β-blocker with limited data supporting~     its use as a treatment for TD.~      The goal of this study is to determine the efficacy of propranolol in the treatment of TD in~     a double-blind, cross-over prospective manner. If propranolol is found to be an effective~     therapy, it will fulfill a great need in the treatment of TD with a medication that is known~     to be safe and inexpensive.~   "
23896|NCT03254173|"~     A randomized controlled clinical trial will be conducted to assess the efficacy of the FDA~     approved drug , mirtazapine , in treatment of cancer associated anorexia cachexia syndrome.~      Two arms will be compared . Arm A will involve 50 patients with confirmed advanced cancer~     receiving mirtazapine 15 mg once daily for 8 weeks & Arm B will involve another 50 patients~     with confirmed advanced cancer receiving placebo for 8 weeks.~      Both arms will be compared to assess efficacy of mirtazapine in appetite stimulation~     primarily and to assess other outcomes secondarily which will be discussed later in details.~   "
23897|NCT03254160|"~     This is a randomized, double-blind, placebo-controlled parallel group outpatient 42-day~     treatment study that will utilize standard stroke rehabilitation outcome measures to evaluate~     the effect of DNS-3379 on upper extremity motor recovery in subjects following ischemic~     stroke.~   "
23898|NCT03254147|"~     This is a retrospective, observational, claims cohort study to assess, for adult patients~     initiating an oral anticoagulant for NVAF~   "
23899|NCT03254134|"~     This is a comparative effectiveness and safety study of clinical events among patients taking~     either dabigatran or warfarin. There is no formal hypothesis to be tested, but rather to~     provide the estimates on the incidence of stroke and systemic embolism (effectiveness) and~     bleeding events (safety) using 95% confidence interval for comparison between those~     non0-valvular atrial fibrillation patients taking dabigatran vs. warfarin using a large,~     nation-wide claims data in Japan.~   "
23900|NCT03254121|"~     In this international collaboration study, the research group will analyze somatic mutations~     of hepatocellular carcinoma (HCC) developed after sustained virological response (SVR) in~     patients treated with hepatitis C (HCV) therapy~   "
23901|NCT03254108|"~     The dose for intravenous administration of OPC-61815 achieving tolvaptan exposure equivalent~     to that for oral administration of tolvaptan 15-mg tablet will be investigated by~     administering OPC-61815 injection 2 to 16mg or tolvaptan 15-mg oral tablet to subjects with~     congestive heart failure.~   "
24008|NCT03252717|"~     To confirm the protein expression level in radiation-induced late effects patients and to~     determine the performance value, in particular the positive predictive value, of a blood test~     based on the dosage of a panel of five proteins, it is necessary to validate these~     preliminary results by a prospective study on a large cohort of patients.~   "
23902|NCT03254095|"~     Diabetes is a chronic disease with increasing prevalence worldwide with a high burden to~     individuals and the society and it is expected to be the 7th leading cause of death in 2030.~     Diabetes related complications manifest in many body parts, often in the foot, due to reduced~     blood flow and nerve damage, increasing the risk of ulcers and amputation. High plantar~     pressures during walking contribute to the development of foot ulcers and foot ulcer~     recurrence. Emerging studies also point skin temperature as another predictor of foot~     ulceration. However, the number of studies including prediction models of plantar pressure~     and skin temperature are scarce, especially in patients with confirmed diagnosis of diabetic~     foot and a history of foot ulcer. Factors like mobility, hardness of plantar soft tissue,~     foot deformities and other diabetes related characteristics have been related to plantar~     pressure measurements but not to foot skin temperature measurements, and the relation between~     skin temperature and plantar pressure has not been much explored in the literature. The role~     of these variables in the development of foot ulceration needs further attention, especially~     in patients with history of foot ulcers has they are at the highest risk to develop a foot~     ulcer.~      Therefore, the goal of this research is to determine which variables can be used to predict~     plantar pressure and skin temperature and which factors are associated with the development~     of foot ulcers in patients with established diagnosis of diabetic foot. The associations~     between skin temperature and plantar pressure will also be addressed.~   "
23903|NCT03254082|"~     Given the interest in gluten-free foods and discovering dietary means to prevent metabolic~     disorders, this study was designed to determine the glycemic responses of four (4) grains and~     flours (corn, rice, wheat, and sorghum). The grain products (gruel) will be eaten by subjects~     and blood glucose will be collected prior to and after eating over the course of two hours. A~     dextrose solution, dosed to provide a like amount of available carbohydrate, will serve as~     the control treatment.~   "
23904|NCT03254069|"~     The aim of this study was to determine if restoring primary molars with SSCs would improve~     children's OBF.~   "
23905|NCT03254056|"~     This study compares post-operative incisional pain on post-operative days 1 and 7 who will~     undergo gynecologic laparoscopic operations. Half of participants will undergo conventional~     fascial closure, while the other will undergo fascial closure by Berci Fascial Closure (Karl~     Storz, Belgium).~   "
23906|NCT03254043|"~     This study will evaluate whether a commercially available, secure, electronic pill box is a~     feasible, acceptable, and satisfactory method to manage take-home dosing of methadone for~     both methadone clinic patients and staff members.~   "
23907|NCT03254030|"~     This is a prospective randomised controlled trial to assess an intervention of inspection~     during both phases of colonoscopic examination ( insertion and withdrawal) improve adenoma~     detection rate when compared to inspection only during withdrawal.~   "
23908|NCT03254017|"~     The habenula(Hb) is an epithalamic structure located at the center of the dorsal diencephalic~     conduction system, a pathway involved in linking forebrain to midbrain regions. An increasing~     number of studies indicates that that overactivity in the lateral habeluna(LHb) is present~     during depressed states, where it could drive the changes in midbrain activity linked to~     depression. Deep brain stimulation(DBS) of the major afferent bundle (i.e., stria medullaris~     thalami) of the LHb can treat treatment-resistant major depression(TRD). There is no clinical~     case of directly stimulating habeluna for treatment TRD. This research will investigate~     effectiveness bilateral DBS to habenula for patients with TRD.~      Programming is a crucial aspect of DBS which directly influences its therapeutic efficacy.~     Researchers need to ascertain optimum stimulation parameters to help patients achieve optimal~     control of clinical symptoms. Remote programming of DBS can markedly improve patient~     convenience, minimize risk of infection and total treatment time and lead to an overall~     benefit for doctors and patients alike. This research will also investigate safety and~     benefit of remote programming of DBS.~   "
23909|NCT03254004|"~     A single center, open-label, single arm study in patients who have solid or micropapillary~     adenocarcinoma with pathologic stage I and primary tumor no more than 4 cm. Pembrolizumab 200~     mg every 3 weeks~   "
23910|NCT03253991|"~     A Study to Evaluate the Effectiveness and Safety of ExAblate Transcranial MRgFUS Thalamotomy~     Treatment of Medication Refractory Essential Tremor Subjects~      The objective of this prospective, single-arm study is to test the efficacy of treatment~     using the ExAblate Transcranial System and to further demonstrate safety in~     medication-refractory tremor inpatients with essential tremor (ET).~      The Indications for Use claim for this system is as follows: Treatment of~     medication-refractory tremor in patients with essential tremor.~   "
23911|NCT03253978|"~     The study will examine stereotactic ablative body radiotherapy (SABR), a new technique to~     deliver radiotherapy to men with prostate cancer. In addition to this, it will look at the~     effect of SABR on levels of markers of radiation exposure and bowel damage, along with other~     potential markers of outcome and side effects. Quality of life and any side effects that~     develop during and after treatment will also be assessed.~   "
23912|NCT03253965|"~     The purpose of this study is to determine how using auditory cues of a metronome and music at~     various frequencies impacts the gait mechanics in people with Parkinson's disease when~     walking over ground and on a treadmill.~      The investigators will enroll a total of 40 participants: 30 subjects with a diagnosis of~     Parkinson's disease (10 in Stage 1, 10 in Stage 2, and 10 in Stage 3) and 10 unimpaired~     subjects.~      Participants will complete 7 different treadmill walking conditions and overground walking~     conditions while the investigators measure step length, cadence, gait speed, and variability~     of movement.~   "
23913|NCT03253952|"~     The study is designed to investigate whether autonomic shifts (dysautonomia, sympatho-vagal~     instability) that develop after SCI have value in predicting SCI-associated infections~     (SCI-AI). SCI-AI impair outcomes by (1) reducing the intrinsic neurological recovery~     potential and (2) increasing mortality. Heart Rate Variability (HRV) data will be tracked in~     both the time and frequency domains to discriminate between the relative contribution of~     sympathetic and parasympathetic innervation to changes in HRV. The ability to predict~     infections will enable novel treatments thereby reducing infection-associated mortality and~     improving neurological and functional outcomes.~   "
24009|NCT03252704|"~     This randomized, double-blind, comparator controlled trial evaluated the blood glucose and~     insulin responses in healthy adults, after consuming a high fiber or low fiber muffin top.~   "
23914|NCT03253939|"~     Gastric cancer associated peritoneal carcinomatosis has a poor prognosis with a median~     survival of less than one year. Systemic chemotherapy including targeted agents has not been~     found to significantly increase the survival in Gastric cancer associated peritoneal~     carcinomatosis. Since recurrent gastric cancer remains confined to the abdominal cavity in~     many patients, regional therapies like aggressive cytoreductive surgery and hyperthermic~     intraperitoneal chemotherapy have been investigated for Gastric cancer associated peritoneal~     carcinomatosis. Hyperthermic intraperitoneal chemotherapy has been used for three indications~     in Gastric Cancer- as an adjuvant therapy after a curative surgery, hyperthermic~     intraperitoneal chemotherapy has been shown to improve survival and reduce peritoneal~     recurrences in many randomised trials in Asian countries; as a definitive treatment in~     established PC, hyperthermic intraperitoneal chemotherapy along with cytoreductive surgery is~     the only therapeutic modality that has resulted in long-term survival in select groups of~     patients. While the results of randomised trials of adjuvant hyperthermic intraperitoneal~     chemotherapy from western centres are awaited, the role of hyperthermic intraperitoneal~     chemotherapy in the treatment of Gastric cancer associated peritoneal carcinomatosis is still~     evolving and needs larger studies before it is accepted as a standard of care.~   "
23915|NCT03253926|"~     In this study, the investigators are interested in testing how lorcaserin influences the~     effects of cannabis in a human laboratory model of cannabis use.~   "
23916|NCT03253913|"~     RESULT is a phase II dose-escalating, open-label, safety and efficacy study to determine if~     there is a potential benefit of resveratrol in combination with sirolimus in patients with~     lymphangioleiomyomatosis (LAM). The primary study objective is to assess the change in serum~     vascular endothelial growth factor-D (VEGF-D) level after 24 weeks of treatment with a~     combination of resveratrol and sirolimus as compared to the VEGF-D level in patients on a~     stable dose of sirolimus alone. The secondary objectives of this study include an assessment~     of the safety and adverse effect profile of combined resveratrol and sirolimus in adult~     patients with LAM, and to determine the effect of treatment with a combination of resveratrol~     and sirolimus on changes in lung function and quality of life.~   "
23917|NCT03253900|"~     Rowing simulators are frequently used by rowers, when on-water training is impossible or~     limited. While such devices are highly valuable to maintain rowers` fitness, a concern was~     raised about extensive simulator usage. It was postulated that it could lead to technique~     alterations due to different biomechanical properties compared to on-water rowing.~     Slide-based rowing simulators were designed to better simulate on-water conditions.~      The main aim of the study was to compare the differences in various kinematic and kinetic~     parameters during a short (20 s) all-out rowing bout and during a 2000-m simulated race, to~     get a better insight into how different rowing simulator designs affect biomechanics of~     rowing.~      Three different rowing simulators were used in this study: (1) a standard stable/fixed rowing~     simulator, (2) a slides based rowing simulator, i.e. horizontal plane unstable, and (3) a~     tilt board based rowing simulator; i.e. frontal plane unstable.~      The investigators hypothesised that rowing on different simulators will elicit different~     biomechanics, including forces, power output, arm and seat movement velocity and amplitude.~      Each of the participants completed the tests in all three interventions on separate sessions;~     random order of interventions. The three sessions took place 7-10 days apart. During each~     session, the participants completed the all-out 20-s trial first, then the simulated 2000-m~     race. The aforementioned biomechanical parameters were tracked throughout the trials to be~     compared between interventions later.~   "
23918|NCT03253887|"~     Central venous catheter infection is a common complication in pediatric patients, resulting~     in prolonged length of stay in hospital, requiring antibiotics, invasive procedures and~     increase morbidity and mortality. Given the repercussion of this complication, measures that~     minimize its should be stimulated. The purpose of this study is to evaluate the effects of~     intraluminal alcoholization (ethanol lock therapy) on prevention of infection of short-term~     central venous catheters in pediatric patients.~   "
23919|NCT03253874|"~     A multi-disciplinary intervention will reduce inappropriate preoperative testing for cataract~     surgery. Despite multiple rigorous randomized controlled trials and meta-analyses showing~     that pre-operative testing for cataract surgery does not improve outcomes, pre-operative~     testing has not declined. A quality improvement initiative, which includes gaining senior~     leadership support, changing the culture of care, and elimination of pre-operative~     consultation visits for cataract surgery, to reduce inappropriate pre-operative testing.~     Quasi-experimental difference-in-difference analysis comparing the intervention arm (LAC+USC~     Medical Center) with the control arm (Harbor-UCLA Medical Center), 6 months prior and 6~     months after the intervention. Generalized estimating equation models will adjust for age,~     gender, race/ethnicity, comorbidities and cluster by site.~   "
23920|NCT03253861|"~     Severe acute pancreatitis is a common reason for intensive care unit (ICU) admission and is~     associated with prolonged hospital stays and high morbidity and mortality rates. The Atlanta~     classification differentiates mild, moderate, and severe acute pancreatitis, and each of~     these categories correlates with morbidity and mortality. Mortality remains high, between 10%~     and 39%, in severe and moderately severe acute pancreatitis. After the first week, about 30%~     of patients with necrotizing pancreatitis develop infected pancreatic necrosis (IPN). IPN is~     a risk factor for mortality.The treatment of IPN combines antibiotics with interventions to~     remove the infected intra-abdominal material, preferably using minimally invasive techniques~     such as percutaneous and endoscopic drainage, which have been proven beneficial. In several~     studies biological markers such as procalcitonin and interleukin 8 were effective in~     predicting IPN. However, few clinical risk factors for IPN have been reported. Identifying~     risk factors may help to improve standardized strategies for early diagnosis and treatment,~     and then patients outcome. Our primary objective was to identify risk factors for IPN in~     patients admitted to the ICU for acute pancreatitis. Our secondary objective was to describe~     the management and outcomes of IPN~   "
23921|NCT03253848|"~     This clinical trial studies how well simplified patient care strategy works in decreasing~     early death in patients with acute promyelocytic leukemia. Implementing simplified acute~     promyelocytic leukemia guidelines along with support from acute promyelocytic leukemia~     experts may decrease deaths and improve survival.~   "
24010|NCT03252691|"~     Lumbar discectomy study, collection and evaluation of incidence of large annular defects.~   "
23922|NCT03253835|"~     Various factors affect the performance of the heart: The contractile properties of myocardial~     muscle cells are the fundamental devices for translating tension-generation and shortening of~     the cardiac muscle into pressure-generation and blood volume ejection from the heart into the~     body. On the other hand, the performance of heart can be analyzed with respect to input and~     output of blood to/from the hollow cardiac muscle and evaluated in terms of the performance~     of a pump: With every heartbeat blood is sucked from a low-pressure system (veins) and pumped~     to the arterial high-pressure system via one-way valves, whereas efficiency, ejected blood~     volume, blood flow and pressures are linked by hemodynamic laws.~      Cardiac magnetic resonance (CMR) is the gold standard technique to determine cardiac~     function and muscle mass, as well as for non-invasive diagnosis of myocardial~     necrosis/fibrosis. Furthermore, new CMR imaging techniques enabling the measurement of~     myocardial magnetic relaxation times for characterization of myocardial morphology and the~     acquisition of time-resolved, three-dimensional blood flow velocity fields in the heart and~     surrounding vessels, represent promising tools for the evaluation of the interaction between~     myocardial morphology and cardiac function.~      Aim of this explorative study is to 1. identify myocardial pathology-associated blood flow~     patterns in the heart and surrounding great vessels, and 2. correlate characteristic blood~     flow patterns in the heat (existence of vortices, vorticity, vortex formation, propagation~     dynamics …) with myocardial injuries.~   "
23923|NCT03253822|"~     The aim of the trial is to test the effect of a web-based decision aid (DA) on colorectal~     cancer (CRC) knowledge, decisional conflict, participation rate, and informed choice~     (evaluated based on knowledge, attitudes and actual participation).~      The study includes three study arms. Citizens to be recruited are identified from the Danish~     Civil Registration System based on residence (Central Denmark Region), age (50-74 years old),~     and month of birth. A random sample of 15,000 citizens born in December (invited for CRC~     screening through October/November/December 2017) (study arm 1+2) and 5,000 citizens born in~     October (invited for CRC screening in January/February 2017) (study arm 3) is identified.~      Citizens in study arm 1+2 will receive a baseline questionnaire assessing knowledge,~     attitudes, worry, and health literacy. Non respondents will receive one reminder after two~     weeks and after four weeks non-respondents will receive a phone call, offering them to fill~     out the questionnaire via the phone. Baseline questionnaire respondents are included in the~     study, and will be randomized into two study arms (intervention group and control group).~      Citizens in the intervention group will be identified in the screening IT system. Date of~     screening invitation and screening reminder (citizens who do not return a stool sample within~     45 days of the screening invitation) is retrieved. Citizens receiving a screening reminder~     will receive a link for the DA. Follow-up questionnaire will be sent to all included citizens~     in study-arm 1+2 three months after the last screening invitation has been sent out. Citizens~     have six weeks to respond to the questionnaire.~      Study arm 3 is a historic cohort. The citizens receive only one questionnaire at the same~     time as the baseline questionnaires are sent out to the intervention and control groups. The~     citizens are included if they respond to the questionnaire within six weeks. Questionnaire~     reminders are sent out at two and four weeks.~      Data on screening invitation date, screening reminder date, returning a stool sample and~     result will be retrieved from the screening IT system for all included citizens (Study arm~     1-3). Lastly, data from Statistics Denmark (on socio-demographic and socio-economic factors)~     will be included.~   "
23924|NCT03253809|"~     LV pacing at various sites with recording of ECG and subsequent signal analysis at different~     sites.~   "
23925|NCT03253796|"~     The purpose of this study is to evaluate the effect of treatment withdrawal vs continued~     treatment with golimumab (GLM) administered by subcutaneous (SC) injection on the incidence~     of a flare in non-radiographic axial spondyloarthritis over up to 12 months. The primary~     hypothesis is that continued treatment with golimumab is superior to treatment withdrawal,~     based on the percentage of subjects without a flare during up to 12 months of blinded~     therapy.~   "
23926|NCT03253783|"~     This study uses a randomized controlled design to evaluate the efficacy of a new mobile app,~     Pulse, in reducing the incidence of unprotected sex among young women. Pulse is a web-based~     mobile health application that can be accessed through mobile smartphones and computers.~     Pulse was designed to increase highly effective birth control use and reproductive and sexual~     health care utilization, and ultimately decrease teen pregnancy. The sample is comprised of~     women with the following characteristics at study enrollment: aged 18-20, not pregnant or~     trying to become pregnant, has daily access to a smartphone, currently living in the United~     States or a U.S. territory, and speaks either English or Spanish. Most of the sample (at~     least 70%) will be women who identify as Black and/or Latina. The evaluation team plans to~     enroll up to 1,300 participants over a one-year enrollment period using social media,~     including Facebook, Instagram, and Twitter.~      Users access Pulse autonomously, on their own terms, and in their own time and place. The app~     consists of 6 sections and includes 3 hours of unique content. It does not require the user~     to follow a specific sequence of content viewed; however, all users will receive a monetary~     incentive after registering with the apps. Youth randomized to the intervention condition are~     given access to Pulse indefinitely and receive daily text messages related to sexual health~     for 6 weeks. Control participants are directed to a free general health/fitness web-based~     mobile application, also called Pulse, and receive text messages related to general health~     for 6 weeks. The control and treatment apps look and feel similar aesthetically but contain~     different content. Participants in both the intervention and comparison groups receive a~     baseline survey and a 6-week follow-up survey. Participants will also receive incentives once~     they complete the baseline and post-intervention survey. Both surveys are conducted online~     via an electronic survey platform. This study is being conducted as a Rigorous Evaluation of~     New or Innovative Approaches to Prevent Teen Pregnancy funded by the U.S. Department of~     Health and Human Services' Office of Adolescent Health.~   "
23927|NCT03253770|"~     Cardiac arrest is one of the most stressful situations to be managed. Our first study (MAX,~     accepted for publication BJA) clearly showed that it could not be compared to other urgent~     and stressful situations (malignant hyperthermia, anaphylactic shock, acute toxicity of local~     anesthetics, severe and symptomatic hyperkaliemia) whose management was significantly~     improved with the help of a digital cognitive aid.~      The present study exclusively deals with the management of cardiac arrest (recovery ward, or~     in the delivery room.) with the second generation of our digital cognitive aid, and explores~     new insights on how to better manage cardiac arrest with a digital cognitive aid in the hand~     of the leader.~   "
23932|NCT03253705|"~     Background:~      This study is designed to provide samples to help us study the genes your blood cells are~     making as well as the proteins, sugars, fats, vitamins and other metabolites found in your~     blood or urine. Blood samples may also be collected to make special cells. These are called~     induced pluripotent stem cells or iPSCs. Pluripotent stem cells are cells that can be~     converted into any type of cell. Researchers want to study in the lab iPSCs that are derived~     from blood samples.~      Objective:~      To collect samples to help study genes, proteins, sugars, fats, vitamins, and other~     metabolites found in blood or urine.~      Eligibility:~      Healthy volunteers and patients ages 18 and older~      Design:~      First-time research study participants at NIH will have an initial visit for this study that~     should last no more than 1 hour. All other visits should last 20 30 minutes.~      Participants will undergo a limited history and physical exam.~      Participants may have routine blood and urine tests.~      If participants are giving a blood sample, they must have a hemoglobin level checked in the~     past 12 months to make sure it is safe for them to give a blood sample for research.~      Participants may have a venous blood collection. They may do this at several visits. They~     will lie on a recliner or couch or sit in a chair. A needle will be placed into a vein in the~     hand or arm, using sterile techniques. Blood will be withdrawn into multiple syringes or~     tubes.~      Participants may be asked to provide urine in an appropriate container...~   "
23928|NCT03253757|"~     HIV pre-exposure prophylaxis (PrEP) is the use of anti-HIV medicines by HIV negative people~     in order to prevent them from becoming HIV positive if exposed to HIV.~      Currently, the combination drug containing tenofovir and emtricitabine is licensed in Europe~     for use as HIV PrEP. We know from previous studies worldwide that this combination drug is~     very good at reducing the risk of HIV infection and several countries have implemented PrEP~     programmes to provide PrEP to individuals at high risk of HIV.~      However, it is difficult to effectively plan for a national PrEP programme in England without~     knowing how many people will need PrEP, how many will want to take PrEP, and how long they~     will stay on PrEP.~      In order to find this out, the PrEP Impact Trial will make PrEP available to at least 10,000~     people over three years. HIV negative men and women attending sexual health clinics in~     England will have their risk of HIV assessed by their care team and be offered PrEP if they~     meet the eligibility criteria. Through the trial we will be able to measure how many~     attendees at sexual health clinics meet eligibility criteria for PrEP, how many of these take~     up the offer of PrEP and how long they remain on PrEP for.~      There will not be any additional tests other than those recommended for the safe delivery of~     PrEP. These include tests for sexually transmitted infections (STIs) and HIV as well as urine~     and blood tests to monitor kidney function. Information about attendances and test results~     will be anonymously collected through the existing data reporting system that sexual health~     clinics currently use to report to Public Health England.~   "
23929|NCT03253744|"~     Background:~      Prostate cancer is the second leading cause of cancer death in U.S. men. Radiation is an~     effective treatment for most patients with localized prostate cancer, but sometimes the tumor~     returns. Researchers want to see if a highly focused type of radiation can help. It is given~     in only 5 treatments. It is called stereotactic body radiation therapy (SBRT).~      Objective:~      To study the maximum tolerated dose and side effects of stereotactic body radiation therapy~     in people with a local recurrence of prostate cancer after radiation.~      Eligibility:~      Men at least 18 years old who have recurrent prostate cancer after radiation therapy and no~     evidence of distant metastatic disease~      Design:~      Participants will be screened with blood tests, physical exam, and medical history. They may~     also have:~      Magnetic resonance imaging (MRI) scan of the prostate..~      PET/CT scan. Participants will get an injection of 18F-DCFPyL for the PET scan. They will lie~     very still on their back on the scanner table.~      Small samples of prostate tumor tissue will be taken by a needle through the skin or rectum~     to see if the cancer is in the prostate. Small metal seeds will be placed into the prostate~     at the same time to help guide the radiation.~      About 2 weeks later, participants will have a radiation treatment planning CT scan.~      Participants will answer questions about their urine function, bowel function, erectile~     function, and mood.~      Participants will receive SBRT. They will have 5 radiation treatments over 2 weeks.~      Participants will have follow-up visits. They will have a physical exam, blood tests, and~     questionnaires.~      Six months after ending SBRT, the 18F-DCFPyL PET/CT will be repeated....~   "
23930|NCT03253731|"~     Background:~      The two hemispheres of the brain are connected. Changes in one hemisphere affect the other~     through this connection. Research has shown that training new skills in one hand improves the~     same skills for the other hand. Researchers want to learn more about how the brain works to~     transfer the skills to the other hand.~      Objective:~      To learn how changes on one side of the brain affect the other side. To study the activity of~     the left and right sides of the brain in healthy adults.~      Eligibility:~      Healthy volunteers ages 18-55 years old who are right-handed.~      Design:~      Participants will be screened with a medical history and physical exam. They will complete a~     questionnaire about their handedness. This may be done on paper or on a computer.~     Participants may have urine pregnancy tests.~      Participants will have 2 study visits.~      Participants will have a structural magnetic resonance imaging (MRI) scan. MRI uses a strong~     magnetic field and radio waves to take pictures of the brain. The scanner is a metal cylinder~     in a strong magnetic field. Participants will lie on a table that slides in and out of the~     cylinder.~      Participants will have transcranial magnetic stimulation (TMS). Two wire coils will be placed~     on the scalp. A brief electrical current passes through the coil and creates a magnetic pulse~     that affects brain activity. Participants may be asked to tense certain muscles or do simple~     tasks during TMS.~      Participants will have electromyography. Small sticky pad electrodes will be attached to the~     skin on the hands. Muscle activity will be recorded during the TMS procedure.~   "
23931|NCT03253718|"~     Background:~      The Human Motor Control Section does tests for people with movement disorders. In order to be~     sure when a test is normal or abnormal, normal values must be determined in a large group of~     healthy volunteers (HVs). Therefore, the researchers want to study the techniques in HVs.~     They will use the results as the standard of comparison in future clinical studies.~      Objective:~      To get enough normal results in movement tests to use in clinical studies.~      Eligibility:~      Healthy adults ages 18 68~      Design:~      Participants will be screened with medical history and physical and neurological exams.~      Participants will have 1 or 2 visits. They may have:~      Small sticky electrodes attached to the skin on the hands/arms and neck. These will measure~     muscle activity.~      Tiny shocks given to a finger. Participants will be asked if they felt 1 or 2 shocks. This~     will be done to each hand over about 30 minutes total.~      A questionnaire about anxiety.~      Acoustic startle reflex test. Small electrodes will be stuck to the eye, hand, and leg.~     Sensors will be stuck to the palms. Small metal electrodes on the chest and inner arm will~     measure heart rate. Participants will wear headphones. Once everything is in place,~     participants will hear a low sound for about 10 minutes. They will hear a short louder sound~     every 45 60 seconds....~   "
23941|NCT03253588|"~     Traditionally, salpingectomy has been the standard procedure for managing ectopic pregnancy.~     We would like to evaluate the safety and efficacy of laparoscopic tubal preservation surgery~     in treating ectopic pregnancies (salpingostomy or salpingotomy) while preserving the~     fertility outcome of the patients, as well as to identify the factors predicting the presence~     of persistent ectopic pregnancy after the surgery.~   "
24011|NCT03252678|"~     This study verifies efficacy of Self-education program for advanced care planning. Half of~     participants will receive a book and videos about advanced care planning while the other half~     will receive a book and videos about pain control for cancer patients.~   "
24032|NCT03252405|"~     To compare the effect of two different induction method; mask ventilation and intravenous~     cannulation on emergence agitation on pediatric adenotonsillectomy~   "
23933|NCT03253692|"~     Background:~      CCTA is a common way to evaluate coronary artery disease. It stands for coronary computed~     tomography angiography. It uses scanning to look at the arteries that supply blood to the~     heart. It is noninvasive, widely available, and generally accurate. But it does expose people~     to radiation. Exposure to high amounts of radiation can increase a person s risk of getting~     cancer. Researchers want to learn more about the relationship between CCTA and radiation~     exposure.~      Objective:~      To see how much radiation is used to take pictures of the heart and how measures to reduce~     radiation are used around the world.~      Eligibility:~      People ages 18 years and older who need a computed tomography (CT) scan of the heart~      Design:~      Participants will be screened with a review of their medical records.~      Participants may have a pregnancy test.~      Participants will have the scheduled scan. Small, sticky discs will be placed on the chest. A~     small tube will be placed into a vein in the arm. A contrast material (dye) will be given~     through it. Participants will lie on the CT scanning table.~      A CCTA scan usually takes about 15 minutes if the heart rate is slow and steady.~   "
23934|NCT03253679|"~     This phase II trial studies how well WEE1 inhibitor AZD1775 works in treating patients with~     solid tumors with CCNE1 amplification that have spread to other places in the body and do not~     respond to treatment. WEE1 inhibitor AZD1775 may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth.~   "
23935|NCT03253666|"~     To determine the relationships of dietary factors with the subsequent risk of dermatological~     diseases (such as skin cancers and inflammatory or autoimmune dermatoses) in a cohort of~     female registered nurses and male health professionals.~   "
23936|NCT03253653|"~     Waterpipe smoking is a tobacco use method in which smoke passes through a partially-filled~     water jar. Burning charcoal heats the waterpipe tobacco which produces the smoke that the~     user inhales. Waterpipe smoking was associated with increased risk for coronary heart and~     pulmonary diseases. This Waterpipe Study will inform the FDA on regulating waterpipe tobacco~     products and reduce the harm of it use. This study will be conducted at homes of hookah~     smokers, in natural settings, aimed to determine the effects of waterpipe smoking practices~     on physiological injury markers and biomarkers of toxicity of waterpipe tobacco smoking. The~     investigators will employ a repeated measures design. The investigators will recruit a sample~     of 50 adult male and female exclusive waterpipe smokers and a control sample of 25 male and~     female non-smokers via intercept interviews from San Diego County, California communities.~     Waterpipe smokers will smoke one waterpipe tobacco head (10g) of Starbuzz during 3 separate~     sessions with a 7-day washout period before each session, as follows: Session 1, Smoking~     waterpipe tobacco using 1 quick-light charcoal and room temperature water in the waterpipe~     jar, Session 2, Smoking waterpipe tobacco using 1 quick-light charcoal and adding ice cubes~     to the water in the waterpipe jar, and Session 3, Smoking waterpipe tobacco without charcoal~     using a charcoal-free electrically heated waterpipe head to heat the tobacco, and room~     temperature water in the waterpipe jar. The following data will be collected: a) Tobacco Use~     History, b) 4-week Tobacco Exposure Diary, c) Waterpipe Use Session Form, d) Carbon monoxide~     (CO) exposure: Micro+ Smokerlyzer® CO monitor will be used for exhaled CO pre and 2 minutes~     post each smoking session, e) Pulmonary function testing and measuring blood pressure, heart~     rate and respiratory rate, and f) 6 first morning urine samples: pre and post the 3 sessions~     to measure urinary cotinine, a metabolite of nicotine, 4-(methylnitrosamino)-1-~     (3-pyridyl)-1-butanol (NNAL) and NNAL-glucuronides (total NNAL), metabolites of the lung~     carcinogen 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), 1-hydroxypyrene (1-HOP), a~     metabolite of the genotoxic carcinogen pyrene, and S-phenylmercapturic acid (SPMA), a~     metabolite of the human hematotoxicant and leukemogen benzene. The investigators will explore~     exposure levels to furan, a liver toxicant and carcinogen, among waterpipe smokers via~     measuring its urinary metabolite Furan-BDA-NAL.~   "
23937|NCT03253640|"~     This study will investigate the cost and impact of Healthcare Associated Infection (HAI) to~     patients, the health service and the wider community.~      This is in order to develop a model to allow policy makers to compare the cost effectiveness~     of Infection Prevention and Control measures in NHSScotland. The model will support policy~     makers and clinical teams in building a patient centred, safe, effective and efficient~     service.~   "
23938|NCT03253627|"~     This study will use non-invasive neuroimaging (i.e., MRI) to examine whether~     Mindfulness-Based Stress Reduction (MBSR) improves neural markers of cognitive function for~     postmenopausal women taking aromatase inhibitor (AI) therapy for breast cancer. The pilot~     randomized controlled trial will obtain preliminary efficacy of MBSR versus Health~     Enhancement Program (HEP) active control to improve neural markers of cognitive function. The~     final sample will include 32 postmenopausal women with breast cancer. MBSR and HEP groups~     will meet for a matched schedule of 8 weekly 2.5-hour sessions and a one-day weekend retreat.~     Specimen and data collection will be done at three time points: pre-randomization (i.e.,~     within three weeks before beginning the intervention), within three weeks after completion of~     the intervention, and approximately three months (+/- three weeks) post intervention. Change~     scores for neuroimaging parameter estimates will be correlated with change scores for~     measures of cognitive function and affect. Differential expression of genes will be~     correlated with neuroimaging parameter estimates.~   "
23939|NCT03253614|"~     Gentamicin, in combination with a beta-lactam antibiotic, is commonly used for treatment of~     neonatal sepsis. Neonates have a high volume of distribution. It is a paradox that most~     neonatal dosing schedules still recommend lower gentamicin doses (4-5 mg/kg) than in older~     children (≥ 7 mg/kg). In the neonatal unit in Tromsø a simplified gentamicin high-dose (6~     mg/kg) regimen has been in use since 2004.~      The investigators have previously shown that this regimen was associated with low number of~     elevated trough levels, low numbers of prescription errors and no evidence for ototoxicity in~     the immediate neonatal period. However, the long-term safety of gentamicin therapy in~     neonates is not well studied when it comes to ototoxicity and possible nephrotoxicity.~      The objective of the current study is therefore to perform a detailed hearing evaluation,~     including an extended high-frequency (EHF; 9-16 kHz) audiometry, in a follow-up study of~     children (participants) aged 6-15 years who were exposed to a high-dose gentamicin regimen in~     the neonatal period. Moreover, we will investigate blood pressure and urine biomarkers to~     assess renal tubular function. The aim is to include 250 children exposed to gentamicin in~     the neonatal period and a control group of 25 healthy children.~      EHF audiometry is a more sensitive method for detecting ototoxic damage and provides evidence~     of ototoxicity before any hearing loss is detected by conventional systems. This is the~     background for choice of method.~      The primary outcome is the difference in average hearing threshold in the EHF range between~     the control group and the exposed group.~      Secondary outcomes are i) difference in average hearing threshold in the EHF range between~     the children with gentamicin trough levels > 1.0 mg/L versus those who had lower trough~     levels, ii) markers of renal tubular function (kidney injury molecule 1) and iii) blood~     pressure.~   "
23940|NCT03253601|"~     Adherence to rehabilitation interventions is associated with functional outcomes (e.g.~     independence in daily activities, return of motor function) after stroke. Low adherence to~     rehabilitation home programs is common after stroke. Interventions delivered via mobile~     health applications demonstrated positive effects on adherence to health behaviors (e.g.~     medication routines, smoking cessation). The investigators developed the iADAPTS mobile~     application to support adherence to Strategy Training. Strategy Training is an iterative~     rehabilitation intervention the promotes goal setting, planning, and self-monitoring after~     stroke. This study examines the effects of the iADAPTS mobile health application relative to~     a workbook on adherence to Strategy Training after stroke.~   "
24012|NCT03252665|"~     The study intends to evaluate the efficacy of different medicine delivering by targed~     perfusion catheter incoronary administration on epicardial, myocardial perfusion and clinical~     outcomes in STEMI patients undergoing primary PCI.~   "
23942|NCT03253575|"~     The purpose of this study is to test the CANscript™ sensitivity assay, which is a new and~     different assay developed to test the sensitivity of different cancer types to physician~     selected therapies (both drugs and/or drug combinations) indicated for the stage and type of~     cancer for treatment. CANscript™ tests how a patients specific tumor reacts to the therapies~     being considered by the treating physician. CANscript™ test results have been shown to~     closely correspond with actual clinical results, providing physicians with information that~     may help him/her develop a more personalized cancer treatment and care plan based on the~     patients specific condition. The researchers want to see if CANscript™ test results are~     helpful in selecting the treatments prescribed and provided. There will be about 800 people~     taking part in this study, across 5 different tumor types. The study is designed to assess~     the decision impact of the CANscript™ test results in informing physicians in therapy~     selection.~   "
23943|NCT03253562|"~     This is a controlled study to measure the efficacy of using metformin or vildagliptin for~     type 2 diabetic patients who suffers from hypertension to reduce cardiovascular risk~     resulting from both diabetes and hypertension using different parameters measuring~   "
23944|NCT03253549|"~     The SMArTVIEW program evaluates the use of remote, automated monitoring in hospital and at~     home, on patients undergoing cardiac and major vascular surgery, to determine the effect on~     the 45-day risk of hospital readmission and emergency department visits. Half of participants~     will receive the SMArTVIEW intervention of increased monitoring, while the other half will~     receive standard care after surgery.~   "
23945|NCT03253536|"~     Prospective single arm, single center observational study to evaluate Quality of Life (Qol)~     after stereotactic body radiotherapy for patients with hepatocellular cancer. Patients will~     receive work-up, treatment and follow-up exclusively as routinely done except additional~     quality of life measurements. Qol will be measured by standardized and validated EORTC~     questionaires at different time points during routine follow-up.~   "
23946|NCT03253523|"~     Occipital neuralgia and subsequent headaches are associated with significant morbidity and~     impact quality of life and ability to work. Treatment is primarily medical and consists of~     non-steroidal anti-inflammatory medications and medications to treat neuropathic pain. Many~     patient exhaust medical management options and suffer from persistent symptoms.~      Surgical management of chronic headaches including occipital neuralgia is emerging as a tool~     to relieve pain and the burden of morbidity associated with this condition. Dr. Bahman~     Guyuron has been reporting positive results in the literature for the past 20 years. In a~     systematic review of 14 papers it has been demonstrated that peripheral nerve surgery for~     migraines is effective and leads to an improvement of symptoms for 86% of patients.~     Complication rates were low across all studies included. Additionally, Dr Ivica Ducic has~     reported success specifically treating occipital neuralgia headaches, with significant~     improvements in subjective pain outcomes post-operatively. The mechanism behind this is~     thought to be similar to carpal tunnel syndrome, whereby peripheral nerve compression causes~     nerve irritation and pain. The ensuing inflammatory response to tissue injury can cause~     sensitization of nociceptors, resulting in hyperalgesia or allodynia. Surgical release of~     tight surrounding soft tissues results in nerve decompression and relief of symptoms.~      Although there are multiple case series and empiric evidence supporting the safety and~     efficacy of occipital migraine surgery, there are no randomized controlled studies comparing~     surgical intervention with continued medical management.~      As part of the present study, the investigators intend to randomize patients who have~     exhausted maximal medical treatment of post-traumatic occipital headaches to either a~     surgical management group or a continued medical management group. Surgical intervention will~     consist of neurolysis, or release, of the occipital nerves.~   "
23947|NCT03253510|"~     Randomized clinical trial to compare between biting force of mandibular complete denture~     constructed from two different materials; metal reinforced polyamide and conventional~     PMMA,The null hypothesis of the study that there will not be a difference between biting~     force of the complete denture constructed from metal reinforced polyamide and PMMA~   "
23948|NCT03253497|"~     The use of laryngeal mask (LMA) for the purpose of providing airway safety of patients is a~     common method in general anesthesia practice. This practice does not require laryngoscopy and~     there is no laryngeal and tracheal stimulation until endotracheal intubation, so an increased~     hemodynamic response is not expected in the patient. LMA is an airway control device~     consisting of a silicon mask commonly used in cases where endotracheal intubation (ETE) is~     not required and a silicone tubing connected by 30 degrees. The glottic settles around the~     entrance. There is no obligation for muscle relaxation as LMA is intubated. However, if a~     muscle relaxant agent is not used, pharyngolaryngeal side effects such as patient wounds,~     hiccups, coughs, involuntary muscle movement, hypoxia, laryngospasm can be seen when LMA is~     inserted. In these patients complications such as throat burning, sore throat, ear pain,~     voice anxiety, swallowing difficulties are seen depending on the difficulty of LMA placement~     in the postoperative period.~      Benzidamine is an anti-inflammatory analgesic agent that is not related to the steroid group~     as the structure. Benzidamine is different from other non-steroidal anti-inflammatory agents~     in terms of base formation. Benzidamine has local anesthetic effect in concentrations used in~     topical treatment. Chlorhexidine grams (+) gram (-) bacteria are most effective in~     microorganisms such as yeast and some fungi and viruses. Chlorhexidine delays bacterial~     spread with delayed surface effect. It is absorptive from the microbial cell walls and causes~     membrane leakage.~      In this study, investigators aimed to reveal the effects of topical chlorhexidine and~     benzidamine containing spray (chlorobenzene 30 Ml Spray) used before LMA placement on~     hemodynamic response with postoperative throat and ear pain, swallowing difficulty, voice~     anxiety and soft LMA removal.~   "
23949|NCT03253484|"~     The primary objective of this study is to explore the potential clinical effect of targeting~     surgical wounds in all three wound healing phases by non ablative fractional laser (NAFL) to~     reduce scar formation in a randomized controlled trial. Thus, NAFL will be applied during 1)~     inflammation phase (0-3 days) as represented by NAFL-treatment adjacent to surgical wounding,~     2) proliferation phase (4-21 days) by NAFL-treatment immediately after suture removal and 3)~     remodeling phase (21 days-1 year) by NAFL-treatment six weeks after surgery.~   "
23950|NCT03253471|"~     This randomized, double-blind, placebo-controlled, 3-part study will assess the safety,~     tolerability, pharmacokinetics (PK), and antiviral activity (Part 3 only) of orally~     administered AL-611 in healthy volunteers (HV; Parts 1-2) and subjects with CHC (Part 3).~      Part 1: HV will receive 1 of 5 single ascending doses (SAD) of AL-611 Part 2: Eight HV from~     Cohort 3 in Part 1 are planned to receive a second single dose of AL-611 or placebo (as per~     their randomized assignment in Part 1) in a fed state after a washout period Part 3: Subjects~     with CHC infection will receive 1 of 3 planned multiple ascending doses (MAD)~   "
23951|NCT03253458|"~     The current limitations in prostate cancer diagnostics lead to over- and undertreatment for a~     significant fraction of patients. Confocal Laser Endomicroscopy (CLE) and Optical Coherence~     Tomography (OCT) are focal imaging modalities with potential for in-vivo prostate imaging.~     The investigators anticipate that integrating focal imaging with MRI/TRUS fusion will further~     improve prostate cancer detection and provides a real-time histopathological threedimensional~     representation of the tumor lesions.~      This is an investigator-initiated, prospective in-vivo safety and feasibility study with~     transperineal template mapping biopsies (TTMB) and two focal imaging methods, CLE and OCT, in~     prostate tissue.~   "
23952|NCT03253445|"~     The purpose of this study is to evaluate the efficacy of using Acceptance and commitment~     therapy for smoking cessation for schizophrenic patients.~   "
23953|NCT03253432|"~     The purpose of this study is to validate the use of the FH Foundation FIND FH® Algorithm as a~     clinical decision support tool. FIND FH (Flag/Identify/Network/Engage) is a national~     initiative that utilizes machine learning and data mining techniques to identify individuals~     whose profiles are consistent with FH patients. The algorithm will be tested in adults with~     at least one cardiovascular comorbidity. Study subjects will be asked to provide either a~     saliva, buccal or venous blood sample for DNA and biomarker analysis~   "
23954|NCT03253419|"~     The purpose of this research study is to examine home safety and fall risk for patients who~     have undergone hip replacement surgery. The investigators want to know whether evaluating~     home safety impacts perceived and real risk of falls at home. The study will utilize a fall~     risk assessment which is a questionnaire that focuses on perceived and real risk of falls at~     home, as well as a home safety assessment application, the Home for Life App. The participant~     will be asked about the home environment, including areas of the home such as the entrance,~     bedroom, and bathroom, and modification recommendations will be made to potentially increase~     safety.~   "
23955|NCT03253406|"~     The purpose of this pilot randomized trial is to determine (1) the effectiveness of the Polar~     M400, used in combination with a twice-weekly Facebook-delivered Social Cognitive~     Theory-based health intervention, in the promotion of more healthful physical activity and~     nutritious eating behaviors over 12 weeks in college students versus a comparison group; and~     (2) the validity and reliability of the Polar M400 in the assessment of free-living (i.e.,~     non-laboratory based) physical activity (in this case, steps per day and daily durations of~     moderate and vigorous physical activity) and energy expenditure.~   "
23956|NCT03253393|"~     This study is a randomized, contralateral, investigator-masked non-dispensing study, to~     investigate the microbial contamination rates on the back surface of two types of soft~     contact lenses (hydrogel and silicone hydrogel) extracted from Smart Touch Technology blister~     packs versus conventional lens packaging after short-term placement on the eye, and to~     compare the microbial contamination rates of the worn contact lenses to those on the~     participants' hands/fingers used to conduct lens insertion.~   "
23957|NCT03253380|"~     this study aim to compare the effect of early rehabilitation program on mechanical ventilated~     COPD patient in Respiratory ICU to those using current standard care as regarding :~        -  morbidity and thirty day mortality~        -  diaphragm function and weaning outcomes.~        -  disease exacerbation~        -  Duration spent on ventilator.~        -  Length of ICU stay~   "
23958|NCT03253367|"~     Clozapine (CLZ) is generally prescribed if at least two trials of antipsychotic agents have~     not led to satisfactory clinical improvement, thereby implying that patients on CLZ generally~     suffer from more severe and/or persistent symptoms than patients suffering from schizophrenia~     spectrum disorders (SCZ) on other antipsychotic agents. Unraveling the (functional) genetic~     variation underlying this severe SCZ phenotype therefore has the potential to deepen the~     understanding of the biological underpinnings of SCZ beyond the boundaries of DSM-based~     consensus criteria. Such knowledge in turn has the potential to shape future~     pharmacotherapeutic research. It is hypothesized that targeting this phenotype in genome-wide~     association studies and next-generation sequencing studies will signal genetic risk loci~     implicated in this severe SCZ phenotype. In the future, this may lead to early detection of~     severe SCZ, which in turn will enable tailoring of pharmacotherapeutic strategies to such SCZ~     subtypes. The results of this genetic part of the study will be combined with the results~     from our other research protocol 'Phenomics and genomic of clozapine pharmacotherapy - New~     Users'.The overarching goal of both projects is to create a prediction model for clozapine~     outcome (response (and side effects). This model includes genetic, epigenetic and clinical~     data.~   "
23959|NCT03253354|"~     This study will explore the effects of 3 different neurostimulation methods on swallowing~     function in patients with dysphagia secondary to Parkinson's Disease~   "
23960|NCT03253341|"~     The purpose of this study is to test the efficacy of delivering an exercise and healthy~     lifestyle program, Smart Aging, to older adults.~   "
23961|NCT03253328|"~     In this pilot clinical study the investigators propose to conduct a prospective, randomized,~     double-blinded, placebo-controlled clinical trial for 30 days for participants with critical~     limb ischemia (CLI) who undergo a major (above-knee or below-knee) lower extremity~     amputation. By exploring the primary endpoints we aim to determine whether NAC can affect~     amputation stump perfusion and healing. Based on preclinical data, the investigators~     hypothesize that NAC will augment both amputation stump perfusion as well as healing. The~     investigators will utilize the data from this trial to determine the true effect size that is~     necessary for a larger clinical trial to determine the clinical efficacy of NAC is healing~     surgical sites such as major lower extremity amputation stumps.~   "
23962|NCT03253315|"~     The pericardium is a double-walled sac containing the heart and the roots of the great~     vessels. The pericardial sac has two layers, a serous visceral l layer (also known as~     epicardium when it comes into contact with the myocardium) and a fibrous parietal layer. It~     encloses the pericardial cavity, which contains pericardial fluid. The pericardium fixes the~     heart to the mediastinum, gives protection against infection and provides lubrication for the~     heart. Pericardial diseases may be either isolated disease or part of a systemic disease~     Diseases of the pericardium present clinically in one of several ways~        -  Acute and recurrent pericarditis~        -  Pericardial effusion without major hemodynamic compromise~        -  Cardiac tamponade with cardiac compromise~        -  Constrictive pericarditis~   "
23963|NCT03253302|"~     At present, surgical resection is still the main treatment for the potential cure of rectal~     cancer. Total mesorectal excision (TME) is the gold standard. The traditional laparoscopic or~     open surgery for some special patients is really difficult, especially for male, prostate~     hypertrophy, obesity, low tumor and pelvic stenosis patients to expose the gap around the~     mesorectum and separate to the pelvic floor. While transanal total mesorectal excision~     (TaTME) approach could be more directly separate the low mesorectum and relatively simple to~     complete distal rectal transection, which would bring some considerable advantages. Although~     active learning from abroad, laparoscopic assisted TaTME surgery is now in its infancy in~     China. It is urgent for clinical studies to obtain the results in China. This multicenter,~     observational study will help to encourage research in this field and to obtain data on the~     safety and efficacy of this procedure in Chinese patients with rectal cancer.~   "
23964|NCT03253289|"~     Meclizine hydrochloride is an antihistamine widely used for treatment of vertigo and motion~     sickness. In HCC it has been used for anti-emetic effects, but it is used here as a CAR~     (constitutive androstane receptor) inverse agonist.~      The hypothesis of this study is that meclizine, a CAR inverse agonist, will have a beneficial~     therapeutic effect in patients with hepatocellular carcinoma who are candidates for surgical~     resection, ablation or TACE (trans-arterial chemoembolization) by blocking tumorigenesis and~     inducing apoptosis.~   "
23965|NCT03253276|"~     This is an investigator-initiated, double-blind crossover study on the mechanism of OCA~     treatment of patients with PBC.~      Hypothesis and significance~      The investigators will test the hypothesis that OCA administration to patients with PBC~     increases hepatobiliary secretion of cholylsarcosine assessed by PET/CT using 11C-labeled~     cholylsarcosine (11C-CSar) as tracer.~      The results of this research project will elucidate the mechanism of the effect of using OCA~     therapeutically in patients with PBC.~   "
23966|NCT03253263|"~     The purpose of this study is to determine if an investigational drug can reduce respiratory~     complications in extremely premature babies through 12 months corrected age (CA), as compared~     to extremely premature babies receiving standard neonatal care alone~   "
23967|NCT03253250|"~     The current study is a prospective, randomized, open, multi-center investigation. The aim of~     current study is to investigate whether the Recurrence-free Survival Rate (RFS）of the~     hepatitis B related -hepatocellular carcinoma subjects who have been treated by resection can~     be improved by peginterferon alfa-2a~   "
23968|NCT03253237|"~     Introduction and objective: The key to optimal diabetes management is tight glucose control.~     Hemoglobin A1c is the gold standard to assess glycemic control but in cases of unrecognized~     hypoglycemia, confusing nighttime events or in cases of large variations in blood glucose, a~     haemoglobin A1c can not detect specific movement of blood glucose. Continuous glucose~     monitoring (CGM) provides informations of glucose levels in a real-time format and may be~     helpful for making the personalized therapy decisions desired in the era of precision~     medicine. Our aim is to analyse the benefit of tracking patterns of glucose values by using~     continuous glucose monitoring (CGM) in patients with T2DM in family medicine office.~   "
23969|NCT03253224|"~     With ongoing advancements in healthcare leading to prolonged life expectancy, orthopedic~     surgeries are increasingly performed in elderly patients. Total knee arthroplasty, in~     particular, has been increasing with the growing demand for improved mobility and quality of~     life. Total knee arthroplasty is performed on patients with advanced and painful~     osteoarthritis of the knees, but it can result in moderate to severe postoperative pain~     during the recovery period.~      To relieve anxiety or stress during surgery under regional anesthesia, sedation can be~     provided. Dexmedetomidine is a sedative-analgesic agent acting as α2-adrenergic receptor~     agonist, and its analgesic effect has been well established in various procedures or~     surgeries.~      Magnesium has been reported to produce important analgesic effects including the suppression~     of neuropathic pain, potentiation of morphine analgesia, and attenuation of morphine~     tolerance. Although the exact mechanism is not yet fully understood, the analgesic properties~     of magnesium are believed to stem from regulation of calcium influx into the cell and~     antagonism of N-methyl-D-aspartate (NMDA) receptors in the central nervous system. In this~     study, investigators will evaluate the reducing effect of magnesium on the post-total knee~     arthroplasty pain in patients sedated with dexmedetomidine under spinal anesthesia.~   "
23970|NCT03253211|"~     This project will improve the efficiency and quality of healthcare for persons with sickle~     cell disease, an under-served and at risk population by implementing a co-management model of~     care. Many patients with sickle cell disease (SCD) receive care primarily from specialty~     physicians and emergency departments (ED), thus resulting in a lack of primary care and a~     high number of ED visits and hospitalizations. The goal is to improve PCP and SCD specialist~     co-management. The overall purpose of this dissemination project is to evaluate utilization~     data, as well as patient and provider reported outcomes associated with the dissemination of~     a toolbox of decision support tools to PCP's and ED providers across NC and SC.~   "
23971|NCT03253198|"~     This study is a non-blinded randomized controlled trial comparing the use of a preoperative~     mini block plus postoperative local infiltration of Exparel (liposomal form of bupivacaine)~     versus a partial single shot nerve block in subjects undergoing primary reverse or total~     shoulder arthroplasty to see which is more effective in controlling surgery related pain. To~     do so, we will utilize the Visual Analog Scale (VAS) to measure pain intensity. Opioid~     consumption will be recorded on a Pain Monitoring Sheet.~   "
23972|NCT03253185|"~     This is a multicenter, open-label, Phase 1 study in participants with colorectal cancer (CRC)~     or gastric cancer to study the safety and tolerability of SC-007 and consists of Part A (dose~     regimen finding) in participants with CRC followed by Part A in participants with gastric~     cancer. Part B (dose expansion) will enroll participants into separate disease specific~     cohorts of CRC or gastric cancer.~   "
23973|NCT03253172|"~     The current high-sodium, low-potassium diet contributes to the high prevalence of high blood~     pressure (hypertension). Indeed, the anti-hypertensive effects of potassium supplementation~     are well-established. Hypertension is even more prevalent and resistant in patients with~     chronic kidney disease (CKD) and contributes to further decline in kidney function. Four~     recent epidemiological studies (published 2014 - 2016) showed that higher dietary potassium~     intake was associated with better renal outcomes. All studies recommended an intervention~     study with potassium supplementation in patients with CKD, but this has not been performed.~     The aim of this study is to study the renoprotective effect of potassium supplementation in~     patients with CKD (stage 3b or 4, i.e. estimated glomerular filtration rate [eGFR] 15 - 45~     ml/min/1.73 m2).~   "
23974|NCT03253159|"~     Evaluate the impact of the support in reducing postoperative adverse events in particular on~     the pain but also on anxiety, comfort, nausea, vomiting, and fatigue.~   "
23984|NCT03253029|"~     Investigate whether supplementation with branched-chain amino acids (BCAAs) has a positive~     effect on cancer cachexia, as measured by the maintenance or increase in weight and lean body~     mass (LBM) based on body weight in kilograms (kg) and bioelectrical impedance assessment~     (BIA).~   "
23985|NCT03253016|"~     A comparative evaluation to evaluate the correlation between cervical cerclage or vaginal~     progesterone and maternal vaginal microbiome distribution during pregnancy~   "
23975|NCT03253146|"~     Sepsis is the most common cause of death in the clinical critically ill patients. We have~     successfully screened the sepsis biomarkers by clinical proteomics approach and found that~     Vimentin (VIM) played an important role in the occurrence and development of sepsis. However,~     the exact mechanism is remaining unclear. In this study, the relationship between the changes~     of peripheral circulation VIM expression and different stages of sepsis development will be~     further verified in lager clinical trials, as well as the relationship between VIM expression~     and apoptosis of immune cells (e.g lymphocytes) will also be clarified. This may indicate~     that the role of VIM in the cell-mediated immunity apoptosis and inflammation-related~     pathways. Through the implementation of this study, we can clarify the clinical value of VIM~     and the mechanism of VIM-mediated immune cell apoptosis during the sepsis development from~     the molecular level, and determine whether the VIM as a new target for sepsis diagnosis and~     treatment.~   "
23976|NCT03253133|"~     This study determine the maximal tolerate dose~   "
23977|NCT03253120|"~     The Postural Tachycardia-Syndrome (POTS) is a form of autonomic dysregulation, typically~     accompanied by symptoms of orthostatic intolerance (OI). OI is defined by the inability to~     tolerate the upright position and is improved by lying down. POTS is considered a syndrome~     that may include a number of several disorders. Symptoms should be persistent for at least 6~     months to reach a diagnosis. It is characterized by a sustained heart rate (HR) increment of~     30 beats/min or more within 10 min of standing or head-up tilt (HUT) in adults, in the~     absence of orthostatic hypotension and with the presence of symptoms of OI. In children and~     adolescents a diagnosis requests a HR increment of at least 40 beats/min. The increment in HR~     when moving to an upright posture is often a response to a reduction in venous return,~     causing excessive blood pooling in the lower limbs. The symptoms present in POTS vary~     greatly. Typical symptoms are lightheadedness, dizziness, blurred vision, mental clouding~     (brain fog) or cognitive dysfunction. Other symptoms may present as palpitations or chest~     pain. Additional symptoms consist of postural headaches, nausea, sleep disturbances, fatigue~     and gastrointestinal dysfunction. The manifestation of symptoms in POTS varies in severity,~     frequency and combination, resulting in POTS being a very heterogenous and subjective~     disorder. Symptoms can be severe and often make simple daily activities difficult to an~     extent that compromises the patients quality of life. Typically symptoms exacerbate in the~     mornings, after physical activity, after eating and during menstruation.~      This study objective is to examine the occurrence, mechanisms and causes of impaired~     attention in POTS as well as to test the effect of acute water ingestion for attention in~     POTS. The investigators therefore conduct a study including patients with POTS and healthy~     volunteers.~      All participants will receive a dossier of five self-assessment questionnaires after giving~     informed consent. Clinical examination includes 2 HUT-tests while standing for 15 minutes,~     conventional measuring of blood pressure, continuous recording of NIRS signals during~     testing, determination of pupil size, the diameter of the optic nerve and Neuropsychological~     testing (Test of Attentional Performance, mobility version (TAP-M), Go/NoGo Test, Divided~     Attention Test)~   "
23978|NCT03253107|"~     -  discovery and validation of biomarker predicting gastric cancer chemotherapy response~             -  Analysis for expression level of mRNA using Next generation sequencing in gastric~               cancer tissue by chemotherapy response~             -  Analysis for expression level of miRNA using Next generation sequencing in gastric~               cancer tissue and blood by chemotherapy response~             -  Validation of mRNA and miRNA using qRT-PCR in multiple independent cohort~        -  Biological biomarkers-clinical factor combined prediction model of gastric cancer~          chemotherapy response~   "
23979|NCT03253094|"~     This is a multicenter, randomized, double-blind, double-dummy, active-controlled,~     dose-finding study to compare the efficacy, safety and tolerability of oral SCY-078 versus~     oral fluconazole in adult female subjects 18 years and older with moderate to severe Acute~     Vulvovaginal Candidiasis (AVVC). Approximately 180 eligible subjects (30 subjects per~     treatment group) will be enrolled and randomized into the study.~   "
23980|NCT03253081|"~     Parent-mediated interventions often target social communication in young children with ASD,~     although to date studies yield inconsistent effects. One reason for the limited evidence may~     be the considerable heterogeneity in both parent and child characteristics that affect the~     fit of intervention to family and ultimately influence treatment outcome. For parents, these~     factors might include stress associated with the uncertainty of their child's diagnosis,~     caregiver expectations for the intervention itself, and a parent's own style of interaction~     that may be influenced by milder but qualitatively similar ASD characteristics, known as the~     broad autism phenotype (BAP). For children, these factors might include nonverbal DQ,~     language, or sensory impairment. The fit between type of intervention and optimal outcome for~     parent and child is an understudied, yet essential component of early intervention that may~     be susceptible to the influence of heterogeneity in the parent and child. One approach to~     addressing this variability is to implement an adaptive intervention approach that seeks to~     capitalize on heterogeneity among children and parents. Utilizing an adaptive treatment~     design, the current study tests the optimal sequence of intervention delivery and specific~     parent and child characteristics that may moderate treatment success in three 10-week stages~     of intervention. The first phase will randomize parents and children to a parent education~     condition, consisting of a parent support and education group focused on social communication~     development, or to a parent mediated and therapist delivered condition involving coaching of~     the parent with their child in social communication strategies. Phase 2 involves~     re-randomizing parents and children to maintain the same treatment arm, or change to the~     opposite arm to test the optimal sequence of intervention delivery and specific parent and~     child characteristics that may moderate treatment success. In the final phase, dyads are~     randomized to different maintenance arms, each comprised of 5 sessions with one involving~     skype and text contact, the other in -home visits, to explore how best to maintain treatment~     gains once the active intervention phase is complete. This study has the potential to~     dramatically improve child social communication outcomes by individualizing and personalizing~     parent intervention approaches with very young children, a high priority need of the~     Interagency Autism Coordinating Council and NIH.~   "
23981|NCT03253068|"~     To explore the overall response rate (ORR) per RECIST 1.1 as assessed by investigators in~     subjects with refractory small cell lung cancer treated with pembrolizumab (Pembro) plus~     amurubicin (AMR).~   "
23982|NCT03253055|"~     Athletes and active individuals have been identified as an at-risk group for a low vitamin D~     status, specifically those residing in countries of higher latitude (such as the United~     Kingdom). This especially applies to those who train indoors for their sport, this is because~     Vitamin D is primarily produced following skin exposure to ultraviolet B (UVB) exposure.~     Vitamin D is essential for the maintenance of optimal bone and musculoskeletal health. It has~     also been suggested to play a role in the prevention of illness incidence, such as in upper~     respiratory tract infections (URTI). More recent research has indicated that an improved~     Vitamin D status may also play a role in enhancing exercise performance. Therefore, having a~     poor vitamin D status could negatively impact athletic training and competition. The purpose~     of this study is to evaluate the prevalence of vitamin D deficiency in university athletes~     and inactive controls in spring and autumn.~      During this study the subjects will be asked to visit the labs on two occasions, at the~     beginning of the study for baseline measurements, and again on two occasions at the end of~     the study. Participants will have the following outcomes assessed: Sport performance~     (vertical jump height, muscular strength and aerobic fitness), peripheral Quantitative~     Computed Tomography (pQCT) scan of the bone mineral composition of the tibia, total body~     composition via Dual Energy X-ray Absorptiometry (DEXA),total and hip/femoral head bone~     mineral density and content to assess fracture risk via DEXA. Serum 25(OH)D levels (≈15ml of~     whole blood will be collected for these measurements. Dietary intake using self-reported food~     diaries. In addition illness and injury incidence will be recorded daily throughout the study~     in a booklet provided to the participants.Throughout the trial, the participants will be~     contacted via telephone/ email on a monthly basis to discuss any issues and maintain good~     communication.~   "
23983|NCT03253042|"~     The purpose of this study is to analyze the immediate and chronic effects of an exercise~     protocol on the vibration platform on the functional and neuromuscular performance of lower~     limbs, postural control and life quality in healthy elderly.~   "
23987|NCT03252990|"~     This study is designed as a prospective observational feasibility study. The investigators~     will study whether vulnerable plaques on OCT (fibrous cap ≤ 70 μm) show a locally increased~     uptake of 18F-choline on PET-MRI compared to stable plaques and whether the culprit plaque~     shows a locally increased uptake of 18F-choline on PET-MRI compared to non-culprit plaques.~     First, 15 NSTEMI or STEMI patients who underwent urgent percutaneous coronary intervention~     (PCI) of the culprit vessel, who are diagnosed with multivessel coronary disease and are~     currently scheduled for a second PCI at the VieCuri hospital will be included. These patients~     will be subjected to an additional 18F-choline PET-MRI examination at the MUMC+ and an~     additional optical coherence tomography (OCT) examination (during the PCI procedure at the~     Viecuri hospital). OCT will be performed as a reference standard to validate 18F-choline~     PET-MRI for detection of vulnerable plaques in the coronary arteries. In addition, 15 NSTEMI~     patients, who are scheduled for PCI of the culprit lesion at the MUMC+, will be subjected to~     an additional 18F-choline PET-MRI examination at the MUMC+. Hereby, the culprit coronary~     vessel and thereby the culprit plaque can be identified by the location of the myocardial~     infarct, as identified by late enhanced MRI. The investigators will study whether the culprit~     plaque shows an increased 18F-choline uptake on 18F-choline PET-MRI compared to non-culprit~     plaques in the other coronary arteries. All patients will receive standard, guideline-based~     clinical care, while PET-MRI and OCT will be performed as additional measurements. Before the~     start of the study, 5 stable angina pectoris patients that are scheduled for a PCI procedure~     at the MUMC+ will be included at the MUMC+ for a single PET-MRI scan to optimize the~     parameters of the coronary PET-MRI scan.~   "
23988|NCT03252977|"~     Opioids via intravenous patient-controlled analgesia (IV PCA) are widely used for~     postoperative pain control. However, effective pain control with minimized side effects of~     analgesic agents is still challenging. Several studies reported that preoperative pain~     sensitivity measured by quantitative sensory test could predict postoperative pain.~     Therefore, the investigators planned this trial to evaluate the effectiveness of tailored~     patient-controlled analgesia based on preoperative pain sensitivity measured by pressure pain~     threshold in patients undergoing gynecological surgery.~   "
23989|NCT03252964|"~     This study allows Type 2 diabetics to receive feedback from a continuous glucose monitor~     (CGM) as part of an educational program designed to help them better manage their glucose~     levels. Subjects will also wear an activity tracker to monitor their activity and observe its~     effect on their glucose levels. The educational program will involve calls from coaches to~     check subjects' progress and answer questions.~   "
23990|NCT03252951|"~     Anal incontinence is a significant public health problem estimated to affect 7-15% of women~     in the United States. Traditional rehabilitation strategies include biofeedback and Kegel~     exercises for pelvic floor muscle strengthening, but this strategy does not incorporate~     strategies for resistance training that are known to cause muscle strengthening and~     hypertrophy in other muscles in the body. This study aims to investigate whether a novel~     pelvic floor resistance exercise program will increase pelvic floor muscle strength and~     improve anal incontinence and has the potential to impact rehabilitation strategies for the~     millions of women affected anal incontinence.~   "
23991|NCT03252938|"~     This phase I trial aims to investigate a potential enhancement of IMP321 immune-activating~     effects by new routes of administration: direct injection of IMP321 into the tumor tissue;~     intra-peritoneal therapy; combination of chemotherapy with active immunotherapy~     (chemo-immunotherapy)~   "
23992|NCT03252925|"~     HSCT associated thrombotic microangiopathy(TA-TMA) is a heterogeneous, fatal disorder seen~     within 100 days post-transplant and presents with thrombocytopenia, hemolysis, acute renal~     failure, mental status changes and involvement of other organs. N-Acetylcysteine (NAC) is a~     small, simple molecule that began as a generic drug almost 40 years ago. It has since been~     approved by the FDA for many indications. The investigators conducted an prospective clinical~     trial to evaluate the safety and efficiency of NAC in patients with TA-TMA.~   "
23993|NCT03252912|"~     Breast cancer (BC) is the most frequent cause of leptomeningeal metastases (LM) .As for brain~     parenchymal metastases, the incidence of LM seems to be increasing, due to the growing~     incidence of metastatic BC, the improvement of survival and the poor diffusion of therapeutic~     agents into the central nervous system (CNS). Several prognostic factors have been~     identified, including the age at diagnosis, the functional and neurological status, the delay~     between the diagnosis of cancer and that of LM. The survival of patients is poor, less than 6~     months in most published series. Several neuronal biomarkers could also be good candidates,~     such as the neurogranin CSF and/or serum levels or the CNS neurofilaments (NF), that seem to~     be a good reflect of axonal injury and neuronal loss. CNS NF have been investigated in~     several neurological diseases including Alzheimer's disease, Parkinson's disease, amyotrophic~     lateral sclerosis and multiple sclerosis, but not yet in CNS metastases. Indeed, the creation~     of a clinico-biological collection seems to be of high value in order to investigate future~     biomarkers of interest~   "
23994|NCT03252899|"~     A survey was conducted among physiotherapists and occupational therapists working with stroke~     patients. The survey consisted out of 30 questions enquiring personal information and upper~     limb specific topics divided in 3 sections: (1) Passive mobilization, (2) Active exercises~     and (3) Immobilization. The survey took approximately 20 to 30 minutes to complete.~      The survey for stroke survivors was divided in seven sections: (1) Personal information (2)~     Motor recovery of the upper limb and expectations on upper limb recovery; (3) Comfort, pain~     and quality of life (QoL); (4) Immobilization ; (5) Physiotherapy; (6) Occupational therapy;~     (7) Nursing (only for patients less than 6 months after stroke). The length to complete the~     survey was also organized to be achieved in 20 to 30 minutes.~   "
23995|NCT03252886|"~     This is a clinical study based on collected video-clip data of cardiopulmonary resuscitation~     for patients with suspected neck injury in multiple trauma between 2011 and 2015. The study~     aimed to compare all possible factors relating to ETI performance during CPR for truma~     patients between experienced video-laryngoscopy and direct- laryngoscopy users.~   "
23996|NCT03252873|"~     Investigators will compare the factors affecting the adherence to the outpatient pulmonary~     rehabilitation program in COPD patients~   "
23997|NCT03252860|"~     The investigators set out to determine the extent of compliance with the World Health~     Organization Surgical Safety Checklist and the association of this compliance with~     perioperative surgical outcomes in five of Uganda's referral hospitals.~   "
23998|NCT03252847|"~     A clinical trial of AAV2 vector for patients with X-linked retinitis pigmentosa (XLRP)~   "
24013|NCT03252652|"~     the study will be carried out to standardize normal parameters of vascular duplex ultrasound~     of the cranial vessels in the Egyptian population.~   "
24014|NCT03252639|"~     This study will use PBV technique to quantitatively assess the improvement of renal perfusion~     before and after endovascular treatment (EVT) of renal artery stenosis.~   "
24052|NCT03252145|"~     This study will be a 4 to 6 week randomized, controlled, assessor blinded, trial comparing a~     negative pressure massage device (intervention group), to the standard manual lymph drainage~     massage (control group), in breast cancer patients with chronic upper extremity lymphedema.~   "
23999|NCT03252834|"~     This is a prospective, single arm, single center study evaluating the use of a 4-gene panel~     to predict the occurrence of chemotherapy-induced abnormal thermal threshold in endometrial~     and ovarian cancer patients receiving post-operative chemotherapy with~     Carboplatin/Paclitaxel, and stage III colorectal cancer patients receiving adjuvant~     chemotherapy with mFOLFOX6. A total of 100 patients will be enrolled during 2017 July~ 2019~     June. Blood sample will be collected before chemotherapy to analyze the genetic variants of~     TRPV1, TRPM2, TRPA1 and ORAI1. All patients will receive neurologic examination (Quantitative~     Sensory Test, QST) and complete the questionnaires for quality of life (EQ5D & CIPN20). The~     primary endpoint of this study is to test if the genetic variant of TRPV1, TRPM2, TRPA1, and~     ORAI1 is a predictive biomarker for the chemotherapy-induced abnormal thermal sensation in~     cancer patients.~   "
24000|NCT03252821|"~     The aim of this study is to assess the impact of a high-intensity aerobic training and~     resistance training on fatigue in prostate, head and neck and rectum cancer patients~     undergoing radiotherapy.~      A three-arm randomized controlled trial will be conducted. Patients will be randomised into~     either a high-intensity aerobic training group or a resistance training group or a control~     group. Participants in the training groups will exercised for five to eight weeks. Exercise~     sessions will be take place 3 days per week under the supervision of an experienced~     therapist. Subjects will be assessed at baseline and post-intervention. The primary outcome~     will be fatigue measured using the FACIT-fatigue questionnaire. The secondary outcomes will~     be: functional capacity, quality of life, executive functions, sleep disturbances, somnolence~     syndrome, insomnia, depression symptoms.~   "
24001|NCT03252808|"~     The purpose of this study is to determine the recommended dose of TBI-1401(HF10) treatment in~     combination with chemotherapy (Gemcitabine + Nab-paclitaxel or TS-1) in Japanese patients~     with stage III or IV unresectable pancreatic cancer.~   "
24002|NCT03252795|"~     Uterus transplantation: screening, in vitro fertilization [IVF] treatment to be able to~     freeze embryos, uterus transplantation, pregnancy and afterwards removal of the uterus.~   "
24003|NCT03252782|"~     The correction of Class II malocclusion is one of the most common problems facing the~     orthodontist, with an estimated one-third of all orthodontic patients treated for this~     condition. Many strategies are available for Class II treatment on growing patients, and most~     orthodontists tend to choose a treatment protocol based on what part of the craniofacial~     deformity they believe the appliance will affect the most. A number of authors have described~     the dentoalveolar and skeletal changes induced by the Herbst appliance. The dentoalveolar~     effects consist of distalization of the maxillary molars and forward movement of the~     mandibular dentition. The main skeletal change mandibular stimulation is acceleration of a~     patient's inherent mandibular growth rather than increased growth beyond what would occur~     without treatment. Maxillary molar distalization, is one of the Class II treatment.~     Mini-implants have become popular in recent years, and various kinds of mini-implant-borne~     distalization approaches have been described. Because Class II correction appears to be~     achievable with either appliance, a follow-up question is whether there is a difference in~     the esthetic outcomes. However, because of the complexity of the human face and the~     subjectivity of facial beauty, a simple set of measures of lines or angles cannot quantify~     facial beauty. With the advances in 3-dimensional imaging, it is now possible to capture and~     superimpose digital images and measure the changes in the soft tissues from 3-dimensional~     images. Such advances in facial imaging allow a more thorough investigation of changes in 3~     dimensions and prevent the inherent loss of information that results from 2-dimensional~     imaging. Optical scanners with short shutter speeds are convenient for clinicians and~     patients for capturing soft-tissue records. Bearing in mind that the aim of orthodontic~     treatment is to achieve facial harmony along with excellent occlusion, one of the most~     important objectives of an orthodontist should be the improvement of facial appearance.~     Therefore, it is important to gain a better understanding of how or whether orthodontic~     procedures affect the appearance of the soft tissues. Thus, the aim of this clinical trial is~     three dimensional evaluation of soft tissue facial changes on late mixed dentition patients~     following maxillary arch distalization with palatal screws one group and acrylic split herbst~     patients on other group and to compare these changes.~   "
24004|NCT03252769|"~     Cervical cytology screening coverage in Northern Ireland (the proportion of eligible women,~     aged 25-64 years who have had a test result recorded in the previous five years) has~     increased steadily since 2005 to 78% in 2012/2013; almost reaching the 80% coverage target.~     The uptake of cervical screening among women in the 25-29 year age group in Northern Ireland~     however, has remained consistently lower (70-73%) than all other age groups except for the~     60-64 year age group where the coverage rate is similar. The main barriers preventing women~     from attending for cervical screening are: embarrassment; inconvenience; time and discomfort~     associated with obtaining cervical samples. Studies have shown that offering women the~     opportunity to collect a vaginal self-sample to test for HPV (the main risk factor for~     cervical cancer) could increase screening coverage. Non-attenders in the Western and Belfast~     Health and Social Care Trust area, aged 25-29 years, will be identified by GPs. Letters with~     information relating to the study and collection devices will be sent to women giving them~     two options: 1. inviting them to book a normal screening appointment; 2. inviting them to~     collect a self-sample for HPV testing with either a swab or brush collection device.~     Participants for receipt of swab or brush will be randomised. Acceptance to participate in~     the study will be indicated by signed consent. Returned self-collected samples will be HPV~     tested. If a sample is negative, no further investigation is required and the woman will be~     encouraged to accept her next screening invitation. If a sample is positive the woman will be~     encouraged to book a screening appointment. The study will evaluate: impact on screening~     uptake, acceptance of self-sampling for both devices, practicality and cost-effectiveness of~     the intervention.~   "
24005|NCT03252756|"~     The goal of the proposed project is to begin rigorous study of the clinically relevant~     effects of non-psychoactive phytocannabinoid cannabidiol (CBD) in patients with severe~     alcohol use disorder (AUD). This double-blind, randomized proof-of-concept study (n = 40) is~     designed to assess feasibility and contrast effects of extended (8 weeks) treatment with CBD~     to those of placebo in AUD patients. Participants with AUD will be randomized to receive~     either placebo or 600mg CBD/day (PO) for 4 weeks, immediately followed by 1200mg CBD/day (PO)~     for an additional 4 weeks (8 total weeks). These doses were chosen to reproduce serum CBD~     levels reported to reduce alcohol-seeking behavior in animal studies. Measures will include~     circulating levels of CBD, safety measures (THC serum levels, adverse events, cognitive and~     motoric function), and physiological and psychological domains relevant to AUD (including~     self-reported craving, depression, and anxiety, and responses to personalized scripts~     designed to elicit stress- and cue-induced craving and anxiety). Assessments will be~     conducted following 1 day, 1 week, and 4 weeks of treatment with each dose of CBD vs.~     placebo, and 1 and 4 weeks after the cessation of treatment. Drinking outcomes across 8 weeks~     of treatment and 4 weeks of follow-up will also be assessed as an exploratory outcome.~   "
24006|NCT03252743|"~     This open trial aims to evaluate feasibility and preliminary effectiveness of an~     internet-delivered CBT-program for children and adolescents with functional gastrointestinal~     disorders when implemented in regular care.~   "
24015|NCT03252626|"~     Ischemic stroke has a variety of treatments and currently drug therapy is one of the main~     treatments.A number of clinical studies have proved that alprostadil (PGE1) has~     pharmacological effects of significant dilation of blood vessels, inhibition of plate~     aggregation, anti-atherosclerosis and increased cerebral blood flow.Evaluate the 90-days~     efficacy by comparing two groups of patients'(one with alprostadil,another with placebo) mRS.~   "
24016|NCT03252613|"~     This translational study will assess the association between septic cardiomyopathy (measured~     via left ventricular global longitudinal strain) and (a) inflammatory cytokine profiles, and~     (b) the behavior of cardiomyocytes derived from inducible pluripotent stem cells.~   "
24017|NCT03252600|"~     This randomized phase II trial studies how well lenalidomide, dexamethasone, and eotuzumab~     with or without cyclophosphamide work in treating patients with primary amyloidosis that has~     come back after a period of improvement. Drugs used in chemotherapy, such as lenalidomide,~     dexamethasone, and cyclophosphamide, work in different ways to stop the growth of cancer~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Monoclonal antibodies, such as eotuzumab, may interfere with the ability of cancer~     cells to grow and spread. Giving lenalidomide, dexamethasone, and eotuzumab with~     cyclophosphamide may work better in treating patients with primary amyloidosis.~   "
24018|NCT03252587|"~     This study will investigate BMS-986165 to assess its effects in patients with systemic lupus~     erythematosus (SLE).~   "
24019|NCT03252574|"~     The primary objective is to evaluate the physiological impact of AIR+ Smart Masks on~     end-tidal carbon dioxide (ETCO2) of children aged 7 to 14 years of age. The secondary~     outcomes include other physiological parameters such as oxygen saturation (SPO2), heart rate~     (HR) and respiratory rate (RR). In addition, we will assess the general well-being and~     comfort level of the child when wearing the AIR+Smart Mask with and without micro-ventilator.~   "
24020|NCT03252561|"~     Laparoscopic (key-hole) appendicectomy is a minimally invasive procedure when compared to~     open large bowel resection, but is still associated with a significant amount of pain and~     discomfort. Analgesia is commonly provided by a multi-modal technique involving varying~     combinations of paracetamol, Non steroidal anti-inflammatory drugs (NSAIDs), regional~     analgesia and oral or parenteral opioids. Opioids are associated with an increased incidence~     of nausea, vomiting and sedation which can complicate post-operative recovery. Different~     techniques of intraoperative infiltration of local anaesthetic to control postoperative pain~     are also being used. Their perceived benefits are thought to relate to reduced opioid~     consumption and therefore reduced opioid side effects.~      Transversus Abdominis Plane (TAP) block is a technique which numbs the nerves carrying pain~     sensation from the abdominal wall and provides effective and safe analgesia with minimal~     systemic side effects. Their perceived benefits are thought to relate to reduced opioid~     consumption and therefore reduced opioid side effects. The investigators believe ultrasound~     guided TAP blocks will reduce pain and morphine consumption with a resultant improved patient~     satisfaction, a reduction in post-operative nausea and vomiting and earlier hospital~     discharge.~      The key research question the investigators are trying to answer is whether TAP block provide~     better pain relief than local anaesthetic infiltration of the laparoscopic port sites. Both~     techniques are currently being used in the investigator's hospital.~   "
24021|NCT03252548|"~     This study is a prospective cohort study of children diagnosed with primary immunodeficiency~     disease (PID). The aim is to investigate the clinical characteristics and prognosis of PID in~     Chinese children.~   "
24022|NCT03252535|"~     Cellavita HD is a stem-cell therapy for Huntington's Disease. This is a prospective, phase~     II, single-center, randomized (2:2:1), triple-blind, placebo controlled study, with two test~     doses of Cellavita HD product.~   "
24023|NCT03252522|"~     This proposed research will use randomized control trial (RCT) methodology and compare~     micronutrients with placebo in 120 children with ADHD.~   "
24024|NCT03252509|"~     This study intends to evaluate the security and success rate of large bore percutaneous~     radiologic gastrostomy in patients with head and neck tumors, as a outpatient procedure.~   "
24025|NCT03252496|"~     This study will compare between combination of colloids/crystalloids and crystalloids in~     women with preeclampsia undergoing elective cesarean delivery under spinal anesthesia~   "
24026|NCT03252483|"~     This randomized controlled trial was implemented to evaluate the effect of integrating rapid~     Hepatitis C (HCV) testing into a pre-existing screening program for Human Immunodeficiency~     Virus (HIV) on HIV test acceptance and diagnosis of both HCV and HIV. A sample of 478 adults~     in a New York City Emergency Department participated in the study. Participants were~     randomized to receive either an offer of bundled HIV/HCV testing or HIV testing alone. Public~     Health Advocates approached eligible patients in the Emergency Department, performed HIV and~     HCV raid testing, and delivered test results to participants with post-test counseling. The~     primary outcome, HIV test acceptance, was compared between the two groups to evaluate whether~     the addition of an HCV test adversely impacted participants' consent to test for HIV.~     Questionnaires were also distributed to participants to assess HCV knowledge.~   "
24027|NCT03252470|"~     This is a hypothesis generating pilot study to compare the impact of 2D versus 3D~     visualization on surgical performance, as measured by the OR BlackBox platform, during~     laparoscopic bariatric surgery.~   "
24028|NCT03252457|"~     The project was undertaking by Qilu Hospital of Shandong University and other 4 well-known~     hospitals in China. In order to report the efficacy and safety of decitabine combining with~     dexamethasone for the treatment of adults with immune thrombocytopenia (ITP), compared to~     dexamethasone alone .~   "
24029|NCT03252444|"~     The investigators will test whether conscious control with manual guides and video or EMG~     biofeedback will enhance 3-D kinematics of scapula in shoulder dysfunction subjects with~     different type of scapula dyskinesis. The investigators will also examine how correction of~     scapular orientation may affect the activation of associated muscles during various dynamic~     movements in these subjects.~   "
24030|NCT03252431|"~     This is a randomized, multi-center, single dose, open-label and Neulasta controlled phase 3~     study to evaluate the efficacy and safety of F-627 in women with Stage I - III invasive~     breast cancer receiving chemotherapy treatment.~   "
40984|NCT03030274|"~     This study aims to investigate safety and efficacy of the Occlutech® AFR device in patients~     with HFrEF (Heart failure with reduced ejection fraction) and HFpEF (Heart failure with~     preserved ejection fraction)~   "
24033|NCT03252392|"~     Co morbidity rates of hearing loss in children with autism spectrum disorder are high and~     increasing.~      Investigators are aiming to:~        1. evaluate peripheral auditory and brain stem auditory function in children with autism~          spectrum disorder.~        2. compare communication capabilities in autistic children having hearing abnormalities and~          autistic children with normal hearing.~   "
24034|NCT03252379|"~     Roux-en-Y hepaticojejunostomy is the standard procedure used by most hepatobiliary surgeons~     for biliary reconstruction following iatrogenic bile duct injury, benign and malignant CBD~     strictures, choledochal cysts and biliary tract tumors management. The incidence of~     anastomotic stricture following hepaticojejunostomy in experienced centers ranges between~     5%-22%. Hepaticojejunostomy stricture is a serious complication of biliary surgery, if~     untreated, can lead to repeated cholangitis, intrahepatic stones formation, biliary~     cirrhosis, hepatic failure and eventually death.~      Revision of hepaticojejunostomy is a complex procedure, the surgical procedure being made~     difficult by the sequelae of long-standing unrelieved biliary obstruction like portal~     hypertension due to secondary biliary cirrhosis, atrophy of liver lobes and presence of~     cholangiolytic liver abscess.~      Endoscopic management is not only the least invasive but also very effective via either~     balloon dilatation or stenting of the stricture. In patients with Roux-en-Y~     hepaticojejunostomy, the endoscopic access to the anastomosis is hampered by the distance~     traveled by the jejunal loop until reaching the angle of the enteral anastomosis.~      Many modifications of hepaticojejunostomy to provide permanent endoscopic access have been~     described in the literature including duodenal, gastric and subcutaneous access loops.~      Gastric access loop was first described by Sitaram et al. Ten patients had undergone gastric~     access loop. Access loop was entered easily with the gastroscope in five patients in whom it~     was attempted. In a series with 16 cases, Hamad MA and El-Amin H assessed different~     construction of gastric access loop in the form of bilioenterogastrostomy the overall success~     rate of endoscopic access to the HJ through the three types of BEG was 87.5%, while it was~     100% for BEG type III, which is a construction similar to the previous series (BEG) type.~      Subcutaneous loop access was described by Chen et al. and by Huston et al. In Hutson's series~     of 7 patients, recurrent strictures were treated with repeated balloon dilations. The stone~     extractions were all successful. In most series, the subcutaneous loop was used for~     management os HJ stricture and intrahepatic stones by radiologic intervention. Recently the~     subcutaneous loop can be used as an endoscopic biliary access.~   "
24035|NCT03252366|"~     using gel foam [ absorbable gelatin ] in maxillary sinus elevation which act as a space~     maintainer and alternative to bone filler for new bone formation in the maxillary sinus and~     its advantages for patients undergoing maxillary sinus elevation with simultaneous implant~     placement as regards the implant stability and amount of bone height gain compared to~     conventional maxillary sinus elevation by xenograft.~   "
24036|NCT03252353|"~     Octreotide capsule is a novel, orally-administered formulation of the commercially-available~     injectable drug octreotide. In a recent phase 3 trial, oral octreotide capsules demonstrated~     maintenance of biochemical response up to 13 months in the majority of patients with~     acromegaly previously managed with somatostatin analog injections (reference below).~   "
24037|NCT03252340|"~     This study aims to evaluate safety in subjects with over moderately subacute and chronic~     atopic dermatitis after an intravenous injection of ADSTEM Inj. Since this is an~     observational study of patients participated in Phase 1 clinical trials, no drug is~     administered in this study.~   "
24038|NCT03252327|"~     Frequent pain and distress may affect infants' brain and neural development, and highlight~     the need for relieve pain interventions. Peripheral venous puncture procedures are an~     important source of preterm infants' pain and distress. Brain development is mainly created~     by infant sensory experience. It becomes important, therefore, to relieve preterm infants'~     pain and distress using multiple sensory integrations during peripheral venous puncture~     procedures.The proposed 2-year study has specific aim: to compare the effects of different~     combination of sensory integrations on preterm infants' pain and distress before, during, and~     after peripheral venous puncture procedures.~   "
24039|NCT03252314|"~     To determine safety and occlusion rates when second-generation hydrogel coils are used in the~     treatment of ruptured intracranial aneurysms.~   "
24040|NCT03252301|"~     The trial will estimate post-operative pain management in elective surgical patients using~     the PMD-200 device. The device measures physiological parameters by placing a non-invasive~     sensor on a fingertip and displays an objective pain level in a 0-100 scale. The pain level~     will be estimated before surgery (baseline), after surgery and during administration of~     parenteral analgesia. Treatment and analgesia will be given according to clinical~     considerations and standard ward protocols. The device measurements won't influence the~     treatment.~   "
24041|NCT03252288|"~     Vaccination is a cost-effective strategy for conferring immunity against a host of~     preventable diseases, however, rates of timely childhood vaccinations remain inadequate in~     resource-limited settings. We propose to evaluate the feasibility and efficacy of~     mHealth-assisted conditional cash transfers as a means of overcoming individual barriers to~     timely vaccinations. The study will form the basis for a pragmatic randomized controlled~     trial of the efficacy and cost-effectiveness of mHealth reminders and conditional cash~     transfers for improving rates of timely vaccinations among young children.~   "
24042|NCT03252275|"~     The aim of this study is to test an intervention that has potential to improve acute care~     skills and confidence related to safe delivery and newborn care for mid-level health~     providers in Uganda by the development of a 'mobile' simulation package including scale-up~     materials based upon research evidence. In this randomized study investigators will compare~     the impact of a peer learning package on skills, knowledge and team work regarding newborn~     care among health workers in rural south western Uganda.~   "
24043|NCT03252262|"~     The primary purpose of this project was to implement Vitalize 360, a comprehensive assessment~     system and wellness coaching program for vulnerable, low income, community dwelling older~     adults, and to determine if this program is effective in promoting and sustaining~     self-management skills to increase well-being and functional health among this group.~     Designed specifically for community-dwelling older adults, Vitalize 360 provides a unique~     opportunity to guide elders in selecting personal goals that align with their assessment~     results and develop an action plan for goal achievement. This strategy holds potential as an~     effective mechanism to empower elders to implement behaviors that promote healthy aging.~   "
24053|NCT03252132|"~     This is a population-based study of type 2 diabetes patients with and without neuropathy~     recruited from the Danish National Type 2 Diabetes cohort (DD2).~      Diabetic patients with neuropathy may suffer from incapacitating symptoms such as pain,~     muscle weakness and impaired balance. Muscle weakness may cause reduced balance and postural~     instability increasing the risk of frequent falls and thereby increased morbidity and~     mortality. Thus, diabetic neuropathy is associated with significant disabilities having major~     impact on activities of daily living and quality of life.~      The effects of resistance training on neuropathy symptoms, muscle strength and muscle~     structure in patients with and with diabetic neuropathy will be examined.~   "
24044|NCT03252249|"~     Despite substantial evidence supporting the use of dual anti-platelet therapy in patients~     with acute coronary syndrome, there remains major uncertainty regarding the optimal duration~     of therapy. Recent evidence suggests that shorter durations of dual anti-platelet therapy are~     superior because the avoidance of atherothrombotic events is counterbalanced by the greater~     risks of excess major bleeding with apparent increases in all-cause mortality with longer~     durations. The investigators propose a Scotland-wide randomised controlled trial of 19,424~     patients with acute coronary syndrome allocated to differing durations of dual anti-platelet~     therapy. In collaboration with the Farr Institute, the investigators will exploit NHS~     Scotland's unique and innovative electronic health record linkage infrastructure to track~     duration of therapy and clinical outcomes in a real-world, real-time, efficient and highly~     cost-effective trial. This has the potential to define treatment duration, settle a major~     outstanding international controversy, and influence modern cardiology practice across the~     world.~   "
24045|NCT03252236|"~     People with stroke suffer from different impairments, including the ability to dual-tasking,~     increased arterial stiffness, and dysfunction of the autonomic nervous system. The decrement~     in dual-tasking performance has been found among stroke survivors, and the deterioration has~     been related to increased risk of fall in the population. No coherent result has been~     concluded from previous studies investigating the effect of different types of exercise~     training on enhancing dual-tasking performance among healthy older adults and stroke~     survivors.~      Increased arterial stiffness and impaired functioning of the autonomic nervous systems, which~     have been associated with increased cardiovascular risk and mortality, are common in stroke~     survivors. Studies have been suggesting the beneficial effects of aerobic exercise on both~     decreasing arterial stiffness and regulating the autonomic nervous system among healthy older~     people. However, only a few studies concerning such topic have been conducted among stroke~     survivors, yet the results were inconsistent.~      Tai Chi is a Chinese traditional martial art and has been employed as a rehabilitation~     exercise in recent decades. Tai Chi practitioners should perform the physical movement and~     plan the Tai Chi forms simultaneously. The involvement of cognitive functioning gives Tai Chi~     a dual-tasking character. Prior studies demonstrated the beneficial effect of Tai Chi~     training on dual-tasking performance in healthy older adults, but would the effect extend to~     stroke survivors has not yet been studied.~      Also, Tai Chi is considered as a mind-body exercise. It is suggested that one should keep a~     relaxed status of mind and breathe gently and slowly. Moreover, Tai Chi is an exercise with~     moderate intensity. These features have been found to decrease arterial stiffness and benefit~     functioning of the autonomic nervous system. Indeed, studies have been showing Tai Chi~     reduces arterial stiffness and improves regulation of the autonomic nervous system among~     healthy population. Whether such effect can be observed in stroke survivors is still unknown.~      This study aimed at investigating the effects of Tai Chi training on dual-tasking~     performance, arterial stiffness, and autonomic system functioning among stroke survivors.~     Given the special features of Tai Chi and its advantageous effects on the mentioned~     functioning, it is expected that stroke survivors may also benefit from Tai Chi training.~   "
24046|NCT03252223|"~     Women with PCOS suffer from anovulation and, as a result, infertility. Efforts to clinically~     induce ovulation in these women using follicle stimulating hormone (FSH) administered~     subcutaneously seemingly requires prolonged administration compared to that of ovulatory~     women without PCOS. The apparent differing ovarian responsiveness to FSH between PCOS and~     normal women has not been carefully studied. We propose to address this issue by performing a~     dose-response study and examine ovarian follicle (estrogen, E2) responses to FSH administered~     subcutaneously in women with PCOS compared to responses observed in normal women.~   "
24047|NCT03252210|"~     This study evaluates the feasibility，accuracy and safety of Preoperative Stereoscopic~     Localization Versus Methylene Blue Localization in GGO Wedge Resection. In the first~     stage，participants will receive both Preoperative Stereoscopic Localization and Methylene~     Blue Localization .In the second stage,participants only receive Preoperative Stereoscopic~     Localization for Wedge Resection.~   "
24048|NCT03252197|"~     Two-dimensional ultrasound guided approach does not guarantee first attempt success on~     internal jugular vein cannulation. New attachable device recently was developed for accurate~     needle insertion when ultrasound is used. Our randomized parallel simulation study will~     examine whether this device will improve the first attempt success rate when ultrasound~     guided internal jugular vein catheterization of simulated internal jugular vein.~   "
24049|NCT03252184|"~     The endothelial cell layer is responsible for the control of vascular homeostasis, a process~     mediated by vasoconstricting and vasodilatory substances. The principal endothelium-dependent~     vascular dilator is nitric oxide (NO), and the reduction of its synthesis or bioavailability~     is the main cause for the development of endothelial dysfunction. The use of~     photobiostimulation may be beneficial in several clinical situations. At the endothelial~     level, the photostimulatory action on vascular endothelial growth factor, NO secretion,~     number of capillaries and proliferation of endothelial cells is outstanding.The objective of~     this study is to evaluate the effects of photobiostimulation on the arterial endothelial~     function of healthy individuals. The study design will be a cross-over trial and the sample~     will be composed of 12 healthy subjects selected by the eligibility criteria, and randomly~     randomized according to the order of intervention of the groups. The hypothesis is that at~     the end of the irradiation protocol with photobiostimulation an increase in endothelial~     function and blood markers of endothelial function occurs, and no tissue temperature~     variation. The research will be developed in room 709 of the Laboratory of Physiotherapy in~     building II, UFCSPA. Individuals will be randomly assigned to: group 1 (energy dose of 2J),~     group 2 (energy dose of 4J), group 3 (energy dose of 6J), and group 4 (placebo).~   "
24050|NCT03252171|"~     The purpose of this study is to evaluate the safety and effectiveness of CAR-T cell~     immunotherapy in treating with GD2 positive glioma patients.~   "
24051|NCT03252158|"~     Background: While there is some evidence that increasing the range of healthier foods and~     drinks and/or decreasing the range of less healthy options may increase healthier choices,~     more work is needed to establish the reproducibility of any effect. The current study aims to~     investigate the impact of altering the availability of healthier and less healthy foods and~     cold beverages in hospital vending machines.~      Methods: An adapted multiple treatment reversal design will be used, in which all standard~     vending machines serving snack foods and/or cold beverages in one hospital in England change~     the number of slots containing (i) less healthy items and (ii) healthier items over eight~     4-week periods. Changes will take place in a two-step process whereby decreases are~     implemented in a separate study period prior to increases in the contrasting food group.~     Following a 4-week baseline period, all vending machines will be standardised to have 75%~     healthier drinks and/or 25% healthier snacks (study period 1). Vending machines (n=9) will be~     randomly allocated to the order in which they: (1) decrease less healthy foods and increase~     healthier foods or (2) decrease healthier foods and increase less healthy foods (study~     periods 2&3 and 5&6). After each decrease-increase pair, machines will return to the~     standardised 75% healthier drinks and 25% healthier snacks (study periods 4 and 7). Sales~     data will be obtained via records of machine restocking.~      Planned Analysis: The impact of the availability intervention will be assessed in separate~     linear mixed models for cold drinks and snacks, examining the impact on total energy (kcal)~     purchased, per restocking interval, with random effects for vending machine.~   "
24055|NCT03252106|"~     In this prospective case series study, 20 patients with an implant-borne single crown~     following early implant placement with simultaneous contour augmentation will be followed for~     10 years. Clinical, radiologic, and esthetic parameters will be assessed. In addition, cone~     beam computed tomography (CBCT) will be used at 10 years to examine the facial bone wall and~     compared to the 6 year data.~   "
24056|NCT03252093|"~     Coronary Artery Bypass Graft (CABG) is a surgical procedure known to be associated with~     cognitive impairment. Mechanisms of cognitive impairment are complex but may include~     insufficient oxygenation and inflammation due to exposure to the bypass circuit. Currently~     there are no approved therapeutics for the prevention or treatment of cognitive impairment in~     these patients.~      A small peptide, Angiotensin-(1-7) [Ang-(1-7)], is known to decrease inflammation in the~     brain in animal models. Early studies in humans have shown it to be safe. This peptide is~     naturally produced by the body and has anti-inflammatory and vasodilatory effects.~     Investigators believe that Ang-(1-7) may be able to help lower the risk of cognitive~     dysfunction in patients undergoing CABG.~      The goal of this project is to explore effects of the experimental peptide Angiotensin-(1-7)~     (Ang-(1-7) in patients undergoing an elective CABG surgery to determine its safety and~     efficacy to prevent cognitive dysfunction in patients undergoing CABG.~   "
24057|NCT03252080|"~     Two hundreds patients with T2DM from the outpatient clinic of The First Affiliated Hospital~     of Chongqing Medical University will be enrolled in this study. Participating subjects will~     be randomly assigned into one of the 2 groups: Group A (n=100) will be placed on the~     short-term intensive education program alone while Group B (n=100) will be placed on the~     short-term intensive education as well as a holistic management for 6 months.~      Diabetes education: The patients of each group will undergo designated education programs in~     4 subgroups. Group A and B will be given the same education classes once a week in the first~     month (total 4 times), 5 hours per class. The education classes will be taught by a dedicated~     team of diabetes specialist doctors and nurses, with the contents including a basic~     understanding of diabetes, diabetic diet, exercise, drug treatments and blood glucose~     monitoring. At the conclusion of the education classes, the patients in Group B then will~     undergo a weekly telephone interview with specialist nurses for 6 months to help patients~     resolve self-management problems while patients in Group A will not. The specialist nurses~     will talk individually with the patients in Group B for 10-15 min per week. The nurses will~     ask the patients about their results of self-blood glucose monitoring, help them find the~     reasons of poor blood glucose control as well as answer the patient's questions.~      Clinical examination: All subjects will complete Audit of Diabetes Dependent Quality of Life~     (ADDQoL) before education classes commence (baseline), at 3 months and 6 months (endpoint)~     after education classes to evaluate their quality of life. All patients will be examined for~     height, weight, blood pressure, FPG, PPG and HbA1c at baseline, 3 months after education~     classes and endpoint. A diabetes specialist nurse will measure the height, weight and blood~     pressure, and assist the subjects to fill the questionnaire. FPG and PPG will be determined~     by the hexokinase method, while HbA1c by high performance liquid chromatography.~   "
24058|NCT03252067|"~     To evaluate azithromycin tear concentrations after one drop of azithromycin eyedrops~     (2.5ml/25mg) in healthy volunteers.~   "
24059|NCT03252054|"~     This is a cross-sectional observational study that investigates the prevalence of memory~     disorders, attention disorders (suggesting delirium), and malnutrition in hospitalized older~     adults (aged 70 years or over) in a tertiary care centre, using rapid screening toos~     (Six-item screener for memory disorders, Months of the Year Backwards Test for delirium, and~     NRS-2002 and Mini Nutritional Assessment Short Form for malnutrition).~   "
24060|NCT03252041|"~     To investigate the feasibility of MRI and MRV in diagnosis of pelvic congestion syndrome.~   "
24061|NCT03252028|"~     Background: Due to anatomical restrictions, the inflammatory response to intra-cerebral~     bacterial infections exposes swollen brain tissues to pressure and ischemia, resulting in~     life-threatening damage. However, diagnosing meningitis in patients after neurosurgery is~     complicated, due to brain tissue damage and changes in cerebrospinal fluid (CSF) caused by~     surgery. Hepatocyte growth factor (HGF) is a local, acute-phase protein. Previous studies on~     community-acquired septic meningitis reported high levels of intrathecal-produced HGF.~      Aim: The aim of present study is to evaluate a new platform for qualitative determination of~     HGF in body fluids and revealing the site of injury.~      Method: Based on a reverse-methachromacy method, strips are prepared. The surface on the~     strip changes colour to blue upon contact with HGF.~      Plan: CSF, urine and sputum of patients that develop fever post neurosurgery are analysed~     with the test and the results compared with conventional diagnostic methods.~      Clinical value: A rapid, equipment-free test gives the opportunity to identify the infectious~     focus in the infected organ long before culture results are available.~   "
24062|NCT03252015|"~     The purpose of this study is to look at how much lasmiditan, study drug, gets into the blood~     stream and how long it takes the body to get rid of it.~      When drugs are taken together, one or all of the drugs used in combination may be affected.~     This study will also evaluate how much lasmiditan and its breakdown products get into the~     bloodstream after taking one dose alone and after taking lasmiditan together with a probe~     drug cocktail. Information about any side effects that may occur will also be collected.~      The study has two parts. Participants will only enroll in one part. This study will last~     about 25 days for group 1 and 22 days for group 2, not including screening. Screening is~     required within 28 days prior to the start of the study.~      This study is for research purposes only and is not intended to treat any medical condition.~   "
24063|NCT03252002|"~     To investigate the safety, tolerability, pharmacokinetics and effects of BAY1101042 in~     healthy male subjects after a single oral dose and multiple once daily dosing for 7 days~   "
24075|NCT03251846|"~     A more convenient blood glucose monitoring system integrated with a responsive mobile health~     app may facilitate improved diabetes control in adolescent and young adult patients with Type~     1 diabetes. The primary aim of this study is to determine if the POPS diabetes management~     system can improve diabetes control in the adolescent and young adult population. The~     investigators hypothesize that use of the POPS diabetes management device and mobile~     application (app) will be associated with lower HbA1C after 6-months of use in adolescent and~     young adult T1D patients.~   "
24076|NCT03251833|"~     Body Mass Index is an index that is commonly used to classify underweight, overweight and~     obesity in adults. It is defined as the weight in kilograms divided by the square of the~     height in meters.The growing epidemic of obesity in our society has become a major public~     health issue where the proportion of overweight and obese among women aged 15-59 have~     increased from 68 percent in 2008 to 76 percent in 2015~   "
24102|NCT03251495|"~     The primary objective of this study is to evaluate the antibody response to the cholera~     vaccine, Vaxchora®, in healthy subjects.~      Investigators also seek to evaluate additional markers of the adaptive immune response~     including plasmablasts, activated B cells, memory B cells, and T cell responses in healthy~     subjects receiving cholera vaccine, produce monoclonal antibodies against cholera, and~     evaluate the safety and reactogenicity in healthy subjects receiving cholera vaccine.~   "
24064|NCT03251989|"~     Background:~      Primary tumors of the brain and spine are those that start in the brain or spine. These~     tumors are rare, accounting for <2% of all cancers diagnosed in the United States. Some of~     these tumors occur in less than 2,000 people per year. Researchers want to study a large~     group of people with this kind of tumor. They want to learn more about the tumors, including~     the risk factors related to how they develop in adults.~      Objective: To collect health and gene data to learn about what changes are associated with a~     rare CNS Tumors, to eventually screen for these changes or target the genes in treatment.~      Eligibility: Adult participants (Bullet) 18 years of age who self- identify as being~     diagnosed with one of 12 rare CNS tumors, including: Atypical teratoid rhabdoid tumor (ATRT);~     Brainstem and midline gliomas; Choroid plexus tumors; Ependymoma; High grade meningioma;~     Gliomatosis cerebri; Medulloblastoma; Oligodendroglioma / Anaplastic oligodendroglioma;~     Pineal region tumors; Pleomorphic xanthroastrocytoma / Anaplastic pleomorphic~     xanthroastrocytoma; PNET (Supratentorial embryonal tumor); Primary CNS sarcoma / Secondary~     CNS sarcoma (Gliosarcoma).~      Design: (Registered Trademark)Participants will be invited to participate through an ad on~     the CERN Foundation website (ependymoma), information on the Neuro-Oncology Branch website~     and other identified advocacy and social media sites and direct mailer to those who have~     already participated in the EO projects. (Registered Trademark)~        -  Interested participants will complete an enrollment form that will be sent to the study~          coordinator.~        -  The coordinator will then send the participant a consent form and schedule a time for~          phone consent.~        -  Participants will complete the Rare CNS tumors Outcomes Survey and once completed, the~          Rare CNS tumors Risk survey.~      (Registered Trademark)~        -  The questions on the Outcomes Survey will include treatment history, symptoms social and~          clinical information and it should take about 25-35 minutes. The Risk survey will cover~          their demographic information, personal medical history, family medical history and~          environmental exposures. This should take about 52 minutes.~        -  Participants who have physical problems can have help with the surveys and forms.~        -  Once the surveys are completed, participants will be mailed a kit to collect saliva for~          germline DNA. Participants will ship the sample to the study team in a prepaid envelope~        -  If the sample is not sufficient, participants will be contacted to give provide an~          additional sample.~   "
24065|NCT03251976|"~     The purpose of this research is to assess the effect of a cardiopulmonary resuscitation (CPR)~     decision aid video on CPR knowledge and end-of-life preferences in women with advanced~     gynecologic malignancy. We will assess the baseline CPR knowledge in our research population,~     gauge the improvement after viewing a decision aid video, and evaluate its effects on patient~     preferences regarding CPR.~   "
24066|NCT03251963|"~     The aim of this research is to better understand how patient-level factors can be used to~     predict the appropriate enoxaparin dose to maximize venous thromboembolism (VTE) risk~     reduction and minimize bleeding.~   "
24067|NCT03251950|"~     Food insecurity increases the risk of obesity, diabetes, hypertension, and cancer. American~     Indians (AIs) in Oklahoma are three times as likely as Whites to be food-insecure (21% vs.~     7%) and have burdens of obesity (42%), hypertension (38%), and diabetes (15%) that exceed~     those of the general US population. While individual-level obesity prevention efforts have~     been implemented with AIs, few environmental interventions to reduce food insecurity and~     improve fruit and vegetable intake have been conducted with tribal communities. Community~     gardening interventions have been shown to increase vegetable and fruit intake, reduce food~     insecurity, and lower BMI among children and adults; however, to date, no such interventions~     have been evaluated with AI families. The proposed study, entitled Food Equity Resource and~     Sustainability for Health (FRESH), will assess the impact of a tribally-initiated community~     gardening intervention on vegetable and fruit intake, food insecurity, BMI, and blood~     pressure in families living on the Osage Nation reservation in Oklahoma.~   "
24068|NCT03251937|"~     To demonstrate the value of multiple modalities and sustained clinically significant pain~     relief in patients with chronic pain when using the Boston Scientific Spectra WaveWriter~     Spinal Cord Stimulator (SCS) System.~   "
24069|NCT03251924|"~     The purpose of this study is to investigate BMS-986226 administered alone or in combination~     with nivolumab or ipilimumab.~   "
24070|NCT03251911|"~     This research study will test how well a new drug affects bronchiectasis or chronic~     bronchitis. The new drug, Ivacaftor (KALYDECO), is a drug that has recently been approved by~     the U.S. Food and Drug Administration (FDA) for patients with a lung disease called Cystic~     Fibrosis (CF). It has not been approved for use in patients with bronchiectasis or chronic~     bronchitis.~   "
24071|NCT03251898|"~     This study hypothesizes that early-onset neonatal Infections are related to premature rupture~     of membrane (PROM) and that early intervention can improve the prognosis of newborns. The~     objective of this study is to analyze the correlation between PROM and early-onset neonatal~     infections and to assess the prognosis of newborns. A cohort study is designed to implement~     the study. The subjects of study group are pregnant women who are diagnosed as PROM or~     chorioamnionitis and whose gestational age is ≥ 24 weeks. The subjects of control group are~     pregnant women without PROM and chorioamnionitis. Control group and research group are paired~     at 1: 1 ratio. The main contents of the study include three aspects. (1) The correlation~     between PROM and chorioamnionitis. (2) The correlation between PROM and early-onset neonatal~     infections. (3) The pathogenesis of intrauterine infection and neonatal infection.~   "
24072|NCT03251885|"~     The aims of the study are to evaluate the rate of ESBL-producing Enterobacteriaceae~     colonization among women in preterm labor, the incidence of maternal vertical transmission of~     ESBL, and the clinical significance of ESBL in preterm infants.~   "
24073|NCT03251872|"~     The main OBJECTIVE of this proposal is to extend our preclinical findings on the role of DNA~     damage and poly(ADP-ribose) polymerases (PARP) inhibition as a therapy for a devastating~     disease, pulmonary arterial hypertension (PAH), to early-phase clinical trials. We, and~     others, have published strong evidence that DNA damage accounts for disease progression in~     PAH and showed that PARP1 inhibition can reverse PAH in several animal models1.~     Interestingly, PARP1 inhibition is also cardioprotective. Olaparib, an orally available PARP1~     inhibitor, can reverse cancer growth in animals and humans with a good safety profile, and is~     now approved for the treatment of ovarian cancer in Canada, Europe and the USA. The time is~     thus right to translate our findings in human PAH. The industry-sponsored clinical research~     on PARP1 inhibitor is currently entirely cancer-oriented. Nonetheless, AstraZeneca Canada~     accepted to support an early phase clinical trial through in-kind contribution, but the~     support from foundations and federal agencies is critical to catalyze early-stage development~     of PARP1 inhibitors for other indications, especially for orphan diseases. A CIHR Project~     Scheme grant will thus be submitted on September 15 2017, proposing a Phase 1, followed by a~     Phase 2 trial that will be conducted in recognized PAH programs throughout Canada. At this~     stage, however, we propose a pilot study to assess the feasibility of the proposed trials in~     the PAH population. The overall HYPOTHESIS is that PARP1 inhibition with olaparib is a safe~     and effective therapy for PAH.~      The primary objective of the study is to confirm feasibility, to support the safety of using~     olaparib in PAH patients, and precise the sample size of the coming Phase 1B trial. The~     feasibility of the comprehensive patient phenotyping that will be proposed within the phase~     1B trial will thus be assessed, in addition to adverse events and efficacy signals.~   "
24074|NCT03251859|"~     The ELECTRA pilot study is a randomized, open-label, pharmacokinetic and pharmacodynamic~     trial designed to evaluate the effect of ticagrelor maintenance dose reduction on platelet~     inhibition in stable patients who recently underwent acute myocardial infarction and were~     treated with percutaneous coronary intervention.~   "
24077|NCT03251820|"~     Electrical status epilepticus during slow wave sleep is a condition in which the epileptic~     patient starts to develop neurocognitive deterioration, any type of seizures and continuous~     electrical activity in the EEG during non rapid eye movement sleep. It is an age related~     condition and will resolve spontaneously at around the age of puberty. However if left~     untreated or treatment is delayed, it may lead to permanent neurocognitive deterioration.~     Thus early diagnosis and treatment is essential in these children to preserve neurocognitive~     function.~   "
24078|NCT03251807|"~     This experimental study will evaluate the effect of combined treatment with low-intensity~     pulsed ultrasound (LIPUS) and functional appliances (twin-block) on the correction of class~     II malocclusion, compared with the control group treated with functional appliances~     (twin-block) only.~      The study sample will consist of 40 patients with class II malocclusion. The sample will be~     allocated randomly into two groups: control group and experimental group.~      The functional appliance (twin-block) will be applied for all patients, while the~     low-intensity pulsed ultrasound (LIPUS) will be applied for the experimental group only. The~     skeleto-dental changes occurring after functional treatment will be assessed using~     cephalometric radiographs; pre and post- treatment changes for each group will be evaluated~     individually, and the two groups will be compared.~   "
24079|NCT03251794|"~     Preterm birth continues to be a major public health problem with lasting family and societal~     repercussions. Despite tremendous research effort, prevention strategies have failed, and the~     prevalence of preterm birth in the United States reached 12.3% in 2003.~      Prematurity causes 70% of fetal/neonatal deaths. 11.4% of births are at < 37 weeks'~     gestation. The rate of prematurity increases dramatically with the number of fetuses -~     singletons 10%; twins 54.9%; and triplets 93.6%~   "
24080|NCT03251781|"~     Background: The ability to perform activities of daily living (ADL) in patients with chronic~     obstructive pulmonary disease is often impaired. Glittre-ADL Test has been used to assess~     limitations in ADL, and it seems to be responsive to intervention. However, the minimal~     detectable change for Glittre-ADL Test remains unknown. Design: Non-controlled before and~     after study. Setting: The study will be conducted in an outpatient pulmonary rehabilitation~     program in Florianopolis, Brazil. Subjects: Patients with COPD (GOLD II-IV). Interventions:~     Pulmonary rehabilitation program based on physical training, conducted over 24 sessions~     supervised, three times a week, including aerobic training in treadmill and localized~     training for upper limbs and lower limbs. Main measures: Glittre ADL-Test performance,~     six-minute walk test performance, London Chest Activity of Daily Living score, Modified~     Medical Research Council score, COPD Assessment Test score, Saint George Respiratory~     Questionnaire score before and after the pulmonary rehabilitation program.~   "
24081|NCT03251768|"~     Evaluation of the efficacy and safety of recombinant human serum albumin /~     granulocyte-stimulating factor fusion protein for injection to prevent chemotherapy-induced~     neutropenia~   "
24082|NCT03251755|"~     According to the data from WHO, currently there are 350 million people with diabetes mellitus~     in the world, and the amount of which is still increasing. Among all types of diabetes~     mellitus, people with type 2 diabetes mellitus are at most, and the proportion of which in~     Taiwan is 98%. One third of the group suffers from sleep disorder. The prevalence rate is~     33.7-52%, similar with the abroad prevalence rate (38.4%), but it's much higher than the~     prevalence rate of the general public(20.8%). As a result, people with diabetes mellitus are~     at high risk of sleep disorder. Not having enough sleep or sleep badly tend to cause abnormal~     metabolism, which influence the control of glycemia and worsen the disease. Currently~     investigations emphasize prevalence rate, risk factors and diabetes mellitus, increasing~     glycemia, complications which result from lack of sleep. Primary improving methods include~     the improvement of sleeping environment, recommendation of healthy diet, exercise and getting~     oriental medicine treatment. At the present time, WHO is actively promoting the combination~     of oriental treatment. Consequently, expecting the intervention of Dao-in(Chinese Yoga) could~     help to improve sleep quality, HbA1c rate and oriental medicine constitution, in order to~     decrease the incidence of complications and improve the quality of life, which could also~     decrease the expense of medication and act as a health care for diabetes mellitus patients.~   "
24083|NCT03251742|"~     The human heart has 4 chambers: 2 collecting chambers (atria) and 2 pumping chambers~     (ventricles) to allow blood flow within two distinct circuits: pulmonary and systemic.~     The pulmonary circuit directs the blood to the lungs to receive oxygen and the systemic~     circuit delivers oxygen-rich blood throughout the body. In children born with a single~     ventricle, blood from these two circuits mixes within the heart resulting in lower oxygen~     levels in the blood delivered to the body (cyanosis).~      The Fontan procedure is a palliative surgery which bypasses the need for a ventricle to~     deliver blood to the lungs, as blood from the body flows passively to the lungs by a man-made~     connection (whereby two large body veins [cavae] are sewn to the pulmonary arteries), thereby~     preventing mixing of blood through restoration of two distinct circuits without mixing of~     blood. Although the Fontan operation effectively eliminates cyanosis and enables survival~     into adulthood, increased systemic venous pressure is an unavoidable systemic complication~     and low cardiac output (CO) is pervasive finding.~      Despite excellent pediatric surgical results, the risk of late complications and death~     dramatically increases in the decades following Fontan surgery. A chronically low CO state~     secondary to decreased forward flow of blood to the lungs can result in end-organ dysfunction~     and shortened life expectancy. Short of heart transplantation, deemed suitable only for a~     minority of patients, effective therapies for low CO are largely absent. The investigators~     aim to investigate a novel, non-invasive, ambulatory therapy which can augment CO.~     Specifically, external suction is applied intermittently to the chest wall, much like a~     vacuum, to increase CO, called negative pressure ventilation (NPV) using a Cuirass®~     ventilator (Hayek Medical). Although used in patients with lung disease, the investigators'~     proposal is to evaluate this novel, portable, ventilation system would be the first study of~     its kind in adults with congenital heart disease, specifically those with a Fontan~     palliation.~   "
24084|NCT03251729|"~     The aim of this study is to evaluate the efficacy of cervical cerclage in prevention of~     spontaneous preterm birth in singleton pregnancies with a short transvaginal cervical length~     (<=25mm) and without prior spontaneous preterm birth~   "
24085|NCT03251716|"~     In early clinical study investigators confirmed that berberine could prevent glucose and~     lipid metabolism disorder in schizophrenia, so investigators intend to verify the effect and~     safety of berberine in treatment for metabolic syndrome in schizophrenia.~   "
24086|NCT03251703|"~     Shoulder pain is the second most common musculoskeletal disease in adults, and it often~     becomes chronic due to treatment difficulties.~      Pulsed radiofrequency (PRF) therapy has become increasingly popular in the treatment of~     chronic shoulder pain due to its long duration of action and non-destructive method.~   "
24099|NCT03251534|"~     This observational study is a collection of clinical and imaging data of patients with a~     femoral shaft fracture treated by nails. The aim of this research is the contribution of the~     EOS imaging system in the quantification of malunions.~   "
24087|NCT03251690|"~     According to the Thai National Guidelines for Treatment of HIV/AIDS 2014, the recommended~     first line ART regimen was 2 NRTIs backbone, TDF and FTC; plus 1 NNRTI, EFV, with RPV as an~     alternative one. Most of the randomized-controlled studies, including ECHO and THRIVE, showed~     the non-inferiority of RPV compared with EFV in naive cases. But there were not much~     randomized-controlled trials for changing from other NRTI to RPV in patients who currently on~     another ART, especially in Thailand. Moreover, the concerned adverse effects of dyslipidemia~     and neurological symptoms were better in RPV-based than EFV-based regimen. Finally, the~     cost-effectiveness and universal coverage are also the benefit of RPV over EFV in term of~     economics.~   "
24088|NCT03251677|"~     The objective of this study is to compare the perioperative outcomes between mini-lap~     hysterectomy and total laparoscopic hysterectomy (TLH) because of benign indications.~   "
24089|NCT03251664|"~     This study investigates the association between locally consumed food items with anemia among~     pregnant women, in Addis Ababa city, Ethiopia.~   "
24090|NCT03251651|"~     Delirium occurs commonly in elderly patients. Its incidence after orthopedic surgery has been~     reported to be 5-61%. Delirium is classified into three sub-types: Hypoactive, hyperactive,~     and mixed. Although hyperactive delirium is not as common as hypoactive delirium, the~     abnormal behavior pattern of hyperactive delirium, such as agitation, confusion, or~     aggressiveness, is considered to be harmful to patients and medical personnel. Thus, it is~     important to promptly manage such behaviors associated with hyperactive delirium.~     Intraoperative sedation plays an important role in relieving anxiety or stress response of~     patients. Propofol—a common sedative agent—was reported to cause delirium more frequently,~     compared with dexmedetomidine, in post-cardiac surgery patients or mechanically-ventilated~     patients in the intensive care unit (ICU). In addition to the benefits of reducing opioid~     consumption and postoperative nausea/vomiting, dexmedetomidine is most often used for ICU~     sedation or procedural sedation. However, there has not been any prospective randomized study~     investigating how intraoperative dexmedetomidine sedation during regional anesthesia affects~     postoperative consciousness, perception, memory, behavior, emotion, and so on. In this study,~     based on the hypothesis that intraoperative dexmedetomidine sedation may reduce the incidence~     of abnormal psycho-motor behavior compared with propofol sedation, investigators~     prospectively will investigate the incidence of postoperative delirium in elderly patients~     who undergo orthopedic surgery with regional anesthesia.~   "
24091|NCT03251638|"~     Hearing loss is one of the most common congenital anomalies. Early Intervention at or before~     6 months of age allows a child with impaired hearing to develop normal speech and~     language.Auditory brainstem response , otoacoustic emissions testing have all been used in~     newborn hearing-screening programs~   "
24092|NCT03251625|"~     1. To assess the effect of multistrain probiotics on abdominal pain using a validated~          symptom severity score in IBS patients.~        2. To assess the efficacy of a multi-strain probiotic supplement as a treatment option for~          IBS in a tertiary referral centre~   "
24093|NCT03251612|"~     The purpose of the present study is to investigate the benefit of anti-cancer therapy~     administered on the basis of drug sensitivity testing. This concerns colorectal cancer~     patients who have previously received standard treatment.~   "
24094|NCT03251599|"~     Glyceryl trinitrate is used in coronary artery bypass grafting surgery. This surgery~     frequently employs hypothermic cardiopulmonary bypass, where the whole body is cooled down to~     28-32 °C to arrest the heart, and protect the organs from ischemic insult. When the cardiac~     repair or grafting is done, the body is warmed to 37 °C. During this rewarming period, the~     heart has to beat against the vessels, all of which are constricted due to hypothermia.~      To overcome this constriction of the vessels, and decrease the workload of the heart,~     glyceryl trinitrate is infused. This drug causes significant dilatation in arteries and~     veins, which allows the heart to pump the blood with less force. The dilatation of the~     vessels also allows the body to rewarm more easily.~      The investigators' concern is whether increased infusion rates of glyceryl trinitrate may~     cause uncontrolled rewarming of the brain or not. The investigators will measure the~     temperature of the brain using a temperature probe located in the nasal cavity. The~     temperature will be recorded at each minute during the the rewarming period. Results of two~     commonly used infusion rates of glyceryl trinitrate will be compared.~   "
24095|NCT03251586|"~     Test-Retest Reliability of ocular vestibular evoked myogenic potentials (oVEMPs) across~     different electrode montages.~      The purpose of this project is to compare the response characteristics of the ocular~     vestibular evoked myogenic potential in patients grouped by decade (i.e. 20's-90's) using two~     different recording montages and two different stimulus types (i.e. air and bone conducted~     sound). The long-term goal is to increase the sensitivity and specificity of the oVEMP when~     used clinically to identify vestibular disorders affecting the utricle and superior portion~     of the vestibular nerve.~   "
24096|NCT03251573|"~     This study is going to apply neuropsychological battery tests to measure cognitive function~     across multiple cognitive domains in our cohort of 600 maintenance hemodialysis patients and~     evaluate:~        1. The presence and patterns of cognitive impairment in domains of executive function,~          perceptual-motor function, language, learning and memory, and complex attention;~        2. Clinical characteristics of participants with and without cognitive impairment;~        3. the risk factors which might be related to cognitive impairment in this group of~          population;~        4. The association between cognitive impairment and all-cause mortality, stroke and~          non-fatal cardiovascular events;~      We hypothesize that hemodialysis patient is going to have cognitive impairment which might be~     associated with some risk factors. We also anticipate that cognitive impairment might have~     some kind of association with the clinical outcomes like all-cause mortality, stroke and~     other common clinical outcomes that we mentioned above.~   "
24097|NCT03251560|"~     A prospective random control clinical trials to research Fuke Qianjin capsule's effects on~     ameliorating the pain caused by chronic pelvic disease.~   "
24098|NCT03251547|"~     This is a retrospective descriptive study, to study the treatment indications, changes in~     transfusion need, coagulation profiles changes and clinical outcome (survival, complication)~     of non-haemophiliac patients who received activated factor seven (rFVIIa / NovoSeven®) during~     massive bleeding in Hospital Universiti Sains Malaysia (HUSM)~   "
24103|NCT03251482|"~     The primary purpose of Part 1 in this study is to assess the safety and tolerability of~     JNJ-64179375 for each dose level for dose escalation and any bleeding events (the composite~     of major, clinically relevant non-major, and minimal bleeding events) for the selection of~     doses for Part 2. The primary purpose of Part 2 is to assess the efficacy dose response of~     JNJ-64179375 for the prevention of total venous thromboembolism (VTE) (proximal and/or distal~     deep vein thrombosis [DVT] [asymptomatic confirmed by venography assessment of the operated~     leg or objectively confirmed symptomatic], nonfatal pulmonary embolism [PE], or any death).~   "
24104|NCT03251469|"~     The aim of this study is to investigate the hypothesis that single dose of tranexamic acid~     (TXA) preoperatively will lower blood loss and transfusion rate in elderly patients with hip~     fractures (intertrochanteric or Subcapital), that will be treated with intramedullary nailing~     and cemented hemiarthroplasty respectively. After application of inclusion and exclusion~     criteria, patients will be randomized in two groups. Group 1 will include patients that~     receive preoperatively single dose of TXA (15mg/kg) and Group 2 will include patients that~     receive normal saline (control group).~   "
24105|NCT03251456|"~     Visual development disorders are major public health problems among children especially in~     China. How to find an effective and economic way to manage the larger number of children in~     China remains exploring. The national basic public health services of China offer visual~     acuity screening for preschool children for free every year. The aim of this study is to~     demonstrate the feasibility, cost-effective and the influence factors of compliance of~     tertiary care for visual developmental disorders in pre-school children after screening, and~     whether this disease management model is more effective and superior than the current medical~     care in china.~   "
24106|NCT03251443|"~     The purpose of this study is to explore the efficacy and safety of second-line treatment of~     apatinib in advanced intrahepatic cholangiocarcinoma patients and evaluate drug safety,~     progression free and overall survival. The primary endpoint of this study is objective~     response rate (ORR), disease control rate (DCR) and progression-free survival (PFS).~   "
24107|NCT03251430|"~     Osteoporosis after gastrectomy, which is characterized by both the loss of bone mass and the~     deterioration of bone architecture, is a serious complication in the long course after~     gastrectomy. The aim of the present study was to evaluate osteoporosis by using~     high-resolution peripheral quantitative computed tomography (HR-pQCT) in the long course~     after gastrectomy. In total gastrectomy and distal gastrectomy groups, at least 5 years~     should have elapsed since gastrectomy.~   "
24108|NCT03251417|"~     Esophageal cancer is a common malignant disease worldwide especially in china. Though~     esophagectomy and definitive chemoradiotherapy are standard treatments, disease relapses in~     many patients and the prognosis of metastatic ESCC is still poor. For patients with~     unresectable or metastatic ESCC, chemotherapy is an important treatment alone or with~     radiotherapy. Taxane, platinum, and fluoropyrimidine have been reported effective in ESCC and~     is used as first-line treatment of ESCC. As for 2nd-line treatment, both irinotecan and~     taxane had been recommended based on data from clinical trials which were most enrolled~     esophageal or esophageal-gastric junction adenocarcinoma and with only small sample size.~     Therefore, it is still urgently needed to explore effective 2nd-line treatment for ESCC.~      Apatinib, also known as YN968D1, is an orally antiangiogenic agents. Preclinical and clinical~     data had shown that it is effective in the treatment of a variety of solid tumors including~     esophageal cancer. It had been approved as a 3rd-line treatment for patients with advanced~     gastric cancer by state FDA of China in 2014. And the safety data showed that hemorrhage is~     rare and non-fetal which is different from bevacizumab.~      Therefore, the investigators initialize this phase II study to explore the efficacy and~     safety of irinotecan and apatinib combination treatment in unresectable or metastatic ESCC~     patients who failed in 1st-line chemotherapy or chemoradiotherapy.~   "
24109|NCT03251404|"~     This study evaluates the effects of two different injury prevention exercise programs on~     sports-relevant performance tests and neuromuscular function in youth football players. Half~     of participants will receive education on an existing and previously tested exercise program,~     while the other half will receive education on a newly developed exercise program.~   "
24110|NCT03251391|"~     The main purpose of this study is to see if it is safe and feasible to use cardiac~     rehabilitation (CR) in patients with peripheral arterial disease (PAD) after successful~     revascularization. This study will also test if CR improves quality of life and health~     outcomes in PAD patients.~   "
24111|NCT03251378|"~     An open-label, dose escalation clinical trial to evaluate the safety, tolerability, and PK of~     fruquintinib in patients with advanced solid tumors.~   "
24112|NCT03251365|"~     A randomized, multidisciplinary study, Phase II-III clinical trial.The study is opened to the~     incorporation of other centers that would increase the power of the obtained results . Our~     hypothesis considers that using Hyperthermic Intra-abdominal Chemotherapy,HIPEC, with~     gemcitabine after cytoreductive surgery ,will decrease tumor progression of pancreatic cancer~     by reducing the neoplastic volume and subpopulation of pancreatic cancer stem cells,~     improving the survival of patients with pancreatic cancer, and decreasing the recurrence of~     the disease~   "
24113|NCT03251352|"~     The primary objective of this study is to describe the maintenance of the molecular remission~     after tyrosine kinase inhibitor (TKI) disconnection in chronic myeloid leukaemia (CML)~     patients in China in the real-world clinical practice setting. This is a post-marketing,~     non-interventional, single-arm, prospective registry study in adult patients with chronic~     phase (CP) and accelerated phase (AP) in China. Patients will be recruited consecutively from~     the study sites during the enrollment period. The enrolled patients will be undertaking TKI~     discontinuation under the conditions of informed consent and frequent monitoring according to~     the clinical guideline.~   "
24114|NCT03251339|"~     The primary purpose of this study is to compare the immunogenicity and safety of MSB11455 and~     Neulasta in healthy adult subjects.~   "
24115|NCT03251326|"~     Despite the prevalence of cannabis use among the PTSD population and self-reports that it is~     used to help cope with PTSD symptoms, the direct effects of cannabis on PTSD symptomology are~     unknown. The purpose of this placebo-controlled, within-subject study is to assess the~     effects of smoked cannabis and orally administered nabilone, a synthetic analog of THC, the~     primary psychoactive component of cannabis on multiple dimensions of PTSD symptomatology in~     cannabis smokers with PTSD.~   "
24118|NCT03251287|"~     Inorganic nitrate, which is found at high levels in green leafy vegetables, is reduced to~     nitrite by bacteria in the mouth, swallowed, and absorbed in the stomach into the blood.~     Studies have shown that increasing the blood levels of nitrite improves the way that muscles~     use oxygen and energy during exercise, and potentially blood flow.~      Some people (~1 in 500) suffer from a type of genetic heart condition known as hypertrophic~     cardiomyopathy (HCM). This condition means that the muscle in the heart does not use energy~     well and becomes larger than average, meaning that they have to tap into the heart's 'energy~     reserves'. It is not known if nitrite has the same beneficial effects on heart muscle as on~     other muscles in the body. Our study will explore the mechanism by which nitrite may improve~     the function and energy status of the heart in HCM.~   "
24119|NCT03251274|"~     The study is divided into two stages, the purposes of the first stage are (1) to examine the~     feasibility and simplicity of the operation of bathtub machine for nurse aides; (2) to~     examine the safety and comfortability of the bathtub machine from the perspectives of the~     nurse aides. The purposes of the second stage are (1) to understand the experiences of nurse~     aides and the elderly with disability by using the bathtub machine(which has edde massage~     function); (2) to evaluate the effectiveness of using the bathtub machine on the sleep~     quality and body temperature in the elderly with disability.~   "
24120|NCT03251261|"~     To evaluate the illumigene CMV assay, using the illumipro-10 with neonates (up to 21 days of~     age) saliva swabs~   "
24121|NCT03251248|"~     The purpose of the study is to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of~     MSB11455 and Neulasta in healthy adult subjects.~   "
24122|NCT03251235|"~     Exposure-based cognitive-behaviour therapy (CBT) for anxiety disorders is an effective~     intervention, but the brain mechanisms driving recovery are largely unknown. In this~     experimental medicine study, it will be investigated to what degree CBT affects neural~     markers of anxiety at an early stage of treatment, to identify dynamic mechanistic changes~     which might be crucial in the process of recovery as opposed to those seen following full~     treatment completion. Patients with panic disorder will be recruited and randomly allocated~     to a group receiving 4 weekly sessions of cognitive-behaviour therapy versus a waiting group~     not receiving any interventions until after the experimental procedure.~   "
24123|NCT03251222|"~     For patients with eye surgery and shorter surgery, sedation is a well-established method in~     preserved consciousness and has been successfully used for several years. We have also~     developed and published a valid protocol (1).~      Remifentanil is used in intravenous infusion for sedation and anxiolysis. Remifentanil is a~     descriptive analgesic, which also works partially anxiolytically. In eye surgery, it is~     important that the patient cooperates during the operation and should not be ashamed, as~     injury to the eye could occur, because the vitrectomes are performed with a fine intraocular~     endoscopic technique, in which the operator inserts his instruments through the whiteness~     into the eye. For this reason, we have not yet added additional sedatives (for example,~     midazolam), which is very unpredictable as regards sedation. Remifentanil is also very~     unpredictable and it is very difficult to control it during the operation so that the patient~     is saturated with satisfaction.~      Lately, dexmedetomidine has been successfully used in sedation for other areas of surgery (eg~     neurosurgery, maxillofacial surgery, ORL). It is a safe, proven, active substance with alpha~     2 agonistic effect, which has not yet been used in the field of ocular surgery and has not~     yet published articles in this field. The substance is very suitable because it works mildly~     sedative and at the same time analgesic.~   "
24124|NCT03251209|"~     Among the limitations caused by cerebrovascular accident (CVA), the upper limb (MS) undergoes~     changes that limit the individual in his ability to maintain an active social life. Mental~     Practice (MP) consists of the internal reproduction of an event, which is repeated~     extensively in order to learn or improve an already known skill. The objective of the study~     is evaluate the effects of the physical practice associated with PM, on paretic MS. Subjects~     with unilateral stroke over 6 months, age> 18 years and who were able to hold objects will be~     selected. Subjects with painful conditions that affected exercise performance,> 3 spasticity~     by Ashworth, and cognitive deficit suggested by the Mini Mental State Examination will be~     excluded.~   "
24125|NCT03251196|"~     This is an observational cohort study. Pulmonary tuberculosis (TB) patients will be enrolled~     at the time of TB diagnosis and prospectively followed for at least two years after~     TB-treatment initiation with optional prolonged follow-up. Study visits will be performed in~     the study clinics or if necessary at the participant's home at pre-defined time points after~     TB treatment initiation. Clinical assessments, biological sample collections and collection~     of socio-economic data will be performed according to the pre-defined schedule of events.~   "
24126|NCT03251183|"~     Heart failure (HF) currently affects app. 2% of the western population and app. 10% of people~     >75 years. In about 50% of patients with symptomatic HF ejection fraction (EF) is preserved~     (HF-PEF). Once patients develop symptoms, the prognosis is poor with 25% mortality at 1 year~     and 50% mortality at 5 years. HFpEF is one of the major unresolved areas in clinical~     cardiology. The diagnosis of HFpEF remains a diagnosis of exclusion and currently no~     non-invasive measure provides a clear diagnosis.~      Cardiovascular magnetic resonance (CMR) provides non invasive and radiation free evaluation~     of heart structure and function. New CMR parameters offer the possibility to describe the~     underlying pathological and physiological changes associated with HFpEF.~      The investigators propose to undertake the first systematic comparison between a CMR protocol~     and invasive haemodynamics as the best possible gold standard, as well as define the~     histopathological drivers in myocardial biopsies. The investigators will also examine the~     relations with tissue and serological biomarkers implicated in HFpEF and the role with~     standard and novel parameters by echocardiography. If successful, this study will provide~     tools for a reliable and accurate non-invasive characterization of patients with HFpEF,~     supporting the diagnosis and grading the severity of disease. This study will provide a~     reference basis for future diagnostic algorithms in HFpEF, both, for CMR and~     echocardiography, but also for their relative value in comparison to blood markers or~     invasive testing. In addition to a new pathway to acess the effects of current and novel~     therapeutic interventions, the investigators see the greatest potential in identifying a~     disease stage where the myocardial injury may be reversible.~   "
43035|NCT03003468|"~     This is an open label, multi-institutional, single arm study with a dose escalation phase Ib~     cohort, followed by a phase II cohort of pembrolizumab and Imprime PGG. No randomization or~     blinding is involved.~   "
24128|NCT03251157|"~     The Nutrition Study of the GA2LEN Follow-Survey was designed to investigate the association~     between usual dietary intake and allergic and respiratory outcomes in adults across Europe.~     Within this framework, a food frequency questionnaire (FFQ) was designed to ascertain usual~     dietary intake of 250 food items, which was translated into the languages of the participant~     centres. Information on daily intake of foods, nutrients, and flavonoids was derived.~   "
24129|NCT03251144|"~     Increased comorbidities such as cardiovascular disease (CVD), are emerging problems in HIV~     infection but the mechanisms are unclear. Understanding how antiretrovirals can minimize~     morbidity in treated HIV infection is a research priority. Nucleoside/nucleotide reverse~     transcriptase inhibitors (NRTIs) are included in all HIV treatment regimens. Tenofovir (TFV)~     disoproxil fumarate (TDF) has been associated with an increased risk of nephrotoxicity and~     bone disease compared with other NRTIs. Tenofovir alafenamide (TAF) is an oral prodrug of~     TFV, but is more stable in plasma as compared with TDF and lower plasma levels of TFV are~     thought to lead to the favorable safety profile of TAF. Mitochondrial dysfunction has a key~     role in HIV pathogenesis and may be the common denominator that drives pathogenesis of~     several comorbidities. Despite the better safety profile of newer (such as TDF) compared to~     older NRTIs, there are concerns for the potential for longer term toxicity of NRTIs since the~     exact cellular effects of NRTIs remain unclear. It is unknown whether a four-fold increase in~     intracellular drug levels seen in peripheral blood mononuclear cells (PBMCs) with TAF may~     increase toxicity in mitochondria. Better understanding of these effects could provide~     insights into mechanisms of HIV pathogenesis and selection of NRTIs that improve morbidity in~     chronic HIV infection.~      Hypothesis: Despite higher intracellular levels, TAF has minimal mitochondrial toxicity~     compared to TDF in vivo. This research will explore the relative mitochondrial toxicity of~     newer NRTIs (TAF, TDF) as a possible mechanism for differential NTRI-related toxicities.~     These data will allow selection of NRTIs that may improve morbidity in chronic treated HIV~     infection. Towards this aim, the investigators will use a robust experimental approach to~     study NRTI-related mitochondrial dysfunction using novel methods, human cell lines and PBMC.~     Our specific aims are: Aim 1: To evaluate the relative in vitro effects of TAF and TDF~     compared to an older NRTI (ddC) on 5 independent measures of mitochondrial function in the~     human cell line HepG2 and PBMC. Aim 2: To explore in vivo whether there is increased~     mitochondrial dysfunction with the use of TAF vs. TDF in chronic treated HIV infection. The~     investigators anticipate that the proposed experimental approach will set the basis for~     future large scale studies to directly compare subtle potential mitochondrial toxicities of~     newer NRTIs in large HIV cohorts.~   "
24130|NCT03251131|"~     Observational studies among patients with acute kidney injury (AKI) have shown an association~     with fluid accumulation and increased mortality. Trials among other subgroups of critically~     ill patients have demonstrated that restricting fluid input after the initial resuscitation~     appears safe.~      The objective if this study is to determine whether a fluid restrictive treatment regimen~     will lead to a lower cumulative fluid balance at 72 hours from randomization in critically~     ill patients with AKI and whether this approach is safe and feasible.~   "
24131|NCT03251118|"~     TARGET-IBD is a 5-year, longitudinal, observational study of adult and pediatric patients~     (age 2 and above) being managed for Inflammatory Bowel Disease (IBD) in usual clinical~     practice. TARGET-IBD will create a research registry of patients with IBD within academic and~     community real-world practices in order to assess the safety and effectiveness of current and~     future therapies.~   "
24132|NCT03251105|"~     In this study, the Supreme and ProSeal LMAs in infants were compared by measuring their~     performance characteristics, including insertion features, ventilation parameters, induced~     changes in hemodynamics and rates of postoperative complications.~   "
24133|NCT03251092|"~     Part 1 of this trial will enroll healthy volunteers into a single ascending dose (SAD),~     multiple ascending dose (MAD), and Food Effect (FE) treatment groups.~      The SAD treatment group is comprised of at least 3 ascending dose level cohorts where healthy~     adult subjects will be randomized to receive a single dose of either PTI-808 or placebo and~     will be followed for 7 days post dose. A safety review committee (SRC) will convene after the~     completion of each cohort to evaluate safety and pharmacokinetic (PK) data.~      Following the conclusion of the respective SAD level dose groups and after sufficient review~     of study data and approval by the SRC, a second set of healthy adult subjects will~     participate in an assigned MAD treatment group. The MAD treatment group is comprised of 3~     ascending dose level cohorts where subjects will be randomized to receive either PTI-808 or~     placebo daily for 7 days and will be followed for 7 days after receiving the last dose.~      Also following the conclusion of the respective SAD level dose groups, healthy adult subjects~     will participate in the FE treatment group.~      Part 2 of this will enroll healthy volunteers to assess the safety, tolerability, and PK of~     PTI 808 co administered with PTI 801 and PTI 428 to HVs with daily dosing for 7 consecutive~     days.~      Part 3 will enroll adult subjects with cystic fibrosis (CF) into a MAD treatment group~     consisting of 3 cohorts. Subjects will receive PTI-808 co-administered with PTI-801 and~     PTI-428. PTI-808 will be administered daily for 7 consecutive days followed by PTI-808 +~     PTI-801 + PTI-428 administered daily for 14 consecutive days.~   "
24134|NCT03251066|"~     Investigation of the immediate effect on subjective relief of symptoms by Proponent - Nasal -~     Spray after a one time administration (following a single dose administration in each~     nostril) in an open, not randomised, non-blinded single centre observation study on 40~     volunteers between 18-75 years of age with an unspecific discomfort in the nose such as~     enhanced nasal discharge/ secretion (runny nose), congested nose, sneezing, itchy nose or~     feeling of a dry nose.~   "
24135|NCT03251053|"~     The purpose of the study conducted at VA Medical Center in Miami is to determine if smoking~     electronic cigarettes (known as e-cigarettes) that contain nicotine have less negative~     effects than regular cigarettes on the person's respiratory health. We will assess this by~     measuring pulmonary function tests, several body molecules and functionality of the airway~     cells. We will also evaluate how smokers can maintain exclusive electronic cigarettes use.~      In this study, some people will continue to smoke regular tobacco cigarettes while others~     will switch to a nicotine-containing electronic cigarette.~   "
24136|NCT03251040|"~     Anastomotic leakage remains a major complication after esophageal surgery. Amongst other~     preventive measures, fibrin sealant is a promising adjunct to conventional anastomotic~     techniques. The investigators aimed to investigate feasibility of additional sealing by means~     of autologous fibrin sealant of the esophageal anastomosis.~   "
24137|NCT03251027|"~     This phase II trial studies how well intensity-modulated stereotactic radiation therapy works~     in treating patients with grade II-IV glioma. Stereotactic radiosurgery is a specialized~     radiation therapy that delivers a single, high dose of radiation directly to the tumor and~     may cause less damage to normal tissue.~   "
24138|NCT03251014|"~     The study aimed to determine the thrombotic effects of YSS compared with salmon among healthy~     overweight subjects. It hypothesized that YSS may result significant, favorable thrombotic~     effects and the effects may be similar with salmon.~   "
24139|NCT03251001|"~     The present split-mouth controlled randomized clinical trial aimed to evaluate clinical and~     histological results of acellular dermal matrix allograft (ADM) compared to autogenous free~     gingival graft (FGG)~   "
24141|NCT03250975|"~     The purpose of this investigation is to delineate the incidence of acute and chronic~     laryngeal injury following intubation within our health system. In addition, this study seeks~     to identify risk factors for airway injury that may provide information to help reduce the~     incidence of injury or increase the speed of diagnosis through hospital based process~     measures.~      Study Aims~        1. Determine the incidence of acute laryngeal injury in patients with prolonged intubation.~        2. Determine the incidence of chronic laryngeal injury in the subset of patients with acute~          laryngeal injury~   "
24142|NCT03250962|"~     The purpose of this study is to evaluate whether treatment with the study drug decitabine in~     combination with SHR-1210 is safe and feasible, is more effective than treatment with~     SHR-1210 alone,and reverse the resistance of Anti-PD-1 antibody in patients with HL.~   "
24143|NCT03250949|"~     Clinical Evaluation Of Dental Implants Stability Placed In Healed Bony Sites Following~     Over-drilling Compared To Conventional-Drilling Protocol~   "
24144|NCT03250936|"~     The aim of this study is to compare trauma related to others sport to trauma due to~     trampoline in pediatric emergencies of Rennes.~   "
24145|NCT03250923|"~     CelAgace™ OraRinse (silver citrate complex and acemannan) Solution is being evaluated for~     safety and effectiveness as a potential treatment for candidiasis, a yeast infection,~     commonly known as thrush, which is associated with mouth sores. CelAgace™ contains two active~     ingredients, a silver citrate complex salt that has demonstrated laboratory effectiveness~     against yeast organisms and acemannan, a purified extract isolated from the inner leaf gel of~     the Aloe vera plant that has been used as a key ingredient in other oral care products.~     Patients will swish and spit the product 4 times daily (after meals and at bedtime) for 14~     days. Following an initial office visit, patients will be evaluated on days 7 and 14 to~     determine response to the product.~   "
24146|NCT03250910|"~     Data are limited regarding the effectiveness and safety of generic velpatasvir plus~     sofosbuvir (VEL/SOF) with or without ribavirin (RBV) for the treatment of hepatitis C virus~     (HCV) in patients with human immunodeficiency virus (HIV) coinfection. We aim to compare the~     effectiveness and safety of VEL/SOF with and without RBV for 12 weeks in HIV/HCV-coinfected~     and HCV-monoinfected patients The antiviral responses and the adverse events (AEs) are~     compare between the two groups. The characteristics potentially related to sustained~     virologic response 12 weeks off therapy (SVR12) are analyzed.~   "
24147|NCT03250897|"~     The aim of the study is to investigate by flow cytometry the phenotype of alveolar~     macrophages (AMs) isolated from patients with non-infectious lung diseases.~   "
24148|NCT03250884|"~     The aim of the study is to evaluate the effectiveness of a rapid pregnancy diagnostic test to~     improve the medical care of patients in emergency room.~   "
24149|NCT03250871|"~     Hypnosis has already shown to decrease pain and anxiety in different surgical specialities.~     Nevertheless, its input has never been studied in cardiology. This research is a prospective,~     monocentric, controlled and randomized study.~      Patients over 18 years old and hospitalized for implantation of a pacemaker or ablation of~     atrial flutter may be included and randomized into one of the arms: placebo or hypnosis.~      Global pain and paroxysmal pain peak will be assessed by a visual analogue pain scale.~     Anxiety will be assessed by a self-administered questionnaire (APAIS) before the procedure~     and by visual analogue pain scale before and after the procedure.~      The aim of this study is to improve the care given to patient undergoing cardiac~     electrophysiology procedure.~   "
24150|NCT03250858|"~     The EatWellUK study aims to investigate the effectiveness of a mobile web application~     (e-Nutri), capable of delivering automated personalised nutrition advice, in increasing diet~     quality.~      Dietary assessment is via the validated Food4Me FFQ (with an updated user interface that has~     been designed for better usability) and dietary feedback is derived according to adherence to~     an 11-item modified US Alternative Healthy Eating Index (m-AHEI).~   "
24151|NCT03250845|"~     The purpose of this observational study is to compare the administration of standard of care~     Multigam IV 5% and standard of care Multigam IV 10% in order to observe changes in infusion~     time and infusion related reactions. Patient satisfaction, number of actions taken by the~     nursing staff during infusion and satisfaction of the nursing staff will also be evaluated.~   "
24152|NCT03250832|"~     This is a multicenter, open-label, first-in-human Phase 1 study evaluating TSR-033, an~     anti-LAG-3 Monoclonal Antibody, alone and in combination with an anti-PD-1 in Patients with~     Advanced Solid Tumors in a broad range of solid tumors. Patients with disease types selected~     for evaluation in this study are expected to derive clinical benefit with addition of an~     anti-PD-1. The study will be conducted in two parts: dose escalation and cohort expansion.~   "
24153|NCT03250819|"~     Glaucoma is one of the most prevalent eye diseases and the second most common cause of~     blindness worldwide. The most common form is primary open angle glaucoma (POAG). Glaucoma is~     a slowly progressing neuropathy of the optic nerve that causes loss of visual field and~     eventually blindness. Elevated intra-ocular pressure (IOP) is the most important risk factor.~      Corticosteroids, which are often used for the treatment of many diseases in ophthalmology and~     other specialities, may cause an elevation of the IOP. It is estimated that corticosteroids~     induce ocular hypertension in approximately 18%-36% of the general population and in patients~     with POAG this percentage can be as high as 92%. When the treatment is sustained, this can~     cause a glaucomatous neuropathy of the optic nerve (corticosteroid-induced glaucoma).~      The precise pathogenic mechanism isn't clear yet. Genetic factors are likely to affect the~     susceptibility to corticosteroid response. Therefore, an overview of the genetic mechanisms~     of corticosteroid-induced glaucoma can give more insight in the pathogenesis. In this study~     the researchers investigate the occurrence of SNPs (single nucleotide polymorphisms) in 150~     cases with a steroid-response in comparison with 300 controls exposed to corticosteroids~     without a steroid-response.~      Up to now, one small GWAS has been conducted comparing 32 patients with and without~     corticosteroid-induced ocular hypertension after treatment with intravitreal triamcinolone.~     In this study, two SNPs proximal of the transcriptional start site (near the 5') of HCG22 on~     chromosome 6 were identified. However, this is a rather small sample population and the~     investigators didn't match for the underlying disease. Further, in another small study,~     Hogewind et al. performed SNP analysis in multiple genes (SFRS3, FKBP4, FKBP5, and NR3C1) in~     corticosteroid-induced ocular hypertension.~      This study enables the investigators to identify patients at risk for developing~     corticosteroid-induced glaucoma and to gain a better insight in the pathogenesis. This may~     also lead to the discovery of biomarkers that indicate an increased risk of developing a~     steroid-induced glaucoma and new prevention and treatment strategies, which are necessary as~     the treatment of corticosteroid induced-glaucoma now only focuses at lowering the IOP and can~     still be challenging.~   "
24154|NCT03250806|"~     Prospective cohort study to test the hypothesis that patients identified with severe aortic~     stenosis are under-diagnosed and under-treated. Such patients shall be identified by~     auscultation or target echocardiography during flu vaccination. The hypothesis is that this~     will increase detection of aortic stenosis in the community.~   "
24155|NCT03250793|"~     Congenital diaphragmatic hernia (CDH) is a congenital malformation associated with~     significant mortality and respiratory morbidity, particularly related to prolonged mechanical~     ventilation. NAVA (Neurally Adjusted Ventilatory Assist) is a recent technique that uses the~     recognition of the electrical activity of the patient's diaphragm (Edi) and delivers a~     synchronized proportional assisted ventilation. This technique has already been used in the~     newborn, especially premature and has shown many benefits. Only one study in the literature~     shows its feasibility in newborns with CDH. This technique seems interesting in the context~     of CDH because it would limit baro-trauma and improve synchronization. Before demonstrating~     the clinical benefits, it seems important to describe the effects on the respiratory~     physiology, in particular on work of breathing which can be estimated by the esophageal and~     trans-diaphragmatic pressure-time product obtained by an esophageal transducer. Our study is~     an innovative physiologic pilot study with the objective to describe work of breathing in~     neonates with CDH in post-surgical period in NAVA ventilation and in conventional ventilation~     using an esophageal transducer. It will provide the clinician with a physiological~     justification for the use of NAVA to rapidly improve the respiratory muscular dynamics of~     these patients. This study is a prerequisite for the realization of studies demonstrating the~     clinical benefit of NAVA ventilation on reduction of duration of ventilation and more~     generally on morbidity and mortality in the population of neonate with CDH.~   "
24156|NCT03250780|"~     Patients with longstanding ulcerative colitis (inflammatory bowel disease, IBD) have~     increased risk of developing colorectal cancer (CRC) when compared with that of the general~     population. Therefore patients with longstanding colitis undergo regular screening~     colonoscopy at varied time intervals depending on their individual risk. This is thought to~     detect early mucosal (interior bowel lining) abnormalities, known as dysplasia, which can~     progress to CRC. Until recently, IBD surveillance has relied upon colonoscopy with multiple~     (at least 33) random biopsies of the bowel lining to detect dysplasia, but now international~     guidelines recommended a technique called chromoendoscopy.~      Chromoendoscopy involves applying a dye, called indigo-carmine, to the bowel lining whilst~     performing colonoscopy which highlights more subtle abnormalities, therefore increasing~     dysplasia detection rate.~      There is no standard international concentration of the dye spray used during~     chromoendoscopy. Studies have used different concentrations of indigo-carmine dye ranging~     from 0.1 to 0.4%. We have recently shown that 0.2% dye improves detection rates compared to~     high definition white light. The recent international SCENIC guidelines suggest using 0.03%~     indigo-carmine via a foot pump. However there are no trials comparing the two methods and no~     previous trials have used the 0.03%. We therefore aim to perform a randomised control trial,~     comparing 0.03% indigo-carmine dye versus 0.2% in detecting dysplasia in patients undergoing~     surveillance colonoscopy in IBD. Any lesions seen will assessed using standard endoscopic~     appearance but also using optical biopsy forceps to further characterise the lesion, then~     manage the lesion as standard guidelines. We will also take two additional rectal biopsies,~     which will be snap frozen in liquid nitrogen and then studied using Raman Spectroscopy, Infra~     Red spectroscopy and electrochemical impedance to develop optical markers to identify~     patients at higher risk of dysplasia.~   "
24157|NCT03250767|"~     A post market, prospective, non-randomized, multi-center, open-label, clinical study using~     survivorship as the reference performance goal to study the safety and efficacy of the Titan~     Modular Shoulder System 2.5 when used for primary shoulder arthroplasty.~   "
24158|NCT03250754|"~     Headache disorders (HDs), which are characterized by recurrent headache, constitute a~     public-health problem of enormous proportions, with an impact on both the individual sufferer~     and society. The stated goals of long-term headache treatment are to reduce the frequency,~     severity, and disability associated with acute attacks; decrease the reliance on poorly~     tolerated, ineffective, or unwanted acute pharmacotherapies; and avoid acute headache~     medication escalation. There is risk for adverse events, leading some patients to refuse~     prophylactic therapy. Acupuncture is widely used for the treatment of headaches and it may be~     applied as a single modality as well as part of a more complex treatment program. The~     objective of this study will be to investigate whether acupuncture in routine clinical~     practice ((Real World Data) is more effective than treatment of acute migraine attacks or~     routine care only in reducing headache frequency.~   "
24159|NCT03250741|"~     This is phase IIa 24-week, prospective, randomized, double-blind placebo controlled study.~     The study is designed to evaluate the efficacy, safety, and tolerability of transdermal patch~     of Rotigotine (RTG) versus placebo (PLC) as add-on therapy with AChEI in patients with mild~     AD according to the consensus diagnostic criteria and MMSE score of ≥18 and ≤24 at screening.~     Two groups of patients with mild AD will be involved (50 patients each). One group will be~     assigned to treatment with RTG 4 mg and the other one to PLC as add on to AChEI therapy~     (Rivastigmine). Clinical and neurophysiological measurements will be collected before and~     after drug administration.~   "
24160|NCT03250728|"~     The aim of the study is to evaluate the role of the endothelial barrier in the occurrence of~     stroke-like episode. And to study the protein C system on the surface of the endothelium.~   "
24161|NCT03250715|"~     This study aims to verify the effects of low level laser therapy (LLLT) on functional~     capacity, DNA damage, lower limbs muscle strength, quadriceps muscle architecture, muscle~     pain and perception of lower limb fatigue, inflammatory profile, oxidative stress and quality~     of life of patients with chronic kidney failure on hemodialysis. Patients will be randomized~     into two groups: the control group and the LLLT group. The control group will only be~     evaluated and reassessed. The LLLT group in addition to the evaluations will receive LLLT~     three times a week for eight weeks during HD. The evaluations will be performed~     pre-intervention, after 4 and 8 weeks of therapy. However, the muscle architecture evaluation~     will be performed only at pre intervention and after 8 weeks.~      The evaluations carried out are: six-minute walk test for functional capacity; alkaline comet~     assay for DNA damage; sit-and-lift test, and load cell dynamometry for evaluation of lower~     limbs muscle strength; quadriceps ultrasonography for muscle architecture and echogenicity;~     visual analogue scale for pain; subjective perception of effort by Borg scale for fatigue;~     measurement of interleukins 6 and 10, tumor necrosis factor, reative C protein and muscle~     damage markers (lactate, creatine kinase) for the inflammatory profile; protein~     carbonylation, superoxide dismutase, catalase, total sulfuric acid and dichlorofluorescein~     diacetate for oxidative stress and application of the Kidney Disease and~     Quality-of-Life-Short-Form and EQ-5D questionnaires for quality of life.~   "
24162|NCT03250702|"~     The aim of the Dar es Salaam Urban Cohort Hypertension Study (DUCS-HTN) was to determine the~     current prevalence, risk factors, and barriers to diagnosis and treatment for hypertension in~     Dar es Salaam, Tanzania. Few previous studies in Tanzania have analyzed the modifiable~     determinants of high BP as well as barriers to diagnosis and treatment of hypertension.~      DUCS-HTN is a cohort of adults living in the Ukonga ward of Dar es Salaam who had been~     registered in the Dar es Salaam Health and Demographic Surveillance System (HDSS) in 2011.~     Due to the large size of Ukonga, the investigators chose to randomly sample two of the seven~     neighborhoods that compose Ukonga and then conducted a census of these two randomly selected~     neighborhoods, Mwembe Madafu and Markazi. The investigators attempted to contact all 4896~     HDSS participants who were at least 40 years of age and lived in one of these neighborhoods.~      Trained interviewers conducted face-to-face interviews and physical examinations in~     participants' homes from March to June 2014. Follow-up visits were conducted from April to~     June 2015.~      Among 4896 potentially eligible participants from the HDSS baseline survey, 3604 (74%) were~     still living at the same address in 2014. Of these, 2290 (64%) enrolled in the DUCS-HTN~     study. Of the participants enrolled at baseline, 1752 (77%) participated in the follow-up~     study.~      Blood pressure measurements~      Trained interviewers measured blood pressure with digital blood pressure monitors (15 Omron~     M2 and 5 Beurer BM 40 monitors). Standard, large, and extra-large cuff sizes were used~     according to the size of a participant's arm. Blood pressure was measured three times with at~     least a 5-minute rest before the first measurement and 3-minute rests between each subsequent~     measurement. Blood pressure was taken on the left arm with the participant seated and the arm~     straight at heart level. Usual blood pressure values were calculated as the mean of the~     second and third readings. If a second visit was conducted, usual blood pressure values were~     defined as the mean of the second and third readings at both the first and second visits.~      Hypertension was defined as SBP≥140 mmHg or DBP≥90 mmHg, or self-reported use of~     anti-hypertensive medication. Grade I hypertension was defined as SBP of 140 to 159 or DBP of~     90 to 99 mmHg; grade II hypertension was defined as SBP of 160 to 179 or DBP of 100 to 109~     mmHg; and grade III hypertension was defined as SBP≥180 or DBP≥110 mmHg. Hypertension control~     was defined as current antihypertensive use and blood pressure of less than 140/90 mmHg. If a~     participant was found to have grade I or II hypertension, a second visit was scheduled, at~     least three days later. Those with grade III hypertension at the last reading of the first~     visit or grade I or II hypertension at the last reading of the second visit were told that~     they had high blood pressure, advised to see a health professional and were given a referral~     letter. In addition, a second visit and blood pressure reading was scheduled for a random~     sample of one-fifth of participants, who were selected for additional blood, urinary, and~     dietary measurements.~      Assessment of covariates~      All participants were administered a socio-demographic and lifestyle questionnaire and had~     their height, weight, and waist and hip circumference measured. Some demographic information~     (age, sex, neighborhood, religion, and assets used to create a household wealth index) was~     previously recorded during the HDSS baseline. Information on household health insurance~     coverage was collected in 2015 as part of routine HDSS updates.~      Standard protocols were used to take anthropometric measurements. Participants were weighed~     with minimal clothing using a digital scale (Seca, Germany) to the nearest 0.1kg and height~     was measured, with participants not wearing shoes, to the nearest 1cm. Body mass index (BMI)~     was calculated as the ratio of weight in kilograms to height in meters squared (kg/m2) and~     categorized according to WHO categories.~      The Global Physical Activity Questionnaire (GPAQ) was used to assess physical activity for~     work, transportation, and leisure. The investigators defined physical inactivity according to~     WHO guidelines. Number of servings of alcoholic beverages consumed was reported over the past~     30 days. The investigators assumed 14 grams of alcohol as a standard drink portion size. A~     household wealth index was created through a principal component analysis of household~     characteristics and assets, and was categorized into quintiles. In the follow-up visit,~     participants were asked about their health over the past year and the reasons for not seeking~     hypertension care.~      A subsample of ~ one fifth of the participants completed a food frequency questionnaire, two~     24-hour dietary recalls, a 24-hour urine collection for sodium, creatinine, protein, and~     potassium, and had capillary total cholesterol and blood glucose measurements taken.~   "
24188|NCT03250364|"~     Despite different types of bandages are using in the lymphedema treatment, numerous of them~     have not been directly compared. The aim of this study is to compare the efficacy of five~     different kinds of bandages on limb volume and lymphedema-related symptoms. It was also~     measured as secondary variables the comfort of the bandage related by the participants and~     the directly cost of each kind of bandage during the treatment.~   "
24163|NCT03250689|"~     The inflammation associated with COPD is characterized by a prominent infiltration of~     neutrophils in lung tissue and airways. The CXC chemokine receptor type 2 (CXCR2) plays a~     pivotal role in neutrophil recruitment to the lungs resulting in progressive fibrosis, airway~     stenosis, and destruction of the lung parenchyma characteristic of COPD. There is a paucity~     of novel therapies that target these symptoms, and there are no currently available therapies~     that modify disease progression in COPD. Danirixin (GSK1325756) is a selective CXCR2~     antagonist being developed as a potential anti-inflammatory agent for the treatment of COPD~     and influenza. This study is a mechanistic study which aims to evaluate the effect of~     danirixin in reducing neutrophil extracellular traps (NETs) formation (or NETosis). Subjects~     will be randomized (3:1) to receive danirixin hydrobromide (HBr) 35 milligram (mg) orally~     twice daily or matching placebo for 14 days. Subjects may continue to use rescue~     medication(s) and inhaled COPD maintenance medication(s) during the study. The study will~     consist of a screening period of up to 30 days, a 2 week treatment period, and a 1-week~     follow-up visit via phone call. Approximately 50 subjects will be screened to obtain~     approximately 24 subjects to complete the study.~   "
24164|NCT03250676|"~     Phase 1 of the study will be conducted to determine the maximum tolerated dose (MTD) and/or~     the recommended Phase 2 dose (RP2D) of H3B-6545 in women with locally advanced or metastatic~     estrogen receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast~     cancer.~      Phase 2 of the study will be conducted to estimate the efficacy of H3B-6545 in terms of~     response rate, duration of response (DoR), disease control rate (DCR), progression-free~     survival (PFS), and overall survival (OS) in all participants and in participants with and~     without the estrogen receptor alpha (ERα) mutation.~   "
24165|NCT03250663|"~     Patients with mild to moderate atopic dermatitis will be asked to participate in helping the~     study team determine how well the medication works for atopic dermatitis. Participants will~     not be told that adherence will be monitored. Patients will be dispensed topical crisaborole~     2% ointment (Eucrisa®) in a medication tube fitted with a Medication Event Monitoring System~     (MEMS) cap if they agree to participate. This cap records dates and times the bottle is~     opened and this data can be downloaded and tabulated with the associated software.~      Investigators and subjects will be blinded to the adherence data until the final treatment~     (12 month) session. The study subjects will be randomized to two groups. After baseline~     visit, both groups will come for a follow-up visit at 1 month, 3 months, 6 months, and 12~     months. The intervention group will also be asked to complete an online treatment response~     survey designed to improve adherence at weekly intervals for 6 weeks, then monthly~     thereafter.~      The study will consist of a 12-month Treatment Phase. Study subjects will be instructed to~     apply the medication twice daily (morning and evening) to all of their AD lesions. They will~     be instructed to apply the smallest amount of study medication possible that is sufficient to~     cover all lesions. These instructions are standard-of-care for patients with AD.~      Subjects will be asked to bring their medication tubes with them at each visit. At each~     visit, the study coordinator will weigh the medication tube and download the MEMS cap data.~     Disclosure of the adherence monitoring will occur at the 12 month visit (or end of~     treatment), at which time the results of the subject's adherence behavior will be used to~     supply individualized treatment options for each subject (feedback session).~      At each visit, drug tubes will be measured for weight to determine the amount of study~     medication used. This data will be correlated with the extent of BSA involved and the~     response of the disease. The MEMS caps will be downloaded at each visit.~   "
24166|NCT03250650|"~     To evaluate the efficacy of combined transvaginal electrical stimulation (ES) and~     transcutaneous tibial nerve electrical stimulation (TTNS) in the treatment of female~     overactive bladder syndrome (OAB).~   "
24167|NCT03250637|"~     The aim of this study is to investigate the interaction between diet - primary meat and fiber~     - and polymorphisms in Toll-like receptors in relation to risk of colorectal cancer in a~     Danish prospective cohort.~   "
24168|NCT03250624|"~     Exploratory, multi-centric, randomized, vehicle-controlled, investigator-blind, parallel~     group study, involving subjects with chronic lesions of AD to evaluate the local and systemic~     safety of CD5024 0.3% cream over a 6-week treatment period compared to its vehicle.~   "
24169|NCT03250611|"~     The Occipito-Cervical (OC) junction is the most cephalad portion of the spinal axis, with~     anatomical osseous complex that allows significant mobility while maintaining biomechanical~     stability. OC instability is a rare disorder with potentially life-threatening consequences.~     Instability may manifest as disabling pain, cranial nerve dysfunction, paralysis, or even~     sudden death. The most common acute presentation is secondary to major trauma. Other~     pathologic processes that may lead to chronic instability include rheumatoid arthritis,~     infections, tumors, and even congenital malformations; OC fusion in aforementioned cases each~     according is then indicated.~      Stabilization of the OC junction remains a challenge, owing to the regional anatomy and poor~     occipital bone purchase. OC stabilization techniques have undergone continuous refinement.~     Early techniques involving simple posterior only bone grafts demonstrated a high rate of~     failure and have largely been replaced by rigid posterior fixation systems using rods/screws~     or plates, providing superior biomechanical stability and higher rates of fusion. One of the~     very modern modalities of fixation methods is the Occipital Condyle Screw (OCS) as a sole~     cranial anchor; believing that decreasing the length of lever arm of the construct,~     increasing the length of the screw purchase, and decreasing stresses addressed on the rod~     with no need to excessively bend it for the occipital slope may enhance the construct~     rigidity, and leaving a greater clear metal-free area of the occiput for graft contact may~     have a real potential benefits in fusion rates.~   "
24170|NCT03250598|"~     The purpose of this Phase I, single-dose, open-label trial is to evaluate the~     pharmacokinetics, safety, and effect on QTc interval of AG-348 in healthy, adult Japanese and~     Non-Asian subjects. The study plans to evaluate 3 cohorts of a single oral dose of AG-348 in~     Japanese and Non-Asian subjects. Pharmacokinetic sampling will take place serially at~     specified times during conduct of the study.~   "
24171|NCT03250585|"~     Secretory phosholipases A2 (sPLA2) are significantly elevated in the plasma of sickle cell~     disease patients with acute chest syndrome (ACS), and similar enzymes have been measured in~     exhaled breath condensate (EBC), which is collected easily and non-invasively. The~     investigators hypothesize that sPLA2 will be measurable in EBC samples from sickle cell~     patients with acute chest syndrome.~   "
24172|NCT03250572|"~     This study was designed to assess the relation between serum ferritin and hepatic fibrosis in~     patients with NAFLD. It included 83 patients with NAFLD with or without hepatic fibrosis, in~     addition to 30 healthy subjects included as controls. Measurement of serum ferritin and its~     correlation with steatosis and fibrosis was done.~   "
24235|NCT03249753|"~     This study is a single-center, randomized, open, double-cycle and double-cross and~     self-reflection phase Ic clinical trial, to evaluate effect and safety of high fat diet on~     pharmacokinetics of SPH3127 tablets.~      Two panels, each consisting of ten participants (The number of single-sex subjects is not~     less than 1/3 of the total number) will be randomized to A or B groups.~   "
24173|NCT03250559|"~     Percutaneous Nephrolithotomy (PNL) was accepted as a treatment modality for large renal~     stones since 1980. Although radiation exposure during PNL is within the safe limits for~     expert endourologist, the mutagenic hazard is still present especially in pediatric~     population. Therefore, employing an alternative imaging technique during PNL would be of~     added advantage. So, the investigators want to compare the efficacy of ultrasound guided PNL~     with the conventional (fluoroscopy guided) PNL in pediatric population. If ultrasound guided~     PNL was as effective as conventional one, this means that many children could be protected~     from the variable hazards of radiation exposure.~   "
24174|NCT03250546|"~     The primary objective of this study is to compare the 2-year progression free survival~     without acute graft versus host disease (GvHD) (aGvHD) grade III-IV or without moderate or~     severe chronic (cGVHD) after transplant from haploidentical hematopoietic stell cell~     transplant (HSCT) or from an unrelated Human Leukocyte Antigen (HLA)-9/10 mismatched~     unrelated donor (MMUD).~      It will use a Phase II, multicenter, prospective, randomized clinical trial.~      By setting a power of 80% and a type I error rate of 5% for a two-sided log-rank test~     (hypotheses tested: probability of event-free survival at 2 years 50% vs. 30 %), 92 patients~     need to be recruited in each arm, for a total of 184 patients.~   "
24175|NCT03250533|"~     One of the important complications of DM is the diabetic foot that may present ulcers, which~     result from multiple risk factors, being diabetic peripheral neuropathy and ischemia due to~     peripheral vascular disease considered the main causes. In this way, the ulcers of the lower~     extremities of diabetics, have a complex and long cicatrization process. Faced with this, the~     treatment of chronic wounds is challenging, the diversity of treatments is great, however the~     search for new modalities of effective therapeutic resources, scientifically proven and~     financially feasible, that are available and easily accessible for clinical practice is still~     desirable . The aim of this study was to evaluate the responses of phototherapy with light~     emitting diodes (LED) and electrical stimulation with the fixed diphasic current (DF) in~     ulcers of diabetic patients. Diabetic volunteers who present with chronic skin ulcers will~     also be randomized (n = 13) to: Treatment group with LED 620 nm, Treatment group with LED 940~     nm, Treatment group with fixed diphasic current and Control group. Interventions will occur~     three times a week for 12 weeks and evaluations will occur on the 1st, 30th, 60th, and 90th~     day of the intervention, followed by follow-up after 30 days of treatment completion.~   "
24176|NCT03250520|"~     This Protocol is a pilot, clinical interventional study to selected patients between five and~     fourteen years of both sexes, carriers of the diagnosis of glioma brain stem and high grade~     recurrent in the central nervous system tumors, in whom there has been no response to~     conventional-based surgery/radiation/chemotherapy treatment or whose location does not allow~     treatment with conventional measures, and that already have an indication for a neurosurgical~     palliative procedure. It will be a close pharmacovigilance on possible adverse effects~     related to the nanomaterial based on the profile of cisplatin (chemotherapeutic platinum~     derivative), since documented toxicity data are not counted for NPt-Ca. Quality of life will~     be documented with PedsQL Cancer Module© and tumor size by magnetic resonance brain images.~   "
24177|NCT03250507|"~     The goal of this study is to evaluate the effectiveness of different formulations of~     bupivacaine infiltrated into the transversus abdominis plane (TAP) on post-operative pain~     management after open abdominal hysterectomy.~   "
24178|NCT03250494|"~     75 female patients were randomly allocated into one of three equal groups. Group I(GI)~     received Dulox 60 mg orally and 100 ml 0.9% sodium chloride solution (NS) intravenous~     infusion (IVI) over 15 min, group II(GII): received combined Dulox capsule 60 mg orally and~     Dex 0.1mg/kg mixed with 100 ml NS IVI and group III(GIII) received identical placebo~     duloxetine capsule and 100 ml NS IVI as a placebo for Dex, 2 hours preoperatively. Patients`~     vitals, VAS and sedation score were assessed at 30 minutes, 1h, 2 h, 6h and 12h~     postoperatively. Total pethidine requirements, plasma cortisol, PONV and patient`s~     satisfaction were recorded.~   "
24179|NCT03250481|"~     Systematic evaluation of pain, agitation and delirium in ICU-patients is recommended and deep~     sedation should be avoided. Sedation is still monitored with clinical assessments, like RASS.~     The Responsiveness Index (RI) is a recently described method for ICU sedation monitoring. It~     is based on processed frontal EMG and reflects the interaction between a patient's conscious~     state and the intensity and frequency of stimulations during treatment. RI has not been~     randomly compared to RASS to titrate sedation to target at a clinically adequate sedation~     state. In this open randomized controlled pilot study of 32 critically ill, mechanically~     ventilated adult patients, investigators will evaluate the feasibility, safety and efficacy~     of RI based sedation compared to standard RASS based titration of sedation. Investigators~     hypothesize first that RI controlled sedation will be safe and, second that RI controlled~     sedation will associate with increased number of ventilator free days alive in 30 days~     without excess adverse events.~   "
24180|NCT03250468|"~     Research aims:~        1. To determine if participation in a group-based cognitive behavioural therapy~          intervention (CBT-I) intervention results in improved sleep quality.~        2. To determine if participation in a group-based CBT-I intervention results in improved~          cardiovascular disease risk factors, and if the CBT-I intervention moderates that~          relationship.~   "
24181|NCT03250455|"~     VALIDITY is a prospective, open-label, multicenter, randomized controlled trial~     （ClinicalTrials.gov number）. The study was designed to evaluate the value of noninvasive~     anatomic CTA combined with functional CTP for the next clinical decision making and the added~     prognostic value of CTP beyond CTA.~   "
24182|NCT03250442|"~     The purpose of this study is to evaluate how well subjects heal after surgery who receive~     standard dressings or incisional negative pressure wound therapy for non-traumatic amputation~     sites.~   "
24183|NCT03250429|"~     To characterize inflammatory cells in the nose of patients with Chronic Rhinosinusitis (CRS)~     before and after sinus surgery.~   "
24184|NCT03250416|"~     The investigator aimed to manage noninvasive ventilation in patients with hypoxemic~     respiratory failure.~   "
24185|NCT03250403|"~     To evaluate the clinical efficacy and safety of peri-neural platelet rich plasma (PRP)~     injection in the treatment of diabetic peripheral neuropathy compared to traditional medical~     treatment.~   "
24186|NCT03250390|"~     Determination of volatile organic compounds to discriminate patients with lung cancer from~     healthy smokers and non-smokers healthy subjects.~   "
24189|NCT03250351|"~     Objective: to determine nerve mobilization techniques effectiveness at improving shoulder~     mobility and arm sensitive disorders in the early breast cancer postsurgical period with~     axillary lymph node dissection. Design: prospective randomized and single blind trial where~     participants will be randomly allocated into two groups by EPIDAT 3.1 software. Follow-up~     will be conducted through six physical therapy assessments: one before surgery, the second~     one after surgery, the third one post-physical therapy intervention, the fourth one after~     three months, the fifth after six months and, the sixth one after twelve months, and the~     seven one after 24 months. Participants: one hundred and forty women, who are undergoing a~     unilateral breast cancer surgery with axillary lymph node dissection in the Gynaecology and~     Obstetrics Unit from Príncipe de Asturias Hospital. Intervention: Early physical therapy to~     control group and Early physical therapy plus nerve mobilization to intervention group during~     the three following weeks from surgery. Hypothesis: nerve mobilization helps brachial plexus~     sliding among its interface which improves sensitive disorders, pain and functionality of the~     inner arm. Key outcomes: range of motion, pain, sensitive disorder, functionality, quality of~     life.~      Data analysis: quantitative variables through t-student test and qualitative variable though~     Chi test through by Statistical Package for the Social Sciences software.~   "
24190|NCT03250338|"~     This is a randomized, multi-center, double-blind, placebo-controlled study designed to~     evaluate the efficacy of crenolanib administered following salvage chemotherapy,~     consolidation chemotherapy, post bone marrow transplantation and as maintenance in~     relapsed/refractory AML subjects with FLT3 activating mutation.~   "
24191|NCT03250325|"~     The purpose of this study is to evaluate the safety and the efficacy of TBI-1301 for NY-ESO-1~     expressing synovial sarcoma when administered following cyclophosphamide pre-treatment.~   "
24192|NCT03250312|"~     This study intends to understand the effects of osteopathic manipulative treatment (OMT) on~     the expression patterns of 60 immune cell biomarkers in the peripheral blood mononuclear~     cells (PBMC) of each participant, before and after intervention - OMT or seated control. This~     study will utilize participants with a history of low back pain (LBP), and will identify and~     validate those immune cell biomarkers that change in most participants after OMT, by using~     the novel protein subcellular localization (PSL) microarray technology. This study intends to~     uncover the important immune cells affected by OMT techniques, therefore to uncover the~     molecular mechanisms of OMT.~   "
24193|NCT03250299|"~     This phase I trial studies the side effects and best dose of microtubule-targeted agent~     BAL101553 when given together with radiation therapy in treating patients with newly~     diagnosed glioblastoma. Drugs used in chemotherapy, such as microtubule-targeted agent~     BAL101553, work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy~     uses high-energy x-rays to kill tumor cells and shrink tumors. Giving microtubule-targeted~     agent BAL101553 and radiation therapy may work better in treating patients with glioblastoma.~   "
24194|NCT03250286|"~     The aim of this study is to demonstrate that patients with high risk of choledocholithiasis~     who undergo ERCP only for patients with choledocholith in the EUS examination[EUS-ERCP group]~     have less negative outcomes (including false-negative results and procedure-related~     complications) than patients who undergo ERCP in all patients with high risk of~     choledocholithiasis[ERCP group]. The primary outcome is the incidence of negative outcomes~     (including false-negative results and procedure-related complications) in both groups. The~     secondary outcomes included days of hospitalization and diagnostic yield of EUS in the~     diagnosis of choledocholithiasis.~   "
24195|NCT03250273|"~     The proposed study is an open-label, two-arm study of entinostat plus nivolumab in patients~     with unresectable or metastatic CCA or PDAC.~   "
24196|NCT03250260|"~     Most women with breast cancer are able to have an operation to remove the cancer while~     preserving the breast (breast conserving therapy, BCT). Whilst cancer control is the most~     important goal, appearance of the breast after surgery has been shown to affect the quality~     of a woman's life after treatment. This is even more relevant now that most women are~     surviving breast cancer.~      Before surgery, women are prepared for how they will look afterwards by having a discussion~     with the Surgeon or Breast Care Nurse. Sometimes women are shown two dimensional (2D)~     (standard) photographs of other women who had a similar operation. Patients have stated that~     viewing photographs of other patients does not prepare them adequately for their own~     experience of surgery.~      Three dimensional (3D) digital photography is currently being used to predict the appearance~     of the breasts after enlargement surgery using specialist software. The investigators intend~     to use a similar system to simulate a patient's appearance after BCT for cancer. The~     investigators believe that this will lead women to feel better prepared for their surgery,~     reduce stress, and lead to greater satisfaction with their breast after treatment.~      This study invites women undergoing BCT to be assigned at random to one of three groups~     receiving standard care (discussion), a 2D photograph, or the 3D simulation before their~     operation. The investigators will find out whether women feel better prepared for surgery and~     are more satisfied with their outcome if they are shown a simulated image of how their own~     breasts are likely to look.~      By taking 3D photographs of all study patients before and after surgery, a more accurate way~     to predict appearance after surgery will be developed for future patients.~   "
24197|NCT03250247|"~     The purpose of this study is to determine if the use of image-guided, endovascular therapy~     (EVT) is an effective strategy with which to reduce Post Thrombotic Syndrome (PTS) disease~     severity and improve quality of life in patients with established disabling iliac-obstructive~     post thrombotic syndrome (DIO-PTS).~   "
24198|NCT03250234|"~     This investigation will examine the impact of skeletal muscle glycogen stores on skeletal~     muscle and circulating microRNA expression and exogenous carbohydrate oxidation.~      Primary Objective Determine the influence of carbohydrate availability (e.g., glycogen~     depletion and repletion) on skeletal muscle microRNA expression, and if changes in~     circulating microRNA are reflective of changes in skeletal muscle microRNA.~      Secondary Objective Determine how initiation of exercise with adequate or low glycogen stores~     effects exogenous carbohydrate efficiency.~   "
24199|NCT03250221|"~     To elucidate the impact of barbed sutures on robotic myomectomy and laparoscopic myomectomy~   "
24236|NCT03249740|"~     The purpose of this study is to evaluate the safety and efficacy of single and repeated~     intravitreal injections of GB-102 in subjects with neovascular (wet) age-related macular~     degeneration.~   "
24200|NCT03250208|"~     The study will enroll healthy pre-menopausal female volunteers in the community. These~     subjects will act as their own controls. The subjects will collect voided urine and~     peri-urethral swab specimens daily for several months. They will also be asked to collect~     vaginal and peri-rectal swab specimens at various time points. Subjects will document various~     lifestyle variables daily. During the middle of the study, subjects will be randomized to~     probiotic vs placebo. Using bacterial culture and 16S rRNA gene sequencing, the study will~     measure the bacterial populations of several anatomic sites longitudinally: voided urine,~     peri-urethra, vagina, and peri-rectal. The study hypothesizes that oral probiotic usage will~     alter the bacterial populations and ratio of Lactobacillus to E. coli within each of these~     sites. Additionally, the study hypothesizes that the changes within each site will occur~     first in the rectum (i.e. GI tract), followed by the vagina, and then the urethra and~     bladder.~      Using the prospective design of daily sampling and lifestyle variable documentation, the~     study may be able to identify possible influences on microbiome stability within the sampled~     sites. The lifestyle variables recorded include: diet, medication usage, menstruation, sexual~     activity, and alcohol consumption.~      This pilot study will establish the variance of the outcome variables among healthy women and~     confirm the emergence of the probiotic with the recommended dose. With this information,~     future researchers will be able to calculate the power needed for a larger randomized trial.~     This trial would also randomize patients who may be at risk for a UTI to receive a probiotic~     vs placebo. The primary outcome measurement will be the change in the ratio of Lactobacillus~     to E. coli. As a secondary aim, the study will evaluate the incidence of UTI in the patients.~   "
24201|NCT03250195|"~     The aim of the study is to examine the value of the new MRI techniques (spectroscopy and~     DWI), and FDG-PET in prognostication of male infertility.~   "
24202|NCT03250182|"~     This is a Phase I open-label, single center study to assess the PK and safety of BGF MDI~     320/14.4/9.6 µg in subjects with moderate to severe COPD. Pharmacokinetics will be assessed~     following a single dose administration on the first treatment day (Day 1) and will be~     assessed again after 7 days of repeat dosing. This study includes a Screening Period of up to~     28 days and a single Treatment Period of 8 days. A follow-up phone call will be conducted at~     least 5 days but no longer than 7 days after the last dose of study drug.~   "
24203|NCT03250169|"~     Goal is to evaluate the achievement of biological NEDA as demonstrated by a drop in~     neurofilament levels in MS patients commencing Alemtuzumab therapy as part of their MS~     management.~   "
24204|NCT03250156|"~     This project aims to evaluate the effectiveness of mindfulness training (MT) on cognitive and~     psychological factors when incorporated to the duty-day schedule of servicemembers (via~     proctored mindfulness practice). Based on prior literature, it can be hypothesized that the~     benefits of MT on measures of attention, working memory, and psychological well-being will be~     greater for servicemembers who engage in proctored mindfulness practice and receive duty-day~     support compared to servicemembers who practice independently, on their own time, with no~     structured duty day support.~   "
24205|NCT03250143|"~     Fifty six patients of CRU attending the urticaria clinic in the department of Dermatology,~     Venereology and Leprology at the Post Graduate Institute of Medical Education and Research,~     Chandigarh will be recruited in the study calculated by using equivalence analysis assuming~     power of 90%, significance level of 5% and standard deviation of 1 and adjusting 5% of~     expected drop-outs after taking written informed consent. This study is undertaken with an~     intention to treat the patients of chronic refractory urticaria completely. Patients will be~     randomized into two groups A and B using computer generated random number tables, group A~     will receive Cyclosporine and group B will receive Azathioprine; wherein, 28 random single~     and double-digit numbers from 1-56 will be selected before recruitment, and patients coming~     on these numbers will be randomized in a particular group. Random number generation,~     recruitment and randomization, were all done by the same investigator..~   "
24206|NCT03250130|"~     The main objective is to assess the feasibility of an intervention based on medical~     Ericksonian hypnosis as a complementary therapy in patients treated with surgery after a~     diagnosis of breast cancer, followed by an indication of adjuvant chemotherapy and~     radiotherapy~   "
24207|NCT03250117|"~     Subjects stable on L-Dopa and oral ropinirole will have their ropinirole replaced with the~     Ropinirole Implant(s). The Ropinirole Implant was designed using the ProNeura™ implant~     technology where the implant is inserted under the skin. This study will measure how much~     ropinirole is released in the blood during 3 months of treatment, and evaluate the side~     effects of this new formulation.~   "
24208|NCT03250104|"~     Throughout project, the investigators design, evaluate and disseminate infection control and~     antibiotic stewardship (ABS) measures aimed at reducing the incidence of Clostridium~     difficile infection (CDI). The measures will focus on known departments with high incidence~     of CDI, i.e. a) hematology/oncology, b) other departments/wards demonstrating above-average~     infection rates, which were identified throughout previous studies. The infection control~     package will include staff training, hand hygiene programs and disinfection measures.~     Throughout the ABS package, investigators will develop and implement ABS measures~     specifically designed for patients at the highest risk of developing hospital-acquired~     infections, i.e. those treated on hematological/oncological wards. Potentially useful ABS~     actions even in critically ill patients are early reduction of exposure based on~     microbiological results, timely cessation of anti-infective treatment, thoughtful~     implementation of screening measures and biomarkers, defined approaches to patients known to~     be allergic to penicillins, and vigorous enforcement of clinical and microbiological~     diagnosis of infection focus.~      The IC and ABS measures aim at educating and assisting clinical personnel in realizing~     treatments according to official guidelines. There will not be a direct contact between study~     personnel and patient. There will be no direct recruitment of patients.~   "
24209|NCT03250091|"~     The project will aim to identify and determine subgroups of patients with different risks of~     progression to gastric cancer and to assess appropriate follow-up intervals. Implementing~     risk stratification only high risk individuals will be offered and performed endoscopic~     surveillance.~   "
24210|NCT03250078|"~     The main goal of this study is to explore the relationship between new-onset diabetes~     mellitus and a subsequent diagnosis of pancreatic cancer. Magnetic Resonance Imaging and~     Magnetic cholangiopancreatography (MRI/MRCP) will be utilized to screen for early stage~     pancreatic cancer or precursor lesions. Individuals with a strong family history or genetic~     predisposition to pancreatic cancer will also be included. Participants will be asked to~     donate a blood sample at specific intervals for the creation of a bio-bank necessary for the~     development of a blood based screening test for Pancreatic Cancer.~   "
24237|NCT03249727|"~     This study will measure the activity of natural killer (NK) cells using the in vitro~     diagnostic device NK Vue in high risk subjects (Quebec risk categories P3 and P4) scheduled~     for colonoscopy.~   "
24211|NCT03250065|"~     This proposal describes the development of a 'Sensing ET Tube'. This device will replace the~     standard endotracheal (ET) tube used in anaesthesia and in ventilated intensive care patients~     and provide key vital signs monitoring utilising optoelectronic sensors. Continuous~     monitoring of patients' arterial oxygen saturation is essential during surgery, however pulse~     oximeters often misread or fail altogether as a result of peripheral vasoconstriction,~     hypotension or hypovolaemia. The Sensing ET Tube will allow continuous measurement of oxygen~     saturation and other parameters, such as pulse rate, from a single internal site, and will~     reduce the number of surface sensors placed on the skin and the number of electrical~     connections to the patient. The applicants have already developed similar sensor technology~     in the oesophagus and other internal locations. A pilot clinical evaluation of the device~     will be completed in anaesthetised patients undergoing surgery. The project will lead to~     further development of a multi-sensor tracheal platform for comprehensive anaesthesia and~     intensive care monitoring.~   "
24212|NCT03250052|"~     The purpose of this study is to evaluate pharmacokinetic interactions and safety between~     fimasartan and linagliptin in healthy male volunteers.~   "
24213|NCT03250039|"~     This study will investigate the absorption, metabolism and excretion of 14C-PF 04965842 and~     characterize plasma, fecal and urinary radioactivity and identify any metabolites, if~     possible, of 14C PF-04965842 in humans. In addition, this study will provide a better~     understanding of the pharmacokinetic disposition of PF-04965842 by obtaining intravenous (IV)~     clearance and delineating the extent of oral absorption (absolute bioavailability (F) and~     fraction absorbed (Fa)).~   "
24214|NCT03250026|"~     This study aims to evaluate whether a convergence dialogue during sick leave, between the~     employee and the employer, with the Primary Care Centre Rehab Coordinator as discussion~     leader, leads to reduced sick leave time compared to those individuals who only have contact~     with a Care Manager during the period of sick leave. The study will be performed as a~     randomised controlled trial with randomisation at the PCC level where intervention PCCs~     offers a convergence dialogue meeting with the work place representative during sick leave in~     addition to Care Manager contact.~   "
24215|NCT03250013|"~     Single-centre open-label prospective study, enrolling 100 children and adolescents aged 6-17~     years, who receive medication for ADHD of any subtype (presentation). Long-term results are~     evaluated with tests of ADHD symptoms (Qb-test), intellectual ability (Wechsler scales;~     WISC), adaptive functioning (Vineland scale), everyday functioning (Weiss Functional~     Impairment Scale; WIFRS), and quality of life (Child Health and Illness Profile-Child Edition~     Scale; CHIP-CE) during 24 months of ADHD treatment.~   "
24216|NCT03250000|"~     This study investigates the influence of acute exacerbation of chronic obstructive pulmonary~     disease (COPD) on retinal microcirculation, on functional status and also investigates the~     prognostic value of retinal vessel caliber assessment in terms of hospitalization and~     mortality during 2 years of follow-up.~   "
24217|NCT03249987|"~     This piece of research is a single centre, two-way cross over, prospective study to compare~     the outcomes and experience of patients completing a paper bladder diary and an electronic~     version. This project aims to examine whether an electronic bladder diary can improve data~     quality compared to a paper bladder diary. Participants will attend an introduction~     appointment within the Urology Department at Royal Hallamshire Hospital. The participant will~     complete the bladder diaries at home and will then complete a questionnaire at the Royal~     Hallamshire Hospital.~      Patients who are being sent an appointment for urodynamics (standard or video) will be also~     sent a recruitment letter and participant information sheet (PIS), to inform them of the~     study. One week later a member of the study team will phone the patient, to see if they are~     interested in participating in the study and assess the eligibility criteria. If that patient~     is interested and they fulfil the inclusion/exclusion criteria they will be invited to attend~     an introduction appointment. This will be conducted 1-2 weeks prior to the urodynamic test,~     at which point study details will be discussed and written informed consent will be taken.~     The participant will be taught how to use the digital and paper versions of the bladder~     diaries~      Participants will be asked to complete the electronic diary for three days and the paper~     diary for three days. Half of the participants will complete the digital diary first, the~     other half will complete the paper diary first, and this will be done by alternating~     consecutively. Patients will be asked to record the time and volume of voids, any~     incontinence or urgency episodes and sleep-wake times. On the day of their urodynamics~     appointment, patients should return with their electronic and paper diaries~   "
24218|NCT03249974|"~     1. The accuracy of the sensors (Flash vs Enlite glucose monitoring) will be evaluated with~          a standardized breakfast test. Patients receive a standardized breakfast. The usual~          insulin bolus will be administered at breakfast. After breakfast, a venous blood sample~          is taken for 2 hours every 15 minutes to determine the blood sugar. At the same time,~          the glucose value shown by the sensors will be noted. A comparison of the blood glucose~          value with the data recorded by the sensor can evaluate the accuracy of the sensor and~          also estimate the lag-time between the sensor glucose and the venous glucose.~        2. Patient satisfaction will be evaluated using a questionnaire that will be completed~          after the Enlite sensor has been worn for 1 month.~        3. The development of skin reactions will be checked by a short questionnaire, supplemented~          with a picture of possible skin phenomena.~        4. The data recorded by the FreeStyle sensor (average glucose,% above target,% within~          target,% under target, amount of hypoglycemia) in the month prior to sensor switching~          will be compared to the same data recorded by the Enlite sensor during the first month~          of use.~   "
24238|NCT03249714|"~     The study will provide efficacy, safety, tolerability and pharmacokinetics data for~     ofatumumab 20 mg subcutaneous injections every 4 weeks compared with placebo for 24 weeks in~     patients from Japan and the other countries and also provide the extended efficacy, safety,~     tolerability and pharmacokinetics data.~   "
24239|NCT03249701|"~     This study investigates electrical acupoint stimulation (EAS) administered in peri-operation~     for improving postoperative recovery in elder patients, who accept knee arthroplasty. the~     surgery cause to change of stress response, which might be associated with postoperative~     recovery of patient Totally, three groups are created, 1/3 participants receive~     transcutaneous electrical acupoint stimulation, 1/3 participants receive electroacupuncture,~     the rest 1/3 will use sham transcutaneous electrical acupoint stimulation.~   "
24219|NCT03249961|"~     Practice is required to improve your shot in basketball or to play a musical instrument. The~     learning of these motor skills can be further enhanced by non-invasively stimulating regions~     of the brain that control movements with electrical currents. These electric currents can~     strengthen or weaken connections of the brain, which consequently affects a person's ability~     to improve their performance on a skill. Non-invasive brain stimulation (NIBS) is widely~     applied in many disciplines of neuroscience research, and has potential therapeutic~     application. There are two specific types of NIBS that will be used in this research study:~     1) Transcranial Direct Current Stimulation (tDCS), which applies very weak electrical~     currents via two rubber electrodes on the scalp, and 2) Transcranial Magnetic Stimulation~     (TMS), which applies magnetic pulses via a coil against the head, to stimulate regions of the~     brain. Both types of non-invasive brain stimulation (i.e., tDCS, and TMS) are well-tolerated,~     painless, and safe. The application of tDCS to brain regions that control movements,~     concurrently with practice of a skill, results in better skill performance, than practice~     alone with no tDCS. Therefore, in this study, we will be testing different types of brain~     stimulation and different amounts of practice.~   "
24220|NCT03249948|"~     Despite significant advances in resuscitation efforts, there are some patients who remain in~     refractory ventricular fibrillation (VF) during out-of-hospital cardiac arrest. Double~     sequential external defibrillation (DSED) and vector change defibrillation have been proposed~     as a viable option for patients in refractory VF. This pilot cluster randomized trial will~     compare (1) continued resuscitation using standard defibrillation; (2) resuscitation~     involving DSED; or (3) resuscitation involving vector change defibrillation, in patients~     presenting with refractory VF during out-of-hospital cardiac arrest. The results of this~     pilot study will provide critical data for planning a larger, adequately powered multi-site~     randomized controlled trial to clinically evaluate DSED and vector change defibrillation~     compared to standard therapy for patients in refractory VF.~   "
24221|NCT03249935|"~     The proposed study is a single center (with multiple long-term YCFs) treatment trial of the~     CDC-recommended azithromycin regimen (1 gm PO once) for chlamydia in males. This study is~     designed primarily to determine the frequency of chlamydia treatment failure following~     azithromycin in males who do versus do not have urethral symptoms of urethral discharge~     and/or dysuria. Anticipated enrollment is 446 males, between the age of 12 to 21 years old,~     with subject participation duration of 28 days and study duration of 4 years. The primary~     objective of the study is to assess the microbiological efficacy of azithromycin in~     uncomplicated Chlamydia trachomatis infection in males with versus without urethral symptoms~     in YCFs.~   "
24222|NCT03249922|"~     The investigators will be evaluating quality of life outcomes in patients who are undergoing~     routine spinal cord stimulator implant for uncontrolled pain. Patients will be evaluated pre~     and post-operatively for quality of life improvements, pain control, and functionality.~   "
24223|NCT03249909|"~     Investigate impact of gelling fiber dressings on handling exudate in medium to high exuding~     wounds~   "
24224|NCT03249896|"~     Gestational diabetes mellitus (GDM) affects one fifth of Singaporean pregnancies and can~     result in short and long term complications for mother and child. Mobile applications are~     effective in improving diabetes care and weight related behaviors through improved~     self-management. A multidisciplinary healthcare team from National University Hospital,~     Singapore has worked with Jana Care to develop the Habits-GDM smartphone app, a lifestyle~     coaching program specific for gestational diabetes. It consists of interactive lessons to~     provide patient education, diet, activity and weight tracking tools, messaging platform for~     coaching and motivating patients towards healthy behavior beneficial for gestational~     diabetes. It interfaces with the Aina device, a novel hardware sensor that plugs into any~     smartphone and can be used for glucose monitoring. This study aims to test the effectiveness~     of this app in preventing excessive weight gain in pregnancy among patients with gestational~     diabetes.~   "
24225|NCT03249883|"~     The purpose of this study is to determine whether the geriatric prosthetic foot 1M10 is~     superior to the classical SACH (Solid Ankle Cushion Heel) foot, when used by indoor~     ambulators with a transtibial amputation.~   "
24226|NCT03249870|"~     The aim of the present EWALL-INO study is to confirm very promising results obtained with a~     combination of INO and mild chemotherapy in older de novo CD22+ B-ALL patients. For that~     purpose, safety and efficacy of a weekly INO administration combined to mild-intensity~     chemotherapy will be evaluated in a cohort of patients aged more than 55 years with newly~     diagnosed previously untreated Ph-negative (CD22+) BCP-ALL. Conversely to the MDACC~     miniHCVD-INO study and in order to lower the overall toxicity of the combination, INO will be~     given as part of the remission induction treatment phase during the first 2 treatment cycles~     only, in combination with corticosteroid, vincristine, cyclophosphamide and intrathecal~     prophylaxis only; then, all responding patients will received standard INO-free chemotherapy~     as consolidation and maintenance.~   "
24227|NCT03249857|"~     Based in an embodied approach of cognition, several studies have highlighted a direct link~     between perception of an object or an emotion and the associated motor responses. This study~     investigated in patients suffering from bipolar affective disorders whether the perception of~     emotional words involves an automatic sensorimotor simulation of approach and avoidance~     behaviors, and whether the perception of an object involves an automatic sensorimotor~     simulation of object prehension (affordance). We hypothesize that, in this pathology, low~     level (sensorimotor) cognitive processes are preserved whereas high-level (attentional) are~     altered. 20 patients suffering from bipolar affective disorders and 20 healthy controls will~     be recruited. The main objective is the emergence of sensorimotor compatibility effects in~     approach-avoidance task with emotional stimuli (gain between compatible vs incompatible~     conditions).~   "
24240|NCT03249688|"~     The main aim of the MIND-ADmini pilot trial is to evaluate the feasibility of a multimodal~     lifestyle intervention among patients with prodromal AD.~   "
24265|NCT03249363|"~     The purpose of this study was to evaluate the efficacy, in preventing Spinal Surgical~     Infection, of intraoperative pulsatile irrigation with a 2000-ml saline solution of~     PVP-Iodine in a group of patients undergoing complex spine surgery with a posterior approach.~     To confirm and better assess the efficacy of intraoperative irrigation on the infection rate~     in spinal surgery, specimens for bacterial culture were harvested by swabs from muscular~     tissue before and after irrigation of the wounds~   "
24228|NCT03249844|"~     Arterial ischemic stroke (AIS) is a devastating condition, affecting 1.6-5/100,000~     children/year. Although their outcome is different, children with stroke do not recover~     better than adults, with at least 2/3 suffering long term sequels such as developmental~     (motor, global intellectual, language...) and behavioral disabilities, epilepsy, and low~     adaptative and academic skills...~      Stenotic cerebral arteriopathy is identified as AIS etiology in 60-80% of previously healthy~     children and the course of this arteriopathy is the strongest predictor of recurrent events.~     30-40% of these children have a focal unilateral cerebral arteriopathy (FCA). Childhood FCA~     is suspected to be an inflammatory vessel wall pathology triggered by varicella and other~     (viral) infections. As recurrences occur for the great majority in the first 6 months after~     the index event, aspirin 5 mg/kg/day is recommended for at least 18 months to 2 years.~      As there is a rational for using immunomodulatory drugs at the acute stage of FCA,~     immunotherapies are currently used by neuropaediatricians in AIS, mainly as steroids for~     children with stenosing arteriopathies. However, due to weak evidences, the literature cannot~     either encourage or discourage this practice.~      The long term course of children with FCA is only approach to date by retrospective studies~     and controversies about outcome remain (for example, the recurrence risk on antithrombotic~     treatment varies notably from quasi zero to 25%). And finally, it is shown in childhood~     stroke, as well as in the global field of longstanding impairment, that parental and medical~     points of view do not match consistently. Longitudinal studies are needed to deserve this~     familial approach.~   "
24229|NCT03249831|"~     Blood stem cells can produce red blood cells (which carry oxygen), white blood cells of the~     immune system (which fight infections) and platelets (which help the blood clot).~      Patients with sickle cell disease produce abnormal red blood cells. A blood stem cell~     transplant from a donor is a treatment option for patients with severe sickle cell disease.~     The donor can be healthy or have the sickle cell trait. The blood stem cell transplant will~     be given to the patient as an intravenous infusion (IV). The donor blood stem cells will then~     make normal red blood cells ─ as well as other types of blood cells ─ in the patient. When~     blood cells from two people co-exist in the patient, this is called mixed chimerism.~      Most children are successfully treated with blood stem cells from a sibling (brother/sister)~     who completely shares their tissue type (full-matched donor). However, transplant is not an~     option for patients who (1) have serious medical problems, and/or (2) do not have a~     full-matched donor. Most patients will have a relative who shares half of their tissue type~     (e.g. parent, child, and brother/sister) and can be a donor (half-matched or haploidentical~     donor).~      Adult patients with severe sickle cell disease were successfully treated with a half-matched~     transplant in a clinical study. Researchers would like to make half-matched transplant an~     option for more patients by (1) improving transplant success and (2) reducing~     transplanted-related complications.~      This research transplant is being tested in this Pilot study for the first time. It is~     different from a standard transplant because:~        1. Half-matched related donors will be used, and~        2. A new combination of drugs (chemotherapy) that does not completely wipe out the bone~          marrow cells (non-myeloablative treatment) will be used to prepare the patient for~          transplant, and~        3. Most of the donor CD4+ T cells (a type of immune cells) will be removed (depleted)~          before giving the blood stem cell transplant to the patient to improve transplant~          outcomes.~      It is hoped that the research transplant:~        1. Will reverse sickle cell disease and improve patient quality of life,~        2. Will reduce side effects and help the patient recover faster from the transplant,~        3. Help the patient keep the transplant longer and~        4. Reduce serious transplant-related complications.~   "
24230|NCT03249818|"~     The purpose of this research study is to collect data from the eyes of traumatic brain injury~     (TBI) patients. Patients will look at a green target that will measure the fixation of the~     eye for 30 seconds. In that 30 seconds, the location of the green target will change and the~     participant is to track, with their eyes, the light as best they can. The device will measure~     how well fixation was maintained and the speed of the saccadic movements of the eye. Data~     will then be used to determine whether there is correlation between these measures and known~     TBI.~   "
24231|NCT03249805|"~     The aim of this study is to determine the effect of a new design of FAB type on compliance~     and treatment outcomes of idiopathic clubfeet treated by the Ponseti method. Very little~     literature exists on the effect of brace type or the difference between reported and actual~     at-home compliance, which is integral to the success of treatment with the Ponseti method.~     Eighty children less than 1 year of age will be enrolled in the study into two arms, using~     block randomization. These two groups will use two different designs of foot abduction brace~     (FAB). Outcomes will be measured by number of recurrences per group (using recasting and/or~     surgical procedures and Pirani score as indicators), time of recurrences (in months),~     compliance with brace wear using sensors and comparing the data with brace wear reported by~     parents, and parent satisfaction with FAB (measured on a modified Orthotics and Prosthetics~     User Sur vey). Enrollment will be on a rolling basis; subjects will be enrolled at their last~     cast application and followed for approximately 6 months. Recurrences, time of recurrence,~     parent satisfaction, and reported vs. actual compliance will be analyzed.~   "
24232|NCT03249792|"~     The purposes of this study are to: 1) assess the safety and tolerability and 2) establish a~     preliminary recommended Phase 2 dose (RP2D) and/or a maximum tolerated dose (MTD) or a~     maximum administered dose (MAD) of MK-2118 when administered via intratumoral (IT) injection~     as monotherapy and in combination with pembrolizumab (MK-3475) intravenous (IV) infusion and~     via subcutaneous (SC) injection in combination with pembrolizumab IV infusion in the~     treatment of adult participants with advanced/metastatic solid tumors or lymphomas.~   "
24233|NCT03249779|"~     To evaluate, in a pilot fashion, efficacy and tolerability of electrical counter-stimulation~     using the Scrambler device in alleviating uncomfortable sensations and urge to move in~     patients with restless legs syndrome/Willis Ekbom Disease (RLS/WED).~   "
24234|NCT03249766|"~     Thoracic surgeries are associated with significant operative trauma1. While thoracic epidural~     analgesia may help control the incisional component of the pain, an excruciating~     postthoracotomy. Ipsilateral Shoulder Pain (ISP) could under mine pain management in the post~     thoracotomy patient2. The incidence of ISP ranges from 21% to 97%3. ISP impairs respiration,~     mobility, and physical therapy in the early postoperative period4. The etiology of ISP is~     unclear. Several hypotheses have been proposed as possible causes of ISP, including~     transection of a major bronchus, ligament distraction by surgical retraction, shoulder joint~     strain as a result of intraoperative positioning, pleural irritation due to the thoracostomy~     tube, and referred pain from irritation of the pericardium or mediastinal and diaphragmatic~     surfaces2, 5, 6. ISP is defined as the pain occurring on the operated side of thoracic~     surgeries in the immediate postoperative period as early as one hour after surgery6,of dull~     aching, stabbing, burning, electric or throbbing nature of moderate to severe intensity and~     resistant to treatment, most commonly located in the region of the deltoid muscle or on the~     posterior or superior surface of the arm or above ⅓ of the lateral part of the clavicle on~     the anterior surface of the chest, lasting 3-4 days2, 7-11.The primary objective of this~     study is to find out the prevalence of ISP and the risk factors associated with it.~   "
27607|NCT03205618|"~     The study will provide safety and efficacy information among patients receiving daclatasvir.~     It will describe daclatasvir prescribing patterns and provide a clinical profile of patients~     receiving the treatment in KSA, UAE, and Qatar.~   "
24241|NCT03249675|"~     Concussion is widely recognized as a major public health concern in the United States and~     worldwide. Although many concussions resolve completely and spontaneously, almost 1 in 4~     patients will go on to experience post-concussion syndrome (PCS). In the United States, PCS~     diagnoses have increased 100% from 2010-2015. Concurrently, recent advances in EEG evoked~     response potential analysis have led to a novel technique for assessing brain network~     activation (BNA) patterns. The purpose of this study is to explore the use of BNA in~     individuals who are diagnosed with PCS or have the risk of experiencing PCS due to a recent~     injury.~   "
24242|NCT03249662|"~     To study efficacy of postoperative pain control of different concentrations of bupivacaine~     for periarticular infiltration, part of multimodal analgesia, in bilateral total knee~     arthroplasty.~      To study plasma concentration of bupivacaine in patient who received spinal anesthesia and~     single shot bilateral adductor canal block and periarticular infiltration with bupivacaine~     for safety level.~   "
24243|NCT03249649|"~     The focus of this project is to elucidate the gaps in care and enhance the provision of~     FGC-related health care and social services for women in Arizona who have experienced FGC;~     engaging the Somali and Somali Bantu communities. As of 2012, Arizona ranked 7th in the US~     for Somali refugee resettlement. The Refugee Women's Health Clinic (RWHC) is a nationally~     recognized best practice model for refugee women's health, providing specialized care for~     women with FGC. The project will accomplish four outcomes throughout its three-year duration:~     1: Identify specific FGC-related health care needs and available health and social services~     for women in Arizona who have experienced FGC to improve services to FGC-affected~     communities; 2: Identify gaps, barriers, and/or assets in FGC-related health care and social~     services for women in Arizona who have experienced FGC to provide improved services to~     FGC-affected communities; 3: Create and implement FGC education efforts so that providers~     improve culturally competent care for women who have experienced FGC in health care and~     social service settings; and, 4: Create and implement community outreach and educational~     programs among communities affected by FGC to increase awareness of FGC-related health~     issues, prevention and services available. To inform these initiatives, an established~     infrastructure exists through the Refugee Women's Health Community Advisory Coalition~     (RWHCAC), a team of more than 60 stakeholders from various local ethnic organizations,~     refugee resettlement and voluntary agencies, mental health and social services agencies, and~     academic partners and including local voluntary resettlement agencies (VOLAGs) and Ethnic~     Community-Based Organizations (ECBOs). RWHCAC will be (a) involved in the planning/design of~     the project, (b) encouraged to assume responsibility to identify additional Community~     Mobilizers, (c) engaged in aligning educational material content to cultural standards, and~     (d) engaged in evaluating the project processes and outcomes.~      Project strategies include: (1) identifying specific FGC-related health care needs and~     available health and social services for FGC-affected women including identification of gaps,~     barriers, and/or assets in FGC-related care (year 1); (2) utilizing results from the~     Community Health Needs Assessment (CHNA) to refine existing educational materials and~     implement educational outreach efforts across the state to improve culturally competent care~     among providers (years 2 and 3); (3) promoting outreach and education among FGC-affected~     communities through development of culturally appropriate materials and community education~     sessions (years two and three); and, (4) partnering with Arizona Department of Health~     Services, the University of Arizona, and African Women's Health Center, Brigham and Women's~     Hospital during year 2 to deliver inter-professional training workshops for health and social~     service providers on FGC, and with Johns Hopkins University for FGC teleECHO™ video~     conferencing clinics to promote sustainability via links to online resources, educational~     materials, and webinars (years 2 and 3). Emergent products include online learning~     components, community education sessions, FGC teleECHO™ sessions, and capacity building~     trainings for all partners.~   "
24244|NCT03249636|"~     Acute lymphoblastic leukemia , also known as acute lymphocytic leukemia, characterized by the~     overproduction and accumulation of cancerous, immature white blood cells, known as~     lymphoblasts, causing damage and death by inhibiting the production of normal cells (such as~     red and white blood cells and platelets) in the bone marrow and by spreading (infiltrating)~     to other organs. Acute lymphoblastic leukemia is most common in childhood, with a peak~     incidence at 2-5 years of age and another peak in old age.~   "
24245|NCT03249623|"~     Patients residing in the intensive care unit typically receive mechanical ventilatory~     support. Selecting the appropriate level of mechanical ventilation is not trivial, and it has~     been shown that lung protective settings can reduce mortality in patients with lung injury.~     Despite being a life- saving therapy, duration of mechanical ventilation should be kept at a~     minimum to reduce effects of immobilization, long-term sedation, patient discomfort, risk of~     ventilator associated pneumonia, leading to decreasing mortality and economic costs etc. The~     duration of mechanical ventilation is also an important factor in weaning from ventilatory~     support, with prolonged ventilator support making the weaning process more difficult.~      The purpose of this study is to compare mechanical ventilation following advice from the~     Beacon Caresystem to that of standard care in general medical intensive care unit (ICU)~     patients, from the start of requiring invasive mechanical ventilation until successful~     extubation. The Beacon Caresystem will be compared to standard care to investigate whether~     use of the system results in similar care or reduced time for weaning from mechanical~     ventilation.~   "
24246|NCT03249610|"~     Impact of lifestyle intervention in at-risk Asian Indians at worksite remains largely~     unexplored. The aim of this study was to assess impact of the multi-component interventions~     on body weight, body fat patterning and cardio-metabolic risk factors in overweight~     individuals working in corporate worksites in New Delhi, north India.~   "
24247|NCT03249597|"~     Sepsis is a condition with a high mortality. Septic patients are frequently difficult to~     identify because of their non-specific presentations. There is also a low sensitivity of~     clinical judgment among health care personnel, and of existing screening tools, which are in~     turn typically based on vital parameters. Despite prior research, no unique sepsis biomarker~     has been identified so far.~      There is a need for new strategies to identify sepsis which do not rely on vital parameters~     and traditional laboratory blood tests alone. The hypothesis of the investigators is that a~     combination of clinical variables measurable in the ambulance can be used to predict sepsis.~      The aim of the current study is to determine the predictive value of keywords related to~     symptom presentation, vital parameters and point-of-care (POC) blood tests, alone and in~     combination, with respect to the outcome sepsis.~      The study is performed in the Stockholm ambulance setting from April 2017. A total of 648~     adult non-trauma patients will be included.~   "
24248|NCT03249584|"~     This study evaluates the effectiveness of the Medtronic OsteoCool™ RF Ablation System.~   "
24261|NCT03249415|"~     Infertility, which affected 48.5 million couples worldwide in 2010 alone, has many causes;~     some causes result from issues related to the endometrium. Unfortunately, no cure exists for~     medical conditions resulting in the destruction of the endometrium, or for non-functional~     uterus. Thus, safe and effective therapies are needed to treat these diseases and to~     establish fertility in affected women. These novel techniques refer to the use and~     application of regenerative/paracrine factors to regenerate the endometrium in patients with~     Asherman's Syndrome (AS) and Endometrial Atrophy (EA).These new therapies based on the~     injection of the identified regenerative/paracrine factors and the platelet-rich plasma (PRP)~     from whole blood in an immunodeficient mouse model with AS/EA, evaluating their contribution~     and/or effect in the endometrial repair by functional proofs.~   "
24262|NCT03249402|"~     The purpose of this study is to evaluate the effect of multiple 40 milligram (mg) doses of~     JNJ-42847922 on the steady state pharmacokinetics (PK) of multiple doses of a combination~     oral contraceptive (OC) containing ethinyl estradiol (EE) and levonorgestrel (LN) in healthy~     female adult partcipants.~   "
24249|NCT03249571|"~     PURPOSE:~        1. PRIMARY: Using a randomized, parallel group design, this investigation will determine if~          the combination of 2-weeks polyphenol supplementation (using the Reoxcyn flavonoid~          supplement in capsule form) and one acute 45-minute brisk walking bout enhances the~          translocation of gut-derived phenolics into the circulation. A comparator group of~          runners (N=20) ingesting the flavonoid supplement for two weeks will be included (2.5 h~          run, 70% VO2max).~        2. SECONDARY: Data from this study will determine if 2-weeks supplementation of the Reoxcyn~          flavonoid supplement is a sufficient time period to increase circulating levels of~          gut-derived phenolics, extending data collected from the previous 12-week community~          trial.~      HYPOTHESIS: We hypothesize that an acute 45-minute brisk walking exercise bout (60% VO2max)~     following 2 weeks of increased polyphenol intake will be a sufficient exercise stimulus to~     increase gut permeability and the movement of gut-derived phenolics into circulation. If this~     hypothesis is confirmed, these data would have broad public health appeal, demonstrating that~     the combination of brisk walking and increased polyphenol intake augments circulating levels~     of health-restoring small phenolic molecules derived from bacterial breakdown in the colon.~   "
24250|NCT03249558|"~     A double-blind, randomized, and placebo-controlled clinical study examining whether~     duloxetine, a serotonin and norepinephrine reuptake inhibitor (SNRI), could enhance opioid~     analgesia and reduce overall opioid use. Positive outcomes will help improve the overall~     effectiveness of clinical opioid therapy and reduce unnecessary opioid dose escalation.~   "
24251|NCT03249545|"~     Premature Ventricular Complex (PVC) ablation is performed in certain indications. Generally~     acutely abolition of PVC at the time of ablation accepted as successful ablation. However in~     some patients this effect occurs lately. In this study investigators sought late effect of~     ablation~   "
24252|NCT03249532|"~     Online hemodiafiltration confers a reduced mortality risk. However, it is not clear why HDF~     improved survival. To gain more insight in this issue, the effect of 4 dialysis techniques~     (differing in dialysate temperature and the absence/presence of convective clearance) on~     intradialytic hemodynamic stability and cardiac function will be investigated in a~     prospective cross over trial.~   "
24253|NCT03249519|"~     The combination of radiation therapy or chemoradiation with Interstitial brachytherapy for~     advanced cervical cancer (pN+, FIGO-Stage II B - IV A is standard of therapy. The radio- and~     chemosensitive effect of an additional hyperthermia might improve the clinical outcome.~   "
24254|NCT03249506|"~     The purpose of this study is to identify and evaluate the event rate of the composite~     endpoint of all-cause mortality (ACM) or hospitalization for heart failure (HF) for~     participants with Type 2 Diabetes mellitus (T2DM) and established cardiovascular (CV) disease~     among new users of sodium-glucose co-transporter 2 inhibitor (SGLT2i) as compared with new~     users of non-SGLT2i anti-hyperglycemic agent (AHA).~   "
24255|NCT03249493|"~     As of today, HIV-infected patients followed in decentralized area have little or even no~     access to viral load monitoring because laboratories able to perform this biological~     measurement are only in large cities, and because plasma transfer to these laboratories is~     complex and very costly.~      Blood sampling using dried blood spots (DBS) could overcome these difficulties. The goal of~     this operational research is to document the feasibility of DBS use in decentralised area to~     monitor viral load, to evaluate the virological response on ART, and to compare the~     virological response between injecting drug users (IDU) and the other patients, as IDU~     represent a large proportion of HIV-infected patients who may have a lower access/adherence~     to care.~   "
24256|NCT03249480|"~     To Evaluate the safety and efficacy of PEG Somatropin in the treatment of children with~     growth hormone deficiency, as well as to study the dosage of PEG Somatropin.~   "
24257|NCT03249467|"~     The purpose of the study is to develop a validated French version of the HAQ-II questionnaire~     for rheumatoid arthritis.~   "
24258|NCT03249454|"~     The purpose of the study is to investigate the effects of a novel therapeutic approach with~     transcutaneous spinal direct current stimulation (tsDCS) to promote functional recovery and~     spasticity in chronic spinal cord injury (SCI).~   "
24259|NCT03249441|"~     This study aims to explore the effectiveness of a group psychotherapy intervention using~     Compassion-Focused Therapy (CFT) in adults with severe obesity. In particular, it aims to~     evaluate the principle that CFT can be used to reduce levels of shame and self-criticism in~     adults with severe obesity~      OBJECTIVES:~      The objective of the current study is to assess and compare a CFT group intervention to~     Treatment as Usual (TAU) with regard to psychological functioning, specifically~     self-compassion, shame, self-criticism, emotional eating and mood.~   "
24260|NCT03249428|"~     Tobacco is the most preventable cause of disease and death in Canada. Although the tobacco~     use rate has substantially gone down in the general population, significant differences exist~     between sub-populations in Canada, for example Ottawa's highly vulnerable homeless or at-risk~     for homelessness population has an almost 100% tobacco smoking rate relative to 9-18% in the~     rest of the Canadian general population. This stark inequity in tobacco use translates into~     devastating healthcare outcomes such as a disproportionate amount of cancer, stroke, heart~     disease and death. Canadians who are homeless or at-risk for homelessness die 25 years~     earlier than housed Canadians, mostly due to tobacco. In order to tackle this tobacco use~     related inequity - a novel approach is urgently needed. Despite commonly held dogma that~     People Who Use Drugs (PWUD) don't want to quit smoking, many studies have demonstrated that~     in fact they are very interested in quitting. Moreover, the investigators pragmatic peer-led~     community-based action approach used in their PROMPT project has demonstrated that tobacco~     dependence strategies can be implemented with great success in this population. The majority~     of PROMPT participants reduced or quit tobacco use, in addition to reducing or quitting all~     other drug use. Importantly, the investigators have demonstrated that it is possible to gain~     the trust and engagement of marginalized populations and that researchers can create a~     community space that is low-threshold, safe and non-judgmental. The investigators aim to~     compare two tobacco dependence management strategies in the homeless (or at-risk for~     homelessness) multi-drug use population in Ottawa and Toronto. They will use the same~     peer-led approach in PROMPT with community peer researchers with lived experience; with the~     hope that the cost-effective community based framework derived from this trial will serve as~     a template for interventions and treatments in community settings for chronic diseases such~     as obesity and diabetes.~   "
24263|NCT03249389|"~     This study is to Assess hypercalciuria between J1 of the cure and 1 J1 6 of the cure of~     adjuvant chemotherapy in patients receiving conventional adjuvant chemotherapy of breast~     cancer.~   "
24264|NCT03249376|"~     The study will evaluate the efficacy and safety of ITI-007 in a randomized, double-blind,~     parallel-group, placebo-controlled, multi-center study in patients diagnosed with Bipolar I~     or Bipolar II disorder having a major depressive episode.~   "
27608|NCT03205605|"~     This research study is intended to determine the effect of heat on oxybutynin products.~   "
24266|NCT03249350|"~     The ultimate goal of this research is to facilitate rapid enhancement of youth substance~     abuse treatments by determining the key mechanisms of change (i.e., what to target more~     intensely to generate better outcomes). This work is critical because current outpatient~     adolescent substance abuse treatments yield only small to medium effects that diminish once~     treatment has ended. The proposed modern mediation study will address this serious public~     health problem by experimentally evaluating the most critical factors causing change in~     client outcomes during adolescent substance abuse treatment, directing the field to focus~     treatment efforts on those factors.~   "
24267|NCT03249337|"~     In brief, the objective of this study is to investigate whether the drug Glanatec ® which is~     approved in Japan for glaucoma and ocular hypertension, can be used in patients with Fuchs~     endothelial dystrophy who have had a descemet stripping procedure without endothelial~     keratoplasty. While some limited data exists as a proof of concept in in vitro or animal~     studies, and Glanatec® has been successfully used in a recently published case series for~     this indication, there is insufficient data to show that this drug can be effectively used~     for corneal cell clearing while maintaining patient safety.~      The goal of the study is to provide sufficient proof of concept for the use of this drug in~     patients with FED whose only treatment alternative is to undergo corneal transplant.~   "
24268|NCT03249324|"~     Women with pre-pregnancy obesity, women who exceed recommended weight gain during pregnancy,~     and children who experience rapid and excess growth during the first year of life are all at~     risk for subsequent obesity. The purpose of this study is to examine creative cognitive~     strategies to promote healthy weight gain during pregnancy, creating a sound substrate of~     metabolic programming for the critical first six months of life. A trans-disciplinary~     approach utilizing a patient- and family-centered intervention and active patient engagement~     with counseling for positive gain will work with women to shape lifestyle during pregnancy~     and postpartum, and when feeding their infants in the first 6 months of life. It is~     hypothesized patient engagement with counseling for positive gains will successfully mitigate~     excess weight gain in both pregnancy and infancy compared to usual care. Moreover, data will~     be examined to assess whether psychological variables, work and school climate, and social~     support factors influence body weight gain trajectories and/or weight loss during and after~     pregnancy.~   "
24269|NCT03249311|"~     Levomilnacipran is an antidepressant currently approved in Canada to treat Major Depressive~     Disorder (MDD). Thirty-six healthy male participants will receive escalating doses of~     levomilnacipran, duloxetine, or placebo every 7 days (+/- 1 day) throughout a 20 - 28 day~     period. After each dose escalation study participants will be asked to come to the clinic to~     conduct the necessary tests - these will include tyramine pressor tests as well as blood~     draws. The results of this study will allow the investigators to determine the dose(s) of~     levomilnacipran at which reuptake inhibition of norepinephrine and serotonin (chemicals~     utilized by nerve cells to transmit information to other cells) is achieved.~   "
24270|NCT03249298|"~     Fluid optimization in neurosurgical patients has an important impact on preservation of~     cerebral perfusion pressure and minimization of cerebral oedema during and after the~     craniotomy. The investigators would like to know if crystalloids or colloids are equally~     useful for goal directed therapy in this patients. The investigators will record haemodynamic~     stability, volume loading and postoperative complications and compare two groups of patients.~     One group will be optimised with crystalloids and the second with colloids. The investigators~     will compare also hospital stay and mortality in the two groups.~   "
24271|NCT03249285|"~     This is a pharmacogenomic prospective , four-arms, parallel groups, active comparator~     controlled study in essential hypertensive patients never treated before.~      Each patient will be genotyped for SNPs (single nucleotide polymorphism) in preliminary~     genetic profiles and will be treated according to their genetic profile with Peri~     (Perindopril) 4 mg or HCTZ ( hydrochlorothiazide) 12.5 mg.~   "
24272|NCT03249272|"~     The aim of this study is to assess microvascular function as determined by a cardiovascular~     magnetic resonance measurement of whole-heart (global) perfusion reserve. The goal is to~     determine the prevalence of MVD in two common forms of non-ischemic cardiomyopathy,~     hypertrophic cardiomyopathy (HCM) and idiopathic dilated cardiomyopathy (IDCM). The~     hypothesis that an optimized technique will provide robust detection of MVD and that a~     multifaceted approach will provide new insights into the pathophysiology of MVD, including~     the influence of myocardial scarring upon the presence and severity of MVD.~   "
24273|NCT03249259|"~     In this study, the investigators are going to investigate the efficacy of choline alfoscerate~     on improvement of cognitive function assessed by MMSE compared to plaebo.~   "
24274|NCT03249246|"~     The prevalence and mortality of sepsis in Turkey is not know at large. Turkish Society of~     Intensive Care Medicine, Sepsis Study Group conducted a multi-centre,point prevalence survey~     to determine the prevalence, causative micro-organisms and outcome of sepsis in Turkish ICUs.~   "
24275|NCT03249233|"~     The purpose of this study is to investigate changes in the corneal thickness of scleral~     contact lens wearers in a keratoconic (KC) population and compare to age-matched controls.~     The hypothesis is that scleral contact lens wear is associated with low levels of corneal~     hypoxia including measurable changes in corneal thickness. Corneal thickness will be altered~     post scleral lens wear compared to pre-lens wear and the amount of alteration will correlate~     to the fitting characteristics in the central zone of the scleral lenses. We propose to take~     a sample of keratoconic and control participants, fit them in scleral lenses, and to measure~     topographic corneal thickness after 8-10 hours of scleral lens wear after two weeks of wear,~     to compare two instruments in the measurement of corneal thickness, and to compare the~     effects of varying central corneal clearance of the scleral lens on corneal thickness.~   "
24276|NCT03249220|"~     Clinical pilot study to evaluate a new multi-parameter neuromonitoring device that allows the~     measurement of regional cerebral blood flow (rCBF), intracranial pressure (ICP), brain~     temperature monitoring and ventricular cerebrospinal fluid (CSF) drainage in brain-injured~     patients.~   "
24369|NCT03248011|"~     The purpose of the current study is, 1) Determine the effectiveness of injury prevention~     programs for prevention of hamstring muscle strains, 2) Identify how these programs impact~     athletes' flexibility, muscle stiffness, strength, and power, and 3) Determine the ability of~     a state-of-the-art imaging technology, shear wave elastography to predict future hamstring~     muscle strain injury.~   "
24277|NCT03249207|"~     This phase III trial will establish whether IL-1Ra, with sub-cutaneous (SC) administration~     twice daily for up to 21 days post aneurysmal subarachnoid haemorrhage (aSAH), improves~     clinical outcome as measured by ordinal shift in mRS at 6 months.~      Patients with SAH transferred to a neurosurgical centre will be identified and approached for~     study participation. Following consent, patients will be randomised to receive either IL-1Ra~     or placebo for a maximum of 21 days from onset of symptoms. Patients who are found to be~     non-aneurysmal following randomisation will be withdrawn from the study treatment. Blood~     samples for plasma IL-6 will be obtained prior to randomisation and at day 3-5 post~     randomisation for IL-6 & IL-1 measurement. Safety will be measured at 30 days post~     randomisation and outcome assessed at 6 months post randomisation.~   "
24278|NCT03249194|"~     The development of direct acting anti-virals (DAAs) for the treatment of Hepatitis C virus~     (HCV) has changed the landscape of HCV therapy dramatically in the last several years with~     reported sustained virologic response (SVR) rates in excess of 95% for treatment-naïve HCV~     positive patients including those who have received liver or kidney transplants. Since these~     new regimens do not include interferon and have already been studied in the post-liver and~     kidney transplant setting, they now offer a unique opportunity to expand the donor pool and~     improve the lives of those awaiting renal transplant. The address this gap in knowledge, the~     investigators hypothesize that pre-emptive treatment with a direct acting anti-viral HCV~     medication to cure HCV soon after transplant would allow for safe transplantation of HCV~     positive kidneys in disadvantaged and needy HCV negative kidney recipients with acceptable~     risks and improved survivals compared with historical cohorts.~   "
24279|NCT03249181|"~     To evaluate dolutegravir (DTG) efficacy in women who present with untreated HIV in late~     pregnancy.~      An open-label, multi-centre randomised controlled trial of DTG vs efavirenz-based regimens~     for women commencing cART in late pregnancy. HIV positive pregnant women presenting with~     untreated HIV infection in late (≥28 weeks gestation) pregnancy will be randomised 1:1 to~     receive DTG (50mg once daily) + 2 nucleoside reverse transcriptase inhibitors (NRTIs) or EFV~     + 2 NRTIs (SoC)~   "
24280|NCT03249168|"~     Despite recent advances in minimal invasive surgery, postoperative pain control remains a~     challenge for both surgeons and anesthesiologists . Currently, laparoscopy has an obvious~     favor for both diagnostic and therapeutic procedures of pelvic and abdomen; while it is~     minimally invasive, has less pain, and needs less postoperative analgesic use compared with~     open surgeries . Shoulder pain is a frequent problem following laparoscopic procedure~   "
24281|NCT03249155|"~     The target of this clinical trial is Freezing of Gait symptom (FoG), and associated falls.~     The project is aimed to evaluate the effects of an innovative experimental protocol to treat~     Parkinson (PD) Patients with FoG. This new physiotherapy protocol is based on the recovery of~     the correct mental representation of the movement, through Action Observation. A method that~     can facilitate the process of re-learning correct motor strategies, and at the same time~     avoid the phenomena of external cues dependency. Our version of the Action observation method~     uses video-clips of gait exercises. In these video-clips the audio part was obtained with the~     sonification of the kinematics of the body movements. We postulate that action observation,~     through the activation of the mirror system, is able to reactivate stored motor programs~     concerning walking ability, which can be used to facilitate recovery of defective motor~     control and overcome freezing of gait. Moreover, given that patients with PD and FoG may have~     major shortages of attention resources, a multisensory approach (audio-visual) would help to~     further reduce the attention load, facilitating learning processes. Therefore half of~     participants received an experimental protocol with Action Observation plus signification~     while the other half received a traditional protocol combining visual and auditory cues.~   "
24282|NCT03249142|"~     This is a randomized, open, comparative, multi-centre study which will recruit up to 66~     patients. The objective is mainly to explore the safety and feasibility in neo-adjuvant~     first-line ovarian cancer (including patients with primary peritoneal or fallopian tube~     adenocarcinoma) of various combinations of durvalumab with chemotherapy with or without~     tremelimumab.~   "
24283|NCT03249129|"~     The purpose of the study is to detect the presence of autoantibodies and autoantigens in~     cerebrospinal fluid early (<48 hours) following spinal cord trauma.~      The study also aims to define the central or peripheral origin of autoantibodies by looking~     for their simultaneous presence at the blood level and to evaluate the prognostic value of~     the presence of autoantibodies within the cerebrospinal fluid, as well as on the initial~     clinical severity than on the recovery potential.~   "
24284|NCT03249116|"~     Adolescence and young adulthood is a critical period for the development of social anxiety,~     which is often linked to other mental health challenges such as depression, mood disorders,~     and substance abuse. Initial evidence suggests that interacting with animals can reduce~     stress and anxiety, but no research has tested whether this benefit extends to adolescents at~     risk for social anxiety disorder. Additionally, researchers and clinicians do not understand~     what mechanism is responsible for anxiety reduction in animal-assisted interventions (AAIs).~     Therefore, the objectives of this study are to explore the specific mechanisms by which~     interacting with a therapy dog reduces anxiety, and to test whether such an interaction~     reduces anxiety in adolescents with varying levels of social anxiety.~   "
24285|NCT03249103|"~     The primary objective is to determine whether daily dosing with NYX-2925 changes markers of~     central pain processing in subjects with fibromyalgia by evaluating changes in evoked pain,~     and visual stimulation, functional magnetic resonance imaging (fMRI), resting state function~     connectivity magnetic resonance imaging (rs-fcMRI) and proton magnetic resonance spectroscopy~     (H-MRS) in fibromyalgia subjects on active drug versus placebo.~   "
24286|NCT03249090|"~     The current study is designed to test nationally whether patients' outcomes and utilization~     of services can be improved through symptom monitoring via patient-reported outcomes between~     visits.~   "
24287|NCT03249077|"~     In preparation for the roll out of the Medicare Diabetes Prevention Program (DPP) in 2018,~     Kaiser Permanente Northwest (KPNW), a large, integrated health care system, plans to pilot~     the implementation of DPP starting in April 2017. Patients 40 and older at high risk for~     diabetes will be offered DPP online or DPP in-person. A pragmatic, rigorous, quantitative and~     qualitative evaluation will be conducted to compare patients enrolled in DPP (either online~     or in-person) to those not enrolled to better inform future implementation efforts of DPP~     within and outside of KPNW.~   "
24288|NCT03249064|"~     This study aims to evaluate some differences in the immune system between patients with~     vitiligo and patients without the disease.~      These differences will be evaluated by the extraction of peripheral blood that will be~     analyzed before the treatment and after the treatment that, in the habitual way and at the~     discretion of the responsible dermatologist.~      Patients agreeing to participate in the study will be subjected to extraction of two tubes~     (20 ml) of peripheral blood (baseline) and after 12 weeks (+/- 5 days) of treatment.~      Therefore, neither treatment nor follow-up visits will be modified by participation, but will~     be the same whether or not participate in the study.~      In the case of controls, two peripheral blood tubes (20ml) will be removed in a single~     participation.~      Patients with vitiligo will also be asked to complete questionnaires to measure stress,~     depression and perception of disease (PSS-10, Skindex-29, HADS, Likert) before and after 12~     weeks (+/- 5 days) of therapeutic intervention .~      This study will include 20 patients with active non-segmental vitiligo and 10 controls~     without the disease. The duration of participation in this study will be 12 weeks (+/- 5~     days) for patients with vitiligo and a single participation (extraction of 20 ml of~     peripheral venous blood) for the controls.~   "
24289|NCT03249051|"~     The aim of this study is to investigate whether an individualized determination of energy~     requirements using indirect calorimetry instead of a formula-based approach leads to an~     optimized nutritional support and as a consequence to an optimized nutritional status of the~     critically ill, mechanically ventilated patients measured by the phase angle.~   "
24290|NCT03249038|"~     Estimated blood loss is an important parameter recognized as a standard practice in~     anesthesiology and others medical specialties, with relevant clinical and research~     applications. Currently is no model capable of accurately estimate blood loss. The purpose of~     this study is to evaluate the accuracy of a novel model.~   "
24291|NCT03249025|"~     Chronic pain is defined as 'an unpleasant sensory and emotional experience associated with~     actual or potential tissues damage, or described in terms of such damage. It is estimated~     that 1 in 5 Canadians experience chronic pain Chronic pain is associated with the worst~     quality of life compared with other chronic diseases such as chronic lung or heart disease.~     Many of these problems are confined to a specific anatomic structure, and can be diagnosed~     and treated by injections, physical therapy, surgery, etc. Nonetheless, other individuals~     experience a more generalized pain. This condition has also resulted I depressed mood, bad~     relations with other people, sleep disturbances and poor quality of life.~      The condition is very difficult to manage, and multiple methods have been recommended.~     Therapeutic intravenous infusion may be considered as one of these methods. Patients come for~     infusions of non-opioid medications under medical supervision and in a scheduled fashion. Two~     most commonly used mediation are lidocaine and ketamine.~      Even though it is common to use multiple medications with complementary mechanisms of action~     to treat pain a combined lidocaine-ketamine infusion has never been studied Therefore, the~     purpose of this research study is to determine whether mixture of two medications (ketamine~     and lidocaine) infused intravenously 1 time per month for 6 months results in reduction of~     pain unpleasantness.~   "
24292|NCT03249012|"~     This study aims to compare two different protocols commonly used in the management of post~     thyroidectomy hypoparathyroidism : PTH based calcium repletion and empiric repletion. The~     investigators aim to compare the quality of life associated with these two protocols in a~     randomized trial.~   "
24293|NCT03248999|"~     This study evaluates individual and collective factors of ESBL and CRE carriage in nursing~     homes.~   "
24294|NCT03248986|"~     A single-center, observational, prospective, single dynamic cohort study with before-after~     design. Treatment with 6 sessions using dry needling with DNHS® (Dry Needling for~     Hypertonicity and Spasticity) on the spastic muscles of the affected arm in patients with~     stroke. Spasticity will be assessed by Modifying Modified Ashworth Scale (MMAS),~     functionality with the Fugl-Meyer scale for the upper limb, motor recovery with Brunnstrom~     Stages Scale (BSS) and upper limb spasticity pattern (ULP), pain by 10-points Numerical~     Rating Scale (NRS10) and the quality of life with the Euro QoL 5D survey.~   "
24295|NCT03248973|"~     Successful Treatment of Maternal Listeria Monocytogenes Bacteremia in the First Trimester of~     Pregnancy~   "
24296|NCT03248960|"~     The primary purpose of this study is to validate the sensitivity and specificity of the~     iTreat Flu A+B Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B~     as compared to viral culture.~      The secondary aims are to:~      Validate the sensitivity and specificity of the iTreat Flu A+B Test and the ellume.lab Flu~     A+B Test in detecting influenza A and influenza B as compared to Reverse Transcriptase~     Polymerase Chain Reaction (RT-PCR).~      Evaluate the correct interpretation of the iTreat Flu A+B Test by subjects with~     influenza-like symptoms.~      Evaluate the subjects' satisfaction with the convenience, comfort and ease of use of the~     iTreat Flu A+B Test.~      Evaluate the operators' satisfaction with the ease of use of the ellume.lab Flu A+B Test.~   "
24297|NCT03248947|"~     This pilot study examines the feasibility and acceptability of transitioning office-based~     buprenorphine treatment of opioid use disorder from physicians to pharmacists. Results from~     this study will inform the development of a future multi-site randomized clinical trial.~   "
24298|NCT03248934|"~     The primary objective of this study is evaluate the diagnostic accuracy of a patient~     self-administered clinical examination of the hip compared with a traditional clinical~     examination (i.e. index test).~   "
24299|NCT03248921|"~     The purpose of this study is to identify measures of obesity, functional capacity, and~     specific biomarkers that may be predictive of obesity and post-operative outcomes.~   "
24300|NCT03248908|"~     In this double blinded randomized controlled study, the pupillary dilation reflex is used for~     as a nociceptive indicator for opioid administration during elective surgery under general~     anesthesia.~   "
24315|NCT03248713|"~     The purpose of this protocol is to examine whether mifepristone, a medication with~     glucocorticoid receptor antagonist activity, may be a potential treatment for Tobacco Use~     Disorder (TUD). Mifepristone has already shown promise as a potential treatment for PTSD (1)~     and alcohol use disorder (AUD) (2), but no previous studies have examined the therapeutic~     potential of mifepristone for TUD. This will be a double-blind, placebo-controlled study on~     the effects of a 7-day treatment with 600 mg mifepristone, or placebo, on cognitive function,~     tobacco withdrawal severity, and smoking behavior.~   "
24301|NCT03248895|"~     Mobilte Direct Observation Therapy (MDOT) is a technology has the potential to be a cost~     effective approach to direct observation of therapy administration, the latter being one of~     the most accurate methods of evaluating adherence. Use to date, as confirmed by the rapid~     systematic review, has been limited mainly to TB and sickle cell disease and there have been~     no published reports on the use of MDOT to monitor inhaled therapy. Due to the increasing~     incidence of childhood asthma worldwide, there is a need for new innovative approaches to~     support children and their parents with asthma management, especially since national and~     international guidelines have advised healthcare providers to periodically assess inhaler use~     as part of asthma management.~   "
24302|NCT03248882|"~     Phase 2a, dose-ranging Study with PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)~   "
24303|NCT03248869|"~     Mobile health applications (MHA) are increasingly being explored as tools to assist in~     management of chronic diseases. Little is known regarding which characteristics of MHAs are~     effective and there is limited data suggesting a real-world impact on health outcomes. Asthma~     is one of the most common and costly of the chronic diseases, impacting a broad range of the~     population including both children and adults. It is a variable disease necessitating regular~     medication use, monitoring of symptoms, and avoidance of specific triggers. These~     characteristics of asthma make it a chronic disease that is particularly amenable to having~     an MHA facilitate active monitoring outside of periodic traditional medical visits. The study~     team has designed a MHA focused on asthma subjects to test the feasibility of an asthma~     mobile health application (AMHA). The AMHA 2.0 study is the result of a collaboration between~     MHA developers and Mount Sinai faculty with expertise in the fields of asthma, research~     design, data storage, and data analysis. AMHA 2.0 incorporated elements of usual clinical~     care (that may take place during typical office visits), such as medication reminders, a~     daily asthma diary to track asthma control (AC) and medication use, patient education and~     assessments of quality of life (QoL), and health care utilization (HCU).~   "
24304|NCT03248856|"~     In this study Triamcinolone acetonide will be applied intratympanically before cochlear~     implant surgery. After round window exposure, a perilymph sample and simultaneously a blood~     sample will be drawn. Triamcinolone levels will then be analyzed in the samples.~   "
24305|NCT03248843|"~     This is an open label, dose escalation study to evaluate the safety and tolerability of KN035~     in Japanese patients with advanced and metastatic solid tumor. The dose escalation will~     follow the widely used 3+3 design.~   "
24306|NCT03248830|"~     The investigators will evaluate the accuracy of non-invasive hemoglobin monitor (Sp-Hb)~     compared to traditional laboratory hemoglobin (Lab-Hb) in children with congenital heart~     disease. The investigators will also compare the accuracy of Sp-Hb in cyanotic children to~     acyanotic children.~   "
24307|NCT03248817|"~     the investigators will compare variable infusion of phenylephrine (at a starting rate of 0.75~     mcg/Kg/min) with fixed rate (0.75 mcg/Kg/min which will stop of reactive hypertension~     occurred) and single shot (1.5 mcg/Kg) phenylephrine~   "
24308|NCT03248804|"~     Dietary protein is a key element of most effective weight loss regimens. This study will~     investigate the effects of consuming soy protein on body composition and cardiometabolic~     health within the context of an effective weight loss and maintenance program called the~     Colorado Diet.~   "
24309|NCT03248791|"~     Comparison will be conducted between continuous variable infusions of both drugs~     (Phenylephrine and Norepinephrine) with starting doses of 0.75 mcg/Kg/min and 0.1 mcg/Kg/min~     respectively for prophylaxis against Post-spinal hypotension during cesarean delivery.~   "
24310|NCT03248778|"~     Specific aims of the 1-year project are to pilot test the disclosure support intervention by~     (a) evaluating acceptability and feasibility with a preliminary randomized trial among 10~     HIV+ mothers (5 in the intervention group and 5 in the treatment as usual (TAU) group) and~     (b) assessing outcomes in mothers (quality of life and mental health indicators, adherence,~     social support, and disclosure stress, efficacy, readiness, and completion). The intervention~     will be compared to treatment as usual, with baseline (0 weeks), immediate post-intervention~     (4 weeks), and 12-week follow-up (16 weeks) assessments.~   "
24311|NCT03248765|"~     The purpose of this study is to determine if the research results obtained in animal models~     of pain - that show that being in pain for some time increases opioid use beyond what is~     expected to treat the current pain - also apply to patients with chronic pain.~   "
24312|NCT03248752|"~     The purpose of this study is to examine the effect of monitoring and sharing physical~     activity outcomes (using Fitbit technology) on physical activity participation in those who~     have received an exercise prescription from their physician.~      Primary research question: Does shared physical activity outcomes from wearable technology~     with a participant's physician improve overall physical activity over 3 months compared to~     shared outcomes with a family member, unshared outcomes (normal wearable technology~     condition), and a control group (no wearable technology condition) following an exercise~     prescription from one's physician? Physical activity will be measured as minutes of moderate~     to vigorous physical activity per week.~      Hypothesis: Knowledge that physical activity outcomes will be shared with a participant's~     physician will serve as a proxy-supervision intervention and improve physical activity~     adherence in comparison to all other groups. Self- and partner shared outcomes conditions~     will be more effective than the control group.~   "
24313|NCT03248739|"~     A randomized trial comparing small versus large catheters in terms of occlusion and need for~     replacement to confirm differential occlusion risk based on catheter size. This study will be~     done to determine whether external ventricular drain catheter diameter has any effect on risk~     of occlusion.~   "
24314|NCT03248726|"~     Colonoscopy is the best method to detect colorectal cancer and colonic polyps. Studies showed~     that adenoma detection rate positive correlation with good bowel preparation which makes~     bowel preparation an important issue. Hence, investigators conduct a clinical trial about~     adding another laxative agent to morning single dose low-volume PEG. To see if this new~     regimen could have non-inferior efficacy and lower life/sleep impact compared with standard~     regimen.~   "
24316|NCT03248700|"~     Women were given a vitamin A tracer, and blood was sampled to determine individual and group~     vitamin A kinetics. Data were subsequently modeled using compartmental analysis to determine~     effects of study length on model outcomes.~   "
24318|NCT03248674|"~     Patients with chronic kidney disease (CKD) before kidney transplantation require that~     obstructive coronary artery disease (CAD) is excluded, as cardiovascular complications are~     the leading cause of mortality in kidney transplant patients. However, in this patient~     population, the optimal method for the detection of obstructive CAD has not been identified.~     Noninvasive stress tests such as Dobutamine stress echocardiography or nuclear perfusion~     study have low diagnostic accuracy. CT fractional flow reserve measurement (CT FFR) is a~     novel non-invasive (FDA approved) imaging test to identify obstructive CAD. The goal of this~     project is to evaluate the diagnostic accuracy of CT FFR in the detection of obstructive~     coronary artery disease in patients with chronic kidney disease before kidney~     transplantation.~   "
24319|NCT03248661|"~     This study will randomly assign 220 men and women to either a social media intervention or a~     standard reminder system to have a repeat screening test for colo-rectal cancer.~   "
24320|NCT03248648|"~     To compare the efficacy of intra-articular administration of neostigmine versus ketamine as~     adjuvant analgesics after knee arthroscopy.~   "
24321|NCT03248635|"~     Background:~      The Division of Cancer Epidemiology and Genetics does research into the causes of cancer and~     ways to prevent it. It uses data from questionnaires. Sometimes, pre-testing a questionnaire~     with a group of volunteers can help researchers find errors in it and learn ways to improve~     it.~      Objectives:~      To test a questionnaire for problems that might cause response errors and to develop ideas~     for improving it. To test how long it takes people to complete it.~      Eligibility:~      Adults ages 35-75. Volunteers both with and without a history of tobacco use and with or~     without a family history of cancer are needed.~      Design:~      Participants will be screened with a phone call.~      Participants will be told what background data to bring to the 1 study visit.~      An interviewer will give the participants the questionnaire. It will be done with pen and~     paper. It will take about 1 hour.~      There will be multiple-choice and open-ended questions. They will be about lifestyle,~     medical, and environmental factors. Some of the questions will be about possibly illegal or~     highly sensitive behaviors.~      Participants will note any questions that they find hard to answer for any reason. They will~     be asked to answer the best they can, but they can skip any question that they prefer not to~     answer.~      The personal data of participants will be deleted when the study is done.~      The interviewer will observe participants while they do the questionnaire. He or she will~     look for things like long pauses and confusion.~      Participants will discuss the exam with the interviewer after they finish. This will take~     about 1 hour.~   "
24322|NCT03248622|"~     Background:~      Treatment of some diseases can suppress the immune system. This can cause other conditions to~     reactivate. Recent cases have shown that hepatitis B virus (HBV) reactivates in people who~     had already recovered from it during treatment for chronic hepatitis C (CHC). Their treatment~     was direct-acting antiviral (DAA) agents. Researchers want to see how common this~     reactivation is. They want to learn what the effects are. They will study data that have~     already been collected.~      Objectives:~      To study HBV reactivation in people with CHC and resolved HBV infection who are being treated~     with interferon-free DAA-based therapy.~      Eligibility:~      Data were collected from adults 18 and older in studies that were done in 2012 and 2016.~      Design:~      Researchers will screen the records from the previous studies. They will identify~     participants who had HBV infection before they got DAA-based treatment.~      Researchers will take data from those records. This will include data on:~        -  Age, sex, race, and ethnicity~        -  Treatment and disease status~        -  Lab results~      Researchers will test stored samples. They will test samples that were taken before, during,~     and after treatment. They will check if HBV was reactivated. They will also check if other~     clinical outcomes occurred.~   "
24323|NCT03248609|"~     Investigate the postprandial glycemic responses of healthy individuals when consuming~     commercially available table grape varietals or grape juice, compared to a standard amount of~     glucose.~   "
24324|NCT03248596|"~     The aim of the study is a better understanding of hemorrhagic events causes in patients with~     ECMO, prevent them and decrease the number of transfusion.~   "
24325|NCT03248583|"~     Individuals living with food insecurity are disproportionately affected by overweight and~     obesity and associated chronic health problems. There remains a lack of sustainable and~     scalable interventions targeting widespread barriers to access to healthy foods in this~     population to increase the nutritional quality of foods purchased for preparation and~     consumption at home.~      This randomized controlled proof-of-principle trial was designed to examine the feasibility~     and initial efficacy of a default option in enhancing the nutritional quality of groceries~     selected via the online shopping service of a local grocery store under conditions that mimic~     the financial constraints typical of individuals living with food insecurity.~      In behavioral economics, the default option refers to the option a consumer selects if no~     active choice is made. The notion of the default option is based on the concept of~     asymmetrical or libertarian paternalism, which seeks to subtly shift consumer behavior in~     a manner that promotes welfare, but without overtly interfering with the individual's freedom~     to choose.~      It was hypothesized that the default option effectively increases the nutritional quality~     of foods purchased online, compared to monetary incentives and psychoeducation about~     nutrition.~      Female undergraduate students (n = 60) selected food for one week using the online shopping~     service of a local grocery store with a budget corresponding to maximum weekly Supplemental~     Nutrition Assistance Program (SNAP) benefits. Before completing the task again, participants~     were randomized to: (1) a small monetary incentive for selecting groceries that meet~     nutritional guidelines (n = 17), (2) an educational brochure (n = 24), or (3) a default~     pre-filled online shopping cart containing a nutritionally balanced selection of groceries to~     which they could freely make changes (n = 18).~      Primary outcome measures capture the nutritional quality of groceries selected/ purchased.~   "
24326|NCT03248570|"~     This is a multicenter phase 2 open label study of pembrolizumab in patients with metastatic~     castrate resistant prostate cancer (mCRPC) with or without DNA damage repair defects.~   "
24364|NCT03248076|"~     Opioids is known that produce not only analgesia but also hyperalgesia through activation of~     central glutaminergic system-GABA. At the same time, recently it was found that the main~     opioid receptor (OPRM1) is present on human granulosa cells and exogenous opiates and their~     antagonists can influence granulosa cell vascular endothelial growth factor (VEGF) production~     via OPRM1, causing ovarian hyperstimulation syndrome.~      This study aims to investigate if a single exposure to opioids is enough to produce~     activation of stress mechanism during oocyte retrieval.~   "
24433|NCT03247179|"~     This project is a preliminary randomized controlled trial testing the potential impact of the~     PTSD Coach mobile application at reducing posttraumatic stress and pain symptoms among~     acutely injured trauma patients. Immediately following the injury, patients will be randomly~     assigned to use the PTSD Coach app, or to the treatment as usual condition.~   "
24327|NCT03248557|"~     Ventricular fibrillation (VF)-related sudden cardiac death (SCD) is a leading cause of~     mortality. Patients may survive with neurological damage despite state-of-the-art treatment.~     Current biological and imaging parameters show significant limitations on early predicting~     cerebral performance at hospital admission. A spectral-based model was recently suggested to~     correlate time-dependent VF spectral changes with acute cerebral injury in comatose survivors~     after cardiac arrest, which opens the possibility to implement early prognostic tools in~     clinical practice. The AWAKE trial is an investigator-initiated, multicenter, observational~     trial aiming to validate a spectral-based model to early predict cerebral performance and~     survival in resuscitated comatose survivors admitted to specialized intensive care units. The~     primary clinical outcome is favorable neurological performance (FNP) during hospitalization.~     Patients will be categorized into 4 subsets of NP according to the risk score obtained from~     the predictive model. The secondary clinical outcomes are survival to hospital discharge, and~     FNP and survival after 6 months of follow-up. Model-derived categorization will be compared~     with clinical outcomes to assess model sensitivity, specificity and accuracy. Eligible~     patients will be included prospectively and retrospectively, using an electronic Case Report~     Form to enter data from medical records and in-person interviews. Patients will be divided~     into: study group (predictive data required) including comatose (Glasgow Coma Scale -GCS- ≤8)~     survivors undergoing temperature control after return of spontaneous circulation (RoSC), and~     control group including patients who regain consciousness (GCS=15) after RoSC. VF tracings~     prior to the first DC shock will be digitized and analyzed to derive spectral data and risk~     scores.~   "
24328|NCT03248544|"~     Vitamin D supplementation not only has beneficial effects on morbidity and mortality in~     critically ill patients but it may also lead to alleviate of seizure, brain edema, infection,~     pain and some other perioperative complications, possibly in part through an attenuation of~     the immune response.In this trial patients with brain tumor under craniotomy will receive a~     single high dose vitamin D compared to control group.~   "
24329|NCT03248531|"~     Hidradenitis suppurativa (HS) is a painful, long-term skin condition that causes abscesses~     and scarring on the skin.~   "
24330|NCT03248518|"~     Fatigue is common and disabling for most patients with inflammatory rheumatic disease.~     Therapies designed to improve physical activity and 'talking' treatments, which positively~     help patients change the way they think and behave, are both helpful in reducing the burden~     of the fatigue. However, few patients have access to these treatments in most health~     services. This situation results from the absence of standardised programmes and limited~     availability of relevant therapists.~      The investigators aim to enhance access to fatigue alleviating physical activity and talking~     therapies by testing innovative,standardised and cost-effective approaches to treatment~     delivery.~      The investigators will also use this opportunity to understand how to select the best~     treatment for a patient based on their individual profile and to better understand how these~     treatments actually work. This in turn may lead to more refined and effective therapies in~     the future.~   "
24331|NCT03248505|"~     This study aim analyze the immediate effects of conventional transcutaneous electrical nerve~     stimulation (TENS) and Burst TENS combined or not with cryotherapy in patients with~     non-specific low back pain.~      All subjects will be submitted to an evaluation of the painful sensation, through the~     numerical rating scale, and pain threshold, through algometry, before, immediately after the~     intervention and 25 minutes after.~   "
24332|NCT03248492|"~     Some HER-2 breast cancer patients do not respond or build resistance to current treatment.~     DS-8201a is a new experimental product that is a combination of an antibody and a drug. It~     has not yet been approved for use. DS-8201a may slow down tumor growth. This might improve~     outcomes for these patients.~   "
24333|NCT03248479|"~     This trial will evaluate Hu5F9-G4, a monoclonal antibody which is designed to block a protein~     called CD47, which is widely expressed on human cancer cells. Blocking CD47 with Hu5F9-G4 may~     enable the body's immune system to find and destroy the cancer cells. In this study, Hu5F9-G4~     may be given alone or in combination with azacitidine to patients with acute myeloid leukemia~     (AML) or higher risk myelodysplastic syndrome (MDS). Azacitidine is a drug used for treatment~     of AML or MDS in patients who are not eligible for typical chemotherapy.~      The major aims of the study are: to confirm the safety and tolerability of Hu5F9-G4~     monotherapy in a relapsed/refractory AML and MDS population, and of Hu5F9-G4 in combination~     with azacitidine in previously untreated AML and MDS; and to evaluate the efficacy of~     Hu5F9-G4 monotherapy in relapsed/refractory AML/MDS, and of Hu5F9-G4 in combination with~     azacitidine in previously untreated AML/MDS, as measured by the objective response rate.~   "
24334|NCT03248466|"~     To investigate the treatment effect between Traditional treatment and transplantation of~     autologous PRG combined with autologous BMMSCs for treatment of diabetic foot ulcer.~   "
24335|NCT03248453|"~     The aim is to investigate if feedback given by an automatic and objective system in simulated~     colonoscopy (the investigation of the large intestine) increase learning and time spent~     practicing.~   "
24336|NCT03248440|"~     This protocol for SUN-131 1.5% TDS is developed for the treatment of chalazion. SUN-131 1.5%~     TDS is designed for local delivery of a corticosteroid, to the upper or lower eyelid. The~     purpose of this study is to evaluate the efficacy and safety of SUN-131 1.5% TDS as compared~     with placebo TDS in the treatment of a chalazion.~   "
24337|NCT03248427|"~     CORALLEEN is a two-arm, randomized, multicentric study in postmenopausal women with primary~     HR+/HER2 negative Luminal B breast cancer that will explore if the combination of ribociclib~     with letrozole offers clinical benefit at least comparable to that of standard chemotherapy.~   "
24338|NCT03248414|"~     In this study, we are going to investigate the efficacy of Lactobacillus Sakei on reduction~     of fat mass assessed by DEXA compared to plaebo.~   "
24339|NCT03248401|"~     To investigate the effect of cilostazol compared with aspirin on carotid atherosclerosis in~     patients with type 2 diabetes mellitus~   "
24434|NCT03247166|"~     The TOPS™ SP System is intended to provide stabilization in skeletally mature patients. The~     system is designed to afford motion of the spine segment without fusion. The pur0pose of this~     prospective clinical study is to establish the safety and effectiveness of the TOPS™ System,~     when used following decompression, in the treatment of lower back and sciatic pain.~   "
24435|NCT03247153|"~     This study will examine the effect of corticosteroid treatment on heart function.~   "
24340|NCT03248388|"~     This study is being done to determine if wearable text-to-speech (TTS) and visual pattern~     recognition (VPR) technology can be used to extend the capabilities of the Argus II to allow~     patients to read and recognize faces and objects.~      The Argus II retinal prosthesis can restore rudimentary forms of vision to patients with bare~     light-perception vision. Using the prosthesis, patients can identify obstacles, handles,~     switches, eating utensils and demonstrate improved navigation when used in conjunction with~     other ambulation-assist tools. Current limits in the resolution of the device prevent useful~     reading or face recognition. The FDA has approved the Argus II as a humanitarian device.~      Present-day wearable text-to-speech converters are also capable of object and face~     recognition. Such systems have been developed to assist with these tasks in patients with~     severe low-vision. ORCAM is a commercially-available eyeglass-mounted visual pattern~     recognition system capable of converting photographs of text to speech. It is comprised of a~     camera, a small belt-worn computer, pattern recognition software and a small audio~     transducer. ORCAM can acquire the image of a sheet of paper and read the text to the user~     through a small speaker adjacent to the ear. In addition, ORCAM can be trained to recognize~     faces and speak the name of the individual to the user. ORCAM can also be used to recognize~     everyday products after being programmed.~   "
24341|NCT03248375|"~     The aim of this pilot study is to assess the efficacy of radiation segmentectomy with~     Theraspheres in patients with unresectable hepatocellular carcinoma that would qualify for~     thermal ablation as per the BCLC guidelines, but are unable to receive thermal ablation due~     to unfavorable location of target lesions.~   "
24342|NCT03248362|"~     This study aims to determine whether a programme of transcutaneous posterior tibial nerve~     stimulation (TPTNS) is a clinically effective treatment for urinary incontinence (UI) in care~     home residents and what the associated costs and consequences are.~   "
24343|NCT03248349|"~     Infections are common on the Intensive Care for both adult and pediatric patients. Adequately~     dosing antibiotic treatment is of vital importance but both under- and overdosing is frequent~     due to pathophysiological changes during critical illness. Moreover, the interplay of age and~     critical illness is even more understudied.~      To optimize antibiotic dosing and outcome of infectious disease, personalized dosing~     guidelines in critically ill patients are highly needed. In this prospective observational~     population pharmacokinetic study we will evaluate if target attainment for antibiotics is~     reached in critically ill children with current dosing guidelines. Using these data,~     individualized dosing guidelines will be developed.~   "
24344|NCT03248336|"~     This study is designed to evaluate changes in objective measures of disparity vergence after~     office-based vergence/accommodative therapy (OBVAT) for convergence insufficiency (CI) in~     children 12-17 years old.~   "
24345|NCT03248323|"~     Color coded blood flow and blood perfusion techniques are applied to the endovascular~     treatment of infrapopliteal arterial occlusion,to establish a method of quantitative~     evaluation of blood flow and tissue perfusion,to improve the level of calculation of~     condition and curative effect. So as to establish a new complete evaluation system of~     infrapopliteal arterial occlusive disease, to guide clinical further. At the same time~     establish a digital information platform for clinical, lay the foundation for the large~     research.~   "
24346|NCT03248310|"~     This study is being done to see the long-term results for patients who choose to have surgery~     for lymphedema (with the vascularized lymph node transfer), compared to patients who choose~     not to have surgery.~   "
24347|NCT03248297|"~     This study, performed over a course of 3 years in 5 collaborating hospitals in Cameroon,~     Africa, will randomize 750 women in labor with prolonged rupture of membranes ≥ 12 hours or~     prolonged labor ≥ 24 hours to 1 gram of oral azithromycin, 1 gram of azithromycin+2 grams of~     amoxicillin, compared to usual care (placebo). Women will be followed to ascertain maternal~     infectious outcomes and perinatal outcomes.~   "
24348|NCT03248284|"~     Tendon pathologies (enthesitis) are a characteristic component of psoriatic arthritis (PsA),~     and are observed in 35% to 50% of PsA patients. The Achilles tendon is one of the most~     commonly affected sites. This condition often causes great morbidity and loss of quality of~     life, and response only suboptimal to current intervention strategies. One of the main~     obstacles for the development of effective treatment methods is that the disease mechanisms~     remain poorly understood. To our knowledge, no one has yet ascertained the presence and~     function of immune-competent cells and inflammatory markers in tendons tissue from PsA~     patients suffering from Achilles enthesitis.~   "
24349|NCT03248271|"~     In this study investigator's aim to determine the impact of insulin therapy on hypotension~     and sarcopenia~   "
24350|NCT03248258|"~     Develop a Metastatic Breast Cancer (MBC)-specific electronic Treatment Plans (TP).~      Aim 1a: Patient interviews along with navigator, nurse, and physician focus group discussions~     will be used to identify factors that influence decision-making in treatment selection and~     the optimal approach for sharing information about prognosis and guideline-based care.~     Identify decisional needs for Shared Decision Making (SDM) in MBC. Investigators will conduct~     semi-structured interviews/discussion groups with patients, navigators, nurses, and~     physicians to elements important to decision-making.~      Aim 1b: Develop MBC-specific TP. Investigators will build upon Aim1a to systematically~     develop the TP intervention using the Ottawa Decision Support Framework. Investigators will~     test the TPs with 5 patients and conduct qualitative investigations to refine the TP using an~     iterative process.~   "
24365|NCT03248063|"~     Methicillin-susceptible Staphylococcus aureus (MSSA) bacteremia remains a major cause of~     community- or hospital-acquired bloodstream infections with an overall mortality estimated~     around 25%. Anti-staphylococcal penicillins (APs) such as oxacillin or cloxacillin are~     recommended as first-line agents. With the exception of first-generation cephalosporin (1GC)~     such as cefazolin, no alternative has yet proven a similar efficacy. Due to an unfavourable~     safety profile for high doses used in severe infection, an uneasy dosing schedule in patients~     with renal failure and possible recurrent stock-out events for APs, alternative to APs are~     needed. This led to propose an open-label, randomized, controlled parallel groups, phase IV,~     non-inferiority trial comparing the efficacy, the safety, and the ecological impact of~     cefazolin versus cloxacillin for the treatment of MSSA bacteremia in adults.~      The primary objective is to compare the therapeutic efficacy of cefazolin vs cloxacillin at~     day 90 after the inclusion. ~   "
24351|NCT03248245|"~     This study includes designing, implementing and evaluating the effectiveness of process-based~     measures for improving interprofessional collaboration in Norwegian primary schools (5-7th~     grades). Focusing on leadership and organizational development, the overarching aim is to~     improve the use of existing interprofessional competence within schools. The interventions~     include meetings at municipal-level (strategic), school-level (operative) and class-level~     (operative), with feedback procedures to ensure communication between and within all levels.~     Also school internal and school external collaborators are involved at all levels of~     intervention.~      In order to avoid contradictory roles, an implementation team is responsible for developing~     and implementing the intervention, while the research team conduct an independent evaluation.~     The model will be evaluated by a cluster-randomized design to evaluate the effectiveness of~     the intervention. The hypothesis is that schools that utilize the process-based intervention~     (intervention group) will improve their interprofessional team work in a way that enhances~     the pupil's learning- environment and teachers professional competence, self-efficacy and~     efficient use of working hours compared to their counterparts in the control group. We~     anticipate main effects to be found at pupil level, mainly through improved early assessment,~     intervention and efficient follow-up. The project is a collaboration between four Norwegian~     municipalities and includes a total of 37 Schools, half of which will be randomized to~     experimental condition and half to control condition.~      The project is financed by The Norwegian Directorate for Education and Training with a~     duration of three years and three months. The project is led by Professor Ira~     Malmberg-Heimonen. The project is a collaboration between Faculty of Social Sciences and the~     Work Research Institute (AFI), at Oslo and Akerhus University College of Applied Sciences.~     Participants in the project are Ira Malmberg-Heimonen (project leader), Anne Grete Tøge,~     Therese Saltkjel, Knut Fossestøl, Elin Borg and Selma Therese Lyng. Participants in the~     implementation team are Øyvind Pålshaugen, Hanne Christoffersen and Christian Wittrock, also~     from Oslo and Akerhus University College of Applied Sciences, in addition to Torbjørn Lund~     from the Arctic University of Norway~   "
24352|NCT03248232|"~     Transcatheter aortic valve implantation (TAVI) is well established, and can improve clinical~     outcomes of patients with severe aortic valve stenosis (AS) who are inoperable or have high~     surgical risk. Although the rates of periprocedural bleeding events are lower in TAVI~     compared to those in surgical aortic valve replacement, those in TAVI still remains high. In~     addition, current guideline recommended the dual antiplatelet (DAPT), clopidogrel plus~     aspirin, for a 3- to 6-month period after TAVI, however no evidences supports this approach.~     The antithrombotic regimen in patients undergoing TAVI is needed to be established.~      To establish the antithrombotic regimen in patients undergoing TAVI,~        1. the investigators assess the changes in platelet thrombus formation and white thrombus~          formation in patients undergoing TAVI measured by Total Thrombus Formation Analysis~          System (T-TAS).~        2. the investigators analyze plasma microRNAs, and shear stress by using computational~          fluid dynamics (CFD) to clarify the mechanistic factors regarding those changes.~   "
24353|NCT03248219|"~     Sleep disordered breathing (SDB) insidiously worsens metabolic function, heightens insulin~     resistance (IR), and in pregnancy is thought to precipitate gestational diabetes, preterm~     birth, growth restriction, gestational hypertension, and preeclampsia. Despite the fact that~     sleep disturbances are common during pregnancy, SDB remains under-recognized,~     under-diagnosed, and poorly understood, particularly in pregnancies affected by obesity.~     Sixty percent of pregnancies are now affected by obesity, yet the relationship between SDB,~     patterns of glycemia, and insulin resistance (IR) in obese pregnant women is a neglected area~     with major therapeutic implications to improve maternal and infant health. Using a~     prospective design in which diet and gestational age are highly controlled, the investigators~     propose to measure SDB (apneas/hypopneas) in obese pregnant women using an ambulatory sleep~     monitoring system. In parallel, robust patterns of glycemia will be measured with a~     continuous glucose monitoring system (CGMS), followed by a 75g oral glucose tolerance test to~     measure insulin action. The investigators global hypothesis is that worse SDB in part~     accounts for higher 24-hour patterns of glycemia in obese normal glucose tolerant (NGT)~     pregnant women in their 3rd trimester. We will test the hypothesis that: 1) In obese NGT~     pregnant women at 32-34 weeks gestation on a controlled eucaloric diet, higher apnea hypopnea~     index (AHI) will be positively associated with 24-hour glycemia measured by a CGMS and that,~     2) Higher AHI in obese NGT pregnant women at 32-34 weeks gestation on a eucaloric controlled~     diet will be associated with higher insulin resistance measured by a 75g oral glucose~     tolerance test (Matsuda Model). Early identification and treatment has the potential to~     decrease long-term maternal cardiovascular morbidity and mortality.~   "
24354|NCT03248206|"~     In this research work, the concept of strengthening technique of proprioceptive neuromuscular~     facilitation (PNF) incorporated with tendon gliding exercise (TGE) will be used to improve~     neuromuscular function of upper extremity of patients with diabetes mellitus. The first~     specific aim of the study is to examine the effects of home-based PNF exercise on the motor,~     sensation and functional performance parameters of upper extremity of the patients with~     diabetes mellitus. In addition, whether adding a tendon gliding exercise (TGE) to the~     home-based PNF exercises can provide better treatment effects for the patients with diabetes~     mellitus will also been investigated in this study. One of the hypothesis of this study is~     the prescribing home-based PNF exercise program has a positive treatment effect on~     neuromuscular function of the upper extremity of patients with diabetes mellitus. And,the~     other is home-based PNF in conjunction with TGE provides better benefits for neuromuscular~     function of the upper extremity of patients with diabetes mellitus.~   "
24355|NCT03248193|"~     Paclitaxel is a chemotherapy drug that is used to treat breast cancer, one of the most common~     cancers. It causes two side effects very often - hair-loss and numbness. Until recently,~     there have been no known ways to prevent or treat either side effect. Recently, cooling of~     the scalp to prevent hair loss caused by paclitaxel was approved. Our team is developing a~     method to prevent numbness caused by paclitaxel by using a device that cools the arms and the~     legs, while applying mild pressure, and this technique is called cryocompression. As scalp~     cooling use in day-to-day cancer care increases, future studies involving cryocompression to~     treat neuropathy must take this into account, lest patients be denied or are required to~     trade-off one treatment for the other. However, there is concern of causing a reduction in~     core body temperature, which would not be safe or a general intolerance to this treatment.~     Both scalp cooling and limb cryocompression individually have not shown to cause this, but~     simultaneous use has not been studied previously. Clinical safety studies, in healthy~     subjects and cancer patients would need to be conducted to prove this theory, which is being~     proposed by currently.~   "
24356|NCT03248180|"~     A 2-year prospective observational study comparing a group of patients in remitted states of~     psychosis undergoing guided antipsychotic dose reduction to a similar group of patients under~     maintenance antipsychotic treatment with the main outcome of interest that if the rates of~     relapse of psychosis between these two groups will be different.~   "
24366|NCT03248050|"~     Self-management of medical abortion (MA) pills purchased from pharmacies is considered to be~     one of the reasons behind falling morbidity and mortality from unsafe abortion in recent~     years. While pharmacy workers commonly sell MA medications over the counter, they have~     inadequate knowledge about how women should take the medications and their potential~     complications, and do not offer adequate information and counselling to women buying the~     drugs. This study aims to evaluate if a pharmacy-based intervention to promote use of a~     support hotline (Marie Stopes Zambia (MSZ) call centre) among MA purchasers can increase use~     of the call centre, and to assess whether correct MA use and acceptability of self-~     administered MA is higher among MA users who contact the call centre than those who~     self-administer MA without call centre support.~   "
24357|NCT03248167|"~     This project aims to determine whether cannabidiol (CBD), a compound derived from the~     cannabis plant, is effective in treating alcohol use disorder (AUD) in individuals with~     comorbid posttraumatic stress disorder (PTSD). Investigators will test the hypothesis that~     oral cannabidiol (CBD) will reduce alcohol drinking in individuals with AUD comorbid with~     PTSD. To test this hypothesis, 50 otherwise healthy adult participants with moderate or~     severe AUD and PTSD will be randomized to treatment with either CBD (400 mg daily) or~     placebo, for a period of 6 weeks, such that both participants and study staff are blind to~     treatment condition. Participants (each treated for 6 weeks) will be continuously recruited~     over a study period of 14 months until 50 have completed. Baseline and weekly data will be~     collected on alcohol usage and PTSD symptoms, and investigators will assess whether CBD~     treatment leads to a greater improvement in these measures relative to placebo, and whether~     reduction in alcohol drinking is temporally linked to improvement in PTSD symptoms. Subjects~     will also participate in a task designed to quantify the psychological and physiological~     links between negative emotion produced by re-experiencing PTSD trauma, and alcohol craving.~     The task will be administered at baseline, before treatment, and following 6 weeks of~     treatment. Treatment-associated reduction in alcohol craving elicited by trauma-associated~     negative emotion between CBD and placebo groups will be compared. This study will be the~     first to test whether CBD is effective in treating alcohol addiction and in treating PTSD in~     humans, and the first to examine the interaction between these treatment effects. Results~     will serve as proof of concept and provide guidance for a future larger clinical trial.~     Because CBD is a safe, readily available drug, such a trial would have an immense potential~     to prevent death, medical illness, and psychological suffering associated with AUD and PTSD.~     Further, because the brain circuits via which CBD acts to produce hypothesized effects are~     relatively well-understood, results may substantially advance understanding of the~     neurobiological basis of alcohol addiction.~   "
24358|NCT03248154|"~     The objective of the study is to analyze the different implications (such as graft loss and~     conversion of indeterminate depth burns) of biofilm infections in burn patients.~     Additionally, it also aims at comparing children's resistance to biofilm infection at wound~     site than adults'. 300 subjects from 3 different age groups will be enrolled in 3 arms.~   "
24359|NCT03248141|"~     Study Design~      A prospective observational, cross-sectional epidemiological study in U.S. site-based~     clinical practice settings.~      30 sites will enroll approximately 300 patients~      Participating patients - or their caregiver in the case of patients under the age of 18 -~     will be consented to participate.~      Physicians complete a retrospective chart review on each enrolled patient.~      Patients will complete a one-time study questionnaire.~   "
24360|NCT03248128|"~     The goal of asthma treatment is to achieve and maintain asthma control and to reduce the~     future risk of exacerbations. Inhaled corticosteroids (ICS) are considered as the most~     effective anti- inflammatory treatment for all severities of persistent asthma. For children~     >=5 years of age and adolescents whose asthma is uncontrolled, low-dose ICS plus adjunctive~     therapy with long-acting beta agonist (LABA) is considered as effective. Thus, this study is~     designed to evaluate the efficacy and safety of FF (ICS component)/VI (LABA component)~     compared to FF alone for the treatment of asthma, in subjects aged 5 to 17 years old~     currently uncontrolled on ICS. The study will be conducted over a total duration of~     approximately 29 weeks: 4 week run-in period, 24-week double-blind treatment period and~     1-week follow-up period. Subjects will be randomized to receive FDC of FF/VI or FF~     administered via ELLIPTA® dry powder inhaler (DPI). The dose of both FF/VI and FF alone will~     be selected based on the age of subjects. Subjects will receive a short acting beta 2 agonist~     (SABA) (albuterol /salbutamol) as a rescue medication throughout the study. A total of 870~     subjects will be randomized in the study. Of this, 652 subjects will be aged 5 to 11 years~     (cohort A), and 218 will be aged 12 to 17 years inclusive (cohort B). ELLIPTA is a registered~     trademark of GlaxoSmithKline (GSK) group of companies.~   "
24361|NCT03248115|"~     There is little information on the dietary intake, absorption, metabolism and bioavailability~     (degree to which a substance becomes available to the target tissues upon administration) of~     polyphenols (natural substances present in a variety of foods) in human participants.~      This study assessed the bioavailability in healthy participants of polyphenols from 2~     supplements containing green tea and green coffee extracts.~      Eleven participants were recruited and their habitual diet was assessed to estimate~     polyphenol intake. After completing a 24-hour urine collection, participants were given six~     green tea extract and three green coffee extract tablets, which they took daily for a period~     of 8 weeks. No tablets were taken during the last 4 weeks of the study. Further 24-hour~     urines were collected at 2, 4, 8 and 12 weeks.~      Participants were required to attend HNR (medical laboratory) the day after each 24hour urine~     collection. At these visits, they were asked to bring along their urine collections,~     completed documents (urine collection sheet, checklist for tablet intake/side effects) and~     any remaining supplements, which were used to assess tablet compliance.~      The investigators identified and quantified the amount of polyphenols in the supplement~     tablets as well as the amount of polyphenols and their metabolites in urine. The~     investigators then evaluated polyphenol bioavailability from the relationship between their~     dietary intake and urinary output.~      Evidence from this research could inform future intervention studies by providing data on the~     bioavailability of green tea and coffee polyphenols, and on the individual differences~     related to phenolic intake.~   "
24362|NCT03248102|"~     Acute appendicitis is the most common surgical emergency in childhood. Despite access to~     current diagnostic modalities, diagnosis may be challenging since the child may have~     difficulty in articulating symptoms. Additionally there is a high frequency of atypical~     presentation and rapid progression. Delayed diagnosis in children is reported as being up to~     60%. Delayed diagnosis >48hr increases the perforation rate from 21% to 71%. Around 20% of~     children presenting with appendicitis have perforated by the time they come to surgery.~      Appendix perforation is associated with a prolonged hospital stay and increased cost. Once~     perforated, major complication rates increase from 1.2% to 6.4%, median bed stay increases~     from 2 to 6 days and hospitalisation costs are estimated at US $33,348.~      Conversely, a false positive diagnosis leads to unnecessary surgery in 12%. It has been~     suggested that only 35% of surgical referrals with possible appendicitis actually need~     surgery thus impacting on resource use.~      A reliable test, especially if painless, would be very useful. If positive the child could~     undergo early appendicectomy in expectation of a reduction in the perforation rate (and,~     therefore, reduction in hospital stay). If negative the child could be discharged home~     safely. No adequate biomarker has been identified.~      Technology already exists to detect changes in Volatile Organic Compounds (VOC) in gases. VOC~     analysis is already used commercially to identify disease processes in animals and crops.~     Although VOC has been previously used to detect human diseases, it has never been used to~     look for changes in the composition of breath in appendicitis.~      The investigators hypothesise that the composition of VOC's in children with appendicitis~     will differ from those without. The investigators anticipate these differences will be of~     diagnostic and prognostic value in clinical practice. The feasibility of collecting breath~     samples from children with possible appendicitis to allow VOC testing has not been examined.~   "
24363|NCT03248089|"~     Tumor Derived cell free DNA (cfDNA) is increasingly used in the clinic to obtain genotype~     information about lung cancer, but its concordance with concurrent tumor-derived sequenced~     data is not known. The primary objective of this study is to demonstrate the non-inferiority~     of cfDNA-based versus tumor tissue-based genotyping.~   "
24367|NCT03248037|"~     Cornea transplant recipients who are using topical corticosteroids long-term to prevent~     transplant rejection will be randomized to use netarsudil or placebo.~   "
24370|NCT03247998|"~     After a stroke caused by a blockage (clot) in a blood vessel in the brain, patients may have~     the clot removed by threading a catheter from the groin up to the affected area of the brain.~     An anesthesiologist is involved in the patient's care during this procedure to maximize~     patient safety and procedural efficiency. The options for anesthesia for this procedure are~     general anesthesia (where the patient is unconscious) or sedation (where the patient is in a~     relaxed, calm, sleepy condition). Currently, it is unclear which of these anesthetic options~     contributes to the best patient outcome. The investigators would like to investigate whether~     or not one method of anesthesia (general or sedation) is better to use than the other when~     removing the clot.~   "
24371|NCT03247985|"~     Investigators are testing whether tacking mesh or self-fixating mesh used for inguinal hernia~     repair makes any difference in short-term pain or return to normal activities following the~     operation. Other studies have shown no significant difference in hernia recurrence rate when~     metal tacks are not used to hold the mesh in place.~   "
24372|NCT03247972|"~     Monoclonal antibodies against PCSK9 are innovative agents that provide very potent LDL~     reduction when administered on top of statins. PCSK9 antibodies prevent LDL receptor~     degradation and enhance circulatory LDL cholesterol clearance. High LDL is a major risk~     factor for PAD and therefore lipid-lowering therapy constitutes another important therapeutic~     intervention for patients with PAD. Evolocumab is a common PCSK-9 inhibitor that has been~     shown to reduce plasma LDL.~      In this study sixty subjects will be treated with high dose statins for 8 weeks followed by 8~     weeks of high dose statin + evolocumab (420mg/4 wk) therapy. The laboratory assessments will~     be performed at the screening (baseline), after 8 weeks of high-dose statin therapy, and 24~     hr and 8 weeks after high dose statin + evolocumab therapy~   "
24373|NCT03247959|"~     The Purpose of this study is to evaluate the effectiveness of active ( video game) and~     passive (video) distraction techniques on reducing fear and anxiety and improving oral health~     knowledge of children undergoing extraction in the dental operatory~   "
24374|NCT03247946|"~     Does upright feeding position of 3 month old infants reduce respiratory and ear morbidity~     during the following year?~   "
24375|NCT03247933|"~     Respiratory rehabilitation (RR) has been shown to provide benefits in patients with Chronic~     Obstructive Pulmonary Disease (COPD) with a degree of evidence A.~      These benefits are primarily focused on an increase in the capacity of effort for activities~     of daily living and in an improvement in the quality of life related to health (HRQOL) a~     constant to the RR critique is the fact that the benefits achieved with programmes are lost~     in a progressive and constant way once the patient completes the treatment and lost contact~     with the team.~      The introduction of new technologies in different fields of medicine has been a new approach~     when it comes to the management of various diseases and treatments in chronic patients. In~     the case of the RR telemedicine provides a new tool.~      COPD disease very prevalent and chronic it is generator of a high economic cost. The~     possibility of universalizing the rehabilitation treatment would involve a potential savings~     in this population group ,another potential benefit is as translational trial as part of the~     development of a new technology and its possible application to clinical practice.~      General objective: to determine whether a program of TeleRehabilitation (TeleRR)- Respiratory~     Rehabilitation Maintenance (RRm) after an intensive initial program of RR, is a useful~     intervention against the current usual strategy (intensive program of RR and a recommendation~     of not protected maintenance program).~      Method: clinical trial , open, randomized, multicenter, parallel group, and focus of~     superiority with a strategy of Telerehabilitation program respiratory of maintenance after an~     intensive RR for 8 weeks in patients diagnosed with grade moderately - severe stable COPD~     (Bode 3-7).~   "
24376|NCT03247920|"~     Randomized controlled open-label non-inferiority trial comparing complete intravenous~     antibiotic treatment with a short iv. course followed by oral antibiotics in neonates (0-28~     days) with probable bacterial infection.~      Primary outcome:~      - Bacterial re-infection within 28 days after finishing of antibacterial therapy.~      Secondary outcome(s):~        -  Pharmacokinetic profile of oral amoxicillin/clavulanic acid~        -  Quality of life~        -  Cost-effectiveness~        -  Alterations in gut microbiome~   "
24377|NCT03247907|"~     A study undertaken to investigate mouth leak for airway discomfort/dryness while using CPAP.~     This study will also measure how much humidification is required to treat subsequent upper~     airway discomfort/dryness from mouth leak by utilizing different levels and types of~     humidification.~   "
24378|NCT03247894|"~     Aim of the retrospective study was to evaluate the influence of the labour on the clinical~     course of the parturients with MS in selected 6 month follow-up interval and to evaluate to~     possible influence of the different anesthesia/analgesia types on the course of MS.~   "
24379|NCT03247881|"~     The objectives of this study are 1) to determine if consumption of mixed nuts influences food~     intake and choice, and 2) to determine how personality traits affect food choice, including~     mood, stress, tendency to seek approval, tendency toward food cravings, and approach to food~     intake control.~   "
24380|NCT03247868|"~     the aim of this study protocol is to describe, using a longitudinal study, a multimodal~     approach of treatment of cervical dystonia with botulinum toxin (BoNTA) and a new~     rehabilitation protocol named SPRInt (Sensory-motor perceptive rehabilitation integrated)~     approach based on motor learning techniques and spatial rehabilitation.~   "
24381|NCT03247855|"~     the aim of this study is to evaluate safety and efficacy of multivessel minimally invasive~     coronary artery bypass graft surgery through evaluating the possibility of reaching complete~     revascularization , the complications during surgery and the outcomes~   "
24382|NCT03247842|"~     Sixty patients with shoulder dystocia after breast surgery will receive either stellate~     ganglion neurolysis with or without supra-scapular nerve radiofrequency,~   "
24383|NCT03247829|"~     This observational post market study is intended to characterize hemodynamic-guided~     management of patients with an existing left ventricular assist device (LVAD) to protocol~     specified target ranges and its impact on functional status, quality of life, and~     readmissions~   "
24436|NCT03247140|"~     The PK Characteristics of the Co-administration of Rosuvastatin and Telmisartan/Amlodipine~     and JLP-1401 in Healthy Male Volunteers Volunteers~   "
24437|NCT03247127|"~     The study aimed to investigate the memory preservation and neurocognitive function protection~     of hippocampal avoidance whole brain radiotherapy (HA-WBRT) among people who speak Mandarin~     Chinese or Taiwanese.~   "
24384|NCT03247816|"~     The aim of the study is to understand the early experiences of Feraccru® in patients with~     inflammatory bowel disease (IBD) and iron deficiency anaemia (IDA) in the UK, including~     treatment effectiveness, patterns of use and tolerability. By describing the characteristics~     of patients treated with Feraccru® and their outcomes, this study will provide the medical~     community with important information to support treatment decisions for their patients. This~     will ultimately support improvements to patient care, including the long-term outcomes of~     patients with IBD and IDA~   "
24385|NCT03247803|"~     The air-Q and air-Q SP are commercially-available supraglottic airways (SGAs) that can be~     used for primary airway maintenance or as a conduit for FOI, as can be the Williams,~     Ovassapian, and Berman Intubating Airways. The air-Q products have the same overall~     geometrical design, but differ in their cuff inflating mechanisms, where the air-Q uses a~     traditional pilot balloon valve, while the air-Q SP utilizes a self-inflating cuff that~     dynamically adjusts according to the relative resistances to airflow between the patient's~     lungs and the device's cuff. The purpose of this study is to compare the single-operator~     intubation success using the air-Q SP versus the Williams Intubating Airway as a conduit for~     flexible bronchoscopic intubation (FBI) and to compare the single-operator intubation success~     using the air-Q SP versus the Williams Intubating Airway as a conduit for flexible~     bronchoscopic intubation. Both devices are commercially-available and being used in the study~     in accordance with their labeled intended use. The investigator envisage that the endpoint of~     the study will be single operator intubation success rate.~   "
24386|NCT03247790|"~     The purpose of this study is to measure how much of the drug gets into the blood stream and~     how long it takes the body to get rid of it during an acute migraine attack and also during~     the time between acute migraine attacks.~      Information about any side effects that may occur will also be collected.~      This study includes two study periods. Each study period requires an overnight stay in the~     Clinical Research Unit (CRU) for at least one night (and up to three nights), followed by up~     to two outpatient appointments. This study will last approximately 5-6 weeks (not including~     screening).~      Follow-up is required four to seven days after last dose of investigational drug. Screening~     is required within 28 days prior to the start of the study.~      This study is for research purposes only and is not intended to treat any medical condition.~   "
24387|NCT03247777|"~     Amateur female golfers were randomized to either a functional weight lifting group or a~     traditional weight lift group. Testing, consisting of performance measures and golf measures,~     was performed at baseline and after 10 weeks of weight lifting.~   "
24388|NCT03247764|"~     The prevalence of comorbid depression in patients with epilepsy is as high as 30-50%. The~     depressive symptoms severely affect seizure severity and quality of life in patients with~     epilepsy. The aim of this study is to register the diagnosis and treatment for depression in~     patients with epilepsy from the East China, determining the incidence rate of comorbid~     depression in patients with epilepsy and the choices for the antidepressant treatment. At the~     same time, neuroimaging data such as brain MRI and blood sample will be collected to analyze~     some biomarkers for the comorbidity of epilepsy and depression.~   "
24389|NCT03247751|"~     To evaluate rotational stability of the investigational device implanted after cataract~     surgery.~   "
24390|NCT03247738|"~     In STEMI patients undergoing PPCI there is a delayed onset of action of oral P2Y12 receptor~     inhibitors, including prasugrel and ticagrelor. Crushing prasugrel and ticagrelor improves~     their PK and PD profiles as it favors drug absorption and onset of antiplatelet effects and~     because of this, it is commonly used in STEMI patients undergoing PPCI. However, despite the~     use of crushed tablets, up to one-third of patients may still have high on-treatment platelet~     reactivity (HPR) within the first 2 hours after loading dose (LD) administration of these~     oral agents. Cangrelor is a potent intravenous P2Y12 receptor inhibitor with rapid onset and~     offset of action associated with a greater reduction in ischemic events compared with~     clopidogrel in P2Y12 receptor naïve patients undergoing PCI. To date most studies have~     explored cangrelor in the setting of PCI subjects treated with clopidogrel. The PD effects of~     cangrelor in STEMI patients undergoing PPCI treated with a newer generation P2Y12 receptor~     inhibitor and how this compares with a crushed formulation of the oral drug is unexplored.~     The aim of this prospective randomized study is to investigate the PD effects of cangrelor in~     STEMI patients undergoing PPCI treated with crushed ticagrelor.~   "
24391|NCT03247725|"~     The present investigation aims at exploring the effect of including a pain app called Pain~     Monitor for chronic pain patients' daily monitoring. Three conditions will be set:~        1. usual treatment (waiting list)~        2. usual treatment + app (without alarms)~        3. usual treatment + app (with alarms)~   "
24392|NCT03247712|"~     The purpose of this study is to test the safety of neoadjuvant immunoradiotherapy as a safe~     means of down-staging Head and Neck Squamous Cell Carcinoma (HNSCC) prior to surgical~     resection.~   "
24393|NCT03247699|"~     Healthy Subjects will receive treatment orally with 120-200ml tap water in fasted state.~      Treatment in period A is the Basel phenotyping cocktail capsule. Treatment in period B~     consists of simultaneous intake of isolated formulations. In both study arms peripheral~     venous and capillary blood (DBS) samples will be drawn~   "
24394|NCT03247686|"~     The present study will examine the role of circulating RNA complexed with autoantibodies and~     immune complexes and its role in activation of inflammatory pathways in patients with primary~     Sjogren's syndrome. The study will be conducted in a subset of Sjogren's patients who have~     elevated levels of autoantibodies and a pattern of elevated interferon-stimulated gene~     expression in blood cells. A number of biochemical and clinical parameters will be analyzed~     to determine the potential therapeutic utility of nuclease therapy in Sjogren's syndrome.~   "
24395|NCT03247673|"~     This study is a Phase 1 Randomized, Double-blind, Three-arm, Parallel Group, Single-dose~     Study to compare the PK, safety and immunogenicity of the proposed biosimilar test product~     CT-P16 with EU-approved Avastin and US-licensed Avastin after a single IV infusion of 5mg/kg~     of each product to healthy male subjects~   "
24438|NCT03247114|"~     The study will consist of five occasions with one week in between. BOLD signal intensity of~     the hypothalamus will be measured using fMRI. Measurements will be done before and after~     drinking 300 ml plain water (reference) or water to which different sweeteners will be added.~   "
24396|NCT03247660|"~     Objective: To find out the effectiveness of pelvic-perineal physiotherapy in prevention and~     treatment of postpartum pelvic floor dysfunction caused by vaginal delivery. Design:~     Randomized, controlled and single blinded clinical trial. Participants will be randomly~     assigned to one of these groups: Experimental group: pelvic-perineal physical therapy plus~     hypopressive exercises plus training in lifestyle advice; Experimental group II: hypopressive~     exercises plus training in lifestyle advice; Control group: just training in lifestyle~     advice. In the 3 groups several physical therapy assessments will be undertaken: 1st before~     intervention, 2nd immediately after completing intervention; 3th, 4th, 5th and 6th after 3,~     6, 12 and 24 months. Study subjects: Postnatal women (6 and 8 weeks after vaginal delivery),~     primiparous, whose vaginal delivery has occurred in the PrÍncipe de Asturias Hospital,~     which have not been already treated for pelvic floor dysfunction, and after reading,~     understanding and freely signing an informed consent form. Sample size: 240 subjects will be~     included (80 subjects per group). Allowing for 15% of drop-outs and taking into account that~     17% of women in the intervention group may develop pelvic floor dysfunction (urinary~     incontinence) versus 40% in the control group, with an alpha risk of 0.05, a beta risk of 0.1~     in a bilateral contrast using the arcsine approximation. Data analysis: A descriptive~     analysis will be done of all variables. A confidence level of 95% (p <0,05) will be~     established for all the cases. Effectiveness will be evaluated by comparing between the two~     groups of the change in outcome variables between visits.~   "
24397|NCT03247647|"~     This study aims to examine the efficacy of an enhanced alcohol intervention among individuals~     who are mandated to complete an alcohol education activity as part of a university sanction.~   "
24398|NCT03247634|"~     A new, practical program, entitled Getting Ahead in a Just-Gettin'-By World, provides a novel~     approach to addressing this previously intractable problem. During the progression through~     the Getting Ahead program, individuals develop an understanding of the hidden rules of~     economic class and have an opportunity to craft a hopeful future story based on the practical~     concepts investigated in the modules. Getting Ahead has shown great success in various~     organizations and communities in multiple sectors, including healthcare, but has not been~     studied in the context of advancing cancer prevention and control.~   "
24399|NCT03247621|"~     In this protocol, the investigators propose a randomised controlled trail to explore the~     effects of environmental factors and the use of technology on eating behaviours. The~     investigators have planned two studies to investigate these effects, one on high school~     students from Raffles Institution, and the other on the university population in the National~     University of Singapore.~   "
24400|NCT03247608|"~     This is a single-center, pilot study that will evaluate the effectiveness of the AHA science~     based CarePlans and the Ambio Health technology in improving the risk adjusted 30 day~     readmissions rate, patient compliance, and biometrics. The study will also be used to assess~     the feasibility of similar heart failure transition programs in the future.~   "
24401|NCT03247595|"~     This study compares a colonoscopy preparation composed of magnesium citrate capsules to a~     preparation of polyethylene glycol solution. The hypothesis is that the magnesium citrate~     capsules work as well and are better liked by patients due to the lack of taste.~   "
24402|NCT03247582|"~     In order to understand the risks and benefits of edoxaban use in a real-world clinical~     setting in the NVAF indication, Daiichi-Sankyo Hong Kong proposed this non-interventional~     study (NIS) to gain insight into the safety of edoxaban use in non-preselected patients with~     NVAF.~   "
24403|NCT03247569|"~     In order to understand the risks and benefits of edoxaban use in a real-world clinical~     setting in the NVAF indication, Daiichi-Sankyo Thailand proposed this non-interventional~     study (NIS) to gain insight into the safety (bleeding, liver adverse events, all-cause~     mortality and other adverse events) of edoxaban use in non-preselected patients with NVAF.~   "
24404|NCT03247556|"~     This study will evaluate the efficacy and safety of high doses of SPN-812 ER in adolescents~     (12-17 years old)~   "
24405|NCT03247543|"~     This study will evaluate the efficacy and safety of high doses of SPN 812 ER in children with~     ADHD~   "
24406|NCT03247530|"~     This study will evaluate the efficacy and safety of low doses of SPN-812 ER in children 6-11~     years of age diagnosed with ADHD.~   "
24407|NCT03247517|"~     This study will evaluate the efficacy and safety of low doses of SPN-812 ER in adolescents~     12-17 years of age.~   "
24408|NCT03247504|"~     Cancer pain is undertreated despite a good access to opioids in France. Although many factors~     are involved, the barriers related to the patient (and his family) are often reported .the~     reluctance of the patient or the family to take the prescribed medication is linked to~     misconceptions about the opioids , cultural barriers; or the lack of explanations provided by~     the physician. Some patients can have undiagnosed slight cognitive impairment .The situation~     is now more complicated as appear on the market the new form of opioids for the cancer~     breakthrough pain drug, adding one more opioid formulation in the prescription. The goal of~     the study is to measure the adherence to opioids in cancer out patients and the associated~     factors.~   "
24409|NCT03247491|"~     The aim of this study is to assess a mindfulness and compassion group intervention for~     pregnant women and their partners (8 weeks) for the prevention, reduction and treatment of~     stress, negative affect and depression in pregnancy and breastfeeding. This group~     intervention will also be compared with a Treatment as usual (TAU) group consisting in a~     childbirth education class taught by the Health Center midwife. The principal hypothesis is~     that the mindfulness and compassion intervention will be more effective than TAU.~   "
24410|NCT03247478|"~     This is a prospective, single-center, non-randomized, non-controlled observational study.~   "
24445|NCT03247023|"~     This study will evaluate the long term performance and safety data for the Cadence™ Total~     Ankle System (CTAS) when used for primary arthroplasty in patients with primary arthritis~     (e.g. degenerative disease), secondary arthritis (e.g. post-traumatic, avascular necrosis, if~     minimally 2/3 of the talus is preserved), and systemic arthritis of the ankle (e.g.~     rheumatoid arthritis, hemochromatosis)~   "
24631|NCT03244592|"~     The objective of this proposal is to advance medication development for alcohol use disorder~     by examining the efficacy and mechanisms of action of minocycline, a neuroimmune modulator,~     as a potential treatment. This study has important clinical implications, as the available~     treatments for alcohol use disorder are only modestly effective and testing novel medications~     is a high research priority.~   "
24411|NCT03247465|"~     Aortic stenosis is one of the most common cardiology diseases. Trans aortic valve~     implantation (TAVI) has been developed since 2002, first to treat rejected patients from~     conventional surgery, then to treat high surgical risk patients and nowadays probably~     intermediate surgical risk patient. TAVI related complications are still recurrent and the~     investigators are searching a way to decrease them.~      One of them could be image fusion, since it may decrease radiation exposure and contrast~     agent use. It may also improve valve placement position leading to decreased complications.~      40 prospective and consecutive patients will be included. Participants will be divided into~     two groups: the 20 first included will be control group, the 20 following patients will be~     the fusion group. For control group TAVI procedure will be the usual one, for fusion group~     the procedure will be the usual one with addition of computed tomography 3D images fusion~     with fluoroscopy 2D images.~      Main evaluation criteria will be radiation exposure, measured by dose area product (DAP).~     Secondary evaluation criterion will be procedural as contrast agent volume used, procedure~     duration, subjective usefulness of image fusion or procedure failure evaluated immediately~     after procedure. The investigators will also evaluated procedure induced complications as de~     novo pacemaker implantation, de novo left bundle branch, vascular complication, major~     bleeding, acute kidney failure, significant aortic regurgitation. These complications~     occurrence will be evaluated after 1 month follow up, during the usual following~     consultation.~   "
24412|NCT03247452|"~     This is a single center randomized controlled trial to compare bowel cleansing for outpatient~     colonoscopy in two groups of participants: one group will receive instructions of one-day~     structured low fiber diet whilst the other group will receive three-day low fiber diet.~      Both groups will receive the same bowel cleansing solution (polyethylene glycol plus ascorbic~     acid). Bowel cleansing will be assessed according the Boston Bowel Preparation Scale.~   "
24413|NCT03247439|"~     This study will evaluate whether Cartiva is an effective treatment for individuals with~     osteoarthritis of the CMC joint in the hand compared to LRTI.~   "
24414|NCT03247426|"~     The aim of this study is to compare sleep quality, job satisfaction, quality of life,~     occupational burnout levels among individuals who do or do not do exercise.~   "
24415|NCT03247413|"~     Chronic neck and back pain has become one of the leading causes of disability and loss of~     productivity. For many patients with facet or sacroiliac joint mediated pain who have~     responded to diagnostic nerve blocks, radiofrequency ablation of the nerves innervating the~     joints can provide long term relief. Radiofrequency ablation (RFA) is a relatively safe~     procedure with minimal risk of adverse events. However, with any procedure involving damage~     to the peripheral nervous system, there is risk of post-procedure neuropathic pain. The~     investigators will test the hypothesis that dexamethasone injection delivered at the time of~     lesion effectively prevents the development of post-ablation neuritis through a~     placebo-controlled, double-blind, randomized trial in patients undergoing cervical, thoracic,~     lumbar, and sacroiliac joint radiofrequency denervations~   "
24416|NCT03247400|"~     The aim of this study is to evaluate the influence of simvastatin and atorvastatin on~     vitiligous lesions in patients with non-segmental vitiligo.~   "
24417|NCT03247387|"~     Clinical assessments can only offer a snapshot of daily life with Parkinson's Disease, while~     wearable devices can offer immensely more information that can improve the understanding of~     this disease. With recent advancements in technology, investigators are now able to use~     watch-like devices to more effectively measure the symptoms of Parkinson's Disease outside of~     the doctor's office. The present study is designed to evaluate the usability, applicability,~     and interpretability of an electronic VA Patient Motor Diary (eON-OFF), MC10 BioStampRC~     actigraphy sensor, APDM actigraphy sensor and the GENEActiv Watch in persons with Parkinson's~     Disease. There is no placebo/control group.~   "
24418|NCT03247374|"~     The primary purpose of the study is to evaluate whether the effect of bio-feedback dysphagia~     treatment is more effective than a control treatment in post-stroke patients.~      This study will be a randomized, single-blind controlled pilot study. The investigators~     intend to recruit 40 patients who have suffered a stroke and have dysphagia. Twenty patients~     will undergo training with bio-feedback (experimental group) and the other 20 patients will~     undergo standard training, using only verbal feedback rather than visual feedback (control~     group).~      The authors hypothesize that in the control group the efficacy of the treatment will be lower~     in the absence of immediate visual feedback of strength and coordination of the swallowing~     act.~   "
24419|NCT03247361|"~     It is well-known that muscle weakness and deconditioning play an important role in low~     exercise capacity of patients with HF. Interestingly, not only peripheral muscles are~     impaired, but also respiratory muscles. Studies have shown that patients with HF may have, in~     addition to decreasing maximal inspiratory muscle strength and endurance, metabolic and~     structural impairments in diaphragm fibers. Moreover, exercise capacity and weakness of~     inspiratory muscles have been associated with low quality of life and poor prognosis, which~     make the addition of inspiratory muscle training (IMT) reasonable in cardiovascular~     rehabilitation.The specifications of the loads to be imposed during IMT is the main factor~     determining the outcome. Studies of IMT have highlighted the need for a fixed inspiratory~     workload during exercise. Thus, purpose of this report was to perform a randomized clinical~     trial of the effects of addition of high-intensity vs. low-intensity IMT to combined aerobic~     and resistance Exercise in patients with heart failure.~   "
24420|NCT03247348|"~     This study evaluates the feasibility of a behavioral intervention designed to replace~     sedentary behavior with light physical activity in veterans with Fibromyalgia. The study will~     also evaluate the acceptability of the intervention among veterans and intervention effects~     on pain and physical function.~   "
24421|NCT03247335|"~     Follow-up of Arthrosurface HemiCAP shoulder implants.~   "
24457|NCT03246867|"~     The purpose of this study is to investigate and compare the acute effects of isolytic and~     static stretching training in individuals having subacromial impingement syndrome with~     glenohumeral internal rotation deficit. Isolytic group will receive isolytic stretching in~     modified cross body position. Static group will receive static stretching in modified cross~     body position. Stretching groups will be evaluated before and just after stretching exercise.~     Control group will receive no stretching. Control group will be evaluated for the first time~     and then will be waited until the duration of the stretching exercise program. Afterwards,~     second evaluation will be performed~   "
24422|NCT03247322|"~     TRANSAFE Rx is a 12-month, parallel two-arm, 1:1 randomized controlled clinical trial,~     involving 136 participants (68 in each arm) measuring the clinical and economic effectiveness~     of a pharmacist-led intervention, which utilizes an innovative mHealth application to improve~     medication safety and health outcomes, as compared to usual post-transplant care. The primary~     goal of the TRANSAFE Rx study is to demonstrate significant reductions in med safety issues~     leading to reduced healthcare resource utilization in kidney transplantation through a~     pharmacist-led, mHealth-enabled, intervention. This study will provide detailed and novel~     information on the incidence, etiologies and outcomes of med errors and adverse drug events~     in this high-risk population; while also demonstrating the effectiveness of this intervention~     on reducing the incidence and impact of med safety issues in kidney transplantation.~   "
24423|NCT03247309|"~     This clinical research study investigates IMA201 which is composed of special immune cells (T~     cells, also called T lymphocytes) being genetically modified by introduction of a~     tumor-antigen specific T cell receptor (TCR) to fight against cancer. Patients that choose to~     take part in this study have advanced cancer where there is no (further) standard treatment~     for their cancer available OR current treatments are not tolerated.~      The main purpose of this clinical research study is to confirm the safety of IMA201 and to~     define the highest safe dose of IMA201 cells to give to patients. The study will also~     investigate what the specific side effects of this treatment are, and to see whether this~     therapy shows clinical activity in patients with their advanced cancer.~   "
24424|NCT03247296|"~     To evaluate the early detection of HCC in patients Taking Sofosbuvir and Daclatasvir.~   "
24425|NCT03247283|"~     Phase 1 Phamacokinetic and metabolism study of BMS-986205 in healthy males~   "
24426|NCT03247270|"~     According to the Global Burden of Disease report in 2015, anxiety disorders are among the top~     10 contributors to years lived with disability worldwide. There is a need for effective~     treatment protocols. As cardiovascular fitness has a major impact on the brain's ability to~     change structurally and functionally, interventions involving physical exercise might prove~     positive in the treatment of persons with anxiety. Yet there are few high quality clinical~     studies with physical exercise as an intervention for anxiety disorders.~      Aims:~        1. To test a 12 week physical exercise intervention for persons treated for anxiety~          disorders within primary care. The exposure of interest is intensity of physical~          exercise; outcomes include anxiety symptom burden, cognitive ability and sick leave.~        2. To gain knowledge regarding potential mechanisms by comparing serum levels of specific~          hormones and cytokines (characterized and associated with brain plasticity in animal~          models) before and after different intensities of exercise.~      Implementation:~      Patients will be randomized into 3 groups: 1) Intervention I: 12 week exercise program with~     low-intensity fitness training 3 times per week. 2) Intervention II: 12 week exercise program~     with moderate to high-intensity fitness training 3 times per week. 3) Control group, who will~     have a physiotherapy session once and will be given general advice about physical activity.~     At baseline, 12 weeks and 1 year data of cardiovascular fitness, anxiety symptoms, cognitive~     and working ability and biomarkers will be collected.~      Impact:~      If physical exercise positively affects anxiety disorders it would have significance, for the~     patients as well as for society. In addition to increased quality of life, it may decrease~     future marginalization and premature death among individuals suffering from anxiety~     disorders. Reducing medical and sick-leave costs would also liberate health care resources to~     be used elsewhere in an economically strained health care system.~   "
24427|NCT03247257|"~     This study is a prospective, comparative, controlled, blinded study that will enroll a total~     of 70 adults that will undergo elective laparoendoscopic single-site incision gallbladder~     removal. The objective of this study is to compare Epidural versus General Anesthesia for~     postoperative pain, length of hospital stay, outcomes, and cost of post-cholecystectomy~     patients.~   "
24428|NCT03247244|"~     For many individuals with Tourette syndrome (TS), available medications do not help with~     their symptoms, or cause significant side effects. Two small controlled trials have~     investigated the effect of oral delta-9-tetrahydrocannabinol (THC), a principal psychoactive~     ingredient of cannabis, in TS patients. While these trials have shown promising results, the~     effect sizes were not as large and consistent as those reported by patients with regards to~     inhaled cannabis (smoked or vaporized). Indeed, based on anecdotal evidence, patients have~     much greater improvement in their symptoms using inhaled cannabis than using cannabinoid~     pharmaceuticals. However, there have been no controlled trials of inhaled medical cannabis~     for TS to date. Furthermore, various medical cannabis products are authorized in Canada with~     different contents of THC and cannabidiol (CBD), another primary cannabinoid. No data exists~     regarding the dosing, efficacy and safety of these products in the treatment of TS. To gather~     such data, a double-blind, randomized, crossover pilot trial will be conducted to compare the~     efficacy and safety of three vaporized medical cannabis products with different THC and CBD~     contents, as well as placebo, in adults with TS. As well, the PK/PD profile of THC and CBD of~     the products will be assessed and correlated with tic symptoms~   "
24429|NCT03247231|"~     TO ANALYSE THE EFFICACY AND SAFETY OF ENDOSCOPIC BAND LIGATION WITHOUT RESECTION IN SMALL~     GASTROINTESTINAL SUBMUCOSAL TUMORS~   "
24430|NCT03247218|"~     Symptomatic sickle cell disease (SCD) is worldwide the most frequent cause for hereditary~     hemolytic anemia with recurrent pain crises. Hemolysis, vaso- occlusive and pain crises are~     hallmarks of this disease and are causative for an important socio-economic burden worldwide,~     especially in Africa.~      Aside from allogenic stem cell transplantation, which is rarely available and very expensive,~     at present there is no curative treatment for patients with SCD. The current standard of care~     includes treatment with Hydroxyurea and symptomatic care such as transfusions,~     antibiotic/analgesic treatment. Recent findings allowed the investigators to come up with a~     novel pharmacological target for prophylactic treatment of this group of patients. The~     investigators showed that N-methyl D-aspartate receptors (NMDARs) are substantially~     up-regulated in circulating red blood cells (RBCs) of SCD patients. Ca2+ uptake via these~     non-selective cation channels has major impact on RBC hydration and facilitates~     polymerization of deoxygenated hemoglobin S variant in RBCs of patients. In vitro~     observations shows that inhibition of NMDARs with Memantine caused re-hydration and largely~     prevented hypoxia-induced sickling in RBCs. A pilot trial MemSID (NCT02615847) was conducted~     in August 2015-March 2017 at the Hematology Division of University Hospital Zurich. A small~     cohort of adult SCD patients was treated with 20 mg Memantine daily to test safety,~     tolerability and efficacy of this drug and to assess the effect of Memantine on hemolytic~     activity and RBC stability. Pilot data reveal safety and an impressive therapeutic potential~     of Memantine in treating SCD patients. Due to a small number of SCD patients in Switzerland,~     an extended trial including larger number of adult and adolescent patients will be performed~     at the Pediatric Hematology Unit of the Emek Medical Center in Afula, Israel~   "
24431|NCT03247205|"~     This pilot study will look at whether it is possible to give better physical therapy to~     people with cognitive limitations who have had a hip fracture.~   "
24432|NCT03247192|"~     The main purpose of the present study was to investigate the effects of whey protein~     supplementation associated with resistance training on muscle strength, body composition,~     muscle quality, cellular hydration, cardiometabolic risk factors, inflammatory and oxidative~     stress markers in trained elderly women and to evaluate whether the timing of protein intake~     provide different responses on these variables.~   "
24439|NCT03247101|"~     Morbid obesity has become a major global health problem, and the use of bariatric surgery is~     increasing. One common complication seen following bariatric surgery is the formation of~     gallstones. Contributing factors to gallstone formation include hypomotility of gall bladder~     and supersaturation of bile due to rapid weight loss and mobilization of cholesterol.~     Previous studies revealed oral probiotics could reduce the cholesterol level by as much as~     22% to 33%. The possible mechanisms included bile salt hydrolase activity, assimilation of~     cholesterol by the bacteria, binding of cholesterol to the bacterial cell wall and~     physiological actions of the end products of short chain fatty acid fermentation. Therefore,~     the aim of this study was to determine the ability of probiotics to prevent gallstones~     formation after bariatric surgery and to evaluate the impact of oral administration of~     probiotics on the post bariatric surgery patients 's quality of life.~      Gastrointestinal Quality of Life Index is a widely accepted questionnaire for evaluating the~     quality of life for patients receiving bariatric surgery. It consists of five domains:~     digestive symptoms; physical function; emotional condition; social condition and effect of~     medical treatment, which could access the quality of life of bariatric patient effectively~     and completely.~   "
24440|NCT03247088|"~     The goal of this clinical research study is to find the highest tolerable dose of sorafenib~     (out of 4 possible doses) that can be given in combination with busulfan and fludarabine~     before an allogeneic stem cell transplant and alone after the transplant. Researchers also~     want to learn if this combination can help to control acute myeloid leukemia (AML). The~     safety of this drug combination will also be studied.~      This is an investigational study. Sorafenib is FDA approved and commercially available for~     use in solid tumors. Its use alone after a stem cell transplant and in combination with~     busulfan and fludarabine before a stem cell transplant is investigational. Busulfan and~     fludarabine are FDA approved and commercially available for use in stem cell transplantation.~      The study doctor can explain how the study drugs are designed to work.~      Up to 60 participants will take part in this study. All will be enrolled at MD Anderson.~   "
24441|NCT03247075|"~     Social anxiety disorder among youth is highly prevalent and causes significant impairment in~     the lives of the affected. In spite of cognitive behavior therapy (CBT) being an effective~     treatment, research suggests that many young people with this disorder do not have access to~     good-quality CBT. Internet-delivered CBT could be an effective method to increase~     availability of evidence-based treatments for youth with social anxiety disorder. The primary~     objective of this study is to test the efficacy of internet-delivered CBT (ICBT) for youth~     (10 - 17 years) with social anxiety disorder. The investigators aim to conduct a randomized~     controlled trial with N = 101 participants. Participants will be randomized to either the~     active treatment arm (guided ICBT) or to a control condition (guided internet-delivered~     support and counseling). Follow-ups will be conducted at 3 and 12 months after~     post-assessment.~   "
24442|NCT03247062|"~     Summary of the project :~      Lack or disturbances of sleep are major problems in patients staying in intensive care unit~     (ICU) due to the particular environment. The noises, lack of circadian rhythm of light lead~     to progressive deafferentation. The patients are then at risk of immune deficiencies,~     agitation and confusion states, cognitive troubles that may be associated to increased~     morbidity and mortality in the short and long term. Thus, improvement of the sleep of the ICU~     patients may impact non only during the ICU stay but also on their future quality of life.~      The sleep bundle project is a quality improvement project with a before-after design,~     consisting in the evaluation of a bundle of measures that may increase the quality and~     duration of sleep in ICU patients.~      The bundle consists in the proposition of eye-mask, ear-plugs, music and/or massage to the~     patients in parallele to structural and organizational modifications of the service such as~     the decrease of the alarms sounds, changing the luminosity between day and night, etc.~      The principal indicators followed will be:~        -  The sleep quality of the patients~        -  The continuous noise intensity in the rooms~        -  The continuous light intensity in the rooms Baseline - before period: 8 weeks~          Implementation of the bundle with training of the team: 4 weeks After period: 8 weeks.~   "
24443|NCT03247049|"~     The clinical evidence shows that patients with a first episode of intracerebral hemorrhage~     (ICH) are increasingly old and with greater comorbidity with a recognized impact over~     mortality. The prediction of the outcome of ICH is not only crucial in the emergin attention~     to identify those patients with favorable criteria that can benefit from possible treatments;~     but also after hospital discharge, in primary care where the prediction should facilitate the~     organization and management of a wide variety of resources: familiar, health and social~     welfare. Even though there are different scales that predict mortality, these are not~     sufficiently useful in choosing a treatment or do not provide sufficient data to the family~     to decide.~      Due to the characteristics of the population with ICH described in these works, it seems~     useful to propose a prognostic index (ICHCat) to identify the variables associated to its~     incidence and mortality and that, in addition, to make adjustments in the comparisons of the~     survival between different series of patients or different treatment modalities in primary~     care.~   "
24444|NCT03247036|"~     A number of large trials have confirmed the benefits of thrombolysis in acute stroke, but~     there are gender differences. The authors sought to examine the relationship between sex and~     outcome after thrombolysis.~      Previous reports [1-6] concerning sex-related differences in stroke management and outcome~     are inconsistent and sometimes difficult to interpret, and so the reasons for gender~     disparities in stroke outcome have remained unclear. Functional outcomes and quality of life~     after stroke are consistently poorer in women despite adjustment for baseline differences in~     age and prestroke function, and the fact that comorbidities and clinical outcomes were not~     different between women and men [3, 7] . Once the reasons for these differences are better~     understood, intervention might be possible to help provide the best care for all patients.~     This work is a continuation and extension of the Ebrictus Study [8-10] . Prior work has~     suggested sex-based differences in thrombolytic therapy in subjects with acute stroke [11]~     .The authors will explore whether sex might modify the effect of thrombolysis on survival and~     functional outcomes in patients with acute ischemic stroke [12] beyond the usually evaluated~     time period of 6 months after stroke and compared this with the group without thrombolytic~     treatment.~   "
24458|NCT03246854|"~     The study is being performed to assess the MTD, pharmacokinetics (PK), safety, tolerability~     and preliminary antitumor activity of DBPR112 in patients with head and neck cancer and EGFR~     mutated lung cancer.~   "
24446|NCT03247010|"~     Radium-223-dichloride is approved therapy for patients with metastatic castration-resistant~     prostate cancer and bone metastases. Therapy is administered intravenously every 4 weeks for~     up to 6 cycles. More than 20 % of patients treated at Rigshospitalet develop bone marrow~     suppression as a side effect to Radium therapy, which delays or excludes the patient from~     further oncological therapy. Especially thrombocytopenia is a frequent side-effect and can be~     long lasting.~      The aim of the study is to examine whether biomarkers of bone marrow recovery (immature~     platelets, platelet volume, reticulocytes, red cell distribution width) can predict~     development of hematological toxicity during Radium therapy. Furthermore, to investigate~     whether these biomarkers can predict recovery from toxicity in patients who develop bone~     marrow suppression during therapy.~   "
24447|NCT03246997|"~     Project Powerfood is a pilot program aimed at addressing food insecurity and food access in~     primary care through the implementation of a food prescription program in collaboration with~     a number of community partners. The objectives of this project are:~        1. Implement screening for food insecurity in adult and pediatric primary care practices at~          Mount Sinai.~        2. Provide fresh fruit and vegetable prescriptions to be redeemed for farm shares from~          local partner, the Corbin Hill Food Project. Prescriptions will provide 50% off of a~          fruit and vegetable box. Participants will have the option to purchase 2 boxes per month~          for 6 months.~        3. Pilot prescriptions with 50 adult patients with poorly-controlled diabetes and 50 obese~          children who are food insecure and/or receive SNAP and/or WIC benefits.~          Examine/evaluate:~             1. Feasibility of program in a busy primary care practice~             2. Outcomes before and after the intervention (at baseline, 6 and 12 months),~               including diet, diabetes control, and body mass index (BMI)~             3. Outcomes in a comparison group (that will receive the food prescriptions beginning~               at 6 months)~   "
24448|NCT03246984|"~     This is a prospective single arm study enrolling patients who are scheduled for creation of a~     new Brachiocephalic AV fistula. Up to 50 patients will be enrolled. All patients will be~     implanted with the VasQ device, a subcutaneous arteriovenous conduit support for vascular~     access. The follow up period in this study will be for a duration of 12 months, with follow~     up visits scheduled at 1, 3, 6, 9, and 12 months.~   "
24449|NCT03246971|"~     This study evaluates the safety and effectiveness of Wafermine™ for post-bunionectomy or~     post-abdominoplasty pain over a 24 hours period. For subjects undergoing bunionectomy, 2 out~     of 3 subjects will receive Wafermine™ and 1 out of 3 subjects will receive placebo. For~     subjects undergoing abdominoplasty, 3 out of 4 subjects will receive Wafermine™ and 1 out of~     4 subjects will receive placebo.~   "
24450|NCT03246958|"~     This research study is studying nivolumab, an investigational drug, in combination with~     ipilimumab, also an investigational drug, as a possible treatment for thyroid cancer.~      The drugs involved in this study are:~        -  Nivolumab (Opdivo™)~        -  Ipilimumab (Yervoy™)~   "
24451|NCT03246945|"~     Advances in smart phone-based photography (both quality and image transmission) offer the~     potential to greatly improve access to pediatric dermatologists. However, the accuracy of~     diagnoses reliant on parent-provided photographs has been neither measured nor compared to~     diagnoses based on in-person examinations. Therefore, the primary objective of this study was~     to assess the concordance between diagnoses based on photographs taken by parents (or legal~     guardians) and those based on in-person examinations. A secondary aim was to assess the~     effect of photography instructions on improving this concordance.~   "
24452|NCT03246932|"~     Profession-led psycho-education programs for people with schizophrenia are evidenced to~     improve patients' knowledge about the illness, mental state and relapse rate. Nevertheless,~     other benefits to patients, for example, their functioning and insight into illness or to be~     substantive in a longer term (>12 months) are inconsistent and uncertain, especially in Asian~     populations. This single-blind multi-site randomized clinical trial was to test the effects~     of a peer-expert-led psycho-education group intervention (in addition to usual care) for~     adult patients with schizophrenia spectrum disorders over a 24-month follow-up, in comparison~     to a profession-led psycho-education group or treatment-as-usual only.~   "
24453|NCT03246919|"~     This study will evaluate if the timing of oxytocin administration in cesarean deliveries will~     affect the amount of maternal blood loss. Half of participants will receive oxytocin after~     delivery of the fetal anterior shoulder and the other half will receive oxytocin after~     delivery of the placenta. We hypothesize that administering oxytocin after delivery of the~     shoulder, will result in less overall maternal blood loss.~   "
24454|NCT03246906|"~     This randomized phase II trial includes a blood stem cell transplant from an unrelated donor~     to treat blood cancer. The treatment also includes chemotherapy drugs, but in lower doses~     than conventional (standard) stem cell transplants. The researchers will compare two~     different drug combinations used to reduce the risk of a common but serious complication~     called graft versus host disease (GVHD) following the transplant. Two drugs, cyclosporine~     (CSP) and sirolimus (SIR), will be combined with either mycophenolate mofetil (MMF) or~     post-transplant cyclophosphamide (PTCy). This part of the transplant procedure is the main~     research focus of the study.~   "
24455|NCT03246893|"~     Post extubation respiratory failure occur in 30% of extubated patients. More than 50% of them~     required reintubation. Noninvasive positive pressure ventilation (NIV) had been reported as~     an effective tool to prevent post extubation respiratory failure. Recently, high flow oxygen~     nasal cannula (HFNC) had been successfully used to prevent post extubation respiratory~     failure and prevent reintubation in comparable with NIV among post cardiothoracic surgery and~     high risk for reintubated patients. There was no information about HFNC versus NIV in~     prevention of reintubation among severe sepsis or septic shock patients.~   "
24456|NCT03246880|"~     A Multicenter, Randomized, Double-blind, Active-controlled, Parallel group, Phase III~     Clinical Trial To Evaluate the Efficacy and Safety of CKD-397 in Benign Prostatic Hyperplasia~     Patients.~   "
24578|NCT03245281|"~     The purpose of this non-randomized, cross-over, unblinded, single-center feasibility study is~     to assess the sensitivity of the LINQ ICM to measure derived-subcutaneous impedance in~     patients with heart failure during periods when diuretics and/or HF-medication consumption is~     increased or suspended for 48 hours (up to 72 hours at physician discretion) and to collect~     safety information related to HF status and to medication consumption changes.~   "
24459|NCT03246841|"~     TUMOSPEC is a national family study designed to measure the relative and absolute risk of~     cancer for carriers of deleterious mutations to these new breast cancer (BC) susceptibility~     genes. Index cases will be enrolled consecutively from patients attending an appointment at~     one of the Unicancer centres, with no other inclusion criteria, and offered a BRCA1/2~     analysis as part of their care plan. A panel of 24 TUMOSPEC genes, chosen in advance by a~     steering committee, will be tested as the same time as the BRCA1/2 genes, at one of the usual~     BRCA1/2 analysis laboratories belonging to the same network and participating in the study.~     If a mutation is found, the index cases will be asked to invite their first and second degree~     family members and their cousins to take part in the study, regardless of whether they have~     cancer. Saliva samples will be then taken and used for a targeted analysis of the familial~     abnormality. Each participant will also complete an epidemiological questionnaire in order to~     gather information about his/her medical history and any exposure to various risk factors.~     All medical and genotype data will be centralised at the Genetic Epidemiology Research~     Platform (PIGE, INSERM). The cumulative mutation frequency for all genes is estimated at 10%.~     Penetrance will be analysed using methods designed to minimise selection bias. The expression~     spectrum of the mutations will also be described. For genes where the number of mutated~     families is too low, the data may be contributed to international consortia. The main project~     will be preceded by a two-year feasibility study, using the same inclusion criteria and~     logistic circuits. It is this pilot study to which the current funding application relates.~   "
24460|NCT03246828|"~     The aim of this study is to determine whether fasting and post-prandial glucagon secretion is~     suppressed by gliclazide in patients with HNF1-/4-alpha MODY. Participants will undergo an~     oral glucose tolerance test (OGTT) before and after omitting their gliclazide medication for~     3 days.~   "
24461|NCT03246815|"~     National guidelines have recommended routine STD screening (chlamydia and gonorrhea) for~     sexually active young women under the age of 25. Despite these recommendations, many young~     women are not being screened for STDs, with some estimates that less than 50% of women~     receiving health care are screened for chlamydia. Untreated STDs can lead to important~     sequelae to women's reproductive health including pelvic inflammatory disease, infertility~     and ectopic pregnancy. One of the most important barriers to widespread STD screening is~     provider failure to recognize an opportunity for STD screening. The goal of this study is to~     determine whether offering STD screening (chlamydia and gonorrhea) by a non-physician member~     of the medical practice (who receives an automated alert indicating STD screening should be~     offered) will be associated with a higher rate of STD screening in young women attending~     primary care practices compared to usual care (where a physician offers screening with no~     electronic alert). This study will be performed in UPMC-affiliated primary care practices~     (Family Practice, Internal Medicine, OB/GYN, Pediatrics). Practices will be assigned to the~     intervention or usual care. The intervention will be an auto-task in the electronic medical~     record to the non-physician/NP/PA medical staff (medical assistants, LPNs, RNs) to offer~     chlamydia and gonorrhea screening via urine or self-collected vaginal sampling, in an opt-out~     manner, to eligible women. Practices assigned to the usual care group will not have the~     intervention. STD screening rates (# women undergoing STD screening/# eligible women) will be~     compared between the to groups (intervention practices and control practices). Results of~     this study may be important to guide national STD screening recommendations and will address~     critical barriers to widespread STD screening.~   "
24462|NCT03246802|"~     A dose-response relationship for radiation in the management of prostate cancer is well~     established. Local recurrence of prostate cancer after external beam radiotherapy occurs in~     at least 40% of patients treated because of inability to deliver sufficient dose through~     external beam techniques. These patients respond well to re-irradiation using brachytherapy~     with about 50% of selected patients remaining free of recurrence 5 years after salvage.~     Advanced imaging using multiparametric Magnetic Resonance Imaging (mpMRI) allows~     identification of the site of recurrence, permitting partial prostate salvage brachytherapy.~     There is extensive literature on Low Dose Rate salvage brachytherapy but less on High Dose~     Rate.~   "
24463|NCT03246789|"~     The purpose of this study is to test the feasibility of two types of group therapy sessions.~     The research is being done because the researchers are trying to learn if these approaches~     could be used by therapist in the community social service agencies to treat older adults~     with depression. There are two study groups. One group is a form of group therapy called~     Engage-M, which encourages subjects to engage in physical and social activities that they~     find pleasurable or rewarding. One group is another form of group therapy called, Wellness~     in Mind and Body, which focuses on education and de-stigmatization of health and mental~     health conditions.~   "
24464|NCT03246776|"~     The clinical study of the microbial colonization of chronic keratinized hand eczema and the~     change of microbial colonization after external using of Halometasone Triclosan Cream~   "
24465|NCT03246763|"~     Current obesity treatment guidelines recommend 26 or more hours of behavior treatment,~     delivered over a 6-month period in a multidisciplinary weight management clinic. However,~     this guideline is not feasible in real-world clinic settings where medical visits are costly~     and poorly reimbursed, and attrition is high, particularly among the most vulnerable~     children. The National Collaborative on Child Obesity Research has issued a call for research~     investigating healthcare-community partnerships to improve the effectiveness of child obesity~     treatment. The World Health Organization supports this approach, and in 2015 modified the~     chronic disease model to include healthcare-community integration. Arches is a three-year~     project that will develop and evaluate an effective, engaging, and scalable~     community-healthcare treatment option for low-income and racially diverse children. The~     project engages four communities in North Carolina and facilitates a local clinic-community~     partnership, supports the development of an integrated childhood obesity treatment program,~     and evaluates the feasibility of the integrated program model. The effectiveness of the~     integrated model will also be evaluated, as we will monitor patient outcomes associated with~     participation.~   "
24500|NCT03246295|"~     Gestational diabetes mellitus (GDM) has many adverse effects on pregnant women and fetuses.~     At present, no prediction marker for GDM in early pregnancy is accepted. There is still a~     lack of recognized early predictors. This study was designed to identity valuable biomarkers~     for GDM.This was a prospective observed cohort study. 140 pregnant women were recruited in~     early pregnancy, and followed up to 6 weeks postpartum. Glucose challenge test and 75g oral~     glucose tolerance test were performed after 24 weeks of pregnancy, and GDM was diagnosed~     according to the latest ADA standard. Urinary samples were collected in the first (<12~     weeks), second (24~28 weeks) and third (32~weeks) trimester of pregnancy. Urinary proteomics~     and metabolomics were analyzed by ultra-performance liquid chromatography tandem mass~     spectrometry. 15 cases of GDM women and 50 cases of control women were used for longitudinal~     analysis; 15 cases of GDM women and 15 cases of age matched control women were used for~     difference analysis.~   "
24466|NCT03246750|"~     Study Title: Phase I/II study of brentuximab vedotin and methotrexate/ L-asparaginase/~     dexamethasone (B-MAD) chemotherapy in patients with newly-diagnosed Extranodal NK/T-cell~     Lymphoma~      Phase: I/II~      Number of Patients: 36~      Study Objectives~      Primary~        -  To determine the safety and optimal dose of brentuximab vedotin when use in combination~          with methotrexate, L-asparaginase and dexamethasone in the treatment of newly-diagnosed~          ENKTL patients~      Secondary~        -  To evaluate the clinical efficacy of this regimen~        -  To access the overall responses including overall response rate (ORR), disease-free~          survival (DSF), progression-free survival (PFS).~      Overview of Study Design:~      Open-label, multicenter, non-randomized, 3+3 dose escalation study of brentuximab vedotin in~     combination with fixed-dose MAD chemotherapy. The first cycle will be evaluated for the~     determination of the recommended phase II dose.~      Patients will be received the treatment according to the stage of disease as follows:~        -  Patients with localized ENKTL (stage IE or stage IIE) will receive involved-field~          radiation (IRFT) with concomitant weekly intravenous Cisplatin. Three to five weeks~          after the completion of IFRT and cisplatin, B-MAD (Brentuximab vedotin, Methotrexate,~          L-asparaginase and Dexamethasone) regimen will be given every 21 days for 3 cycles.~        -  Patients with advanced ENKTL (stage III or stag IV) will receive B-MAD every 21 days for~          6 cycles.~      Study Population:~      Patients with newly-diagnosed ENKTL will be screened for enrollment.~      Duration of Study: 3 years~   "
24467|NCT03246737|"~     Multiple cardiovascular adaptations happen during pregnancy. When gestational hypertensive~     disorders (GHD) occurs, these adaptations are abnormal. Approximately 5 - 8 % of all pregnant~     women develop GHD.~      GHD is an pregnancy complication which is characterized by an elevated blood pressure (≥~     140/90 mm Hg) and sometimes the appearance of proteinuria (≥3 g/ 24 hours) after twenty weeks~     of pregnancy. When this remains uncured, GHD can have severe complications for both mother~     and child. For this reason, a close follow-up of women with a high risk for developing this~     condition is recommended. This to detect and threat GHD early.~      Patients can be included when they are at least 10 weeks pregnant. Every pregnant women~     receives two devices to control daily here parameters in her home environment: a blood~     pressure monitor and an activity tracker. The women will be asked to perform two blood~     pressure measurements a day and to wear the activity tracker day and night. This data will be~     send by Bluetooth and Wi-Fi to the investigator in the hospital. Also will the women be asked~     to measure once a week her weight and send this to the hospital.~      Name of the device Measurement Protocol Blood pressure monitor Blood pressure, heart rate~     Twice a day (morning and evening) Activity tracker Activity- and sleep pattern Day and night~     Weight scale (not remote) Weight Once a week (morning)~      The investigator controls daily the incoming measurements and consults the responsible~     gyneacologist when events (= abnormal blood pressure or weight measurement) occurs. Depending~     on the decisions of the gyneacologist, following actions can be performed:~        -  Further observations~        -  Extra monitor~        -  Adjustments to the medication scheme~        -  Performing an 24 hours urine collection~        -  Admission to the prenatal observation ward When results are missing, the investigator~          contacts the women to ask of this measurement is due to personal or technical causes.~      The purpose of this study part is to detect early signs of PE.~      When patients gave birth, the data about the delivery (duration of labour, complications,~     mode of delivery, date of delivery, complications, parameters of the mother, specialties) and~     the neonate (gestational age, date and hour of birth, Apgar score, birth weight, length,~     complications and admission to the neonatal intensive care) will be collected. These data~     will be compared to the data of women who were admitted to the hospital for GHD, but who~     doesn't receive remote monitoring devices.~   "
24468|NCT03246724|"~     The purpose of this study is to evaluate patient satisfaction after eye surgery when given a~     capsule compared to an intravenous (IV) dose of sedation (calming medication).~      Each subject will be given a capsule and an IV in the hospital before their procedure starts,~     however they will not know which one is the sedation route. Each subject will have their~     planned surgical procedure as previously discussed with their doctor. After the procedure is~     completed, the doctors will complete satisfaction surveys. The subject will also complete a~     satisfaction survey during their regularly scheduled visit the day after surgery. Once the~     subject completes this survey, their study participation will be complete.~      The hypothesis is that there will be no difference in patient satisfaction when given a~     capsule in comparison to IV sedation. If the results of the study support this hypothesis, a~     capsule could be used in place of IV sedation. By using a capsule for ocular procedures, both~     patients and the medical practice would benefit: patient would be able to eat before their~     procedure, patient costs would be decreased, hospital costs would be reduced, and some of~     these procedures would be given the option to move to a procedure room (freeing up operating~     room time for other departments).~   "
24469|NCT03246711|"~     Prospective comparative cohort study including 159 pregnant women at the third trimester~     recruited from the antenatal clinic at EL-Demerdash outpatient clinic, and followed up during~     the holy month of Ramadan (from 18th June To 16th July 2015).~      The patients recorded their pattern of fasting during Ramadan then grouped into three groups~     A, B, C regarding fasting state A- Non fasting group B- Partially fasting group C- Totally~     fasting group~   "
24470|NCT03246698|"~     The purpose of this study is to investigate and compare the effect of isolytic and static~     stretching training in individuals having subacromial impingement syndrome with glenohumeral~     internal rotation deficit. Isolytic group will receive isolytic stretching in modified cross~     body stretching position and standard physiotherapy program. Static group will receive static~     stretching in modified cross body stretching position and standard physiotherapy program.~     Control group will receive only standard physiotherapy program.~   "
24471|NCT03246685|"~     Objective: To determine the Overall Response Rate (ORR) to Imprime PGG + pembrolizumab in~     subjects with advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) Safety: To~     characterize the safety of Imprime PGG + pembrolizumab given in combination Hypothesis:~     Restore (for subjects who have failed pembrolizumab mono therapy) or enhance (for subjects~     who actively experiencing SD) sensitivity to checkpoint inhibitors (CPI) by appropriate and~     effective stimulation of the subject's innate and adaptive immune systems by combining~     Imprime PGG with pembrolizumab.~      The study will require documenting at least 5 objective responses among the 38 subjects~     enrolled who have failed prior pembrolizumab monotherapy and at least 17 objective responses~     among the 49 subjects enrolled who are actively experiencing stable disease following at~     least 4 cycles (but no more than 8 cycles) of pembrolizumab monotherapy.~   "
24472|NCT03246672|"~     Although bariatric surgery is highly effective for inducing significant weight loss and~     resolution of comorbidities, weight regain following surgery is a common problem. This pilot~     study will test the feasibility and acceptability of an intervention designed to help~     bariatric surgery patients maintain weight loss. Findings from this pilot will provide the~     foundation for a randomized controlled trial to evaluate the efficacy of the intervention.~   "
24800|NCT03242395|"~     PRIME aims to demonstrate through neurocognitive assessment that BICU patients will have a~     degree of neurocognitive dysfunction following a major burn, that this neurocognitive~     dysfunction is due to an underlying neuroinflammatory process by fMRI neuroimaging~     techniques, and that the neurocognitive deficit is associated with a reduced quality of life.~   "
24473|NCT03246659|"~     The study is a phase I multicentre randomized, open, parallel-arm clinical trial conducted to~     investigate the IMP, namely 111In-CP04.~      The study consists of preclinical (to establish a clinically useful formulation for the~     radiolabelled peptide CP04), and a clinical step. The main objective of the clinical part of~     the project is to establish the safety of i.v. administration of a high peptide amount and to~     assess the tracer biodistribution and dosimetry in MTC and normal tissues and to determine~     critical organs as well as the evaluation of the potential of CCK2 receptor scintigraphy to~     detect cancer lesions for both low (10ug) and high (50ug) peptide amount and the decrease of~     kidney dose after co-administration of gelofusine /gelaspan as a nephroprotective agent. To~     achieve this, the following study design has been accepted: the first 4 patients will receive~     2 peptide amount of CP04: low peptide amount (for diagnostic purpose) and high peptide amount~     (for therapeutic purpose) of CP04. If no SAE is present, the remaining pts will be randomized~     for 2 arms: high peptide amount of 111In-CP04 with and without gelofusine/gelaspan infusion.~      It is expected that CCK-2/gastrin receptor imaging will become a valid diagnostic method for~     a specific non-invasive staging and follow-up of patients with MTC, and treatment of~     recurrent and disseminated disease will be more efficient with minimized nephro- and~     myelotoxicity (if 111In labelled).~   "
24474|NCT03246646|"~     This project will develop and pilot test an enhanced, telephone coaching intervention to~     help family members concerned about a Veteran of the wars in Iraq or Afghanistan who needs to~     seek treatment for a substance abuse problem.~   "
24475|NCT03246633|"~     The aim of this study is to assess a novel educational mobile and online application which~     will use images of pigmented skin lesions with question prompts to train future medical~     providers to more accurately detect malignant lesions.~      The hypothesis of this study is that this new educational tool will result in higher melanoma~     detection rates among future providers.~   "
24476|NCT03246620|"~     The purpose of this study is to determine whether oral olanzapine is safer (fewer adverse~     events) and more effective (shorter time to sedation) than conventional haloperidol or~     diazepam when used in the management of acute agitation in the emergency.~   "
24477|NCT03246607|"~     This study evaluates the validity of an intravascular continuous glucose monitoring~     microdialysis probe, and compares the values to routinely inserted cerebral glucose~     microdialysis to evaluate the hypothesised relationship between intracranial and~     intravascular glucose levels.~   "
24478|NCT03246594|"~     The Trial will evaluate the influence of oesophageal probes in Radio frequency (RF)-ablation~     of atrial fibrillation regarding oesophageal ulcers after ablation.~   "
24479|NCT03246581|"~     The purpose of this study is to compare the absorption of a test inhalation product with the~     reference product in healthy volunteers.~   "
24480|NCT03246568|"~     Atrial fibrillation (AF) is the most common arrhythmia and it is associated with significant~     morbidity and mortality. Electrical isolation of the pulmonary vein (PVI) by radiofrequency~     energy or cryoablation has been shown to be an effective treatment of AF by reducing~     morbidity, improving quality of life and functional capacity.~      Renal artery sympathetic denervation (RND) by catheter ablation has been shown in a~     preliminary study to improve outcome of PVI in patients with paroxysmal and/or persistent AF~     with concomitant refractory or moderate hypertension. In patients with renal impairment, RND~     also conferred benefit in reducing AF recurrence after PVI. The initial indication for~     catheter-based RND is for blood pressure control in patients with resistant hypertension.~     However, a recent study failed to show significant difference in blood pressure reduction by~     RND. Therefore, the effect of RND on AF suppression may be independent of blood pressure~     control. Possible mechanisms of RND on AF may include risk factors modification and~     anti-arrhythmic effect.~   "
24481|NCT03246555|"~     The objective of this study is to confirm the noninferiority of the blood pressure lowering~     effect of fimasartan and evaluate its safety compared to perindopril in the elderly with~     essential hypertension.~   "
24482|NCT03246542|"~     HELLP syndrome is a life-threatening obstetric complication usually considered to be a~     variant or complication of pre-eclampsia. And may occasionally be confused with other~     diseases complicating pregnancy such as acute fatty liver of pregnancy, gastroenteritis,~     hepatitis, appendicitis, gallbladder disease, immune thrombocytopenia, lupus flare,~     antiphospholipid syndrome, hemolytic-uremic syndrome, thrombotic thrombocytopenic purpura,~     and nonalcoholic fatty liver disease. The distinction between thrombotic thrombocytopenic~     purpura-hemolytic uremic syndrome and severe preeclampsia is important for therapeutic and~     prognostic reasons. However, the clinical and histological features are so similar that~     establishing the correct diagnosis is often difficult; furthermore, these disorders may occur~     concurrently.~   "
24483|NCT03246529|"~     A total of 207 subjects will be randomized into the study which will employ a double-blind~     placebo-controlled setting to assess the efficacy and safety of G-CSF + BL-8040 as compared~     to G-CSF + placebo.~   "
24484|NCT03246516|"~     This study evaluates the role of socioeconomic and individual factors in the onset of the~     first symptoms of cancer and the first consultation with a doctor (patient delay) in~     oeso-gastric cancer.~   "
24485|NCT03246490|"~     This study aims to develop a phone app to assess gait differences at different levels of~     alcohol intoxication.~   "
24486|NCT03246477|"~     Background Maxillomandibular advancement surgery (MMA) has demonstrated high success rates,~     improving both the apnea-hypopnea index and associated patient' quality of life (QOL), in~     patients diagnosed with obstructive sleep apnea syndrome (OSAS). However, clinical relapse~     has been described in the target population, especially when associated with significant~     weight gain. Literature reporting the long-term impact of MMA for OSAS is lacking. The~     surgeons of the Division of Maxillofacial Surgery already started to perform this type of~     surgery in 1995.~      Objectives The investigators aim to evaluate the long-term (minimum 15 years post-surgery)~     biologic and QOL impact of MMA in patients with OSAS. The biologic impact refers to the~     stability of hard and soft tissues and polysomnographic results.~      Study design Retrospective study Both pre- en postoperative clinical imaging, polysomnography~     and quality of life questionnaires will be retrieved from all patients that were surgically~     treated with an MMA by one surgeon (CDC) between 01/11/1995 and 01/12/1999.~      Conclusion Short-term data have shown high success rates for MMA in OSAS patients. However,~     long-term data are lacking. This retrospective study might provide us with more information~     about the incidence of clinical relapse fifteen to twenty years after surgery.~   "
24487|NCT03246464|"~     Myopia is a common disease of the eye with increasing prevalence in the Western World as well~     as in South East Asia where 60-90% of the children are affected. High myopia is associated~     with an increasing risk of sight threatening complications such as retinal detachment,~     glaucoma, macular choroidal degeneration and myopic choroidal neovascularization. In myopia~     the eye is elongated compared to an emmetropic eye. If the elongation of the eye can be~     controlled the progression of myopia can be controlled. Asian studies have shown reduction in~     axial length growth by 36-46% in children using orthokeratology contact lenses (OKL). OKL are~     custom fit, form stable lenses. During sleep the cornea is reshaped creating an emmetropic~     vision during the day, so no glasses or contact lenses are needed. Twin and family studies~     have shown a high heritability for the development of myopia, and more than 40 genetic loci~     have been identified indicating that the effect of OKL in Asian children might not be the~     same in North European children which is why we want to execute a similar study on North~     European children.~      Purpose:~        1. Investigate if nightly wear of OKL reduces the progression of childhood myopia (change~          in axial length) in Danish children when compared to a control group using monofocal~          glasses.~        2. Investigate the safety (Efron score) of OKL.~        3. Investigate children's quality of life impact of refractive correction (questionnaire)~          using OKL compared to glasses.~        4. Identify possible predictors for progression of myopia (AC/A ratio, peripheral defocus~          and higher order aberrations).~      Method:~      A randomized controlled 18 months prospective 1:1 study of a group of Danish children. 50~     children will be included; 25 in each group. The participants will undergo several~     measurements reflecting the anatomy and function of the eye at baseline, 6, 12 and 18 month~     to evaluate the effect.~   "
24488|NCT03246451|"~     Delineation of the role of glucagon-like peptide-1 receptor signalling in the~     glucose-lowering effect of metformin during meal ingestion in patients with type 2 diabetes.~   "
24489|NCT03246438|"~     This pilot study is a 3-arm randomized control trial assessing the effectiveness of~     sequential or active choice in CRC (colorectal cancer) screening outreach vs. colonoscopy~     outreach only, in patients between 50-74 years old, who have received care at the University~     City or Valley Forge CCA (Community Care Associates) practices, are due for screening, and~     are asymptomatic for CRC. The three arms are: Arm 1: Direct schedule colonoscopy (Control),~     Arm 2: Direct schedule colonoscopy followed by mailed FIT(Fecal Immunochemical Test)~     (Sequential Choice), and Arm 3: Choice of direct schedule colonoscopy or mailed FIT (Active~     Choice).~   "
24490|NCT03246425|"~     Mechanical ventilation has been known to produce changes in the flow of blood through the~     major blood vessels in the body. These changes may go undetected, but with continuous~     arterial blood pressure measurements, changes in the arterial waveform can be visualized.~     Although we know that these arterial pressure variations occur during mechanical ventilation,~     little is known about the effects of various modes of mechanical ventilation on these~     changes. The most common modes of ventilation used in ICU are Volume control, Pressure~     control and Airway pressure release ventilation.~      Objective We have designed a prospective randomized pilot study to determine the effects of~     the commonly used ventilator modes on the arterial pressure.~   "
24491|NCT03246412|"~     The study investigates if a computer-based clinical decision support tool for skin cancer may~     improve the diagnostic accuracy of general practitioners (GPs). The aim of the program is to~     help GPs increase their diagnostic accuracy, in particular regarding the selection of~     suspicious skin lesions that need biopsy or referral to specialist health care for further~     assessment. Half of the physicians in the trial will have the clinical decision support tool~     available during consultations, while the other half has no such tool available. We~     hypothesize that general practitioners using the clinical decision support tool will have a~     higher number of correct classifications of skin lesions compared to doctors without the~     tool.~   "
24492|NCT03246399|"~     SM04690-DDD-01 is a Phase 1, open-label, dose escalation study. SM04690 Injectable Suspension~     will be administered via a single intradiscal injection to subjects with degenerative disc~     disease (DDD) under fluoroscopic guidance. Groups of 6 subjects will be enrolled in~     successive cohorts. Subjects will participate in a 6 month follow-up period. Clinic visits~     will be Screening, Treatment Visit Day 1, and Follow-up Visit Days 2, 15, 28, 60, 90, 135,~     and 180.~   "
24493|NCT03246386|"~     Although posaconazole is approved for the prophylaxes and treatment of invasive fungal~     infections, specific dosing guidelines for posaconazole in (morbidly) obese patients are not~     specified. There is clear evidence indicating that heavier patients are receiving a~     sub-optimal dose if the current guidelines are used. Specifically in the setting of augmented~     prevalence of species with intermediate susceptible to posaconazole, adequate dosing is~     needed at start of treatment.~      Therefore it seems prudent to conduct a trial in a cohort of obese patients who receive~     posaconazole (300mg or 400mg) and define the pharmacokinetics. These will then be compared to~     the pharmacokinetics in a normal-weight group receiving 300mg posaconazole.~   "
24494|NCT03246373|"~     This study observed the relationship between cerebral collateral circulation and the~     prognosis of leukoaraiosis in high-risk population. Cerebral collateral circulation and~     leukoaraiosis levels will be evaluated and followed up by magnetic resonance examination. The~     participants' clinical performance caused by leukoaraiosis will be assessed by a series of~     scales.~   "
24495|NCT03246360|"~     Our objective is to establish pharmacological equivalence of intermittent and continuous~     infusion of cloxacillin during methicillin-susceptible Staphylococcus aureus (MSSA) bone and~     joint infections (BJI). Twelve patients suffering MSSA BJI will receive both administration~     modalities and serum concentrations of cloxacillin will be determined after 3 days of II and~     3 days of continuous infusion in a prospective, randomized, open-label, monocentric crossover~     study design.~   "
24496|NCT03246347|"~     This is a study with the combination of androgen deprivation therapy (ADT) and docetaxel with~     the addition of enzalutamide in the treatment of subjects with metastatic prostate cancer.~     The purpose of this study is to assess if ADT + docetaxel + enzalutamide is well tolerated~     and demonstrates improved efficacy compared to ADT + docetaxel.~   "
24497|NCT03246334|"~     Due to advances in critical care medicine, more patients survive their critical illness.~     However, intensive care unit (ICU) survivors often experience long-term physical, cognitive~     and mental problems, summarized as post intensive care syndrome (PICS), impacting their~     health related quality of life (HRQoL). In what frequency PICS occurs, and to what extent~     this influences ICU survivors' HRQoL, is mostly unknown.~      The aims of this study are therefore to study the: 1) five-year patient outcomes, 2)~     predictors for PICS, 3) ratio between HRQoL of ICU-survivors and healthcare related costs,~     and 4) care and support needs.~   "
24498|NCT03246321|"~     Summary intended for the lay public~        -  Background of study: approximately a quarter of the patients who are diagnosed with~          colorectal cancer and metastases have their metastases in the peritoneum, the so called~          peritoneal metastases. The vast majority of these patients cannot be cured by surgery,~          frequently due to too many peritoneal metastases. These incurable patients have a very~          short life expectancy. Nowadays, they are treated with chemotherapy through the veins.~          However, chemotherapy through the veins appears to be relatively ineffective against~          peritoneal metastases, probably because it does not reach the peritoneal metastases very~          well. Chemotherapy through the veins may also cause side effects that are sometimes~          severe. Recently, doctors developed PIPAC: a short laparoscopic operation during which~          chemotherapy is sprayed in the abdomen for 30 minutes, directly against the peritoneal~          metastases. As a result, PIPAC may be more effective against peritoneal metastases than~          chemotherapy through the veins. It may also have less side effects, because the~          chemotherapy mainly stays in the abdomen, not in the veins. PIPAC indeed shows promising~          results in the first European patients with peritoneal metastases of colorectal cancer~          who have been treated with this operation.~        -  Aim of study: to investigate whether PIPAC is a safe, feasible, tolerable, and~          potentially effective treatment for patients with peritoneal metastases of colorectal~          cancer.~        -  Participants: patients with peritoneal metastases of colorectal cancer, without~          metastases elsewhere (e.g. liver, lung), who cannot be cured by surgery due to too many~          peritoneal metastases.~        -  Treatment: instead of chemotherapy through the veins, participants receive PIPAC. PIPAC~          is a laparoscopic operation under general anesthesia. The entire operation takes about~          90 minutes. After the operation, patients stay in the hospital for at least one night.~          PIPAC is repeated every 6 weeks. The aim is to perform 3 PIPACs. If the peritoneal~          metastases respond well to PIPAC, participants may undergo more than 3 PIPACs.~          Participants may also undergo less than 3 PIPACs: for example if the peritoneal~          metastases do not respond PIPAC, if laparoscopy is unsafe for the patient, or if the~          surgeons cannot perform PIPAC due to adhesions in the abdomen. In case no further PIPACs~          can be performed, participants receive chemotherapy through the veins.~        -  Other appointments: four weeks after each PIPAC, participants visit the hospital for a~          CT-scan and an appointment at the oncological outpatient clinic to evaluate whether a~          next PIPAC can be performed. If not, participants receive chemotherapy through the~          veins. After the last PIPAC, patients visit the oncological outpatient clinic every 3~          months to evaluate how the cancer responds to the treatment.~        -  Potential risks for participants: PIPAC may cause side-effects. The most frequent~          potential side-effects are pain, nausea, fever, wound infection, diarrhea, obstipation,~          and minor damages to the kidney, liver, and bone marrow. These side-effects are mostly~          very mild. Moreover, the risk of side-effects of PIPAC is thought to be lower than the~          risk of side-effects of chemotherapy through the veins. Severe side-effects of PIPAC are~          extremely rare. The most important are a bowel perforation or a bleeding during PIPAC.~          So far, these severe side-effects have not been observed during PIPAC in patients with~          peritoneal metastases of colorectal cancer.~        -  Potential benefits for participants: PIPAC may potentially be similarly or even more~          effective against peritoneal metastases than chemotherapy through the veins, with a~          potential lower risk of side-effects. There may be a small chance (+/- 10%) that the~          peritoneal metastases become so small that they can be cured by surgery. However, these~          potential benefits are uncertain. The cancer may deteriorate at any moment during~          treatment with PIPAC.~        -  Hypothesis of study: the investigators expect that PIPAC is a safe, feasible, and~          tolerable treatment for patients with peritoneal metastases of colorectal cancer, with a~          potentially similar or higher efficacy against peritoneal metastases of colorectal~          cancer compared to chemotherapy through the veins.~   "
24499|NCT03246308|"~     Research project in which blood samples of patients undergoing UVB phototherapy for the~     treatment of different cutaneous diseases will be investigated for changes of folate levels~     and further vitamins over the course of treatment.~   "
24501|NCT03246282|"~     This study uses a prospective non-randomized, non-controlled design. One Hundred Fifty (150)~     subjects presenting with pain will be enrolled into a single treatment group The purpose of~     the study is to evaluate the feasibility of PLEDS for PIV catheter light delivery for pain~     reduction, through change between baseline average pain and final average VAS score. The~     absence of a control group is based on the following reason: The purpose of this~     investigation is to further the understanding of the feasibility of PLEDS for PIV catheter~     light delivery for pain management. Further, the results of this investigation will be used~     (internally only) to determine if subject-perceived reductions in pain warrant proceeding~     with more controlled, targeted and possibly randomized studies.~   "
24502|NCT03246269|"~     This observational cohort study in healthy volunteers establishes normative data for the~     German version of the Montreal Cognitive Assessment (MoCA) and investigates the possible~     impacts of demographics on the MoCA total score.~   "
24503|NCT03246256|"~     The aim of the study is to investigate the ability to recall information given during~     informed consent on intravenous thrombolysis in patients with acute ischaemic stroke.~   "
24504|NCT03246243|"~     The main goal of this study is to quantitatively assess the sucking and feeding activity of~     infants at high risk of neurological impairment (preterm infants and term infants with~     hypoxic ischemic injury) during oral sucking and feeding and correlate it with their~     underlying neurological impairment for the early diagnosis of brain injury.~   "
24505|NCT03246230|"~     Infection is the most common cause of death in early life, especially for newborns and can be~     reduced by immunization but insufficient knowledge of how vaccines protect the very young~     limits their optimal use. To gain insight into how vaccines induce protection of the most~     vulnerable, this National Institutes of Health (NIH)/National Institute of Allergy &~     Infectious Diseases (NIAID)-funded Human Immunology Project Consortium (HIPC) study, based at~     Boston Children's Hospital and conducted by the Expanded Program on Immunization Consortium~     (EPIC), employs two novel approaches studying newborn responses to hepatitis B vaccine (HBV):~     (a) systems biology that uses technologies which comprehensively measure global changes in~     molecules such as transcriptomics (RNA) and proteomics (proteins), as well as cell~     composition of the blood and (b) use of human newborn blood components, collected prior to~     immunization, to model vaccine responses in vitro (outside the body). Characterizing~     vaccine-induced molecular patterns (signatures) that correspond to vaccine-mediated~     protection will accelerate development and optimization of vaccines against early life~     infections of major global health importance.~   "
24506|NCT03246217|"~     Research has shown that music engages the brain bilaterally throughout cortical and~     subcortical regions, accessing extended sensorimotor, cognitive and affective networks. This~     research explores the hypothesis that use of these shared neural networks allows neurologic~     music therapy interventions targeting upper extremity motor control to promote plasticity and~     functional improvements in persons recovering from a cerebrovascular accident. The potential~     therapeutic benefits of these interventions on attentional processes and affective responding~     will also be examined.~   "
24507|NCT03246204|"~     The study is an observational, multicenter, prospective cohort study aimed at evaluating a~     5-year screening programme for chronic kidney disease(CKD) in a population of elderly~     patients, aged 65 years or more, in China.To analyze the etiology and composition spectrum,~     the incidence of complications and co-morbidities.To assess the correlation between daily~     living ability, mental and physical function, quality of life, nutritional status and~     prognosis.To develop biomarkers of renal aging.~   "
24508|NCT03246191|"~     The study is an observational, cross-sectional study aimed at screening and accessing risk~     factors and complications for Chinese chronic kidney disease (CKD) patients. To investigate~     the prevalence of hypertension, cardiovascular and cerebrovascular diseases, protein energy~     malnutrition（PEM）, cognitive impairment and other complications in the CKD patients. To~     develop biomarkers of CKD.~   "
24509|NCT03246178|"~     This is a prospective case-control study on SAA patients treated with HSCT, order to further~     discuss and assess the safety, feasibility and effectiveness of HFD-HSCT which performed with~     reduced-intensity fludarabine-based conditioning regimen.Our findings would indicate that SAA~     patients who lack MSD benefited most if HFD-HSCT was performed with reduced-intensity~     fludarabine-based conditioning regimen, and our improved outcomes with HFD-HSCT may lead to a~     salvaged therapy and an expanded direct role for SAA in the future.~   "
24510|NCT03246165|"~     The objective of this research was to determine the incidence, predisposing and triggering~     factors of delirium following cardiac surgery and its consequences within 30 days of surgery~     and during a 12-18-month follow-up in older adult patients.~   "
24511|NCT03246152|"~     Anti-vascular endothelial growth factor (VEGF) drugs are the mainstay of therapy for diabetic~     macular edema (DME), substantially improving visual acuity for many diabetics worldwide, and~     proving effective for treatment of both non-proliferative and proliferative diabetic~     retinopathy.~      Many studies such as Diabetic Retinopathy Clinical Research Network studies, RESTORE Study,~     and The BOLT Study have supported the use of different anti-VEGF agents in the treatment of~     DME with better visual outcomes using anti-VEGF injections alone or in combination with other~     treatments.~      Several ocular complications of intravitreal anti-VEGF injections have been reported~     including endophthalmitis, cataract and retinal detachment. The effect of anti-VEGF drugs on~     macular perfusion has been inconclusive, with mixed reports of increase, decrease or no~     effect on perfusion in response to anti-VEGF treatment. In many of these studies, however,~     patients with more ischaemic retinas were not included. Retinal ischemia is an important~     factor in the progression and prognosis of diabetic retinopathy.~      Fluorescein angiography (FA) was the method used to assess changes in macular perfusion after~     anti-VEGF injections in most of the studies. Despite its clinical usefulness, however, FA is~     known to have documented risks. Optical coherence tomography angiography (OCTA) is a new~     noninvasive method of acquiring high-resolution images of the retinal vasculature that can be~     utilized in the treatment of retinal disease without the need for dye injection. It allows~     the visualization of the superficial and deep retinal capillary layers separately and the~     construction of microvascular flow maps.~      Several studies have proved the reliability of OCTA in detecting and quantifying macular~     ischemia in diabetics.~      In this study, investigators aim to evaluate the effect of repeated intravitreal injections~     of different Anti-VEGF agents on the perfusion of different capillary layers in the macula of~     diabetic patients using OCTA.~   "
24512|NCT03246139|"~     The specific study aims will be:~        1. To investigate the short- and long-term treatment effects of action observation,~          imagery, and execution therapy (AOIE) compared with an action observation therapy (AO)~          group and a customary rehabilitation group as controls on different aspects of outcomes~          in patients with stroke.~        2. To examine the neural mechanisms and changes in cortical neural activity after the~          interventions in stroke patients.~        3. To examine the correlations between AOIE-induced brain activation changes and the~          clinical efficacy of AOIE.~        4. To identify who are the possible good responders to the therapy based on baseline motor~          function and motor imagery ability of the participants.~   "
24513|NCT03246126|"~     The purpose of this study is to evaluate the use of an investigational device called the~     ValiantTM Visceral Manifold Thoracoabdominal Stent Graft System for the repair of~     thoracoabdominal aortic aneurysms (TAAA), which is a balloon-like bulge in the aorta (major~     artery leading away from your heart) that originates in your chest and extends to your~     abdomen and also includes the branch arteries that supply blood to the liver, spleen,~     intestine, kidneys and other organs in your abdomen. The word investigational means the~     device is still being tested and is not approved by the Food and Drug Administration (FDA)~     for sale in the United States.~   "
24514|NCT03246113|"~     The goal of this single arm Phase I feasibility study is to investigate the tolerability of~     cannabis with concurrent chemoradiation in the treatment of glioblastoma multiforme (GBM). A~     strain of cannabis provided by The National Institute of Drug Abuse (NIDA) that has a high~     concentration of cannabidiol (CBD) and a low concentration of THC (relative to average street~     cannabis) will be tested in order to maximize clinical efficacy while minimizing intoxicating~     side effects in this medically-ill population.~   "
24515|NCT03246100|"~     This study is the second trial related to ClinicalTrials.gov ID: NCT02761551. There are~     slight changes to methods and a different cohort will be used, thus justifying a 2nd~     ClinicalTrials.gov submission. This trial is taking place in New York State (not NYC) and in~     Colorado. Each state has it's own ClinicalTrials.gov submission.~      Despite U.S. guidelines for influenza vaccination of all children starting at age 6 months,~     only about half of children are vaccinated annually leading to substantial influenza disease~     in children and spread of disease to adults. A major barrier is that families are not~     reminded about the need for their children to receive influenza vaccination. The~     investigators will evaluate the impact of patient reminder/recall (R/R) performed by state~     immunization information systems to improve influenza vaccination rates by using three~     clinical trials in two states. The investigators will assess effectiveness and~     cost-effectiveness of: 1) autodialer reminder/recall versus 2) postcard reminder/recall~     versus 3) usual care (no R/R) on improving influenza vaccination rates.~      The investigators will disseminate the state immunization information system based~     reminder/recall system to all states for use for both seasonal and pandemic influenza~     vaccinations with the goal of lowering influenza morbidity.~   "
24516|NCT03246087|"~     The purpose of this study is to determine if the addition of acupuncture to a standard of~     care prescribed exercise program is more effective at improving pain and function in adult~     patients with plantar fasciosis.~   "
24517|NCT03246074|"~     This research is being done to test the safety of the combination of the study drugs~     fostamatinib and paclitaxel. This study tests different doses of the drugs to see which doses~     are safest in people with ovaria cancer when given together.~   "
24518|NCT03246061|"~     Subjects will be randomized 1:1 Radio Frequency (RF) Ablation arm vs Control arm; this is an~     open-label trial. Subjects in the the RF Ablation arm will receive the Intracept System~     procedure to treat one or two motion segments. Subjects in the Control arm will continue on~     non-surgical management therapies to treat their chronic low back pain (CLBP) and will be~     offered optional crossover after 12 months of follow-up.~   "
24519|NCT03246048|"~     Objectives:~      The general objective of the present project is to gain a better understanding of disease~     outcome in cACLD patients treated with the new oral DAA. In particular, the project will~     focus on:~      - To evaluate the long term prognosis of patients with compensated advanced chronic liver~     disease (cACLD) who achieve sustained virological response (SVR) after the new oral~     direct-acting antiviral agents (DAA), and determine clinical and elastographic basal and~     follow-up parameters to identify low and high risk groups of developing liver-related~     decompensation.~      Methods:~      Prospective cohort study in patients with cACLD in whom basal and annual clinical features~     and liver stiffness measurements (LSM) will be performed, and survival free of liver-related~     events will be analyzed.~   "
24520|NCT03246035|"~     A randomized study designed to determine whether telephone based interventions can prevent~     return hospital visits for elderly and frail patients with acute symptoms of heart failure.~     Specifically, the intervention will improve patients ability to monitor and address self care~     of heart failure at home.~   "
24521|NCT03246022|"~     Obstructive sleep apnea syndrome (OSAS) is a common disorder characterized by recurrent~     obstruction of upper airway, leading intermittent oxygen desaturation and repetitive arousals~     during sleep, which can cause enhanced sympathetic activity, elevated levels of vasoactive~     substance concentration and vascular damage, and therefore, increase the risk of hypertension~     Continuous positive airway pressure (CPAP) prevents the airway collapse, avoids the~     occurrence of intermittent hypoxemia and arousal, is the preferred treatment for OSAS and has~     been widely used in clinical. In theory, CPAP maintains upper airway patency and preserves~     ventilation, thereby inhibits the chain reaction over activation of the sympathetic nervous~     system and blood pressure regulating mechanism, thus CPAP treatment have adequate scientific~     basis to cause a substantial reduction arterial blood pressure, but controlled studies showed~     either no effect or only a minor decrease in arterial blood pressure by 1.4 and 2.5 mmHg~     respectively.The current, which type of combination of hypertension OSA patients can obtain~     the best antihypertensive benefit from CPAP therapy is still under debate.~      Previous studies have shown that frequent blood pressure fluctuations associated with~     respiratory events can lead to increased blood pressure levels at night and even during the~     daytime in patients with severe OSA with hypertension. Continuous monitoring of nocturnal~     blood pressure fluctuations in OSA patients, not all OSA patients exhibited significant~     apnea-related nocturnal BP surges, some patients' nocturnal blood pressure fluctuations were~     independent of respiratory events, some spontaneous contractions, without respiratory events,~     micro-arousal, and leg movement ,which can lead to transient increases in blood pressure.~     Moreover, some patients did not show significant BP fluctuation but with high baseline BP~     level. If hypothesis that nocturnal BP fluctuation was irrelevant to the respiratory events~     or no obvious BP fluctuations existence during sleep, in these case, even if apnea or~     hypopnea events were eliminated by CPAP treatment, but a low size in antihypertensive effect.~     If BP fluctuations were the closely related to respiratory events and frequent nocturnal BP~     fluctuations resulted in daytime and nocturnal hypertension, in these case, CPAP treatment~     can significant lower both daytime and nocturnal BP level. A number of previous studies have~     shown that the efficacy of CPAP in decreasing BP level was unsatisfied. The investigator~     supposes whether or not during the process of recruitment, the characteristics of blood~     pressure fluctuation of OSA patients were not considered and result in a false judgment that~     the inefficacy of CPAP treatment on lowering BP levels.~   "
24522|NCT03246009|"~     The purpose of this study is to evaluate the tolerance and safety of the rHSA/GCSF in breast~     cancer patients with different doses and multiple injections.~      To observe the pharmacokinetic characteristics of recombinant human serum albumin~     /granulocyte colony-stimulating factor fusion protein after single and multiple~     administration~   "
24523|NCT03245996|"~     This study evaluates the acute effects of heart rate (HR) change on central hemodynamic~     parameters noninvasively.~   "
24561|NCT03245502|"~     Venoarterial CO2 difference(delta PCO2), lactate, central venous oxygen saturation(ScVO2)~     will be recorded in several steps in coronary artery bypass graft and valvular cardiac~     operations. The patients will be divided into two groups as Transfused, and Non-Transfused~     Groups observationally. The trend of delta CO2, lactate, ScVO2, postoperative creatinine~     values, postoperative complications and 28 days mortality will be compared.~   "
24524|NCT03245983|"~     The general aim of research is to identify and analyze the impact and role of spirituality~     (as a search for meaning and understanding of the meaning of existence) in the experience of~     cancer. For this purpose, the main objective of this study is to measure the existential~     component in the trajectory of the disease. It is a question of observing its potential~     contribution to the improvement of the quality of life of the patients and to define if this~     variable can be translated into a strategy of adjustment for the patients. This research has~     a double interest: (a) clinical interest in better managing patients' needs; (B) an interest~     in research in the field of health by combining a measure of spirituality with other~     psycho-social variables.~      The project is a prospective non-randomized mono-centric study by questionnaire and research~     interview. It is a study that seeks to identify the role of spirituality in the experience of~     illness (i.e. representations, adjustments, emotional distress) and as a determinant of the~     quality of life of subjects with cancer pathology.~      The interviews will be conducted by a psychologist to qualitatively collect the elements of~     the lived experience of the disease in connection with the spiritual elements of the quest~     for meaning type.~      The population covered by the project is in and out patients coming to the Department of~     Medical Oncology and Palliative Care at the CHU de la Timone.~      The realization of this project will allow investigators to explore the specificity of the~     existential / spiritual dimensions of patients confronted with cancer, to assess the~     patients' needs for this type of approach within the hospital, to link the existential~     component / Spiritual with psycho-social variables~   "
24525|NCT03245970|"~     To determine if the use of impedance cardiography can identify appropriate medications for~     use in treating chronic hypertensive patients to decrease the risk of preeclampsia.~   "
24526|NCT03245957|"~     The study investigates the effect of plasma myeloperoxidase (MPO) concentrations on HDL~     dysfunction during the acute stage of ischemic and haemorrhagic strokes.~   "
24527|NCT03245944|"~     Arteriovenous fistulas (AVFs) are the preferred type of vascular access for dialysis, but~     many of them fail to mature. The optimal timing of intervention to salvage immature AVFs is~     unknown.The study proposes a randomized clinical trial comparing the clinical and economic~     impact of early vs late angioplasty in non-maturing AVFs.~      The study proposes a RCT to test the hypothesis that, as compared to early angioplasty of~     non-maturing AVFs, late angioplasty results in a lower proportion of AVFs being used at 6~     months, but a greater long-term AVF patency , lower requirement of subsequent interventions~     to maintain AVF patency for dialysis, and lower overall cost of access maintenance.~   "
24528|NCT03245931|"~     The goal of this study is to assess the health literacy level of patients enrolled in the~     HOPE program, identify any gaps in their knowledge of hepatitis C, analyze the variables that~     may influence patients' knowledge, and educate patients on Hepatitis C.~   "
24529|NCT03245918|"~     Antiemetic therapies have improved in recent years, but chemotherapy-induced nausea and~     vomiting (CINV) are still common and are among the most distressing side effects of~     chemotherapy. Aprepitant is commercially available in Canada as capsules. An oral liquid~     aprepitant formulation would be ideal for oral administration to patients unable to swallow~     capsules.~   "
24530|NCT03245905|"~     This is a prospective phase II clinical trial to observe the efficacy and safety of Chidamide~     as a single-agent treatment in patients with relapsed or refractory B-cell Non-Hodgkin's~     Lymphoma (NHL).~   "
24531|NCT03245892|"~     The purpose of this study is to find out what effects, good or bad, the addition of nivolumab~     to typical chemotherapy has on the patient and their cancer.~   "
24532|NCT03245879|"~     Core elements of effective antibiotic stewardship programs (ASPs) have been identified and~     evidence-based guidelines have been developed for implementation. The majority of the~     evidence used for these guidelines are from published studies on the effectiveness of ASPs in~     large academic or large community hospitals. A significant portion of healthcare in the~     United States, however, takes place in small hospitals. In 2015, 73% of US hospitals had <~     200 beds (4,057 hospitals) and accounted for 29% of all US inpatient bed days. Limited~     studies on the effectiveness of antibiotic stewardship implementation have been performed in~     hospitals with < 200 beds. Antibiotic use rates and selection patterns in these small~     hospitals are similar to that of large hospitals and the majority of small hospitals lack~     formal ASP that meet the CDC's core elements. The objective of this real-world implementation~     study was to assess the effectiveness of three ASP strategies of escalating intensity~     designed specifically for small hospitals within a vertically integrated healthcare delivery~     system.~   "
24533|NCT03245866|"~     This registry was created to assess management parameters of patients treated for aneurysmal~     subarachnoid hemorrhage in Switzerland. All Swiss hospitals with a neurosurgery department,~     an intensive care unit and an interventional neuroradiology team that treat neurovascular~     emergencies participate in the registry. Clinical parameters are entered into a common~     database. This database will provide (1) a nationwide assessment of the current standard of~     care and (2) the outcomes for patients in Switzerland including neuropsychological~     assessments.~   "
24534|NCT03245853|"~     Epithelium-On Corneal Crosslinking for Keratoconus.~   "
24535|NCT03245840|"~     This is a continuation study of Budesonide Oral Suspension (BOS) in adults and adolescents~     with Eosinophilic Esophagitis (EoE) who have completed participation in the SHP621-302~     extension study. The purpose of this study is to see if BOS is safe and well tolerated over~     the long-term in adolescents and adults with EoE.~   "
24536|NCT03245827|"~     Obesity can lead to low testosterone concentrations in young men. This study will study the~     effects of low testosterone in those men and the result of treating them with clomiphene.~   "
24537|NCT03245814|"~     The purpose of this study is to quantify the therapeutic efficacy and role of trained service~     dogs on socio-emotional functioning among military veterans with posttraumatic stress~     disorder (PTSD).~   "
24562|NCT03245489|"~     The purpose of this study is to see if anti-platelet therapy combined with anti-PD-1~     immunotherapy can cause a more favorable immunologic response thatn with immunotherapy alone~     in patients with recurrent or metastatic squamous cell carcinoma of the head and neck.~   "
27301|NCT03209648|"~     Debio 1450 is metabolised mainly by CYP3A4, therefore inhibitors of CYP3A4 have the potential~     to raise Debio 1450 plasma concentrations. Hence, it is important to determine the effect of~     CYP3A4 inhibition by itraconazole on the Pharmacokinetics of Debio 1450.~   "
24538|NCT03245801|"~     Juvenile Idiopathic Arthritis (JIA) is a disorder of unknown cause characterized by chronic~     inflammation of the joints and other organs. It affects about 1 in a 1000 Canadian children~     and if untreated it can produce lifelong disability. The Canadian Alliance of Pediatric~     Rheumatology Investigators (CAPRI) includes most pediatric rheumatologists in Canada. They~     have successfully collaborated for the past 10 years producing groundbreaking research on the~     modern course and outcomes of JIA. CAPRI proposes an ongoing universal registry of Canadian~     children with JIA that will collect longitudinal data on disease course, outcomes and adverse~     events to inform healthcare decisions and to gain new insights into the disease and its~     treatment.~   "
24539|NCT03245788|"~     The Stanford Cancer Center is undertaking a Transformation Initiative in order to improve the~     quality of care, make it more patient-centered and coordinated across the continuum of care.~     The newest innovation is to introduce lay navigators to specified high-need patients. The~     larger goal of the project is to assess whether lay navigators can address non-clinical~     patient needs in a timely fashion and appropriately connect them with their clinical team~     when warranted. It is expected that proactive interaction with patients will decrease patient~     anxiety/stress related to their cancer and facilitate higher patient engagement and improved~     management of physical, social,and emotional health. For the pilot project, the smaller goal~     is to understand: how lay navigator time is used; the types and frequency of issues brought~     up by patients; resources that patients are given or referred to; type and frequency of mode~     of contact with patients; and patients' acceptance of navigators based on refusal. An~     electronic intake form will be used to collect this information so that data can be analyzed~     regularly and informed change can be made to the navigator program as needed~   "
24540|NCT03245775|"~     The primary aim is to determine the relative effectiveness in child BMI z-scores at 3, 6, and~     12-months post baseline of iChoose+ versus Family Connections. Secondary aims are to~     determine (1) ongoing reach, fidelity, and implementation costs, (2) community capacity for~     implementation and sustainability, (3) relative impact on family eating/physical activity and~     parental weight, and (4) relative adherence and potential dose response relationships.~   "
24541|NCT03245762|"~     The purpose of this study is to compare the change in suck and swallow competency from~     baseline to morning of day 6 with intranasal oxytocin spray vs placebo in infants/children~     with Prader-Willi Syndrome who are in nutritional phase 1a. Videofluoroscopic swallow studies~     will be performed on treatment day 1 and on the day following treatment morning of day 6.~   "
24542|NCT03245749|"~     The purpose of this study is to investigate the effect of habitual oily fish intake, sex,~     age, BMI, and APOE genotype on plasma long chain n-3 fatty acid composition.~   "
24543|NCT03245736|"~     The purpose of the trial is to evaluate efficacy and safety of continued treatment with~     tisotumab vedotin.~   "
24544|NCT03245723|"~     The purpose of this research is to determine the effect of premature birth on later heart~     function and metabolism.~   "
24545|NCT03245710|"~     This study investigates the efficacy and mechanism of traditional Chinese medicine formula~     power product in the treatment of osteopenia in patients with pain. Half of participants will~     receive Chinese medicine formula power product, while the other half will receive a placebo.~   "
24546|NCT03245697|"~     Human milk is not a uniform body fluid, but quite the opposite, its composition changes~     continuously adapting to the requirements of the newborn. It can be considered as the gold~     standard for infants' nutrition and exclusive breastfeeding is recommended by the WHO during~     the first months of life. Additionally, its composition should be used as reference or~     guidance for defining optimal nutrient intakes for infants that cannot be fully breastfed. In~     that connection, the nutritional status and dietary habits/patterns of the mother, along with~     certain genetic traits, exert also influence over breast milk. Considering all these facts,~     and their great impact on (present and future) infant health, detailed information of breast~     milk composition is required for specific populations, covering as many factors, elements and~     nutrients as possible.~      In the present observational study, research is focused on breast milk in northwestern Spain,~     more precisely Galicia. In this context, the obtained data will serve to define the~     nutritional characteristics of breast milk from Galician women (interindividual variation),~     while at the same time evaluating the existence of specific features related to their~     particular diet (dietary factors), the Southern European Atlantic Diet (SEAD). All the~     variables measured in this research project will be related with breast milk composition.~     Expected primary outcomes can be divided as follows: fatty acid profiles, mineral~     composition, essential amino acid profiles, microbiota and steroid hormones. The key~     influencing factors taken into account are: lactation characteristics and maternal diet.~      Recruitment of participants is based on all the following criteria, with no exceptions:~     female, living in Galicia, lactating, > 18 years old, volunteer participation, written~     informed consent and agreement to complete questionnaires about lactation, diet and other~     socio-demographic factors. Samples are collected by participants, and stored at the~     University of Santiago de Compostela under a coded system so that it is impossible to~     identify the donor from whom the sample comes, with the exception of the investigators. The~     project is adhered to the principles of the Helsinki Declaration. Participants are allowed to~     withdraw their consent at any moment of the study.~   "
24547|NCT03245684|"~     The present pilot randomized controlled clinical trial will test the hypothesis that in~     patients with ARDS, fixing ventilator settings to the conventional protective ventilatory~     strategy (VT 6 ml/kg ideal body weight and Pplat ≤ 30 cmH2O, PEEP according the PEEP/FiO2~     table), control modes of mechanical ventilation will be associated to a concentration of~     pulmonary and systemic inflammatory mediators lower than the concentration of inflammatory~     mediators observed during assisted modes of mechanical ventilation.~   "
24548|NCT03245671|"~     Chronic lumbosacral radiculopathy secondary to lumbar spinal stenosis affects a large number~     of individuals, and there is a general lack of consensus in the medical community in terms of~     effective treatments for this problem. By assessing the relative efficacy of transforaminal~     epidural injections of particulate and nonparticulate steroids, this study attempts to~     further define the appropriate conservative management of painful unilateral radiculopathies~     due to unilateral lumbar foraminal stenosis. Patients will be randomized to receive a~     transforaminal epidural injection of either a particulate (Kenalog) or nonparticulate~     (Decadron) steroid. Outcomes will be assessed at 2 weeks, 6 weeks, 3 months, and 6 months~     following the injection.~   "
24576|NCT03245307|"~     Apatinib, an oral inhibitor of vascular endothelial growth factor receptor 2（VEGFR-2）,~     inhibits multiple cytochrome P450 (CYP450) enzymes in vitro. This study in patients with~     advanced cancer evaluated the effect of Apatinib on CYP450 function by comparing the~     pharmacokinetics of CYP-specific probe drugs in the presence and absence of Apatinib. The~     probes used included Nifedipine (CYP3A specific), warfarin (CYP2C9 specific).~   "
24577|NCT03245294|"~     The purpose of this study is to evaluate the decrease pattern of lumbar epidural pressure~     from ligamentum flavum to epidural space and analyzing factors contributing this pressure~     change pattern.~   "
24549|NCT03245658|"~     The prevalence of malnutrition is overwhelming in pancreatic cancer patients, >80% experience~     a weight loss >10% of their habitual weight, which may develop into cancer cachexia. Cachexia~     may cause decreased quality of life, increased mortality and morbidity e.g. poorer response~     to antitumor treatment, longer length of stay, higher complications rate and shorter life~     expectancy. There is currently no effective treatment of cancer cachexia, but clinical~     research in medical cannabis show promising results. The cannabinoids THC and CBD show the~     highest pharmacological effect, but cannabis consists of >70 cannabinoids. THC and CBD exert~     their effect on the endocannabinoid system which modulate physiological systems such as pain,~     inflammation, appetite and energy balance. Thus, this potential orexigenic effect from THC~     and CBD may improve the nutritional state in patients with pancreatic cancer. Taking the~     above scientific rationale and the lack of evidence into account, the relevance of this~     clinical trial appears high.~      This clinical trial is an eight-week crossover design examining the effects of the~     cannabinoids THC and CBD on energy- and protein intake and lean body mass as a measure of~     appetite, nausea and quality of life. A characterization of the metabolism is analysed~     through a metabolomics analysis.~   "
24550|NCT03245645|"~     The purpose of this study is to determine the amount and timing of when certain Fermentable~     Oligo-Di-Monosaccharides and Polyols (FODMAPs), specifically fructose, can be safely~     reintroduced into the diet of Irritable Bowel Syndrome (IBS) patients that have successfully~     completed a low-FODMAP elimination diet. The FODMAP diet is an effective treatment for IBS;~     however it is unclear how patients can successfully reintroduce and liberalize fructose into~     their diet. The low FODMAP diet is thought to reduce IBS symptoms by decreasing water content~     and gas production in the bowel and also possibly by altering gut bacteria. Although use of~     the FODMAP elimination diet can initially successfully treat IBS symptoms for up to 50-75% of~     patients, the reintroduction diet is difficult for patients to complete and maintain for long~     periods of time because current methods for reintroduction of FODMAPs are imprecise leading~     to frequent recurrent symptoms. As a result, patients often continue the low FODMAP~     elimination diet for additional months because they have difficulties knowing how to add back~     Protocol ID:IRB#16-000934 UCLA IRB Approved Approval Date: 2/22/2017 Through: 9/20/2017~     Committee: Medical IRB 1 FODMAPs into their diet. There are no studies to date to help guide~     patients with FODMAP reintroduction. For example, in the case of reintroducing fructose,~     patients currently are currently instructed to add back honey into their diet over a 3-day~     period using honey in 1- 3tsp doses (equivalent roughly to 2.86-8.6 grams of fructose).~     However, honey is a sweetener made of both fructose and glucose and it is unclear whether~     recurrent IBS symptoms are related to the concentration of fructose or the concentration of~     fructose that is in relative excess to glucose. These types of confounding problems make it~     difficult to generalize dietary reintroduction. The three study groups (i.e. fructose,~     glucose, fructose/glucose) in this study are designed to determine if and how fructose leads~     to recurrent IBS symptoms during the reintroduction diet. The fructose group will help to~     determine whether an absolute amount of fructose will lead to IBS symptoms. Based on the~     principals of the diet, we hypothesize IBS patients have lower thresholds for fructose~     tolerance.~      The glucose group will serve as a control since glucose is not a FODMAP and as a result is~     not expected to lead to recurrent symptoms. The glucose/fructose mixture group is a cross~     comparison group that will determine whether the relative excess fructose concentration is an~     important cause of IBS symptoms. Fructose absorption in the gut is dependent on glucose~     intake as fructose is transported with glucose from inside the gut into the body. Current~     studies suggest that fructose intolerance in healthy controls is highly dependent on the~     ratio of excess fructose to glucose.~      The fructose/glucose treatment group is designed to investigate this potential relationship.~   "
24551|NCT03245632|"~     Klebsiella pneumoniae is one of the most common pathogens causing nosocomial infection.~     Recently, the emergency of Carbapenem-Resistant Klebsiella pneumoniae (CRKP) had cause the~     clinical therapy be very difficult. However, there is not much empirical data as to the~     prevalence, risk factors, characteristics, and the rationality of the current therapy for the~     CRKP infection. Thus, the study was aimed to investigate the epidemiology and risk factors,~     characteristics, and the rationality of the current therapy for the CRKP infection.~   "
24552|NCT03245619|"~     GSK3335065 is being developed as a treatment for acute pancreatitis with the intent of~     reducing 3-hydroxykynurenine (3HK) levels to the normal range (or lower) and maintaining them~     at this level throughout the treatment period. This study will utilize an adaptive design and~     is divided into 3 parts. Part A will consist of two cohorts (1-2) and is Single Ascending~     Dose (SAD) of GSK3335065 by IV bolus in males. Part B will be initiated after completion of~     dosing in Part A. It will involve ascending IV bolus doses of GSK3335065 followed by IV~     constant infusion for 7 days in males and will consist of four cohorts (3-6). Part C consists~     of a single dose of GSK3335065 by IV bolus (cohort 7), and a single dose followed by~     continuous infusion over 7 days (cohort 8) in females of non-child bearing potential~     (WONCBP). Total 64 subjects will be evaluated in the study of which Part A will include 16~     healthy male subjects, Part B will include 32 healthy male subjects and Part C will include~     16 WONCBP. Part A will last up to 19 weeks and Part B will last up to 13 weeks. In Part C~     cohort 7 will last up to 7 weeks and cohort 8 will last for 13 weeks.~   "
24553|NCT03245606|"~     The main objective is to compare the accuracy of transient elastography taking into account~     liver steatosis determined by MRI, to liver biopsy for the diagnosis of liver fibrosis ≥F2 in~     patient with NAFLD.~   "
24554|NCT03245593|"~     The investigators hypothesize that implementation of a shared decision making care plan for~     prophylactic treatment will help therapeutic adherence of bipolar patients. They also~     anticipate that patients treated according to a shared decision making plan will have an~     elevated satisfaction of their care, quality of life and functionment, as well as a lower~     number of relapses~   "
24555|NCT03245580|"~     The primary purpose of this prospective, randomized, multicenter study is to evaluate and~     compare the amount and quality of tissue samples yielded in a liver biopsy comparing 2~     different techniques of EUS guided CORE liver biopsy for benign disease. The two techniques:~     modified Wet suction and Slow pull technique of collecting tissue from a liver biopsy via~     Endoscopic Ultrasound (EUS).~   "
24556|NCT03245567|"~     This study is designed to:~        1. Implement a Web platform intended to host perceptual learning modules (PLMs)~        2. Implement and assess a PLM designed to improve the capacity of first-year residents to~          visually estimate the left ventricular ejection fraction (LVEF) with transesophageal~          echocardiography (TEE) images.~      The hypothesis of the study is that the PLM will improve the visual assessment of LVEF by TEE~     in junior residents.~   "
24557|NCT03245554|"~     To research the effect of propranolol on the proliferation and apoptosis of gastrointestinal~     cancer.~   "
24558|NCT03245541|"~     This study is being done to determine the safety and tolerability of durvalumab in~     combination with stereotactive ablative radiotherapy (SABR), a standard radiation treatment,~     for patients with pancreatic cancer.~   "
24559|NCT03245528|"~     The primary objective of the study is to provide access to LJPC-501 for distributive shock~     patients who remain hypotensive despite receiving fluid and vasopressor therapy.~   "
24560|NCT03245515|"~     The purpose of this study is to investigate the effects BMS-986195 in healthy male subjects.~   "
27609|NCT03205592|"~     This prospective observational study aims to assess whether ultrasound assessment of gastric~     content may be useful for the monitoring of the gastric residual content in critically ill~     patients~   "
24563|NCT03245476|"~     This study aims, by means of a randomized control trial, to investigate which treatment~     method (corticoid injection + physiotherapy with a focus on manual therapy and home-exercises~     versus corticosteroid injection + physiotherapy with focus on education and supported home~     exercises) gives better results on clinically relevant outcomes (range of glenohumeral~     motion, psychological factors, pain, shoulder function, quality of life) and on parameters~     derived from arthroscopic glenohumeral investigation by means of MRI.~      Furthermore, associations between (1) the results on the MRI investigation, (2) the range of~     glenohumeral motion, (3) shoulder function and pain, and (4) psychological factors will be~     assessed at different time-points (before and at 6-12-18 and 52 weeks after the first~     injection).~   "
24564|NCT03245463|"~     Symptomatic knee osteoarthritis greatly impacts the quality of life, mobility, independence,~     and even safety of the individuals who suffer from it. One of the most powerful tools for~     these patients can be education on self-care and self-management strategies that can be~     taught to a patient by a physician, physical or occupational therapist, or a nurse. These~     self-management strategies can help patients treat daily stiffness through exercise or manage~     flares of osteoarthritis. There is a lack of consensus on the best teaching methods to~     accomplish the goal of educating our patients. Feedback from both patients and providers~     regarding teaching methods is needed. This study will evaluate teaching methods on~     self-management strategies for patients who are undergoing hyaluronic acid injections for~     knee osteoarthritis.~   "
24565|NCT03245450|"~     The Phase 1 part of the study is conducted to determine the maximum tolerated dose (MTD) and~     Recommended Phase 2 Dose (RP2D) of eribulin mesilate in combination with irinotecan~     hydrochloride in pediatric participants with relapsed/refractory extra-cranial solid tumors.~      The Phase 2 part of the study is conducted to assess the objective response rate (ORR) of~     eribulin mesilate in combination with irinotecan hydrochloride in pediatric participants with~     relapsed/refractory rhabdomyosarcoma (RMS) and non-rhabdomyosarcoma soft tissue sarcoma~     (NRSTS).~   "
24566|NCT03245437|"~     This study will measure whether the engagement of intranasal oxytocin with a brain target is~     related to effects on learning during a social cognition training program.~   "
24567|NCT03245424|"~     To provide access to ivosidenib monotherapy to patients with relapsed or refractory acute~     myeloid leukemia (AML) with an isocitrate dehydrogenase 1 (IDH1) mutation.~   "
24568|NCT03245411|"~     Einstein Medical Center in Philadelphia serves a diverse group of the patient population. The~     majority of patients have a diverse cultural background, low literacy, and poor~     social-economic status. Medication adherence for chronic medical problems is in a range of~     40-70%. Medication adherence among patients on oral anti-cancer therapy is not studied in~     detail. The main objective is to study medication adherence to oral anticancer agents in~     patients with low literacy and poor socio-economic status.~   "
24569|NCT03245398|"~     This study is a double-blind randomized clinical trial which aims at providing evidence on~     the efficacy and safety of two regimens of mebendazole in school-aged children. Thus, our~     primary objective is to assess the efficacy and safety of: i) 100 mg solid tablets twice a~     day for 3 days, and ii) one dose of 500 mg solid tablets of mebendazole in participants aged~     6-12, inclusive, infected with hookworm.~      The primary endpoint of the trial is the cure rate (CR) of the 3-day regimen of mebendazole~     against hookworm and a single dose mebendazole treatment.~      The secondary objectives are to determine if the multi-dose regimen is superior to the single~     dose regimen, evaluate the efficacy against concomitant soil-transmitted helminth infections,~     and assess the safety of both mebendazole regimens.~      After obtaining informed consent from children's caregiver, the medical history of the~     participating individuals will be assessed with a standardized questionnaire, in addition to~     a clinical examination carried out by the study physician on the treatment day. Enrollment~     will be based on two stool samples which will be collected, if possible, on two consecutive~     days or otherwise within a maximum of 5 days apart. All stool samples will be examined with~     duplicated Kato-Katz thick smears by experienced laboratory technicians.~      Randomization of participants into the two treatment arms will be stratified according to~     intensity of infection. Participants will be interviewed before treatment for clinical~     symptoms and 3 hours after every morning treatment and 24 hours after every morning treatment~     about the occurrence of adverse events. The efficacy of the treatment will be determined~     14-21 days post-treatment by collecting another two stool samples.~      The primary analysis will include all participants with primary end point data (available~     case analysis). Supplementary, two sensitivity analyses will be conducted imputing all~     missing endpoint data as treatment failures or all as treatment success. CRs will be~     calculated as the percentage of egg-positive participants at baseline who become egg-negative~     after treatment. CRs will be compared by using unadjusted logistic regression. To assess~     model robustness with respect to covariates, adjusted logistic regressions (adjustment for~     age, sex, school, weight and strata) will be performed.~      Geometric and arithmetic mean egg counts will be calculated for the different treatment arms~     before and after treatment to assess the corresponding ERRs. Bootstrap resampling method with~     5,000 replicates will be used to calculate 95% confidence intervals (CIs) for ERRs and the~     difference of the ERRs.~   "
24570|NCT03245385|"~     This is an open-label, safety study designed to assess the multiple-dose pharmacokinetics and~     potential for adrenal suppression following topical treatment with halobetasol propionate~     0.05% spray applied twice-daily in adult patients with moderate to severe atopic dermatitis.~     At least 40 eligible patients with atopic dermatitis that satisfy all eligibility criteria~     will be enrolled into the study~   "
24571|NCT03245372|"~     The primary aim of this study is to quantify and compare the hemodynamic control of cardiac~     index in patients who receive either goal-directed therapy or standard hemodynamic management~     in lung resection surgery~   "
24572|NCT03245359|"~     The purpose of this study is to determine if there is any significant difference between~     using a short-term ON-Q nerve block (which is applied prior to surgery and maintained in~     place until the medication in the initial balls have been fully used, usually 2-4 days) in~     comparison to a long-term ON-Q nerve block (which is applied prior to surgery and maintained~     in place up to seven days after surgery). This study will analyze patient reported levels of~     pain, range of motion, and narcotic use, as well as investigate whether blood loss, blood~     thinners, and hemoglobin/hematocrit blood levels influence patient pain levels.~      This study will compare patient-reported pain, range of motion and narcotic use in total knee~     arthroplasty patients who receive the short-term and long-term combination nerve block~     (saphenous and posterior of the adductor canal and wide-field posterior knee.~   "
24573|NCT03245346|"~     The purpose of this randomized controlled trial is to investigate the effects of epidural~     anesthesia and analgesia on the overall survival，disease-free survival and recovery in~     patients undergoing pancreatic cancer surgery. This study will also evaluate the effects of~     this technique on neuroendocrine, stress and inflammatory response in these patients.~   "
24574|NCT03245333|"~     According to the results of the phase II study, choose the best dose of JINTOPIN AQ for short~     SGA children, further to evaluate the efficacy and safety of the treatment of short SGA~     children.~   "
24575|NCT03245320|"~     A post market, non-randomized, multi-center, open-label,clinical study using survivorship to~     study the safety and efficacy of the Integra® TITAN™ Total Shoulder System 1.0 (TAS) when~     used for total shoulder arthroplasty.~   "
24579|NCT03245268|"~     The International Balloon Pulmonary Angioplasty (BPA) Registry is a prospective,~     multi-center, long-term observational project. Scheduled to start data collection in Q4 2017,~     the registry will run for approximately four years with a follow-up time for each patient of~     at least two years. Its primary objective is to investigate the efficacy and safety of BPA~     intervention in patients with chronic thromboembolic pulmonary hypertension (CTEPH) not~     amenable to pulmonary endarterectomy (PEA).~   "
24580|NCT03245255|"~     This study will use contrast echocardiography to assess the accuracy of a new non-invasive~     imaging method for subharmonic aided pressure estimation (SHAPE) compared to simultaneously~     acquired intra-cardiac pressures measured invasively during cardiac catheterization. This~     study is designed to verify that contrast echocardiography using the SHAPE method, already~     proven in a canine model and tested in a human pilot study can be used as a surrogate for~     cardiac catheterization with sufficient accuracy to allow clinical applicability in humans.~   "
24581|NCT03245242|"~     The purpose of this research study is to evaluate an Enhanced Recovery After Surgery (ERAS)~     protocol in children and young adults undergoing urologic reconstructive surgery. The~     investigators plan to collect data on speed of recovery (how quickly pain improves, length of~     time in the hospital, and the need for additional pain control) on patients who receive care~     under the ERAS protocol and compare it to historical controls.~   "
24582|NCT03245229|"~     The primary purpose of this study is to investigate the effect of ACT-132577 at steady state~     on the pharmacokinetics of single-dose rosuvastatin in healthy male subjects~   "
24583|NCT03245216|"~     The study is designed to assess the effects of aerobic exercise on motor learning in~     Parkinson patients. Specifically, the investigators examine whether a single bout of moderate~     intensity aerobic exercise, performed immediately before task practice, facilitates the~     acquisition and retention of a motor skill. In a cross-over design, participants will be~     randomly allocated to either the intervention group (aerobic exercise before motor learning)~     or control group (rest before motor learning).~   "
24584|NCT03245203|"~     Background: Neoadjuvant chemoradiotherapy (CRT) and total mesorectum excision (TME) has~     become the standard therapy for the treatment of locally advanced rectal cancer (LARC) to~     reduce the local recurrence rate, however, no improvement of distant metastasis rate was~     observed, and the incidence of postoperative local recurrence and distant metastasis can~     reach more than 25%. It is still a challenge for us to improve the RO resection rate of~     locally advanced rectal cancer and reduce the incidence of local recurrence and distant~     metastasis.~   "
24585|NCT03245190|"~     Chiauranib, which simultaneously targets against VEGFR/Aurora B/CSF-1R, several key kinases~     involved in tumor angiogenesis, tumor cell mitosis, and chronic inflammatory~     microenvironment.~   "
24586|NCT03245177|"~     Lung cancer is the leading cause of cancer mortality worldwide and in the U.K alone; there~     are 38,000 new cases of non-small cell lung cancer (NSCLC) a year. The new treatment being~     tested in this study is called pembrolizumab, this is a type of immunotherapy, which works by~     stimulating the body's own immune system to fight cancer cells.~      Pembrolizumab blocks a protein on the T-cell surface (one of the cells of the immune system),~     which then triggers the cell to find and kill cancer cells. This will be given with~     radiotherapy to see if this combination is safe and effective at treating patients with~     non-small cell lung cancer.~      Pembrolizumab has proved to be a safe and effective treatment for other cancers such as~     melanoma and lung cancer. Radiotherapy is often given as standard treatment to treat lung~     cancer, and is proven to be a safe and tolerable treatment. However, the safety of the~     combination of Pembrolizumab and thoracic radiotherapy delivered concurrently has not been~     tested yet prospectively~   "
24587|NCT03245164|"~     This study aimed to compare the effects of group exercises under physiotherapist control and~     basketball program on body composition and motor skills of obese children. 45 obese children~     aged 10 years were randomly included to the physiotherapy (n=15), basketball (n:15), and~     control group (n:15). The children were assessed before and after 12-week study duration.~     Body Mass Index (BMI), the percentage of body fat, and circumference values of the children~     were recorded. Bruininks-Oseretsky Test of Motor Proficiency-Brief Form (BOTMP-BF) was used~     to determine motor skills of children.~   "
24588|NCT03245151|"~     Phase 1 of this study, utilizing a rolling 6 design, will be conducted to determine a maximum~     tolerated dose (MTD) and recommended Phase 2 dose (RP2D), and to describe the toxicities of~     lenvatinib administered in combination with everolimus once daily to pediatric participants~     with recurrent/refractory solid tumors. Phase 2, utilizing Simon's optimal 2-stage design,~     will be conducted to estimate the antitumor activity of lenvatinib in combination with~     everolimus in pediatric participants with selected recurrent/refractory solid tumors~     including Ewing sarcoma/peripheral primitive neuroectodermal tumor (pPNET), rhabdomyosarcoma,~     and high grade glioma (HGG) using objective response rate (ORR) at Week 16 as the outcome~     measure.~   "
24589|NCT03245138|"~     An endoscopic third ventriculostomy is considered to be successful in idiopathic normal~     pressure hydrocephalus (iNPH) in some literature reports, but there is a lack of high quality~     data. The aim of the present study is to compare the treatment options of iNPH (Endoscopic~     third ventriculostomy versus ventriculo-peritoneal shunt) in a randomized, controlled,~     multicenter study.~   "
24590|NCT03245125|"~     BACKGROUND Global burdens of heart failure (HF) are increasing in modern societies.~     High-intensity interval training (HIIT) increases peak oxygen consumption (VO2peak) in HF~     patients, which was hypothesized to improve the survival of HF patients.~      OBJECTIVES The cohort study aimed to highlight the effect of HIIT on long-term survivals of~     HF patients.~      METHODS 329 HF patients, enrolled between 2009 and 2016, received multidisciplinary disease~     management program (MDP). They had cardiopulmonary exercise test for peak exercise capacity~     (VO2peak), echocardiographic examination for left ventricular ejection fraction (LVEF), LV~     end-diastolic diameter (LVEDD), and LV end-systolic diameter (LVESD), b-type natriuretic~     peptide (BNP), and quality of life questionnaire. HF patients with LVEF≤ 40% (HFrEF) and HF~     patients with LVEF> 40% (HFpEF) underwent≥ 36 times of HIIT. HFrEF and HFpEF patients were~     classified as the MDP group. Generalized estimating equation (GEE) was used to estimate the~     interaction between time and VO2peak, LVEF, LVEDD, LVESD, and BNP during the follow-up.~     Survival analysis was conducted to assess effects of HIIT on the long-term survival of HF~     during at end of the study.~   "
24591|NCT03245112|"~     Since the first marketing authorization in the world in November 2010 granted by US FDA,~     Halaven has been approved for clinical use in more than 40 countries worldwide, including~     many Asian countries, e.g. Hong Kong, India, Japan, Malaysia, Myanmar, Philippines, South~     Korea, Singapore, Taiwan and Thailand. According to two large global phase III study reports~     of Halaven, very few Asian patients participated in these studies. In a phase II study of~     Halaven with metastatic breast cancer, the clinical efficacy and toxicity were reported only~     in 80 Japanese patients. Halaven has been granted its marketing authorization in Singapore~     since February 2011. However, most of other Asian countries including India have had the~     approval and launched from middle year of 2013 or in early 2014. Limited information of~     Halaven using in Asian patients are available except several case experience exchange~     presented by individual medical centers or as personal experience in the past. Some clinical~     concerns related to Halaven use are raised by clinicians during their clinical practice, such~     as how Halaven works on Asian patients, which type of patient obtains better clinical benefit~     from Halaven, and what are the main treatment related toxicities in Asian which may differ~     from Westerners due to potential ethnic diversity. Further understanding of Halaven related~     clinical benefit and toxicity in Asian patients through collecting clinical experience among~     Asian countries becomes necessary and may provide better information to anticipate these~     concerns.~      The proposed Halaven Patient Registry (called the Registry) will be a patient~     population-based registry to collect therapeutic related information from patients with~     metastatic breast cancer who were treated with Halaven that was given as a clinical decision~     by patient's treating physician based on clinical status of a patient and proper indication~     of Halaven and to gain a better understanding of the use of Halaven in such Asian patients.~   "
24592|NCT03245099|"~     Non convulsive status epilepticus is a persistent change in behavioural and or mental process~     from baseline associated with continuous epileptiform activity in electroencephalograph,it~     occur in about 50 percent in patients with coma and convulsions and in 8-13 percent in~     intensive care unit patients~   "
24593|NCT03245086|"~     This study will compare Ferguson hemorrhoidectomy and THD in terms of one-year recurrence in~     a large population (N=492). Recurrence is defined as prolapsing internal hemorrhoids at~     physical examination performed by a colorectal surgeon.~   "
24594|NCT03245073|"~     In this project, investigators aim to investigate the effects of action observation therapy~     on pain, fear of movement, functional level and brain hemodynamics in patients with knee~     osteoarthritis. The study is unique in that this method, which has already been used for~     post-surgical or motor healing, aims at long-term administration for the first time with~     chronic pain and objective visualization of the results. This study will create a new~     perspective to understand the physiology of pain, which has attracted much interest in the~     literature in recent years, and will shed light on the studies that can be done in this~     regard. Participants' joint range of motion in the initial assessments will be measured by~     electro-goniometer, muscle strength assessment by JTech hand dynamometer at appropriate~     evaluation positions. In assessing pain, pain levels at rest and during activity will be~     questioned using Visual Analog Scale. Fear of movement of individuals will be assessed via~     Tampa Kinesiophobia Scale and functional levels will be assessed via Western Ontario and~     McMaster Universities Osteoarthritis Index (WOMAC) and the Timed Up and Go Test. Functional~     near infrared spectroscopy (fNIRS) will be used for evaluation of brain hemodynamics. The~     first group, will receive exercises with action observation therapy; and the second group~     will receive only exercises. The exercise programme will be administered under~     physiotherapist supervision for three days a week for six weeks. The evaluations will be~     repeated at the beginning of the study and at the end of the sixth week. Data obtained from~     the study will be analyzed using appropriate statistical methods.~   "
24595|NCT03245060|"~     Around one third of stroke survivors will have aphasia, which means they will have difficulty~     talking, understanding, reading or writing. The main aims of this study are to assess: [1]~     the acceptability of an existing psychosocial intervention, solution focused brief therapy,~     to people with varying presentations of aphasia; and [2] the feasibility of conducting a~     future definitive trial investigating clinical and cost effectiveness.~   "
24596|NCT03245047|"~     The prevalence of malnutrition among the elderly in Asia is high. The objective of this~     randomized, parallel, placebo controlled, double-blind study is to evaluate the effects of~     consuming an adult ONS plus dietary counseling (intervention group) for 180 days on~     nutritional status and unexpected hospital (re)admission, compared with a placebo supplement~     plus dietary counseling (control group).~   "
24597|NCT03245034|"~     This feasibility study develops methods for larger-scale research, evaluating the~     acceptability and perceived impact of a group acupuncture and acupressure intervention, as~     well as suitability of a self-report instrument. During their weekly training program, eleven~     OB residents at NYU Lutheran Medical Center will receive three sessions of auricular~     acupuncture therapy. (This resident population was previously anonymously surveyed and all~     expressed interest in participating in such a study). The Professional Quality of Life Scale~     (ProQOL) will be administered at 6 time points. A brief survey will also be given to assess~     participants' acceptance of the intervention as well as applicability of the ProQOL~     instrument. Additional feasibility-related outcomes include protocol compliance/withdrawals,~     adverse events, and time taken to complete intervention and surveys.~   "
24598|NCT03245021|"~     Firstline treatment for grade 13a Follicular Lymphoma using Opdivo (nivolumab) plus~     Rituximab: The 1st FLOR trial~   "
24599|NCT03245008|"~     The objective of this study is to verify the superiority of 16 weeks of MT-5547 treatment to~     placebo, as evidenced by the WOMAC pain score (the efficacy outcome measure), in patients~     with osteoarthritis of the knee or hip. Additional objectives of the study are to investigate~     the efficacy, safety, and pharmacokinetics of MT-5547 in long-term use.~   "
24600|NCT03244995|"~     Objectives:~      Objective 1: Examine the feasibility of the couple-based mind-body (CBMB) program in patients~     with high grade glioma (HGG) and their partners.~      Objective 2: Establish the initial efficacy of the CBMB program in patients and their~     partners regarding spiritual (primary), psychological and physical quality of life (QOL)~     (secondary) outcomes relative to a waitlist control (WLC) group.~   "
24612|NCT03244839|"~     The increasing demand of bariatric surgery requires ongoing improvement of the preoperative~     and post-operative care of morbidly obese patients. Outcome reporting in bariatric surgery~     mainly focuses on weight loss, improvement of co-morbidities and quality of life.~     Post-operative nutritional deficiencies are a complication of bariatric surgery, in~     particular after malabsorptive procedures. Deficiencies of protein, iron and vitamins B12 and~     D are frequently reported and may occur despite supplementation. Morbid obesity itself is~     associated with nutritional deficiencies as well, which become worsening after bariatric~     surgery. The occurrence of nutritional deficiencies has been reported in the literature but~     not in Taiwan. The goal of the current study is to determine the prevalence and incidence of~     nutritional deficiencies in diabetic patients underwent bariatric surgery and receiving~     standard supplementation in Taiwan.~   "
24601|NCT03244982|"~     Fluorescein angiography is a common procedure used in ophthalmology to diagnose and monitor~     diseases of the eye. The standard dose of fluorescein dye used in fluorescein angiography is~     500mg. It is common practice to give patients who have previously had an adverse reaction to~     fluorescein dye a half-dose, or 250mg, of fluorescein. It has been determined by our~     institution that anecdotally, there is no difference in image quality between the images~     created by a half-dose of fluorescein versus a full dose of fluorescein. Therefore, this~     study seeks to determine whether these doses are actually equivalent in terms of image~     quality. Patients who consent to participate in the study will be randomized to receive~     either a half or a full dose of intravenous fluorescein, and their images will be compared~     objectively using image correlation technology, and subjectively using a masked team of~     retinal surgeons. We hypothesize that there will be no significant difference between the~     images obtained using a half-dose versus a full dose of intravenous fluorescein.~   "
24602|NCT03244969|"~     The aim of the research is to identify structural tissue changes in the early fracture~     hematomas.~   "
24603|NCT03244956|"~     This is a multicentric prospective non-randomized phase II trial, with two independent arms:~     one for patients with RAS mutation and one for patients with BRAFV600E mutation.~   "
24604|NCT03244943|"~     Aim: This study evaluated the effects of non-surgical periodontal therapy (NSPT) on the~     cytokine profile and the correlation to clinical parameters of patients undergoing~     chemotherapy for breast cancer.~      Materials and methods: 40 patients were allocated: Chronic periodontitis patients (PC) (n=20)~     and breast cancer with chronic periodontitis patients (CAN/PC) (n=20). The clinical~     parameters: probing depth (PD), clinical attachment level (CAL), plaque index (PI), gingival~     index (GI) and levels of IFN-γ, IL-4, IL-10, TGF-β, IL-17, IL-2, IL-6, IL-1β and TNF-α in~     gingival crevicular fluid (GCF) were evaluated at baseline, 45 and 180 days after therapy.~   "
24605|NCT03244930|"~     Plerixafor, is added to mobilizing chemotherapy and G-CSF to overcome poor stem cell~     mobilization. We want to demonstrate that half of the commonly prescribed dose can be safely~     administered once as a single dose in first attempt leading to apheresis yields of >2 x 106~     CD34+ cells/kg body weight.~   "
24606|NCT03244917|"~     This is a 52-month study (8 months preparation; 36 months to conduct the trial; 8 months data~     analyses and manuscript preparation) of a cluster randomized controlled trial (RCT) of an~     intervention to improve infection management for suspected UTIs and LRIs among residents with~     advanced dementia (N=480; N=240/arm) living in NHs (N=24; N=12/arm). The NH is the unit of~     randomization as the intervention must be delivered at the facility level to avoid~     contamination and because this is how it would be employed in the real-world. Analyses will~     be at the patient level.~   "
24607|NCT03244904|"~     Participants will be consented into the study after they are found to meet the study~     inclusion criteria. The clinical staff will schedule a tissue biopsy and a blood draw for the~     participant to give NGS(Next-generation Sequencing).One is according to the germline mutation~     data to screen susceptible gene in SCLC(Small Cell Lung Cancer); two is to explore the~     extensive consistency detection of blood and tissues in patients with SCLC gene mutation~     information; three is to conduct dynamic monitoring of blood ctDNA(circulating tumor DNA) in~     patients with SCLC during treatment, by changing the types of mutations / abundance (for~     example: the clonal evolution of typical samples analysis) and change of tumor load, ,~     investigating the patients treatment effect , for the significant change of mutations, to~     study whether it can be used as molecular marker; four is to analyze of the molecular typing~     of SCLC, according to the clinical and pathological features of patients.~   "
24608|NCT03244891|"~     Heart Rate Variability (HRV) analysis has been studied in the critically ill patients~     although it is affected by several uncontrolled variables in the clinical conditions. The aim~     of this trial is to measure the effects of mildly reduced central volume and cyclic variation~     of intrathoracic pressure on the variables frequently used to describe the HRV.~   "
24609|NCT03244878|"~     This study evaluates a culturally-modified version of Thrive, a computerized Cognitive~     Behavior Therapy program to treat depressive symptoms, syndromes, and disorders among rural~     Montanans. Study participants will be randomized to either a wait-list treatment as usual or~     the Thrive program. After 8 weeks, the wait-list group will then receive Thrive. The primary~     assessment measure is the Patient Health Questionnaire-9.~   "
24610|NCT03244865|"~     Despite its limitations, fetal heart rate (FHR) tracing analysis is the best monitor of fetal~     well-being during labor or preparation for cesarean delivery. Current monitoring methods:~     transabdominal ultrasound and fetal scalp electrodes have limitations (tracing loss during~     fetal movement, potential to confuse maternal for fetal heart rate, inability to monitor~     during cesarean section or abdominal surgery) and, in the latter case, risks (infection,~     hematoma). A reliable, non-invasive monitor of the fetal heart rate that can be used during~     labor, non-obstetric and obstetric surgery during pregnancy is needed. Recent developments in~     use of maternal abdominal electrodes for extraction of the FHR and contraction information~     inform this study.~      LaborView®, developed by researchers at UF College of Medicine and OBMedical, is an~     FDA-approved non-invasive labor monitoring device. Refinement of the extraction algorithms~     continues, and that work is most effectively performed at UF, where the primary researchers~     and OBMedical are located.~      LaborView monitoring will be recorded from 150 subjects admitted to Labor and Delivery at~     UFHealth. Data will be simultaneously obtained from the standard labor monitor. These signals~     will then be analyzed off-line for comparison and refinement of algorithms.~   "
24611|NCT03244852|"~     The study aims to improve patient-specific anatomical targeting of the Deep Brain Stimulation~     for the treatment of intractable OCD.~   "
24613|NCT03244826|"~     This research study aims to evaluate the effectiveness of allowing patients who have had a~     hematopoietic cell transplant to receive some of their post-transplant care with a local~     oncologist rather than returning to the transplant center for all of their follow-up.~   "
24614|NCT03244813|"~     Our study aims to compare the effects of a standard care plan to one using adapted physical~     activity in patients with Parkinson Disease. Using actigraphy as an evaluation measure will~     allow the collection of quantitative and objective data related to activity in contrast to~     questionnaires which are more subjective and dependent on self-representation. In addition,~     the evaluation of the caregiver's actigraphy and hardship (Zarit scale) will provide~     interesting data from this population.~   "
24616|NCT03244787|"~     The investigators propose to develop, implement, and evaluate a novel Colorectal (CRC)~     screening patient navigator program for patients with Mental Health (MH) and /or Substance~     Use Disorder (SUD) receiving care at Massachusetts General Hospital Charlestown. The study~     will involve randomly assigning eligible patients to early intervention or usual care/delayed~     intervention groups. The investigators believe this random assignment is ethical because~     Patient Navigation (PN) is an extremely limited resource, and all patients identified as~     eligible could not be contacted by the navigators in a short period of time. Thus the~     investigators will randomly assign access to PN during the study period, and then allow all~     patients to be navigated and screened after the study period is over. As a result, all~     eligible patients will be referred for PN, but the timing of the referral will be randomly~     assigned.~   "
24617|NCT03244774|"~     In previous studies, we found that POF (A combination of oxaliplatin, fluorouracil and~     Paclitaxel) regimen appears to be of good efficacy and is well tolerated in patients with~     advanced gastric cancer. Apatinib is an orally antiangiogenic agent. It was approved and~     launched in China in 2014 as a 3rd-line treatment for patients with advanced gastric cancer.~     Therefore, investigators initialize this dose escalation phase I study to explore the safety~     of combination of apatinib and POF as first-line treatment for advanced gastric cancer.~     Investigators will analyze the maximum tolerated dose (MDT) and dose-limiting toxicity (DLT)~     of apatinib in this study.~   "
24618|NCT03244761|"~     Tracheostomy is often performed in patients after or anticipated prolonged mechanical~     ventilation, who are usually required oxygen therapy after discontinuation of mechanical~     ventilation.~   "
24619|NCT03244748|"~     Ventricular Tachycardia ablation in ischemic cardiomyopathy patients is required procedure in~     cases when anti-arrhythmic drugs failed. The concern is if adjunctive continuation amiodarone~     after ablation is needed.~   "
24620|NCT03244735|"~     Atkins diet is a nutritional regimen characterized by ad libitum protein and fat intake, but~     carbohydrate restriction. It is followed by millions of people around the word as a~     life-style, but in the last years was proposed as a treatment for the epilepsy, by its~     capacity to induce the state of ketosis.~      Since Authors observed that ketosis could be also useful in migraine, and migraine shares~     some pathophysiological features with cluster headache, The aim of the study is to test the~     efficacy of Atkins diet in Cluster Headache by an open label one harm observational study.~   "
24621|NCT03244722|"~     This study attempts to understand the association between maternal weight and child weight.~     Intended participants are both obese and lean women looking to get pregnant in the near~     future. Obese participants will be randomized to either a structured very low calorie diet or~     standard-of-care pre-natal dietary counseling. Lean participants will receive~     standard-of-care pre-natal dietary counseling. From pre-pregnancy through one-year after~     delivery, both mom and child will participate in tests looking at how their bodies process~     and store energy. Our hypothesis is that we affect the maternal-child weight association by~     changing the mother's pre-pregnancy metabolic make up.~   "
24622|NCT03244709|"~     Interleukin-6 (IL-6), a pro-inflammatory cytokine, has been found to have a crucial role in~     the pathogenesis of Giant cel arteritis (GCA). Based on this rationale, several recent~     studies demonstrated the efficacy of tocilizumab (TCZ), an anti-IL-6 targeted monoclonal~     antibody, for the treatment of patients with refractory GCA. Confirming previous reports,in a~     recent retrospective study the investigators successfully treated 10 patient with refractory~     GCA with TCZ. All patients achieved a complete disease remission evaluated by clinical,~     laboratory, and positron emission tomography (PET). In a considerable number of GCA patients~     treated with corticosteroids (CS) the therapy may be interrupted with no disease flares. No~     data are available on the management of patients achieving the remission with TCZ.~   "
24623|NCT03244696|"~     The investigators propose to conduct a randomized 6-month intervention study comparing~     cognitive functioning in individuals with relapsing-remitting multiple sclerosis assigned to~     either a physical activity or an active water-intake control group. Individuals will complete~     pre-, mid- and post-assessments of cognitive, physical, and behavioral functioning.~   "
24624|NCT03244683|"~     This is a single center, open label, randomized trial, involving 150 patients undergoing~     pancreatic surgery. Patients will be randomized at the time of enrollment to receive from 5-7~     days of ONS supplementation combined with resistance training and nutritional education~     compared to standard of care, consisting of nutritional education alone.~      This proof of concept study is intended to demonstrate the ability of pre-habilitation to~     improve patient-related outcomes following pancreatic surgery, specifically postoperative~     complications. The rationale for using the designated oral nutrient supplementation is to~     preserve muscle mass, and decrease weight loss.~   "
24625|NCT03244670|"~     A cohort study on incidence and progression of myopia in a group of medical students~   "
24626|NCT03244657|"~     To explore efficacy and safety of 0.5 mg conbercept ophthalmic injection for long-term~     treatment of polypoid choroidal vasculopathy (PCV) subjects.~   "
24627|NCT03244644|"~     This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3~     study of a microbiota suspension of intestinal microbes. Patients who have had at least two~     recurrences after a primary episode and have completed at least two rounds of~     standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI~     resulting in hospitalization within the last year may be eligible for the study. Subjects who~     are deemed failures following the blinded treatment per the pre-specified treatment failure~     definition may elect to receive an unblinded RBX2660 enema.~   "
24628|NCT03244631|"~     Comparison of lumbar plexus nerve block versus pericapsular injection for pain control during~     hip arthroscopy~   "
24629|NCT03244618|"~     Double blind parallel study to measure the efficacy of a toothpaste containing~     calcium-silicate/phosphate on dentinal hypersensitivity compared to a control toothpaste~     containing fluoride~   "
24630|NCT03244605|"~     The investigators performed a multi-centered, randomized, placebo-controlled, prospective~     clinical trial on the effect of comprehensive rehabilitation program to improve quality of~     life(QOL) and long-term survival of postoperative patients with early lung cancer. The~     investigators plan to enroll 236 cases in 3 years (118 cases for rehabilitation training plus~     traditional Chinese medicine (TCM), 118 cases for rehabilitation education plus placebo),~     expecting that comprehensive rehabilitation program has a better efficacy on improving QOL~     and long-term survival.~   "
24632|NCT03244579|"~     Study is an interventional clinical trial. Pregnant women (aged 25-40 years) diagnosed with~     GDM (by a 75-g oral glucose tolerance test at 24-28 weeks' gestation) will be recruited~     conveniently from Obstetrics and Gynecology clinic at the Jordan University Hospital and~     National Center for Diabetes, Endocrinology and Genetics, Amman, Jordan. A sample of 180~     pregnant women with GDM (60 women who do not use insulin and hypoglycemia medications, 60~     women who are treated with metformin, 60 women who are treated with insulin), who will meet~     the inclusion criteria and will be agreed to participate will be centrally randomized to~     follow carbohydrate counting dietary intervention, carbohydrate counting and DASH dietary~     intervention, and control dietary intervention.~   "
24633|NCT03244566|"~     Esophageal cancer is the eighth most common cancer around the world, with more than 450000~     new cases per year. Esophagectomy with radical lymphadenectomy (2-field lymphadenectomy) is~     the mainstay of treatment in many countries for patients with esophageal cancer. To improve~     the survival, 3-field lymphadenectomy combined with cervical lymphadenectomy was starTed in~     1980s. More potential positive lymph nodes were found during more extended lymphadenectomy,~     offering more accurate TNM staging, affecting consequent treatment.~     However，3-field-lymphadenectomy was associated with increased surgical morbidity and~     mortality. Positron emission tomography (PET) is used for detecting distant metastases and~     lymphatic involvement. The aim of the study is to evaluate the role of PET in predicting~     cervical lymph metastases of patients with thoracic esophageal squamous cell carcinoma, and~     to determine if we can use PET to guide future cervical lymphadenectomy.~   "
24634|NCT03244553|"~     This study will test prucalopride (a prokinetic drug currently approved by Health Canada for~     treatment of constipation) as a treatment for Ineffective Esophageal Motility (IEM). Adult~     patients with previously diagnosed IEM will be invited to participate by the investigators.~     The participants will take the study medication for 5 days and on the final day of medication~     undergo an esophageal manometry procedure at the Calgary Gut Motility Centre to measure~     esophageal function. Symptoms and side effects will be tracked at baseline and on Day 5.~   "
24635|NCT03244540|"~     All patients will be anaesthetized with spinal technique. Each patient will be treated with~     intravenous morphine - patient controlled analgesia (PCA). 2 of 3 groups of patients will~     receive ultrasound-guided transversus abdominis plane or quadratus lumborum block to treat~     postoperative pain. Postoperative pain will measured with visual-analogue scale (VAS). Total~     morphine consumption and time to the first demand will be noted. 1, 2, 6 months after surgery~     each patient will be called to assess neuropathic pain with Neuropathic Pain Symptom~     Inventory (NPSI).~   "
24636|NCT03244527|"~     In the past few years, Branched Chain Amino Acid (BCAA) supplements have gradually used on~     different groups. From training athletes, maintaining functions of healthy elders to~     preventing disabilities of people that can't do intense exercises. BCAAs are now considered~     to be able to prevent muscle atrophy and strength loss, also possible to increase strength~     and muscle mass if combined with resistance exercises. Stroke patients have difficulties with~     moving, which led to multiple disabilities, are more likely to have sarcopenia and strength~     loss. Furthermore, reducing the will of moving or walking. Recently, studies showed that~     combined BCAAs with resistance exercises can effectively increase muscle mass, thus commonly~     used on training athletes.~      Although aerobic exercises are proven to be more likely to improve walking ability of chronic~     stroke patients than traditional rehabilitation, BCAAs' effects are yet to be proven.~     Therefore, the aim of this study is to explore if BCAAs combined with moderate intensity~     exercises can prevent muscle atrophy, loss of strength and cardiopulmonary function.~      This is a randomized control trial. Participants are randomly assigned to either experiment~     or control groups. Both group received aerobic exercise (30 min in a session, 3 days a week,~     and for 8 weeks). Experiment group received BCAA supplement immediately after the exercise~     while the control group receive sham product (vitamins). The outcome measurements (including~     muscle mass, functional measures, and quality of life) are performed before (0-wk) and after~     (8-wk) the interventions, also after interventions in 3 months and 6 months for follow up.~   "
24637|NCT03244514|"~     There is no specific therapy for acute kidney injury. It is presumed that supportive measures~     improve the care and outcome of patients with acute kidney injury.~      The investigators hypothesize that the implementation of a bundle of supportive measures~     adapted to patients undergoing cardiovascular surgery reduces the occurence of AKI.~      A Randomized prospective multicenter trial is needed to investigate whether the~     implementation of the bundle of measures is effective to prevent AKI in high risk patients~     undergoing cardiac surgery. In this feasibility trial the investigators will analyze the~     compliance rate to the trial protocol in a multicenter, multinational cohort in preparation~     for a large randomized controlled trial.~   "
24638|NCT03244501|"~     The purpose of this study is to see if a new brain stimulation technique, static magnetic~     field stimulation (tSMS), which involves holding a static neodymium magnet over the scalp,~     can influence normal rhythms of brain activity.~   "
24639|NCT03244488|"~     It is estimated that by 2016, nearly 50% of HIV-positive individuals in the US will be aged~     50 or older, and up to 60% of those will experience some degree of cognitive impairment as~     they age. The purpose of this study is to evaluate the contribution of the neuronal~     cholinergic receptor system to the cognitive impairments seen in adults aging with chronic~     HIV Infection. By using anti-cholinergic challenge drugs to reversibly stress cognitive~     functioning, the investigators hope to understand whether the presence of the HIV virus in~     the brain impairs the neural system necessary for normal cognition, more than would be~     expected from normal cognitive aging.~   "
24640|NCT03244475|"~     Mild traumatic brain injury (mTBI) is a leading cause of sustained physical, cognitive,~     emotional, and behavioral deficits in OEF/OIF/OND Veterans and the general public. However,~     the underlying pathophysiology is not completely understood, and there are few effective~     treatments for post-concussive symptoms (PCS). In addition, there are substantial overlaps~     between PCS and post-traumatic stress disorder (PTSD) symptoms in mTBI. IASIS is among a~     class of passive neurofeedback treatments that combine low-intensity pulses for transcranial~     electrical stimulation (LIP-tES) with electroencephalography (EEG) monitoring. LIP-tES~     techniques have shown promising results in alleviating PCS individuals with TBI. However, the~     neural mechanisms underlying the effects of LIP-tES treatment in TBI are unknown, owing to~     the dearth of neuroimaging investigations of this therapeutic intervention. Conventional~     neuroimaging techniques such as MRI and CT have limited sensitivity in detecting~     physiological abnormalities caused by mTBI, or in assessing the efficacy of mTBI treatments.~     In acute and chronic phases, CT and MRI are typically negative even in mTBI patients with~     persistent PCS. In contrast, evidence is mounting in support of resting-state~     magnetoencephalography (rs-MEG) slow-wave source imaging (delta-band, 1-4 Hz) as a marker for~     neuronal abnormalities in mTBI. The primary goal of the present application is to use rs-MEG~     to identify the neural underpinnings of behavioral changes associated with IASIS treatment in~     Veterans with mTBI. Using a double-blind placebo controlled design, the investigators will~     study changes in abnormal MEG slow-waves before and after IASIS treatment (relative to a~     'sham' treatment group) in Veterans with mTBI. In addition, the investigators will examine~     treatment-related changes in PCS, PTSD symptoms, neuropsychological test performances, and~     their association with changes in MEG slow-waves. The investigators for the first time will~     address a fundamental question about the mechanism of slow-waves in brain injury, namely~     whether slow-wave generation in wakefulness is merely a negative consequence of neuronal~     injury or if it is a signature of ongoing neuronal rearrangement and healing that occurs at~     the site of the injury. Specific Aim 1 will detect the loci of injury in Veterans with mTBI~     and assess the mechanisms underlying functional neuroimaging changes related to IASIS~     treatment using rs-MEG slow-wave source imaging. The investigators hypothesize that MEG~     slow-wave source imaging will show significantly higher sensitivity than conventional MRI in~     identifying the loci of injury on a single-subject basis. The investigators also hypothesize~     that in wakefulness, slow-wave generation is a signature of ongoing neural rearrangement /~     healing, rather than a negative consequence of neuronal injury. Furthermore, the~     investigators hypothesize IASIS will ultimately reduce abnormal MEG slow-wave generation in~     mTBI by the end of the treatment course, owing to the accomplishment of neural rearrangement~     / healing. Specific Aim 2 will examine treatment-related changes in PCS and PTSD symptoms in~     Veterans with mTBI. The investigators hypothesize that compared with the sham group, mTBI~     Veterans in the IASIS treatment group will show significantly greater decreases in PCS and~     PTSD symptoms between baseline and post-treatment assessments. Specific Aim 3 will study the~     relationship among IASIS treatment-related changes in rs-MEG slow-wave imaging, PCS, and~     neuropsychological measures in Veterans with mTBI. The investigators hypothesize that Reduced~     MEG slow-wave generation will correlate with reduced total PCS score, individual PCS scores~     (e.g., sleep disturbance, post-traumatic headache, photophobia, and memory problem symptoms),~     and improved neuropsychological exam scores between post-IASIS and baseline exams. The~     success of the proposed research will for the first time confirm that facilitation of~     slow-wave generation in wakefulness leads to significant therapeutic benefits in mTBI,~     including an ultimate reduction of abnormal slow-waves accompanied by an improvement in PCS~     and cognitive functioning.~   "
24641|NCT03244462|"~     This study is planned to explore the effect of food on the oral pharmacokinetics, the~     intravenous pharmacokinetics and the absolute bioavailability of BAY1834845. Furthermore,~     this study will investigate the effect of BAY1834845 on the pharmacokinetics of orally~     administered methotrexate in healthy male subjects.~   "
24686|NCT03243877|"~     POC Medical Systems has developed a Point of Care system for the screening of breast cancer~     in the general population. Via a proprietary algorithm, the MammoAlert™ is expected to~     determine breast cancer's risk level for a subject by identifying the presence in plasma of~     known biomarkers. The present study aims to determine the Sensitivity and Specificity of the~     test in plasma samples of subjects of whom the status vis-à-vis breast cancer is known.~   "
24642|NCT03244449|"~     Around the world, the prevalence of type 2 diabetes mellitus (T2DM) has been increasing since~     the last two decades, with approximately 347 million patients with diabetes by 2013 according~     to the World Health Organization (WHO). This pronounced increase is due to an increase in the~     prevalence of obesity, reduction in physical activity levels, accelerated urbanization and~     aging of the population. In Colombia, T2DM ranks fifth in the main morbidity and mortality~     causes, including only deaths caused directly and without adding the strong influence that~     T2DM has on cardiovascular disease mortality.~      Insufficient tissue response to normal insulin concentrations, called insulin resistance, is~     one of the central pathophysiological mechanisms in the development of T2DM. However, there~     is currently no simple, practical, safe and reproducible method that allows the diagnosis or~     identification of insulin resistance, nor the follow-up to its evolution. At the moment, the~     gold standard for assessing the degree of insulin sensitivity or resistance is the~     hyperinsulinemic-euglycemic clamp, a laborious technique, of high cost and high technical~     difficulty, requiring specialized personnel and hospitalization. Non-invasive methods based~     on mathematical regressions, such as the Homeostatic Model Assessment (HOMA-IR), are~     imperfect and widely variable, and have not been validated in the Latin American population,~     less Still Colombian.~      Therefore, the development of new, easily obtainable quantitative tools for the diagnosis of~     insulin resistance is required. This requires not only the identification of new and better~     biomarkers, but also the determination of their diagnostic performance and operational~     characteristics.~      This project will investigate 3 molecular targets (myokines), novel and easy to measure, with~     high probability of being good biomarkers of insulin resistance. The research will include~     validation of its association with insulin resistance measured by the reference method, as~     well as its measurement in apparently healthy individuals. Finally, operator-receiver~     characteristics of each test will be analyzed, in order to propose a cutoff point for the~     diagnosis of insulin resistance.~   "
24643|NCT03244436|"~     We study the outcome and prequesties of emergency surgeries that were necessary following~     accidents in the pediatric cardiac catheterization lab~   "
24644|NCT03244423|"~     The use of antifibrinolytic agents such as to reduce blood loss in congenital cardiac surgery~     has been described in many studies~   "
24645|NCT03244410|"~     -  immune thrombocytopenic purpura is an acquired autoimmune disorder characterized by~          increased platelet destruction and decreased platelet number (cooper N et al 2006)~        -  recent studies have demonstrated that the pathogenesis of ITP envolves multifactorial~          autoimmune mechanisms of both humoral and cellular immunity and that acute and chronic~          forms may represent two distinct immunopathological disorders ( cooper N et al 2006) (~          Gern Sheimer T 2009 )~   "
24646|NCT03244397|"~     OBJECTIVE: To find out the effectiveness of physical therapy for stages I and II pelvic organ~     prolapse. DESIGN: Randomized, controlled and single blinded clinical trial. Patients will be~     randomly assigned to one of these groups: Experimental group: physical therapy + training in~     lifestyle advice; Control group: just training in means of lifestyle advice. In both groups~     several physical therapy assessments will be undertaken: 1st before intervention; 2nd~     immediately after completing intervention; 3rd, 4th, 5th and 6th after 3, 6, 12 and 24~     months. SUBJECTS: Women with previously untreated prolapse of stage I or II (confirmed by~     their gynaecologist using the POP-Q) in Príncipe de Asturias Hospital, provided that there is~     no contraindication for physical therapy, and after reading, understanding and freely signing~     an informed consent form. SAMPLE SIZE: A total of 120 subjects will be included in the study~     (60 subjects in each group). DATA ANALYSIS: A descriptive analysis will be done of all the~     variables, as well as bivariate analysis in order to find all the possible relationships~     between the variables. A confidence level of 95% (p<0.05) will be established for all the~     cases. Effectiveness will be evaluated by comparing between the two groups of the change in~     outcome variables between visits.~   "
24647|NCT03244384|"~     This randomized phase III trial studies how well pembrolizumab works in treating patients~     with bladder cancer that has spread from where it started to nearby tissue or lymph nodes.~     Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells~     to grow and spread.~   "
24648|NCT03244371|"~     Spontaneous recovery of patients infected with HCV is related to the development of a~     cytotoxic immune response that is executed by specialized white blood cells, the CD8+ T~     cells, which develop a virus-specific response. In addition, the natural killer (NK) cells~     provide a first-line innate cytotoxic response, which is pivotal for the spontaneous clearing~     of HCV. In patients where HCV infection settles chronically, CD8+ T lymphocytes and NK cells~     fall into a state of anergy induced by chronic viral challenge. This anergic state is also~     found in the case of HIV infection and exacerbated by HIV-HCV coinfection. The first~     therapeutic strategies against HCV were based on a treatment with interferon alpha, which had~     an antiviral but also immunosuppressive effect. In fact, this therapeutic strategy was unable~     to help the recovery of the patient's immune system that would be expected after HCV cure.~     However, interferon-free therapeutic strategies combining first generation direct antiviral~     agents (DAA) showed a positive effect on HCV antiviral immunity, by enhancing the~     proliferative response of CD8+ T cells and the cytotoxic and proinflammatory responses of NK~     cells in HCV monoinfected patients (4, 5). Since HCV-targeted therapies based on combinations~     of the latest generation of DAA have nearly 100% cure rates and enable faster viral~     suppression over shorter treatment times, a positive impact of these regimens on antiviral~     immunity is plausible. This possibility would be particularly interesting in HIV-HCV~     co-infected patients, where reactivation of the innate antiviral immunity may contribute to~     immune defenses against both viruses. Moreover, it has been previously reported a moderate~     but significant and sustained decline of HIV-1 DNA in CD4 T cells from HIV-1/hepatitis C~     virus-coinfected patients receiving highly active antiretroviral therapy and treated with IFN~     alpha/ribavirin.~      To date, the real impact on antiviral immunity of treatment as well as on HIV reservoir with~     the latest generation of DAA was not measured in HIV-HCV co-infected patients.~      The aim of this study is to analyze the impact of the cure of hepatitis C on the HIV DNA~     reservoir and antiviral function of CD8+ and NK cells in a subgroup of patients receiving the~     latest generation DAAs for treatment of HCV infection, as part of a program for a reduction~     of the prevalence of chronic hepatitis C patients co-infected HIV-HCV set up within the~     Immuno-Hematology Service of the Sainte Marguerite Hospital (Research in routine care-Ethics~     committee Approval Sud- Méditerranée I ID RCB 2015-A01913-46/ Principal Investigator: Dr I~     Poizot-Martin).~      The analysis of HIV DNA, NK and CD8+ T lymphocyte antiviral immune response prior, during and~     after anti-HCV treatment will need the collection of a biobank. Indeed, 25 mL peripheral~     blood will be collected at treatment initiation, during an interim assessment, at the end of~     treatment and six months post-treatment, for a total of 100 ml of additional blood~     collection. These analyzes will be performed by Dr C Tamalet for HIV DNA IHU-Méditerranée~     Infection, and the team of Prof. E Vivier, DHU- Marseille Immunopole for NK and CD8+ T~     lymphocyte antiviral immune response.~   "
24649|NCT03244358|"~     To evaluate the efficacy and safety of Epalrestat in the treatment of metastatic triple~     negative breast~   "
24650|NCT03244345|"~     Psychiatric disturbances, notably depression, occur frequently as co-morbid conditions with~     epilepsy. A complex, probably bidirectional relationship between epilepsy and depression has~     been postulated. Both epilepsy and depression also interact with stressful life events, but~     only some patients develop these disorders after a stressful event, indicating the~     possibility of a vulnerable population. Animal and human studies have looked at the role of~     brain derived neurotrophic factor (BDNF) in this context. Low serum and/or CSF levels of BDNF~     are associated with higher incidence of depression, and thus indicate the vulnerable~     population.~      Animal studies of BDNF have looked specifically at the relation between epilepsy and~     depression using a novel double hit design. After chronic stress exposure, measurement of~     BDNF levels allowed identification of 2 sub-groups: a vulnerable population and~     non-vulnerable population. A second hit of kainic acid induced status epilepticus (SE) was~     then applied to both the vulnerable and non-vulnerable populations. Only the vulnerable~     population exposed to SE developed a depression-like profile.~      In a proof of concept approach we propose studying the relation between epilepsy, depression,~     anxiety and stressful life events, using serum BDNF levels in patients with pharmacoresistant~     epilepsy. Evaluation of epilepsy type and co-morbid psychiatric profile will be performed in~     150 subjects. By comparing BDNF levels for different epilepsy subgroups to BDNF levels for~     healthy subjects and for depressed subjects without epilepsy, we hope to identify whether~     risk of co-morbid depression and/or anxiety in epilepsy may be predicted using BDNF levels.~     In addition, in a subgroup of 25 patients, we propose a pilot study in which cortisol and~     C-reactive protein will be measured in addition to BDNF.~   "
24651|NCT03244332|"~     Prospective investigations into the role of hemostatic factors in the risk of variceal~     bleeding among children with chronic liver disease (thromboelastometry e.g) is still~     required. A better understanding of these factors would permit better risk stratification and~     targeted prophylaxis or therapy.~   "
24652|NCT03244319|"~     1. objectives: The primary aim of ENAVLE is to explore the efficacy of edoxaban in patients~          with post mitral valve repair or bioprosthetic valve implantation~        2. Primary / Secondary Endpoint~      1) Efficacy Endpoint Evaluation: Occurrence of thromboembolic events and any thrombus at~     repaired ring or bioprosthetic valves detected by follow up echocardiography or 3D CT scan~      2) Safety Endpoint Evaluation~        -  Dysfunction of treated valve caused by thrombosis on echocardiography or 3D CT scan~        -  Major or minor bleeding described in safety outcomes~   "
43036|NCT03003455|"~     The purpose of this study is to determine whether nasal intubation over a bougie placed via a~     nasal trumpet will decrease nasal trauma when compared to the conventional technique of blind~     nasal endotracheal tube passage.~   "
24653|NCT03244306|"~     Patients with relapsed or refractory leukemia often develop resistance to chemotherapy and~     some patients who relapse following CD19 directed therapy relapse with CD19 negative~     leukemia. For this reason, the investigators are attempting to use T-cells obtained directly~     from the patient, which can be genetically modified to express a chimeric antigen receptor~     (CAR) to CD22, a different protein from CD19, expressed on the surface of the leukemic cell~     in patients with CD22+ leukemia. The CAR enables the T-cell to recognize and kill the~     leukemic cell through the recognition of CD22, a protein expressed on the surface of the~     leukemic cell in patients with CD22+ leukemia. This is a Phase 1 study designed to determine~     the safety and feasibility of the CAR+ T - cells and the feasibility of making enough to~     treat patients with CD22+ leukemia.~   "
24654|NCT03244293|"~     To evaluate the discriminative power of BIS monitoring to classify the degree of mental state~     associated with the PCT graded sepsis cascade, and to assess its utility for monitoring the~     improvement or deterioration of sepsis.~   "
24655|NCT03244280|"~     A Study of the Systemic Absorption of Once Daily MOB015B when Applied for 28 Days in Subjects~     with Moderate to Severe Onychomycosis of the Toenails.~   "
24656|NCT03244267|"~     The purpose of this study is to explore the impact of using a smartphone app reminder on~     medication adherence twice daily in adults prescribed 81 milligrams of aspirin for 35 days as~     anti-thrombotic therapy after knee or hip arthroplasty.~      This study will randomly assign participants to get usual postoperative care which is~     teaching with verbal instructions and printed information about taking the aspirin at the~     time of discharge, or to have an app on your smartphone with preset reminders in addition to~     usual postoperative discharge teaching after surgery.~   "
24657|NCT03244254|"~     A prospective, longitudinal study meant to compare blood levels of I-FABP in pediatric celiac~     patients during diagnosis to levels under gluten free diet, it's correlation with traditional~     serology testing and questionnaire regarding patient responsiveness to the gluten free diet,~     and in comparison to a control group.~   "
24658|NCT03244241|"~     Hyperglycemia during admission is associated with increased rate of complications and longer~     hospital stays, thus insulin treatment is recommended for all diabetes patients with~     hyperglycemia. Inpatient studies of non-critically ill patients show better glycemic control~     with the use of basal-bolus insulin therapy compared to sliding scale insulin therapy, but~     increased rates of hypoglycemia. The investigators hypothesize that basal-bolus insulin~     therapy with a new ultra-long-action basal insulin can treat hyperglycemia more efficiently~     than sliding scale insulin, with few episodes of hypoglycemia.~   "
24659|NCT03244228|"~     Phase 1, first in human, two-part, single centre, placebo-controlled, single and multiple~     ascending dose trial in healthy younger and elderly adult subjects, with an open-label,~     randomised, crossover arms to assess the effect of food on bioavailability.~   "
24660|NCT03244215|"~     The primarily goal of the research is to better understand progression of disease in patients~     who present with an acute stroke to the Hamad General Hospital (HGH) stroke and Transient~     Ischemic Attack (TIA) clinic. The investigators are specifically interested in patients who~     have diabetes and have a stroke.~      The patients enrolled into the research will have detailed clinical evaluation and their~     imaging studies (MRI and Doppler) will be reviewed. After informed consent, subjects will be~     examined in the stroke Ward /TIA clinic upon recruitment, and later at less than 48 hours of~     recruitment (blood extraction and urine samples) and for follow up visits at 1 month+/-7 days~     (clinical evaluation and to extract blood and urine samples), at 3 months (telephonic~     conversation only) and at 1 year (clinical and repeat MRI brain).~      During the initial visit at the ward the investigators will collect serum and plasma for~     proteomic and metabolomic studies. These will be repeated at less than 48 hours and at 1~     month+/-7 days. Investigators will test the effects of risk factors such as diabetes/stroke~     on the endothelial procoagulant and inflammatory state at onset and evaluate if best medical~     control leads to improvement in such markers.The repeated studies will determine if better~     management and presence of certain blood biomarkers can predict or translate to slower~     progression of disease and correlate it with clinical status.~   "
24661|NCT03244202|"~     Health care providers (HCP) are increasingly using genomic sequencing (GS) to target~     treatment for patients. However, GS may incidentally reveal inherited risks for thousands of~     current and future diseases. Guidelines recommend HCP inform patients of incidental GS~     results. No decision aid (DA) exists to guide patients' decisions about which incidental GS~     results they wish to learn. This study will evaluate whether the DA followed by genetic~     counselling (GC) reduces decisional conflict compared to GC alone in a randomized controlled~     trial (RCT) with 128 patients with a family history of cancer, who have had a negative~     genetic test and may eligible for GS. A qualitative component with a subset of participants~     (n=40) will explore patients' preferences for the types of incidental results they wish to~     receive and their decision making process.~   "
24662|NCT03244189|"~     A randomized clinical trial to investigate the impact of increased fluid intake and increased~     urine output on the recurrence rate of urinary stone disease (USD) in adults and children.~     The primary aim of the trial is to determine whether a multi‐component program of behavioral~     interventions to increase fluid intake will result in reduced risk of stone disease~     progression over a 2‐year period.~   "
24663|NCT03244176|"~     To evaluate the feasibility of adding induction and maintenance Avelumab to the standard~     combination of R-CHOP in patients with stage II, III and IV diffuse large B cell lymphoma~     (DLBCL)~   "
24664|NCT03244163|"~     This study aims to compare the overall rate of endoscopic clearance of complicated bile duct~     stones by Spyglass DS peroral cholangioscopy guided holmium:YAG laser/electrohydraulic~     lithotripsy versus conventional BML.~   "
24665|NCT03244150|"~     The Youth and Sport Study (YSS) is a 20-22-year follow-up study of Danish teenagers born~     between 1964 and 1969. Baseline data originate from two different studies carried out in 1983~     and 1985, and the follow-up study was carried out in 2005.~   "
24687|NCT03243864|"~     The study's primary objective is to determine plasma and dialysis fluid concentrations in~     patients prescribed ceftazidime-avibactam as the standard treatment for their infection and~     requiring continuous venovenous hemodiafiltration (CVVHDF) as part of the standard treatment~     for acute or chronic renal failure. Secondarily, the study will evaluate the pharmacokinetics~     of ceftazidime-avibactam in these patients on CVVHDF. The study will also determine if the~     prescribed dose meets pharmacodynamic targets.~   "
24666|NCT03244137|"~     Chronic obstructive pulmonary disease is a leading cause of mortality worldwide.~      It is a systemic disease which includes pulmonary, cardiac, muscular, digestive and cognitive~     impairments.~      Pulmonary rehabilitation is a symptomatic treatment to reduce dyspnea and functional~     incapacity. However, it effects on cognitive dysfunction are not well known.~      The aim of this study is to assess the effects of a comprehensive pulmonary rehabilitation~     program on cognitive dysfunction in patients with severe to very severe chronic obstructive~     pulmonary disease using the Montreal Cognitive Assessment tool.~   "
24667|NCT03244124|"~     Treatment clinical trial, randomized, controled, parallel, double-blinded, with four groups,~     that aims to evaluate the best application strategy when using a new Universal Adhesive~     system, Futurabond Universal (VOCO GmbH, Germany). Volunteers will be selected and~     recruited,following inclusion criteria and pre-established exclusion. All volunteers will be~     informed and sign a term of clarification and consent. 50 enrolled patients will receive 200~     Class V dental restorations, made in four different ways, one from each experimental group,~     using the same universal self-etching adhesive system, which is the tested material in this~     study. Non-carious cervical lesions will receive the applied adhesive system in 4 different~     protocols separated by groups. Group Self Etching (SET) (control): no conditioning, the~     adhesive system will be used in 50 teeth, according to the manufacturer's instructions, in~     the self-etching mode. The adhesive system will be brushed during 20 seconds in the cavity,~     will be air-dried during 5 seconds, and activated during 10 seconds with Light Emission Diode~     (LED) light; Group SEE (Selective enamel etching): 37% phosphoric acid will be applied during~     30 seconds, only in enamel in 50 teeth. This acid will be removed using water, the cavity~     will be air-dried, and then, the adhesive will be applied according to the manufacturer's~     instructions, as described in group SET; Group ERDry (Etch& Rinse Dry): 37% phosphoric acid~     will be applied during 30 seconds, only in enamel and during 15 seconds only in dentin, in 50~     teeth. This acid will be removed using water, the cavity will be air-dried, keeping dentin~     dry, and then, the adhesive will be applied according to the manufacturer's instructions, as~     described in group SET; Group ERWet (Etch& Rinse Wet): 37% phosphoric acid will be applied~     during 30 seconds, only in enamel and during 15 seconds only in dentin, in 50 teeth. This~     acid will be removed using water, the cavity will be air-dried, keeping dentin wet, and then,~     the adhesive will be applied according to the manufacturer's instructions, as described in~     group SET. After applying the adhesive, the restorations will be made with composite resin,~     and evaluated every 6 months for pain assessment, shape, staining or recurrent caries, using~     scores. To determine in which group each tooth will be enrolled, the authors will randomize~     the teeth.~   "
24668|NCT03244111|"~     Objective: There have been a wide variety of interventions to assist with cognition and~     memory of older adults; however, it is often unclear if the interventions have an impact on~     daily life memory performance and goal attainment. The objectives of this study are to~     examine: 1) whether an intervention that involves a simple memory tool assists with daily~     life memory performance and goal attainment of older adults; and 2) whether the intervention~     has a different effect for individuals with healthy cognition versus individuals with mild~     cognitive impairment (MCI).~      Research Questions: Can a simple memory tool assist with daily life memory performance and~     goal attainment for older adults? Does the simple memory tool have a different effect for~     individuals with healthy cognition and individuals with MCI? Methods: The study will use a~     mixed 2 X 3 design with cognition (healthy, MCI) as the between subjects factor and time~     (session 1, 2, 3) as the within-subjects factor. There will be 40 older adults who have~     healthy cognition and 20 older adults who have MCI. The study will consist of 3 sessions for~     each participant. The sessions will be held once a week and incorporate: a) the Montreal~     Cognitive Assessment (MOCA) to determine level of cognition (healthy, MCI); b) the~     Prospective and Retrospective Memory Questionnaire (PRMQ) to help determine daily memory~     performance; c) a memory recall test for recent daily events to help determine daily memory~     performance; d) the goals of the participants using the Goal Attainment Scaling (GAS); and e)~     the development of checklists that are tailored to address goals. In between the sessions,~     participants will perform the checklists and update the diary with notes of what they want to~     remember on a daily basis. The hypotheses are that: 1) memory performance (i.e., measured~     with memory recall of daily events and PRMQ), and goal attainment will increase from session~     to session; 2) participants with healthy cognition will have better memory performance and~     goal attainment than participants with MCI; and 3) participants with healthy cognition will~     have greater gains in memory performance and goal attainment than participants with MCI.~   "
24669|NCT03244098|"~     To improve spinal cord injury (SCI) rehabilitation through stronger informal caregiving, the~     proposed study will modify and evaluate a telehealth Transition Assistance Program (TAP) for~     informal caregivers of individuals with SCI during the transition from hospital to home. The~     TAP was previously developed for stroke caregivers and has been found to decrease caregiver~     strain and depression. In the proposed study, the TAP will be modified for SCI and~     implemented at a state-of-the-art SCI rehabilitation facility with a very high volume of SCI~     treatment and with telehealth technology already in place through which to test the~     intervention.~   "
24670|NCT03244085|"~     This is a nonrandomized, open-label, no-control, dose-escalation Phase 1b trial in 18~     patients with chronic HBV infection to determine the safety, preliminary efficacy, and~     pharmacokinetics (PK) of QL-007 after administration over 28 days of multiple oral doses in a~     fasted state at the following planned dose levels: 200 mg/day (100 mg two times a day (BID)),~     400 mg/day (200 mg BID), then 600 mg once daily (QD), with 6 patients for each cohort.~   "
24671|NCT03244072|"~     Intracameral injection of 0.1% moxifloxacin solution after cataract surgery to prevent~     endophthalmitis~   "
24672|NCT03244059|"~     This is intended to be an initial proof-of-concept study to show feasibility, validate~     assays and approaches, and explore dosing and safety of belimumab in pulmonary emphysema~     patients who have clinically relevant (and quantifiable) autoimmune responses. The primary~     goal is to determine effects of belimumab on levels of autoantibodies against glucose~     regulated protein 78 (GRP78) among patients with pulmonary emphysema attributable to~     cigarette smoking. The investigators hypothesize that belimumab treatment will safely reduce~     circulating levels of autoantibodies that are associated with emphysema, and comorbidities of~     this lung disease, including atherosclerosis.~   "
24673|NCT03244046|"~     The aim is to test whether the psychotherapeutic intervention Somatic Experiencing targeting~     Post Traumatic Stress Disorder (PTSD) symptoms will have an additional positive effect on the~     outcomes of guided physiotherapy against chronic back pain development.~   "
24674|NCT03244033|"~     Preventing contextual errors requires heightening clinician responsiveness to clues that~     there are contextual factors during the clinical encounter, in real time. These clues, termed~     contextual red flags are evident in two sources: the medical record and from patients~     directly. An effective intervention would prompt clinicians to determine whether there are~     underlying contextual factors that could be addressed in the care plan, averting contextual~     error. This desirable process is termed contextual probing.~      While clinical decision support (CDS) has been used to provide physicians with timely~     biomedical information at the point of care to prevent errors and promote appropriate care,~     this technology also affords an opportunity to draw physician attention to both contextual~     red flags and contextual factors in order to avert contextual errors. This study assesses the~     potential of contextualized CDS to improve contextualization of care through a randomized~     controlled intervention trial, with assessment measures of both patient health care outcomes~     and averted costs associated with overuse and misuse of medical services. The three~     hypotheses are that CDS:~        1. Reduces contextual error: CDS tools that inform clinicians of contextual factors and~          prompt them to explore contextual red flags should result in a reduction in contextual~          error.~        2. Improve health care outcomes: Contextualized CDS predicts improved health care outcomes~          defined as a partial or full resolution of the contextual red flag (e.g. elevated HgB~          A1c) after the index visit.~        3. Reduces avoidable health care costs: Contextualized CDS is associated with a reduction~          in misuse and overuse of inappropriate or unnecessary medical services.~   "
24688|NCT03243851|"~     A phase 2 clinical trial for the efficacy and safety of low dose Temozolomide plus metformin~     as combination chemotherapy compared with low dose Temozolomide plus placebo in patient with~     recurrent or refractory Glioblastoma~   "
24675|NCT03244020|"~     Aspirin and low molecular weight heparin (LMWH) are both commonly employed pharmacologic~     methods of venous thromboembolism (VTE) prophylaxis after orthopaedic surgery. Data comparing~     these two methods of VTE prophylaxis in patients undergoing pelvic/lower extremity~     orthopaedic surgery for malignancy are lacking, however, as compared to the data and~     guidelines present for VTE chemoprophylaxis after joint arthroplasty and hip fracture~     surgery. In this clinical trial, our specific aim is to compare the post operative incidence~     of VTE between patients receiving aspirin and LMWH after pelvic/lower extremity orthopaedic~     oncology procedures.~   "
24676|NCT03244007|"~     We evaluate the intraoperative optical coherence tomographic (OCT) images of eyes with~     idiopathic macular hole (MH) or lamellar macular hole whether the intraoperative OCT findings~     will affect postoperative visual outcome.~   "
24677|NCT03243994|"~     Aim: To investigate whether patients with pulmonary hypertension have reduced absorption~     capacity compared to COPD patients without cor pulmonale potentially due to venous~     obstruction in the portal vein system.~      The presence of cor pulmonale was determined by echocardiography. The concentration of~     D-xylose and zinc were measured in peripheral blood one, two and three hours after ingestion~     and used as markers of absorption. Furthermore, urine was collected for five hours to~     determine the amount of excreted D-xylose.~   "
24678|NCT03243981|"~     In this exploratory study, we hope to learn if treatment of broadband light with infrared~     light can alter the molecular pathways associated with aging. Secondary exploratory objective~     is to see if there are any visible effects of this light treatment on human skin.~   "
24679|NCT03243968|"~     Cardiovascular diseases (CVD) are responsible, throughout the world, for high mortality rates~     and cardiovascular morbidity. Endothelial dysfunction is the earliest marker of clinical~     atherosclerosis development. Human studies show that endothelial and microvascular~     dysfunction are independent predictors of ischemic cardiovascular events and long-term~     prognosis. The study´s objective is to evaluate the endothelial and peripheral~     microcirculation changes by venous occlusion plethysmography (VOP),~     nailfoldvideocapillaroscopy (NVC) and serum biomarkers in patients with myocardial ischemia~     detected by scintigraphy and normal coronarography.~   "
24680|NCT03243955|"~     Transcutaneous electrical acupoint stimulation (TEAS) is an emerging technology for~     non-invasive neuromodulation that has broad potential implications and warrants further~     study. The investigators' clinical experience from the University of California, Los Angeles~     (UCLA) Center for East-West Medicine (CEWM) has also demonstrated that TEAS can be used as an~     effective self-care tool for patients with chronic illness who do not have the time or~     resources for frequent acupuncture treatments. Chronic constipation is the chosen area of~     study because of the large population with a substantial impairment in health-related quality~     of life and work productivity. The investigators have recently completed a randomized~     controlled trial (RCT) demonstrating the benefit of perineal self-acupressure on quality of~     life measurements in this population, which supports investigation into other~     acupuncture-based self-care interventions. Given these findings, the investigators~     hypothesize that home patient-administered TEAS can provide measurable improvements in both~     symptom severity and health related quality of life.~   "
24681|NCT03243942|"~     The fundamental hypothesis of this project is that real-time intracardiac pressures can be~     monitored and quantified noninvasively in humans using a novel contrast-enhanced ultrasound~     technique called subharmonic-aided pressure estimation (SHAPE).This study will use contrast~     echocardiography to assess the accuracy of SHAPE compared to simultaneously acquired~     intracardiac pressures measured invasively during cardiac catheterization. This study is~     designed to verify that contrast echocardiography using the SHAPE method, already proven in a~     canine model and tested in a human pilot study can be used as a surrogate for cardiac~     catheterization with sufficient accuracy to allow clinical applicability in humans.~   "
24682|NCT03243929|"~     The purpose of the Translation of District Sun Safe Policies to Schools study was to test~     whether schools need assistance to facilitate the implementation of school district~     board-approved sun safety policies by individual elementary schools. The intervention is~     expected to produce a change in practices at the school level and to improve the sun safety~     behavior of children attending the intervention schools compared to control schools. A group~     of 40 school districts in Southern California that adopted board policy 5141.7 for sun safety~     provided 118 schools that were randomized to a intervention condition or to an attention~     control condition. The primary outcome is change in school-level sun safety practices based~     on 10 Centers for Disease Control and Prevention (CDC) categories for policy change (i.e.,~     sunscreen use, UV protective clothing, hats, student education, teacher education, provision~     of shade, scheduling to avoid peak UV exposure, parent outreach, resource allocation for sun~     safety, and an accountability system). This primary outcome was assessed by a survey of the~     principal and one teacher at each school (N=118 principals and 113 teachers at pretest).~     Parents (N=1770 at pretest) of children attending the schools completed a self-report measure~     assessing the secondary outcomes of change in individual-level sun safety behavior of their~     elementary school aged children and number of communications received from the school~     regarding sun safety. Assessment of principals, teachers and parents occurred at pretest,~     just prior to randomization, and at a posttest 20-months after the pretest. One Parent~     Teacher Association (PTA) representative per school was contacted to assess PTA involvement~     in intervention activities related to sun safety.~      The primary hypothesis was stated for the effectiveness of the intervention condition at~     increasing school-level sun safety practices consistent with the sun safety policies of the~     school districts and read, H1: At follow-up, a greater percentage of schools in the~     intervention condition will implement at least one component of the school district sun~     safety policy compared to schools randomized to the attention-control condition.~   "
24683|NCT03243916|"~     Hepatocellular carcinoma is a highly malignant tumor that is progressing rapidly. Hepatic~     arterial embolization chemotherapy (TACE) is a common method for the treatment of~     unresectable of hepatocellular carcinoma.But for patients with > 10cm hepatocellular~     carcinoma, the intervention effect was not satisfied.The cyberknife is a kind of stereotactic~     radiotherapy which can track the movement of tumor and monitor the position deviation of~     tumor in real time.This stuy is aimed to observe the efficiency and safety of the combination~     of TACE and cyberknife in the treatment of massive hepatocellular carcinoma.~   "
24684|NCT03243903|"~     In this study, QS-M needle-free injector and needle-insulin pen were used as a drug carrier~     to control blood glucose in type 2 diabetic patients.The efficacy and safety of QS-M~     needle-free injector and needle-insulin pen were evaluated and compared.This is a~     needle-insulin pen as control group, using a prospective, multicenter, randomized, open,~     parallel grouping study.~   "
24685|NCT03243890|"~     Aortic stenosis is a common heart valve disease and due to the growing elderly population the~     prevalence is increasing. The disease is progressive with increasing calcification of the~     valve cusps. A few attempts with medical preventive treatment have failed, thus presently the~     only effective treatment of aortic stenosis is surgery. This study will examine the effect of~     menaquinone-7 (MK-7) supplementation on progression of aortic valve calcification (AVC). The~     investigators hypothesize that MK-7 supplementation will slow down the calcification process.~   "
24689|NCT03243838|"~     Triple-negative breast cancer (TNBC) is a special type of breast cancer, endocrine therapy~     and targeted therapy are completely ineffective, chemotherapy is currently the only effective~     treatment. How to improve postoperative pathologic complete response（pCR）of neoadjuvant~     chemotherapy is critical problem to prolong overall survival (OS) of TNBC patients. Apatinib~     is a new oral small molecule tyrosine protease inhibitor, it is effective in inhibiting~     angiogenesis with a very low concentration. So the standard neoadjuvant chemotherapy regimen~     of docetaxel and carboplatin combined with apatinib may improve the postoperative PCR and OS~     of TNBC patients. Safety and tolerability assessed by number of grade 3 and 4 toxicities and~     hospitalizations.~   "
24690|NCT03243825|"~     For stage Ib2-IIa2 cervical cancer patients, neoadjuvant therapy followed by radical~     hysterectomy and pelvic lymphadenectomy is one of the managements. Post-operative concurrent~     chemo-radiotherapy is necessary if the patients have high-risk factors, including positive~     surgical margin, parametrium and pelvic nodes. Our previous retrospective study showed that~     combination of neoadjuvant chemotherapy and brachytherapy reduced the proportion of~     post-operative concurrent chemo-radiotherapy compared to neoadjuvant chemotherapy alone.~   "
24691|NCT03243812|"~     Background : Sickle cell patients have profound remodeling of their muscle microcirculation~     networks with signs of amyotrophy. However, the consequences of these muscle alterations on~     the functional status of muscles are unknown. In addition, whether the poor physical fitness~     of sickle cell patients can be attributed, at least partly, to an hypothetical muscle~     dysfunction has never been tested.~      Purpose : this study will compare the muscle function of legs between sickle cell patients~     (SS and SC genotypes) and healthy individuals (AA genotype) before, during and after a short~     localized muscle endurance exercise.~      Abstract : Very recently, a study reported large differences between the muscle~     microcirculation networks of sickle cell patients compared to healthy individuals with~     decreased capillary density and higher proportion of large capillaries in the former~     population. In addition, the same study showed signs of amyotrophy in sickle cell patients.~     However, the muscle function of sickle cell patients has not been investigated and one may~     suggest that muscle dysfunction could participate in the decrease of physical fitness, in~     association with the hematological and hemorheological disorders, already reported in this~     population. The hypothesis is that muscle fatigue during a short localized muscle endurance~     exercise should be higher in sickle cell patients compared to healthy individuals, due to a~     greater recruitment of glycolytic fibers and a faster decrease of muscle oxygenation during~     exercise.~   "
24692|NCT03243799|"~     The primary aim is to evaluate the effectiveness of an intervention based on a~     psychoeducational program carried out by primary care nurses, to improve the rate of~     remission and response of depression in patients with physical chronic illness (diabetes,~     COPD, asthma and / or ischemic heart disease). Secondarily, to assess the cost-effectiveness~     of the intervention, the effectiveness to improve the control of physical pathology, the~     impact on quality of life and the feasibility of the intervention.~      Methods: a multicentre, randomized clinical trial, with two groups and 1 year follow-up~     evaluation. Economic evaluation study. We will study 504 patients (252 in each group), over~     50 years assigned to 25 primary care teams (PC) from Catalonia (urban, semi-urban and rural)~     with major depression and with at least one of the diseases: diabetes mellitus type 2,~     chronic obstructive pulmonary disease, asthma, and / or ischemic heart disease. They will be~     distributed randomly into two groups. The intervention group will participate in~     psychoeducational groups: 12 weekly 90-minute sessions led by two nurses from PC, consisting~     of health education on chronic physical illness and depressive symptoms.~      Main measurements: clinical remission of depression and / or response to intervention (Beck~     depression inventory: BDI-II). Secondary measures: improvement in control of chronic disease~     (blood test and physical parameters), drug compliance (test Morinsky-Green and number of~     packaging), quality of life (EQ-5D), medical service utilization (appointments and hospital~     admissions due to complications) and feasibility of the intervention (satisfaction and~     compliance). Evaluations will be masked and conducted at 0, 3, 6 and 12 months.~   "
24693|NCT03243786|"~     The purpose of this study is to examine the impact of a lifestyle intervention. The study~     will examine the Stay on Track program, dietary and activity patterns, body composition,~     biomarkers and quality of life in breast cancer patients undergoing radiation therapy.~   "
24694|NCT03243773|"~     Acute heart failure is a life threatening condition requiring rapid diagnosis and treatment.~     However, the differentiation between heart failure and other conditions presenting with acute~     dyspnea is notoriously difficult in the emergency room. Point-of-care lung ultrasound is a~     simple, rapid and noninvasive technique directly visualizing fluid content in the lung as~     evidence for acute heart failure. A number of publications showed the diagnostic utility of~     lung ultrasound in the diagnosis of heart failure, but many open questions remain.~      The goal of this study is to evaluate the diagnostic accuracy of lung ultrasound to predict a~     cardiac origin of dyspnea in unselected patients in the emergency room as compared to~     standard evaluation. Further goals are to evaluate if lung ultrasound provides additional~     diagnostic information as compared to clinical examination, NT-proBNP and chest X-ray, to~     compare the diagnostic accuracy of lung ultrasound in different patient subgroups (heart~     failure with preserved vs reduced ejection fraction, de novo vs decompensated chronic heart~     failure, age ≥75 vs <75 years, women vs men and presence vs absence of concomitant pulmonary~     disease) and to compare demographics and clinical characteristics in different patient~     populations.~      300 patients, aged ≥18 years presenting to the emergency room (ER) with acute dyspnoe as~     principal complaint will undergo initial clinical assessment of the likely etiology of~     dyspnea by the ER physician in charge. The second assessment by the same physician will~     include results of NT-proBNP according to predefined cutoffs. Final diagnosis (Gold~     Standard) will be done by two experienced investigators after patient discharge taking into~     account the complete medical record except the results of lung ultrasound. Assessment of~     chest X-ray and lung ultrasound by investigators will be preforemd blinded regarding all~     other results.~   "
24695|NCT03243760|"~     This study will be the first administration of CCI15106 capsules for inhalation to humans.~     The primary objective of the study is to investigate the safety and tolerability of single~     and repeat escalating doses of CCI15106 in healthy subjects and patients with moderate~     chronic obstructive pulmonary disease (COPD). The intention of this study is to provide~     sufficient confidence in the safety of the molecule delivered by inhalation to inform~     progression to further repeat dose and proof of concept studies.~      This will be a three-part study. Part 1 will investigate single ascending doses and Part 2~     repeat ascending doses in healthy subjects. In Part 3, a single dose will be administered to~     patients with moderate COPD.~      There will be screening period of up to 30 days. The treatment period will be 3 days for~     Parts 1 and 3 and 16 days for Part 2. Follow-up will be performed within 30 days after the~     last dose.~   "
43970|NCT02991274|"~     The study primary objective is to assess the concordance of T790M resistance mutation testing~     from hospital-based laboratories with T790M resistance mutation testing from a central~     laboratory.~   "
24696|NCT03243747|"~     Preanesthetic evaluation is a clinical assessment process with purpose of increased patient~     safety. One focus is review of patient medical history to reduce perioperative morbidity and~     mortality as well as optimize the daily process in at anesthesia ambulance. The aim of that~     study is the development and implementation of a practical computer-based individualized and~     risk-adapted questionnaire for the daily routine~   "
24697|NCT03243734|"~     Prospective, open label, non-controlled single arm, multi-center study The primary objective~     is to study the effects of the trūFreeze® Spray Cryotherapy System in a population of~     subjects who have been diagnosed with persistent local esophageal cancer and who are not~     surgical candidates or have completed or declined systemic therapy.~   "
24698|NCT03243721|"~     This evaluation will be a one-year feasibility study to characterize the neuroprotective~     benefits of Gilenya and its effects on cognition and grey matter volumes. The study will~     enroll 15 patients with relapsing-remitting multiple sclerosis being treated with Gilenya and~     5 healthy controls. Each participant will undergo a battery of neurometric testing at~     baseline, six months, and one year. In addition, patients will undergo high-field 7T MRI at~     the same time points.~   "
24699|NCT03243708|"~     Venous thromboembolism (VTE) is a serious source of hospital morbidity and mortality.~     Chemoprophylaxis with heparin has been shown to reduce the occurrence of VTE, but it~     increases the risk of bleeding and it is uncomfortable to receive. For that reason, VTE~     prophylaxis should be reserved for patients at moderate to high risk of VTE and low risk of~     bleeding. However, identifying patients at low risk for VTE can be difficult, because most~     patients have at least one risk factor for VTE and there are no validated risk prediction~     tools for use in US hospitals. Instead, many hospitals have opted for a one-size-fits-all~     approach with near-universal prophylaxis, putting many patients at unnecessary risk of~     bleeding. However, to provide care that is truly patient-centered, US physicians face several~     challenges. First, there is no accepted risk calculator that they can use to estimate an~     individual patient's risk. Second, risk calculators are not readily available at the point of~     care. As a result, prophylaxis rates have remained stubbornly low in some institutions, while~     in others the rate of prophylaxis is high, but the rate of inappropriate prophylaxis is also~     high. This study uses a risk prediction tool developed at the Cleveland Clinic to assess an~     individual patient's risk of VTE. The tool is incorporated into the electronic health record~     in the form of a smart order set. In this randomized trial, we will assess the effects of the~     order set on physician behavior and patient outcomes . Examining the effectiveness of an~     electronic decision aid embedded in an EHR in routine clinical practice will test whether a~     smart order set can improve patient care by incorporating patient-specific factors into a~     complex decision process.~   "
24700|NCT03243695|"~     patients with fractured teeth in the esthetic area requiring immediate restoration will be~     recruited to the study. Immediate implants will be placed and patients will be restored~     either with straight or angled abutments. Implant failure will be measured.~   "
24701|NCT03243682|"~     compare the outcomes of SWL for renal and upper lumbar ureteric stones using the alternating~     bidirectional approach versus the standard approach.~   "
24702|NCT03243669|"~     Over the last years a number of new endoscopic imaging modalities have been introduced~     (high-definition and virtual chromoendoscopy). Given the theoretical advantage of these new~     imaging techniques, the investigators aimed to investigate their use for the detection of~     polyps during colonoscopy.~   "
24703|NCT03243656|"~     Aplastic anemia is a rare disorder characterized by pancytopenia and a hypo cellular bone~     marrow.but,It is very serious disease causing morbidity and mortality.~      Aplastic anemia can be treated effectively with haematopoietic stem cell transplantation and~     immunosuppressive drug regimens but haematopoietic stem cell transplantation has limitations~     due to its cost and many patient are unsuitable. Immunosuppressive drug has a significant~     number of patients have persistent cytopenias. Currently, the treatment of these patients is~     regular transfusion, which are expensive, inconvenient, and associated with serious side~     effects related to iron overload and transfusion.~      Eltrombopag is an oral thrombopoietin mimetic that selectively binds at the transmembrane and~     juxtamembrane domains of the thrombopoietin receptor, at sites distinct from the binding site~     of thrombopoietin therefore it does not compete for binding with the native molecule. It~     promoting thrombopoiesis and release of platelets from mature megakaryocytes. Also, promote~     other hematopoietic stem cell as well as in thrombopoiesis .~   "
24704|NCT03243643|"~     To investigate tolerability, safety, pharmacokinetics and efficacy of C-met Kinase Inhibitor~     HS-10241 single agent or combined with Apatinib in Subjects With Advanced Solid Tumours that~     are not eligible for conventional or intensive treatment. The dose of HS-10241 will be~     escalated to determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD)~     of HS-10241 single agent and in combination with Apatinib in advanced cancer patients. At the~     same time, pharmacokinetic characteristics and preliminary efficacy of HS-10241 or combined~     with Apatinb will be observed in advanced cancer patients. To determine the recommended~     dosage regimen for phase II.~   "
24705|NCT03243630|"~     To examine the acute reinforcing effects of menthol, a fruit flavor (green apple) or a fruit~     flavor plus menthol, alone or in combination with nicotine in smokers. Flavors will be~     administered by inhalation via electronic cigarettes (e-cigarettes) and nicotine will be~     administered intravenously. The reinforcing drug effects will be measured with the drug~     effects questionnaire (DEQ).~   "
24706|NCT03243617|"~     The purpose of this study is to demonstrate the safety, tolerability and efficacy of AO+ Mist~     administered daily for 4 weeks to improve the appearance of skin afflicted with keratosis~     pilaris.~   "
24707|NCT03243604|"~     Abiraterone associated with prednisone is used in prostate cancer. Abiraterone is a selective~     small-molecule inhibiting cytochrome P450 17A1 (CYP17A1), a key enzyme in androgen synthesis.~      CYP17A inhibition is also responsible for mineral corticosteroid related adverse events as~     hypokaliemia, fluid retention, and hypertension. Primary hyperaldosteronism is associated~     with cardiovascular toxicities such as atrial fibrillation and cardiac failure. Other~     androgen-deprivation therapies are not associated with increased mineral corticosteroid~     level.~      This study investigates reports of cardiovascular toxicities for treatment including L02 (sex~     hormones used in treatment of neoplastic diseases), and G03 (sex hormones) used in prostate~     cancer in the French pharmacovigilance database and in the EudraCT database.~   "
24708|NCT03243591|"~     Peri-implant mucositis is abnormal inflammation occurring around dental implants, increasing~     the risk of loss of bone support. The purpose of this study is to evaluate the impact of~     brushing the bacterial biofilm at the implant-mucosa interface with one of two,~     commercially-available dental gels over a 30-day period on amounts of biofilm and indices of~     mucosal inflammation. Adult subjects (> 19 years old) will be invited to consent if they have~     at least one dental implant displaying mucositis defined as Gingivitis Index of 2 or greater,~     no dental treatment in the previous 30 days, capable of normal toothbrushing, and no Sjogrens~     disease, immunodeficiency, pregnancy, poorly-controlled diabetes, or regular systemic~     antibiotics, anti-inflammatory drugs or immune suppressants. Ten patients in each tooth gel~     group will be instructed to apply a pea size amount of dentifrice brushing the implant and~     mucosa 2 times daily for 30 days. Baseline and 30-day examinations will be conducted to~     record Gingivitis Index, Plaque Index, probing depths, clinical photo, crevicular fluid, and~     adverse events.~   "
24709|NCT03243578|"~     The aim of the current study was to clarify the relationship between protein intake and~     health by using a very large, general population cohort study, UK Biobank, to study the~     associations between reported protein intake (expressed in g/day, g/kg/day and % of total~     energy intake) and three health outcomes (all-cause mortality, incidence CVD and cancer).~   "
24710|NCT03243565|"~     Clinical research question: Can OM-85 reduce the recurrence of respiratory tract infections~     (RTIs) in children with AH by stimulating the immunological response of the host and~     therefore, as a consequence reduce the size of adenoid tissue in children with adenoid~     hypertrophy? Can this prevent further complications such as surgery need? Half of~     participants will receive OM-85, while other half will receive a placebo.~   "
24711|NCT03243552|"~     This project will use the experimental medicine approach of a Phase IIa Proof of Mechanism~     16-week, randomized, double-blind, controlled trial of L-DOPA versus placebo administration~     in combination with a 16 week social skills training group in order to: 1) identify~     differences in social reward processes in adolescent and young adult ASD participants versus~     healthy controls as measured by fMRI activation in reward circuitry; 2) provide evidence of~     dopaminergic moderating effects on social reward components in ASD with greater pre- to~     post-treatment changes expected in the subjects randomized to L-DOPA versus placebo; 3)~     examine the hypothesis that baseline readouts of putative dopamine signaling (wanting~     activation responses) will predict the extent of fMRI reward-related activation changes pre-~     to post-treatment; and, 4) examine the proposed relationship between pre- to post- L-DOPA~     fMRI reward changes and changes in individual self-report ratings of social wanting and~     ratings of videotaped positive affect in a structured interaction with an examiner. The study~     will enroll 56 participants with DSM-5 ASD between the ages of 13-30 years of age and 18~     healthy control participants without histories of psychopathology for baseline comparisons.~   "
24712|NCT03243539|"~     Patients who experience lung injury are often placed on a ventilator to help them heal;~     however, if the ventilator volume settings are too high, it can cause additional lung injury.~     It is proven that using lower ventilator volume settings improves outcomes. In patients with~     acute brain injury, it is proven that maintaining a normal partial pressure of carbon dioxide~     in the arterial blood improves outcomes. Mechanical ventilator settings with higher volumes~     and higher breathing rates are sometimes required to maintain a normal partial pressure of~     carbon dioxide. These 2 goals of mechanical ventilation, using lower volumes to prevent~     additional lung injury but maintaining a normal partial pressure of carbon dioxide, are both~     important for patients with acute brain injury. The investigators have designed a~     computerized ventilator protocol in iCentra that matches the current standard of care for~     mechanical ventilation of patients with acute brain injury by targeting a normal partial~     pressure of carbon dioxide with the lowest ventilator volume required.~      This is a quality improvement study with the purpose of observing and measuring the effects~     of implementation of a standard of care mechanical ventilation protocol for patients with~     acute brain injury in the iCentra electronic medical record system at Intermountain Medical~     Center. We hypothesize that implementation of a standardized neuro lung protective~     ventilation protocol will be feasible, will achieve a target normal partial pressure of~     carbon dioxide, will decrease tidal volumes toward the target 6 mL/kg predicted body weight,~     and will improve outcomes.~   "
24713|NCT03243526|"~     the aim in this study to assess the effect of fluid management in patient undergoing~     orthotopic liver transplantation either by using pulse pressure variation or by central~     venous pressure. we will assess the impact of fluid management by either methods on~     oxygenation and extra vascular lung water visualized by lung ultrasound.~   "
24714|NCT03243513|"~     The aim of the project is to identify an efficient and effective policy or procedure for~     identifying complications from surgical abortions through follow-up phone calls.~   "
24715|NCT03243500|"~     There are several local anesthetic techniques available for cataract surgery and the choice~     depends on patient, surgical and operator factors. The eyes of patients with axial myopia~     (the eye globe is abnormally elongated) have thin wall (sclera), limited space for needle~     insertion for local anesthetic injection between the globe and the orbit and out-pouching of~     the back of the eye (staphyloma). These factors increased the risk of perforation following~     conventional needle techniques of eye block The current study technique is per-caruncular~     injection (the needle insertion site is between the nasal side of the globe and bony orbit)~     which may provide a safer alternative to the conventional needle techniques for myopic~     patients. The space of injection is devoid of blood vessels moreover, myopic staphylomata are~     infrequently located on the nasal side of the globe.~      Local injection of muscle relaxant added to local anesthetic solution may provide earlier~     onset of eye muscle paralysis thus earlier onset of favorable surgical condition than local~     anesthetic solution alone.~      The current study will demonstrate the effect of adding low dose atracurium (a muscle~     relaxant) to local anesthetic mixture in providing early onset of eye muscle paralysis and~     favorable surgical condition in per-caruncular technique of eye block in high myopes~     undergoing cataract surgery.~   "
24803|NCT03242356|"~     Current French guidelines allow oral intake of clear fluid in women in established labor~     under epidural analgesia. To date, no study assessed how these guidelines are followed in~     clinical practice. This study aims to assess the current practices as to the fasting during~     the labor at our institution, while assessing the experience and the expectations of the~     parturients (level of comfort or discomfort related to fasting).~   "
24716|NCT03243487|"~     The study is a prospective, randomized, controlled trial studying adherence to positive~     airway pressure therapy in a population referred to the VA system for the treatment of sleep~     disordered breathing. The primary aim of the study is to determine if, compared to standard~     care provided at a VA Sleep Center, the deployment of a structured adherence management~     program and a web-based information program designed for participants beginning positive~     airway pressure therapy results in a greater portion of participants meeting Centers for~     Medicare & Medicaid Services (CMS) adherence requirements (use > 4 hours for >= 70% of days)~     at 90 days.~   "
24717|NCT03243474|"~     The aim of this project is to recognize the actual frequency of atrial fibrillation in the~     Polish population as well as to determine the independent risk factors for the occurrence of~     its clinically symptomatic and asymptomatic forms~   "
24718|NCT03243461|"~     The HIT-HGG-2013 trial offers an innovative high-quality diagnostics and science program for~     children and adolescents >3 years, suffering from one of the following types of high grade~     gliomas:~        1. glioblastoma WHO grade IV (GBM)~        2. diffuse midlineglioma histone 3 K27M mutated WHO grade IV (DMG)~        3. anaplastic astrocytoma WHO grade III (AA)~        4. diffuse intrinsic pontine glioma (DIPG)~        5. gliomatosis cerebri (GC) For 1.-3. diagnosis has to be confirmed by neuropathological~          survey, for 4. and 5. diagnosis has to be confirmed by neuroradiological survey.~      In addition to standard treatment (radiotherapy and temozolomide chemotherapy) the effects of~     two further drugs, which have been applied to millions of children and adolescents in other~     indications, will be compared to each other. The aim of the trial will be to investigate~     whether these drugs may increase the effects of radio- and chemotherapy, resulting in a~     better survival of the treated patients. One of these additional drugs will be valproic acid,~     traditionally used for treatment of seizure disorder. The other drug will be Chloroquin, a~     well-established drug for Malaria treatment. Recently, scientific studies provided evidence~     for anti-tumoral effects of both drugs: Valproat seems to be a so-called histondeacetylase~     inhibitor (HDAC inhibitor), controlling important genetic processes of tumor growth.~     Chloroquin is an autophagy inhibitor. It prevents the shutting-down of tumor cell metabolism,~     a strategy to ensure survival of the whole tumor by developing a resistance against radiation~     and antineoplastic agents.~      Studies in cell culture, animals and first clinical trials in adults as well provided~     evidence for efficacy of valproic acid and chloroquine in the treatment of glioblastoma. Due~     to this we hope children and adolescents suffering from GBM, DMG, AA, DIPG und GC will~     benefit from the treatment, too. As common for clinical trials, the treatment of the patients~     will be settled in a randomized manner to ensure impartiality of the investigators.~      One aim of the HIT-HGG-2013 trial will be to compare the effects of Valproat and Chloroquin~     to each other. Additionally, the results will be compared with data of the HIT-HGG-2007 trial~     (children and adolescents with same diseases, only treated with simultaneous temozolomide~     radiochemotherapy).~   "
24719|NCT03243448|"~     There are many sympathetic hyperactivity diseases in the investigators' clinical practice.~     However, the conventional method to measure the sympathetic nerve activity had many~     limitations such as clinical application, data interpretation and even therapeutic~     manipulation. Therefore the investigators would like to develop a non-invasive method to~     record the sympathetic nerve activity in the investigators' study that can help gathering the~     sympathetic nerve activity easily in the investigators' daily clinical situation. By the~     determination of sympathetic nerve activity status, the health caregiver can understand the~     disease more.~   "
24720|NCT03243435|"~     In a previous study in 2012/2013 patients were injected a superparamagnetic iron oxide for~     sentinel lymph node detection. In this follow up study we want to investigate how much of~     this tracer is still detectable.~   "
24721|NCT03243422|"~     The ACHIEVE study will be a randomized controlled trial nested within the Atherosclerosis~     Risk in Communities (ARIC) study. 850 70-84 year-old cognitively normal older adults with~     hearing loss will be randomized 1:1 to the hearing intervention (hearing needs assessment,~     fitting of hearing devices, education/counseling) or successful aging intervention~     (individual sessions with a health educator covering healthy aging topics). Post baseline,~     participants will be followed semi-annually for 3 years.~   "
24722|NCT03243409|"~     Retrospective observational study of reversed shoulder arthroplasties by proximal humeral~     fracture. Analysis of preoperative risk factors as well as minor and major complications at~     the first week, 90 days and 1 year.~   "
24723|NCT03243396|"~     The study will take place in Kanduyi, a sub-county in southern Kenya, and focuses on children~     orphaned by one or two parents. Growing evidence demonstrates that orphaned children in low-~     and middle-income countries are at high risk of post-traumatic stress, but mental health~     professionals are largely unavailable in this area.~      Research suggests that some mental health treatments can be delivered effectively in low- and~     middle-income countries using a task sharing approach, in which lay counselors with little or~     no prior mental health experience are trained to provide treatment.~      Whetten and Dorsey's past studies have suggested that partnering with two government sectors,~     education and health, could be a low-cost and sustainable strategy to implement task sharing~     mental health services. By training teachers (via the education sector) and community health~     volunteers (via the health sector) to provide mental health care, a larger population could~     potentially be reached.~      Before programs are scaled-up country-wide, it's important to know not only what policies to~     implement but also their predicted implementation success and intervention effectiveness.~     This study aims to identify implementation strategies and examine whether the education~     and/or health sectors are productive partners in scaling up task sharing mental health care~     in future programs.~   "
24724|NCT03243383|"~     Post-discharge hospital utilization, i.e., readmissions within 30 days of discharge (30d~     readmissions) and emergency department (ED) visits, are a high-priority quality measure and~     target for cost reduction. Patients with diabetes are disproportionately over-represented in~     30d readmissions, especially among racial minorities and urban populations. We have developed~     and validated a tool, the Diabetes Early Readmission Risk Indicator (DERRI), to predict 30d~     readmission risk among diabetes patients, which is a critical prerequisite for targeting~     limited resources for reducing readmission risk to those most in need. Currently, there are~     no proven interventions to reduce the risk of 30d readmission specifically among patients~     with diabetes. This proposal will assess the feasibility and acceptability of a novel,~     multifactorial intervention, the Diabetes Transition of Hospital Care Program (DiaTOHC),~     designed to reduce post-discharge hospital utilization rates in a pilot randomized controlled~     trial. The intervention will include inpatient diabetes and discharge education,~     comprehensive discharge planning and coordination of care, A1c-based adjustment of diabetes~     therapy, and post-discharge support. Hospitalized patients with diabetes identified as high~     risk for readmission based on the DERRI will be randomized to the intervention or the control~     group, which will receive usual care. Such work is highly relevant in the current era of~     soaring health care costs and national health care reform.~   "
27302|NCT03209635|"~     A The aim of this study was to investigate the impact of consuming Weissella cibaria (W.~     cibaria) JW15 supplementation isolated from Kimchi, Korea traditional fermented food, on~     natural killer (NK) cell activity and circulating levels of cytokines and immunoglobulin~     (Ig).~   "
24725|NCT03243370|"~     This study concerns the validation of a clinical test that aims to reveal first level~     emotional disorders in neurological diseases.~      In order to bring to light such disorders, it is necessary to begin by establishing reference~     values in healthy individuals. This test is based on the priming effect and time estimations.~     The test procedure has two successive phases. The first phase aims to determine the judgement~     of time inherent to each participant and then to assess whether or not this judgement varies~     during the second phase with the introduction of emotional priming. First, we set out to look~     for and to calibrate video stimuli able to activate emotions. To this end, we used a battery~     of 70 sequences developed recently by Schaefer, Nils, Sanchez and Philippot. We determined~     their degree of physiological activation by measuring the electrodermal response at the~     laboratory for the exploration of the nervous system in Dijon. These measurements also~     allowed us to define and refine our paradigm, notably by deciding at what moment the time~     estimation task should be done and by eliminating the influence of attention. We decided to~     select only seven video sequences because we noticed a reduction in the measurement effect on~     time estimations due to habituation of the subject. We also conducted pre-tests in a control~     population made up of twenty men and women aged from 20 to 60 years.~      This brought to light a warp in time estimation opposite to that we found using olfactory~     stimuli. This first finding suggests that there are two types of emotion, one which is~     anticipative and the other immediately experienced.~   "
24726|NCT03243357|"~     In view of the wide variety of mechanized endodontic instrumentation systems, the ideal would~     be that the choose of this system based on the anatomical characteristics of the canal and~     the biological precepts. In teeth with lesions, contaminated dentin should be removed.~     However, in many systems, the manufacturer's approach disregards the fact that in wider root~     canal, instruments used in the apical third small diameter (less than 0.40 mm) may not touch~     the walls at the final apical. Therefore, the establishment of the initial apical file (LAI),~     the first instrument that measures the resistance of the walls in working length, could be a~     criterion in the choice of which system to use, and how many files work within the root~     canals after LAI determination. However, there is a lack of studies that demonstrate that LAI~     determination affects the degree of cleaning achieved, as well as the impact that LAI-based~     instrumentation may have on microcracks formation, canal transportation, postoperative pain~     and quality of obturation.In this way, the investigators propose a study in vivo performed,~     in patients from 8 to 18 years of age, therefore in large root canals. The protocol~     recommended by the manufacturer will be compared by means of a prospective randomized~     clinical trial, with the addition of the XP Endo finisher and with the protocol based on the~     initial apical file evaluating postoperative pain, exacerbation between the sessions, the~     quality of the obturation and periapical radiolucency repair. Considering that currently~     performing endodontic treatments using mechanized instruments is taught in undergraduate~     courses throughout the country, studies of this nature help the execution of a endodontics~     more critical and effective.~   "
24727|NCT03243344|"~     This study evaluates the efficiency and the cost of three medical devices and the abstention~     of the use of specific product for the post-operative haemostasis in endonasal surgery .~   "
24728|NCT03243331|"~     Phase 1 study to evaluate the safety and effect of Gedatolisib and PTK7-ADC for the treatment~     of triple negative breast cancer~   "
24729|NCT03243318|"~     Stroke is the third common cause of adult disability in dveloped countries. Early~     identification of the potential for motor recovery is important to avoid 'learned disuse' and~     to initiate appropriate therapy with achievable goals. The current cohort study focuses on~     those patients with SAFE <8 and using motor evoked potentials (MEPs) to improve on~     prognostication of upper limb motor recovery among subacute stroke patients in a local stroke~     population.~   "
24730|NCT03243305|"~     This is a single-arm, open-label, Phase III study in approximately 100 sites in the United~     States (US) over seven cycles of use in women aged 18 to 35 years who are at risk of~     pregnancy.~   "
24731|NCT03243292|"~     To confirm the long-term efficacy and safety of Bronchial Thermoplasty (BT) at 10 years~     follow-up or beyond in subjects previously enrolled in any of the following Boston~     Scientific-sponsored, controlled pre-approval studies: AIR, RISA and AIR2.~   "
24732|NCT03243279|"~     The purpose of this study is to determine whether baroreceptor sensitivity (the ability of~     your body to change your heart rate and/or blood pressure in response to a situation) has any~     effect on how likely you are to suffer certain events after heart or lung surgery. The~     postoperative events that the investigators will be studying are pain after surgery, atrial~     fibrillation (an irregular heart rhythm), and cognitive dysfunction (a decline in mental~     abilities).~   "
24733|NCT03243266|"~     Results from this study will be used to verify that the published pediatric reference~     intervals are met on the DxH 520 Hematology Analyzer for the pediatric age ranges.~   "
24734|NCT03243253|"~     In this cross sectional study, county level data for CVD and stroke mortality, and prevalence~     of T2D, were combined with per capita densities of FFR and FSR and analysed using multiple~     and simple linear regression. Mortality and diabetes prevalence were corrected for poverty,~     ethnicity, education, physical inactivity and smoking to reduce confounding effects.~   "
24742|NCT03243149|"~     PTSD is a debilitating and costly condition and currently available treatment options have~     risks and limitations that necessitate development of novel interventions. Collectively, the~     functional brain imaging reports suggest that patients with PTSD, especially those with the~     re-experiencing and hypervigilence phenotype, show ventromedial PFC hypoactivation and~     amygdala hyperactivation in response to symptom provocation, and that treatment, when~     successful is associated with reduced amygdala and increased ventromedial PFC activation.~     This project is guided by a neurocircuit model of PTSD dysfunction in which abnormalities in~     fronto-limbic imbalance, which diminishes capacity for fear extinction learning, and produces~     PTSD symptoms of re-experiencing and hyperarousal. Thus, our studies aim to bridge the~     translational gap between theoretical and neurobiological models of PTSD to implementation of~     clinical practice. The Target Engagement and Dosing Phase of this project, which is a pilot~     study, will demonstrate target engagement and its association with laboratory measures of~     PTSD-relevant neural processes.~   "
28670|NCT03191721|"~     The aim of this study was to evaluate the effects of a dentifrice containing 0.3% triclosan~     on periodontal and peri-implant parameters in patients, with or without periodontitis,~     treated for peri-implantitis and that were enrolled in a maintenance phase for two years.~   "
24735|NCT03243240|"~     Gastrointestinal bleeding represents a serious clinical problem and a common cause of~     hospitalisation with a mortality rate of 6-10% for upper Gastrointestinal bleeding and of 4%~     for lower Gastrointestinal bleeding requires a multidisciplinary approach involving~     gastroenterologists, endoscopists, surgeons and radiologists.~      Gastrointestinal bleeding is self-limited in 80% of cases requiring only supportive measures.~     However, the persistence of bleeding represents a diagnostic challenge to locate the site of~     bleeding especially in severe bleeding and to determine, if possible its cause. This will~     allow to select the most appropriate therapeutic approach in order to reduce the morbidity~     and mortality, the length of hospitalisation and the transfusion requirements.~      Current diagnostic algorithms vary widely from institution to institution and from clinician~     to clinician. Imaging modalities remain the mainstay of the diagnostic approach. They include~     endoscopy, video capsule, radionuclide imaging, catheter angiography and multidetector~     computed tomography imaging.~      In recent years, Multidetector computed tomography has emerged as a promising technology to~     evaluate Gastrointestinal bleeding. The modality's ease of use and rapid results favour its~     use in any emergent situation. In addition, today's high-speed, narrow collimation~     multi-detector technology allows a large coverage area with minimal motion artifacts, with~     the ability to capture both arterial and venous phase with ease. Multidetector computed~     tomography is being increasingly used as this is a widely available, non-invasive and fast~     diagnostic technique that allows for visualisation of the entire intestinal tract and its~     lesions, the identification of vascularity and possible vascular abnormalities.~   "
24736|NCT03243227|"~     Carpal tunnel syndrome CTS is the most common peripheral neuropathy seen in clinic. It~     results in marked functional limitations of patients. Most patients undergo surgical release~     which places a heavy burden on health system. Neurodynamic exercise is claimed to be an~     effective physiotherapy treatment for these patients. It is a practical and~     complications-free treatment which can be used as a home exercise program. This study aims to~     investigate the effect of median nerve gliding exercise on symptoms severity and functional~     limitation in CTS patients.~   "
24737|NCT03243214|"~     Parkinson's disease (PD) affects more than 100,000 Canadians and results in symptoms~     affecting both motor and cognitive (thinking and memory) functions. Parkinson's disease with~     Mild Cognitive Impairment (MCI) frequently results in development of dementia for which few~     treatment options exist. Transcranial Magnetic Stimulation (TMS) is used to alter activity in~     the outer regions of the brain and has been shown in previous studies to increase cognitive~     performance in patients with different disorders. This study will investigate the~     effectiveness of TMS as a clinical treatment for the cognitive deficits associated with~     Parkinson's disease. 64 male and female participants between the ages of 50 and 90 will~     attend eight study visits over a period of 63 to 66 days. This study is a double-blind~     randomized clinical trial meaning the participant will be assigned by chance to either the~     TMS-treatment group or the Sham-treatment group. Additionally, a combination of memory and~     thinking tests and Magnetic Resonance Imaging (MRI) will be used to see if there are~     structural and functional changes within the brain. Genotyping and blood analysis before and~     after treatment for different biomarkers will also be performed and these data will be~     compared to the TMS data. Initially, this research will increase knowledge about the effects~     of TMS on various brain regions. Ultimately, we will be able to determine if TMS can be used~     as a complementary therapy for PD to improve cognitive performance and to reduce progression~     into dementia.~   "
24738|NCT03243201|"~     Chronic rhinosinusitis is a highly prevalent disease resulting in high economic burden.~     Effective therapeutic options are needed. Rhinosinusitis-related biofilms are a likely~     contributor to recalcitrant disease. Emerging evidence shows that colloidal silver~     nanoparticles may be effective for reducing biofilms. The investigators intend to perform a~     randomized, double-blinded, placebo-controlled clinical trial to evaluate the effectiveness~     and safety of intranasal colloidal silver nanoparticles in adult patients with chronic~     rhinosinusitis. The investigators hypothesize that compared to placebo, treatment with~     intranasal colloidal silver for chronic rhinosinusitis will lead to a significant improvement~     in symptom scores and will not be associated with increased rate of adverse effects.~   "
24739|NCT03243188|"~     Study Title: Palliative care in general practice: cancer patients' and carers' experience of~     their GP's role~      Study Design: Qualitative interview study~      Study Participants: Adult patients with cancer and palliative care needs, accompanied by~     their carers~      Planned Sample Size: Up to 30 interviews with patients +/- their carers~      Planned Study Period: October 2017 - December 2018~      Research Question: What experience do adults with cancer, and carers, have of their GP's~     involvement in palliative care provision?~   "
24740|NCT03243175|"~     Randomised controlled trials (RCTs) demonstrate a substantial benefit from oral anticoagulant~     drugs for the prevention of stroke and systemic embolism in non-valvular atrial fibrillation~     (AF). However, these RCTs excluded patients with prior intracerebral haemorrhage (ICH).~     Therefore, guidelines are unable to recommend whether oral anticoagulant drugs, in particular~     non-vitamin K antagonist (called direct OAC) - can be used for patients with AF after an~     intracerebral haemorrhage.~      Roughly 30% of adults with ICH have AF but in 2017 it remains unclear whether they should~     start oral anticoagulant drugs, be treated with left atrial appendage closure (LAAC) or avoid~     anticoagulation and LAAC.~   "
24741|NCT03243162|"~     The overall objective of this study is to conduct a two-group randomized trial to examine the~     efficacy of cognitive-behavioral based physical therapy (CBPT) for improving knee function,~     return to sport, and quality of life outcomes in patients following ACL reconstruction~     (ACLR). The study consists of two treatment groups: telephone-based cognitive-behavioral~     based physical therapy for ACLR (CBPT-ACLR) and telephone-based Education. The central~     hypothesis is that the CBPT-ACLR participants relative to the Education group will~     demonstrate significantly greater improvement in postoperative outcomes at 12 months~     following surgery.~   "
24753|NCT03243006|"~     introduction: Pain remains one of the most common reasons of emergency department admission.~     Opioids are overprescribed in emergency departments to treat severe pain.~      objective: assessing the impact of ealy pain pain management on the use of intravenous~     morphine and on patient satisfaction.~   "
24870|NCT03241472|"~     Infertility is defined as a couple's inability to become pregnant after one year of~     unprotected intercourse in women 35 years old and younger, and for six months in women over~     age 35 years. In any given year, about 15 percent of couples in North America and Europe who~     are trying to conceive are infertile~   "
24743|NCT03243136|"~     A pervasive and persistent finding is the health disadvantage experienced by those in food~     insecure households. While clear associations have been identified between food insecurity~     and diabetes risk factors, less is known about the relationship between food insecurity and~     incident type 2 diabetes.~      The objective of this study is to investigate the association between household food~     insecurity and the future development of type 2 diabetes.~      The investigators used data from Ontario adult respondents to the 2004 Canadian Community~     Health Survey, linked to health administrative data (n = 4,739). Food insecurity was assessed~     with the Household Food Security Survey Module and incident type 2 diabetes cases were~     identified by the Ontario Diabetes Database. Multivariable adjusted Cox proportional hazards~     models were used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs) for type~     2 diabetes as a function of food insecurity.~   "
24744|NCT03243123|"~     This is a single arm study aimed at evaluating the acute effects induced by a single session~     of robot-assisted passive hand mobilization on local perfusion and upper limb function in~     post-stroke hemiparetic patients. Twenty-three participants with subacute or chronic stroke~     received 20 min passive mobilization of the paretic hand with robotic assistance. After the~     intervention, significant improvements were found in forearm perfusion, muscle tone~     significantly decreased and subjects reported decreased upper limb heaviness, stiffness and~     pain. This study supports novel evidence that hand robotic assistance promotes local forearm~     circulation, may help in the management of spasticity and acutely alleviates reported~     symptoms of heaviness, stiffness and pain in subjects with post-stroke hemiparesis.~   "
24745|NCT03243110|"~     The study will consist of three phases: Phase A: General population survey for estimation of~     the prevalence of asthma, and prospective collection of resource utilization and~     quality-of-life data for 12 months, Phase B: comparison of healthcare resource usage~     collected prospectively to the data collected using administrative data in the population~     recruited in Phase A, and Phase C: Economic modeling of asthma to extrapolate the findings~     across Canada and into the future years.~   "
24746|NCT03243097|"~     Bilateral profound sensorineural hearing loss (PSNHL) is often treated with Cochlear~     Implants. The majority of bilaterally deafened patients, however, often only receive a~     unilateral cochlear implant (CI), with resultant limitations related to monaural listening.~     For unilateral CI users, the deficits inherently associated with monaural listening remain~     despite the considerable benefits achieved through implantation. Providing bilateral input to~     monaural listeners (MLs) overcomes some of these disadvantages. Treatment by contralateral~     routing of signal (CROS) hearing aids, where the signal of interest is routed from the~     impaired (deaf) ear to the normal cochlea for processing is a promising alternative in~     unilateral CI recipients who cannot benefit from bilateral CIs. Utilizing CROS technology~     provides a less invasive alternative for patients who are unable or unwilling to undergo a~     second CI surgery and offers an innovative approach to resolving the auditory deficits~     associated with monaural listening. CROS technology has been used to treat traditional~     monaural listeners since 1965. When applied to unilateral CI users, this novel approach can~     overcome a key limitation of current treatment by restoring access to sound from the~     non-implanted ear and improving speech perception in noise.~   "
24747|NCT03243084|"~     Chronic pain is a severe disabling problem within society, affecting 25-30% of the United~     States population.. Transcranial alternating current stimulation (tACS) has the potential to~     provide a treatment option that is safe, scientifically-supported, low-cost, and~     easy-to-administer method to effectively reduce symptoms in patients suffering from chronic~     pain. The purpose of this study is to test the feasibility of using tACS to treat patients~     with chronic pain, and to collect pilot efficacy as well as EEG and EKG biomarker data for~     optimizing the design of subsequent large-scale studies. The treatment rationale is to~     renormalize the presumed pathological structure of alpha oscillations in the prefrontal~     cortex (PFC) of patients with chronic pain.~   "
24748|NCT03243071|"~     The purpose pf this study is to evaluate the comparative effectiveness of a culturally and~     linguistically tailored clinical trial literacy website in increasing likelihood of~     participating in clinical trials. To achieve this objective,a randomized group design will~     address the following patient-centered outcomes: willingness to enroll in clinical trials and~     behavioral intent as well as likelihood of referring others to enroll in such trials) before~     and after exposure to a culturally-tailored clinical trial literacy website. Health literacy~     will be measured both before and post exposure to tailored messages. Participants will be~     randomized into two groups. The intervention group (n=50) will have access to culturally~     tailored website. Participants in the control group (n=50) will have access to NYU 's~     standard trial participation website.~   "
24749|NCT03243058|"~     Randomized, controlled, double blinded, multicenter, phase I/II clinical trial to evaluate~     the safety of low-dose IL-2 and to test whether low-dose IL-2 can prevent further loss of~     beta-cell function in patients with established T1D, or even potentially improve ß-cell~     function in such individuals, when IL-2 is given for one year (primary outcome). Equally~     important, the study will carefully examine various effects of low-dose IL-2 on the immune~     system in patients with T1D, including effects on Treg and other cell subsets, and~     disease-specific autoimmune responses.~   "
24750|NCT03243045|"~     It has been proposed that the modulation of the activity of the sympathetic nervous system,~     through renal sympathetic denervation, besides reducing blood pressure, would promote an~     improvement in vascular reactivity and consequent improvement of macro and microcirculation.~      The present study aimed to investigate the influence of the renal sympathetic denervation on~     the skin microvascular function of patients presenting with resistant arterial hypertension.~   "
24751|NCT03243032|"~     To determine the clinical effectiveness of combined use of pre-emptive analgesia and long~     acting anesthesia for pain suppression following dental implant surgery as measured by a~     validated numerical rating scale and the information related to consumption of post-operative~     medications.~   "
24752|NCT03243019|"~     To evaluate the efficacy of Rapamycin in extended cervicofacial lymphatic malformations in~     pediatric patients. Rapamycin is administered oral for a 6 month period.~      The success rate is determined by volume reduction superior to 1/5e of the initial volume~     measured by MRI, impact on QOL and reduction of bleeding in case of mucosal involvement.~   "
24871|NCT03241459|"~     To demonstrate the safety and efficacy of the SurVeil Drug-Coated Balloon (DCB) for treatment~     of subjects with symptomatic peripheral artery disease (PAD) due to stenosis of the femoral~     and/or popliteal arteries.~   "
24754|NCT03242993|"~     This is a clinical trial category C as this is a first in man trial with an unapproved~     investigational product. Nevertheless the risk is considered low due to the low dose ≤ 10μg.~     No toxicity effects were observed preclinically at a dose >1000 -fold the intended dose.~     Open-labeled, non-blinded, non-placebo controlled, multicenter study.~      Primary objective:~      Assessment of biodistribution and FR-specific tumor detection of [18F]- AzaFol as a PET~     imaging agent in patients with FR-positive and FR-negative metastatic cancer of the ovaries~     or lungs.~      Secondary objective:~      Calculation of the effective dose to the patient according to the tissue distribution data of~     [18F]-AzaFol (Dosimetry)~   "
24755|NCT03242980|"~     In the era of test-and-treat, with anticipated high numbers of patients who will have~     unsuppressed viral load (VL) due to poor adherence, simple, short and standardized adherence~     interventions with documented efficacy will be needed. Achieving re-suppression in patients~     with unsuppressed VL is beneficial for the health of the individual, important to reduce the~     risk of transmission and has a direct cost implication because patients with sustained~     unsuppressed VL will ultimately be switched to more expensive 2nd-line regimens.~      Information is still largely lacking on how to best address adherence problems among patients~     with unsuppressed VL. VL monitoring is recognized as a useful tool to reinforce adherence in~     patients with unsuppressed VL. The Lesotho Guidelines recommend redoing a VL 8-12 weeks after~     the first enhanced adherence counselling. To date no study has been published clearly~     demonstrating higher re-suppression rates after enhanced adherence counselling for patients~     with unsuppressed VL.~      This project aims to test an adherence intervention for HIV-positive individuals on~     first-line ART who have an unsuppressed viral load. A step wedged study will be used to~     compare the effectiveness of a short, standardized adherence counselling followed by an SMS~     reminder to the standard of care (≥ 2 unstructured adherence counselling sessions) in terms~     of viral re-suppression rates and switches to 2nd line ART.~   "
24756|NCT03242967|"~     This is a Phase 3 Study to Evaluate Three Times Per Week (TIW) Oral Dosing of Vadadustat for~     Anemia in Subjects with Dialysis-Dependent Chronic Kidney Disease (DD-CKD)~   "
24757|NCT03242954|"~     The purpose of this study is to examine how the consent process affects the acceptability of~     participation in biomedical HIV prevention trials, from the perspective of behaviorally~     high-risk minors and the parents of minor adolescents.~   "
24758|NCT03242941|"~     The purpose of this non-randomized, non-controlled, acute, single-arm research study is to~     evaluate the feasibility to obtain a stable position of a ring of stimulation electrodes on~     the interatrial septum. The possibility to terminate atrial arrythmias will also be~     evaluated.~   "
24759|NCT03242928|"~     This will assess whether AFQ056 can have a beneficial effect by reducing cocaine use in~     Cocaine Use Disorder (CUD) patients as assessed by Timeline Follow-Back cocaine self-report.~   "
24760|NCT03242915|"~     Investigators hypothesize that addition of pembrolizumab will enhance the efficacy of~     carboplatin and pemetrexed in EGFR (epidermal growth factor receptor) mutation and ALK~     (anaplastic lymphoma kinase) positive NSCLC patients who have disease progression following~     prior TKIs (tyrosine kinase inhibitors).~   "
24761|NCT03242902|"~     Cancer related fatigue (CRF) is one of the most prevalent and distressing long-term~     complaints reported by (non-) Hodgkin survivors. The SPARKLE study will test the efficacy of~     two intensities of light therapy on cancer related fatigue. Additionally, it explores~     possible working mechanisms of light therapy on CRF including improvements in sleep quality,~     psychosocial variables (depression, anxiety, cognitive complaints, and quality of life), and~     changes in biological circadian rhythms.~   "
24762|NCT03242889|"~     The purpose of this study is to evaluate the tolerability and safety of subcutaneous (SC)~     delivery of co-formulated daratumumab and rHuPH20 preparation (DARA SC) in Japanese~     participants with relapsed or refractory multiple myeloma (MM).~   "
24763|NCT03242876|"~     Research has shown that diets that give rise to a high glucose response are associated with a~     number of abnormalities like increased risk of metabolic syndrome. Metabolic syndrome mostly~     comprises of insulin resistance and glucose intolerance which gives an increased risk of type~     2 diabetes. It also gives rise to other conditions like high blood pressure (arterial~     hypertension), elevated blood insulin levels (hyper-insulinemia), elevated amounts of fat in~     the liver (fatty hepatosis) and elevated amounts of lipids in the blood (dyslipidemia). After~     type 2 diabetes become clinically apparent, the risk of cardiovascular disease also rises.~     Research has also shown that foods/drinks which raise blood glucose levels gradually (low GI)~     rather than rapidly (high GI) have health benefits which include reducing the risk of~     metabolic syndrome. Laboratory studies have shown that polyphenols found in fruits,~     vegetables and plant based foods have a positive effect on carbohydrate metabolism and can~     lower the blood glucose levels.~      Therefore a lower glycemic index diet may have benefits in terms of type two diabetes and~     heart disease management, and as a method for weight loss. There has been some research into~     the effects of pomegranate on lowering blood glucose responses both chronically and acutely.~     Mechanistic evidence suggests that this effect could be down to the organic acids found~     within pomegranate juice. 16 volunteers were fed 50 g available carbohydrate from white bread~     (109 g), and either 200 ml water (control) or 200 ml solution (test) containing citric acid~     (3.8 g) and malic acid (119 mg) the quantities that are found in 200 ml pomegranate juice~     (Biona) as analysed. Blood glucose was measured at baseline, and at 30 - 60 minute increments~     over three hours. Glucose curves were plotted, and the area under the curve was calculated~     and compared between conditions for each participant.~   "
24764|NCT03242863|"~     In this study, the investigators will vary the proportions of high- and low-energy-dense~     foods served to preschool children at all meals and snacks during three 5-day periods. In the~     three experimental conditions, the same foods will be served; only the amounts and~     proportions of foods will be varied. In the Baseline condition, typical proportions of~     age-appropriate foods will be served. In the Addition condition, the portion sizes of~     low-energy-dense foods will be increased, and in the Substitution condition, the portions of~     low-energy-dense foods will be increased by replacing an equivalent amount of foods higher in~     energy density. The primary aim is to determine the effect on children's energy intake of~     varying the proportion of low- and high-energy-dense foods served, either by addition or~     substitution, over 5 days. It is hypothesized that children will consume less energy when~     they are served meals in which low-energy-dense foods are substituted for foods higher in~     energy density over 5 days and that children will consume more energy when served meals to~     which low-energy-dense foods are added. Additionally, we will test the hypothesis that daily~     energy intake in the three conditions will begin to converge across the 5-day period.~   "
24765|NCT03242850|"~     This study tests whether an enhanced primary cared based literacy promotion intervention~     consisting of a video and text message will increase shared reading occurrences between~     parents and children compared to the standard version.~   "
24768|NCT03242811|"~     It is important that asylum seekers should have as accurate age assessment as possible and~     that children's fundamental rights are met by choosing methods based on best available~     knowledge. The aim is to provide, on the basis of best available knowledge, suggestions for~     methods of medical age assessment of whether a person is over or under 18 years of age.~      The primary issue is to investigate whether five selected growth zones in knee joint, ankle~     and wrist individually or in combination can better determine the 18-year limit compared with~     previous research.~   "
24769|NCT03242798|"~     Cirrhosis is the twelfth leading cause of death worldwide. Malnutrition is prevalent among~     cirrhotic patients and is an important prognostic factor. Nutritional assessment is therefore~     crucial for identifying patients at risk or with already established malnutrition and refer~     them for nutritional intervention and support. In the current literature, nutritional~     assessment of cirrhotic patients is performed using several tools and methods. However their~     accuracy is widely affected by the underline disease and its complications. In addition, for~     the majority of the parameters under study, no gold standard tools and methods have been~     established so far. Studies on nutritional assessment in cirrhosis usually focus on one or~     few aspects of nutritional status and not on a full nutritional assessment combining~     information from medical, biochemical, nutritional, and body composition variables. Hence,~     the present study aims at a thorough assessment of the nutritional status of 170 cirrhotic~     patients using multiple widely available tools and methods, in order to assess their accuracy~     and estimate the prevalence of multiple malnutrition phenotypes such as undernutrition,~     sarcopenia, sarcopenic obesity and cachexia.~   "
24770|NCT03242785|"~     The ADAMPA study is a pragmatic randomized clinical trial which aims to evaluate the~     effectiveness of an intervention based on self-monitoring and self-titration of medication in~     poorly controlled hypertensive patients 40 years and older. The total duration of the study~     is 3 years, with 6 months of enrolment and 1 year of follow-up to measure the primary~     endpoint (Difference in mean systolic blood pressure, in mmHg, between the intervention and~     control groups).~   "
24771|NCT03242772|"~     Children with comorbid autism spectrum disorder (ASD) and attention deficit hyperactivity~     disorder (ADHD) have significantly worse outcomes than those with either ASD alone or ADHD~     alone. Effective early treatments that account for ADHD symptoms have not been developed for~     young children with ASD. The overarching goals of this randomized, placebo-controlled, phase~     2, pilot study are to (1) evaluate a novel early intervention that pharmacologically~     addresses ADHD symptoms prior to initiating early behavioral intervention, and (2) identify~     changes in behavioral and neurophysiological activity that may underlie improved outcomes in~     children with comorbid ASD and ADHD. The primary aim of this study is to evaluate whether a~     stimulant treatment augments efficacy of a novel, parent-delivered, behavioral intervention~     based on the Early Start Denver model (P-ESDM). Secondary aims are to determine the efficacy~     of combined intervention in improving ADHD symptoms and the efficacy, safety, and~     tolerability of Adzenys-XR-ODT in young children with ASD+ADHD. The study will also examine~     correlations between behavioral changes and state-of-the-art eye-gaze tracking (EGT) and~     electroencephalographic (EEG) biomarkers to elucidate key ways in which ADHD impacts~     attentional and neural functioning in ASD+ADHD, and to potentially identify new targets for~     intervention in children with ASD+ADHD. The study is about 1 year long (52- 60 weeks).~     Eligible participants will be randomly assigned to the active medication or placebo, which~     will be administered over the course of 24 weeks (weeks 0-24). The behavioral intervention~     with coaching will be provided for 12 weeks (weeks 10-22) to all participants. Between weeks~     24 to 52 participants will continue behavior intervention without coaching and will be given~     the option to pursue ADHD medication outside of the research study.~   "
24772|NCT03242759|"~     This is a non-interventional, multi-center study to collect data from patients with~     idiopathic pulmonary fibrosis (IPF) in clinical practice in Taiwan. The study will be carried~     out at 10 medical centers, the expert centers where IPF patients are mainly managed in~     Taiwan.~   "
24773|NCT03242746|"~     This study aims to assess how the proportion of the cervical volume/length removed during~     treatment for cervical intraepithelial neoplasia (CIN) varies and whether this correlates to~     the pregnancy duration at delivery~   "
24774|NCT03242733|"~     Evaluation of gastric contents in fasted elderly patients with hip fracture. The gastric~     contents will be examined by using ultrasonography in fasted elderly patients scheduled for~     hip fracture surgery. The primary outcome is the number of patients with stomach contents,~     and the secondary outcome is the component of residual gastric contents.~   "
24775|NCT03242720|"~     With this pilot study, we are hoping to test the feasibility of a larger study in the future~     and to learn whether positive airway pressure therapy reduces the recurrence risk of atrial~     fibrillation after successful catheter ablation procedure among patients with atrial~     fibrillation and obstructive sleep apnea. The results from this study will help us refine the~     design for a future larger study, and will ultimately improve care of patients with~     obstructive sleep apnea and atrial fibrillation.~   "
24776|NCT03242707|"~     A new generation of minimally manipulated regenerative treatments are being offered at~     clinics across the country, but there is no strong efficacy data to support their use. This~     study will evaluate the efficacy of intra-articular autologous adipose tissue for patients~     with mild-to-moderate knee OA, and determine how these treatments effect the biochemical~     environment of the knee by comparing pre-injection and post-injection synovial fluid~     biomarker profiles.~   "
24777|NCT03242694|"~     This prospective observational study is designed to describe the factors determining the~     success of pulmonary vein isolation (PVI) for patients with persistent atrial fibrillation~     (AF). These factors - described as left atrial (LA) function - are simultaneously studied by~     multi-modal techniques in patients undergoing radiofrequency ablation. The simultaneous~     measurements are conducted before the PVI in AF and after the sinus rhythm converted due to~     PVI. These measurements include invasive LA pressure monitoring, LA voltage map creation, LA~     strain evaluation by transthoracal echocardiography, LA scar-mapping by cardiac MRI, defining~     biomarkers from blood samples. During the one year follow-up period rhythm monitoring is~     conducted by regular Holter-monitoring. Our aim is to define the predictive values of the~     above mentioned factors and to create a new score system for predicting PVI success in~     persistent AF population.~   "
24801|NCT03242382|"~     Non-randomized, open, single cohort, phase II, multicenter national clinical trial. 19 sites~     in Spain.~      Palbociclib will be administered orally at a dose of 125 mg once a day for 21 consecutive~     days followed by 7 rest days to comprise a complete cycle of 28 days.~      Treatment will continue until disease progression, development of unacceptable toxicity,~     non-compliance, withdrawal of consent by the patient or investigator decision~      The main goal is to determine progression-free survival rate (PFSR) according to RECIST 1.1~     at 6 months~   "
43971|NCT02991261|"~     The objective of the study is to determine the relative bioavailability, safety and~     tolerability of SPARC001 and Reference001 in healthy, adult, male and female subjects~   "
24778|NCT03242681|"~     The aim of this study is to compare results of endoscopy assisted nasolacrimal probing with~     the standard simple probing in cases with congenital nasolacrimal duct obstruction .~     Furthermore, investigators will identify associated anatomical anomalies. Investigators~     believe results of this study can be valuable in better understanding of this disease and~     provide a high evidence level necessary to propose a classification and management algorithm.~      Children with symptoms of unilateral or bilateral congenital nasolacrimal duct obstruction,~     no past surgical management, with one or more of the below criteria will be included:~        1. Non-resolving symptoms of epiphora and/or discharge.~        2. Congenital dacryocele not resolved after 1 week of lacrimal sac massage, and topical~          antibiotics.~        3. As soon as subsidence of acute dacryocystitis. Parents will be asked about symptoms and~          patients will undergo lacrimal tests before and after operation in one week, one month~          and 3months based on a special record form. Patients will be randomly assigned to~          simple probing group or endoscopy assisted probing group.~      All operations will be performed in operative theater and under general anesthesia. Pre- and~     post-operative examinations will be performed in plastic clinic in Farabi hospital.~   "
24779|NCT03242668|"~     To access the analgesic efficacy of patient controlled thoracic paravertebral analgesia.~   "
24780|NCT03242655|"~     People who inject drugs (PWID) represent the overwhelming majority of both HCV and HIV/HCV~     infected people in the United States. Though new, direct-acting HCV medications are highly~     efficacious and have the potential to end the HCV epidemic, few PWIDs ever initiate~     treatment. We seek to improve HCV treatment uptake and cure among HCV and HIV/HCV+ PWIDs by~     testing a primary care based HCV Group Evaluation and Treatment UPtake (HCV GET-UP)~     intervention. If efficacious, this innovative care intervention could provide a means to~     reduce the growing mortality from HCV, as well as decrease the current reservoir for HCV~     transmission.~   "
24781|NCT03242642|"~     Multi-center, global, prospective, randomized, interventional, pre-market trial with two~     subject groups: the randomized group will be randomized on 1:1 basis to either the study~     device or to conventional mitral valve surgery. Subjects in the single-arm group will receive~     the study device.~      Subjects will be seen at pre- and post-procedure, discharge, 30 days, 6 months, and annually~     through 5 years.~   "
24782|NCT03242629|"~     To compare the clinical sedative effect and safety using 10% chloral hydrate during~     ophthalmic examinations for oral vs enema group.The patients were randomly divided into two~     groups (oral group and enema group) using a computer random number generator with a 1:1~     allocation (simple randomization, odd number for oral group and even number for enema group).~   "
24783|NCT03242616|"~     Pemetrexed is a multi-targeted anti-folate, that is used for non-small cell lung cancer and~     mesothelioma. There are several clinical studies of pemetrexed in breast cancer, but these~     are largely done before the wide use of premedication (steroid and vitamin B12) for~     pemetrexed. Moreover, it has not been studied in combination with vinorelbine, which is a~     commonly used drug for anthracycline- and taxane-pretreated metastatic breast cancer.~      This is a randomized phase II study of pemetrexed plus vinorelbine versus vinorelbine in~     patients with recurrent or metastatic breast cancer previously treated with or resistant to~     an anthracycline and taxane.~   "
24784|NCT03242603|"~     Neuroblastoma is a neoplasm of the sympathetic nervous system which affects mostly children~     younger than 5 years of age. It is a heterogeneous disease, with nearly 50% of patients~     presenting with a high-risk phenotype. After standard treatment, the 2-year event-free~     survival (EFS) for high risk neuroblastoma (EFS) is only about 50%. Immunotherapy with~     anti-GD2 antibodies has been shown to improve EFS in Children's Oncology Group and SIOPEN~     trials.~      The anti-GD2 antibody mediates neuroblastoma cell killing primarily through~     antibody-dependent cell-mediated cytotoxicity (ADCC). Natural killer (NK) cells are the main~     effectors of ADCC. We postulate that infusion of expanded activated NK cells from healthy~     haploidentical donors along with anti-GD2 antibody will enhance neuroblastoma killing.~   "
24785|NCT03242590|"~     Multicenter, open-label, one treatment study evaluating the efficacy of LPCN 1021 in adult~     hypogonadal male subjects.~   "
24786|NCT03242577|"~     This is a single-center, exploratory comparative pilot study to identify the most appropriate~     method for microbial consortia sampling from the skin.~      Ten subjects are expected to complete the study at one investigative site in the United~     States.~      The study will consist of 2 visits, Visit 1 (Screening), Visit 2 (Sampling). At Visit 1,~     subjects will be consented and have their eligibility reviewed. Visit 1 and Visit 2 may be~     combined into one visit. Visit 1 will involve the informed consent process, screening, and~     enrollment. Visit 2 will involve sampling of eight (8) test sites on the back with three (3)~     different sampling methods: swabbing (2 sites/method), cup scrub (2 sites/method), and tape~     stripping (4 sites/method). All samples will be returned to Kimberly Clark then sent to a~     laboratory for analysis.~   "
24787|NCT03242564|"~     The purpose of this study is to determine whether red light therapy using LED 650nm red light~     for body contouring of the waist, hips and thighs is as effective as red light therapy using~     Laser 635nm red light.~   "
24788|NCT03242551|"~     The BINC-B trial is a diagnostic and interventional study in which various function imaging~     methods as Magnetic Resonance Imaging (PWI, DWI and DCE-MRI) and will be compared with common~     imaging methods (mammography and/or ultrasound) to investigate if an early response to a~     combined neoadjuvant chemotherapy in operable or potentially operable breast cancer. For~     breast cancer patients with positive HER-2, additional Herceptin could improve the response~     further. In this study the efficacy of combined neoadjuvant therapy with or without Herceptin~     should be evaluated and the role in predicting the tumor response with different imaging~     should be estimated.~   "
24789|NCT03242538|"~     The investigators hypothesize that two pelvic relaxation exercises will be feasible and safe~     to perform by subjects daily before radiation during the participant's treatment and will~     decrease variability of sacral slope measurements on daily port films. The investigators will~     observe trends in the daily variability and change in the sacral slope in each participant to~     determine if this could decrease variability. The investigators will compare these~     measurements to a retrospective cohort that did not have the exercises, but did demonstrate~     variability. Reducing set-up variability (which inadvertently occurs during radiation) is~     important to improve radiation targets and diminish potential adverse effects. The~     investigators will query participants for objective and subjective feedback on the exercises~     and record frequency and duration of the two exercises.~   "
24792|NCT03242499|"~     Background: Recent evidence has shown that statins, especially lipophilic statins, may have a~     neuroprotective benefit in Parkinson's disease (PD). We aim to perform a randomized~     placebo-controlled trial evaluating the disease-modifying efficacy of lovastatin in patients~     with early stage PD.~      Methods and Study Design: This study will be a phase II, single-center, double-blind,~     randomized, placebo-controlled parallel-group study. In this trial, we are going to examine~     the possibility that lovastatin, a highly potent lipophilic statin, has disease-modifying~     effects in PD. We are going to enroll 80 patients with early stage PD patients. Subjects will~     then be randomized to a 48-week double-blind treatment period of lovastatin 80mg/day or~     placebo. Primary endpoints are changes in motor severity based on Movement Disorder~     Society-Unified Parkinson's Disease Rating Scale motor sub-score (MDS-UPDRS part III, with~     higher numbers indicating more severe disease). During the follow-up period, the dose of~     anti-parkinsonism could be added if both the patients and doctors thought the clinical~     condition deteriorated. Changes in PD medication as measured by levodopa-equivalent dose~     (LED) will be recorded at each visit. The secondary endpoints measured include MDS-UPDRS~     total scores, Part I and Part II sub-scores, the timing and dose of added anti-parkinsonism~     medication during the treatment period, the changes of 18F-DOPA PET uptake and MMSE scores,~     and global impression scale (GCI) of patients and investigators at the end of the study.~      Expected results: We hypothesize that lovastatin would slow down both motor and cognitive~     symptoms deterioration and dopaminergic neuronal degeneration in patients with early stage~     PD.~      Importance of the study: Our study will provide Class II evidence that intensive lipid~     lowering with lovastatin 80 mg/day decrease the disease progression in patients with early~     stage PD.~   "
24793|NCT03242486|"~     Evaluate efficacy and safety of the toric IOL implanted into aphakic eye with corneal~     astigmatism after cataract surgery.~   "
24794|NCT03242473|"~     Acute pancreatitis is increasingly common diagnosis in children. Most of the guidelines~     related to the details of management of acute pancreatitis are extrapolated from the adult~     literature. There is only limited data regarding management of acute pancreatitis in~     children. The mainstay of management is bowel and pancreatic rest with significant fluid~     support to minimize the effect of the cytokines on the pancreas and other organs. The~     standard fluid choices are Lactated Ringer's solution (LR) and normal saline (NS). Currently,~     both LR and NS are used at the discretion of the treating physician as the standard of care~     for acute pancreatitis. The investigators hope to examine the question of ideal fluid choice~     for fluid resuscitation in children with acute pancreatitis by assessing recovery time in the~     context of measured inflammatory markers and SIRS status at 24 and 48 hours after admission.~     The ideal fluid choice in the initial resuscitation of acute pancreatitis has not been~     effectively evaluated before in the pediatric population. Even if there is no statistically~     significant difference between the two fluid options, this trial will still provide~     clinically significant information.~   "
24795|NCT03242460|"~     In Korea, VMP is most commonly used as frontline treatment in patients with newly diagnosed~     MM who were ineligible for high-dose therapy. Recently National Insurance began to reimburse~     the second-line LD when the bortezomib-containing treatment failed to salvage the patients.~     Patients who have relapsed MM after exposure to the above agents and have progressive disease~     have a short life expectancy. Third-line therapy is needed for retrieving the patients~     hereafter. And substantial proportion of patients will attain an advanced age. To examine if~     time to disease progression is maintained and tolerability is improved with lower~     dexamethasone dose, the dose of dexamethasone is reduced when at least a minimal response is~     achieved after 3 months of treatment with the initial dose. Three months later (6 months~     after the initial treatment), the response remains in stable disease, 2nd dose reduction~     (dexamethasone 10mg or prednisone 50mg) will be carried out.~   "
24796|NCT03242447|"~     The purpose of the study is to determine the impact of the offer to participate in the~     e-Practice Self-Regulation (e-PS-R) (treatment) relative to the control condition on~     increasing knowledge of sexual health and the impact of trauma on sexual decision-making and~     preventing teen pregnancy and high-risk behaviors 12 months after enrollment.~   "
24797|NCT03242434|"~     This longitudinal, prospective study aims to establish the magnitude and time course of~     changes in intestinal permeability; establish the optimal method for assessment of intestinal~     permeability in thermally injured participants: describe the participant population most~     likely to benefit from a new medicinal product which could prevent changes in intestinal~     permeability; and improve our understanding of the links between intestinal damage, changes~     in the gut microbiome and microbial translocation to the systemic circulation following~     thermal injury. The key factors of interest in this study are to understand the impact of~     thermal injury on intestinal permeability in thermally injured participants compared to~     healthy participants; and to understand the changes in intestinal permeability over time.~     Approximately 15 eligible healthy participants and 25 thermally injury participants will be~     included. The sugar test material (STM) comprises of Lactulose, Mannitol and Sucralose and~     will be intermittently administered enterally to all the participants. The full duration of~     the study for healthy participants will be approximately two weeks and 6 months for thermally~     injured participants. In order to enter this study thermally injured participants will be~     required to co-enroll in this study and an allied study entitled: A Multi-center, Prospective~     Study to Examine the Relationship between Neutrophil Function and Sepsis in Adults and~     Children with Severe Thermal Injury (SIFTI-2). (reference number IRAS ID: 200366).~   "
24798|NCT03242421|"~     Binocular vision tests are guided by the principle that uniform motion and focus of the eyes~     may be trained, but exercising the simultaneous movement of the pupils is necessary and~     important in achieving optimal and lasting results (Horwood & Toor, 2014). These tests have~     been in use for over 70 years and represent the foundation of therapy for visual deficiencies~     such as the inability of the eyes to move together. Despite their frequent use, no one has~     ever formally evaluated how good these tests are.~      One such evaluation method is reliability. A reliable test is one that will give the same~     result when repeated on multiple occasions (i.e. test-retest reliability) or by different~     people (inter-rater reliability). An unreliable test gives widely varying results when~     repeated, which would make changes in a patient's test results difficult to interpret.~     Therefore, this study aims to determine the test-retest reliability of seven binocular vision~     tests across two independent measurements. The investigators will measure 20 healthy people~     ages 18 to 35 years for each of these tests on two separate occasions, one week apart. Since~     these tests have been in use for many years, we are expecting the two measurements to be~     within acceptable range of each other.~      The tests being investigated measure: 3D vision (i.e. gross stereoscopic acuity), uniform~     movement of the eyes (i.e. motor punctum proximum), ability of the eyes to adapt to a~     target moving towards and/or away from the eyes (i.e. binocular fusion with convergence and~     divergence), quick movements of the eyes (i.e. saccadic movements), natural alignment of the~     eyes (i.e. anatomic oculomotor deviation), and double vision as a target is moved towards the~     eyes (i.e. convergence fusional proximum).~      The results of each test will be analyzed individually. If the tests are perfectly reliable,~     we would expect the results of the first test to equal the results of the second test for~     each participant. To examine the test-retest reliability the difference between the first and~     second test for each individual and across all individuals' scores summed together will be~     assessed.~   "
24799|NCT03242408|"~     This is a multicenter, open-label, one treatment study evaluating the efficacy of LPCN 1021~     in adult hypogonadal male subjects.~   "
24872|NCT03241446|"~     A prospective, open-label, single center, study to evaluate pharmacokinetics and dosimetry of~     intravenously injected Tc 99m tilmanocept at three mass doses (50 µg, 200 µg, and 400 µg)~     radiolabeled with 10 millicuries (mCi) Tc 99m.~   "
24804|NCT03242343|"~     This is a prospective clinical study of the VasQ external support for arteriovenous fistulas.~     The device is designed to improve fistula outcomes by optimizing the geometrical~     configuration of the fistula, influencing hemodynamics, minimizing turbulence and promote~     laminar flow.~      All patients will be implanted with the VasQ device and will be followed up for a duration of~     24 months.~   "
24805|NCT03242330|"~     The objective of this trial is to find out if there is a difference between single-piece and~     two-piece titanium patient-specific mandibular subperiosteal implants in terms of implant~     survival, patient satisfaction, and soft tissue dehiscence. This is to enhance both surgical~     and prosthetic outcomes for the sake of improved implant longevity, soft tissue health and~     patient well-being.~   "
24806|NCT03242317|"~     The objective of this study is to evaluate the Raindrop® Near Vision Inlay for the~     improvement of near vision in presbyopes treated with low dose, short duration Mitomycin C~     (MMC) during surgery and an extended low dose steroid regimen after surgery.~   "
24807|NCT03242304|"~     Acute ischemic stroke (AIS) represents an economical challenge for health systems all over~     the globe. Despite increasing knowledge of the pathophysiology of AIS, there is no~     satisfactory treatment to revert the resulting brain damage. Changes of neuroactive steroids~     have been found in different neurological diseases. In this regard, the investigators have~     previously demonstrated that old patients with AIS show changes of plasma cortisol and~     estradiol concentrations, in that increased steroid levels are associated with a~     deterioration of neurological status and a worse cognitive decline. The present study~     assessed in patients with AIS if changes of behavior, brain-derived neurotrophic factor~     (BDNF) and nitrites (NO-2) (nitric oxide soluble metabolite) bear a relationship with the~     degree of hypercortisolism. To this purpose, the investigators recruited patients~     hospitalized at the Central Military Hospital emergency room within the first 24 hours of~     AIS. Subjects were divided into two groups, each one composed of 40 control subjects and 40~     AIS patients, including men and women. The neurological condition was assessed using the~     NIHSS and the cognitive status with the Montreal Cognitive Assessment (MoCA test). The~     emotional status was evaluated using the Montgomery-Asberg Depression Rating Scale (MADRS),~     whereas the Modified Rankin Scale (MRS) was used to determine the functional condition. BDNF~     and NO-2 plasma levels were measured by ELISA and the Griess reaction method, respectively.~   "
24808|NCT03242291|"~     This study will be conducted to evaluate the Marginal integrity of Hydroxyapatite Nanofiber~     reinforced flowable composite compared to a conventional resin-based flowable composite~     during management of initial carious lesion in adult population over a one year period.~   "
24809|NCT03242278|"~     The primary objective is to assess the proportion of Non-valvular atrial fibrillation (NVAF)~     patients receiving the standard dose of 20 mg of rivaroxaban or the reduced dose of 15 mg of~     rivaroxaban.~      The secondary objective is to determine if dosing patterns for rivaroxaban may be influenced~     by baseline chronic kidney disease (CKD) status (as a proxy for measured baseline renal~     function).~   "
24810|NCT03242265|"~     This study will look at measuring the activity of natural killer (NK) cells using the in~     vitro diagnostic device NK Vue in subjects being screened for prostate cancer using prostate~     biopsy.~   "
24811|NCT03242252|"~     Primary Objective:~      To demonstrate the superiority of sotagliflozin dose 1 and 2 versus placebo on HbA1c~     reduction in patients with Type 2 diabetes who have inadequate glycemic control and moderate~     renal impairment~      Secondary Objectives:~        -  To assess the effects of sotagliflozin dose 1 and 2 versus placebo with respect to~          additional measures of glycemic control, blood pressure, and body weight~        -  To evaluate the safety of sotagliflozin dose 1 and dose 2 versus placebo~   "
24812|NCT03242239|"~     The purpose of this study is to compare ALT02 (Trastuzumab biosimilar) and Herceptin®~     (US-licensed Trastuzumab and EU-licensed Trastuzumab) in healthy male subjects about the~     pharmacokinetics, safety, tolerability and immunogenicity.~   "
24813|NCT03242226|"~     The purpose of this study is to evaluate the effect of +3.00ADD vs single vision spectacle on~     the progression of myopia in children. Many studies applying bifocals or multifocal~     spectacles to intervene the progression have been carried out based on the idea that myopia~     was caused by excessive accommodation, however, the effect was limited. The possible reason~     is that bifocal or multifocal spectacles still not fully adjust the accommodative error in~     myopia children.~   "
24814|NCT03242213|"~     The current randomized controlled trial is a pilot study that will assess the effectiveness~     and feasibility of a mobile phone application intervention. The objective is to determine~     whether the use of a mobile health application for patient self-management of depression~     improves patient-provider engagement for patients diagnosed with major depressive disorder.~   "
24815|NCT03242200|"~     The purpose of this research study is to understand if a mobile app is useful to assist young~     adult female survivors of childhood cancer in the self-management of survivorship-related~     needs.~   "
24816|NCT03242187|"~     This study is designed to assess the surgical, oncological and functional outcome of either~     the laparoscopic or trans-anal TME in management of mid and low rectal cancer.~   "
24817|NCT03242174|"~     To assess health and lifestyle behavior of pregnant women in Baton Rouge including women~     receiving traditional obstetrical prenatal care and delivering in a hospital and those~     receiving prenatal care from a midwife and delivering at the birth center.~   "
24818|NCT03242161|"~     This study is designed to test LabPatch-alcohol, a wearable, non-invasive biosensor Band-Aid~     like patch that is designed to detect real-time changes in interstitial alcohol~     concentrations in human subjects. The changes in interstitial alcohol concentrations will be~     compared to blood alcohol concentrations to determine the patch's validity against the gold~     standard.~   "
24819|NCT03242135|"~     role of RDW as anon invasive method for predicting liver cell failure & portal hypertension~     in cirrhotic patient~   "
24820|NCT03242122|"~     The study is open-label with a randomized, cross-over design using standard Gl methodology.~   "
24953|NCT03240393|"~     A phase II study to evaluate antitumor activity of oral cMET inhibitor INC280 in adult~     Chinese patients with EGFR wild-type, advanced non-small cell lung cancer (NSCLC) who have~     received one or two prior lines of systemic therapy for advanced/metastatic disease as~     measured by overall response rate (ORR). The study will also evaluate safety and~     pharmacokinetics of INC280.~   "
24821|NCT03242109|"~     Cardiovascular disease and malignancies account for more than 70% of all causes of mortality~     and morbidity in Italy. There is a subtle balance between genetic determinants and lifestyle,~     that often defines the line between health and sickness. So far studies aiming at identifying~     risk factors have mainly come from Northern Europe and the USA. It was to understand this~     balance between genetics and environmental determinants better, and to tailor appropriate~     preventive strategies for Italian and other Southern European populations, that the Moli-sani~     study was launched, transforming a small Italian region into a large scientific laboratory:~     the Molise lab.~      Each participant received a thorough medical check-up at no cost to either him/her or the~     national health service, resulting in thousands of hours of free public health care. With a~     completely computerized system, Moli-sani is a paperless study, in which researchers and~     participants communicate using recently developed technologies such as mobile phone text~     messages (SMS). The biological data bank (the MoliBank) is one of the largest in Europe.~     Paying particular attention towards innovation and new technologies, the Moli-sani study has~     placed itself at the cutting edge of a new paradigm crossing research and prevention~   "
24822|NCT03242096|"~     Treatment of coronary in-stent restenosis (ISR) by a sirolimus coated SEQUENT® SCB RAPID~     EXCHANGE PTCA balloon catheter or a paclitaxel coated SEQUENT® PLEASE PTCA balloon catheter~   "
24823|NCT03242083|"~     Age-related macular degeneration (AMD) is a major cause of deep visual acuity loss. Because~     of progressive deterioration of the macula, patients with AMD complain about progressive~     visual problems that can impair their quality of life in the physical, mental and social~     domains. The principal objective principal of this study is to describe the evolution of~     quality of life between the diagnosis of secondary atrophic AMD and at 18 months after~     confirmation of diagnosis.~   "
24824|NCT03242070|"~     The high prevalence of chronic illnesses is a serious public health problem in the U.S., and~     more than 70 million adults age ≥50 have at least one chronic illness. Management of chronic~     conditions requires long-term use of complex treatment plans and can cause unintended~     consequences, such as increased risk of medication errors. Patient portals (PPs), a federally~     supported health information technology (IT), can be especially helpful for patients with~     chronic illnesses. Patients can now access their own health records and directly communicate~     with care providers through PPs. Prior findings suggest a great potential for using PPs to~     improve care quality, and the federal government funds healthcare organizations to implement~     this tool nationwide. Despite the potential benefits, the overall PP adoption rate in the~     U.S. is low. A lack of PP use among older adults has been addressed as a particular concern.~     When only older adults who use the Internet are considered, however, their proportion of PP~     use is similar to other age groups. A few studies also reported that older adults are~     receptive to PPs. In general, older adults need additional support for learning to use PPs,~     as they tend to be less familiar with technology. Currently, most older adults receive little~     or no PP support from their providers. This is an important gap in the nation's health IT~     initiative because without appropriate support, older adults will not be able to use this~     robust health tool, missing an important opportunity to improve their health outcomes. In an~     effort to fill this gap, the investigators developed and tested an older adult friendly~     Theory-based Patient portal eLearning Program (T-PeP) to support older adults in using PPs~     for their care. In the proposed feasibility study, the investigators plan to (Aim 1) optimize~     and implement a vendor-agnostic T-PeP and conduct formative and process evaluations; and (Aim~     2) assess the preliminary impact of T-PeP on PP use and selected outcomes (PP knowledge,~     self-efficacy for PP use and health decision making, health communication, and medication~     reconciliation). If successful, this study could directly affect quality of care provided to~     older adults and the success of the national health IT initiative. Findings from this study~     will also provide hospitals, vendors, and policymakers with in-depth information on older~     adults' current PP usage patterns and other challenges in using various types of PPs at the~     national level.~   "
24825|NCT03242057|"~     Extubation failure is a significant problem in preterm neonates and prolonged intubation is a~     well-documented risk factor for development of chronic lung disease. Out of the respiratory~     modalities available to extubate a preterm neonate; high flow nasal canula, nasal continuous~     positive airway pressure (nCPAP) and noninvasive positive pressure ventilation (NIPPV) are~     the most commonly used.~      A recent Cochrane meta-analysis concluded that NIPPV has lower extubation failure as compared~     to nCPAP (30% vs. 40%)~      NAVA (neurally adjusted ventilatory assist), a relatively new mode of mechanical ventilation~     in which the diaphragmatic electrical activity initiates a ventilator breath and adjustment~     of a preset gain (NAVA level) determines the peak inspiratory pressure. It has been reported~     to improve patient - ventilator synchrony and minimize mean airway pressure and ability to~     wean an infant from a ventilator. However till date there has been no head to head comparison~     of extubation failure in infants managed on NAVA with conventional ventilator strategies.~      In this study the investigators aim to compare primary extubation failure rates in~     infants/participants managed by NIPPV vs. NI-NAVA (non invasive NAVA). Eligible~     infants/participants will be randomized to be extubated to predefined NIPPV or NI-NAVA~     ventilator settings and will be assessed for primary extubation failure (defined as~     reintubation within 5 days after an elective extubation).~   "
24826|NCT03242044|"~     Congenital diaphragmatic hernia (CDH) is a severe birth defect, with a prevalence of 1:2000~     to 1:3000 live births where a defect in the diaphragm results in, herniation of the abdominal~     contents into the chest with subsequent compression of the intrathoracic structures and~     respiratory insufficiency after birth. Respiratory insufficiency is managed with intubation~     and mechanical ventilation. In addition to managing respiratory insufficiency, intubation~     prevents entrainment of air into the intestines and further compression of the lungs and~     heart. Resuscitation of infants with CDH also involves placement of a nasogastric tube (NG)~     into the stomach for removal of entrained air and secretions. As part of routine~     resuscitation in infants with CDH intubation and NG tube placement are performed after the~     delivery personnel separates the baby from the placenta by cutting the umbilical cord. This~     study will assess the feasibility, maternal and fetal tolerance and the optimal approach to~     performing these initial steps of resuscitation with an intact umbilical cord. The~     investigators have randomly chosen 10 maternal and infant with congenital diaphragmatic~     hernia dyads to demonstrate feasibility as well as determine pitfalls and difficulties and~     the optimal approach to a complex resuscitation with an intact umbilical cord.~   "
24827|NCT03242031|"~     Despite the fact that the efficacy of a single session of multispot laser has been~     demonstrated in the treatment of patients with diabetic retinopathy as compared with four~     sessions of single-spot laser, the management of panretinal photocoagulation in the different~     healthcare establishments in France has remained unchanged notably because there is no~     specific reimbursement for this new treatment protocol.~      Although the benefits of reducing the number of sessions and thus the costs associated with~     the treatment for the patient and the payer seem to be obvious, the medico-economic impact of~     modifying the treatment strategy thanks to the technological changes must be evaluated to~     provide deciders with additional information.~   "
24828|NCT03242018|"~     Primary Objective:~      To demonstrate the superiority of sotagliflozin dose 1 versus placebo with respect to~     hemoglobin A1c (HbA1c) reduction in patients with Type 2 diabetes who have inadequate~     glycemic control and severe renal impairment~      Secondary Objectives:~        -  To assess the effects of sotagliflozin dose 2 versus placebo based on change from~          baseline in HbA1c~        -  To assess the effects of sotagloflozin doses 1 and 2 versus placebo~        -  To evaluate the safety of sotagliflozin doses 1 and 2 versus placebo~   "
24829|NCT03242005|"~     Open label, randomized 2-period cross-over study comparing two continuous subcutaneous~     insulin infusion sets ; MiniMed® Pro-set® with BD FlowSmart™ technology and MiniMed®~     Quick-set®~   "
24830|NCT03241992|"~     This study will be the first to assess the use of an electronic health records patient portal~     for patients with Inflammatory Bowel Disease. Patients with Inflammatory Bowel Disease (IBD),~     have reduced quality of life, high rates of depression and anxiety, do not receive routine~     preventative health maintenance (such as vaccines) at the same rate as the general public,~     and have low adherence to medications. The investigators are seeking to understand whether an~     electronic health record patient portal (EPIC's MyChart), can be utilized to improve quality~     of life in this patient population.~   "
24831|NCT03241979|"~     Transnasal High-flow rapid-insufflation ventilatory exchange (THRIVE) has been shown to~     benefit oxygenation, ventilation and upper airway patency in a range of clinical scenarios,~     however its use in spontaneously breathing pediatric patients undergoing tubeless airway~     surgery has not been described. This is a physiologic study that evaluates the feasibility of~     THRIVE during pediatric airway surgery under self-respiration.~   "
24832|NCT03241966|"~     The investigators are examining how aspects of daily function are perceived in persons with~     PD and in those who interact with them on a regular basis. If eligible, participants will~     receive a set of online questionnaires by email. The questionnaires will take about 1 hour to~     complete, and can be done at the participant's convenience. The investigators are looking for~     volunteers who have a diagnosis of Parkinson's disease without dementia (age 40 or older and~     proficient English speakers). If a spouse, family member, significant other or other close~     associate is available (age 18 or older, proficient English speakers), the investigators will~     send them questionnaires as well. There is no monetary or other compensation for this study.~     For more information, please contact the Vision and Cognition Laboratory at~     vcognition@gmail.com or 617-358-1377.~   "
24833|NCT03241953|"~     In this randomized, controlled study, 18 patients with peri-implantitis were included. A~     total of forty dental implants were debrided with either ultrasonic instruments (test, n=20)~     or plastic scaler (control, n=20). Gingival recession depth (RD), keratinized tissue width~     (KTW), probing depth (PD), Gingival Index (GI) were evaluated at baseline and after 6 months.~     CBCT radiographs were used to evaluate peri-implant bone loss. Supportive and nonsurgical~     periodontal therapies were firstly consulted to reduce the inflammation, occurring due to the~     surgical treatments of the defects. The formation of bacterial biofilm on implant surfaces~     was removed by ultrasonic scaler and air polishing using abrasive powders or conventional~     plastic scaler with klorhegsidin combination.~   "
24834|NCT03241940|"~     This phase I trial studies the best dose and side effects of CD19/CD22 chimeric antigen~     receptor (CAR) T cells when given together with chemotherapy, and to see how well they work~     in treating children or young adults with CD19 positive B acute lymphoblastic leukemia that~     has come back or does not respond to treatment. A CAR is a genetically-engineered receptor~     made so that immune cells (T cells) can attack cancer cells by recognizing and responding to~     the CD19/CD22 proteins. These proteins are commonly found on B acute lymphoblastic leukemia.~     Drugs used in chemotherapy, such as fludarabine phosphate and cyclophosphamide, work in~     different ways to stop the growth of cancer cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Giving CD19/CD22-CAR T cells and~     chemotherapy may work better in treating children or young adults with B acute lymphoblastic~     leukemia.~   "
24835|NCT03241927|"~     Melanoma is an immune-modulated malignancy and immune checkpoint modulators which inhibit~     PD-1 function (pembrolizumab, nivolumab) have demonstrated clinical efficacy as treatment for~     patients with stage IV melanoma. Pembrolizumab across a range of doses in phase I~     investigation has demonstrated clinical efficacy with RR approximately 27%. By better~     understanding how NK cell function and exhaustion interplays with PD1 function and activity,~     potentially more efficacious combination therapies can be developed. The pharmacodynamic~     studies to be performed as part of this trial will provide such information.~   "
24836|NCT03241914|"~     To see if megestrol acetate plus Levonorgestrel-releasing intrauterine system (LNG-IUS) will~     not be inferior to returning the endometrial tissue to a normal state than megestrol acetate~     alone in patients with early endometrial cancer.~   "
24837|NCT03241901|"~     This clinical trial evaluates the advantage of prolonging the therapeutic life span of~     Artemether-lumefantrine from 3 days to 6 days, and addition of single low dose of Primaquine~     0.25mg/kg. The study will have two arms, one that will receive standard treatment of~     uncomplicated malaria with Artemether-lumefantrine, and the other arm will receive the~     prolonged dose of 6 days together with single low dose primaquine. This approach is expected~     to provide strategies for malaria control in an era of imminent Plasmodium falciparum~     resistance.~   "
24838|NCT03241888|"~     To see if megestrol acetate plus Levonorgestrel-releasing intrauterine system (LNG-IUS) will~     not be inferior to returning the endometrial tissue to a normal state than megestrol acetate~     or LNG-IUS alone in patients with endometrial atypical hyperplasia.~   "
24839|NCT03241875|"~     The aim of this study is to evaluate the effect of premedication with pregabalin or~     gabapentin versus placebo on postoperative shoulder pain after laparoscopic cholecystectomy.~   "
24873|NCT03241433|"~     This study is a single-center RCT. Potential subjects with symptomatic non-permanent AF will~     be enrolled to determine the effect of sprint interval training (SIT) in comparison to~     moderate-intensity continuous training (MICT) and non-exercise control in reducing AF burden.~     The Investigators will enroll 60 patients during the first 12 months of the study. Baseline~     data collection will be conducted during the first month after enrollment. After baseline~     data collection, subjects will be randomized (1:1:1) to SIT vs. MICT vs. non-exercise~     controls. The exercise training will last for 3 months followed by final data collection~     which will be completed in 1 month.~   "
24840|NCT03241862|"~     20 subjects with mild to severe oral commissures or none to severe perioral lines will be~     enrolled and injected with Restylane® Silk. Photographs will be taken prior to and 14 days~     after Optimal Cosmetic Results has been achieved, as judged by the investigator.~      Changes in the projected first impression will be assessed by a total of 200 blinded~     evaluators rating the photographs of subjects from the baseline and from 14 days post~     achieving the Optimal Cosmetic Results. Changes in subjects' mood will be self-assessed~     through Subjective Happiness Scale and Happiness Measures questionnaires. Aesthetic~     alterations will be assessed by the investigator via the Global Aesthetic Improvement Scale,~     Oral Commissure Severity Scale, and the Perioral Lines Severity Scale as well as by the~     self-assessment of subjects using the Global Aesthetic Improvement Scale.~   "
24841|NCT03241849|"~     Placenta accreta is an obstetrical complication where the placenta becomes firmly adherent to~     the uterine wall. Placenta accreta can lead to considerable maternal morbidity and mortality~     due to hemorrhage, infection, or other surgical complications such as those resulting from~     hysterectomy. Retained placenta accreta is usually a rare condition, but its prevalence is~     increasing due to the rise in the rate of deliveries by Cesarean section.~      Placenta accreta is a potentially life-threatening obstetric condition that requires a~     multidisciplinary approach to management. The incidence of placenta accreta has increased and~     seems to parallel the increasing cesarean delivery rate. Women at greatest risk of placenta~     accreta are those who have myometrial damage caused by a previous cesarean delivery with~     either an anterior or posterior placenta previa overlying the uterine scar. Diagnosis of~     placenta accreta before delivery allows multidisciplinary planning in an attempt to minimize~     potential maternal or neonatal morbidity and mortality.~   "
24842|NCT03241836|"~     Pelvic floor failure is a common disorder that can seriously jeopardize woman's quality of~     life by causing urinary, fecal incontinence, difficult defecation and pelvic pain. Multiple~     congenital and acquired risk factors are associated with pelvic floor failure including~     altered collagen metabolism, female sex, vaginal delivery, menopause, and advanced age. A~     complex variety of fascial and muscular lesions that range from stretching, insertion~     detachment, denervation atrophy, and combinations of pelvic floor relaxation to pelvic organ~     prolapse may manifest in a single patient.~      The prevalence of pelvic floor dysfunction increases with age. It is approximately 9.7% in~     child bearing period (20-39 yrs), while it reaches up to 49.7% by 80 yrs and older.~      Thorough preoperative assessment of pelvic floor failure is necessary to reduce the rate of~     relapse, which is reported to be as high as 30%.~      MR imaging is a powerful tool that enables radiologists to comprehensively evaluate pelvic~     anatomic and functional abnormalities, thus helping surgeons provide appropriate treatment~     and avoid repeat operations.~      Real time 2D trans-perineal ultrasound is emerging as an exciting new technique for pelvic~     floor assessment. It has advantage of providing a global view of the entire pelvic floor,~     from the symphysis to the ano-rectum, and includes the lower aspects of the levator ani~     muscle, in addition to its lower costs and greater accessibility; also sonographic imaging is~     more useful in the clinical environment, and generally better tolerated than MRI.~   "
24843|NCT03241823|"~     Hepatitis C Virus (HCV) infection is a major global health challenge; it is estimated that~     more than 80 million people are chronically infected worldwide, with 3-4 million new~     infections and 350,000 deaths occurring each year because of HCV-related complications .~   "
24844|NCT03241810|"~     This study is a multi-center, randomized, double-blind, placebo-controlled, Phase 2 study in~     postmenopausal women with heregulin positive, hormone receptor positive, HER2 negative~     metastatic, unresectable breast cancer.~   "
24845|NCT03241797|"~     The aim is to evaluate EUS-FNA efficacy for AIP diagnosis using a 22-gauge (G) needle.~   "
24846|NCT03241784|"~     This is an open-label pilot study to determine the safety and tolerability of infusions of~     autologous CD4+ CD25+ regulatory T cells with concomitant subcutaneous IL-2 injections in 4~     subjects with ALS.~   "
24847|NCT03241771|"~     In the setting of naloxone standing orders, this study will assess if direct outreach with a~     web-based Naloxone Navigator 1.0 to patients prescribed chronic opioid therapy (COT)~     changes opioid risk behaviors, increases naloxone uptake, and increases knowledge about~     overdose and naloxone~   "
24848|NCT03241758|"~     A study designed to evaluate vascular changes after radical laparoscopic prostatectomy using~     Doppler ultrasound and the impact of such changes on erectile function and quality of life of~     patients. The baseline study will be compared with the study one year after surgery.~   "
24849|NCT03241745|"~     The purpose of this study is to test the safety of nivolumab and find out what affects, if~     any, nivolumab has on people and their risk of uterine cancer. The investigators also want to~     find out what effects, good or bad, nivolumab has on the patient and their cancer.~   "
24850|NCT03241732|"~     Chronic Traumatic Brain Injury (cTBI) symptoms exist in individuals who experienced previous~     traumatic brain injuries. There are 80-90 thousand individuals who are clinically diagnosed~     with cTBI, with estimated costs at greater than 60 billion dollars. However, there is a lack~     of studies using comprehensive diagnostic imaging tools to better understand physiological~     ramifications of the injury that may help guide therapy.~   "
24851|NCT03241719|"~     The objective of this study is to develop a feasible and safe regimen for minimization of~     immune suppression in recipients of vascularized composite allotransplants (VCA) using a~     daily dose of recombinant IL-2. In order to achieve this aim, this trial will:~        1. Perform VCA in 5 eligible subjects;~        2. Administer recombinant IL-2 at a low-dose to promote the expansion and function of~          regulatory T cells in subjects who received VCA; and~        3. Minimize immune suppression to tacrolimus single therapy in subjects who received VCA~          and recombinant IL-2.~      This trial will also investigate if it is possible to predict immune rejection in VCA using~     blood and tissue samples from recipients of VCA.~      Lastly, this trial will develop non-invasive technologies to monitor for VCA rejection. These~     technologies will involve magnetic resonance imaging. Multi-contrast ultra-high resolution MR~     imaging (MRI) with serial direct planimetry will be performed in recipients of VCA.~   "
24874|NCT03241420|"~     To determine the utility and sensitivity of the lung clearance index (LCI) technique as a~     marker of small airways disease in adults with chronic lung conditions compared to healthy~     adults, adjusting for age, sex and smoking status.~   "
24852|NCT03241706|"~     The purpose of this research study is to learn more about how sugar levels in the liver~     affect the ability of people both with and without type 1 diabetes. People with type 1~     diabetes do not make their own insulin, and are therefore required to give themselves~     injections of insulin in order to keep their blood sugar under control. However, very often~     people with type 1 diabetes give themselves too much insulin and this causes their blood~     sugar to become very low, which can have a negative impact on their health. When the blood~     sugar becomes low, healthy people secrete hormones such as glucagon and epinephrine (i.e.,~     adrenaline), which restore the blood sugar levels to normal by increasing liver glucose~     production into the blood. However, in people with type 1 diabetes, the ability to release~     glucagon and epinephrine is impaired and this reduces the amount of sugar the liver is able~     to release.~      People with type 1 diabetes also have unusually low stores of sugar in their livers. It has~     been shown in animal studies that when the amount of sugar stored in the liver is increased,~     it increases the release of glucagon and epinephrine during insulin-induced hypoglycemia. In~     turn, this increase in hormone release boosts liver sugar production. However, it is not~     known if increased liver sugar content can influence these responses in people with and~     without type 1 diabetes. In addition, when people with type 1 diabetes do experience an~     episode of low blood sugar, it impairs their responses to low blood sugar the next day. It is~     also unknown whether this reduction in low blood sugar responses is caused by low liver sugar~     levels.~      The investigators want to learn more about how liver sugar levels affect the ability of T1D~     and CON to respond to low blood sugar.~   "
24853|NCT03241693|"~     The aim of this study was to assess the effect of a blended-learning model on physiotherapy~     students´ attitude, knowledge and opinions towards learning professional ethics.~      A simple-blind clinical trial was performed. An eight-month blended learning program to teach~     professional ethics in clinical practices was worked out. An online syllabus and online~     activities were elaborated, whilst face to face active participation techniques were~     performed to discuss ethical issues detected among practices. Students´ attitudes, knowledge~     and opinions towards learning professional ethics were assessed. Non-parametric tests were~     carried out. All the participants were informed about the study and procedures, and provided~     written informed consent.~   "
24854|NCT03241680|"~     Cervical cancer is the third most frequent neoplasm in Brazilian women (estimated risk of~     15.33 cases / 100,000 women by 2014), behind breast and colorectal cancer.~      This high incidence is explained by the pre-neoplastic lesions of the cervix being probably~     related to the practice of unsafe sex and to a poor local immune response against HPV.~      Human papillomavirus (HPV) infection affects people of any age, although it is more common in~     young people, probably due to increased sexual activity in that period.~      The association between high-risk HPV and anus neoplasm in men and women with~     immunodeficiency or immunosuppression has been confirmed and measures related to surveillance~     are standardized.~      In patients without immunodeficiencies, this association is still unclear, which may~     contribute to the lack of adequate standards to diagnose HPV and prevent cancer of the anus.~      The frequency of the cancer of anus previously considered low, is currently in considerable~     elevation, mainly squamous cell carcinoma (SCC).~      The causal relationship between this virus and cancer of the cervix and the anus is~     established. These facts have motivated the inclusion of this disease as STD, which justifies~     the necessity of adopting surveillance measures in the clinics of sexual, gynecological and~     urological diseases.~      Cancer of the anus, when diagnosed in the early stage, makes healing possible with less~     aggressive treatments, but in the advanced stage, abdominoperineal amputation is necessary.~      Concerned about possible anal cancer, some gynecologists have referred patients with genital~     HPV to search for anal infection.~   "
24855|NCT03241667|"~     This is a non-randomized, open label, uncontrolled first in human safety study, testing the~     the material used in the artificial kidney device in subjects already on hemodialysis.~      Six subjects already on hemodialysis, who meet the study inclusion and exclusion criteria,~     and who dialyze at one of the UCSF associated hemodialysis units will be recruited. Each~     subject will be tested during one non hemodialysis day, at the UCSF Moffitt-Long Hospital~     Acute Hemodialysis Unit (AHU).~      The artificial kidney engineers have created a blood flow system that can be substituted for~     the dialysis filter in a standard hemodialysis machine. This is NOT a dialysis filter. It~     allows the subjects blood to come in contact with the material while the blood is being~     circulated as is regularly done during a hemodialysis session.~   "
24856|NCT03241654|"~     In mechanically ventilated patients during supine position, alveolar collapse usually~     distributes in dependent lung region.Decrease of flow trigger sensitivity might improve~     homogeneous of tidal volume distribution.~   "
24857|NCT03241641|"~     Treatment of CHB patients with genotypic resistance to NUCs has been problematic due to the~     lack of data from randomized trials. Recently, two randomized trials comparing the efficacy~     of TDF monotherapy versus TDF and ETV combination therapy in CHB patients with documented~     genotypic resistance to adefovir (ADV) or ETV demonstrated TDF monotherapy was not~     statistically different in viral suppression at week 48 of treatment.1,2 The extension study~     based on the above two trials merged study subjects from these trials with changing from TDF~     and ETV combination group to TDF monotherapy to evaluate long-term efficacy and safety of TDF~     monotherapy for multidrug-resistant patients. At the time of merging of 192 subjects, by~     intention-to-treat analysis, 66.3% of TDF group and 68.0% of TDF-ETV group had virological~     response as determined by serum HBV DNA <15 IU/mL. (in press) Three year long-term follow up~     study showed that the proportion of virologic suppression increased to 76.8% and 72.2% in~     TDF-TDF and TDF/TDF-ETV groups, respectively( P=0.46). (in press)~      TAF, a novel prodrug of tenofovir was developed to have greater stability in plasma than TDF,~     thereby enabling more efficient delivery of the active metabolite to target cells at a~     substantially lower dose. The reduced systemic exposure of tenofovir offers the potential for~     an improved safety profile compared to TDF a benefit that demonstrated in a recent clinical~     trial in patients with HIV infection. In a recent double-blind randomized phase 3~     noninferiority trial with 873 treatment naive patients who were positive for HBeAg, the~     proportion of patients receiving TAF who had HBV DNA <29 IU/mL at week 48 was 64%, which was~     non-inferior to the rate of 67% in patients receiving TDF (P=0.25).3 In the safety profile,~     TAF group had significantly smaller decrease in BMD than TDF group in the hip and spine, as~     well as significantly smaller increases in serum creatinine at week 48.3 For treatment naive~     HBeAg negative patients, a recent study with 425 subjects applied the same methodology and~     showed noninferiority in efficacy of TAF compared to TDF at week 48.4 Considering~     noninferiority in efficacy and superior bone and renal safety from TAF, TAF might be~     considered preferred choice of NUC instead of TDF. However, it is still unknown whether TAF~     would show similar efficacy and safety profile in patients with multidrug-resistant CHB.~   "
24875|NCT03241407|"~     The purpose of this trial was to determine the effect of a triclosan-containing toothpaste in~     the clinical parameters and in the profile of osteo-immunoinflammatory mediators in the~     peri-implant crevicular fluid (PICF) as a preventive therapy of peri-implant experimental~     mucositis in cigarette smokers~   "
24858|NCT03241628|"~     Epidermolysis Bullosa (EB) is a group of genetic conditions causing extensive, painful skin~     blisters and wounds. Four main types of EB are recognised, which all affect the hands but~     those patients usually requiring hand therapy interventions have Recessive Dystrophic EB~     (RDEB).~      The proof of concept study is part of the GLOVE (Generation and evaLuation Of hand therapy~     deVices for Epidermolysis bullosa) project. The project aims (i) to develop two hand therapy~     devices; a disposable dressing glove and splint glove to manage blisters, wounds and~     contractures that occur on the hands of people with RDEB (ii) to design and implement the~     Hand Therapy Online (HTO) electronic patient record system and (iii) to determine the cost~     effectiveness of the devices and the HTO system.~      The proof of concept study focuses on testing the clinical performance and cost effectiveness~     of the dressing glove when compared with conventional dressings.~      Recruited GLOVE participants will be invited to participate in the 14 week study, conducted~     using a quasi-experimental, n-of-1 research design. Patients who have not participated in~     GLOVE will also be invited to join. Participants will be asked to follow their usual dressing~     regime for six weeks. At week 7, they will be given several pairs of dressing gloves to~     replace their usual dressings, or starting to wear the glove if they avoid dressings normally~     and familiarise themselves. If participants usually wear their gloves to maintain their web~     spaces, they will wear these on top of the dressing glove to help assess compatibility.~      Participants will provide feedback twice a week from week 7 on the dressing glove by~     answering 12 questions (TELER indicators) validated in the Pilot study (REC no: 16/LO/1046)~     using the HTO system. Data from the HTO system will be used by the Health Economist to~     determine the dressing glove and HTO's cost effectiveness.~   "
24859|NCT03241615|"~     The aim of the study is to investigate the relationship between dysphagia symptom severity~     and quality of life of the patients with neurogenic dysphagia.~   "
24860|NCT03241602|"~     The advancement of laparoscopy and minimal access surgery has greatly influenced the~     evolution of anaesthetic techniques. However, postoperative pain intensity may be~     significant, with up to 40% of patients unsatisfied by routine analgesia and up to 80%may~     require rescue opioids during their hospital stay. Diagnostic gynaecological laparoscopy has~     no origin of pain other than the abdominal gas insufflations itself only. Pain relief after~     diagnostic laparoscopy, being a day case, is an issue of great practical importance.The aim~     of this study is to compare the efficacy of combining both pulmonary recruitment and~     intraperitoneal lidocaine versus pulmonary recruitment alone to control post - laparoscopy~     shoulder pain regarding severity and frequency~      Study Design :~      Interventional Prospective Randomized Double-blind Controlled Trial~      Methodology This study is a randomized double blinded control trial. It will be conducted at~     Kasr-al ainy hospital, faculty of medicine, Cairo university. Approval of ethical committee~     and written informed consent will be obtained. 88 female patients, aged 18-45 years , ASA 1~     or 2 , scheduled for diagnostic gynaecologic laparoscopy will be included. Females who are~     (ASA) ≥ 3, alcoholic, drug abusers, allergic to amide LAs, with pre-existing chronic pain~     disorders, or receiving opioids or tranquilizers for > 1 week preoperatively are excluded.~     Also if the operation included any interventional procedure or was converted to an open~     procedure, or had postoperative complications that could increase postoperative pain, it will~     be excluded. Consenting patients will be randomly allocated to either of three study groups :~     GPL : Patients will receive pulmonary recruitment maneuver and intraperitoneal lidocaine.~     GPS: Patients will receive pulmonary recruitment maneuver and intraperitoneal saline. GC :~     Patients will receive passive exsufflation through the port site. The patient will attend at~     the pre anaesthetic room 1 hour before the procedure. A 20 Gauge cannula will be inserted~     peripherally and the patient will be premedicated with intravenous Midazolam 0.02 mg kg-1,~     Ranitidine 50 mg, 10 mg Metoclopramide.~      In the operative room, standard monitoring will be applied to the patient. Anaesthesia will~     be induced with propofol 2 mg kg-1, Fentanyl 1 mcg kg-1 , Atracurium 0.5 mg kg-1 and the~     trachea will be intubated after mask ventilation for 3 minutes. Anaesthesia will be~     maintained with IPPV , isoflurane in 100% oxygen and muscular relaxation with atracurium~     0.1mg kg-1every 15 minutes. Depth of anaesthesia was adjusted according to clinical signs.~     Laparoscopy is done using CO2 as distension medium. The patient will be placed in a~     Trendelenburg position in order to provide optimum conditions for laparoscopic view. In~     groups GPL and GPS , the investigator prepares syringes 1.75 ml/kg of 0.2% lidocaine (3.5~     mg/kg) or the same volume of normal saline, for intraperitoneal administration. This ensures~     the surgeon and the anaesthesiologist are blind to the patient's group. The solution to be~     instilled will be splashed under the right diaphragmatic area by the surgeon and complete the~     procedure. At the end of the procedure, the patient will be placed back from trendelenburg~     position. In groups GPL and GPS , a pulmonary recruitment maneuver will be done and consist~     of five manual pulmonary inflations with a maximum pressure of 40 cm H2O. The~     anesthesiologist hold the fifth positive pressure inflation for approximately 5 seconds. In~     group GC CO2 will be removed by passive exsufflation through the port site and gentle~     abdominal pressure will be applied to evacuate the residual gas. Residual neuromuscular block~     is antagonized with atropine 1.2 mg and neostigmine 2.5 mg and extubation will be done~     according to extubation criteria. In the recovery room, patient will be asked about~     post-operative pain and it'll be controlled using Meperidine 1 mg kg-1 and given by a nurse~     who is unaware of the nature of the intraoperative analgesia. Then, the patient is discharged~     to the ward according to the standard criteria. In the ward, patient will be asked to fulfill~     a questionnaire at 6, 8 and 10 hours postoperative using the visual analogue score (VAS) of~     pain severity. Patients were questioned as to presence of Side effects (nausea, vomiting).~      Possible Risk : Pneumothorax , Local anaesthetic toxicity : CNS depression (lightheadedness~     and dizziness, difficulty focusing, tinnitus, confusion, and circumoral numbness) ,~     excitation ( tremors tonic-clonic convulsions) , respiratory depression and cardiac~     dysrhythmias .~   "
24861|NCT03241589|"~     This study will measure the impact of two teledermatology apps, VA Telederm and MY Telederm,~     WITH TWO SEPARATE TRIALS on access to dermatology care. The overall hypothesis is that sites~     implementing Department of Veterans Affairs' (VA) teledermatology mobile apps will~     significantly augment the use of teledermatology and improve Veterans' access to skin care~     relative to control sites. Specifically, the investigators hypothesize that VA Telederm will~     facilitate the implementation and adoption of teledermatology among primary care clinic~     staff, increasing use by existing programs and potentially expanding teledermatology to new~     sites while reducing patient travel to dermatology clinics. Additionally the investigators~     hypothesize that My Telederm will improve established patients' ability to follow-up with~     dermatology care remotely, while opening up dermatology clinic space for other patients.~   "
24862|NCT03241576|"~     In 3 laboratory experiments the effect that receiving a small vs. large portion size of food~     has on later intake of that food was examined~   "
24863|NCT03241563|"~     The subjects and evaluating investigator will be blinded to the treatment, thus maintaining~     double-blind status. By nature of the varying volumes of injection, the treating investigator~     will be unblinded to the treatment. A series of 3 injection sessions will be performed spaced~     4 weeks apart.~      Canfield Vectra 3D imaging will be performed at baseline and at each follow up visit. Follow~     up visits will be performed 3 and 5 days after each injection session to assess for side~     effect and tolerability profile. After the final injection session, additional follow up~     visits will be performed at days 90 and 180 to assess for efficacy. Subject weight will be~     recorded at baseline and at end of study.~   "
24864|NCT03241550|"~     The purpose of the study is to evaluate the pharmacokinetics (PK), safety and tolerability of~     multiple doses of intravenous (IV) isavuconazonium sulfate administered daily in pediatric~     patients. The PK data will be utilized to establish a pediatric population PK model of~     isavuconazole, the active moiety of isavuconazonium sulfate.~   "
24865|NCT03241537|"~     In local advanced prostate cancer patients with clinically positive metastatic regional lymph~     node, the optimal treatment is still unanswered. For these patients, radiotherapy combined~     with hormonal therapy or hormonal therapy alone are recommended. Recently, the reports from~     NCCB and SEER data showed that radiotherapy combined with hormonal therapy have better~     survivals than hormonal therapy alone.~      This randomized phase III trial compare hormonal therapy alone with combined hormone with~     radiotherapy in clinically pelvic lymph node metastatic prostate cancer.~   "
24866|NCT03241524|"~     The sample comprised 31 female undergraduate students attending a private University in João~     Pessoa, northeastern Brazil. The inclusion criteria were: age between 19 and 35 years,~     heterosexual, active sex life, living in a stable relationship for at least 6 months no~     pregnancy or parturition in the last 6 months, clinically healthy and agreeing with the terms~     for participating in the study. All participants gave their informed consent to take part in~     the study.~   "
24867|NCT03241511|"~     The goal of this project is to assess repeated and ongoing oral care and the way it may~     affect inflammation and quality of life in hemodialysis patients. Two treatment groups will~     be compared:~        -  1) ongoing and repeated gum disease therapy including deep tooth cleaning followed by~          multiple appointments of maintenance~        -  2) single session of gum disease therapy with only one session of deep tooth cleaning~          Samples of blood will be obtained for study to examine the changes of inflammatory~          substances in the blood as a result of the two different gum disease treatments. Also, a~          14-question survey will be discussed with you to assess oral health related quality of~          life (OHIP-14) and the way it is affected by oral care.~      For this project, four dialysis centers will be randomly assigned to either of the treatment~     groups #1 or #2 prior to your enrollment. For this purpose, there are two distinct consent~     forms explaining the visits, procedures and risks of the two treatment groups #1 or #2. As a~     result, all participants in the same dialysis center will belong to the same treatment group~     (either #1 or #2) and presented with the corresponding consent form.~      This dialysis center has been randomized to treatment group # 1; therefore you will receive~     ongoing and repeated gum disease therapy including deep tooth cleaning followed by multiple~     appointments of maintenance.~   "
24868|NCT03241498|"~     The study is a United Kingdom (UK) based multi-centre study which will evaluate the impact of~     a medication optimisation intervention (delivered in GP practices by pharmacists to patients~     at risk of medication related problems), on healthcare resource utilisation and patient~     outcomes. Pharmacists in 4 areas across the UK (3 in England and 1 in Northern Ireland) will~     engage with patients, thought to be at a higher risk of medication related problems, within~     their GP practice in order to help identify areas for improvement~   "
24869|NCT03241485|"~     This is a randomized clinical trial in patients undergoing robotic myocardial~     revascularization with intraoperative extubation. Patients will be randomized into placebo or~     intrathecal morphine groups to assess postoperative pain scores and patient satisfaction.~     Patients will also be assessed for side effects from the intervention.~   "
24877|NCT03241381|"~     Melasma is a commonly pigmention characterized by melanotic patches on the face. literature~     searched revealed that periodontitis and vitamin D deficiency have occurred along with~     anemia. Actinic associated factors may be indirectly related to vitamin D, melasma~     contributes to sun exposed area of face.To correlate melasma with clinical evidence of~     periodontitis and vitamin D serum analysis along side hb %. Patients with facial melasma~     between 30-70yrs of either gender formed Group A (95). Anaemia and periodontitis were~     Clinically checked. Additionally serum analysis of vitamin D and hb percentage were analysed.~     Similar procedure was carried out on controls which had Group B (95) patients with no melasma~     on face.~      The study revealed significant correlation between melasma and periodontitis with vitamin D~     abnormalities (p value<.05), where as insignificant correlation between melasma and Hb%. The~     correlation between melasma, vitamin d changes and periodontitis may prompt the clinician to~     check for any such changes in any patient. Melasma in patients with periodontitis and serum~     vitamin D changes might be a considered as a syndrome.~   "
24878|NCT03241368|"~     This study will evaluate the efficacy of capsule endoscopy (CE) versus ileocolonoscopy (IC)~     plus MRE for detection of active Crohn's disease (CD) in the small bowel in subjects with~     known CD and mucosal disease.~      The primary objective of the study is to assess the accuracy of CE versus IC plus MRE for~     detecting active CD, by visualizing the small bowel and colon in subjects with known CD and~     mucosal disease.~      There will be assessment of mucosal disease activity at baseline and 6- and 12- month follow~     ups. Patient satisfaction questionnaires will be completed at baseline, 6- and 12- month~     follow ups along with a Quality of Life questionnaire at 12 month follow up. Concomitant~     medication and adverse events information will be collected baseline and 3-, 6-, 9- and 12~     month follow ups.~   "
24879|NCT03241355|"~     The study aims to explore whether prophylactic dietary supplementation with prebiotic~     inulin-type fructans is able to influence the intestinal microbiota and the frequency of~     infectious disease episodes in kindergarten children during a winter period.~   "
24880|NCT03241342|"~     GTx-024 is an orally bioavailable and tissue-selective nonsteroidal selective androgen~     receptor modulator (SARM) that has demonstrated androgenic and anabolic activity and is~     currently being evaluated as a potential treatment for stress urinary incontinence (SUI) in~     postmenopausal women. Urinary incontinence and pelvic floor disorders are major health~     problems for women, especially as they age. Pelvic floor muscle relaxation has been found to~     correlate with lower urinary tract symptoms including SUI. Muscles of the pelvic floor and~     lower urinary tract are crucial for supporting the pelvic organs and micturition; however,~     damage to the muscles or lack of hormonal stimulation are thought to contribute to pelvic~     organ prolapse and urinary incontinence. Although anabolic steroids may increase muscle mass~     and strength, lack of oral bioavailability and known potential risks have limited their use.~     Nonsteroidal SARMs have potential to achieve benefits of anabolic steroid therapy (improved~     muscle mass, cholesterol/triglyceride levels, glucose metabolism, and bone density) with~     fewer adverse effects, such as hirsutism and acne, in women. Both nonclinical and clinical~     data suggest that SARMs may provide a new therapeutic option for pelvic floor and lower~     urinary tract disorders, as both testosterone and its more potent metabolite,~     dihydrotestosterone, have anabolic effects on muscle.~   "
24881|NCT03241329|"~     The aim of this study is to evaluate the impact of endometriosis on folliculogenesis and~     oocyte quality. To do so, a metabolomic approach will be conducted in order to analyze the~     follicular fluid. This evaluation will be completed by a trancriptomic analysis from the~     cumulus cells of the oocyte.~      The normal and pathological oocyte cohort after controlled ovarian stimulation will be also~     characterized by identifying the oocyte leading to live birth.~   "
24882|NCT03241316|"~     The investigators will conduct two rural surveys in Thailand and Lao PDR to improve the~     understanding of antibiotic-related health behaviour among the general population. One survey~     will capture a cross-section of health behaviours that is representative for the rural~     population in Chiang Rai (Thailand) and Salavan (Lao PDR), the other survey will create a two~     round village-level panel data set to study the evolution of health behaviours in the context~     of public engagement activities. The investigators will also collect complementary data about~     village-level infrastructure through observational check-lists, and collect secondary data on~     patient load from primary care units catering to their survey villages. As part of the~     questionnaire testing process, the investigators will conduct (and collect as primary data)~     cognitive interviews to improve the survey tool, to interpret their data, and to justify~     their methodological choices.~   "
24883|NCT03241303|"~     Investigation of GLP-1 signalling in the glucose-lowering effect of increased carbohydrate~     content in the distal small intestines induced by alpha-glucosidase inhibition during meal~     ingestion in patients with type 2 diabetes~   "
24884|NCT03241290|"~     THALES-EVAQUAL study assesses the quality of the images generated by C-ARM ARCO FP-Rk521S and~     its ability to be used during surgery.~   "
24885|NCT03241277|"~     Objective: To investigate the impact of nonsurgical periodontal treatment in patients with~     social anxiety disorder (SAD) and controls without phobia.~   "
24886|NCT03241264|"~     The purpose of this study is to evaluate the safety, tolerability, and the effects two~     ND-L02-s0201 have on the body~   "
24887|NCT03241251|"~     The Psychosocial Assessment Tool (PAT) is an international used instrument for the screening~     for psychosocial risk factors in families of a child with cancer. This study want to~     investigate the validation and evaluation of the clinical value of the Flemish translation of~     the psychosocial assessment tool~   "
24888|NCT03241238|"~     This study will investigate the effects of different fermenting fibers on liking of foods.~   "
24916|NCT03240874|"~     Diabetes during pregnancy is a challenging clinical situation requiring substantial patient~     engagement. The investigators have developed a novel early-phase tool, called SweetMama,~     incorporates educational, motivational and supportive elements to positively impact maternal~     health behaviors. This phase of work involves develop an optimized version of SweetMama via a~     2-step sequential process of in-depth usability testing - focus groups and individual~     usability testing followed by refinement of SweetMama based on participant input.~   "
28103|NCT03199144|"~     The goal of the present study is to test if in situations of borderline resectable patients a~     neoadjuvant treatment combining Gemzar-Abraxane and stereotactic radiosurgery could increase~     the median OS rates above 30 months that means at least 12 months more than the 18-20 months~     generally described.~   "
24889|NCT03241225|"~     The investigators developed EM/PROTECT, a behavioral intervention for depressed EM (elderly~     mistreatment) victims, to work in synergy with EM mistreatment resolution services that~     provide safety planning, support services, and links to legal services. PROTECT is built on a~     model which postulates that chronic stress promotes dysfunction of the cognitive control~     (CCN) and reward networks, impairing the victims' ability to flexibly respond to the~     environment and limits their reward activities. PROTECT therapists work with victims to~     develop action plans to reduce stress, and to increase rewarding experiences. EM/PROTECT has~     been designed in an iterative process with community EM providers of the New York City (NYC)~     Department for the Aging (DFTA) to use agencies' routine PHQ-9 depression screening and~     referral for service. In the current study, the investigators will compare the effectiveness~     of EM/PROTECT with EM enriched with staff training in linking EM victims to community mental~     health services (EM/MH). The investigators intend to enroll 80 subjects that will participate~     in the study for approximately 12 weeks.~   "
24890|NCT03241212|"~     This study is a randomized controlled trial assessing diabetes knowledge (using a Mercy-What~     I Know About Diabetes Test (MWIKAD) validated survey) and self-care practices (using a~     validated Self-management of Type 1 Diabetes-Adolescence (SMOD-A) survey) at baseline, 3~     months and 6 months. The intervention group will receive a minimum of 78 text messages~     related to diabetes over the course of 26 weeks from study enrollment. Subjects are invited~     to respond to some text messages which will be in the form of a multiple-choice question and~     if they do, they will receive an additional text message in response to their answer.~   "
24891|NCT03241199|"~     The purpose of this pilot study is to investigate whether some patients who were started on a~     2G-TKI as first-line treatment can be safely switched to imatinib, a first-generation TKI,~     while maintaining or even deepening the molecular response as a cost-effective treatment.~     Eligible patients will be switched to imatinib 400mg daily, with regular molecular~     monitoring.~   "
24892|NCT03241186|"~     The trial is a single arm phase II clinical trial of Ipilimumab and Nivolumab in patients~     with resected mucosal melanoma. Ipilimumab (1 mg/kg) and Nivolumab (3 mg/kg) will be~     administered day 1 of a 21-day cycle in cycles 1-4 and then nivolumab 480 mg will be~     administered day 1 of a 28-day cycle for cycles 5-15 or until disease recurrence.~   "
24893|NCT03241173|"~     The purpose of this study is to determine the safety, tolerability, and efficacy of~     INCAGN01949 when given in combination with immune therapies in participants with advanced or~     metastatic malignancies.~   "
24894|NCT03241160|"~     The study is planned to determine the relationship between chewing performance level and~     gross motor function, and trunk postural control in cerebral palsy (CP).~   "
24895|NCT03241147|"~     This study will evaluate the pharmacokinetics of Lu AF35700 after a single dose tablet to~     subjects with renal impairment (kidney insufficiency) and compare that with healthy subjects~   "
24896|NCT03241134|"~     An experimental study will be conducted to evaluate the effect of a single dry needling~     session, compared to a sham needling session, on surface EMG activity (signal amplitude and~     frequency) and pain of the upper trapezius muscle, in office workers with trapezius myalgia.~   "
24897|NCT03241121|"~     SwissChronoFood - Study of eating patterns with a smartphone app and the metabolic effects of~     time restricted feeding in metabolic syndrome~      The purpose of this study is to assess eating patterns among teenagers and adults with a new~     method, going beyond the pen-and-paper food diaries, and to investigate whether time~     restricted feeding leads to weight loss, improvement in lipid and glucose metabolism in~     individuals with metabolic syndrome~   "
24898|NCT03241108|"~     This is a Phase 2, PoC, randomized, placebo-controlled, double blind, international~     multicentre study to explore the effect of a new antibody to treat patients with Rheumatoid~     Arthritis~   "
24899|NCT03241095|"~     The purpose of the study is to investigate if osteopathic manipulative treatment (OTM)~     improves the golf swing of the participants. Study participants will be randomized into three~     groups, we will stratify by age and gender to make them as uniform as possible. One group~     will receive no intervention other than a 10-minute break between the pre and post~     measurements. A second group will receive a sham intervention where the doctor will pretend~     to give the participant OTM. The third group will receive real OTM.~      Participants will perform a sample of 10 golf swings pre and post intervention which will be~     measured by a golf simulator. They will also complete a brief health history and pre/post~     self-evaluation of their swing.~   "
24900|NCT03241082|"~     The overall objective of the proposal is to evaluate the ability of ultrasound to predict and~     routinely (weekly) monitor changes in the body composition of healthy preterm infants in the~     neonatal intensive care unit (NICU) in response to nutritional intake. The investigators~     hypothesize that ultrasound is an accurate method to routinely monitor the quality of weight~     gain and assess the adequacy of nutritional provision for premature infants in the neonatal~     intensive care unit.~      The investigators will address the hypothesis in the following Specific Aims:~      Specific Aim 1: Validate ultrasound as a method to measure whole body fat mass and fat free~     mass in healthy, premature infants. Body composition will be assessed using ultrasound~     measurements and the validated method of air displacement plethysmography (ADP). Stable~     isotope dilution techniques will be used in a subset of our population as a secondary source~     of validation.~      Specific Aim 2: Determine whether ultrasound measurements can detect clinically relevant~     (weekly) changes in body composition in healthy premature infants. Ultrasound will be used to~     obtain serial (weekly) measurements of muscle and adipose tissue thickness (triceps, abdomen,~     quadriceps) until discharge in healthy, premature infants.~   "
24901|NCT03241069|"~     Dynamic variations of bio-impedance measured cardiac output using pharmacologic (inhaled~     nitrate) and non pharmacologic intervention (sitting position, passive leg rising and~     valsalva maneuver) could be used to detect acute heart failure in patients admitted to the ED~     for dyspnea.~   "
24952|NCT03240406|"~     This is a pilot randomized controlled clinical trial is designed to investigate whether the~     Multicultural Healthy Diet (MHD), an anti-Inflammatory diet tailored to a multi-cultural~     population, can improve cognitive functioning in a middle aged (40-65 yr) urban population in~     Bronx, New York compared to a usual diet.~   "
28149|NCT03198533|"~     The objective is to investigate the Clinical, Radiographic, Roentgen Stereophotogrammetric~     behaviour and patient outcome when using the Triathlon total knee prosthesis in a prospective~     randomized clinical trial.~   "
24902|NCT03241056|"~     A small (N = 24) pilot study developed a new and brief cognitive-behavioural therapy (CBT)~     module for checking symptoms (CBT-C) in obsessive-compulsive disorder (OCD). CBT-C targets~     maladaptive beliefs about memory and results show that it is effective at significantly~     decreasing checking symptoms as compared to a waitlist control. The objectives of the current~     investigation are to further investigate CBT-C by (1) replicating the pilot results in a~     larger sample; (2) using an active control condition (treatment as usual) as the comparison~     condition (3) including a 6-month follow-up, and (4) determining whether the association~     between maladaptive beliefs about memory at pre-treatment assessment are related to degree of~     checking symptom reduction following CBT-C. The findings of the study will have theoretical~     significance in adding to our understanding of the maladaptive belief domains relevant to the~     development and maintenance of OCD and supporting the cognitive model of compulsive checking.~     The relevant clinical significance is the further development of an intervention that could~     improve outcomes in treatment of persons with OCD. The key practical outcome of the research~     would be to add a stepped care offering to patients with OCD.~   "
24903|NCT03241043|"~     Single centre, open-label, randomized, controlled, cross over study to evaluate the~     pharmacokinetic and bioavailability of Envarsus® in comparison to Advagraf® in de novo liver~     transplant recipients~   "
24904|NCT03241030|"~     The purpose of this study is to see if sucralfate, a medication commonly used for patients~     with stomach ulcers, may help pediatric patients with mouth ulcers decrease their pain level~     and improve their ability to drink.~   "
24905|NCT03241017|"~     The trial assess the progression-free survival (PFS) two years after autologous stem cell~     transplantation (ASCT) in high-risk DLBCL patients receiving PD-L1 inhibition with~     durvalumab.~   "
24906|NCT03241004|"~     This study aims to determine if anesthetic depth can be deepened non-pharmacologically~     through use of sleep masks. This study seeks to demonstrate a relationship between the depth~     of anesthesia with application of sleep masks intraoperatively and in the critical care~     setting.~   "
24907|NCT03240991|"~     This study aims to describe quality of life in hereditary or acquired non drug-related~     bradykinin-mediated angioedema patients, using validated questionnaires~   "
24908|NCT03240978|"~     Overweight/obese Chinese and prediabetes will be recruited and divided into three age-matched~     groups including high intensity exercise, moderate intensity exercise, and non-exercise~     groups. The exercise program will consist of three sessions per week over the course of 12~     weeks, under the supervision of our in-house exercise specialists and physiologists. The~     effects of exercise on glucose and lipid profiles, insulin sensitivity and adiposity will be~     evaluated.~   "
24909|NCT03240965|"~     This study evaluates changes in swallowing using endoscopic swallowing studies and measuring~     of pharyngeal sensitivity, taste and smell in stroke patients. Younger (<60 years) and older~     (>60 years) volunteers will serve as control.~   "
24910|NCT03240952|"~     Elderly are at greater risk of dietary insufficiency due to age-related increases in nutrient~     requirements concomitant with a reduction in energy requirements, decreases in appetite and~     energy intake. Currently there is a gap in knowledge of the factors that are associated with~     malnutrition in the elderly in Singapore. In addition, there is no reference database on~     anthropometric measurements and biochemical indices for elderly with a range of nutrition~     status in Singapore. Thus, the objectives of this cross-sectional study are to examine~     factors influencing nutritional status and to determine the reference values for~     anthropometric and biochemical measurements related to nutritional status for~     community-dwelling elderly in Singapore.~   "
24911|NCT03240939|"~     A randomized, open label, single dose, two-way crossover clinical trial to investigate the~     pharmacokinetics and safety/tolerability of YY-201 in comparison to Dutasteride and Tadalafil~     administered in healthy male volunteers~   "
24912|NCT03240926|"~     The main purpose of this study is to assess the accuracy of a non-invasive wearable~     technology in the form of a wristband.~   "
24913|NCT03240913|"~     The primary objectives of this study are to: 1) develop an educational tool known as the~     Patient Reported Outcome Measure informed Decision Aid (PROM-DA) that will describe the~     options for patients considering total knee arthroplasty (TKA) surgery, and help them imagine~     what to expect if they choose either option; 2) assess the extent that the PROM-DA improves~     patients decision quality; 3) determine the feasibility of a larger trial to test the PROM-DA~     in multiple sites and more patients.~   "
24914|NCT03240900|"~     Described as the Angelina Jolie Effect, rates of prophylactic mastectomy with immediate~     implant-based reconstruction are increasing dramatically as more women with genetic~     predisposition towards breast cancer are seeking surgical prevention. Advances in surgical~     techniques allow for the creation of an aesthetically pleasing postoperative breast mound;~     however, a common complaint is the lack of sensation to the skin and nipple of the~     reconstructed breast due to injury and stretch of the sensory nerves. Numbness of the breast,~     nipple, and areola is an unnatural feeling for the patient, as well as a potential risk for~     injury or burns as the woman is unable to feel pain.~      Our laboratory has previously shown that electrical stimulation (ES) is an effective way of~     improving nerve regeneration after injury to the nerves of the upper and lower extremities.~     Proven to improve motor outcomes following carpal and cubital tunnel release and sensation~     following injury to the digital nerves, this technique is a likely mechanism of restoring~     sensation of the breast as well.~      In this study, we will follow thirty women undergoing prophylactic skin-sparing mastectomy~     with immediate implant-based reconstruction. At the time of surgery, patients will be~     randomly assigned ES to either the right or left breast. That breast will be reconstructed~     first and stimulated for one hour while the other breast is reconstructed. At the completion~     of the case, all wires will be removed. We will test sensation (tactile, temperature, 2-point~     discrimination, sharp/dull discrimination, and protective sensation) prior to surgery then~     again at 6, 12, 18, and 24 months following surgery to evaluate the effects of ES on sensory~     return. Patients will be provided with a survey to assess return of erogenous sensation.~   "
24915|NCT03240887|"~     A randomized control trial will be conducted in high schools in North Carolina and New York~     City to determine the impact of a school-based, positive youth development program on both~     sexual behaviors associated with teen pregnancy and education outcomes.~   "
24917|NCT03240861|"~     This phase I clinical trial evaluates the safety and feasibility of administering NY-ESO-1~     TCR (T cell receptor)engineered peripheral blood mononuclear cells (PBMC) and peripheral~     blood stem cells (PBSC) after a myeloablative conditioning regimen to treat patients with~     cancer that has spread to other parts of the body. The conditioning chemotherapy makes room~     in the patient?s bone marrow for new blood cells (PBMC) and blood-forming cells (stem cells)~     to grow. Giving NY-ESO-1 TCR PBMC and stem cells after the conditioning chemotherapy is~     intended to replace the immune system with new immune cells that have been redirected to~     attack and kill the cancer cells and thereby improve immune system function against cancer.~   "
24918|NCT03240848|"~     In this study, the investigators provide participants≤14 years old the artificial intelligent~     clinic or normal clinic in the purpose of seeking out a better way to make a definite~     diagnosis with high efficiency and accuracy, and report a prospective, randomized controlled~     study aiming at comparison of artificial intelligent clinic and normal clinic for diagnosing~     congenital cataract.~   "
24919|NCT03240835|"~     The purpose of this study is to study the function of pre-albumin, retinol conjugated protein~     and transferrin in early malnutrition detecting and nutritional status dynamic monitoring for~     local advanced nasopharyngeal carcinoma patients with chemoradiotherapy.~   "
24920|NCT03240822|"~     This is a 4-year, non-randomized, single center, patient self-controlled, clinical trial~     (though enrolled subjects will be followed for life as are all transplant patients) for~     patients seeking allotransplantation of the male external genitalia (MEG), or penile tissue,~     as a feasible reconstructive strategy for the treatment of devastating and irreversible~     injuries to the genitalia. In addition to receiving penile allotransplantation and~     post-operative monitoring and support, enrolled patients will receive an innovative and~     clinically proven immunomodulatory protocol that combines lymphocyte depletion of the~     recipient with donor bone marrow cell infusion. Patients will be treated with lymphocyte~     depleting induction therapy, donor bone marrow cell infusion and tacrolimus. After the first~     year, maintenance immunosuppression will be modified gradually and cautiously (tapered dose~     reduction or spaced frequency dosing of tacrolimus) in selected patients based on a critical~     evaluation of clinical and immunologic outcomes. Outcomes will include but not be limited to~     functional metrics (sensation, erection, voiding), psychosocial (body integrity, adaptation~     to transplant) and health related quality of life (HRQOL) measures.~   "
24921|NCT03240809|"~     An Open-label, Single-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of~     Brodalumab in Pediatric Subjects~   "
24922|NCT03240796|"~     In this study, the investigators give participants who had a lens implantation before a~     secondary intraocular lens implantation in the purpose of reduce complications of surgeries~     for dense cataract , and report a prospective, non-randomized controlled study aiming at~     comparison of minimal invasive lens surgery and traditional cataract surgery for treating~     congenital cataracts~   "
24923|NCT03240783|"~     Aim: In subjects with acute sciatica (≤ 4 weeks duration), this is a pilot comparative~     effectiveness study to evaluate feasibility and to determine final sample size for a future~     adequately powered randomised controlled trial of (i) CT-guided transforaminal lumbosacral~     epidural steroid injection, and (ii) oral dexamethasone, in a masked (blinded), randomised,~     sham injection and oral placebo controlled trial.~      Study Design: 60 patients with acute sciatica will randomised 1:1:1:1 to receive either (i)~     epidural steroid injection & oral placebo, (ii) epidural normal saline injection & oral~     placebo, (iii) oral dexamethasone & IM sham-injection, (iv) IM sham-injection & oral placebo.~      Outcomes: The primary outcome is reduction of disability at 3 weeks using the Oswestry~     Disability Index. Secondary outcomes include reduction of disability at 6 and 48 weeks.~   "
24924|NCT03240770|"~     The investigators hypothesize that brief, daily application of HFA will increase the~     efficiency of clear aligner treatment by altering PDL metabolism without increasing pain or~     discomfort. The investigators will divide subjects into 5 groups changing clear aligners at~     different time intervals with or without HFA application for 5 minutes/day to assess the~     effect on: time intervals between aligners, cytokine activity, and pain perception.~   "
24925|NCT03240757|"~     In the present study the investigators compared the hormonal and metabolic effects of three~     meal loads very popular among Italian eating habits, both in the resting- and exercising~     state. Given the lack of time is considered a common barrier to exercise adherence, we wanted~     to identify a low dose of exercise capable to produce health benefits in the post-absorptive~     status elicited by three commonly consumed meal-models in Mediterranean countries. To this~     end, healthy young volunteers firstly underwent an oral glucose tolerance test (OGTT) and~     three meal tolerance tests. Secondly, in an extra set of experiments, subjects cycled at low~     intensity for the last 20 minutes of the same glucose/meal tolerance test. Glycemia,~     insulinemia, ghrelinemia, lipidemia, and satiety were measured throughout OGTT and each~     test-meal load.~   "
24926|NCT03240744|"~     Enterovirus 71 (EV71), a major pathogen causing hand-foot-and-mouth disease (HFMD) worldwide,~     is a member of the Human Enterovirus species A, family Picornaviridae. Its infection~     occasionally leads to severe diseases and death, with central nervous system (CNS) damage.~      Recently, except of inactivated vaccine, several EV71 vaccine candidates have been evaluated~     in animals but no final results of clinical trials, such as attenuated vaccine, subunit~     vaccine. A formalin-inactivated EV71 vaccine (Human Diploid cell, KMB-17 Cell) has been~     finished phase I, II and III clinical trials and licensed by SFDA in China at Dec. 3, 2015.~     Based on the results of clinical trials, the protective efficacy of inactivated EV71 vaccine~     is 97% against HFMD caused by EV71. The phase IV clinical trial has been carried out from~     July 2016. The purpose of phase IVc is to evaluated the immunogenicity of the inactive EV71~     vaccine in large scale population of Chinese children (from 6 to 71 months old) in Hubei~     Province, China.~   "
24927|NCT03240731|"~     multicentric interventional biomedical research phase II, prospective, non-randomized~     evaluating a haploidentical marrow transplants after reduced-intensity conditioning and~     prevention of GvHD based on cyclophosphamide administration post transplantation in patients~     with severe sickle cell disease.~   "
24928|NCT03240718|"~     This is a randomized, controlled, within-patient, single-blinded, pilot study that will~     evaluate the impact of laser treatment on burn HSc relative to self-matched control scars.~     The studied primary outcomes of treatment are scar pliability, thickness, vascularity, pain,~     itch and patient satisfaction.~   "
24929|NCT03240705|"~     Clerkship causes significant stress to medical students. Some interventions to increase~     well-being have been described but none have been studied prospectively in this context.~      The primary objective of this study is to examine the effects of gratitude journaling on~     medical clerks' perceived well-being.~      Students will be randomised to one of two groups: gratitude journaling or no intervention.~     The participants of the experimental group will be asked to complete an online gratitude~     journal 3 times per week and will be compared to the participants in the control group.~      The students in both groups will answer a standardised questionnaire evaluating well-being~     before and after their surgical rotation.~      Those randomised to the intervention group will perform gratitude journaling three times a~     week during their surgical rotation. This activity consists of writing something that made~     them feel happy during their day.~      Those randomised in the control group (no intervention) will proceed with their normal~     rotation, without additional gratitude journaling.~      The main outcome will be evaluated by comparing the well-being at the end of the surgical~     rotation as evaluated by a composite well-being assessment scale between both groups.~   "
24930|NCT03240692|"~     This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial~     magnetic stimulation device for treatment-resistant depression. In this open label study, all~     participants will receive accelerated theta-burst stimulation.~   "
24931|NCT03240679|"~     This study is being done to assess the use of scaffold products in promoting constructive~     healing as determined by the ability of the resection site to lift during follow-up.~   "
24932|NCT03240666|"~     The buccal cavity is colonized by numerous microorganisms whose the number and composition~     could be modified with medical background (diseases and drugs) and the level of oral hygiene~     of the patients. Among all microorganisms identified in the periodontium, few of them are~     implicated in the etiopathogenesis of periodontal pathologies. To date, four major bacteria~     are identified for their ability to degrade periodontal tissues.~      Although the periodontitis is established to be the consequence of bacterial virulence and~     immune dysfunction, these factors fail to explain the refractory periodontitis of some~     patients to etiologic treatment .~      Others microorganisms such as protozoans could have an impact on this disease.~   "
24933|NCT03240653|"~     The purpose of this research is to review data already collected and to collect new data from~     adults and children in England with Gaucher Disease to determine clinical factors which~     predict severity and response to therapy of Gaucher disease especially in the areas of bone,~     cancer and brain conditions.~   "
24934|NCT03240640|"~     Shortness of breath (dyspnea) is an important symptom during physical exertion in patients~     with chronic obstructive pulmonary disease (COPD) and is related to respiratory muscle~     weakness. Dyspnea is a multidimensional sensation. The sensory perceptual domain (perceived~     dyspnea intensity) has been study extensively. The perception of respiratory distress~     (unpleasantness of dyspnea) has not received as much attention. Inspiratory muscle training~     (IMT) has been shown to improve inspiratory muscle function and reduce dyspnea intensity.~     Balance impairments increasing the risk of falling is another recognized problem in patients~     with COPD. Postural balance has been shown to be especially impaired in patients with COPD~     who have pronounced respiratory muscle weakness. Improvements in respiratory muscle function~     might improve balance control in patients. Respiratory Muscle Metaboreflex is known as~     respiratory muscle work during exercise reflexively induces sympathetically mediated~     vasoconstrictor activity, there by compromising blood flow and oxygen delivery to active limb~     and respiratory muscles.~      Eight weeks of controlled IMT is hypothesized to reduce both intensity as well as~     unpleasntness domain of dyspnea perception, improve postural control and improves blood flow~     and oxygen delivery to limb muscles in patients with COPD who have pronounced respiratory~     muscle weakness.~   "
24935|NCT03240627|"~     Double-blind, randomised, multi-centre study to evaluate the efficacy and safety of LH-8~     cutaneous solution versus placebo in children and adolescents with moderate to severe scalp~     alopecia areata.~      Phase 2/3 study performed in Germany, Bulgaria and Romania in 100 patients.~   "
24936|NCT03240614|"~     Hypoxemia is a life threatening complication during emergency airway management. Despite~     advances in technology and training, hypoxemia still occurs in up to a quarter of all~     intubations placing patients at high risk for damage to vital organs and death. A key method~     in the prevention of hypoxemia is known as preoxygenation which has been shown to decrease~     the incidence of hypoxemia. Currently there are two conventional methods for preoxygenation~     in the literature, however recently a new method has been described as a possible alternative~     method. What is unclear in the literature is if one modality is superior than the other for~     preoxygenation. The goal of this interventional study is to determine if one method of~     preoxygenation is superior to the other. This is a 3 arm interventional cross over designed~     study comparing three interventional methods for preoxygenation. Non-rebreather mask,~     bag-valve mask and high flow nasal cannulae.~   "
24937|NCT03240601|"~     Involuntary muscle activity, often called spasticity, is a common problem following spinal~     cord injury (SCI) that can make it hard to move. Many things can cause spasticity including:~     muscle stretch, movement, or it can happen for no reason, and it is often described as an~     uncontrolled muscle spasm or feeling of stiffness. Drugs are typically used to treat~     spasticity, but they often have side effects, like muscle weakness, which can add to movement~     problems. Rehabilitation therapies offer alternatives to drugs for treating involuntary~     muscle activity, and rehabilitation can also improve daily function and quality of life.~     These benefits may be greater when several rehabilitation therapies are used together.~      Walking ability can be improved with a type of therapy called locomotor training. This type~     of therapy may also have the benefit of decreasing spasticity. When locomotor training is~     combined with electrical stimulation, the benefits of training may be increased. In this~     study, investigators will use a kind of stimulation called transcutaneous spinal cord~     stimulation (tcSCS) to stimulate participants' spinal cord nerves during locomotor~     training.~   "
24938|NCT03240588|"~     The objective of the study is to characterize the relationship between select objective~     metrics and clinical outcomes in chronic pain patients treated with Boston Scientific~     commercially approved neurostimulation systems.~   "
28150|NCT03198520|"~     To evaluate the change in patient Oral Health-related Quality of Life (OHRQoL) from wearing a~     cobalt chrome (CoCr) removable partial denture (RPD) to wearing the Solvay Dental 360TM~     polymer Removable Partial Denture (RPD) for 8 weeks.~   "
24939|NCT03240575|"~     The primary objective of the trial is to show superiority in lung function of once daily (2~     inhalations) treatment with orally inhaled tiotropium+olodaterol fixed dose combination to~     twice daily (one inhalation) treatment with fluticasone propionate+salmeterol fixed dose~     combination over 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD).~      A Digital Health (DH) exploratory study has been integrated into the main study as a site~     specific study. The DH exploratory study will be performed at a single site; the site is also~     participating in the main study. The DH exploratory study site will enter (randomize)~     approximately 20 patients (subjects) (in addition to the patients to be enrolled in the main~     study at this site). The patients enrolled in the DH exploratory study are not considered to~     be part of the main study (i.e. data collected in the DH exploratory study will be analyzed~     separately from the data collected in the main study).~   "
24940|NCT03240562|"~     The investigators aimed to assess Ultrasounde- guided serratus anterior plane block can be~     effective in acute postoperative pain following thoracic surgery.~   "
24941|NCT03240549|"~     Previous studies have shown that the addition of bevacizumab to the standard first-line~     platinum-based combination therapy can improve the objective response rate of patients with~     advanced non-squamous non-small cell lung cancer by 20% to 28% and improve survival. Data~     from these published literatures suggest that the improvement in objective response rates is~     due mainly to patients with stable disease of chemotherapy. It has been reported that 15% of~     patients achieved objective remission after continuing treatment with the regimen after~     receiving 2 cycles of platinum-based combination chemotherapy. Therefore, the use of 2 cycles~     of chemotherapy after stabilization of patients with bevacizumab, hoping to improve the~     objective response rate of such patients 20%, and may improve survival. For the above~     reasons, design this study to validate our hypothesis.~   "
24942|NCT03240536|"~     This is a randomized study intended to produce a reduction in ordering of inappropriate tests~     by general practitioners as determined by recommendations from the CRA's Choosing Wisely~     guidelines. This reduction of inappropriate testing is expected in referrals to the~     rheumatologists randomized to the intervention group. This study will further explore which~     recommendations from the Canadian Rheumatology Association (CRA)/Canada Choosing Wisely~     campaign have the most impact on regional referring physicians to the Rheumatology clinic at~     St. Joseph's Hospital, London.~   "
24943|NCT03240523|"~     The primary objective of this study is to assess the efficacy of vilaprisan in subjects with~     uterine fibroids compared to ulipristal The secondary objective of this study is to evaluate~     the efficacy and safety of different treatment regimens of vilaprisan in subjects with~     uterine fibroids~   "
24944|NCT03240510|"~     The goal of this study is to evaluate the Salah Azaïz Cancer Institute male breast cancer~     patients population over a period of 14 years.~      Goal of the retrospective part: to gather clinicopathologic data and follow-up outcomes of~     male breast cancer patients diagnosed and/or treated at Salah Azaïz Cancer Institute from~     2004 to 2013.~      Goal of the prospective part: to create a registry of male patients with breast cancer for a~     period of 48 months (from 2014 to 2017).~   "
24945|NCT03240497|"~     Inflammatory cytokines play a pivotal role in rheumatoid arthritis (RA) and innovative~     non-pharmacological therapies aimed at limiting cytokine production are highly warranted.~     Recently, our group showed that healthy volunteers trained in an intervention developed by~     'Iceman' Wim Hof were able to voluntarily attenuate the pro-inflammatory response during~     experimental human endotoxemia (a model of systemic inflammation elicited by administration~     of lipopolysaccharide [LPS] in healthy volunteers). Subjects trained in the intervention~     exhibited profound increases in plasma adrenaline levels, a rapid increase of an~     anti-inflammatory cytokine and subsequent attenuation of the pro-inflammatory response.~      The intervention consists of three elements, namely meditation, exposure to cold and~     breathing techniques. The meditation element is not likely to be involved. It was a very~     minor part of the training program and was not practiced during the endotoxemia experiments.~     Exposure to cold and the subsequent rewarming to normal body temperature may influence the~     inflammatory response through the release of immunomodulatory molecules like HSP-70. Also,~     exposure to cold can induce an ischemia-reperfusion-like state in the skin and peripheral~     tissue that is known to be involved in the downregulation of pro-inflammatory cytokines and~     upregulation of anti-inflammatory cytokines. The investigators anticipate that the third~     element, breathing techniques, is the major contributor to the anti-inflammatory effects of~     the intervention previously observed. The present study aims to explore the effects of the~     breathing technique ('strength ventilation'), the exposure to cold, and these two elements~     combined on the immune response during human endotoxemia. Elucidation of the relative~     contribution of the elements is of importance to establish a feasible, safe, and effective~     intervention for future use in patients.~      Objective: The primary objective of the present study is to determine the effects of the~     `strength ventilation` breathing technique and exposure to cold, both separately and in~     combination, on the inflammatory response during human endotoxemia. To this end, a 2 by 2~     design will be employed. Additionally, an evaluation of the influence of the cold exposure~     and breathing technique on pain thresholds and oxygen tension in the mitochondria will take~     place.~   "
24946|NCT03240484|"~     Long term functional status~   "
24947|NCT03240471|"~     Distal radius fracture (DRF) is a common fracture of which the incidence appears to be~     increasing worldwide. On average, a total of 17% of all diagnosed fractures are DRF's.~      In the Dutch guideline for DRF the treatment advice for DRF, without reduction, is treatment~     with plaster cast or brace for one-three weeks. Despite the advice in the guideline and~     despite several studies from the 90's showing that plaster cast treatment of a stable DRF for~     one week is safe, the usual length of plaster cast treatment for stable DRF is four-six~     weeks. In addition, recent studies have also shown that a long period of immobilization can~     lead to more post traumatic pain by increasing disuse and kinesiophobia.~      This evidence suggests that the usual duration (4-6 weeks) of plaster cast treatment for DRF~     is unnecessary.~      The aim of this feasibility study is to define whether one week of plaster cast treatment is~     possible and can lead to better functional results, with at least the same patient~     satisfaction and complications. In addition, this feasibility study will be used to define~     the sample size of the future RCT.~   "
24948|NCT03240458|"~     Diabetic macular edema is one of the major causes of visual impairment in diabetic~     retinopathy patients especially in the working age group. The problem is likely to increase~     in the future with statistics showing a growing number of the diabetic population especially~     in the Middle East . .~   "
24949|NCT03240445|"~     This Phase I study in healthy male volunteers will evaluate the impact of the effect of food~     on the pharmacokinetic profile of ODM-203.~   "
24950|NCT03240432|"~     The primary objective of the study is to determine if CGM can reduce hypoglycemia and improve~     quality of life in older adults with T1D.~   "
24951|NCT03240419|"~     This study will assess the feasibility of a randomized control trial in which the effects of~     probiotic supplementation throughout pregnancy on maternal insulin sensitivity and~     inflammation, as well offspring gene expression and body composition are examined.~   "
24954|NCT03240380|"~     This randomized clinical trial compares the influence of joint crisis plans (JCP) or crisis~     cards to reduce psychiatric coercion for people with severe and often recurring mental~     illnesses like schizophrenia, bipolar disorder or schizoaffective disorder. Both~     interventions will be carried out as an integrated part of otherwise standard psychiatric~     in-patient and out-patient care in psychiatric units specializing in the acute or non-acute~     treatment of mentioned mental illnesses.~   "
24955|NCT03240367|"~     Introduction RYGB surgeon; Have become increasingly morbid obesity treatment methods with~     improvements in minimally invasive surgery. Ensuring patient comfort and early return to life~     are the criteria that should be given priority in this treatment method.The purpose of this~     study; Emphasizing that the cautery technique of the stapler line bleeding control methods is~     as successful as the other methods.~   "
24956|NCT03240354|"~     In paediatric anaesthesia, use of cuffed endotracheal (ET) tubes is subject to much debate.~     The concern is the possibility of damage to tracheal mucosa by excessive pressure from the~     cuff. The cuff pressure can increase during anaesthesia, especially if nitrous oxide is used.~      Using saline to inflate the cuff has been shown to reduce intra-operative cuff pressure~     variation in adult studies, although it is not standard practice. Although the literature~     contains reports of cuff pressure increases during paediatric anaesthesia, there are no~     reports of attempts to address this. Use of pressure monitoring is recommended by AAGBI, but~     may not be consistently done. A safe method of limiting pressure, that is effective, imposes~     minimal extra workload and has minimal cost, would reduce risk to patients.~      This study aims to investigate the effect on intra-operative cuff pressure of using saline to~     inflate the ET tube cuff, compared to standard practice of air inflation. Continuous pressure~     monitoring will be used to determine the proportion of cases where interventions are required~     to keep the pressure below a safe maximum level.~   "
24957|NCT03240341|"~     The aim is to implement the Patient Activation Measure in paramedical practices as a tool to~     measure activation of patients in cancer care~   "
24958|NCT03240328|"~     To study the safety and effectiveness of CAR-T Cell Therapy on HIV patients whose plasma HIV~     has been successfully suppressed after cART, which is expected to enhance the~     res-constitution of HIV-specific immune function to assist the eradication of HIV reservoir.~   "
24959|NCT03240315|"~     This is a 3 year longitudinal study to establish a personalized prediction and prevention~     system for acute exacerbation of chronic obstructive pulmonary disease（AECOPD). Data will be~     collected which contained with clinical, pathophysiology, etiology and immunology information~     of chronic obstructive pulmonary disease(COPD) patients and analyzed by data mining combined~     with Internet technology.~   "
24960|NCT03240302|"~     The aim of this research is to compare sibling oocytes using two sperm selection methods for~     choosing the best quality spermatozoa before they are injected into oocytes and the influence~     of each of these methods on embryo quality and IVF outcome.~   "
24961|NCT03240289|"~     Diabetes during pregnancy can be a challenging circumstance requiring extensive patient~     learning and self-care. The purpose of this study is to develop and pilot test a~     patient-centered diabetes education and self-care tool using text messaging to provide~     supportive messaging and education to underserved women with a pregnancy complicated by~     diabetes.~   "
24962|NCT03240276|"~     The aim of this research is to compare sibling oocytes using two sperm selection methods for~     choosing the best quality spermatozoa before they are injected into oocytes and the influence~     of each of these methods on embryo quality and IVF outcome.~   "
24963|NCT03240263|"~     Failure to wean is a clinical problem and strength training of inspiratory muscles has been~     recently proposed as possible additional component of weaning strategies. The main hypothesis~     is that inspiratory muscle training improve weaning success rates and abbreviate weaning~     duration and ICU length of stay in difficult to wean patients compared to a sham endurance~     training group.~   "
24964|NCT03240250|"~     For the treatment of stage I-II NSCLC, two mini-invasive techniques are mostly utilized:~     uni-portal and three-portal VATS. In the uniportal approach, the injury on a single~     intercostal space could determine a lower level of pain than the three-portal approach,~     allowing a better postoperative course. Few studies in Literature compare these techniques,~     and most of them are retrospective.~      The main purpose of this randomized study is to compare uni-portal VATS with three-portal~     VATS, in terms of postoperative pain.~      Secondary objectives of the study are valutations of:~        -  respiratory and functional capacity between the two groups~        -  operative time~        -  number of resected lymphnodes~        -  intra and postoperative complications, such as conversions to open surgery, amount of~          bleeding, prolonged air leaks, surgical site infections, pulmonary complications.~   "
24965|NCT03240237|"~     This pilot study will evaluate the efficacy and safety of CCM therapy in heart failure~     patients with baseline EF≥50% (HFpEF) who have New York Heart Association (NYHA) Class II or~     III symptoms despite appropriate medication.~      The terminology of the HF classification HFpEF is based on the 2016 European Society of~     Cardiology (ESC) Heart Failure Guidelines.~   "
24966|NCT03240224|"~     The aim of this study is the synergistic effect of cancer ablation and life information~     rehabilitation therapy on unresectable breast cancer.~   "
24967|NCT03240211|"~     This is a multicenter, multi-arm, international, phase Ib, 3 x 3 dose-escalation study with~     an initial phase I followed by an expansion phase. The primary objective of the phase Ib is~     to determine the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), and dose~     limiting toxicity (DLT) of various combinations of pembrolizumab, pralatrexate and~     decitabine.~   "
24980|NCT03240042|"~     When the retractor blades oped and is positioned to provide the surgical access in the~     anterior cervical spine surgery, it cause the trachea to deviate laterally and pose pressure~     on the tissue between the retractor and the trachea. This is convincible as revealed by the~     increase of cuff pressure of endotracheal tube. The study aims to investigate differences in~     the increase of cuff pressure after retractor is positioned between nasotracheal and~     orotracheal intubation.~   "
25400|NCT03234491|"~     The study will be conducted in two phases; an in-patient meal study phase (Phase I) and an~     outpatient home study (Phase II). The two phase study design is chosen to enhance safety by~     testing the Afrezza Closed-Loop (CL) system in controlled in-clinic setting under study staff~     supervision before it could be investigated at the outpatient home setting. Phase II will not~     begin without the establishment of safety in Phase I.~   "
24968|NCT03240198|"~     Chronic obstructive pulmonary disease (COPD) is a frequent disease, mainly linked to tobacco~     smoking leading to chronic respiratory failure. It is characterized by an inflammatory spate~     with modification of protease-antiprotease and oxidant-antioxydant balances. Local~     modifications are associated with systemic changes. Many occupational factors have been~     associated with an excess of COPD in epidemiological studies, however without identification~     of any specific clinical or biological phenotype.~      Pathophysiological pathways involved in COPD might be different according to etiologic~     agents. Therefore, it is important to focus research on blood biomarkers associated with some~     well-characterized occupational COPD.~      The objectives of MB2PROF project are:~        1. To build the first multicentric cohort of cases of occupational COPD, with collection of~          plasma and DNA samples,~        2. To study the evolution of clinical and lung function parameters of occupational COPD in~          comparison with non occupational COPD during a follow-up study,~        3. To identify biological phenotypes of COPD associated to a given etiological agent.~      The methodology includes:~        1. The constitution of a cohort with a clinical and biological follow-up during 5 years.~          Subjects will be recruited in 7 occupational diseases departments, with the~          collaboration of Pneumology departments.~           Four groups of males subjects will be recruited (G1 : occupational COPD (6 groups of 60~          subjects, corresponding to 6 groups of occupational agents) ; G2 : non occupational COPD~          (n = 60) ; G3 : subjects with similar occupational exposure to G1 subjects but without~          COPD (6 groups of 60 subjects) ; G4 : subjects free of occupational exposure and of COPD~          (n = 60)), paired on tobacco-smoking and age. For each subject, information on clinical~          data, lung function parameters, occupation history and blood samples will be collected.~        2. The identification of biomarkers, using proteomic and genomic approaches according to~          subgroups (with different etiologies) of occupational COPD,~        3. The study of molecular pathways identified in these subgroups, with in vitro and in vivo~          studies The MB2PROF project is an original and ambitious multidisciplinary and~          translational project. The constitution of well-characterized COPD cases cohort should~          allow the identification of biomarkers and molecular pathways associated with some~          subgroup of subjects, and improve the knowledge of mechanisms involved.~   "
24969|NCT03240185|"~     This is a quality assurance trial to evaluate the effectiveness of guided breathing exercises~     on reducing the symptoms of hemorrhoidal disease in colorectal surgery patients. All patients~     who undergo hemorrhoid surgery are educated on breathing exercises that can be used to reduce~     pain and increase relaxation. These patients will be surveyed at their post-operative visit~     regarding pain and other symptoms and at their one month post operative visit on the any~     hospitalizations and emergency room visits since their surgery.~   "
24970|NCT03240172|"~     detection of DNA damage due to occupational exposure to low dose ionizing radiation using~     comet assay technique and genotyping of certain DNA repair genes to detect inherited~     polymorphism.~   "
24971|NCT03240159|"~     A prospective study of three different doses of Degarelix in late luteal phase of women~     undergoing ovarian stimulation for IVF~   "
24972|NCT03240146|"~     The ActiPatch is a cutaneous device which is CE marked approved for relief of pain and has~     FDA clearance as an over the counter device for the adjunctive treatment of osteoarthritis of~     the knee and plantar fasciitis. It is taped over the affected area and stimulation at a high~     frequency is reported to alleviate pain with no sensation. By randomising patients between~     application of an active device or a dummy device and assessment of disability and pain~     scores at four weeks the efficacy or otherwise can be established. Chronic low back pain is a~     major health problem and if effective this has major economic implications as the device is~     cheap and safe.~   "
24973|NCT03240133|"~     This 3-part study will evaluate the efficacy and safety of an oral kallikrein inhibitor,~     BCX7353, in the treatment angioedema attacks in subjects with Type I or II hereditary~     angioedema (HAE). In each study part, subjects will treat 3 attacks with BCX7353 (2 attacks)~     or placebo (1 attack), in a randomly allocated order. In Part 1, the dose of 750mg will be~     assessed relative to placebo in up to 36 patients. If this is shown to be effective, then a~     further 12 patients will be enrolled at a 500mg dose (Part 1), followed by a further 12 (if~     efficacy still shown) at a dose of 250mg (Part 3) to determine the minimum effective dose of~     BCX7353 compared to placebo for treating HAE attacks. Efficacy will be determined by subject~     diary entries completed at pre-defined times post-dose.~   "
24974|NCT03240120|"~     This trial aims at determining if dabigatran is effective in the treatment of malignancy~     associated VTE. Tolerance and safety of dabigatran will also be assessed.~      This is a single armed trial of dabigatran in patients with malignancy associated VTE.~      The target recruitment is 99 consecutive patients with active malignancy and newly diagnosed~     VTE (deep vein thrombosis and/or pulmonary embolism) in Queen Mary Hospital.~      Tinzaparin 175 iu/kg daily will be started after the diagnosis of VTE is confirmed (duplex~     Doppler ultrasonography for deep vein thrombosis, and computed tomography for pulmonary~     embolism), and a written consent is obtained. Patients will be switched to dabigatran 150mg~     twice daily from day 6 onwards. The first dose of dabigatran will be given within 2 hours~     before the time that the next dose of tinzaparin would have been due. Anticoagulation will be~     continued as long as malignancy is active. If patients achieve a complete remission of their~     underlying malignancies, dabigatran will be continued for 6 months further.~   "
24975|NCT03240107|"~     to evaluate the surgical effect of levator aponeurosis resection Versus two point fixation~     levator aponeurosis Tucking for Congenital Ptosis~   "
24976|NCT03240094|"~     An optimal nutritional status is essential for healthy ageing. Telemonitoring might~     contribute to maintaining or improving nutritional status in elderly people.The objectives of~     this effect study are to test the feasibility and effectiveness of telemonitoring of~     nutritional parameters in community-dwelling older adults.~   "
24977|NCT03240081|"~     The purpose of this study is to compare the effectiveness of two low doses of estrogen cream~     applied to a new location for the treatment of moderate or severe pain during sexual~     intercourse in postmenopausal women.~   "
24978|NCT03240068|"~     Peripheral arterial disease (PAD) affects over 8 million individuals in the United States~     alone. This is a form of atherosclerosis in which plaques preferentially build up inside the~     arteries of the legs to limit blood flow. These patients are at high risk for heart attack~     and stroke, with at least half dying from coronary artery disease. Our understanding of the~     causes of PAD remains incomplete. The renin-angiotensin hormone system is one mechanism known~     to contribute to atherosclerosis. Pharmacologic blockade of the hormone angiotensin II is~     beneficial in forms of atherosclerosis, including peripheral arterial disease, to improve~     blood vessel damage and functional outcomes. These therapies also increase circulating levels~     of angiotensin-(1-7), a hormone that dilates blood vessels. Angiotensin-(1-7) improves blood~     vessel function and reduces inflammation to protect against atherosclerosis in animal models;~     however, there are no clinical data in patients with atherosclerosis. The overall goal of~     this project is to examine the cardiovascular effects of angiotensin-(1-7) in PAD.~   "
24979|NCT03240055|"~     The purpose of this study is to investigate the effect of spinal anesthesia on ED50 and BIS50~     of etomidate for the loss of consciousness (LOC) by using up-and-down method.The hypothesis~     was that spinal anesthesia could significantly reduce the etomidate bolus dose for the LOC~     and could also achieve hemodynamic stability during anesthesia induction.~   "
24981|NCT03240029|"~     Few data about the evaluation of consequences of past life with cancer on life quality of~     children in school reintegration are available in literature. Nevertheless, some of these~     studies show that the reintegration impairs life quality of these children (school~     difficulties, conflictual relations with peers…). The hypothesis is that children with past~     life with cancer have more chances to have school integration difficulties with a consequent~     life quality degradation compared to healthy children.~      The main objective of this project is to study the relation between the satisfaction of~     school reintegration of children in cancer remission and the evolution of life quality in the~     medium term (after getting back to school). More exactly, it is the question if the~     satisfaction of school reintegration influences life goals and priorities of these children.~      The secondary objective is to study the role of psychological status of these children~     (anxiety, depressive symptoms) on satisfaction-life quality relation.~      A group of children with cancer history sent to ordinary school is compared to a control~     group of children sent to school in the same conditions (sex and age matched). Data are~     collected with questionnaires some months to several years after school reintegration and~     same questionnaires 1 year later.~      If the study hypothesis is confirmed, this study will show the necessity of a long term~     follow up of children in cancer remission and not only medical care, but also psychological~     and social care, in order to support a better school reintegration.~   "
24982|NCT03240016|"~     This is a phase 2, single arm, two-stage study of abraxane with an anti-PD1/PDL1~     (pembrolizumab) in cisplatin-ineligible patients with advanced urothelial cancer.~      Each cycle last 21-days. All subjects will receive abraxane via IV on Day 1 and Day 8 of each~     cycle. Subjects will either receive pembrolizumab (IV) on Day 1 of each cycle. Subjects may~     continue to receive the study regimen until they experience disease progression or~     unacceptable toxicity.~   "
24983|NCT03240003|"~     The present study is a double blind trial that seeks to examine the feasibility,~     acceptability, efficacy, and mechanism of a recently developed eye-tracking-based therapy~     (GC-MRT) in individuals with social anxiety disorder (SAD)~   "
24984|NCT03239990|"~     According to studies, approximately 20% of children having contact with child protection~     services have conduct disorder. Negative parenting can make this problem even worse. Research~     has shown Incredible Years Program to be one of the most effective programs to prevent and~     reduce child conduct problems. This study is an randomized controlled trial, which evaluates~     the suitability and effectiveness of group-based Incredible Years program in child protection~     and family support services. The aim of this study is to find out whether this intervention~     reduces children's psychiatric symptoms, especially conduct symptoms, increases positive~     parenting and positive interaction between parents and children, and reduces children's and~     parent's stress and increase well-being. The study will be carried out in 2015-2018. Overall~     101 children and 120 parents participate in the study.~   "
24985|NCT03239977|"~     This study is a randomized clinical trial designed to compare an online social intelligence~     intervention with an active control condition at improving the emotional, physical, and~     social well-being of custodial grandmothers and their adolescent grandchildren,~   "
24986|NCT03239964|"~     Two groups of patients (73 patients each) undergoing routine caesarean section has recurrent~     keloid at site of surgical scar. One group will undergo surgical excision of keloid. The~     other group will have combined surgical excision of keloid and single intralesional~     dexamethasone injection at edges of wound.All patients were reviewed once per month for 6~     months for evidence of recurrence~   "
24987|NCT03239951|"~     Subjects with AUR secondary to BPO that comply with Inclusion/Exclusion Criteria.~      A total of 44 eligible subjects will be randomized into the study to receive treatment with~     either re-catheterization OR with iTind implantation using a 1:1 randomization scheme~     stratified by center.~      Study duration will be 12 months post implantation, with follow-up extension of up to 3~     years. Extension of follow up period will not require an additional ICF.~   "
24988|NCT03239938|"~     Modern pain neuroscience has advanced our understanding of chronic whiplash associated~     disorders (WAD). Previous studies have shown the importance of central sensitization,~     characterized by hypersensitivity of the somatosensory system, in explaining poor treatment~     outcome. Therefore, and to address the need for a better treatment of chronic WAD, we~     recently proposed a modern neuroscience approach to chronic WAD. Such approach includes two~     specific parts: therapeutic pain neuroscience education followed by dynamic and functional~     cognition-targeted exercise therapy and stress management techniques.~      The primary scientific objective of the study entails examining the effectiveness of a modern~     neuroscience approach versus usual care evidence-based physiotherapy for reducing~     dysfunctioning in patients with chronic WAD. The secondary scientific objective of the study~     entails examining the effectiveness of a modern neuroscience approach versus usual care~     evidence-based physiotherapy for reducing pain, central sensitization, psychosocial problems,~     and socio-economic burden in patients with chronic WAD. The trial will randomize 120 patients~     with chronic WAD, aged between 18 and 65 years, to the experimental (modern pain neuroscience~     approach including 3 sessions of therapeutic pain neuroscience education followed by 15~     sessions of dynamic and functional cognition-targeted exercise therapy and stress management~     techniques (n = 60)) or the control treatment (usual care physiotherapy including 3 sessions~     of neck school followed by 15 sessions of graded and active exercise therapy focusing on~     strength, flexibility, endurance, and ergonomic principles (n= 60)). The primary outcome~     measure is self-reported functional status. Secondary outcome measures include pain,~     health-related quality of life, psychological correlates, measures of central sensitization,~     and socio-economic factors. In addition, quantitative scalp Electroencephalography (EEG) to~     measure various parameters of brain activation will be performed during a conditioned pain~     modulation paradigm. Baseline assessment of all outcome measures will be performed.~      Follow-up assessments will be performed immediately after 16 weeks of therapy (all tests),~     and 6 months (all tests) and 12 months (only questionnaires) after finishing the therapeutic~     intervention.~      To investigate these objectives, a multi-center triple-blind randomized, controlled trial~     with 1 year follow up will be performed.~   "
24989|NCT03239925|"~     To investigate the acute effects of cell phone exposure on immediate attention levels and~     concentration of emergency department physicians~   "
24990|NCT03239912|"~     This experimental study will evaluate the effect of combined treatment with low-level laser~     and functional appliances (twin-block) on the correction of Class II malocclusion, compared~     with the control group treated with functional appliances (twin-block) only.~      The study sample will consist of 40 patients with Class II malocclusion. The sample will be~     allocated randomly into two groups: a control group and an experimental group.~      Functional appliance (twin-block) will be applied for all patients. Low-level laser will be~     applied for the experimental group only. The skeleto-dental changes occurring after~     functional treatment will be assessed using cephalometric radiographs; pre- and post-~     treatment changes for each group will be evaluated individually.~   "
25033|NCT03239340|"~     A multicentre, open-label, single-arm, molecular profiling study of patients with EGFR~     mutation-positive locally advanced or metastatic NSCLC treated with osimertinib~   "
28984|NCT03187613|"~     Individuals operated for rhegmatogenous retinal detachment will be prospectively evaluated~     for postoperative retinal shift. Fundus autofluorescence will be used to evaluate retinal~     shift that will be correlated to visual acuity, metamorphopsia, aniseikonia, and stereopsis.~   "
24991|NCT03239899|"~     Background:~      HIV affects millions of people. The disease may hide in the brain, even in people with~     well-controlled HIV without cancer. Then it may wake up and continue. The drug~     pembrolizumab uses the body s immune system to fight cells like cancer cells. It is approved~     to treat some cancers but not HIV. Researchers want to see if it is safe for HIV-positive~     people without cancer. This study is not for HIV treatment; only one dose of the drug will be~     used.~      Objective:~      To learn if the drug pembrolizumab, used to treat certain cancers, is safe for HIV-positive~     people.~      Eligibility:~      Adults ages 18 and older with HIV who are in another NIH protocol~      Design:~      Participants will be screened with:~        -  Medical history~        -  Physical and neurological exams~        -  Blood tests~        -  Lumbar puncture. The lower back will be numbed. A needle will remove fluid from between~          back bones.~        -  FDG-PET/CT. A radioactive sugar will be injected in a thin plastic tube (catheter)~          inserted in an arm vein. Participants will rest for an hour, urinate, then lie in the~          scanner. A mask will hold the head still.~      Women who can become pregnant cannot take pembrolizumab. Men who take it must use 2 kinds of~     contraception.~      Participants will have up to 7 more visits, which repeat some screening tests.~      At 1 visit, participants will get one dose of pembrolizumab by catheter for 30 minutes. They~     will get allergy and pain medicines.~      At 2 visits, participants will have a brain MRI. They will get a contrast agent by catheter.~     They will lie in a metal cylinder that takes pictures for 1-2 hours. They will get earplugs~     for loud sounds.~   "
24992|NCT03239886|"~     This study will evaluate the proportion of subjects with chronic myeloid leukemia chronic~     phase that sustain major molecular response after imatinib discontinuation. To be eligible~     for this protocol, the subject must have received imatinib as first line regiment for at~     least 3 years with sustained molecular response of 4log (RM4log) or higher for one year.~   "
24993|NCT03239873|"~     This study will evaluate the immunogenicity, safety, and tolerability of VARIVAX™ (Varicella~     Virus Vaccine Live) manufactured with a new passage extension (PE34) process compared with~     the VARIVAX™ 2016 commercial process. The primary hypotheses being tested are that antibody~     response rate and mean antibody titer induced at 6 weeks after a single vaccination by~     VARIVAX™ PE34 Process are non-inferior to those induced by VARIVAX™ 2016 commercial process,~     and that antibody response rate induced by VARIVAX™ PE34 Process is acceptable.~   "
24994|NCT03239860|"~     The humanised IgG4 monoclonal antibody GNbAC1 targets the envelope protein (Env) of the human~     endogenous multiple sclerosis-associated retrovirus (HERV-W MSRV), which may play a critical~     role in multiple sclerosis.~      The study assesses the long-term safety of GNbAC1 in patients with RRMS and the long-term~     efficacy of GNbAC1 in terms of MRI outcomes, relapse rate, disability and disease~     progression.~   "
24995|NCT03239847|"~     This study aims to compare the time difference between radial arterial line placement and use~     of the EndoPhys sheath, as well as, assess the cost effectiveness of the EnoPhys sheath vs.~     use of a radial arterial line based on device and operating room costs.~   "
24996|NCT03239834|"~     Objectives Validate the OncAlert RAPID Test, with an NPV ≥(1-prevalence).~      Evaluate the independent and associated contribution of readily available clinical variables~     including age, race, gender, HPV status, socioeconomic level, tobacco, and alcohol use with~     the biopsy and test results.~      Evaluate OncAlert RAPID Test results in patients without immediate biopsy, both at baseline~     and scheduled follow-up visit (approximately 1-3 months), to assess impact on outcome.~      Planned Number of Subjects 800 patients will be followed until pathology of clinically~     directed incisional / diagnostic biopsy pathology report is received.~      An additional 200 'non-biopsy subjects' will be followed then re-evaluated during a 1-3 month~     clinic visit.~      Additional follow up of subject data may continue for up to 2 years. Patient Population~      Cohorts 1a and 1b:~      Subjects with a clinical suspicion of oral potentially malignant disorders, oral or~     oropharyngeal cancer, or both based in part on clinical examination, symptoms, clinical~     history, suspicious lesion(s) in mouth without history of a prior biopsy.~        -  Cohort 1a: oral cavity~        -  Cohort 1b: oropharynx~      Cohort 2:~      Subjects with clinically indicated suspicion of disease but without immediate biopsy, both at~     baseline and scheduled follow-up visit (approximately 1-3 months), Screen Fail Rate A 20%~     Screen Fail Rate is anticipated. Investigational Product Name OncAlert Oral Cancer RAPID Test~     (OncAlert RAPID) Methodology Overview Prospectively collect 5cc of normal saline after a~     combination of swish, gargle and spit into the provided collection specimen cup. Specimens~     will be collected at baseline (time of biopsy) as per standard practice at each site. The~     OncAlert RAPID Test cassette is inserted into the specimen cup and read directly from the~     cassette in 10 minutes. In addition, comprehensive clinical - pathology and patient~     demographic features including age, gender, race, ethnicity, and all pathology biopsy results~     will be collected. Any pertinent additional clinical data including HPV status, socioeconomic~     status, smoking, drinking history, and pertinent features related to oral health will be~     obtained. A central pathology review for all biopsy results will be performed and~     incorporated into the final analyses.~   "
24997|NCT03239821|"~     The primary aim of this investigation is to assess the safety, feasibility and performance of~     the VIPUN Balloon Catheter 0.1 in the assessment of gastric motility. The investigation will~     also assess whether the inflation of the VIPUN Balloon Catheter can stimulate gastric~     motility and emptying. Furthermore, this investigation will examine whether gastric motility~     and emptying as measured in this study are correlated.~   "
24998|NCT03239808|"~     Background: Incremental hemodialysis (HD) is a starting regime for renal replacement therapy~     (RRT) adapted to each patient's necessities. It is mainly conditioned by the residual renal~     function (RRF). The frequency of sessions with which patients start HD -one or two sessions~     per week-, is lower than that for conventional HD three times per week. Such frequency is~     increased (from one to two sessions, and from two to three sessions) as the RRF declines.~      Methods/Design: IHDIP is a multicenter randomized experimental open trial. It is randomized~     in a 1:1 ratio and controlled through usual clinical practice, with a low intervention level~     and non-commercial. It includes 152 patients older than 18 years with chronic renal disease~     stage 5 and start HD as RRT, with a RRF of ≥ 4ml/min/1.73m2, measured by renal clearance of~     urea (KrU). The intervention group includes 76 patients who will start with one session of HD~     per week (incremental HD). The control group includes 76 patients who will start with three~     sessions per week (conventional HD). The primary purpose is assessing the survival rate,~     while the secondary purposes are the morbidity rate (hospital admissions), the clinical~     parameters, the quality of life and the efficiency.~      Discussion: This study will enable us to know with the highest level of scientific evidence,~     the number of sessions a patient should receive when starting the HD treatment, depending on~     his/her RRF.~   "
25081|NCT03238716|"~     The purpose of this research is to compare two different approaches for treating patients~     with stress urinary incontinence: neuromuscular re-education, impairment-based exercise and~     electric dry needling versus neuromuscular re-education and impairment-based exercise.~     Physical therapists commonly use all of these techniques to treat stress urinary~     incontinence. This study is attempting to find out if one treatment strategy is more~     effective than the other.~   "
24999|NCT03239795|"~     Most of family physicians (FPs) use advertising in their waiting rooms in order to educate~     patients. Our objective was to assess an advertising campaign for influenza vaccination using~     posters and pamphlets in FPs' waiting rooms.~      Registry based 2/1 cluster randomized controlled trial. Clusters gathered the listed patients~     over the age of 16 of 75 randomized FPs. The trial was conducted during the 2014-2015~     influenza vaccination campaign. Intervention group, 25 FPs received and exposed in their~     waiting rooms pamphlets and one poster promoting the influenza vaccination campaign (added to~     the usual mandatory information). Control group (50 FPs), usual waiting room. The main~     outcome was the number of vaccination units delivered in pharmacies. Data were first~     extracted for 2013-2015 from the SIAM-ERASME claim database of the Health Insurance Fund of~     Lille-Douai (Northern France). The association between the intervention and the main outcome~     was assessed trough a generalized estimating equation.~   "
25000|NCT03239782|"~     The prevalence of overweight and obesity in Singapore is approximately half of that in the~     United States, yet the incidence of type 2 diabetes is similar, and is expected to double in~     the near future. This indicates that metabolic dysfunction, particularly insulin resistance,~     is widely prevalent even among individuals who are considered normal-weight or lean by~     conventional measures, i.e. body mass index (BMI) and percent body fat. These individuals are~     often referred to as metabolically-obese normal-weight (MONW), and have increased risk for~     cardiometabolic disease despite their normal BMI and total body fat values. The prevalence of~     the MONW phenotype varies across populations and differs markedly among different~     ethnicities. However, our understanding of the complex interactions between ethnicity, body~     composition, and metabolic dysfunction and its reversal remains rudimentary. Previous~     attempts to characterize the MONW phenotype are confounded by the small but significant~     differences in BMI or percent body fat between groups (even if all subjects were lean, within~     the normal range), with MONW subjects being always fatter than the corresponding control~     subjects. There are no published studies that prospectively recruited groups of metabolically~     healthy and unhealthy lean individuals matched on BMI and percent body fat. Furthermore,~     although weight loss improves body composition and many of the cardiometabolic abnormalities~     in most obese patients, little is known about the possible therapeutic effects of calorie~     restriction in MONW subjects.~      Accordingly, a better understanding of the MONW phenotype and the evaluation of therapeutic~     approaches for its reversal will have important implications for public health. By~     facilitating earlier identification of these subjects, who are more likely to go undiagnosed~     and thus less likely to be treated before clinically overt cardiometabolic disease develops,~     results from this study will allow for earlier and effective intervention.~   "
25001|NCT03239769|"~     One hundred twenty female patients who underwent thyroidectomy were evenly distributed into~     three groups: conventional access (CA), aesthetic principles access (APA) and minimally~     invasive access (MIA). The Patient and Observer Scar Assessment Scale (POSAS) was used as the~     assessment tool for the linear scar. After one year follow-up, the cosmetic outcomes were~     assessed.~   "
25002|NCT03239756|"~     This is a single-center, open-label, dose-escalating study to evaluate the safety,~     pharmacokinetics, immunogenicity, and preliminary efficacy of single and multiple~     subcutaneous injection TK006 in patients with breast cancer-related bone metastases.~   "
25003|NCT03239743|"~     Pain and anxiety have a direct correlation. Patients who experience anxiety are more~     susceptible to feeling pain, and patients who experience pain are more likely to have a~     component of anxiety associated with their pain. A common technique used by pain~     psychologists to help minimize pain is distraction. Different forms of distraction include~     video games, movies, music, etc. Recently, doctors and researchers around the world have~     begun experimenting with Virtual Reality as a distraction technique.~      A review of the use of virtual reality compared to the current standard of care may help~     uncover important trends regarding anxiety, postoperative pain and analgesic use in patients~     who undergo a tonsillectomy or a tonsillectomy and adenoidectomy.~   "
25004|NCT03239730|"~     This study evaluates the prognostic value of arterial blood gas analysis in a cohort of~     Emergency Department patients presenting with shortness of breath of any cause, comparing~     obese and non-obese patients.~   "
25005|NCT03239717|"~     Branched-chain amino acids (BCAAs) are essential nutrients that the body obtains from~     proteins found in food, especially meat, diary products, and legumes. Data from rodent~     studies suggest that reduction of dietary BCAAs will promote fat mass loss and improved~     control of blood glucose. The purpose of this study is to test if reduction of dietary BCAAs~     without reducing calorie intake will lead to similar metabolic benefits in humans. Here the~     investigators test the feasibility of reducing dietary BCAAs using BCAA-free meal replacement~     beverages for two months.~   "
25006|NCT03239704|"~     Inflammatory Bowel Diseases (IBD) refers to a category of disorders, consisting of Crohn's~     Disease (CD) and Ulcerative Colitis (UC), where segments of the gastrointestinal tract become~     inflamed and ulcerated. Canada has among the highest incidence rates of IBD in the world -~     16.3 and 12.3 per 100,000 for CD and UC respectively. In the absence of a cure, the current~     goal of treatment is to manage patients in a milder state of remission. However, maintaining~     (or even achieving) remission is dependent on timely access to specialist IBD care; which in~     light of rising incidence rates have proven to be challenging. Moreover, patients often~     experience flare-ups of their gastrointestinal symptoms, while awaiting access to specialist~     care. In recent years, there has been increased integration of telemedicine services in~     gastroenterology practice. This change has been driven by a desire among IBD patients to have~     more flexible follow-up care, where 'virtual' care is provided as an adjunct to in-person~     consultations. Within the context of IBD, telemedicine might be effective in delivering~     routine and timely follow-up care to high-risk patients. The purpose of this study to~     determine whether telemedicine-based follow-up care can effectively manage the~     gastrointestinal symptoms of high-risk IBD patients and reduce their need for preventive~     health care services.~   "
25007|NCT03239691|"~     The main study objective is to assess the effect of ACT-709478 in male and female subjects~     with photosensitive epilepsy following single dose administration~   "
25008|NCT03239678|"~     The use of 100% oxygen during the induction of general anesthesia is always preferable to~     have enough time to secure the airway by endotracheal intubation, because preoxygenation with~     a low oxygen concentration may reduce the safe time for apnea. However, using a low oxygen~     concentration during preoxygenation might prevent the formation of atelectasis. There is~     still no clear conclusion about the best oxygen concentration for preoxygenation. Our study~     is designed to evaluate the safety of preoxygenation with 80%, 60%, 40%, 30% and 21% oxygen~     by the safe time for apnea during the induction of general anesthesia.~   "
25082|NCT03238703|"~     This pilot clinical trial studies how well endocrine therapy works in treating patients with~     HER2 negative, low risk breast cancer. Estrogen can cause the growth of breast cancer cells.~     Endocrine therapies such as aromatase inhibitors and selective estrogen receptor modulators~     may lessen the amount of estrogen made by the body.~   "
25009|NCT03239665|"~     The study consists of two arms (PHARM and PEER) designed to educate participants about three~     vaccine-preventable diseases (zoster, pneumonia, and influenza) and vaccination. PHARM will~     consist of a 60-minute presentation about the three vaccine-preventable diseases and their~     vaccinations delivered by a pharmacist, featuring a didactic lecture and discussion~     supplemented by video clips of community members discussing their experiences around~     vaccination, as well as physicians underscoring the importance of vaccination. PEER will~     consist of a 60-minute small-group session led by a peer educator which includes scripted~     roleplaying exercises designed to reinforce learnings pertaining to these three~     vaccine-preventable diseases and their vaccinations. The components of these interventions~     will be designed to address specific barriers to vaccination identified by literature search~     and our prior work in the area of community-based vaccine education. Both arms will focus~     primarily on pneumococcal disease and zoster but will include limited content on influenza~     because participants are likely to have questions about how the flu and its vaccination~     differ from pneumococcal diseases and zoster. The study will be implemented in an older,~     predominantly African-American (AA) population, consistent with our prior work in this area.~   "
25010|NCT03239652|"~     In this proposal, the investigators plan to conduct a clinical trial to validate the efficacy~     and safety of microspheres (T-ACE Beads).~   "
25011|NCT03239639|"~     Sometimes people with health conditions become ill suddenly and can no longer speak for~     themselves and another person (such as a family member) will make health care decisions for~     them. This means it is important to think about your wishes and tell others about them. This~     is called advance care planning. When people have done advance care planning, if they become~     very sick and cannot speak for themselves they are more likely to get the kind of health care~     they want and it is easier for the people who make decisions for them. There are tools such~     as brochures, questionnaires, and videos that can help people learn about these things. This~     research is being to done to study whether using tools for advance care planning and goals of~     care discussions will improve how patients and their substitute decision makers do advance~     care planning. This study is a randomized trial. This means half of the people in this study~     will meet with someone at their family practice to talk about advance care planning and~     review some tools and half will get usual care (a pamphlet). The study will 1) evaluate if~     reviewing the tools, and having help to complete them, helps patients and their substitute~     decision maker do advance care planning 2) if this intervention will encourage patients to~     talk to their family doctor about these issues.~   "
25012|NCT03239626|"~     To investigate the acute toxicities, late toxicities, and treatment results when the early~     cervical cancer patients are treated by hypofractionated intensity-modulated radiotherapy~     (2.5 Gy X 16 fractions, once a day) after radical hysterectomy.~   "
25013|NCT03239613|"~     To investigate the acute toxicities, late toxicities, and treatment results when the early~     cervical cancer patients are treated by concurrent chemotherapy with hypofractionated~     intensity-modulated radiotherapy (2.5 Gy X 16 fractions, once a day) after radical~     hysterectomy.~   "
25014|NCT03239600|"~     This study aims to evaluate the safety, tolerability and PK of repeat dose administration of~     GSK2618960 in the treatment of pSS. The study will contain two parts, Part I will be open~     label and Part II will be randomized, double-blind. The minimum duration of Part I & Part II~     of the study will be 26 and 32 weeks respectively.~   "
25015|NCT03239587|"~     The goal of this research study is to learn if simulated live piano music can change the~     amount of stress felt in patients with cancer before surgery, health care providers caring~     for cancer patients, and/or hospital volunteers.~      This is an investigational study.~      Up to 304 participants (200 patients, 52 volunteers, and 52 healthcare providers) will be~     enrolled in this study. All will take part at MD Anderson.~   "
25016|NCT03239561|"~     The primary objectives of this study are to characterize [18F]molecular neuroimaging~     (MNI)-1020, a positron emission tomography (PET) radioligand for imaging tau pathology, to~     visually and quantitatively assess and compare brain uptake and pharmacokinetics of~     [18F]MNI-1020 in participants with probable Alzheimer's disease (AD) and compare with age~     matched healthy participants, to evaluate the safety of a single injection of [18F]MNI-1020~     and to compare the distribution of tau (using [18F]MNI-1020) and amyloid beta (using~     florbetapir) in participants with probable AD.~   "
25017|NCT03239548|"~     A Study to assess the Opinion of Doctors, Nurses and Key informants regarding Independent~     Nurse Midwifery Practitioner at selected Hospitals and Colleges of nursing in Haryana.~   "
25018|NCT03239535|"~     The clinical trial aims to study the safety and efficacy of adult allogeneic mesenchymal stem~     cells for the treatment of critical limb ischemia.~   "
25019|NCT03239522|"~     Absorption, metabolism and excretion of daprodustat (GSK1278863) have been studied in~     previous clinical trials; however, the elimination routes and metabolic pathways of~     daprodustat have not been fully elucidated in humans. This is an open-label, single-center,~     non-randomized, 2-period, single-sequence, crossover, mass balance study in 6 healthy male~     participants. The aim of the study is to assess the excretion balance of daprodustat using~     [14C]-radiolabeled drug substance administered orally, and as an intravenous (IV) infusion,~     administered as a microtracer dose (concomitant with an oral, non-radiolabeled dose).~     Absolute bioavailability of an oral dose will also be assessed. Each participant will be~     involved in the study for up to 10 weeks which include a screening visit, two treatment~     periods (treatment periods 1 and 2), separated by about 7 days (at least 14 days between oral~     doses), and a follow up visit 1-2 weeks after the last assessment in treatment period 2. The~     primary objective of the study is to gain a better understanding of the compound's excretory~     and metabolic profile. This study will include sampling of duodenal bile to conduct~     qualitative assessment of drug metabolites in this matrix in order to characterize biliary~     elimination pathways.~   "
25034|NCT03239327|"~     Project summary:~      Objective: To test the hypothesis that administration of vaginal Misoprostol before elective~     cesarean section will improve the neonatal respiratory outcomes in late preterm and early~     term neonates through induction of catecholamine surge.~      Design: Randomized controlled clinical trial. Setting: Women health center ,Assiut university~     hospital. Patients: mothers planned for cesarean section at 34 - 37weeks. Intervention: two~     hundred and ninety two women will be randomly allocated to receive either 50 micrograms of~     Misoprostol per vagina within one hour before cesarean section (study group; n= 146) or~     receive nothing (control group; n = 146) .~      Main outcome measure: Apgar score at 1 and 5 minutes.~   "
25020|NCT03239509|"~     Currently there is an increase in the use of bioprosthesis worldwide (> 70% according to~     national data of the Spanish Society of Thoracic and Cardiovascular Surgery).~      There is conflicting evidence regarding the long-term survival of patients aged 50-65 years~     with mechanical (M) or biological (B) aortic prostheses. General consensus of greater~     complications associated with the use of long-life anticoagulation in M and of reoperation in~     B.~      Similar survival with lower MACCE complications in bioprosthesis could reconsider their~     choice in patients aged 50-65 years, specially in the current TAVI era.~      The investigators are going to perform a multicentric retrospective observational study~     (Registry) about 15 year-outcomes Following Bioprosthetic vs Mechanical Isolated Aortic Valve~     Replacement for Aortic Stenosis in Patients Aged 50 to 65 Years in 5 Cardiovascular Surgery~     Centers in Andalousia (south Spain)~   "
25021|NCT03239496|"~     The study will assess and compare the immune response to full-dose inactivated polio vaccines~     (IPV) via intramuscular (IM) administration and of the fractional dose of inactivated~     poliovirus vaccine (f-IPV) via intradermal (ID) administration, in different schedule~     combinations in the Expanded Program on Immunization (EPI) primary series.~   "
25022|NCT03239483|"~     The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of dapivirine~     gel (0.05%) administered rectally to HIV-1 seronegative adults.~   "
25023|NCT03239470|"~     T cells, a type of white blood cell called a lymphocyte, play an important role in the immune~     system. One subtype, the regulatory T cell (Treg) helps to regulate the immune system and may~     provide protection against the development of autoimmune disease. The hope is that these~     naturally occurring Treg cells can be utilized for the treatment of autoimmune disease and~     potentially replace the use of chronic immunosuppressive therapies that are associated with~     multiple side effects. There has been a small study showing safe administration of Tregs with~     decreased disease activity in patients with insulin-dependent diabetes. Tregs are being~     studied in lupus, cancer and organ transplantation.~      This phase I trial will be conducted as an open-label, dose-escalation, multicenter trial in~     adult participants with active pemphigus.The purpose of this study is to test the safety and~     effect of Treg therapy in participants who have skin (cutaneous) involvement due to~     pemphigus.~   "
25024|NCT03239457|"~     The purpose of this study is to assess the efficacy and safety of the intralesional~     administration of Heberprot-P® (human recombinant epidermal growth factor) plus the standard~     treatment in patients with complex diabetic foot and risk of major amputation in Kuwait.~   "
25025|NCT03239444|"~     This study will evaluate the efficacy of the Foresight Intracardiac Echocardiography system~     ,with improved image quality, in guiding trans-septal punctures during atrial fibrillation~     ablation procedures.~   "
25026|NCT03239431|"~     This is a prospective cohort study that aims to determine the current demographics, clinical~     characteristics, comorbidities, treatment status and exacerbations of asthma patients.~      The primary objective of this study is to determine the current demographics, clinical~     characteristics, comorbidities, treatment status and exacerbations of asthma patients.~      The secondary objectives include: (1) to review the current practices of symptom control~     assessment, (2) to determine the choice of pharmacological regimen, rate of guideline~     adherence and real-world clinical practice in managing asthma patients, (3) to evaluate the~     pattern of lung function parameters (spirometry and forced oscillometry technique [FOT]) in~     adult asthma patients, (4) to evaluate the effect of ageing on the trend of change in lung~     function parameters (spirometry and FOT) in adult asthma patients, (5) to identify biomarkers~     that help to categorize different asthma phenotypes and predict subsequent prognosis, (6) to~     determine the risk factors of uncontrolled asthma and asthma exacerbation, (7) to evaluate~     the impact of comorbidities on asthma control.~      400 out-patient asthma patients are planned to be recruited and they will be followed up for~     3 years.~   "
25027|NCT03239418|"~     Traumatic brain injury, stroke and other neurological conditions may result in weakness of~     the muscles that either open or close the eye. This is generally a result of impaired~     functioning of the oculomotor or facial cranial nerves. Current treatments to improve eye~     opening or closing are either invasive or largely ineffective. This study tests a noninvasive~     means of improving eyelid opening and closing by applying a previously demonstrated safe and~     effective neuromuscular electrical stimulation (NMES) intervention to the muscles controlling~     eyelid movement. Participants in this study will either receive the investigational NMES~     protocol 30 min per day for five days or a sham NMES for the same period. The primary outcome~     for this study is the participants' ability to open or close their affected eye. Secondary~     outcomes include additional measures of eye and corneal health.~   "
25028|NCT03239405|"~     Comparing the operation times and staple loads used between the use of multiple tubes and a~     bougie versus a one-step suction callibrated system in laparoscopic sleeve gastrectomy.~   "
25029|NCT03239392|"~     This study is an open-label, multi-center, dose-ranging study to characterize the safety,~     tolerability, preliminary efficacy, and PK/PD of up to four dose levels of BNZ-1 administered~     weekly by IV infusion to adults diagnosed with Large Granular Lymphocyte (LGL) Leukemia or~     refractory Cutaneous T-cell Lymphoma (CTCL).~   "
25030|NCT03239379|"~     This study is a single-center, randomized, single‑blind, placebo (PBO)-controlled,~     multiple-dose study to characterize the safety, tolerability, PK, and PD of IV BNZ-1~     administered to healthy adult subjects once weekly (QW) for 4 doses or once every other week~     (QOW) for 3 doses. Five cohorts of 6 subjects randomized 5 BNZ-1:1 PBO are planned to be~     enrolled in the trial. Participants will be followed for 4 weeks after the last dose for~     safety monitoring, and collection of PK and PD samples.~   "
25031|NCT03239366|"~     This study will be conducted at the Montreal Heart Institute and should involve 130 Type 2~     diabetes subjects. Subjects will be randomized in a 1:1 ratio to receive either Bio-K+50B®~     probiotic capsules or a matching placebo.~   "
25032|NCT03239353|"~     This is a phase 1, randomized, parallel-group, single-center study in healthy adult subjects.~     The study will be conducted in two parts sequentially:~      Part 1 is an open-label, two-arm, active-controlled design to evaluate the PK and safety of~     single oral dose of ETV XR tablet (1.5 mg) in healthy subjects. Part 1 will consist of 16~     healthy subjects.~      Part 2 is a double-blind, three-arm, placebo-controlled design to evaluate the PK and safety~     of higher oral doses of ETV XR tablet (3 mg and 6 mg) in healthy subjects. Part 2 will~     consist of 24 healthy subjects.~   "
25036|NCT03239301|"~     Study design: Controlled Trial Objective: To evaluate the effectiveness of robotic-assisted~     training of forearm and hand functions in spinal cord injury patients Setting: Ankara~     Physical Medicine and Rehabilitation Training and Research Hospital, Turkey Methods: Forty~     patients were allocated into robotic and control groups. Both groups received conventional~     rehabilitation program for four weeks. Moreover, robotic group received robotic~     rehabilitation program tailored to the patient five times a week (each session of 30 min).~      Baseline data and post-intervention data was compared.~   "
25037|NCT03239288|"~     The objective of this trial is to evaluate the postprandial glucose and insulin responses to~     replacing digestible carbohydrates with resistant starch type 4 (RS4) in a baked product in~     healthy men and women. A randomized, double-blinded cross-over study will be conducted~     comparing two foods (a reference food and a test food). The primary outcome variable will be~     the incremental area under the curve (iAUC) for capillary glucose from pre-product~     consumption (average of t = -15 and -5 min) to 120 min (iAUC0-120 min). This study will~     provide substantiation for a beneficial reduction in glycemic response followed by the~     consumption of the active product containing an efficacious dose of resistant starch type 4~     (RS4).~   "
25038|NCT03239275|"~     The purpose of this study is to compare the effectiveness and efficiency of labial versus~     lingual biocreative therapy in achieving en masse retraction of the maxillary anterior teeth~     in subjects with class II malocclusion requiring upper first premolar extraction.~   "
25039|NCT03239262|"~     The aim of our study was to investigate, whether enhancement of left atrial cryoablation by~     ablation of the autonomic nervous system of left atrium leads to influencing the outcomes of~     surgical treatment of atrial fibrillation in patients with structural heart disease~     undergoing open-heart surgery.~   "
25040|NCT03239249|"~     The aim of this study is to analyze whether and how a systemic school-level approach to~     dropout prevention (the IKO-model), increase the completion rate from upper secondary school.~     The hypothesis is that schools that implement the model (i.e. randomized to the experimental~     group), will reduce the amount of students in risk of dropout, compared to their counterparts~     in schools randomized to the control group. The main expected outcomes in the study are; 1)~     increased amounts of students in upper secondary education completing their education within~     the three-year standard length of education, 2) decreased amounts of school-drop out, and 3)~     reduced values in mediating variables, such as low achievement, course failures, lack of~     attendance and lack of school-motivation and -effort. Accordingly, implementation quality and~     fidelity to the model will be assessed, both with quantitative (survey) and qualitative~     (interviews and observation) data. A total of five counties and 42 upper secondary schools~     participate in the evaluation project. One of the counties (Akershus County) have developed~     and piloted the model and function as a mentor in the other four counties (Oppland, Hedmark,~     Nord-Trøndelag and Hamar). While 20 schools have been randomized to the experimental group,~     22 schools have been randomized to the control group. Schools randomized to the control group~     will work as earlier with school dropout.~   "
25041|NCT03239236|"~     This study investigates the effect of 4 different methods of rapid sequence induction (RSI)~     in morbidly obese patients on the amount of air insufflation into the stomach.~   "
25042|NCT03239223|"~     This study evaluates the use of topical ABI-1968 cream, in the treatment of cervical~     precancerous lesions in adult women.~   "
25043|NCT03239210|"~     This project investigates the use of 4 weeks of 24 mg/day ondansetron as compared to placebo~     on symptoms and brain functioning in patients with obsessive-compulsive disorder (OCD) and~     tic disorders (TD). Patients will be randomized to receive ondansetron or placebo for 4~     weeks, with MRI scans and symptom assessments occurring at baseline (before any drug) and at~     the end of the 4 weeks. Patients will also be asked to come into the lab approximately 2~     weeks into the trial for symptom assessments. The investigators hypothesize that after 4~     weeks there will be greater reduction from baseline in sensory symptoms and the activation of~     the insula and sensorimotor cortex compared for ondansetron as compared to placebo.~   "
25044|NCT03239197|"~     This is an exploratory study designed to collect microbial samples from several body~     locations from 6 pairs of mothers and their newborn infants at various time points.~   "
25045|NCT03239184|"~     The aim of this study is the synergistic effect of cancer ablation and life information~     rehabilitation therapy on unresectable pancreatic cancer.~   "
25046|NCT03239171|"~     The aim of this study is the synergistic effect of cancer ablation and life information~     rehabilitation therapy on unresectable lung cancer.~   "
25047|NCT03239158|"~     The aim of this study is the synergistic effect of cancer ablation and life information~     rehabilitation therapy on unresectable liver cancer.~   "
25048|NCT03239145|"~     This research study is studying an investigational combination of drugs as a possible~     treatment for advanced solid tumors: melanoma, ovarian, renal, or colorectal cancer.~      The drugs involved in this study are:~        -  Pembrolizumab~        -  AMG386~   "
25049|NCT03239132|"~     The purpose of this study is to establish the feasibility and acceptability of a breath-based~     meditation in stroke survivors with post-stroke depression (PSD) and their informal~     caregivers, as well as to examine the effects of the breath-based meditation. The hypothesis~     is that the breath-based meditation will lead to decreases in the severity of symptoms of~     PSD, post-stroke anxiety (PSA), and post-traumatic stress disorder (PTSD), and decreases in~     plasma IL-1 pro-inflammatory cytokines post-intervention in stroke survivors with PSD and~     their informal caregivers.~   "
25050|NCT03239119|"~     This research is a randomized, double-blind,controlled trial. 456 Chinese subjects with Type~     2 Diabetes Mellitus will be enrolled in the trial.~   "
25051|NCT03239106|"~     Chronic Itch is a debilitating condition affecting many people. Currently, there are no~     FDA-approved treatments. Apremilast is an FDA-approved oral medication used to successfully~     treat the inflammatory skin disorder psoriasis and the inflammatory disorder psoriatic~     arthritis. This study examines if apremiliast taken twice daily relieves chronic itch.~   "
25052|NCT03239093|"~     To assess 16-year trends in undernutrition reporting and management in Switzerland~   "
25053|NCT03239080|"~     To evaluate the effects of denosumab on erosion healing and change in physical function in RA~     patients.~   "
25056|NCT03239041|"~     Social determinants of health affect patients throughout the life course. They may be~     particularly relevant for pediatric emergency department (ED) patients. Computerized~     screening for social and behavioral determinants of health has been deemed effective and~     acceptable. This pilot study will characterize the cumulative burden of health related social~     problems experienced by patients and families in a pediatric ED. It will specifically examine~     those patients with a subset of 9 high-risk chief complaints, patients with obesity, patients~     with poor asthma control, and patients with a high number of non-urgent visits, who may be at~     particularly high risk for health related social problems. Our analysis will compare these~     subsets of patients with the general ED population, hypothesizing that these groups will have~     a higher number of health related social problems than the general ED population. Parent and~     adolescent participants will be approached during ED visits and administered a computerized~     screening tool. For patients aged 0-13, a survey administered to parents will test for~     thirteen distinct health related social problems. Two surveys will be administered to~     adolescent-parent dyads. The adolescent survey will test for thirteen health related social~     problems, seven of which overlap with those on the parent survey. The average total number of~     health related social problems in patient groups hypothesized to be at high risk will be~     compared to the average total number of HRSPs in the general ED population. For adolescent~     patients, an intervention group will receive social navigation consisting of rapid referrals~     to community resources based on survey responses by a community health liaison. Their ED~     recidivism, community resource use and number of unmet social needs at 12-month follow up~     will be compared with that of a control group that receives screening and written resources~     only.~   "
25057|NCT03239028|"~     We will examine the association between diet quality in offspring at age 14 years and~     maternal diet quality during pregnancy in the Danish National Birth Cohort~   "
25058|NCT03239015|"~     This study is intended to evaluate efficacy and safety of targeted precision therapy in~     patients with refractory tumor, including rare tumor without standard recommended treatment~     and common tumor after multiple line of therapy.~   "
25059|NCT03239002|"~     This is the first study with a real diagnostic and prognostic focus in prenatal. In addition~     to this innovative aspect, the identification of cryptic imbalances in fetuses with~     malformative syndrome would be an invaluable resource for the identification of new genes~     involved in development, as is already the case for postnatal studies.~      This research aims to:~        1. to test the feasibility of this protocol, ie the practical application of this new~          technology in the context of prenatal diagnosis,~        2. demonstrate and evaluate the possible involvement of cryptic chromosomal abnormalities~          in fetuses with a thick neck associated with other malformations and recruited on the~          strict criteria mentioned above,~        3. assist in the diagnosis of these fetuses and genetic information for their families,~        4. identify new regions of the genome potentially involved in the occurrence of congenital~          malformations.~   "
25060|NCT03238989|"~     The purpose of this study is investigating the clinical course, treatment course, and~     prognosis of patients with interstitial lung disease.~   "
25061|NCT03238976|"~     Patients will be randomly assigned to one of two groups: the group exposed to NS, or the~     standard care group exposed to supportive dialogue. Patients assigned to the former group~     will be exposed to continuous NS throughout the CNB procedure.~   "
25062|NCT03238963|"~     The main objective is to evaluate ocular and systemic safety and tolerability of BI 1467335~     as well as whether BI 1467335 monotherapy has a potential to improve retinal lesions in~     patients with moderately severe Non-proliferative diabetic retinopathy (NPDR) (DRSS level 47)~     or severe Non-proliferative diabetic retinopathy (NPDR) (DRSS level 53), without~     Center-involved diabetic macular edema (CI-DME)~   "
25063|NCT03238950|"~     This study will assess whether the type of simulation model used in cricothyroidotomy~     training has an effect on the subsequent confidence and competence in the procedure.~   "
25064|NCT03238937|"~     The study objectives are to demonstrate the ease and safety of bilateral cervically implanted~     phrenic nerve stimulators for Central Sleep Apnea in patients with Heart Failure. To~     demonstrate the efficacy, both in the short and long term, of implanted phrenic nerve~     stimulators in patients with Central Sleep Apnea and Heart Failure. Central Sleep Apnea is a~     form of hypoventilation syndrome, for which this device is FDA approved. We will also~     determine if the patient's quality and duration of life is improved by using the PNS to treat~     CSA in heart failure patients.~   "
25065|NCT03238924|"~     Posttraumatic stress disorder (PTSD) is a chronic, debilitating anxiety disorder that may~     develop after direct or indirect exposure to traumatic events. Prolonged Exposure (PE) is a~     cognitive-behavioral psychotherapy modality with a wealth of empirical support demonstrating~     its efficacy to treat PTSD in a variety of populations. The neuropeptide oxytocin is a~     promising new pharmacotherapeutic agent with prominent anxiolytic effects . Despite a strong~     biological and theoretical rationale for investigating the potential effectiveness of~     augmenting PE with intranasal oxytocin, no studies to date have done so. The current study~     aims to address this important gap in the literature by examining changes in PTSD symptoms~     following PE treatment combined with a) 40 IU of intranasal oxytocin or b) placebo.~   "
25066|NCT03238911|"~     Treatment with iron isomaltoside and ferric carboxymaltose in subjects with iron deficiency~     anaemia and comparison of the incidence of hypophosphatemia.~   "
25067|NCT03238898|"~     Objective: previous studies suggest that botulinum toxin A (BoNT/A) can reduce muscle~     hyperactivity.~      Research Design and Methods: a single-center, double-blind and placebo-controlled study~     investigating the efficacy and safety of BoNT/A intramuscular injection for treating calf or~     foot cramps refractory to common pharmacological drugs in patients with diabetic peripheral~     neuropathy. Fifty patients were subdivided in two matched groups (cases and controls) and~     BoNT/A (100 or 30 units) was injected for each side into the gastrocnemious or the small~     flexor foot muscles, respectively, according to the predominance of leg or foot cramps.~     Responders were evaluated again with a second BoNT/A administration.~      The changes of pain intensity (primary outcome) and the changes in cramp frequency, the and~     the Cramp Severity Scale (CSS) were evaluated over the course of 20 weeks after BoNT/A~     administration.~   "
25068|NCT03238885|"~     This study plans to construct a MR radiomics model for predicting pathological complete~     response(pCR) to neoadjuvant chemoradiotherapy(CRT) in locally advanced rectal cancer(LARC)~     patients.~   "
25080|NCT03238729|"~     This study assesses the ability of ambulatory patients with heart failure (HF) to use a~     smartphone application created for the management of patients with chronic HF. This study~     will aim:~        -  To understand the frequency with which ambulatory HF patients engage with this~          smartphone application.~        -  To determine whether patient's knowledge of HF and its management has improved with the~          use of this smartphone application.~        -  To assess improvement in quality of life measures related to the use of this smartphone~          application.~        -  To assess improvement in lifestyle measures related to the use of this smartphone~          application.~   "
25069|NCT03238872|"~     Anxiety and depression are among the most common mental disorders in the population. Anxiety~     and depression have significant consequences at the individual, family and community level,~     and mental illness is estimated to cost the Norwegian society 180 billion Norwegian kroner~     annually. The majority of this amount is accounted for by anxiety and depression disorders.~     Meanwhile, access to mental health services to treat these disorders is limited. The~     proportion of people who do not receive treatment of those who are in need of treatment is~     estimated to be over 50%.~      Prompt Mental Health Care (PMHC) is a pilot project initiated in 2012 by the Directorate of~     Health commissioned by the Ministry of Health, with the goal of increasing access to~     evidence-based treatment for adults with anxiety disorders and mild-to-moderate levels of~     depression. The treatment offered is cognitive behavioural therapy and should lead to reduced~     levels of symptoms of anxiety and depression, improved quality of life and better~     employability. PMHC is based on the English program Improving Access to Psychological~     Therapy (IAPT), which is established in virtually all health communities in England.~      The evaluations of IAPT and PMHC have until now been based on relatively weak research~     designs which make it difficult to know to what extent the initiative really has the desired~     effect. In this study, PMHC is compared with a control group that receives treatment as usual~     (often provided by the general practioner) in two PMHC pilot sites (Kristiansand and~     Sandnes). Participants are randomly assigned to either the PMHC or the control group. The~     investigators aim to include 1100 clients in the study.~      The key objectives of this study are to investigate whether PMHC treatment is more effective~     as compared to treatment in the control group with regard to symptoms of anxiety and~     depression, work participation, functional status, and mental well-being. Cost-effectiveness~     of PMHC is also examined.~   "
25070|NCT03238859|"~     The goal of this double-blind sham controlled study is to evaluate the effeicacy of~     continuous theta burst stimulation to the frontal pole as a tool to decrease drug cue~     reactivity and improve treatment outcomes in treatment-engaged cocaine and alcohol users. All~     participants will be randomized to receive 10 days of real or sham rTMS to the frontal pole.~     Brain imaging data and behavioral assessments will be collected at 4 time points - before~     TMS, after 10 days of TMS, 1 month follow up and 2 month follow up.~   "
25071|NCT03238846|"~     This study aims to evaluate the effectiveness of two strategies for multi-month dispensing~     (MMD) of ART in Community ART Refill Groups (CARGs) on retention, virologic suppression, and~     cost compared to standard of care.~      This study is a three-arm cluster-randomized controlled trial conducted among 5,760 stable~     HIV-positive patients) in Zimbabwe to compare outcomes of three antiretroviral therapy (ART)~     dispensing models. Outcomes of retention in care, virologic suppression, and cost~     effectiveness will be investigated in 30 purposively selected clusters (facilities) which are~     randomized into three arms; standard of care (3 months dispensing at facilities), three-month~     dispensing in CARGs, and six-month dispensing in CARGs. Each study arm will have 10 clusters~     stratified into 2 urban and 8 rural. Study participants will be followed, and outcomes will~     be measured at 12 months and 24 months. Qualitative research will be conducted at baseline,~     12 months, and 24 months (20 participant Focus Group Discussion (FGDs) and 20 provider Key~     Informant Interview (KII) at each interval) to understand patient and health provider~     acceptability of multi-month dispensing of ART within CARGs. Other outcomes of interest~     include measuring gains of facility decongestion and feasibility of multi-month dispensing of~     ART within CARGs. Cost analysis will include comparisons of patient level costs, cost per~     patient outcomes and cost effectiveness across the three study arms.~   "
25072|NCT03238833|"~     The investigators attempted to compare the clinical outcomes and cumulus genes expression in~     poor ovarian responders undergoing luteal ovarian stimulation or follicular ovarian~     stimulation in in vitro fertilization cycles.~   "
25073|NCT03238820|"~     Patients with gastric gastrointestinal stromal tumors will receive robotic resection.~   "
25074|NCT03238807|"~     Subfertility is the inability to conceive after 12 months of regular unprotected sexual~     intercourse. Around 15% of couples suffer from subfertility. As a treatment for subfertility,~     Assisted Reproductive Techniques (ART) have been a choice for subfertile couples. In Egypt in~     2010, Pregnancy Rate was calculated to be 36.2%, Live Birth Rate to be 25.7%.~      Implantation is the process by which the embryo adheres to the wall of the uterus.~     Endometrial receptivity plays the most important role for successful implantation after~     embryo quality. It is estimated that up to 70% of early pregnancy losses are due to failure~     of implantation.~      Despite extensive research, the embryo-maternal dialogue that orchestrates the implantation~     process is still not fully understood. Much effort has been done in the last decades to~     detect factors affecting Implantation and improve endometrial receptivity.~      Human Chorionic Gonadotropin (hCG) is a placental glycoprotein hormone that required to~     maintain pregnancy. Recent research data demonstrates that hCG is secreted very early by the~     embryo before implantation to facilitate it. hCG has been proved to cause attraction of~     inflammatory cells, promote angiogenesis, regulate chemical mediators at the endometrium.~     These effects proceed the classical role of hCG during pregnancy and could be a directly~     involved in and facilitating the implantation process.~      Studies have been conducted to study the effect of injection of different concentrations of~     hCG inside the uterine cavity before Embryo Transfer (ET) to improve endometrial receptivity~     and outcomes of In-Vitro Fertilization (IVF) or Intra-Cytoplasmic Sperm Injection (ICSI)~     cycles.~      A recent systematic review was conducted on 12 studies performing intrauterine injection of~     different doses of hCG before ET. Results of this study showed that there is increased~     pregnancy outcome after injection of intrauterine 500 IU of hCG. The study recommended a~     definitive large clinical trial with live birth as the primary outcome. There was no evidence~     that miscarriage was influenced by intrauterine hCG administration, irrespective of embryo~     stage at transfer or dose of intrauterine hCG.~      Aim of the study:~      To detect whether intrauterine injection of hCG before ET improves clinical outcomes in~     IVF/ICSI cycles.~   "
25075|NCT03238794|"~     It is unknown whether the bile acid pathway reacts differently to weight loss resulting from~     Roux-En-Y Gastric Bypass (RYGB) surgery than weight loss resulting from caloric restriction~     alone.~   "
25076|NCT03238781|"~     To evaluate the effect of AMG 301 compared to placebo on the change from the baseline period~     in monthly migraine days in subjects with migraine.~   "
25077|NCT03238768|"~     The overall objective of the proposal is to demonstrate the feasibility of providing~     increased calories and protein in the first week of life to very low birth weight (VLBW)~     preterm infants.~   "
25078|NCT03238755|"~     In this study, investigators plan to test whether statins can preserve and/or improve~     diastolic function among asymptomatic persons with HIV who are on anti-retroviral therapy.~     Both myocardial fibrosis and myocardial steatosis are thought to contribute to diastolic~     dysfunction and eventually overt heart failure in HIV. HIV-positive participants will undergo~     cardiac MRI/MRS imaging studies for the evaluation of myocardial fibrosis and myocardial~     steatosis prior to initiation of statin or placebo therapy and then two years after~     initiation of statin or placebo therapy. Traditional markers of cardiovascular (CVD) risk,~     systemic immune activation/ inflammation, HIV-specific parameters (i.e. CD4 count), and~     markers of myocardial stretch/injury will be assessed in relation to cardiac MRI/MRS~     outcomes.~   "
25079|NCT03238742|"~     The Efficacy of Xuebijing Injection in Adult Patients with Sepsis~   "
25123|NCT03238157|"~     Radiation retinopathy is a known complication of ocular radiation therapy. To date there is~     no known effective treatment. In addition to their anti-vascular endothelial growth factor~     (VEGF) properties, corticosteroids decrease the retinal capillary permeability by increasing~     the activity/density of tight junctions and acute inflammatory effects of radiation in~     various tissues.~   "
25083|NCT03238690|"~     The purpose of this study is to investigate the potential recovery of heart function in~     end-stage heart failure patients supported with a Left Ventricular Assist Device (LVAD)~     through applying a myocardial conditioning protocol. During myocardial conditioning, LVAD~     speed is reduced gradually in order to increase the work load of the heart. Multiple previous~     studies have shown that interventions like this may improve heart function and give patients~     the opportunity for a better quality of life.~   "
25084|NCT03238677|"~     The study will test two modifications to speech therapy for 40 school-age children with~     childhood apraxia of speech to determine how to improve treatment outcomes. The study will~     compare treatment that includes real-time visual feedback of the tongue during speech using~     ultrasound vs traditional therapy that does not include ultrasound visual feedback.~     Additionally, some children will be treated with a traditional schedule of 2 sessions per~     week, whereas others will be provided with treatment that begins with intensive training (10~     hours of therapy in one week) and progresses to a more distributed treatment schedule.~   "
25085|NCT03238664|"~     This randomized pilot trial studies how well robot-assisted laparoscopic high-intensity~     focused ultrasound works compared to robot-assisted radical cystectomy for thermal ablation~     of muscle invasive cells in patients with bladder tumors. Laparoscopic high-intensity focused~     ultrasound uses high frequency sound waves to deliver a strong beam to a specific part of the~     tumor and may lower the number of tumor cells released into the blood stream compared to~     radical cystectomy.~   "
25086|NCT03238651|"~     The purpose of this study is to determine the safety, tolerability, maximum tolerated dose~     (MTD) and/or recommended phase 2 dose (RP2D) of TAK-659 when administered in East Asian~     participants with NHL who do not have an effective standard treatment available and to~     characterize the plasma and urine pharmacokinetic (PK) of TAK-659 in East Asian participants~     with NHL.~   "
25087|NCT03238638|"~     This is a research study to test the combination of two drugs, pembrolizumab and epacadostat~     with the goal of benefiting subjects with head and neck cancers where prior or ongoing~     regimens with a PD-1 or PD-L1 inhibitor for the treatment of advanced head and neck cancer~     after platinum failure.~   "
25088|NCT03238625|"~     This study examines whether the injection of local anesthesia mixed with sodium bicarbonate~     in the ratio of 3:1 creates a less burning sensation and is as effective regarding the~     anesthetic effect as in the ratio of 9:1.~   "
25089|NCT03238612|"~     It is well recognized that respiratory viruses cause substantial disease burden every year.~     Among all known respiratory viruses, influenza virus is the greatest cause of~     disability-adjusted life years lost, excess hospitalizations, and deaths in the elderly and~     patients with chronic illness. These patients are frequently hospitalized for pneumonia~     secondary to these respiratory viral infection. Recently, macrolide antimicrobial~     clarithromycin and flufenamic acid (FFA) have been shown to inhibit seasonal influenza virus~     infection in human airway epithelial cells with additional anti-inflammatory effect.~      The investigators therefore plan to conduct a 3-year prospective study among adult patients~     hospitalized in Queen Mary Hospital for influenza with secondary pneumonia and randomized~     them to receive a course of oseltamivir + FFA + clarithromycin (as treatment) vs. a course of~     oseltamivir (current standard treatment as control). The objective of this prospective~     double-blind randomized controlled trial is to evaluate the efficacy of clarithromycin and~     FFA antiviral therapy in patients diagnosed to have pneumonia secondary to influenza~     infection.~   "
25090|NCT03238599|"~     The trial assess the proportion of patients who resumed their professional activity within~     100 days after ASCT (autologous stem cell Transplantation).~   "
25091|NCT03238586|"~     A clinical study for patients with HIV that investigates the best way to reduce HIV~     transmission risk, and to improve the overall health of people living with HIV/AIDS.~     Participants will complete four assessments over the course of one year and will be randomly~     assigned to a five-week treatment program.~   "
25092|NCT03238573|"~     When a polyp is found, we begin to wash it and observe it with OE mode 1.Then,the endoscopist~     gives a real-time optical diagnosis and the future surveillance interval.Finally,the polyp~     will be resected for the biopsy.~   "
25093|NCT03238560|"~     The investigators' aim was to evaluate the population pharmacokinetics of montelukast in~     infants and children and define the appropriate dose in order to optimize Montelukast~     treatment in this vulnerable population.~   "
25094|NCT03238547|"~     Microalbuminuria is an important biomarker for the development of diabetic nephropathy and~     cardiovascular complications. Since microalbuminuria is not easily detected on routine~     urinalysis, current guidelines recommend measuring spot urine albumin-to-creatinine ratio~     (uACR) annually in a patient with diabetes mellitus. While the standard method is~     quantitative measurement using turbidimetric immunoassay, it requires high cost and special~     laboratory equipment. This may be a hurdle that prevents screening for microalbuminuria in~     many patients with diabetes. Therefore, a semi-quantitative uACR test, which is rapid and~     inexpensive, could be used as a substitute to the current standard quantitative measurement.~     The investigators aimed to assess the diagnostic accuracy of a semi-quantitative urine~     albumin-to-creatinine ratio test, URiSCAN 2ACR, as a screening tool for microalbuminuria in~     patients with diabetes.~   "
25095|NCT03238534|"~     Comparison of Neobianacid® clinical efficacy to omeprazole in relief of heartburn or~     epigastric pain~   "
25096|NCT03238521|"~     To compare classical pedicle finder versus pedicle finder with impedancemetry on the~     perioperative radiation exposure of PPTLO. These two devices are already used in common~     practice.~   "
25097|NCT03238508|"~     This study will compare the microcirculatory resistance (IMR) of infarct-related artery (IRA)~     in patients who underwent immediate versus deferred stenting during percutaneous coronary~     intervention (PCI) for acute myocardial infarction.~   "
25098|NCT03238495|"~     The primary objective of this study is to determine the efficacy of metformin as a repurposed~     agent in human epidermal growth factor receptor 2 (HER2) positive breast cancer when added to~     standard neo-adjuvant chemotherapy.~   "
25099|NCT03238482|"~     The purpose of this study is to compare absorption of salmeterol and fluticasone from~     Salmeterol/fluticasone Easyhaler test products to the commercially available product Seretide~     Diskus~   "
25133|NCT03238027|"~     A Phase 1 dose escalation study to determine if SNDX-6352 will be sufficiently safe and~     well-tolerated at biologically active doses to warrant further investigation in patients with~     solid tumors.~   "
25100|NCT03238469|"~     With microwave ablation (MWA), using the heat generated from electromagnetic waves in the~     microwave energy spectrum, hair follicles and apocrine glands in the (hypo)dermis are ablated~     through thermolysis. MWA was recently approved for the treatment of axillary hyperhidrosis~     (miraDry) and removal of axillary hair (miraSmooth). By permanent removal of hairs and sweat~     glands, the investigators hypothesize a beneficial and long-term sustainable preventive~     effect of MWA in HS patients.~   "
25101|NCT03238456|"~     The current study aimed to test a culturally tailored program designed to help Pacific~     Islanders (PIs) between the ages of 18 and 30 quit smoking cigarettes by using a randomized~     controlled trial design with one intervention group and one control group.~   "
25102|NCT03238443|"~     The study is a prospective observational mono center study~      Primary objective :~      Study the anti-HLA antibodies frequency preformed before liver transplantation and the~     kinetic of appearance of DSA and de novo complement-binding anti-HLA antibodies after liver~     transplantation.~      Secondary objective :~        -  Risk factor of de novo DSA appearance (Immunosuppressive therapy, liver aetiology)~        -  Impact of DSA on:~             -  Graft and patients survivals~             -  Onset of allograft rejection (acute, late-onset, chronic)~             -  Unexplained liver graft dysfunction~             -  Unexplained liver enzymes abnormalities~             -  Liver fibrosis development (liver stiffness study using fibroscan©)~   "
25103|NCT03238430|"~     Analgesia in liver surgery is a challenge, postoperative coagulopathy risk raises fears an~     epidural haematoma formation following the epidural analgesia, gold standard in major~     abdominal surgery. The spinal analgesia and/or continuous wound infiltration of local~     anesthetics constitute so an alternative.~      The study will compare the continuous infiltration of local anesthetics and rachianalgesia in~     terms of decreased postoperative morphine consumption and incidences of chronic postoperative~     pain at 3 and 6 months after hepatic surgery compared to the control group.~   "
25104|NCT03238417|"~     Gaps in delivery of gender-sensitive comprehensive care have resulted in disparities in~     quality and patient experience among women seen in VA. VA policy action providing guidance on~     delivery of comprehensive healthcare services for women Veterans was disseminated nationally~     in 2010, followed by annual assessments and sites visits evaluating local VA efforts. While~     substantial inroads have been made, policy implementation, even when leveraged by field-based~     women's health leaders, has not been uniformly successful in achieving delivery of~     comprehensive care by designated providers in gender-sensitive care environments that ensure~     women's privacy, dignity and safety, all tenets of the original guidance and the updated VHA~     Directive (2017).~      In collaboration with VA Women's Health Services (WHS), VA researchers developed a series of~     studies to better understand and help improve comprehensive care implementation through the~     Women Veterans' Healthcare CREATE Initiative. Among these, one focused on testing an~     evidence-based quality improvement (EBQI) approach to tailoring VA's medical home model --~     Patient Aligned Care Teams or PACT -- to the needs of women Veterans, which has yielded~     significant local improvements in women Veterans' care. EBQI emphasizes a multilevel~     partnered approach to building capacity for innovation, implementation and spread of~     evidence-based practice. With its demonstrated success in the CREATE PACT study and several~     other EBQI trials, WHS adopted EBQI as a strategy to help low-performing VA facilities~     systematically improve services.~      The objectives of the WHS/QUERI Partnered Evaluation Initiative that this project represents~     are:~        1. To evaluate the barriers and facilitators to achieving delivery of comprehensive women's~          health care in the identified low-performing VA facilities;~        2. To evaluate the effectiveness of EBQI in supporting low-performing VA facilities achieve~          improved:~             1. Organizational features (e.g., level of comprehensive services available; care~               coordination arrangements; PACT features implemented; environment of care~               improvements);~             2. Provider/staff attitudes (e.g., improved gender awareness; women's health knowledge~               and practice);~           d) Quality of care and patient experiences among women Veteran patients using secondary~          data; and,~        3. To evaluate contextual factors, local implementation processes, and organizational~          changes in the participating facilities over time.~      Results of the evaluation will be used to provide feedback to stakeholders, including women~     Veterans, at the local, network and national levels, while also being used to continuously~     refine EBQI implementation processes. The evaluation will also help inform optimal strategies~     for ongoing improvements in women Veterans' care in the 24 participating VA facilities, other~     VA facilities and for other improvement initiatives in this and other program offices.~   "
25105|NCT03238404|"~     Patients with advanced gastric cancer received neoadjuvant chemotherapy undergo enhanced~     recovery after surgery (ERAS) programs.~   "
25106|NCT03238391|"~     The purpose of this study is to demonstrate the effectiveness of ischemic preconditioning in~     the emergency department to prevent contrast induced nephropathy~   "
25107|NCT03238378|"~     The aim of the present trial is to assess the prospective results of protocol-based~     interstitial pulsed-dose-rate (PDR) brachytherapy with interstitial hyperthermia (iHT) in a~     group of selected patients where salvage surgery with clear resection margins was not~     possible.~   "
25108|NCT03238365|"~     This randomized pilot early phase I trial studies how well nivolumab with or without~     tadalafil work in treating patients with head and neck squamous cell carcinoma that has come~     back and can be removed by surgery. Monoclonal antibodies, such as nivolumab, may interfere~     with the ability of tumor cells to grow and spread. Tadalafil may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. Giving nivolumab and tadalafil~     may work better in treating patients head and neck squamous cell carcinoma.~   "
25109|NCT03238339|"~     The subjects of this study are the chronic obstructive pulmonary disease (COPD) patients with~     chronic II respiratory failure. The participants will be divided into two groups: The~     Portable Home Noninvasive Ventilator treatment group and the routine home oxygen inhalation~     treatment group. All subjects will be given a stable COPD regimen and conventional oxygen~     therapy ,but the portable home noninvasive ventilator treatment group will need to wear a~     portable non-invasive ventilator. Objective evaluation indexes were established during the~     routine treatment, and two groups of subjects will be followed up for one year. Finally, the~     clinical data of all subjects will be analyzed，and then the practicability of portable~     wearable household noninvasive ventilator will be verified.The researchers will also build a~     remote breathing data-monitoring platform based on mobile internet,and a community home~     demonstration application point.~   "
25110|NCT03238326|"~     To further characterize the long-term safety and tolerability of brexpiprazole in adolescents~     with schizophrenia~   "
25111|NCT03238313|"~     The purpose of the study is to determine if exposure to the Plan A video causes decreased~     risky sexual behavior among the target population.~   "
25112|NCT03238300|"~     This study will examine the effect of N-Acetylcysteine (NAC), an over-the-counter antioxidant~     supplement, on brains of youth (ages 15-19) using magnetic resonance imaging (MRI). 55~     adolescents will receive, in a counterbalanced order, a 10-day course of NAC 1200 mg twice~     daily and a subsequent 10-day course of matched placebo twice daily, separated by 11 days.~     Urine and blood samples will be collected at baseline and urine samples again before and~     after each course of medication treatment. Participants will receive a 1- hour MRI scan at~     baseline and after each treatment trial.~   "
44881|NCT02979366|"~     The CL1-64315-001 study is a phase I, international, multicentre, open-label, non-randomised,~     non-comparative study. This study is designed in two parts: one part for dose escalation, one~     part for dose expansion.~   "
25113|NCT03238287|"~     Post-resuscitation neurological impairment is associated with morbidity and especially with~     late mortality. Thus, because good neurological outcome is vital for a successful~     resuscitation, it is essential to have sufficient cerebral tissue perfusion and oxygenation~     during its application. Near-Infrared Spectroscopy (NIRS) is used to evaluate such~     conditions. NIRS is a non-invasive technique which provides real-time, continuous information~     about regional cerebral tissue oxygen saturation levels (regional SO2/rSO2). Research on NIRS~     has been done in many studies including cardiovascular surgery, neurosurgery and their~     intensive care processes and its effectiveness has been approved. However, there is limited~     data on its use in cardiac arrests.~      As stated in the current guidelines, sufficient speed and depth of chest compressions, few~     interruptions of compressions are key to a successful outcome of resuscitation. The studies~     with the mechanical chest compression devices showed that the earlier it was applied in~     out-of-hospital cases, the higher the rates of survival until hospitalization. There is not~     sufficient number of studies on the routine use of mechanical chest compression devices for~     in-hospital cases. In case the application of manual resuscitation is not convenient (during~     patient relocation, procedure at the angiography laboratory, and rush hours of emergency~     services when staff might fall short), alternative methods will be required.~      The aim of our study is to compare rSO2 levels measured during resuscitation with manual and~     mechanical devices in in-hospital (at the emergency department) witnessed cardiac arrest~     cases and to analyze the impact of both application method and perfusion levels on survival~     and neurological outcome.~   "
25114|NCT03238274|"~     The objective of this study is to demonstrate the clinical performance of the Sofia® 2~     analyzer and Sofia Lyme FIA test in the CLIA waived test environment in comparison to~     Comparator Method(s) and/or an FDA cleared predicate test(s) using matched finger-stick,~     whole blood and serum from symptomatic subjects.~   "
25115|NCT03238261|"~     Compare the use of radiotherapy and concomitant chemotherapy, with the single use of~     radiotherapy in the treatment of patients with stage IIIB uterine cancer, having as an~     outcome the three year survival rate, the disease free survival rate, the locoregional~     control of the disease and the security of the treatments provided.~      Specific objectives~        1. Describe and compare the demographic and clinical characteristics of both groups.~        2. Compare the three year survival rate in both groups.~        3. Compare the response to treatment in terms of locoregional control of the disease.~        4. Compare the appearance of severe and non severe adverse events directly related to the~          treatment in both intervention groups.~   "
25116|NCT03238248|"~     This study will evaluate the treatment combination of pevonedistat and azacitidine in the~     setting of DNA methyltransferase inhibitor(s) failure in patients with relapsed/refractory~     myelodysplastic syndrome or myelodysplastic syndrome/myeloproliferative neoplasm.~   "
25117|NCT03238235|"~     This is a phase 2, randomised, double-blind, placebo controlled study to evaluate the~     micro-macroscopic effects on muscles, the safety and tolerability, and the efficacy of~     givinostat in patients with Becker Muscular Dystrophy. Approximately 48 eligible patients~     will be randomized in a 2:1 ratio to be treated with givinostat or placebo for a period of 12~     months.~   "
25118|NCT03238222|"~     Peripheral arterial disease can cause leg pain or discomfort (called intermittent~     claudication (IC)), which limits the ability to walk and carry out everyday activities.~     Lifestyle changes, like increasing walking, can lead to improvements, but can be a challenge~     to begin and then continue. The aim of this study is to investigate if a physiotherapist-led,~     behaviour change treatment effects walking in people with IC. The treatment is designed to~     build an understanding of IC and walking exercise and help individuals develop strategies to~     increase regular walking. The trial will recruit 192 adults (aged 50 years and over) with IC.~     All participants will visit King's College London or their local hospital to complete two~     short walking tests and answer questionnaires about their daily activities, beliefs about~     their symptoms and treatment, quality of life and the costs of having IC.~      Participants will then be randomly assigned to receive either the new treatment or continue~     with their usual NHS care. The new treatment involves two 60-minute face-to-face sessions (at~     the participant's home or local hospital) and two 20-minute telephone calls with a~     physiotherapist who will discuss participants' understanding and beliefs about IC, walking~     and help participants to set goals and plans to increase walking over 12 weeks. Participants~     will be provided with a step counter (pedometer) and walking record.~      After 12 weeks, all participants will attend a second appointment where they will repeat the~     walking tests and fill out another set of questionnaires. A final set of questionnaires will~     be completed by all participants after 6 months (by post or electronically). Some~     participants will be invited to provide feedback on their experience of the treatment and~     trial by telephone or a face-to-face interview with a researcher.~   "
25119|NCT03238209|"~     To evaluate the compatibility and correlation between noninvasive surface respiratory~     electromyography and invasive transesophageal diaphragmatic electromyography measurements, as~     facilitating indicators of neural respiratory drive evaluation during treadmill exercise.~     Transesophageal diaphragmatic EMG (EMGdi,es) and surface inspiratory EMG, including surface~     diaphragmatic EMG (EMGdi,sur), surface parasternal intercostal muscle EMG (EMGpara) and~     surface sternocleidomastoid EMG (EMGsc) were detected simultaneously during increasing~     capacity exercise in stable patients with COPD. EMGdi,es, EMGdi,sur, EMGpara and EMGsc was~     quantified using root mean square (RMS), which represent as RMSdi,es, RMSdi,sur, RMSpara and~     RMSsc.~   "
25120|NCT03238196|"~     This is an open-label, multi-institution, phase Ib trial that evaluates the safety and~     tolerability and preliminary anti-tumor activity of fulvestrant, palbociclib and erdafitinib~     in patients with ER+/HER2-/FGFR-amplified metastatic breast cancer.~   "
25121|NCT03238183|"~     Using double blind, randomized controlled design to study the immediate, short-term and~     intermediate-term therapeutic effects of ultrasound guided hyaluronic acid injection and~     hyaluronic acid combined dextrose injection to patients with knee osteoarthritis.~   "
25122|NCT03238170|"~     To assess the feasibility of acquiring an MR scan in the radiotherapy treatment position as~     part of the patient's radiotherapy pathway and incorporating the data into our radiotherapy~     planning systems, so that it can be potentially used to reduce healthy tissue exposure to~     radiation. Subsequently, the protocols and procedures established can be used to put the~     technique into routine clinical practice.~   "
25124|NCT03238144|"~     This project is investigating a novel MRI method called Magnetic Resonance Force (MRF). MRF~     has been developed to accurately estimate tumour stiffness in the breast by measuring the~     interstitial fluid pressure (IFP).~      50 healthy volunteers will be recruited to extend the hardware and establish MRF imaging~     acquisition protocols for pre and post-menopausal women. Once completed, we will test this~     new imaging technique with the acquired imaging protocols on 100 patients undergoing surgery~     as first line of their treatment for their breast cancer to establish a potential biomarker~     signature predictive of lymph node involvement and metastatic potential. Simultaneously, 50~     patients undergoing chemotherapy as first line of their treatment for their breast cancers~     will be recruited to develop a biomarker signature that could predict response or resistance~     to neoadjuvant chemotherapy as determined by conventional imaging and histopathology.~   "
25125|NCT03238131|"~     Onchocerciasis is a vector-borne nematode parasitic disease that causes severe disability.~     Onchocerciasis affects approximately 33 million people, mostly in 30 countries in sub-Saharan~     Africa (with small foci in Latin America and Yemen) 1This disease causes blindness and severe~     skin disease and it is spread by black flies. O. volvulus adult worms live in subcutaneous~     nodules. O. volvulus adult worms are larger and less sensitive to available drug treatments~     than those of the species that cause Lymphatic Filariasis (LF). They also have a longer~     lifespan (approximately 14 years rather than the estimated 7 years for LF parasites). Several~     programs and developments have greatly improved the Onchocerciasis. situation since the~     1970's when the Onchocerciasis Control Programme (OCP) in West Africa (green countries in the~     map) was initiated. OCP relied exclusively on vector (black fly) control in its early years.~     However, following the appearance of Ivermectin (Mectizan) on the scene in the late 1980's,~     OCP transitioned to become a drug distribution program with annual IVM MDA in 11 countries.~     OCP ended in 2002. This was replaced by the African Program for Onchocerciasis Control (APOC)~     which coordinates community directed distribution of IVM MDA in 28 African countries~     (including the former OCP countries). OCP and APOC have done a good job of reducing parasite~     infection intensities and Onchocerciasis disease rates in many endemic countries.~     Unfortunately, there is no real end in sight for the APOC approach (apart from a funding~     endpoint in 2015); while it may be possible to eliminate Onchocerciasis. In selected areas by~     MDA with IVM (alone, or combined with vector control), disease control programs in most~     African countries will require active maintenance for many years to come. While IVR has good~     activity against the parasite larvae that cause disease in the skin and eye (microfilariae or~     Mf), it does not kill O. volvulus adult worms, and they resume production of Mf that can lead~     to transmission of new Onchocerciasis. Cases by black flies after a few months. APOC~     activities are focused on areas with high infection rates (where disease risks are highest).~     However, extensive areas in Africa where fewer than 20% of adult men have Onchocerciasis~     nodules detectable by palpation are not receiving interventions for Onchocerciasis at this~     time. These areas are not disease free. (Onchocerciasis dermatitis can be severe in~     hypoendemic areas), and they also may serve as a source for reintroduction of the parasite~     into previously controlled areas after interventions stop.~   "
25126|NCT03238118|"~     The aim of this project is to evaluate the efficacy of an attention bias modification~     training if compared to an attention control and psychoeducation to reduce the symptoms of~     irritability among children with high levels of irritability.~   "
25127|NCT03238105|"~     Periorbital hyperchromia (POH) or periorbital hyperpigmentation, commonly known as dark~     circles, is a relatively common condition and a frequent reason for dermatological~     consultation. It is defined as brown-colored pigmentation, ranging from light to dark, which~     mainly involves the lower eyelids. POH affects individuals over a wide age range, including~     both sexes and all ethnicities, and is associated with a tired and aged facial appearance.~     The most commonly affected people are those with the highest skin phototypes. Although the~     prevalence is similar between sexes and age groups, POH is a more frequent complaint in~     women. The dark circles characteristic of POH can negatively impact patients' quality of~     life, although it is not a condition associated with morbidity. Despite its high prevalence,~     only a few well-designed studies were done to evaluate its therapeutic options. The intense~     pulsed light (IPL) and the thioglycolic acid are safe treatment options and promote the~     improvement of dark circles, but it is not known if one treatment differs from the other in~     relation to efficacy and adverse effects.~   "
25128|NCT03238092|"~     In vitro fertilization(IVF) with Gonadotropin-releasing hormone (GnRH) antagonist is one of~     the most used protocol for the treatment of infertile couples nowadays. Despite several~     advantages over GnRH agonist, the antagonist may be associated with a slightly reduction in~     pregnancy rates.~      Several medications have been tested in order to increase ovarian response to ovulation~     induction, including estradiol and testosterone. A clinical trial in women with IVF~     indication will be performed and this women will be randomly assigned to receive topic~     testosterone, oral estradiol or no pre-treatment prior to IVF with human Chorionic~     Gonadotropin (hMG) and GnRH antagonist. The primary endpoint will be the size and number of~     follicles on the beginning of the cycle, after pre-treatment.~   "
25129|NCT03238079|"~     The purpose of this study is to investigate the efficacy, safety, tolerability, and~     pharmacokinetic profile of the investigational medicinal product (IMP) and to determine, on~     the basis of historical control data, how it compares with other 10% intravenous~     immunoglobulin (IGIV) products currently licensed in North America for the treatment of~     subjects with primary immune deficiency diseases (PIDD).~   "
25130|NCT03238066|"~     Salvage brachytherapy in combination with interstitial hyperthermia for locally recurrent~     prostate carcinoma following external beam radiation therapy.~   "
25131|NCT03238053|"~     Women with genitourinary syndrome of menopause, with breast or endometrial cancer are~     randomized to either laser treatment og sham treatment for 3 months. The randomization is~     stratified for estrogen treatment. The effect is evaluated by questionnaire, histology and~     microbiology swaps~   "
25132|NCT03238040|"~     This study is a large multi-centre collaboration between a busy regional paediatric intensive~     care transport service (Children's Acute Transport Service, CATS), four large paediatric~     intensive care units (PICUs at Great Ormond Street Hospital, St Mary's Hospital and Royal~     London Hospital in London, and Addenbrookes Hospital in Cambridge) and the Department of~     Paediatrics at Imperial College, London. CATS transports over 800 sick children on life~     support to the three PICUs each year.~      We aim to improve our understanding of the genetic basis and biological pathways by which~     children with acute infection or injury become critically ill and develop failure of vital~     organs, and how these factors influence outcome. We will establish well-characterised cohorts~     of sick children with diverse pathologies, in whom blood, urine and other samples will be~     collected at an early stage of critical illness. Samples will be analysed using genomic,~     transcriptomic, proteomic and metabolomic approaches. Advanced bioinformatics techniques will~     be used to identify biomarkers for early diagnosis and robust risk stratification. We will~     focus on biomarkers to help distinguish between serious bacterial infections, viral~     infections and other causes of critical illness; diagnose incipient organ failure; and~     accurately identify, early on, children at high risk of developing a poor outcome.~      We will recruit critically ill children at first contact with the CATS team, during emergency~     transport to PICU. Due to the emergency nature of the research, and minimal risk associated~     with the study procedure, we will seek deferred, written informed consent from~     parents/guardians once their child has been stabilised, within 24-48 hours following PICU~     admission.~      By studying these important questions, we aim to better understand how we can diagnose and~     provide early life-saving treatments to critically ill children. The research team have an~     established track record of successful completion of several large clinical studies in~     critical care as well as validation of biomarkers in other diseases.~   "
25134|NCT03238014|"~     High-intensity noninvasive positive pressure ventilation (NPPV), which can well improve the~     gas exchange and reduce the work of breathing of patients, is a new strategy targeted at~     maximally reducing arterial carbon dioxide. However, no definitive conclusions have been~     drawn to decide whether high-intensity NPPV is the best setting for treating patients with~     chronic hypercapnic COPD. For now, no unified method for setting up high-pressure NPPV has~     been established. Most of the trials utilized gradually increased inspiratory positive airway~     pressure depending on the patient's tolerance. However, from a respiratory physiology point~     of view, excessive inspiratory positive airway pressure may lead to lung hyperinflation,~     increased intrinsic positive end expiratory pressures, increased oxygen consumption, and~     ineffective work of breathing.Therefore, seeking a method to establish individualized~     high-intensity NPPV is of vital importance.~   "
25135|NCT03238001|"~     The overall objective of this study is to demonstrate the safety and effectiveness of~     DCTclock as an adjunctive tool for use by clinicians to evaluate cognitive function in adults~     aged 55-95.~   "
25136|NCT03237988|"~     This will be a Phase 1, open-label, randomized, 3-way crossover study to evaluate PK, safety,~     and tolerability of a new tablet formulation of CPI-444 and to evaluate the effect of food on~     single oral doses of CPI-444 tablets in healthy male and female subjects. Potential subjects~     will be screened to assess their eligibility to enter the study within 28 days prior to the~     first dose administration.~   "
25137|NCT03237975|"~     1. Objectives of the Project~           The BEYO project is designed based on the middle range theory of self-care of chronic~          illness and salutogenic theory. The aim of this project is to facilitate self-care~          behaviours of community-dwelling elderly patients with type 2 diabetes through promoting~          SOC, and accordingly improve their health outcomes, including promoting quality of life~          and reducing diabetes-related emotional distress.~        2. Content of the Project~      BEYO is a group-based consultation project. Each group contains 1 facilitator, 1 assistant~     and 8 elderly patients. 5 weekly sessions are provided to let patients receive health~     knowledge, discuss problems and experiences, explore available resources and build up goals~     and solutions. Each session lasts for 40 minutes. Session 1 aims to build social network~     among group members and introduce group goals and tasks. Session 2-4 covers six topics based~     on the Chinese guideline for type 2 diabetes released by Chinese diabetes society: (i)~     healthy dietary, (ii) exercise and activity, (iii) taking medication, (iv) blood glucose~     monitoring, (v) reducing risks for complication, (vi) healthy coping with mental stress.~     These middle sessions execute a common session flow to construct an action plan utilizing~     patients' resources and strengths to achieve the client-centered goal. Session 5 aims to~     review the process, summarize effective solutions, and set up plans for the future. One-week,~     one-month and three-month telephone follow-ups are delivered to help patients solve problems~     encountered during implementing the action plan and evaluate their self-care, SOC and other~     health outcomes.~   "
25138|NCT03237962|"~     The primary purpose of this study is to compare and assess the immediate and long-term~     effects on pulmonary rehabilitation training with the usage of HFNC or conventional oxygen~     therapy device.~      The hypotheses was, with high flow nasal cannula usage while exercising, the physiological~     outcome measurements would be better than conventional oxygen therapy device. Also, the usage~     of HFNC can immediately increase patient's exercising endurance and decrease dyspnea caused~     by exercising.~   "
25139|NCT03237949|"~     This is an extension of a previous feasibility study (Clinical Trials Registry -~     NCT02571244). The actual study is a research aimed to compare the effectiveness of telephone~     counseling and personalized text messages (TM) for supporting post-discharge quit attempts~     among hospitalized smokers, with focus on smoking cessation as the main outcome. Smokers~     patients will receive brief interventions and nicotine replacement therapy during the~     hospitalization. After discharge smoker patients will be allocated into a intervention or~     control arm. In the first and third months, after randomization, the patients will be contact~     to smoke abstinence assessment.~   "
25140|NCT03237936|"~     The proposed 3-month study is a prospective, open-label, multicentre, phase IV, proof of~     concept study. The study is designed to assess the effect on the quality of vision of~     IKERVIS® (1mg/mL ciclosporin) eye drops administered once daily in dry eye disease (DED)~     patients with severe keratitis, as well as its safety and efficacy.~   "
25141|NCT03237923|"~     The EasySense device is a non-invasive device designed to measure lung fluid in patients with~     Congestive Heart Failure (CHF). This study seeks to evaluate the efficacy of the EasySense~     system in measuring lung fluid volume.~   "
25142|NCT03237910|"~     AMSA trial is a multicenter, randomized, controlled study in out-of-hospital cardiac arrest~     patients.~      The purpose of the study is to test the hypothesis that a real time AMSA analysis during CPR~     may predict the success of defibrillation and optimize the timing of defibrillation delivery.~      The primary end-point is the efficacy of the AMSA-CPR: termination of VF/VT with achievement~     of ROSC for an AMSA ≥ 15.5 mV-Hz~      All patients meeting inclusion/exclusion criteria and receiving cardiopulmonary resuscitation~     are randomized into two groups: AMSA-guided CPR or standard CPR.~      In the AMSA-CPR group, AMSA value suggests when the rescuer should deliver the defibrillation~     attempt; In the Standard-CPR group, the defibrillation is delivered based on the 2015~     European Resuscitation Council (ERC) CPR guidelines.~   "
25143|NCT03237897|"~     The purpose of the study is to evaluate the value and effectiveness of a newly-implemented~     preoperative education class for patients undergoing colorectal surgery.~   "
25144|NCT03237884|"~     Palliative Care procedures should be integrated early in the course of disease of patients~     with advanced incurable cancer. With this study, where the investigators follow adult~     patients with incurable cancer over 6 months or until death (whatever occurs earlier), the~     investigators aim to identify patients' needs for Palliative Care interventions (like support~     in illness understanding and decision making, symptom management, concrete end-of-life~     preparation, and others) and their remembered delivery by health care professionals. The~     investigators also collect data on patients care (use of chemotherapy, intensive care in the~     last month of life) and quality of death and dying (assessed by post-death-interviews with~     bereaved relatives). The aim is to have a reality map on current integration of oncology~     and palliative care and to test if appropriate Palliative Care interventions predict a better~     outcome.~   "
25145|NCT03237871|"~     As part of the development of the Engaging Microenterprise for Resource Generation and Health~     Empowerment (EMERGE) Project, the study team will conduct a single-group study to examine the~     feasibility of assessing economic and sexual risk behaviors using text messages. The team~     will enroll approximately 20 young adults, aged 18 to 24, who are African-American, homeless,~     out-of-school, and un/under-employed. Participants will complete a text-messaged survey each~     week for 5 weeks. The study team will collect information about the number of participants~     who respond to the weekly survey, the number of questions to which they respond in each~     survey, and the number of hours from sending a survey to participants to receiving their~     response. As an exploratory aim, participants will also receive 3 informational text messages~     each week for 5 weeks on HIV prevention and economic empowerment. The study team will obtain~     qualitative feedback from participants regarding text messages they most and least liked. The~     survey is not designed to evaluate the effectiveness of the text message intervention.~   "
25146|NCT03237858|"~     The MANAGE-HF study is a multi-center, global, prospective, open label, multi-phase trial~     intended to evaluate the clinical efficacy of the HeartLogic heart failure diagnostic~     feature.~   "
25147|NCT03237845|"~     The purpose of this study is to compare the efficacy of BHV-3000 (rimegepant) versus placebo~     in subjects with Acute Migraines~   "
25148|NCT03237832|"~     This Phase 1 study intends to determine the safety and tolerability of ARN-6039 in healthy~     subjects.~   "
25149|NCT03237819|"~     Thrombotic Thrombocytopenic Purpura (TTP) is a potentially life-threatening thrombotic~     microangiopathy caused by a severe deficiency of ADAMTS13 (a disintegrin and~     metalloproteinase with a thrombospondin type 1 motif member 13). Decreased ADAMTS13 activity~     leads to an accumulation of ultralarge von Willebrand factor (vWF) multimers which induce~     aggregation of platelets and microthrombi. These microthrombi may involve the brain, heart,~     kidneys and lead to life-threatening organ failures.~      In experimental models, magnesium sulfate increases cleavage of newly released vWF by~     ADAMTS13, decreases the endothelial secretion of ultralarge vWF and inhibits the interaction~     of vWF with platelets. In another thrombotic microangiopathy, magnesium sulfate has been~     shown to reduce the risk of seizures in women with severe pre-eclampsia. In analogy with its~     evidence-based therapeutic application in pre-eclampsia and based on a strong rationale for~     magnesium supplementation in TTP, we propose a phase 3, double blind, placebo controlled, and~     randomized study to evaluate the efficacy of magnesium sulfate in more rapidly restoring~     normal platelet counts as measure of prevention of further microvascular thrombosis in~     patients with Thrombotic Thrombocytopenic Purpura.~   "
25150|NCT03237806|"~     The acute respiratory distress syndrome (ARDS) is characterized by severe respiratory~     failure. Open Lung and Lung Protective Strategy have been proved to improve mortality of ARDS~     patients. Preserving spontaneous breathing (SB) is good for inflating the lung lobe near~     diaphram during mechanical ventilation, however, strong respiratory drive could generate more~     transpulmonary pressure in ARDS patients, which increase the stress and strain in injured~     lung. Nonetheless, it's not clear if sedative has any effects on transpulmonary pressure of~     ARDS patients.The purpose of this study is to investigate the effects of sedation on~     transpulmonary pressure of ARDS patients.~   "
25151|NCT03237793|"~     The present study was designed as a randomised controlled clinical trial which was unicenter,~     double-blinded, parallel designed study, according to the Consolidated Standards of Reporting~     Trials (CONSORT) criteria, 2010. The study period was from July 2014 to September 2015.~   "
25152|NCT03237780|"~     This randomized phase II trial studies the side effects of atezolizumab with or without~     eribulin mesylate and how well they work in treating patients with urothelial cancer that has~     come back, spread to nearby tissues and lymph nodes, or other places in the body. Monoclonal~     antibodies, such as atezolizumab, may block tumor growth in different ways by targeting~     certain cells. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways~     to stop the growth of tumor cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Giving atezolizumab and eribulin mesylate may~     work better at treating urothelial cancer.~   "
25153|NCT03237767|"~     A great medical success is the increase in the median survival age associated with cystic~     fibrosis (CF). However, this success has led to a new era of research aiming to maximise the~     quality of life (QoL) of the aging CF population. Over recent decades, exercise training has~     become an integral part of CF management by improving ones aerobic exercise function and QoL.~     However, the effects exercise training has upon other aspects of the disease, e.g. metabolic~     and vascular abnormalities, remains largely unknown.~      The increased survival age associated with CF means the non-pulmonary co-morbidities are~     becoming increasingly prevalent and clinically important. For example, CF-related diabetes~     (CFRD) is one of the most common non-pulmonary co-morbidities of CF, and is associated with~     patients having a poorer pulmonary function and nutritional state, which ultimately leads to~     a worsened prognosis. Despite the efficacy of exercise training to manage dysglycaemia in~     other populations (e.g. type 2 diabetes mellitus only a single study has investigated its~     efficacy in patients with CF, whereby authors reported various encouraging findings (e.g. an~     improved OGTT score and insulin sensitivity).~      The present study aims to build on previous trials by comparing the therapeutic effects of a~     single session of high-intensity interval exercise (HIIE) and moderate intensity exercise~     (MIE) upon the 24 hour, ambulatory glycaemic profile of patients with CF. Additionally, the~     present study will identify whether HIIE and/or MIE can mediate the consequences of transient~     hyperglycaemia when considering: biomarkers of inflammation, oxidative stress and nitric~     oxide (NO2) bioavailability, as well as functional measures of microvascular endothelial~     function.~      The present study supports the top 10 research priorities set by the CF Trust, by further~     investigating the potential for exercise training to prevent/manage multiple aspects of CF,~     including dysglycaemia.~   "
25164|NCT03237624|"~     The aim of this prospective randomized 3-month double-blinded single center study is to~     determine whether a chewing gum device with food additive chitosan, will aid in reducing~     gingival inflammation by supplementing traditional tooth brushing and flossing measures.~     Patients with mild to moderate gingivitis will be identified and enrolled in this~     investigation. All enrolled subjects will receive baseline oral hygiene brushing instructions~     and a baseline clinical examination of the gingiva. The test group will utilize the test~     chewing gum three times a day for a minimum 20-30 minutes duration; the control group will~     receive a placebo gum and use it in a similar manner. We will examine whether daily use of a~     functional chewing gum enhances improvements to brushing and flossing.~   "
25165|NCT03237611|"~     Low dose aprepitant for patients receiving carboplatin.~   "
26304|NCT03222674|"~     The purpose of this clinical trial is to assess the feasibility, safety and efficacy of~     multi-CAR T cell therapy targeting different AML surface antigens in patients with relapsed~     or refractory acute myeloid leukemia (AML). Another goal of the study is to learn more about~     the function of the multi-CAR T cells and their persistency in the patients.~   "
25154|NCT03237754|"~     Currently, successful prevention of migraine is not sufficiently achieved by (prophylactic)~     drug therapy. In contrast, neurophysiologically guided treatments might provide an~     alternative avenue, since these can normalize brain alterations without side effects.~     Transcranial direct current stimulation (tDCS) appears useful in the acute and prophylactic~     treatment of migraine, probably because of its modifying and re-balancing influence on~     neuronal activity. Yet, to test for the efficacy of tDCS in a clinically acceptable way, it~     is necessary to apply not only tDCS but also a sham placebo, which is often neglected in~     tDCS stimulation studies. Further, tDCS needs to be applied in a large (n > 20) sample of~     well-defined migraine patients, which would be advantageous, compared to previously published~     work. Monitoring sources of regional neuronal alterations in migraineurs prior and after tDCS~     is essential to investigate physiological mechanisms of tDCS. There is an increasing interest~     towards non-pharmacological treatment alternatives for migraine (and headache disorders) with~     reduced side effects to established prophylactic medications. The primary outcome of this~     project is to demonstrate that repetitive sessions of neurostimulation lead to a significant~     and permanent reduction of the primary symptom severity (i.e. migraine attacks) for patients~     suffering from chronic and episodic migraine. Since neurostimulation tools are nowadays~     accepted as therapeutic tools, our study might provide evidence that tDCS can be a~     non-pharmacological alternative for treating migraine.~   "
25155|NCT03237741|"~     This study will evaluate the pharmacokinetics and safety of GDC-0134 in healthy female~     volunteers of non-childbearing potential. The first part of the study will compare the~     bioavailability of a prototype capsule of GDC-0134 relative to an existing GDC-0134 reference~     capsule (Periods 1 and 2). The second part of the study will assess the effect of~     GDC-0134-in-applesauce preparation under fasting conditions, the effect of low and high fat~     foods as well as the effect of elevated stomach pH via pre-treatment with rabeprazole, a~     proton pump inhibitor (PPI), under fasted and high-fat meal conditions (Periods 3 and 4).~   "
25156|NCT03237728|"~     Phase I study of multiple-dose Kukoamine B Mesilate in Sepsis Patients~   "
25157|NCT03237715|"~     Specific Aim 1: To determine total serum bilirubin (TSB) and unbound bilirubin (Bf) levels in~     term and late preterm infants during the first week of life.~      Specific Aim 2: Measure Bf levels in breast fed and formula fed infants and examine their~     relationship to unbound fatty acid (FFAu) levels.~      Specific Aim 3: To demonstrate that phototherapy results in different changes in TSB and Bf.~   "
25158|NCT03237702|"~     Through a better understanding of the biology of significant (lethal) prostate cancer, we~     hope to develop new markers/targets from urine metabolomics for more effective screening and~     prevention of significant prostate cancer. In the meantime, with these new markers we may~     substantially reduce overtreatment of insignificant PC.~   "
25159|NCT03237689|"~     Despite treatment with antiretroviral therapy, women living with HIV continue to experience~     cognitive impairment. Psychological risk factors, including stress, impair cognition more in~     HIV-infected women than HIV-uninfected women. This study plans to examine a novel~     intervention for cognitive dysfunction that targets the mechanisms by which stress negatively~     affects cognitive functioning.~   "
25160|NCT03237676|"~     This research is a randomised controlled study. The study hypothesis is cognitive~     rehabilitation for attention deficits following mild traumatic brain injury will improve~     patient's cognitive outcome, measured by neuropsychological and neuroimaging parameters.~     Participant recruitment is from University Malaya Medical Centre, Malaysia. All mild~     traumatic brain injury participants have to fulfil the study inclusion criteria and written~     consented for therapy. Control group receives existing patient-centred cognitive treatment~     whereas intervention group receives individualised structured cognitive rehabilitation~     therapy. The intervention begins at three months post injury and ends at six months post~     injury. Study outcome measurements are applied at pre and post treatment. This study was~     ethically approved by Medical Research Ethics Committee University Malaya Medical Centre~     (MREC ID NO: 2016928-4293).~   "
25161|NCT03237663|"~     Cholera is an acute enteric infectious disease caused by the bacterium Vibrio cholera,~     leading to watery diarrhea and loss of fluids from the small intestines. The World Health~     Organization (WHO) estimates that up to 4.3 million cholera cases annually with more than~     100,000 of them result in death in worldwide. Cholera is mainly caused by the O1 or O139~     serogroups of V. cholera. Vaccination has been shown to be a cost‒effective, more immediate~     option for cholera control and prevention. Injectable vaccine is not recommended by the World~     Health Organization (WHO) mainly because of its limited efficacy and short duration of~     protection. However, the inactivated whole-cell, bivalent O1 and O139 cholera vaccine have~     provided evidence of substantial protective efficacy. With the goal of making an ideal~     low-cost OCV that could be used in cholera-endemic countries, a phase I trial was conducted~     to estimate safety of the oral O1 / O139 cholera vaccine (enteric capsules).~   "
25162|NCT03237650|"~     Painful cutaneous electrical stimulation (PCES) and corresponding evoked potentials led to a~     significant pain relief and decrease of evoked potentials and has been used to analyze~     conditioned pain modulation (CPM). However, it is unknown whether the pain relief results~     from habituation to the repeated painful electric stimulation. We compared the effects of CPM~     and habituation on PCES-induced pain and PCES-evoked potentials and analyzed whether~     increased attention by a random change of electric intensities amplifies the habituation~     effects.~   "
25163|NCT03237637|"~     Through this study, the investigators shall compare the effectiveness of atenolol with~     propranolol in the treatment of IH. In addition, the investigators shall try to elucidate the~     mechanism of action of beta blockers by assessing their action on triggers such as hypoxia.~     The study design will be a parallel group comparative study wherein patients of IH will be~     randomized into two groups. One group will receive propranolol and the other atenolol for a~     maximum period of 9 months. The patients will then be followed up regularly for regression of~     the IH based on Physician global assessment, hemangioma activity score(HAS), serial~     photography and lesional ultrasonography. Any side effects encountered during the treatment~     period will also be noted. Also serial measurements of hypoxia inducible factor 1~     alpha(HIF-1α) will be made to ascertain the mechanism of action of the drugs.~   "
26305|NCT03222661|"~     The purpose of the study is to compare the final glasses prescription based on refraction~     obtained with SVOne device to the final prescription obtained via subjective manifest~     refraction.~   "
25166|NCT03237598|"~     With the development of economics in China, the dietary diversity got higher. Meanwhile, the~     prevalence of metabolic syndrome (MetS) raised up as well. To investigate the gender~     difference of getting MetS and its various associations with dietary diversity at different~     ages.Data of adults(n=4308) aged 18+ y with three consecutive 24-h recalls and complete~     co-variates information were extracted from Chinese Nutrition and Health Survey in 2009.~     Modified Dietary Diversity Score (DDS) was adopted to capture the diversity of diet. MetS was~     defined by the harmonized criteria. Multivariable adjusted logistic regression was carried~     out to detect the association between DDS and MetS and its components for young, middle aged~     and elderly adults by a cross-sectional study.~      More detailed information can be found in Pubmed,PMID: 24341753 (The China Health and~     Nutrition Survey, 1989-2011.).~   "
25167|NCT03237585|"~     AIM: To assess the community level impact of the Gender Centre's Rural Response System (RRS)~     in reducing violence against women (VAW) in Ghana.~      METHODS:~      Design: An unmatched cluster randomised controlled trial with two arms i) Intervention arm-~     Receive Gender Centre's RRS /COMBAT package for communities as well as state agencies.~     Control arm - No intervention. Qualitative component Setting: Rural and urban communities in~     the Central Region of Ghana. i). Rural and urban communities in four (4) Districts located in~     the Central Region of Ghana. Two districts are along the Coast (Abura and Komenda) while the~     other two (Agona and Upper Denkyira) are inland districts.~      ii). State Agencies (DOVVSU/Police, CHRAJ, Social Welfare, and Health Services).~      Interventions: Carried out in two Districts - Agona district and Komenda district. Workings~     of the intervention arm will be facilitated by the Gender Studies and Human Rights~     Documentation Centre in Ghana.~      Sample size: A total of 3280 adults (1640 women and 1640 men) from 20 clusters per trial arm~     (approximately 82 households per cluster) will be recruited at baseline and again at~     post-intervention survey. Sampling format will be a community survey with independent samples~     design (i.e. in each community, the people surveyed at baseline may not necessarily be the~     same people who are surveyed at post intervention. Clusters refer to the selected localities~     and their participating communities in each district.~      Evaluation design: Pre-test all study participants with a standardized instrument then~     introduce the independent variable (intervention) to the experimental group while withholding~     it from the control group. After 24 months of intervention, post-test both groups with the~     same instrument and under the same conditions as the pretest (baseline). Compare the amount~     of change in dependent variable for both experimental and control groups.~      Data analysis: The data will be analysed by intention to treat. The past 12 months prevalence~     of IPV will be compared between arms in the study.~   "
25168|NCT03237572|"~     This pilot study evaluates the use of high-intensity focused ultrasound (HIFU) combined with~     pembrolizumab in patients with metastatic breast cancer. One-half of participants will be~     randomized to receive the first dose of pembrolizumab after HIFU and one-half of participants~     will be randomized to receive their first dose of pembrolizumab before HIFU.~   "
25169|NCT03237559|"~     A Descriptive study to assess the knowledge, attitude and practice regarding eugenics among~     eligible couples of selected area of Ambala, Haryana, India. Eligible couples were the~     married couples where wife is in the age group of 15-45 years planning for conception, have~     conceived and may or may not have any living child.Eugenics are to methods that are adopted~     by eligible couples for having physically and psychologically healthy conception and~     pregnancy.~   "
25170|NCT03237546|"~     The purpose of this randomized, un-blinded study is to determine if serratus blocks or~     Patient Controlled Analgesia (PCA)-alone (no block) offer patients adequate pain relief. This~     study will compare two standard of care pain management options and the patients narcotic~     requirements in the immediate postoperative period.~   "
25171|NCT03237533|"~     Background: Oral lichen planus (OLP) is a chronic inflammatory mucocutaneous autoimmune~     disease mainly affecting stratum basal of the epithelium. It is very painful and hamper the~     daily routine of patients e.g. (talking, drinking, eating, maintaining normal relationships).~     Different topical treatments have been tried for the symptomatic relief of OLP which include~     topical corticosteroids (TCSs), topical calcineurin inhibitors (TCIs) retinoids,~     photochemotherapy; amitryptaline; thalidomide; amlexanox and traditional medicines such as~     curcumin, selenium-ACE combined with itraconazole, glycyrrhiza glabra and aloe vera. But the~     exact treatment is still unknown.~      Objective: To compare the efficacy of Dexamethasone, Doxycycline, Nystatin and Promethazine~     cocktail with Triamcinolone as topical treatment of OLP Subjects and Methods: 40 patients of~     symptomatic OLP will be randomly divided in to study and control group. Study group will be~     given a cocktail containing dexamethasone, doxycycline, nystatin and promethazine and will be~     advised to rinse with 1 and half teaspoon of this cocktail 3 times a day for 2 minutes for~     the period of 8 weeks. Study group is also advised to apply an orabase containing 0.1%~     triamcinolone on lesions 3 times a day for the period of 8 weeks. The control group will be~     advised to apply only triamcinolone orabase 3 times a day for 8 weeks.~   "
25172|NCT03237520|"~     This study intends to compare the efficacy of of virtual reality therapy(VRT) with modified~     constraint induced movement therapy(mCIMT) versus modified constraint induced movement~     therapy alone for children with hemiparetic cerebral palsy aged >/= 5-18 years, in improving~     the upper limb functions, as measured by the QUEST (Quality of Upper Extremity Skill Test~     score) over 3 months of intervention.~   "
25173|NCT03237507|"~     This is a non-interventional study，aim to observe the safety and efficiency of different~     treatment regimen for peritoneal metastasis of Stage IV gastric cancer in the real world~   "
25174|NCT03237494|"~     Estimation of the prevalence of TTR in patients with polyneuropathy or cardiomyopathy~     undetermined etiology~   "
25175|NCT03237481|"~     This is a Phase 3, randomized, double-blind, saline placebo- and active-controlled,~     multicenter study to evaluate the analgesic efficacy and safety of HTX 011 administered via~     local administration into the surgical site in subjects undergoing unilateral open inguinal~     herniorrhaphy.~   "
25176|NCT03237468|"~     Study looks to determine effectiveness of neck strengthening to reduce the incident,~     duration, and severity of sports related concussion in student athletes.~   "
25186|NCT03237338|"~     Insomnia disorder is one of the major neuropsychiatric diseases which received more attention~     in recent years. Disturbances in the amino acid neurotransmitter, gama-amino butyric acid~     (GABA) and hyperarousal of cortex are hypothesized to contribute to the neurobiology of~     insomnia. Both animal experiment and clinical observation have demonstrated that acupuncture~     can generate treatment effect on insomnia symptom. However, the underlying mechanism remains~     unclear. The principal objective of this project is to use magnetic resonance spectroscopy~     (MRS) as well as acupuncture to provide the first in vivo characterization of cortical GABA~     levels between pro- and post-acupuncture treatment in individuals with chronic insomnia~     disorder (CID), and use resting state functional magnetic resonance imaging (fMRI) to~     determine whether CID patients have altered brain connectivity and network parameter changes.~     The investigators are also exploring the correlation between cortical GABA levels, fMRI~     parameter changes and abnormalities in sleep parameters and neuropsychology test in CID~     patients.~   "
25177|NCT03237455|"~     Diffuse idiopathic skeletal hyperostosis (DISH) is a poorly understood, systemic condition~     characterized by progressive calcification and ossification of ligaments and entheses. The~     current classification criteria allow diagnosing the disease in its late course, when~     significant bony overgrowth already involves the vertebral column and the appendicular~     skeleton. The research of the pathogenic mechanisms in DISH, is significantly hampered by the~     late diagnosis resulting from this definition.Based on recent MRI studies in both axial~     spondyloarthritis (axSpA) and in DISH, it seems that changes similar to the classical early~     inflammatory changes described in axSpA, can be detected in patients with DISH. We therefore~     hypothesize, that patients with metabolic syndrome without radiographic evidence for spinal~     DISH, might exhibit early MRI changes. If this hypothesis proves to be correct, early~     diagnosis and research of the possible pathogenetic mechanisms at this early stage might be~     very rewarding in investigations of the early aberrations of the entheses homeostasis and~     eventually early, more targeted therapeutic interventions. The study will examine MRI changes~     in patients, in their 5th decade of life, with high risk for the development of DISH (ie~     diabetes mellitus, metabolic syndrome) compared with patients who don't have this risk.~   "
25178|NCT03237442|"~     Ocular chemical burn is one of the causes of vision loss in China, and there are no~     satisfactory treatment. Human umbilical cord mesenchymal stem cells(UC-MSCs) have the~     biological characteristics of self-renewal, immune regulation, multidirectional~     differentiation and tissue repair. Our preliminary research showed that in corneal alkali~     injury rabbits, the UC-MSCs can accelerated the cornea repair, inhibited angiogenesis. The~     aim of this study is to access the efficacy and safety of UC-MSCs in the treatment of corneal~     burn in human.~   "
25179|NCT03237429|"~     Arterial hypotension during induction of general anesthesia is a risk factor for developing~     postoperative cardiovascular complications. After induction of general anesthesia patients~     have a high risk of developing arterial hypotension due to anesthetic drugs who can depress~     cardiac contractility and determine vasodilatation. Previous studies have shown that even~     short periods of hypotension with a mean arterial pressure of less than 55 mmHg during~     surgery is associated with an increased incidence of cardiac injury and acute kidney injury~     in the postoperative period.~      The volemic status of the patients in the preoperative period is very difficult to quantify~     and can vary due to comorbidities of the patient, chronic treatment, preoperative fasting.~     Bioimpedance is recognized by over 30 years as a simple and non invasive technique to~     determine the volemic status especially in the hemodialysed patients. A new device BCM- Body~     Composition Monitoring (Fresenius Medical Care) offers a simple method to determine~     extracellular water and total body water. These volumes are determined by measuring impedance~     at 50 different frequencies thru electrodes placed at the ankle and wrist. BCM can also~     determine lean tissue mass and adipose tissue mass.~      Increasing arterial stiffness is the main characteristic of arterial aging; this increase~     determines the increase of the afterload, left ventricular hypertrophy, the decrease of~     coronary and tissue perfusion. Arterial applanation tonometry is a non-invasive technique~     that has been shown to reliably provide indices of arterial stiffness.~      In this study investigators wish to determine if there is a correlation between the hidric~     status determined by BCM, carotid-femural pulse wave velocity determined with SphygmoCor~     system and the development of hypotension during induction of general anesthesia. The~     measurements will be obtained before induction of general anesthesia in the pre-surgical~     area. During induction of general anesthesia with standard induction agents and Bispectral~     index monitoring, brachial blood pressure will be measured by a cuff every minute after the~     loss of verbal contact with the patient up to ten minutes after tracheal intubation. A~     hypotensive response to anesthesia will be defined as a drop in mean arterial pressure below~     55mmHg or a drop in mean arterial pressure with more than 40% than the base line value of the~     patient before the surgery.~      Measurement of the hidric status and aortic stiffness may represent a valid indicator of the~     risk of hypotension during anesthesia induction.~   "
25180|NCT03237416|"~     Evaluate the effect of darolutamide on the pharmacokinetics of a probe CYP3A4 substrate and~     Pgp substrate~   "
25181|NCT03237403|"~     Specify the association between clinical criteria transmitted by non-medical emergency~     services to the regulation of the SAMU centre call in patients with suspected sepsis and~     their hospital orientation: emergency department or intensive care unit~   "
25182|NCT03237390|"~     This phase I trial studies the side effects and best dose of ribociclib and gemcitabine~     hydrochloride in treating patients with solid tumors that have spread to other places in the~     body. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Giving ribociclib and gemcitabine~     hydrochloride may work better in treating patients with solid tumors.~   "
25183|NCT03237377|"~     This is a pilot study of neoadjuvant 'immunoradiation' (durvalumab or durvalumab plus~     tremelimumab) administered every 4 weeks for 2 doses, concurrently with standard thoracic~     radiation (RT) (45Gy in 25 fractions), with one dose of immunotherapy alone delivered in the~     pre-surgical window, prior to surgical resection, for patients with stage IIIA NSCLC that is~     deemed resectable with a lobectomy by a thoracic surgeon. If preliminary safety of the~     durvalumab/thoracic RT combination is established, a second cohort investigating the~     combination of durvalumab/tremelimumab/thoracic RT prior to surgical resection will be~     opened. After surgical resection, patients may receive standard adjuvant chemotherapy, as~     deemed appropriate by the treating investigator.~   "
25184|NCT03237364|"~     The goal of this study is to evaluate the utilization of conventional 'thermally' polarized~     perfluorinated gases mixed with oxygen as an exogenous inert contrast agent to image the~     airway spaces in subjects with suspected lung disease, post deployment in Iraq and~     Afghanistan. This is an open label proof of concept study expanding on work here at Duke.~   "
25185|NCT03237351|"~     Perioperative fluid management is a key component of anesthetic management during thoracic~     surgery. On one hand, fluid restriction could compromise perfusion of vital organs and~     surgical anastomosis. On the other hand, fluid overload could lead to cardiopulmonary~     complications, notably pulmonary edema, which carries a high mortality rate. Perioperative~     fluid management to avoid postpneumonectomy pulmonary edema has been previously reviewed.~     Therefore, to achieve the balance between preventing fluid overload and optimising organ~     perfusion, the practical index to guide fluid management, which can predict whether fluid~     loading will improve haemodynamic conditions in an individual patient, would be very valuable~     during lung surgery. Perioperative goal-directed fluid therapy (GDFT) is a cornerstone of~     tissue perfusion and oxygenation, and it can improve surgical outcomes. Respiratory~     variations of arterial pressure [i.e. pulse pressure variation (PPV) and systolic pressure~     variation] can predict fluid responsiveness in mechanically ventilated patients under various~     conditions. Therefore, pressure variations are increasingly being advocated for fluid~     management.This study will discuss the effects of pulse pressure variation(PPV) in different~     level during anesthesia on patients with oxygenation index and short-term prognosis~     undergoing video-assisted thoracoscopic surgery for pneumoresection.~   "
25188|NCT03237312|"~     In 1935 the polycystic ovary syndrome was a clinical diagnosis made on the morphological~     appearance of the ovaries in association with amenorrhoea, hirsutism and frequently obesity.~     At that time wedge resection of the ovaries was introduced on an empirical basis and proved a~     successful treatment for the associated anovulation and infertility. In the ensuing fifty~     years the limitations of a purely surgical approach to therapy have become recognized and the~     importance of the biochemical abnormalities appreciated. Prevalence of polycystic Ovary~     Syndrome: The prevalence of polycystic ovary syndrome in any specified population is~     dependent upon the diagnostic criteria used, but does have some regional and ethnic~     variation. While most reports on the prevalence of polycystic ovary syndrome range between 2~     and 20%, the chosen diagnostic criteria are recognized to influence the determined~     prevalence. Anti-mullerian hormone which is a predictor of ovarian reserve is known to~     decrease after laparoscopic ovarian drilling. On the best of our knowledge no study had been~     done to use the level of anti-mullerian hormone as a factor for planning the number of~     ovarian drills in each ovary.~   "
25189|NCT03237299|"~     To study the association between several exposures of interest and the occurrence of~     infectious loco-regional complications of pharyngitis in children.~   "
25190|NCT03237286|"~     This study has two aims: 1) to characterize the effects of intravenous ketamine on~     neurocognitive markers in depressed patients; 2) to test the efficacy of a synergistic~     intervention for depression combining intravenous ketamine with neurocognitive training.~   "
25191|NCT03237273|"~     Ultrasound represents a promising technique for the assessment of joint health in persons~     with haemophilia (PWH) by non-imaging specialists. The Haemophilia Early Arthropathy~     Detection with Ultrasound (HEAD-US) programme has been developed with the aim of integrating~     joint ultrasound in the routine assessment of PWH through the use of a simplified scoring~     system. The inter-operator reliability of the technique among European haemophilia treaters~     has been validated and described elsewhere. Further work is needed to assess the real-world~     impact of ultrasound on disease management and treatment decision-making.~   "
25192|NCT03237260|"~     The purpose of this research study is to determine whether starting the drug vedolizumab~     earlier than its FDA approved use can lead to better control of UC then using older drugs~     that we have historically used to treat UC. Vedolizumab is FDA-approved to be used after~     initial Corticosteroid treatments have failed or other UC treatments have failed. We will~     study if using vedolizumab as an early treatment for your UC will allow you to get off~     corticosteroids and prevent UC from worsening and requiring surgery.~      Vedolizumab is given intravenously initially every 2 weeks and then every 8 weeks.~   "
25193|NCT03237247|"~     Cases with extrahepatic cholestasis are common and faced during day to day clinical practice,~     however reaching the final etiology is sometimes challenging and needs investigations which~     are usually expensive, may carry hazards to the patients, or inaccessible so we are in need~     for a method which is easily available, affordable and safe for aiding in the differential~     diagnosis of extrahepatic cholestasis. our study aiming to evaluate the role of complete~     blood count in predicting the etiology of extrahepatic cholestasis.~   "
25194|NCT03237234|"~     For many people with spinal cord injury (SCI), the goal of walking is a high priority. There~     are many approaches available to restore walking function after SCI; however, these~     approaches often involve extensive rehabilitation training and access to facilities,~     qualified staff, and advanced technology that make practicing walking at home difficult. For~     this reason, developing training approaches that could be easily performed in the home would~     be of great value. In addition, non-invasive brain stimulation has the potential to increase~     the effectiveness of communication between the brain and spinal cord. Combining motor skill~     training with brain stimulation may further enhance the restoration of function in persons~     with SCI. Based on these findings, the primary aim of this proof-of-concept study is to~     inform future intervention development. To meet this aim, we will determine if~     moderate-intensity, motor skill training can improve walking-related outcomes among persons~     with SCI and to determine if the addition of non-invasive brain stimulation will result in~     greater improvements in function compared to training alone.~   "
25195|NCT03237221|"~     Asthma, abbreviation for bronchial asthma, is one of the common chronic airways disease that~     threatens human health. Typical symptoms of asthma are recurrent wheezing, shortness of~     breath, chest tightness and cough, usually occurring at night or early morning. However,~     there are still some patients with only persistent clinical manifestations of chest~     tightness. Concerned about this group of patients, we presented a subgroup of bronchial~     asthma, namely, chest tightness variant asthma (CTVA). This asthma subgroup usually lacks~     asthma-specific clinical features such as wheezing, shortness of breath, wheezing, and~     therefore often misdiagnosed for a long time. In order to further understand the clinical~     characteristics, pathogenesis, and prognosis of patients with CTVA, we conducted a national~     multicenter observation study to further understand CTVA. Finally, we plan to clarify whether~     CTVA is a relatively independent asthma phenotype. Meanwhile, reducing misdiagnosis and~     perform an appropriate treatment of CTVA.~   "
25196|NCT03237208|"~     The aim of the present trial was to investigate the analgesic efficacy and safety of~     Transcutaneous electrical nerve stimulation treatment in patients with renal colic within the~     emergency department.~   "
25197|NCT03237195|"~     Most patients with cancer of the head and neck are offered surgical resection of the primary~     tumor. In order to determine how the tumor will eventually behave, along with the resection~     of the primary tumor, lymph nodes present in the neck are also dissected. Different~     institutes have different protocol on handling of the specimen that is received by the~     pathology labs after dissection of the neck. The investigators intend to analyze the protocol~     that they use to evaluate the neck dissection specimen.~   "
25198|NCT03237182|"~     This is a randomized controlled clinical trial comparing treatment success of a gene-derived~     individualized drug-resistant Tuberculosis regimen to a standard Tuberculosis regimen based~     on South African National Tuberculosis guidelines.~   "
25199|NCT03237169|"~     To test the feasibility and diagnostic accuracy of a new automated pressure derived resting~     index (Pd/Pamin), using FFR as gold standard, in de novo coronary lesions in which invasive~     physiological evaluation is warranted.~   "
25200|NCT03237156|"~     The purpose of this study is to evaluate safety, tolerability, pharmacokinetics, and~     pharmacodynamics of single and multiple oral doses of TAK-906 in Japanese healthy male~     subjects.~   "
25201|NCT03237143|"~     Introduction: Erectile dysfunction occurs in a high percentage of patients today, showing not~     only an association with various pathologies but also frequent refractoriness to conventional~     pharmacological treatment options such as monotherapy. The objective of this study is to~     evaluate the response to low-intensity extracorporeal shock wave therapy in a group of~     patients with organic vascular erectile dysfunction with a history of more than three months.~      Materials and Methods: Observational retrospective study. The researchers reviewed clinical~     records of patients with a clinical diagnosis of organic vascular erectile dysfunction (ED)~     of more than 3 months duration, who received 5 outpatient shock wave therapy sessions, in the~     male sexual health clinics of the Boston Medical Group from Spain and Mexico. The patients~     were evaluated with the erection hardness score (EHS) before the first session, at the end of~     the last session and one month after the last session.~   "
25202|NCT03237130|"~     This study proposes to establish a CT radiomics-based prediction model for identifying~     metastasis lymph nodes in esophageal cancer.~   "
25203|NCT03237117|"~     105 infertile women are enrolled in the randomized controlled trial: 70 women with a history~     of RIF with donated oocytes and 35 infertile women undergoing the first oocyte donation~     attempt. Women receiving donated oocytes are treated with progressively increasing doses of~     oral estradiol followed by intravaginal progesterone after previous pituitary desensitization~     with GnRH agonist. 35 RIF patients are treated with GH (GH patients) while the rest 35 RIF~     patients (non-GH patients) and 35 first-attempt patients (positive control group) are not.~   "
25204|NCT03237104|"~     Half of all adolescents report experiencing low back pain (LBP), and adolescents who are~     active in sport report an even higher rate. The most common identifiable cause of LBP in the~     adolescent athlete is a stress fracture in the low back, known as a spondylolysis.~     Spondylolysis injuries have been found in up 47% of young athletes with LBP. The current~     recommendations of care for a spondylolysis consist of rest for at least 3 months, bracing,~     and physical therapy. These recommendations result in athletes being out of sport for as long~     as 46 months, and are based on low level evidence and expert opinion. In addition to the long~     period out of sport, 42% have poor long-term outcomes, and 1 in 6 athletes are no longer able~     to play at their former level specifically due to their back injury. These long periods out~     of sport and poor long-term clinical outcomes suggest current care recommendations are~     suboptimal.~      The overall objective of the proposed research is to test the feasibility of using an early~     functional progression program to reduce athletes' time out of sport and improve clinical~     outcomes. Specifically, to pilot altering the rest period in athletes with a spondylolysis~     and begin rehabilitation immediately. These young athletes will return to sport as they are~     able, after demonstrating predetermined pain free functional ability. Twelve young athletes~     with a confirmed active spondylolysis will be recruited to undergo the early function~     progression intervention. The specific aims of this study are to assess the feasibility of~     implementing the immediate functional progression protocol, refine the protocol if necessary,~     and estimate potential effectiveness of this intervention. The athletes' outcomes will be~     compared to historical controls. The investigators hypothesize that the immediate functional~     progression program can be successfully implemented and with only minor changes will be~     suitable for use in larger trials. It is estimated the immediate functional progression~     program has the potential to return athletes to sport more than a month sooner than current~     practice. Once able to demonstrate the feasibility of the early functional progression~     program, the investigators plan to progress this work into larger trials to fully assess~     effectiveness, safety and long-term outcomes.~   "
25205|NCT03237091|"~     Research indicates that increasing brain excitability might help improve hand function in~     people with spinal cord injury. Brain stimulation that uses electrodes placed on the surface~     of the scalp (also called non-invasive brain stimulation) increases brain excitability and~     has the potential to make it easier for the brain and nervous system to respond to arm and~     hand training. The purpose of this study is to compare four different types of stimulation~     for increasing brain excitability to determine which types are best for helping people with~     tetraplegia improve their ability to use their arms and hands. To fully evaluate the value of~     brain stimulation on arm and hand function, the investigators will also evaluate the effect~     of sham (fake) stimulation. Each participant will receive a single session of each of the~     five types of stimulation being tested.~   "
25206|NCT03237078|"~     Recent studies have suggested that gut-brain axis may be one of the mechanisms of major~     depression disorder (MDD). In animal studies, alteration of gut microbiota can affect~     animal's depression or anxiety-like behavior, brain neurochemistry and inflammation. In human~     studies, the composition of gut microbiota is different between patients with MDD and healthy~     controls. In addition, supplementation of probiotics can improve mood status in community and~     clinical participants. Inflammation is one of possible pathway to connect gut and brain. Gut~     permeability and inflammation level are higher in patients with MDD. Lactobacillus plantarum~     PS128 in one of bacteria extracted from traditional fermented food, Fu-Tsai. It can alleviate~     depressive-like behavior reduce inflammation level in maternal separation mice. This study is~     an 8-week open trial to investigate the effects of Lactobacillus plantarum PS128 on~     psychophysiology in patients with MDD and higher level of inflammation.~      This is a two-phase study. In the first phase, we will recruited patients fulfilling the~     following inclusion criteria: Age 20-65; fulfill Diagnostic and Statistical Manual of Mental~     Disorders fifth version (DSM-V) criteria of major depressive episode in recent 2 years;~     Psychotropics including antidepressants, antipsychotics and hypnotics have been kept~     unchanged for at least 3 months. The exclusion criteria are: comorbid with schizophrenia,~     bipolar disorder, or other substance use (except tobacco) disorder; having active suicidal or~     homicidal ideation; known allergy to probiotics; comorbid with hypertension, diabetes~     mellitus, irritable bowel syndrome, inflammatory bowl disease, liver cirrhosis, or autoimmune~     diseases; known active bacterial, fungal, or viral infections in one month; use of~     antibiotics, steroid, immunosuppressants, probiotics, or synbiotics in the month before~     collecting blood and fecal samples; pregnant or lactating women; who state to have dietary~     pattern changed or in diet within previous two months. Those hs-CRP > 3 mg/L in the first~     screen will be invited into the second phase intervention. In the second phase intervention,~     we will give eligible patients Lactobacillus plantarum PS128 for 8 weeks, and compare~     depression symptoms, gut microbiota, gut inflammation and permeability, and serum~     inflammation level before and after intervention.~   "
25207|NCT03237065|"~     Treatment with iron isomaltoside and ferric carboxymaltose in subjects with iron deficiency~     anaemia and comparison of the incidence of hypophosphatemia.~   "
25208|NCT03237052|"~     This multi-centre study will evaluate the clinical efficacy of 3 atypical antipsychotics~     treatment in Chinese Patients with Schizophrenia by comparing model-decision with real-world~     psychiatrist-decision. The three atypical antipsychotics are olanzapine (5-20 milligram per~     day), risperidone (2-6 milligram per day) and aripiprazole (5-30 milligram per day). The main~     purpose of this study is to explore the potential difference between modal-aided-decision~     with clinician-decision in order to validate and optimize the selection model that has been~     established in advance.~      The efficacy evaluations include symptoms, social function, recurrence rate and~     hospitalization. Visits occurs at 0, 4, 8, 13, 26, 52 weeks.~   "
25232|NCT03236727|"~     Intravenous anesthetic agents as far as inhaled agents produce a dose depended increase in~     latency and decrease in amplitude of SomatoSensory Evoked Potential (SSEP). Dexmetedomidine,~     a highly selective a2 adrenergic agonist, not only minimizes the anesthetic agents but also~     the opioids, reducing the analgesic demands. The effect of dexmedetomidine on SSEP has not~     been elucidated. We aimed to investigate alterations on somatosensory SSEP in adults during~     posterior spinal fusion surgery before and after Dexmedetomidine administration.~   "
25233|NCT03236714|"~     Preoperative fasting is mandatory for anesthetic induction. This period of fasting is~     probably greater due to delays in the surgical theater and changes in daily operation~     schedules.Investigators want to resarch between the prescribed and the actual preoperative~     fasting time.~   "
25209|NCT03237039|"~     Principal aim The main purpose of the study is to describe the distribution of the sagittal~     profile in elderly subjects in order to bridge the gap present in this type of screening,~     evaluated in the literature for adults only (i.e. 160 subjects considered by Roussouly et al.~     in 2005). This classification assigns an integer value from 1 to 4 in relation to the~     evaluation of alignment of the lumbar spine and pelvis in the sagittal plane. The population~     description is therefore divided into four categories. The extension of this classification~     to elderly can provide useful support for the clinical evaluation and the specific treatment~     of the elderly patients.~      Secondary aims The study aims in addition to evaluate the relation between the spine sagittal~     profile and the objective indexes obtained from the assessment of fall-risk and gait cycle~     analysis. Accordingly, a subgroup of 40 subjects out of the 160 will be evaluated. This~     subgroup will consider the subjects older than or equal to 74 years, where the risk of~     falling is most likely to be expected.~   "
25210|NCT03237026|"~     Prostate cancer (PC) afflicts millions of men worldwide. In Taiwan, around 5,000 men are~     diagnosed as PC while 1,200 men die of the disease each year. Although there is a significant~     advance in the definitive treatments of PC, the failure rate is still up to 40%. Androgen~     deprivation therapy (ADT) and chemotherapy (Chemo) are palliative and rarely curative.~     Immunotherapy brings on promise but is highly unpredictable. Thus, markers that predict~     treatment outcomes may help decision making and prompt early adjuvant or salvage therapy.~     Also, markers that mediate resistance to treatments may become druggable targets.~      This is a prospective and observational clinical study investigating urine metabolites via~     metabolomics analysis in subjects who will undergo therapy for PC. The treatment modalities~     include radical prostatectomy (OP), prostate radiotherapy (RT), systemic Chemo, and ADT. The~     expected subject number to be enrolled is 360 men from NTUH. There will be 2 cohorts:~     training cohort (Cohort A, N=180), and validation cohort (Cohort B, N=180). Each cohort~     consists of patients treated with OP (N=50), RT (N=70), Chemo (N=30) and ADT (N=30). Cohort A~     will be recruited in the first 12 months of the study period to generate the first batch of~     urine metabolite profiles. Cohort B will be recruited in the second half of the study period~     to validate the first batch of newly developed urine metabolite profile.~      Pre-treatment and post-treatment clinic-pathological parameters will be recorded. Group~     specific urine metabolite profiles will be constructed by comparing the outstanding~     metabolites between groups. These metabolite profiles are constructed so as to efficiently~     separate outcome groups, especially to predict subjects with good prognosis and response to~     the treatment. The newly constructed metabolite profiles will be validated against another~     cohort of subjects who will receive therapy for PC to determine the predictive efficiency of~     the constructed profiles. In addition, paraffin blocks of the prostate cancer will be used to~     identify progression markers for invasion and metastasis, as well as progression markers for~     castration-resistant PC.~      Through a better understanding of the biology of PC, we hope to develop new markers/targets~     for more effective predicting outcomes of PC. In the meantime, we can also substantially~     develop a better decision-making tree of PC.~   "
25211|NCT03237013|"~     The purpose of the intended proposed research is to investigate and determine best strategies~     for preventing skin cancer for emerging adults. To answer this question, the investigators~     intended to pilot a randomized control trial with three arms: 1) Facial Morphing, 2)~     Mindfulness, and 3) Treatment as usual. The population from which the sample was drawn from~     was undergraduate psychology students from a large public university in Southern California,~     who report recent indoor/outdoor tanning, and intentions for future tanning.~   "
25212|NCT03237000|"~     Admission CTG for 20 minutes Settings on a CTG machine was standardised to enable a~     consistent approach of interpretation of traces. Paper speed of 3cm per minute will be~     adopted. Maternal heart rate was recorded and noted on CTG. Following birth date, time and~     mode of delivery will be labelled on CTG.~      Magnesium sulphate was administered by continuous intravenous infusion according to our~     hospital protocol as follows:~        -  Loading dose: 4-6 gm of magnesium sulphate diluted in 100 mL of IV fluid administered~          over 15-20 min.~        -  Maintenance dose: 2 gm/hr in 100 mL of IV infusion to be continued for 24 hours after~          delivery.~      Another 20 minutes CTG strip will be performed 20 minutes after administration of IV loading~     MgSO4, 7H2O and thus ensuring that MgSO4 has reached peak serum levels~   "
25213|NCT03236987|"~     MAC lung infections are a growing public health problem. The ATS / IDSA 2007 guidelines for~     the treatment of these non-tuberculous mycobacterial infections recommend the use of a~     macrolide or azalide (clarithromycin or azithromycin), rifampicin or rifabutin and~     ethambutol.~      For MAC disseminated infections, several studies have compared combinations containing~     clarithromycin or azithromycin and found no significant difference in efficacy. No randomized~     controlled trials have been performed for pulmonary infections to compare clarithromycin and~     azithromycin in terms of efficacy. Clarithromycin is often used as a first-line treatment in~     France, but its tolerance is often poor, particularly in terms of risk of hepatitis, metallic~     taste in the mouth, nausea or vomiting, and it interacts with many drugs via cytochrome p450~     . In particular, it increases the toxicity of rifabutin, in particular in terms of uveitis.~     Azithromycin has fewer side effects especially less digestive toxicity and drug interactions~     than clarithromycin.~      The hypothesis is therefore that the efficacy of azithromycin would be non-inferior in~     comparison with that of clarithromycin.~   "
25214|NCT03236974|"~     This is an open label randomised multicentre pre-surgical pharmacodynamics study to compare~     and assess the biological effects of AZD9496 and fulvestrant in postmenopausal women with~     estrogen receptor (ER) positive (ER+), human epidermal growth factor receptor 2 (HER-2)~     negative (HER2-) primary breast cancer.~      Patients will receive AZD9496 or fulvestrant and will have an on-treatment image~      -guided core biopsy after 5-14 days of commencing treatment.~   "
25215|NCT03236961|"~     Appendicectomy has been the treatment of acute appendicitis for over a hundred years.~     Appendicectomy, however, includes operative and postoperative risks despite being a routine~     procedure. Several studies have proved promising results of the safety and efficiency of~     antibiotics in the treatment of acute uncomplicated appendicitis. The APPAC study by the~     investigators, published in 2015 in the Journal of American Medical Association, also proved~     promising results with 73% of patients with uncomplicated appendicitis treated successfully~     with antibiotics. None of the patients initially treated with antibiotics that later had~     appendectomy had major complications. The results of the APPAC trial suggest that CT proven~     uncomplicated acute appendicitis is not a surgical emergency and antibiotic therapy is a safe~     first-line treatment option. Reducing unnecessary appendectomies has also been shown to lead~     to significant economic savings.~      The aim of this randomized prospective study is to optimize antibiotic therapy for~     uncomplicated acute appendicitis by comparing different antibiotic regimens; intravenous~     antibiotic (ertapenem) followed by per oral antibiotic (levofloxacin and metronidazole) with~     only per oral antibiotics (moxifloxacin). Before randomization, the diagnosis of acute~     uncomplicated appendicitis is confirmed with a CT scan.~      The hypothesis is that broad-spectrum intravenous antibiotics requiring additional hospital~     resources are not necessary for the treatment of uncomplicated acute appendicitis and that~     per oral mono therapy is non-inferior to the combination of intravenous and per oral~     antibiotic therapy.~   "
25217|NCT03236935|"~     The purpose of this Phase Ib study is to test the safety of NG-monomethyl-L-arginine (L-NMMA)~     and pembrolizumab when used together in participants with melanoma, non-small cell lung~     cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), classical Hodgkin lymphoma~     (cHL), urothelial carcinoma, or microsatellite instability-high (MSI-H)/mismatch repair~     deficient (dMMR) cancer. Pembrolizumab is a type of treatment that stimulates the immune~     system to attack cancer cells. The immune system is normally the body's first defense against~     threats like cancer. However, sometimes cancer cells produce signals like programmed death-1~     (PD-1) that prevent the immune system from detecting and killing them. Pembrolizumab blocks~     PD-1 so your immune system can detect and attack cancer cells. To help further boost the~     cancer-fighting ability of your immune system, L-NMMA will be used along with pembrolizumab.~     L-NMMA is a nitric oxide synthase inhibitor. The presence of nitric oxide synthase in the~     area around the cancer cells blocks the cancer-fighting ability of the immune system. Thus,~     the use of L-NMMA and pembrolizumab together may make the immune system work harder to attack~     and destroy the cancer cells.~   "
25218|NCT03236922|"~     It is clear from multiple accounts in the literature that patients with a vesico-vaginal~     fistula (VVF) involving the bladder neck and/or proximal urethra have a high likelihood of~     residual incontinence. Performing subsequent surgeries after the initial VVF repair risks~     additional complications. Therefore, placement of an autologous sling at the time of initial~     VVF repair would not only assist in covering the fistula, but would also imitate the~     physiologic support that would theoretically improve urethral function. A rectus fascia sling~     would most naturally provide this support and warrants testing against the success of the PC~     sling.~      Using the Goh scoring criteria, Goh class 3 and 4 VVF's are the type most involving the~     urethra. Therefore, this group of patients is the target population for this study. As there~     is currently no standard of care for repairing large urethral defects, this procedural~     technique combined with otherwise standardized fistula repair would not introduce any~     foreseeable harm to patients.~   "
25219|NCT03236896|"~     A prospective randomized pragmatic trial will be used to obtain data on energy expenditure,~     temperature changes and vasomotor symptoms at baseline, during the intervention in which~     participants will be randomized to either exercise or to not exercise, and at the end of the~     12-week intervention.~   "
25220|NCT03236883|"~     To evaluate the safety and efficacy of non-myeloablative hematopoietic stem cell~     transplantation in the treatment of pancreatic cancer.~   "
25221|NCT03236870|"~     The objective of this non-interventional, observational study is to assess the effectiveness~     and patient reported outcome of adalimumab in patients with moderate to severe psoriasis in~     real world clinical practice in China.~   "
25222|NCT03236857|"~     An open-label, global, multi-center study to evaluate the safety and pharmacokinetics of~     venetoclax monotherapy, to determine the dose limiting toxicity (DLT) and the recommended~     Phase 2 dose (RPTD), and to assess the preliminary efficacy of venetoclax in pediatric and~     young adult participants with relapsed or refractory malignancies.~   "
25223|NCT03236844|"~     The purpose of this study is to assess the relative bioavailability of the high concentration~     liquid formulation (HCLF) of gantenerumab produced with the G4 process in comparison to the~     same HCLF of gantenerumab produced with the G3 process in healthy participants following~     single SC dose administration.~   "
25224|NCT03236831|"~     The investigators are doing this research to find out if more careful assessment and~     elimination of potential risk factors of acute kidney injury (AKI) during the subject's~     perioperative period will reduce their chance of kidney damage and kidney damage related~     problems.~   "
25225|NCT03236818|"~     In this prospective long term feasibility study we examine whether a goal oriented~     therapeutic strategy that is able to preserve right ventricular function will result in~     improved clinical outcome in patients with pulmonary arterial hypertension. We hypothesize~     that right ventricular function can only be preserved when early and aggressive medical~     combination therapy not only reduces pulmonary vascular resistance but also pulmonary~     pressures.~   "
25226|NCT03236805|"~     This is a prospective, randomized, single-blind trial evaluating prehospital patients~     experiencing moderate to severe acute pain, defined as a numeric rating scale score greater~     than or equal to 5. Patients will be randomized to receive ketamine at or morphine by~     intravenous push.~   "
25227|NCT03236792|"~     Light chain (AL) amyloidosis is a bone marrow disorder that affects a wide range of organs~     that can lead to organ dysfunction and death. Amyloid is an abnormal protein that is produced~     in your bone marrow and cannot be broken down. It builds up in different organs preventing~     them from working well. The most commonly affected organs are the kidneys, heart, liver,~     spleen, nervous system, and digestive tract. Treatment with chemotherapy can stop the growth~     of abnormal cells that produce this abnormal protein. Decrease in amyloid protein in the body~     improves the function of the affected organs.~      The primary purpose of this study is to determine the safest dose of the medications and how~     well you tolerate them or the maximum tolerated dose (MTD). The study uses Ixazomib in~     combination with cyclophosphamide and dexamethasone to treat people with newly diagnosed AL~     amyloidosis. This combination of medications is an oral regimen that is taken over 6 cycles.~     The first part of study will determine the safety of this regimen and the second part of the~     study will determine how effective this combination of drugs is to treat your disease.~   "
25228|NCT03236779|"~     This is a clinical trial that will be done in the state of Kuwait, at the physical~     rehabilitation medicine hospital. the participants will be recruited from all over Kuwait,~     there is a clinical registry upon the ethical committee in Kuwait assigned by the ministry of~     health.~   "
25229|NCT03236766|"~     This study will enroll 100 Samoan and 100 Marshallese adults to discuss mental health, mental~     disorders, and approaches for engaging Pacific Islander adults with mental illness into~     mental health services.~   "
25230|NCT03236753|"~     This clinical trial is designed to evaluate the efficacy and safety of thread-embedding~     acupuncture for treatment of lumbar herniated intervertebral disc (L-HIVD) by assessing pain,~     function, and quality of life.~   "
25231|NCT03236740|"~     This study is undertaken to compare the effects of treatment with commonly used OCP~     containing ethinylestradiol-cyproterone acetate and metformin in women with PCOS. Special~     attention will be paid to changes in ovarian stromal blood flow by using Color Doppler and~     they will be correlated with changes in hormonal parameters post-treatment.~   "
25237|NCT03236662|"~     This is a 48-week open-label extension of our initial proof-of-concept study (UCD0113) in~     patients with Becker muscular dystrophy who participated in the earlier trial. This single~     center study will enroll up to 10 adults who will receive the purified nutritional extract~     (-)-epicatechin 100mg/day orally for 8 weeks. After screening visits, participants will be~     enrolled in the study if they meet all inclusion criteria. They will be evaluated at~     screening, baseline, and weeks 4, 8, 12, 24, 16 and 48. The main criterion for success of the~     study will be presence of one or more biologic or strength and performance outcome measures~     that yield a response magnitude that allows for sufficient power in a Phase II B study with a~     sample size of 30 individuals.~   "
25238|NCT03236649|"~     The primary efficacy index of this study is to compare the OS of the two groups.~   "
25239|NCT03236636|"~     The primary efficacy index of this study is to compare the OS of the two groups.~   "
25240|NCT03236623|"~     Thirst is defined as the desire to drink water. The perception and satiation of thirst~     constitute an interconnected network of neuronal, physiological and hormonal mechanisms that~     act simultaneously. In the oropharyngeal cavity are ionic channels called Transient Receptor~     Potential Melastatin 8 stimulated by cold temperatures and menthol, which aid in the control~     and decrease of the thirst intensity for providing refreshment and satiety without, however,~     the necessity of fluid intake In high amounts.~   "
25241|NCT03236610|"~     Little is known about efficacy of switching to tenofovir monotherapy for multidrug-resistant~     chronic ehpatitis B patients who achieved a complete virological response to entecavir and~     tenofovir. This study aimed to investigate the efficacy of switching to tenofovir monotherapy~     for multidrug-resistant chronic hepatitis B patients with undetectable heaptitis B virus DNA~     while on tenofovir plus entecavir combination therapy.~   "
25242|NCT03236597|"~     The purpose of this study is to:~        1. Evaluate the relative efficacy of a treadmill desk intervention and a sit/stand desk~          intervention on light physical activity and sitting behaviors at work over four weeks;~        2. Evaluate the relative efficacy of a treadmill desk intervention and a sit/stand desk~          intervention on the cardiometabolic risk profiles (composite measure of fasting glucose,~          insulin, triglycerides, HDL-cholesterol, and blood pressure)over a four-week period.~   "
25243|NCT03236584|"~     Little is known about efficacy of switching to tenofovir monotherapy for lam-resistant~     chronic hepatitis B patients who achieved a complete virological response to lamivudine plus~     adefovir. This study was to investigate the efficacy of switching to tenofovir monotherapy~     for lamivudine -resistant chronic hepatitis B patients with undetectable hepatitis B virus~     DNA while on lamivudine plus adefovir combination therapy~   "
25244|NCT03236571|"~     Marfan syndrome (MFS) is a rare genetic disease (1/5000) characterized by the association of~     ocular impairment, cardiovascular disease and musculoskeletal disease.~      In some chronic conditions, physical activity and training have been shown to be effective in~     improving muscle strength and functional abilities but also fatigue and quality of life. We~     hypothesize that the implementation of a personalized exercise rehabilitation program~     (Personalized Training Program) in children and young adults with MFS, by improving muscle~     mass, physical endurance, muscle strength, bone mass and quality of life of these patients.~     In order to test this hypothesis, investigators wish to carry out an interventional,~     prospective, monocentric study for the first time in children and young adults (<25 years~     old) presenting an MFS.~   "
25245|NCT03236558|"~     Regulatory T lymphocytes play a major role in the protection from autoimmune pathology.~     Defects in immunosuppression mediated by these cells is therefore suspected to contribute to~     these diseases. This issue has very little been studied in humans.Regulatory T cells~     emigrated from the thymus will be isolated from the blood of patients and healthy controls.~     The repertoire of antigen-receptors will be analysed by high throughput sequencing and its~     diversity estimated using appropriate statistical models borrowed from ecology.~   "
25246|NCT03236545|"~     The purpose of the study is to identify the independent effect of estradiol (E2) on~     endothelin-1 (ET-1) mediated vasomotor function in women. The study is the first step in~     recognizing the impact of ovarian hormones on the mechanisms that regulate vascular function~     in women to provide a better understanding of the cardiovascular efficacy of hormone therapy.~   "
25247|NCT03236532|"~     This study aimed to investigate the effect of an exercise session with weights associated~     with glutamine dipeptide (GLD) supplementation on cognitive function of people living with~     HIV/ AIDS. The sample consisted of 10 HIV+ women, who used the Antiretroviral Therapy Highly~     Active. The participants were randomized in a double-blind procedure to receive seven days of~     supplementation GLD or placebo (PLA). At the end of this first period, the participants held~     a workout with weights with cognitive assessments before and immediately after the session.~     To evaluate oxidative stress markers blood samples were collected before and 1 hour and 2~     hours after the session.Then the participants rested for 7 days for the initial stocks of~     glutamine return to baseline levels (washout). Following was realized the crossing of the~     groups, so those who had received the GLD in the first week spent extra for 7 days with PLA~     and vice versa, and then they repeated evaluations and exercise session. The exercise session~     consisted of seven resistance exercises involving different muscle groups, with three sets of~     8-12 repetitions with an interval of 90 seconds between sets and 120 seconds between the~     exercises. Stroop test was used to cognitive assessments, which aims to assess selective~     attention and inhibitory control over the color of conflict and word, and the N-back test,~     responsible for evaluating the central executive component of working memory by stimuli~     visual. Oxidative stress markers (TBARS, FOX, GSH, GSSG, AOPP) were analyzed in plasma~     samples.~   "
25258|NCT03236376|"~     Stroke survivors often encounter impairments in the upper limb after stroke. Sensorimotor~     impairments are present in 67% of the stroke patients, resulting in problems with~     independency and performance of activities of daily life. In addition, the pattern of~     recovery in the brain is still a matter of ongoing debate. Although the importance of~     somatosensory function on motor performance is well described, evidence for somatosensory or~     sensorimotor therapy and brain-related changes is scares. Therefore, we aim to explore the~     effect of a sensorimotor therapy compared to pure motor therapy on motor function of the~     upper limb. A second objective is to investigate therapy-induced brain-behavior associations~     using resting state functional Magnetic Resonance Imaging of the brain.~   "
25248|NCT03236506|"~     Hepatitis C is a blood borne virus that can seriously damage the liver. An estimated 50,000~     Scots have been infected with Hepatitis C virus (HCV). The main driver for spread of HCV~     infection is intravenous drug use. As HCV is highly infectious by the blood borne route~     through needle sharing, it can infect the person who injects drugs (PWID) early in their~     habit.~      Around two thirds of people who are infected are unaware of it, and often show no symptoms~     over a long period of time. While there is presently no vaccination for Hepatitis C, improved~     treatments with shorter duration are now available. This raises the possibility of using~     therapy as prevention, turning the epidemic off at source, by targeting active PWID who are~     the main source of new infections. Modelling work illustrates the startling possibility and~     impact of treating drug users to reduce the prevalence of HCV.~      The focus of this trial will be to ascertain whether oral treatment regimens are effective in~     the treatment as prevention scenario in an active PWID population where illicit drug taking~     and poor adherence may reduce treatment efficacy. The investigators will trial 3 different~     methods of delivering treatment and will trial an unlicensed combined treatment against HCV~     genotype 3 infection of shortened duration since current regimens for this genotype are~     limited.~      The investigators will recruit 135 participants and randomise them to one of three arms:~     daily, directly observed therapy; fortnightly dispensing of drugs; fortnightly dispensing of~     drugs with a psychological adherence intervention. Randomisation will be stratified according~     to HCV genotype. Participants will be treated for 12 or 8 weeks depending on genotype and~     followed up 12 weeks post treatment for the measurement of sustained viral response (SVR).~     The primary outcome measure will be SVR at 12 weeks post treatment (SVR12), as this measure~     of cure is the determinant of sufficient compliance and efficacy within the 3 treatment arms.~     Analysis will be by modified intention to treat of all participants who receive one dose of~     therapy, to show non-inferiority fortnightly dispensing is easier to deliver than daily~     dispensing.~   "
25249|NCT03236493|"~     This study is a phase 1 study of PF-06700841. PF-06700841 is being developed for treatment of~     inflammatory bowel disease. The goal of the study is to assess the safety, tolerability,~     pharmacokinetics and pharmacodynamics of PF-06700841 after multiple oral doses of PF-06700841~     in Japanese healthy volunteers.~   "
25250|NCT03236480|"~     Patients with chronic obstructive pulmonary disease (COPD) are 2-3 times more likely to occur~     together with chronic gastrointestinal tract (GIT) diseases, such as inflammatory bowel~     disease (IBD) or irritable bowel syndrome (IBS). Similarly, despite many patients have no~     history of acute or chronic respiratory disease, up to 50% of IBD patients and 33% of IBS~     patients have pulmonary involvement, such as inflammation or impaired lung function.~     Increasing evidence indicated chronic gut and lung disease share key conceptual features with~     the disorder and dysregulation of the microbial ecosystem. However, the underlying mechanisms~     are not well understood.~      Our study is aimed to elucidate the intimate relationship between the gastrointestinal tract~     and respiratory tract, and uncover the mechanisms by which the gut microbiota affects the~     immune responses in the lungs, and vice versa.~   "
25251|NCT03236467|"~     The most recent conflicts are creating a new generation of Veterans, including an increasing~     number of women Veterans, who present with comorbid PTSD and chronic pain conditions,~     including Fibromyalgia (FM), from deployment-related physical injuries and exposure to~     psychological trauma. Health behavior change is important in treating these conditions and~     proactively preventing long-term negative health sequelae, in order to benefit these Veterans~     directly and reduce the challenges to our healthcare system. The proposed SPiRE application~     will use an innovative translational research approach to study whether a progressive -based~     exercise program will reduce FM pain in patients with PTSD and to elucidate and modify~     potential PTSD-related deficiencies in neurobiological and psychological responses to~     exercise to optimize the physical and psychological benefits of exercise for these~     individuals.~   "
25252|NCT03236454|"~     This 2-armed randomized, sham-controlled, single-blind study aims at providing evidence for~     the efficacy of a transcranial direct current stimulation (tDCS)-enhanced cognitive control~     training (PASAT) in participants with subjective cognitive decline (SCD). Overall, the study~     will include 30 participants. Each participant will take part in a four weeks training (12~     sessions); 50% of the participants will receive 2mA anodal tDCS for 20 minutes applied to the~     left dorsolateral prefrontal cortex (dlPFC), the other half will receive sham stimulation.~     Event-related potentials (ERPs) evoked by the feedback on the correctness of the response at~     baseline and after training will be measured with EEG as neurophysiological signatures of~     cognitive control. Near and far transfer will be assessed by a verbal 2-back task and the~     Trail Making Test A and B. The amount of worrying regarding the memory impairment will be~     quantified by means of a 10 point Likert-Scale. Together with changes of PASAT performance~     these measures will be obtained before and after the tDCS-enhanced training. Follow-up~     assessments 3, 12 and 24 months after training will investigate the stability of training~     effects.~   "
25253|NCT03236441|"~     This a prospective, double-blind, sham-controlled, randomized clinical trial to study the~     effects of remote ischemic preconditioning on contrast-induced acute kidney injury, vascular~     and renal biomarkers in patients with non-ST elevation myocardial infarction and unstable~     angina undergoing cardiac catheterization and percutaneous coronary intervention.~   "
25254|NCT03236428|"~     This research study is studying a drug as a possible treatment for Monoclonal Gammopathy of~     Unknown Significance (MGUS) or Smoldering Multiple Myeloma (SMM).~      The drug involved in this study is:~      -Daratumumab~   "
25255|NCT03236415|"~     Stents are used at centers around the world to unblock the arteries of the heart. These~     stents are usually made of metal and remain permanently within the blood vessel wall. Newer~     developments in the stent technology has led to stent scaffolds that can be reabsorbed over~     time. Patients with diabetes are prone to more complex blockages in the heart arteries which~     can be more difficult to treat. The purpose of this study is to compare the difference of how~     arteries heal early when metal stents or resorbable stents are used in patients with~     diabetes.~   "
25256|NCT03236402|"~     A cross - sectional comparative study to assess knowledge and opinion regarding adoption~     among adults residing in rural and urban area of Ambala, Haryana.~   "
25257|NCT03236389|"~     Clinical trials have suggested that this device is effective in mitigating changes in brain~     structure and function in athlete populations. The purpose of the current study is to better~     understand the underlying mechanistic response of the brain hemodynamics to mild jugular vein~     compression~   "
25259|NCT03236363|"~     Project which objective is to test the effectiveness of a classroom-based physical activity~     intervention (MOVI-da10!) on improving, body composition, cardio-respiratory fitness and~     executive function.~   "
25428|NCT03234127|"~     The main objective of SAFIR is to identify the atherosclerotic genetic factors in these~     patients, which will identify new therapeutic targets for the treatment of CV and Familial~     Hypercholesterolemia diseases. In addition, SAFIR will allow the identification of new CV~     protection biomarkers, which will be useful tools for the development of a personalized~     medicine for the management of dyslipidemias.~   "
25260|NCT03236350|"~     Chronic kidney disease (CKD) is one of the leading causes of death and disability in~     Singapore and worldwide. Hypertension is commonly inadequately controlled in patients with~     CKD and this is associated with CKD progression and cardiovascular complications. Daily~     episodes of Remote ischaemic conditioning (termed chronic RIC or CRIC) using transient limb~     ischaemia/reperfusion applied for 1 to 12 months have been shown to lower systemic blood~     pressure (SBP), prevent stroke and reduce post-myocardial infarction left ventricular (LV)~     remodelling in experimental and clinical studies. In the ERIC-BP-CKD feasibility and efficacy~     study, we hypothesise that CRIC administered for 28 days will lower systemic blood pressure~     and improve blood pressure control in patients with CKD and hypertension.~   "
25261|NCT03236337|"~     Project which objective is to test the effectiveness of an extracurricular physical activity~     intervention based on high intensity interval training (MOVI-daFit!) on improving~     cardiorespiratory fitness (CRF), cardiometabolic risk, executive function, and academic~     performance.~   "
25262|NCT03236324|"~     The aim of this study is to assess the efficacy of a bilateral TFP block in parturients~     undergoing cesarean delivery (CD) by evaluating postoperative opioid consumption and numeric~     rated pain scores in two groups (TFP block with saline (control) and TFP block with local~     anesthetic (treatment)). Women (American Society of Anesthesiologists physical status Class~     1-3) at term gestation with singleton pregnancies undergoing an elective CD under spinal~     anesthesia at the South Health Campus will be consented to participate in the study. Patients~     will be randomly assigned using a computer-generated table of random numbers to two groups.~     Group allocations will be concealed. All patients will receive spinal anesthesia with spinal~     Morphine according to our institutional protocol. At the end of surgery, randomized patients~     will receive either ultrasound-guided bilateral TFP blocks with 0.25% bupivacaine with 2.5~     mcg/ml epinephrine 40 ml total or maximum 2.5 mg/kg (Group 1) or 40 mL saline (Group 2) by 2~     anesthesiologists experienced in performing this block.~   "
25263|NCT03236311|"~     The Primary Objective of this study:~      -To assess the effects of SAR407899 on coronary vasomotor function using the coronary flow~     reserve (CFR) in patients with microvascular angina and/or persistent stable angina despite~     angiographically successful elective percutaneous coronary intervention (PCI).~      The Secondary Objectives of this study are:~        -  To assess the effects of SAR407899 on quality of life using Seattle Angina Questionnaire~          physical limitation domain (SAQ-PL) in patients with microvascular angina and/or~          persistent stable angina despite angiographically successful elective PCI.~        -  To assess the safety of SAR407899 in patients with microvascular angina and/or~          persistent stable angina despite angiographically successful elective PCI with a focus~          on identified risks such as hypotension and orthostatic hypotension.~        -  To assess SAR407899 plasma concentrations in microvascular angina patients and/or~          persistent stable angina despite angiographically successful elective PCI.~   "
25264|NCT03236298|"~     At Mount Sinai Hospital, epidural analgesia for labor pain is delivered by programmed~     intermittent epidural bolus (PIEB), in combination with pushes of medication activated by the~     patient, a technique called patient controlled epidural analgesia (PCEA). Studies have shown~     that delivering analgesia in this manner can prolong the duration of analgesia, diminish~     motor block, lower the incidence of breakthrough pain, improve maternal satisfaction and~     decrease local anesthetic consumption comparing to a conventional continuous infusion. The~     use of this PIEB technique in routine practice has reduced the total consumption of local~     anesthetic and the percentage of patients requesting additional boluses (PCEA or manual~     rescues).~      However, at the same time, sensory blocks above those targeted for labor pain relief have~     been reported in our institution, suggesting that the spread of the freezing medication is~     wider than necessary. Based on the information already available in the literature, the~     investigators will conduct this study to determine the best regimen of PIEB achievable with a~     slower delivery speed.~      The hypothesis of this study is that PIEB boluses with 125 mL/h will decrease by 50% the~     incidence of women presenting sensory block to ice equal or higher than T6 as compared to a~     delivery rate of 250 mL/h.~   "
25265|NCT03236285|"~     The study investigates the effects of high intensity interval training (HIIT) versus~     continuous training (CT), combined or not with fasting, on capillary density, microvascular~     function, cardiometabolic risk markers, functional capacity, and quality of life, in~     overweight or obese sedentary women with cardiometabolic risk factors. The use of HIIT could~     promote greater improvements in these parameters than CT. Furthermore, the positive effects~     of exercise may increase when it is performed in the fasting state, compared to exercise~     performed in the fed state.~   "
25266|NCT03236272|"~     The aim of the investigators 'study is to investigate the relationship between the biomarkers~     (e.g. protein markers, genetic polymorphisms and epigenetic markers) and the onset of ARDS.~     In this study, the participants were divided into case group (with ARDS) and control group~     (without ARDS), based on a nested case-control study method. During the diagnosis and~     treatment, the clinical data of subjects are collected at the given time point. And the~     clinical data are extracted from plasma, blood and bronchoalveolar lavage fluid of~     participants. These data will be analyzed based on statistical methods. In the end ,the~     investigators can build a multi index early warning model based on the biomarkers,which is~     meaningful for the early diagnosis of the patient with high-risk for ARDS and provide~     evidence for the early treatment.~   "
25267|NCT03236259|"~     The purpose of this study is to investigate the effects of daily supplementation of Brainport~     for a period of 6 months on cognitive health.~   "
25268|NCT03236246|"~     The objectives of this study are to assess the long-term efficacy and safety of different~     dose regimens of KRX-0502 in the treatment of iron deficiency anemia (IDA) in adult subjects~     with non-dialysis dependent chronic kidney disease (CKD).~   "
25269|NCT03236233|"~     This study investigates the safety, tolerability and pharmacokinetics of single and repeat~     doses of PC786.~   "
25368|NCT03234920|"~     Sarcopenia is an independent predictor of morbidity and mortality in cirrhotic patient before~     and after liver transplantation. Beta-hydroxy-beta-methyl butyrate (HMB) is a leucine~     metabolite with potential efficacy in increasing protein synthesis, muscle mass and its~     functionality.~      The aim of this randomized controlled study is to evaluate the effect of a nutritional~     supplementation with HMB after liver transplantation both on muscle mass and on muscle~     function.~   "
25270|NCT03236220|"~     The aim of the study is to evaluate the efficacy of the prophylactic administration of~     N-acetyl-L-cysteine (NAC) in acute leukemia patients with complete remission pre- and~     post-allotransplant on the occurrence of poor graft function (PGF) and prolonged isolated~     thrombocytopenia (PT) after haploidentical hematopoietic stem cell transplantation.~     Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an effective treatment of~     malignant hematopoietic diseases. However, the delayed hematopoietic reconstitution,~     including PGF and PT, remain serious complication after allo-HSCT, and the effective~     therapeutic strategies are limited. In murine studies, endothelial cells have been identified~     as a key cellular component supporting hematopoietic stem cells in the bone marrow~     microenvironment. Our previous prospective nested case-control study suggested that the~     frequency of bone marrow endothelial cells was markedly reduced in patients with PGF or PT.~     Moreover, our recent study further identified reduced bone marrow endothelial cells (<0.1%)~     pre-allotransplant was associated with significant higher incidences of PGF or PT after~     allo-HSCT. In addition, NAC treatment in vitro could quantitatively and functionally improve~     bone marrow endothelial cells derived from the patients with PGF or PT. Therefore, bone~     marrow endothelial cells (<0.1%) pre-allotransplant can be used to identify patients with a~     higher incidence of PGF or PT to provide timely prophylactic intervention of NAC to prevent~     the occurrence of delayed hematopoietic reconstitution post-transplant. The study hypothesis:~     Prophylactic intervention of NAC pre- and post-allotransplant could reduce the incidence of~     PGF and PT in acute leukemia patients after haploidentical hematopoietic stem cell~     transplantation.~   "
25271|NCT03236207|"~     Infants/children with cow's milk allergy will take part in 2 double-blinded~     placebo-controlled food challenges (DBPCFC) of 2 extensively hydrolyzed formulas in random~     order. If both food challenges are passed, subjects will be asked to consume the Test formula~     in an at-home open challenge for 7 days.~   "
25272|NCT03236194|"~     The investigators will be studying the development of the microbiome over the first year~     after birth in light of various environmental influences - e.g. mode of delivery, diet (and~     diet changes), antibiotic exposure, GERD medication exposure.~   "
25273|NCT03236181|"~     The purpose of this study is to evaluate the effect of dietary fat on satiety (the experience~     of fullness between one meal and the next) and energy metabolism over an extended period of~     time (chronic effects). How dietary fat sources affect satiety, appetite and energy use is~     unclear. The investigators will use a controlled setting for the studies. They want to know~     if the source of dietary fat alters satiety, satiety hormones, and energy expenditure~     responses after consuming different diets.~   "
25274|NCT03236168|"~     This is a pilot study evaluating if treatment for scabies also treats headlice in the same~     community~   "
25275|NCT03236155|"~     The United States constitutes <5% of the world's population but over 80% of the opioid supply~     and 99% of the hydrocodone supply. In 2014, there were 18,893 deaths from prescription drug~     overdose, and orthopaedic surgeons are the third highest prescribing physicians for opioids.~     Surgeons often prescribe opioids to minimize postoperative pain and to reduce the likelihood~     of readmission for pain. Available data suggests that orthopaedic surgeons are the most~     likely physicians to prescribe opioids to Medicare patients, whose opioid prescriptions are~     over 7 times more likely to come from an orthopaedic surgeon than another type of physician,~     but orthopaedic surgeons also had the highest readmission rate for post-operative pain. Many~     studies have investigated the utilization of opioids after surgery to assess surgeon's~     tendencies to overprescribe, demographics of those likely to overuse, and adverse events of~     opioid abusers.~      The primary purpose of this randomized controlled trial is to determine whether prescribing~     fewer opioid pills per prescription reduces the total amount of opioids taken, even while~     allowing equal total opioid availability via increased frequency of prescription~     availability.~   "
25276|NCT03236142|"~     The aim of this study is to answer the question of whether the single anastomosis, 300 cm~     loop, duodenal switch (SIPS) is an equally effective, safe, simpler operation with less~     nutritional and surgical risks than the standard duodenal switch (DS) operation.~   "
25277|NCT03236129|"~     The investigators have previously shown the absence of toxicity of Treg-depleted-DLI and the~     possibility to triggering alloreactivity (GVHD/GVT) in relapsing patients dealing with~     hematological malignancies who had never shown any signs of GVHD after transplant or after~     one or more DLI.~      The Investigators, we plan to demonstrate the benefit of Treg-depleted DLI as compared to the~     reference treatment of relapse in hematological malignancies after allogeneic HSCT which is~     currently based on standard DLI~   "
25278|NCT03236116|"~     This study will examine the effects of almonds consumed by adults with different body fat~     distributions on indices of carbohydrate and lipid metabolism.~   "
25279|NCT03236103|"~     The investigators are doing this research to investigate whether multifaceted preventive~     measures for newly hospitalized ventricular assist device (VAD) patients will reduce the~     Acute Kidney Injury (AKI) occurrence rate, progression and associated complications~   "
25280|NCT03236090|"~     Study Design:~      Double-blind randomized placebo-controlled clinical trial~      Study Duration:~      2 years~      Study Center:~      Single center Hospital de la Santa Creu i Sant Pau, Barcelona~      Objectives:~      To assess the effect of Vivomixx® on neuroinflammation and systemic inflammatory response in~     patients with cirrhosis~   "
25292|NCT03235934|"~     This pilot study aims to evaluate the feasibility of close glucose monitoring and management~     of patients (targeting fasting and pre-meal glucose of 4-7 mmol/L) using state-of-the-art~     flash glucose monitoring (FGM) technology. The glycemic intervention will be personalized~     based on individual blood glucose levels. Although the glycemic interventions used in this~     study include standard medications and methods of glucose monitoring used for patients with~     diabetes, this pilot study will specifically evaluate the feasibility of using these~     approaches in patients with GBM, appreciating their additional medical, functional and social~     challenges.~   "
25293|NCT03235921|"~     Hemorrhagic shock is a pathologic state in which intravascular volume and oxygen delivery are~     impaired. During circulatory failure associated with hypovolemia and low cardiac output,~     redistribution of blood flow caused by increased vasoconstriction results in decreased~     perfusion of the skin.~      Skin temperature and capillary refill time has been advocated as a measure of peripheral~     perfusion.~   "
25281|NCT03236077|"~     Despite decades of physical activity (PA) research on inactive, obese individuals, we have~     not successfully moved the needle on exercise participation in this population. A recent~     review aptly referred to PA recommendations among obese individuals as the public health~     guideline that is (almost) entirely ignored[1]. While we have previously had little~     understanding of why PA rates are so low in this population, Dr. Leone's research uncovered~     two possible explanations: (1) women with obesity are less likely to report enjoying exercise~     and (2) more likely than non-obese women to report exercising only when they are trying to~     lose weight. In order to affect change among obese women, we need interventions that not only~     address disparities in enjoyment and outcome expectations. Programs must also be practical~     and scalable; however, these types of evidence-based programs do not exist within the context~     that people generally exercise (e.g., community centers, gyms). We propose a novel approach~     to increasing exercise participation in this population by focusing on exercise enjoyment,~     increasing appreciation of the proximal benefits of PA rather than focusing on weight, and~     addressing changes to the exercise environment that make it conducive to this population. By~     delivering our intervention in partnership with the YMCA, we not only have the ability to~     make changes to a typical exercise context, but we also ensure that our findings can be used~     to help exercise-focused community organizations implement a scalable, research-tested~     program.~   "
25282|NCT03236064|"~     This study will evaluate the safety and efficacy of PEG 3350 for use in nerve repair.~   "
25283|NCT03236051|"~     The study is aimed to explore the effects of multimodal analgesia consisting of ropivacaine's~     wound infiltration, parecoxib's intravenous injection and oxycodone-acetaminophen tablets'~     oral administration on postoperative pain and rehabilitation after laparoscopic radical~     gastrectomy for patients with gastric cancer.~   "
25284|NCT03236038|"~     Exocrine pancreatic insufficiency (EPI) is the inability of the pancreas to perform a normal~     digestive function. The prevalence of IPE in patients with decompensated hepatic cirrhosis~     (HC) is unknown and most published series are short, old and use a single diagnostic~     technique with potential risk of false positives and negatives. Demonstrating IPE in a~     patient with HC can change their vital prognosis with the indication of pancreatic enzymes~     that can improve their nutritional status and help control their decompensations.~      Objectives: To assess the prevalence of IPE in patients with decompensated CH. To establish~     correlation between fecal elastase and 13C triolein breath test.~      Methodology: Unicentric, transversal study that will be carried out during hospitalization.~     Patients with HC who enter for decompensation and requiere hospitalization will be included~     consecutively. Exclusion criteria will include prior diagnosis of IPE, suspicion of biliary~     obstruction, more than 5 dep / d induced by laxatives or liquid stools.~      The diagnosis of IPE will be made with the combination of two techniques (13C triolein breath~     test and fecal elastase).~      Demographic, epidemiological data, clinical data as well as anthropometric parameters will be~     collected. A blood test will also be done to assess nutritional status and associated~     deficits. A multivariate analysis will be performed to assess the predictive factors of IPE~   "
25285|NCT03236025|"~     This study aims to use a three arms randomized clinical trial study to evaluate the~     effectiveness of a video-led intervention in helping male smokers planning to have a baby in~     Mainland China to quit or reduce the cigarette smoking.~   "
25286|NCT03236012|"~     This project will address a problem that has troubled Service members, Veterans, and~     civilians with amputations for decades, impacting satisfaction with prosthetic use, residual~     limb skin health, and negatively affecting quality of life. Prior research in this area has~     been limited and insufficient. We are confident that improving the evaluation and treatment~     of residual limb hyperhidrosis will reduce the secondary health consequences of amputation~     and will lead to improved quality of life.~   "
25287|NCT03235999|"~     Up to 20 patients with malignant pleural effusions will be interviewed about their~     experiences of having this condition and its management.~   "
25288|NCT03235986|"~     The present study will mainly aim at investigating the safety, tolerability and efficacy of~     different escalating single doses administration of nebulised Curosurf®, in preterm neonates~     with RDS (Respiratory Distress Syndrome) during nCPAP.~   "
25289|NCT03235973|"~     The investigators focused on patients with refractory acute leukemia or MDS and designed a~     phase 1 trial of escalated cladribine doses in the Cla-Flu-Bu RTC regimen using PK-guided~     myeloablative busulfan doses. This scheme allows combining different optimization of RTC~     experienced over years (Flu-Bu RTC, PK-guided myeloablative busulfan doses, a second purine~     analog cladribine) to approach a specific platform to treat refractory diseases.~   "
25290|NCT03235960|"~     Despite numerous techniques for enamel protection, occlusal caries still remains a problem.~     Sealing pits and fissures is considered to be an effective way of preventing caries~     development. Glass-ionomer cements are mainly recommended for pits and fissures sealing for~     two reasons. First, they are less susceptible to moisture which allows their use in~     noncooperable children or in partially erupted teeth where isolation could be a problem, and~     secondly, due to their potential to act as a fluoride reservoir making enamel more resistant~     to demineralisation. The purpose of the study is to clinically examine the caries-preventive~     effect of a glass-ionomer material for fissure protection in newly erupted permanent molars~     in children with low, moderate, and high caries-risk.~   "
25291|NCT03235947|"~     A clinical controlled, randomized and double blind trial that included adult patients (≥18~     years) receiving kidney transplantation (KT) at the INCMNSZ.~      The intervention group will receive disodium fosfomycin 4 g intravenously in three moments:~     preoperative of transplant surgery, prior to removal of the urinary catheter and finally~     prior to removal of ureteral catheter. The control group will receive placebo in the same~     moments.~      Both groups will receive prophylaxis standard for urinary tract infection (UTI), with~     trimethoprim/sulfamethoxazole 160/800 mg per day. This prophylaxis will be administered once~     the estimated glomerular filtration rate is greater than 30 mL/min/1.73m2.~      The primary objective is to compare the average number of episodes of UTI´s and asymptomatic~     bacteriuria in both groups after 7 weeks of follow-up. The secondary objectives are to know~     the incidence of asymptomatic bacteriuria, the incidence of hospitalizations for IVU, the~     days of hospital stay, the pattern of bacterial resistance, the safety of disodium~     fosfomycin, and assessment of the function of the graft and rejection rate.~   "
25294|NCT03235908|"~     An acute psychotic episode is a severe psychiatric syndrome which might occur in different~     psychiatric diagnoses.~      The outcome prediction of relapse rate of a psychotic episode within a certain time frame is~     difficult and depends on many factors. More and better predictors are required to improve the~     outcome prediction in order to adjust therapy and follow-up if patients suffer from this~     acute disease.~      Copeptin, a surrogate marker for vasopressin, has been proven helpful in the prediction of~     the outcome in serious somatic diseases. Additionally, a rise of copeptin due to~     psychological stress was shown.~      The aim of this study is to investigate the association of the neuroendocrine biomarker~     copeptin and the prediction of the onset of psychotic episode within one year.~   "
25295|NCT03235895|"~     A randomized controlled Trial to evaluate the internet based CME for wet cupping providers in~     Saudi Arabia~   "
25296|NCT03235882|"~     The aim is to validate a FTIR spectroscopy test for measuring lung maturity/Respiratory~     Distress Syndrome (RDS) in terms of safety, usability, and efficacy.~      The purpose is to accurately predict RDS using Lecithin/Sphingomyelin ratio (L/S ratio~     determined by a rapid FTIR test on fresh gastric aspirates) using retrospective analysis.~      Research question:~      In very preterm newborn infants with (risk of) respiratory distress who have not received~     prophylactic surfactant: does analysis of L/S-ratio in fresh gastric aspirates using a rapid~     FTIR test predict RDS requiring exogenous surfactant with sufficient specificity and~     sensitivity to be clinical useful?~   "
25297|NCT03235869|"~     This is a single arm, single stage pilot study of radiation therapy plus durvalumab for~     tumor-stage cutaneous T-cell lymphoma (CTCL).~   "
25298|NCT03235856|"~     The purpose of this study is to create a database of keratoconic eyes with two or more~     corneal topographies/tomographies, at least 5 months apart~   "
25299|NCT03235843|"~     The ADAPTION trial is an investigator initiated prospective randomized doubleblind cross-over~     pilot study in a multi-center setting.~      Aim: to assess the ability of minute ventilation (MV) sensor driven rate adaptive atrial~     stimulation to restore functional capacity and quality of life in heart failure patients with~     chronotropic incompetence.~      Methods: heart failure patients (left ventricular ejection fraction ≤35% & New York Heart~     Assessment II or III) who were implanted with a 2-chamber implantable cardioverter~     defibrillator (ICD) device equipped with a MV sensor that are diagnosed with chronotropic~     incompetence will be included in the study. Patients will be randomized in a 1:1 fashion to~     rate responsive pacing (MV sensor only) function ON (AAIR mode) or OFF (DDI mode). After 3~     months the pacing mode will be switched to the opposite mode.~   "
25300|NCT03235830|"~     The overall goal is to assess the feasibility and effectiveness of using text messages as an~     educational tool in order to improve health care utilization among the parents and caregivers~     of newborns; in particular, the investigators seek to understand how educational text~     messages counteract the effects of low health literacy as it relates to non-urgent visits to~     the emergency department.~   "
25301|NCT03235817|"~     The purpose of this research study is to compare difference between breathing by oneself or~     with the partial help from an anesthesia machine in infants under general anesthesia.~      Hypothesis: Infants undergoing general anesthesia with a PLMA™ will be better ventilated~     (improved breathing) with the help of the breathing machine versus breathing on their own.~   "
25302|NCT03235804|"~     This study will investigate the impact of a 12-week higher protein diet on inflammatory,~     metabolic, and hormonal markers of obesity-associated conditions and to correlate this~     response to compositional shifts within the gut microbiota. Moreover, resting energy~     expenditure, body composition, appetite sensations and soy metabolomics will be explored.~      This study will be a randomized, parallel group, clinical trial of a 12-week nutritional~     intervention. A sample size of n=78 participants will be randomly allocated into one of the~     following groups:~        -  Control group (CON): Participants will be asked to maintain their usual dietary intake~          over 12 weeks. Their usual dietary intake is expected to reflect the North American~          dietary pattern (i.e. ~15% of total energy intake coming from protein, ~50% from~          carbohydrate and ~35% from fat).~        -  High-protein group (HP): Participants will be asked to maintain their usual dietary~          intake and consume a nutritional supplement composed of soy protein, honey and yogurt~          twice daily (in two snacks) over 12 weeks. The addition of the nutritional supplement to~          a North American Dietary Pattern (described on the CON group diet) will result in a diet~          composed of, approximately, 22% of protein, 48% of carbohydrate and 30% of fat of total~          energy intake.~      The following variables will be analyzed:~        -  Interleukin (IL)-6.~        -  Gut microbiota diversity and composition, specifically taxa that have been associated~          with health benefits, obesity, and weight loss.~        -  Systemic inflammatory biomarkers (high-sensitivity C-reactive protein, IL-8, IL-10 and~          tumor necrosis factor-α);~        -  Metabolic blood markers (glucose, insulin, lipid panel, peptide tyrosine-tyrosine,~          glucagon-like peptide-1, ghrelin, adiponectin, leptin, free glycerol, free fatty acids,~          and thyroid stimulating hormone)~        -  Resting energy expenditure;~        -  Body composition;~        -  Appetite sensations (hunger, satiety, fullness, and prospective food consumption);~        -  Soy polyphenols' metabolomics. At baseline and after 6 and 12 weeks, individuals will~          attend our Human Nutrition Research Unit where all assessments will take place. In order~          to assess participants' adherence and follow-up, dietary intake, body weight and~          appetite sensations (only for participants assigned to the HP group) will be assessed~          weekly during the 12-week intervention period. Additionally, participants will be~          contacted by phone weekly and reminded to maintain their journal/log.~   "
25303|NCT03235778|"~     1. To evaluate the tolerances of healthy subjects treated with Felbinac Trometamol~          Injection on multiple dose and single dose~        2. To evaluate the pharmacokinetic characteristics in healthy subjects treated with~          Felbinac Trometamol Injection on multiple dose and single dose~   "
25304|NCT03235765|"~     Molecular profiling of lung cancers using circulating tumor DNA (ctDNA) in the blood of~     patients is rapidly becoming established as a useful source of information to aid clinical~     decision-making. This study is aimed to to compare concordance rate between tissue based~     cancer panel analysis and blood based cancer panel analysis in lung cancer patients (both by~     NGS technique).~   "
25305|NCT03235752|"~     This is a multicenter, randomized, double-blind, placebo-controlled phase II study.~   "
25306|NCT03235739|"~     The purpose of this study is to find out whether oral Naloxegol can reduce the side effects~     of opioid painkillers following surgery. This study aims to explore whether Naloxegol can~     similarly reduce opioid-induced side effects in post-surgical patients. About 130 surgery~     patients will participate in this study which is being conducted at Cleveland Clinic Main~     Campus.~   "
25336|NCT03235349|"~     This is a Phase 3, single-arm, open-label, multicenter study to evaluate the efficacy and~     safety of ABT-493/ABT-530 in chronic hepatitis C virus (HCV) genotype (GT)1 to GT6-infected~     Asian participants with compensated cirrhosis with or without Human Immunodeficiency Virus~     (HIV) co-infection who are HCV treatment-naïve or treatment-experienced with interferon (IFN)~     (alpha, beta or pegylated interferon [pegIFN]) with or without ribavirin (RBV) OR sofosbuvir~     with RBV with or without IFN.~   "
25307|NCT03235726|"~     This single and repeat increasing dose study will collect information on safety, tolerability~     and drug levels in the body of the CCI15106 inhalation powder. The study will also look at~     the level of CCI15106 that will be released into the air and may be found in the blood of the~     people standing around the person inhaling it (bystanders). This is a two-part study in which~     Part 1 will enroll healthy subjects and look at environmental and bystander exposure and Part~     2 will enroll subjects with moderate COPD. Approximately 36 healthy subjects and~     approximately 22 subjects with COPD will be randomized in this study for dosing. The total~     study duration will be 82 days for Cohort A Part 1; 75 days for Cohort B Part 1 and Cohort C~     Part 1; 77 days for Cohort A Part 2; and 90 days for Cohort B Part 2.~   "
25308|NCT03235713|"~     The study aims to (1) evaluate the effectiveness of the recent renewal of tobacco health~     warnings (HWs) on noticing and anti-smoking responses, and (2) assess the effect of exposure~     to point-of-sale (POS) tobacco displays and smoking hotspots on nicotine-craving intensity~     and smoking-related behaviors. The study will use time-based system-triggered ecological~     momentary assessments to collect real-time data about exposures to smoking-related cues and~     behaviors. With a smartphone app installed in the mobile phones of the participants, they~     will each day complete at least 3 pairs of EMA prompted randomly for only 2 days (a working~     and a nonworking day). Outcomes include exposure and responses to tobacco HWs, exposure to~     POS tobacco displays, exposure to smoking hotspots and smoking and quitting outcomes.~   "
25309|NCT03235700|"~     Little is known about the hyperemic efficacy of IV adenosine as well as safety in patients~     with heart failure with reduced ejection fraction (HFrEF) because they were excluded from the~     major FFR studies. We will evaluate the feasibility and hyperemic efficacy of IV adenosine in~     patients with HFrEF in comparison with IC nicorandil for invasive physiological assessment~     using a coronary pressure wire.~   "
25310|NCT03235687|"~     The purpose of this research study is to investigate the utility of a validated urine test~     which predicts the likelihood of high grade prostate cancer on an initial prostate biopsy.~   "
25311|NCT03235674|"~     This study will evaluate the effect of brief, intermittent stair climbing exercise on key~     cardiovascular and metabolic markers of health in individuals completing a cardiac~     rehabilitation program. Participants of this study will be placed into one of two exercise~     groups: one group will perform the standard exercise protocol currently being used by the~     Cardiac Health and Rehabilitation Centre at Hamilton General Hospital and the second group~     will perform a variation of interval exercise training, high intensity interval stair~     climbing.~   "
25312|NCT03235661|"~     The investigators compared advantages and disadvantages of two forms of noninvasive~     respiratory support —bi-level positive airway pressure(BiPAP) or nasal continuous positive~     airway pressure (nCPAP) —as a primary mode of ventilation in preterm twins infants with~     respiratory distress syndrome~   "
25313|NCT03235648|"~     Evaluation of surgical excision of cardiophrenic lymph nodes in patients with advanced~     ovarian cancer~   "
25314|NCT03235635|"~     This is single center study. The investigators will try to know that relationships between~     intestinal microbiome and mortality in preterm infants and what relationships is between~     intestinal microbiome in preterm infants and morbidity, mortality.~   "
25315|NCT03235622|"~     A single center cohort which enrolled women who performed mammography, bone densitometry~     (DEXA), and coronary CT angiography in Seoul National University Bundang Hospital from March~     2011 to February 2013.~   "
25316|NCT03235609|"~     comparison between propofol-fentanyl and propofol-ketamine for sedation in pediatric~     diagnostic gastrointestinal endoscopy.~   "
25317|NCT03235596|"~     It's an interventional, prospective and monocentric pilot study concerning adult patients~     with autism without mental retardation.~      The primary outcome is to assess the effects of cathodal transcranial direct current~     stimulation (tDCS) on the left dorsolateral prefrontal cortex (DLPFC) on the executive~     functions of patients with autism without mental retardation or with Asperger syndrome.~      The secondary outcomes are to evaluate the safety of this treatment and to evaluate its~     impact on impaired social communication and on restricted or repetitive behaviors.~   "
25318|NCT03235583|"~     In this study, the investigators propose to assess the validity in measuring physical~     activity (PA) of a new PA monitor system the MOTIONPODTM, that coupled a hip-worn~     multi-sensor device (associating a tri-axial accelerometer, a magnetometer and a gyroscope)~     with an automatic activity/posture recognition algorithm and an activity-specific multilinear~     prediction model. The MOTIONPODTM performances in predicting mean daily PA energy expenditure~     (PAEE) will be calculated against the reference PAEE gold standard measure, using the doubly~     labeled water method (DLW). The MOTIONPODTM performances in predicting PAEE and PA patterns~     will be compared to those of two existing activity or movement monitors: the triaxial~     accelerometer ActigraphGT3X+TM and a device combining cardiofrequencemetry with~     accelerometry, the ActiheartTM. This latter has demonstrated fair performances but at the~     cost of a calibration of the heart-rate/EE relationship that limits its use in large~     population samples. Briefly, this open study will include 120 subjects, aged 18 to 75 years~     of both gender and with broad range of body mass index and physical activity level. The~     subjects will carry a MOTIONPODTM, an ActigraphGT3X+TM, an ActiheartTM and a GPS for a total~     of 14 days in everyday life conditions and complete a physical activity diary. In half of the~     subjects, PA will be evaluated on a period of 14 days, with standard PAEE measured by DLW.~     The other 60 subjects will be studied twice, one month apart, to test the reproducibility of~     the measures.~   "
25319|NCT03235570|"~     The purpose of this study is to evaluate the safety and tolerability of INCB054828 in~     Japanese subjects with advanced malignancies.~   "
25320|NCT03235557|"~     Robotic Stereotactic Radiation treatment of prostatic adenocarcinoma of the elderly.~      Inclusion criteria : T1-T3b, MRI pelvic nodes negative, M0, any Gleason Score, PSA (Prostate~     Specific Antigen) <30ng/ml.~      Dose : 36.25 Gy in 5 fractions, in 10 days, considering CAPRA Scores≤5 AND 37.5 Gy in 5~     fractions, in 10 days, considering CAPRA Scores>5.~      Primary objective : acute and late toxicity evaluation at 36 months. Secondary objectives :~     PSA and MRI response.~   "
25321|NCT03235544|"~     This is a Phase 2, open-label, 2-cohort study designed to evaluate the efficacy and safety of~     2 INCB050465 treatment regimens in subjects with relapsed or refractory mantle cell lymphoma~     (MCL) previously treated either with or without a Bruton's tyrosine kinase (BTK) inhibitor.~   "
25322|NCT03235531|"~     Alcohol use disorder, or heavy drinking, is commonly seen in patients who present to trauma~     centers. These patients are at risk for Alcohol Withdrawal Syndrome (AWS), which is~     collection of symptoms that can range from anxiety and restlessness to seizures, delirium and~     even death. The Clinical Institute Withdrawal Assessment (CIWA) tool is routinely used to~     assess alcohol withdrawal symptoms. Benzodiazepines (BZD) are commonly administered to trauma~     patients who exhibit symptoms of AWS based on the CIWA scoring system. Although these~     medications have proven efficacy, they can also have negative side effects which may affect~     recovery. Valprate (VPA) is a medication which may have efficacy in management of AWS~     symptoms, thus ameliorating or preventing the need for BZD administration. This trial will~     study the effectiveness of VPA in the prevention of AWS symptoms by comparing the amount of~     BZD use in trauma patients who receive BZD treatment as indicated by CIWA scores with~     patients who receive prophylactic VPA therapy in addition to BZD as indicated by CIWA scores.~   "
25323|NCT03235518|"~     The purpose of this study is to conduct formative research to inform the design and~     implementation of combination prevention interventions, including pre-exposure prophylaxis~     (PrEP) for female sex workers (FSW), as well as to inform recruitment and retention~     strategies for female sex workers and their male clients in Kenya.~   "
25324|NCT03235505|"~     Abstract Rationale. Electronic cigarette use is increasing at an exponential rate in Finland~     and internationally. The health consequences of vaporised aerosols in electronic cigarettes~     are largely unknown especially in a long run. Still, very few studies are available on~     quitting attempts with e-cigarettes as a smoking cessation tool compared to evidence based~     cessation pharmacotherapy in adult smokers who want to quit.~      Research Objective: To investigate effectiveness and safety of e-cigarettes for smoking~     cessation in middle-aged smokers, and to compare the effectiveness of them to varenicline.~     Our study provides new information of success in smoking cessation among heavy adult smokers~     for clinicians.~      Design: A double-blind, randomised, placebo-controlled clinical trial with the intervention~     phase of 12 weeks and the observational phase up to 52 weeks. This is an investigator~     initiated study.~      Setting: Volunteer middle-aged daily smokers, who were recruited through newspaper~     announcements. The majority of the cohort subjects (n=513)were recruited for our previous~     follow-ip study during years 2003- 2009, and many of them continued daily smoking during the~     whole follow-up period.~      Participants: In all, 450 adult heavy smokers, who want to quit smoking and are willing to~     participate up to 52 weeks´ follow-up.~      Intervention and procedures: Standardized self-reported questionnaires with detailed smoking~     history with assessment of motivation to quit smoking, parameters of nicotine dependence,~     symptoms will be included. Smoking status will be repeatedly reassessed during the study~     visits, and self-reported smoking abstinence is verified with exhaled-carbon monoxide (CO)~     assessment. All adverse side effects either of drugs or of e-cigarettes, and symptoms related~     to the drugs or to withdrawal from smoking will be carefully reported.~   "
25325|NCT03235492|"~     (1) to determine whether the ratio of glycated albumin and total albumin in saliva is~     equivalent to blood and (2) to investigate whether the non-invasive SmartAlbu portable~     salivary sensor is as accurate as standard tests that measure glycosylated hemoglobin~     (HbA1c).~   "
25326|NCT03235479|"~     The purpose of this study is to compare the efficacy of BHV-3000 (rimegepant) versus placebo~     in subjects with Acute Migraines~   "
25327|NCT03235466|"~     This study seeks to explore whether heart rate variability (HRV) biofeedback can be effective~     in the treatment of chronic cough. Chronic cough has many causes, including asthma, postnasal~     drip, and gastroesophageal reflux disease (GERD), each with a specific treatment. However,~     among a subset of cough patients, no clear cause is found despite extensive workup, and~     traditional treatment methods do not provide relief. Several studies revealed less common~     causes of chronic cough and disordered breathing such as vagal neuropathy, paradoxical vocal~     fold motion, and stress. Additional research identified links between the neurological~     networks that produce the cough reflex and those that maintain normal breathing. HRV~     biofeedback is a self-regulation technique that uses computer equipment to monitor heart rate~     and breathing, two key functions of the autonomic nervous system. By using this non-invasive~     behavioral technique, cough patients can regulate their breathing and autonomic function,~     potentially leading to improved autonomic balance and a reduction in cough symptoms.~   "
25328|NCT03235453|"~     The randomized clinical trial will aim to analyze the influence of binary and quaternary~     rhythm through a protocol on motor symptoms, sleep, fatigue and quality of life in~     individuals with Parkinson's disease. The study design with a randomized clinical trial,~     including individuals diagnosed with Parkinson's Disease, will be divided into two groups: 1)~     Control group 2) Experimental group. Cognition, balance, gait freezing, functional mobility,~     quality of life, sleep, daytime sleepiness and fatigue will be evaluated. Through the~     application of binary and quaternary rhythm protocol for a period of 12 weeks. First, the~     descriptive statistics (mean, standard deviation and percentage) will be used to know the~     data, then the normality calculation using the Kolmogorov Smirnov test will be used to choose~     the statistical tests. All information will be collected before and after the intervention~     period. For statistical analysis, use the SPSS statistical package, version 20.0.~     (Kolmogorov-Smirnov or Shapiro-Wilk test) for the selection of statistical tests.~   "
25329|NCT03235440|"~     This study will evaluate the effects of a one week weight management summer camp on~     children's weight, quality of life, mood and feelings, self-esteem, weight management~     efficacy, enjoyment of physical activity, and body image.~   "
25330|NCT03235427|"~     CAROLE seeks to evaluate the relationship between chest Radiation Therapy and coronary artery~     disease.~      The purpose of CAROLE is to check the heart health of women who received breast cancer~     treatments in the past and protect them from future heart disease.~   "
25331|NCT03235414|"~     Healthy children will be recruited to under Magnetic Resonance Imaging (MRI)along with MR~     elastography to determine normal liver stiffness values.~   "
25332|NCT03235401|"~     To develop a patient-reported questionnaire to investigate the impact of PAH (pulmonary~     arterial hypertension) on patients' daily lives in terms of bothersomeness and disability.~   "
25333|NCT03235388|"~     Audit filters for monitoring trauma care quality are regarded as one of the most essential~     components of trauma quality improvement programmes; however, there is a paucity of evidence~     that shows that audit filters are associated with improved outcomes. Therefore, our aim is to~     assess if institutional implementation of audit filters reduce mortality in adult trauma~     patients.~   "
25334|NCT03235375|"~     A phase 1 open-label, single-dose study to evaluate the pharmacokinetics (PK), safety,~     tolerability and immunogenicity of MEDI0382 in subjects with renal impairment.~   "
25335|NCT03235362|"~     This is a phase 1, open label, multiple-dose, crossover clinical trial to investigate the~     pharmacokinetic drug interaction between YHR1705 and YHR1706 in healty male volunteers~   "
25337|NCT03235336|"~     The China Health and Nutrition Survey (CHNS), an ongoing open cohort, international~     collaborative project between the Carolina Population Center at the University of North~     Carolina at Chapel Hill and the National Institute for Nutrition and Health (NINH, former~     National Institute of Nutrition and Food Safety) at the Chinese Center for Disease Control~     and Prevention (CCDC), was designed to examine the effects of the health, nutrition, and~     family planning policies and programs implemented by national and local governments and to~     see how the social and economic transformation of Chinese society is affecting the health and~     nutritional status of its population. The impact on nutrition and health behaviors and~     outcomes is gauged by changes in community organizations and programs as well as by changes~     in sets of household and individual economic, demographic, and social factors.~      The survey was conducted by an international team of researchers whose backgrounds include~     nutrition, public health, economics, sociology, Chinese studies, and demography. The survey~     took place over a 7-day period using a multistage, random cluster process to draw a sample of~     about 7,200 households with over 30,000 individuals in 15 provinces and municipal cities that~     vary substantially in geography, economic development, public resources, and health~     indicators. In addition, detailed community data were collected in surveys of food markets,~     health facilities, family planning officials, and other social services and community~     leaders.~   "
25338|NCT03235323|"~     The aim of this study is to evaluate the effect of External CounterPulsation on postoperative~     heart function and vein graft failure rates of coronary artery bypass grafting patients.~   "
25339|NCT03235310|"~     The purpose of this study is to describe over time the rate of mother to child transmission~     of HIV and its prevention (PMTCT), to identify risk factors for transmission and to evaluate~     the safety of PMTCT strategies on outcome of pregnancy and in children not infected with HIV~   "
25340|NCT03235297|"~     The purpose of this study is to further understand the effects of altitude on the physiology~     of gas exchange in the pulmonary microcirculation in normal subjects and in people with~     chronic obstructive pulmonary disease (COPD) measured as the single-breath diffusing capacity~     for carbon monoxide (DLCOsb). The study will determine a mathematical formula to allow for~     altitude corrections in both study populations to be used clinically in pulmonary labs.~   "
25341|NCT03235284|"~     Patients with Parkinson's disease present motor dysfunctions such as stiffness, tremor,~     postural instability and bradykinesia, which leads to alterations of balance, necessitating~     specialized physiotherapeutic treatment. In this way this study aims to determine the~     effectiveness of two tools used in physiotherapy, kinesiotherapy and the Nintendo Wii. 36~     patients will be evaluated through the Berg Balance Scale, Dynamic Gait Index and Timed up~     and go, and will then be randomized to receive 16 sessions of Kinesiotherapy or Nintendo Wii~     alone or together. After this period the patients will be reassessed to verify the effects of~     the techniques.~   "
25342|NCT03235271|"~     The aim of this pilot study is to collect data on stroke patients using the BrainPulse Stroke~     Monitor. Patient characteristics, diagnostic procedures and clinical outcomes will be~     documented as part of the data collected to assess the clinical utility of the BrainPulse~     device. All eligible patients will be enrolled and assigned to a study Group based on~     confirmation of their diagnosis: Acute Ischemic Stroke, Hemorrhagic Stroke, Transient~     Ischemic Attack or No Stroke. The data collected from the BrainPulse will be compared across~     the four different study groups in an attempt to distinguish stroke from other non-stroke~     conditions that present with similar symptoms. Further assessments will also be made to~     evaluate if the BrainPulse can distinguish between hemorrhagic and ischemic stroke.~   "
25343|NCT03235258|"~     The purpose of this study is to describe the conditions of access to early treatment of~     children infected with HIV, their management on the long-term, and impact on growth, clinical~     and immunovirological prognosis, adherence to treatment, living conditions~   "
25344|NCT03235245|"~     This is a multicenter, 2-arm open-label, randomized comparative phase II study. The objective~     of this trial is to prospectively evaluate whether a sequential approach with an induction~     period of 12 weeks with encorafenib + binimetinib followed by combination immunotherapy with~     nivolumab + ipilimumab improves progression free survival compared to combination~     immunotherapy nivolumab + ipilimumab alone in patients with BRAF V600 mutation-positive~     unresectable or metastatic melanoma.~   "
25345|NCT03235232|"~     The purpose of this study is to evaluate the clinical efficacy of the BREMEN eye drops in the~     treatment of primary open-angle glaucoma or intraocular hypertension.~   "
25346|NCT03235219|"~     The purpose of this Phase 1b study is to assess the safety and tolerability of JNJ-64565111~     in adult men and women (of non-child bearing potential) with Type 2 Diabetes Mellitus.~   "
25347|NCT03235206|"~     This study is intend to show the positive impact that massage therapy can have on the lives~     of police officers. The study will demonstrate how regular treatment can change sleeping~     quality, stress levels and mental health. It will also investigate the impact that police~     work can have on the body.~   "
25348|NCT03235193|"~     In this prospective study, the ability of a machine learning algorithm to predict sepsis and~     influence clinical outcomes, will be investigated at Cabell Huntington Hospital (CHH).~   "
25349|NCT03235180|"~     The purpose of this study is to assess the effectiveness of a new ultrasound technology for~     evaluating Crohn's disease.~   "
25350|NCT03235167|"~     to observe the outcome of hepatocellular carcinoma patients under the combination treatment~     of transcatheter arterial chemoembolization (TACE) and CpG DNA~   "
25351|NCT03235154|"~     The main purpose of this pilot study is to investigate the safety, effectiveness and~     tolerability of the study medication in the treatment of people with chronic hepatitis C~     virus infection who regularly attend a psychiatrist-staffed clinic for opiate addiction~     treatment.~   "
25352|NCT03235141|"~     To compare the pharmacokinetic behavior of azithromycin eye drops in the tear with the~     original azithromycin eye drops, and evaluate the release behavior of both in the eye.~   "
25353|NCT03235128|"~     Childhood nephrotic syndrome is the most frequent glomerular disease that presents during~     childhood,primarily owing to a disturbed immune function.This disease is characterized by~     alterations in selectivity at the glomerular capillary wall that lead to an inability to~     restrict the urinary loss of protein.~   "
25354|NCT03235115|"~     This study aims to compare the short-term clinical performance of the three contact lenses~     (Methafilcon A IV, Ocufilcon B 1-day and Omafilcon A 1-day daily disposable).~   "
25355|NCT03235102|"~     This study aims to assess barriers that prevent obesity patients from receiving adequate care~     for their condition. The non-interventional study will be administered in the form of a~     30-minute, cross-sectional, online survey to various respondents. There is no experimentation~     involved in the process of data collection, and each survey poses minimal human risk.~      The study will evaluate lifestyle habits and weight management strategies perceived and/or~     practiced by each of 3 stakeholders in obesity: Patients (People with obesity), Providers,~     and Employers. A customized survey will be administered to each of the 3 stakeholders, and~     data will be analyzed based on respondents' answers.~   "
25356|NCT03235076|"~     To investigate the pharmacokinetics of BAY1101042 in subjects with mild to severe renal~     impairment, stratified according to estimated glomerular filtration rate (eGFR) determined~     2-10 days prior to dosing, and age-, weight- and gender- matched healthy subjects and to~     assess the safety, tolerability, and pharmacodynamics of BAY1101042 after a single oral dose~     of a 10 mg BAY1101042 given as 5 mg modified release (MR) tablet.~   "
25357|NCT03235063|"~     Increasing cases of women with dilated cardiomyopathy with a project of pregnancy are~     observed. However there is few knowledge and publications about cardiac diseases in pregnant~     women. Moreover the majority of medical articles deal with women with congenital heart~     diseases, valvular pathologies or peripartum cardiomyopathies, and few data are available in~     literature about women with dilated cardiomyopathy diagnosed before or during the first~     months of the pregnancy.~      Cardiologist and obstetrician advices are considerably limited when patients with dilated~     cardiomyopathy have a pregnancy project. Knowledges and know-how are currently based on~     limited personal experiment or on few clinical cases descriptions.~      Pregnancy represents a high-risk situation for patients with dilated cardiomyopathy. Creation~     of a cohort of pregnant women with dilated cardiomyopathy collecting specific data will allow~     to have a better overview and to appreciate possibilities of a pregnancy project, evolution~     risks and modalities for medical attention and to improve follow-up and advices delivered to~     these patients.~   "
25358|NCT03235050|"~     This study is designed to evaluate the dose range for MEDI0382 with respect to blood glucose~     control and weight loss effects, as well as to further explore the safety profile of MEDI0382~   "
25359|NCT03235037|"~     The purpose of this study is to evaluate the safety and effectiveness (how well a drug works)~     of Carbidopa/levodopa (Sinemet) in individuals with Angelman syndrome. Sinemet is a~     medication that helps to raise dopamine levels (a chemical that signals nerve cells) in the~     brain and central nervous system. There is evidence that dopamine concentrations may be~     abnormal in patients with Angelman syndrome. This study is investigating whether Sinemet~     helps motor control, intellectual function and the achievement of developmental milestones in~     people with Angelman syndrome~   "
25360|NCT03235024|"~     This is a Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized Phase II~     trial, comparing the effect of twice daily B244 application for 28 days vs vehicle~     application on treatment of mild to moderate AD~   "
25361|NCT03235011|"~     Evaluation of knowledge about contraception in sickle cell adolescents.~   "
25362|NCT03234998|"~     The objective of this study is to investigate the effects of two different dual-task balance~     interventions for stroke patients and older adults.~   "
25363|NCT03234985|"~     Treatment of acute myeloid leukemia (AML) consists in two main phases: induction and~     consolidation. Standard chemotherapy combination for induction treatment associates~     cytarabine (AraC), a nucleoside analog, and an anthracycline (most often daunorubucin). About~     60-70% of patients achieved complete remission after this standard chemotherapy. As~     cytarabine competes with endogenous nucleotides to exert its activity, the aim of this~     protocol is to study in vivo the effect of intracellular nucleotide pools on the efficacy of~     the induction treatment. Thus, intracellular nucleotides levels will be determined in~     peripheral blood mononuclear cells of patients with acute myeloid leukemia before treatment,~     and results will be compared with the efficacy of the treatment. This parameter will be~     assessed by the achievement of complete remission.~   "
25364|NCT03234972|"~     The primary purpose of this study is to compare the efficacy of daratumumab when combined~     with Velcade (bortezomib) and dexamethasone (DVd) to that of Velcade and dexamethasone (Vd),~     in terms of progression free survival (PFS) in Chinese participants with relapsed or~     refractory multiple myeloma (MM).~   "
25365|NCT03234959|"~     Cerebral Palsy (CP), due to pre-perinatal brain lesions, is a main cause of childhood~     disabilities with high cost for individuals and society. Early Intervention (EI), if~     intensive enough but affordable by patients, family and health services can improve its~     outcome. A recent Cochrane review indicates the positive effects of Infant Massage (IM) in~     gross and fine motor skills, visual development and parent infants interaction in preterm~     infants. Recently, a new technological tool, called CareToy has been developed as a~     tele-rehabilitation tool for delivering at home EI. The effects of CT training on~     neurodevelopmental outcome have been recently tested in a sample of low-risk preterm infants~     with very promising results. The aim of the project is to provide evidence, by a RCT, of the~     efficacy of CareToy (CT) training versus Infant Massage, in a sample of 45 infants aged 3-12~     months (or with motor competencies from initial head control to unstable sitting position) at~     high risk for CP according to strict clinical and neuroradiological signs. Enrolled infants~     will be randomized in 2 groups: CareToy and Infant Massage. Infants allocated in CT group~     will perform a training with CT while the others will perform infant massage. Both trainings~     will be carried out at home by parents with the monitoring of the therapists. Both~     interventions will last 8 weeks. All enrolled infants will be evaluated at baseline (T0),9~     wks after the CT/IM (T1), 9 wks after T1 (T2) and at 18 months of post term age (T3). Infant~     Motor Profile will be the primary outcome measure.~   "
25366|NCT03234946|"~     Diabetes is a chronic disease that requires long-term lifestyle changes that may affect the~     whole family. Hence, during the last decade, studies have focused mainly in the role of the~     members of the family and their influence in life quality or clinical outcomes of patients~     with diabetes. Therefore, the delivery of education only to the patients with type 2 diabetes~     mellitus may restrict the expectations of success in achieving the necessary modifications in~     lifestyle.~      Objectives: To assess the effect of the CAIPaDi (Centre of Comprehensive Care for the~     Patients with Diabetes) program interventions on various health indicators relatives of~     patients with type 2 diabetes mellitus.~   "
25370|NCT03234881|"~     Inclusion Criteria: aged 21 and older, BMI>=25, and presence of recurrent binge eating on the~     MOVE! Survey. Exclusion Criteria: more than 4 MOVE! sessions in the prior year; active~     psychosis or suicidal ideation; medical or psychiatric illness, or cognitive deficits that~     interfere with providing consent or completing assessments, and; pregnancy or lactation.~      Participants will be recruited from the VA's MOVE! Program at VA Connecticut Healthcare~     System (both Newington and West Haven campuses). Those participants who meet eligibility and~     are interested in the study will meet with a research associate who will obtain written~     consent. A baseline appointment will be made where the participant will complete written~     assessments, anthropometric measures (weight, height, blood pressure etc.), along with a~     blood draw. Participants will then be randomized, by luck of a draw, to either MOVE! or~     MOVE!+gshCBT treatment.~      For those randomized to the MOVE! condition, participants will continue in the MOVE! program~     by meeting with the multidisciplinary team in a group setting once a week for 60 minutes, for~     16 weeks. The group sessions are lead by a dietician, health psychologist, and physical~     therapist.~      For those randomized to the MOVE!+gshCBT treatments, participants will continue in the MOVE!~     program as described above, but will also partake in 8 individualized sessions over a 3-month~     period. Participants will be given a treatment manual to read at home, ask to complete daily~     food logs and work with the study therapist to create goals and complete homework that is~     geared at examining and changing how participant think about binge eating and how that~     thinking affects behavior. Lastly, a walking program will also be incorporated into the~     treatment.~      For both treatment arms, 3 months from treatment starting, then again at 9 months and 15~     months, participants will be asked to complete post and follow up assessments, much like the~     baseline.~   "
25371|NCT03234868|"~     The aim of this research project is emphasize the benefit of the digital workflow compared to~     conventional impressions and crown processing with standard la procedures. The objectives of~     the present study are to measure and compare the global cost, the time spent in the dental~     chair and in the lab and the fit of both digital and conventional workflow. Additionally,~     patient centered outcomes will be recorded.~   "
25372|NCT03234855|"~     This study is gathering opinions from surgeons on the usability of our laparoscopic measuring~     device.~   "
25373|NCT03234842|"~     This study will evaluate if proton beam therapy as part of chemoradiation results in a~     decrease in diffusion lung capacity of carbon monoxide (DLCO) compared to photon radiation~     therapy for esophageal carcinoma. A secondary objective is to determine effects on cardiac~     function, quality of life, and compare acute and late toxicities.~   "
25374|NCT03234829|"~     Determination of The Combined Mesio-Distal Widths of The Permanent Mandibular Incisors and~     That of The Maxillary and Mandibular Canines and Premolars in a Group of Egyptian Children in~     Rural Areas of Sohag Governorate: A Cross Sectional Study~   "
25375|NCT03234816|"~     Norepinephrine has been recently introduced as a prophylactic vasopressor during Cesarean~     delivery with promising results ; However, the optimum dose for efficient prophylaxis with~     the least side effects is not known. In this study, we will compare three doses (0.05, 0.1,~     0.15 mcg/Kg/min) of norepinephrine for prophylaxis against Post-Spinal hypotension during~     cesarean delivery.~   "
25376|NCT03234803|"~     Polymethyl methacrylate have been used since 1937 as a gold standard for a denture base~     material because of its several advantages as; good esthetics, adequate strength, easy repair~     and simple processing techniques. As any material it has some problems as polymerization~     shrinkage, low impact and flexural properties and low fatigue resistance2. So polyamide was~     introduced into dentistry to be used as a denture base material in order to solve these~     problems. Polyamide denture base materials have some superior properties than PMMA as; High~     impact & flexural strength, excellent esthetics and less release of residual monomers4.~     Although being an advantage from the point of patient satisfaction, flexural property~     considered to be a contraindication for a denture base material.~      The invistigators' trial is done in order to improve rigidity of a polyamide material as well~     as to improve oral health related quality of life in comparison to heat cured polymethyl~     methacrylate.~   "
25377|NCT03234790|"~     Strong scientific understanding of how emissions from diesel engines impact the lungs could~     improve policies and regulations protecting workers exposed to diesel exhaust. Accordingly,~     we are recruiting healthy volunteers who are non-smokers to participate in our study.~     Volunteers sit in a room for four hours and breathe either clean filtered air or air that~     contains pollution at various concentrations similar to occupational settings such as bus and~     ferry terminals where diesel engines are used. A respirologist assesses the volunteer's lung~     health and clinical samples are taken. We are equipped with advanced molecular biology tools~     to measure different molecules and compare samples from our volunteer subjects following~     exposure to clean air or diesel exhaust. Our research aim is to find a simple, clinically~     relevant strategy that can be used to measure the impact of diesel exhaust on workers' lung~     health. This knowledge will empower regulators, companies, and ultimately workers to better~     manage their health risks. Our research aims to provide specific data to help regulators to~     make informed decisions about the risks of diesel exhaust exposure.~   "
25378|NCT03234777|"~     Diarrhea and vomiting in children is a common reason to visit the emergency department. There~     has been a lot of research on how best to treat children with diarrhea and vomiting who visit~     the emergency department; however, the care children receive varies by healthcare provider~     and across hospitals. Additionally, there are things parents can do at home to help manage~     childhood diarrhea and vomiting and potentially avoid a trip to the emergency department.~     This shows an urgent need for knowledge translation, that is, efforts to align research~     knowledge and healthcare practice. Actively involving parents in healthcare decisions has the~     potential to bridge this gap; however, there is little research on the best ways to~     communicate complex health information to parents of sick kids. In 2013, a national needs~     assessment was conducted with parents seeking care for their kids in general emergency~     departments (trekk.ca). This survey showed that 39% of parents looked for information about~     their child's health prior to coming to the emergency department and that 44% of these~     parents looked for this information on the internet. This means that the development and~     evaluation of digital tools to give parents timely and effective child health information has~     the potential to reduce unnecessary emergency department visits, empower parents in health~     decision-making, and ultimately improve child health outcomes. In this project, parents will~     be actively involved in the evaluation of a digital tool, a whiteboard animation video,~     designed to communicate the best research evidence on the treatment and management of~     vomiting and diarrhea in children. In this pilot trial, parents in two emergency departments~     will be randomized to view the video or a sham video, and then provide quantitative and~     qualitative data on the potential effectiveness of the video, the perceived benefit and value~     of the knowledge translation intervention for pediatric vomiting and diarrhea, the~     feasibility of using iPads and an electronic data collection platform to conduct research~     with this population, the time required to complete data collection, and parents' willingness~     to participate in future, similar research.~   "
25379|NCT03234764|"~     The purpose of this study is to evaluate the clinical usefulness of assessing specific human~     allergy antibodies and other immunologic parameters associated with the diagnosis, evolution,~     and management of allergic disease.~   "
25380|NCT03234751|"~     The purpose of the study is to compare the effects of nesiritide to placebo administered by a~     continuous IV infusion over 48 hours for the treatment of insulin resistance in healthy,~     obese, insulin resistant individuals.~   "
25381|NCT03234738|"~     This is a single-center, randomized, placebo-controlled, double-blind,~     multiple-ascending-dose, inpatient study to assess the safety, tolerability, and~     pharmacokinetics of TP‑271 in healthy subjects. Subjects aged 18 to 50 years who fulfill the~     inclusion/exclusion criteria will be enrolled in this study.~   "
25382|NCT03234725|"~     The aim of the present study is to develop and evaluate a computer-based methods for~     automated and improved detection and classification of different colorectal lesions,~     especially polyps. For this purpose first, pit pattern and vascularization features of up to~     1000 polyps with a size of 10 mm or smaller will be detected and stored in our web based~     picture database made by a zoom BLI colonoscopy. These polyps are going to be imaged and~     subsequently removed for histological analysis. The polyp images are analyzed by a newly~     developed deep learning computer algorithm. The results of the deep learning automatic~     classification (sensitivity, specificity, negative predictive value, positive predictive~     value and accuracy) are compared to those of human observers, who were blinded to the~     histological gold standard.~      In a second approach we are planning to use LCI of the colon, rather than the usual white~     light. Here, we will determine, whether this technique could improve the detection of flat~     neoplastic lesions, laterally spreading tumors, small pedunculated adenomas and serrated~     polyps. The polyps are called serrated because of their appearance under the microscope after~     they have been removed. They tend to be located up high in the colon, far away from the~     rectum. They have been definitely shown to be a type of precancerous polyp and it is possible~     that using LCI will make it easier to see them, as they can be quite difficult to see with~     standard white light.~   "
25383|NCT03234712|"~     This is an open-label, Phase 1, dose-escalation study to determine the maximum tolerated dose~     (MTD) and the recommended phase two dose (RPTD), and to assess the safety, preliminary~     efficacy, and pharmacokinetic (PK) profile of ABBV-321 for participants with advanced solid~     tumors likely to overexpress the epidermal growth factor receptor (EGFR) or its ligands. The~     study will consist of 2 phases: Dose Escalation Phase and Expanded Safety Phase.~   "
25384|NCT03234699|"~     This study is aimed to investigate the influence of cenobamate on the activity of CYP3A4/5,~     CYP2B6, CYP2C19, and CYP2C9 by using drugs recommended by both the FDA and EMA as in vivo~     probes. In order to avoid a potential pharmacokinetic interaction between the probes,~     midazolam (CYP3A), warfarin (CYP2C9), and omeprazole (CYP2C19) will be administered together~     as a validated cocktail and separately from bupropion (CYP2B6) using an adequate washout time~     period between the 2 assessments.~      The starting daily dose of cenobamate will be 12.5 mg, which will be administered for 2~     weeks. Then, daily cenobamate doses will be increased every 2 weeks to 25 mg, 50 mg, 100 mg,~     150 mg, and 200 mg. The CYP probes will be tested before cenobamate administration, at steady~     state at 100mg/day of cenobamate for midazolam only and finally at steady state at 200mg/day~     of cenobamate for all CYP probes.~      The results of this DDI study will provide a basis to make appropriate dose recommendation~     for a safe use of concomitant drugs with cenobamate using these isoenzymes in their metabolic~     pathway.~   "
25385|NCT03234686|"~     This study is a phase 2, randomised, placebo-controlled, multicentre study to investigate the~     safety and efficacy of Deferiprone in participants with Prodromal Alzheimer's Disease (pAD)~     and Mild Alzheimer's Disease (mAD). In this phase 2 study, the investigators aim to determine~     whether Deferiprone (15 mg/kg BID orally) slows cognitive decline in Alzheimer's patients. As~     secondary outcomes, safety and iron levels in the brain will be evaluated.~   "
25386|NCT03234673|"~     Vitiligo is an acquired disorder of the skin and mucous membranes characterized by well~     circumscribed depigmented macules and patches that occur secondary to selective destruction~     of melanocytes (Zhang et al., 2009).~      Generalized vitiligo is the most common clinical presentation and often involves the face and~     acral regions (Alikhan et al., 2011).~   "
25387|NCT03234660|"~     Neuroapoptosis is induced by the administration of anesthetic agents to the young brain.~     Recent studies showed that the a2-adrenoceptor agonist, dexmedetomidine plays a trophic role~     during development and is neuroprotective in several settings of neuronal injury in animals.~     We hypothesized that neuroprotective effect of dexmedetomidine would be associated with~     evidence of brain injury detected by elevation of plasma concentration of glial fibrillary~     acid protein in children undergoing general anesthesia.~   "
25388|NCT03234647|"~     Safety and performance evaluation of the Doraya catheter in patients admitted with AHF.~   "
25389|NCT03234634|"~     This study is a prospective, partly randomized, multi-center, Phase III, controlled trial,~     designed to show that the onset-to-puncture time (OPT) for good functional outcome (defined~     by modified Rankin Scale score at 3 months, 0-2) can be set depending on collateral status~     based on multiphase CT angiogram. The purpose of this study is to prove that (1) for patients~     with poor collaterals, there will no difference in good outcome rate between endovascular~     treatment and best medical treatment group if onset-to-puncture time is between 150 minutes~     and 600 minutes, and 2) for patients wih good collaterals, the rate of good outcome is equal~     to or greater than 42% (10% greater than historical control) if onset-to-puncture time is~     between 150 minutes and 600 minutes. Patients will initially be classified into 3 arms based~     on both collateral status on multiphase CT angiography and whether or not receiving~     endovascular thrombectomy: group 1, patients with good collaterals and receiving endovascular~     thrombectomy, 2) group 2a, patient with poor collaterals and receiving endovascular~     thrombectomy, and 3) group 2b, patients with poor collaterals and not receiving endovascular~     thrombectomy. Patients with good collaterals will receive endovascular thrombectomy (EVT) if~     onset-to-puncture time is between 150 minutes and 600 minutes after last seen well time. Of~     the patients with poor collaterals, they will be randomized into endovascular treatment and~     best medical treatment group, if onset-to-puncture time is between 150 minutes and 600~     minutes, (onset-to-puncture time is not possible within 150 minutes but possible within 600~     minutes after last seen well). Primary endpoint is the rate of good outcome at 3 months. The~     number of subjects needed with statistical power of 0.8 and alpha value of 0.025 is estimated~     309 patients.~   "
25390|NCT03234621|"~     The purpose of this study is to find a proper ventilation strategy for one-lung ventilation~     to prevent postoperative pulmonary complications~   "
25465|NCT03233620|"~     The aim of our study was to assess the effectiveness of contemporary knee arthroplasty in~     working-age patients (< 65 years) by conducting a prospective cohort study with 2-year follow~     up. Outcomes were measured comprehensively using various patient-reported outcome measures~     (PROMs) to provide information on the effect of knee arthroplasty on pain, satisfaction,~     physical activity, activities of daily living, and quality of life.~   "
46439|NCT02959021|"~     The purpose of this study is to examine whether a primary care weight management intervention~     delivered by peer coaches produces greater weight loss than a self-directed program without~     peer coach support.~   "
25391|NCT03234608|"~     The health system is ill-equipped to meet the needs of autistic adults. The Academic Autism~     Spectrum Partnership in Research and Education (AASPIRE), an academic-community partnership~     comprised of academics, autistic adults, healthcare providers, and supporters, has used a~     community based participatory research (CBPR) approach to develop and test an online~     healthcare toolkit aimed at improving primary care services for autistic adults. It was~     specifically designed as a low-intensity, sustainable intervention that can realistically be~     used in busy primary care practices that do not have a special focus on autism or other~     developmental disabilities. The toolkit includes the Autism Healthcare Accommodations Tool~     (AHAT)--an automated tool which allows patients and/or their supporters to create a~     personalized accommodations report for their primary care provider (PCP)--and other targeted~     resources, worksheets, checklists, and information. The investigators' pilot work has~     demonstrated that the AHAT has strong construct validity and test-retest stability, the~     toolkit is highly acceptable and accessible, and it has the potential to decrease barriers to~     care and increase patient-provider communication. The investigators' long-term plan is to~     conduct a hybrid effectiveness-implementation trial, using a cluster randomized trial design,~     both to test the effectiveness of the AASPIRE Healthcare Toolkit in improving healthcare~     quality and utilization and to assess the utility of implementation strategies in diverse~     healthcare systems. The objective of this proposal is to use a CBPR approach to understand~     how to integrate the toolkit into these health systems, collect more robust efficacy data,~     and explore potential mechanisms of action. The investigators will do so by conducting a~     6-month pilot study with patients assigned to intervention and control clinics in three~     diverse health systems. The investigators will meet our objectives by achieving the following~     specific aims: 1) to determine how to integrate use of the toolkit within diverse health~     systems; 2) to test the effect of the toolkit on short-term healthcare outcomes; 3) to use a~     mixed-methods approach to further explore the toolkit's mechanisms of action; and 4) to~     refine the recruitment, retention, data collection, and system integration strategies in~     preparation for the larger cluster-randomized trial.~   "
25392|NCT03234595|"~     A Phase I/IIa Study to Determine the Maximum Tolerated Dose (MTD) and to Evaluate the Safety~     and Efficacy Profile of Cerebraca Wafer Plus Adjuvant Temozolomide (TMZ) in Patients With~     Recurrent High Grade Glioma.~      High grade gliomas, glioblastoma multiforme (grade IV) and anaplastic anaplastic astrocytoma~     (Grade III), are the most comment malignant brain tumor. The cause of gliomas remains~     unknown. Despite of several researches on environmental hazards and genetic alterations, no~     direct causes were found.~      Patient suffering from glioma usually develops symptoms such as headaches, seizures, memory~     loss and changes in behavior in its early phase. At later stages, patients may encounter loss~     of movement and sensation, language dysfunction and cognitive impairments depending on~     location and size of the tumor. The average survival of glioblastoma patients is 15 months~     regardless of the use of multimodal therapy.~      (Z)-BP/polymer wafer, designated as Cerebraca wafer, is a biodegradable wafer for~     interstitial implantation comprises (Z)-n-butylidenephthalide ((Z)-BP; the active moiety) and~     Carboxyphenoxypropane-Sebacic Acid Copolymer (CPPSA; the excipient).~      Cerebraca wafer, the first human-use drug product, is a biodegradable implant comprises~     (Z)-n-butylidenephthalide ((Z)-BP) and CPPSA. According to pre-clinical study, (Z)-BP could~     reduce glioma migration and invasion, it also could reduce the tumor stem cell marker gens.~   "
25393|NCT03234582|"~     The primary objective of the study will be to compare intraoperative post TOF repair RVOT~     gradient under two different anaesthetic depths. Secondary objectives will be to follow up~     change in RVOT gradient till 1 month post-operatively, observe extubation time, inotropes~     used post-operatively by vasoactive- inotropic score (VIS), RV functions at discharge from~     ICU and at 1 month follow- up~   "
25394|NCT03234569|"~     This pilot study is a collaborative effort between Northwell Health's Departments of~     Fertility and Radiology.The aim of this study is to evaluate the feasibility of the~     Sonohysterosalpingography (sonoHSG) for it to be determined as the standard of care.~     Additionally, it aims to improve the work up of infertility by integrating the examination of~     structural abnormalities of the Fallopian tubes and uterus into a single radiation free~     ultrasound guided procedure, the sonoHSG.~   "
25395|NCT03234556|"~     This randomized phase II trial studies how well systematic random biopsy or magnetic~     resonance imaging (MRI)-ultrasound image (US) fusion biopsy work in diagnosing prostate~     cancer in patients with elevated prostate specific antigen. Systematic random biopsy and~     MRI-US fusion biopsy may work better in improving the accuracy of prostate cancer detection.~   "
25396|NCT03234543|"~     This phase II randomized (1:1) controlled trial will examine the effects of remote ischemic~     conditioning (RIC) on the outcomes of major abdominal surgery. One hundred subjects will be~     enrolled at a single institution - University Hospital - Newark. The study population are~     patients undergoing major abdominal surgery (anticipated to be >/= 2 hrs long with a hospital~     stay >/= 2 days). Subjects in the treatment group will receive lower limb ischemic~     conditioning at 3 different time points: before surgery, POD 1 and POD 2. The primary outcome~     is the 30-day comprehensive complications index (CCI). Key secondary outcomes are changes in~     systemic inflammatory markers in peripheral blood and 30-day mortality.~   "
25397|NCT03234530|"~     This study focuses on the prevalence and identification of kidney disease among participants~     of the WTC Health Program and the study team are planning to assess kidney disease in a~     multi-factorial manner. The first aim of this study is to correlate kidney dysfunction with~     9/11 exposure, and the study team predicts that exposure to 9/11 is an independent risk~     factor in kidney disease among the WTC Health Program participants. Secondly, the study team~     proposes that a well-established WTC-related condition, obstructive sleep apnea (OSA), is~     independently associated with kidney disease. In addition, the study team believe there is a~     temporal causative relationship between evidence of kidney disease and the severity of OSA.~     Finally, the last aim is to further identify and explore potential mechanisms and phenotypes~     of kidney disease in participants of the WTC Health Programs.~      Regardless of whether the analyses support or reject these hypotheses, the findings will be~     of equally great public health importance. Successful completion of the proposed research~     would address a critical knowledge gap regarding the risk of kidney damage among this group~     of patients, and would inform future mechanistic studies with the potential to impact~     prevention.~   "
25398|NCT03234517|"~     Vaginal Clindamycin Cream Plus Vaginal probiotic for treatment of Bacterial Vaginosis~   "
25399|NCT03234504|"~     This prospective study investigated the validity and test-retest reliability of stereopsis~     test using head-mount display (HMD). Contour-based circles (crossed disparity: 1,960 to 195~     arc of seconds(arc secs)) were generated as separate images on a high resolution phone~     display (Galaxy S7; Samsung, Suwon, Korea) using a HMD (Galaxy Gear VR; Samsung, Suwon,~     Korea). Two images were independently projected to each eye as graded circles with random dot~     background. While the position of the stimulus changed from among 3 possible locations, the~     subjects were instructed to select the circle with disparity by pressing the corresponding~     position on a keypad. The results of the new HMD stereotest were compared to those from~     standard Randot and TNO stereotests.~   "
25401|NCT03234478|"~     Every year, approximately 9,000 Parkinson disease (PD) patients undergo deep brain stimulator~     (DBS) placement into the subthalamic nucleus (STN-DBS). Studies suggest that PD patients with~     mutations in the glucocerebrosidase (GBA) gene are at high risk for cognitive impairment and~     approximately 10-17% of subjects undergoing DBS carry GBA mutations. There may be an~     interaction between STN-DBS, which also impairs cognitive function, and GBA, resulting in~     worsened cognitive function. This project will 1) determine the relationship between GBA~     mutation status and post-operative STN-DBS cognitive function, 2) broaden genotype-phenotype~     relationships of GBA mutation carriers and 3) provide scientific knowledge regarding the~     longitudinal cognitive effects of DBS in GBA mutation carriers through repeated~     neuropsychological testing.~   "
25402|NCT03234465|"~     The purpose of the study is to evaluate the efficacy, safety and tolerability of topically~     administered AG013 compared to placebo for reducing Oral Mucositis (OM) in patients~     undergoing chemoradiation for the treatment of head and neck cancer, as measured by the~     duration, time to development, and overall incidence of OM during the active treatment phase,~     beginning from the start of chemoradiation therapy (CRT) until 2 weeks following its~     completion.~      The effect of AG013 on patient-reported symptoms and analgesic use during the active~     treatment phase, and on the cumulative radiation dose administered before the onset of OM~     will also be evaluated, as will biomarkers and, in a subset of subjects, the PK~     (pharmacokinetic) profile of AG013.~   "
25403|NCT03234452|"~     A randomized, double-blind, placebo-controlled, cross-over trial performed at one centre in~     Italy to explore the ability of a multistrain probiotic mixture, to modulate markers of~     inflammation and intestinal barrier function and gastrointestinal symptoms in healthy~     volunteers with self-reported anxiety.~   "
25404|NCT03234439|"~     Chronic pain is becoming increasingly more prevalent worldwide. High rates of co-morbid~     psychological distress are also commonly found among individuals living with chronic pain.~     Often requiring a multi-modal treatment approach, a growing body of literature suggests that~     digital behavioral health interventions and tools may serve as promising complementary~     options to help individuals cope with the pain.~   "
25405|NCT03234426|"~     Following stroke, patients loses functions of the motor, sensory and higher brain cognitive~     faculties to various degrees which lead to diminished balance. It has been documented that~     hemiplegic or hemiparetic stroke patients presented with more posture sway, asymmetric weight~     distribution, impaired weight-shifting ability and decreased stability capability. There are~     many balance exercises and strategies; to improve balance in elderly age group population, to~     prevent fall prevention. But we have very few evidences of giving manual perturbation balance~     training in stroke patients to improve speed, balance and function. Therefore this study is~     taken up to examine whether the manual perturbation balance training is more effective in~     improving speed, balance and function in stroke patients.~   "
25406|NCT03234413|"~     Clinical guidelines recommend the use of Botulinum Toxin-A (BoNT-A) for localized/segmental~     spasticity in children with cerebral palsy. At the Kocaeli University (KOU) Department of~     Physical Medicine and Rehabilitation (PMR) more than 800 patients have been injected with the~     two approved toxinA types; OnabotulinumtoxinA or AbobotulinumtoxinA.~      With this study investigators would like to evaluate retrospectively if switching from one~     toxin to another is safe as well as to evaluate if the efficacy when switching from one toxin~     to another was maintained.~   "
25407|NCT03234400|"~     Participants will be randomized to one of three study vaginal rings (VRs) in a 1:1:1 ratio,~     25 mg, 100 mg or 200 mg VRs.~   "
25408|NCT03234387|"~     A great medical success is the increase in the median survival age associated with cystic~     fibrosis (CF). However, this success has led to a new era of research with the aim to~     maximise the quality of life (QoL) of the aging CF population. Recent research has~     demonstrated that the traditional method of determining disease progression, i.e. pulmonary~     function, no longer adequately predict survival rates. Therefore, various bodies have~     promoted cardiopulmonary exercise testing (CPET), as outcomes from this test (e.g. one's~     maximal O2 uptake [VO₂max]) are known predictors of the QoL, risk of hospitalisation and~     prognosis of individuals with CF.~      One of the most common non-pulmonary co-morbidities of CF is CF-related diabetes (CFRD).~     Importantly, CFRD is associated with a poorer pulmonary function compared to CF patients~     without CFRD, and ultimately a worsened prognosis. Despite this, the influence an impaired~     glycaemic control has upon the VO₂max derived from a CPET is unknown in CF. Therefore, the~     present study aims to assess whether VO₂max, an established determinant of QoL, differs~     between patients with CF with and without established CFRD as well as a group of age- and~     gender-matched healthy control subjects.~      The additional measures within the present study, such as: biomarkers of inflammation, redox~     balance and nitric oxide (NO2) bioavailability, as well as functional measures of~     microvascular endothelial function will aid our knowledge of the physiological abnormalities~     which are a cause or consequence of CFRD. Importantly, by identifying the factors which may~     contribute to CFRD progression and those that are viable for early intervention, mean the~     aims and objectives of this study are compatible with the top 10 research objectives set by~     the CF Trust.~   "
25409|NCT03234374|"~     This is a multicenter randomized, single-blind, controlled study. The primary objectives of~     this study are to obtain the pharmacokinetic profile and the relative bioavailability of the~     INL-001 matrix during and after open hernioplasty compared to Marcaine™ 0.25% infiltration.~   "
25410|NCT03234361|"~     An increasing number of studies have indicated that most fast food and common grocery items,~     contain large amount of inorganic phosphate-based food additives , which are highly~     absorbable. The long-term cardiovascular consequences of a high phosphate diet are unknown~     but the existing database implicates phosphate excess as an independent risk factor for~     cardiovascular events in individuals with and without chronic kidney diseases (CKD). High~     phosphate consumption clearly induces BP elevation in rats with normal kidneys. However, the~     mechanisms underlying phosphate-induced hypertension and the relevance of these rodent~     studies to human hypertension have not been determined. We seek to investigate the role of~     high phosphate diet in human hypertension and assess the effect of high phosphate diet on~     muscle sympathetic nerve activity and the exercise pressor reflex.~   "
28151|NCT03198507|"~     The test and treat strategy for treating dyspeptic patients who are H. pylori positive is~     rapidly becoming the standard of care. This study will test the effectiveness of RHB-105, a~     new triple therapy to treat H. pylori infection in dyspeptic patients against an active~     comparator.~   "
25411|NCT03234348|"~     This is a prospective, randomized, active control, single-blind, non-inferiority, multicenter~     clinical trial. 148 subjects will be registered at up to 10 Spanish sites. Subjects will be~     followed for 5 years.~      All eligible patients (STEMI < 12 hours from onset of chest pain) will be randomized to~        -  Biotronik MAGMARISTM Sirolimus Eluting Bioresorbable Vascular Scaffold System (M-BRS) or~        -  Biotronik ORSIRO Sirolimus Eluting Coronary Stent System~      Endothelium-independent vasomotor response (NTG injection) will be analyzed at 12 months~     angiographic follow-up (Primary endpoint).~      In a subgroup of 40 patients Optical Coherence Tomography will be performed after the~     procedure and at 12 months follow-up.~      Angiographic (QCA pre- and post-procedure and at 12 months follow-up), OCT data (at 12 months~     follow-up) will be analyzed off-line by an independent core lab.~   "
25412|NCT03234335|"~     Multiple myeloma (MM) is a malignant plasma cell disorder, characterized by the presence of~     more than 10 % of clonal plasma cells in the bone marrow. Therapeutic intervention is~     recommended when at least one of the myeloma defining events occurs (CRAB features). Renal~     impairment (RI) is one of the most common complications of MM, accounting for 20-30 % of MM~     patients at diagnosis and 40-50% of patients during the course of their disease. To date,~     there is no defined consensus for the management of myeloma patients with renal failure. It~     is then of clinical importance to better considering available therapeutic options to improve~     responses and survival of these patients.~   "
25413|NCT03234322|"~     Little evidence exists on the impact of diabetes risk scores, e.g. on physicians and~     patient's behavior, perceived risk of persons, shared-decision making and particularly on~     patient´s health. The aim of this study is to investigate the impact of a non-invasive~     diabetes risk prediction model in the primary health care setting as component of routine~     health checks on change in physical activity.~   "
25414|NCT03234309|"~     This phase II trial studies ferumoxytol in the magnetic resonance imaging of pediatric~     patients with brain tumors. Magnetic resonance imaging using ferumoxytol may help in viewing~     a brain tumor and blood vessels in and around the tumor in a different way than the standard~     gadolinium-based contrast agent. Imaging with this experimental contrast agent may give~     doctors more information about tumor blood supply and the extent of the tumor itself.~   "
25415|NCT03234296|"~     Appendicectomy has been the treatment of acute appendicitis for over a hundred years.~     Appendicectomy, however, includes operative and postoperative risks despite being a routine~     operation. At the same time other similar intra-abdominal infections, such as diverticulitis,~     are treated with antibiotics. Several studies have proved promising results of the safety and~     efficiency of antibiotics in the treatment of acute uncomplicated appendicitis. Our previous~     APPAC study, published in 2015 in the Journal of American Medical Association, also proved~     promising results with 73% of patients with CT-diagnosed uncomplicated appendicitis treated~     successfully with antibiotics within one-year follow-up. None of the patients initially~     treated with antibiotics that later had appendectomy had major complications. The results of~     the APPAC trial suggest that CT proven uncomplicated acute appendicitis is not a surgical~     emergency and antibiotic therapy is a safe first-line treatment option. Reducing unnecessary~     appendectomies has also been shown to lead to significant economic savings.~      Already in 1886 Fitz noted that 1/3 of patients in a large series of autopsies from the~     pre-appendicectomy era had evidence of prior appendices inflammation suggesting spontaneous~     resolution of acute appendicitis. Acute appendicitis is thought to be similar to acute~     diverticulitis (left-sided appendicitis) and this similarity has been shown in~     epidemiological studies. Recent studies have shown no benefit of antibiotic treatment in the~     treatment of uncomplicated diverticulitis with outpatient management without antibiotics~     proving safe and well-functioning.~      The aim of this randomised double-blinded study is to compare antibiotic therapy with placebo~     to evaluate the role of antibiotic therapy in the resolution of CT-diagnosed uncomplicated~     acute appendicitis.~      The hypothesis is that antibiotic therapy is necessary in the treatment of acute~     uncomplicated appendicitis and that antibiotic therapy is superior to spontaneous resolution~     (placebo) with the primary endpoint evaluated at ten days after the intervention.~   "
25416|NCT03234283|"~     A prospective, open label, non-randomized, single centre safety and feasibility study.~     Patients with no expected airway difficulties scheduled for elective surgery including~     tracheal intubation and general anesthesia procedures will be enrolled into the study.~     Following standard induction of anesthesia, the IRRIS will be attached to the patient's neck~     skin just beneath the laryngeal prominence (Adam's apple) and the intubation will be~     performed by using a video-laryngoscope in a standardized fashion. The IRRIS device emits a~     light that penetrates through the skin into the airway and that is visible on the~     video-laryngoscope display. This light highlights the right pathway for the tracheal tube and~     facilitates the visual recognition and identification of the laryngeal inlet. In case of~     problems identified during the induction period such as an unexpected difficult intubation~     situation and the IRRIS does not provide the expected facilitation of intubation, the local~     unexpected difficult airway protocol goes into effect.~   "
25417|NCT03234270|"~     The many complaints that have been expressed by the US aircrew of the F-35 regarding the heat~     stress in the cockpit raised an obvious concern that, as a result of such heat levels, the~     aviators' core body temperature may increase significantly, and subsequently cause severe~     cognitive impairment- risking both the pilot and the mission.~      In order to validate this hypothesis, we will measure the aviators' core body temperatures~     while inside the cockpit of the F-35, to see whether their core body temperatures are rising~     to a level that can cause heat stress or not. The temperatures will be measured on another~     fourth generation aircraft as well for comparing purposes.~      The temperatures will be measured using a Telemetric pill which will be ingested by each~     aviator. Once ingested, the pill will transmit the data to an external monitor. The collected~     data will be examined and analyzed in order to determine the likelihood of heat stress~     occurrence.~   "
25418|NCT03234257|"~     Unstable plaques are characterized by lower segmental stiffness and intimal~     neovascularization compared to stable plaques. Our objective is to determine the capacity of~     the elastographic parameters obtained by the UF to discriminate the unstable to the stable~     plaques. We hope to improve the stroke prediction in asymptomatic patients with carotid~     stenosis.~   "
25419|NCT03234244|"~     Randomized, Open-label, Single-dose, 3-period, 6-sequence, 3-way crossover Study~   "
25420|NCT03234231|"~     Intellectual disabled persons faced more dental problems. According to a medical review paper~     of international and local studies, this group has poorer dental hygiene, more severe gum~     disease and more untreated caries. In 2010, a report from the guardians in Hong Kong~     mentioned that most adults with intellectual disability cannot clean their teeth, the have~     dental problems and it is very difficult for intellectually disabled students to co-operate~     during the dental treatment. In order to alleviate their dental problems, supervised~     toothbrushing programme and an oral health education talk are proposed. The investigators~     investigate the effectiveness of the supervised toothbrushing programme and an oral health~     education talk. The target group of the study is mild to moderate grade intellectual disabled~     students of special schools in Hong Kong. A clustered randomised controlled trial design is~     adopted.~   "
25421|NCT03234218|"~     Interest in vitamin D has seen an unprecedented revival sparked by the finding that vitamin D~     has pleiotropic effects with an intriguing link to the critically ill patients. The recent~     VITdAL-ICU RCT found a significant difference in mortality in patients with severe deficiency~     when high doses of vitamin D supplementation were administered.~      Vitamin D deficiency is extremely common in patients with chronic liver disease and/or~     cirrhosis. It seems to be a marker of severity of the disease, but also a possible~     contributing factor in determining poor outcomes.~      Design of the study: Observational prospective study. Primary variable end point: Vitamin D~     at baseline, and POD (post-operative day) 1, 3, 7, 28.~      Secondary variable end points: ICU length of stay; SAPS 2 and SOFA score at POD 1, 7; Days of~     mechanical ventilation; Hospital length of stay; Mortality at POD 28; Diagnosed invasive~     infections; Graft rejection in the first 28 days; Bilirubin and INR at POD 7 and 28.~      SAFETY. The patient will not undergo to additional procedure during the study and will be~     asked for consent to treatment of personal data.~      SAMPLE SIZE. Because of the lack of knowledge in this specific cohort no formal sample was~     calculated beforehand. The sample size will be defined by one-year clinical activity: about~     60 consecutive patients.~      STATISTICAL ANALYSIS. All statistical analysis and results will be assessed and reported as~     exploratory analysis. In order to describe the trend over time of the vitamin D levels,~     descriptive statistics such as mean, median, interquartile range and standard deviation will~     be evaluated. In addition, 95% confidence intervals for mean and standard deviation will be~     reported. Comparisons between two temporal observations will be assessed with paired t-test.~     Any univariate association between factors or covariates, will be explored. Statistical~     analyses will be done with SAS 9.4,~   "
25422|NCT03234205|"~     Measurement of T2 transversal relaxation time by magnetic resonance has a major interest in~     cardiac imagery. It has been initially used for quantitative evaluation of heart viability~     and more recently for edema characterization. It allows to prematurely detect a cardiac~     transplant rejection. This technique needs successively around ten FSE sequences during~     apnea. Weak reproducibility of successive apneas and discomfort of patient limit the~     precision of this measurement and consequently its use in standard care. The ARTEMIS study~     method allows the examination during free respiration without prolonging the duration of~     examination compared to the examination during apnea. Moreover, image processing is~     simplified and correction of respiratory movements renders results more reliable.~      This is a pilot study of evaluation of ARTEMIS technique of image reconstruction. ARTEMIS is~     a method of MRI image reconstruction for measurements of T2 transversal relaxation. It allows~     to obtain diagnostic images without movement artifacts.~      The primary objective si to show the feasibility of ARTEMIS method for measurement of~     myocardial T2 relaxation time during free respiration in cardiac transplant patients.~      The secondary objective is to collect quantitative data to compare ARTEMIS method of~     measurement of T2 during free respiration and standard clinical practice during apnea.~   "
25423|NCT03234192|"~     The purpose of this study is to examine the effectiveness of three common techniques for the~     treatment of lateral epicondylosis. Through objective and subjective assessments this study~     will determine the effectiveness of the Astym Treatment Technique, the Graston Treatment~     Technique, and therapeutic ultrasound in the conservative treatment of lateral epicondylosis.~     It is hypothesized that the more manual Astym technique and Graston technique will produce~     more significant results than the more frequently utilized ultrasound.~   "
25424|NCT03234179|"~     Lung cancer is a leading cause of cancer mortality among adults worldwide. The incidence~     rates of lung cancer among never smoking females in some parts of East Asia are among the~     highest in the world. The adenocarcinoma of lung being the most frequently identified~     histological type is more weakly associated with smoking, and often occurs in females and~     never-smokers. Although family history of lung cancer has been associated with histological~     subtypes, the inherited susceptibility factors that affect specific histology are unknown.~      Genetic factors that determine individual predisposition to lung cancer have been identified~     via genome-wide association studies. These known common loci, however, explain only a small~     fraction of the familial risk of lung cancer. The hypothesis of this study is that there are~     genetic factors that confer inherited susceptibility among patients with primary~     non-small-cell lung cancer (NSCLC).~   "
25425|NCT03234166|"~     Acute necrotizing pancreatitis is a frequent and potentially lethal disease, especially in~     case of infected pancreatic necrosis (IPN). IPN usually occurs after the first week of~     evolution. The step up approach is now widely recommended for the management of IPN. In fact,~     in case of suspicion of IPN, a drainage percutaneous or transgastric is recommended at first,~     supported by probabilist antibiotherapy. 1/3 of patients won't require any other~     interventions. For 2/3 of patients, an additional necrosectomy is necessary. Necrosectomy was~     formally realized by open laparotomy. Since de last decade, mini-invasive technics have~     emerged: transgastric necrosectomy, video-assist retroperitoneal debridement. laparoscopy and~     permitted a decreased of morbidity and mortality. Recently, Hollemans et al. developed a~     nomogram based on 4 variables (sex, multi-organ failure, % of necrosis and collections~     heterogeneity) which are negative predictors for success of catheter drainage in IPN with an~     receiver operating characteristic (ROC) curve at 0.76. The aim of this study is to validate~     on a large retrospective cohort Hollemans nomogram in predicting catheter drainage success.~     Secondary aims are to evaluate possible others predictors for success of catheter drainage in~     IPN and to evaluate the impact of antibiotherapy on microbiological results and on the need~     for an additional necrosectomy regarding its type and duration, as well as the emergence of~     multiresistance organism.~   "
25426|NCT03234153|"~     The trial assess the safety and antitumor activity of the anti-PD-L1 antibody Durvalumab in~     combination with the anti-CTLA4 antibody Tremelimumab.~   "
25427|NCT03234140|"~     Follicular lymphoma is the second most common adult B-cell lymphoma. The acquisition of the~     t(14;18) translocation is the genetic hallmark of Follicular lymphoma. However, 50% to 70% of~     healthy individuals harbor low levels of circulating t(14;18)-positive cells but will never~     develop Follicular lymphoma. It was observed that individuals who developed Follicular~     lymphoma showed a higher t(14;18) frequency than controls (Roulland et al., J Clin Oncol~     2014). High t(14;18) frequency in blood from healthy individuals could be a predictive~     biomarker for Follicular lymphoma development. Genetic instability of those t(14;18)+ B-cells~     as well as failure of the micro-environment to control the proliferation of these cells are~     proposed mechanisms linking these lymphoma precursors to true lymphoma cells. The prognosis~     of Follicular lymphoma patients has been significantly improved mainly with the development~     of anti-CD20 monoclonal antibodies, with a current median overall survival over 15 years.~     However, this lymphoma remains an incurable disease. The most commonly used tool for~     prognostication of patients with Follicular lymphoma is the Follicular Lymphoma International~     Prognostic Index (FLIPI) based on conventional clinical and pathology parameters. Although it~     has clinical utility, the Follicular Lymphoma International Prognostic Index does not reflect~     the biologic heterogeneity of Follicular lymphoma. First-degree relatives of Follicular~     lymphoma had a fourfold increased risk of Follicular lymphoma suggesting a genetic etiology.~      Using the Genome wide association studies (GWAS) approach on Follicular lymphoma cohorts of~     1,565 patients, the project plan to identify new prognostic markers. These markers will then~     be analyzed to decipher the impact of host genetics on somatic alterations and tumor biology,~     using public or matched patient data. The investigators also plan to analyze the influence of~     single-nucleotide polymorphisms on circulating t(14;18) levels in 318 healthy individuals~     included in EPIC cohort that will develop Follicular lymphoma later on, and assess if these~     biomarkers are helpful to refine the identification of high-risk Follicular lymphoma~     individuals.~   "
25429|NCT03234114|"~     It is a prospective, multi-centered, pragmatic clinical trial (PCT) which will enroll 800~     acute coronary syndrome (ACS) patients concomitant non-valvular atrial fibrillation (NVAF)~     undergoing new generation drug eluting stent (DES) implantation in China. In the randomized~     control group, subjects will receive triple antithrombotic therapy (TT) including warfarin~     with targeted INR 2.0-2.5, clopidogrel 75 mg per day and aspirin 100 mg per day for 4 weeks~     or 6 months in a randomized way after percutaneous coronary intervention (PCI) with new~     generation DES. Then a dual antithrombotic therapy including warfarin (targeted INR 2.0-2.5)~     and clopidogrel 75 mg per day will be administrated till 12 months after PCI. In the cohort~     group, dabigatran 110 mg b.i.d plus ticargrelor 90 mg b.i.d or clopidogrel 75 mg q.d will be~     dosed for 12 months after PCI. The baseline characteristics of all patients and outcomes in 2~     groups including primary composite endpoints of all-cause death, non-fatal myocardial~     infarction, unplanned revascularization, ischemic stroke, major bleeding (BARC criteria ≥~     3a), and secondary endpoints including death, myocardial infarction, unplanned~     revascularization, stent thrombosis, stroke and bleeding (BARC criteria 1-5) will be~     collected and compared during hospitalization and in 4 weeks (± 7 days), 6 months (± 7 days)~     and 12 months (± 7 days) after inclusion for office visits and in 2 weeks (± 7 days), 2~     months (± 7 days) and 3 months (± 7 days) after inclusion for phone call visits.~   "
25430|NCT03234101|"~     Public health policy is universal in recommending the adoption of low risk low-risk lifestyle~     behaviors for health promotion and prevention of chronic or non-communicable diseases~     (NCDs).These behaviors generally include achieving and maintaining a healthy body weight,~     healthy diet, regular physical activity, smoking cessation, moderate alcohol intake, and~     adequate sleep. While there is a general consensus that adherence to any one of these~     low-risk lifestyle behaviors is associated with benefit, it is not clear if adherence to~     multiple behaviors would result in a larger benefit across different groups of people,~     conditions, and chronic disease outcomes. The Canadian Cardiovascular Society (CCS), as part~     of the Dyslipidemia Guidelines Update, commissioned a series of systematic reviews and~     meta-analyses (a type of knowledge synthesis) using the Grading of Recommendations~     Assessment, Development, and Evaluation (GRADE) approach to quantify the benefit of adherence~     to multiple low-risk lifestyle behaviors in relation to patient-important chronic disease~     outcomes (risk of cardiovascular disease, diabetes, cancer, and death) and assesses the~     quality and strength of the evidence for this benefit.~   "
25431|NCT03234088|"~     As the population ages and medicine advances, there has been a significant shift to the~     management of chronic diseases. Most chronic diseases are managed using evidence based~     consensus guidelines but clinician and patient compliance with these guidelines is~     sub-optimal. In addition, due to the nature of chronic diseases, patients need to make~     long-term lifestyle changes in order to effectively control their disease in order to~     minimize complications, disability and cost. It is these two factors, consistent~     implementation of evidence-based guidelines and supporting patients in a way that encourages~     self-management and lifestyle change, that disease management attempts to impact. There are~     areas of design, implementation, testing and final-result-reporting to the patient and~     clinician that require collaboration among information technology (IT) and software design~     engineers and clinicians to achieve several goals:~        1. Ensure patient safety.~        2. Protect the security and integrity of clinical data.~        3. Provide patient specific education to promote self-management.~        4. Provide actionable data to clinicians in order to improve clinical care and minimize the~          risk of adverse events.~        5. Provide both patient and clinician satisfaction with the system of care.~      In order to achieve these goals, testing and development of home technology under a~     controlled clinical trial is critical.~   "
25432|NCT03234075|"~     Patients with terminal chronic kidney disease (CRD) need renal function supplementation,~     namely dialysis or renal transplantation. Transplantation is the most efficient and~     cost-effective treatment. Early and equitable access to transplantation is a public health~     issue. Access to transplantation is facilitated by early and systematic information and~     assessment of patients for inclusion in the national waiting list for transplantation prior~     to the onset of dialysis, and by the development of transplantation from living donors. In~     France, there are wide disparities in access to national waiting list registration and~     transplantation. One of the causes of these inequalities in access would be the disparity in~     referral practices to a transplant medical and surgical team authorized to register the~     individual on the national waiting list.~      The aim of the TRACE study is to evaluate the impact of a new regional organization promoting~     renal transplantation on access to renal transplantation.~   "
25433|NCT03234062|"~     People who eat diets low in choline (LC) should deplete their choline (Cho) stores, and~     measurements of Cho pool size using isotope dilution should reflect this depletion.~     Investigators will identify a biomarker panel that correlates well with measured Cho pool~     size across the range of different degrees of depletion.The investigators propose that, as~     body stores of Cho diminish, cells and organs will reach the point when metabolism/function~     in the cell is altered, and that this will result in a progression of changes in biomarkers~     that reflect Cho status.~   "
25434|NCT03234049|"~     The use of a pre-arrival and pre-departure trauma checklist to optimize care has not yet been~     studied. The Alberta Children's Hospital (ACH) Trauma Checklist was developed by the ACH~     Resuscitation Council with input from the ACH Trauma Program. The purpose of this study is to~     determine if the introduction of the ACH Trauma Checklist as a cognitive aid, coupled with an~     educational session, will improve clinical performance in a simulated environment. The~     investigators plan to conduct a pilot, randomized control trial assessing the impact of the~     ACH trauma checklist on time to critical interventions on a simulated pediatric patient by~     multidisciplinary teams. The investigators hypothesize that teams who use a trauma checklist~     as a cognitive aid will have faster initiation of key clinical interventions within a~     simulated pediatric trauma resuscitation. Improvements in performance in a simulated~     environment with this tool may translate to similar results in the clinical setting.~   "
25466|NCT03233607|"~     This is a prospective cohort study of patients delivering at Columbia University Medical~     Center/ Allen Hospital. For the primary research question, the investigators will compare the~     change in maternal hemoglobin from postpartum day 1 to day 2 and also determine correlation~     with estimation of blood loss (EBL) and quantitative blood loss (QBL).~   "
25435|NCT03234036|"~     This study will be conducted in two Parts to confirm the acceptability/selection of a tablet~     formulation for future clinical development of GSK2838232. Part 1 of the study will assess~     single ritonavir (RTV)-boosted doses of a new tablet formulation given with food (containing~     approximately 30% fat) against the reference capsule formulation also given with food and~     then will assess the impact of fasted conditions on the tablet performance. In Part 2,~     non-boosted GSK2838232 will be given as once-daily tablet doses for 11 days in a separate~     group of subjects, assuming the tablet performance is considered acceptable from Part 1.~     Approximately 16 healthy subjects will be enrolled to provide at least 12 evaluable subjects~     through the three study periods in Part 1. 10 healthy subjects will be enrolled to provide at~     least 8 evaluable subjects through the single study period in Part 2. The maximum duration of~     study participation will be approximately 9 to 10 weeks for Part 1; and 8 to 9 weeks for Part~     2.~   "
25436|NCT03234023|"~     DESIGN: Controlled clinical trial with single randomization, unmasked, open and unicentric.~      CONDITION TO STUDY: Acute Coronary Syndrome (ACS). INTERVENTION:monitored not supervised.~     MAIN OBJECTIVE: To determine the incidence of major adverse cardiac events, MACE (total~     mortality, new ACS, coronary revascularization, all-cause hospitalization) during the~     one-year period after hospitalization for ACS.~   "
25437|NCT03234010|"~     To determine the rate and amount of nicotine uptake with 10-minute ad libitum use of four~     different marketed electronic cigarettes. Furthermore, to measure overall product liking by~     subjects to assess potential willingness to seek out the Electronic Cigarette (EC) again in~     the future.~   "
25438|NCT03233997|"~     To determine the rate and amount of nicotine uptake with 10-minute ad libitum use of four~     different marketed electronic cigarettes. Furthermore, to measure overall product liking by~     subjects to assess potential willingness to seek out the Electronic Cigarette (EC) again in~     the future.~   "
25439|NCT03233984|"~     Endocrine disruptors are known as a cancer cause. On pregnant women, it can induce major~     foetal pathology and impact growth.~      Among those molecules, bisphenol-A (BPA) is a plasticizer that can be found on cans and~     water.~      Through a prevention program, the investigators tried to warned pregnant women on endocrine~     disruptors exposition risks. The goal here is to assess the effectiveness of this program on~     their fresh products consumption.~   "
25440|NCT03233971|"~     The aim of this study is to study patients' and caregivers' perspectives towards~     deprescribing using the Revised Patients' Attitudes Towards Deprescribing (rPATD)~     questionnaire.~   "
25441|NCT03233958|"~     The purpose of this study is to investigate the psychosocial effects of systemic / family~     constellation. The method of systemic / family constellation refers to an approach which~     integrates ideas from family systems therapy with elements from psychodrama. The~     constellations are conducted in a group based seminar-setting, each seminar lasting two days.~      Considering the very limited amount of empirical data on this method, the study design is a~     simple pre-post one with a 6-months follow-up. The study will be observational: the~     researchers will not manipulate who receives the intervention; instead they invite all~     clients (individuals from the general population) attending these therapeutic workshops run~     independently of the research process. Given the limited amount of evidence on this~     therapeutic method, special attention will be given to monitor potential adverse outcomes to~     establish intervention safety.~      It is hypothesized that participation in a family constellation seminar might decrease~     potential psychological symptoms and will not result in adverse outcomes.~   "
25442|NCT03233932|"~     A randomized, open-label, single dose, parallel design phase I clinical trial to investigate~     the safety and pharmacokinetic/pharmacodynamics of CKD-841 or Leuplin Inj. 3.75mg after~     subcutaneous injection in postmenopausal female.~   "
25443|NCT03233919|"~     The primary objective of the CORIC-MI trial is to evaluate whether comprehensive (per, post~     plus delayed) remote ischemic conditioning (CORIC) as an adjunctive therapy in patients with~     ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary~     intervention (PPCI) can improve left ventricular function and remodeling at 30 days assessed~     by cardiac magnetic resonance imaging (CMR) for a minimum follow-up period of 12 months.~   "
25444|NCT03233906|"~     The purpose of the study is to examine the effect of chia seed consumption on body~     composition, blood pressure, blood glucose, satiety, mood, joint pain, and dietary~     displacement in overweight and obese females (18-45years). It is hypothesized that consuming~     chia seeds will bring about a positive change in body composition (lower % body fat),~     satiety, mood, joint pain, and blood pressure, lower blood glucose levels, increased fiber~     and improved nutrient intake, in overweight/ obese females.~   "
25445|NCT03233893|"~     sixty participants will be divided in to two groups (n=30) of patient treated by partial~     caries removal according to the capping material (A),where (A1)represents calcium silicate~     group,(A2)represent calcium hydroxide group.Apply light activated calcium silicate for group~     (A1) in deep occlusal caries and taking the base line image after restoring the cavity with~     composite restoration and apply light activated calcium hydroxide for(A2)group in deep~     occlusal caries and taking the base line image after restoring with composite~     restoration.Take follow up image after one year to measure the calcific bridge formation for~     both groups.~   "
25446|NCT03233880|"~     This randomized, double blinded controlled trial included 1200 healthy primigravidae who~     attended an outpatient clinic at 16-20weeks of pregnancy. All women were randomly divided~     equally into two groups, group A(600 women) who received antichlamydial treatment in the form~     of azithromycin 1 gram single oral dose before 20 weeks of pregnancy and group B (600 women)~     who received no treatment(placebo). All participants were followed up for up to 6 weeks~     postpartum and observed for the development of preeclampsia.~   "
25447|NCT03233867|"~     This is a non-interventional study in children and adolescents (ages 6-17 years) with~     attention deficit hyperactivity disorder (ADHD) to assess CNVs in specific genes involved in~     glutamatergic signaling and neuronal connectivity. The screening in this study will be~     conducted through a combination of online and site performed activities.~   "
25509|NCT03233048|"~     The reason we are doing this research is to get information about the ORBERA™ Intragastric~     Balloon to learn if it is safe and if it works. We want to learn if older teenagers who are~     overweight will lose weight and if their other medical problems will get better. ORBERA™ is a~     special balloon approved by the FDA for overweight adults, and we would like to try using it~     for overweight teenagers.~   "
25448|NCT03233854|"~     This phase I trial studies the side effects of CD19/CD22 chimeric antigen receptor (CAR) T~     cells when given together with chemotherapy, and to see how well they work in treating~     patients with CD19 positive diffuse large B-cell lymphoma or B acute lymphoblastic leukemia~     that has come back or does not respond to treatment. A CAR is a genetically-engineered~     receptor made so that immune cells (T cells) can attack cancer cells by recognizing and~     responding to the CD19/CD22 proteins. These proteins are commonly found on diffuse large~     B-cell lymphoma and B acute lymphoblastic leukemia. Drugs used in chemotherapy, such as~     cyclophosphamide and fludarabine phosphate, work in different ways to stop the growth of~     cancer cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Giving CD19/CD22-CAR T cells and chemotherapy may work better in~     treating patients with diffuse large B-cell lymphoma or B acute lymphoblastic leukemia.~   "
25449|NCT03233841|"~     The primary objective of this study is to establish the natural history of Farber disease~     (acid ceramidase deficiency) through the collection and analysis of retrospective and~     prospective data on patients diagnosed with Farber disease. All patients diagnosed with~     Farber disease are eligible, including both those who have and have not undergone~     hematopoietic stem cell transplantation (HSCT). Additionally, data and records from deceased~     patients will provide valuable retrospective data for this study.~      The secondary objective of the study is to establish a set of clinical data, laboratory data~     (biomarkers), and functional data potentially useful for:~        -  Assessing the efficacy of HSCT and the efficacy of potential future therapies (for~          example with RVT-801, recombinant human acid ceramidase) in Farber disease~        -  Characterizing changes in symptoms of patients over time~        -  Characterizing distinct groups (phenotypes) within the patient population~        -  Documenting the disease histories of individual patients to serve as intra-subject~          control data for those who may enroll in any future clinical studies with therapies for~          Farber disease~      The exploratory objectives of the study are:~        -  To explore the relationship between patient disease activity or phenotype and specific~          ceramide levels or specific immunologic markers (cytokines/chemokines) in blood~        -  To evaluate a standardized tool, the Farber Disease Natural History Instrument (FDNI),~          to be used for the collection of patient history information, data from clinical,~          laboratory, genetic, and functional studies, and data from review of medical records~   "
25450|NCT03233828|"~     This study is meant to assess the use of intralesional IL-2 to modulate the immunological~     response to suspected melanoma, or melanoma in situ, in an effort to increase lymphocyte~     infiltration and decrease disease metastasis.~      Patients that are clinically diagnosed with suspected Melanoma or Melanoma in situ will be~     assigned to either a treatment or control arm. The treatment group will be subjected to two~     intralesional IL-2 injections, whereas the control group will be subjected to two~     intralesional injections of saline.~      The proteomic and metabolomic profiles of both groups will be analyzed using urine and blood~     samples in an effort to assess the systemic immunological response, if any, to the treatment.~     Also, upon disease confirmation and staging by a qualified pathologist, lesions will be~     assessed for lymphocyte infiltration using immunohistochemical methods.~      This study will determine whether pre-treatment of IL-2 on lesions (clinically diagnosed as~     melanoma or melanoma in situ) is effective in generating an adaptive immune response, and~     whether that immune response may play a role in preventing disease metastasis.~   "
25451|NCT03233815|"~     This study compares the difference in proinflammatory markers Interleukin 6 (IL-6), Tumor~     necrosis factor alpha (TNFα) and cortisol in patients undergoing cardiovascular surgery to~     asses if there is a benefit of using intravenous total anesthesia (TIVA) over inhaled~     anesthesia for this procedures.~   "
25452|NCT03233802|"~     The object of this study is to develop a treatment for alcohol use disorders that is more~     effective than current CB treatments. Through a 2009 R-21 pilot project the investigators~     developed a cognitive-behavioral (CB) treatment that employed cellphone-based experience~     sampling (ES) to collect detailed patient data, in near real-time, and that used those data~     to direct treatment for each patient based on his/her pattern of drinking and specific coping~     actions during high-risk situations. ES data included momentary assessments of situations,~     thoughts and feelings antecedent to drinking episodes, and the use of coping skills. That~     initial study of the Individualized Assessment and Treatment Program (IATP) showed promise.~     The present study is intended to extend the earlier findings, to compare IATP to a more~     active control treatment, and to evaluate long-term outcomes.~   "
25453|NCT03233789|"~     The aim of this mixed-methods-study is to develop and validate an algorithm to transform FIM~     (Functional Independence Measure) and EBI (Extended Barthel Index) into an ADL score~     (Activities of Daily Life) that can be used to compare outcome quality of rehabilitation~     clinics.~      The following steps are performed:~        1. Development of an ADL-algorithms by experts~        2. Validation of the ADL-algorithms in a quantitative approach~        3. Finalization of the ADL-algorithms by experts based on study results~   "
25454|NCT03233776|"~     Oral and intestinal mucositis are major risk factors for the occurrence of fever during~     neutropenia and bloodstream infections after intensive chemo- and radiotherapy. These~     complications often require dose reductions or cause delay of treatment, and thereby~     interfere with optimal anticancer treatment. Currently, there are no effective strategies to~     prevent or treat mucositis and the related complications.~      The pro-inflammatory cytokine interleukin-1β (IL-1β) has shown pivotal in the pathogenesis of~     mucositis and recently, it has been established in murine models that IL-1 inhibition~     significantly ameliorates chemotherapy-induced intestinal mucositis.~      In this phase IIa study the safety, maximum tolerated dose and efficacy of anakinra, a~     recombinant human IL-1 receptor antagonist, will be determined in adult patients with~     multiple myeloma who receive high-dose melphalan (HDM) in the preparation for an autologous~     hematopoietic stem cell transplantation (ASCT) and are at high risk for experiencing~     mucositis and fever during neutropenia (FN). After establishing the optimal dose, a pivotal~     double-blind randomized placebo-controlled multicenter phase IIb trial will be planned to~     establish efficacy.~   "
25455|NCT03233763|"~     Ongoing laboratory work into the pathology of Leukaemia:~   "
25510|NCT03233035|"~     To evaluate the efficacy and safety of early administration of low-dose intranasal ketamine~     analgesic agents in patients with moderate to severe pain in the ED in reducing the need for~     opioid or class III analgesic agents.~   "
25511|NCT03233022|"~     Participants complete an 8-week program and complete assessment measures to track their~     outcomes over time.~   "
25456|NCT03233750|"~     Previous research has shown that health professionals can experience stress responses during~     high acuity events such as trauma resuscitations. These stress responses can lead to impaired~     clinical performance. The goal of this proposed project is to adapt Stress Inoculation~     Training (SIT) to the healthcare setting. Stress Inoculation Training is a~     cognitive-behavioural approach to stress management that has proven effective in reducing~     stress and improving performance in domains outside of healthcare.~      Thirty-two emergency medicine residents will be randomly divided into two groups. The SIT~     group will receive the simulation-based stress inoculation training. We will measure the~     effectiveness of the training by looking at reduction of stress levels and improvements in~     clinical performance in a pre-intervention and a post-intervention simulated trauma scenario.~     The control group will be exposed to the same simulation scenarios and pre/post intervention~     scenarios as the SIT group, but will not receive the stress inoculation training.~   "
25457|NCT03233737|"~     The purpose of this study is to determine if the topical application to gingival tissue of~     the combination of benzocaine and tetracaine has a longer duration of local anesthetic~     activity than benzocaine alone.~   "
25458|NCT03233724|"~     Background:~      Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. Lung cancer is the~     leading cause of cancer-related death in the United States. Most people with lung cancer are~     already in the advanced stages of the disease by the time they see a doctor. Researchers want~     to see if combining an approved drug with two new drugs can help.~      Objective:~      To study if tetrahydrouridine-decitabine (THU-DAC) with pembrolizumab is safe and effective~     in people with non-small cell lung cancer that cannot be removed by surgery.~      Eligibility:~      People 18 years and older who have NSCLC that cannot be removed by surgery~      Design:~      Participants will be screened with~        -  Medical history~        -  Physical exam~        -  Blood and urine tests~        -  Tests of heart and lung function~      They may have a small tumor sample taken (biopsy). They may have tumor scans.~      Before starting treatment, participants will repeat the screening tests. They will also give~     a stool sample.~      The study will be done in 3-week cycles for up to 6 cycles.~        -  Participants will take the 2 study drugs by mouth 3-5 days a week.~        -  Participants will get pembrolizumab in a vein for 30 minutes 1 day each cycle.~      Participants will keep a study medication diary.~      During cycle 1, participants will have blood taken multiple times on days 1 and 2.~      Every 3 cycles, participants will repeat screening tests.~      Participants will have a mandatory tumor biopsy.~      When they finish treatment, participants will have a physical exam and blood tests.~   "
25459|NCT03233711|"~     This randomized phase II clinical trial studies how well nivolumab after combined modality~     therapy works in treating patients with high risk stage II-IIIB anal cancer. Monoclonal~     antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and~     spread.~   "
25460|NCT03233685|"~     Tennis is situational sport in which the result of the game is directly influenced by the~     interaction with the opponent. In fact, athletes have to respond in a short-time period to~     change the way of playing by fast analyzing speed, rotation and direction of the tennis ball.~     Therefore, it is extremely complicated to predict exactly what will happen during games and~     matches. According to literature goof visual skills, players can receive and process~     information quickly and can optimize the performance with extreme precision and dexterity.~     For this reason, visuomotor training aims to improve reaction times, but its efficiency~     during playing tennis has not yet been investigated. Therefore, the aim of this study is to~     investigate how this training method could affect the improvement of visuomotor performance~     in young people between 12 and 18 years old.~   "
25461|NCT03233672|"~     To report the outcome of hypo-fractionated radiotherapy after radical prostatectomy (RP) for~     prostate cancer (PCa) using IMRT-SIB. 124 patients with PCa at high risk of relapse after RP~     or diagnosis of biochemical relapse were included. Patients received 62.5 Gy to the prostate~     bed (PB) and 45 Gy to pelvis nodes in 25 fractions. Androgen suppressive therapy was~     prescribed based on NCCN risk categories. Median follow-up was 30 months.~   "
25462|NCT03233659|"~     Graft versus Host disease ( GVHD) is one of the major complications of Allogeneic Stem Cell~     Transplantation. Acute GVHD develops early ( within 2to 3 months) after transplantation and~     is the leading cause of death of transplanted patients. The pathogenesis of Chronic GVHD is~     still little known. Chronic GVHD is caused by donor T lymphocytes, but we have no precise~     knowledge on the participation of specific subsets of immune system cells to chronic GVHD. In~     general, chronic GVHD is associated with an increase in the number of T effector lymphocytes,~     both helper type 2 and cytotoxic.~      Recently, also antigen presenting cells (APCs) have been implicated in pathogenesis of~     chronic GVHD in studies performed on animal models. T lymphocyte responses that characterize~     chronic GVHD require that recipient antigens are submitted by APCs which originate from the~     donor's HSC ( Hematopoietic Stem Cells) APCs are heterogeneous population that includes~     dendritic cells (DCs) ,monocytes, activated B lymphocytes and CD34+ cell subpopulations.~     These cells can be identified by cytometry.~      The data about APCs role in chronic GVHD are preliminary and often discordant. Seemingly,~     there isn't correlation between circulating APCs number and risk of cGVHD. However, recent~     data of our group show that patients with cGVHD could have higher number of monocytes in bone~     marrow than transplanted patients without cGVHD.~      The aim of study is to measure the number of circulating immune cells in the PB (peripherical~     blood) before and after Allogeneic Hematopoietic Stem Cell Transplantation by flow cytometry.~   "
25463|NCT03233646|"~     This study aims to develop and evaluate biomarkers using non-invasive optical coherence~     tomography angiography (OCTA) to assess the structure and function of the retinal~     microvasculature in persons with mild cognitive impairment (MCI) and Alzheimer's Disease (AD)~   "
25464|NCT03233633|"~     Study Objectives: Primary reduction of pain and reduction in overall opioid utilization.~     Secondary improvement in overall patient well being, weight stabilization with increased~     appetite, improved oxygen saturation, improvement or prevention of nausea and vomiting.~      Study Rationale: To determine optimum use and dosing of medical marijuana (CBD:THC) for pain~     and symptom management.~      Study Population: This study specifically will enroll cancer and non-cancer patients as a~     primary diagnosis suffering from pain and having a terminal illness (defined as having less~     than 6 months to live) requiring end of life care.~   "
25512|NCT03233009|"~     To assess the irritation potential of four prototype daily defense serum formulations after~     24 (± 2) hours under semi-occlusive patch application to the skin of healthy volunteers.~   "
25467|NCT03233594|"~     Central nervous system (CNS) changes associated with pain have been difficult to measure~     until the development of functional neuroimaging techniques such as positron emission~     tomography (PET). We have previously observed asymmetry in the thalamus associated with~     chronic pain that altered during acupuncture therapy. Imaging studies of therapeutic~     techniques for chronic pain in animals and humans have been quite limited. This study will be~     the first to utilize FDG PET-MRI imaging of both the brain and body in order to assess CNS~     changes and peripheral body changes related to chronic pain and its potential management.~   "
25468|NCT03233581|"~     The Primary Goal is to conduct a 12 week pilot randomized controlled trial (RCT) of the~     Fitbit Flex, a popular, affordable, wearable physical activity tracking device, and the~     Fitbit mobile health (mHealth) app. The target population will be cancer survivors 18-39~     years old recruited from the Seattle Cancer Care Alliance. For the intervention group, peer~     influences will be engaged via a private, social network (e.g. a Facebook group) customized~     for survivors. Measurements will be completed (1) at baseline, prior to randomization, and~     (2) during the final week of the intervention period (follow-up measure). This pilot study~     will provide initial proof of concept and allow for further customization of the intervention~     for cancer survivors in anticipation of a future, larger proposal to study physical activity~     and related outcomes over a multi-year period.~      Besides conducting exploratory analyses of primary and secondary outcomes for this pilot RCT,~     we also specify feasibility criteria including: (1) recruiting 50 cancer survivors ages 18-39~     years and between 1.0-5.0 years from the completion of active cancer therapy, (2)~     intervention participants wear the Fitbit Flex on the majority of all intervention days~     during the 12-week intervention period, and (3) ≥75% of all participants complete online~     questionnaire data collection at Time 1 and Time 2.~   "
25469|NCT03233568|"~     The investigators will retrospectively analyze and compare data of 2 groups of overweight and~     obese patients: subjects who followed a diet based on Resting Energy Expenditure (REE)~     measured by indirect calorimetry and subjects who followed a diet based on REE estimated by~     the Harris-Benedict equation. Propensity score adjustment will be used to adjust for known~     differences between the 2 groups~   "
25470|NCT03233555|"~     This study tests four different methods of educating patients about follow-up care (NCI~     facing forward, brochure, EXCELS website alone, EXCELS health coaching alone and EXCELS~     website & health coaching combination) after cancer treatment ends. While it is known that~     patients need information to guide follow-up it remains unknown how to best provide this in~     primary care.~   "
25471|NCT03233542|"~     The aim of the study is to examine panic-related associations and interpretations in the~     context of Panic Disorder and its treatment. While theoretical accounts of Panic Disorder~     suggest a central role of such associations and interpretations in the onset and maintenance~     of the disorder, research to date in fact leaves many questions about the nature of these~     dysfunctional cognitions and their potential role unanswered. Patients with Panic Disorder~     and a control group of patients with other anxiety disorders will complete measures of~     panic-relevant associations and interpretation bias. The patients with Panic Disorder will be~     randomized to receive either Cognitive Behaviour Therapy (CBT) or a waiting list condition~     (to be followed by CBT after completion of the study procedures). The anxious control group~     will also receive CBT. Panic-relevant associations and interpretations will be measured~     twice, i.e., pre and post CBT/waitlist. Furthermore, relevant symptom measures and~     physiological and biological markers will be assessed and responses to a hyperventilation~     challenge. The study aims to further advance our understanding of cognitions in the etiology~     and maintenance of Panic Disorder, and inform future treatment optimisation.~   "
25472|NCT03233529|"~     This study is being conducted to characterize the mechanism of action of crisaborole ointment~     2%, by evaluation of efficacy and changes in key skin biomarkers in atopic dermatitis (AD)~     lesions treated with crisaborole ointment 2% over vehicle, in subjects with mild to moderate~     AD. Two identified AD skin lesions for each subject will be treated for the first 15 days,~     one with crisaborole ointment 2% and one with vehicle, in a blinded manner, and biopsies for~     biomarker analysis will be performed on the lesions. Following completion of the blinded~     treatment period, subjects will start the 28 day open label period during which all AD~     affected skin lesions will be treated with crisaborole ointment 2% twice daily.~   "
25473|NCT03233516|"~     The overall aim of the TREND study is to improve the differential diagnosis of bacterial and~     viral etiology in children below 5 years of age with clinical community acquired pneumonia.~      Specific objectives:~        -  To assess the diagnostic accuracy of MxA for viral CAP (sub-study I)~        -  To study etiologies in children with CAP (sub-study II)~        -  To evaluate sensitivity and specificity for MariPOC® Respi test versus PCR for detection~          of respiratory viruses (sub-study III)~        -  To assess sensitivity and specificity for a novel RPA-based point-of-care test versus~          PCR for detection of respiratory viruses (sub-study IV)~        -  To assess long-term complications in children with CAP (sub-study V~      The study takes place at Sachs' Children and Youth hospital in Stockholm.~   "
25474|NCT03233503|"~     Food is selected primarily on their taste and texture properties. It is essential to get more~     insight in taste and texture characteristics of the foods in the Dutch and Malaysian diets~     for a better understanding of food choices. Currently, there is insufficient information on~     taste and texture properties of foods to relate these properties to the composition of diets~     and individual food choice in larger (observational) studies.~      In the current study, the investigators want to assess the perceived intensities of the 5~     basic tastes, i.e. sweet, salt, sour, bitter and umami, as well as fat sensation and texture,~     in an array of about 1,000 often consumed Dutch and Malaysian foods. The investigators aim to~     do this with a trained sensory panel, which is a well-accepted way of assessing perception of~     sensory attributes.~      With the current study, the investigators aim to build a table, which is comparable to the~     food composition table, but contains data that describes foods and meals in terms of sensory~     properties. That is, investigators want to quantify sensory characteristics of about 1,000~     commonly eaten Dutch and Malaysian foods. This enables investigators to add sensory~     information to the food intake data that is already being collected in observational studies,~     and to further understand food choices in specific populations, such as elderly and patient~     groups. In current project, the investigators also aim to compare the Dutch diet to the~     Malaysian diet in term of sensory properties.~   "
25475|NCT03233490|"~     The overall aim of this thesis is to identify the factors that may affect 13 year old~     students' acquisition of CPR skills and their willingness to act. The primary hypothesis is~     that the training method (intervention) influences the participants' acquisition of practical~     CPR skills and willingness to intervene.~      The study used a cluster randomized design, based on a randomization list generated by an~     independent statistician. The school classes were randomly assigned to different CPR training~     interventions.~      A strategic sample, where invitation to participate in the study was sent to the headmasters~     of all council schools, with seventh grade students, in two Swedish municipalities (140,000).~     Thus, the sample consists of participants with different cultural as well as socio-economic~     background. Eighteen of 24 schools agreed to participate. Four schools did not respond and~     two schools had a routine to offer CPR education only for grade nine (all six schools from~     the same municipality). The eighteen schools who agreed to participate consisted of~     sixty-eight classes with 1547 students.~      Prior to study participation, students and their guardians obtained a letter with study~     information. Study participation of the individual students was voluntary and all~     participants gave an oral informed consent.~      Inclusion criteria: seventh grade student in one of the participating schools. Exclusion~     criteria: student does not want to participate, student with a physical handicap that limited~     the physical performance, classes of students with development disabilities (these classes~     are age-integrated and have fewer students per class).~   "
25476|NCT03233477|"~     Posner-Schlossman syndrome, or glaucomatocyclitic crisis, is a condition characterized by~     recurrent, acute attacks of mild, nongranulomatous, anterior uveitis accompanied by markedly~     elevated intraocular pressure. Most of patients are the 20 to 50-year-old young adults, with~     unilateral eye involvement. PSS was originally deemed benign, but is now recognized as a~     relatively rare cause of chronic secondary glaucoma,especially in patients with recurrent~     episodes. This relatively rare disease is likely the result of the infections of a variety of~     organisms, and the bulk of literature supports the cytomegalovirus (CMV) as the leading~     cause.~      This study is an observational study that does not interfere with the normal clinical~     diagnosis and treatment process. The investigators in this study focus on observing the~     clinical symptoms and outcome of PSS, analyzing the factors that affect the prognosis of PSS,~     studying the association of its pathogenesis with the psychological status and the behavioral~     types of PSS patients; exploring the relationship between infection (CMV, HSV, Hp) and PSS;~     and studying the changes of local and systemic cytokine expression and its significance in~     patients with PSS.~   "
25477|NCT03233464|"~     - One single operator will assess the prevalence of molar incisor hypomineralization and its~     Severity among a group of Egyptian children .~   "
25478|NCT03233451|"~     The study aims to explore the effectiveness of psycho-behavioral intervention on depressive~     symptoms among older adults with chronic heart failure. Meanwhile, the effect on cardiac~     function and quality of life will also be explored.~   "
25479|NCT03233438|"~     The purpose of this study is to assess the effect of a new critical pathway (use of~     guideline-based patient identification criteria and for those who meet these criteria, use of~     dalbavancin) compared to usual care for the treatment of ABSSI (Acute Bacterial Skin and Skin~     Structure Infections)~   "
25480|NCT03233425|"~     The aim of this pilot project is to disseminate multiprofessional group programs (*MGP*) for~     therapy of the estimated 119'140 overweight/obese children in Switzerland. Family-based~     behavioral MGPs have been implemented from 2009 to 2013 to determine changes of health and~     family behaviours, after the intensive phase (*T1*), at 1 and 2 years after start (*T2*,~     *T3*). MGP costs are reimbursed in Switzerland: 1) if 116 sessions are provided by experts in~     physical activity, nutrition and psychology; 2) if parents are included and if their~     adherence is higher than 85%. In the nationwide Evaluation of Multiprofessional Group~     Programs for Paediatric Obesity Therapy (*KIDSSTEP*) study, multiple psychosocial and~     physical parameters were assessed at T0, T2 and T3 . Out of 33 certified centers, 25 were~     active and only 19 were re-certified in 2013/2014. Obese children suffer from major~     co-morbidities and therefore, only one third of referred patients can be treated in MGPs and~     their beneficial effects on obesity as well as physical and mental health outcomes are~     sustained over 2 years.~   "
25481|NCT03233412|"~     Cervical cancer is one of the leading malignancies affecting women, with 266,000 deaths in~     2012, most of them seen in underdeveloped countries. This neoplasm has a pre-invasive state,~     such as cervical intraepithelial neoplasia (CIN), which is caused by HPV (Human~     Papillomavirus) infection. The female organism most often is able to eliminate the virus,~     especially in young patients. However, when the infection becomes persistent, especially for~     subtypes 16 and 18, the risk of CIN developing an increased. Cytological screening programs~     can efficiently and wirelessly do this. As high-grade intraepithelial lesions (CIN 2/3) are~     as demonstrated by worse regression rate, only 13.3% at one year, and higher risk for~     progression to invasive cancer. As CIN 2/3 need treatment, and as more therapies as they are~     excisional, which theoretically are better, however, they may compromise the reproductive~     future of women who are unthreatened, increasing the risk of preterm labor, premature rupture~     of amniotic membranes, low weight Birth and perinatal mortality. This relationship aroused~     interest in seeking alternative therapies. Decrease antiviral activity directed against HPV,~     associated with a higher rate of elimination of the infection. Immediate, an agent that~     stimulates like dendritic cells to producer cytokines and activates epithelial T cells.~     Imiquimode, when used in vulvar neoplasias, has been shown to be effective, presenting~     satisfactory results without treatment of CIN 2/3 of the uterine cervix, requiring a better~     scientific compilation. Based on these data, this study aims to evaluate the efficacy of~     topical immunomodulatory treatment for high-grade cervical intraepithelial lesions.~   "
25482|NCT03233399|"~     The purpose of this protocol is to learn about movement intention and volition. To improve~     such knowledge, investigators will conduct sub-studies using multiple non-invasive~     methodologies. These results could provide preliminary data for subsequent studies evaluating~     local and global efficacy of plasticity-inducing treatments for PMD symptoms.~   "
25513|NCT03232996|"~     Examining the feasibility and acceptability of the computer game based rehabilitation system~     for improving balance, gait and executive function in individuals with PD. This will involve~     a pilot case series intervention study of individuals with PD will be conducted.~   "
25483|NCT03233386|"~     Sharp increases in substance use rates among youth in Mexico are a major concern, both in~     Mexico and the US. Although the Mexican government has elevated substance abuse prevention as~     a national priority, there are few school-based universal prevention programs to choose from~     that are culturally grounded, empirically tested, and shown to be efficacious. This study~     aims to address this gap by adapting, implementing, and testing the keepin' it REAL (kiR)~     prevention intervention in Mexico's three largest cities: Mexico City, Guadalajara, and~     Monterrey. kiR is a model program for middle school students on the US National Registry of~     Effective Programs and Practices, shown to be efficacious and cost-effective in reducing~     substance use among large multi-ethnic and Mexican American samples in the US. The proposed~     study will leverage the bi-national research team's expertise in developing and adapting kiR~     and build upon a series of feasibility studies across Mexico which showed that kiR's core~     elements are applicable there. However, evidence also suggested that further adaptation is~     needed to enhance the intervention's cultural fit. During the proposed study's Phase 1,~     students and teacher-implementers in three schools—one from each of the cities—will provide~     feedback about the original curriculum and identify culturally and contextually relevant~     scenarios and examples. The bi-national research team—including original kiR curriculum~     designers—will collaborate to ensure cultural applicability in Mexico and fidelity to core~     elements of kiR. In Phase 2, the efficacy of the culturally adapted Mexican version of kiR,~     relative to the original version of kiR and to a control condition, will be tested through an~     intent-to-treat analysis in a randomized controlled trial with 7,768 7th grade students in 36~     middle schools, 12 from each city. The study will investigate and incorporate into the~     curriculum gender specific experiences with drug offers and appropriate drug resistance~     strategies in the Mexican context that may impact the youths' risk of substance use and their~     responsiveness to prevention programs. In light of rising violence in Mexico, a secondary aim~     of the study is to investigate how youths' perpetration, victimization, and witnessing of~     violence may moderate the efficacy of kiR in Mexico. The study will create knowledge relevant~     to efficacious prevention approaches for Mexican-heritage youth on both sides of the~     US-Mexico border. Prevention science will be advanced by understanding how culturally~     influenced gender norms affect substance use offers, attitudes, and behaviors, as well as the~     success of universal prevention programs. In addition, the study will add to knowledge on how~     to execute collaborative, cross-national, translational prevention intervention research.~   "
25484|NCT03233373|"~     Currently, there are no tools that can measure nasal airflow in an objective manner that is~     non-invasive to the patient. This clinical study aims to address this by evaluating the use~     of thermal imaging as a diagnostic tool for measuring nasal airflow.~      Proper airflow cools the nasal airway as it passes--obstructions or narrowed airways hinder~     flow and results in elevated temperatures along the airway and nasal tissue. It is this~     elevation in temperature, or more specifically, loss of cooling, that we hypothesize to be~     measurable with thermal imaging. Participants in this study will be asked to perform 3-4~     nasal breathing cycles which will be recorded by the thermal imager.~   "
25485|NCT03233360|"~     This registry is designed as a multi-centre longitudinal cohort study of patients diagnosed~     with HCC between 1st January 2013 and 30th June 2018 in nine countries (ie, Korea, Taiwan,~     Thailand, Japan, China, Hong Kong, Australia, New Zealand and Singapore). Approximately 30%~     of the sample size will be identified retrospectively and 70% will be identified~     prospectively from the start date of the registry (October 2016), with an even distribution~     of consecutively diagnosed patients within the different years.~   "
25486|NCT03233347|"~     This phase II trial evaluates how well AVD (doxorubicin hydrochloride, vinblastine,~     dacarbazine) in combination with brentuximab vedotin and nivolumab work in treating patients~     with stage I-II Hodgkin lymphoma. Drugs used in the chemotherapy, such as doxorubicin~     hydrochloride, vinblastine, dacarbazine, and brentuximab vedotin, work in different ways to~     stop the growth of cancer cells, either by killing the cells, by stopping them from dividing,~     and/or by stopping them from spreading. Targeted agent, such as nivolumab, may interfere with~     the ability of cancer cells to grow and spread by enhancing the immune system. Giving~     doxorubicin hydrochloride, vinblastine, dacarbazine, brentuximab vedotin, and nivolumab may~     improve survival of patients with stage I-II Hodgkin lymphoma.~   "
25487|NCT03233334|"~     The Purpose Project intervention is an 8-session progressive structure that was developed~     based on theoretical and scientific evidence from psychology and occupational therapy. The~     goal of the intervention is to provide participants with information, tools, and support that~     help them move towards reclaiming a sense of self-grounded purpose in daily life. The study~     will use a convenience sample of women with breast cancer to evaluate the feasibility of the~     Purpose Project intervention in terms of demand/acceptability, implementation, and~     limited-efficacy testing. Findings will be used to inform a later study to evaluate the~     efficacy of the Purpose Project intervention.~   "
25488|NCT03233321|"~     The study evaluate the effectiveness of dry cold application on pain intensity and bruise at~     the subcutaneous injection site among patients admitted in medical I.C.U. Purposive sampling~     technique was used to select 60 hospitalized patients (30 in experimental and 30 in~     comparison group). Dry cold was applied to the subcutaneous injection site using ice bag~     filled with crushed ice with half table spoon of salt for 20 minutes after the administration~     of injection and no intervention was given in comparison group.~   "
25489|NCT03233308|"~     To evaluate the effect on trabecular outflow facility of Netarsudil ophthalmic solution 0.02%~     compared to placebo~   "
25490|NCT03233295|"~     A Prospective, Single-centre, Open-label Study to Confirm the Efficacy and Safety of Vitamin~     D3 B.O.N. Intramuscular Injection in adults with Vitamin D Deficiency~   "
25491|NCT03233282|"~     Identify, characterize and then validate electrophysiological markers linking~     electrophysiological cerebral activity and performance in cognitive and physical fatigability~     in humans. To do this, noninvasive explorations of electroencephalography (EEG) and~     magnetoencephalography (MEG) will be carried out under two conditions of different~     experiments, the first one that induces a cognitive fatigability and the second one that~     induces physical fatigability.~   "
25505|NCT03233100|"~     Constipated patients often have mental problems such as depression and anxiety due to~     difficult defecation. Our previous studies have proved the efficacy of FMT treating~     constipation. Meanwhile it is believed that mental diseases are correlated to gut microbiota.~     This trial is based on the theory of the gut-brain-microbiota axis. Patients with~     constipation, depression and/or anxiety are performed FMT, laboratory, imaging and microbiota~     examinations, and clinical follow-up, to observe the clinical efficiency of FMT and the~     potential role of gut microbiome in these gut-brain disorders.~   "
25506|NCT03233087|"~     The registry study aims to determine serial biomarkers to diagnosis and prognosis of aortic~     aneurysm/aortic dissection.~   "
25507|NCT03233074|"~     It is of clinical significance to better characterize the intrinsic defects harbored by~     mesenchymal stromal cells (MSC) in Myelodysplastic syndromes (MDS) and acute myeloid leukemia~     (AML) context, as compared to physiological conditions. Such research initiative aims to~     dissect the cross-talk between malignant hematopoietic stem cells (HSC) and their bone marrow~     (BM) partners in crime, further prospecting for innovative stromal-directed strategies for~     the treatment of Myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML).~   "
25492|NCT03233269|"~     The purpose of this study is to investigate the effects of the BEATS music therapy program on~     the self-efficacy, trust, knowledge, and adherence of young adult patients with SCD.~      Primary Hypotheses:~      Compared to baseline, young adult patients with SCD who receive the music therapy~     interventions will report:~      Higher sickle cell self-efficacy as measured by the Sickle Cell Self Efficacy Scale (SCSES),~     Higher trust in health care providers as measured by the Wake Forest Trust in the Medical~     Profession Scale, and Higher SCD knowledge as measured by the Seidman Sickle Cell Knowledge~     Quiz.~      Secondary Hypotheses Compared to the one year prior to the study period, young adults with~     SCD who receive the music therapy interventions will have a higher rate of adherence to~     clinic appointments during the one-year study period.~      Additional Questions Do music therapy interventions influence the rate of hospital~     utilization as measured by ED visits, Acute Care Clinic (ACC) visits, and admissions during~     the study period compared to the previous year? Do music therapy interventions influence~     adherence to hydroxyurea therapy for patients receiving hydroxyurea as measured by change in~     mean corpuscular volume (MCV) during the study period? Do music therapy interventions~     influence adherence to iron chelation therapy for patients receiving iron chelation therapy~     as measured by ferritin count during the study period? Does the schedule of music therapy~     interventions in this study improve outcomes more significantly than the schedule of music~     therapy interventions from [IRB# 03-15-30]?~   "
25493|NCT03233256|"~     This study proposes to demonstrate the feasibility of measuring 2H:1H and 18O:16O in saliva~     and breath by comparing the natural abundances of 2H:1H and 18O:16O in saliva and urine of~     un-dosed humans.~   "
25494|NCT03233243|"~     Atherosclerotic plaque uptake of 18F-sodium fluoride (NaF) in positron emission tomography~     with computed tomography (PET-CT) was recently shown to correlate with clinical instability~     in patients with CV disease. We hypothesize that rosuvastatin reduces 18F-NaF plaque uptake.~      Our group will scan coronary, aortic and carotideal arteries of high-risk CV subjects with~     18F- NaF-PET-CT. Individuals with 18F-NaF-positive plaques will be treated with rosuvastatin~     for six months, followed by 18F-NaF-PET-CT re-evaluation.~   "
25495|NCT03233230|"~     The purpose of the study is to determine the efficacy, dose response, and safety of~     evobrutinib in subjects with Rheumatoid Arthritis (RA), and to consider a dose to take~     forward into Phase III development.~   "
25496|NCT03233217|"~     This phase I/II, randomized, modified double-blind, multi-center study will assess the safety~     and immunogenicity of a high-dose quadrivalent influenza vaccine (QIV-HD) in older adults~     (≥65 years).~   "
25497|NCT03233204|"~     This phase II Pediatric MATCH trial studies how well olaparib works in treating patients with~     solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with defects in deoxyribonucleic~     acid (DNA) damage repair genes that have spread to other places in the body and have come~     back or do not respond to treatment. Olaparib may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth.~   "
25498|NCT03233191|"~     This randomized phase III trial studies digital tomosynthesis mammography and digital~     mammography in screening patients for breast cancer. Screening for breast cancer with~     tomosynthesis mammography may be superior to digital mammography for breast cancer screening~     and may help reduce the need for additional imaging or treatment.~   "
25499|NCT03233178|"~     The primary objective of this study is to investigate the change in Alanine Aminotransaminase~     (ALT) in patients with Type 2 Diabetes Mellitus (T2DM) initiating Sodium Glucose~     Cotransporter 2 (SGLT2) inhibitors, liraglutide, or sitagliptin, compared to a control group~     of patients who did not initiate a new antihyperglycemic therapy. The hypothesis is that~     patients using Sodium Glucose Cotransporter 2 inhibitors (SGLT2i) will achieve a greater~     reduction in ALT compared to the control group.~   "
25500|NCT03233165|"~     Oral leukoplakia is a precancerous lesion with relatively high malignant transformation~     potential. They are often treated by wide surgical excisions or conservative retinoids~     therapy. The use of high power ablative lasers has been proposed as an effective way of~     treating these lesions safely. The aim of this study was to evaluate efficiency Er:YAG and~     Er,Cr:YSGG laser, in the treatment of oral leukoplakia.~   "
25501|NCT03233152|"~     Phase I clinical trial on intra-tumoral ipilimumab plus intravenous nivolumab following the~     resection of recurrent glioblastoma.~      The aim of this clinical trial is to exploit the potential synergy of combined intra-tumoral~     CTLA-4 and systemic PD-1 blockade while minimizing the risk for increased immune-related~     toxicity by intratumoral administration of the CTLA-blocking mAb ipilimumab following the~     resection of the recurrent glioblastoma.~   "
25502|NCT03233139|"~     The primary objective of the study is to assess the safety, tolerability, and~     Pharmacokinetics (PK) of REGN2810 as monotherapy in Japanese patients with advanced~     malignancies. The secondary objective of the study is to assess the immunogenicity of~     REGN2810.~   "
25503|NCT03233126|"~     The purpose of the study is to assess the efficacy and safety of KRN23 administered~     subcutaneously once every 2 weeks in children with X-linked hypophosphatemic~     rickets/osteomalacia(XLH)~   "
25504|NCT03233113|"~     Exposure-based cognitive-behavioral therapy (i.e., exposure therapy), which entails~     repeated and prolonged confrontation with feared situations/stimuli, is the most effective~     treatment for anxiety disorders (e.g., arachnophobia). Safety behaviors are actions performed~     to prevent, minimize, or escape a feared catastrophe and/or associated distress (e.g.,~     wearing thick shoes or gloves when around areas where there might be spiders). It is~     understood that safety behaviors contribute to the development and maintenance of anxiety~     disorders; accordingly, patients' safety behaviors are traditionally eliminated as soon as~     possible during exposure therapy (i.e., response prevention). Unfortunately, not everyone~     who receives exposure therapy benefits from this approach. To address the limitations of~     exposure's effectiveness, some experts have questioned the clinical convention of response~     prevention during exposure therapy. Specifically, they propose the judicious use of safety~     behaviors: the careful and strategic incorporation of safety behaviors during exposure~     therapy. The controversial role of permitting safety behaviors during exposure has garnered~     substantial research attention, yet study findings are mixed. The current study, therefore,~     was designed to improve upon the methodological limitations of previous related research and~     examine the relative efficacy of traditional exposure with response prevention (E/RP) and the~     experimental exposure with the judicious use of safety behaviors (E/JU) in a sample of adults~     with arachnophobia. In light of previous related research, several hypotheses were made~     regarding the short- (posttreatment) and long-term (1-month follow-up) treatment effects:~        1. Primary outcomes: E/RP participants will demonstrate greater improvement in spider~          phobia than the E/JU participants along behavioral and self-report symptom measures at~          follow-up.~        2. Secondary outcomes: Treatment acceptability and tolerability will be higher for E/JU~          participants, relative to E/RP participants, before beginning exposures and at~          posttreatment, but not at follow-up. In addition, hypothesize that E/RP participants~          will report greater reductions in peak distress and greater improvements in distress~          tolerance relative to E/JU participants at follow-up.~        3. Additional outcome: Exploratory analyses will be conducted to compare the relative rate~          of behavioral approach and exposure goal completion between treatment conditions.~   "
25514|NCT03232983|"~     This study evaluates a new formulation of insulin lispro, LY900014, a drug that lowers blood~     sugar. It is administered by injection into the vein and under the skin of the abdomen, thigh~     and arm.~      The study will be conducted in healthy people to investigate the effect of different~     injection sites on the amount of insulin lispro in the bloodstream.~      Side effects and tolerability will be documented. The study will last for about 10 weeks for~     each participant, including screening and follow up. Screening is required within 28 days~     prior to entering the study.~   "
25515|NCT03232970|"~     Comparison between two groups, experimental and control. Experimental will undergo lectures~     on a diet to increase fiber consumption. Blood tests and anthropometric measures will be done~     before and after the 3-months long program. Comparisons will be made pre and post and with~     groups.~   "
25516|NCT03232957|"~     This study evaluates postoperative numerical pain score and systemic opioid requirement~     within 48 hours for unilateral total knee arthroplasty. Comparing among 3 groups of~     intrathecal morphine; 0,50, 100 ug with multimodal analgesia.~   "
25517|NCT03232944|"~     The purpose of this Post-Approval Study (PAS) is to evaluate the effectiveness of MPP to~     improve CRT response in the non-responder patient population when used in real-world~     clinical practice, following commercial release. This evaluation is based on the Clinical~     Composite Score which summarizes the proportions and frequencies of CRT non-responder~     patients who are improved, unchanged or worsened after receiving MPP therapy. Patients~     will be followed for the duration of the PAS. This study is required by FDA as a condition of~     approval of the MPP feature and is integrated within the Product Surveillance Registry (PSR).~   "
25518|NCT03232931|"~     Every year, almost all of ½ million infants born prematurely in the US and 15 million~     worldwide suffer from abnormal brain maturation resulting from interactions between~     immaturity and atypical sensory experiences after birth. The current proposal uses rigorous~     scientific methods to measure the effects and determine the mechanisms of action of a~     parent-supported multisensory neurorehabilitative intervention for preterm infants, adaptable~     to a wide variety of neonatal environments, even when parents cannot be at their child's~     bedside. The intervention aims to improve brain multisensory processing, reactions to sensory~     stimulation in the home and long term language and motor development.~   "
25519|NCT03232918|"~     The reported risk of nonreassuring fetal heart trace following neuraxial analgesia is 3-23%.~     This variability may be due to fluid and oxytocin management prior to and during the~     initiation of neuraxial analgesia. The study hypothesis is that decreasing the oxytocin~     infusion rate by 50 % prior to initiation of combined spinal epidural analgesia will cause a~     reduction in the incidence of adverse fetal heart rate changes.~   "
25520|NCT03232905|"~     This study is a phase 1 study of PF-06651600. PF-06651600 is being developed for treatment of~     inflammatory bowel disease. The goal of the study is to assess the safety, tolerability,~     pharmacokinetics and pharmacodynamics of PF-06651600 after multiple oral doses of PF-06651600~     in Japanese healthy volunteers.~   "
25521|NCT03232892|"~     Phase II trial to evaluate trametinib in patients with locally advanced non-squamous,~     non-small cell lung cancer (NSCLC) whose tumors harbor a non-synonymous NF-1 mutation, with~     progressive disease on at least one prior line of therapy.~   "
25522|NCT03232879|"~     The main objective of this study was to compare the activation of the Sympathetic Nervous~     System in a program that combined Motor Imagery with Action Observation, in contrast to an~     isolated Motor Imagery program on the one hand in asymptomatic subjects and in the other hand~     in patients with chronic low back pain.~   "
25523|NCT03232866|"~     There has been an increasing awareness about the need to practice some physical activity,~     including several objectives, mainly as a preventive character. From this perspective, notice~     the use of the Pilates method as an instrument of therapeutic exercise for the protection and~     promotion of health. However, despite being popularly performed, there is still no scientific~     evidence on the standardization of the use of the method and its progression to an adequate~     prescription of physical training. The objective is monitoring the progression of loads of a~     12-week training among the basic, intermediate and advanced levels of the Pilates method~     through heart rate (HR), subjective exertion perception (PSE) and heart rate variability~     (HRV). In addition, analyzing the effect of the method on cardiorespiratory and autonomic~     parameters. 40 healthy men aged 18-36 will receive Pilates training for 12 weeks. After the~     initial assessment and familiarization with the method, the training period will begin~     totalizing 36 sessions for three months, where each class lasts approximately 1 hour. During~     the three months, the participants must pass through the three levels of training: Basic,~     Intermediate and Advanced. During each session, the investigators will initially collect:~     psychological questionnaire, visual analogue pain scale (VAS), and cardiorespiratory~     parameters (systolic and diastolic blood pressure, HR, respiratory rate and partial oxygen~     saturation). Throughout the session a heart rate meter will be positioned on the chest of the~     participant to capture HR, which will occur every five minutes together with the PSE~     illustrated in the model proposed by Borg. At the end of each session, the cardiorespiratory~     parameters will be collected again. In addition, cardiorespiratory parameters and HRV will be~     analyzed at baseline and after three months of training. In the case of HRV analysis, linear~     methods in the time and frequency domain will be verified. For the statistical analysis of~     the cardiorespiratory and autonomic parameters in the pre and post training moments will be~     used paired t test for normal data or Wilcoxon test for non normal data. For the analysis of~     the training load will be used the correlation of Pearson or Sperman according to normality.~     The definition of cutoff points for the HRV and PSE indices will be obtained by the ROC~     curve.~   "
25524|NCT03232853|"~     The purpose of this observational study is to assess the efficiency of an e-learning in order~     to put into practice some preventive measures to avoid medication errors during anesthesia.~   "
25525|NCT03232840|"~     The purpose of this observational study is to assess the efficiency of an e-learning in order~     to put into practice some preventive measures to avoid wrong site surgery during anesthesia.~   "
25526|NCT03232827|"~     The overall aim of the current study is to determine if flavorings contribute to the~     initiation and maintenance of waterpipe (WP) smoking and also influence how a WP is smoked,~     which has implications for both risk of dependence but also smokers' level of exposure to~     tobacco-related toxicants. Using a randomized crossover-design, 76 current WP smokers (38 low~     dependent, 38 high dependent) will complete three counterbalanced WP smoking sessions~     (preferred flavored-sweetened, unflavored-sweetened, and unflavored-very low sweetened) that~     are preceded by 12 hours of tobacco/nicotine abstinence. Sessions will be separated by a~     standard 48-hour washout period.~   "
25588|NCT03232008|"~     This study investigates the effects of Canderel, an aspartame and acesulfame-k blend~     artificial sweetener powder, on post-postprandial blood glucose levels and appetite scores.~     Participants will be randomly given either the placebo drink (3g of maltodextrin dissolved in~     250ml of water) or the Canderel drink (3g of Canderel dissolved in 250ml of water) alongside~     an isocaloric breakfast. Blood glucose measurements will be obtained through finger pricking~     and appetite will be measured using self-reported visual analog scores rating hunger, desire~     to eat, fullness and alertness for up to 3 hours after breakfast.~   "
25527|NCT03232814|"~     In Canada, over 102,900 men are diagnosed with cancer each year. Of these, 81,000 are~     diagnosed with colorectal cancer and an estimated 65% are expected to survive the disease for~     at least 5 years. Men who have completed treatment for colorectal cancer face many adverse~     physical, cognitive, psychological, and social effects. The Wellness Beyond Cancer Program at~     The Ottawa Hospital is a cancer survivorship program that helps people who have completed~     treatment for cancer, including men diagnosed with colorectal cancer, manage these effects.~     The Wellness Beyond Cancer Program does this through education and referral to supportive~     care services and programs offered throughout the city of Ottawa.~      Group-based physical activity programs are one of the varied services and programs available~     to adults diagnosed with cancer in Ottawa. Such programs are offered through the Ottawa~     Regional Cancer Foundation (http://www.ottawacancer.ca) and Breast Cancer Action Ottawa~     (http://bcaott.ca). Research on these programs show that group-based physical activity can~     improve disease and treatment-related effects while promoting overall quality of life amongst~     women with cancer. However, few of these programs have targeted men, even though their needs~     and preferences have been shown to be very different from women. While men diagnosed with~     colorectal cancer might also benefit from group-based physical activity programs offered in~     the community, it is not known if such programs would effectively reach them and what the~     impact would be on their quality of life after cancer treatment.~      It is believed that a men's group-based walking program could be an effective way to reach~     men and promote quality of life after cancer treatment. Therefore, a sustainable 8-week~     group-based walking program was developed. This project will seek to explore the feasibility~     and potential benefits of the program among men who have completed treatment for colorectal~     cancer and who are referred to the program from staff at the Wellness Beyond Cancer Program~     in a prospective single-arm trial.~   "
25528|NCT03232801|"~     The overall aim of this research is to adapt and pilot test a multi-component,~     mindfulness-based behavioral intervention for women age 50 and older with low sexual desire.~   "
25529|NCT03232788|"~     This study will seek to evaluate the predictability and efficacy of a Computer Aided~     Design-Computer Aided Manufacturing and additively manufactured polycaprolactone and~     hydroxyapatite scaffolds in these defects compared to traditional guided tissue regeneration.~     40 gingival recessions associated with interproximal tissue deficiency will be divided into~     two groups: control group (autogenous bone + collagen membrane; n = 20) and test group~     (autogenous bone + scaffold; n = 20).~   "
25530|NCT03232775|"~     Children with autism spectrum disorders (ASDs) have unique social-communication and behavior~     impairments that complicate their medical management. This study aimed to evaluate the~     effectiveness of using a picture schedule paired with a reinforcement system during the~     medical exam. Two groups (treatment and control) of children (ages 5 - 10 yrs) diagnosed with~     ASD and below average adaptive communication impairment were asked to participate. Following~     participation in an overview of autism diagnostic symptoms training, two teams (comprised of~     one chief medical resident and one nurse), blind to the study aim, conducted the study exams.~   "
25531|NCT03232762|"~     The purpose of the study is to compare 3 different diets in pregnancy, equal in calories, and~     fats, different in refined grains compared to whole grains as a source of carbohydrates, and~     in calories from carbohydrate, compared to protein as a source of calories.The hypothesis is~     that there will be differences in the specified outcomes because the proportions of~     macronutrients are significant. The primary objective is to detect differences in weight~     gain.~   "
25532|NCT03232749|"~     This study will examine the effectiveness of a single cortisone injection in patients with~     shoulder osteoarthritis over a 6-month period, and identify clinical and radiographic factors~     to help predict how a patient with shoulder osteoarthritis will respond to a cortisone~     injection utilizing ultrasound guidance.~   "
25533|NCT03232736|"~     The primary reason the investigators are doing this study are to understand how the right~     side of the heart functions in heart failure patients with left ventricular assist devices~     (LVADs, or mechanical hearts). Second, the investigators are interested in understanding~     how different pacemaker settings influence function of the heart at rest and activity.~   "
25534|NCT03232723|"~     The primary purpose of this study is to determine the effectiveness of the~     Magnetoencephalography (MEG) instrument to record electrical activity from parts of the body~     other than the brain. This study will examine if electrical activity from parts of the body,~     other than the brain, can be imaged by the MEG instrument. Finding will contribute to studies~     of pain, since abnormal electrical activity in skeletal muscle is the basis of pain, which~     can be severe, yet there is no non-invasive way to image this abnormal activity. This is~     particularly relevant to deep muscle pain and back pain.~   "
25535|NCT03232710|"~     To compare the rate and extent of absorption of Aripiprazole Orally disintegrating tablets 10~     mg of Chengdu Kanghong Pharmaceutical Group Co.,Ltd, China and ABILIFY (Aripiprazole) 10 mg~     orodispersible tablets of Otsuka Pharmaceutical Europe Ltd. in healthy, adult, human subjects~     under fasting/fed condition as well as to monitor the safety and tolerability of subjects.~   "
25536|NCT03232697|"~     The aim of the study is to validate a french version of the 5 minutes version of the Montreal~     Cognitive Assessment as compared to the french full version of this test.~   "
25537|NCT03232684|"~     The study is aimed at verifying if a pulmonologist in training can reliably assess the~     adequacy of EBUS-TBNA samples from intrathoracic lymphadenopathy after a period of training~     provided by an experienced pathologist.~   "
25538|NCT03232671|"~     Evaluating the additional value of Macrophage Migration Inhibitory factor (MIF) in~     cardiovascular diseases when assessed in clinical routine.~   "
25539|NCT03232658|"~     Obstructive sleep apnea (OSA) is a common nocturnal breathing disorder characterized by~     complete (apnea) and partial (hypopnea) breathing cessations during sleep. Currently,~     clinical diagnosis of OSA is based on the clinical symptoms, especially excessive daytime~     sleepiness, and apnea-hypopnea index (AHI) providing a limited overview of the breathing~     cessation event frequency during the night. Longer obstruction events and deeper~     desaturations have been suggested to be more harmful than shorter and shallower events and~     these individual characteristics are completely neglected by conventional and currently used~     AHI.~      The investigators have previously introduced novel diagnostic parameters incorporating the~     number, duration and morphology of individual obstruction events and shown that they improve~     the severity estimation of OSA compared to traditional measures. Even though, the novel~     diagnostic parameters have so far tackled some of shortcomings of AHI, they need to be~     refined to further increase the accuracy of the OSA severity estimation.~      It has been shown that age, body mass index (BMI) and sleeping position are strongly related~     to the severity OSA. However, it is not thoroughly studied whether the severity of individual~     obstruction events progress over time (the aging process) and which factors affect to this~     progression. In addition, AHI has poor correlation with excessive daytime sleepiness (EDS)~     albeit both of them are used to estimate the severity of OSA.~      It is known that OSA patients with similar AHI values, durations of individual breathing~     cessation events can differ significantly. Longer and deeper events are connected to~     increased mortality rate in patients with moderate or severe OSA and thus, could be~     considered to be more detrimental than shorter and shallower ones. However, it has not been~     thoroughly investigated whether in severe OSA patients with identical AHI values, sleep~     efficiency or hypertension is related to the severity of individual breathing cessation~     events.~      The investigators planned to explore, whether the individual breathing cessation event~     severity progress over time and how different confounding factors affect this progression.~     Furthermore, the correlation of EDS with the individual breathing cessation event severity,~     sleep structure, and frequency and occurrence of cortical arousals will be investigated.~     Also, the investigators will explore whether the percentage time of disturbed breathing from~     total sleep time is related to sleep efficiency or hypertension in severe OSA patients having~     similar AHI. Moreover, Positional therapy (PT) i.e., the avoidance of the supine posture~     during sleep is the treatment of choice for Positional Patients (PP) having most of their~     breathing abnormalities while sleeping supine. Since it is known that apneas/hypopneas are~     more severe while sleeping supine, this time the investigators will assess the therapeutic~     value of PT for severe Non Positional patients (NPP).~   "
25540|NCT03232645|"~     The objective of the study is to collect data on the use of the Rhythmia HDx mapping system~     running commercially available Software Version 2.0 or any future commercially available~     Software Version with DirectSense technology and the IntellaMap OrionTM mapping catheter in~     patients indicated for ablation treatment for de-novo Paroxysmal Atrial Fibrillation (PAF).~     The study will collect specific information to characterize the DirectSense technology in~     subjects undergoing catheter-based endocardial mapping and ablation for de-novo PAF using a~     commercial Rhythmia HDx mapping system. The clinical local impedance data will be used in~     order to generate usage guidance on the DirectSense local impedance feature in the management~     of de-novo PAF cases requiring Pulmonary Vein Isolation (PVI) and in order to further develop~     a future lesion indexing feature.~   "
25541|NCT03232632|"~     To estimate distribution's parameters of 18F-Flutemetamol (Vizamyl®) fixation on myocardium~     for patients with amyloid cardiac injuries.~   "
25542|NCT03232619|"~     This study aims to evaluate the safety and efficacy of a novel CD19-CART in the treatment of~     refractory or recurrent ALL.~   "
25543|NCT03232606|"~     Physical activity is mandatory to the optimal development and health of children. The~     presence of asthmatic manifestations may influence the comportment of children and its family~     toward exercise and practice of sports. There no scientific argument to advice a reduction of~     physical activity in asthmatic children, but previous studies showed that physical activity~     is reduced in asthmatic children.~      The aim of this observational study is to evaluate the existing factors leading to this~     reduction of physical activity in asthmatic children and their families.~   "
25544|NCT03232593|"~     This Phase 4, prospective, multicenter, non-interventional, regulatory post-marketing~     surveillance study will collect information on the the safety and effectiveness of~     atezolizumab under the clinical practice, and update the drug label approved by the MFDS in~     Korea.~   "
25545|NCT03232580|"~     Twenty evaluable patients with clinical suspicion or confirmed diagnosis of spondyloarthritis~     due to ankylosing spondylitis, or associated with other known clinical conditions like~     inflammatory bowel disease, psoriatic arthritis, or undifferentiated spondyloarthropathy.~      Five patients will be recruited in the first part of the trial, as a Proof of Concept (PoC)~     phase. The PoC phase will assess the imaging potential of 99mTc-rhAnnexin V-128 in terms of~     imaging quality, disease-lesion radiotracer uptake and medical relevance to enable the~     decision-making to terminate or to continue the clinical investigation completing the~     enrollment with the remaining 15 patients.~   "
25546|NCT03232567|"~     This is a Phase 2a, randomized, double-blind, placebo-controlled trial to evaluate the safety~     and immunogenicity of NasoVAX in healthy adults 18 to 49 years of age. Subjects will be~     screened within 28 days of randomization (Day 1).~   "
25547|NCT03232554|"~     This study evaluates Buxue Yimu Pills，Ferrous Sulfate and the addition of Buxue Yimu Pills to~     Ferrous Sulfate in the treatment of Iron-Deficiency Anemia in adults women. One third of~     participanta will receive Buxue Yimu Pills, one third of participanta will receive Buxue Yimu~     Pills, one third of participanta will receive Ferrous Sulfate，and the another third will~     receive Buxue Yimu Pills and Ferrous Sulfate in combination.~   "
25548|NCT03232541|"~     Background: Nausea and vomiting (emesis) is a common and burdensome side-effect of emetogenic~     chemotherapy. Emesis affects both the patient's quality of life and induces high costs within~     the health-care system. Many patients are interested in acupuncture, despite weak scrientific~     evidence for its effects beside non-specific effects. Few credibly sham-controlled studies~     have previously been conducted. The therapist's care and communication during acupuncture as~     well as during standard care may induce non-specific effects, such as placebo effects,~     potentially driven by the patient's expectations. It is not known if the type of~     communication, in terms of how positive the therapist communicates regarding expected~     effects, affects the effect of antiemetic treatments.~      Aims: To investigate if chemotherapy-induced emesis, treatment expectancy and quality of life~     differ between patients who receive A) standard care including antiemetics, B) standard care~     plus sham acupuncture or C) standard treatment plus genuine acupuncture by a therapist who~     emphasizes the positive expected outcomes of the treatment, compared to a therapist who~     communicates neutral regarding the expected outcomes.~      Procedure: The eligible patients will be randomized to A) standard care, including~     antiemetics or to B) standard treatment plus sham acupuncture or C) standard treatment plus~     genuine acupuncture. Within the three groups, the patients are randomized to receive either~     neutral or positive communication with the therapist during the treatment.~      Outcome measures: The primary outcome is intensity of nausea within the five days after the~     chemotherapy session in patients receiving positive or neutral communication. Data collection~     of nausea and vomiting, expectations, and quality of life is performed at baseline the day~     before the studied chemotherapy session, during 10 days after the studied chemotherapy~     session, and at a follow-up ten days after the last chemotherapy session.~   "
25549|NCT03232528|"~     To evaluate the efficacy of Moxibustion in the treatment of Ulcerative Colitis, thus the~     scientific foundation for rational use of Moxibustion in clinical usage, in order to find~     admission of the Acupuncture and Moxibustion and even medicine field, accomplish~     popularization and application.~   "
25550|NCT03232515|"~     INTRODUCTION: Accurate estimation of dry weight (DW) is an important and difficult problem in~     clinical practice. DW is defined as the lowest weight after hemodialysis (HD) where the~     patient will not develop symptoms of hypotension and edema, in addition to not using~     antihypertensives. Achieving a fluid balance benefits the control of blood pressure and~     reduces cardiovascular risk. In most HD centers, the DW is estimated using a subjective~     method dependent on the signs and symptoms that the patient presents. Recently, several~     approaches have been studied to develop a standardized DW evaluation technique. Among these,~     the analysis of electric bioimpedance vectors (BIVA) has been recognized as a simple and~     promising method with high reproducibility.~      OBJECTIVE: To use BIVA to improve dry weight estimation in patients with chronic renal~     failure undergoing hemodialysis.~      Methods: This is a non-randomized pre-test / post-test clinical trial, where the universe of~     patients comes from the hemodialysis unit of the General State Hospital of Sonora.~      Patients who have limb amputations, pacemakers, metal implants, who are under renal~     transplant protocol or who have a renal transplant, and presence of infectious foci will be~     restricted from participating.~      The diagnosis of DW in the patients will be performed for modification and follow-up. Fluid~     status will be evaluated using BIVA. Measurements will be made before and after HD in three~     consecutive weekly periods and one one final assessment at three months.~      At the beginning of each period, weight, electrolytes, creatinine, total proteins, albumin,~     pre-albumin, urea and blood pressure will be measured to calculate the Malnutrition~     Inflammation Score and Bilbrey Index. At the end of the HD protocol of each period, body~     composition and muscle strength will be evaluated through triceps skinfold, mid-upper arm~     circumference and dynamometry. The dialysis dose received will be modified according to BIVA.~      The main variables to be considered will be DW, extracellular water and blood pressure.~      The duration of the study will be approximately 6 months. In addition, at the end of each~     measurement, each participant will be given a nutritional recommendation (feeding guide)~     specific to their energy requirements.~   "
25551|NCT03232502|"~     Pragmatic trial of pharmacogenetic testing at the time of prescription for a selective~     serotonin reuptake inhibitor, tricyclic antidepressant or atypical antipsychotic. Does real~     time intervention improve patient outcomes?~   "
25640|NCT03231332|"~     The aim of this Project is, within the scope of industrial research, to evaluate the long~     term effects of H.pylori eradication on microbiome (gut microbiome, upper respiratory tract~     microbiome) and lasting adverse events. In addition, the project aims to evaluate its effects~     on abundance and prevalence of extended-spectrum beta-lactamases coding genes and develop~     cost effective ESBL screening test prototype.~   "
25552|NCT03232489|"~     The purpose of this research study is to evaluate the feasibility in conducting advanced MRI~     sequences in a pediatric clinical setting. The study will be observational in nature, and~     will only evaluate the studies of pediatric patients who have already been prescribed an~     advanced MRI for clinical neurological purposes. The only difference for the subject in~     participating in this study is that the data and information about their scan can be used and~     disclosed for research purposes, i.e. understanding if the time of the scan, patient comfort,~     and quality of the data are feasible. Standard MRI's have been extremely beneficial in the~     diagnosis and assessment of disease, injury, and anomalies throughout the body. Adding~     advanced MRI sequences to the arsenal of current standard MRI sequences, as well as analyzing~     the clinical significance of the data, may improve the benefits of MRI in the future. Within~     this scope, the study will be looking at the following factors:~        1. The total time of the scan, including:~             -  Patient arrival time/lateness~             -  Patient preparation time~             -  Time scanner is being occupied~             -  Patient compliance (is the patient continually stopping the study for breaks, fear,~               movement, etc.)~        2. Patient dropout rate, including:~             -  Change of mind~             -  Cost of study is too much~             -  Failure to finish the scan~        3. Usability of data, including:~             -  Movement artifact~             -  Patient requiring re-scan for any reason~      The scan will consist of two to five advanced MRI sequences that will average between 7-15~     minutes each, in addition to a routine 5 minute standard MRI sequence. The variability in the~     number of advanced sequences depends on the prescription and patient history. All sequences~     are performed using a 1.5 Tesla Siemens MRI scanner at Westwood Open MRI, a 3 Tesla GE~     scanner at Tower Saint John's Imaging, or a 3 Tesla Siemens MRI scanner at Resolution~     Imaging. All scanners are FDA-approved.~   "
25553|NCT03232476|"~     Clinical trial to investigate effect of voluntary upper extremity loading in combination with~     anabolic osteoporosis therapy.~   "
25554|NCT03232463|"~     The purpose of this research study is to evaluate the feasibility in conducting advanced MRI~     sequences in a clinical setting. The study will be observational in nature, and will only~     evaluate the studies of patients that have already been prescribed an advanced MRI for~     clinical neurological purposes. The only difference for the subject in participating in this~     study is that the data and information about their scan can be used and disclosed for~     research purposes, which is understanding if the time of the scan, patient comfort, and~     quality of the data are feasible. Standard MRI's have been extremely beneficial in the~     diagnosis and assessment of disease, injury, and anomalies throughout the body. Adding~     advanced MRI sequences to the arsenal of current standard MRI sequences, as well as analyzing~     the clinical significance of the data, may improve the benefits of MRI in the future. Within~     this scope, the study will be looking at the following factors:~        1. The total time of the scan, including:~             -  Patient arrival time/lateness~             -  Patient preparation time~             -  Time scanner is being occupied~             -  Patient compliance (is the patient continually stopping the study for breaks, fear,~               movement, etc)~        2. Patient dropout rate, including:~             -  Change of mind~             -  Cost of study is too much~             -  Failure to finish the scan~        3. Usability of data, including:~             -  Movement artifact~             -  Patient requiring re-scan for any reason~      The scan will consist of several advanced MRI sequences that will average between 7-15~     minutes each, in addition to a routine 5 minute standard MRI sequence. The variability in the~     number of advanced sequences depends on the prescription and patient history. All sequences~     are performed using an FDA-approved MRI scanner.~   "
25555|NCT03232450|"~     Participants enrolled in this study will have been diagnosed with patent foramen ovale (PFO)~     and have been scheduled to have a cardiovascular implantable electronic device (CIED) such as~     a pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization~     therapy (CRT) device implanted. A PFO is a condition when there is a hole in the septum (the~     wall separating the right and left sides) of the heart.~      The purpose of this study is to determine whether closing the PFO with the GORE® Cardioform~     Septal Occluder in people with an endocardial device leads reduces the risk of recurrent~     stroke or imaging-confirmed transient ischemic attack (TIA) compared to not closing the PFO.~   "
25556|NCT03232437|"~     A three site study to evaluate the reproducibility of the Aina HbA1c Monitoring System in~     quantitative determination of glycosylated hemoglobin (HbA1c) took place at the following~     sites:~        1. Forsyth Institute in Cambridge, MA~        2. Orange County Research Center in Tustin, CA~        3. ActivMed Practices & Research in Methuen, MA~   "
25557|NCT03232424|"~     This study is a prospective single arm trial designed to study the safety, feasibility and~     preliminary efficacy of a medical device, NovoTTF-200A used concomitantly with standard~     adjuvant treatment for newly diagnosed glioblastoma.~   "
25558|NCT03232411|"~     The purposes of this study are: a) to develop a statewide Biobank for prostate cancer among~     men of African Ancestry in Florida and; b) to examine whether smoking increases the~     aggressiveness of prostate cancer using several biological approaches.~      Investigators plan to contact African American prostate cancer patients regarding~     participation. This project has 3 main components. Eligible patients may choose to~     participate in any or all parts of the study: Questionnaires; Saliva Samples; Tumor Tissue.~   "
25559|NCT03232398|"~     Patients with acute ST-segment elevation myocardial infarction (STEMI) have an elevated risk~     of stroke, most of which are cardio-embolic in origin as a result of left ventricular (LV)~     thrombus formation. Anterior-wall location of a MI, in particular, can lead to the~     complications of LV aneurysm and/or thrombus, which some estimate occurs in approximately up~     to one-third of individuals within the first 2 weeks following an anterior MI.~      In the absence of anti coagulation, the risk of embolization in patients with a documented LV~     thrombus has been reported to be between 10 and 15 percent [3]. Although there are no~     randomized trials evaluating the efficacy of anticoagulation in patients with an LV thrombus~     after MI, observational studies provide substantial supporting evidence for the~     recommendation to anticoagulate patients with documented LV thrombus in order to reduce the~     risk of embolization. The observation that most events occur within the first three months~     from the MI forms the basis for the recommendation that anticoagulant therapy should be~     started early and continued for at least three to six months after myocardial infarction.~     Currently the practice guidelines recommend anticoagulation after MI only in certain settings~     such as the presence of LV thrombus or atrial fibrillation. To date there are no data on the~     use of novel oral anticoagulants (NOACS) for stroke prevention in the setting of LV thrombus~     after acute MI.~      The proposed aim of this randomized open label non inferiority clinical trial is to assess~     whether apixaban is as effective as VKA for the treatment of LV thrombus after acute ST~     segment elevation MI.~      Population: Patients with evidence of LV thrombus as assessed by trans-thoracic~     echocardiography (TTE) 3 to 7 days post admission for acute ST-elevation MI~      Intervention: The patients will be randomly assigned to treatment with apixaban or s.c~     enoxaparin 1mg/Kg BID followed by dose-adjusted warfarin to achieve a target international~     normalized ratio (INR) of 2.0 to 3.0 for 3 months.~      The study Outcomes are the presence of LV thrombus as assessed be echo, major bleeding, and~     stroke or systemic embolism and death from any cause.~   "
25560|NCT03232385|"~     The objective of this research is to evaluate functional validation of the MR-US fusion for~     the Clear Guide SCENERGY system, as well as to evaluate benefits derived from system~     performance.~   "
25574|NCT03232203|"~     STRIMVELIS is a medicinal product developed by GSK that restores adenosine deaminase (ADA)~     function in hematopoietic cell lineages, thereby preventing impaired immune function.~     STRIMVELIS is indicated for the treatment of patients with ADA- severe combined~     immunodeficiency (SCID), for whom suitable human leukocyte antigen (HLA)-matched related stem~     cell donor is not available. The objective of this study is to evaluate the effectiveness of~     routine and additional risk minimization measures by assessing the understanding of referring~     health care providers (HCPs) and parents/carers (hereby referred as participants) with regard~     to the specific risks associated with STRIMVELIS. In this cross-sectional study, surveys will~     be provided to referring HCPs and parents/carers of children approximately six months after~     treatment with STRIMVELIS. The study will recruit for approximately two years until 10~     referring HCPs and 10 parents/carers have completed their respective surveys. STRIMVELIS is a~     trade mark of the GSK group of companies.~   "
25561|NCT03232372|"~     When an implant is placed, it is assumed that there will be a loss of bone in the more~     coronal area around it. The placement of the implant in relation to bone level, either~     crestal or subcrestal and the type of connection chosen, either external connection or~     internal connection, have been related as one of the factors that caused this loss. The~     preservation of the peri-implant bone influences the shape and contour of the underlying soft~     tissues, which are important for the aesthetic result of the treatment and for the success of~     the same.~      Hypothesis: The hypothesis is that there are no differences between the external and internal~     connection with regard to marginal bone loss. In implants placed at the crestal and~     subcrestal level, the hypothesis is that there is greater marginal bone loss in implants~     placed at the subcrestal level.~      Objectives: Main: To evaluate the marginal bone loss around implants of internal connection~     and external connection. Secondary: To compare the loss of bone in implants of internal~     connection placed at crestal and subcrestal level. To evaluate intra and post-operative~     complications.~      Material and methods: A prospective and randomized radiological study will be performed. 150~     implants will be placed in patients who must present partial edentulism and require the~     replacement of at least 2 crowns on implants in the same jaw. In a randomized manner,~     implants of external connection and internal connection will be placed. Other features such~     as surface treatment type of the implant will be similar in both types of implants to reduce~     bias.~      With this study the investigators will try to define if there is a procedure in when to the~     connection of the implant and the location of this, that is more beneficial with respect to~     the preservation of bone.~   "
25562|NCT03232359|"~     Immature platelet fraction is a non-invasive test of real time thrombopoiesis. High IPF% has~     been suggested as an indicator of thrombocytopenia due to rapid platelet consumption. IPF% is~     able to discriminate between patients with TTP/HUS or SPE/HELLP~   "
25563|NCT03232346|"~     This study is an open--label randomized outpatient trial to evaluate feasibility and efficacy~     of rapid buprenorphine (BUP) discontinuation followed by brief course of treatment with~     long--acting naltrexone (XR--NTX) and to compare it to the standard method of gradual BUP~     taper.Individuals with opioid use disorder (OUD) (N=60) who have successfully completed at~     least 6 months of buprenorphine treatment and do not wish to remain in a long--term~     buprenorphine maintenance program will be recruited. The first phase includes a 4--week~     period of stabilization on buprenorphine 4--8 mg at the research clinic to assure that~     patients are stable, compliant, and free from illicit opioids. Participants that meet the~     above criteria will be randomized 1:1 to: 1) buprenorphine discontinuation and outpatient~     transition to XR--NTX with 3 monthly injections, or 2) buprenorphine discontinuation using a~     gradual 5-week long taper. In both groups participants will receive weekly relapse prevention~     therapy and will be monitored for the duration of the trial, which is 25 weeks post~     randomization.~   "
25564|NCT03232333|"~     This study will assess the ability of MIRODERM to heal difficult diabetic foot ulcers within~     12 weeks of treatment.~   "
25565|NCT03232320|"~     To determine the efficacy and safety of Meditoxin in subjects with cervical dystonia compared~     with placebo (normal saline)~   "
25566|NCT03232307|"~     The goal of this clinical research study is to learn if a combination of ibrutinib,~     rituximab, and lenalidomide can help control newly diagnosed mantle cell lymphoma (MCL) in~     patients over 65. The safety of this drug combination will also be studied.~   "
25567|NCT03232294|"~     Abnormal fetal development such as macrosomia can cause some complications on both fetus and~     mother.The measurement of fetal anterior abdominal wall thickness (FAWT) is an easy~     examination that it can be obtained during an examination of a pregnant woman by ultrasound.~     Macrosomia for fetus can lead to some morbidities. It can affect perinatal outcome and~     increase childbirth complications and operative birth. There are some studies scrutinizing~     the relationship between FAWT and diabetes in the literature. However there are few studies~     which scrutinize effect of FAWT on both abnormal fetal development and adverse perinatal~     outcomes in non-diabetic pregnancies and non high risk pregnancies. Hence the investigators~     wonder if FAWT can anticipate birth-weight or macrosomic infant or perinatal outcome~     regarding with macrosomia in the second trimester.~   "
25568|NCT03232281|"~     To assess the efficacy of triptorelin pamoate prolonged release (PR) 3-month formulation in~     Chinese female subjects with endometriosis by demonstrating the non-inferiority of~     triptorelin pamoate PR 3-month formulation injected once as compared to triptorelin acetate~     PR 1-month formulation injected 3 times consecutively.~   "
25569|NCT03232268|"~     This study aims at evaluating the safety of an approach based on HLA-mismatched~     Microtransplantation without immunosuppressive treatment in patients With myeloid hemopathies~     who are ineligible to conventional allograft~   "
25570|NCT03232255|"~     This study is to evaluate the benefit and tolerability of a Mouthrinse (IQP-OLP-101) in the~     treatment of dentine hypersensitivity.~   "
25571|NCT03232242|"~     Infectious disease leads to deaths that accounted for more than 25% of all causes of human~     mortality. But the traditional microbiological diagnostic methods such as specimen culture~     are sometimes time-consuming, and have limited sensitivity. And some bacteria, anaerobes and~     viruses may be difficult to cultivate and isolation. Therefore, the accurate identification~     and rapid classification of pathogenic microorganisms is very important for the patient's~     precise diagnosis and timely treatment.~      Small-scale studies on the diagnostic efficacy and prognosis of infection in the next~     generation have been shown to provide early diagnosis and targeted medication guidance for~     bloodstream infections and respiratory infections, but the larger-scale validation of~     next-generation sequencing Technology in the diagnosis and treatment of infectious diseases~     in the human body is relatively rare.~      The purpose of this study is to provide rapid etiological diagnosis of patients by means of~     next-generation sequencing, to change the way of treatment of patients under the existing~     traditional pathogen detection by means of accurate description of pathogens and monitoring~     their dynamic changes, and to provide patients with more accurate treatment.~   "
25572|NCT03232229|"~     The aim of this observational study is to examine supplementation (e.g. caffeine or creatin)~     use in both male and female professional tennis players.~   "
25573|NCT03232216|"~     This study evaluates the effect of Vitamin D3 supplementation in healing rate of tibia~     fractures in adult patients with low vitamin D. Half of participants will receive Vitamin D3~     supplementation while the other will receive placebo.~   "
25575|NCT03232190|"~     The main purpose of the neonatal intensive care unit (NICU) is to optimize the development of~     the newborn. Preterm children are at greater risk for developmental disorders. On the one~     hand, this is due to cerebral complications inherent to the prematurity, on the other hand it~     is related to the very early and therefore vulnerable stage of brain development at the time~     of the premature birth. The development of the child is also the result of a constant~     interaction between the infant and its environment, primarily the primary caregiver (i.e. the~     parents). A premature birth can cause great stress to parents, and there are several~     obstacles that can make it difficult to handle their child. Therefore, we have developed a~     web application that supports parents until their child reaches the age of two. By keeping~     them informed, we hope to make them more confident in their role as parents, and thus~     facilitate the parent-child interaction. In order to determine whether this form of support~     has an additional effect on the development of the premature child, we compare two groups of~     premature infants and a group of non-premature infants.~   "
25576|NCT03232177|"~     This study is to evaluate the efficacy and safety according to incremental dosing for 8 weeks~     and duration of administration for 1 year in patients with high-risk essential~     thrombocythemia.~   "
25577|NCT03232164|"~     The overall goal of this research is to validate and develop a non-invasive imaging biomarker~     of prostate cancer detection, progression, and recurrence. Development of such a biomarker~     may be useful to differentiate indolent from aggressive prostate cancer phenotypes allowing~     for selection of an appropriate risk adaptive therapy.~   "
25578|NCT03232151|"~     The overarching objective of our proposal is to develop a One-Stop-Shop imaging using the~     available C-arm Cone-Beam Computed Tomography (CBCT) data acquisition systems currently~     widely available worldwide in interventional angiography suites to enable acute ischemic~     stroke patients to be imaged, triaged, treated, and assessed using a single modality in one~     room.~   "
25579|NCT03232138|"~     This research study involves taking an experimental anti-cancer dietary supplement called~     Sulforaphane (SF) or a placebo (product without any supplement content) over a period of~     twelve months in order to determine if it is a useful dietary supplement for prevention of~     lung cancer in humans.~      The main goals of this research study are:~        1. To learn about the effects of giving Sulforaphane (SF) to former smokers who are still~          at high risk of developing cancer due to their smoking history and whether or not their~          condition improves, stays the same or becomes worse after Sulforaphane (SF) is given.~        2. To learn whether Sulforaphane (SF) might reverse some of the lung cell changes~          associated with future development of lung cancer.~   "
25580|NCT03232125|"~     Intraperitoneal insufflation of carbon dioxide may affect the sympathetic activity that leads~     to changes in ventricular re-polarization. This in turn can result in changes of heart~     rate-corrected QT (QTc) interval. Ramosetron is a 5-hydroxytryptamine three receptor~     antagonist and widely used anti-emetics. However, QTc interval prolongation has been observed~     in a number of patients after administration of 5-HT3 receptor antagonists. The aim of this~     study is to evaluate the effects of ramosetron on QTc interval and possible cardiovascular~     adverse effects during robot-assisted laparoscopic prostatectomy with steep Trendelenburg~     position.~   "
25581|NCT03232112|"~     The study is a double-blinded, randomized, placebo-controlled, 26-weeks clinical trial. The~     objective of the trial is to investigate the effects of the GLP-1 receptor agonist Bydureon®~     (exenatide) vs. placebo on alcohol intake in patients with a diagnosis of alcohol dependence.~   "
25582|NCT03232099|"~     Recent evidence indicates that Trimethylamine-N-oxide (TMAO) is a pro-atherosclerotic,~     phosphatidylcholine-dependent metabolite of diet and intestinal flora. Food substrates derive~     from carnitine and phosphatidylcholine (lecithin), present mainly in eggs, red meat, liver~     and pork. The intestinal flora pattern that favors the formation of TMAO is very similar to~     that which predisposes to insulin resistance and obesity: a high proportion between phylum~     Firmicutes over Bacteroidetes. The intestinal microbiota is sensitive and variable; the use~     of prebiotics and probiotics can change the relationship between Firmicutes/Bacteroidetes~     phyla. Red wine (RW), for its composition with polyphenols and possible bactericidal role,~     may play a role in the intestinal flora modification and could promote proliferation of~     beneficial bacteria. However, the influence of RW on TMAO is not known. This is the~     hypothesis to be tested in this trial. METHODS: This is a prospective, crossover, randomized,~     controlled trial with patients from Heart Institute (InCor), FMUSP and volunteers recruited~     through press releases. We will evaluate 42 patients, all men, with established~     atherosclerotic disease. Patients will be evaluated in a crossed manner: each subject~     receives both treatments, intervention and control (in random order), and they will be~     divided into 2 groups: A and B. In the first intervention stage, after 2 weeks of washout for~     all patients , group A receives Red Wine (RW) and group B is the control, abstemious. In the~     2nd stage of intervention, after 2 weeks of washout for all patients the groups are inverted:~     group B receives RW; and group A will be abstemious. In the period with wine intervention,~     patients will receive 250 mL/day of red wine per day, for 5 days of the week, for 3 weeks.~     Patients will maintain their usual diet without the use of prebiotics or probiotics, or other~     polyphenolic derivatives. At the beginning and at the end of each stage, patients will be~     submitted to serum TMAO and intestinal microbiota evaluation. For the intestinal microbiota~     evaluation, the new generation sequencing will be used in the highly preserved portion of the~     16S subunit of the rRNA gene. The determination of TMAO in plasma will be by liquid~     chromatography coupled to mass spectrometry. Expected results: It is expected to determine if~     RW acts on the intestinal flora to the point of influencing plasma TMAO concentration.~   "
25583|NCT03232086|"~     Purpose: To determine whether exposure to levels of fine particles that are close to the~     current standard will cause cardiovascular changes in healthy individuals.~   "
25584|NCT03232073|"~     The study AC-058B301 (OPTIMUM; NCT02425644) has been designed to investigate the efficacy,~     safety and tolerability of ponesimod in subjects with relapsing multiple sclerosis (RMS). The~     AC-058B303 study is the long-term extension for the core study AC-058B301. The purpose of~     this long term extension of the core study AC-058B301 is to characterize the long-term~     safety, tolerability, and control of disease of ponesimod 20 mg in subjects with RMS.~   "
25585|NCT03232047|"~     The objective of the study is to evaluate if working memory training is effective in~     improving working memory of MCI patients. Further, to evaluate if cognitive training relates~     to the function and structure of the brain.~   "
25586|NCT03232034|"~     Gut hormones have therapeutic potential in the prevention and treatment obesity and type 2~     diabetes (T2D). Milk protein and calcium can each potentiate gut hormones following meal~     ingestion in humans. However, these nutrients may interact synergistically (and with other~     minerals in milk) such that specific co-ingestion of these nutrients is required to obtain~     the full therapeutic potential for metabolism and energy balance. This proposal is to perform~     a pilot study on the effect of co-ingesting Capolac® plus protein on circulating gut hormone~     responses.~   "
25587|NCT03232021|"~     The aim of this study is to assess the effect of pregabalin administration on~     catheter-related bladder discomfort (CRBD). The study group includes patients that are about~     to be subjected to orthopedic operations.~   "
25589|NCT03231995|"~     Context: Seasonal influenza affects 2.5 to 3 million people each year in France, resulting in~     1500 to 2000 severe cases seen in intensive care units. The severity of influenza is related~     to, among other things, its respiratory or neurological complications, observed especially in~     children. Early determination of the severity of influenza is a critical step to avoid in~     appropriate treatment and care for patients and to improve their survival. Viral, human but~     also environmental factors have been described as having an important role in determining~     this severity. Several studies suggest that the nasopharyngeal microbiome may be involved in~     the incidence and severity of respiratory viral infections. During influenza infection, the~     respiratory microbiota is significantly altered. In animal models, particularly murine~     models, the microbiota regulates the immune response to influenza virus infection. In a~     retrospective preliminary study, the investigators showed that the composition of the~     nasopharyngeal bacterial microbiota is different between children who develop a severe or~     moderate influenza. This difference was observed on respiratory specimens at admission to~     pediatric emergencies within two days of onset of symptoms.~      Hypotheses :~        -  The respiratory microbiome is a determining factor in the clinical course of influenza~          infection (benign vs. severe with respiratory or neurological complication)~        -  The respiratory microbiome can be used as a prognostic biomarker of the clinical course~          of influenza Originality: There are currently no clinical and / or virological markers~          to predict the clinical course of influenza infection. This study will define biomarkers~          of the respiratory microbiome to discriminate patients who will develop a severe~          influenza from those who will develop a moderate influenza. These prognostic biomarkers~          could be used to rapidly refer patients at risk to intensive care units, thus improving~          patient management and care. Moreover, at the fundamental level, this study will specify~          the role of the microbiome in the severity of influenza infection.~   "
25590|NCT03231982|"~     To evaluate the efficacy and safety of amlodipine besylate and candesartan cilexetil~     administered in a fixed-dose combination tablet versus co-administered as their separate~     formulations in patients with essential hypertension who have shown inadequate response on~     monotherapy of amlodipine or candesartan cilexetil or who are with blood pressure adequately~     controlled by co-administration of amlodipine besylate and candesartan cilexetil single~     agents~   "
25591|NCT03231969|"~     To evaluate the efficacy of Bilastine Ophthalmic Solution (0.2%,0.4%,0.6%) compared to~     vehicle for the treatment of the signs and symptoms of allergic conjunctivitis~   "
25592|NCT03231956|"~     To investigate the relationship between initial ClearSight™ derived hemodynamic parameters~     and outcomes (death, ongoing organ dysfunction or delayed ICU admission) in patients with~     acute infection and possible sepsis, with a focus on venous blood lactate (< 2.0, 2.0-3.9,~     and ≥ 4.0 mmol/dL) and hemodynamic subgroups, using ED patients presenting with minor~     infections or asthma/COPD exacerbations as controls (henceforth referred to as Sepsis Mimic~     Group).~   "
25593|NCT03231943|"~     Human immuno deficiency virus 1 (HIV-1) infections continues to be a serious health threat~     throughout the world and development of medicines with new mechanism of action have an~     important role to play. GSK3640254 is a maturation inhibitor (MI) and can be effective in~     HIV-1 treatment. This randomized, 2-part, single and repeat increasing dose study will~     collect information on safety, tolerability and drug levels in the body of in healthy~     subjects for GSK3640254. The information collected in this study will help in further~     clinical development of GSK3640254, including a Phase IIA Proof of Concept (PoC) study in~     HIV-infected subjects. Approximately 16 healthy subjects will be randomized to receive single~     oral dose of GSK3640254 and placebo in Part 1 and approximately 56 healthy subjects will be~     randomized to receive repeat oral dose of GSK3640254 or placebo in Part 2. All doses will be~     given immediately after a moderate fat meal. Maximum duration of study participation will be~     approximately 12 weeks.~   "
25594|NCT03231930|"~     The Rapid-EC pilot study will determine feasibility of providing rapid point-of-care (POC)~     testing for HCV in community clinics, and whether the availability of POC testing increases~     uptake of testing, engagement in care and completion of treatment among people who inject~     drugs.~      The POC tests being utilised in this study are the OraQuick mouth swab test for the presence~     of HCV antibodies, and the Xpert HCV RNA viral load test using serum.~   "
25595|NCT03231917|"~     We plan to conduct a randomized trial of tandem colonoscopies comparing water infusion and~     air insufflation for inspection of mucosa on withdrawal. In one randomized group, water~     infusion will be employed as the first method for mucosal inspection while in a second group,~     CO2 insufflation will be used first. This study will be different than usual care since the~     participants will receive two successive or tandem colonoscopies versus one~   "
25596|NCT03231904|"~     In 2010, Simamura et al have demonstrated in a rat model that one of the pro-inflammatory~     cytokine belonging to the Interleukin-6 family cytokines, LIF, is required for the~     proliferation of neuronal progenitor cells in the cerebrum. They have shown that maternal LIF~     induces ACTH from the placenta, which in turn stimulates fetal nucleated red blood cells to~     secrete LIF, leading finally to neurogenesis in the fetus As demonstrated recently in a mouse~     model, maternal inflammation suppress the physiological maternal— fetal LIF—ACTH—LIF signal,~     result in reduction of ACTH production from placenta, which lead to a reduction in LIF~     concentration in fetal Cerebrospinal fluid (CSF) and impaired proliferation of the neural~     stem/ progenitor cells and poor development of the fetal brain.~      In the current study, the investigators will take fetal and maternal blood samples of fetuses~     undergoing termination of pregnancy (TOP) . Maternal samples will be acquired with the~     routine blood samples before performance of TOP , fetal blood samples will be acquired from~     the umbilical vessel after the termination has been completed , the blood samples will be~     analyzed for levels of LIF and ACTH and checked according to termination pregnancy week,~     Patients electronic files will be checked for relevant demographic and obstetric information.~   "
25610|NCT03231722|"~     -  The association of FOLFOX (5-fluoruracil, folinic acid, and oxaliplatin) and pan is a~          standard option for the first-line treatment of unresectable RAS and BRAF wt mCRC~          patients.~        -  The phase III TRIBE trial recently demonstrated that FOLFOXIRI (5-fluoruracil, folinic~          acid, oxaliplatin and irinotecan) plus bev significantly prolongs PFS and OS and~          increases RECIST response rate, ETS and DoR, as compared to FOLFIRI (5-fluoruracil~          folinic acid, and irinotecan) plus bev. The advantage provided by the intensification of~          the upfront chemotherapy backbone is independent of RAS and BRAF mutational status.~        -  Some phase II trials recently assessed the safety and activity of the combination of~          three-drugs chemotherapy regimens with an anti-EGFR monoclonal antibody. Promising~          activity results in terms of RECIST response rate and R0 resection rate have been~          achieved, with some safety concerns with special regards to gastrointestinal toxicity.~        -  In the phase II randomized MACBETH study the combination of a modified schedule of~          FOLFOXIRI with cetuximab determined remarkable activity results, with an acceptable and~          manageable safety profile.~        -  The optimal duration of the upfront treatment with chemotherapy plus anti-EGFRs is not~          established. The phase II MACRO-2 trial suggested that interrupting FOLFOX after 4~          months while continuing cet alone as maintenance, is a reasonable option.~        -  Activity parameters (RECIST response rate, ETS, DoR) are clinically relevant endpoints,~          associated with longer survival, in particular with anti-EGFR moAb-based treatment.~      On the basis of these considerations, we designed the present phase III randomized trial of~     first-line mFOLFOXIRI plus pan versus mFOLFOX6 plus pan in RAS and BRAF wt unresectable mCRC~     patients.~   "
25611|NCT03231709|"~     The purpose of this study is to examine the patient preference for treatment with once-weekly~     dosing of DPP-4 inhibitor trelagliptin versus once-daily dosing of DPP-4 inhibitor alogliptin~     among the participants with type 2 diabetes mellitus who are being treated with once-daily~     dosing of DPP-4 inhibitor.~   "
25597|NCT03231891|"~     The purpose of the Inherited CAncer REgistry (ICARE) Initiative is to provide individuals~     interested in participating in studies focused on inherited cancer predisposition the~     opportunity to enroll in a research registry. Efforts through the registry include, but are~     not limited to, contribution of data to observational studies, targeted gene-specific~     studies, and education and outreach efforts for both participants and recruiting healthcare~     providers. Participants are given the opportunity to learn about and participate in other~     efforts for which they may be eligible.~      All participants and recruiting healthcare providers receive educational newsletters twice~     per year which contain research and clinical updates in the field of cancer genetics.~     Providers who recruit patients can also access monthly web-based genetics case conferences~     which focus on different topics each month and are generally attended by a guest expert who~     provides background information on the topic as well as comments on the case presentations.~      Participation in ICARE involves completion of an informed consent form, baseline~     questionnaire, follow-up questionnaires every two years, and medical record/tumor releases,~     as applicable. There is no cost to participate and all correspondence can be facilitated~     through phone, email, or mail.~      Enrollment can be completed either through a traditional paper-based consenting method (i.e.~     postal mail) or through the online enrollment option available on the ICARE website~     (InheritedCancer.net). If you are a patient interested in learning more or a provider~     interested in recruiting to ICARE, please visit our website where you may complete an online~     contact form requesting a study team member contact you.~   "
25598|NCT03231878|"~     This is a Phase II/III, randomized, double-blind, placebo-controlled, multicenter, two~     parallel-group study in male patients with the AMN phenotype of X-linked adrenoleukodystrophy~     (X-ALD) to assess the efficacy and safety of MIN-102 treatment. Study sites will consist of~     specialist referral centers experienced in the management of adrenoleukodystrophy (ALD).~   "
25599|NCT03231865|"~     ZnPP is being build in the case of a functional iron deficiency. Zinc instead of iron is~     implemented into protoporphyrin IX. This ZincProtoporphyrin (ZnPP) can be detected non~     invasively. Non invasive and invasive optical measurement of ZnPP will be compared.~     Additionally ZnPP measurements will be compared to other iron deficiency parameters for~     validation by the investigators.~   "
25600|NCT03231852|"~     The objective of our study is to determine which factors affect willingness to participate in~     gynecologic oncology clinical trials. Women with a diagnosis of gynecologic malignancy will~     be approached to complete a survey assessing willingness to participate in clinical trials.~     The validated Attitudes and Randomized Trials Questionnaire (ARTQ) will be used to assess~     willingness to participate.~   "
25601|NCT03231839|"~     This study investigates the influence of red meat and fibers on glucose metabolism and body~     fat composition in subjects at increased risk for type 2 diabetes.~   "
25602|NCT03231826|"~     Patients are screened for significant arrhythmias and other possibly significant ECG-patterns~     directly after discharge and two weeks after myocardial infarction using wearable devices.~     The home monitoring data will be linked with extensive data from electronic health records~     collected before, during hospital stay and after discharge.~      The purpose of the study is to clarify whether home monitoring of continuous ECG-signals can~     be used to predict and prevent serious adverse events after myocardial infarction.~   "
25603|NCT03231813|"~     Irritant contact dermatitis induced by sodium lauryl sulphate (SLS) is often used as a model~     for testing efficacy of various topical preparations. Aforementioned model is standardized~     and described in guidelines, but it is not explicitly stated where the irritation should be~     induced. Published clinical trials usually irritate volar aspect of forearms or upper back.~     Also, lower back and dorsal aspect of forearm are sometimes used.~      Skin parameters vary depending on anatomic location of measured skin. There is a difference~     in stratum corneum thickness, hydration and transepidermal water loss across different~     locations, including between volar forearm and upper back.~      Furthermore, regional difference in skin response to irritation by tape stripping and~     benzalkonium chloride were observed. Such differences are also possible in SLS irritation~     model. One study has shown higher, but not statistically significant, response of back in~     comparison to forearms, but it had a very small sample size (n=9).~      Moreover, there are regional variations of topical preparations absorption. Hydrocortisone~     had 1,7 times higher absorption when applied to upper back in comparison to forearms. Those~     variations could be explained by different corneocyte size and number of their layers between~     back and hands.~      Skin baseline properties and response to irritation seem to be dependent on anatomic~     position. Those differences could mean different response to treatment. Since published~     trials only tested efficacy of various preparations on one anatomic location, it is possible~     their results would be different if tested on other body parts. It could limit validity and~     usefulness of conducted trials. The aim of this study is to determine if there are regional~     differences of skin response to irritation and emollient cream treatment in irritant contact~     dermatitis model.~   "
25604|NCT03231800|"~     A study to evaluate the efficacy and safety of dasotraline in children 6 to 12 years of age~     with Attention-Deficit Hyperactivity Disorder (ADHD) in a simulated classroom setting.~   "
25605|NCT03231787|"~     National, randomized, open, parallel, multicenter clinical trial of two comparison groups~     that will evaluate the feasibility of a strategy based on a diagnostic test to shorten the~     surgery time in antiaggregated patients with proximal femur fracture.~      The experimental group will undergo surgery as soon as platelet aggregability, according to~     the PLATELETWORKS® method is correct within 24-48 hours.~      The control group will undergo surgery according to the usual practice of the center taking~     into account the safety time of the antiplatelet agent.~   "
25606|NCT03231774|"~     This study is to compare transthoracic Echocardiography TTE to the gold standard Right Heart~     Catheterization in Terms of accuracy to measure hemodynamic parameters.~   "
25607|NCT03231761|"~     This is a randomized controlled trial examining the impact of videos on medical students'~     implicit and explicit attitudes and knowledge related to mental illness in Nepal. Medical~     students are randomized to one of three conditions: (a) no video, (b) a didactic video based~     on the mental health Gap Action Programme (mhGAP) modules for depression and psychosis; and~     (c) videos with personal testimonials from mental health service users with depression and~     psychosis.~   "
25608|NCT03231748|"~     This study will be conducted in patients with sepsis and acute kidney injury needing renal~     replacement therapy.~      The aim is to investigate whether continuous renal replacement therapy with the EMIC®2 filter~     leads to removal of pro-inflammatory middle molecular weight cytokines from the blood.~   "
25609|NCT03231735|"~     The purpose of this study is to determine, in preterm infants less than 37 weeks gestation~     with respiratory distress who are ventilated in the first 48 hours after birth, if mid~     frequency ventilation strategy using ventilator rate of ≥ 60 to ≤ 150 per minute compared~     with standard frequency ventilation strategy using ventilator rates of ≥ 20 to < 60 per~     minute will increase the number of alive ventilator-free days after randomization and reduce~     the risk of ventilator induced lung injury.~   "
25613|NCT03231683|"~     The investigators want to investigate the effect of low dose S+ ketamine compared to placebo~     on cumulative morphine consumption at 24 hours in 90 women undergoing open abdominal~     hysterectomy with remifentanil-propofol target controlled infusion (TCI) in KK Women's and~     Children's Hospital. The secondary aims are to investigate the use of low dose S+ ketamine on~     the incidence of nausea, vomiting, pruritus (opioid side effect), sedation score and psycho~     mimetic assessment compared to placebo group. The investigators propose to conduct a double~     blinded, randomized controlled study in women undergoing open abdominal hysterectomy with~     remifentanil-propofol TCI. (1) Treatment Group: intravenous ketamine 0.5 mg/kg at the~     beginning and 0.5 mg/kg 20 minutes before extubation. (2) Control Group: intravenous normal~     saline (as placebo) at the beginning and 20 minutes before extubation.~   "
25614|NCT03231670|"~     Pulmonary bacterial infections such as exacerbations of chronic bronchitis, nosocomial and~     community-acquired pneumonia represent a major public health issue. Antibiotics have shown~     their efficacy by direct antimicrobial activity and their limit particularly in case of~     multidrug-resistant microorganisms or in treating patients with aggravating pathologies.~     Innate immunity could be an alternative or complementary therapeutic pathway. Innate immunity~     receptors bind universal and invariant microbial molecular patterns present in bacteria,~     virus, fungus or parasite. Toll-like Receptors (TLR) activation by microbial agonist~     stimulates the innate immunity response which results in the production of chemokines,~     cytokines, antimicrobial molecules and the recruitment of innate cells.~      The  Pulmonary Infection and Innate Immunity  team of the Immunity and Infection Center in~     Lille (Group of Dr. Sirard and Carnoy) has a long expertise in the study of TLR5 and its~     agonist, the flagellin, a structural protein of bacterial flagella. TLR5 is expressed on the~     cell surface of macrophages, monocytes, dendritic and epithelial cells. Several studies in~     mice have shown the flagellin prophylactic potential during bacterial infections through a~     TLR5 dependent stimulation of innate immunity. Recently, the group of Dr. Sirard and Carnoy~     has shown that flagellin can be used in association with antibiotics to treat Streptococcus~     pneumoniae respiratory infections in mice. The results demonstrate that an agonist of TLR can~     increase the therapeutic index of an antibiotic and improve the pulmonary anti-infectious~     reaction. This innovative approach allows us to consider new antibacterial strategies where~     antibiotics have reached their limit (nosocomial infection, multidrug-resistant bacteria…).~     TLR agonists can activate multiple human cell type. Indeed, blood cells activation by TLR~     agonists have been recently characterized in healthy volunteers.~      However, there is no available data on the ability of TLR agonists to activate cells from~     patients with infectious pneumopathies. A study in these patients is inevitable if one is to~     consider the therapeutic use of agonists in respiratory pathologies.~   "
25615|NCT03231657|"~     Preeclampsia is a leading cause of maternal and neonatal morbidity and mortality worldwide.~     The morbidity and mortality of this condition arises from two main causes: 1) the lack of~     specific and sensible methods for its diagnosis and prognosis, 2) and the fact that the~     course of the disease is often unpredictability at its presentation and speed of progression.~     The majority of deaths are undoubtedly avoidable and are due to a substandard care. Nowadays~     it's known that preeclampsia is a placental disorder that is characterized by an unbalance of~     angiogenic and antiangiogenic factors. It has been recently proven that the ratio of sFlt-1~     to PlGF in women who presented with a clinical suspicion of preeclampsia is useful~     distinguishing between women in whom preeclampsia would develop and those in whom it would~     not. A low ratio also predicted the absence of fetal adverse outcomes in the same time frame.~     In addition this ratio demonstrated to be useful to discriminate among patients that would~     developed maternal or fetal adverse outcome. Correct identification and diagnosis of women at~     risk could potentially prevent all these adverse outcomes thus, clinical experience suggests~     that early detection and monitoring are beneficial.~      EuroPE aims to provide evidence that the re-definition of pre-eclampsia as an entity caused~     by a placental unbalance of angiogenic and anti-angiogenic factors and its incorporation in~     the diagnosis and classification of the disease would improve maternal and neonatal health.~      This will be an open, multicentre, international, randomised controlled trial with an~     intention-to -treat analysis. The study is pragmatic: it will be undertaken to reflect real~     clinical practice rather than the very tightly controlled circumstances of explanatory~     trials. The main objective of this study is to determine the effects of the use of the ratio~     as a diagnostic tool in the definition and classification of PE, as compared with its usual~     definition, in triage and delivery decisions and to see whether this new approach is able to~     improve maternal and perinatal outcomes.~   "
25616|NCT03231644|"~     The FD/MAS Patient Registry is an IRB-approved research study that that invites the patients~     and families to help answer some of the biggest questions about FD/MAS by completing~     questionnaires about their lives with FD or MAS.~      Have you enrolled in the FD/MAS Patient Registry yet? Are you up-to-date on your surveys?~     Take a trip to www.fdmasregistry.org today to learn more about the project, enroll, complete~     your surveys, or make sure you aren't due to provide more info!~      The FD/MAS Patient Registry: Your story powers research.~   "
25617|NCT03231631|"~     Cardiovascular diseases are a leading cause of death worldwide. Some of the risk factors that~     have been identified are considered as be non-modifiable and modifiable. Among the~     non-modifiable, gender, age, race, family history and pathological antecedents such as~     diabetes and hypertension among others are taken into account. The modifiable factors are~     weight, abdominal circumference, habits such as smoking, alcohol consumption, diet and~     especially the EXERCISE.~      In order to modify these risk factors, patients are submitted to a strategy of health~     promotion, disease prevention, pharmacological treatments, non-invasive and invasive~     treatments such as cardiac catheterization, balloon coronary angioplasty and / or stent~     implantation, cardiovascular surgeries etc. However, one of the most important strategies~     that should be of great importance is to involve the patient and his family in these~     treatments through education and follow-up strategies whether it is through the telephone,~     home visit, e-mail, messages, etc. In this way, the patient is brought to a state of~     self-determination and self-awareness that leads him to perform physical activity routinely~     so he can change his cardiovascular risk factors and become a patient adherent to exercise or~     any other treatment. This is where the importance of exercise or aerobic physical activity is~     emphasized, as it is a low-cost activity that can be performed by any type of patient, and~     that results are easily observed in physical and physiological changes that can be~     objectively measurable, such as the levels in serum lipid profile (cholesterol,~     triglycerides, LDL and HDL), or cardiovascular function tests such as stress tests with METs~     indicating increased aerobic capacity (Improvement in ability to withstand a stress test).~      Therefore, the purpose of this study is to submit a group of patients to an education and~     telephone follow-up plan, emphasizing on the importance of performing physical activity with~     the appropriate intensity and frequency so that they can include it within their daily~     routine by itself and ensure the adherence to physical activity.~      Physiological changes that these patients may present as a consequence of the acquired~     routine physical activity by being subject to the education and telephone follow-up plan of~     this research will be measured with serum HDL levels in a clinical laboratory test and MET in~     a stress test.~   "
25618|NCT03231618|"~     This study is a randomized crossover (2 × 3) dietary intervention. 40 male volunteers(20~     normal weight, 20 overweight / obesity, no other serious disease or metabolic abnormalities)~     aged 18-45 years are required to take 3 kinds of isocaloric diets with different amounts of~     macronutrients: low-fat high-carbohydrate diets, low-carbohydrate high-fat diets and~     high-protein low-fat diets. The comparison is made within subject before and after the test~     meal. Each subject takes 6 meals of 3 kinds of diets on 6 separate days with a washout period~     between different diets. The study protocol was approved by the Ethics Committee of Shanghai~     Institutes for Biological Sciences and all participants provided written informed consents.~     The study is the first to investigate among overweight / obesity and normal weight in China~     to clarify:~        1. the relationship between the proportion of macronutrients in diets and the energy~          metabolism efficiency.~        2. the main genetic and non-genetic factors that impact individual energy metabolism, the~          characteristics of metabolic profiling and relative regulatory pathways.~   "
25641|NCT03231319|"~     To compare the different analgesic protocols for patients receiving total hip~     arthroplasty(THA). Patients will divided into 3 groups, which are 1. fascia iliaca~     compartment block with IV-PCA(patient controlled analgesia), 2. femoral nerve and lateral~     femoral cutaneous nerve block with IV-PCA, 3. IV-PCA only.~   "
25619|NCT03231605|"~     Hepatitis A is the most prevalent hepatitis which account for approximately 45% . The~     susceptible population is Children and adolescence, also the morbidity in adult presented~     rising trend in recent years. Therefore, vaccination of Hepatitis A Vaccine play an important~     role in National Immunisation Program(China). The aim of this experiment is to verify the~     effects of experimental group non-inferior than control group. The experiment methods is~     compared the difference of seroconversion rate and Antibody geometric mean titer (GMT)between~     experimental and control Hepatitis A Vaccines. In addition, evaluating the safety of two~     Hepatitis A Vaccines in 18-24 months Chinese Children.~   "
25620|NCT03231592|"~     In 1986, The Pioneer Valley in Western Massachusetts was home to one of the first two~     community supported agriculture (CSA) businesses in the USA. In 2014, there were 6,200 CSAs~     across the states, and today, in the Pioneer Valley alone, there are sixty CSAs. As with many~     parts of the United States, there are too many CSAs competing for the same pool of middle and~     upper-class customers. In his research at the University of Massachusetts in 2014, Mark Paul~     stated CSA farms are trapped in a lose-lose conundrum in which the farmers are not making~     enough money for a living wage, while simultaneously CSA shares are too expensive for many~     community members. The central challenge facing the CSA model moving forward is to provide~     fair compensation to farmers and farm workers, while making shares available at prices that~     can attract more members of the community. (Im)Proving the CSA Model proposes to increase~     consumption of and access to local products AND to develop new market opportunities for farms~     by opening the CSA membership base nationwide to low-income consumers and more price~     conscious middle class consumers. The investigators will do this by researching and~     documenting the health benefits of belonging to a CSA program. The investigators expect the~     resulting data to justify insurance-provided cash wellness benefits for CSA participation,~     much like those currently provided for gym membership. A wellness benefit will provide the~     financial incentive necessary to open CSA programs to lower- and middle-income consumers.~      The two-year research study intends to demonstrate that enrolling community health center~     patients in a Community Supported Agriculture (CSA) program is feasible and leads to dietary~     improvements that would be expected to offer clinical benefits in larger scale studies over~     longer timeframes. To maximize the knowledge gained from participation in this study, the~     investigators will measure several self-reported, laboratory, and clinical outcomes, but the~     primary purpose of this study is to provide pilot data for the model.~      To test this the investigators will implement a randomized controlled clinical trial design,~     with individual-level randomization of 120 participants, assigned in 1:1 ratio to receipt of~     a CSA membership (goal: 60 participants) or enhanced usual care (goal: 60 participants).~   "
25621|NCT03231579|"~     This multi-site study will enroll approximately 200 CLL patients across 7 cancer~     institutions. The aim of the project is to ensure hematology care teams that are~     participating in new value-based reimbursement models have an accurate understanding of the~     evidence and roles of new therapies for relapsed/refractory CLL and best practice supportive~     care protocols to proactively assess, monitor, and manage symptoms to promote successful~     clinical outcomes. Hematology teams at seven health systems across the U.S. will be given~     online clinical training on the latest evidence for treatment planning in CLL along with best~     supportive care practices for patients on novel CLL treatments, prior to using Carevive's~     patient engagement software.~      Once training is complete, CLL patients with relapsed/refractory disease will use the~     Carevive patient portal to report any symptoms at and in between clinic visits.~     Patient-reported and clinical data will be processed by the Carevive rules engine technology~     to generate evidence-based supportive care plans providing patients with direction regarding~     self-management strategies, care coordination for relevant cancer center services, and~     direction on when to go to the emergency department (ED) or call their hematologist based on~     their institution's protocol. On the visits subsequent to the delivery of the care plan,~     patients will report on the perceived effectiveness of the intervention (or barriers to~     non-adherence to the intervention).~      Outcomes focus on the effectiveness of current evidence-based, best supportive care practices~     in improving QoL and mitigating ED visits/hospitalizations. This project will lay the~     foundation for new supportive care delivery models incorporating professional education and~     patient engagement tools to improve clinical outcomes. The research team will collect~     real-world evidence for predictive modeling of symptoms for the relapsed/refractory CLL~     patient population and evaluate the effectiveness of current evidence-based supportive care~     recommendations to inform and improve future practice.~   "
25622|NCT03231566|"~     To determine if education about pain given prior to Knee Arthroplasty will result in better~     outcomes following surgery~   "
25623|NCT03231553|"~     The trial aims to determine whether or not MiQuit (text-message support programme) is~     effective when offered in addition to standard behavioural support for smoking cessation in~     pregnancy.~   "
25624|NCT03231540|"~     This study evaluates the effect of whey protein enriched enteral nutrition in addition to~     exercise training on the preservation of muscle function in critically ill patients.~      One half of patients receive whey protein enriched enteral nutrition with a protein intake of~     1.5 g/kg/day and the other half of patients receive standard enteral nutrition with a protein~     intake of 1 g/kg/day.~   "
25625|NCT03231527|"~     real-life retrospective multicentric database for the analysis of the long term outcomes of~     total arterial CABG in comparison to saphenous vein based CABG~   "
25626|NCT03231514|"~     The study will examine the performance and body composition effects of ketogenic vs~     carbohydrate-based diets, determine the carbohydrate tolerance (carbohydrate threshold) for~     active individuals on a ketogenic diet, and then, reexamine the performance and body~     composition effects when the diets are modified with supplemental carbohydrate up to the~     newly defined ketogenic threshold.~   "
25627|NCT03231501|"~     This is an open-label study, to evaluated epitinib, which is a selective epidermal growth~     factor receptor tyrosine kinase inhibitor (EGFR TKI), to treat glioblastoma patients with~     EGFR gene amplification. As epitinib could cross blood-brain barrier (BBB), inhibition of~     EGFR may provide a novel mechanism in treating glioblastoma.~   "
25628|NCT03231488|"~     Can mindfulness help with attention and emotion difficulties after a brain injury?~      People who have a brain injury often have problems with their attention and emotions. This~     study will see if a short mindfulness task can help with these problems. So far, there are~     not many studies looking at this and those that do show mixed results. When being mindful~     someone is aware of their attention and focuses on the present moment without passing~     judgement. This study focuses on over-selectivity and selective attention to threat after a~     brain injury. These are two concepts involved in attention and emotion problems.~     Over-selectivity is when someone focuses on only one thing around them and misses other key~     things. Selective attention to threat is when someone's focus is drawn to something around~     them that is seen as threatening. This has been shown to cause and keep anxious feelings~     going. This research will see if a short mindfulness task can help those with a brain injury~     by reducing overselectivity and selective attention to threat on two tasks. Participants will~     be recruited from NHS and non-NHS brain injury services. The study will take around two hours~     to complete for each participant. In summary, this study looks to see if a specific~     mindfulness exercise can be helpful for specific attention and emotion problems. It could be~     a first step in making treatment better and giving more treatment options for those with a~     brain injury.~   "
25706|NCT03230448|"~     There is a strong link between the alcohol consumption and the suicidal risk. Indeed there is~     an increase of the risk of suicide in case of chronic or acute alcohol consumption. However~     why the alcohol consumption increase the suicidal risk is unknown.~      The hypothesis of this study is that the alcohol consumption induced disinhibition and~     facilitates the suicide attempt without premeditation~   "
25629|NCT03231475|"~     This study will treat patients with advanced NSCLC who have already received at least one~     course of specific anti-cancer treatment but the tumour has started to re-grow following that~     treatment. This is the first time this drug has ever been tested in patients, and so it will~     help to understand what type of side effects may occur with the drug treatment, it will~     measure the levels of drug in the body, it will also measure the anti-cancer activity. By~     using these pieces of information together the best dose of this drug to use in further~     clinical trials will be selected.~   "
25630|NCT03231462|"~     This prospective cohort study examines the impact of perioperative physical activity on~     postoperative pulmonary complications among esophageal cancer patients.~   "
25631|NCT03231449|"~     FEVRIER study is an observatory of hospitalizations in cardiology units in sub-Saharan~     Africa.~   "
25632|NCT03231436|"~     The study is designed to compare the effectiveness of spinal anesthesia performed with fixed~     dose of hyperbaric bupivacaine regardless of patient's height and weight and anesthesia with~     the dose of bupivacaine that is adjusted to their height. Our clinical experience shows that~     spinal anesthesia using specific, relatively high dose of hyperbaric bupivacaine combined~     with opioid is very effective, regardless of parturient's weight and height, provides very~     good surgical conditions and assures patient's comfort while the rate of anesthesia - related~     complications is similar or less. Therefore, using height-adjusted protocols, although~     preferred in some centres, might not be necessary in order to provide good anaesthesia for~     cesarean delivery. Fixed dose regimen may have some additional advantages in obstetric~     anesthesia settings, as many of cesareans are performed out of hours, giving less room for~     mistakes in less experienced hands.~      Two groups of parturients undergoing cesarean section are to be compared: anesthetized with~     fixed-dose regimen (intervention group) and anesthetized with height-adjusted dose regimen~     (control group). Patients are going to be randomized to one of the above groups, two~     anesthetists will be involved in anesthetic procedure: anesthetist that looks after the~     patient throughout the procedure will be blinded to the dose of anesthetic given~     intrathecally. Therefore his judgment of anesthetic effectiveness is not going to be biased~     and all patients will receive the same perioperative care in terms of fluid therapy,~     management of possible anesthesia - related complications and postoperative pain control.~      Rate of effective spinal anesthetics, defined as adequate block level and no need for~     additional intraoperative analgesia has been established as primary outcome measure.~     Secondary outcome measures are rate of complications and amount of opioids used~     postoperatively. These are going to be statistically compared.~   "
25633|NCT03231423|"~     Introduction RYGB surgeon; Have become increasingly morbid obesity treatment methods with~     improvements in minimally invasive surgery. Ensuring patient comfort and early return to life~     are the criteria that should be given priority in this treatment method. The purpose of this~     study is to determine the use of drain, which closely affects these criteria; And the effect~     on patient comfort.~   "
25634|NCT03231410|"~     This study is designed to identify novel predictors of vascular access success or failure in~     chronic kidney disease patients. Despite efforts to improve placement of arteriovenous~     fistula (AVF) the primary failure rates are reported as high as 20-50%, but standard tools~     like ultrasound cannot inform the clinician sufficiently to accurately predict success or~     failure.~      The aim of this study is to perform enhanced assessments of arterial health preoperatively~     and correlate these measurements with vascular lesions (microscopic tissue changes and~     monocyte infiltration) and early AVF outcome.~      Activation of monocytes in uremia condition is responsible for endothelium dysfunction,~     intimal hyperplasia and atherosclerosis. The investigators expect that stiff arteries caused~     by monocyte dysfunction refer to the poor distensability and probably longer maturation time.~   "
25635|NCT03231397|"~     Eligible subjects in this study will have either a known abdominal aortic aneurysm (AAA) or~     because they do not have an AAA (control group).~      The purpose of this research study is to further study, through FEA, changes that occur in~     the mechanical properties of the aortic wall. The investigator will compare two radiotracers,~     18F-FDG and 11C-PBR28 to determine if one provides more useful and reliable information about~     inflammation. 18F-FDG and 11C-PBR28 are radioactive drugs that will be used for imaging~     during the PET-CT scan. The investigator will also compare the results describing the~     mechanical properties of the AAA wall to the degree of inflammation in that wall as~     determined by PET-CT imaging to define new and better predictors of AAA growth and/or~     rupture.~   "
25636|NCT03231384|"~     The purpose of this study is to determine the safety and feasibility of remote limb ischemic~     conditioning(RIC) in acute ischemic stroke patients who received r-tPA thrombolytic therapy.~   "
25637|NCT03231371|"~     Heart transplantation is a life-sustaining therapy that allows patients with either~     congenital or acquired heart disease and severe cardiac dysfunction to survive. Over time,~     however, the transplanted heart can develop problems. One of the more common and troubling~     problems is the development of stenoses, or narrowings, within the coronary arteries. These~     narrowings, technically referred to as coronary artery vasculopathy (CAV for short), account~     for the single most common cause of death or need for repeat heart transplant in persons more~     than one year post-transplant. Traditionally, CAV has been diagnosed at cardiac~     catheterization using coronary angiography (where dye is directly injected into the coronary~     blood vessels and viewed using special x-ray equipment called fluoroscopy). There is no good~     treatment for CAV aside from treatment of symptoms and listing for repeat heart~     transplantation. The goal of this study is to test several newer methods of diagnosing CAV.~     The first is called coronary flow reserve (catheterization test). The second is called~     Endo-PAT (a finger probe test) and the third is called contrast-enhanced cardiac MRI (MRI~     test, only for patients 12 and older). The older method (coronary angiography) will still be~     used in all cases, in addition to the new tests The goal is, one day, to be able to diagnose~     patients with CAV earlier in the course, prior to a patient's development of abnormal~     angiograms. If this can be done, it is possible that better therapies will be able to be used~     to stop or even reverse the development of CAV, perhaps reducing, or at least delaying, the~     need for repeat heart transplantation.~   "
25638|NCT03231358|"~     The purpose of this study is to test the efficacy of Our Family Our Future, an integrated~     intervention for preventing HIV and depression onset among adolescents.~   "
25639|NCT03231345|"~     Difficult venous access in some patients such as those with obesity, IV drug use, chronic~     illness, or vascular pathology often causes increased discomfort and delayed patient care due~     to multiple attempts to gain venous access. If access is achieved at all, it usually results~     in a much smaller catheter than needed to provide optimal care for the patient.~     Ultrasound-guided placement of a peripheral IV in the internal jugular vein is common in the~     investigators' emergency department and is gaining popularity across the US. This study~     investigates the utility and safety of placing an ultrasound-guided peripheral IV catheter in~     the internal jugular vein.~   "
30255|NCT03171025|"~     This is a phase 2, single arm, open label trial to evaluate the rate of failure free survival~     at 2 years after start of study treatment with adjuvant nivolumab in adult subjects who~     undergo chemoradiation for localized bladder cancer.~   "
25642|NCT03231306|"~     This is a phase II open label study that will evaluate children ≥ 1 year of age and adults~     with neurofibromatosis type 1 (NF1) and plexiform neurofibromas treated with the MEK~     inhibitor, binimetinib. The primary objective is to determine if there is an adequate level~     of disease responsiveness to binimetinib in children and adults with NF1 and inoperable~     plexiform neurofibromas. The objective response to binimetinib is defined as ≥ 20% decrease~     in tumor volume reduction by 12 courses.~   "
25643|NCT03231293|"~     This study evaluates the effectiveness of fimasartan-based antihypertensive treatment and~     prognosis in post-acute phase of ischemic stroke or transient ischemic attack patients. All~     participants will receive fimasartan, and the investigators will follow them up for 6 months.~   "
25644|NCT03231280|"~     This study evaluates a novel agent, SB-061, for the treatment of osteoarthritis of the knee.~     Half of the patients will receive the agent via intra-articular injection and half will~     receive a placebo injection.~   "
25645|NCT03231267|"~     This research focuses on antibiotic resistant bacteria that may reside in the digestive tract~     (intestinal flora) of everyone.~      When we develop an infection, the bacteria in question is, often, already present in our~     flora. Face to the growing phenomenon of multi-resistance, which is a public health problem,~     it is essential to follow the frequency of these bacteria but also to find new strategies and~     effective means to fight against their spread.~      It has been discovered long time ago that it exists viruses able of destroying bacteria: they~     have been called bacteriophages .They was used before the arrival of antibiotics for the~     treatment of various infections (phagotherapy). Today, with the problems of resistance,~     phagotherapy could become a good way to fight against infections with bacteria very resistant~     but also a way to remove the resistant bacteria that are present in our digestive flora.~      Moreover, it is known that these viruses of bacteria are present everywhere in the~     environment (waters, soils, human digestive tract and animal), it is important to check their~     presence in our digestive tract. Our objective is to study if the presence of these phages~     prevents resistant bacteria from set up in our digestive flora.~      To answer the question, it is planned to include 460 people hospitalized in intensive care~     unit (resuscitation). The choice of this unit is linked to the fact that the monitoring of~     resistant bacteria is carried out regularly during the hospitalization. Three resuscitation~     services were recruited: 2 in Saint Antoine Hospital and 1 in Tenon Hospital. On stool~     samples collected at different times of the stay (admission and then during the stay), we~     will look for 2 types of bacteria and viruses capable of destroying them.~   "
25646|NCT03231254|"~     Study Objective: To explore the differences in predicted therapeutic outcome of OA and~     optimal protrusion position determined by Remotely Controlled Mandibular Positioner (RCMP)~     with overnight PSG in Quebec versus Shenyang patients with OSA.~      Design: A prospective, inter-ethnic pilot study. Setting: Two Standard sleep disorder~     clinical care in Quebec (Canada) and Shenyang (China), with oral appliance titration tests~     performed in sleep laboratory.~      Participants: Consecutive specific OSA patients, who are potential candidates for treatment~     of OSA with an oral appliance (n=100, 50 Canadian, 50 Chinese), will be recruited from a~     sleep center or respirologists, psychiatrists, otolaryngologist and dentists practicing with~     broad inclusion criteria (age: 20-75 years, AHI:15-50/h; BMI＜40 kg/m2).~      Interventions: A mandibular protrusive titration study in the PSG lab using a RCMP not only~     predicts the eventual therapeutic outcome but also prospectively determines Optimal~     Protrusive Position (OPP) for participants predicted to be therapeutically successful with OA~     therapy. One goal of this study is to identify OA favorable candidates by physicians using~     prospectively and explicitly designed criteria. Analyses of the predicted therapeutic outcome~     of OA and OPP between the two ethnic populations (patients in Quebec and Shenyang) will be~     processed after matching for OSA severity.~   "
25647|NCT03231241|"~     Study is aimed at determining why some patients with episodic headache proceed to chronic~     daily or near daily headaches. The Investigators seek to discover differences in brain~     anatomy and function, composition of cerebrospinal fluid, blood products, genetics, and~     patient phenotypes that might help explain this process.~   "
25648|NCT03231228|"~     This is a Phase 4, open-label, single-dose, parallel-group, multicenter, safety study of~     cefazolin (1 g or 2 g) in pediatric subjects between 10 and 17 years of age (inclusive)~     scheduled for surgery.~   "
25649|NCT03231215|"~     The purpose of this study was to evaluate the efficacy of dexamethasone when added to~     epidural bupivacaine on the duration of postoperative analgesia in patients underwent total~     knee replacement surgery.~   "
25650|NCT03231202|"~     The primary objective is to compare the failure rate due to splenic bleeding between the~     patients undergoing pre-emptive splenic arterial embolization (SAE) as part of non-operative~     management (NOM) and the patients not undergoing SAE. We hypothesize that the use of~     pre-emptive SAE will decrease the delayed bleeding rate and increase the success rate of NOM.~   "
25651|NCT03231189|"~     When a patient is newly diagnosed of systolic dysfunction without obvious etiology (such as~     rhythmic, ischemic, or valvular disease), most of the time a coronary angiography is~     performed. In this situation, the investigators aim to evaluate a strategy with CMR as the~     front line exam, and invasive coronary angiography performed only in case of ischemic scar on~     CMR~   "
25652|NCT03231176|"~     This protocol for Varlitinib is developed for the treatment of Biliary Tract Cancer.~     Varlitinib (also known as ASLAN001) is a small-molecule, adenosine triphosphate competitive~     inhibitor of the tyrosine kinases - epidermal growth factor receptor (EGFR), human epidermal~     growth factor receptor (HER)2, and HER4. Varlitinib may be beneficial to subjects with cancer~     by simultaneous inhibition of these receptors. The purpose of this study is to determine the~     safety and efficacy of Varlitinib in combination with capecitabine for the treatment of~     Biliary Tract Cancer. Eligible patients will receive Varlitinib plus capecitabine.~   "
25653|NCT03231163|"~     The objective of the study is to determine whether music has any effect on resting metabolic~     rate (RMR), which is the amount of energy expended at rest. There is currently conflicting~     research on how music affects RMR. One problem with RMR testing is that participants often~     fall asleep during the test. There can be a 5-10% difference in the metabolic rate between~     rest and sleep. If no change in RMR is observed, playing music during an RMR test could be a~     potential strategy to prevent participants from falling asleep. Participants will undergo RMR~     measurements while listening to no music, relaxing classical music, and self-selected~     classical music.~   "
25654|NCT03231150|"~     The primary aim of this clinical experiment is to compare, in terms of pain relief measured~     using the 10-cm visual analog scale (VAS) pain score (5-7), the clinical results of~     ultrasound-guided injection (USGI) versus anatomic topography-guided injection (ATGI) of~     corticosteroid for the treatment of proximal PF. Secondary aims will be to compare~     foot-related quality of life, as measured using the Foot Function Index (FFI)and the Bristol~     Foot Score (BFS), between the injection groups, and also to compare the pre-injection to~     late-term post-injection thickness of the plantar fascia as measured in the nested USGI~     group.~   "
25655|NCT03231137|"~     This study was conducted to compare post-extraction augmented sockets using Atorvastatin~     loaded in Plasma rich in growth factors derived fibrin scaffold (PRGF/ATV) or direct~     application of Atorvastatin (ATV) gel or platelet rich fibrin (PRF) or (PRGF) and~     spontaneously healed socket (Control) both clinically and by histomorphometric analysis of~     formed bone quality.~   "
25656|NCT03231124|"~     This trial will investigate the safety, tolerability and pharmacokinetic (PK) data of LEO~     32731 (and major human metabolite LEO 40815) in healthy male Japanese subjects. The primary~     objective is the assessment of PK in Japanese subjects.~      Data obtained from this trial will be used to compare with existing data from the other Phase~     1 trials. This comparison of safety and PK profiles between Japanese and Caucasian subjects~     will allow the inclusion of Japanese patients into Phase 2b studies.~   "
25657|NCT03231111|"~     The Effectiveness of Using Preventive Multimedia Teaching Program in Lung Cancer Women~     Receiving Targeted Therapy on Skin-Related Quality of Life~   "
25658|NCT03231098|"~     The objective of this study is to investigate the use of patient throat gargle as an~     alternative to throat swabbing for the diagnosis of pharyngitis caused by Group A β-Hemolytic~     Streptococcus (GABHS) infection, also known as strep throat.~   "
25659|NCT03231085|"~     Oral iron is commonly used in conjunction with EPO preoperatively for hemorrhagic surgeries~     in children and especially in the surgery of craniosynostosis. The bioavailability of oral~     iron is low and compliance with treatment is inconsistent. The aim of this study is to~     evaluate whether the use of ferric carboxymaltose by injection, which has a much better~     bioavailability, would make it possible to increase the preoperative hemoglobin level more~     effectively and thus reduce the risk of perioperative blood transfusion .~   "
25660|NCT03231072|"~     Evacuation of pleural effusion (PE) represents a disputable therapy in mechanically~     ventilated patients. Patients on mechanical ventilation indicated by the physician to pleural~     fluid evacuation will be monitored throughout the procedure by electrical impedance~     tomography (EIT) and concurrently end-expiratory lung volume (EELV) will be measured in order~     to describe impact of PE evacuation on aeration and ventilation of the lungs.~   "
25661|NCT03231059|"~     The GLOBAL LEADERS Adjudication Sub-StudY, GLASSY, is based on a re-assessment of all the~     events reported in the dataset of the parent trial (COMPARATIVE EFFECTIVENESS OF 1 MONTH OF~     TICAGRELOR PLUS ASPIRIN FOLLOWED BY TICAGRELOR MONOTHERAPY VERSUS A CURRENT-DAY INTENSIVE~     DUAL ANTIPLATELET THERAPY IN ALL-COMERS PATIENTS UNDERGOING PERCUTANEOUS CORONARY~     INTERVENTION WITH BIVALIRUDIN AND BIOMATRIX FAMILY DRUG-ELUTING STENT USE) by an independent~     Clinical Event Committee (CEC), composed of three physicians not involved in the main trial.~     The substudy include the first 19 top-enrolling sites of the GLOBAL LEADERS to reach the~     estimated sample size of 7,186 patients for the two co-primary outcomes of death, any~     non-fatal myocardial infarction, any non-fatal stroke or urgent target vessel~     revascularization and bleeding events classified as 3 or 5 according to the Bleeding Academic~     Research Consortium (BARC) criteria. To ensure a comprehensive assessment of clinical events,~     a triggers logic is adopted to identify other potential events qualifying for study endpoints~     but not reported as such by local investigators.~   "
25662|NCT03231046|"~     The objective of this research is to evaluate functional validation of the CBCT-US fusion for~     the Clear Guide SCENERGY system, as well as to evaluate benefits derived from system~     performance.~   "
25663|NCT03231033|"~     Pulmonary alveolar proteinosis (PAP) is a syndrome of surfactant accumulation, respiratory~     failure, and innate immune deficiency for which therapy remains limited to whole lung lavage~     (WLL), an invasive physical procedure to remove surfactant unavailable at most medical~     centers. While PAP occurs in multiple diseases affecting men, women, and children of all ages~     and ethnic origins, in 85% of patients, it occurs as an idiopathic disease associated with~     neutralizing GM-CSF autoantibodies. Basic science and translational research has shown that~     idiopathic PAP is an autoimmune disease in which disruption of GM-CSF signaling impairs the~     ability of alveolar macrophages to clear surfactant and perform host defense functions.~      Recently, it has been shown that cholesterol toxicity drives pathogenesis in alveolar~     macrophages from GM-CSF deficient (Csf2-/-) mice and patients with autoimmune PAP. Loss of~     GM-CSF signaling reduces PU.1/CEBP-mediated expression of PPARγ and its downstream target~     ABCG1 (a cholesterol exporter important in macrophages). The cell responds by esterifying and~     storing cholesterol in vesicles to reduce toxicity. Eventually, vesicles fill the cell,~     impair intracellular transport and reduce uptake and clearance of surfactant from the lung~     surface resulting in disease manifestations. Recent data indicates that pioglitazone, a PPARγ~     agonist currently approved by the FDA for human use, increases cholesterol/surfactant~     clearance by alveolar macrophages from autoimmune PAP patients and Csf2-/- mice. Importantly,~     pioglitazone significantly reduced the severity of PAP lung disease in Csf2-/- mice after~     several months of therapy. Together, these observations suggest pioglitazone could be~     'repurposed' as pharmacologic therapy for PAP.~   "
25664|NCT03231020|"~     The purpose of this study is to provide a rich description of the parental perspectives of~     utilizing a mHealth application for data transfer during the single ventricle interstage~     monitoring period. A gap in the body of knowledge of single ventricle cardiac disease~     interstage will be explored with these research questions: 1) How do parents of children (< 5~     years of age) with single ventricle disease describe their experiences using a mHealth~     application during the interstage period (first 6-12 months of child's life)? And 2) How do~     these experiences influence their decision making for use of the mHealth application?~   "
25756|NCT03229798|"~     Study KCC-SMT-002, is a Phase 1, single-site, open-label, non-randomized, crossover, flexible~     dose design study to investigate the pharmacokinetic (PK) and safety comparing the Sofusa™~     system with sumatriptan (KC5010) to Imitrex® oral tablets in 17 healthy volunteers.~   "
25665|NCT03231007|"~     The study is a multicentre evaluation of maternity care delivered through the Saving Babies'~     Lives care bundle using both quantitative and qualitative methodologies. The study will be~     conducted in twenty NHS Hospital Trusts from six NHS Strategic Clinical Networks totalling~     approximately 100,000 births. It involves participation by both service users and care~     providers.~      To determine the impact of the care bundle on pregnancy outcomes, birth data and other~     clinical measures will be extracted from maternity databases and case-note audit from before~     and after implementation. Additionally, this study will employ questionnaires with~     organisational leads and review clinical guidelines to assess how resources, leadership and~     governance may affect implementation in diverse hospital settings. The cost of implementing~     the care bundle, and the cost per stillbirth avoided, will also be estimated as part of a~     health economic analysis. The views and experiences of service users and service providers~     towards maternity care in relation to the care bundle will be also be sought using~     questionnaires.~      This study will provide practice-based evidence to advance knowledge about the processes that~     underpin successful implementation of the care bundle so that it can be further developed and~     refined. This has the potential to translate into substantial improvements in the rate of~     late stillbirth in the UK should the care bundle be proved effective.~   "
25666|NCT03230994|"~     To set up a Cooperative Network by enrolling 5000 patients with Adenomyosis(AM) from multiple~     centers.Based on the Network platform and Database,the investigators try to explore the~     diagnostic strategies for AM and carry out epidemiological survey on the semeiology of AM.In~     addiction，the investigators expect to conduct research on the effect and the follow-up~     fertility outcomes of different medical or surgical treatment, the etiology of AM and~     endometriosis,the perspective investigation of the malignant transformation of AM ;the~     high-risk factors of AM,and finally propel the formation of Expert Consensus and Clinical~     Guidelines about AM which suitable to chinese conditions.~   "
25667|NCT03230981|"~     The aim of this pilot study is to assess the ability of a new optical coherence tomography~     system to obtain information on biomechanics of the cornea.~   "
25668|NCT03230968|"~     Background. Mexico is lacking guidelines that provide an integral approach for the prevention~     and control of respiratory diseases in adults. The World Health Organization (WHO) proposed a~     Practical Approach to Lung Health (PAL) using generic guidelines to be used in primary~     health care settings for diagnosis and treatment of respiratory diseases. These guidelines~     were adapted to the Mexican context as AIRE campaign by the Instituto Nacional de~     Enfermedades Respiratorias, Mexico. Objective. To evaluate the feasibility and effectiveness~     of implementing a model of care for respiratory diseases in adults based on AIRE guidelines,.~     Materials and methods. Prospective quasi-experimental pre-post study. During 03-08/2013~     (phase 1), investigators recruited consenting subjects older than 15 years of age seeking~     medical care in primary care centers in Orizaba, Veracruz. Researchers investigated~     sociodemographic, epidemiological and clinical information before consultation. On patients~     who had been diagnosed with respiratory disease by a physician, researchers investigated~     prescribed treatment on leaving the physician´s office. A month later conducted a home visit~     to investigate clinical outcome. During 09/2014 we trained doctors from the participating~     health centers in AIRE guidelines. From 10/2014 to 03/2015 (phase 2) researchers again~     surveyed all consenting subjects older than 15 years of age who received health services in~     the same health centers following the same procedures as in phase 1.~   "
25669|NCT03230955|"~     Pragmatic randomized clinical trial, single-blind, with allocation 2:1 [Intervention Group~     (IG) and control group (CG)] in 5 acute hospitals. The IG will receive telephone assistance~     to quit smoking (including psychological and psycho-educational support and pharmacological~     treatment advice, if required) proactively for 12 months, and the CG only brief counselling~     after discharge.~      To assess the effectiveness of a multicomponent and motivational intensive telephone-based~     intervention to stop smoking (quit line) addressed to smokers with mental disorders~     discharged from hospitals.~   "
25670|NCT03230942|"~     This study aims to evaluate the effect of preoperative patient education program on~     functional mobility, gait, postural control, and kinesiophobia level in subjects with TKA.~     Patients of both gender will be recruited unilaterally in the city of Florianopolis and~     referred by an orthopedist to the Physiotherapy Clinic of UDESC. They are divided into two~     groups: one that will receive verbal guidance and a booklet with related information such as~     your physical condition as well as signs and symptoms in the postoperative period and a group~     that will receive only verbal guidance.Both groups will be evaluated by a blind evaluator in~     the preoperative and postoperative periods (6 weeks and 6 months). The evaluations will be~     divided into five stages. Anthropometric measurements of the individual will be made and then~     the WOMAC functionality questionnaire and the Kinesiophobia Cover Scale will be applied.Then~     the individual will walk for 5 meters for three-dimensional gait analysis and~     electromyographic analysis of the quadriceps and femoral biceps. The evaluation of functional~     mobility by Timed Up And Go and assessment of postural control in an equilibrium platform~     will also be performed. Statistical data will be analyzed by analysis of variance 3x2~     considering factor time (pre, post 6 weeks and post 6 months) and groups (with and without~     information leaflet). The value of p will be 0.05.~   "
25682|NCT03230773|"~     Survival from out-of-hospital cardiac arrest is time critical and diminishes rapidly without~     appropriate intervention. Bystander CPR at least doubles the chances of survival and the~     additional use of a public access defibrillator (PAD) can again double overall survival~     rates. PADs are designed to be easy and simple to use, but whether untrained bystanders can~     use them safely and effectively is unknown. This study will aim to assess the ability of~     untrained bystanders to deploy a PAD in a simulated cardiac arrest.~   "
25692|NCT03230630|"~     Pre-clinical and clinical studies have demonstrated that melatonin has cardio-protection~     effects. Melatonin has anti-inflammatory, antioxidant, antihypertensive, antithrombotic and~     antilipaemic properties, which plays important roles in a variety of cardiovascular~     pathophysiologic processes. Nocturnal melatonin levels decreased after AMI, and lower serum~     melatonin concentrations after AMI are associated with more heart failure and cardiac death~     and left ventricular remodeling. Moreover in women with increased BMI, lower melatonin~     secretion is associated with higher risks of MI. Early-morning blood collection is easier in~     clinical practice. Therefore, the investigators carried out a cohort study to evaluate the~     prognostic value of plasma soluble melatonin in hospitalized patients with acute myocardial~     infarction (AMI).~   "
25671|NCT03230929|"~     Currently, a lot of equipments based on Bispectral index (BIS) is used clinically in order to~     measure the depth of anesthesia. Although BIS is used for the measurement of the presence of~     consciousness or degree of sedation during general anesthesia, it could be influenced by~     factors that affect or interfere with the activity of EEG because it is a numerical value~     which is measured by analyzing EEG. The BIS electrode for EEG analysis should be attached to~     the patient's forehead and the EEG signal is 0.5 - 30 Hz, the EMG signal is 30 - 300 Hz, and~     the BIS analyzes the 0 - 47 Hz signal. Therefore, 30 -47 Hz EMG signal may influence the BIS~     value and the BIS value may differ from the actual. In patients with complete muscle~     relaxation, the change in BIS varies in proportion to the concentration of anesthetic, but in~     a state with less muscle relaxation or arousal period of anesthesia when recovery of muscle~     relaxation occurs, BIS value may not accurately reflects the change in the depth of~     anesthesia. Although there is a study on the influence of the degree of muscle relaxation on~     BIS value, there is no study on whether phase lag entropy (PLE) measuring anesthesia depth~     based on different mechanism from BIS is affected by status of muscle relaxation. After~     measuring BIS and PLE at the same time, I will compare both of them and investigate the~     reliability of the measurement of the depth of anesthesia of PLE and how electromyogram~     activity affects PLE.~   "
25672|NCT03230916|"~     This study aims to obtain plasma pharmacokinetic (PK) data and characterize the PK profile of~     imipenem (IMI), cilastatin (CIL), and relebactam (REL) following administration of a single~     intravenous (IV) dose of MK-7655A (a fixed ratio combination of~     imipenem/cilastatin/relebactam), hereafter referred to as IMI/REL.~   "
25673|NCT03230903|"~     The study aims to evaluate the efficacy of the MS HAT (Multiple Sclerosis Home Automated~     Telemanagement) System as an adjunct to the current standard of medical care for patients~     with MS (PwMS). The individual patient with MS will be the unit of analysis. For each~     participant, the investigators will assess the effect of Home Automated Telemanagement (HAT)~     on functional outcomes, levels of disablement including impairment, activity and~     participation, socio-behavioral parameters, and satisfaction with medical care as described~     below.~   "
25674|NCT03230890|"~     The purpose of this study is to evaluate the effects associated with the use of in-office~     High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) for~     participants with symptoms of military-related traumatic stress. This is a single site,~     non-randomized, open label pilot study. Outcome measures collected before, and after the~     intervention evaluate effects on self-reported symptoms, autonomic cardiovascular regulation,~     functional measures, blood and saliva biomarkers of stress and inflammation, and network~     connectivity on whole brain, rest MRI testing. Self-reported symptom outcomes will also be~     collected remotely at 1, 3, and 6 months after completion of intervention. The study will~     assess feasibility in this cohort, focused on the Special Operations community, will provide~     estimates of effect size, and durability of symptom changes, while providing important pilot~     data for future proposals and investigations.~   "
25675|NCT03230864|"~     This study evaluates the efficacy of 10 mg/day Lu AF35700 on symptoms of schizophrenia in~     patients with early-in-disease (ED) or late-in-disease (LD) treatment-resistant schizophrenia~     (TRS)~   "
25676|NCT03230851|"~     A total of 210 coronary atherosclerosis patients without indications for stent implantation~     are included. The baseline values of platelet aggregation rate, plasmaThromboxaneB2 and~     urinary 11-dh ThromboxaneB2 are measured by Light Transmittance Aggregometry method and ELISA~     after aspirin 100 mg /d ≥5d. Then the patients are randomly divided into 7 groups: Group1:~     aspirin 100 mg/d; Group2: aspirin 100 mg /2d; Groups3: aspirin 100 mg / 3d; Groups4: morning~     50mg evening 50mg; Group5: aspirin 75mg / d; Group6: aspirin 50mg / d; Group7: indobufen100mg~     bid. One month later,arachidonic acid-induced platelet aggregation rate , plasma TXB2 and~     urine 11-dh TXB2 are analyzed again. All patients are followed-up for 1 year. The stomach~     Intestinal reactions, small bleeding events are recorded.~   "
25677|NCT03230838|"~     This study aims to evaluate the safety and tolerability of MK-7625A (ceftolozane/tazobactam)~     compared with that of meropenem in pediatric participants with cUTI, including~     pyelonephritis.~   "
25678|NCT03230825|"~     We speculate that the use of combined oral contraceptives may be a possible solution to~     promote the management of retained pregnancy products versus expectant management. By~     withdrawing the pill, the endometrium is expected to shed in a synchronized fashion (estrogen~     and progestin withdrawal bleeding and may also shed the retained products of conception and~     avoid a surgical procedure with its related potential complications.~   "
25679|NCT03230812|"~     the results from animal studies and preliminary human studies show that carnitine~     availability and acetylcarnitine concentrations are low in insulin resistant states such as~     with type 2 diabetes mellitus. However, in humans, carnitine supplementation is sometimes~     beneficial, but not in everyone. We hypothesize that this variability in response is due to~     differences between individuals in the amount of carnitine in the muscle i.e. only subjects~     with a low initial carnitine status will benefit from supplementation. The state of the art~     non-invasive magnetic resonance spectroscopy method allows us to identify patients with low~     vs high muscle acetylcarnitine status. Here we aim to - for the first time - make the~     translational step to humans and test the hypothesis that carnitine supplementation in type 2~     diabetic patients with initially low carnitine status enhances metabolic flexibility and~     insulin sensitivity to a greater extent than in subjects with an initially high carnitine~     status.~   "
25680|NCT03230799|"~     In this study, the investigators give participants who had a lens implantation before a~     secondary intraocular lens implantation in the purpose of reduce complications of surgeries~     for dense cataract , and report a prospective, non-randomized controlled study aiming at~     comparison of minimal invasive lens surgery and traditional cataract surgery for treating~     congenital cataracts~   "
25681|NCT03230786|"~     This is a multicentre, randomized, double-blind, placebo-controlled, parallel-group Phase II~     trial of twelve weeks of KBP-042 administered as daily s.c. injections in subjects with Type~     2 Diabetes Mellitus with inadequate glycaemic control while treated with a stable dose of~     metformin.~      The trial is planned to be performed in Czech Republic, Denmark, Moldova, Poland, Romania and~     United Kingdom~   "
25757|NCT03229785|"~     This study aims to look at whether human umbilical cord blood plasma (HUCBP) is safe for~     intravascular (iv) administration; and whether it provides any reversal of frailty or other~     age-related biological measures.~   "
25683|NCT03230760|"~     Breast engorgement which may manifest swell, throb, and cause mild to extreme pain is the~     common difficulty for breast feeding woman. It occurs in the mammary glands due to expansion~     and pressure exerted by the synthesis and storage of breast milk and it usually happens when~     the breasts switch from colostrums to mature milk. However, engorgement can also happen if~     lactating women miss several nursing and not enough milk is expressed from the breasts. It~     can be exacerbated by insufficient breastfeeding and/or blocked milk ducts. Engorgement may~     lead to mastitis and untreated engorgement puts pressure on the milk ducts, often causing a~     plugged duct.~      According the meridian theory, the investigators propose the acupuncture treatment for~     patients of breast engorgement.~      The investigators will include 60 patients and measure the acupuncture effect. The inclusion~     criteria are women with breast engorgement and 20 years old or older. Exclusion standards are~     patients with: 1. diabetes mellitus 2. Psychological disease or mental illness 3. Fever > 38~     degrees Celsius 4. Mastitis 5.analgetics or anti - inflammatory agents used 6. ultrasound~     therapy applied~   "
25684|NCT03230734|"~     Randomized, multicentre phase II trial of the sequencing of Radium-223 and Docetaxel plus~     prednisone in symptomatic bone-only metastatic castration-resistant prostate cancer (mCRPC)~      Open-label, randomized phase II trial in patients with symptomatic bone-only metastatic~     castration-resistant prostate cancer. Eligible patients are randomly assigned into two arms:~        -  Arm A: radium-223 initially followed by docetaxel plus prednisone at the time of~          progression (the second step is optional according to clinical evolution of disease)~        -  Arm B: docetaxel plus prednisone initially followed by radium-223 at the time of~          progression (the second step is optional according to clinical evolution of disease).~   "
25685|NCT03230721|"~     Today, endoscopic enucleation of the prostate (EEP) has been recognized a method of choice~     for treatment of benign prostatic hyperplasia (BPH) of any size, including large-sized glands~     (>80 cc). The goal of our study was to compare perioperative efficacy, functional outcomes~     and safety of different techniques of endoscopic enucleation of the prostate (monopolar~     enucleation, holmium laser enucleation, thulium laser enucleation) in a single center.~   "
25686|NCT03230708|"~     This study makes an observation over the objective response rate of autologous erythrocytes~     derived microparticles packaging methotrexate peritoneal perfusion and systemic therapy~     combination in the treatment of malignant ascites. All the participants will randomly receive~     the treatment of autologous erythrocytes derived microparticles packaging methotrexate~     peritoneal perfusion and systemic therapy combination or convention drugs peritoneal~     perfusion and systemic therapy combination.~   "
25687|NCT03230695|"~     Stroke is the second cause of death worldwide and the majority of the survivors remain with~     motor impairments. Inhibition of the motor cortex of the unaffected hemisphere has emerged as~     a potential intervention to enhance effects of other rehabilitation strategies on improvement~     of motor performance of the paretic upper limb. In this proof-of-concept study we will~     evaluate the effects of inhibition of the motor cortex of the unaffected hemisphere~     associated with robotic therapy on improvement of motor performance of the paretic upper limb~     in the early phase post-stroke.~   "
25688|NCT03230682|"~     Early improvemrnt, decreased 20% in the 17 items of Hamilton Depression Rating Scale~     (HAMD-17) at the second week of the treatment of major depression disorder (MDD), can~     arguably predict the remission at the 12th week. Our observation study including 80 MDD~     patients will access resting-state function MRI to finding factors which infuencing early~     improvemrnt, respone and remission of antidepressants.~   "
25689|NCT03230669|"~     Computer-based Training for Cognitive Behavioural Therapy (CBT4CBT) is a new on-line~     addiction treatment developed by Dr Kathleen Carroll at the Yale School of Medicine in New~     Haven, Connecticut. CBT4CBT consists of seven one-hour long online sessions that teach key~     concepts, including dealing with cravings, problem solving, and decision making skills, to~     help users reduce substance abuse. CBT4CBT has been rigorously tested throughout various~     communities in the United States with great success and is currently being rolled out~     throughout the States. The therapeutic approach of CBT4CBT is unique as its efficacy,~     durability and cost-savings have been proven in several rigorous clinical trials and will be~     magnified by the fact that the program can be delivered in Canada, allowing for increased and~     continual improvements in population health. CBT4CBT has been accepted by both patients and~     addiction treatment personnel alike and has won numerous clinical innovation awards.~      A collaboration has now been formed between Dr Carroll and Drs Michelle Patterson and Juergen~     Krause of the UPEI Centre for Health and Community Research (CHCR) that will bring CBT4CBT to~     Canada. While CBT4CBT has previously been tested in urban areas, there are many advantages to~     offering computer-based training to more rural populations (such as PEI). These more remote~     areas frequently suffer from a lack of services, as well as a lack of continuity with the~     services currently offered. CBT4CBT may very well provide that needed continuity to~     Addictions treatment and has also been shown to improve retention.~   "
25690|NCT03230656|"~     Approximately 15-20% of patients diagnosed with a concussion/mild traumatic brain injury~     (mTBI) have persistent symptoms that continue up to six months or longer. Typical problems~     identified by these patients include difficulty with memory, multi-tasking, the ability to~     complete tasks quickly, and higher executive functions (e.g., inhibition, initiation,~     insight, motivation) (Belanger & Vanderploeg, 2005; Mott, McConnon, & Rieger, 2012,~     Rabinowitz & Levin, 2014). If these symptoms persist they can not only affect thinking, but~     also communication abilities (e.g., verbal and nonverbal interactions, reading, and writing)~     (ASHA, 2007). Therefore, it is hypothesized that screening measures that evaluate both~     thinking and communication can better identify individuals at-risk for persistent symptoms at~     two week and four weeks post-injury. Also, if cognitive-communication therapy was~     administered earlier post-injury, then outcomes related to return to daily activities, work,~     and/or the academic setting could possibly change. This study intends to investigate the use~     of cognitive and communication screening measures for the identification of persistent~     symptoms and the provision of early cognitive-communication therapy if problems persist.~   "
25691|NCT03230643|"~     The objective of this single center prospective clinical trial is to evaluate the safety and~     efficacy of carotid Baroreflex Activation Therapy (BAT) in advanced heart failure (HFrEF).~     Beyond that, the primary aim of this study is to identify patients of the whole HFrEF~     population that are most likely to benefit from this new promising therapy.~   "
25693|NCT03230617|"~     Chronic obstructive pulmonary disease is a common respiratory condition that is characterized~     by inflammation of the large and small peripheral airways , the alveoli and adjacent~     capillary networks. Severe airflow obstruction that imposes a significant load on the~     respiratory system is a major manifestation of Chronic obstructive pulmonary disease. The~     reduced expiratory airflow also causes air trapping at the end of expiration , producing~     alveolar pressure that are higher than atmospheric pressure before the next breath. This~     condition is intrinsic positive end-expiratory pressure .~   "
25694|NCT03230604|"~     To minimize the effects of polymerization shrinkage in the restorative treatment, there are~     new composites called Bulk- Fill which the companies has developed this composites for~     example Tetric N Ceram(Ivoclar-Vivadent) and Filtek ( 3M ESPE). Its decreased polymerization~     shrinkage and properties allow the material to be inserted in one layer being quickly than~     traditional composite. This clinical study is designed to compare the clinical performance of~     the bulk fill composite resin in Class I (one-surface posterior), II (two-surface posterior)~     and V (cervical-surface posterior) fillings.~   "
25695|NCT03230591|"~     Study Design: This is an observational study. No treatment or intervention will be assigned~     to the subjects. All patients will receive full standard of care concomitant medication for~     the treatment of their cardiac condition. 25 patients with genetically confirmed~     Anderson-Fabry disease who have a plan to start ERT with Agalsidase Alfa will undergo 2D~     strain, diastolic stress echocardiography, LV vortex flow analysis, and CMR at baseline and~     after 1 year of treatment with ERT with Agalsidase Alfa for follow-up.~   "
25696|NCT03230578|"~     The goal of this study is to identify the thoughts and perceptions of pharmacy access to~     hormonal contraception among rural women and pharmacists. This will be key in order to~     address concerns or perceived barriers in order to inform the implementation of this program.~   "
25697|NCT03230565|"~     To compare continuous infusions to bolus infusions and there affect on post-surgical pain.~   "
25698|NCT03230552|"~     There is a need for the development and validation of new teaching strategies and resources~     for surgical training that can occur outside of the operating room. The use of surgical~     videos is not novel however it has not been validated as an effective approach for~     gynecologic surgical training. The goals of our study are to (1) develop an educational~     surgical video for laparoscopic salpingo-oophrectomy (LSO) and (2) to evaluate and test the~     effectiveness of this tool in preparing residents for performance in the operating room.~   "
25699|NCT03230539|"~     The UPA doses to be tested in this new IUS, 5, 20 or 40 μg per day, are not expected to~     suppress ovulation, however they should prevent endometrial growth resulting in endometrial~     atrophy, minimal bleeding, or even amenorrhea. It is anticipated that with low UPA doses,~     women will continue to ovulate and secrete progesterone (P) during the secretory phase of the~     menstrual cycle. As a result, PRM associated endometrial changes (PAECs) that have been~     described in previous UPA studies when ovulation was suppressed and associated with~     amenorrhea should not occur and endometria should retain normalcy. These expectations are~     based on our findings from a previous study in which the UPA doses tested were insufficient~     to block ovulation and participants maintained P secretion with normal endometria (protocol~     349). Further evidence regarding the benefit of using low doses of UPA in a copper IUS stems~     from a small rhesus macaque proof of principle study that included an UPA-IUS delivering 40~     or 60 μg/d of UPA, and fixed doses of E2 and cyclic P delivered via implants over 3 cycles.24~     Indices of endometrial proliferation were significantly reduced in 3 out of 5 animals in that~     study; the endometria were atrophied with some glandular cysts, and typical PAECs were~     limited. Glands were generally small and tubular, however, in some animals they were large~     and dilated; resembling cysts with minimal evidence of proliferative activity.24 No bleeding~     was observed in the treated monkeys during progesterone withdrawal over the 3 cycles.~   "
25700|NCT03230526|"~     Phase II, Open-labeled, Prospective, Multi-center study of assessing the link between~     microglial activation and dopaminergic denervation kinetics in the early stage of Parkinson~     disease, by using the imaging of [18F]DPA-714 a new ligand of Translocator Protein-18 kDa~     (TSPO) by Positron Emission Tomography (PET).~   "
25701|NCT03230513|"~     Benign paroxysmal positional vertigo (BPPV) is the most common vestibular disorder in adults~     and the treatment of choice is by particle repositioning manoeuvres (PRM). This study aims to~     compare the treatment efficacy of two home-based exercises, self-Epley manoeuvre (SEM) and~     Brandt-Daroff exercise (BDE) in patients with posterior canal BPPV based on vertigo~     resolution, reduction of vertigo intensity, the Dizziness Handicap Inventory scores and the~     conversion of a positive to negative Dix-Hallpike test.~   "
25702|NCT03230500|"~     Patients with remaining root or fractured teeth indicated for extraction in the esthetic zone~     will be recruited to the study. After extraction of the tooth implant will be placed~     immediately, implants will be placed either by free hand or computer guided technique.~     patient satisfaction will be evaluated as primary outcome and early implant failure will be~     evaluated as secondary outcome.~   "
25703|NCT03230487|"~     Part 1 (SRD (Single-rising dose)):~      The primary objective of this trial part is to investigate the safety and tolerability of BI~     1015550 in healthy male subjects following oral administration of single rising doses.~      Secondary objectives are the exploration of the pharmacokinetics of BI 1015550 after single~     dosing.~      Part 2 (MRD (Multiple-rising dose)):~      In Part 2, the primary objective is to investigate the safety and tolerability of BI 1015550~     in healthy male subjects following oral administration of multiple rising doses.~      Secondary objectives are the exploration of the pharmacokinetics of BI 1015550 after multiple~     dosing.~   "
25704|NCT03230474|"~     I.V naloxone decreases incidence and severity of the common morphine side effects (pruritis,~     nausea/emesis, constipation, urinary retention, respiratory depression and undesirable~     sedation) so using it as additive to intrathecal morphine in patients undergoing anal~     surgeries under spinal anesthesia may be beneficail~   "
25705|NCT03230461|"~     Optimal chest compression depth during CPR is 4.56cm which is at variance with the current~     guidelines of 5.0-6.0cm. A change in guidelines is only worthwhile if healthcare~     professionals can accurately judge a subtle reduction in chest compression depth during CPR~     by a relatively small amount.~   "
29023|NCT03187106|"~     The purpose of this study is to determine if the addition of a 48-hour course of~     post-operative antibiotics to the recommended course of pre-operative antibiotics improves~     surgical site infection rate in patients who are obese and undergo Cesarean section after~     laboring.~   "
25707|NCT03230435|"~     Eating disorders (ED) comprise a multitude of symptoms involving a disturbed body image and a~     preoccupation with food or bodyweight. EDs are often difficult to treat, in part due to the~     lack of motivation for improvement. Anorexia nervosa (AN) has the highest mortality rate of~     any psychiatric disease, and less than half of patients will recover from the disease.~     Studies have found that patients suffering from AN have impaired health-related quality of~     life (HRQoL) compared to the general population. It has also been suggested that despite~     improvement in clinical parameters, patients report deterioration in HRQoL, which is in line~     with a study finding low agreement between patient perceived outcome and clinician assessed~     characteristics. To evaluate the patients' perception of their disease, it is important to~     develop reliable and valid assessment tools. Previously generic questionnaires have been used~     to assess HRQoL in Danish ED patients, as no disease-specific questionnaires have been~     developed. Translating and validating a disease-specific questionnaire would provide a useful~     tool in assessing current treatment and in developing new treatment options. This study aimed~     to develop a Danish version of an internationally disease-specific HRQoL questionnaire.~     Furthermore, HRQoL is assessed in patients who have gone through shorter or longer treatment.~   "
25708|NCT03230422|"~     In Pediatric both manikin and human studies have suggested that the video laryngoscopy is~     equally suitable to facilitate intubation compared to the direct laryngoscopy.~   "
25709|NCT03230409|"~     This study evaluates the efficacy of nursing interventions on adherence to antituberculosis~     medication in a paediatric cohort (aged 0-18 years) and identifies the risk factors for~     non-compliance.~      There are two phases in the study; Phase 1: retrospective descriptive analysis in children~     and young people receiving antituberculosis treatment (non-intervention group); and Phase 2:~     quasi-experimental, longitudinal, prospective study (intervention group). The results of the~     two phases will be compared.~   "
25710|NCT03230396|"~     The present study will investigate the oral release and systemic pharmacokinetics of a panel~     water- and fat-soluble vitamins from two commercially-produced chewing gum formulations.~     Vitaball, Inc. (Ft. Thomas, KY) markets a line of vitamin-fortified gums. These products~     include Vitamingum Sport and Vitamingum Fresh, which are marketed to different consumer~     populations. There is currently no available data on the release of vitamins from these~     products in the oral cavity or the impact of chewing these products on plasma levels of the~     component vitamins following acute administration. The investigators hypothesize that these~     chewing gum products will increase both salivary and plasma levels of the component vitamins.~     The present study has two major objectives:~        1. To determine the extent to which a subset of water-soluble and fat-soluble vitamins in~          two different Vitamingum products are released from the gum matrix and into the saliva~          as healthy human subjects chew the gum.~        2. To determine the extent to which chewing Vitamingum can acutely influence plasma levels~          of a subset of water-soluble and fat-soluble vitamins in a population of healthy human~          subjects.~      The test articles are commercially-marketed products and are currently available to~     participants outside the study (http://chewvitamingum.com). The present study is not intended~     to develop a treatment for a particular disease, but rather to determine if the vitamin~     components of these commercially-produced chewing gum products are bioaccessible or~     bioavailable. Vitamin supplements administered as tablets, capsules, caplets, or gummies~     might be regarded as the standard of care.~   "
25711|NCT03230383|"~     This will be an investigator- and subject-blinded (sponsor open), randomized, placebo~     controlled, sequential, ascending, multiple oral dose study, with 5 planned cohorts (optional~     sixth and seventh cohorts). A total of approximately 50 (if 5 cohorts), 60 (if 6 cohorts),~     and up to 70 (if 7 cohorts) subjects will be randomized in this study. Subjects in each~     cohort will be randomized to receive PF-06865571 or matching placebo with approximately 10~     subjects dosed in each cohort.~      For a given subject in any cohort, the total study duration from screening to follow-up phone~     call will be between approximately 7 to 11 weeks.~   "
25712|NCT03230370|"~     Study purpose This study will explore whether an additional rehabilitation program that focus~     on either upper or lower extremity training facilitate the recovery in upper or lower~     extremity.~      The recovery in both neurological status and motor functions will be explored.~   "
25713|NCT03230357|"~     This study is a multi-center clinical study, 3000 cases, 25 centers in the country involved,~     carry out the guidance of EDUG PICC standardized operation at the same period. Each center~     assists to use app to collect research data.The experimental data will be collected,~     processed and analyzed by the sponsor and the researchers, and the clinical effect of EDUG~     will be evaluated according to the results (like the rate of once in place, the number of~     adjustment times before X-ray, the length of time during the whole catheter placement, the~     ectopic incidence during PICC first implantation and so on, the special content can be seen~     in the next indicator section)~   "
25714|NCT03230344|"~     The aim of this study is to evaluate the periodontal parameters in terms of periodontal~     healing by periodontal surgical therapy with simultaneous or delayed endodontic therapy in~     management of concurrent endodontic -periodontal lesion without communication~   "
25715|NCT03230331|"~     This study aims to evaluate the long term effect of deep brain stimulation in the the~     subthalamic nucleus (STN) in patients with Parkinson's disease.~   "
25716|NCT03230318|"~     This pivotal, open-label, single-arm study will evaluate the anti-cancer activity of ARQ 087~     by Objective Response Rate (ORR) by central radiology review as per RECIST v1.1 in subjects~     with inoperable or advanced intrahepatic cholangiocarcinoma (iCCA) whose tumors harbor FGFR2~     gene fusions (by FISH performed by the central laboratory) and who received at least one~     prior regimen of systemic therapy. Subjects will be dosed orally once per day at 300 mg of~     ARQ 087 capsules.~   "
25758|NCT03229772|"~     The primary purpose of the study is to obtain sample clinical images that are evaluated by~     physicians in support of regulatory submissions. Additionally, the study will provide data~     for current and future product development and it will provide clinical images and data for~     marketing use.~   "
25759|NCT03229759|"~     Healthy volunteers will receive treatment to two body locations with the investigational~     product and placebo and the antimicrobial effectiveness of each treatment will be measured.~   "
30317|NCT03170219|"~     To determine if a strategy of early discharge using a novel subcutaneous delivery system for~     parenteral furosemide can improve clinical outcomes within 30 days of randomization (days~     alive and outside the hospital) compared to usual care.~   "
25717|NCT03230305|"~     The transposition of the results of biomedical research to medical management of patients in~     real-life setting depends highly from patient's selection. In Europe and the United States,~     the majority of cancers occur after 65 years. In France, 45% of cancers diagnosed in 2012~     were after 70 years or 158,722 in absolute value. In this context, the median age at~     diagnosis was 72 years old. Disease particularly affecting the elderly, cancer is also~     characterized by the importance of biomedical research devoted to it. Despite the dynamism of~     the research activity in oncology and therefore the number of affected patients, the elderly~     are paradoxically sparsely included in clinical trials. Numerous studies have focused in~     recent years, to identify possible causes of under-representation of elderly patients in~     clinical trials but most of them focused on eligibility criteria and few on barriers related~     to non-invitation or non-inclusion in eligible patients.~      We postulate that a qualitative survey based on an structured epidemiological device will~     able to objective evidences of reasons related to the patient, his/her familial caregivers,~     his/her physician and the clinical center organization for participating or not to a clinical~     trial and the interrelations between the identified reasons.~      The main objective is to assess reasons of non-participation of older patients with cancer in~     clinical trials, from the physicians, patients and family caregivers' perspectives using~     qualitative and quantitative methods.~      The secondary objectives are:~      To investigate the social representation and construction of being aged from the patient,~     physician and family caregiver perspective (qualitative part).~      To compare the reasons of non-participation regarding age class (old and very old), localized~     versus metastatic disease and tumor site (quantitative part).~      To characterize the profiles of participants and non-participants to clinical trial among~     older patients with cancer thanks to qualitative and quantitative data.~      Method Quali SAGE is a French, socio-epidemiologic, multicenter prospective study that~     includes patients aged 70 years or over, with solid tumor (irrespective of the stage) in~     French hospitals.~   "
25718|NCT03230292|"~     This is a study to assess the long-term safety, tolerability, and efficacy of bimekizumab.~   "
25719|NCT03230279|"~     Patients diagnosed with chronic SIJ pain that can be treated by sacroiliac joint fusion or~     radiofrequency ablation. The radio frequency ablation is performed using either conventional~     or cooled techniques aimed at the S1-S3 lateral branches and the L5 dorsal ramus. Minimally~     invasive sacroiliac joint consists of implanting 2 to 3 metallic implants inside the SIJ to~     increase the stability and eventually fuse the SIJ. This randomized controlled trial aims at~     comparing treatment success at 6-month follow-up time-point after minimally invasive~     sacroiliac joint fusion and radiofrequency ablation for chronic SIJ dysfunction.~   "
25720|NCT03230266|"~     During this study, the investigators will perform a collection of biological and device~     samples (blood, catheters, insulin) in order to investigate the causes of catheter~     obstructions in patients with type 1 diabetes treated by implanted insulin pumps using~     intra-peritoneal delivery.~      This multi-centre study is interventional with minimal constraints. After an inclusion visit,~     blood samples and an insulin sample from pump reservoir will be collected. During the~     following year, if a peritoneal catheter is blocked or changed, the explanted catheter and~     new blood and insulin samples will be collected for examination of the catheter obstruction~     and search for patient- or insulin-related reasons for obstructions.~      In this study, 140 patients will be investigated.~   "
25721|NCT03230253|"~     The purposes are to: (1) examine and compare the effects of two hybrid interventions on brain~     plasticity, physiological biomarkers and behavioral outcomes, including cognitive and~     physical functions, from pre- to post-training; (2) understand the neural mechanisms of~     cognitive recovery following two hybrid interventions using the functional magnetic resonance~     imaging (fMRI); (3) examine the long-term benefits of the two hybrid therapies; (4) to~     identify the correlations between brain activity, biomarkers and behavioral measures.~   "
25722|NCT03230240|"~     To ascertain immunologic profile of peritoneal cavity and its relationship to immediate~     postsurgical outcome (morbidity or the treatment) and long-term outcome (time to recurrence~     and survival).~   "
25723|NCT03230227|"~     Effective pain relief after cardiac surgery has assumed importance with the introduction of~     fast track discharge protocols that requires early weaning from mechanical ventilation.~     Inadequate pain control reduces the capacity to cough, mobility, increases the frequency of~     atelectasis, and prolongs recovery. Infiltration of local anesthetics near the surgical wound~     has shown to improve early postoperative pain in various surgical procedures.~      Magnesium is the fourth most plentiful cation in our body. It has antinociceptive effects in~     animal and human models of pain.~   "
25724|NCT03230214|"~     The present study is to demonstrate the effect of the presence of bacterial translocation~     detected by bacterial deoxyribonucleic acid (bactDNA) in blood and ascites using the~     polymerase chain reaction (PCR) on some haemodynamic and coagulation parameters during a~     liver transplant procedure.~   "
25725|NCT03230201|"~     This clinical trial is designed to evaluate the role of lymph node dissection in the~     prevention of recurrence and metastasis after radical nephroureterectomy for high-risk~     primary upper tract urothelial carcinoma (UTUC) patients.~   "
25726|NCT03230188|"~     The overall purpose of the study is to compare the patterns of neurocircuitry activation in~     severe asthmatics vs. mild to moderate and healthy controls. The Investigators hypothesize~     that neurocircuitry activation increases with asthma severity, producing different~     neurocircuitry patterns for severe asthmatics than those of mild to moderate asthmatics or~     non-asthmatics.~   "
25727|NCT03230175|"~     It is hypothesized that application of the human placental umbilical cord tissue TTAX01 to~     the surface of a well debrided, complex diabetic foot ulcer will, with concomitant management~     of infection, result in a higher proportion of wounds showing complete healing within 16~     weeks of initiating therapy.~   "
25728|NCT03230162|"~     comparing the effect of using sildenafil citrate and LMWH in treatment of cases of IUGR due~     to placental insufficiency~   "
25729|NCT03230149|"~     FD is pan-ethnic. Its reported annual incidence of 1 in 100,000 may underestimate the true~     prevalence of the disease. Indeed, recently, in addition with affected males FD developing a~     classic phenotype,  cardiac variant  and  renal variant  have been reported for FD~     patients with predominant or exclusive cardiac or renal involvement.  Neurologic variant ~     could exist.~      Nervous system can be affect by FD leading to cerebrovascular diseases (ischemic or~     haemorrhagic strokes, TIA (Transient Ischemic Attacks) or peripheral neuropathy~     (acroparesthesias and pain).~      Aims will be to determine the prevalence of Fabry disease in patients with stroke or small~     fiber neuropathy, and their characteristics~   "
25730|NCT03230136|"~     This trial investigates whether a multimodal cardioprotection per-surgery therapeutic~     strategy could reduce myocardial injury in patients undergoing cardiac surgery compared to~     traditional management. The primary endpoint is the AUC (area under the curve) of the~     hypersensitive troponin I. Blood samples will be collected during the 72 hours following the~     aortic cross-unclamping. This trial is a French, multicenter, randomized, single-blinded and~     controlled trial. 210 patients will be enrolled with a clinical follow-up during 30 days.~   "
25731|NCT03230123|"~     Costa ES, Izar MC, Fonseca FAH, França C, Tria H. The benefits of green banana biomass~     consumption in patients with diabetes mellitus. Federal University of São Paulo, São Paulo,~     2015.~      According to the Guidelines of the Brazilian Society of Diabetes, Diabetes Mellitus (DM) is a~     heterogeneous group of metabolic disorders associated with microvascular complications,~     hyperglycemia, resulting in a higher risk of developing cardiovascular disease. Currently, it~     is estimated that the world population with diabetes is 382 million people and it is expected~     to reach 471 million in 2035. About 80% of individuals with diabetes live in developing~     countries where the epidemic has greater intensity. In the Diabetes Control and Complications~     Trial and UK Prospective Diabetes Study demonstrated that intensive glycemic control (HbA1c ~~     7.0%) reduces chronic microvascular complications. The resistant starch (RS) is defined as~     starch and products of its hydrolysis are not absorbed in the small intestine. The green~     banana presents significant levels of RS, and it is considered a source for the intake of~     this substance. These foods have physiological functions in the intestinal regulation in~     glycemic control and delayed gastric emptying. To our knowledge, there are no long-term~     studies with DM to prove the benefits of resistant starch use. The objective of this study is~     to assess the benefits of green banana biomass consumption by patients with Pre DM and DM.~     Considering the possibility of improving glucose, lipid profile, increasing the secretion of~     glucagon-like peptide-1 (GLP-1), insulin, adiponectin, and reduction in inflammatory markers~     IL-6, PCR.~   "
25732|NCT03230110|"~     The purpose of this study is to identify whether pregnant women with chronic hypertension are~     at significantly higher risk of having undiagnosed OSA and should be routinely screened with~     home sleep tests. The investigators will recruit 120 pregnant subjects between 10-20 weeks~     gestation from the Duke High Risk Obstetrics Clinic over a 20-month period. They will be~     enrolled into one of two groups: 1) chronic hypertension (on medication or hypertensive blood~     pressures documented at 3 clinic visits); 2) normal blood pressure, and not on any treatment~     for chronic HTN and no history of chronic HTN, and matched for BMI (+/- 3 kg/m2) with the~     chronic HTN group. The two groups will be matched for BMI to control for the effect of~     obesity on OSA diagnosis and cHTN. The primary hypothesis, that OSA prevalence differs~     between patients with chronic HTN and normotensive controls, will be assessed with a~     two-group two-sided Fisher's exact test. A Fisher's exact test with a 0.05 two-sided~     significance level will have 92% power to detect the difference between a normotensive OSA~     rate of 0.10 and a chronic hypertensive OSA rate of 0.40 when the sample size in each group~     is 50. There are no risks associated with the use of the home sleep test device, but subjects~     that have a severe latex allergy should not participate, as the device~   "
25733|NCT03230097|"~     To investigate the efficacy, safety and tolerability of BI 409306 once daily compared to~     placebo given for 52 weeks to subjects with attenuated psychosis syndrome.~   "
25734|NCT03230084|"~     Infertility affects many people in Ontario and carries a significant amount of emotional,~     physical and financial burden to those who experience it. Knowing when a woman ovulates is~     important for improving a couple's chance to become pregnant naturally and for learning about~     fertility problems, such as infertility, irregular menses, and hormonal disorders.~      Currently, there are two reliable methods to confirm ovulation: a trans-vaginal ultrasound or~     a blood test for progesterone, which is a hormone that only rises sharply after ovulation.~     However, both are time consuming and expensive. Recently, an inexpensive, home-based urine~     test strip has been developed to confirm ovulation. The test strip works by measuring urine~     for a marker of Progesterone, called pregnanediol-3a-glucuronide (PDG).~      The purpose of this feasibility study is to follow the use of this home-based PDG urinary~     test strip over the course of one menstrual cycle in 25 female participants. The results of~     the urine test strip will then be compared to a Progesterone blood test. Participants will be~     recruited from the general Ottawa, Ontario area The ultimate aim of this study is to provide~     information for the design of a larger study to determine the accuracy of the PDG urinary~     test strip. If shown to be as effective in confirming ovulation, this test would provide~     substantial cost saving to the Ontario health care system and a much more convenient way for~     women and clinicians to confirm ovulation and determine if women are fertile.~   "
25735|NCT03230071|"~     The study will be a 24-week multicentre, double-blind, placebo-controlled phase Ⅱa trial with~     4 treatment arms in China. Participants aged 55-80 years will be randomized to TMBCZG-high~     dose(84mg per day), TMBCZG- medium dose(56mg per day), TMBCZG- low dose(28mg per day) or to~     placebo. The primary endpoint will be VADAS-Cog and CDR-SB. Secondary outcomes included~     changes in MMSE and ADL. Patients' safety will be assessed by recording of adverse events,~     clinical examinations, electrocardiography and laboratory tests. The patients, caregivers,~     and investigators will be blinded to the treatment allocations.~   "
25736|NCT03230058|"~     OBJECTIVE To evaluate the efficacy and safety of the concurrent treatment of 5% Natamycin and~     1% Voriconazole in patients affected by fungal keratitis METHODS AND MATERIALS STUDY~     POPULATION Patients with smear and or culture proven fungal keratitis presenting to our~     Instituts, were eligible for enrollment.~      STUDY DESIGN Prospective double masked randomized clinical trial.~   "
25737|NCT03230045|"~     Stimulation at acupoints could be of beneficial effects during the perioperative period. In~     this study the investigators tend to verify the effect of dual acupoints stimulation on~     pulmonary complications after abdominal surgery in aged patients.~   "
25738|NCT03230032|"~     The study seeks to determine the efficacy of non-nutritive suck (NNS) training using a~     pacifier-activated device (PAM) with mothers' voice to condition suck-strength and~     rhythmicity, in improving the feeding and developmental outcomes of infants at high-risk for~     CP.~   "
25739|NCT03230019|"~     This study evaluates the viability and safety of two-lumen catheterization versus chest tube~     placement in patients with lung wedge resection. Half of participants will receive routine~     chest tube placement, while the other half will receive a two-lumen central venous~     catheterization along the midclavicular line, second intercostal space for remedial~     gas-remove.~   "
25845|NCT03228641|"~     A pilot study is designed to evaluate safety and efficacy of the Micro-Coring (MC) technology~     for treatment of facial wrinkles. MC device employs hollow coring needles that enable safe,~     rapid, and effective full-thickness small skin cores (200-500 microns in diameter) removal~     initiating a skin repair process through formation of new collagen and elastin fibers (skin~     rejuvenation).~   "
25740|NCT03230006|"~     Almost 18 million US adults have alcohol use disorders (AUD), with one third of these~     individuals also diagnosed with anxiety disorders (AXD). The coexistence of AUD and AXD~     imposes a high burden via healthcare costs and lost productivity. To date, existing treatment~     approaches for addressing AUD/AXD comorbidity have been only modestly effective and there is~     a lack of adequate research to guide treatment decisions.~      The Unified Protocol (UP) is a transdiagnostic, cognitive-behavioral therapy that has shown~     efficacy in treating emotional disorders. The efficacy of the UP to facilitate abstinence~     from alcohol consumption in individuals with comorbid AUD/AXD has also been examined, with~     results from this study indicating a reduction from baseline in drinks consumed per day.~     However, further evaluation of the UP for managing AUD/AXD is warranted.~      In this clinical trial, the investigators will further assess the UP's effectiveness in~     reducing alcohol consumption in patients with comorbid AUD/AXD. Participants will be~     randomized to one of two conditions: 1) treatment with the UP or 2) treatment with~     therapist-guided Take Control (TC; a computerized alcohol reduction program). In addition, in~     a subset of twenty-five participants, functional magnetic resonance scanning (fMRI) will be~     used to examine the effects of the UP on changes in brain activity in areas important to~     regulation of emotional and reward processes implicated in excessive alcohol consumption.~      The researchers' primary hypotheses are that the UP group will, compared to the TC group: 1)~     be superior in acute symptom reduction from pre- to post-treatment, and 2) evidence greater~     reductions in percent days heavy drinking, percent days of drinking per week, and alcohol~     craving.~   "
25741|NCT03229993|"~     To find out the safety and efficacy of Optical Coherence Tomography (OCT) in the evaluation~     and treatment of angiographically borderline coronary artery lesions in a Chinese population,~     and to compare the effectiveness of OCT versus SPECT in treating such subjects. All the~     participants included in the study will be those that are found to have borderline coronary~     artery lesions on coronary angiography, in whom the investigators feel that OCT will be~     useful to assess whether PCI will be of benefit to the treatment of the lesion pathology, or~     whether optimal medical therapy is the most appropriate treatment modality. Those~     participants who declined OCT will be offered SPECT as an alternative method to assess and~     treat the borderline coronary artery stenosis.~      It is estimated that OCT guided PCI or not has a non-inferiority to SPECT's in the~     borderline coronary artery stenosis.~   "
25742|NCT03229980|"~     The advances in cardiac surgery and anesthesia for pediatric patients planned for repair of~     congenital heart disease encourage us to discuss problems that occur during this surgery~     especially during Cardiopulmonary Bypass (CPB). Cardiopulmonary Bypass induces a damaging~     systemic inflammatory response, in addition to a myocardial ischemia-reperfusion injury (IRI)~     as a result of cessation and re-initiation of coronary artery circulation~   "
25743|NCT03229967|"~     The purpose of this study is to advance our knowledge of the factors that contribute to the~     development of bronchopulmonary dysplasia (BPD), a chronic lung affecting premature infants.~     Specifically, the investigators will determine the complexity of the gut microbiota, the~     genera of the bacteria that naturally live in the gut, and determine if the relative~     diversity of the gut bacteria is a prognostic indicator of BPD. To accomplish this, the~     investigators propose to characterize the microbiota of human premature newborns with BPD,~     then validate this potential mechanism in mice. The investigators will enroll very low~     birthweight premature infants admitted to the neonatal intensive care units (NICU) at Le~     Bonheur Children's Hospital and Regional One Health that are at high risk to develop BPD. A~     cohort of well full term newborns may also be enrolled. Non-invasive stool samples will be~     obtained weekly over the first month of life. Infants that eventually develop BPD will be~     paired with infants that did not develop BPD. Stool samples from these infants will be sent~     for analysis. The investigators expect that reduced complexity of the gut microbiome is~     associated with BPD. The investigators will model the contribution of reduced microbiome~     complexity to the risk to develop BPD or death, as well as the association with disease~     severity. A companion study is also being conducted by the investigators exploring the~     mechanism using mice. The project investigates important factors leading to the development~     of BPD, and has the potential to directly translate to therapy for the most significant~     pulmonary complication of prematurity.~   "
25744|NCT03229954|"~     Iron deficiency anemia is a common complication in patients who underwent gastrectomy and~     leads to a deterioration in patient's quality of life. Therefore iron supplementation is one~     of the important treatments in postgastrectomy patients.~      Taking an oral iron is an option for iron supplementation, but the postgastrectomy patients~     has poor absorption of iron due to their anatomic change. Accordingly, intravenous iron~     supplementation has been emerged as another treatment option, but there are only a few~     studies to evaluate the efficacy of intravenous iron supplementation compared with oral iron~     in patients underwent gastrectomy.~      Therefore, this study aims to evaluate the iron supplementation method as intravenous~     injection of iron isomaltoside compared with oral iron in the treatment of postgastrectomy~     anemia.~      Gastric cancer patients who underwent curative gastrectomy more than 1 year ago and~     hemoglobin level lower than 11 g/dL will be included in this trial. After the registration,~     the patients will be randomly assigned to intravenous iron (n = 179) or oral iron groups (n =~     179).~      Calculated dose of iron isomaltoside using Ganzoni formula will be injected intravenously in~     intravenous iron group and 160 mg/day of ferrous sulfate for 12 weeks will be taken in oral~     iron group. Hemoglobin and iron profiles at baseline and weeks 2, 4, 8, and 12 and quality of~     life score at baseline and weeks 12 period will be evaluated.~   "
25745|NCT03229941|"~     The goal of the proposed study is to determine whether a liberal transfusion strategy~     (transfusion trigger at Hb < 10 gm/dl) in Veterans at high cardiac risk who undergo major~     open vascular and general surgery operations is associated with decreased risk of adverse~     postoperative outcomes compared to a restrictive transfusion strategy (transfusion trigger at~     Hb < 7 gm/dl).~   "
25760|NCT03229746|"~     Hydroxychloroquine has been reported to have a clinically significant effect on the platelet~     count in systemic lupus thrombocytopenia. Its action may be due to its immune modulator~     effect. Immune thrombocytopenia (ITP) is known as an immune-mediated acquired disease~     characterized by transient or persistent decrease of the platelet count. However, refractory~     ITP is lacking of effective treatments and the efficacy of decitabine in ITP remains poorly~     understood. Data from this study may provide some idea of Hydroxychloroquine in the treatment~     of ITP in comparison to other lines of treatment as detected by the standardized definitions.~   "
25746|NCT03229928|"~     The efficacy of clinical trials addressing behavioral issues in individuals with~     intellectual/developmental disabilities (IDD) has traditionally been hampered by lack of~     objective and sensitive measures. While there are many behavioral observation measures~     available, most of them either rely on recall of the event or are designed for use by trained~     professional observers, requiring a third party or extensive training for use. The Measuring~     Outcomes for CHange (MOCHA) phone based application was developed to address the need for~     feasible real-time tracking of behavior. For the current study, 2 parents of children with~     IDD, 2 special education teachers, and 2 behavior health professionals will be recruited to~     serve on a stakeholder advisory panel. These individuals will provide initial feedback on the~     use of the application. Primary participants will be the parents and teachers of 10 children~     or adolescents (age 5-17 years) who are seeking treatment and support for the child's~     challenging behaviors (aggression, self-injurious behaviors, severe irritability) from~     clinicians in the Behavior Medicine Clinic at the Carolina Institute for Developmental~     Disabilities. Participants in the study will use MOCHA to record the child's behavior each~     time it occurs over 6 weeks in order to test the feasibility of using MOCHA over time and in~     response to treatment. The first 2 weeks of data collection will occur prior to the~     participant's scheduled visit to the BMC. Following the clinic visit, where clinically~     determined treatment suggestions will be provided, participants will continue to collect data~     for 4 weeks to determine if long term data collection is feasible and if change can be~     detected in response to the treatment through MOCHA (and compared to pen and paper~     questionnaires). Two children will be chosen from this participant pool to wear a sensor~     device to determine feasibility of syncing wearable sensors with the MOCHA app for use in~     future research studies. Following the 6 weeks of MOCHA use, all participants will receive a~     call or in person visit to conduct an exit interview about the participant's experiences~     using MOCHA. The overall goal of this study is to determine the feasibility of the use of the~     MOCHA application to track behaviors in populations of children with IDD. The MOCHA app does~     not act as an intervention and is not modifying the environment of the participants, but will~     be used as a tool by caregivers to track behaviors in real time.~   "
25747|NCT03229915|"~     Posttraumatic stress disorder (PTSD) is prevalent mental illness (~9% life-time) that results~     from exposure to trauma. As it is associated with vastly heterogeneous origins, accurate~     diagnosis and optimal treatment strategies are sometimes very difficult to achieve. No known~     biomarker exists, which makes it difficult to assess treatment response and functional~     outcomes. The recent brain imaging studies have suggested that PTSD patients show abnormal~     brain connectivity measured by functional magnetic resonance imaging (fMRI). The~     investigators propose that cognitive processing therapy may ameliorate this functional~     connectivity abnormality which may be related with their symptomatic improvement.~   "
25748|NCT03229902|"~     There is an evidence gap on whether meditation may improve behaviorally measured attention~     after stroke, but preliminary research is promising. This study is the first-ever~     investigation of whether mantra meditation may improve chronic, severe impairment in~     attention after stroke.~   "
25749|NCT03229889|"~     Extensive literature exists on the use of alpha-blocker medications for the removal of kidney~     stones. Alpha blockers relax certain muscles and help small blood vessels remain open. They~     work by keeping the hormone norepinephrine (noradrenaline) from tightening the muscles in the~     walls of smaller arteries and veins, which causes the vessels to remain open and relaxed.~     This improves blood flow and lowers blood pressure. There are studies that demonstrate~     alpha-blockers decrease ureteral pressure and help the ureter relax.~      Recent studies have shown that phosphodiesterase inhibitors may also help with ureteral stone~     passing. A phosphodiesterase inhibitor is a drug that blocks an enzyme that inhibits~     relaxation of smooth muscle. This means that it can help smooth muscle, such as the muscle~     that lines the ureter, to relax. While ureteral relaxation is helpful in the passage of~     ureteral stones, our study seeks to use this finding by pretreating participants with an~     older generation alpha blocker or a phosphodiesterase inhibitor prior to passage of a~     ureteral access sheath in cases in which ureteroscopy is being used to approach a ureteral or~     renal stone.~      By relaxing the ureter, it is possible that a larger access sheath can be safely placed. This~     may allow for facilitating passage of the ureteroscope and extraction of stone fragments~     while precluding the development of potentially damaging intrarenal pressure from the flow of~     irrigant. The ureteral access sheath also protects the ureter from damage during the~     procedure. Placement of the largest access sheath possible is helpful in that larger stone~     fragments can be retrieved, the flow of irrigant is improved, and the surgical field is kept~     clear of blood or debris. To date, nobody has studied whether use of an uro-selective alpha~     blocker, alone, or in combination with a 5 phosphodiesterase inhibitor will result in passage~     of larger access sheaths.~      In this study participants will be randomized into 1 of 4 categories: Flomax (alpha-blocker),~     Cialis (5-phosphodiesterase inhibitor), a combination of the 2, or a placebo arm. In this~     study the placebo, or no active drug, is the current standard of care and will serve as a~     control from the other 3 groups.~   "
25750|NCT03229876|"~     Universal CART(U-CART) has a great advantage for its allogeneic T cell resource. After gene~     disruption of TCRα and HLA-1, U-CART will exempt from immunologic rejection by the receptor,~     and won't initiate GVHD. Thus U-CART would act as a off-the-shelf product for the treatment~     of tumor.~   "
25751|NCT03229863|"~     This study is examining the relationship between infant nutrition, gut health, and~     development. The fecal microbiota changes and develops, in large part due to the food that~     infants eat. These changes are important for many aspects of development. This study is~     designed to examine how the fecal microbiota changes when exclusively breastfed infants are~     first introduced to solid food, and how changes of the fecal microbiota are related to other~     aspects of development.~   "
25752|NCT03229850|"~     This study will use the euglycemic clamp technique to evaluate insulin absorption when~     insulin is administered subcutaneously in an area of subclinical lipohypertrophy vs an area~     of normal tissue.~   "
25753|NCT03229837|"~     Survivors of childhood cancer often suffer treatment-related toxicities, including chronic~     health conditions, high symptom burden and emotional distress, and decremented functional~     status and quality of life. Although some patient-reported outcome (PRO) tools are available~     for survivors of childhood cancer younger than 18 years old, very few studies have been~     designed to evaluate longitudinal measurement properties of these PRO tools. In this study~     the investigators propose to recruit participants from a cohort of diverse childhood cancer~     survivors who were treated at St. Jude Children's Research Hospital (St. Jude) to improve~     assessment tools for PROs and health-related quality of life (HRQOL).~      The purpose of this study is to measure the link between Patient Reported Outcome Measurement~     Information System (PROMIS) and clinical assessments of childhood cancer survivors over time.~     PROMIS is a questionnaire that measures patient-reported outcomes in adults and children.~      The study plans to enroll 300 children. Surveys will be completed by the children and their~     parents/legal guardians (a total of 600 surveys).~      PRIMARY OBJECTIVES:~        1. To evaluate the longitudinal construct validity of the PROMIS Pediatric measures for~          childhood cancer survivors by testing the association of change in PROMIS PRO scores and~          the change in health status measured by objective clinical assessment. Age at baseline~          and sex will be included in the analysis.~        2. To establish clinically meaningful classifications of the PROMIS Pediatric measures for~          childhood cancer survivors by referring PROMIS PRO scores to health status measured by~          clinical assessment. Age at baseline and sex will be included in the analysis.~        3. To estimate the minimally important differences (MIDs) of the PROMIS Pediatric measures~          by referring to the change of health status evaluated by anchor-based anchors and~          patient-based anchors for childhood cancer survivors. Age at baseline and sex will be~          included in the analysis.~   "
25754|NCT03229824|"~     Surgical site infection (SSI) after breast and axillary surgery occurs more often than for~     other clean surgical procedures. Infection in the setting of sick woman could delay the~     adjuvant therapy and result increase morbidity and mortality. Also this increased costs~     associated with health care.Surgical drains have been noted as a potential source for~     surgical site infections. The primary aim of the study is to determine if chlorhexidine~     occlusive dressings applied to the intervention drain sites effectively decreases rates of~     bacterial colonization in drain fluid and drain tips compared to standard care.~   "
25755|NCT03229811|"~     The goals of this work will be to 1) develop an ACP educational intervention that will be~     integrated into a standard pre-dialysis program and 2) evaluate its preliminary efficacy on~     increased use of ACP among patients with advanced CKD and their families.~   "
25762|NCT03229720|"~     Audio-Visual (AV) Distraction is a recent modality introduced to the entertaining market~     technology for adults and children. Some practitioners started using this modality of~     distraction in the dental practice to aid in psychological management of patients.~      This study is designed to compare between conventional dental visits (No Distraction) and~     dental visits aided with audio-visual distraction. Providing a safe, comfortable and~     entertaining dental environment will give pediatric children a better perception regarding~     the dental environment and motivate them for repetitive dental visits for better dental~     health care.~   "
25763|NCT03229707|"~     The aim of this study:~      Is to evaluate the accuracy of digital photography in optimizing shade matching when compared~     to conventional method of shade selection.~   "
25764|NCT03229694|"~     Tourniquet is widely used in orthopedic surgery. However, prolonged tourniquet inflation may~     cause a gradual rise in blood pressure, which named as tourniquet-associated hypertension.~     Thus, to effectively prevent the tourniquet related hemodynamic responses is important for~     patients receiving limb surgery.~      Tracleer is an endothelin receptor antagonist indicated for the treatment of pulmonary~     arterial hypertension. Tracleer can also be used to treat retistant hypertension. At present~     trial, the investigators are going to investigate the effect of Tracleer on~     tourniquet-associated hypertension during total knee arthroplasty.~   "
25765|NCT03229681|"~     Chronic heart failure (CHF) is the end stage of various kinds of cardiovascular diseases with~     high mortality. After a long period of medical treatment or surgical treatment, patients~     suffered great pain physically and mentally. How to improve the quality of life and prognosis~     in patients with CHF, which is a hot topic in the field of cardiac rehabilitation now.~     Baduanjin, as one of the traditional Chinese qigong exercises, has the features of generous~     stretch, soft consistency, dynamic but static, which is an appropriate movement pattern for~     CHF patients.~      To investigate the efficacy and safety of Baduanjin exercise for patients with coronary heart~     disease complicated with chronic heart failure (CHF). A randomized, controlled and~     prospective clinical trial was designed.~   "
25766|NCT03229668|"~     The aim of this study is to assess the effect of pregabalin administration on~     catheter-related bladder discomfort (CRBD). The study group includes patients that are about~     to be subjected to urological operations because of the high incidence of CRBD observed in~     this kind of surgical population.~   "
25767|NCT03229655|"~     Prospective, randomized comparison of the incremental dilation and stent exchange vs.~     sequential stent addition approaches for management of anastomotic biliary strictures will~     facilitate optimal management of patients who develop anastomotic biliary strictures after~     liver transplantation.~   "
25768|NCT03229642|"~     Opioid use disorder (OUD) is prevalent and causes substantial health and social burdens.~     Although evidence have showed the effectiveness of opioid agonist maintenance therapy in OUD,~     high drop-out rate and the requirement of continuing use of opioid agonists are the major~     problems. Therefore, to develop novel treatment for OUD is important.~      Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive method of brain~     stimulation used to treat a variety of neuropsychiatric disorders. Recent studies showed that~     there may be potential therapeutic effects in rTMS for addictive disorder, including reducing~     craving and substance use severity. The underlying mechanisms of rTMS in treating addictions~     may involve increased dopamine function in corticomesolimbic brain circuits and modulation of~     neural activity in brain circuits that relevant to addiction. However, the treatment results~     of rTMS in OUD were lacked, and the analysis in functional brain imaging study,~     neuropsychological tests and other potential biomarkers under rTMS treatment were limited,~     too.~      Thus, the investigators will conduct the add-on double-blinded, sham-controlled study rTMS~     treatment in 40-60 patients with OUD under methadone maintenance therapy. Patients will be~     allocated to active and sham rTMS in a 1 : 1 ratio, and participants will receive rTMS on the~     left dorsolateral prefrontal cortex (DLPFC) (15 Hz frequency, 4 seconds per train,~     inter-train interval of 26 seconds, 40 trains per session, total 11 sessions in 4 weeks). The~     treatment response, urine drug tests, craving scales and side effects to evaluate the~     therapeutic effects of rTMS will be examined. Neuropsychological assessments, functional~     magnetic resonance imaging (fMRI) and tests for potential biomarkers of immune parameters~     will also be measured during 12-weeks follow up. The study results will provide the important~     data in whether rTMS add-on methadone maintenance therapy is able to 1) reduce heroin use; 2)~     reduce craving for heroin; 3) be an effective treatment for OUD, and 4) be associated with~     improvement in fMRI, biological markers and psychological tests.~   "
25769|NCT03229629|"~     Pre-school undernutrition is a global problem with life long adverse consequences. One form~     of undernutrition, chronic undernutrition or stunting, affects 171 million children under the~     age of 5 worldwide. 35% of these children live in Africa. In Ethiopia, the focus of this~     study, in 2014, 44.5% of children under 5 were stunted. Stunting is the consequence of~     several factors including low birth weights, sub-optimal infant and complementary feeding~     practices and repeated illness. In Ethiopia, complementary feeding is sub-optimal; only 4% of~     children aged 6-24 months met the minimum dietary diversity recommended by WHO.~      The investigators hypothesize four main reasons why many children and mothers in Ethiopia~     fall short of best practice in terms of meeting nutritional needs and providing appropriate~     childcare.~      (i) Lack of information on healthy eating and appropriate child-feeding practices; (ii)~     Limited affordability; (iii) Limited accessibility to markets and diverse food items; and~     (iv) Limited peer effects in spreading information and adopting new practices.~      This study will assess the efficacy of the interventions that address these four barriers to~     optimal complementary feeding practices in Ethiopia. Using a cluster randomized control~     design, mother-father-child pairs in two localities, Holeta and Ejere will be enrolled.~     Treatment will be randomized at the garee (village) level. There will be five treatment arms~     and a control group: T1, weekly maternal nutrition BCC sessions for four months; T2, weekly~     maternal nutrition BCC sessions for four months and weekly paternal nutrition BCC sessions~     for three months; T3, receipt of a food voucher for six months; T4, weekly maternal nutrition~     BCC sessions for four months and receipt of a food voucher for six months; T5 weekly maternal~     nutrition BCC sessions for four months and weekly paternal nutrition BCC sessions for three~     months and receipt of a food voucher for six months; and C, a control group. Within~     household, recipient of voucher (mother or father) will be randomly selected.~   "
25770|NCT03229616|"~     The purpose of this study is to evaluate the safety and efficacy of BUCY+VP-16 and BUCY~     myeloablative conditioning regimens in diffuse large B-cell lymphoma undergoing autologous~     hematopoietic stem cell transplantation.~   "
25771|NCT03229603|"~     The Study goals are to test feasibility and acceptability of point of care HPV testing with~     227 women already accessing an existing cancer screening program in Mumbai, India. Describe~     HPV infection types in women screened. Compare if the quality of HPV clinician-collected and~     self-collected samples are equally efficient to detect HPV and cervical cancer precursor~     lesions. Compare the agreement between HPV GeneXpert and HPV HC2 test on the~     clinician-collected sample~   "
25772|NCT03229590|"~     Slipped capital femoral epiphysis represents approximately 10.8 cases per 100,000 children.~     The primary source for the blood supply of the head of the femur is the deep branch of the~     medial femoral circumflex artery. Loder described a classification for Slipped capital~     femoral epiphysis based on ability of the child to walk or not(walking=stable,~     non-walking=unstable).~   "
25846|NCT03228628|"~     Lumbar puncture (LP) is a frequent exam that can cause pain and anxiety. In a pilot~     single-center study, it has been shown that nitrous oxide use during the procedure was able~     to reduce both pain and anxiety (Moisset et al., Eur J Neurol 2017). The goal of this~     multi-center trial is to confirm these results in a larger and more heterogeneous group of~     patients having a LP.~   "
25773|NCT03229577|"~     The Yale College Emotional Intelligence project aims to highlight the beneficial impact of~     wellness programs for Yale students. The investigators will examine the benefits of 3~     empirically-validated programs (Emotional Intelligence, KORU Mindfulness & YESplus Yoga~     Breathing) for Yale students on measures of general well-being (e.g. perceived stress,~     gratitude etc). The study will also include a no-treatment control group as a comparative~     measure to the well-being programs. The goal of the study is to show how each program~     benefits student well-being over time (immediately after the workshop and 1 month out from~     the workshop). The hypothesis is that all 3 workshops will decrease stress and improve~     well-being and that the manner in which each workshop will do so may be different (e.g. KORU~     will benefit student well-being by increasing mindfulness and self-compassion whereas~     Emotional Intelligence may benefit student well-being by improving cognitive emotion~     regulation). In addition to the self-report measures, the study will measure physiological~     outcomes of stress, heart rate variability, and sleep using a wearable device (Firstbeat).~     Given the current state of mental health challenges and stress on college campuses, the goal~     of this randomized-control trial is to strengthen the literature on wellness programs for~     students and to show that student well-being can significantly increase through effective~     interventions.~   "
25774|NCT03229564|"~     This phase IIb trial aims to evaluate the efficacy and safety of EHSG-KF (synonym denovoSkin)~     in comparison to meshed STSG in children with partial deep dermal and full thickness burns.~   "
25775|NCT03229551|"~     The purpose of this investigation is to conduct a randomized controlled trial within a~     subgroup of difficult-to-treat patients with CRS, evaluating the use of topical xylitol~     treatment concurrently with topical steroid/antibiotics combination in the effort to disrupt~     biofilms and improve disease control. The effectiveness of topical surfactants is a research~     gap in treating CRS but has promising correlates in other medical fields. Specifically, the~     investigators will be studying the effect of topical xylitol therapy on biofilm production~     with the use of PCR bacterial sequencing before and after medical intervention.~   "
25776|NCT03229538|"~     This study's objective is to determine the pharmacokinetics (PK)/pharmacodynamics (PD),~     safety and efficacy of methylprednisolone in neonates undergoing heart surgery with~     cardiopulmonary bypass. This is a prospective, double blind, multi-center, placebo-controlled~     safety and efficacy study. Blood samples will be collected from a subset of enrolled study~     participants to evaluate multiple dose methylprednisolone PK/PD. Participants will be~     randomized in a 1:1 fashion to intravenous methylprednisolone versus placebo. Study~     drug/placebo will be administered 8 to 12 hours before the anticipated start time of surgery~     and in the operating room at the time of initiation of cardiopulmonary bypass. Patients will~     be followed for primary and secondary outcomes for the duration of their hospitalization.~     Serious study drug-related adverse events will be collected for 7 days after the last dose of~     study drug.~   "
25777|NCT03229525|"~     Post-traumatic Stress Disorder (PTSD) is a debilitating mental disorder that affects~     approximately 7% of the general population. This project's aim is to develop a greater~     understanding of the efficacy and underlying mechanisms of narrative exposure based~     treatments for PTSD. Adult participants (N=162) who meet DSM-5 criteria for PTSD will be~     enrolled in a 3-arm randomized clinical trial consisting of trauma-related expressive~     writing, trauma-related expressive speaking, or a factual expressive writing control~     condition. Treatments will be manualized and conducted entirely through the Qualtrics survey~     platform. Treatment will consist of six sessions, three per week over two weeks, taking place~     via the internet. Assessments will be conducted pre-treatment, post-treatment, and at 1-month~     follow-up in the lab. Assessments will be comprised of symptom self-report measures as well~     as two tasks completed in an eye tracker: a reading task to evaluate mechanisms underlying~     trauma narrative processing and a sentence production task to evaluate attentional shifts~     when producing verbal information~      Specific Aims and Hypotheses:~        1. Develop and test the relative efficacy of two cost-effective internet-based expressive~          trauma therapies (written vs. spoken) relative to a non-trauma writing control for PTSD.~          We hypothesize that both trauma-focused expressive therapies will achieve more favorable~          outcomes at posttreatment and follow-up on measures of PTSD and depression symptoms,~          posttraumatic growth, and quality of life compared to the writing control.~        2. Conduct exploratory analyses testing baseline PTSD severity, depression severity, trauma~          type, time since trauma, and emotional engagement in moderating the differential effects~          of the selected expressive therapies.~        3. Test the mediational effects of pre- to posttreatment changes in (1) active language~          processing with eye tracking (i.e. how long certain words are fixated on). (2) selected~          linguistic elements (i.e., frequency of emotional words, frequency of the pronoun I),~          (3) perceived self-efficacy to cope with trauma memories; (4) perceived threat~          appraisals associated with intrusive trauma memories on treatment outcome at follow-up.~          We hypothesize that (1) fewer and shorter fixations on ideographic (i.e. personally~          relevant) trauma words when reading the trauma narrative in the eye tracker will be~          associated with reductions in PTSD symptoms at follow-up. (2) increased use of emotional~          words over the course of writing sessions will be associated with reductions in PTSD and~          depression symptoms at follow-up; (3) pre- to posttreatment increases in trauma memory~          acceptance self-efficacy; and (4) pre- to posttreatment reductions in trauma memory~          threat appraisals will be associated with greater symptom reduction at the follow-up~          assessment.~   "
25778|NCT03229512|"~     Skin toxicities are a major complication to cancer therapies. They can be painful and limit~     the amount of drug that can be received by cancer patients, preventing the patients from~     receiving optimal doses of drug. One such cutaneous toxicity, hand-foot skin reaction (HFSR),~     is caused by next generation targeted agents that are in routine use for the treatment of~     kidney and liver cancer. HFSR is characterized by swelling, redness, and pain of the palms~     and soles, in addition to the development of painful or thickened callus-like plaques with~     fissures in areas of friction and pressure. The investigators have identified a topical~     skin-directed therapy, 1% topical sildenafil cream, that the investigators believe will be~     useful in preventing and ameliorating this painful, skin side effect associated with the~     targeted agents sorafenib and sunitinib. This project proposal aims to conduct an open-label~     pilot study to assess whether pre-medication with this cream can be an effective way of~     preventing or decreasing the severity of hand-foot skin reaction, improving their quality of~     life on therapy and enabling the patients to receive optimal amounts of their anti-cancer~     drug.~   "
25779|NCT03229499|"~     The primary objectives of this study are to determine whether the study drug, anastrozole may~     improve six minute walk distance at six months compared to placebo and to assess safety and~     side effects up to twelve months in pulmonary arterial hypertension (PAH).~   "
25780|NCT03229486|"~     The aim of this study is to investigate the effect of sugammadex vs. a conventional~     acetylcholinesterase inhibitor, neostigmine on emergence delirium (ED) during~     sevoflurane-rocuronium anesthesia in pediatric patients Additionally, the efficacy features~     of sugammadex compared to neostigmine will be examined by measuring the time from start of~     administration of reversal agents to recovery of train-of-four (TOF) ratio to 0.7, 0.8, and~     0.9.~      Although the etiology of ED remains unclear, a sense of suffocation or breathing difficulty~     during emergence from anesthesia has been suggested as a possible cause. Thus, reversal of~     neuromuscular blockade with sugammadex in pediatric patients maintained with~     sevoflurane-rocuronium anesthesia may decrease ED due to its faster reversal of neuromuscular~     blockade and decreased possibility of residual blockade.~   "
25781|NCT03229473|"~     People with chronic obstructive pulmonary disease (COPD) have balance problems and are at~     risk of falling. New guidelines recommend balance assessment be included in pulmonary~     rehabilitation (PR) however no specific tests are recommended. Our goal is to determine the~     best balance test for identifying COPD patients who are at risk of falling. In this study,~     COPD patients who report balance problems or falling in the last year will participate in a~     testing session. Balance, balance confidence, lower body strength, exercise tolerance and~     perceived physical limitations will be assessed. The number of falls over the following year~     will be recorded using monthly calendars.~   "
25782|NCT03229460|"~     The purpose of this study is to determine the impact of hign-flow nasal therapy on the adult~     with hypercapnia and hpoxemia respiratory faliure in comparison with standard oxygen therapy~     ang noninvasive ventilation.~   "
25783|NCT03229447|"~     This study compares two methodologies for improving access to medication assisted treatment~     (MAT) in Ohio courts where MAT is currently restricted or prohibited. All participating~     courts are asked to view two educational modules. Module 1 addresses the nature of opioid~     addiction and treatment. Module 2 addresses concerns specific to criminal justice such as~     misuse and diversion of medications. Courts selected for the experimental group also receive~     a hands-on change team initiative in which specially trained professionals work with court~     staff to provide education and instrumental assistance in order to improve access to MAT for~     court supervisees who are opioid-dependent.~   "
25784|NCT03229434|"~     In a randomized crossover design, approximately 50 healthy participants will be randomly~     exposed to outdoor mountain hiking (approximately 6 hours each) in two different areas: an~     anthropogenically influenced area and in a widely pristine area.~   "
25785|NCT03229421|"~     The purpose of this study is to determine whether any diagnostic patterns exist in the~     symptom presentation of Zika Virus.~   "
25786|NCT03229408|"~     Polycystic Ovary Syndrome (PCOS) is characterized by hyperandrogenism, ovulatory dysfunction~     and polycystic ovaries. Insulin resistance (IR) is a common feature of PCOS, and the~     resultant hyperinsulinemia is theorized to promote hyperandrogenism in the disorder. However,~     30-50% of women with PCOS who are lean do not have insulin resistance. Women with PCOS also~     exhibit chronic low-grade inflammation. In PCOS, glucose ingestion activates nuclear factor~     ĸB (NFĸB), the cardinal signal of inflammation culminating in upregulation of the~     inflammation pathway within mononuclear cells (MNC). This phenomenon is independent of excess~     adiposity and is highly correlated with circulating androgens. In addition, in vitro exposure~     to proinflammatory stimuli is capable of directly stimulating ovarian theca cell androgen~     production. Nonacetylated salicylates suppress NFĸB activation and are well tolerated in~     humans.~      The proposed research is a randomized double-blind placebo-controlled study of 90 women with~     PCOS. Forty-five subjects with PCOS (15 lean without IR), 15 lean with IR and 15 obese)~     receiving salsalate, a nonacetylated salicylate, at an oral dose of 3-4 gm daily for 12 weeks~     will be compared with 45 age- and body-composition-matched control women with PCOS receiving~     placebo. The overarching hypothesis is that inflammation contributes to ovarian dysfunction,~     independent of excess adiposity or IR.~      The specific aims are, I: To examine the effect of salsalate administration on the ovarian~     capacity to secrete androgen and on insulin sensitivity in PCOS. II: To examine the effect of~     salsalate administration on the inflammatory response of mononuclear cells induced by lipid~     ingestion and glucose infusion in PCOS. The approach involves evaluation of ovarian androgen~     secretion in response to human chorionic gonadotropin (HCG) administration and insulin~     sensitivity during the euglycemic phase of a two-step pancreatic clamp along with ovulation~     monitoring before and after salsalate administration. The inflammatory response of MNC to~     lipid ingestion and the hyperglycemic phase of the two-step clamp will also be evaluated~     during treatment by measuring reactive oxygen species, the mRNA and protein content of~     inflammation markers, NFĸB activation and cytokine release in culture.~      The investigators expect that women with PCOS receiving salsalate will exhibit decreased~     ovarian androgen secretion and reduced inflammation regardless of adiposity or IR status.~     These results will be significant if they show a causal contribution of inflammation to~     ovarian dysfunction in PCOS, thus improving our understanding of the pathogenesis of PCOS,~     opening previously unexplored therapeutic avenues that are not necessarily dependent on~     improving IR, and guiding the design of future studies aimed at determining what~     interventions will optimally attenuate inflammation in PCOS to reduce medical disease and~     enhance fertility.~   "
25787|NCT03229395|"~     Several studies have shown that lean mass, in particular muscle mass, is an excellent~     predictive survival factor in many diseases. A better knowledge of the mechanisms responsible~     for muscle atrophy and the identification of atrophic process markers are deeply needed for~     the development of new anti-atrophic therapies. Either as drugs used to treat several medical~     conditions or as endocrine hormones released in response to many stress situations (e.g.,~     sepsis, cancer, insulinopenia…), glucocorticoids (GC) are recognized to play a major role in~     skeletal muscle atrophy. Indeed, the inhibition of GC action by a receptor antagonist (RU486)~     or by muscle-specific invalidation of the GC receptor inhibits the muscle atrophy in these~     stress situations. Therefore, all these data clearly indicate that GC play a major role in~     skeletal muscle atrophy observed in several conditions. Emerging evidence has revealed that~     the skeletal muscle has a secretory function. Human skeletal muscle secretome was first~     estimated at about 300 proteins by computational analysis and proteomic analysis have~     recently confirmed these results. Some of these secreted proteins, conceptualized as~     myokines, can act locally on muscle cells through autocrine/paracrine loops and on~     surrounding tissues such as muscle blood vessels or can be released into the blood stream to~     produce systemic effects. One prominent example is interleukin (IL)-6 which is released into~     circulation by contracting skeletal muscle and can regulate metabolic and inflammatory~     processes. As IL-6, several other potential myokines have been identified including IL-8,~     IL-15, insulin-growth factor I (IGF-I), follistatin-like 1 (FSTL1) or fibroblast-growth~     factor (FGF)-21. Moreover, secreted proteins may also reflected metabolic changes which take~     place in muscle cells. Indeed, myoblast differentiation is accompanied by dramatic changes in~     the secreted proteins profile as increased expression of Semaphorins, IGF-I, matrix~     metalloproteinase (MMP)-2 or Collagens. Thereby, the investigators hypothesized that skeletal~     muscle atrophy induced by GC is associated with specific alterations of the muscle secretome.~     The aim of this project is to identify the GC-induced changes in the secretome of human~     skeletal muscle cells in culture (in vitro approach) and to determine how these changes~     translate into the circulation of subjects exposed to high concentrations of GC (Cushing's~     syndrome) (in vivo approach). Characterization of these changes in human subjects should~     allow to better understand the cellular mechanisms involved in muscle atrophy and might lead~     to identify circulating biomarkers associated with skeletal muscle atrophy, as telopeptides~     are for bone tissue.~   "
25788|NCT03229382|"~     The objective of the study is the evaluation of efficacy and safety of obinutuzumab~     preemptive treatment at the time of the molecular relapse after first line immunochemotherapy~     with autologous stem cell transplantation in mantle cell lymphoma patients.~   "
25789|NCT03229369|"~     Persistent rotational instability after standard ACL reconstruction have been extensively~     described, and it has been shown to keep straight correlation with worse outcomes~     post-operatively (Chouliaras 2007, Kocher 2004). Anterolateral ligament (ALL) injury have~     been shown to play a relevant role in the genesis of rotational instability of the knee~     (Claes 2013, Helito 2013). Many anatomical publications have defined the ALL as a distinct~     ligament (Claes 2013). Meanwhile, some authors have proposed the association of ACL and ALL~     reconstruction in selected ACL-deficient individuals to further enhance knee stability~     postoperatively (Sonnery-Cottet 2015, Dodds 2014). Lack of consensus still predominates among~     ACL experts regarding the reliability of the combined ACL and ALL considering the controversy~     that involves both ALL anatomy and biomechanics (Guenther D 2016, Kittl C 2016). Clinical~     trials with high level of evidence and long term follow-up may be useful in order to~     determine the reliability of the combined procedure in the clinical setting.~      So, the present study aims to compare the effectiveness of the combined ACL and ALL~     reconstruction with isolated ACL reconstruction in individuals with high-risk of ACL~     re-rupture, through a randomized controlled trial.~   "
25790|NCT03229356|"~     Smoking is the number one cause of preventable death in the United States. Given the~     magnitude of the problem, interventions aimed at promoting smoking cessation have the~     potential to make large changes in improving health outcomes. Resources to aid with smoking~     cessation such as telephone-based counseling are generally underutilized. The electronic~     medical record (EMR) in use at Johns Hopkins has limited decision support to promote referral~     to the Maryland Quit Line, a free smoking cessation counseling resource. The investigators~     propose a cluster randomized trial (Implementation-RCT hybrid design) with a waitlist control~     at the 22 Johns Hopkins Community Physicians (JHCP) sites, which offer primary care. The~     intervention will include a multi-modality intervention to promote provider use of smoking~     cessation resources which include an Epic-based Best Practice Advisory (BPA) that allows~     providers to electronically refer to the Maryland State Quit Line, educational materials, and~     provider visits with Quit Line representatives to review use of smoking cessation practices.~     Sites will be randomized to one of three arms with increasing support: 1) six-month waitlist~     control; 2) BPA with optional educational modules; 3) BPA with online educational modules, a~     quick-reference educational document, and additional visit with Quit Line representatives.~     The investigators hypothesize that by implementing a new Epic BPA that allows providers to~     easily refer to the Maryland Quit Line electronically, investigators will increase use of~     this resource. The investigators also hypothesize that adding additional educational~     materials and having Quit Line representatives perform educational outreach visits will~     further increase use of the Quit Line and will increase prescription of medications to assist~     with smoking cessation. Ultimately The investigators hope to improve patient care by~     increasing providers' use the Maryland Quit Line and pharmacotherapy. The investigators hope~     that the use of these resources will decrease smoking rates and thereby improve patient~     health and outcomes while improving JHCP quality metrics.~   "
25791|NCT03229343|"~     Idiopathic pulmonary fibrosis (IPF) is a rare and severe disease with a survival median~     between 2 and 4 years which leads to a profound alteration of the quality of life.~      In thoracic oncology, the systematic and early intervention of a palliative care team result~     in an improvement of quality of life for patients.~      In the princeps study published in 2010, the early intervention of a dedicated palliative~     care team was compared to standard care in a randomized trial of 150 patients and shows a~     significant improvement : (i) of quality of life (main objective), (ii) of depression scores~     and even overall survival (11.6 months vs. 8.9 months, P = 0.02), (iii) a benefit in terms of~     understanding the diagnosis and therapeutic goals (3), (iv) diminution of adapted~     hospitalization in end of life (in emergency or not).~      Considering some analogy points between IPF and advanced lung cancer (prognosis, respiratory~     symptom, psychological burden), it seemed reasonable to assume that the joint systematic~     intervention of chest physician and palliative care team may provide a significant benefit in~     terms of quality of life for patients with severe IPF.~   "
25792|NCT03229330|"~     This study compares the effect of adjuvant treatment of Low-level Light Therapy with~     conventional treatment in the tissue repair of venous ulcers in patients undergoing~     outpatient nursing consultation. For the evaluation of the cases clinical indicators of~     Nursing Outcomes Classification have been used.~   "
25793|NCT03229317|"~     Early lung function deficits represent a significant risk factor for the evolution toward~     chronic obstructive pulmonary disease later in life. Prematurity and in utero tobacco smoke~     exposure are already known to predispose children to develop a non-reversible obstructive~     ventilatory defect in adulthood. The role of vitamin D status during pregnancy is less~     certain. In humans, low vitamin D concentrations during pregnancy are associated to an~     increased risk of asthma in children. In murine models, low vitamin D concentrations during~     pregnancy are associated to structural abnormalities of the airways in mouse pups.~     Investigators hypothesized that vitamin D play a role in early airways development, from the~     first trimester of pregnancy. To bring arguments to this hypothesis, the investigators will~     study the association of airway resistance in children aged 5 to 6 years old with the~     concentration of vitamin D during the first trimester of pregnancy in their mothers.~   "
25794|NCT03229304|"~     The aim of the study is to evaluate the uterine artery doppler just before labour in term low~     risk pregnancies. And to investigate with this measurement if investigators could foreseen~     the amount of postpartum hemorrhage looking at decreased in the hematocrit values.~   "
25795|NCT03229291|"~     This study is a single-center, randomized, single-blind, placebo-controlled, multiple~     ascending dose study of SM04755 solution applied topically once daily for 14 days to intact~     skin overlying the inner thigh of healthy subjects at an estimated body surface area (BSA) of~     80 cm^2. Dosing cohorts will consist of 8 subjects who will be randomized 3:1~     (SM04755:placebo).~   "
25796|NCT03229278|"~     This phase I trial studies the best dose and side effects of trigriluzole in combination with~     nivolumab and pembrolizumab in treating patients with solid malignancies or lymphoma that has~     spread to other places in the body or cannot be removed by surgery. Trigriluzole may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal~     antibodies, such as nivolumab and pembrolizumab, may interfere with the ability of tumor~     cells to grow and spread. Giving trigriluzole in combination with nivolumab and pembrolizumab~     may work better at treating patients with solid malignancies or lymphoma.~   "
25797|NCT03229265|"~     Hyperkalemia (high potassium in blood) is a common condition found in kidney transplant~     patients. Risk factors include poor kidney function and exposure to various drugs. Regardless~     of the causes, current treatment options are limited. Previously, the only available~     potassium binder for lowering potassium in the blood is sodium polystyrene sulfonate, which~     has unknown drug interaction profile with transplant medications. Patiromer is a newly~     approved potassium binder indicated for the treatment of hyperkalemia. Kidney transplant~     patients with hyperkalemia may benefit from patiromer. However, the interaction of patiromer~     and transplant medications has not been studied. The goal of this study is to look into the~     drug interactions between patiromer and transplant medications.~   "
25798|NCT03229252|"~     28-Day double-blinded efficacy and safety trial of SPX-101 Inhalation Solution in adult~     subjects with cystic fibrosis.~   "
25799|NCT03229239|"~     The purpose of this study is to determine whether corneal stroma implantation is effective in~     the treatment of keratoconus.~   "
25843|NCT03228667|"~     This is a Phase IIb, single-arm, open-label study of ALT-803 in combination with~     pembrolizumab or nivolumab in patients with advanced or metastatic non-small cell lung cancer~     who have progressed following an initial response to treatment with PD-1 checkpoint inhibitor~     therapy. All patients will receive four cycles of treatment. Each cycle is six weeks in~     duration. All patients will receive ALT-803. Patients will also receive either pembrolizumab~     or nivolumab. Radiologic evaluation will occur at the end of each treatment cycle. Following~     four cycles of combination treatment, patients will no longer receive ALT-803 but will be~     eligible to continue their respective pembrolizumab or nivolumab therapy through 24 months,~     at the discretion of the treating physician. Patients will be followed for disease~     progression, post-therapies, and survival through 24 months.~   "
25800|NCT03229226|"~     Since 2007, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has~     required evaluation of practicing attending physicians by management to ensure that~     procedural skills and medical care are meeting the accepted standards of care as assessed by~     each individual institution. This assessment is known as the ongoing professional practice~     evaluation (OPPE). There are several methods by which this can be accomplished, including~     through chart review of clinician practice and by verbally assessing knowledge of the steps~     required to do a particular procedure. However, for infrequently performed or complicated~     procedures, these methods may not allow objective evaluation on a regular basis. Simulation~     using task trainers or manikin models offers an alternative method of objective evaluation in~     a standardized setting.~      The goal of this study is to develop two simulated scenarios to assess physician skill in~     relatively uncommon procedures and compare the data obtained against the verbal assessment~     and chart review model previously used at our institution. Two raters will assess each~     practitioner's verbal and simulated procedures. They will also assess globally their~     confidence that the physician is capable of performing the procedure safely and correctly~     based on the verbal or simulated trial.~      The investigators anticipate that using a simulated experience for assessment will increase~     the ability of raters to assess proficiency for the purposes of an OPPE, specifically by~     increasing the number of critical procedural components that can be objectively evaluated.~     The investigators hypothesize that there will not be a strong relationship between the scores~     obtained on the verbal assessment and the scores obtained on the task trainer assessment. The~     investigators anticipate that there will be a portion of study participants that do not meet~     a minimum passing standard and may require additional deliberate practice and further~     testing.~   "
25801|NCT03229213|"~     Cystic fibrosis (CF) is a disease that affects multiple systems, however, the accumulation of~     secretion in the airways contributes to the fact that pulmonary complications are the main~     responsible for the high rates of morbidity and mortality. Physical exercise can be an~     important component in the treatment of these patients, and modalities such as Nintendo Wii~     and Xbox One stand out as feasible and innovative methods that can contribute to increase~     adherence to rehabilitation. Thus, the objective of this study is to compare the~     cardiorespiratory responses during a maximal exercise test with the use of Nintendo Wii and~     Xbox One in patients with CF and healthy individuals. Patients with a clinical diagnosis of~     CF, aged from 6 to 30 years old and in stable clinical conditions will be included. For~     healthy individuals, those who are considered healthy from the application of a health~     questionnaire and also aged from 6 to 30 years old will be included. Patients in both groups~     with cardiopathies, musculoskeletal diseases, neurological diseases or signs of pulmonary~     exacerbation will be excluded. Participants will complete a questionnaire to assess their~     level of physical activity. Afterwards, cardiopulmonary exercise test (CPET) will be~     performed (visit 1), followed by the use of video games (visit 2). The video game will be~     practiced using a Nintendo Wii and a Xbox One (10 minutes each). A rest of 10 minutes will be~     provided between the use of each video game. During the interactive games, patients will use~     an accelerometer to assess the level of physical activity. In parallel to this, healthy~     subjects will be invited to perform the same tests in two visits. To evaluate the perception~     of fatigue, the OMNI scale will be used. In addition, individuals will be asked to evaluate~     their level of satisfaction after each game.~   "
25802|NCT03229200|"~     Multicenter, open-label, prospective treatment protocol that provides continued access to~     ibrutinib to subjects who have completed parent ibrutinib studies, are still benefitting from~     treatment with ibrutinib, and have no access to commercial ibrutinib for their underlying~     disease within their region.~   "
25803|NCT03229187|"~     Cervical cancer is one of the major health problems for chinese women. Besides surgery and~     radiotherapy, neoadjuvant chemotherapy has been proved to be an effective program by many~     studies.~      However, not all patients respond well to neoadjuvant chemotherapy. Knowing the therapeutic~     effect of the neoadjuvant chemotherapy before receiving it can not only reduce the economic~     burden, but also more importantly save time to take more suitable treatments.~      This study is undertaken to build specific molecular signatures to predict the effects of~     neoadjuvant chemotherapy.~   "
25804|NCT03229174|"~     This is a double blind placebo controlled trial in Parkinson's disease (PD) patients with~     neurogenic orthostatic hypotension (NOH). Investigators hypothesize that the study drug~     (droxidopa) may improve cerebral perfusion more robustly than systemic BP, possibly by direct~     action within the CNS vasculature. This study is designed to determine if droxidopa improves~     cerebral perfusion measures in PD patients with NOH, in addition to peripheral BP measures~     and subjective responses.~   "
25805|NCT03229161|"~     It is well-known that regular physical activity (PA) can improve glycemic control and~     physical fitness in type 2 diabetes patients. However, studies examining the effects of PA in~     patients with gestational diabetes mellitus (GDM) are limited. Interval walking training~     (IWT) is a careful type of PA consisting of repeatedly cycles of 3 min. fast and slow~     walking. The investigators aimed to examine, if IWT is feasible as PA intervention for GDM~     patients, and to examine the effects of IWT on glycemic control, PA levels and physical~     fitness.~   "
25806|NCT03229148|"~     Objective of the study: to assess whether pharmacological sedation or general anesthesia for~     treatment of anterior circulation ischemic stroke with endovascular mechanical thrombectomy~     is associated with difference in morbidity (neurological outcome and peri-procedural~     complications).~   "
25807|NCT03229135|"~     This was a retrospective study that all teicoplanin-treated adult patients with Gram-positive~     infections admitted to Zhengzhou Central Hospital affiliated to Zhengzhou University from~     February 2015 to August 2016.~   "
25808|NCT03229122|"~     The multi-centered, cross-sectional investigations shall be conducted in this study with the~     objective of identifying the ownership ratio of gBRCAm on the newly diagnosed patients with~     epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer in Japan.~   "
25809|NCT03229109|"~     Monitoring of a person's physical status is a key point for maintaining of healthy life.~     Wearable devices provide a unique possibility for real-time monitoring. This study aims to~     estimate the accuracy of Spectrophon Dehydration Body Monitor (DBM) incorporated in~     smartwatch Samsung Gear S2 and sport band Samsung Gear Fit2 by comparing data obtained by DBM~     with the total weight lost during exertion.~   "
25810|NCT03229096|"~     Apatinib plus XELOX regime as Neoadjuvant Therapy in Locally Advanced Gastric Cancer~     PatientsWith lymph node metastasis~   "
25811|NCT03229083|"~     To determine if Carevive software, which monitors treatment-related toxicities and then~     generates self-care management plans for these symptoms, will be feasible to implement among~     patients with metastatic renal cell carcinoma (RCC). Additionally for collection of~     preliminary data on treatment-related toxicities, quality of life, distress level, and drug~     adherence.~   "
25873|NCT03228277|"~     The purpose of this study is to evaluate the efficacy of Olmutinib(Olita®) in patients with~     T790M-positive non-small cell lung cancer (NSCLC) confirmed using DNA extracted from~     extracellular vesicles of bronchoalveolar lavage fluid.~   "
25812|NCT03229070|"~     Post-lateral thoracotomies and assisted thoracic surgery (CTVA) are the main surgical~     approaches for pulmonary resections. One of the counterpoints of these surgical approaches is~     postoperative pain, which in addition to causing ventilatory changes and reduction of lung~     capacities, contributes to bed rest and consequent decrease in patients' functionality. These~     complications increase hospitalization time and hospital costs, being determinant factors for~     perioperative morbidity and mortality. In order to prevent these outcomes of reduce the~     functional capacity of patients, new physiotherapeutic approaches have been adopted, such as~     the use of the cycloergometer. Recent studies show that the early use of this device brings~     benefits such as: improved blood circulation and venous return, increased muscle strength,~     improved functional capacity and reduced symptoms of dyspnea and fatigue. This study aims to~     compare the effect of interval training with continuous cycle ergometer training on~     performance in the six-minute walk test. Randomized and controlled clinical trial performed~     with patients submitted to elective thoracic surgery, hospitalized at the intensive care unit~     (ICU) and in the hospitalization unit of the Hospital Pavilhão Pereira Filho of the Santa~     Casa de Misericórdia Brotherhood of Porto Alegre. Participants will be randomized into three~     groups: control group (CG), interval exercise group (GHG) and continuous exercise group~     (GEC). Functional capacity assessments will be performed through the six-minute walk test~     (6MWT) and the chair sit and lift (TSL) test in 30 seconds, and evaluation of the clinical~     state of fatigue through the revised Piper-Fatigue Scale. The evaluations will be performed~     preoperatively and at hospital discharge.~   "
25813|NCT03229057|"~     To determine the effect of Oral Contraceptive Pills (OCP) verses Metformin verses OCP and~     Metformin on the prevalence of Metabolic Syndrome (MetS) and its components in~     overweight/obese women with Polycystic Ovary Syndrome (PCOS).~      The combination of OCP and metformin (OCP, through lowering androgens, and metformin, through~     improvement in insulin sensitivity) will affect the prevalence of MetS, thereby altering the~     risk profile for the development of diabetes and possible cardiovascular disease (CVD) in~     young women with PCOS.~   "
25814|NCT03229044|"~     Adipose tissue is strongly correlated to obesity and diabetes which are two major problems in~     the worldwide. Adipose tissue is involved in modulating glucose and energy metabolism locally~     and systemically by secreting factors, called adipocytokines. Tetranectin (TN), a novel~     adipocytokine, is secreted by adipose tissues. TN may regulate the glucose/energy homeostasis~     to affect lipid accumulation.The role of TN in adipocytes with or without TN on regulation of~     adipose tissue growth and lipid metabolism is valuable to be studied.~      Materials and methods: Secreted proteins from human adipocyte culture medium were deciphered~     using 2-D polyacrylamide gel electrophoresis and determined by LC/MS with MALDI-TOF analysis~     of proteins. Adipose tissues were obtained from the breast of 15 women undergoing mastectomy.~     Serum samples from 200 normal healthy people and 54 breast cancer patients were assigned to~     either a lean or obese group according to the body mass index. The TN protein concentration~     was measured in the culture medium of stromal-vascular fraction (SVF)-derived adipocytes from~     healthy humans, breast cancer patients, pigs and also from 3T3-L1 cells. Associations between~     plasma TN and other biomarkers were assessed with Pearson's correlations and multivariable~     linear regression.~   "
25815|NCT03229031|"~     To demonstrate the superior effect of ES135 combined with spinal cord repairing surgery,~     compared to a placebo control with spinal cord repairing surgery, on post-surgery motor~     function recovery as measured by the changes from baseline of ISNCSCI Motor Scores in~     subjects~   "
25816|NCT03229018|"~     study target is assessment of the accuracy of linear measurement obtained from CBCT images on~     3D volumetric rendering and multiplanar slices with different voxel sizes~   "
25817|NCT03229005|"~     The purpose of this clinical and radiographic study will be to determine what influence on~     marginal bone loss has the thickness of soft tissues and the height of the prosthetic~     abutment and eventually determine which of the two factors is the most important.This~     research was designed as a multicentre cohort observational study. Eight clinical centers~     will treat patients through the placement of a single dental implant. The implants will be~     prosthetically loaded about 3 months after placement and periapical radiographs will be~     acquired at each time-point.~   "
25818|NCT03228992|"~     The study will assess the sensitivity of the Delayed Onset Muscle Soreness Model by comparing~     the safety and efficacy of oral ibuprofen to placebo over 24 hours.~   "
25819|NCT03228979|"~     Recurrent stroke, cardiovascular morbidity and mortality are important causes of poor outcome~     in patients with index stroke. According to INTERSTROKE study 80% of stroke are preventable~     due to presence of modifiable risk factors. However lack of knowledge that stroke and~     cardiovascular diseases are preventable is major hurdle to reduce the incidence of recurrent~     stroke and cardiovascular morbidity. This is further compounded by the non-compliance to~     medications, exercises smoking cessation and other lifestyle modifications.~      Stroke awareness has proven to be useful in improving early arrival of stroke patients to~     emergency thus increasing the thrombolysis rates. Early stroke prevention education using~     print and audio-visual media may be useful. In addition the use of pervasive mobile phone~     platform may help us reach patients during multiple intervals in a timely manner.~      Study aims to use structured semi-interactive stroke prevention package to reduce the risk of~     recurrent strokes, myocardial infarction and death in patients with sub-acute stroke after~     one month.~   "
25839|NCT03228719|"~     Background: The definitive treatment for knee osteoarthritis is Total Knee Replacement (TKR),~     which results in clinically meaningful improvements in pain and physical function. However,~     evidence suggests that physical activity remains unchanged after TKR. This randomized~     clinical trial is investigating the efficacy, fidelity, and safety of a physical therapist~     administered physical activity intervention for people after TKR.~      Methods/Design: One hundred and twenty-five individuals, over the age of 45, who seek~     outpatient Physical Therapy (PT) following a unilateral TKR will be randomized into a control~     and intervention group. The intervention group will receive a weekly physical activity~     intervention during PT, which includes a FitbitTM monitor, individualized step goals, and~     face-to-face feedback provided by the physical therapist. Efficacy of the intervention will~     be measured by minutes/week spent in Moderate-to-Vigorous Physical Activity (MPVA) using an~     Actigraph GT3X monitor from enrollment to discharge, 6 months and 12 months from discharge~     from PT. The association of self-efficacy for exercise and kinesiophobia with physical~     activity will also be measured at the same time points. Fidelity and safety of the~     intervention will be assessed during outpatient PT.~      Discussion: This study is designed to fill a critical clinical need to increase physical~     activity after TKR. The primary objective of the study is to evaluate the efficacy of a~     physical therapist administered physical activity intervention for people after TKR. The~     secondary objectives are to evaluate the fidelity and safety of a physical therapist~     administered physical activity intervention for people after TKR and to investigate changes~     in self-reported and performance-based physical function after a physical therapist~     administered physical activity intervention for people after TKR. The tertiary objective is~     to explore the association of psychosocial factors with physical activity 6 and 12 months~     after discharge from a physical therapist administered physical activity intervention for~     people after TKR. The findings will be used to support a large multi-site clinical trial to~     test the effectiveness, implementation, and cost of this intervention.~   "
25820|NCT03228966|"~     Background: In children and adults living with HIV, cardiomyopathy is a major source of~     comorbidity. Traditional echocardiographic measures are insensitive and consequently~     cardiomyopathy often goes undiagnosed until late stages of disease. Myocardial deformation~     imaging represents a promising means to identify early dysfunction, but to date there have~     been no large studies using strain or strain rate to assess cardiac function in children with~     HIV and to establish predictors of worse cardiac function such as viral burden and ART~     regimen. These studies are critically important as earlier diagnosis and intervention~     represent the best means to alter the course of HIV-associated cardiomyopathy.~      Objectives: To determine the association of biomarker levels, myocardial deformation, and~     viral load level history in HIV infected children attending Moi Teaching and Referral~     Hospital (MTRH) clinic.~      Design: A cross-sectional study on clients attending HIV clinic, MTRH. Setting: Module 4 HIV~     clinic at MTRH in western Kenya, Africa. Population: HIV-infected children attending clinic~     in 2017 - 2018 Main Measures: Echocardiographic function assessment, Age, Immune status,~     other illnesses, ART status.~      Conclusions: The study will explore the NIH/HIV High Priority Target area of HIV-associated~     cardiac co-morbidities and will enhance understanding of the relationship between cardiac~     function and viremia. The investigators expect to be able to reliably define a subset of~     children with worse cardiac function by risk factors: specific ART regimens, less time~     virally suppressed, and increased BNP biomarker.~   "
25821|NCT03228953|"~     This is a two-arm double-blind prospective randomized controlled trial (RCT) to evaluate~     clinical impact of pharmacogenomic testing on the treatment of major depressive disorder.~     Participants will be randomly assigned to two groups: pharmacogenomic-guided therapy group~     (guided group) and treatment as usual group (TAU group). The primary hypothesis is the~     pharmacogenomic-guided treatment group will demonstrate significantly higher percent~     improvement in depression score compared to treatment-as-usual group.~   "
25822|NCT03228940|"~     Fabry Disease (FD) is a rare X-linked lysosomal storage disorder (LSD) caused by mutations in~     the GLA gene which translates into decreased activity or lack of function of the enzyme~     alpha-galactosidase A (α-GAL A) and accumulation of the enzymes substrate, i.e., Gb3,~     throughout the body. Cardiovascular and renal complications are among the leading causes of~     death in FD patients. RVX000222 is a BET inhibitor which modulates the expression of a~     variety of genes and, due to its effects on pathways downstream of substrate accumulation and~     reduction of major cardiac events, holds promise as a potential add-on therapy to accompany~     enzyme replacement therapy (ERT) in FD patients.~   "
25823|NCT03228927|"~     Questionnaires will be completed by each member of the twin set. A board-certified~     dermatologist will examine each member to categorize the type and severity of their rosacea.~     The facial and gut microbiome will be sampled and sent for microbial analysis.~   "
25824|NCT03228914|"~     The purpose of this study is to compare the effects of Oxymetazoline and Epinephrine (which~     are 2 different nasal decongestants both of which are routinely used before sinus surgery) on~     blood loss and the surgeon's view of the surgical field during sinus surgery.~   "
25825|NCT03228901|"~     In this protocol registration, the investigators plan a secondary data analysis of a dataset~     to explore the effects of intra-nasal oxytocin on the non-verbal expression of affiliation.~   "
25826|NCT03228888|"~     The use of rhythmic auditory stimulation (RAS) has been proven useful in the management of~     gait disturbances induced by Parkinson's disease (PD). Typically, the stimuli used to provide~     RAS consist of metronome or music-based sounds, which are not related with the auditory~     experience of walking. Based on previous laboratory research, it is hypothesized that the use~     of ecological sounds deriving from biological motion (i.e., footstep sounds) could have a~     greater impact compared to artificial sounds (i.e., metronome sounds), within a~     rehabilitation program. In a double-blind experiment, it was investigated the effects of 5~     weeks of supervised rehabilitation integrated with RAS. Thirty-two individuals affected by PD~     (age 68.2 ± 10.5, Hoehn and Yahr 1,5-3) were randomly assigned to one of the two conditions~     (artificial vs. ecological sounds). Spatio-temporal parameters of gait and clinical variables~     were assessed before the rehabilitation period, at its end, and after a 3-month follow-up.~     The results revealed that the rehabilitation program integrated with RAS had positive effects~     on the majority of objective and subjective measures, independently of the type of sound.~     However, when the two groups were examined separately, the patients assigned to the~     ecological RAS condition were the only who improved both in terms of cadence and gait speed.~     Overall, the hypothesized greater effect of the ecological sounds compared to artificial~     sounds was only partially supported by data.~   "
25827|NCT03228875|"~     Early life exposures may lead to adverse effects on health in later life. The Boston birth~     Cohort study is designed to study a broad array of early life factors and their effects on~     pregnancy, infancy, and child health outcomes.~   "
25828|NCT03228862|"~     To investigate the optimal initial and maintenance doses of vitamin D2 supplementation for~     the treatment of vitamin D insufficiency in Thai adults, and to determine the prevalence of~     and risk factors for hypovitaminosis D among Thai adults.~   "
25829|NCT03228849|"~     This study aims to compare conservative treatment versus a new suture anchor technique for~     bony mallet finger in 29 patients.~   "
25830|NCT03228836|"~     This is phase II study. Efficacy and safety evaluation of IBI308 in patients with~     relapsed/refractory extranodal NK/T cell lymphoma, nasal type: a multicenter, single arm.~   "
25840|NCT03228706|"~     Poor medication adherence (MA) among Type 2 Diabetes Mellitus (T2DM) patients had found to be~     gnarly and devastating (Krass et al 2015; Sharma et al 2014). It was estimated that more than~     half of the patients failed to achieve recommended glycaemic goals due to nonadherence~     (García-Pérez 2013; World Health Organization 2003). Furthermore, greater adherence rate was~     significantly associated with better glycemic control, fewer hospital visits and admissions,~     and lower medical costs. On the other hand, lower adherence rate was significantly associated~     with poor medication tolerance, the frequency of medication intake (> 2 times a day), having~     concomitant depression and negative belief about the medications. Consequently, patients who~     poorly adhere to medications would take more medications due to the poor glycemic control and~     development of micro- and macrovascular complications (American Diabetes Association 2013).~     Such condition would further worsen their adherence due to more complex medications and a~     greater chance of experiencing drug-related side effects (García-Pérez 2013). This inevitably~     increases the economic burden and wastage to the healthcare system (Meng et al 2017). Hence~     breaking the vicious cycle is an urgent call to all stakeholders.~      Notably, Ministry of Health Malaysia (MOH) had initiated several interventions in curbing the~     MA problems at national level. One of those which has been perpetuated and led by pharmacists~     is Know Your Medicine (KYM) Campaign since 2007. The national KYM campaign aims to promote~     the quality use of medicines through mass communication and group-based approach. The~     messages conveyed include information on their medication management such as why, how and~     when to take medicines, reporting adverse drug events, awareness on the rational use of~     medicines and medications that need special precautions. In specific, assuring and improving~     medication adherence among patients is one of the important components of the campaign (PSD~     2008).~      In term of improving medication adherence among Malay T2DM patients, a structured group-based~     intervention (SGBI) called Know Your Medicine - Take It For Health with abbreviation~     KYM-TIGF, was created by the researchers of this study who work at Sarawak Pharmaceutical~     Services Division in 2016 under the KYM campaign. The KYM-TIGF is a theoretical based,~     patient empowerment, culturally appropriate and a combination of psychosocial, educational~     and behavioral intervention. It is a one-off SGBI that aims to improve the medication~     adherence through the message specially designed with a cross-theoretical framework as~     recommended by Slater (1999). The model to measure the effectiveness of the SGBI is an~     integrated model with Theory of Planned Behaviour (Ajzen 1991) as main theory and~     Information-Motivation-Behavioural Skills Model (Fisher et al. 2006) as supporting theory.~     The primary outcome of this study is the medication adherence level. The secondary outcomes~     of this study are the psychosocial variables of the integrated model which include attitude~     to medication adhere, the subjective norm to medication adherence, perceived behavioral~     control towards medication adherence, adherence information, adherence skill and intention to~     adhere.~   "
25841|NCT03228693|"~     This study aims to examine both the genetic profile and the biomarkers implicated in keloid~     scar formation.~      Hypothesis:~        1. Differences in the genetic profiles of lesional and non-lesional skin contribute a given~          population's propensity to develop keloids~        2. Differences in biomolecules expressed in subjects with and without keloids can help~          predict keloid occurrence and severity~        3. Biomarker analysis will provide useful insights for future targeted therapies for keloid~          scars~   "
25842|NCT03228680|"~     To demonstrate non-inferiority of FE 999049 compared to FOLLISTIM with respect to number of~     oocytes retrieved in Japanese IVF/ICSI patients undergoing controlled ovarian stimulation~   "
28152|NCT03198494|"~     The objective of this study is to test the feasibility and physiological effect of~     low-frequency (1 Hz) acoustic stimulation delivered during nocturnal NREM sleep in epilepsy~     patients. The long-term goal is to develop this protocol for daily, long-term use in a home~     setting, for nocturnal seizure and IED suppression~   "
25831|NCT03228823|"~     Premature ventricular contractions (PVCs) coexist in patients with heart failure (HF) and LV~     dysfunction. Frequent PVCs have shown to induce a reversible cardiomyopathy (PVC-CM).~      This clinical pilot study will enroll 36 patients with frequent PVCs (burden >10%) and CM~     (LVEF <45%) and randomize them to either: 1) RFA or 2) AADs. Prior to treatment, patients~     will undergo a baseline cardiac MR if clinically indicated followed by 3-month observation~     period (optimal HF medical therapy). Changes in LV function/scar, PVC burden/arrhythmias and~     clinical/functional status (QOL, HF symptoms and admissions, NYHA class) and adverse events~     will be assessed throughout the observation period and compare with PVC suppression~     strategies (RFA or AAD). Similar comparison will be made between RFA and AAD treatment groups~     during a 12-month follow up using a Prospective Randomized Open, Blinded End-point (PROBE)~     study design. The treatment regimens will be compared in an intention-to-treat analysis. In~     addition, a total of 20,000 consecutive ambulatory ECG Holter monitors from all participating~     centers will be screened to identify all patients with probable diagnosis of PVC-CM.~      This pilot study is intended to estimate the prevalence of this clinical entity and pave the~     way for a large full scale randomized trial to identify best treatment strategy for patients~     with PVC-CM. Treating and reversing this underestimated PVC-CM may improve patient's health~     and subsequently decrease HF healthcare spending.~   "
25832|NCT03228810|"~     Biomarkers from circulating cell-free tumor DNA in peripheral blood will identify patients~     with metastatic prostate cancer diagnosed with C11 choline PET/CT who will benefit from~     metastasis-directed radiation, ablative therapies, and/or surgery. Tissue and blood will be~     collected before treatment. If patients receive androgen deprivation, then blood will be~     collected after neoadjuvant androgen deprivation but before radiation, ablative therapies, or~     surgery. Subsequent samples will be obtained at 3 months and 6 months following treatment,~     after which no further patient contact will occur.~   "
25833|NCT03228797|"~     aim of this study is to compare the postoperative analgesia provided bya continuous~     preperitoneal infusion versus ultrasound guided rectus sheath block for midline emergency~     laparotomy.~      anticoagulated patients~   "
25834|NCT03228784|"~     The study tried to find the relation between ablation depth and degree of dryness after LASIK~     treatment of myopic patients~   "
25835|NCT03228771|"~     Despite the numerous studies describing the benefits of PRGF (plasma rich in growth factors)~     and Statins separately , there has been a lack of clinical investigation into the~     simultaneous use of these agents in socket augmentation. Therefore the main objective of this~     study is to evaluate socket bone dimensions and quality following the use of PRGF derived~     fibrin scaffold as a carrier for Atorvastatin in socket augmentation clinically and~     histomorphometrically.~   "
25836|NCT03228758|"~     The purpose of this study is to compare the safety and efficacy of the anterior versus~     posterior myotomy technique in Per Oral Endoscopic Myotomy (POEM) for the treatment of~     Achalasia. The primary efficacy outcome is periprocedural pain requiring the use of~     narcotics. The secondary outcomes focus on safety which includes technical procedure duration~     time; tunneling time, myotomy time, and closure time; incidence of mucosotomy (transmural and~     non-transmural injury), capnoperitoneum, and the postoperative sequelae of gastrointestinal~     reflux disease (GERD). Periprocedural pain data collection will include post POEM procedure~     pain scores, administrations of analgesia until discharge.~      The final analysis will focus on determining whether there is a statistically significant~     difference in the amount and severity of pain in the Anterior versus Posterior myotomy~     subject populations. Additional analysis will be the collection of analgesic type (narcotic~     versus non-narcotic), dosage, frequency, and duration of treatment from post POEM procedure~     in the endoscopy recovery suite until the subjects are discharged.~   "
25837|NCT03228745|"~     Despite surgical success of total knee arthroplasty (TKA), reports of dissatisfaction and~     poor outcomes including increased pain, reduced function for daily activities, and~     compromised psychological health are common. Interventions to improve TKA outcomes are~     primarily education-focused, however there is little support for efficacy. Evidence suggests~     that mindfulness based stress reduction (MBSR) is effective for improving both physical and~     mental health, which are factors implicated in negative post-operative TKA outcomes. The~     efficacy of this empirically supported intervention on TKA outcomes has not been assessed.~     The proposed pilot study will conduct a randomized controlled trial to evaluate the~     feasibility and efficacy of pre-surgical MBSR on post-surgical outcomes. Post-operative pain~     (severity and catastrophizing), functioning (interference and illness impact), quality of~     life, emotional distress (anxiety and depression) and sleep will be assessed in pre-surgical~     MBSR and compared to treatment as usual. This pilot will provide an opportunity for TKA~     patients to receive an intervention that may improve outcomes. Further, it will provide~     insight into the relationship between pre-surgical MBSR and post-operative TKA outcomes,~     which will assist in the development of MBSR adaptations to less time intensive, and~     potentially more accessible, future offerings.~   "
25838|NCT03228732|"~     (1) To determine how the Selective Serotonin Reuptake Inhibitor (SSRI), fluoxetine (Prozac),~     an antidepressant often used to treat depression, stimulates the participant's body's ability~     to defend against low blood sugar (hypoglycemia). (2) To learn how a hormone,~     dehydroepiandrosterone (DHEA), stimulates the participant's body's ability to defend itself~     from low blood sugar (hypoglycemia). DHEA is a hormone produced naturally in the human body.~     However, it can be manufactured and is sold as an over-the-counter dietary supplement. The~     dose the investigators are giving in this study is higher than the usual recommended dosage~     taken as a supplement for certain medical conditions. (3) To study combined effects of~     fluoxetine and DHEA during low blood glucose. In the present study, the investigators will~     measure the participant's body's responses to hypoglycemia when given fluoxetine or DHEA or~     fluoxetine and DHEA or a placebo (a pill with no fluoxetine or DHEA). Approximately 64~     individuals with type 1 diabetes will take part in this study.~   "
25844|NCT03228654|"~     Hysterectomy is one of the most common surgical procedures in gynecologic practice. Inspiteof~     the development of alternative treatments, the incidence of hysterectomy doesn't appear to be~     declining. Routes for hysterectomy include abdominal, vaginal, laparoscopic or combined~     approaches.Vaginal hysterectomy is the method of choice for removal of the uterus in patients~     with benign gynecological diseases. A Cochrane review of surgical approaches to hysterectomy~     for benign gynecological diseases concluded that, wee possible vaginal hysterectomy should be~     performed in preference to abdominal hysterectomy.~   "
25847|NCT03228615|"~     The purpose of this clinical trial is to implement a multi-component shared decision making~     intervention for families of children with IBD. The main objective of this research will be~     to assess the acceptability, feasibility and clinical and decision outcomes of a~     multi-component decision support intervention targeted at families of children with IBD who~     are making decisions about treatment with TNFαi agents.~   "
25848|NCT03228602|"~     The aim of the study is to compare several parameters in three distinct groups of subjects:~     persons with obesity, persons with obesity and diabetes and persons with neither obesity nor~     diabetes:~        -  the electrical activity in response to a sweet solution, measured before and after a~          standard meal, using gustatory evoked potentials (recording explained below)~        -  blood hormone levels related to weight gain (insulin, dopamine, ghrelin, leptin:~          measured in blood samples)~        -  levels of activity and quantity of an enzyme present in the saliva, amylase, which is~          able to break down ingested starch into several molecules of glucose.~      All of these parameters will be correlated to determine whether the results are different in~     the 3 groups of subjects in the study.~   "
25849|NCT03228589|"~     This trial is a single-site, randomised, double-blind, placebo-controlled, two-armed,~     parallel-group trial in healthy, adult volunteers. The trial will investigate the effect of~     daily intake of a probiotic strain versus placebo when co-administered to daily intake of~     300mg of Aspirin. The objective is to investigate the ability of the probiotic strain to~     attenuate and/or reverse Aspirin-induced deterioration of the small intestine.~   "
25850|NCT03228576|"~     The tacrolimus-Everolimus association is used as an immunospressive treatment after a kidney~     transplant. It combined immunosupressive properties of both products and reduce the~     nephrotoxicity of tacrolimus by lowering the dosage.~      The commercialisation of a new extended release Tacrolimus pharmaceutical form and the lack~     of information justify a modality of use and tolerence evaluation of this new association,~     commonly used.~   "
25851|NCT03228563|"~     Probiotics could improve renal function parameters in uremic rats and significantly lower~     levels of blood urea nitrogen in stage 3 and 4 chronic kidney disease patients. The aim of~     the present study is to evaluate whether probiotics could retard the decline of renal~     function in patients with chronic kidney disease?~   "
25852|NCT03228550|"~     The study will provide insight into how lifestyle-related interventions, specifically~     nutrition and exercise can impact the health of older women. The study uses a unique~     combination of interventions and encapsulates overall health outcomes by measuring both~     mobility and cognitive function.~      The study examines the effects of a combined omega-3 polyunsaturated fatty acid (PUFA) and~     multi-nutrient supplement on measures of mobility and cognition in women aged 60 years and~     above. Volunteers for the study will be randomly assigned to one of four groups which are as~     follows:~        -  Omega-3 PUFA multi-nutrient supplement and aerobic exercise~        -  Omega-3 PUFA multi-nutrient supplement and no exercise~        -  Placebo supplement and aerobic exercise~        -  Placebo supplement and no exercise~      Volunteers undertake the dietary supplementation for a period of 24 weeks. The active dietary~     supplement contains a daily dosage of 1 g docosahexaenoic acid, 160 mg eicosapentaenoic acid,~     240 mg Ginkgo biloba, 60 mg phosphatidylserine, 20 mg d-α tocopherol, 1 mg folic acid, and 20~     µg vitamin B12. The placebo supplement contains an iso-calorific oil blend that is typical of~     the current UK diet. The aerobic exercise consists of two classes per week the final 12 weeks~     of the study on stationary spinning exercise bikes.~      Volunteers attend testing at the beginning and after 24 weeks. Verbal memory, spatial working~     memory, executive function and processing speed are assessed via a battery of cognitive~     tests. Mobility testing comprises three walking tests, some under single and dual task~     paradigms, as well as the five times sit to stand test, a measure of dynamic balance and~     functional mobility. Volunteers also provide two blood samples, one for fatty acids analysis~     and the other serum homocysteine levels. Participants also complete health-related quality of~     life questionnaire, the short form 36 (SF36) questionnaire, food diary and food frequency~     questionnaire.~   "
25853|NCT03228537|"~     This phase I pilot trial studies how well atezolizumab, pemetrexed disodium, cisplatin, and~     surgery with or without radiation therapy in treating patients with stage I-III pleural~     malignant mesothelioma. Monoclonal antibodies, such as atezolizumab, may interfere with the~     ability of tumor cells to grow and spread. Pemetrexed disodium may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy,~     such as cisplatin, work in different ways to stop the growth of tumor cells, either by~     killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving~     atezolizumab, pemetrexed disodium, and cisplatin before surgery may make the tumor smaller~     and reduce the amount of normal tissue that needs to be removed. Giving atezolizumab after~     surgery may kill any remaining tumor cells.~   "
25854|NCT03228524|"~     An important mechanism responsible for clinical recovery after neurological damage of~     different types is synaptic plasticity. Nervous tissue can enhance or de-energize~     inter-neuronal transmission at synaptic level in a lasting way. By increasing the efficiency~     of synaptic transmission, through long-term potentiation (LTP), it is possible to compensate~     for the loss of synaptic pulses on survived neurons due to brain damage and to restore their~     function.~      At synaptic level, LTP is mainly regulated by NMDA receptors. In animal models induction of~     plasticity in surviving neurons through the stimulation of NMDA receptors has been shown to~     limit the clinical manifestations of neuronal damage. Endogenous NMDA is synthesized by~     methylation of D-aspartate (Asp) by D-aspartatoartate methyltransferase . Moreover, Asp acts~     as a neurotransmitter capable of activating the NMDA receptor, since its biosynthesis,~     degradation, absorption and release occurs in the pre-synaptic neuron, and its release~     determines a response in Post-synaptic neurons. The expression of Asp in the SNC is very~     abundant during the embryonic period and in early years, whereas it is significantly reduced~     in adulthood.~      Consistent with Asp ability of activating the NMDA receptor, recent studies have shown that~     oral administration of Asp increases LTP induction in mice. Preliminary studies by our group~     also showed an increase in LTP amplitude in subjects suffering from progressive forms of~     Multiple Sclerosis after 2 weeks of daily per os intake of 2660mg Asp.~      It is also well known that the therapeutic exercise that characterizes a rehabilitative~     treatment is able to induce various benefits to the physical-functional and the~     cognitive-emotional spheres. In this regard, it has been extensively demonstrated how~     repeatedly performing a motor task can increase cortical excitability through the induction~     of LTP mechanisms.~      Hypothesis Pharmacologically promoting the induction of cortical LTP by the intake of Asp in~     subjects with various types of brain damage (eg Multiple Sclerosis, Parkinson's Disease,~     Dementia) may favor the therapeutic effects of rehabilitative treatment.~      Specific Objectives Evaluate the effects of Asp in improving the outcome of rehabilitative~     treatment resulting from brain damage of different origin.~   "
25855|NCT03228511|"~     It is a Prospective descriptive hospital based clinical study to determine the value of~     introduction of endoscope after microscopic excision of cerebello-pontine angle lesions to~     estimate the following :~        1. Intraoperative judgement of lesions excision, residual parts, visualization and~          operative corridor pre and after endoscope introduction.~        2. Post-operative tumor control confirmed comparison between pre and postoperative MRI.~        3. Postoperative complications, advantages and disadvantages compared with these when use~          pure microscopic excision from the literature~   "
25856|NCT03228498|"~     The purpose of this study is to assess whether the combination of choline alphoscerate 1200mg~     per day and nimodipine 90mg per day given orally is more effective than the combination~     nimodipine placebo in reducing cognitive decline in patients with subcortical vascular~     cognitive impairment~   "
25857|NCT03228485|"~     This study assesses the feasibility, and acceptability of a (mobile) application for men~     presenting at the general practitioner with LUTS/BPH; starting with medical therapy and naïve~     for treatment. Patients will be enrolled in the study by their general practitioner. The~     patients will receive a daily medication reminder including frequent feedback on medication~     adherence. Furthermore standard questionnaires will be filled out via the application. The~     hypothesis of this pilot study is that application is feasible and accepted in this group of~     patients.~   "
25858|NCT03228472|"~     Non-invasive cerebral stimulation techniques have shown potential in the treatment of~     neurological disorders such as chronic pain, Parkinson's disease, neglect, aphasia, memory,~     engine deficit and epilepsy In general, non-invasive cerebral stimulation techniques have~     been shown to be able to induce changes in cortical plasticity that may last even beyond the~     end of the stimulation period. Considering this potential, there is growing interest in the~     application of these therapeutic techniques.~      Hypotheses Based on these assumptions, the underlying hypothesis behind this project is that~     the therapeutic use of cranial - electrical or magnetic stimulation - can aid the recovery of~     various brain injury symptoms.~      Specific objectives This study aims to provide preliminary data about the benefits of using~     cortical stimulation to recover various brain injury symptoms. This will be made possible~     thanks to the specific skills of a multidisciplinary team of neurologists and physiatrists,~     healthcare professionals such as physiotherapists, occupational therapists, psychologists,~     speech therapists and the support of a biomedical engineer. These professional figures are~     already available at the UCK Neurosurgery of the IRCCS Neuromed directed by the proposer and~     actively collaborate to optimize the therapeutic exercise of patients with neurological~     damage.~   "
25859|NCT03228459|"~     Background and Objectives: Chronic kidney disease (CKD) and atherosclerosis are 2~     interrelated diseases that increase the risk of cardiovascular morbidity and mortality. The~     objectives of the ILERVAS project are: (1) to determine the prevalence of subclinical~     arterial disease and hidden kidney disease; (2) to assess the impact of early diagnosis of~     both diseases on cardiovascular morbidity and mortality and also on the progression of CKD;~     (3) to have a platform with clinical data, vascular imaging and biological samples to define~     a personalized cardiovascular risk profile.~      Methods: Randomized intervention study. From 2015 to 2017, 14,600 people (7,300 in the~     intervention group and 7,300 in the control group) aged between 45 and 70 years without a~     previous history of cardiovascular disease and with at least one cardiovascular risk factor~     will be randomly selected from the primary health care centers across the province of Lleida,~     Spain. A team of experts will travel around in a mobile unit to carry out the following~     baseline tests on the intervention group: artery ultrasound (carotid, femoral, transcranial~     and abdominal aorta), ankle-brachial index, spirometry, determination of advanced glycation~     end products, atrial fibrillation screening, dried blood spot and urine spot tests.~     Additionally, blood and urine samples will be collected and stored in the biobank to identify~     new biomarkers using omics studies. Participants will be followed up until 2027 to assess~     whether the intervention group has any changes on medical treatments and lifestyle changes.~     In addition, the incidence of cardiovascular events will be compared between the intervention~     and control groups.~   "
25860|NCT03228446|"~     The investigators are interested in how attentional filter training/ distractor inhibition~     training could influence cognitive functions like working memory, executive control, problem~     solving, decision making and attentional control.~   "
25861|NCT03228433|"~     The purpose of this study is to evaluate the safety and tolerability of TAK-418 following~     single oral doses in healthy participants.~   "
25862|NCT03228420|"~     This post-market study is being conducted to document comparative safety, clinical~     effectiveness, and cost-effectiveness of the addition of HF10™ therapy to CMM compared with~     CMM alone in subjects with chronic, intractable, neuropathic lower limb pain due to diabetic~     neuropathy (Painful Diabetic Neuropathy or PDN). This study is a multi-center, prospective,~     randomized comparison of the two treatments.~   "
25863|NCT03228407|"~     Confocal Endomicroscopy for Permeability of Esophageal Wall in Refractory Gastroesophageal~     Reflux Disease (GERD)~   "
25864|NCT03228394|"~     This study will evaluate the Safety, Pharmacokinetics and Efficacy of IV Administration of~     Ganaxolone in Women with Postpartum Depression~   "
25865|NCT03228381|"~     The objective of the BOSS Study is to assess acute anatomical and geometric annular and~     ventricular changes that occur when strategically positioned an external inflatable chambers~     are applied to the outside of the heart.~   "
25866|NCT03228368|"~     This study is designed to evaluate the predicted potential of quantitative T cell repertoire~     (TCR) of T cell receptor chains using next-generation sequencing (NGS) in the treatment of~     the anti-programmed death-ligand 1 (PD-L1) antibody atezolizumab in participants with locally~     advanced or metastatic NSCLC who have progressed during or following a platinum-containing~     regimen. Treatment may continue until disease progression or unacceptable toxicity.~   "
25867|NCT03228355|"~     To investigate the role of KATP channels on the cerebral hemodynamic in migraine patients.~   "
25868|NCT03228342|"~     Evaluate the impact of MusculoSkeletal Ultrasound added to Rheumatoid Arthritis patients~     classified in remission/low disease activity in terms of Patient Reported Outcomes.~   "
25869|NCT03228329|"~     aim of our study to validate electrical cardiometry readings against same readings by~     transoesophageal echo. we will validate stroke volume (SV) readings stroke volume~     variation(SVV), index of contractility.~   "
25870|NCT03228316|"~     Cancer-related pain represents a major challenge for both clinicians and patients. This pain~     can be associated directly with the cancer or with certain treatments administered to the~     patient. 52.1% of cancer patients suffer from pain and that 62.6% are not satisfied with the~     current pain treatment. Pain prevalence is high in developing countries due to late diagnosis~     and major impediments to opioid access~   "
25871|NCT03228303|"~     Nilotinib vs imatinib in patients with newly diagnosed CML-CP~   "
25872|NCT03228290|"~     This will be a prospective cohort study of patients with cirrhosis who are listed for liver~     transplantation. Subjects will undergo geriatric assessments of frailty, functional status,~     and disability using functional status measures at baseline and at every clinic visit in the~     pre-transplant setting. Subjects will again undergo functional assessments at every clinic~     visit through 12 months after transplant.~   "
25874|NCT03228264|"~     The aim of this study is to investigate the effects of high-frequency short duration~     tablet-based speech and language therapy (teleSLT) mixed with cognitive training (teleCT) in~     chronic stroke patients. Recent studies suggest that chronic stroke patients benefit from SLT~     with high frequency and that cognitive abilities can play a role in sentence comprehension~     and production by individuals with aphasia. To investigate the effects of the distribution of~     training time for teleSLT and teleCT the investigators use two combinations. In the~     experimental group 80% of the training time will be devoted to teleSLT and 20% to teleCT~     whereas in the control group 20% of the training time will be devoted to teleSLT and 80% to~     teleCT. Both groups receive the same total amount and frequency of intervention but with~     different distributions. At three time points (pre-, post-test and 8 week follow-up) the~     patients' word finding ability is measured.~   "
25875|NCT03228251|"~     Acute stroke care is highly time critical for thrombolysis as well as thrombectomy. In both~     scenarios, each minute lost reduces the therapeutic efficacy. Therefore, an optimal~     implementation of these effective therapies into daily clinical practice is of utmost~     importance for the translation of the evidence from clinical trials into good clinical~     outcomes in routine care. In acute stroke therapy, the patient is cared for by an~     interdisciplinary team and often has to undergo several handovers between different~     caregivers with possible interface problems.~      To facilitate a smooth workflow, the investigator developed an interdisciplinary stroke team~     algorithm and implemented regular simulation-based team trainings at the investigators~     institution. This multimodal intervention markedly improved the door-to-needle time for~     thrombolysis (time from the patient's arrival in the emergency department to the start of the~     tissue plasminogen activator (tPA) infusion) which is the most relevant benchmark parameter~     for acute stroke care. The investigators monthly stroke team training had a positive effect~     on the perceived degree of safety and staff satisfaction among the employees of the~     investigators departments.~      The investigator plans to investigate the benefits of the multimodal intervention of a stroke~     team algorithm with regular stroke team simulation training in a controlled prospective~     pretest-posttest trial design at seven leading stroke centers in Germany. The investigator~     hypothesize that the implementation of a stroke team algorithm (defined team, defined tasks)~     and regular stroke team training with a focus on efficient team work and communication will~     improve process times, patient safety and staff satisfaction.~      In the pretest period, the participating seven centers (tertiary care university hospitals~     with thrombectomy capacity 24/7/365) record the data of all consecutive patients receiving~     thrombolysis and/or thrombectomy during a three month period. Afterwards 3-4 leading~     employees of different professional backgrounds (e.g. senior neurologist of the stroke unit,~     neurointerventionalist, head nurse of emergency department) will be invited to a joint~     train-the-trainer seminar at the sponsors institution where the participating centers~     present their algorithm to the participants of all seven stroke centers for discussion to~     invite suggestions for streamlining and improvement and a train-the-trainer course of stroke~     simulation. After the seminar, the principal investigator and stroke team trainer will visit~     all centers for one in situ stroke team simulation training and provide teaching materials.~     Afterwards, each center will be invited to schedule two additional stroke team trainings a~     with stroke team trainer that will be led by e.g. the senior neurologist from the respective~     stroke unit with the aim of permanently starting up regular stroke team simulation. In the~     posttest period, the participating seven centers again record the data of all consecutive~     patients receiving thrombolysis and/or thrombectomy during a three month time period.~   "
25876|NCT03228238|"~     Purpose Objectives~        1. To evaluate the anti-oxidant effect of long-term Vitamin C+E therapy on coronary~          vasospasm improvement.~        2. To evaluate the anti-oxidant effect of long-term statin therapy on coronary vasospasm~          improvement.~        3. To evaluate the effect of long-term Vitamin C+E and statin therapy on regression of~          atheroma in target coronary vessels via intravascular ultrasound.~        4. To find out the role of vascular endothelium in variant angina via evaluating long-term~          Vitamin C+E and statin therapy on improvement in vascular endothelial function by~          assessing brachial arterial expansion capability.~        5. To find out the role of vascular endothelium in variant angina via evaluating long-term~          Vitamin C+E and statin therapy on improvement in arterial stiffness by assessing pulse~          wave velocity(PWV)~   "
25877|NCT03228225|"~     We aim to enroll subjects eligible to cardiac rehabilitation that are defined as low-risk~     according to national guidelines. We plan to gradually reduce the number of institution based~     CR and increase the tele monitored exercise sessions performed in the community. Stress test~     will be preformed before the intervention and after completing 6 month.~   "
25878|NCT03228212|"~     This study is a randomized, 5-visit, partial subject masked, 2x3 bilateral crossover,~     dispensing clinical trial. During the study, each test article will be worn in a daily wear~     modality for at least 6 hours per day and 5 days per week for approximately 2 weeks each. The~     subject will wear either the Test or Control article twice and the other study article once.~     The primary objective of this study is to demonstrate that the Test lens works as well, if~     not better compared to the Control lens with respect to CLUE (Contact Lens User Experience)~     comfort, Slit Lamp findings, and Distance Monocular logMAR Visual Acuity. This study will~     also aim to show acceptable lens fit for subjects wearing the Test lens.~   "
25879|NCT03228199|"~     This trial seeks to establish, using a randomized, controlled design, the impact of near~     eyesight correction on the productivity of presbyopic agricultural workers in India, as~     measured by weight of tea picked.~   "
25880|NCT03228186|"~     This study is a single institution Phase II single arm trial to assess the efficacy of the~     combination of pevonedistat plus docetaxel in patients with previously treated advanced NSCLC~     (non-small cell lung cancer).~   "
25881|NCT03228173|"~     This study aims to examine iron deficiency symptoms and biochemical iron status based on~     hemoglobin, hematocrit, ferritin, and total iron binding capacity in menstruating females.~   "
25882|NCT03228160|"~     Background. Sympathetically maintained pain (SMP) can be effectively relieved by light~     irradiation to the area near stellate ganglion (SGI), which is applied as an alternative to~     sympathetic blockade. The clinical efficiency of SGI on heart rate variability (HRV) and its~     association with pain outcome need to be further identified.~      Objectives. This study is aimed to identify the effects of SGI on pain, HRV indices, quality~     of life, and function outcomes.~      Design. A prospective, double blind, randomized designed study Setting. An outpatient pain~     medicine clinic Subjects and Methods. A total of 44 patients will be enrolled and randomized~     to their allocations: the experimental group (EG, n=22) and control group (CG, n=22). All~     patients in EG will receive 12 sessions (twice a week) of standard SGI, while those in CG go~     through the same protocol except a shame irradiation is applied. Pain, HRV variables, quality~     of life, and function outcoms are measured before and after SGI in each session. All measures~     at the first-half and second-half courses are analyzed.~   "
25883|NCT03228147|"~     This pilot clinical trial studies sensory evaluation of oral nutrition supplements in~     patients at risk for mucositis undergoing cancer treatment. Sensory evaluation may help to~     obtain input about new oral nutritional supplements that may increase nutrient intake and~     maintain or improve nutritional status, functional capacity, and quality of life in cancer~     patients.~   "
25884|NCT03228134|"~     Investigators aimed to evaluate the clinical efficacy of integrated traditional Chinese and~     Western medicine in the treatment of asthma, and to further optimize the prescription of~     Chinese medicine treatment.~   "
25885|NCT03228121|"~     The aim of this randomized, controlled crossover designed study is to compare the outcomes of~     receiving autologous, adult stem cells versus placebo among participants with chronic~     obstructive pulmonary disease (COPD). The study is limited to self-funded participants with a~     diagnosis of COPD. The study, along with others at the Lung Institute, have received full~     review and approval of an Institutional Review Board.~   "
25886|NCT03228108|"~     This study aims to assess the effectiveness and cost-effectiveness of rectal swab~     culture-guided antimicrobial prophylaxis to reduce infectious complications after transrectal~     prostate biopsy. Half of participants will receive routine empirical prophylaxis with oral~     ciprofloxacin (control group), while the other half will receive rectal culture-guided oral~     antibiotic prophylaxis (intervention group). In the intervention group, men whose rectal~     swabs do not show ciprofloxacin-resistant bacteria will receive ciprofloxacin prophylaxis,~     comparable to the control group. In case of ciprofloxacin-resistant bacteria an alternative~     oral antibiotic based on the culture results will be prescribed~     (trimethoprim/sulfamethoxazole, fosfomycin or pivmecillinam/augmentin).~      The investigators hypothesise that the targeted prophylaxis group (intervention group) will~     have a lower rate of post-biopsy infectious complications compared to the control group.~   "
25887|NCT03228095|"~     Detection of Volatile Organic Compounds (VOC) directly from tissue by headspace analysis~     (skin, surgery material, other tissue) and exhaled breath is feasible using affordable~     user-friendly novel nano-chemo sensors that can accurately be used for screening and~     monitoring purpose~   "
25888|NCT03228082|"~     RATIONALE:~      Women with a previous history of preeclampsia (PE)/HELLP have a twofold higher risk of~     cardiovascular disease (CVD) and a fourfold increased risk to develop hypertension at a~     relative young age. In the latest 2016 ESC guidelines 'CVD prevention', previous PE has been~     acknowledged as a serious CVD risk factor in women. In clinical practice, however, these~     women are still underappreciated for their CVD risk. It has not been established yet how~     adequate lifelong prevention in these potentially high risk women can optimally be achieved~     from their childbearing years onwards.~      OBJECTIVE:~      To evaluate feasibility, usability, acceptance and potential obstacles of blood pressure (BP)~     home monitoring in high-risk women, aged 40-60 years, after a previous PE in pregnancy. In~     addition to evaluate the effectiveness of BP home monitoring on the occurrence of~     hypertension, the efficacy of BP treatment, quality of life (QOL), health-related symptoms,~     work ability and life-style behaviour.~      STUDY DESIGN:~      Randomized, open label feasibility study to compare eHealth guided self management of BP~     monitoring and lifestyle advice with 'usual care'.~      STUDY POPULATION:~      Approximately 300 women, aged ≥ 40 and ≤ 60 years, with a previous PE in pregnancy will be~     invited to participate (both early and late PE). Patients will be recruited from the~     departments of obstetrics/gynaecology in 6 centres in the Euregio Rhein-Waal and from the~     department of cardiology Radboudumc.~      INTERVENTION:~      eHealth guided measurements of BP at regular intervals and recurrent lifestyle advice~     (intervention-group) will be compared with usual care.~      PRIMARY OUTCOME:~      Feasibility, usability, acceptance and potential obstacles of BP home monitoring in high-risk~     women after a previous PE in pregnancy at 1 year of follow-up.~   "
25889|NCT03228069|"~     To study the humoral and cell-mediated immune responses in HIV-infected adults who had~     previously received rabies booster vaccination more than a year before~   "
25890|NCT03228056|"~     This single-center, prospective, randomized controlled trial was designed to assess and~     compare the postoperative pain after VATS lobectomy performed though one, two and three~     incisions. The primary outcome measure is pain intensity measured in VAS scale. The secondary~     outcome measure is cumulative morphine consumption up to 72 hours after surgery~   "
25891|NCT03228043|"~     Objective: To compare the outcome of patients with colorectal cancer who treated with~     adjuvant therapy or Apatinib with adjuvant therapy postoperatively.~      Language: English.~   "
25892|NCT03228030|"~     Heart failure (HF) is a major cardiovascular disease with increasing prevalence. Thiamine~     deficiency is common in HF patients. Previous small studies have shown that thiamine~     supplementation can improve left ventricular systolic function in HF, but larger clinical~     studies are lacking. Given the ease of supplementation and the potential benefits in HF, we~     aim to conduct a pilot randomized controlled trial (RCT) using high dose thiamine~     supplementation in HF patients. The main goal of this pilot study is to determine the~     feasibility of recruitment for an RCT of thiamine supplementation.~   "
25893|NCT03228017|"~     This study will look at how chronic inflammation seen in psoriatic disease translates into~     the increased atherosclerotic and thrombotic risk and how treatment reduces this CVD risk.~     The Aim of this study is to 1) Evaluate the association between moderate to severe psoriatic~     disease and measures of vascular function. 2) Evaluate the association between moderate to~     severe psoriatic disease and measures of thrombotic risk. 3) Understand how traditional~     medications used in cardiovascular disease (CVD) prevention such as aspirin and statins~     affect vascular function and thrombotic risk in those with moderate to severe psoriatic~     disease.~   "
25894|NCT03228004|"~     The purpose of this pilot study is to determine if training and support, combined with~     reminders to facilitate glucose data sharing with the diabetes care team in between clinic~     visits, can improve glycemic outcomes for patients ages 10-17 with type 1 diabetes who have~     HbA1c levels above target.~   "
25895|NCT03227991|"~     This study will determine the efficacy of Safety Planning Intervention (SPI) compared to~     receiving risk factors and warning sign information (RWI) in recent suicide attempters during~     the 6 months following an acute care visit on: (1) suicidal behaviors; (2) mental~     health/substance use treatment engagement; (3) suicide-related coping strategies; (4)~     suicidal ideation; and (5) use of means restriction.~   "
25896|NCT03227978|"~     Recent advances in thoracoscopic surgery have made it a commonly used technique for treating~     spontaneous pneumothoraces and preventing recurrence. The goal of surgical treatment is to~     find the offending bleb, remove it, and do some manipulation to encourage pleural symphysis.~     Methods of thoracoscopic pleural symphysis have included mechanical abrasion and instillation~     of chemical irritants. Each method reduces the rate of pneumothorax recurrence to a certain~     degree, but the recurrence rates after thoracoscopic surgery are widely varied in the~     literature. Although several articles show significantly lower rates, there are also articles~     demonstrating that the recurrence rates of pneumothorax after thoracoscopic surgery ranged~     between 5 and 12%, which are higher than the rates reported after open thoracotomy. It is~     suggested that a less intense pleural inflammatory reaction is induced by thoracoscopic~     procedure than by thoracotomy. Besides, post-pleurodesis severe pain and bleeding were~     encountered frequently. A potential alternative to increase the intensity of pleural~     inflammation and thereby prevent pneumothorax recurrence is film pleurodesis. Only few~     studies have been reported where more than one film pleurodesis has been tried, and the~     mechanism of film pleurodesis remains unclear.~      Poly-ε-caprolactone (PCL) is a FDA-approved biomaterial with a slow degradation time of~     approximately 24 months when degraded by hydrolysis only. Recently, some investigators~     combined PCL with other biomaterials such as chitosan, polyethylene glycol, hyaluronic acid~     to produce anti-adhesion barrier for clinical applications. However, only few studies report~     PCL only could provide anti-adhesion effect. In contrast to common complications of~     postoperative abdominal adhesions, adhesion (or pleurodesis) is an important therapeutic tool~     to control the incidence of recurrent pneumothorax. We suppose that if a biomaterial induces~     adhesion following abdominal surgery, perhaps it may be applied to pleurodesis tool for~     preventing recurrence of spontaneous pneumothorax. We hypothesized that PCL membrane-induced~     pleurodesis can be achieved intrapleurally.~   "
25897|NCT03227965|"~     Cancer is a well known complication about long term transplantation. Cancer outcomes are due~     to the immunosuppressive treatment that prevents transplanted people from rejection. By~     lowering the effectiveness of the immune system, immune cells are no longer able to seek and~     destroy cancer cells.~      The goal here is to study immunes cells population of people that were transplanted 10 years~     ago and are now treated either by a corticosteroid - azathioprine association, or only by~     cyclosporine A.~   "
25898|NCT03227952|"~     The purpose of this study is to investigate the effectiveness of low-intensity and prolonged~     vibrotactile sensory stimulation on symptom relieve in fibromyalgia patients.~   "
25899|NCT03227939|"~     This research is created for compare the difference of AHI variation between LSG and combined~     surgery on obstructive sleep apnea in obese patients , evaluate the risk of combined surgery~     and explore the correlative factor of the curative effect.~   "
25900|NCT03227926|"~     Open label, single-arm, multiple centers, Phase II trial. The trial has been designed to~     prove or disprove whether a third line rechallenge with panitumumab can achieve an objective~     response rate (ORR= CR+PR) of 30% or more in a population of RAS wild type mCRC patients~     selected on the basis of RAS extended clonal evolution in their plasma.~   "
25901|NCT03227913|"~     The aim of this study is to understand how dairy products enriched in minerals and proteins~     are broken down in the mouth. More specifically, investigators wish to evaluate the link~     between oral physiology (salivation and mastication) and formation of the food bolus during~     the consumption of enriched cheese, that is to say the way in which the food is broken down~     to be swallowed.~      The study will take place at the INRA in Dijon during 2 one-hour sessions spread over 4~     months. These two sessions will allow investigators to characterise the chewing behaviour of~     the subjects and their salivation, and the structure of the food bolus formed when eating the~     four products of the project.~      For each of the four foods in each session:~        -  Two samples of saliva will be taken~        -  A video will be made of subjects eating one of the study products~        -  Subjects will chew the study foods and spit them out.~   "
25902|NCT03227900|"~     World's population over 60 years old is increasing rapidly. It is expected that in 2050~     elderly population will be 22% of the total population, representing around 2 billion people.~     This situation means a rising in the incidence of elderly-related diseases, and thereby the~     need for long-term care. Reduction in body fat and weight are a common problem among the~     institutionalized elderly. Some factors that contribute to the anorexia of aging are~     decreased perception of hunger and increased satiation. This represents an increased risk of~     developing cachexia even during minor illnesses. The potentially severe consequences of~     anorexia of aging a greater understanding of the underlying mechanism of these changes is~     highly important. Intraesophageal and intragastric infusion of 20mg/kg lidocaine results in~     an increase in food intake in Wistar rats. All infusions were done 30 minutes before the~     start of the meal intake (meal consisted of mealworms). It may be possible to decrease~     satiation, increase hunger, and hence food intake in elderly individuals through gastric~     infusion of the anesthetics lidocaine or benzocaine. In the future this study could~     potentially contribute to improve food intake in elderly vulnerable of losing body weight.~     Therefore, the current study aims to investigate the effect of intragastric administration of~     lidocaine on food intake, satiety/satiation and gastrointestinal complaints.~   "
25903|NCT03227887|"~     The aim of this study is to understand how foods such as Sponge cake or Brioche are broken~     down in the mouth. More specifically, investigators wish to evaluate the link between oral~     physiology (salivation and mastication) and (i) formation of the food bolus during the~     consumption of Sponge cake or Brioche, that is to say the way in which the food is broken~     down to be swallowed (ii) mouthfeel during the consumption of Sponge cake or Brioche, meaning~     the sensations that participant feel when they eat these products.~      The study will take place at the INRA in Dijon during 7 one-hour sessions spread over 3~     months. The first session will allow us to characterise the chewing behaviour of the subjects~     and their salivation, and will enable us to train them in the instructions for the following~     sessions. The 6 other sessions will allow us to study the structure of the food bolus while~     being formed and the mouthfeel of the foods in the project.~      In the first session:~        -  Two samples of saliva will be taken~        -  A video will be made of subjects eating Sponge cake or Brioche~        -  Subjects will be trained in exercises for the following sessions - this will consist in~          chewing the study foods and spitting them out on the experimenter's signal.~      During the 6 other sessions, subjects will be asked to:~        -  Chew one of the study foods and spit it out on the signal of the experimenter.~        -  Evaluate the mouthfeel while eating Sponge cake or Brioche by answering different~          questions. This test will be done during 4 of the 6 sessions.~   "
25904|NCT03227874|"~     Metabolic syndrome is a combination of metabolic comorbidities associated with obesity, which~     include impaired glucose tolerance and regulation, hypertension, dyslipidemia, and increased~     cardiovascular disease risk. Metabolic syndrome is highly prevalent with the growing trend of~     obesity that characterizes the US, with 34% of adults 20 years of age and older meeting the~     criteria. The number of people with diabetes is expected to increase dramatically over the~     next decades, coinciding with rising obesity rates in many countries. Recent studies have~     highlighted the beneficial effects of apple and apple products in reducing the risk of~     chronic disease due to their rich content of fiber, nutrients and various phytochemicals. The~     primary objective of the proposed research is to determine the acute effect of consumption of~     240 kcal servings of dried apples versus a lowfat/high fiber muffin on blood glucose, serum~     insulin, and fullness (satiety). The secondary objective of the proposed research is to~     determine the acute effect of consumption of dried apple versus a low-fat muffin on various~     cognitive domains. As with any organ, the brain requires nutrients to build and maintain its~     structure and function, in order to perform in a harmonious manner and avoid damage from~     aging. Epidemiological, clinical and basic research studies suggest protective effects of~     several classes of nutrients against cognitive decline and risk of dementia. Twenty five male~     and female participants between the ages of 20-45 years with a body mass index (BMI) between~     18 and 25 will be recruited to participate in the study at San Diego State University. Each~     participant will consume both test foods, the dried apple and muffin, on two separate visits~     to the lab at least a week apart. The participants will come to each lab visit after a 10~     hour overnight fast. After arriving at the laboratory, the participant's will complete a~     cognitive pre-test (Concussion Vital Signs Test Battery) consisting of eight short cognitive~     tests on a computer. Next After arriving at the lab, blood samples will be collected from~     warmed hands by finger-prick into large (250 microliter) heparinized Natelson tubes to obtain~     an ample blood collection for analysis of baseline plasma concentrations of glucose and~     insulin. The participants will then be given 5 minutes to consume the test food. Subsequent~     finger-prick blood samples will be collected at 15, 30, 45, 60, 90 and 120 minutes. The~     participants will also rate their feelings of fullness on a visual scale prior to consumption~     of the test food and every 15 minutes for two hours after consumption. After the completion~     of the finger-prick blood samples and satiety questionnaires the participants will complete a~     cognitive post-test which will be a different version of the cognitive pre-test battery.~     Concentrations of glucose will be assessed by a handheld glucose monitor as well as an~     enzymatic kit. Insulin will be assessed by ELISA or radioimmunoassay. Differences in all~     dependent variables between the trials will be determined using a repeated measures ANOVA and~     followed post-hoc when appropriate using paired T-tests to take advantage of the higher~     statistical power provided by paired comparisons. Data will be reported as means +/- SD.~     Significance will be selected at an alpha level of P < 0.05. These data may be useful as~     finding a snack source that produces a lower glycemic response and a greater satiating effect~     could be valuable in dietary counseling for blood glucose maintenance. For the cognitive~     portion of this research, these data may be useful because there is considerable room for~     improvement and for expanding evidence-based knowledge on the link between nutrition and~     cognition.~   "
25905|NCT03227861|"~     The purpose of this study is to assess the efficacy of Darunavir/ Cobicistat/ Emtricitabine/~     Tenofovir Alafenamide (D/C/F/TAF) fixed-dose combination (FDC) in a Test and Treat model of~     care in newly diagnosed human immunodeficiency virus (HIV-1)-infected, treatment-naive~     participants as determined by the proportion of virologic responders defined as having~     (HIV)-1 ribonucleic acid (RNA) lesser than 50 copies per milliliter (copies/mL) at Week 48.~   "
25906|NCT03227848|"~     The differentiation between innocent and pathologic murmurs through traditional auscultation~     can often be challenging, which in the end makes the diagnosis strongly dependent on the~     clinitians experience and clinical expertise. With the development of technology it is now~     possible to help diagnose heart murmurs using computer aided auscultation systems (CAA).~     eMurmur is an investigational CAA system (not FDA approved) and the investigators hypothesize~     that it can distinguish between AHA class I (pathologic murmurs) and AHA class III heart~     sounds (innocent murmurs and/or no murmurs) with a sensitivity and specificity equal or~     better compared to a similar FDA approved CAA system on market.~   "
25942|NCT03227380|"~     The objective of this study is to determine whether stapling adversely affects the pulmonary~     parenchyma and the vascularisation of the adjacent segments. The aim of our work is to~     explore by thoracic densitometry with contrast the spared segments after stapling of the~     intersegmental plan following a thoracoscopic segmentectomy, 3 or 6 months post-surgery. the~     investigator will assess venous drainage and the arterial vascularisation of the remaining~     segments, possible modifications of the adjacent parenchyma and whether there is a defect of~     pleuro-pulmonary adhesion (residual pneumothorax).~   "
25907|NCT03227835|"~     After administration of intravascular iodinated contrast media Contrast-Induced Nephropathy~     (CIN), also known as Contrast-Induced Acute Kidney Injury (CIAKI), may occur. CIN/CI-AKI is~     associated with increased risk of dialysis and mortality. No treatment exists for CIN/CI-AKI,~     therefore the focus lies on prevention. Clinical practice guidelines for the prevention of~     CIN/CI-AKI exist and are implemented in most hospitals. Generally, intravascular volume~     expansion with normal saline is recommended as prophylaxis.~      Earlier this year the results of the AMACING study were published in The Lancet~     (NL47173.068.14/METC 14-2-006; Clinical Trials.gov NCT02106234;~     http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)30057-0/fulltext). These~     results show that for the greater part (>90%) of patients considered to be at risk of~     CIN/CI-AKI by the guidelines, withholding prophylaxis is non-inferior to giving standard~     intravenous prophylactic hydration in the prevention of CIN/CI-AKI. Furthermore, the standard~     prophylactic hydration confers some risk (5.5% complications of intravenous hydration were~     recorded in the AMACING study).~      As a result the clinical protocol in the MUMC+ has been adapted, and patients with an eGFR~     >29mL/min/1.73m2 no longer receive intravenous prophylactic hydration before or after~     procedures with intravascular iodinated contrast material administration.~      CINART is a one year prospective observational study with the aim to evaluate the~     consequences of the protocol change for renal function, incidence of CIN/CI-AKI, and dialysis~     and mortality.~   "
25908|NCT03227822|"~     Since the length of lesion seems to be negatively associated with stent patency due to~     restenosis, it is thought that the efficacy of treatment in patients with multiple (> 1)~     short (focal; > 1 and < 5 cm) SFA lesions can be improved by spot stenting as compared to the~     use of one long stent. This study proposes to evaluate the endovascular treatment for~     patients with SFA lesions by comparing two strategies for patients with extensive occlusive~     SFA disease; 1) short spot (SS) stenting or 2) long lesion (LL) stenting.~   "
25909|NCT03227809|"~     Alcohol abuse is the leading cause of death and serious injury among college students, and~     students also experience significant harms from other types of substance misuse and risk~     behaviors. The proposed project is a randomized controlled trials that will test the~     protective effects of Letting Go and Staying Connected, a handbook for parents of students~     who are transitioning for the first time from home to college, the time when students are at~     greatest risk. The handbook encourages parent skill development and good management of their~     student's new independence, providing a clear framework to guide them in parenting at this~     stage. Targeted outcomes include reduction of substance use and risk behaviors. The primary~     hypothesis is that students who are in one of the two handbook conditions with their parents~     will report lower substance use and risk behaviors in the two years after college entry.~   "
25910|NCT03227796|"~     This is a first-in-human, phase 1, single centre, placebo-controlled, double-blind, single~     ascending dose study of LEVI-04 in heathy volunteers and osteoarthritis patients (with pain~     attributed to osteoarthritis of the knee)~   "
25911|NCT03227783|"~     Depression is common in Parkinson's disease (PD), but the effective treatment is not~     established yet. tDCS is a non-invasive brain stimulation to modulate brain function. The~     tDCS on the depression in general population were already conducted, but not in PD. This~     study is to know whether transcranial direct current stimulation (tDCS) is effective for the~     treatment of depression in PD. Participant will be asked to visit three consecutive days for~     the non-invasive stimulation.~   "
25912|NCT03227770|"~     This multi-center, open-label, randomized controlled trial aims to investigate the efficacy~     of hemoperfusion (HP) combined with hemodialysis (HD) by evaluating all-cause mortality and~     cardiovascular mortality in maintenance hemodialysis patients.~   "
25913|NCT03227757|"~     The primary purpose of this study is to evaluate safety and effectiveness of the Tricuspid~     Valve Repair System (TVRS) for treating symptomatic moderate or greater tricuspid~     regurgitation (TR) in patients currently on medical management and who are deemed appropriate~     for percutaneous transcatheter intervention.~   "
25914|NCT03227744|"~     This study is a clinical trial to determine whether a 12-week group therapy intervention for~     patients undergoing Active Surveillance for Prostate Cancer can relieve disease-related~     anxiety and improve quality of life and delay elective treatment of prostate cancer. The goal~     of the study is to further our understanding of anxiety in men who have been diagnosed with~     prostate cancer and are undergoing Active Surveillance. Men who have elected Active~     Surveillance for their management of prostate cancer are eligible to participate in this~     study. After signing informed consent, all participants will complete two brief~     questionnaires (The Memorial Anxiety Scale for Prostate Cancer [MAX-PC] and the General~     Anxiety and Depression Scale 7 [GAD-7] to measure their anxiety levels. If the participant~     scores above a certain number, they will be asked to participate in the study. Patients will~     be randomly assigned to either a control group, who will receive no treatment, but continue~     to follow up with their urologist to manage their prostate cancer as usual, or the treatment~     group. The treatment group will receive 12 one-hour group therapy sessions that will take~     place once a week for 12 weeks with a licensed psychologist free of charge. They will be~     instructed to follow up with their urologist as previously determined for their prostate~     cancer management. Patients in both groups will be monitored for anxiety completing three~     questionnaires, the MAX-PC and GAD-7 which they previously completed, and the Functional~     Assessment of Cancer Therapy - Prostate (FACT-P) during the 4th and 12th weeks of therapy. If~     patients require further therapy beyond the group treatment sessions, the investigators may~     refer them to a psychologist or psychiatrist for further treatment.~   "
25931|NCT03227523|"~     Introduction. Nonspecific low back pain (NSLBP) is a very prevalent medical condition,~     especially in subjects with chronic obstructive pulmonary disease (COPD).~      The diaphragm is a respiratory muscle, but it takes part in trunk stabilization on lumbar~     spine. NSLBP is related to lack of spinal control. The COPD symptoms include lack of~     efficiency in diaphragm, which could be connected to NSLBP.~      Hypothesis and objectives. COPD can contribute to NSLBP. It is associated with diaphragm~     weakness, severity of respiratory function, lower level of physical activity and quality of~     life in COPD.~      Methods. A descriptive observational cross-sectional study was conducted with two groups: the~     first one with subjects with COPD and the second one with subjects without it. Data were~     collected on: pulmonary function; respiratory muscles strength; trunk postural control;~     quality of life with COPD; physical activity level; lumbar pain presence, intensity and~     disability. Data were collected in a single session.~   "
25915|NCT03227731|"~     An Open Label randomized control study. To explore the safety of Truvada when used as PrEP~     during pregnancy and lactation. Pregnant women considered at risk for HIV infection and~     willing to participate in this randomized control study will be randomized to commencing PrEP~     in pregnancy and continued use throughout breastfeeding or deferred PrEP until breastfeeding~     cessation. All women will receive the standard of care for prevention of HIV and other~     sexually transmitted infections.~      Arm A: (Intervention): Standard HIV Prevention strategy PLUS a once daily dose of Truvada~     (FTC 200mg/TDF 300mg tablet) initiated in pregnancy, continuing until cessation of~     breastfeeding or 18 months postdelivery whichever is earliest and thereafter the option to~     continue PrEP post breastfeeding cessation.~      Arm B: (Control): Standard HIV Prevention strategy throughout pregnancy until cessation of~     breastfeeding PLUS the offer to initiate PrEP post breastfeeding cessation.~      Standard HIV prevention strategy includes risk reduction counselling, STI screening and~     treatment, condom promotion and inviting the sexual partner to receive HCT and referral for~     ART if he tests positive.~      Main Outcome Measure: Renal function, pregnancy outcomes, bone health and infant growth.~      Other Outcome Measure: Incident HIV infections, adherence to PrEP, drug resistance and~     mother-to-child transmission of HIV.~   "
25916|NCT03227718|"~     The researchers hypothesize that there is a correlation between Vestibulo-ocular reflex (VOR)~     performance and innate athletic skill level. A similar study was conducted in female, young~     adult gymnasts where a correlation was shown between VOR performance and gymnastic skill~     level. However, the results from this study did not suggest that VOR differences develop as a~     result of practice; rather that the differences in VOR may simply allow some individuals to~     become better performers. In this study the researchers would like to extend the population~     to adults both with and without a background in gymnastics to determine the natural~     relationship between VOR and innate athletic potential.~   "
25917|NCT03227705|"~     Prematurity is the leading cause of neonatal morbidity causing more than 1 million deaths~     worldwide per year. In 2012, a randomized controlled trial (RCT) testing pessary (silicone~     ring placed around the cervix) versus no pessary in patients with a short cervix showed a~     4-fold reduction in the rate of spontaneous prematurity <34 weeks of gestation and a~     reduction in perinatal morbidity and mortality. This result was not found in a subsequent RCT~     and another study on the subject had to be stopped in the face of slow recruitment.~     Currently, the obstetric scientific community believes that other RCTs are needed before~     using the pessary in the clinic as a therapeutic option to prevent prematurity in the~     presence of a short cervix. However, before starting a large RCT, it is important to test the~     feasibility of recruitment.~   "
25918|NCT03227692|"~     The purpose of this study is to compare the accuracy of knee component alignment between~     patients operated with iASSIST Knee (Investigational group) versus patients operated without~     iASSIST Knee (Control group) using the same implant system.~   "
25919|NCT03227679|"~     Nicotine mediates smoking's addictive effects in the brain. The ratio of 3-hydroxycotinine to~     cotinine, known as the nicotine metabolite ratio, or NMR, is a genetically- informed~     biomarker reflecting hepatic CYP2A6 activity and the rate of nicotine metabolism. In light of~     a recent randomized controlled trial (RCT) in humans in Lancet Respiratory Medicine, which~     found that the NMR can be used to individualize treatment for smokers, our pilot study aims~     to determine the feasibility of using NMR to guide selection of pharmacotherapy in clinical~     populations of daily smokers.~   "
25920|NCT03227666|"~     Today most fracture prevention measures targets the bone and osteoporosis. However, only~     about 20% of individuals with fractures have osteoporosis and at least 90% of all fractures~     are caused by a fall. Therefore, the present project builds on previous findings from our~     group identifying postural sway as an important risk factor for falls and aims to intervene~     against this risk factor in a randomized controlled trial targeting subjects at the highest~     risk for falls.~   "
25921|NCT03227653|"~     Efavirenz is among the preferred antiretroviral drugs for HIV-infected children. Increasing~     evidence shows that central nervous system side-effects in adults are more common than~     previously thought. Due to lack of validated tools and small sample sizes, reliable data in~     children are lacking. As HIV-infected children nowadays have a prospect of reaching~     adulthood, there is an urgent need to identify potential long-term central nervous system~     side-effects, interfering with neurodevelopment and psychosocial maturation.~      In this cross-sectional observational study the investigators will examine neuropsychiatric~     and neurocognitive functioning in 126 children (aged 6-11 years) on long-term combination~     antiretroviral therapy (cART) with or without efavirenz.~   "
25922|NCT03227640|"~     This is a prospective, multicentric (two centers: 1:San Raffaele Scientific institute, Milan,~     Italy; 2:Jagiellonian University, Collegium Medicum, Cracow, Poland), randomized (1:1)~     clinical trial that includes patients undergoing surgery for primary unilateral or bilateral~     symptomatic endometriomas.~      The aim of the study is to determine whether and to what extent the two surgical procedures~     for endometrioma, cystectomy and laser vaporization, affect ovarian reserve. Recently,~     cystectomy has been questioned as an ideal surgical approach because it may involve excessive~     removal of ovarian tissue and the loss of follicles; laser vaporization has been proposed as~     a promising method to preserve ovarian function.~   "
25923|NCT03227627|"~     Tracheostomy tubes are known to have a negative impact on swallowing. Dysphagia treatment~     includes using laryngoneuromuscular electrical muscular stimulation (LNMES). Evidence exist~     on the efficacy of LNMES in the treatment of dysphagia in adults, and scarce in pediatrics.~     There is no literature available for the efficacy of LNMES in the treatment of dysphagia on~     patients with tracheostomy tubes. The purpose of this study to determine the outcomes on~     dysphagia on children with tracheostomy tubes when treated using LNMES. Furthermore, the~     investigators aim to determine the relationship between parental stress and a child's~     modified diet.~   "
25924|NCT03227614|"~     This study aims to explore patient, support person, and health care providers' experience and~     satisfaction with social support in the abortion procedure room. Although some providers do~     allow a support person in the abortion procedure room, no study has formally examined the~     effects of this practice.~      If this study demonstrates higher patient satisfaction and lower perceptions of pain and~     anxiety levels in patients who have social support in the in-clinic abortion procedure room,~     this could change standard procedures in the in-clinic abortion procedure room, allowing for~     more positive patient experiences.~   "
25925|NCT03227601|"~     Congenital Zika virus syndrome (SCZv) has been gaining attention in studies due to changes in~     the central nervous system and in the motor development of children. These changes resulted~     in an unexpected picture and without future predictability, with the appearance of several~     functional impairments and also on orthostatic posture. In this context, the protocol of~     orthostatism proposed here is a 10-week program of the use of a postural adjuster, the~     standing frame, made of its own with alternative material to the commercial models~     (cardboard). The use of low cost materials allows these devices to be made in the desired~     size without cost high, individually adapted, easy to be transported as it is light and can~     still be colored. It is an equipment that offers the opportunity to experience the~     orthostatic posture and mainly benefits children with little economic resources that enable~     the acquisition of traditional devices made of iron or wood and even imported equipment. The~     postural adjuster allows physical and sensorial opportunity, being an auxiliary resource in~     standing positioning, feasible for home use, besides being useful for performing functional~     activities. Thus, the objective will be to analyze the repercussions of the use of the~     standing frame on body alignment, muscle tone, gross motor function and gastrointestinal~     functions of children with SCZv. An uncontrolled intervention study will be conducted with~     children between 12 and 24 months of age, who will undergo an evaluation before use and after~     the use of the adjunct along with the proposed orthostatism protocol. The postural alignment~     will be evaluated through photogrammetry and the evaluation of muscle tone will be performed~     through the modified Tardieu scale. The Gross Motor Function Measure (GMFM) scale will be~     used to assess the gross motor function of the children involved in the study. Questionnaires~     will be applied for the collection of maternal socio-demographic data, the child's data, the~     type and time of therapy that the child already participates, and the gastrointestinal~     functions. Evaluations will occur in four moments: initial / before use, on the first day of~     placement in the adjuster, after the first month after use and after the second month of use.~     For statistical analysis, the Shapiro Wilk Test will be applied to evaluate the normality of~     the data, and the Friedman or ANOVA tests for repeated samples, to analyze intra-group time~     factor for the dependent variables of each individual.~   "
25926|NCT03227588|"~     The use of fractional flow reserve (FFR) has improved outcomes in percutaneous coronary~     interventions (PCI) in patients with symptomatic stable coronary artery disease (CAD) with~     intermediate angiographic stenoses. It is a clinical tool used routinely in cardiac~     catheterization laboratories throughout the world including the Little Rock VA Hospital. The~     technique utilizes a pressure transducer constructed as part of an 0.014 guidewire. An FFR~     of >0.80 has been linked with myocardial ischemia found with nuclear stress and dobutamine~     echo stress testing. The FAME trial clearly demonstrated its value in improving long-term~     outcomes as compared to use of angiography alone. As such, the use of FFR is incorporated~     into both AHA ACC and European PCI guideline recommendations as part of routine care for~     intermediate lesions. A work horse guide wire is so defined because it can be used in most~     PCI cases. It combines a low tip load (to avoid intimal dissection, with excellent (ideally,~     one to one) torque transmission and trackability through tortuous lesions. Recently the FDA~     has approved an FFR guide wire, OptoWire, (Opsens, Quebec City, Quebec, CAN) which uses light~     transmission to measure pressure rather than electrical transduction wires. The primary~     purpose of the present study is to determine how effective this wire is as a work horse wire~     in patients in whom FFR is required. The OptoWire may also have the advantage of less drift~     occurring during the procedure. Drift refers to the change in pressure due to issues related~     to the wire and measuring system, rather than a true change in pressure. All current FFR wire~     systems demonstrate some degree of drift requiring measuring pressure of the wire in the~     aorta after the procedure is completed to determine if, and to what extent, drift has~     occurred. Thus, a secondary aim of this study will determine the degree of drift.~   "
25927|NCT03227575|"~     Physical activity is shown to positively reduce the risk of developing both cardiovascular~     disease and type 2 diabetes. Current guidelines recommend 30-60 minutes of moderate intensity~     cardiorespiratory exercise five days per week. However, studies report that <40% of young~     adults 18-24 years achieve the recommended weekly physical activity guidelines, and close to~     40% of young adults are overweight or obese. Traditional aerobic exercise and high intensity~     exercise have been shown to improve glycemic control in young and middle-aged sedentary~     adults, however, long term implementation of such exercise regimens are difficult. Recent~     evidence suggests that short bouts (15 minutes) of moderate intensity walking following a~     meal, significantly improves glycemic control in older adults with impaired glucose control.~     Due to the low burden of walking on participants, moderate intensity post-meal walking might~     be a better alternative exercise intervention to improve overall health in a sedentary~     population. Therefore, the purpose of this pilot proposal is to determine if 15 minutes of~     post-meal walking is an effective intervention to improve glycemic control in sedentary young~     adults at risk for developing MetS. Additionally, the study will investigate whether~     ambulatory blood pressure profiles in obese young adults are disrupted.~   "
25928|NCT03227562|"~     Risperidone at low dosage is often used as treatment of acute anxiety symptom. However,~     patients may be either responder or not. Here we hypothesized that the early response to a~     low dose of risperidone is predictive to risperidone efficiency.~      Subjects with acute anxiety symptoms (Hospital anxiety depression scale) and risperidone~     prescription would be proposed to be enrolled in the study. A check-up is made at D0, then~     the subjects begin the treatment (0.5mg risperidone). The same check-up is carried out on the~     following day (D1). The subjects fulfil a last check-up 12 week after the beginning of~     treatment (W12). During the D1-W12, the psychiatrist may changes the treatment.~   "
25929|NCT03227549|"~     Hip replacement surgery is an effective option for treating pain and functional impairment in~     chronic hip conditions. Various surgical approaches have been developed to expose the hip~     joint for the procedure, each with advantages and disadvantages. The posterior approach (PA)~     to total hip replacement is a commonly used exposure method. This approach involves a large~     incision and requires multiple cuts through muscle and other soft tissues to expose the hip~     joint. Despite excellent outcomes, the PA is known to have an increased rate of dislocation~     compared to other exposures. The direct superior (DS) approach has been developed to improve~     the PA by decreasing the amount of soft tissue injury at the time of surgery and improving~     postoperative stability. The DS approach involves a much shorter incision and reduces the~     need to damage as much soft tissues surrounding the hip joint during exposure. Specialized~     equipment developed for this technique allows the surgeon to place the hip replacement~     components. The proposed research study is designed to address a deficit in knowledge~     regarding outcomes on patients who have had a DS approach for total hip arthroplasty. This~     study will provide much needed insight into the advantages and disadvantages of the DS~     approach as compared to PA for total hip arthroplasty.~   "
25930|NCT03227536|"~     This is an historic cohort study based on the birth and delivery register of the HFME~     maternity ward. This study aim at understanding the evolution of asphyxia at birth, at all~     gestational ages, identifying causes and describing neonatal outcomes since 2000, when a~     second line strategy for foetal surveillance (fetal ECG) and systematic umbilical acid-gas~     cord blood were introduced in our maternity ward.~      The investigator's hypothesis was that the neonatal asphyxia decrease could be due to 3 main~     factors including second line strategy introduction, systematic umbilical cord acid-base~     implementation and improvement in antenatal risk factor screening for asphyxia. The~     investigator's second hypothesis was that neonatal prognosis in neonates with acidosis was~     improved with systematic early after birth EEG evaluation, allowing early treatment and~     surveillance.~   "
25932|NCT03227510|"~     Hepatocellular carcinoma (HCC) is the most common primary liver cancer and is the third~     leading cause of cancer that related death in the worldwide. Although, current most of~     doctors and laboratorians of HCC diagnoses bases are medical imaging such ultrasound, MRI,~     CT-scan and laboratory analyses tests for serum tumor markers such as alpha-fetoprotein (AFP)~     which characterized by very low of sensitivity in the detection of HCC. Last two decades,~     scientists was focused researches of small molecules called MicroRNAs which are produced by~     human cells and can be released in the blood.~      MicroRNAs are class of (20 - 25 nucleotide in length) non-coding RNAs, and its emerging~     non-invasive diagnostic biomarker for cancer diagnosing, screening, monitoring treatment and~     to predict prognosis. A number of studies exposed an abnormal expression of human serum~     MicroRNAs in many tumors such as liver, pancreatic and colorectal carcinoma. Recently,~     MicroRNAs have a role in the development of HCC, but still it is unknown if these small~     molecules will be used as biomarker for diagnosis and survival of HCC.~      The aim of this study is to establish MicroRNAs as biomarkers for diagnostic tool of HCC~     patients and to compare to circulating levels of MicroRNAs in chronic liver diseases patients~     and health volunteers and those HCC patients and To determine the clinical utility of~     MicroRNAs as a diagnostic maker of hepatocellular carcinoma comparing with alpha fetoprotein~     the current marker of (HCC).~   "
25933|NCT03227497|"~     This cross-over study investigates health effects of dietary intake of whole walnuts towards~     cardiovascular risk factors in adults under low cardiovascular risk.~      Investigators hypothesize that daily intake of whole nuts as a replacement meal, would~     improve cardiovascular risk factors, including traditional risk factors and molecular~     biomarkers.~      The participants are randomly assigned to receive either study treatment, or no treatment,~     and are crossed after five weeks.~      The study subjects are instructed to continue with their habitual diet and physical activity.~   "
25934|NCT03227484|"~     Recently, various sodium glucose cotransporter 2 (SGLT2) inhibitors have been approved for~     the treatment of type 2 diabetes mellitus. Empagliflozin is a preparation of this class of~     substances. SGLT2 inhibitors also lead to a reduction in body weight in addition to their~     blood glucose lowering effect. The basis for this is probably the calorie loss by the~     increased glucose excretion over the urine. However, this weight-reducing effect is lost~     after a few weeks of treatment and the body weight subsequently stabilizes at a lower level~     than before. However, patients continue to lose energy via the urine. Hence, the weight~     stabilization could be due to an increased energy intake as a possible consequence of a~     changed brain setpoint for the body weight. As the main weight loss is achieved during the~     first 6-8 weeks of treatment, the investigators assume that the underlying central nervous~     mechanisms will be present after this time.~      Furthermore, clinical-experimental observations show that treatment with empagliflozin~     promotes endogenous glucose production in the liver. This presumably compensatory mechanism~     also occurs after only a few weeks of treatment. The common mechanism, which could be based~     both on energy intake and on the endogenous glucose production effect, is still unclear. The~     investigators suspect that regulatory circuits in the brain contribute to these observed~     effects.~      In fact, several studies in animals as well as initial clinical studies in humans show that~     the brain is involved in eating behavior and peripheral metabolism. In particular, effects of~     the hormone insulin modulate the dietary intake via the brain, thereby affecting human body~     weight.~      Many of the experiments on the insulin sensitivity of the human brain used a specific~     approach to the selective delivery of insulin into the brain: the application of insulin as a~     nasal spray. Although this application route has no therapeutic value, this technique allows~     the administration of insulin to the central nervous system with little effect on the~     circulating insulin levels. By combining nasal insulin administration with functional MRI,~     regional insulin sensitivity of the brain can be quantified. The investigators recently found~     that the insulin action of the brain (stimulated by nasal insulin) regulates both endogenous~     glucose production and peripheral glucose uptake during hyperinsulinemic euglycemic glucose~     clamps. The signals from the brain seem to reach the periphery via the autonomic nervous~     system in order to modulate metabolic processes. A central brain area in this regard is the~     hypothalamus. This brain region receives afferents over various systems such as the autonomic~     nervous system and various endocrine systems (including insulin). The investigators recently~     characterized the hypothalamus as an insulin-sensitive brain area in humans. The hypothalamus~     is the key area for homeostatic control throughout the body.~      Since the dietary intake and the endogenous glucose production are modulated by a~     hypothalamic insulin effect in humans, we suspect that the observed effects of SGLT2~     inhibitors on both processes could be due to altered insulin activity in the brain. Since the~     SGLT2 inhibition by empagliflozin modulates the autonomic nervous system in the kidneys,~     signals from the kidney may be transmitted to the brain via the autonomic nervous system,~     thereby changing specific setpoints, including e.g. insulin sensitivity of the brain.~      In order to test this hypothesis, a precise phenotyping of prediabetic volunteers with regard~     to regional brain insulin sensitivity as well as the brain effect on metabolism before and~     after 8 weeks of treatment with empagliflozin compared to placebo is planned.~   "
25935|NCT03227471|"~     This is a first-in-human and proof-of-concept study of VX-445. The study includes 6 parts.~     Parts A, B, and C will be conducted in healthy subjects. Parts D, E, and F will be conducted~     in subjects with Cystic Fibrosis (CF) who are homozygous for the F508del mutation of the CF~     transmembrane conductance regulator (CFTR) gene (F/F genotype), or who are heterozygous for~     the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ,~     IVA, or TEZ/IVA (F/MF genotypes).~   "
25936|NCT03227458|"~     To determine whether the musculoskeletal adaptations to bone-loading exercise can be~     significantly augmented in older women (aged 60-85) with low bone mass (osteopenia; T-scores~     <-1.0 and >-2.5) by restoring serum DHEAS to young adult levels by oral DHEA replacement.~   "
25937|NCT03227445|"~     This randomized, cross over study aims to find out the benefits of delivering triple therapy~     using a single ELLIPTA® DPI (fixed-dose combination triple therapy) versus delivering triple~     therapy using two different types of inhalers (open triple therapy) including DISKUS® with~     HandiHaler® to subjects with COPD. Correct inhaler use, critical errors and performance~     attributes will also be assessed. Approximately 240 subjects with COPD will be randomized in~     the study. The study will be conducted in 3 visits and will be completed in approximately 56~     days. At Visit 1 (Day 1) and Visit 2 (Day 28) subjects will be randomized to receive a~     placebo ELLIPTA inhaler once daily (QD) or a placebo DISKUS twice daily (BID) with placebo~     HandiHaler QD inhaler in 1:1 ratio in a cross-over manner for the study period (28 days for~     each period). At Visit 3 (Day 56), subjects will be asked to complete preference~     questionnaire 1 or 2. There will be no active treatment and subjects will continue to take~     their own prescribed COPD maintenance and rescue medication during the entire study period.~     ELLIPTA and DISKUS are the registered trademarks of GlaxoSmithKline group of companies.~     HandiHaler is the registered trademark of Boehringer Ingelheim group of companies.~   "
25938|NCT03227432|"~     This research study is studying a combination of targeted therapies as a possible treatment~     for multiple myeloma (MM).~      The drugs involved in this study are:~        -  Elotuzumab~        -  Nivolumab~        -  Pomalidomide~        -  Dexamethasone~   "
25939|NCT03227419|"~     Rheumatoid arthritis (RA) is the most common inflammatory rheumatoid disease in France,~     affecting 0.3% of the general population. Without effective treatment, the persistent~     inflammation causes invalidating pain and joint destruction, leading to major functional~     disability.~      Biological agents have been proposed for patients with RA who have the most severe form of~     the disease and that are inadequate responder patients to conventional synthetic~     Disease-modifying antirheumatic drugs (csDMARDs). TNF inhibitors (TNFi) are historically~     proposed as the first biological DAMRD for inadequate responder patients to csDMARDs. A~     diverse therapeutic arsenal has become available in recent years with the development of~     non-anti-TNFα drugs whose mechanisms of action are different from the classical TNFi. This~     new biotherapy class includes tocilizumab and abatacept, two drugs recently available for~     subcutaneous administration that enables ambulatory care for patients who would otherwise~     require repeated in-hospital care.~      The role of these new treatments in the therapeutic strategy has been emphasized by studies~     that demonstrated their efficacy as first-line treatments. However, in clinical practice,~     TNFi remain the most common first-line treatment for the majority of patients, non-anti-TNFα~     biological agents being reserved for inadequate responder patients.~      In second line, several studies have investigated therapeutic strategies for inadequate~     responder patients to TNFi. Current data suggest that it could be wise to change the~     therapeutic target after failure of a first-line treatment with TNFi.~      Data about the comparative efficacy of different biologics proposed after failure of a~     first-line treatment with TNFi are in progress. Meta-analyses from registries and academic~     trials conducted in France and The Netherlands suggest that non-anti-TNFα agents would have~     equivalent or superior efficacy compared with a second TNFi. This finding suggests clinicians~     to switch for an alternate therapeutic target after failure of a first-line TNFi.~      Data comparing different non-anti-TNFα biologics in inadequate responder patients to TNFi are~     scare. Industrial trials have demonstrated sustained biological efficacy of non-anti-TNFα~     biologics after failure of a TNFi. However, there is very little solid data on the direct~     comparison between them.~   "
25940|NCT03227406|"~     To further understanding of the relationship between sleep and memory the investigators will~     address and attempt to answer three questions, (1) how memories evolve across wake and sleep,~     (2) how different aspects of this memory evolution are reflected both behaviorally and in the~     EEG signal, and (3) what stages and features of sleep affect memory evolution. Together,~     these studies will provide a greater breadth and depth of knowledge concerning sleep's role~     in memory consolidation. Such knowledge would be of practical importance for educational~     practices, whether in schools, on the job, or in the military, and would also provide~     valuable information to the fields of sleep medicine and psychiatry, where interactions~     between sleep disorders and cognitive functioning are of great importance.~   "
25941|NCT03227393|"~     The purpose of this study is to evaluate if yoga practice will reduce cardiac sympathetic~     activity and subsequently cardiac arrhythmias.~   "
25943|NCT03227367|"~     The present study is an effort to investigate the hypothesis that Platelet Rich~     Fibrin/Biphasic Calcium Phosphate may play a role in inhibiting osteoclasts differentiation~     and in bone loss.~   "
25944|NCT03227354|"~     Primary objective of this study is to assess the accuracy and precision of intracranial~     pressure (ICP) measurement in patients after traumatic brain injury and subarachnoid~     hemorrhage when using simultaneous, non-invasive measurement compared to standard, invasive,~     measurement.~      Secondary objective: is to assess the correlation of intracranial pressure (ICP) measurement~     in patients after traumatic brain injury and subarachnoid hemorrhage between simultaneous,~     non-invasive measurement and standard, invasive,measurement~   "
25945|NCT03227341|"~     The investigators compared the effectiveness of pulmonary rehabilitation program on asthma~     control in patients with uncontrolled and partially controlled asthma.~   "
25946|NCT03227328|"~     Prospective, open label, multicenter, randomized phase III study, comparing two strategies as~     first chemotherapy-based treatment for locally advanced or metastatic luminal breast cancer.~        -  Arm A: concomitant chemotherapy plus an aromatase inhibitor (AI); the AI must continue~          until disease progression or toxicity or patient refusal; chemotherapy may be stopped~          after achievement of maximum response (generally after at least about 3-6 months of~          treatment) or in case of toxicity or patient refusal.~        -  Arm B: chemotherapy followed by an AI at the time of progression to chemotherapy (if an~          endocrine therapy is deemed indicated by the treating physician) or as maintenance~          therapy after achieving maximum response to chemotherapy (generally after at least about~          3-6 months of treatment) or after stopping chemotherapy for toxicity or patient refusal.~   "
25947|NCT03227315|"~     Preoperative anxiety level of patients affects postoperative analgesic consumption. However,~     there were no studies that showed a relationship between the level of stress tolerance and~     analgesic consumption in the literature. In this study, investigators wanted to investigate~     the effect of stress tolerance on analgesic consumption of patient.~   "
25948|NCT03227302|"~     In China, the standardized training system for residents was built last year, and the~     associations of the grades of doctors and accoucheurs and neonatal outcomes remains unclear.~   "
25949|NCT03227289|"~     Acute respiratory distress syndrome in neonates has been defined in 2015. Earlier~     identification and successful intervention into the potential pregnancy associated risk~     factors for the conversion from NRDS to ARDS is one of the most important components of ARDS~     prevention.~   "
25950|NCT03227276|"~     To evaluate the efficacy of Litramine in reducing body weight in the context of an~     energy-restricted diet in overweight and moderately obese subjects~   "
25951|NCT03227263|"~     The recognized manifestations of HHT are all due to abnormalities of vascular structure.~     Epistaxis and digestive arteriovenous malformations may be responsible for severe hemorrhages~     in 5% of HHT patients, requiring repeated blood transfusions and are associated with high~     morbidity. There is currently no standard and efficient management of this severe symptom. It~     is also well known that HHT-associated hemorrhages have the greatest negative impact on~     quality of life among HHT patients, and is responsible for anemia, blood transfusions,~     hospitalizations, depressive syndrome and a high psycho-social impact.~      Since 2006, it has been suggested by animal models and then by clinical reports that~     anti-VEGF therapy may be useful to treat HHT. 4 case reports have been published on efficacy~     of intravenous bevacizumab, a humanized monoclonal antibody in HHT on severe hemorrhages.~      Intravenous bevacizumab has been used in a previous clinical trial to measure efficacy and~     tolerance of this drug in HHT patients with severe liver involvement. Furthermore, a~     reduction was observed in the duration of the nosebleeds after treatment and was encouraging~     to treat bleeding. We completed this study by a pharmacokinetic-pharmacodynamic (PK-PD) model~     in order to assess the individual concentration-effect relationship of bevacizumab.~      However, no randomized prospective study has been performed and published to evaluate the~     efficacy in this indication. A total of 24 patients will be randomized versus placebo in a~     multicenter phase III trial. The Avastin or placebo will be infused at 5mg/kg every 14 days~     with a total of 6 cures with a 3 months following period.~   "
25952|NCT03227250|"~     This study aims to evaluate the effect of deep brain stimulation in the the globus pallidus~     (Gpi) on freezing of gait in patients with Parkinson's disease.~   "
25953|NCT03227237|"~     Assess the impact of Strained Interpersonal Relationship (IPR) with parents on Juvenile~     Delinquency among Children residing in Selected Delinquent Home Ambala, Haryana~   "
25954|NCT03227224|"~     The purpose of this study is to assess the dose-response relationship of 2 doses of~     JNJ-42847922 before interim analysis, and potentially 3 doses based on interim analysis~     results, compared to placebo as adjunctive therapy to an antidepressant drug in improving~     depressive symptoms in participants with Major Depressive Disorder (MDD) who have had an~     inadequate response to current antidepressant therapy with a selective serotonin reuptake~     inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI); and to assess the~     safety and tolerability of JNJ-42847922 compared to placebo as adjunctive therapy to an~     antidepressant in participants with MDD.~   "
25955|NCT03227211|"~     To develop predictive models for short-term readmission (60 days) and medium term (one year)~     for patients with an exacerbation of COPD (eCOPD) which are admitted to any of the~     participant hospitals. To identify factors contributing to readmission from the time of~     discharge from the index admission to the studied readmission time. Methodology. Design:~     Prospective cohort study with a nested case control study, with follow up to one year.~     Patients: 1500 patients admitted over a year and a half in any of the 9 participant hospitals~     by an eCOPD. Methods: During admission, background information on patient situation prior to~     admission, data of the ED during admission, and discharge planning, will be collected from~     medical history. The investigators will also survey patients (generic and specific~     health-related quality life -HRQoL- dependence, social support, presence of fragility). All~     patients will be followed to determining whether any readmission until 60 and up to one year~     of discharge from the index admission occurs. Patients readmitted at the first 60 days after~     discharge will be surveyed on a number of possible causes of readmission (continuity of care,~     medication, complications, individual and social factors). A one to one control group will be~     established to compare different factors studied in the case group (readmission). Statistical~     analysis: predictive models will be developed from the derivation sample, and validated in a~     validation sample. Also, the factors evaluated in the case-control study will be compared~     using appropriate test for paired samples.~   "
28177|NCT03198169|"~     This is a 2-part pilot study to determine the clinical effectiveness of two new antimicrobial~     products on the complete healing of chronic wounds.~   "
25956|NCT03227198|"~     This is a prospective, randomised double blind, controlled, parallel-group phase I and II~     study. Its aim is to assess the Evaluation of the intramyocardial injection of autologous~     bone marrow derived mononuclear stem cells is safe and effective in hear failure patients~     with reduced left ventricular ejection fraction(<=30%) when compared to a control group of~     patients undergoing best medical care.~   "
25957|NCT03227185|"~     Previous studies showed that anodal tDCS applied over the dorsolateral prefrontal cortex~     (DLPFC) improved episodic memory performance, indicating a possible use as an intervention~     for patients suffering from memory impairments. At the same time, only scant evidence~     (provided by functional magnetic resonance imaging (fMRI) and magnetic resonance spectroscopy~     (MRS)) exists regarding the underlying mechanisms, thus hindering a more targeted~     application.~      The present study aims at establishing a connection between the stimulation-induced change in~     episodic memory performance on the behavioural level and neurophysiological parameters. TDCS~     effects and the underlying mechanisms will be compared between different study conditions,~     receiving either real anodal tDCS or sham stimulation over the left dorsolateral prefrontal~     cortex during an episodic memory task.~   "
25958|NCT03227172|"~     The radiolucent periapical jaw lesions of 34 patients, which were surgically enucleated, were~     investigated by two radiologists using MRI, based on the same six criteria, to categorize the~     lesions as granulomas or radicular cysts. After apicoectomies, two oral pathologists (blinded~     to the radiologist's diagnoses) analyzed all specimens by referring to seven specific~     parameters and diagnosed the specimens as granulomas or radicular cysts. The inter-rater~     agreements between the radiologists and pathologists in terms of MRI and histological~     diagnoses, respectively, along with the discriminant power of the adopted criteria and the~     accuracy of the MRI assessments compared with the histopathologic results, were calculated.~      A strong inter-rater reliability was observed between the two radiologists (k-statistic =~     0.86, p = 0.0001) and the two pathologists (k-statistic = 0.88, p = 0.0001). Reliability was~     higher for the radiological (Guttmann's lambda lower bound > 0.6) than histopathological~     criteria. The accuracy (true positives plus true negatives) of the radiologists was higher~     than that of the pathologists based on receiver operator characteristic analysis (area under~     the curve = 0.87 and 0.91, respectively). MRI reliability and accuracy were high and~     comparable to histopathological reliability, highlighting the usefulness of this non-invasive~     exam as a pre-treatment diagnostic method for periapical endodontic lesions.~   "
25959|NCT03227159|"~     This is a national multi-center, prospective surveillance study in patients with suspected~     acute coronary syndrome. Eligible patients must present to one of the participating Emergency~     Departments within 24 hours from the time of symptom onset. Approximately 2000 patients >18~     and <85 years of age are planned to be enrolled.~      Upon enrollment in the Emergency Department, a venous blood sample will be obtained from each~     patient for analysis. The patient's diagnostic work-up, treatment and disposition will~     continue per the standards of the treating institution. Results will be recorded for ECGs,~     any cardiac biomarkers measured at the site and any follow-up cardiac objective tests~     performed for evidence of coronary artery disease and/or myocardial damage (exercise~     treadmill, coronary angiography, cardiac thallium or technetium scintigraphy, etc).~      The Principal Investigator at each site will evaluate the results of the diagnostic cardiac~     tests performed for that patient to determine whether each patient enrolled at their site has~     a final diagnosis of ACS.~      The status of each patient will also be assessed at 1 month and 6 months after enrollment for~     intercurrent Major Adverse Cardiac Events (MACE), including myocardial infarction, cardiac~     revascularization and death.~   "
25960|NCT03227146|"~     This phase IIb trial aims to evaluate the efficacy and safety of EHSG-KF (synonym denovoSkin)~     in comparison to meshed STSG in adult patients with partial deep dermal and full thickness~     burns.~   "
25961|NCT03227133|"~     The study focuses on the identification of clinical, physiological and morphological markers~     that could predict the response to antidepressant in elderly suffering from unipolar~     depressive disorder.~   "
25962|NCT03227120|"~     The primary aim of this study is to determine the effects of pre-surgery exercise known as~     Prehabilitation, on functional outcomes for patients following Total Knee Arthroplasty (TKA)~     surgery. The hypothesis is patients that receive effective pre-surgery prehabilitation will~     demonstrate improved recovery as measured by the 6-minute walk (6MW) test at one month post~     surgery.~   "
25963|NCT03227107|"~     1. enrollment criteria and clinical data collection: follow the principles of medical~          ethics, the development of inclusion and exclusion criteria, select 90 cases of ARDS~          patients, in the active treatment at the same time, according to the Berlin standard~          severity of the disease divided into mild group, moderate Group and severe group,~          according to the prognosis during hospitalization is divided into survival group and~          death group. BALF specimens were collected on the day of admission to detect the levels~          of NETs and alveolar macrophages. The acute and chronic health status scoring system Ⅱ~          (APACHEⅡ) and Murray acute lung injury score, blood routine, creatinine, urea nitrogen,~          fasting blood glucose, Item, mean arterial pressure, arterial blood gas analysis,~          oxygenation index; record the patient's mechanical ventilation time and other data;~        2. Pearson linear correlation analysis of BALF in the content of NETs, alveolar macrophage~          coke death level was a positive correlation between the Spearman rank correlation~          analysis BALF in the NETs content and alveolar macrophage coke death level, APACHE Ⅱ,~          Murray score, creatinine, Urea nitrogen, fasting blood glucose and other indicators and~          ARDS severity was positively correlated;~        3. To analyze the prognostic factors of different prognostic factors, to evaluate the~          content of NETs in BALF, the level of alveolar macrophage coke, APACHEⅡ and Murray~          scores were analyzed by receiver operator characteristic curve (ROC curve) Short - term~          survival outcome prognostic value.~   "
25974|NCT03226964|"~     This study is a prospective randomised trial where a computer will randomly allocate~      patients to one of two possible methods of delivering oxygen during the procedure of~      bronchoscopy. This trial compares high flow nasal cannula (HFNC) with nasal prongs in~      delivering oxygen to patients undergoing endo-bronchial ultrasound guided trans-~      bronchial nodal aspiration (EBUS-TBNA) a specialised form of bronchoscopy procedure.~      HFNC uses humidified higher gas flow rates than conventional low flow systems such as~      nasal prongs which are limited by the respiratory rate and effort.~   "
25964|NCT03227094|"~     Cystic fibrosis (CF)-related diabetes (CFRD) is the most common complication after pulmonary~     complications. This specific form of diabetes is associated with an increased morbidity and~     mortality. CFRD prevalence at the age of 10 is 10% and reaches 40 to 50% in adulthood, while~     another 35% of adult patients presents impaired glucose tolerance.~      In order to identify patients at risk and to implement early therapeutic measures, an annual~     CFRD screening test should therefore be undertaken for CF patients after 10 years of age. The~     2-hour oral glucose tolerance test (OGTT) with a sweet beverage is the recommended screening~     test. However, participation rates for screening tests are far from optimal. For examples, in~     2015, the investigators observed that only 47% of non-diabetic patients attended to planned~     screening despite large availability and advertisement (unpublished data). Comparable low~     levels of screening for CFRD, usually below 33%, have been reported by various teams. Several~     reasons could explain these low adherence rates. Some factors are related to patients~     perceptions and experience: OGTT is perceived as an additional medical burden requiring a~     scheduled appointment (several weeks after the last exacerbation); overnight fasting followed~     by the intake of a large glucose load within 5 minutes can lead to nausea, headache, bloating~     and fatigue; some patients fear multiple blood sampling, etc. In addition, in case of CFRD~     diagnosis, recommended capillary blood glucose monitoring, nutritional advice and treatment~     (insulin) are perceived as extremely invasive and complex, thus some patients prefer avoiding~     screening test. To date, no alternative screening method has demonstrated its effectiveness~     to screen for CFRD. The investigators of this study believe that a simplified version of the~     OGTT would be more attractive, would make it more acceptable for patients and has the~     potential to improve their adherence to screening tests, simplify CF-team works and reduce~     costs. By allowing appropriate education and introduction of treatment in a timely manner,~     improved adherence to annual screening for dysglycemia has the potential to minimize or~     prevent clinical deterioration observed in years preceding CFRD onset.~   "
25965|NCT03227081|"~     The purpose of the study is to examine whether sleep affects the development of intrusive~     memories.~   "
25966|NCT03227068|"~     After the initial hospitalization, parents of children newly diagnosed with cancer assume~     responsibility for assessing and managing their care; however, parents are often overwhelmed~     with information received throughout the hospitalization and are apprehensive about caring~     for their child at home. Parents want concise, focused information on how to care for their~     child after the hospital discharge. Two parent education discharge support strategies (PEDSS)~     were created to use at hospital discharge. PEDSS consists of a symptom management~     intervention and a support for the caregiver intervention. A cluster randomized control trial~     will assess the effectiveness and feasibility of the two different interventions.~   "
25967|NCT03227055|"~     This 3-year study will systematically evaluate the prevalence, clinical symptoms, and~     progression of CV and kidney disease and assess the impact of potential genetic,~     pharmacological, behavior, and environmental risk factors in a prospective cohort with a~     sample size of 125 aged 3-18 years children with stage G1-G4 chronic kidney disease (CKD).~     Measurements of morphological (e.g., LVMI & cIMT) and functional characteristics (e.g., FMD &~     PWV) of the cardiovascular system and 24hr ABPM profile will serve as surrogate end points~     for CV comorbidity in this study. Possible associations of these end points with multiple~     molecular (ADMA & urine exosome miRNA), perceived value and behavior (EQ-5D-Y),~     pharmacological (NHIRD and CGRD), and environmental risk factors (patient and family survey)~     will be explored.~   "
25968|NCT03227042|"~     This is a natural history study for children up to 18 years of age who have been diagnosed~     with Mucopolysaccharidosis Type IIIB (MPS IIIB, also known as Sanfilippo Syndrome Type B).~     Mucopolysaccharidosis type IIIB is a severe neurodegenerative disorder. The information~     gathered from this trial may help inform the design and interpretation of subsequent~     interventional studies. No clinical intervention or study drug is provided by BioMarin in~     this study.~   "
25969|NCT03227029|"~     The purpose of this study is to evaluate the infectivity, safety, and immunogenicity of the~     recombinant live-attenuated respiratory syncytial virus (RSV) vaccines RSV ΔNS2/Δ1313/I1314L~     or RSV 276 or placebo when delivered as nose drops to RSV-seronegative infants 6 to 24 months~     of age.~      This study is a companion study to CIR 321.~   "
25970|NCT03227016|"~     For this study sensitive or refractory SCLC patients (refractory to prior chemotherapy~     defined as having experienced no response or a relapse within 90 days after the end of~     chemotherapy) will be eligible. In total, around 130 patients will be enrolled, around 30~     evaluable patients in phase I and 100 patients in phase II.~      The study will consist of two parts:~      A preceding Phase I part will be performed to identify the Recommended Dose of veliparib to~     be administered in the Phase II part in combination with topotecan at the dose regimen of~     1.25 mg/m2 (on days 1-5 of a 3 week cycle [d1-5q21d]). Each patient will be subjected to an~     initial cycle of topotecan monotherapy (1.25 mg/m2 on day 1-5 of a 3 week cycle); this run-in~     cycle shall prove topotecan tolerance of the candidates. Only patients who do not reveal any~     DLTs receive further treatment with combination therapy. In a dose-escalating 3+3 design the~     RD of veliparib for the subsequent Phase II part of the study will be defined during a~     maximum of 5 cycles combination therapy.~      The Phase II part will follow upon completion of Phase I.~   "
25971|NCT03227003|"~     The present study used a sub-sample of the Melbourne Collaborative Cohort Study (MCCS) (Milne~     RL et al, Int J Epidemiol, 2017), who had valid data on dietary intakes (121-item food~     frequency questionnaire) and valid measures of DNA methylation using the HumanMethylation~     Infinium 450K Beadchip assay, or using LINE-1, Alu and Sat2 assays.~      The investigators studied the association between nutrients involved in one-carbon metabolism~     and DNA methylation in peripheral blood.~   "
25972|NCT03226990|"~     Forty completely edentulous patients were selected and randomly distributed into two groups~     20 patients each.Group I received complete dentures constructed from elastomeric impression~     with wax spacer,group II received complete dentures constructed from elastomeric impression~     with no wax spacer.then on time of denture insertion pressure areas were detected using~     pressure indicating paste and the denture retention was detected.The results showed less~     pressure areas in group I and more denture retention values than group II.~   "
25973|NCT03226977|"~     In the past, several studies have compared the effects between nasal intermittent positive~     pressure ventilation(NIPPV) and nasal continuous positive airway pressure(NCPAP) on the~     incidence of intubation in preterm infants, and the results were inconsistent.The purpose of~     the present study was to compare NIPPV with NCPAP on the need for endotracheal ventilation~     and subsequent complications~   "
25975|NCT03226951|"~     Is to determine if SDM laser can reduce macular thickness in non central CSME and stop the~     progression of non central CSME to central CSME in compare to glycemic control~   "
28178|NCT03198156|"~     1. To determine the effects of transcranial direct current stimulation (tDCS) on vigilance~          in subjects with central hypersomnia without cataplexy.~        2. To determine the effects of tDCS on subjective measures of sleepiness and alertness in~          subjects with central hypersomnia without cataplexy.~   "
25976|NCT03226938|"~     Understanding the impact of dietary patterns, exercise, and behavior change in the prevention~     of disease is paramount to improving the health and well-being of future generations and~     economies. A gap in the research is the lack of data on factors that predict successful~     behavior change for sustained dietary practices chosen for health or other personal reasons.~     To date, no survey exists that was designed to target persons following a wide range of~     popular dietary patterns (e.g., Paleo, low-carb, vegetarian, vegan, Mediterranean,~     gluten-free, etc.). These dietary patterns, which offer great variation in macronutrient~     composition, are unique and unexplored in other similar surveys to date, making their~     examination innovative. Adhering to Dietary Approaches for Personal Taste (ADAPT) will be the~     first large cohort of its type that is focused on adherence to popular dietary patterns,~     providing the opportunity to better understand how individuals can be supported to~     successfully maintain a specific dietary practice, and, in the long-term, how these practices~     may influence parameters of healthy aging.~   "
25977|NCT03226925|"~     Mechanical ventilation can be used to impose a completely regular pattern of breathing~     frequency and inflation volume on the patient for as long as required. This would~     considerably improve the reproducibility of the internal motion parameters, and thus~     facilitate the implementation of respiratory-synchronized techniques such as gating, tracking~     and four-digital optimization.~   "
25978|NCT03226912|"~     As mortality from critical illness has reduced, the importance of measuring disabilities~     (cognitive, functional and psychological) in surviving critically ill patients has become~     more important. Currently, the causes, long-term effects and frequency of disabilities in~     patients surviving ICU in Australia are unknown. In the US and UK, studies have been~     undertaken to assess the effects of specific long-term outcomes, such as functional~     disability and depression, which found long-term disabilities were much higher than baselines~     (pre-illness function) and ongoing at five years after ICU discharge. In order to improve~     quality of life of ICU survivors and ensure that medical specialists apply appropriate~     interventions to reduce the cost of these surviving patients on the community, the PREDICT~     management committee proposes the introduction of a patient-reported outcomes registry.~   "
25979|NCT03226899|"~     This study evaluates the safety and efficacy of lesinurad administered with an XOI versus a~     placebo plus an XOI in gout participants who have moderate renal impairment and who are not~     at target level of sUA.~   "
25980|NCT03226886|"~     This is a translational study, which, aims to develop prognostic and predictive biomarkers~     for patients with renal cell carcinoma (RCC).~   "
25981|NCT03226873|"~     This pilot study will assess the feasibility and acceptability of a peer outreach and~     navigation intervention designed to increase access and promote HIV pre-exposure prophylaxis~     (PrEP) uptake among street-based cisgender and transgender women involved in transactional~     sex.~   "
25982|NCT03226860|"~     This research study will see if electrical stimulation increases heel strike (heel hits the~     floor first when walking), decreases limp, helps muscle contraction, and improves balance in~     children with a hemiplegic leg. An experimental electrical stimulation device called the Gait~     MyoElectric Stimulator (GMES) will be used to stimulate the shin and calf muscles.~   "
25983|NCT03226847|"~     Pulmonary vein isolation (PVI) has become a common and effective treatment for paroxysmal and~     persistent atrial fibrillation (AF), particularly in patients with drug-refractory disease.~     Intense endurance exercise is a known risk factor for atrial fibrillation. In general, these~     athletes poorly tolerate most common antiarrhythmic drugs used for atrial fibrillation~     control and often PVI is recommended for durable management. While the efficacy of PVI in~     athletes is similar to the general AF population, some athletes with lone atrial fibrillation~     report a reduction in subjective exertional capacity following PVI, despite maintenance of~     sinus rhythm and absence of pulmonary vein stenosis on imaging. The investigators hypothesize~     that PVI may alter pulmonary vein function and affect peak exercise performance.~      The investigators propose a small, prospective study of endurance athletes undergoing antral~     PVI for treatment of lone atrial fibrillation. Peak metabolic performance and pulmonary vein~     function will be assessed pre- and post-PVI by metabolic stress testing and cardiac MRI,~     respectively.~   "
25984|NCT03226834|"~     Anxiety is a psychologic and physiological state that could be characterized by somatic,~     emotional, cognitive and behavioral components. Surgery, as well as waiting for surgery is an~     anxiogenic situation encountered by 60 à 80 % of the patients. High levels of anxiety lead to~     negative physiological signs that slow down healing, lowers imune response and increases~     post-surgery infection. Anxiety also increases pain and post-surgery morbi-mortality.~     Drug-induced sedation is frequently recommended to lower anxiety. The anxiolytic effect of~     alternative treatment such as musicotherapy has been demonstrated in several randomized~     control trials. Nevertheless, most of these studies have investigated the effect of~     musicotherapy in groups with our without musical listening.~      In the present study, investigators assume that a personal musical sequence composed by~     favourite songs of the patients could have beneficial effect on presurgical anxiety than~     selective sequence of the medical device MUSIC CARE.~      In this study, the anxiolytic effect of predefined U musical sequences that alternate slow~     and faster music tracks (medical device MUSIC CARE) are compared to patient's play-list, in~     women with planned gynecological surgery.~   "
25985|NCT03226821|"~     In this study, the investigators will examine the effect of therapy with the Growth Hormone~     Releasing Hormone (GHRH) analog tesamorelin on body composition in patients with HIV~     lipodystrophy and central adiposity. This study is a single arm prospective study of~     tesamorelin therapy of patients with HIV lipodystrophy. Subjects will do body composition~     testing, adipose tissue biopsy, metabolic rate measurements and insulin sensitivity~     assessment before, 6 and 12 months after daily injections of tesamorelin 2 mg by subcutaneous~     injection.~   "
25986|NCT03226808|"~     The objectives of this study are to obtain clinical performance (outcomes) data and~     survivorship for commercially available Vivacit-E (HXPE) liners. This will be done by~     analysis of polyethylene wear, validated outcome measurement tools, radiographs, and reported~     adverse events data.~   "
26104|NCT03225274|"~     The study evaluates the effectiveness of Breathing Exercises as Therapeutic Play on~     respiratory Status among children with Lower respiratory Tract Disorders. patient were~     allocated into two groups- Experimental group and Comparison group. Experimental Group~     received Breathing Exercises as Therapeutic Play after administration of Nebulization therapy~     and comparison Group received no Breathing Exercises.~   "
25987|NCT03226795|"~     Background Cystic fibrosis is a life-threatening genetic disorder responsible for pulmonary~     failure and multi-systemic complications involving specific and large medical care burden. To~     date, no program has shown its effectiveness in improving therapeutic adherence. A new~     approach to develop a co-constructed program involving patients and professionals may~     contribute to improve therapeutic adherence.~      Objectives The aim of the MUCOBS-Trial project is to create a program to increase therapeutic~     adherence and to evaluate its efficacy in adult patients with cystic fibrosis in 3 CF centers~     in France.~   "
25988|NCT03226782|"~     Among the possibilities of intervention to minimize the effects of cancer treatment, the~     exercises are efficient in improving the physical fitness and quality of life of the elderly~     in treatment. The goal is to compare the effects of two home physical exercise protocols on~     quality of life and physical fitness of elderly people with breast cancer who are in hormone~     use. A study was carried out at the Institute of Integral Medicine Professor Fernando~     Figueira (IMIP) within the Professional Master Program in Palliative Care Associated with the~     Residency Program in Health, which evaluated the effectiveness of a protocol of 29 exercises~     with walking sessions, performed at home , In the quality of life and physical fitness of the~     elderly in the treatment of breast cancer. The results of the mentioned research showed that~     the elderly showed improvement both in quality of life and physical fitness.~      In view of the results and the clinical and functional kinetic observation of these patients,~     the hypothesis was that a shorter intervention protocol, with fewer exercises with fewer~     repetitions and a lower degree of difficulty can bring results similar to those found,~     requiring a shorter time In the accomplishment of the exercises, which can favor the~     adherence to the protocol by the patients, still achieving positive results in their quality~     of life and physical fitness.~      The elderly will undergo evaluations to characterize the sample through questionnaires, the~     physical fitness assessment will be performed through the Senior Fitness Test (SFT) and~     anthropometric evaluation before (beginning of the research), in the 6th week and after the~     12th week of the research. It will be offered the elderly, instructional material developed~     for this research - printed manual. It will consist of a routine of 12 exercises to be~     performed autonomously for range of motion and muscular fitness, using the environmental~     resources of the home. All control and training guidelines for using the manual will be~     offered through an introductory lecture and subsequent weekly telephone contacts (twice a~     week). Participants should complete their respective program for a total period of 12 weeks~     and mark in the manual how often they performed the exercises. The control group used a~     protocol with 29 home exercises in a longer manual. The results will be obtained from the~     statistical package SPSS 10.0 for Windows and a p <0.05 will be accepted.~   "
25989|NCT03226769|"~     This study will compare the safety and efficacy of TrueTear to standardized moist heat~     compress (Thermalon® Dry Eye Compress) for the treatment of Meibomian Gland Disease (MGD).~   "
25990|NCT03226756|"~     Recurrent and/or metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) are a common~     clinical situation and although this group of patients has very heterogeneous disease~     characteristics, they share a dismal prognosis with a median survival time around 6-11 months~     and a relatively poor quality of life.~      Immunotherapy approaches have recently demonstrated clinical efficacy in more than twenty~     cancer types, including melanoma, renal cell carcinoma, non-small cell lung cancer (NSCLC)~     and SCCHN. Nivolumab demonstrated significant overall survival benefit as treatment for~     recurrent SCCHN in a randomized phase III Study CA209141 conducted on a cohort of 361~     patients (240 in the nivolumab arm and 121 in the standard therapy arm), presenting this~     condition and whose disease had progressed within 6 months after platinum-based chemotherapy.~     In this study, treatment with nivolumab resulted in significantly longer survival than~     treatment with standard therapy with a median overall survival of 7.5 months vs 5.1 months~     (p=0.01).~      The main objective of the study is to provide additional insight into the frequency of~     high-grade AEs related to nivolumab and their outcome, and thus supplement the growing safety~     database of nivolumab-treated recurrent and/or metastatic squamous cell carcinoma of the head~     and neck patients.~   "
25991|NCT03226743|"~     The aims of COMET are the implementation and evaluation of effectiveness and~     cost-effectiveness as well as processes of a collaborative and stepped care model for~     depressive, anxiety, somatoform and/or alcohol abuse disorders within a multiprofessional~     network in comparison to routine care. In a cluster-randomized controlled effectiveness trial~     750 patients will be recruited by 50 general practitioner practices and followed with a~     prospective survey at four time points. The primary outcome is the change in health-related~     quality of life from baseline to 12-month follow-up. Secondary outcomes include~     disorder-specific symptom burden, response, remission, functional quality of life,~     cost-effectiveness, evaluation of processes and other clinical and psychosocial variables.~   "
25992|NCT03226730|"~     This study entails a quasi-experimental, mixed-methods (i.e., complementary quantitative and~     qualitative) outcome evaluation to assess the efficacy of the Reaching Married Adolescents~     (RMA) Interventions developed and implemented by Pathfinder International to increase~     contraception use and contraception use intentions among married adolescent girls ages 13-19~     in three rural districts of the Dosso region of Niger. Intervention models~     (gender-synchronized household visits and small groups) will be tested using a randomized~     4-arm outcome evaluation design; Arm 1 will receive household visits, Arm 2 will receive~     small groups; Arm 3 will receive household visits plus small groups, and Arm 4 will serve as~     the control group and will not receive any intervention. The quantitative component will~     consist of collecting quantitative baseline and 16-months follow-up survey data from randomly~     selected married adolescent girls (n=1200) and their husbands (n=1200) who are participating~     in each Arm of the study. Qualitative elements will include ethnography at two time points~     and semi-structured in-depth interviews half way through intervention implementation. A~     costing and cost effectiveness analysis will also be conducted to evaluate which intervention~     provides the largest gain in the primary outcomes for each dollar spent.~   "
25999|NCT03226639|"~     The ablation of atrial fibrillation (FA) by disconnection of pulmonary veins is a burgeoning~     intervention. It allows a long-term treatment of this arrhythmia with a success rate of about~     80%. There are, nevertheless, some recidivism.~      Risk factors for recidivism are poorly codified and need further research. Indeed the~     identification of factors of poor prognosis could lead to not propose this procedure to the~     patients who present them and at least to inform them of an increased risk of failure.~      To date, aortic stiffness has not been studied in the context of assessing the risk factors~     for FA recurrence after ablation. On a physiopathological level, the aortic stiffness leads~     to increase left ventricle's post-load. Cardiac remodeling was observed with diastolic~     dysfunction and increased left atrial size. That may constitute a substrate for FA~     recurrence.~      In the literature, aortic stiffness can be measured in several ways:~        1. Measurement of systolo-diastolic variation of the inner diameter of the aorta by scanner~          or transesophageal Echography (ETO).~        2. Measuring of the Pulse Wave Velocity.~        3. Measurement of aortic calcifications.~      The investigators propose to evaluate the impact of aortic stiffness on the recidivism of FA~     6 months after ablation procedure performed in the Croix-Rousse cardiology's department.~   "
25993|NCT03226717|"~     The prevalence of HCV infection in Egypt is 14.7%. HCV is both a hepatotropic and a~     lymphotropic virus, it may exert a chronic stimulus on the immune system with both T and B~     lymphocyte alterations. In addition to cryoglobulinaemic vasculitis, HCV may trigger~     different immune-mediated extrahepatic disorders. A variable combination of HCV with other~     unknown enviromental and/or hostgenetic cofactors may lead to different clinical phenotypes~     that characterise HCV syndrome. Patients who have HCV -related arthropathy are accounted for~     by 2 clinical subsits: Rheumatoid-like arthritis and Cryoglobulin-related arthritis. Patients~     with mild arthritis, conservative manegement using analgesics with anti- inflammatory~     activity is recommended. In patients who have contraindications to their use, short term low~     dose prednisone is an option. In HCV infection with concomitant RA, ACR guidelines published~     in 2008 provided recommendations pertaining to these of DMARDs that are based on the severity~     of liver disease using the child- pugh- turcotte classification. For patients with severe~     cryoglobulinaemia such as severe debilitating disease or systemic in improvement, a~     combination of immunosuppressive and antiviral therapy is preferred. It has been found that~     antiviral therapy with interferon immunosuppressive and antiviral therapy is preferred. It~     has been found that antiviral therapy with interferon improves the musculoskeletal~     manifestations in HCV arthropathy. The DIrect antiviral agents seems very promising in~     treatment of HCV arthropathy. As HCV genotype 4 is the most common genotype in Egypt, the~     effective optional antiviral agents are sofosbuvir, daclatasvir, ledipasvir, paritaprevir,~     velpatasvir, ombitasvir and simeprevir.~   "
25994|NCT03226704|"~     Background:~      Leukapheresis is a procedure to separate and collect white blood cells. It is the first step~     in a treatment called CAR (chimeric antigen receptor) T-cell therapy. CAR-T therapy may be~     offered to people when their cancer comes back. The collected T-cells are used to make a~     special version of T-cells called CARs. Researchers want to collect these cells from people~     who may become eligible for a CAR T-cell study in the future.~      Objective:~      To identify people who have a high likelihood to benefit from CAR T-cell therapy early in~     their disease course and collect and store a T-cell product.~      Eligibility:~      People ages 4-30 with a form of leukemia or lymphoma that has not been cured by standard~     therapy~      Design:~      Participants will be screened with medical history, physical exam, and blood and urine tests.~     Some will also be screened with:~      X-rays~      Scans~      Spinal fluid samples~      Bone marrow aspiration and biopsy~      On this study, participants will have leukapheresis. A needle will be placed into the arm.~     Blood will be collected and go through a machine. White blood cells will be taken out by the~     machine. The plasma and red cells will be returned to the participant through a second needle~     in the other arm. The procedure will take 4-6 hours. Some participants may have a central~     line (catheter) inserted which is needed to do the leukapheresis procedure, instead of the~     needles in the arms-especially if they are smaller. For a central line placement, a long thin~     tube is inserted through a small incision into the main blood vessel leading into the heart~     that would allow access to the blood to do the leukapheresis procedure.~      Participants cells will be processed and frozen for future use in a CAR T-cell therapy study.~   "
25995|NCT03226691|"~     The constitution of blood relies upon hematopoietic stem cells (HSCs), which stay in the bone~     marrow and differentiate to all lineages of peripheral blood cells. HSC transplantation is~     the only curative option currently available for sickle cell disease (SCD) patients either~     via allogeneic HSC transplantation or HSC-targeted gene therapy. Granulocyte-colony~     stimulating factor (G-CSF)- mobilized HSCs are frequently utilized in the adult setting of~     HSC transplantation because of the faster hematologic recovery as compared to bone marrow. As~     an autologous HSC source for gene therapy, bone marrow harvest has been generally employed~     since G-CSF has been prohibitive in SCD patients due to granulocyte stimulation and the~     associated reports of vaso-occlusive crises, multi-organ failure, and death. However, when~     bone marrow harvest is used, the amounts of collected cells are limited and anesthesia is~     required. In order to obtain HSCs in large numbers without anesthesia, patients will undergo~     mobilization followed by large volume apheresis. Plerixafor is an alternative treatment for~     mobilization without direct stimulation to granulocytes, and it is theoretically applicable~     for SCD patients. The primary endpoint of this study is to obtain sufficient amounts of HSCs~     collected from the peripheral blood in SCD patients after plerixafor~      mobilization with an acceptable safety profile. The harvested products will be stored as~     backup for patients undergoing gene therapy as well as allogeneic HSC transplantation.~   "
25996|NCT03226678|"~     This study is to assess the safety, tolerability, preliminary efficacy, and pharmacokinetics~     of APL-2 in subjects with warm Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease~     (CAD).~   "
25997|NCT03226665|"~     Small bowel obstruction (SBO) is a common presentation to the emergency department (ED) and~     represents 15% of hospital admissions for acute abdominal complaints.~      Plain radiography, although traditionally recommended as the initial diagnostic imaging~     modality of choice, has a sensitivity of only 59% to 77%. When clinical and radiographic~     assessment is indeterminate, computed tomography (CT) becomes the test of choice due to its~     superior resolution and increased ability to identify both obstruction and its aetiology Aim:~     this is a prospective study in a sample of patients presenting to the emergency department~     (ED) with abdominal pain, vomiting, or other symptoms suggestive of a SBO (history of~     previous surgeries, constipation, abnormal bowel sounds, and abdominal distention). Patients~     will be evaluated with US prior to x-ray and CT, with possible diagnostic confirms by~     endoscopy or surgery.~   "
25998|NCT03226652|"~     This study aims to determine the prevalence and prognosis of heart failure with preserved~     ejection function (HFpEF) among patients being assessed for sleep disordered breathing (SDB).~   "
26023|NCT03226327|"~     This study is an one arm, self-controlled preliminary trial. Hypertension patients will be~     categorized into three types, not taking antihypertension drugs with normal renal function,~     taking antihypertension drugs with normal renal function, and taking antihypertension drugs~     or not with abnormal renal function. Each category includes 30 hypertension patients. Based~     on renal function, the investigators provide the ManLiKang containing potassium chloride to~     patients with normal renal function, and provide the ManLiKang not containing potassium~     chloride to patients with abnormal renal function. All hypertension patients will use the~     formula salt with limited sodium ManLiKang in six weeks, and will be followed up at 1, 2, 4~     and 6 weeks to assess the safety, the effect of reducing blood pressure and the change of~     24-hour urine sodium.~   "
26000|NCT03226626|"~     This is a multicenter randomized clinical trial (RCT) comparing two modes of antibiotic~     delivery:~      Control: Intravenous Antibiotic Delivery (IVAD) Treatment: IVAD + TAAD The Food & Drug~     Administration (FDA) has approved our Investigational New Drug (IND) application to conduct~     this RCT. An IND application was necessary because subcutaneous injection of antibiotics in~     general, and cefazolin and metronidazole in particular are considered to be off-label. In~     addition, the tumescent formulation of cefazolin (1gm) and metronidazole (500mg/100ml) in a~     dilute solution of lidocaine (1gm), epinephrine (1mg) in 100ml and sodium bicarbonate~     (10mEq/10ml) added a 1000ml bag of 0.9% sodium chloride (total volume 1210ml) is also~     considered off-label. This trial will also prospectively study the HK Surgical SubQKath, an~     over-the-needle subcutaneous catheter specifically designed to deliver relatively large~     volumes of a relatively dilute TAAD solution. The TAAD trial will document the safety and~     efficacy of the HK SubQKath~   "
26001|NCT03226613|"~     Background: The incidence of human papilloma virus-driven oropharyngeal cancer (HPV-OPC), a~     type of head and neck cancer, is rapidly increasing within the US. Currently, there are no~     screening methods for early detection. HPV16 E6 antibodies combined with ultrasound imaging~     may be a promising method for early detection of HPV-OPC. However, prior to testing HPV16 E6~     antibodies and ultrasound for HPV-OPC screening, larger studies are needed to further~     validate the utility of these methods in the diagnostic setting among patients with suspected~     and/or symptomatic HPV-OPC.~      Objective/Hypothesis: To investigate two promising screening modalities for the detection of~     HPV-OPC, transcervical ultrasound and HPV16 E6 antibodies. The investigators hypothesize that~     both ultrasound and HPV16 E6 antibodies will be highly sensitive for the detection of~     symptomatic HPV-OPC.~      Specific Aims: (1) Determine the sensitivity of ultrasound to characterize OPC tumors~     compared to current standard imaging modalities among patients with suspected or confirmed~     OPC. (2) To determine the sensitivity and specificity of HPV16 E6 antibodies for HPV-OPC. (3)~     Determine the sensitivity of ultrasound to detect HPV-OPC compared to current standard~     imaging modalities among patients that present with a neck mass and unknown primary tumor.~   "
26002|NCT03226600|"~     The purpose was to compare root coverage outcomes between autogenous connective tissue graft~     (CTG) and decellularized human dermis (OrACELL™) in areas of facial gingival recession.~   "
26003|NCT03226587|"~     Ultraviolet light exposure was shown to be able to release nitric oxide from the skin into~     the blood stream and lead to an acute decrease in blood pressure and increase in vascular~     function. Additionally, preliminary work indicates that UV free blue light also releases~     nitric oxide in the skin mediating similar effects as seen with ultraviolet light A(UVA). It~     is the goal of the present experimental study to investigate the hemodynamic effects of whole~     body blue light exposure including blood pressure, endothelial function and vascular~     stiffness. Therefore, healthy volunteers will be exposed to 30 minutes whole body blue light~     (453 nm wavelength) and the change in blood pressure and endothelial function (Flow mediated~     dilation (FMD)), heart rate, forearm-blood flow, forearm vascular resistance central blood~     pressure and vascular stiffness ( pulse wave analysis by sphygmocor) will be measured.~      In this randomized controlled cross-over study, 20 healthy subjects aged 30 to 60 years will~     participate.~   "
26004|NCT03226574|"~     The study is a multicenter, open-label Phase 1b single dose escalation safety study for adult~     subjects with intractable pain associated with cancer in any area below the mid-thoracic~     level who meet all other eligibility criteria.~   "
26005|NCT03226561|"~     Patients who underwent presbyopic correction with bilateral trifocal intraocular lenses~     implantation are supposed to have sufficient uncorrected vision capacity for activities of~     daily living (ADLs) that require near vision acuity (NV), (ie. book reading). However, it is~     known that light intensity and temperature has a great impact on near vision capacity.~     Primary objective of this study is to identify the optimal task lighting conditions (in terms~     of light intensity and temperature) for ADLs that demand near vision acuity for a sample of~     patients who underwent presbyopic correction with bilateral trifocal intraocular lenses~     implantation~   "
26006|NCT03226548|"~     Paycheck Plus (PP) is a randomized controlled experiment (RCT) that explores the health and~     longevity effects associated with increasing the Earned Income Tax Credit (EITC). EITC is a~     national program that provides tax credits to low-income, disproportionately minority workers~     who file taxes. EITC is politically popular, having received bipartisan support. The EITC,~     along with state supplemental programs, have 7 million American families out of poverty. The~     investigators' preliminary data analyses show that the EITC has had large population health~     impacts, reversing declines in self rated health and survival among the poorest Americans.~   "
26007|NCT03226535|"~     The objective of this research is to use the Clear Guide SCENERGY technology, an FDA approved~     Ultrasound-CT fusion imaging system, that allows the user to fuse CT images onto a real-time~     ultrasound that is being performed on the patient. This fusion system will be used to perform~     ultrasound guided needle placements for patients undergoing percutaneous CT guided~     needle-based intervention. This study will consist of 20 patients, 10 patients using the CGM~     SCENERGY US-CT system and 10 patients using guidance only. The primary goal of the study is~     to prove that the new imaging fusion system is comparable to using either CT or US guidance~     alone to guide needle placement.~   "
26008|NCT03226522|"~     This is a multi-center, randomized, double-blind, placebo-controlled study, to assess the~     efficacy and safety of AXS-05 in the treatment of agitation in patients with Alzheimer's~     disease.~   "
26024|NCT03226314|"~     In its report dated april 2014, World Health Organization confirms antibiotic resistance~     dissemination in all parts of the world, in hospitals and in community and worries about a~     possible comeback to a pre-antibiotic era during the 21st century. For the last 15 years,~     third-generation cephalosporins resistant enterobacteriaceae (3GCREB) prevalence is~     continuously increasing. Community 3GCREB prevalence has not been studied whereas several~     observations made in Reunion Island hospital suggest a diffusion in community. In this~     situation of world-wide and regional extension of bacterial resistance, the investigator~     offers to study bacterial resistance to antibiotic in Reunion Island community.~   "
26025|NCT03226301|"~     The aim of the current trial is to evaluate if combination treatment with venetoclax +~     ibrutinib in patients with relapsed or refractory chronic lymphocytic leukemia (RR CLL) can~     lead to MRD negativity, which may induce long lasting remissions for MRD-negative patients~     randomized to stopping treatment after 15 induction cycles.~   "
26009|NCT03226509|"~     Several factors are barriers to effective Hepatitis C care: 1) The majority of Hepatitis C~     Virus (HCV)-positive patients (45-85 percent) are unaware that they are infected; 2) Only a~     small minority of those in need of treatment receive it; 3) Members of minorities and older~     patients are even less likely to receive needed care; and 4) Until recently, even those who~     were treated had a low chance of clearing the virus or achieving cure; 5) It is possible that~     older attitudes and expectation of futility might continue to persist among patients and~     provider in primary care settings.~      Community Health Centers are often the most culturally appropriate and accessible choices,~     particularly for underserved populations, with the benefit of ongoing trust and relationships~     with patients. Therefore, these can be ideal places to deliver complex HCV care if they~     possess the needed expertise. However, most community-based primary care and community health~     centers lack access to Hepatitis C evaluation and treatment services, leading to a major~     public health problem.~      Thus, investigators propose to implement and evaluate a pragmatic trial to implement and~     evaluate a multi-disciplinary model for HCV treatment at Currently, the treatment initiation~     rates at each of these sites is estimated as less than 10%. The investigators hypothesize~     that our project will increase the rate of participation in all the steps of the HCV care~     cascade and ultimately lead to more than doubled rates of treatment uptake~   "
26010|NCT03226496|"~     The aim of the proposed supplemental study is to test a single session motivational~     interviewing (MI) program designed to promote the acceptance and use of PrEP for high-risk~     young Black men who have sex with men (YBMSM) and to determine whether previous assignment to~     study condition moderates these outcomes.~   "
26011|NCT03226483|"~     INTRAMET examines prospectively the effectiveness of an intraoperative radiotherapy immediate~     after the surgical resection of brain metastases. Patients won't receive further radiation~     therapy of the intraoperatively treated lesion.~   "
26012|NCT03226470|"~     This is an open-label and triple cohort study of the safety and efficacy of T27 and T512 to~     possibly treat cervical intraepithelial neoplasia(CIN).~   "
26013|NCT03226457|"~     The RECEDE-CHF trial is a single centre phase IV, randomised, double-blind,~     placebo-controlled, crossover trial conducted in NHS Tayside, Scotland comparing~     empagliflozin 25mg, to placebo in patients with Type 2 Diabetes and mild Chronic Heart~     Failure with left ventricular systolic dysfunction who are already on a loop diuretic. Renal~     physiological testing will be performed at two points on each arm to assess the effect of~     empagliflozin, on urinary volume, compared to placebo. The secondary outcomes are to assess~     the effect of empagliflozin in addition to loop diuretics on natriuresis, to assess the~     safety of add-on SGLT2 inhibitor therapy as measured by changes to serum creatinine and eGFR,~     to assess effects of empagliflozin on urinary protein/creatinine ratio, albumin/creatinine~     ratio and cystatin C when compared to placebo.~   "
26014|NCT03226444|"~     The objective of this study is to evaluate the efficacy and safety of two strengths of~     Lacripep™ ophthalmic solution versus placebo administered three times daily for four weeks in~     subjects with a diagnosis of Dry Eye associated with documented Primary Sjögren's Syndrome~   "
26015|NCT03226431|"~     To treat an intermediate size patient population of bilateral lung transplant patients with~     CLAD-0.~   "
26016|NCT03226418|"~     This phase II trial studies how well cytarabine and idarubicin or decitabine work in treating~     patients with acute myeloid leukemia or high-risk myelodysplastic syndrome. Drugs used in~     chemotherapy, such as cytarabine and idarubicin, work in different ways to stop the growth of~     tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them~     from spreading. Decitabine may stop the growth of cancer cells by blocking some of the~     enzymes needed for cell growth. Giving patients cytarabine and idarubicin or decitabine may~     work better in treating patients with acute myeloid leukemia or high-risk myelodysplastic~     syndrome based on clinicogenetic risk stratification.~   "
26017|NCT03226405|"~     The MGH Cancer Center's patient navigation (PN) program, utilizes specially trained~     community-based personnel to improve cancer care in underserved communities by increasing~     cancer screening and removing barriers to timely care. This program incorporate rigorous~     evaluation to demonstrate the impact of innovation in healthcare delivery.~   "
26018|NCT03226392|"~     A randomized, multicenter, double-blind, placebo- controlled parallel-group study to~     determine the efficacy and safety of QAW039, compared with placebo, when added to~     standard-of-care (SoC) asthma therapy in adult and adolescent (≥ 12 years) patients with~     uncontrolled asthma with respect to change from baseline in forced expiratory volume in 1~     second (FEV1) at the end of 12 weeks of treatment.~   "
26019|NCT03226379|"~     The DREAMM project is investigating whether point of care tests within a diagnostic and~     treatment algorithm together with support and additional training of laboratory and clinical~     staff will reduce two and ten week all-cause mortality of HIV-associated meningo-encephalitis~     in LMICs.~   "
26020|NCT03226366|"~     Sepsis is a common syndrome resulting from a dysregulated response to infection. The timing~     of antibiotic initiation is an important determinant of outcomes for patients presenting to~     the emergency department with sepsis. The potential effect of care reorganization on very~     early care for sepsis is unknown. This study will investigate whether multidisciplinary~     coordination of the initial patient evaluation in the emergency department influences~     door-to-antibiotic time for septic patients.~   "
26021|NCT03226353|"~     The objective of the study is to determine if habitual or adapted contact lens wearers of~     Omafilcon A can be confidently refit into Somofilcon A lenses and be successful after one~     week of daily wear.~      The primary outcome variables for this study are:~        -  Investigator responses to refit questions;~        -  Lens fit.~   "
26022|NCT03226340|"~     Evaluation of the Efficacy and Safety of S-amlodipine+Chlorthalidone Combination Therapy and~     S-amlodipine+Telmisartan Combination Therapy in Hypertensive Patients Inadequately Controlled~     With CCB(Calcium Channel Blocker) Monotherapy~   "
26041|NCT03226093|"~     Stromal vascular fraction (SVF) can be isolated from fat (adipose) tissue in an outpatient~     in-clinic procedure. Platelet rich plasma (PRP) can be isolated from peripheral blood. The~     SVF includes a variety of different cells and growth factors where the adipocyte (fat cell)~     population has been removed. The use of SVF in the clinic for a variety of indications is~     analyzed for incidences of safety and tolerability.~   "
26026|NCT03226288|"~     While human body receives large external force or motions, minor injuries to the soft tissues~     will be produced and will lead to acute or chronic inflammation reactions. Plantar fasciitis~     is the most common foot diseases in normal population. Plantar fascia is a tight band-like~     soft tissue that crosses between the bony surfaces of the bottom of the foot with thick~     ligament-like structure substantially. Various reasons will induce the happening of plantar~     fasciitis including native bone structure, aging, athletic motions and injuries. Indeed,~     diagnosis of chronic heel pain remains challenging due to the complex structures of the foot.~     Therefore, it is widely accepted that diagnostic imaging such as ultrasound and computed~     tomography offer important orthopedic information for clinical assessments of soft tissues~     and bone. Even though there is no single treatment shows the highest level of evidence for~     plantar fasciitis, wearing of insoles or orthotics are highly suggested for clinical therapy.~     Common custom-made insoles are manufactured with polymeric materials based on standing~     foot-pressure distribution. However, this method strongly depends on experience of doctors or~     physical therapists and usually time-consuming. In addition, modern medical researches tend~     to combine the information of both soft (pressure distribution) and hard (orthopedic) tissues~     for designing of orthotics and other medical assistive devices because of the complicity of~     the limb motion and structures. Therefore, investigators aim at developing integrated 3D~     system that provides a 3D limb data model with high-resolution appearance scanning and~     orthopedic information for designing of medical assistant devices. This model composes of 3D~     surface scanning, 3D bony structure scanning, and soft tissues characteristic mechanical~     properties. By developing this system, the 3D model is also highly applicable to the other~     parts of human assistant devices. It will bring the enormous impact to the associated medical~     field and create excellent economic value.~   "
26027|NCT03226275|"~     This is a Phase I, open-label, randomized, 2-period, 2-sequence, crossover study to~     demonstrate bioequivalence (BE) between the bisoprolol-amlodipine fixed-dose-combination~     (FDC) tablet (investigational product) and bisoprolol and amlodipine tablets administered~     concomitantly (comparators) given as a single oral dose in fasting and fed state.~   "
26028|NCT03226262|"~     This is a prospective, observational, multi-center, single-arm, clinical trial designed to~     assess the efficacy of FFRangio in measuring FFR obtained from angiography compared to~     Invasive FFR for diagnosing hemodynamically significant coronary stenosis.~   "
26029|NCT03226249|"~     The purpose of this research study is to evaluate a new drug Pembrolizumab in combination~     with chemotherapy, for the treatment of newly diagnosed Hodgkin lymphoma. The chemotherapy~     regimen is called ?AVD? and includes three drugs: adriamycin, vinblastin, dacarbazine.~     Pembrolizumab is currently FDA approved for the treatment of some patients with melanoma,~     lung cancer and head and neck cancer, but has not yet been approved for the treatment of~     Hodgkin Lymphoma. The ?AVD? regimen of chemotherapy is currently FDA approved for the~     treatment of newly diagnosed Hodgkin lymphoma, but has not yet been investigated in~     combination with pembrolizumab for this disease. For patients who have a new diagnosis of~     Hodgkn?s Lymphoma, multi-agent chemotherapy is recommended. Also, for patients who do not~     have a complete response to chemotherapy (meaning there is still evidence of disease on PET~     scans performed at the end of treatment), radiation is sometimes recommended. Furthermore,~     the rare patient who relapses after chemotherapy requires treatment with high dose~     chemotherapy and a transplant.~   "
26030|NCT03226236|"~     Single center, open-label Proof of Principle phase II trial to assess objective response~     (ORR).~      Three daily doses boost radiotherapy (XRT) at 6-12 Gy to at least 1, and up to a maximum of~     5, metastatic fields, will be administrated on days -4 -3 -2 or -3 -2 -1 before the first and~     the third cycle of vaccine+IL-2. The first day of administration of vaccine is day +1 and of~     IL-2 is day +2.~      Treatment vaccine plus IL-2 (dose 18 MIU/m2/day in 500cc by continuous IV infusion for 72~     hours) will be administered every 3 weeks up to 6 cycles.~      Total duration of the trial: 36 months~        -  Enrolment period: 24 months~        -  Treatment: maximum of 6 cycles (5 months) per patient~        -  Follow-up every three months until patient died (follow-up until PD and only survival~          contacts and subsequent therapy for metastatic disease after PD).~   "
26031|NCT03226223|"~     This investigation will be the first study assessing genetic modulation of naltrexone's NTX~     effects upon the abuse liability of a stimulant drug (methamphetamine). The study team will~     assess the ability of oral NTX to block the reinforcing and positive subjective effects of~     intranasal (IN) methamphetamine (30mg/70kg). This investigation could identify an important~     Gene x Pharmacological interaction, contributing to the personalization of stimulant abuse~     pharmacotherapy.~   "
26032|NCT03226210|"~     To compare the effect of the rapid-acting insulin analogues (RAIAs) NovoRapid (aspart) and~     Prandilin (lispro) on glycemic variations by Continuous glucose monitoring system (CGMS) in~     continuous subcutaneous insulin infusion (CSII) with metformin intensive therapy in newly~     diagnosed type 2 diabetes mellitus (T2DM).~   "
26033|NCT03226197|"~     Every year, efforts are made to resuscitate about 30,000 people when their hearts stop~     outside of the hospital environment ('out-of-hospital cardiac arrest'). Early damage to the~     brain due to 'oxygen starvation' (seemingly paradoxically) gets worse when blood flow is~     restored. Of the 6,350 survivors admitted to intensive care units, 46% die from brain damage,~     and half of those who survive suffer long-term brain damage. Apart from avoiding a high~     temperature, nothing has been found which can protect the brain or improve outcome.~      'Ketones' are chemicals naturally produced in the body from fat during starvation. They act~     as an energy source, but also as regulators of metabolism, and appear to protect cells from~     damage when oxygen supplies are scarce, or when blood flow is restored. The investigators~     want to see whether a ketone drink will protect the brain after out-of-hospital cardiac~     arrest.~      The investigators will study 10 cardiac arrest patients, and participants will be given the~     ketone drink via a feeding tube (which is routinely passed into the stomach in such cases).~     The investigators shall check that the drink is absorbed, and measure the ketone levels in~     the blood. The investigators will also measure important aspects of blood chemistry~     (including pH and blood sugar) and collect data on brain (electrical recordings called 'EEG'~     and 'SSEP') and heart function (ultrasound scans or 'echocardiographs') - both of which it is~     hoped might improve - in order to demonstrate that this is possible if it is to be included~     in a subsequent large trial. The study will be scrutinised by world experts in the field, who~     have also helped design the study.~      If this pilot study is a success, the investigators will apply to a major grant body to fund~     an appropriately-powered randomised controlled trial to determine whether ketones improve~     neurological outcome and survival in these patients. Results will also allow similar studies~     to be planned in heart attack, stroke and traumatic brain injury.~   "
26042|NCT03226080|"~     Surgical repair of hip fractures may be performed with various anesthetic techniques, but are~     most commonly completed under general anesthesia (GA) or neuraxial anesthesia (NA). Numerous~     prospective and retrospective studies demonstrate improved morbidity and mortality when NA is~     used; however, many surgeons prefer the use of GA with neuromuscular blockade (NMB) due to~     the perception of better operative conditions. This study aims to compare the operative~     conditions obtained from the use of combined GA and spinal with NMB vs. the use of GA with~     spinal without NMB. 84 patients will all receive a single shot spinal and GA and then will be~     randomized to receive either NMB or placebo. The fracture reduction time will be measured.~   "
26105|NCT03225261|"~     This randomized, parallel, double-blind, placebo-controlled trial aims to determine the~     effects of daily administration of citrus extract over a period of 8 weeks on~     gastrointestinal health in 2 different patient groups.~   "
26034|NCT03226184|"~     Background:~      Even today, postoperative infection is the commonest complications after surgery although all~     aseptic precautions are taken and causes significant postoperative morbidity, mortality,~     prolongs hospital stay, and increases costs. Infections that are related to orthopaedic~     procedures are considered particularly severe when implantation materials are used which~     further increases the risk of infection and holds the risk of biofilm formation. This is of~     particular concern since biofilm-mediated infections are difficult to diagnose and effective~     treatments are lacking. Therefore, new strategies for implant infection are currently being~     researched worldwide. In this study the relatively new approach for infection control by~     using an Er:YAG laser was adapted to an orthopaedic and traumatologic setting. This laser~     vaporizes all water containing cells in a very effective, precise and predictable manner and~     shows only a minimal thermal damage.~      Methods:~      For preliminary testing 42 steel pins and 42 plates were cultivated with cocultures for 2~     weeks. The minimally necessary laser energy for biofilm removal was determined. We~     subsequently compared the effectiveness of biofilm removal with the Er:YAG laser and a~     cleansing of the metal implants with Octenidine soaked gauze. The temperature rise within the~     metal during the laser procedure was also measured.~      In order to achieve an approximation to a clinical setting we want to compared the same~     effectiveness of biofilm removal similarly on steel pins directly after explantation from~     patients treated with external fixators for at least 2 weeks. Sonication and SEM will be used~     for analysis.~      Preliminary Results Laser fluences exceeding 2.8J/cm2 caused a complete extinction of all~     living cells by a single laser impulse. Temperature rise within the implant is dependent on~     repetition frequency but overall negligible.~      The effectiveness of biofilm removal after cleansing with Octenidine soaked gauze and~     irradiation with the Er:YAG laser will be evaluated on cultivated and extracted pins.~      Conclusions We want to compare the effectiveness of the Er:YAG laser and Octenidine in the~     removal of biofilms from half-pins. We hypothesize that thee Er:YAG laser offers a secure,~     complete and non toxic removal of all kinds of pathogens from steel implants without damaging~     the implant or possible development of resistances. The precise non-contact removal of~     adjacent tissue could be an advantage over other disinfectants.~      Level of Evidence (II-a)~      Clinical Relevance:~      Having one more arrow in the quiver for disinfection of percutaneous implants or for septic~     revision surgery when osteosynthesis equipment or arthroplasties are meant to be left in~     place would be extremely desirable.~   "
26035|NCT03226171|"~     This study is conducted to assess the efficacy and safety of SK-1403 in Hemodialysis Patients~     with Secondary Hyperparathyroidism. In the first treatment period, the efficacy of SK-1403 is~     assessed after 18 weeks of treatment with SK-1403 individually dose-adjusted . Safety is also~     assessed during this period. Patients who completed the first treatment period proceed to the~     second treatment period and receive the treatment with SK-1403 for 34 weeks. Efficacy and~     safety of SK-1403 are also assessed during this period.~   "
26036|NCT03226158|"~     The majority of children and adolescents diagnosed with cancer will experience one or more~     episodes of fever or infection during their course of therapy. The most common~     microbiologically documented infection is bloodstream infection (BSI), which can be~     associated with severe sepsis or death. Current methods of diagnosis require a significant~     load of live bacteria in the blood making early detection difficult. Delayed diagnosis and~     delayed optimal therapy of BSIs are associated with increased morbidity and mortality.~      This study seeks to identify whether next generation sequencing (NGS) of pathogens can~     identify patients with impending bloodstream infection. This would enable preemptive targeted~     therapy to replace antibacterial prophylaxis which often leads ot high-density broad-spectrum~     antibiotic exposure and contributes to subsequent development of antibiotic resistance.~      PRIMARY OBJECTIVE:~        -  To estimate the sensitivity and specificity of next generation pathogen sequencing for~          prediction of bloodstream infection in children with cancer at high risk of infection.~   "
26037|NCT03226145|"~     Constipation is a common condition in which an individual suffers with hard stools which are~     infrequent and difficult to pass. It is poorly understood and treatment is often~     unsatisfactory. Many patients also experience pain whilst others do not but it is unclear why~     . It is believed that the pain arises from contractions in the colon, the lower part of the~     intestines. Some patients with constipation have weak colonic contraction but surprisingly~     some, particularly those with a lot of pain have strong contractions which are poorly~     coordinated. These patients all suffer from constipation but would are likely to need very~     different treatments. At present we cannot identify what type of abnormality of colonic~     contractions each individual patient suffers from and so are unable to give them the best~     treatment. This study will take advantage of two new techniques which have been recently~     developed. Magnetic Resonance Imaging (MRI) which will allow us to see the contractions of~     the colon in response to a dose of the laxative Moviprep which increases the flow of fluid~     into the proximal part of the colon and High Resolution Manometry (HRM) which measures the~     power and direction of the contraction in much more detail than ever before using a pressure~     sensing catheter placed into the bowel. Using these 2 techniques we will identify the pattern~     of contractions in 80 patients with constipation and 40 healthy controls. Participants will~     then enter into a controlled trial of either a drug which stimulates contractions or one~     which inhibits contraction. We anticipate that the pattern of contractions identified by the~     non-invasive MRI technique will predict which treatment will reduce their symptoms most as~     effectively as the more invasive HRM. If this is the case then our MRI test of colonic~     responsiveness could become widely used in routine clinical practice~   "
26038|NCT03226132|"~     Substance use disorders (SUDs) are a prevalent and impairing condition, particularly among~     trauma exposed individuals. The current proposal aims to address the critical need for~     targeted direct SUD prevention in this population by intervening on a novel, malleable risk~     factor for SUD common among trauma-exposed individuals: sleep disturbance. Sleep disturbance~     prospectively predicts the development of SUD and may confer risk for SUD by increasing~     stress reactivity, decreasing decision-making abilities, and ultimately promoting substance~     use to relieve negative affect, a core etiological factor in SUD. However, to our knowledge,~     no experimental studies have determined whether improving sleep leads to reductions in SUD~     risk. As such, the current study will use a randomized controlled trial design to test the~     effects of brief behavioral treatment for insomnia (BBTI) against a waitlist control among a~     sample of trauma-exposed young adults with poor sleep and risk for SUD (N = 60). We aim to~     determine the direct and indirect effects of condition (BBTI vs. waitlist control) on SUD~     symptoms, substance use-related problems, coping motives, and posttraumatic stress symptoms~     through improvements in sleep. Furthermore, we will test direct and indirect effects of~     condition on theoretically proposed mechanisms underlying the association between sleep~     disturbance and SUD risk (i.e., stress reactivity, cravings in response to stress).~   "
26039|NCT03226119|"~     This post-market study is intended to assess the performance of the HTLV Blot 2.4 in~     repository serum/plasma specimens with neurological disorders (n=100) or an HTLV known~     positive infection (n=50).~   "
26040|NCT03226106|"~     Although total knee arthroplasty is an effective intervention for decreasing knee pain and~     improving physical function, physical activity levels remain low up to a year after surgery.~     This study will use mobile-health technology to deliver an intervention designed to improve~     physical activity behavior for Veterans recovering from total knee arthroplasty. The study~     will assess the effectiveness of using behavior-change intervention as a supplement to~     conventional rehabilitation to improve physical activity. The intervention will be delivered~     using home-based tablet computers for Veterans to have remote interaction with the researcher~     and real-time physical activity feedback from a wrist-worn activity sensor.~   "
26106|NCT03225248|"~     This study is a multi-center, randomized, active-controlled, double-blind, non-inferiority,~     phase III clinical trial evaluating efficacy and safety of once-daily mosapride~     (UI05MSP015CT) in patients with functional dyspepsia.~   "
26044|NCT03226054|"~     Gastroesophageal Reflux Disease (GERD) can happen when stomach acid flows backward into~     your esophagus (tube from the mouth to the stomach), causing symptoms such as heartburn.~     Proton pump inhibitors (called PPIs) are a type of medication that reduce acid in the~     stomach and are used to reduce the discomfort from GERD. Treatment for GERD with PPIs is~     recommended to last up to eight weeks; however, many people take them for longer periods.~     Some people are placed on PPIs (particularly in the hospital) to prevent ulcers and~     inflammation of the stomach, but they do not need to be on the medication long term. Previous~     research studies have shown that there are some risks with taking PPIs for a long time. These~     risks include the inability of your body to absorb some vitamins and minerals, certain~     infections such as pneumonia or the digestive tract infection called C. diff, and possibly~     bone fractures. Therefore, it is desirable to stop taking a PPI when possible.~      The purpose of this study is to use a standard approach to help patients stop taking PPIs by~     adopting lifestyle habits known to reduce the symptoms of GERD while they slowly reduce their~     PPI dose. All medications used for this study are approved by the U.S. Food and Drug~     Administration (FDA). You are being asked to take part in this study because you have been~     taking a PPI for longer than the recommended time, and have either a diagnosis of GERD,~     gastritis, or an unclear indication for being on a PPI. About 100 patients from the Mount~     Carmel St. Ann's Family Medicine practice will participate in this research.~   "
26045|NCT03226041|"~     To investigate the accuracy and correlation of estimating arterial CO2 pressure（PaCO2） using~     a transcutaneous CO2 pressure（PTCCO2） monitor in patients undergoing retroperitoneoscopic~     renal or adrenal surgery.~   "
26046|NCT03226028|"~     The capacity of music to relieve pain has been used in many forms of medicines and has been~     proven to reduce anxiety, pain and need for analgesia in perioperative setting. However,~     music listening as an inexpensive and duplicable method has not been studied in the local~     context. The investigators hereby propose a prospective study to recruit women who undergo~     surgery to evaluate the effectiveness of music in pain relief and post-operative recovery in~     KKH; as well as the possibility of implementing music listening in perioperative setting.~      The patients will be offered to listen to one out of several pre-determined lists of music of~     different genres before, and after surgery. Data including pain score, Hospital Anxiety and~     Depression Scale (HADS) score, EuroQol-Five Dimensions questionnaire-using Three Levels~     (EQ-5D-3L), vital signs, analgesia usage and patient satisfaction will be collected in the~     perioperative period. The collected data shall also be assessed if they are affected by the~     presence of music, duration of music listening, and the genre chosen by the patients.~      The investigators believe that this study could help determine the clinical relevance of~     music for pain relief in local setting, which potentially could reduce patient pain and~     anxiety caused by surgery. This in turn could allow music listening to be adopted as a~     non-invasive pain relief intervention in local healthcare settings and further improve~     patient outcome with lower cost and greater convenience as well as safety.~   "
26047|NCT03226015|"~     PURPOSE: To report clinical and histochemical results of oral mucosa graft transplantation in~     eyes with limbal stem cell deficiency.~      DESIGN: Prospective observational study.~      METHODS: 32 eyes of 27 patients with limbal stem cell deficiency underwent direct oral mucosa~     graft transplantation with amniotic membrane transplantation with a mean follow-up of 19~     months. Clinical course of the disease including emergency surgeries, planned curative~     procedures, conjunctival inflammation, acute inpatient treatment and best corrected visual~     acuity were assessed at 3 months postoperatively and at last follow up visit. The unneeded~     parts of oral mucosa graft were analyzed immunohistochemically with staining for mesenchymal~     stem cell markers and pericytes (CD 90, CD 146, CD 166, CD 31, CD 68, protein gene product).~   "
26048|NCT03226002|"~     After Ethics committee approval investigators decided to enroll 40 patients ASA I-II, 18-60~     years of age undergoing maxillofascial, oral and double chin surgery to determine which~     nostril is more suitable for nasotracheal intubation with nasotracheal Airtraq. We primay~     aimed to compare the glottis visualization time, intubation time and total intubation times.~   "
26049|NCT03225989|"~     This Phase I/II trial evaluates LOAd703 in patients with cancer (pancreatic, biliary,~     colorectal or ovarian) together with their standard of care chemotherapy or using gemcitabine~     immune-conditioning. LOAd703 is administered by intratumoral image-guided injections. Maximum~     50 patients can be enrolled.~      LOAd703 is an immunostimulatory gene therapy using an selection replication competent~     adenovirus as a gene vehicle. The virus is derived from serotype 5 adenovirus with the fiber~     from serotype 35. It expresses the transgenes trimerized membrane-bound isoleucine zipper~     (TMZ) TMZ-CD40L and 41BBL under control of a cytomegalovirus (CMV) promoter.~   "
26050|NCT03225976|"~     Phototherapy is a therapeutic resource of increasing use in the last decade. The~     photobiomodulatory effects are commonly produced by means of low intensity lasers or LED~     emitting diodes, and can be used at different wavelengths. These light sources are divergent~     as to coherence, but produce equivalent tissue effects. The application of laser or LED light~     is able to induce biochemical changes in tissues, allowing for inhibitory or stimulating~     effects. These responses are associated to a cascade of cellular reactions, which favor the~     absorption of enzymes by cytochrome c oxidase, generating physiological responses that lead~     to decreased production of reactive oxygen species and increased synthesis of adenosine~     triphosphate (ATP). The application of this therapeutic resource brings ergogenic and~     protective benefits in muscular performance. The use of LED as a light source is promising~     because of its low cost, but there are no enough studies that support this use in athletes,~     with a focus on performance improvement. In addition to the deficiency of the sample, there~     is also no consensus regarding the use of different wavelengths for LED in the literature,~     thus opening gaps for the best protocol for the application of this technique. Therefore, a~     study that evaluates the use of LED in athletes, with different wavelengths, to improve~     performance is necessary. Hypothesis: It is hypothesized that the LED application is capable~     of improving athletes performance in terms of increased fatigue resistance, increased~     strength and power, increased muscle recruitment, and optimized oxygen demand. It is also~     expected that the results generated in this study can contribute to and increase the~     resources used by physiotherapists within the clinical-sports field, contributing to the~     post-training recovery, as well as the more effective physical performance in competitive~     activities.~   "
26051|NCT03225963|"~     Bevacizumab has become the standard of care of recurrent glioblastoma based on promising~     clinical trial results with with response rates up to 50% and progression-free survival up to~     9 months. In our study, we set to find the serum angiogenesis biomarkers of bevacizumab~     response.~   "
26052|NCT03225950|"~     This study evaluates the interaction between host immune cells and bacteria associated with~     periodontitis. It comprises biological material from donors with and without periodontal~     disease. Specifically, we collect a spit and blood sample to conduct in vitro stimulations~     and measurements of selected parameters related to periodontitis to clarify obscure areas in~     the immunologic pathogenesis of this disease.~   "
26053|NCT03225937|"~     This is a Phase II multi-center 2-sequential cohorts trial, designed to assess the objective~     response rate of two anti HER2 combination in advanced disease CRC patients harbouring an~     amplified HER2 tumor assessed according to HERACLES Diagnostic Criteria by FISH/SISH.~      Cohort A: monoclonal antibody trastuzumab, used in combination with the small molecule~     tyrosine kinase inhibitor lapatinib.~      Cohort B, monoclonal antibody pertuzumab, used in combination with the antibody drug~     conjugate trastuzumab-emtansine.~      Please note that cohort A accrual has been closed and endpoint already reached.~   "
26054|NCT03225924|"~     The primary objective of the phase Ib of the study is to determine the recommended phase 2~     dose (RP2D) for entospletinib (ENTO) in patients treated with R-CHOP.~      The primary objective of the phase II is to determine the complete metabolic response (CMR)~     rate by the Lugano classification 2014 (Deauville scale 1-3) at the end of treatment.~   "
26055|NCT03225911|"~     The focus of this project is to determine the immediate efficacy of a combined treatment~     (lateral wedge insole + simple knee sleeve) in individuals with knee osteoarthritis (OA) and~     the short term effect over 6 weeks. Secondly, to compare the effect of this combined~     treatment with each treatment on its own (lateral wedge insole, simple knee sleeve)~   "
26056|NCT03225898|"~     The American College of Sports Medicine (ACSM) recommends that resistance exercise performed~     at greater than 70% one repetition maximum (1 RM) is necessary to induce strength gains and~     muscular hypertrophy (ACSM, 2009). However, previous work has shown resistance exercise at~     high intensity increases the rate of injury. Blood flow restriction (BFR) exercise is a~     method that is used to compress the blood vessels to the exercising muscle in order to reduce~     blood flow to the limb with the use of low-intensity resistance. Researchers have suggested~     that resistance exercise at intensities as low as 20-30% 1-repetition maximum with BFR~     increases in muscle mass, muscular endurance, and gains in strength. However, the acute heart~     and blood vessel changes in response to BFR are not clear. Work by our laboratory (Tai et~     al., 2016) has demonstrated that immediately following acute resistance exercise at moderate~     intensity (75% 1 RM) without BFR, there are no changes in aortic and brachial systolic and~     diastolic blood pressure (BP), but there are increases in the pressure of the reflective wave~     (augmentation pressure). This suggests that the arterial wall is stiff, and may in turn~     result in thickening of the arterial wall. However, the data are limited and these responses~     may not be universally accepted. In addition, these studies used primarily lower-body~     resistance exercises (squat, leg extension, and leg flexion), and did not assess changes in~     heart and blood vessel function. Previous researchers have demonstrated that upper-body~     exercise induces higher BP and heart rate (HR) than lower-body exercise. However, the effects~     of upper- and lower-body resistance exercise with BFR on heart and blood vessel function are~     still unclear. Therefore, understanding the effects of upper- and lower-body resistance~     exercise with BFR on heart and blood vessel function using weight machines, specifically the~     chess press, latissimus dorsi pulldown, knee extension, and knee flexion may significant~     impact how the resistance training program is prescribed.~   "
26057|NCT03225885|"~     This study evaluates the effectiveness of prenatal counseling when verbal counseling is~     supplemented with a multi-media mobile application versus a written gestational age handout.~   "
26058|NCT03225872|"~     Osteosarcoma is very rare cancer of the bone. The investigator started the BOOST registry and~     biobank to make sure every patient has the opportunity to participate in research.~   "
26059|NCT03225859|"~     Veterans who complete trauma-focused therapies (TFTs) report improvements in posttraumatic~     stress disorder symptoms, quality of life, and social and role functioning. However, many~     also report uncertainty regarding their ability to maintain and build upon progress made~     during TFTs following the end of treatment. Veterans who recently completed a course of TFT~     believe the likelihood of their ongoing success would be bolstered by mental health services~     that support additional practice and reinforcement of skills learned in TFT. Currently no~     evidence-based approach for post-TFT care exists; however, Veterans' reported treatment needs~     are well-suited to a therapist-assisted self-management approach. The objective of this~     project is to complete Stage 1 (intervention refinement and piloting) of the Stage Model of~     Treatment Development for a post-TFT therapist-assisted self-management program designed to~     help Veterans maintain or build upon gains made in TFT, increase self-efficacy for managing~     their PTSD symptoms, and enhance community engagement. The aims of the project are to: 1)~     Refine a self-management treatment protocol through eliciting feedback from experienced TFT~     providers on a draft of the self-management program, 2) Conduct a pilot open trial to assess~     the acceptability and feasibility of the self-management program, and 3) Explore the effects~     of the program on Veterans' confidence in managing their PTSD and Veterans' functioning,~     quality of life, community engagement, and mental health symptoms.~   "
26060|NCT03225846|"~     PRECISION-HD2 is a Phase 1b/2a multicenter, randomized, double-blind, placebo-controlled~     study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD)~     of single and multiple doses of WVE-120102 in adult patients with early manifest Huntington's~     disease (HD) who carry a targeted single nucleotide polymorphism (SNP) rs362331 (SNP2).~   "
26061|NCT03225833|"~     PRECISION-HD1 is a Phase 1b/2a multicenter, randomized, double-blind, placebo-controlled~     study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD)~     of single and multiple doses of WVE-120101 in adult patients with early manifest Huntington's~     disease (HD) who carry a targeted single nucleotide polymorphism (SNP) rs362307 (SNP1).~   "
26062|NCT03225820|"~     (a) To explore the feasibility and utility of implementing broad preemptive pharmacogenomic~     result delivery in the inpatient setting across multiple institutions specifically with the~     goal of incorporating minority-specific pharmacogenomic information; (b) To determine whether~     clinical outcomes for the drug warfarin are improved in African Americans through the~     availability of pharmacogenomics-based dosing guidance at the point-of-care.~   "
26063|NCT03225807|"~     This is a quality improvement study with the purpose of observing and measuring the effects~     of implementation of a proven standardized lung protective ventilation protocol in the new~     electronic medical record system iCentra across all Intermountain Healthcare hospitals.~     Approximately 14,000 records will be accessed for this study from a database of mechanically~     ventilated patients established for quality improvement purposes.~      The investigators hypothesize that implementation of a standardized computerized lung~     protective ventilation protocol across all Intermountain Healthcare hospitals will be~     feasible, will decrease initial tidal volumes to the target 6 ml/kg PBW, and will improve~     outcomes.~      The objectives of this study are to:~        -  Determine if the implementation of lung protective ventilation (with a 6 ml/kg PBW tidal~          volume ventilation protocol on initiation of mechanical ventilation) improves outcomes~          in patients with acute respiratory failure requiring mechanical ventilation~        -  Determine if the implementation of lung protective ventilation (with a 6 ml/kg PBW tidal~          volume ventilation protocol on initiation of mechanical ventilation) improves outcomes~          in the sub-group of patients with the acute respiratory distress syndrome (ARDS)~        -  Measure compliance with the implementation of a computerized lung protective ventilation~          protocol at 12 Intermountain Healthcare hospitals~   "
26064|NCT03225794|"~     About three quarters of the viral agents that have emerged recently in humans are considered~     to originate from other animals. These viruses have often evolved and spread into the human~     population through various mechanisms after the initial contact that resulted in interspecies~     transmission. However, knowledge of the initial stages of the emergence of viruses and~     associated diseases is still limited in many cases. Microbiological monitoring in populations~     at risk of transmission would provide insights into the initiation and early stages of the~     emergence process.~      Nonhuman primates (NHPs) share many genetic, physiological, and microbiological features with~     humans, and are potential sources of many infectious agents. This has been demonstrated for~     several simian retroviruses. HIV-1 and 2 are believed to have originated from chimpanzee and~     mangabey viruses, respectively, found in Central and West Africa. The current distribution of~     the various molecular subtypes of the HTLV-1 oncogenic retrovirus in Africa is mainly the~     result of numerous instances of interspecies transmission of STLV-1from NHP species in the~     distant past.~      Foamy viruses belong to the Retrovidae family and the Spumavirus genus. They are complex~     exogenous retroviruses and are very common in many animal species, including primates, cats,~     cattle, and horses, in which they cause persistent infections.~      The first aim of the work is to study the epidemiological and molecular aspects of the~     transmission of foamy viruses from monkeys to humans in populations at risk, such as the~     inhabitants (especially hunters) in the villages of the dense forests of southern Cameroon.~     It is an area in which NHPs are still very common, with a great diversity of species. The~     investigators have already shown that the prevalence of foamy viruses is very high in these~     monkeys and great apes (gorillas and chimpanzees). Contact between these monkeys and the~     villagers is very frequent, mainly during hunting. The second aim of the project is to study~     the clinical and biological features of infected people and investigate intrafamilial~     transmission from infected index cases.~   "
26065|NCT03225781|"~     Electrochemotherapy is a type of electroporation that allows the delivery of drugs to the~     cells through the local creation of pores in the cell membrane. The electric pulses can be~     applied directly to the neoplastic cells, allowing for the local concentration of a possible~     chemotherapeutic agent administered through the bloodstream. This technique does not use heat~     nor other thermal energies and it is performed using special needles/electrodes linked to a~     generator (porator).~      In this study this technique will be applied on unresectable pancreatic cancer, already~     submitted to neoadjuvant treatment and still unresectable, through laparotomy. Bleomycin will~     be the chemotherapeutic agent.~   "
26066|NCT03225768|"~     Abstract~      Participation is an ultimate rehabilitation goal that is important to patients, providers,~     and insurance payers. Since the International Classification of Functioning, Disability, and~     Health (ICF) published, a growing body of literature has emerged to investigate participation~     among people with functional limitations in diverse service settings. However, no research to~     date has developed an effective intervention that show promise to successfully enhance~     participation among individuals with cognitive impairments after stroke and traumatic brain~     injury (TBI).~      The purpose of this study is to examine the feasibility of applying an intervention strategy~     that has shown promise to increase functional independence of rehabilitation patients with~     cognitive impairments, the guided training, to enhance participation performance among~     individuals with cognitive impairments after stroke and TBI in the outpatient rehabilitation~     settings in Taiwan.~      A mixed-methods (quantitative and qualitative) design, including a repeated measures design,~     will be used in this feasibility study. Adults (n=45-60) who had a first-time stroke or TBI~     within the past six months and have cognitive impairments will be recruited from the great~     Taipei area. These participants will receive 2 to 3 intervention sessions per week for 10 to~     15 sessions. Standardized assessments, including the Participation Measure--3 Domains, 4~     Dimensions (PM-3D4D), the Activity Measure for Post-Acute Care (AM-PAC), and the Wisconsin~     Card Sorting Task (WCST), will be used to assess participation and other functional outcomes~     at baseline, post-intervention, and 3-month and 6-month follow-up. The feasibility~     indicators, such as recruitment rates and intervention attendance and adherence, will be~     evaluated by questionnaires, field notes, and qualitative interviews after the interventions~     are completed.~      Quantitative data will be analyzed descriptively; while data obtained from the outcome~     measures will be examined using Wilcoxon signed rank test and effect size (r) to compare the~     differences between the pre- and post-intervention scores. Qualitative data will be analyzed~     using thematic analysis method.~   "
26067|NCT03225755|"~     The growth hormone (GH )axis has important influences on adipose tissue. GH may have a novel~     effect to reduce macrophage yet increase adipocyte inflammation in adipose tissue along with~     reducing adipose tissue mass. In order to examine the effect of GH on adipose tissue~     inflammation, this study will examine adipose tissue and serum inflammation in patients with~     GH deficiency before and after GH therapy. The investigators will also obtain serum samples~     before and after treatment for adipokines, inflammatory markers and examine macrophages in~     circulation with regard to their inflammatory state. The investigators will also obtain~     adipose tissue biopsies from healthy subjects matched to the GHD subjects. Adipose tissue~     specimens will be analyzed for adipose tissue morphology, adipocyte size, adipokine gene~     expression, and adipose tissue macrophage number.~   "
26068|NCT03225742|"~     After incontinence surgery, the patients randomly will be divided two groups. In group A~     postoperative urinary catheterization time will be applied one day, In group B~     catheterization will be applied two days. After removal of urinary catheter, residual volume~     will be measured and voiding function will be controlled. In postoperative period; third,~     sixth month and one year after surgery stress test will be applied to control success of~     surgery~   "
26069|NCT03225729|"~     This study evaluates the performance of new technology CRYOTHERAPY MAINS ET DECOLLETE~     against a classic cryotherapy Nitrogen Liquid  to treat solar lentigines.~      The hands and the neckline will be randomised, either left or right side and treated by two~     cryotherapy devices:~        1. CRYOTHERAPY MAINS ET DECOLLETE is the device under evaluation.~        2. Liquid nitrogen is a comparator device.~   "
26070|NCT03225716|"~     This research study is studying Ulocuplumab combined with ibrutinib as a possible treatment~     for symptomatic Waldenstrom's Macroglobulinemia (WM).~   "
26071|NCT03225703|"~     Osteoarthritis (OA) and osteoporosis (OP) affect large numbers of the population. Around 8~     million people in the UK are affected by OA and over 300,000 people present with fragility~     fractures in the UK each year. High impact exercise has been shown to improve markers of bone~     health but the effect of this exercise on the cartilage is less well understood. A six month,~     one leg, exercise program based on hopping will be carried out by a group of post-menopausal~     women. Post-menopausal women are particularly at risk from OP and the research should give~     information on the feasibility of this type of exercise program in this age group and the~     effect on cartilage. Participants will be aged between 55 and 70 (at least five years post~     menopause) with no conditions that would limit their ability to complete the exercise~     program.~      To assess changes in participants' cartilage and bone properties they will be asked to attend~     several meetings at Loughborough University. Before and after the exercise program~     participants will have bone density scans and MRI scans of the knee joint. A subset (n=4)~     will undergo high resolution bone scans that can demonstrate changes in bone structure. The~     intervention is a home based exercise programme lasting approximately 10 minutes per day.~     Initially this will be individualised to each participant with the end goal being daily~     exercise sessions. The programme will last for six months with supervised sessions offered~     throughout the trial. Using an intervention affecting just one leg will allow the research~     team to use the other leg as a control.~      The research team hypothesise that in a population of post-menopausal women, a six month,~     unilateral exercise intervention will improve bone mineral density at the proximal femur with~     no negative effects on articular cartilage.~   "
26072|NCT03225690|"~     American Society of Anaesthesiologist physical status (ASA) I-III 105 patients who undergoing~     major abdominal surgery in obstetric and gynaecology clinic were recruited to this study.~     Patients were randomized into the 3 groups. Lumbar epidural catheter will be inserted to the~     all patients. After than anaesthesia induction will provide with 2 mg/kg propofol and 0.6~     mg/kg rocuronium. Desflurane and azot protoxit (N2O)-O2 will use for anaesthesia maintenance.~     During surgical operation, 0.3 microgram/kg/h remifentanil infusion will continuous till the~     end of surgery. In group I, 2 ml serum physiologic (0.9 NaCL)will apply from epidural~     catheter before surgical incision. In group II, 1 mg morphine will apply from epidural~     catheter before surgical incision. In group III, 1 mg morphine will apply from epidural~     catheter at the time point of peritoneum is closed. Epidural patient controlled analgesia~     will provide with bupivacaine for postoperative analgesia. Postoperative pain will be~     assessed with numerical pain scale. Postoperative analgesic requirement will be calculated.~     Hyperalgesia will detect with algometer and von Frey ligaments.~   "
26073|NCT03225677|"~     To determine the rate and mechanisms of skeletal muscle protein synthesis and breakdown in~     cirrhotic patients by using multiple tracers and single muscle biopsies.~   "
26074|NCT03225664|"~     There are 2 parts in this study.~      The goal of Part 1 of this clinical research study is to find the highest tolerable dose of~     trametinib when given with pembrolizumab to patients with refractory (has come back after~     treatment) non-small cell lung cancer (NSCLC).~      The goal of Part 2 of this clinical research study is to learn if pembrolizumab given alone~     or in combination with trametinib at the dose that was found in Part 1 of the study can help~     to control NSCLC in patients who previously received chemotherapy or immunotherapy.~      The safety of the study drugs will be studied in both parts.~      This is an investigational study. Pembrolizumab is FDA approved and commercially available~     for treatment of many types of cancers, including NSCLC. Trametinib is FDA approved and~     commercially for the treatment of melanoma. It is considered investigational to use the study~     drug(s) to treat the type of NSCLC you have.~      Up to 217 participants will be enrolled in this multicenter study. Up to 150 will take part~     at MD Anderson.~   "
26075|NCT03225651|"~     The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow~     mononuclear stem cells combined with Psychological Therapy and Rehabilitation for Autism~     children~   "
26076|NCT03225638|"~     The aim of this study is to evaluate the intramuscular nominal thigh injection performance~     and the low threshold strength thigh injection (by evaluating 2 low threshold : upper limit~     and lower limit). All participants will receive an intramuscular nominal thigh injection, and~     half of the participants will receive an intramuscular low threshold (upper limit) strength~     thigh injection, while the other half will receive an intramuscular low threshold (lower~     limit) strength thigh injection.~   "
26077|NCT03225625|"~     The SciExVR study will evaluate the potential benefit of autologous bone marrow derived stem~     cells (BMSC) in the treatment of spinal cord injury with evidence of impaired motor or~     sensory function. The treatment consists of bilateral paraspinal injections of the BMSC at~     the level of the injury as well as superior and inferior to that spinal segment followed by~     an intravenous injection and intranasal placement. Patients undergoing BMSC treatment may~     also be assigned to use of exoskeletal movement (or equivalent) or virtual reality~     visualization (or equivalent) to augment upper motor neuron firing and/or receptivity of the~     sensory neurons. http://mdstemcells.com/sciexvr/~   "
26078|NCT03225612|"~     The purpose of this study is to assess the safety and performance of the Trialign System for~     the treatment of symptomatic chronic functional tricuspid regurgitation (FTR) in patients~     with a minimum of moderate tricuspid regurgitation.~      The procedure will be performed with the PTVAS device using a non-surgical percutaneous~     approach to tricuspid valve repair in patients who have FTR with a minimum of moderate~     tricuspid regurgitation.~   "
26079|NCT03225599|"~     Patients who have concussions exhibit an array of symptoms, also known as post-concussive~     symptoms, including headaches, feeling slowed down or foggy and difficulty with~     concentration. This study aims to determine if cranial osteopathy can provide additional or~     expedited symptom relief when accompanying current conventional treatments. The patients will~     be identified through routine clinical contact. If patients are found to be eligible and~     agree to participate, they receive a single session of cranial osteopathy in addition to~     their usual care through the concussion program.~   "
26080|NCT03225586|"~     To examine the impact of health determinants at the individual (e.g. health related~     behaviors) and societal level (e.g. environmental factors, health related policy, quality of~     health systems) on health outcomes (e.g. death, non-communicable disease development) across~     a range of socioeconomic and health resource settings. Additional components of this study~     will examine genetic factors for non-communicable diseases. This will be examined both~     through a cross sectional component, and prospectively (cohort component).~   "
26081|NCT03225573|"~     a cross-sectional study to estimate the prevalence of a second mesiobuccal canal of maxillary~     first and second molars in Egyptian population using cone beam computed tomography through~     retrospective data analysis~   "
26082|NCT03225560|"~     This is a randomized controlled trial designed to assess the efficacy of a novel smartphone~     application as an automated reminder tool in improving the quality of bowel preparation for~     patients undergoing outpatient colonoscopies. The investigators will be comparing the~     smartphone application to traditional instructions for bowel preparation. The quality of~     bowel preparation will be assessed using the Ottawa and Aronchick bowel preparation scales.~   "
26083|NCT03225547|"~     This is a Phase II study of pembrolizumab plus mifepristone in advanced breast cancer~     patients. The study will include a safety lead in of ten patients. Patients who are deemed~     eligible and have signed informed consent will be treated with pembrolizumab at a fixed dose~     of 200 mg intravenously on day 1 of each 21 day cycle for each dose level. Mifepristone 300mg~     PO be administered daily starting the week prior to pembrolizumab.~      Once the safety of the combination is confirmed (study will be paused at least 6 weeks after~     first 10 patients are enrolled for safety evaluation), dose expansion cohorts will be~     performed in parallel for two cohorts: cohort 1 in triple-negative breast cancer and cohort 2~     in hormone receptor positive breast cancer.~   "
26107|NCT03225235|"~     The main purpose of study is to evaluate hypofractionated stereotactic radiotherapy (SBRT)~     using CyberKnife for Patients with low and intermediate risk of progression prostate cancer.~   "
26084|NCT03225534|"~     This proposal relates to the testing of several specific hypotheses in a subset of 500~     participants in the Canadian Healthy Infant Longitudinal Development (CHILD) Study. These 500~     now have complete data from the time of recruitment (in pregnancy) to age 1 year. The primary~     purpose of this proposal is to identify risk factors for early allergic outcomes and~     biomarkers that may predict future disease. These 500 infants will provide critical~     preliminary data, not only related to early outcomes, but also to inform analytical plans for~     the full CHILD cohort.~   "
26085|NCT03225521|"~     The aim of this research is to evaluate the efficacy of contextually tailored activity~     suggestions and activity planning for increasing physical activity among sedentary adults.~   "
26086|NCT03225508|"~     This study evaluates the movement of the diaphragm (which is the main muscle used for~     breathing). It will compare two ultrasound modalities: linear ultrasound versus curvilinear~     ultrasound, at measuring diaphragm motion. The proposed measurement method with linear~     ultrasound is novel, and will be compared against the established method with curvilinear~     ultrasound. The investigators hypothesize that the novel method will have several potential~     advantages, including: it may be easier to learn, quicker to perform, and have a lower~     failure rate.~   "
26087|NCT03225495|"~     The main target of the study is to compare ultra-narrow diameter implants (2.75 mm) without~     bone regeneration versus standard diameter implants (4.3 mm) in combination with bone~     regeneration. To do so, patients with missing upper central incisors, canines, first or~     second premolars with alveolar ridges of 6 - 8 mm of thickness will be restored with dental~     implants. Cone beam computed tomographic examination and clinical values will be registered~     before and after the surgical procedure at 6 and 12 months.~   "
26088|NCT03225482|"~     The number of older Veterans with Mild Cognitive Impairment (MCI) seeking care within the~     Veterans Affairs (VA) health care system is increasing and is expected to increase more~     rapidly as Vietnam era Veterans age. The cognitive effects of MCI and subsequent~     neurodegenerative disorders can adversely affect a Veteran's ability to function~     independently and failure to provide appropriate intervention can result in an increased need~     for healthcare services and VA benefits in the future. The VA currently spends over $19,000~     annually per patient to care for Veterans with dementia (Zhu et al., 2009), and delaying the~     onset of dementia even by one to two years will result in substantial financial savings to~     the VA and quality of life gains for the Veteran. Since present pharmacological interventions~     have demonstrated limited efficacy, alternative treatments are needed. Therefore, an~     evidence-based cognitive training intervention that optimally addresses the needs of older~     Veterans with MCI is of critical importance to the VA patient care mission.~   "
26089|NCT03225469|"~     Enhanced instructions such as re-education by telephone or short message which increase the~     patient adherence eventually improve the quality of bowel preparation significantly. However,~     the effect of family assistance which plays an essential role on compliance of patient with~     treatment on bowel preparation is unknown. The investigators hypothesized that reinforced~     education giving family members of outpatients will enhance family support to patients for~     colonoscopy, and consequently improve the quality of bowel preparation.~      Therefore, the investigators designed protocols to reinforce family member education by~     verbal (face to face or telephone) and written methods. The aim of this study is to evaluate~     the effect of reinforced family member education on patient compliance and the quality of~     bowel preparation for colonoscopy. In addition，the rate of side effects happening, the~     subjective feelings of bowel preparation, the outcomes of colonoscopy ,and the independent~     risk factors will be also assessed.~   "
26090|NCT03225456|"~     In this protocol, the investigators propose a randomised controlled trial to explore the~     effects of intra-nasal oxytocin administration on appetite regulation. The investigators will~     run a cross-over design with 60 healthy adult men.~   "
26091|NCT03225443|"~     Locally advanced cervical cancer (LACC) refers to the clinically cervical visible lesion with~     a diameter of > 4 cm, which has been considered as a high risk of early cervical cancer for a~     long time. Because of local bulk lesion of LACC, the risk of radical hysterectomy is pretty~     high and the radical effect commonly does not meet the satisfactory. Therefore, 1-3 course of~     neoadjuvant chemotherapy (NACT) were carried out before operation. However, nearly 20% of~     patients are not sensitive to NACT. Therefore NACT did not bring any benefits to radical~     surgery even to some extent delayed the treatment.~      Traditional radiotherapy is also commonly used in the treatment of LACC, however ovarian~     function would be permanently destroyed especially for young patients, additionally~     radioactive complications to adjacent organs of cervical such as vagina, bladder and rectal~     also commonly happened, moreover sexual dysfunction after radiotherapy significantly affect~     the life quality of young patients.~      Particle radiotherapy developed recently, has the advantages of short course of treatment and~     mild side effects, due to its special working mechanism, Bragg effect. So the amount of~     radiation in the tumor tissue is very extremely high, and in the adjacent tissue is quiet~     low, therefore the organs at risk were protected by avoiding unnecessary damage.~      Based on these, we proposed the application of particle radiotherapy in LACC pre-operation,~     and comprehensively evaluated recent curative effect, complications and long-term follow-up~     between particle radiotherapy and NACT. Furthermore, the clinical significance and long-term~     application prospects about particle therapy were objectively assessed.~   "
26108|NCT03225222|"~     To evaluate the diagnostic performance and cost-effectiveness of the MRI-driven diagnostic~     pathway of prostate cancer, with upfront individual multivariate risk stratification.~   "
26130|NCT03224936|"~     While Drug Induced Sleep Endoscopy (DISE) in patients with obstructive sleep apnea syndrome~     (OSAS) apnea and hypopnea occur. Because of the induced phases of apnea in a controlled~     setting it is possible to evaluate the related pathophysiology of apnea. We plan to correlate~     the Patient State Index (PSI) and other physiologic parameters with phases of apnea and~     hypopnea.~   "
26175|NCT03224351|"~     This is a Phase 2, randomized, double-blind, placebo- and tezacaftor/ivacaftor~     (TEZ/IVA)-controlled, parallel-group, 3-part, multicenter study designed to evaluate the~     safety and efficacy of VX-659 in triple combination (TC) with TEZ and IVA in subjects with~     cystic fibrosis (CF) who are homozygous for the F508del mutation of the CF transmembrane~     conductance regulator (CFTR) gene (F/F genotype), or who are heterozygous for the F508del~     mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ, IVA, or~     TEZ/IVA (F/MF genotypes).~   "
26092|NCT03225430|"~     It is a randomized controlled trial to compare two behavioural treatments, namely CBIT and~     CoPs. This study would be the first head-to-head randomized trial between two established~     treatments rather than supportive counseling or wait-list control. Thirty-six adults and 36~     children with TS/TD will be recruited into each of the two (CBIT, CoPs) modalities requiring~     a total recruitment of 72 adults and 72 children over 5 years, which permits, even for a~     small-medium effect size, a robust power calculation. Motor performance measures will give~     concurrent validity to changes pre-post in TS/TD motor processes. Recruitment of both males~     and females will permit sex comparisons. The participants meeting inclusion/exclusion~     criteria will be assessed at pre-post 1 month and 6 months following treatment on~     standardized tic scales and global assessment of functioning. Participants will be treated~     individually on a weekly basis by therapists with an allegiance to each modality and outcome~     assessed by masked evaluation. The treatments are manualized and will last 10 weeks with 4~     weeks of home practice at post-treatment with 6-month follow-up assessment on all outcome~     measures, plus motor performance measures post-treatment. All treatment sessions will be~     audio-recorded and assessed with implementation of treatment integrity procedures scales. The~     hypotheses are that: (1) the CoPs group will show superiority in clinically significant~     improvement on standard tic scale score, global functioning and quality of life than the CBIT~     group; and (2) changes in recognized parameters on selected motor tests scored according to~     published norms will change towards normalization post CoPs but not post CBIT. The outcome~     data from the two treatments will be analyzed by a mixed linear model adaptation of repeated~     measures MANOVA and daily diary measures will allow for an additive time series design over~     the 10 weeks treatment session. This design will allow computation of the size of treatment~     effects at different stages of therapy. The study results will impact on the treatment of~     choice and access to treatment for tic disorders and on the conceptualization of tic~     disorders.~   "
26093|NCT03225417|"~     Allogeneic hematopoietic stem cell transplantation (HTC) is the only curative option for many~     patients with hematologic malignancies but >50% of this patients will develop extensive~     chronic graft-versus-host disease (cGVHD), which remains the most important complication~     after HTC.~      Classically, the most effective strategies to prevent GVHD have not improved survival;~     therefore, the new strategies are being sought.~      This study is designed in two phases: the main objective for phase I study is the more~     suitable dose for ixazomib search. Phase II study is designed to evaluate the efficacy of~     ixazomib at the doses stablished in phase I.~   "
26094|NCT03225404|"~     The concept of epicondylitis refers to the manifestation of pain ni the area of insertation~     of the epicondile muscles, and that it is accompained by limitation funcional.A tendinopathy~     is characterized as a process of degenaration, with fibroblast proliferation and~     disorganization of the fibers of collagen. This tendon pathology especially affects the~     epicondyle extensors and especially the first and second radial and short extensor carpal.~   "
26095|NCT03225391|"~     Sleep deprivation produces changes including alteration of mood, irritability, fatigue, less~     focus and disorientation, also perceptive distortions, visual hallucinations and considering~     tasks harder and less pleasant. In resident phsycians, these alterations have been shown to~     affect their work performance. Naps have proved to improve arousal and attention, alertness~     and performance. Those longer than 90 minutes promote a learning process similar to that~     ocurring in REM sleep. Therefore a nap schedule could improve the decision making of~     residents during their working hours.~   "
26096|NCT03225378|"~     The passive leg raising (PLR) test is a reversible preload challenge of around 300 mL of~     blood that can be repeated as frequently as required without infusing a drop of fluid. Two~     recent meta-analyses of many studies have confirmed the reliability of the PLR test to~     predict fluid responsiveness in patients with acute circulatory failure. Nevertheless, the~     effects of the PLR must be assessed by the direct measurement of cardiac output since changes~     in arterial pressure do not allow the assessment of the PLR hemodynamic effects with~     reliability. Moreover, cardiac output must be measured continuously and in real time.~      In clinical practice, cardiac output measurement can be difficult for different reasons such~     as the unavailability of the echocardiography machine, or the absence of any continuous~     cardiac output monitoring technique at the time of acute circulatory failure occurrence.~      Recently, it was shown that the decrease in pulse pressure variation (PPV) induced by the~     mini-fluid challenge (100 mL of colloid solution infused in 1 min) was able to predict fluid~     responsiveness with reliability in patients ventilated with low tidal volume (<8 mL/kg of~     ideal body weight).~      Therefore, the investigators hypothesize that the changes in PPV induced by PLR test could be~     able to predict fluid responsiveness with reliability in mechanically ventilated patients~     with acute circulatory failure.~   "
26097|NCT03225365|"~     This is an open bi-centric prospective non-randomized study in patients with metastatic~     melanoma treated with a first line treatment of Nivolumab +/- Ipilimumab. The aim of the~     study is to characterize the immune cells modulations under anti-PD-1 +/- anti-CTLA4 and~     identify the differences between responder and non-responder patients.~   "
26098|NCT03225352|"~     The aim of this study is to assess disintegration of the new Aspirin disintegrating tablets~   "
26099|NCT03225339|"~     Diabetes is one of the greatest challenges faced by healthcare services worldwide. It is~     associated with serious complications such as heart attacks, stroke, and peripheral artery~     disease as well as kidney disease, eye disease, and nerve dysfunction. Data from weight loss~     with bariatric surgery suggest that with the appropriate intervention, it should be possible~     to reverse diabetes and that the earlier the intervention occurs, the greater the chances of~     placing diabetes into remission. There is now a need to translate this knowledge into the~     medical care of younger patients with early diabetes who are overweight/obese. The aim of~     this study is to see if younger adult patients with overweight/obesity and type 2 diabetes~     who are participants in a programme incorporating a low energy diet and physical activity~     (lifestyle) will lower their weight, cardiovascular risk and improve their glycaemic control~     as compared to the usual care.~   "
26100|NCT03225326|"~     The purpose of this study was to investigate and compare pulpal anesthesia and cardiovascular~     parameters obtained with 0.6 ml of 4% articaine with epinephrine (1:100.000) for anterior and~     middle superior alveolar nerve (AMSA) block performed by standard and computer-controlled~     delivery for maxillary teeth extraction.~   "
26101|NCT03225313|"~     Prospective randomized double blinded controlled clinical trial will be done with a total~     number of 75 patients will be divided into 3 groups. To compare between Ultra-sound guided~     rectus sheath block VS Field block infiltration in providing a good analgesia for patients~     undergoing midline hernia repair to detect which one is superior.~   "
26102|NCT03225300|"~     Simultaneous integrated boost (SIB), a field-in-field escalation technique, has been~     introduced to deliver higher radiation dose to the certain part of target with the same~     fractionation scheme. The aim of this study was to investigate the value of chemoradiation~     (CCRT) using SIB in glioblastoma and the correlation with surgical extent.~   "
26109|NCT03225209|"~     Type 2 diabetes (DM2) is a chronic disease affecting 29 million Americans and a leading cause~     of blindness, kidney failure, and limb loss (Engelgau et al 2004). Roux-en-Y gastric bypass~     (RYGB) is the only intervention that leads to durable DM2 remission ~ 80% of the time~     (Mingrone et al 2012). Yet, it's broad application is limited by cost, invasiveness, and~     clinical inertia. Medically reproducing RYGB would extend the benefit of disease remission to~     the vast majority of DM2 patients using a cheaper, less invasive and more palatable treatment~     approach. Although all of the mechanisms mediating DM2 remission are not known, it is widely~     accepted that RYGB induces caloric restriction and enhances meal-stimulated release of a~     gut-peptide called glucagon-like-peptide-1 (GLP-1) both of which improve glycemic control in~     type 2 diabetes (Dar et al 2012; Jackness 2013). Caloric restriction can be achieved using~     OPTIFAST which is a commercially available medical weight loss program that has demonstrated~     the ability to decrease weight and improve glycemic control (Kirschner et al; 1998). Enhanced~     meal-stimulated GLP-1 release can be achieved using Liraglutide an FDA-approved once daily~     GLP-1 analogue that improves glycemic control and induces weight loss.~      The investigators hypothesize that adding OPTIFAST (caloric restriction) in suboptimally~     controlled DM2 patients on Liraglutide (enhanced meal stimulated GLP-1 release), Metformin~     and Lantus insulin will medically reproduce RYGB and lead to DM2 remission, weight loss,~     decreased medication intensity and improved health related quality of life.~   "
26110|NCT03225196|"~     Background:~      Extracellular RNAs (exRNAs) send genetic data from cell to cell. This is how they affect the~     way cells communicate with each other. There are many types of exRNA, and they each serve~     different roles. But they have also been linked to some diseases. Researchers want to measure~     exRNAs to see how they relate to certain traits over time. They will use blood samples that~     were taken as part of the Framingham Heart Study (FHS).~      Objectives:~      To identify cross-sectional associations of exRNAs with age, sex, and cardiometabolic risk~     factors.~      Eligibility:~      People ages 30-70 who had blood taken as part of the FHS Third Generation cohort.~      Design:~      Researchers will study samples that have already been collected in the FHS. There will be no~     active participant contact for this project, only use of data that are collected as part of~     planned follow up from other studies.~      As part of the FHS, participants gave blood samples. They gave permission for the blood to be~     used for research.~      The exRNAs from the blood samples will be studied to see how they relate to certain traits.~     These include age, sex, and body mass index.~      The exRNAs will also be studied for their usefulness as biomarkers of risk for subclinical~     atherosclerotic cardiovascular disease.~      No study participants will be contacted for this study....~   "
26111|NCT03225183|"~     Background:~      The Framingham Heart Study (FHS) was initiated by the U.S Public Health Service in 1948 and~     turned over to the newly established National Heart Institute in 1951. The FHS is now jointly~     led by the National Heart, Lung, and Blood Institute and Boston University. The FHS currently~     studies risk factors, and the genetics of heart and blood vessel disease, and other health~     conditions in three generations of study participants. Scientists want to use the data~     collected from this study to do more research. They want to use a technique that determines~     the sequence of ribonucleic acid (RNA) molecules.~      Objective:~      To study genes related to certain diseases and health conditions. These include heart and~     blood vessel diseases, lung and blood diseases, stroke, memory loss, and cancer.~      Eligibility:~      People in the FHS Third Generation cohort who already attended exam 2.~      Design:~      Researchers will study samples that have already been collected in the FHS. There will be no~     active examination or burden to participants. During FHS visits, participants gave blood~     samples. They gave permission for the blood to be used for genetic research. RNA will be~     generated from the samples. They will be given a new ID separate from any personal data. They~     will be stored in a secure FHS lab. The samples will be analyzed. Only certified researchers~     can access them.~      No study participants will be contacted in relation to this project.~   "
26112|NCT03225170|"~     Background:~      Some women with breast cancer and ovarian cancer are genetically predisposed to them. This is~     called hereditary breast and ovarian cancer (HBOC). The women have to make hard choices about~     tests and treatment. Researchers want to study the best way to guide them. A kind of writing~     exercise might help if it is done before genetic counseling. It is called a self-affirmation~     (SA) exercise. It may lead to better communication in the counseling and better behavioral~     outcomes.~      Objective:~      To test if an SA exercise done with HBOC genetic counseling could improve client~     communication and behavior.~      Eligibility:~      Adults ages 18-90 with an appointment at the HBOC clinic at St. Luke s Health System~      Adults ages 18-90 who are genetic counselors with breast and ovarian cancer clients~      Design:~      Appointment participants will be screened by phone.~      They will arrive 15 minutes early to their appointment.~      They will do a 10- to 15-minute survey and writing exercise. This includes questions about:~      If they have cancer~      If they have had or were offered genetic counseling~      Things that are important to them~      After the appointment, they will take a 10- to 15-minute follow-up survey. It can be in the~     office or online. It includes questions about how they felt about the writing exercise and~     their counseling.~      Counselor participants will take a 2- to 5-minute survey after sessions with clients in the~     study. This includes questions about how the client was in the session. They will take a 10-~     to 15-minute survey at the end of the study. It will be about their opinions of the writing~     exercise.~   "
26120|NCT03225066|"~     This study aims to assess efficacy and safety of Sculptra in the treatment of skin flaccidity~     in selected areas - arms, anteromedial region, and gluteal regions. To assess the efficacy of~     Sculptra®, via adapted Global Aesthetic Improvement Scale -GAIS- score determined by blind~     evaluator, in the treatment of skin flaccidity on the anteromedial region of arm and gluteal~     region, 4 months after initiating the treatment, based on the assessment of the corporal side~     randomized to be the first to receive treatment . Considering as an alternative hypothesis of~     interest a 70% value of the subjects the treated side would have higher GAIS than the~     untreated side.~   "
26163|NCT03224507|"~     Multiple myeloma (MM), a plasma cell disorder, is the second most common hematologic~     malignancy in the U.S. No standard curative therapy has yet been found. A variety of~     therapeutic measures including high dose melphalan, induction therapy, and continuous therapy~     have been used but the goal of complete response without relapse has not been achieved. More~     active treatment regimens and better tools for response assessment are needed.~   "
26113|NCT03225157|"~     Background:~      Cisplatin is a chemotherapy drug. It is used to treat head and neck squamous cell carcinoma~     (HNSCC) and other cancers. It can cause hearing loss for some people. It is not known how~     many people will get hearing loss from cisplatin. It is also not known what other factors~     might influence who gets hearing loss. Factors could include age, sex, noise exposure, and~     other drugs the person is taking. Statins are drugs used to lower cholesterol. Statins may~     also reduce cisplatin-induced hearing loss.~      Objectives:~      To see if statins reduce hearing loss in people getting cisplatin therapy to treat HNSCC. To~     find out how many people taking cisplatin get hearing loss from it. To find out if other~     factors might influence whether cisplatin causes hearing loss.~      Eligibility:~      People ages 18 and older who are getting treatment with cisplatin for HNSCC~      Design:~      Participants will be screened with a review of their medical records.~      Participants will have 3 visits. These will be before the onset of cisplatin therapy, at~     about 4 weeks after they finish therapy, and about 6 months after they finish therapy. Each~     visit will include:~      Medication history~      Audiogram/hearing tests. Participants will wear headphones and indicate when they hear~     different sounds.~      Questions about their noise exposure history and whether they have ringing in the ears~   "
26114|NCT03225144|"~     Objectives~      The primary objective is to screen patients who are referred with a diagnosis of~     frontotemporal dementia, motor neuron disorder, or related adult-onset neurodegenerative~     disorder to assess patient eligibility for ongoing protocols. The secondary objective is to~     develop and maintain a registry of characterized patients who may be eligible for future~     trials. An exploratory objective is to obtain biospecimens from clinically characterized~     patients to carry out laboratory-based studies aimed at understanding the molecular pathways~     and genetic overlap between these neurodegenerative disorders.~      Study population~      Adults referred with clinical diagnoses of frontotemporal dementia, motor neuron disorder, or~     related adult-onset neurodegenerative disorder.~      Design~      Participants will all undergo diagnostic screening tests, a standard battery of tests to~     measure cognitive and motor function, and blood for clinical testing and research. Additional~     diagnostic and research testing, including magnetic resonance imaging, electromyography,~     neuropsychological testing, lumbar puncture, and skin biopsy will be obtained in selected~     patients.~      Outcome measures~      Patients will be screened for eligibility for current research protocol or entered into a~     registry future research protocols~   "
26115|NCT03225131|"~     Background:~      Macular degeneration can cause permanent loss of central vision. This vision is important for~     seeing details. Age-related macular degeneration (AMD) is the leading cause of vision loss in~     people over 55 in the United States. Researchers want to follow people with AMD to study the~     early to middle stages of the disease.~      Objective:~      To follow for another 5 years participants who completed NIH study 11-EI-0147.~      Eligibility:~      Participant was enrolled in and completed study 11-EI-0147.~      Design:~      Participants will have at least 6 study visits over 5 years. Each visit takes about 5 hours.~      At visit 1, participants will be asked about their medical and eye disease history. They will~     have an eye exam. The exam will test vision, eye pressure, and eye movements. The pupil will~     be dilated with eye drops.~      Participants will have baseline exams. These include a health history and questions about~     problems that affect their eyes under different lighting. They will answer these questions~     each year.~      At each visit, participants will have some or all of these tests:~      Eye exam~      Dark adaptation protocol. This measures how fast the eyes recover when exposed to decreasing~     levels of light. The pupil will be dilated with eye drops. Participants will sit in front of~     a metal box with a camera inside. They will push a button when they see a light in the~     machine.~      View a bright background light for 5 minutes. After the light is turned off participants will~     push a button when a blue or red light is seen.~      Sit in the dark for about 30 minutes. Participants will push a button when they see a blue or~     red light.~   "
26116|NCT03225118|"~     Background:~      The immune system helps the body fight off disease. Most people infected with HIV cannot~     control the infection and need daily medicine. Combination antiretroviral therapy (cART) are~     drugs taken to prevent HIV infection from damaging the immune system. Researchers want to~     study why some people develop resistance to the drugs or have permanent side effects.~      Objective:~      To study the impact of a short-term treatment stop on HIV that persists even while taking~     cART.~      Eligibility:~      Adults 18-65 years old with HIV who are being treated with cART~      Design:~        -  Participants will first be screened with a physical exam and medical history. They may~          have a chest x-ray. They will have heart, blood, and urine tests.~        -  At the baseline visit, participants will repeat the screening tests except the x-ray.~          They will get counseling about HIV and risk behavior.~        -  Participants will have leukapheresis. Blood will be removed through a needle in one arm.~          A machine will separate white blood cells from the rest of the blood. The remainder of~          the blood will be returned to the body by a different needle.~        -  Participants will stop their current treatment on day 0. They will visit the clinic each~          week until they meet the criteria to restart cART. These visits will have the same~          procedures as the baseline visit.~        -  Before restarting cART, most participants will have leukapheresis.~        -  After restart, participants will be seen weekly for 4 weeks and then monthly for about~          11 months. Participants will have blood drawn, physical exam, and medical history. They~          will have leukapheresis 2 more times over 1 year.~   "
26117|NCT03225105|"~     This dose-escalation study will evaluate the safety, tolerability, pharmacokinetic (PK),~     pharmacodynamic, and signs of clinical efficacy of M3541 in combination with fractionated~     palliative radiotherapy (RT) in subjects with solid tumors with malignant lesions in the~     thorax, abdominal cavity, head and neck region, or extremities likely to benefit from~     palliative RT.~   "
26118|NCT03225092|"~     This study will investigate the potential effects of platelet rich plasma for the treatment~     of persistent medial knee pain after total knee arthroplasty. All study participants will~     receive PRP injections and will be followed up to see if any benefit in regards to pain~     and/or function is achieved.~   "
26119|NCT03225079|"~     International registry on the use of Pentaglobin® in patients with severe bacterial~     infections; multicentric, international registry, non-interventional trial~   "
26176|NCT03224338|"~     Multicenter, single-arm, open-label clinical trial to evaluate the efficacy, the safety and~     the tolerability of 50 mg dolutegravir once daily (q.d.) given in combination with 2 NRTIs~     backbone in HIV-2 positive, treatment-naïve subjects.~   "
26121|NCT03225053|"~     A headache is a more common disorder and one that prevails over a lifetime of much of the~     population. Among the causes are in the stress and spasms of the pericranial musculature,~     presence of painful sensitivity in the region, decrease of pain threshold, and a presence of~     trigger points (PGs) that can also cause as headaches. The solutions for health and health,~     in addition to Percutaneous Microelectrolysis (MEP®), which is used in the application of low~     intensity galvanic current through the acupuncture needle. Although it is a very common~     pathology, it is still little studied and a lack of information is a question of solutions~     such as crisis of care. This work justifies the negative bones of CTT in university students,~     as this has repercussions on the quality of life, besides proposing a therapeutic approach to~     reduce the symptomatology. The present study aims to investigate the effects of myofascial~     release techniques, MEP® and an association of therapies, observing the impact on quality of~     life and repercussions on academic performance. This is a controlled clinical trial of a~     convenience-based approach, consisting of universities between the 1st and 10th Physical~     Therapy course of Estácio Ponta Negra, over 18 years of age, who are not present in the~     application of the questionnaires, It is necessary to use the medicine of the analgesic type.~     The volunteers are evaluated through the HIT-6 and SF-36 questionnaires, after a selection of~     pain evaluation, PGs and algometry. The randomization will consist of 4 groups, after a~     consultation and an immediate re-evaluation and a second time and a new intervention and~     re-evaluation. A descriptive and inferential statistics will be performed through the SPSS~     20.0 program. The normality of the data is observed by the Kolmogorov-Smirnov (KS) test. For~     a comparison between groups whose parametric data are applied or anova test with post hoc~     tukey comingue of significance of 5% (p <0.05). It is believed that the use of the~     association of myofascial release techniques and Percutaneous Microelectronics promotes~     greater benefits in tension headache.~   "
26122|NCT03225040|"~     The investigators will conduct a cross-sectional study of bone density, bone~     microarchitecture, vertebral fractures and trabecular bone score in 25 patients with~     acromegaly treated with Pegvisomant, the growth hormone (GH) receptor antagonist for at least~     1 year and with normal insulin-like growth factor-1 (IGF-1) levels. This study aims to~     describe the bone architecture and associated biochemical indices of bone turnover and~     metabolism in patients with active acromegaly and how these are altered with treatment of the~     disease.~   "
26123|NCT03225027|"~     The purpose of the present study is to evaluate the effect of emotional prosody on the~     perception of emotional discourse in the schizophrenic spectrum. The investigators~     hypothesize that participant may use emotional prosody as an emotional cue to understand the~     emotional content of discourse.~   "
26124|NCT03225014|"~     Accelerated Recovery Performance (ARP) Wave therapy is an electromyostimulation therapy~     designed to enhance neuromuscular control in order to rehabilitate patients with~     musculoskeletal pathology. The outcomes of this technology have not been assessed under the~     rigors of clinical science. This prospective randomized crossover study will assess ARP Wave~     to both shorten duration of therapy and determine other advantages in the treatment of~     adolescent anterior knee pain. Two cohorts of teenagers will be followed weekly through~     either physical therapy (PT) or ARP Wave therapy, physiological therapy versus neurological~     therapy, respectively. Results should highlight the clinical utility of this modality and~     provide pilot data for future study.~   "
26125|NCT03225001|"~     To assess the safety and effectiveness of the SAPIEN XT transcatheter heart valve in patients~     with a failing surgical aortic bioprosthetic valve.~   "
26126|NCT03224988|"~     This project is focused on the gap in understanding of bilateral brain interactions and their~     role in helping normative and clinical elderly populations maintain cognitive health. The~     investigator will focus on investigating this neural mechanism of these interactions and~     promoting them with a precise application of TMS, in order to test the hypothesis that~     excitatory interactions between the hemispheres can provide positive outcomes for patients~     with pre-clinical AD (amnestic Mild Cognitive Impairment or MCI-AD). In Session 1, the~     investigator will establish the spatial specificity of bilateral brain mechanisms with~     combination of behavior, TMS, and structural neuroimaging in cortical sites known to be~     active during memory encoding. In Session 2, the investigator will establish the underlying~     dynamics of interhemispheric communication using a novel combination of TMS and~     electroencephalography (EEG) to establish the coordinated activity between the hemispheres;~     Lastly, in Session 3, the investigator will use the TMS entraining parameters delineated in~     Aim 2 to promote specific cross-hemispheric communication, applied to participants performing~     a Picture Encoding task, a general task of memory performance. The outcome of these studies~     will allow our group to evaluate the strength of this brain stimulation protocol in~     alleviating age-related and dementia-related cognitive decline, and enable development of~     novel treatment protocols for dementia in elderly cohorts.~   "
26127|NCT03224975|"~     Pain is complex phenomenon misunderstood in spite of medical progress and neurosciences.~     That's why the relief of chronic pain is only partial for a lot of infection as arthrosis,~     chronic back pain, headaches or neuropathic pain. Certain situations bring to relive pain~     sensation. Investigators were interested to former burned. They wonder about somatic memory~     and unconscious of acute.~   "
26128|NCT03224962|"~     This study will be conducted to compare the diagnostic predictive values of a light induced~     fluorescence camera and Caries detection dye versus visual assessment method in~     identification of occlusal carious lesion.~   "
26129|NCT03224949|"~     The availability of biological samples from individuals with alcoholic liver disease (ALD),~     as well as samples from appropriate heavy drinking, yet healthy controls and non-drinking~     healthy controls, is an essential first step in the translation of basic research advances to~     the clinic. The purpose of the Clinical Core component of the P50 Northern Ohio Alcohol~     Center (NOAC) is to provide biological samples (plasma/serum, buffy coats, and urine) from~     patients with different stages of alcoholic liver disease, as well as healthy control~     subjects, to members of the NOAC. These samples can then be used to test specific hypotheses~     related to the presence of specific biomarkers in the serum, functional immune activity in~     PBMCs and/or genetic polymorphisms that may predict severity of disease, short- and long-term~     morbidity and mortality and/or responsivity to specific therapeutic interventions commonly~     used in clinical practice. This study is building on the established biorepositories and the~     diversity of outstanding clinical expertise at the Cleveland Clinic. This biorepository~     included clinical samples (plasma, serum, buffy coats, and urine) from patients with~     different stages of ALD and subjects who are heavy drinkers without ALD, recruited from the~     Cleveland Clinic alcohol use disorder treatment clinic. This study will be responsible for~     collecting more data to help build the CCF-ALD biorepository via subject recruitment and~     communication and specimen collection.~   "
26172|NCT03224390|"~     The specific aim of this pilot study is to estimate the impact of a new digital health~     service on the uptake of family planning among Kenyan women with an unmet need for~     contraception. Enrolled women will be randomized to a control arm or an encouragement arm~     that will receive a special invitation to try the new service.~   "
26131|NCT03224923|"~     In patients with heart attacks, the current standard of care is to restore blood flow through~     percutaneous coronary intervention (PCI). This is done using stents (metal meshes) that opens~     up blockages. Following PCI, standard preventative drug treatment includes the use of dual~     antiplatelet therapy (DAPT) using both aspirin and a platelet P2Y12 receptor inhibitor~     (Ticagrelor 90 mg twice a day or Clopidogrel 75 mg once a day) for one year to prevent~     clotting that can result in additional heart attacks, sudden clotting of stents or death.~      New studies have shown that there is a benefit to continuing DAPT beyond this one year mark.~     Longer-term DAPT has been shown to reduce ischemic events (heart attack, stroke) but increase~     the risk of bleeding. Present guidelines state that the decision to continue DAPT beyond the~     one year mark should be made on an individualized basis.~      The present study is a pilot study that seeks to compare Long-Term use of Ticagrelor (LTT)~     versus a Personalized Approach (PA). We will be recruiting patients who have been stable~     (free of ischemic or bleeding outcomes) on DAPT for 1 year after initial presentation with a~     heart attack.~      The PA group will use a modified DAPT score based on patient demographics to decide whether~     treatment is warranted. Patient will also undergo bedside genetic testing to identify~     potential at-risk genes. Those identified as carriers will be treated with ticagrelor while~     non-carriers will be treated with clopidogrel.~      The present study will determine whether a personalized approach will decrease bleeding~     versus an approach of universal ticagrelor use.~      The hypothesis is that patients receiving a personalized strategy will have a decreased risk~     of bleeding.~   "
26132|NCT03224910|"~     Cytopathologists work along with radiologist in the diagnosis of lesions. Rapid on site~     interpretation (ROSE) of fine needle aspiration (FNA) smears of radiologically suspicious~     lesions is a common clinical practice. In the last years, the investigators have seen trend~     towards needle core biopsies of radiologically suspicious lesions. The investigators want to~     analyze the challenges of rapid on site interpretation of touch imprints (TI) of needle core~     biopsies (NCB) versus fine needle aspiration smears.~   "
26133|NCT03224897|"~     This study aims to investigate the role of the left ventrolateral prefrontal cortex (VLPFC)~     on cognitive reappraisal, using the reinterpretation strategy. For this purpose, we will~     produce direct disturbance to the activity of this area through anodal and cathodal~     transcranial direct current stimulation during a reinterpretation task.~      A double-blind randomized sham-controlled trial will be conducted. 60 healthy volunteers will~     be allocated into three groups. Each group will receive one type of stimulation (anodal,~     cathodal or sham) while accomplishing a cognitive task on reinterpretation using images from~     the International Affective Pictures System (IAPS). The task consists in applying a given~     emotional regulation condition (downregulate, upregulate or maintain emotions) to a series of~     images and ranking the intensity of the emotional arousal felt after doing this procedure to~     each picture. The effects of tDCS on the subjective evaluation of emotional arousal after~     reinterpretation in each group will be compared.~   "
26134|NCT03224884|"~     Interscalene brachial plexus block constitutes the analgesic criterion standard for shoulder~     surgery. However it is associated with a high incidence of hemidiaphragmatic paralysis (HDP)~     that may not be tolerated by patients with chronic pulmonary disease.~      This randomized controlled trial will compare ultrasound-guided interscalene block (ISB) and~     supraclavicular block in patients undergoing arthroscopic shoulder surgery.~      The main outcome is static pain at 30 minutes after arrival in the post anesthesia care unit~     (PACU) as measured by a numerical rate scale (NRS) from 0 to 10.~      Our research hypothesis is that interscalene and supraclavicular blocks will result in~     equivalent postoperative analgesia at 30 minutes in the PACU. The equivalence margin is set~     at 2 points~   "
26135|NCT03224871|"~     The advent of checkpoint blockade immunotherapy has revolutionized the management of~     metastatic non-small cell lung cancer (NSCLC). Despite the promising evidence for deep and~     durable responses with these agents the majority of patients fail to respond. The~     investigators hypothesize that a novel strategy combining radiotherapy and intralesional~     interleukin-2 (IL-2), a signaling molecule and member of the cytokine family involved in the~     activation of leukocytes and lymphocytes, may overcome resistance to checkpoint blockade~     therapy and offer significant clinical benefit to patients who fail to respond to checkpoint~     blockade alone. The investigators propose a microtrial testing the feasibility of a bold~     combinatorial immunotherapy strategy consisting of radiotherapy (RT), intralesional IL-2, and~     check-point blockade for metastatic non-small cell lung cancer patients who have progressed~     after checkpoint inhibition. IL-2 can upregulate PD-1 expression and activate T-cells.~   "
26136|NCT03224858|"~     This is a prospective randomized wait-list control study to determine whether a stand-alone,~     co-located team of physician, mental health behaviorist, and care coordinators with decreased~     panel size (aka intensive primary care) will reduce inpatient and emergency care~     utilization, inpatient costs of care, and improve patient activation and experience for~     medically and socially complex patients, compared to enhanced usual care at 6 and 12 months.~     Participants with multiple co-morbidities, and meet utilization criteria will have the~     opportunity to enroll; half the participants will start the intervention immediately, while~     half will continue enhanced usual care for 6 months before beginning the intervention.~   "
26137|NCT03224845|"~     Anxiety disorders usually start in childhood and adolescence and are associated with social~     and occupational difficulties in adulthood. Children who have a parent with an anxiety~     disorder and who find new situations distressing and avoid them are at an increased risk for~     developing an anxiety disorder. Research suggests that anti-anxiety parenting can help~     children grow up courageous and calm. It is, however, difficult to parent in an anti-anxiety~     way when the parent has an anxiety disorder himself or herself.~      This research study will test the efficacy of a new program designed to prevent the onset or~     persistence of anxiety disorders in children at risk for anxiety disorders. The investigators~     will first help parents learn skills to cope with their own anxiety and then coach them to~     share these skills with their children and parent in an anti-anxiety way. The goal is to~     intervene early enough in the children's lives so that they can be free of anxiety disorders~     and lead happy, healthy and productive lives in adulthood.~   "
26177|NCT03224325|"~     The purpose of this study is to evaluate the safety and tolerability of TAK-831 when~     administered as multiple oral doses at escalating dose levels in healthy participants.~   "
26138|NCT03224832|"~     The definitions for R0 and R1 margin status after resection for pancreatic cancer are~     controversial.Various studies showed the rate of noncurative resections of 15- 35 % but with~     modified pathological examination (R1/R2) revealed the rate of R1 resection was higher~     ranging from 76-85 % .~      Verbeke CS etal.~        -  Whether this discrepancy was caused by incomplete lymphnode dissection, perineural~          dissection and improper pathological examination was not yet known.~        -  Perineural invasion was detected in 77 % of specimens of resected pancreatic cancers.~      So the researchers emphasized the need of new surgical classification involving mesopancreas.~     It can be considered as an anatomical space bounded anteriorly by the the posterior surface~     of the pancreatic neck, posteriorly by the pancreaticoduodenal coalescence fascia, medially~     by the mesenteric vessels with -nerves, lymphatics and vessels as its contents.~   "
26139|NCT03224819|"~     This is a first-in-human, open-label, phase 1, sequential dose escalation study. AMG 673 will~     be evaluated as a short term intravenous (IV) infusion in adult subjects with~     relapsed/refractory AML. The study will be conducted at approximately 7 sites in the United~     States, Australia and Germany.~   "
26140|NCT03224806|"~     Health organizations recommend fiber-rich and whole-grain foods for healthy diets due to~     their physiological beneficial effects on human health. But, little information is available~     between these 2 food categories, i.e. fiber added to foods versus fiber naturally present in~     foods. The present study investigated the effect of enriching white wheat flour with wheat~     bran at 2 levels (15 and 30%) to produce 15% fiber-rich bread (15FRB) and 30% fiber-rich~     bread (30FRB) and compared them with white bread (WB) and whole-grain bread (WGB) in terms of~     bread quality, palatability, satiety, and glycemic response. Ten healthy subjects were~     studied on 4 separate days with each subject testing all 4 types of bread. On each test day~     subjects came to the test center after an overnight fast. After 2 fasting finger-prick blood~     samples, they ate a portion of one of the breads containing 50g available carbohydrate and~     had further blood samples at intervals over 2 hours. They also rated their feelings of~     satiety fasting and at intervals over 2 hours.~   "
26141|NCT03224793|"~     To assess the safety and tolerability of single, subcutaneous (SC) doses of BIIB059 in~     healthy Japanese subjects.~   "
26142|NCT03224780|"~     Placenta accreta is a potentially life-threatening obstetric condition that requires a~     multidisciplinary approach to management.Diagnosis of placenta accreta before delivery~     minimizes potential maternal or neonatal morbidity and mortality. In this study the~     researchers will evaluate the role and cost effectiveness of biochemical marker as creatine~     kinase in comparison with 3D Doppler ultrasound in antenatal diagnosis of placenta accreta~     and its variants in patients with placenta previa totalis.~   "
26143|NCT03224767|"~     This phase II trial studies how well vemurafenib and cobimetinib work in treating patients~     with BRAF V600E mutation positive craniopharyngioma. Vemurafenib and cobimetinib may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
26144|NCT03224754|"~     According to the guidelines for reporting thyroid fine needle aspirations known as The~     Bethesda System, the category of atypical cells known as AUS/ FLUS category has an estimated~     rate of 5 to 15% for malignancy. This study aims to determine the rate of malignancy of this~     category in our institution and to evaluate the clinical outcome of the participants.~   "
26145|NCT03224741|"~     The investigators propose to conduct a randomized controlled trial in collaboration with the~     Fundacion Raices, a non-governmental organization (NGO) with strong ties to the local~     community of Esmeraldas, Ecuador. A total of about 3,000 subjects will be involved in the~     full-scale study over the course of 2 years. In partnership with the Fundacion Raices, the~     research team will set up stands at four public places in the city of Esmeraldas: the~     malecon (esplanade on the town's waterfront), the Centro Comercial Multiplaza~     (Esmeraldas' large shopping mall), the municipal market (a popular destination for groceries,~     etc.), and a public park located in the city center. Each stand will feature a sign inviting~     individuals to stop and get their health checked, and will provide free refreshments (juice~     boxes and water). A monitor will approach individuals at the malecon/shopping~     center/municipal market/public park and ask whether they are interested to learn about a~     health initiative by the Fundacion Raices and a group of public health researchers. If an~     individual is interested, the monitor will begin the three steps of the experiment:~        1. Participants fill out a brief, anonymous survey with demographics, socio- economic~          characteristics, and whether they have been tested for HIV/AIDS in the past.~        2. Participants receive the script and actions associated with the experimental condition~          into which they are assigned to according to the randomization table.~           There are three experimental conditions:~           T1 = Information. T2 = Active Choice. T3 = Monetary incentive.~        3. Whether participants subsequently showed up at a medical facility to get tested for~          HIV/AIDS is noted in the record.~   "
26146|NCT03224728|"~     Purpose: To compare the effect of spherical aberration on optical quality in eyes with two~     different aspherical intraocular lenses Methods: In this prospective, randomized clinical~     trial 120 eyes of 60 patients underwent phacoemulsification. In patient's eyes an~     aberration-free aspherical IOL (Aspira-aA; Human Optics) or an aberration-correcting~     aspherical IOL (Tecnis ZCB00; Abott Medical Optics) were randomly implanted. Three months~     after surgery visual acuity, contrast sensitivity, wavefront measurements with iTrace as well~     as tilt and decentration measurements with Visante anterior segment OCT were performed.~   "
26173|NCT03224377|"~     Rheumatoid arthritis (RA) is a chronic systemic disease affecting primarily the synovium,~     leading to joint damage and bone destruction(Gravallese E,2002). It is probably the most~     common autoimmune disease, It is three times more common in women compared to men and usually~     appears in middle age(poulsom and charles, 2016) .Early diagnosis of RA and its early~     treatment with disease-modifying anti rheumatic drugs lead to better control and less joint~     damage .therefore,It is very important to find an acceptable serological marker in order to~     make an early diagnosis and initiate early treatment to avoid complication and disability (~     Orozco C,and Olsen,2006)~      Various serum biomarkers are used to diagnose RA, including many autoantibodies. However,~     only rheumatoid factor (RF) and anticyclic citrullinated peptide (anti-CCP) antibodies have~     wide acceptance (taylor et 2011).~   "
26174|NCT03224364|"~     To determine the safety and feasibility of solo laparoscopic appendectomy, which is defined~     as the application of solo surgery to laparoscopic appendectomy, by comparing consecutive~     non-solo procedures conducted by a surgeon in the presence or absence of human assistant(s).~   "
26147|NCT03224715|"~     It is well known that ultraviolet (UV) light causes sunburn and DNA damage that can lead to~     skin cancer. Despite preventative measures of sunscreens and other topicals the incidence of~     skin cancers continues to increase every year. Chronic exposure can lead to development of~     both basal and squamous cell carcinoma that also is correlated to the risk of melanoma. When~     epidermal keratinocytes are exposed to UV radiation, they form cyclobutane pyrimidine dimmers~     (CPDs), 6-pyrimidine-4-pyrimidones (6-4-PPs), and oxygen radicals that alter the structure of~     nucleotides. When these lesions are not repaired, DNA replication is altered that leads to~     mutations in p53 and PTCH tumor suppressor gene and ultimately tumor development. It has been~     discovered that intracellular delivery of bacterial DNA incision repair enzyme T4~     endonuclease V DNA repair enzymes can repair sun induced damaged DNA in patients with~     xeroderma pigmentosum4,. Yarosh et al also showed that T4 endonuclease V DNA repair enzymes~     are specific to reducing the amount of cyclobutane pyrimidine dimers and were found to lower~     the rate of new actinic keratoses compared to placebo lotion by 68% with no adverse effects~     observed. Additionally Yarosh et al also showed that T4N5 liposomes can repair keratinocyte~     DNA in skin cancer patients. This study will examine if pretreating actinic cheilitis with~     DNA repair enzyme cream before standard treatments can decrease the need for additional and~     possibly more aggressive therapies, decrease the surface area of affected areas, and possibly~     improve skin thickening and texture.~   "
26148|NCT03224702|"~     This First-In-Human trial will be conducted in healthy male subjects to explore the safety,~     tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics of single doses of~     M6495.~   "
26149|NCT03224689|"~     Prospective, multi-centre, non-comparative, post-market surveillance clinical study~   "
26150|NCT03224676|"~     Aim of the study was to assess the quality of sleep among adult patients, to explore the~     perceived sleep distractors among adult patients, to determine the relationship between~     quality of sleep and perceived sleep distractors score among adult patients.~      and to determine the association of quality of sleep and perceived sleep distractors score~     among adult patients with selected variables.~   "
26151|NCT03224663|"~     The study evaluates the effectiveness of Module based learning and Mobile application based~     learning regarding Facility based newborn care among nursing students.Total 70 Nursing~     students were randomly allocated to MBL and MABL group . First 35 students received MBL based~     teaching and next 35 students received MABL teaching.~   "
26152|NCT03224650|"~     The investigators are prospectively validating a prognostic clinical tool that uses a~     patient's modified Bauer grade, ambulatory status, and pre-operative serum albumin to predict~     survival, post-treatment morbidity, and functional outcomes in patients with metastatic~     disease involving the spine.~   "
26153|NCT03224637|"~     Osteoarthritis (OA) affects aged above 45 years. RF has been used for several painful~     conditions. There have been a few attempts to use RF current for the treatment of painful~     conditions of joints of the extremities. It was also used for the treatment of painful~     conditions of the hip joint.~   "
26154|NCT03224624|"~     Hypertension is the most common medical problem among US Veterans. Treatment is available and~     effective, but control rates remain under 75%. While blood pressure control has traditionally~     been achieved through sequential visits and medication changes initiated by providers during~     office-based care, self-monitoring and self-management of blood pressure medication is an~     important strategy that would empower Veterans to achieve better control of blood pressure.~     The health impacts of better systems for treatment of hypertension are significant, including~     decreased rates of cardiovascular and kidney disease.~      This two-site clinical trial will randomize 400 Veterans to either usual blood pressure care~     or a self-management strategy in which patient-driven self-management of blood pressure~     medications will be taught and used over the course of 1 year.~   "
26155|NCT03224611|"~     Flexible LMA (Laryngeal mask airway) is very useful for variable situation but it is hard to~     insert in correct position because of it's flexible structure. Especially in classical way of~     manual LMA insertion, when the index finger could not guide the flexible LMA to the optimal~     position, we could not guarantee the correct position of the LMA. Therefore several studies~     have been investigated to improve this.~      The light wand is a kind of stylet which have a light on the tip. Recently some studies~     demonstrated the usefulness of the light wand which could be used for indicating correct~     position of the LMA. We hypothesised there will be two advantages if the light wand is used~     as a stylet of the flexible LMA. First the stylet could support the mildness of the flexible~     LMA, and second the lightness could confirm the correct position of the flexible LMA.~   "
26156|NCT03224598|"~     Evaluate the safety and efficacy of hydrogen peroxide, A-101 Solution 40% for the treatment~     of DPN lesions on subjects with a Fitzpatrick Skin Type of 5 or 6.~   "
26157|NCT03224585|"~     The goal of this study is to determine the safety and efficacy of anakinra for the treatment~     of acute pericarditis when initiated within 6 hours of diagnosis and continued for 3 or 7~     days.~        1. to determine the efficacy of anakinra with respect to chest pain resolution~        2. to determine the safety of anakinra with respect to adverse drug events~   "
26158|NCT03224572|"~     This study determines whether high dose vitamin C is effective for quality of life in~     terminal cancer patients.~   "
26159|NCT03224559|"~     This study seeks to understand at how noninvasive electrical brain stimulation might change~     how people perform on on tasks requiring concentration and thinking skills.~   "
26160|NCT03224546|"~     Reduced drug use is a clinically meaningful target for treatment development, but few studies~     have evaluated the positive impacts produced by this behavioral change, preventing adoption~     of this endpoint in clinical trials. The proposed research will fill that critical knowledge~     gap by demonstrating the biopsychosocial benefits of reduced cocaine use. These data will be~     used to change current accepted cocaine treatment endpoints and accelerate identification of~     therapies for cocaine use disorder.~   "
26161|NCT03224533|"~     Multiple NHANES surveys were combined and weighted to evaluate relationships between walnut~     consumption and type 2 diabetes mellitus using various independent measures of diabetes~     status and risk. After risks were ascertained, interactions with gender were analyzed.~   "
26162|NCT03224520|"~     The research study, Smoker-to-Smoker (S2S) Peer Marketing and Messaging to Disseminate~     Tobacco Interventions will test two smoker-driven, social marketing innovations to recruit~     and engage smokers in Decide2Quit.org (Decide2Quit), which is an evidence-based, effective~     Digital Intervention for Smoking Cessation.~   "
26164|NCT03224494|"~     BACKGROUND & AIMS: Bowel hypersensitivity (lower threshold for discomfort in response to~     distention of a balloon in the rectum compared to healthy controls) is a key documented~     feature in Irritable Bowel Syndrome (IBS) mechanistic studies. The use of the barostat~     catheter to assess bowel hypersensitivity has been well documented in research settings, but~     it's use is time consuming which makes it unpractical for routine clinical practice (test~     time up to 60 minutes). The Rapid Barostat Bag is a novel device used to obtain a rapid and~     simple assessment of the rectal function, which has received approval for use by Health~     Canada. Although its safety and use has been validated in healthy controls, RBB use has never~     been reported in a cohort of IBS patients. The aim of this study is to 1) evaluate bowel~     sensitivity in IBS patients, compared with healthy controls and 2) determine whether the~     sensory threshold predicts response to standard of care interventions such as diet or~     medications.~      METHODS: This is a prospective controlled study. All participants will undergo RBB testing~     and will answer a questionnaire related to bowel symptoms (IBS-SSS - IBS Severity Scoring~     System) and a questionnaire related to anxiety/depression (HADS - Hospital and Anxiety and~     Depression Scale).~      HYPOTHESIS: The investigators hypothesize that IBS patients will display lower bowel~     sensitivity thresholds than healthy controls, using the RBB device. Furthermore, we predict~     that those with a low sensory threshold (i.e. visceral hypersensitivity) are most likely to~     respond to interventions that decrease bowel distention (e.g. low FODMAP diet) or the~     medication linaclotide that is reported to decrease pain signaling.~   "
26165|NCT03224481|"~     Participants will be recruited for inclusion at a routine adjustment appointment prior to~     planned removal of the appliances. Following removal of the appliances, consenting~     participants will be randomly allocated to one of two groups by computer-generated random~     allocation. Allocation will be concealed from the treating clinician using of an opaque~     sealed envelope system. Standard stone model records will be available for all participants~     following removal of the appliances (T0).~      Participants in both groups will have follow-up scheduled for 3 (T1), 6 (T2) and 12 (T3)~     months following removal of the braces. All participants will be instructed to wear standard~     clear, plastic (Essix-type) retainers on a full-time basis for 6 months, followed by~     night-time wear for a further 6 months. A micro-electronic timer will be integrated within~     the upper Essix-type retainer. All participants will be given standard advice at each recall~     visit.~      Participants in the intervention group will receive tailored electronic reminders in the form~     of a mobile application. The frequency and content of the reminders will be informed by~     qualitative interviews involving participants from an allied trial, and from posts related to~     orthodontic retainers shared on social media. Instructions on the necessary duration of~     retention, maintenance of retainers, departmental details, allied to advice on appropriate~     management for appliance breakages, and delineation of the implication of suboptimal retainer~     wear will be included. Also, information related the debond visit and maintenance of optimal~     oral hygiene levels will be incorporated in the mobile application. Participants in the~     control group will not receive additional reminders. Treating clinicians will be kept blind~     to the study group.~      All patients failing an appointment will be sent another. Those wishing to withdraw from the~     trial may do so at any point without affecting continuing care with records taken at the~     point of withdrawal from the study with data analysis on an intention to treat basis.~      Thereafter, patient experiences with electronic reminders will be evaluated on a subset of~     participants using one-to-one interviews.~   "
26166|NCT03224468|"~     This study will use a randomized controlled design to test whether patients who use medical~     marijuana, compared to a waitlist control group, experience a change in health outcomes~     (relief of symptoms, or adverse health outcomes such as new-onset symptoms of cannabis use~     disorders, neurocognitive impairments) or brain-based changes.~   "
26167|NCT03224455|"~     In this research study, investigators want to learn more about the factors that influence~     children's breathing during sleep and their sleep quality. Specifically, investigators are~     interested in factors that are related to risk of snoring, sleep apnea (a condition where~     breathing stops during sleep), and poor sleep quality.~   "
26168|NCT03224442|"~     Clinical Evaluation of Peri-Implant Soft Tissue Around Immediately Placed Implants Using PRF~     Membrane Versus The Palatal Pedicle Soft Tissue Graft: A Randomized Controlled Clinical~     Trial.~   "
26169|NCT03224429|"~     The purpose of this study is to gather decision making needs information from caregivers and~     patients with sickle cell disease (SCD) in order to develop a web-based decision aid tool.~     Study subjects will participate in interviews defining treatment decision making needs during~     which investigators will ask information about their SCD. Notes taken from these interviews~     will allow the research team to better understand current practice related to clinical~     practice and allow for better refinement of the decision aid tool.~      An additional group of participants will be asked to review the web-based Sickle Cell~     Decision Aid. Participants will be asked to describe thoughts about the site, including but~     not limited to ease of navigation, content and construction.~      This study will provide information for the conduct of a randomized controlled trial for the~     use of a web based decision aid to give patients with sickle cell disease and parent/legal~     guardian of children with sickle cell disease accurate information about risks and benefits~     of therapies and enable them to make decisions based on their individual values and~     preferences.~   "
26170|NCT03224416|"~     For decades, men who have sex with men (MSM) have carried the heaviest burden associated with~     the HIV epidemic in the United States. Although MSM represent a minority (i.e., approximately~     4%) of the male population in the United States, in 2010 MSM accounted for 78% of new HIV~     infections among males. Furthermore, the estimated number of new HIV infections attributed to~     male-to-male sexual contact is currently rising. In order to improve interventions to~     decrease transmission of HIV among MSM, it is important to have a better understanding of~     predictors of risky sexual behavior. Alcohol use is among the most reliable predictors of~     risky sexual behavior. Unfortunately, studies of alcohol use and risky sex among MSM have~     mainly relied on survey-based methods that cannot advance our understanding of the causal~     mechanisms linking acute alcohol use to HIV risk behavior.~      This study will utilize an alcohol/placebo/nonalcohol design to examine the mechanisms~     underlying the association between the acute effects of alcohol (i.e., pharmacological and~     expectancy) and risky sexual decision making in MSM. Focal mechanisms include sex-specific~     delay discounting (SSDD), and the core constructs of the Cognitive Mediation Model. The~     alcohol/placebo/nonalcohol design involves three conditions. In the alcohol condition (target~     BrAC = 0.080g%), the participant will be told he is receiving alcohol and will receive~     beverages of 1:4 parts vodka and tonic water with dashes of lime juice and mint, all mixed in~     his presence. In the placebo condition (target BrAC = 0.000g%), the participant will be told~     he is receiving alcohol but will receive beverages of 1:4 parts flat tonic water (served from~     a vodka bottle) and tonic water, with a minimal amount of vodka floated on the surface~     (using a lime juice bottle) to provide the smell and taste of vodka, with lime juice and~     mint, all mixed in his presence and served in glasses with vodka-soaked rims. In the true~     control (or nonalcohol) condition, the participant will be told he is receiving no alcohol~     and will be given water (poured in his presence) in a volume comparable to the other~     conditions. This 3-group design will enable us to test the pharmacological effects of alcohol~     while accounting for potential expectancy effects. Participants (Target N = 150-180) will be~     randomly assigned to one condition; all will undergo the same protocol, which will be~     completed within one experimental session. The study protocol consists of baseline~     assessment, followed by beverage administration, followed by post-drinking assessment of SSDD~     and sexual decision making, followed by debriefing.~   "
26171|NCT03224403|"~     To evaluate analgesic onset, efficacy, and safety of 1000 mg acetaminophen administered as~     two Test Acetaminophen 500 mg tablets (Test ACM) compared with 1000 mg acetaminophen~     administered as two commercial acetaminophen 500 mg caplets (ACM) and 400 mg ibuprofen~     administered as two commercial ibuprofen 200 mg liquid-filled capsules (IBU) in the dental~     pain model following third-molar extractions.~   "
26179|NCT03224299|"~     Objective of this study is to compare the antimicrobial properties of an investigational~     agent to an active control and a negative control when applied to specific body locations.~     Testing will be performed according to the procedures outlined in the Food and Drug~     Administration Tentative Final Monograph (TFM) for Effectiveness Testing of a Patient~     Preoperative Skin Preparation~   "
26180|NCT03224286|"~     This is a pilot study that provides the investigators with an opportunity to assess the~     application of PSM technology for patient monitoring in the NICU. This is a prospective,~     observational, cohort study.The investigators expect the duration of infant participation in~     this study to be 6 hours per single recording session with no follow-up required.~   "
26181|NCT03224273|"~     in the last years, dentistry is going to the concept of conservatism to preserve the most~     amount of tooth structure, so the evolution of new ceramic materials with invasive designs~     like (inlay- shaped and proximal box shaped) inlay retained bridge, the investigators can~     restore single missing posterior teeth with less invasive techniques and less rate of~     restoration fracture.~   "
26182|NCT03224260|"~     Access the safety, tolerability, and pharmacokinetics of BMS-986177 in healthy Japanese~     participants after multiple doses are administered.~   "
26183|NCT03224247|"~     Cesarean section is one of the oldest surgical interventions in the history of medicine.Many~     variations in cesarean section technique have been studied.The investigatory team are aiming~     to decrease blood loss during cesarean section by vertical splitting versus transverse~     cutting of muscle layer in lower segment cesarean sections to avoid uterine vessels injury.~   "
26184|NCT03224234|"~     Poor adherence to insulin regimens is reported in up to two-third of patients with diabetes;~     thus it is important to identify patients at risk and to develop strategies and tools to~     increase adherence to prescribed insulin regimens. This study will evaluate the efficacy of~     Insulclock® - small electronic device to help track date, time and dosage of the last~     injection, type of insulin used and temperature, with an alarm system to prevent insulin~     omissions and mistiming.~   "
26185|NCT03224221|"~     We conduct the clinical trial to further explore the efficacy and safety of Apatinib combined~     with chemotherapy in treating recurrent or metastatic esophageal squamous cell carcinoma~     after the failure of conventional treatments.~   "
26186|NCT03224208|"~     In the BRIM-3 trial, which was conducted in patients with previously untreated advanced~     melanoma harboring the BRAF V600E mutation, vemurafenib, a potent inhibitor of mutated BRAF,~     was associated with prolonged overall survival (OS) and progression-free survival (PFS)~     compared to dacarbazine. In the same setting, combined use of vemurafenib and cobimetinib, a~     selective inhibitor of MEK, yielded a significant improvement in PFS and response rate,~     compared to vemurafenib monotherapy, along with an advantage in OS, which did not cross the~     pre-specified significance bounderies (COBRIM trial). In treatment-naïve patients with~     mutated BRAF, both anti PD-1-based immunotherapy and BRAF-targeted agents are feasible~     therapeutic options, with the former and latter agents being associated with more durable and~     earlier responses, respectively.~      As suggested by National Comprehensive Cancer Network (NCCN) guidelines, the use of combined~     BRAF and MEK inhibitors in patients with progressive disease after immunotherapy, is also~     feasible, but it is not supported by category 1 evidence, in view of the lack of studies~     conducted in this setting.~      The main objective of this phase II trial is to evaluate the efficacy and safety of the~     combined use of vemurafenib plus cobimetinib in advanced melanoma patients who have received~     first-line systemic immunotherapy for inoperable locally advanced / metastatic disease.~   "
26187|NCT03224195|"~     The aim of this study is to explore the patient experience of acute rehabilitation after hip~     fracture surgery. We also aim to identify patient perceived barriers to rehabilitation and~     recovery after hip fracture surgery. More specifically, the objectives of this study are to:~        1. describe the rehabilitation experience of patients who underwent hip fracture surgery~          with respect to the frequency, intensity, type, and timing of rehabilitation and~        2. identify patient perceived barriers to rehabilitation and recovery related to the~          patient, their injury and their health care.~      The results of this qualitative study will inform a future feasibility cluster randomised~     controlled trial aimed at optimising acute rehabilitation after hip fracture surgery. The~     findings will help to strengthen the patient and carergiver centred approach when developing~     the intervention to optimise rehabilitation and potentially improve outcomes after hip~     fracture surgery.~   "
26188|NCT03224182|"~     This is a randomized, multicenter, two-arm, double-blind, placebo-controlled study of Qapzola~     in patients with low- to intermediate-risk NMIBC, assessed according to the 2016 American~     Urology Association (AUA) Guidelines. Specifically, only patients with the following low-to~     intermediate risk tumor characteristics will be included in the study.~      2016 American Urological Association Stratification for Non-Muscle Invasive Bladder Cancer:~      Low Risk~        -  Low grade solitary Ta ≤3cm: a~        -  PUNLMP: a, b~      Intermediate Risk~        -  Recurrence within 1 year, low-grade Ta: a~        -  Solitary low-grade Ta >3 cm: a~        -  Low-grade Ta, multifocal: a~        -  High-grade Ta, ≤3 cm (solitary tumor): a~   "
26189|NCT03224169|"~     To screen the prevalence of multidrug resistant organisms among the resident in the~     residential care home for the elderly, and assess the practicability of directly observed~     hand hygiene in this setting.~   "
26190|NCT03224156|"~     PREDICT-DCM Trial is a multi-centre, prospective observational trial including patients with~     DCM undergoing cardiac magnetic resonance imaging (CMR) prior to ICD or event recorder~     implantation.~   "
26203|NCT03223987|"~     Before and after study in obese women 25-35 years old, BMI 30-35, taking Strath® Kräuterhefe~     Original (liquid), Herbal Yeast Food Supplement for three weeks. At the beginning and after~     three weeks of the study a stool sample is provided. These samples are analysed with 16S rRNA~     analysis down to species level.The results are interpreted with the PICRUSt classification~     and Alpha Diversity Analysis and compared to internationally accepted data bases.~   "
26204|NCT03223974|"~     The objective of this study is to evaluate the safety and efficacy of paclitaxel-coated~     balloon in treatment of coronary bifurcation lesions. This is a feasible study to demonstrate~     the noninferiority of paclitaxel Drug-coated balloon(DCB) only strategy for bifurcation~     lesions when compared with traditional single drug eluting stent(DES) strategy, so as to~     simplify the procedure for treatment of coronary bifurcation lesions and extending the~     clinical indications of paclitaxel DCB in China.~   "
26191|NCT03224143|"~     This study is a randomized single-blind controlled trial with parallel arms.The present study~     is based on that previously published by Pezzati and collegues (2014) and it is part of a~     larger project focusing on Doll Therapy dissemination in Canton Ticino through team training~     and supervision and guidelines definition that led to the establishment of the Ticino Doll~     Therapy Group with support of the Canton Office for elderly and home care.~      The first hypothesis regards the 30 days-effectiveness efficacy of the Doll Therapy~     intervention in reducing symptoms of behavioral disorders (BPSD) that appear in stressful~     situations (as in the case of a separation from a professional caregiver) and in reducing~     stress as perceived by the treating physician. Another issue to be investigated is whether~     the typical way in which a person manifested attachment behaviors during own life (classified~     in three types of mental states: secure, insecure and unresolved) is associated, once this~     person is in an advanced stage of dementia, with caregiving behaviors of the PWD during the~     doll presentation (i.e. caressing the object, talking to it and smiling).~   "
26192|NCT03224130|"~     Post-discharge nurse phone call~   "
26193|NCT03224117|"~     evaluate the efficacy and safety of DWJ211 in patient with moderate or severe submental fat~   "
26194|NCT03224104|"~     This is a three parallel cohort, open-labeled, non-randomized, multicenter study. All three~     cohorts will enroll independently.~   "
26195|NCT03224091|"~     The PROLED study is a prospective, longitudinal and naturalistic study of patients with~     Eating Disorders. Annual interviews and collection of biological samples are done, as well as~     during changes in disease course e.g. during hospitalization. Included are qualitative~     interviews, psychometric tests, questionnaires which are used to collect data on~     psychopathology. There is also collection of blood, urine and faeces.~   "
26196|NCT03224078|"~     The overall aim of INDEED is to facilitate trans-sectoral and interdisciplinary health~     services research of emergency care in Germany.~      Clinical hospital data from 15 to 20 emergency departments in Germany will be linked to~     routine ambulatory health care data provided by the Association of Statutory Health Insurance~     Physicians (Kassenärztliche Vereinigung, KV). INDEED will identify health care gaps and~     inadequate resource allocation as well as develop strategies for adaptations of the health~     care system to existing demands.~   "
26197|NCT03224065|"~     Treatment of non - tuberculosis mycobacteria lung disease is challenging. The current~     treatment used is from 2007 American Thoracic Society guidelines recommended antibiotic~     combination therapy, which is lack of validation of clinical studies. More and more studies~     have confirmed that NTM antibiotic resistant gene will affect the efficacy, such as erm(41),~     rrl to clarithromycin, rrs to amikacin and so on. This study aimed to compare the efficacy of~     guideline recommended therapy and optimized therapy according to antibiotic susceptibility -~     related genotype.Genetic testing is accomplished through GenSeizer's high-throughput gene~     capture technique.~   "
26198|NCT03224052|"~     While World Health Organization (WHO) guidelines recommend empirical antibacterial therapy as~     the standard of care in all African children with severe falciparum malaria, there are fewer~     data to guide the management of adults with the disease in low transmission settings.~      Presently WHO guidelines do not recommend empirical antibacterial therapy in adults with~     malaria in low transmission settings, instead antibacterial therapy is only clearly~     recommended in those patients in whom a serious bacterial co-infection is clinically~     suspected. However, in a pilot study in Myanmar (High Frequency of Clinically Significant~     Bacteremia in Adults Hospitalized With Falciparum Malaria PMID: 26989752) we found that 13%~     of adults hospitalized with falciparum malaria were bacteremic, with bacterial co-infection~     suspected by clinicians in the minority. Patients with serious bacterial infection are~     commonly not bacteraemic and so this probably underestimates the frequency of significant~     bacterial co-infection.~      In that pilot study, over 75% of patients received empirical antibacterial therapy on~     admission to hospital, which would not accord with published WHO guidelines as clinicians~     suspected bacterial co-infection in only 17%. However, the study's 100% survival rate - when~     over half of the patients were at high risk of death - suggests that the administration of~     antibacterial therapy may be appropriate until bacterial co-infection is excluded.~      There is also academic debate about the role of co-morbidities in the presentation of~     patients severely ill with vivax malaria. Bacterial co-infection has been reported in some -~     but by no means all - studies of severe vivax infection. It would be useful to determine the~     relative contribution of bacterial co-infection to the clinical presentation of patients with~     vivax malaria.~      By systematically seeking evidence of bacterial co-infection in all patients hospitalized at~     the study sites, this study aims to determine if the bacterial infection is really as~     prevalent as was the case in the pilot study. Accordingly it aims to determine the utility of~     a strategy that includes empirical antibacterial therapy in adults hospitalized with malaria~     in low transmission settings, until significant bactrila infection has been excluded.~   "
26199|NCT03224039|"~     This study will be a single-center, randomized, controlled trial conducted in the Brooklyn~     Hospital Center's Emergency Department (ED) expected to last 2 years. The sample size will be~     40 patients with 20 patients in each treatment arm.~      The data points to be collected in the study are as follows: baseline characteristics~     (baseline pain score, date of birth, age, gender, weight and ethnicity), NRS pain scores at~     5, 10, 20, and 30 minutes, dose of study treatment administered, incidence of adverse~     effects, time to patient discharge following administration of study treatment, patient~     satisfaction of pain control based on a 10-point Likert Scale, number of patients who~     required rescue analgesia, and amount of rescue analgesia required. 4.~      Once informed consent is obtained, patients will be randomized to receive Treatment A~     (sufentanil 0.7 mcg/kg intranasally (IN) and normal saline 1ml IV push) OR Treatment B~     (Normal saline 0.6 mL IN and morphine 0.1 mg/kg IV push). It should be noted that during the~     study period, use of additional morphine or adjuvant analgesics outside of the designated~     time intervals is allowed. The decision to use adjuvant analgesics is the decision of the~     attending physician assigned to the patient in the Emergency Department (ED).~   "
26200|NCT03224026|"~     The study is an observational blinded Validation study in pediatric patients below 3 years~     old with a diagnosis of Fever Without Source (FWS). In this study the investigators aim to~     validate the performance of a proteomic signature aiding the physicians to discriminate~     between viral and bacterial infections in febrile children. The study will also assess the~     prevalence of Human Enteroviruses (HEV), Human Parechoviruses (HPeV), Adenovirus (AdV) and~     Human Herpesvirus type 6 (HHV-6) viremia, as well as Kingella Kingae bacteremia in the study~     cohort.~   "
26201|NCT03224013|"~     Analysis corneal and refractive stability of hyperopic laser-assisted in situ keratomileusis~     (LASIK) with and without concurrent prophylactic high-fluence cross-linking (CXL).~   "
26202|NCT03224000|"~     The goal of this clinical research study is to compare the use of MRI simulations to plan~     different doses of intensity modulated radiotherapy (IMRT) to the standard IMRT dose in~     patients with low risk human papilloma virus positive oropharyngeal cancer.~   "
26205|NCT03223961|"~     This is an open-label, randomized, multicenter, phase III study~      Patients with baseline Hb comprised between 9 and 10.5g/dl will be randomized to receive EPO~     Alfa 60000 UI/week for at least 12 weeks:~        -  Either at diagnosis Or~        -  at the Hb threshold chosen for RBC transfusions (must be < 9g/dl)~   "
26206|NCT03223948|"~     High flow nasal oxygen therapy has been widely used but guidelines as to the optimal starting~     flow rate and oxygen percentage are not available. Prolonged exposure to an inappropriately~     high oxygen concentration should be avoided as there is increasing evidence that the~     production of oxygen free radicals can lead to lung damage. This pilot dose finding study~     will determine the optimal flow rate and oxygen concentration using HFNO2 for patients with~     respiratory failure requiring low, medium or high oxygen concentration from conventional low~     flow devices. An assessment will also be made of comfort and compliance with HFNO2.~   "
26207|NCT03223935|"~     An investigation on the effects of roasted pulse snacks on post-prandial glycemic and satiety~     response in healthy young adults.~   "
26208|NCT03223922|"~     This is a trial that evaluates the preservation of cognition and neuropsychiatric function~     following genu-sparing whole brain radiation in patients with brain metastases.~   "
26209|NCT03223909|"~     Efficacy and Safety of the Ophthalmic Solution PRO-087 versus Systane ® Ultra and Systane ®~     Ultra Preservative Free on the Tear Film Dysfunction Syndrome from Mild to Moderate Clinical~     trial To evaluate the effectiveness of preservative-free ophthalmic formulation PRO-087 (by~     Laboratorios Sophia, S.A. de C.V.) to restore the anatomical and physiological~     characteristics of the ocular surface, as well as its distribution and the characteristics of~     the mild to moderate tear film dysfunction syndrome compared to Systane ® Ultra and Ultra~     Systane ® preservative free (by Laboratorios Alcon, S.A. de C.V.).~      Controlled, randomized, double-blind, masked clinical study, comparing the safety and~     efficacy of preservative-free PR0-087 vs Systane Ultra with preservative and Systane Ultra~     preservative free, in subjects with mild to moderate tear film dysfunction syndrome, for a~     period of 90 days plus 15 days of remote surveillance, in which one of the three agents will~     be administered (PR0-087, Systane® Ultra or Systane® Ultra preservative free) with a q.i.d.~     dosage. in both eyes, with regular follow-up visits (5 overall).~      Best-corrected visual acuity Intraocular pressure Ocular surface Anterior segment examination~     Posterior segment examination Tear film break-up time Schirmer test Corneal epithelization~     Goblet cells count Adverse events Subjects with a clinical diagnosis of mild to moderate tear~     film dysfunction syndrome between 18 and 90 years old, without concomitant eye diseases nor~     requiring different treatments of any of the three interventions in this study They will be~     randomized in 3 groups where PRO-087, Systane® Ultra o Systane® Ultra preservative free will~     be administered.~   "
26210|NCT03223896|"~     Non-controlled pilot study. Two groups: Group A: naloxone nasal spray max 8 mg/per day; Group~     B: naloxone max 16 mg/per day. Study duration 8 weeks. No supportive therapy, but brief~     self-help booklet. Primary outcomes: adverse events, adherence and drop out analysis.~     Secondary outcome: gambling expenditure.~   "
26211|NCT03223883|"~     The proposed research is clinical study evaluating the therapeutic benefits of curcumin on~     vascular function in patients with chronic kidney disease (CKD). The study aims to establish~     that curcumin will improve endothelial function and reduce large artery stiffness by reducing~     oxidative stress and in conjunction with lowering markers of inflammation and oxidative~     stress. In addition, the study will evaluate the potential benefit of curcumin on cognitive~     function in patients with CKD.~   "
26212|NCT03223870|"~     The objective of this study is to evaluate the Fingertip Respiratory Rate algorithm~     performance of the Nonin Medical X-100SP pulse oximetry systems with the 8300AA sensors and~     Onyx 3 fingertip oximeter. There is no treatment or interventions being performed.~   "
26213|NCT03223857|"~     To evaluate the visual performance after bilateral implantation of multifocal intraocular~     lenses.~   "
26214|NCT03223844|"~     Patients with schizophrenia show enhanced dopamine synthesis capacity and release, an effect~     that can be evoked in healthy subjects by repeated amphetamine administration. Therefore for~     the first time the relationship between dopamine synthesis and release will be studied in~     healthy subjects before and after amphetamine sensitization in order to better understand~     adaptive mechanisms of the dopamine system.~   "
26215|NCT03223831|"~     To compare the efficacy of a novel partially covered (PC) versus uncovered (UC)~     pyloro-duodenal stents (DS) in unresectable malignant gastric outlet obstruction. We~     hypothesize that the use of PCDS could reduce the re-intervention rates when compared to~     UCDS.~   "
26216|NCT03223818|"~     Liver cancer was the third leading cause of cancer death in both sexes in Hong Kong and liver~     resection remains the mainstay of curative treatment. Post-operative recovery from liver~     resection has historically been fraught with a high incidence of complications, ranging from~     15-48%, and the high incidence of complications leads to prolonged hospital stay, ranging~     from 9 - 15 days, and increase costs of hospitalization. Recent advancement in the~     perioperative surgical and anesthetic management of patients undergoing liver resection has~     led to improvement in these outcomes.~      The investigators department had previously studied the impact and confirmed the benefit of~     fast-track peri-operative programs after laparoscopic colorectal surgery. Nevertheless,~     studies regarding its adoption in liver resection are limited. The investigators group had~     previously reported, in a retrospective cohort, that successful implementation of ERAS~     protocol was associated with a significantly shorten hospital stay. However, the~     peri-operative management in that study incorporated a small proportion of components~     described in ERAS programs for liver resection and there was no direct comparison with~     conventional peri-operative program.~      The aim of this study is to compare the clinical and immunological outcomes of Hong Kong~     Chinese patients undergoing liver resection for liver cancer with a conventional vs a~     fast-track perioperative program.~   "
26217|NCT03223805|"~     This study aims to determine the effects of adding the Respiratory Distress Symptom~     Intervention (RDSI) to usual care for the self management of the Respiratory Distress Symptom~     Cluster (breathlessness-cough-fatigue) for patients with lung cancer including mesothelioma.~   "
26218|NCT03223792|"~     This clinical trial will evaluate stool consistency in infants receiving one of two study~     formulas through a 14-day feeding period.~   "
26219|NCT03223779|"~     This research study is studying a drug in combination with radiation therapy as a possible~     treatment for hepatic metastases from colorectal cancer.~      The interventions involved in this study are:~        -  Trifluridine (TAS-102)~        -  Radiation Therapy~   "
26238|NCT03223532|"~     A Prospective, Randomized, Open Label Trial Comparing PrePex™ Day 7 (FRP) to a PrePex Day 0~     FRP of Male Circumcision in Resource Limited Settings.~   "
26220|NCT03223766|"~     This is a Phase IV clinical trial observing and evaluating the safety of proton therapy in~     children. Protocol therapy is not being done as part of this clinical trial. The radiation~     targeting, planning, prescribed dose, fractionation, schedule, and use of other forms of~     therapy will be done per other therapeutic protocols at St. Jude Children's Research Hospital~     (SJCRH) at the discretion of the treating physicians associated with those trials.~   "
26221|NCT03223753|"~     This randomized clinical trial studies how well web-based physical activity intervention~     works in improving long term health in children and adolescents with newly diagnosed acute~     lymphoblastic leukemia that shows a decrease in or disappearance of signs and symptoms.~     Regular physical activity after receiving treatment for cancer may help to maintain a healthy~     weight and improve energy levels and overall health.~   "
26222|NCT03223740|"~     Based upon RTOG 9904, this study is to investigate the role of preoperative chemo and~     chemoradiation for locally advanced gastric cancer.~   "
26223|NCT03223727|"~     This registry aims to evaluate the efficacy of Rad-223 treatment in a non-study population of~     CRPC patients treated earlier with Docetaxel and patients not treated earlier with Docetaxel~     and efficacy of the first subsequent therapy. The indication for treatment with Radium-223~     will be at the physician's decision. All patients treated with Radium-223 can be included in~     this registry. The registry only dictates the collection of base line characteristics,~     expansion of regular blood tests and patient reported pain scores.~   "
26224|NCT03223714|"~     This study evaluates the efficacy and safety of Conbercept ophthalmic injection. This is a~     multi-center, randomized, double-masked, placebo-controlled phase III clinical study. 237~     patients with CRVO are expected to be enrolled in the study and randomly assigned into the~     Conbercept ophthalmic injection treatment group or the control group at a ratio of 2:1.~   "
26225|NCT03223701|"~     The purpose of this study is to examine the efficacy of using Solum IV and bone marrow~     concentrate with general fluid concentrate in Transforaminal Lumbar Interbody Fusion (TLIF).~   "
26226|NCT03223688|"~     This study aims to investigate the effectiveness of early intervention program in Department~     of Children and Adolescent Psychiatry, Kaohsiung Chang Gung Memorial Hospital. The~     investigators assume that the frequency of early-intervention and degree of family~     involvement will be associate with the treatment outcome.~   "
26227|NCT03223675|"~     For newly-diagnosed patients with brain metastasis, whole brain radiation therapy (WBRT)~     probably remains a common palliative management even for those with oligometastatic brain~     disease. However, WBRT-related late sequelae, particularly a decline in neurocognitive~     functions (NCFs), are a major concern. More importantly, in patients with limited brain~     metastases and a fair/good performance status, sparing the radiosensitive and vulnerable~     structures which are responsible for essential NCFs during the WBRT course is one of the~     reasonable strategies to postpone and prevent the development of WBRT-induced neurocognitive~     impairments. Actually, radiation-related neurocognitive dysfunction is usually characterized~     as a decline involving learning and memory, in which the extremely radiosensitive hippocampus~     indeed plays a critical role. In addition to the neurocognitive preservation by virtue of~     sparing the radiosensitive structures like the hippocampus, durable intracranial tumor~     control critically depends on an escalated radiotherapeutic dose level which is adequate~     enough to eradicate gross metastatic brain lesions. Therefore, in order to achieve both~     hippocampal sparing and simultaneous integrated boost(s) to gross metastatic foci, a~     specialized WBRT technique, hippocampal avoidance during WBRT plus simultaneous integrated~     boost (SIB) will be adopted in this prospective study. Moreover, the dose-effect relationship~     would be analyzed in order to explore the correlation between the equivalent uniform dose~     (EUD) irradiating the hippocampus and the neurocognitive change/decline after the above WBRT~     course measured by objective neurocognitive test tools. Newly-diagnosed cancer patients~     harboring 1-3 gross metastatic lesions but still in fair/good performance statuses are~     potentially eligible. All recruited patients should receive baseline functional brain MRI~     examination and baseline neurobehavioral assessment. Treatment planning will be designed via~     the technique of volumetric-modulated arc therapy (VMAT) to achieve both hippocampal~     avoidance and simultaneous integrated boost(s) to gross metastatic lesions. Except for the~     above regions for which conformal avoidance or SIB is attempted, the prescribed dose to the~     remaining brain parenchyma will be consistently 3000 cGy in 12 fractions. Accordingly, a~     battery of neuropsychological measures, which includes 7 standardized neuropsychological~     tests (e.g., executive functions, verbal and non-verbal memory, working memory, and~     psychomotor speed), is used to evaluate neurobehavioral functions for our registered~     patients. The primary outcome measure is delayed recall, as determined by the change/decline~     in verbal memory or non-verbal memory, from the baseline assessment to 4 months after the~     start of the WBRT course. This prospective cohort study aims to examine thoroughly the impact~     of a specialized WBRT technique, integrating both simultaneous integrated boost(s) delivered~     to gross metastatic foci and conformal hippocampal avoidance, on the status of NCF~     change/decline in patients with oligometastatic brain disease. It is anticipated that~     intracranial local control will be more sustainable and durable resulting from the escalated~     focal dose of SIBs. Ultimately, we also expect the dose-effect relationship will be clearly~     demonstrated after investigating the correlation between the hippocampal dosimetry and the~     status of NCF change/decline after receiving HA-WBRT plus SIB.~   "
26228|NCT03223662|"~     Background:~      The number of patients with esophageal cancer keeps rising. For many patients, a combination~     of surgery, chemotherapy, and radiation is necessary to completely treat the disease.~     Usually, patients receive chemotherapy and radiation at the same time followed by surgery to~     remove the part of the esophagus with the tumor (Neoadjuvant chemoradiotherapy nCRT).~     Researchers want to learn how to make this treatment more effective.~      Objective:~      To see if biopsies before treatment can show which patients will do the best with a~     combination of chemotherapy, radiation, and surgery.~      Eligibility:~      Adults at least 18 years old with esophageal adenocarcinoma or squamous cell carcinoma who~     should be treated with chemotherapy, radiation, and surgery.~      Design:~      Patients will undergo standard testing that is routine for all patients with this disease.~     These tests include:~      Medical history~      Physical exam with activity and nutritional assessment~      Standard lab tests~      Imaging studies including a CAT scan and PET scan~      Breathing test into a machine to measure size and function of lungs.~      Biopsy for a small sample of tumor is removed by EGD: A tube inserted into the mouth under~     anesthesia~      Endoscopic ultrasound is performed in some but not all patients.~      Patients will have nCRT at the clinic or with their local doctor.~      In 6 -12 weeks after nCRT, patients will undergo surgery with:~        1. A robotically-assisted, minimally-invasive esophagectomy~        2. Or, a traditional, open approach.~      After surgery, patients are usually in the hospital for 2 weeks and have a feeding tube for~     at least 2 weeks and potentially longer until they are eating enough to not lose weight.~      Patients will return for follow-up visits with labs and CAT scans every 6 months for the~     first two years then every year afterwards.~   "
26229|NCT03223649|"~     Background:~      Some studies have found that people can better process sugars when they take walking breaks.~     Studies have also found that children's attention and memory may improve after exercise. It~     is not known if short walking breaks have the same effects. Researchers want to study if~     breaking up sitting with walking for 6 days helps children s bodies use sugars and improves~     concentration.~      Objectives:~      To learn if breaking up sedentary (low-activity) time with short walking breaks over 6 days~     affects how children s bodies use sugar. To learn if breaking up sedentary time changes~     children s attention, memory, feelings, activity, or eating.~      Eligibility:~      Children ages 7-11 in general good health~      Design:~      Participants will be screened with:~        -  Medical history~        -  Physical exam~        -  Fasting blood tests. On 2 out of 7 total study visits, participants cannot eat or drink~          after 10 p.m. the night before.~        -  Full-body X-ray~        -  EKG (Electronic signals that record heart function through stickers)~        -  Treadmill exercise. Heart, blood pressure, and oxygen will be monitored.~        -  Questions about the child s health, socialization, and activity, and parent s education~          and economic status~        -  Picture vocabulary test~        -  Dietician meeting (Questions about eating habits)~      Participants will have visits on 6 consecutive days. Over that time, they will wear 2 devices~     to monitor blood sugar and activity (even while at home).~      Participants will have 5 after-school visits. These include:~        -  Health check~        -  Snack plus food for the next 24 hours~        -  Activity monitored~        -  3-hour sitting tests. Participants will do non-active things. Some will have 3-minute~          walks every 30 minutes.~        -  Cognitive tests and questions about mood and anxiety are given on days #1 & 5.~      Participants will fast before the last visit in the morning. They will have:~        -  9 blood draws by IV catheter. Participants will drink sugar water.~        -  Sitting test~        -  Activity monitored~        -  Meal (food buffet)~   "
26230|NCT03223636|"~     Background:~      Little is known about the time it takes for nerve signals to go from one area of the brain to~     another. Using advanced methods for brain research, researchers want to look at the time it~     takes to send messages between different brain areas. They also want to develop new tests.~      Objectives:~      To develop tests to measure the sizes of nerve fibers in the peripheral nerve system and in~     the brain. Also to find out the different speeds that information travels in nerve fibers.~      Eligibility:~      Healthy, right-handed people ages 18-70~      Design:~      Participants will be screened with medical history and a physical exam.~      Participants will have up to 7 visits depending on the tests they choose. Visits last about~     2-4 hours and may involve the following tests:~        -  Physical exam~        -  Urine tests~        -  Magnetic resonance imaging (MRI). Participants lie on a table that slides into a~          scanner. They will be in the scanner for up to 1 hour. For some scans, sensors are~          placed on the skin. They will get earplugs for loud noises.~        -  Small, sticky pads on the skin will electrically stimulate nerves in the forearm.~        -  Transcranial magnetic stimulation (TMS). A wire coil will be held to the scalp. A brief~          electrical current passes through the coil to affect brain activity.~        -  Electroencephalography. TMS will be given to the brain. Small electrodes on the scalp~          measure brain activity. Participants may do small tasks.~        -  Electrodes on the scalp will send an electrical current to the brain.~        -  A cone with magnetic detectors will be lowered onto the head to record brain activity.~          Participants will perform various tasks.~   "
26239|NCT03223519|"~     The study is designed as a proof of concept, single-center, randomized, double-blind, placebo~     controlled study to assess the safety and efficacy of Comboprofen (Ibuprofen + Magnesium +~     Vitamin C) compared to placebo, Ibuprofen, Magnesium and Vitamin C monotherapies in the~     treatment of Delayed Onset Muscle Soreness (DOMS).~   "
26240|NCT03223506|"~     Brain is composed of several anatomical compartments separated by physiological barriers~     allowing the maintenance of homeostasis. Furthermore, brain-barriers restrain the diffusion~     of some drugs in cerebro spinal fluid (CSF) and in extracellular fluid (ECF) of brain tissue,~     making the development and optimization of dosing regimen of new drugs difficult. Most dosing~     regimen are determined from the plasma concentration because target site concentrations are~     difficult to obtain in the brain, hence making the prediction of the therapeutic effect, the~     adverse effect and the toxicity of a brain- diffused drug difficult. Although quantitative~     and qualitative differences exist in the processes governing pharmacokinetic (PK) in CSF and~     brain tissue, CSF is considered as the best surrogate of drugs penetration in the human~     brain.~      A study previously published has evaluated in rats the cerebral distribution of paracetamol,~     used as a marker of passive diffusion in the ECF by microdialysis in the striatum and in the~     CSF by microdialysis in the ventricular lateralis and the cistern magna. Authors chose~     paracetamol, as it has the property to diffuse passively and rapidly in the central nervous~     system allowing the exclusive description of the relationship between the different~     compartments of the brain. This study has first revealed an unexpected important difference~     between the distribution profiles obtained in ECF and CSF. Based on these results, authors~     developed a physiologically based PK model (PBPK) to describe their results and thereby~     offering the possibility to perform interspecies simulations to predict central nervous~     system (CNS) distribution of paracetamol in human. In this study, authors used this model to~     perform pharmaceutical extrapolations between species converting data from animal to human by~     replacing obtained data from clinical past studies describing paracetamol distribution in the~     CSF and in plasma.~      Microdialysis allows determination of free extracellular concentrations of drug in different~     tissues and also in brain. Our research team, INSERM U1070, has several past experiences with~     studies involving micro-dialysis to study the distribution of antibiotic in tissue in both~     animal and human including cerebral tissue in rat and human. Recommendation from the scholar~     society suggests that brain injured patients should benefit from a multimodal monitoring to~     optimize their care and brain perfusion. This invasive multimodal monitoring consists of~     measuring the intracranial pressure, the oxygen tissue-pressure, the estimation of the~     cerebral blood flow-rate by cranial Doppler as well as the monitoring of cerebral ischemic~     parameters by microdialysis. We also prevent systemic cerebral aggression among which,~     hyperthermia, explaining the prescription of paracetamol among a large number of brain~     injured patients. Furthermore setting up of an external ventricular draining (EVD) to treat~     an intra cranial hypertension is usually necessary to allow the continuous flow of the excess~     of CSF in the brain ventricle.~      Few studies carried on human has aimed at comparing the distribution of drugs in both the CSF~     and the brain extracellular fluid though it is established that the brain barriers differ in~     their permeability as well as the drug's concentrations are different between brain~     compartments. Thus by mean of monitoring through microdialysis and/or through therapeutic~     EVD, required by brain-injured patients, we aim in our study to explore the pharmacokinetic~     of paracetamol in the brain ECF, the CSF and the plasma and to validate in man the PBPK~     developed in rat.~   "
26231|NCT03223623|"~     Background:~      Little is known about the problems in brain function in focal hand dystonia (FHD) or complex~     regional pain syndrome (CRPS) dystonia. It is unclear why some CRPS patients develop dystonia~     but others do not. Researchers want to learn which area of the brain is involved in CRPS~     dystonia compared with FHD.~      Objectives:~      To understand why people with CRPS develop dystonia, and if these reasons are different in~     people with FHD.~      Eligibility:~      Adults ages 18 - 70 with CRPS dystonia OR with CRPS without dystonia OR with FHD and Healthy~     volunteers of similar age.~      Design:~      Participants will be screened with physical exam, neurological exam, and medical history.~     They may give a urine sample and will answer questions.~      Participants can have 4 - 5 outpatient visits or stay at the clinical center for~     approximately 5-6 days.~      Participants will have MRI scans. They will lie on a table that slides in and out of a~     scanner that takes pictures of their brain. They will do small tasks or be asked to imagine~     things during the scanning.~      Participants will have transcranial magnetic stimulation (TMS) sessions for a few hours, with~     breaks. A brief electrical current passing through a well insulated wire coil on the scalp~     creates a magnetic pulse. This affects brain activity. Participants may do small tasks during~     TMS.~      Participants will have the electrical activity of their muscles measured during TMS sessions.~     Small sticky pads will be attached to their hands and arms.~      Participants ability to feel 2 separate stimuli as different will be tested by using a weak~     electrical shock to their fingers. They will also be asked to feel small plastic domes with~     ridges, that may cause discomfort.~   "
26232|NCT03223610|"~     Background:~      B-cell lymphoma is a cancer of white blood cells found in the lymph nodes. It affects the~     system that fights infections and disease. Researchers want to learn how certain drugs work~     together to treat B-cell lymphomas. The drugs are venetoclax, ibrutinib, prednisone,~     obinutuzumab, and lenalidomide (ViPOR).~      Objective:~      To study the safety of ViPOR for people with B-cell lymphoma.~      Eligibility:~      People ages 18 and older with B-cell lymphoma whose cancer has returned or not improved after~     treatment~      Design:~      Participants will be screened with:~        -  Medical history~        -  Physical exam~        -  Blood, urine, and heart tests~        -  Tissue sample from previous procedure~        -  Imaging scans~        -  Registration for counseling on the risks of lenalidomide. They must get counseling at~          least every 28 days.~      Participants will have a bone marrow aspiration before treatment.~      Participants may have tumor samples taken.~      Participants will get ViPOR in 21-day cycles. For up to 6 cycles:~        -  Participants will get one drug by IV on days 1 and 2.~        -  Participants will take the other four drugs by mouth on most days. After their first~          dose of venetoclax, they will stay in the clinic for at least 8 hours and return the~          next day for monitoring. They may be admitted for more drugs or monitoring.~      Participants will keep a drug diary.~      Participants will have a physical exam and blood and urine tests at least once per cycle.~     They will have scans 4 times over 6 cycles.~      Participants will have a visit about 1 month after their last dose of study drug. They will~     then have visits every few months for 3 years, and once a year for years 4 and 5. Visits~     include a physical exam, blood tests, and scans.~   "
26233|NCT03223597|"~     Radium-223 is the 5th treatment for metastasized castration resistant prostate cancer with a~     proven overall survival benefit. The improved survival of Radium-223 over placebo was~     demonstrated in the ALSYMPCA trial, which included a miscellaneous patient population both~     docetaxel pretreated and non-pretreated. This registry aims to describe non-study patients~     treated with Radium-223 and prospectively evaluate treatment outcomes of patients with and~     without docetaxel pretreatment. Analgesic use and patient reported pain scores, efficacy of~     the subsequent therapy and overall survival will be evaluated. Moreover, clinical and~     explorative serum and blood biomarkers of Radium-223 efficacy will be explored.~   "
26234|NCT03223584|"~     Title of the research:~      Exploratory study to inventory opportunities to optimize continuity of pharmacotherapy at~     hospital discharge~      Study area:~      Care region Leuven (individual interviews), care region Bruges (individual interviews) and~     care region Mortsel (One focus group).~      Aims:~      From an explorative angle, the study aims to identify hurdles, barriers, facilitators and~     needs that general practitioners and community pharmacists experience with patients who have~     recently been discharged from a hospital. From a feasibility standpoint, the study aims to~     investigate what supportive actions are feasible and useful to optimize the care process upon~     hospital discharge. For this purpose, a discharge document for the community pharmacist will~     be shown to the healthcare professionals. The HCP will be given the opportunity to give~     feedback on this document.~      Study design:~      A non-interventional, qualitative study is set up using face-to-face, semi-structured~     interviews and a focus group.~      Study population:~      Community pharmacists and general practitioners that are employed in the study region and~     that are considered opinion leaders.~      Number of health care professionals:~      Individual interviews will be organised until there is saturation of information and no new~     elements are provided in the interviews. At least five community pharmacists and five general~     practitioners will be interviewed per care region. In addition, a focus group will take place~     in care region Mortsel.~      Procedures:~      Upon an informed consent of the healthcare professional, a semi-structured face-to-face~     interview will take place. The interview will focus on concrete patient cases, provided by~     the healthcare professional, as well as a fictional case of the researcher. In the focus~     group, data of the individual interviews will be presented and the relevance and completeness~     of the information will be assessed. Finally, the aim of the focus group is to reach a~     consensus on the research questions.~   "
26235|NCT03223571|"~     The investigators believe that the initial cerebral connectivity as well as its evolution~     immediate post-stroke could be correlated to the amount of motor recovery. Therefore a cohort~     of 21 people early post-stroke, and 6 weeks post standard routine rehabilitation will be~     analyzed. Clinical, kinematic and imaging (MRI) data will be compared with 12 healthy~     controls. Kinematic movement information has been collected within the fMRI. By integrating~     multi-modal clinical, kinematic and MRI, the study aims to identify biomarkers of recovery to~     improve patient specific evaluation post-stroke in order to adapt rehabilitation protocols~     accordingly and to improve functional gain.~   "
26236|NCT03223558|"~     The main objective of this trial is to investigate the effects of starting exercise~     rehabilitation earlier than current practice after coronary artery bypass graft(CABG) or~     Aortic/Mitral valve replacement (VR) surgery.~   "
26237|NCT03223545|"~     The purpose of this study is to evaluate a mindfulness-based cognitive therapy intervention~     delivered over the phone (MBCT-T) for women with prehypertension. MBCT-T is an evidence-based~     program that teaches meditation practices and cognitive strategies to reduce stress and~     negative emotions. It targets psychosocial risk factors that disproportionately affect women,~     including rumination (i.e., negative thinking) and low social support. Investigators plan to~     translate the established MBCT-T program into Spanish, conduct focus groups to inform~     cultural adaptations that may be needed for Latina women, and run a pilot randomized~     controlled trial to test the feasibility, acceptability and effects of MBCT-T on blood~     pressure and perceived stress in diverse women with prehypertension.~   "
26241|NCT03223493|"~     The ACTION (Awareness, Care, and Treatment In Obesity management) study aims to identify~     perceptions, attitudes, behaviours, and potential barriers to effective obesity care across~     three respondent types: 1) People with Obesity, 2) Healthcare Providers and 3) Employer~     Representatives in the US. Data is collected via online surveys using a cross-sectional,~     US-based stratified sample design.~   "
26242|NCT03223480|"~     Surgical gastrojejunostomy is the conventional treatment for palliating patients suffering~     from of inoperable malignant gastric outlet obstruction (GOO). Although, the procedure is~     associated with a high success and low re-intervention rates, there is a risk of morbidities~     (10% - 16%) and mortalities (7%). The placement of a pyloro-duodenal self-expandable metallic~     stent (DSEMS) is an alternative to surgery for the palliating these patients. As compared to~     surgery, the procedure is associated with shorter hospital stay, reduced morbidities and~     cost. However, the clinical efficacy of DSEMS is limited by several problems. In uncovered~     DSEMS, the long-term patency is reduced by tumor ingrowth leading to subsequent re-stenosis.~     In covered DSEMS, stent migration occurs at a frequency of 14 - 25% and it is a major~     obstacle to stent patency. As a result, randomized trials comparing uncovered DSEMS and~     partially or fully covered DSEMS in patients with malignant GOO have reported comparable~     stent patency between the two types of stents.~      Recently, the creation of a gastrojejunostomy under EUS (EUS-GJ) guidance using~     lumen-apposing stents has been described 12-16. The procedure was associated with a technical~     success rate of around 90% and clinical success of 85% to 100%. The procedure holds the~     potential to create a gastrojejunostomy without surgery. Furthermore, there is a low risk of~     tumor ingrowth and stent migration, thus improving the stent patency and reducing the need of~     re-intervention. However, there is limited data on how EPASS compares to endoscopic stenting.~     The aim of the current study is thus to compare prospective data on EPASS versus a historical~     group that received DSEMS.~   "
26243|NCT03223467|"~     Obstructive sleep apnea is defined as a repetitive collapse of the pharynx during sleep~     (Malhotra, et al. 2012) which cases intermittent hypoxia. Snoring, witnessed apnea, fatigue~     and morning headache are symptoms of the disease which has severe health effect (Malhotra. et~     al. 2012) including increased mortality risk (Ensrud. et al. 2012) and effects on quality of~     life (Kuhn. et al. 2017).~      Obesity, male sex and age are all risk factors for obstructive sleep apnea (Schwartz. et al.~     2010, Edwards. et al. 2010) . Bariatric surgery is known to be a good treatment to achieve a~     sustained weight loss but the long term effects of bariatric treatment of obstructive sleep~     apnea is not well studied. The aim of this study is therefore to study the long effects of~     bariatric surgery as a treatment for obstructive sleep apnea and to find predictors that can~     be used to predict the severity of the disease.~   "
26244|NCT03223454|"~     This project aims to investigate the safety and effectiveness of human amniotic epithelial~     cells in the treatment of the severe refractory Asherman's syndrome.~   "
26245|NCT03223441|"~     Vascular stiffness increases as a person ages, due to the repetitive stress that is put on~     the vascular system which causes changes in the elasticity of the vessel walls. The increased~     stiffness of the arteries puts added stress on the circulatory system. This rise in stiffness~     has been shown to be associated with an increased risk of cardiovascular events, in both~     presumably healthy patients, as well as elderly patients The current method for assessing~     perioperative cardiac risk is the Goldman's Revised Cardiac Risk Index (RCRI). This method,~     however, does not include a direct measurement of arterial stiffness. Applanation tonometry~     is a non-invasive technique that has been shown to reliably provide indices of arterial~     stiffness While the use of applanation tonometry has been widely studied in general medicine,~     it is has not been studied for pre-operative risk assessment in surgical patients.~      The purpose of this investigation is to examine whether aortic stiffness is an independent~     risk factor for developing cardiovascular related adverse events in patients who are having~     major surgery under general anesthesia.~      Applanation tonometry will be performed on the right carotid and femoral arteries to assess~     carotid-femoral pulse wave velocity, a surrogate for aortic stiffness. (SphygmoCor system,~     AtCor Medical, Sydney, Australia). The measurement will be obtained before induction of~     general anesthesia in the presurgical area. Patients' medical history, intraoperative~     hemodynamics, and any postoperative complications will be recorded to determine significant~     correlations and relationships. This information will potentially help identify future~     patients that might be at greater risk of developing an adverse cardiovascular event~     following their surgical procedure.~   "
26246|NCT03223428|"~     The primary objective of the study is to estimate the proportion of carcinoid syndrome (CS)~     patients who are satisfied with their overall symptom control, 6 months after initiating~     treatment with telotristat ethyl (XERMELO).~   "
26247|NCT03223415|"~     Background: There is an urgent need to develop new strategies to prevent Clostridium~     difficile infections (CDI). A recent study suggests that a novel infection control bundle (IC~     bundle) can lead to a significant decrease in the incidence of CDI in acute-care hospitals.~     This IC bundle consists in screening patients for C. difficile carriage upon their admission~     combined with implementation of isolation precautions for carriers. Further investigations~     are required to confirm these findings.~      Objective: To evaluate the feasibility of implementing a multicenter interventional study to~     further to investigate the efficacy of this IC bundle.~      Methods: Prospective, cluster randomized feasibility trial of 2 infection control strategies~     (a standard and an experimental strategy) to reduce transmission of C. difficile among~     patients in 20 medical wards in 5 acute-care facilities in Quebec. Wards will be randomized~     (1:1) to one of the 2 interventions. Each intervention will be applied to all patients~     present on selected wards. The study will be divided into (1) a 3-month baseline period; (2)~     a 2-week randomization and implementation period; and (3) an 8-week intervention period.~      Intervention: The experimental strategy includes the components of the above-mentioned IC~     bundle. The standard strategy will not implement the IC bundle.~      Outcomes: As a feasibility study, process evaluation will form the primary and secondary~     outcomes. These outcomes will allow to determine whether a future main trial is possible and~     desirable.~      Hypothesis: We hypothesize that the intervention will be implementable across the study~     wards.~      Significance: This study is essential to plan a subsequent definitive trial to determine~     whether the IC bundle can prevent CDI.~   "
26261|NCT03223233|"~     The serum procalcitonin levels are important during infections and sepsis. The investigators~     aimed to assess its predictive value in terms of post-cesarean wound infection.~   "
26248|NCT03223402|"~     Type of study: Investigator initiated clinical study Study design: One arm, open label, pilot~     study (n=10) Research question Is treatment with Nevirapine + 3TC sufficient for HIV~     maintenance Risk Category B (no investigational drugs, non standard Tx) Therapies with 2~     drugs are often done in HIV-maintenance. This is a systematical evaluation of such a two drug~     trial. Rescue therapy is well defined within the protocol. Centers (n) St. Gallen only~     Participants 10 HIV Patients already on nevirapine + 2 non-nuke RT-Inhibitors Study duration~     24 weeks primary observation period after study termination, patients may opt to continue on~     the bi-therapy. Clinical follow up will then continue Sponsor/Investigator Pietro Vernazza,~     Kantonsspital St. Gallen Principal investigator Pietro Vernazza, MD. Kantonsspital St. Gallen~     Co-Investigators Patrick Schmid, MD, Matthias Hoffmann, MD~      Financial source None (Pilot Study) If study demonstrates good results, an SNF grant proposal~     will be submitted~   "
26249|NCT03223389|"~     To investigate the effects of different fat metabolites on gut hormone secretion in gastric~     bypass operated subjects and BMI-matched controls.~   "
26250|NCT03223376|"~     Fruquintinib 4mg once daily in 4 weeks treatment cycle (three weeks on and one week off) in~     combination with Paclitaxel 80mg/m2 （day1, 8, 15 of 4 weeks cycle) was well tolerated and~     demonstrated encouraging preliminary clinical antitumor activity in patients with advanced GC~     in ph1b/2 study. This study is aimed to evaluate the efficacy and safety of Fruquintinib in~     combination with Paclitaxel in the treatment of patients with aGC who have progressed after~     first line standard chemotherapy.~   "
26251|NCT03223363|"~     To determine the value of principal component analysis in the combined method of~     three-dimensional ultrasonography assessing fetal limb volume and circumference and~     conventional two-dimensional ultrasonography for prediction of birth weight in southern~     Chinese population.~   "
26252|NCT03223350|"~     This is a phase 2 randomized controlled trial testing the effect of topical capsaicin for the~     relieve of nausea and vomiting.~   "
26253|NCT03223337|"~     Daprodustat (GSK1278863), is a small molecule currently in development for the treatment of~     anemia of chronic kidney disease (CKD). Results of the earlier studies shows that liver is~     involved in the clearance of Daprodustat and hence, hepatic impairment can affect Daprodustat~     levels in the body. This single dose study will assess the effect of liver impairment on the~     pharmacokinetics (PK) and pharmacodynamics (PD) of daprodustat. The study will be conducted~     in two parts, Part 1 will include subjects with moderate hepatic impairment and matched~     healthy control subjects whereas Part 2 will include subjects will either mild or severe~     hepatic impairment and matched healthy control subjects. Approximately 8 subjects will be~     included in each of the group and all subjects will receive 6 milligram (mg) of daprodustat~     as a single oral dose in the fasted state. Total duration of participation in the study for a~     subject will be up to 7 weeks.~   "
26254|NCT03223324|"~     To study the equivalence of the Monica Novii™ Patch System in patients admitted for~     threatened pre-term labor and for pre-term labor & delivery from 32 +0 weeks gestation by~     determining the equivalence of the Novii™ Patch System in monitoring Fetal Heart Rate (FHR),~     Maternal Heart Rate (MHR) and Uterine Contractions (UC) to Doppler FHR, tocodynamometer~     (TOCO) UC and photo plethysmograph MHR FDA approved predicates~   "
26255|NCT03223311|"~     Since the development of custom-made fenestrated and branched endografts a novel therapeutic~     option for the management of thoracoabdominal and para-renal aortic aneurysms was made~     accessible. Because of the design of these branched endografts, an arterial vascular access~     from the upper limb is required to allow selective catheterization of the branch component~     and the respective target vessel (celiac trunk, superior mesenteric artery, renal artery).2~   "
26256|NCT03223298|"~     This study aims to determine whether the injection of botulinum toxin A or placebo~     (unpreserved 0.9% sodium chloride) into the masseter and temporalis muscles provides pain~     relief and improved jaw function in those who suffer from myofascial pain disorder. The study~     hypothesis is that botulinum toxin A injection is superior to placebo. The specific research~     questions are:~        1. Is the injection of botulinum toxin A superior to placebo for the improvement in pain?~        2. Is the injection of botulinum toxin A superior to placebo for the improvement in~          function or quality of life (QOL)?~        3. Are there any adverse effects that result from injection of botulinum toxin A or placebo~          into the masseters and temporalis muscles? Limited data exists to support the use of~          botulinum toxin A in the management of myofascial pain disorder of the masticatory~          region. Botulinum toxin A is not FDA approved for intra-muscular injection within the~          masticatory region. Its use in the masticatory region is considered off-label but~          performed without significant known complications. This study will provide the~          opportunity to quantitate and qualitate any complications in a large prospective sample~          of patients.~   "
26257|NCT03223285|"~     The aim of this study is to evaluate the effect of diaphragm's manual therapy in addition to~     cervical spine manual therapy in terms of pain, cervical spine range of motion, trigger~     points pain pressure threshold, disability and quality of life in patient with chronic~     aspecific neck pain.~   "
26258|NCT03223272|"~     The study is deigned to determine if refractory hypertension is attributable to heightened~     sympathetic tone by quantifying the antihypertensive benefit of reserpine, a sympatholytic~     agent, in patients failing other classes of antihypertensive agents.~   "
26259|NCT03223259|"~     A group of dance educators will attend two dance injury prevention workshops hosted by the~     Harkness Center for Dance Injuries (HCDI), NYU Langone Medical Center, during which~     participants will learn strategies to help them train their students in safe ways and impart~     injury prevention information through their dance classes to their students. The educators~     will take pre- and post-workshop tests to assess knowledge and perceptions of dance medicine.~     Several weeks later, participants will take a follow-up survey to assess knowledge~     implementation and workshop effectiveness.~   "
26260|NCT03223246|"~     Acetaminophen and ibuprofen are two of the most commonly used medication products among~     children <12 years old, and these medications are frequently prescribed for patients leaving~     the emergency department (ED), but previous studies have shown that parents often leave the~     ED unsure of how to safely dose these medications at home. This study will be a randomized~     controlled trial of a brief medication safety intervention, and examining parental knowledge~     and implementation of appropriate weight-based dosing.~   "
26263|NCT03223207|"~     The primary objective of this research is to determine if evaluating CIEDs using CareLink~     Express® can lead to shorter time to interrogation in the Emergency Department compared to~     evaluation of devices using traditional evaluation procedures. The goal of the research is to~     determine if patients evaluated by CareLink Express® have a reduction of time to~     interrogation compared to the traditional patient cohort.~      Secondary objectives of the study are to determine any significant differences in the two~     populations regarding:~        1. Health care resource utilization including total charges for ED care.~        2. Number of patients leaving the ED without being seen (LWBS) or left without the device~          interrogation completed.~        3. Device related issues detected.~   "
26264|NCT03223194|"~     This is a Phase 1/2, multinational, open-label, ascending-dose, delayed-treatment concurrent~     control clinical study to evaluate the safety and preliminary efficacy of AT342 in subjects~     with Crigler-Najjar aged ≥1 year. Subjects will receive a single dose of AT342 and will be~     followed for safety and efficacy for 5 years.~   "
26265|NCT03223181|"~     In this study the investigators aimed to evaluate diagnostic accuracy the scoring tool used~     to determine cow's milk protein allergy, the cow's milk related symptom score, is based on~     the gastrointestinal, respiratory system and dermatological symptoms being together in young~     Turkish children.~   "
26266|NCT03223168|"~     The purpose of this study is to assess for acute hemodynamic changes after implementation of~     noninvasive negative pressure ventilation (as compared with spontaneous respiration) in~     pediatric patients with Fontan failure using modern negative pressure ventilators~   "
26267|NCT03223155|"~     Trial Design~        -  Patients with stage IV non-small cell lung cancer are randomized to nivolumab/ipilimumab~          plus either sequential or concurrent stereotactic body radiotherapy (SBRT).~        -  The primary endpoint is the phase I safety endpoint of SBRT dose for each body site.~        -  The same starting SBRT dose levels are used in each arm. If two or more patients~          experience a dose-limiting toxicity (DLT) at the starting dose level, then the reduced~          dose level will be used (Section 7.1—Page 72).~        -  DLT is defined as any grade ≥3 toxicity possibly, likely, or definitely related to SBRT~          plus nivolumab/ipilimumab (the combination and not the individual components).~        -  Irradiated metastases will be grouped into one of five locations, which have different~          SBRT doses, and the DLTs will be attributed to the relevant organ system.~        -  The starting and decreased SBRT dose levels are found in Table 2 (Page 20).~        -  SBRT will be delivered in 3-5 fractions over the course of 1-1.5 weeks.~        -  Patients in the sequential arm will begin immunotherapy between 1-7 days after~          completion of SBRT~        -  Given the accrual data for IRB15-1130, the investigators anticipate that approximately~          1/3 of patients will contribute metastasis to 2 locations. Since there are 2 arms, and 5~          metastasis locations with 6 patients per location for the starting dose level, this~          translates to 40 patients for the starting dose level, and another 40 patients should~          each of the 5 locations require de-escalation to the lower dose level.~        -  Secondary endpoints include comparisons of efficacy and toxicity between the arms, as~          well as interrogation of changes in the immune microenvironment induced by the two~          approaches.~   "
26268|NCT03223142|"~     This study will document for the safety and efficacy of image guided multi-mode precision~     ablation system (the combination of cryoablation and radiofrequency ablation) for the~     treatment of liver malignant, as well as provide the indicator of antitumor immune response~     for liver malignant in China.~   "
26269|NCT03223129|"~     Bariatric surgery has been proven to be an effective treatment of type 2 diabetes and it has~     highlighted to role of the small intestine in glucose homeostasis. Improvement of glucose~     homeostasis occurs just a few days after the bariatric surgery, where parts of the small~     intestine is bypassed, has been performed. Furthermore, conditioned medium from the duodenum~     and the jejunum from both diabetic rodents and humans are able to induce insulin resistance~     in normal mice and in myocytes. Hence the hypothesis is that the small intestine secretes~     factors that are able to induce insulin resistance.~      This project aims to study how orally ingested glucose is able to induce insulin resistance~     and if this response differs in patients with normal glucose tolerance, impaired glucose~     tolerance and in patients with type 2 diabetes mellitus. To address this question glucose~     homeostasis will be studied by comparing whole body glucose uptake during a progressively~     increased oral glucose load with a graded glucose infusion where the blood glucose levels~     will be kept in the same range as during the oral glucose load in patients with normal~     glucose tolerance, impaired glucose tolerance and patients with type 2 diabetes mellitus.~      Previous studied have shown that different metabolites and bile acids could be involved the~     regulation of glucose homeostasis. Hence, it is possible that the gut regulates metabolites~     that could be involved in small intestine-induced insulin resistance described above. The aim~     of this research is to study metabolomics in plasma collected during the oral glucose~     tolerance test with increasing load of glucose and the graded glucose infusion where plasma~     glucose level will be held in the same levels as during the oral glucose tolerance test and~     study the differences in patients with normal glucose tolerance, impaired glucose tolerance~     and in patients with type 2 diabetes mellitus.~      The expected results in this study will demonstrate that the gut plays an important role in~     glucose homeostasis and that this system is dysregulated in type 2 diabetes. More~     importantly, novel factors derived or regulated from the gut that regulate insulin resistance~     and glucose tolerance will be identified which could be possible targets for future~     antidiabetic therapies.~   "
26270|NCT03223116|"~     This study is to evaluate the safety and efficacy of radiofrequency energy procedure for~     Gastro-esophageal reflux disease (GERD) based on changes of symptoms, medication esophagitis~     grade, esophageal acid exposure and lower esophageal sphincter pressure. Symptom assessment~     was performed at baseline and 3, 6, 12 months after treatment.~   "
26271|NCT03223103|"~     The purpose of this study is to use precision medicine in the form of a vaccine, a~     mutation-derived tumor antigen vaccine (MTA-based vaccine) in combination with standard care~     treatment of glioblastoma (GBM) and Tumor Treating Fields (TTFields).~      The study is designed to determine whether this treatment combination is well tolerated and~     safe.~   "
26272|NCT03223090|"~     This project pursues the validation of an innovative strategy to boost language learning,~     based on the benefits derived from sensorimotor training.~      The common belief of a rigid brain structure in adult life had to be reconsidered during the~     last decade. After training, local increase in cerebral cortex volume and thickness, the part~     of the brain containing neuronal cells and synapses, has been documented. Research has~     established that brain structures active during training expand while learning and return to~     baseline afterwards. The transient structural increase is thought to reflect work in~     progress within areas involved in learning, meant to integrate new skills in existing neural~     circuitries, via strengthening and/or selection of local neuronal connections. My main~     hypothesis is that other functions, as long as they rely on the activity of the same brain~     territories, can take advantage of this work in progress. To use an allegory, imagine the~     restauration of a building (brain area). It can start after the request of improvements from~     some of the residents (trained function) and then become the occasion for other tenants~     (other functions) to see realized also their own wish for improvements. In the end everybody~     will benefit from the restauration, provided that they all live in the same building and~     everybody has posed their requests during the work in progress. Out of the allegory, living~     in the same building means neural overlap of functions in the brain. The case of motor and~     linguistic systems represents, from this perspective, a unique opportunity. State-of-the-art~     research 1) proved the existence, and described the temporal evolution of brain plastic~     changes during sensorimotor learning, and 2) documented neural overlap and functional~     interactions of motor and linguistic systems. This posits solid bases for a crucial step~     forward, gravid of important consequences and applications. This project aims to take this~     step forward by directly testing the innovative hypothesis that brain changes induced by~     sensorimotor learning induce benefits for linguistic functions relying on the same brain~     territories.~   "
26273|NCT03223077|"~     Gastrointestinal (GI) infection with Campylobacter causes inflammation in the bowel and can~     change bacteria in the gut. Certain individuals with Campylobacter infection are also known~     to develop chronic bowel problems such as Irritable Bowel Syndrome (IBS). The researchers are~     doing this study to understand if changes in gut bacteria and gut mucosal lining during an~     acute infection can help identify individuals who might be at risk for developing problems in~     the future.~   "
26274|NCT03223064|"~     Following curative intended therapy in prostate cancer patients, a high proportion of~     patients (approx. 25%) relapse with local and/or distant recurrence. The metastasis of a~     lymph node (LN) in a patient with prostate cancer means that the disease has become systemic~     with the increased risk of disease progression. Therefore the ability to detect the presence~     of LN metastasis is important in terms of disease prognosis and treatment options. In the~     past, patients with LN metastasis have had poor prognoses due to the scarcity of accurate~     staging techniques and toxic treatment regimens such as radiotherapy. For those patients with~     a medium to high risk of having LN metastasis, the current procedure is a bilateral pelvic~     lymph node dissection (PLND). This is the standard procedure prior to curative treatment with~     either radical prostatectomy or radiation therapy. However, the procedure is not optimal due~     to the frequent inability to remove all positive lymph nodes within the dissection area. 41%~     of metastatic LN disease is not found, due to these LN being outside the routine surgery~     field. As a result, some urologists will perform an extended lymphadenectomy (e-PLND), which~     leads to extended operating times and the risk of complications. Also, therapy of LN~     metastases has limitations: more than 50% of metastatic LN are outside the routine (RTOG-CTV)~     radiation field. Thus the effect of standard LN radiotherapy is limited. Currently used~     imaging techniques such as CT and conventional MRI are also not sensitive enough to detect~     prostate cancer metastases due to the small size of the nodes (< 8mm).~      In this study, patients that undergo a pelvic lymph node dissection will be undergoing a 68Ga~     PSMA PET-CT and a nano-MRI prior to surgery. The results of the PSMA PET-CT and the nano-MRI~     will be validated using the pathology results of the (PLND).~   "
26275|NCT03223051|"~     The aim of this randomized study is to develop a new motor assessment of space exploration in~     a 2D environment with upper limbs for children with spinal muscular atrophy 1 and 2 from 3~     until 16 years old.~   "
26276|NCT03223038|"~     This is a multi-site study of how nutrition is delivered to critically ill patients in~     pediatric intensive care units (PICUs) around the world. Each site will include mechanically~     ventilated children in their respective PICUs and record the details of what type and amount~     of nutrition was received. These details will be compared to goals designated by the~     clinicians caring for each patient. Data will be entered in a secure online remote data~     capture tool and managed by the lead researchers in Pediatric Critical Care Nutrition at~     Boston Children's Hospital, Nilesh Mehta, MD and Lori Bechard, PhD, RD. Data will be analyzed~     to better understand how different types and amounts of nutrition impact important PICU~     outcomes such as length of stay, ventilator time, incidence of infections, and mortality.~   "
26277|NCT03223025|"~     This randomized, active-controlled, two-armed, open-label, and cross-over trial was designed~     to compare efficacy and safety of 0.03 mg/kg/day subcutaneous injections of either~     CinnaTropin® or Novo Nordisk growth hormone product in 30 children with Idiopathic Growth~     Hormone Deficiency. Patients were randomized to receive one of the products for three months.~     After that, each patient crossed over to the other arm to receive the other product for~     another three months. The primary objective of this study was to compare the efficacy of~     CinnaGen growth hormone (GH) with Nordilet. The secondary objectives of this study were~     further comparison and evaluation of efficacy along with safety between CinnaTropin® and~     Nordilet®.~   "
26278|NCT03223012|"~     This study aims to evaluate the impact of AbbVie Care 2.0 on adalimumab's compliance, patient~     reported outcomes and utilization of health resources over 12 months.~   "
26279|NCT03222999|"~     This study will evaluated the epidemiology and the outcomes of patients suffering~     out-of-hospital cardiac arrest with presumed cardiac etiology in Korea.~   "
26280|NCT03222986|"~     Systematic establishment of exosome proteomics in co-culture medium and clinical sepsis~     specimens will be done. Ubiquitination-autophagy-apoptosis biomarkers in exosomes will be~     detected and correlated to specific organ failure in sepsis. The inflammatory process also~     will be validated by cytokines analysis. NTA double markers identification will be a smart~     method to understand the exosome subpopulations.~   "
26281|NCT03222973|"~     To evaluate the effects of BIIB033 versus placebo on disability improvement over 72 weeks and~     to evaluate the effects of BIIB033 versus placebo on additional measures of disability~     improvement.~   "
26282|NCT03222960|"~     This study will be conducted to evaluate the effect of Propolis-containing toothpaste in~     comparison to Fluoride-containing Toothpaste by caries risk assessment in high caries risk~     patients.~   "
26283|NCT03222947|"~     Taybi-Linder syndrome (TALS, OMIM 210710) is a rare autosomal recessive disorder belonging to~     the group of microcephalic osteodysplastic primordial dwarfisms (MOPD). This syndrome is~     characterized by short stature, skeletal anomalies, severe microcephaly with brain~     malformations and facial dysmorphism, and is caused by mutations in RNU4ATAC. Although~     RNU4ATAC-associated TALS is a recognizable phenotype, an atypical presentation is sometimes~     observed, thus expanding the clinical spectrum (TALS-like phenotype).~      This study aims to identify new variants involved in Taybi-Linder syndrome and associated~     phenotypes (i.e.TALS-like).~      This non interventional study will be performed on patients with no proven mutation of~     RNU4ATAC and their blood relatives (19 samples total) by high throughput sequencing and~     genetic analysis of already collected deoxyribonucleic acid samples.~      Altogether, such a study will allow a better understanding of the molecular mechanisms~     responsible for the Taybi-Linder syndrome and Taybi-Linder syndrome-like phenotypes as well~     as the pathophysiology of these devastating forms of microcephalic dwarfism.~   "
26284|NCT03222934|"~     •Sphenoid sinus is located in the body of sphenoid bone, closed with a thin plate of bone~     tissue that separates it from the surrounding important structures .Detailed, meticulous~     preoperative radiological study of sphenoid sinus is the key to successful and safe~     functional endoscopic sinus surgery and transsphenoidal surgery. The purpose of the study is~     to delineate the sphenoid sinus radiologically using the multislice computed tomography and~     to decrease morbidity and mortality during skull base surgeries as the sphenoid sinus is one~     of the most variable of all sinuses and its relation to vital vascular and nervous elements~     make its approach a challenge for endoscopic surgeons~   "
26285|NCT03222921|"~     Weight bearing in 40 patients undergoing open wedge high tibial osteotomy (HTO) will be~     studied during 12 weeks for their post-operative weight bearing using a pressure insole.~   "
26286|NCT03222908|"~     To assess impact of behavioral economic principles of precommitment, implementation~     intentions, and social contracting on smoking cessation for patients undergoing surgery.~   "
26287|NCT03222895|"~     Background: Lymph node status is an important prognostic parameter in esophageal carcinoma~     and an independent predictor of survival. Distribution of metastatic lymph nodes may vary~     with tumor location, tumor histology, tumor invasion depth and neoadjuvant therapy. Surgical~     strategy depends on the distribution pattern of nodal metastases but consensus on the extent~     of lymphadenectomy differs worldwide. Especially for adenocarcinoma the distribution of lymph~     node metastases has not yet been described in large series. Aim of the present study is to~     evaluate the distribution of lymph node metastases in esophageal carcinoma specimens~     following transthoracic esophagectomy with at least a 2-field lymphadenectomy.~      Methods: The TIGER-study is a multinational observational cohort study with 58 participating~     centers. All patients with a resectable esophageal or gastro-esophageal junction carcinoma in~     whom a transthoracic esophagectomy with a 2- or 3-field lymphadenectomy is performed in~     participating centers will be included. All lymph node stations will be excised and~     separately sent for pathological examination. Cluster analysis will be performed to identify~     patterns of metastases in relation to tumor location, tumor histology, tumor invasion depth~     and neoadjuvant therapy.~      Conclusion: TIGER will provide a roadmap of the location of lymph node metastases in relation~     to tumor histology, tumor location, invasion depth, number of lymph nodes and lymph node~     metastases, pre-operative diagnostics, neo-adjuvant therapy and survival. Patient-tailored~     treatment can be developed on the basis of these results, such as the the optimal radiation~     field and extent of lymphadenectomy based on the primary tumor characteristics.~   "
26288|NCT03222882|"~     At present, the evaluation criterion of endometrial receptivity is controversial. The~     development of a molecular diagnostic tool, the endometrial receptivity array (ERA) for~     diagnosis of endometrial receptivity . But use of this test in patients with RIF has shown~     that the window of implantation (WOI) is displaced in only a quarter of these patients and~     use of a personalized embryo transfer (pET) on the day designated by ERA improves~     reproductive performance with higher cost .what is known to the others'population? The~     morphological changes observed on histology for each specific day after ovulation were~     described by Noyes and his colleagues in 1950 . An endometrial biopsy that shows a difference~     of more than 2 days between the histologic dating and actual day after ovulation is~     considered to be ''out of phase''. But such pET studies according to the Noyes criterion in~     hormone replacement cycle are lacking . The aim of this study is to explore the~     transcriptomic profile of endometrial receptivity in different histological dating of hormone~     replacement cycle and its clinical application.~   "
26289|NCT03222869|"~     This research is being done to determine the resistance across stenosis in the airway.~   "
26290|NCT03222856|"~     This a multicenter, open-label, phase II clinical trial to assess the efficacy of~     pembrolizumab in combination with eribulin in female patients older than 18 years old with~     hormone receptor-(HR)positive/HER2-negative metastatic breast cancer (MBC) previously treated~     with at least one, but not more than two, prior chemotherapeutic regimens for treatment of~     locally recurrent and/or metastatic disease. Prior therapy must have included an~     anthracycline and a taxane and prior anti-hormonal therapy is mandatory.~      The number of patients to be included is 44 patients at 11 sites. All eligible patients will~     be treated with MK3475 (pembrolizumab) 200 mg on day 1 of each 21-day cycle and eribulin 1.23~     mg/m2 (equivalent to eribulin mesylate at 1.4 mg/m2) on days 1 and 8 of every 21-day cycle.~   "
26291|NCT03222843|"~     A multicentre, randomised, double-blind,4-stages phase III study enrolled 414 patients with~     chronic, previously treated ITP. Dosage could be adjusted (2.5~.75 mg/day) to maintain~     platelet counts 50~250×109/L~   "
26292|NCT03222830|"~     At present, the evaluation criterion of endometrial receptivity is controversial. The~     development of a molecular diagnostic tool, the endometrial receptivity array (ERA) for~     diagnosis of endometrial receptivity . But use of this test in patients with RIF has shown~     that the window of implantation (WOI) is displaced in only a quarter of these patients and~     use of a personalized embryo transfer (pET) on the day designated by ERA improves~     reproductive performance with higher cost .what is known to the others'population? The~     morphological changes observed on histology for each specific day after ovulation were~     described by Noyes and his colleagues in 1950 . An endometrial biopsy that shows a difference~     of more than 2 days between the histologic dating and actual day after ovulation is~     considered to be ''out of phase''. But such pET studies according to the Noyes criterion are~     lacking . The aim of this study is to explore the transcriptomic profile of endometrial~     receptivity in different histological dating of natural cycle and its clinical application.~   "
26293|NCT03222817|"~     The proposed study will examine the implementation of a Human Papillomavirus (HPV)~     self-sampling intervention for unscreened and under-screened transgender men and~     transmasculine individuals living in South Florida. The study will enroll participants to~     receive this cervical cancer screening intervention in community venues. The purpose of this~     study is to pilot the self-sampler for feasibility and acceptability within this underserved~     population.~   "
26294|NCT03222804|"~     The purpose of this study is to determine if supplementing healthy term infants delivered~     vaginally who consume breast milk, formula, or both with a probiotic for 21 consecutive days~     increases levels of bacteria in infants' stool.~   "
26295|NCT03222791|"~     The Personalized Nutrition Project for Prediabetes (PNP3) study will investigate whether~     personalized diet intervention will improve postprandial blood glucose levels and other~     metabolic health factors in individuals with prediabetes as compared with the standard~     low-fat diet.~   "
26306|NCT03222648|"~     In this single centre non-randomised pilot cohort study we wish to quantify the effect of a~     twice weekly, 8 week, structured responsive exercise training programme on exercise~     tolerance, symptoms and health related quality of life in patients with Idiopathic Pulmonary~     Fibrosis (IPF). We also wish to assess the effect of exercise training on fibrotic processes~     causing IPF through measurement of blood biomarkers of disease activity.~   "
26307|NCT03222635|"~     Aim of this prospective multicenter study is to evaluate the safety of an endoscopic~     follow-up strategy in patients treated with endoscopic resection (ER) for submucosal~     esophageal adenocarcinoma (T1bN0M0 EAC).~   "
26308|NCT03222622|"~     This is a phase II study to evaluate the efficacy and safety of Icotinib Hydrochloride Cream~     in patients with mild to moderate psoriasis.~   "
26309|NCT03222609|"~     This is a Phase 2, single-arm, open-label, multicenter study evaluating efficacy, safety and~     tolerability of navitoclax added to ruxolitinib in participants with myelofibrosis.~   "
26296|NCT03222778|"~     In the perioperative or critical care of hemodynamically unstable patients, appropriate fluid~     resuscitation guided by reliable preload indices is of pivotal importance as only half of~     them are fluid responsive, and that empiric fluid administration actually leads to dismal~     prognosis. In the continuum of being non-invasive, combinations of tissue Doppler-derived~     parameters of early (e') and late (a') diastolic, and peak systolic velocity (s') of the~     mitral annulus provide information regarding the systolic dysfunction and preload (e'/s'),~     and LV stiffness (e'/a'). Hence, combining LVEDAI with these indices would provide~     comprehensive information regarding the LV dimension, preload, and compliance as well as~     systolic function. Yet, its role as a preload index has not been tested before. Moreover,~     these values can be reliably obtained regardless of the heart rhythm, except for a', and do~     not completely rely on heart-lung interaction as opposed to the dynamic indices. Thus, the~     aim of this prospective trial is to investigate the role of LVEDAI combined with e', a' and~     s' as a preload index in predicting fluid responsiveness in patients scheduled for off-pump~     coronary bypass surgery, both in closed- and open-chest conditions.~   "
26297|NCT03222765|"~     Background: A significant proportion of pre-diabetics, show macro and micro vascular~     complications associated with hyperglycaemia. Although many trials have demonstrated the~     efficacy of lifestyle and pharmaceutical interventions in diabetes prevention, no trial has~     evaluated the extent to which mid- and long-term complications can be prevented by early~     interventions on hyperglycaemia.~      Aims: To assess the long-term effects on multiple complications of hyperglycaemia of early~     intensive management of hyperglycaemia with linagliptin, metformin or their combination added~     to lifestyle intervention (LSI) (diet and physical activity), compared with LSI alone in~     adults with non-diabetic intermediate hyperglycaemia (IFG, IGT or both).~      Study Design: Investigator initiated (non-commercial), long-term, multi-centre, randomised,~     partially double blinded, placebo controlled, phase-IIIb clinical trial with prospective~     blinded outcome evaluation. Participants will be randomised to four parallel arms: 1) LSI + 2~     placebo tablets/day; 2) LSI + 2 Metformin tablets of 850 mg/day; 3) LSI + 1 Linagliptin~     tablets of 5 mg/day and 1 placebo; 4) LSI + 2 tablets of a fixed-dose combination of~     Linagliptin 2.5mg and Metformin 850 /day. Active intervention will last for at least 2 years.~      Setting and population: Males and Females with pre-diabetes (IFG, IGT or both) aged 45 to 74~     years selected from primary care screening programs in 14 clinical centres from 10 countries:~     Australia, Austria, Bulgaria, Greece, Italy, Kuwait, Poland, Serbia, Spain and Turkey and .~     (N=1000)~      Main Outcomes: The primary endpoint is a combined continous variable: the microvascular~     complication índex (MCI) composed by a linear combination of the Early Treatment Diabetic~     Retinopathy Study Scale (ETDRS) score (based on retinograms), the level of urinary albumin to~     creatinine ratio, and a measure of distal small fibre neuropathy (sudomotor test by~     SUDOSCAN), measured during baseline visit and at 24th and 48th month visits after~     randomisation. In addition, serological biomarkers of inflammation, vascular damage,~     non-alcoholic fatty liver disease, insulin secretion, measures of quality of life, sleep~     quality, neuropsychological evaluation and endothelial function will be also evaluated in a~     subset of participants.~   "
26298|NCT03222752|"~     Efficacy of Cranial Electrotherapy Stimulation (CES) for the treatment of Major Depressive~     Disorder~   "
26299|NCT03222739|"~     Scoliosis is a complex 3-dimensional deformity of the spine. It may occur at any time~     throughout growth and development and is typically detected through x-ray imaging. Although~     effective at visualizing a curve, x-ray imaging is costly and may expose children to~     potentially harmful ionizing radiation. This is a 30 patient study to evaluate the~     reliability of ultrasound, an imaging technique without radiation, to effectively measure~     scoliosis deformities compared to the gold-standard of x-ray.~   "
26300|NCT03222726|"~     Microvascular complications are a major complication of diabetes.Diabetic microvascular~     complications can not only lead to chronic kidney disease and retinopathy, but also affect~     the quality of life of patients with diabetic nephropathy, which can lead to the death of~     diabetic patients.Due to diabetes patient survival for decades, in spite of more than 90% of~     time is a life outside the hospital, so the analysis of the effect of outside risk factors~     for complications of hospital and progress, and to find effective intervention measures is of~     great significance for the prevention and control of diabetic microvascular~     complications.Therefore, we use of advanced Internet technology, and analysis of large data~     algorithms, and try to keep track of routine indicators such as the patient's urine in real~     time in patients' families.~      This topic mainly observe movement (step 6000 steps per day or 6000 / week) in patients with~     type 2 diabetic kidney disease microvascular end point events, provide the basis for~     prevention and control of diabetes kidney complications, clinical significance and treatment~     prospects.~   "
26301|NCT03222713|"~     The Health and Education Ministries of Brazil launched the Health in School Program - PSE -~     in 2007. The purpose of the PSE is twofold: articulate the actions of the education and~     health systems to identify risk factors and prevent them; and promote the education for~     health in the public elementary school system. In the health field, the self-regulation (SR)~     construct can contribute to the understanding of life habits which can affect the improvement~     of individuals' health. This study aims to present a school-based program, Promotion of~     Self-Regulation in Health (SRH), which adds the self-regulation approach to the topics of~     healthy eating and oral health of the PSE for elementary school. A study of a randomized~     clinical trial enrolling the 5th grade students of public elementary schools from the south~     of Brazil is presented. The study has two phases. In Phase 1, teachers and health~     professionals will participate in a training program on SRH, and in Phase 2, they will~     conduct an intervention in class: Promotion of SRH. The participants were randomly assigned~     into three groups: Condition I followed the PSE program, Condition II group followed the PSE~     and the SRH program, and the control group did not enroll in either of the health promotion~     programs. For the evaluation of the study, the following measures and instruments were~     applied: Body Mass Index (BMI), Simplified Oral Hygiene Index (OHI-S), Previous Day Food~     Questionnaire (PFDQ), Declarative Knowledge for Health Instrument, Food Preference~     Instrument, Student´s Attitudes and Perceptions and Parents Perceptions and Influences on the~     Health Instrument, Food Availability and Oral Health Instrument, Self-Regulation for Health~     Scale, Self-Efficacy for Health Scale. Students in the three groups will be assessed five~     times throughout the year: before the beginning of the intervention program, three months~     into intervention, six months into intervention, at the end of the intervention, and,~     finally, six months post intervention to check for the impact of the program on children~     health.~   "
26302|NCT03222700|"~     In the present study, The investigators investigated the effect of surgical methods on the~     recovery of patients after robotic surgery and open thyroidectomy~   "
26303|NCT03222687|"~     Henoch-Schönlein purpura (HSP) is the most common vasculitis in children, with an incidence~     of approximately 10:100 000 children and a slight male predominance (male-to-female ratio of~     1.5:1). Henoch-Schönlein purpura nephritis (HSPN) is the principal cause of morbidity for HSP~     and 1%-7% of HSPN patients may progress to renal failure or end-stage renal disease.~      Immunosuppressive therapy has become the standard treatment in children with HSPN, however~     the use of these drugs are still mainly in an off-label manner in clinical practice.~     Tacrolimus, a calcineurin inhibitor, has been recently suggested in the treatment of HSPN in~     children. However, the evidence-based clinical data are still limited.~      Given the potential benefits and unmet need in clinical practice, the purposes of this pilot~     study were to assess effectiveness and safety of tacrolimus in HSPN children and evaluate the~     potential impact of CYP3A5.~   "
26332|NCT03222310|"~     This study will be a single center, open-label, 2-period, fixed-sequence, Phase 1 drug-drug~     interaction study in healthy subjects. The primary purpose of this study is to evaluate the~     effect of itraconazole on the PK of ipatasertib and its primary metabolite (G-037720).~   "
26310|NCT03222596|"~     The most common symptom displayed in patients with multiple sclerosis (MS) is a pronounced~     sense of fatigue that can have negative effect on functional ability and quality of life~     (QOL).~      An important goal of researchers and clinicians involves improving the QOL of individuals~     with MS, and the exercise therapy represents potentially modifiable behavior that positively~     impacts on pathogenesis of MS and thus the QOL.~      However, the main barrier for its application is low motivational level that MS patients~     experience due to fatigue with adjacent reduced exercise tolerability and mobility, and~     muscle weakness. Getting individuals with MS motivated to engage in continuous physical~     activity may be particularly difficult and challenging, especially those with severe~     disability or Expanded Disability Status Scale (EDSS 6-8).~      Till now, researchers have focused their attention mainly on the moderate or vigorous~     intensity of exercise and on cardiorespiratory training in MS patients to achieve~     improvements in daily life quality, less indicating the exercise content, and most~     importantly, breathing exercises.~      In addition, it is investigators intention to make exercise for MS patients more applicable~     and accessible, motivational and easier, but most important, productive.~      Investigators think that MS patients experience more stress with aerobic exercise or moderate~     to high intensity programme exercise, and can hardly keep continuum including endurance~     exercise, or treadmill.~      Hypothesis:~      Investigators hypothesis is that 4-weeks of continuous low demanding or mild exercise~     programme with specific content and an accent on breathing exercise can attenuate primary~     fatigue in MS patients, especially in those with more severe disability or EDSS from 6-8, and~     provide maintenance of exercise motivation. Investigators also propose that important~     assistant factor for final goal achievement is social and mental support of the exercise~     group (EDSS from 0-8) led by a physiotherapist. This will help to maintain exercise~     motivation and finally make better psychophysical functioning, and thus better QOL.~   "
26311|NCT03222583|"~     A Phase 3, double-blind (DB), placebo-controlled study to evaluate the efficacy and safety of~     ABT-493/ABT-530 in non-cirrhotic chronic hepatitis C virus (HCV) genotype (GT)1 to~     GT6-infected Asian participants with or without human immunodeficiency virus (HIV)~     co-infection who are HCV treatment-naïve or treatment-experienced with interferon (IFN)~     (alpha, beta or pegylated interferon [pegIFN]) with or without ribavirin (RBV) OR sofosbuvir~     with RBV with or without IFN.~   "
26312|NCT03222570|"~     The purpose of this study is to evaluate the effectiveness of two adaptive treatment~     strategies (ATSs) for adolescent depression. The ATSs include delivery of an evidence-based~     psychotherapy (interpersonal psychotherapy for depressed adolescents, IPT-A), systematic~     symptom monitoring, and an empirically-derived algorithm that specifies whether, when, and~     how to augment IPT-A. Two hundred depressed adolescents (age 12-18) will be recruited to~     participate in a 16-week sequential multiple assignment randomized trial conducted in~     outpatient community mental health clinics. Adolescents will be randomized to the IPT-A ATS~     condition or the community clinic's usual care (UC). Adolescents in the IPT-A ATS condition~     who are insufficient responders will be randomized a second time to the addition of a~     selective serotonin reuptake inhibitor (SSRI) or more intensive IPT-A (delivered twice per~     week). Research assessments will be administered at baseline and at weeks 4, 8, 12, 16, and~     36.~   "
26313|NCT03222557|"~     This is a prospective, randomized, sham-controlled, superiority trial that aimed to~     investigate the efficacy of electroacupuncture (EA) in reducing the duration of postoperative~     ileus and hospital stay after laparoscopic total mesorectal excision or abdominoperineal~     resection for rectal cancer.~   "
26314|NCT03222544|"~     The investigators designed this prospective, randomized control study to confirm the efficacy~     and safety of indocyanine green - mediated photodynamic therapy for diabetic lower limb ulcer~     and to explore its mechanism.~   "
26315|NCT03222531|"~     To perform a study (100 patients) utilizing Hepatitis C positive donor hearts for hepatitis C~     negative donors with post-operative surveillance and treatment only if a recipient infection~     occurs.~   "
26316|NCT03222518|"~     The purpose of this study is to:~      Compare the effect of paracetamol alone against NSAIDs alone against the association of~     paracetamol + NSAIDs in the treatment of traumatic pain.~   "
26317|NCT03222505|"~     The goal of this research study was to examine the immediate effects of a prototype wearable~     robotic stride management assist device (SMA) designed by Honda R&D® on clinical walking~     performance, walking energetics, gait kinematics and corticospinal excitability in~     individuals with stroke.~   "
26318|NCT03222492|"~     There is significant unmet need for effective treatment options for Diffuse Cutaneous~     Systemic Sclerosis (dcSSc). The present study will be a dose-escalation safety trial of~     brentuximab vedotin, a drug-antibody conjugate approved for the treatment of lymphoma and~     targeted to the protein CD30 molecule expressed on activated immune cells There is evidence~     for CD30 involvement in SSc. This study represents the first step in determining safety and~     tolerability of brentuximab vedotin in SSc.~   "
26319|NCT03222479|"~     Participants were able to use the application the investigators developed for four weeks.~     With the application, the participants were able to monitor their stress level and life style~     patterns. The participants were also provided personalized stress management techniques~     including psychoeducation and cognitive behavioral technique. In 2014, additional relaxation~     techniques—abdominal breathing, progressive muscular relaxation, and meditation—were~     incorporated. Participants' mental health status and life style patterns were evaluated at~     baseline and at 4 weeks. Pre- and post-intervention statuses were compared after adjusting~     for degrees of life stress factors. Brief encounter psychosocial instrument (BEPSI-K) score~     and Center for Epidemiologic Studies Depression Scale (CES-D) score were used as primary~     outcome measures.~   "
26320|NCT03222466|"~     Although the harms of screening for prostate cancer with the prostate-specific antigen (PSA)~     test outweigh the benefits, 560,000 Ontario men undergo PSA screening each year. Guideline~     developers, such as the Canadian Task Force on Preventive Health Care (CTFPHC), have~     disseminated patient educational materials (PEMs) on PSA screening widely in Ontario, yet men~     remain confused about screening harms and benefits. One potential contributing factor may be~     that PEMs are typically developed by researchers and clinicians and may not address patient~     barriers to change. The investigators will assess whether a PSA screening PEM that is~     co-created with patients provides added value over PEMs developed using the traditional~     approach (i.e., researchers and clinicians develop a PEM with patient involvement in~     usability testing only. The investigators will also assess satisfaction with the engagement~     process and calculate the costs and resources required for each method (i.e. co-creation,~     usability, and recommendations only). This study will generate a PSA screening PEM to help~     patients make evidence-based screening decisions. It will also help Ontario organizations,~     including Cancer Care Ontario, identify optimal methods for developing PEMs for PSA screening~     and other areas of preventive health care, such as breast and colorectal cancer screening.~   "
26357|NCT03221972|"~     The aim of this study was to assess the vitamin D status and analyze risk factors for vitamin~     D inadequacy of Chinese children and adolescents aged 6-17y.~   "
26321|NCT03222453|"~     In order to study the transplantation effect of hematopoetic stem cells from beta-thalassemia~     induced pluripotent stem cells. We applied clinical grade source of autologous hematopoietic~     stem cell for the treatment of beta-thalassemia patients, detecting the homing of~     hematopoietic stem cell transplantation, the differentiation of hematopoietic stem cells in~     vivo and the hemoglobin beta-chain (HBB) protein expression in the body of recovery, etc., as~     well as to make a research on the efficacy and safety of hematopoietic stem cells from~     beta-thalassemia induced pluripotent stem cells.~   "
26322|NCT03222440|"~     SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody. This is an open-label，single~     center ，non-randomized ，Single Arm Exploratory Study . This clinical study is an~     investigator-initiatedclini-cal trial（IIT ）.The objective of this study is to evaluate the~     efficacy and safety of radiation therapy combined with anti-PD-1 antibody SHR-1210 in~     patients with Locally Advanced Esophageal Squamous Cell Carcinomas。~   "
26323|NCT03222427|"~     The purpose of this study is to measure how much LY3314814 gets into the bloodstream when it~     is given as a single dose by mouth and as an intravenous (IV) infusion over two hours. The~     study will last at least two weeks for each participant, not including screening.~   "
26324|NCT03222414|"~     The study will compare agreement of invasive blood pressure measurements with non-invasive~     blood pressure measurements measured with a conical blood pressure and large standard upper~     arm rectangular cuff in morbidly obese severely hypertensive (systolic blood pressure > 160~     mmHg) parturients.~   "
26325|NCT03222401|"~     Approximately 24 healthy male volunteers between the ages of 18 and 35 years will be enrolled~     at a single center for a duration of two months for each subject. Subjects who meet the~     enrollment criteria will be randomized to one of four open-label groups: Control (no~     treatment) or treatment with F598 at one of three doses. Following F598 administration or~     assignment to the Control group, subjects must return to the study site for inoculation with~     N. gonorrhoeae within 2 weeks. Once subjects have been inoculated with N. gonorrhoeae, they~     will enter the observation phase and will return to the study site daily for up to 5 days. At~     the end of the observation phase, definitive antibiotic therapy will be administered. A~     follow-up visit will be conducted 3-5 days after definitive antibiotic and a confirmatory~     interaction will occur with the subjects 7-10 days after the follow-up to confirm the~     subject's response. A final visit will occur approximately 8 weeks after inoculation.~   "
26326|NCT03222388|"~     Questionnaires are used within urology to objectify disease burden and symptom changes during~     therapy. Recent technological improvements, as the smartphone and tablet, create new fill-out~     possibilities. However, questionnaires are only validated on paper. In order to use~     questionnaires for multiple platforms, electronic validation is needed. The International~     Prostate Symptom Score has already been validated on the smartphone. The International Index~     of Erectile Function (normal version of 15 questions and short version of 5 questions) is~     widely used within urology, however electronic validation is required for usage on electronic~     platforms in the future.~   "
26327|NCT03222375|"~     Locomotor, transport and information functions in human body systems are carried out by~     active media in autowave regimes! Any living organism is a (micro-macro-mega) hierarchy of~     autowave subsystems-an ensemble of loosely coupled subsystems of a simpler structure. From~     the highest levels of the hierarchy, Autowave Codes-Signals arrive, which determine the~     transitions of subsystems from one autowave regime to another Autowave interaction (of~     Complex Coherent Action). Autowave interaction is a process associated with the evolution and~     interaction of spatial and wave structures in the active media of the organism.~      Chaos in organism functioning tells about health. Periodicity - Autowave reverberator may~     presage a disease - Autism Spectrum Disorder; Chaotic nature of oscillations in active media~     of physiological systems is more optimal for their vital functions than periodic one.~     Firstly, systems that function in chaotic regimes, can re-arrange themselves faster and~     easier in case of change of environmental conditions, i.e. the so called adaptive control is~     more easily implemented in them. Secondly, spreading of oscillations strength along~     comparatively wide frequency band takes place in chaotic regime.~      When an organism is young and healthy, physiological systems show the elements of chaotic~     behavior, i.e. irregularity and chaotic dynamics are the extremely important characteristics~     of health. Decrease in changeability and appearance of stable periodicity of Autowave~     reverberator are often connected with Autism.~      The main purpose is to study brain plasticity (the changes that occur in the brain through~     Autowave reverberator) in children with autism. Research suggests that during development,~     the brains of children may change in response to their Autowave reverberator differently than~     the brains of typically developing individuals. Investigators want to understand why and how~     this difference may contribute to the symptoms of autism spectrum disorder (ASD). In this~     study, the investigators will be examining the effects of non-invasive neuromodulation SQUED™~     series 28.1 home-use for Treatment of Autowave reverberator of Autism.~      Integrative Team World Organization of Medical Synergetics (WOMS) - collaborations between~     physicians and researchers with expertise in biostatistics, physics, mathematics,~     engineering, and computer science.~   "
26328|NCT03222362|"~     We reviewed the records of 120 consecutive patients (male and female), aged 85 years and~     above, who underwent pars plana vitrecromy in the Tel Aviv Medical Center during the years~     01/01/2006 - 31/12/2013, and were followed by physicians in the ophthalmology department in~     the center until December 2015.~   "
26329|NCT03222349|"~     The hypothesis of the study is that DBSF will be safe and tolerable in pediatric patients~     during the Interictal state (Period A) and the ictal/peri-ictal state (Period B) of Epilepsy,~     and pharmacokinetics will be the same during and in-between experiencing seizures.~   "
26330|NCT03222336|"~     Fabry disease is caused by the deficiency or absence of alpha-galactosidase A (α-Gal A)~     activity, leading to progressive deposition of glycosphingolipids, mainly~     globotriaosylceramide (Gb3), in the lysosomes of multiple tissues and organs. In Taiwan, Dr.~     Niu first revealed a surprisingly high incidence (approximately one in 1,600 males) of a~     cardiac variant GLA splicing mutation, IVS4+919G>A, in newborn screening. Patients who~     carried the IVS4 + 919G > A mutation and were older than 40 years had a higher prevalence of~     hypertrophic cardiomyopathy. Endocardial biopsy of these patients with hypertrophic~     cardiomyopathy showed significant Gb3 accumulation in the cardiomyocytes. Although the~     hotspot IVS4+919G>A mutation is now being observed with greater frequency, understanding of~     the natural course of cardiac variant Fabry disease with this specific mutation remains~     limited. Therefore, our study would like to conduct a study to approach the natural history~     among patients with Chinese hotspot late-onset Fabry mutation IVS4+919G>A through family~     pedigree analysis.~   "
26331|NCT03222323|"~     The aim of this trial is to investigate if dexmedetomidine prolongs the duration of an ulnar~     nerve block. By using healthy volunteers the investigators can perform bilateral ulnar nerve~     blocks and thereby control for a systemic effect to clarify if the effect is actually~     peripheral or systemic. The investigators hypothesis is that dexmedetomidine as an adjunct to~     a local anaesthetic prolongs the duration of a peripheral nerve block by a peripheral~     mechanism.~   "
26333|NCT03222297|"~     To evaluate the feasibility of CT perfusion technique to monitor the changes of blood~     perfusion in the brain tissue before and after skull repair using titanium mesh. To determine~     the best timing for skull repair using the three-dimensional titanium mesh; to compare the~     effects of early (1-3 months after decompression) and late-stage (6-12 months after~     decompression) skull repair on neurologic rehabilitation.~   "
26334|NCT03222284|"~     This is a two-armed mixed methods study of participants (n=30) diagnosed with type 2 diabetes~     who use a blood glucose meter as part of their treatment regimen. Participants will have~     either two or three visits at HITLAB during the 28-day study period.~   "
26335|NCT03222271|"~     Invasive mechanical ventilation (IMV) is associated with numerous complications. Hence,~     patients should be weaned from the ventilator as early as possible. A number of randomized~     controlled trials have addressed whether noninvasive ventilation (NIV) can facilitate weaning~     in patients failing spontaneous breathing trials (SBT)s. Compared to invasive weaning, NIV~     weaning strategy showed reduced mortality, greater weaning success, less~     ventilator-associated pneumonia, shorter length of ICU and hospital stay and less~     re-intubation rate.~      Most of the previous studies used pressure support ventilation with fixed pressure support,~     but no studies published on hybrid NIV modes.~      Intelligent Volume Assured Pressure Support (iVAPS) is a recent NIV mode, which achieves a~     target alveolar ventilation by adjusting pressure support and respiratory rate automatically.~     In iVAPS, the target is alveolar ventilation not the tidal volume, taking into account a~     predicted dead space . This new mode has been investigated in stable chronic obstructive~     pulmonary disease (COPD) patients with domiciliary NIV and it was comparable to pressure~     support ventilation (PSV) regarding improvement in oxygenation, carbon dioxide (CO2) wash and~     therapy compliance.~      Yet, less numerous studies have been performed on this mode when used for acute respiratory~     failure. These studies found that i-VAPS was comparable to PSV as regards PaCO2 and pH~     improvements, minute volume, pressure support and respiratory rate. No published data so far~     about the role of i-VAPS as a weaning mode in mechanically ventilated patients. So, this~     study aims to investigate this new mode in comparison to the standard S/T mode in weaning~     COPD patients using NIV.~   "
26336|NCT03222258|"~     This study evaluates the change of quality of life, treatment decision and utilization of~     health care depending on the use of palliative care in advanced cancer patients by a~     prospective cohort study. Participants will be separated into different groups by their~     intentions for using palliative care. Every participant will carry out the questionnaire per~     3 months. This cohort study will be ended a year after each participant enrolls. However, if~     the participant didn't survive during this study, the caregivers will be asked to fill out~     additional questionnaire after 3 months of the death.~   "
26337|NCT03222245|"~     This study is only open to sites in the Wessex CRN. The aim of diabetes treatment is to~     achieve and maintain as optimal blood glucose levels as possible to prevent unpleasant~     symptoms associated with high blood sugars and long-term complications of diabetes. This can~     be achieved with oral tablets, subcutaneous injectable diabetes therapies such as insulin or~     GLP-1 analogues.~      Injectable therapies can significantly improve glucose control, but the counter to this might~     be an increased treatment burden, patient and clinician's inertia to initiate injectable~     treatments and the potential side effects of the medications.~      These treatment aspects may critically affect patients' health related quality of life and~     satisfaction with treatment which can powerfully influence patients' compliance and~     self-management behaviours. This is an observational cohort study and its overall aim is to~     compare the health status, quality of life (QOL) and treatment satisfaction in two cohorts of~     patients with type 2 diabetes - those treated with oral diabetes drugs (nonexposed group) and~     those on subcutaneous injectable therapies (exposed group).~      The changes in the above parameters will be measured by applying three questionnaires to both~     groups of participants at baseline and after 6 months of treatment:~        1. ADDQoL measures diabetes specific quality of life~        2. DTSQ measures treatment satisfaction~        3. SF-36 measures overall health status~      Study duration is six months for each participant and over this period participants will~     receive three telephone or face to face contacts (based on their preference) with the~     research team. The questionnaires will be posted to participants at baseline and at 6 months~     and will be completed in paper form and returned to research team in pre-paid selfaddressed~     envelopes.~      It is hoped that this study will provide valuable understanding of the effect of injectable~     therapies on QOL and treatment satisfaction in our local population with type 2 diabetes~     which can then be carefully factored into clinical decisions when initiating or intensifying~     diabetes treatments.~   "
26338|NCT03222232|"~     This is an observational study evaluating a catheter salvage strategy in relation to~     catheter-related bloodstream infections in patients with chronic intestinal failure dependent~     on home parenteral support. The study is confined to the period 2002 to 2016.~   "
26339|NCT03222219|"~     The objective of this observational study is to evaluate the primary stability of dental~     implants. Clinical insertion torque data with the Implant Stability Quotient will be~     correlated.~   "
26340|NCT03222206|"~     This Study purpose to verify change of variety factors that the cause of nonalcoholic fatty~     liver disease and its process through salsalate injection to osteoarthritis patient who has~     non alcoholic fatty liver~   "
26341|NCT03222193|"~     The Tongue Right Positioner (TRP Snorless™) is a medical device designed to restore~     physiological tongue positions when functioning or at rest and increase tongue muscles tone.~     Patient wears TRP Snorless™ daily at least 5 hours during night. Published data suggested~     that TRP Snorless™ increases oropharynx diameter and nasal patency, favouring airflow in~     upper airways. Independently of patient's adherence to daily myofascial exercises, the TRP~     Snorless™ treatment should increase tongue muscles' tone and decrease the risk of snoring~     during sleep.~   "
26342|NCT03222180|"~     The first 2 years of this project consisted of user-centered design and development of an~     online resource designed by and for parents of very young children with type 1 diabetes~     (under 6 years old). That phase of the work has been completed and recruitment has begun for~     the second phase, which is a randomized controlled trial to evaluate the effects of use of~     this resource on a variety of pertinent child and parent outcomes. INTERESTED, ELIGIBLE~     PARENTS OR GUARDIANS CAN LEARN MORE BY NAVIGATING TO: www.bit.ly/youngT1D~   "
26358|NCT03221959|"~     This is a single centre, observational study with a medical device which has Conformité~     Européenne (CE) marking. The aim of the study is to demonstrate that patients with malignant~     middle cerebral artery infarction (M-MCA) show an increased intra-cranial pressure (ICP)~     compared to neurological patients without M-MCA infarction or other space-occupying~     indications.~   "
26381|NCT03221660|"~     The objective of this study is to evaluate the clinical performance of the new restorative~     F-Composite 2 system for Class I and Class II cavities that need to be restored in permanent~     teeth.~      The materials of the system can be polymerized in short time with a new curing light which is~     part of the system.~      The study will be carried out as a prospective study, with evaluation of the restorations~     after 7-10 days (baseline), at 6 months, at 12 months and at 24 months according to defined~     criteria.~   "
26343|NCT03222167|"~     This is a multi-center, open-label trial of Elbasvir/ Grazoprevir 50/100 mg fixed dose~     combination 12 week treatment aimed to evaluate SVR12 in treatment naïve patients with~     chronic hepatitis C (genotype 1b) infection, associated with of metabolic syndrome. The study~     to be conducted in conformance with Good Clinical Practices.~      A total of 60 subjects will be studied at 2 sites in the Republic of Kazakhstan.~      Males and Females treatment naïve patients with CHC genotype 1b infection associated with~     metabolic syndrome (MS), 18-70 years of age, with or without severe fibrosis / compensated~     cirrhosis will be enrolled. SVR 12 (primary endpoint) will be evaluated. Patients will be~     stratified by fibrosis stage and presence of metabolic syndrome components. Interim Analysis~     will be performed in order to estimate viral kinetics, applicability of SVR4 and durability~     of SVR12 by evaluation of virologic response at week 4 and 8 of treatment and follow-up at~     week 4 (SVR 4) and 24 will be performed - this will be a descriptive summary only without~     hypothesis testing.~      The main hypothesis is that 12-week therapy with MK-5172 in combination with MK-8742 for~     treatment-naïve patients with HCV genotype 1b with metabolic syndrome is not notably worse~     than the same course for treatment-naïve patients with HCV genotype 1b without metabolic~     syndrome.~   "
26344|NCT03222154|"~     The study consisted of 60 women who had pain-point pains in the upper fibers of the trapezius~     muscle. They had a medical age of 22.8 years, with a body mass index of 22.8 kg / cm2.They~     underwent an initial assessment, with a visual analogue pain scale, followed by an assessment~     of pain threshold, and manual muscle strength.Then, they were allocated into three groups:~     control group with 20 volunteers without intervention, placebo group with 20 volunteers with~     shock wave simulation and an intervention group with 20 volunteers with shock wave therapy.~      All volunteers were evaluated immediately after the protocol (post evaluation) and 48 hours~     after the intervention protocol (48 hour evaluation). A mixed ANOVA of repeated measurements~     was used for intra and intergroup comparisons, followed by tukey post hoc. Significance was~     set at 5% (p <0.05).~   "
26345|NCT03222141|"~     The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN~     3 transcatheter heart valve and delivery systems which are intended for use in patients with~     symptomatic, calcific, severe aortic stenosis, and are in high risk.~   "
26346|NCT03222128|"~     The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN~     3 transcatheter heart valve and delivery systems which are intended for use in patients with~     symptomatic, calcific, and severe aortic stenosis, and those with intermediate risk.~   "
26347|NCT03222102|"~     This study aims to evaluate if the risk of developing ventral hernia after liver~     transplantation can be reduced through the prophylactic implantation of a synthetic, fully~     resorbable mesh Phasix in the course of liver transplantation.~      Patients will be randomized in a 1:1 ratio to receive either Phasix mesh or standard surgery~     without the use of Phasix.~      Ultra-sound examinations of the wound area will be performed 14 days, 3, 6 and 12 months~     after liver transplantation. Furthermore, presence of infections, seroma, pain and other~     problems in the wound area will be assessed.~   "
26348|NCT03222089|"~     A randomized phase II trial of FOLFOXIRI in Combination With GM-CSF and IL-2 (FOLFOXIGIL)~     Versus FOLFOXIRI as First-line Treatment for Patients With Metastatic Colorectal Cancer.~   "
26349|NCT03222076|"~     Objectives:~      Primary Objective:~      1. To evaluate the safety and tolerability of therapy with nivolumab alone or nivolumab +~     ipilimumab in resectable HCC in the context of presurgical therapy; to evaluate the safety~     and tolerability of therapy with nivolumab + ipilimumab in potentially resectable HCC in the~     context of pre-biopsy therapy.~      Secondary Objectives:~        1. To assess the efficacy of presurgical nivolumab alone or nivolumab + ipilimumab therapy~          in HCC by estimating the objective response rate (ORR) and time to progression (TTP) per~          RECIST 1.1 progression-free survival (PFS).~        2. To estimate the conversion rate to surgery for arm 3 potentially resectable patients.~   "
26350|NCT03222063|"~     The study evaluates the effectiveness of play interventions on anxiety among hospitalized~     children in selected hospital of Yamuna Nagar, Haryana. Quasi experimental approach was~     adopted. 60 (30 in experimental and 30 in comparison)hospitalized children were selected by~     purposive sampling technique.Hospitalized children in experimental group were provided play~     interventions whereas the children in Comparison group received only usual medical and~     nursing care.~   "
26351|NCT03222050|"~     A study to assess and compare the effectiveness of Distraction techniques on Pain intensity~     during Immunization among Infants in selected hospital of Ambala, Haryana.~   "
26352|NCT03222037|"~     This is a bilateral, non-dispensing, randomized, cross-over, single-masked study. There are a~     total of 3 visits where all study endpoints will be measured in all subjects at baseline with~     habitual lenses and under the two testing treatments sequentially in separate visits based on~     the randomization scheme~   "
26353|NCT03222024|"~     This is a multi-centre, prospective cohort study. The aim of this study is to investigate~     causes, risk factors, clinical course, management and outcomes of severe ischaemic stroke in~     a real-world setting in tertiary hospitals in China. Patients with acute ischaemic stroke~     from nine tertiary hospitals in western China will be recruited. Participants will be visited~     within 24 hours after admission, on day 3, day 7 and at discharge, to collect their clinical~     data, blood biomarkers, and brain imaging. A structured telephone interview will be conducted~     for each participant at 3 months and 1 year after stroke onset, respectively, to collect~     their functional outcomes. In-hospital outcomes include haemorrhagic transformation, brain~     oedema and death, 3-month and 1-year outcomes include survival status (death or survival) and~     functional outcome (scores of modified Rankin scale, mRS).~   "
26354|NCT03222011|"~     Two thirds of patients with Crohn's disease require intestinal surgery at some time in their~     life. Intestinal strictures, that is narrowing of the bowel due to inflammation and scarring,~     are the most common reason for surgery. Despite the high frequency, associated disability,~     and cost there are no are no treatment strategies that aim to improve the outcome of this~     disease complication. The STRIDENT (stricture definition and treatment) studies aim to~     develop such strategies.~   "
26355|NCT03221998|"~     This study is designed as a population-based prospective randomized cohort study. A~     prospective cohort of patients admitted to laparoscopic sleeve gastrectomy due to morbid~     obesity~   "
26356|NCT03221985|"~     The research team will investigate whether there is a relation between smartphone usage and~     psychological parameters using the smartphone application.~   "
26359|NCT03221946|"~     Newer drug delivery systems such as transdermal patches using pain relieving or modifying~     agents emerged as mainstream treatment protocol for management of pain on the outpatient~     basis. The administration of Diclofenac 100 mg in transdermal patch in the patients having~     dental pain due to periapical/periodontal infections was evaluated.~      Methods: 90 Patients of either gender, between 18 to 80 years were divided into 3 groups~     (Group A- oral medication, Group B- transdermal patch, Group C - intra muscular group).~     Patients at the dental department with pain from periapical/periodontal pathologies were~     explained about the procedure of analgesia. With written consent, 100 mg diclofenac sodium~     transdermal patches were prescribed to patients who opted their use in pain control for 2~     consecutive days. A Visual Analog Scale was provided for all patients assessing the pain~     intensity during the study.~   "
26360|NCT03221933|"~     To preliminary assess the efficacy and safety of recombinant human growth hormone injection~     on the treatment of small for gestational age (SGA), and determine the best dose.~   "
26361|NCT03221920|"~     This study examine the effects of very low carbohydrate diet (in which the calories~     requirements are mostly from fat) to the level of systemic inflammation (measured by Glasgow~     Prognostic Score), serum lactate and TNF Alpha levels~   "
26362|NCT03221907|"~     A multi-center, randomized, double-blind, parallel, active-controlled phase III clinical~     trial to evaluate the efficacy and safety of 'GLA5PR GLARS-NF1 Tab.' and 'Pregabalin' in~     peripheral neuropathic pain~   "
26363|NCT03221894|"~     In China, herbal therapy as a complementary therapy is very popular. Should conventional~     therapy (such as donepezil and memantine) combined with herbal therapy make add-on benefit?~     Cognition, activities of daily living and behavioral symptoms will be assessed. Data will be~     collected from the medical records of patients with Alzheimer's disease (AD) in memory~     clinics.~   "
26364|NCT03221881|"~     In this study, PLD, an anthracycline encapsulated in stealth liposomes, which are believed to~     efficiently deliver the doxorubicin within the tumour mass with less toxicity compared with~     standard doxorubicin formulation was used. The study aimed to determine whether the~     combination of PLD-docetaxel would increase tumour response in patients with breast cancer.~   "
26365|NCT03221868|"~     The study aims at evaluating the effects of an intervention among diabetic women (40 years or~     older) who belong to the Basic Health Units System (Brazilian public health system). The~     novelty of this project is that the intervention is low cost and demands very little from the~     health system in terms of structure, facilities and personnel.~   "
26366|NCT03221855|"~     It is a double-blind randomized clinical trial placebo-controlled, which aims to assess~     whether Domperidone medication helps to increase milk production. The sample of 30 mothers of~     newborns in the Neonatal Intensive Care Unit of the Hospital de Clínicas de Porto Alegre for~     at least 15 days, receiving power enteral tube (without clinical condition for oral). Nursing~     mothers will be evaluated by the researcher (breastfeeding committee member) or consultants~     in breastfeeding that will advise these women about the practice of runs out of the breasts~     each mother. You receive containers for collection, at least one for each time you run out.~     These containers will measure the volume of milk. For each mother that refer insufficient~     milk production or is not maintaining adequate production for their newborn within 24 hours,~     one will be generated data form and after 15 days postpartum will be randomized and receive~     domperidone orally at a dose of 10mg 8/8 hours, or placebo in same volume. The milk volume~     will be measured daily. Three blood samples will be collected for each lactating each with 5~     ml tube without anticoagulant for analysis of serum prolactin and domperidone. The sample 01~     will be collected immediately after randomization, before receiving any medication (placebo x~     domperidone). The sample 02 on 5 of the study. And the sample 03, day 10 of the study, three~     days after the termination of the use of medication or placebo. A milk sample (5 ml) of each~     mother will be collected on day 5 to analysis of domperidone levels in milk. Once collected,~     the samples will be processed and frozen at -80o C for later analysis. All mothers will be~     followed until hospital discharge of their newborns, to monitor outcome breastfeeding~     exclusive breast.~   "
26367|NCT03221842|"~     This is a double-blind, randomized-withdrawal, placebo-controlled study in kidney transplant~     patients with AMR to evaluate the efficacy and safety of human plasma-derived C1-esterase~     inhibitor as add-on to standard of care (IVIG).~   "
26368|NCT03221829|"~     The aim of the study was to evaluate the safety and effectiveness of spinal anesthesia among~     elderly patients The basic methods for diagnosis and management of bladder cancer include~     endoscopic procedures (cystoscopy, trans-urethral resection of bladder tumour TURBT). The age~     of most patients is above 60, which increases the risk of complications during the~     perioperative period. Usually the leading anaesthesia method in TURBT procedures is regional,~     mainly spinal, anaesthesia. Although the prevalence of regional upon general anaesthesia is~     questioned, certain positive aspects of regional anaesthesia are indisputable. Maintaining~     logical communication with a patient during the procedure enables early diagnosis of~     complications (TUR syndrome, bladder perforation). Undeniably, regional anaesthesia ensures~     the best pain management in the early post-operative period. The simplicity of performing an~     efficacious spinal block and its cost-effectiveness are additional factors, which have~     contributed to the acknowledgement of the method as the standard of anaesthesia for~     transurethral procedures.~   "
26377|NCT03221712|"~     The aim of this study is to find strategy for treatment through comparing the cardiopulmonary~     exercise test parameters before and after cardiac rehabilitation in patients with chronic~     total occlusion of the coronary arteries.~   "
26378|NCT03221699|"~     Bothersome odor from the axilla is in most cases caused by Corynebacterium spp.~     Anti-microbial effects of zinc oxide (ZnO) are well documented.~      The overall objective of this study is to verify that repeated applications of a ZnO~     containing formulation can be directly linked to reduced growth of Corynebacterium spp. in~     the axillae.~   "
26379|NCT03221686|"~     Collagen synthesis is depressed systemically in the immediate postoperative period. Arginine,~     zinc and vitamin C impact collagen synthesis.~      The aim of this study is to investigate the effect of a pre and postoperative oral supplement~     consisting of arginine, zinc and vitamin C on collagen synthesis in patients undergoing~     inguinal hernia repair.~   "
26420|NCT03221153|"~     In this project, the authors aim to evaluate the use of high fidelity simulation as a method~     of evaluation of general skills in fifth year medical students about patient quality and~     safety in a hospital setting.~   "
26369|NCT03221816|"~     Introduction: Cardiovascular diseases (CVD) are the main cause of death in Western countries.~     High levels of homocysteine (He) has been considered an important risk factor for coronary~     artery disease. Objective: To evaluate the effects of the drug Tenavit® (pyridoxine~     hydrochloride 4.00mg + folic acid 0.80mg + cyanocobalamin 0.40 mg) on plasma homocysteine~     concentrations and lipid profile in postmenopausal women. Methods: Sixty women were~     postmenopausal selected from the outpatient Gynecology Hospital Santa Marcelina that passed~     by routine consultations and fulfilling the inclusion criteria were invited to the study. The~     women were randomly allocated to control or experimental group (30 in each group) in a do~     uble-blind controlled clinical trial. The experimental group received one tablet of Tenavit®~     daily and the placebo group received the same tablet with the organoleptic characteristics of~     Tenavit® for a period of 4 months. The women were assessed before the intervention and after~     4 months of medication. A self-report questionnaire to assess quality of life (QSF-36) was~     applied and anthropometric measurements, cholesterol and fractions, triglycerides, fasting~     glucose, homocysteine and cysteine were evaluated. Results: The only variable that presented~     significant alteration in both dimensions (between and within group) was the homocysteine. It~     was observed statistical significant between groups in the final measure for homocysteine~     (control group: 11.5mmol/ L; experimental group: 9.4 mmo~   "
26370|NCT03221803|"~     The purpose of this study aimed to answer a clinical question whether In a patient with~     bilateral distal extension area, would the metal framework partial denture with OT vertical~     attachment versus partial denture with OT CAP attachment result in better patient~     satisfaction?~   "
26371|NCT03221790|"~     OBJECTIVE: To gain mechanistic insights, we will compare effects of low fermentable~     oligosaccharides, disaccharides and monosaccharides and polyols (FODMAP) and high FODMAP~     diets on symptoms and colonic protease expression in patients with diarrhea predominant~     irritable bowel syndrome (IBS-D). We will measure how protease changes affect excitability of~     pain sensing neurons and correlate this with measurements of the metabolome and the~     microbiome.~      DESIGN: We aim to perform a single blind prospective study of patients with diarrhea~     predominant IBS (Rome IV criteria) who will sequentially consume a high and low FODMAP diets,~     each for 3 weeks. Symptoms will be assessed using the IBS symptom severity scoring (IBS-SSS).~     Electrophysiological studies of changes in mouse dorsal root ganglia neurons in response to~     colonic mucosal/lamina propria supernatants will be carried out. Protease antagonist will be~     used to specifically assess protease expression. The metabolome will be evaluated using~     metabolic profiling in urine using mass spectrometry. Stool microbiota composition will be~     analysed by 16S rRNA gene profiling. All the above testing will be performed at 4 time~     points: at baseline, 3 weeks following a run-in period, after a 3-week-long high FODMAP diet,~     and after a 3-week-long low FODMAP diet period.~      HYPOTHESIS: We anticipate that colonic tissue protease effects on the excitability of dorsal~     root ganglia (DRG) neurons will increase with a high FODMAP diet and decrease with a low~     FODMAP diet, but that this may not be found in all patients. The magnitude of the effect may~     vary and this variation could be due to differences in the individual patients microbiome.~   "
26372|NCT03221777|"~     Rationale Atrial fibrillation (AF) often occurs transiently in the setting of an acute~     stressor (e.g.~      medical illness or surgery). Uncertainty exists as to whether AF Occurring Transiently with~     Stress (AFOTS) is secondary to a reversible precipitant and is benign, or is a first~     presentation of paroxysmal AF and associated with a risk of stroke. AFOTS is a common~     occurrence (>40% in some intensive care settings), but there is a lack of evidence to guide~     its management and guidelines have called for further research in this area. Retrospective~     data suggest that many patients with AFOTS (>50%) will experience recurrent AF. These~     estimates were obtained without using sensitive methods for AF detection, which raises the~     possibility that the true rate of recurrent AF is much higher. As the rate of recurrent AF~     increases, it becomes increasingly likely that AFOTS is just the first detection of typical~     clinical AF.~      Objective To use a sensitive strategy to determine the rate of recurrent AF among patients~     who experienced AFOTS following i) non-cardiac surgery OR ii) medical illness, compared to~     matched controls.~      Methods Two multi-centre, 138-patient, observational cohorts. AFOTS patients will have new~     AF, documented by 12-Lead ECG or surface monitoring, during hospitalization for non- cardiac~     surgery (Cohort 1) or medical illness (Cohort 2).~      Controls will be patients without a history of AF who are matched for age (within 5 years),~     sex and exposure to stressor. Participants will wear a 14-day ECG monitor at 1 and 6 months~     after discharge. The endpoint is detection of AF.~      Impact~      If the incidence of AF after AFOTS is >80%, clinicians could be advised to treat AFOTS like~     clinical AF and initiate anticoagulation according to guidelines. Otherwise, a strategy of~     surveillance for AF would be advised.~      Hypothesis~        1. Patients who experience AFOTS will have a higher future incidence of AF and of stroke~          compared to patients exposed to a similar stressor but who did not develop AF.~        2. The risk of recurrent AF after AFOTS will be sufficiently high (> 80%) to warrant~          routine initiation of long-term OAC in all cases.~   "
26373|NCT03221764|"~     This study will prospectively evaluate the use of an amiodarone releasing hydrogel applied to~     the pulmonary veins and atria at the time of lung transplantation. This study will include~     patients undergoing lung transplantation at Jewish Hospital, Louisville KY. The prospective~     group will be compared to historical controls from the same institution. Investigators will~     access medical records and database entries for those patients undergoing lung~     transplantation after January 1st 2005 in order to obtain matched controls for analysis.~     Informed consent will be obtained from the prospective cohort prior to patient enrollment.~     This pilot study will be used to obtain preliminary data in order to proceed with a larger~     randomized control trial.~   "
26374|NCT03221751|"~     Mild traumatic brain injury (mTBI) from explosions is the signature injury of Veterans who~     have deployed to the wars in Afghanistan and Iraq. Although the immediate effects of a single~     mTBI usually resolve over days or weeks, multiple mTBIs can lead to both persistent symptoms~     and, years later, to two fatal progressive brain diseases, chronic traumatic encephalopathy~     (CTE) and Alzheimer's disease (AD). It is believed that CTE and AD are caused by nerve~     damaging chemicals called tau and beta amyloid produced by the brain but which are not~     removed from the brain in a normal manner in persons with mTBIs. The investigators will~     determine in Veterans who experienced mTBIs whether a clinically available drug called~     prazosin increases removal of tau and beta amyloid from the brain. This will be accomplished~     by seeing if prazosin reduces the amount of tau and beta amyloid in the spinal fluid that~     surrounds the brain. If the investigators find such reductions, prazosin will be evaluated as~     a preventative treatment for CTE and AD in future studies.~   "
26375|NCT03221738|"~     The investigators are developing and testing a Smartphone-based cognitive behavioral therapy~     (CBT) app for body dysmorphic disorder (BDD). The investigators hypothesize that app-based~     CBT for BDD will be feasible and acceptable to individuals with BDD, and will improve body~     image concerns and related outcomes.~   "
26376|NCT03221725|"~     Surgery for Stage II-III Pelvic organ prolapse~   "
26382|NCT03221647|"~     Background & Aims The enteropathy in Celiac Disease (CD) is due the adaptive and to the~     innate immune response to gliadin peptides. Gliadin peptide P31-43 activates innate immune~     response and interferes with vesicular trafficking. Type 1 interferons (INFs) and viral~     infections play a role in CD pathogenesis. In this paper investigators investigated the role~     of P31-43 in the activation of the INF-α pathway.~      Methods Small intestinal biopsies of CD patients both with active disease on gluten~     containing diet (GCD) and in remission phase of the disease on a gluten free diet (GFD) and~     controls were analyzed before and after culture with P31-43. The levels of toll like receptor~     7 (TLR7), myeloid differentiation primary response 88 (MyD88), myxovirus resistance protein 1~     (MxA) and nuclear factor-κB (NF-κB) proteins and INF-α mRNA was analyzed in intestinal~     biopsies.~   "
26383|NCT03221634|"~     The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) in~     combination with daratumumab in participants with relapsed refractory multiple myeloma~     (rrMM). The primary outcome measure for this study is the assessment of Objective Response~     Rate (ORR) in participants with rrMM.~   "
26384|NCT03221621|"~     The primary objective of this randomized controlled clinical trial in a real life setting is~     to evaluate the cost-utility of limumab monotherapy compared with the combination of~     adalimumab and a maximum of three surgeries after two years of treatment in adult patients~     with moderate to severe HS.~   "
26385|NCT03221608|"~     This multicentric study aims to determine if hyperthermic intraperitoneal chemotherapy~     (HIPEC) will help to prevent the development of peritoneal carcinomatosis in addition to the~     standard adjuvant systemic treatment after surgery.~   "
26386|NCT03221595|"~     This study evaluates the efficacy of surgical stabilization of rib fractures, as compared to~     best medical management, for patients with multiple, displaced rib fractures.~      Half of patients will be randomized to surgery (in addition to best medical management),~     whereas the other half will be randomized to medical therapy only.~      The primary outcome will be the subjects overall quality of life measured at two months~     following injury.~   "
26387|NCT03221582|"~     An evaluation of the impact of Elbasvir and Grazoprevir (EBR/GZR) HCV therapy on the heart~     risk and bone health of HCV mono-infected and HIV/HCV co-infected patients.~   "
26388|NCT03221569|"~     The study investigators are attempting to determine if ketamine can offer rapid, complete and~     sustained headache relief in the acute setting and 48 hrs post-discharge. The goal of this~     study is to enroll 40 patients total (20 per arm). This will be a double-dummy study in~     that there will be no placebo only arm. Medications will be administered in a double blind~     randomized fashion. Each patient will receive an intranasal solution via atomizer and a 50 cc~     IV normal saline bag. Arm A would include 1 mg/kg intranasal ketamine and a 50 cc normal~     saline IV bag while Arm B would receive placebo intranasal dose and 10 mg Metroclopramide/25~     mg Diphenahydramine mixed in 50 ccs normal saline. The primary endpoints are: Patient~     perception of pain as described by the use the Numerical Rating Scale (NRS) at 30 minutes.~      The secondary endpoints are: Frequency and mean dose of rescue/additional doses of therapy at~     30min, incidence of dissociative effects (characterized by hallucination, disorientation,~     confusion, agitation, delirium, dreams) during study period, Incidence of nausea, vomiting,~     or worsening headache, Incidence of bad taste, Incidence of burning sensations in the~     nostrils, Incidence of hypertension, Time to patient discharge from the initiation of study~     medication/placebo, patient satisfaction of pain control based on a Likert Scale.~   "
26389|NCT03221556|"~     This is a randomized comparative effectiveness trial to improve outcomes among pregnant and~     post-partum women with symptoms of depression. Both interventions under study will be based~     in the patient-centered medical home setting at Boston Medical Center - specifically, in~     prenatal clinic or in the general pediatrics clinic. The study is a type 1 hybrid~     effectiveness-implementation trial of 230 mothers with clinically significant depressive~     symptomatology. Of the 230 subjects, half will receive the Engagement-Focused Care~     Coordination intervention; the other half will receive the Problem Solving Education~     intervention. Outcomes for mothers will be assessed every 2 months throughout a 12 month~     follow-up period. This trial is funded by a contract with PCORI, the Patient-Centered~     Outcomes Research Institute.~   "
26390|NCT03221543|"~     This study evaluates if measuring resting metabolic rate (the number of calories the body~     burns at rest) before surgery can help predict successful weight loss after surgery.~   "
26391|NCT03221530|"~     The purpose of this project is to develop and test a family-based preventive intervention for~     suicide risk among 1st and 2nd generation immigrant Latino/a adolescents. The intervention~     will focus on reducing suicide risk by reducing family conflict and intergenerational~     cultural conflict and improving parent-child communication. The investigators will first~     develop the 8-session preventive intervention with quantitative data from analysis of~     existing longitudinal studies and qualitative feedback from Latino youth and their~     caregivers, clinicians, administrators, and research consultants, as well as results from~     initial pilot testing of the intervention. The investigators will then conduct a pilot~     randomized trial with 40 adolescents and their families to test feasibility, acceptability,~     and impact on intervention targets. Successful development of the intervention would improve~     mental health outcomes for a growing and underserved portion of the U.S. population.~   "
26392|NCT03221517|"~     The investigators hypothesize that disruptions to the microbiome of shift-workers represent a~     hitherto unexamined factor contributing to disease risk. The investigators will therefore~     define time-of-day dependent fluctuations of the microbiome in night shift workers and~     matched daytime workers deeply phenotyped for behavioral, clinical, and metabolomic outputs~     using integrated remote sensing.~   "
26393|NCT03221504|"~     The investigators aim to assess the effectiveness of a 7-day compared with a 10-day course of~     antibiotic treatment for febrile urinary tract infections (UTIs) in children. It is~     formulated a hypothesis that a 7-day course of antibiotic therapy is equally effective as a~     10-day course of therapy and would entail a lower risk of adverse events and better~     compliance.~   "
26394|NCT03221491|"~     In this study, the investigators investigated the efficacy, usefulness and analgesic~     consumption of three different patient-controlled analgesia(PCA) programmes:bolus dose alone~     without background infusion, bolus dose with low background infusion and bolus dose with high~     background infusion to evaluate postoperative analgesia for patients after laparoscopic~     colorectal surgery.~   "
26395|NCT03221478|"~     Objective: The general objective of this study is to determine the possible beneficial effect~     of the application of kinesiotaping, as well as the performance of proprioceptive exercises~     on parameters related to knee stability, such as the incidence of injuries, pain, static~     stability Or dynamics, and flexibility, in amateur soccer players, with a workload of 3 days~     per week plus the match.~      Material and methods: Amateur soccer players are divided into 3 groups.~      Group 1 (G1) performs proprioceptive exercises plus the application of kinesiotaping without~     tension in the knee.~      Group 2 (G2) performs proprioceptive exercises plus the application of kinesiotaping with~     tension in the knee.~      Group 3 (G3) is placed kinesiotaping with tension in the knee, without proprioception~     exercises.~      The treatment will last four weeks and three evaluations, one before treatment, another at~     two weeks and the last one at the end of treatment.~   "
26396|NCT03221465|"~     Project LIFT is a randomized, controlled trial that tests the effectiveness of a~     remotely-monitored, home-based exercise program utilizing wearable fitness trackers to~     monitor steps taken per day, health engagement questions, and financial incentives. 120~     subjects will be randomized into 3 arms: 1) usual care - no fitness tracker or incentive, 2)~     a fitness tracker + no incentives, and 3) fitness tracker plus financial incentives.~   "
26397|NCT03221452|"~     The aims of this project are: (1) to refine an existing cognitive rehabilitation intervention~     and tailor it for persons with T2DM by using current literature and interview data from 10~     participants with T2DM and (2) to conduct a feasibility study of the adapted intervention~     with 20 participants with T2DM. The intervention consists of 8 weekly group educational~     sessions to teach compensatory cognitive strategies. Participants will also use a web-based,~     game-like program to build on the didactic information and practice activities to improve~     cognitive health.~   "
26398|NCT03221439|"~     There is evidence, of a single randomized controlled trial, that CFT is better than combined~     manual therapy and motor control exercise for chronic low back pain. However, this study had~     significant methodological shortcomings regarding the failure to carry out the intention to~     treat analysis and a considerable loss of follow-up of patients. It is important to replicate~     this study through a randomized clinical trial with similar objectives in another domain, but~     correcting these methodological shortcomings. Therefore, the aim of the study is to assess~     the efficacy of Cognitive Functional Therapy in patients with chronic non specific low back~     pain.~   "
26399|NCT03221426|"~     The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in the~     neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated~     adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.~      The primary hypotheses of this study are that pembrolizumab plus chemotherapy is superior to~     placebo plus chemotherapy in terms of overall survival (OS), event-free survival (EFS) and~     pathological complete response (pathCR) rate.~   "
26400|NCT03221413|"~     The need for non-invasive, non-pharmacological and cost-effective therapeutic options has~     revived the use of transcranial current stimulation, either direct (tDCS) or alternating~     (tACS), in a wide range of pathologies and cognitive disturbances. Results, although often~     promising, are not unequivocal, possibly due to different stimulation parameters and sites,~     or non-homogenous patient selection. tDCS has been widely applied but few studies have~     focused on tACS which has the advantage of potentially entraining brain oscillations at the~     same frequency of stimulation. This overcomes the basic mechanism of tDCS which deploys~     anodal or cathodal currents to broadly excite or inhibit supposedly dysfunctional underlying~     cortex.~      Whether a stimulation paradigm based on sound neurophysiological markers could provide a~     better and longer-lasting clinical outcome has not yet been ascertained.~      The investigators aim to establish, with a trans-disease approach, categories characterized~     by defective EEG oscillatory activity and related dysfunctional networks. This~     classification, expected as the result of the first stage of this project, will guide the~     stimulation paradigm: categories with a pathologically low-band EEG prevalence will be~     treated with high-frequency tACS, and vice-versa, while the stimulation site will correspond~     to the defective sites of pathological EEG band maps. Parkinson's disease (PD), the EEG~     marker of which is a shift towards fast frequencies, and neuropathic pain (NP), with an EEG~     prevalence of slow bands, will be considered.~      In order to categorize pathologies on the basis of their EEG frequencies, EEG power spectrums~     will be derived from resting EEG, and cortical oscillatory reactivity will be assessed by~     EEG-TMS (electroencephalographic-Transcranial Magnetic Stimulation) co-registration. This~     method appears to elicit state-dependent brain oscillatory response and is expected to~     support power spectrum data. The identified prevailing EEG band will be used subsequently to~     reconstruct scalp EEG band distribution. tACS paradigms will be tailored according to these~     findings: the anode will be placed over the scalp area corresponding to the dysfunctional~     rhythm and frequency will be set in order to correct the prevailing EEG band (slow~     stimulation if fast frequencies prevail, and vice-versa).~      The translational element of this research proposal will consist of its clinical application~     in day-to-day practice for the benefit of people with the target conditions. The~     patient-groups, after undergoing the neurophysiology studies, will be tested with~     disease-specific scales and a neuropsychological battery. A 2-weeks tACS, either real or~     active sham, protocol will then be performed (30 minutes/day, 5 days/week), associated with~     an ad hoc rehabilitation protocol (60 minutes/day 5 days/week). During the last day of~     stimulation, patients will be tested again with the disease specific scales,~     neuropsychological battery and standard EEG to detect EEG frequencies modifications. At~     4-weeks follow up, the same tests and EEG recording will be carried out, to assess the~     persistence of after-effects.~      The expected result is a valid, non-invasive and cost-effective stimulation paradigm based on~     sound neurophysiologic markers which transcend traditional disease classifications.~   "
26401|NCT03221400|"~     Protocol PEN-866-001 is an open-label, multi-center, first-in-human Phase 1/2a study~     evaluating PEN-866 in patients with advanced solid malignancies whose disease has progressed~     after treatment with previous anticancer therapies.~   "
26402|NCT03221387|"~     Humidified Nasal High-flow with Oxygen (HNHF-O2) therapy has been reported to have acute~     beneficial effects in patients with hypoxemic respiratory failure who have been hospitalized.~     The usefulness of this therapy in the outpatient setting is unproven. This pilot study will~     test the feasibility of using this therapy in the outpatient setting and its effects on~     sleep.~   "
26403|NCT03221374|"~     Mind-Body Awareness Training (MBAT), in the forms of various yoga and meditative practices,~     has become increasingly prevalent due to an increase in awareness of the potential health~     benefits, and improvements in concentration that this training can provide to practitioners.~     In the present study, the role of Mind-Body Awareness Training (MBAT) in the initial learning~     of a sensorimotor (SMR) based Brain-Computer Interface (BCI) is being investigated. The~     hypothesis is that MBAT will improve performance in SMR based BCI.~   "
26404|NCT03221361|"~     In this research we are comparing the new thermoplastic material side by side with the~     conventional poly methyl methacrylate for fully edentulous patients measuring their maximum~     biting force whether it is going to be higher by the new polyamide material.~   "
26405|NCT03221348|"~     This is a single-arm open label trial to explore the tolerability, safety, PK, PD, and~     anti-tumor activity of various doses and schedules of CHO-H01 administered as monotherapy in~     subjects with follicular lymphoma.~      Groups of 6 subjects are planned for each cohort. The first 3 patients of each cohort will be~     evaluated to determine if it is appropriate to proceed with the additional 3 patients at that~     dose and schedule.~   "
26406|NCT03221335|"~     Radiofrequency ablation has been used for treatment of solid neoplasms of the liver, lung,~     kidney and adrenal. Recently, EUS-guided RFA has become available and the device allows~     EUS-guided treatment of solid abdominal neoplasms. The procedure has been shown to be~     feasible in the porcine pancreas and was used to treat small groups of patients that are not~     suitable for surgery suffering from pancreatic cancers.~      The aim of the current study is to perform a multi-center prospective study on EUS-guided~     radiofrequency ablation (RFA) of solid abdominal neoplasms. The hypothesis is that EUS-guided~     RFA is safe, feasible and effective for treating solid abdominal neoplasms.~   "
26407|NCT03221322|"~     Obesity is the 5th leading cause of global death, and is major risk factors for many chronic~     diseases, such as type 2 diabetes, cardiovascular diseases, hypertension and cancer. Obesity~     is caused by an imbalance between energy intake and energy expenditure, and it is widely~     agreed to be a consequence of a gene by environment interaction. Although on average obesity~     rates are increasing, the shape of the distribution of adiposity is changing: it is becoming~     more right skewed. This is because there is a population of very lean subjects that has~     remained almost unchanged by the epidemic. The investigators have called these very lean~     individuals that are resistant to the epidemic and sustain a BMI < 18.5 kg/m2 'super lean'~     subjects. We have very little understanding of the lifestyles of these individuals and how~     they are able to maintain their super lean phenotype, and whether the basis of their leanness~     is primarily genetics.~   "
26436|NCT03220945|"~     This randomized pilot trial studies the effect of comprehensive yoga program (SKY) in~     reducing stress, pain, and fatigue, and improving psychological well-being in patients with~     prostate cancer. SKY is one of the most widely used breathing techniques derived from yoga.~     SKY Yoga may improve quality of life in patients with prostate cancer.~   "
26408|NCT03221309|"~     This is an open label, non-randomized, observational pilot study to evaluate a model of care~     for treatment of hepatitis C in people with ongoing injection drug use. Participants will be~     treated with direct-acting antivirals (DAA) as per standard of care and will concomittantly~     be offered pre-exposure prophylaxis for HIV prevention and buprenorphine for treatment of~     opioid use disorder when clinically indicated.~   "
26409|NCT03221296|"~     A feasibility study of a vestibular rehabilitation program in a sample of cognitively~     impaired clinical patients to guide future trials.~   "
26410|NCT03221283|"~     The group music therapy will be used to treat female amphetamine-type stimulant (ATS)~     addiction~   "
26411|NCT03221270|"~     Investigating the effects of non-invasive transcranial alternating current stimulation (tACS)~     as a treatment for auditory hallucinations in patients with schizophrenia.~   "
26412|NCT03221257|"~     A Phase II multi-center, double-blind, parallel group, randomized and placebo-controlled~     clinical trial addressing the treatment of patients with active and symptomatic~     Scleroderma-related interstitial lung disease (SSc-ILD).~   "
26413|NCT03221244|"~     Problems with distraction are widespread in the 21st century, but for people with~     developmental delays or behavioral challenges they can have more damaging effects. For~     example, susceptibility to distraction is associated with worse school and social~     performance, lower high school graduation rates, and increased incidence of serious~     accidents. The investigators' goal is to improve understanding of distractibility and develop~     a targeted treatment. The proposed intervention is based on models of habituation, which is a~     term that means reduced physiological and emotional response to a stimulus (e.g. moving~     object, or loud noise, etc.) as it is seen repeatedly. The investigators use virtual reality~     technology to show study participants distracting stimuli repeatedly in a virtual classroom~     setting, and their hypothesis states that participants will improve attention in the face of~     distraction by training with this technology intervention. The virtual classroom setting is~     especially relevant for children who have significant challenges with distractibility, such~     as children with ADHD. This intervention will likely be effective in helping individuals with~     other clinical disorders and perhaps the general population as well.~   "
26414|NCT03221231|"~     We investigate the effects of repeated NAC administration on glutamate concentrations in the~     anterior cingulate cortex (ACC), on neurocognitive functioning, and on neuro-inflammatory~     parameters in adult cannabis-dependent individuals.~   "
26415|NCT03221218|"~     The study will examine whether enhancing screening-informed follow-up letters will improve~     (i) family physician compliance with best practice guidelines for managing persistent~     symptoms following concussion, and (ii) clinical outcomes from concussion.~   "
26416|NCT03221205|"~     This study evaluates the effect of the use of nasal CPAP in the cardiac function, measured by~     strain and TEI index, in patients with type 2 diabetes mellitus, obstructive sleep apnea and~     obesity. In order to do so, 76 patients will be studied, half will use sham CPAP and half~     will use therapeutic CPAP for three months, with ecocardiogram, laboratory studies,~     ambulatory monitoring of arterial tension and sleep study before and after CPAP use.~   "
26417|NCT03221192|"~     Nasal polyposis is a chronic inflammatory disease of the nose and sinuses. GlaxoSmithKline~     (GSK) is embarking on a clinical program to assess treatment of severe, recurrent nasal~     polyps with an anti-interleukin-5 (anti-IL5) (mepolizumab). Subject specific symptomatic~     endpoints will form the basis for the assessment of treatment benefit of nasal polyp~     therapies. However, there is a lack of published qualitative data regarding nasal polyps to~     understand the symptoms or health-related quality of life (HRQoL) impacts. This~     cross-sectional qualitative study aims to address this unmet gap by conducting~     semi-structured combined concept elicitation (CE) and cognitive debriefing (CD) telephone~     interviews and real-time data capture. The combined CE and CD interviews (each 90 minutes in~     duration) will investigate the subject experience of nasal polyps, and the relevance and~     understanding of existing patient-reported outcomes (PRO) instruments and the real-time data~     capture, over a 10 day period, will investigate the subject experience of the symptoms, HRQoL~     impacts and treatment of nasal polyps and any day-to-day variability that exists in these~     experiences in 'real time'. Twenty adult subjects in the United States (US), and 10 adult~     subjects in Germany with severe, recurrent nasal polyps will participate in the CE and CD~     interviews section of the study and of these, 10 subjects from US will also complete~     real-time data capture app task.~   "
26418|NCT03221179|"~     The primary objective of this study is to evaluate the safety and tolerability of single~     ascending doses of subcutaneous (SC) injections of RO7049665 in healthy volunteers. In~     addition, pharmacokinetics (PK) of RO7049665, the effects of single doses of RO7049665 on~     regulatory T-cells as well as the single dose immunogenicity of RO7049665 will be evaluated.~     This trial plans to evaluate approximately seven single dose-levels of RO7049665 or~     matching-placebo during dose-escalation in approximately 40 participants.~   "
26419|NCT03221166|"~     Crohn's disease (CD) is a life-long inflammatory bowel disease disease with an unknown~     pathogenesis. The ultimate goal of therapy is to modify the natural history of CD thus~     reducing complications. Thalidomide is a small molecule with immunomodulatory and~     anti-angiogenetic properties. It is currently approved for the treatment of erythema nodosum~     leprosum, an immunological complication of leprosy and multiple myeloma. It has also been~     used in several other inflammatory diseases of the skin and of the mucosal membranes, such as~     Behcet disease, oropharyngeal ulcers in AIDS, cutaneous lupus, and graft versus host disease.~     Many case series and one pediatric randomized controlled trial proved the efficacy of~     thalidomide in the treatment of children with CD refractory to standard treatments. In these~     patients, clinical remission was achieved in about 50% of the cases and was maintained for a~     mean time superior of 3 years. Mucosal healing after 52 weeks of treatment was observed in~     40% of the patients in clinical remission. Moreover, thalidomide was found to have a~     steroid-sparing effect and to decrease the need for surgical interventions. The clinical and~     endoscopic efficacy of thalidomide was also observed in children with failure to respond or~     intolerance to anti-TNF biological drugs.~      The aim of this multicentric prospective randomized controlled is to evaluate the efficacy~     and safety of thalidomide vs infliximab in changing the natural history of CD in patients~     with poor prognostic outcome. Moreover, the study will evaluate the immunological and~     genetical mechanisms of CD, the mechanisms of action thalidomide in CD and will the~     pharmacokinetics, metabolomics and pharmacogenomics of thalidomide, and their impact on~     thalidomide safety and effectiveness.~   "
26421|NCT03221140|"~     Outpatient parenteral antimicrobial therapy (OPAT) has been recognised as a useful,~     cost-effective and safe alternative to inpatient treatment, but no formal OPAT unit existed~     in Switzerland until recently. In December 2013 an OPAT unit was established at Lausanne~     University Hospital. The investigators plan to investigate the efficacy, safety and~     economicity of outpatient parenteral antimicrobial therapy administered at the new OPAT unit~     of the Lausanne University Hospital starting in January 2014 until December 2020.~   "
26422|NCT03221127|"~     To determine associations between dietary factors and risk of major chronic diseases and~     their risk factors~   "
26423|NCT03221114|"~     The largest epidemiologic study of Hispanic/Latino participants thus far, i.e., the Hispanic~     Community Health Study/Study of Latinos (HCHS/SOL) documented that 80% of men and 71% of~     women have at least one major cardiovascular disease (CVD) risk factor. The American Heart~     Association emphasizes that current CVD prevention efforts are sparse and ineffectual in~     minority populations and acknowledges the need for new and more effective disease prevention~     strategies. This observational study and pilot cluster-randomized clinical trial seeks to~     implement and evaluate a novel 8-week Positive Psychology (PP) Intervention (compared to an~     attention control condition) in Hispanic/Latino adults with uncontrolled hypertension, i.e.,~     elevated 24-hour ambulatory blood pressure, with primary interest in testing efficacy for~     clinically meaningful improvements in cardiovascular function.~   "
26424|NCT03221101|"~     Chronic Obstructive Pulmonary Disease (COPD) patients are more likely to develop acute~     hypercapnic respiratory failure. In the acute phase, non invasive ventilation has been shown~     to improve mortality and reduce intubation rate. Few studies are available about long term~     benefits of home non invasive ventilation in COPD patients with chronic hypercapnic~     respiratory failure who survived after an acute episode. The purpose of this study is to~     determine whether home non invasive ventilation can reduce recurrent acute hypercapnic~     respiratory failure in COPD patients who survived an acute hypercapnic respiratory failure~     episode treated by non invasive ventilation.~   "
26425|NCT03221088|"~     This study aims to explore the optimal dose of pegylated recombinant human growth hormone~     (PEG-rhGH) injection to treat children with idiopathic short stature (ISS), evaluate its~     safety and efficacy, and provide scientific and reliable evidence for the medication dosage~     in Phase III clinical study.~   "
26426|NCT03221075|"~     In order to determine the efficacy of antifungal therapy in patients with documented~     azole-resistant invasive Aspergillosis (IA), anonymized clinical information of patients with~     a hematological malignancy with a culture-positive invasive fungal infection caused by~     Aspergillus fumigatus are collected in an online registry. Respective fungal isolates are~     analysed for azole susceptibility and resistance mechanisms. Patients diagnosed with an IA in~     2016 and later are included in the study.~   "
26427|NCT03221062|"~     The traditional method of choice for intravesical resection of bladder tumors is conventional~     transurethral resection of bladder tumor (cTURBT). However, there has long been an ambition~     to overcome its biggest limitation, tumor fragmentation. Possible consequences include cell~     seeding and poor specimen quality, including missing detrusor muscle, thermal tissue damage,~     and tissue fragmentation. En bloc resection of bladder tumor (ERBT) represents an alternative~     technique for resection of bladder tumors. There is no doubt that ERBT has huge potential.~     ERBT provides specimens of high quality that are easy for pathologists to read. In theory,~     this may sustainably change the view on secondary resection, lead to faster decisions on~     subsequent treatments, and influence patient prognosis. Thus, there is an urgent need to~     compare ERBT with cTURBT in a thoroughly planned trial.~   "
26428|NCT03221049|"~     Liver diseases are worldwide problems. liver fibrosis and hepatocellular carcinoma are mostly~     concerned by clinicians. Radiomcis can improve diagnosis accuracy and evaluate disease~     progression. Hence,investors try to combine radiomics and ultrasound images together in order~     to improve diagnosis performances of liver fibrosis, benign and malignant tumor and~     progression after liver ablations.~   "
26429|NCT03221036|"~     The purpose of this study is to assess the effect of vedolizumab intravenous IV as induction~     and maintenance treatment in Chinese participants with moderately to severely active~     ulcerative colitis (UC).~   "
26430|NCT03221023|"~     The implantable pulse generator (IPG) is a device that generates electrical current to~     stimulate the spine, heart, or brain for various chronic conditions. In neurosurgery, the IPG~     is implanted in a subcutaneous pocket under the collarbone. This pocket is highly avascular~     and thus, antibiotics administered intravenously cannot reach a potential surgical site~     infection (SSI). SSIs cause millions of health care dollars to be wasted due to repeat~     surgery and hospital re-admissions. We hope to to determine the effects of intrawound~     vancomycin-saline and IV antibiotics compared to saline and IV antibiotics on the~     incidence of IPG SSI rates 6-months post-surgery.~   "
26431|NCT03221010|"~     The objective of this study is to evaluate the efficacy of Motivational Interview (MI) on the~     smoking cessation rates of the smoking groups performed by the primary care teams of the~     Conceição Hospitalar Group, Porto Alegre, Brasil, and also whether there is an increase in~     the completion rate of the groups.~   "
26432|NCT03220997|"~     The primary aim of this randomised control trial is to assess the impact of pre-operative~     carbohydrate loading on the incidence of urinary ketone bodies when compared to standard care~     in elective caesarean section. Half of the participants will receive pre-operative~     carbohydrates and the other half will receive standard care.~   "
26433|NCT03220984|"~     This study aims to evaluate the safety and efficacy of Immuncell-LC, the adoptive~     immuntherapeutic agent composed of a CIK cell agent, to treat patients with metastatic~     colorectal cancer, which are refractory to the 3rd-line chemotherapeutic agents.~      All enrolled patients received the 12 times of Immuncell-LC therapy: 8 times in every 1 week~     and 4 times in every 2 weeks.~   "
26434|NCT03220971|"~     Theranostic translation applications against viral, metabolic liver diseases and hepatic~     oncogenesis: lipoprotein and apolipoproteins at a crossroad~   "
26435|NCT03220958|"~     Nearly 1.5 million patients present to US emergency departments annually following head~     trauma. Headache is a frequent symptom of victims of head trauma. The purpose of this study~     is to see if an intravenous medication called metoclopramide can improve the symptoms of~     patients with acute post-traumatic headache.~   "
26437|NCT03220932|"~     With 4,600 new cases in France in 2012, ovarian cancer is the seventh most common cancer in~     women and the fourth cause of mortality by cancer. Despite a high response rate to initial~     treatment, most patients will relapse within 2 years. No standard treatment has yet been~     established for patients with recurrent ovarian cancer.~      Most patients with such recurrences are currently treated with new combinations of systemic~     chemotherapy. A repeated laparotomy with complete cytoreduction is also an option that~     several authors have used to obtain median survival rates of more than 30 months.~      Twenty five percent of patients experiencing relapse present with platinum-resistant~     recurrence, occurring less than 6 months after chemotherapy completion. Recently, Pujade et~     al. showed that adding bevacizumab to chemotherapy significantly improves progression-free~     survival (PFS) in this subgroup of patients with poor prognoses (16.6 months versus 13.3~     months in women treated with chemotherapy alone). Three case control studies have compared~     systemic chemotherapy and CRS (Cytoreduction Surgery) alone versus CRS plus HIPEC in patients~     with recurrent disease. They showed significantly improved results with the addition of~     HIPEC. In the French registry that included 474 patients with recurrence and peritoneal~     carcinomatosis, the median PFS was 13.8 months for platinum-resistant patients and 13 months~     for platinum-sensitive patients. Our hypothesis is that surgery would reduce the tumor burden~     and consequently the number of platinum-resistant tumor clones and that HIPEC would control~     the microscopic residual disease by increasing the tumor cell cytotoxicity.~      We assume that adding a locoregional treatment to an Aurelia-like systemic treatment would~     improve the PFS. We aim to assess the benefit of adding surgery and HIPEC to the treatment of~     first or second platinum-resistant recurrence compared to chemotherapy + bevacizumab.~   "
26438|NCT03220919|"~     The investigators propose to use a weight-based regimen consisting of basal-bolus insulin and~     preprandial rapid-acting insulin and to test its efficacy and safety in controlling blood~     glucose in hospitalized patients with type 2 diabetes.~   "
26439|NCT03220906|"~     There is very little information comparing non-invasive blood pressure (BP) readings obtained~     from upper and lower limbs, as well as comparing invasive and non-invasive blood pressures in~     the children under anesthesia. This study seeks to determine the correlation between the~     non-invasive BP measurements between upper and lower extremities and compare these~     measurements with the invasive BP as the standard for comparison.~   "
26440|NCT03220893|"~     The significance of this study is that it will be the first prospective trial to compare MBI,~     a relatively low-cost functional breast imaging technique, to DBT, the new standard anatomic~     breast cancer screening technique in women with dense breasts. This study is also the first~     to evaluate two consecutive annual MBI scans to assess change in advanced cancer presentation~     after introduction of a functional imaging technique. These data will inform individualized~     decisions on supplemental screening and determine if a functional technique that is~     relatively low in cost and complexity of interpretation can eliminate the reservoir of~     clinically important breast cancers that remain occult on anatomic techniques. This study~     will also provide exploratory data about the optimal frequency of repeat MBI.~   "
26441|NCT03220880|"~     Specific Aim 1: To describe the adequacy of sedation associated with different regimens of IN~     DEX in children undergoing non-painful procedures. This aim will test the working hypothesis~     that IN DEX regimens are effective for producing sedation adequate for completion of~     non-painful procedures in children.~      Specific Aim 2: To describe the temporal characteristics associated with varied regimens of~     IN DEX in children undergoing non-painful procedures, such as time to onset of adequate~     sedation; time to procedure start; and time from procedure end to meeting discharge criteria.~     This aim will test the working hypothesis that IN DEX regimens have temporal characteristics~     that are favourable for sedating children for non-painful procedures.~      Specific Aim 3: To describe the adverse events associated with varied regimens of IN DEX in~     children undergoing non-painful procedures. This aim will test the working hypothesis that IN~     DEX regimens have a low incidence of adverse events.~   "
26442|NCT03220867|"~     The primary purpose of this study is to assess the bioequivalence of Xian Risperdal compared~     with Gurabo Risperdal in Chinese healthy participants under fasting and fed conditions.~   "
26443|NCT03220854|"~     To determine if SRT and PD-1/PD-L1 inhibiting therapy can restore the benefit of PD-1/PD-L1~     inhibiting therapy in patients with an advanced solid tumor who had clinical benefit from~     PD-1/PD-L1 inhibiting therapy prior to progression.~   "
26444|NCT03220841|"~     Two thirds of patients with Crohn's disease require intestinal surgery at some time in their~     life. Intestinal strictures, that is narrowing of the bowel due to inflammation and scarring,~     are the most common reason for surgery. Despite the high frequency, associated disability,~     and cost there are no are no treatment strategies that aim to improve the outcome of this~     disease complication. The STRIDENT (stricture definition and treatment) studies aim to~     develop such strategies.~   "
26445|NCT03220828|"~     Preprocedural, preoperative, and prevascular access anxiety in pediatric patients has been~     previously shown to increase the likelihood of family stressors, postoperative pain,~     agitation, sleep disturbances, and negative behavioral changes. The purpose of this study is~     to determine if a non-invasive distracting devices (Virtual Reality headset, Augmented~     Reality headset, tablet, or bed mounted Video Projection unit (i.e. BERT, Bedside~     EnterRtainment Theater)) is more effective than the standard of care (i.e., no technology~     based distraction) for preventing anxiety before vascular access among hospitalized children~     undergoing vascular access prior to anesthesia, procedures, surgery, blood draws, port~     access, or peripheral IV placement. The anticipated primary outcome will be reduction of~     child's anxiety during and after vascular access.~   "
26446|NCT03220815|"~     20 patients were selected requiring implant placement and divided randomly into two groups~     (10 in each group)~        -  for the study group, starter drill is used to locate the point of insertion as planned~          then pilot drill is also used to the full desired working length after that all other~          sequential drills are used at a low speed (50-70 rpm) without irrigation .~        -  In the study group: implant will be inserted in the low speed osteotomy site. • In the~          control group: implants will be inserted in the conventional prepared osteotomy site.~        -  For both groups there is no surgical guide used.~        -  The flap will then be copiously irrigated with saline in preparation for closure.~        -  The flap will then be closed using interrupted 4/0 resorbable sutures.~   "
26447|NCT03220802|"~     Long-term proton pump inhibitor use has been linked to intestinal dysbiosis, inflammation and~     gastrointestinal symptoms. Probiotics has been shown to correct dysbiosis, reduce~     inflammation and strengthen the gut barrier. The aim of this study is to evaluate the~     influence of a three months intervention with a probiotic on intestinal inflammation, bowel~     symptoms, dysbiosis and gut permeability.~   "
26461|NCT03220620|"~     The objective of the study is to evaluate influence of perioperative fluid therapy on~     Methemoglobin levels, and to changes in hemoglobin. Further, changes in Methemoglobin will be~     related to metabolic signs of oxidative stress (changes in blood lactate). Patients~     undergoing major abdominal surgery will be included into the study.~   "
26448|NCT03220789|"~     20 patients were selected requiring implant placement and divided randomly into two groups~     (10 in each group)~        -  for the study group, starter drill is used to locate the point of insertion as planned~          then pilot drill is also used to the full desired working length after that all other~          sequential drills are used at a low speed (50-70 rpm) without irrigation .~        -  In the study group: implant will be inserted in the low speed osteotomy site.~        -  In the control group: implants will be inserted in the conventional prepared osteotomy~          site.~        -  For both groups there is no surgical guide used.~        -  The flap will then be copiously irrigated with saline in preparation for closure.~        -  The flap will then be closed using interrupted 4/0 resorbable sutures.~   "
26449|NCT03220776|"~     The proposed 3-week, double-blind, crossover, proof of concept study aims to manipulate~     neurochemical dysfunctions characteristic of individuals with co-occurring BD and AUD (i.e.,~     abnormally low prefrontal GABA and glutamate), using medications that have been shown to~     normalize cortical GABA (i.e., gabapentin) and glutamate (i.e., NAC) levels in past research,~     and to evaluate medication-related changes in response inhibition and alcohol cue-reactivity~     fMRI tasks as well as drinking and mood in individuals with AUD+BD.~   "
26450|NCT03220763|"~     The proposed study will test the hypothesis that frequency of eating away from home meals is~     independently related to the prospective risk of mortality in the US population. The study~     will use public-domain mortality linked data from US national Surveys to address this~     question.~   "
26451|NCT03220750|"~     The University Hospital Advanced Age Pregnant (UNIHOPE) Cohort is the major part of the~     National Key Research and Development Program on Reproductive Health & Major Birth Defects~     Control and Prevention Project, which is funded by the Ministry of Science and Technology of~     China. The Project is led by Prof. Zhao Yangyu, from the Department of Gynecology &~     Obstetrics, Peking University Third Hospital, and the UNIHOPE cohort is led by Prof.~     Jian-meng Liu, the Co-PI of the Project.~   "
26452|NCT03220737|"~     VAXCHORA (Cholera Vaccine, Live, Oral) is a vaccine indicated for active immunization against~     disease caused by Vibrio cholerae serogroup O1. VAXCHORA is approved for use in adults 18~     through 64 years of age travelling to cholera-affected areas. The primary goals of this Phase~     4 study is to evaluate the safety and immunogenicity of VAXCHORA in children ages 2 years to~     <18 years of age in developed countries.~   "
26453|NCT03220724|"~     The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of~     EnvSeq-1 Envs adjuvanted with GLA-SE, administered with or without DNA Mosaic-Tre env, in~     healthy, HIV-uninfected adults.~   "
26454|NCT03220711|"~     The overall aim of this research project is to evaluate the imaging performance of a confocal~     endomicroscope. Fluorescein, an FDA-approved topical fluorescent dye, will be used to provide~     topical mucosal contrast. The purpose of this instrument is to provide real-time endoscopic~     histology to guide endoscopic biopsy or endoscopic mucosal resection (EMR) in the patient~     study group. This endomicroscope probe will be used during colonoscopies in subjects with~     colonic dysplasia, known colonic adenomatous polyps scheduled for endoscopic resection, or~     suspected dysplasia in subjects with Inflammatory Bowel Disease (IBD).~   "
26455|NCT03220698|"~     The aim of this study is to compare tracheal ultrasound with direct visualization of tracheal~     rings for the confirmation of endotracheal tube placement in intubated patients. We~     hypothesize that this method is more reliable, cheap, and readily available for all emergency~     physicians.~   "
26456|NCT03220685|"~     The human intestinal tract harbours a diverse and complex microbial community which plays a~     central role in human health. It has been estimated that our gut contains in the range of~     1000 bacterial species and 100-fold more genes than are found in the human genome . This~     community is commonly referred to as our hidden metabolic 'organ' due to their immense impact~     on human wellbeing, including host metabolism, physiology, nutrition and immune function. It~     is now apparent that our gut microbiome coevolves with us and that changes to this population~     can have major consequences, both beneficial and harmful, for human health. Indeed, it has~     been suggested that disruption of the gut microbiota (or dysbiosis) can be significant with~     respect to pathological intestinal conditions such as obesity and malnutritio, systematic~     diseases such as diabetes and chronic inflammatory diseases such as inflammatory bowel~     disease (IBD), encompassing ulcerative colitis (UC) and Crohn's disease (CD) .~      The role of the gut microbiome in human health and disease is becoming clearer thanks to high~     throughput sequencing technologies (HTS) as well as parallel recent developments in non~     genomic techniques.~   "
26457|NCT03220672|"~     The goal of the present study is to evaluate the short and long term effectiveness of a~     tailored assessment and educational intervention on motor control of the pelvic floor muscle~     in menopausal and non-menopausal women.~   "
26458|NCT03220659|"~     Recently, the introduction of quadripolar left ventricular leads (one with four pacing poles)~     has allowed the opportunity to pace the lateral (back) of the heart from several points at~     once using a single lead (multi-point pacing - MPP). Although it seems logical that~     electrical beginning at several points on the left ventricular wall should improve~     coordination of the heart, there is no consistent response in terms of improved remodeling~     (cardiac structure and function) or composite scores of patient-related status. The~     technology has a further disadvantage that it leads to accelerated battery drain, with on~     average one year less longevity over the lifetime of the device.~      Aims are:~        1. to explore the effect of MPP on the force-frequency relationship,~        2. to examine the effects of MPP on exercise capacity measured by treadmill walk time and~          whether these are related to the FFR response to MPP in individual patients,~        3. establish whether the acute contractile response is maintained to 6 months after the~          implant procedure and~        4. determine whether the acute contractile response to MPP is associated with subsequent~          beneficial remodeling over a further six months.~   "
26459|NCT03220646|"~     The purpose of this study is to test any good and bad effects of a study drug called~     abemaciclib (LY2835219) in patients with recurrent brain tumors.~   "
26460|NCT03220633|"~     A double-blind, placebo-controlled, phase I study to assess safety, tolerability and~     pharmacokinetics of single/multiple ascending doses of atb-346 orally administered in healthy~     male and female subjects.~   "
26462|NCT03220607|"~     To evaluate the performance of uterocervical angle (UCA) in the prediction of second~     trimester terminations.~   "
26463|NCT03220594|"~     To observe the effects of hypogastric artery ligation on serum antimullerian hormone levels.~   "
26464|NCT03220581|"~     The fifth edition of the Diagnostic and Statistical Manual for Mental Disorders (DSM-5)~     introduces Internet Gaming disorder (IGD) as a Substance-Related and Addictive Disorder in~     Section 3, Conditions for Further Study. Although research is in the nascent stages, existing~     studies demonstrate that IGD is associated with psychosocial distress including suicidality,~     and adverse vocational and educational outcomes in youth. Internet gaming disorder also~     shares substantial overlap with substance use, and it primarily affects adolescents, who~     rarely seek treatment on their own. Parents more often express concerns about their child's~     game playing behaviors, and data suggest that parents can have strong influences on it. This~     psychotherapy development study will evaluate feasibility, acceptability, and effect sizes of~     a behavioral intervention designed to help parents reduce gaming problems in their children.~     Sixty concerned parents and their children will complete parental and self-report inventories~     and structured diagnostic interviews regarding the child's gaming behaviors, substance use~     and psychosocial functioning. Participants will be randomized to either a control condition~     consisting of referral for mental health issues and family support services or to the same~     plus a 6-week family-based behavioral intervention designed to assist with better monitoring~     and regulating the child's game playing behaviors and encouraging and rewarding alternatives~     to game playing. Gaming and other problems will be assessed pre-treatment, mid-treatment, at~     the end of treatment, and at a 4-month follow-up. This study is unique in evaluating initial~     psychometric properties of a parental version of a measure that uses the DSM-5 criteria for~     IGD in a clinical sample, and it will also assess associations of IGD with substance use,~     psychological symptoms, and family functioning over time. Most importantly, this study will~     be the first randomized trial of an intervention designed to reduce gambling problems, and~     results are likely to guide future research and treatment efforts related to this condition.~   "
26465|NCT03220568|"~     Background: Although low-fat dairy products are an integral part of a diet recommended for~     stroke prevention, the role of dairy fat in relation to the risk of stroke is not yet clear.~      Objective: Therefore the association of adipose tissue content of fatty acids, for which~     dairy products are a major source (12:0, 14:0, 14:1 cis-9, 15:0, 17:0, 18:1 trans-11 and 18:2~     cis-9, trans-11), with incident total stroke and stroke subtypes will be investigated.~      Design: The study is a case-cohort study nested within the Danish Diet, Cancer and Health~     cohort, including all incident stroke cases and a random sample of the total cohort.The fatty~     acid composition of adipose tissue biopsies was determined by gas chromatography and the~     content of specific fatty acids was expressed as percentage of total fatty acids. Stroke~     cases were identified in the Danish National Patient Registry and the diagnoses were~     individually verified. Cox proportional hazard regression will be used to estimate the~     association between fatty acids and stroke.~   "
26466|NCT03220555|"~     In vaccination centers, venipunctures and vaccinations are sources of pain and anxiety in~     pediatric patients. Prior painful experiences can reduce the acceptance of later health care,~     hence making it more difficult for both patients and nurses.~      The topical anesthetic cream (lidocaine, prilocaine) and the non-pharmacological (distraction~     and relaxation) interventions which are usually used for prevention of procedural pain impose~     certain constraints on families and on vaccination centers.~      A distraction and local anesthesia (cold and vibration) based medical device (Buzzy®) could~     overcome these constraints and could be an interesting alternative for healthcare management~     in vaccination centers and, in a broader perspective, in other medical services.~      Research on this device has been scarce to date. Three of them have shown an efficacy of~     Buzzy® in comparison to the absence of prevention of vaccination and venipuncture induced~     pain. An ongoing study will assess the Buzzy® device in comparison to a topical anesthetic~     cream, but will be set in an emergency department context. To date, no study has compared~     Buzzy® to topical anesthetic cream on healthy children in a vaccination center.~      The research team has formulated the following hypothesis: the Buzzy® device will allow to~     get a not lower or an equivalent level of pain compared to the level of pain obtained with~     the usual topical anesthetic cream. The aim of this study is to evaluate the efficacy of the~     device Buzzy® on vaccination and venipuncture induced pain in a vaccination center.~   "
26467|NCT03220542|"~     In Korea, the first-line therapy to treat Helicobacter pylori (Hp) consists of a proton pump~     inhibitor (PPI) and two antibiotics for one week. But, eradication has become less successful~     due to low compliance and high resistance to the antibiotics. Therefore, it is necessary to~     develop new treatment strategies that increase the eradication rate and reduce adverse~     effects. In vitro study, we previously reported that a broccoli sprout extract containing~     sulforaphane may prevent lipid peroxidation in the gastric mucosa and play a cytoprotective~     role in Hp-induced gastritis. Also, several studies suggested that probiotics could be~     effective for improving Hp eradication rate or reducing adverse events. But, their effect for~     eradication of Hp is not yet conclusive. The aims of this prospective study is to investigate~     the efficacy of a broccoli sprout extract containing sulforaphane and probiotics for~     eradication of Hp, compared with standard triple therapy.~   "
26468|NCT03220529|"~     The purpose of this research study is to find out if the new Brillouin Ocular Scanner can~     measure the variation (difference) of the corneal elastic changes involved in the onset of~     corneal ectasia, induced by LASIK surgery and cornea collagen crosslinking (CXL) treatment.~     Ectasia refers to the thinning and bulging of the cornea and results in severe vision~     degradation (loss), which may occur because of a progressive disease (keratoconus) or because~     of LASIK surgery. It is believed that the structural weakening of the cornea plays a major~     role in developing ectasia. CXL is a treatment that is able to halt the progression of~     ectasia.~      The Brillouin Ocular Scanner is a technique based on the principles used in the laser speed~     measuring of a car (radar gun). When laser light illuminates a moving sample, a portion of~     the light slightly changes color. In our body, e.g in eye and corneal tissue, very weak sound~     waves are naturally present and they can induce a similar color shift. Measuring this color~     shift with a sensitive light color meter (spectrometer), we will measure the sound speed in~     the tissue.~   "
26469|NCT03220516|"~     The aim of this trial is to compare the safety, efficacy and cost effectiveness of the three~     types of scopes.~   "
26470|NCT03220503|"~     Research Question:~      In women undergoing frozen embryo transfer, does routine endometrial injury before frozen~     embryo transfer increase clinical pregnancy rate?~      Research Hypothesis:~      (Null Hypothesis) In women undergoing frozen embryo transfer Routine endometrial injury~     before frozen embryo transfer does not increase clinical pregnancy rate.~      (Alternative Hypothesis) In women undergoing frozen embryo transfer, endometrial injury~     before the transfer may increase pregnancy rate.~   "
26471|NCT03220490|"~     According to the American Academy of Ophthalmology's Preferred Practice Pattern on Primary~     Open Angle Glaucoma, patients should wait five minutes between administering topical drops~     for intra-ocular pressure reduction.~      To date, no study has shown the efficacy of this waiting period. In this study, we aim to~     establish the clinical significance of keeping a time interval between glaucoma medications.~   "
26472|NCT03220477|"~     The purpose of this study is to test the safety of a combination of three drugs,~     pembrolizumab, guadecitabine and mocetinostat. Pembrolizumab is a drug given by vein and all~     patients will receive the same dose. Guadecitabine and mocetinostat will be given at~     different doses to find out what effects, if any, they have on treating your cancer and side~     effects.~   "
26473|NCT03220464|"~     The aim of this study is to evaluate ultra low dose chest computed tomography (ULDCT) for~     early diagnosis of active tuberculosis in cohort of close contacts of active pulmonary~     tuberculosis for 1 year follow up~   "
26474|NCT03220451|"~     All patients with a significant deficiency of skin sensitivity and reduced mobility are~     potentially at risk of Pressure Ulcers (PUs), in particular the persons affected by Spinal~     Cord Injury (SCI), also due to their frequent alteration or loss of subcutaneous skin~     sensitivity. Pressure sores are one of the most common and fearful complications in SCI, with~     a severe impact on quality of life and on care health costs. They are often the cause of~     lengthening the time of hospitalization, slowing down clinical and rehabilitation programs~     and re-hospitalization.~      PUs, when arisen, heal slowly and, despite the protracted conservative medical therapies,~     sometimes they do not come to complete healing. Sometimes plastic surgery is needed, although~     even after it recurrence rates remain high.~      Further treatments have been proposed in addition to the usual medication, however they are~     characterized by a certain degree of invasiveness and are often conditioned by the~     availability of specific and sometimes expensive equipment, as well as by the presence of~     highly qualified personnel. In general, there is also a lack of good quality clinical trials~     for assessing their effectiveness and safety and they are often not decisive, especially for~     severe and recalcitrant ulcers.~      Among alternative techniques for the healing of skin ulcers in general, the adhesive elastic~     bandage, also known as kinesio taping and already recognized for the treatment of edema,~     hematoma and scarring, has been proposed. However, specific protocols and published studies~     are not available for PUs.~      The Montecatone Rehabilitation Institute, that hosts the largest Spinal Unit in Italy, pays~     great attention to the prevention and treatment of PUs in both acute and chronic patients.~     The rationale for the taping positioning around PUs investigated in this study is to improve~     lymphatic drainage and reactivation of the superficial bloodstream by increasing interstitial~     spaces and reducing skin and subcutaneous compression, notoriously compromised in the areas~     of onset of pressure sores. The total shortage in the literature and in user manuals of~     taping protocols for PUs supports this preliminary, exploratory, descriptive and uncontrolled~     pilot study with the primary aim of verifying the safety of a taping treatment for~     medium/severe grade PUs, add-on to the usual care. The choice of the ulcer sites selected~     (sacral and heel) has been affected by the feasibility of tape positioning.~   "
26475|NCT03220438|"~     The major goal is to determine if Transcranial magnetic stimulation (TMS) enhances visual~     plasticity in schizophrenia. TMS sessions (sham/placebo and real TMS) will be conducted~     before two MRI scans with two weeks in-between to assess whether TMS stimulation to the~     visual cortex will enhance visual plasticity in patients with schizophrenia-spectrum~     disorders. This project may provide a better understanding of the underlying neurobiological~     mechanisms responsible for learning and memory deficits in schizophrenia.~   "
26476|NCT03220425|"~     The aim of this trial is to evaluate the efficacy and safety of insulin detemir using the~     2400 nmol/mL formulation to optimise dosing in subjects with type 1 diabetes on a basal (once~     daily)-bolus regimen.~   "
26477|NCT03220412|"~     More American children die by accidental gun use than children in other developed countries.~     One factor that can influence children's interest in guns is exposure to media containing~     guns. The objective of this study is to test whether children who see a movie containing guns~     will handle a real gun longer and will pull the trigger more times than children who see the~     same movie without guns.~   "
26478|NCT03220399|"~     The purpose of this study is to compare the pharmacokinetics and safety/tolerability between~     NVP-1603-1 and NVP-1603-2~   "
26479|NCT03220386|"~     The study EPICS-6 consists of three study phases. Emergency Department patients are screened~     for nasal and pharyngeal colonisation with Methicillin sensitive and Methicillin resistant~     Staphylococcus aureus (MSSA/MRSA) using a point-of-care (POC)-PCR-testing method~     (cobas®LIAT®-System, Roche Molecular Systems Inc.) The first aim of this study is to describe~     the prevalence of MSSA/MRSA-colonisation in a routine cohort of Emergency Department~     patients. The second aim is to determine the impact of POC-guided decolonisation as compared~     to conventional laboratory testing on in-hospital infection rates with MSSA/MRSA in a~     pre-post-comparison study.~   "
26480|NCT03220373|"~     The aim of this project is to gain a more specific understanding of how different cognitive~     profiles predict residential treatment drop-out, treatment retention and post-treatment~     outcome in a population with Substance Use Disorder.~   "
26481|NCT03220360|"~     To compare the efficacies of MTA, calcium hydroxide preparation, Biodentine and TheraCal LC~     that are commonly used in pediatric dentistry in the preservation of vital pulp in carious~     deciduous teeth.~   "
26482|NCT03220347|"~     Study CC-90010-ST-001 is an open-label, Phase 1a, dose escalation and expansion,~     First-in-human (FIH) clinical study of CC-90010 in subjects with advanced or unresectable~     solid tumors and relapsed and/or refractory advanced Non-Hodgkin's lymphoma (NHL). The dose~     escalation part (Part A) of the study will explore escalating oral doses of CC-90010 to~     estimate the maximum tolerated dose (MTD) of CC-90010. The expansion part (Part B) will~     further evaluate the safety and efficacy of CC-90010 administered at or below the MTD in~     selected expansion cohorts of approximately 20 evaluable subjects each in order to further~     define the recommended Phase 2 (RP2D) dose of CC-90010.~   "
26483|NCT03220334|"~     In Korea, where the prevalence of gastric tumors is high, the use of ESD as a treatment for~     gastric cancer will continue to increase. Considering that there are no special measures to~     prevent side effects (bleeding, perforation, etc.) of this procedure, it is possible to~     reduce the large medical costs through the discovery of substances that can promote gastric~     mucosal healing. Mechanism of PRP-based materials in the regeneration of gastric mucosal~     damage can be used to understand the pathophysiology of ulcers. In the future, it can be~     suggested as a new treatment for gastrointestinal tract damage such as intractable ulcer,~     perforation, mucosal fistula, gastrointestinal bleeding caused by esophagus, small intestine~     and large intestine as well as ulcer treatment by endoscopic procedure.~   "
26484|NCT03220321|"~     The aim of this study is to evaluate the effect of polymer-infiltrated-ceramic-network hybrid~     ceramic on pink and white esthetics in comparison with lithium disilicate.~      The research hypothesis is that there will be comparable clinical performance results between~     polymer-infiltrated-ceramic-network and lithium disilicate hybrid abutment crowns.~   "
26485|NCT03220308|"~     This study evaluates the effectiveness of an 8-week mindfulness group training for children~     (8-16 years old) with ADHD in combination with a parallel mindful parenting training for~     their parents. Half of the participants will be randomly assigned to the mindfulness training~     in addition to care-as-usual (CAU); the other half to CAU-only.~      The hypothesis is that compared to care-as-usual only, the addition of the mindfulness~     training will improve self-control of youth with ADHD.~   "
26487|NCT03220282|"~     Late preterm infants, who are born at 34, 35 or 36 weeks gestation, often have difficulty~     feeding, establishing growth, and fighting off infection. Breastfeeding provides improved~     nutrition to help fight infection, in part because breast milk encourages the growth of~     healthy bacteria (microbiota) in the infant's intestine. However, when mothers give birth~     preterm, their breasts are usually not quite ready to make milk; it can take several days to~     have enough breast milk to match a baby's nutritional needs. If there is not yet enough~     breast milk, formula is often used. However, formula can interfere with the growth of healthy~     intestinal bacteria. An alternate nutritional option is donor milk from a certified milk~     bank, which is available in all neonatal intensive care units (NICUs) in San Francisco.~     However, no scientific studies have yet studied donor milk for late preterm infants, so~     currently all San Francisco NICUs (as well as the large majority of NICUs nationwide) reserve~     donor milk for infants born at <34 weeks. This study's investigators therefore propose the~     Milk, Growth and Microbiota (MGM) Study, a randomized controlled trial to compare banked~     donor milk to formula for breastfeeding late preterm infants born in San Francisco. Once~     enrolled in MGM, infants will be randomly assigned to receive either formula or banked donor~     milk if they need additional nutrition until their mothers are making enough milk. After~     enrolling the babies, investigators will weigh them daily to assess their growth. The~     investigators will also collect infant bowel movements at baseline, 1 week and 1 month to~     determine whether donor milk vs. formula impacts the type of bacteria in the baby's~     intestine. If the study's results show that donor milk optimizes growth while helping~     establish healthy bacteria in the baby's intestine, donor milk might be postnatal strategy to~     bolster neonatal nutrition for late preterm infants.~   "
26488|NCT03220269|"~     RIAC - An Observational, Prospective, Multi-centre, Study of Epidemiology, Treatment, and~     Outcome of Cardiac Arrest in Italy.~   "
26489|NCT03220256|"~     The investigators intend to find a way to lower drug rash occurrence by applying drug~     tolerance induction protocol at the beginning of lamotrigine administration.~      Genotyping of participants with rash and those without rash after taking lamotrigine and~     genetic testing to find common gene mutations in these participants.~   "
26490|NCT03220243|"~     The purpose of this study is to determine the safety of using an autologous mesenchymal~     stromal cell (MSC) coated fistula plug in people with rectovaginal fistulizing Crohn's~     disease. This is an autologous product derived from the patient and used only for the same~     patient. Participants will be in this study for two years. There is potential to continue to~     monitor participants' progress with regular visits as part of standard of care. All study~     visits take place at Mayo Clinic and Rochester, MN.~      The study visit schedule is as follows:~      Visit 1 (Week -6) - Screening visit: exam under anesthesia and surgery to assess eligibility~     of fistula tract, take fat biopsy, if eligible, and fecal diversion.~      Visit 2 (Week 0; Day 0), exam under anesthesia for stem cell coated fistula plug placement~     Visit 3 (Week 0; Day 1) Visit 4 (Week 2; Month 1) Visit 5 (Week 4; Month 1) Visit 6 (Week 8;~     Month 2) Visit 7 (Week 12; Month 3) Visit 8 (Week 24; Month 6) Visit 9 (Week 52; Month 12).~     Visit 10 (Week 104, Month 24)~   "
26491|NCT03220230|"~     This is a non-interventional multi-center with investigational sites in Chile and Brasil~     diagnostic study to validate novel diagnostic technologies, such as Next Generation~     Sequencing (NGS) from both tissue and blood compared to the current gold standard. As a~     non-interventional study, patients will receive the treatment indicated by their doctor~     independently of their participation on this study.~      Many cancer cells look the same under the microscope. But as these cells are studied at the~     molecular level, some genetic alterations or defects that are more common to certain types of~     cancer are identified. In some cases, these defects are what make the cells grow and multiply~     abnormally.~      Biomarkers are the molecular fingerprints of these genetic defects. By testing a sample of~     your tumor for biomarkers, doctors can learn if your cancer has one of these defects, and~     that may point to a specific treatment choice.~      One of the genetic biomarkers that are believed to cause some cancers to grow is the ALK~     fusion gene. About 3% to 5% of people with NSCLC may test positive for ALK. ROS1 is a~     receptor found in 1 to 2% of people with this type of cancer.~      The present study is designed to advance the molecular testing methodologies to identify ALK+~     and ROS1+ NSCLC patients.~      A positive correlation with these new technologies will mean an efficient, more accurate~     diagnostic test, which could impact a greater number of cancer patients around world.~   "
26492|NCT03220217|"~     The purpose of this clinical research is to define the optimal dose of 68Ga-OPS202 as a PET~     imaging agent to be used to detect and localize gastro-entero-pancreatic neuroendocrine~     tumors (GEP-NETs). 68Ga-OPS202 is a radiolabelled imaging agent to be used in association~     with Positron-Emission-Tomography (PET). 68Ga-OPS202 is made of two main components: 1)~     OPS202, an antagonistic somatostatin analogue which binds to the somatostatin receptor (type~     2) present on the surface of the tumor cells and 2) Gallium 68, a radioisotope that combined~     with OPS202 can be seen in the PET scanner.~   "
26493|NCT03220204|"~     The focus of this study is to examine the feasibility, acceptability, and preliminary impact~     of a 12-week, telephone-delivered, positive psychology (PP)-based health behavior~     intervention in a group of patients with mild to moderate heart failure (HF), compared to a~     motivational interviewing- (MI-) based education condition and treatment as usual (TAU).~   "
26494|NCT03220191|"~     to evaluate the effect of the PPI (rabeprazole) on the PK of a potential commercial tablet~     formulation of palbociclib~   "
26495|NCT03220178|"~     In this study the investigators assess the impact of the eHealth-supported therapy management~     system CANKADO on Quality of Life in patients with HR+, HER2-locally advanced or metastatic~     breast cancer treated with the cyclin dependent kinase 4/6 (CDK4/6) Inhibitor Palbociclib in~     combination with an aromatase inhibitor or fulvestrant. Furthermore this approach will be~     combined with biomarker screening to identify predictive markers for and to learn more about~     adherence, symptoms, response, and resistance.~   "
26496|NCT03220165|"~     The purpose of this study is determine in healthy males how MGL-3196 is metabolized using a~     radio-labeled version of MGL-3196.~   "
26513|NCT03219944|"~     Soft tissue biotype is a critical factor for success of implant in the esthetic zone .~     Different soft tissue augmentation techniques have been employed to increase soft tissue~     thickness such as: autogenous grafts, allografts, xenografts and living cellular construct~     (LCC). Studies showed that, allografts and xenografts were inferior when compared with~     autogenous graft . However, few studies were conducted to evaluate the efficacy of soft~     tissue augmentation with platelet rich fibrin in order to overcome the patient morbidity with~     SCTG.~   "
26514|NCT03219931|"~     Infant colics represent a clinical condition in childhood, characterized by an uncontrollable~     crying that occurs without any apparent organic cause.1 They can be associated with face~     redness, closed fists, thighs flexion, meteorism, and gas emission. They are generally~     diagnosed according to Wessel's rule of three (>3 h of crying a day, for >3d a week, for~     >3wk in a row).2 These crises tend to reach their maximum intensity at 6 weeks of age, in~     most cases.3 They represent a serious source of anxiety for the family, increasing hospital~     admissions (5.8% of infants),4 postpartum depression risk, with higher stress levels for up~     to 3 years from these events. The etiology is still unknown. Anyway, it's assumed that the~     following factors may be involved: (1) Lactose intolerance. (2) Food hypersensitivity. (3)~     Feeding difficulties. (4) Disorders of the enteric nervous system. (5) Alterations of pain~     transmission. (6) Gastroesophageal reflux. (7) Intestinal hormones. (8) Psychosocial factors.~     (9) Alteration of the intestinal microbiota. In 1994, Lehtonen was the first to suggest that~     an altered intestinal microbiota composition in the very first months may induce intestinal~     colics in infants. Human intestinal microbiota is composed of about 1013 to 1014~     microorganisms, mainly bacteria. The total number of microbiota genes is called microbioma~     and it is estimated to be 150 times the number of genes in the human genome.5 It acts as a~     real organ, whose activity can be influenced by diet, lifestyle, prebiotics, probiotics, and~     antibiotics. Several studies revealed the predominance of bifidobacteria in breastfed~     infants, whereas bottle-fed infants show a mixed population where bifidobacteria are less~     represented. the intestinal microbiota composition in a 3-year-old child is already similar~     to that of an adult.6 Other factors conditioning the microbiota are gestational age and type~     of birth. Colicky infants have a microbiota with a slow development and a lower stability~     over time.7 It also contains less lactobacilli and bifidobacteria, and a prevalence of~     gram-negative bacteria. The stools of these children often show increased levels of~     calprotectin, an intestinal index of inflammation.~      RISK FACTORS ARE SEVERAL: Smoking: The exposure to cigarette smoke may be related to colics;~     this might be connected to the increase of plasma and intestinal levels of motilin. Maternal~     smoking during pregnancy seems to increase the risk of developing colics, more than postnatal~     exposition to smoke.8~      Psychosocial: Infant colics may be more frequent with an instable psychosocial family~     environment. Maternal stress, anxiety, and depression are important risk factors.8~     Breastfeeding: The difference between breastfeeding and bottlefeeding for colicky infants is~     controversial. Many studies have shown contrasting results,17 but the majority of the authors~     agree to attribute an important role to bottlefeeding. 9 A melatonin role was assumed too.~     This hormone is not secreted in infants, but only in adults, and has a hypnotic and relaxing~     role on the gastrointestinal smooth muscle. Its concentration shows a clear circadian rhythm,~     with a pick during night hours. Its presence in breast milk may be related to the lower~     occurrence of colics in breastfed infants compared with the bottle-fed infants.9 Recent~     literature shows an increasing attention toward probiotics,10 for the intestinal microbiota~     modulation. Some Lactobacillus reuteri strains were studied, with contrasting results in~     different studies; other probiotics as bifidobacteria showed in vitro anti-inflammatory~     properties and the ability to inhibit coliforms growth, whose presence is significant in~     colicky infants. Some probiotics exert a direct action on the bacterial growth, through~     bacteriocins production and final fermentation products.11 Bifidobacterium breve was isolated~     from healthy infants' feces.12 Aloisio et al13 tested in vitro ability of this strain and of~     other 45 bifidobacteria strains to oppose the growth of several microorganisms such as E.~     coli, S. enteriditis, C. difficile, K. pneumoniae, and Enterobacter cloacae. B. breve BR03,~     in a randomized clinical study, proved to have a beneficial effect on constipation in adults,~     it also seemed effective for the reduction of gas formation and for abdominal distension, and~     no side effects were shown during the treatment, while the beneficial effects lasted for up~     to 15 days after the end of the treatment.14,15 Both bifidobacteria strains showed, during an~     in vitro study, the ability to oppose 4 strains of E. coli; in particular, BR03 displayed an~     activity against E. coli O157:H7, an enterohemorrhagic strain that through Shiga toxin causes~     a potentially lethal infection.16~   "
26515|NCT03219918|"~     The study is designed to examine whether colonoscopy using an EndoRings cap has a higher~     adenoma detection rate than conventional colonoscopy. Secondary end-points is to compare~     completion rate, completion time, complication rate and detection of malignancies. Half of~     the patients will be randomised to colonoscopy using cap and the other half to no cap.~   "
26497|NCT03220152|"~     Subjects preliminarily eligible who choose to receive PrEP will be included after obtaining~     the informed consent and confirmation of eligibility within 45 days after the screening~     visit.~      Once included, participants will be examined in a follow-up visit performed four weeks later~     and evaluated for evidence of seroconversion to HIV, medication compliance and clinical~     toxicity. The second follow-up visit will occur at 12th week and every 12 weeks successively~     (quarterly). Quarterly visits include HIV testing, serum creatinine and counseling on~     medication compliance and risk reduction.~      The study has a total of 6 visits plus 2 extra visits for those participants enrolled in the~     PK study. In all visits will be assessed the risks, HIV testing will be performed, monitoring~     of renal function and dispensing of the drug Truvada [emtricitabine 1 tablet (FTC) /~     tenofovir (TDF) (200/300 mg) once a day orally for 12 months].~      Participants who have completed 48 weeks of follow-up or prematurely discontinue a PrEP will~     be encouraged to return for a follow-up visit after discontinuation of medication for~     monitoring of the status and evaluation of HIV as the resolution of side effects.~   "
26498|NCT03220139|"~     Background Cancer and cardiovascular diseases combined account for more than 50% of the~     overall mortality burden in the USA. Accumulating evidence indicates that saturated fat~     intake is related to an increase, while unsaturated fat intake is related to a decrease in~     all-causes mortality. Thus, current US dietary guidelines recommend a shift from saturated to~     unsaturated fat.~      Objective The aim of the present study was to estimate the mortality risk reduction related~     to a dietary change from saturated fat to an equal amount of mono or polyunsaturated fat~     intake.~      Design The American National health and nutrition examination surveys conducted between 1999~     and 2010 were linked to the 2011 national US death registry resulting in an observational~     prospective mortality study. Proportional hazards Cox models were used to evaluate the~     association between saturated, mono-unsaturated and poly-unsaturated fat with all-cause, and~     cause specific mortality. Substitution analysis was conducted to estimate an iso-caloric~     substitution of 10% of the energy from dietary fat intake applied to the substitution of~     saturated fat with an equal amount of energy from mono-unsaturated or poly-unsaturated fat.~   "
26499|NCT03220126|"~     The purpose of this study is to look at the amount of the study drug, LY3074828, that gets~     into the blood stream and how long it takes the body to get rid of LY3074828 when given~     together with LY9999QS compared to LY3074828 alone. The tolerability of the different~     formulations will also be evaluated and information about any side effects experienced will~     be collected.~      Screening is required within 28 days prior to the start of the study. For each participant~     the total duration of the clinical trial will be approximately 13 weeks, not including~     screening.~   "
26500|NCT03220113|"~     The purpose of the study is assessment of the safety and efficacy of the De-Novo therapy in~     the treatment of craniofacial neuralgia and migraine headaches.This is an open-label study of~     simultaneous administration of combination of dexamethasone, lidocaine, and thiamine into the~     trigeminal nerve branches as well as greater and lesser occipital nerve bilaterally in one~     session.~      Patients who meet the exclusion and inclusion criteria are eligible for trial if they have~     experienced chronic migraine and craniofacial pain not responding to other prior therapies.~   "
26501|NCT03220100|"~     This research study is evaluating a new way to provide palliative care to patients who have~     recently been diagnosed with lung cancer. . Palliative care is a medical specialty focused on~     lessening (or palliating) patients' symptoms and helping patients and their families cope~     with a serious illness.~   "
26502|NCT03220087|"~     The objective of this study is to describe the use of resources and the costs associated with~     controlled or uncontrolled CS in patients with NETs in Spain.~   "
26503|NCT03220074|"~     A prospective open study to determine the efficacy and tolerability of oral linezolid~     600mg./day for the treatment of 50 patients with nontuberculous mycobacterial diseases will~     be conducted at Siriraj Hospital, Mahidol University, Bangkok, Thailand.~   "
26504|NCT03220061|"~     Effectiveness of music therapy on blood pressure and anxiety among patients undergoing~     haemodialysis~   "
26505|NCT03220048|"~     Phase 2 study, looking at the prophylactic efficacy, safety and tolerability to a repeated~     nasal dose of study drug after being infected with Influenza A/Perth/16/2009 (H3N2) virus.~   "
26506|NCT03220035|"~     This phase II Pediatric MATCH trial studies how well vemurafenib works in treating patients~     with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with BRAF V600 mutations~     that have spread to other places in the body and have come back or do not respond to~     treatment. Vemurafenib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~   "
26507|NCT03220022|"~     This phase I trial studies the side effect and best dose of ibrutinib in combination with~     rituximab, etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin~     hydrochloride in treating patients with human immunodeficiency virus (HIV)-positive stage~     II-IV diffuse large B-cell lymphomas. Ibrutinib may stop the growth of cancer cells by~     blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as~     rituximab, may interfere with the ability of cancer cells to grow and spread. Drugs used in~     chemotherapy, such as etoposide, prednisone, vincristine sulfate, cyclophosphamide, and~     doxorubicin hydrochloride, work in different ways to stop the growth of cancer cells, either~     by killing the cells, by stopping them from dividing, or by stopping them from spreading.~     Giving ibrutinib and etoposide, prednisone, vincristine sulfate, cyclophosphamide, and~     doxorubicin hydrochloride may work better in treating patients with HIV-positive diffuse~     large B-cell lymphomas.~   "
26508|NCT03220009|"~     This randomized phase II trial studies how well nivolumab or expectant observation following~     ipilimumab, nivolumab, and surgery work in treating patients with high-risk mucosal melanoma~     that is restricted to the site of origin without evidence of spread, has spread to a local~     and regional area of the body, or has come back. Monoclonal antibodies, such as nivolumab and~     ipilimumab, may interfere with the ability of tumor cells to grow and spread. Sometimes the~     mucosal melanoma may not need more treatment until it progresses. In this case, observation~     may be sufficient. It is not known if nivolumab or expectant observation following~     ipilimumab, nivolumab, and surgery may be better in treating patients with mucosal melanoma.~   "
26509|NCT03219996|"~     The investigators performed a retrospective, single-center observational study, and the~     participants with acute fulminant myocarditis were included.Then, the investigator analyzed~     the risk factors of in-hospital death in these participants with acute fulminant myocarditis.~   "
26516|NCT03219905|"~     Kinesio-taping (KT) has recently gained so much popularity and a growing number of physicians~     started using it to alleviate musculoskeletal symptoms. It was originally developed by Kenzo~     Kase in 1976. The effects of KT on ankle proprioception and stability have been investigated~     in previous studies. However, these studies are limited and the current data is conflicting.~     Repeated application of KT in a patient with chronic ankle instability has been shown to be~     effective in improving balance. In basketball players with chronic ankle sprain, KT did not~     improve or inhibit balance. Application of KT did not cause a significant change in balance~     of healthy subjects. The aim of this study was to evaluate the immediate and short-term~     effects of KT on balance of healthy subjects.~   "
26517|NCT03219892|"~     This study is a double blind comparative study examining the effectiveness of the rTMS~     treatment on Freezing of Gait (FOG) in patients with Parkinson's disease (PD). The~     investigators hypothesize that treatment with rTMS on supplemental motor area will improve~     gait quality and decrease the frequency of FOG in PD patients.~   "
26518|NCT03219879|"~     This study determines the effectiveness of telephone-delivered cognitive-behavioral~     continuation therapy (T-CT) in comparison to usual care in people with recurrent or chronic~     depression. The primary research question is whether participating in T-CT reduces depressive~     relapses. The continuation therapy comprises eight therapy sessions delivered over the~     telephone by a trained therapist over a period of approximately six months following~     acute-phase psychotherapy.~   "
26519|NCT03219866|"~     This will be a non-blinded feasibility (pilot) study comparing triple therapy nebulizer vs~     dry powdered inhalers (DPI) for care transitions in COPD exacerbation patients.~      We hypothesize that patients treated in hospital and discharged on respiratory medications~     administered by nebulizers will exhibit better quality of life (QoL), symptom control, and~     lower COPD and all cause hospital readmission rates compared with patients treated with~     respiratory medications delivered by DPI.~      We aim to demonstrate that:~        1. Patients treated and discharged on nebulized bronchodilators will have fewer~          readmissions to hospital at 30 and 90 days compared to the group utilizing DPI~        2. The nebulizer group will demonstrate a longer duration of time until hospital~          readmission for COPD and all cause readmission compared to the group utilizing DPI~        3. The nebulizer group will demonstrate better QoL (measured by the SGRQ - Saint George~          Respiratory Questionnaire) and symptom control (as measured by the CAT & mMRC) compared~          to the group utilizing DPI.~   "
26520|NCT03219853|"~     Study aims to investigate 2 topics:~        1. Flavour-Nutrient Learning (FNL) FNL proposes that personal food preferences may be~          influenced by unconscious mechanisms which operate to ensure the safeguarding of~          individual nutrient levels. The theory postulates that food preferences may change over~          time to address changing nutritional status (Yeomans, 2012).~           This study aims to explore FNL in humans by investigating the preferences of~          participants with low and high blood-selenium levels in relation to selenium-enriched~          parsnips. Participants will be investigated in a two-week trial in which they will~          undertake two food sensory tests: one before, and one after, the two-week period where~          they will incorporate provided parsnips into their diet.~           Some provided parsnips will contain higher levels of selenium than others, neither the~          participants nor the lead researcher will know which type of parsnip each participant~          receives.~           It is hypothesised that the second food sensory test, performed after the intervention~          period, will show that participants of lower initial blood-selenium levels will~          demonstrate an increased liking for the selenium-enriched parsnips. This may demonstrate~          possible FNL in humans.~        2. Relationship between selenium intake & plasma selenium-status. This study will also~          examine the relationship (if any) between the selenium intake of all participants via~          the different types of parsnips, and their individual blood-selenium levels.~      This will be assessed via blood tests before, during and after the trial in order to observe~     the blood-selenium levels of each participant.~      It is hypothesised that the blood-selenium levels of participants of lower initial selenium~     readings will be the most improved upon consumption of selenium-enriched parsnips.~   "
26521|NCT03219840|"~     This placebo-controlled, double-blinded, randomized crossover study evaluates the plaque and~     gingivitis reducing capacity of Cetylpyridium Chloride (CPC) chewing gum, with mechanical~     oral hygiene. The study will enroll 73 students, faculty, and staff from the UTHealth School~     of Dentistry. Half of the eligible participants will be randomly assigned to get the CPC gum~     in the first treatment period (21 days), a wash-out period of 21 days, and then a placebo gum~     in the second treatment period (21 days). The other half will be assigned to follow the same~     schedule but with the treatment reversed. A statistician will perform the randomization.~     Primary outcomes are assessed by validated tools, such as the Plaque Index (PI), Gingival~     Index (GI), and percent of bleeding sites on probe (BOP).~   "
26522|NCT03219827|"~     Severity of allergic reactions are highly variable from one individual to another, they can~     range from absent to life threatening. Allergic manifestations and specifically those of~     anaphylactic reactions are generally attributed to an IgE-dependent activation of mast cells~     and/or basophils followed by the release of histamine. Recently however evidence accumulated~     that other pathways might similarly contribute or even trigger anaphylaxis. Moreover, while~     the variance in human populations is an important subject to scientific research, medical~     practices and public health policies typically take a 'one for all' approach to disease~     management and drug development. Indeed, individual heterogeneity in the immune response can~     have a big impact on the likelihood to respond to therapy. Because of the complexity of~     immune responses in the individual and within the population, it has not been possible thus~     far to define the parameters (genetic or environmental) that define the immune system of~     allergic patients and its natural occurring variability. Thanks to the efforts that have been~     made in the framework of the Labex Milieu Intérieur study genetic, immunological and~     environmental factors have been identified that can be linked to the heterogeneity of immune~     responses in healthy individuals. By comparing these already available data from healthy~     individuals to a novel cohort of patients with defined severe allergic manifestations, we~     will be able to identify for the first time immunological and environmental parameters that~     are common to patients with severe allergies and identify those parameters that distinguish~     allergic patients from the healthy donor cohort. This analysis will thus open new~     perspectives on deregulated immune pathways in allergic patients allowing to orient future~     treatment approaches. Furthermore, comparing immune responses before and after~     allergen-specific immunotherapy will help understanding, which changes in immune responses~     are causal to a successful treatment. Importantly, this analysis will shed light on the~     individual differences that may predict the outcome of treatment approaches and propose novel~     markers of its success.~   "
26523|NCT03219814|"~     The purpose of this study is to assess a cognitive dissonance-based eating disorder~     prevention intervention program on its ability to reduce attentional biases in~     body-dissatisfied women.~   "
26524|NCT03219801|"~     This study is to evaluate the safety and efficacy of human umbilical cord derived mesenchymal~     stem cells transplantation in systemic lupus erythematosus.~   "
26525|NCT03219788|"~     The number of obese and overweighted persons doubled since 1980. They are 600 million in 2014~     all over the world. Obesity results in anatomical, physiological and pharmacological changes~     which represent a challenge for every anesthetist. Difficult airway increases by 30% with~     obesity and so awake extubation are the preferred technique. Coughing can be alleviated by~     opioid receptors which play a role in the cough reflex. Remifentanil may be useful as an~     ultra-short acting opioid and its effect swiftly and predictably disappears after cessation.~     An emergence cough is attenuated by remifentanil administered via continuous infusion (TCI),~     and the expected effective effect-site concentrations investigated have ranged from 1.5 to~     2.5 ng.ml/L.~   "
26526|NCT03219775|"~     TITAN-TCC (0416-ASG) is a Phase 2, open-label study of nivolumab (BMS-936558) monotherapy~     with additional nivolumab/ipilimumab boost cycles in previously untreated and~     platinum-based pretreated, 2nd and 3rd line, advanced or metastatic transitional cell~     carcinoma subjects. Nivolumab is a fully human PD-1 antibody which blocks the respective~     immune checkpoint in a ligand (PD-L1/PD-L2) independent manner.~   "
26527|NCT03219762|"~     Evaluate the activity and safety of Nab-paclitaxel in patients with sensitive or refractory~     SCLC who relapsed after cisplatin or carboplatin and etoposide first-line chemotherapy.~   "
26528|NCT03219749|"~     Obstructive sleep apnea (OSA) results in vascular dysfunction, which increases the risk of~     cardiovascular disease. In contrast, exercise confers cardioprotection through improvements~     in vascular health. This proposal evaluates whether the beneficial effects of exercise on~     vascular function are attenuated in obese individuals suffering from untreated OSA.~   "
26529|NCT03219736|"~     Study Summary:~      Title: A Randomized Controlled Trial of Noninvasive Positive Airway Pressure in the Pediatric~     Emergency Department for the Treatment of Acute Asthma Exacerbations~      Principal Investigator: Thomas J. Abramo, MD~      Hypothesis: For acute moderate to severe pediatric asthma exacerbations the use of~     NIPPV/BiPAP, in conjunction with current standard of care therapies, will lead to a more~     rapid improvement in patient ventilation, faster resolution of respiratory distress and~     result in improved ventilatory parameters, secondary outcomes and pediatric asthma scores.~      Study Design: Prospective, randomized controlled trial~      Study Duration: This study will be conducted over a 36 month period.~      Sample Size: 240 subjects~      Population: Children ages 2-17 years of age presenting to the ED with Acute asthma~     exacerbation and a Pediatric Asthma Score (PAS) ≥ 8.~      Synopsis: Eligible subjects will be randomized to either a control group or study groups. The~     study groups will be either a NIPPV/BiPAP group. The subjects in the study groups will~     continue to receive all standard of care therapies per the asthma severity protocols. All~     nebulized therapies will be given through the NIPPV circuit. Patients will be assessed by the~     pediatric asthma score (PAS), measured respiratory parameters, volumetric end tidal carbon~     dioxide monitoring and measured cardiac parameters.~      Objectives: A. Evaluate if the use of NIPPV/BiPAP in conjunction with traditional inhaled~     beta-agonists improves the outcome in pediatric patients with acute moderate to severe asthma~     in the acute setting.~      B. Describe the physiology of NIPPV/BiPAP by measuring cardiac parameters in children~     randomized to a NIPPV group.~      C. Monitor safety of NIPPV/BiPAP use for acute asthma exacerbations in children.~      Safety A.: The study must be IRB approved.~      B.: Appropriate consent and assent documents will be obtained prior to enrolling the subject~     in the study.~      C.: A clear safety plan including DSMB will be established to monitor for adverse events.~      D.: Confidentiality will be ensured for all subjects enrolled in the study.~   "
26530|NCT03219723|"~     The purpose of this study is to evaluate the safety and efficacy on patients receiving~     first-line eradication and second-line eradication including vonoprazan (Takecab) tablets~     (triple therapy) in the routine clinical setting.~   "
26531|NCT03219710|"~     Chemotherapy induced nausea and vomiting (CINV) is one of the most distressing toxicities of~     cancer treatment. It can occur up to 90% in case of highly emetogenic chemotherapy (HEC) use.~     It is important to effectively manage CINV for a number of reasons. Acute phase vomiting can~     lead to vomiting in the delayed phase. It causes poor compliance with further therapy.~     Quality of life is compromised. It is easier to prevent nausea/vomiting than to treat it.~     Though strategies for prevention of CINV have been improved, it is still a significant~     problem. Newer drugs were explored and studied. The complete response rates were further~     increased with usage of olanzapine, an FDA approved antipsychotic, which blocks multiple~     neurotransmitters in the central nervous system.~      Olanzapine has been studied in multiple randomized trials in adults for its safety and~     efficacy in prevention of CINV. Various RCTs have demonstrated the superiority of olanzapine~     for prevention of CINV in patients receiving highly and moderately emetogenic chemotherapy.~     Olanzapine has been approved for prevention of CINV in adults.~      Unfortunately there are no large randomized trials demonstrating the efficacy of olanzapine~     for CINV prevention in children receiving HEC. The positive experience with olanzapine~     reported in adult oncology patients has prompted some pediatric clinicians to prescribe~     olanzapine for individual children receiving chemotherapy. Olanzapine is frequently used for~     the treatment of schizophrenia and bipolar disorder in children and adolescents. Though~     various studies have demonstrated safety of olanzapine in children, data regarding the~     efficacy of olanzapine in children and adolescents for prevention of CINV is limited. There~     are many small studies describing the safety and efficacy of olanzapine for prevention of~     CINV. However, there are no large randomized trials. Olanzapine is available in generic form~     and is not an expensive drug. Therefore we would like to conduct a randomized trial to look~     for the efficacy of olanzapine in pediatric population for prevention of CINV~   "
26532|NCT03219697|"~     This study will determine whether a primary care based intervention that combines group based~     parenting skills training and public health nurse home visits with a focus on healthy~     nutrition, activity and sleep, compared to regular health care will lead to improved weight~     status in 18 months-3 year old children.~      Healthy children at risk for obesity will be identified through primary care practices~     participating in TARGet Kids!. Families who participate in this study will be randomly~     assigned (having an equal chance of being in either group) to one of the two study groups~     that will run for 6-months:~      Group A: Receive 10-weeks of group parenting education sessions with 2-4 public health nurse~     home visits Group B: Receive regular health care~      In addition to the measures collected as part of TARGet Kids!, research assistants will~     collect the following information about you and your child before the start of the trial, and~     after 6-months:~      Parenting Questionnaires from the parent Depression, Anxiety, Stress Scale (DASS-21) from the~     parent A blood sample from your child~      We will measure the differences in weight, height, social, emotional and behavioural health,~     nutrition, physical activity, sleep, risk for heart disease and diabetes, and health care~     use.~   "
26533|NCT03219684|"~     Nephrotic syndrome (NS) is among the most common pediatric kidney diseases and is defined as~     massive proteinuria (>40 mg/m2/h or urine protein to creatinine ratio >2 g/g) leading to~     hypoalbuminemia (<2.5 g/dL), edema, and hyperlipidemia. 60-70 % of patients present prior to~     age of 6 years~   "
26534|NCT03219671|"~     A Phase 2 study of nivolumab plus ipilimumab in previously treated classical Kaposi Sarcoma~     (CKS)~   "
26535|NCT03219658|"~     This internal pilot study will determine whether a highly promising primary care based~     intervention that combines group based parenting skills training and public health nurse home~     visits with a focus on healthy nutrition, activity and sleep, will lead to improved weight~     status in 1 to 5 year old children with severe obesity.~      Children with severe obesity will be identified through the obesity management clinical~     program at The Hospital for Sick Children called STOMP (SickKids Team Obesity Management~     Program). The STOMP Early Years Program is a unique and intensive, paediatric obesity~     management program designed for 1 to 5 year-olds with severe obesity and their families.~     Families who participate in this study will be randomly assigned (having an equal chance of~     being in either group) to one of the two study groups that will run for 6 months:~      Group A: Ten weeks of group parenting education sessions with 2-4 public health nurse home~     visits and four one-on-one check-ins with an interdisciplinary team at STOMP.~      Group B: Wait listed to receive parenting education sessions; receive one-on-one checks with~     an interdisciplinary team at STOMP.~      In addition to the measures collected as part of STOMP, families will complete the following~     questionnaires before the start of the trial, and after 6 months:~      Parenting Scale, Parenting Stress Index, Depression, Anxiety, and Stress Scale (DASS-21),~     Cost Questionnaire, and Children's Behaviour Questionnaire (CBQ).~   "
26536|NCT03219645|"~     This study evaluates the addition of Ginkgo Diterpene Lactone Meglumine Injection to aspirin~     in the treatment of acute ischemic stroke.Half of patient will receive Ginkgo Diterpene~     Lactone Meglumine Injection(25mg once/day D1-D14) and aspirin(300mg loading dose,then 100mg~     once/day D2-D14) in combination, while the other half will receive aspirin(300mg loading~     dose,then 100mg once/day D2-D14).~   "
26537|NCT03219632|"~     Assess the efficacy of fimasartan on left ventricular hypertrophy in hypertensive patients~   "
26538|NCT03219619|"~     Examination of major duodenal papilla (MDP) using a side-viewing duodenoscope is a golden~     standard. However, side-viewing duodenoscope is not available in some endoscopic centers.~     Cap-assisted esophagogastroduodenoscopy (Ca-EGD) using a transparent cap fitted to the tip of~     the scope has emerged as an alternative method for the observation of MDP. A recent study~     showed that complete examination of MDP could be achieved in 97% of patients. The~     investigators hypothesize that Ca-EGD is non-inferior to duodenoscope for the observation of~     MDP.~   "
26539|NCT03219606|"~     The aim of the study is evaluating the efficacy of organized education process of the~     modified Rodnan Skin Score (MRSS) in the systemic sclerosis. Ten physician in South Korea~     will be voluntarily enrolled and receive the organized training program, which encompass the~     lecture and demonstration of skin scoring by expert rheumatologist. Reliability and accuracy~     of the skin scoring before and after the education will be compared.~   "
26540|NCT03219593|"~     The study is to investigate the efficacy and safety of apatinib for the first-fine treatment~     in elderly patients with locally advanced or metastatic adenocarcinoma of stomach or~     gastroesophageal junction, unable or unwilling to chemotherapy, through progression-free~     survival (PFS). Apatinib will be given to patients with an efficacy assessment of stable~     disease (SD), partial response (PR), or complete response (CR) every 2 cycles. Patients were~     assigned to 500 mg/d apatinib continually until disease progression or intolerable toxicity~     or patients withdrawal of consent. The dose of apatinib may be decreased to 250 mg/d~     following the occurrence of a clinically significant adverse event (AE). Treatment will be~     discontinued if the subject is unable to tolerate a daily dose of 250 mg, and the sample size~     is about 30 individuals. Tumor tissue samples will be collected from each enrolled subjects~     before the start of treatment, and detected using next generation sequencing (NGS)-based~     comprehensive genomic profiling. The potential biomarkers in predicting apatinib efficacy or~     safety will be explored.~   "
26541|NCT03219580|"~     This is a double (physician and patient) blinded randomized controlled clinical trial in~     which patients who have undergone bilateral direct brow ptosis repair undergo a trial in~     which one of brow is injected with placebo 0.9% Normal Saline and the contra-lateral brow is~     injected with 0.3-0.6 mL over the entire brow of 50mg/mL 5-Fluorouracil sub-dermal~     injections. The researchers aim to investigate whether injecting 5-Fluorouracil preemptively~     will not only accelerate wound healing and decrease hypertrophic scar formation compared to~     placebo, but also improve overall scar appearance in a safe manner.~   "
26542|NCT03219554|"~     This is a phase II single center, open-label, single arm study of palbociclib treatment in~     patients with recurrent or metastatic advanced TETs after failure of one or more cytotoxic~     chemotherapy regimens. Patients will receive oral palbociclib 125mg daily for 21days followed~     by a 7-day break. Cycle will be repeated every 28 days.~   "
26543|NCT03219541|"~     The purpose of this study is to develop and then test the feasibility, acceptability, and~     preliminary effect of a bidirectional text message smoking cessation intervention among~     Vietnamese smokers in Hanoi, Vietnam. The specific aim are: 1) To develop a smoking cessation~     text message library among Vietnamese smokers; 2) To evaluate message preferences, and the~     feasibility and acceptability of the bidirectional text message smoking cessation~     intervention; and 3) To assess the preliminary effect of a bidirectional mobile phone text~     message intervention on biochemically validated smoking abstinence.~   "
26544|NCT03219528|"~     Diarrhea-predominant irritable bowel syndrome (IBS-D) is a highly prevalent but poorly~     understood condition with limited treatment options. Current therapies, including a~     nonabsorbable antibiotic rifaximin or diet low in fermentable oligosaccharides,~     disaccharides, monosaccharides, and polyols (FODMAP), show efficacy in 50% or less of~     patients. In this proposal, we will randomize IBS-D patients to receive either rifaximin or~     low FODMAP dietary intervention.~   "
26545|NCT03219515|"~     This is a prospective, multicenter, randomized, double-blinded, placebo-controlled,~     parallel-group, clinical trial to explore the effectiveness of an herbal medication,~     Gongjin-dan (GJD) for chronic dizziness (Ménière disease, psychogenic dizziness, or dizziness~     of unknown cause), identified as liver-deficiency pattern/syndrome, and assessed with~     Dizziness Handicap Inventory (DHI) ≥ 24 at baseline. Participants will be randomized and~     allocated to either GJD or placebo group with 1:1 ratio and orally administered GJD or~     placebo pills once a day for 8 weeks. For collecting data for cost-effectiveness analysis,~     the participants will be followed up to 12 months from randomization.~   "
26546|NCT03219502|"~     The goal of this research study is to learn if using a type of therapy called repetitive~     transcranial magnetic stimulation (rTMS) can help improve chemotherapy-related peripheral~     neuropathy (CIPN). Peripheral neuropathy is nerve damage with possible numbness, pain, and/or~     loss of motor function. Researchers also want to learn if it can improve quality of life and~     mental health.~      rTMS is designed to change brain activity by introducing small magnetic impulses to the scalp~     that encourage the brain to change its activity.~      In this study, rTMS will be compared to sham rTMS. Sham rTMS is not an actual treatment. It~     is designed to look like rTMS, but does not treat any disease or illness. It will be compared~     with rTMS to learn if rTMS has any real effect.~      This is an investigational study. The equipment used in this study is FDA approved and~     commercially available. Using rTMS equipment to treat CIPN is considered investigational. The~     study doctor can explain how the equipment is designed to work.~      Up to 60 participants will be enrolled in this study. All will take part at MD Anderson.~   "
26558|NCT03219346|"~     The prevalence of chewing dysphagia in the domestic rehabilitation department ward was about~     53.61%.Nasal tube retention of about 31%, due to nasogastric tube feeding, often overlooked~     oral hygiene, easy to cause respiratory tract infection. At the same time, oral hygiene will~     also affect the effectiveness of swallowing treatment, is worthy of attention to health~     problems.~   "
26547|NCT03219489|"~     Progesterone can be given to women at risk for preterm birth, and is advocated by many~     guidelines as progesterone has been shown to markedly decrease preterm birth, death in~     newborns, and disability. However, not all eligible women are currently receiving this~     medication. Thus, there is an urgent need to improve prevention of preterm birth with~     progesterone. In response to the low number of women receiving this medication, the~     investigators have designed a potential method to increase progesterone use.~      This method involves the use of an alert programmed into electronic medical records, to~     prompt doctors to prescribe progesterone to women at risk of preterm birth. This study is a~     randomized controlled trial that will assess the feasibility of using this alert, by~     randomly assigning 8 clinics to either use this alert, or to provide their usual prenatal~     care. The investigators will then study whether the alert improved prescription of~     progesterone, and examine neonatal outcomes such as preterm birth and birth weight. Care~     providers will be asked for their feedback and thoughts about the alert, through~     questionnaires and structured interviews.~      The investigators hypothesize that the electronic medical record alert will increase care~     provider recommendations and prescription of progesterone for women at risk of preterm birth.~     The investigators hope that this study will lay the groundwork for larger future studies~     aimed to strengthen health care quality and improve the health outcomes of women and their~     babies.~   "
26548|NCT03219476|"~     This is an exploratory interventional study that initiates standard-of-care anti-estrogen~     treatment preoperatively for four weeks.~   "
26549|NCT03219463|"~     The purpose of our graduate student research study is to observe the effects of ginger on~     hsCRP, IL-6, and TNF-α levels in exercising individuals based on their level of activity.~   "
26550|NCT03219450|"~     This research study is studying a novel type of CLL vaccine as a possible treatment for~     chronic lymphocytic leukemia (CLL)~      The names of the study interventions involved in this study are:~        -  Personalized NeoAntigen Vaccine~        -  Poly-ICLC~        -  Cyclophosphamide~   "
26551|NCT03219437|"~     The purpose of this study is to compare the safety and efficacy of risankizumab to~     methotrexate in participants with moderate to severe plaque psoriasis.~   "
26552|NCT03219424|"~     To evaluate return to work (RTW) status after moderate and major trauma in Hong Kong at one~     year after injury. To derive reliable prediction models for return to work.~   "
26553|NCT03219411|"~     The transition from normal glucose tolerance to overt type 2 diabetes mellitus (T2D)~     encompasses a variety of glycemic abnormalities that are commonly referred to as~     'prediabetes'. While intensive lifestyle interventions are the cornerstone of T2D prevention,~     developing safe, cost-effective adjunct therapeutic strategies is a clinically relevant goal.~     Cinnamon supplementation has been shown to improve fasting plasma glucose in patients with~     T2D. This placebo-controlled, randomized study will determine if cinnamon improves glucose~     homeostasis in patients with prediabetes over a 12-week period.~   "
26554|NCT03219398|"~     This study aimed to evaluate the increase of intraabdominal pressure 12- 14 mmHg caused by~     pneumoperitoneum resulted from carbon dioxide (CO2) insufflation induce glycocalyx~     endothelial injury that cause kidney tubular injury on live donor patient that undergo~     laparoscopic nephrectomy surgery, and decreasing the intraabdominal pressure to 8-10 mmHg~     during surgery is expected to reduce the injury.~   "
26555|NCT03219385|"~     The purpose of this clinical study is to assess the safety and effectiveness of the Mirabilis~     System for treating uterine fibroids in women who are seeking relief from fibroid-related~     abnormal uterine bleeding but want to avoid hysterectomies or other surgical procedures. The~     Mirabilis System is an investigational device that delivers high-intensity focused ultrasound~     (HIFU) to the uterus using integrated ultrasound imaging guidance to offer noninvasive~     treatment for uterine fibroids. With the Mirabilis System, HIFU is applied noninvasively~     through the skin using an applicator that is placed against the abdomen. No incisions or~     surgical procedures are required. During this study, eligible patients will have one or more~     fibroids treated with the Mirabilis System and will then remain in the study for a total of~     36 months after treatment to monitor the occurrence of adverse events. Primary endpoints will~     be assessed at 12 months after treatment, while secondary endpoints will be assessed at~     variable times ranging from immediately after treatment up to 36 months after treatment.~   "
26556|NCT03219372|"~     Hepatocellular Carcinoma (HCC) is a major health concern in the United States, particularly~     among people with liver cirrhosis. Out of every 100 patients with liver cancer, only 18 will~     survive 5 years or more. While locoregional therapies are utilized in an effort to combat~     this disease, the recurrence rate of HCC after these therapies are high.~      Statins are widely used drugs that lower cholesterol levels. Some studies have suggested that~     statins lower risk of HCC recurrence, but this possibility has not been studied thoroughly in~     a clinical trial. This study will examine the effects of pravastatin, a type of statin, on~     time to HCC recurrence in patients with early stage HCC. It is possible that pravastatin in~     combination with locoregional therapies may delay or protect against HCC recurrence.~   "
26557|NCT03219359|"~     Crohn's Disease (CD) is an inflammatory bowel disease. It can lead to significant~     complications and discomfort in the stomach and intestines. Crohn's disease is a~     debilitating, incurable disease of immune cells; it affects almost 1 million people in the~     United States. CD is characterized by inflammation of the stomach and intestine as well as~     organs outside of the intestines such as the skin, eyes, and joints. Current therapies to~     treat CD aim to suppress the patient's immune cells but these therapies become ineffective~     for the majority of patients and lead to complications including the requirement for surgical~     bowel resection, impaired quality of life, and lifelong disability. Hematopoietic stem cell~     transplantation (HCT) is a procedure used to treat a number of medical conditions including~     Crohn's disease. To improve success of HCT in CD doctors considered combining transplant with~     other drugs to improve the chances of achieving remission and also maintaining the remission.~     The Investigators' plan in this study is to incorporate the drug Vedolizumab after transplant~     to test if this drug will improve remission and make patients healthier.~      Patients may qualify to take part in this research study because Crohn's disease is active,~     because surgery is not a treatment option and because there is evidence that the disease has~     failed to respond to treatments for Crohn's disease including the following:~        -  corticosteroids~        -  azathioprine, 6-mercaptopurine, methotrexate~        -  Anti-TNFα (infliximab, adalimumab, certolizumab, golimumab)~        -  Anti-integrin agents (natalizumab, Vedolizumab) If patients meet entry criteria will~          undergo a baseline endoscopy, colonoscopy and MR or CT enterography. If documentation of~          active mucosal disease patients will then be tapered off of current medications and~          undergo stem cell mobilization. Mobilization will involve low dose chemotherapy, growth~          factors and require 1-2 week hospitalization. Patients will then undergo stem cell~          transplant which will involve high dose chemotherapy and require a 2-4 week~          hospitalization. After restoration of the immune system patients will be placed on~          vedolizumab per standard dosing (0,2,6 then 8 every weeks) for a total of 8 doses.~          Patients will have monthly study visits and a repeat colonoscopy and MR/CT scan at 6~          months.~   "
26559|NCT03219333|"~     This is a study that will test how an experimental drug (enfortumab vedotin) affects patients~     with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of~     the bladder, renal pelvis, ureter or urethra that has spread to nearby tissues or to other~     areas of the body.~      This clinical trial will enroll patients who were previously treated with a kind of~     anticancer drug called an immune checkpoint inhibitor (CPI). Some CPIs have been approved for~     the treatment of urothelial cancer.~      This study will test if the cancer shrinks with treatment. This study will also look at the~     side effects of the drug. A side effect is a response to a drug that is not part of the~     treatment effect.~      Patients who sign up for this trial must also fall into one of these categories:~        -  Patients have already received treatment with platinum-containing chemotherapy~        -  Patients have never received platinum-containing treatment and are not eligible for~          treatment with cisplatin.~   "
26560|NCT03219320|"~     To evaluate the efficacy of multiple dose levels of NYX-2925 versus placebo in treating the~     neuropathic pain associated with Diabetic Peripheral Neuropathy.~   "
26561|NCT03219307|"~     This study is prospective single arm extension study of protocol AAG-G-H-1220. It is open~     only to participants of AAG-G-H-1220 randomized to the Microfracture treatment group.~   "
26562|NCT03219294|"~     During many surgeries, increased muscle tension makes it harder for the surgeon to expose the~     site of surgery and work within the incision. Neuromuscular blockade (NMB) drugs such as~     Vecuronium bind to neurotransmitter (acetyl choline) receptors at the neuromuscular junction,~     blocking their action and producing muscle relaxation. This muscle relaxation allows easier~     retraction of muscle tissues and manipulation of structures in the wound. Improved surgical~     conditions are likely to result in improved patient outcomes. While increased depths of NMB~     have been shown to optimize surgical conditions during intra-abdominal and retroperitoneal~     procedures, the impact of NMB depth has not been reported for orthopedic surgeries.1 To~     address this, we propose to study the effect of NMB depth on surgical conditions during total~     hip replacement (THR).~   "
26563|NCT03219268|"~     The primary goal of this Phase 1 study is to characterize the safety and tolerability of~     MGD013 and establish the maximum tolerated dose (MTD) of MGD013. Pharmacokinetics (PK),~     immunogenicity, pharmacodynamics (PD), and the anti-tumor activity of MGD013 will also be~     assessed.~   "
26564|NCT03219255|"~     This study aims to investigate the long-term safety and efficacy of RELVAR® 100 ELLIPTA®~     (hereinafter referred to as Relvar) in daily clinical practice in subjects with chronic~     obstructive pulmonary disease (COPD), who are naive to RELVAR. A total of 1000 subjects, from~     approximately 200 medical institutions, will be registered for this study and 332 of them~     will be considered for safety analysis. In the investigation, subject registration and data~     collection will be conducted using an Electronic Data Capture (EDC) system.~     Post-registration, the investigator will monitor the information regarding the safety and~     efficacy of RELVAR for one year from the start date of treatment with RELVAR. Pneumonia,~     systemic effects caused by corticosteroids and cardiovascular events will be considered as~     the priority investigation matters. At the end of observation period, the investigator will~     enter the obtained information into the EDC system and submit it. RELVAR 100 ELLIPTA is the~     registered trademark of GlaxoSmithKline (GSK) group of companies.~   "
26565|NCT03219242|"~     Longitudinal prospective study on primary debulking surgery including bowel resection in~     advanced stage ovarian cancer patients using Caiman® technology~   "
26566|NCT03219229|"~     Young children have a high resting energy expenditure (REE) relative to their body weight and~     metabolically active compartment, fat-free mass (FFM). Both body weight and FFM are, however,~     metabolically heterogeneous and include organs and tissues varying widely in specific~     metabolic rate (i.e., organ REE/kg/d). One prevailing hypothesis is that most, if not all, of~     the higher REE observed in young animals and children compared to adults can be accounted for~     by a larger proportion of high metabolic rate components such as brain, liver, and heart..~   "
26567|NCT03219216|"~     This is a Phase 3b, open-label, multicenter study to evaluate the efficacy and safety of~     Glecaprevir (GLE)/Pibrentasvir (PIB) combination for an 8 or 12-week treatment duration in~     adults in Brazil with chronic hepatitis C virus (HCV) genotype (GT) 1 - 6 infection, without~     cirrhosis or with compensated cirrhosis, who are HCV treatment naïve.~   "
26568|NCT03219203|"~     This study aims to evaluate the immunologic response to the two hepatitis B virus (HBV)~     vaccination booster strategies in previously vaccinated HIV-infected adults at Maharaj Nakorn~     Chiang Mai Hospital.~   "
26569|NCT03219190|"~     This Fast-Track SBIR project is designed to address the critical need for an effective~     primary prevention approach for prescription drug abuse (PDA), an urgent public health crisis~     in the United States. The project involves developing and testing an innovative new approach~     to the primary prevention of PDA among high school students utilizing e-learning and small~     group facilitator-led intervention modalities. The intervention is an adaptation of the~     evidence-based substance abuse prevention approach called Life Skills Training (LST). The~     adapted intervention will address the relationship between PDA and alcohol, tobacco and other~     drug (ATOD) use and abuse; positively change social norms surrounding ATOD and PDA;~     discourage diversion of prescription medications; enhance protective factors by building~     social and self-regulation skills through interactive learning and behavioral rehearsal~     scenarios.~   "
26570|NCT03219177|"~     There is a current opioid epidemic in the United States partially fueled by excess~     prescribing practices after surgery. The objective of this study is to decrease the amount of~     opioids needed after ambulatory hand surgery. In this randomized control trial, patients will~     be randomized into a patient education group and into a control group. The education group~     will be provided with a pre-operative video detailing proper indications for opioid use after~     hand surgery, alternative pain management strategies to try before using prescription opioid~     medications, and side effects associated with opioid use. Patients will also receive~     information on the current opioid epidemic. Patients will be reminded of the information~     given pre-operatively after surgery in the post-anesthesia care unit. The control group will~     not receive pre-operative education and will only receive standard of care post-operative~     counseling by nursing in the post-anesthesia care unit. All patients will be given a pain~     log, pain medication diary and participate in phone/email surveys to determine number of~     opioid pills taken, pain levels, and satisfaction with surgery. The investigators hypothesize~     that the education group will have decreased opioid intake and increased patient satisfaction~     compared to the control group.~   "
26572|NCT03219151|"~     This research project will evaluate a gamified electronic medication administration record~     (eMAR) system simulator as a mechanism to improve students' learning of medication~     administration in simulated clinical education. The gamified eMAR simulator will be evaluated~     using a pragmatic randomized controlled trial design in order to determine the effectiveness~     of the game as a technology-enabled, online learning intervention.~   "
26573|NCT03219138|"~     Objective neuromuscular monitoring is the gold standard to detect postoperative residual~     curarization (PORC). Many anesthesiologist just use qualitative neuromuscular monitoring or~     unreliable, clinical tests. Goal of this study is to develop an algorithm of muscle function~     tests to identify PORC~   "
26574|NCT03219125|"~     The purpose is to determine in a case-control study if an association exist between bone~     marrow adiposity and fragility fractures in post-menopausal women.~   "
26575|NCT03219112|"~     In this study the clinical relevance of the use of commercially available virtual reality~     games in the rehabilitation of balance will be assessed in children with cerebral palsy. It~     will be investigated how different commercially available platforms (i.e. Xbox One + Kinect~     and Nintendo Wii + balance board) will affect the compensations of children with cerebral~     palsy to preserve their balance. The effect of 1 training session will be assessed as well as~     the effect of a long-term training of 8 weeks.~   "
26576|NCT03219099|"~     A novel methodology was recently developed and validated by the applicants to compute bone~     strength at the distal radius and tibia using second-generation HR-pQCT reconstructions. The~     methodology is expected to improve significantly the assessment of bone fracture risk in~     idiopathic and secondary osteoporosis, but no reference data and no reproducibility data are~     available.~      The objective of the study is the determination of the sex- and age-specific distributions of~     accurate distal radius and tibia strength assessed by HR-pQCT in the Swiss population.~   "
26577|NCT03219086|"~     Prilocaine theoretically could provide faster onset because of its lower pKa (7,7) compared~     to bupivacaine (8,1). The primary objective of this prospective double blind randomized trial~     is to determine block onset of spinal hyperbaric prilocaine compared to bupivacaine, both~     with a small dose of sufentanyl as an additive.The primary hypothesis is that a significant~     larger amount of patients will gain surgical readiness within 8 minutes after spinal~     injection of prilocaine with sufentanyl compared to bupivacaine with sufentanyl. Surgical~     readiness is defined as a sensory block level of T5 tested by loss of cold sensation.~   "
26578|NCT03219073|"~     Transcranial Direct Current Stimulation (tDCS) is a noninvasive brain stimulation technique~     that utilizes low amplitude direct currents applied via scalp electrodes to apply currents to~     the brain and modulate the level of cortical excitability. tDCS applied over the dorsolateral~     prefrontal and motor cortex has been reported to be able to decrease pain sensation and to~     increase pain threshold in healthy subjects and is effective in reducing central chronic pain~     in patients with multiple sclerosis (PwMS.) In spite of the encouraging results of tDCS in~     PwMS, detailed mechanisms accounting for its analgesic effect have not yet been elucidated.~      This will be the first study to determine the effects of tDCS on whole and regional brain~     activity in PwMS with neuropathic pain to identify potential mechanisms of the analgesic~     effects of tDCS. These findings will provide targets for future studies investigating~     different stimulation areas, possible short- and long-term side effects, and specific target~     areas for other precise stimulation techniques such as transcranial magnetic stimulation.~   "
26579|NCT03219060|"~     This study's objective was to test the efficacy, acceptability and feasibility of a~     motivational interviewing (MI) based smoking cessation intervention with nurses.~   "
26580|NCT03219047|"~     The goal of this clinical research study is to use xenograft models to test the effectiveness~     of certain anti-cancer drugs in relapsed (has come back) or refractory (has not responded to~     treatment) mantle cell lymphoma (MCL).~      Xenograft models involve taking a piece of tissue from participant's tumor that was~     previously collected and putting that tissue inside of a mouse in the lab. This allows the~     tumor to grow in the mouse so that researchers can test the effects of certain drugs.~      In this study, researchers will test the following types of drugs in xenograft models:~        -  Drugs that are FDA approved and commercially available for the treatment of MCL~        -  Drugs that are FDA approved and commercially available for other hematological~          malignancies (blood-based diseases)~        -  Study drugs/combinations that are currently being tested in other MCL clinical research~          studies at MD Anderson~        -  Study drugs/combinations that have been previously studied in other MCL clinical~          research studies~   "
26581|NCT03219034|"~     This study will compare the effectiveness of the two leading oral appliances (OAs) designs~     for the treatment of severe obstructive sleep apnea in overweight adults. The effectiveness~     of OAs has come under question since different designs are combined in evaluating treatment~     efficacy, for example when comparing them to continuous positive airway pressure Due to the~     wide range of reported efficacy (53 to 90%), it is of great value to identify the most~     effective design to guide sleep practitioners and patients.~   "
26582|NCT03219021|"~     The aim of the study is to assess arch dimensions among children with surgically repaired~     unilateral cleft lip and palate.~   "
26583|NCT03219008|"~     Major Depressive Disorder is one of the most common mental diseases,which increases~     health-care costs and the financial burden to families and societies. Considering its complex~     clinical symptoms and diversity of comorbidity, depressive disorder's~     recognition，diagnosis，and antihistone are based on symptomatology,which is lack of~     multidimensional diagnosis technique based on clinical pathological characteristics,as well~     as lack of individualized therapy strategy based on quantified evaluation. Besides, other~     physical diseases，such as nervous system diseases, cardiovascular diseases，endocrine~     diseases, have the high comorbidity of depressive disorder. However，there is no precise~     diagnosis technique or standardized therapy strategy. With all those taken into~     consideration,our study is aimed to adopt E-mental health and m-Health to explore~     multi-dimensional diagnosis, individualized therapy and management technique based on~     molecular biology,nerve electrophysiology，and neuroimaging technology etc.~   "
26584|NCT03218995|"~     This is a multicenter, open-label, dose-escalation study to evaluate the safety,~     tolerability, PK, and efficacy of once-weekly IV infusions of eteplirsen in approximately 12~     male patients, ages 6 months to 48 months (inclusive), who have genotypically confirmed DMD~     with a deletion mutation amenable to exon 51 skipping.~   "
26585|NCT03218982|"~     The purpose of this study is to develop and implement a culturally-appropriate intervention~     to reduce stress in Vietnamese dementia caregivers. A pilot intervention will be done to test~     the feasibility and acceptability of the intervention in a community setting. This will be~     done by randomly assigning a family triad (primary caregiver, secondary caregiver, and their~     care recipient) into an active intervention or a control condition and monitoring findings at~     baseline, post-intervention, and at three months.The intervention will consist of multiple~     components -enhanced psycho-education that includes discussion of Alzheimer's Disease (AD)~     and cultural impacts on beliefs about dementia and caregiving, management of problem~     behaviors, facilitation of support seeking, and mindful Tai Chi. A secondary caregiver who~     the primary caregiver identifies as providing him/her with the most support will be invited~     to join all components, but the intervention will be flexible depending on caregivers'~     needs/preferences. The care recipient is not required to join the sessions but will be able~     to if he/she or the family wishes. During the intervention, community partners will provide~     respite care for the care recipient.~   "
26586|NCT03218969|"~     This is an exploratory, double blinded cross-over study of the D1 antagonist ecopipam treat~     patients currently having dopamine agonist induced augmentation in restless legs syndrome.~     Each arm is 6 weeks composed of an unforced titration up to 100mg/day separated by a 2-week~     wash-out period. Efficacy points will include the IRLS, augmentation scales, sleep scales,~     clinical impressions and fatigue/mood scales.~   "
26587|NCT03218956|"~     It is well established that a breast-feeding women need more protein in their diet compared~     to non-lactating women, but how much additional protein is needed remains unclear. There is~     reason to believe that the current Dietary Reference Intake (DRI) recommendations for~     breast-feeding women are too low. To gain better understanding, we plan to study healthy~     breast-feeding women 20 - 45 yrs, between 3 - 5 months lactation and 6 - 8 months lactation.~     We will use the indicator amino acid oxidation technique (IAAO), which is a modern, quick and~     safe research method.~   "
26588|NCT03218943|"~     Background and Rationale :~      Mechanical ventilation is an essential component of the care of patients with respiratory~     failure.Biphasic positive Airway Pressure (BiPAP) and Airway Pressure release ventilation~     (APRV) are relatively new modes of mechanical ventilation which can be used in treatment of~     patients with impaired oxygenation.The effect of using BiPAP and APRV modes on reducing the~     physiological dead space had not been previously investigated. The investigators hypothesize~     that using APRV mode will decrease physiological dead space more than BiPAP mode in the~     mechanically ventilated critically ill patients.~      Objectives :~      To assess the physiological dead space with each mode. To assess lung mechanics during the~     use of the two modes. To assess the effectiveness of ventilation during the use of the two~     modes.~      Study population & Sample size :~      Sixty adult patients more than 18 years old who are mechanically ventilated patients with P/F~     ratio less than 300. This sample size was calculated based on the assumption that APRV will~     decrease dead space by 20% with alpha error 0.05 and power 80%. The mean and Standard~     deviation of the volume of the dead space assessed in a previous study using BIPAP was 40~      Study Design :~      A randomized controlled non-blinded study with cross-over design. In the Trauma and surgical~     ICU at 185-Hospital (Kasr Alainy Hospitals).~      Methods :~      All mechanically ventilated patients in Trauma and surgical ICU at 185-Hospital (Kasr Alainy~     Hospitals) will start on pressure controlled ventilation mode (PCV) with inspiratory pressure~     achieving tidal volume 6-8 ml/kg for 2 hours then they will be randomized into one of the two~     study groups the BIPAP group or the APRV group .~      Possible Risk (s) to study population :~      By adjusting the ventilator parameters properly and continuous monitoring of the patients in~     the study, there will be no risk facing the patients.~      Outcome parameter (s):~      Primary outcome: Physiological dead space will be measured in the two groups after 30~     minutes.~      Secondary outcomes~        -  Physiological dead space after 3 hours.~        -  PO2/FiO2 ratio.~        -  Peak airway and Mean airway pressures.~        -  PCO2 and PH.~        -  Dynamic compliance.~   "
26589|NCT03218930|"~     Antibiotic resistance has become a major threat to global public health. It is driven by a~     multitude of factors, however one of the leading factors is antibiotic prescribing.~     Inappropriate antibiotic use and overuse of broad-spectrum antibiotics can lead to the~     development of resistant strains. Since in Malta the vast majority of antibiotics are~     acquired through prescription, targeting providers' prescribing behavior is an important~     strategy needed to try to curb antibiotic overuse and resistance.~      The aim of this study is to evaluate the effect of a multifaceted social marketing~     intervention in changing general practitioners' (GPs) antibiotic prescribing behavior for~     patients with acute respiratory tract complaints in Malta. This quasi-experimental~     intervention study using an interrupted time series design includes three phases; a formative~     pre-intervention phase, an intervention phase and post-intervention evaluation phase, and~     will last a total of four years.~      During the pre-intervention phase, various stakeholders, including GPs, pharmacists and~     parents will be interviewed in order to get a better contextual understanding of antibiotic~     use in Malta. A 1-year baseline surveillance system will also be set up to collect actual~     diagnosis-specific antibiotic prescribing by GP. This data will, at a later stage, be used to~     measure the change in antibiotic prescribing behavior post-intervention stage. GPs stage of~     behavior change and intention to prescribe antibiotics will also be measure pre-intervention~     using questionnaires based on the theory of planned behavior and the transtheoretical model.~      The intervention stage will last 6 months and will include multiple components, including,~     delayed prescription pads, educational sessions, educational materials for patients and~     distribution of antibiotic guidelines. The intervention will be monitored closely through~     numerous process indicators.~      Following the intervention, GPs' stage of change and intention to prescribe antibiotics will~     be re-measured using the same questionnaire used pre-intervention. Surveillance data~     collection will be also be resumed and will provide data to measure the primary outcome as~     well as additional secondary outcomes.~      The primary outcome of interest is the change in the rate of antibiotic prescribing for~     patients presenting with an acute respiratory tract complaint.~   "
26590|NCT03218917|"~     The purpose of the study is to evaluate if INS1007 can reduce pulmonary exacerbations over a~     24-week treatment period in patients with non-cystic fibrosis bronchiectasis.~   "
26591|NCT03218904|"~     Glycogen storage disease type I (GSD I) caused by deficiency of glucose-6-phosphatase enzyme~     leading to buildup of a complex sugar called glycogen in liver and low blood glucose level.~     Nutritional treatment involves supplying carbohydrates and uncooked cornstarch. Glycosade®~     (modified cornstarch) has shown promise in maintaining normal blood glucose level in GSD I.~     But the difficulty in nutritional treatment is determining the best type of carbohydrate to~     be given to avoid low blood glucose. Thus, there is a need to develop a simple test to~     examine glucose digestion and measure the utilization of different carbohydrates in GSD I and~     healthy controls.~   "
26592|NCT03218891|"~     The purpose of this study is to evaluate the safety and feasibility of cardiovascular~     rehabilitation in Patients with refractory angina, evaluate the effect of cardiovascular~     rehabilitation in patients with angina Refractory, by maximal oxygen consumption (VO2max) and~     global myocardial ischemic load by Stress Echocardiography; To evaluate the presence of~     myocardial injury, caused by physical stress, through ultra-sensitive troponin after sessions~     of aerobic physical activity, evaluating the behavior during the training period; To evaluate~     the effect of rehabilitation on the modulation of sympathetic activity and inflammation,~     muscular blood flow and lipid metabolism; To evaluate of the effect of rehabilitation on~     ventricular function through Stress echocardiography; Detection of ischemic episodes and~     arrhythmias identified during the Rehabilitation sessions through external cardiac monitoring~     (telemetry); Evaluate the quality of life assessment through the SF-36 questionnaire,~     Canadian Cardiovascular Society, the number of symptomatic episodes of ischemia, daily~     sublingual nitrate intake.~   "
26593|NCT03218878|"~     This study seeks to evaluate pregnancy outcomes following hysteroscopic uterine cavity~     expansion surgery for patients with dysmorphic uterine cavities and poor reproductive~     histories. Patients already planning to undergo surgery at the recommendation of their~     physicians will be recruited for participation.~   "
26594|NCT03218865|"~     Evaluation of the effect of a vitamin E coated high flux polysulfone dialyzer on the~     inflammatory state of patients' end stage renal disease and its clinical benefits in terms of~     anemia Objectives : To assess the benefits of a vitamin E coated polysulfone membrane on the~     micro-inflammatory state of chronic dialysis patients Prospective multicenter controlled and~     randomized study Number of patients : 120 patients (60 patients per group)~   "
26595|NCT03218852|"~     This study is an extended follow-up of the study (ClinicalTrials.gov ID:~     NCT01758120)-Treatment of prednisone plus cyclophosphamide may be superior to treatment of~     prednisone alone in patients with advanced-stage IgA nephropathy.~   "
26596|NCT03218839|"~     This study will assess the safety of the PrePex device as applied to HIV positive men by~     assessing the rate of clinical adverse events. The study will include adult, HIV + men who~     are eligible to receive the PrePex procedure per the Zimbabwe Ministry of Health and Child~     Care (MOHCC) eligibility criteria.~   "
26597|NCT03218826|"~     This phase I trial studies the side effects and best dose of PI3Kbeta inhibitor AZD8186 when~     given together with docetaxel in treating patients with solid tumors with PTEN or PIK3CB~     mutations that have spread to other places in the body or cannot be removed by surgery.~     PI3Kbeta inhibitor AZD8186 may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways~     to stop the growth of tumor cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Giving PI3Kbeta inhibitor AZD8186 and docetaxel~     may work better in treating patients with solid tumors.~   "
26598|NCT03218813|"~     Background Medication adherence following acute coronary syndrome (ACS) is often sub-optimal~     and is associated with poor clinical outcomes. Patients' beliefs about medications have been~     shown to predict poor adherence and may be targetable for intervention. Findings novel ways~     to improve adherence is an important area of research with widespread clinical implications.~     Pharmacists may currently be underutilised in promoting and monitoring medication-taking~     behaviour. There have been few effective interventions led by pharmacists to support~     medication adherence in patients with ACS.~      Objectives This study follows on from a feasibility and acceptability study recently~     conducted (NCT02967588). The primary objective is to pilot a pharmacist-led hospital-based~     intervention to support medication adherence following an ACS.~      Methods This study will adopt a non-randomised intervention cohort design (i.e. controlled~     before-and-after (CBA) study). Patients admitted to hospital with an ACS will be recruited~     for this study. Patients must be prescribed medicines for secondary prevention. The study~     will be delivered by hospital pharmacists over two sessions and will target both intentional~     (Session 1) and unintentional (Session 2) adherence barriers. Session 1 will involve~     eliciting and challenging patients' erroneous beliefs about medications. Session 2 will~     involve formulating specific action plans to encourage medication-taking habit formation.~      Outcome Outcome data will be collected at two time points - 6 week and 12 week follow up. The~     primary outcome of this proposed study will be treatment beliefs, measured using the Beliefs~     about Medicines Questionnaire-Specific (BMQ-S) (Horne, Weinman & Hankin, 1999). Our secondary~     outcome will be self-reported medication adherence measured using the Medication Adherence~     Report Scale (MARS-5) (Horne & Weinman, 2002). Depression, medicines-related self-efficacy~     and satisfaction with medicines information provision will also be measured.~      Study timeline Control cohort ('before' group): eligible patients will receive treatment as~     usual (TAU) and will complete all outcome measures (i.e. treatment beliefs, medication~     adherence). Pharmacists will then be trained to deliver the intervention. Intervention cohort~     ('after' group): eligible patients will receive the pharmacist-led intervention and will~     complete all outcome measures.~   "
26599|NCT03218800|"~     Infections requiring intravenous antimicrobial therapy are very common events in patients~     with advanced cancer. Nevertheless, these patients frequently present vascular damages~     becoming extremely difficult to access and maintain intravenous route for hydration and~     nutritional support. In this context, the subcutaneous route could be implemented as an~     alternative route for replacement of fluids, electrolytes and drugs. Few studies have~     evaluated the possibility of using the subcutaneous route for treatment of infections though.~      Patients in palliative care often have infections caused by multidrug resistant bacterial~     such as beta-lactamase producing bacteria. In this context, we hypothesize Ertapenem~     subcutaneously is not inferior to the same drug intravenously for the treatment of urinary~     infections in patients on oncologic palliative care. A non-inferiority clinical trial would~     be adequate and could provide stronger evidence on the possibility of this alternative route~     for antibiotic therapy in urinary tract infections, with important advantages such as greater~     convenience of use.~   "
26600|NCT03218787|"~     XIENCE 90 study is a prospective, single arm, multi-center, open label trial to evaluate the~     safety of 3-month dual antiplatelet therapy (DAPT) in subjects at high risk of bleeding (HBR)~     undergoing percutaneous coronary intervention (PCI) with the approved XIENCE family of~     coronary drug-eluting stents.~      The XIENCE family stent systems include commercially approved XIENCE Xpedition Everolimus~     Eluting Coronary Stent System (EECSS), XIENCE Alpine EECSS or XIENCE PROX EECSS [OUS {Outside~     of United States} only]) of coronary drug-eluting stents~   "
26601|NCT03218774|"~     The purpose of this study is to compare the effectiveness of 2 community intervention~     approaches to maintain community mobility and walking speed in adults with cerebral palsy who~     have previously completed an 8 week course of physical therapy.~   "
26602|NCT03218761|"~     DNA Acetylation can be responsible for significant down-regulation of transcription of the~     Norepinephrine Transporter (NET). NET is an important clearance transporter that removes~     norepinephrine (NE) from sympathetic neuronal synapses. Very low levels of NET can cause~     Postural Tachycardia Syndrome (POTS) or make these patients more susceptible to certain~     medications. Quantified NET messenger RNA (mRNA) levels from a peripheral blood sample may be~     able to assess NET availability, which is simpler than older methods. This has not been~     validated against NET function. In this protocol, the investigators seek to assess whether~     these NET mRNA levels correlate with NET function. The investigators will assess the DHPG~     (NET dependent NE metabolite):NE ratio in POTS patients and control subjects from both plasma~     and urine samples.~   "
26603|NCT03218748|"~     The purpose of the study is to evaluate the feasibility and efficacy of the group-based~     intervention Honest, Open, Proud among soldiers with mental illness.~   "
26604|NCT03218735|"~     The purpose of this study is to compare the incidence of composite neonatal morbidity and~     birthweight >4500 grams among uncomplicated large for gestational age (LGA) fetal growth at~     delivered 37 weeks versus expectant management.~   "
26650|NCT03218137|"~     Unblinded, controlled, non-randomized, mechanistic study to determine whether physiological~     mechanisms underlying PVC are sensitive to adenosine. Twenty subjects undergoing~     clinically-indicated, standard-of-care cardiac electrophysiology study (EPS) procedure for~     PVCs will receive adenosine to learn if their arrhythmias are inducible similarly to~     sustained ventricular tachycardia.~   "
28201|NCT03197857|"~     The aim of this project is to investigate in obese patients the changes induced by bariatric~     surgery on the various components of the physical condition and their postoperative evolution~     following an intervention combining a physical activity program (aquabike vs bicycle) with or~     without protein supplementation.~   "
26605|NCT03218722|"~     Acute traumatic coagulopathy (ATC) is common in severe trauma patients (around 25 to 30% of~     patients with severe trauma) and is associated with increased mortality. ATC is associated~     with fibrinogen and clotting factors deficiencies. Therefore, ATC management relies on early~     administration of fibrinogen and blood products in case of massive transfusion with a 1:1 or~     1:2 ratio between Fresh Frozen Plasma (FFP) and Red Blood Cells (RBC). This strategy relies~     on fast supply of FFP.~      To overcome delay for FFP ordering, transport and defrosting, the PROCOAG study proposes to~     use prothrombrin concentrate complex (PCC) as alternative to treat coagulation factor~     deficiency. PCC is readily available upon hospital arrival. In addition to fibrinogen~     treatment, it is thought that PCC can be efficient in ATC management, while reducing risks~     associated with massive transfusion.~      ProCoag is a randomized, controlled, double-blinded, parallel clinical trial aiming at~     showing superiority of early PPC+ fibrinogen strategy on fibrinogen only strategy for the~     management of patients at risk of massive transfusion.~      Early administration of PPC should optimize patient blood management and therefore reduce~     blood products transfused within the first 24 hours following a severe trauma.~   "
26606|NCT03218709|"~     To evaluate the validity of multi-vitamin-and-minerals intervention on uric acid metabolism~     in hyperuricemic adults.~   "
26607|NCT03218696|"~     The intent of this study is to see how boys and girls aged 1-5 and coughing since 1-2 days~     due to common cold respond to a specific protective cough syrup taken before going to bed for~     one night, with respect to a similar but not specific syrup (placebo). The symptoms evaluated~     include especially cough frequency but also cough intensity, bother, and sleep quality of the~     child and parents.~   "
26608|NCT03218683|"~     This study is a multicenter, open-label, nonrandomized, sequential group, dose-escalation~     study to assess safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of~     ascending doses of AZD5991 in subjects with relapsed or refractory hematologic malignancies.~   "
26609|NCT03218670|"~     A health education program was provided to higher education students aged between 18 and 25~     years. Students were recruited either by posters and leaflets on campus, or during their~     mandatory medical survey at the University Medical Department. The objectives are to assess~     health behavior risk among college student : e.g eating disorders, binge drinking, electronic~     cigarettes and also stress, burnout~   "
26610|NCT03218657|"~     The clinical symptoms of non transfusion dependent non severe aplastic anemia (NSAA) are~     often lighter than that of severe aplastic anemia. Clinical observation is often used and the~     treatment should be given according to the follow-up results of peripheral blood routine and~     the survival condition of the patients. In recent years, a number of studies at home or~     abroad have tended to intervene earlier. The risk of observation and waiting for disease~     progression is higher. Early immunosuppression should be considered. For the treatment of non~     transfusion dependent non severe aplastic anemia, the commonly used treatment regimen is~     androgen combined with CSA. But the investigators find that Levamisole hydrochloride (LMS) as~     a commonly used immunomodulatory drugs may be helpful to improving immune disorder symptoms~     in NSAA patients. Therefore,the investigators are conducting a prospective, randomized~     controlled study to compare the rate, side effects and long-term survival in non transfusion~     dependent patients with NSAA between the androgen+CSA group and the androgen+CSA+LMS group.~   "
26611|NCT03218644|"~     Introduction: Neck pain is among the most common and costly for industrialized societies. It~     is difficult to know the exact structure causing the pain so most are considered as~     non-specific neck pain. There is a correlation between the alteration of craneocervical~     proprioception and neck pain. The evidence for treatment with proprioceptive exercises is~     very limited.~      Objective: To know the efficacy of a proprioceptive exercise program for neck pain and to~     compare its effects with a cervical mobility program.~      Materials and Methods: Subjects between 18-65 years old with traumatic or non-traumatic neck~     pain are included. They will be randomized into two groups of exercises: proprioception or~     mobility, which will be developed over a period of two weeks, every day, with a total of 10~     sessions per patient.~   "
26612|NCT03218631|"~     To assess the pharmacokinetics and relative bioavailability of a single dose of approximately~     0.1 mg/kg of a medium chain triglyceride (MCT) oil oxandrolone solution vs. tablets in a~     small cohort of healthy adults.~   "
26613|NCT03218618|"~     The aim of such study is to compare three different school-based (in nurseries, kindergartens~     and primary schools) interventions aimed at teaching to families how to prevent food choking~     injuries.~      The topic of food choking primary and secondary prevention is placed in a more general topic~     regarding food safety, including education on food labeling and on food waste prevention.~   "
26614|NCT03218605|"~     Previous studies have shown that a decreased blood flow is a risk factor in the occurrence of~     Achilles tendon (AT) injuries. Based on the current literature, no consensus was reached as~     to the most solid warming-up of the AT. Therefore, knowledge about activities which increase~     blood flow in the AT could be useful in the development of a solid warming-up programme for~     the AT. The aim of this investigation was to define the influence of different kinds of~     physical activity on the vascularisation of the AT in a healthy asymptomatic population.~     Subjects performed five activities in randomized order: running, static stretch, dynamic~     stretch, cycling and rope skipping. The vascularisation of the AT of the dominant limb was~     measured with the non-invasive oxygen-to-see (O2C) device. Blood flow was measured before,~     immediately after, five and ten minutes after activity to investigate the duration of the~     vascular response to activity.~   "
26638|NCT03218293|"~     Remote ischemic postconditioning (RIPC) is suggested to protect the cerebral cell against~     ischemia in various settings. However, the effect of RIPC in patients with acute ischemic~     stroke who undergo thrombolysis has yet to be examined. In this single-center, randomized~     controlled trial, we examined the effect of RIPC on the resolution of nerve function~     deficient in response to thrombolysis. Patients in the RIPC group had five cycles of 5‑min~     cuff inflation followed by 3‑min deflation to the bilateral upper arm after thrombolysis. The~     primary endpoint was the recovery of nerve function deficient assessed by National Institutes~     of Health Stroke Scale(NIHSS), Activities of Daily Living(ADL), Modified Rankin Scale(mRS),~     CT cerebral perfusion imaging (CTP) and CT angiography(CTA). Secondary endpoints included the~     following: angiogenesis assessed by the level of vascular endothelial growth factor (VEGF),~     basic fibroblast growth factor (bFGF).~   "
26615|NCT03218592|"~     Purpose: Perform a 3-phase (single dose, multi dose, dose proportionality) study in healthy~     volunteers using daily tenofovir+emtricitabine, dolutegravir, and maraviroc dosing to~     quantify intra- and inter-subject variability and dose proportionality. The influence of~     covariates on ARV hair distribution (e.g., hair growth rate, race, hair color, hair~     treatment) will also be measured. Using both population PK modeling and physiologic based PK~     (PBPK) approaches, a statistical model to quantify ARV adherence patterns based on signal~     intensity/pattern will be developed.~      Participants: Healthy volunteers, aged 18 to 70 years of age, inclusive on the date of~     screening, with an intact gastrointestinal system and at least 1cm caput hair.~      Procedures (methods): Participants will be sequentially assigned to enroll in a dosing arm,~     beginning with maraviroc, then dolutegravir, and ending with tenofovir/emtricitabine. All~     participants will take a single observed dose of study product in Phase 1, with blood and~     hair samples obtained on Days 3, 7, 14, 21 and 28 days post-dose. In Phase 2, all~     participants take 28 days straight of daily dosing, observed, of the same study product.~     Blood and hair samples obtained on the same days post-dose. In Phase 3, participants will be~     randomized to stop their drug, or decrease dosing to one or three doses weekly. Hair and~     blood samples will again be obtained on the same days post-dose. All participants will~     complete a follow-up safety visit with 14 days of completing study sampling.~   "
26616|NCT03218579|"~     The investigators would like to examine the extent of gut microbiome rehabilitation in~     healthy people after the consumption of antibiotics.~      Outcomes of probiotic treatment versus bacteriotherapy will be compared.~   "
26617|NCT03218566|"~     To determine the safety and efficacy of the Indigo Aspiration System for aspiration~     mechanical thrombectomy in patients with acute submassive pulmonary embolism (PE)~   "
26618|NCT03218553|"~     Postoperative complications are major healthcare problems and are associated with a reduced~     short-term and long-term survival after surgery. Major surgery is associated with a~     predictable and usually transient Systemic Inflammatory Response (SIRS), depending on the~     magnitude of the surgical trauma. An excessive SIRS syndrome participates to the development~     of postoperative organ dysfunction, infection and mortality. Corticosteroids may decrease the~     postsurgical SIRS in cardiac surgery: in a large multicenter randomized trial, a single~     intravenous administration of high-dose dexamethasone did not reduce the incidence of a~     composite endpoint of adverse events but was associated with a reduced incidence of~     postoperative pulmonary complications and infections and with a reduction in hospital stay.~     However, a similar study, recently published in the Lancet was negative. Evidences from one~     meta-analysis, including 11 studies of moderate quality (439 patients in total), suggest that~     intraoperative administration of corticosteroids during major abdominal surgery decreases~     postoperative complications, including infectious complications, without significant risk of~     anastomotic leakage. At present, no large randomized controlled trial has been performed in~     patients undergoing major non-cardiac surgery. In acute medicine, several lines of evidence~     have shown that low to moderate doses of corticosteroids decrease the excessive inflammatory~     response, without inducing immuno suppression. However, despite the widespread use of~     corticosteroids to reduce postoperative nausea and vomiting and to improve analgesia,~     concerns continue to be raised about their safety, especially regarding an increased risk of~     postoperative infection.~      We hypothesize that the perioperative administration of glucocorticoids would reduce~     postoperative morbidity after major non-cardiac surgery through dampening of the inflammatory~     response. Given the number of surgical patients for whom the question applies, the study is~     of significant clinical importance~   "
26619|NCT03218540|"~     Hypothesis: Fluid management guided by stroke volume variation (SVV), compared with central~     venous pressure (CVP), guidance results in better clinical outcomes.~      Primary outcomes: Perioperative, up to 48 h postoperative, serum lactate and creatinine~     level.~      Methods: Adult patients undergoing endovascular aortic aneurysm repair (EVAR) will be~     randomized into 2 groups: SVV group managed by SVV guidance and CVP group managed by CVP~     guidance.~      Outcome analyses: Compare serum lactate, creatinine as well as other postoperative~     complications between both groups.~   "
26620|NCT03218527|"~     Ischemic stroke is a leading cause of death and disability worldwide. Atherosclerosis,~     responsible for the 20% of ischemic strokes, is characterized by lipid accumulation in the~     artery wall that leads to chronic inflammation, cell proliferation and ultimately to vessel~     stenosis. One of the main features related to plaque progression and vulnerability is~     inflammation. Positron emission tomography with 18-fluorodeoxyglucos (18-FDG PET) allows an~     accurate quantification of plaque inflammation and it has been proved its usefulness in~     predicting early stroke recurrences. The investigators aim to test how modifiable vascular~     risk factors influence plaque inflammation assessed by 18-FDG PET. In addition, investigators~     will assess the association of this inflammation and circulating endothelial progenitor cells~   "
26621|NCT03218514|"~     The main aim of this study is to compare the influence of total body-weight (TBW), lean~     body-weight (LBW), ideal body-weight (IBW) or Body Mass Index (BMI) on peak anti-Xa levels at~     steady-state in bariatric surgery (BS) morbidly obese patients receiving a fixed double dose~     of dalteparin (5000 IU subcutaneously, twice daily a day) for venous thromboembolism (VTE)~     prevention. Secondary aims of this study are to identify which body size descriptors (BSD)~     has the greatest impact and could further be explored for an adjusted low molecular weight~     heparin (LMWH) dosing algorithm for achieving optimal VTE prevention in BS severely obese~     patients.~   "
26622|NCT03218501|"~     The purpose of this study is to evaluate the efficacy, safety and dose response of SK-1405~     for the treatment of subjects with uremic pruritus receiving hemodialysis, during 2 weeks of~     treatment.~   "
26623|NCT03218488|"~     The purpose of this study is to monitor the long-term safety of ustekinumab in pediatric~     participants (aged greater than or equal to 12 years to less than 18 years inclusive) with~     moderate to severe plaque psoriasis, through monitoring for the following adverse events~     potentially related to immune modulation: serious infections, malignancies and autoimmunity;~     and to monitor the long-term effects of ustekinumab on growth (weight, height, body mass~     index) and development (sexual maturity based on the Tanner Scale).~   "
26624|NCT03218475|"~     Head and neck cancer is the sixth most common form of malignancy world-wide. Surgery,~     chemotherapy and radiation are associated with a high burden of side effects; tumour~     recurrence within the neck continues to be a major cause of treatment failure. To our~     knowledge, this research is the first clinical study in human subjects to utilize magnetic~     resonance guided focused ultrasound to treat cancer of the neck. The goal is to evaluate the~     safety and technical feasibility of this therapy in order to guide future clinical~     applications such as ablation, radiosensitization or drug delivery that could ultimately~     improve clinical outcomes. A total of 10 patients will be treated with MR guided high~     intensity focused ultrasound (HIFU).~   "
26625|NCT03218462|"~     Children with intellectual/developmental disabilities (ID/DD) will experience less dental~     anxiety and cooperate better in a Sensory Adapted Dental Environment (modified visual,~     sensory, and somatosensory stimuli in a regular dental setting) than in a regular dental~     environment (RDE).~   "
26626|NCT03218449|"~     Infective complications after cancer surgery had a significant impact on disease-free and~     overall survival. Postoperative inflammatory markers have been proven useful in predicting~     infective complications. However, it remains unknown whether these markers can predict~     postoperative infection in patients receiving cytoreductive surgery with hyperthermic~     intraperitoneal chemotherapy (HIPEC) which causes the systemic inflammatory response~     syndrome. Between September 2014 and April 2017, all patients who underwent cytoreductive~     surgery and HIPEC for peritoneal carcinomatosis were assessed for postoperative~     complications. Patients were divided into two groups according to the presence of infective~     complications. Presence of abscess, positive blood, surgical site, urine or sputum cultures,~     or clinical signs and symptoms with comparable radiologic findings were defined as infective~     complications. Retrospectively, C-reactive protein (CRP), neutrophil-to-lymphocyte ratio,~     white blood cell count, platelet count, mean platelet volume, platelet-to-lymphocyte ratio,~     albumin were collected from preoperative day and postoperative days (POD) 0-14.~   "
26627|NCT03218436|"~     Cervical intraepithelial neoplasia will be treated with physical low temperature plasma in~     the plasma cohort compared to watchful waiting in the control cohort.~      Primary endpoint after 3-6 months: Pathological remission.~      Secondary endpoint: HPV remission.~   "
26628|NCT03218423|"~     This study will evaluate longitudinal performance of Epi proColon with respect to test~     positivity, longitudinal adherence to Epi proColon screening, adherence to follow-up~     colonoscopy and diagnostic yield, as well as assay failure rates.~   "
26629|NCT03218410|"~     Acute pulmonary embolism (PE) is a serious and potentially lethal condition. The clinical~     spectrum of PE spans from asymptomatic PE to patients with severe hemodynamic compromise. The~     main determinant of outcome is right ventricular dysfunction caused by the abrupt rise in~     pulmonary vascular resistance. Patients with hemodynamic compromise are at highest risk of~     mortality (>15%). Hemodynamic stable patients with imaging and biomarker evidence of right~     ventricular (RV)- dysfunction are at intermediate-high risk of mortality (3-15%). According~     to the European Society of Cardiology (ESC) guidelines reperfusion therapy options for~     patients at high risk and at intermediate-high risk include systemic thrombolysis,~     catheter-directed therapy or surgical embolectomy.~      The University Hospital of Bern is the only tertiary care hospital in Switzerland that has~     established an interdisciplinary pulmonary embolism response team (PERT since 2010) and has~     gained expertise in both catheter-directed thrombolysis and surgical embolectomy. Since the~     introduction of PERT, systemic thrombolysis was no longer performed in Bern due to the high~     risk of intracranial hemorrhage. Favorable clinical outcomes of the patients managed in Bern~     have been published for both catheter-directed therapy and surgical embolectomy.~      To date, no study has ever compared catheter-directed thrombolysis versus surgical pulmonary~     embolectomy in the treatment of high and intermediate-high risk PE patients.~   "
26630|NCT03218397|"~     RAPIDS-GN is a multi-center, prospective, randomized, controlled trial to evaluate the~     following strategies for patients with confirmed gram-negative bacillus bacteremia (GNB):~        1. Standard culture and antimicrobial susceptibility testing (AST); or~        2. Rapid identification and AST using the Accelerate PhenoTest™ BC Kit, performed on the~          Accelerate Pheno™ System (AXDX)~   "
26631|NCT03218384|"~     The purpose of this study is to better understand how body levels of iron affect the ability~     to exercise in patients with heart failure.~      Heart failure is a condition in which abnormal pumping action of the heart reduces the flow~     of blood to the body. Patients with heart failure may feel shortness of breath or leg fatigue~     when they exercise. Iron is an essential nutrient in the diet. In heart failure patients, low~     body levels of iron might increase shortness of breath and fatigue.~   "
26632|NCT03218371|"~     The investigators compared the incidence of trimming-induced retinal breaks, retinal~     redetachment rate, and final LogMAR BCVA; between scleral self-indentation and~     non-indentation during chandelier-assisted peripheral vitrectomy under air for eyes with~     primary retinal detachment. Self-indentation enables complete trimming of the vitreous base~     without causing iatrogenic retinal breaks, with a higher retinal reattachment rate, and with~     less need for chandelier shift than with non-indentation approach.~   "
26633|NCT03218358|"~     intra-abdominal hypertension (IAH) and delirium are serious, high-frequency complications in~     intensive care unit (ICU) patients. The consequences of the complication range from high~     morbidity and mortality to a greater need for nursing care. We hypothesize that there could~     be a correlation between IAH and incidence of delirium.~   "
26634|NCT03218345|"~     Radiofrequency ablation has been used for treatment of solid neoplasms of the liver, lung,~     kidney and adrenal. Recently, EUS-guided RFA has become available and the device allows~     EUS-guided treatment of pancreatic neoplasms. The procedure has been shown to be feasible in~     the porcine pancreas and was used to treat small groups of patients that are not suitable for~     surgery suffering from pancreatic neoplasms.~      The aim of the current study is to perform a multi-center prospective study on EUS-guided~     radiofrequency ablation (RFA) of solid pancreatic neoplasms. The hypothesis is that~     EUS-guided RFA is safe, feasible and effective for treating solid pancreatic neoplasms.~   "
26635|NCT03218332|"~     to examine the relationship between repeated concussions and late decline of brain function.~     In addition, all participants agreeing to participate in the study will be asked to will~     their brains to The Krembil Neuroscience Centre Concussion Project at the Toronto Western~     Hospital with the consent and full knowledge of their families and doctors. However, it is~     possible to participate in the research without agreeing to a brain donation.~      The Project Team is specifically attempting a clinical-MRI-brain tissue research analysis to~     determine the exact mechanism of the damage to brain tissue following repeated concussions.~     This condition is known as chronic traumatic encephalopathy (CTE), and shows an abnormal~     protein in the brain called tau-protein.~   "
26636|NCT03218319|"~     This study evaluates the impact of nephrectomy in renal cancer on blood pressure and renal~     function. The patients will have a follow-up of their blood pressure and renal function until~     6 months after their operation.~   "
26637|NCT03218306|"~     The study is aimed at confronting a surgical pleth index based protocol for intraoperative~     analgesia in a desflurane based general anesthesia for thyroidectomy, versus a standard~     clinical approach. A reduction in analgesic consumption and improvement in hemodynamics are~     expected.~   "
26639|NCT03218280|"~     Critically ill polytrauma patients have a number of physiological disorders secondary to~     trauma, such as systemic inflammatory response (SIRS), adult respiratory distress syndrome~     (ARDS), sepsis, oxidative stress (OS), and finally the multiple organ dysfunction syndrome~     (MODS). Another important aspect in terms of clinical outcome is the energy-metabolic status.~     Numerous studies have shown that implementing antioxidant therapy, capable of reducing the~     expression of pro-oxidative, pro-inflammatory and energetic-metabolic status, the mortality~     rate in critical patients decreases statistically significant. In this research paper, will~     be implemented a multimodal monitoring protocol that covers the use of biochemical, genetics~     and epigenetics biomarkers and the use of non-invasive medical devices to assess and monitor~     critical polytrauma patient. Also will be optimized the antioxidant treatment plan according~     to the needs of each patient.~   "
26640|NCT03218267|"~     Total hip replacement (THR) is the procedure which can improve the quality of life in~     patients with osteoarthritis. However, deficits in static stability and impairment of the~     lower limb efficiency can be observed even several months after procedure. The aim of this~     study was to investigate the static balance of the standing position in patients treated by~     THR.~   "
26641|NCT03218254|"~     Cancer related fatigue (CRF) is the most debilitating problem for patients with~     haematological cancer. CRF severely reduces quality of life (QoL), functional capacity,~     impacts health behavior, recovery and furthermore no approved treatment exists. In solid~     cancer methylphenidat (MTP) has been suggested to improve CRF, however patients with~     haematological cancer has not been studied. The current randomized placebo controlled study~     includes a variety of severely fatigued haematological cancer patients from seven Danish~     departments. It aims at revealing whether MTP can improve CRF, functional capacity and QoL~     thereby hopefully providing improvement and treatment options in this field where~     improvements are requested the most by patients. Patients are randomized to treatment with~     MTP or placebo week 1-6 followed by wash-out and cross-over - placebo to MTP or vice versa~     - during week 8-13. End-points will be patient reported fatigue, as well as improvements in~     active hours, functional capacity, and QoL.~   "
26642|NCT03218241|"~     This is a single center, double-blind, randomized, placebo-controlled, ascending, single dose~     study of PRT064445 or its matching placebo, in healthy subjects.~   "
26643|NCT03218228|"~     The aim of the present study is to evaluate the health of immediately placed dental implants~     in aggressive periodontitis patients versus those placed in periodontally healthy individuals~     in the maxillary esthetic zone.~   "
26644|NCT03218215|"~     Background Mechanical assistance cough for patients with neuromuscular disorders (NMD) are~     known, but there is no adaptation model established. Currently is performed subjectively by~     the physiotherapist following the pressures recommended in the current literature as optimal~     (±40CmH2O). To check is these pressures are the most optimal pressures to achieve the better~     peak cough flow (PCF) monitoring cough assist (Mechanical insuffllation-exsuflattion MI-E)~     maneuvers and analyzing pressure- flow / time curves~      Adults with MI-E criteria (PCFbaseline <160 l /min). A pneumotachograph, PeakAnalysis~     software and nasobucal mask were used to monitor and analyze flow/time curves. Protocol~     included 9 PCF values in each patient: 1 baseline, 4 related with inspiratory pressure in~     sequential increase of 10 cmH2O (10 to 40 cmH2O) and 4 adding expiratory pressures (±10 to~     ±40cmH2O)~   "
26645|NCT03218202|"~     Two thirds of patients with Crohn's disease require intestinal surgery at some time in their~     life. Intestinal strictures, that is narrowing of the bowel due to inflammation and scarring,~     are the most common reason for surgery. Despite the high frequency, associated disability,~     and cost there are no are no treatment strategies that aim to improve the outcome of this~     disease complication. The STRIDENT (stricture definition and treatment) studies aim to~     determine biochemical and imaging features associated with the development of strictures and~     in related STRIDENT studies develop strategies for treatment.~   "
26646|NCT03218189|"~     The World Health Organization (WHO) has developed a model list of more than 400 medicines and~     recommends that each country adapt the list to its own circumstances. More than 100 countries~     have developed essential medicines lists.~      Some countries have essential medicines lists that are very similar to the WHO's model list~     and other countries have lists that are very different from the WHO's model list. Differences~     between the WHO list and country lists could be explained by features of the country~     including population demographics, disease prevalence, Gross Domestic Product (GDP), and~     healthcare system organization. Other factors such as the influence of particular individuals~     or organizations may also explain differences between countries.~      The purpose of this project is to compare the essential medicines lists developed by~     countries with the WHO's model list and to identify attributes of countries that are~     associated with differences from the WHO list. Predictors such as region, population, life~     expectancy, infant mortality rate, GDP per capita, health expenditure per capita, inequality,~     and the corruption perception index will be considered.~   "
26647|NCT03218176|"~     A tourniquet is used to stop abundant bleeding when simple compression is not effective. The~     investigators will study the vascular suffering of the tourniquets according to their~     location on the limb: limb (arm / thigh) or distal (forearm / leg). Vascular suffering will~     be evaluated by the loss of the radial doppler flux for the tourniquets placed on the upper~     limb and in the tibial anterior to the lower limb by the loss of the pulse oximetry pulse and~     the collection of the signs described by the volunteers (pain, Paresthesia, cold sensation).~   "
26648|NCT03218163|"~     Determine the progression free survival of high-risk or relapsed Multiple Myeloma (MM)~     patients undergoing non-myeloablative bone marrow allogeneic transplantation (NM-AlloSCT)~     followed by maintenance therapy with MEDI-551.~   "
26649|NCT03218150|"~     Prospective, comparative, observational study.~      The project's aim is long term follow up of patient's having skull bone defects due to~     traumatic or lesion resection causes, treated , in standard clinical practice, with~     autologous bone graft , bone cement or titanium mesh and to compare the clinical outcome and~     safety among the 3 types of treatment.~      Eligibility to each treatment will respect the standard clinical practice.~      Primary outcome: minimize post operative infection~      Secondary outcomes: decrease operation time , clinical and psychological improvement of the~     patient, decrease the cost on the patient~   "
28202|NCT03197844|"~     The purpose of this study is get to know what and how Xinyuan capsule in hospital results in~     drug-induced liver injury or adverse drug reactions from a cohort event monitoring as~     registration research.~   "
26651|NCT03218124|"~     The study is aimed at determining the remifentanil effect site concentration suppressing the~     cough at extubation after surgical thyroidectomy, performed under remifentanil/desflurane~     based general anesthesia, expressed as median and 95th percentile effective dose.~      Possible hemodynamic instability, respiratory depression or prolongation of awakening time~     are also sought.~   "
26652|NCT03218111|"~     This study is being done in order to see how gadolinium-based MRI contrast (Magnevist)~     travels through the central nervous system (CNS) when injected through the spinal column, and~     to compare differences between two age groups (age 20-50, and 51-80). This will allow~     investigators to evaluate how much contrast has crossed into the tissue surrounding the~     brain. Such information will help investigators determine whether this kind of contrast can~     be used to model how other drugs might travel through the CNS and evaluate its use as an~     illustrative imaging marker that mirrors the glymphatic system.~   "
26653|NCT03218098|"~     Post-Operative Pain After Uniportal Vats Lobectomy: Does A Smaller Incision Result In Better~     Recovery?~      Postoperative pain control remains one of the most common problems after major lung~     resection. Pain is considered a major independent factor responsible for increased~     perioperative morbidity and mortality: in particular, in patients with preoperative~     compromised clinical conditions. In fact, acute pain may compromise the patient's~     mobilization and the secretion's clearance with secondary possible bronchial obstruction and~     parenchymal lung infection.~      Today, the treatment of postoperative pain after lung resection is based on association of~     the pharmacological therapy, including systemic use of opioids and non-steroid drugs,~     epidural analgesia, intercostal nerve block and cryoanalgesia with the minimally invasive~     surgery, like use of mini-thoracotomy, a thoracoscopic approach or intercostal nerve~     protection with the use of muscle sparing. In the literature, reduced tissue damage~     consequent to the use of limited surgical approaches is reported to be significantly~     effective in decreasing early postoperative pain. Thus, the use of a minimally invasive~     surgery for lung resections has proved to produce more tolerable pain and allow quicker~     functional recovery and lower postoperative complications. The aim of this prospective~     randomized study was to evaluate the equivalency of a smaller incision (4 cm) when compared~     to a longer length (8 cm) of incision performing uniportal VATS lobectomy in terms of~     postoperative pain results. Primarily, to evaluate the differences of operative time between~     the groups.~      Secondly, to investigate the differences of pain scores between the two groups and the impact~     of pain reduction on functional results.~   "
26654|NCT03218085|"~     Cervical biopsies will be collected from women aged 18 and over whom are virally suppressed~     and taking tenofovir as part of their antiretroviral therapy regimen. Blood plasma,~     peripheral blood mononuclear cells (PBMC), and cervicovaginal swabs will also be collected.~     Drug concentrations, hormone concentrations, inflammatory cytokines, and vaginal microbiome~     will be evaluated to understand the role of hormones, inflammation, and the microbiome in~     modulating drug efficacy in the female genital tract.~   "
26655|NCT03218072|"~     To evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of HLX01 (a potential~     rituximab biosimilar) in patients with CD20-positive B-cell lymphomas.~   "
26656|NCT03218059|"~     Cesarean scar pregnancy (CSP)is one of the more serious complications of pregnancies that~     occur after a prior cesarean delivery. No clinical guidelines have been issued for the~     management of CSP. More than 30 treatment methods are reported to be used in managing CSP.~     However, which management can achieve better clinical effects remains unknown. Therefore,~     this prospective study is designed to compare the outcome between MTX + transvaginal surgery~     and UAE + D&C in the treatment of CSP.~   "
26657|NCT03218046|"~     Tinnitus may be considered as a form of phantom auditory sensation and as such parallels may~     be drawn with other forms of phantom sensation, such as the sensation of pain in an amputated~     limb (phantom limb pain). There has been recent interest in the use of eye movement therapies~     to treat patients with phantom sensations such as these. The role of eye movements in the~     propagation and maintenance of tinnitus has also been well established. The main aim of this~     study is to evaluate the effectiveness of an established form of eye movement therapy called~     Eye Movement Desensitisation and Reprocessing (EMDR). This research is important as EMDR has~     produced encouraging results for other forms of phantom sensation and current models of~     tinnitus fit well with the proposed mode of action of EMDR. Tinnitus is very prevalent in our~     population and is often associated with significant discomfort; however, there is a severe~     lack of effective treatments based on well designed clinical trials. The investigator wishes~     to assess the usefulness of EMDR against the current treatment that is available in many~     institutions including the Investigator's own. The Investigator intends to recruit 15-30~     patients initially to run a pilot study, before embarking on a larger scale study. The~     Investigator hopes that this pilot study will run over the course of a year. If this study~     demonstrates a significant improvement in tinnitus in patient undergoing EMDR, this will be~     an important step forward not only for treating patients with this disorder, but also for~     understanding the pathways that initiate, propagate and maintain tinnitus perception.~   "
26658|NCT03218033|"~     The goal of this study was to examine the effect of an online educational program with and~     without a social media experience.The primary goal of this study was to determine whether~     medication adherence would be improved by having adolescents and young adults with systemic~     lupus erythematosus participate in an online educational website, with or without a social~     media experience. The secondary goal was to determine whether secondary outcomes such as~     quality of life, stress, and self-efficacy improved in this model, and whether these changes~     were associated with improvements in medication management.~   "
26659|NCT03218020|"~     Increased iron load could be a risk factor for cardiovascular diseases (CVD). Red meat~     consumption affects iron status and has also been shown to be related to increased CVD risk.~     The investigators hypothesized that risk associations between red meat intake and~     cardiovascular disease risk can to some degree be explained by higher iron load among~     individuals with higher meat intake. Thus, the investigators evaluate associations between~     red meat consumption, iron status, and CVD risk in a large-scale population based study, the~     European Prospective Investigation into Cancer and Nutrition (EPIC) - Heidelberg.~   "
28203|NCT03197831|"~     The Patient Protection and Affordable Care Act (PPACA) came into law in 2010. Originally,~     according to the Act, a state would lose its federal Medicaid funding if it did not expand~     its Medicaid eligibility to include all persons earning below 138% of the federal poverty~     level on January 1, 2014. However, in a Supreme Court Case in 2012 this was ruled as~     unconstitutional and Medicaid expansion in 2014 was made optional. Twenty four states and the~     District of Columbia opted to expand their Medicaid programs on January 1, 2014 and the~     remaining 26 states opting against it. Section 1115 of the Social Security Act allows states~     to alter the federal Medicaid requirements to promote the overall state Medicaid program.~     Among those states that expanded Medicaid Arkansas, Arizona and Iowa adopted approved Section~     115 Waivers to expand their Medicaid programs. The variability in the states' decisions~     regarding Medicaid expansion presented researchers with the opportunity to study the impacts~     of Medicaid expansion on various facets of health care.~      There is a growing body of evidence suggesting that implementation of the coverage expansions~     under the PPACA and Medicaid expansion led to significant decreases in rate of uninsured~     persons, increase in access to health care and improvements in affordability of healthcare.~     Along with improving access and affordability of health care, the PPACA aimed at reducing the~     growth rate of health care expenditures by reducing wasteful use of resources such as~     preventable inpatient and emergency department (ED) visits. According to previous research,~     access to primary care and insurance coverage are significantly and negatively associated~     with experiencing preventable inpatient and ED visits. Historically, racial/ethnic minorities~     have had lower rates of access to primary care and insurance and higher rates of preventable~     inpatient and ED visits which might change with implementation of PPACA. Within states that~     have expanded Medicaid, adopting different methods of expansion may also impact patterns of~     inpatient and ED utilization and disparities in those. In the current political scenario and~     looming uncertainty over the future of PPACA and the possibilities of modifying the PPACA it~     might benefit policy makers to gain knowledge on the early impact of Medicaid expansions and~     different approaches to expanding Medicaid under the PPACA. This study seeks to determine the~     impact of Medicaid expansion and different types of Medicaid expansion on overall and~     preventable inpatient and ED utilization and disparities in those through a three-state~     comparison between Kentucky, Arkansas and Florida.~      Another major reform under PPACA was in the area of substance use disorder treatment. Despite~     the high societal burden exerted by patients with substance use disorders treatment rates~     among them have been low. The most common reasons cited for the poor access to treatment have~     been lack of insurance coverage. The PPACA required all insurance plans sold after January 1,~     2014 to cover substance use disorder treatments. Additionally, plans were required to cover~     screening, brief intervention and referral to treatment for substance use disorders. This~     might potentially lead to changes in treatment rates and sources of payments for substance~     use disorder treatment. Further, the promotion of integration between substance use disorder~     treatment and primary care might lead to increased referrals by healthcare professionals to~     substance use treatment. Thus, in this study we also seek to assess the impact of Medicaid~     expansion on admission to substance use disorder treatment facilities and changes in sources~     of payments and rate of health care referrals to those treatment facilities.~   "
30318|NCT03170206|"~     This trial is being conducted as a possible treatment for lung cancer with a specific change~     in the KRAS gene.~      The drugs involved in this study are:~        -  Palbociclib~        -  Binimetinib~   "
26660|NCT03218007|"~     One proposed strategy is the stratification of troponin-negative patients with biomarker~     testing at presentation to facilitate the clinically-appropriate rapid discharge from the~     emergency department of patients who present with low-intermediate risk chest pain, and~     conversely to triage appropriate Non sustained ST elevation acute coronary syndrome~     (NSTE-ACS) patients to Cardiology beds, stress and non-invasive imaging modalities.~     Biomarkers such as high-sensitivity troponin (hs-cTn), heart-type fatty acid-binding protein~     (H-FABP), CRP, brain natriuretic peptide (BNP); and copeptin and ischemia-modified albumin~     are an important advance for diagnostic testing for ACS (4). Regarding novel biomarker~     testing at presentation, the addition of these biomarkers demonstrated increased sensitivity~     at an acceptable QALY threshold, but more evidence is needed (5,6). A reliable method for the~     diagnosis of minimal cardiac ischemia would meet a strong demand for the sensitive diagnosis~     of coronary artery disease in patients with chest pain but unremarkable ECGs and biomarkers.~     Adenosine is an endogenous nucleoside cardioprotective agent. Its cardiovascular effects are~     mediated throught the activation of A2A Receptor (A2 AR) and play a major role in the~     regulation of Coronary flow CF. As altered coronary blood flow occurs in patients with CAD,~     it has been showed that that A2AR expression and functional activity play a role in CAD. In a~     previous studies the team have developped an agonist-like monoclonal antibody to study~     expression level of this receptor and their functional activity. Recently , Gariboldi~     demonstrated that measuring the expression level of A2AR on peripheral blood mononuclear~     cells ( PBMC) represents a good tool to address in situ expression in coronary tissues of CAD~     patients.~   "
26661|NCT03217994|"~     The present study investigates whether it is possible to achieve equally satisfactory results~     between 37.5% hydrogen peroxide gel and 6% gel for teeth bleaching. A prospective,~     double-blind, randomized clinical trial was carried out. A total of 33 patients were selected~     from the clinic of the Faculty of Dentistry at the University of Chile. The patients included~     men and women over 18 years old without prior tooth whitening treatments, tooth decay, or~     restorations of the upper front teeth. The patients had tooth colors of A3 or less according~     to the Vita Classical scale, which was determined with a Vita Easy® Shade spectrophotometer.~     The study was carried out with a split-mouth design. One side of each mouth was randomly~     treated with 37.5% hydrogen peroxide, and the other side was bleached with 6% hydrogen~     peroxide. Each group received 3 to 12 minutes of treatment with the respective gel~     applications. Two sessions of bleaching were carried out each week. Color was assessed at 7~     different sessions for 3 months. The spectrophotometer was used to measure the total~     variation of color (ΔE) between the baseline (session 1) and different measurement times~     (sessions 2-7). We compared ΔE for both agents using the Mann-Whitney test.~   "
26662|NCT03217981|"~     Research in the databases Lilacs, BIREME, SciELO by the terms: systemic inflammatory response~     syndrome (SIRS), sepsis, severe sepsis and septic shock and their equivalents in the English~     language. Selection of the main articles of the last five years to study and contextualize~     the reality presented since the implantation of the HUVR sepsis protocol. Statistical~     analysis of data since the implementation of the sepsis protocol in the HUVR, in July 2014~     until June 2016.~   "
26663|NCT03217968|"~     The purpose of this study is to investigate the efficacy of the Cefaly® Abortive Program~     device used at home for 2 hours to treat a migraine attack. This open clinical trial will~     study the abortive treatment of migraine using the Cefaly® Abortive Program device, prior to~     development of a sham-controlled trial.~   "
26664|NCT03217955|"~     Rationale: There is growing consensus that targeting negative symptoms such as social~     withdrawal is essential to be able to preserve social participation, thereby reducing the~     high yearly costs of schizophrenia. Aaron T. Beck, founder of Cognitive Behavioural Therapy~     (CBT), and colleagues have developed and investigated a new CBT approach, in which they~     target inactivity in a chronic schizophrenia population with severe negative symptoms The~     therapy is based on accumulating evidence that dysfunctional beliefs in conjunction with~     neurocognitive impairments can impede social functioning. These results suggest that CBT can~     be highly successful in establishing clinically meaningful improvements. However, the therapy~     has not yet been investigated in a recent-onset population.~      Objective: To evaluate the applicability and (cost-) effectiveness of a shortened, partly~     group based, Cognitive Behavioural Therapy focussing on social activation (CBTsa) in patients~     with recent onset schizophrenia.~      Hypotheses: 1) the investigators hypothesized that CBT focused on social activation (CBTsa)~     in a recent-onset population will result in a substantial reduction in severity of negative~     symptoms, in particular social withdrawal.~      2) The investigators expected that CBTsa would lead to an improvement in terms of Quality of~     Life and overall functioning.~      3) The investigators expected this intervention to result in a reduction in need for care and~     QALY gain as a consequence of improvement in symptoms and social functioning.~      Study design: Single blind randomized controlled trial with 6 month-follow up. Study~     population: Patients between 18 and 35 years old with negative symptoms of at least moderate~     severity, and who have been recently (< 2yrs) diagnosed with schizophrenia.~      Intervention (if applicable): Individual and group-based CBT intervention targeting social~     withdrawal.~      Main study parameters/endpoints: Change in negative symptoms, Social functioning, and quality~     of life, Productivity losses.~   "
26665|NCT03217942|"~     The purpose of this study is to investigate and determine the time course and distribution on~     muscle hyperalgesia and muscle pain in a repeated, low dose NGF model. It is hypothesized~     that low dosages i.m injections of NGF are able to induce mechanical hyperalgesia and muscle~     soreness in a same manner (effect of duration) as for dosages previously used in NGF studies.~     Furthermore, it is also speculated if several injections of low dose NGF into the muscle~     combined are able to course immediate pain sensation and spreading of muscle~     hypersensitivity.~   "
26666|NCT03217929|"~     Background: Obesity is one of the most important diseases around the globe; with a continuous~     increase and public health concern. Current treatments present some limitations. Craving is a~     symptom usually noticeable and has been described as a strong desire or urge to use,~     especially with foods. The vagus nerve and its relations to the neurocircuitry of the reward~     system play essential roles in food intake regulation and this can be done transcutaneously~     trough the auricular branch of the vagus nerve (taVNS). Based on the neurobiology of food~     craving and on the initial data on taVNS demonstrating safety and efficacy in open-label and~     randomized sham controlled trials, the investigators propose the first randomized, sham~     controlled, triple-blind trial on taVNS for food craving in obesity.~      Methods: This will be a two-arm, triple-blinded, randomized controlled trial with 54 subjects~     with food craving assigned to either: 1) a 10-session treatment protocol of real taVNS, or 2)~     a 10-session treatment protocol of sham taVNS, besides qualitative electroencephalogram~     (qEEG) and heart rate variability (HRV). Participants will be evaluated for primary outcome~     measures (Food Craving Questionnaire - State [FCQ-S] and Food Craving Questionnaire - Trait~     [FCQ-T]) before and after intervention, with a follow-up visit of 30 days after the end of~     treatment. A comparison between sham and active groups will be performed in three occasions~     [baseline (T1), at the end of the stimulation protocol (T2) and 30 days after the last day of~     stimulation (T3)].~      Discussion: Given the epidemiological situation and economic and social burdens, the~     possibility of modulating the reward system neurocircuitry trough the vagus nerve with an~     easy-to-use, low-cost, safe and potential at-home use could represent a breakthrough in~     treating obesity. The investigators hypothesized that food craving in obese individuals would~     decrease at least 50%, as well as their intake of high fat, high sugar and processed food,~     commonly described as palatable foods. Beyond that, the investigators expect that these~     individuals would improve anxiety symptoms.~   "
26667|NCT03217916|"~     we found different pattern of podocyte glycoproteins and kidney injury biomarkers in urine~     specimens between preeclampsia and pregnancy complicated with chronic hypertention compared~     with normotensive pregnant controls.abnormally elevayed urine biomarkers in severe~     preeclampsia were completely or prtially reduced 6-8 weaks after delivery to levels~     comparable with those of normal pregnant subjects.~   "
26668|NCT03217903|"~     Myelodysplastic syndromes (MDS) are the most frequent myeloid neoplasms in Western~     Countries.They mainly affect patients aged 65 years or older. This is a very heterogenous~     group of diseases, which prognosis is evaluated with International Prognosis Scoring System.~     High risk MDS present with high frequency of transformation into acute myeloid leukemia.~     Treatment of high risk MDS often is based on hypomethylating agents, such as 5'-azacytidine~     (Azacytidine), with a complete response in approximativel 20% of cases..~      This treatment is based on 4-week cycles, with daily injection during the first week and rest~     during the 3 next weeks of the cycle.~      Azacytidine efficacy is commonly evaluated with clinical and biological parameters determined~     by the International Working Group 2006. These parameters are usually evaluated after at~     least 6 cycles of treatments.~      There is a response with Azacytidine treatment in 60% of cases, including 40% of partial~     responses and 20% of complete responses. In 40% of patients, there is no response, which~     means that the disases is stable or in progression under therapy.~      In this regard, early evaluation of treatment response is an issue. We want to improve our~     knowledge about early response criteria in Azacytidine-treated high-risk MDS, focusing on SMD~     with excess blasts, which represent 30 to 40% of total MDS.~      Then, the investigator team want to compare DNA methylation profile at diagnosis and after 3~     cycles of Azacytidine treatment.~      Main objective :~      Identify DNA methylation profiles related to response to Azacytidine therapy, after only 3~     cycles of treatment, in high risk MDS with excess blasts.~      Secondary objective :~      Identify at diagnosis DNA methylation profiles that are predicitive of response to~     Azacytidin, in high risk MDS with excess blasts.~   "
26669|NCT03217890|"~     Direct benefit of the research to assess the relationship between cleft lip and / or palate~     (different types) and ABO blood groups.~   "
26670|NCT03217877|"~     The primary objective of the POST-PCI trial is to compare the clinical outcomes of a~     post-percutaneous coronary intervention(PCI) aggressive management strategy of routine~     noninvasive functional testing to a usual-care strategy of symptom-oriented functional~     testing in patients with high risk clinical, anatomical, and procedural characteristics who~     received PCI with contemporary drug-eluting stent and bioresorbable vascular scaffold.~   "
26671|NCT03217864|"~     Hospitalization at home is booming. It is designed to meet the demands of patients and their~     families to continue care at home. It partially solves the problem of the lack of places in~     the long-term care structures and allows to respond to a desire of the health policy to~     reduce the lengths of stay in the hospital. Hospitalization at home is also an alternative in~     the management of chronic patients. Nevertheless, at the moment a certain number of requests~     for hospitalization at home remain unsuccessful or their implementation is complicated. In~     addition, the number of home health care provider has increased significantly in recent~     years. According to the federation of home health care provider, the number of beneficiaries~     increased by 1.7% in 4 years. The home health care provider would support 1,200,000 patients~     per year.~      The objective of the study is to analyze the factors participating in Implementation of a~     return home with a Hospitalization at home or a home health care provider during a return~     home project constructed with the patient and his / her relatives from the services of~     Oncology, oncology, hematology of the University Hospital of Strasbourg.~   "
26672|NCT03217851|"~     Study is cross-sectional and observational with one-time dried-blood spot sample collection~     from persons with laboratory-confirmed uncomplicated Plasmodium falciparum malaria (mixed or~     monoinfection). Samples will be analysed for the presence of molecular markers of resistance~     to ACT partner drugs (gene amplifications and/or other mutations in pfmdr1, gene~     amplifications of pfpm2, and additional mutations which may be identified during the course~     of the trial) in the first instance. Testing to detect additional markers of antimalarial~     drug resistance will also be performed where feasible. Prevalence of mutations will be~     summarized and mapped to provide intelligence on antimalarial drug resistance in the region~     of interest.~   "
26673|NCT03217838|"~     This is a Phase I/II clinical study to determine the maximum tolerated dose (MTD), safety,~     tolerability, pharmacokinetics, and pharmacodynamics of AZD2811 in patients with relapsed~     AML/high risk myelodysplastic syndrome or treatment-naïve patients not eligible for intensive~     induction therapy or allogeneic transplantation. The study was also explore the potential~     clinical activity by assessing anti-tumour activity in patients. The study will be conducted~     in two parts, designated Part A, dose escalation, and Part B, dose expansion~   "
26674|NCT03217825|"~     The principal aim of the study is to demonstrate that Rostafuroxin is able to induce a more~     pronounced reduction of arterial blood pressure respect to Losartan, in hypertensive patients~     carrying at least one of the pre-specified gene mutations. In previous studies has been~     demonstrated that these mutations are able to induce specific alterations inducing an~     increase of sodium (Na) reabsorption at renal tubular level and an increase of arterial blood~     pressure. Pilot studies have demonstrated that Rostafuroxin is able to reduce the impact of~     these alterations, and so directly reverse the increase in blood pressure.~   "
26675|NCT03217812|"~     The purpose of this study is to determine if the addition of daratumumab to~     VELCADE-melphalan-prednisone (VMP) will improve very good partial response (VGPR) or better~     compared with VMP alone.~   "
26688|NCT03217643|"~     It has been recently reported that EATL type 1, but not refractory coeliac disease, strongly~     expressed CD30 and might benefit from brentuximab vedotin. Since the safety profile of the~     combination brentuximab vedotin and CHP is known and since the role of etoposide as part of~     induction regimen is not demonstrated, the investigator will assess the efficacy and toxicity~     of the combination brentuximab vedotin and CHP followed by HDT/ASCT, as frontline treatment~     of EATL.~   "
26779|NCT03216460|"~     Subjects will undergo a 7±1 day outpatient, standard therapy phase during which sensor and~     insulin data will be collected. Subjects or their caregivers will manage their diabetes at~     home per their usual routine using the study CGM and remain on current MDI or pump therapy.~     This will be followed by a 5-day/4-night or from approximately 48 to 72 hours for children~     ages 2.0-5.9 years, hybrid closed-loop phase conducted in a supervised hotel/rental house~     setting.~   "
26676|NCT03217799|"~     The investigators have developed an optical system that measures the coagulation status of~     patients in vivo in a non-invasive manner. The system is based on a small optical sensor that~     emits coherent light into the skin and collects the reflected light from the red blood cells~     in the blood vessels in the skin under the sensor. The sensor is placed on the fingertip, and~     during a brief period of occlusion of blood flow by a small pneumatic cuff, red cell movement~     becomes Brownian in nature and is thereby affected by the viscosity of the blood. In patients~     who have a bleeding tendency, red blood cell movement will be faster, while in patients with~     a hypercoagulable state the red cell movement will be slower. Treatment with anticoagulant~     medications is expected to affect the movement of the red blood cells and these changes can~     be detected by the sensor. The investigators plan to test the device in normal subjects and~     in subjects taking Coumadin, direct oral anticoagulants, antiplatelet drugs and heparin-based~     medications. The investigators will determine whether anticoagulants affect the noninvasive~     measurement and compare the results with standard laboratory tests of coagulation.~   "
26677|NCT03217786|"~     Heart transplantation is an effective life-saving treatment for patients with end-stage heart~     disease. After a transplant, the new heart may develop narrowing in the arteries, causing~     heart failure, heart attacks and abnormal heart rhythms. This condition is known as cardiac~     allograft vasculopathy (CAV). The disease is very common, affecting almost a third of heart~     transplant patients by 5 years after transplant. CAV is a serious problem that causes the new~     heart to fail and is one of the main causes of death after transplant. Early detection of CAV~     is important as treatment options are poor once the disease is established. Currently,~     available techniques to evaluate CAV are limited by poor ability to detect disease early. The~     current tests usually focus on the large heart arteries and do not examine the smaller~     arteries that are also affected.~   "
26678|NCT03217773|"~     This is a prospective randomized controlled trial that aimed to compare the short-term~     clinical outcomes, functional outcomes, costs, and recurrence rates between endoscopic~     submucosal dissection (ESD) and transanal minimally invasive surgery (TAMIS) for early rectal~     neoplasms.~   "
26679|NCT03217760|"~     The aim of this pilot study is to examine the patient's induced stress and the young~     dentist's induced stress, during endodontic treatment. This study is carried out using~     physiologic (cortisol measurement, arterial pressure and heart rate) and psychological data~     (VAS visual analog scale of stress, pain and discomfort, CORAH and HAD Scales) collected from~     patients of Brest University Dental Hospital at various stages of root canal treatment. The~     endodontic treatment is carried out under the usual standards and practices.~   "
26680|NCT03217747|"~     Objectives:~      Primary Objectives:~        -  For Arms D-G, to establish the safety, tolerability, and dose-limiting toxicities (DLTs)~          of different treatment combinations of avelumab when administered in combination with~          checkpoint agonist(s) with or without radiation, or radiation and cisplatin in patients~          with limited, locally advanced or metastatic solid tumors in order to estimate the~          maximum tolerated dose (MTD) and select the recommended phase 2 dose (RP2D).~        -  To correlate pre- and post-treatment CD8 expression with clinical benefit (complete~          response [CR], partial response [PR], or stable disease [SD] for > 6 months).~      Secondary Objectives:~        -  To evaluate the efficacy of the different treatment combinations in patients with~          limited, locally advanced or metastatic solid tumors by assessing objective response~          rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 and~          immune-related RECIST (irRECIST).~        -  To evaluate the efficacy of the different treatment combinations in patients with~          limited, locally advanced or metastatic solid tumors by assessing progression-free~          survival (PFS), duration of response (DOR), and overall survival (OS).~   "
26681|NCT03217734|"~     Assess the efficacy and safety of ADA compared to ADA/MTX in patient with Psoriasis. Compare~     Anti-ADA antibody formation and serum ADA levels in patients on ADA compared with those on~     combination ADA and MTX.~   "
26682|NCT03217721|"~     Neutropenia, defined by an absolute count of polymorphonuclear neutrophils less than~     <1500/mm3, exposes patients to infectious complications that can lead to sepsis or septic~     shock. The mortality risk is higher risk. The recommendations published in 2016 were~     formulated to homogenize the clinical practices to improve the survival.~   "
26683|NCT03217708|"~     The purpose of this study is to utilize non-invasive, easily measurable biomarkers (heart~     rate, skin temperature, sleep, and activity) in the post surgical discharge period to~     identify trends which correlate with improved outcome and early recovery (return to baseline~     activity). These are measured (captured) utilizing a wearable technology (WT) device.~      Return to baseline (RTB) activity for the purpose of this study is defined primarily as step~     count normalization as a surrogate of activity (pre versus post operative step count), and~     heart rate variability normalization back to preoperative baseline. Increased heart rate~     variability has been studied in acute care settings as a marker of poor prognosis. Please~     note that return to baseline is not defined for the pediatric population in the same way as~     adults (which is primarily questionnaire based and not applicable in children).~   "
26684|NCT03217695|"~     Mild traumatic brain injury (mTBI), also known as concussion, is of great concern in the~     youth population, with incidences of injury steadily increasing within the past few years.~     Current Canadian estimates have indicated that the total rate of concussions per 100,000~     increased from 467 to 754 for boys and from 209 to 441 for girls from 2003-2010. As defined~     by the recent Zurich Consensus statement, concussion is a pathophysiological injury induced~     by biomechanical forces, which can be caused by impact to the head, neck or body. In 10-20%~     of youth, concussion symptoms persist in the weeks, months or even years following the~     injury. Consequently, youth with persistent concussion symptoms are unable to fully~     participate in the meaningful activities (e.g. attending school, engaging with friends and~     community) they did prior to the injury and experience a reduced quality of life.~      Persistent concussion symptoms in youth requires an approach that directly addresses the~     rumination and attention to distressful thoughts about their functional performance, while~     still promoting appropriate levels of physical and cognitive demands. Targeting these~     constructs may shift the focus away from symptoms, while building self-efficacy and enhancing~     participation in daily activities. Mindfulness-based yoga (MBY) is a mind-body intervention~     that uses physical yoga poses, purposeful breathing techniques and a focus on being in the~     present moment. MBY encourages participants to develop moment-to-moment awareness of physical~     sensations, emotions, and thoughts, and promotes the cultivation of non-judgemental and~     accepting relationships to personal experiences. In chronic pain, fibromyalgia, mental health~     and now TBI populations, MBY has demonstrated benefits in physical (i.e. increased muscle~     strength, endurance), psychological (i.e. decreased stress, increased self-efficacy),~     cognitive (i.e. increased concentration) and social (i.e. emotional regulation, improved~     mood) domains. Although mindfulness based yoga has been validated as a form of rehabilitation~     in the adult population, its applicability for youth with persistent concussion symptoms has~     yet to be explored. Understanding the impact of a MBY intervention on this population may~     enhance management of persistent symptoms and ultimately, participation in meaningful~     activities.~      In addition to the functional sequelae that ensue following this injury, concussion in both~     the acute and persistent phases is being recognized as a neurophysiological injury.~     Traditional methods of assessment following concussion place emphasis on subjective~     self-report and administration of neuropsychological batteries. These assessments are used in~     an effort to return the youth to activity (i.e school, sport). However, these methods can be~     unreliable as youth have a high incentive to return to play and neurocognitive resolution~     does not necessarily equate to pre-injury function. To augment these measures, an objective~     indicator of neurophysiological stress is needed. Heart rate variability (HRV) is an~     objective, neurophysiological indicator of autonomic nervous system functioning. HRV is~     quantified by measuring the time intervals between heartbeats. Increased variability in heart~     rate (i.e. increased HRV) is seen as healthy neurophysiological function, demonstrating an~     individual's ability to adapt and be flexible to the demands of the environment. Conversely,~     decreased HRV is demonstrative of an individual's reduced ability to respond flexibly to~     their environment. Investigating the impact of persistent concussion symptoms on HRV has the~     potential to enhance our understanding of autonomic nervous system functioning in the chronic~     phases of this injury for an understudied population.~      The specific objectives are to: (1) adapt the MBY intervention protocol to suit the unique~     needs of youth with mTBI (i.e. safety, fatigue), (2) collect data on the impact of MBY on~     HRV, self-efficacy and participation, (3) describe changes in HRV, self-efficacy and~     participation associated with MBY across pre-intervention, post-intervention and 3 months~     following intervention, (4) identify if post concussion symptoms change (i.e. increase or~     decrease) following MBY and (5) identify if changes in post concussion symptoms occur with~     changes in HRV, self-efficacy and participation.~   "
26685|NCT03217682|"~     This is a cohort study where subjects will receive either massage therapy or music therapy~     interventions to evaluate their impact on hospice patients.~   "
26686|NCT03217669|"~     This is a small phase I study with dose escalation and dose expansion cohorts. The former~     cohort will need up to 12 subjects with advanced solid tumor to define feasibility and~     recommended phase 2 dose (RP2D); the latter up to 10 subjects to further define safety. Study~     subjects will be adults with advanced solid tumor (dose escalation) and advanced non-small~     cell lung cancer (NSCLC) who progressed on at least one first-line systemic therapy (dose~     expansion).~   "
26687|NCT03217656|"~     The Jiaxing Birth Cohort (JBC) is the largest prospective cohort study to explore prenatal~     risk factors, early life feeding practice and growth pattern/ adiposity in Chinese~     children.Between 1999 and 2013, 338 413 mother-child pairs were recruited in Jiaxing area in~     south-east China.Children of the recruited women were followed up at 1-2, 3, 6, 9 and 12~     months of age, and subsequently followed up every 6 months to 36 months of age (toddler~     stage), and every year to 6-7 years of age before they went to school (pre-school stage).~     Follow-up rate was 70.8% at the toddler stage and 68.9% at the pre-school stage up to June~     2013.~   "
26689|NCT03217630|"~     This is a prospective cohort study. The main objective is to compare the prevalence of a~     full stomach using gastric ultrasound technique, in elective surgical patients with~     diabetes mellitus compared to non-diabetic controls following the present fasting guidelines~     (2 h after clear liquid and 6h after a light meal). For patients with a full stomach or~     intermediate stomach, an consecutive ultrasound scan is performed every 10 min,until empty~     stomachstomach contents are detected to determine the mean gastric emptying time for clear~     liquid and light meal, and to investigate the risk factors for delayed stomach emptying in~     diabetic patients by logistic regression analysis .~   "
26690|NCT03217617|"~     This is a Phase I/II clinical trial of gene transfer for treating X-linked severe combined~     immunodeficiency (SCID-X1) using a self-inactivating lentiviral vector to functionally~     correct the defective gene(s). The primary objectives are to evaluate the safety and efficacy~     of the gene transfer clinical protocol.~   "
26691|NCT03217604|"~     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of~     single ascending doses of PF-06852231 after first-time administration to healthy adult~     subjects. The safety, tolerability, and pharmacokinetics of an active metabolite~     (PF-06892787) will also be evaluated in this study.~   "
26692|NCT03217591|"~     To evaluate the safety and efficacy of IW-1973 in patients with type 2 diabetes mellitus with~     albuminuria who are on a stable regimen of renin-angiotensin system inhibitors.~   "
26693|NCT03217578|"~     Parents or legal guardian of neonates who signed agreement will receive SMA screening test if~     their neonates are affected with SMA. The dried blood spots of routine newborn screening~     samples will be used to test if neonates have lost 2 copies of SMN1 gene. If neonates have~     positive SMA screening test, further confirmation with multiplex ligation-dependent probe~     amplification (MLPA) test and prospective motor function monitoring including physical and~     neurological examinations will be proved to make SMA confirmation. For any confirmed SMA~     patient, genetic counseling and standard of care will be proved.~   "
26694|NCT03217565|"~     The primary objectives of this study are to describe the single-dose pharmacokinetics (PK) of~     intravenous (IV) tedizolid phosphate or an oral suspension of tedizolid phosphate, when~     administered to pediatric participants, full-term neonates, and preterm neonates.~   "
26695|NCT03217552|"~     This study is a prospective, single center, observational, cohort study of patients to~     determine whether the Mologic Biomarker Panel can identify patients with infection from those~     without, including those with other reasons for inflammation (e.g. post-operative). It will~     also assess whether it has the potential to judge the severity of illness, prognosticate~     outcome and guide antibiotic therapy.~      The aim is to recruit patients who are representative of patients with suspected sepsis,~     uncomplicated infection, or non-infection related critical illness that require critical care~     intervention and assessment.~      This study is observational and will not alter patient management or the standard of care.~     The results from the investigational Mologic Biomarker Panel and associated research assays~     will not be provided to treating clinicians, or used in any manner to affect patient care.~      The study will take place over approximately an 18-month period and it is anticipated that~     approximately 600 patients will be collectively enrolled. The study aims to recruit patients~     from three environments within UCLH:~        -  The Emergency Department.~        -  Critical Care Unit~        -  Patients undergoing major surgery~   "
26696|NCT03217539|"~     Population-based randomized controlled trial carried out in two Swedish counties, Dalarna and~     Ostergotland to find out the impact of early detection on mortality from breast cancer.~   "
26697|NCT03217526|"~     Twenty-four individuals with burn injury will be included in this study. Participants with~     burn injury will evaluate with the following assessment tools: Demographic datas; age,~     gender, height, body mass index; burn caharacteristics; type of burn injury, degree of burn~     injury, localization of burn injury and total burn surface area will be recorded. Gait~     parameters (step length, stride length, base support, step time, cycle time, cadence,~     velocity, single support, double support, swing ( % of gait cycle) and stance (% of gait~     cycle). will be recorded via GAITRite system.~   "
26698|NCT03217513|"~     The purpose of this study is to generate proof of concept human data by evaluating~     osteoarthritis outcome measures in arthritic patients that are prescribed Forteo® as the~     standard of care to treat their primary diagnosis of osteoporosis.~   "
26699|NCT03217500|"~     The purpose of the study is to explore whether femtosecond laser-assisted cornea epithelial~     autograft is more effective than limbal conjunctival autograft for ocular surface~     reconstruction after excision of pterygium.~   "
26700|NCT03217487|"~     The purpose of the study is to explore whether femtosecond laser-assisted corneal epithelial~     autograft is more effective than limbal conjunctival autograft for ocular surface~     reconstruction in patients with limbal stem cell deficiency (LSCD).~   "
26701|NCT03217474|"~     The purpose of the study is to learn if adding femtosecond laser-assisted corneal debridement~     to a standard therapy of oral ganciclovir can help shorten the healing time of herpes simplex~     epithelial keratitis (HSK).~   "
26702|NCT03217461|"~     The purpose of the study is to explore whether femtosecond laser-assisted corneal epithelial~     autograft is more effective than femtosecond laser-assisted limbal autograft for ocular~     surface reconstruction after excision of limbal dermoid.~   "
26703|NCT03217448|"~     This is a single-center, prospective, randomized (1:1), open-label study with two parallel~     groups. This study is planned to investigate the efficacy and safety of dabigatran etexilate~     comparing with warfarin for the treatment of cerebral venous thrombosis.~   "
26704|NCT03217435|"~     The purpose of the study is to explore whether femtosecond laser-assisted corneal epithelial~     allograft from living-related donor is more effective than limbal conjunctival allograft from~     living-related donor for ocular surface reconstruction in patients with limbal stem cell~     deficiency (LSCD).~   "
26705|NCT03217422|"~     VAY736 dose testing; VAY736 efficacy and safety testing.~   "
26706|NCT03217409|"~     A Study to Compare Rosuvastatin/Ezetimibe Combination and Monotherapy in Patients with~     Diabetes Mellitus and Hypercholesterolemia.~   "
26729|NCT03217110|"~     The purpose of this study is to examine whether cerebellar stimulation can be used to improve~     cognitive deficits and mood in patients with schizophrenia, autism, bipolar disorder,~     Parkinson's disease, and major depression.~   "
26707|NCT03217396|"~     A prospective and retrospective cohort study of about five years will be performed on blood~     and cerebrospinal fluid samples taken for diagnostic reasons from recruited patients within~     the Neuromed Neurology Unit. Subjects with other chronic neurodegenerative diseases such as~     Amyotrophic lateral sclerosis (ALS), Alzheimer's disease (AD) and Parkinson's disease (PD),~     and healthy subjects subjected to blood sampling and / or lumbar puncture for clinical~     reasons will be recruited As control groups.~   "
26708|NCT03217383|"~     Obstructive sleep apnea (OSA) is a common disease that is largely un-diagnosed and untreated.~     Standard treatment for obstructive sleep apnea, nasal continuous positive airway pressure~     (CPAP), entails use of a nose mask to deliver positive pressure which dilates the pharynx and~     eliminates obstruction. This therapy is highly efficacious and benign but is associated with~     low adherence, particularly in non-sleepy apneics with disease of mild and moderate severity.~     The principal alternative to CPAP therapy is oral appliance (OA) therapy in which a custom~     made mandibular advancement splint (MAS) is used to protrude the mandible during sleep,~     thereby opening the pharyngeal airway. OA therapy, while preferred and well accepted by most~     participants, is not uniformly efficacious. Additionally, uncertainty regarding the patient's~     response to OAT and the effective target mandibular position can lead to a significant time~     span between diagnosis and initiation of effective treatment. Furthermore, knowledge of the~     effective target mandibular position supports the use of new OA design and manufacturing~     processes that can further reduce the time and cost in delivering the therapy.~      Zephyr Sleep Technologies (the Sponsor) has developed a method of identifying OAT responsive~     participants and their efficacious mandibular protrusion. Recently, Zephyr Sleep Technologies~     developed a portable device that avoids this requirement and can be used in a multi-night~     test in the home. Using a feedback controlled mandibular positioner (FCMP), the device~     measures and analyzes respiratory airflow and oxygen saturation and makes decisions in~     real-time about moving the mandible. The FCMP device was tested in a blinded, bi-phase~     clinical study in which participants with mild-to-severe sleep apnea (n=202) underwent two~     full-night studies in the home. Data from phase 1 were used to develop a predictive method,~     and data from phase 2 were used to prospectively test the accuracy of the predictive method.~     An efficacious mandibular position was also predicted, and each participant was treated with~     a custom oral appliance set to that position. Data from both phases were used to evaluate the~     feasibility of use of the device in the home.~      A random forest machine learning system was used to develop and test the predictive method.~     The overall oral appliance success rate was 76% for phase 1 and 71% for phase 2. The overall~     predictive accuracy was 88%. Values for sensitivity and specificity were 85% and 93%,~     respectively. Positive and negative predictive values were 97% and 72%, respectively. The~     effective target protrusive position was identified in 86% of cases. The studies were~     conducted independently by the participants in their homes, though due to limitations in the~     early prototype design, a clinical coordinator visited the home to set up the equipment prior~     to each night of study. No significant problems were encountered, and no significant risks~     were identified. The results of the clinical trial show that the auto-titrating mandibular~     positioner is suitable for use in the home and accurately predicts OAT outcome as well as~     target protrusive position.~      Based on the results of this study, Zephyr developed a commercially available device which~     has been approved for sale in Canada (Health Canada device license #97614). The device,~     branded MATRx plus, functions as both a sleep recorder as well as a home-based system to~     select patients for oral appliance therapy. This commercially available device is currently~     being used in three separate usability trials to quantify the usability of the device and the~     benefits of an improved workflow through adoption of the new technology in a dental practice.~      Evidence has recently appeared to indicate that the change in pharyngeal volume caused by~     protrusion of the mandible, measured while awake, correlates with the change in~     apnea-hypopnea index (AHI) achieved by OAT, measured while asleep. This is the first~     convincing evidence that an awake measurement of the pharyngeal airway correlates with the~     improvement in respiratory status during sleep induced by an oral appliance. The implication~     is that a simple conebeam CT of the pharynx can predict outcome with OAT. Accordingly, we~     shall carry out conebeam CTs in the research protocol, both at rest position of the mandible~     and at 90% of maximal protrusion.~      The purpose of this study is to test whether the predictive accuracy of the FCMP in the home~     environment is improved by the commercial design and whether patients predicted to be~     suitable for oral appliance therapy have long term adherence.~   "
26709|NCT03217370|"~     The investigators noticed a variable prescription of blood components to haematological~     patients in the hospital. This study will analyze the prescription and administration of~     blood components to Haematological patients (pre measurement). Based on these results~     guidelines on transfusion triggers will be updated and educated to the physicians and new ICT~     (information and communications technology) implementations will be added to the electronic~     order for blood components. The investigators hope to see afterwards (post measurement) a~     more stable prescription and administration of blood components and a more economic use of~     blood components.~   "
26710|NCT03217357|"~     An exacerbated response to stress mediated by activation of the~     Hypothalamo-Pituitary-Adrenocortical (HPA) axis is thought to play an important role in the~     onset, worsening and relapse of schizophrenia. Subjects at risk for schizophrenia (unaffected~     siblings of patients) displayed an intermediate hyperreactivity to stress as compared with~     patients and healthy controls.~      Symptoms of schizophrenia can be reduced with noninvasive brain stimulation (NIBS) applied~     over the dorsolateral prefrontal cortex (DLPFC). Importantly, this same DLPFC NIBS protocol~     can modulate decision making processes and modulate biological reactivity to stress by~     decreasing salivary cortisol concentration in acute stress condition.~   "
26711|NCT03217344|"~     Optimal treatment of proximal humeral fractures is yet to be defined. Many of them can be~     treated non-operatively. The question remains on how long do we have to immobilize~     non-operatively treated proximal humeral fractures?~   "
26712|NCT03217331|"~     This is a Phase 1b/IIa, single centre, non-randomised open-label uncontrolled study to assess~     safety, effect and PK of oral CRD-102 in patients with RHF associated with the presence of an~     LVAD.~   "
26713|NCT03217318|"~     After providing informed consent, patients will be randomized into one of two groups~     (single-blinded): Group 1 will receive a standard Percuflex® (Boston scientific) ureteral~     stent. Diameter: 6F, length according to surgeons' estimation. Patients in Group 2 will~     receive a Suture-Stent adjusted to the individual stone location.~      All participant receive standardized patient information, using a validated leaflet on~     ureteral stenting and associated morbidity.~      In both groups, patients will complete the Ureteral Stent Symptoms Questionnaire (USSQ) 1~     week after stent insertion, prior to stent removal (i.e. 2-6 weeks after insertion) and after~     (2-6 weeks) stent removal. USSQ results after stent removal serve as an assessment of~     baseline symptoms. During secondary stone removal, stents are removed and ureteral~     dilatation / access is assessed.~      The removed stents will be assessed for biofilm formation within the framework of an approved~     and ongoing study on the development of a Biofilm-model (EKSG 15/084). Potential~     complications and adverse events are assessed at all scheduled and unscheduled patient~     visits.~   "
26714|NCT03217305|"~     The study compares two different ventilation modes, Pressure support ventilation vs.~     Neuronally Adjusted Ventilatory Assist, in postcardiac surgery patients. Of special interest~     is shunt and alveolar deadspace and ventral vs. dorsal ventilation.~   "
26715|NCT03217292|"~     Analgesia following video-assisted thoracoscopic surgery (VATS) is important for the~     prevention of postoperative pulmonary complications.Various regional methods of anesthesia~     are currently being used to achieve this goal. The aim of the study was to assess the~     effectiveness of SAPB on postoperative VATS analgesia.~   "
26716|NCT03217279|"~     The incidence of Stroke in France is about 150 000 per year. Stroke represents the leading~     cause of long-term disability. The specificity of stroke is the sequelae polymorphism that~     can occurs: physical disability, cognitive deficit and sensitive trouble. Then this large~     extend of sequelae may have a different impact on daily life. Therefore, we have to consider~     the individual's own resources and in his whole environment to face the situation. We suppose~     that each situation, each post-stroke disability will have a different social impact in~     stroke survivors and their caregivers. Nowadays, Barthel Index and Rankin scale are the~     standards for the assessment of the stroke impact on survivors' daily life. However, what is~     the real impact of an activity limitation in daily life? How consider the psychosocial impact~     of stroke only with functional indicators? For this study we will consider handicap and~     disability in a societal way. In fact, the WHO developed in 2001 the International~     Classification of functioning, disability and health that allows to bring the concept of~     participation restriction, this is to say the consequences of a disability in the real life.~     The ICF allows to bring a conceptual framework of participation restriction.~      Psychosocial consequences of stroke are relatively unknown especially in France. According to~     our hypothesis, patients with major disabilities and their caregivers will experience more~     psychosocial consequences and participation restriction in terms of emotional health, quality~     of life and burden. Also, we hypothesize that stroke severity, the typology of disabilities~     (motor, cognitive and sensorial) will have a different impact on patients and proxys' lifes~     in terms of psychosocial consequences, participation restriction and quality of life.~      TYBRA study is a prospective multicentric cohort study that mixes qualitative and~     quantitative approaches. The first aim of the quantitative approach is to explore factors~     related to patients and their caregivers at 6 months that predict participation restriction~     at 12 months post-stroke. The first aim of the qualitative study is to explore the experience~     of stroke in minor stroke patients and their proxys.~   "
26717|NCT03217266|"~     This phase Ib trial studies the side effects of MDM2 inhibitor AMG-232 and radiation therapy~     in treating patients with soft tissue sarcoma. MDM2 inhibitor AMG-232 may stop the growth of~     cancer cells by blocking some of the enzymes needed for cell growth. Giving MDM2 inhibitor~     AMG-232 and radiation therapy before surgery may make the tumor smaller and reduce the amount~     of normal tissue that needs to be removed.~   "
26718|NCT03217253|"~     This phase I trial studies the best dose and side effect of tazemetostat in treating patients~     with solid tumors or B-cell lymphomas with liver dysfunction that have spread to other places~     in the body or cannot be removed by surgery. Tazemetostat may stop the growth of cancer cells~     by blocking some of the enzymes needed for cell growth.~   "
26751|NCT03216824|"~     Central venous access device (CVAD)-associated skin impairment (CASI) is a common problem in~     allogeneic hematopoietic stem cell transplant (HSCT) recipients. In this prospective~     randomized pilot study, dressing the CVAD exit site will be compared to no-dressing with~     respect to CASI and CVAD-related bloodstream infection (CRBSI) rates in adult outpatient HSCT~     recipients. The purpose of this study is to gain information that can be used to design a~     large randomized controlled trial (RCT).~   "
26780|NCT03216447|"~     A study of patient adherence and convenience to immunosuppressive agents in newly liver~     transplant recipients - a prospective, multi-center, open-labeled, randomized clinical trial~     for comparison between once-daily early conversion and twice-daily tacrolimus formulation.~   "
26719|NCT03217240|"~     Advances in paediatric cardiology and cardiac surgery have enabled the survival of most~     patients born with congenital heart disease (CHD) into adulthood. Many CHD patients have~     undergone palliative or reparative surgery earlier in life. As patients survive into~     adulthood, they may need intervention or surgery for residual haemodynamic lesions. This is~     because they are at risk of arrhythmias secondary to structure heart disease and are~     susceptible to acquired heart disease. In these patients, pre-operative and post-operative~     evaluation of right ventricular (RV) structure (shape and volume) and function is an~     essential component of clinical management.~      Advances have been made in cardiac imaging so that accurate assessment of the right heart~     chamber in terms of its structure, function and physiology is possible. However, this~     technology has as yet never been applied in an effort to comprehensively assess RV structure,~     function and physiology. Cardiac Magnetic Resonance (CMR) will be used in this comprehensive~     assessment of structure and function. Thus, this research will allow development of a~     comprehensive integrated biomedical engineering (BME) R&D platform for in-depth study and~     clinical diagnosis of the RV structure-function relationship and physiology and its~     association with biomarker, and exercise capacity in CHD.~   "
26720|NCT03217227|"~     Ischemic Heart Disease (IHD) is a condition of recurring chest pain or discomfort that occurs~     when a part of the heart is not receiving sufficient blood flow. It is a major public health~     concern internationally and in Singapore, the leading cause of death from cardiovascular~     disease. Cardiovascular magnetic resonance (CMR) has the ability to assess heart structures,~     scarring or lack of blood supply to the heart muscle with great accuracy and without any~     radiation involved. A CMR-compatible cycle ergometer can offer a safe and low cost stress~     equipment to assess heart function and motion abnormalities, and restrictions of the blood~     supply to the heart tissues due to partial or complete blockages of the blood vessels. This~     study aims (1) to develop an exercise-CMR stress protocol by testing its feasibility and~     robustness in assessing changes in cardiac volumes and function due to physical exertion in~     healthy individuals and (2) to assess the accuracy of the multiparametric stress-CMR as a~     diagnostic tool for ischemic-causing coronary artery disease (CAD) with coronary fractional~     flow reserve (FFR) as a reference.~   "
26721|NCT03217214|"~     In the proposed method of sensing the vital health sign related to CVDs, thermal heat~     transfer performance of the skin will be evaluated using a non-contact based IR temperature~     sensor. The temperature of the skin is significantly dependent upon the heat source as blood~     vessels (veins and capillaries) in the vicinity of the skin. However, there are several~     locations in the human body, where arteries are also at a relatively less depth from the~     outer skin surface (radial or ulnar arteries at the wrist and carotid artery in the neck). If~     it is possible to track the flow of blood from the thermal performance of the skin, then it~     could be useful in predicting various states of the human health related to cardiovascular~     activities.~      Subjects will undergo Existing Procedure EP- Passive Thermography PT for Phase I and Existing~     Procedure EP- Active Thermography ATLIC/ATPC for Phase II, with Duplex Ultrasound being the~     existing procedure that is considered as more reliable in clinical practice. Existing Passive~     Thermography will be used to setup the baseline data for Phase I. The currently~     under-development temperature mapping method (Active Thermography) that involves application~     of cooling (either pulsed or lock-in cooling) over the skin will be utilized for Phase II.~   "
26722|NCT03217201|"~     Cancer related fatigue (CRF) is a stressful and constant tiredness related to cancer and/or~     its treatment. CRF is the most intense during treatment and can severely interfere with~     activities of daily living, such as tasks that require physical strength or thinking clearly.~     Prevalence of CRF has been reported to be as high as 94% during chemotherapy and as high as~     34% five years after completion of treatment (Rotonda et al. 2013; Minton & Stone 2008).~     There is currently no generally-accepted treatment for CRF. However, there is evidence to~     suggest that light therapy can help with CRF. Non-pharmacological interventions for CRF have~     also been studied but are costly to implement and involve significant patient burden,~     particularly among those in active treatment. Given the clinical impact of CRF, the goal of~     this project is to investigate a novel, low-cost and low-burden intervention for Breast~     Cancer patients using a particular kind of light treatment called systematic light exposure~     (sLE) to treat CRF. Two hundred forty-eight breast cancer (BC) patients undergoing adjuvant~     or neoadjuvant chemotherapy will be recruited from Mount Sinai Medical Center and Memorial~     Sloan Kettering Cancer Center. The light will be administered by a small, personal Litebox~     daily throughout entire duration of chemotherapy. Outcomes will be assessed at eight~     timepoints during chemo, and a series of follow up assessments at 1 week, 1-month, 3-months~     and 6-months post-chemotherapy. This study will have major public health relevance as it will~     determine if an easy-to-deliver, inexpensive, and low patient burden intervention effectively~     reduces CRF or prevents it from worsening during chemotherapy. Specific Aims: Aim 1:~     Determine if sLE prevents CRF from worsening in BC patients undergoing chemotherapy Aim 2:~     Determine whether sLE affects sleep, depression and circadian activity rhythms. Exploratory~     Aim 3: Investigate sLE normalizes circadian cortisol rhythms. Exploratory Aim 4: Examine~     whether the effects of sLE on fatigue are moderated/mediated by sleep quality, depression,~     and/or circadian rhythms.~   "
26723|NCT03217188|"~     The purpose of this study is to evaluate the tumor control and the side effects of using~     proton therapy for head and neck cancer that has come back.~   "
26724|NCT03217175|"~     The study will consist of two study arms. Each arm will include a 24-96 hour outpatient~     run-in period prior to their exercise visit wearing the bi-hormonal bionic pancreas. In~     random order subjects will then complete two approximately 5-hour exercise visits, one~     wearing the bi-hormonal bionic pancreas and one wearing the insulin-only bionic pancreas.~   "
26725|NCT03217162|"~     Acute respiratory distress syndrome (ARDS) in neonates has been defined, the role of~     surfactant is not clear. This study aimed to determine whether ARDS neonate would benefit~     from surfactant when oxygenation deteriorated on mechanical ventilation and to identify any~     potential risk factors related to mortality.~   "
26726|NCT03217149|"~     Acute respiratory distress syndrome (ARDS) in neonates has been defined, the role of heliox~     is not clear.This study aimed to determine whether ARDS neonate would benefit from heliox~     when oxygenation deteriorated on mechanical ventilation and to identify any potential risk~     factors related to mortality.~   "
26727|NCT03217136|"~     This study aims to evaluate the safety and tolerability of MK-7625A (ceftolozane/tazobactam)~     plus metronidazole, compared with that of meropenem in pediatric participants with cIAI.~   "
26728|NCT03217123|"~     A prospective, randomized, double-blinded study was conducted in 7 OCD patients during which~     4 electrode contacts along a striatal axis were stimulated bilaterally. DBS electrode~     implantation followed a trajectory placing contact zero in nucleus accumbens (a common target~     for OCD treatment) with more proximal contacts placed in striatal segments defined using~     projections from prefrontal cortex subdivisions (ventromedial, orbitofrontal, dorsolateral)~     and anterior cingulate cortex.~   "
26730|NCT03217097|"~     Neuroendocrine tumors (NET) are rare but their incidence is growing. Alkylating agents (ALKY)~     are one of the main systemic treatments used, at least for advanced pancreatic NETs, with a~     response rate of 30 to 40% and a median progression-free survival of 4 to 18 months.~     Chemotherapy is one of the few therapeutic weapons, along with everolimus, somatostatin~     analogs, and metabolic radiotherapy, for pulmonary NETs, called typical and atypical~     carcinoids, even if the level of proof of efficacy for these treatments is lower than for~     pancreatic NETs. Considering the available retrospective data, O6-Methylguanine-DNA~     methyltransferase (MGMT) appears to be a predictive factor of the response to ALKY.~     Oxaliplatin (OX) has demonstrated an interesting activity, with response rates between 17%~     and 30%. In a first retrospective study we showed that Gemox is effective in NET, and more~     recently that its activity is similar to that of ALKYs, but without being influenced by the~     MGMT status. Prospective studies are needed but our data suggests that ALKY should be offered~     first to patients with methylated MGMT tumors while Oxaliplatin-based chemotherapy should be~     offered first to patients with unmethylated MGMT tumors. In this project, we wish to evaluate~     the contribution of the MGMT methylation, evaluated in the tumor, in predicting the Objective~     Response (OR) in patients treated with ALKY and to carry out the first randomized phase II~     study comparing a treatment with alkylating agents to Oxaliplatin in patients with a~     pancreatic or broncho-pulmonary NET.~      The main objective of this study is to evaluate the usefulness of tumor MGMT methylation in~     the prediction of the Objective Response (OR) at 3 months in patients treated with ALKY for a~     NET, assessed using the RECIST v1.1 criteria by centralized reading carried out by an expert~     radiologist blinded to the results of the MGMT methylation.~   "
26731|NCT03217084|"~     Dental caries is the destruction of the tooth structure in the presence of organic acids~     produced by cariogenic bacteria located in the dental biofilm (Dowker et al., 1999 and~     Robinson et al., 2000).Tooth enamel comprises 90% substituted hydroxyapatite (Ca10 (PO4)6(OH)~     2), which is subjected to consecutive cycles of demineralization and remineralization. This~     is an interrupted process, with periods of remineralization and demineralization occurring,~     depending on the state of the oral environment in terms of the prolonged accumulation and~     retention of bacterial plaque on the enamel surface (Aoba, 2004).~      Oral bacteria ferment carbohydrates to produce organic acids which lower the pH and cause the~     subsurface dissolution of the hydroxyapatite crystals. Under normal physiological conditions~     (pH7), saliva is supersaturated with calcium and phosphate ions which diffuse into the~     vacancies created during acid-mediated demineralization episodes (Dowker et al., 1999 and~     Robinson et al., 2000). The demineralization of enamel (white spot lesions) is a significant~     problem during and after orthodontic treatment with prevalence 71.1% and various preventive~     measures have been suggested to minimize the incidence (Derks et al., 2004 and Al Maaitah et~     al., 2011).~   "
26732|NCT03217071|"~     This is a randomized single-institution, phase II, open-label clinical trial of neoadjuvant~     pembrolizumab with or without low-dose stereotactic radiation therapy (SRT) in stage I-IIIA~     non-small lung cancer (NSCLC) patients who are planned to undergo surgical resection of their~     lung cancer.~   "
26733|NCT03217058|"~     Substance use disorders (SUDs) and depression in HIV-infected patients result in poor HIV~     outcomes, yet are often unrecognized and untreated. To address these problems, this study~     examines the implementation and effectiveness of a clinical intervention consisting of~     self-administered tablet-based SUD and depression screening at routine HIV primary care~     clinic visits, followed by evidence-based treatments for SUD and depression delivered by a~     behavioral health specialist. If successful, this study has potential to reduce SUD- and~     depression-related problems and reduce HIV treatment disparities for patients with these~     comorbidities.~   "
26734|NCT03217045|"~     Nutrition is a major issue for premature infants. Inappropriate nutritional intake during the~     first weeks of life is responsible for postnatal growth restriction and adverse long-term~     outcomes.~      This study aimed at evaluating the impact of the introduction of an updated, standardized,~     nutrition protocol on very premature infants' growth and morbidity, and the care givers'~     compliance to the new protocol.~   "
26735|NCT03217032|"~     This study is a Phase I/II trial using an advanced lentiviral vector to deliver a normal gene~     for human clotting factor VIII or factor IX into patients with hemophilia A or hemophilia B,~     to evaluate the safety and efficacy of IV infusion of gene modified autologous hematopoeitic~     stem cells and mesenchymal stem cells in patients.~   "
26736|NCT03217019|"~     In neonate and infant, radial artery cannulation may be challenging and multiple attempts are~     required because of the small diameter.~      The invastigators will compare the success rates of radial arterial cannulation with a~     guidewire-assisted technique and the direct technique in pediatric patient(<1yr).~   "
26737|NCT03217006|"~     The primary hypothesis of ROMA is that in patients undergoing primary isolated non-emergent~     coronary artery bypass surgery (CABG), the use of two or more arterial grafts compared to a~     single arterial graft is associated with a reduction in the composite outcome of death from~     any cause, any stroke, post discharge myocardial infarction and/or repeat revascularization.~     The secondary hypothesis is that in patients undergoing primary isolated non-emergent CABG,~     the use of two or more arterial grafts compared to a single arterial graft is associated with~     improved survival.~      Prospective event-driven unblinded randomized multicenter trial of at least 4,300 subjects~     enrolled in at least 25 international centers. Patients will be randomized to a single~     arterial graft (SAG) or multiple arterial grafts (MAG). Patients will be randomized in a 1:1~     fashion between the two groups. Permuted block randomization with random blocks stratified by~     the center and the type of second arterial graft will be used to provide treatment~     distribution in equal proportion.~   "
26738|NCT03216993|"~     compare different enteral nutrition strategy in patients with mechanical ventilation~   "
26739|NCT03216980|"~     Specific Aim #1: Examining the impact of posttraumatic stress disorder (PTSD) on peripheral~     vascular function and sympathetic nervous system activity in young individuals.~      Specific Aim #2: Examining the impact of posttraumatic stress disorder (PTSD) on peripheral~     hemodynamics and metabolic byproducts during small muscle mass exercise in young individuals.~      Specific Aim #3: Examining the impact of posttraumatic stress disorder (PTSD) on exercise~     tolerance, peripheral hemodynamics and metabolic byproducts during large muscle mass exercise~     in young individuals.~   "
26762|NCT03216681|"~     The purpose of this study is to evaluate the effectiveness of Hoat Huyet Nhat Nhat on the~     reduction of common symptoms related to the insufficient blood supply to the brain such as~     headache, vertigo, dizziness, sleep disorders and forgetfulness; compared with Gingko Biloba~     Egb761 (Tanakan) after 45 days of treatment~   "
26763|NCT03216668|"~     The purpose of this study is to evaluate the efficacy TONKA on the reduction of ALT and AST~     in moderate to severe liver enzyme elevated patients; compared with Silymarin (Legalon) after~     6 weeks of treatment.~   "
30319|NCT03170193|"~     A study to assess the safety and tolerability of AMG 529 following single, ascending doses~     administered subcutaneously (SC) or intravenously (IV) in healthy subjects~   "
26740|NCT03216967|"~     BK virus nephropathy (BKVN), a consequence of the strong immunosuppressive therapy given~     after kidney transplantation, represents a growing problem in the kidney transplant (KT)~     setting. In recent cohorts, BKVN concerns up to 10% of kidney transplant recipients and early~     signs of BK virus (BKV) infection as development of asymptomatic viruria and viremia are even~     much more frequent (40% and 20% of patients, respectively). In this context, finding~     strategies to prevent BKV infection or treat patients before the occurrence of BKV~     nephropathy is challenging. For several years, detection of BKV replication by real-time PCR~     in urine and/or blood of kidney transplant recipients at early stages of infection allowed~     adaptation of their therapy. As BKV reactivates essentially in patients with~     over-immunosuppression, the first step of the treatment is the reduction of~     immunosuppression. However, reducing immunosuppression (IS) can lead to acute rejection and~     allograft loss. Other treatments have been proposed (cidofovir, quinolones) but their~     toxicity profile or their lack of clinical efficacy are now demonstrated. Hence, an efficient~     and safe strategy against uncontrolled BKV replication is urgently needed. MTor-inhibitors~     are well known immunosuppressive drugs used in organ transplantation to prevent~     graft-rejection. They have furthermore anti-viral effects that can be beneficial for~     prevention of viral infections after transplantation. Recent evidence that inhibition of mTor~     pathway had an impact on BK infected cells provides additional insight into the observed~     benefits associated with these drugs. The aim of our study is to evaluate the effect of the~     mTor inhibitor everolimus on the prevention of severe BKV infection (BKV nephropathy or loss~     of the allograft) after kidney transplantation compared to the reduction of immunosuppression~     alone in kidney recipients with BK viremia.~   "
26741|NCT03216954|"~     This study will evaluate the behavioral effects of alcohol during placebo and~     n-acetylcysteine maintenance using sophisticated human laboratory methods.~   "
26742|NCT03216941|"~     comparison of intramuscular olanzapine and ketamine efficacy as first medication for fast~     sedation of patients with agitation and aggressive behavior. Five hundred patients with~     agitation caused by psychiatric disorder were randomly assigned under double-blind conditions~     to receive olanzapine or ketiapine. The Overt Agitation Severity Scale, Overt Aggression~     Scale and Ramsay Sedation Scale will be applied within 12 hours after the first dosage.~   "
26743|NCT03216928|"~     Blood test in Rheumatoid Arthritis (RA) patients with good response to anti-Tumor Necrosis~     Factor (anti-TNF) and in patients with moderate or non-response will be done in the month~     following the evaluation of clinical response to therapy. Isolation of mononuclear cells and~     purification of monocyte by negative selection. Cell culture of monocyte in presence or not~     of anti-TNF for 24 hours and analyze of CD36 (cluster of differentiation antigen 36)~     expression (principal outcome). For secondary outcomes analyze monocyte phenotype, NRF2~     nuclear translocation, and clinical data of patients.~   "
26744|NCT03216915|"~     The current study sought to prolong the observational interval after initiating medication~     with fingolimod and to measure the long-term effects of fingolimod on HR and HRV as an~     indicator of autonomic nervous system function in patients with RR-MS.~   "
26745|NCT03216902|"~     Treatment of elevated pressure in the eye (Intraocular pressure, or 'IOP') with eye drop~     medications has been shown to be effective in delaying or preventing the progression of~     glaucoma, and it is the only proven method for reducing the risk of glaucomatous visual field~     loss.~      This study is being conducted to determine how well DE-126 ophthalmic solution works~     (efficacy) in safely lowering IOP when dosed as topical eyedrops. This study will evaluate~     the safety and efficacy of four (4) concentrations of DE-126, when compared with latanoprost~     (0.005%) eye drops in patients with primary open-angle glaucoma or ocular hypertension.~      The IOP will be measured at 3 different times throughout the day, over 6 total visits during~     a 3-month treatment period (with up to 4 extra weeks observation if the patient must stop~     taking current eye drops to lower IOP). Safety assessments will be done throughout the study,~     including ocular signs and symptoms, vital signs, and clinical laboratory tests. While the~     most important time-point to measure IOP in this study and evaluate efficacy will be at the~     final study visit (month 3), IOP values will also be evaluated at other visits throughout the~     3-month treatment period.~   "
26746|NCT03216889|"~     The purpose of this study is to learn if cognitive behavioral therapy for insomnia (CBT-I)~     will improve sleep quality, fatigue, and quality of life in individuals with multiple~     sclerosis (MS) with symptoms of insomnia.~   "
26747|NCT03216876|"~     This is an open-label, active treatment trial to determine the pharmacokinetics of orally~     administered ursolic acid and to assess the potential efficacy and safety of ursolic acid in~     subjects with primary sclerosing cholangitis (PSC).~   "
26748|NCT03216863|"~     The feasibility and impact of respiratory rehabilitation (RR) in patients with advanced or~     metastatic (EGF-R WT or mutated) non-small cell lung cancer treated with oral targeted~     therapy including Inhibitors of EGF-R tyrosine kinases (TKI) and ALK inhibitors.~      These patients will benefit, at the beginning of the chemotherapy whatever the treatment~     line, of a respiratory rehabilitation. The respiratory rehabilitation takes place at the~     patient's home with the HAD's cooperation 3 hours per week, divided into 2 or 3 sessions.~     There is associated educational, nutritional and psychological support for a total duration~     of 8 weeks.~   "
26749|NCT03216850|"~     Characterisation of the lipidome and parenteral nutrition modulate the endothelial~     glycocalyx.~      The aim of the study A is to detect any influence of the lipid emulsion on the endothelial~     glycocalyx in patients in critical care. The targeted cohort is patients on ICU with an~     indication for parenteral nutrition including lipid emulsion. 15 patients are planned to be~     enrolled.~      Monitored variables: demographic data, type of the population, type of the lipid emulsion,~     selected variables of the lipid metabolism, sublingual microcirculation (SDF imaging),~   "
26750|NCT03216837|"~     Perinatal stroke causes lifelong neurological disability and most hemiparetic cerebral palsy~     (CP). With morbidity spanning diverse aspects of a child's life and lasting for decades,~     global impact is large, including 10000 Canadian children. With pathophysiology poorly~     understood and prevention strategies non-existent, the burden of hemiparetic CP will persist.~     Limited treatments lead to loss of hope for children and families, necessitating exploration~     of new therapies. The investigators have evidence that the investigators have a durable new~     treatment for perinatal stroke, combining non-invasive neurostimulation and child-centred~     intensive rehabilitation. Via the CHILD-BRIGHT SPOR national network, the investigators will~     execute a multicentre trial to prove this treatment can improve function in children with~     perinatal stroke and hemiparetic CP. Using novel advanced technologies not available~     elsewhere in the world, the investigators will explore how developmental plasticity~     determines function and response to neuromodulation therapy. This patient oriented effort~     will advance personalized, precision medicine in pediatric neurorehabilitation to improve~     outcomes for disabled children and their families.~   "
46484|NCT02958436|"~     The primary objective of this study is to evaluate the safety and tolerability of single~     ascending intravenous (IV) and subcutaneous (SC) doses of REGN3500 in healthy adult males and~     females~   "
26752|NCT03216811|"~     Nutraceuticals have attracted interest as possible approach to be associated with lifestyle~     changes for lowering plasma cholesterol levels in patients with moderate~     hypercholesterolemia. Ruscica and colleagues showed that a 8-weeks treatment with a~     nutraceutical combination containing red yeast rice extract, berberine, policosanol,~     astaxanthin, coenzyme Q10, and folic acid was able to reduce significantly total cholesterol~     (−12.8%) and low-density lipoprotein-cholesterol (−21.1%) [11]. These nutraceutical compounds~     exert their lipid-lowering effect through different ways, like the inhibition of the~     hydroxymethylglutaryl coenzyme A (CoA) enzyme, increasing the hepatic expression of low~     density lipoprotein (LDL) receptor and the LDL degradation via enhanced hepatic binding and~     internalization. In addition, they up regulate the numbers and function of circulating~     endothelial progenitor cells increasing nitric oxide (NO) production. The purpose of the~     present study was to assess the effectiveness of CARDIOVIS COLESTEROLO 3 mg (containing red~     rice fermented with Monascus purpureus titrated with 3% monacolin K, hydrol mixture of olive~     fruit titrated with vitamin E, Coenzyme Q10 and polymethoxyflavones) in terms of cholesterol,~     endothelial and inflammatory parameters reduction.~   "
26753|NCT03216798|"~     This study will investigate preferences for HIV care among participants enrolled in the~     Study to evaluate the feasibility of Community-based Test and Treat strategies among men who~     have sex with men and transgender women to increase the uptake of HIV testing and treatment~     services in Thailand through a model involving linked strategies: The study takes place in~     four provinces at six sites affiliated with the Thai Red Cross AIDS Research Center (TRCARC):~     Bangkok (RSAT and SWING), Chiang Mai (CAREMAT), Chonburi (SWING and Sisters) and Songkhla~     (RSAT). These are all community-based drop-in centers, targeting MSM and TGW.~      Participants who are enrolled in the study at any of the TRCARC affiliated sites and who were~     tested HIV-positive will be invited to participate in the current questionnaire study.~   "
26754|NCT03216785|"~     Prospective registry of patients admitted to the medical intensive care unit Patients~     discharged are followed up to 5 years after discharge~   "
26755|NCT03216772|"~     The study is designed to evaluate the safety of performing in-bag morcellation of uterus~     tissues during laparoscopic hysterectomy (LSH or TLH). Pre- and perimenopausal women, aged~     35-50 undergoing laparoscopic supracervical hysterectomy (LSH) or total laparoscopic~     hysterectomy (TLH)~   "
26756|NCT03216759|"~     To investigate the morbidity of intestinal injury after open surgery and observe the effect~     of comprehensive intestinal protection strategy on postoperative intestinal complications in~     patients undergoing laparotomy with general anesthesia.~   "
26757|NCT03216746|"~     Adolescence is a phase of important redefinitions and become an important period in the~     construction of new habits. Therefore, oral health education becomes strongly necessary,~     since good habits acquired at this stage may be perpetuated for adult life. The aim of this~     study is to evaluate the influence of an educational protocol on oral health in oral~     knowledge and clinical conditions in adolescence. A longitudinal study is being conducted~     with an initial sample of 291 adolescents enrolled in a public school in the city of~     Curitiba, Paraná, Brazil. The educational protocol was built in four phases. In phase I, the~     participants answered a questionnaire (pre-test) that included five statements about~     periodontal diseases and their forms of prevention. The answers were arranged in a Likert~     scale with a score of 1 (one) for the correct responses and 0 (zero) for the incorrect ones,~     obtaining, therefore, the knowledge score (KC). At this stage, adolescents is also being~     clinically assessed using simplified oral hygiene index (IHO-S) for dental plaque evaluation~     and gingival bleeding (ISG). In phase II, the sample (n = 291) is being randomly divided into~     two groups that receive two different educational interventions: oral orientation (OR) and~     video (VD). After each intervention, the questionnaire (post-test) is being reapplied. In the~     next phase (III), the study population (n = 291) is being again divided into four groups, and~     for two of them (OR + APP / VD + APP) a smartphone app was developed to messages which are~     being sending over a period of 30 days. In phase IV, the participants (n = 263) are answering~     again to the questionnaire (follow-up test) and are being reassessed clinically.~     Non-parametric tests and univariate and multivariate Poisson regression with robust variance~     will be used for statistical analysis (α = 0.05).~   "
26758|NCT03216733|"~     The aim of the Danish Organisation for randomised trials with clinical outcome (SORT OUT) is~     to compare the safety and efficacy of the ComboTM stent and Orsiro™ stent in the treatment of~     unselected patients with ischemic heart disease, using registry detection of clinically~     driven events.~   "
26759|NCT03216720|"~     Rationale:~      Contemporary coronary artery bypass grafting (CABG) continues to be associated with a~     significant risk of postoperative bleeding. Utilization of miniaturized extracorporeal~     circulation (miECC) significantly reduces the risk of postoperative bleeding but the~     underlying mechanisms are poorly understood.~      Primary Objective:~      To assess the impact of miECC compared to conventional extracorporeal circulation (cECC) on~     thrombin generation as indicator of the overall haemostatic capacity after CABG.~      Secondary Objectives To evaluate the impact of miECC versus cECC on blood loss and~     transfusion requirement, coagulation and fbrinolysis, inflammatory response, haemodilution~     and haemolysis, endorgan protection, seasibility and safety~      Study design:~      Single-center, double-blind, parallel-group randomized controlled trial~      Study population:~      60 Patients undergoing non-emergent primary isolated CABG with ECC randomized 1:1 to receive~     either miECC or cECC~   "
26760|NCT03216707|"~     Brain stimulation is a technique that can alter cortical function and thus be suitable for~     treating pain. This is especially when pain is chronic and associated with functional and~     even structural reorganization of the central nervous system. The idea of using invasive and~     noninvasive brain stimulation for pain relief is not new. Studies from the 1950s have~     investigated the brain stimulation for therapeutic use. Direct implantation of electrodes on~     the cerebral cortex has been carried out by Tsubokawa and colleagues in Japan. Although~     reported to be effective, it is invasive and involves the implantation of a foreign body into~     the cranium. Recent advancements in the techniques of non-invasive brain stimulation have~     improved and have measurable modulatory effects making this an attractive alternative for~     treating pain~   "
26761|NCT03216694|"~     A retrospective hospital-based cohort study of the association between preoperative~     cardiopulmonary exercise test (CPEX) variables and short-term postoperative morbidity~     following oesophagectomy.~   "
26764|NCT03216655|"~     Nowadays, doctors put mental health at a prior place and pay more attention to the~     psychological problems of ill kids' parents. In our research, we try to find a new modern and~     efficient psychological counseling mode to improve the mentality of parents and relieve their~     anxiety and depression. We divide guardians of parents into two groups .One group is given~     the traditional follow-up by regular phone call every month. The other is in a wechat group.~     A doctor send the useful information about kids care and answer questions of parents at~     regular time every month. The self-rating anxiety scale (SAS) and self-rating depression~     scale (SDS) scores of parents are marked before and after the long follow up.~   "
26765|NCT03216642|"~     An observational study was designed to research the bacteriology and pathogen drug~     sensitivity of chronic dacryocystitis in China and optimize antibiotic therapy.~   "
26766|NCT03216629|"~     Use of dressing is common place following surgery, allowing for wounds to be covered and~     protected. Dressing material with adhesive contact layers or adhesive tape is integral to~     sealing off the wound. Mechanical stripping of stratum corneum during dressing removal causes~     pain and discomfort. During dressing removal, practitioners may at times apologize as a~     function of empathy. Previous study investigated speed of dressing removal and its effect on~     discomfort during dressing change. In this study, the investigators aim to investigate how~     empathy expressed in form of saying sorry affect the perception of pain during dressing~     change?~   "
26767|NCT03216616|"~     Fatigue is common and debilitating in rheumatic inflammatory diseases as for other chronical~     medical conditions. The purpose of this study is to develope and evaluate a cognitive~     behavioural intervention targeting fatigue. The aim of the intervention is to improve fatigue~     self-management by changing behavioral and cognitive factors contributing to perceived~     fatigue. Levels of fatigue, depressive symptoms and self esteem will be measured before,~     after and three months after the intervention.~   "
26768|NCT03216603|"~     Health literacy refers to personal and relational factors affecting a person's ability to~     acquire, understand and use information about health and health services. In a need~     assessment study it was found that, the health services need to focus on health literacy~     factors in the follow up of patients with chronic obstructive pulmonary disease (COPD).~      Thus, this project evaluate the effect a of a health literacy partnership health promotion~     intervention (hospital, municipalities, university) after discharge from hospital with the~     use of motivational interviewing and tailored follow-ups on re-admission, health literacy,~     self-management quality of life and cost in people with COPD compared with usual care.~   "
26769|NCT03216590|"~     Strategies to minimize soft tissue swelling during shoulder arthroscopy are constantly sought~     after. The investigators propose an unfamiliar method which may reduce tissue swelling during~     shoulder arthroscopy.~   "
26770|NCT03216577|"~     Purpura fulminans (PF) is a rare life-threatening infectious disease characterized by the~     association of a sudden and extensive purpura together with acute circulatory failure. The~     mortality of PF has been reported to be as high as 50% in previous adult series.~     Additionally, patients surviving to the early phase of PF are exposed to a high risk of limb~     amputation. The hOPeFUL study aims at assessing the short and long term outcomes of adult~     patients admitted in the intensive care unit for a purpura fulminans.~   "
26771|NCT03216564|"~     Diabetic kidney disease (nephropathy) develops in nearly 40% of patients with type 2 diabetes~     mellitus. Diabetic nephropathy is caused by damage to the small blood vessels in the kidneys~     due to uncontrolled blood sugar levels, which mean that the kidneys become less effective at~     filtering urine. This is associated with albuminuria (protein in the urine). Treatment with~     some drugs reduces the loss of albumin through the urine and delays disease progression.~     There is increasing evidence that vitamin D could also be important in management of diabetic~     kidney disease. The aim of this study is to investigate the efficacy and safety of a combined~     regimen of calcitriol (active vitamin D) and established drugs for diabetic kidney disease.~   "
26772|NCT03216551|"~     Systemic mediastinal lymphadenectomy is deemed indispensable in lung cancer surgery for~     accurate staging and complete resection. However, extensive lymphadenectomy in patients~     without nodal metastasis may not improve survival and would increase operative duration and~     cause damage to mediastinal structures.Therefore the precise selection of patients without~     mediastinal nodal metastasis is the key to avoid unnecessary lymphadenectomy.The~     investigator's previous retrospective study shows tumor location and histological subtypes~     are exclusive predictors of negative mediastinal nodal disease. The current prospective~     observational study is to further verify the staging accuracy of this selective mediastinal~     lymphadenectomy strategy.~   "
26773|NCT03216538|"~     The purpose of this study is to evaluate the safety and efficacy of AS101 1% oral solution as~     compared to placebo in patients with neovascular Age-Related Macular Degeneration (AMD).~      AMD Patients who underwent 3 consecutive intravitreal anti VEGF injections and have sub~     retinal or intraretinal fluid at day 1 of study will be treated orally by AS101 1% solution~     or placebo once daily for 24 weeks and will be tested for sub retinal or intraretinal fluid~     every 4 weeks by OCT examination. In case of fluid in macula anti intravitreal anti VEGF~     injections will be given the same day as needed (PRN). Safety evaluation will be assessed by~     adverse events related to treatment of 1% AS101 oral solution or placebo. Efficacy will be~     evaluated in terms of duration of fluid free macula in the AS101 treated group as as compared~     to placebo treated group;~   "
26774|NCT03216525|"~     To determine if Alvimopan during open or robotic radical cystectomy with urinary diversion~     results in quicker return of bowel function (GI-2 recovery = time to upper [first toleration~     of solid food] and lower [first bowel movement] gastrointestinal recovery) compared to~     placebo.~   "
26775|NCT03216512|"~     The purpose of this study is to evaluate performance on the Attention Deficit Hyperactivity~     Disorder ( ADHD) Battery of the Cambridge Automated Neuropsychological Test Battery (CANTAB),~     including spatial working memory, inhibitory control, and attention while using either a~     noise cancelling headphone or sham headphone control in the presence of standardized auditory~     distractors in children and adolescents with ADHD.~   "
26776|NCT03216499|"~     This phase II trial studies how well HIF-2 alpha inhibitor PT2385 works in treating patients~     with recurrent glioblastoma. HIF-2 alpha inhibitor PT2385 may stop the growth of tumor cells~     by blocking some of the enzymes needed for cell growth.~   "
26781|NCT03216434|"~     This research study is being done to try to find a way to accurately diagnose post-traumatic~     stress syndrome (PTSD) in combat veterans.Diagnostic biomarkers have made invaluable~     contributions to the diagnosis and treatment monitoring of many diseases and disorders.~     Unfortunately, PTSD currently lacks a reliable and compelling clinically-relevant biomarker.~     The absence of a viable biomarker impairs efficient and confident diagnosis of PTSD, with~     diminished effective care options often resulting.~   "
26782|NCT03216421|"~     The goal of this study is to examine the role of Intraoperative Radiotherapy (IORT) in Ductal~     Carcinoma In-Situ (DCIS) and to improve the understanding of the clinical, radiographic, and~     patient-related impact of adopting IORT.~   "
26783|NCT03216408|"~     This clinical study evaluates the efficacy and safety of Neuronox compared with Botox in~     adults with moderate to severe glabellar lines.~   "
26784|NCT03216395|"~     In the management of patients with acute upper gastrointestinal bleeding from non-variceal~     causes, endoscopic treatment and acid suppression are now the standard of care. Current~     endoscopic treatment in the form of either thermo-coagulation or clipping to the bleeding~     arteries is highly efficacious in the stopping bleeding. Unfortunately in 5 to 10% of~     patients, bleeding cannot be controlled during index endoscopy or recurs after initial~     hemostasis. These patients are often elderly with significant co-morbidities. Their bleeding~     lesions are large eroding into major sub-serosal arteries. In the few who need surgical~     salvage, mortality increases to around 30%. The Over-the-scope-Clip (OTSC) is a device, which~     allows endoscopists to capture a large amount of tissue and compress on the bleeding artery.~     The OTSC also has a high retention rate. Recurrent bleeding with the use of standard~     hemo-clips can occur because of their low retention rate. We reported the use of OTSC with a~     high success rate in a case series of patients with refractory bleeding after standard~     endoscopic treatment. We have also used OTSC in the treatment of bleeding from~     pseudo-aneurysm arising from large eroded arteries in ulcer base. A multicenter randomized~     controlled trial that compares OTSC to standard endoscopic treatment in the endoscopic~     treatment of refractory bleeding lesions has just been completed. The use of OTSC has been~     shown to be superior in achieving hemostatic control and reducing further bleeding. In this~     proposed randomized controlled trial, we would test the hypothesis that the use of OTSC, when~     used as the first or primary treatment, is superior to standard treatment in achieving~     hemostasis and thereby improve patients' outcomes.~   "
26785|NCT03216382|"~     Excessive and uncontrollable worry has been associated with deficits in attention control.~     The Attention Training Technique (ATT; Wells, 1990) is a 12-minute audio recording that was~     developed to train attention control, so that individuals could learn to shift their~     attention away from maladaptive cognitive processes such as worry. The technique has shown to~     be promising at reducing symptoms across a variety of mental disorders (Knowles, Foden,~     El-Deredy, & Wells, 2016) and is recommended for use in people who suffer from chronic worry.~     To date, little research has been conducted examining the benefits of using this technique in~     such a population. The present study aims to examine the immediate and short term effects of~     weekly ATT practice, compared to a control condition, in a population that suffers from high~     levels of worry about a variety of topics. About one-hundred participants who suffer from~     chronic worry will be randomly assigned to listen to the ATT or a control recording, every~     day for a week. Changes in attention control, worry, and cognitive processes will be examined~     over the course of the intervention period.~   "
26786|NCT03216369|"~     Carotid artery stenting(CAS) and endarterectomy(CEA) are both important treatment strategy~     for patients with ICA (internal carotid artery) stenosis. Three dimensional pseudo-continuous~     arterial spin labeling (pCASL) is a noninvasive perfusion imaging modality to detect~     reperfusion for recanalization therapy. And it provides information about absolute CBF (ml~     100 g−1 tissue min−1) at the brain tissue level. The aim of the present study was to evaluate~     the series hemodynamic changes in patients who had conducted CAS or CEA by using 3D~     pseudo-continuous arterial spin labeling (pCASL) to explore the potential pattern of CBF~     alternation and thus to improve the prevention strategy for hyperperfusion syndrome.~   "
26787|NCT03216356|"~     This study aims to investigate the utility of d-cycloserine (DCS) for enhancing the effect of~     a novel psychosocial intervention, imagery rescripting (ImRs), in adult women with mild to~     moderate PTSD symptoms after experiencing sexual assault or interpersonal violence.~     Participants will receive 4 sessions of either cognitive behavioral therapy with imagery~     rescripting or cognitive behavioral therapy with imaginal exposure and will receive study~     medication (DCS or Pill placebo) prior to Session 2 and Session 3.~   "
26788|NCT03216343|"~     Chiauranib , which simultaneously targets against VEGFR/Aurora B/CSF-1R, several key kinases~     involved in tumor angiogenesis, tumor cell mitosis, and chronic inflammatory~     microenvironment.~   "
26789|NCT03216330|"~     Background: Endometriosis affects 10% of reproductive aged females, and can have a negative~     impact on sexual quality of life. Endometriosis can cause pelvic pain with deep penetration~     during intercourse, as well as other sexual and non-sexual pains. This study will allow us to~     determine if an increase in sexual pain is related to central sensitization.~      Purpose: The purpose of this study is to determine if there is an association between the~     severity of sexual pain and central sensitization in women with endometriosis.~      Measurement tools: Data will be collected from the Clinic's Data Registry, an online~     questionnaire, a quantitative sensory test (QST) to measure pain-pressure threshold (PPT) as~     a marker of central sensitization, and daily entry to an online survey.~      Primary Hypothesis: Central sensitization (measured by lower pain-pressure threshold) will be~     associated with an increased severity of deep dyspareunia, as well as a tenderness of the~     bladder/pelvic floor and depression, in women with endometriosis.~   "
26790|NCT03216317|"~     Objective: analyze the effects of isometric handgrip exercise on arterial pressure and on the~     autonomic cardiac modulation of hypertensive individuals treated in the Unified Health System~     (UHS).~      Intervention: Patients were randomized into Supervised group (SG) and control group (CG). SG~     will perform supervised isometric handgrip exercise for three weekly sessions in four sets~     with two minutes of isometric contraction with 30% of maximal voluntary contraction (MVC), In~     CG, individuals will be encouraged to increase their level of physical activity.~      Measurements: Blood pressure, autonomic modulation~   "
46630|NCT02956512|"~     Phase I Study to Evaluate the Safety of Dexibuprofen 300mg (Apsen Pharmaceuticals A / S.)~     After a Single and Multiple Dose Oral Administration in Healthy Participants of Both Sexes~     Under Fasting and Fed Conditions.~   "
26792|NCT03216291|"~     Biofeedback therapy is a labor-intensive, multi-disciplinary, team approach for the~     management of patients with Fecal Incontinence. It is not easily available to the vast~     majority of patients in the community with this problem. It is therefore imperative that a~     more pragmatic therapeutic approach that can be administered easily in the community ought to~     be developed. However, whether a treatment program that is based on home-training can be just~     as useful as office-based training has not been evaluated. The purpose of this study is to~     assess whether having patients train their pelvic floor muscles at home is as effective as~     in-office biofeedback training.~   "
26793|NCT03216278|"~     This is a bioequivalence study of two doses of the dapagliflozin/metformin XR tablet~     manufactured at two different plants.~   "
26794|NCT03216265|"~     The objective of this POC clinical study is to investigate the impact of the test product~     (Developmental Cosmetic Moisturising Cream) on skin barrier function and skin moisturisation~     on the forearm and face after 4 weeks of twice daily application compared to no treatment in~     participants with dry sensitive skin.~   "
26795|NCT03216252|"~     2622/5000 Mitochondrial diseases (MM) are the most common metabolic diseases. Since these~     pathologies are very heterogeneous in clinical terms, only the identification of mutations in~     nuclear genes or mitochondrial DNA confirms the diagnosis.~      The full-scale study of mtDNA by high-throughput sequencing (NGS) is a first step in the~     diagnostic approach. The recent introduction of this revolutionary new technology has greatly~     increased the efficiency of mutation identification. However, in addition to known pathogenic~     mutations, NGS reveals numerous variants whose significance is currently unknown. A major~     challenge to obtain a reliable diagnosis is therefore the interpretation of the clinical~     impact of these new rare variants which proves to be very difficult.~      Pathogenicity criteria allow the classification of variants from benign to pathogenic. One of~     the major pathogenicity criteria is a good correlation of heteroplasmic level with tissue or~     cellular involvement. Indeed, mtDNA mutations are generally heteroplasmic, which corresponds~     to the coexistence of normal and mutated molecules in the same cell or tissue, the most~     affected tissues having a high rate of mutation. On a muscle biopsy of an affected patient,~     the fibers often present an enzyme deficiency in cytochrome c oxidase (COX-negative) which~     can be demonstrated in immunohistochemistry. The single fiber study allows to isolate the~     deficient fibers and to quantify the heteroplasmic rate of a variant. The presence of a high~     level of heteroplasm in the COX-negative fibers, unlike fibers without deficit, is a strong~     argument in favor of the pathogenicity of this variant. Currently, this technique is not used~     routinely in diagnostic laboratories but only occasionally in a research framework in some~     laboratories. It is a heavy technique that consists of a first stage of laser microdissection~     of the various muscle fibers followed by a second step of quantification of the variant from~     each fiber. This second step requires a specific focus for each identified variant.~      The aim of this pilot study is to develop a new technique for quantification of single-fiber~     heteroplasmics isolated by NGS laser microdissection. This, independent of the type of~     variant, will avoid the long and costly adjustments required for each new variant identified~     and thus facilitate its use~   "
26796|NCT03216239|"~     After subtotal colectomy, 40% of patients report abdominal pain, gas and diarrhea, and poor~     quality of life; whose etiology is unknown. We determined whether small intestinal bacterial~     (SIBO or fungal overgrowth SIFO) could cause these sympotoms (> 1 year).~   "
26797|NCT03216226|"~     The trial's objective is to evaluate the immunogenicity of repeated single doses of~     dasiglucagon* and GlucaGen following subcutaneous (s.c.) administration in T1DM patients and~     further to evaluate the safety and tolerability of dasiglucagon and GlucaGen.~      *dasiglucagon is the proposed International Nonproprietary Name (pINN) for ZP4207~   "
26798|NCT03216213|"~     Two surveys are conducted. 1) a representative survey of the public's perception towards~     organ donation and 2) different messages to examine effect on family members'~     decision-making.~   "
26799|NCT03216200|"~     A study to determine if a three-treatment protocol with the RenewalNail™ plasma treatment~     system over a week will result in mycological cure and/or clear nail growth on the treated~     hallux toe.~   "
26800|NCT03216187|"~     This study will test the benefits and risks of using pregabalin perioperatively to prevent~     persistent postoperative pain in patients at high risk (>30%) of developing such pain after~     breast cancer surgery.~   "
26801|NCT03216174|"~     Laparoscopic sentinel lymph node dissection and stomach preserving surgery in early gastric~     cancer is less invasive method which can increase quality of life. Current stomach preserving~     surgery after sentinel lymph node dissection produce transmural communication and expose the~     tumor to the peritoneum during operation. An endoscopic full-thickness resection method with~     a simple suturing technique that does not expose the gastric mucosa to the peritoneum~     (non-exposure simple suturing, NESS) was recently developed.~      This is the pilot study to prove the feasibility of NESS-EFTR with sentinel node navigation~     in early gastric cancer patients.~   "
26802|NCT03216161|"~     This study was an update and amplification of exposure measurements of the EPIC-Potsdam~     Study, which started in 1994-1998.~   "
26803|NCT03216148|"~     FET PET 2010 is a prospective, multicentre trial aiming to evaluate the additional benefit of~     FET PET in the assessment of remission after first line therapy and during follow-up~   "
26804|NCT03216135|"~     This study will examine the hypothesis that altered esophageal microbiome leads to the~     development of esophageal adenocarcinoma (EAC). The aims of the project are, firstly the~     confirmation of relational data on the study cohort, using the methods developed and applied~     at the laboratory at University of Queensland Diamantina Institute (UQDI). Second, to~     generate a tissue microarray resource future tissue in-situ validation of microbes. And~     finally, to develop a biobank of clinical isolates of relevant esophageal microbes for future~     functional studies.~   "
26805|NCT03216122|"~     Previous studies have shown high success rates of immediately loaded implants on par with~     conventionally loaded implants (DL), while a few studies have also reported failure rates.~     Various studies can be found in the English literature comparing IL to DL protocol, few of~     which used the flapless approach while few used cylindrical implants or were confined to~     maxillary anterior region. Furthermore, a perusal of literature revealed no study which used~     RVG for radiographic evaluation and evaluated the morbidity at the implant site in normal~     healthy adult population. Hence this study would help determine whether the IL protocol is on~     par with DL protocol, so as to reduce patient waiting time, prevent space closure and provide~     early patient satisfaction from an aesthetic stand point.~   "
26806|NCT03216109|"~     The purpose of this study is to use a proactive approach to improve symptom management of~     patients with thoracic malignancies. In this pilot study, the investigators propose to~     evaluate the feasibility of using outbound, proactive telephone symptom assessment strategies~     and measure the efficacy of this approach on patient satisfaction with their care, patient~     activation, quality of life and use of healthcare resources.~   "
26807|NCT03216096|"~     The objective of this study is to assess safety and efficacy of DE-089 ophthalmic solution in~     patients with dry eye disease in Taiwan.~   "
26808|NCT03216083|"~     There are many risks for patients undergoing surgery, with blood loss and the risk of~     resulting anemia and blood transfusion being a common one. Decreasing blood loss with~     medication can be an important tool in reducing post-operative complications. Tranexamic acid~     (TXA) is an anti-fibrinolytic that inhibits the activation of plasminogen to plasmin. It~     inhibits the ability of plasminogen to dissolve fibrin networks, thus decreasing bleeding.~     TXA was shown in a systematic review and meta-analysis by Ker et. al in 2013 to reduce~     surgical blood loss by an average of 34% with an increased percentage reduction as the amount~     of bleeding during surgery decreased. This review also showed that a dose of 1g intravenous~     (IV) was sufficient in most adults with no evidence supporting a higher dose.~      Vaginectomy or total colpocleisis is a surgical procedure performed for women experiencing~     symptomatic pelvic organ prolapse. It is performed in women who have significant vaginal~     vault prolapse post-hysterectomy and wish an effective treatment but accept the inability of~     having penetrative vaginal intercourse. It is most often performed in older patients who have~     multiple co-morbidities that would preclude them from having a more invasive procedure to~     correct their prolapse, such as an abdominal sacral colpopexy which involves the placement of~     surgical mesh, is a significantly longer procedure, and has more associated surgical risks.~      This study will be a double-blind, placebo-controlled, randomized trial looking at whether 1g~     IV tranexamic acid compared with placebo reduces blood loss in women undergoing vaginectomy.~   "
26809|NCT03216070|"~     Our goal is to demonstrate that 50mg of dasatinib is as effective as the full dose to induce~     molecular response as first line therapy in CML.~   "
26810|NCT03216057|"~     The primary objetive was to evaluate the safety and efficacy the 3 grams per day of omega-3~     in adolescents with obesity and hypertriglyceridemia ( ≥ 150 mg/dl and ≤ 1000 mg/dl) for 12~     weeks, compared with placebo. Half of subjects received 3 grams of omega 3, while the other~     half received placebo.~   "
26811|NCT03216044|"~     There is no doubt, that surgery is very often the beginning of a chronic pain disorder.~     C-section is a worldwide performed operation with increasing trend in the developed countries~     .This prospective cohort study evaluated the incidence of persistent pain after childbirth in~     respect of the pain status before childbirth and the modus of delivery.~   "
26812|NCT03216031|"~     Wandsworth Integrated Falls and Bone Health Service (IF & BHS) provides an evidence-based~     falls prevention exercise programme, but yearly about 500 of 1800 patients decline~     participation or do not continue to exercise. Our study seeks to address this efficiency gap~     by developing a gardening programme as an alternative to traditional exercise. In a~     preparation period (4/17-5/17) we will explore the special needs of the target population~     through interviews and create an age appropriate gardening site at Growhampton, a gardening~     project run by the University of Roehampton; from 5/17 to 9/17 a falls prevention gardening~     group will be implemented and evaluated.~   "
26813|NCT03216018|"~     The study is a group randomized controlled trial. High school classes were allocated by~     randomization to the intervention or control group by a Randomization function in Excel~     computer program. Outcomes were measured by questionnaire at pre-intervention,~     post-intervention and 3-months follow-up. The study protocol was approved by Tel Hai College~     institutional review board. Parents of all participants, in the intervention and in the~     control group, received information about the program and the study and were asked to provide~     informed consent.~   "
26814|NCT03216005|"~     To evaluate the safety and effectiveness of the BlueLeaf System for the restoration of venous~     competence for the treatment of symptomatic chronic venous insufficiency (CVI).~   "
26815|NCT03215992|"~     This study is looking to see if a new device, diffuse optical tomography (DOT), can detect~     prostate cancer. The investigators will also see if DOT can tell the difference between high~     risk and low risk prostate cancers.~   "
26816|NCT03215979|"~     In this study investigators are trying to determine the benefits of using platelet enriched~     plasma during the second stage of auricular reconstruction. The intervention will be blinded~     to the surgeon and the surgical team. The main outcome will be the evaluation of the~     integration rate of the skin full thickness graft used to coat the auricular frame.~   "
26817|NCT03215966|"~     The primary objective of this study is to demonstrate that macitentan and tadalafil~     administered as a fixed combination is bioequivalent to both compounds given as separate~     tablets given at the same doses as in the fixed combination (i.e. whether the amounts of~     macitentan and tadalfil which reach the blood are comparable).~   "
26818|NCT03215953|"~     Offloading is the concept of relieving pressure to help prevent/cure plantar ulcers,~     especially in diabetic patients. Many forms of offloading are available, with many~     limitations to apply in clinical practice. In this study, the investigators compare cast shoe~     with forefoot offloading shoe considering effectiveness, complications, compliance and~     patient's appreciation.~   "
26819|NCT03215940|"~     This is a study comparing the effects of Delta-9-Tetrahydrocannabinol (THC) versus~     Cannabidiol (CBD) versus a placebo on chronic non-cancer pain.~   "
26820|NCT03215927|"~     A randomized, controlled pilot trial to evaluate the efficacy and safety of subcutaneous~     Abatacept in treating interstitial lung disease associated with the anti-synthetase syndrome.~   "
26821|NCT03215914|"~     Can a type 1 diabetic adult avoid low glucoses and regain hypoglycemia awareness using a~     hybrid closed loop insulin delivery system? Involvement is 22 months (13 visits) and includes~     a 4-week Screening Phase and an 18-month Intervention Phase. Participants will undergo 3~     Hyperinsulinemic Clamps done at: Baseline (before starting the device and after completing~     the screening), 6 months (after using the device 6 months), and after using the device for 18~     months. This metabolic testing will allow us to measure improvement in hypoglycemia~     awareness.~   "
26822|NCT03215901|"~     The mass provision of HIV treatment in rural KwaZulu-Natal, South Africa has raised adult~     life expectancy by 18 years since 2003. We will conduct a population-based survey to assess~     young adults' beliefs about HIV, HIV treatment, and expectations for the future in the era of~     mass HIV treatment. Thh investigators will conduct a randomized evaluation to assess whether~     a short video providing young adults with information on longevity gains from HIV treatment~     affects young adults survival expectations, hope for the future, and health and educational~     behaviours, including uptake of HIV testing and treatment services, the study's primary~     outcome.~   "
26823|NCT03215888|"~     Obesity is associated with alterations in brain structure and cognitive impairment and is a~     risk factor for Alzheimer's disease and vascular dementia. The mechanisms underlying obesity~     related decline in cognitive function are not fully understood. The long-term goal of this~     project is to understand how obesity affects cognitive function, with the aim to develop new~     ways to prevent and treat obesity related cognitive decline~   "
26824|NCT03215875|"~     This study will evaluate the effects of a high-fat meal (food effect) on the bioavailability~     and pharmacokinetics of 60mg ER Torsemide tablet after single dose oral administration in~     healthy volunteers. The study will be conducted as a two-sequence to period crossover study~     to compare 60mg ER Torsemide ER bioavailability under fed and fasting conditions. 60mg ER~     torsemide is a new strength and dosage form.~   "
26825|NCT03215862|"~     This is a randomized, double-blinded, controlled trial. This study is a head to head~     comparison of normal saline (NS) infusion versus Lactated Ringer's (LR) infusion in patients,~     with the primary outcome of post-ERCP pancreatitis occurrence. Patients will be randomized to~     either the NS infusion group or the LR infusion group. IVF will be started pre-procedurally~     and will be continued throughout the procedure. A IVF bolus will be given at the end of the~     procedure and then continued as a continuous infusion. Our null hypothesis is that there will~     be no significant difference in the rate of occurrence of post-ERCP pancreatitis between the~     infusion of LR and NS solutions. Our alternative hypothesis is that patients receiving LR~     solution infusion will experience a decreased rate of post-ERCP pancreatitis compared to~     patients receiving NS solution infusion.~   "
26826|NCT03215849|"~     A random-order cross-over pilot trial of a CE marked device (pacemaker) outside its current~     intended purposes.~      The study will comprise 10 patients. Recruitment of patients will take place from The~     University Hospital of Wales (Cardiff & Vale University Health Board [CVUHB]). All patients~     recruited will have septal flattening during exercise demonstrated using contrast stress~     (exercise) echocardiography.~      All 10 patients will be implanted with a CRT-pacemaker device and will be tested on all three~     of the following settings on separate visits (with a gap of up to 5 days between visits) in~     random order:~      Routine Medical Therapy Routine Medical Therapy + LVP Routine Medical Therapy + BiVP~   "
26827|NCT03215836|"~     The objective of this pilot study is to determine whether obesity and metabolic syndrome are~     in fact synergistic in relation to airway nitric oxide (NO) biology. To do so, the~     investigators want to determine how obesity and the metabolic syndrome relate to metabolism~     in bronchial airway epithelial cells and the nasal epithelium.~   "
26828|NCT03215823|"~     The usefulness of videolaryngoscope has been verified by several studies, and the frequency~     of videolaryngoscopy is increasing in clinical practice. Data on the use of~     videolaryngoscopes, however, were not sufficiently accumulated when compared with data on the~     use of previously used macintosh laryngoscopes. In addition, videolaryngoscopy increases the~     success rate of endotracheal intubation compared to conventional macintosh laryngoscopy, but~     endotracheal intubation with videolaryngoscope is not successful in all cases with one~     intubation attempt. Therefore, if the difficult endotracheal intubation with the~     videolaryngoscope can be predicted in advance, it may be possible to improve the success rate~     of intubation by reducing unnecessary use of the videolaryngoscope and preparing other~     equipment. There are many studies on the preoperative examination that can predict the~     difficulty of intubation when using a macintosh laryngoscope. However, there are still~     attempts to find screening tests that predict precisely the difficult endotracheal intubation~     because the accuracy of screening tests is not high. In particular, there is a lack of~     research on factors that can predict difficult endotracheal intubation when using~     videolaryngoscope. Therefore, the investigators aimed to investigate the factors predictive~     of difficult endotracheal intubation when attempting intubation using videolaryngoscope.~   "
26829|NCT03215810|"~     Investigators plan to study the safety, side effects, and benefits of tumor-infiltrating~     lymphocytes (TILs) when they are given with the drug nivolumab. Nivolumab is a type of~     immunotherapy - a drug that is used to boost the ability of the immune system to fight~     cancer, infection, and other diseases.~   "
26830|NCT03215797|"~     A prospective, double-blinded study. The present study consisted in applying Stroke volume~     variation fluid guided therapy to old patients (65 years old) undergoing radical resection of~     colon surgery. The aim of this study is to compare the effects of norepinephrine and~     phenylephrine in treating perioperative hypotension, and to find the safest and most~     effective vasopressor for elderly.~   "
26831|NCT03215784|"~     Obesity is one of the most concerning health issues in the modern world, especially due to~     its association with greater risk of developing a wide range of chronic diseases.~     Pre-gestational obesity may increase the chances of maternal and fetal morbimortality, such~     as gestational diabetes mellitus, preeclampsia, macrosomia and, even, fetal death. It may~     also lead to long term disorders, enhancing the risk of excessive adiposity and metabolic~     syndrome in later life and, thus, contributing to the maintenance of the obesity cycle and~     its health effects through the subsequent generations. Alterations in placental function are~     thought to be deeply involved in this scenario, however further research on its molecular and~     biological mechanisms is needed. During pregnancy, there is a physiological enhancement of~     the inflammatory state, marked by higher circulating cytokines and macrophage placental~     infiltration, which favors fetal nutrient supply and adequate growth; however, this response~     is exacerbated in women with pre-pregnancy obesity, leading to adverse outcomes. In this~     context, interventions aiming to reduce excessive inflammation may prevent or minimize the~     negative impact of pre-pregnancy obesity on both maternal and offspring's health. There is~     strong evidence suggesting an important role of n-3 LC-PUFA (EPA and DHA) on the attenuation~     and resolution of inflammatory states, besides influencing maternal lipid profile, fetal and~     infant adipogenesis and neurodevelopment. Additionally, the consumption of probiotic~     supplements during gestation seams to promote adequate maternal weight gain and improve the~     profile of inflammatory molecules secreted in the milk. Therefore, the nutritional~     interventions with fish oil, as a source of EPA and DHA, or probiotics, in women with~     pre-pregnancy obesity, may change the intrauterine environment and reduce the risk of both~     short and long term metabolic disorders. This study aims to investigate the metabolic and~     molecular changes promoted by gestational obesity and evaluate the effectiveness of different~     dietary interventions (fish oil or probiotic) on preventing or minimizing such alterations.~     We expect to contribute to the understanding of the physiological and molecular mechanisms~     underlying maternal obesity and its association with adverse pregnancy outcomes, associated~     with increased risk of chronic diseases in adulthood.~   "
26854|NCT03215472|"~     This study will test whether a digital health intervention (DASH Cloud) using smartphones can~     improve diet quality among women at risk for cardiovascular disease. The DASH (Dietary~     Approaches to Stop Hypertension) Diet has been proven to lower blood pressure, yet~     dissemination efforts remain poor. This study aims to use technology to improve adherence to~     DASH.~   "
28204|NCT03197818|"~     The purpose of this study is to demonstrate the superiority of CHF 5993 pMDI (fixed~     combination of extrafine beclometasone dipropionate plus formoterol fumarate plus~     glycopyrronium bromide) over Symbicort® Turbuhaler® in terms of pulmonary function, as well~     as to assess its safety.~   "
26832|NCT03215771|"~     The objective of this study is to document longitudinal outcomes in persons with traumatic~     brain injury (TBI) using the myoelectric upper limb orthosis with powered elbow and grasp~     using both patient centric performance and patient reported outcome measures. Longitudinal~     observation will allow the investigators to detect both the initial therapeutic effects as~     well as the later functional outcomes of orthosis use. The investigators plan to recruit 15~     Veterans and non-veterans who have TBI and upper limb impairment. The study requires 29~     visits over 22 weeks and is divided into four parts: enrollment, orthotic fitting,~     therapy/training (9 weeks), and home use (9 weeks). Therapeutic and functional benefits will~     be evaluated every 2 to 3 weeks over 18 weeks using simple, short clinical tests.~   "
26833|NCT03215758|"~     A randomized, multicenter, double-blind, placebo- controlled parallel-group study to~     determine the efficacy and safety of QAW039, compared with placebo, when added to~     standard-of-care (SoC) asthma therapy in adult and adolescent (≥ 12 years) patients with~     uncontrolled asthma with respect to change from baseline in forced expiratory volume in 1~     second (FEV1) at the end of 12 weeks of treatment.~   "
26834|NCT03215745|"~     To determine the efficacy of program of prevention of delirium in critically ill patients~     from the intensive care units of Bucaramanga and Floridablanca. Methods: The study will be a~     randomized controlled clinical trial in 600 critically ill patients recruited at 24 hours~     from arrival on the intensive care units of Bucaramanga and Floridablanca, without delirium,~     with ≥50% in the PREDELIRIC scale score, who comply with the inclusion and exclusion. The~     patients will be randomized in blocks to one of the two groups, intervention group (delirium~     prevention program, n=200) with control group (usual care; n= 400), the study will compare~     the incidence of delirium in both groups. Patients will be followed every day with Confusion~     Assessment Method for the Intensive Care Unit (CAM-ICU) until the patient presents delirium,~     exit to hospitalization or death. Delirium prevention program includes individualized~     nonpharmacological interventions such as multisensory stimulation, cognitive stimulation,~     activate the functional and family involvement. The study has received ethical approval from~     the University of Santander~   "
26835|NCT03215732|"~     This study aims at estimating the prevalence of chronic hepatitis B virus (HBV) infection in~     rural Senegal (area of Niakhar) and at evaluating the associated burden in terms of both~     health-related and socio-economic consequences.~   "
26836|NCT03215719|"~     This will be a phase II single-arm clinical trial. The purpose of this study is to determine~     the feasibility of deescalating chemoradiation treatment based onmid-treatment tumor~     response. The primary objective of this study is to evaluate progression-free survival at 2~     years.~   "
26837|NCT03215706|"~     The purpose of this study is to determine whether Nivolumab, Ipilimumab combined with~     chemotherapy is more effective than chemotherapy by itself when treating stage IV NSCLC as~     the first treatment given for the disease~   "
26838|NCT03215693|"~     The main purpose of the study is to evaluate safety and efficacy of X-396(Ensartinib) capsule~     in patients with ALK-positive non-small cell lung cancer previously treated with~     crizotinib.While exploring the relationship between biomarkers and drug efficacy and safety.~   "
26839|NCT03215680|"~     Urinary iodine concentration (UIC) is the recommended biomarker of iodine status in~     populations. Yet, the influence of climate on UIC remains unclear. Hot climate may reduce~     urine volume and consequently increase UIC independent of iodine status. This could lead to~     an overestimation of population iodine intake, thus masking iodine deficiency in vulnerable~     groups.~      In this longitudinal observational cohort study in women of reproductive age we will collect~     24h and spot urine samples in the summer and winter season. The influence of high temperature~     climates on UIC, measured and estimated urinary iodine excretion will be estimated.~   "
26840|NCT03215667|"~     Purpose of the single arm study is to clinically and histologically evaluate alloplastic~     in-situ hardening, moldable beta-tricalcium phosphate(TCP) bone graft material and~     polylactide membrane in alveolar ridge preservation following extraction of non-molar teeth~     with non-containable extraction sockets.~   "
26841|NCT03215654|"~     Objective: To evaluate the efficacy of 3 sensitivity and mental health literacy programs for~     young students in the increase of mental health knowledge, to help seeking and reducing the~     stigma in order to prevent mental disorders and to reduce symptoms.~      Design: Multicenter randomized clinical trial school-based during 12 months follow up.~     Setting: Educational centers of secondary education (E.S.O) (public or private) of Barcelona.~     Subjects: 408 students between 13 and 18 years old who attend 3rt ESO in 8 randomized schools~     of Barcelona.~      Interventions: 3 intervention groups of ascending intensity: 1) Sensitivity Program Mental~     Health (SP)(1h); 2) Mental Health Literacy Program (MHLP) (6h); 3) MHLP more Stigma Reduction~     (ER) ( MHLP+RE)(7h).Control group: waiting List.~      Measures of results:1) Mental Health Literacy; 2) Stigma associated with mental health; 3)~     Mental Symptoms and Positive Mental Health (SDQ); 4) Bullying and Ciberbullying; 5) Quality~     of life (E-5D); 6) Intent to change; 7) Help Seeking (AHSQ); 8) Use of Health Services and~     Treatment and 9) Satisfaction.~   "
26842|NCT03215641|"~     This study evaluates the role of personal activity trackers to help improve weight loss or~     weight maintenance for children and their parents enrolled in a comprehensive weight loss~     program.~   "
26843|NCT03215628|"~     Transcranial contrast-enhanced ultrasound for evaluation of cerebral blood flow during~     pediatric cardiac surgery. This study is aimed as a feasibility study prior to conducting a~     lager prospective clinical trial including neurologic and developmental outcome measures.~   "
26855|NCT03215459|"~     Cardiopulmonary exercise testing (CPET) has been shown to be superior to American Society of~     Anaesthetist classification (ASA) in predicting peri-operative risk. The most common~     performance status used is the World Health Organisation (WHO) (0-4), with a clinician agreed~     differentiation of the subsets of 0-2 and 3-4; variability also exists within these subsets.~      With this there rises a concern that fit older patients may not be offered appropriate~     chemotherapy treatment. This observational study will assess whether cardiopulmonary exercise~     testing (CPET) offers additional benefit over that of WHO Performance status (PS) in the~     assessment of patients fitness for palliative chemotherapy for pancreatic cancer, by~     identifying those patients who might survive longer and tolerate chemotherapy better, thus~     predicting their outcome.~   "
47427|NCT02946112|"~     The aim of this study is to assess the relationship between shoulder position and the~     presence of pain in volleyball players. To do this, will be measured pain sensation and the~     position of acromion process~   "
26844|NCT03215615|"~     Non-carious cervical lesion is frequently associated with gingival recession, resulting in a~     combined lesion that has a different treatment prognosis when the two lesions appear alone.~     The literature presents few studies that propose a multidisciplinary approach (restorative~     and root coverage surgery procedures) to optimize the treatment of this combined lesion. The~     previously proposed approaches and materials have limitations and an optimal clinical~     protocol has not been established yet. Thus the aim of this study is to evaluate a novel~     multidisciplinary protocol with two resin composites and two different adhesive systems~     through a randomized clinical trial and laboratory studies. 120 combined lesions will be~     randomly assigned to one of the following groups: NP + TE (n = 30) - Partial restoration of~     cervical lesions with nanofilled composite and total-etch adhesive system and periodontal~     surgery for root coverage, NP + UA (n = 30) - partial restoration of cervical lesions with~     nanofilled composite and self-etching adhesive system and periodontal surgery for root~     coverage, MH + TE (n = 30) - partial restoration of cervical lesions with microhybrid~     composite and total-etch adhesive system and periodontal surgery for root coverage, MH + UA~     (n = 30) - partial restoration of cervical lesions with microhybrid composite and~     self-etching adhesive system and periodontal surgery for root coverage. Restorations will be~     assessed using the USPHS criteria after one week, six months and twelve months.~   "
26845|NCT03215602|"~     Osteoarthritis (OA) of the knee is a chronic musculoskeletal disease, and a major cause of~     pain and disability worldwide. Exercise has previously demonstrated good effect in~     alleviating OA symptoms. However, optimal exercise modes in OA are currently unknown.~      This study seeks to evaluate the effects of supplementary focused, knee extensor strength~     training in addition to neuromuscular exercise (NEMEX) and education in people with OA of the~     knee as performed in Good Life with osteoArthritis in Denmark (GLA:D ᵀᴹ).~      Through a randomized design, study participants will either be allocated to 12 weeks (twice~     weekly) of NEMEX and education or 12 weeks (twice weekly) of NEMEX and education and focused,~     knee extensor strength training.~      The primary outcome measurement for this study is the Knee injury and Osteoarthritis Outcome~     Score, subscale Activities of Daily Living (KOOS-ADL), which is a self-reported questionnaire~     on daily life activities. Other outcomes include parameters of maximal muscle strength and~     muscle power, muscle imaging, physical function, pain and self-reported health status.~   "
26846|NCT03215589|"~     Cerebral oxygen desaturation during cardiac surgery measured using near infrared spectroscopy~     (NIRS) derived cerebral oximetry has been associated with significant postoperative~     morbidity. If significant desaturation occurs during this period, it may represent an ideal~     opportunity to further optimize the postoperative care of these patients.~   "
26847|NCT03215563|"~     Ischaemic stroke is a major cause of death and disability worldwide. In patients with recent~     stroke, the 18F-fluoride positron emission tomography-computed tomography highlights~     high-risk culprit carotid plaque and is more discriminatory than 18F-fluorodeoxyglucose.~     Using hybrid positron emission tomography-magnetic resonance imaging investigators propose to~     build upon these findings by prospectively assessing 18F-fluoride uptake in a broad range of~     patients with acute transient ischaemic attack or ischaemic stroke. Investigators will~     specifically examine the association of 18F-fluoride uptake with multiparametric magnetic~     resonance imaging assessments of atherosclerotic plaque, especially the role of thrombus and~     lipid. Finally, using transcranial Doppler and diffusion-weighted magnetic resonance brain~     imaging, an assessment of the functional consequences of 18F-fluoride-positive~     atherosclerotic plaque will be performed. If successful, this technique has a number of~     valuable translational applications including the better selection of patients for carotid~     intervention.~   "
26848|NCT03215550|"~     Ischaemic stroke is a major cause of death and disability worldwide. In patients with recent~     stroke, the 18F-fluoride positron emission tomography-computed tomography highlights~     high-risk culprit carotid plaque and is more discriminatory than 18F-fluorodeoxyglucose.~     Using hybrid positron emission tomography-magnetic resonance imaging investigators propose to~     build upon these findings by prospectively assessing 18F-fluoride uptake in a broad range of~     patients with acute transient ischaemic attack or ischaemic stroke. Investigators will~     specifically examine the association of 18F-fluoride uptake with multiparametric magnetic~     resonance imaging assessments of atherosclerotic plaque, especially the role of thrombus and~     lipid. Finally, using transcranial Doppler and diffusion-weighted magnetic resonance brain~     imaging, an assessment of the functional consequences of 18F-fluoride-positive~     atherosclerotic plaque will be performed. If successful, this technique has a number of~     valuable translational applications including the better selection of patients for carotid~     intervention.~   "
26849|NCT03215537|"~     This study aims to propose a perioperative comprehensive intervention based on health~     behavior model to improve cardiopulmonary function and quality of life among lung cancer~     patients following~   "
26850|NCT03215524|"~     This is a randomized phase II open label study of daratumumab, weekly low-dose oral~     cyclophosphamide and dexamethasone with or without pomalidomide in patients with relapsed and~     refractory multiple myeloma. The study consists of two arms. Patients will be randomized into~     ARM A and ARM B in a 1:1 ratio.~   "
26851|NCT03215511|"~     This is a Phase 1/2, multi-center, open-label study designed to evaluate the safety and~     efficacy of LOXO-195 when administered orally to patients age ≥ 1 month and older with NTRK~     fusion cancers treated with a prior TRK inhibitor.~   "
26852|NCT03215498|"~     The aim of the study is to compare the pharmacokinetics (i.e. the course of the blood~     concentrations of the administered trial drug) of faster-acting insulin aspart (faster~     aspart), and the currently marketed formulation of insulin aspart (NovoRapid®) when given as~     a bolus using an insulin pump in people with type 1 diabetes. The pharmacodynamic response~     (i.e. the course of the blood sugar lowering effect of the administered trial drug) and the~     safety and tolerability of faster aspart and NovoRapid® will also be assessed.~      The participants will be in the study for approx. 21 days. Each participant will have 5~     visits to the clinic, with an overnight stay at both dosing visits. Participants will have a~     number of tests, and they will have to give blood and urine samples.~   "
26853|NCT03215485|"~     Intervention targets youth ages 14 - 19 participating in soccer teams. The intervention group~     will be given face to face nutrition lessons and have access to an online immersive learning~     environment. The comparison group will not. The project will test if the immersive learning~     environment is effective in preventing unhealthy weight gain.~   "
26856|NCT03215446|"~     Halogenated anaesthetic agents (HAA) may induce protective processes by pre-conditioning the~     myocardium. All of the literature shows that HAA induce pre-conditioning, thanks to a class~     effect, and Sevoflurane is the most widely used today.~      In humans, the protective effects of halogenated agents have principally been studied in~     heart surgery and have shown encouraging clinical results. It seems that HAA induce both~     pre-conditioning of the myocardium (early and late) and post conditioning.~      Given these protective effects of HAA, in 2007, the American Heart Association (AHA)~     recommended the use of HAA for anaesthesia maintenance in non-cardiac surgery in patients~     with a high cardio-vascular risk. The aim of this study is to show a decrease in~     rhabdomyolysis and tissue distress (kidneys, myocardium and liver), thanks to Sevoflurane~     anaesthesia, in the post-operative period following vascular surgery with clamping~   "
26857|NCT03215433|"~     Biotine is proposed by neurologists to patients with a progressive form of Multiple sclerosis~     (MS) in the context of a nominative temporary authorization for use (TAU) as a~     disease-modifying treatment for their MS. A recent study showed that with this treatment,~     more patients experienced an improvement after one year in comparison with patients given a~     placebo.~      The objective of this study is to identify blood biomarkers to determine good responders as~     early as possible. In addition, the blood parameters studied will make it possible to better~     understand the mechanisms of action, that have a beneficial effect on multiple sclerosis.~      The management of patients will not be modified: same number of consultations (at the~     prescription, at 3 months, at 12 months), same clinical examination, and the same number of~     blood samples (at the prescription, at 3 months, and at 12 months).~   "
26858|NCT03215420|"~     The aim of this study is to compare 3 methods for the diagnosis of endolymphatic hydrops (EH)~     in patients with Meniere's disease: MRI 3 Tesla (to visualise EH directly), and functional~     explorations, namely electrocochleography and dephasing of acoustic distortion products~     (which are modified by the EH).~      The research hypothesis is that the examinations will show agreement in the diagnosis of EH,~     and that the results obtained (quantitative values) will vary in the same direction over time~     and during flares of MD.~   "
26859|NCT03215407|"~     Aim: Comparing the efficacy and safety of intra-articular injection of tocilizumab and~     compound betamethasone.~      Study design: A randomized, single-blind, parallel controlled and one center trial design.~      Sample size: 60 cases. Study content: Patients who meet inclusive criteria will be randomly~     divided into tocilizumab group and compound betamethasone group. In the baseline period, the~     investigators will collect patients' general information, disease information, disease~     activity score, laboratory results and images of articular ultrasound. After 4 weeks of~     injection, patients will be asked to come back, and their disease information, disease~     activity score, laboratory results as well as images of articular ultrasound will be~     collected. Finally, these data will be sorted and analyzed.~      Hypothesis: The efficacy and safety of intra-articular injection of tocilizumab is better~     than that of compound betamethasone.~   "
26860|NCT03215394|"~     The Social ABCs is an evidence-based, developmentally informed, caregiver-mediated~     behavioural intervention for toddlers with suspected or confirmed Autism Spectrum Disorder~     (ASD). It is based on principles of Pivotal Response Treatment (PRT, grounded in Applied~     Behaviour Analysis), and responsive parenting. The two key targets of this program are~     functional verbal communication and positive caregiver-child affect sharing. This~     intervention takes place in the context of play and daily routines, and in all contexts is~     made to be fun.~      In both a pilot study and a recently completed randomized control trial, toddlers whose~     caregivers received training in the Social ABCs intervention showed significant gains in~     early language development (both responsivity and initiations), increased child smiling~     (mediated by parent smiling), and a trend toward increased social orienting (one important~     manifestation of social attention).~      Despite the social-communication benefits demonstrated through the Social ABCs, the research~     team is also motivated to foster the attentional abilities of toddlers with emerging ASD in~     response to compelling evidence that early attentional control abilities may play a central~     role in the emergence of ASD. Based on this knowledge, the current study targets not only~     social-communication challenges and affect sharing (as per the existing Social ABCs~     intervention), but also attentional control in toddlers with suspected or confirmed ASD.~     Using a structured, computerized attention-training protocol, this RCT evaluates the impact~     of supplementing the standard Social ABCs intervention with pre-intervention attentional~     control training.~   "
26861|NCT03215381|"~     This is an open-label, single centre exploratory study to analyse brain exposure of AZD1390~     in healthy volunteer males.~   "
26862|NCT03215368|"~     The subjects of the present study were from the Ma'anshan Birth Cohort (MABC) study, a~     prospective pregnancy and birth cohort study designed to examine the relationship between~     prenatal exposure and pregnant outcomes, child health and development.~   "
26863|NCT03215355|"~     This is a feasibility study requiring only three patients to serve as a proof of concept that~     gadoxetate disodium (a liver specific contrast agent) can be used to improve images taken~     just before liver SBRT treatments.~      The hypothesis of this research is that if gadoxetate disodium improves image quality at the~     time of treatment, then it can be used for image guided radiotherapy (IGRT). Image guidance~     is the procedure where the 3D CT image that is used to plan a radiotherapy treatment, is~     aligned to a 3D image taken just before treatment. The better the alignment, the more~     accurate the treatment, which is crucial for high dose treatments such as SBRT.~      This research is important for two main reasons. First, it is much less invasive than the~     standard of care which involves surgically implanting markers in the liver that can move over~     time. The benefit to harm ratio for surgery, compared to an injection, is much more dramatic.~     Furthermore, not all patients are surgical candidates, and therefore in those cases radiation~     oncologists must prescribed a larger area to treat to ensure that none of the cancerous~     region is missed. The drawback to this method is the irradiation of more normal tissue than~     necessary, which although deemed to have a greater benefit than harm, is not ideal. Secondly,~     this research has strong implications in the field of radiation oncology to move towards~     patient oriented radiotherapy treatments. If successful, radiation treatment to the liver~     could be performed in less treatments because of the confidence given to radiation~     oncologists of the cancer location; knowing exactly the healthy liver regions to avoid.~   "
26864|NCT03215342|"~     Acquired brain injury (e.g., traumatic brain injury, brain tumour, brain infections) is one~     of the leading causes of death and disability for children and adolescents. Importantly,~     injuries affecting the brain in childhood or adolescence appear during a time of development~     when the brain is particularly vulnerable. Thus, pediatric acquired brain injury does not~     only impact cognitive functions at the time of injury or onset of disease, but also cognitive~     functions that are yet to develop. Changes in cognitive function, and in particular executive~     dysfunction due to acquired brain injury, cause significant real-life disability, yet solid~     evidence in support of executive functioning interventions for children and adolescents is~     lacking. In the present study different group-based cognitive rehabilitation interventions~     will be compared. The aim of the study is to investigate if a group-based brain training~     intervention is able to improve executive function in children and adolescents after acquired~     brain injury. Efficacy will be assessed immediately after intervention, but also six months~     after the intervention. The project is in line with international research efforts aimed at~     establishing more knowledge about how children and adolescents with brain injuries respond to~     cognitive rehabilitation.~   "
26865|NCT03215329|"~     During general anaesthesia, pulmonary atelectasis has been shown to occur in 85 to 90% of~     patient. Pulmonary atelectasis increases occurrence of postoperative pulmonary complication~     including pneumoniae. Pulmonary atelectasis can be prevented or reversed by alveolar~     recruitment manoeuvres (ARM). Two methods for ARMs have been described. A sustained~     continuous positive airway pressure (CPAP) or a stepwise increase in PEEP.The transient~     increase in intrathoracic pressure during ARMs decreases venous return and increases~     pulmonary vascular resistance. This result in a decrease in right and left ventricular stroke~     volume (SV). Finally, the deleterious hemodynamic effects of ARMs may be exacerbated by~     hypovolemia, heart failure, and in patients with chronic treatment wich impedes~     cardiovascular responses to hypovolemia. At our best knowledge, there is no study which~     compared the hemodynamic effects of ARM using sustained CPAP or stepwise increase in PEEP.~     Consequently, the present study was designed to examine the hemodynamic effects of 2 ARM~     methods in anesthetized patients.~   "
26866|NCT03215316|"~     Expiratory flow limitation (EFL) is defined as a dynamic condition that expiratory flow~     cannot be further increased with higher expiratory driving pressure. Under mechanical~     ventilation, it can cause intrinsic positive end-expiratory pressure (PEEP) and dynamic~     hyperinflation, and be associated with worse clinical outcome. The detection of EFL however~     needs special maneuvers and offline analysis of flow-volume curves, which are infeasible in~     routine practice and cannot be used during real-time monitoring. The investigators propose a~     new and simple approach using flow derived parameters to detect EFL in real time without~     needing any intervention.~   "
26867|NCT03215303|"~     The purpose of this study is to verify the effects of continuous positive airway pressure~     (CPAP) on exercise capacity of children and adolescents with severe therapy-resistant asthma~     (STRA). A randomized, controlled, crossover clinical trial will be conducted. We expect the~     use of CPAP to increase exercise capacity in children and adolescents with STRA.~   "
26868|NCT03215290|"~     Non-anatomical liver resection with appropriate resection margin was regarded as a potential~     curative treatment for selected major hepatic carcinoma due to preserving maximal normal~     liver, especially in cirrhotic patients. But occurrence of cutting surface related~     complications become a main challenge.~   "
26869|NCT03215277|"~     Study to evaluate the efficacy and safety of Bimekizumab compared to Certolizumab Pegol in~     the treatment of subjects with active ankylosing spondylitis (AS)~   "
26870|NCT03215264|"~     The main purpose of this study is to find the best dose of hydroxychloroquine (HCQ) when~     given in combination with regorafenib and entinostat.~   "
26871|NCT03215251|"~     The study evaluates the effectiveness of an Intervention Bundle on Thirst Intensity and Dry~     Mouth among Patients admitted in ICUs. Patients were randomized into two groups -~     Experimental and Control group. Experimental group received intervention Bundle whereas~     control group didn't receive any intervention. Usual care was continued in both the groups.~   "
26872|NCT03215238|"~     Pleth Variability Index (PVI) is a variable that is derived from photoplethysmography (PPG)~     signal. It is used as a surrogate for intravascular volume status intraoperatively. PVI can~     have significant amount of baseline variability which appears to oscillate at a very low~     frequency (5-10 minute cycles). This study aims to investigate the origin of these baseline~     oscillations.~   "
26873|NCT03215225|"~     The aim of the study was to evaluate the root canal treatments performed from 1989 to 1995.~     Type of complication, success, new endodontic diseases and number of success were reported.~     Mean clinical parameters were clinical symptoms and presence/absence of apical radiolucency.~   "
26874|NCT03215212|"~     The study evaluates the effectiveness of ear plug, eye mask and ocean sound on sleep quality~     among ICU patients. 60 patients were randomly allocated to group 1 and group 2 by lottery~     method i.e 30 in each group. Group 1 received earplugs and eye masks on the first night~     followed by washout period on second night and received ocean sound on third night, while the~     group 2 received ocean sound on the first night followed by washout period on second night~     and received earplugs and eye mask on third night.~   "
26875|NCT03215199|"~     This is a randomized controlled trial comparing a web-based psychosocial screening~     application to usual care in a cohort of surgically-treated head and neck cancer patients to~     determine its efficacy in monitoring depression and distress, and prompting necessary~     psychiatry/psychology referrals. In addition, treatment adherence, rehabilitation and return~     to work, primary care utilization, and survival will be monitored.~   "
26887|NCT03215043|"~     First, it will be evaluated whether supplementation of eriocitrin reduces hyperglycemia and~     insulin resistance, significantly reducing the risk of diabetes. The effects of eriocitrin on~     the lipid profile, inflammatory, endothelial, hepatic and renal biomarkers will also be~     evaluated. It is expected that metabolic parameters that constitute risk factors for diabetes~     and associated chronic diseases are expected to be improved by supplementation with~     eriocitrin~   "
26888|NCT03215030|"~     The purpose of this Phase 1 portion of the study is to determine the safety and tolerability~     of TAK-573 monotherapy in participants with refractory multiple myeloma (MM) and Phase 2a~     portion of the study is to provide a preliminary evaluation of the clinical activity of~     TAK-573 monotherapy in participants with refractory MM.~   "
26876|NCT03215186|"~     Prevention and treatment of the reversible childhood blindness, including congenital~     cataracts (CC), has been listed as a significant component of the international programme~     VISION 2020 - the Right to Sight launched by WHO in 1999. However, there is still a lot of~     unsolved problems regarding to CC, especially in developing countries, such as the delayed~     presentation and treatment to the hospitals, the lack of specialized treatment departments,~     and the poor treatment prognosis. With the two children policy opened in China in 2016, many~     CC parents hesitate to have a second child due to the potential high risk of CC. Date on~     detailed clinical characteristics of the CC children, including the demography,~     pregnancy-labor history, and living condition, are crucial for developing the national~     screening strategies of CC in Pregnant women. However, to our knowledge, it still lacks of~     thus large population-based and comprehensive investigations of the characteristics of CC~     children in developing countries.~   "
26877|NCT03215173|"~     This study plans to learn more about how to increase postpartum weight loss and how to~     decrease risk factors for postpartum women at increased risk for diabetes and heart disease.~     The program is delivered using a mobile application (app) and a lifestyle coach. This mobile~     application is developed for women who are at higher risk for diabetes and heart disease.~     Women who have gestational diabetes, (diabetes during pregnancy, or GDM), gestational~     hypertension (high blood pressure), and/or preeclampsia (high blood pressure and protein in~     the urine), and/or small-for gestational-age, and/or preterm (early) delivery during their~     pregnancies have a higher risk for diabetes and heart disease. This mobile application was~     developed using the latest research studies and using the evidence-based Diabetes Prevention~     and Colorado Weigh programs. The goal of the program is to help women lose weight and~     participate in physical activity after delivery.~   "
26878|NCT03215160|"~     There is no definite evidence about the most effective treatment approach in early-stage~     rehabilitation after total knee arthroplasty surgery. The purpose of this study is to~     investigate the effects of mobilization exercises applied with classical exercises on pain,~     joint range of motion, edema, function, quality of life and patient satisfaction in early~     stage rehabilitation after total knee arthroplasty surgery.~   "
26879|NCT03215147|"~     The investigators assess the prevalence of airway disease associated with idiopathic~     pulmonary fibrosis in Korea, and evaluate the effect of these airway diseases on the symptoms~     and quality of life of patients with idiopathic pulmonary fibrosis.~   "
26880|NCT03215134|"~     This uncontrolled pilot seeks to develop a novel intervention based on Compassion Focused~     Therapy (CFT), that reduces self-criticism and improves psychological wellbeing. The~     researchers aim to assess the the acceptability and feasibility of providing such an~     intervention within a primary mental health care service; and a preliminary indication of the~     the effectiveness of this intervention?~   "
26881|NCT03215121|"~     During induction of anesthesia in children, the investigators have observed significant~     variability in mask holding technique at our institution among different anesthesia~     practitioners. Some hold the face mask using one hand and others use two hands. The aim of~     our study is to comparatively evaluate the extent of airway obstruction in children whilst~     anesthetic mask is held with one hand with jaw thrust versus mask held using two hands with~     chin lift by anesthesia provider during induction of anesthesia in children.~   "
26882|NCT03215108|"~     The aim of this animal study is determining the technical feasibility of the novel~     flower-type covered self-expandable metal stent (F-CSEMS) and investigating whether the novel~     flower-type covered self-expandable metal stent (F-CSEMS) could prevent cholecystitis and~     pancreatitis, comparing with conventional covered self-expandable metal stent (C-CSEMS).~   "
26883|NCT03215095|"~     The purpose of this study is to find out what effects, good and/or bad, a drug called~     durvalumab combined with Thyrogen-stimulated RAI, has on the patient and thyroid cancer.~     Durvalumab is a drug that has been developed to activate the immune system by blocking a~     protein called programmed death ligand-1 (PD-L1) that can be present on tumor and normal~     cells, including immune cells.~   "
26884|NCT03215082|"~     The aim of this research program is to 1) Evaluate potential problems with vision, inner~     ear-eye reflexes and deficits of processing eye information that occur following TBI; and 2)~     Evaluate treatment programs for individuals with eye and inner ear problems that persist for~     greater than 10 days following injury.~      This study will include 465 youth and young adults (aged 6-30 years old) who sustain a TBI of~     any severity. An initial evaluative phase using the best available technology to evaluate eye~     and inner ear function will be performed, and compared with typical tests that are used in~     the clinic. If symptoms and functional problems remain 10 days after injury, participants~     will be randomly placed into a treatment group (including eye movement, inner ear-eye reflex~     and attention exercises as per our pilot studies) or a control group (typical~     rehabilitation). Success will be measured in terms of return to sport (mild TBI), achievement~     of goals (moderate and severe TBI) and quality of life. It is expected that this program will~     inform clinical practice and future research leading to a treatment program in TBI that~     includes multiple components.~   "
26885|NCT03215069|"~     Double-blind, parallel arm, randomized controlled trial, in which non-lactating women with~     recent GDM who are between 6 to 36 months postpartum to be randomized to either empagliflozin~     10 mg daily or matching placebo. The duration of treatment will be 48-weeks. Beta-cell~     function will be assessed by Insulin Secretion-Sensitivity Index-2 (ISSI-2), measured on oral~     glucose tolerance test (OGTT) at baseline, 24-weeks, 48-weeks, and after a 4-week washout.~   "
26886|NCT03215056|"~     This is a randomised, double-blind, multicentre, placebo controlled study to evaluate the~     safety and efficacy of methoxyflurane (Penthrox®) for the treatment of acute pain in children~     and adolescents from 6 to less than 18 years of age (presenting to an Emergency Department~     with minor trauma). It is conducted as part of the Paediatric Investigation Plan (PIP) agreed~     with the Paediatric Committee (PDCO) of the European Medicines Agency (EMA).~      The study aims to provide evidence under blinded controlled conditions that Penthrox is safe~     and effective in patients aged 6 to less than 18 years presenting to ED with pain associated~     with minor trauma.~   "
26889|NCT03215017|"~     A randomized controlled trial (RCT) in patients who underwent sphincter preserving surgery~     due to rectal cancer. The study will analyze the effect of Transanal irrigation (TAI) and~     medication that can help control of the bowel movement in patients with low anterior~     resection syndrome.~   "
26890|NCT03215004|"~     Clinical specimens are required from HIV positive individuals with viremia controlled by~     antiretroviral therapy to complete process development for a genetically modified autologous~     T cell product, AGT103-T. The product will be used in a subsequent early stage clinical trial~     in subjects with chronic HIV disease and viremia suppressed by antiretroviral therapy as the~     initial step in testing a functional cure for HIV disease. Enrolled participants provide a~     venous blood specimen (approximately 25mL) to determine their level of HIV-reactive CD4+ T~     cells. Subjects with positive T cell responses will be asked to undergo leukapheresis and~     their clinical specimens will be used to validate and qualify the AGT103-T cell product.~   "
26891|NCT03214991|"~     The aim of this study is to determine the usefulness of circulating tumor DNA as a prognostic~     factor in patients with pancreatic cancer.~   "
26892|NCT03214978|"~     The prevalence of papillary thyroid micro-carcinoma (PTMC) increased rapidly in recent years~     but the design of treatment is controversial because a majority of them are indolent.~     Therefore, to recognize which PTMC is of strong progressive potential which should be~     operated is very crucial. Fine needle aspiration (FNA) pre-surgery could obtain tumor cells~     which could be used in genetic analysis. To date, there is no specific way to evaluate the~     aggressive potential of a PTMC pre-surgery. So, the purpose of this proposal is to screen~     genetic mutations of the aggressive type of PTMC. The candidate did a whole exome sequencing~     on 3-3 pairs of PTCs and found some SNPs and Indels in TP53、TTN、PDF. To further investigate~     those mutations, a target region sequencing will be done in 40 pairs tumor samples. And~     ultimately to find out which genetic event could contribute to strong aggressive potential of~     PTC. The mutations details would be design to test the FNA and tissue sample to validate if~     the genetic testing based on FNA is reliable. The gene test results would be evaluated with~     sonographic features to predict the potential of small thyroid carcinoma before surgery. This~     project won't aim to study the function and mechanism of specific genes but just screen them~     out. So, the fund would cover the fee of the whole study and this study is very likely to~     achieve the goal.~   "
26893|NCT03214965|"~     This study is designed to compare the knowledge, satisfaction and self-esteem of kidney~     transplanted adolescents measured through questionnaires between two groups: patients~     undergoing conventional treatment with no other intervention versus patients undergoing~     conventional treatment and receiving additional educational and consultative actions using a~     closed facebook group.~   "
26894|NCT03214952|"~     The purpose of this study is to evaluate the safety and efficacy of vonoprazan tablets~     (Takecab tablets) in patients with gastric ulcer, duodenal ulcer, and reflux esophagitis in~     the routine clinical setting.~   "
26895|NCT03214939|"~     The purpose of this work: to assess the tolerability and effectiveness of the autogemotherapy~     method on the basis of autologous antigen-activated dendritic cells in the treatment of~     patients with colorectal cancer.~      This technology is intended for complex treatment of patients with colorectal cancer and is~     aimed at preventing the occurrence and treatment of secondary foci. The need for this~     technology is justified by the widespread occurrence of colorectal cancer, a decrease in the~     average age at onset of the disease, and the chemoresistantness of locally advanced forms of~     cancer.~   "
26896|NCT03214926|"~     Recently, Mark Morris Dance Group, and created Moving Through Glass (MTG), a project that was~     funded by Google, as a portable, round-the-clock extension of the internationally acclaimed~     Dance for Parkinson's Disease (PD)®. When a user activates Glass, participants can choose~     from a variety of different exercises, like warm me up or balance me. Once selected, they~     see the founder instructors of the Dance for PD® projected in front of them.~      As a single site research study at Syracuse University, researchers are conducting the pilot~     phase of the research project.~      The purpose of the study is to investigate the impact of MTG on quality of life and motor~     functions (i.e. balance, gait, fall efficacy). Participation in the study required three~     visits to Women's Building in a period of four weeks and about 1-3 hours of the participant's~     time at each visit. During the first visit, 1 participants reviewed the consent form,~     completed Montreal Cognitive Assessment (MOCA) and if qualified participated in a~     face-to-face interview. Participants were given survey package to fill out at home and were~     given a week to complete all the paperwork. On the second visit, they returned the completed~     survey package, were given physical assessments and were taught how to use Google Glass. The~     participants left with Google Glass, log sheet, and survey package. After 3 weeks,~     participants came to Women's Building for the last visit and the physical assessments were~     repeated, followed by an exit interview.~   "
26897|NCT03214913|"~     To evaluate two different strategy of fluid resuscitation in sepsis patients~   "
26898|NCT03214900|"~     This is a prospective cohort, one center. twenty patients who will undergo percutaneous stent~     implantation with everolimus eluting stent will be include. The primary endpoint was the~     correlation between the change (baseline vs. 1 week) in the number of circulating endothelial~     progenitor cells and in cell functionality following an everolimus eluting stent implantation~     with the grade of neointimal hyperplasia measured by optical coherence tomography~   "
26899|NCT03214887|"~     The purpose of this study is to evaluate the safety and efficacy of hyaluronan combined with~     autologous bone marrow mononuclear cells for the treatment of critical PAOD patients.~   "
26900|NCT03214874|"~     The study will evaluate the within-subject variability of 20mg ER torsemide as compared to~     20mg IR torsemide (Demadex) in fully replicate double-crossover trial in healthy volunteers,~     who are consuming a high-salt diet (300 mmol/day). The study will also evaluate the effects~     of ER torsemide and IR torsemide on 24h sodium excretion and total urinary excretion.~   "
26901|NCT03214861|"~     This is an analysis conducted in the Nurses Health Study and the Health Professional~     Follow-Up Study, both prospective cohort studies, where the investigators systematically~     investigated the association between carbohydrate quality using a variety of metrics in~     relation to coronary heart disease. This was a secondary data analysis of previously~     collected data in both cohorts.~   "
26902|NCT03214848|"~     This is a randomized prospective study evaluating the impact of a brief contraceptive~     education intervention with optional referral for financial counseling on post abortion~     long-acting reversible contraceptive (LARC) uptake and contraceptive use at three months post~     abortion.~   "
26906|NCT03214796|"~     The aim of this study is to investigate the effect of albumin infusion on oxidative albumin~     modification, on plasma thiol status and on albumin binding capacity for DS in patients who~     routinely receive albumin infusion for various indications and to relate these findings with~     neurohumoral parameters, bacterial products such as endotoxin, and neutrophil function~   "
26907|NCT03214783|"~     The purpose of this study is to explore the facial characteristics asscosiated with the~     increased risk of coronary artery diseases. The secondary purpose is to evaluate the~     diagnostic efficacy of appearance factors for coronary artery diseases.~   "
26908|NCT03214770|"~     This is a randomized clinical study. 48 subjects with a confirmed diagnosis of deep carious~     molars without pulpal lesions were randomized to one of two treatments: Patients treated with~     Light-cured calcium silicate (Theracal) liner, or treated with light-cured calcium Hydroxide~     (Biner LC) liner. Both two Treatments are with the step-wise excavation Technique.~      Treatment will be done at baseline, collecting dentin sample before application of liner~     material, then patients will be dismissed with Resin-modified Glass Ionomer restoration and~     recalled after 6 months. Re-entry of tooth required for completing the step-wise excavation~     technique collecting the second dentin sample after this time interval (6 months) and~     permanently restore tooth with composite restoration. Dentin samples will be~     microbiologically analyzed and the results will be statistically calculated.~   "
26909|NCT03214757|"~     Dilated cardiomyopathy is a heart muscle disorder characterized by systolic dysfunction and~     dilation of the left or both ventricles.Dilated cardiomyopathy can develop in people of any~     age or ethnicity, although it is more common in male than female persons occurring at a ratio~     of about three to one in male to female persons.~      Dilated cardiomyopathy is the predominant cause of cardiomyopathy in pediatric populations.~     Annual incidence in pediatric populations has been reported to be much lower than one to one~     hundred seventy thousand in the United States and one to one hundred forty thousand in~     Australia.~      Although pediatric dilated cardiomyopathy has a lower annual incidence than adult dilated~     cardiomyopathy, the outcome for pediatric dilated cardiomyopathy patients is particularly~     severe.~      Dilated cardiomyopathy is the most frequent cause of heart transplantation in pediatric~     patients. Data from international pediatric dilated cardiomyopathy registries indicate that~     the rates of death or heart transplantation over one and five year periods were thirty one~     percent and forty six percent, respectively.~      Onset of dilated cardiomyopathy is usually insidious but may be acute in as many at twenty~     five percent of patients. Approximately fifty percent of patients with dilated cardiomyopathy~     have a history of preceding viral illness.~   "
26910|NCT03214744|"~     Rapid Versus Slow Entral Feeding Advancements on Clinical Outcomes of Preterm Infants~   "
26911|NCT03214731|"~     This is a multi-center, randomized, double-blind, placebo-controlled study. Study subjects~     are class III, IV, V, III+V, IV+V lupus nephritis patients, according to ISN/RPS 2003~     classification of LN, with active lesion needing corticosteroid in combination with~     immunosuppressant therapy.~      Subjects who meet the eligibility criteria during screening will be randomized to 1 of 3~     treatment groups in a 1:1:1 ratio: 25mg bid artesunate, 50mg bid artesunate or placebo plus~     standard of care (prednisone plus mycophenolate mofetil ［MMF］) for 6 month.~   "
26912|NCT03214718|"~     The suppression of the immune system creates a permissive environment for development and~     progression of cancer. One population of immunosuppressive cells that have become the focus~     of intense study is myeloid derived suppressor cells , immature myeloid cells able to induce~     immune-escape, angiogenesis, and tumor progression. Two different subpopulations have been~     identified and studied: granulocytic and monocytic myeloid derived suppressor cells with a~     different immunophenotype and immunosuppressive properties~   "
26913|NCT03214705|"~     Prospective evaluation of patients with subarachnoid hemorrhage (SAH) will be done by~     computed tomography angiography (CTA) and perfusion imaging (CTP) for any correlation between~     degree of vasospasm and perfusion deficit as well as evaluating the ability of CTP to predict~     delayed cerebral ischemia.~   "
26914|NCT03214692|"~     Oxidative processes increased in patients with renal failure and especially patients with end~     stage renal failure on dialysis. Oxidative stress plays a role in renal damage and also on~     cardiovascular disease, atherosclerosis, which can accelerate renal damage. Gum Arabic is~     claimed to have antioxidant effect and this will decrease the harmful effect of the free~     radical on patient on hemodialysis. In this study investigators are aiming to see the effect~     of Gum Arabic on Oxidative Stress and inflammatory markers in patients on regular~     hemodialysis.~   "
26915|NCT03214679|"~     The proposed study will examine the feasibility, acceptability, safety, effectiveness, and~     cost of an Accessible Care intervention for engaging people who inject illicit drugs (PWID)~     in hepatitis C care. Accessible Care for PWID is low-threshold care provided in programs~     designed specifically for PWID where they can comfortably access care without fear of shame~     or stigma. Accessible Care will be provided by co-locating a hepatitis treatment provider,~     together with a Hepatitis C Care Coordinator (HCCC), on-site at a collaborating needle~     exchange program. The proposed study will compare the effectiveness of Accessible Care with~     Usual Care (referrals to existing services) in facilitating linkage, engagement, and~     retention of PWID in care for hepatitis C, addiction, and HIV prevention. The primary outcome~     is sustained virologic response, which constitutes virologic cure. Substance use and HIV and~     HCV risk behaviors are secondary outcomes.~   "
26916|NCT03214666|"~     This is a single center Phase I/II clinical trial of CD16/IL-15/CD33 (161533) tri-specific~     killer cell engager (TriKE) for the treatment of CD33-expressing high risk myelodysplastic~     syndromes, refractory/relapsed acute myeloid leukemia or advanced systemic mastocytosis. The~     hypothesis is that 161533 TriKE will induce natural killer cell function by targeting~     malignant cells as well as CD33+ myeloid derived suppressor cells (MDSC) which contribute to~     tumor induced immunosuppression. Because CD16 is the most potent activating receptor on NK~     cells, this single agent may induce a targeted anti-CD33+ tumor response.~   "
26917|NCT03214653|"~     This study aimed to compare the effect of target-controlled infusion of propofol and~     sevoflurane as maintenance of anesthesia to intraoperative hemodynamic profile of renal~     transplant recipient~   "
26918|NCT03214640|"~     We hypothesize that the Rivanna Accuro or similar U/S device would reduce time to success of~     identifying epidural and/or intrathecal spaces as compared to conventional palpation method.~   "
26919|NCT03214627|"~     Fresenius Medical Care has developed a computer software programme called the Anaemia Control~     Management (ACM) software to assist in the anaemia management of patients with chronic kidney~     disease (CKD) undergoing hemodialysis. This trial is designed to assess the effectiveness of~     this ACM software on anaemia management in routine clinical practice. However, all ultimate~     decisions on therapeutic or diagnostic procedures, treatments, management of the disease, or~     resource utilisation will be at the discretion of the Investigator. The trial consists of a~     retrospective (historical) control period and a prospective (going forward) period. During~     the prospective period, the ACM will be used to assist the Investigators' decision making and~     will help the Investigators to administer a personalised intravenous (IV) iron and red blood~     cell stimulating agent (ESA) therapy, whereas treatment according to standard of care will be~     documented retrospectively for the same patients during the retrospective period of the~     trial. Thus, patients can serve as their own control.~   "
26920|NCT03214614|"~     The study is a Phase I, randomized, double-blind, placebo-controlled study evaluating~     multiple ascending oral doses of GLPG2451 and the combination of GLPG2451 and GLPG2222 given~     for 14 days in healthy male subjects.~      The purpose of the study is to evaluate the safety and tolerability of multiple ascending~     oral doses of GLPG2451 given to healthy male subjects compared to placebo, as well as of~     multiple oral doses of the combination of GLPG2451/GLPG2222 compared to placebo.~   "
26921|NCT03214601|"~     The purpose of this study is to conduct an early clinical evaluation of the Relay Branch~     System, which will provide initial insight into the clinical safety and function of the~     device.~      This Early Feasibility Study (EFS) will assess the safety and effectiveness of the device at~     the index procedure and at 30-day follow-up. The study will evaluate the delivery and~     deployment of the device, patency of branches and branch vessels, and exclusion of the aortic~     pathology. The data will help determine if modifications need to be made to the device, the~     procedural steps, operator technique, or the indications for use.~   "
26922|NCT03214588|"~     The purpose of this study is to evaluate the efficacy of TAK-831 versus placebo on upper~     extremity (arm and hands) motor function and manual dexterity. This study will also evaluate~     the efficacy of TAK-831 versus placebo on activities of daily living (ADL) and other~     secondary assessments.~   "
26923|NCT03214575|"~     Background: Central venous catheter (CVC) insertion is a very common procedure in the~     intensive care setting. A recent international guidelines advocated the use of ultrasound for~     routine internal jugular CVC insertion. The needle navigation technology is a new innovation,~     also known as guided positioning system (GPS) which allows clinician to visualize the needle~     position and trajectory in real time as it approaches the target. We hypothesised that the~     use of GPS would increase success rate and decrease performance time in vascular access~     procedures.~      Objectives: To compare the success, efficacy and safety of the procedure using the ultrasound~     guidance (UG) with conventional versus GPS method.~      Methods: This was a prospective randomized controlled study in a single centre - intensive~     care unit. 100 patients were randomized into two groups (50 each each). Subjects would~     receive CVC insertion via internal jugular vein using ultrasound guidance out of plane~     approach by conventional versus GPS method. Outcomes measured were the procedure efficacy,~     safety, level of operators' experience and their satisfaction.~   "
26924|NCT03214562|"~     The goal of this clinical research study is find the highest tolerable dose of venetoclax~     that can be given in combination with a type of chemotherapy called FLAG-IDA to patients with~     acute myeloid leukemia (AML). FLAG-IDA chemotherapy includes fludarabine, cytarabine,~     idarubicin, and filgrastim.~      The safety of this drug combination will also be studied.~      This is an investigational study. FLAG-IDA chemotherapy is FDA approved and commercially~     available for the treatment of AML. Venetoclax is FDA approved and commercially available for~     the treatment of chronic lymphocytic leukemia. It is considered investigational to use~     venetoclax to treat AML. The study doctor can explain how the study drugs are designed to~     work.~      Up to 56 participants will be enrolled in this study. All will take part at MD Anderson.~   "
26925|NCT03214549|"~     The aim of this study is to evaluate tooth sensitivity and marginal adaptation of porcelain~     laminates veneers prepared with modified gull wing preparation and conventional preparation.~   "
26926|NCT03214536|"~     In spine surgery postoperative pain can often be severe and difficult to treat.With the use~     of ultrasound, the performance of plane blocks and other techniques like root blocks, facet~     infiltration have become possible without the use of either unreliable  pop-techniques or~     the use of x-ray.The erector spinae block was recently described as a safe and simple and~     safe technique for neuropathic pain and acute post surgical pain, with effect on the dorsal~     rami of the spinal nerves and with promising results. In this observational pilot study we~     want to test the influence of these to blocks on the postoperative pain and opioid~     consumption after spine fusion.~   "
26927|NCT03214523|"~     Sleep is a clearly necessary neurobiologic process that influences innumerable aspects of~     basic daily functions, physical health, and mental well-being. Recent literature shows that~     college students across the country are experiencing high rates of sleep deprivation.~     Interestingly, some recent studies have implicated this sleep loss in contributing to weight~     gain that occurs in the first year of college, also known as the freshman fifteen. Rates of~     depression and other mental health issues, which are closely connected to sleep disturbances,~     are also on the rise in college campuses. The majority of the sleep data obtained in this~     population has been via questionnaires and self report, and the studies usually include~     college students at all seniority levels (e.g., freshmen, sophomores, seniors). Here, the~     investigators outline a novel study investigating how sleep time changes in college freshman,~     and how it relates to multiple different aspects of their health and functioning over the~     course of one quarter.~      As technology has advanced, the ability to easily obtain objective measurements of different~     health parameters has increased dramatically. The investigators plan to use wireless~     actigraphy devices to measure sleep over a baseline seven day period in college-bound UCSD~     students prior to matriculation, and for 2 additional seven day periods during the first~     quarter of college. To the knowledge of the investigators, this is the first study to~     directly measure sleep time in college freshman in their normal environment. Effects of sleep~     time loss will be evaluated through multiple different metrics of physical and mental health.~     Given the recent link between sleep disturbances and weight gain in college freshman, the~     investigators will plan to measure weight changes prior to entering college and at two~     different time points through the first quarter. The investigators will use the PSQ-9 and~     GAD7 batteries as measures of mental health, obtained at the same time points as the sleep~     and weight information. As one of the primary consequences of sleep deprivation is on~     neurocognition in the daytime, the investigators plan to measure vigilant attention using~     psychomotor vigilance testing (PVT) as well. Screen time use has recently been targeted as a~     possible contributor to sleep loss in adolescents as well as adults and is something the~     investigators will attempt to measure as well using a smartphone application. Finally, this~     project will test the efficacy of a one hour sleep education intervention on improving total~     sleep time.~      To the knowledge of the investigators, no other studies have closely examined how total sleep~     time changes during the first year of college in freshman in relationship to weight and~     mental health parameters, nor has PVT been done in this context. Additionally, with the~     increasing concerns regarding screen time use in adolescents and young adults, this study~     provides prime opportunity to examine this issue in the context of sleep.~   "
26928|NCT03214510|"~     The goal of this clinical research study is to compare the quality of recovery for patients~     who receive different standard pain control treatments after surgery on the liver.~     Researchers want to learn which method helps people to recover more completely and more~     quickly after surgery.~      The 2 kinds of pain control are epidural pain management and transversus abdominus plane~     (abdominal) block.~      This is an investigational study. Epidural pain management and transversus abdominus plane~     block are FDA approved and commercially available. Comparing the pain management treatments~     is being done for research purposes.~      Up to 96 participants will be enrolled in this study. All will take part at MD Anderson.~   "
26929|NCT03214497|"~     The goal of this study is to compare the oropharyngeal leak pressure of the Protector~     Laryngeal mask with the Supreme laryngeal mask. Other secondary parameters will be studied.~   "
26930|NCT03214484|"~     This pathology, DMLA, whose evolution is chronic, requires regular follow-up and care (IVTs)~     over a long period (several months or even years).~      Increasing the number of patients to be followed and treated poses increasing problems for~     ophthalmologists to ensure regular follow-up of patients, followed by a need for satisfactory~     functional results.~      Moreover, this regular follow-up imposes enormous constraints on patients and their families~     (some children or patients are still working).~      Studies are beginning to emerge on the reliability of patient follow-up in telemedicine. The~     use of a measure of visual acuity by patients, Electronic Tablet (TE) or computer (O), and at~     home, seems a logical step to help us improve the quality of patient follow-up while spacing~     controls.~      The aim of our study is thus to demonstrate that the measurement of the VA performed by TE or~     O is reliable. Indeed, during the follow-up of the patients, in the case where the patient's~     AV decreases, and whatever the reason~   "
26931|NCT03214471|"~     The aim of this trial is to evaluate the effect of a post-surgery 12-month lifestyle~     intervention compared to usual care upon post-surgery weight loss and changes that occur in~     body composition (relative amounts of body fat, muscle and bone), physical fitness and~     activity levels, diseases linked to obesity (e.g. diabetes, high blood pressure, high~     cholesterol level, sleep apnoea) and health-related quality of life (HRQoL) over a 12-month~     period.~   "
26932|NCT03214458|"~     The investigators are looking at the effect of humidified nasal high-flow with oxygen~     (HNHF-O2) on air exchange during exacerbations of COPD. HNHF-O2 therapy may have beneficial~     effects in patients with severe breathing impairment that results in low oxygen in the blood.~     Some studies show that patients with low blood oxygen levels who use HFNC oxygen have lower~     rates of needing mechanical ventilation.~   "
26933|NCT03214445|"~     the patient (n=60), with at least 3 composite resins with marginal defects , randomized into~     3 groups A=Sealed with flow composite reinforced with nanofiller , B= Sealed with resin~     sealant , and C=Control, without intervention , and then assessed by the FDI criteria for~     clinical performance and longevity of restorations~   "
26934|NCT03214432|"~     Background:~      Patients with mild traumatic brain injury can to some extend experience long-term physical,~     cognitive, social and behavioral deficits, which have serious implications for employment~     trajectories and financial independence. These deficits have shown to be more pronounced in~     women. High socio-economic position such as income, level of education and employment status~     before the accident have shown to affect return to work. But also cohabitation status,~     ethnicity and health are important factors. Previously studies are typically self-report~     studies, and are often small and may suffer from selection bias due to patient nonresponse.~      Aim:~      The aim of this study is to describe no return to work among patients with mild traumatic~     brain injury in Denmark and to examine how factors such as age, gender, cohabitation status,~     socio-economic and pre-injury health factors affect no return to work up to 5 years~     post-injury.~      Hypothesis:~      We hypothesize that most patients with mild traumatic brain injury return to work within work~     6 months post-injury, and that patients with mild traumatic brain injury injury receive more~     social transfer payments compared to the general population.~      Additionally, we hypothesize that low socio economic position, comorbidities and being single~     are associated with prolonged no return to work.~      Methods:~      The present study is an observational national register-based cohort study with long-term~     follow up of patients with mild traumatic brain injury from 1st of January 2008 - 31st of~     December 2012 in Denmark. Patients aged 18-60 years diagnosed with concussion from 1st of~     January 2003-31st of December 2007 in the national patient register will be included in the~     study. Data will be retrieved from several national databases, including the DREAM database~     containing data on social benefits and reimbursements.~      Primary outcome is no-return to work (nRTW) due to any cause and the following four secondary~     outcomes are graded and should be regarded as a continuum ranging from health related nRTW,~     limited nRTW, permanently nRTW and mortality.~      The results will be published as two separate scientific articles.~   "
26935|NCT03214419|"~     Radioisotopic and wire localizations suffer from several limitations. These techniques add~     another procedure prior to surgery, can be uncomfortable and entail additional cost.~      The aim is to develop a novel technique of breast tumor localization using preoperative~     magnetic resonance imaging (MRI) and breast optical scanning.~      Patients with diagnosis of breast cancer who have had a preoperative MRI and 3D optical scans~     are included.~      Optical scanning is done preoperatively and intraoperatively after tumor localization was~     marked on the breast using radioisotopic technique.~      The MRI is then adjusted with the intraoperative optical scan to match the breast position at~     the time of surgery.~      The investigators evaluate the efficiency for localization of breast lesion of the novel~     technique by comparison with radiosiotopic technique.~   "
26936|NCT03214406|"~     Parallel, double blind, randomized, IRB-approved study involving approximately 160 subjects~     to complete. Subjects were randomly assigned to either the test product (Arm & Hammer Advance~     White Brilliant Sparkle) or the control (Crest Cavity Protection Regular) based on baseline~     mean whole-mouth plaque and gingival scores and age.Subjects brushed with their assigned~     dentifrice 2X daily and were evaluated for gingivitis, bleeding and plaque at Baseline and~     after 4-, 8-, and 12-weeks of product use.~   "
26937|NCT03214393|"~     Relation of certain maternal serum antibodies to Doppler changes will be studied in cases~     suffering from hypertension with pregnancy.~   "
26938|NCT03214380|"~     The purpose of this study is to compare LY900014 to insulin lispro, both in combination with~     insulin glargine or insulin degludec, in participants with type 2 diabetes (T2D).~   "
26939|NCT03214367|"~     The main purpose of this study is to evaluate the efficacy of the study drug LY900014~     compared to insulin lispro, both in combination with insulin glargine or insulin degludec, in~     adults with type 1 diabetes (T1D).~   "
26940|NCT03214354|"~     The aim of this study to evaluate the safety and efficacy of a nonmyeloablative conditioning~     regimen for allogeneic hematopoietic stem cell transplantation (HSCT) in pediatric patients~     with sickle cell disease (SCD) who have a matched related major ABO-incompatible donor. The~     nonmyeloablative regimen will use alemtuzumab, total body irradiation (TBI) and sirolimus for~     immune suppression. This study will expand the access of HSCT for patients with SCD who are~     currently not eligible because of donor restrictions.~   "
26942|NCT03214328|"~     Intrauterine fetal death (IUFD) is defined as the occurrence of fetal death at >20 weeks'~     gestation. IUFD affects about 1 in 160 pregnancies (6-7 per 1000 births). Optimal diagnostic~     evaluation for cases of IUFD is generally based on extensive protocol testing i.e. maternal~     and fetal blood tests, fetal bacteriology, cytogenetic analysis, autopsy, and placental~     examination. This extensive protocol testing may vary in clinical practice and interpretation~     of the results is rarely performed by multidisciplinary staff to establish cause of death.~     These findings are related to the fact that there are very few epidemiological studies to~     validate optimal protocol, no French recommendations on this subject, and a relative lack of~     pathologists with expertise in perinatal pathology. Only, one recent prospective study from~     the Netherlands has concluded that extensive protocol testing should be redefined and some~     diagnostics tests may only be performed with suggestive clinical circumstances. However these~     recommendations may not be applicable to all populations and countries. To date, there are no~     French published series on IUFD to evaluate causes of death in France and thereafter to~     better define optimal diagnostic evaluation tests. Improvement in prenatal diagnosis in~     France may contribute to detection of the vast majority of severe chromosomal abnormalities~     and malformed fetuses and particularly those at risk of death. Retrospective cohort~     unpublished data on IUFD from Lille and Caen have reported exceptional deaths attributable to~     chromosomal or malformation abnormalities. In fact in these two series, most deaths were~     related to placental diseases or fetal growth retardation. The hypothesis is that extensive~     protocol testing is not helpful in clinical practice and selective protocol testing focused~     on specific risk situations can be as efficient.~   "
26943|NCT03214315|"~     The project aims at developing and structuring a network of clinicians, pathologists, and~     scientists, from the Grand Ouest area, most of them already involved in prostate cancer~     management and research.~      Patients treated by radical prostatectomy will be recruited within the ReSCaP network of~     clinicians, with centralized database and standardized bio-resource collection, including~     prostate and adipose tissue samples. Seven clinical centers will participate to the network,~     6 recruiting mainly Caucasian patients, and 1 from the French West Indies recruiting mainly~     African Caribbean patients. After 18 months, 1000 patients will be included.~      The main goal is to study the relationships between adipose tissue/lipids and prostate cancer~     aggressiveness. In fact, adipose tissue is likely to be involved in cancer progression at~     many levels: abdominal obesity has been associated with aggressive disease, and~     poly-unsaturated fatty acids (PUFAs), as well as cytokines produced by adipocytes~     (adipokines) have an impact on cancer cells growth and migration in vitro. Moreover, adipose~     tissue is the preferential site of storage of persistent organic pollutants with estrogenic~     properties, which could impact cancer progression.~      The study will analyze the association between adipose tissue (distant from the prostate)~     composition and cancer aggressiveness. Among the 1000 patients, 100 aggressive tumors will be~     selected according to the d'Amico criteria (Gleason score 8 or more and/or pT3 tumors). They~     will be matched with 100 potentially indolent prostate cancers (Gleason 6 or less, and PSA~     less than 10, and pT2 stage on the surgical specimen). These 200 adipose tissue samples will~     be analyzed for 1/ the lipid profile, including the fatty acid composition, particularly~     PUFAs, that reflects past dietary fat intake, 2/ adipokine expression, and 3/ tissue~     concentrations of persistent organic pollutants belonging to the class of organochlorine~     pesticides with hormone-like activity.~   "
26944|NCT03214302|"~     The majority of childbearing age women with hepatitis B virus infection were still in the~     immune tolerance period. Our recent research had shown that most puerperae after delivery had~     elevated ALT level. However, there is no withdrawal time recommendations after childbirth at~     present.Through the study of hepatitis occurrence after delivery and drug withdrawal, the~     investigators explore the withdrawal time of antiviral treatment during pregnancy.~   "
26945|NCT03214289|"~     The investigators hypothesize that perturbations in the intestinal microbiota following~     allogeneic hematopoietic stem cell transplantation (HSCT) are essential for the development~     and propagation of acute graft-versus-host disease. Therefore, modification of HSCT~     recipients' gut microbiota using fecal transplantation from a healthy donor could be used to~     treat gut acute GVHD.~      The study evaluates safety and feasibility of fecal microbiota transplantation with frozen~     capsules from healthy donors for the treatment of steroid resistant or steroid dependent~     acute graft-versus-host disease of the gut.~   "
26946|NCT03214276|"~     Endurance performance during high intensive exercises is mainly determined by the capacity of~     the aerobic metabolism. It generally induces muscle fatigue defined as the reversible decline~     in skeletal muscle contractile performance. Fatigue is multifactorial and is often associated~     with many physiological parameters including reduced neural input and disruptive metabolic~     changes in skeletal muscles such as lactic acidosis and the production of oxidative free~     radicals. Moreover, it could lead to oxidative stress as a result of an imbalance between~     reactive oxygen species (ROS) production and intrinsic antioxidant defense.~      To alleviate oxidative stress, some ergogenic strategies have been tested. Numerous studies~     have reported that different types of supplementation such as selenium, vitamin E, vitamin C~     or polyphenols were of interest to protect against these mechanisms. Indeed, although some~     studies demonstrated no or harmful effects, most studies observed positive effects of~     antioxidants on oxidative stress or performance. More particularly, polyphenols, have great~     antioxidant capabilities and protective effects and it increases the synthesis and~     bioavailability of nitric oxide (NO)which is well known to be the most important mediator of~     vasodilation. To date, most of the studies exploring the effects of polyphenols on exercise~     investigated several days or weeks of supplementations on vascular, blood parameters (blood~     pressure, NO concentration, oxidative stress markers) or endurance performance. Conflicting~     results are often obtained. Only few studies investigated the effects of a single intake on~     immediate performance and recovery capacity. Therefore, the present work aimed to study the~     effects of an acute intake of a specific profile polyphenols from grape and apple on physical~     performances. More specifically, performance, in the present study, referred to high~     intensity cycling exercise until exhaustion revealing the capacity to maintain a constant~     strong effort hereafter named endurance. The hypothesis was that an acute of polyphenols~     would increase the time to exhaustion during a high intensity cycling exercise.~   "
26947|NCT03214263|"~     Introduction: The medical treatment of inflammatory rheumatic diseases has improved~     dramatically during the last decades primarily due to the introduction of biological disease~     modifying anti-rheumatic drugs (bDMARDs). However, bDMARD treatment failure occurs in 30-40%~     of patients due to lack of effectiveness or side effects. The tools to predict treatment~     outcomes in the individual patient are currently limited. The objective of the present study~     is to identify diagnostic, prognostic and predictive biomarkers, which can be used to 1)~     diagnose inflammatory rheumatic diseases early in the disease course with high specificity~     and sensitivity, 2) improve prognostication or 3) predict treatment effectiveness and~     tolerability for the individual patient.~      Methods and analysis: Observational and translational open cohort study with prospective~     collection of clinical data and biological materials in patients with inflammatory rheumatic~     diseases treated in routine care. Patients contribute one cross-sectional blood sample (i.e.~     whole blood, serum, EDTA-plasma and -buffy coat, and blood in PAXgene RNA tubes) and/or are~     enrolled for longitudinal follow-up upon start of new DMARD (blood sampling after~     0/3/6/12/24/36/48/60 months' treatment). Demographics, disease characteristics, comorbidities~     and lifestyle factors are registered at inclusion; DMARD treatment and outcomes are collected~     repeatedly during follow-up. Currently (June 2017) >5,000 samples from ≈3,000 patients have~     been collected. Data will be analysed using appropriate statistical analyses.~      Ethics and dissemination: The protocol is approved by the Danish Ethics Committee and The~     Danish Data Protection Agency. All participants give written informed consent. Biomarkers~     will be evaluated and published according to REMARK, STROBE and STARD guidelines. Results~     will be published in peer-reviewed medical journals and presented at international~     conferences.~   "
26948|NCT03214250|"~     The main purposes of this study are to learn how effective the study drug combinations are in~     treating patients with metastatic pancreatic adenocarcinoma. The drug combinations are~     APX005M+Nivolumab+Gemcitabine+nab-Paclitaxel, or APX005M+Gemcitabine+nab-Paclitaxel.~   "
26949|NCT03214237|"~     To provide a point-in-time measurement of the oral health of elderly inpatients across the~     trust (elderly defined here as over 70 years). This will provide information about the number~     of teeth, need for restorative and periodontal treatment, and extractions, the health of the~     oral mucosa, quality of any dentures and hygiene of the teeth and dentures.~   "
26950|NCT03214224|"~     The specific objective of this study is to validate the practice of remote pulmonary function~     testing (rPFT) conducted in the home through the use of connected mobile health devices and~     the Penn State Hershey ALS Telemanagement program.~      The second part is a comparison of respiratory outcomes in patients receiving~     telemedicine-guided respiratory assessments monthly vs. those receiving standard of care.~     This is a randomized controlled study which assesses the effects rPFT on respiratory~     outcomes, quality of life, and survival.~   "
26951|NCT03214211|"~     To observe the effiacay, safety and risk of developing diabetes, review the patients chars~     who had administrated or neet to administrate the Pravafenix cap for enroll period, it is an~     prospective observational study that only collect the collectable information follwoing the~     hospital visiting date from enroll point to information collecting date. There is no extra~     visit for this study.~      Observe the data which has been collected for 3 yearts every year from enroll point, if the~     patients agree to be participated in this study and are suitable in inclusion/exclusion~     criteria.~      If the lipid-lowering drugs(only Ezetimibe is possible) is add-on the Pravafenix Cap~     administrating period, it will be analyzed by laering analysis separately. But, the reason~     why it is add-on to have to be written on e-CRF.~   "
26952|NCT03214198|"~     The purpose of this study is to investigate the safety and efficacy of long-term~     administration of Vonoprazan tablets (Takecab tablets) for up to 12 months in the routine~     clinical setting in patients receiving NSAIDs.~   "
26953|NCT03214185|"~     50%-60% of the known causes of recurrent pregnancy loss(RPL) are associated with embryonic~     aneuploidy, such that preimplantation genetic screening (PGS) on embryos acquired by assisted~     reproductive treatment should improve the rate of pregnancy and live birth in those patients.~     In dispute though the clinical application of PGS has been, a series of studies show that the~     new generation of PGS(PGS 2.0), based on blastocyst biopsy followed by whole genome analysis,~     has significantly improved the clinical outcome of IVF treatment. At present, there is still~     a need for the evidence of the use of PGS 2.0 in RPL patients, who may benefit from this~     emerging technology considering the prevalence of genetic abnormalities and the number of~     transferable embryos in this population.~      An earlier single center RCT conducted by our IVF center displayed higher implantation rate,~     clinical pregnancy rate and ongoing pregnancy rate calculated by per embryo transfer(ET)~     cycle in IVF/ICSI+PGS group compared with IVF/ICSI group.~      This multi-center prospective randomized clinical trial is to provide more data to determine~     whether the clinical outcomes are significantly improved per treatment cycle such that~     provide evidence for the application of PGS in RPL patients. Besides, risk factors of PGS~     outcome are to be analyzed from multi-center data to build a model for prediction of the~     possible outcomes of PGS and direction of the clinical choice.~   "
26954|NCT03214172|"~     To estimate the real-world rates of recurrent Venous thromboembolism (VTE), major bleeding~     and all-cause mortality in patients with Cancer-associated thrombosis (CAT) treated with~     rivaroxaban~   "
26955|NCT03214159|"~     The purpose of this study is to evaluate the pharmacokinetics and bioequivalence of Ritonavir~     tablet 100 mg versus NORVIR 100 mg tablet in healthy Chinese adult participants under fasting~     condition.~   "
26956|NCT03214146|"~     The purpose of this study is to evaluate the safety and efficacy of HLA-haplo matched~     Allogenic Bone Marrow Derived stem cells(HYNRCS-Allo-ALS-02 inj), through intrathecal~     delivery for the repeated treatment after 6 months of first treatment in patients with~     amyotrophic lateral sclerosis(ALS).~      This study is an open label, single-dose study to assess the safety and efficacy of HLA-haplo~     matched Allogenic Bone Marrow Derived stem cells(HYNRCS-Allo-ALS-02 inj)~   "
26957|NCT03214133|"~     This study will investigate the effects of dietary supplementation of epicatechin-rich cocoa~     in humans on collagen synthesis and power-based performance outcomes (rate of force~     development).~   "
26958|NCT03214120|"~     The study is to evaluate the effect of modified ultrafiltration on different components of~     Thromboelastography (TEG) in neonates undergoing cardiac surgery using cardiopulmonary~     bypass.~   "
26959|NCT03214107|"~     To prevent hypoglycemia during prolonged exercise (>30 minutes), additional carbohydrate~     intake is frequently required. Carbohydrate intake required will vary with insulin regimens,~     timing and type of exercise as well as starting blood glucose level. In addition to the~     amount of carbohydrate ingested, the timing of carbohydrate intake could also have an impact~     on glucose control during exercise. Therefore, the objective of this study will be to compare~     the efficacy of two snacking strategies to maintain glucose levels in the target range during~     an exercise period in adolescents and adults with type 1 diabetes: 1) a snack containing~     ~0.5g of carbohydrates per kilogram of body weight - rounded to the nearest 5g - given 5~     minutes before exercise; 2) a snack containing ~0.5g of carbohydrates per kilogram of body~     weight - rounded to the nearest 5g - distributed this way: ~40% given 5 minutes before~     exercise, ~30% after 20 minutes of exercise and the last ~30% after 40 minutes of exercise.~   "
26960|NCT03214094|"~     The purpose of this study is to investigate the safety and efficacy of long-term~     administration of Vonoprazan tablets (Takecab tablets) for up to 12 months in the routine~     clinical setting in patients receiving low-dose aspirin.~   "
26961|NCT03214081|"~     The purpose of this study is to evaluate the safety and efficacy of long-term administration~     of Vonoprazan tablets (Takecab tablets) when used as maintenance therapy for reflux~     esophagitis in routine clinical settings.~   "
26962|NCT03214068|"~     The study on evaluation the pattern of TD in MetS population may help us to know the~     magnitude of overlap of these two disease entities and may highlight the importance of~     thyroid function tests in patients with MetS. This can lead to proper planning and adequate~     management strategies, resulting in significant reduction in cardiovascular morbidity and~     mortality due to MetS with TD. Thus, this study aims to evaluate the pattern of TD in~     patients with MetS and to explore the relationship between TD and components of the MetS.~   "
26963|NCT03214055|"~     We aim to evaluate the change in optic nerve sheath diameters as a surrogate of intracranial~     pressure before and after mannitol administration in patients who undergo robot assisted~     laparoscopic radical prostatectomy with pneumoperitoneum and Trendelenburg position.~   "
26964|NCT03214042|"~     To conduct a prospective, single-center, self-controlled, clinical trial to verify the~     efficacy and safety of K-Rod dynamic stability system in the repair of lumbar degenerative~     diseases following 2 years follow-up, aiming to provide references for clinical treatment of~     lumbar degenerative diseases.~   "
26967|NCT03214003|"~     This trial is a multicenter, perspective, non-blinded, randomized controlled phase 3 trial.~     In order to establish whether the SIB technique can improve the results of twice-daily~     chemo-RT for patients with LS-SCLC, the investigators will primarily compare survival of~     patients treated with standard chemotherapy (cisplatin and etoposide) and either SIB~     twice-daily RT or standard dose twice-daily RT.~   "
26968|NCT03213990|"~     The purpose of this study is to find out whether continuous infusion of beta-lactam~     antibiotics or intermittent infusion or beta-lactam antibiotics, offers more health~     advantages to patients or if there is no difference.~      The investigators will be looking to see whether patients receiving beta-lactams via one~     administration method or the other have a better chance of recovering from their illness.~     They will also be looking at long term outcomes such as quality-of-life and healthcare~     resource use.~      Sepsis is caused by toxic substances (toxins) from bacteria and other organism entering the~     bloodstream from a site of infection. In some people, the infection can progress to sepsis~     and septic shock where the functions of organs in the body are affected. Patients suffering~     from sepsis and septic shock are commonly managed in the intensive care unit (ICU) where they~     are prescribed antibiotics as standard therapy, as well as other therapies to support the~     functions of the body.~      Beta-lactam antibiotics are a group of antibiotics commonly used to treat infection in~     patients with sepsis and septic shock.~      Currently, beta-lactam antibiotics are most commonly given to patients be intermittent~     infusions, that is, given at regular intervals throughout 24 hours. New research suggests~     that giving beta-lactam antibiotics as a continuous infusion may mean that antibiotic~     concentrations in the blood remain more consistent and may be more effective at killing~     bacteria.~      However, the benefit to the patient by giving beta-lactams via continuous infusion has not~     been tested in a high-quality, large clinical trial.~   "
26969|NCT03213977|"~     Patients initially are randomized into 4 arms:~      Arm I: R-DA-EPOCH; Arm II: R-DA-EPOCH + auto-SCT; Arm III: R-CEOP90; Arm IV: R-CEOP90 +~     auto-SCT.~      Patients who achieved complete remission (CR) or partial remission (PR) after 6 cycles of~     R-DA-EPOCH or R-CEOP 90, continue to have 2 more cycles for consolidation in each arm (Arm I~     and Arm III), or undergo stem cell harvest and auto-HSCT following standard institutional~     protocols. (Arm II and Arm IV).~      The overall purpose of the study is to determine if R-CEOP90 followed by auto-HSCT has~     similar efficacy compared to that with R-DA-EPOCH.~   "
26970|NCT03213964|"~     This is a Phase I trial to determine the maximum tolerated dose/maximum feasible dose~     (MTD/MFD) of a single infusion of FATE-NK100 via intra-peritoneal catheter in women with~     recurrent ovarian, fallopian tube or primary peritoneal cancer meeting one of the following~     minimal prior treatment requirement:~        -  Platinum resistant: may receive FATE-NK100 as 2nd line (as 1st salvage therapy).~          Platinum resistant is defined as disease that has responded to initial chemotherapy but~          demonstrates recurrence within a relatively short period of time (< 6 months) following~          the completion of treatment.~        -  Platinum sensitive: may receive FATE-NK100 as 3rd line therapy (as 2nd salvage therapy).~          Platinum sensitive is defined as the recurrence of active disease in a patient who has~          achieved a documented response to initial platinum-based treatment and has been off~          therapy for an extended period of time (≥ 6 months).~   "
26971|NCT03213951|"~     68Ga-PSMA is a radiopharmaceutical used with PET imaging for the detection of prostate cancer~     under a compassionate IND in patients who have presented with biochemical failure. In this~     study, the use of 68Ga-PSMA-11 will be extended to newly diagnosed patients with high risk~     prostate cancer. Patients enrolled to this study will undergo a 68Ga-PSMA-11 PET/CT or~     PET/MRI scan for research purposes (in addition to the routine CT or MRI that is routinely~     done for staging), and a second 68Ga-PSMA-11 administration just prior to surgery for~     experimental ex-vivo beta probe testing of resected tissue. Immediately following resection~     of the prostate, the intact tissue will be scanned using a PET camera designed for animal~     research in order to record the 68Ga-PSMA-11 distribution in the isolated tissue at higher~     resolution than can be attained using whole-body PET imaging. The experimental beta probe~     will then be use to measure 68Ga-PSMA-11 counts of the resected tissue.~   "
26972|NCT03213938|"~     Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) refers to the presence of~     bothersome pelvic pain symptoms without an identifiable cause. Common symptoms of CP/CPPS~     include discomfort in the perineum, suprapubic region, and lower urinary tract symptoms. It~     affects men of all ages without apparent racial predisposition, among which, 36-50 years old~     are the most commonly influenced. Yet, few effective therapies are available for treating~     CP/CPPS.~      Acupuncture may be an effective treatment option for CP/CPPS. However, effects of acupuncture~     on CP/CPPS remain uncertain because of the small sample sizes or other methodological~     limitations.~      The objective of this multi-centre, randomized, sham acupuncture-controlled trial is to~     assess the effectiveness of acupuncture for relieving symptoms of CP/CPPS. The results will~     provide a robust conclusion with a high level of evidence.~   "
26973|NCT03213925|"~     After neoadjuvant chemotherapy, patients normally receive either conservative breast surgery~     or mastectomy followed by radiation therapy. Some patients achieve a complete response after~     neoadjuvant chemotherapy. Considering that radiation therapy is an effective treatment for~     subclinical microscopic disease, the question arises whether breast surgery before radiation~     therapy can be avoided in the subgroup of patients with complete response after neoadjuvant~     chemotherapy.~   "
26974|NCT03213912|"~     The investigators determine the half maximum effective concentration (EC50) of the Cet value~     of propofol in target-controlled infusion (TCI) when co-administered with dexmedetomidine for~     the maintenance of general anesthesia during microelectrode recording in the deep brain~     surgery in patients with Parkinson's disease.~   "
26975|NCT03213899|"~     Previous studies have demonstrated the direct associations between malnutrition and hospital~     mortality as well as the length of stay in critically ill patients. However, the validity of~     these results may be limited by inappropriate diagnoses of malnutrition, small sample size,~     possible treatment bias, and sub-optimal statistical adjustment. This study aimed to further~     examine the aforementioned associations by addressing these limitations.~   "
26976|NCT03213886|"~     This study will be done to evaluate the effect of load dose of vitamin D compared to the dose~     of usual clinical practice, in improving mobility and reducing disability in older people~     following a hip fracture.~   "
26977|NCT03213873|"~     This project aims to determine the effects of the HiBalance program on neuroplastic changes~     in people with mild to moderate Parkinson´s disease. The main hypothesis is that highly~     challenging exercise will lead to greater gait and balance ability, increased levels of~     physical activity and an improved health related quality of life. The investigators further~     hypothesize that neuroplasticity changes will be seen in corresponding areas of the brain,~     neuropsychological changes on cognitive test measures, and that exercise will inhibit the~     degeneration of dopaminergic neurons in the brain through the mediation of neurotrophic~     factors.~   "
26978|NCT03213860|"~     Environmental factors such as noise and light have been cited as important causes of sleep~     deprivation in Intensive care unit (ICU) patients. Previous studies demonstrated a~     hyperalgesic alteration in pain perception following a controlled sleep deprivation protocol.~     Another studies indicated that using eye masks can improve REM sleep in healthy subjects in~     simulated ICU environment, and improve sleep quality in ICU patients. This study aimed to~     determine the effects of using eye masks on sleep and thus on pain quality in postoperative~     cardiac surgery patients in ICU.~   "
26979|NCT03213847|"~     The aim of the study was to determine whether there is a correlation between the increased~     intraneural flow as measured using Doppler ultrasound (US) and superb microvascular imaging~     (SMI) methods and the severity of CTS as measured by nerve conduction studies. Moreover,~     investigators investigated the association of increased intraneural flow with the cross~     sectional area of the median nerve. The null hypothesis that there is no correlation between~     increased intraneural flow and the severity of carpal tunnel syndrome.~   "
26980|NCT03213834|"~     The purpose of this prospective randomized clinical trial is to compare two currently~     accepted standard-of-care treatment strategies: medical thoracoscopy as compared to~     instillation of intrapleural tissue plasminogen activator (TPA) and human recombinant~     deoxyribonuclease (DNase) for the management of complicated pleural infections in adults as~     defined as complicated parapneumonic effusions or pleural empyema.~   "
26981|NCT03213821|"~     Effect of high calorie high protein diet versus high calorie,glomerular filtration rate (GFR)~     based protein intake in non-obese advanced HF patients will be assessed. In this regard,~     protein intake impact will be measured on muscle mass, physical performance and renal~     function as main outcome. Rehospitalization, quality of life, depression an inflammatory~     status are second endpoints.~   "
26982|NCT03213808|"~     Allergic diseases, including allergic asthma, allergic rhinitis and anaphylaxis are not~     properly classified in current classifications of diseases. We here propose a project based~     on the evaluation of medical records of hospital databases of patients suffering for allergic~     and hypersensitivity conditions coded with the current and a new coming version of the~     international classification of diseases, no patient or intervention will be analysed.~      We here propose a study to update and reach quality assurance of the classification of~     allergic and hypersensitivity conditions in international classification systems. The~     Allergic and hypersensitivity conditions section has indeed been recently built into the new~     ICD-11 framework and we aim to reach its quality assurance by evaluating medical records of~     French hospital databases. All the consecutive cases related to allergic and hypersensitivity~     conditions registered in the last 1 year will be selected and blind-coded by two independent~     coders based on the online English versions of the ICD-10 (2015 version) and ICD-11 Beta~     draft. The generated data will support the intra and inter-variability testing, survey among~     end-users and economic-impact evaluation. The economic impact of the transition from ICD-10~     to ICD-11 will be analysed based on average estimated cost per day of each principal~     diagnosis and the effect of the classification change will be quantified by the cost variance~     of inter or intra diagnosis of ICD-10 and ICD-11. For the bridge procedure based on the~     alignment of the allergic and hypersensitivity conditions described into the ICD-10 (and~     ICD-10 CM US adaptation) framework to the ICD-11 beta phase, we propose the mapping and~     cross-linking terms methods. Meanwhile, we will start updating the allergic and~     hypersensitivity procedures by influencing the International Classification of Health~     Intervention (ICHI).~   "
26983|NCT03213795|"~     Since the development of multibranched endografts a novel therapeutic option for the~     management of thoracoabdominal and para-renal aortic aneurysms was made accessible. The~     introduction of readily available off-the-shelf devices expanded the application of such~     technology also to those patients who could not afford to wait for a customized endograft to~     be designed and manufactured according to their aneurysm morphology~   "
26984|NCT03213782|"~     Effect of nature based sounds' intervention on Agitation and Anxiety of patients admitted in~     Intensive Care Units of MMIMS&R Hospital, Mullana, Ambala~   "
26985|NCT03213769|"~     Recurrent oral aphthous ulcer is the most common oral lesion in occurrence and one of cause~     is oxidative stress so investigators need to use antioxidant drugs like topical coenzyme Q10~     gel to treat the lesion and more safe for the participants.~   "
26986|NCT03213756|"~     A good vascular access (VA) is vital for hemodialysis (HD) patients. The start of HD with~     autologous arteriovenous fistula (AVF) means higher survival, lower sanitary costs and~     complications. The distal forearm AVF is known as the best option but not all patients are~     good candidates for this surgery, and there is a primary failure rate between 20 and 50%~     published in literature.~      The choice of the optimal AVF for each patient is conditioned mainly by the anatomical and~     hemodynamic characteristics of the artery and the vein chosen to perform the anastomosis.~     These characteristics can be modified by performing physical exercise Some vascular access~     guidelines suggest the performance of isometric exercises in the pre and postoperative period~     of the AVF confection. However, there is very little data in literature on the possible~     efficacy of preoperative exercise, although small published observational studies point to an~     improvement in the venous and arterial caliber. Regarding the postoperative exercises, they~     do seem to improve maturation, however the degree of evidence in literature is low and there~     is no consensus on the exercise protocol to follow.~      We present an open-label, multicenter, prospective, controlled and randomized study in order~     to evaluate the usefulness of preoperative isometric exercise (PIE) in pre-dialysis patients~     or in prevalent HD with indication of performing a new AVF. The randomization will be 1: 1,~     one group of patients will perform PIE for 8 weeks and the other group of patients will be a~     control group. The main purpose will be to evaluate if there is a lower rate of primary~     failure in the PIE group compared with control group.~   "
26987|NCT03213743|"~     The purpose of the study is to find out the differential expression profiling of microRNA~     before and after adiministration of dexmedetomidine in patients undergoing procedures, and~     then investigators will do some in vitro studies to validate the functions of the microRNA.~   "
26988|NCT03213730|"~     This study is part of a larger, multi-centered project done with the collaboration of~     University Of Victoria. This study holds three separate studies on the mild traumatic brain~     injured population and the use of perceptual-cognitive training (3D-MOT).~   "
28230|NCT03197467|"~     NEOMUN is designed as an open-label, single arm, prospective, monocenter, phase II study of~     pembrolizumab in a neoadjuvant setting in patients with non-small cell lung cancer of Stage~     II/IIIA suitable for curative intent surgery.~   "
26989|NCT03213717|"~     Title: Effect of body weight loading on urinary electrolyte excretion~      Swedish Title: Effekt av belastning på utsöndring av elektrolyter~      Study period: Q2-Q3 2017~      Study site: The study will be performed at the Institution for Neurology and Physiology,~     Sahlgrenska Academy, University of Gothenburg. Principal Investigator is John-Olov Jansson,~     MD, PhD, Professor at Institute of Neuroscience and Physiology, University of Gothenburg~      Background and study design: Weight reduction can be obtained by decreased appetite or~     increased metabolism. However, acute weight loss can also be obtained by loss of fluids - for~     example by increased urinary loss of fluid and salts, so called elctrolytes. Preliminary~     results from a laboratory lesson for the Master of Science in Medicine program at University~     of Gothenburg suggest that carrying a 10 kg weight vest could increase urinary excretion of~     Na+, K+ and Cl-. The purpose of this study is to investigate this further in a more~     controlled research setting. If confirmed, the results could potentially contribute to the~     development of potent diuretics or obesity medicines.~      The study will include 15 healthy volunteers and consist of three study days with about one~     week between each study day. The study subjects will go through a different study procedure~     each study day, and a randomized cross-over study design will be used to determine which~     procedure each day.~      Procedure 1: Wearing a weight vest with 10 % of body weight standing for seven hours. The~     study subject is allowed to sit for 10 minutes each hour. The reason for this is that it has~     been considered that the effect may be transmitted by weight loading of the lower~     extremities.~      Procedure 2: Wearing a weight vest with 1 % of body weight standing for seven hours, as a~     control for procedure 1, with lower loading. The study subject is allowed to sit for 10~     minutes each hour.~      Procedure 3: Wearing a weight vest with 1 % of body weight sitting for seven hours. This is a~     procedure with even less loading of the lower extremities than during procedure 2.~      Urine- and blood samples, as well as heart rate and blood pressure measurements, will be~     collected during the study days and analyzed in order to address the primary and secondary~     objectives of the study.~   "
26990|NCT03213704|"~     This phase II Pediatric MATCH trial studies how well larotrectinib works in treating patients~     with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with NTRK fusions that have~     spread to other places in the body and have come back or do not respond to treatment.~     Larotrectinib may stop the growth of cancer cells by blocking some of the enzymes needed for~     cell growth.~   "
26991|NCT03213691|"~     This phase II Pediatric MATCH trial studies how well selumetinib works in treating patients~     with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with MAPK pathway~     activation mutations that have spread to other places in the body and have come back or do~     not respond to treatment. Selumetinib may stop the growth of cancer cells by blocking some of~     the enzymes needed for cell growth.~   "
26992|NCT03213678|"~     This phase II Pediatric MATCH trial studies how well PI3K/mTOR inhibitor LY3023414 works in~     treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with TSC~     or PI3K/MTOR mutations that have spread to other places in the body and have come back or do~     not respond to treatment. PI3K/mTOR inhibitor LY3023414 may stop the growth of cancer cells~     by blocking some of the enzymes needed for cell growth.~   "
26993|NCT03213665|"~     This phase II Pediatric MATCH trial studies how well tazemetostat works in treating patients~     with solid tumors, non-hodgkin lymphoma, or histiocytic disorders that have spread to other~     places in the body and have come back or do not respond to treatment and have EZH2, SMARCB1,~     or SMARCA4 gene mutations. Tazemetostat may stop the growth of tumor cells by blocking some~     of the enzymes needed for cell growth.~   "
26994|NCT03213652|"~     This phase II Pediatric MATCH trial studies how well ensartinib works in treating patients~     with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with ALK or ROS1 genomic~     alterations that have come back or do not respond to treatment and have spread to other~     places in the body. Ensartinib may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth.~   "
26995|NCT03213639|"~     Pre-eclampsia is one of the most serious complications of pregnancy affecting 3-8 % of~     pregnancies worldwide. It is a multi-system disorder involving maternal vessels (causing~     hypertension and endothelial dysfunction), the kidneys, the liver, the lungs, the~     hematological system, the cardiovascular system and the feto-placental unit. In its most~     severe form, it affects the brain, causing seizures (eclampsia), cerebro-vascular events and~     even death.~   "
26996|NCT03213626|"~     This is an open-label, single arm, phase II trial. Safety will be monitored on an ongoing~     basis. Laboratory testing (chemistry, hematology tests) will be performed every 2 weeks for~     the first 8 weeks followed by assessments every 4 weeks. Other safety evaluations including~     EKGs, urinalysis, coagulation and thyroid function studies will be performed at regular~     intervals.~      Adverse event seriousness, severity grade, and relationship to study treatment will be~     assessed by the investigator. Severity grade will be defined by the National Cancer Institute~     (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.~      Tumors will be assessed by contrast enhanced CT or MRI every 8 weeks. Pre-treatment tissue~     will be obtained via CT-guided FNA biopsy or collected during resection. However, archival~     tissue will also be requested, when available and if adequate for testing. Post-treatment~     tissue will be obtained on Day 15 (i.e., Week 3/Day 1) via CT-guided FNA biopsy. All tumor~     tissue from eligible patients will be utilized for the correlative studies which are outlined~     in this trial.~      Each subject's course will consist of three periods:~        -  A Pre-Treatment Period in which subjects are consented and undergo screening assessments~          to be qualified for the study;~        -  A Treatment Period in which subjects receive study treatment and undergo study~          assessments. Patients who meet the eligibility criteria will be treated with~          cabozantinib orally at 40 mg daily and erlotinib orally at 100 mg daily without breaks;~        -  A Post-Treatment Period in which subjects no longer receive study treatment but undergo~          follow-up study assessments and contacts.~   "
26997|NCT03213613|"~     This project will evaluate the neuro-cognitive outcomes of a novel, adaptive attention~     training in a healthy adolescent population.~   "
26998|NCT03213600|"~     Social cognition concerns the understanding of how people think about others and how that, in~     turn, influences our behavior, feelings, and social interactions. schizophrenia~     social-cognitive impairment is profound (effect size D>1.2), medication resistant and~     critically limits functional well-being . Social cognition involves complex patterns of~     coordinated activity within numerous cortical and subcortical networks, making it a difficult~     target for clinical neuroscience investigation. Yet, prior research demonstrates that~     sensory-perceptual dysfunction in schizophrenia can upwardly generalize into higher-order~     social-cognitive impairment making perception a tractable and fruitful approach for studying~     social cognition in schizophrenia. Here, the investigators explore how distortions in~     perception of temporal coincidence can contribute to the aberrant inferences of physical~     causation and social agency.~   "
26999|NCT03213587|"~     To evaluate the efficacy and safety of apatinib in treating patients with recurrent or~     metastatic nasopharyngeal carcinoma who failed prior platinum based chemotherapy~   "
28278|NCT03196843|"~     The purpose of this study is to evaluate the efficacy of radiotherapy combine with~     raltitrexed in older patients with head and neck squamous cell carcinoma.~   "
27000|NCT03213574|"~     Robot assisted urological procedures are often long surgical cases that can potentially~     result in complicated postoperative hospital course. The amount of intravenous (IV) fluids~     administered to patients during these operations fluctuates based on the length of the case,~     surgical blood loss, hemodynamic monitors, and the discretion of the anesthesiologist. The~     goal of intraoperative fluid therapy is to maintain optimal tissue perfusion without causing~     fluid overload. We plan to use a goal directed fluid therapy protocol to optimize fluid~     status and analyze post-operative outcomes.~   "
27001|NCT03213561|"~     People with locked-in syndrome cannot move their limbs or talk because of a motor impairment,~     but remain conscious and intellectually awake. Restoring the ability to communicate to people~     with locked-in syndrome will have a positive effect on their quality of life, will enable~     them to reintegrate into society and increase their capacity to lead productive and~     fulfilling lives. This study sims to develop a new assisted communication device based on a~     brain-computer interface, a system that allows the user to control a computer with his brain~     activity. The investigators will develop this brain-computer system for long-term stability~     and independent use by using adaptive decoders. The investigators will test the long-term~     stability and independence of this system with healthy volunteers, people with tetraplegia~     and people with locked-in syndrome over time periods of several months.~   "
27002|NCT03213548|"~     Rhinoplasty is among the most accomplished aesthetic procedures in Plastic Surgery. The~     mastery of Alar Base modifications is essential for superior aesthetic results. The main~     indication is to reduce nasal width when it exceeds the intercanthal distance in Caucasian~     women. Other indications are the modification of the shape of the nostrils or to reduce alar~     flare in noses with too convex alar base. Since Wier's first description, a series of~     techniques has been developed with a common goal of making the basal view of the nose close~     to an equilateral triangle. The location and amount of tissue to be removed will be according~     to the preoperative or intraoperative indication due to changes in the alar base resulting~     from reductions in the projection of the nasal tip. One of the controversies in the~     literature is in the position of the incision in alar base modifications. Some authors~     prioritize incisions that do not violate the alar facial groove , since the groove region~     presents a greater number of sebaceous glands, leading to poor scarring results. Other~     authors have argued that incisions above the sulcus have caused more evident scars, anda that~     poor healing results would be more associated with aggressive resections of border and bad~     closing skin techniques.~      Due to divergence in the literature, the present study aims to compare, through a double~     blinded randomized clinical trial, two techniques of alar base modifications that will~     differentiate only by violating or not the alar facial groove.~   "
27003|NCT03213535|"~     This study aims to investigate the relation between the concentration of urea and creatinine~     in vaginal fluid and length of latency period in women with PROM between 32 and 35 weeks~     gestation.~   "
27004|NCT03213522|"~     The purpose of this study is to determine the efficacy of CST for the treatment of LUTS in~     patients with MS and evaluate the acute effects compared to PFPT.~      A. Objectives To examine the effect of CST as compared to PFPT on QOL, SEMG resting~     biofeedback readings, and PVR ultrasonography measures in patients with MS and LUTS.~      B. Hypotheses / Research Question(s) It is hypothesized that patients who receive CST will~     demonstrate improved QOL, bladder control and ability to empty bladder as compared to those~     who receive PFPT.~   "
27005|NCT03213509|"~     The purpose of this study is to conduct Verbal Autopsies of deaths ( stillbirths and neonatal~     deaths together) identified in the BetterBirth trial to identify their potential causes,~     timing, and social determinants.~   "
27006|NCT03213496|"~     Primary Determine the impact of prescribing a routine pre-surgical walk scheduled compared to~     conventional intervention (not recommended exercise) in reducing the length of hospital stay~     and the time of onset of ambulation during postoperative hospitalization, in patients with~     ability to move, ≥30 years who will undergo non-cardiac surgery.~      Secondary~        1. Evaluate ischemic cardiovascular events (AMI), stroke (CVA) and cardiac mortality during~          hospitalization.~        2. Evaluate the incidence of falls during hospitalization.~      Methodology The PAMP project phase II, as a component of CARDIECOL program will be~     implemented by designing a pilot study, a randomized controlled trial. Adult-patients with~     greater than or equal to 30 years old entering elective non-cardiac surgery, prior informed~     consent will be randomized to an intervention prescribed of walking in the period of 2-3~     weeks before surgery or will be assigned to a Control group/conventional care. The study was~     not blinded to patients, but evaluation and analysis of the data will be blinded for~     researchers and statisticians. Patients will be evaluated on their previous level of physical~     activity and will be evaluated by a physiatrist doctor for prescribing the walk (exercise).~     This study will include a sample of 500 patients, with capacity to mobilize, ability to walk~     at least 30 min/by day (150 min by week) for at least 1 week before surgery. Patients have to~     be hospitalized for at least 24 hours after the surgical procedure. Outcomes are length of~     stay, and time to first walk. Other results are evaluation falls during hospitalization and~     the presence of falls, report of cardiovascular events, and death by group.~      Expected results~   "
27007|NCT03213483|"~     The aim of this study will be to clinically assess the soft tissue augmentation achieved by~     the de-epithelialized free gingival graft with coronally advanced flap versus the~     subepithelial connective tissue graft with coronally advanced flap as root coverage~     procedures for management of patients with Miller class I and II gingival recession.~   "
27016|NCT03213366|"~     The purpose of this study is to test the feasibility, acceptability, and preliminary efficacy~     of E-PrEP on reaching young men of color who have sex with men (YMCSM) at high-risk of HIV~     infection to reduce HIV acquisition. E-PrEP is a peer-designed social media-based health~     intervention to increase PrEP awareness, knowledge, and motivation as a tool for HIV~     prevention and to increase linkage to primary care.~   "
27017|NCT03213353|"~     This is a single-dose, randomized, two-period cross-over study with 72 healthy male and~     female volunteers. The investigational products will be given (after fasting overnight) at~     separate visits separated by 7 ± 3 days. Blood for pharmacokinetic analyses will be drawn~     pre-dose and at 5, 10, 15, 20, 25, 30, 40, 60, 75, 90, 105 minutes, as well as 2, 2.25, 3, 4,~     5, 6, 8, and 12 hours after drug administration. Subjects will also be monitored to capture~     any adverse events that may occur. Bioequivalence will be assessed based on the single-dose~     pharmacokinetics of paracetamol, guaifenesin and phenylephrine, respectively~   "
27008|NCT03213470|"~     Intracranial artery disease has been more detected with development of HR-MR. HR-MR can~     depict vascular wall directly and give us more information beyond the pre-existing imaging~     modalities such as digital subtraction angiography, magnetic resonance angiography, computed~     tomography angiography. Hence, HR-MR is considered to become promising imaging modality for~     intracranial artery disease and many studies have been published recently. However, there was~     not enough to differentiate various intracranial artery disease such as atherosclerosis,~     dissection, moyamoya disease, vasculitis, reversible vasoconstriction syndrome. In real~     clinical arena, intracranial artery disease is too difficult to diagnose and distinguish~     among the disease. Of the disease, usefulness of HR-MR has been consistently published in the~     detection and diagnosis of intracranial artery dissection recently. HR-MR seems to be the~     most important and reliable imaging method in intracranial artery dissection as of now.~     Therefore, intracranial artery dissection is necessary to study using HR-MR. Intracranial~     artery dissection is dynamic vascular pathology. The geometric change is the most common~     among intracranial artery disease. However, there was no report about the geometric change in~     HR-MR. We acquired retrospective data about the natural course of intracranial artery~     dissection in HR-MR and are preparing for publishing an article. However, the data is not~     prospective and not intraindividual comparison. Therefore, reliability is not enough to~     convince the natural course. If we got prospective and intraindividual data, definite natural~     course of intracranial artery dissection could be acquired and would be helpful to diagnose~     the dissection and differentiate from other vascular pathologies. I'm sure that the~     longitudinal information from this study could guide us as the important map on the confusing~     HR-MR findings. In addition, our retrospective study can be a stepping-stone to perform a~     prospective study, which can increase the success rate of the prospective study. The~     protocols for imaging follow-up are as followed: initial (optional), 1 month, 3 month, 6~     month (optional), 12 month~   "
27009|NCT03213457|"~     The objective of this study is to evaluate safety and efficacy of elagolix in the management~     of moderate to severe endometriosis-associated pain in adult premenopausal female subjects~     including the safety and efficacy of elagolix in combination with concomitant hormonal~     add-back therapy.~   "
27010|NCT03213444|"~     The present study aims to investigate the impact of adjuvant chemotherapy with 5-FU isolated~     and associated with oxaliplatin in cardiac autonomic control and endothelium-dependent~     vascular function in patients undergoing colectomy for stages II and III colon cancer. Will~     be performed evaluation of cardiac and vascular function, autonomic control, functional~     capacity and blood evaluations.~   "
27011|NCT03213431|"~     This study will examine self-reported neurocognitive functioning in pediatric cancer~     survivors whose cancer therapy may have included cranial radiation, intrathecal chemotherapy,~     and high-dose intravenous antimetabolite chemotherapy. There is evidence that these therapies~     which are directed at the central nervous system (CNS) can lead to reduced volumes of~     normal-appearing white matter and neurocognitive dysfunction.~      Neurocognitive deficits can significantly impact pediatric cancer survivors' academic~     success, daily functional status, and quality of life. Previous studies demonstrate the need~     for screening and treating neurocognitive dysfunction in childhood cancer patients and~     survivors.~      This pilot study will conduct cognitive debriefing tests with childhood cancer survivors, 30~     with and 10 without neurocognitive deficits, and their parents. The collected data will aid~     in developing a comprehensive patient-reported outcomes (PRO) toolkit consisting of generic~     and specific cognitive and behavioral domains that are content-appropriate and~     interface-friendly for pediatric cancer populations.~      PRIMARY OBJECTIVE:~        -  To conduct cognitive debriefing tests with 30 pediatric cancer survivors who have global~          neurocognitive impairment (i.e., the impaired group) to understand the cognitive process~          of answering the extant pediatric PRO measures by different levels of general~          intelligence quotient (IQ). Additionally, 10 pediatric cancer survivors who have at~          least average general IQ (i.e., the unimpaired group) will be recruited for a comparison~          purpose.~      SECONDARY OBJECTIVE:~        -  To conduct semi-structured interviews with 30 parents/legal guardians of individuals who~          have global cognitive impairment as described in the primary objective in order to~          explore the general concept of their child's neurocognitive functioning, to rank the~          relative importance of different neurocognitive functioning domains, to inform a~          strategy for communicating with children and adolescents with impaired neurocognitive~          functioning for PRO research, and to suggest a user-friendly interface to collect PRO~          data from cognitively impaired children and adolescents. Additionally, 10 parents/legal~          guardians of individuals at least average general IQ will be recruited for comparison.~   "
27012|NCT03213418|"~     This project aims to develop electroretinogram as a new putative marker for dopamine release,~     and as a predictor of treatment response among patients seeking treatment for smoking~     cessation. Tobacco smoking continues to be a major public health challenge. Dopamine is a~     neurotransmitter released in the brain. Several lines of evidence suggest that dopamine~     release deficit in the brain is involved in the development and maintenance of nicotine~     dependence. The investigators hypothesize that smokers who do not have a deficit in dopamine~     release will more readily respond to behavioral treatment for smoking cessation, and in~     particular, financial incentives contingent on abstinence (Contingency Management). Previous~     pilot data suggest electroretinogram (ERG), which records electrical signals from the retina~     in response to light, is a clinically accessible correlate to dopamine release in the brain.~     The project proposes an ERG-based biomarker, and a pilot clinical trial to apply this~     biomarker to personalize smoking cessation treatment. This clinically tractable biomarker of~     central dopamine release may have a large number of future applications in the diagnosis and~     treatment of other mental illnesses and substance use disorders.~      The study will recruit normal controls and smokers, measure ERG before and after a standard~     dose of oral immediate release methylphenidate. Smokers will undergo a 12-week standardized~     treatment course of CM. The investigators will test whether smoking status and the response~     to CM are correlated to changes in ERG in response to methylphenidate challenge.~   "
27013|NCT03213405|"~     Human respiratory syncytial virus (hRSV) is the main cause of lower respiratory tract~     infection in children under one year of age. This study will evaluate the safety,~     tolerability and immunogenicity of a recombinant Mycobacterium bovis BCG vaccine that~     expresses the human Respiratory Syncytial Virus Nucleoprotein (N), in adult males (18 to 50~     years of age).~   "
27014|NCT03213392|"~     General anesthetic induced neurotoxicity has received considerable attention in the past~     decade from various pre-clinical studies in rodents and non-human primates. Which~     demonstrated that exposure to general anesthetic agents for a longer duration can induce~     neuronal cell death that can lead to adverse neurodevelopmental outcomes.~      The neuroapoptosis and impairment of neurodevelopmental processes has been postulated as the~     underlying mechanism, but the molecular mechanisms was not completely understood. Various~     hypothesis has been proposed they are- Antagonistic effect on N-methyl-D-aspartate receptors~     and agonistic effect on gamma-aminobutyric acid type A receptors; mitochondrial perturbations~     and activation of reactive oxygen species and dysregulation of intracellular calcium~     homeostasis. They trigger neuroapoptosis and cell death through the activation of caspases.3~     Caspases, a group of cysteine proteases, plays an important role in regulation and execution~     of apoptosis. Caspase-3 is most important since it is activated by many cell death signals~     and cleaves a variety of important cellular proteins.4 Various anesthetic agents like~     isoflurane, halothane, sevoflurane, nitrous oxide and propofol causes neurotoxicity by~     activation of caspase-3. Which has been proven from various animal studies western blot~     analysis, immunohistochemical analysis and flow cytometric analysis.3, 5-9 Though it is~     documented that exposure to general anesthetics causes neurotoxicity during active brain~     growth in animals, there is no evidence of such effects in adult humans.10 and it is~     difficult to separate the effects of anesthetics from surgical impact and other factors~     associated with diseases.11 The patients with aneurysmal subarachnoid hemorrhage (SAH) have~     variable degree of neurological insults and it is possible, based on the evidence from animal~     models that administration of general anesthetics could add to the neuronal insults.~   "
27015|NCT03213379|"~     The goal of the study is to compare the impact of different actigraphy procedures on the~     healthcare organization of Parkinson's disease (PK) patients using an apomorphine pump. To do~     so, the study design includes a patients' randomisation in two groups that will be followed~     during 6 months.~   "
27018|NCT03213340|"~     This is a random order cross over design trial to evaluate the efficacy of select nutritional~     ingredients on enhancing muscle perfusion in response to an acute meal stimulus.~   "
27019|NCT03213327|"~     The validity and the sensitivity of different measures implemented in the web application~     StayOk are investigated. The measures are used primarily for the assessment and the early~     identification of psychosocial risks. Secondarily, the results of the assessment are applied~     to generate health-promoting advices for the user of the web application.~   "
27020|NCT03213314|"~     This observational clinical cohort study aims to evaluate the clinical utility of~     LiverMultiScan in quantifying liver health prior to liver resection or TACE. The results will~     enable further developments in scanning protocols and software, and clearly define the~     relevance of applying this technology as part of the pre-operative assessment of the patient~     being considered for liver resection or TACE.~   "
27021|NCT03213301|"~     Aim of this study is to provide the proof of concept of efficacy and tolerability of~     lurbinectedin monotherapy in progressive malignant mesotheliomas.~   "
27022|NCT03213288|"~     The primary aim of this study is to directly compare the two major types of anthocyanins~     found in the diet (cyanidin-type and delphinidin-type) on lipid status in adults.~   "
27023|NCT03213275|"~     Recent advances in neonatal intensive care have dramatically increased the survival rate of~     extremely premature infants but the number of survivors with severe morbidity and lifelong~     neurodevelopmental impairment remains high. Perinatal white matter injury is the predominant~     form of brain injury in premature infants, often leading to adverse neurodevelopmental~     outcome. Intrauterine and neonatal infection and inflammation have been identified as major~     risk factors of neonatal brain injury. The fragile gut microbiome of premature infants seems~     to play an important role in health and disease as distortions of the microbiome occur prior~     to sepsis and necrotizing enterocolitis. Furthermore, the close link of the gut microbiome to~     neurological and psychiatric diseases in animal models suggests that the microbiome may~     influence brain maturation and development in preterm infants. Recent studies have underlined~     the importance of regulatory T cells as well as γδ T cells in brain injury, which can be~     directly influenced by the gut microbiome. It is therefore likely that an underdeveloped or~     distorted gut microbiome affects host immune response and may be a risk factor for~     neurodevelopmental disabilities in extremely premature infants who are already challenged by~     the unphysiologic early extrauterine environment after premature birth which affects~     maturation of the gut microbiome and immune system as well as neurophysiological maturation~     alike.~      Therefore, the overarching aim of the PreMiBraIn study is to elucidate the role of the~     gut-immune-brain axis on neonatal brain injury and its impact on long-term neurodevelopmental~     outcome of extremely premature infants. The study cohort will consist of a total of 60~     extremely premature infants with a gestational age < 28 weeks and birth weight < 1000 grams.~     The investigators seek to characterize the orchestrated dynamics of the maturation of the gut~     microbiome and the subsequent impact on maturation of innate and adaptive immune mechanisms~     as well as neurophysiological maturation and neurodevelopmental outcome. Furthermore, the~     investigators will assess the value of the microbiome as a prognostic indicator for neonatal~     brain injury as well as short- and long-term neurodevelopmental outcome of extremely~     premature infants.~      This goal will be achieved by state-of-the-art techniques using 16s rRNA gene sequencing of~     the gut microbiome, holistic analysis of T cell biology using flow cytometry, whole~     transcriptome analysis and proteomics as well as neurophysiological measurements~     (amplitude-integrated EEG, near-infrared spectroscopy, visual evoked potentials) and cranial~     MRI of extremely premature infants. Short- and long-term neurological outcome will be~     investigated using Bayley Scales of Infant Development, Third Edition at one and two years~     corrected age, and Kaufmann-Assessment Battery for Children at five years of age. The~     investigators expect to find microbiome signatures that are predictive for later~     neurodevelopmental disabilities which may then be used for early screening and intervention~     and may suggest personalized therapeutic options. The prospects of precision medicine~     targeting the gut-immune-brain axis in extremely premature infants hold the opportunity to~     improve the overall outcome of these high-risk patients.~   "
27024|NCT03213262|"~     In this study, investigators wanted to investigate the effect of preoperative anxiety level~     on anesthesia preference of patient. Before surgery, patients will fill the forms of Pain~     catastrophising scale (PCS), Beck depression and Beck anxiety scale. After surgery, these~     forms will be evaluated according to the choice of anesthesia.~   "
27025|NCT03213249|"~     Breast implants, either cosmetic or reconstructive, are among the most common procedures~     performed by plastic surgeons. Bacterial infections or biofilms are implicated in the~     majority of breast implant complications including infection requiring explantation, capsular~     contracture (CC), and/or breast-implant associated anaplastic large cell lymphoma (BIA-ALCL).~     The research team, which has already extensively characterized bacterial pathogenesis in the~     urinary tract and designed non-antibiotic therapeutics to reduce the incidence of~     catheter-associated urinary tract infections (CAUTIs), and proposal will study~     bacteria-breast implant interactions and explore further the impact of the breast microbiome.~     The proposed research provides a greater understanding of which bacteria can colonize breast~     implants, their source, and how effective antibiotic pocket irrigation is at eliminating~     them, and begins to examine the mechanisms by which bacteria bind and colonize the implant~     surface. These insights will set the groundwork for developing new therapeutic agents that~     can disrupt the binding of certain bacteria to breast implants. Strategies that minimize~     problems bacteria can cause, while avoiding antibiotics, will reduce bacteria-related implant~     complications, limit antibiotic-related side effects, and reduce bacterial resistance.~   "
27026|NCT03213236|"~     Up to now, no studies are available where a comparison has been made between the accuracy of,~     on the one hand, the gold standard PSG and, on the other hand, a home monitoring sleep~     apnea-diagnostic system, consisting of a pulse oximeter, and accelerometer, a smartphone for~     snoring analysis, and a mattress for ballistocardiographic (BCG) recordings.~      The purpose of this study is twofold. On the one hand, a comparison between the predictive~     performance of an automated home monitoring system and the gold standard PSG in sleep apnea~     diagnosis will be performed. The home monitoring system consists of a pulse oximeter, an~     accelerometer, a smartphone to record ambient sound, and a mattress to record the BCG signal.~     This system will be provided by KU Leuven and Equilli, two partners that work together with~     the Sleep Laboratory at UZ Leuven and the group STADIUS of the KU Leuven in the OSA+ project.~     The system performs automated signal processing and classification in order to determine the~     presence of sleep apnea events. On the other hand, this study aims to improve the phenotyping~     of patients suffering from sleep apnea. This task will be first developed using the classical~     PSG and later an evaluation will be performed on the less obtrusive system.~   "
27027|NCT03213223|"~     EXECUTIVE SUMMARY RESEARCH QUESTION TO BE ADDRESSED BY THIS PROPOSAL What are the factors~     associated with retention-in-care of women enrolled in the eMTCT Option B+ program at eMTCT~     (elimination of mother-to-child transmission of HIV) sites with high retention-in-care~     compared to eMTCT sites with low retention in care? Hypotheses Null hypothesis H0: The~     attributable rate of low retention-in-care of women in the eMTCT program at eMTCT sites~     equals zero.~      Alternative hypothesis HA: The attributable risk of low retention-in-care of women in the~     eMTCT program at eMTCT sites is not equal to zero.~      RATIONALE FOR RESEARCH There is poor retention of women along the PMTCT (prevention of mother~     to child transmission of HIV) cascade. Retention in eMTCT refers to documented regular~     participation of the pregnant woman, confirmed HIV positive, together with her child or~     children not yet confirmed as HIV-positive, in all prescribed activities aimed at preventing~     transmission of HIV from her to the child, and scheduled or unscheduled HIV-care related~     visits, measured during or at the end of care. It results in uninterrupted supply of ART~     (antiretroviral therapy). Retention in PMTCT ranges between 10.6% and 76.5% in other~     countries. In Zimbabwe it was found to drop from 83% at second pick up of antiretroviral~     drugs to 45% at fourth pick up of antiretroviral drugs. Poor retention in PMTCT leads to poor~     health outcomes in the mother and the baby. These include increased viral load, reduced CD4~     count, reduced adherence to ART, emergency of drug resistant HIV strains, reduced quality of~     life, increased frequency of opportunistic infections, increased all-cause hospitalizations~     and death of women and children. HIV infection contributes to between 6 and 20% of maternal~     deaths. On the other hand, about 14% of all new infections are due to MTCT (mother to child~     transmission of HIV).~      Retention in care is better at some clinics and hospitals. The purpose of the study will be~     to determine the factors associated with retention-in-care of women enrolled in the eMTCT~     Option B+ program at eMTCT sites.~      The following objectives will be addressed in the study:~        1. To assess the PMTCT Option B Plus program at selected eMTCT sites.~        2. To determine the prevalence of retention among women enrolled in the eMTCT Option B+~          program at selected eMTCT sites.~        3. To determine the incidence of attrition among women enrolled in the eMTCT Option B+~          program at selected eMTCT sites.~        4. To identify factors associated with variability in levels of retention-in-care of women~          in the eMTCT Option B+ program at selected eMTCT sites.~        5. To explore the barriers and facilitators of retention among women enrolled in the eMTCT~          Option B+ program.~      METHODS The study is being done through a nested, embedded, mixed methods study with priority~     given to a prospective cohort methodology. The supplementary design is a simple descriptive~     qualitative design carried out through focus group discussions. A mixed methods design caters~     for the weaknesses in either a qualitative or a quantitative design. Hence, it is ideal in~     study of complex human issues such as retention in the PMTCT Option B Plus program.~      In the study, 462 pregnant women enrolled for PMTCT Option B Plus will be followed up for 12~     months in an open cohort. The sample size was calculated using Stata software based on a~     power of 0.8, a margin of error of 0.05, a design effect of 1.1 and a retention rate of 0.45.~     Six randomly selected eMTCT sites in Mashonaland East Province were chosen for the study.~     Retention rate at the sites since 2013 will be calculated. Three sites with lower retention~     will be considered as the exposure sites. The other 3 sites will be the unexposed sites.~     Option B Plus, a recently introduced and recommended PMTCT option, was meant to benefit~     pregnant women, in addition to their children and sexual partners. Hence, the involvement of~     women as participants. Four focus group discussions will also be done, with nursing mothers~     to ascertain the barriers and facilitators of retention in PMTCT Option B plus. Included in~     the study will be HIV positive pregnant and nursing women coming for PMTCT Option B Plus.~     Women who can communicate in English or Shona and are without psychiatric conditions will~     also be included. Emancipated minors, below 18 years of age will also be included. Excluded~     from the study will be women enrolled in PMTCT Options A or B, women with psychiatric~     conditions or those who are too ill to participate. The study was approved by The Medical~     Research Council of Zimbabwe. Signed voluntary consent is sought from participants. Data is~     being collected through questionnaires and audio-taped focus group discussions. Follow-up~     data will also be extracted from eMTCT registers at respective eMTCT sites. Data is kept in~     locked cabinets only accessible to the principal investigator and the supervisors.~   "
27028|NCT03213210|"~     Single arm study to evaluate the effectiveness of treatment approach using a new moldable~     beta-tricalcium phosphate(TCP) bone graft material and polylactide membrane in~     peri-implantitis.~   "
27029|NCT03213197|"~     The researchers hypothesize that patients and their families will be comfortable watching~     standardized CPR informational videos and that they would recommend that others watch the~     videos. Furthermore, the researchers hypothesize that patients and their families will find~     the videos helpful in their own end-of-life planning.~   "
27030|NCT03213184|"~     The environment during the prenatal period and in early life is a major contributor to the~     risk of developing childhood asthma. Birth cohort studies from single research centers have~     identified several factors that affect the risk for developing childhood asthma, including~     being exposed in early life to allergens, pollutants, viruses and bacteria, and psychosocial~     stress. Despite such advances, further progress in understanding the root causes of asthma~     have been hampered by the small size of previous studies, which makes it difficult to: 1)~     identify asthma risk factors with certainty, 2) know how environmental factors across the~     United States (U.S.) affect asthma, and 3) whether there are critical ages when pregnant~     mothers, infants and young children are particularly susceptible to these influences.~     Furthermore, different research groups tend to use different methods to study asthma, making~     it difficult to either compare or pool findings. One other challenge is that there are~     several types (i.e. phenotypes, endotypes) of childhood asthma, but these are poorly~     understood. To help overcome these challenges, investigators leading 12 asthma birth cohorts~     across the U.S. have established the Children's Respiratory Research Workgroup (CREW)~     consortium. CREW proposes to identify specific types of childhood asthma, develop an~     understanding of what early life environmental influences cause these different types of~     asthma and when, and identify targets for future efforts aimed at preventing childhood~     asthma.~   "
27031|NCT03213171|"~     This study evaluates the effects of using reception staff to prompt patients by providing a~     pamphlet and an opportunity to register in the waiting room via a mobile tablet on deceased~     organ donor registration rates.~   "
27032|NCT03213158|"~     The purpose of this research study is to find out how well ixazomib (the study drug) works to~     desensitize highly sensitized kidney transplant recipients.~   "
27033|NCT03213145|"~     This is a non-randomized, 2-part, open-label, drug-drug interaction (DDI) study to evaluate~     the effect of concomitant administration of itraconazole or rifampin on the pharmacokinetics~     and safety of EDP-305 in healthy human volunteers.~   "
27034|NCT03213132|"~     This study will compare the efficacy of an interactive internet intervention for older adults~     with insomnia called SHUTi OASIS (Sleep Healthy Using the Internet for Older Adult Sufferers~     of Insomnia and Sleeplessness) accessed at www.shutioasis.org both with and without support~     for adherence to that of a static educational website to improve sleep, health, mood, and~     overall quality of life.~   "
27035|NCT03213119|"~     The exploration of space is more effective when intrinsically rewarding elements are located~     in the visual scene. Thus, rewards could be exploited as a novel rehabilitation approach to~     various attentional disorders. The first part of the project aims to characterize these~     effects at the behavioural level. The interventional part consists then in the administration~     of Caloric Vestibular Stimulation (CVS), which by means of injection of a small quantity of~     water in the external ear activates the vestibular organs and subsequently vestibular-related~     brain areas. Among the observed brain activations, the possibility to reach cingulate areas~     appears particularly interesting because it foreshadows the possibility to further enhance~     attentional capture by rewards.~      CVS will be delivered to patients with brain lesion of the right hemisphere, engaged in~     cancellation tasks requiring the processing of targets of different nature (e.g. monetary or~     neutral). The main prediction is that CVS administration would enhance spatial exploration in~     terms of center of gravity of the cancellation and improved accuracy as a function of the~     type of target processed (e.g. its value).~   "
27036|NCT03213106|"~     Cerebellar ataxias are a group of disorders caused by cerebellar affections, for which~     currently no specific treatment is available. Some limited studies verified the effects of~     cerebellar transcranial magnetic stimulation (TMS) on ataxic symptoms, with good results. So~     far it is not known which patients could benefit. Our hypothesis is that cerebellar TMS could~     improve ataxic symptoms in some patients.~   "
27037|NCT03213093|"~     Diabetic foot ulcer (DFU) is a worldwide burden in the management of patients with diabetes.~     Peripheral neuropathy has a key role in the physiopathology of DFU. Others factors as skin~     vulnerability to plantar pressure, glycation of skin protein, articular rigidity, vascular~     component and abnormal foot plantar pressure are also important to take into account. The aim~     of the study is to assess prospectively different factors involved in DFU pathogenesis~     notably the neurovascular response to non noxious pressure.~   "
27038|NCT03213080|"~     The DISCOVER TLD study is a multicenter, prospective, single-arm study designed to record the~     clinical outcomes of the CE-marked Nuvaira™ Lung Denervation System, in a subset of its~     CE-marked approved indication. This study is being conducted in Europe.~   "
27039|NCT03213067|"~     Gastrointestinal (GI) dysmotility in patients with mitochondrial disease are increasingly~     recognized and often include dysphagia, abdominal pain, abdominal distention, bacterial~     overgrowth, constipation, and in severe cases surgery. Although the proposed pathological~     mechanisms underlying the development of GI dysmotility remain diverse, potential mechanisms~     include mitochondrial dysfunction of smooth muscle within the GI tract and visceral myopathy.~     Moreover, bacteria within the GI tract, termed 'gut microbiota' has also been identified as a~     key contributor towards GI dysmotility.~      Aim: The aim of this study is to assess the role that the gut microbiota has on clinical~     disease expression in patients with mitochondrial disease.~      Objectives: This is a feasibility study to assess:~        1. How does clinical disease severity impact upon the gut microbiota in mitochondrial~          patients compared to healthy controls.~        2. How diagnostic and therapeutic approaches for mitochondrial disease be improved.~      Methods: This is a pilot study and is part of the Newcastle Mitochondrial Research Biobank.~     Stool samples will be collected from patients with a Mitochondrial Encephalomyopathy Lactic~     Acidosis and Stroke-like episodes (MELAS) phenotype carrier of the m.3243 A>G mutation (N=20)~     from the United Kingdom Medical Research Council (MRC) Centre for Mitochondrial Disease~     Patient Cohort (RES/0211/7552, the largest cohort of mitochondrial patients in the world) and~     the mitochondrial clinic and age and gender matched healthy controls (N=20). DNA will be~     extracted from stool samples and the 16S rRNA gene (V4 region) will be sequenced. This data~     will be analysed using bioinformatics pipelines and computational biology.~      Long Term Goal: To generate novel information relating to how the gut microbiota impacts upon~     clinical disease expression. This information could then be used to build a predictive model~     designed to optimise diagnosis and therapeutic treatments. This method also holds potential~     for use as a model for ageing and diseases associated with mitochondria not working properly,~     such as diabetes, cancer and Parkinson's disease. This research has the potential to reduce~     costs to the NHS and improve patient care and their quality of life.~   "
27040|NCT03213054|"~     This is a phase 1 study to evaluate safety and tolerability of Telomelysin (OBP-301) in~     combination with radiation therapy in patient with esophageal cancer who are not applicable~     to standard therapy.~   "
27041|NCT03213041|"~     The purpose of the study is to evaluate the impact on progression-free survival (PFS) with~     the combination carboplatin - pembrolizumab in patients with CTC (circulating tumor cells)~     positive, HER2 negative metastatic breast cancer previously treated with anthracyclines and~     taxanes. Previous studies have indicated that recurrent breast cancers are more resistant to~     chemotherapy and maybe associated with a weak immune system. This study is investigating the~     use of an immune therapy drug, pembrolizumab, that has the ability to restore the capacity of~     controlling and killing cancer cells of an important component of your immune system called~     T-cells. Pembrolizumab has been found effective in other types of cancer and has already been~     approved by FDA for those indications, but the efficacy in breast cancer is still unknown. In~     this study, pembrolizumab will be combined with chemotherapy to increase the cancer cell~     killing. There is no control or placebo treatment in this study.~   "
27042|NCT03213028|"~     The goal of this pilot study is to assess both implementation outcomes (acceptability,~     feasibility and adoption) and clinical efficacy (contraceptive method uptake by women wishing~     to avoid pregnancy) using a Hybrid Type 2 study design of a family planning program being~     piloted by the Cervical Cancer Prevention Program in Gabarone, Botswana.~   "
27043|NCT03213015|"~     The aim of this study was to verify the clinical reliability of ankle dorsiflexion range of~     motion (ADROM) measurement with weight bearing (WB) using an app on the smartphone (iHand)~     and to verify if there is correlation between the limitation of the ADROM and the PFP.~   "
27044|NCT03213002|"~     The purpose of this study is to evaluate the safety and efficacy of administering the~     medication capecitabine along with temozolomide when you start your monthly regimen of oral~     temozolomide for the treatment of your newly diagnosed glioblastoma multiforme (GBM).~      Capecitabine is an oral chemotherapy that is given to patients with other types of cancer.~     The study will evaluate whether the dosage of 1500 mg/m2 of capecitabine is tolerable after~     radiation, when taken along with temozolomide. It will also try to determine if the~     medication capecitabine helps patients respond to treatment for a longer period of time~     compared to just temozolomide alone, which is the standard of care.~   "
31047|NCT03160664|"~     This trial attempts to evaluate the treatment efficacy of magnetic seizure therapy (MST) and~     its safety for bipolar mania. Half of the participants will receive MST, while the other half~     will receive electroconvulsive therapy (ECT).~   "
27045|NCT03212989|"~     This is a phase I, single-site, study to evaluate the effects of VOR and HIV-1 Antigen~     Expanded Specific T Cell Therapy (HXTC) on persistent HIV-1 Infection in HIV-infected~     individuals suppressed on cART. Twelve participants with durable viral suppression will be~     enrolled and will complete the study. All participants will receive the same treatment and if~     eligible, will be dosed with HXTC and VOR. Participants will continue their baseline cART~     regimen throughout the study.~   "
27046|NCT03212976|"~     This study is designed to evaluate the accuracy of a non-invasive method phase-contrast~     magnetic resonance imaging (MR-ICP) for assessing intracranial pressure (Phase 1).~      To perform second phase contrast imaging to evaluate the patency and flow of ventricular~     catheters after MR-ICP imaging (Phase 2).~   "
27047|NCT03212963|"~     The objective of this open-label multicentric study is to determine the adrenal suppression~     potential and the pharmacokinetic (PK) properties of halobetasol lotion (HBP) applied twice~     daily for up to two weeks in subjects aged 12 to 16 years 11 months with stable plaque~     psoriasis. Subject enrollment will continue until at least 20 subjects with both screening~     and end of study (EOS) serum cortisol data (pre- and pos-tcosyntropin stimulation) have~     completed the study without any significant protocol violations (evaluable subjects). This~     may require the enrollment of approximately 25 subjects.~   "
27048|NCT03212950|"~     A randomized, double-blinded (for insulin type), single centre, crossover design young adult~     study, on 20 subjects with type 1 diabetes (T1D), aged 18 to 25 (inclusive) years, measuring~     time in glucose values within 3.9 - 10 mmol/l (70-180 mg/dl) under supervision of DreaMed~     Glucositter using either faster-acting insulin Aspart (Fiasp®, European Medicines Agency~     number EMEA/H/C/004046) or normal acting insulin Aspart.~      Study duration will be about 3 weeks per subject, 5 month overall.~      The objectives of this clinical investigation is:~      1. to evaluate the safety and efficacy of blood glucose control using the DreaMed Glucositter~     with Fiasp® in young adults with T1D during and after unannounced afternoon physical activity~     and unannounced meals, in a controlled in-hospital environment.~      Primary endpoint is significant between-group difference (intervention Fast-CL versus control~     Regular-CL) in time within range of glucose values within 3.9 - 10 mmol/l (70-180 mg/dl)~     during the unannounced afternoon exercise and unannounced standardized meals from 15:00 till~     18:00 next day based on sensor glucose readings.~   "
27049|NCT03212937|"~     This is a single center, open-label, phase I trial with a standard 3+3 dose escalation schema~     to identify the maximum tolerated dose (MTD) of selinexor when combined with ICE. Once MTD is~     determined, there will be an expansion phase and tumor biopsies and peripheral blood will be~     taken pre and post selinexor to examine the study's biologic objectives.~   "
27050|NCT03212924|"~     Listening with a cochlear implant remains difficult and most listeners will report high~     levels of listening effort.The present study is a pilot aiming to evaluate listening effort~     for cochlear implant users. The listening effort is measured with pupillometry, by monitoring~     the variations of pupil size in response to different stimuli. The size of the pupil is known~     to increase with the listening effort. The listening effort is evaluated in two different~     situation: speech perception in quiet and speech perception in noise. The pupillometry~     measures will be compared for the two listening conditions. Moreover, the study will evaluate~     the relationship between objective (pupil dilatation) and subjective measures (auto~     evaluation) of listening effort, and between speech comprehension, cognitive abilities and~     listening effort.~   "
27051|NCT03212911|"~     The finding of isolated hepatitis B core antibody (isolated HBc) in absent of recent active~     hepatitis could cause by several scenarios, including false positive, remote infection~     without viremia, and occult infection with low viremia. Hepatitis B virus (HBV) vaccine~     booster could be a great prevention strategy for those who do not have HBV viremia. There is~     no standard consensus for management of this issue especially among HIV infected population.~     In addition, prior studies revealed that HIV-infected individuals had lower immunologic~     response to HBV vaccine than general population. This study intends to compare the immune~     response and safety of 4- versus 3-standard dose of hepatitis B virus vaccination in~     HIV-infected adults who has isolated HBc. The immunologic response will be evaluated after~     the participants receive vaccination.~   "
27052|NCT03212898|"~     The primary study goal is to explore the influence of pharmacist interventions on the~     effectiveness of warfarin treatment in a specific subpopulation.~   "
27053|NCT03212885|"~     Patients with Parkinson's Disease who undergo Deep Brain Stimulation surgery receive symptom~     relief due to electrical stimulation of the brain. The target for the stimulation, in many~     cases, is the subthalamic nucleus (STN). The brain area just above the STN is called the~     rostral Zona Incerta (rZI). The rZI may be a potential target for deep brain stimulation, in~     combination with the STN.~   "
27054|NCT03212872|"~     Assessment of blood ammonia level as a non-invasive predictor for presence of EV and risk of~     bleeding~   "
27055|NCT03212859|"~     In a previous trial, researchers demonstrated that the Coach2Move approach is superior to~     regular physiotherapy in terms of increasing physical activity, reducing frailty, improving~     quality of life and reducing healthcare costs. In short, in less physiotherapeutic sessions,~     better outcomes were realized.~      Despite these promising findings, the research group still has questions regarding the~     generalisability of these findings. The reservations towards the generalisability of the~     approach are caused by the following:~        1. A modest (n=130), yet somewhat selective study sample was included: nearly half of the~          eligible individuals declined randomisation and thereby participation. An understanding~          is needed how this group of eligible non volunteers respond to Coach2Move. Therefore, a~          study design that avoids randomisation at the patient level will be used.~        2. The Coach2Move approach significantly increased the level of moderate physical activity~          among the treatment group and reduced levels of frailty significantly after 6 months,~          but the clinical importance of these findings is still unclear. Thus, a replication of~          the effects in the light of physical functioning is needed in a larger more variable~          study population and with a longer follow-up.~      In addition, the results from the earlier carried out RCT concerning the cost-effectiveness~     of Coach2Move have to be replicated on a larger scale.~      For the reasons mentioned above, it is important to further implement Coach2Move and study~     its effect, costs, and feasibility in current practice. A stepped wedge cluster randomised~     trial design is chosen because in the opinion of the researchers, the implementation strategy~     will do more good than harm (making a parallel design, in which certain practices do not~     receive the intervention or to withdraw the intervention as would occur in a cross-over~     design, is unethical) and it furthermore minimizes contamination.~      The objective of this study is to assess the cost-effectiveness of the implementation of a~     patient and context focused tailored coaching intervention (Coach2Move) in the daily~     physiotherapy practice for older adults with mobility problems compared to usual~     physiotherapy. The hypothesis is that Coach2Move leads to better physical outcomes and lower~     costs than usual care.~   "
27056|NCT03212846|"~     The aim of this study is to evaluate if a intervention with hippotherapy will improve~     spasticity for children ages 3-14 who have cerebral palsy. The hip aductors spasticity will~     be measured using the Modified Ashworth Scale (MAS). The intervention will be performed in~     addition to traditional treatment.~   "
27057|NCT03212833|"~     Globally, approximately 170 million people are infected with hepatitis C virus (HCV); 350,000~     deaths each year are caused by HCV infection (Perz,et al, 2006).The Egyptian Demographic~     Health Survey (EDHS), across sectional survey including hepatitis C virus (HCV)biomarkers,~     was conducted in 2008 on a large nationally representative sample (El-Zanaty F, et al 2009).~     It estimated HCV prevalence among the 15-59 years age group to be 14.7% (El-Zanaty F, et al~     2009).Accordingly, Egypt has the highest HCV prevalence in the world (Lavanchy D, 2011), (~     Shepard CW,et al 2005)..Interferon (INF)-free regimens of combined directly acting antivirals~     (DAAs) have shown improved efficacy and tolerability compared with interferon~     (IFN)-containing regimens, and they have become the standard of care for treatment of HCV~     genotype-1 (HCV-1)(Afdhal, et al, 2014).Insulin resistance is a state in which a given~     concentration of insulin produces a less-than-expected biological effect. The prevalence of~     type 2 diabetes mellitus in hepatitis C in cirrhotic patients is 27.3% which is higher than~     among non-cirrhotic hepatitis C patients (17.5%)(Romero-Gómez, 2006). HCV promotes insulin~     resistance and insulin resistance induces interferon resistance, steatosis and fibrosis~     progression in a genotype-dependent manner.In HCV-1, insulin resistance decreases sustained~     response rate, and increase the risk for the development of steatosis and fibrosis~     progression, However, the impact of insulin resistance in other genotypes seems not achieve~     enough importance to impair sustained response, probably due to the high sensitivity to~     peginterferon. The treatment of insulin resistance, decreasing hyperinsulinemia, could~     improve sustained response rate in patients with chronic HCV-1 infection when treated with~     peginterferon plus ribavirin(Romero-Gómez,2006).~      Objectives: we aim to determine the prevalence of insulin resistance among the patients with~     chronic hepatitis C virus( HCV) infection and to explore the association between insulin~     resistance and therapeutic response by comparing the insulin resistance among responders and~     non-responders to oral treatment of chronic hepatitis C virus infection Patients and methods:~     The study is intended to include patients of chronic hepatitis C virus infection receiving~     oral treatment for one year period. All patients will have clinical evaluation,~     ultrasonographic examination, and laboratory investigations which include complete blood~     count, liver function tests, estimation of fasting serum glucose, fasting serum insulin, and~     determination of insulin resistance index.The patients will be selected according the~     selection criteria determined by the National Committee for Control of Viral Hepatitis~     (NCCVH).~   "
27058|NCT03212820|"~     20 patients were selected requiring implant placement and divided randomly into two groups~     (10 in each group)~        -  for the study group, starter drill is used to locate the point of insertion as planned~          then pilot drill is also used to the full desired working length after that all other~          sequential drills are used at a low speed (50-70 rpm) without irrigation .~        -  In the study group: implant will be inserted in the low speed osteotomy site.~        -  In the control group: implants will be inserted in the conventional prepared osteotomy~          site.~        -  For both groups there is no surgical guide used.~        -  The flap will then be copiously irrigated with saline in preparation for closure.~        -  The flap will then be closed using interrupted 4/0 resorbable sutures.~   "
27059|NCT03212807|"~     PHASE II STUDY OF DURVALUMAB IN COMBINATION WITH LENALIDOMIDE IN RELAPSED/REFRACTORY EBV~     ASSOCIATED SUBTYPES OF DLBCL, PRIMARY CNS LYMPHOMA AND PRIMARY TESTICULAR DLBCL~      Patients with relapsed refractory subtypes of DLBCL who fulfill the inclusion / exclusion~     criteria will be recruited to this trial and treated in this open label, phase 2 trial with~     the PDL1 inhibitor Durvalumab and Lenalidomide. The combination treatment will be given from~     the time of recruitment for 6 months when Lenalidomide will be stopped but Durvalumab will~     continue for a total of 2 years. Response will be assessed by PET / CT scans as per standard~     lugano criteria.~   "
27060|NCT03212794|"~     The purpose of this 24-week study is to evaluate the impact of recovery coach intervention on~     rates of treatment retention, illicit opioid use, and readmission among hospitalized patients~     newly initiated on buprenorphine compared to the control intervention.~   "
27061|NCT03212781|"~     Iron deficiency is the most prevalent nutritional deficiency and the most common cause of~     anemia .It is characterized by a defect in hemoglobin synthesis, resulting in red blood cells~     that are abnormally small (microcytic) and contain a decreased amount of hemoglobin~     (hypochromic).~   "
27062|NCT03212768|"~     Ankle fractures are among the most common osseous injuries to the lower extremity, and remain~     a significant source of morbidity for both the young and the elderly. Recent cross-national~     studies have shown a significant increase in the incidence and severity of ankle fractures~     among the elderly population.~   "
27063|NCT03212755|"~     Diabetes mellitus is a chronic disease that affects 366 million people worldwide ( 6.4 % of~     the adult population ) and is expected to rise to 522 million by 2030 . Diabetic nephropathy~     occurs in approximately one - third of all people with diabetes and is the leading cause of~     renal failure in developed and developing countries Diabetic nephropathy is a severe~     complication occurring in diabetic patients and it is associated with an increased risk of~     all- cause mortality , cardiovascular disease and progression to end stage renal disease ,~     requiring costly renal replacement therapy in the form of dialysis or transplantation~   "
27064|NCT03212742|"~     The Stupp protocol is the standard treatment of glioblastoma multiform (GBM) which prognosis~     remains poor.~      The non-dividing nature of normal brain cells provides an opportunity to enhance the~     therapeutic ratio by combining radiation with inhibitors of replication-specific DNA repair~     pathways such poly(ADP-ribose) polymerase (PARP) inhibitors, thus inducing more cytotoxic~     effects of DNA-damage related to treatment modalities, including alkylating reagents like~     temozolomide (TMZ).~      Olaparib, a potent PARP inhibitor, overcomes apoptotic resistance and sensitizes GBM cells~     for death receptor-mediated apoptosis induced by TRAIL (Tumor necrosis factor-Related~     Apoptosis Inducing Ligand). Moreover, inhibition of PARP activity increases cellular~     sensitivity to ionizing radiation: it was even suggested to be more pronounced in tumors than~     in normal tissue.~      Lastly, progress in technical imaging and intensity-modulated-radiotherapy (IMRT) techniques~     provide new possibilities for sparing healthy tissues.~   "
27065|NCT03212729|"~     Microorganisms play a critical role in the etiology and pathogenesis of apical periodontitis.~     Enterococcus faecalis and Candida sp. are frequently associated with persistent infections.~     The aim of this study was evaluated the antimicrobial photodynamic therapy (aPDT) as an~     adjunct of the endodontic treatment. Ten uniradicular teeth [control group (CG)=4 and test~     group (TG)=6] with primary endodontic infections were analyzed. Microbiological samples were~     collected before and after the chemical-mechanical instrumentation (CMI), after the aPDT (for~     the TG) and after the temporary restorations removal (second session).~   "
27066|NCT03212716|"~     The aim of this study is to evaluate the possibility to repropose marketed drugs as antiviral~     ones, based on their ability to reverse the transcriptomic signature of the infected cells.~     This strategy has to be considered is the context of emerging viral diseases and of increase~     of resistance to antivirals. Concerning infection by Influenza viruses, two main drugs were~     identified and evaluated on in vitro and in vivo models: etilefrine and diltiazem. Therefore,~     it will be assess the efficacy of these two drugs, compared to placebo, to treat severe flu.~   "
47428|NCT02946099|"~     Comparing the postoperative pain resulting after mechanical instrumentation using Reciproc~     reciprocating files versus that resulting after using ProTaper Next rotary files in~     asymptomatic necrotic molars.~   "
27067|NCT03212703|"~     The purpose of this study is to investigate the role of a mindfulness-based skills training~     program for parents of children with obsessive compulsive disorder (OCD). The investigators~     will explore if parents involved in this group experience any change in their levels of~     stress, feelings of being an effective parent and family relationships compared to a waiting~     list control period. The investigators will look at how the family manages OCD in their~     lives. In particular, if mindfulness skills training will help increase the parents ability~     to tolerate distress in their child secondary to OCD and as such reduce the family~     accommodation of OCD. As family accommodation is an important negative prognostic predictor~     for children with OCD, changes in OCD symptom severity and functional impact in these child~     will also be measured.~   "
27068|NCT03212690|"~     The purpose of this study is to assess whether circulating Angiotensin (Ang) II and Ang (1-7)~     levels are associated with right ventricular (RV) dysfunction in mechanically ventilated~     subjects. It is also designed to further characterize the subject population for severity of~     RV dysfunction. This study will investigate the association of renin-angiotensin system (RAS)~     peptides and markers of RV function, as measured by echocardiography, in subjects requiring~     acute mechanical ventilation. Maximum 150 subjects will be enrolled for the study and they~     will be evaluated over three days period using standard of care investigations, including~     trans-thoracic echocardiography (TTE) and/or trans-esophageal echocardiography (TOE)~     echocardiography. The maximum total duration of this study for subjects is 28 days.~   "
27069|NCT03212677|"~     Iron deficiency-related anemia is the most common nutritional deficiency disorder in the~     world, mainly affecting children, women and older adults in underdeveloped countries. To~     combat iron deficiency, inorganic forms of iron (such as ferrous sulfate) are often used as~     an iron supplement. One big problem is that high levels of this kind of iron supplement~     produce negative health effects. This includes diarrhea, changes in the bacteria in the gut,~     as well as increased severity to malaria in young children in countries with high rates of~     that parasite.~      Most forms of iron are not well absorbed and, therefore, pass through the intestine to be~     eliminated in the stool. This unabsorbed iron can be used by gut bacteria, disturbing the~     balance of healthful and potentially harmful bacteria in the colon, which can increase~     inflammation in the body.~      In this study, the investigators are seeking to determine whether two new forms of iron cause~     fewer changes in the gut bacteria thus lowering inflammation while providing similar amounts~     of iron to the body. The findings from this research study are important because they will~     inform the development of safer treatments for iron deficiency.~   "
27070|NCT03212664|"~     The primary aim was to assess whether a one-time physical therapy program for hyperkyphosis~     is effective. Participants received physical therapy exercises and were followed for 6 months~     for pain intensity, quality-of-life, and perceived spinal appearance.~   "
27071|NCT03212651|"~     monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the~     interaction between PD-1 and its ligands, PD-L1 and PD-L2; Recent phase I trial provided~     evidence of activity of pembrolizumab in advanced platinum-resistant metastatic urothelial~     carcinoma; Recent phase 3 trial showed an overall survival benefit in patients treated with~     pembrolizumab in a trial comparing pembrolizumab to chemotherapy in patients who failed~     first-line platinum-based chemotherapy Neoadjuvant chemotherapy followed by radical~     cystectomy is the standard of care for cisplatinum-eligible non-metastatic MIBC patients;~     Many patients with MIBC are unfit for cisplatin-based combination treatment; Given its safety~     profile, pembrolizumab may be used in unfit patients; Neo-adjuvant setting is a unique~     opportunity to assess mechanisms of action of pembrolizumab in human~   "
27072|NCT03212638|"~     The purposes of this study are to determine:~        -  If there are any differences in the amount of baricitinib in the blood/body when taken~          in two different forms.~        -  How a high-fat, high-calorie meal affects the amount of baricitinib in the blood/body.~        -  The safety and tolerability of baricitinib.~      The study has two parts. Individuals will participate in only one part.~      Participants will be admitted to the clinical research unit (CRU) and will be discharged from~     the CRU following the completion of 3 overnight stays.~      Each part of this study will last from 8-10 days, not including screening. Follow-up will~     occur 7 to 14 days after the last dose of baricitinib.~   "
27073|NCT03212625|"~     Many investigators have studied for prevention and care of Hand-Foot Skin Reaction(HFSR), and~     urea cream is typical representative. Recent study was performed prevention effect of urea~     cream for Hand-Foot Skin Reaction(HFSR) on 871 Chinese. But the study did not designed as~     placebo-control group and it had big defect in double-blinded.~      Therefore, it needs complementary study as double-blinded placebo-controlled trial and effect~     of urea cream on Korean patient group.~   "
27074|NCT03212612|"~     The exact cause of endometriosis is unknown ,so our study is to investigate the relationship~     between Galectin-3 and endometriosis by comparing between its level in healthy and~     endometriosis women. Also, we will measure the level of oxidative stress markers in~     endometrium of both healthy and endometriosis women and investigate the correlaton between~     them and galectin-in endometriosis women.~   "
27075|NCT03212599|"~     A causal therapeutic approach for treatment of Alzheimer's disease has not been established~     so far. The protein ADAM10 represents a promising target for an A-beta peptide preventing~     strategy. Treatment of human neuronal cells with Disulfiram, a drug which is used in clinical~     routine for recrudescence prevention of alcohol dependency, revealed an increased expression~     of ADAM10. This finding indicates a neuroprotective potential of Disulfiram. The~     investigators' research purpose aims at the verification of the results obtained in cell~     culture experiments in the human organism. Therefore, include alcohol addicted patients were~     included, which take the drug Disulfiram for recrudescence prevention, in our study. Patients~     are recruited from the patient-collective of the University Medical Center Mainz and the~     Central Institute for Mental Health Mannheim. Blood samples (max. 5 ml) are taken from the~     participants before the intake of Disulfiram and about two weeks after treatment. Demographic~     data are collected (such as age or onset of addiction). Gene expression is analyzed via~     reverse transcription polymerase chain reaction(RT-PCR) from blood cell-derived messenger~     ribonucleic acid (mRNA).~   "
27076|NCT03212586|"~     This study is a first-in-man study that will investigate the safety, tolerability and~     pharmacokinetics of ascending single doses of BAY1902607 using a placebo controlled,~     randomized, single center design. In addition the influence of food on the pharmacokinetics~     of BAY1902607 and the bioavailability between different pharmaceutical formulations will be~     investigated~   "
27078|NCT03212560|"~     Hematologic malignancies are neoplasms that affect the blood, bone marrow, and lymph nodes.~     Hematological malignancies are the most common forms of leukemia, lymphoma, and myeloma, with~     numerous subtypes. The general symptoms of leukemia are fatigue, increased susceptibility to~     infection, bleeding, and the formation of bruises easily. Typical lymphoma symptoms are night~     sweats and involuntary weight loss, recurrent fever, fatigue, and itching. Myeloma patients~     often have bone pain, fatigue, anemia, hypercalcemia or infection symptoms.~      Adverse effects of hematologic malignancies and treatments cause abnormality in physical~     function and quality of life. Treatments such as chemotherapy, radiotherapy and hematopoietic~     stem cell transplantation, which may have side effects on the body systems are used in early~     or late period. The most common side effect due to chemotherapy is fatigue. Vomiting, weight~     loss, anemia, depression, decreased aerobic capacity, loss of muscle strength, decreased~     physical functioning and deterioration in the quality of life are indirect side effects seen~     in patients.~      In the literature, side effects of hematological malignancies have been investigated after~     treatment in patients. However, no study investigated exercise capacity, quality of life,~     physical activity level and pulmonary functions on newly diagnosed hematologic malignant~     patients. Therefore, the investigators aimed to compare aforementioned outcomes in newly~     diagnosed hematologic malignant patients and healthy controls.~   "
27079|NCT03212547|"~     The objective of this project is to determine the effect of the verbal intervention on the~     decrease in sustained social withdrawal in late and moderately late preterm infants. The~     intervention will be performed by pediatricians trained in the Alarm Distress Baby Scale~     (ADBB). This scale has been applied to term and preterm newborns in multiple international~     studies, but it has not yet been applied in Chile, nor with moderately late and late preterm~     infants.~      Infants are social beings who are born with innate reciprocal communication skills that can~     be observed during the two first months after delivery in babies with normal development.~     These skills include abilities to make and maintain eye contact, to vocalize and to use~     facial expressions, body and head movements to start interactions. Micro-analytical studies~     have demonstrated the frequent appearance of short episodes of social withdrawal affecting~     the infant during mother-baby interactions, whose function is to regulate the interaction~     flow. This behavior can be perceived when the infant needs to calm down or when is tired, and~     as a reaction to transitory interaction disturbances. In contrast with these short episodes~     of social withdrawal, the occurrence of sustained social withdrawal in infants is~     significantly less and is frequently associated with pathological conditions, such as autism~     spectrum disorder, child depression, and severe or chronic pain. Additionally, sustained~     social withdrawal is a symptom of anxiety and post-traumatic stress disorders. Different~     studies have revealed a prevalence of 10-14% sustained social withdrawal in term infant~     populations and of 13-22% in pre-term infant populations. In addition, the increase in~     sustained social withdrawal has been related to deviations of the interaction skills,~     attachment, as well as to relational and behavioral disorders. The increase and~     chronification of sustained social withdrawal, used as a defensive conduct, imply a risk to~     the adequate development of an infant's potential and raise the probability of alterations in~     the development of his psychopathology.~   "
27080|NCT03212534|"~     Through the mapping of retrospective patient data into a discrete multidimensional space, a~     novel algorithm for homeostatic analysis, was built to make outcome predictions. In this~     prospective study, the ability of the algorithm to predict patient mortality and influence~     clinical outcomes, will be investigated.~   "
27081|NCT03212521|"~     A study to evaluate the efficacy and safety of glecaprevir(GLE)/pibrentasvir(PIB) in~     treatment-naïve participants with chronic hepatitis C virus (HCV) genotypes 1-6 infection and~     with an aspartate aminotransferase to platelet ratio index (APRI) of less than or equal to 1.~   "
27082|NCT03212508|"~     Continuous distending airway pressure (CPAP) has gained popularity as a means to provide~     non-invasive respiratory support in neonates to reduce ventilator induced lung injury (VILI).~     However, maintaining CPAP in preterm infants has been challenging, often related to issues~     with nasal interface such as nasal septal injury, problems with keeping the prongs in the~     nose and leak around the prongs with are important factors in proving effective CPAP. RAM~     cannula was recently approved for providing supplemental oxygen and soon adapted by many~     centers to provide CPAP in preterm infants. Concerns have been raised that RAM cannula~     interface results in sub-optimal pressure delivery compared to standard nasal prongs.~   "
27083|NCT03212495|"~     Knee arthroscopy is a minimally invasive day case procedure which may be done for diagnosis,~     meniscectomy or debridement. Arthroscopic surgery is associated with a variable degree of~     postoperative pain, which is caused by an irritation of free nerve endings of the synovial~     tissue, anterior fat pad, and joint capsule due to surgical excision and resection~   "
27084|NCT03212482|"~     Mechanical ventilation is an important support strategy for critically ill patients. It could~     improve gas exchange, reduce the work of breathing, and improve patient comfort. However,~     patient-ventilator asynchrony, which defined as a mismatch between the patient and ventilator~     may obfuscate these goals. Studies have shown that a high incidence of asynchrony (asynchrony~     index > 10%) is associated with prolonged mechanical ventilation and ICU length of stay and~     high mortality. So far, there have been only a few studies on the epidemiology of asynchrony~     in brain-injured patients. Investigators conduct a prospective observational study among~     brain-injured patients to determine the prevalence, risk factors and outcomes of~     patient-ventilator asynchrony. Esophageal pressure monitoring, a surrogate for pleural~     pressure, combined with airway pressure and flow waveforms is used to detect~     patient-ventilator asynchrony.~   "
27085|NCT03212469|"~     The study is an open label, paucicentric, Phase I/II trial aiming to evaluate the safety, the~     clinical activity and abscopal anti-tumor effects of a therapeutic strategy associating~     Durvalumab in conjunction with SBRT or Durvalumab + Tremelimumab in conjunction with SBRT in~     patients with metastatic squamous cell carcinoma of head and neck, lung, or esophagus.~   "
27099|NCT03212287|"~     To confirm the following safety topics in patients to be treated with BRILINTA tablets 60 mg~     or 90 mg (hereinafter referred to as BRILINTA) in clinical practice in the post-marketing~     phase.~        1. Profile and incidence of ADRs The CEI will be conducted to collect data of the events,~          especially focusing on bleeding, dyspnoea and bradyarrhythmia so as to investigate~          onset, outcome, treatment for the event, and risk factors for these events, etc.~        2. Profile and incidence of ADRs not expected from Precautions for Use of the ticagrelor~          JPI~        3. Efficacy: Profile and incidence of cardiovascular events (cardiovascular death,~          non-fatal myocardial infarction and non-fatal ischemic stroke)~        4. Factors which may affect safety or efficacy of ticagrelor~   "
27100|NCT03212274|"~     This phase II trial studies how well olaparib works in treating patients with glioma,~     cholangiocarcinoma, or solid tumors with IDH1 or IDH2 mutations that have spread to other~     places in the body and usually cannot be cured or controlled with treatment. Olaparib may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
27086|NCT03212456|"~     The use of opioids facilitates angiogenesis and has a proven action in the immune system,~     mainly in the reduction of natural killer cell activity, favoring the migration of neoplastic~     cells and inhibiting humoral and cellular immunity. These factors may contribute to~     recurrence and tumor metastasis.~      Therefore, could opioid-free anesthesia help reduce tumor recurrence? This is a prospective~     randomized controlled clinical trial in which patients undergoing radical prostatectomy will~     be evaluated by conventional means, which have moderate and high D'Amico criteria for tumor~     recurrence.~      In the operating room, patients will be monitored, receive peripheral venoclysis and then~     randomized into two groups: in group I, the anesthetic induction will be done with pre~     oxygenation with 100% O2, propofol, cisatracurium, lidocaine and fentanyl; In group II the~     induction will be done with the same doses of propofol, cisatracurium, lidocaine and placebo.~      In both groups maintenance of general anesthesia will be with propofol 1% target infusion~     controlled with model of Marsh target-controlled infusion plasma between 2.0 and 3.0 mcg /~     ml, ketamine, lidocaine and dexmedetomidine.~      Both groups will receive blockade of the transverse plane of the ultrasound guided~     ultrasound, group I with placebo (saline 0.9% 20 ml on each side) and group II with~     ropivacaine 0.375% 20 ml on each side. And the postoperative analgesia will be based on~     anti-inflammatory and opioid analgesics (pca of morphine) according to the analgesic pain~     scale of the patients.~      In the postoperative period, patients will be followed up for 2 years with serial doses of~     prostate specific antigen (PSA) to diagnose tumor recurrence (2 PSA measures> 0.2 ng / ml)~     and will be evaluated in relation to analgesia, need for analgesia of Rescue with morphine,~     satisfaction with the anesthetic technique, adverse effects (nausea and vomiting).~      The primary objective is to evaluate tumor biochemical recurrence after radical prostatectomy~     in patients undergoing opioid anesthesia compared to patients anesthetized without opioids.~     The secondary objectives are to evaluate the quality of analgesia with the two techniques,~     patient satisfaction with perioperative period, quality of anesthetic recovery and adverse~     effects (nausea and vomiting, pruritus and drowsiness).~      Thus, to answer the hypothesis raised, 146 patients will be needed (73 in each group).~   "
27087|NCT03212443|"~     Arthroscopic shoulder surgery is associated with severe pain postoperatively. Regional nerve~     block adding to general anesthesia might improve the quality of postoperative analgesia. The~     aim of the study is to compare the subacromial local anesthetic infiltration and the~     suprascapular-axillary nerve blocks combination for intraoperative sevoflurane consumption,~     postoperative analgesia and analgesic consumption.~   "
27088|NCT03212430|"~     To measure the cerebral hemodynamic effect of L-kynurenine.~   "
27089|NCT03212417|"~     The purpose of this study is to evaluate the impact education has on reducing compassion~     fatigue in Oncology Clinical Research Nurses.~   "
27090|NCT03212404|"~     CK-301 is a fully human monoclonal antibody of IgG1 subtype that directly binds to Programmed~     Death-Ligand 1 (PD-L1) and blocks its interactions with the Programmed Death-1 (PD-1) and~     B7.1 receptors. The primary objective of this study is to assess the safety, tolerability and~     preliminary efficacy of CK-301 when administered intravenously as a single agent to subjects~     with selected recurrent or metastatic cancers.~   "
27091|NCT03212391|"~     Monocentric unblinded two parallel-group randomized controlled trial to evaluate the effect~     of diet with or without Nordic Walking on weight loss, physical performance and~     cardiovascular risk factors in overweight and obese population~   "
27092|NCT03212378|"~     In routine clinical practice, high-risk patients with high-risk anatomies are more often~     referred for interventional treatment by percutaneous coronary interventions (PCI). Current~     guidelines only suggest that elective insertion of an appropriate hemodynamic support device~     as an adjunct to PCI may be reasonable in selected high-risk patients.~      The objective of this retrospective study is to investigate the safety and efficacy of a~     standardized program for complex high-risk interventional procedures (CHIP).~   "
27093|NCT03212365|"~     Plastic and reconstructive surgeons consistently create large, raw surfaces as part of their~     operative procedures. Thus, plastic & reconstructive surgery patients are among those at~     highest risk for anticoagulant-associated bleeding adverse drug events (ADEs). Our~     preliminary data has shown that a fixed, or one size fits all dose of enoxaparin, an~     anticoagulant, can allow a high proportion of patients to have appropriately thinned blood,~     measured by anti-Factor Xa (aFXa) levels. Patients with adequate aFXa levels are known to~     have significantly decreased venous thromboembolism risk (VTE), which is desirable. However,~     30% of patients who receive fixed dose enoxaparin have blood that is too thin. Patients who~     are over-anticoagulated are significantly more likely to have ADEs including bleeding~     requiring return to the operating room, need for blood transfusion, or death. The optimal way~     to dose enoxaparin to minimize ADEs remains unknown. This study seeks to optimize both the~     safety and effectiveness of post-operative enoxaparin by comparing aFXa levels, bleeding~     events, and VTE events among plastic & reconstructive surgery patients randomized to receive~     two different enoxaparin dose regimens.~   "
27094|NCT03212352|"~     This study aims to compare whether a combination of two drugs (Mifepristone and misoprostol)~     are superior compared to using only one of these drugs (Misoprostol) as medical treatment for~     a miscarriage. Women in whom early pregnancy failure, 6-14 weeks postmenstrual, is~     ultrasonographically confirmed qualify for this study.~      It is expected that the combination of Mifepristone and Misoprostol is more effective in~     reaching complete evacuation, and therefore can prevent more invasive treatment such as~     curettage.~   "
27095|NCT03212339|"~     This study will examine the efficacy of a dyadic therapy intervention for mothers who have~     histories of adverse events (e.g., history of family violence, partner violence, family~     conflict, and/or childhood trauma, including abuse/neglect) and their very young children~     (ages 0-5 years), with the goal of demonstrating how an evidence supported, community-based~     and/or hospital-based therapeutic intervention may help reduce exposure to trauma and~     incidents of child maltreatment, improve parental stress and mental health, and secure~     parent-child attachment.~      The three main objectives associated with Project BELONG are: 1) to determine the~     effectiveness of a dyadic care model in improving parent/child interaction, parenting~     confidence and competence, reducing parenting stress and social isolation, and improving~     access to concrete supports; 2) to address maltreatment risk in children by enhancing~     social-emotional functioning and developmental progress; and 3) to train new and future~     mental health professionals in dyadic mental health services and disseminate the model and~     findings through health professional schools and publications.~   "
27096|NCT03212326|"~     There is a high correlation between scar areas identified by contrast-enhanced ICE and scar~     areas identified by conventional electroanatomic mapping. Therefore, the investigators will~     assess the utility of contrast-enhanced ICE to identify and localize myocardial scar~     real-time during VT ablation procedures.~   "
27097|NCT03212313|"~     This is a two-part, open label, single-dose study that will evaluate the PK of tozadenant in~     subjects with different degrees of hepatic impairment to the PK of a single-dose of~     tozadenant in healthy subjects.~   "
27101|NCT03212261|"~     The Relaxation Response Resiliency Program (3RP) was developed by researchers at the MGH~     Benson-Henry Institute for Mind Body Medicine; This program has recently been adapted to~     target the needs of individuals who have completed treatment for lymphoma (3RP-Lymphoma).~   "
27102|NCT03212248|"~     This preliminary study investigates in patients with possible clinical diagnosis of~     pneumonia, clues and biomarker assessed at Emergency Department (ED) triage, potentially~     predicting detection of lung consolidation by Thoracic-ultrasound (TUS) and/or by~     Chest-X-Rays. Cough and high admission CRP levels will be defined according to the cutoff~     defined by ROC analysis, will be challenged if independently associated with TUS lung~     consolidation detection High level of the chosen biomarker, and any of the considered~     symptoms, in otherwise not extremely critical patients (CURB65≤3), should prompt to immediate~     confirm by TUS, during the physical examination. This may limit the need of further~     radiological investigations allowing targeted workup.~   "
27103|NCT03212235|"~     Notwithstanding major improvements in treatment modalities, the prognosis of patients with~     glioblastoma is poor. Hypofractionated radiation therapy as an alternative of the standard~     6-week regimen could be an attractive approach as an effort to prevent tumor cell~     repopulation and reduction the total treatment period promoting patient comfort and~     convenience.~   "
27104|NCT03212222|"~     The purpose of this study is to evaluate how visual acuity assessed with Peek Acuity (a cell~     phone application to check visual acuity) among preschool and school-aged children 3 to less~     than18 years of age (1) compares to the standard visual acuity exam in the ophthalmology~     clinic and (2) performs as a screening test for ocular abnormalities that warrant referral~     for an eye exam.~   "
27105|NCT03212209|"~     This is a crossover study comparing the effect of CPAP Fixed Pressure, CPAP FLEX -PLUS and~     Sensawake on sleep quality, adherence to treatments, and PSG parameters in patients with~     moderate to severe OSA.~   "
27106|NCT03212196|"~     This trial will investigate what surgical technique between pancreaticogastrostomy and~     pancreaticojejunostomy with transanastomotic externalized drains is associated with the~     lowest rate of pancreatic fistula after pancreaticoduodenectomy in case of high-risk~     pancreatic remnants.~   "
27107|NCT03212183|"~     The purpose of this pilot randomized controlled trial is to evaluate a web-based virtual~     nursing intervention (ÉPI-TAVIE) in terms of 1) acceptability and feasibility, and; 2)~     preliminary efficacy.~   "
27108|NCT03212170|"~     The goal of this research is to test the accuracy of PET/MRI imaging with~     18F-fluorofuranylnorprogesterone (FFNP) for measuring progesterone receptor (PR) expression~     in patients with invasive breast cancer. We hypothesize that FFNP SUVmax from PET/MRI will~     correlate well against the semi-quantitative PR immunohistochemistry score.~   "
27109|NCT03212157|"~     The roles of imaging in cancer may be divided into that of diagnosis and tumour detection,~     staging and assessment of response to treatment. Standard radiological techniques include~     ultrasound, Computed Tomography (CT), Magnetic Resonance Imaging (MRI) and Positron Emission~     Tomography (PET). A combination of imaging techniques is often necessary to differentiate~     between cancerous and normal tissue. Traditional imaging techniques identify cancers by their~     gross appearance and structural/ cellular characteristics, whilst PET do so by tracking~     glucose metabolism. PET owes its specificity to the high rate of glucose metabolism seen in~     most cancers. However it is not used routinely due to a lack of availability and high costs.~     In addition, PET is often used in combination with CT, which imparts a significant diagnostic~     radiation dose. This can increase an individual's risk of cancer, especially with childhood~     or early adult exposure. In contrast, MRI is more readily available and does not involve~     radiation. However its ability to detect cancer by tracking glucose metabolism has not been~     widely explored. Our group has recently developed a novel MRI technique called Gluco-CEST~     that can image glucose delivery, uptake and metabolism in cancer, therefore potentially~     allowing a radiation-free, one-stop imaging service that can be adapted to current generation~     of MRI scanners. This study aims to optimise the GlucoCEST technique, after which it will be~     rigorously tested and compared to standard imaging parameters and clinical or pathological~     reference standards to evaluate its diagnostic and predictive power across a number of cancer~     populations.~   "
27110|NCT03212144|"~     This study will enroll and randomly assign 30 sedentary, healthy overweight men and women to~     two groups. Participants will either start by consuming peanuts for 4 weeks, and then go on~     to exercise at high intensity intervals (HIIT) for 4 weeks, or the reverse order. The study~     will test and compare the effect of peanuts and exercise on inflammation and heart rate~     variability as indicators of heart health. Specifically, the study will measure inflammation~     in the blood because there is evidence that higher inflammation is found in heart disease~     patients. There is also evidence that inflammation is related to death as a result of heart~     disease in healthy individuals. Finally, there are ongoing trials targeting these markers to~     improve heart health. The study hypothesizes that peanuts and exercise will reduce~     inflammation. It is also expected to find less inflammation because exercise and peanut~     consumption activate a part of the nervous system that has been shown to cause a similar~     effect.~      Additionally, previous studies show that inflammation involves the mitochondria in the cell,~     the part of the cell that produces energy. For this reason, it is expected that exercise and~     peanuts will cause changes in the mitochondria. The study will test and compare mitochondrial~     activity in response to peanut consumption and exercise.~   "
27111|NCT03212131|"~     This trial is conducted in Europe. The aim of this trial is to investigate the effect of~     abnormal liver (hepatic) function on the amount of trial drug getting into the body and~     removal of the drug from the body (this is called pharmacokinetics).~      In this trial the participants will receive three subcutaneous (under the skin) injections of~     the trial drug somapacitan. Somapacitan is a long-acting growth hormone analogue (a drug~     similar to human growth hormone) intended for once-weekly subcutaneous administration.~   "
27130|NCT03211884|"~     The primary aim of the proposed study is to assess the efficacy of PST for positively~     impacting distressed military family caregiver's burden, and depression levels, ultimately~     enhancing their mental health QOL (primary outcomes). Data will also be collected to~     characterize physical and social stressors for these caregivers such as illness that limits~     the caregiver's activities, new household management and caregiving responsibilities,~     satisfaction with social roles and activities, lifestyle constraints, the quality of the~     marital relationship, perceived social support, and demographic factors. A secondary aim of~     the proposed study is to determine which of a series of key caregiver sociodemographic~     factors moderate PST- intervention efficacy for caregiving burden and mental health QOL~     outcomes~   "
27112|NCT03212118|"~     Long-term sickness absence has considerable impact on social functioning, families involved,~     the employer, and society as a whole. Preventing long-term sickness absence and increase the~     likelihood of return to work (RTW) are critical concerns for industrialized countries across~     the world. Motivational factors contributing to RTW and maintenance of work participation are~     therefore of importance to explore in order to get the person back to work after long-term~     sick leave. Motivational interviewing (MI) is an empirically validated psychological approach~     that may be particularly useful in a RTW context. Even though MI has been widely studied and~     is considered a flexible intervention strategy in different domains, its effectiveness in~     improving RTW has not yet been studied.~      The aim of this study is to evaluate whether MI provided by trained caseworkers at The~     Norwegian Labour and Welfare Administration (NAV) to sick-listed users with unselected~     diagnoses facilitates RTW compared with follow-up as usual.~   "
27113|NCT03212105|"~     The purpose of this study is to determine within a randomized controlled trial the~     feasibility of a 60-second acceptance based mindfulness exercise for patients with~     musculoskeletal pain versus usual medical care. Feasibility will be evaluated as the number~     of individuals approached who agree to participate and the number of individuals who drop out~     prior to completion of post intervention questionnaires.~      The investigators aim to determine the usefulness and acceptability of the 60-second~     acceptance based mindfulness exercise for patients with musculoskeletal pain as compared to~     usual medical care. Usefulness and acceptability will be assessed with the Client~     Satisfaction Scale-3 (CSQ-3).~      The investigators also aim to determine whether participating in a personalized 60-second~     acceptance based mindfulness exercise (e.g., intervention) is associated with significantly~     more improvement in patients' ratings of state anxiety and pain intensity (co-primary~     outcomes), and to determine if Distress, Anxiety, Depression and Anger (secondary outcomes)~     decrease compared to a brief educational pamphlet (e.g., control).~      The investigators also aim to determine whether any improvements observed will maintain~     within a 3 month follow up.~   "
27114|NCT03212092|"~     The study is an randomised controlled trial (RCT) to test whether supplementation of~     vitamins, minerals and n-3 fatty acids may reduce aggressive behavior in people with~     intellectual disabilities.~   "
27115|NCT03212079|"~     PATH is a research study for cancer survivors to help participants to become more active.~     Studies suggested an association between inactivity and cancer. The investigators created new~     novel ways and technologies that may help participants to become more active. The three~     methods the investigators are studying are: 1) participant become active on her/his own;~     educational material will be provided; 2) working with a programmed health coach over the~     phone via text messages; and 3) using digital voice assist to help participant become more~     active. The digital voice assist will be delivered via Amazon Alexa on Echo speaker (it is~     the famous intelligent voice that you see in superball commercial by Alec Baldwin). This~     study is funded by the State of Maryland.~   "
27116|NCT03212066|"~     The purpose of this study is to conduct a randomized controlled trial to evaluate the~     efficacy of the Master Mind program, a mindfulness education substance abuse prevention~     program. The program has the goal of enhancing coping strategies and decision-making skills~     and preventing substance abuse in late elementary school students.~   "
27117|NCT03212053|"~     There is no prospective study published on the Essential Thrombocythemia and the correlation~     between this specific disease, its complications and the biological variations observed.~      The aim of this study is to demonstrate a correlation between biological tests of~     haemostasis, as Multiplate analyser and thromboelastometry (ROTEM) and the occurrence of~     clinical complications, thrombosis and/or haemorrhage, in order to determine if this~     biological tests could be biological prognostic factors~   "
27118|NCT03212040|"~     Comparison of biopsy needles with a different diameter, i.e. 14 vs 16 gauge, used for breast~     biopsies~   "
27119|NCT03212027|"~     The aim of this study is to analyze aquaporins expression of thymic epithelial tumors and to~     compare them with apparent diffusion coefficient(ADC) from ultra-high b-values, and to test a~     possibility of use of ADCuh to identify the pathological type of tumor.~   "
27120|NCT03212014|"~     The present study aims to compare the clinical efficacy of intelligent POWER therapy,~     intelligent LSVT-BIG therapy, and the three exercise models currently in clinical use. DCM_IR~     analysis will also be incorporated into the analysis to develop a personalized and~     intelligent Parkinson's rehabilitative therapy platform.~   "
27121|NCT03212001|"~     The goal of this study is to evaluate the overall impact of Telehomecare on COPD and HF~     patients and system level outcomes using a comparison group of patients that did not~     participate in the program (for up to 18 months). This evaluation study will explore costs,~     participants' experiences, perceptions, and patterns of use related to Telehomecare. The~     study will include eight Local Health Integration Networks (LHINs) across Ontario, Canada.~   "
27122|NCT03211988|"~     This is an open-label, single arm, multi-center Phase II trial of entinostat given as a 5 mg~     oral dose every week (days 1, 8, 15, and 22 of a 4-week cycle) in patients with relapsed or~     refractory abdominal neuroendocrine (NE) tumors. Patients will continue on treatment until~     disease progression or intolerable toxicity occurs.~   "
27131|NCT03211871|"~     The aim of this study was to evaluate efficacy and safety of dexmedetomidine infusion during~     laparoscopic cholecystectomy. The randomized, single-center, controlled study was carried out~     from May 2016 to June 2017 at department of surgery, anesthesiology and intensive care,~     Postgraduate Institute of Bogomolets National Medical University.~   "
27132|NCT03211858|"~     Primary Objective:~      To demonstrate non-inferiority of SAR341402 versus NovoLog/NovoRapid in glycated hemoglobin~     A1c (HbA1c) change from baseline to Week 26 in patients with type 1 or type 2 diabetes~     mellitus (T1DM or T2DM) also using Lantus®.~      Secondary Objectives:~        -  To assess the immunogenicity of SAR341402 and NovoLog/NovoRapid in terms of~          positive/negative status and anti-insulin antibody (AIA) titers during the course of the~          study.~        -  To assess the relationship of AIAs with efficacy and safety.~        -  To assess the efficacy of SAR341402 and NovoLog/NovoRapid in terms of proportion of~          patients reaching HbA1c <7.0% and change in HbA1c, fasting plasma glucose (FPG), and~          self-measured plasma glucose (SMPG) profiles from baseline to Week 26 and Week 52 (only~          Week 52 for HbA1c).~        -  To assess safety of SAR341402 and NovoLog/NovoRapid.~   "
27123|NCT03211975|"~     Infectious endocarditis (IE) is the localization and proliferation of blood-borne germs in~     the endocardium. It remains a complicated disease to manage due to its low incidence,~     diagnostic difficulties, the change in epidemiology in recent decades and high mortality~     rates. The annual incidence is estimated at 3-10 cases per 100,000 people.~      The epidemiology of AR has changed significantly in recent years due to new risk factors.~     Indeed, the frequency of rheumatic heart disease, which was the first predisposing factor,~     decreased markedly in the industrialized countries, replaced by new predisposing factors: the~     presence of valvular prostheses or intracardiac materials (the risk of AR is multiplied by 50~     Compared with the general population), hemodialysis, nosocomial infections,~     immunosuppression, increased use of injectable treatments and, above all, an aging population~     with an increase in degenerative diseases such as aortic stenosis and l Mitral insufficiency.~      The diagnosis of IA is based on DUKE criteria. But the clinical presentation is sometimes~     atypical especially in case of infection on prosthesis where the diagnosis is based mainly on~     the results of the blood cultures and the ultrasound data.~      The lesions visualized in ultrasound are: vegetations, abscesses, pseudo-aneurysms and~     fistulas constituting the degenerated abscess evolution, the perforation of the cusps of the~     native valve or the bioprosthesis giving rise to a jet of Eccentric regurgitation.~      The evolution of endocarditis and its prognosis vary according to many factors: the type of~     germ responsible, the precocity of the diagnosis, the existence of a complication, the site~     of occurrence. These complications of endocarditis are frequent, sometimes revealing. EI is~     complicated by heart failure, atrioventricular conduction disorders, peri-vascular abscesses,~     embolic, neurological, renal and septic complications. Despite improvements in diagnosis and~     therapeutic methods, diagnosis is sometimes difficult, management remains very complicated~     and morbidity and mortality remain high. Studies are still needed to study the prognosis and~     to determine the predictive factors for hospital mortality and long-term mortality.~   "
27124|NCT03211962|"~     Transient renal insufficiency is frequently observed in the course of cardiovascular arrest.~     Although elevation of creatinine is reversible in a large majority of cases, severe renal~     insufficiency is sometimes observed and is associated with a dark prognosis. Any intervention~     that may limit the worsening of renal function may have an impact on patient mortality. There~     is currently no validated pharmacological treatment to limit the progression of ARI or to~     accelerate its recovery. A major challenge then concerns the detection of the reversible~     character of renal damage.~      Renal biomarkers have been little studied in the prediction of severe ARI and mortality after~     cardiac arrest. The combination of TIMP2 (tissue inhibitor of metalloproteinase) and~     insulin-like growth factor binding protein (IGFBP7) in urine showed good diagnostic~     performance in the early detection of the risk of developing acute renal failure within 12~     hours. Measured in the urine, the excretion of these two markers specifically reflects renal~     tubular lesions. Moreover, their rate seems to be strongly correlated with the severity of~     the tubular lesions.~      Thus, it can be reasonably assumed that their very early dosing in post-cardiac arrest could~     detect the presence and severity of renal tubular lesions. A threshold to be defined would~     discriminate patients at risk of developing an ARI within 48 hours post ACR and to~     distinguish between severe transient and severe persistent lesions beyond 72 hours.~   "
27125|NCT03211949|"~     Blocking the medial antebrachial cutaneous nerve (MACN) during an axillary block often a~     subcutaneous wheal of local anesthetics is made what is described as painful. With the~     improvement of the resolution of the ultrasound machines smaller structures and nerves can be~     visable. In this study topographic assessment will made of the anatomical variation of the~     medial antebrachial cutaneous nerve (MACN) by ultrasound in the axilla and 5 cm above the~     cubital fossa of the arm.~   "
27126|NCT03211936|"~     Patients submitted to general anesthesia and artificial ventilation almost always develop~     pulmonary atelectasis, which can determine adverse consequences both intraoperatively and~     postoperatively. It is recommended to use physiological tidal volume (6 - 8 mL / kg of ideal~     body weight) during the intraoperative period in order to minimize the risk of lung injury.~     To prevent the formation of atelectasis, minimizing the risk of complications, the use of~     PEEP has been recommended. At present, there is no way to make an optimal adjustment of PEEP~     to the needs of each patient, seeking a value that keeps the alveoli open without forming~     atelectasis and also without areas of hyperdistension.~      The aim of this study was to evaluate the agreement between the ultrasound and the electrical~     impedance tomography - Timpel® (TIE) to detect the beginning of the formation of areas of~     atelectasis after pulmonary recruitment, with decreasing PEEP values. In addition, the lung~     ultrasound will be validated for intraoperative use for both adequacy of PEEP, as well as~     quantitative analyzes of ultrasound images to assess atelectasis.~      18 patients (> 18 years) of both sexes, submitted to general anesthesia, will be~     prospectively studied. All patients will receive, in addition to the usual monitoring, the~     monitoring with the electrical impedance tomography and chest ultrasonography, after being~     anesthetized and under neuromuscular block, being ventilated with an inspired fraction of 50%~     oxygen (or greater to maintain oxygen saturation > 96% ), Tidal volume of 6 mL / kg and~     respiratory rate to maintain expiratory tidal CO2 between 35-45 cmH2O.~   "
27127|NCT03211923|"~     The aim of this study is to quantify muscle relaxation properties of the finger flexor~     muscles in patients with different myopathies. The inhibiting effects of transcranial~     magnetic stimulation (TMS) on the cortical motor hand area are used to induce relaxation,~     which in turn will be monitored with handgrip dynamometry and EMG. The investigators will~     evaluate if this technique can be implemented as a diagnostic tool in clinical practice.~      Muscle relaxation is an often overlooked property of the muscle as compared to muscle~     strength or activation. Muscle relaxation is affected in different myopathies, such as~     myotonic dystrophy, non-dystrophic myotonias, and Brody myopathy. Therefore, a diagnostic~     tool to quantify muscle relaxation is of clinical and scientific importance. In this study,~     transcranial magnetic stimulation (TMS) is used, in combination with a dynamometer to~     quantify muscle relaxation properties.~      Transcranial magnetic stimulation (TMS) is a non-invasive technique that is commonly used to~     stimulate the brain. In practice, a circular coil is held directly above the scalp, upon~     which a strong current pulse induces a magnetic field that stimulates the underlying~     superficial brain areas. This stimulation can have both activating and inhibiting effects.~      When the motor cortex (i.e. the area of the brain that controls muscle contractions) is~     strongly stimulated with TMS during a voluntary muscle contraction, both excitatory and~     inhibitory effects can be observed in the muscle the targeted cortical area controls. The~     inhibitory effect entails a transient interruption of neural drive to the muscle. This~     interruption, called the silent period, lasts for less than half a second and results in~     the relaxation of the muscle. Muscle activity and control quickly return to normal after the~     silent period.~      The elegance and main advantage of TMS-induced muscle relaxation lies in the fact that it~     excludes all voluntary influences on the relaxation process. Furthermore, the TMS pulse~     causes all muscle fibres involved in the contraction just prior to the onset of the silent~     period to relax simultaneously. This allows us to study muscle relaxation as only a property~     of the muscle, i.e. without voluntary influences.~      In this study, the investigators will measure muscle relaxation in several myopathies~     (McArdle disease, Nemaline myopathy type 6 and myotonic dystrophy type 2) and compare this to~     healthy controls and to controls with no myopathy but with similar complaints (myalgia,~     stiffness, cramps). The data from these two control groups has been gathered previously in a~     different study. The investigators will also compare this to patients suffering from Brody~     disease who were previously measured in a different study.~      Muscle relaxation will be evaluated in fresh and fatigued finger flexor muscles. The main~     outcome of this study is the peak relaxation rate normalized to the peak force preceding~     relaxation.~      The final outlook of this research is to evaluate whether muscle relaxation studied with TMS,~     can be used for different myopathies as a diagnostic tool, to monitor disease progression,~     and to study the effects of different interventions (e.g. medication, exercise).~   "
27128|NCT03211910|"~     The purpose of the study is to investigate the ability of the product Sacral Saver, to~     prevent and /or help healing bed sores.~   "
27129|NCT03211897|"~     The goal of this research investigation is to conduct a prospective observational study of~     the comparative efficacy of haloperidol versus olanzapine versus midazolam versus ziprasidone~     for the treatment of acute undifferentiated agitation in the emergency department.~   "
27133|NCT03211845|"~     An optimal nutritional status is essential for healthy ageing. Telemonitoring might~     contribute to maintaining or improving nutritional status in elderly people.The objectives of~     this pilot study are to test the feasibility, acceptability and implementation fidelity of~     telemonitoring of nutritional parameters in community-dwelling older adults; to test the~     study procedures for effect evaluation; and to determine the likelihood of achieving desired~     impact on the primary and secondary outcomes.~   "
27134|NCT03211832|"~     The purpose of this study is to identify and evaluate dissemination strategies to support the~     uptake of evidence-based programs and policies (EBPPs) for diabetes prevention and control~     among local-level public health practitioners. Dissemination strategies such as multi-day~     in-person training workshops, electronic information exchange modalities, and remote~     technical assistance are hypothesized to associate with improved access and use of public~     health evidence and organizational supports for program and policy decision making based on~     evidence-based public health.~   "
27135|NCT03211819|"~     Patients with fractured anterior teeth indicated for extraction will be recruited to the~     study. After Extraction of the tooth the socket will be evaluated and if eligible for~     immediate implant placement, implants will be placed either by free hand or computer guided~     technique. The pink esthetic score will be evaluated to be the primary outcome.~   "
27136|NCT03211806|"~     The goal of this research is to develop and test a technology-supported intervention to~     reduce sedentary behavior before and after cancer surgery. Surgical oncology patients are at~     elevated risk for postoperative complications and readmissions. Sedentary behavior increases~     markedly after surgery and hospitalization, and reducing sedentary behavior around the time~     of cancer surgery could reduce risk while also empowering cancer patients to take a more~     active role in their recovery.~   "
27137|NCT03211793|"~     The MANUS Trial aims to examine the safety, feasibility and potential efficacy of~     intramuscularly injected allogeneic mesenchymal stromal cells as treatment for digital ulcers~     of systemic sclerosis.~   "
27138|NCT03211780|"~     Using the analysis of group velocity for a screening application and then higher order~     analysis based on the elastic and viscious components of the shear modulus may allow~     discrimination between extent of tumor invasion through the esophageal wall if appropriately~     correlated with pathological findings.~   "
27139|NCT03211767|"~     The primary objective of this trial is to assess the effect of consumption of aged garlic~     extract powder on 24 h systolic and diastolic ambulatory blood pressure in hypertensive~     individuals following 8 weeks of supplementation.~      Additional secondary objectives are to assess the effects of aged garlic extract powder~     intake for 8 weeks on lipid profile (TC, HDL-C, LDL-C, and TG concentrations), blood glucose,~     office blood pressure, pulse-wave velocity and augmentation index, body mass index, and waist~     and hip circumference.~   "
27140|NCT03211754|"~     In this work, the investigators report the effects of consume of 15g walnuts and 15g almonds~     for 8 week on weight, waist and hip circumferences, body mass index, fat mass, serum~     LDL-cholesterol adiponectin, lipocalin-2 concentration and fatty acids profile.~   "
27141|NCT03211741|"~     Although the safety and efficacy of bevacizumab has been established in several phase 3~     trials, there is only little documented about the long-term safety and efficacy in the~     'real-world practice' in large populations from different regions.~      Therefore the investigators evaluate the long-term safety and efficacy of intravitreal~     treatment with bevacizumab by registration of best corrected visual acuity, side-effects and~     central retinal thickness as measured with the ocular coherence tomography if available. This~     will allow the investigators to compare the results of their centre with the results of~     several phase 3 trials from the literature and will guide improvements in their treatment~     protocols.~   "
27142|NCT03211728|"~     The investigators hypothesize that perioperative oral administration of pregabalin would~     reduce postoperative pain and produce reduction in postoperative opioid consumption after~     anterior cruciate ligament (ACL) reconstruction . Patients are randomly assign to 1 of 2~     groups. The placebo group receive placebo capsules 1 hour before surgery and 12 hours after~     initial dose. The pregabalin group receive pregabalin 150 mg, respectively at the same~     points.~   "
27143|NCT03211715|"~     In contemporary era of rectal cancer treatment, development of surgical technique and tool,~     adaptation of chemoradiation therapy, as well as multidisciplinary approach have led~     increased survival as well as rate of sphincter preservation. However, poor anorectal~     function, such as fecal incontinence and/or urgency, has also been increased. Such anorectal~     dysfunction is named as low anterior resection syndrome, and its rate has been reported in 40~     to 90% in rectal cancer patients who received sphincter preserving surgery. Low anterior~     resection syndrome is known to debilitate quality of life in survivors of rectal cancer.~     Previously, several studies attempted to evaluate the low anterior resection syndrome via~     questionnaires and scoring system. Adapting the low anterior resection syndrome score system~     created in Denmark, this study investigates the validity of the scoring system in Korean~     language.~   "
27144|NCT03211702|"~     This study will validate the impact of comprehensive geriatric assessments using activity of~     daily living (ADL), instrumental activity of daily living (IADL), and Charlson's comorbidity~     index (CCI) on survival and toxicities in Korean patients with diffuse large B-cell lymphoma~     (DLBCL) treated with R-CHOP.~   "
27145|NCT03211689|"~     This aim of this research project is to determine if low to moderate level exercise can have~     an impact on stress, fatigue, and quality of life for individuals diagnosed with a primary~     immunodeficiency disease. This 8-week study will compare participants engaging in a~     semi-customized, home exercise program (exercise intervention group) to participants~     performing normal activities (non-exercise control group). This study will track stress,~     fatigue, and quality of life in individuals with a diagnosis of primary immunodeficiency~     disease, using standardized questionnaires, journals, and interviews.~   "
27146|NCT03211676|"~     The aim of this study is to evaluate the removal of midle molecules and inflammatory~     cytokines with the Theranova-500 ™ dialyzer (medium cut-off membrane, Baxter®) versus a high~     flux dialyzer Elisio-21H ™ (High-flux membrane, Nipro®) in chronic hemodialysis.~      Evaluation of nutritional parameters, inflamatory parameters and oxidative stress will also~     be carried out.~      Finally, the investigators will compare hepcidin levels and the erythropoietin resistance~     index between the two groups.~   "
27151|NCT03211611|"~     The aim of this study is to determine general practitionners' role in management of women~     with BRCA1/2 mutation.~      This study will be conduct between April 2017 and December 2017 at Montpellier University~     Hospital on women followed-up in the department of genetics and their general practitionners~     (GP). Patients and their GP will be called by the investigators and questionnaire will be~     given to them. Questionnaire includes questions for patients and their GP. The primary~     endpoint was to determine the rate of GP having sufficient knowledge of the adequate~     management of patients with BRCA1 / 2 mutation. Adequate knowledge includes : systematic~     search for a family history of cancer, knowing criteria required to refer women in~     oncogenetic department, and the ability to respond to patients' questions. Secondary endpoint~     was to determine women' opinion on their GP : whether or not well managed for their BRCA 1 /~     2 mutation.~   "
27152|NCT03211598|"~     The purpose of this study is to determine the feasibility and safety of the Surefire Infusion~     System (SIS) for delivery of Drug Eluting Beads Transcatheter Chemoembolization (DEB-TACE) in~     the HCC population. This study will allow us to determine the effectiveness of SIS for HCC in~     terms of disease response.~   "
27153|NCT03211585|"~     The purpose of this study is to further quantify the safety and effectiveness of the~     Syneron-Candela long pulse-duration, extended sub-pulse, larger spot-size prototype Perfecta~     V-Beam, 595nm laser system for the treatment of facial redness associated with flushing and~     blushing, or rosacea. The Perfecta laser system is expected to provide effective treatment of~     rosacea with less bruising or purpura and greater effectiveness than previous generation~     systems. This study should enable optimization of treatment parameters for using the Perfecta~     595nm laser for treating rosacea.~   "
27154|NCT03211572|"~     Evaluating Multiparameter Gene Testing as a Predictor of Short Term Endocrine Therapy~     Response in Hormone Receptor Positive Breast Cancers~   "
27155|NCT03211559|"~     The aim of our study is to investigate the effect of Clinical Pilates Exercises on functional~     status and quality of life when applied together with aerobic exercise in patients with~     ankylosing spondylitis (AS).~   "
27156|NCT03211546|"~     Prospective data collection and evaluation of complete data sets will be performed in the~     course of routine clinical care of a cohort of consecutive patients (children up to 16 years~     old) presenting with an isolated femur shaft fracture. Data will be collected during~     follow-up visits at 3 to 6 weeks, 3, 6, 12 and 24 months, with additional follow-up visits as~     needed or dictated by individual practice. Final follow-up will be at 24 months, unless a~     patient requires additional follow-up or another intervention to address an unfavorable~     outcome (e.g. malalignment, nonunion, limb length discrepancy) noted at the 24 month~     follow-up visit.~   "
27157|NCT03211533|"~     This observational study aims to early identify, through a rigorous and standardized~     follow-up, infants at high risk for Cerebral Palsy. After the consent agreement firmed by the~     parents, infants born at term or preterm with ultrasonographic evidence of brain injury~     considered at risk for neurodevelopmental disorders will be strictly monitored during the~     first months of life performing a periodic neurological assessment (Prechtl's General~     Movement (GMA) and the Hammersmith Infant Neurological Examination) at term age and around 3~     months of post term age. Moreover, to study more accurately the brain injury early identified~     by ultrasonographic brain exam, around 6 weeks of post-term age the enrolled infants will~     perform, as recommended in infants at risk, brain Magnetic Resonance (RM).~      Thanks to the high predictability power of the combination of the clinical observation with~     the neuroimaging infants at high risk of CP will be early detect. Selected infants,~     considered at high risk for CP will have the opportunity to perform an home based and family~     centered early intervention later than 3 post term age.~   "
27158|NCT03211520|"~     The study is being conducted to see which cardiac tests that monitor how the heart functions~     during and after treatment with anthracyclines are most effective. This study will assess a~     new way to check the heart function of children during and after cancer treatment. Currently,~     doctors use echocardiograms (heart ultrasound) to see how the heart is working.~     Echocardiograms are currently being done as part of standard of care prior to giving~     anthracycline chemotherapy doses and if any cardiac problems are suspected. The new method~     involves Cardiac Magnetic Resonance Imagining (CMRI) and a blood tests for certain biomarkers~     for heart health: High sensitivity troponin, Caspase, C-reactive Protein (CRP), ventricular~     derived B-type natriuretic peptide (BNP), Matrix Metalloproteinases (MMPs), Tissue inhibitors~     of metalloproteinases (TIMPs), C terminal propeptide of type I procollagen (PICP), C terminal~     telopeptide of collagen type I (CITP), Troponin I, and Bone Alkaline Phosphatase. The purpose~     of this study is to find out if CMRI and blood tests help us to find heart problems earlier,~     before they are detected by echocardiograms.~   "
27159|NCT03211507|"~     A case-control study to investigate whether job exposures are an under-recognized cause of~     idiopathic pulmonary fibrosis (IPF) using an interview to collect information about previous~     jobs and a blood test to investigate genetic susceptibility.~   "
27160|NCT03211494|"~     The objective of this crossover study and randomized controlled trial (RCT) is to compare ΔP~     levels during INTELLiVENT®-ASV with conventional lung protective ventilation in the acute and~     sub-acute phase of moderate or severe ARDS.~      A total of 48 adult patients admitted to intensive care units with moderate or severe ARDS~     will be included. In the acute phase patients will receive 4 hours of INTELLiVENT-ASV~     ventilation and 4 hours of conventional lung protective ventilation in random order. After~     these two blocks the patients are allocated into either the INTELLiVENT-ASV arm or the~     conventional lung protective ventilation arm.~      in the sub-acute phase patients will be assessed every day until day 7 or extubation,~     whichever comes first.~      Primary endpoint is the transpulmonary transpulmonary (ΔP). Secondary endpoints of both~     studies include other ventilator settings and ventilation parameters, as well as time spent~     at a ΔP level of 15 cm H2O or higher.~   "
27231|NCT03210571|"~     This study aims to test a new medical device, called the eyeWatch, used in filtering surgery~     for the treatment of glaucoma. This medical device has the following property: it allows~     better control of intraocular pressure in the initial postoperative phase by adjusting~     aqueous flow going through the device. The target criteria for the study are defined as:~     keeping intraocular pressure in target range; reducing the number of anti-glaucoma drugs;~     evaluating the number and type of postoperative complications. So far, this device has been~     already tested on 20 patients in Switzerland.~   "
27161|NCT03211481|"~     Uterine fibroids are benign uterine masses that can be removed through a surgical procedure~     called a myomectomy. Myomectomy is often associated with a significant amount of blood loss~     for the patient. The large volume of blood lost can increase post-operative complications and~     lead patients to require blood replacement (blood transfusion). To reduce the amount of blood~     lost during the surgical procedure and the need for blood transfusions, interventions such as~     medications and surgical techniques have been used. While evidence in the literature exists~     for these techniques, there is no standardized approach to this problem in clinical practice.~     The objective of this study is to create a novel intra-operative blood conservation pathway,~     using a modified Delphi expert consensus approach, to decrease the amount of blood lost~     during myomectomy.~      The current study is expected to benefit patients undergoing myomectomy through an improved~     surgical experience, reduction in blood transfusion rates, and reduction in associated~     complications.~   "
27162|NCT03211468|"~     A controlled, randomized clinical intervention study which includes the development and~     activation of an intervention program designed to prevent eating disorders among adolescent~     female aesthetic athletes. Our hypothesis is that the intervention program will yield~     improvement in the participants' eating behaviors, drive for thinness, and body image as~     compared with the age matched control group. Results will be measured using the study~     questionnaire, to be filled out by the participants before, after, and three months after the~     completion of the program. The Questionnaire will include validated questionnaires with good~     psychometric qualities.~   "
27163|NCT03211455|"~     Although peroperative intravenous lidocaine has been shown to be useful in early recovery~     after colorectal surgery, its beneficial effect on the specific population of obese patients~     scheduled for bariatric surgery remained unknown.~      Investigators hypothesized that peroperative intravenous lidocaine could decrease~     postoperative opioid consumption and improve postoperative recovery~   "
27164|NCT03211442|"~     MEDIRAD-BRACE aims to determine the relationship between 3D dose distributions in cardiac~     structures and the risk of acute coronary events (ACE) and other cardiac complications in~     breast cancer (BC) patients to develop and externally validate multivariable Normal Tissue~     Complication Probability (NTCP) models to assess the risk of ACE in individual patients based~     on cardiac dose metrics in the first 10 years after BC radiotherapy.~   "
27165|NCT03211429|"~     Fear of falling is a major health problem among community-dwelling older adults that may~     contribute to avoidance of activities that they are capable of performing. Studies show that~     the fear of falling may lead to a continual, complex decline in older adults that includes a~     loss of auto efficacy, restriction of physical activities and social participation, physical~     frailty, falls and disability. Apart from these effects, the fear of falling may also have~     financial implications for health care systems and the general public. Several interventions~     have been shown to reduce fear of falling with multifactorial interventions, including~     physical and behavioral components, being most successful. Behavioral components usually~     comprise strategies to reduce catastrophic thinking and fear-related avoidance behaviors~     while physical components usually comprise falls prevention exercise programs. However,~     multifactorial programs are not always feasible or preferred by older people. In this~     framework, the objective of this works is to assess the effects (benefits and effectiveness)~     of three interventions programs (Tai Chi, postural control exercises and behavioral therapy~     intervention) to improve functionality and decrease fear of falling in older people living in~     the community.~   "
27166|NCT03211416|"~     This phase Ib/II trial studies how well sorafenib tosylate and pembrolizumab work in treating~     patients with liver cancer that has spread to other parts of the body. Sorafenib tosylate may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~     Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells~     to grow and spread. Giving sorafenib tosylate and pembrolizumab may work better in treating~     patients with liver cancer.~   "
27167|NCT03211403|"~     This is a single-Center, randomized, double-Blind, placebo-controlled, multiple~     ascending-dose Phase I trail.~   "
27168|NCT03211390|"~     The purpose of this study is to test the reliability of using telemedicine so a neurologist~     can remotely identify residents of a long-term care facility who should be referred to a~     neurologist for an in-person spasticity consultation.~   "
27169|NCT03211377|"~     This is a non-interventional study to observe the safety and efficiency of chemotherapy for~     potentially resectable locally advanced esophagogastric junction~   "
27170|NCT03211364|"~     One of the main complications after stroke is hemiplegic shoulder pain. It is known that one~     of the most frequent causes of hemiplegic shoulder pain is a restricted range of motion in~     the shoulder joint. Therefore, it is necessary to preserve the passive range of motion by~     using the most optimal mobilization technique. The aim of this study is to compare 2~     different techniques in order to document their influence on shoulder range of motion and~     shoulder pain in stroke patients.~   "
27171|NCT03211351|"~     With the potential to address evaporative dry eye, Liposic and Tears Naturale Forte have been~     developed in which phospholipid liposomes are delivered to the tear film via the surface of~     the closed eyelid. This study compare the effects of Liposic and Tears Naturale Forte~     application on the lipid and stability of the tear film in dry eye patients~   "
27172|NCT03211338|"~     The aim of this study is to investigate the In Vitro and In Vivo effect of progesterone on~     immature myeloid cells (IMC), inflammation characteristics and maturation into dendritic~     cells (DC).~   "
27173|NCT03211325|"~     The investigators seek to perform a comparative transcriptome analysis of TRP channels~     residing in the skin between primary and scleroderma secondary Raynaud's phenomenon and~     healthy subjects.~   "
27174|NCT03211312|"~     This study intends to investigate the relevant risk factors of perioperation complications or~     mortality in older patients with cardiac diseases undergoing teeth extraction surgery and~     this study aims to quantify the risk factors and then to establish the predictive scoring~     systems.~      Hypothesis:Preoperative parameters could predict postoperative complications.~   "
27342|NCT03209102|"~     This study aims to better understand the behavioral, neurobiological and hormonal~     underpinnings of stress and reward reactivity of adolescents suffering from borderline~     personality disorder compared to healthy adolescents by a multimodal approach based on~     clinical assessments, structural and functional mri and experimental acute stress exposure.~   "
27175|NCT03211299|"~     Excessive fat in the liver, in absence of high alcohol consumption, is diagnosed as~     non-alcoholic fatty liver (NAFL). NAFL prevalence is as high as 50-70% in obese people and is~     associated with impairments in metabolic health, e.g. insulin resistance. Not only the~     amount, but also the composition of the fat stored in the liver appears to be linked to~     health outcome measures, such as insulin resistance, but this evidence comes mainly from~     animal studies. Since fat composition has been linked to health outcome measures, it is~     important to understand what determines the fatty acid composition of liver fat. De novo~     lipogenesis (DNL) and adipose tissue fat composition are factors that could determine liver~     fat composition. Since the end product of DNL are saturated fatty acids and as the majority~     of fatty acids in the liver originate from adipose tissue, both may influence hepatic fatty~     acid composition profoundly. Here, our primary hypothesis is that DNL is associated with the~     relative amount of saturated fatty acids in the liver in overweight/obese humans differing in~     liver fat content. Furthermore, we hypothesise that adipose tissue fat composition is~     associated with liver fat composition and that liver fat composition is associated with~     liver, muscle and whole body insulin sensitivity in overweight/obese humans differing in~     liver fat content. To this end, liver fat composition, adipose tissue fat composition, DNL~     and insulin sensitivity will be measured in overweight/obese participants differing in liver~     content.~   "
27176|NCT03211286|"~     Studies have shown that hip fractures have a significant perioperative blood loss.~     Postoperative anaemia is associated with a higher morbidity and mortality.~      Tranexamic acid is a safe and effective antifibrinolytic widely used to reduce blood loss in~     other forms of orthopaedic surgery and in traumatized patients. However, evidence on the~     effectiveness of TXA in lower extremity fracture care is more limited.~      Hip fractures represent a common orthopedic injury in a fragile patient population that often~     necessitates post-operative blood transfusion thereby putting the patient at additional risk~     of complications.~      The goal of this study is to assess if the use of tranexamic acid in patients with hip~     fractures will result in a reduction in blood losses and blood transfusion rates.~      Our hypothesis is that by providing intravenous TXA at the time of surgery will decrease the~     amount of preoperative and intraoperative bleeding thereby leading to a decreased need for~     postoperative transfusion.~      This a double blinded, placebo controlled, therapeutic trial in which the patients will be~     randomized to receive TXA or a placebo (saline solution). Treatment will be administered~     pre-operatively as well as at the time of surgical incision. The primary outcome will be need~     for blood transfusion. Secondary outcomes will include calculated perioperative blood loss,~     length of stay, and rate of thromboembolic events, and 90 day mortality.~   "
27177|NCT03211273|"~     In the LIFT study 2000 cancer patients will be recruited at 6 months after diagnosis and~     extensively surveyed over five years on factors that are associated with fatigue.~   "
27178|NCT03211260|"~     Freezing of gait (FOG) is a common disabling condition in Parkinson's disease (PD), causes~     falls, and impairs quality of life. Therapeutic options for this symptom are limited and of~     limited efficacy. Besides, the pathophysiology has been not clarified yet. Proprioceptive~     sensitivity is likely to play a role and recent studies have reported that high-frequency~     microfocal vibratory stimulation exert a modulatory effect of proprioceptive reflex circuits~     and could be considered a valuable treatment strategy. However, evidence is not available.~     The present study was designed to collect preliminary evidence of efficacy of a vibrotactile~     device (Equistasi) for the treatment of FOG.~   "
27179|NCT03211247|"~     The study aims to assess the safety and efficacy of Viaskin Peanut to induce desensitization~     to peanut in peanut-allergic children 1 to 3 years of age after a 12-month treatment by~     EPicutaneous ImmunoTherapy (EPIT).~   "
27180|NCT03211234|"~     To assess the safety and efficacy of repeated intravitreal injections of DE-122 (low dose and~     high dose) given in combination with Lucentis® in subjects with wet age-related macular~     degeneration (AMD) compared with Lucentis® alone.~   "
27181|NCT03211221|"~     The aim of this study is to investigate the effectiveness of low-frequency (1Hz) rTMS~     (repetitive transcranial magnetic stimulation) over the pre-SMA (pre-supplementary motor~     area) in a sample of treatment-resistant OCD patients in a multicenter, controlled design.~   "
27182|NCT03211208|"~     A panel of highly sensitive circulating biomarkers for acute liver injury have been~     identified and demonstrated to identify liver injury on first presentation to hospital before~     standard tests are elevated in patients with paracetamol overdose. The investigators wish to~     test these biomarkers in patients with active and latent tuberculosis to see if they can be~     used to stratify patients undertaking anti-tuberculosis drug therapy. Anti-tuberculosis drug~     induced liver injury is the most frequent side-effect of anti-tuberculosis therapy, affecting~     2-5% of tuberculosis patients seen at the Royal Infirmary Edinburgh and hindering their~     effective treatment. Patients will be recruited from the TB out-patient clinic at the Royal~     Infirmary Edinburgh. Blood samples will be taken every time the patient visits the clinic and~     also retrieved from the biochemistry lab. The biomarkers in the blood samples will be~     analysed to determine if they rise in patients who develop liver injury.~   "
27183|NCT03211195|"~     Primary Objective:~      To determine the bioequivalence of a single dose of the commercial tablet of sotagliflozin~     (test) compared to the development tablet of sotagliflozin (reference) under fasting~     conditions in healthy male and female subjects.~      Secondary Objectives:~        -  To evaluate the single-dose pharmacokinetics of sotagliflozin and its main metabolite~          sotagliflozin 3-O-glucuronide following administration of a single sotagliflozin (test)~          tablet or a single sotagliflozin (reference) table in healthy male and female subjects~          under fasting conditions.~        -  To evaluate safety and tolerability of a single dose sotagliflozin (test) tablet~          compared to a single sotagliflozin (reference) tablet administered under fasted~          conditions in healthy male and female subjects.~   "
27184|NCT03211182|"~     The lifestyle intervention program focusing on healthy dietary habit and exercise effectively~     prevents progression to diabetes. Thus, the purpose of this study was to assess the~     effectiveness of lifestyle intervention program on pre-diabetics subjects in Taiwan.~   "
27185|NCT03211169|"~     Prospective, randomized, multi-center study. Investigators will compare diagnostic yield of~     bile duct brushings, pediatric biopsy forceps biopsies and cholangioscopy-directed biopsies~     for obtaining diagnostic tissue from biliary strictures.~   "
27186|NCT03211156|"~     This is a randomized, double-blind, placebo-controlled Phase 2 study designed to determine if~     amoxicillin will eradicate vaginal colonization/infection with Gardnerella vaginalis (GV)~     when administered to women who are colonized/infected with GV but have no clinical evidence~     of Bacterial Vaginosis (BV). The study will be conducted at 2 clinics in the United States:~     University of Alabama at Birmingham and Wake Forest University Health Sciences. Entire study~     duration is approximately 24 months and subject participation duration is approximately 22~     days. Approximately 245 healthy adult females, 18 to 45 years of age will be screened to~     enroll approximately 98 participants to achieve 82 evaluable participants at the test of cure~     (ToC) visit. Participants will be enrolled and randomized to one of two groups, either~     amoxicillin (2 x 250 mg capsules by mouth twice daily for 7 days) or placebo. Women who are~     enrolled will be asked to return for one further visit, Visit 2 (Day 15 - 21), where a ToC~     will be completed. For those not enrolled, participation will end at their post screening~     follow up phone call. Women will be asked to use condoms during their participation. The~     primary objective is to determine if treatment with amoxicillin eradicates GV in women who~     are colonized/infected with GV but have no clinical evidence of BV.~   "
27187|NCT03211143|"~     A Study to compare Pharmacokinetics, Pharmacodynamics and safety of CKD-381 and D027 in~     healty subjects~   "
27188|NCT03211130|"~     This study evaluated the feasibility and acceptability of using a SystemCHANGE intervention~     in older adult stroke survivors to improve medication adherence. Half the participants will~     receive the SystemCHANGE intervention, while the other half will receive the~     attention-control education intervention.~   "
27189|NCT03211117|"~     This phase II trial studies how well pembrolizumab, chemotherapy, and radiation therapy work~     with or without surgery in treating patients with anaplastic thyroid cancer. Monoclonal~     antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and~     spread. Drugs used in chemotherapy, such as docetaxel and doxorubicin hydrochloride, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy~     x-rays to kill tumor cells and shrink tumors. Giving pembrolizumab, chemotherapy, and~     radiation therapy with or without surgery may kill more tumor cells and work better in~     treating patients with anaplastic thyroid cancer.~   "
27190|NCT03211104|"~     This was a placebo-controlled, double-blind, randomized trial designed with the aim of~     establishing whether curcumin influenced the duration of treatment interruption and rate of~     prostatic specific antigen(PSA) progression, compared with placebo among men with prostate~     cancer receiving intermittent androgen deprivation therapy.~   "
27191|NCT03211091|"~     Patients with stroke were registered based on the WHO/ MONICA protocol and were followed-up~     for 28 days, starting in 2015 in PROVE Registry~   "
27192|NCT03211078|"~     With the increased incidence of lung cancer and prevalence of low dose CT screening, treating~     of early lung cancer has becoming an important issue in the clinical practice of thoracic~     oncology. In this clinical study, the investigators will evaluate whether superDimension~     (superD) ENB (Electromagnetic navigation bronchoscopy) in combination with interstitial~     photodynamic therapy can provide the chance of tumor eradication.~   "
27193|NCT03211065|"~     To study the use of subcutaneous (injected under the skin) immunoglobulin replacement therapy~     (replacement of antibodies, which are infection-fighting proteins) in patients with a type of~     blood cancer called lymphoma, who have been treated with rituximab (a type of chemotherapy)~     and have an abnormal immune system putting them at increased risk of infection.~   "
27194|NCT03211052|"~     This study investigates neoadjuvant TAK-700 orteronel for 6 months prior to prostatectomy.~     The three year biochemical free survival is the primary endpoint. There are a number of 2nd~     endpoints such as pathological complete response rate, the need for adjuvant radiation~     therapy, use of post operative radiotherapy an the rate of positive margins at surgery.~     Translational endpoints include measuring tumoural and plasma testosterone as well as other~     androgens.~      Patients with untreated high risk and intermediate risk operable prostate cancer will be~     treated with TAK-700 (plus LHRH agonist) for 24 weeks prior to planned prostatectomy.~   "
27195|NCT03211039|"~     This study will seek to determine if rapid genomic sequencing improves outcomes for acutely~     ill infants. The investigator will enroll up to 1,000 acutely ill infants in a prospective,~     randomized, blinded study to either rapid Whole Genome Sequencing (WGS) or rapid Whole Exome~     Sequencing (WES, which is 2% of the genome and ~4-fold less expensive). Outcomes will be~     measured both by objective clinical measures and family perceptions (patient/family centered~     outcomes). Primary analysis of WGS or WES will be in infants alone. Secondary analysis, in~     infants who do not receive a diagnosis, will be of families - ideally trios (mother, father,~     and affected infant), which is ~2-fold more expensive. Trios will be analyzed within the same~     randomization arm (WGS or WES). This study is designed to quantify which acutely ill infants~     benefit from rapid genomic sequencing, by how much they benefit, how they benefit, which~     rapid genomic sequencing method is superior, and the cost effectiveness of such testing.~   "
27196|NCT03211026|"~     The purpose of this study is to better estimate the prevalence of urinary tract infections~     (UTI) in kidney transplant (KIT) recipients, and especially multidrug resistant (MDR)~     bacteria. KIT recipients have a higher risk of UTI over the 6 first months following the~     transplantation. Urine culture was done in a city lab or at hospital. Current data on~     bacteriuria and candiduria lead mostly to hospital data that are incomplete..~   "
27197|NCT03211013|"~     The investigators will test whether intranasal oxytocin (24 IU vs placebo) will induce~     effects on attention bias and startle comparable to those the investigators have shown to be~     induced by the presence (vs absence) of a service dog in Veterans diagnosed with PTSD. This~     possibility is suggested by a 2015 study showing that urinary oxytocin levels are elevated in~     association with mutual gaze between dogs and their owners.~   "
27271|NCT03210038|"~     Women arriving to the Urology department outpatient clinic at Assaf-Harofeh Medical Center in~     order to undergo a cystoscopy examination will be recruited.~      Patients will be randomly assigned to one of four groups by method of cystoscopy (flexible~     and rigid) and by use of anesthesia to the introitus.~      Pain levels will be recorded prior to the examination, during entrance of the cystoscope in~     the urethral meatus, immediately after the examination and 15 minutes after conclusion.~   "
27198|NCT03211000|"~     The molecular mechanisms contributing to the development of aortic aneurysmal disease are~     poorly characterized making actual therapies not sufficient. Autophagy is an intracellular~     mechanism that removes dysfunctional organelles and unfolded proteins, thereby maintaining~     cellular homeostasis. Activation of autophagy was shown to limit cardiac damage during~     stress. Accordingly, autophagy was found to be inhibited in the heart in animal models of~     metabolic syndrome, diabetes, obesity and aging thereby contributing to the development of~     cardiac derangements associated with these conditions. However, it remains to fully dissect~     the association between autophagy and structural alterations of the aortic wall and~     endothelial dysfunction in humans. In this study the correlation between levels of autophagy~     and the development of human aortic aneurysm will be assessed in patients subjected to~     surgical interventions for aortic pathologies. The association of Hippo signaling activation~     with the formation of aortic disease will also be evaluated, since previous work demonstrated~     that the Hippo pathway negatively regulates autophagy and promotes the development of~     cellular abnormalities. The results of this study may provide new insights into the~     mechanisms underlying the development of aortic disease.~   "
27199|NCT03210987|"~     Patient case presentations during ward rounds can take place at the bedside or outside the~     room. The best approach to patient case presentation is yet unclear. Thus, the overall aim of~     this multicenter, randomized-controlled study is to test the hypothesis that outside the room~     patient case presentation compared to bedside patient case presentation results in better~     outcomes across different dimensions including patient understanding and perception of~     quality of care as well as patient outcomes, physicians' preferences, perception of quality~     and effectiveness, and timing of the ward rounds, respectively.~   "
27200|NCT03210974|"~     This study is a non-interventional (NIS), multicenter, retrospective cohort study, which will~     obtain data from patients diagnosed with invasive breast cancer between 2002 and 2005 in the~     medical oncology departments of hospitals that are members of GEICAM (using information~     obtained from patient medical histories).~   "
27201|NCT03210961|"~     This first in human study will evaluate the safety, tolerability, pharmacokinetics (PK), and~     pharmacodynamics (PD) of PF-06826647 in healthy subjects and subjects with plaque psoriasis.~   "
27202|NCT03210948|"~     Diagnostic assessment of solid pancreatic lesions may represent a real challenge in the~     clinical practice, even with the aid of tissue sampling by means of endoscopic ultrasound~     (EUS) fine needle aspiration (FNA).~      Aim of this randomized controlled trial (RCT) is to establish the diagnostic accuracy,~     sensitivity, and specificity of real time elastography (RTE)-guided EUS-FNA as compared to~     conventional EUS-FNA in a series of patients with solid pancreatic masses.~      Eligible will be patients with solid pancreatic masses detected at abdominal imaging~     (ultrasound, CT-scan or MRI).~      In the treatment arm, RTE assessment of pancreatic masses will be performed using a last~     generation ultrasound machine, and all suspicious areas at elastography (i.e. those appearing~     in dark blue color as a consequence of higher cellularity of tumoral tissue) will be recorded~     and stored in our database. A 25 G needle will be then inserted into the most suspicious part~     (dark blue) of the lesion and immediately after the procedure the stylet will be removed.~     At the end of the procedure, the needle will be retracted and the samples will be prepared~     for cytological examination.~      Primary endpoint will be diagnostic yield of the procedure. Secondary endpoints the~     diagnostic sensitivity, specificity, number of passes needed to achieve an adequate sample~     and safety It will be planned to enroll 142 patients (71 per arms) within 1 year. A minimum~     follow up of 6 months from the last patient unsuitable to surgery will be required.~   "
27203|NCT03210935|"~     Merkel cell carcinoma, advanced basal cell carcinoma requiring systemic treatment, and~     cutaneous adnexal carcinomas are 3 types of rare skin cancers for which much remains unknown~     in terms of natural behavior, prognosis, treatment and outcomes.~      CARADERM is a French prospective national cohort enrolling patients with either one of these~     3 tumor types, whose objectives are :~        -  to provide epidemiological, clinical and socio-economic characteristics of patients~        -  to identify new clinical or epidemiological prognostic factors for these rare cancers~        -  to evaluate the impact of various treatments on outcomes~   "
27204|NCT03210922|"~     Effect of semirigid cervical collar during nasotracheal intubation by Glidescope in the~     elective cervical spinal surgical patients: a study of clinical predictors and outcomes~   "
27205|NCT03210909|"~     An intravenous infusion in healthy subjects to obtain information about the absorption,~     metabolism, and excretion (AME) of BMS-986231~   "
27206|NCT03210896|"~     Breath analysis is becoming of increasing interest to researchers throughout the world for~     disease identification and monitoring. It is known that small chemicals dissolved in the~     blood can pass through the blood/air barrier within the lungs and be exhaled in normal~     breath, with many of these chemicals being potential biomarkers for a broad range of~     diseases. These specific biomarkers need to be identified so that gas analysis instruments~     and sensors can be designed to detect these chemicals.~      The aim of this study is to determine if there are biomarkers in exhaled breath that~     correlate with blood glucose concentration. This biomarker can then be used to produce a new~     device that will allow diabetic patients to monitor their blood glucose levels in a quick and~     non-invasive way. The investigators believe this will lead to a significant improvement in~     the quality of life of those suffering from this condition.~      In this study breath samples will be collected using three different methods to maximise the~     chemical information available from each breath. Breath samples from Type 2 diabetic patients~     will be compared with healthy controls. Subgroups will have repeated breath samples after~     drinking orange juice or during normal day-to-day activities. This is to measure any changes~     in breath chemicals over time. The chemicals detected will be compared with blood tests, to~     identify potential breath biomarkers for blood glucose concentration, and to see if factors~     such as sex, age, and diet have any effect on the biomarkers detected.~      This is a single centre pilot study taking place at University Hospitals Coventry and~     Warwickshire NHS Trust, and the analysis of the breath samples will be carried out at the~     University of Warwick. This study is funded by Boydsense, a US company whose mission is to~     change how chronic conditions are detected and monitored, through breath analysis.~   "
27207|NCT03210883|"~     This retrospective multicenter cohort will validate an independent association of~     electrocardiographic (ECG) global electrical heterogeneity (GEH) measures with sustained~     ventricular tachyarrhythmias and appropriate ICD therapies in systolic heart failure patients~     with primary prevention ICD, and will validate and re-calibrate GEH ECG risk score for~     prediction of sustained ventricular tachyarrhythmias and appropriate ICD therapies in~     systolic heart failure patients with primary prevention ICD.~   "
27208|NCT03210870|"~     Purpose of this study is to learn more about how nutritional advice given during pregnancy~     affects a mother's food choices and her baby's growth.~   "
27209|NCT03210857|"~     The aim of this study is to demonstrate the effect of the voluntary neck extension in the~     occurrence of an increase in the pulsatility index of the right internal carotid artery in~     the amateur diver, realizing an apnea of two minutes or more.~   "
27210|NCT03210844|"~     Background The direct anterior approach (DAA) and micro-posterior approach (micro-PA) for~     total hip arthroplasty (THA) become popular approaches due to their fast recovery and good~     clinical outcomes. However, little is known if DAA is superior to micro-PA in implant~     positioning and functional outcomes for THA patients.~      Methods The investigators conducted a non-randomized comparative study to compare component~     positioning and clinical outcomes of the consecutive unilateral primary THA patients operated~     with DAA techniques and that of those operated with micro-PA techniques by a single surgeon.~     The investigators used DAA techniques with standard operation table and micro-PA techniques~     featuring indirect-contracture-releasing capsulotomy, preservation of short external rotators~     except piriformis and conjoint tendon, and tendon-to-bone capsulotendinous repair. The~     investigators used propensity-score matching analysis to compare the postoperative THA~     component positioning and clinical outcomes in DAA and micro-PA groups.~   "
27211|NCT03210831|"~     The goal of this project is to identify neonates who are predisposed to Necrotizing~     Enterocolitis (NEC). the investigators will determine the effectiveness of non-invasive~     measures as well as biochemical markers to identify neonates early in the disease process.~     Thus, the investigators aim to identify infants with NEC prior to the onset of symptoms to~     institute or test treatments in the long term to prevent the progression of the disease in~     these infants.~   "
27212|NCT03210818|"~     Extra-corporeal membrane oxygenation (ECMO) life support system can provide both cardiac and~     respiratory support to patients with heart and respiratory failure. It can save time for~     these patients to regain organ function or to receive transplantation. Both our team and Ince~     et al. from the Netherland found that the microcirculatory dysfunction is more severe in ECMO~     non-survivors. The next step of research is to find out the key factors that affect~     microcirculation in ECMO patients. Because the blood flow supplied by the venoarterial ECMO~     (VA-ECMO) is directly related to macrocirculation, this study aims to investigate the effect~     of adjustment of VA-ECMO blood flow on microcirculation. We hope that the results of this~     study can help the medical team to improve the quality of ECMO care. After evaluation,~     explanation, and acquisition of agreement, the sublingual microcirculation will be examined~     within 24 h and at 48 h after placement of VA-ECMO. The VA-ECMO blood flow will be recorded,~     and the baseline microcirculation will be examined. After the ECMO technician adjusting the~     ECMO flow, sublingual microcirculation will be examined 2 minutes after each adjustment, and~     the change of ECMO blood flow will be recorded. When the ECMO team plans to weaning off the~     ECMO within 72 h, the sublingual microcirculation will be examined. The VA-ECMO blood flow~     will be reduced by ECMO technician, and sublingual microcirculation will be examined 2~     minutes after each adjustment of the blood flow. The ECMO parameters, medications, and~     clinical data will be recorded, and the prognosis will be followed up on the 28th day.~   "
27213|NCT03210805|"~     Investigate the in vivo effects of n-3 PUFA supplementation on inflammation, gene expression~     and epigenetic signatures.~      Ex vivo stimulation of peripheral blood mononuclear cells (PBMCs) collected pre and post n-3~     supplementation and measurement of it's effect on inflammation, gene expression and~     epigenetic signatures.~   "
27214|NCT03210792|"~     A pilot study for a prospective randomized clinical trial was conducted to compare subjects~     using the CCO (Group-A) with those using the ER-splint (Group-B) before and after the~     intervention.~      The primary outcome was difference in the level of pain based on the visual analogue scale~     (VAS) between before and after intervention in each group during forceful and resting~     respiration.~      VAS : Visual analogue scale CCO : Chrisofix® Chest Orthosis~   "
27215|NCT03210779|"~     This research will study the healing of standardized wounds created in the oral mucosa of~     volunteer participants during daily intake of tablets and topical application of oil~     containing the probiotic bacterium Lactobacillus reuteri. Our null hypothesis is that the~     consumption and topical application of probiotic supplements containing L. reuteri does not~     improve clinical healing of oral wounds in healthy participants when compared to controls.~   "
27216|NCT03210766|"~     The aim of this study is to evaluate the efficacy of oral administration of nabilone or~     THC/CBD administration in combination with spinal cord stimulation (SCS) in FBSS patients~     refractory to other available therapeutic strategies.~   "
27217|NCT03210753|"~     Background and objective~      The introduction of a proteasome inhibitor bortezomib has significantly improved response~     rates and overall survival in patients with multiple myeloma (MM), and it has soon become the~     cornerstone of treatment in both newly diagnosed and relapsed/refractory settings. However,~     the incidence of peripheral neuropathy related to bortezomib (BiPN) is unignorable and which~     becomes an obstacle during treatment with bortezomib, either alone or in combination. Until~     now, there are no consistent findings regarding the risk factors that may cause BiPN. There~     is either lack of large scale study of BiPN in Taiwan. This study aims to clarify risk~     factors of BiPN using retrospective analysis in a large cohort with longer observation period~     as well as the relations between BiPN and gene polymorphisms, and to compare different routes~     in the incidence of BiPN.~      Methods~      This is a retrospective cohort study with a sample size of about 400 MM patients treated ever~     with at least one full cycle of bortezomib in the institution. All the patients enrolled need~     to be adults (≧20 years ) with measurable M-component in either blood or urine. The~     investigators will perform a retrospective chart review to collect clinical data, including~     anti-MM and concomitant medications, to evaluate the incidence and severity of BiPN in this~     cohort, as well as any meaningful risk factors contributed to BiPN. The investigators also~     plan to perform genotyping for the possible genetic factors associated with development of~     BiPN.~      Expected contributions~      The successful collaboration between clinical hematologist-oncologist and biopharmaceutical~     researcher would result in the concrete evidence of efficacy and safety of bortezomib in~     Taiwanese patients with MM. The findings in this large cohort study will unveil the risk~     factors of BiPN, including the administration routes and ethnicity. As results, the~     investigators would be able to provide the precision medicine-based bortezomib treatment~     strategy to MM patients in Taiwan.~   "
27218|NCT03210740|"~     To compare the safety and efficacy profiles of AM001 Cream, 7.5% and its vehicle cream in the~     treatment of Actinic Keratosis (AK) Lesions~   "
27219|NCT03210727|"~     The investigators will use a single arm design and deliver a new supportive intervention~     entitled, Ready to Connect, Actively Relax and Exercise (CARE). The purpose of the study is~     to describe the feasibility, acceptability, and potential effectiveness of the Ready to CARE~     intervention. Effectiveness outcomes include caregiver self-efficacy, distress, and coping~     style, and patient quality of life, symptom burden, and healthcare utilization.~   "
27220|NCT03210714|"~     This phase II Pediatric MATCH trial studies how well erdafitinib works in treating patients~     with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders that have spread to other~     places in the body and have come back or do not respond to treatment with FGFR mutations.~     Erdafitinib may stop the growth of cancer cells by blocking some of the enzymes needed for~     cell growth.~   "
27221|NCT03210701|"~     An estimated 21% of Canadians with HIV are unaware of their infection. There is a need to~     improve access to HIV testing to detect infections earlier so individuals can access care~     early and take steps to prevent transmission to others. Barriers to HIV testing include~     limited access or reluctance to go to traditional testing sites (doctor's offices and~     sexually transmitted infection clinics), and the lengthy wait time to receive test results~     from standard laboratory-based HIV testing (usually 1-2 weeks). These deterrents are~     particularly significant for those at highest risk of infection, who may be socially~     marginalized or stigmatized. In rural areas, HIV testing may only be available through~     doctor's offices and hospitals, yet many Canadians do not have access to a family physician.~     Pharmacists are among the most trusted and accessible healthcare providers, and are well~     positioned to improve access to HIV testing. Point of care tests for HIV are easy to~     administer and results are available within minutes, making them ideal for use in the~     community pharmacy setting. Point of care testing (POCT) by pharmacists can ensure~     individuals receive their test results, and facilitate timely linkages to care and treatment.~     This adaptation grant will look at factors influencing the acceptability and feasibility of~     pharmacist-provided rapid POCT for HIV in two Canadian provinces, including pharmacies in~     both urban and rural areas. The effectiveness of pharmacist-delivered POCT will be considered~     from a variety of perspectives including people living with or at risk of HIV, as well as~     pharmacists as the service providers.~   "
27222|NCT03210688|"~     Traditionally MCN is treated with a high dose of prednisolone, which induces remission in~     60-90% of patients. Prednisolone treatment contains numerous side effects and the current~     dose is empiric. Given the lack of efficacy evidence and the risk associated with the~     currently accepted treatment regimen there is a need to characterize the outcome in MCN~     further, and to establish new, and potentially less toxic treatment regimens.~      The aim is to examine if treatment with reduced dose of prednisolone in combination with~     activated vitamin D is as effective as standard high dose prednisolone in achieving remission~     and preventing relapse in MCN, and if reduced dose prednisolone is associated with fewer side~     effects compared to standard dose. Furthermore, the study will examine the influence of~     prednisolone metabolism on the efficacy and side effects of prednisolone in the treatment of~     MCN.~   "
27223|NCT03210675|"~     Interventional, comparative, open label, single-center study to demonstrate that an early~     (from 6 months of age) and systematic (every 6 months) screening of Obstructive Sleep Apnea~     (OSA) by polysomnography (PSG) in children with Down Syndrome during the first 3 years of~     life is associated with an improved neurocognitive development at the age of 3 years.~   "
27224|NCT03210662|"~     The goal of this clinical research study is to learn if the combination of external beam~     radiation therapy (EBRT) and pembrolizumab can help control relapsed (has come back) and~     refractory (has not responded to treatment) non-Hodgkin's Lymphoma (NHL). The safety of this~     combination will also be studied.~      This is an investigational study. Pembrolizumab is FDA approved and commercially approved for~     many types of cancer, including classical Hodgkin Lymphoma. EBRT will be performed using FDA~     approved and commercially available methods. The combination of EBRT with Pembrolizumab to~     treat NHL is investigational.~      The study doctor can describe how the study drug and radiation therapy combination are~     designed to work.~      Up to 70 patients will take part in this study. All will be enrolled at MD Anderson.~   "
27225|NCT03210649|"~     The purpose of this study is to investigate the safety/tolerability and~     pharmacokinetics/pharmacodynamics of CKD-519~   "
27226|NCT03210636|"~     In order to help the surgeons to clearly visualize their target operating area and create an~     optimal operative field throughout the procedure, the device owners have developed a new~     class of inflatable laparoscopic retractors for both bowel and organ specific retraction with~     load bearing bore by an inflatable reinforced material that is atraumatic, biocompatible, and~     are self-retained, i.e. require no personnel to maintain them post-placement.~      Specifically, the device owners menu of designs hold a range of 50 - 100 % of the bowels and~     support at minimum 6 lbs in the vertical direction. All the device owners devices enter the~     abdominal cavity through a conventional 10mm incision. The pressure within the inflatable~     tubes of the device will not be above 15 mmHg, which is the current pressure used to~     insufflate the patient's abdomen with carbon dioxide (CO2). The devices are able to retract~     up to 10 cm of the bowels in any direction within the coronal plane and retract the bowels~     10cm upward, towards the abdominal wall. Finally, the invention here-in described can be~     manipulated easily to provide retraction of specific organs, including, liver, bladder,~     uterus, etc.~      The device has been approved by the FDA for clinical use (FDA Registered) and the purpose of~     this study is to evaluate the device in laparoscopic operations for safety and feasibility.~   "
27227|NCT03210623|"~     The study is a prospective, multi-center, stratified randomized, single-blind, parallel~     assignment, active control, non-inferiority trial. Patients are randomized 1 : 1 to either~     stent retriever(TonbridgeMT) or Solitaire™ for endovascular therapy for AIS. The study aims~     to evaluate the benefit and safety of stent retriever(TonbridgeMT) for AIS therapy, as~     compared to Solitaire™.~   "
27228|NCT03210610|"~     in this study the investigators will measure the colchicine trough levels in 80 FMF patients~     taking stable doses of colchicine~   "
27229|NCT03210597|"~     The objective of the present study was to compare the neuromuscular, cardiorespiratory and~     metabolic effects of 12 weeks of aerobic training, strength training and combined training in~     the aquatic environment in women with MS. For this purpose, 51 postmenopausal, sedentary and~     MS women were randomly divided into three intervention groups: hydro-aerobic (HA, n = 18,~     63.77 ± 5.03 years), hydro-power (HF, n = 16, 61.01 ± 4.93 years) and hydro-combined (HC; n =~     17; 60.52 ± 6.91). A subsample participated in eight weeks without physical exercise to~     characterize a control period. The three intervention groups performed two weekly sessions of~     60 minutes for 12 weeks. Before and after the training period, blood tests, muscle strength~     tests, cardiorespiratory evaluation, functional tests and a questionnaire were performed. For~     statistical analysis, the Generalized Estimates Equations (GEE) model was used, using the~     group and the time as factors. The Bonferroni post hoc was used to locate the differences~     and the significance index adopted was α = 0.05.~   "
27230|NCT03210584|"~     Evaluation and comparison of histological analysis, 9,4 tesla MRI, Full-Field Optical~     Coherence Tomography (FFOCT) and ultrasound-based navigation system for cartilage~     degeneration analysis of patellofemoral joint.~   "
27232|NCT03210558|"~     Trial objectives and purpose: The primary aim is to study the effects of moderately increased~     testosterone concentration on aerobic performance (endurance time to exhaustion), and~     secondary aims to investigate the effects on submaximal work on treadmill, muscle strength,~     body composition, behaviour and well-being, blood parameters, steroid hormone profile,~     gynecological parameters and skeletal muscle parameters in young healthy women in a~     double-blind, randomized, placebo-controlled trial.~      Treatment: Ten weeks of transdermal treatment with testosterone cream 10 mg daily or placebo~     cream in a randomized design (1:1).~      Primary outcome: Aerobic performance (endurance time to exhaustion)~      Secondary outcomes:~        1. Submaximal work on treadmill (oxygen uptake, ventilation, heart rate, blood lactate and~          subjective rate of exhaustion)~        2. Muscle strength (Cybex apparatus, force transducer, counter movement jump)~        3. Body composition (Dual X-ray Absorptiometry: muscle mass, fat mass, bone mass)~        4. Behaviour and well-being (Quality of life, Profile of mood state, Confidence~          Questionnaire, Aggression Questionnaire)~        5. Blood parameters (hemoglobin, hematocrit, reticulocytes, ferritin, CRP)~        6. Steroid hormone profile in blood and urine~        7. Gynecological evaluation (ovarian and endometrial variables on ultrasound)~        8. Skeletal muscle morphology, metabolic enzymes and muscle protein synthesis~      Study population: Fifty healthy menstruating women will be included in the study and~     randomized to treatment with testosterone or placebo. Inclusion criteria: 18-35 yrs of age;~     body mass index (BMI) 19-25; non-smoking; a moderate to high self-reported level of~     recreational physical activity; not taking hormonal contraception and willing to use highly~     efficient non-hormonal contraception during the study (intrauterine device, bilateral tubal~     occlusion, vasectomised partner, same-sex partner, or sexual abstinence); accepting to not~     participate in any sports competitive event during the study period plus one month. Exclusion~     criteria: the presence of cardiovascular, liver, biliary or renal disease; hyperlipidemia;~     uncontrolled high blood pressure; endocrinological disorder; oligomenorrhea (menstrual~     intervals of more than 6 weeks) or amenorrhea (no menstruation for at least 3 months);~     pregnancy; a history of thromboembolic disorder; any malignancy; and intake of hormonal~     contraception the last two months prior to the study.~   "
27233|NCT03210545|"~     DOSCORT is a 2-dose, cross-over study primarily aiming to identify and validate novel~     biological markers (biomarkers) of glucocorticoid effect in the human body. Patients with~     Addison´s disease, primary adrenal insufficiency, with life-long glucocorticoid replacement~     therapy will undergo 2 treatment periods where their usual hydrocortisone treatment will be~     replaced with dexamethasone in physiological and supra physiological doses. Blood, saliva,~     urine, health related Quality-of-life self-assessment forms, measurements of physical~     activity and sleep quality will be collected from both treatment periods.~   "
27234|NCT03210532|"~     A Multicenter, Randomized, Double-blinded, Double-dummy, Phase 3 Clinical Trial to Evaluate~     the Efficacy and Safety of Combination Treatment with DW1501-R1+DW1501-R2 Versus DW1501-R1 or~     DW1501-R2+DW1501-R3 in Patients with Hypertension and Dyslipidemia~   "
27235|NCT03210519|"~     This is a randomized, double-blind, placebo-controlled, parallel comparison trial to evaluate~     the efficacy and safety of Eleutherococcus Senticosus taken orally by patients under regular~     dialysis. Eligible subjects with written consent were randomized into one of the two groups:~     A. Acanthopanax senticosus (30mg/vial); B. Placebo. After 2-4 weeks of run-in period, the~     study subjects were asked to take the investigational products orally for 90 days in order to~     evaluate the effects of oral Eleutherococcus Senticosus liquid on the markers of~     inflammation, anemia, and safety, and to compare the efficacy among oral Acanthopanax~     senticosus and placebo.~   "
27236|NCT03210506|"~     Pegylated interferon α-2a(Peg-IFN-α) not only inhibit viral replication, but also play an~     important role in immune regulation, while Nucleoside analog(ue) drugs only inhibit viral~     replication. In hepatitis B infection, cytokines played a vital role. This study was aimed at~     investigating the changes of cytokines during Peg-IFN-αand nucleoside analog(ue)~     therapy.Meanwhile, the investigators wanted to verify whether Peg-IFN-α therapy resulted in~     the secretion of cytokines.~   "
27237|NCT03210493|"~     Pegylated interferon α-2a(Peg-IFN-α) not only inhibit viral replication, but also play an~     important role in immune regulation, while Nucleoside analog(ue) drugs only inhibit viral~     replication. In hepatitis B infection, Treg cells Regulatory T cells played a negative role~     in immune. This study was aimed at investigating the changes of Treg cells frequency and~     function, and the expression of costimulatory molecules during Peg-IFN-αand nucleoside~     analog(ue) therapy.Meanwhile, the investigators wanted to verify whether Peg-IFN-α suppressed~     the virus, which led to the decline of Treg cells frequency and function;negative regulation~     of Tregs for immune cells diminished, hence, the function of immune cells recovered.~   "
27238|NCT03210480|"~     The aim of the study is to assess the tolerability, efficacy and safety of a new lithium~     sulphate prolonged release formulation (Lithiofor®) in patients affected by Bipolar Disorder~     poor tolerant to lithium immediate-release treatment in terms of lithium-induced tremor when~     switched from therapy with a lithium carbonate immediate release formulation (Carbolithium®)~     to a new lithium sulphate prolonged release formulation (Lithiofor®).~   "
27239|NCT03210467|"~     Pegylated interferon(IFN) α-2a(Peg-IFN-α) not only inhibit viral replication, but also play~     an important role in immune regulation, while entecavir(ETV) drugs only inhibit viral~     replication. In hepatitis B infection, Plasmacytoid Dendritic Cells（pDCs） are the main~     effector cells in early antiviral innate immune response. This study was aimed at~     investigating the changes of pDCs frequency and function, and the expression of costimulatory~     molecules CD86(Cluster of Differentiation antigen 86) during Peg-IFN-αand entecavir(ETV)~     therapy.Meanwhile, investigators want to verify whether Peg-IFN-α suppressed the virus and~     the reduction of virus led to the recovery of pDCs function, or Peg-IFN-α enhanced pDCs~     function which gave rise to the decline of the virus.~   "
27240|NCT03210454|"~     The proposed project seeks to implement a cluster-randomized controlled trial (RCT) to~     measure the impact of increasing women´s incomes and providing gender equality trainings on~     women´s empowerment and risk of intimate partner violence (IPV) in Colombia. This project~     will be the first in Latin America to evaluate rigorously the impact of a marketing~     intervention, alone and combined with IPV prevention training. The knowledge generated from~     this evaluation has the potential to identify the most effective solutions to empower women,~     as well as to drive transformative change in current approaches to reduce IPV and promote~     gender equality in highly vulnerable populations in Colombia, and worldwide.~   "
27272|NCT03210025|"~     The objective of the study is to compare the bioavailability of a generic product of~     methyldopa with that of a reference product when administered to healthy volunteers under~     fasting condition. The test product is BF-Methyldopa Tablet 250mg (HK Reg. No. HK-62917)~     manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical~     Laboratories Limited, and the reference product is Metopa Tab 250mg (HK Reg. No. HK-44620).~     The plasma pharmacokinetic data of Methyldopa obtained from two formulations will be used to~     access the interchangeability of the products.~   "
27241|NCT03210441|"~     In post-menopause women affected by breast cancer and treated with chemotherapy, overweight~     and obesity are considered both a risk factors as well as a negative prognostic factors since~     they increase the risk of early relapse and death. Furthermore, a decrease in weight may also~     occur during chemotherapy and is associated to a reduced quality of life and survival. Also,~     the majority of patients under chemotherapy refer dysgeusia, an alteration in taste that can~     determine food aversion, selection of hypercaloric food or reduced food introduction up to~     malnutrition. Our aim is to evaluate eating habits changes in patients affected by breast~     cancer and under chemotherapy treatment and to better understand how this alterations~     influence the quality of life, anxiety, depression and insomnia of patients as well as~     overall survival.~   "
27242|NCT03210428|"~     Hypoxic tumour cells within the primary tumour have shown prognostic importance for local and~     metastatic disease control in several cancer sites. Radioresistant hypoxic cells diminish the~     rate of local control, and the hypoxia driven increase in metastatic potential of the tumour~     and lowers the rate of distant disease control. DCE MR imaging has been used to quantify the~     extent of poor perfusion regions within cervical tumours and it has been shown to be a~     surrogate of hypoxia. Furthermore, a number of studies have demonstrated that DCE MR is~     predictive of disease failure in cervix cancer.~      The EMBRACE II study will implement an imaging sub-study, which will evaluate the value of~     quantitative MR imaging to identify patients at increased risk of disease recurrence (local,~     nodal and systemic).~   "
27243|NCT03210415|"~     In China, there's no effective prevention and treatment on preterm birth for pregnant women~     ≥35 years old, so this study is necessary.~   "
27244|NCT03210402|"~     New therapy tested in heart failure with preserved ejection fraction (HFpEF) patients with~     approved indications for pacing to determine if elevated pacing therapy is tolerated and~     whether there is a signal for efficacy.~   "
27245|NCT03210389|"~     The purpose of this study is to evaluate the efficacy and safety of chemotherapy with~     Lobaplatin and 5-FU, in Recurrent Local or Distant Advanced Nasopharyngeal Carcinoma.~   "
27246|NCT03210376|"~     Insufflation pressure (IP) is the creation of a pressure barrier of air/gas within the~     abdomen to allow the surgeon more space to work during abdominal surgery. Shoulder pain is a~     common complaint from patients who have had abdominal surgery and the pain is thought to be~     related to the use of IP.~      In addition to anesthesia (which keeps you asleep during surgery), the current standard~     practice is to block the nerve-muscle junction with a type of drug called neuromuscular~     blockade (NMB) which paralyzes the abdominal muscles. This means that a lower level of~     insufflation pressure is needed by the surgeon.~      To reverse the effects of NMB after surgery, a drug called neostigmine is given.~      The goal of this clinical research study is to compare the use of standard-of-care moderate~     NMB and neostigmine to the use of deep NMB and a drug called Sugammadex when given to elderly~     patients (patients who are 65 years of age or older) who are scheduled to have robotic~     abdominal surgery. Deep and moderate in this study refers to the dose or strength of the~     NMB given.~      This is an investigational study. Sugammadex and neostigmine are FDA approved and~     commercially available for the reversal of NMB. It is considered investigational to compare~     Sugammadex and neostigmine to learn if the use of one or the other in elderly patients can~     reduce the level of shoulder pain after surgery.~      Up to 100 participants will be enrolled in this study. All will take part at MD Anderson.~   "
27247|NCT03210363|"~     Dengue is an important public health problem despite the efforts of local health authorities~     to mitigate the impact of epidemics and the epidemiology of dengue evolved from an~     endemo-epidemic to a hyper-endemic state. In late 2013, the first local transmission of~     chikungunya virus in the Americas was identified in Caribbean countries and territories~     including French Guiana. Rapidly, more than 16,000 suspected local Health authorities had~     reported cases. In May 2015, the Pan American Health Organization (PAHO) issued an alert~     regarding the first confirmed Zika virus infections in Brazil. The emergence of Zika virus in~     South America led to a rapid spread throughout South and Central America, reaching French~     Guiana in December 2015. With the increasing frequency of epidemics related to arbovirus and~     the resulting health, social, and economic impacts of dengue, the surveillance of arbovirus~     have become social, political, and public health challenges that require specific and~     non-available immune status information.~   "
27248|NCT03210350|"~     It had been shown that high percentage of severe preeclampsia patients got a high cerebral~     perfusion pressure (CPP) due to abnormal autoregulation of cerebral blood vessels with~     associated endothelial dysfunction and disrupted blood brain barrier. Moreover, patients with~     high CPP is more likely to present with headache compared to other patients with normal~     CPP.In this particular scenario, use of magnesium sulphate is associated with marked~     reduction of CPP and. hence prevention of cerebral damage.This hypothesis was confirmed by~     new magnetic resonance techniques that demonstrated brain edema in eclampsia/ severe~     preeclampsia patient mostly due to vasogenic edema and less commonly attributed to cytotoxic~     edema.~      Changes in the optic nerve sheath diameter (ONSD) mirrors the changes in the Intracranial~     pressure(ICP), subsequently when the intracranial pressure increases the optic nerve sheath~     diameter (ONDS) also increases.~      The aim of this study is to determine the effect Magnesium sulphate infusion on intracranial~     pressure, in patients presented with severe preeclampsia by measuring changes in the ONSD~     using ultrasound examination.~   "
27249|NCT03210337|"~     The primary objective of this study is to evaluate the effectiveness of A-101 compared to~     vehicle when applied to 1 common target wart on the trunk or extremities.~   "
27250|NCT03210324|"~     To investigate the efficacy and adverse effects of mifepristone tablets in widely used~     conditions, to evaluate the relationship between interests and risks used in general or~     special populations, to further observe the safety and efficacy of drugs.~   "
27273|NCT03210012|"~     This is a monocentric pilot study to assess the safety profile of a 30-meter deep underwater~     diving using 3 different type of gas mixtures: AIR (21% O2 and 79% N2), NITROX 32 (32% O2 And~     68% N2) and TRIMIX (21% O2, 44% N2 and 35% He).~   "
27481|NCT03207282|"~     The purpose of this study is to estimate the prevalence of Treatment Resistant Depression~     (TRD) among Major Depressive Disorder (MDD) participants being treated in a psychiatry~     reference site (example, clinic, ambulatory, hospital, day-hospital) in 4 Latin American~     countries: Argentina, Brazil, Colombia and Mexico; and to evaluate all and depression-related~     healthcare resource utilization in TRD participants.~   "
27251|NCT03210311|"~     Breast-cancer related lymphoedema (BCRL) is a common phenomenon. Early diagnosis and~     treatment is very important to alter the normal progression of this disease. A threshold (>=~     3% volume change) that recognizes subclinical lymphedema is promoted. When the lymphedema is~     diagnosed late, options for treatment are diminished as fibrous tissue is formed.~      Preoperative investigation with near-infrared fluorescence lymphography can show an~     abnormality. Even if a linear transport is visualized, velocity of the transport can be~     diminished or a different pathway than normal can be visualized. Such an extensive evaluation~     has not been performed yet.~      This lymphofluoroscopy gives an opportunity to detect lymphedema earlier than clinically~     visible (subclinical). The investigators hypothesize that the evolution of lymphedema can be~     altered if treatment is started in the subclinical phase.~   "
27252|NCT03210298|"~     Multicentric, international, web-based prospective documentation of the indications and~     results of Pressurized Aerosol Chemotherapy (so-called PIPAC or PITAC) for treating malignant~     pleural and peritoneal diseases. Indication is decided by the treating physician. There are~     no predefined inclusion or exclusion criteria.~   "
27253|NCT03210285|"~     Whole exome sequencing (WES) of 50 sporadic and 50 Neurofibromatosis Type2 (NF2)-associated~     vestibularis schwannomas (VS) in children and young adults. The aim is to gain insight into~     the complete genome of the NF2 associated VS compared to sporadic VS (control group). These~     data are to be correlated with the clinic, ie the auditory function (audiogram, acoustically~     evoked potentials) and the clinical picture as well as the tumor growth rate and general data~     such as sex, age, side, etc.~   "
27254|NCT03210272|"~     The primary objective of this trial is to investigate the safety and tolerability of BI~     1358894 in healthy male subjects following oral administration of single rising doses.~     Secondary objectives are the exploration of the pharmacokinetics (PK), including dose~     proportionality of BI 1358894 after single dosing.~   "
27255|NCT03210259|"~     The primary objective of the trial is to assess the PK similarity between patients receiving~     Humira® continuously vs those who alternate between BI 695501 and Humira®, in patients with~     moderate-to-severe chronic plaque psoriasis.~      The secondary objectives of this trial are to descriptively compare the safety,~     immunogenicity and efficacy profiles between patients receiving Humira® continuously vs those~     who alternate between BI 695501 and Humira®.~   "
27256|NCT03210246|"~     This study will be performed as a multi-center, randomized, double-blind study in 60 healthy~     women (2 groups of 30 women) to investigate ovarian activity during simultaneous intake of a~     COC (containing the estrogen EE and the progestin LNG) and the progesterone receptor~     modulator (PRM) vilaprisan.~   "
27257|NCT03210233|"~     Teicoplanin is an antibiotic used very commonly to prevent infection during surgery. Its use~     has expanded rapidly in the last few years, with around 18,500 doses administered in Leeds~     Teaching Hospitals NHS Trust alone, in 2014-15. Unfortunately, anaphylaxis (a severe allergic~     reaction) to the drug appears to be increasing. These reactions can result in admission to~     intensive care, prolong hospital stay, or even be fatal.~      It is vital that patients who suffer anaphylaxis have tests to accurately identify the cause,~     so they can avoid the drug in future. However these tests are currently very limited, because~     we don't have any diagnostic tools proven to confirm or refute a diagnosis of teicoplanin~     allergy. We have to make a 'best guess' diagnosis, leaving patients vulnerable to harm in the~     future, should they require antibiotics again. We need to reliably diagnose teicoplanin~     allergy to reduce this arm. Where a diagnosis of teicoplanin allergy is confirmed, patients~     and their doctors know to avoid it. Importantly, where allergy is excluded, teicoplanin can~     be safely used, avoiding alternatives that may be less effective, more toxic, and more~     expensive. This directly benefits individuals, saves the NHS money by reducing avoidable~     harm, and helps improve antibiotic stewardship at a population level - which in the long term~     helps reduce antibiotic resistance. The clinical need for this work has become imperative.~      Collaborating with our industry partner ThermoFisher (significant expertise in this area), we~     aim to:~        1. Standardise the current skin testing protocols being used when testing patients with~          suspected teicoplanin allergy.~        2. Develop laboratory tests to support the skin tests, and give a more confident diagnosis~          to patients.~        3. Understand how and why people develop allergy to teicoplanin, to better predict and~          modify the allergic response.~   "
27258|NCT03210220|"~     In this study, the investigators will compare the intraoperative opioid The purpose of this~     study is to determine whether pectoral nerves blocks（PECS） would reduces the opioid~     consumption during the surgery and postoperative pain after breast cancer surgery.~   "
27259|NCT03210207|"~     Between January and December 2012, a total of 40 patients underwent GLP. The study will~     assess subject excess weight loss (%EWL) following the study procedure at 3, 6, 12, 36 and 60~     months.~   "
27260|NCT03210194|"~     Background: About 10% of all newborns may have difficulty breathing and require support by~     trained personnel. In Peru, 90% of deliveries occur in health facilities; however there is~     not a national neonatal resuscitation and certification program for the public health sector.~     In addition, the Andes and the Amazon regions concentrate large rural remote areas, which~     further limit the implementation of training programs and the accomplishment of continuous~     certification. Neonatal resuscitation training through the use of information, communication~     and technology (ICT) tools running on a computer, tablet or mobile phone may overcome such~     limitations. This strategy allows online and offline access to educational resources, paving~     the way to more frequent and efficient training and certification processes.~      Objective: To evaluate the effects of a neonatal resuscitation training and certification~     program that uses a multi-platform ICT (MP-ICT) strategy on neonatal health care in remote~     areas.~      Methods: The investigators propose to conduct the study through a cluster-randomized trial,~     where the study and analysis units are the health care facility. Eligible facilities will~     include primary and secondary health care level facilities that are located in provinces with~     neonatal mortality rates higher than 15 per 1,000 live births. The investigators will compare~     the proportion of newborns with a heart rate ≥100 beats per minute at 2 minutes after birth~     in health care facilities that receive MP-ICT training and certification implementation, with~     those that receive conventional training and certification.~      Discussion: The investigators expect that the intervention show to be more effective than the~     current standard of care. The investigators are prepared to include it within a national~     neonatal resuscitation training and certification program to be implemented at national scale~     together with policymakers and other key stakeholders.~   "
27261|NCT03210181|"~     Myofascial pain is an important cause of neck pain or neck and shoulder pain. Neck shoulder~     pain is a common socioeconomic problem that negatively affects the quality of life. Different~     treatment strategies with limited effectiveness or application have been implemented.~     However, medication remains a widely used approach.~      The levator scapulae is one of the muscles involved in myofascial pain leading to levator~     scapulae syndrome. The muscle limits the rotation of the neck. It is innervated by branches~     of the third and fourth cervical nerves through the cervical plexus. Hence, performing~     superficial cervical plexus block may have some potential effect in reducing myofascial pain.~   "
27262|NCT03210168|"~     This study evaluates the safety, tolerability, and activity of BioFe in the dietary~     management of iron deficiency in adults.~   "
27298|NCT03209687|"~     The aim of this study is to test the hypothesis that addition of daily small dose of human~     menopausal gonadotropin (HMG) drug following oocytes retrieval could improve the fertility~     outcome in women undergoing in-vitro fertilization~   "
27263|NCT03210155|"~     The birth of a child is a major life event that can be filled with excitement, anticipation~     and joy. However, the transition and adaptation to new demands, roles, responsibilities, and~     changes in relationships can be stressful, especially for new mothers. In addition, new~     mothers typically encounter physiological changes and struggle with concerns about weight~     gain, body image, sexuality, and other physical difficulties such as fatigue. These problems~     may generate or exacerbate stress, lead to an actual or perceived crisis and psychological~     distress.~      Psychological distress, defined as anxiety, depression, and insomnia, in this study, often~     increases during the postpartum period and can negatively affect maternal mental health~     status, maternal and family relationships, and infant-child health. The purpose of this study~     is to evaluate the effects of cranial electrotherapy stimulation (CES) on anxiety, insomnia,~     depression, and maternal functioning in first time new mothers following childbirth.~   "
27264|NCT03210142|"~     The purpose of this study is to assess the effect of Transvenous Hypoglossal Nerve~     Stimulation (tHGNS) on tongue position in the upper airway. Activation of the HGN will cause~     contraction of the genioglossus muscle, which will move the tongue forward, opening the~     upper-airway and reducing apnea-hypopnea events in patients with Obstructive Sleep Apnea~     (OSA). A transvenous approach will be less risky and traumatic than current HGNS systems that~     require an open surgical approach to wrap a cuff electrode around the HGN.~   "
27265|NCT03210129|"~     Physical activity is not only efficient for primary prevention of several cancer types, but~     it also plays an important role in cancer survivors. Physical activity after a cancer~     diagnosis has been associated with reduced overall and cancer-specific mortality. It has~     significant positive effects on physical fitness and several cancer-related symptoms~     including fatigue, sleep disturbance, depression and anxiety. The evidence is considerable~     and consistent for breast, colorectal and endometrial cancers. However, patients are~     generally insufficiently active, and participation rates in physical activity opportunities~     offered by specialized organizations are low. This pilot study will evaluate the feasibility,~     efficacy and cost-effectiveness of an intervention seeking to increase active lifestyle and~     physical activity participation of cancer patients. To encourage this behavioural change,~     motivational interviewing will be used, a patient-centred approach aimed at increasing the~     patients' motivation for a behavioural change through open-ended discussions.~      Seventy patients with breast, colorectal or endometrial cancer will be recruited within a~     time period of 12 months. Patients will be randomly assigned to an intervention or a control~     group. The intervention group will receive standard care alongside 12 motivational~     interviewing sessions within 12 weeks. The control group will receive standard care only.~     Physical activity behaviour (3D-accelerometer) and physical fitness (cardiovascular and~     strength fitness) will be measured in the week preceding and following the intervention.~     Additionally, a subgroup from both study arms will be assessed 12 weeks after the completion~     of the intervention. The investigators hypothesize that sedentary time will decrease and time~     spent in moderate and vigorous physical activity, physical fitness and quality of life of~     cancer survivors will increase to a greater extent in the intervention group than in the~     control group. Furthermore, health-related quality of life and resource use (intervention and~     healthcare costs, out of pocket costs) will be measured to evaluate the cost-effectiveness of~     the intervention.~   "
27266|NCT03210103|"~     The goal of this randomized treatment de-escalation study is to formally compare outcomes in~     HPV related oropharyngeal cancer tumors treated with a primary radiotherapy versus a primary~     surgical approach, to provide a high level of evidence to guide the selection of treatment~     options for a subsequent phase III trial~   "
27267|NCT03210090|"~     Donor and recipient CMV-serostatus is one of the risk factor for CMV infection in solid organ~     transplantation. Recipients with IgG positive anti-CMV are classified as low-risk patients~     since it is considered that patients also have specific cellular immunity against CMV.~     However, investigators group has published that around 25% of solid organ transplant~     candidates lack CMV-specific CD8+ T-cell response (humoral/cellular mismatch) and they are~     at a higher risk of CMV replication after transplantation. The main goal of this study is to~     analyze the impact of the humoral/cellular mismatch in hematopoietic stem cell~     transplantation (HSCT) CMV-seropositive donors on the CMV reactivation after HSCT in~     CMVseropositive recipients. Investigators will study not only the incidence of CMV~     reactivation but also the severity (duration and peak viral load), CMV disease and survival.~     CMV-seropositive patients who receive a HSCT (bone marrow or peripheral blood) from related~     donors will be consecutively recruited from Reina Sofía Hospital (Córdoba) and Marqués de~     Valdecilla Hospital (Santander).~      Patients will be monitored during 12 months after HSCT. CMV-specific CD8+ T-cell response~     will be determined in their donors, using QuantiFERON-CMV assay, to know the frequency of~     humoral/cellular mismatch. Innate and adaptive immune reconstitution will be assessed by flow~     cytometry and experimental QuantiFERON Monitor assay. CMV-specific CD8+ T-cell reconstitution~     will be determined using QuantiFERON-CMV assay.~   "
27268|NCT03210077|"~     The critically ill patient is one of the most complex cases with regard to the optimization~     of the anesthesia, as well as postoperative management. One of the most important steps in~     the complex management of such patients is the modulation of anesthesia for every patient~     needs. We start with the assumptions that the optimization of anesthesia should depend on~     each patient, being conducted in an individual manner. We also believe that by~     individualizing the anesthesia by monitoring the entropy it is possible to obtain an~     appropriate management regarding hemodynamic complications during anesthesia including~     tachycardia, bradycardia, hypotension and hypertension.~   "
27269|NCT03210064|"~     This study makes an observation over the objective response rate of Apatinib and 5-Fu~     combination regimen in the three-line treatment of metastatic colorectal cancer. All the~     participants will randomly receive the treatment of Apatinib and 5-Fu combination regimen or~     5-Fu.~   "
27270|NCT03210051|"~     Currently, early reperfusion is considered as the most effective therapy for the treatment of~     acute ischemic stroke (AIS). Over the past 20 years, intravenous tissue plasminogen activator~     (IV tPA) has been demonstrated to be the only effective therapy for AIS. More recently,~     several large randomized clinical trials have concluded the superiority of endovascular~     mechanical thrombectomy for AIS. Furthermore, with the development of materials and~     techniques, the occluded artery can be recanalized with high percentage (60%-90%), and the~     rate of recanalization is still being improved. A great number of AIS patients are now~     eligible for revascularization therapy and there should be a good prognosis of AIS after~     recanalizing the occluded artery using mechanical thrombectomy. However, things are never as~     simple as wished to be. The rate of patients with functional independence is less than 50%~     and over 15% patients died at 3 months post thrombectomy. The discrepancy between the~     functional outcome and recanalization rates encourage researchers to explore strategies that~     further improving the functional outcome of AIS patients.~      Remote ischemic conditioning has been demonstrated to reduce cerebral infarct size in mouse~     model of focal cerebral ischemia. And clinical researches demonstrated the protective effects~     of remote ischemic conditioning in AIS patient treated with IV tPA,. However, whether remote~     ischemic conditioning is safe and effective in protecting patients with large-vessel ischemic~     stroke and undergoing endovascular treatment is still unknown.~   "
27274|NCT03209999|"~     Using cross-sectional samples from over 40 Demographic and Health Surveys, the investigators~     studied the association between maternal employment and 3 indicators of Infant and Young~     Child Feeding (IYCF): exclusive breastfeeding (EBF) among children less than 6 months old~     (N=39,791) and minimum diet diversity (MDD) and minimum meal frequency (MMF) (N=137,208)~     among children 6 to 23 months old. Mothers were categorized as formally employed, informally~     employed, or non-employed. The investigators first used adjusted logistic regression models~     to assess the associations within each country. The investigators then used meta-analysis to~     pool associations across all countries and by region.~   "
27275|NCT03209986|"~     There has been great interest in recent years to take advantage of stem cells to treat liver~     cirrhosis. Mesenchymal stem cells (MSC) has been shown to be safe and effective for liver~     diseases in some studies. Randomization controlled studies are needed to confirm the long~     term effect of MSC treatment for liver cirrhosis. This study aimed to investigate the safety~     and efficacy of mesenchymal stem cells in hepatitis B and C related liver cirrhosis patients.~      This study is an open-label multicenter randomized control study. Patients with with~     decompensated cirrhosis will be randomly assigned to receive MSC treatment plus standard~     medical care(treatment）or standard medical care (control). Three times of MSC infusion~     (1x10E6 cells/kg body weight) via peripheral vein will be given to the experimental group~     (once in 4 weeks). The primary outcome is absolute change in liver function indexes and and~     scores. Secondary outcomes are cirrhosis-related complications, symptoms, life quality, and~     survival.~   "
27276|NCT03209973|"~     The study is to evaluate the efficacy of BGB-A317 assessed by Independent Review Committee~     (IRC) in subjects with relapsed or refractory classical Hodgkin lymphoma (cHL), as measured~     by Overall Response Rate (ORR) per the Lugano Classification~   "
27277|NCT03209960|"~     The purpose of this study is to improve spasticity diagnosis through development of a simple~     physical examination guide for primary care providers to identify patients who would benefit~     from being referred to a movement disorders neurologist for a spasticity evaluation.~   "
27278|NCT03209947|"~     There is currently no consensus on the normal ultrasound surface of the ulnar nerve at the~     elbow. The goal of this study is to study the ulnar nerve surface at the elbow in a~     population of asymptomatic subjects~   "
27279|NCT03209934|"~     The choice of antimicrobial therapy to treat complex bone and joint infections (BJI) is~     challenging, requiring consideration of: (i) the problem of bone diffusion; (ii) the~     necessity of using antimicrobials active against bacterial biofilms; (iii) the growing~     incidence of antibiotic resistance; and (iv) the high risk of severe adverse events (SAE) in~     response to first-line antimicrobials in these patients.~      Consequently, off-label use of recently developed antimicrobials, such as daptomycin, is~     frequently required as salvage therapy in complex BJI. Even if daptomycin does not have~     approval for the treatment of BJI, the Infectious Diseases Society of America guidelines~     propose this antibiotic as alternative therapy for prosthetic joint infection. The~     recommended dose is 6 mg/kg/d, whereas recent data support the use of higher doses in these~     patients as bone penetration of daptomycin is limited.~      The present cohort study aimed to assess the safety and efficacy of prolonged high-dose (>6~     mg/kg/d) daptomycin salvage therapy in patients with complex BJI.~   "
27280|NCT03209921|"~     Daptomycin is a cyclic lipopeptide that has been proposed as an alternative therapeutic~     option in patients with prosthetic joint infection caused by Staphylococcus or Enterococcus~     species in the latest Infectious Diseases Society of America (IDSA) guidelines.~      The population pharmacokinetics (PK) of daptomycin have been described in various groups of~     patients in previous publications. However, little information exists on the PK of daptomycin~     in patients with bone and joint infections (BJI). Also, previous population studies did not~     investigate daptomycin PK over prolonged therapy, and, to our knowledge, no study has~     reported the intraindividual PK variability of this drug.~      The aim of this study is to describe the inter- and intraindividual PK variability of this~     drug.~   "
27281|NCT03209908|"~     Pregnant women carry high HBV DNA loads before delivery, which is the most important factor~     leading to mother-to-child transmission of HBV. Nucleoside analogue antiviral treatment~     during late pregnancy can significantly reduce the incidence of HBV MTCT, but security~     problems of using NA treatment during pregnancy has not been eliminated, Therefore, the aim~     of our study is to explore the effect of starting to use Tenofovir Disoproxil Fumarate(TDF)~     antiviral treatment from the 32 weeks of gestation to block mother-to-child transmission of~     hepatitis B virus(HBV MTCT).~   "
27282|NCT03209895|"~     This study is designed to evaluate the effectiveness of a proprietary nutritional supplement~     that contains Krill Oil (KO), astaxanthin (AX) and hyaluronic acid (HA) to reduce pain and~     discomfort in participants, compared to an inert placebo (palm oil) control and to a positive~     control (glucosamine-chondroitin). The purpose of the study is to determine if the~     combination of KO, AX, and HA will benefit participants with joint pain.~   "
27283|NCT03209882|"~     This study evaluates the effects of transcranial infrared laser stimulation (TILS) on~     prefrontal metabolism and hemodynamics in veterans with post-traumatic stress disorder~     (PTSD). The subjects will receive six TILS interventions and one sham intervention in a~     course of seven weeks.~   "
27284|NCT03209869|"~     Subjects with relapsed or refractory neuroblastoma will receive ex-vivo expanded and~     activated natural killer (NK) cells from a haploidentical donor in conjunction with the~     immunocytokine, hu14.18-IL2.~   "
27285|NCT03209856|"~     The aim of this study is to evaluate the effect of treatment of vitamin D deficiency (through~     vitamin D supplementation for 8 weeks before the start of In-vitro fertilization (IVF) on the~     success of IVF cycles.~   "
27286|NCT03209843|"~     The objective of PERFECTO is to assess the reendothelialization at 3 months after~     successfully CTO percutaneous intervention (PCI) with new generation drug eluting stent (DES)~     by OFDI analysis. Designed as a multicentric, observational and prospective study which will~     be conducted at University Hospital of Poitiers (France), a systematic OFDI analysis will be~     realized immediately after CTO-PCI and at 3 months. Known as major predictive factors of~     stent thrombosis, percentages of malapposition, uncovered struts and neointimal hyperplasia~     proliferation will be measured over the entire length of each stent implanted combining in a~     composite primary endpoint.~   "
47551|NCT02944500|"~     The purpose of this protocol is to investigate the effect of treatment with the study drug~     Liraglutide, a GLP-1 receptor agonist, on centers of the brain that control appetite and food~     intake.~   "
27287|NCT03209830|"~     Many people who have undergone subarachnoid hemorrhage from an aneurysm (an artery of a vein~     in the brain) struggle with a pronounced fatigue as well as a number of other sequelae such~     as impaired concentration, memory deficits and emotional problems. Exhaustion is often~     permanent and can lead to a significant worsening of quality of life and be the cause of~     disability. This condition does not only have major consequences for the individual who is~     affected, but also for their families and for society. So far no effective treatment for~     fatigue has been found. The drug OSU6162 has shown a beneficial effect on fatigue and other~     impairments after stroke and after traumatic brain injury. There is good reason to believe~     that OSU6162 can also improve fatigue and other impairments after aneurysm bleeding and thus~     increase the chance of returning to the level of daily function they had before the bleeding.~     The study is double blinded and measures the effect of OSU6162 and placebo on fatigue and~     neuropsychological function.~   "
27288|NCT03209817|"~     This clinical trial aims to test the effects of consuming two types of tomato (one ordinary~     cherry red tomato containing lycopene, and the other a yellow cherry tomato low in lycopene),~     on cardiovascular risk factors including endothelial function as the primary outcome, and~     blood lipids, inflammatory factors and blood pressure.~      In a crossover design, participants of this study will randomly consume 300g of raw cherry~     (red and yellow) tomatoes per day for four weeks, with a control period consuming no tomato~     products. Before and after each intervention, the cardiovascular outcomes mentioned above~     will be measured in the clinic.~   "
27289|NCT03209804|"~     To evaluate the clinical benefits and risks of hybrid operating techniques in management of~     cerebral arteriovenous malformations.~   "
27290|NCT03209791|"~     In this study we plan to demonstrate that ethanol induces skeletal muscle autophagy to~     degrade MAA adducts.~   "
27291|NCT03209778|"~     Patients with schizophrenia suffer from autobiographical memory disorders. Patients have~     difficulty to remember vividly personal past events when they are specifically asked for.~     Indeed, this task requires a good executive functioning to retrieve precise information~     stored in long term memory. Interestingly, executive functioning has been showed impaired in~     schizophrenia and studies showed that their autobiographical memory impairments were directed~     related to their executive dysfunction.~      Yet, in daily life people remember more often autobiographical memories spontaneously,~     without trying voluntarily to recall them.~      In that case, the involuntary recall of personal past events is much less sustained by~     executive functioning.~      In this protocol the investigators would like to investigate and compare subjective~     characteristics of involuntary and voluntary autobiographical memories in order to highlight~     the role of executive dysfunction in patients' autobiographical memory impairments.~   "
27292|NCT03209765|"~     It is estimated that there are about 1.4 million patients with colorectal cancer (CRC)~     worldwide, with a rising trend in CRC incidence in many Asian Pacific countries. In Hong~     Kong, colorectal cancer ranks first in cancer incidence and second in cancer mortality based~     on data from 2014.~      Recent guidelines from USA, Europe and Asia Pacific region recommend CRC screening for~     average-risk asymptomatic individuals starting at age 50. Fecal immunochemical tests (FIT),~     is one of the recommendation as first-line modality for CRC screening. Since yearly testing~     is recommended to maintain programmatic effectiveness longitudinal adherence is a critical~     component of FOBT-based screening programs. Our previous study conducted in Hong Kong showed~     that the rate of compliance with CRC screening was declining since the first year of~     enrolment8.~      In recent years, social media (SM) has become an increasingly popular source of health~     information. By providing an easily accessible and interactive channel of communication~     between reviewers and information providers, it has potential values for affecting public~     health. However, the effects of SM on the compliance of CRC screening by FIT has not yet been~     studied.~      WhatsApp Messenger, is the most popular social media messaging app worldwide. This randomized~     controlled study will investigate the effect of WhatsApp vs no reminder on the compliance of~     CRC screening by FIT.~   "
27293|NCT03209752|"~     In this study, the accuracy of a new numerical method is evaluated for predicting the 3D~     effect of brace on idiopathic scoliosis. This method results from the combination of several~     innovative technologies: the EOS imaging system and the anatomical transfer developed by~     Anatoscope. This is an essential step in validating a digital tool that can be used in~     routine clinical practice.~   "
27294|NCT03209739|"~     It is estimated that there are about 1.4 million patients with colorectal cancer (CRC)~     worldwide, with a rising trend in CRC incidence in many Asian Pacific countries. In Hong~     Kong, colorectal cancer ranks first in cancer incidence and second in cancer mortality based~     on data from 2014.~      CRC is one of the most preventable cancers because its development in general follows an~     adenoma-carcinoma sequence. Adenomas are considered precursor lesions for CRC. Recent~     guidelines from USA, Europe and Asia Pacific region recommend CRC screening for average-risk~     asymptomatic individuals starting at age 50. Modalities such as guaiac-based fecal occult~     blood tests (gFOBT), fecal immunochemical tests (FIT), flexible sigmoidoscopy (FS), and~     colonoscopy are among the acceptable options for CRC screening.~      While early detection and removal of colorectal adenoma by screening colonoscopy with~     polypectomy reduce CRC incidence and mortality, interval cancers (cancers that develop after~     a colonoscopy and before the next scheduled colonoscopy) may still occur and were reported to~     account for up to 10.5% of CRC. a CRC has been associated with proximal colon location, small~     lesion, flat lesion, missed lesion, inadequate examination, incomplete resection of lesion,~     tumor biology, and low adenoma detection rate (ADR). High ADR (eg, ≥ 20%) has been associated~     with a reduced risk of interval CRC.~      Bowel preparation includes diet restriction and proper use of laxative before the~     colonoscopy, and this is one of the important factors to ensure a high quality colonoscopy.~     Suboptimal bowel preparation may lead to decreased ADR, cecal intubation rate, and~     surveillance interval and increased procedural time. Efforts to improve bowel cleansing~     quality through traditional communication routines, including face-to-face verbal education,~     written booklet or visual aids or telephone-based re-instruction have proven to be useful. A~     recent study using WeChat, a widely used social media mobile app in China, has also shown to~     be effectively improving bowel preparation level of a mixed population who received~     diagnostic (77%), screening (15.8%) and surveillance (7.2%) colonoscopy. However, the impact~     of social media mobile app on the bowel preparation level of screening colonoscopy is not yet~     known. Hence, this study will investigate the effectiveness of the most popular social media~     app worldwide, WhatsApp in bowel preparation level of screening colonoscopy.~   "
27295|NCT03209726|"~     The primary objective of this study is to develop an approach to determine eligibility for~     subcutaneous ICD by analyzing routine clinical 12-lead electrocardiogram.~   "
27296|NCT03209713|"~     This study is a two-arm randomized controlled trial, implemented to assess the effectiveness~     of a community-based educational program with and without a text messaging reminder system,~     in increasing the rate of HPV vaccination completion among children of Mexican Americans.~   "
27297|NCT03209700|"~     This study is an extension to re-treat partial and non-responders from the previously~     approved Phase 1 MCS-AFP protocols IRB #12-009716 (Crohn's Disease perianal fistulas) and~     15-003200 (cryptoglandular perianal fistulas).~   "
27303|NCT03209622|"~     A randomized controlled trial was conducted in cardiology department and smoking cessation~     center of University Hospital of Monastir (Tunisia). All smokers Hospitalized for ACS were~     included. Participants were randomly assigned to either group A, initiating Nicotine~     replacement therapy (NRT) in intra-hospitalization or a control group B that received NRT~     after hospital discharge. The end point assessment was smoking abstinence at 24 weeks~     following randomization, defined as self-reported abstinence in the past week before the 24~     week clinic visit confirmed by a measured exhaled carbon monoxide ≤8 ppm. Data were analyzed~     by intention to treat.~   "
27304|NCT03209609|"~     Prospective, multi-center, randomized, within-subject-controlled , trial, enrolling patients~     with multi vessel atherosclerotic coronary artery disease, scheduled to undergo SVG CABG with~     arterial grafting of IMA to LAD and two or more saphenous vein grafts. In each patient, one~     SVG bypass will be randomized to be supported by the VEST, while another will not be~     supported and serve as control. Thus, the full cohort will provide a basis for comparison~     between two sets of SVGs: A VEST supported set; and an unsupported set.~   "
27305|NCT03209596|"~     This study aimed to verify if orange juice supplementation can be a nutritional strategy to~     ensure an adequate energy and micronutrients ingestion, influencing metabolic responses of~     soccer players.~   "
27306|NCT03209583|"~     Congenital heart disease (CHD) affects approximately 1% of newborns in the US, with 25% of~     those affected having critical conditions requiring open heart surgery within one year of~     birth. Surgical and medical advances have allowed many patients to live beyond their fourth~     and fifth decades of life. Unfortunately, cardiac arrhythmias are a relatively common sequela~     due to cardiac anomalies and surgical scars in addition to residual volume and pressure load~     on the heart. Atrial arrhythmias, including sinus node dysfunction and intra-atrial~     re-entrant tachycardia (IART) are among the more common abnormalities found in adults with~     repaired CHD. The presence of IART significantly increases morbidity and mortality, and~     anti-arrhythmic medications have been shown to be a sub-optimal treatment strategy with the~     majority of patients requiring multi-drug therapy. Catheter ablation procedures remain a~     treatment option, but are less successful for some patient demographics. In the mid-1990's,~     pacemakers with atrial anti-tachycardia pacing (ATP) capabilities were developed, primarily~     for the management of atrial flutter and fibrillation in adults with structurally normal~     hearts. Given the need for pacemakers in the CHD population to manage sinus node dysfunction~     and atrioventricular node conduction block, the adoption of atrial anti-tachycardia~     pacemakers began to gain favor. However, there is limited data available comparing the safety~     and effectiveness of ATP therapy between various demographics of CHD patients. In the current~     study, the investigators aim to determine if ATP is an effective treatment strategy for IART,~     specifically within particular sub-populations of CHD patients. Additionally, investigators~     hope to delineate any significant differences in efficacy of ATP treatment between adult and~     pediatric congenital heart patients. The research team will accomplish our goals with a~     retrospective, multi-center study in which data is collected from existing electronic medical~     records and pacemaker interrogations. Following data collection, the investigators will~     employ statistical analyses to determine if certain CHD demographics are statistically~     significant predictors of ATP therapy outcomes.~      The purpose of this prospective/retrospective study is to determine how effective atrial~     anti-tachycardia therapies are with the congenital heart patients who are known to have~     atrial arrhythmias. As this population ages, we know that arrhythmic burden increases and~     medications are increased or changed for symptomatic improvement.~      Patients will be enrolled at the time of anti tachycardia device ATD placement or when device~     therapies are turned on. Patients will need a minimum of 5 years of clinical history prior to~     implantation and after implantation (unless patient is very young). Data will be collected~     both retrospectively and prospectively. The research team will consent patients at the time~     of clinical evaluations and scheduled follow-ups (usually 3 - 6 months). If therapy is~     effective, investigators will determine the specific programming which was successful. If~     therapy was ineffective, investigators will also determine if a change in programing was made~     and if this improved ATP efficacy. Investigators will also determine the arrhythmia burden.~     Cardioversion and medications before and after ATD implantation will be the key determinants~     of arrhythmia burden in this study.~   "
27307|NCT03209570|"~     The purpose of this study is to prospectively compare a standard of care manual toileting~     protocol (e.g., check and change strategy) to toileting patterns recorded by the TENA~     Identifi system in identifying incontinence patterns and events, and, whether such data~     differentially improve a care planning strategy, nursing effort, product use, and wet-time~     for urinary incontinence.~   "
27308|NCT03209557|"~     Investigators will assess the feasibility of implementing a randomized control trial of a~     behavioral intervention that uses smartwatch technology to monitor smoking behavior with~     texts aimed at reducing smoking in pregnant women who smoke. Investigators will compare the~     cessation rate of pregnant women who receive usual care through programs aimed at reducing~     smoking with pregnant women who receive usual care and are using the SmokeBeat app with a~     smartwatch.~   "
27309|NCT03209544|"~     The objective of the Think Life study is to test the effect of an online, unguided self-help~     intervention, i.e. Think Life. The primary hypothesis is that Think Life will reduce suicidal~     ideation. The secondary hypothesis is that Think Life will lead to improvements in depressive~     symptoms, hopelessness, rumination, and anxiety. Positive changes are expected after~     completing Think Life and at follow-up, twelve weeks after baseline.~   "
27310|NCT03209531|"~     The purpose of this study is to examine if thigh muscle weakness and the lack of muscle~     activation that accompanies ACL injury can be improved through a form of mental coaching and~     encouragement, known as operant conditioning.~   "
27311|NCT03209518|"~     The purpose of this study is to evaluate the safety in patients with premenopausal breast~     cancer receiving the drug in the routine clinical setting.~   "
27312|NCT03209505|"~     This study examines the development of Lid Wiper Epitheliopathy (LWE) in individuals fit with~     contact lenses having difference coefficients of friction (CoF)~   "
27313|NCT03209492|"~     The purpose of this study is to evaluate the safety in patients with prostate cancer~     receiving the drug in the routine clinical setting.~   "
27314|NCT03209479|"~     The purpose of this study is to evaluate the safety and efficacy of Copaxone subcutaneous~     injection syringe (hereinafter referred to as Copaxone) in patients with multiple sclerosis~     in the routine clinical setting.~   "
27315|NCT03209466|"~     There is controversy regarding the utility of antiseptics in wound management for diabetic~     foot ulcer syndrome. The aim of this study is to assess chlorhexidine gluconate at 0.125% vs.~     saline solution to reduce the ulcerated area in patients with diabetic ulcer syndrome. A~     clinical trial model to evaluate modifications in size and area is proposed. Patients to be~     included will be those with diabetic foot ulcers Graded II accordingly to the University of~     Texas wound classification system.~   "
27316|NCT03209453|"~     To identify the therapeutic effects of short-term family-centered work shop for children with~     developmental delays~   "
27317|NCT03209440|"~     Our long-term goal is to improve spiritual care outcomes for elderly patients with cancer.~     The study team will use a spiritual intervention, Dignity Therapy (DT), to help these~     patients maintain pride, find spiritual comfort, enhance continuity of self, and ultimately~     make meaning of their life threatening illness.~   "
27318|NCT03209427|"~     Pruritus is the commonest side effect of intrathecal morphine especially in parturient, but~     the exact mechanism of pruritus is not clear. Many mechanisms have been suggested. Among~     these mechanisms is the activation of the 5-HT3 receptors by the intrathecally injected~     morphine.~   "
27319|NCT03209414|"~     The impact of frailty on immediate and long term outcomes of invasive treatment of coronary~     artery disease is not fully characterized. The assessment of frailty may help physicians in~     the selection of best treatment option and in the timing and modality of the follow-up. The~     FRAilty syndrome in daily Practice of Interventional CArdiology ward (FRAPICA) study is~     designed with the aim to validate the use of the Fried frailty scale and instrumental~     activities of daily living scale (IADL) as prognostic tools in patients admitted to hospital~     for symptomatic coronary artery disease, either stable, unstable, or acute coronary syndrome~     (ACS).~      The FRAPICA study is a single center prospective study enrolling patients aged ≥65 years. The~     aims are (1) to describe Fried frailty scale and IADL scale distribution before hospital~     discharge and (2) to investigate the prognostic role of Fried frailty and IADL scores. The~     outcomes are: (1) results of invasive treatment, (2) its complications (periinterventional~     MI, contrast-induced nephropathy, blood loss), (3) three-year all-cause mortality,~     cardiovascular mortality, stroke, myocardial infarction, reintervention, heart failure,~     hospital readmission for any cause, and a composite of the above mentioned. Ancillary~     analyses will be focused on different clinical presentations, different tools to assess~     frailty and risk stratification.~      The FRAPICA program will fill critical gaps in the understanding of the relation between~     frailty, cardiovascular disease, interventional procedures and outcome. It will enable more~     personalized risk assessment and identification of new targets for interventions.~   "
47552|NCT02944487|"~     The objectives of this study were to evaluate the safety and tolerability of lucerastat, and~     to determine its pharmacokinetic profile as single oral doses at different strengths.~   "
27320|NCT03209401|"~     This is a multi-institutional Phase I dose-escalation and dose-expansion trial for patients~     with advanced, solid tumor malignancies who have pre-identified deleterious germline or~     somatic mutations in the homologous recombination deoxyribonucleic acid (DNA) repair pathway~     (HR deficient). The trial is designed to assess the efficacy and safety of niraparib plus~     carboplatin in patients with evidence of HRD. The primary endpoint will be identifying the~     recommended phase 2 dose (RP2D) and schedule of niraparib plus carboplatin, as well as~     establishing the anti-tumor efficacy of niraparib plus carboplatin as determined by Response~     Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.~   "
27321|NCT03209375|"~     This non-interventional study will test scoring systems used to identify high risk patients~     when they are triaged upon presentation in the Emergency Department (ED) in a single hospital~     in the Northwest of England between May and July 2017.E The study will involve collecting~     data only from a cohort of 500 consecutive patients who arrive at the ED. Patients who have a~     traumatic, purely obstetric or purely psychiatric condition will be excluded.~      Patients will be triaged as is routine by nursing and medical staff using various scoring~     methods determine whether they are high risk and need urgent, life-saving treatment. In~     addition the impression (yes/no) of the triaging nurse and the treating clinician as to~     whether the patient will need a life-saving intervention will be collected. Patients will be~     followed up for 48 hours to see whether they needed any life-saving treatment, such as~     admission to ICU, life-saving surgery, cardiopulmonary resuscitation (CPR), or death.~      Each patient's Manchester Triage category, NEWS at presentation, nurse and treating clinician~     impressions and a novel score calculated from NEWS data will be collected together with the~     outcome data in order to compare the predictive power of the five scoring systems. In this~     way the study will test which is the best scoring system for identifying high risk patients~     in a timely manner. This is important as it can allow life saving treatment to be delivered~     quickly to those patients who need it most and can prevent inappropriate interventions on~     patients who do not immediately need them. The study will collect minimal patient information~     and will not interfere with or alter their treatment in any way. Only patient data recorded~     as part of routine practice is required, which will be collected by members of the direct~     care team and will be anonymised prior to analysis.~   "
27322|NCT03209362|"~     The objective of the study is to evaluate the efficacy and safety of intra-articular~     injections of SI-613 compared with placebo for knee OA.~   "
27323|NCT03209349|"~     This study evaluates how often patients without sedation that receive screening sigmoidoscopy~     are able to have their full colon examined without significant discomfort by comparing a new~     colonoscopy technique known as the water exchange technique to the traditional air~     insufflation technique. It compares the differences between complete colon exam rates for~     water exchange when compared to the traditional air technique. Patients will be randomised~     and blinded to the procedure type.~      Previous studies have shown that the water exchange method is associated with a significant~     reduction in discomfort and often allows patients to receive colonoscopy without sedation or~     with only minimal sedation. However, the potential for water exchange to be used in the~     screening setting has yet to be evaluated. As per standard practices in sigmoidoscopy~     screening, patients will not be sedated. However, unlike standard practices in sigmoidoscopy~     screening, while maintaining minimal levels of discomfort, the investigators will attempt to~     scope beyond the distal colon.~   "
27324|NCT03209336|"~     To study the application of Intersphincteric Resection（ISR）combined with intraoperative~     radiation therapy(IORT) for ultra-low rectal cancer,and to broaden the surgical indications~     of Intersphincteric Resection（ISR.~      The study is aimed to assess the postoperative acute complication and the short-term acute~     efficacy on the patients with middle and low rectal cancer by treated with intraoperative~     radiotherapy,especially those with peritoneal inversion rectal cancer.~   "
27325|NCT03209323|"~     The aim of the study was to assess the influence of volatile induction of general anaesthesia~     with sevoflurane using two different techniques and intravenous anaesthesia with propofol on~     the possible presence of epileptiform electroencephalograph patterns during the induction of~     general anaesthesia. We aimed to verify whether presence of epileptiform patterns (EPs)~     defined as polispikes (PS), rhytmic polispikes (RPS), periodic epileptiform discharges (PED)~     on Electroencephalographs (EEGs) influence the behaviour of values of the Bispectral Index~     (BIS), State (SE) and Response (RE), A-line Auto Regressive Index (AAI) derived from middle~     latency auditory evoked potentials (MLAEP) during the induction of general anaesthesia using~     abovementioned techniques and such variations may be useful in detection of presence of EPs.~   "
27326|NCT03209310|"~     Cerebral palsy (CP) can be defined as a group of disorders of movement and posture, causing~     activity limitation that are attributed to nonprogressive deficits that take place in the~     immature brain. The motor disorders of CP are often accompanied by deficits in sensation,~     cognition, communication, perception, behavioral and respiratory system .~      Children with CP have many primary motor impairments such as selective mobility, muscle~     weakness, abnormal muscle tone, impaired coordination between agonist-antagonist muscles and~     insufficient postural control. These motor impairments also lead to secondary problems such~     as contractures and bone deformities. Whether primer or secondary, all these problems can~     reduce independence in activities of daily living (ADL) by affecting CP children at different~     levels.~      There are several studies in children with CP that investigate the effects of trunk control~     and/or respiratory functions. However, there are very few studies examining the relationship~     of these functions which have direct effects on ADL. In these studies, the functions of~     children who are more heavily affected and unable to move have been examined. However, there~     are no studies examining the effect of trunk control on respiratory muscle strength in~     children with CP with a better mobility level. There are many factors affecting both trunk~     control and respiratory functions in these children. Therefore, in children with CP, who have~     better functional level and can move on their own, revealing the interaction between trunk~     control and respiratory functions may contribute significantly to the treatment process. For~     this reason, this study was planned to investigate the effect of trunk control on ADL and~     respiratory muscle strength in children with CP having a Gross Motor Functional~     Classification System (GMFCS) levels of 1 and 2 and to compare them with healthy children.~   "
27327|NCT03209297|"~     TMD treatment, based on state of the art knowledge derived from clinical studies will be~     applied in patients with tinnitus and TMD. When this approach proves to be useful for the~     treatment of tinnitus, it offers a new therapeutic option for patients with tinnitus. To~     understand how TMD treatment works for patients with tinnitus, we will analyse mediating~     factors, i.e. factors that contribute to the therapeutic effect. To help clinicians in their~     clinical process we will identify prognostic indicators, i.e. factors that predict a positive~     or negative outcome of TMD treatment. This can provide a helpful tool in clinical practice.~   "
27328|NCT03209284|"~     The aim of this study is to analyze neoformed bone after maxillary sinus lifting with~     transcrestal approach, in atrophic crests (≤5 mm residual bone height). Clinical and~     laboratory data will be related to maxillo breast anatomy.~   "
27329|NCT03209271|"~     Fluid boluses are often administered with the aim of improving tissue perfusion in critically~     ill patients. It is unclear whether the temperature of the fluid has an impact on the~     hemodynamic response. The aim of this study is to describe the hemodynamic effects of a fluid~     bolus with two different temperatures.~   "
28279|NCT03196830|"~     This study is a single arm study to investigate the efficacy and safety of CAR-T targeted~     CD19/CD20/CD22/CD30 in relapse and refractory non-Hodgkin lymphoma patients. Ten patients~     will recruieted, admitted in hospital for 1 month for the CAR-T treatment and follow-up for~     at least 2 years.~   "
27330|NCT03209258|"~     Continued uncertainty exists over benefits of early intensive blood pressure (BP) lowering in~     acute intracerebral hemorrhage (ICH), related to the non-significant primary outcomes,~     patient selection, and discordant results of INTERACT2 and ATACH-II. We designed INTERACT3 to~     determine the effectiveness of a goal-directed care bundle of active management (intensive BP~     lowering, glycemic control, treatment of pyrexia and reversal of anticoagulation) vs. usual~     care in ICH.~      INTERACT3 is a large-scale pragmatic clinical trial to provide reliable evidence over the~     effectiveness of a widely applicable goal-directed care bundle in acute ICH.~   "
27331|NCT03209245|"~     Background. Immunotherapy in elderly patients is controversial, and there is still not much~     evidences supporting this treatment's safety and efficacy in this population. This study was~     performed to evaluate the safety and efficacy of specific injection immunotherapy for house~     dust mite allergens in patients over 65 years of age with allergic rhinitis and a confirmed~     allergy to house dust mites. The primary endpoint was the change from baseline in the mean~     average adjusted symptom score (AAdSS) and the total combined rhinitis score (TCRS)~     difference in the least square means in the label in comparison to placebo.~      Materials and methods. The study with double blind, placebo controlled trial was conducted in~     one centre. Fifty eight elderly patients with house dust mites allergy and AR were~     individually randomized in comparable numbers to one of two parallel groups: two years~     perennial AIT with the use Purethal Mites or placebo. Symptoms and medication score were~     presented as AAdSS and TCRS. Quality of life based on Rhinoconjunctivitis Quality of Life~     Questionnaire (RQLQ), serum allergen specific IgG4 to D.pteronyssinus and D. farinae and Der~     p1 and Der p2 were monitoring.~   "
27332|NCT03209232|"~     Objectives: To examine the effect of accelerated infliximab induction in children with~     moderate to severe UC. Design: A multi-center, prospective, randomized, open label study.~     Setting: Pediatric gastroenterology centers. Participants: Children 6 year to 17 years~     (Overall, 84 patients) with moderate to severe UC who are corticosteroid dependent/resistant~     thus planned to receive infliximab induction. Intervention: Group 1 (intervention) will~     receive an accelerated induction at 0,1,3 weeks (5 mg/kg) and then at week 7,11,15. Group 2~     (standard) will receive a per protocol induction at 0,2,6 weeks (5 mg/kg) and then at week~     14. Drug levels will be obtained prior to each infusion in each group (up to week 20).~     Further maintenance will be planned according to drug levels at weeks 15 and 14,~     respectively. Follow-up will continue without further interventions till 52 weeks following~     induction. Main outcome measure: Clinical remission, on infliximab at week 20. Secondary~     outcome measures: 1. Colectomy free rates at week 20 and 52. 2. Clinical remission on~     infliximab at week 52. 3. Drug levels and anti-drug antibodies prior to last study infusion.~     4. Anthropometric and laboratory measures including calprotectin at the end of induction,~     week 20 and week 52 5. Changes in fecal microbiome, virome and bile acids content. Sample~     size: In order to demonstrate 30% difference in clinical remission rate between groups is~     significant, we will need to study 36 children in each group to be able to reject the null~     hypothesis that the failure rates between the groups are equal with probability (power) of~     80% and a type I error probability of 0.05.~   "
27333|NCT03209219|"~     Brief summary: This study compares the long-term efficacy and safety of interferon (IFN) α2a~     and cyclosporine (cyclosporin A, CsA) following suppression of acute attack by high-dose oral~     glucocorticosteroid in patients with refractory Behçet`s uveitis (BDU). Half of the~     participants will receive IFNα2a while the other half will receive CsA.~   "
27334|NCT03209206|"~     The investigators evaluated the efficacy of a single early intravesical instillation of~     doxetaxel in the prevention of bladder recurrence after nephroureterectomy or distal~     ureterectomy for upper urinary tract urothelial carcinoma (UUT-UC).~   "
27335|NCT03209193|"~     Volatile anesthetics, such as sevoflurane and desflurane, are commonly used in patients~     undergoing cardiac surgeries including off-pump coronary artery bypass. However, the effect~     of volatile anesthetics on microcirculation in patients undergoing off-pump coronary artery~     bypass has not been well conducted.~   "
27336|NCT03209180|"~     Assessment of clinical effect and treatment quality of immediate release carvedilol (IR)~     versus slow release carvedilol (SR) in patients with HFrEF~   "
27337|NCT03209167|"~     The purpose of this study was to specifically compare the long term patient satisfaction of~     the abdomen after DIEAP flap procedure with conventional abdominoplasty.~   "
27338|NCT03209154|"~     The aim of the study is to investigate and explore the most important aspects of~     drug-adherence in the treatment of hypertension in order to improve treatment and blood~     pressure control, implying that new knowledge will reduce morbidity and mortality.~   "
27339|NCT03209141|"~     Arterial hypertension (AHT) is responsible for important morbidity and mortality. The cardiac~     repercussion of AHT is usually assessed by electrocardiography and echocardiography,~     time-consuming, technically demanding examinations that require experienced operators, which~     limits their use for screening diastolic dysfunction. Alternative tools for the screening of~     diastolic function in hypertensive patients are needed. Impedance cardiography (IC) is~     presently used in the study of AHT and in the optimization of antihypertensive therapy. It~     seems an attractive and economical option to change the clinical approach for screening;~     however, its validation in well-defined populations is required to sustain its use in~     clinical practice. The IMPEDDANS study aims to validate IC for screening left ventricular~     diastolic dysfunction in outclinic patients with AHT, using functional echocardiography as~     the clinical standard. Descriptive and analytical study with analysis of the agreement~     between the diagnosis of diastolic dysfunction and its degree, as well as the parameters~     obtained by impedance cardiography and echocardiography in patients with AHT.~   "
27340|NCT03209128|"~     Hippocampus and amygdala are parts of the brain involved in the recognition of emotions,~     memories, memory, language ... It is therefore very important to protect them during~     irradiation of the brain.~      The aim of this study is to evaluate cerebral irradiation with saving hippocampus and~     amygdala protects these brain functions in patients with small cell lung cancer (SCLC)~     Radiotherapy of the brain~   "
27341|NCT03209115|"~     Influence of Calcium hydroxide Chlorhexidine Combination vs. Calcium Hydroxide as an Intra~     canal Medicamentson Postoperative flare -up following two-Visit Endodontic Retreatment cases~   "
28351|NCT03195881|"~     This study investigates the relationship between optic nerve sheath diameter and increased~     intracranial pressure and its effect on neurologic outcome in post-cardiopulmonary arrest~     patients.~   "
27343|NCT03209089|"~     This is a multi-centre observational, ambispective study, which will retrospectively and~     prospectively collect clinical variables and socio-demographic data from medical records of~     patients with type 2 diabetes mellitus (T2DM) initiated with dapagliflozin by general~     practitioners (GPs) and endocrinologists in real-life setting. It is anticipated that patient~     recruitment will last 8 months (from Q3 2017 to Q1 2018) and each patient will be followed~     during the second visit 6±3 months later after the first visit. There are 2 time points:~        -  Baseline data: baseline data are defined as data available within 3 months prior to the~          first dose of dapagliflozin. In case of presence of multiple data values within baseline~          period the most recent pre-dose value will be selected~        -  Follow-up data: any post-baseline data will be considered as follow-up but the primary~          analysis will be focused on data available at 6±3 months after the first visit. In case~          of discontinuation dapagliflozin, data will be collected at routine visit within 3-month~          time frame after the last dose.~   "
27344|NCT03209076|"~     Prospective randomized trial comparing robotic versus laparoscopic Low anterior resection for~     rectal cancer.~      Primary endpoint: Compare urinary dysfunction between robotic and laparoscopic approach.~   "
27345|NCT03209063|"~     Recurrent miscarriage is a pregnancy loss before 20 weeks of gestation. The recurrent~     pregnancy loss usually occurring in the first trimester of gestation and its rate is quite~     high (15-20% even in full reproductive period) . In 2012, the American Society for~     Reproductive Medicine Practice Committee issued a statement that defined recurrent pregnancy~     loss as a disease distinct from infertility defined by two or more failed consecutive~     pregnancies.~   "
27346|NCT03209050|"~     Pre-market Investigational device exemption study evaluating the safety and efficacy of the~     Surfacer System to facilitate stable upper body central venous access suitable for any~     conventional catheter.~   "
27347|NCT03209037|"~     Pegylated interferon α-2a(Peg-IFN-α) not only inhibit viral replication, but also play an~     important role in immune regulation, while Nucleoside analog(ue) drugs only inhibit viral~     replication. In hepatitis B infection, CD8+T cells are the main effector cells in adaptive~     immune response. This study was aimed at investigating the changes of CD8+T cells frequency~     and function, and the expression of costimulatory molecules during Peg-IFN-αand nucleoside~     analog(ue) therapy.Meanwhile, the investigators want to verify whether Peg-IFN-α suppressed~     the virus and the reduction of virus led to the recovery of CD8+T cells function, or Peg IFN~     - alpha enhanced CD8+T cells function which gave rise to the decline of the virus.~   "
27348|NCT03209024|"~     Background: Hypertension is the leading attributable risk factor for cardiovascular disease~     and death globally. In diagnosing and monitoring hypertensive patient population, home blood~     pressure monitoring (HBPM) has been shown to be superior to the office-based blood pressure~     (BP) measurement as a predictor of cardiovascular disease and total mortality. However, the~     conventional method of HBPM utilizing handwritten BP logbooks has known shortcomings, mainly~     attributable to inaccuracy and underreporting of data, as well as the failure to bring the~     logbooks to the regular outpatient appointments. In recent years, the availability of home BP~     devices with Bluetooth® technology on the market, the increasingly widespread use of~     smartphones, and the development of mobile applications (apps) that complement Bluetooth®~     enabled BP monitors have expanded the potential for an accurate log of BP data to be~     accessible to clinicians. Our study's primary aim is to compare the level of HBPM recording~     fidelity using smartphone app versus using a handwritten logbook among the multi-ethnic~     hypertensive patient population seen in a district polyclinic located in Pasir Ris,~     Singapore. Patient acceptability of the two recording modalities and the association between~     the home blood pressure recording fidelity and the patients' socio-demographic background,~     self-care profile, clinical factors, and level of exposure to technology is also assessed as~     exploratory aims. Our main hypothesis is that the level of fidelity in HBPM recording,~     defined as the proportion of scheduled number of home blood pressure readings that is~     successfully recorded, regimen compliant, and made available at the final follow up visit,~     would be higher for patients who use a smartphone app versus those who maintain a handwritten~     logbook.~      Methods/design: Open, randomized controlled trial of 80 patients seen at Pasir Ris Polyclinic~     randomized to either intervention or control arm and assessed after a 3-week follow up period~      Intervention arm: Participants randomized to intervention arm follow a 3-week HBPM regimen~     and wirelessly record the BP readings onto a smartphone app using Bluetooth® technology.~      Control arm: Participants randomized to control arm follow a 3-week HBPM regimen (identical~     to intervention arm) and manually record the BP readings onto a handwritten logbook.~      Participants: A convenience sample of 80 patients visiting the study polyclinic was obtained~     during the recruitment period (15 Mar 2017 - 15 June 2017).~      Outcomes: A trained outcomes assessor will assess each participant's home BP record brought~     to the final follow up visit at 3 weeks post-randomization. The primary outcome will be HBPM~     recording fidelity, defined as the proportion of scheduled number of home blood pressure~     readings that is successfully recorded, regimen compliant, and made available at the final~     follow up visit. The participants' level of discomfort during the study, their willingness to~     incorporate into their healthcare management the modality of HBPM to which they were~     assigned, and their overall impression on their study participation will be assessed by a~     participant acceptability questionnaire.~   "
27349|NCT03209011|"~     Pegylated interferon α-2a(Peg-IFN-α) not only inhibit viral replication, but also play an~     important role in immune regulation, while Nucleoside analog(ue) drugs only inhibit viral~     replication. In hepatitis B infection, CD4+T Cells are the main effector cells in adaptive~     immune response. This study was aimed at investigating the changes of CD4+T Cells frequency~     and function, and the expression of costimulatory molecules during Peg-IFN-αand nucleoside~     analog(ue) therapy.Meanwhile, the investigators want to verify whether Peg IFN - alpha~     suppressed the virus and the reduction of virus led to the recovery of CD4+T Cells function,~     or Peg IFN - alpha enhanced CD4+T Cells function which gave rise to the decline of the virus.~   "
27350|NCT03208998|"~     Pegylated interferon α-2a(Peg-IFN-α) not only inhibit viral replication, but also play an~     important role in immune regulation, while Nucleoside analog(ue) drugs only inhibit viral~     replication. In hepatitis B infection, NKs are the main effector cells in early antiviral~     innate immune response. This study was aimed at investigating the changes of NKs frequency~     and function, and the expression of costimulatory molecules during Peg-IFN-αand nucleoside~     analog(ue) therapy.Meanwhile, investigators want to verify whether Peg IFN - alpha suppressed~     the virus and the reduction of virus led to the recovery of NKs function, or Peg IFN - alpha~     enhanced NKs function which gave rise to the decline of the virus.~   "
27351|NCT03208985|"~     This study is designed to assess whether consumers select and use ella® (ulipristal acetate~     30mg), an emergency contraceptive, in a manner consistent with the OTC package directions in~     an OTC-like setting.~   "
27352|NCT03208972|"~     The study compares in a randomized controlled way two stimulation methods. One of these~     stimulation methods implements a new insight in ovarian follicular growth. If this novel~     method of stimulation proves to be as efficient as the classical stimulation protocols, there~     might be a dramatic reduction of the costs of the medical therapy in IVF, thus reducing also~     the overall IVf costs significantly.~   "
27353|NCT03208959|"~     IDO1 is expressed in a wide variety of human tumors (eg. bladder, breast, colon, DLBCL,~     HNSCC, lung, ovarian, uterine, renal…), and contributes to tumoral resistance. HTI-1090 (also~     referred as SHR9146 in nonclinical study reports) is an orally bioavailable, highly potent,~     novel small-molecule IDO1/TDO dual inhibitor, with favorable preclinical oral bioavailability~     and safety profiles.~   "
27354|NCT03208946|"~     The aim of this study is to evaluate the effect of carboxymethyl-lysine (CML) on the levels~     of absorption and excretion of CML, and in the microbiota of healthy adults. To achieve the~     objective, a randomized clinical trial will be carried out. Before the intervention, subjects~     will have a washout period for seven days, then they will be randomly assigned to either a~     high-CML or to a low-CML diet for 5 days. Both groups will consume the foods provided by the~     researchers at the research center. Diets for this intervention will be based on an~     isocaloric diet that will include breakfast, lunch, snacks and dinner.~      Blood samples will be taken the first day, the second day of the intervention, and after the~     five days of the intervention. Urine and fecal samples will be taken the day before the~     intervention and after the intervention. CML levels will be measured by Liquid chromatography~     tandem-mass spectrometry in serum and urine samples to evaluate the levels of absorption and~     excretion. DNA extraction from the fecal sample will be carried out by a commercial kit.~     Bacterial log10 number of copies will be determined by using q-PCR.~   "
27355|NCT03208933|"~     This study is a national, multicenter, interventional, non-randomized, non-controlled,~     open-label study to assess the effectiveness of pirfenidone in participants with IPF in~     Russian clinical practice.~   "
27356|NCT03208920|"~     The purpose of this study is to determine if high-dose PUFA supplementation in patients~     undergoing EVAR for infra-renal AAA reduces the peri-operative inflammation.~   "
27357|NCT03208907|"~     Plasmodium vivax can be cause of severe malaria and mortality. There are serious public~     health implications associated with cases of P. vivax resistant to Chloroquine in the~     Americas as well there are efforts of many countries to eliminate this disease. In this way,~     it is critically important to evaluate an alternative radical cure treatment efficient to~     amazon scenario. The objectives of this trial are to demonstrate the superiority of adequate~     parasitological response at D42 of Dihydroartemisinin plus Piperaquine (DHA-PQP or~     Eurartesim®) versus Chloroquine and to evaluate the proportion of failure until D180~     considering different starting days of Primaquine (0.50 mg/kg/day) for 14 days. It is an~     open, 4 arms, randomised, comparative trial. Total of 460 patients must be included. To~     demonstrate the superiority of DHA-PQP compared to Chloroquine, the 95% confidence interval~     of the difference observed between both treatment success rates will be determined. Each~     recurrence will be passively and actively detected for 180 days.~   "
27358|NCT03208894|"~     to see the effects of slabutamol and IV furosemide in the treatment of transient tachypnea of~     newborn~   "
27359|NCT03208881|"~     This is a substudy to a randomised trial investigating the effect of liraglutide on body~     weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864). In~     the parent trial, patients will be subjected to an 8-week diet intervention phase including a~     low-calorie diet and dietetic counseling, after which patients will be randomised to receive~     either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on~     re-introducing regular foods and a focus on continued motivation to engage in a healthy~     lifestyle.~      This substudy aims to investigate any changes in the thickness of Adventitia, Extra-media~     (EMT) and veia jugularis assessed by ultrasound in relation to an initial 8-week weight loss~     intervention.~      Change will be assessed by grey-scale ultrasound, the area measured will be from the anterior~     wall of arteria carotis interna to the jugular vein including the wall of the vein,~     subsequent the thickness of the artery will be subtracted to measure the thickness of the of~     Adventitia, Extra-media (EMT) and veia jugularis interna compelx.~   "
27360|NCT03208868|"~     Loss of skeletal muscle mass or sarcopenia is the most common and potentially reversible~     complication in cirrhosis that increases morbidity and mortality before, during and after~     liver transplantation. No proven treatments exist for the prevention or reversal of~     sarcopenia in cirrhosis, primarily because the mechanisms responsible for this are unknown.~     Based on compelling preliminary studies and those of the co investigator, investigators~     hypothesize that the mechanism of reduced skeletal muscle mass in cirrhosis is due to a~     myostatin mediated impaired mTOR (mechanistic target of rapamycin) signaling resulting in~     reduced protein synthesis and increased autophagy. Investigators further postulate that~     leucine, a direct stimulant of mTOR, will reverse the impaired mTOR phosphorylation in the~     skeletal muscle of cirrhotics. The consequent increase in protein synthesis reduced autophagy~     will result in an increase in skeletal muscle mass. Investigators will test these hypotheses~     by quantifying the response to acute and long term (3 month) administration of leucine~     enriched essential amino acid (EAA/LEU) compared with an isonitrogenous isocaloric~     non-essential balanced amino acid mixture (does not stimulate protein synthesis) in cirrhotic~     patients. Fractional protein synthesis rate (FSR) in skeletal muscle, responses of the~     molecular regulatory pathways of skeletal muscle protein synthesis, and autophagy flux will~     be quantified in the acute and long term protocols. Tracer studies using L-[D5]-phenylalanine~     (Phe) as a primed constant infusion (prime 2µmol.kg-1.hr-1; constant 0.05 µmol.kg-1.hr-1)~     with and L [ring-D2] tyrosine, forearm plethysmography, and sequential skeletal muscle~     biopsies (total of 3 per study subject) will be used to quantify these outcomes.~     Anthropometric, clinical and body composition measures will be additional outcome measures~     for the long term intervention. Expression of regulatory signaling proteins, myostatin, IGF-1~     (insulin like growth factor) , phospho-Akt, phospho-AMPK (activated protein kinase),~     phospho-mTOR and phospho-p70s6k will be quantified by Western immunoblots. Autophagy flux~     will be measured by quantifying expression of the autophagosome proteins.~   "
27361|NCT03208855|"~     Substance Use Disorders (SUDs) and insomnia are major public health concerns, and each are~     independently linked to reduced quality of life, disability, and high healthcare costs.~     Insomnia, characterized by difficulty initiating or maintaining sleep, or nonrestorative~     sleep, is prevalent in 10% of the general population and is co-morbid in 70% of patients with~     SUDs. Primary insomnia and SUDs are chronic, unremitting diseases and have a complex~     bidirectional relationship. Insomnia symptoms may predate the onset of SUDs and may explain~     high prevalence of self-treatment. Insomnia may also be a direct effect of intoxication,~     withdrawal, or abstinence from the substance of abuse. Subjective and objective measures of~     sleep disruption have been shown in various stages of abuse and recovery. Insomnia is the~     most well documented predictor of substance use relapse. Treatment specifically targeting~     chronic insomnia is essential for improved clinical outcomes. Although, chronic insomnia is a~     well-established, modifiable risk factor, to our knowledge, there are no interdisciplinary~     residential treatment programs that specifically treat chronic insomnia during acute SUDs~     treatment. We propose that improved treatment of insomnia as part of a comprehensive~     reinforcement-based outpatient treatment program will provide an efficient and cost effective~     opportunity to improve standard outpatient SUD. Converging evidence suggests that~     prophylactic CBT-I during SUD treatment may have short and long-term efficacy for sleep, and~     improve attrition. In the proposed study, patients with co-morbid SUDs and insomnia will~     engage in an 8-week group CBT-I (gCBT-I) program in addition to receiving treatment as usual~     for SUDs. This study may provide new hope to effectively treat insomnia in SUD and lead to a~     new standardization of outpatient care. We hypothesize that a CBT-I intervention can be~     implemented as part of an evidence-based SUD treatment program within a residential facility.~   "
27400|NCT03208348|"~     Drs. from the Mayo Clinic Rochester will plan and execute a feasibility study of the phase I~     prototype version of the Virtual Reality exposure therapy system. Dr. X, who has significant~     experience in evaluating patient experiences and opinions of technologies intended to change~     behavior, will oversee a qualitative study to examine the prototype system. Twenty children~     with generalized anxiety disorder with perfectionism who have received less than 3 treatment~     sessions and a parent will be recruited to pilot the Virtual Reality system.~   "
27362|NCT03208842|"~     After gaining verbal consent , Patients included in this study will be subjected to:~        1. history taking :~             -  peronal history .~             -  obstetric history.~             -  past history~        2. general examination including vital signs~        3. abominal and pelvic examination~        4. the patient will be examined son graphically at 3 visits~             1. The first visit at less than 10 weeks gestation :trans vaginal ultrasound with~               partially filled bladder to nullify effect of anteversion of the uterus for~               assessment of---the site of the intrauterine gestational sac in relation to the~               endometrial cavity . For the purposes of this study and to obtain consistent~               findings, it was decided to have only five subgroups of gestational site~               implantation in relation to the endometrial cavity (Fig. 2):~                  1. anterior,~                  2. posterior,~                  3. Fundal,~                  4. low-lying anterior,\~                  5. low lying posterior We adopted the definition of implantation site from~                    previous publication (Abdallah et al., 2012). The implantation site is~                    visualized in the sagittal plane as a hyperechoic ring that occupies one side~                    of the implanted gestational sac and protrudes into the endometrial lumen It~                    represents the maternal decidual reaction and the beginning of maternal-fetal~                    circulation. This area is also believed to be responsible for future placental~                    formation and development (Brosens and Gellersen, 2010) Distance between the~                    implantation site and the internal cervical ostium (os). This was taken from~                    the lower end of the hyperechoic trophoblast ring of the gestational sac to~                    the internal cervical os in the sagittal plane.~                       -  doppler assessment of the retro chorionic blood flow in the area behind~                         the maximum chorionic tissue to detect sensitivity index (RI),in cases of~                         low gestational sac Doppler assessment of peri trophoplastic blood flow~                         will be assessed.~             2. then the patient will be enrolled during routine ANC till delivery and data~               collected at32-34 weeks gestation regarding placental site will be correlated with~               1st data and data at delivery~   "
27363|NCT03208829|"~     Subjects submitted to unilateral THA will be randomized into two rehabilitation groups. One~     group will receive a booklet with guidelines for postoperative care, while the other group~     will participate in face-to-face sessions with exercises with emphasis on muscle~     strengthening.~   "
27364|NCT03208816|"~     This study will be conducted at La Liga Contra el Cancer in San Pedro Sula, Honduras. The~     overall objective of this project is to improve symptom management for patients undergoing~     chemotherapy in Honduras. The first step in this line of research is a proof of concept~     feasibility study in which the investigators will demonstrate their ability to train nurses~     to administer a non-pharmacological, telephone-delivered, symptom management program for~     chemotherapy patients.~   "
27365|NCT03208803|"~     In patients with myelofibrosis, ruxolitinib is a current therapeutic option, which has~     demonstrated rapid and durable reduction in splenomegaly and improved disease-related~     symptoms. Anemia is another frequent issue in myelofibrosis. Consistent with its JAK2~     signalling inhibition, ruxolitinib therapy has been shown to be detrimental on the hemoglobin~     level, increasing the depth of anemia or transfusion need.~      Despite potential antagonistic mechanisms of action on Janus Kinase 2, some responses on~     anemia have been reported with the addition of Erythropoiesis-stimulating Agent to~     ruxolitinib in a small subset of patients in the COMFORT II study.~      Ruxo-EPO is an observational study aimed to better assess the combination of~     Erythropoiesis-stimulating Agent and a Janus Kinase 2 inhibitor for therapeutic efficacy on~     anemia, Myelofibrosis evolution and for tolerance, in a larger cohort of patients treated for~     myelofibrosis in general practice.~   "
27366|NCT03208790|"~     The present randomized, controlled, parallel-grouped trial includes 81 patients (aged 18 to~     75 years) suffering from oral potential premalignant lesions. Patients will be randomly~     assigned into 3 equal groups: Group A:Thymoquinone group 100mg Group B:Thymoquinone group~     200mg Group C:Control group (placebo)~   "
27367|NCT03208777|"~     Colorectal carcinoma is a heterogeneous disease that is caused by the interaction of genetic~     and environmental factors. colorectal carcinoma encompasses a complex disease with different~     molecular pathways and biological characteristics arising from a multi-step process that~     implicates several genetic and epigenetic events . The multi-step genetic model involves the~     loss of function of tumor suppressor genes, such as adenomatous polyposis coli (APC),~     Telomeres could be a promising marker due to the fact that their lengths change in the~     colorectal polyp-carcinoma sequence . Moreover, telomere length (TL) is altered in blood~     cells in patients with colorectal carcinoma~        -  These findings could suggest that changes in TL may take place before the development of~          the tumor .~      The two main forms of inflammatory bowel disease (IBD), ulcerative colitis (UC) and Crohn's~     disease (CD) are characterized by chronic intestinal inflammation and risk of progression to~     colon cancer. One proposed cause of the latter characteristic is chromosome instability,~     since the rearrangement of genetic material can lead to activation of oncogenes, loss of~     tumor suppressor genes and other changes that lead to uncontrolled cell growth. Chromosome~     instability is particularly associated with UC and has been observed in colon epithelial~     cells and peripheral blood mononuclear cell. Since genomic instability in peripheral blood~     mononuclear cells (PBMCs) has been used as a biomarker for global cancer risk in a number of~     diseases, the latter observation suggests the possibility of a chromosome instability~     syndrome in UC that could affect all tissues. One possible cause of chromosome instability is~     telomere dysfunction .~   "
27368|NCT03208764|"~     A Prospective, Open labeled, multi-Center, Evaluation of the Efficacy Safety and Tolerability~     of Nitric Oxide Given Intermittently via Inhalation to Subjects with NTM (specifically MABSC)~      Nitric Oxide (NO) has been shown to play a critical role in various biological functions. In~     the airways, NO is considered to play a key role in the innate immune system in which the~     first-line of host defense against microbes is built.~      In vitro studies suggested that NO, in part per million (ppm) concentrations, possesses~     anti-microbial activity against a wide variety of phyla including fungi, and~     antibiotic-resistance bacteria.~      In this study the investigators wish to evaluate the efficacy, safety and tolerability of 160~     ppm Nitric Oxide intermittently delivered via inhalation to subjects infected with~     Non-tuberculosis mycobacteria (NTM), specifically with MABSC.~   "
27369|NCT03208751|"~     Regular exercise training has shown to improve exercise capacity in patients with~     cardiovascular disease. The feasibility and transferability of exercise training in a~     community based cardiovascular rehabilitation setting is currently less well investigated.~     The objective of this study is to translate regular exercise training into a community based~     setting. A 6 months training intervention program with lifestyle counseling is performed,~     with both supervised training in rehabilitation centres as well as home based training. The~     aim of the project is to implement this program for a wider patient population and to improve~     exercise capacity, diastolic function as well as cardiometabolic parameters.~   "
27498|NCT03207061|"~     Aim: Assess the diagnostic accuracy of 3D Ultrasound, compared to MRI and final histology~     with respect to myometrial invasion of endometrial cancer.~      This study will assess whether 3D ultrasound is accurate at predicting myometrial invasion~     aqnd lymph node metastasis of endometrial cancer. All patients will receive routine standard~     of care (MRI). The results of the 3D ultrasound will be compared to the MRI report and final~     histology.~   "
27370|NCT03208738|"~     Concept: Alcohol misuse is common among Veterans with PTSD. It has been proposed that this~     high comorbidity is the result of self-medication, with alcohol being used to alleviate~     common PTSD symptoms (e.g., hyperarousal, sleep problems). Given this high prevalence and~     functional relationship, researchers at the BSD of the NCPTSD developed the VetChange~     self-management website to concurrently address these conditions. In a large scale RCT,~     VetChange has shown efficacy to reduce both alcohol misuse and PTSD symptoms. Unfortunately,~     the recently launched publicly available VetChange website (Vetchange.org) has been plagued~     by a high rate of visitors not completing the mandatory registration process, which is~     required for repeated use. Based on the promising findings of the VetChange research, the D&T~     Division partnered with the BSD Division to develop the VetChange mobile app, which is set to~     be released to the public very soon. However, unlike the VetChange website, the app has not~     yet been evaluated and has the advantage of allowing users to easily obtain it without having~     to register and repeatedly log on through an Internet connection.~      This research partnership between the D&T and BSD Divisions will extend and enhance an~     ongoing successful cross-center collaboration in a high priority topic for the larger Center.~     The purpose of this proposal is to conduct a pilot evaluation of the VetChange mobile app in~     order to test its feasibility, acceptability, and potential efficacy to reduce alcohol~     consumption, PTSD severity, and improve psychosocial functioning among Veterans with PTSD who~     exhibit signs of problem drinking. In this study, 280 Veterans with problem drinking and~     clinically significant PTSD symptoms will be recruited using social media and randomized in~     equal numbers to receive one of four conditions: 1) Assessment only, 2) VetChange mobile app~     only, 3) AFT plus the VetChange mobile app supplemented with a package of supportive~     accountability tools (VetChange+). In addition to receiving the mobile app, VetChange+~     participants will receive SMS reminders to log drinking behavior using the mobile app. The~     investigators will track objective use of the VetChange mobile app to assess feasibility, and~     this usage data will also be used in real-time to tailor the content of text messages~     provided to participants in the VetChange+ condition. Participants will complete measures of~     alcohol use, functional well-being, and PTSD symptoms at baseline and again after 8 weeks~     (posttreatment). At post-treatment, participants in the VetChange app arms of the study will~     also be asked to report their level of satisfaction with the app and to complete a brief~     qualitative evaluation of their experience using the VetChange mobile app.~      Results of this pilot study will be used to characterize the feasibility, acceptability, and~     potential efficacy of a mobile app-based self-management intervention to reduce problem~     drinking behavior in Veterans with PTSD, will inform optimization of the intervention, and~     will serve as the foundation for subsequent proposals for extramural funding.~   "
27371|NCT03208725|"~     The CHAIN Network aims to identify modifiable biomedical and social factors driving the~     greatly increased risk of mortality among young undernourished children admitted to hospital~     with acute illness, as inpatients and after discharge. The study will inform priorities,~     risks and targeting for multi-faceted interventional trials.~      CHAIN is a multi-centre cohort study with a nested case control analysis of stored biological~     samples. Study sites are located in Africa and South Asia. Children will be recruited at~     admission to hospital, stratified by nutritional status. Exposures will be assessed at~     admission, during hospitalisation, at discharge, and at two time points after discharge. The~     main outcomes of interest are mortality, re-admission to hospital and failure of nutritional~     recovery up to 180 days after discharge. To determine community health norms, an additional~     sample of children living in the same communities will be enrolled and assessed at one time~     point only.~   "
27372|NCT03208712|"~     This is a single-arm, single-site pilot of Radium-223 (55 kBq/kg) IV q3 weeks for up to 6~     doses in combination with Atezolizumab 1200mg IV once every 3 weeks until investigator~     determined lack of benefit, unacceptable toxicity, or 17 doses in patients with urothelial~     carcinoma with bone metastases who have disease progression after platinum-containing~     chemotherapy.~   "
27373|NCT03208699|"~     Eating disorders (ED) are often undetected in the general population resulting in delayed~     treatment. The SCOFF questionnaire has been validated for eating disorders screening in~     primary care, but does not identify the type of eating disorder.~      Objective: Investigators evaluated the performance of a clinical algorithm (ExpaliTM)~     combining answers to SCOFF questionnaire with Body Mass Index (BMI) to identify four Broad~     Categories of ED derived from DSM-5.~      Design: Clinical algorithm (ExpaliTM) was developped from 104 combinations of BMI levels and~     answers to five SCOFF questions. Two senior ED specialists allocated each combination to one~     of the four Broad Categories of ED (DSM-5 diagnostics): restrictive disorder (anorexia~     nervosa typical, atypical and restrictive food intake disorders), bulimic disorder (typical~     and with low frequency or duration), hyperphagic disorder (binge eating disorders typical and~     with low frequency or duration) and other specified ED. The performance of ExpaliTM was~     evaluated on data from patients referred to the Nutrition Department including a precise~     DSM-5 diagnosis of ED, a positive SCOFF test (at least 2 yes answers) and BMI. Sensitivity,~     specificity values with a 95% confidence interval (95% CI) and Youden index were calculated~     for each category.~   "
27374|NCT03208686|"~     The purpose of this application is to create and implement a targeted, culturally grounded,~     diabetes self-management intervention for Black men that uses social support, mobile health,~     and remote sensing technology to improve diabetes-related outcomes.~   "
27375|NCT03208673|"~     This is an open label study of Optive eyedrops and gel combination for day and night dry eye~     management~   "
27376|NCT03208660|"~     This study is conducted to assess the retention rate of Fycompa when given in routine~     clinical care.~   "
27377|NCT03208647|"~     To ascertain the risk factors of AA in ZheJiang Province of China at the moment, especially~     the comprehensive multiple factors risks. The author conducted a case-control research~     included 338 AA cases and 1464 controls. Subjects were surveyed using same standard~     questionnaire including personal data, past histories of diseases, family history and~     histories of occupational and daily exposure to harmful substances. Single and multiple~     Logistic regression analyses were made using SPSS17.0 on the dates to study potential factors~     in the development of AA.~   "
27378|NCT03208634|"~     Robotic rehabilitation is promising to promote function in stroke patients. The assist as~     needed training paradigm has shown to stimulate neuroplasticity but often cannot be used~     because stroke patients are too impaired to actively control the robot against gravity. Aim~     of this study is to present a novel robotic approach based on fully assisted functional~     movements and to examine the effect of the intervention in terms of motor function~     improvement in subjects with chronic stroke in the short term and at 6-month follow up. A~     preliminary evaluation of the effectiveness of the intervention in improving activity and~     participation in the short term is also performed. Further, the study aims to verify whether~     some instrumental measures (using kinematics, EMG and EEG) may help gain insight into the~     mechanisms leading to improved motor ability following the robotic intervention and can be~     used to predict functional recovery.~   "
27401|NCT03208335|"~     Hepatocellular carcinoma(HCC) is a high malignancy cancer which progress rapidly , and the~     rates of morbidity and mortality is very high in China. Radiotherapy as a effective treatment~     is commonly used in unresectable HCC patients. Preclinical models have shown that~     anti-angiogenesis medicine,such as rh-endostatin, can normalize the tumor vasculature to make~     it more efficient for oxygen delivery, which can enhance the radiosensitivity subsequently.~     This study is to evaluate the safety and efficacy of rh-endostatin combined with radiotherapy~     in the treatment of HCC.~   "
27379|NCT03208621|"~     Objective: To evaluate the impact and cost-effectiveness of FDG-PET/CT (PET) and diagnostic~     laparoscopy (DLS) in addition to initial staging by CT and gastroscopy in patients with~     advanced gastric cancer.~      Hypothesis: The study hypothesizes that performing DLS and PET for advanced gastric~     adenocarcinomas results in a reduction in the number of futile gastrectomies performed and a~     favorable cost-effectiveness. According to the literature, in 27% of patients a futile~     gastrectomy can be prevented, and the annual cost-reduction is an estimated €916.438.~      Study design: The study design is a prospective observational study. Study population: The~     study population consists of patients with a surgically resectable, advanced gastric~     adenocarcinoma (cT3-4a,N0-3,M0), that are scheduled for treatment with curative intent after~     initial staging with gastroscopy and CT.~      Usual care / comparison: Both PET and DLS were recently included in the new Dutch guidelines~     for the treatment of gastric cancer, as staging modalities for advanced (T3-4) tumors after~     initial staging. The costs of the study population will be compared to retrospective data of~     patients who underwent curative surgery (gastrectomy) after initial staging with CT alone.~      Outcome measures: The primary outcome of this study will be the proportion of patients in~     whom the PET or DLS lead to a change in treatment strategy. The accuracy of each modality~     will be analyzed separately. Secondary outcome parameters will be diagnostic performance,~     morbidity and mortality, quality of life, cost-reduction and cost-effectiveness.~      Sample size: Based on the expectation that 22% of patients will have a change in treatment~     strategy, at least 239 patients will be needed for this study to demonstrate that the~     diagnostic modalities in the new guideline are break-even. Approximately 543 patients will be~     eligible for the study in 36 months.~      Cost-effectiveness analysis: A state-of-the-art cost-effectiveness analysis and budget impact~     analysis will be performed on the additive value of PET and DLS by both prospective and~     retrospective data collection~   "
27380|NCT03208608|"~     The present cross-sectional study aims to examine the cognitive capabilities of older adults,~     aged 50 to 89, with normal hearing or age-related hearing loss by means of the Repeatable~     Battery for the Assessment of Neuropsychological Status for Hearing impaired individuals~     (RBANS-H). Secondly, the correlations between cognition on the one hand and hearing and~     speech reception capabilities on the other hand are investigated. For this purpose, twenty~     participants are included in the age categories 50 to 59, 60 to 69, 70 to 79 and 80 to 89,~     bringing the total number to 80. Three questionnaires are administered to the participants:~     the Health Utilities Index-2/3 (HUI 2/3), Dizziness Handicap Inventory (DHI) and a general~     questionnaire on education and profession, medical history, hearing aid use and tinnitus.~     Also an audiological examination is performed, including pure tone audiometry, speech in~     quiet and speech in noise audiometry. Finally, cognition is assessed using the RBANS-H.~   "
27381|NCT03208595|"~     Characterization of the female genital tract microbiome in women undergoing IVF treatment~   "
27382|NCT03208582|"~     Osteogenesis Imperfecta(OI) is an inherited disorder characterised by extreme fragility of~     the bones. Bones often break from little or no apparent cause.~      Current available medicine can increase bone strength by making bones wider and filling in~     the holes in the bone walls that weaken it. These medicines are bisphosphonates, given either~     by a drip intravenously (eg pamidronate), or taken by mouth (eg risedronate). Their major~     action is to prevent bone breakdown by stopping the normal process of removing and then~     replacing old bone tissue, so in some parts of the bone, new bone formation is actually~     reduced. Most studies of bisphosphonates in children with OI have shown increased bone~     mineral density and improved exercise tolerance that could positively affect new bone~     formation; some have shown reduced fracture rate. Bone is highly responsive to mechanical~     stimulation. Whole body vibration (WBV) is a form of mechanical stimulation that has been~     shown to improve bone mineral density in some individuals with narrow bones.~      Little is known whether bisphosphonates affect the response of the skeleton to mechanical~     stimulation. We will determine the response to mechanical stimulation in children with OI by~     looking at bone turnover markers following WBV in those who are and are not treated with~     bisphosphonates.~      The results from this study will help us to understand whether skeleton in children with OI~     is normally responsive to mechanical stimulation, and whether bisphosphonates alter that~     responsiveness in a way that is either beneficial or not for increasing bone strength.~   "
27383|NCT03208569|"~     There is increasing evidence that medications with anticholinergic effects may adversely~     affect cognitive function. Older adults are particularly sensitive to anticholinergic effects~     because of changes in pharmacokinetics and pharmacodynamics. The cumulative effect of taking~     one or more medicines with anticholinergic properties is referred to as anticholinergic~     burden. To estimate the anticholinergic burden, Boustani et al. published the Anticholinergic~     Cognitive Burden scale (2008). The objective of this study is to measure the association~     between the use of medications with anticholinergic properties (identified by the ACB scale)~     and cognitive performance. Anticholinergic use and cognitive performance will be measured at~     baseline and 6-months follow-up.~   "
27384|NCT03208556|"~     PD1 pathway is critical in determining the response to CAR T cell therapy. Emerging data~     suggested that Inhibition of PD1 could enhance the efficacy of CAR T cell therapy. iPD1 CD19~     eCAR T cells is an enhanced version of the classical 2nd generation anti-CD19~     4-1BB-costimulatory chimeric antigen receptor engineered T cells with cell-intrinsic PD1~     inhibition by incorporation of a PD1 shRNA-expressing cassette in the CAR lentivector. This~     design will enhance the anti-tumor activities of CAR T cells by inhibiting PD1 induction~     after CAR T cell activation. This pilot, single arm, one center, dose-escalation, open label~     study is to determine the safety and efficacy of iPD1 CD19 eCAR T cells in relapsed or~     refractory CD19 positive lymphoma.~      Subjects will be given a lymphodepletion chemotherapy comprised of Fludarabine and~     cyclophosphamide prior to CAR T cell infusion. The chemotherapy is completed 1 to 4 days~     before the first dost of iPD1 CD19 eCAR T cells.~   "
27385|NCT03208543|"~     This research studies the effect thermotherapy as treatment of Old World CL which is not~     invasive, non-toxic, and the short treatment. While the current standard treatment comprise~     daily painful injections with antimonials,~   "
27386|NCT03208530|"~     Test the acceptability and feasibility of a brief motivational interview intervention to~     facilitate advance care planning (ACP) conversations for older adults with serious co-morbid~     illness being discharged from the emergency department (ED). The investigators will interview~     the participants to understand their perception of the intervention and collect~     patient-reported outcomes data after leaving the ED.~   "
27402|NCT03208322|"~     The primary objective of the study is to determine the number of adverse events (AEs)~     reported by chronic hepatitis C (CHC) patients receiving at least 1 dose of daclatasvir (DCV)~     and asunaprevir (ASV) at the 2 sentinel sites and that have been reported through the Mexican~     Health Authority's AE surveillance system during a specified 24-month study period. The~     secondary objective is to describe AEs reported by CHC patients receiving treatment with DCV~     and ASV treated by doctors at participating sentinel sites for the National Pharmacovigilance~     Center (CNFV) in Mexico during a specified 24-month study period.~   "
27499|NCT03207048|"~     This study will investigate the effect of Repetitive transcranial magnetic stimulation (rTMS)~     on cognition and long-term clinical outcomes of bipolar patients.~   "
27387|NCT03208517|"~     The primary objective of this study is to determine whether a Person Centred Care online~     training programme confers significant benefit in terms of improving staff attitudes and~     quality of care of residents with dementia living in care homes, in comparison to enhanced~     usual training for professional care staff.~      There is considerable interest in e-learning and dementia from care home providers.~     Significant investment has been made into the production of resources for care staff but to~     date there appears to be no, or very limited, evaluation of their effectiveness.~      The aim is to provide a cost-effective, simple and practical evidence-based intervention,~     improving staff attitudes towards residents with dementia and quality of care provision. The~     trial will be a randomized controlled 3-arm cluster single blind trial that will take place~     over 9 months in 24 care homes in the UK.~   "
27388|NCT03208504|"~     A prospective, open-label, non-randomized, interventional clinical study, sponsored by~     Endospan Ltd. Subjects will be followed-up for five years.~   "
27389|NCT03208491|"~     The main objective of AZ@GAME ECO is to evaluate the cost-utility of the management of~     patients suffering from Alzheimer's disease using a serious game providing cognitive and~     physical straining compared to a usual management. Among the secondary objectives it is~     important to assess the real life feasibility in different types of care structures.~   "
27390|NCT03208478|"~     Nerve blocks are used to provide pain control after moderately painful orthopedic surgeries.~     Anterior Cruciate Ligament (ACL) reconstruction with patellar autograft is a painful~     orthopedic procedure performed after traumatic injury to the knee. Many patients undergoing~     ACL reconstruction receive a nerve block as part of their anesthetic care. These blocks can~     be performed in different locations along the femoral nerve, with advantages and~     disadvantages to each location. Recently published evidence indicates that there is no~     short-term difference in pain control between the two commonly-targeted locations (Adductor~     Canal and Femoral). However, studies involving patients undergoing total knee arthroplasty~     indicate that femoral blocks provide better pain control with movement than adductor canal~     blocks. As many patients undergoing ACL reconstruction use continuous passive motion (CPM)~     machines as part of rehabilitation starting on post-operative day one, the investigators~     hypothesize that pain control and quality of recovery in the first 48 hours after surgery~     will be superior with a continuous femoral block than with a continuous adductor canal block.~     The investigators plan to study this by randomizing patients presenting for ACL~     reconstruction to receive either a continuous femoral or continuous adductor canal block~     (both considered adequate means of pain control), and following them to 48 hours to determine~     the level of pain, quality of recovery score, opioid use, and CPM compliance.~   "
27391|NCT03208465|"~     This trial evaluates the effects of Empagliflozin versus Sitagliptin, in addition to standard~     of care, on global myocardial perfusion reserve using dynamic single-photon emission computed~     tomography (SPECT) images.~   "
27392|NCT03208452|"~     To evaluate the correlation between the effect of intraoperative magnesium sulfate infusion~     and the incidence of emergence agitation after pediatric ophthalmic surgery~   "
27393|NCT03208439|"~     A new electromyography (EMG)-driven neuromuscular electrical stimulation (NMES)-cycling~     system is introduced to stroke survivors for lower-limb rehabilitation. The system will~     generate NMES to targeted muscle according to the user's voluntary intention, represented by~     the EMG signal during cycling.~   "
27394|NCT03208426|"~     Objectives: A recent randomized trial showed that 14-day sequential therapy containing high~     dose proton pump inhibitor was higher than 95% in the first line treatment. However, whether~     the 14-day sequential therapy is more effective than 10-day bismuth quadruple therapy remains~     unknown. Therefore, the investigators aimed to compare the eradication rates and long term~     re-infection rates of sequential therapy for 14 days versus bismuth quadruple therapy for 10~     days in the second line treatment.~   "
27395|NCT03208413|"~     Purpose: This phase II clinical trial aims to evaluate the indications, therapeutic effects~     and side effects of thalidomide in radiation-induced brain injury.~      Further study details as provided by Sun Yat-sen Memorial Hospital, Sun Yat-sen University /~     Yameitang.~      Primary outcome measure: The primary endpoint is the brain injury remission at week 15. In~     brief, the brain lesion will be evaluated by using brain MRI scan before and after~     thalidomide regimen. The clinical efficacy is defined as ≥ 25% reduction in brain edema~     volume on FLAIR images at week 15, as compared with that before thalidomide usage.~   "
27396|NCT03208400|"~     While knowledge on the neurobiological signatures of fear and anxiety disorders and, in~     particular, their association with treatment outcome is accumulating, clinical translation~     still awaits empirical proof of evidence. Exposure-based cognitive-behavioral therapy (CBT)~     is a first-line treatment, but clinically significant change is only seen in approx. 50-65%~     of patients. Patient stratification is a powerful option to increase treatment response;~     however, developing prognostic markers suitable for single-patient predictions still is in~     its infancy and crucially requires external cross-validation embedded within an a priori~     prediction approach - a procedure yet largely missing in the field of biomarker research.~     Employing a bicentric strategy the aim of this study is to test the hypothesis that a priori~     prediction of treatment outcome based on neurobiological measures is possible in a second,~     independent sample. Building upon findings from previous mechanistic studies, These will be~     incorporated into the development of a predictive pattern comprising fear-relevant genotypes~     and molecules targeting neuropeptides, related epigenetic signatures as well as~     neurofunctional activation patterns associated with fear circuitry functions, and clinical~     data. Pre-treatment neurobiological signatures will be tested for their potential as a~     predictive response marker towards behavioral exposure (virtual reality exposure treatment~     (VRET) and an in vivo behavioral avoidance test) in a model disorder of fear circuitry~     dysfunctions (spider phobia). Multivariate pattern analyses employing a machine learning~     framework will be used to generate predictions on the individual patient level and to~     cross-validate markers in a second, independent sample. While at site A predictions will be~     generated following completion of the treatment, response will be predicted at site B a~     priori, but in a double-blind manner. Comparison of observed vs. predicted response rates~     will serve as a test of hypothesis. In addition, neuroplastic (on a subsample) and epigenetic~     changes induced by VRET treatment will be assessed following treatment and, in case of~     epigenetics, also after 6-months follow-up.~   "
27397|NCT03208387|"~     The goal of this study is to learn about the cognitive and behavioral functioning of children~     being treated for cancer.~   "
27398|NCT03208374|"~     This study will recruit approximately 5,000 patients with histologically confirmed cancer who~     have successfully completed MSK-IMPACT panel testing and collect information about tumor~     genetic results and patient exercise behavior history.~   "
27399|NCT03208361|"~     This study aims to evaluate wether high-dose penicillin V is as effective as high-dose~     amoxicillin for the treatment of non-sever community-acquired pneumonia (CAP).~   "
48021|NCT02938351|"~     The aims of the present study will be to pilot test the efficacy of a collaborative care~     intervention in patients awaiting kidney transplant to reduce symptoms of depression, pain,~     fatigue and improve quality of life.~   "
27403|NCT03208309|"~     Considering that, Diacerein is on the market for 16 years being used continuously in elderly~     patients with osteoarthritis without experience significant side effects, and considering the~     anti-hyperglycemic effect and the improvement in the insulin resistance observed in animal~     models of type 2 diabetes treated with this medicine.~      The aim of this study is to investigate the effect of Diacerein, a medication with~     anti-osteoarthritic properties and moderately analgesic activity, anti-inflammatory and~     antipyretic, which demonstrates inhibit properties for the synthesis of pro-inflammatory~     cytokines such as interleukin 1 (IL-1). Administered for 12 weeks and the effect in the~     glycemic and metabolic control in patients with diabetes mellitus 2 and secondary failure to~     metformin treatment.~   "
27404|NCT03208296|"~     The primary objective is to confirm the safety of treating multiple BCCs once weekly x 3~     weeks in individuals with Basal Cell Nevus Syndrome (BCNS).~      The secondary objectives of the study are to obtain preliminary data on the effectiveness of~     ASN-002 in the treatment of BCCs in individuals with Basal Cell Nevus Syndrome (BCNS) by~        1. evaluating the histological clearance of BCCs in patients with BCNS, and~        2. assessing the clinical changes of BCCs after treatment with ASN-002, and~        3. assessing the systemic effect of ASN-002 by determining response in non-injected lesions~        4. assess the safety and clinical changes after a second cycle of ASN-002 injections~   "
27405|NCT03208283|"~     Colonoscopy is a sedated procedure traditionally performed using air insufflation during the~     insertion phase of the procedure. Recently, the use of water method (eg, water infusion or~     water exchange techniques) during the insertion phase of colonoscopy has been reported to~     increase the proportion of patients in whom complete unsedated colonoscopy could be achieved,~     reduce patient recovery time burdens, decrease abdominal discomfort during and after~     colonoscopy, enhance cecal intubation, and increase willingness to repeat an unsedated~     colonoscopy. However, there has been no study on the use of water method during the training~     of primary care doctors or nurse endoscopists in flexible sigmoidoscopy for colorectal cancer~     screening.~      In unsedated endoscopic procedure such as FS, endoscope insertion techniques that can~     potentially reduce patient discomfort and increase the rate of achieving an adequate depth of~     scope insertion are desirable. Our current study aims to evaluate the impact of water method~     during insertion phase of FS in the training of primary care doctors or nurse endoscopists~     for colorectal cancer screening.~   "
27406|NCT03208270|"~     Bleeding is the most feared complication during extracorporeal membrane oxygenation (ECMO)~     and is associated with high dosing of heparin. There is no consensus on antithrombin (AT)~     supplementation during ECMO. However, AT is needed by heparin to properly anticoagulate. We~     hypothesize that maintaining normal antithrombin levels during ECMO is associated with a less~     heparin dosing and more adequate level of anticoagulation.~   "
27407|NCT03208257|"~     Septic shock is a common syndrome caused by the body's response to an infection. Septic shock~     is responsible for 10% of all ICU admissions and 30% of ICU deaths. Use of beta blocker~     medications may improve outcomes after septic shock. This pilot study evaluates protocols to~     infuse the beta blocker esmolol in patients with septic shock.~   "
27408|NCT03208244|"~     This is a proof of concept, single center study for the donation of HCV-positive hearts to~     HCV negative recipient patients, with preemptive, interventional treatment with 12 weeks of~     commercially available DAA therapy to prevent HCV transmission upon transplantation.~   "
27409|NCT03208231|"~     The purpose of this study is to evaluate the safety and antiviral activity of VRC01 in~     HIV-1-infected infants beginning combination antiretroviral therapy (cART).~   "
27410|NCT03208218|"~     The purpose of this study is to evaluate the pharmacokinetics equivalence and safety by~     comparing pharmacokinetics characteristics between the SYP-1512 Tab and Revlimid cap (25mg)~     when administered a single-dose to healthy male volunteers.~   "
27411|NCT03208205|"~     The aim of this study is to report outcomes of pars plana vitrectomy (PPV) in pediatric~     retinal detachment (RD) accompanied with proliferative vitreoretinopathy (PVR) as well as~     complications and factors influencing the final anatomical and functional results.~      This is retrospective consecutive case series of 14 eyes treated with primary PPV for RD~     repair. Average postoperative follow-up period is 34 months.~   "
27412|NCT03208192|"~     Background: until now, there is no agreement about the safest and feasible method for liver~     parenchyma transection during laparoscopic liver resection.~      Study design: prospective, randomized, single-center The purpose of the study: comparison of~     short-term results of two methods of parenchyma liver transection during laparoscopic liver~     resection~   "
27413|NCT03208179|"~     This study evaluates the efficacy and safety of monthly intermittent preventive treatment~     using dihydroartemisinin piperaquine (DP) alone or in combination with azithromycin (AZ)~     compared to sulphadoxine-pyrimthamine (SP) for the prevention of malaria in pregnant women in~     the second and third trimester.~   "
27414|NCT03208166|"~     The purpose of this study is to determine the effects of the Doctormate device, a specialized~     blood pressure cuff used to perform remote limb ischemic conditioning, on cerebral blood flow~     in subjects with intracranial atherosclerosis. Previous studies in patients with narrowing of~     the brain arteries have shown that this device is safe to use and suggested that if this~     device is inflated in both arms for 5 minutes, followed by deflation for 5 minutes and~     repeated 4 times in a row every day for 6-9 months, the risk of another stroke is lowered and~     the device may increase the blood flow to the brain.~   "
27415|NCT03208153|"~     The role of a routine invasive strategy in frail patients with non-ST-segment elevation acute~     myocardial infarction is currently uncertain. We hypothesize that a routine invasive strategy~     will improve outcomes. The aim of the trial is to evaluate the efficacy and safety of a~     routine invasive strategy in increasing the number of days alive at home during the first~     year and improving cardiovascular outcomes.~   "
27432|NCT03207919|"~     This study will evaluate the potential impact of a brief musical intervention, the Lullaby~     Project, in a sample of pregnant women. The study aims are:~        1. To determine the potential effect of the Lullaby Project on maternal-fetal attachment.~        2. To evaluate the potential impact of the Lullaby Project on maternal mental health.~        3. To characterize the potential impact of the Lullaby Project on perceived maternal~          stress.~   "
32399|NCT03142958|"~     A post market, prospective, non-randomized, multi-center, open-label,clinical study using~     survivorship as the reference performance goal to study the safety and efficacy of the~     Cadence Total Ankle System (TAS) when used for primary ankle arthroplasty.~   "
27416|NCT03208140|"~     Assessment of the airway forms part of routine anesthetic practice. However, the predictions~     referred to intubation or ventilation difficulties are usually inconclusive. In effect, the~     failure rate in predicting such difficulties exceeds 60%. In this scenario it is not possible~     to know whether a given patient will be difficult to intubate and ventilate. These are~     referred to as non-intubate and non-ventilate cases with a high risk of severe neurological~     complications and even death due to hypoxemia. According to all the clinical guides, the~     solution in such cases usually involves the use of supraglottic devices that rescue~     oxygenation through effective ventilation.~      In the event of ventilation failure with a supraglottic device, it is currently not possible~     to know whether the device is correctly positioned, unless some other instrument such as a~     flexible fiberscope is used to visualize the anatomy beyond the ventilation device.~      The TotalTrack is a new device with all the characteristics of a supraglottic device that~     moreover includes a camera at the tip, allowing us to confirm anatomical positioning with~     respect to the glottic structures. This device also allows intubation under indirect~     visualization of the glottis, thus adding the possibility of definitive patient lung~     isolation.~      The primary objective of this study is to determine the capacity to visualize the glottic~     structures through the camera of the TotalTrack device, compared with glottic visualization~     afforded by indirect laryngoscopy in the same patient. The Cormack-Lehane scale and~     percentage of glottic opening (POGO) are used for this purpose.~      The secondary objectives comprise assessment of the ventilation, intubation and TotalTrack~     device withdrawal times. The hemodynamic changes associated to both techniques during~     intubation and TotalTrack device withdrawal are also evaluated. Minimum patient oxygenation~     throughout the procedure is assessed. The sealing and ventilation pressures during operation~     of the TotalTrack device are recorded. Likewise, an analysis is made of the number of~     placement attempts, visualization improvement maneuvers, and minor complications associated~     to the use of the TotalTrack device (presence of blood upon withdrawal or pharyngeal pain),~     with their degree of severity.~   "
27417|NCT03208127|"~     This is a single center study for the donation of HCV-positive livers to HCV negative~     recipient patients, with preemptive, interventional treatment to prevent HCV transmission~     upon transplantation.~   "
27418|NCT03208114|"~     Background: Although exclusively breastfeeding is recommended up to six months, current~     breastfeeding rates are still far from recommended targets. The investigators aim to~     investigate the effect of the information on breast milk substitutes at discharge on~     breastfeeding rates at six months of age.~      Methods: A randomized controlled trial has been designed. All mother-infant pairs will be~     randomized to either receive the written information of the name of a breast milk substitute~     on the infant's discharge documents (group A) or not to receive it (group B). Mothers will~     receive a phone interview on mode of infants' feeding at 7 days,1, 2 , 3 and 6 months after~     delivery. Reasons for early discontinuation of breastfeeding according to mothers' opinion~     will be also collected.~      Statistical analysis:~      Sample size: In order to detect a 10% difference in the discontinuation rate of exclusive~     breastfeeding at six months of age between groups, at 5% significance and 80% power, a total~     of 388 mother-infant pairs per group will need.~      Descriptive data will be expressed as mean±SD or number of observations (percentage). With~     regard to the items that were scored on a 5-point Likert scale, for the analysis, the answers~     will categorize into two groups (not important and important).~      Differences between groups in breastfeeding rates at each time point of the study will be~     assessed by the T-test analysis. The X2 test will be used for comparisons between discrete~     variables. Statistical significance is set at a = .05 level. All statistical analyses will be~     performed by using SPSS (version 12, SPSS, Chicago, IL).~   "
27419|NCT03208101|"~     This is a single-center, randomized, active-controlled, parallel-group, open-label, phase I~     study to evaluate safety and immunogenicity of single injection of LBVD or Eupenta~     co-administered with Imovax Polio in healthy adults.~   "
27420|NCT03208075|"~     The investigators have conducted the study about the effects of normal diet and~     low-phosphorus diet on phosphorus homeostasis in healthy subjects, now this study is designed~     to explore further about the effect of high-phosphorus diet on phosphorus homeostasis.~   "
27421|NCT03208062|"~     Musculoskeletal disorders are an heterogeneous group of diseases that represent one of the~     major causes of disability. Considering the importance of studying these pathologies, it is~     necessary to develop research lines based on the availability of human biological material~     from highly clinically relevant patients. The purpose of this project is therefore the~     establishment of a bank of biological material (biobank) to investigate important aspects~     related to the pathologies of the musculoskeletal system through subsequent bio-molecular~     characterization studies.~   "
27422|NCT03208049|"~     The purpose of this study is to evaluate the efficacy and effectiveness of sleep restriction~     (SR) and cognitive therapy (CT) in Gulf War Veterans with insomnia.~      The primary hypothesis is that the efficacy of these treatments will depend upon an~     individual subject's baseline characteristics. For SR we expect that baseline measures of~     excessive time spent in bed may predict response and for CT we expect that baseline~     measures of cognitive arousal and pain may predict response. Exploratory analyses using~     signal detection techniques will systematically compare and contrast the potential usefulness~     of a number of additional potential moderator measures.~      Insomnia is a serious health problem in Gulf War Veterans that is often associated with~     extensive prescription of sleeping medications. Although safer, even the latest sleeping~     pills can lead to cognitive impairment and risk of abuse. Thus non-pharmacological~     treatments for insomnia have been pursued as alternatives to medications. Cognitive Behavior~     Therapy for Insomnia (CBT-I) is the term widely used to describe therapies that combine~     behavioral and cognitive therapies for insomnia. The combined CBT-I approach has~     well-documented efficacy. Between 2012 and 2014 over 650 VA mental health clinicians have~     received extensive training in CBT-I. Although CBT-I is efficacious, the optimal target~     populations for its major components has not yet been well-defined for Gulf War Veterans. We~     propose to address this gap and develop tools for clinicians to identify the best treatment~     for insomnia for individual Gulf War Veterans.~   "
27423|NCT03208036|"~     Development of interventions that can effectively target and remediate the cognitive and~     functional impairment associated with schizophrenia is a treatment priority. Transcranial~     direct current stimulation (tDCS) is a safe, non-invasive neuromodulation technique that is~     capable of stimulating brain activity to facilitate learning. The primary objective of this~     study is to evaluate the pairing of two therapeutic techniques, cognitive remediation and~     tDCS, as a cognitively enhancing intervention. This study is designed to address four~     questions. Is cognitive remediation paired with tDCS more efficacious than cognitive~     remediation delivered with sham stimulation? Is it possible to predict responsiveness to the~     intervention? Is intervention-induced cognitive change sustainable? Are there barriers to~     implementing this intervention in clinical practice?~      To examine the incremental benefit of pairing tDCS with cognitive remediation, a 110~     clinically stable outpatients between the ages of 18-60 who have a diagnosis of schizophrenia~     or schizoaffective disorder will be enrolled in a double-blind, double-baseline,~     sham-controlled clinical trial. Participants will be randomized in a 1:1 ratio to receive~     either tDCS or sham stimulation concurrent with working memory focused cognitive remediation.~     Training will be offered to participants in a small group format. Training will consist of 48~     sessions, with 2-3 sessions scheduled in a week. Each training session will last 2 hours. One~     hour will be spent completing cognitive exercises that require working memory skills on a~     computer. TDCS or sham stimulation will be offered concurrent with the first 20 minutes of~     training with a StarStim neuromodulator. One mA of anodal stimulation will be applied to the~     left dorsal lateral prefrontal cortex and the cathodal electrode will be placed in the~     contralateral supraorbital position. Upon completion of working memory training, participants~     will transition to a 30-minute discussion group. The discussion will focus on application of~     cognitive skills in everyday life. Effective strategies for approaching cognitive tasks will~     be described and practiced. Participant experience with aspects of the training will be~     monitored with self-report measures of motivation, mood, and physical reactions. To assess~     intervention-induced change, working memory, other aspects of cognition, functional capacity,~     and community functioning will be assessed pre- and post-intervention. Cognitive outcomes~     will be assessed with training tasks as well as tasks that are unfamiliar to participants. A~     performance-based measure will be used to assess functional capacity for everyday living~     skills and a self-report instrument will be used to assess community functioning. Potential~     confounds such as symptom severity, medication changes, outside treatment hours, and~     significant life stressors will be assessed individually every 2 weeks during the~     intervention phase of the study. Sustainability of intervention-induced change will be~     assessed with assessment sessions 6 weeks and 6 months post-intervention. Change in~     performance during the first 12 training sessions on two working memory training tasks, a~     n-back task and a complex span task, will be used to determine if early response to treatment~     is predictive of post-intervention outcomes. An intent-to-treat analysis will be used to~     analyze intervention-induced change. Regression analyses will be conducted to identify~     predictors of treatment response.~      Achieving the proposed objectives will yield important information about the efficacy,~     durability, and efficiency of a novel pairing of cognitively enhancing interventions.~     Findings will inform treatment development for patients with schizophrenia as well for~     patients with other cognitively compromising illnesses.~   "
27424|NCT03208023|"~     This study aims to evaluate the effect of a novel hemodynamic management and monitoring~     strategy for reducing cardiac bio marker elevations and major adverse cardiac events.~   "
27425|NCT03208010|"~     The purpose of this study is to test a culturally tailored lifestyle intervention designed to~     prevent, or delay onset of, T2DM in Mexican Americans with prediabetes. Half the participants~     take part in a lifestyle program that emphasizes preparing and eating healthy~     Mexican-American foods and increasing physical activity and the other half will take part in~     an enhanced usual care control group.~   "
27433|NCT03207906|"~     Paronychia is inflammation of the skin surrounding the nail that leads to secondary~     infection. Iatrogenic paronychia has been clearly associated with cancer chemotherapies. This~     phase-2 trial is a dose finding study and will evaluate topical VBP-926 solution against a~     vehicle control.~   "
27434|NCT03207893|"~     The purpose of this study is to determine if the use of continuous glucose monitoring with~     the GEM lifestyle modification program (Glycemic load, Exercise and Monitoring glucose) will~     result in better diabetes control than routine care.~   "
27426|NCT03207997|"~     Assessment of pulmonary fibrosis is currently based on high-resolution CT (HRCT) and~     pulmonary function tests (PFT) such as forced vital capacity, (FVC) and carbon monoxide~     diffusion (DLCO). These techniques allow a semi-quantitative analysis of the pulmonary~     disease but are imperfect. The mains weaknesses are the lack of reproducibility, the limited~     sensitivity and for CT the resulting radiation dose.~      Recent advances in MRI sequences allow exploring the lung parenchyma with millimeter slice~     thickness. Development of computer-assisted post-processing such as elastic registration~     opens new perspectives in the functional study of the lung parenchyma, especially the~     analysis of its deformation during the respiratory cycle and therefore of its elasticity.~      Pulmonary involvement in scleroderma is present in 70 to 100% of patients and is the leading~     cause of death. Initial assessment of pulmonary involvement and follow-up are important for~     therapeutic decisions and patient prognosis. Quantitative analysis should be developed to~     reliably evaluate pulmonary fibrosis and increase the reproducibility.~      The purpose of our study is to evaluate the feasibility of quantifying pulmonary fibrosis by~     successively performing full inspiration then full expiration volumetric MR acquisitions~     using a VIBE - Volumetric Interpolated Breath-hold examination sequence. Post processing of~     the 2 volumes using elastic registration is performed to evaluate pulmonary deformation in~     the normal and fibrotic lung areas, hypothesizing that it would be different.~   "
27427|NCT03207984|"~     Subepithelial connective tissue graft (SCTG) is considered gold standard for root coverage~     treatment. However, it is associated with postoperative morbidity, limited amount of donor~     tissue and longer surgical time. Thus, the search for a tissue substitute for SCTG is~     increasing. Currently, one of the possible autogenous soft tissue substitutes found in the~     market is the Mucograft® xenogeneic matrix (MG). The results with the use of MC are very~     promising, both for root coverage as well as for gain of keratinized tissue. The present~     study consists of a parallel randomized clinical trial with the objective of comparing SCTG~     (control group) and MG (test group) in the treatment of Miller's class I and II gingival~     recessions, multiple in aesthetic areas (upper central incisors, Lateral and canine).~   "
27428|NCT03207971|"~     Subepithelial connective tissue graft (SCTG) is considered the gold standard treatment for~     root coverage in Miller Class I and II single gingival recession. Therefore, scientific~     evidence is limited for multiple gingival recessions, only with extrapolation from~     single-tooth data. Depending on area and depth during the removal of the graft from palate,~     connective tissue presents different anatomic characteristics, geometric shapes and~     histological composition. Possibly different types of SCTGs present distinct volumetric~     stability and physiological process of revascularization. This randomized, split-mouth,~     double blind clinical trial aim to evaluate periodontal parameters (complete root coverage,~     gingival recession depth and width, gingival thickness, width of keratinized tissue, probing~     depth, clinical attachment, plaque and bleeding index) and gingival blood flow in recipient~     sites, comparing sites that received SCTG from palatal area with predominance of lamina~     propria and predominance of submucosa. Clinical measurements will be evaluated at baseline~     and 3, 6 and 12 months after surgical procedure. Blood flow flowmetry with laser doppler~     (LDF) will be analyzed at baseline and 3, 7,14 and 28 days after surgery. Participants will~     be invited to answer a questionnaire of aesthetic satisfaction and symptoms of pain and~     discomfort. Two experienced periodontists blind to experimental groups will be invited to~     observe the clinical outcomes and answer an aesthetic questionnaire. Data analysis will be~     performed by paired t-test if follow normal distribution or Wilcoxon if follow nonnormal~     distribution with significance level of 5% (p <0.05).~   "
27429|NCT03207958|"~     Given the role of B cells in the pathophysiology of chronic graft versus host disease (GvHD),~     the association between elevated BAFF levels post-transplant in abnormal B-cell homeostasis~     and chronic GvHD, and the efficacy of belimumab in the inhibition of soluble human B~     lymphocyte stimulator protein (BAFF) signaling, these proof-of-principle findings support the~     rational for use of belimumab as prophylaxis of chronic GvHD. The investigators propose a~     pilot and feasibility study to assess the safety and tolerability, as well as preliminary~     efficacy, of belimumab as prophylaxis of chronic GvHD following allogeneic hematopoietic cell~     transplantation (alloHCT). The investigators' central hypothesis is that belimumab will be~     well tolerated and have a favorable effect on incidence and severity of chronic GvHD.~   "
27430|NCT03207945|"~     Atherosclerosis in the setting of HIV infection is distinct and includes increased vascular~     inflammation, worsened endothelial function, and a predominance of non-calcified plaque.~     These outcomes can be assessed using specialized noninvasive imaging which strongly predict~     future CV events in the general population.~      PCSK9 has emerged as an important pharmacologic target for cholesterol lowering in the~     general population and recent studies among individuals without HIV have shown that PCSK9~     inhibitor therapy is safely tolerated and significantly reduces major CV events in the~     general population.~      The investigators will perform a clinical trial of PCSK9 inhibition in the setting of HIV~     infection. This will be a randomized, placebo-controlled study to evaluate the effects of~     PCSK9 inhibition on vascular inflammation, endothelial function, and non-calcified plaque~     using a PCSK9 inhibitor called alirocumab. This study will recruit 140 treated individuals~     with HIV who are aged 40 and older, with known CVD or risk factors for CVD and who have~     evidence of vascular inflammation at baseline.~      The primary and secondary objective of this study is to determine whether PCSK9 inhibition~     can improve arterial inflammation as assessed by FDG-PET/CT and endothelial function as~     assessed by flow mediated vasodilation. The investigators will correlate changes in arterial~     inflammation and endothelial function with lipids and markers of inflammation and immune~     activation.~      The tertiary objective is to perform a pilot evaluation of the impact of PCSK9 inhibition on~     non-calcified plaque as measured by coronary CT angiography. Non-calcified plaque~     measurements will be correlated with changes in lipid parameters and markers of inflammation~     and immune activation.~   "
27431|NCT03207932|"~     anatomical landmarks on the body surface were used to insert central vein catheter. However,~     ultrasound technique is emerging as a new technique for vein catheterisation. For subclavian~     and femoral vein catheterisation, up to now, there is a lack of evidence of the superiority~     of one technique over the other.~   "
27470|NCT03207425|"~     This is a study to characterize the pharmacokinetics as well as safety and tolerability of a~     single oral dose of EDP-305 in subjects with mild and moderate hepatic impairment compared to~     matched healthy subjects.~   "
27435|NCT03207880|"~     Serial use of urine multi-level pregnancy tests (MLPTs) has been shown to be a reliable and~     efficient strategy for excluding ongoing pregnancy after medical abortion at ≤ 63 days of~     gestation. This pilot project will assess whether MLPTs can enhance the quality of remote~     medical abortion services through enabling women to reliably ascertain their abortion~     outcomes at home sooner than would otherwise have been the case.~      safe2choose provides remote medical abortion services through the Internet (information,~     counselling and access to abortion pills) in a growing number of countries worldwide.~     safe2choose will collaborate with Gynuity Health Projects to pilot the utility of MLPTs for~     home follow-up as part of its remote medical abortion services.~      As safe2choose does not have a physical office, the location of the sponsor's office is~     listed in this entry as the study location. Women from the United States are NOT eligible to~     enroll.~   "
27436|NCT03207867|"~     The purpose of this phase 2 study is to evaluate the efficacy and safety of NIR178 in~     combination with PDR001 in multiple solid tumors and diffuse large B-cell lymphoma (DLBCL)~     and further explore schedule variations of NIR178 to optimize immune activation through~     inhibition of A2aR.~   "
27437|NCT03207854|"~     This research trial collects and stores blood, tissue, and bone marrow specimens from~     patients with cancer or blood disorders, and healthy volunteers to study the immune system in~     a variety of different types of experiments, as well as associated clinical data as~     appropriate, focused on understanding mechanisms of immunotherapy.~   "
27438|NCT03207841|"~     Individuals with spinal cord injury (SCI) are living to ages when metabolic disorders are~     highly prevalent. The combination of impaired glucose tolerance and insulin resistance can~     disrupt lipid metabolism and increase the risk of cardiovascular disease and diabetes, and~     contribute to an accelerated aging process in the SCI population. Feasible interventions to~     improve metabolic function in the chronic SCI are in great demand. Compared to pharmacologic~     therapies, dietary modification is a more cost-effective treatment option for reducing the~     risk of metabolic dysfunction that, surprisingly, has not been rigorously investigated in~     people with SCI. Therefore, in the present study the investigators will investigate the~     efficacy of an 8-week, eucaloric (a meal plan designed specifically to provide the exact~     amount of calories needed to maintain a given body weight) LC-HP dietary intervention for~     improving metabolic function, body composition, gut bacteria composition and quality of life~     in individuals with SCI and impaired glucose tolerance or type 2 diabetes. The investigators~     also aim to determine the association between changes in the composition of gut bacteria and~     improvements in metabolic function and the association between improvements in metabolic~     function and improvements in quality of life.~   "
27439|NCT03207828|"~     Chronic pain is a major health problem. It causes high economic and social costs around the~     world and severely impairs the quality of life of those who suffer from it. Chronic pain and~     major depression frequently co-occur. Patients with both conditions have a worse prognosis~     and higher disability, and their treatment options are scarce. Behavioral activation (BA) may~     be an especially useful intervention for these patients. This intervention targets mechanisms~     of action that seem to be common to both disorders. In spite of this, the efficacy of this~     intervention has not been yet examined in people with both conditions. Therefore, the purpose~     of the present study is to examine the efficacy of BA compared to usual care among Chilean~     women with fibromyalgia and mayor depression (N = 90). Women will be randomized to an~     experimental arm (n = 45) who will receive usual care (UC) for fibromyalgia with comorbid~     depression plus BA; and a comparison arm, who will receive only UC for fibromyalgia with~     comorbid depression (n =45). Primary and secondary outcomes will be assessed before, during,~     and after the intervention, as well as at a three month follow-up. The investigators expect~     to find that, after treatment, the group receiving BA will experience higher statistical and~     clinical significant reductions in depressive symptom severity (primary outcome), as well as~     in their levels of some pain-related variables (namely pain intensity, fibromyalgia impact,~     pain-related anxiety, catastrophism, and physical health symptoms severity). In addition, the~     percentage of women in remission from the diagnosis of depression (as well as the percentage~     of women responding to treatment) will be greater in the experimental arm than in the~     comparison arm. Also, the percentage of women who show a clinically significant reduction in~     pain intensity (decreases greater than two units in the pain intensity scale) will be greater~     in the experimental arm than in the comparison arm. Finally, the investigators hypothesize~     that the decrease observed in the pain-related variables will be mediated by the decrease~     observed in depressive symptoms severity. Regarding the outcomes assessed at a three months~     follow-up, the investigators expect to find that the differences found after treatment~     between the two arms will be maintained at follow-up. In order to test our hypothesis,~     Hierarchical Linear Models (HLM) and Cochran-Mantel-Haenszel tests will be performed. The~     results of these study might contribute to facilitate the integrated treatment of~     fibromyalgia and depression, and to reduce the burden on the health system due to the lack of~     effective therapeutic strategies to treat these comorbidity.~   "
27440|NCT03207815|"~     The primary objective of this study is to evaluate the efficacy of filgotinib versus placebo~     for the treatment of the signs and symptoms of noninfectious uveitis in participants failing~     treatment for active noninfectious uveitis.~   "
27441|NCT03207802|"~     Study will collect data from the home using the CoVa Monitoring System. Data will be captured~     and retrospectively analysis to determine if the data provided can alert clinician about a~     patient's declining health.~   "
27442|NCT03207789|"~     The designed study follows up on the previous one by the international T-cell project (Bellei~     et al,, 2012) and its purpose is to verify whether a prospective collection of data would~     permit access to more accurate information permitting a better definition of prognosis and~     investigation of more adequate treatment strategies for these neoplasms.~      The analysis of patients distributed in all five macro regions of the country and a~     comparison among them will provide a real picture of the disease in Brazil, limiting the bias~     probably found in the previous projects.~   "
27443|NCT03207776|"~     Patients who are hospitalized at select Carolinas Healthcare System (CHS) sites with Chronic~     Obstructive Pulmonary Disorder (COPD) acute exacerbation symptoms will be treated per the CHS~     COPD Clinical Pathway. Patient outcomes will be followed, including but not limited to~     readmission. Patients on the pathway will also have access to navigator services.~   "
27444|NCT03207763|"~     Microneedles can be prepared as a low-cost patch that is simple for patients to apply for~     vaccine delivery targeting the many antigen-presenting cells present in the skin. Data~     regarding the safety, reactogenicity, tolerability, and acceptability of a microneedle patch~     in children are lacking. The goal of this study is to evaluate the safety, reactogenicity,~     and acceptability of placement of a placebo microneedle patch to the skin of children.~   "
27445|NCT03207750|"~     The purpose of this study is to assess if there is any immune interference between the~     Porcine circovirus free (PCV-free) liquid Human rotavirus (HRV) vaccine and routine infant~     vaccinations currently in use in the US, namely Pediarix®, Hiberix® and Prevenar 13® as~     compared to the currently licensed lyophilized formulation of the HRV vaccine when~     co-administered with the same routine vaccinations in healthy infants 6-12 weeks of age~   "
27471|NCT03207412|"~     This project will investigate the safety and effectiveness of human amniotic epithelial cells~     in primary ovarian insufficiency patients and provide a new cell therapy against infertility.~   "
27446|NCT03207737|"~     The purpose of this study is to examine the effects of onsite and telehealth programs for~     individuals with spinal cord injury. The primary aim of this study is to compare the~     effectiveness of a blended 7-day onsite health promotion program followed by a 12-month~     telehealth package composed of exercise, nutrition, and mindfulness, to a 12-month~     telehealth-only package in individuals with spinal cord injury. The investigators hypothesize~     that the blended onsite and telehealth program will achieve better gains in fitness, dietary~     control, body composition, and pain management scores across a one-year period in comparison~     to the telehealth-only group. The secondary objective of this study is to examine changes in~     psychosocial mediators between the two groups to determine if key social cognitive theory~     constructs were significantly different between the two groups. The investigators hypothesize~     that the blended onsite and telehealth program will achieve better improvements in these~     outcomes compared to the telehealth only group.~   "
27447|NCT03207724|"~     This study is being conducted to examine the safety of the investigational drug, Xilonix(™),~     in addition to standard doses of Onivyde® (nanoliposomal irinotecan) and 5- fluorouracil~     (5FU)/folinic acid (leucovorin) for pancreatic cancer patients with cachexia. Cachexia is a~     syndrome that includes involuntary weight loss and physical deterioration that can contribute~     to poor outcomes of cancer treatment. In other studies, Xilonix has increased lean body mass~     in advanced cancer patients. This increase could lead to improved weight maintenance and~     quality of life.~   "
27448|NCT03207711|"~     Type 2 diabetes mellitus (T2DM) is the most expensive chronic disease in the U.S.~      Lifestyle modification is central to T2DM management, but long-term adherence to dietary~     recommendations is difficult. A key challenge is the difficulty of coping with cravings for~     high carbohydrate or sugar-laden foods in an environment where these foods are tempting and~     widely available. One mechanism by which mindfulness may increase long-term dietary adherence~     is by better equipping individuals with skills to experience food cravings and difficult~     emotions without eating in response. Such approaches seek to strengthen abilities to be~     non-judgmentally aware of, tolerate, and respond skillfully to food cravings and difficult~     emotions without reacting impulsively or maladaptively. The investigators hypothesize that~     improved ability to manage food cravings and emotional eating is a key mechanism through~     which mindfulness-enhancements can improve dietary adherence. The study will test a~     mindfulness-based intervention (MBI) for improving dietary adherence. Although the particular~     diet employed is not the focus of this study, the study will use a diet with about 10% of~     calories from carbohydrate as: (1) it induces a low level of ketone production, which will be~     used as a biomarker for dietary adherence; (2) prior studies suggest it improves metabolic~     parameters in T2DM, including glycemic control.~   "
27449|NCT03207698|"~     The aim of the present trial is to evaluate the efficacy of PRF with 1% MF in treatment of~     mandibular class II furcation defects and its comparison to PRF and access therapy alone.~   "
27450|NCT03207685|"~     To demonstrate safety and effectiveness of the Embrace device in identifying convulsive~     seizures (CS) and notifying a caregiver during patient hospitalization at an epilepsy~     monitoring unit (EMU).~   "
27451|NCT03207672|"~     This study is conducted to determine the maximum tolerated dose (MTD) of E7389 liposomal~     formulation (E7389-LF).~   "
27452|NCT03207659|"~     The investigators aim to perform a prospective and randomized trial comparing the safety and~     efficacy of active basket extraction of fragments and stone dusting during the RIRS.~   "
27453|NCT03207646|"~     This study evaluates a smartphone-based cardiac rehabilitation program in adults with~     coronary artery disease. Half of patients will participate in a smartphone-based cardiac~     rehabilitation program while the other half will receive standard-of-care.~   "
27454|NCT03207633|"~     This study aims to evaluate the therapeutic effect of low frequency rTMS over the right~     DLPFC, versus right OFC versus Sham group of obsessive-compulsive disorder (OCD) patients.~     Sixty patients will be recruited from the out-patient psychiatric clinic of a university~     hospital, and randomized into three equal groups. The 1st group will receive 10 sessions of~     low frequency rTMS targeting right DLPFC by means of a butterfly coil, 120% RMT, 1 Hz, 3~     trains, each of 500 pulses with a 40 seconds inter-train interval allowing the coil to cool.~     The 2nd group will receive 10 sessions of low-frequency rTMS over the right orbitofrontal~     cortex (OFC), the international 10-20 EEG system will be used to position the coil over the~     right OFC, at the right frontopolar 2 (Fp2) electrode site, using the following parameters:~     120% motor threshold, 1 Hz, 3 trains, each of 500 pulses with a 40 seconds inter-train~     interval allowing the coil to cool. The 3rd group will receive sham stimulations with the~     same pulse delivery as the other groups but with the coil placed perpendicular to the scalp.~      The resting motor threshold (RMT) and cortical silent period (CSP) at different intensities~     from 110 % to 150 % will be measured before and after the end of sessions. All assessments~     like (Y-BOCS), (HAM-A), Beck Depression Inventory, (CGI-S), (MoCA) will be performed before~     and after end of the sessions and 3 months later.~   "
27455|NCT03207620|"~     Smoking occurs frequently in patients with asthma. Recent surveys on smoking prevalence~     report 21-26% current smokers in populations of patients with asthma. Detrimental effects of~     active smoking in asthma include worse asthma control, an impaired response to~     corticosteroids and accelerated lung function decline.~   "
27456|NCT03207607|"~     The purpose of this study was to determine the effect of mid-morning gel snacks on subjective~     appetite, glucose and insulin responses, and food intake in healthy weight young adults.~   "
27457|NCT03207594|"~     The purpose of this study is to improve cancer care and the delivery of cancer care.~     Researchers are interested in studying patient reported information and examining how~     different factors may impact cancer care.~   "
27458|NCT03207581|"~     The study will assess the effect of individualized professional coaching for mid-career~     family medicine and general internal medicine physicians on burnout, job satisfaction, and~     professional fulfillment.~   "
27459|NCT03207568|"~     The objective of the study is to evaluate the safety and performance of Relay Pro and Relay~     NBS Pro devices in humans having thoracic aortic pathologies.~      Clinical results will be used to apply for the CE certification.~   "
27472|NCT03207399|"~     The purpose of this study is to evaluate whether treatment with Epclusa~     (sofosbuvir/velpatasvir) after lung transplantation in individuals with chronic hepatitis C~     infection is feasible, safe and effective at curing HCV.~   "
27460|NCT03207555|"~     The standard approach to managing chronic lymphocytic leukemia (CLL) and small lymphocytic~     leukemia (SLL) is to wait until you have symptoms before treatment is given.~      The goal of this clinical research study is to learn if providing earlier treatment for CLL~     or SLL with ibrutinib in patients who do not have symptoms will be more effective than~     waiting until symptoms develop.~      This is an investigational study. Ibrutinib is FDA approved and commercially available for~     the treatment of patients with CLL or SLL. It is considered investigational to give ibrutinib~     to CLL and SLL patients before symptoms develop.~      The study doctor can describe how the study drug is designed to work.~      Up to 50 participants will be enrolled in this study. All will take part at MD Anderson.~   "
27461|NCT03207542|"~     The goal of this clinical research study is to learn if daratumumab can help to control B- or~     T-cell acute lymphoblastic leukemia (ALL). The safety of daratumumab will also be studied.~      This is an investigational study. Daratumumab is FDA approved and commercially available for~     treatment of multiple myeloma. It is considered investigational to use daratumumab to treat~     ALL.~      The study doctor can explain how the study drug is designed to work.~      Up to 72 participants will be enrolled in this study. All will take part at MD Anderson.~   "
27462|NCT03207529|"~     There are 2 parts to this study: Part 1 (dose escalation) and Part 2 (dose expansion).~      The goal of Part 1 of this clinical research study is to find the highest tolerable dose of~     alpelisib (also called BYL719) and enzalutamide that can be given to patients with breast~     cancer that is metastatic (has spread) and has come back after standard treatment or is~     intolerant to standard treatment.~      The goal of Part 2 of this study is to learn if the dose of alpelisib and enzalutamide found~     in Part 1 can help to control the disease.~      The safety of alpelisib when combined with enzalutamide will also be studied.~      This is an investigational study. Alpelisib is not FDA approved or commercially available. It~     is currently being used for research purposes only. Enzalutamide is FDA approved and~     commercially available for the treatment of metastatic, castrate-resistant prostate cancer.~     It is considered investigational to use alpelisib and enzalutamide to treat metastatic breast~     cancer.~      It is considered investigational to give alpelisib and enzalutamide together for breast~     cancer. The study doctor can explain how the study drugs are designed to work.~      Up to 28 participants will be enrolled in this study. All will take part at MD Anderson.~   "
27463|NCT03207516|"~     In a double-blind, randomised crossover study, two sourdough croissants (SC) or two brewer's~     yeast croissants (BC) were served to 17 (9 F; Age range 18-40; BMI range 18-24 kg/m2) healthy~     subjects to evaluate the effects of their ingestion on postprandial gastrointestinal~     functions. Hydrogen breath test was performed to measure H2 production after SC and BC~     ingestion. Gastric volume was evaluated by Magnetic Resonance(MR) Imaging to calculate~     gastric emptying rate in the 3-hour interval following croissant ingestion. Palatability and~     postprandial gastrointestinal symptoms and perceptions over a 4-h period after the meal were~     evaluated by visual analogue scale (VAS). In addition, in the 3-hour interval, blood samples~     were drawn to measure serum glucose levels. The area under the curve (AUC) was employed to~     evaluate global kinetics of all parameters and the T-test was used to evaluate differences~     between groups.~   "
27464|NCT03207503|"~     The aim of this study is to test a model of demographic (age, sex), clinical, cognitive, and~     neurocircuitry predictors of emotion regulation ability and long-term depressive symptoms.~   "
27465|NCT03207490|"~     The major issue for a person who has suffered a stroke is the severe impairment affecting the~     hand and the high risk to have a poor recovery associated. Innovative approaches are needed~     in the next future, translating recent advances from neuro-engineering, into feasible devices~     for rehabilitation care. The FP7-EU project MYOSENS aims to translate known motor control~     logic from sEMG prosthetic control, to rehabilitation robotics. The target is to promote the~     closing of sensory-motor loop on the basis of intention to move, as detected from residual~     sEMG (i.e. Extensor Digitorum Communis, Flexor Digitorum Profundus).~   "
27466|NCT03207477|"~     This study aim at following a cohort of prematurely born infants at 18 months corrected age,~     4 and 7 years of age. This cohort had an evaluation of visual maturation at term equivalent~     age (TEA) with factors associated with impaired visual maturation.~     (PREMAVISION-CLinicalTrials.gov ID: NCT02890251).~      In this follow-up study, prematurely born infants vision will be compared to term born~     infants matched for postnatal age.~   "
27467|NCT03207464|"~     This study aims to use [C-11]MRB PET (positron emission tomography) imaging to look at brain~     injury in patients with Multiple Sclerosis (MS) and healthy individuals. The overarching~     hypothesis is that there is decreased radioligand binding to the norepinephrine transporter~     in multiple sclerosis, reflecting injury to the noradrenergic system and that it plays a role~     in disease pathogenesis, its clinical manifestations and severity. This strategy is targeted~     to address an unmet need because currently available MRI techniques lack sensitivity and~     specificity for assessing such changes in the brains of people with MS.~      The specific aims of the study are:~        1. To determine norepinephrine transporter binding in the brains of MS patients using~          [C-11]MRB PET and compare it with age, and sex matched healthy controls.~        2. To determine correlation of norepinephrine transporter binding with clinical severity~          and MRI parameters in MS.~        3. To determine correlation of norepinephrine transporter binding with fatigue and~          cognitive impairment in MS patients.~   "
27468|NCT03207451|"~     This investigation will be conducted in patients 18-75 years of age with multiple coronary~     artery disease risk factors (antiplatelet naïve patients) and patients with prior MI or PVD~     on antiplatelet therapy. Pharmacodynamics will be assessed at multiple time points to assess~     onset-, maintenance-, and offset-effect of vorapaxar on thrombin generation, platelet~     reactivity, and plasma/platelet endothelial and inflammatory biomarkers. Safety assessment~     will be assessed throughout the study.~   "
27469|NCT03207438|"~     In essence the researchers are hoping to test two separate hypotheses (described below in the~     form of research questions). Therefore, the proposed analysis has been outlined according to~     each hypothesis.~      Hypothesis 1: Is low-dose quetiapine (50 mg/day) more effective for patients with depression~     who have insomnia at treatment baseline? (Stated differently: is low-dose quetiapine 50~     mg/day effective as monotherapy for patients with depression regardless of whether or not~     they have insomnia at baseline?).~      Hypothesis 2: Is high-dose quetiapine (150 - 300 mg/day) more effective for patients~     presenting with melancholic depression at treatment baseline?~   "
27473|NCT03207386|"~     The purpose of this matched comparison, multiple baseline study is to evaluate the~     effectiveness of a comprehensive youth-led sexual violence (SV) prevention program, Youth~     Voices in Prevention (Youth VIP). The prevention program builds on youth-adult partnerships~     among middle and high school students in Rapid City, South Dakota. Consenting students will~     take part in a youth summit where they will be trained as popular opinion leaders to spread~     SV prevention messages among middle and high school youth and parents. Following the summit,~     youth will work in small groups focused on different aspects of evidence-based prevention~     strategies including bystander intervention, social marketing messaging, parent education,~     norms change, and social emotional learning. Multiple research methods will be used to~     examine implementation process and cost. In addition, consenting students will take six~     surveys across three years including several surveys before programming begins, and several~     to document Youth VIP outcomes after prevention programming takes place. Survey data from a~     demographically similar community will be used to compare changes over time among youth in~     Rapid City, SD and youth a comparison city not implementing Youth VIP. All phases of the~     project will be implemented with collaboration from a Research Programming Advisory Board of~     community members and professionals from Rapid City, SD.~   "
27474|NCT03207373|"~     Patients with preexcitation are at risk for sudden cardiac death. The pathogenesis is a rapid~     antegrade conduction of atrial fibrillation over the accessory pathway to the ventricle~     resulting in ventricular fibrillation. Today it is possible to eliminate the conduction over~     the accessory pathway by catheter intervention (radiofrequency ablation) with a low rate of~     complications and a high rate of success. In clinical practice it is therefore important to~     estimate the risk for sudden cardiac death in an individual patient to give an advice to the~     patient and the parents about the further evaluation and therapeutic strategy. The velocity~     of the conduction over the accessory pathway can be estimated by analysing the ECG during~     sinus tachycardia. If the preexcitation disappears at a relatively low heart rate, the risk~     for sudden death is less than in patients with persisting preexcitation at the maximal heart~     rate. Compared to the gold standard i.e. measurement of the refractory period of the~     accessory pathway during invasive electrophysiological study (EPS), the measurements at the~     stress ECG have been reported to be a relatively poor indicator for an elevated risk which~     may be explained by a high intraindividual variability of this test. This study is designed~     to define the clinical relevance of the stress ECG in paediatric patients with preexcitation~     (compared to the invasive electrophysiological study).~      First Hypothesis:~      The results of the 3 stress ECG-tests are reproducible in an individual patient.~      Null hypothesis: there is no difference between the three measurements of cycle length during~     stress ECG. Alternate hypothesis: the difference between the three measurements of cycle~     length is > 10%.~      Second Hypothesis:~      There is a close correlation between the results at stress ECG and the results at the~     invasive electrophysiological Intervention.~   "
27475|NCT03207360|"~     The proposed study seeks to develop and test a novel psychosocial pain management~     intervention for patients with advanced cancer. It is hypothesized that the intervention will~     demonstrate feasibility, acceptability, and preliminary efficacy. The first aim is to develop~     a combined pain coping skills training and meaning-centered psychotherapy intervention. The~     second aim is to test the intervention's feasibility and acceptability as well as preliminary~     efficacy for improving primary outcomes (i.e., pain, pain interference, and meaning in life)~     and secondary outcomes. Two efficacious, theory-driven interventions will be integrated to~     address pain management by teaching pain coping skills with a novel emphasis on enhancing a~     sense of meaning in life. Participants will be patients with advanced cancer and~     moderate-to-severe pain. The study will be conducted in two phases. Phase I of the study will~     be intervention development. The intervention content will be guided by theory and mentoring~     from a team of leading experts in pain management and meaning-centered psychotherapy. Initial~     intervention content will be further informed by interviews with patients with advanced~     cancer. Content will then be refined through an iterative patient testing process. Phase II~     of the study will be a single-arm pilot trial testing the intervention. The intervention will~     be delivered in-person and consist of four, 45-to-60 minute therapy sessions. Study measures~     will be collected at baseline (0 weeks), immediately post-intervention (5 weeks), and 4-weeks~     post-intervention (9 weeks).~   "
27476|NCT03207347|"~     This open-label, non-randomized study will investigate the use of niraparib in patients with~     tumors known to have mutations in BAP1 and other select DNA damage response pathway genes.~   "
27477|NCT03207334|"~     This is an open label, single arm study of midostaurin in patients with relapsed or~     refractory AML.~   "
27478|NCT03207321|"~     This study will investigate the association between exposure to a daily nutritional~     supplement in utero and during the first three years of life and adult educational, marriage,~     and labor market outcomes in India. During 1987-1990, a controlled nutrition trial offered a~     daily cooked meal to pregnant women and children below the age of six years in 15~     intervention villages near the city of Hyderabad in South India. No supplementation was~     offered during the study in another 14 control villages. The trial and its follow up surveys~     are together known as the Andhra Pradesh Children and Parents Study (APCAPS).~      This protocol registration is for an analysis of the publicly available APCAPS third follow~     up wave (2010-2012) data. It is not a registration of the underlying 1987-1990 nutrition~     trial.~   "
27479|NCT03207308|"~     Despite economic growth in developing countries, Sub-Saharan Africa still faces food~     insecurity malnutrition and infections. Micronutrient deficiency and infectious diseases~     still remain a public health problem and have a negative impact on health and the economy.~     They are both directly and indirectly responsible for children morbidity and mortality. Due~     to high level of children mortality (139‰) Vitamin A Supplementation (VAS) program was~     implemented in Senegal since 1999. A national representative study undertook in 2010 to have~     biological data on vitamin status and infections, showed that 24.4% of children aged 1-5 y~     were Vitamin A Deficiency (VAD) and 50.2% were infected. To address VAD issue, large scale~     oil fortification was launched by government and private industries also fortified bouillon~     cubes. Furthermore, home fortification is being initiated without evaluation of VAD control~     strategies existing in the country.~      In order to assess the impact of national VAD control strategies in Senegalese children, this~     study was designed to measure in subsample of rural children aged 3-5 y, the current vitamin~     A total body stores in relation to their infectious status.~   "
27480|NCT03207295|"~     Nesiritide, a recombinant human B-type natriuretic peptide, has favorable effects on patient~     symptoms, hemodynamics, and the neurohumoral profile in adults with decompensated congestive~     heart failure and in those recovering from cardiac surgery involving cardiopulmonary bypass.~     Investigators seek to determine whether nesiritide would improve the early postoperative~     course after total cavo-pulmonary connection surgery in children.~   "
28481|NCT03194191|"~     Acupuncture is widely used for treatment of insomnia. The research hypothesis is that~     acupuncture may be more effective than sham acupuncture to treat insomnia during pregnancy.~      GAS is a randomized controlled trial with placebo acupuncture using the insomnia severity~     index (ISI) as the main outcome criterion.~   "
27482|NCT03207269|"~     Approximately 3 million Canadians have type 2 diabetes, a condition where the blood sugar~     levels are too high, uncontrolled blood sugars lead to cardiovascular disease and other~     complications. Patients with type 2 diabetes are often advised to consume a snack before bed~     in order to help control morning blood sugar levels. However, scientific evidence for this~     dietary approach is limited and there is no data to help elucidate what the ideal bedtime~     snack is. We hypothesize that a high protein, high fat snack with very little carbohydrate,~     will be an effective bedtime snack for lowering morning glucose without spiking glucose~     levels in the night. In this study we will determine if a bedtime snack that is high in~     protein and fat but low in carbohydrate can help improve morning glucose control in people~     with type 2 diabetes. This information will provide scientific evidence for the potential~     health benefits of strategically-timed high protein, high fat snack consumption in people~     with type 2 diabetes.~   "
27483|NCT03207256|"~     This is an open label compassionate use trial of Ublituximab and TGR-1202 in combination or~     as single agents in patients currently receiving treatment on Ublituximab and/or TGR-1202~     trials with B-cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia.~   "
27484|NCT03207243|"~     GSK3772847, an anti-interleukin (IL)33 receptor monoclonal antibody, is a novel treatment for~     asthma. This is a phase 2a study which aims to evaluate efficacy, safety, tolerability,~     pharmacokinetic (PK) and pharmacodynamic (PD) profiles of GSK3772847 in subjects with~     moderately severe asthma. The study will be conducted in 4 phases including screening, run-in~     phase, treatment phase and follow-up. In treatment phase, eligible subjects will be~     randomized to receive either GSK3772847 or placebo administered via intravenous (IV) route~     every 4 weeks in addition to open-label background therapy of fluticasone propionate/~     salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. During the treatment phase, the~     background therapy will be switched to FP 500 mcg for 2 weeks and the dose of FP will be~     reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. The~     total duration of study will be approximately 33 weeks and approximately 148 subjects with~     moderately severe asthma who are maintained on high-dose of inhaled corticosteroids/~     Long-Acting Beta-2-Agonists (ICS/LABA) will be randomized.~   "
27485|NCT03207230|"~     Study evaluates the relationships between daily physical activity levels (PAL) and functional~     capacity (VO2peak) in patients with dilated cardiomyopathy (DCM)~   "
27486|NCT03207217|"~     SIMmersion, in collaboration with the Institute for Family Health (IFH) and the Educational~     Development Center (EDC) propose to develop a web-based training product, Suicide Prevention~     Role-plays for Interactive Training (SPiRIT), a series of 4 modules to train providers to~     more effectively manage patients who screen positive for risk of suicide in this Phase~     I/Phase II fast-track application. If funded, the team will develop the Risk Assessment~     module in Phase I and utilize a within group pre-post design to evaluate its feasibility.~     Twenty practicing clinicians will be recruited to utilize the module and complete a pre-post~     knowledge test. In Phase II, the team will develop Safety Planning, Access to Lethal Means,~     and Willingness to Accept a Referral modules. The efficacy of the product to positively~     influence patient outcomes will be tested with a Historically Controlled Trial (HCT)~     enlisting 65 practicing clinicians across five IFH sites. All providers will be trained and~     patient outcomes will be tracked for 6 months post training. This data set will be compared~     to 6 months of historical data for the same provider group. Primary outcomes of this study~     will measure the participants' ability in obtain improved patient outcomes related to: 1)~     rate of same-day C-SSRS Screening; 2) rate of suicide being added to the problem list; 3)~     rate of same-day safety planning; 4) rate of same day C-SSRS Lifeline/Recent Completion; 5)~     rate of same-day Risk Assessment; 6) rate of acceptance and attendance to within-Institute~     referrals for post intervention patients who are offered the referral at the first visit; 7)~     and lower rates of documented suicide attempts. Ultimately, the development and successful~     testing of this product would provide the US health care system a novel technology to scale~     up a clinician's confidence and skill to better manage patients who identify as at-risk for~     suicide. Additionally, if effective, this product will have a direct impact on patient~     outcomes, a vital component to any training product that attempts to train health care~     professionals. The utility and scalability of the proposed product will move health care~     systems toward the goal of zero deaths from suicide consistent with the Zero suicide~     approach.~   "
27487|NCT03207204|"~     The objective of this clinical study is to evaluate the effect of the whitening treatment~     performed with the violet LED light (405-410 nm), with or without a bleaching gel, on the~     tooth color changes (immediate and long-term), tooth sensitivity, satisfaction of~     participants in relation to the technique and impact on their quality of life. After being~     informed of the objectives of the study, 200 participants will be selected and randomly~     divided into a treatment group (n = 25): G1 - 35% hydrogen peroxide (HP) (4 sessions, 1~     session/week); G2 - 30% carbamide peroxide (CP) (4 sessions, 1 session/week); G3 - Violet LED~     (405-410 nm, 4 sessions, 1 session/week); G4 - Violet LED (405-410 nm, 4 sessions, 2~     sessions/week); G5 - Violet LED associated to 35% hydrogen peroxide (4 sessions, 1 session /~     week); G6 - Violet LED associated to 30% carbamide peroxide (4 sessions, 1 session / week);~     G7 - hybrid technique HP (Violet LED + application of 35% hydrogen peroxide + violet LED) (4~     sessions, 1 session/week); G8 - Hybrid technique CP HP (Violet LED + application of 30%~     carbamide peroxide + violet LED) (4 sessions, 1 session/week). The color evaluation will be~     performed at predetermined times (before and immediately after treatment, 14 days after~     completion of bleaching and 3, 6 and 12 months after completion of bleaching), and~     quantitatively evaluated by colorimetric tests (objective and subjective) and~     spectrophotometry. In addition, it will be evaluated the tooth sensitivity during and after~     (48 hours) tooth whitening (VAS Scale), satisfaction with the treatment and impact on quality~     of life (OHIP-14 questionnaire). The data, except for survey data of satisfaction~     (descriptive evaluation), will be subjected to statistical analysis to determine the~     homogeneity and normality of the sample and for comparison between treatment groups,~     considering a 5% significance level.~   "
27488|NCT03207191|"~     Phase I, open label, single arm, non-randomized, multicenter, prospective dose escalation~     study in subjects with acute myeloid leukemia relapse after allogeneic hematopoietic stem~     cell transplantation (alloHSCT).~   "
27489|NCT03207178|"~     Cluster of differentiation antigen 19(CD19) specifically presents in B lymphocyte cell lines~     steadily,while not in most normal tissue,including pluripotent hematopoietic stem~     cells.Cluster of differentiation antigen 20(CD20) presents in 90% of B-cell lymphomas.CD19~     antigen is a well-established target for B-cell lymphomas treatment as well as CD20~     antigen.Both CD19-targeting CAR T Cells and CD20-targeting CAR T Cells can be used as~     adoptive cellular immunotherapies for B-cell lymphomas.Though two kinds of single target~     treatments were proved can induce recession of B-cell lymphomas, the risk of cancer cells to~     escape and tumor recurrence are still existed. There are no report about combination transfer~     of two kinds of single target treatments.This research aimed emphasis on safety and~     therapeutic efficacy evaluation,as well as if combination transfer can decrease recurrence~     rate.~   "
27500|NCT03207035|"~     We propose to compare the effects of local anaesthetic dilution on the characteristics of the~     ultrasound guided axillary brachial plexus block.~      Administration of 40ml lidocaine 1% with epinephrine will shorten the onset time of~     ultrasound guided axillary brachial plexus block when compared to 20 mL lidocaine 2% with~     epinephrine for elective upper limb surgical procedures.~   "
27501|NCT03207022|"~     Adjuncts to local anaesthetics for the peripheral nerve blocks such as epinephrine, clonidine~     and opioids have been widely used to enhance quality, duration of anaesthesia and~     postoperative analgesia. Clonidine, an α2-adrenergic agonist, when combined with local~     anaesthetics in axillary brachial plexus block has shown to decrease block onset time and~     prolong the duration of anaesthesia.~      We propose to compare the effects of combining both adjuvants to 20 mL of lidocaine 2% on the~     onset of ultrasound guided axillary brachial plexus block.~   "
27490|NCT03207165|"~     The investigators are interested in determining if there is a meaningful difference between~     two of the most commonly used medications used to improve the pumping function of the heart~     among critically ill patients admitted to the Coronary Care Unit (CCU) at the University of~     Ottawa Heart Institute (UOHI). To do this, the investigators will randomly assign patients~     who are felt to require use of these medications by their treating physicians to one of the~     two most commonly used agents in Canada: Milrinone or Dobutamine. Each patient will be~     closely monitored by their healthcare team, and their medication will be adjusted based on~     each patient's clinical status. Information from blood work (e.g. kidney and liver function,~     complete blood counts, and other markers of how effectively blood is circulating in the~     body), assessment of end-organ function (e.g. urine output, mentation), abnormal heart~     rhythms noted on monitoring and results of imaging studies (e.g. angiogram, echocardiograms.)~     will be collected for analysis. All patients will be followed for the duration of their~     hospital stay at UOHI.~   "
27491|NCT03207152|"~     This study aims to test the hypothesis that gene transcriptional changes occur within 24~     hours of virus exposure in the blood and nasal mucosa, and to identify early biomarker~     signatures that are predictive of higher viral shedding at the peak of disease~   "
27492|NCT03207139|"~     This is an open-label single arm clinical trial, plan to enroll approximately a total of 62~     evaluable subjects. According to the estimated missing rate 15%, the sample size in this~     study is 73.~      Inclusion criteria:~      To be eligible for inclusion, each patient must fulfill all of the following criteria:~        1. Age equals or more than 20 years old~        2. Willing to sign the informed consent~        3. Pathology-proved intermediate to high risk group prostate cancer patients (PSA > 10~          ng/mL, or Gleason score 7-10, or clinical stage >T2a) OR Prior radiotherapy or~          prostatectomy for prostate cancer with biochemical recurrence defined as:~             -  post prostatectomy: increase in PSA of > 0.2 ng/mL in two or more consecutive blood~               samples~             -  post radiotherapy: PSA levels of ≥ 2 ng/mL above the post-therapy nadir~        4. Life expectancy more than 3 months~      Exclusion criteria:~      Patient who has any of the following criteria will be excluded from the trial:~        1. Unable to tolerate the PET/CT scan, such as those with claustrophobia, unable to lie~          still, consciousness unclear, vital sign unstable.~        2. With renal impairment (glomerular filtration rate lower than 30 ml/min/1.73 m2), and~          allergy to medium contrast~        3. Unable to give informed consent.~        4. Allergy history to Ga68-PSMA ligand, significant abnormal lab data (ALT more than three~          times of normal value), and high risk to conduct examination after evaluations of PI.~        5. Patient had malignancy history~   "
27493|NCT03207126|"~     Aim: Assess accuracy of histological diagnosis using ultrasound guided biopsy for women with~     suspected endometrial cancer (as an alternative to hysteroscopy guided biopsy).~      All women presenting to clinic with suspected endometrial cancer will have an internal~     ultrasound. If the endometrial lining is thickened an endometrial biopsy will be performed.~     This can sometimes be done in an outpatient clinic, or sometimes a hysteroscopy and biopsy is~     needed (on a different day). Hysteroscopy guided biopsy has the advantage of enabling the~     clinician to perform directed biopsies under vision.~      Ultrasound guided biopsy is a ubiquitous procedure when used elsewhere in the body however it~     is not routinely used in this context. It does have the advantage of being easily performed~     on the same day as the first consultation. In this pilot study we will assess the diagnostic~     ability and tolerability of ultrasound guided biopsy of women with suspected cancer, as an~     alternative to hysteroscopy guided biopsy.~   "
27494|NCT03207113|"~     The Ned case study is a 12-month mixed methods embedded single-case study with a nested~     within-group pre-post comparison of health outcomes. 400 patients, 200 caregivers, and 10~     clinicians will be given access to Ned. Participants will be asked to complete study~     assessments at baseline, 2 months, 6 months and 12 months. 30 semi-structured qualitative~     interviews with patients (n=20) and their caregivers (n=10) post-study will also be conducted~     to gain insight into their experience with the application.~   "
27495|NCT03207100|"~     This study evaluates safety and efficacy of analgesia-first minimal sedation as an early~     antihypertensive treatment for spontaneous intracerebral hemorrhage. The analgesia-first~     minimal sedation strategy relies on the remifentanil-mediated alleviation of pain-induced~     stress response and the antisympathetic activity of dexmedetomidine to restore the elevated~     blood pressure to normal level in patients with spontaneous intracerebral hemorrhage. This~     strategy allows rapid stabilization of blood pressure, and its use as a pre-treatment for~     patients on mechanical ventilation prior to painful procedures reduces blood pressure~     variability and thereby results in etiologic treatment. It is more effective in blood~     pressure control than conventional symptomatic antihypertensive treatment, reduces the~     incidence of early hematoma expansion and improves prognosis, ,lowers healthcare workers~     workload, increases patient adherence, and improves healthcare worker satisfaction.~   "
27496|NCT03207087|"~     This trial is a prospective, multicenter, single-arm Objective Performance Criteria~     controlled confirmatory study. It is for evaluating safety and effectiveness of the WEB~     Aneurysm Embolization System when treating wide neck bifurcation aneurysms (WNBN).The study's~     primary endpoints include a primary effectiveness endpoint and a primary safety endpoint. The~     study device must meet both endpoints. The primary effectiveness endpoint is adjudicated by~     an independent third party core lab.~   "
27497|NCT03207074|"~     Aim: Determine if Rapid Evaporative Ionization Mass Spectrometry (the iKnife); can diagnose~     cancer and pre-cancer from endometrial tissue biopsy samples.~      Women attending a gynaecology clinic for assessment of abnormal bleeding will receive an~     pelvic (internal) ultrasound as routine standard of care. If any abnormalities are detected,~     a tissue sample will be needed. If women are agreeable a second tissue sample will be taken~     for research. The first will be analysed by conventional means (histopathology). The second~     sample with new technology called the 'iKnife'. This is a modified type of Mass spectrometry~     device, that separates particles based on their mass charge ratio. The idea being that if~     tissue is burnt, gas is produced, and this gas contains lots of ions that can be analysed by~     the iKnife. Each type of tissue (cancer or non-cancer) will have a unique signature that the~     iKnife can use to distinguish between samples. If effective it could be used in future~     outpatient clinics to provide a one-stop, true point of care diagnosis.~   "
28496|NCT03193996|"~     The study seeks to determine whether the 4DCT imaging technique can be used to replace~     current invasive diagnostic tests for ligament injuries of the wrist.~   "
27502|NCT03207009|"~     This is a single-arm, multi-site, single-dose, Phase 3 study in approximately 15 subjects ≤50~     years of age with transfusion-dependent β-thalassemia (TDT), who have a β0 mutation at both~     alleles of the β-globin (HBB) gene (i.e. β0/β0). The study will evaluate the efficacy and~     safety of autologous hematopoietic stem cell transplantation (HSCT) using LentiGlobin BB305~     Drug Product.~   "
27503|NCT03206996|"~     Auditory hyper-reactivity affects up to 66% of children with autism spectrum disorder (ASD)~     and has been linked to greater stress and anxiety for children and their families. Exposure~     and Response Prevention (E/RP) is highly effective for reducing obsessive/compulsive~     behaviors in children with both OCD and ASD. This study is the first to assess the~     feasibility and efficacy of E/RP for auditory sensory hyper-reactivity in ASD.~   "
27504|NCT03206983|"~     To evaluate the intraoperative stability, safety and overall efficacy of the Canabrava Ring~     (AJL - SPAIN) when used to expand pupils with less diameter than 5 mm and pupils with~     sphincter synechiae.~   "
27505|NCT03206970|"~     This is a single-arm, open-label, multi-center Phase 2 study in subjects with histologically~     documented MCL who have no response or relapse after ≥ 1 but < 5 prior treatment regimen(s).~     The study is composed of an initial screening phase, a single-arm treatment phase, and a~     follow-up phase.~   "
27506|NCT03206957|"~     In approximately half of individuals with Down syndrome, an higher than normal number of~     vessels cross the optic disc margin. Investigator hypothesize that early retinal vessel~     branching occurs due to inhibition of angiogenesis by triplet overexpression of endostatin,~     an angiogenesis inhibitor encoded on chromosome 21. Since angiogenesis is critical in the~     development of eyes and other organs angiogenesis depended (specially kidney, brain, and~     recently described lungs and heart), early branching of retinal vessels at the level of the~     optic disc would also likely result in abnormal renal and other organs development in these~     individuals. Investigator wish to determine whether observation of optic disc vessels may~     serve as an indicator of elevated endostatin levels and other angiogenesis-dependent organs~     anomalies.~   "
27507|NCT03206944|"~     The reducing the anti-aggregation properties of platelets significantly decreases the risk of~     myocardial infarction and the total number of cardiovascular events. In patients who have~     cardiovascular disease, anti-platelet therapy reduces the risk of serious vascular events.~     Side effects, such as bleeding, are relatively small so the benefits of anti-platelet therapy~     in secondary prevention exceed the risk of these side effects. According to guidelines for~     the treatment of arterial hypertension, PTNT 2015, patients with arterial hypertension (HA)~     that have a 20% or higher risk for cardiovascular events in the next 10 years, should have~     ASA included in their treatment to reduce this risk. It has been proved that the use of~     acetylsalicylic acid in secondary prevention reduces the risk of major cardiovascular events,~     while the benefits of ASA in primary prevention have recently been debated. The benefits of~     using ASA in primary prevention should always be confronted with the risk of hemorrhagic~     complications of this therapy According to 2016 European Guidelines on cardiovascular disease~     (CVD) prevention in clinical practice, anti-platelet therapy is not recommended in~     individuals who do not suffer from CVD, due to the increased risk of major bleeding. It is~     important to look for alternative anti-platelet therapy for people with cardiovascular risk~     factors. Standardized tomato extract (STE) does not cause side effects and may have multiple~     beneficial effects on total cardiovascular risk, primarily by inhibiting platelet~     aggregation. Since its discovery in 1999, several studies and human trials with STE have been~     carried out. During the last 50 years, tomato (Lycopersicon esculentum) has become a highly~     consumed food. The benefits of inhibiting platelet activity through diet are currently~     difficult to determine due to the lack of clear and comprehensive scientific data. It is~     difficult to specify the over activity of the plaques or their proper activity. However,~     there are data available that indicate the benefits of a diet containing diminishing activity~     of platelets (Mediterranean diet) and lowering cardiovascular risk.The investigators want to~     conduct a comparison of the less common STE with clinically recognized ASA. The aim of the~     study was to compare the anti-platelet effect of STE and ASA in hypertensive patients with~     high cardiovascular risk.The study highlights that STE may be an alternative, food-based~     strategy to control the platelets reactivity.~   "
27508|NCT03206931|"~     LOXO-195 expanded access is for patients with cancer with a NTRK1, NTRK2, or NTRK3 gene~     fusion who are ineligible for an ongoing LOXO-195 clinical trial or have other considerations~     that prevent access to LOXO-195 through an existing clinical trial. Expanded access is~     intended to treat individual patients with different types of cancers, including blood~     cancers, with a NTRK gene fusion who have previously received TRK inhibitor therapy~   "
27509|NCT03206918|"~     This is a single-arm, open-label, multi-center Phase 2 study in subjects with histologically~     documented CLL/SLL who have relapsed after ≥ 1 prior treatment regimen(s). The study is~     composed of an initial screening phase, a single-arm treatment phase, and a follow-up phase.~   "
27510|NCT03206905|"~     The purpose of this study is to compare the effect of endoscopic sleeve gastroplasty (ESG)~     with diet and exercise, to diet and exercise alone, to see which is better in weight loss~     reduction. We will also compare the effects of ESG to diet and exercise comorbidities such as~     diabetes, sleep apnea and high cholesterol as well as the various obesity related hormones.~   "
27511|NCT03206892|"~     laparoendoscopic single-site surgery is compared to conventional multi-port laparoscopy for~     polycystic ovary syndrome in infertile women undergoing ovarian drilling as regards~     successful surgical procedure with less side effects~   "
27512|NCT03206879|"~     Norwegian hospitals are struggling to control spread of extended-spectrum beta-lactamase~     producing Enterobacteriaceae (ESBL-E) in health care settings. Strict screening and isolation~     criteria are enforced in hospital, and patients previously infected by ESBL-E are regarded as~     possible ESBL-E carriers indefinitely. This observational multi-centre cross-sectional study~     aims to estimate the duration of fecal ESBL-E carriage and to assess the risk of ESBL-E~     resurgence during hospital stay for patients previously infected by ESBL-E. Through better~     knowledge of these risk factors, infection control procedures may be better tailored to rhe~     individual patient.~   "
27513|NCT03206866|"~     Although the diagnosis and therapy of HCC have being improved, the poor prognosis still~     remains. To reduce the mortality and improve the effectiveness of diagnosis and therapy, it~     is important to detect the protein biomarkers which are associated with HCC tumor progression~     and may be useful as potential diagnosis or therapeutic targets.~      SMP30 (senescence marker protein 30)(serum regucalcin), which we have previously identiﬁed~     from Guangxi HCC cDNA expression library by the SEREX approach, is one of the hepatocellular~     carcinoma associated antigens [4]~      Serum antibody response to SMP30 in various patients using the methods of Western-blot and~     ELISA and showed that antibody to SMP30 existed mainly in HCC patients (39.8%), especially in~     the one with alpha-fetoprotein (AFP) negative~   "
27514|NCT03206853|"~     To evaluate the clinical benefits and risks of hybrid operating techniques in management of~     complex intracranial aneurysms, which could coexists with multiple risk factors.~   "
28508|NCT03193840|"~     Posterior wall osteotomy would be conducted to manage the old acetabular fracture. The~     outcome was reviewed to assess the feasibility of the surgical procedure.~   "
27515|NCT03206840|"~     Despite the increasing popularity of mindfulness meditation and hypnosis in healthcare and in~     the general community the underlying neurobiological mechanisms are unclear. The change in~     the relationship between the self and the conscious experience that they bring about may be~     crucial. This study aims to identify the neural correlates of self-consciousness in~     meta-awareness and absorption - using functional Magnetic Resonance Imaging (fMRI) in healthy~     participants combined with detailed first-person experiential accounts and behavioural tasks.~     This study will provide important clues about the widely reported effects of mindfulness~     meditation and hypnosis and shed light on the neural correlates of the conscious experience~     of self.~   "
27516|NCT03206827|"~     The aim of this study is to investigate the effects of dietary plant and animal proteins on~     gut metabolism and markers for colorectal cancer as well as blood protein metabolites and~     markers for type 2 diabetes in healthy adults. The study participants will be stratified into~     three groups with different protein composition in diets: 1) animal 70%/plant 30%; 2) animal~     50%/plant 50% and 3) animal 30%/plant 70%. The participants will get part of their diet as~     ready foods or raw material to promote their compliance. The participants will also get~     personal advice for their diets. Blood, stool and urine samples will be collected in the~     beginning and in the end of the 12 week intervention, as well as phenotype measures like BMI,~     blood pressure and body composition. The participants will also fill food diary before and in~     the end of the intervention.~   "
27517|NCT03206814|"~     The CHARGE-APP project will investigate whether an innovative management strategy of~     hypertension based on the combination of usual care visits and ESH CARE App compared to~     standard care, is associated with differences in outcome, including control rate of office,~     home and ambulatory BP, cardiovascular and renal intermediate end points at one year, and~     changes in a number of blood pressure-related variables throughout the study.~   "
27518|NCT03206801|"~     This is a Phase II-III multi-center prospective randomized controlled clinical trial of~     incident adult renal transplant patients.~      The primary objective of this study is to determine if the early treatment of rejection, as~     detected by urinary CXCL10, will improve renal allograft outcomes.~   "
27519|NCT03206788|"~     The purpose of the study is to examine if a specific drug called losartan (Cozaar ®),~     generally used to treat high blood pressure and to protect kidneys from damage in patients~     suffering from Diabetes Mellitus, will have any effect on the nasal inflammation in patients~     with cystic fibrosis (CF). The study will be performed at the Pulmonary Division at the~     University of Miami, Cincinnati Children's and University of Alabama-Birmingham~   "
27520|NCT03206775|"~     Phase 1: This is a remote observational study in which participants will complete cognitive~     assessments developed by Posit Science. Participants will be healthy controls aged 18-65 with~     reliable internet access and a device that they can use to access the assessments, such as a~     laptop or iPad. Participants will complete up to 6 Posit Science assessments in different~     domains of cognition, which should last approximately 30 minutes.~      Phase 2: This is an in person observational study in which participants will complete~     cognitive assessments developed by Posit Science. Participants will be healthy controls aged~     18-80 who are fluent in English, . Participants will complete one of three batteries~     developed by Posit Science, which include combinations of visual, auditory, and social~     cognitive assessments. Afterwards participants will complete TEPS and BIS/BAS surveys. This~     study will be conducted at the Driven to Discover building at the Minnesota State Fair.~     Participation will last approximately 20 minutes.~   "
27521|NCT03206762|"~     A prospective, multicenter, randomized study evaluating the use of Jetstream Atherectomy (JS)~     followed by DCB in comparison to the use of plain old balloon angioplasty (POBA) followed by~     DCB alone in the treatment of complex lesions in femoropopliteal arteries in subjects with~     claudication (Rutherford Clinical Category (RCC) of 2-4) (complex lesions are defined as long~     (≥ 10 cm) lesions, or moderately or highly calcified lesions, or chronic total occlusions~     irrespective of length).~   "
27522|NCT03206749|"~     This is a Phase 2 randomized, double-blind, placebo-controlled, 3-arm, parallel design study~     to evaluate the efficacy and safety of VX-150 in treating acute pain following bunionectomy.~   "
27523|NCT03206736|"~     The biliopancreatic diversion and duodenal switch (BPD-DS) is an accepted and published type~     of bariatric surgery in the United States. The surgery involves both restriction and~     malabsorption to achieve weight loss by creating a sleeve gastrectomy as well as two~     intestinal connections that bypass some of the small intestine, decreasing the amount of food~     that is absorbed. The BPD-DS procedure produces the most weight loss of any bariatric surgery~     commonly performed but has the highest risk of malnutrition and gastrointestinal side~     effects. The loop duodenal switch (L-DS) is a bariatric surgery which has been modified from~     a biliopancreatic diversion and duodenal switch to maintain excellent weight loss while~     possibly reducing side effects. The surgical modifications in this procedure include reducing~     the number of intestinal reconnections from two to one and reducing the amount of small~     intestine which is bypassed. The L-DS operation is considered experimental by the American~     Society of Metabolic and Bariatric Surgery as long-term data in large numbers of patients is~     not available for weight loss or side effects. The purpose of this study is to examine weight~     loss and other outcomes in the L-DS operation up to 1 year after the procedure.~      Patient eligibility criteria: between 19-70 years of age at enrollment, BMI ≥ 40 kg/m2, and~     the subject is under consideration for surgery for obesity or metabolic disease and elects to~     undergo a primary loop duodenal switch procedure or as a conversion procedure for failed,~     sustained weight loss after a sleeve gastrectomy or laparoscopic adjustable gastric band~     performed more than 12 months prior to time of evaluation. All subjects will undergo a~     standard comprehensive bariatric surgery evaluation which includes but is not limited to~     nutrition consultation, psychological evaluation, laboratory tests and supervised medical~     weight loss. Once the study subjects have met all of the insurance requirements, the~     bariatric clinic will submit for insurance approval for a duodenal switch operation. Once~     surgery is approved, study subjects will have a standard pre-operative history and physical~     visit no more than 30 days prior to surgery and will fill out a survey regarding~     health-related quality of life and amount of gastrointestinal symptoms experienced (diarrhea,~     constipation, bloating, etc).~      This study does not change the number of visits, timing of visits, or laboratory blood draws~     surgical patients would have with the bariatric surgery clinic or staff. Study subjects will~     be seen in the clinic at 2 and 6 weeks, and 3, 6, 9, and 12 months per the bariatric surgery~     center protocol. As part of these normally scheduled visits, weight loss and health status~     will be recorded. Labs will be checked at 3, 6, and 12 months for nutritional status. A~     survey to reassess health-related quality of life and gastrointestinal symptoms will be~     performed at 3 months, 6 months and 12 months.~   "
27524|NCT03206723|"~     Two percent of all patients presenting to the Emergency Departments have complaints involving~     the eye. Corneal abrasions are a common diagnosis with patients with eye pain and often cause~     significant discomfort. Current treatment includes a thorough evaluation of the eye followed~     by patching, empiric antibiotics, cycloplegics and oral pain medicines. This study will be a~     randomized controlled trial to determine the safety and efficacy of BCLs. It will involve the~     initial patient evaluation followed by a return visit to the Emergency Department within 36~     hours for re-examination. At each visit, the patient will be assessed for the size and~     location of the abrasion along with their report of pain using a visual analog scale. Data~     will be recorded on a standard data collection sheet. Telephone contact will be made at 30~     days to ensure resolution of abrasion and that no complications ensued.~   "
27525|NCT03206710|"~     In a randomized clinical trial (RCT) published in JAMA, the investigators have provided~     evidence that vitamin C supplementation (500 mg daily during pregnancy) ameliorates the~     effects of maternal smoking during pregnancy on offspring lung function and subsequent~     incidence of wheeze by 48% through 1 year of age. The investigators are currently completing~     a second RCT of vitamin C supplementation in pregnant smokers with more robust measures of~     pulmonary outcomes. The purpose of this ECHO application is to combine these 2 focused,~     interventional cohorts to allow critical longitudinal follow-up of respiratory outcomes in~     these children including the study of pulmonary function test (PFT) trajectories and~     incidence of recurrent wheeze/asthma from infancy through early adolescence in offspring of~     pregnant smokers randomized to vitamin C versus placebo.~   "
27526|NCT03206697|"~     The present study has the objective to study whether the mitochondrial DNA copy number values~     that can be generated when human embryos are analyzed for chromosomal content before embryo~     transfer correlates with the actual number of mitochondria as well as their energy~     requirements of the human embryo.~   "
27527|NCT03206684|"~     A Prospective, open, randomized, controlled clinical study to evaluate the efficacy and~     safety of PEG-rhG-CSF(PEGylated recombinant human granulocyte stimulating factor injection)~     in reducing neutropenia during TP(docetaxel+cisplatin) regiment simultaneous~     radiochemotherapy and adjuvant chemotherapy in patients with cervical cancer~   "
27528|NCT03206671|"~     The trial B-NHL 2013 is a collaborative prospective, multi-national, multi-center, randomized~     trial with participating centers of the NHL-BFM group (Austria, Switzerland, Czech Republic,~     Germany) and the Scandinavian NOPHO group (Denmark, Finland, Norway, Sweden). The aim of the~     trial is to evaluate the role of rituximab in the treatment of mature aggressive B-cell~     Non-Hodgkin lymphoma and leukemia (B-NHL and B-AL) in children and adolescents.~      The following primary study questions are going to be analyzed:~        -  the effectiveness (event-free survival) in pediatric patients with very limited mature~          B-NHL (R1 and R2 stage I and II) of substituting anthracyclines by the rituximab window~          without compromising survival rates.~        -  the effectiveness (event-free survival) in pediatric patients with limited mature B-NHL~          (R2 stage III) randomly assigned to receive the rituximab window plus standard~          chemotherapy or standard chemotherapy without the rituximab window.~        -  the effectiveness (event-free survival) and the immune reconstitution (recovery of CD19+~          B-cells, IR) in pediatric patients with advanced mature B-NHL/B-AL (R3 and R4 incl. R4~          CNS+) treated with BFM-type chemotherapy and randomly assigned schedules of one versus~          seven doses rituximab.~      Secondary study questions will address~        -  additional parameters for immune reconstitution, lymphocyte subpopulations,~          immunoglobulin levels, vaccination titers and infection rates~        -  kinetics of immune reconstitution after treatment~        -  adverse event and severe adverse event profile~        -  inter-individual variability of rituximab response~        -  role of different mechanisms of action of rituximab in advanced B-NHL/B-AL~   "
27529|NCT03206658|"~     This study was designed to evaluate the effect of spironolactone administration in the~     incidence and severity of AKI in patients critically ill with invasive mechanical ventilation~     (IMV) in the critical care unit.~      Patients in critical care unit (CCU) are the most at risk of developing AKI. In most cases a~     mechanism of ischemia/reperfusion has a central role in the development of AKI. Aldosterone~     has traditionally been recognized as a mediator that maintains water and sodium homeostasis.~     Nevertheless, there are enough evidence in humans and experimental models that aldosterone~     might mediate detrimental effects on renal function and structure in pathophysiological~     conditions. Indeed, several experimental studies from our laboratory have shown that~     mineralocorticoid receptor blockade protects the kidney against ischemia/reperfusion injury.~      The aim of this study is to know:~      o If mineralocorticoid receptor blockade may reduce the incidence and severity of AKI in~     critically patients with IMV in CCU.~      You may be able to enter in this study if:~        -  You are at least 18 years old.~        -  You are male or female~        -  You are with IMV.~        -  You are in CCU.~        -  Your serum K is less than 4.5 mEq/L~        -  Your BP is >90/70 mmHg~      You cannot enter this study if:~        -  You have CKD~        -  You have AKI~      This study will recruit 90 patients from Instituto Nacional de Ciencias Médicas Salvador~     Zubiran in México City. The study will begin in April 2017. The patients will be randomized~     to one of 2 groups of treatment (Spironolactone 25 mg or placebo). All treatments looks~     identical (1 capsule), will be administered through the nasogastric tube. Neither the~     patients nor their doctors will be able to know or decide which group you are in. You will~     receive the medication during the first five days of stay in the critical care unit.~      As part of this trial, the doctors will ask your permission to get a sample urine during this~     days. They will use the samples to do tests in the laboratory (different to routine tests)~     that may help them to compare renal function and biomarkers of renal injury. Your~     participation will end 10 days after your entry into the critical care unit. The most common~     side effect of spironolactone is hyperkalemia.~   "
27530|NCT03206645|"~     This is an open-label Phase Ib dose-escalation study to assess MTD, safety, tolerability, and~     PK of PTC596 when combined with standard paclitaxel and carboplatin for women with stage III~     or IV epithelial ovarian, primary peritoneal or fallopian tube cancer receiving neoadjuvant~     chemotherapy. For all cohorts, PTC596 will be given in combination with paclitaxel and~     carboplatin.~   "
27531|NCT03206632|"~     The primary objective of this trial is to investigate the safety and tolerability of BI~     690517 in healthy Chinese and Japanese male subjects following oral administration of single~     doses.~      Secondary objectives are the exploration of the pharmacokinetics (PK) including dose~     proportionality as well as the investigation of pharmacodynamic effects following single~     rising doses of BI 690517.~   "
27532|NCT03206619|"~     Patients attending the smoking cessation programme at the Virgen del Rocío University~     Hospital under the SoLoMo clinical trial of the SmokeFreeBrain project and provided with the~     SoLoMo mobile app will be observed for one year. This mobile app which sends the patients~     tailored health motivational messages selected by a health recommender system, and based on~     their user profile retrieved from an electronic health record. Patients' messages feedback~     and interactions with the app will be analyzed and evaluated following an observational~     prospective methodology to see whether patients like the messages, and measure the patient~     engagement with the health recommender system.~   "
27551|NCT03206359|"~     GADD34 (Growth Arrest and DNA Damage inducible-protein) is a regulatory subunit of PP1~     (phosphatase 1) phosphatase which dephosphorylates eIF2alpha (eucaryotic initiation factor 2~     alpha subunit), representing a negative feedback loop of the unfolded protein response (UPR).~     Moreover, GADD34 is necessary for type I interferon (IFN) production in response to viral~     infection in murine models. We investigate here the expression of GADD34 in systemic lupus~     erythematosus (SLE), in which type I IFN has an important pathogenic role.~      We report a case-control study on GADD34 gene expression in PBMC (peripheral blood~     mononuclear cells) of SLE patients (n=60) and age- and sex-matched healthy controls (n=30).~     The level of GADD34 gene expression, as well as of type-I IFN response genes in PBMC is~     measured by quantitative PCR.~   "
27533|NCT03206606|"~     Problematic: Spirometry is used to objectify the obstructive syndrome defining chronic~     obstructive pulmonary disease (COPD). However, this test remains underused in the primary~     care. The tools available for its interpretation are little used and the existence of several~     decision algorithms can create confusion during the diagnosis.~      Principal objective: To evaluate the impact of a mobile application (SPIRO©) on medical~     practice (interpretation and prescription of spirometry) of family physicians and family~     medicine residents working in family medicine units (FMU) in Quebec affiliated with Laval~     University.~      Secondary objective : To evaluate the usability of SPIRO© among family physicians and~     residents in family medicine working in FMU in Quebec affiliated with Laval University.~      Methods: This is a pre-post clinical trial with control group. Participants (family MD and~     family medicine residents) will be recruited from the various FMU affiliated with Laval~     University. Participants working in the FMU in the experimental group will be able to use the~     SPIRO® mobile application to facilitate interpretation of the spirometry test results while~     participants in the control group will not have access to it during the study. The basic~     characteristics of the participants and various behavioral parameters based on the theory of~     planned behavior concerning the interpretation and prescription of spirometry test will be~     measured. Data from the control group will be collected before those in the experimental~     group at the time the application is not yet available, which will minimize contamination~     between groups. The data will be collected with questionnaires delivered in person to the~     participants before the intervention (T0 time) and then four months later (T1 time) during~     their team or research meeting. Participants will be recruited in eight of the 12 Quebec FMU~     affiliated with Laval University, who will be randomly assigned to two equal groups: control~     and experimental. The intervention will consist in sending the SPIRO© mobile application to~     participants in the experimental group who will use it for a period of four months.~   "
27534|NCT03206593|"~     Current prospective cohort study is to evaluate the association between fasting lipid~     profiles (including total cholesterol, low density lipoprotein-cholesterol, high density~     lipoprotein-cholesterol, triglycerides, apolipoprotein A, apolipoprotein B and~     lipoprotein(a)) and fasting plasma glucose at admission with cardiovascular disease outcomes~     (including fatal and non-fatal myocardial infarction, fatal and non-fatal ischemic stroke,~     re-hospitalization due to heart failure, revascularization by percutaneous coronary~     intervention or coronary artery bypass grafting, or cardiovascular mortality) and all-cause~     mortality.in patients with ischemic heart failure and left ventricular ejection fraction < 45~     % evaluated by echocardiography during 12 months follow-up.~   "
27535|NCT03206580|"~     Life expectancy and elderly population are increasing. Health professionals try to provide~     longevity with good quality of life for this population, through the functional independence~     maintenance. In this context, physical exercise has an important role, specially the strength~     training. The ability to produce muscle strength is positively associated with the~     functionality and independence of older people. Different types of strength training can lead~     to different neuromuscular and functional gains. These types of interventions can help health~     professionals to determine characteristics of training for the elderly, aiming the~     maintenance of their functional independence. Thus, the purpose of this study is to determine~     the effects of a concentric strength training versus a concentric-eccentric strength training~     for knee flexors and extensors on structural, neuromuscular and functional parameters in~     older people, as well as to investigate the effect of a detraining period. Additionally, the~     investigators will try to identify which structural and neuromuscular parameters of lower~     limbs are better related to the functionality.~   "
27536|NCT03206567|"~     NUTRAFOL® is a novel nutraceutical supplement, scientifically formulated to specifically~     target the multiple underlying causes of hair loss and thinning in women. It does not contain~     hormones, drugs, or industry by-products.~      The purpose of this clinical research study is to evaluate the safety, efficacy and~     physiological effects of NUTRAFOL® supplement compared to placebo in forty (40) female~     subjects, ages 21-65 years of age with self-perceived thinning hair over the course of six~     months of continued use.~   "
27537|NCT03206554|"~     40 patients ASA I-III, undergoing total knee arthroplasty were randomly assigned, into one of~     two groups, namely group LIA (n=20), where local infiltration analgesia would be administered~     intraoperatively; and group sham LIA (n=20), where sham injections of normal saline would be~     administered. All patients received a standardized multimodal approach, including pregabalin,~     adductor canal peripheral nervous blockade, spinal anaesthesia, paracetamol, and PCA with~     morphine. Morphine consumption during the first 24 hours postoperatively was measured and~     additionally the investigators recorded: Time of morphine first dose administration, NRS~     scores in static and dynamic conditions in 6 hours, 12 hours, 18 hours and 24 hours~     postoperatively, complications, patient satisfaction and duration of hospitalization.~   "
27538|NCT03206541|"~     This is a multi-center case-control study that aims to define the association between the~     exposure to an arbovirus infection and the development of a neurological syndrome in patients~     from Colombia. The study makes part of the Neurovirus Emerging in the Americas Study (NEAS)~     that is a collaborative effort that looks to combine the efforts of researchers, healthcare~     providers and patients in Colombia to establish a comprehensive registry of the clinical,~     radiological and laboratory profile of patients with new onset of neurological diseases~     associated mosquito-borne viruses, known as arboviruses.~   "
27539|NCT03206528|"~     This is an observational, cohort-based, single-site, prospective study conducted in~     accordance with ISO 14155-1:2003 and ISO 14155-1:2011. The primary objectives are to evaluate~     the accuracy of the device's measurements/readings in comparison to a gold standard or~     standard of care patient monitor.~   "
27540|NCT03206515|"~     Percutaneous nephrolithotomy (PNL) has been considered as the first-line choice for the~     management of >20mm kidney stones. Microchannel percutaneous nephrolithotomy (Mini PCNL)~     which takes nephrolithotomy channel size less than or equal to 18, was first used in the~     treatment of children with kidney stones in 1997, then gradually applied to adult, aims to~     achieve the similar stone clearance rate as the standard channels, at the same time, reduce~     the complications. At present, the use of percutaneous renal surgery in our country is more~     than 18F plastic peel-away sheath, with the access sheath with a suction-evacuation function~     was first used by Guohua Zeng and so on. But there is still a lack of high quality evidence~     of Evidence-based medical evidence to compare the two kinds of sheath for the safety and~     effectiveness. Therefore, this study provides a reliable theoretical basis for the choice of~     the sheath for the treatment of 2-5cm size Kidney, and ultimately benefit patients with 20mm.~   "
27541|NCT03206489|"~     The investigators compared advantages and disadvantages of two forms of noninvasive~     respiratory support —noninvasive high-frequency oscillatory ventilation (nHFOV) or nasal~     continuous positive airway pressure (nCPAP) —as a primary mode of ventilation in preterm~     twins infants with respiratory distress syndrome~   "
27552|NCT03206346|"~     The purpose of this study is to determine whether Ingavirin ® dosed 60 mg daily is effective~     and safe in the treatment of influenza and other acute respiratory viral infections in 13-17~     years old patients.~   "
27542|NCT03206476|"~     The objective of the study was to demonstrate the efficacy of a nutritional intervention~     based on the Social Cognitive Theory and the Transtheoric Model in the favorable modification~     of eating habits in adolescents of secondary education.~      The hypothesis was that secondary school adolescents receiving a nutritional intervention~     based on Social Cognitive Theory and the Transtheoric Model presented more favorable~     modifications in their eating habits than adolescents who only received nutritional~     information.~      A community trial was conducted with pilot testing for the validation of the study~     instruments. Adolescents from the second grade of the afternoon shift of the Jalisco~     Technical High School Nº46 participated in the 2015-2016 cycle.~      Self-completed questionnaires evaluated socioeconomic variables, physical activity habits,~     stage of change (Transtheoric Model), constructs of the Social Cognitive Theory and five~     eating habits: consumption of fruits and vegetables, natural water, dairy products, sugary~     drinks and processed foods ; As well as anthropometric variables.~      The intervention group had twelve workshops on healthy eating habits and two sessions for~     parents. The control group received three sessions of nutritional information.~      All variables were measured again at the end of the intervention to evaluate results in the~     short term and three months later to know results in the medium term.~   "
27543|NCT03206463|"~     The overarching goal of this study is to characterize the acute cognitive and~     psychophysiological effects of the main psychoactive constituent of cannabis,~     9-delta-tetrahydrocannabinol (THC) in individuals with euthymic bipolar disorder (BD), and to~     begin probing the mechanisms that may underlie its effects in this illness.~      This study is expected to contribute to a better characterization of specific effects of THC~     in individuals with BD compared to healthy controls (HC).~   "
27544|NCT03206450|"~     This research trial studies saliva, semen, and blood samples to determine effects of~     chemotherapy on fertility in osteosarcoma survivors. Study biospecimen samples from~     osteosarcoma survivors in the laboratory may help doctors learn whether chemotherapy causes~     fertility problems and to learn more about the long term effects.~   "
27545|NCT03206437|"~     This study will evaluate the effects of Mindfulness-Based Stress Reduction (MBSR) on~     physiological reactivity. This study will focus on individuals with anxiety who will~     participate in an 8-week MBSR class. The investigators will test participants' reactivity to~     both predictable and unpredictable stimuli before and after the class to understand the~     physiological changes that may occur after to the intervention. Secondary measures include~     psychometric instruments and a delay discounting task.~   "
27546|NCT03206424|"~     WHO and UNICEF recommend exclusive breastfeeding for six months and addition of complementary~     foods (CF) at six months of age with continued breastfeeding till two years But WHO estimates~     that 2 out of 5 children are stunted in low-income countries, so CF should be timely,~     adequate and prepared and given in a safe manner.~   "
27547|NCT03206411|"~     -  Addiction to drugs and alcohol is increasingly becoming a worldwide trend that is~          prevalent in both rich and poor countries . Substance abuse shows a significant warming~          to the health, social and economic build of families, communities and nations. Extent of~          worldwide psychoactive substance use is estimated at 2 billion alcohol users and 185~          million drug users .~        -  Substance abuse (including alcohol and drugs) is an important risk factor for poor~          health globally due to their intoxicating effects or their toxic effects on organs and~          tissues that lead to the development of diseases, injuries and other health conditions~        -  Drug abuse is associated with the increased risk of cardiovascular diseases. A study on~          the need for hospitalization in approximately 4800 drug users found that 223 of these~          were admitted to hospital due to cardiovascular diseases .~        -  The majority of abused substances or their metabolites are excreted through the kidneys~          and renal complications of drug abuse are very common .The involvement of the kidney due~          to drug abuse is either attributed to their elimination through the kidney, or a direct~          nephrotoxic effect. The damage may be acute and reversible, or chronic and can leads to~          end stage renal failure .~        -  Addiction is responsible for different types of liver diseases including fatty liver,~          hepatitis and liver failure. . Intravenous drug addiction by sharing of contaminated~          needle is very important risk factor for the development of liver diseases, particularly~          hepatitis B and hepatitis C. Globally, 90% of new hepatitis C infections are attributed~          to drug injection . In the long run, substance abuse has negative effects on sexual~          functions and leads to the onset of sexual disorders. .~        -  Long term use of alcohol was reported to inhibit of hypothalamic-pituitary-adrenal axis~          and reduces the release of gonadotropins from the pituitary . Morphine administration~          suppresses LH release and reduces the levels of testosterone, which affects testicular~          function.~   "
27548|NCT03206398|"~     Non-operative treatment of pelvic fractures is possible. Immobilisation implies different~     adjustment processes. Patients with pelvic ring fractures and partial weight bearing have to~     obtain theses. The aim of this pilot study was to prove the additional effect of the~     anti-gravity treadmill in patients with non-operatively treated pelvic fractures.~   "
27549|NCT03206385|"~     The present register has been designed to confirm the hypothesis that while using high~     quality Intensity Modulated Radiation Techniques (IMRT) and a reduced external beam~     stereotactic boost component it would be possible to maintain the late severe toxicity rates~     under the 5 % level in situations where brachytherapy could not be proposed as a boost.~   "
27550|NCT03206372|"~     Young women have an increased risk of venous thromboembolism (VTE) during hormonale exposure~     (estrogen-containing pill or pregnancy). In order to detect women at higher risk of VTE~     during hormonal exposure, thrombophilia testing is often performed in order to adapt~     contraception methods and/or to increases thromboprophylaxy during pregnancy. However, such~     practice is probably not accurate nor discriminent. Indeed, there are evidence that the~     impact of the familial history of VTE might be stronger than that of detectable inherited~     thrombophilia.~      The FIT-H study is a cross-sectional study comparing the prevalence of previous venous~     thromboembolism in first-degree relatives of women (propositi) who had a first episode of~     venous thromboembolism in association with hormonal exposure with the prevalence of previous~     venous thromboembolism in first-degree relatives of women who did not have venous~     thromboembolism during a similar hormonal exposure.~      The primary objective is to determine the association between the presence or the absence of~     VTE in young women during hormonal exposure and the presence or the absence of a previous~     episode of VTE in their first-degree relatives. Secondary objective is to determine the~     impact of associated inherited thrombophilia on the risk of VTE in first-degree relatives.~   "
27553|NCT03206333|"~     The aim of the BRAGATSTON study is to provide a low cost tool for measuring CAC in breast~     cancer patients, thereby identifying patients at increased risk of CVD. Breast cancer~     patients and doctors can act upon this, by adapting the treatment and/or by adopting~     cardioprotective interventions. Hereby, the burden of CVD in breast cancer survivors can be~     reduced and better overall survival rates can be achieved.~   "
32439|NCT03142412|"~     To develop a test to characterize and monitor SLE disease activity status from a~     participant's home by analyzing the gene expression from participant self-collected blood~     samples using a novel fingerstick collection kit.~   "
27554|NCT03206320|"~     Skin infiltration with local anesthetic is commonly used to decrease patient discomfort~     during peripheral nerve blocks. Topically applied local anesthetic gel might provide~     analgesia while eliminating the need for additional injections. The primary objective of this~     study was a noninferiority comparison between the analgesia achieved with topical gel with~     that of skin infiltration for pain upon needle insertion and injection during administration~     of the interscalene brachial (ISBP) and axillary (AX) plexus blocks.~   "
27555|NCT03206307|"~     Can professional performance and the probability of returning to work up to three years after~     medical rehabilitation be predicted by spiroergometric data (or performance of the~     cardiovascular system) together with psychological factors (motivation, self-efficacy) as~     well as physical activity, and their interaction? How are work related and health related~     factors associated with the The following variables: workload, work satisfaction, personal~     assessment of the professional future and psychological stress?~   "
27556|NCT03206294|"~     The coverage of the diabetes is a multidisciplinary care, with practitioners'~     implication(hospital and liberal), and other medical and paramedical profession: doctor,~     pharmacist, male nurse, nutritionist, etc. In fact there is a real importance of link between~     hospital and general medecine outside. That's why the pharmacist's presence during the~     hospitalization seems to be a good alternative to make the link between hospital and the~     outside pharmacist where patient take his treatment.~      Hospital pharmacis proceed to a treatment conciliation at the entrance and at discharge.~      By this conciliation the aim of the study is to show and quantify the impact of pharmacist~     presence on therapeutic target .~   "
27557|NCT03206281|"~     To investigate the difference of clinical VS sonographic fetal weight estimation of tall~     women stature (above 10t percentile)~   "
27558|NCT03206268|"~     The aim of this study is to evaluate the correlation of retinal nerve fiber layer (RNFL)~     thickness measured using spectral domain optical coherence tomography (SD-OCT) and scanning~     laser polarimetry (SLP) in uveitic eyes compared to healthy eyes.~      A descriptive, observational, prospective, consecutive, cross-sectional, controlled,~     mono-center case series was conducted from May to October 2015. Clinical characteristics,~     best-corrected visual acuity, intra-ocular pressure, RNFL thickness measurement with SD-OCT~     and SLP using GDx variable corneal compensation (GDx VCC) were performed for each patient. An~     evaluation of anterior chamber inflammation with laser flare cell meter was also carried out.~     Correlations between SD-OCT and GDx VCC RNFL measurement were evaluated by linear regression~     analysis.~   "
27559|NCT03206255|"~     The primary objective of this study is to evaluate the immuno-persistence (type specific IgG~     antibody) of the tested vaccine administered in girls aged 9-17 years ,comparing to young~     healthy adults of 18-26 years who received the standard 3-dose schedule (0,1,6 months).~   "
27560|NCT03206242|"~     Head and neck cancer is prevalent in Taiwan, and oral cancer is the most common location.~     Patients with advanced stage of the disease need extensive tumor excision with neck~     dissection. Secondary reconstructive surgeries using free flap could improve the~     postoperative function or appearance of cancer survivors. Advanced treatments make survival~     rates increased. Effects of treatment for oral cancer develop shoulder dysfunction, speech,~     mastication, donor site morbidity and psychological issues. Physical therapy may have~     benefits for temporomandibular joint function, shoulder pain relief, muscle performance, and~     oral structures coordination. Return to work in the number of cancer survivors is a realistic~     outcome. Rehabilitation effects on functional restorations and quality of life for head and~     neck survivors are needed for further studied.~      The purpose of this project is to explore the rehabilitation effects following head and neck~     reconstructive survivors. The investigators measure temporomandibular joint function,~     shoulder function, pain monthly. Physical functions, self-reported quality of life, and the~     status of return to work are measured 3 and 6 months after surgery. This prospective study~     could help to predict the rehabilitation outcomes and benefits.~   "
27561|NCT03206229|"~     This is a single or up to 2 centers, double-blind, randomized, single-dose, two-way,~     crossover study comparing the Test (T) and Reference (R) products following subcutaneous~     administration. Subjects will be randomly assigned to one of two treatments sequences (TR or~     RT).~      All subjects will be dosed at the CRO's designated clinical site(s) and the same protocol~     requirements and procedures will be followed within each group.~   "
27562|NCT03206216|"~     This clinical trial studies how well Diode laser fiber type selective stimulator works in~     predicting pain development in patients with ovarian cancer who are receiving chemotherapy.~     Stimulating of the pain nerve fibers in your skin with an investigational device using laser~     light stimulation may help to predict whether a patient will develop painful peripheral~     neuropathy, correlate with the severity of neuropathy during and after chemotherapy~     treatment, and may help to explain the mechanisms of chemotherapy induced neuropathic pain.~   "
27563|NCT03206203|"~     This randomized phase II trial studies how well carboplatin with or without atezolizumab~     works in treating patients with stage IV triple negative breast cancer. Drugs used in~     chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Monoclonal antibodies, such as atezolizumab, may interfere with the ability of~     tumor cells to grow and spread. Giving carboplatin with atezolizumab may work better in~     treating patients with stage IV triple negative breast cancer~   "
27564|NCT03206190|"~     Study goals~        1. Prospective longitudinal data on progression in the natural course of SPG4 in~          presymptomatic mutation carriers prior to clinical disease onset and in early stages of~          disease~        2. Biomarkers providing objective measures of disease activity~   "
27565|NCT03206177|"~     This is a Phase 1 B feasibility trial with Galunsertib, a TGFβ inhibitor, in combination with~     carboplatin/paclitaxel in patients with newly diagnosed, persistent or recurrent~     carcinosarcoma of the uterus or ovary. The objective of the study is to determine whether~     this drug combination is safe for this patient population and to see if it is effective in~     shrinking cancers, keeping them from growing or helping patients live longer.~   "
27578|NCT03206008|"~     Evaluating analgesic effect of intraoperative magnesium sulfate infusion in the outpatient~     surgery case~   "
30942|NCT03162029|"~     This study will be observational study. The goal of this study is to evaluate the quality of~     mandible and to assess the correlation between the jaw bone quality in a sample of Egyptian~     patients with chronic renal failure and duration of dialysis using CBCT.~   "
27566|NCT03206164|"~     The barriers faced by people with intellectual and developmental disabilities (IDD) begin in~     their mid to late 20s and often mirror the experiences of older adults (50+) living in the~     U.S. While evidence for successful population-specific health promotion programs and~     training, such as the 12-Week HealthMatters Program has been documented, an urgent need~     exists for continuous, readily available, on-demand training in these programs. Online~     training can substantially aid the widespread translation of evidence-based programs into~     practice and policy. This proposal seeks to test the effectiveness of an enhanced mode of~     translating the HealthMatters program into practice through the use of an on-demand~     e-Learning platform (HealthMatters@24/7) for staff in community based organizations (CBOs) in~     one state; thereby advancing the science of translational research. HO1. More CBOs in the~     asynchronous training program will have developed Strategic Action Plans for Health and~     Wellness, established Wellness Committees, and have equal or more resources and improved~     culture for health promotion at 1 year compared to CBOs participating in the current live~     HealthMatters TtT Workshop webinar. HO2. Staff in the asynchronous training group will have~     improved levels of learner/instructor satisfaction (job productivity, job performance, job~     satisfaction, organizational commitment, convenience) toward the training immediately after~     completing the enhanced mode of training, HM@24/7 compared to staff trained using the current~     live HealthMatters TtT Workshop webinar.~   "
27567|NCT03206151|"~     Drugs used against cancer work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Monoclonal antibodies, such as CMAB009,~     can block tumor growth in different ways. Giving combination chemotherapy together with~     CMAB009 as first treatment after diagnosis of a metastatic colorectal cancer（first-line~     treatment）may improve the treatment efficacy. However, it is not yet known whether giving~     combination chemotherapy together with CMAB009 is more effective than combination~     chemotherapy alone. This open-label trial investigates the effectiveness of CMAB009 in~     combination with a standard and effective chemotherapy FOLFIRI（5-Fluorouracil /Folinic acid~     plus Irinotecan）for RAS/BRAF wild-type, metastatic colorectal cancer in first-line setting,~     compared to the same chemotherapy alone.~   "
27568|NCT03206138|"~     This is a study to investigate the safety and efficacy of GX-188E administered IM plus local~     administration of GX-I7 or Imiquimod at cervix in subjects with cervical intraepithelial~     neoplasia (CIN) 3.~   "
27569|NCT03206125|"~     Background:~      Esophageal cancer is a common cause of cancer deaths. Most cases of this cancer are~     esophageal squamous cell carcinoma (ESCC). Many of these cases come from two parts of the~     world with high-risk. One of these is in East Africa and include the country of Malawi.~     Researchers want to learn what factors explain the high risk there so we can understand~     better what causes this cancer in people everywhere.~      Objective:~      To learn more about causes and outcomes of esophageal squamous cell carcinoma using Malawi~     because of the large number of cases in that country.~      Eligibility:~      Adults at least 18 years old who have ESCC and live in a certain region of Malawi~      Adults in the same age group and location who do not have ESCC~      Design:~      Participants will be screened at a hospital in Malawi.~      Participants will have a 1-hour interview. They will answer questions about:~      Demographics (age, ethnicity, education)~      Place of residence~      Medical history and family medical history~      Drug, alcohol, and tobacco use~      Hot beverage consumption~      Indoor air pollution~      Occupation~      Food habits~      Farming~      Gastrointestinal health~      Participants will have their teeth and fingernails examined.~      Participants will be asked to give samples of blood, urine, saliva, toenails, and for the~     cancer cases, a small piece of their tumor.~      Participants will have 4 phone calls a year for 2 years to ask about their health....~   "
27570|NCT03206112|"~     Background~      Focal dystonia is a brain disorder. It affects a muscle or muscles in a specific part of the~     body. Researchers think it may be related to excessive training or practice. They want to~     know more about how much training might trigger focal dystonia.~      Objectives:~      To study why people develop focal dystonia. To study how brain plasticity changes with focal~     dystonia.~      Eligibility:~      People at least 18 years of age with focal dystonia.~      Healthy volunteers the same age are also needed.~      Design:~      Participants will be screened with a physical exam and questions. They may have blood and~     urine tests.~      Participants will have up to 3 testing visits.~      Participants will have small electrodes stuck on the skin on the hands or arms. Muscle~     activity will be recorded.~      Participants will have transcranial magnetic stimulation (TMS). A wire coil will be placed~     onto the scalp. A brief electrical current will pass through the coil. The current will~     create a magnetic field that affects brain activity.~      Participants may be asked to tense certain muscles or do simple actions during TMS.~      A nerve at the wrist will get weak electrical stimulation. The stimulation may be paired with~     TMS for very short times.~      Participants will receive repeated magnetic pulses. Participants will receive a total of 150~     pulses during a 10-second period. An entire testing visit will last about 3 hours.~   "
27571|NCT03206099|"~     Background:~      Genetic testing called sequencing helps researchers look at DNA. Genes are made of DNA and~     are the instructions for our bodies to function. We all have thousands of genes. DNA variants~     are differences in genes between two people. We all have lots of variants. Most are harmless~     and some cause differences like blue or brown eyes. A few variants can cause health problems.~      Objective:~      To understand the genetics of immune disorders.~      Eligibility:~      People ages 0 99 who are have a disease under investigation by another NIAID study that they~     are enrolled in~      Relatives of those people~      Design:~      Participants will give a sample by one of several means.~      Blood drawn by needle, or~      Saliva spit into a tube, or~      A couple of hairs plucked from the head, or~      A fingernail clipping.~      Researchers will study the genes from the samples. They will tell participants if they find~     results that relate to:~      The participant s (or family s) immune disorder~      Serious treatable diseases (like inherited cancer or heart disease)~      Some uncertain clinical results~      Researchers will not routinely tell participants about results that relate to normal variants~     or disorders that can t be treated.~      The samples and data will be saved for future research.~      Personal data will be kept as private as possible.~      If future studies need new information, participants may be contacted.~   "
31248|NCT03158051|"~     This is a 5-year randomized controlled trial in two large healthcare systems (Madison and~     Milwaukee, WI) to evaluate MyHEART's (My Hypertension Education And Reaching Target) impact~     on blood pressure among 310 geographically and racially/ethnically diverse young adults.~   "
27572|NCT03206086|"~     Background:~      Fanconi anemia is a genetic disease. Some people with it have reduced blood cell counts. This~     means their bone marrow no longer works properly. These people may need blood transfusions~     for anemia (low red blood cells) or low platelet counts or bleeding. Researchers want to see~     if a new drug will help people with this disease.~      Objective:~      To find out if a new drug, eltrombopag, is effective in people with Fanconi anemia. To know~     how long the drug needs to be given to improve blood counts.~      Eligibility:~      People at least 4 years old with Fanconi anemia with reduced blood cell counts.~      Design:~      Participants will be screened with blood and urine tests. They will repeat this before~     starting to take the study drug.~      Participants will take eltrombopag pills by mouth once a day for 24 weeks. They will be~     monitored closely for side effects.~      Participants will have blood tests every 2 weeks while on eltrombopag.~      Participants will visit NIH 3 months and 6 months after starting eltrombopag. At these~     visits, participants will:~      Answer questions about their medical history, how they are feeling, and their quality of life~      Have a physical exam~      Have blood and urine tests~      Have a bone marrow sample taken by needle from the hip. The area will be numbed.~      If participants blood cell counts improve, they might join the extended access part of the~     study. They will continue taking eltrombopag for 3 years and sign a different consent.~      After 24 weeks of treatment, if there is no improvement in blood cell counts, participants~     will stop taking eltrombopag. They will return for an optional follow-up visit that repeats~     the study visits.~   "
27573|NCT03206073|"~     Background:~        -  Immune-based approaches in colorectal cancer have unfortunately with the notable~          exception of immune checkpoint inhibition in microsatellite instable (MSI-hi) disease~          been largely unsuccessful. The reasons for this are unclear but no doubt relate to the~          fact that in advanced disease colorectal cancer appears to be less immunogenic, as~          evidenced by the lack of infiltrating lymphocytes with advancing T stage~        -  Pexa-Vec (JX-594) is a thymidine kinase gene-inactivated oncolytic vaccinia virus~          engineered for the expression of transgenes encoding human granulocyte- macrophage~          colony-stimulating factor (GM-CSF) and beta-galactosidase. Apart from the direct~          oncolytic activity, oncolytic viruses such as Pexa-Vec have been shown to mediate tumor~          cell death via the induction of innate and adaptive immune responses~        -  Tremelimumab is a fully human monoclonal antibody that binds to CTLA-4 expressed on the~          surface of activated T lymphocytes and causes inhibition of B7-CTLA-4-mediated~          downregulation of T-cell activation. Durvalumab is a human monoclonal antibody directed~          against PD-L1.~        -  The aim of the study is to evaluate whether the anti-tumor immunity induced by Pexa-Vec~          oncolytic viral therapy can be enhanced by immune checkpoint inhibition.~      Objective:~      -To determine the safety, tolerability and feasibility of Pexa-Vec oncolytic virus in~     combination with immune checkpoint inhibition in patients with refractory metastatic~     colorectal cancer.~      Eligibility:~        -  Histologically confirmed metastatic colorectal cancer.~        -  Patients must have progressed on, been intolerant of or refused prior oxaliplatin- and~          irinotecan-containing, fluorouracil-based, chemotherapeutic regimen and have disease~          that is not amenable to potentially curative resection. Patients who have a known KRAS~          wild type tumor must have progressed, been intolerant of or refused cetuximab or~          panitumumabbased chemotherapy.~        -  Patients tumors must be documented to be microsatellite-stable (MSS) either by genetic~          analysis or immunohistochemistry OR microsatellite-high with documented disease~          progression following anti-PD1/PDL1 therapy.~        -  Patients must have at least one focus of metastatic disease that is amenable to pre- and~          ontreatment biopsy.~        -  Willingness to undergo mandatory tumor biopsy.~      Design:~      -The proposed study is Phase I/II study of Pexa-Vec oncolytic virus at two dose levels in~     combination with immune checkpoint inhibition in patients with metastatic colorectal cancer.~   "
27574|NCT03206060|"~     Background:~      Pheochromocytoma and paraganglioma are rare tumors. They usually form inside and near the~     adrenal gland or in the neck region. Not all these tumors can be removed with surgery, and~     there are no good treatments if the disease has spread. Researchers think a new drug may be~     able to help.~      Objective:~      To learn the safety and tolerability of Lu-177-DOTATATE. Also, to see if it improves the~     length of time it takes for the cancer to return.~      Eligibility:~      Adults who have an inoperable tumor of the study cancer that can be detected with~     Ga-68-DOTATATE PET/CT imaging~      Design:~      Participants will be screened with a medical history, physical exam, and blood tests.~      Eligible participants will be admitted to the NIH Clinical Center.~      Participants will get the study drug in an intravenous infusion. They will get 4 doses, given~     about 8 weeks apart.~      Between 4 and 24 hours after each study drug dose, participants will have scans taken. They~     will lie on their back on a scanner table.~      Participants will have vital signs taken. They will give blood and urine samples.~      During the study, participants will have other scans taken. Some scans will use a radioactive~     tracer.~      Participants will complete quality of life questionnaires.~      Participants will be contacted by phone 1-3 days after they leave the Clinical Center. They~     will then be followed every 3 to 6 months for 3 years or until their disease gets worse.~   "
27575|NCT03206047|"~     This randomized phase I/IIb trial studies side effects and best dose of atezolizumab when~     given together with guadecitabine and CDX-1401 vaccine and to see how well they work in~     treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come~     back. Monoclonal antibodies, such as atezolizumab, may block tumor growth in different ways~     by targeting certain cells. CDX-1401 vaccine may enhance the expression of the genes encoding~     tumor antigens on the surface of tumor cells and enhance the activity of tumor-killing T~     cells against those tumor cells. Vaccines made from monoclonal antibodies combined with tumor~     cells may help the body build an effective immune response to kill tumor cells. Giving~     atezolizumab, guadecitabine, and CDX-1401 vaccine may work better in treating patients with~     ovarian, fallopian tube, or primary peritoneal cancer.~   "
27576|NCT03206034|"~     Impairments in higher level cognitive processing, such as new learning and memory, are common~     in Multiple Sclerosis (MS) and negatively impact multiple aspects of everyday life, including~     occupational and social functioning. Despite this, few studies have attempted to remediate~     these cognitive deficits in order to improve everyday functioning. While not applied in~     traditional rehabilitation protocols as of yet, many techniques from cognitive psychology~     significantly improve learning and memory in healthy persons. These techniques include the~     generation effect (GE), the spacing effect (SE), and the testing effect (TE). These~     techniques have recently been incorporated into an 8-session treatment protocol, Stylistic~     Memory Enhancement (SME), designed to teach participants about each of the techniques, train~     them on how to apply the techniques in daily life and practice their application to daily~     life memory demanding situations. The protocol includes teaching participants how to~     restructure a memory demanding situation in order to make optimal use of self-generation,~     spaced learning and self-testing. The objective of the study is to test the efficacy of the~     SME in an MS population.~   "
27577|NCT03206021|"~     Many pediatric brain and solid tumors have altered epigenetic landscapes, and altered DNA~     methylation. As such this study is a Phase I/Ib study of combined 5'Azacitidine with an~     escalating dose of carboplatin for all recurrent/refractory pediatric brain and solid tumors.~     The phase I component will establish with maximum tolerated dose of carboplatin with~     azacytidine. An expansion cohort will be recruited of up to 30 patients will follow~     consisting of 20 recurrent posterior fossa ependymoma and 10 recurrent supratentorial~     ependymoma.~   "
27580|NCT03205982|"~     The overall goal of this study is to design a user-centered design app linked to a smart pill~     box for people living with HIV (PLWH) and evaluate its effects in a randomized controlled~     trial. The proposed trial is scientifically significant in representing a principled and~     systematic effort to test the efficacy of a smartphone intervention linked to a smart pill~     box for antiretroviral (ART) adherence in PLWH in the United States (US). Guided by a strong~     theoretical framework building on earlier user-centered design work and integrating a~     real-time monitoring device, this work has the potential to improve ART adherence in PLWH and~     have a sustainable public health impact.~   "
27581|NCT03205969|"~     The purpose of this study is to determine whether functional games can be used to improve the~     adherence and quality of life of breast cancer patients with chemotherapy.~   "
27582|NCT03205956|"~     The Measuring Parkinson's Disease Progression study aims to use MRI scans and a controlled~     dose of levodopa to find a biomarker (objective measurement) of Parkinson's disease (PD).~     Biomarkers would help determine the effectiveness of therapies in slowing or stopping PD~     progression, and accelerate the pace of research.~   "
27583|NCT03205943|"~     To collect and analyze the physiologic data of the ICON™ during dexmedetomidine (DEX)~     sedation for neonatal pulmonary function testing. The ICON™ is a noninvasive physiological~     monitor which uses respiratory impedance to follow systemic vascular resistance (SVR), heart~     rate, cardiac index and stroke index.~   "
27584|NCT03205930|"~     Neoantigen （Neo）is a new targets for immune cells，that the DC neoantigen immunotherapy was~     more effective in triggering specific T-cell responses. Neo-MASCT using the DC vaccine and~     neoantigen T cells .Dendritic cells(DC) was induced from autologous peripheral blood，and be~     loaded with antigens and re-infused. In vitro, antigen-pulsed DC can stimulate autologous~     T-cell proliferation and induction of autologous specific cytotoxic T-cells(CTL)，similarly~     re-infused.~      The study is aimed to evaluate the safety of Neo-MASCT in patients with advanced NSCLC.~   "
27585|NCT03205917|"~     This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and anti-viral~     efficacy of the PGDM1400 and PGT121 mAbs for HIV prevention and therapy.~   "
27586|NCT03205904|"~     Cystic fibrosis (CF) is a genetic disease with an autosomal recessive, chronic and~     progressive character about 10 to 25% of patients develop CF-related diabetes (DRFC). Until~     now, there is no evidence to support the use of low glycemic index diet to improve glycemic~     response in pre-diabetic and CF patients. The objective of this study is to evaluate the~     glycemic improvement after nutritional orientation in patients with cystic fibrosis.~   "
27587|NCT03205891|"~     The goal of this clinical research study is to find the highest tolerable dose of TAK228 that~     can be given in combination with brentuximab vedotin in patients with lymphoma. The safety of~     this combination will also be studied.~      This is an investigational study. TAK228 is not FDA approved or commercially available. It is~     currently being used for research purposes only. Brentuximab vedotin is FDA approved and~     commercially available for the treatment of different types of lymphoma. The study doctor can~     explain how the study drugs are designed to work.~      Up to 18 participants will be enrolled in this study. All will take part at MD Anderson.~   "
27588|NCT03205878|"~     Patients with obstructive sleep apnea (OSA) are less physically active than healthy controls.~      First choice of treatment for OSA is continuous positive airway pressure (CPAP) therapy with~     an improvement in oxygen saturation and sleep. No improvement on physical activity has been~     shown.~      The current study would randomize patients in a standard care group (CPAP) and an~     intervention group (CPAP + telecoaching). Telecoaching will be performed for 3 months, with~     physical activity assessment before, after 3 months and 12 years.~   "
27589|NCT03205865|"~     Type 1 diabetes (T1D) affects 1.4 million people in the U.S. and its incidence has doubled~     over the past 20 years. The Diabetes Autoimmunity in the Young Study (DAISY) will estimate~     overall burden of T1D and other autoimmune diseases in the general population by age 30. The~     study will evaluate environmental risk factors for development of islet autoimmunity and~     progression to T1D.~   "
27590|NCT03205852|"~     The objective of this study was to evaluate the effect on patient treatment decision-making~     if information was given based on the benefit or on the side effect in rotator cuff~     disorders.~   "
27591|NCT03205839|"~     The acceptance and commitment therapy (ACT) model theoretically fits with treating~     appearance-related anxiety in individuals with a visible difference. This study examines the~     effectiveness of an acceptance-based self-help manual for this population.~   "
27592|NCT03205826|"~     Rationale: The Chartis® ( Pulmonx, CA, USA) measurement system is a tool to assess interlobar~     collateral ventilation during bronchoscopy. Assessing collateral ventilation is important~     when you intend to treat a patient with endobronchial valves. Chartis measurement of~     collateral ventilation can be performed under both conscious sedation as well as general~     anesthesia. There is no consensus on what is the preferred method of anesthesia for Chartis~     measurements in the literature.~      Objective: In this project we want to investigate whether there is a difference in Chartis~     measurement outcomes between these two methods of anesthesia: conscious sedation and general~     anesthesia.~      Study design: This study will be a single center observational study~      Study population: The study population exists of patients with severe emphysema who undergo~     collateral ventilation assessment before bronchoscopic lung volume reduction treatment with~     one-way endobronchial valves.~      Intervention: All patients will undergo two subsequent Chartis measurements. The first~     measurement will be performed with the patient undergoing conscious sedation and the second~     measurement with the patient under general anesthesia.~      Main study parameters/endpoints: Our primary outcome measure is the failure rate of the~     Chartis collateral ventilation measurement under general anesthesia versus conscious~     sedation.~   "
27650|NCT03205059|"~     This Phase II SBIR project is designed to address the critical public health problem of~     bullying and cyberbullying among middle school age youth. The project involves developing and~     testing bullying and cyberbullying prevention materials, including interactive classroom~     sessions and corresponding serious games, based on the evidence-based substance abuse~     prevention approach called Life Skills Training. The product has the potential to fill a gap~     in the intervention tools currently available to schools that can be widely disseminated~     throughout the country using existing marketing and dissemination channels and decrease the~     adverse consequences of bullying and cyberbullying as well as substance abuse.~   "
27593|NCT03205813|"~     Spinal block with intrathecal morphine is a popular anesthetic technique in cesarean~     delivery. This technique brings about good maternal and neonatal outcomes as well as provides~     good postoperative pain control. Systematic review showed intrathecal morphine produced long~     period of pain control up to 27 hours. However, some patients still experienced moderate to~     severe pain which defined as postoperative pain score >,= 4. From our institute survey, there~     were more than 50 percents of patients undergoing cesarean delivery receiving spinal block~     with intrathecal morphine experienced moderate to severe pain in the first 24 hours.~      The aim of the study is to determine the actual incidence and associated factors of patients~     whom experienced moderate to severe pain after spinal anesthesia with intrathecal morphine~     200 mcg in cesarean delivery.~   "
27594|NCT03205800|"~     Alveolar bone is a bony portion surrounding the root of a tooth. The alveolar bone disappears~     gradually when the tooth is extracted. This bone loss often becomes a problem if a patient~     wants to close the missing tooth space with orthodontic treatments (braces), or to get a~     dental implant (a metal post replacing a tooth). Therefore, we would like to place small~     screws at the extraction sites to preserve the alveolar bone when the teeth need to be~     extracted and a patient cannot start treatments some time.~      Mini-screws (small metal screws) are routinely used for regular orthodontic treatment. We~     will recruit patients who require extractions of two upper small molars (maxillary premolars)~     on both right and left sides. We will place one mini-screw on one side while the other side~     will be untouched after teeth extractions. Both sides will be followed at 4 months and 8~     months for examinations.~   "
27595|NCT03205787|"~     Human safety studies will be carried out to test whether red clover botanical dietary~     supplements used by peri- and post-menopausal women are safe to use with Food and Drug~     Administration (FDA)-approved drugs. To test this, a red clover dietary supplement~     (previously tested in women at the University of Illinois at Chicago without any harmful~     effects) will be given with four selected FDA-approved drugs to determine if the red clover~     supplement can increase or decrease how these medications are absorbed, metabolized and~     excreted by the human body. Preclinical studies predict that the red clover supplement might~     affect the metabolism or break down of these probe drugs.~   "
27596|NCT03205774|"~     The aim of this prospective study was to assess the effect of patient positioning on the~     ultrasound assessment of gastric contents.~   "
27597|NCT03205761|"~     This is a multicenter single-arm phase II clinical trial to evaluate the efficacy and safety~     of olaparib in patients diagnosed of advanced triple negative breast cancer (TNBC) with~     methylation of BRCA1 and/or BRCA2 promoters assessed in DNA from metastatic lesions and~     absence of BRCA1 and 2 germline mutations.~      Patients must have received at least one previous regimen in the advance disease setting and~     must have at least one measurable lesion that can be accurately assessed according to RECIST~     v.1.1. Potential eligible patients will be screened to assess somatic (s) BRCA promoter~     methylation at an reference central laboratory. Germinal (g) BRCA mutational status will be~     analyzed also centrally at Myriad GmBh laboratory unless the BRCA mutational status is~     already known based on a Myriad previous report. Patients with a positive methylation status~     on at least one of the two genes and lacking of known deleterious or suspected deleterious~     mutations in both genes could be enrolled in the study and receive olaparib.~      Blood and tumor samples collected from all screened patients could be used for the biomarker~     analysis, including the assessment of germline methylation status and gene expression levels~     of BRCA1/2. An early efficacy review will be performed after 12 evaluable patients are~     enrolled; if at least 4 of them show tumour response, additional patients will be included to~     complete a total of 34 patients.~   "
27598|NCT03205748|"~     Ascites refers to fluid that accumulates within the peritoneal cavity. Although ascites is~     most commonly observed in patients with cirrhosis and resulting portal hypertension~     (approximately 85% of cases), 7% to 10% of patients with ascites develop secondary to a~     malignancy~   "
27599|NCT03205735|"~     An observational study of a prospective, analytical, monocentric cohort which does not modify~     the patient care because the phenotyping of the dihydropyrimidine déshydrogénase DPD~     (lymphocyte activity) is already carried out in routine hospital. The analysis will be based~     on clinical, radiological and biological criteria.~   "
27600|NCT03205722|"~     A retrospective, observational study based on chart reviews for patients with advanced~     melanoma treated with nivolumab monotherapy prescribed as first-line therapy between June~     2015 and June 2016, conducted in a representative sample of sites in Germany.~   "
27601|NCT03205709|"~     The purpose of this study is to evaluate if systematic cognitive training can improve~     cognitive performance in participants (55 and older) with memory loss. This study will~     evaluate the effects of Computerized Cognitive Training (CCT) for improvement in everyday~     cognitive and function status, in addition to long-term changes in brain networks over an~     18-month period. Although there is no distribution of medication for this study, participants~     are required to have an at-home computer.~   "
27602|NCT03205696|"~     This is a strategic prospective cohort study which will measure the effects of early~     intensive antiretroviral therapy (ART) on the establishment and persistence of HIV-1~     reservoirs and HIV-1-specific immunity in acutely /recently HIV infected youth aged 12 to 24~     years as compared to newly diagnosed youth with established infection > 6 months.~     Participants with newly diagnosed acute /recent HIV-1 infection will be offered enrollment~     into the study with immediate initiation of ART which is the current standard of care.~   "
27603|NCT03205683|"~     We hypothesize that a standard course of INF can result in significant improvement in CTS as~     measured by clinical, electrodiagnostic, or ultrasound measures.~   "
27604|NCT03205670|"~     This study investigates safety and efficacy of surgical treatment of patients with anterior~     urethral stricture using a tissue-engineered construct based on autologous buccal mucosa~     cells and matrix from reconstituted collagen and reinforcing polylactoglycolide fibers. This~     is a single arm study with no control. Success will be assessed via objective and subjective~     methods; complications will be tallied in a standardized fashion. Outcomes will be measured~     at five years.~   "
27605|NCT03205657|"~     The investigators plan to perform a retrospective review of patients with poor risk~     relapsed/refractory B-NHL having received HSCT and targeted immunotherapy at the Maria Fareri~     Children's Hospital between January 1, 2012 and June 1, 2015. The investigators will review~     the clinical records and collect the data with de-identified medical information from our~     HSCT clinical research database.~   "
27610|NCT03205579|"~     Cancer pain is one of the problems of treating cancer pain. Although, there is a WHO~     analgesic ladder to improve this problem, it is still inadequate pain control. Pain does not~     affect only physical but also emotional and quality of life.~      From review literatures we found that patients' knowledge about cancer pain management is~     inaccurate; for example, fear to use opioid, try to patience of pain, concerning only cancer~     treatments, which can cause of unfavorable pain management outcome.~      Therefore, we will conduct the RCT of using pain education by video comparing to conventional~     face to face pain education by nurse in hospitalized cancer pain patients.We will use 25 MCQs~     examination for testing pre-post intervention to test level of understanding of patients. The~     measurements are NRS, ThaiHADs and FACT-G at the first and last day of study. We expect that~     NRS should improve more than 50% at the seven day of study.~   "
27611|NCT03205566|"~     This study evaluates whether a 7-day course of Raltegravir 400mg bd or Raltegravir~     400mg/lamivudine 150mg bd can prevent HIV from infecting genital tissue and will relate the~     level of drug in the blood to the level of drug in genital tissue and to the ability to of~     HIV to infect genital tissue. As well as determining whether these regimes can provide ex~     vivo protection against HIV, this study will also determine speed to provision of protection~     and a 48 hour PK/PD decay profile of Raltegravir following drug cessation after attaining~     steady state concentrations. The results will also inform all future HIV pre-exposure~     prophylaxis studies of Raltegravir and form the basis for large scale clinical trials without~     the need for tissue sampling. To date, efficacy studies assessing PrEP regimens have utilized~     HIV-acquisition endpoints with the consequence being such studies are required to be large in~     subject number in order to power observations. In addition the study will provide for the~     first time data on HIV protection rather than just Raltegravir drug levels in tissue, and~     allow assessment of the possibility of Raltegravir being used as an intermittent dosing~     regimen in PrEP.~   "
27612|NCT03205553|"~     Gastroschisis is a clinical condition characterized by a defect in the normal development of~     the abdominal wall. The defect is present to the right of the umbilicus leading to in utero~     bowel evisceration and exposure to amniotic fluid. Prolonged exposure to amniotic fluid may~     lead to inflammatory changes and damage to the exteriorized bowel. After birth and prior to~     operation, the usual treatment consists of covering the bowel with impermeable plastic bag to~     prevent additional fluid losses and bowel desiccation. Subsequent operative intervention~     occurs either in the operating room or in the neonatal intensive care unit. Two surgical~     options include primary closure of the abdomen or placement of a silastic silo followed by~     subsequent closure several days later as a staged procedure. The main reason the abdominal~     wall is not closed initially is due to fear of abdominal compartment syndrome, a condition~     caused by high intra-abdominal pressures leading to respiratory and circulatory compromise.~     The key points of the initial surgery involve examining the intestine for any signs of~     atresia, bowel compromise, and either placement of the bowels back into the abdomen or a~     spring loaded silo.~   "
27613|NCT03205540|"~     This study evaluates postoperative analgesic efficacy within 48 hours between epidural~     analgesia and single-shot bilateral adductor canal blocks in bilateral total knee~     arthroplasty. Half of participants will be received continuous epidural analgesia, while~     other half of participants will be received single-shot bilateral adductor canal blocks.~   "
27614|NCT03205527|"~     The long-term objective of this research is to develop an efficacious training paradigm to~     enhance stroke survivors' defense mechanisms against falls and possibly reduce healthcare~     cost. The Centers for Disease Control and Prevention estimates the direct medical cost for~     fall related injuries to be $34 billion annually. Forty percent to 70% of community-dwelling~     stroke survivors experience detrimental falls each year and tend to have 1.5 to 4 times~     higher risk of hip fracture than their healthy counterparts; with only less than 40% of those~     individuals regaining independent mobility. Falls, thus not only affect activities of daily~     living but also reduce mobility, increase risk of second stroke and mortality. Despite~     potential financial and functional implications of falls in this population, health-care~     personnel are limited in their ability to develop and validate interventions to reduce~     fall-risk for them. Further emphasis is placed on locomotor training with focus on enhancing~     paretic limb function. The project design consists of a randomized controlled trial to~     examine the ability of chronic stroke survivors to acquire, generalize and retain adaptations~     to slip-perturbation training for not only mitigating fall risk but also improving walking~     function. It also explores translation of this paradigm to the sub-acute population. The~     paradigm is novel in that it targets contributions of the paretic vs. non-paretic limbs on~     fall-risk through a bilateral training paradigm that involves training the non-paretic side~     first and then paretic to facilitate acquisition of fall-prevention skills on the paretic~     side, which may otherwise take longer to acquire training effects. The longer-term benefits~     of such perturbation training, targeting both limbs for reducing falls will be assessed not~     only in the laboratory but also in real life via wearable sensors, along with improved~     community walking function. The hypothesis of this study if supported by the results will~     provide an evidence-supported training protocol to reduce the fall-risk not only in people~     living with hemiparetic stroke but also among survivors of other acquired unilateral cortical~     lesions.~   "
27615|NCT03205514|"~     Ten-fifteen percent of acute coronary syndromes without ST-segment elevation (NSTE-ACS) are~     caused by intermediate lesions without signs of unstable plaque. In this subset of patients,~     fractional flow reserve (FFR) has some drawbacks and may not be always able to predict~     outcome, especially when negative (above 0.80). In this particular nique of patients,~     advanced imaging techniques are suggested by International guidelines. However, it is~     actually unknown how these techniques may impact treatment strategies. With the present~     study, the investigators want to characterize the mechanism of disease in this particular~     subset of patients through multimodality imaging (intravascular ultrasound-near infrared~     spectroscopy (IVUS-NIRS), optical coherence tomography (OCT)) in order to understand the~     proper treatment.~   "
27616|NCT03205501|"~     To improve detection of esophageal (pre)malignant lesions during surveillance endoscopy of~     patients at risk of developing malignancies, for example in Barrett's Esophagus (BE), there~     is a need for better endoscopic visualization and the ability for targeted biopsies. Optical~     molecular imaging of neoplasia associated biomarkers could form a promising technique to~     accommodate this need. It is known that the biomarker c-Met is overexpressed in dysplastic~     and neoplastic areas in BE segments versus normal tissue and has proven to be a valid target~     for molecular imaging.~      Edinburgh Molecular Imaging Ltd (EMI) has developed a fluorescent tracer specifically~     targeting c-Met by labeling a small peptide to a fluorescent fluorophore: 'EMI-137'. The~     investigators hypothesize that when EMI-137 is administered intravenously, it accumulates in~     c-Met expressing high grade dysplasia (HGD) and esophageal adenocarcinoma (EAC), enabling~     (early) cancer visualization using a newly developed fluorescent fiber-bundle. This~     hypothesis will be tested in the current pilot intervention study.~   "
27617|NCT03205488|"~     This study will assess the safety and tolerability of daily oral administration of nilotinib~     (150-300mg once daily) in Parkinson's Disease.~   "
27618|NCT03205475|"~     This study will focus on examining the supports required to enable community Senior JASPER~     Trainers to support the training and development of junior interventionists throughout the~     province of Newfoundland and Labrador, Canada. The study will examine the training and~     supports delivered by Senior Trainers to help junior interventionists provide a targeted~     social communication intervention (JASPER: Joint Attention, Symbolic Play, Engagement, and~     Regulation) with children with autism spectrum disorder (ASD). Children's engagement, play,~     and social communication outcomes will be examined as well as the influence of junior~     interventionists' intervention implementation on children's outcomes. Further, the study will~     examine the supports required to help junior interventionists who demonstrate slower gains in~     implementation fidelity after the first three months of standard support. Interventionists~     who are slow to gain implementation fidelity will be randomized to either (a) enhanced~     feedback plus peer support or (b) enhanced feedback plus intensive refresher course.~   "
27619|NCT03205462|"~     The current Phase I clinical trial has been developed to assess the safety and tolerability~     of the Fluorothyazinone drug used as a single-dose administration and a treatment course in~     healthy volunteers. This dose-escalation trial will be conducted with sequential enrollment~     of volunteers.~   "
27620|NCT03205449|"~     Parenting for Lifelong Health (PLH) Philippines Evaluation Study: Multisite randomised~     controlled trial to compare the efficacy of a culturally-adapted parenting programme,~     Masayang Pamilya, versus services as usual in the reduction of child maltreatment and~     improvement of child wellbeing in low-income Filipino families with children aged two to six~     years in Metro Manila (N = 120).~      A previous study focused on adaptation and feasibility testing was conducted from January~     2016 to February 2017. Community-based participatory approaches were used to culturally adapt~     the Sinovuyo programme to a Filipino context. A formative evaluation using qualitative~     in-depth interviews and focus group discussions with parents, as well as consultative~     workshops with service providers and other stakeholders, examined issues regarding the needs~     and concerns of Filipino parents, appropriateness of intervention components and delivery,~     and other specific cultural issues in order to balance fidelity to evidence-based practices~     with fit to the local context [11]. The Sinovuyo programme was then adapted into the MaPa~     programme with local materials and approaches developed to fit the Philippine cultural~     context based on findings from the formative evaluation.~   "
27621|NCT03205436|"~     This study is an extension of the randomized controlled trial NT-DFU-AFF-01. Subjects that~     were randomized to the Standard of Care group will be able to crossover to the NT-DFU-AFF-02~     trial and receive Affinity fHSAM if certain criteria are met.~   "
27622|NCT03205423|"~     The present proposal will evaluate the ability of gabapentin maintenance to reduce the abuse~     liability of alcohol, oxycodone, and alcohol in combination with oxycodone in participants~     with both Opioid Use Disorder and Alcohol Use Disorder.~   "
27623|NCT03205410|"~     Remote ischemic preconditioning (RIPC), elicited by brief episodes of ischemia and~     reperfusion in distant tissue, offers a protection against acute kidney injury (AKI) in~     patients after cardiac surgery. Investigators conducted a prospective, randomized, controlled~     clinical trial to assess whether RIPC reduces the incidence of AKI measured by standard way~     using serum creatinine concentration (SCr) and with use of serum level of neutrophil~     gelatinase-associated lipocalin (NGAL) as a new potential biomarker of a kidney injury.~     Moreover the aim of investigation was to analyse the safety and clinical outcomes of RIPC~     after elective, isolated, primary off-pump coronary artery bypass graft surgery (OPCAB).~   "
27624|NCT03205397|"~     In France, during surgery, only 4% of parents are present at induction, most often for~     children with disabilities with iterative interventions. Some studies have shown that the~     presence of parents during induction decreases the anxiety of children, while others do not.~     Their conclusions all advocate preparing parents for this presence in the operating room in~     an accompanying course.~   "
27625|NCT03205384|"~     Morbimortality in older patients undergoing abdominal surgery.~   "
27626|NCT03205371|"~     This Phase III, open-label, randomized, parallel-group, active-controlled, multicenter study~     is conducted to assess the immunogenicity and safety of a single dose of MenACYW conjugate~     vaccine when administered alone and in combination with other pediatric vaccines in healthy~     toddlers in South Korea, the Russian Federation, and Mexico.~   "
27627|NCT03205358|"~     The purpose of the study is to evaluate the immunogenicity and safety profile of a single~     dose of MenACYW conjugate vaccine when given alone compared to that of the licensed vaccine~     NIMENRIX®.~      Observational objectives:~        -  To evaluate the antibody responses to the antigens (serogroups A, C, Y, and W) present~          in MenACYW conjugate vaccine and NIMENRIX® measured by serum bactericidal assay using~          baby rabbit complement (rSBA) and by serum bactericidal assay using human complement~          (hSBA)~        -  To evaluate the antibody responses against tetanus in subjects who received MenACYW~          conjugate vaccine or NIMENRIX vaccine~        -  To evaluate the safety profile of MenACYW conjugate vaccine and NIMENRIX®~   "
27628|NCT03205345|"~     This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the~     safety and efficacy of emricasan in improving event-free survival based on a composite~     clinical endpoint (where all-cause mortality, new decompensation events, and MELD score~     progression are events) in subjects with decompensated NASH cirrhosis.~   "
27651|NCT03205046|"~     This study evaluates the safety of acalabrutinib and vistusertib when taken in combination.~   "
27652|NCT03205033|"~     Breast cancer is the second most common cancer in the world, the most common in women,~     representing the leading cause of death in Brazil. The therapeutic approach for breast cancer~     includes surgery, radiotherapy, chemotherapy and endocrine therapy. Chemotherapy courses with~     side effects because the cytotoxic effects affect indistinctly neoplastic cells and normal~     cells. The cancer per se may promote disruption in circadian rhythm. Chemotherapy induces or~     enhances desynchronization of the sleep-wake cycle, which competes with impaired memory,~     mood, pain and poor quality of life. Melatonin is an attractive therapeutic option in this~     context. This neurohormone also has immunomodulatory, co-analgesic and anti-depressant~     properties. Additionally, the antioxidant properties of melatonin may decrease free radical~     formation, reducing damage to DNA. The objective is to assess the response to melatonin as a~     synchronizer of the sleep-wake rhythm, neuromodulator, and mieloprotetor genoprotetor in the~     effects induced by chemotherapy in women with breast cancer.~   "
27629|NCT03205332|"~     Generalized Anxiety Disorder (GAD) is a chronic condition whose hallmark feature is excessive~     and uncontrollable worry (American Psychiatric Association, 2013). Theories of GAD propose~     that specific cognitive biases are involved in the maintenance and etiology of chronic worry.~     One cognitive bias that plays a role in worrying is abstract thinking, or the tendency to~     verbalize thoughts and worries in a manner that is vague and lacking in detail. There is~     evidence that training depressed people to think more concretely improves depressive symptoms~     and depression-type thinking styles, and reduces emotional reactivity. Given that chronic~     worry and depression have commonalities (e.g., repetitive thinking styles, difficulties with~     problem-solving and attentional control, emotion dysregulation), concreteness training may~     help people who struggle with chronic worry. The main goals of this proof of concept~     experiment are 1) to test in individuals reporting chronic worry the effects of an active~     form of concreteness training that involves imagery practice (compared to a no training~     control condition) on frequency of worrying, problem solving quality, and worry-related~     processes; 2) to examine the degree to which concreteness training causes improvements in~     daily worry and negative affect during the 7 days of practice. The study design will provide~     us with an understanding on a more macro level of the potential short-term benefits and~     will at the same time allow us to see, on a more micro level, how training concreteness~     affects worry and mood on a day-to-day basis during a 7-day period. The findings from this~     study will inform relevant clinical literature about efficacious methods to reduce chronic~     worry.~   "
27630|NCT03205319|"~     Indigestion or dyspepsia is highly prevalent worldwide. Often these symptoms are of benign~     nature and subside without treatment, or with lifestyle interventions like dietary~     modifications. Too often, gastroscopy is performed because of dyspepsia. Although this is~     indicated when malignancy is suspected, in a substantial part of the cases the gastroscopy is~     not indicated and will not achieve clinically relevant results. It is suspected that~     gastroscopy is often used for reassurance of patients or as a 'last resort'.~      Our hypothesis is that adequate education of patients can replace this need for invasive~     measures. The aim of this study was therefore to reduce the volume of gastroscopies for~     dyspepsia, by offering patients an e-learning containing educational material on dyspepsia.~      During the trial, 400 dyspeptic patients, referred for gastroscopy by the GP, will randomly~     be divided into two groups: One group will receive the e-learning instead of gastroscopy~     (intervention), the other group will receive the gastroscopy (control).~      After a twelve week follow-up, change in symptom severity, disease specific quality of life~     and fear of disease will be compared between the two groups.~   "
27631|NCT03205306|"~     The purpose of the study is to systematically capture and characterize mental comorbidities~     for patients with myasthenia gravis. Anxiety disorders and depression for example, can~     negatively affect the quality of life and lead to e.g. unemployment and early retirement~     especially in young patients.~      Additionally the researchers want to find out in what way certain aspects of the disease have~     an influence on the quality of life, and whether different concepts of coping with the~     disease have different effects on the quality of life for patients with myasthenia gravis.~      During the study, close relatives of patients will also be asked to provide input about their~     current stress situation in the context of supporting their relative.~      Based on the results, the investigators want to improve and supplement established treatment~     concepts, to ensure a more comprehensive and individual treatment.~   "
27632|NCT03205293|"~     The purpose of this research is to develop, apply, and evaluate a school-based intervention~     program in East Jerusalem schools, designed to increase knowledge and to improve the~     attitudes and healthy behavior of schoolchildren, their teachers and their mothers' with~     regard to healthy eating and physical activity habits. The study tested the hypothesis that~     the impact of the entire school intervention program on students' lifestyles is mediated by~     their teachers' engagement in health promotion and by their mothers' involvement in school~     activity.~   "
27633|NCT03205280|"~     1. Background The results obtained in clinical research led to a new paradigm for the~          treatment of patients affected with multiple sclerosis (MS): no evidence of disease~          activity. This means having each patient monitored with high quality imaging. To this~          purpose, researchers have developed segmentation algorithms for automated reading of~          MRIs, facilitating longitudinal comparisons, and allowing an accurate assessment of the~          number and the volume of focal lesions. We have thus a powerful strategic biomarker for~          the treatment of MS.~           Due to the relevance of comparing over time the evolution of lesions (lesion load) and~          brain atrophy, the French Society of Neuroradiology edited standardized national~          recommendations. The MS French Observatory (OFSEP) has adopted these recommendations, in~          order to harmonize exams for all patients all over the country. At an international~          level as well, MRI have been put at the heart of the therapeutic strategy.~           Therefore, we need now to create the conditions able to implement, collect and analyze~          imaging data according to these recommendations.~           This is the meaning of the MUSIC project, which aims to develop and assess a~          standardized monitoring MRI control tool for therapeutic decision.~           CADIMS is this tool. It is based on an integration of several segmentation algorithms~          developed by INRIA and an image viewer developed by b<>com and included in a regional~          images-sharing server ETIAM Nexus. This tool is a help showing segmented brain T2~          lesions, gadolinium-enhanced T1 lesions and news T2 lesions appeared from the previous~          MRI exam, in a multicenter clinical context.~        2. Objective To evaluate the accuracy of MS lesions detection on cerebral MRI by comparing~          the CADIMS tool to the expert consensus.~   "
27634|NCT03205267|"~     Bosutinib is a 2nd generation tyrosine kinase inhibitor that has shown promising results from~     first up to fourth line treatment in patients with in chronic phase of chronic myelogenous~     leukaemia. Most patients discontinuing the treatment with Bosutinib do so because of side~     effects occuring early after starting the treatment. A step in dosing scheme could improve~     these early toxicities. The aim of this study therefore is to demonstrate that temporary~     lowering of the Bosutinib dose during early treatment may help to reduce or prevent side~     effects while preserving efficacy.~   "
27635|NCT03205254|"~     The primary objective of this study is to generate preliminary data on the effects of a~     short-term diet of either fast food or Mediterranean type diet on HDL and microbiota~     composition and function in healthy subjects, which includes both normal weight and~     overweight/obese subjects.~   "
27653|NCT03205020|"~     The aim of the current study is to assess the accuracy of maternal serum amyloid A for~     prediction of preterm labor in women with threatened preterm labor.~   "
27654|NCT03205007|"~     Our overarching goal is to prove the benefit of a behavior change intervention designed to~     help older people overcome barriers associated with risk for inadequate nutrition, so that~     they can improve their nutritional intake of fruits and vegetables, low fat dairy, whole~     grains, nuts, lean meats, poultry and fish.~   "
27636|NCT03205241|"~     Research Plan~      Eleven trained cyclists have completed 4 cycling performance trials, before and after 4 weeks~     of fish oil supplementation and before and after 4 weeks of placebo with a 4 week washout~     between supplementation periods. During the performance trials blood, expired air and heart~     rate were collected. The blood samples have been used to investigate the production of~     inflammation resulting from the cycling performance test. Inflammation has been assessed~     using enzyme-linked immunosorbent assay for IL-6, which is an inflammatory cytokine. Work~     done from the cycling performance will be analysed to investigate whether there is a~     relationship with power and inflammation and whether this is modulated by fish oil~     supplementation.~      Specific Aims~        1. Does 4 weeks of Fish Oil supplementation attenuate the inflammatory response following~          high intensity cycling.~        2. Is a modulation of the inflammatory response connected to cycling performance.~      Hypotheses~        1. Four weeks of n3-PUFA supplementation will reduce the inflammatory response~        2. A reduction in inflammation will improve cycling performance~      Anticipated Outcomes~      A high level of cycling performance, indicated by a high average power, will be associated~     with high levels of systemic inflammation. n3-PUFA supplementation will decrease the level of~     inflammation and consequently cycling performance will be improved.~   "
27637|NCT03205228|"~     A randomized controlled trial study is conducted to compare treatment efficacy between~     psycho-education, anxiolytics drug and proton pump inhibitors in participants who met the~     criteria of globus.~   "
27638|NCT03205215|"~     We would like to see if Hyperbaric Oxygen can help improve the symptoms that result from Post~     Concussive Syndrome.~   "
27639|NCT03205202|"~     COSMOS-Eye is an ancillary study of the COcoa-Supplement and Multivitamins Outcomes Study~     (COSMOS) that will examine the role of a daily multivitamin and cocoa supplements in the~     prevention of cataract and AMD, two leading causes of visual impairment in US men and women.~   "
27640|NCT03205189|"~     This study evaluates the comparison of the incidence of postoperative home pain after~     ambulatory surgery with general anesthesia between a group with pre-surgical prescription~     delivered during anesthesia preoperative clinic and a group with postoperative prescription.~   "
27641|NCT03205176|"~     This is a first-time-in-man (FTIM) multicenter, dose escalation study designed to investigate~     the safety, pharmacokinetics, and pharmacodynamics of AZD5153 in patients with malignant~     solid tumors, including lymphomas.~   "
27642|NCT03205163|"~     The primary purpose is to assess the safety and tolerability of a single intravenous (IV)~     administration of BIVV001 in adult previously treated patients (PTPs) with severe hemophilia~     A.~   "
27643|NCT03205150|"~     The purpose of this study is to assess the effects of LIK066 on a variety of metabolic and~     inflammation biomarkers in patients with non-alcoholic steatohepatitis (NASH)~   "
27644|NCT03205137|"~     The primary objective of this study is to compare the medication adherence measured by PDC of~     patients with FDC or double-pill combination therapy in real-world Japanese therapeutic~     practice.The further objective of this study is how much influence the background of patients~     to the adherence.~   "
27645|NCT03205124|"~     Traumatic injury to the peripheral nerves is most common in the young population with high~     associated costs to the patient, as well as to society. These range from acute healthcare~     cost to loss of productivity and rehabilitation. Despite major efforts in improving surgical~     technique, functional outcome has not significantly improved in the past thirty years.~     Irreversible denervation, atrophy of target muscles, and deranged sensation secondary to slow~     or aberrant axonal outgrowth remains a significant challenge. Although pre-operative~     conditioning of the injured peripheral nerve with electrical stimulation has shown promise in~     animal studies, it has not been tested in humans.~      In animal studies, pre-operative conditioning with electrical stimulation (ES) of the injured~     peripheral nerves promoted peripheral nerve regeneration in both sensory and motor fibres. We~     propose to conduct a clinical trial comparing 3 different treatments of complete digital~     nerve laceration before and after surgical repair. Participants will be randomized to one of~     three treatment arms: i) pre and post operative electrical stimulation, ii) pre-operative~     electrical stimulation alone , or iii) control group that receives sham pre and~     post-operative electrical stimulation. We will evaluate the effect of pre-operative~     electrical stimulation on axonal regeneration, as well as determine whether there is an~     additive effect of pre and post-operative electrical stimulation on sensory nerve axonal~     regeneration.~   "
27646|NCT03205111|"~     The aim of this study is to photographically characterize the endometrium in patients~     presenting with abnormal uterine bleeding at age group from 20 to 45 years old.~      and compare dilatation and curettage with hysteroscopy in obtaining an accurate diagnosis of~     the etiology of abnormal uterine bleeding.~   "
27647|NCT03205098|"~     To assess the evolution of biological markers of mesenteric ischemia during ultratrail.~   "
27648|NCT03205085|"~     Right heart failure is the main cause of morbi-mortality in patients with pulmonary~     hypertension (PH), including patients of chronic thrombo-embolic pulmonary hypertension~     (CTEPH) or pulmonary arterial hypertension (PAH) etiologies. Endarterectomy is an effective~     treatment for patients with CTEPH to lower pulmonary pressure. Evidence of postoperative~     right heart remodeling are contrasted according to the studies and determinants of right~     heart failure are still unclear. Similarly, few evidence exists on right ventricular~     remodeling after bilateral lung transplantation for patients with pulmonary arterial~     hypertension (PAH). Recent evidence have supported the role of inflammation and immunity in~     the pathophysiology of PAH . While several cytokines have been shown to predict survival ,~     little is known on the implication of inflammation and immunity in postoperative Right~     Ventricular failure in patients with PAH.~      • The specific translational goal of this current project is to elucidate the role of immune~     biomarkers in 6 months postoperative right heart adverse remodeling in patients with CTEPH or~     PAH. We speculate that selected immune biomarkers (such as CXCL9, interleukin -18 or~     interferon) and growth factors (such as HGF) are correlated with mid-term postoperative right~     heart failure.~      All consecutive adults with either CTEPH referred to our center for endarterectomy, or PAH~     referred for lung transplantation, will be included, aiming for 150 CTEPH and 50 PAH. After~     inclusion, patients will undergo assessment of right heart dimensions and function by cardiac~     magnetic resonance imaging (MRI, including 4-Dimensions blood flow sequences) and 2D and 3D~     trans-thoracic echocardiography (TTE), as well as immune panel analysis. All patients will~     undergo as part of routine care right heart catheterization within a week after TTE and MRI~     imaging. On the day of surgery, pulmonary pressure will be measured by right heart~     catheterization monitoring (as part of routine care) in order to estimate the drop of~     pressure and to adjust for the extent of endarterectomy for patients with CTEPH. TTE will~     also be performed on the day of surgery if possible. At 7 days post-endarterectomy or~     transplant, clinical outcomes will be collected and peripheral blood will be collected.~     Patients will be prospectively follow-up for 6 months. Death, need for reintervention,~     duration of vasopressor after surgery and number, duration and cause of readmission will be~     recorded. At 6 months after surgery, all survivors will undergo the same biological sampling,~     as well as an 4D MRI and a 2D and 3D TTE. Data of right heart catheterization at 6 months (as~     part of routine care) will be collected as well.~   "
27649|NCT03205072|"~     A prospective, multi-center, non-randomized, observational, consecutive case series, which~     will compare Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) and cholangioscopy with Spy~     Glass Digital System (DS) procedure at 5-10 centers.~   "
27656|NCT03204981|"~     This study will examine the safety and efficacy of intramural needle ablation (INA) in the~     treatment of intramural ventricular arrhythmias in patients for whom standard RF ablation has~     been unsuccessful. The clinical team hypothesize that the increased current density and~     improved rates of transmural lesion creation seen with intramural needle ablation will lead~     to successful arrhythmia termination with minimal or no increased risk of complication.~   "
27657|NCT03204968|"~     Systemic inflammation is a potentially debilitating complication of thoracic surgeries that~     can result in significant physical and economic morbidity for afflicted patients. There is~     compelling evidence for the role of central nervous system in the regulation of systemic~     inflammatory responses through humoral mechanisms. Activation of afferent vagus nerve fibers~     by cytokines triggers anti-inflammatory responses. Direct electrical stimulation of the~     peripheral vagus nerve in vivo during lethal endotoxemia in rats inhibited Tumor necrosis~     factor (TNF) synthesis in liver preventing the development of shock. The vagal regulatory~     role of systemic inflammation after lung lobectomy is unknown.~   "
27658|NCT03204955|"~     This pilot study will compare the two hypertonic solutions currently used for subarachnoid~     hemorrhage (SAH) - related complications and to determine if the reduction of chloride load~     is safer, and as efficacious as the classic hypertonic solution.~   "
27659|NCT03204942|"~     AIM OF THE WORK To evaluate the effectiveness and safety of Pulsed and Thermal Radiofrequency~     lesion of the dorsal root ganglion (RF-DRG) on a consecutive group of patients presenting~     with chronic thoracic pain due to vertebral bone metastasis.~   "
27660|NCT03204929|"~     Multicenter, open-label dose-escalation study~   "
27661|NCT03204916|"~     This research trial studies cancer care delivery in adolescent and young adult patients with~     acute lymphoblastic leukemia. Surveying institutions, evaluating delivery of care at the~     patient level and seeking input from healthcare providers may help doctors increase rates of~     adherence to National Comprehensive Cancer Network (NCCN) treatment guidelines. It may also~     improve care for adolescent and young adult patients with acute lymphoblastic leukemia.~   "
27662|NCT03204903|"~     Subjects with dry eye are enrolled at two ophthalmic centers and randomly assigned to a laser~     acupuncture group and control group under conventional treatment with artificial tears. The~     effects of laser acupuncture therapy for patients with dry eye are investigated.~   "
27663|NCT03204890|"~     Background: Transcutaneous posterior tibial nerve stimulation is an effective therapy for~     controlling urinary incontinence. Premature ejaculation (PE) and urinary incontinence are~     anatomically and physio-pathologically similar. Based on this, the use of this therapy is~     considered to be viable for the control of PE.~      Objective: To evaluate the efficacy of transcutaneous posterior tibial nerve~     electrostimulation for the ejaculatory reflex.~      Patients and Methods: Phase II clinical trial. Patients with a diagnosis of premature~     ejaculation who are treated at the Colombia Boston Medical Group clinic will be included. The~     participants will receive 3 transcutaneous posterior tibial nerve stimulation therapies per~     week for 12 weeks. The IELT and the PEDT scale will be evaluated on week 6, at the end of~     treatment and three months after completing the protocol.~   "
27664|NCT03204877|"~     Modern living is associated with an epidemic of type 2 diabetes mellitus (T2DM). Sleep~     disturbances are strong independent risk factors for incident diabetes. Melatonin has been~     implicated in regulation of circadian rhythm and sleep, but it is also ascribed~     anti-oxidative properties and effects on glucose homeostasis. A potential association between~     melatonin and T2DM has only been addressed in few human physiological studies, but the topic~     has received renewed interest since genetic-epidemiological studies have pointed to a role~     for melatonin in the development of the disease. In the current study, the investigators wish~     to examine whether treatment with synthetic melatonin induces physiological changes that~     affect the risk of developing type 2 diabetes. Two studies of the physiological effects of~     melatonin are included in the present protocol. In study A, the investigators will examine~     the acute effects of Melatonin on insulin secretion and insulin sensitivity using a Botnia~     clamp and in study B the investigators will examine the potential effects of Melatonin on the~     incretin response.~   "
27665|NCT03204864|"~     This study is a prospective, multi-center, physician-initiated study, with intra-center~     control arm of patients with advanced heart failure undergoing cardiac resynchronization~     therapy (CRT) with or without defibrillator therapy.~      The purpose of this study is to verify whether optimizing the left ventricular lead position~     at implantation with the pacing cathode corresponding to the longest RV-to-LV electrical~     delay may result in a better patient outcome. The RV-to-LV electrical delay will be evaluated~     with RLD value (ms). RLD is the distance between the Right Ventricular pacing marker (VP) and~     the maximum peak (or the first maximum peak in case of two equally tall peaks) of the LV~     bipolar deflection.~   "
27666|NCT03204851|"~     The purpose of this pilot study is to assess the efficacy of Microlyte Ag wound dressing when~     used in complex skin wounds. Microlyte Ag is a class-II medical device cleared by the FDA for~     prescription and over the counter use in humans. Primary clinical end point of study is~     percentage change in wound size from initiation of Microlyte Ag treatment through 90 days or~     until wound closure. Patient population comprises patients referred to Mission's Wound~     Healing and Hyperbaric Center for management of their wounds. Targeted enrollment is 100~     subjects distributed into 4 study cohorts corresponding to the type of wound treated: venous~     stasis ulcer (20 patients); diabetic foot ulcer [DFU] (20 patients); pressure ulcer (20~     patients); wounds of various other etiologies (40 patients).~   "
27677|NCT03204708|"~     patients undergoing modified radical mastectomy were divided into two groups. patients in~     catheter group were placed a catheter with open technique by the surgeon in the pectoral~     area. thirty minutes before extubation %1 lidocain 10 ml, %0.5 bupivacain 10 ml and 10 ml~     %0.9 sodium chloride were given through the catheter for postoperative analgesia. patients in~     iv analgesia group were given 100 mg tramadol iv 30 minutes before extubation. visual analog~     pain scale (VAS) scores, rescue analgesic requirement, complications were recorded and~     compared between two groups 1, 6, 12, 24 hours and 90 days after surgery.~   "
27678|NCT03204695|"~     The WAVECREST PMCF Study is a prospective, non-randomized, multicenter study to confirm~     safety and performance of the Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System~     in the current medical practice setting in patients with non-valvular atrial fibrillation who~     are at increased risk for stroke. Up to 65 subjects may be enrolled at up to 15 study sites~     in Europe. Patients will be followed through 45 days post-procedure.~   "
27667|NCT03204838|"~     This leukemia is characterized by a poor prognosis for most patients, as they have a high~     relapse rate despite aggressive treatment with chemotherapy agents and allogeneic bone marrow~     transplantation. It has been proposed that relapse can be attributed to a leukemic cells~     population with quiescence properties that are resistant to chemotherapy, known as leukemic~     stem cells (LSCs). Clinical trials shown a major LSCs percentage than diagnosis correlated~     with worst prognosis or minimal residual disease with AML.~      AML is most common in adults and represents about 40% of all leukemia types in American~     Continent. In Mexican patients with AML age median is 32 years, lower than other~     international series. Genomic and functional studies have identified two classes of~     mutations, which cooperate during AML development.~      Somatic mutations have been identified recently that codify for isocitrate dehydrogenase~     (IDH). These genes codify key metabolic enzymes, which convert isocitrate into~     α-ketoglutarate (α-KG).15-16From which IDH1 and IDH2 genes presenta high frequency of~     mutations in AML and other types of tumors. IDH mutations affect mainly active site residues~     (for example, IDH1 R132, IDH2 R140 or IDH2 R172), resulting in the normal enzymatic function~     loss abnormally converting α-KG to 2-hydroxiglutarate (2-HG).~      Oncometabolyte 2-HG may competitively inhibit multiple α-KG depending dioxygenases,~     including key epigenetic regulators as histones demethylases and TET proteins. Consequently,~     IDH mutations are associated with chromatin alterations including global alteration of~     histones and NDA methylation. This is the reason of the need to identify such mutations of~     genes (IDH1/IDH2) in patients with SMD and AML entering Hematology service of the Hospital~     General de Mexico from 2017 to 2019, and determine clinical impact in prognosis and~     monitoring the response to therapy, as well as prognosis and survival.~   "
27668|NCT03204825|"~     Peripheral Arterial disease is a common condition which causes narrowing of the arteries. The~     most common symptom that patients with PAD experience is Intermittent Claudication (IC), pain~     in the lower limb(s) on exertion, which is relieved by rest. IC reduces patients' quality of~     life (QoL) by limiting their ability to walk and engage in daily activities. Regular exercise~     and physical activity (PA) are central to the management of PAD and help to improve walking~     distances and reduce the risks associated with PAD such as heart attack and stroke. However,~     exercise and PA in this population is often limited due to pain. Investigators have shown~     that Transcutaneous Electrical Nerve Stimulation (TENS) can help to reduce pain and increase~     walking distance in patients with PAD. Investigators have also shown that educating patients~     about their condition and helping them to set goals has the potential to increase PA, and~     quality of life. This study will examine the feasibility of designing a definitive trial that~     investigates whether TENS can improve the physical activity of patients with PAD when~     delivered alone and/or alongside a patient education programme.~   "
27669|NCT03204812|"~     The goal of this clinical research study is to study the safety and tolerability of~     durvalumab and tremelimumab when given to patients with metastatic (has spread)~     castration-resistant prostate cancer.~      This is an investigational study. Tremelimumab and durvalumab are not FDA approved or~     commercially available. They are currently being used for research purposes only. The study~     doctor can explain how the study drugs are designed to work in more detail.~      Up to 27 participants will be enrolled in this study. All will take part at MD Anderson.~   "
27670|NCT03204799|"~     Microbiota is important for immunology, hormonal and metabolic homeostasis in human and could~     influence on developing diabetes and obesity. Recent studies investigates microbiota by~     metagenomic sequencing, however, the composite of microbiota and its metabolic role has not~     been fully determined. Metagenomics and microbiome analysis could early diagnose metabolic~     disorders and suggest treatment options for metabolic diseases.~      In this study, the investigators investigate the composite of microbiota and deduct basic~     information for treatment models using metagenomic sequencing.~   "
27671|NCT03204786|"~     This purposed of this clinical trial is to investigate the effectiveness of vasopressin nasal~     spray for treating symptoms associated with autism. Vasopressin is a hormone that is produced~     naturally within the body and has been implicated in regulating social behaviors. It has been~     proposed that administration of the hormone may also help improve social functioning in~     individuals with autism.~   "
27672|NCT03204773|"~     Comparing the non-motor symptoms of patients with SPG4 mutations to healthy controls~     (spouses, relatives or other healthy controls) by using the a number of specific~     questionaires~   "
27673|NCT03204760|"~     The aim of this study is to compare the efficacy of a single dose of intramuscular~     dexamethasone versus 3 days of twice-daily oral prednisolone in the management of mild to~     moderate asthma exacerbations in children and test whether this single dose of intramuscular~     dexamethasone 0.6 mg/kg (max. 18 mg) is equal to prednisolone 1 mg/kg/day (max. 40 mg) in the~     treatment of exacerbations of asthma in children, as measured by the Pediatric Respiratory~     Assessment Measure (PRAM).~   "
27674|NCT03204747|"~     Multiple sclerosis causes demyelinating lesions, which can induce multiple symptoms. If motor~     disorders are the most visible disability, urinary disorders are frequent, with prevalence~     from 32 to 86%. The first ones are due to pyramidal, cerebellar or proprioceptive lesions.~     The seconds are due to specific lesion in inhibitor/activator encephalic centers, or~     interruption on medullary conduction. It seems to be evident that walk and urinary disorders~     are link, because of similar anatomic ways and control process. Effect of bladder filling is~     well known on motoneuronal excitability. The effect of bladder filling on walk stay unknown,~     while medullary integration of these two functions is very close, in medullary cone.~      Primary aim is to assess the effect of need to void on walk speed in multiple sclerosis with~     lower urinary tract symptoms. Secondary aim is to identify clinical or urodynamic factor link~     with major walk impairment when patients need to void.~      Patient with multiple sclerosis over 18 years old, consulting for lower urinary tract~     symptoms in a tertiary center are included.~      History and treatment, high, weigh, symptoms severity by USP score, cognitive impairment by~     MMSE score and last urodynamic data are recorded. Patient are asked to drink water until they~     feel a strong need to void, for which they would go to urinate at home.~      Walk tests are realized in a specific place, with calm and no passage. A chair is placed at~     each end of the path. Toilets are just next to the hall where they realize the tests. A 10~     Meters Walk Test is done during this condition, 3 times (only the intermediate 6 meters are~     recorded). They can take 30 seconds of rest between each try if necessary. One Timed up and~     go is done. Patient can use their habitual walking device. Speed walk asking is comfortable~     for the two test.~      Next, patient can urinate. 3 post void residual volume with portable echography are done, and~     the higher is recorded.~      Patient achieve the same walk tests after urinate, in the same order. They must use the same~     walking device.~      Primary outcome is mean gait recorded for 10 meters walk test.~      Secondary outcome is time for timed up and go test.~      Individual variability between the 3 10MWT in the two conditions will be study.~      Influence of age, EDSS, severity of symptoms, MMSE, detrusor overactivity on speed impairment~     will be study in secondary analysis.~   "
27675|NCT03204734|"~     A single-site study about the efficacy of sequential monotherapy: Capecitabine vs. endocrine~     therapy, in metastatic breast cancer patients with HR-positive & HER2-negative after~     capecitabine-base chemotherapy.~   "
27676|NCT03204721|"~     The main aim is to test the preventive use of extracorporeal photophoresis (ECP) against~     development of graft-versus-host disease (GVHD) in patients undergoing allogeneic stem cell~     transplantation for hematological malignancy.~   "
28606|NCT03192566|"~     Although there are numerous studies investigating the pharmacokinetic properties of~     intravenous acetaminophen in infants and children with normal weight, there are none in the~     obese pediatric patient . This study will investigate the pharmacokinetics and~     pharmacodynamics of acetaminophen (total Cl and Vd) in obese children and adolescents~   "
27679|NCT03204682|"~     Endometriosis is associated with different types of pain (acute, chronic, excess nociception,~     neuropathic) generated by different mechanisms in the nervous system. The rTMS could provide~     significant analgesia for refractory endometriosis pain.~      The aim of the study is to evaluate the feasibility of transcranial magnetic stimulation~     (rTMS) for analgesia on chronic refractory endometriosis pain.~   "
27680|NCT03204669|"~     Major burn patients are characterized by large exudative losses of Cu, Se and Zn. Trace~     element (TE) repletion has been shown to improve clinical outcome. The study aimed to check~     if our repletion protocols were achieving normalization of TE plasma concentrations of major~     burn patients and if the necessity for continuous renal replacement therapy (CRRT) might~     increase the needs.~   "
27681|NCT03204656|"~     Difficult orotracheal intubation carries a risk of hemodynamic collapse, neurological~     sequelae secondary to cerebral anoxia or death. Anesthetic scores and predictive indices are~     used to predict difficulties and avoid complications for usual tracheal intubation. However,~     existing indices are not adapted to selective bronchial intubations.~      The aim of the study is to determine the incidence of unexpected difficult SBI using~     conventional screening tests. It is a prospective descriptive epidemiological monocentric~     study comparing two groups of patients (selective vs. non selective intubations).~   "
27682|NCT03204643|"~     Patients who present to one of the participating EDs with a telepsychiatric consult performed~     will be treated and followed per the behavioral health virtual patient navigation pathway~     (BH-VPN) or usual care. The BH-VPN is inclusive of several components which will all be~     consistently applied to patients randomized to the intervention, as well as having access to~     behavioral health trained patient navigators. These key components are often deployed~     inconsistently as a part of usual care, but per the intervention, will be completed in~     totality for subjects who are assigned to and participate in the BH-VPN plan.~      This study includes a qualitative sub-study to measure perceptions of the impact of the~     BH-VPN on readmission rates and patient outcomes, experiences with the services provided by~     the BH-VPN, and provider and clinician ideas for how to improve the services provided by the~     BH-VPN.~   "
27683|NCT03204630|"~     A randomized double blinded controlled study including infants at the age of 1 month .~     Infants are assigned randomly to either infant formula supplemented with B. breve CECT7263 or~     L.fermentum CECT5716 (Probiotic groups), or the same formula without the probiotic strain~     (Control group). The primary outcome of the study is the body weight gain of infants.~     Secondary outcomes are incidence of infections, symptoms related with intestinal function,~     and fecal microbiota~   "
27684|NCT03204617|"~     The AELIX-002 study aims to evaluate the safety and the immunogenicity of DNA.HTI~     administered alone and as part of an heterologous prime-boost regimen in combination with~     MVA.HTI in early diagnosed and treated HIV-1 positive individuals, males and females,18-60~     years of age.~   "
27685|NCT03204604|"~     The Brain Ketone Body Challenge Imaging Study will measure how the brain uses different~     fuels. To do this, radioactive compounds will be used during Positron Emission Tomography~     (PET) imaging.~      These compounds, called [11C]Acetoacetate (AcAc) and [18F] Fludeoxyglucose (FDG), are similar~     to the sugars and fats the brain already uses for fuel. These compounds safely allow~     researchers to see how the brain uses sugars and fats during PET scans.~   "
27686|NCT03204591|"~     Acute hepatic insults including hepatitis flare-up, active alcohol assumption and hepatotoxic~     drug use are common in patients with cirrhosis especially in Eastern countries.These patients~     are at high risk of developing acute-on-chronic liver failure (ACLF) and associated with high~     short-term mortality. And the natural history of these patients is frequently complicated by~     bacterial infections, which lead to deterioration of underlying diseases. The present study~     is aimed to investigate the prevalance and risk factors of bacterial infections in those~     patients and its impact on in-hospital/short-term mortality.~   "
27687|NCT03204578|"~     Investigator-initiated physiological study to characterize the function of a major drug~     metabolizing enzyme using a microdosed phenotyping probe to avoid unwanted,~     concentration-dependent effects.~   "
27688|NCT03204565|"~     The purpose of this randomized controlled clinical trial (RCT) is to determine the efficacy~     hyaluronic acid (HA) in combination with the coronally advanced flap (CAF) for the treatment~     of single gingival recession site.~      The hypothesis is that HA will result in improved the clinical outcomes and will reduce the~     pos-operative morbidity~   "
27689|NCT03204552|"~     To determine the effect of diet and lifestyle, particularly vegetarian diets on chronic~     degenerative disease outcomes in a cohort of Taiwanese Buddhists participants~   "
27690|NCT03204539|"~     The primary goal of the INITIATE trial is to compare the clinical outcome of individualized~     lot selection to random lot selection utilizing one plasma-derived von Willebrand factor~     (VWF)/coagulation factor (FVIII) complex concentrate for immune tolerance induction (ITI) in~     subjects with congenital Hemophilia A, FVIII activity ≤2%, and a historical high-titer~     inhibitor [≥5 Bethesda Unit (BU)].~   "
27691|NCT03204526|"~     Prospective trial of low frequency deep brain stimulation of the ventral subthalamic nucleus~     to improve cognitive performance in patients with advanced Parkinson's disease. All study~     participants have undergone DBS implantation surgery as part of their routine care for motor~     manifestations of Parkinson's disease. In this study, a temporary low frequency period of~     stimulation will be applied to determine its effects on cognition.~   "
27692|NCT03204513|"~     The overall goal of this research is to determine the efficacy of new powered prosthetic~     devices for individuals with transfemoral amputations. The anticipation is that this will be~     a high-impact technological intervention with the potential to restore significant~     functionality to individuals with lower limb amputation and transform the field of lower limb~     prosthetics. The objective of the proposed clinical trial is to fully evaluate the~     biomechanical and energetic effects of using PKA prosthesis and quantify functional~     performance and quality of life changes.~   "
27693|NCT03204500|"~     This is a pilot study in 40 subjects with definite ALS to evaluate the efficacy of valproate~     and lithium carbonate. After a random assignation of the dual treatment vs. placebo, a~     follow-up of 20 months will allow to know the clinical and functional evolution so as the~     status of biomarkers under each treatment.~   "
31249|NCT03158038|"~     This prospective annual release study is designed to evaluate the safety of 1 new influenza~     virus vaccine strain to be included in FluMist Quadrivalent for the 2017-2018 influenza~     season.~   "
27694|NCT03204487|"~     Studies have shown that ocular surface disease (OSD) is common among patients with glaucoma~     with a prevalence of 50% or more. The percentage of affected patients appears to increase~     with increasing number of topical anti-glaucoma products instilled. Both pre-clinical and~     clinical work has indicated that the preservatives used in anti-glaucoma drops, particularly~     benzalkonium chloride, are mainly responsible for this detrimental effect. As such more and~     more anti-glaucoma drugs without preservatives entered the market.~      To prove that switching from preserved to unpreserved antiglaucoma medication improves the~     signs and symptom of OSD is, however, not easy. This is on the one hand related to the~     physiological variability of these parameters over time and on the other hand to the poor~     association between signs and symptoms. Recently, a new method for measuring tear film~     thickness (TFT) using ultra-high resolution optical coherence tomography (OCT) has been~     introduced. Using this method, it has been shown that there is a correlation between reduced~     TFT and OSD symptoms. In the present study, it is hypothesized that changing patients who are~     on preserved prostaglandin formulations to preservative free tafluprost may be associated~     with an increase in TFT.~   "
27695|NCT03204474|"~     The purpose of this study is to assess the bioequivalence of a 200 mg single dose Lacosamide~     (LCM) intravenous (iv) solution with a 200 mg single dose LCM oral tablet in healthy Chinese~     male subjects.~   "
27696|NCT03204461|"~     In the present study glucose metabolism and ectopic lipids in the liver, heart and muscle~     were investigated in women with the polycystic ovary syndrome (PCOS) and in healthy control~     subjects.~   "
27697|NCT03204448|"~     The study is to evaluate the clinical performance of BioCLIA Ro60 for measuring the~     autoantibody in autoimmune disease patients.~   "
27698|NCT03204435|"~     To evaluate the clinical benefits and risks of hybrid operating techniques in management of~     intracranial aneurysms with coexistence of atherosclerotic intracranial arterial stenosis.~   "
27699|NCT03204422|"~     The accurate evaluation of daily salt or sodium intake is difficult to implement in clinical~     practice and large epidemiological studies. 24-h urinary sodium excretion (USE) is considered~     the gold standard, but is expensive and has a high participant burden. To further explore the~     association between 24-h USE and spot urines in Chinese population, it was proposed that~     using collected multiple spot urine samples could be estimated for 24-h USE in Chinese~     children and adults.~   "
27700|NCT03204409|"~     Study to enroll up to 1000 adult patients (>18 years) presenting with febrile or rash illness~     of short duration (<72h) in designated clinics in the State of Sao Paulo, Brazil.~   "
27701|NCT03204396|"~     Cigarette smoking is the leading preventable cause of premature death worldwide. However~     smoking is a very difficult addiction to break whereby main reasons for not quitting or~     relapsing after cessation are the nicotine withdrawal syndrome and post-cessational weight~     gain. GLP-1 analogues are well known to stimulate insulin secretion and to reduce energy~     intake and therefore body weight. Recent findings from animal and human studies suggest a~     role of GLP-1 in the pathophysiology of addiction. The putative role of GLP-1 analogues in~     nicotine reward regulation combined with its weight reducing effects might be of major~     interest in view of novel pharmacotherapeutic options for smoking cessation.~   "
27702|NCT03204370|"~     Mucopolysaccharidosis IVA (MPS IVA) (or Morquio A disease) is a rare recessive autosomal~     lysosomal storage disorder caused by deficiency of N-acetylgalactosamine-6-sulfatase (GALNS)~     resulting in accumulation of the glycosaminoglycans (GAGs) chondroitin-6-sulfate and keratin~     sulfate (KS). Patients display progressive development of skeletal and joint abnormalities~     and non-skeletal features including respiratory, cardiac, sensorial and neurological~     complications. Recently, a specific treatment using enzyme replacement therapy (ERT) with~     recombinant human GALNS (elosulfase alfa) has become available. A multicenter double-blind~     placebo-controlled phase 3 trial (176 patients, age > 5 yrs) showed significant improvement~     in endurance of 22.5 m in 6 Minute Walking Test (6MWT) distance after 24 weeks of treatment~     with elosulfase alfa at 2.0 mg/kg/week as compared with placebo group. In addition to ERT, a~     multidisciplinary management approach is necessary for coordinating assessment and follow-up~     as well as for providing individualized supportive and symptomatic care.~      The clinical presentation is highly variable from one patient to another regarding age at~     onset, severity, progression rate and life expectancy. Most patients are affected with the~     classical phenotype characterized by short trunk dwarfism with short neck and adult height <~     1 m. Atypical phenotypes with less severe extension of skeletal manifestations, adult height~     > 1m, and less frequent complications in other organs have been progressively recognized.~     Clinical management differs depending on the clinical presentation of the patients but~     natural history of the disease is largely unknown in atypical phenotypes. Precise and~     exhaustive follow-up data are needed in such patients to increase our knowledge of this~     natural history and to define the best criteria to evaluate ERT efficiency.~      The investigators propose a prospective clinical study focused on a unique large series of 9~     adult patients (aged from 18 to 55 years) followed in a single expert center for metabolic~     disorders located at the university hospital of Bordeaux, France. Eight of these patients are~     affected with atypical MPS IVA characterized by less severe evolution of the disease and~     heights ranging from 135 to 176 cm (the last patient height is 102 cm). Investigators aim to~     increase knowledge on the natural history of the disease in adult patients with atypical MPS~     IVA, treated or not with ERT, and to develop new objective and robust clinical criteria to~     evaluate the efficiency of ERT over time, particularly in patients presenting an atypical~     phenotype. The entire cohort treated or not treated with ERT, will be evaluated at baseline~     and every year during a 5-years period. The complete evaluation at baseline will be our~     absolute priority as well as obtaining long-term and exhaustive follow up of the patients~     treated with ERT (two patients of the cohort already treated, and ERT expected in three~     additional patients in the next months).~      The investigators designed a schedule of systematic and exhaustive assessments based on the~     recommended follow up from experts panel consensus meeting (MorCAP protocol) extended to some~     additional investigations including motor, cardiac and rheumatologic exams as our specific~     focus.~   "
27703|NCT03204357|"~     Autologous blood transfused at the end of cardiopulmonary bypass will reduce total blood loss~     24 hours after surgery and improve mitochondrial oxygen delivery measured by plasma succinate~     levels.~      The study design is a prospective randomized interventional trial of transfusion of fresh~     autologous whole blood versus standard of care expectant management of bleeding during~     elective cardiac surgery.~   "
27704|NCT03204344|"~     For non-diabetic patients undergoing gastrointestinal surgery, preoperative oral carbohydrate~     improves postoperative recovery. The purpose of this pilot study is to investigate the impact~     of preoperative oral carbohydrate (outfast®) on the recovery in diabetic patients after~     gastrointestinal surgery.~   "
27705|NCT03204331|"~     The purpose of this study is to determine the benefit and safety of relugolix 40 mg once~     daily, co-administered with low-dose estradiol and norethindrone acetate compared with~     placebo for 24 weeks, on dysmenorrhea and on nonmenstrual pelvic pain.~   "
27706|NCT03204318|"~     The purpose of this study is to determine the benefit and safety of relugolix 40 mg once~     daily, co-administered with low-dose estradiol and norethindrone acetate compared with~     placebo for 24 weeks, on dysmenorrhea and on nonmenstrual pelvic pain.~   "
27707|NCT03204305|"~     All participants will be healthy volunteers and all procedures will be completed for research~     purposes only. Two groups will be recruited, females who use cannabis (marijuana, MJ), and~     female who do not use cannabis (controls). Female MJ users will be enrolled in a protocol~     that includes an outpatient drug administration session and a 4-day/3-night inpatient stay on~     the Johns Hopkins Bayview Clinical Research Unit (CRU). During outpatient visits, MJ users~     will have an MRI, and complete MJ self-administration and cognitive performance sessions. MJ~     users will then reside on the CRU,and complete MJ abstinence, and self-report instruments for~     withdrawal discomfort. A positron emission tomography (PET) scan of brain cannabinoid type 1~     receptors will also be completed. Non-users will complete MRI, PET imaging and cognitive~     testing under an outpatient protocol (no MJ administration).~   "
27708|NCT03204292|"~     ratio of the diameter of inferior vena cava to the diameter of the thoracic aorta (IVC / Ao)~     depends on the daily balance of fluids.~   "
27725|NCT03204071|"~     Metformin (MF), a biguanide group of anti-diabetic drug has been shown to enhance osteoblasts~     differentiation and inhibit osteoclast differentiation in vitro, thus may exhibit a favorable~     effect on alveolar bone.~      AloeVera Gel had also been used in dentistry and showed good results.The present study aims~     to explore the efficacy of 1% MF gel and aloe vera gel as a local drug delivery system in~     adjunct to scaling and root planing (SRP) for the treatment of subjects with chronic~     periodontitis (CP) with intrabody defects.~   "
27791|NCT03203213|"~     Poisoning by psychoactive substances is increasingly common in Europe and can be responsible~     for deaths. These substances, also called festive drugs, circulate among other places in~     festive gatherings (night clubs, concerts, free music, feria, etc.). The main objective of~     this study is to determine the molecules that circulate in festive events in Aquitaine, in~     order to implement prevention actions by looking at whether the circulating substances vary~     with the style of event.~   "
27709|NCT03204279|"~     This study is Phase 2 pharmacokinetic (PK) and pharmacodynamic (PD) dose-finding study of~     oral netupitant administered concomitantly with oral palonosetron in pediatric cancer~     patients for the prevention of nausea and vomiting associated with emetogenic chemotherapy.~     Two different netupitant dosages will be tested in patients aged from 3 months to < 18 years:~     1.33 mg/kg up to a maximum of 100 mg, and 4 mg/kg up to a maximum of 300 mg. All netupitant~     doses in all age classes will be concomitantly administered with palonosetron 20 μg/kg (up to~     a maximum dose of 1.5 mg) which is the IV palonosetron dose approved by USA FDA for the~     pediatric population. The primary objective is to investigate the PK/PD relationship between~     netupitant exposure (AUC, Cmax) and antiemetic efficacy (CR in delayed phase) after a single~     oral netupitant administration, concomitantly with oral palonosetron in pediatric cancer~     patients receiving Moderately Emetogenic Chemotherapy (MEC) or Highly Emetogenic Chemotherapy~     (HEC) cycles. Efficacy parameter to be used in the correlation is the proportion of patients~     with Complete Response (CR i.e., no emetic episodes and no rescue medication) during (>~     24-120 h after the start of chemotherapy on Day 1).~      The secondary objectives are to assess the safety and tolerability after single oral~     administration of netupitant given concomitantly with a single oral administration of~     palonosetron; to evaluate the pharmacokinetic (AUC, Cmax, tmax and t1/2) of oral palonosetron~     at the fixed dose of 20 μg/kg in pediatric patients with the concomitant administration of~     netupitant. A total of 92 pediatric cancer patients receiving either HEC or MEC will be~     enrolled in the study.~   "
27710|NCT03204266|"~     The goal of this clinical research study is to learn the supplements Pro-Stat (which has~     l-arginine and also contains protein) and omega-3 fatty acids will be well tolerated in~     patients who have radical cystectomy for bladder cancer. Researchers also want to learn how~     these medications affect inflammation and recovery for these surgical patients.~      This is an investigational study. Pro-Stat is not FDA-approved to treat any specific~     condition or disease. Omega-3 fatty acids are FDA-approved to treat high triglyceride levels.~     Their use to treat inflammation and help improve recovery after bladder cancer surgery is~     investigational.~      The study doctor can explain how the supplements are designed to work.~      Up to 46 participants will be enrolled in this study. All will take part at MD Anderson.~   "
27711|NCT03204253|"~     Pregnancy rates fall dramatically in women after 35 years undergoing to IVF or ICSI. While~     ovarian aging obviously plays the major role in this phenomenon, over suppression of~     endogenous LH concentrations with GnRH agonists or antagonists—an integral part of standard~     IVF/ ICSI protocols—may also play a pivotal role.~      Assisted reproduction technology protocols using GnRH agonists have been considered as the~     standard protocol during the last two decades, but the use of GnRH antagonists offers the~     opportunity to control the endogenous LH surge in a rapid and more convenient way.~      LH plays a key role in the intermediate-late phases of folliculogenesis. The presence of~     receptors for LH in cumulus granulosa cells and its correlation with oocyte maturation has~     been demonstrated. Although ovarian stimulation is efficiently achieved in most cases by the~     administration of exogenous FSH alone, specific subgroups of women may benefit from LH~     activity supplementation during ovarian stimulation. Some authors have found improved outcome~     with LH activity supplementation in advanced reproductive age women.~      LH has a number of roles in follicular development, induction of ovulation, completion of~     meiosis I, early luteinization and the production of progesterone.~      The efficacy of recombinant human follicle-stimulating hormone (r-hFSH) for ovarian~     stimulation is well established however, the role of supplementary recombinant human~     luteinizing hormone (r-hLH) is less clear.~      Aim of the present study is to evaluate If adding rLH in the late phase of stimulation can~     benefit in some patient awith repeated implantation failure.~   "
27712|NCT03204240|"~     Individuals with spinal cord injury (SCI) live longer than before and live to an age where~     metabolic disorders become highly prevalent. Due to loss of mobility and severe skeletal~     muscle atrophy, obesity, glucose intolerance, and peripheral insulin resistance develop soon~     after the onset of SCI. These abnormalities are thought to contribute to the increased~     diabetes disease risk and accelerated aging process in the SCI population. As a result of~     these trends, overall burden of complications, economic impact and reduced quality of life~     are increasing. Until there are effective treatments for SCI, it is imperative to develop~     effective interventions to mitigate metabolic disorders that develop in individuals with SCI.~     The proposed research project examines the impact of early utilization of a novel~     neuromuscular electrical stimulation (NMES) program on skeletal muscle metabolism and overall~     metabolic health in individuals with sub-acute, complete SCI.~   "
27713|NCT03204227|"~     A study of the study vaccine (JECEVAX- VABIOTECH-Vietnam) and a licensed vaccine~     (JEVAX-VABIOTECH-Vietnam) is conducted in Vietnamese children, aged 9 to 24 months to assess~     the safety of the study vaccine compares to licenced vaccine. Two hundred and twenty children~     are enrolled and randomly assigned into 2 groups (110 children/group), each of which receive~     2 doses of study / control vaccine subcutaneously, at 28-34 days interval. Safety data~     included immediate reaction at the injection site and systemic reaction within 30 min of~     administration, solicited and unsolicited adverse events occurs from the 1st dose to 28-34~     days after first dose and from the second dose to 28-34 days after 2nd dose. SAE (from start~     of first dose to 28-34 days after second dose).~   "
27714|NCT03204214|"~     Case Control Study :~      Objective:~      Frequent Binge drinking during 18-25 years is a risk factor of alcohol addiction in adulthood~     (25-40 years) Hypothesis: 25% of frequent binge drinking, OR = 2, power 80%, alpha risk : 5%~     126 Cases aged 25 to 40 years: alcohol addict patients recruited in Addiction Unit in Rouen~     University Hospital 126 controls aged 25 to 40 years: non alcohol addict recruited by the~     Clinical investigation center in Rouen University Hospital An anonymous self-questionnaire~     was completed Binge Drinking during 18-25 years was retrospectively evaluated Confusion biais~     was also recorded~   "
27715|NCT03204201|"~     This is an open-label feasibility study utilising direct instillation of ICG into the urethra~     during surgery for low rectal cancers. The trial involves a single intervention taking place~     during the patient's operation. Participants will be included in the study for around 2~     months with time either side of the intervention to collect background data.~   "
27792|NCT03203200|"~     This study develops and tests a behavioural and structural intervention to prevent~     unprotected sex among young female sex workers. Half the participants will receive the~     intervention and half will receive the standard of care.~   "
27716|NCT03204188|"~     Background:~      Chronic lymphocytic leukemia (CLL) is a cancer of white blood cells. It is also called small~     lymphocytic lymphoma (SLL). It causes tiredness, night sweats, weight loss, swollen lymph~     nodes, easy bruising or bleeding, and frequent infections. Researchers want to test if a drug~     combination is effective and safe for people with CLL/SLL.~      Objective:~      To test how safe and effective a combination of ibrutinib, short-course fludarabine, and~     pembrolizumab is for people with chronic lymphocytic leukemia (CLL), also known as small~     lymphocytic lymphoma (SLL).~      Eligibility:~      Adults at least 18 years old who have CLL or SLL, with certain genetic changes.~      Design:~      Participants will be screened with:~        -  Medical history~        -  Physical exam~        -  Heart tests~        -  Blood and lab tests~        -  Small lymph node sample removed by needle~        -  Sample of bone marrow taken by needle in the hipbone. The area will be numbed.~        -  CT or PET scan. They will lie in a machine that takes pictures. They may have a~          radioactive sugar injected before the scan.~        -  Pregnancy test~      Phase 1 will be 12 weeks. Participants will take ibrutinib by mouth once a day. For weeks 5~     and 9 they will also take fludarabine. It will be infused in a vein for half an hour each day~     for 5 days in a row.~      Phase 2 will be 2 years. Participants will take ibrutinib by mouth once a day. They will also~     get pembrolizumab by vein for half an hour once every 3 weeks.~      After that, the study team will decide if participants should continue therapy.~      During the study, participants will have regular visits. They will repeat some or all~     screening tests.~   "
27717|NCT03204175|"~     This study will assess the impact of a school-based water, sanitation, and hygiene management~     intervention on toilet use and pupil handwashing in the Philippines.~   "
27718|NCT03204162|"~     There is significant data showing that the quality of CPR performed is quite poor. Recent~     studies have shown that when real-time visual corrective feedback is available to CPR~     providers, quality (compression depth and rate) improves.~      Pilot work at John's Hopkins Children's Hospital indicates that providing a CPR Coach whose~     role it is to provide real-time coaching during cardiac arrest, further improves the quality~     of CPR. This study will assess the impact of a CPR Coach for improving CPR quality and CPR~     perception in a team of healthcare providers during simulated CPA.~   "
27719|NCT03204149|"~     This is a randomized, double blind, placebo-controlled study to evaluate the safety of the~     low level laser MC-8XL device treatment in subjects with an unsuccessfully treated Diabetic~     Foot Ulcer (DFU) that has been present for at least 3 months.~      Eligible subjects will be randomized to either Treatment group or Control group, following~     which, treatment of each subject will be provided by a qualified nurse at the clinic or in~     the home setting, everyday for up to 16 weeks.~      Study assessments and adverse events monitoring will be also performed throughout the study.~   "
27720|NCT03204136|"~     Mesalazine, steroid, immunosuppressants and biologic agents are main medical treatments in~     treating inflammatory bowel diseases. Yet some patients develop severe side effects or~     initial invalid to conventional therapies. Some studies have already showed that tarcolimus~     and methotrexate are both effective in inducing and maintaining disease remission. Here we~     conduct a retrospective study to compare the efficancy of tarcolimus and methotrexate in~     treating refractory inflammatory bowel diseases as rescue therapy.~   "
27721|NCT03204123|"~     The purpose of this study is to see if a new diagnostic research agent named~     68Ga-HBED-CC-PSMA can show prostate cancer on a PET/CT scan that cannot be seen on other~     standard imaging even when the PSA levels are very low.~   "
27722|NCT03204110|"~     Reversible cerebral vasoconstriction syndrome (RCVS) is a clinico radiological entity~     characterized by severe headaches (associated or not with neurological complications) during~     one to 3 weeks, associated with a characteristic 'string and beads' appearance on cerebral~     arteries, which resolves spontaneously in 3 months. The pathway is unknown. At early stage of~     the disease (at the first medical consultation) cerebral arterial abnormalities which are~     necessary for diagnosis are identified in only 20% of patients (brain magnetic resonance~     imagery (MRI) ,CT scan angiography), appearing with a delay on 2th or 3rd week after the~     first severe headache..~      Retinal artery network is considered to be a window on brain microvasculature by sharing the~     same embryologic origin and physiopathology. A retinal arteriolar examination at early stage~     of RCVS could provide non invasively early clue to confirm diagnosis by identifying~     anatomical change and /or functional abnormalities at the microvascular level, whereas large~     cerebral artery abnormalities are still normal.~   "
27723|NCT03204097|"~     Alendronate (ALN), commonly use bisphosphonates is proposed to have osteostimulative~     properties in vivo and in vitro, as shown by an increase in the matrix formation, and acts as~     a potent inhibitor of bone resorption. AV widely known for its wound healing, analgesic,~     antioxidant, antibacterial, antiviral, antifungal, immune boosting and significant~     anti-inflammatory properties. The present study aims to explore the efficacy of 1% ALN and AV~     gel as a local drug delivery as an adjunct to scaling and root planing (SRP) for the~     treatment of degree II furcation defects~   "
27724|NCT03204084|"~     Pterygium is a wing-shaped fibrovascular tissue that has proliferated onto the cornea.~     Ultraviolet radiation and hot, dusty, windy, dry, smoky environments are regarded as risk~     factors for pterygium . Surgical removal is the treatment of choice, and surgical wound~     intraoperative and inflammatory response postoperative have been considered two of the most~     significant factors that can increase the recurrence rate of pterygium. Low-Temperature~     Plasma Surgery System(LTP), avoids causing burn injuries to patients, has been introducing~     into minimally invasive surgery. The mechanism by which this equipment stop bleeding and~     abolish tissue is to directly occupy the injury with the formed blood clots, plasma flows~     close the vessel and plasma active particles cause physical and chemical reactions with~     tissue. The different levels of energy density of plasma can affect the bacteria, cells and~     cancer cells and even to death, therefore it is widely used in the disinfection of medical~     devices, dental root canal therapy, skin disease treatment and surgical wound disinfection.~     Whether it's possible to apply the advantages and benefits of plasma technology in ophthalmic~     surgery? Like pterygium surgery? However, there is no research to answer until now. In this~     study, the investigators retrospectively observed the efficacy, postoperative discomfort,~     inflammation, complications, and recurrence rates in a group of patients for whose LTP was~     used in pterygium excision and wound hemostasis. The investigators Observe the clinical~     benefits of LTP in pterygium surgery and find the facilitates and problems it need to be~     addressed reasonably.~   "
27726|NCT03204058|"~     Metformin (MF), a biguanide group of anti-diabetic drug has been shown to enhance osteoblasts~     differentiation and inhibit osteoclast differentiation in vitro, thus may exhibit a~     favourable effect on alveolar bone. Statins are one of the lipid lowering drugs that help in~     reducing cholesterol levels in the body by specifically inhibiting 3-hydroxy-3-methylglutaryl~     coenzyme A reductase; which is a rate limiting enzyme for cholesterol synthesis. Rosuvastatin~     (RSV) have shown to have bone stimulatory and anti-inflammatory effects.Statins are one of~     the lipid lowering drugs that help in reducing cholesterol levels in the body by specifically~     inhibiting 3-hydroxy-3-methylglutaryl coenzyme A reductase; which is a rate limiting enzyme~     for cholesterol synthesis. Rosuvastatin (RSV) and atorvastatin (ATV) have shown to have bone~     stimulatory and anti-inflammatory effects.. The present study aims to explore the efficacy of~     1.2% RSV and 1MF gel as a local drug delivery and redelivery system as an adjunct to scaling~     and root planing (SRP) for the treatment of intrabony defects.~   "
27727|NCT03204045|"~     This study was performed to compare the effects of oxycodone and fentanyl on airway and~     hemodynamic responses and postoperative pain during recovery period in patients undergoing~     laparoscopic cholecystectomy.~   "
27728|NCT03204032|"~     A Phase II Randomized,Controlled,Open Label,Multicentre Study to evaluate the efficacy and~     safety of Tegafur combined with Temozolomide versus Tegafur combined with Temozolomide and~     Thalidomide in subjects with Advanced Extrapancreatic Neuroendocrine Tumor~   "
27729|NCT03204019|"~     A Phase II Randomized,Controlled,Open Label,Multicentre Study to evaluate the efficacy and~     safety of Tegafur combined with Temozolomide versus Tegafur combined with Temozolomide and~     Thalidomide in subjects with Advanced Pancreatic Neuroendocrine Tumor~   "
27730|NCT03204006|"~     Attenuation of Hemodynamic Response to Laryngoscopy and Endotracheal Intubation With Single~     Dose of Dexmedetomidine in Hypertensive Patients.~   "
27731|NCT03203993|"~     This is a prospective, multi-center, observational study, the primary objective is to~     evaluate the prevalence of gBRCA/sBRCAm in newly diagnosed ovarian cancer patients and~     explore ovarian cancer treatment outcomes of different BRCAm status.~   "
27732|NCT03203980|"~     The optimal antithrombotic therapy for patients requiring anticoagulation after coronary~     stenting is unknown. Double platelets suppressive agents combined with oral anticoagulation~     (triple antithrombotic therapy) remains the Gold standard.~      Our study aims at studying bleeding events occurring until 6 months after the initiation of~     triple antithrombotic therapy.~   "
27733|NCT03203967|"~     Single femoral nerve blockade combined with patient-controlled intravenous analgesia are used~     for postoperative analgesia for patients after TKA in the hospital of the investigators.~     Although this method provides acceptable analgesia, the incidence of opioid-associated side~     effects is relatively high. Low-dose epidural morphine is commonly used in postoperative~     analgesia after cesarean section, and the effect of single dose morphine lasts more than 20~     hours, with low incidences of itching, nausea, vomiting, and respiratory depression. The~     investigators hypothesize that, for patients undergoing TKA, the addition of low-dose~     epidural morphine to single femoral nerve block and intravenous opioids can improve the~     postoperative analgesia, reduce the consumption of intravenous opioids and decrease~     opioid-associated side effects.~   "
27734|NCT03203954|"~     Major depression is a prevalent and impairing illness. To better understand the basic science~     and treatment of depression, the investigators study the behavioral and brain processes~     associated with learning in depression and how potential disruptions in learning may be~     repaired. Understanding different methods that change learning may lead to novel treatments~     that contribute to recovery in people with depression.~   "
27735|NCT03203941|"~     Individual patient expanded access protocol for a child with cerebral palsy (CP) who has~     autologous umbilical cord blood available and who is ineligible to participate in other stem~     cell studies for children with CP.~   "
27736|NCT03203928|"~     Although woman are diagnosed with Attention-deficit hyperactivity disorder (ADHD) at a 1:3~     ratio with men, recent research suggests that woman may experience the same levels of adult~     ADHD as men but are underdiagnosed because symptoms may be less severe and/or mistaken for~     anxiety and depression. Women with ADHD typically experience problems in managing worker,~     student, spousal, and parenting roles dues to disorganization, poor time management,~     difficulty regulating internal and external stressors, and difficulty maintaining daily~     schedules and routines. Intervention effectiveness research has largely focused on~     pharmacological treatment of ADHD symptoms; however, while such pharmacological treatment~     tends to enhance concentration and reduce motor restlessness, it does not address the skills~     needed to successfully carry out daily life roles and activities dependent upon time~     management, prioritization of tasks, and regulation of emotional responses within the home,~     school/work, and community environments. In this study, the investigators aim to determine~     whether a 7-week tailored occupational therapy intervention addressing organization, time~     management, stress management, and sensory regulation in the home, school/work, and community~     environments can increase satisfaction in desired daily life activities, and reduce ADHD~     symptoms and stress levels in women with ADHD.~   "
27737|NCT03203915|"~     To determine if the addition of chardonnay grape pomace powder enriched with grape seed~     extract to the diet will result in reducing blood levels of cholesterol or triglycerides.~   "
27738|NCT03203902|"~     Many formerly homeless adults with chronic mental illness experience treatment resistant~     symptoms for which pharmaceutical agents and cognitive behavioral therapy are not effective.~     Although formerly homeless adults with chronic mental illness typically receive medical and~     psychiatric services to manage their illness, chronic stress and post-traumatic stress~     disorder (PTSD) acquired from homelessness are difficult to resolve and many adults~     experience relapse that can result in housing loss. Therapeutic touch is a complementary and~     alternative treatment that has been shown to be effective at reducing stress, anxiety, and~     pain in a variety of diagnoses including cancer, cardiac disease, chronic pain syndromes, and~     PTSD in veterans. In this study the investigators aim to determine whether a 30-minute~     therapeutic touch session combined with a conventional 1-hour psychoeducation group delivered~     over 6 weeks can more effectively reduce stress compared to conventional psychoeducation~     alone. The ability to reduce stress levels and maintain emotional equilibrium is critical for~     this population to manage illness symptoms effectively and stave off the incidence of~     relapse, rehospitalizations, and housing loss.~   "
27739|NCT03203889|"~     It is important to address the substantial substance-related health disparities of American~     Indians (AI). This project aims to examine the effectiveness of a culturally tailored~     Community Reinforcement and Family Training (CRAFT) approach and Twelve-step facilitation~     with Concerned Signficant Others (TSF-CSOs) among AIs to increase engagement of treatment~     refusing individuals into treatment/healing and to reduce distress of their loved ones. Study~     hypotheses are that (1) CRAFT will result in higher numbers of people entering treatment for~     substance use disorders than will TSF-CSO, (2) both groups will yield similar improvements in~     the family member's functioning, and (3) we will explore potential factors of the treatments~     to see which aspects of the treatment are most important and to test which characteristics of~     the clients impact the outcomes for better or worse. This knowledge may impact dissemination~     and diffusion efforts for CRAFT-AI and other evidence-based treatments among AIs and other~     culturally diverse groups.~   "
27740|NCT03203876|"~     The purpose of this study is to determine whether lirilumab in combination with nivolumab or~     in combination with nivolumab and ipilimumab is safe in the treatment of advanced and/or~     metastatic solid tumors~   "
27741|NCT03203863|"~     The purpose of this study was to cross-sectionally evaluate nutritional status and the~     metabolic syndrome in a sample of school-age children 10-15 years of age from 20 public~     schools in Santiago, Chile. In addition, the investigators retrospectively assessed the~     association of those variables with perinatal variables (birth weight, birth length, and~     gestational age at delivery).~   "
27742|NCT03203850|"~     The purpose of this study is to evaluate the efficacy and safety of deferasirox film coated~     tablet (FCT) versus phlebotomy for the management of iron overload in adults with HH at risk~     of iron-related morbidity. This evaluation will provide information on the two treatment~     options in terms of the rate of response of proportion of patients reaching the study target~     SF ≤ 100 μg/L and their associated safety profiles.~      In addition to exploring the safety and efficacy of deferasirox FCT in hereditary~     hemochromatosis (HH), this study is being conducted to fulfill an FDA post-marketing~     requirement [PMC 750-10 (Exjade) /PMR 2888-8 (Jadenu)] to provide additional randomized data~     to confirm the ocular safety profile of deferasirox through detailed ocular assessments in~     patients treated with deferasirox FCT for 2 years.~   "
27743|NCT03203837|"~     To analyze specific angiogenic, inflammatory and immune profiles in hepatocellular carcinoma~     patients who undergo radioembolization.~   "
27744|NCT03203824|"~     The purpose of this graduate student study is to determine if ingestion of dark chocolate~     (70% cacao) will change brain frequencies between visualization at a state of rest and a~     state of exercise performance via electroencephalography (EEG) in vigorously active~     individuals.~   "
27745|NCT03203811|"~     Single Center, Randomized, Double Blind, Placebo Controlled, Single ascending dose trial at 3~     levels. Ten subjects will be enrolled at each dose.~   "
27746|NCT03203798|"~     In the current scientific literature, it is clear that SUI can cause several social, hygienic~     and personal relationship problems. It has also been proven that this condition affects many~     more menopausal women than menacme, and this is believed to be due to the hypoestrogenism~     characteristic of this phase.~      On the other hand, weakness of the pelvic floor muscles (PFM) is also related to the genesis~     of SUI. The role of these muscles would be to keep the bladder neck elevated (above the pubic~     symphysis) during increases in abdominal pressure, and its weakness would lead to excessive~     lowering of the bladder neck at these times, leading to SUI due to bladder neck~     hypermobility.~      The conservative treatment of this condition, therefore, encompasses the strengthening of~     PFMs, which would avoid excessive descent of the bladder neck during increases in abdominal~     pressure, thereby reducing urinary loss.~      In the current literature there are studies proving the effectiveness of pelvic floor muscle~     training; however, in relation to the literature on abdominal hipopressive gymnastics, it is~     observed that the scientific evidence is still poor, however, the technique is still Widely~     spread through extension courses offered throughout Latin America, France and Spain; With~     regard to the comparison of these methods with respect to their clinical efficacy and the~     quality of life and patient satisfaction, there are no consistent studies, and this fact~     motivated us to carry out this study.~   "
27747|NCT03203785|"~     The study is a randomized, double-blinded, placebo-controlled trial that will include the~     participation of 14 Jiu-Jitsu athletes between 18 and 33 years. The aim of the study is to~     evaluate the effects of carbohydrate consumption on fatigue and exercise-induced muscle~     damage in Jiu-Jitsu athletes.~   "
27748|NCT03203772|"~     Investigating how neuropathic limb pain, including phantom limb pain or complex regional pain~     syndrome, is affected by virtual reality. While several studies have looked into virtual~     reality for treating this type of pain, few have used the latest immersive virtual reality~     hardware combined with motion control for an engaging virtual mirror therapy experience. The~     investigators are interested in studying the use of virtual reality as an alternative~     treatment option for these conditions.~   "
27749|NCT03203759|"~     The investigators propose a home hospital model of care that substitutes for treatment in an~     acute care hospital. Limited studies of the home hospital model have demonstrated that a~     sizeable proportion of acute care can be delivered in the home with equal quality and safety,~     reduced cost, and improved patient experience.~   "
27750|NCT03203746|"~     Effect of Locally Delivered Antioxidants as An Adjunct to Non-surgical Periodontal Therapy on~     GCF Level of Oxidative Stress Marker; Protein Carbonyl~   "
27751|NCT03203733|"~     This study evaluates, among study patients with lymphoma or myeloma undergoing autologous~     SCT, whether cooling oral mucosa with a cooling device compared with ice cubes/crushed ice or~     ice pop succeeds in reducing the degree of oral mucositis (OM) according to the Oral~     Mucositis Assessment Scale (OMAS) total,degree of OM according to World Health Organisation~     (WHO), tolerability of either cooling method. The study is also aiming to , patients~     subjective experience of OM, rating of general quality of life and oral pain, number of days~     with total parenteral nutrition (TPN), number of hospital days, total dose of opioids, and C~     reactive protein during time in care.~      Finally, the study aims to evaluate weight loss, Leukocyte particle concentration, number of~     days until bone marrow response, S-albumin, and body temperature.~   "
33251|NCT03131791|"~     Botulinum toxin type A (BoNT-A) is widely used in the clinics to reduce spasticity and~     improve upper limb function for post-stroke patients. However, there were no studies to~     compare the effect of rESWT and BoNT-A injection for treatment on spasticity.~   "
27752|NCT03203720|"~     Adolescence is the peak onset period for serious and persistent psychiatric disorders.~     Treatment guidelines for management of major psychiatric disorders in youth include~     pharmacotherapy. There has been substantial progress in recent years in identifying effective~     medications for youth with psychiatric disorders. However, adherence to prescribed~     medications among psychiatric populations is notoriously low, and adolescents rank among the~     least adherent of all patient populations. Given that the consequences of poor medication~     adherence among youth with chronic mental illness are far-reaching, including~     hospitalization, poor functioning, and suicide, there is a desperate need for interventions~     targeting medication adherence in this population.~   "
27753|NCT03203707|"~     Bipolar disorder is a severe and chronic illness associated with significant occupational and~     social impairment, enormous public health costs, and high rates of suicide. The single most~     potent risk factor for the development of bipolar disorder is a first-degree family member~     with the illness; indeed, offspring of parents with bipolar disorder are a particularly~     high-risk group who typically display early onset and severe course of illness. Thus, early~     assessment and intervention for the children of parents with bipolar disorder focused on~     specific, measurable, and modifiable risk factors has the potential to prevent or ameliorate~     the progression of bipolar disorder in those at highest risk.~   "
27754|NCT03203694|"~     The purpose of the present study is to determine the effects of increased walking and~     unilateral leg heating on leg vascular function in patients with type 2 diabetes (T2D).~   "
27755|NCT03203681|"~     Low testosterone affects more than 10% of men worldwide, with high incidence in the~     elderly.This will be a prospective case study. The investigators will identify men with~     hypogonadism in our clinic interested in Natesto for testosterone replacement therapy (TRT).~     Natesto is a relatively new form of testosterone replacement therapy that is delivered~     intranasal to men diagnosed with low testosterone. Current advantages to Natesto include ease~     of delivery and decreased risk of transference. Recently Natesto 4.5% (125 uL/nostril, 11.0mg~     testosterone/dose), three times a day (TID) dosing was shown to also increase serum~     testosterone while maintaining normal, though decreased, serum levels of Luteinizing Hormone~     (LH) and Follicle-Stimulating Hormone(FSH). 40 participants will be enrolled and receive~     treatment with Natesto.The study will identify men with confirmed hypogonadism (testosterone~     (T) <350 on 2 consecutive Testosterone samples collected greater than 1.5 hours apart between~     6am and 10am with demonstrated symptoms of hypogonadism). Participants with a history of~     prostate cancer, testis cancer, azoospermia, or genetic cause of hypogonadism will be~     excluded.~   "
27756|NCT03203668|"~     To assess the efficiency of 18F-fluorocholine PET/CT in localization of hyperfunctioning~     parathyroid tissue in hyperparathyroidism, thereby enabling minimally invasive surgical~     approaches with fewer complications and comparable success rates~   "
27757|NCT03203655|"~     Hispanic populations in the US are dis-proportionally affected by high rates of obesity and~     diabetes; according to the Centers for Disease Control and Prevention, Latinos are the~     minority group with the second-highest obesity prevalence in adults. In comparison to the~     general female population (61.2%), Mexican American women (73%) have a greater overweight or~     obese percentage. In addition, more than 50% of Hispanic men and women are expected to~     develop type-2 diabetes over their lifetime, compared to 40% among whites. Hispanics are also~     50% more likely to die from diabetes compared to whites. In many cases Hispanic populations~     do not have the knowledge, self-confidence and resources to participate in mainstream~     physical activity and nutrition interventions, which are usually geared towards the general~     population without considering cultural and linguistic differences.~      Information and communication technologies in the form of Internet and mobile phone access~     have grown enormously during the past decade; these technologies have the potential to affect~     food intake and physical activity as well as weight loss. Approximately 95% of countries have~     mobile telephone networks and about 70% of people worldwide use mobile phones.~      CareMessage is a Google-backed 501(c)3 nonprofit technology organization based in San~     Francisco that uses 'smart' text and voice messaging to enable clinical staff to provide~     automated yet personalized support to patients struggling with chronic conditions. The~     CareMessage™ Adult Obesity texting program adapts the Health Belief Model by strategically~     implementing behavioral concepts to help improve self-efficacy.~      The investigators will pilot test its effectiveness among a sample of Hispanic women who are~     at risk of obesity and diabetes by sending a culturally-sensitive and~     linguistically-appropriate text-based message three to 5 times a week, encouraging lifestyle~     modifications (diet and exercise education and behavior modification).~   "
27758|NCT03203642|"~     The goal of the study is to compare and evaluate safety and efficacy of tesevatinib 50mg~     versus placebo in patients with ADPKD.~   "
27759|NCT03203629|"~     To conduct a prospective, observational study to evaluate the non-interventional feasibility~     of using heart sounds measurements recorded by the LifeVest® Wearable Cardioverter~     Defibrillator (WCD) for monitoring clinical evidence of heart failure decompensation.~   "
27760|NCT03203616|"~     Women with breast cancer often develop metastases in the brain. Currently, treatment of these~     metastases is difficult and relies on radiotherapy or surgery which often fail. Therefore,~     development of new methods of treatment for breast cancer with brain metastasis is very~     important. T-DM1 is a drug that is already in everyday use for a specific type of breast~     cancer called HER2-positive breast cancer. The objective of this study is to investigate~     whether T-DM1 is also effective in brain metastasis and can help patients to live longer and~     better~   "
27761|NCT03203603|"~     The overall aims of this protocol are to determine whether prenatal supplementation with~     vitamin C to pregnant smokers can improve pulmonary function and decrease wheeze at 5 years~     of age in their offspring. This is a continuation of the VCSIP trial, to follow the offspring~     through 5 years of age. The hypothesis for this protocol is an extension of the VCSIP trial~     that supplemental vitamin C in pregnant smokers can significantly improve their children's~     PFTs and decrease the incidence of wheeze.~   "
27762|NCT03203590|"~     The purpose of this study is to evaluate the efficiency and safety of Gefitinib Neoadjuvant~     Therapy and Oral Navelbine Carboplatin Neoadjuvant Therapy for Resectable Stage Ⅱ-ⅢA NSCLC~     patients with EGFR mutation.~   "
27790|NCT03203226|"~     Loss of functioning and age-related health problems tend to appear earlier in individuals~     with intellectual disability (ID) than in their non-disabled peers and due to this people~     with ID who are in employment tend to need to retire earlier, producing social, economic and~     health problems. The Feldenkrais method (FM) is a movement-based form of learning that~     enhances body balance and physical functioning. We hypothesized that the FM could be helpful~     to improve balance and functioning of employed people with ID.~   "
34903|NCT03109717|"~     Study TRD subjects' resistance to at least 2 different antidepressants, we hypothesize that~     because of their significant depression and treatment resistant status they are most likely~     to exhibit BSMN pathway abnormalities.~   "
27763|NCT03203577|"~     Objective: To prove that initiation of chronic ventilatory support at home, in patients with~     chronic hypercapnic respiratory failure due to neuromuscular disease (NMD) or thoracic cage~     problem is not inferior compared to initiation in a hospital based setting. In addition we~     believe that the start at home is cheaper compared to an in-hospital start.~      Hypothesis: Initiation of chronic ventilatory support at home is effective, safe and cost~     effective compared to a hospital-based initiation.~      Study design: A nationwide non-inferiority multi-center randomized parallel active control~     study.~      Study population: Patients with chronic respiratory insufficiency due to a neuromuscular~     disease (NMD) or thoracic cage problem who are referred for chronic ventilator support.~      Intervention: The start of HMV at home Standard intervention to be compared to: The start of~     HMV is normally in a clinical setting as recommended in the national guideline.~      Outcome measures: Primary: PaCO2. Secondary: Health related quality of life; lung function;~     nocturnal transcutaneous carbon dioxide assessment and saturation, and costs Sample size~     calculation/data analysis: This is a non-inferiority trial based on PaCO2 as primary outcome.~     A difference in favor of the hospital care group of smaller than 0.5 kPa will be labeled as~     non-inferior. To retain 72 evaluable patients, and allow for drop-outs, we will include 96~     patients in total.~      Cost-effectiveness analysis: A cost analysis will be conducted alongside the clinical trial.~     Costs of the initiation of HMV at home and in the hospital will be estimated form a societal~     perspective over a time horizon of 6 months.~      Time schedule: After an initial phase of 6 months recruitment will start and will take 24~     months. Thirty-six months after the start of the study the last assessments will be done and~     analysis and writing of the papers will start. After 42 months the study will end.~   "
27764|NCT03203564|"~     The purpose of this study is to evaluating ECG effects, safety, tolerability and~     pharmacokinetics of single ascending dose of Modufolin® in healthy male volunteers~   "
27765|NCT03203551|"~     This clinical study identified the Candida species from the palate and complete dentures of~     edentulous individuals with prostheses-related stomatitis (PRS) and evaluated the effect of~     disinfectant solutions for denture hygiene on Candida spp. Sixty participants were randomly~     assigned in 04 parallel groups (n = 15); They were oriented to brush their prostheses and the~     palate 3 times a day and immerse them in saline solution (C-control), 0.25% Sodium~     hypochlorite (HS0.25%), 10% Ricinus communis (RC10%) or 0.5% Chloramine T (CT 0.5%) for 20~     minutes. Biofilm samples were collected from the prostheses and palate in the baseline, after~     7 and 37 days of use of the solutions and seeded in CHROMagar Candida medium. After~     incubation period, the presumptive identification, incidence verification and quantification~     of Candida species growth (CFU count) were performed. To quantify biofilm with software~     ImageTool 3.0, the inner surface was disclosed (1% neutral red) and photographed at the end~     of each period. The Candidiasis remission was assessed by scores before and after the use of~     solutions by palate's phographs. Descriptive analyzes were used for the identification and~     incidence of Candida spp. Kruskal-Wallis and Friedman tests, with stepwise step-down~     post-test for cell growth; ANOVA and Tukey for biofilm removal; Frequency of scores for~     evolution of inflammation. Level of significance was 95%. The most incident species were C.~     albicans, followed by C. tropicalis, C. glabrata and C. krusei. HS 0.25% reduced the~     incidence of the three species on the prostheses and palate in the periods of 7 and 37 days;~     CT 0.5% promoted reduction of Candida spp. only in dentures. R. communis decreased the~     incidence of C. tropicalis in both collection sites. For CFU counts, HS 0.25% and CT 0.5%~     caused significant reduction. For biofilm removal, HS0.25% was the most effective (9.75 ±~     12.6) and RC10% (15.92 ± 14.8) intermediate. All groups decreased protheses-related~     stomatitis. HS0.25% has potential for clinical use as total denture disinfectants. RC10% and~     CT0.5% require further studies to be indicated as alternative solutions.~   "
27766|NCT03203538|"~     The project will contribute with new knowledge concerning how aspects of the physical work~     environment (lighting conditions) can be arranged to facilitate the workers' adaptation to~     night work. This is important given the reported adverse consequences of shift work for~     performance, safety, and health. The project involves a series of three experimental,~     laboratory based shift work simulation studies. The aim is to investigate how different~     lighting conditions (intensities and colour temperature), administered through light emitting~     diode (LED) based bright light integrated standard room lighting, affects adaptation to three~     consecutive simulated night shifts and re adaptation to a day oriented schedule on measures~     of alertness, cognitive performance, sleep and circadian rhythm. The proposed project~     examines the effects of interventions that can be applied in naturalistic settings and will~     be based on new laboratory infrastructure available at the laboratories situated in the~     Faculty of Psychology, University of Bergen.~   "
27767|NCT03203525|"~     The goal of this clinical research study is to find the highest tolerable dose of 2 study~     drug combinations that can be given with the NovoTTF-100L system at 150kHz. The NovoTTF-100L~     System is a portable device that uses electrical fields to stop the growth of tumor cells.~      The first study drug combination is modified FOLFOX6 (folic acid, leucovorin, fluorouracil,~     and oxaliplatin) mFOLFOX6 and bevacizumab. The second study drug combination is liposomal~     doxorubicin, bevacizumab, and temsirolimus. Patients in both combinations will also receive~     treatment with the NovoTTF-100L system.~      The safety of these combinations will also be studied.~   "
27768|NCT03203512|"~     N-3 polyunsaturated fatty acids (n-3 PUFA), which are abundant in oily fish and fish oils,~     have been suggested to play a role in reducing the risk of cardiovascular diseases (CVDs) by~     modifying a wide range of risk factors, such as blood fats, blood clotting, blood vessel~     function and inflammation. Extracellular vesicles (EVs) are small particles released from~     various cells when they are activated or damaged. High numbers of EVs in the blood have been~     associated with a higher risk of CVDs, and it is thought that this is because they carry~     'bioactive' components which can affect many processes involved in CVDs. However, very few~     clinical trials have investigated the relationships between the consumption of n-3 PUFA and~     circulating EVs. This study aims to investigate the effects of dietary n-3 PUFA on the~     generation and functional activities of EVs, which would provide new insight into the~     benefits of n-3 PUFA on cardiovascular health.~   "
27769|NCT03203499|"~     This is a single-center, randomized, double-blind, placebo-controlled, single-ascending-dose~     study to evaluate the safety and tolerability of the coadministration of up to 6 dose levels~     of ANS-6637 and EtOH in healthy male moderate alcohol drinkers. The study will include a~     screening visit, a qualification visit, a Treatment Phase and follow-up.~   "
27770|NCT03203486|"~     The effects of Mediterranean Diet (MedDiet) on clinical, biochemical and inflammatory profile~     in NAFLD patients with simple steatosis. Potential associations of single nucleotide~     polymorphisms to diet composition and patients' profile were also investigated.~   "
27771|NCT03203473|"~     This research study is studying two drugs at different time points as a possible treatment~     for advanced renal cell cancer~      The drugs involved in this study are:~      Nivolumab Ipilimumab~   "
27772|NCT03203460|"~     The broad goal of the Exercise During Active Surveillance for Prostate Cancer (ERASE) trial~     is to examine the effects of exercise in prostate cancer patients undergoing active~     surveillance.~   "
27773|NCT03203447|"~     This Phase 3, multicenter, randomized, masked, controlled, parallel group study is designed~     to demonstrate that suprachoroidal (SC) CLS-TA administered with intravitreal (IVT) anti-VEGF~     agent in subjects with treatment naive RVO is superior to IVT anti-VEGF agent used alone.~   "
28947|NCT03188094|"~     The proposed study will inform efforts to prevent diabetes and promote weight loss in a~     high-risk population and generate a reproducible, scalable, and sustainable model for use~     with other insurer groups and clinical settings that work in immigrant populations with a~     high burden of chronic disease.~   "
27774|NCT03203434|"~     Esophagectomy or pancreaticoduodenectomy is the standard surgical approach for patients with~     malignant tumors of the esophagus or pancreatic head. These procedures are associated with~     high morbidity rates, which are strongly correlated with the occurrence of anastomotic~     leakage. Current diagnostic methods, including clinical, biochemical and radiological~     techniques are frequently inconclusive. Delay in diagnosis leads to delay in treatment, which~     ratifies the need for development of novel and accurate non-invasive diagnostic tests for~     detection of anastomotic leakage. Urinary volatile organic compounds reflect the metabolic~     status of an individual, which is associated with a systemic immunological response. The aim~     of this study was to determine the diagnostic accuracy of urinary volatile organic compounds~     to detect anastomotic leakage after esophagectomy or pancreaticoduodenectomy in an early~     phase.~   "
27775|NCT03203421|"~     The purpose of this study is to assess the safety, immunogenicity and efficacy of the~     candidate malaria vaccines ChAdOx1 LS2 and MVA LS2.~      Healthy adult volunteers will be recruited and vaccinated in Oxford.~   "
27776|NCT03203408|"~     The main objective of the study was to demonstrate the non-inferiority of the efficacy of a~     single intra-articular injection of OSTENIL PLUS compared to that of a single intra-articular~     injection of the reference product SYNVISC-ONE in the treatment of symptomatic tibiofemoral~     osteoarthritis. The primary endpoint was the change in mean score on the WOMAC pain scales~     from D0 to D180.~   "
27777|NCT03203395|"~     Depression is a risk factor for morbidity and mortality in patients with heart disease, and~     has a negative impact on quality of life, work capacity and treatment adherence. Screening~     for depression among heart patients are therefore recommended by the Norwegian Health~     Authorities. Also, symptoms of anxiety may negatively affect rehabilitation due to e.g. fear~     of physical activity and excessive worry. Patients currently receiving treatment for heart~     disease at Diakonhjemmet Hospital will be screened for symptoms of depression and anxiety. If~     such symptoms are detected, patients will be offered a counselling session with a clinical~     psychologist. Further, routines for collaborative communication between clinical~     psychologist, cardiologist and the patient's general physician will be emphasized.~   "
27778|NCT03203382|"~     Patients who are suspected of or diagnosed with Sjogren's disease will be evaluated for~     ocular symptoms and corneal nerve morphology. We are specifically interested in the~     relationship between Vitamin D level and aberrations in the morphology of the corneal nerves.~   "
27779|NCT03203369|"~     A Phase 1 dose-finding study of Universal Chimeric Antigen Receptor T-cells targeting cluster~     of differentiation (CD) 123 (UCART123) administered intravenously to patients with relapsed~     or refractory Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), followed by a dose~     expansion phase in relapsed or refractory BPDCN patients or newly diagnosed BPDCN patients.~   "
27780|NCT03203356|"~     To evaluate in children affected by idiopathic GHD the adrenal function both at baseline and~     after 6 and 12 months of GH treatment.~   "
27781|NCT03203343|"~     Today there are various surgical techniques for inguinal hernia. In this study, investigators~     want to compare the ''PIRS'' operating technique laparoscopy and modified Marcy operating~     technique with open inguinal access. Investigators would compare both groups to find out~     witch one does the lesser inflammatory stress response on the organism.~   "
27782|NCT03203330|"~     A randomized, double-blind, placebo-controlled, multi-center, phase 3 study to determine the~     safety and efficacy of TG-C in subjects with Kellgren and Lawrence Grade 2 or 3~     Osteoarthritis of the Knee, Osteoarthritis Research Society International (OARSI) medial~     joint space narrowing (JSN) Grade 1 or 2 of the knee joint. TG-C is to be administered by a~     single intra-articular injection to the damaged joint area via ultrasound guidance. Patients~     will be followed for 24 months for safety and efficacy.~   "
27783|NCT03203317|"~     The study will investigate myocellular signalling in skeletal muscle after~     insulin-stimulation and exercise in healthy young men~   "
27784|NCT03203304|"~     External beam photon stereotactic body radiotherapy (SBRT) using a linear accelerator to a~     total dose of 40 Gy in 5 fractions delivered once daily with at least 48 hours between each~     fraction. SBRT treatment will be completed within a 21-day window. Starting within 14 days~     after completion of SBRT, intravenous nivolumab 240 mg will be given every 2 weeks as~     monotherapy or in combination with ipilimumab 1 mg/kg IV every 6 weeks.~   "
27785|NCT03203291|"~     There are a number of common impairments resulting from stroke that contribute to motor~     deficits which affect gait, or walking ability. These manifest as decreased walking speed,~     and further, as stroke affects only one side of the body, there are resulting asymmetries in~     time, spatial and force parameters during walking. Robotic-based therapies have been used to~     increase walking speed and reduce asymmetry in a population of individuals after stroke,~     however these therapies have demonstrated results similar to that of non-robotic, or~     conventional training. This is possibly due to the control strategies used in robotic~     training, which strategies limit participant involvement and reduce learning effect. The~     Tethered Pelvic Assist Device (TPAD) is a robotic device that uses motorized tethers attached~     to a belt at the user's pelvis to guide the pelvis along a pre-set movement trajectory. These~     tethers can be configured in an infinite array of possibilities, and most recently have been~     used to facilitate a body weight shift onto the paretic limb in a population of individuals~     after stroke. Other robotic devices constrain the limb through the entire movement trajectory~     and constrict the participants ability to participate in motor planning and movement~     execution. The TPAD promotes weight shifting, but allows an individual to freely move the~     limb and to navigate leg movement and foot placement independently, without constraints.~     Further, if coupled with overground training to promote transfer of improvements to walking~     over ground, this device maybe useful at improving symmetry in individuals after stroke.~     OBJECTIVES: The purpose of this study is to evaluate the overall feasibility in terms of~     safety, treatment tolerance and adherence as well as preliminarily address how effective this~     treatment model using the TPAD and overground training would be to reduce load asymmetry on~     the treadmill and promote increased stance symmetry on the paretic limb during overground~     gait.PARTICIPANTS: A total of 12 individuals in the chronic (>6 months) stages post stroke~     will be recruited from a voluntary stroke research database for participation. DESIGN: A~     non-randomized pilot study of feasibility will be used to establish the feasibility and~     preliminary efficacy of using the TPAD in combination with overground training to reduce load~     force asymmetry in this population. METHODS: Participants will undergo a series of three~     assessments within a one-week time frame prior to initiating intervention. Intervention using~     the TPAD and overground training will occur during week 2 over 5 consecutive visits~     (Mon-Fri). Participants will also complete short walks before and after the intervention with~     an instrumented system that records individual walking characteristics. Participants will~     return one-week after completing the intervention for a final test of walking and balance.~     Each study visit will be approximately 1-1.5 hours in duration, and total participation~     should be completed within three weeks. EXPECTED OUTCOMES: We anticipate this training~     paradigm will prove feasible and effective in reducing both load and stance asymmetry in a~     population of individuals with chronic stroke.~   "
27786|NCT03203278|"~     This randomised controlled trial aims to investigate the effect of a 12 week personalised~     exercise programme delivered using a web-based platform, compared to usual care, on glycaemic~     control, muscle strength, functional ability, blood lipid profile, blood pressure and quality~     of life in adult South Asians with Type 2 Diabetes Mellitus~   "
27787|NCT03203265|"~     This study will ask Thai MSM and transgender women (TG) participants to self-select to~     participate in one of the 3 different study groups which provide various degrees of~     integrated online interventions and offline interventions for the Recruit-Test-Treat-Retain~     for HIV prevention and care among 3 groups (A, B1 and B2). All participants will be followed~     up either offline or online for 12 months. HIV-negative participants will be scheduled for~     repeat HTC at months 6 and 12. HIV-positive participants will be scheduled either offline or~     online to review their treatment history at months 6 and 12. HIV-negative participants in~     Group B1 and B2 can choose again at months 6 and 12 to switch from the online to offline, and~     vice versa, at the HIV testing/post-test counseling step and the referral to HIV treatment~     step~   "
27788|NCT03203252|"~     Measuring appearance of implant-based breast reconstruction after mastectomy for breast~     cancer - an online approach to research. Using 3-dimensional surface images we intend to~     create a tool to measure appearance after surgery in order to improve standards of care for~     women. We want to minimise the number of visits and amount of time involved in research~     participation so this pilot study will develop new online tools for information giving and~     gathering, and for consent so that only one visit to hospital will be required for~     photographs. This will also extend the availability of expensive 3D technology to more women.~   "
27789|NCT03203239|"~     Subjects with a known diagnosis of peripheral artery disease as measured by an abnormal ankle~     brachial index (<.9 or >1.1) will undergo a single 5 min exposure of 670 nm light, 1 cm above~     the gastrocnemius muscle. Blood flow will be measured by infusion of ultrasound contrast and~     subsequent acquisition of ultrasound images. 2 blood samples will be collected for~     measurement of nitric oxide metabolites.~   "
27793|NCT03203187|"~     In the current proposal the investigators seek to evaluate the acute and short-term effects~     of mango intake on vascular and platelet function in postmenopausal women between 50 and 70~     years old.~      Our aims are 1) to determine if two weeks of daily mango intake will result in favorable~     changes in measures of vascular function, as measured using peripheral arterial tonometry~     (PAT) and platelet reactivity, in overweight and obese postmenopausal women. 2) to determine~     if two weeks of daily mango intake will change the fermentation capacity of gut microbiota.~      Investigators hypothesize that the daily intake of 330 grams of mango (2 cups) will~     significantly increase PAT while reducing platelet aggregation after 2 hours and two weeks of~     daily intake.~   "
27794|NCT03203174|"~     Hyperhidrosis or sweating of palms results from the overactivity of sweat glands and leads to~     psychosocial impairment with reduction in quality of life in those that are affected.~     Injection of botulinum toxin has been shown to be effective in reducing the symptoms of~     hyperhidrosis with associated improvement in quality of life, but is usually very painful.~     Microneedles are a different modality for transdermal drug penetration without the pain. This~     study aims to understand if botulinum toxin A can be delivered topically after microneedle~     pretreatment in hopes of developing a minimally painful treatment protocol for treatment of~     palmar hyperhidrosis.~   "
27795|NCT03203161|"~     While bariatric surgery is established as a safe and effective alternative with well-defined~     risks for severely obese adults, little has been published on its use in children.~      There are many unresolved questions concerning the long-term metabolic and psychological~     consequences of bariatric surgery in adolescents, and the difference with the adult~     population. The appropriate timing for bariatric surgery in young people, and the predictors~     of success and safety still need to be determined.~      The aim of this long-term prospective study is therefore to establish the safety and efficacy~     profile of surgical procedures and to clarify whether reductions in morbidity and mortality~     outweigh the risks of serious surgical complications and lifelong nutritional deficiencies.~   "
27796|NCT03203148|"~     In this observational study a comparison is made between two different monitors for~     measurement of the activated clotting time (ACT): mechanical versus biochemical techniques~   "
27797|NCT03203135|"~     Staggered work affects about 20% of French employees and its health risks are now well known.~     They concern physical health (sleep disorders, weight gain, cancer, cardiovascular disorders,~     nutritional problems, etc.) and psychological health. Faced with these alarming findings,~     it is necessary to find ways of improvement and levers of action to prevent them.~      This project aims to set up and evaluate a nutritional health prevention programme for the~     benefit of employees in staggered hours from CITEO. CITEO is a company of social mediation.~      The objectives of the project are twofold: to evaluate the impact of working conditions in~     shifted schedules on food behavior and on to improve their eating behaviors.~      How? Focusing on the pleasure of eating through a nutritional prevention program in which~     various and varied actions will be proposed but always adapted to the life of the company~     (example: culinary demonstration, physical activity, provision of baskets of Fruits, etc.).~   "
27798|NCT03203122|"~     6 monthly treatments with IPL laser in patients with Hidradenitis Suppurativa. The effect in~     measured on several severity scores.~   "
27799|NCT03203109|"~     Retrospective cohort study of consecutive patients investigated in a neurorehabilitation ward~     after a first hemispheric stroke. Postural and gait disorders in relation to referential of~     verticality have been analyzed in routine care.~   "
27800|NCT03203096|"~     This study aims to determine how a 6-week magnesium supplementation with 400 mg magnesium~     from magnesium citrate/magnesium oxide affects stress parameters in students in exam~     preparation.~   "
27801|NCT03203083|"~     Single-leg squat (SLS) is a functional test visually rated by clinicians for assessing lower~     limb function as a preventive injury strategy. SLS clinical rating is a qualitative~     evaluation and it does not count objective outcomes as kinematics data and surface~     electromyography (sEMG) assessment. Based on the SLS rating, the aims of this study were (i)~     to determine the clinical rating agreement among six raters and (ii) to assess kinematic and~     sEMG predictors of good SLS performance in physically and non-physically active individuals.~   "
27802|NCT03203070|"~     A prospective randomized trial will be performed. Patients undergoing gastric bypass will be~     randomized into 2 groups: patients undergoing laparoscopic-guided transversus abdominis plane~     (TAP) block as part of multimodal analgesia (Group 1), associated with postoperative~     intravenous analgesia, and patients receiving only postoperative intravenous analgesia (Group~     2).~      Postoperative pain will be assessed with a Visual Analogic Scale 24h after surgery and~     morphine needs will be quantified.~   "
27803|NCT03203057|"~     Background Troponin are proteins found in the cardiomyocyte and are a cornerstone in the~     diagnoses of acute myocardial infarction. Troponin is released to the bloodstream as a result~     of an cardiomyocyte injury. Troponin is frequently assessed in hospital care for patients~     with chest pain and dyspnea.~      Guidelines recommend troponin assessment at admission and repeated at 3 to 6 hours, depending~     on the assay. High-sensitivity assays measure concentrations that are ten-times lower than~     earlier generations of assays. However, the time from when troponin is elevated in the~     bloodstream after an ischemic injury, measured with high-sensitivity assays, are not fully~     known.~      During an X-ray imaging of the heart's blood vessels (coronary angiogram) it is possible to~     do a short, controlled occlusion of coronary artery by inflating a small balloon in one of~     the coronary arteries. Numerous earlier studies in patients have used this method for induced~     occlusion of one coronary artery for 1 to 3 minutes. Only one of the studies measured~     troponin I.~      The aim with this study is to quantify and compare the release of troponin T and troponin I~     in the early hours after a controlled induced ischemia.~      Study Design This is a prospective, descriptive and experimental study. There will be~     included 40 patients, without acute ischemic cardiac disease. They will be randomized in 4~     groups.~      0: 10 patients - control group, no balloon occlusion~        1. 10 patients - balloon occlusion for 30 seconds~        2. 10 patients - balloon occlusion for 60 seconds~        3. 10 patients - balloon occlusion for 90 seconds~      Subsequently there will be assessed serial blood samples 0 - 3 hours: Every 15 minutes 3 - 6~     hours: Every 30 minutes~      Statistics This is a pilot study and it is estimated that ten patients are sufficient number~     of patients in each group to assess elevation of troponin after occlusion of coronary artery.~     The thesis is there is a dosage-response correlation between the length of balloon occlusion~     and the concentration of troponin in blood stream.~   "
27804|NCT03203044|"~     Soylent 2.0 is a popular meal replacement drink that is used to supplement or replace one's~     regular diet. Soylent is designed to fully fulfill one's nutritional needs, but its impact on~     the human microbiome remains unknown. This study aims to track the composition of~     participants' gut microbiomes before, during, and after Soylent consumption to more~     holistically understand its impact on microbiome health. We predict that a short term~     Soylent-based diet will induce observable and reversible changes to participants' gut~     microbiomes.~   "
27805|NCT03203031|"~     Postoperative pain scores and analgesic requirements will be evaluated in neonates after~     abdominal surgery, with regional quadratus lumborum block performed at the beginning of the~     procedure.~   "
27806|NCT03203018|"~     The current health literacy (HL) pilot intervention was designed through focus groups with~     women in low socio-economic status (SES) communities. The primary HL issue identified was~     communication challenges at doctors' visits. As a unique HL intervention tailored to the~     participants' preferences, this intervention can serve as a model for improving HL in similar~     communities worldwide.~      Objectives include increasing the percentage of women who utilize patient-doctor~     communication skills and increasing their cardiovascular disease (CVD) knowledge. A unique HL~     intervention tailored to the participants' preferences was designed which consisted of three~     workshops conducted in municipality-sponsored women's groups in low SES Jerusalem~     communities. Questionnaires were completed before and three months after the intervention.~     The study answers the following: Can HL workshops improve patient-doctor communication skills~     and CVD knowledge in low SES women?~   "
27807|NCT03203005|"~     This study is being carried out in order to evaluate a new cancer vaccine called IMA970A~     combined with CV8102, a new adjuvant for the treatment of liver cancer (hepatocellular~     carcinoma). It will be investigated whether IMA970A and CV8102 is safe and can trigger an~     immune response against the tumor, which may prevent the tumor (cancer) from recurring or~     spreading or may even lead to tumor shrinkage following the standard treatments the patients~     have previously received.~   "
27808|NCT03202992|"~     This study evaluates the use of ABI-1968, a topical cream, in the treatment of anal~     precancerous lesions in adults with and without human immunodeficiency virus (HIV) infection.~   "
27809|NCT03202979|"~     The aim of the study is to collect preliminary information on the effect of low doses of~     trazodone on pain intensity in patients with painful diabetic neuropathy and to evaluate the~     neuropathic pain symptoms, anxiety, sleep, quality of life, safety and tolerability.~   "
27810|NCT03202966|"~     This study is a cohort longitudinal design, also known as within subject repeated measures'~     design to measure the impact of an early identification and intervention program being~     implemented by Amar Seva Sangam (ASSA), an Indian non-government organization in South India.~     The primary objective of the Early Intervention (EI) Village-Based Rehabilitation (VBR)~     program is to increase access to early identification and early intervention therapy to~     enhance physical, cognitive, language, social and emotional development of children with~     developmental delays. The primary outcome will be the creation of developmental trajectory of~     girls and boys with developmental delay who are receiving village based early intervention~     therapy in rural India, aged 0 - 6 years based on the Gross Motor Function Measure - GMFM~     (children with cerebral palsy only), Functional Independence Measure - wee-FIM, Functional~     Assessment Checklist for Programming - FACP, Communication Developmental Eclectic Approach to~     Language Learning - CDDC and Canadian Occupational Performance Measure - COPM. Secondary~     outcomes will be the effect of therapy compliance rates on development in girls and boys with~     developmental delay, the effect of therapeutic approach on development in girls and boys with~     developmental delay, improved enrolment in school for children with developmental delays from~     age 3 to 6; and, improved parent/caregiver knowledge, attitude, behavior and confidence in~     caring for their child with developmental delay.~   "
27811|NCT03202953|"~     The purpose of this study is to compare the 1: 1 I: E ratio VCV and the autoflow VCV in~     patients undergoing robot assisted laparoscopic prostatectomy~   "
27812|NCT03202940|"~     This research study is studying a drug combination as a possible treatment for anaplastic~     lymphoma kinase-positive (ALK+) non-small cell lung cancer.~      The drugs involved in this study are:~        -  Alectinib~        -  Cobimetinib~   "
27813|NCT03202927|"~     This study will compare treatment emergent incidence rate of ADA between TPI-120 and US~     licensed Neulasta in normal healthy adult subjects~   "
27814|NCT03202914|"~     The present record represents a secondary data analysis of the Modification of Diet in Renal~     Disease (MDRD) Study. For this analysis, the MDRD study data and specimens were retrieved~     from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Central~     Repository. A global, untargeted, metabolomic profile was used to investigate biomarkers of~     dietary intake as well as biomarkers of kidney disease progression.~   "
27815|NCT03202901|"~     The goal of this study is to assess the short (acutte) effect of B-Turmactive (one week~     treatment) both on mild/moderate knee pain~   "
27816|NCT03202888|"~     This project aims to create and evaluate a tool that gathers patient and family member~     feedback and makes it rapidly available to providers, enabling nimble and responsive safety~     and quality improvement efforts. Aim 1. Determine feasibility and acceptability of the~     patient data collection and provider dashboard tool. The investigators will conduct usability~     testing prior to study start, measure user (patients and providers) engagement over time, and~     gather feedback about the tool at study end. This will test the hypothesis that patient and~     caregiver characteristics will predict tool use. Aim 2. Assess whether reporting patient- and~     caregiver- observed processes of care to providers leads to changes over time. The~     investigators hypothesize that performance on structured items of interest will improve over~     time with rapidly available data presented to providers. Aim 3. Estimate tool implementation~     effect sizes, using a pre-post design, on medical errors.~   "
27817|NCT03202875|"~     Primary Objective:~      To compare exposure and activity of SAR341402 to NovoRapid® and NovoLog®.~      Secondary Objective:~      To assess the safety and tolerability of SAR341402.~   "
27818|NCT03202862|"~     This is an open-label, single arm, phase II trial to evaluate the efficacy and safety of~     500mg Fulvestrant (Faslodex®) in ESR1 mutated postmenopausal women with hormone receptor~     positive, HER2 negative locally advanced or metastatic breast cancer after previous aromatase~     inhibitor therapy. Fifty patients will be enrolled and treated with 500 mg Fulvestrant until~     disease progression or study closed.~      Treatment will continue until disease progression, unless any of the criteria for treatment~     discontinuation are met first. If a patient progresses during the treatment period, the~     patient must be withdrawn from the treatment and further treatment will be at the~     investigator's discretion.~   "
27819|NCT03202849|"~     The investigators hypothesize that supplementation with vitamins A and D will reduce the~     incidence of acute gastrointestinal graft versus host disease (GI GVHD) compared with~     supplementation with vitamin D alone.~   "
27820|NCT03202836|"~     This study evaluates the addition of vaginal progesterone in the management of preterm labor.~     Half of participants will receive vaginal progesterone, tocolysis and corticosteroid, while~     the other half will receive only tocolysis and corticosteroid.~   "
27821|NCT03202823|"~     Diabetes is associated with an increased risk of cardiovascular complications, as a~     reflection of the chronic inflammatory status. Monocytes-macrophages in diabetic subjects~     present impaired arachidonic acid metabolism. Moreover, atheromatous plaques in diabetic~     subjects seem to be significantly enriched in 2-AA-LPC~     (2-arachidonoyl-lysophosphatidylcholine) and are more inflammatory and more likely to rupture~     than are plaques in non-diabetic subjects. We therefore hypothesize that this vulnerability~     of atheromatous plaques in diabetic subjects could be explained by impaired 2-AA-LPC~     metabolism within the plaque.~   "
27822|NCT03202810|"~     Oral cancer is a major health problem worldwide, accounting for 274,000 new cases and 145,000~     deaths annually. On average, half of the patients die within 5 years of an oral cancer~     diagnosis. Most troubling, however, is the lack of significant change in prognosis for this~     disease over the last 4 decades, even in developed nations. Even when successful, treatment~     of oral cancer can be devastating due to diminished quality of life and disfigurement. The~     key to controlling this disease is early identification of lesions that are at high risk of~     progression and provide effective treatment. The overall objective of the team is to~     integrate clinical, pathological, molecular, and imaging data to create a robust oral cancer~     risk model to predict the risk of progression of OPLs and to develop population-wide~     cost-effective prevention strategies for high-risk oral premalignancies. The project will~     involve 4 specific aims as described in detail below.~      Aim 1. To use molecular data to stratify low-grade OPLs into high- and low-risk groups.~      Aim 2. To evaluate the cost-effectiveness of various follow-up frequency that use LOH at~     chromosome 9p21 as a risk marker.~      Aim 3: To evaluate the specificity and sensitivity of using imaging technologies as a tool~     for the decision of the high-grade or high-risk biopsy site.~      Aim 4. To assess the clinical utility of a miRNA expression signature derived from serum~     collected from patients with oral cancer and OPLs.~   "
27823|NCT03202797|"~     360 million people in the world suffer from debilitating hearing deficiency. The cochlear~     implant is indicated in certain patients with severe profound deafness. The principle of the~     cochlear implant is to directly stimulate auditory nerve fibres by electrodes inserted in the~     cochlea. The steps in auditory rehabilitation are the surgical insertion of the cochlear~     implant, activation, and follow-up regulation. There is no formal consensus to define the~     exact modalities for regulation during activation or follow-up, but the principles are~     respected according to centres that regulate cochlear implant. Bimodal audition is the fact~     of having a cochlear implant and a contralateral hearing aid. In patients with cochlear~     implants, having binaural bimodal audition improves their auditory vocal performance in~     silence and in noisy environments. It needs to be considered when a second cochlear implant~     is not indicated for the contralateral ear. It has been shown that by allocating frequencies~     different from the default frequencies attributed by the manufacturer, intelligibility and~     perception of music are modified. The investigators therefore with to study this working~     hypothesis and to develop a simple protocol for the reallocation of frequencies in order to~     optimise auditory performance in the everyday lives of patients with implants by using an~     evolutionary algorithm.~   "
27824|NCT03202784|"~     This is an open-label, randomized study to investigate the relative bioavailability of two~     formulations of BCX7353 and to determine if there is a food effect~   "
27825|NCT03202771|"~     Test the Efficacy of Home Biofeedback Training: Currently, biofeedback requires a skilled~     therapist and sophisticated equipment and is not widely available. The investigators designed~     and tested a novel home biofeedback device and predict that home training will be as~     effective as office biofeedback therapy. Our specific aims are to perform a randomized~     controlled trial of 100 subjects with dyssynergic defecation to investigate:~      (A) Whether a self-administered, home-biofeedback training program with a new portable device~     is as effective as office-based biofeedback therapy in improving i) physiology- dyssynergia~     (defecation index), and ability to expel simulated stool, and ii) symptomatology-~     satisfaction with bowel function, number of complete spontaneous bowel movements, stool~     consistency, straining and quality of life.~      (B) Whether home-training is more cost-effective than office-based biofeedback training.~   "
27826|NCT03202758|"~     Colo-rectal cancer is still one of the leading causes of cancer death worldwide. In France,~     approximately 40 500 new cases are diagnosed each year. With more than 17 500 deaths in~     France in 2011, colo-rectal cancer is responsible for more than 12% of all cancer deaths, the~     overwhelming of deaths occurring in patients with metastatic disease.~      Many studies highlight the fact that colo-rectal cancer has immunogenic properties and that~     host immune responses can influence survival. Recent data have provided a clearer~     understanding of the factors limiting the antitumor immune response in colo-rectal cancer.~     One of the most critical checkpoint pathways responsible for mediating tumor-induced immune~     suppression is the programmed death-1 (PD-1) and PD ligand 1 (PD-L1) pathway.~      PD-1 is expressed on activated immune cells and can link to PD-L1 express on~     Antigen-Presenting-Cell. Usually, this pathway is involved in promoting T-cells tolerance and~     preventing tissue damage in settings of chronic inflammation. In pathological context, the~     PD-1/PD-L1 pathway contributes to immune suppression and evasion. Many human solid tumors~     including colo-rectal cancer express PD-L1, and this expression is associated with a worse~     prognosis. The interaction of PD-1 with the ligand PD-L1 inhibits T-cell proliferation,~     survival, and effectors functions; induces apoptosis of tumor-specific T cells; promotes the~     differentiation of CD4+ T cells into immunosuppressive regulatory T cells; and increases the~     resistance of tumor cells to cytotoxic T lymphocytes attack. Thus, the blockage of the~     PD-1/PD-L1 interactions represents a logical target for cancer immunotherapy and in~     particular colo rectal cancer immunotherapy strategy.~      Preclinical studies have shown that PD-L1 blockade improves the immune response by restoring~     T-cell effectors functions. Recent work in two in vivo tumor models shows a strong interest~     in using an anti-PD-L1 in combination with standard treatment of colo-rectal cancer (FOLFOX).~     In these models, the survival of mice that are treated with the combination therapy reached~     40% when no mice were alive with FOLFOX treatment alone. This result may be explained, in one~     hand by cytotoxicity of 5FU and in the other hand by the restoration of anti-tumor immune~     activity of anti-PD-L1. These results suggest that the combination of chemotherapy with~     immunotherapy would act synergistically in patients with colo-rectal cancer.~      Research Hypothesis: Combination of chemotherapy (FOLFOX) with immunotherapy association~     (anti-PD-L1 + anti-CTLA-4) would act synergistically in patients with colo-rectal cancer.~   "
27827|NCT03202745|"~     Inappropriate prescribing exposes patients to health risks and results in wasteful public~     expenditures. This study will evaluate an approach to fighting abusive prescription: sending~     letters to suspected potentially inappropriate prescribers warning them that they are~     outliers compared to their peers and have been flagged for review. The study will target high~     prescribers of opioids in the Schedule II controlled substances class. Two types of letters~     will be tested: one focusing on the health consequences of inappropriate prescribing for~     patients, and the other focusing on the consequences for prescribers including e.g. potential~     administrative actions. Using claims data, the investigators will assess the effect of the~     letters on prescribing of opioids, receipt of opioids by patients, substitution behavior by~     prescribers and patients, and health outcomes of patients.~   "
48198|NCT02936037|"~     The purpose of this study is to demonstrate the superiority of MD1003 over placebo in the~     disability of patients suffering from progressive multiple sclerosis and especially those~     with gait impairment.~   "
27828|NCT03202732|"~     The aim of this study is to investigate the effect of the use of DiabetesFlex in diabetes~     care compared to standard care in relation to patient involvement and relevance for specific~     group of persons with T1DM.~      The investigators hypothesize that the use of DiabetesFlex will lead to a higher degree of~     patient in-volvement, improved glycaemic control and a decrease in total number of~     consultations compared to standard care. Furthermore, the investigators aim to identify if a~     specific sub-population within the T1DM population will benefit significantly from the~     intervention.~   "
27829|NCT03202719|"~     This is an open-label randomized phase IV clinical trial assessing immunogenicity of~     poliovirus vaccines.Participants will be enrolled at 6 weeks of age and followed to 18 months~     of age. The study will recruit 1645 participants in five arms.~   "
27830|NCT03202706|"~     Obesity is associated with hyperactivation of the endocannabinoid system, and its inhibition~     by the administration of CB1 receptor (CB1R) antagonists, leads to a decrease in food intake,~     weight loss and an improvement in metabolic parameters. Even though the reduction in food~     intake following central CB1R inactivation seems to be the principal cause of weight loss and~     the improvement in metabolic parameters, several studies in animals and humans have indicated~     that peripheral CB1R could also be implicated in the regulation of glucolipid metabolism. As~     a result, it has been suggested that the long-term beneficial effects of inactivation of the~     endocannabinoid system are due to both central effects on food intake and peripheral effects~     involving adipose tissue, the liver, skeletal muscle and the pancreas. It appears essential~     to determine the role of CB1R located in peripheral tissues and in particular in adipose~     tissue, which plays an active role in maintaining glucolipid homeostasis. The experiments~     conducted in this project consist in studying in biopsies of abdominal subcutaneous fat~     whether activation of adipocyte CB1R modifies adipocyte metabolism by determining the~     mechanisms. The investigators hypothesize that activation of CB1R in adipose tissue will lead~     to the stimulation of lipolysis dependent on the alteration of the insulin signal, and~     therefore that inactivation of the endocannabinoid system by blocking peripheral CB1R could~     constitute a therapeutic approach to improve obesity-related insulin resistance and~     dyslipidaemia.~   "
27831|NCT03202693|"~     This study is a Phase 1, single-center, open-label, single-dose study to evaluate (1) the~     absorption, metabolism, and excretion patterns of a single dose of [14C] PA-824, and (2) the~     pharmacokinetics, safety, and tolerability of a single oral-suspension dose of unlabeled~     PA-824 in healthy adult male subjects. Unlabeled PA-824 and [14C]-PA-824 will be administered~     together in an oral-suspension formulation. Enrollment is planned for one dose group of 6~     subjects. All 6 subjects will receive the same treatment.~   "
27832|NCT03202680|"~     The objective of this trial is to compare the effects of a healthy, lean beef diet and an~     average American, United States Department of Agriculture (USDA) style diet, that is low in~     saturated fatty acids (SFA), on insulin sensitivity in men and women with risk factors for~     diabetes mellitus.~   "
27833|NCT03202667|"~     Syndrome of inappropriate antidiuresis (SIADH) is characterized by an imbalance of~     antidiuretic vasopressin (AVP) secretion. The impaired AVP regulation leads to water~     retention and secondary natriuresis and is a common cause for hyponatremia.~      Especially chronic (>72h) SIADH is difficult to treat as standard therapeutic options (water~     restriction, urea, salt tablets) often do not succeed in correction of hyponatremia, making~     additional therapy necessary.~      Empagliflozin is a sodium glucose co-transporter 2 (SGLT2)-inhibitor, which is a~     well-tolerated treatment option for type 2 diabetes mellitus. The inhibition of SGLT2 in the~     proximal tubule leads to renal excretion of glucose with subsequent osmotic diuresis. This~     mechanism could result in a therapeutic effect in patients with chronic SIADH, as it~     resembles the aquaretic effect of urea.~      The aim of this study is to evaluate whether empagliflozin has an effect on the serum sodium~     levels of patients with chronic SIADH.~   "
27834|NCT03202654|"~     The objectives of this trial are to assess the effects of corn oil and coconut oil on~     low-density lipoprotein cholesterol (LDL-C) concentrations, and other aspects of the fasting~     lipoprotein lipid profile, as well as insulin sensitivity and an inflammatory marker, in men~     and women.~   "
27835|NCT03202641|"~     The goal of this interventional crossover study, in intubated and mechanically ventilated~     Acute Respiratory Distress Syndrome (ARDS) patients, is to compare two positive~     end-expiratory pressure (PEEP) titration techniques regarding: respiratory mechanics, gas~     exchange, changes in aeration, ventilation/perfusion matching its impact on cardiac function,~     especially the right heart (RH). The PEEP titration techniques are: PEEP selection based on~     low PEEP/high FiO2 table (PEEPARDSnet) and lung recruitment maneuver (LRM) plus PEEP~     titration(PEEPLRM).~   "
27836|NCT03202628|"~     This phase II trial studies how well ixazomib citrate, pomalidomide, dexamethasone, and stem~     cell transplantation works in treating patients with multiple myeloma that has come back or~     does not respond to treatment. Giving chemotherapy, such as pomalidomide and dexamethasone,~     before a stem cell transplant helps kill any cancer cells that are in the body and helps make~     room in the patient?s bone marrow for new blood-forming cells (stem cells) to grow. After~     treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is~     then given to prepare the bone marrow for the stem cell transplant. The stem cells are then~     returned to the patient to replace the blood-forming cells that were destroyed by the~     chemotherapy. Giving ixazomib citrate in addition to pomalidomide, dexamethasone, and stem~     cell transplantation may work better in treating patients with relapsed or refractory~     multiple myeloma.~   "
27837|NCT03202615|"~     130 pregnant women with Iron deficiency anemia, in the 2nd trimester (microcytic hypochromic~     anemia, hemoglobin range from 9-10.5g/dl, serum ferritin less than 12 ng/ml), from the~     outpatient clinics in the Obstetrics and Gynecology Department, in Ain Shams University~     Hospital, Cairo, Egypt, will be enrolled and distributed into one of 2 groups by a computer~     generated random number table. Each of the 2 groups will receive 2 medication for 2 months~     with specific instruction to increase iron absorption. One group named L will receive powders~     of bovine lactoferrin and tablets of placebo form, the 2nd named F will receive ferrous~     sulphate tablet and placebo in powder form. Hemoglobin concentration, packed-cell volume~     (PCV) , mean cell volume (MCV), mean corpuscular hemoglobin (MCH), mean cell hemoglobin~     concentration (MCHC), Serum ferritin will be done at the start and the end of the treatment~     period.~   "
27838|NCT03202602|"~     Continuous positive airway pressure (CPAP) is the first choice of treatment for moderate to~     severe obstructive sleep apnea syndrome (OSAS). Although adherence is critical for achieving~     a good treatment effect, and early intervention if treatment problems emerge is important for~     achieving good adherence, information on patient compliance is usually based on assessment of~     the first few weeks of treatment. Telemedicine technology allows for monitoring of CPAP~     pressure, air leaks, apnea-hypopnea index (AHI) and compliance on a daily basis and could~     therefore be an option allowing for adequate support and quick response if a patient has~     problems with the treatment. In addition, improving early experiences of CPAP, identifying~     patients in need of more intensive support could potentially improve adherence but also~     reduced cost of care, and increased patient satisfaction.~      The proposed study will recruit 200 OSAS patients starting CPAP treatment; 100 patients~     randomized to afterwards receiving telemonitoring in combination with telephone calls, and~     100 patients randomized to receiving usual office visits. All patients will in addition~     answer questionnaires on sleep and health, quality of life, and patient satisfaction after~     the first CPAP information visit and then again after 6 months of treatment. At time of~     follow-up all patients will also answer questionnaires on side effects of CPAP. Health~     economic variables will also be measured throughout the testing period.~      The study will provide valuable information regarding benefits of telemonitoring in clinical~     work with CPAP therapy. Implementation of telemedicine-based monitoring of CPAP therapy may~     be an important part of increasing adherence among patients but also in the development of a~     more cost-effective care as it can provide clinics with increased treatment capacity and~     follow-up of both new and established patients. It would further improve the care for these~     patients who often have a lifelong treatment, which aims to reduce the risk of developing~     cardiovascular disease or premature death.~   "
27839|NCT03202589|"~     Hip fracture is the second indication of surgical management elderly patients. It remains~     linked with a one-year mortality of 20%-25% according to diiferent governmental agencies, and~     the incidence reaches 30% for those over 80 years old.~      The factors recognized and found to be most correlated with the survival / mortality ratio of~     patients are age, sex, intervention time, and prior health status.~      The aim of a preoperative clinical evaluation is to estimate the benefit-risk balance of~     different clinical and technical managements and to prepare the postoperative patient~     outcome. During the last decade, management of hip fracture has improved mainly due to the~     different recommendations for a multidisciplinary management of perioperative procedures.~     However, none of them have yet highlighted FOCUS echocardiography as a routine examination~     of the preoperative evaluation as in most noncardiac surgeries.~      The objective of this study is to evaluate the preoperative management of these patients:~     Clinical and biological evaluation, and to analyze the place that would have the FOCUS~     preoperative echocardiography in the choice of the anesthesia technique resulting from the~     patient evaluation.That study in a pre-requisite study to evaluate the incidence of FOCUS~     echocardiography realized by anesthesiologists in the preoperative period in order to define~     patient's outcome and anesthetic management.~   "
27840|NCT03202576|"~     This study evaluates the use of tape to secure nasogastric tubes compared to securement with~     a nasal bridle device.~   "
27841|NCT03202563|"~     The objective of this study is to evaluate the efficacy on glycemic variability and safety of~     gemigliptin 50 mg orally administered once daily for 12 weeks compared with Dapagliflozin~     10mg in patients with type 2 diabetes mellitus who have inadequate glycemic control on~     metformin alone or diabetes medication naïve patient~   "
27842|NCT03202550|"~     This will be a randomized, double-blind, placebo-controlled trial involving 2 arms. It will~     be comparing the effects of placebo compared to 1 mg oral lorazepam/5 mg oral oxycodone on~     pain scores during cervical dilator placement prior to dilation and evacuation (D&E).~   "
27843|NCT03202537|"~     The prevalence of gastroesophageal reflux disease is estimated to be as high as 20% in the~     United States, and up to 50% of these patients remain symptomatic on proton pump inhibitor~     (PPI) therapy. Unfortunately, the clinical approach to understand the mechanism of~     nonresponse is not standardized, and patients will often undergo various esophageal function~     tests: 1) pH-impedance, 2) wireless pH monitoring over 96 hours, 3) high-resolution impedance~     manometry (HRIM), and 4) mucosal impedance. Currently significant controversy exists~     regarding the best technique, optimal study protocol and treatment approach for the PPI~     non-responder (PPINR) group, resulting in inappropriate resource utilization and a failure to~     provide effective personalized care. As such, PPINRs contribute to a large healthcare burden~     in the United States.~      The first aim of the study is to identify the relevant physiologic parameters of the~     aforementioned diagnostic tools in their ability to predict PPI requirement. Subsequently, in~     Aim Two, these results will be applied to guide the formal development of a clinical~     algorithm for the management of PPINRs with personalized clinical pathways based on mechanism~     of treatment failure.~      The investigators will first perform a prospective comparison trial of 240 PPINR subjects at~     two centers over a 4 year period. Subjects will complete symptom questionnaires and undergo~     diagnostic testing (pH-impedance on PPI therapy, HRIM, 96-hthe wireless pH monitoring off of~     PPI therapy and mucosal impedance). Those who have a positive pH study and/or resume PPI~     therapy will receive escalation of acid suppression therapy with dexlansoprazole. Experiments~     1a & 1b will compare the ability of 96-hthe wireless pH monitoring vs pH impedance to predict~     PPI requirement and response to dexlansoprazole, respectively. Experiment 1c will explore~     whether mucosal impedance is equivalent to 96-hthe wireless pH monitoring in predicting PPI~     requirement. Lastly, Experiment 1d will determine whether HRIM metrics can be utilized to~     determine reflux burden, mechanism and response to treatment. Next, the investigators will~     develop quality measures for reflux testing in order to develop a simplified management~     strategy for the PPINR group. The RAND/UCLA Appropriateness Methodology will be utilized with~     an expert working group to develop formal validated quality measures for reflux testing based~     on results from aim 1 in addition to the available literature & evidence. This will be~     conducted over twelve months (years 4 to 5).~   "
27844|NCT03202524|"~     Large volume paracentesis with albumin administration is the standard of care for patients~     with refractory ascites complicating end-stage liver disease. However, the use of albumin is~     frequently limited due to expense and occasional short supply. The goal of this study is to~     demonstrate if the administration of fresh frozen plasma (FFP) is as effective as albumin for~     volume expansion at the time of a large volume paracentesis.~   "
27845|NCT03202511|"~     The study will be a randomized, open-label, cross-over clinical pharmacokinetic trial to~     investigate a strategy for probenecid boosting in the setting of tenofovir disoproxil~     fumarate (TDF)/emtricitabine (FTC) for HIV pre-exposure prophylaxis (PrEP). The study will be~     conducted at the Indiana University Clinical Research Center. All samples will be processed~     and the amount of tenofovir/FTC in plasma, blood, and urine, and tenofovir diphosphate and~     emtricitabine in peripheral blood mononuclear cells will be determined using validated~     analytical methods developed by the investigators at the University of Colorado. Probenecid~     plasma and urine concentrations will also be measured using an in-house assay. Following~     completion of the study, the secondary aim will be accomplished via analysis of selected~     samples collected at baseline and following treatment. Those selected samples will be~     assessed for urinary markers of proximal tubulopathy (urine total protein, albumin,~     creatinine, phosphorus, retinol binding protein, and beta-2-microglobulin) and serum alkaline~     phosphatase, osteocalcin, procollagen type 1 N propeptide, cystatin C, and creatinine to~     determine if the probenecid boosting strategy does indeed lead to less potential renal and~     bone toxicity.~   "
27859|NCT03202329|"~     Patients with heart failure NYHA >= II receiving non-emergent non-cardiac in-patient surgery~     will be randomized to receive either standard post-operative care (surgeon has to ask~     actively for specialist cardiological support) or a nurse-based heart failure management~     (nurses provide week-day support every day after surgery, if needed together with a heart~     failure doctor)~   "
27846|NCT03202498|"~     In patients with cirrhosis (scarring of the liver), bacterial fragments leak from the gut~     into the blood and cause harm. This study looks into a new way to lower the leakage of~     bacterial fragments into the blood.~      Yaq-001 is a new type of carbon that in previous laboratory studies has been shown to have~     the ability to bind these bacterial fragments and so confine them to the gut. The purpose of~     this clinical trial is to test the product Yaq-001 for the first time in patients with~     cirrhosis.~      This trial will assess if the treatment with Yaq-001 is safe, is well tolerated, and if it~     helps improve the overall health status of the cirrhotic patients.~      Candidate patients must be at least 18 years old and have a clinical diagnosis of cirrhosis~     for any cause. Only postmenopausal women or with surgical sterilisation are eligible.~     Additional inclusion and exclusion criteria of medical nature will be determined with the~     investigator at the screening visit, by means of standard care routines plus an additional~     test to assess the bowel transit time.~      Eligible patients will be randomly grouped to receive standard care treatment plus Yaq-001,~     or standard treatment plus placebo (non-active treatment). The use of placebo is necessary to~     better understand how safe and tolerable Yaq-001 really is.~      The treatment lasts for 12 weeks. During treatment, the patient will be visited by a study~     doctor 5 times. At all the visits the patients will undergo a routine physical examination,~     electrocardiogram, collection of blood and urine samples. On three occasions the patients~     will be asked to provide additional samples of blood, urine and stool for analysis outside~     the hospital.~      56 patients from 9 hospitals in UK, France, Italy, Portugal, Spain and Switzerland will~     participate in this study.~   "
27847|NCT03202485|"~     To compare the outcomes of a toric Implantable Collamer Lens (ICL) and a spherical~     Implantable Collamer Lens combined with astigmatic keratotomy (AK) in the correction of high~     myopic astigmatism.~   "
27848|NCT03202472|"~     This pilot clinical trial studies radiofrequency technology in locating non-palpable breast~     lesions in patients undergoing surgery. Placing a miniature radiofrequency tag or microchip~     in the breast lesion before surgery and using a handheld device to guide doctors during~     surgery may improve surgical outcomes in patients with non-palpable breast lesions.~   "
27849|NCT03202459|"~     Postoperative nausea and vomiting (PONV) is one of the most commonly reported adverse effects~     of anesthesia. The general incidence of vomiting is approximately 30%, nausea at 50% and the~     PONV rate can go up to 80% in high-risk patients without prophylaxis. Prevention of these~     episodes in high-risk patients improves satisfaction and well-being rates. Therefore, it~     becomes important the adequate control of PONV, aiming at the satisfaction of the patient~     with the procedure, lower costs for the health system as well as reduction of complications~     in the postoperative period. This study aims to evaluate the association of gabapentin or~     pregabalin with dexamethasone in reducing the incidence of PONV in high-risk patients~     undergoing laparoscopic surgeries in the first 48 hours postoperatively as well as to assess~     side effects.~   "
27850|NCT03202446|"~     Our study evaluates the use of Laser-Assisted Immunotherapy (LIT) plus placebo and LIT plus~     low-dose cyclophosphamide versus that of Standard of Care in patients presenting with Stage~     IIIA, IIIB or IV breast cancer.~      One-third of enrolled patients will receive LIT plus placebo, one-third will receive LIT plus~     low-dose cyclophosphamide, and one-third will be assigned to a control group that receives~     Standard of Care.~   "
27851|NCT03202433|"~     Reduce stress associated with needle aspiration, in voluntary and replacement blood donors.~      This study has not been completed.~   "
27852|NCT03202420|"~     The purpose of this pilot proposal are the following: 1) to determine the feasibility and~     acceptability of integrating the TOPS weight loss program into underserved populations~     through an urban safety net clinic and 2) to gather preliminary data of weight change to~     inform the design of a future randomized, controlled trial to determine the efficacy of the~     TOPS program in safety net clinics.~      To achieve these goals, the investigators will pursue the following Specific Aims:~      Specific Aim 1. Assess the feasibility and acceptability of integrating the TOPS program into~     an urban safety net clinic, with process measures (i.e., recruitment/refusal rates and~     retention/dropout rates) and focus groups.~      Hypothesis 1. Integrating the TOPS program into an urban safety net clinic is feasible and~     acceptable to participants.~      Specific Aim 2. Assess the percent of participants in the TOPS intervention arm with~     clinically significant weight change (i.e., weight loss of ≥5% of initial body weight) at 12,~     26, and 52 weeks.~      Hypothesis 2. 10%, 25%, and 33% of participants in the TOPS intervention arm will lose ≥5% of~     initial body weight at 12, 26, and 52 weeks, respectively.~   "
27853|NCT03202407|"~     Chronic Kidney Disease-Mineral and Bone Disorder  is a systemic disorder of mineral and~     bone metabolism, due to chronic kidney disease that is manifested by either one or a~     combination of the following :~        1. Abnormalities of calcium, phosphate, parathyroid hormone or vitamin D metabolism~        2. Vascular and/or soft tissue calcification.~        3. Abnormalities in bone turnover, metabolism, volume, linear growth or strength. According~          to glomerular filtration rate , Kidney Disease Improving Global Outcomesclassify chronic~          kidney disease into 5 stages,stage 5 also known as End Stage Renal disease is defined as~          glomerular filtration rate less than 15 ml/Min/1.73 m2, or the need for renal~          replacement therapy for survival The kidney plays a major role in phosphate~          homoeostasis. The kidneys excrete the total net amount of absorbed phosphate.Under~          normal physiological condition phosphate is freely filtered through the glomerulus. The~          majority (85-90%) of filtered phosphate undergoes tubular reabsorption primarily in~          proximal tubules.~      Progressive renal insufficiency leads to hyperphosphatemia, hypocalcemia, and secondary~     hyperparathyroidism .~      Hyperphosphatemia known as hidden killer in chronic kidney disease defined as an abnormally~     high serum phosphate concentration of >1.46 mmol/L (4.5 mg/dL). Its long term complications~     are renal osteodystrophy, hyperparathyroidism, and increased cardiovascular calcification~     leading to increased mortality and morbidity .~      High serum phosphate can interact with calcium to precipitate calcium phosphate salts in~     non-skeletal tissues Calcification generally occurs in the blood vessels, heart valves,~     myocardium, and other soft tissues .~      Cardiovascular calcification is probably the main reason for the high prevalence of~     cardiovascular diseases in chronic kidney disease patients Studies have shown that~     hyperphosphatemia is associated with increased vascular stiffening and arterial and valvular~     calcification This is postulated to be caused by elevated serum phosphorus promoting the~     transformation of vascular smooth muscle cells into an osteoblast phenotype that can~     mineralize These vascular calcification also lead to left ventricular hypertrophy by~     decreasing vascular compliance . Poor control of mineral metabolism also has been associated~     with functional and structural cardiac abnormalities Efforts to reduce morbidity and~     mortality associated with Chronic Kidney Disease-Mineral and Bone Disorder are therefore~     primarily directed at controlling hyperphosphatemia via diet, phosphorus binders, and~     dialysis~      Dialysis alone is inadequate in assisting hemodialysis patients to obtain and maintain normal~     serum phosphate levels . So, other methods of achieving prescribed levels of serum phosphate~     in hemodialysis patients include the use of phosphate binders and phosphorus dietary~     restrictions.:~      Phosphate binders have been approved by the Federal Drug Administration (FDA) for patients~     treated with maintenance dialysis, and calcium-containing salts are used worldwide not only~     for the control of hyperphosphatemia but also as a source of supplemental calcium. Several~     calcium salts are commercially available, including calcium carbonate, calcium acetate, and~     calcium citrate Sevelamer hydrochloride is a recently developed phosphate binder, which is a~     quaternary amine anion exchanger without calcium or aluminum. Sevelamer is effective in~     controlling hyperphosphatemia without increasing the calcium load in chronic hemodialysis~     patients In addition to its effects on serum phosphorous levels, sevelamer has been shown to~     decrease total serum cholesterol and low-density lipoprotein cholesterol and to increase~     high-density lipoprotein levels . These effects may offer additional benefits in reducing~     cardiovascular complications in patients with end-stage renal disease.~      Controlling abnormal laboratory parameters such as calcium ,phosphate and parathyroid hormone~     as well as preventing the progression of extraskeletal calcification is considered a major~     component for prevention of the bone disease and other related morbidities and hopefully~     mortality in chronic kidney disease patients~   "
27854|NCT03202394|"~     This Phase IIa pilot study is a placebo controlled, multicenter study to evaluate safety and~     efficacy of aerosolized BIO-11006 Inhalation Solution in ARDS patients. The subjects will be~     randomized 1:1 to either BIO-11006 125 mg twice daily plus standard of care or placebo plus~     standard of care. The treatment will continue for up to 28 days. The study will enroll up to~     60 adult ARDS patients in up to eight sites within USA.~   "
27855|NCT03202381|"~     The aim of this phase IV interventional study is to evaluate variation in bone mineral~     density and lean and fat body composition in patients with prostate cancer without bone~     metastasis, treated with Degarelix. These variations are evaluated at time 0 (before starting~     androgen deprivation therapy with Degarelix) and after 12 months of therapy by dual-energy~     X-ray absorptiometry (DXA scan).~   "
27856|NCT03202368|"~     This is a multicenter, interventional, open-label, long-term extension study of Study WA28119~     (NCT01791153) to evaluate the long-term safety of SC tocilizumab in participants with GCA who~     subsequently have flare or persisting disease activity. A maximum of 11 participants from six~     centers in France that participated in the WA28119 study will be enrolled. The entire study~     duration is anticipated to be approximately 160 weeks.~   "
27857|NCT03202355|"~     The aim of this study is to determine efficacy of OrthoPulse photobiomodulation on the rate~     of tooth movement during alignment for Subjects receiving fixed appliance orthodontic~     treatment.~   "
27858|NCT03202342|"~     The study will consist of five occasions with one week in between. BOLD signal intensity of~     the hypothalamus will be measured using fMRI. Measurements will be done before and after~     drinking 300 ml plain water or water to which glucose and/or ethyl butyrate will be added.~   "
27957|NCT03201042|"~     To establish performance of individual tests and combinations of tests (serological,~     molecular and cellular tests) in early Lyme infection diagnosis~   "
27860|NCT03202316|"~     The goal of this clinical research study is to learn if the combination of atezolizumab,~     cobimetinib, and eribulin (ACE) can help to control inflammatory breast cancer that is~     metastatic (has spread). The safety of this drug combination will also be studied.~      This is an investigational study. Atezolizumab is FDA approved and commercially available for~     the treatment of patients with locally advanced or metastatic urothelial carcinoma and~     patients with metastatic non-small cell lung cancer. Cobimetinib is FDA approved and~     commercially available for the treatment of patients with unresectable (cannot be removed~     with surgery) or metastatic melanoma. Eribulin is FDA approved and commercially available for~     the treatment of patients with metastatic breast cancer.~      The combination of atezolizumab, cobimetinib and eribulin for the treatment of metastatic~     inflammatory breast cancer is considered investigational. The study doctor can explain how~     the study drugs are designed to work.~      Up to 33 participants will be enrolled in this study. All will take part at MD Anderson.~   "
27861|NCT03202303|"~     This trial aims to study the efficacy and safety of cannabidivarin (CBDV) in children with~     ASD.~   "
27862|NCT03202290|"~     The prevalence of people suffering from gambling disorder is relatively high, and the impact~     on this disorder the individual and those around him is considerable. The etiopathogenic~     model of gambling disorder is multifactorial, involving various risk and vulnerability~     factors, involved in the initiation and maintenance of the disorder. Among these factors,~     neurocognitive alterations associated with the disorder has recently aroused interest among~     researchers. In this study, the investigators propose to explore the neurocognitive~     impairments of patients suffering from gambling disorder compared to a control group, in~     order to identify alterations that could be the target of cognitive remediation programs.~     Gambling disorder provides a unique opportunity to study the specific neurocognitive~     impairments of the addictive process because it is not biased by the neurotoxic effect of~     substances as it is the case in substance use disorders.~   "
27863|NCT03202277|"~     Type 2 diabetes (T2D) is a national epidemic and current lifestyle programs and medications~     are not effectively managing the crisis. This project aims to test a novel~     smartphone-delivered intervention that simultaneously targets multiple health behaviors~     (i.e., sleep, sedentary behavior, physical activity,dietary intake) within clinical settings~     at a large Veteran Health Administration regional hospital. If effective, this project has~     potential for large-scale implementation nationwide through the VA healthcare system and~     broad applicability for other populations at T2D risk as well as other disorders.~   "
27864|NCT03202264|"~     Medication side effects and interactions between medications are very common in older adults~     and are related to negative health outcomes, including mobility. In this study, the~     investigators will test a new process aimed at reducing unnecessary medication use and drug~     side effects in seniors using the best medical evidence and patient preferences for~     treatment. This study will assess how feasible the implementation of this intervention is~     within a long-term care facility as well as if it is possible. The study will also assess for~     any signals of reversal of medications related mobility impairments to reduce~     medications-related mobility impairment (fatigue, pain, falls) using the intervention.~     Participants in two long-term care facilities will participate in this study. Measures will~     include feasibility outcomes regarding the logistics of the intervention as well as patients~     outcomes (falls, hospitalizations, and medications) collected before and after~     implementation. Findings will inform the design of a randomized controlled trial to test the~     effect of this intervention on health outcomes.~   "
27865|NCT03202251|"~     Deep brain stimulation (DBS) is a neurosurgical procedure using a device that improves motor~     symptoms of specific neurological and movement disorders such as Parkinson's disease or~     Essential Tremor. As part of the patient's care, the DBS is implanted when symptoms cannot be~     satisfactorily controlled with medications or conventional therapies. Lower urinary tract~     symptoms are common in patients who have underlying neurological or movement disorders and~     control over lower urinary tract function is poorly understood. In this study we are~     evaluating the effects of DBS on lower urinary tract function.~   "
27866|NCT03202238|"~     Venepuncture can be challenging, especially in patients with co-morbidities that predispose~     them to have inaccessible veins. Multiple unsuccessful venepuncture attempts compromise~     patient care. It causes pain, delays in obtaining blood samples for investigations and~     instituting intra-venous treatment.~      Venepuncture assistive devices (VAD) include ultrasonography, and devices that utilize~     infra-red or transillumination. These are expensive, not widely available, and have not been~     rigorously proven to be effective. This preliminary study using an ordinary pen-torch for~     transillumination showed promising results. 95% of patients with known difficult venous~     access required two or less attempts for successful cannulation. It costs 35 times cheaper~     compared to the cheapest VAD in the market. The concept is promising but the technique~     cumbersome.~      Building upon the concept of transillumination, the aim of this study is to develop an~     idiot-proof cost-effective pocket-sized VAD (FireFly) to improve venepuncture success. A~     randomized controlled trial (RCT) will be conducted to determine its safety and efficacy. Two~     candidate prototypes will be modelled using Computer-Aided Design (Inventor®, Autodesk®,~     California, USA) and fabricated using 3D-printing. Each prototype will be fitted with~     light-emitting diodes of a specific wavelength (6500Knm, 4500Knm, or 660nm). Compared to~     existing VADs, FireFly will be significantly smaller and lighter. It will be constructed~     using nylon-based polyamide and silicone, with flexible circuitry. Flexibility allows it to~     conform to the patients' limbs. A large transverse viewing window optimizes vein~     visualization.~      We include adult patients aged 21 to 100 with difficult venous access (history of ≥3~     consecutive attempts required for successful cannulation during the current admission)~     requiring non-emergent venepuncture in the RCT. Each patient undergoes venepuncture over the~     upper-limb using one of the following: Veinlite® EMS (TransLite®, Texas, USA) (Control), a~     commercial transillumination device; Prototype-1; Prototype-2; Conventional venepuncture~     without an assistive device. Outcome measures include: successful cannulation within 2~     attempts; duration of venepuncture; subjective user feedback. Fisher's exact and~     Kruskal-Wallis tests will be performed.~   "
27867|NCT03202225|"~     While performing a primary TKA in consecutive patients, a constrained insert may be necessary~     when adequate stability and soft tissue balance are not obtained. In this retrospective~     study, The investigators aim to identify the prevalence and risk factors that associate with~     the use of a constrained insert in primary TKA.~   "
27868|NCT03202212|"~     On line haemodiafiltration (OL-HDF) has been shown to improve intra-dialytic hemodynamics and~     cardiovascular outcomes. Several potential candidates of these beneficial effects have been~     explored. The aim of this study was to investigate the impact of mixed OL-HDF (mOL-HDF) on~     different circulating mediators of vascular dysfunction.~   "
27869|NCT03202199|"~     The aim of this study was to assess the diagnostic accuracy of PET-MRI to predict~     resectability of pancreatic adenocarcinoma after neoadjuvant chemotherapy ± radiation~     therapy.~   "
27870|NCT03202186|"~     The primary objective of the clinical trial is to demonstrate superiority of BHR401 (oral~     micronized progesterone) versus placebo as a monotherapy for moderate to severe VMS in~     postmenopausal women. Three different doses of BHR-401 (200 mg, 300 mg or 400 mg) will be~     tested against placebo in hierarchical order, starting with the highest dose. Superiority~     will be defined as a significant (significance level α = 0.05) reduction of moderate to~     severe VMS frequency compared to placebo at treatment week 12 (the primary efficacy endpoint~     of the study).~   "
27871|NCT03202173|"~     To evaluate the use of probe-based confocal laser endomicroscopy (pCLE) in human~     nasopharyngeal mucosa for the differentiation of the nasopharyngeal squamous cell carcinomas.~   "
27872|NCT03202160|"~     Thyroid disorders are one of the most common endocrine problems in children and adolescents.~     Diagnostic considerations can be approached from the perspective of the goiter.A goiter, or~     thyromegaly, is an enlargement of the thyroid gland.Persons with enlarged thyroids can have~     normal function of the gland (euthyroidism), thyroid deficiency (hypothyroidism), or~     overproduction of the hormones (hyperthyroidism).~   "
27873|NCT03202147|"~     This is a Phase II, randomized, double-blinded, placebo-controlled study for subjects with~     evidence of PSCI.~   "
27874|NCT03202134|"~     Patients get a general anesthesia for DIEPFLAP surgery. Depending on the attending~     anesthesiologist an opioid based or an opioid free anesthesia is chosen. no randomization, no~     blinding is done.~      Retrospective outcome data are analyzed to improve further clinical care.~   "
27875|NCT03202121|"~     To analyze the relationship of nocturnal concentrations of melatonin, γ-aminobutyric acid and~     total antioxidants with insomnia after stroke.~   "
27876|NCT03202108|"~     Acceptability study to evaluate the gastrointestinal tolerance, palatability and participant~     compliance, over a 7-day period, of Krio for the dietary management of participants with~     intractable epilepsy or Glut-1 DS patients on a ketogenic diet.~   "
27877|NCT03202095|"~     The investigators hypothesize that the administration of a widely available, naturally~     occurring dietary supplement, creatine monohydrate, will reduce the severity of depression in~     individuals with type 2 diabetes. The purpose of this study is to determine whether 12 weeks~     of creatine supplementation is an effective treatment for depression in individuals with type~     2 diabetes.~   "
27878|NCT03202082|"~     The present study aims to expand the evidence base of neuropsychological services in the~     context of medical management of epilepsy, examining whether treatment outcome and patient~     satisfaction with medical care are significantly improved when neuropsychological evaluation~     is included as an additional component of medical care within a comprehensive epilepsy~     center. All participants will complete an initial survey and a follow-up survey regarding~     views towards their epilepsy treatment. Participants will be randomized into one of two~     groups. One group will be given a neuropsychological battery in addition to the survey. The~     primary study hypothesis is that the addition of neuropsychological services to~     treatment-as-usual will result in significant improvements in (a) satisfaction with medical~     care, (b) patient perceived treatment outcome, and (c) physician-rated medical compliance.~     The secondary hypothesis is that participants who undergo neuropsychological evaluation will~     be generally satisfied with their experience with neuropsychological services.~   "
27879|NCT03202069|"~     The purpose of this study is to determine the effects of daily protein intake patterns on~     body composition and eating behaviors during weight loss.~   "
27880|NCT03202056|"~     Dry needling is a new treatment technique, addressed to mechanical pain of the~     neuromusculoskeletal system. Recent investigations has developed new hypothesis about the~     etiology of the osteoarthritis and could be in relation to musculoskeletal disorders, but~     there is no published studies evaluating the results of this technique in hip osteoarthritis~     patients.~      The objective of this trial is to evaluate if dry needling is more effective in symptoms,~     function, range of motion, strength, muscular length, pain threshold and compared to sham dry~     needling and control.~      For this purpose the investigators conduct a randomized controlled trial double-blind~     (patient and examiner). The investigators included patients diagnosed of hip osteoarthritis~     Grade I-III by Scale of Kellgren and Lawrence.~      Patients included are randomized into 3 groups one receive Dry needling, other sham dry~     needling and the other is a control. Groups receive 3 treatment sessions.~      The variables are measured at the beginning and end of treatment. And also some variables are~     measured before and after each session. Patients who participated in sham dry needling or~     control group, when the intervention finish the investigators will be given the opportunity~     to receive the actual technique.~   "
27881|NCT03202043|"~     This study is designed to see if drinking a tomato-based vegetable juice will increase skin~     carotenoids.~   "
27882|NCT03202030|"~     This randomised controlled trial compares the immediate dentoalveolar restoration and bovine~     demineralised bone in immediate implants placed in fresh sockets with buccal resorption. A~     total of 34 patients will be included and followed clinically and radiographically for 18~     months. Patient centred outcomes will also be evaluated.~   "
27883|NCT03202017|"~     The purpose of this study is to investigate the effects of two treatment techniques called~     Expiratory Muscle Strength Training (EMST) and Lung Volume Recruitment (LVR) on breathing,~     swallowing, speech, and cough function in persons with mild to moderate ALS. Half of the~     participants will do EMST alone, and the other half of the participants will do EMST and LVR.~   "
27884|NCT03202004|"~     This study will evaluate the efficacy and safety of GSK2894512 cream for the topical~     treatment of plaque psoriasis (psoriasis) with its vehicle cream. This is a randomized,~     double-blind, vehicle-controlled, parallel-group, multicenter study in adults with psoriasis.~     The aim of this study is to show superiority of GSK2894512 over vehicle by comparing their~     response rates. The study will consist of 3 periods: up to 4 weeks screening, 12 weeks~     blinded treatment, and 1 week post-treatment follow-up period. Subjects will apply randomized~     study treatment to all psoriasis lesions once daily for 12 weeks. Subjects will be stratified~     by Baseline physician global assessment (PGA) category (PGA score=2, PGA score >=3) at~     randomization. Approximately 120 subjects will be randomized into the study of which 80 will~     receive GSK2894512 1% cream and 40 will receive vehicle cream. Total duration of a subject's~     participation in the study will be approximately for 14 to 17 weeks.~   "
27885|NCT03201991|"~     The purpose of this study is to determine the muscle strength of a muscle in the thigh after~     12 weeks of home exercise.~   "
27886|NCT03201978|"~     GSK2894512 (trans-isomer) is a fully synthetic, non-steroidal anti-inflammatory agent. This~     study is being conducted to evaluate the PK, safety and tolerability of GSK2894512 cream, 1~     percent administered topically to healthy adult subjects. PK parameters obtained in this~     study will be used to support the design of future maximum use PK (MUPK) studies in subjects~     with atopic dermatitis (AD) and plaque psoriasis or psoriasis (PSO). This is a phase 1,~     randomized, double-blind, vehicle-controlled, 3-period, sequential, inpatient study consists~     of a Screening visit, 3 treatment periods and a follow-up visit. GSK2894512 cream, 1 percent~     (or matching vehicle) will be administered sequentially in the treatment periods. Period 1~     will include once daily repeated topical applications on approximately 5000 centimeter (cm)~     ^2 intact non-occluded skin area for 21 days. Period 2 will include once daily repeated~     topical applications on approximately 5000 cm^2 intact occluded skin area for 21 days. Period~     3 will include a single topical application on up to 400 cm^2 gently taped-stripped skin~     area. Each treatment regimen will be followed by washout period for approximately 21 days,~     except for Treatment Period 3. Approximately 26 healthy adult subjects will be enrolled in to~     the study. Total duration of participation in this study will be approximately 18 weeks.~   "
27887|NCT03201965|"~     The purpose of this study is to evaluate the efficacy and safety of daratumumab plus~     cyclophosphamide, bortezomib and dexamethasone (CyBorD) compared with CyBorD alone in~     treatment of newly diagnosed amyloid light chain (AL) amyloidosis participants.~   "
27888|NCT03201952|"~     This project will evaluate distal intestinal bile salt administration in humans by deliving~     ursodeoxycholic acid (UDCA) into the terminal ileum of subjects with a pre-existing ileostomy~     and assessing several hormone levels following an oral glucose tolerance test compared to a~     placebo.~   "
27889|NCT03201939|"~     In this study, the Investigators plan to determine the optimal means to prevent or slow the~     progression of kidney disease among genetically at-risk northern Nigerian HIV-infected~     adults. Based on data from studies of diabetic kidney disease that used medications that~     block the renin angiotensin aldosterone system (RAAS), we plan to evaluate whether or not~     RAAS inhibition (using a widely available medication that blocks RAAS) in HIV-infected adults~     produces similarly promising results.~   "
27890|NCT03201926|"~     Malnutrition in cancer patients continues after surgery and worsens the patient's overall~     health and quality of life. Previous studies reported edible insects in patients' diets~     increased postoperative muscle mass and weight gain. Therefore, by using nutritionally~     excellent mealworms for a long time, it is proved that nutritional status and survival rate~     are improved, leading to development of various products of edible insects.~   "
27891|NCT03201913|"~     Phase1 study of TTC 352 for treatment of metastatic ER+ breast cancer.~   "
27892|NCT03201900|"~     This study is conducted to evaluate the seizure-free rate of the 26-week Maintenance Period~     in untreated participants with partial onset seizures (POS).~   "
27893|NCT03201887|"~     Performance Validity Tests (PVTs) are widely used for the detection of sub-optimal effort and~     malingering in neuropsychological assessments. Threats to their validity however likely to~     intensify with time (e.g., information available on the web or from legal representatives)~     and may lead to a decline in their ability to differentiate between malingerers and~     non-malingerers. Eye movements and response time (RT) are less obvious outcome measures and~     under less conscious control than more conventional PVT indices (e.g., accuracy). They are~     therefore promising measures that can aid in detecting malingering when used in conjunction~     with more conventional PVT indices. The Word Memory Test (WMT) is a widely used PVT in~     neuropsychological evaluations. As part of the proposed study, TBI patients, chronic pain~     patients and healthy adults (60 in each group) will be randomly divided to one of two~     conditions; optimal effort or sub-optimal effort (participants will be asked to play a TBI~     patient who wishes to present himself as having cognitive deficits or exaggerate existing~     cognitive deficits). The proposed study will improve the WMT's efficacy in detection of~     sub-optimal effort in neuropsychological evaluations and therefore protect its validity from~     future threats. In addition, the proposed study will provide us with better understanding of~     the effect of TBI on eye movements and RTs in general.~   "
27894|NCT03201874|"~     The project will test a tailored web and smartphone-based application (iCanCope with SCD) to~     improve pain self-management and functioning in youth (aged 12-18) with sickle cell disease.~     The program will include goal setting, peer-based social support, and pain self-management~     training. The investigators will determine initial program effectiveness through a pilot~     three-site randomized controlled trial in 160 youth randomized to treatment compared to~     attention control.~   "
27895|NCT03201861|"~     The investigators hypotheses that paclitaxel combined with cisplatin in a weekly-based~     regimen as adjuvant chemotherapy is more effective for high risk, HER2 negative breast cancer~     .~   "
27896|NCT03201848|"~     This is a multisite, double-blind, randomized, placebo-controlled, and parallel study~     designed to evaluate the clinical efficacy and safety of Huaiqihuang granule for treatment to~     children with chronic primary immune thrombocytopenia (Qi Yin deficiency).~   "
27897|NCT03201835|"~     The primary objective of the study was to evaluate the safety and tolerability of novel oral~     capsules containing THC and/or CBD, following a single administration to healthy volunteers.~     The secondary objective of the study was to compare the pharmacokinetic profiles of THC, THC~     metabolite 11-hydroxy-THC and/or CBD following a single administration of the investigational~     oral formulations with Sativex® Oromucosal Spray.~   "
27898|NCT03201822|"~     A randomized, double-masked and cross-over dietary intervention study in healthy young adult~     males to evaluate the concentration of F-derived metabolites in plasma and urine after single~     acute intakes of F-containing drinks on four different test days.~   "
27899|NCT03201809|"~     This study investigates the use of post-operative on-Q pain catheters for tissue expander~     based breast reconstruction, versus conventional ultrasound-guided blocks placed~     pre-operatively.~   "
27900|NCT03201796|"~     The aim of the study is to assess the efficacy and safety of prulifloxacin in comparison to~     levofloxacin in the treatment of patients affected by CBP.~   "
27984|NCT03200691|"~     The objective of this study is to evaluate the efficacy and safety of radiation therapy~     combined with anti-PD-1 antibody SHR-1210 followed by surgery in treating patients with~     resectable esophageal squamous cell carcinoma~   "
27901|NCT03201783|"~     Information regarding the optimal timing for frozen-thawed embryo transfer (FET) following a~     stimulated in vitro fertilization (IVF) is lacking. One option is to perform FET in the first~     cycle following the stimulated IVF cycle, i.e. immediate transfer. Another option is to~     postpone FET for at least one menstrual cycle, i.e. delayed transfer. This randomized study~     aims to compare the ongoing pregnancy rate of immediate versus delayed FET following a~     stimulated IVF cycle.~   "
27902|NCT03201770|"~     The study is to be performed in public health facilities in Central and West Africa where~     Pyramax will be used as treatment of uncomplicated malaria episodes, including repeat~     episodes. The study is to assess the safety of Pyramax, particularly in patients with~     underlying liver function abnormalities, in patients who have co-morbid conditions, such as~     HIV, and also in very small children (<1 year of age).~   "
27903|NCT03201757|"~     This study will evaluate the long-term safety, tolerability, and durability of treatment~     effect of ALKS 3831 in subjects with schizophrenia, schizophreniform disorder, or bipolar I~     disorder~   "
27904|NCT03201744|"~     The proposed study aims to assess the effect of different levels of muscle relaxation on the~     success of low-pressure insufflation, surgical conditions and patient recovery following~     laparoscopic repair of a ventral hernia (VHR) between 2 and 10cm in diameter. Patients will~     be randomized to moderate (TOF 1-2) or deep (post tetanic count 1-2) relaxation.~      Specific Aim 1. Compare two different modes of neuromuscular blockade (moderate and deep) on~     the ability to maintain low insufflation pressure during laparoscopic VHR. All procedures~     will start with low-pressure insufflation (8 mm Hg). Surgeon assessment of the conditions~     will be serially performed during surgery on an established visual scale. If conditions are~     deemed less than adequate (score 1-2), insufflation pressure will incrementally increase up~     to 15 mm Hg. Outcome for this specific aim will be the mean insufflation pressure during each~     procedure, and the ability to perform low-pressure laparoscopic VHR.~      Specific Aim 2. Evaluate the success of moderate neuromuscular blockade on the ability to~     maintain good conditions (visual scale grade 4 or 5) for each. Surgical conditions will be~     considered successful when scores are maintained at 4 or 5 throughout the duration of the~     procedure. Outcome for this aim will be the mean score for surgical condition assessment for~     each procedure, using a previously published surgeon-driven scoring system (score 4-5 will be~     used as a surrogate of good visualization).~      Specific Aim 3. Assess patient recovery with low and high insufflation pressures during~     laparoscopic VHR. Patient overall satisfaction with recovery, pain level, pain medication~     requirement, PONV incidence and severity will be assessed in multiple time points following~     surgery. Outcomes for this aim will be mean pain (visual scale), PONV severity (analogue~     score) and incidence (binary outcome), and patient satisfaction using the QoR-15 survey.~     Assessments will be performed at 30 minutes, 1, 12 and 24 hours following surgery.~   "
27905|NCT03201731|"~     Although psychotic disorders such as schizophrenia usually present in late adolescence or~     early adulthood, research suggests that a substantial subset of people are diagnosed for the~     first time after the age of 60. This condition is referred to as 'very late-onset~     schizophrenia-like psychosis' (VLOSLP). People with VLOSLP are thought to experience high~     levels of social isolation, yet there has been little research systematically examining this.~     Additionally, little is known about how lonely people with VLOSLP feel, or how this group~     relate to and perceive other people.~      This study aims to examine levels of social isolation and loneliness in patients with VLOSLP.~     The investigators also aim to explore aspects of social cognition in relation to VLOSLP.~      A case-control study design will be used to examine the relationship between VLOSLP,~     loneliness, social isolation and social cognition. The case group will be people diagnosed~     with a non-organic psychotic disorder after age 60. The comparison group will be those aged~     60 and above in contact with mental health services for a mental health difficulty, except~     from a psychotic disorder or dementia.~   "
27906|NCT03201718|"~     Post-marketing surveillance study to evaluate the real world safety and effectiveness of~     Viekira/ Exviera (paritaprevir/ritonavir/ombitasvir and dasabuvir) administered under a~     normal, routine treatment practice by Korean patients with Hepatitis C.~   "
27907|NCT03201705|"~     Spinal Cord Stimulation (SCS) has been a well-established treatment for chronic neuropathic~     pain in Failed Back Surgery Syndrome with associated legs and/or low back pain. The waves~     used in Spinal Cord Stimulation are mainly Tonic or Burst. Both Tonic and Burst stimulation~     offer neuropathic pain suppression, with slightly superiority of the Burst wave for the FBSS.~     The aim of our study is to evaluate the efficacy of a new stimulation paradigm with the~     combination of the two wave forms.~   "
27908|NCT03201692|"~     Balance and gait problems in subjects with neurological disease lead to reduced mobility,~     loss of independence and frequent falls. Treadmill training is a widely used form of~     treatment and it has been used in subjects with neurological disease to ameliorate walking~     and balance deficits. The Virtual Reality Treadmill as a therapeutic tool has been recently~     introduced to practice gait adaptability elicited by aligning foot placement relative to the~     projected visual context.~      Forty-eight subjects with neurological disease will receive treadmill training treatment~     randomly divided in Traditional Treadmill training and Virtual Reality Treadmill training.~      The aim of this randomized controlled study is to assess whether Treadmill training with~     Virtual Reality is better than Traditional Treadmill training in improving dynamic balance~     and cognitive aspects in subjects with neurological diseases.~   "
27909|NCT03201679|"~     The worldwide occurrence of hip fracture is high with an annual incidence of approximately~     100 per 100.000 people. Mortality for patients undergoing hip fracture surgery is high with a~     30-day mortality rate varying between 4.5 and 13.3 %. It is agreed that non-modifiable~     factors such as age, gender and pre-existing comorbidities contribute to early death of hip~     fracture patients. However, not many studies have focused on preoperative sepsis as a~     potential risk factor. Hip fracture patients are commonly identified with sepsis after~     surgery, but the extent of preoperative sepsis and its consequences are sparsely elucidated.~     Being able to identify patients at higher risk of postoperative mortality could potentially~     improve outcome and extensive hospital registries of vital signs and cultures allow~     identification of preoperative sepsis.~      The aim of this study is to assess the association between preoperative sepsis and the 30-day~     mortality after hip fracture surgery.~   "
27910|NCT03201666|"~     This diagnostic test is aimed to compare the Karyotyping, CMA and NIPT for prenatal~     diagnosing chromosomal anomalies. Pregnant women who needed prenatal genetic diagnosis meted~     the study criterion; fetal amniotic fluid was regular examined by Karyotyping and CMA, and~     maternal peripheral blood was collected for NIPT detecting. And the CMA result as a golden~     standard, the main outcome is compared the diagnostic efficacy of NIPT for diagnosing~     chromosomal anomalies.~   "
27985|NCT03200678|"~     An assessment of the effect of surgical anterior cruciate ligament (ACL) on thigh muscles is~     critical to the improvement of knee rehabilitation and preservation. However, if a large~     number of studies had rated surgical technics, giving high results level for ACL~     reconstruction (ACLR), muscle recovery is still conditioning functional success. Furthermore~     there is no consensus about criteria in return to sport.~      The aim of this exploratory study is to quantify the mechanisms of neuromuscular adaptation~     of muscle thigh after ACL surgery.~   "
27911|NCT03201653|"~     Overall morbidity rate remained high after distal pancreatectomy (DP), ranging from 30% to~     60%. Whilst postoperative pancreatic fistula (POPF) remains serious and also is one of the~     most common complications after DP (12% to 40%). POPF after DP is also associated with major~     complications such as bleeding or septic shock and remains an equivocal problem. However, all~     the previous reports were retrospective review, non-randomized study, or individual~     experience and showed no significant improvement of overall POPF. As always, this issue~     remains in obscurity and seek for a more concrete evidence to solve.~   "
27912|NCT03201640|"~     All of the tools currently available for preoperative preparation of children either use a~     third person approach (i.e., use media whereby they watch a video or look at pictures of~     another child receiving an anesthetic), provide tours at some time previous to the operation~     date, or are shown the equipment that they will encounter during their anesthetic. No~     preoperative programme currently allows the child to experience the entire chain of events~     from leaving the preoperative preparation area (and their parents), walking to the operating~     area, being initially prepared for and receiving anesthesia and recovering from anesthesia,~     in real time and from a first person perspective. As such the investigators are carrying out~     this study to assess whether virtual reality preoperative preparation is effective in~     reducing anxiety at induction of anesthesia.~   "
27913|NCT03201627|"~     This study is planned to study whether lithium carbonate has protective effect on the brain~     of Niemann-Pick disease type C1.~   "
27914|NCT03201601|"~     The aim of the present study is to evaluate the effect of increasing the proportion of~     D-chiro-inositol (DCI) in a combination with myo-inositol (MYO) in improving fertility in~     women with polycystic ovarian syndrome (PCOS). Sixty women diagnosed with PCOS will randomly~     take twice a day for 12 weeks a capsule containing 550 mg of myo-inositol and 150 mg of~     D-chiro-inositol or capsules containing 550 mg of myo-inositol and 13.8 mg of~     D-chiro-inositol.~   "
27915|NCT03201588|"~     The study is a Randomized Intervention, Multi-Center Study to Determine the Role of Fatty~     Acids in Serum and Breast Milk in preventing Retinopathy of Prematurity Subjects who meet all~     inclusion and none of the exclusion criteria will be enrolled into the study. Upon entry into~     the study, subjects will be randomized and given a unique subject number.~      A randomized intervention study of 105+105 (number based on power analysis regarding up to~     date ROP frequency, see 5.1 and 11.1) infants without major malformations born with a~     gestational age less than 28 weeks + 0 days will be performed.~   "
27916|NCT03201575|"~     Septic shock remains a major public health problem in industrialized countries, with a~     mortality rate as high as 50%, largely related to multiple organ dysfunction. In addition to~     dysregulated inflammatory response, the pathophysiology of organ failures in septic shock~     involves ischemia-reperfusion processes. Remote ischemic conditioning is a therapeutic~     strategy for protecting organs against the detrimental effects of ischemia-reperfusion~     injury.~      The objective of the present study is to determine whether remote ischemic conditioning can~     limit the severity of organ failure in patients with septic shock.~   "
27917|NCT03201562|"~     To evaluate the safety and efficacy of PRX-100 compared with aceclidine alone and vehicle in~     the treatment of early to moderate presbyopia.~   "
27918|NCT03201549|"~     The primary aim of this study is to examine the effect of fructose ingestion on serum FGF-21~     levels in humans.~   "
27919|NCT03201536|"~     Zipline incision approximation vs. Suture -- zips 3 study. A prospective, multi-site,~     non-blinded, randomized controlled, study designed to evaluate user preferences associated~     with use of the zipline 3 system versus conventional suturing for incision closure.~   "
27920|NCT03201523|"~     The purpose of this research study is to design, implement, and evaluate a community level,~     socio-ecological based CVD prevention intervention using a participatory approach for women~     in a homogeneous ultra-Orthodox Jewish Hasidic community in Israel. A quasi-experimental,~     pre-post study design will be utilized, where all community participants will be exposed to~     intervention components. Pre and post samples will be selected through randomized cluster~     sampling of pre-existing community groups. It is hypothesized that ultra-Orthodox Jewish~     Hasidic women exposed to this community intervention will have improved healthy eating~     behaviors, reduced unhealthy eating behaviors, increased engagement in physical activity and~     sleep, and reduced risk for obesity (weight, BMI).~   "
27921|NCT03201510|"~     This study aims to determine the feasibility of recruiting and retaining men who have sex~     with men (MSM) in a multi-country prospective cohort study in preparation for human~     immunodeficiency virus (HIV) prevention studies in sub-Saharan Africa (SSA).~   "
27922|NCT03201497|"~     the investigators aim to set up a multicenter registry study for severe PJP requiring ICU~     admission. The purpose of this study is~        1. to establish a prospective severe PJP registry about clinical characteristics,~          laboratory and radiographic findings, critical care management and outcomes.~        2. to explore the predictive factors associated with outcomes ;~        3. to compare the difference between PJP patients with HIV and without HIV infection.~   "
27923|NCT03201484|"~     A study correlating patient reported outcomes measured by a validated tool with physical~     measurements recorded by 3d photography of patients undergoing parotid resections~   "
27924|NCT03201471|"~     It's a prospective, single arm, open label phase II clinical trial, in which the safety and~     efficacy of Chidamide plus R-CHOP regimen is accessed in de novo DLBCL patients, who have~     received 2 courses of R-CHOP but only achieved PR or whose MRD tests for ctDNA revealed~     positive results.~      abbreviation: R-CHOP: the chemo-therapy regimen composed of Rituximab, cyclophosphoamide,~     etoposide, vincristine and prednisone.~      PR: partial remission; MRD:minimal residual disease;~   "
27925|NCT03201458|"~     This randomized phase II trial studies how well atezolizumab with or without cobimetinib~     works in treating patients with bile duct cancer that has spread to other places in the body~     and cannot be removed by surgery or gallbladder cancer. Monoclonal antibodies, such as~     atezolizumab, may interfere with the ability of tumor cells to grow and spread. Cobimetinib~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~     Giving atezolizumab with cobimetinib may work better at treating patients with bile duct and~     gallbladder cancer.~   "
27926|NCT03201445|"~     The primary objective of this study is to evaluate the testicular safety of filgotinib in~     adult males with moderately to severely active ulcerative colitis.~   "
27927|NCT03201432|"~     Stroke is one of the important causes of disability and death in the world, in which more~     than half were ischemic strokes. About 1/4 of the ischemic stroke occurred in the vertebral~     basilar artery system, especially when in the presence of extracranial proximal vertebral~     artery stenosis. Vertebral artery stenting is a minimally invasive method for the~     reconstruction of vertebral artery stenosis and the early clinical studies showed that it was~     feasible, safe and effective, but the high rate of restenosis has become a bottleneck~     restricting its development. Previous systematic review had suggested that the drug eluting~     stent might reduce the incidence of restenosis of vertebral artery. However, prospective~     randomized controlled trials comparing the efficacy of bare metal stents and drug eluting~     stents on the prevention of restenosis remains absent.~   "
27928|NCT03201419|"~     The purpose of this trial is to investigate the efficacy, safety and tolerability of~     different oral doses of FE 201836, with desmopressin as a benchmark, during 12 weeks of~     treatment for nocturia due to nocturnal polyuria in adults~   "
27929|NCT03201406|"~     During 1993 and 2006, a total of 987 patients older than 20 years underwent native kidney~     biopsy at the Renal Division of this hospital. 404 patients with membranoproliferative~     glomerulonephritis and mesangioproliferative glomerulonephritis, and patients with secondary~     glomerulonephritis or other renal pathologies, such as diabetic nephropathy, lupus nephritis,~     rapid progress glomerulonephritis, acute tubular necrosis, and tubulointerstitial nephritis~     will be analyzed. The demographic characteristics and laboratory data of these patients at~     presentation or before renal biopsy will be recorded. These data included parameters such as~     age, sex, diabetes, hypertension, immunosuppressants treatment, BUN, serum creatinine,~     albumin, hemoglobin, total cholesterol, triglycerides, and urine protein. All subjects will~     be followed until 2015 for occurrence of primary endpoints, including all-cause death or ESRD~     requiring long-term dialysis or renal transplantation. A total of 433 patients who had been~     followed for 3 years during 2003 and 2007 will receive regular clinic follow-up. GFR will be~     estimated according to the Modification of Diet in Renal Disease (MDRD) abbreviated formula:~     186 x Scr -1.154 x age -0.203 x 0.742 (if female). CKD stage will be determined as described~     by the National Kidney Foundation of the United States. At the time of entry, GFRs of 30-59,~     29-15 and < 15 ml/min/1.73 m2 for more than 3 months will be classified as CKD stages 3, 4~     and 5, respectively. Baseline Data of the 433 patients are used as recorded at the beginning~     during 2003 and 2007. The observation period of each patient is defined to start immediately~     after the registered measurement of serum creatinine satisfying the above criteria~     (designated as the index date) and lasted until ESRD or end of 2015. ESRD is defined as~     initiation of RRT, i.e. chronic dialysis or renal transplantation.~   "
27930|NCT03201393|"~     This proof-of-concept study evaluates ALLOD-2 for the treatment of chronic low back pain.~      The investigational product (ALLOD-2), is a combination of two marketed drugs. Both drugs are~     used at much lower doses than the doses used for the approved indications.~      The combination is a First-in-Class drug due to its new and unique mechanism of action.~   "
27931|NCT03201380|"~     The prostate cancer is a heterogeneous disease the care of which varies according to the~     status: localized, locally advanced, or in recurrence after local or metastatic treatment.~     The precise evaluation of the degree of extension of the disease is thus essential because it~     is going to allow to adapt at best the therapeutic strategy.~      Contrary to the abdomino-pelvic scanning and to the osseous scintigraphy which(who) are a~     member(part) of the balance assessment of standard extension of the prostate cancer, the~     place of the Tomography with broadcast of Positrons to scan (TEP scan) in Choline in the~     management of patients affected by prostate cancer is not clearly defined in the national and~     European recommendations.~      The current marketing authorization ( AMM) is the research for bones localizations in the~     prostatic cancers at high risk. It indeed seems that this examination is more successful than~     the standard radiological examinations (bone scintigraphy and abdomino-pelvic scanning) in~     the detection of the bone metastatic hurts, with a sensibility of about 100 % and a precision~     of the order of 93 % according to certain studies.~      The recent data of the literature suggest a quite particular interest at the patients in~     situation of biochemical recurrence in terms of localization of (or) tumoral site (s).~      THE AMM however not specifying if this examination has to be made within the framework of the~     initial balance sheet of extension, at the time of the biochemical second offense or at the~     known metastatic stage, there is a big variability of the practices according to the centers.~      The current indications being very ill-assorted, he is interesting being able to estimate the~     heterogeneousness of the practices of way multicentre, by leading a study observationally~     retrospective in region Provence-Alpes-Côte d'Azur (PACA).~   "
27932|NCT03201367|"~     Portal vein thrombosis (PVT) in patients with liver cirrhosis may be due to neoplastic growth~     or non-neoplastic causes.~        -  Treating PVT with anticoagulation in liver cirrhosis is difficult to be established but~          may be of great benefit in acute symptomatic PVT.~        -  The ultimate goal is complete recanalization of the portal vein without inducing major~          bleeding, abnormal liver function tests or increased mortality.~   "
27933|NCT03201354|"~     The Ex-PRESS Glaucoma Filtration Device is a small, non-valved implant that was designed to~     lower intraocular pressure (IOP) by shunting aqueous humor from the anterior chamber into the~     subconjunctival space. The implant was developed in response to the need for more~     straightforward, standardized and safe surgical technique than standard filtration surgery.~     No iridectomy and no sclerectomy is needed if an Ex-PRESS device is implanted under a~     partial-thickness scleral flap. This may reduce surgical time and complications when compared~     to a standard trabeculectomy.~      In some studies it has been found to be safe and effective with few complications, even in~     high-risk patients. No previous studies have compared filtration surgery with Ex-Press~     implant to deep sclerectomy.~   "
27934|NCT03201341|"~     To accurately control body movements to interact with objects, our brain needs~     representations of the body and the nearby space. The broader aim of this research project is~     to study the behavioural and physiological mechanisms involved in the constitution of these~     representations, to identify their neural bases, in order to better understand the~     dysfunctions in the context of neurological or developmental disorders.~   "
27935|NCT03201328|"~     This is a prospective research study talking place at University hospital of Dijon and~     requiring the inclusion of 20 healthy subjects, 10 patients with unilateral cochlear implants~     and 10 patients with bilateral cochlear implants to carry out:~        -  an audio-vestibular examination,~        -  a videonystagmoscopic study,~        -  a posturography study and~        -  a movement study. The aim of the study is to evaluate the impact of binaural audition on~          postural performance and orientation.~   "
27936|NCT03201315|"~     The aim of this quality control study is to describe the presence and intensity of~     postoperative nausea and vomiting (PONV) and its correlation with intraoperative fentanyl~     dosing. Additionally, the investigators will examine pain scores.~   "
27937|NCT03201302|"~     Bone mass develops throughout childhood and adolescence until a peak bone mass is achieved~     during early adulthood. Fracture risk later in life can be predicted at a large extent by~     peak bone mass. Occurence of sarcopenia and osteoporosis (i.e. loss of mone mass) during late~     adulthood has been strongly associated with the degree of bone mineralization during early~     life. Nearly 50% of total bone mineral content (BMC) reached during adulthood is obtained~     during pre-adolescence rendering this period critical for skeletal health and is considered~     as an optimal period for bone/skeletal growth since during this time bones are more adaptable~     to osteogenic stimuli such as exercise-induced mechanical loading. Organized sport activities~     and/or nutrition appear to affect profoundly bone mineral density (BMD), BMC, bone geometry,~     and overall skeletal health during preadolescence offering an effective type of prevention of~     osteoporosis, a condition very difficult to treat later in life. Evidence suggest that some~     modes of exercise activities may be more effective (osteogenic) for bone development due to~     the magnitude and type of mechanical strain placed on long bones causing them to be more~     dense. Weight-bearing activities (e.g. running, jumping etc.) are believed to be more~     osteogenic than non-weight bearing activities. However, more research is required in order to~     determine: i) whether weight-bearing activities are more osteogenic than non weight -bearing~     activities during childhood and ii) the osteogenic potential of a large number of sport~     activities used by school-children as compared to a control treatment of no participation in~     organized sport activities. The present trial attempted to compare a large number of~     different sport activities in respect to their osteogenic potential based on training~     variables that are thought to affect osteogenesis while at the same time allows direct~     comparison of exercise modes that are entirely different. Therefore, the goal of this~     investigation was to determine the osteogenic potential of a large number of exercise~     training activities in boys and girls of 8-12 years of age during an entire primary school~     season.~   "
27938|NCT03201289|"~     The purpose of this study is to measure MTWA in the patients undergoing cardiac surgery and~     to investigate the relation between MTWA and adverse clinical outcomes.~   "
27939|NCT03201276|"~     Glucosamine is an important part of the treatment strategy for osteoarthritis, but its~     effectiveness is still controversial. To explain the efficacy differences of glucosamine, in~     this study the investigators detect the concentration of glucosamine in the plasma and~     synovial fluid, some effect indexes such as inflammatory markers and gene polymorphism of~     glucosamine transporters. On the one hand, the investigators compare the plasma peak and~     gluten glucosamine concentration and the concentration in synovial fluid among participants~     to observe the individual differences of glucosamine exposure in vivo. On the other hand, the~     investigators investigate the correlation between drug concentrations, effect index and gene~     polymorphism. The hypothesis is that glucosamine exposure in vivo has individual differences~     and gene polymorphism can explain this differences.~   "
27940|NCT03201263|"~     Mortality of intubated acute hypoxemic respiratory failure (AHRF) and acute respiratory~     distress syndrome (ARDS) patients remains considerably high (around 40%) (Bellani 2016).~     Early implementation of a specific mechanical ventilation mode that enhances lung protection~     in patients with mild to moderate AHRF and ARDS on spontaneous breathing may have a~     tremendous impact on clinical practice.~      Previous studies showed that the addition of cyclic short recruitment maneuvers (Sigh) to~     assisted mechanical ventilation: improves oxygenation without increasing ventilation~     pressures and FiO2; decreases the tidal volumes by decreasing the patient's inspiratory~     drive; increases the EELV by regional alveolar recruitment; decreases regional heterogeneity~     of lung parenchyma; decreases patients' inspiratory efforts limiting transpulmonary pressure;~     improves regional compliances. Thus, physiologic studies generated the hypothesis that~     addition of Sigh to pressure support ventilation (PSV, the most common assisted mechanical~     ventilation mode) might decrease ventilation pressures and FiO2, and limit regional lung~     strain and stress through various synergic mechanisms potentially yielding decreased risk of~     VILI, faster weaning and improved clinical outcomes.~      The investigators conceived a pilot RCT to verify clinical feasibility of the addition of~     Sigh to PSV in comparison to standard PSV.~      The investigators will enrol 258 intubated spontaneously breathing patients with mild to~     moderate AHRF and ARDS admitted to the ICU.~      Patients will be randomized through an online automatic centralized and computerized system~     to the following study groups (1:1 ratio):~        -  PSV group: will be treated by protective PSV settings until day 28 or death or~          performance of spontaneous breathing trial (SBT);~        -  PSV+Sigh group: will be treated by protective PSV settings with the addition of Sigh~          until day 28 or death or performance of spontaneous breathing trial (SBT).~      Indications on ventilation settings, weaning, spontaneous breathing trial and rescue~     treatment will be specified.~   "
27941|NCT03201250|"~     In the currently proposed phase I/II study, the investigators aim to treat patients with~     relapsed and/or relapsed refractory Multiple Myeloma who have progressed on carfilzomib-based~     therapy with an FDA approved c-MET inhibitor, cabozantinib.~   "
27942|NCT03201237|"~     To compared short- and long-time action observation training (AOT) in terms of grip strength,~     the Jebsen Taylor Hand Function Test (JTHF), the Quality of Upper Extremities Skills Test~     (QUEST), and the ABILHAND-Kids test.~   "
27943|NCT03201224|"~     In the complex process of organ transplant, two of the major steps are:~        1. evaluation of the organs of potential donors in health institutions:~        2. proposing grafts to the transplant teams, according to rules defined at the national~          level.~      In the absence of the possibility of transmitting the images between the deceased donor sites~     and the transplant teams, the visualization of these examinations does not take part in the~     decision-making of the transplant team. This leads in the displacement of the transplant team~     in order to verify the grafts after acceptance of the graft proposal.~      The Cristal Image project is a visualisation project for the transplant teams, in real~     time, at the time of the proposal of the graft so that they can give an opinion (acceptance,~     refusal) in less than 20 minutes (legal delay for a vital organ) after analyzing the medical~     records provided and the imaging data (scanner, ultrasound (s), coronary angiography, etc.).~      The hypothesis of the project is that the implementation of a secure image transmission~     (complete anonymisation of the data of the donor) before the acceptance by the team, will~     allow an optimization of the use of the qualified organs by reducing risks, unnecessary~     displacement of transplant surgical teams, and securing the allocation of organs to recipient~     patients.~   "
27944|NCT03201211|"~     The purpose of this long-term follow-up of a Phase I study is to evaluate the kinetics of the~     antibody response to NTHi-Mcat antigens and long-term safety, in subjects aged between 50-71~     years at the time of enrolment in the NTHi-Mcat-001 study. These subjects were previously~     exposed to two adjuvanted formulations of the NTHi-Mcat vaccine administered according to a~     0, 2 months schedule in the NTHi-Mcat-001 (201281) study. The subjects that had received~     saline placebo controls will also be included in this follow-up study to make comparisons~     with the investigational vaccines. No vaccinations will be administered in this trial.~   "
27945|NCT03201198|"~     This study examines the effects of an exercise and behavioral program, called Active-Life, to~     promote physical activity in people with chronic obstructive pulmonary disease. A sedentary~     lifestyle is very common in older people with chronic disease and if this program is~     successful it will be used to promote physical activity and improve the health of people with~     chronic obstructive pulmonary disease.~   "
27946|NCT03201185|"~     The investigators aim to demonstrate that ramipril after transcatheter aortic valve~     implantation has benefits in terms of prognosis, cardiovascular events and ventricular~     remodeling (MRI).~   "
29132|NCT03185676|"~     The impact of a bilberry-based probiotic drink on the postprandial levels of serum glucose~     and insulin have already been study in the past. The aim of the current study is to evaluate~     the long term effect of the probiotic bilberry drink on glucose tolerance and insulin~     resistance in healthy adults and in comparison to a control drink.~   "
27947|NCT03201172|"~     The study is designed as a monocentric, prospective, observational, comparative follow-up~     study based on two previously treated patient groups. The first group consists of patients~     treated with the patient-specific unicondylar knee implant iUni®. For that group, 30 patients~     will be included in the study and analyzed. The final follow-up after 24 months has already~     been documented by the study center. Compared to that, a consecutive series of 50 Univation®~     X patients will be invited for a 24 months follow-up in 2018. In total, it is planned to~     include 80 retrospective patients for that historical control study design.~      The products under investigation were used in routine clinical practice and according to the~     authorized Instructions for Use (IfU). Those data that are obtained in routine clinical use~     will be documented in the Case Report Form (CRF).~   "
27948|NCT03201159|"~     The study drug (VLX103) is being developed for the treatment of Alcoholic Steatohepatitis and~     other liver diseases. Alcoholic Steatohepatitis is an inflammatory (associated with~     irritation, swelling and cell damage) disease that affects the liver. It is associated with~     heavy and chronic intake of alcohol and presence of fat in the liver. Signs and symptoms~     often include fever, yellowing of the skin, nausea and impairment of liver function.~      The main objective of this study is to evaluate the safety, pharmacodynamics (what the drug~     does to the body) and pharmacokinetics (how the drug is handled by the human body, like~     absorption and elimination) of increasing doses of VLX103 in subjects with moderate Alcoholic~     Steatohepatitis. In other words, we will evaluate how your body tolerates VLX103 at a~     specific dose and the effects that this VLX103 dose has on your liver and your body in~     general. The secondary objectives of this study are to evaluate if VLX103 has the potential~     to treat Alcoholic Steatohepatitis patients, to determine the maximum dose that can be~     tolerated, and to measure the levels of VLX103 in your blood at different time points during~     the study.~      VLX103 is an experimental drug. Experimental means that the drug has not been approved by the~     Food and Drug Administration (FDA) for the treatment of Alcoholic Steatohepatitis. The active~     ingredient in VLX103, pentamidine, is approved for treating parasitic (microorganisms)~     infections. Pentamidine is currently approved and marketed in about 20 countries, including~     the United States, for use by injection (administered by a syringe) and by inhalation~     (administered by a nebulizer) for other health conditions. However, VLX103 is the first oral~     form of pentamidine being developed, and is administered by mouth as an oral tablet.~   "
27949|NCT03201146|"~     The purpose of this study is to evaluate the safety and clinical activity of Apatinib in~     combination with AP(Pemetrexed/Carboplatin) or AC(Pemetrexed/Carboplatin) as first-line~     chemotherapy in subjects with advanced EGFR wild type non-squamous non-small cell lung~     cancer(NSCLC).~   "
27950|NCT03201133|"~     Patellofemoral pain syndrome (PFPS) is a multifactorial pathology characterized by diffuse~     retropatellar and peripatellar pain in the knee joint, exacerbated by overloading activities~     on the patellofemoral joint. However, this disease showed high degree of patients not~     responsive to therapeutic strategies. This condition occurred because several factors is~     related to disease such as: (1) proximal factors (involving trunk and hip), (2) local factors~     (surrounding and or within the patellofemoral joint) and (3) distal factors (involving ankle~     and foot). Thus, the identification of clinical subgroups based in anatomic changes~     (proximal, local and distal factors) is a recent strategy that could help in the therapeutic~     strategies focused on the etiology of the disease, improve responsiveness to treatment,~     clinical and functional benefits.~   "
27951|NCT03201120|"~     Phase 3b of the research will be a laboratory experiment that uses an experimental and~     analytic design that is parallel to that used in Phase 3a, the online experiment. The primary~     objective of Phase 3b is to assess physiological response (i.e., eye tracking) to different~     message appeals of the audio-visual messages used in Phase 3a on respondents' behavioral~     intentions and UV-related behavioral choices post-exposure. Including time for preparation,~     viewing, and removal of the monitoring equipment, the message viewing session will take about~     45 minutes per session.~   "
27952|NCT03201107|"~     To analyze the effects of a Pilates exercise program on obesity, sarcopenic, risk of falls~     and health in Spanish postmenopausal women~   "
27953|NCT03201094|"~     The study purpose is to investigate the hypothesis that in adults with SAH, early~     neuromuscular electrical stimulation (NMES) and high protein supplementation (HPRO) will~     improve muscle mass, metabolic and inflammatory biomarker profiles, compared to SAH controls~     receiving standard of care interventions for nutrition and mobilization. The investigators~     will accomplish this by studying the effects of a high protein (HPRO) nutritional treatment~     as well as NMES intervention have upon muscle wasting and motor strength acutely after SAH.~     This will be addressed in a prospective trial of SAH patients receiving HRPO with NMES as~     compared to age and severity-matched SAH patients undergoing standard of care interventions~     for nutrition and mobilization. Additionally, the study will investigate the impact HPRO and~     NMES interventions have upon inflammatory cytokines and markers of energy balance. Results of~     this study will establish evidence for precision nutrition plus early exercise to mitigate~     the catabolic and inflammatory state produced by SAH to improve muscle, metabolic, and health~     recovery outcomes.~   "
27954|NCT03201081|"~     Lack of physical activity is one of the major causes for obesity and functional disability in~     the elderly. Including regular exercise in elderly´s lifestyle is not an easy task. The main~     objective was to analyse the effect of a motivational resistance-training programme on~     satisfying the individual´s psychological needs, level of self-determination and body~     composition. A quasi-experimental study was performed with 47 volunteers (29 females, 18~     males) of 67-75 years of age, divided into two groups: experimental (n = 27) and control (n =~     20). A 12-week intervention programme was performed, with a total of 36 sessions.~   "
27955|NCT03201068|"~     This study will define the impact of a probiotic supplement on microbiome, immune system, and~     metabolic syndrome. This study will determine the degree to which a probiotic supplement can~     1) improve metabolic markers and metrics of metabolic syndrome, 2) alter microbiota~     composition and function, 3) impact microbiota metabolites, short-chain fatty acids—potential~     normalizers of metabolic and immune dysfunction, and 4) regulate immune status and function~     including reducing chronic, systemic inflammation as assessed by high dimensional immune~     profiling.~   "
27956|NCT03201055|"~     This study will aim to assess the acceptance of the Snore PAP system as a treatment concept~     for snore. The study will subjectively assess participant and bed partner acceptability and~     usability of the Snore PAP system and objectively assess participant compliance with the~     Snore PAP system.~   "
27958|NCT03201029|"~     As a physician, narrowing ones' practice to a particular pathology or group of people is~     common. Dermatologists are able to concentrate within a number of different areas: cancer,~     cosmetics, pediatrics or ethnic populations to name a few. Recently, there has been an~     emphasis on developing skin of color (SOC) clinics and recruiting dermatologists who focus on~     skin diseases that effect patients with skin of color. In this study, patients with SOC is~     defined to encompass that of persons of African, Asian, Native American, Middle Eastern, and~     Hispanic backgrounds. An emphasis on SOC benefits patients in a variety of ways: 1) these~     dermatologists are trained to recognize pathology that may present differently, depending on~     the Fitzpatrick skin type and ethnicity of the patient, 2) these dermatologists are trained~     to address medical disparities that are present among patients with SOC, 3) these~     dermatologists are trained to address culturally sensitive topics that may be common among~     patients with SOC. Despite the growing number of SOC patients and the benefit that SOC~     clinics provide, studies have not looked at the characteristics that influence dermatologists~     to focus on SOC as opposed to other specialty areas. Therefore, we aim to identify~     information that may influence dermatologists to focus on skin disease prevalent among~     patients with SOC.~      Currently, there are nine academic institutions with an Ethnic Skin Center in the United~     States. Given the limited number of academic centers with a designated center focused on SOC,~     a lot of care of skin of color patients happens in private practices. This is supported by~     the fact that many of the members in the Skin of Color Society are dermatologists in private~     practices. Thus, SOC clinic is defined broadly in our study to encompass not only academic~     dermatologists but also private practice dermatologists who have special interest in care of~     skin of color patients. Regardless of the type of practice, we hope to identify unique~     characteristics of dermatologists focusing on SOC skin diseases.~   "
27959|NCT03201016|"~     Osteoporosis is a common complication in chronic liver disease, especially in the late stages~     of the disease. Good nutrition and calcium and vitamin D supplementation are recommended for~     the prevention and treatment of osteoporosis. There are no specific guidelines for its~     pharmacological treatment, but bisphosphonates have been shown to be effective in increasing~     bone mass in patients with chronic cholestasis, with a good safety profile.~      There are few studies evaluating the prevalence of osteoporosis in patients with cirrhosis~     (except for primary biliary cholangitis (PBC)). There are no clear recommendations for~     osteoporosis screening in cirrhotic patients. A diagnosis and early therapeutic intervention~     before the onset of the complications derived would significantly improve the quality of life~     and decrease the morbidity and mortality associated with osteoporosis and fractures~      Objective:~      -To assess the prevalence of osteoporosis and fragility fractures in patients with liver~     cirrhosis in our country and the risk factors associated~      Method:~      Patients diagnosed with hepatic cirrhosis, other than PBC, will be included in any Child~     stage during a hospital admission. Epidemiological, demographic, clinical, analytical and~     imaging data (dorso-lumbar spine radiography, bone densitometry and Trabecular Bone Score)~     will be evaluated. A descriptive statistic of the main variables will be carried out as well~     as a multivariate analysis to evaluate the predictive factors of osteoporosis and / or~     fragility fractures~   "
27960|NCT03201003|"~     The purpose of this study is to demonstrate the efficacy and safety of AR101 through~     characterized oral desensitization immunotherapy (CODIT) in peanut-allergic children.~   "
27961|NCT03200990|"~     The objective of this study is to determine ventricular loading conditions during and after~     PulseCath® iVAC2L support, and assess its impact on specific load dependent humoral factors~     and cardiac enzymes. These specific patterns are so far unknown and will be compared with the~     validated FDA-cleared and CE marked Impella CP. Ten cases with Impella CP will be performed~     in this study to obtain the exact same measurements for comparing purposes.~   "
27962|NCT03200977|"~     An observational database analysis, using existing data of patients diagnosed with Classical~     Hodgkin Lymphoma.~   "
27963|NCT03200964|"~     Database registering demographic patient data, anesthesia and surgery information, post~     operative recovery and complications if any.~   "
27964|NCT03200951|"~     Ultrasonography of optic nerve sheath diameter shows a good level of diagnostic accuracy for~     detecting intracranial hypertension. The aim of this study is to evaluate the effect of~     epidural block on intracranial pressure in pediatric patients with cerebral palsy undergoing~     osteotomy of lower extremity. Forty patients, aged 4 years to 13 years, receiving epidural~     block before osteotomy will be divided into bolus group (n=20) and infusion group (n=20).~     Randomly selected patients of the bolus group are given 0.3 ml/kg bolus of 0.15% ripivacaine~     for epidural block. In contrast, patients in the infusion group are given 0.3 ml/kg/hr 0.15%~     ripivacaine for epidural block. The primary endpoint is the difference in the optic nerve~     sheath diameter after epidural block measured by optic nerve ultrasonography between groups.~   "
27965|NCT03200938|"~     Randomized clinical study in pulpotomies of deciduous molar teeth. A comparison of two~     techniques is established.~   "
27966|NCT03200925|"~     The main purpose of this study is to determine the effect of prenatal video education on~     pregnant women's intention to practice and actual practice of skin to skin contact (SSC)~     after birth. This study hypothesizes that education in video format will increase patients~     knowledge about skin to skin in a way that will make them consider participating in skin to~     skin immediately after birth.~      Therefore the end point for this study is intention to participate in SCC measured by a~     single questionnaire item Do you plan on participating in skin to skin (or kangaroo care)~     immediately after birth? Our secondary end-point will measure whether or not the patient was~     able to participate in skin to skin within five minutes of delivery.~      All study participants will complete a short survey about their intention of practicing skin~     to skin after birth upon admission for delivery. Half of the study participants will only~     complete the brief survey. The other half of study participants will then watch a short video~     about skin to skin and complete one follow up question regarding their intention to practice~     skin to skin at the time of delivery. All patients will be followed until after delivery to~     determine if they were able to participate in skin to skin after delivery.~   "
27967|NCT03200912|"~     The objective of this study was to evaluate the safety and therapeutic equivalence of generic~     ingenol mebutate gel, 0.015% to Picato gel, 0.015% by establishing the therapeutic~     comparability of the two active products and the superiority of the two active products over~     the vehicle gel in the treatment of AK on the face and scalp.~   "
28021|NCT03200210|"~     The investigators will enroll continuous ambulatory peritoneal dialysis (CAPD) patients with~     hyperuricemia and randomly divide them into two groups, treated with Febuxostat and placebo~     respectively. After 3 years of following up, cardiovascular events, all cause mortality,~     cardiovascular mortality and non-fatal cardiovascular events are collected and recorded. The~     difference of cardiovascular events, all cause mortality and non-fatal cardiovascular event~     rate will be analyzed.~   "
29908|NCT03175549|"~     The primary hypotheses under test are that alcohol dependent subjects treated with apremilast~     will report decreased craving for alcohol following alcohol exposure in the laboratory and~     report significantly less drinking under naturalistic conditions, than those treated with~     placebo.~   "
27968|NCT03200899|"~     The effects of multiple sclerosis (MS) on cognition, thought to occur in 50-75% of persons~     with MS, have gained increasing recognition as one of the major disabling symptoms of the~     disease. While numerous studies have addressed the emotional and physical impact of MS,~     little attention has been given to strategies that might help manage the cognitive changes~     commonly experienced by persons with MS. The proposed study will test a novel~     computer-assisted cognitive rehabilitation intervention, MAPSS-MS (Memory, Attention, &~     Problem Solving Skills for Persons with MS). The MAPSS-MS integrates the powerful effects of~     group interventions to build self-efficacy for new cognitive compensatory~     strategies/behaviors with individual home-based computer-assisted training. The computer~     training will assist individuals to develop cognitive skills that they can apply to everyday~     life using the compensatory strategies learned in the class sessions. In the recently~     completed exploratory study with 61 persons with MS (R21NR011076), the eight-week MAPSS-MS~     intervention was acceptable and feasible and had medium to large effects on the use of~     compensatory strategies and performance on neuropsychological tests of verbal memory. The~     proposed study will test the refined MAPSS-MS intervention with a larger more diverse sample~     (N=180) across multiple sites, extend the period of post-intervention follow-up to 6 months~     and establish whether performance improvements on neuropsychological tests make the important~     transfer to improved neuro-cognitive functioning in everyday life.~      The specific aims of this study are to: (1) Evaluate the efficacy of the novel MAPSS-MS~     cognitive rehabilitation intervention to improve overall neuro-cognitive competence in~     activities of daily living including verbal memory performance, use of compensatory cognitive~     strategies and performance on cognitive-related instrumental activities of daily living~     (IADL) among persons with MS; (2) Evaluate the efficacy of the MAPSS-MS intervention to~     improve self-efficacy and related aspects of cognitive performance (non-verbal~     learning/memory, information processing speed and attention, verbal fluency and complex~     scanning and tracking) among persons with MS; and (3) Determine the number of intervention~     participants who achieve and maintain their self-identified cognitive goals three and six~     months following the intervention. The effects of the intervention on outcome variables will~     be assessed using a randomized controlled trial design with a comparison group receiving~     usual care computer games. Measurements of study variables will occur at baseline,~     immediately after the MAPSS-MS intervention, and three months and six months after the~     intervention is complete. Statistical analysis will include descriptive statistics and HLM~     analysis to account for the nested design. The intent-to-treat approach will be used.~      Public Health Statement: This research will provide new knowledge about an innovative~     intervention to improve memory, use of compensatory strategies, and performance of cognitive~     activities and instrumental activities of daily living for persons with MS. If effective, the~     intervention would provide a new and feasible approach to target a serious, debilitating~     problem commonly experienced by persons with MS.~   "
27969|NCT03200886|"~     Osteoarthritis of the trapeziometacarpal joint (TMJ), also called rhizarthrosis is a common~     disease, mostly affecting post-menopausal women. Intra-articular therapy with hyaluronic acid~     (HA) was usually recommended as a second-line treatment after failure of non-pharmacological~     modalities, only in early stages of the disease .Aim of the present observational,~     retrospective, comparative study is the assessment of the efficacy and tolerability of i.a.~     injections of an hybrid HA formulation (Synovial H-L®) in comparison to triamcinolone in~     patients with TMJ Osteoarthritis (OA). We are analyzing the records collected in the~     departmental archives of outpatients affected by TMJ OA, according to the ACR criteria for~     the classification for hand OA and who were treated with i.a. Sinovial H-L or triamcinolone~     acetonide from December 1st, 2015 to December 1st 2016.The patient's assessment of~     spontaneous hand pain on a 0-100 mm VAS with 0 representing the absence of pain and the FIHOA~     score validated in Italian language were routinely recorded and documented in our centre~     prior to the injections (T0), at the time of the second i.a. administration (T1), after one~     month (T2) and after 3 (T3) and 6 months (T4) following the i.a. therapy.~      The primary outcome criteria of our study is the change of VAS and FIHOA from baseline to the~     end of treatment. Furthermore, we chose as secondary outcomes the duration of morning~     stiffness, the Italian version of Health Assessment Questionnaire (HAQ) and the validated~     Italian version of the Medical Outcomes Study 36-Item Short Form (SF-36) routinary registered~     in our medical record before the i.a. therapy, at the end of the treatment and after 1, 3 and~     6 months.~      The chi square test, t test or Kruskal-Wallis test, as appropriated, will be used to evaluate~     differences between groups before i.a. treatment the clinical and demographical data.~      Mixed-effects linear regression models will be used to evaluate temporal trends and~     differences in the two groups for specific outcomes: VAS pain, VAS stiffness, FIHOA and PCS~     and MCS from SF-36 questionnaires. In these types of statistical models, the effects of the~     covariates and their standard errors are correctly estimated taking into account the~     hierarchical structure of the data (i.e., patients and visits). For the compute of SF-36s Z~     score will be used mean and SD of U.S. general population. Data analysis will be performed~     using Stata vers 13.0 software. Descriptive statistics will be used to summarize data as~     frequencies (categorical variables) or mean +/-SD (continuous variables) as appropriate. P~     values <0.05 is considered statistically significant.~   "
27970|NCT03200873|"~     Impulsivity describes the tendency to make risky and unplanned decisions, to pick immediate~     reward over a bigger reward after a period of time or to not be able to resist the urge to do~     something. Empathy refers to the ability to be sensitive to and vicariously experience other~     people's feelings and to create working models of emotional states. Recent neuroscientific~     research have found that the right frontal part of the brain (left dorsal lateral frontal~     cortex, LDLPFC) is important in the control of impulsive behaviour and empathy. Self-report~     questionnaires have been proven valid measures at assessing impulsivity and empathy.~     Repetitive Transcranial Magnetic Stimulation (rTMS) is a widely used non-invasive brain~     stimulation procedure; stimulation can be applied at different brain regions depending on the~     administration method. It temporally changes the way that this part of the brain functions,~     providing us a further understanding of how this part works. Recent research has found that~     rTMS on the LDLPFC changes performance-based tasks measuring different types of impulsivity~     and empathy. This study aims to investigate this further to look at the RDLPFC stimulation~     and its effects on empathy and two different types of impulsivity. Of interest is also how~     innate impulsive personality type and empathy trait relate to performance on these tasks.~   "
27971|NCT03200860|"~     Acute decompensated heart failure is the fastest growing disease in the world and the leading~     cause of hospital admissions worldwide. Short term mortality and rehospitalization are~     extremely high (20-30% within 3-6 months) and there is no therapy available that improves~     clinical outcome in these patients. Empagliflozin is a selective inhibitor of sodium glucose~     co-transporter with diuretic and renal- protective properties. In patients with type 2~     diabetes at high risk for cardiovascular events, empagliflozin reduced the risk of~     hospitalization for heart failure by 35%. Based on the promising pharmacological profile of~     empagliflozin in relation to the needs for treatment of acute decompensated heart failure, we~     hypothesize that empagliflozin exerts positive effects in acute decompensated heart failure,~     with or without diabetes,~      This is a randomized, placebo-controlled, double-blind, parallel group, multicenter study in~     subjects admitted for acute decompensated heart failure. Eighty eligible subjects will be~     randomized in a 1:1 ratio to receive either empagliflozin 10 mg/day or matched placebo.~   "
27972|NCT03200847|"~     This is a Phase I/Ib investigator-initiated open label of the combination of VESANOID and~     pembrolizumab treatment.~   "
27973|NCT03200834|"~     Comparing different method of surgical technique D2 lymph node dissection vs D3 for right~     colon cancer.~   "
27974|NCT03200821|"~     In this study 250 µg of G17DT was administered at Weeks 0, 2 and 6 in order to demonstrate~     non inferiority compared to gemcitabine in prolonging survival in advanced pancreatic cancer.~   "
28022|NCT03200197|"~     The objective of this study was to compare the effectiveness of menthol chewing gum compared~     to maintained fasting (usual care) in reducing the intensity of the surgical patient's thirst~     during the preoperative period. The hypothesis of the study was that the use of menthol~     chewing gum in surgical patients in the preoperative period would be more effective than the~     maintenance of fasting with regard to the decrease in thirst and its discomforts.~   "
27975|NCT03200808|"~     The aim of this study is to demonstrate the safety and effectiveness of mixed methylene blue~     compound Injection for the treatment of nonneoplastic epithelial disorders（NNEDS） of vulva.~      NNEDS of skin and mucosa of vulva refer to a group of chronic diseases including squamous~     hyperplasia and lichen sclerosus, which mainly cause vulvar itching and hypopigmentation.~     Usually the itching is severe may influence social activities and sleep. In addition, NNEDS~     cause scarring of the vulva which may cause significant sexual dysfunction or pain. The~     reasons for NNEDs are not clear and the methods of treatment are diverse. The current~     treatments are primarily local drug (e.g. steroid, calcineurin inhibitors, immunosuppressive~     agents ), surgical treatments, laser or photodynamic therapy, and the gold standard~     treatment for lichen sclerosus is potent steroids creams. However, all the treatments are not~     good enough, and the diseases often recur and severely affect women's quality of life. So the~     investigators reviewed plenty of literatures, and found some authors used single intradermal~     1% methylene blue injection for intractable idiopathic pruritus ani and the effect was good.~     As a preliminary experiment, the investigators used intradermal mixed methylene blue compound~     injection for a NNEDs patient in the year of 2012, the itching of the patient stopped~     immediately and the color of the vulva recovered 6 months later. The patient keeps healthy~     till now. And from then on, the investigators designed this study and to verify the effect~     and complications of intradermal mixed methylene blue compound injection for the treatment of~     NNEDS. So far, there is no similar study reported internationally.~   "
27976|NCT03200795|"~     Background. Diabetes is a global epidemic disease. The prevalence of diabetes for all age~     groups worldwide was estimated to be 2.8% in 2000 and is predicted to affect 4.4% by 2030.~     The global prevalence of diabetics is currently estimated to be 285 million and projection~     rates are expected to rise to over 438 million by the year 2030, with Asians suffering the~     bulk of the total diabetes epidemic.~      The incidence of chronic diseases of lifestyle such as Type 2 Diabetes Mellitus (DM) is on~     the increase amongst the South African population. Due to the numerous factors such as lack~     of education, inaccessibility of healthcare facilities and/or poor socio-economic background,~     diabetes mellitus often goes undetected in rural areas, resulting in an increase in~     musculoskeletal complication and other diabetes mellitus complications. Inability to control~     blood sugar may induce serious complications such as renal disease, peripheral neuropathy,~     retinopathy, and vascular events. Due to its multi-systemic nature, diabetes will lead to the~     development of additional manifestations such as musculoskeletal complications, reduces~     respiratory capacity, depression and poor quality of life.~      Studies have shown that both exercises and pharmacotherapy can decreases depression and~     improved glycemic control and overall quality of life of persons with diabetes. Thus, in~     addition improve the quality of life and substantial financial savings and improved medical~     care of these individuals.~      Hypothesis~        1. There will be no statistical significant difference in glycemic control, cholesterol~          level, respiratory parameters, pain scores, depression and quality of life among type 2~          diabetes patients at the baseline and at the end of 8 weeks of rebound exercises.~        2. There will be no statistical significant difference in glycemic control, cholesterol~          level, respiratory parameters, pain scores, depression and quality of life among type 2~          diabetes patients at the baseline and at the end of 8 weeks of circuit resistance~          training.~        3. There will be no statistical significant difference in glycemic control, cholesterol~          level, respiratory parameters, pain scores, depression and quality of life among type 2~          diabetes patients at the baseline and at the end of 8 weeks of routine care.~        4. There will be no statistical significant difference in glycemic control, cholesterol~          level, respiratory parameters, pain scores, depression and quality of life among type 2~          diabetes patients between the rebound exercises group, circuit training and routine care~          at the baseline.~        5. There will be no statistical significant difference in glycemic control, cholesterol~          level, respiratory parameters, pain scores, depression and quality of life among type 2~          diabetes patients between the rebound exercises group, circuit training and routine care~          at the end of 8 week of the programme.~      Summary of the proposed research methodology. The participants will be randomised into three~     groups. The first group will be engaged in rebound exercise, the second group will be engaged~     in circuit training while the third group will continue with their normal care of medication.~     But before the commencement of the study, pilot study will be conducted on normal subjects.~     Measurement will be carried out at the baseline, four weeks and at the end of the programme,~     'The following parameters will be measured. Pain level, blood glycemic level of each~     participant, cholesterol level, depression and quality of life.~   "
27977|NCT03200782|"~     The purpose of the study is to investigate whether hypoglycaemia observed after food intake~     in bariatric patients can be either influenced by an SGLT2 inhibitor, empagliflozin, or via~     inhibition of inflammation with an human interleukin-1 receptor antagonist (IL1-RA,~     anakinra).~   "
27978|NCT03200769|"~     Study of the Efficacy of the Treatment of Sleep Apnea Syndrome by CPAP in Pharmacoresistant~     Epilepsy. The primary goal is to evaluate the efficacity after 3 months of obstructive sleep~     apnea syndrome treatment by CPAP on the epilepsy seizures frequency.~   "
27979|NCT03200756|"~     This trial randomizes patients who plan to attend cardiac rehabilitation to either a~     behavioral intervention to specifically reduce sedentary behavior or to usual care which~     exclusively focuses on increasing exercise.~   "
27980|NCT03200743|"~     Catestatin is a kind of protein involved with cardiovascular disease. Accumulated evidence~     shows that Catestatin may be a predictor of primary hypertension, but whether it plays the~     same role in pregnant hypertensive disorders needs to be determined. By measuring the plasma~     level of Catestatin, main biochemical marks and UCG in healthy pregnancy and pregnancy with~     hypertension, the research may contribute to this problem.~   "
27981|NCT03200730|"~     Background: The lack of a holistic approach to palliative care can lead to a fractured sense~     of dignity at the end of life, resulting in depression, hopelessness, feelings of being a~     burden to others, and the loss of will to live among terminally-ill patients. Building on the~     clinical foundation of Dignity Therapy, together with the empirical understanding of~     dignity-related concerns of Asian families facing terminal-illness, a novel Family Dignity~     Intervention (FDI) has been developed for Asia palliative care. FDI comprises a recorded~     interview with a patient and his/her primary family caregiver, which is transcribed, edited~     into a legacy document, and return to the dyads for sharing with the rest of the patient's~     family. The aims of this study are to assess the feasibility, acceptability and potential~     effectiveness of FDI in reducing psychosocial, emotional, spiritual, and psychophysiological~     distress in community-dwelling and in-patient Asian older terminally-ill patients and their~     families living in Singapore.~      Methods/Design: An open-label multicentre randomized controlled trial. 126 patient-family~     dyads are randomly allocated to one of two groups: (i) intervention group (FDI offered in~     addition to standard psychological care), and (ii) control group (standard psychological~     care). Both quantitative and qualitative outcomes are assessed in face-to-face interviews at~     baseline, three days and two week after intervention, and during an exit interview with~     family caregivers at two month post bereavement. Primary outcome measures include sense of~     dignity for patients and psychological distress for caregivers. Secondary outcomes include~     meaning in life, quality of life, spirituality, hopefulness, perceived support and~     psychophysiological well-being, as well as bereavement outcomes for caregivers. Qualitative~     data are analyzed using Framework method.~      Discussion: To date, there is no available palliative care intervention for dignity~     enhancement in Asia. This first-of-its kind study develops and tests an evidence-based,~     family-driven psycho-socio-spiritual intervention for enhancing dignity and wellbeing among~     Asian patients and families facing mortality. It address a critical gap in the provision of~     holistic palliative care. The expected outcomes will contribute to advancements in both~     theories and practices of palliative care for Singapore and other Asian communities around~     the world.~   "
27982|NCT03200717|"~     An international, multicenter, single arm Phase II trial to determine the efficacy, safety~     and quality of life of pazopanib treatment after previous therapy with immune checkpoint~     treatment. Approximately 100 patients will be enrolled, with approximately 40 of those~     patients receiving pazopanib as 2nd-line therapy. Patients will receive treatment with~     standard dose pazopanib until disease progression, unacceptable toxicity, pregnancy, death,~     discontinuation from the study treatment for any other reason or until study end. All~     patients will be followed for survival. Patients who discontinue treatment without documented~     disease progression will be followed for efficacy.~   "
27983|NCT03200704|"~     This is a randomized, prospective, open label, multicenter study to assess the effectiveness~     of IC2000 and SPY Fluorescence Imaging Systems (SPY) in the identification of lymph nodes~     during lymphatic mapping in subjects with breast cancer.~   "
27986|NCT03200665|"~     Sonographic fetal weight estimation at the last weeks of third trimester in low-risk~     pregnancies is an effective method for diagnosis of fetal growth restriction (FGR) permitting~     close surveillance and timely delivery. The need for a systematic ultrasound evaluation at~     the last weeks of a low-risk pregnancy and the best time to perform it remains controversial.~     The most commonly used clinical screening tool in this population is the serial measurement~     of symphysis-fundus distance, which is a method of a variable and low sensitivity for~     detection of FGR.~      In Portugal, in accordance with guidelines of Direcção Geral de Saúde from 2015, fetal growth~     restriction screening in low risk pregnancies is performed with an ultrasound for fetal~     weight estimation at 30th-33rd weeks. Nonetheless, recent data from randomized trials showed~     that FGR detection rate was superior at 36 vs 32 weeks' gestation. In cases of severe FGR,~     detection rate was also superior at 36 vs 32 weeks' gestation. In a prior retrospective~     study, our group analyzed 1429 term low risk pregnancies and the investigators concluded that~     small for gestational age term babies (birthweight < 10th centile) had a statistically~     significant higher rate of operative deliveries for intrapartum fetal distress than~     appropriate for gestational age as well as a higher rate of admission to neonatal intensive~     care unit. Moreover the investigators compared the same outcomes within small for gestational~     age neonates with antepartum detection at 30th-33rd weeks ultrasound vs undetected (normal~     30th-33rd weeks ultrasound). Antepartum detection of small for gestational age neonates~     showed a statistically significant lower rate of operative deliveries for intrapartum fetal~     distress than undetected small for gestational age neonates. The investigators will conduct a~     prospective randomized clinical trial with the aim to evaluate if a 35th-37th weeks after the~     standard of care ultrasound in low risk pregnancies is effective in improving the detection~     rate of FGR and in reducing cesarean deliveries for intrapartum fetal distress and admission~     to neonatal intensive care unit.~   "
27987|NCT03200652|"~     Protein is the key determinant of growth and bodily functions. The quality of food proteins~     depend on their amino acid content and the amount of amino acids used by the body to make~     proteins. Globally Cereal Grains (CG) provide 50% of the calories and protein in the diet and~     exceed 80% in poorer developing countries. In many of those countries, wheat is the major~     cereal grain in the diet. The protein in wheat is low in the essential amino acid lysine.~     Hence wheat protein is of low quality. Low lysine affects protein synthesis in the body.~     Cooking methods also affect the lysine available from foods to the body.The protein can be~     complemented by the addition of lentils to augment the low lysine content. However, lentils~     are prohibitively expensive in some developing countries.~      As the human population increases, the world faces the continuous challenge of maximizing a~     limited food supply. Protein quality (PQ) evaluation of wheat directly in humans would allow~     us to bridge the gap in knowledge between what is required and how best to provide.The~     information gathered from this project will provide the first direct experimental data on PQ~     of wheat protein in humans on which nutrition recommendations can be built.~   "
27988|NCT03200639|"~     The study aim was to compare the effectiveness of combined training (CT; aerobic + resistance~     exercises) and high-intensity interval body weight training (HIITBW) on body composition,~     metabolic and inflammatory profile, physical function and quality of life in older women with~     gynecological and breast cancer and their pair-matched controls (older women with no cancer).~     The hypothesis of the present clinical trial is that HIITBW is effective as well as CT for~     improvements on body composition, metabolic and inflammatory profile, physical function and~     quality of life in older women with gynecological and breast cancer.~   "
27989|NCT03200626|"~     Prospective, multicenter, observational registry of myeloma patients undergoing hematopoietic~     progenitor cell mobilization for upfront autologous transplantation.~   "
27990|NCT03200613|"~     Thromboprophylaxis options are limited for patients with acute spinal cord injury (SCI) and~     there are no studies on direct oral anticoagulants (DOACs) for thromboprophylaxis in this~     population. Participants will be randomized to apixaban 2.5 mg twice daily or standard dose~     low-molecular-weight heparin (LMWH), either enoxaparin 40 mg or dalteparin 5000 units,~     subcutaneously once daily for 90 days or until fully mobilized, whatever comes first.~     Thromboprophylaxis will be started as soon as hemostasis is achieved. The primary outcome for~     this pilot study will be the recruitment rate per year (i.e. the screened to enrolled ratio).~     The primary efficacy endpoint will be a composite of symptomatic, objectively verified,~     venous thromboembolism (VTE), defined as upper or lower limb deep vein thrombosis (DVT)~     and/or pulmonary embolism (PE) or sudden death where PE cannot be excluded. The primary~     safety endpoint will be major bleeding.~   "
27991|NCT03200600|"~     Delirium is a common complication in elderly patients after surgery. And its occurrence is~     associated with worse outcomes. The causes of delirium are multifactorial but may include~     pain, stress response and inflammation. Dexamethasone is commonly used to prevent the~     occurrence of postoperative nausea and vomiting. In a randomized controlled trial, small-dose~     dexamethasone (8 mg) administered before anesthesia induction improved the quality of~     recovery in patients after cardiac surgery. Flurbiprofen axetil is commonly used to improve~     postoperative analgesia while decreasing the requirement of opioids. In a randomized trial of~     the investigators, combined use of flurbiprofen axetil with sufentanil for postoperative~     analgesia reduced delirium in elderly patients after orthopedic surgery. The purpose of this~     2 plus 2 factorial randomized controlled trial is to test the hypothesis that combined use of~     dexamethasone and flurbiprofen axetil may reduce delirium in elderly patients after lung~     cancer surgery.~   "
27992|NCT03200587|"~     This is an open-label, non-controlled, non-randomized, phase I dose-finding, of Cabometyx +~     Avelumab, to establish safety, feasibility, and the maximum tolerated dose (MTD) or~     Recommended Phase 2 Dose (RP2D) of Cabometyx in combination with Avelumab, and to investigate~     preliminary efficacy. The MTD or RP2D determined in this study will be used for a future~     study to formally test efficacy.~   "
27993|NCT03200574|"~     This is a prospective, interventional, multi-center trial to report the overall incidence of~     reduced leaflet motion identified by CT imaging in patients receiving a commercially approved~     LivaNova bioprosthetic aortic heart valve up to 1 year post implant.~   "
28023|NCT03200184|"~     The fixed-dose combination of sofosbuvir and daclatasvir in a single pill is being used for~     the treatment of hepatitis C in Iran. In this study the efficacy of this combination is~     evaluated in 1000 patient with hepatitis C.~   "
28024|NCT03200171|"~     Investigators aim to study the effect of direct acting antiviral agents (DAAs) on behavior of~     hepatocellular carcinoma (HCC) and overall survival in patients with chronic hepatitis C~     (CHC).~   "
28025|NCT03200158|"~     To study the changes of barrier and immune function in Stress Related Mucosal Disease (SRMD).~   "
28026|NCT03200145|"~     Cohort Observational Study. The study will assess differences in quality of life, well-being~     and mood between persons living in a nursing home following usual care and persons living in~     nursing homes following a centered person care model.~      Initially, the follow up will last 6 months, with the possibility to be extended.~   "
28027|NCT03200132|"~     This study evaluates the possibility of Magnetic Resonance Imaging (MRI) based respiratory~     motion correction of simultaneously acquired cardiac Positron Emission Tomography (PET)~     images.~   "
27994|NCT03200561|"~     Background:~      Kawasaki disease (KD), most popular acquired heart disease in childhood, is characterized by~     diffuse vasculitis, especially on the middle-sized muscular arteries. IVIG and aspirin are~     currently standard treatment. However, 10-15% of KD patients have poor response to such~     treatment and suffer from higher risk of coronary involvement. Recently, combination of~     prednisolone and IVIG has been shown effective to lower the chance of refractory to IVIG~     treatment and subsequent coronary lesions. However, no randomized trial on the steroid~     efficacy was ever conducted in Taiwan.~      Aim:~      Prospectively randomized open-label trial to evaluate the add-on effect of prednisolone in~     the refractory KD children.~      Methods:~      For the KD patients with fever persisted or relapsed 24 hours after the ending of IVIG~     infusion, they will be randomized into two group: IVIG group (I) and IVIG + prednisolone~     group (P). The KD patients in the P group will have in addition to IVIG, oral prednisolone~     2mg/kg/day for at least 5 days. The difference in the response rate and percentage of~     coronary involvement will be compared between I and P groups.~      Predicted results:~      We plan to enroll 100 refractory KD patients, 50 patients for each group. We predict the risk~     of coronary involvement can be reduced from 30% to 15%.~   "
27995|NCT03200548|"~     Systemic lupus erythematosus (SLE) is a complex autoimmune disease characterized by~     involvement of multiple organs with a female to male ratio of 12:1 with the highest incidence~     reported in women of child bearing age (15-44 years). In general, advances in diagnosis and~     management have led to significant improvements in outcomes. However, fatigue remains a~     challenging and prevalent issue for SLE patients.~      The investigators aim to determine the feasibility of recruiting and conducting acupressure~     in fatigued persons with lupus; to explore the effect of two distinct acupressure formulas~     (relaxing and stimulating) plus usual care versus sham acupressure plus usual care and usual~     care alone on severity and impact of chronic fatigue (as measured by the Brief Fatigue~     Inventory) as well as quality of life, sleep and pain.~   "
27996|NCT03200535|"~     Individuals with prediabetes are at increased risk for developing diabetes. Higher hemoglobin~     A1c's (6.1-6.4%) are associated with a high risk of developing diabetes. It is known that~     programs such weight management classes and one-on-one counseling with registered dieticians~     can lead to weight loss and decrease the risk of diabetes. However, engagement of Kaiser~     Permanente Colorado members in these activities is low. The purpose of this study is to~     determine which of three outreach methods is most effective in increasing engagement in these~     activities.~   "
27997|NCT03200522|"~     This research is being done to evaluate the feasibility of a prudent versus Western diet~     feeding study in women with asthma in Baltimore City. The results of this research will~     provide data to appropriately design a definitive study looking at the differential effects~     of these two diets on asthma health.~   "
27998|NCT03200509|"~     Physical activity plays an important role in the management of chronic low back pain (LBP).~     Engaging in an active lifestyle is associated with a better prognosis. Nevertheless, there is~     evidence to suggest that patients with chronic LBP are less likely to meet recommended~     physical activity levels. Furthermore, while exercise therapy has been endorsed by recent~     clinical practice guidelines, evidence from systematic reviews suggests that its effect on~     pain and disability are at best moderate and not sustained over time. A limitation of current~     exercises programs for chronic LBP is that these programs are not designed to change~     patient's behaviour toward an active lifestyle. Therefore, the objective of this study is to~     investigate the short and long-term efficacy of a multimodal intervention consisting of~     supervised exercises, health coaching and use of an activity monitor (i.e. Fitbit Flex)~     compared to supervised exercises plus sham coaching and a sham activity monitor on physical~     activity levels, pain intensity and disability in patients with chronic nonspecific LBP.~   "
27999|NCT03200496|"~     This is Open-label, Randomized, 3-sequence study to compare of pharmacokinetics and~     safety/tolerability profiles betweens DA-5206, a SR formulation of bepotastine besilate and~     Talion®, a IR formulation of bepotastine besilate under fasting and fed states in healthy~     male subjects~   "
28000|NCT03200483|"~     Check the effects of musical auditory stimulation on the autonomic modulation and~     cardiorespiratory parameters during and after aerobic exercise. Hypothesized that classical~     music can increase recovery velocity after exercise and rock style music can generate a delay~     in the recovery velocity of the cardiorespiratory parameters and in the cardiac autonomic~     response.~   "
28001|NCT03200470|"~     This is a prospective multicenter study. All patients presenting for revision hip or knee~     arthroplasty for all indications under the respective surgeon's care may be eligible. Per~     standard of care preoperatively, all patients must have blood drawn for erythrocyte~     sedimentation rate(ESR), C-reactive protein(CRP) and D-dimer. Aspiration of the joint in~     question may be performed at the discretion of the treating surgeon and results documented.~     Intraoperative samples will also be collected and sent for NGS analysis~   "
28002|NCT03200457|"~     The study proposes to compare the results of two examinations at 1.5 and 3 Tesla obtained on~     the same day on a series of 80 patients.~   "
28003|NCT03200444|"~     This study investigates the impact and adhesion of new adhesives to the skin.~   "
28004|NCT03200431|"~     The purpose is to investigate the impact real output has on the peristomal skin covered by a~     newly developed adhesive.~   "
28005|NCT03200418|"~     The study investigates the impact real output has on the adhesion of the adhesives.~   "
28006|NCT03200405|"~     The purpose of this study is to determine the exact position of a mesh which is placed in~     underlay position in umbilical hernia in vitro. The investigators want to gain information if~     the mesh lays directly next to the abdominal wall fascia or if there´s fat tissue between~     mesh and fascia. Furthermore they hope to get some information about the tissue~     incorporation.~   "
28007|NCT03200392|"~     A clinical and radiographic evaluation of using Erbium, Chromium, Scandium, Gallium and~     Garnet (Er,Cr:YSGG) laser in recipient site bio-modification and de-epithelialized connective~     tissue graft harvesting compared to conventional scalpel surgical technique in the treatment~     of class I and II Miller gingival recession.~   "
28008|NCT03200379|"~     To determine the treatment efficacy, safety and long-term outcomes of chronic hepatitis C~     patients receiving directly acting antivirals in Taiwan~   "
28028|NCT03200119|"~     In order to study the effectiveness of personalized healthcare intervention for~     lifestyle-related diseases, investigators designed this study using mobile application and~     clinical feedback from clinicians~   "
28009|NCT03200366|"~     The purpose of this study is to test different approaches to help people understand the~     purpose of colorectal cancer (CRC) screening, two screening test options available, and the~     barriers to screening so they can make informed decisions about CRC screening. Participants~     will be randomly assigned to one of three groups: (1) one group will receive a tailored~     digital video disc (DVD) in the mail; (2) another group will receive the mailed DVD plus~     telephone calls from a patient navigator; and (3) the third group will receive the care~     normally provided by the healthcare system's endoscopy department.~      The investigators hypothesize the following: (1) participants who receive the tailored DVD~     plus the patient navigation intervention will have higher rates of CRC screening with the~     fecal immunochemical test (FIT), colonoscopy, or either screening test compared to those who~     receive the tailored DVD alone; (2) participants who receive either intervention (DVD only or~     DVD plus patient navigation) will have higher rates of CRC screening with FIT, colonoscopy,~     or either screening test than those who receive usual care; and (3) participants who receive~     either intervention who complete colonoscopy will have better quality of bowel preparation,~     less anxiety about the procedure, and greater satisfaction with the colonoscopy experience~     than those who receive usual care.~   "
28010|NCT03200353|"~     Patient with chronic wounds are selected to receive NATROX system ; it's a continous~     diffusion of oxygen therapy delivery system. This one is put on the wound during a~     consultation at the hospital and will be followed in home medical care. Every 2 days a nurse~     renew the application at home and patient recharge the system with oxygen every day.~      The complete treatment is prescribe for 4 weeks and at the end patient comes to hospital to~     have a consultation with the doctor.~   "
28011|NCT03200340|"~     This is a Phase 2, randomized, double-blind, placebo-controlled, 2-stage trial in subjects~     with squamous cell cancers of the mouth, oropharynx, hypopharynx and nasopharynx planned to~     receive standard fractionated IMRT-delivered radiotherapy with concomitant chemotherapy~     (cisplatin). Informed consent will be obtained from each subject prior to enrollment.~      The trial will be performed in 2 stages:~      Stage 1 will consist of a blinded parallel group safety study of 4 cohorts in which 24~     subjects will be randomized (1:1:1:1) into four equally sized groups to receive one of three~     doses of EC-18 (500 mg, 1000 mg, 2000 mg; unit dose of 500 mg) or placebo. Stage 2 of the~     study will evaluate both safety and efficacy.~      Sixty (60) subjects will be randomized in a 1:1 scheme to receive either placebo or EC-18 at~     the dose determined in Stage 1.~   "
28012|NCT03200327|"~     The investigators anticipate a reduced risk of post-operational de novo stress urinary~     incontinence following surgery for prosthetic vaginal sacrospinofixation, associated with~     reduced costs, comparable functional and anatomical efficacy and no increase in morbidity and~     rate of dyspareunia with the new treatment~   "
28013|NCT03200314|"~     A prospective, observational study will be performed measuring recirculation of blood through~     a veno-venous Extracoporeal Membrane Oxygenation (vvECMO) in patients with acute respiratory~     distress syndrome (ARDS) on vvECMO. ECMO blood flow will be adjusted with respect to~     recirculation.~   "
28014|NCT03200301|"~     The investigators hypothesise that intact umbilical cord milking (I-UCM) will reduce neonatal~     morbidity and improve long term neurodevelopmental outcome in very preterm infants. All~     babies born less than 32 weeks gestation, meeting the inclusion criteria will be randomly~     assigned to either I-UCM or immediate cord clamping (ICC) and their short and long term~     outcome measures analyzed.~   "
28015|NCT03200288|"~     This is a study to evaluate the Clinical Performance and Safety of a single intra-articular~     (i.a.) injection of hyaluronic acid product (as HL-01) in the treatment of pain due to~     osteoarthritis (OA) of the knee.~   "
28016|NCT03200275|"~     There has never been a paper published or research done to determine the rate of Legionella~     species as a cause of community or nosocomial acquired pneumonia requiring hospitalization in~     Malaysia. Anecdotally, Legionnaires' disease is thought to be uncommon in Malaysia. This is~     one of the first prospective hospital-based studies to comprehensively evaluate the~     epidemiological and demographical factors of patients hospitalized with Legionella infection~     in Malaysia.~   "
28017|NCT03200262|"~     The shoulder is the most mobile joint in the body, and the most exposed to the risk of~     dislocation notably anterior. Chronic instability of the shoulder is frequent after~     dislocation, and principally affects people who are young and active. It can have major~     functional repercussions, leading to restricted participation in professional or sports~     activities, even in everyday life activities.~      Surgical stabilisation is the reference treatment for chronic anterior shoulder instability,~     and has given good results. There are numerous surgical techniques available; the~     orthopaedists at Dijon CHU now practice the Bristow-Trillat technique under arthroscopy,~     following many years of reflexion and adaptation.~      Rehabilitation following the surgery is essential, notably to recover muscle strength in the~     shoulder rotator cuff after surgery, which correlates directly with dynamic stability of the~     joint. At the moment, we do not know the objective evolution of muscle strength after the~     Trillat arthroscopic technique.~      The isokinetic evaluation of muscle strength in the rotator cuff has been validated and is~     reproducible. It gives objective and reliable values for muscle strength, thus making it~     possible to guide and to optimise rehabilitation protocols done by patients under the~     supervision of a physiotherapist, and to estimate time to the return to physical,~     professional or sports activities, without risk.~   "
28018|NCT03200249|"~     Hypothesis : Therapeutic intensification by increasing the dose delivered to the tumor by~     RCMI (conformational radiotherapy by intensity modulation) in order to reduce local relapse,~     often associated with poor prognosis~      Primary objective: evaluate the rate of tumor sterilization and the toxicities of RTCT with~     concomitant boost in intensity modulation in patients with rectal cancer CT3-T4 and / or~     cN1-2.~   "
28019|NCT03200236|"~     The purpose of this study is to compare intensive telephone counseling (ITC) plus the~     nicotine patch vs. standard telephone counseling plus the nicotine patch (Usual Care; UC)~     among current smokers undergoing lung cancer screening. Smoking-related outcomes will be~     examined at three, six and twelve months post-randomization.~   "
28020|NCT03200223|"~     In order to study the effectiveness of personalized healthcare intervention for~     lifestyle-related diseases, investigators designed this study using mobile application and~     clinical feedback coaching.~   "
28029|NCT03200106|"~     Treatment of malignant ascites with the alfapump offers a new treatment option for this~     patient group. So far, there is no systematic analysis of patients with this indication~     available in the literature.~      This retrospective analysis offers the possibility to assemble already existing data within a~     reasonably short time frame. Based on this analysis, a prospective analysis can be designed.~   "
28030|NCT03200093|"~     This study evaluates the role of oral vancomycin in the prevention of recurrent Clostridium~     difficile for hospitalized patients receiving systemic antibiotic therapy. Half of~     participants will receive oral vancomycin daily, while the other half will receive a placebo.~   "
28031|NCT03200080|"~     This will be a single-dose, randomized, double-blind, active- and placebo-controlled, double~     dummy, 6-way crossover study to determine the abuse potential of tozadenant relative to~     d-amphetamine and placebo, when administered orally in healthy non-dependent, recreational~     polydrug users with stimulant experience, under fed conditions.~      Each subject will participate in a medical Screening visit, a 4-day (3-night) qualification~     (drug discrimination) visit, six 3-day (2-night) treatment periods, and a follow-up visit.~   "
28032|NCT03200067|"~     In order to study the effectiveness of personalized healthcare service program for breast~     cancer rehabilitation, investigators designed this study using mobile phone and clinical~     intervention(feedback coaching).~   "
28033|NCT03200054|"~     South Africa is implementing the policy of universal initiation of lifelong antiretroviral~     therapy (ART) in all HIV-infected pregnant women regardless of CD4 cell count or disease~     stage (Option B+). There is a recognised need for innovative models of service delivery to~     support adherence and retention in care in this group, particularly during the postpartum~     period. The investigators are conducting a pragmatic randomised control trial to compare~     virological outcomes 24 months postpartum in two models of service delivery for provision of~     HIV care and treatment services postpartum in women who initiated ART during pregnancy: local~     adult ART clinics and community-based adherence clubs.~   "
28034|NCT03200041|"~     The purpose of this study is to evaluate the performance of the IONA® test which is a~     non-invasive prenatal test (NIPT) for Down's syndrome and other chromosomal abnormalities in~     twin pregnancies, from a maternal blood sample.~   "
28035|NCT03200028|"~     The primary objective of this study is to evaluate the effects of the revised brain training~     program on the cognitive abilities (e.g., attention, executive function), functional status~     and quality of life of individuals diagnosed with Alcohol Use Disorder (AUD) and~     Post-Traumatic Stress Disorder (PTSD).~   "
28036|NCT03200015|"~     Evaluation of the safety and effectiveness of metformin as an adjunct to RCHOP chemotherapy~     for patients with newly diagnosed diffuse large-B cell lymphoma~   "
28037|NCT03200002|"~     This was a prospective open label randomized control trial, which was conducted for a period~     of one and half year from January 2014 to June 2015. Out of 52 patients screened, 49 patients~     meeting the international society of nephrology/ renal pathology society (ISN/RPS) criteria~     were enrolled in the study comprising of 25 and 24 patients in the cyclophosphamide (CYC) and~     mycophenolate mofetil (MMF) groups respectively. Forty two patients (21 in each group) could~     complete the study till the end of 6 months and were included in final analysis. Baseline~     clinical evaluation and investigations were done and recorded. CYC was given intravenously as~     a monthly pulse in the dose of 0.5 to 1 gram per m2 body surface area. MMF was administered~     in the tablet form with the starting dose of 500 mg twice daily, which was increased to 750~     mg twice daily after a month. Patients were assessed and monitored monthly and the details~     were recorded. Efficacy of treatment was measured as primary end point for those who achieved~     partial remission (reduction of 24 hour urinary protein to < 3.5gms/day if baseline~     proteinuria >3.5 gms/day or decrease by 50% if baseline proteinuria <3.5 gms/day) and~     secondary end point for those who achieved complete remission (normalization of serum~     creatinine and < 500 mg of 24 hour urinary protein). Adverse events experienced by the~     patients were also recorded during monthly visit.~   "
28038|NCT03199989|"~     The purpose of this study is to design a prospective randomized clinical trial to explore~     whether postoperative adjuvant chemotherapy may provide survival benefit for stage II colon~     cancer patients with high risk factors.Therefore the investigators can provide high level~     clinical evidence of indications for patients with colon cancer with stage II colon cancer.~   "
28039|NCT03199976|"~     This study evaluates the effect of intermittent tiotropium bromide and salbutamol as needed~     versus intermittent fluticasone propionate and salbutamol as needed, or solely, salbutamol as~     needed on episode-free days in infants and toddlers with recurrent episodes of wheeze and/or~     shortness of breath.~   "
28040|NCT03199963|"~     A study to determine the efficacy of 8 mg/day (4 mg/breast) of BHR-700 gel compared to~     placebo for reducing breast tissue density in women identified as having dense breast tissue~     upon analysis of screening mammography. The Primary Study Endpoint being the percent~     reduction of mammographic breast tissue density on a follow-up mammogram compared to the~     baseline mammogram after 52 weeks of treatment.~   "
28041|NCT03199950|"~     The hospital pharmacy at the Zuyderland Medical Centre developed the DElirium MOdel (DEMO) to~     predict which patients are at risk of developing a delirium in patients aged 60 or older.~     With this delirium risk prediction model we aim to predict more accurately which patients are~     at high risk of developing a delirium and want to investigate if these patients can benefit~     from prophylactic haloperidol.~   "
28042|NCT03199937|"~     The purpose of this project is to test the effectiveness of a novel school-based intervention~     targeting executive function skills, including flexibility and planning, in college-track,~     transition-age youth with ASD. Evaluating treatment change through behavior and brain~     activity provides important information on how the treatment works and who will best benefit~     from it.~   "
28043|NCT03199924|"~     to evaluate the analgesic effect of a standard dose of intravenous magnesium added to~     intramuscular diclofenac compared to intravenous lidocaine combined to intramuscular~     diclofenac or intramuscular diclofenac alone in patients presenting to the emergency~     department with renal colic and whether it can reduce opioid consumption.~   "
28044|NCT03199911|"~     The investigators propose a prospective randomized control trial testing the hypothesis that~     routine topical antibiotic prophylaxis does not significantly reduce the rate of infection~     after eyelid surgery.~   "
28045|NCT03199898|"~     Depending on their gestational age, preterm infants need several weeks with different types~     of breathing-support due to immature development of the lungs, respiratory muscles,~     chest-wall and respiratory center in the brain. WHO`s recommendation on interventions to~     improve preterm birth outcomes underline the need for more research on respiratory support in~     infants born preterm. This study will test inter-rater and intra-rater reliability of the~     Silverman-Andersen Retraction Score, which is a systematic clinical scoring tool for the~     respiratory work and the severity of respiratory distress in preterm infants. It will examine~     if there is consistency in the assessments done by doctors and nurses, and also if the~     observations correlate with technological monitoring. This easy to use scoring tool will help~     to determine the grade of respiratory distress, to assess respiratory exacerbation, to decide~     when to start weaning from respiratory support, and to give the best respiratory treatment to~     the child. This study will contribute to optimize care for preterm infants with respiratory~     distress.~   "
28046|NCT03199885|"~     This randomized phase III trial studies how well paclitaxel, trastuzumab, and pertuzumab with~     or without pembrolizumab works in treating patients with breast cancer that has spread to~     other parts of the body. Drugs used in chemotherapy, such as paclitaxel, work in different~     ways to stop the growth of tumor cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Monoclonal antibodies, such as trastuzumab,~     pertuzumab, and pembrolizumab, may interfere with the ability of tumor cells to grow and~     spread. Giving paclitaxel, trastuzumab, and pertuzumab with pembrolizumab may kill more tumor~     cells.~   "
28047|NCT03199872|"~     The study will evaluate safety and immunological response to RhoC peptide vaccine in patients~     with prostate cancer~   "
28048|NCT03199859|"~     1. Observe the characteristics of delirium patients, searching for early diagnostic methods~          or finding risk factors~        2. Design a guideline for delirium, diagnosis or treatment~   "
28049|NCT03199846|"~     This study will collect real-world data from advanced melanoma diagnosis through most recent~     visit and data sourced from patient medical records following a 2-part study design~     consisting of a random sample (Part 1) and an oversample (Part 2).~   "
28050|NCT03199833|"~     Stroke is the third most common cause of death and the main cause of acquired adult~     disability in high-income countries. The most common deficit after stroke is motor impairment~     of the contralateral arm, with more than 80% of stroke survivors experiencing this condition~     in the acute phase, and only half regaining some useful upper limb function after six months.~      Within the European project RETRAINER (grant agreement No 644721), the consortium developed a~     platform for the rehabilitation of the upper limb after stroke, which combines a passive~     forearm-hand orthosis for hand-wrist motion stabilization, selective fingers constraining and~     grasp movement facilitation, Functional Electrical Stimulation (FES) of the extrinsic hand~     flexor muscles and of the extrinsic hand extensor muscles, interactive objects, and voluntary~     effort. The system also provides a graphical user interface which helps the therapist set the~     training session and save the training data and parameters, and provides the subject a visual~     feedback about his/her active involvement in the exercise. The training consists of the~     execution of a series of exercises involving the affected arm during daily life activities.~     Typical exercises include controlled wrist flexion and extension, controlled fingers flexion~     and extension, anterior reaching and grasping on a plane or in the space, moving an object on~     a plane or in the space.~      The aim of this clinical study it to evaluate the efficacy of this novel training platform on~     patients between two weeks and nine months after their first stroke, who preserved at least a~     visible muscle contraction for the arm and shoulder muscles. Participants are randomized in~     an experimental and a control group. The control group is trained with an advanced~     rehabilitative program, including physical training, occupational therapy, FES, and virtual~     reality, while the experimental group is trained with the RETRAINER system for about 30~     minutes, in addition to the same program of the control group. The daily training time is the~     same for the two groups. The intervention consists of three sessions a week for nine weeks.~     Patients are assessed at baseline, soon after the end of the intervention, and in a 4-week~     follow-up visits. It is planned to recruit 68 subjects for this study. Since the RETRAINER~     platform was built on the up-to-date theory of motor re-learning, which supports~     task-oriented repetitive training, a close temporal association between motor intention and~     stimulated motor response, and an intensive and frequent training paradigm, the study's~     hypothesis is that the experimental group shows a greater treatment effect than the control~     group.~   "
28051|NCT03199820|"~     This study will randomise low-risk women to compare the effectiveness of trans-cervical~     balloon catheter for pre-induction cervical ripening for out-patient induction of labour with~     current practice (Propess). Women will be randomised to two treatment groups. The~     investigators wish to explore if such a trial is feasible, acceptable to women and what data~     collection is required for a future trial. Since no data exist, the investigators propose a~     study with approximately 60 women in each arm across two recruiting sites.~   "
28052|NCT03199807|"~     The study herein successfully developed a new immunotherapeutic approach combined with~     radiotherapy, and tried to proved it to be more effective and safe.~   "
28053|NCT03199794|"~     The study addresses the safety, utilisation and effectiveness of Obizur in the treatment of~     bleeding episodes in real-life clinical practice in Europe.~   "
28054|NCT03199781|"~     PURPOSE: To evaluate the efficacy of motorized mechanical massage associated with cosmetics~     in improving body contour and appearance of gynoid lipodystrophy.~      SUBJECTS AND METHODS: A prospective and comparative longitudinal clinical study will be~     performed in 30 women with localized fat and gynoid lipodystrophy. Patients will be submitted~     data collection and assessments and before and after treatment.~      HYPOTHESES: It is expected that the patients will present improvement in the body contour and~     in the picture of the gynoid lipodystrophy after the association of the therapies.~      STATISTICAL ANALYSIS: A descriptive analysis will be done before and after~     vibration-oscillatory therapy, with frequency tables for categorical and descriptive~     variables (mean, standard deviation, median, minimum and maximum values) for continuous or~     numerical variables. In order to compare the main variables between the groups and the~     collection times, the analysis of variance (ANOVA) for repeated measurements will be used.~     Tukey's test will be used to compare groups. The level of significance adopted for the~     statistical tests will be 5% or p <0.05.~   "
28055|NCT03199768|"~     To investigate whether single-bed rooms can prevent and reduce incidence and duration of~     delirium compared to multi-bed rooms in elderly patients admitted to a geriatric department.~     In addition, it is investigated whether single-bed rooms reduce the use of psychotropic~     drugs, opioids, parenteral medication, fixed guard, falls, hospitalization and discharge to~     institution among delirious patients. Furthermore, to study if delirium is associated with of~     re-hospitalization, traumatic fall, institutionalization and death within 30 days, compared~     to those who do not develop delirium.~   "
28056|NCT03199755|"~     The overall goal is to validate efficacy and potential superiority of dried leaf Artemisia~     annua (DLA) vs. artemisinin combination therapy (ACT) to cure malaria and to demonstrate~     elimination of the transmission stage (gametocytes) of the disease. This is a 3 arm trial in~     Democratic Republic of Congo covering 600 total adult and pediatric patients. Final~     validation of infection from dried blood samples will be done at WPI.~   "
28057|NCT03199742|"~     The purpose of this study is to evaluate a mobile phone app designed to help Veterans with~     PTSD. Participants in this study will be randomized to receive one of 2 possible mobile phone~     apps. The term randomized means that which app a participant receives will not be based on~     any characteristic or behavior of the participant, but will be determined solely by chance~     like a flip of a coin.~   "
28058|NCT03199729|"~     The long-term objective of this research is to develop an efficacious training paradigm to~     enhance older adults' defense mechanisms against falls and possibility reduce healthcare~     cost. The Centers for Disease Control and Prevention estimates the direct medical cost for~     fall related injuries to be $30 billion annually. Slips and trips combined account for more~     than 50% of the outdoor falls in community-dwelling older adults. These environmental~     perturbations are opposing in nature, with slips mainly resulting in backward falls and trips~     in forward falls. This project explores perturbation training through both slip and trip~     exposure based on the principles of motor learning. The project design consists of a~     randomized controlled trial to examine the ability of the central nervous system to mitigate~     the interference in stability control (if any) that is induced by opposing types of~     perturbations. It also introduces a novel combined slip and trip perturbation training~     paradigm to enhance one's ability to retain and generalize the acquired fall-prevention~     skills to both types of falls. Slips and trips induced on an over ground walkway will be used~     to prepare the motor system to improve stability control and vertical limb support to resist~     falls. The longer-term benefits of such combined perturbation training over exclusive~     slip-only or trip-only perturbation training in reducing both laboratory-induced and real~     life falls will also be assessed. The hypothesis of this study if supported by the results~     will provide an evidence-supported training protocol to reduce the fall-risk among~     community-dwelling older adults.~   "
28059|NCT03199716|"~     The study aim is to determine if parent mentors can improve adherence to the intensive~     multiple daily injection regimen (MDI) or the insulin pump therapy, through monitoring the~     frequency of blood glucose measurements. Researchers are also trying to determine if the~     parent mentors can improve glycemic control, which is measured through HbA1c. The study~     hypothesis is that trained parent mentors can help families with children who have poorly~     controlled T1DM improve adherence to their diabetes regimen and improve their metabolic~     control.~   "
28060|NCT03199703|"~     This will be a prospective single-blinded, randomized, controlled trial comparing the~     effectiveness and safety of transseptal puncture using the Baylis transseptal system to~     transseptal left atrial access with standard transseptal equipment (usual care) in patients~     undergoing catheter ablation procedures for atrial fibrillation with the cryoballoon system.~      The targeted population will consist of patients with symptomatic paroxysmal atrial~     fibrillation undergoing pulmonary vein isolation with the cryoballoon system.~   "
28061|NCT03199690|"~     The purpose of the study is to see how the drug Dolutegravir is broken down by your body,~     when taken with another drug called Rifampicin. Dolutegravir is given to people as a~     treatment for HIV. Rifampicin is given to people as a treatment for tuberculosis.~   "
28062|NCT03199677|"~     This is a single-center, open-label, single arm，exploratory clinical trial evaluating the~     efficacy and safety of Apatinib in patients with local progressive/metastatic refractory~     thyroid cancer.~   "
28063|NCT03199664|"~     The study will compare the effectiveness of combined treatment with NB-UVB and tacrolimus~     versus NB-UVB alone . Patients will be treated for 6 months and followed up after 3 months~     .All types of vitiligo will be included except universal vitiligo.~   "
28064|NCT03199651|"~     This randomized clinical trial studies the Beating Lung Cancer in Ohio protocol in improving~     survival in patients with stage IV non-small cell lung cancer. The Beating Lung Cancer in~     Ohio protocol may help in evaluating immunotherapies and targeted therapies that prolong~     survival, have more favorable toxicity profiles than conventional chemotherapy and impact~     quality of life.~   "
28065|NCT03199638|"~     This project will assess the feasibility and efficacy of the use of exercise and dietary~     supplementation with a non essential amino acid - glutamine - a component of most protein~     supplements, on the regulation of plasma glucose homeostasis in a clinical setting of~     children with type 1 diabetes (T1D). The study specifically targets patients in puberty as~     this period is associated with a physiological decline in insulin sensitivity, the latter~     often associated with poor control. Although physical exercise has long been known to exert~     beneficial effects on metabolism, lack of time is the most common reason perceived as~     preventing the performance of exercise in both healthy and diabetic subjects. In earlier~     studies, we showed that oral supplementation with glutamine, a non essential amino acid given~     prior to exercise decreases overnight post-exercise blood glucose in adolescents with T1D.~     Hence, the objective of the current study is to investigate if a novel way of exercising,~     such as performing 6 short bouts of just 1 min each of intense exercise ('exercise snacks')~     30 min before meals, with or without glutamine, improves glycemic control in adolescents with~     T1D. Designing innovative ways to improve diabetes control in adolescents is highly~     desirable. The specific aim of the project is to determine whether the sustained use of the~     proposed exercise snacks with or without glutamine results in diminished glycemic variability~     and/or improved glucose control~   "
28077|NCT03199482|"~     A Comparative Evaluation of the effect of pretreatment dexamethasone versus placebo on~     post-endodontic pain and success of inferior alveolar nerve block in Mandibular molars with~     symptomatic Irreversible Pulpitis: A Blinded Randomized Clinical Trial Therapeutic study~   "
28078|NCT03199469|"~     This is a Phase 1/2, multinational, open-label, ascending-dose, delayed-treatment concurrent~     control clinical study to evaluate the safety and preliminary efficacy of AT132 in subjects~     with X-Linked Myotubular Myopathy aged less than 5 years old. Subjects will receive a single~     dose of AT132 and will be followed for safety and efficacy for 5 years~   "
28091|NCT03199300|"~     Cisplatin, anthracyclines, bleomycin and trastuzumab can cause severe cardiovascular or~     pulmonary toxicity. Why some patients are susceptible to extreme toxicity of cancer treatment~     is largely unknown. Unraveling extreme cardiovascular toxic responses in cancer patients may~     help understand the pathophysiology of cardiovascular toxicity of these agents and help in~     understanding the more subtle, long-term cardiovascular side effects that affect a larger~     part of cancer survivors. With induced pluripotent stem cells we will obtain patient-derived~     cells to recapitulate and mimic and study pathological (cardiovascular) responses and~     (cardiovascular) toxicity in vitro.~   "
28066|NCT03199625|"~     Cognitive behavioral therapy (CBT), which includes cognitive therapy (CT) and behavioral~     therapy (BT), is the first-line treatment for patients with panic disorder (PD). However, the~     neural mechanism of CBT is unknown. The exploration of mechanism is of great significance for~     clinical strategy formulation. This study is proposed on the basis of our early PD and CBT~     neuroimaging studies, adopt the design of prospective randomized controlled intervention~     study, set up three time points: before the treatment（week 0）, the initial treatment (week~     4th), the plateau treatment (week 28th). With normal subjects as black control and~     antidepressant therapy as intervention comparison, this study set up CT and BT two~     intervention groups, respectively collect all the participants'symptomatological,~     psychological, cognitive function and brain imaging data (3D,DTI, fMRI in resting and tasks~     states) at week 0, week 4th and week 28th. This study is based on the advanced analysis~     methods we applied in the early study,including BOLD-fMRI, DTI, topological characteristics~     analysis of the whole brain network and Granger causality test etc. It is from the point of~     multiple levels(brain regions, circuits, whole brain), multimodal (structure, function) to~     comprehensively analysis the role of CT and BT for the function and structure of brain~     regions, circuits (mood regulating circuit and cognitive control network for emotion~     processing) and whole brain in patients with PD. Totally, we explore the target area, path~     and mechanism of CBT for emotion processing neural circuits in patients with PD, and combined~     with the clinical data we preliminarily explore the imaging biomarkers of different~     intervention methods which may predict therapeutic effect.~   "
28067|NCT03199612|"~     The advent of continuous flow (CF) pumps for patients with severe heart failure has led to~     marked improvements in survival; however, pump operation remains fraught with adverse~     thrombotic events. This climbing rate of thrombosis and stroke during CF pump support has led~     to a recent warning by the US Food and Drug Administration. Despite a rising incidence of~     pump thrombosis and its downstream complications of stroke, the hematologic mechanisms behind~     these devastating adverse events remain uncertain. Recently, it has been recognized that CF~     pump induced hemolysis precedes and is associated with thrombosis. In-vitro studies show~     increased platelet function with exposure to products of hemolysis, which is also known to~     occur in diseases of intravascular hemolysis such as sickle cell anemia. This proposal will~     investigate if hemolysis associated increased platelet function can be reduced by a~     potentiation of nitric oxide signaling by an oral phosphodiesterase-5 inhibitor, sildenafil.~     Elucidating mechanisms of hemolysis induced thrombosis may inform best strategies for~     prevention of end organ damage and maintaining optimal CF pump operation.~   "
28068|NCT03199599|"~     Prospective validation of a prognostic model based on advanced PET/CT image analysis in non~     small cell lung cancer~   "
28069|NCT03199586|"~     First-in-human phase 1 study to determine safety of NP-G2-044 when given orally on a daily X~     28 days followed by a 14 day rest period.~   "
28070|NCT03199573|"~     The proposed study will assess the current sun safety policies and practices in programs for~     young children and to determine the willingness of stakeholders to incorporate more~     protective measures.~      The primary hypothesis is that children in Head Start programs, daycare programs, elementary~     schools, or summer camps are exposed to significant UV radiation throughout the day, and are~     not adequately protected with sunscreen, hats, or sun-protective clothing. The secondary~     hypothesis is that these programs value sun safety as an important health behavior, but~     probably do not have the funding avilable to make it a priority.~   "
28071|NCT03199560|"~     A randomized controlled double-blinded study comparing the intraoperative injection of~     lymphatic mapping agents Tc 99m tilmanocept to Tc 99m filtered sulfur colloid in breast~     cancer patients undergoing breast conservation and sentinel lymph node biopsy~   "
28072|NCT03199547|"~     Though maternal and neonatal health are high priority areas for international development,~     maternal and neonatal mortality remain unacceptably high. Worldwide there are 1 million~     maternal and 4 million neonatal deaths every year and half of them occur in sub-Saharan~     Africa.~      Post-partum and neonatal severe bacterial infections, namely sepsis, are leading causes of~     maternal and neonatal deaths in sub-Saharan Africa. Newborns can be infected during labour -~     when passing through the birth canal - and also during the first days/weeks of life, as a~     consequence of the close physical contact with the mother, when the latter carriers bacteria.~     As the mother is an important source of bacterial transmission to the newborn, treating~     mothers with antibiotics during labour should decrease their bacterial carriage and therefore~     lower transmission to the newborn. As carriage is a necessary step towards severe disease,~     this intervention should in turn result in the lower occurrence of severe bacterial disease~     and mortality during the neonatal period.~      In many high-income countries, pregnant women are screened during pregnancy for vaginal~     carriage of Group B Streptococcus, the bacteria responsible for the vast majority of neonatal~     sepsis in the developed world. If women are carriers, they are treated with intravenous~     antibiotics during labour to decrease the risk of severe disease to their off-spring.~     Although this intervention has been successful in developed countries, infrastructure and~     resource limitations in regions like sub-Saharan Africa prevent both screening and use of~     intravenous antibiotics. Also, in Africa several bacterial pathogens are responsible for~     neonatal sepsis and the antibiotics needed in the continent should cover a wider number of~     bacteria; and ideally cover also bacteria responsible for severe post-partum disease in the~     mother.~      We will conduct a large trial in West Africa, The Gambia and Burkina Faso, with the main~     objective of determining if a single dose of an oral antibiotic given to women during labour~     decreases newborn mortality. The trial will also assess the effect of the antibiotic on~     lowering newborns and maternal hospitalization during the first week's post-partum. We have~     selected an antibiotic (azithromycin) that in sub-Saharan Africa has already been used for~     elimination of other prevalent diseases such as trachoma. This antibiotic is safe, requires a~     single oral administration, has no special storage requirements and has the potential to~     eliminate most of the bacteria commonly causing severe disease in newborns and post-partum~     women in the continent. Very important this antibiotic is not widely used in clinical care in~     the continent, and therefore, any temporal increase of resistance induced by the intervention~     should not have implications on current treatment guidelines.~      Before going to the large trial proposed here (12,500 women to be recruited), we have~     generated robust preliminary data on the effect of the intervention in a proof-of-concept~     trial conducted in The Gambia (829 women and their offspring recruited). We found that in~     fact, babies born from mothers who had taken this antibiotic during labour were less likely~     to carry bacteria that can potentially cause severe disease. These babies were also three~     times less likely to have bacterial skin infections or umbilical infections, both highly~     common among African newborns. Besides, fever or mastitis (again both very common in the~     region) during the post-partum period were four times lower among mothers who had taken the~     antibiotic during labour. Such trial confirmed our hypothesis of impact on bacterial~     transmission but it was too small to assess the effect of the antibiotic on mortality and~     hospitalizations. The preliminary trial also showed that women from the azithromycin group~     were less likely to need antibiotics for treatment infections during the puerperal period,~     decreasing then the pressure on the scarcity of antibiotics available in the continent.~      The advantages of our approach are its simplicity, low cost and the possibility of protecting~     both mothers and babies with the same intervention.~   "
28073|NCT03199534|"~     This study assesses whether the addition of chemodenervation to an established regimen of~     pelvic floor physical therapy for painful high tone pelvic floor dysfunction improves~     patients' objective and subjective outcomes. Study subjects will select one of three~     treatment approaches: injection of 50 units Botulinum toxin A with local sedation as an~     office procedure, injection of 100u BoNTA-cosmetic in either the office or while~     anesthetized, or injection of 150 units Botulinum toxin A while anesthetized.~   "
28074|NCT03199521|"~     This study will assess the effect of apixaban on thrombotic status in patients with atrial~     fibrillation.In addition it will compare apixaban to aspirin and warfarin on their effect on~     endogenous fibrinolysis.~   "
28075|NCT03199508|"~     Nocturnal enuresis is common problem in children who are from 5 to 18 years old and do not~     spontaneously urinate at least 2 times a week for more than 3 months. It can lead to major~     distress for the children and their parents. The investigators hypothesize that the 3-day~     voiding diary as the same as the 7-day voiding diary could be a diagnostic tool to provide~     information on the diagnosis and classification of nocturnal enuresis. The purpose of this~     study is to investigate the reliability and sensitivity of 3-day versus 7-day voiding diary~     to diagnose nocturnal enuresis.~   "
28076|NCT03199495|"~     Contrast to conventional Western medicine, traditional Chinese medicine is the most common~     used therapy of complementary and alternative medicine. Taiwan inherits traditional Chinese~     culture, and the people popularly accept traditional Chinese medicine for general diseases.~     However, most patients with acute or critical illness are used to admit to emergency~     department for medical services, and then transfer to the department of related specialist~     for further treatment. During the course of staying at emergent observation room, some~     diseases do not meet the criteria of admission and keep for evaluation. The longer of staying~     at emergent observation room the more waste medical resources.~      The Chinese medicine department of Changhua Christian hospital has treated patients, who~     consulted us at their own dispense, with subjective discomfort but remained at the emergent~     observation room. Detailed contents of this study include the Chinese and Western medicine,~     pharmaceutical, nursing cooperation mode, monitoring clinical effect of treating of the~     patients diagnosed with intestinal obstruction or ileus who complain about nausea, vomiting,~     abdominal pain, abdominal distension or constipation.And the patients were assigned to the~     control and treatment group. Then we give the treatment group with the electroacupuncture~     treatment,and the control groupe with the Chinese medicine seeds and the transcutaneous nerve~     stimulation (no power).The patients were diagnosed with objective analysis of tongue~     diagnosis, pulse diagnosis, heart rate variability, and questionnaire of pain. Hope that we~     can assess the efficacy of both two different treatment,and also assess the cost of medical~     care, and try to complete the syndromes statistical analysis of traditional Chinese medicine~     for abdominal pain, building the relevance of Chinese medicine physical assessment teaching~     and clinical efficacy.~      The most important of this clinical teaching is that, this is a good opportunity for Chinese~     medicine and Western medicine to cooperate with each other at the emergency department to~     confirm the efficacy of traditional Chinese medicine, not only in the field of chronic or~     geriatric diseases, but also in the field of emergency with the evidence base. This factually~     achieves communication and integration of Chinese and Western medicine, and benefits the~     public.~   "
48407|NCT02933320|"~     The purpose of this study is to identify the tolerable dose of BI-1206 for patients with~     B-cell lymphoma and leukaemia and further evaluate BI-1206 alone and in combination with an~     anti-CD20 antibody~   "
28079|NCT03199456|"~     The Zip-009 clinical investigation will enroll 26 paediatric subjects requiring laceration~     repair and fulfilling the eligibility criteria for the clinical investigation. The~     investigation is designed to evaluate the time and cost savings and the satisfaction and~     outcomes of the Zip 4 device compared to conventional sutures. The subjects will be randomly~     assigned at a 1:1 ratio to either the Zip 4 Surgical Skin Closure Device group or the~     Standard of Care sutures group. The investigation consists of one screening/baseline visits~     at day 0 where the subject will be treated with either the Zip device or sutures, and~     thereafter two follow up telephone calls at day 10 and day 30. The Zip device/sutures will be~     removed prior the first follow up call day 10. The duration of the investigation is estimated~     to 5 months, including a 4-month recruitment period and 1-month follow up period.~   "
28080|NCT03199443|"~     Prospective observational study.~      A substantial number of patients do not respond favourably to sacral neurostimulation (SNS)~     although clinically, they appear to have the same lower urinary tract (LUT) dysfunction~     characteristics as the good responders. This may be due to methodological issues (lead~     position) or patient selection. The purpose of this study is to improve and standardize lead~     position, in order to increase the patient response to test stimulation and to SNS treatment,~     and to decrease adverse events.~   "
28081|NCT03199430|"~     The aim of this study was to explore the impact of acute ingestion of the polyphenol~     epigallocatechin galate (EGCG) on catecholamine, catecholamine metabolite, systemic metabolic~     and cardio-vascular variables across a range of exercise intensities during graded cycle~     exercise in man.~   "
28082|NCT03199417|"~     Randomized controlled trial regarding the efficacy of a multimodal topical analgesic,~     Multiprofen, in comparison to placebo cream treatment on knee pain and function in patients~     with knee osteoarthritis.~   "
28083|NCT03199404|"~     This purpose of this retrospective, single-arm, non-randomized, multi-center study is to~     collect real-world data on the effectiveness of using the TRAP technique in acute ischemic~     stroke patients undergoing mechanical thrombectomy.~   "
28084|NCT03199391|"~     The purpose of this study is to collect postmarket data in subjects who receive surgical~     treatment of a full-thickness rotator cuff tear (of at least 1.5 cm) with the BioWick™~     SureLock™ implant. Both performance and safety data will be collected.~   "
28085|NCT03199378|"~     The goal of this proposal is to collect normative data from a sample of ethnically diverse~     Florida elders on a brief, standardized neuropsychological test battery . The norms collected~     in this multi-cultural dataset will provide appropriate corrections for demographic and~     sociocultural variables that contribute to performance variance on neuropsychological tests.~     By accounting for these variables, the normative corrections will improve specificity and~     eliminate disparities in diagnostic validity and clinical utility of neuropsychological tests~     when administered to Florida's ethnic minority elders.~   "
28086|NCT03199365|"~     The goal of this research study is to learn about factors that may affect healthy eating and~     physical activity for Latino families in Houston. Researchers will use this information to~     design a program to encourage healthy behaviors.~   "
28087|NCT03199352|"~     The technique of laparoscopic Roux-en-Y gastric bypass (RYGB) has evolved significantly over~     the past few decades to minimize complication risks such as strictures. Three different~     anastomotic techniques are currently widely used hand-sewn (HS), linear-stapled (LS) and~     circular stapled (CS). Studies are contradictory as to the best technique to avoid~     complications. Many studies have focused on the stricture and infection rates of these~     procedures, and minimized the examination of ulceration, gastritis, and anastomotic leak. The~     purpose of this study is to prospectively examine how the use of linear-stapled and hand-sewn~     anastomotic techniques affect complication rates of marginal ulceration, gastritis, leak and~     stricture in patients who undergo RYGB. The goal of this study is to compare the long-term~     complication rates between hand-sewn robotic RYGB and linear-stapled laparoscopic RYGB.~     Eligible patients are men and women age 19-65 who are to undergo RYGB, have a BMI between~     35-45, and RYGB is the primary procedure. The main outcomes to be measured are complications~     in marginal ulceration, gastritis, leak, and stricture rate at 2 and 6 weeks, and 3, 6, 9,~     12, and 24 months postoperatively.~   "
28088|NCT03199339|"~     The primary objective of the study is to evaluate the safety and tolerability of single and~     multiple doses of TBA-7371 in healthy subjects~   "
28089|NCT03199326|"~     This study evaluates the feasibility, acceptability, and impact of a collaborative care~     practice for infants investigated by state Child Protective Services (CPS) for suspected~     maltreatment. Recognizing the vulnerability of infants referred into CPS in the first year of~     life, as well as the frequent contact of infants with health care providers in the first year~     of life, the investigators will conduct a RCT to measure the impact of a collaborative~     practice model linking CPS caseworkers with primary health care providers during an~     investigation for suspected infant maltreatment. With this trial, the investigators will ask~     (3a) Can a collaborative practice model improve parent-reported infant health-related quality~     of life 6 months following child welfare involvement for suspected infant maltreatment? and~     (3b) Does a collaborative practice model impact repeat child welfare involvement for~     suspected child maltreatment over 6 months?~   "
28090|NCT03199313|"~     This is a randomized, double-blind, placebo-controlled, single ascending dose study conducted~     at one study center in the United States. Four (4) cohorts of 8 subjects each (6 active and 2~     placebo). Subjects will participate in only one cohort.~      Safety will be assessed throughout the study; serial ECGs and serial blood samples will be~     collected for the safety and PK assessment of sutezolid.~      Dose escalation to the next cohort (i.e., dose level) will not take place until the Sponsor,~     in conjunction with the Principal Investigator, has determined that adequate safety,~     tolerability and PK from the previous cohort has been demonstrated to permit proceeding to~     the next cohort.~      Interim PK analyses will be performed for the dose escalation decisions to reconsider the~     sampling time points as the study progresses. All samples will be sent for analysis and the~     bioanalytical lab will be unblinded and only run the analysis on active treatment subjects.~     Data from the analysis used for the escalation meetings will only include active treatment~     subjects, and will be blinded by subject.~      Subjects will be housed in the clinic from at least 24 hours prior (from Day -2), until 48~     hours (Day 3) after dosing. Subjects will be contacted via a phone call for follow-up~     questioning about adverse events 7 days later (Study Day 10).~   "
28092|NCT03199287|"~     Infective endocarditis (IE) is an infection of cardiac valves. IE mainly involves bacteria,~     more rarely fungi. IE is an uncommon diseases with an estimated incidence of 1-12 cases per~     100,000 inhabitants per year. The diagnostic of IE relies on the culture of biological~     samples (blood cultures and per-operative samples) in the bacteriology laboratory in order to~     identify the pathogen and its susceptibility to antimicrobials. Nonetheless in about 10% of~     the cases, the blood cultures remain negative, due to antibiotics taken before harvesting, to~     non-culturable bacteria or to aseptic phenomena.~      Clinical metagenomics is defined as the application of high-throughput sequencing (NGS)~     followed by a specific bioinformatics analysis to obtain clinical information, i.e. pathogen~     identification and the prediction of their susceptibility to antimicrobials. The metagenome~     of a sample (i.e. all the genomes of the organisms present) virtually contains all the~     information necessary for bacteriological diagnosis: what is the pathogenic bacteria , and to~     which antibiotics it is susceptible.~      Hence, using clinical metagenomics in the context of IE appears seducing in order to overcome~     the limitations of conventional methods based on culture. Here, we propose to assess the~     performance of clinical metagenomics in the diagnostic of IE.~   "
28093|NCT03199274|"~     This randomized pilot clinical trial studies how well perflutren protein-type A microspheres~     and contrast-enhanced ultrasound work in improving response to radioembolization therapy in~     patients with liver cancer. Ultrasound contrast agents, such as perflutren protein-type A~     microspheres, use gas microbubbles to improve image quality. Using contrast-enhanced~     ultrasound imaging will pop these microbubbles and cause tumors to become more sensitive to~     radiation therapies.~   "
28094|NCT03199261|"~     Evaluation of the pharmacokinetics and safety rE-4 Injection versus rE-4 Freeze-dried Powder~     in healthy subjects.~   "
28095|NCT03199248|"~     Digital mucous cysts (DMCs) are a benign rubbery cystic lesion which usually involve the~     dorsal or lateral side of DIP joint (digital interphalangeal joint) or proximal nail fold.~     The most successful treatment way is surgical management. However, which may cost time,~     require expertise, may cause infection, prolong wound healing and sometimes may lead to the~     joint movement limitation. The investigator bring this new technique: percutaneous~     capsulotomy for digital mucous cysts, which is easy and quick, last but not least, low~     recurrence rate.~   "
28096|NCT03199235|"~     The objective of the study is to assess the acceptability, feasibility, and barriers to Lucky~     Iron Fish™ (LIF) utilization among families with young children in a Latin American community~     with a high prevalence of iron deficiency and iron-deficiency anemia.~   "
28097|NCT03199222|"~     A common problem for the intermediate preparatory stage of prosthetic rehabilitation is~     distal pressure, due to commonly compromised sensation and lack of understanding how to~     address it in a newly fitted prosthesis. Excessive pressure can lead to severe skin~     breakdown, infection, surgical revision, re-hospitalization and delayed rehab. To prevent~     this common problem among rehabilitating amputees, smart socket technology has been developed~     to better identify problems that may occur. The Smart Socket Technology including Prompting~     (SST+P) in this pre-clinical project proposal provides a step activity monitor and senses~     distal pressure, which is novel to the technology. When excessive pressure is sensed on the~     residual limb, it will send a signal to the user's smart phone to make an adjustment. This~     prompting improves patient interaction and may prevent problems as a result of common volume~     fluctuation and compromised sensation. The purpose of this clinical trial is to determine if~     the ALPS iForce smart socket technology with prompting (SST+P) will improve patient~     interaction, usability, comfort, fit, function and health economy outcomes compared with the~     standard of care (SOC) clinical practice protocols of fitting prosthetic socket interfaces~   "
28098|NCT03199209|"~     The goal of this research study is to learn if participating in a program with another family~     member in their household can help participants eat healthier and become more physically~     active.~   "
28099|NCT03199196|"~     The goal of this research study is to learn if enrolling in a program with a partner that~     involves monitoring each other's physical activity and providing support to one another can~     help both participants be more physically active.~   "
28100|NCT03199183|"~     Takayasu arteritis(TA) is a chronic progressive vasculitis predominantly affecting the aorta~     and its major branches. The demographic, clinical and prognostic features of Takayasu~     arteritis in China remains in uncertainties. Investigators aim to setup a national~     registration study for Takayasu arteritis, to observe the prevalence, clinical~     manifestations, natural history, survival, progression, diagnostic and therapeutic methods of~     the disease in China.~   "
28101|NCT03199170|"~     Cesarean section commonly induces moderate to severe pain for 48 hours. These patients have~     additional compelling reasons to provide adequate pain relief as early mobilization is a key~     factor to prevent the risk of thromboembolic event which is increased during pregnancy.~     Beside these, patients need to be pain free to takecare for their newborn and breastfeed~     them. Poorly controlled pain after cesarean section also increases risk of chronic pain and~     postpartum depression.~      Intrathecal morphine is considered the gold standard for postoperative pain relief after~     cesarean delivery. The duration of analgesic effect of morphine extend to 12-24 hours. Its~     widespread use is due to its favorable pharmacokinetic profile, ease of administration and~     low cost. Although intrathecal morphine is highly effective, its use is associated with~     undesirable adverse effect particularly nausea, vomiting and pruritus which reduce overall~     patients' satisfaction. More serious complication is the risk of delayed maternal respiratory~     depression.~      The Quadratus Lumborum block was first described in 2007 which demonstrates a spread to the~     paravertebral space, thus leads to a more extensive block to T5-L1 nerve branches and a long~     lasting block with the potential to provide visceral pain relief. Therefore, this block has~     an evolving role in postoperative analgesia for many lower abdominal surgeries. As the safety~     is concerned, there has been one report of a patient with unilateral hip flexion and knee~     extension weakness leading to unplanned overnight admission following lateral quadratus~     lumborum block after laparoscopic gynaecological operation.~      If the result favors effective, it will have the advantage of a combination with intrathecal~     opioid to prolong the pain free period after cesarean section which has about 4,000 cases per~     year.~   "
28102|NCT03199157|"~     The investigators designed a prospective randomized study to investigate the effect of~     fentanyl 12 mcg transdermal patch on postoperative pain following unilateral, single-level~     laminectomy/discectomy.~   "
28104|NCT03199131|"~     Chronically elevated pulmonary pressures do not immediately result in right ventricular~     failure. During the initial period of exposure, the RV adapts to the increased afterload by~     altering its metabolism and morphology so as to meet the increased work requirement. Several,~     interconnected adaptive mechanisms have been proposed, including myocyte hypertrophy, a~     switch in the primary fuel used for ATP generation, increased angiogenesis, and decreased~     production of mitochondrial reactive oxygen species. While adaptation is initially successful~     in many cases, it is temporary, and after an uncertain period of time, the ventricle begins~     to fail. This transition from a compensated to decompensated state is difficult to predict~     clinically, and patients with different etiologies of CPOS progress to overt RV failure over~     significantly different time periods. This variability hinders the implementation of~     treatments that are tailored to a specific disease stage.~   "
28105|NCT03199118|"~     This research will be conducted in an attempt to achieve complete root coverage with~     physiologic probing depth and a harmonious view with the adjacent tissues using Platelet rich~     fibrin in conjunction with Coronally advanced flap and subepithelial connective tissue graft.~   "
28106|NCT03199105|"~     Catheter-related bladder discomfort (CRBD) is not uncommon in male patients under general~     anesthesia, and it may cause patient agitation and exacerbated postoperative pain. In this~     study, the investigators will enroll male patients undergoing elective noncardiac surgery~     with urinary catheterization after anesthetic induction, and compare preoperative education~     with cartoon illustrations combined with local tetracaine mucilage vs. local tetracaine~     mucilage alone in alleviating CRBD during the post-operative period.~   "
28107|NCT03199092|"~     The purpose of the present study is to compare the effectiveness of Rhythmic Reading Training~     (RRT), a computer-assisted intervention method that combines sublexical reading exercises~     with rhythm processing, and that of a multimodal intervention comprising different~     methodology, called 'Abilmente'. All interventions were delivered for a period ranging 1-2,5~     months, in 60 minutes biweekly sessions.~   "
28108|NCT03199079|"~     Preterm birth is a leading global cause of neonatal mortality despite of numerous advances~     and intensive research in perinatal medicine. Almost one million children die each year due~     to complications of preterm birth and in almost all countries with reliable data, preterm~     birth rates are increasing. Of the 14 million survivors per year, many face a lifetime of~     disability, including learning disabilities, visual and hearing impairments. Spontaneous~     preterm delivery (SPTD) is often multi factorial event, precocious cervical softening,~     shortening and dilatation are a common denominator. The majority of preterm births happen~     spontaneously, though some are due to early induction of labor or cesarean birth, typically~     due to medical maternal of neonatal conditions.~   "
28109|NCT03199066|"~     The Czech National Lymphoma Registry (NiHiL) was founded to monitor epidemiologic data and~     improve the diagnostic evaluation and quality of treatment of patients with non-Hodgkin´s~     lymphoma (NHL).~      The patients are registered into the registry in anonymized form. For each patient are~     available: registration form, diagnostic form, treatment form, follow- up form, and other~     malignancy form.~      Data quality in the NiHiL has been checked by audits. The data is analyzed according to NHL~     subtypes with endpoints: lymphoma distribution, epidemiological data, prognostic~     characteristic, treatment characteristics, response rate, relapse rate, mortality, PFS, OS,~     DFS, Lymphoma specific survival, longterm toxicity.~   "
28110|NCT03199053|"~     The purpose of this research study is to evaluate the efficacy and safety of the drugs~     dapagliflozin and saxagliptin in patients with Type 2 Diabetes who are aged 10 to below 18~     years old and are currently taking metformin, insulin, or both drugs.~      Dapagliflozin and saxagliptin are both approved for use in patients with Type 2 Diabetes aged~     18 years or older. This study will assess how well dapagliflozin and saxagliptin work by~     finding out how these treatments affect blood glucose (sugar) levels compared to placebo (a~     pill that contains no active drug), in children and adolescents. Dapagliflozin and~     saxagliptin are considered investigational products in this study since while they have been~     approved for use in adults (patients 18 years or older), they haven't been approved for~     children and adolescents due to lack of clinical studies in this specific population.~      Patients with Type 2 Diabetes have higher levels of blood glucose (sugar) than patients who~     do not have this disease. The high level of sugar in the blood can lead to serious short-term~     and long-term medical problems. The main goal of treating diabetic patients is to lower blood~     glucose to a normal level. Lowering and controlling blood glucose help prevent or delay~     complications of diabetes, such as heart disease, kidney, eye and nerve diseases, and the~     possibility of amputation.~      Dapagliflozin is a drug that helps to reduce blood glucose (sugar) levels by helping the~     kidneys to remove excess glucose from the blood and excrete it in the urine. It prevents the~     kidneys from returning glucose from the urine back into the bloodstream.~      Saxagliptin increases insulin production when blood glucose levels are high. Insulin is a~     hormone made by the pancreas that allows the body to use sugar (glucose) from the food that~     is eaten for energy or to store glucose for future use. Saxagliptin helps to improve blood~     sugar levels in response to a meal and between meals if blood glucose levels are not lowered~     effectively. Saxagliptin does not work when the blood glucose is low. Saxagliptin also helps~     to decrease the amount of sugar made by the body. Together, these processes reduce blood~     glucose levels and help to control Type 2 Diabetes.~      Dapagliflozin (alone or in combination with other antidiabetic drugs) has been shown to be~     effective in lowering blood glucose in adults with Type 2 Diabetes and is available for use~     in adults (patients 18 years or older) in approximately 40 countries worldwide including the~     USA and Europe. Dapagliflozin has not yet been studied in children (pediatric patients).~      Saxagliptin (alone or in combination with other antidiabetic drugs) has been shown to be~     effective in lowering blood glucose in adults with Type 2 Diabetes and is available for use~     in adults (patients 18 years or older) in approximately 90 countries worldwide. Saxagliptin~     also has not yet been studied in children (pediatric patients).~      The subject will either receive one of the active study drugs or a placebo (a pill that looks~     identical but contains inactive drug). This study will be double blind; this means that~     neither the subject, nor the study doctor will know which treatment the subject will receive.~      Which treatment the subject receives is decided by a computer, purely by chance; this is~     called a random assignment.~      For this study, there will first be a screening phase of up to 6 weeks, followed by a 2 week~     lead in phase. Thereafter there will be a 26 week short-term treatment phase (week 1-week~     26), and a 26 week long-term treatment phase (week 27-week 52). Following this there will be~     a follow-up telephone call on week 56 and a post study visit at week 104.~      At day 1 visit after the lead in phase the subject will be randomly assigned to receive one~     of 3 treatments: dapagliflozin 5 mg, saxagliptin 2.5 mg or placebo in a blinded manner. This~     treatment will continue up to week 14. Then after week 14, and until the end of the study,~     the subject will be assigned to receive one of the following 5 treatments: dapagliflozin 5~     mg, dapagliflozin 10 mg, saxagliptin 2.5 mg, saxagliptin 5 mg or placebo in a blinded manner.~     The drugs assigned after week 14 will be the same drugs as at Day 1, but some of the groups~     will receive them at a higher dose.~      After completion of the 26-week short-term phase, the subject will enter a 26 week long-term~     phase. The same treatment that the subject had been assigned to at week 14 visit will be~     continued. This long-term phase is primarily designed to provide additional information on~     how well dapagliflozin and saxagliptin are tolerated.~      Following the treatment phases, there will be a follow-up telephone call at week 56.~      The subject will be asked to visit the clinic at week 104 again for a final evaluation of the~     physical development (based on the stage of puberty).~   "
28111|NCT03199040|"~     This is a single institution, open-label randomized phase 1 trial of neoantigen DNA vaccine~     alone vs. neoantigen DNA vaccine plus durvalumab in triple negative breast cancer (TNBC)~     patients following standard of care therapy. Patients with newly diagnosed clinical stage~     II-III TNBC are eligible for enrollment. Patients will receive standard of care therapy~     including chemotherapy, surgery and radiation therapy as clinically indicated. Following~     standard of care therapy, patients will be randomized to receive either a neoantigen DNA~     vaccine alone, or a neoantigen DNA vaccine + durvalumab.~   "
28112|NCT03199027|"~     Following the announcement of the global 90-90-90 strategy, there is a huge need in South~     Africa for effective well-developed scaled-up models of ART (anti-retroviral therapy)~     delivery that aim to improve patient adherence and viral suppression. The ART adherence club~     is one such model of service delivery. The investigators are conducting a pragmatic~     randomised control trial to compare virological outcomes 12 months post-ART initiation~     between arms: individuals referred to the Adherence club at 4 months post-ART initiation~     (early referral) and individuals referred to the Adherence club at 12 months post-ART~     initiation (delayed referral). Individuals with delayed Adherence club referral will continue~     to attend the ART clinic as per the Standard-of-Care.~   "
28113|NCT03199014|"~     The purpose of this study is to determine whether prolonged inflation time on drug-eluting~     stents deployment for ST-elevation myocardial Infarction was better than conventional stents~     deployment.~   "
28114|NCT03199001|"~     Fabry Disease (FD) is a rare, X-linked lysosomal storage disorder leading to left ventricular~     hypertrophy, myocardial fibrosis, arrhythmia and heart failure. Cardiac involvement is the~     leading cause of death in FD. Treatment with enzyme replacement therapy is expensive, may be~     poorly targeted and there are difficulties in early detection and disease monitoring. T1~     mapping signal change is a potential remarkable biomarker for FD.~      Fabry400 is a multicentre study aiming to understand the biology of Fabry Disease and its~     relationship to non-invasive multi parametric mapping by CMR.~   "
28115|NCT03198975|"~     Microvascular invasion (MVI) has been well demonstrated as an unfavorable prognostic factor~     for hepatocellular carcinoma (HCC), and patients with MVI have a high risk of tumor~     recurrence after curative hepatectomy. Currently, the diagnosis of MVI is determined on the~     postoperative histologic examination, which greatly limits its influence on preoperative~     decision making. Therefore, we constructed this prospective study to develop a machine~     learning-based model for preoperative prediction of MVI by extracting high-dimensional~     magnetic resonance (MR) image features.~   "
28179|NCT03198143|"~     This study evaluates the effect of the hunger hormone ghrelin on human decision-making.~     Participants will be given an injection of ghrelin or saline on different study days and will~     then be asked to make a series of computer-based decisions. The investigators hypothesize~     that ghrelin will increase participant's preference for energy-dense foods and will also~     increase impulsiveness in decision making.~   "
28116|NCT03198962|"~     There are two stages in the study. In Stage 1, 2000 Thai MSM, MSW and TGW/TGSW will be~     screened at the Thai Red Cross Anonymous Clinic (TRCAC) or Besides walk-in clients of TRCAC,~     potential participants could be referred to TRCAC by Rainbow Sky Association of Thailand~     (RSAT), Service Workers In Group (SWING) Foundation and Sisters Foundation. Each participant~     will complete a short standardized questionnaire on risk behavior, including use of~     amphetamine-type stimulants (ATS) and other drugs. HIV testing will be done following usual~     HIV testing and counseling (HTC) guidelines. Stage 1 will collect data on ATS use in the~     community. The results from stage 1 will also be used to stratify participants for inclusion~     in stage 2 of the study.~      Participants from the screening will be invited to participate in stage 2 of the study, which~     is the longitudinal cohort study. Recruitment will be stratified by HIV status and ATS use as~     listed in to ensure an adequate number of ATS users for data analysis. Participants in stage~     2 will follow-up every 6 months for 18 months.~   "
28117|NCT03198949|"~     This is a prospective, randomized, double-blind, placebo-controlled cross over study designed~     to evaluate the efficacy and safety of everolimus (trough 5-15 ng/mL) given as adjunctive~     therapy in patients with focal cortical dysplasia type II who already failed more than two~     antiepileptic drugs and surgery.~      This study will assess the impact of everolimus to placebo on seizure frequency in focal~     cortical dysplasia type II. The number of patients who experience seizure reduction of 50% or~     more will be counted during last 4 weeks of each core phase.~   "
28118|NCT03198936|"~     Brain Pill™ is a mental health enhancing and successfully marketed dietary supplement.~   "
28119|NCT03198923|"~     The purpose of this study is to assess the safety and effectiveness of natural killer (NK)~     cell and natural killer T (NKT) cell-based immunotherapy in subjects with non small cell lung~     cancer.~   "
28120|NCT03198910|"~     The collected data from the Zurich Registry for pulmonary Hypertension (PH) are evaluated in~     a retrospective analysis. This study examines the number of patients and their exact~     diagnoses who are treated at the University Hospital of Zurich and potentially other~     participating in the Zurich Registry. Other demographic parameters such as age, gender and~     body-mass-index are also part of the evaluation. Furthermore, the analysis will focus on the~     newest guidelines on PH. Therefore, it will be checked how many patients would fulfill the~     therapeutic goals in terms of New York Heart Classification (NYHA), 6-minute walk distance,~     sign of right heart failure and N-terminal pro-brain-natriuretic peptide(NTproBNP).~     Additionally, the study examines on how the patients are treated. Despite the different kind~     of Drugs, the focus lies on the combination therapy (single, double, triple) and the impact~     the therapy had on the patients.~   "
28121|NCT03198897|"~     Development of a new MS-based biomarker for the early and sensitive diagnosis of homozygous~     familial Hypercholesterolemia from plasma~   "
28122|NCT03198884|"~     A Retrospective Study to Evaluate the Safety and Efficacy of a Nucleoside-Sparing Regimen of~     Darunavir, Ritonavir, and Dolutegravir~   "
28123|NCT03198871|"~     Number of patients with unsatisfactory pain relief defined as average visual analog scale~     (VAS) more than 5 with or without requirement of IVPCA for pain relief during the first 48~     hours postoperative period will be compared between the two groups and form the primary~     outcome for the study. Postoperative pain intensity will be measured by Visual Analog Scale~     (VAS) with 0- being no pain and 10-being maximum pain and the analgesic efficacy in both~     groups will also be evaluated by the amount of total narcotic consumption (measured with IV~     morphine equivalent doses of analgesics used to provide pain relief).~   "
28124|NCT03198858|"~     CartoUnivu™ module easily integrates into the workflow of PVI with the endpoint of~     unexcitability of the ablation line without prolonging the procedure time. It is associated~     with a marked reduction in fluoroscopic dose when compared to a conventional 3D-mapping~     system.~      The aim of this prospective randomized study is to evaluate during pulmonary vein isolation~     (PVI) for paroxysmal atrial fibrillation (PAF) whether the use of the IIM is: 1. feasible, 2.~     can help to reduce fluoroscopy time and burden and 3. has an influence on the procedure~     duration.~      Study design Prospective, randomized controlled multicenter trial, open label. Randomization~     1:1~   "
28125|NCT03198845|"~     To investigate the effects of video game play therapy in patients with knee osteoarthritis~   "
28126|NCT03198832|"~     Periodontal disease (PD) and diabetes mellitus type 2 (DM2) have the same inflammatory~     etiopathogenesis and demonstrate a bidirectional relationship, for DM2 affects the severity~     of PD, and this may contribute to the overall inflammatory burden of the individual,~     influencing the natural course DM2. The aim of this study is to establish whether individuals~     with DM with or without chronic periodontitis have an increase in oxLDL and what is the~     influence of periodontal treatment in the reduction of oxLDL with consequent improvement in~     Diabetes Mellitus parameters.~   "
28127|NCT03198819|"~     The correct timing and technique of neural tube defect (NTD) repairs significantly decreases~     the morbidity and mortality of NTD cases. However, infections related to the surgery are~     still common. We investigated the effects of topical rifampicin (RIF) combined with routine~     prophylaxis in newborns with open NTD.~   "
28128|NCT03198806|"~     The need to restore water losses resulting from physical activity has become established and~     diffused into international consensus for healthy individuals or high-performance athletes.~     However, the influence of fluid replacement when administered during and after exercise on~     cardiorespiratory parameters, cardiac autonomic modulation, and subjective perceptions of~     effort and pain of individuals with autonomic alterations known as the coronary arteries~     remain poorly understood. In this sense, this study intends to investigate the influence of~     hydration on cardiac autonomic modulation, cardiorespiratory parameters, subjective~     perception of exertion and pain of coronary arteries submitted to aerobic exercise in the~     model of a cardiovascular rehabilitation session. A total of 31 individuals will be recruited~     in this study and will perform four standardized cardiovascular rehabilitation sessions. Only~     in the second and the fourth session will the volunteers be instructed to ingest a quantity~     of water predetermined by the evaluator, based on the loss of body mass measured in the first~     and the third sessions. The outcomes (autonomic modulation, cardiorespiratory variables and~     perceptions) will be evaluated before, during and after exercise. The results of this study~     will enable professionals working with this population to implement awareness strategies on~     the importance of fluid intake in cardiovascular rehabilitation programs.~   "
28129|NCT03198793|"~     Essential hypertension (HTN) is a disease that affects approximately 1 billion individuals~     worldwide. Despite the availability of effective and safe anti-hypertensive drugs, 65% of~     subjects diagnosed with HTN do not have their blood pressure (BP) controlled (<140/90 mmHg).~     The overall incidence of resistant HTN, (defined as requiring 3 or more anti-hypertensive~     drugs, including a diuretic, to control BP) is estimated to be 15% of the hypertensive~     population. Consequently, there is a pressing unmet medical need to develop new classes of~     anti-hypertensive drugs that act on alternative pathways and further control BP and the~     associated cardiovascular risks in subjects.~      The prevalence of HTN in African Americans in the United States is among the highest in the~     world, and HTN is more common in African Americans than in Caucasians. One of the risk~     factors for HTN is sodium sensitivity. There is a higher association of HTN with sodium~     sensitivity in African American subjects and other racial/ethnic groups who are~     overweight/obese.~      Effective agents to treat HTN in this high-risk population are clearly needed.~      This study will be conducted in a hypertensive, overweight subject population of multiple~     ethnic origins in which QGC001 is likely, based on its mode of action, to demonstrate a~     significant anti-hypertensive effect.~   "
28130|NCT03198780|"~     To establish the feasibility of a tool that monitors and motivates people with COPD to~     complete training in mindful pursed-lip breathing to enhance pulmonary rehabilitation at~     home.~   "
28131|NCT03198767|"~     The purpose of this study is to determine if LIK066 taken with a meal containing low~     carbohydrate is associated with less diarrhea compared to a high carbohydrate meal and to~     assess the potential effects of supplements such as psyllium or calcium carbonate on~     alleviating diarrhea associated with LIK066.~   "
28132|NCT03198754|"~     A sample of 60 patients scheduled for HSCT in the treatment of MM will be recruited in the~     weeks to months prior to their hospitalization. Light therapy incorporating ambient~     systematic programmed light illumination (sPI) will be used in patient hospital rooms (during~     scheduled transplant) to control cancer-related fatigue (CRF). The FDA has certified that~     light therapy, like that used in this study, is a low-risk intervention. When admitted to the~     hospital for a stem cell transplant, there will be a light fixture in the hospital room which~     we will be testing to see how it may affect cancer related fatigue, sleep quality, and other~     negative side effects often seen with the transplant and subsequent treatment. The light~     fixture will turn on and off by itself in the morning. There are two treatment arms used in~     the study, each of the arms uses different light intensities. The study treatment received,~     i.e. which of the two lights, will be chosen by chance, like flipping a coin. There is an~     equal chance of being given each study treatment. Participants will not be told which study~     treatment they are getting until after the study is completed. Each light will be turned on~     from 7 AM to 10AM every day during transplantation. While in the hospital assessment of~     fatigue, sleep activity, depression, circadian rhythms, and quality of life will continue~     through the course of hospitalization (14-21 days of treatment, to determine immediate impact~     of sPI), then repeat at one month and three months post-discharge follow-ups (to determine~     lasting effects). Outcomes will be assessed through standardized scales (e.g., FACIT-Fatigue~     Scale) and objective measures (e.g., actigraphy, daysimeter for light monitoring, melatonin~     from urine collection, blood inflammatory markers, all explained below). This trial will: 1)~     be the first randomized clinical trial (RCT) to investigate the effects of sPI to prevent CRF~     and other biopsychosocial side effects of transplant; 2) focus on a distinct, relatively~     homogenous patient population (MM-HSCT patients) with high prevalence of CRF; and 3) explore~     possible circadian rhythm mediation via melatonin analysis and blood analysis. This~     investigation will have major public health relevance as it will determine if an inexpensive~     and low patient burden intervention (sPI) is able to control fatigue associated with medical~     illnesses and related problems.~   "
28133|NCT03198741|"~     Long-term DAPT is recommended after percutaneous coronary intervention (PCI) in patients with~     coronary artery disease. However, antiplatelet therapy may have adverse consequences, the~     most common of which is gastrointestinal mucosal injury with ulceration and bleeding. The~     extent to which an an abbreviated DAPT strategy reduces gastrointestinal mucosal injury has~     not been studied, principally due to the lack of sensitive, noninvasive measurements capable~     of detecting gastrointestinal injury.ANKON® magnetically controlled capsule endoscopy (AMCE)~     is a non-invasive, active controlled system which affords assessment of the stomach and~     entire small intestine.The current randomized study will assess gastrointestinal mucosal~     injury and bleeding via AMCE in patients on three different antiplatelet regimens and~     establish a gastrointestinal mucosal injury scoring system which may prove useful in guiding~     optimal antiplatelet agent usage after PCI.~   "
28134|NCT03198728|"~     This will be a randomized, multicenter, open-label, active-controlled, efficacy, and safety~     study in adult hypogonadal men. The study duration is 12 months (365 days), including a~     90-day, open-label efficacy period and a 9-month (275-day) safety evaluation period.~   "
28135|NCT03198715|"~     The aim of this study is to find out if DS-1040b is safe and tolerable in acute ischemic~     stroke patients with thrombectomy. Four groups will receive different doses of DS-1040b by~     intravenous infusion for 6 hours. Groups with the lowest dose will start. When it is~     determined that each dose is safe and tolerable, the next higher dose will be given to the~     next group.~   "
28136|NCT03198702|"~     In children population with obstetrical brachial plexus palsy (OBPP), shoulder~     musculoskeletal deformity is the main cause of morbidity, with a loss of range of shoulder~     motion, pain and a reduction in social participation. Some uncontrolled studies shows that~     early injections of botulinum toxin (BTI) in the internal shoulder rotator muscles (which~     cause the deformity) are one of the most promising treatment for the prevention of bony~     deformity.~      The main objective of this study will be the evaluation of the effectiveness of BTI in the~     internal shoulder rotator muscles at the age of 12 months in preventing an increase in~     posterior subluxation of the glenohumeral joint in babies with OBPP (evaluated at the ages of~     11 months and 18 months), compared to the Sham group.~   "
28137|NCT03198689|"~     The purpose of this study is to assess feasibility, safety and preliminary efficacy of~     Brentuximab vedotin (Adcetris), a CD30-directed antibody-drug conjugate, in the treatment of~     active diffuse cutaneous systemic sclerosis (dcSSc).~   "
28138|NCT03198676|"~     A safety study to compare the effect of two different formulations of PrEP-001 nasal powder~     when dosed in healthy subjects~   "
28180|NCT03198130|"~     This study is being conducted to compare the relationship of patient response to treatment to~     changes in tumor microenvironment.~   "
28181|NCT03198117|"~     This study including two parts，one part is a randomized clinical trial design，another part is~     a registration study.~   "
28182|NCT03198104|"~     This is a prospective observational study which will recruit up to 100 paediatric~     participants over a period of 30 months to determine whether MRI is as accurate at detecting,~     distinguishing, and monitoring liver disease as current standard of care techniques such as~     liver biopsy and fibroscan.~   "
48430|NCT02933021|"~     This is a study to investigate the functional consequences of paraprotein production in MGUS~     (Monoclonal gammopathy of unknown significance).~   "
28139|NCT03198663|"~     Black young men who have sex with men (BYMSM) are at high risk for contracting and~     transmitting HIV, and represent a priority population for developing effective interventions.~     Within the House Ball community (HBC), a clandestine subculture of the Black gay community,~     HIV is highly stigmatized. This stigma, coupled with high HIV prevalence rates and elevated~     levels of undiagnosed/untreated HIV infection, places BYMSM in HBCs at incredible risk for~     HIV infection. Community-level interventions that target social norms, behavior, and stigma~     in the HBC are sorely needed in order to make a broader impact among BYMSM. Building on prior~     work in the community, this study proposes to launch an innovative~     Effectiveness-Implementation Hybrid Type 2 trial to examine the effectiveness and~     implementation of a community-level HIV prevention intervention (called POSSE) based on~     popular opinion leader (POL) models across two cities with similar HBCs, Chicago and~     Philadelphia. The proposed study has two specific aims: 1) To determine the effectiveness of~     a POL intervention, POSSE, to decrease sexual risk behavior (UAI), STIs and HIV stigma among~     BYMSM in the HBC; and 2) To evaluate the processes, strategies, barriers and facilitators for~     the implementation of POSSE delivered across two distinct metropolitan areas with high HIV~     prevalence among BYMSM and similar House Ball Communities. To examine these aims, the~     investigators will first use social network strategies to identify, screen, and recruit POLs~     (n=75) from the Philadelphia HBC. The investigators will then gather baseline behavioral and~     biological (HIV/STI testing) data in both Chicago and Philadelphia (n=100 BYMSM per city) and~     train the Philadelphia POLs to implement the POSSE intervention. The investigators will~     conduct an implementation-focused process evaluation to assess fidelity to the POSSE~     intervention; number, content, spread, and acceptability of risk reduction messages; age~     appropriateness of the messages; acceptability of the overall intervention; and~     barriers/facilitators to implementation. Next, the investigators will complete follow-up~     assessments every 6 months post- intervention in both cities (n=100 BYMSM per city at each~     assessment point). The investigators will also assess behavior change in those delivering the~     intervention (POLs) at each assessment point. The investigators will conduct~     implementation-focused qualitative interviews with POLs (n=15) and community participants~     (n=30) from Philadelphia. Last, the investigators will implement POSSE in Chicago by~     repeating the steps outlined above, continuing assessments in both cities, and conducting~     qualitative interviews in Chicago.~   "
28140|NCT03198650|"~     This is a multicenter, open-label Phase 1 study of acalabrutinib, a selective and~     irreversible Bruton's tyrosine kinase inhibitor, in Japanese adult patients with advanced~     B-cell malignancies. This study is divided into 2 parts: Part 1 (dose-confirmation phase) and~     Part 2 (dose-expansion phase).~   "
28141|NCT03198637|"~     The main objectives of the prolonged resuscitation paralysis are usually adaptation to~     mechanical ventilation, lower insufflation pressures and cough suppression.~      The use of monitoring during the prolonged neuromuscular blockade is the subject of~     recommendations. Its interest is subject to a recommendation grade B and its use in~     prevention of overdose is associated with a recommendation of Grade C.~      However, many practitioners continue to objectify the depth of neuromuscular blockade and~     reversal by simple clinical evaluation. This is a subjective estimate of the depth of~     neuromuscular block.~      Resuscitation in several pharmacokinetic parameters are taken into account. First, the drug~     distribution volume is usually increased in the Intensive Care patient and requires an~     increase in initial doses to obtain the same pharmacological effect.~      Then, unlike a short-term administration, the administration of neuromuscular blocking agents~     on days causes diffusion in peripheral compartments. Their diffusion coefficients are slower~     which contributes to the increase of the elimination period after interruption of the~     administration of curare. There is therefore a risk of residual paralysis.~      Secondarily, the curare needs can be influenced by thermoregulation, water and electrolyte~     disorders and acid-base, administration of certain drugs, the inter- and intra-individual~     variability and tachyphylaxis (form tolerance of particularly rapid installation during a few~     close administration, linked to the proliferation of cholinergic receptors).~      The value of monitoring neuromuscular blockade in intensive care is the prevention of~     overdose and in finding the lowest effective dose.~   "
28142|NCT03198624|"~     This is a single and multiple dose, parallel group study to assess safety and~     pharmacokinetics of oral HTL0018318 in healthy Japanese and Caucasian subjects.~   "
28143|NCT03198611|"~     Objectives: To study the prognostic value of the evolution of diastolic function according to~     fluid balance in patients admitted to the ICU with a diagnosis of septic shock, in terms of~     mortality (ICU and hospital) and mortality at 90 days.~      2.4. Secondary objectives: A) Incidence and reversibility of myocardial dysfunction (left~     ventricular systolic and diastolic) in septic shock.~      B) Incidence and reversibility of diastolic dysfunction according to the echocardiographic~     criterion used.~      C) Incidence and reversibility of right ventricular systolic dysfunction.~   "
28144|NCT03198598|"~     In this study the investigators will evaluate the effects of yoga practice on multiple~     sclerosis patients and healthy controls for fatigue, quality of life, movement, cognition,~     brain activity, self-efficacy, stress, anxiety, depression, affective states and~     immunological response. To investigate the effects of yoga training delivered by a yoga~     instructor or through a smartphone application, the investigators will use a multidimensional~     approach that comprises of: evaluation of neuropsychological, quality of life and affective~     aspects, structural and functional magnetic resonance imaging, functional near infrared~     spectroscopy (fNIRS) combined with movement analysis (gait, strength, balance etc.) and~     analysis of the immune response.~   "
28145|NCT03198585|"~     To assess the effect of Empagliflozin on cardiac biomarkers, cardiac function at rest and~     during stress, cardiac hemodynamics, renal function, metabolism, daily activity level and~     health-related quality of life in stable, symptomatic heart failure patients with reduced~     left ventricular ejection fraction.~      The primary hypothesis is that 3 months' treatment with Empagliflozin 10 mg a day will reduce~     the plasma concentrations of N-terminal pro-brain natriuretic peptide (NT-proBNP).~   "
28146|NCT03198572|"~     The purpose of this study is to evaluate the efficacy and safety of berberine treatment on~     Non-alcoholic Steatohepatitis.~   "
28147|NCT03198559|"~     Antiretroviral therapy (ART) dramatically reduces Human Immunodeficiency Virus (HIV)~     replication leading to restoration of immune function and a near normal life expectancy, but~     treatment is lifelong and there is no cure. The major barrier to a cure is the persistence of~     long lived cluster of differentiation 4 (CD4+) T-cells that contain a silenced form of HIV,~     called HIV latency.~      The purpose of this research is to investigate whether it may be possible to reduce the~     amount of dormant HIV infection in immune cells, by turning on or activating the virus and~     hence force it out of the latently infected memory T cells. This leads to production of HIV~     by the cell, which will either die or will be recognized and eliminated by the immune system.~     As very few T cells are latently infected with HIV, the death of these cells is not expected~     to affect the function of the immune system and further infection of new cells is expected to~     be prevented by ART.~   "
28148|NCT03198546|"~     The third generation of CAR-T cells that target GPC3 (GPC3-T2-CAR-T cell)have been~     constructed and their anti-HCC function has been verified by multiple in vitro and in vivo~     studies.Clinical studies will be performed to test the anti-cancer function by the~     GPC3-T2-CAR-T cells in human HCC patients with GPC3 expression.In this phase I study, the~     safety,tolerance, and preliminary efficacy of the GPC3-T2-CAR-T cell immunotherapy on human~     will firstly be tested.~   "
28153|NCT03198481|"~     The decision making process for stress incontinence surgery is complex. A key gap in the~     literature is how to improve patient preparedness and satisfaction for mid-urethral sling~     (MUS) surgery that is reproducible and low cost. Multimedia can assist in bridging this gap.~     The specific aims of the proposed research: (1) is to develop two videos to counsel patients~     who have elected to undergo a MUS surgery. One video will be created from a patient-centered~     perspective using peers as counselors. The second will employ a traditional counseling~     approach; (2) To compare the impact of multimedia counseling between women randomized to a~     patient-centered counseling versus a traditional counseling video. The investigators will~     recruit patients who present with stress urinary incontinence who elect to undergo a MUS~     procedure. Women will be randomized during their pre-operative visit to watch the~     patient-centered or traditional counseling video before they are counseled regarding their~     upcoming MUS surgery in the usual manner. The investigators anticipate women randomized to a~     patient centered-video will report higher satisfaction, less decisional regret, greater~     preparedness, and less anxiety as measured by validated scales. Successful completion will~     improve understanding of patient's needs and will allow development of improved educational~     tools readily available to the AUGS community.~   "
28154|NCT03198468|"~     This study is a prospective, single-arm, multi-center, pilot trial of Bronchoscopic Thermal~     Vapor Ablation for Lung Cancer (BTVA-C) in patients with primary lung cancer or metastatic~     cancer in the lung. Patients who have consented to participate in this study (enrolled) will~     be subject to eligibility screening and baseline assessments, prior to undergoing the BTVA-C~     procedure. Only patients that meet all of inclusion criteria and none of the exclusion~     criteria will receive vapor ablation treatment.~      Patients will receive BTVA-C treatment followed by standard-of-practice surgical resection.~   "
28155|NCT03198455|"~     Asthma and allergy is increasing in Norway and Western countries. Treatment is still mostly~     symptomatic. Extracts of the immunomodulatory and edible mushroom Agaricus blazei, such as~     Andosan™, have been shown to protect against asthma and allergy in murine models by changing~     the T helper cell 1(upregulation)-T helper cell 2 (downregulation) balance in the immune~     system. Andosan™ is produced in Japan and approved as food (mushroom juice) in Norway. Blood~     donors and possibly patients with pollen-derived allergy and asthma will be included in the~     study.The aim is to examine whether Andosan™ i) has similar clinical effects against allergy~     and asthma in man as it has in mice, and ii) reduces drug use and increases frequency of~     blood donations. Blood donors or patients who are recruited with informed consent will be~     given Andosan™ or placebo orally as add-on treatment to ordinary treatment for 7 weeks during~     the Birch pollen season, and specific IgE will be measured before, during and after the~     intervention, in addition to basophil activation testing and filling out of a questionnaire.~   "
28156|NCT03198442|"~     Breast PET may be able to help in the diagnostic pathway in patients to determine which ones~     need to go on to have a second look ultrasound +/- biopsy and those who need to be sent for~     MRI guided biopsy. This may reduce the need to create more anxiety and uncertainty in this~     group of patients, already extremely stressed by the recent diagnosis of breast cancer.This~     study involves a single trial visit the Royal Free Hospital for imaging. Participants will~     need to lie flat for up to 30 minutes on the PET-CT camera and up to 30 minutes on the MAMMI.~     They will be advised not to take part in this study if they are unable to lie flat on their~     back and their front for this length of time or if they are claustrophobic. They will be~     offered the opportunity to see the PET-CT scanner and the MAMMI before deciding to consent to~     the trial.~   "
28157|NCT03198429|"~     The current cluster randomized trial examines the efficacy of embedding two different~     parenting interventions within child protection services for young children (0 to 4) who have~     been exposed to domestic violence and who are at moderate to high risk for recurrent~     experiences of maltreatment. Interventions are embedded in recognition of the significant~     role played by child protection case workers in identifying families in need of intervention,~     referring/engaging families in intervention, and being able to use information resulting from~     intervention (e.g., reports from the intervention program, observations of parenting~     behaviour changes made as a result of intervention) to improve decision-making in their child~     protection practice. Thus in this trial, ongoing child protection case workers for families~     are randomly assigned to receive professional development training, supervision support, and~     priority client access to parenting interventions in the following four conditions: a)~     embedded mother-child dyadic intervention (Mothers in Mind); b) embedded fathering~     intervention (Caring Dads); c) both mother-child dyadic and fathering intervention; d)~     service as usual.~      Mothers in Mind (MIM) is a dyadic mother-child intervention aimed at preventing child~     impairment resulting from exposure to domestic violence. Intervention focuses on increasing~     mothers' awareness of the impact that exposure to family violence/trauma may have had on~     their infants and themselves as mothers, helping identify and promote positive parenting~     skills such as sensitivity and responsiveness to infant needs, promoting parental competence~     and emotional closeness and decreasing mothers' social isolation. Mothers in Mind uses an~     attachment and trauma-informed psycho-educational process approach in 12 weekly sessions (10~     group and 2 individual).~      Caring Dads (CD) aims to prevent recurrence of child exposure to domestic violence by~     intervening with fathers. Caring Dads includes 15 group sessions, an individual intake, and~     two individual sessions to set and monitor specific behaviour change goals. Major aspects of~     innovation in the Caring Dads program include the use of a motivational approach to engage~     and retain men in intervention, consistent emphasis on the need to end violence against~     children's mothers alongside of improving fathering; program content addressing~     accountability for past abuse; focus on promoting child-centered fathering over developing~     child management skills; and a model of collaborative practice with child protection.~      Hypotheses are posed for differential outcomes among child protection workers (level of~     randomization) and for children who are the subject of the child protection referral (nested~     within workers). At the level of the individual child (primary outcome) it is hypothesized~     that there will be lower rates of re-referral for children of families on the caseloads of~     child protection workers assigned to the embedded CD, MIM and combined intervention than for~     those on the caseloads of workers in the service as usual condition. At the worker level~     (secondary outcomes), outcomes are hypothesized in two areas: 1) worker skill in~     conceptualizing risk and need in cases of child exposure to domestic violence and 2)~     increased self-efficacy for referring to and collaborating with embedded interventions.~     Specifically, we hypothesized that following training and at 12-month follow-up, workers in~     the CD/MIM intervention and combined CD and MIM condition will have greater case~     conceptualization skills in responding to hypothetical cases as compared to workers in the~     treatment as usual condition. We further hypothesize that assignment to an intervention~     condition will lead workers to report greater self-efficacy for collaborating with embedded~     parenting interventions than workers in the treatment as usual condition post-training and at~     12-months follow-up.~   "
28158|NCT03198416|"~     This is a single-arm study involving the use of a high resolution manometry (HRM) diagnostic~     device that is not utilized in any clinical decision-making processes. All patients scheduled~     for DISE as part of their regular clinical care will be screened for enrollment via described~     inclusion and exclusion criteria.~   "
28159|NCT03198403|"~     The study aims to investigate the effect of the Popliteal plexus block (PPB) on postoperative~     pain after total knee arthroplasty~   "
28160|NCT03198390|"~     Investigators will measure skin barrier function using noninvasive devices and sample their~     skin and blood to study the expression anti-oxidative enzymes, skin barrier proteins and~     inflammatory molecules. These results will be correlated with the disease severity in atopic~     dermatitis patients.~   "
28161|NCT03198377|"~     Purpose~      The purpose of this study is to determine whether application of Transcutaneous Electrical~     Nerve Stimulation (TENS) is effective on habituation to electrical current whether delivered~     at a fixed frequency of 100 Hz or at patterned frequency. The secondary purposes are to~     determine the effectiveness on mechanical pressure pain and the subjective perception of the~     subjects regarding habituation and comfort of the different stimulations.~   "
28162|NCT03198364|"~     Schizophrenia and bipolar disorder are associated with high risk for suicide, yet there are~     few brief interventions that directly target suicide prevention in this large population. The~     goal of this intervention development study is to evaluate the feasibility, acceptability,~     and preliminary effectiveness of a brief intervention called SafeTy and Recovery Therapy~     (START) that is augmented with content delivered on mobile devices outside of the clinic~     setting. The intervention will evaluated in a community urgent care center context as people~     initiate outpatient care, and, if effective, could be deployed in a wide network of such~     centers.~   "
28163|NCT03198351|"~     Primary Objective:~      To evaluate any potential increase in the risk of major birth defects, in the first year of~     life, in teriflunomide-exposed pregnancies.~      Secondary Objective:~      To evaluate the potential effect of teriflunomide-exposure on other adverse pregnancy~     outcomes including any potential pattern of minor birth defects, spontaneous abortion,~     stillbirth, preterm delivery, small for gestational age at birth and at 1 year follow-up.~   "
28164|NCT03198338|"~     The Transversus Abdominis Block (TAP) block is known to be an effective means of reducing~     patient pain after abdominal surgery. In the meantime, the general TAP block has been studied~     in patients who were in the recovery room and the ward after surgery. The purpose of this~     study was to determine the effect of pain reduction and opioid saving effects in patients~     with TAP block in ICU settings.~   "
28183|NCT03198091|"~     This registry is designed to investigate factors affecting the efficacy of Dun Ye Guan Xin~     Ning tablet on patients with stable angina. The potential hypothesis is that Dun Ye Guan Xin~     Ning has a better effect on different subgroup patients with certain characteristics.~   "
28165|NCT03198325|"~     Prospective, open-label, single arm, non-randomized, proof-of-concept study. Eligible~     patients will sign a written informed consent and will be followed-up at screening, baseline~     (ART interruption) and at 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 32, 40, 48 weeks thereafter or at~     ART resumption.~      The study visits will include: general clinical assessment, routine laboratory tests~     including: creatinine, phosphorus, calcium, alkaline phosphatase, AST, ALT, fasting glucose,~     total cholesterol, HDL- and LDL-cholesterol, triglycerides, CD4+ cell count and CD4+/CD8+~     ratio.~      Additional 30 mL of peripheral blood will be withdrawn at study visits for further~     virological, and immunological investigations and for bio-banking purposes.~      During follow-up, the occurrence of two consecutive HIV-1 RNA values >50 copies/mL or the~     occurrence of stage B or C AIDS-defining events or any serious non-AIDS clinical event at~     least potentially related to treatment interruption will be criteria for ART resumption.~      All patients with HIV-RNA<50 copies/mL at week 48 (end of the study) will resume their~     baseline ART regimen.~      The main demographic, clinical and therapy information will be accurately recorded at the~     study visits in an electronic Case Report Form.~   "
28166|NCT03198312|"~     Develop a prospective, multicenter, randomized, open, parallel controlled noninferiority~     clinical trial to evaluate the efficacy and safety of CathiportTM implantable drug delivery~     device~   "
28167|NCT03198299|"~     Using double blind, randomized controlled design to study the short-term therapeutic effects~     of customized arch support insoles on children~   "
28168|NCT03198286|"~     This pilot clinical trial studies how well the Carevive Survivor Care Planning System works~     in improving quality of life in breast cancer survivors. A personalized survivor care plan~     includes a summary of a patient's cancer treatment and a customized survivor care plan and~     may provide beneficial information and resources.~   "
28169|NCT03198273|"~     The aim of the study is to determine the effects of clinical Pilates Exercises on the level~     of pain, functional status, flexibility, static and dynamic endurance of the truncus muscles~     and quality of life in patients with lumbar disc herniation.~   "
28170|NCT03198260|"~     Aims & objectives:~        1. The aim of the study is to find out the influence of fascial manipulation on running~          kinematics among athletes with medial tibial stress syndrome (MTSS).~        2. The objectives of our study are~      i. To use fascial manipulation as a mode of treatment in MTSS. ii. To compare running~     kinematics before and after treatment intervention. iii. To compare pain perception before~     and after treatment intervention.~   "
28171|NCT03198247|"~     The purpose of this study is to test whether adding a treatment using pain neuroscience~     education (PNE) and coping skills training (CST) to usual care, in subjects with knee~     osteoarthritis and pain catastrophizing, who are scheduled for a total knee arthroplasty~     (TKA), is more effective than only usual care. There is a high evidence level of different~     systematic reviews, which support the efficacy of physiotherapy treatments combined with~     behavioural techniques aimed to reduce pain catastrophism, pain and disability in other~     pathologies. The primary aim of that kind of interventions is to help the subjects to~     reconceptualise its own pain understanding and its role on the recovery process, as well as~     promoting an increase of activity and encourage the subject to resume its usual activity~     instead of continuing to avoid it.~   "
28172|NCT03198234|"~     A significant number of patients with hematologic malignancies need a hematopoietic stem cell~     transplant (HSCT) to be cured. Only about 50% of these patients have a fully matched donor,~     the remaining patients will require an HSCT from a mismatched related or unrelated donor.~     Almost 60% of these mismatched donor HSCTs will result in graft-versus-host disease (GvHD),~     which can cause significant morbidity and increased non-relapse mortality. GvHD is caused by~     the donor effector T cells present in the HSC graft that recognize and react against the~     mismatched patient's tissues.~      Researchers and physicians at Lucile Packard Children's Hospital, Stanford are working to~     prevent GvHD after HSCT with a new clinical trial. The objective of this clinical program is~     to develop a cell therapy to prevent GvHD and induce graft tolerance in patients receiving~     mismatched unmanipulated donor HSCT. The cell therapy consists of a cell preparation from the~     same donor of the HSCT (T-allo10) containing T regulatory type 1 (Tr1) cells able to suppress~     allogenic (host-specific) responses, thus decreasing the incidence of GvHD.~      This is the first trial of its kind in pediatric patients and is only available at Lucile~     Packard Children's Hospital, Stanford.~      The purpose of this phase 1 study is to determine the safety and tolerability of a cell~     therapy, T-allo10, to prevent GvHD in patients receiving mismatched related or mismatched~     unrelated unmanipulated donor HSCT for hematologic malignancies.~   "
28173|NCT03198221|"~     This is a prospective randomized study which will be done at main campus Cleveland Clinic.~     The investigators will be comparing the colon cleansing by the Boston Bowel Preparation Scale~     in participants undergoing colonoscopy as an inpatient at our hospital. Participants will be~     randomized to the the standard of care (4 Liter polyethylene glycol based preparation) or a~     low volume bowel preparation (sodium picosulfate, a stimulant laxative, magnesium oxide and~     anhydrous citric acid (SP/MC)). Both agents will either be administered as full dose the~     evening before or as split-dose on the evening before and on the day of the procedure.~   "
28174|NCT03198208|"~     Fentanyl is the most commonly used opioid during anesthesia at Massachusetts General~     Hospital. Compared to other opioids, e.g. sulfentanil and remifentanil, fentanyl's~     pharmacokinetic properties are more problematic as the context sensitive half-time increases~     with duration of fentanyl infusion. This may lead to respiratory complications particularly~     in patients who receive fentanyl for surgical procedures of long duration. Considering the~     common use of fentanyl during surgery and its duration of action that is hard to predict~     during long surgical procedures, we will evaluate the association between intraoperative~     fentanyl dose and postoperative respiratory complications within 3 days of surgery.~   "
28175|NCT03198195|"~     A protocol named as CIP-2015 for patients with Wiskott-Aldrich Syndrome may reduce the rate~     of GvHD.~      The details of the protocal followed with:~        1. Conditioning regimen Busulfan 16 mg/kg in total, Fludarabine 160 mg/m2 in total.~        2. GvHD Prophylaxis:~      Rabbit antihuman thymocyte globulin 7.5 mg/kg post-transplant cyclophosphamide (CY) (50~     mg/kg.d on days +3 and +4) Cyclosporine or tacrolimus, mycophenolate mofetil, on days +5~   "
28176|NCT03198182|"~     The purpose of this study is to evaluate safety, and tolerability of BMS-986036 and the~     effects the drug has on the body~   "
28185|NCT03198065|"~     Since Semm et.al. reported the first case of laparoscopic appendectomy in 1983, minimally~     invasive surgery has become the main stay for treating of many surgical diseases. After the~     booming in the advancement of surgical instrument and breakthrough in surgical skills, the~     minimally invasive surgery has been widely applied to neurosurgery, spinal surgery, breast,~     thyroid, hernia surgery, etc. It has been proved that minimally invasive surgery is safe and~     effective, and further it achieves compatible results and outcomes in oncology and functional~     diseases. Minimally invasive surgery in alimentary tract, known as laparoscopic surgery, has~     been performed in gastric surgery (e.g. gastric cancer, tumor, functional disorders and~     bariatric surgery), hepatobiliary and pancreatic surgery (e.g. hepatectomy, cholecystectomy,~     and pancreatectomy), and colorectal surgery (e.g. colorectal cancer and functional bowel~     disease). Under a superior heritage of surgical skills from Taiwan university hospital, we~     introduced laparoscopic surgery in 1996 and currently, laparoscopic surgery becomes the~     mainstay of surgery in Yunlin branch. In 2015, there were 600 laparoscopic surgery in our~     hospital, while 150 colorectal laparoscopic surgery in the same year. In recent years,~     single-incisional laparoscopic surgery has emerged to become one of the focused topic in the~     world and seemly in our department. Through single-incision surgery, we attempted to minimize~     the incision wound to achieve better cosmesis and faster recovery. By the valuable clinical~     experiences gathering in our hospital (Yunlin branch) in recent 10 years, we contemplate~     two-step plans: first, by retrospective data collection, we can explain the clinical problems~     based on current statistical results. Second, based on prior (step 1) retrospective findings,~     a prospective study could be conducted for more evident results.~   "
28186|NCT03198052|"~     The third generation of CAR-T cells that target PSCA, MUC1, PD-L1, or CD80/86 have been~     constructed respectively and their anti-cancer function has been verified by multiple in~     vitro and in vivo studies.Clinical studies will be performed to test the anti-cancer function~     of the these individual or combination of the CAR-T cells for immunotherapy of human cancer~     patients with PSCA, MUC1, PD-L1, or/and CD80/86 expressions.In this phase I study, the~     safety,tolerance, and preliminary efficacy of the PSCA/MUC1/PD-L1/CD80/86-CAR-T cell~     immunotherapy on human cancers will firstly be tested.~   "
28187|NCT03198039|"~     The primary purpose of this trial is to test the feasibility of implementing a meditation~     program in the perioperative period.~   "
28188|NCT03198026|"~     This phase II trial studies how well obinutuzumab and ibrutinib work as front line therapy in~     treating patients with indolent non-Hodgkin's lymphoma. Monoclonal antibodies, such as~     obinutuzumab, may interfere with the ability of cancer cells to grow and spread. Ibrutinib~     may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~     Giving obinutuzumab and ibrutinib may work better in treating patients with non-Hodgkin's~     lymphomas.~   "
28189|NCT03198013|"~     The purpose of this study is to evaluate the safety, PK, PD, of BMS-791826 and to assess its~     marker specific PD in relation to Prednisolone in healthy male subjects~   "
28190|NCT03198000|"~     This is a single center, double-blinded study designed to demonstrate the therapeutic~     equivalence of over-the-counter eye drops in healthy adults with red eyes.~   "
28191|NCT03197987|"~     Colonoscopy is the gold standard investigation for the diagnosis of bowel pathology and~     colorectal cancer screening. Adenoma detection rate is a marker of high quality colonoscopy.~     In this study we compare two devices: Endocuff (TM) and cap that can increase the adenoma~     detection rate during colonoscopy.~   "
28192|NCT03197974|"~     The aim of this study is to improve outcomes in people with bipolar disorder (BD) by~     comparing two new online interventions specifically designed to improve quality of life~     amongst people who have had multiple (10 or more) episodes of BD.~   "
28193|NCT03197961|"~     This study is a biphasic steady state pharmacokinetic and pharmacodynamic study of TFV and~     FTC in healthy women comparing the drug levels and activity in the absence (first phase) and~     then the presence (second phase) of DMPA. The investigators will recruit 12 healthy women~     aged 18-45 who are HIV-negative and at low risk for acquiring HIV.~   "
28194|NCT03197948|"~     This pilot clinical trial studies how well electronic patient reported outcomes work in~     measuring health-related quality of life in patients with stage I-IV prostate cancer~     undergoing treatment. Using a smartphone application to measure and monitor symptoms before,~     during, and after treatment may help patients better detect, understand, and manage their~     health.~   "
28195|NCT03197935|"~     This is a global Phase III, double-blind, randomized, placebo-controlled study designed to~     evaluate the efficacy and safety of neoadjuvant treatment with atezolizumab (anti-programmed~     death-ligand 1 [anti-PD-L1] antibody) and nab-paclitaxel followed by doxorubicin and~     cyclophosphamide (nab-pac-AC), or placebo and nab-pac−AC in participants eligible for surgery~     with initial clinically assessed triple-negative breast cancer (TNBC).~   "
28196|NCT03197922|"~     This study is comparing 2-week and 1-week versions of a multidisciplinary intervention for~     encopresis (MIE), consisting of both medical and behavioral components to treatment as usual~     control (TAU). Participants are first screened by a pediatric gastroenterologist and assessed~     and treated for any constipation or other potential medical complications. Following this,~     caregivers collect data on bowel movements and continence during a home baseline lasting no~     less than 14 days and no more than 21 days. Participants randomly assigned to one of the~     treatment groups start attending daily appointments in clinic for either 1 week or 2 weeks.~     At appointments, the behavior team implements structured sits on the toilet to promote~     independent bowel movements (BMs). If an independent BM does not occur, the study team will~     administer a suppository to promote rapid release of the bowels and prompt the child to~     remain on the toilet following administration. In doing so, continent bowel movements are~     predictably evoked while the child is on the toilet, allowing for reinforcement with praise~     and preferred toys/activities. Eventually, suppositories are gradually decreased until the~     child is having BMs independently. Caregivers are trained to continue implementing the~     intervention following the clinic-based portion.~      The purpose of the current study is to evaluate MIE using a large randomized clinical trial~     (RCT), addressing the Department of Defense Autism Research Program, Area of Interest of~     Therapies to Alleviate Conditions Co-Occurring with autism spectrum disorder (ASD). The~     researchers will recruit 150 children diagnosed with ASD, randomizing them to 2 weeks of MIE~     , 1 week of MIE, or treatment as usual (TAU) consisting of behavioral consultation and~     medical intervention. This study will evaluate MIE compared to TAU and determine the optimal~     treatment length.~   "
28197|NCT03197909|"~     Chronic Obstructive Pulmonary Patients is a defined by persistent airflow limitation that is~     usually progressive and associated with an enhanced chronic inflammatory response in the~     airways and the lung to noxious particles or gases. It is associated with an atrophy of the~     skeletal muscle that impairs the patient's prognosis. The biological mechanisms of this~     muscle atrophy have not been elucidated, and the spill-over theory has recently emerged.~     Indeed, in COPD patients, the pulmonary inflammation is associated with a systemic low-grade~     inflammation, and the increased pro-inflamatory molelcules in the blood - which constitute~     the cellular micro-environement of the muscle fibre - could activate the mechanisms of the~     cell atrophy.~   "
28198|NCT03197896|"~     This clinical trial studies how well an educational intervention works in increasing~     knowledge about prostate cancer in high-risk neighborhoods. Learning about prostate cancer~     and the pros and cons of screening for prostate cancer may increase knowledge about prostate~     cancer while decreasing anxiety and concerns about prostate cancer screening.~   "
28205|NCT03197805|"~     The American Society of Clinical Oncology (ASCO) and the /College of American Pathologists~     (CAP) recommend that HER2 status (negative or positive) must be determined in all patients~     with invasive breast cancer. The knowledge of HER2 status will help the oncologist in~     prescribing or not a HER2-targeted therapy to patients. Presently, two main methods are used~     to assess HER2 status: immunohistochemistry (IHC, protein expression) and in situ~     hybridization (ISH, gene expression) in order to classify tumor sample as positive, negative~     or equivocal. When a tumor is classified HER 2+ by IHC method, a second test is performed~     using ISH methods (FISH, SISH, CISH). In case of HER2 equivocal result with ISH method (4~     ≤HER2 gene number copy <6), the patient is eligible to an anti-HER2 therapy after discussed~     during MD-MM. This decision should be individualized on the basis of patient status~     (comorbidities and prognosis) and patient preferences after discussing available clinical~     evidence.~      Based on molecular classification, RNA expression could help to discriminate breast cancer~     subtypes (luminal A, luminal B, HER2-overexpressed and triple negative). Prosigna is a~     genomic test, developed by NanoString® based on the PAM50 gene signature, which measures the~     expression of 50 genes to classify tumors into 1 of 4 intrinsic subtypes and could allow~     determining the HER2 status.~      This study was designed in order to define if such a test could help the oncologist to define~     the better therapeutic decision in a HER2 equivocal population. In addition, concordance~     tests will be performed. The aim of this study is to assess the modification decision rate~     between the first and the second multidisciplinary decision-making meeting in HER2 equivocal~     patients using genomic testing.~   "
28206|NCT03197792|"~     The investigators aim to evaluate the utility of portal vein pulsatility as a predictor of~     the composite outcome of persistent organ dysfunction plus death in patients undergoing~     elective or urgent pulmonary endarterectomy for thromboembolic pulmonary hypertension. The~     investigators' hypothesis is that the portal vein pulsatility fraction, measured using~     transesophageal echocardiography immediately after weaning of cardiopulmonary bypass, is~     proportional to the risk of developing subsequent end-organ dysfunction in the postoperative~     setting.~   "
28207|NCT03197779|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and~     pharmacodynamics following increasing doses of 2 h (Part A) and 5 day (Part B) continuous IV~     infusions of BMS-962212 in healthy subjects across the expected pharmacodynamic dose range.~   "
28208|NCT03197766|"~     The intent and design of this Phase 3 study is to assess BMN 111 as a therapeutic option for~     the treatment of children with Achondroplasia.~   "
28209|NCT03197753|"~     The aim of this prospective, randomised, controlled clinical trial was to compare immediate~     postoperative discomfort, emergence delirium and recovery time of the patients intubated~     using either laryngeal mask airway or nasotracheal intubation.~   "
28210|NCT03197740|"~     The objective of this study is to evaluate the efficacy and safety of donepezil transdermal~     patch in patients with mild to moderate Alzheimer's disease.~      The primary objective is to demonstrate the non-inferiority of the test drug, IPI-301~     (donepezil transdermal patch), to the comparator, Aricept tablet, after 24 weeks of treatment~     in patients with mild to moderate Alzheimer's disease in terms of improvement in cognitive~     function as assessed by the Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) and~     in terms of global assessment as assessed by Clinician's Interview Based Impression of Change~     plus Caregiver Input (CIBIC-plus).~   "
28211|NCT03197727|"~     This study compares the associated risk factors between adults with tooth wear and age- and~     sex-matched controls without tooth wear.~   "
28212|NCT03197714|"~     Phase Ib, open-label, dose-escalation clinical trial to evaluate the best-tolerated doses in~     Acute Myeloid Leukaemia (AML) relapsed or refractory to chemotherapy.~      This open-label, nonrandomized trial will comprise 2 stages. A dose escalation stage will~     characterize the safety, tolerability and maximum tolerated dose (MTD), of OPB-111077.~      Subsequently, an expansion stage will further evaluate the safety and antitumor activity of~     OPB-111077 in AML relapsed or refractory to chemotherapy.~      Enrollment to the expansion cohort will begin following determination of the MTD.~      Approximately 6-12 patients will be included in the phase I part of this clinical trial.~      Additional patients will be included in the expansion cohort up to a total of 15 patients.~     The expansion cohort will serve to further evaluate safety simultaneously with preliminary~     efficacy.~   "
28213|NCT03197701|"~     The general objective of this project is to determine the best method to measure maximal~     inspiratory flow rates, to study their reproducibility and create reference equations in~     healthy subjects.~   "
28214|NCT03197688|"~     The Opsumit Users registry (OPUS; NCT02126943) was developed to characterize the safety~     profile of Opsumit and to describe clinical characteristics and outcomes of patients newly~     treated with Opsumit in the post-marketing setting. It is expected that the recruitment~     target of the OPUS registry cannot be achieved within the planned time period (5000 Opsumit~     new users by October 2018). The OrPHeUS study is designed to supplement the OPUS registry~     with retrospectively identified first-time Opsumit users in order to achieve the desired~     sample size.~   "
28215|NCT03197675|"~     Of the more than 250,000 Americans with severe spinal cord injury (SCI), 42,000 are military~     veterans. The Department of Veterans Affairs is the largest single network of SCI care~     providers in the nation. Patients with SCI experience functional disabilities as well as~     chronic pain. Studies show that individuals with SCI report pain refractory to conventional~     treatments. Civilian and veteran patients with SCI have associated pain with impairments in~     physical and cognitive function, sleep, employment, social relationships, community~     re-integration and quality of life. In a survey of individuals with SCI, those who used~     acupuncture experienced a reduction of pain symptoms lasting hours after treatment, with~     27.3% reporting pain relief for days. A pilot study on the use of auricular acupuncture for~     neuropathic pain associated with SCI showed a greater reduction of pain as measured by the~     Numerical Rating Scale (NRS). A recent review of randomized controlled trials regarding the~     use of acupuncture in SCI found that only two of sixteen included studies were of high~     quality. There was limited evidence for the use of acupuncture in motor functional recovery,~     bladder function recovery, and in pain control related to SCI. Further high quality studies~     are needed. This proposal is for a phase II randomized clinical trial.~   "
35467|NCT03102359|"~     The investigators investigated in the present study whether selective head cooling and~     dexmedetomidine has an effect on cerebral oxygenation during liver transplantation and has~     cerebral protective effect in patients undergoing liver transplantation.~   "
28216|NCT03197662|"~     The investigators propose a phase 2 randomized double blind 8-week treatment trial of~     intranasal OXT vs. placebo in 50 subjects aged 5 to 17 years with PWS in order to assess~     IN-OXT's affect on measurements of (1) eating behaviors (2) repetitive behaviors (3) weight~     and body composition (4) quality of life (5) salivary OXT and hormone levels (including~     ghrelin, pancreatic polypeptide, peptide YY, GLP-1, insulin, glucagon, testosterone, and~     estrogen). If superior to placebo, this data will add to the current knowledge that OXT is an~     effective treatment for hyperphagia as well as other symptoms of PWS.~   "
28217|NCT03197649|"~     Evaluate mature burn scars before and after treatment with CO2 for patients age 3-21 while~     comparing the treated areas to an untreated control area in the same patient.~   "
28218|NCT03197636|"~     An observational single center study designed to identify response-related biomarkers of~     anti-programmed death 1 (PD-1) therapy to advanced melanoma patients and to investigate if~     vitamin D levels are related to treatment response. 40 patients diagnosed with advanced~     melanoma will be included. Patients are included at the Department of Oncology, Aarhus~     University Hospital (AUH). All patients will be treated with Pembrolizumab as a standard~     procedure at the Department of Oncology. The protocol comprises blood samples at baseline, 3~     and 6 weeks after treatment initiation with anti-PD1 therapy and three years of observational~     follow-up. A total amount of 217 ml blood will be drawn during the study period. The study~     period is 6 weeks followed by 3 years of follow-up. Medical history, symptoms, response to~     treatment regarding the RESIST criteria and side affects will be recorded at each visit in~     both the study period and in follow-up. Biochemical markers will be obtained according to~     normal procedure during study and follow-up visits.~      20 Healthy volunteers (HV) are included, matched by age and gender. Collected blood samples~     (serum, plasma, peripheral blood mononuclear cells) will be analyzed after the last patient~     has ended the week 6 visit.~   "
28219|NCT03197623|"~     A Phase 1 Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose~     Study of the Safety and Tolerability of Intravenous LLP2A-Alendronate in Adult Men and Women~     with Osteopenia Secondary to Corticosteroids.~   "
28220|NCT03197610|"~     Subepithelial connective tissue grafts (SCTG) are accepted as the gold standard in covering~     denuded root surfaces. Combining enamel matrix derivatives (EMD) with periodontoplasic~     surgical operations is another method in covering denuded root surface. The aim of this study~     is to compare a SCTG operation group and EMD applied group in addition to SCTG using complete~     root coverage rate and a newer method root coverage esthetic scoring system (RES).~   "
28221|NCT03197597|"~     This study focus on the genetic changes of B. pertussis clinical isolates. For this panels of~     B. pertussis isolates has been collected during four periods in different European countries.~   "
28222|NCT03197584|"~     This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination~     therapy in subjects with epithelial ovarian cancer who have progressed on or after SoC~     therapy.~   "
28223|NCT03197571|"~     This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination~     therapy in subjects with urothelial cancer who have progressed on or after chemotherapy and~     anti- PD-1/PD-L1 therapy.~   "
28224|NCT03197545|"~     The study is a genetic historical cohort study in a military combat recruits - this study~     does not examine a specific treatment but rather examines a statistical link between medical~     history of traumatic fractures, clinical diagnosis of stress fractures and the presence of~     unique SNPs in subjects DNA.~   "
28225|NCT03197532|"~     Women of late to mid reproductive age may participate in a study using novel methodology to~     identify subtle changes in the reproductive endocrine axis via daily urine hormone analysis,~     which may have important implications for reproduction and may signal reproductive~     senescence.~   "
28226|NCT03197519|"~     The purpose of this project is to conduct a multicentre, randomized controlled trial (RCT)~     with 250 patients diagnosed with an eating disorder (ED). In this experiment, the patients~     from the experimental group will test an mHealth application (TCApp developed by HealthApp)~     and then, a clinical efficacy analysis and economic evaluations will be performed. To do~     this, we have set the following three specific objectives:~        -  To evaluate the clinical efficacy of an intensive intervention that includes both~          standard face-to-face Cognitive Behavioural Treatment (CBT) (treatment as usual, TAU)~          plus an online intervention using TCApp, versus TAU alone.~        -  To carry out an economic evaluation (cost-utility and cost-effectiveness analysis) of~          the new mHealth intervention and identify factors that promote or hinder the~          implementation of TCApp in mental health settings in Spain.~        -  To analyse the adoption processes of this type of applications by patients and health~          professionals and identify the determinants of mHealth adoption.~      General hypothesis:~      The implementation of the intensive intervention program (TAU + TCApp) would result in a more~     significant improvement of the ED symptoms compared to the TAU control group.~      Specific hypotheses:~        -  The application of the intensive mHealth intervention would lead to significantly~          greater change scores (difference between T0 and T1, which will be also maintained at~          follow-up, T2) in the primary outcome variable of ED psychopathology, compared to the~          control group.~        -  The mHealth intervention would lead to significantly greater change scores (difference~          between T0 and T1, which will be also maintained at follow-up, T2) in patients'~          secondary outcome variables: a) depression symptoms, b) anxiety symptoms, c) motivation~          to change, d) suicidal risk, and e) quality of life, compared to the control group.~        -  Similarly, intensive intervention would result in greater change scores (difference~          between T0 and T1, which will be also maintained at follow-up, T2) in caregivers'~          variables: a) quality of life and b) caregiver burden.~   "
28227|NCT03197506|"~     This phase II trial studies the side effects and how well pembrolizumab works in combination~     with standard therapy in treating patients with glioblastoma. Drugs used in the chemotherapy,~     such as pembrolizumab and temozolomide, work in different ways to stop the growth of tumor~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors.~     Giving pembrolizumab and standard therapy comprising of temozolomide and radiation therapy~     may kill tumor cells.~   "
28228|NCT03197493|"~     This protocol is an extension of protocol 0002, Proof of Concept and Dose Ranging Study of~     carbidopa-levodopa in Neovascular AMD. that is a 3 month study of escalating doses of~     carbidopa-levodopa in neovascular AMD. This trial is a 9 month extension for patients who~     successfully complete protocol 0002 and wish to continue carbidopa-levodopa therapy. It will~     use the two higher dose regimens of protocol 0002. these will be assigned according to how~     well the higher dose was tolerated in protocol 0002.~   "
28229|NCT03197480|"~     To investigate whether ocular imaging and proteomic biomarkers; and systemic biochemical,~     metabolomic, and genetic biomarkers predict treatment response to intravitreal aflibercept in~     a cohort of patients with DME.~      To identify if subjects with DME who do not have a rapid response to intravitreal~     aflibercept, will benefit from intravitreal steroid therapy, and identify the biomarkers that~     predict response to steroid therapy.~   "
48441|NCT02932878|"~     An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following~     Treatment with DSXS (Taro Pharmaceuticals U.S.A., Inc.) in Patients with Plaque Psoriasis~   "
28231|NCT03197454|"~     The primary objective of this study is to evaluate the effects of the experimental treatment~     (cognitive training) further outlined in this protocol on the cognitive abilities (e.g.,~     processing speed, attention, working memory, and executive function), brain functionality,~     functional status and quality of life of individuals with age-related cognitive decline as~     compared to a computer-based active control.~   "
28232|NCT03197441|"~     This study aimed to analyze the effect of platelet-rich plasma (PRP) on knee osteoarthritis.~     Eligible patients will undertake arthroscopic knee surgery plus intraoperative PRP and also~     receive second look surgery and intraoperative biopsy.~   "
28233|NCT03197428|"~     This study aims to evaluate the effect of platelet-rich plasma (PRP) on chronic lateral ankle~     instability by comparing the imaging and clinical outcomes between patients receiving PRP and~     those receiving whole blood during the modified Broström-Gould procedure.~   "
28234|NCT03197415|"~     This study aims to evaluate the effect of platelet-rich plasma (PRP) on discogenic low back~     pain by comparing the pre- and post-interventional outcomes in patients receiving intradiscal~     injection of autologous PRP.~   "
28235|NCT03197402|"~     This leucine-enriched protein gummy (as a gummy bar/slab) will be studied to address~     age-related loss of muscle mass and strength/function in older persons. The product is small~     volume (approximately 35 g per serve) and low energy (approximately 100 kcal per serve). It~     is easy to chew and swallow with the consistency of a firm Jello. In addition, it contains an~     effective dose of leucine in a high-quality protein matrix consisting of milk proteins.~     Understanding the efficacy of this product on changes in levels of blood amino acids and the~     molecular signaling required to enhance muscle growth will provide helpful insight for the~     suggestion of supplemental use.~   "
28236|NCT03197389|"~     The study consists of 2 parts: a retrospective study, and a prospective clinical study with~     pembrolizumab (Keytruda®) (Phase 0).~        1. Retrospective study (S58910):~           This is a retrospective analysis to study the expression of PD-L1 in ER/PR negative~          breast tumors and to correlate this PD-L1 expression with tumor infiltrating lymphocytes~          (TILs), proliferation, expression of apoptosis and clinical outcome (development of~          distant metastases).~        2. Phase 0 study:~      This is a Phase 0 single center, open-label, non-randomized, study in patients with early~     ER/PR negative breast cancer. Patients will be treated with one injection of Pembrolizumab~     (Keytruda®) administered intravenously at 200 mg 10 +/- 4 days before surgery. This phase 0~     study will consist of 2 cohorts; cohort A will include patients who are scheduled for upfront~     surgery. Cohort A1 will include patients with Her2 negative tumors and Cohort A2 patients~     with Her2 positive tumors. Cohort B will include patients who received neoadjuvant~     chemotherapy (with anti-Her2 therapy if Her2 positive) and who have clear signs of residual~     tumor on imaging after finishing neoadjuvant chemotherapy (i.e. on imaging estimated residual~     tumor size of at least 10 mm). Cohort B1 will include Her2 negative tumors and Cohort B2 Her2~     positive tumors. The injection will be given in the oncological outpatient unit. Patients~     will be monitored carefully for the development of adverse experiences/events. Adverse~     experiences/events will be evaluated according to criteria outlined in the NCI Common~     Terminology Criteria for Adverse Events (CTCAE), version 4.0.~   "
28237|NCT03197376|"~     This study will examine the consistency of 3 batches of the Pneumosil vaccine by looking at~     the immune response in infants. In addition, the study will compare the immunogenicity of the~     Pneumosil vaccine to another WHO-prequalified vaccine, Synflorix.~   "
28238|NCT03197363|"~     The main goal of the study is to provide a unique multidimensional picture of the health of~     the population with simultaneous optimal standards of sampling, processing and storing of~     data and biomaterial that will allow discovering novel mechanisms in the development and~     progression of common civilization diseases. In the effect it will improve prevention,~     diagnosis and treatment.~   "
28239|NCT03197350|"~     The goals of this research will be to define some of the mechanisms underlying the~     progression and complications of heart failure (HF) with preserved left ventricular ejection~     fraction (HFPEF) Aim 1: to evaluate the differences in cardiac structure, function and~     fibrosis markers through the spectrum of HF stages in order to deepen the understanding of~     the pathophysiology driving HF progression.~      Aim 2: to define the mechanisms by which HF risk factors, such as hypertension, diabetes,~     obesity, and renal insufficiency, interact with age to increase HF risk, and to evaluate the~     role of precipitating factors such as myocardial ischemia, atrial fibrillation in HFPEF.~      Aim 3: to determine prognostic factors in HFPEF patients, by following these patients over~     time. Accordingly the investigators will correlate baseline data (echocardiographic, MRI or~     biomarkers) with incident cardiovascular events and determine whether these measures provide~     incremental prognostic information beyond clinical characteristics.~   "
28240|NCT03197337|"~     Small-scale experiments conducted by our group have led to the hypothesis that Localized~     Provoked Vulvodynia (LPV) may be due to laxity of the Utero-Sacral ligaments (USL). According~     to this hypothesis, the pain experienced by women with LPV is due to the USL's inability to~     provide appropriate support for the pudendal nerve.~      In order to test this hypothesis we will conduct a single-blind randomized control trial in~     which patients with LPV will undergo a pressure-test - pressure will be temporarily applied~     to the posterior fornix using a large-sized applicator, thus strengthening the USL and adding~     support to the pudendal nerve. While the pressure is being applied, the cotton-swab test will~     be performed (palpating vulvar and vestibular sites using a cotton-swab), and each patient~     will rate the elicited pain on a scale of 1 to 10 (1 - not painful, 10 - worst pain~     imaginable).~      The results for each patient will be compared to their baseline level of pain (which will be~     recorded in the beginning of the experiment) and to the level of pain they report while~     inserting a speculum but not applying any pressure.~   "
28241|NCT03197324|"~     The purpose of this study is to examine the drug-drug interaction in your body when given the~     study drug, bexagliflozin, with the heart failure medication digoxin. The study will evaluate~     whether bexagliflozin effects the amount of digoxin in your blood and how safe the study drug~     is and how well the study drug is tolerated when taken with digoxin.~   "
28432|NCT03194828|"~     This study will evaluate the effectiveness of real-time data collected on patients taking~     topical medication to treat glaucoma. Patients will be randomized to two groups, the first of~     which will only use the study device to take their medication, while the second will use the~     study device and receive on-demand reminder messages, when necessary.~   "
28242|NCT03197311|"~     Surgical extraction of third molars is one of the most common outpatient procedures performed~     by oral surgeons. The prescription of postoperative narcotic and NSAID analgesics is the~     standard of care practice to relieve symptoms of pain, swelling, and trismus after these~     procedures. The majority of these patients do not return for follow up unless they experience~     a problem. There is limited data on whether the patients use the narcotics as directed and~     what is their practice of disposal of the remaining medications that were not consumed.~      In this research the effectiveness of postop analgesic consumption, analgesic disposal~     practice, pain control, and patient satisfaction will be compared between patients who are~     randomized to the intervention group who will use a developed mobile application and a~     control group who will not use the mobile app.~   "
28243|NCT03197298|"~     Acute coronary syndrome (ACS) guidelines have been changed, favoring dual antiplatelet~     therapy (DAPT) with the more potent P2Y12 inhibitor ticagrelor over clopidogrel (besides~     aspirin). This change is based on studies that showed benefits of ticagrelor. However, study~     participants were only partly treated by percutaneous coronary intervention (PCI). In~     patients who were treated by PCI, this was generally performed using of bare metal or~     first-generation drug-eluting stents (DES).~      CHANGE DAPT is an investigator-initiated, prospective, single centre registry, in which we~     evaluate the impact of the guideline suggested change in the primary DAPT regimen (from~     clopidogrel to ticagrelor) on 1-year clinical outcome in ACS patients treated by PCI with~     newer-generation DES in the Thoraxcentrum Twente.~   "
28244|NCT03197285|"~     The aim of the present study is to value the effectiveness of an Eye-Cervical Re-education~     Program (ECRP) to decrease pain and increase mobility in the cervical area compared to a~     Combined Physiotherapy Protocol (CPP) in patients with chronic neck pain symptoms.~   "
28245|NCT03197272|"~     To evaluate the improvement in myopic refractive error and the corneal endothelial safety~     with a corneal crosslinking treatment regimen for mild myopia. The treatment involves a 4-mm~     central treatment zone in high oxygen environment without corneal epithelial debridement.~   "
28246|NCT03197259|"~     A prospective, multicenter national observational study for patients diagnosed as chronic~     lymphocytic leukemia across 25 centers in Turkey~   "
28247|NCT03197246|"~     This study will provide further knowledge concerning the use of electrocardiography (ECG)~     signals for verification of peripherally inserted central catheter (PICC) tip placement.~     Furthermore, it will be investigating whether use of Intravascular ECG (IVECG) for this~     verification is just as good as or even better than the current standard method with chest~     X-ray. This can help promote a method that involves less radiation and increased safety for~     patients, while at the same time saving resources. If use of ECG signals from the PICC tip is~     an equally exact method for verification of correct PICC tip placement as chest X-ray~     verification, the IVECG could replace chest X-ray control.~   "
28248|NCT03197233|"~     The objective of this study is to investigate if maternal intake of vitamins A and D from~     food and dietary supplements during pregnancy, and infant supplementation with these~     vitamins, are associated with development of asthma in the offspring.~   "
28249|NCT03197220|"~     : findings have been reported about the benefits of omega-3 fatty acids on decreasing the~     incidence of cardiovascular disease (CVD). The objective was to compared the effects of~     walnut (plant omega-3 fatty acid) and fatty fish (marine omega-3fatty acid) and their~     combination on cardiovascular risk factors. In this clinical trail 99 over weight and obese~     female adults were on three diets with fish (300 g), walnut (6 walnuts) or fish-walnut (150g~     fish and 3 walnuts) for 12 weeks. Three diets were Low in calories and similar. Fasting blood~     sugar, inflammatory markers serum lipids, coagulation factors (fibrinogen, D-Dimer), oxidant~     markers and leptin were measured at baseline and the end of study. Anthropometric indices,~     blood pressure levels, food records were assessed before study and by 3-wk intervals until~     the end of trail~   "
28250|NCT03197207|"~     The plan  Quantitative analysis of different acupuncture needle manipulation to treat~     chronic shoulder pain includes an objective observation of acupuncture operation (movement~     in the form of acupuncture needles, intensity, etc.) and the body (acupoints) reactions.~     Patients during 20-55 years old suffered shoulder pain more than six weeks with numerical~     rating scale (NRS) pain intensity more than 5 points, and the previous month were not taking~     medicine or Western medicine were included. Then use of distal acupoints GB34 and GB39,~     giving once acupuncture manipulation therapy.~   "
28251|NCT03197194|"~     The aim of the THEIA study is to determine if Alteplase administrated within 4.5 hours~     improve visual deficit due to acute CRAO with a good safety profile.~   "
28252|NCT03197181|"~     Motivation represents a core aspect of goal-directed behavior as it determines how much~     effort individuals are willing to invest to reach their goals. While research on effort-based~     decision-making focuses mainly on effort preferences in younger adults, loss of motivation~     might be a key component of the apathetic tendencies frequently seen in older adults.~     However, an open question refers to which brain mechanisms underlie motivational processes in~     older adults. The investigators have recently shown that the frontopolar cortex plays a~     crucial in motivating the exertion of rewarded effort in younger adults. The goal of the~     current study is to determine whether frontopolar cortex plays a crucial role for motivation~     also in older adults and may thus be a promising target for improving the motivation deficits~     in healthy aging. Participants perform computer-based experimental tasks measuring the~     propensity to exert cognitive or physical effort for monetary rewards. During task~     performance, participants receive anodal or sham transcranial direct current stimulation~     (tDCS) over their frontopolar cortex. The study tests whether tDCS over frontopolar cortex~     allows modulating participants' motivation to engage in rewarded effort.~   "
28253|NCT03197168|"~     The principal objective of this pilot trial is to evaluate the effectiveness of a~     psychosocial intervention to reduce self-stigma and improve treatment adherence and quality~     of life among people with a severe mental illness who attend to Community Mental Health~     Centers in Chile. The intervention is based on recovery and narrative therapy and considers~     10 group sessions, mainly with patients, but also integrating relatives and professionals in~     some of the activities.~   "
28607|NCT03192553|"~     Alternative doffing strategies may help prevent self-contamination of staff members when~     using PPE. The study aims to determine which among the suggested methods in the literature~     that have been proposed as alternatives to the traditional CDC recommended doffing protocol,~     would be most beneficial to reduce healthcare worker self-contamination.~   "
28254|NCT03197155|"~     Background and Aims: Arrival of direct-acting antiviral (DAA) agents against hepatitis C~     virus (HCV) with high-sustained virological response (SVR) rates and very few side effects~     has drastically changed the management of HCV infection. The impact of DAA exposure on~     hepatocellular carcinoma (HCC) recurrence after a first remission in patients with advanced~     fibrosis remains to be clarified.~      Methods: 68 consecutive HCV patients with a first HCC diagnosis and under remission,~     subsequently treated or not with a DAA combination, were included. Clinical, biological, and~     virological data were collected at first HCC diagnosis, at remission and during the~     surveillance period.~   "
28255|NCT03197142|"~     The registry enroll all the patients who suffered an out-of-hospital cardiac arrest in the~     Province of Pavia with a follow-up up to five years after the event.~   "
28256|NCT03197129|"~     The amount of time the patient has spent awaiting treatment and the nature of the waiting~     room environment influence the anxiety level prior treatment. The objective of the present~     study is to compare the effect of waiting room's environment on the levels of anxiety~     experienced by children, in sensory adapted dental environment (SADE) and traditional waiting~     rooms.Cross-over randomized trial. The participants will be randomly assigned to one type of~     waiting room for the first visit, and the other type for the second visit. The participants~     will be asked to answer VPT scale while waiting in the waiting room just before entering the~     clinic.~   "
28257|NCT03197116|"~     This is a randomized controlled study to compare the effectiveness of interactive telephone~     reminders by a layperson on enhancing compliance with CRC screening by FOBT, when compared~     with usual care (i.e. no intervention).~   "
28258|NCT03197103|"~     The aim of this study is to assess the effect of new tumescent solution for liposuction~     containing N-Acetylcysteine (Pietruski solution) on the autologous fat graft volumetric~     retention used for healthy women breast asymmetry correction by means of lipofilling.~   "
28259|NCT03197090|"~     This is a single center, open label, randomized control trial to assess the efficacy of a~     one-lead ECG handheld device (Zenicor) for the detection of previously unknown atrial~     fibrillation (AF) in hospitalized patients.~      All patients admitted to the internal medicine department of the Hospital Fribourg throughout~     the study period will be screened for study enrollment. Patients with known or previously~     documented atrial fibrillation, patients with a cardiac pacemaker, and implantable~     cardioverter-defibrillator or intra-cardiac monitoring device will be excluded from the~     present trial. The study population will consist of approximately 800 patients in each group~     at the University of Fribourg Medical Center. Patients must meet all eligibility criteria for~     inclusion into the study.~      Patients allocated to the treatment group will undergo twice daily monitoring with the~     handheld Zenicor ECG. Additional recordings will be obtained whenever patients notice~     palpitations. Recordings will be obtained in the presence of specially trained nurses. The~     recordings will then be validated through a web-based interface offered by Zenicor. The~     one-lead ECGs will be reviewed by the investigating physicians through the Web-based analysis~     service (Zenicor-ECG Doctor System) to assess the presence of atrial fibrillation.~      The primary end point of the study is the percentage of newly detected atrial fibrillation at~     6 months~   "
28260|NCT03197077|"~     The study will focus on important aspects related to follicle recruitment using exogenous~     gonadotropins in patients with polycystic ovaries:~        1. Early follicle recruitment in patients with polycystic ovaries using corifollitropin~          alfa: does administration of this drug result in earlier and higher FSH (follicle~          stimulating hormone) concentrations above the threshold for follicle recruitment in an~          IVM (in vitro maturation) cycle preceded by oral contraceptive suppression, in~          comparison to normal daily administration of rFSH (recombinant follicle stimulating~          hormone, Puregon)?;~        2. The maturation rate of the obtained oocyte-cumulus complexes in standard IVM media~          registered for clinical use: does stimulation with corifollitropin alfa versus~          recombinant FSH have an impact on the maturation rate and developmental capacity of the~          oocytes ?~   "
28261|NCT03197064|"~     The purpose of this study is to determine if intravenous fosaprepitant can interfere with~     nervous system monitoring signals in patients having surgery under general anesthesia. This~     medication has numerous effects on the sensory nerve transmission which can theoretically~     have effects on the ability to accurately measure somatosensory evoked potentials.~   "
28262|NCT03197051|"~     Endothelial glycocalyx, the luminal structure of healthy vasculature, plays critical roles in~     regulation of inflammatory responses, vascular permeability, blood coagulation. It can be~     easily damaged by ischemia/reperfusion, hypoxemia, oxidative stress, endotoxin. Accordingly,~     the relationship between the shedding of endothelial glycocalyx and the prognosis of diseases~     such as diabetes mellitus, atherosclerosis, malignancy has been researched.~      In cases of cardiac surgery, patients cannot help but be exposed to ischemia/reperfusion,~     oxidative stress which can damage endothelial glycocalyx. In this research, the investigators~     would like to discover the impact of perioperative shedding of the endothelial glycocalyx on~     the incidence of postoperative acute kidney injury in patients undergoing valvular heart~     surgery.~   "
28263|NCT03197038|"~     Chronic kidney disease (CKD), affects over 45% of all individuals over 70 years of age.~     Patients with moderate CKD have more than a two-fold increased risk of cognitive impairment~     than those without CKD; furthermore, as many as 20-70% of patients with CKD have established~     cognitive impairment and overt dementia. The burden of cognitive impairment and dementia~     leads to functional decline and accelerated loss of independence, contributing to the~     tremendous individual, societal, and economic burden of CKD (i.e., 20% of Medicare~     expenditures in adults >65 years of age). There is no recommended treatment to prevent~     cognitive decline in CKD patients, and the few medications available for cognitive impairment~     have only short term modest effects. There is a critical need to evaluate therapies to~     forestall cognitive impairment, and maintain or improve cognitive functioning in older~     patients with CKD. To address this need, this study will test the hypothesis that older~     patients with moderate/severe CKD and pre-clinical cognitive impairment randomized to a~     6-month home-based exercise program will improve cognitive function and MRI measured brain~     structure, compared to a usual care control group. This study will combine an assessment of~     cognition with MR imaging techniques to fully evaluate brain structure, blood flow, and~     behavior relationships at a level previously not conducted in this population~   "
28264|NCT03197025|"~     Background:~      Vulvar high-grade squamous intraepithelial lesion (HSIL) is caused by infection of the vulva~     with human papillomavirus (HPV). In a small percentage of cases, vulvar HSIL can turn into~     cancer. The risk of cancer can be reduced by treating HSIL. A personalized immune treatment~     might rid the body of HPV infection and thereby cure vulvar HSIL. The immune treatment in~     this study is called T cell therapy. The cells are E6 TCR T cells. Participants will also get~     aldesleukin (IL-2) to help the cells last longer.~      Objective:~      To find a safe dose of E6 TCR T cells combined with aldesleukin to use in people with vulvar~     HSIL.~      Eligibility:~      Design:~      Participants will be screened with:~      Physical exam~      Medical history~      Blood, lab, and pregnancy tests~      Heart tests~      Chest x-ray~      Sample of tissue taken from the vulva (biopsy).~      Participants will have leukapheresis. Blood will be removed by a needle in one arm. A machine~     removes white blood cells from the blood. The rest of the blood is returned by needle in the~     other arm. The white blood cells will be changed into E6 TCR T cells and grown in a lab.~     About 3 weeks later, participants will be admitted to the hospital for about 5 days. They~     will get the cells through a tube placed in a vein. They will get IL-2 the same way.~     Participants will recover 1-3 days in the hospital. They will be monitored closely. They will~     have blood and lab tests. Participants will have follow-up visits with lab tests and a~     physical exam every few months for 5 years. At some visits they will also have leukapheresis,~     blood tests, or vulvar biopsy.~   "
28265|NCT03197012|"~     This is a prospective, pilot, single center, open-label study in patients with metastatic~     neuroendocrine tumor. Eligible participants will undergo baseline assessments at enrollment.~     Study participants will receive a one-time administration of 90Y-DOTA-TOC via the hepatic~     artery.~      Participants in the correlative sub-study will receive 68Ga-DOTA-TOC concurrent with the~     90Y-DOTA-TOC dose, and undergo additional imaging and assessment.~   "
28266|NCT03196999|"~     The investigators have developed a mobile app called Resolving Psychological Stress (REPS) to~     help alleviate symptoms of PTSD. The app will administer threat-related attention bias~     modification to individuals who score high on a PTSD checklist. This study will be~     administered remotely to individuals in the United States. The aims of the study are to~     explore both the feasibility and acceptability of the app with it's users, as well as,~     explore the efficacy of the app at alleviating PTSD severity.~   "
28267|NCT03196986|"~     This randomized, double-blind, multi-center phase 3 study is aimed to compare the efficacy~     and safety of MIL60 with bevacizumab as first-line treatment when combined with standard~     chemotherapy (paclitaxel/carboplatin) in chemotherapy-naive patients with metastatic or~     recurrent non-squamous NSCLC.~   "
28268|NCT03196973|"~     The purpose of this study is to determine if a combination of an antibiotic plus a~     corticosteroid is safe and effective in treating AOE~   "
28269|NCT03196960|"~     The primary aim of this study is to assess if the mobility dose that patients receive in the~     surgical intensive care unit (SICU) predicts adverse discharge disposition (primary~     endpoint), and muscle wasting diagnosed by bedside ultrasound (secondary endpoint).~   "
28270|NCT03196947|"~     Multicentre, open label, uncontrolled, phase I pharmacokinetic study, to determine the~     Maximum Tolerated Dose (MTD) of APO010 administered intravenously on D1, D8 and D15 followed~     by a one-week drug rest, in patients with multiple myeloma for who have relapsed or are~     refractory to 2 (in high-risk patients 1) or more different prior therapies and who have Drug~     Response Predictor (DRP) for APO010 indicating a higher likelihood for response to APO010.~     The study will contain an extension phase where the recommended Dose will be tested on~     additional patients.~   "
28271|NCT03196934|"~     To allow subjects who have completed Insys 030 extension study to continue to take~     Cannabidiol oral solution.~   "
28272|NCT03196921|"~     This will be an open label phase I/II prospective cohort study to determine the efficacy and~     safety of CAMB for the treatment and prevention of cryptococcal infection.~   "
28273|NCT03196908|"~     To assess the cardiac effects of energy drink brands in healthy volunteers~   "
28274|NCT03196895|"~     Conventional lifestyle modification in the management of type 2 diabetes focuses on weight~     loss, through caloric restriction and exercise, to reduce insulin resistance. This approach~     is limited because some people either do not need to lose weight, do not want to lose weight,~     cannot lose weight, or cannot maintain weight loss over a lifetime. This study proposes to~     evaluate the effectiveness of a lifestyle modification that focuses on reducing post-meal~     blood glucose (BG) elevations instead of weight loss. It works by teaching participants to:~     1) choose low glycemic load foods that do not significantly increase their blood glucose, and~     2) increase their routine physical activity after meals when it can offset post-meal blood~     glucose elevations. The study will also evaluate the role feedback about blood glucose~     fluctuations can play in improving the effectiveness of this program.~   "
28275|NCT03196882|"~     Currently, there is no consensus regarding iron supplementation dose that is most beneficial~     for maternal and offspring health during gestation. This deficit, or excess, of iron~     prejudices the mother-child wellbeing. Therefore the hypotheses are that an iron~     supplementation adapted to values of hemoglobin at the start of the pregnancy will would be~     more effective in preventing iron deficiency, without increasing the risk of~     hemoconcentration by the end of pregnancy. This would be helped optimize mother-child health~     status.~      The aims of the study are to determine the highest level of effectiveness of iron~     supplementation adapted to hemoglobin (Hb) levels in early pregnancy, which would be optimum~     for mother-child health.~      To accomplish this objective a Randomized Clinical Trial (RCT) triple-blinded was designed.~     The study is structured as a RCT with 2 strata, depending on the Hb levels before week 12 of~     gestation.~      Stratum 1: If Hb from 110 to 130 g/L, randomly assigned at week 12 to receive iron supplement~     of 40 or 80 mg/d.~      Stratum 2: If Hb >130 g/L, randomly assigned at week 12 to receive iron supplement of 40 or~     20 mg/d.~      This study will be conducted in non-anemic pregnant women at early gestation stage, and their~     subsequent newborns. The data recollected to mothers will be: socio-economic data, clinical~     history, food item frequency, lifestyle and emotional state, and adherence to iron supplement~     prescription. In addition, biochemical measured will be Hemoglobin, serum ferritin, C~     reactive protein, cortisol, and alterations in the HFE gene (C282Y, H63D). In children, the~     data collected will be: ultrasound fetal biometry, anthropometric measurements, and~     temperament development~      Should conclusive outcomes be reached, the study would indicate the optimal iron~     supplementation dose required to promote maternal and infant health. These results would~     contribute towards developing guidelines for good clinical practice.~   "
28276|NCT03196869|"~     This study is to observe and compare the effect of docetaxel plus lobaplatin induction~     chemotherapy combined with lopoplatin chemoradiotherapy and TPF induction chemotherapy~     combined with cisplatin chemoradiotherapy on dendritic cells subsets in the treatment of~     locally advanced head and neck squamous cell carcinoma.~   "
28277|NCT03196856|"~     This study will analyze the effects of Greek yogurt consumption and an 8 week exercise~     intervention on muscle size, body composition and bone health in untrained, university-aged~     males.~   "
28280|NCT03196817|"~     Carpal tunnel syndrome (CTS) is the most common neuropathic compression syndrome of the upper~     limbs, caused by compression of the median nerve in the wrist. There is no gold standard for~     establishing the diagnosis of STC. The diagnosis can be based on clinical findings and~     electrodiagnostic tests. Treatment options can be divided into surgical and non-surgical~     procedures. Surgical interventions include open carpal tunnel release, mini incision or~     release of the endoscopic carpal tunnel. Nonsurgical include daily activities modification,~     oral anti-inflammatory drugs (NSAIDs), oral corticosteroids, splints, corticosteroid~     injections or other options (laser therapy, ultrasound or acupuncture)~      The aim of this study is to compare randomly, conservative treatment for CTS with night~     splint of the wrist versus local infiltration of corticosteroids after a min-imum period of~     six months follow-up.~      Patients will be divided into two groups: night orthesis group that will receive the~     prescription to purchase the orthesis and guide the use of it; and infiltration group of~     patients will be referred to the Moema Alvorada Hospital to carry out infiltration. These~     patients will be evaluated before application, one week, one month, three months and six~     months after intervention.~   "
28281|NCT03196804|"~     To assess the safety, tolerability and pharmacokinetic characteristics of LC-28-0126 multiple~     iv injection in healthy male subjects.~   "
28282|NCT03196791|"~     This study is designed to evaluate the impact of muscle relaxation during laparoscopic~     gastrectomy on oncological benefit, especially with obese patients over BMI 25. The primary~     endpoint is number of harvested lymph node that is critical point regarding quality of~     surgery in gastric cancer treatment. The secondary endpoint is intraoperative bleeding,~     surgeons' satisfaction.~      The patients were randomly assigned to two groups using a computer-generated randomization~     table : 196 persons~        -  Deep neuromuscular block group (98persons)~        -  Moderate neuromuscular group (98persons)~   "
28283|NCT03196778|"~     Older studies in animals and humans have shown cancer responses to very low doses of~     whole-body or hemi-body radiation. To study the effects of low doses of radiation in patients~     with recurrent prostate cancer, investigators will enroll up to 21 patients for 10 fractions~     of low dose radiation, delivered over 5 weeks. Participants will be followed on study for 12~     months, capturing PSA, CBC, QoL and blood samples for immunological analysis.~   "
28284|NCT03196765|"~     This is a phase I/II, open label dose escalation study of multiple dose levels of NV1205 with~     a long-term treatment phase.~   "
28285|NCT03196752|"~     The cricothyroid membrane is the most common position that the invasive airway secure is~     performed, but it is not easy to identify the cricothyroid membrane by tactile perception.~     Although it is recommended to use the laryngeal handshake method for identifying the~     cricothyroid membrane in difficult airway society 2015 guidelines for management of~     unanticipated difficult intubation in adults, there is only suggestion without clinical data~     about how much the laryngeal handshake method improves the accuracy of identification of the~     cricothyroid membrane So we made the hypothesis that the cricothyroid membrane is identified~     more correctly when the laryngeal handshake method is used than when that method is not used.~     And we try to find out whether there is actual difference about identification of the~     cricothyroid membrane between using the laryngeal handshake method and not using that method.~     By identifying the difference between them, we are going to support the recommendation of~     guidelines and make the evidence for educating the doctors who have any possibility to~     perform the criocthyroidotomy to use the laryngeal handshake method skillfully in the 'cannot~     intubate, cannot oxygenate' situation.~   "
28286|NCT03196739|"~     Because virtual reality can provide more enriched environment, repetitive goal-oriented~     tasks, and increased patients' interest and motivation, it is expected to stimulate~     neuroplasticity of injured brain and promote recovery in patients with brain disorders. On~     the other hand, immersive virtual reality using a head-mounted display has not yet been~     attempted in the rehabilitation of patients with brain disorders. In addition to the benefits~     of existing virtual reality or game rehabilitation, immersive virtual reality can further~     enhance brain plasticity, such as the effect of mirror therapy or action observation, through~     self-awareness of the body in the virtual space. The purpose of this study is to investigate~     the feasibility of applying the immersive virtual reality using a head-mounted display in~     patients with upper extremity dysfunction due to brain disorders.~   "
28287|NCT03196726|"~     Randomized-controlled trial on the effectiveness of managing postnatal depression mothers at~     primary care clinics using Cognitive-behavioural therapy treatment by nurses as adjunct to~     management by Medical Officer as compared to Medical Officer alone~   "
28288|NCT03196713|"~     The objective of this study is to examine the significance of knowledge of autism spectrum~     disorder (ASD), and early intensive behavioral intervention, as well as trust in EIBI,~     adequate assessment of EIBI quality, and EIBI supervision on EIBI intervention outcome in~     ASD.~   "
28289|NCT03196700|"~     The study wants to define the maximum tolerated dose (MTD), safety and efficacy of a short~     course radiation treatment in patients with symptomatic advanced head and neck cancer.~   "
28290|NCT03196687|"~     Patients with type 2 DM may develop a cardiomyopathy often called diabetic cardiomyopathy~     which is characterized by left ventricular diastolic dysfunction in early stages~      Type 2 DM is associated with various types of subclinical target organ damage resulting in~     elevated risk of CVD events, moreover there is growing evidence that a prediabetic status,~     such as impaired fasting glucose is also related to subclinical target organ damage when~     compared to a group with normal glucose metabolism Diabetes mellitus is a well-studied major~     risk factor for coronary heart diseases, which is one of the leading causes of death~     worldwide. Another distinct entity of diabetes-related cardiac affection is the diabetic~     cardiomyopathy. This entity of cardic affection by diabetes still needs more and more~     attention, not only because it is common in diabetic patients, but also because of its easy~     detection by the simple, inexpensive and widely available diagnostic echocardiography.~   "
28291|NCT03196674|"~     This study will compare the effect of manipulated vs. non-manipulated feedback during the~     rehabilitation of individuals with disability due to stiff shoulder following multiple~     trauma. This will be accomplished using the state-of-the-art real-time motion capture~     technology.~   "
29949|NCT03175016|"~     This is a multicentre, open labeled, single arm study to determine effectiveness and safety~     of chemoembolization with Irinotecan-Eluting Bead(DEBIRI) in the treatment of unresectable~     liver metastases in patients with colorectal cancer after chemotherapy failure.~   "
28292|NCT03196661|"~     Adopt the design of random, blind method and placebo to parallel control and progressive~     methods of groups to study and evaluate the safety and immunogenicity of influenza A (H7N9)~     vaccine (two types, one type with two specifications) on people of different ages. The~     vaccines used for testing include: influenza A (H7N9) virus inactivated vaccine/split~     influenza vaccine (15μg /dose), influenza A (H7N9) virus inactivated vaccine/split influenza~     vaccine (30μg / dose), influenza A (H7N9) virus inactivated vaccine/whole influenza vaccine~     (7.5μg / dose) and influenza A (H7N9) virus inactivated vaccine/ whole influenza vaccine~     (15μg / dose).~      The study between different subgroups was carried out in an orderly and progressive manner,~     that is, each kind of vaccine by the dose is from low to high according to the order of age~     from old to young. Firstly, the study on 15μg/dose split vaccine group (aged 18 and above)~     and 7.5μg/dose whole-virus vaccine group (aged 18 and above) was carried out and then the~     study on 15μg/dose split vaccine group (aged 12-17) and 7.5μg/dose whole-virus vaccine group~     (aged 12-17) was conducted upon 7-day safety was confirmed after the vaccination, finally the~     study on 30μg/dose split vaccine group (aged 18 and above) and 15μg/dose whole-virus vaccine~     group (aged 18 and above) was done. By that analogy for the same conditions, the next group~     of test can be done after the 7-day safety of the last group of vaccine is confirmed.~      Subjects and researchers didn't know the formulations of the vaccines used. The vaccine is~     injected into the upper arm deltoid muscle. After 30 minutes of field observation on safety,~     the subjects' axillary temperature shall be recorded on the Record Book prepared by the~     research and local and systemic reactions to injection at the 6th, 24th, 48th, and 72th hour~     and on the 4th, 8th, 21st and 30th day shall also be recorded. This paper collected 5 serum~     samples: day 0 (before the first-dose vaccination), day 4 (after the first-dose vaccination),~     day 21 (before the second-dose vaccination), day 25 (fourth day after the second-dose~     vaccination) and day 42 (21st day after the second-dose vaccination), of which, blood samples~     on day 0, 21 and 42 should be stored at 18℃ for antibody detection and the remaining 2 blood~     samples are only used for blood routine examination, routine urine test, blood biochemistry~     and other laboratory examinations.~   "
28293|NCT03196648|"~     The purpose of this study is to evaluate the safety and efficacy of a newly formulated~     foaming gel product on gingivitis and/or moderate periodontitis when used with or without the~     GLO Science accelerating device (GLO Device), compared to standard tooth brushing with~     antioxidant whitening toothpaste with or without flossing (split mouth design for control~     group).~      This is a 60-day randomized single blinded parallel group study. After 42 days, all use of~     interventional products were discontinued, and the participants returned to the clinical~     center at day 60 for final measurements. The primary outcomes assessed in this study were the~     differences in gingival index (GI) and bleeding on probing (BOP) from baseline to 42 & 60~     days. The secondary outcomes are tooth whitening, oral malodor, pocket depth and plaque~     amount.~      It is hypothesized that participants using the gingival health product with the GLO Device~     will experience greater reductions in GI & BOP measurements than the control group, as well~     as participants using the gingival health product on a toothbrush alone.~   "
28294|NCT03196622|"~     Identify the threshold which the handgrip strenght can be used as a screening test of~     sarcopenia.~      Handgrip strenght can be used in daily clinical practice to screen patients having sarcopenia~     to improve treatment and quality of life.~   "
28295|NCT03196609|"~     In order to understand how the intestinal microbiota plays a role in the effectiveness of an~     anti-cancer treatment by an immune control point inhibitor, this study aims to constitute a~     catalog of microbial genes of a patient with cancer. This catalog will help to characterize~     the intestinal microbiota of cancer patients and to be able to use this catalog as a~     reference tool for screening the microbiota of patients treated with immune control point~     inhibitors. To produce this catalog, five types of cancer were selected: non-small cell lung~     cancer, colorectal cancer, hepatocellular carcinoma, breast cancer and prostate cancer.~      The metagenomic analysis of a group of five different types of cancers introduces a lot of~     heterogeneity which is favorable to the richness of a catalog. For non-small cell lung cancer~     treated with immune control point inhibitors, two stool collections will be performed per~     patient (one stool collection before setting up an immune control point inhibitor and one~     collection after one month of being inhibited Of immune control point) to assess the impact~     of the immune control point inhibitor on the microbiota (pilot study). For this study, two~     stool collection tubes containing different preservative solutions will be used (one RNAlater~     tube and one DMSO-EDTA tube for Dimethylsulfoxide-Ethylene diamine tetraacetic acid).~      In parallel, we will also collect samples of serum and plasma to evaluate, in a second step,~     protein markers in circulating blood.~   "
28296|NCT03196596|"~     Transcatheter aortic valve implantation is increasingly used to treat patients with severe~     aortic stenosis who are at increased risk for surgical aortic valve replacement and is~     projected to be the preferred treatment modality. As patient selection and operator~     experience have improved, it is hypothesised that device-host interactions will play a more~     dominant role in outcome. This, in combination with the increasing number of valve types and~     sizes, confronts the physician with the dilemma to choose the valve that best fits the~     individual patient. This necessitates the availability of pre-procedural computer simulation~     that is based upon the integration of the patient-specific anatomy, the physical and~     (bio)mechanical properties of the valve and recipient anatomy derived from in-vitro~     experiments. Patient-specific computer simulation may improve outcome of TAVI by proposing~     the valve size that best fits the individual patient.~      The aim of this study is to assess the added value of patient-specific computer simulation in~     valve size selection.~   "
28297|NCT03196583|"~     Oral appliances (OA) have emerged as an alternative to continuous positive airway pressure~     (CPAP) for obstructive sleep apnea (OSA) treatment. The most commonly used OA reduces upper~     airway collapse by advancing the mandible (mandibular advancement devices, MAD).~      There is a strong evidence base demonstrating that MADs improve OSA in the majority of~     patients, including some with more severe disease. However, MADs are not efficacious for all,~     with approximately one-third of patients experiencing no therapeutic benefit. Patients often~     prefer MADs to gold-standard CPAP treatment. Head-to-head trials confirm CPAP is superior in~     reducing OSA parameters on polysomnography; however, this greater efficacy does not~     necessarily translate into better health outcomes in clinical practice. Comparable~     effectiveness of MADs and CPAP has been attributed to higher reported nightly use of MADs,~     suggesting that inferiority in reducing apnoeic events may be counteracted by greater~     treatment adherence.~      The MAD in study, called Bite-Velo Linguale (BVL), features a novel monobloc device including~     a tongue retainer, a suction cavity that maintains the tongue down onto the mouth floor in~     order to prevent it from raising towards the hard palate, and therefore increasing the retro~     lingual aerial space. Its design requires the presence of only four occlusal points, allowing~     for a direct anchorage onto the mandibular bone, thus reducing the risk for occlusal changes,~     tooth loosening and the development of an anterior cross bite, which represent some of the~     major long-term adverse effects of oral appliances.~      MADs are generally well tolerated, although short-term adverse effects during acclimatization~     are common. Long-term dental changes do occur, but these are for the most part subclinical~     and do not preclude continued use. The BVL in study features technological advances aimed at~     preventing long-term dental changes, as well as improving tolerability and easiness of use.~   "
28298|NCT03196570|"~     The purpose of this study is to determine the feasibility and preliminary efficacy of a web~     and text-messaged based intervention designed to increase physical activity among Latino men~     in Rhode Island. The study will also examine potential moderators of treatment effects~     including demographics, acculturation, and environmental variables such as the neighborhood~     built, social and economic environments.~   "
28299|NCT03196557|"~     The purpose of this study is to assess the pharmacodynamics of Prednisolone in healthy male~     subjects~   "
28300|NCT03196544|"~     The overall goal of this project is to develop a novel transdiagnostic behavioral treatment~     -- social approach training -- intended to enhance positive social connections in individuals~     with elevated anxiety and/or depression. Social relationship impairments are pervasive and~     debilitating consequences of anxiety and depression. Existing treatments have some beneficial~     impact on social functioning; however, many people continue to have few and/or poor quality~     relationships following treatment, even after experiencing symptom relief. This study will~     evaluate the effects of social approach training on the brain systems that have been shown to~     be important for establishing positive connections with others. Approximately 60 individuals~     (ages 18-55) seeking treatment for anxiety or depression will participate in this study.~     Participants will be randomly assigned with equal probability to one of two versions of~     social approach training (5 or 10 sessions) or a waitlist (assessment only) control group.~     Participants will be assessed at baseline and post-treatment and compared on measures~     assessing brain responses to social reward (primary outcome), as well as physiological,~     behavioral, and emotional responses to social reward (secondary outcomes). It is hypothesized~     that participants assigned to social approach training will display greater increases from~     pre- to post-treatment in activity in brain systems that regulate the processing of social~     reward (e.g., striatum) relative to participants in the control group. This study will also~     determine whether the 5- vs. 10-session versions of the treatment program result in~     meaningful differences, compared to each other, in how the brain responds to social reward.~   "
28301|NCT03196531|"~     The purpose of this study is to assess the bioequivalence of Xisimin (loratadine) compared~     with Clarityne in healthy participants receiving a single dose of 10 milligram (mg) under~     fasting condition as part of Cohort 1 and under fed condition as part of Cohort 2.~   "
28302|NCT03196518|"~     The goal of the study is to evaluate a new imaging test that may allows the investigators to~     predict the uptake of radioactive iodine by thyroid cancer faster than the current standard~     and that does not interfere with the uptake of radioactive iodine used for therapy.~   "
28303|NCT03196505|"~     This study is prospective, randomized trial in which the efficacy of liposomal bupivacaine~     (Exparel®) is compared to standard bupivacaine local surgical site injection in reducing~     total IV and oral morphine equivalents required after laparoscopic bariatric surgery.~     Liposomal bupivacaine is a 72-hour bupivacaine that is slowly released from tissue over the~     course of three days. Having a long acting local anesthetic should provide better pain~     control than conventional bupivacaine which has a 3.5-hour half-life. In some studies, the~     use of liposomal bupivacaine has been shown to decrease pain and narcotic use after surgery.~     This has not yet been studied in bariatric patients and the use of liposomal bupivacaine can~     potentially improve patient post-operative pain control, decrease narcotic use, decrease~     hospital length of stay and readmission rates and improve patient satisfaction after~     bariatric surgery.~   "
28304|NCT03196492|"~     The investigators are doing a study on the bacteria that normally live in the vagina and what~     effect, if any, Depo-Provera has on the bacteria.~      Women 13-24 years of age, who are HIV negative, being seen in a clinic for birth control or~     sexually transmitted disease (STD) check-up, or have a child and are planning to receive a~     Depo-Provera shot for contraception or have declined the use of hormonal contraception may~     join.~   "
28305|NCT03196479|"~     This study aimed to compare the efficacy of ketamine and propofol mixture with 1:6 ratio and~     1:4 ratio for endoscopic retrograde procedure~   "
28306|NCT03196466|"~     The purpose of this study is to develop population pharmacokinetic models for antiepileptic~     drugs in a pediatric population.~      The interest of these models is multiple:~        -  describe the pharmacokinetics of these molecules in children and explain the~          inter-individual variability of concentrations through covariates such as weight, age,~          co-treatments and renal function;~        -  estimate maximum, minimum and exposure concentrations from the individual~          pharmacokinetic parameters for each patient;~        -  propose adaptations of doses for certain classes of children (according to age, weight~          etc.) and individualize the doses.~   "
28307|NCT03196453|"~     Children with abnormal weight development of BMI will be given either placebo or a probiotic~     protein formula and measures of weigh gain during a 3-mont treatment will be conducted~   "
28308|NCT03196440|"~     The purpose of this study is to identify the thresholds sensitivity of the five basic tastes~     in an elderly population and relate to food intake, nutritional status, age, gender and~     others variables.~   "
28309|NCT03196427|"~     The purpose of this study is to determine the safety profile of long-term vedolizumab IV~     treatment in pediatric participants with UC or CD.~   "
28310|NCT03196414|"~     To test the safety and efficacy of giving targeting CD138 or B-cell maturation antigen T~     cells in treating patients with CD138 or BCMA positive multiple myeloma that is refractory to~     further chemotherapy or relapsed(after stem cell transplantation or intensive chemotherapy).~   "
28311|NCT03196401|"~     This study is being done to evaluate whether the combination of immune therapy and radiation~     therapy to plasmacytoma that can stimulate the immune system to attack and eliminate the~     abnormal cells in the bone marrow and perhaps delay or prevent the cancer from worsening.~     This study will evaluate whether the immune system responds to the combination of radiation~     with immunotherapy. It is possible that that the combination of immune therapy and radiation~     may not make any difference in whether or not the patient will develop multiple myeloma in~     the future.~   "
28312|NCT03196388|"~     This research study is evaluating a drug called enzalutamide in combination with external~     beam radiation therapy as a possible treatment for prostate cancer. Presently, when~     participants receive hormonal therapy with radiation therapy for prostate cancer, medications~     are given to reduce testosterone levels in the blood stream. This leads to side effects such~     as loss of sex drive, erectile dysfunction (ED) and decrease in muscle strength. The purpose~     of this study is test another form of hormonal therapy with radiationtherapy. The medication~     called enzalutamide will be used with radiation therapy. Instead of lowering testosterone,~     enzalutamide blocks testosterone in cells. This study will test if enzalutamide when used~     with radiation will lower the PSA without causing the side effects associated with~     medications that lower testosterone in the blood stream~   "
36061|NCT03094585|"~     The purpose of this study is to examine (a) nurses' knowledge about and attitude towards~     clinical research, and (b) the effect of written and oral information on nurses' knowledge~     about and attitude towards clinical research.~   "
28313|NCT03196375|"~     The COMMEND Study will assess the safety and effectiveness of FLX-787 in men and women with~     Motor Neuron Disease [including Amyotrophic Lateral Sclerosis (ALS), Primary Lateral~     Sclerosis (PLS) or Progressive Muscular Atrophy (PMA)] experiencing muscle cramps.~     Participants will be asked to take two study products during the course of the study. One of~     these study products will be a placebo.~      Approximately 120 participants in approximately 30 study centers across the United States are~     expected to take part. Participants will be in the study for approximately 3 months and visit~     the study clinic 3 times.~   "
28314|NCT03196362|"~     Short-term intensive insulin therapy (SIIT) induces glycemic remission in patients with newly~     diagnosed type 2 diabetes. But remission rate reduces over time. This study aims to~     investigate whether sequential treatments using fixed dose combination of~     pioglitazone/metformin (15mg/500mg) after SIIT can improve clinical outcomes inpatients with~     newly diagnosed type 2 diabetes.~      We plan to include 50 patients with newly diagnosed type 2 diabetes who are drug naïve and~     meet the inclusive criteria will be enrolled. After baseline assessments, SIIT will be~     applied to all patients using insulin pump to achieve and maintain euglycemia for 2 weeks.~     After completion of intensive treatment, insulin pump will be stopped. Patients were randomly~     assigned into either of the following two groups: PIO/MET group: pioglitazone/metformin~     (15mg/500mg) will be orally administrated twice daily to the subjects for 12 weeks; placebo~     group: placebo is given twice daily to all subjects for 12 weeks. Afterwards, patients will~     be followed up for 48 weeks. Primary endpoint is difference in remission rate at the end of~     study. Secondary endpoints include proportion of patients who achieve glycosylated hemoglobin~     A1C <7% at the end of study; differences in β-cell function , insulin sensitivity and~     incidence of adverse events among treatment groups.~   "
28315|NCT03196349|"~     Comparison of Oral anticoagulants (warfarin, apixaban and rivaroxaban) for extended VEnous~     Thromboembolism.~   "
28316|NCT03196336|"~     Hypothesis: Pharmacotherapy follow-up can improve clinical outcomes of outpatients with type~     2 diabetes mellitus.~      Methods: In this single blind, placebo-controlled trial, the participants with type 2~     diabetes mellitus are randomized into two groups:~        1. pharmaceutical care intervention (n=30, attended by the protocol of follow-up) and~        2. control (n=30, attended by the usual procedure of dispensing).~      Primary outcomes evaluated are: hospitalization (percentage of participants hospitalized),~     severe evolving complication - ischemic or proliferative retinopathy, severe renal~     insufficiency, severe hypoglycemia, coronaropathy or evolving foot lesion (presence or~     absence).~      Other parameter checked: A1c hemoglobin (HbA1c), blood glucose (BG), blood pressure (BP),~     total cholesterol (TC), waist circumference (WC), body mass index (BMI) and mortality. The~     investigators follow up all patients for up to 12 months.~   "
28317|NCT03196323|"~     The overall purpose of this study is to develop a broad-based (i.e., multiple domains)~     behavioral outcome measure for children between the ages of 3-18 years with Rett syndrome~     (RTT). The innovative approach of this proposal consists of integrating the process of~     developing a behavioral questionnaire to an ongoing large-scale data collection project. The~     Natural History Study of Rett Syndrome and Related Disorders (RTT5211) is a project that~     collects data on diverse aspects of the clinical evolution of individuals with RTT and~     related disorders. This project will serve as the basis for recruitment of subjects and it~     will also provide key demographic and clinical data for cohort characterization and for~     determining clinical relevance of the instrument (RettBe). An initial 100-subject cohort will~     allow for the testing with one rater of RettBe 1.0, a 50-item questionnaire formed from~     existing measures, a panel of clinicians and behavioral experts in RTT, and a focus group of~     parents and caregivers of children with RTT. Scores on RettBe 1.0 will be statistically~     analyzed to determine their psychometric properties, including its content validity. Items~     that do not meet psychometric standards (e.g., ceiling effect) will be eliminated.~      Additional items will be added if the parental survey attached to RettBe 1.0 or clinician~     input suggests so. The resulting modified assessment, called RettBe 2.0, will be administered~     to a larger (validation) cohort of 300 participants. RettBe 2.0 will also be subjected to~     analysis of psychometric properties. RettBe 2.0 will also be administered to two raters per~     subject, in order to determine inter-rater reliability. In addition, these raters will be~     completing other behavioral and clinical measures for further evaluating the validity of~     RettBe 2.0 as well as for determining its clinical and functional significance. Finally, the~     investigators will obtain input from a panel of clinicians (site PIs and their designated~     clinicians) about content validity and clinical impact. The resulting version will be~     released as RettBe 3.0.~   "
28318|NCT03196310|"~     Single blinded PRP vs. Corticosteroid vs. Placebo (normal saline) intra-articular injection~     for basal joint arthritis.~   "
28319|NCT03196297|"~     This trial is conducted in Asia, Europe and the United States of America (USA). The aim of~     the trial is to assess the efficacy of concizumab administered s.c. (subcutaneously, under~     the skin) once daily in preventing bleeding episodes in patients with severe haemophilia A~     without inhibitors.~   "
28320|NCT03196284|"~     This trial is conducted in Africa, Asia, Europe and North America. The aim of the trial is to~     assess the efficacy of concizumab administered s.c. (subcutaneously, under the skin) once~     daily in preventing bleeding episodes in haemophilia A and B patients with inhibitors.~   "
28321|NCT03196271|"~     An evaluation of the tolerance, compliance, acceptability and safety of a nutritionally~     complete liquid feed for use as part of the ketogenic diet (KD) in children 8+ years,~     adolescents and adults with intractable epilepsy or other disorders where the KD is~     indicated.~   "
28322|NCT03196258|"~     Psychological factors such as stress, distress, anxiety, depression, and poor coping~     strategies may be associated with ongoing pain following injuries such as fractures. In order~     to study this relationship, researchers at McMaster University have developed the Somatic~     Pre-Occupation and Coping (SPOC) questionnaire, which identifies illness beliefs that may~     help to predict which patients are at risk for ongoing pain, reduced quality of life, and~     delays in returning to work and leisure activities after a fracture requiring surgical~     treatment. Previous research using the SPOC questionnaire suggests the possibility that~     fracture patients with illness beliefs that put them at risk for developing ongoing pain~     could be identified early in the treatment process. These patients may benefit from cognitive~     behavioural therapy (CBT) which is designed to modify such thoughts with the goal of reducing~     ongoing pain and improving quality of life. The goal of this study is to determine if CBT is~     effective in reducing ongoing pain and improving quality of life in fracture patients who~     show illness beliefs that may place them at risk for developing ongoing pain.~   "
28323|NCT03196245|"~     Pregnant women have increased morbidity and mortality due to infection with influenza.~     Changes in T cell function have been proposed as possible mechanisms for this finding. We~     believe that pregnancy induced changes in NK cell phenotype and function also impact~     influenza immunity. This study will compare the immune response of pregnant women and~     controls to TIV influenza vaccination as a surrogate for infection. In addition pregnant~     women with flu like illness will be enrolled to evaluate changes in immune response following~     influenza infection as compared to vaccination.~   "
28324|NCT03196232|"~     This phase II trial studies how well epacadostat and pembrolizumab work in treating patients~     with gastroesophageal junction or gastric cancer that has spread to other parts of the body~     and cannot be removed by surgery. Epacadostat may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth. Monoclonal antibodies, such as pembrolizumab, may~     block tumor growth in different ways by targeting certain cells. Giving epacadostat and~     pembrolizumab may work better in treating patients with gastroesophageal junction or gastric~     cancer.~   "
28325|NCT03196219|"~     An open-label and single-blind phase 2 study to evaluate the oral microbiology, safety and~     tolerability of multiple C16G2 Varnish and Strip applications in male and female dental~     subjects 12-75 years of age. The study will compare multiple study drug administrations of~     C16G2 Varnish and/or C16G2 Strip in three study arms.~      In Study Arm 1 eight subjects will be enrolled in an open-label manner and will receive a~     daily dose of C16G2 Varnish application over 3 days followed by 14 doses of C16G2 Strip~     administered over 7 days. Following the three C16G2 Varnish applications, each subject will~     receive 7 days of AM and PM dosing with C16G2 Strip and will be followed for microbiology for~     up to 2 months after the last study drug administration.~      Study Arm 2 will enroll 12 subjects in a single-blind manner. Subjects will receive four~     C16G2 Varnish or Placebo applications over 7 days, followed by 3 additional weekly varnish~     administrations. Subjects will be followed for microbiology for up to 2 months after the last~     study drug administration.The treatment allocation will be 1:1 (6 subjects receiving C16G2~     Varnish, 6 subjects receiving Placebo).~      Study Arm 3 will be initiated based on the Sponsor's review of all microbiology data up to~     two week post last study drug administration from Study Arm 2. If initiated, Study Arm 3 will~     enroll 6 subjects in an open-label manner. Subjects will receive daily single doses of C16G2~     Varnish over 10 days, for a total of 10 doses and will be followed for microbiology for up to~     2 months after the last study drug administration.~   "
28326|NCT03196206|"~     Assess the pharmacokinetics, safety, and tolerability of a single dose of BMS-986177 in~     participants with normal renal function and moderate to severe renal impairment.~   "
28327|NCT03196193|"~     The purpose of this study is to compare reduction positon maintenance rate at 3 weeks~     post-operatively between patients operated with Anterior Support Screw (AS2) and without AS2~     technique in RCT setting. Total 240 cases(each arm 120 cases) will be enrolled at maximum~     15sites, total study duration is 22months.~   "
28328|NCT03196180|"~     This phase I clinical trial studies the side effects of topical fluorouracil and imiquimod~     ointment in treating patients with high-grade cervical intraepithelial neoplasia. Topical~     fluorouracil may kill precancerous cells. Imiquimod ointment may stimulate the immune system.~     Applying topical fluorouracil and imiquimod ointment may cause fewer side effects and may be~     a better way to treat patients with precancerous cervical lesions.~   "
28329|NCT03196167|"~     The purpose of this study is to demonstrate faster time to extubation after arrival in the~     cardiothoracic intensive care unit (ICU) in patients undergoing isolated coronary artery~     bypass grafting (CABG) who receive Sugammadex as compared to placebo.~   "
28330|NCT03196154|"~     Progression of T2DM is widely accepted to be contributed by two main components: beta cell~     function deterioration where insulin secretion is impaired and insulin resistance where~     insulin physiological response is reduced. Insulin resistance and beta cell function will be~     estimated through a mathematical model, homeostasis model assessment. Fasting insulin and~     C-peptide will be measured using liquid chromatography tandem mass spectrometry. Insulin~     resistance and beta cell function is then compared with the glycaemic control, HbA1C.~   "
28331|NCT03196141|"~     The purpose of this study is to compare 3 methods of assessing endothelial function in~     healthy female volunteers and pregnant women with and without pregnancy induced hypertension.~     The methods under comparison are simultaneous tissue oxygen saturation (StO2), EndoPAT and~     Sphygmocor (pregnant women only). 35 participants (15 healthy, 10 pregnant normal blood~     pressure, 10 pregnant with hypertension) will be enrolled.~   "
28332|NCT03196128|"~     This study will examine whether or not the use of digital communication methods (text~     messages and emails) improves patient engagement with Early Intervention Psychosis (EIP)~     Services, compared to standard communication methods (letters and telephone calls).~      One of the biggest challenges of psychiatric services is patient disengagement. People with~     psychosis, are often difficult to engage in community based mental health services (CMHTs).~     Patient's who disengage from psychiatric care often have higher social care needs, are often~     more unwell and are more likely to be detained under the Mental Health Act compared to those~     who engage. It is important to examine the reasons for this for both research and clinical~     reasons to establish the effectiveness of the service to its users. Importance must be placed~     on the clinician's perspective of the engagement; the patient's perspective is vital.~      This study is a pilot two-arm pragmatic Randomised Control Trial to examine the feasibility~     of assessing engagement of EIP services through different communication methods. Patients and~     care-coordinators will use self-reported scales to measure engagement to determine whether~     this improves through the use of different communication methods.~      Patients will be asked to consent to being randomly allocated to one of two groups:~      (i.) Receive letters, phone calls and voicemail's from their care coordinator for standard~     appointments.~      OR~      (ii.) Receive text messages and emails from their care-coordinator for standard appointments.~      Patients eligible for this study will be in their first six months of care under an EIP CMHT~     and who have consented to take part. They will be aged 18-35, not a hospital inpatient, have~     access to the Internet, a mobile phone and who are fluent in the English language.~      Care-coordinators will assess the feasibility and acceptability of the design and procedures~     and determine an effective sample size calculation for a future large scale pragmatic~     Randomised Controlled Trial.~   "
28333|NCT03196115|"~     Development of a new MS-based biomarker for the early and sensitive diagnosis of Hyaline~     fibromatosis syndrome from plasma~   "
28352|NCT03195868|"~     This study seeks to determine if photobiomodulation (PBM, or low level laser light) affects~     the growth and distribution of nerves int he skin. Our previous study demonstrated that the~     treatment we use here was effective at reducing the symptoms of neuropathy (as measured by~     the modified total neuropathy score) in patients who had been treated with chemotherapy. The~     current effort is designed to repeat this confirm this observation using a more extensive~     battery of survey as well as to begin to elucidate the mechanism through which~     photobiomodulaiton produces the effect. WE will also be attempting to determine if diabetic~     patients differ in terms of response from chemotherapy patients~   "
28358|NCT03195790|"~     Pediatric obesity interventions for low-income populations are increasingly delivered in~     children's homes, which may make treatment more accessible to families and enhance the~     potency of the intervention in several ways. This randomized trial will directly test whether~     delivering family-based behavioral interventions for pediatric overweight/obesity in the home~     setting improves weight loss outcomes in low-income children relative to medical center-based~     treatment. The trial will also quantify the cost-effectiveness of home visitation, and~     explore the mechanisms accounting for observed treatment effects~   "
28334|NCT03196102|"~     While the military has taken steps to reduce tobacco use over the past two decades, over a~     quarter of new military recruits report regular tobacco use prior to enlistment. This rate is~     higher than the national prevalence of 21.3% of US adults. Brief health prevention programs~     may be particularly effective for Airmen in Technical Training, given that all Airmen have~     been tobacco free for 11 ½ weeks and nearly 2/3rds are confident that they won't return to~     tobacco. We have developed and validated a Brief Tobacco Intervention (BTI) that is currently~     being implemented as part of Technical Training. We found that a motivational interviewing~     based, 40 minute BTI was efficacious in increasing perceived harm and decreasing intentions~     to use tobacco in a sample of 1055 Air Force trainees. Although we obtained significant~     positive changes in latent cognitive constructs for tobacco behavior that are highly~     predictive of future tobacco use in youth and young adults, the Little et al study did not~     obtain measures of actual tobacco resumption following the ban on tobacco in Air Force~     training. Given that 69.8% of all tobacco resumption/initiation occurs in Technical Training,~     a study that evaluates the short-term impact of our BTI on actual tobacco use is necessary~     prior to conducting the full scale R01 that would evaluate the long term efficacy of the BTI~     intervention. Thus, we propose the following Specific Aims: (1) To recruit approximately~     2,000 Air Force trainees at the beginning of Technical Training at Joint Base San~     Antonio-Lackland Air Force in San Antonio, Texas during the 11 ½ week involuntary cessation~     ban; (2) To randomize participants to either (a) receive our cigarette smoking military~     tailored pamphlet (HL095758), The Airmen's Guide to Remaining Tobacco Free (Airmen's Guide;~     which has been disseminated and is now the standard of care in the Air Force) or (b) the~     Airmen's Guide + Brief Tobacco Intervention (BTI); (3) To determine the short-term (3 month,~     end of Technical Training) efficacy of the intervention on tobacco abstinence. Our primary~     outcome is tobacco abstinence at the end of Technical Training to determine an estimated~     effect size as well as establish the requisite preliminary work for a subsequent R01. Given~     that over 220,000 new recruits enter the military annually in one of the service branches,~     the public health implications of an effective brief tobacco intervention targeting the most~     commonly used tobacco for military personnel in Technical Training is considerable. If the~     BTI is proven efficacious it can be easily disseminated to other service branches that have~     similar tobacco bans during Technical Training.~   "
28335|NCT03196089|"~     In a randomized, sham-controlled trial the investigators will test whether supplemental~     oxygen given during cardiopulmonary exercise testing will improve exercise performance and~     physiological parameters in patients with chronic obstructive pulmonary disease.~   "
28336|NCT03196076|"~     The purpose of this research study is to evaluate contrast-enhanced ultrasound for kidney~     malignancies.~   "
28337|NCT03196063|"~     Patellar tendinopathy is characterized by anterior pain in the knee, due to the great demand~     imposed on the extensor mechanism of the knee. Evidence shows that the most appropriate~     treatment for this condition is the conservative treatment, through strengthening with~     eccentric exercises. However, a recent editorial proposes a new treatment protocol based on~     concentric and eccentric exercises, with the initial prescription of isometric exercises. The~     hypothesis of this study is that the protocol is as good as the eccentric exercises,~     generating less pain.~   "
28338|NCT03196050|"~     Cancer is becoming a chronic disease, with the requirement of a lifelong intake of~     cancer-controlling drugs. While young(er) patients may cope with this, geriatric cancer~     patients may require a more customized and tailored follow up.~      Most elderly patients have multiple other diseases (comorbidities) and, due to many other~     factors, may per se not tolerate or simply not follow anticancer therapies. This may not only~     impair quality of life (QoL), but on the long rung also the therapeutic outcome (survival).~      Handheld devices provide a new reporting/communication tool for patients and health care~     providers. TeleGraPH will assess if these devices are a suitable communication modality in a~     cohort of geriatric cancer patients.~   "
28339|NCT03196037|"~     Purpose:To gather preliminary data and to determine the feasibility and acceptability of an~     8-week Tai Chi intervention for adults cancer survivors (survivors) who report experiencing~     cognitive impairment, and to perform exploratory analyses to assess improvements in cognitive~     performance, health-related quality of life, brain activity, and blood-based biomarkers.~      Participants: Adult survivors (> 18 years old) who report experiencing cognitive impairment~     and are within 60 months of completion of chemotherapy for treatment of a breast cancer~     diagnosis.~      Procedures (methods): A single arm pre-/post-test non-randomized study design in adult cancer~     survivors (Enrollment goal N=15; current age ≥ 18 years, treatment completed within 60~     months). Outcomes will be assessed at baseline and after the 8-week Tai Chi intervention, and~     consist of feasibility, acceptability, expectancy/credibility, health-related quality of~     life, cognitive performance, serum biomarkers, and brain activity.~   "
28340|NCT03196024|"~     The Corazón de la Familia study is a randomized controlled trial to examine the effects of a~     novel family-focused lifestyle modification intervention to reduce risk for type 2 diabetes~     and cardiovascular disease (CVD) among Hispanics/Latinos. Facilitated by community health~     workers, the family-focused intervention engages two members of a family in an educational~     program addressing lifestyle behaviors to support sustained engagement in healthy lifestyles~     among Hispanics with high risk for type 2 diabetes or CVD. In this study, we will conduct a~     randomized controlled trial using a 2-group design and compare the short-term and long-term~     impact of the family-focused active intervention to an individual-focused control condition~     on biological and behavioral type 2 diabetes and CVD risk factors. Furthermore, we will~     examine outcomes of participants in the family-focused intervention to determine how each~     family member's engagement in healthy lifestyle behaviors and level of support for the other~     family member's engagement in healthy lifestyle behaviors affects their own and their~     partner's outcomes.~   "
28353|NCT03195855|"~     Diabetes can affect the blood supply to the nerves in the legs. When this occurs a peripheral~     neuropathy can occur when the nerves carrying sensory information are affected. People with~     diabetic peripheral neuropathy have a high risk of foot ulceration and amputation which~     affects function and associated with high NHS and social care costs. People with diabetes can~     also have reduced movement at joints caused by increased stiffness in connective tissue.~     Reductions in ankle and big toe movement leads to increases in the pressure over the sole on~     the front part of the foot (the forefoot) when walking; this is a risk factor for ulceration.~      The study will to assess whether ankle and big toe joint mobilisations and home program of~     stretches in people with diabetic peripheral neuropathy improves joint range of motion and~     reduces forefoot peak pressures.~      Fifty eight people with diabetic peripheral neuropathy and a moderate risk of plantar~     ulceration will be recruited from a local podiatry clinic. They will be randomly assigned to~     an intervention (29 people) or control group (29 people). We will control for between-group~     differences in age using a minimization process. The intervention will consist of a 6 week~     program of ankle and big toe joint mobilisation by a physiotherapist and home stretches. The~     control group will consist of usual care including podiatry interventions.~      Outcome measures will be taken at baseline, post intervention and at 3 month follow up by an~     assessor who does not know the group allocation. Primary outcome will be ankle range while~     walking with secondary outcomes including big toe joint range, forefoot pressure while~     walking and balance.~      Changes over time between the groups will be compared statistically and the relationship~     between ankle range of motion and peak plantar pressure will be analysed using linear~     regression.~   "
28354|NCT03195842|"~     In this pilot study, limited English proficient (LEP) parents of children at Seattle~     Children's Hospital for day surgery will be randomized to usual discharge care or usual~     discharge plus language-concordant, audio-recorded instructions via recordable card. these~     cards are similar to recordable greeting cards, and can record up to 180 seconds of~     information. They can be played back over 100 times. We will follow-up with families 2-7 days~     later to assess satisfaction and comprehension of discharge instructions.~   "
28341|NCT03196011|"~     As many as 20% of patients are unhappy with the results of total knee replacement (TKR).~     Various changes to surgical technique have tried to address this but have not led to a~     significant improvement in the numbers of patients satisfied with their operation.~      Recently, attention has focussed on alignment of the leg. When viewed from the front, a~     number of people do not start with a straight, mechanically aligned leg. Traditionally, when~     implanting a knee replacement, the surgeon tries to put the shin bone half of the knee~     replacement perpendicular to the floor to equalise stresses on the in and outside of the~     joint. However, this may result in the alignment of the leg changing considerably, straining~     the soft tissues around the knee and contributing to dissatisfaction with TKR.~      There has been a move by some surgeons to change practice, and to implant the TKR in a way~     that replicates the alignment of the patient's own original knee- alternative alignment.~     Studies looking at alternative alignment have not shown any loss of satisfaction with results~     of TKR and indeed are showing some signs that in the short term, function of the knee may be~     better with the new technique.~      The research team are planning to run a study comparing the knee replacement used in Exeter-~     the Triathlon- when put in place using traditional alignment versus using the alternative~     alignment methods. The outcomes will be assessed in various ways including patient~     satisfaction questionnaires, measuring muscle strength, flexibility around the knee, and by~     assessments of alignment of the new knee on X-rays and Computerised Tomography scans. The~     research team will look at short term results for satisfaction and function of the knee, and~     in the long term look at wear and survivorship to see if patient satisfaction with TKR can be~     improved.~   "
28342|NCT03195998|"~     The most common and widely accepted method of monitoring bilirubin levels in neonates is the~     use of the laboratory analyzation of serum blood levels. Unfortunately this method is~     invasive, painful, and can progressively lead to increased blood loss in the neonate. It also~     requires the use of additional time and resources to coordinate sending the sample to the~     laboratory and processing the specimen in the lab. There exists a different option for~     obtaining bilirubin levels in neonates which is the transcutaneous bilirubinometer. This~     device detects bilirubin levels at the bedside and has been validated for use in infants born~     at > 35 weeks gestation. There are a limited number of studies evaluating its use in~     premature infants.~      Our aim is to assess the diagnostic accuracy and efficacy of transcutaneous bilirubinometry~     (TcB) of the Dräger JM-103 by comparing (TcB) readings to total serum bilirubin (TSB) results~     in neonates born at 23 0/7-34 6/7 weeks gestation.~   "
28343|NCT03195985|"~     The study will focus on measuring stress, rumination and cognitive function across three time~     points in old adults with subjective cognitive complaints via a 4-week short mindfulness~     intervention, as compare to an active control condition (psycho-education course ge Well).~      This is a pilot study.~   "
28344|NCT03195972|"~     Oral anticancer treatments are increasingly numerous. They represent an additional~     alternative in the therapeutic arsenal of the clinician, and appear to satisfy patients who~     prefer this route of administration over intravenous treatment. The objective of oral~     therapies is twofold: to remove the constraints and risks associated with infusions and to~     allow the patient to follow his treatment at home.~      However, they have significant adverse effects that may affect patients, who are sometimes at~     a disadvantage compared to how they are treated, and potentially lead to non-compliance with~     the consequences.~      This study will identify the factors associated with non-adherence and determine the impact~     of this non-adherence in terms of treatment efficacy and tolerance.~      The aim of this routine care study is to evaluate the adherence to oral anticancer therapies~     during 3 months.~   "
28345|NCT03195959|"~     Pulmonary Hypertension (PH) is a severe disease with a bad prognosis. However, thanks to~     extensive research in this field, there are more and better treatment options that allow~     patients to participate in recreational activities at moderate altitude or bring up the~     question of air-travel.~      Still very few is known about the effects hypoxic conditions have on PH patients. The aim of~     this study is to investigate the effects of hypoxia in comparison to normoxia and hyperoxia~     on pulmonary hemodynamics in patients with pulmonary hypertension during routine right heart~     catheterisation. We aim to get insight into the pathophysiology of pulmonary hemodynamics~     under hypoxic conditions in comparison to normoxia and hyperoxia in patients with pulmonary~     arterial and chronic thromboembolic pulmonary hypertension compared with control patients,~     that are scheduled for right heart catheterisation due to dyspnea but have no PH.~   "
28346|NCT03195946|"~     This study will help determine which types of drugs that may interact with Lu AF35700~   "
28347|NCT03195933|"~     The stress-related hormone cortisol has been studied in depression for decades. However,~     relatively little is known about the role of cortisol in psychological features of~     depression. Basic research shows that cortisol modulates brain processes that are highly~     relevant to depression (especially the neural substrates of negative biases in learning and~     memory formation). However, very few studies have directly examined the effects of cortisol~     on neural circuitry of learning in depressed humans. In addition, the effects of cortisol on~     the neural substrates of learning differ for males and females. The toll of depression is~     especially high in women, who are roughly twice as likely as men to suffer from depression.~     Thus, the primary goal of this project is to investigate the effects of cortisol on the~     neural circuitry of learning in depressed women.~      A secondary goal is to investigate whether early life adversity moderates cortisol's effects~     on the neural circuitry of learning. Animal data suggests that early life adversity causes~     life-long biases toward learning in threatening conditions associated with elevated cortisol.~     In addition, new data from humans suggests that alterations in cortisol traditionally~     ascribed to depression may stem in part from early adversity rather than depression per se.~     Thus, this study will examine effects of cortisol on the neural circuitry of learning in~     depressed and healthy women with and without history of early life adversity.~      The study will use pharmacological manipulation of cortisol levels (compared to placebo)~     during measurement of brain activity at rest and during memory encoding of emotional and~     neutral stimuli. The study will also measure whether cortisol alters the negative biases in~     emotional memory often seen in depression. In doing so, the study will examine the role of~     cortisol in neural networks associated with emotional learning that are often implicated in~     depression.~      Medications that target cortisol receptors in the brain may be beneficial in the treatment of~     depression. However, this knowledge has yet to inform clinical practice, and mechanisms of~     action of these medications are not well understood. This project is significant because it~     provides the prerequisite knowledge (and develops a paradigm) that can be used in the future~     in the development of more effective targeted intervention strategies.~   "
28348|NCT03195920|"~     This is a single arm, single center study to assess the safety and efficacy of a form of~     extracorporeal lithotripsy, called the Enhanced Lithotripsy System, to treat urinary stones.~   "
28349|NCT03195907|"~     This study evaluates the predictors of intensive care unit admission and mortality among~     stroke patients and the effects of pulmonary physiotherapy on these stroke patients.~     One-hundred patients participated in the pulmonary rehabilitation program and 81 patients~     served as a control group.~   "
28350|NCT03195894|"~     The primary objective is to investigate differences in the alcohol consumption pattern~     between alcohol addicts receiving conventional treatment and those who receive a combination~     of conventional treatment and TripleA.~   "
28359|NCT03195777|"~     The goal of this study is to develop strategies that will improve outcomes for patients with~     deep vein thrombosis (DVT), using in vivo FDG-PET inflammation imaging to better predict the~     development of the post-thrombotic syndrome (PTS). New approaches are needed to improve the~     outcomes of patients with DVT, a disease that affects up to 600,000 patients per year in the~     US alone. DVT acutely places patients at risk of death from pulmonary embolism and causes~     50,000 deaths annually in the US. Moreover, up to 30-50% of patients will develop PTS, an~     illness characterized by inflammation-driven fibrotic vein wall injury, and persistent~     thrombus obstruction. PTS occurs despite anticoagulant therapy, and produces chronic~     disability from leg pain, heaviness, edema, skin pigmentation, and ulcers; some patients may~     even require amputation. PTS impairs quality of life to the same extent as chronic~     obstructive pulmonary disease or diabetes. Therefore new diagnostic insights into PTS are~     urgently needed.~      There are several major challenges to improve outcomes in PTS: A) Limited in vivo knowledge~     regarding inflammation and the development of PTS; B) L Lack of predictive approaches to~     identify patients at high risk for PTS that will preferentially benefit from novel therapies.~     Recently, our laboratories have harnessed FDG-PET molecular imaging to illuminate DVT~     inflammation in vivo, and to provide a new strategy to diagnose recurrent DVT, a vexing~     clinical problem (Hara et al. Circulation 2014). We now propose to further develop FDG-PET to~     improve outcomes in DVT and PTS.~      The objective of this application is to develop FDG-PET as an inflammation imaging approach~     to assess DVT inflammation and predict risk of developing PTS in human subjects;~      Hypothesis 1A: Inflammatory activity in DVT (quantified acutely, using FDG-PET imaging within~     0-7 days after DVT) will predict PTS incidence (primary) and severity (secondary) within a 24~     month follow-up period.~      Hypothesis 1B: Inflammatory activity in DVTs (quantified sub-acutely, using FDG-PET imaging~     within 21-28 days after DVT), will predict PTS incidence and severity.~      Eighty patients with DVT will be imaged using FDG-PET/CT acutely (0-7 days of DVT diagnosis),~     and sub-acutely (21-28 days after diagnosis). Subjects will be evaluated repeatedly for up to~     2 years to detect clinical evidence of PTS (Villalta score), ultrasound findings for~     structural venous injury, and soluble biomarkers of systemic inflammation. Subsequently, we~     will evaluate the relationship between FDG DVT activity and the development of PTS.~   "
28360|NCT03195764|"~     T-1101 (Tosylate) is a new small molecule chemical entity being developed as a potential~     anti-cancer therapeutic by Taivex Therapeutics Corp. T-1101 (Tosylate) is a potent~     anti-cancer agent in numerous human cancer cell lines. In addition, oral administration of~     T-1101 (Tosylate) showed tumor growth inhibition in different mouse xenograft models of human~     cancers. In this study, safety, tolerability and PK of T-1101 (Tosylate) will be evaluated~     and also the recommended dose and regimen(s) to initiate Phase 2 will be determined.~   "
28361|NCT03195751|"~     The scope of the research is to determine if a motion-based software development kit may~     substitute for a manual goniometer. If so, this opens up the possibility of remote~     telemonitoring of upper extremities patients.~   "
28362|NCT03195738|"~     The purpose of this study is to evaluate the feasibility and effects of a cognitive~     intervention for youth following concussion~   "
28363|NCT03195725|"~     To investigate how discussions surrounding Do Not Attempt Cardiopulmonary Resuscitation~     (DNACPR) decisions have changed following the Tracey judgement and how harm is being~     defined by clinicians working within specialist palliative care in a hospice setting.~   "
28364|NCT03195712|"~     The study team's research fills the gap in the obesity literature where BMI with a cut point~     of 35 is frequently used to show the association between BMI and metabolic syndrome~     biomarkers. The study team was unable to locate any papers that showed the association~     between metabolic syndrome biomarkers and BMI from 35 to 69.9, and especially graphically as~     this clinical team has presented.~   "
28365|NCT03195699|"~     Many patients have cancers that have increased activity of a protein called STAT3 that~     contributes critically to the development and growth of their cancer. Despite our knowledge~     of STAT3's importance to cancer, scientists and doctors have not developed a drug that~     targets it and that patients can take to treat their cancer more effectively than treatments~     that are now available. StemMed, Ltd. has developed a compound, C188-9, which can be given by~     mouth and acts as a direct inhibitor of STAT3. Administration of C188-9 to mice demonstrated~     that it blocked growth of cancers of the breast, head and neck, lung, and liver and it was~     safe when administered at high doses to mice, rats, and dogs. In this application, StemMed is~     proposing to further develop C188-9 for treatment of solid tumors for which the prognosis is~     dismal. The investigators will determine how safe it is when administered to patients with~     cancer, determine whether an adequate dose can be administered to patients with cancer that~     will block STAT3 in their cancer, and determine whether treatment with C188-9 leads to~     reduced growth of their cancer.~   "
28366|NCT03195686|"~     Evaluation of efficacy of PLEM100(Inbody®) in measuring the sedation level in pediatric~     patients~   "
28367|NCT03195673|"~     The purpose of this study is to assess the safety and efficacy of low dosage of Terazosin in~     Carotid Artery Stenting~   "
28368|NCT03195660|"~     This study is designed to demonstrate feasibility of study conduct and that acceptable~     adherence to adaptive servo-ventilation (ASV) therapy can be achieved in recently~     hospitalized HFpEF patients with moderate to severe sleep apnea. All subjects meeting the~     criteria will receive ASV therapy.~   "
28369|NCT03195647|"~     The primary purpose of this pilot study will be feasibility of recruitment. However, in order~     to further inform a full randomised controlled trial (RCT), information on the incidence of~     atrial fibrillation (AF) and other arrhythmias, hospital length of stay, resource use and~     morbidity will be collected.~   "
28370|NCT03195634|"~     Portal hypertension is a common complication of chronic liver diseases and is responsible for~     most clinical consequences of cirrhosis. measurement of the hepatic venous pressure~     gradient(HVPG) is the gold standard for evaluating the presence and severity of portal~     hypertension, this technique is considered invasive and is not routinely performed in all~     centers. Wisteria floribunda agglutinin-positive human Mac-2 binding protein (WFA+-M2BP) is a~     secreted N-glycoprotein, which has been reported as a novel marker in assessing liver~     fibrosis.However, the correlation of WFA+-M2BP with HVPG is unclear.The aim of this study was~     to explore the relationship between WFA+-M2BP and HVPG.~   "
28371|NCT03195621|"~     Identifying the critical lesion of coronary artery disease and determining the interventional~     plan are significant for reducing adverse cardiovascular adverse events. The assessment of~     critical lesion requires the consideration of plaque morphology, tissue composition, and~     endometrial stress which leading to rupture. In summary, accurate assessment of critical~     lesions has high application value. In this study, patients with critical coronary artery~     disease were divided into two groups: an accurate assessment group and a simple assessment~     group, with the aim to compare the diagnosis and treatment efficiency as well as prognosis,~     potential cardiovascular risk, possible excessive intervention.~   "
28608|NCT03192540|"~     This study explores the effects of an eight-week center-based exercise intervention for~     adolescents with Down syndrome on home exercise compliance. As well, to observe changes in~     fitness including muscular strength, endurance and aerobic capacity. Finally to observe any~     changes in mood, behavior and quality of life.~   "
28372|NCT03195608|"~     Parkinson's disease (PD) impacts an individual's fitness to drive in a number of ways that~     increase the crash risk in this population. Current vehicle automation technologies are~     available, that although designed for the general public, may help drivers with PD stay on~     the roads longer and safer than currently possible. Using a driving simulator (a safe and~     cost-effective alternative with no impact on licensing for participants), this study will~     investigate the feasibility and preliminary efficacy of utilizing in-vehicle technology~     (i.e., a simulated lane change assistance system) to address critical driving errors in~     individuals with mild to moderate Parkinson's disease.~   "
28373|NCT03195595|"~     This is retrospective study that will be done in Cardiothoracic surgery department in Assuit~     university hospitals for one year duration aiming to compare minimal invasive technique to~     conventional median sternotomy for mitral valve surgery regarding early postoperative~     outcomes and pain~   "
28374|NCT03195582|"~     The aim of this study is to evaluate the healing of peri-implat tissue following surgical~     uncovering with the adjunctive use of Chlorohexidine (CHX) gel.~   "
28375|NCT03195569|"~     To reveal changes of peripheral markers and blood perfusion parameters in vivo tumor in the~     study of QL1101 and Avastin® in patients with Non-squamous Non-small Cell Lung Cancer~   "
28376|NCT03195556|"~     Our laboratory has discovered that ultrasound (US) imaging together with clinically approved~     microbubble ultrasound contrast agents can augment limb tissue perfusion. These observations~     have been made in mice with and without peripheral artery disease (PAD), and also in humans~     where high power contrast enhanced ultrasound (CEU) was used to measure perfusion but was~     found also to augment perfusion by almost 2-fold. The latter human studies were performed~     with ultrasound protocols designed for perfusion imaging and not for flow augmentation. In~     this study, we will measure the degree to which limb perfusion is augmented with specific~     therapeutic CEU settings that are still within the FDA-approved limits with regards to US~     power and contrast dosing.~   "
28377|NCT03195543|"~     The objective of the present study is to assess blood coagulation disorders in patients with~     Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension. The~     investigators aim to evaluate any possible coagulation abnormalities related to the patients'~     primary disease and any possible effects the pulmonary hypertension- specific therapy may~     have on hemostasis.~   "
28378|NCT03195530|"~     A correlation between the bispectral index values and electroencephalographic patterns at the~     loss of consciousness (LOC) when using propofol in elderly patients, has not been determined.~      Our aim is to describe the BIS values and the power of the alpha band in the~     electroencephalography in elderly patients, at the LOC moment.~   "
28379|NCT03195517|"~     The aim of our research was to define both in vivo and in vitro whether and to what extent an~     high-impact exercise program would affect bone cell turnover and improve the QoL in~     osteopenic postmenopausal women.~   "
28380|NCT03195504|"~     Before going off to sleep patients are given oxygen to saturate blood with oxygen to extend~     time before a decrease in the level of oxygen in the blood occurs. During this period, obese~     patients have a faster decrease in the level of oxygen in their blood. This study uses a~     device called high-flow nasal cannula (HFNC), which delivers humidified high-flow oxygen~     through 2 small plastic tubes placed just inside nostrils. In the intensive care unit~     settings this device has been used extensively and has become a standard practice. Purpose of~     this study is to determine whether these high-flow nasal cannula increase the time safely~     when going to sleep during elective surgery.~   "
28381|NCT03195491|"~     The purpose of this study is to investigate the safety of patients in Asia with Non-Small~     Cell Lung Cancer (NSCLC)who are treated with Nivolumab monotherapy as a second line or third~     line treatment.~   "
28382|NCT03195478|"~     A Study to Evaluate Safety and Effectiveness of Nivolumab in Combination With Ipilimumab in~     Chinese Patients With Previously Treated Late-Stage Cancer~   "
28383|NCT03195465|"~     The purpose of this study is to determine if routine consumption of high antioxidant cacao~     can have an effect on the behaviors of children with Autism Spectrum Disorder. This is~     proposed as children with Autism Spectrum Disorder have elevated oxidative stress markers,~     such as, free radicals making them highly vulnerable to oxidative damage. Thus, it is~     proposed that foods high in antioxidant activity can offer protection against oxidative~     stress and thus impact behaviors.~   "
28384|NCT03195452|"~     Raltegravir (RAL) is a very effective antiretroviral drug with a favorable long term~     tolerability. RAL offers many advantages such as lack of drug-drug interactions, a good~     safety profile particularly on lipids, inflammation and bone parameters. Ral can be an very~     interesting for patient with comorbidities and comedications, intolerance or toxicities with~     their current ARV treatment. However its current formulation of one tablet of 400mg twice a~     day coul not suit many patients.~      A new once-a-day formulation of RAL has been developed, with two tablets of 600 mg QD.~     Pharmacokinetic study in healthy volunteers has shown that this dosing provides increased RAL~     exposure compared to the standard formulation of 400 mg given twice a day.~      The objective of this study is to evaluate the maintain of virologic suppression with~     raltegravir 600mg 2 tablets qd as part of a triple antiretroviral regimen in virologically~     controlled patients.~   "
28385|NCT03195439|"~     The study has 2 phases:~        -  The Retrospective Phase (50 patients were diagnosed to have sepsis according to our~          definition and criteria and 30 patients as a controlled cases )~        -  The Prospective Phase (600 patients who will be admitted and monitored in ICU in order~          to get at least 30 sepsis cases, according to our definition and criteria).~      Measurements will be made from the forehead using the TTP's biocompatible sensor Unit that~     will be attached to the skin. The SU will transfer data to the MCU.~   "
28386|NCT03195426|"~     This study aims at assessing the effectiveness of combined suprascapular nerve block (SSNB),~     infraclavicular brachial plexus block (ICB) and supraclavicular nerve block (SCNB) as~     surgical anesthesia for patients scheduled for arthroscopic shoulder surgery. The secondary~     objective is to test the hypothesis that SSNB-ICB-SCNB combination could spare the phrenic~     nerve.~   "
28634|NCT03192202|"~     The investigators plan to investigate AFM13 and evaluate its ability to facilitate and~     redirect the Natural Killer (NK) cells in eliminating CD30-positive lymphoma targets in the~     skin and, by inference, other organs involved by the lymphoma.~   "
28387|NCT03195413|"~     This study aims to determine whether early initiation of temporary nerve block therapy~     improves patient satisfaction, decreases patient pain and discomfort, decreases the use of~     dangerous medications such as narcotics, and frees hospital resources. Hand injuries, such as~     blast injuries from fireworks, can be very painful. In the emergency department, providers~     generally use narcotic pain medications to control pain, but these have significant side~     effects. It is possible that temporary nerve blocks, guided by ultrasound, can be safe and~     useful in the emergency department. They have been shown to be effective in several studies~     around the country. The goal of this study is to build on the experience of others to~     increase the use of US-guided regional nerve blocks as a form of pain management in hand and~     distal forearm injuries in the Harborview Medical Center (HMC) emergency department. By~     working with a multidisciplinary team, the study investigators hope to use this technique to~     decrease narcotic use and improve pain control, and to provide important data for Emergency~     Medicine physicians elsewhere who are considering incorporating this nerve block technique~     into their practice.~   "
28388|NCT03195400|"~     Type 2 Diabetes (T2D) in obese youth is often preceded by a prediabetic state called:~     Impaired Glucose Tolerance (IGT), which is associated with a pre-existing defect in insulin~     secretion. This study intends to determine if genetic factors are associated with defects in~     insulin secretion, the incretin system and hepatic insulin resistance in obese adolescents.~     The long-term goal of this study is to generate information on both the genetics as well as~     the pathophysiology of Type 2 Diabetes in Youth, which ultimately might guide the~     investigators towards better preventive and treatment avenues.~   "
28389|NCT03195387|"~     This study follows a First-In-Human dose-escalation study of MMV390048 (5 to 120 mg MMV390048~     powder-in-bottle formulation), a formulation bioavailability study to establish suitable~     tablet formulation, and a two-part dose-escalation (40 to 120 mg of MMV390048) / induced~     blood stage malaria (ISBM) challenge study with the new tablet formulation. After~     identification of the predicted efficacious MMV390048 plasma concentrations in the IBSM~     model, the current study will evaluate the chemoprotective efficacy of MMV390048 in a~     standardised and validated controlled human malaria infection (CHMI) model using direct~     venous inoculation (DVI) of aseptic, purified, cryopreserved, vialed P. falciparum~     sporozoites (PfSPZ Challenge).~      Three sequential cohorts of healthy men and women of non-childbearing potential (WONCBP) will~     be administered the investigational medicinal product (IMP, i.e. MMV390048) under different~     conditions. This may identify preventative regimens, to be further investigated in a Phase II~     program. In the first two cohorts, protective administration of the IMP will occur 1 and 7~     days before DVI of PfSPZ challenge. The timing of IMP administration and dosage in the last~     cohort will be determined on the basis of emerging data from the preceding cohorts, but will~     not exceed 28 days prior to the challenge nor 120 mg MMV390048.~   "
28390|NCT03195374|"~     Chronic pain is a worldwide health problem due to its high prevalence and its difficult~     management with a significant impact on quality of life. Pain and addiction co-occur~     frequently. Indeed, the prevalence of addiction in patients with chronic non-cancer pain may~     affect from 0% to 50% of patients (Højsted et al 2010). This large variability in the~     estimation of addiction prevalence in chronic non-cancer pain patients is at least partly due~     to a lack of standardization of the selected patients from the clinical or therapeutic point~     of view and the lack of consensus in the use of a specific evaluation tool or gold standard.~     Indeed, several tools are currently available at the international level with varying~     efficiencies and precisions (Chou et al 2009, Turk, Swanson, and Gatchel 2008, Højsted and~     Sjøgren 2007). In France, no data are available on the prevalence of analgesic opioid misuse~     in chronic non-cancer pain patients, due to the lack clinical studies and validated tools in~     French.~   "
28391|NCT03195361|"~     A prospective, single arm, multi-center clinical study to evaluate the safety and performance~     of the SRS (Lyra Medical) vaginal mesh in POP patients~   "
28392|NCT03195348|"~     This study is a collaboration between the Centre of Human & Aerospace Physiological Sciences~     (CHAPS) and the Sleep and Brain Plasticity Centre (Department of Neuroimaging) at King's~     College London and the Sleep Disorders Centre at Guy's Hospital.The main purpose of the study~     is to evaluate the effects of a 7 day unloading period (simulating micro gravity) on muscle~     mass using three independent methods; two scanning techniques (magnetic resonance imaging~     (MRI) and dual x-ray absorptiometry (DXA)) and one that involves swallowing a capsule that~     contains a harmless chemical called creatine (D3-Creatine (D3-cr)) and then measuring its~     concentration in urine. In order to induce muscle loss, participants will be required to lie~     flat on their back on a water bed filled with water and salt (called hyper-buoyancy flotation~     (HBF)). As this situation is similar to that experienced in space, the investigators will~     also measure the effect of HBF on sleep, brain and physiological function - all things known~     to change in astronauts. Sixteen male subjects (18-40 yrs) will be recruited to participate~     in the study that will require physiological testing before, during and following both 7 days~     of normal conditions and 7 days of HBF bed-rest. Each subject will be exposed to the same~     conditions and assessments over the study period. As some loss of muscle is expected,~     participants will be offered an exercise rehabilitation programme upon completion of HBF with~     self-monitored and/or guided sessions based on those provided by the Space Medicine Office of~     the European Space Agency to returning astronauts.~   "
28393|NCT03195335|"~     Cerebral Palsy (CP) is the most common cause of physical disability in children, is a~     non-progressive neurological impairment resulting from an injury in the developing brain and~     causing various problems related to sensory, perception, cognition, and movement. This~     problems leads activity and participation levels of the children with CP. In the literature~     various assessment tools developed for assessing participation. Assessment of Life Habits~     (LIFE-H) questionnaire is one of the assessment tools that examines activities of daily life~     and participation in detail. The scale is originally in French but English and German~     versions are also available. The aim of this study is to translate the scale to Turkish and~     to determine validity and reliability of Turkish version of Life Habits questionnaire.~   "
28635|NCT03192189|"~     Acute kidney injury is a frequent and growing complication associated with a risk of~     progressing into a chronic kidney disease. Recent guidelines have recommended systematic~     consultations with a nephrologist 3-6 months following hospitalization. Risk factors of~     developing chronic kidney disease between hospital visits are understudied.~   "
28394|NCT03195322|"~     Primary Objective:~      • To describe postoperative static pain scores on the Pain Visual Analog Scale at Day 1 in a~     population of women undergoing bilateral mastectomy followed by immediate, bilateral~     pre-pectoral tissue expander breast reconstruction reinforced with AlloDerm® coverage.~      Secondary Objectives:~        -  To describe postoperative static and dynamic pain scores on the Pain Visual Analog Scale~          and Brief Pain Inventory—Short Form at Day 1-60 after tissue expander placement~        -  To describe nausea/vomiting, and opioid use at Day 1, 2, 3, 7, 30, and 60 after~          mastectomy and tissue expander placement.~        -  To describe short-term changes in Quality of Life scores after mastectomy and tissue~          expander placement.~        -  To describe postoperative complication rates at Day 1, 2, 3, 7, 30, and 60 after~          mastectomy and tissue expander placement.~        -  To describe nausea/vomiting, and opioid use at Day 1, 2, 3, 7, 30, and 60 after final~          reconstruction with tissue expander exchange for permanent implant.~        -  To describe short-term changes in Quality of Life scores after final reconstruction with~          tissue expander exchange for permanent implant.~        -  To describe postoperative complication rates at Day 1, 2, 3, 7, 30, and 60 after final~          reconstruction with tissue expander exchange for permanent implant.~        -  To describe postoperative rates of breast animation deformity at Day 7, 30, and 60 after~          final reconstruction with tissue expander exchange for permanent implant.~        -  To describe average hospital length of stay in patients after final reconstruction with~          tissue expander exchange for permanent implant.~        -  To describe the patient's final assessment of pre-pectoral reconstruction from free-form~          text.~      Tertiary Objectives:~      • To measure cosmetic result and associated residual pain with Alloderm® reinforcement of~     breast pocket.~   "
28395|NCT03195309|"~     To compare the postoperative analgesic effect and the intensity of motor block in different~     concentration ropivacaine plus fentanyl when used epidurally with a patient-controlled~     analgesia device after Cesarean delivery.~   "
28396|NCT03195296|"~     Graves orbitopathy (GO) is an inflammatory eye disease associated in 95% of patients with~     Graves' hyperthyroidism (GH), in ~3-4% with hypothyroid autoimmune thyroiditis, and in ~1-2%~     with thyroid autoimmunity in the absence of thyroid dysfunction, the former known as~     euthyroid GO. The pathogenesis of GO is autoimmune, with the TSH-receptor being considered~     the major autoantigen, thereby establishing a pathogenetic link between the thyroid and~     orbital tissue. Thus, TSH-receptor is expressed by orbital fibroblasts, where it forms a~     complex with the IGF-1 receptor. Unlike GH, which is notoriously caused by TSH-receptor~     stimulating autoantibodies, GO is believed to reflect cell-mediated autoimmunity, as~     suggested by studies showing a Th1-like pattern of cytokine release by primary cultures of~     orbital infiltrating lymphocytes from GO patients. On the other hand, a role of B lymphocytes~     has emerged in recent years based on the observation that the anti-CD20 monoclonal antibody~     rituximab has a beneficial effect on GO activity, as demonstrated by a recent randomized~     clinical trial in which rituximab was compared with intravenous glucocorticoids (GC), being~     the former the standard treatment of moderately-severe GO. The explanation for the findings~     was that B lymphocytes are involved in the pathogenesis of GO as antigen-presenting cells.~     However, in spite of the above mentioned promising observations, another randomized clinical~     trial in which rituximab was compared with placebo provided opposite results. Thus, rituximab~     had no effect at all on GO. Data from the two studies were confronted and major differences~     between the two cohorts emerged, especially concerning GO activity, leading to the conclusion~     that rituximab may be effective for active, but not for inactive GO. Rituximab has been~     employed also for autoimmune diseases other than GO, including type 1 diabetes. In the~     former, it was shown that the effectiveness of rituximab paralleled the presence of~     CD20-positive infiltrating lymphocytes in pancreas islets. We therefore postulated that~     something similar may occur in GO, because of which we planned the present, perspective,~     observational study, aimed at determining the presence and immunohistochemical features of~     lymphocytes infiltrating orbital tissues in patients with GO and to relate them with the~     clinical features of GO.~   "
28397|NCT03195283|"~     This study aims to investigate whether a novel meal service FoodforCare (FfC), comprising~     6-protein-rich meals a day following proactive advice from a nutritional assistant, improves~     dietary intake and patient satisfaction, compared to the traditional 3-meals a day service~     (TMS).~   "
28398|NCT03195270|"~     The investigators are studying the ability of PET/MR imaging (using the PET tracer [18F]FDG)~     to objectively identify and characterize pain generators in patients suffering from chronic~     pain.~   "
28399|NCT03195257|"~     Investigate GIP effects on biomarkers involved in bone homeostasis~   "
28400|NCT03195244|"~     To compare the efficacy of one-on-one versus group-based aquatic therapy on the social~     interactions, behaviors and physical activities of children with autism spectrum disorders~     (ASDs).~   "
28401|NCT03195231|"~     Depression is one of the most important nonmotor features of idiopathic PD（Parkinson's~     disease ）which may not just interfere with the motor symptoms of PD but can also cause~     immense personal suffering as well as decreased quality of life with increased disability and~     caregiver burden. However,there is little hard evidence to guide clinical treatment. Although~     some newer dopamine agonists also have antidepressive effect, the use of tricyclic or~     nontricyclic antidepressants is frequently required.However, the side-effects of these agents~     may also worsen some preexisting nonmotor problems in PD. Wuling powder is a Chinese medicine~     which is made by cultivating Xylariasp mycelium using submerged fermentation technology.~     Xylariasp is the fungus sclerotia which grow in termite nests. Wuling powder is mainly used~     to soothe nerves and anti-insomnia in clinical. The antidepressant effect of Wuling powder~     has been confirmed in clinical, but not in the patients of Parkinson`s disease. Therefore,~     the investigators design a randomized, double-blind, placebo-controlled study to evaluate the~     antidepressant effect of Wuling powder in PD patients and its underlying mechanism.~   "
28402|NCT03195218|"~     STUDY PURPOSES: This study aims to evaluate a high resolution microendoscope (HRME): 1) To~     assess the sensitivity and specificity of the HRME device in the detection of cervical~     intraepithelial neoplasia grade 2 (CIN2) or histologically more severe lesion (NIC2+) and~     cervical intraepithelial neoplasia grade 3 (CIN3) or histologically more severe lesion~     (NIC3+) in a comprehensive case-by-case basis; 2) Compare the accuracy of the HRME device~     with acetic acid visualization (VIA) and colposcopy. METHODOLOGY: 1,780 women with abnormal~     Pap Smears (ASCUS+) or positive high-risk human papillomavirus (HPV) test in the cervix~     performed in the Barretos Cancer Hospital (HCB, Barretos, Brazil) screening program will be~     recruited, either at Mobile Prevention Units or Fixed Units, who have been referred for~     diagnostic investigation with colposcopy. The invitation for women to participate in the~     study will be made immediately before the medical consultation for colposcopy, in the~     Prevention Department of Barretos Cancer Hospital. Women who decide to participate in this~     study will sign an Informed Consent Form after invitation and relevant explanations, which~     will be provided by the researcher in charge or by a representative with previous training~     appointed by him for the application of the Form in question. During the colposcopy~     examination, the HRME device will be used to check the presence of precursor lesions in the~     cervix. HRME will capture images from all areas considered abnormal by VIA and/or colposcopy.~     Any abnormal areas detected by VIA and/or colposcopy will undergo a biopsy. If no abnormal~     area is observed, a cervical microbiopsy will be obtained from an apparently normal area~     examined using HRME. If during the study a precursor disease or cervical cancer is detected~     in any woman, an appropriate treatment will be offered by Barretos Cancer Hospital according~     to an institutional protocol.~   "
28403|NCT03195205|"~     Approximately 3.5 - 5 million Americans are living with hepatitis C virus (HCV) in the United~     States. HCV significantly impacts rural Pennsylvania. It is estimated that 160,000 adults in~     Pennsylvania are living with hepatitis C. In 2010, Center for Rural Pennsylvania estimated~     that 27% of population of PA live in one of Pennsylvania's 48 rural counties. Under this~     estimate, there are over 43,000 individuals affected with chronic HCV living in rural~     Pennsylvania. Rural county residents often experience barriers to health care by having fewer~     primary care providers and limited specialty care physicians available to them to address~     their healthcare needs.~      RQ1: Will the community based delivery system for Hepatitis C screenings see an increase in~     positivity rates?~      HO1: There is no relationship between the community based delivery system with an increase in~     the Hepatitis C screening positivity rates.~      HA1: There is a relationship between the community based delivery system with an increase in~     the Hepatitis C screening positivity rates.~   "
28636|NCT03192176|"~     This study is to determine the effects of different doses and dosing regimens of ESN364 on~     the frequency and severity of hot flashes. The treatment will be administered for 12 weeks to~     postmenopausal women, ages 40 to 65, suffering at least 50 moderate to severe hot flashes per~     week.~   "
28404|NCT03195192|"~     This is an open-label, multicenter study in patients with metastatic breast cancer who are~     candidates for standard first line treatment with palbociclib or ribociclib plus endocrine~     therapy. To be eligible, patients must have received no prior chemotherapeutic or hormonal~     regimen for metastatic disease. However, patients may still be considered eligible if they~     have already started treatment with endocrine therapy (an aromatase inhibitor or fulvestrant)~     plus palbociclib or ribociclib for no longer than 4 weeks prior to study enrollment, as long~     as they meet all other eligibility criteria. Eligible patients must have had a diagnostic~     biopsy of the metastatic lesion no more than 4 months prior to study enrollment and with~     sufficient tissue to complete the proposed biomarker analysis. Patients who develop disease~     progression within the first 12 months of starting palbociclib or ribociclib plus endocrine~     therapy will be eligible for an optional additional tissue biopsy at time of disease~     progression to repeat the analysis at time of disease progression and obtain real-time~     (10-14-day turn-around) multi-omic data produced under College of American Pathologist~     (CAP)/Clinical Laboratory Improvement Amendments (CLIA) development and/or compliant~     practices.~   "
28405|NCT03195179|"~     Pelvic fracture urethral injuries (PFUI) occur in up to 10% of pelvic fractures. It remains~     controversial whether initial urethral realignment after PFUI decreases rates of urethral~     obstruction and the need for subsequent urethral procedures.~      The proposed prospective multi-institutional cohort study should determine the utility of~     acute urethral realignment after PFUI.~   "
28406|NCT03195166|"~     Compared to single-dose spinal anesthesia, continuous spinal anesthesia using small titrated~     doses of local anesthetic, was safe, efficient and provided better hemodynamic profile in~     elderly patients.~      The aim of this study was to investigate the hemodynamic effects of continuous spinal~     anesthesia in elderly patients undergoing knee arthroplasty.~      Investigators use the FloTrac sensor/Vigileo haemodynamic monitoring system to assess~     modification blood pressure, stroke volume and cardiac output during anesthesia and specialy~     after every bolus of spinal anesthesia, after inflating the tourniquet and after putting it~     off.~      they recorded number of hypotension episodes, ephedrine bolus and consumption until 2 hours~     after the end of surgery.~   "
28407|NCT03195153|"~     Diabetes mellitus is associated with an increased risk of cardiovascular disease. Substantial~     clinical and experimental evidence suggest that both diabetes and insulin resistance cause a~     combination of endothelial dysfunctions, which may diminish the anti-atherogenic role of the~     vascular endothelium. Therefore, in patients with diabetes or insulin resistance, endothelial~     dysfunction may be a critical early target for preventing atherosclerosis and cardiovascular~     disease. It has been implicated as an independent risk factor for cardiovascular disease and~     premature cardiovascular mortality for patients with type 1 and type 2 diabetes mellitus, as~     well as for patients with essential hypertension. A complete biochemical understanding of the~     mechanisms by which hyperglycemia causes vascular functional and structural changes~     associated with the diabetic milieu still eludes us. In recent years, the numerous~     biochemical and metabolic pathways postulated to have a causal role in the pathogenesis of~     diabetic vascular disease have been distilled into several unifying hypotheses. The role of~     chronic hyperglycemia in the development of diabetic microvascular complications and in~     neuropathy has been clearly established. However, the biochemical or cellular links between~     elevated blood glucose levels, and the vascular lesions remain incompletely understood. A~     number of trials have demonstrated that statins therapy as well as angiotensin converting~     enzyme inhibitors is associated with improvements in endothelial function in diabetes.~     Although antioxidants provide short-term improvement of endothelial function in humans, all~     studies of the effectiveness of preventive antioxidant therapy have been disappointing.~     Actually, control of hyperglycemia thus remains the best way to improve endothelial function~     and to prevent atherosclerosis and other cardiovascular complications of diabetes.~   "
28408|NCT03195140|"~     A 6-week crossover study will compare PLGS to SAP outcomes in adults and youth > 6 years old~     with type 1 diabetes (T1D).~   "
28409|NCT03195127|"~     As the general population ages and technology advances, many who suffer from catastrophic~     critical illness (i.e. septic shock, respiratory failure, Acute Respiratory Disease Syndrome)~     survive only to find themselves severely physically debilitated and compromised from a~     pulmonary standpoint, requiring assistance from a mechanical ventilator in order to breath.~     Oftentimes, these patients require a long course of physical rehabilitation and ventilator~     support. These patients frequently remain ventilator dependent for greater than 3 weeks, and~     are thus referred to as requiring prolonged mechanical ventilation (PMV).~      Older patients are at significantly higher risk for requiring PMV for reasons that are not~     entirely clear, but which may include physical deconditioning, impaired cardiopulmonary~     physiology, and cognitive or behavioral disturbances.~      The purpose of this study is two fold: 1. to characterize the functional phenotype of~     ventilator dependent, and recently ventilated patients with respect to general strength,~     endurance, balance, and pulmonary functioning and body composition. 2. To pilot test a~     rehabilitation protocol that targets improving this populations disabilities through~     exercises focused on improving strength, endurance, balance, and pulmonary functioning.~   "
28410|NCT03195114|"~     The objectives of this study are to: a) evaluate and correlate the severity of paravalvular~     leak (PVL) assessed by both cardiac MRI and transthoracic echocardiography (TTE) after~     transcatheter aortic valve replacement (TAVR) with Medtronic Evolut-R or Evolut PRO~     bioprostheses; b) assess the inter and intraobserver variability of both imaging methods; and~     c) correlate the severity of PVL with post-TAVR changes in LV remodeling and clinical~     outcomes.~   "
28411|NCT03195101|"~     Many surgical approaches for excision of orbital tumors have been described. These approaches~     do not allow access to all orbital quadrants. Furthermore, some of these approaches are~     technically difficult, associated with long morbidity and post operative pain, having high~     rate of complications or having unacceptable cosmetic appearance. the investigators present~     the transconjunctival approach as an alternative procedure that allows access to orbital~     tumors in different locations as well as less morbidity and better cosmetic results~   "
28412|NCT03195088|"~     The primary objective of this trial is to investigate the safety and tolerability of single~     rising doses of BI 473494 in healthy male subjects.~      The secondary objective is the exploration of PK including dose proportionality, and PD of BI~     473494 after single dosing.~   "
28413|NCT03195075|"~     Endoscopic ultrasonography is a widely accepted modality for the diagnosis of~     gastrointestinal and pancreatic-biliary diseases.~      Endoscopic ultrasonography-guided biliary drainage has attracted attention as an alternative~     procedure to percutaneous trans-hepatic biliary drainage, with a technical success between~     75%-100% and with low complication rate. Other important advantage of endoscopic~     ultrasonography-guided biliary drainage compared with external percutaneous trans-hepatic~     biliary drainage is better quality of life due to the internal placement of the stent.~   "
28637|NCT03192163|"~     This study will use a survey to examine relationships between culture, race, and ethnicity~     with treatment preferences and perceptions for acne vulgaris.~   "
28414|NCT03195062|"~     In parallel to the dramatic rise in metabolic diseases and diabetes observed over the past~     fifty years, the generalization of added sugar in processed food led to a marked increase in~     fructose consumption in almost all countries, and epidemiological studies demonstrated that~     the consumption of sugar-sweetened beverage (containing at least 50% of fructose) is~     associated with the development of diabetes, hepatic steatosis, dyslipidemia and obesity.~      The objective of the study is to measure the amount of fructose that escape first-pass~     hepatic extraction after oral ingestion (fructose+glucose), and gain insights into its~     metabolic fates with the use of tracers.~   "
28415|NCT03195049|"~     Exchange transfusion is effective and considered to be safe procedure ; however, it is not~     without risks. Complications have been reported and mortality rates vary from 0.5 to 3.3%.~     therefore ,the current recommendation for performing exchange transfusion are based on~     balance between the risks of encephalopathy and complications related to the procedure .~   "
28416|NCT03195036|"~     There is substantial evidence that early childhood development (ECD) programming can improve~     child health and development outcomes. An important component of ECD programming is~     supporting positive parenting and early stimulation practices. While many parents could~     benefit from such programming, mothers that are HIV-infected may particularly benefit given~     the higher risks of poorer child development among HIV-exposed children. Catholic Relief~     Services (CRS) in Cameroon is implementing the Key Interventions to Develop Systems and~     Services (KIDSS) ECD program for HIV-exposed children. The program will include home-,~     facility-, and community-based components. This impact evaluation will ascertain to what~     extent the KIDSS home-based component of the ECD model affects attainment of age-appropriate~     developmental milestones (measured by the Ages and Stages Questionnaire 3 (ASQ-3)) in~     HIV-exposed children in Cameroon. The study design is a cluster-randomized controlled trial~     with a cohort of 200 mother/child dyads across 10 study clinics. HIV+ mothers will be~     recruited during pregnancy and their children will be followed up until 18 months of age. The~     intervention group will receive regular home-based ECD services focused on positive parenting~     and early stimulation as well as exposure to facility- and community-based ECD programming.~     The control group will only have exposure to the facility- and community-based ECD~     programming. Randomization occurs at the clinic (cluster) level.~   "
28417|NCT03195023|"~     This study evaluates the effect of renin-angiotensin blockers on chronic kidney disease~     progression in elderly (>65 years old) patients with non-proteinuric nephropathies. Half of~     the patients will receive angiotensin converting enzyme inhibitors, while the other half will~     not receive them. Renal function, proteinuria and cardiovascular events will be follow up~     during a three year period.~   "
28418|NCT03195010|"~     This pilot clinical trial compares the safety of two different platelet transfusion~     thresholds among patients with blood cancer or treatment-induced thrombocytopenia whose~     condition requires anticoagulant medication (blood thinners) for blood clots. Giving~     relatively fewer platelet transfusions may reduce the side effects of frequent platelet~     transfusions without leading to undue bleeding.~   "
28419|NCT03194997|"~     Breast cancer is one of the most common types of cancer in Brazil, and its treatment, namely~     surgery, chemotherapy, radiotherapy or hormone therapy, has consequences and side effects~     that significantly affect the quality of life and associated physical and psychological~     factors. The practice of physical activity, in turn, may play a beneficial role in these~     factors, and help the recovery of the patient in relation to the consequences of the~     treatments. Two types of physical activity can be addressed in the context of breast cancer;~     Dance and the Pilates method. Thus, the objective of the present study will be to analyze the~     impact of Pilates practice and dance on quality of life and on psychological and physical~     factors in patients undergoing adjuvant treatment of breast cancer. Patients older than 18~     years who are in adjuvant treatment, namely, chemotherapy, radiotherapy and / or hormone~     therapy at the Oncology Research Center - CEPON, will be invited to be part of the study.~     With a randomized clinical trial of three arms, the patients will be submitted to 16 weeks of~     intervention, and randomized in 3 groups: (A) belly dance protocol group; (B) Pilates method~     protocol group, and (C) control group who will continue with their routine activities. Sample~     randomization will be conducted in confidence by one of the researchers in a specific~     computer program. Information about personal and clinical characteristics, quality of life,~     psychological factors (depressive symptoms, body image, self-esteem, optimism, perceived~     stress, fatigue, pain, sexual function and sleep quality) and physical factors~     (cardiorespiratory fitness, balance , Posture, upper limb functionality and presence of~     lymphedema). All information will be collected before and after the intervention period.~     Statistical analysis will use the statistical package SPSS - IBM, version 20.0. Firstly,~     descriptive statistics (mean, standard deviation and percentage) will be used in order to~     know the data, and then the Anova two way test with repeated measurements and Sydak~     Comparison Test, in order to analyze the data. Groups of the Pilates method, of the dance and~     control group. Significance level of 5%.~   "
28420|NCT03194984|"~     To evaluate the effectiveness in terms of color variation, patient satisfaction, absolute~     risk and intensity of dentin sensitivity due to dental bleaching in the office with 35%~     hydrogen peroxide (Whiteness HP Automixx 35%, FGM) and Opalescence Boost 38% ( Ultradent,~     South Jordan, UT, USA) in the same arch in patients of different age groups: 18 to 25 years~     and 40 to 65 years. Data will be collected, tabulated and submitted to statistical analysis~   "
28421|NCT03194971|"~     This study will assess whole brain samples from glioblastoma patients at autopsy to determine~     the underlying pathological signatures of tumor treatment fields at autopsy.~   "
28422|NCT03194958|"~     Using a 2x2 randomized factorial design, we will conduct a statewide field trial in Missouri~     to compare the relative and combined effects of these two strategies for augmenting an~     existing, evidence-based tobacco quitline program. Among 2000 low-income smokers, half will~     receive standard Missouri quitline services and half will receive new Specialized Quitline~     services targeted to this group. In each of these groups, half also will receive calls from a~     trained navigator to help them address unmet Basic Needs and the accompanying psychological~     distress that act as barriers to smoking cessation.~   "
28431|NCT03194841|"~     The purpose of this study was the development, and testing of a HF application that was used~     to provide self-care support to HF patients through a smartphone device. The study appraised~     current available literature on HF to determine best practices for promoting self-care of HF~     through direct communication with individuals with HF living at home. For the purpose of this~     study, smart phone communication was utilized. Smart phone applications allow patients to~     transmit physiological data, such as weight, blood pressure, heart rate, and symptom data to~     healthcare providers. Using a secure website, a healthcare worker can access the information~     and contact the patient via the mobile phone when their data is out of normal range. This~     study was novel in its approach from what is traditionally offered in that it supported~     patient self-care decisions by promoting symptom monitoring and offered both tactical and~     situational skills strategies through at the point education.~   "
28423|NCT03194945|"~     Short-term intensive insulin therapy(SIIT) is able to reverse β cell dysfunction and induce~     glycemic remission in patients with newly diagnosed type 2 diabetes. However, proportion of~     patients with response gradually decreases over time. There is no consensus on which~     treatment should be given in order to maintain the benefit in glycemic control and β cell~     recovery. In this multi-center, randomized, controlled study, effects of various sequential~     treatments ( metformin, linagliptin and combined with both drugs) on long-term blood glucose~     control as well as preservation of β cell function after SIIT were investigated.~      In total, 448 patients with newly diagnosed type 2 diabetes who meet the inclusive criteria~     will be enrolled in eight centers in China. After baseline assessments, all patients will be~     treated with insulin pump to achieve and maintain euglycemia for 2 weeks. After completion of~     intensive treatment, insulin pump will be stopped. Different treatments will be applied to~     patients for 48 weeks according to randomization: Group A: Linagliptin 5 mg Qd + Metformin~     0.5 g bid; Group B: Linagliptin 5 mg Qd; Group C: Metformin 0.5 g bid; Group D: No oral~     drugs. Primary endpoint is proportion of patients achieving glycosylated hemoglobin A1C <7%~     at the end of the study. Secondary endpoints include proportion of patients achieving~     glycosylated hemoglobin A1C <6.5% at the end of study; differences in β-cell function ,~     insulin sensitivity, GLP-1 and glucagon secretion among treatment groups, and differences in~     adverse events among treatment groups.~   "
28424|NCT03194932|"~     The purpose of this study is to test the safety of venetoclax and to find the highest dose of~     venetoclax that can be given safely when it is combined with one or two chemotherapy drugs~     (cytarabine or cytarabine and idarubicin). This study tests different doses of venetoclax to~     see which dose is safer in children with leukemia.~      PRIMARY OBJECTIVE: Determine a tolerable combination of venetoclax plus chemotherapy in~     pediatric patients with relapsed or refractory acute myeloid leukemia (AML) or acute leukemia~     of ambiguous lineage. The primary endpoint is the maximum tolerated combination (MTC) of~     venetoclax plus chemotherapy.~      SECONDARY OBJECTIVE: Estimate the overall response rate to the combination of venetoclax and~     chemotherapy in pediatric patients with relapsed or refractor AML or acute leukemia of~     ambiguous lineage. The secondary endpoints are the rates of complete remission (CR) and~     complete remission with incomplete count recovery (CRi) for patients treated at the MTC.~   "
28425|NCT03194919|"~     The primary purpose of the current study is to test the effect of providing users of~     automated web-based smoking cessation interventions with the option of negotiating and~     re-negotiating the quit date.~   "
28426|NCT03194906|"~     Children with brain tumors who have had radiation therapy are at risk for problems with~     attention, memory, and problem solving. Such problems may cause difficulty in school and~     daily life. Memantine, the drug being used for this study, is not yet approved for use in~     children by the U.S. Food and Drug Administration. However, studies have shown some~     improvements in memory for patients with dementia, Attention Deficit Hyperactivity Disorder,~     and autism. Scientists have also used this medication for adult cancer patients receiving~     radiation therapy with results showing less cognitive declines over time compared to patients~     taking a placebo (inactive pill). These studies have also shown few side effects.~      This is a pilot/feasibility study and the first known study involving children with a cancer~     diagnosis or brain tumor.~      PRIMARY OBJECTIVES:~        -  To estimate the participation rate in a study of memantine used as a neuro-protective~          agent in children undergoing radiotherapy for localized brain tumors (low grade glioma,~          craniopharyngioma, ependymoma, or germ cell tumor)~        -  To estimate the rate of memantine medication adherence~        -  To estimate the rate of completion of cognitive assessments~      SECONDARY OBJECTIVES:~        -  To estimate the effect size of change in neurobehavioral outcomes (cognitive, social,~          quality of life, neurologic) associated with memantine~        -  To evaluate the frequency and nature of memantine side effects as measured by the~          Systematic Assessment for Treatment Emergent Events (SAFTEE)~   "
28427|NCT03194893|"~     The purpose of this study is to provide continued treatment with alectinib or crizotinib as~     applicable to participants with ALK- or RET positive cancer who were previously enrolled in~     any Roche-sponsored alectinib study and who are deriving continued clinical benefit from~     alectinib or crizotinib in the parent trial at the time of parent trial closure.~   "
28428|NCT03194880|"~     Two new rapid HIV tests by Alere™ have the potential to substantially decrease the window~     period for rapid tests. First, the Alere™ HIV Combo is a rapid fourth generation test. The~     performance in a laboratory based setting was recently assessed at the Thai Red Cross~     Anonymous Clinic Laboratory in Bangkok, Thailand (personal communication). Of 50 confirmed~     acute HIV samples, Alere™ HIV Combo could detect 37 (74%), while none of these 50 cases could~     be identified by the currently used third generation tests. These data have not yet been~     published, but the preliminary results indicate a very favorable performance of the Alere™~     HIV Combo in a facility-based laboratory setting.~      Second, the Alere™ q HIV-1/2 Detect is a qualitative, cartridge based, nucleic acid~     amplification test designed for Point of Care use. Data from several early infant diagnosis~     studies in Sub-Saharan African countries have assessed the performance of the Alere™ q~     HIV-1/2 Detect. The test was performed in the field, by a range of health professionals, from~     nurses and laboratory technicians to medical doctors. The pooled analysis showed a~     sensitivity of 99.07% (95%CI 95.48 - 99.95%) and a specificity of 99.94% (99.72-100%).~   "
28429|NCT03194867|"~     Primary Objectives:~        -  To evaluate the safety and tolerability of the combination of isatuximab (also known as~          SAR650984) and cemiplimab (also known as REGN2810) in patients with relapse/refractory~          multiple myeloma.~        -  To compare the overall response of the combination of isatuximab and cemiplimab versus~          isatuximab alone in patients with RRMM based on International Myeloma Working Group~          (IMWG) criteria.~      Secondary Objectives:~        -  To evaluate the efficacy as assessed by clinical benefit rate (CBR), duration of~          response (DOR), time to response (TTR), progression free survival (PFS), and overall~          survival (OS).~        -  To assess the pharmacokinetics (PK) of isatuximab and cemiplimab when given in~          combination.~        -  To assess the immunogenicity of isatuximab and cemiplimab when given in combination.~   "
28430|NCT03194854|"~     Subjective well-being is a positive state affairs in six domains of life: interpersonal,~     community, occupational, physical, psychological, and economic (I COPPE). The purpose of the~     study is to evaluate the effectiveness, feasibility, and acceptability of an online~     intervention named Fun For Wellness (FFW), designed to promote skills and self-efficacy in~     the multidimensional I COPPE domains of life.~   "
28433|NCT03194815|"~     A randomised phase II double-blinded placebo-controlled trial designed to explore the utility~     of immunotherapy for patients with acute psychosis associated with anti-neuronal membranes~     (NMDA-receptor or Voltage Gated Potassium Channel).~      Primary objective: To test the efficacy of immunotherapy (IVIG and rituximab) for patients~     with acute psychosis associated with anti-neuronal membranes.~      Secondary objective: To test safety of immunotherapy (IVIG and rituximab) for patients with~     acute psychosis associated with anti-neuronal membranes.~   "
28434|NCT03194802|"~     The aims of the study are to determine whether an online drug tapering program can lead to~     successful drug tapering in hypnotic dependent insomnia and whether such tapering is~     associated with improved daytime functioning and sleep.~   "
28435|NCT03194789|"~     FGBMM (footwear generated biomechanical manipulation) effects neuromuscular patterns of~     pelvic muscles. While there have been no published studies to our knowledge investigating the~     effect of FGBMM on urinary incontinence, FGBMM causes perturbations in balance and gait that~     create dynamics similar to dynamic lumbosacral stabilization exercises. The investigators~     propose that FGBMM induces the same bio-mechanical improvements as LPSE (lumbopelvic~     stabilization exercises) which have shown benefit for incontinence. Instead of instructing~     patients to co-contract the lower trunk and pelvic floor muscles as commonly done for LPSE,~     the shoes used in FGBMM can be calibrated in a way that causes this co-contraction to occur~     without the patient realizing. Beneficial pelvis and spine positioning can also be~     accomplished by strategic placement of the pods without having to instruct the patient on~     complicated maneuvers. Capitalizing on the excellent adherence and clinical benefits of FGBMM~     on related conditions, the investigators propose to evaluate the effects of FGBMM in addition~     to pelvic floor therapy for improving the symptoms of stress urinary incontinence in an urban~     inner city population.~   "
28436|NCT03194776|"~     This study is designed to determine whether LLG783 displays the clinical safety and efficacy~     profile, after multiple i.v. doses, to support further development in patients with PAD and~     intermittent claudication.~   "
28437|NCT03194763|"~     Congenital heart defects are the most frequent manifestation of congenital diseases (8 per~     1000 live births). Imaging modalities play an increasing role in their diagnosis, follow-up,~     and pre/post-surgery check-up. Echocardiography usually provides a first line diagnosis, but~     Coronary CT Angiography (CCTA) also demonstrated its usefulness whenever accurate modelling~     of anatomic structures is required.~      CCTA is well defined for adult patients. This is not the case for paediatric population,~     which rises two main difficulties:~        -  The use of ionising radiation in young subjects involves a very radio-sensitive~          population, potentially subject to multiple exams during their follow up.~        -  Technical issues related to young patients: No breath-holding, uncontrolled movements~          during acquisition, very high heart rates (making ECG gating more complex) and very~          small structures.~      These conditions usually result in a deteriorated image quality or in radiation dose increase~     (retrospective gating). These two outcomes are not acceptable for both, clinician and~     patient.~      In this study, investigators make the hypothesis that despite difficult conditions stated~     above, ultra-low dose acquisitions may results in diagnostic quality acquisition, thanks to~     state of art CT technologies combined with acquisition parameters specially designed for that~     purpose.~      Investigators aim to demonstrate feasibility and performances of such exams.~   "
28438|NCT03194750|"~     Renal failure and resuscitation measures in critically ill patients can result in fluid~     overload. Fluid overload in renal failure patients can cause harmful effects like pulmonary~     edema, anasarca and congestive cardiac failure exacerbations among other complications. These~     have been associated with increased time on the ventilator, increased length of stay in the~     ICU, and higher overall mortality for patients requiring dialysis in the ICU.~      The current standard of care for adjusting fluid removal rates in patients on continuous~     renal replacement therapy relies on clinical judgement. Clinicians take into account factors~     like the patient's condition, vasopressor requirements, kidney function, total intake and~     outputs, vital signs, and physical examination findings when making daily changes to fluid~     removal rates on dialysis machines. Such assessment is highly subjective and can be~     imprecise/inaccurate leading to hypotension and hemodynamic instability in a critically ill~     patient.~      Use of conventional ultrasound by physicians to assess volume status using compressibility of~     the inferior vena cava has been shown to be a reliable predictor of volume status and can~     help guide therapy. Such use makes bedside volume assessment a non-invasive, rapid,~     repeatable point of care tool that can provide objective data to guide fluid removal~     determine velocity of fluid removal and help identify patients at risk of hypotension and~     hemodynamic instability during the process of fluid removal. Apart from rare possible local~     allergic reactions to ultrasound jelly and transient local discomfort, the disadvantages are~     minimal. Ultrasonography has been considered a safe imaging modality. This protocol will~     measure inferior vena cava compressibility using the General Electric VScan with Dual Probe,~     which has FDA approval for abdominal and vascular imaging in humans.~   "
28439|NCT03194737|"~     Assess feasibility and safety of the Prostatic Urethra Lift (PUL) procedure in patients with~     acute urinary retention secondary to benign prostatic hyperplasia (BPH).~   "
28440|NCT03194724|"~     The relationship between infections and malnutrition is synergistic, each further~     compromising the outcome of the other. Malnutrition compromises natural immunity leading to~     increased susceptibility to infections, more frequent and prolonged disease episodes, and~     increased severity of disease. Likewise, infections can aggravate or precipitate malnutrition~     through decreased appetite and food intake, nutrient malabsorption, nutrient loss or~     increased metabolic needs. Severe malnutrition often masks symptoms and signs of infectious~     diseases making prompt clinical diagnosis and treatment very difficult. Another issue is that~     infections (as well as overweight and obesity status) affect nutritional biomarkers making it~     difficult to assess the real magnitude of some nutritional problems. This is the case of~     vitamin A. Vitamin A deficiency is defined to be of severe public health importance if 20% or~     more of a defined population has a serum retinol concentration of less than 0.7 µmol/L.~   "
28441|NCT03194711|"~     The single center retrospective study evaluates the acute and long term outcomes of~     bioabsorbable drug-eluting scaffolds (BVS) implantation in 50 consecutive coronary artery~     disease (CAD) patients using optical coherence tomography (OCT) imaging.~   "
28455|NCT03194529|"~     The goal of this study is to evaluate the safety of Fecal Microbiota Transplantation (FMT) in~     children with Crohn's disease who are in remission. Safety will be the primary endpoint and~     Pediatric Crohn's Disease. Pediatric Crohn's Disease Activity Index (PCDAI) with other~     secondary endpoints including changes in gut microbial diversity will also be studied. All~     children will receive the equivalent of 50g of stools from a healthy donor into the jejunum~     through upper endoscopy. Also, 1-2 additional mucosal biopsies will be collected during~     patient's routine (standard of care) endoscopy. Subjects will have a total of 5 study visits~     within 24 weeks including phone call follow up on Day 7 after FMT.~   "
28442|NCT03194698|"~     Dry eye disease (DED) is a common condition that causes ocular discomfort and reduces visual~     acuity. The two categories of DED are evaporative dry eye and aqueous deficient dry eye. Both~     conditions can involve pathology of the meibomian glands, lacrimal glands, lids, tear film~     and surface cells. Meibomian gland dysfunction (MGD) is the leading cause of evaporative dry~     eye and contributes to aqueous deficient dry eye. The goal of MGD therapy is to provide long~     term improvement of symptoms for patients by improving the quality of meibum, increasing~     meibum flow, improving tear film stability and decreasing inflammation.~      Commonly used therapies include preservative free drops, omega-3 fatty acid supplementation,~     topical cyclosporine, serum tears, topical azithromycin, oral doxycycline, moisture chambers,~     intraductal probing, lib margin exfoliation, automated thermal pulsation, warm compresses,~     among other. Despite this variety of symptoms, patients often do not experience complete or~     long term relief of symptoms.~      Forced meibomian gland expression (MGX) has been shown to be an effective method of~     rehabilitating meibomian glands and improving dry eye symptoms. The eyelid margins are~     forcefully compressed to express gland contents. Research has shown improvement in patient~     symptoms with the use of MGX.~      Intense pulsed light (IPL) have been used in dermatology to treat various conditions.~     Patients with DED who have tried other therapies and found no relief, often resort to IPL as~     a last resort. Research has shown IPL alone may be effective in improving patient symptoms.~     In addition, such studies have failed to show significant adverse events with the use of IPL.~      Here, we propose a prospective, randomized, case controlled clinical pilot study to examine~     the efficacy for both subjective and objective measures. 20 patients with DED will be~     recruited and will be randomly assigned to one of two groups: MGX alone or MGX with IPL.~     Objective measures will include tear cytokine levels, impression cytology, meibography, tear~     osmolarity and others. Subjective measures will include quality of life screening tools.~      We hypothesize that the use of MGX with IPL will lead to greater improvement in subjective~     dry eye symptoms and objective measures. Given the lack of adverse effects reported in the~     literature, we do not anticipate adverse effects in our study.~      Rochester staff Drs. Faustch and Bourne are providing clinical research advice but have no~     contact with subjects or biospecimens.~   "
28443|NCT03194685|"~     A Phase 1/2a dose escalation and dose ranging study of FF-10101-01 in subjects with relapsed~     or refractory acute myeloid leukemia to determine the safety, tolerability, PK and~     preliminary efficacy. A total of 9 cohorts will be enrolled in Phase 1 to establish the~     Maximum Tolerated Dose (MTD). Phase 2a will consist of up to 3 dose levels (high, medium, and~     low) of which subjects with FLT3 mutations will randomly be assigned.~   "
28444|NCT03194672|"~     Randomized trial of a rapid repeat pregnancy prevention program for adolescent mothers.~      Five hundred adolescent mothers from central Ohio will be enrolled--half will be assigned to~     an intervention that features nurses and social workers providing extra assistance during~     late pregnancy and the early postnatal period and half will be assigned to a standard of care~     intervention.~      OhioHealth is the lead entity. Nationwide Children's Hospital serves as the local independent~     evaluator.~      This federally funded contract is supported by the Family and Youth Services Bureau.~   "
28445|NCT03194659|"~     The purpose of this study is to determine whether choline supplementation influences the~     availability of docosahexaenoic acid throughout pregnancy.~   "
28446|NCT03194646|"~     The study is performed to assess the efficacy and safety of Vilaprisan in subjects with~     uterine fibroids compared to standard of care~   "
28447|NCT03194633|"~     Chronic kidney disease (CKD) and hypertension are two closely related common chronic diseases~     that have serious implications to human health. Hypertension is a major cause for progression~     of renal disease and a risk factor for cardiovascular disease (CVD). Control of Blood~     Pressure (BP) to target is now considered to be the main goal in the treatment of patients~     with CKD.~      In clinical practice, it is difficult for CKD patients with hypertension to achieve systolic~     BP (SBP) or diastolic BP (DBP) goal; oftentimes, calcium channel blocker (CCB) class of~     drugs, for example, nifedipine gastrointestinal therapeutic system (GITS), is used in such~     patients. Previous data have demonstrated nifedipine to be having a significant dose-response~     relationship; that is, nifedipine 60 mg provided better BP reduction than 30 mg. However,~     there are limited studies that have evaluated the efficacy and tolerability of nifedipine~     GITS 60 mg in Chinese CKD patients with hypertension. Hereby, the objective of this study is~     to evaluate the effectiveness and tolerability of nifedipine GITS 60 mg treatment in a large~     cohort of CKD patients with uncontrolled hypertension.~   "
28448|NCT03194620|"~     The objectives of this study are to i) describe the absorption, distribution, metabolism and~     excretion (ADME) and pharmacokinetic parameters of selected dietary (poly)phenols in humans;~     and ii) to compare the ADME and pharmacokinetic parameters of selected dietary (poly)phenols~     in humans.~   "
28449|NCT03194607|"~     Low back pain is a leading cause of medical consultations in France and in other~     industrialized countries. Although spinal surgery is a recognized treatment, to date, its~     impact has only been assessed using subjective or declarative criteria. Yet, in many~     orthopaedic diseases, it has been shown that the evaluation of functional capacities,~     including walking speed, is particularly useful to study the impact of these diseases and~     their treatment. To date, no study has attempted to assess the impact of spinal surgery by~     evaluating 1) the functional capacities of patients and 2) spatio-temporal parameters of~     locomotion and joint dynamics. The investigators hypothesize that spinal surgery in patients~     with symptomatic lumbar spinal stenosis should lead to an improvement in quantifiable~     locomotion parameters, and in particular walking speed. Walking speed is a quantitative~     measurement, which could reflect the degree of functional impairment of the patient before~     and after surgery.~   "
28450|NCT03194594|"~     Ketamine and dexamethasone have been known to be effective postoperative pain. Many studies~     also have reported these two drugs might change mood such as depression. This study aimed to~     investigate the effect of each drug individually with their combination on perioperative~     change of mood in patients undergoing gynecologic surgery~   "
28451|NCT03194581|"~     This study will evaluate the impact of repeated normoxic challenges on cerebral oxygenation~     as a measure of the effect of blood loss on DO2 during surgical procedures.~   "
28452|NCT03194568|"~     This study will assess whether Anterior Vertebral Tethering is a safe and feasible method of~     anterior approach surgery for spinal deformity in pediatric idiopathic scoliosis.~   "
28453|NCT03194555|"~     This proof-of-concept study evaluates ALLOD-2 for the prevention of episodic migraine.~      The investigational product (ALLOD-2), is a combination of two marketed drugs. Both drugs are~     used at much lower doses than the doses used for the approved indications.~      The combination is a First-in-Class drug due to its new and unique mechanism of action.~   "
28454|NCT03194542|"~     This is a Phase 2, multicenter, open-label study to evaluate the efficacy and safety of~     luspatercept in subjects with MPN-associated myelofibrosis and anemia with and without~     RBC-transfusion dependence. The study is divided into a Screening Period, a Treatment Period~     (consisting of a Primary Phase, a Day 169 Disease Response Assessment, and an Extension~     Phase), followed by a Posttreatment Follow-up Period.~   "
28456|NCT03194516|"~     Men with indolent forms of prostate cancer are managed expectantly using active surveillance,~     with a goal of delaying treatment and its deleterious side effects. However, almost 50% of~     men experience progression with this approach and require treatment. Elevated body mass index~     (BMI) is associated with a dramatically increased risk of progression to higher grade~     prostate cancer. The goal of the proposed research is to gather preliminary data evaluating~     the effects of a promising dietary strategy to delay cancer progression in overweight and~     obese prostate cancer patients undergoing active surveillance. The investigators hypothesize~     that a ketogenic diet intervention may reduce BMI and favorably alter the prostate~     microenvironment.~   "
28457|NCT03194503|"~     The purpose of the study is to determine the efficacy of video coaching training for~     neonatology attending providers on tracheal intubation procedural outcomes in neonatal ICUs.~   "
28458|NCT03194490|"~     The purpose of this study is to assess the benefit of adding stretching exercises to cervical~     mobilization and cervical range of motion exercises on cervical range of motion, pain, pain~     threshold, level of disability and patient satisfaction for patient with non-specific~     mechanical neck pain~   "
28459|NCT03194477|"~     Project Narrative This 3-city proposal seeks to address HIV disparities among young (ages~     15-24) Black men who have sex with men (YBMSM) in a multilevel intervention to identify,~     engage and retain, high-risk HIV-uninfected and HIV-infected urban YBMSM in the HIV~     prevention and treatment cascade. The mobile-enhanced engagement intervention (MEI) is driven~     by the expressed and self-determined needs of each HIV infected and uninfected participant~     and includes care navigation, engagement, treatment and adherence. MEI also includes a~     supplemental Screening, Brief Intervention, and Referral for Treatment (SBIRT), to support~     YBMSM who face barriers accessing substance use treatment. By building upon existing case~     management services and flexibility to be adapted across ages and maturity and for prevention~     services, this intervention has the ability to transform networks, HIV and prevention care in~     YBMSM in cities with very high primary and secondary HIV transmission.~   "
28460|NCT03194464|"~     This study investigates the effects of sub-maximal exercise to task-failure (e.g., fatigue)~     with the less involved, or so-called non-paretic hand, in people who have experienced a~     stroke. In previous work the investigators found that non-paretic hand exercise to~     task-failure increased excitability of the motor cortex in the more involved hemisphere and~     produced behavioral improvements in the unexercised paretic hand. Importantly, the magnitude~     of increased brain excitability is greater than what has been observed following brain~     stimulation with either repetitive transcranial magnetic stimulation (TMS) or transcranial~     direct current stimulation (tDCS) and lasts longer. This approach could be implemented in the~     clinical setting and could be accessible to a greater number of people than brain~     stimulation. The investigators' goals in the current study are to: repeat previous findings~     in a different group of participants and investigate the neural mechanisms that produce brain~     and behavioral facilitation in order to inform development of this approach for clinical~     implementation.~   "
28461|NCT03194451|"~     The main limitation in bone regeneration is the lack of vascularization of the newly shaped~     tissue. The main objective of this project is to check if the simultaneous differentiation of~     dental mesenchymal stem cells toward osteoblastic and endothelial lineage permits to obtain a~     new pre-vascularized tissue engineered bone construct.~      We will then evaluate the boosting effect of the conditionned medium on cell differentiation~     and production of a prevascularized bone construct.~   "
28462|NCT03194438|"~     The primary goal of this study is to determine the feasibility and acceptability of a 6-week~     multicomponent integrative therapy program, Urban Zen Integrative Therapy (UZIT), for adults~     with chronic, life-limiting cardiopulmonary disease. The secondary goal is to determine~     preliminary efficacy of UZIT in symptom management. Pulmonary hypertension (PH) presents an~     excellent model of a severe, life-limiting cardiopulmonary condition with high symptom burden~     and poor outcomes suitable for this scientific inquiry. Despite medical and pharmacological~     advances in the treatment, 50-55% of persons with PH will die within three years after~     diagnosis. Medical management often involves life-long complex pharmacological treatment~     requiring high levels of skill, knowledge, and social support. Clusters of bothersome~     symptoms such as chest pain, anxiety, insomnia, dyspnea, and fatigue can overwhelm patients'~     ability to manage daily activities and medication treatment regimens. Side effects of~     treatment induce additional noxious symptoms. The high prevalence of physical symptoms,~     depression, and anxiety among adults with PH confirmed in our prior work, can also lead to~     reduced (HRQoL). A literature search found no published report of complementary, integrative~     therapy interventions to alleviate symptoms in adults with PH. This study will use a single~     group repeated-measures design to address the feasibility and acceptability of the~     intervention and to explore preliminary efficacy.~   "
28463|NCT03194425|"~     Retrospective case-control study.~      A substantial number of patients do not respond favourably to sacral neurostimulation (SNS)~     although clinically, they appear to have the same lower urinary tract dysfunction~     characteristics as the ones with good responses. This may be due to methodological issues~     (lead position) or patient selection. The purpose of this study is to improve and standardize~     lead position, in order to increase the patient response to test stimulation and to SNS~     treatment, and to decrease adverse events.~   "
28475|NCT03194269|"~     This is an open-label, prospective, uncontrolled, single arm, post-marketing study of the~     long-term safety and performance of EARFOLD® Implantable Clip System.~   "
28476|NCT03194256|"~     This study is designed to examine how the nicotine content of cigarettes and the nicotine~     concentration and flavors in e-liquids influence responses to and use of these products in~     adolescent smokers. Participants will complete a total of six sessions (an in-person~     screening/baseline session and five lab sessions.~   "
28477|NCT03194243|"~     This is an observational prospective multicenter study of patients admitted for acute dyspnea~     in an emergency department of the participating centers in the Lorraine district.~      The primary objective is to assess the outcome of this population according to the cause of~     acute dyspnea as well as identify the predictors of this outcome, both overall and according~     to each acute dyspnea cause.~   "
28478|NCT03194230|"~     The purpose of this study is to evaluate whether the use of cervical dilators for cervical~     ripening in case of second trimester medical termination of pregnancy (TOP) is effective to~     reduce duration of labor.~   "
28464|NCT03194412|"~     This intervention study is a part of the FOCUS (Frailty Management Optimization Through EIP~     AHA Commitments and Utilization of Stakeholders Input) project which purpose is to critically~     reduce the burden of frailty in Europe by assisting those partners within the European~     Innovation Partnership for Active Healthy Ageing (EIPAHA) with commitments focusing on early~     diagnosis/ screening and/or management of frailty to achieve scalability.~      FOCUS aims to critically reduce the burden of frailty in Europe by developing methodologies~     and tools to assist entities focusing on early diagnosis, screening and management of frailty~     to achieve scalability. Frailty is a common clinical syndrome in older adults that brings an~     increased risk for poor health outcomes including falls, incident disability, hospitalization~     and mortality.~      The FOCUS Consortium brings together a multidisciplinary team of specialists from 10~     organizations in 6 countries - Italy, Poland, Portugal, Spain, Netherlands, United Kingdom -~     that will work on developing, piloting and disseminating methodologies and tools to assist~     entities focusing on early diagnosis, screening and management of frailty to achieve~     scalability.~      Wroclaw Medical University actively participates in all projects for the advances in science,~     entrepreneurship, technological innovation, both with public authorities, local governments,~     and enterprises. In FOCUS project, WMU is responsible for Evaluation of the project and~     collaborates with the others partners in Coordination of the project, Dissemination of the~     project, Synthesis of learning and realities of practice, Analysis and guidelines~     development, Creation of Network and Platform for knowledge exchange, Test of guidelines in a~     set of commitments (Work Package 7 - WP7).~      The outcomes of this proposal will offer significant potential improvements for innovative,~     coordinated and comprehensive community based prevention with regard to the optimisation of~     functional capacity tools to address pre-frailty, and for improving the management of~     frailty.~      The registered study has its own protocol developed by Wroclaw Medical University research~     team and will be implemented within WP7 of the FOCUS project.~   "
28465|NCT03194399|"~     In order to develop effective personalized healthcare service program for breast cancer~     rehabilitation, we designed this study using mobile phone and clinical intervention(feedback~     coaching).~   "
28466|NCT03194386|"~     Millions people, all over the world, are admitted in the Emergency Department after a trauma~     or simply to receive medical cares. In France, it represents 10 million patients. Probably~     because of stress associated with the event, 20% will suffer a combination of non-specifics~     symptoms which persist for many months and with daily life quality impairment. The~     investigators hypothesize that an early intervention, such as Eye-Movement, Desensitization~     and Reprocessing (EMDR) could be performed in the ED and could prevent the occurrence of~     these symptoms~   "
28467|NCT03194373|"~     The purpose of this study is to test the effectiveness (how well the drug works), safety, and~     tolerability of the investigational drug combination of palbociclib (Ibrance) plus~     carboplatin in patients with metastatic head and neck squamous cell cancer.~   "
28468|NCT03194360|"~     Delirium is one of main adverse events in ventilated patients who receive long-term usage of~     mono-sedative. Sequential sedation may reduce these adverse effects. This study aimed to~     evaluate incidence and risk factors for delirium in sequential sedation patients.~   "
28469|NCT03194347|"~     The aim of the planned research project is to find out the clinical significance of molecular~     genetic analyzes in gynecological malignomas. In particular, it will be investigated how the~     knowledge of a molecular-genetic finding affects the therapeutic decision of the physician.~     Furthermore, genetic changes in the tumor tissue will be compared with the changes in CTCs,~     DTCs and cfDNA.~   "
28470|NCT03194334|"~     Balanced vegetarian diets are popular and contain health-promoting characteristics. A~     balanced lacto-ovo-vegetarian diet differs in nutrient intake from an omnivorous diet, e.g.~     by increased intake of fibre, magnesium and antioxidants, but lower intake of omega-3 fatty~     acids and vitamin B12. However, the impact of reduced to near absent intake of carnitine,~     carnosine and creatine in a vegetarian diet is less well established and could be relevant in~     relation to muscle function, exercise capacity and sports performance. Few longitudinal~     intervention studies investigating the effect of a vegetarian diet on the availability of~     these compounds currently exist.~      This study aimed therefore to investigate the effect of of transiently switching omnivores~     onto a vegetarian diet for 6 months on muscle and plasma creatine, carnitine and carnosine~     homeostasis.~      We hypothesized that homeostasis of creatine and carnosine would be disrupted when their~     dietary intake was missing. For carnitine, however, we hypothesized that homeostasis can be~     maintained given its slow turnover rate and its presence in some non-meat nutrients. A second~     aim was to investigate whether supplementation of creatine and beta-alanine (the~     rate-limiting precursor of carnosine synthesis), concurrently with a lacto-ovo-vegetarian~     diet, was able to correct for potentially emerging deficiencies.~   "
28471|NCT03194321|"~     The purpose of this study is to demonstrate the safety of tacrolimus extended-release in HLA~     sensitized (HS, defined as panel reactive antibody ≥ 30%), kidney transplant recipients after~     desensitization with intravenous immunoglobulin (IVIG) and rituximab +/- plasma exchange~     (PLEX) per the standard of care with alemtuzumab induction.~   "
28472|NCT03194308|"~     Women who choose to conceive with an infected or unknown serostatus partner in HIV-endemic~     settings need prevention strategies to reduce periconception HIV acquisition risk. Women at~     high risk for acquiring HIV during pregnancy need risk reduction strategies to protect~     themselves and their babies. Evaluating uptake of and adherence to antiretrovirals as~     pre-exposure prophylaxis in this population is crucial to understanding whether and how this~     novel prevention strategy should be incorporated into HIV-risk reduction packages for at-~     risk women planning or with pregnancy.~   "
28473|NCT03194295|"~     Efforts to improve methadone maintenance outcomes are often thwarted by strong social~     networks that reinforce substance use and other risk behaviors. The proposed study the~     feasibility and preliminary efficacy of a practical community support intervention that~     employs an alteration model of social network change. The intervention works with patients~     and at least one drug-free family or friend to support participation in community activities~     designed to mobilize recovery support and expand personal drug-free social networks.~   "
28474|NCT03194282|"~     Poor balance capacity is one of clinical symptoms of stroke patient. The reason of loss~     balance capacity is motor impairment, as well as a diminished capacity to voluntarily shift~     body weight or to with stand external pertubations. An important determinant of activities of~     daily living performance is standing balance. Therefore, poor balance, or postural stability,~     is significant predictors the risk of fall. After a fall, the patient can experience~     psychological, physical, social, economic, and sometimes fatal effects. The injuries can~     reduce the patient's mobility as well as independence and influence quality of life. Postural~     movement patterns include three discrete control strategies: hip, knee, and ankle strategy.~     The ankle rocker is an important factor to maintain balance during standing and the ankle~     strategy restores the center of mass (CoM) to a position of stability through body movement.~     As a result, effective control of foot motion and ankle stability may decrease postural sway~     and the risk of fall in chronic stroke.~      The purpose of this study is to investigate the effects of the insole on balance capacity in~     chronic stroke.~   "
28482|NCT03194178|"~     The study team has made the hypothesis that the intensity of the phonatory disorders~     (rhinolalia), and of the maxillo-mandibular growth anomalies (facial morphology), may have~     negative effects on the quality of life of adolescents with Pierre Robin sequence.~      The investigators also want to assess the impact of 2 different surgical protocols of closure~     of the cleft palate (1 or 2 step(s)), on the current phonatory and morphology aspects. These~     2 protocols were performed, by 2 parisian clinical teams, that have now been merged at Necker~     hospital.~   "
28483|NCT03194165|"~     The purpose of this study is to develop population pharmacokinetic models for antiretroviral~     drugs in a pediatric population.~      The interest of these models is multiple :~        -  describe the pharmacokinetics of these drugs in children and explain the~          inter-individual variability of concentrations through covariates such as weight, age,~          sex, smoking status, co-treatments and bilirubin;~        -  estimate maximum, minimum and exposure concentrations from the individual~          pharmacokinetic parameters for each patient;~        -  propose adaptations of doses for certain classes of children (according to age, weight~          etc.) and individualize the doses.~   "
28484|NCT03194152|"~     This is a 2 parallel-arm randomized controlled study with free-living subjects on~     self-selected diets. The objective of this study is to compare the effects of two servings of~     peanuts with an isocaloric matched refined carbohydrate snack food on glucose, lipids and~     lipoproteins and cardiovascular health risk factors, satiety and gut microbiota in 250~     Chinese participants at risk for metabolic syndrome (overweight/obese, enlarged waist~     circumference, elevated LDL-cholesterol, prehypertension, and/or prediabetes).~      The investigators hypothesize that the inclusion of 2 serving of peanuts in the diet will~     decrease blood glucose, LDL-cholesterol, and improve satiety sanctification between meals and~     gut microbiota compared to the control group and baseline.~   "
28485|NCT03194139|"~     The study will be a double-blind, randomized, crossover, single-dose assessment of~     IV-administered GC4711 compared to GC4419 in healthy volunteers.~      Consenting subjects will undergo screening procedures within 28 days of the start of dosing.~     Pharmacokinetics (parent drug and major metabolites) will be assessed in plasma and urine~     from all subjects.~      Initially, a sentinel cohort of 4 subjects, will be enrolled; each eligible subject will~     receive single dose of GC4711 IV at dose of 30 mg over one hour. Following a clinical safety~     review by the Galera study team , if no safety concerns are identified after the last subject~     completes study participation, enrollment will continue in 2 stages to a crossover study~     design. In stage 1, 12 subjects will be enrolled and in stage 2, if no safety concerns are~     identified in stage 1 following a clinical safety review by the Galera study team, 20~     subjects will be enrolled. In both enrollment stages, eligible subjects in the crossover~     design will be randomized in 1:1 ratio to one of two treatment sequences: Test (GC4711) ->~     Ref (GC4419) or Ref (GC4419) -> Test (GC4711). On Day 1, subjects will receive the first~     treatment they were randomized to, and on Day 4 (following a washout), they will receive the~     second treatment. Subjects will be followed up for 2 days after the second treatment.~   "
28486|NCT03194126|"~     Reducing the time patients spend in the labor and delivery room saves money and reduces~     patient discomfort as well and reducing complications. We will compare two methods for~     inducing cervical maturation in order to shorten the time taken between administration of~     drugs and delivery.~   "
28487|NCT03194113|"~     The aim of this project is to investigate the effectiveness of phase-based trauma-focused~     therapy (PBT) and intensive trauma-focused therapy (I-TFT) for adult patients with PTSD~     related to childhood abuse.~      We will carry out a RCT, randomizing 150 patients to receive either standard TFT, PBT or~     i-TFT. The effects will be assessed at two endpoints of treatment (4, 8 and 16 weeks) and~     after a 6 and 12 months follow-up in an intention-to-treat analysis.~   "
28488|NCT03194100|"~     The investigators measured serum METRNL levels in newly diagnosed patients with type 2~     diabetes (T2DM) compared with normal glucose tolerance or prediabetes and explored the~     correlations between its serum levels and various metabolic parameters~   "
28489|NCT03194087|"~     Results from KDOQI guidelines, parathyroid hormone (PTH) level within target range is~     150-300pg/ml. Both lower PTH levels and higher PTH levels were associated with higher risk of~     all-cause mortality. However, in out of target range, it is still unknown which mortality~     higher. so, in this prospective, observational clinical trial study. the investigators will~     observe the mortality and cardiovascular incidence rate between SHPT(>800pg/ml) and low serum~     PTH levels(<60pg/ml). Both two groups of patients will receive a reasonable treatment~     according to the suggestions in K/DOQI guidelines.~   "
28490|NCT03194074|"~     Postoperative cognitive impairment is one of the most common complications in elderly~     surgical patients. Laser laryngeal surgery is a short procedure, but characterized by high~     risk of disastrous airway fire. So the recommended oxygen concentration is less than 30%. For~     elderly patients, because of preoperatively declined cardiovascular and lung function and~     cognitive function, there is a potential that intraoperative low oxygen concentration may~     lead to drop of arterial oxygen tension, decrease of brain oxygenation, and exacerbate brain~     function impairment. Intravenous anesthesia and inhalation anesthesia is two commonly used~     technique for general anesthesia. Consequently, we carry out this study to identify whether~     different classes of anesthetics can affect postoperative cognitive function in old patient~     undergoing laser laryngeal surgery.~   "
28491|NCT03194061|"~     The aim of this study is to evaluate the feasibility of hypofractionated radiation therapy~     and concomitant chemotherapy with cisplatin for locally advanced head and neck cancer in a~     high volume brazilian center.~   "
28492|NCT03194048|"~     This study examined the effect of Functional Chewing Training(FuCT) on tongue thrust and~     drooling in children with cerebral palsy.~   "
28493|NCT03194035|"~     The aim of this study is to study the per and post-exertional variations of the pro and anti~     inflammatory markers during an ultra-endurance race in healthy volunteers.~   "
28494|NCT03194022|"~     The aim is to study per and post-exertion variations of biological markers during an~     ultra-endurance race~   "
28495|NCT03194009|"~     The PRuDENTE study proposes to assess if metformin therapy a viable, efficient and~     cost-effective intervention to decrease the incidence of type 2 diabetes (DMT2) in adult~     subjects with obesity and pre-diabetes in Mexico City. Half of the individuals recruited will~     receive as intervention, metformin and lifestyle modification therapy and the other half will~     receive only lifestyle modification therapy.~   "
28497|NCT03193983|"~     Fingertip is a complex structure that is responsible for the fine function of the fingers and~     the whole hand. A fingertip injury is any soft tissue, nail or bony injury distal to the~     insertions of the long flexor and extensor tendons of a finger .Fingertip injury is a serious~     condition that if untreated properly could lead to significant functional disability and~     disuse of the injured finger. Up to date, defining the best treatment option for this injury~     remains controversial. Hand surgeons are divided between proponents of flap coverage and~     conservative treatment, driven by beliefs, training programs and financial aspects. After~     recently reviewing the literature for the current best evidence and fundamentals of~     conservative treatment, Krauss and Lalandei in their recent review of the literature, pointed~     out to the necessity for implementing controlled trials to compare both ways of treatment.~   "
28498|NCT03193970|"~     The intent of this study is to establish a registry of post‐surgical outcomes in patients~     undergoing radical cystectomy at MD Anderson Cancer Center and the collaborating~     institutions. The goals of this initiative are to obtain a detailed baseline of multiple~     patient‐reported outcomes (PRO) and clinician‐reported outcomes (CRO) as well as various~     presenting conditions associated with them, so that future quality improvement interventions~     can be evaluated accurately as to their relative contribution to improved outcomes.~   "
28499|NCT03193957|"~     A study comparing the usability of the Autoinjector and Pre-filled Syringe of SB4 in Subjects~     with Rheumatoid Arthritis.~   "
28500|NCT03193944|"~     General objective: To assess the effect of vitamin D supplementation on metabolic syndrome~     among food insecure and vitamin D deficient older adults in Karaj city, Alborz province in~     Iran. A two-arm randomised controlled trial (RCT) will be conducted by recruiting~     participants. Inclusion Criteria: Food insecure, metabolic syndrome; Vitamin D deficiency~     Exclusion Criteria: those who are already taking any type of vitamin D supplements,~     Individuals with a history of allergy, Those subjects with serious medical condition such as~     cancer, heart attack, stroke, and etc., Intervention group: The intervention will start from~     10 of May 2017 to 11 of July 2017 for 2 months. The intervention group will receive 50,000 U~     vitamin D3 per week (equivalent to 1,250 μg) for 8 weeks plus pamphlets and brochures about~     nutrition and health at the beginning of the study. Control group: The respondents in control~     group will receive placebo plus brochures and pamphlets related to nutrition and health at~     the beginning of the study. The data collection process will identify the older adults for~     both groups; intervention and control. Consent will be obtained from those who are eligible.~     Anthropometric measurement (height, weight, body mass index, and waist circumference), blood~     pressure measurement, blood taking and three-day food record will be obtained during baseline~     from all study respondents in the intervention and control groups. Primary Output: Achieving~     25 (OH) D upper than insufficient serum 25(OH) D level >30 ng/l. Secondary Output: Reduction~     anthropometry (body mass index (BMI) and waist circumference (WC), Improved Biomarkers~     indicators (lipid profile, fasting blood fast), improved blood pressure before and after~     intervention.~   "
28501|NCT03193931|"~     The study is designed as an open-label, randomized, prospective, multicenter, phase II study~     comparing pembrolizumab with methotrexate in elderly, frail or cisplatin-ineligible patients~     with squamous carcinoma of the head and neck (HNSCC)~   "
28502|NCT03193918|"~     This is a single-arm phase I/Ib study of crenolanib combined with ramucirumab/paclitaxel as~     second line therapy for patients with advanced/metastatic adenocarcinoma of the esophagus,~     GEJ or stomach. Patients will be enrolled in two phases; dose escalation phase and dose~     expansion phase.~   "
28503|NCT03193905|"~     Background~      Major spinal surgery tend to be lengthy with an increased risk of hypothermia. A quality~     improvement project of patients undergoing major spinal surgery showed that 67 % were~     hypothermic at the beginning of surgery. Several patients expressed a feeling of coldness at~     the arrival of the operating theatre.~      Aim~      To evaluate if Bairhuggers Full Access Underbody blanket can prevent hypothermia at~     initiation if used as prewarming and intraoperative warming compared to the results from the~     local quality improvement project. In addition we aim to explore patients´ experiences of~     comfort in relation to their temperature.~      Method~      Temperature of patients undergoing major spinal surgery (n=30) will be assessed at arrival to~     the theatre, after insertion of bladder catheter, at the start and end of surgery using a~     bladder temperature. The patients´ experiences of comfort will be evaluated with a 5 point~     Likert at the arrival to the operating theatre and after ten minutes of active prewarming~     with Bairhuggers Full Access Underbody blanket. Preoperatively ten randomly chosen patients~     will be observed and later interviewed in order to obtain further information regarding their~     experiences of comfort in relation to their temperature.~      Conclusion and perspectives~      By increasing the investigators knowledge on Bairhuggers Full Access Underbody blanket and~     its effects in preventing hypothermia as well as gaining insight to patients´ experiences of~     comfort in relation to temperature, the investigators anticipate to improve pre-anesthetic~     care and minimize risk factors associated with hypothermia for patients undergoing major~     spinal surgery.~   "
28504|NCT03193892|"~     Pulmonary lymphangioleiomyomatosis (LAM), a disease characterized by diffuse cystic changes~     in the lung, is a rare disorder that affects almost exclusively women. The main objectives of~     this study are to accurately evaluate the prevalence of LAM, the status of disease, the~     diagnosis and treatment, the quality of care, and the health related outcomes in China.~   "
28505|NCT03193879|"~     Particulate matter(PM) exposure has been shown to increase the morbidity and mobility of a~     variety of respiratory diseases, including COPD and asthma. This study focus on the effects~     of PM on the pulmonary function and acute exacerbation of COPD and asthma patients in China,~     where PM exposure is much heavier than the United States and European countries.~   "
28506|NCT03193866|"~     The overarching goal of this study is to determine whether rituximab (RTX) offers~     effectiveness and safety advantages over other commonly used approved Disease-Modifying Drugs~     (DMT) in the largest real-world population-based structured prospective follow-up cohort of~     Relapsing-Remitting Multiple Sclerosis (RRMS) patients. The study will include both treatment~     naïve patients starting their first DMT and patients switching from a previous first line DMT~     (escalation/second-line).~   "
28507|NCT03193853|"~     This study evaluates efficacy of TAK- 228 and TAK- 117 followed by cisplatin and nab~     paclitaxel in patients with metastatic triple negative breast cancer.~   "
28509|NCT03193827|"~     The aim of this study is to demonstrate the efficacy of in-line filtration in reducing the~     incidence of postoperative phlebitis associated with peripheral short-term vascular access.~      In this controlled trial, 268 surgical patients are 1:1 randomised to in-line filtration~     (study group) and standard care (control group). The incidence of phlebitis (defined as~     Visual Infusion Phlebitis, VIP score≥2) within 48hrs postoperatively is compared between the~     two groups, as well as the onset and severity of phlebitis and the reasons for removal of the~     cannula. The lifespan of venous cannulae and cost-of-care are compared for the study and~     control groups through a Kaplan-Meier curve. Multivariate Cox regression analysis is~     performed to evaluate the effect of in-line filtration on risk of phlebitis and cannula~     removal.~   "
28510|NCT03193814|"~     The purpose of this study is to evaluate the efficacy and safety of apatinib in combination~     with second-line FOLFOX or FOLFIRI for metastatic colorectal cancer in patients with disease~     progression during or after first-line therapy.~   "
28511|NCT03193801|"~     To assess the safety and effectiveness of the SAPIEN 3 (Edwards Lifesciences, Irvine,~     California) transcatheter heart valve in patients with a failing mitral bioprosthetic valve.~   "
28512|NCT03193788|"~     This study aims to verify superiority of pemetrexed maintenance to observation for patient~     without disease progression after 1 st line cisplatin-based chemotherapy.~   "
28513|NCT03193775|"~     -  HBV is not curable with persistent HBsAg even after the disappearance of HBV DNA.~        -  HBsAg > 1000 IU/ml is associated with the risk of virological recurrence and HCC.~        -  There is an impaired immune response to HBsAg and HBV vaccine is an easily available,~          cost-effective, non-harmful method of stimulating immunity.~   "
28514|NCT03193762|"~     Today, there is no simple tool for measuring patient anxiety. The primary purpose of this~     study is to evaluate the ability of the Visual Analogue Scale (VAS) to measure anxiety in~     painful hospitalized patients, and to correlate it to STAI-Ya and HAD-7A auto questionnaires.~   "
28515|NCT03193749|"~     Purpose:~      The ATTACH trial, as currently designed, will primarily test whether a treatment with~     Amiodarone for at least 6 months has a trypanocidal effect among individuals with~     mild-to-moderate Chronic Chagas Cardiomyopathy. A secondary goal will be to confirm, in this~     population, a clinical benefit from this treatment (in terms of reducing mortality or cardiac~     arrhythmic events), and to explore whether a potential trypanocidal effect is associated with~     a clinical benefit.~   "
28516|NCT03193736|"~     The study will evaluate the efficacy and safety of the implant and IOP lowering effects with~     or without glaucoma medications. The procedure will be a stand-alone surgery. Overall, the~     patient will be asked to perform several examinations up to 24 months after surgery.~      The primary efficacy objective of the present study is to show the IOP reduction under~     medication 6 months after surgery compared to medicated diurnal IOP at screening.~   "
28517|NCT03193723|"~     The aim of this study is to evaluate success, efficacy, feasibility and safety of a simple~     five step ultrasound guided local anesthetic infiltration technique for unilateral open~     inguinal hernia repair and to determine the non-inferiority of the block to spinal anesthesia~     by comparing intraoperative and postoperative complications, pain control and patient and~     surgeon satisfaction of the block with spinal anesthesia.~   "
28518|NCT03193710|"~     The body immunity is important to the development of tumor. The immune system is in charge of~     monitoring and cleaning tumor cells in circulation. Anesthesia may alter the immune response~     and affect the elimination of tumor cells. The purpose of the trial is to test whether~     inhalational anesthetic is relevant to tumor metastasis and recurrence of patients undergoing~     colorectal cancer resection through depression of lymphocytes-mediated immunity.~   "
28519|NCT03193697|"~     This trial explores the application of different hip replacement materials in elderly~     patients with unstable intertrochanteric fracture, and aims to provide the experience and~     basis for hip arthroplasty in elderly osteoporosis patients with unstable intertrochanteric~     fracture.~   "
28520|NCT03193684|"~     the aim of this study is to examine the role of autonomic nervous system in the increase in~     hepatic glucose production in response to glucosuria caused by inhibition of renal glucose~     uptake~   "
28521|NCT03193671|"~     This study evaluates the biomarkers CA125 and HE4 and the algorithms RMI and ROMA on a normal~     population in the western region of Sweden. The aim is to improve diagnosis of ovarian~     cancer.~      If the investigators observe a clear improvement in the early diagnosis of EOC, the~     investigators aim to implement the best strategy for all patients with suspected pelvic tumor~     mass in the western region of Sweden.~   "
28522|NCT03193658|"~     The study aims to evaluate the effect of US guided bilateral Thoracolumbar Interfascial plane~     (TLIP) block performed at the level of the lumbar spine surgery (involving 1 up to 3 adjacent~     lumbar vertebrae) after induction of general anesthesia and before starting the surgery on~     postoperative opioid consumption by the patients during the first 24 hours postoperative.~   "
28523|NCT03193645|"~     The DUO study's main objective is to evaluate, in the real life, the prevalence of~     cardiovascular risk in patients with prostate cancer that hormone treatment of androgen~     suppression by Degarelix was introduced.~      This study will also assess, at the initiation of therapy, the prevalence of osteoporosis,~     metabolic comorbidities, depression, sexual and geriatric patients suffering from prostate~     cancer.~   "
28524|NCT03193632|"~     The study aims to correlate Lean Body Mass (LBM) Evaluated by Musculoskeletal Ultrasound with~     Resting Energy Expenditure (REE) measured by Indirect Calorimetry and to generate a~     predictive equation of REE based on LBM, in addition to identifying other factors that may~     affect REE such as age, gender, and severity scores.~   "
28525|NCT03193619|"~     The objective of this study is to assess the clinical use of the Bard® UltraScore™ Focused~     Force PTA balloon in a heterogeneous patient population in a real world, on-label clinical~     application.~   "
28537|NCT03193463|"~     The purpose of this study is to determine if treatment with topotecan by an alternative~     method, direct delivery into brain tumors, is safe and well tolerated. The Cleveland~     Multiport Catheter is a new, investigational device that will be used to deliver topotecan~     into your brain tumor. A second purpose of this study is to determine whether the Cleveland~     Multiport Catheter can be used effectively and safely to deliver topotecan into your brain~     tumor.~      This study will also determine the best dose of topotecan to deliver to your tumor with use~     of the Cleveland Multiport Catheter and will also examine how your tumor responds to~     treatment with topotecan.~   "
28526|NCT03193606|"~     eligible teeth will be randomly divided into two groups to be treated with incomplete caries~     excavation (A), where (A1) represents teeth to be treated with application of Nano silver~     fluoride solution on remaining carious dentin prior to final permanent glass ionomer~     restoration application, (A2) represents comparator group to be restored without Nano silver~     fluoride application prior to restoration. Every participant will receive both the~     intervention and control treatment. Image of radiographic density of remaining carious dentin~     will be evaluated using PSP plate at baseline immediately after restoration and after 6~     months after restorative procedures.~      The null hypothesis tested is that application of Nano silver fluoride solution prior to~     glass ionomer restoration will not increase radiopacity of the underlying dentin treated by~     incomplete carious removal technique compared to that of direct glass ionomer restoration~     without prior application of Nano silver fluoride.~   "
28527|NCT03193593|"~     To determine the safety and efficacy of single intra-operative treatment of EB-001 IM~     injections into the Pectoralis Major (PM) in subjects undergoing breast augmentation with~     subpectoral implants~   "
28528|NCT03193580|"~     Non-invasive brain stimulation can both study and potentially treat neurological disorders.~     Transcranial direct-current stimulation (tDCS) is an emerging safe and tolerability form of~     stimulation and has been used increasingly over the last decade.~      The purpose of this research is to see if two different types of tDCS can improve motor~     function in healthy children. tDCS has been shown to safely enhance hand motor function in~     healthy adults, and those that have suffered stroke and other conditions. Recently the~     investigators demonstrated that tDCS may enhance hand motor function in healthy children,~     however, how it does so is unknown. In addition to assessing changes in motor function when~     tDCS is given during motor skill training, the investigators will perform various tests~     before and after stimulation to understand the changes that happen in the brain accompanying~     motor skill learning and brain stimulation.~      The investigators hypothesize that there will be an accelerated acquisition of motor skill,~     when training is paired with conventional anodal tDCS, HD-tDCS, or sham tDCS.~   "
28529|NCT03193567|"~     The purpose of this study to preliminarily evaluate the safety and efficacy of High Efficient~     Killing Cell Therapy for refractory and advanced non-small cell lung cancer~   "
28530|NCT03193554|"~     Pre-eclampsia is a disorder of pregnancy characterized by hypertension (defined as systolic~     blood pressure 140mmHg or diastolic blood pressure ⩾90 mmHg) and proteinuria (300 mg or~     greater in a 24 h urine specimen and/or protein to creatinine ratio of > 0.30) . The disorder~     usually occurs after 20 weeks of pregnancy and worsens over time. Risk factors for~     pre-eclampsia include: obesity, prior hypertension, older age, and diabetes mellitus,~     primigravida and pregnant women with multiple gestation .~      Healthy women pregnancy can be associated with resistance to the action of insulin on glucose~     uptake and utilization. Insulin Resistance (IR) is defined as decreased ability of target~     tissues such as liver, adipose tissue and muscle to respond to normal circulating~     concentrations of insulin. Insulin Resistance can be a result of a number of factors such as~     defective molecular structure of insulin, defective receptor functioning or defective signal~     transduction pathway .~      Preeclampsia is associated with increased expression of Tumor necrosis Factor α and other~     inflammatory marker which causes Insulin Resistance. Increased Insulin Resistance leads to~     dyslipidemia that can worsen the placental ischemia leading to vicious cycle of~     ischemia-inflammation-Insulin Resistance-dyslipidemia-ischemia . Insulin resistance has also~     been hypothesized to contribute to the pathophysiology of preeclampsia. Compared to women who~     have normotensive pregnancies, women who develop preeclampsia are more insulin resistant~     prior to pregnancy .~      The recognition that specific miRNAs are induced by hypoxia and are commonly dysregulated in~     preeclampsia raises the possibility that such miRNAs mediate the adverse effects of placental~     hypoxia in preeclampsia. MiRNAs present in maternal blood may have the potential to be used~     as biomarkers, as they are relatively stable and tissue specific . It was found that mir-210~     is induced in patients with pre-eclampsia, whether mir-210 contributes to the pathogenesis of~     pre-eclampsia, a complex disorder widely believed to be associated with placental hypoxia .~   "
28531|NCT03193541|"~     To improve upon the non-invasive detection of BCa by further validating a multiplex ELISA~     assay directed at a BCa-associated diagnostic signature in voided urine samples of patients~     with microscopic hematuria.~   "
28532|NCT03193528|"~     To improve upon the non-invasive detection of BCa by further validating a multiplex ELISA~     assay directed at a BCa-associated diagnostic signature in voided urine samples of patients~     with gross hematuria.~   "
28533|NCT03193515|"~     Voided urinary cytology (VUC) is the most widely used urine-based assay for detecting bladder~     cancer (BCa); however, it fails to detect approximately 50% of low-grade or early stage BCa~     when it is most curable. Furthermore, the detection rate of VUC for recurrent BCa is not much~     better. Because of this severe limitation, all patients who are under surveillance to monitor~     for recurrent BCa must undergo an invasive examination of the urinary bladder, where a~     miniature camera is inserted into the bladder and the bladder inspected (cystoscopy). We~     propose to improve the non-invasive detection of recurrent BCa by further validating a~     multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine~     samples.~   "
28534|NCT03193502|"~     -Rivaroxaban is factor Xa inhibitor~   "
28535|NCT03193489|"~     Individualization of exercise is recommended but rarely performed in patients with~     Parkinson's disease (PD).~      Unusually High Intensity and Individual Sensor Motor with Visuomotor Mobility Trainer The~     clinical symptoms, mobility and posture of PD patients. After 3 weeks of intensive treatment,~     treated patients and the control group were subjected to a two-year observation.~      Objectives: The effect of the unusually highly intense and strictly individualized sensomotor~     and visuomotor agility program was determined for the clinical symptoms, mobility and~     stability of non-demented PD patients with a two-year follow-up. Detection and comparison of~     results of patients undergoing biphasic maintenance with the results of intensively treated~     patients and the control group.~      Patients were recalled every 3 months after the first intensive examination and one year~     after a one-year control. The results of the active group were continuously compared with the~     results of the passive and control groups, thus determining the effectiveness of our~     treatment and the deterioration of the other groups in life-quality.~      The treated groups will be divided into two. One Parkinson's group takes part in a treadmill~     treatment that takes place 3 times a week for 2 years. The other group does not undergo a~     special series of exercises after 3 weeks of intensive therapy.~      Main outcome measures: Movement disorder Society Unified Parkinson Disease Rating Scale,~     Motor Experiences of Daily Living, a measure sensitive to changes in a broad spectrum of PD~     symptoms.~      In group time, repeated measurements of variance analysis were compared to MDS-UPDRS M-EDL,~     Beck Depression Score, PDQ-39, EQ5D VAS, Schwab & England Scale for Parkinson's Disease. The~     TUG test and 12 static posturographic measurements are compared and compared to the healthy~     group as a standard.~      An at-limit and individualized sensorimotor and visuomotor agility exercise program vs.~     standard care, will improve non-demeted, stage 2-3 PD patient's clinical symptoms, mobility,~     and postural stability by functionally meaningful margins. As a long-term solution, a~     follow-up treatment can slow down the progression of clinical symtoms.~   "
28536|NCT03193476|"~     This is an international, multicentre, prospective, non-interventional, observational~     registry of patients with X-linked hypophosphatemia (XLH). The main objective of the registry~     is to collect data to characterise the treatment, progression and long-term outcomes of XLH~     in both adult and paediatric settings.~   "
28563|NCT03193125|"~     This double-blind, placebo-controlled randomized trial will assess whether 14 days of oral~     carnitine supplementation modifies mitochondrial fatty acid processing in healthy young~     adults.~   "
28538|NCT03193450|"~     It was suggested that the patient compliance plans an important role in the Hp eradication.~     However, data on whether re-education could improve the eradication rate are lacking. We~     consider that re-education on patients by telephone during the process of drug administration~     could increase the eradication rate in Hp infected patients.~      We hypothesized that telephone re-education during the whole process of drug administration~     would improve the compliance of patients and ultimately increase the Hp eradication rate.~   "
28539|NCT03193437|"~     The purpose of this study is to evaluate the safety, tolerability and effectiveness of~     selinexor in patients with advanced thymic epithelial tumor progressing after primary~     chemotherapy. This is a multicenter, open label phase II trial that uses a Simons two stage~     design. The study population is adults with histologically confirmed, advanced, inoperable~     TETs who are progressing after treatment with at least one platinum containing chemotherapy~     regimen.~      This study is comprised of 2 similar phase II trials, one running in US (25 patients) and one~     running in EU (25 patients):~      There are two study arms:~      Arm A: Thymoma~        -  Stage 1: 15 patients~        -  Stage 2: 10 patients~      Arm B: Thymic carcinoma~        -  Stage 1: 15 patients~        -  Stage 2: 10 patients~   "
28540|NCT03193424|"~     Esophageal cancer is a common malignant tumor in china, occupies the second place of~     malignant tumor morbidity and mortality, the overall 5-year survival rate less than 20%.~   "
28541|NCT03193411|"~     this is an interventional prospective clinical study which was conducted to evaluate the~     efficacy, safety, predictability, ocular aberrations, and flap thickness predictability of~     Visumax femtosecond laser (FSL) compared to Moria M2 microkeratome (MK) in mild to moderate~     myopia.~   "
28542|NCT03193398|"~     This study will determine the efficacy, safety, and tolerability of a once-daily (QD) dose of~     up to 80 mg of BTRX-246040 for 8 weeks in participants with MDD.~   "
28543|NCT03193385|"~     Closed reduction is where the thigh bone is placed into the socket without any surgical~     incision being made. This is more likely to be performed in a child under the age of four~     year. The femoral head is gently manipulated into the socket, whilst the child is under~     anaesthetic. Once the femoral head is in place, a hip Spica is applied and can remain in~     place for up to three months to maintain the hip in the correct position. This allows time~     for healing and for the socket and the thigh bone to mould together as a joint.~      The purpose of this study was to identify and evaluate risk factors of avascular necrosis~     (AVN) after closed treatment for developmental dysplasia of the hip (DDH).~      assessed according to Salter's classification system.~   "
28544|NCT03193372|"~     To survey rosacea patients about their concerns, treatment satisfaction, and quality of life~     associated with their Finacea Foam treatment~   "
28545|NCT03193359|"~     This study is an open-label extension study to evaluate the safety, tolerability and efficacy~     of BOTOX® as headache prophylaxis in Chinese patients with chronic migraine who have~     successfully completed the double-blind study: 1313-301-008.~   "
28546|NCT03193346|"~     This study will evaluate the efficacy and safety of BOTOX® (Botulinum Toxin Type A) compared~     with placebo as headache prophylaxis in Chinese participants with chronic migraine.~   "
28547|NCT03193333|"~     Objectives: To evaluate the non-inferiority in the intraocular pressure decrease of the~     preservative-free ophthalmic solution PRO-122, manufactured by Laboratorios Sophia S.A. de~     C.V., versus concomitant therapy in subjects with uncontrolled primary open-angle glaucoma~     and/or IOP.~      Hypothesis: The mean (average) value of the IOP final absolute reduction in the experimental~     group (PRO-122) is not lower, considering a lower limit of 1 mmHg, compared to the IOP mean~     absolute reduction of the standard group (concomitant therapy).~      Methodology: A non-inferiority, phase III, double-blind, randomized, controlled, parallel,~     clinical trial~   "
28548|NCT03193320|"~     This is a single-center prospective randomized control trial (RCT) to determine whether the~     continuous monitoring of the plethysmographic variability index (PVI) during low-risk~     surgeries, can be used to optimize the intraoperative fluid administration. Low-risk patients~     that attend our day surgery unit, and who will be operated under general anesthesia, will be~     randomized to either a liberal fluid group, a restrictive fluid group or a dynamic monitoring~     group (PVI-directed). The amount of fluid infused together with the time to discharge, will~     be assessed in each participant during the postoperative period along with additional~     secondary outcomes.~   "
28549|NCT03193307|"~     The primary objective of this trial is to investigate the effect of multiple doses of~     ethinylestradiol / levonorgestrel (Microgynon®) on single dose pharmacokinetics of BI 409306~     and the effect of single dose of BI 409306 on multiple dose pharmacokinetics of~     ethinylestradiol / levonorgestrel (Microgynon®)~   "
28550|NCT03193294|"~     Angina is form of chest pain that is due to a lack of blood to the heart muscle. Angina is~     commonly triggered by stress and exertion, and is a common health problem worldwide. The~     diagnosis and treatment of angina is usually focused on detection of blockages in heart~     arteries, and relief of this problem with drugs, stents or bypass surgery. However, about one~     third of all invasive angiograms that are performed in patients with angina do not reveal any~     blockages. Many of such patients may have symptoms due to narrowings in the very small micro~     vessels (too small to be seen on an angiogram). The purpose of this research is to undertake~     a 'proof-of-concept' clinical trial to gather information as to whether routine tests of~     small vessel function in the heart might help identify patients with a stable coronary~     syndrome due to a disorder of coronary function (vasospastic or microvascular angina), and~     appropriately rule out this problem in patients with normal test results. The diagnostic~     strategy enables stratification of patient sub-groups to optimized therapy (personalised~     medicine). Evidence of patient benefits in this study would support the plan for a larger~     study that would be designed to impact on healthcare costs and patient reported outcome~     measures (PROMS).~   "
28564|NCT03193112|"~     Agomelatine is a melatonin drug used to treat depressive disorder. Agomelatine may also some~     effects on ocular pressures. In this study, we aimed to demonstrate that melatonin decreases~     intraocular pressures when given depressive patients.~   "
28638|NCT03192150|"~     The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy of~     ISV-305 (Dexamethasone in DuraSite® 2) compared to Vehicle in the treatment of inflammation~     and pain associated with cataract surgery.~   "
28551|NCT03193281|"~     Chronic myeloid leukaemia (CML) is due to a chromosomal abnormality in white blood cells~     which results in abnormal multiplication. CML in its earlier, slower growing chronic phase~     (CP) is well controlled by the tyrosine kinase inhibitor (TKI) drug imatinib, which targets~     the consequences of the chromosomal abnormality, inducing a response and subsequent remission~     (as measured using molecular techniques on patient blood or bone marrow samples in the lab).~     Dasatinib, a newer TKI drug, similar in design to imatinib, gives a more rapid molecular~     response, however the long term side-effects are less known than imatinib.~      This study will investigate the efficacy and safety of a treatment plan for patients with~     newly diagnosed CML-CP, where dasatinib will be used to more rapidly induce a molecular~     response (MR3.0) within 12 months, after which imatinib will be used to maintain the CML in~     that remission. It is hypothesised that imatinib is safe and effective in maintaining MR3.0~     in patients with CML who achieve MR3.0 at 12 months following initial induction therapy with~     dasatinib.~   "
28552|NCT03193268|"~     Determine the short-term and lasting effects of intensity-matched exercise programs on level~     2-3 PD patients' clinical symptoms, postural control, and mobility.~      Hypothesis~        1. The inclusion of a Borg-scale/heart-rate matched active control group will allow us to~          test the idea that, in addition to a fitness element, the reflexive movements that~          chellenge PD patients' sensorimotor system will improve patients' clinical symptoms,~          posture, and mobility more than fitness training and that such lasting effects will be~          superior in the agility compared with the fitness-control group. This hypothesis emered~          from the idea that the favorable results in the currently under review paper may be in~          part due to a simple conditioning effect instead of a specific motor learning effect~          caused by the xbox training.~        2. If feasible, i.e., if there is a lerge enough pool of patients to randomize, a balance~          training group will be also added to test the idea that the reflexive actions evoked by~          the agility program by xbox exergaming still produce superior adaptations vs. the~          balance group because xbox forces patients to rapidly and reflexively execute movements~          (respond to cues, prompts), while balance training allows patients to stop, go, stop,~          and go and disrupt the continous execution of linked movements. The disruptions of~          movement chains could arise from small losses of balance on the unstabel surfaces, need~          for patients to re-initiate every movement element of a sequence, planning each movement~          element. It is not clear yet how it woul be possible to match all three intervention~          groups on Borg/heart rate intensity.~   "
28553|NCT03193255|"~     Multipurpose solutions (MPS) are the most commonly prescribed regimen to clean, disinfect and~     rinse rigid lenses. The preservatives used in MPS may cause hypersensitivity and the presence~     of quaternary ammonium compounds (QAC) may increase development of antiseptic resistance~     mediated by QAC resistance genes, thus lowering the efficacy of disinfection. Povidone-iodine~     (PVI) has been safely used as a disinfectant for ophthalmic operations and eye drops. The~     cleadew GP (Ophtecs, Japan) tested in the current study is a PVI based rigid lens~     disinfecting solutions which does not employ QAC. If its efficacy and safety can be confirmed~     in this study, it will be a good alternative rigid lens care regimen for children.~   "
28554|NCT03193242|"~     This study is an extension of a pilot study in which investigators developed and tested a~     computerized tool to help physicians to determine if their patients' asthma is well~     controlled, advise them on medication changes required according to the current level of~     control, and automatically generate an electronic version of the AAP, all based on patient~     responses to a questionnaire completed by patients on a tablet computer. In this phase~     patients will have the ability to complete the questionnaire on their smartphones, through a~     pre-downloaded app and will have access to an electronic asthma self-management app.~   "
28555|NCT03193229|"~     The overarching objective of our work is to provide an inexpensive and scalable m-health tool~     to increase both volume and intensity of physical activity and reduce sedentary behavior in~     patients at risk for type 2 diabetes. The objective of this study is to pilot test MapTrek, a~     text-messaging based intervention.~   "
28556|NCT03193216|"~     This study evaluates the addition of an alginate based solution to twice daily proton pump~     inhibitor therapy (PPI) in patients undergoing ablative therapy for dysplastic Barrett's~     esophagus. The investigators hypothesize that the addition of this medication will help to~     achieve complete remission of Barrett's over a shorter period of time.~   "
28557|NCT03193203|"~     The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of the~     autoinjector and pre-filled syringe of SB4 in healthy male subjects.~   "
28558|NCT03193190|"~     A Phase Ib/II, open-label, multicenter, randomized study designed to assess the safety,~     tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based~     treatment combinations in participants with metastatic Pancreatic Ductal Adenocarcinoma~     (PDAC).~   "
28559|NCT03193177|"~     Effectiveness of fasting or fasting-mimicking diet has been proved an effective approach to~     treat metabolic and autoimmune diseases in mice. However, clinical trials performing~     prolonged fasting with more than 7 days have not been reported. Investigators conduct an open~     label, phase I/II clinical trial to evaluate the safety and effectiveness of the 21-day~     fasting-like diet in the treatment of metabolic and autoimmune diseases.~   "
28560|NCT03193164|"~     The study will investigate the effects of neuromuscular electrical stimulation (NMES) in~     patients with septic shock. The objective of this study will be investigate the effects of~     neuromuscular electrical stimulation (NMES) in patients with septic shock.~   "
28561|NCT03193151|"~     INTERLIVER is a prospective observational study of the relationship of the molecular~     phenotype of 300 liver transplant biopsies to the histologic phenotype and the clinical~     features and outcomes. A segment of a biopsy performed as standard-of-care for indications,~     or by center protocol, will be used for gene expression study.~   "
28562|NCT03193138|"~     Anti-androgenic therapies relying on peripheral and/or central blockade for the treatment of~     prostate cancer seems to have an impact on the cardio-vascular system. This study~     investigates reports of cardiovascular toxicities for treatment including Anatomical~     Therapeutic Chemical (ATC) classification: sex hormones (G03), hypothalamic hormones (H01C)~     and sex hormones used in treatment of neoplastic diseases (L02) in the French~     pharmacovigilance database and European Clinical Trials (EudraCT) database.~   "
28565|NCT03193099|"~     WIN-HD is a monocentric longitudinal study comparing premanifest Huntingtin (HTT) mutation~     carriers and non HTT mutation carriers to determine that white-matter atrophy occurs far~     earlier than clinical onset in HD using Diffusion-weighted Nuclear Magnetic Resonance (N~     spectroscopy (DWS) and Diffusion Tensor Imaging (DTI).~      The investigators will recruit up to 20 premanifest HTT mutation carriers (15 completed) and~     up to 20 non HTT mutation carriers (15 completed). It is important to have those 2~     populations in order to compare our results and determine if there are significant~     white-matter changes far from the onset of HD. Therefore, non HTT mutation carriers will be~     age and gender matched to premanifest HTT mutation carriers.~      In order to test the hypothesis, the study has 2 visits with a year interval.~      This study is based on 4 principal criteria:~        1. Imaging criteria~        2. Clinical and neurological criteria~        3. Psychological criteria~        4. Behavioral criteria~   "
28566|NCT03193086|"~     The development and progression of multiple sclerosis seem to be driven by concomitant~     inflammation and, to a less well-defined degree, disturbances in metabolism of individual~     cells of the human central nervous system as well as changes in the dynamical supply of blood~     to the brain. These alterations in normal physiology can be quantified by investigating the~     change in specific parameters over the time course of multiple sclerosis evolution. Amongst~     these specific parameters, the ability of the so-called blood-brain-barrier to selectively~     filter nutrients from the blood stream prior to passage into the nervous tissue, is disrupted~     in multiple sclerosis, and the severity of this deficiency seem to be related to the~     underlying disease burden. The present study utilises a novel imaging technology in order to~     monitor changes in the integrity of the blood-brain-barrier over the course of treatment with~     a biological disease modifying agent known as alemtuzumab. Alemtuzumab is a potent~     immunosuppressant drug. It is hypothesised that alemtuzumab reverts the deficiency in~     blood-brain-barrier integrity and, conversely, the severity of blood-brain-barrier disruption~     at several time points during alemtuzumab treatment can be utilised as prognostic marker for~     the requirement of additional administration of alemtuzumab beyond the regular treatment~     regimen. In addition, several other factors are investigated by advanced imaging techniques~     in combination with blood and urine samples in order to elucidate the possible underlying~     mechanism of alemtuzumab efficacy. It is hypothesized that alemtuzumab normalises metabolic~     alterations and changes in the blood supply through resolution of inflammation in the brains~     of multiple sclerosis patients.~   "
28567|NCT03193073|"~     The fibroblast growth factor-23-bone-kidney axis is part of newly discovered biological~     systems linking bone to other organ functions through a complex endocrine network that is~     integrated with the parathormone/vitamin D axis and which plays an equally important role in~     health and disease . Most of the known physiological function of fibroblast growth factor 23~     to regulate mineral metabolism can be accounted for by actions of this hormone on the~     kidney.In a recent experimental study, fibroblast growth factor-23 was shown to cause~     pathological hypertrophy in rat cardiomyocytes by calcineurin-nuclear factor of activated T~     cells and treatment with fibroblast growth factor -blockers reduced left ventricular~     hypertrophy in experimental models of chronic renal failure.The current hypothesis is that,~     in healthy individuals, iron deficiency stimulates increased production of fibroblast growth~     factor23. At the same time, iron is thought to be the cofactor of enzymes taking part in the~     degradation of intact fibroblast growth factor-23 and thought to have a role in the excretion~     of degraded FGF-23 parts .Studies speculated that Angiotensin Converting Enzyme inhibitors~     may exert their anti-proteinuria effects at least in part by reducing serum fibroblast growth~     factor-23 levels although it is difficult from the results of this study to understand which~     comes first and brings about the other; decrease in proteinuria or fibroblast growth~     factor-23. Available evidence points to the deleterious effects of increased fibroblast~     growth factor-23 level in proteinuria, but the precise molecular mechanism still remains to~     be explored. An intricate and close association exists among parathormone, phosphorus, active~     vitamin D with FGF23, but the independent role of the latter on proteinuria is the least~     explored. Elaborately conducted studies that control effects of confounding factors~     adequately are needed to demonstrate the independent pathogenic role of FGF23.~   "
28568|NCT03193060|"~     This study is a multi-centre, prospective observational study. The study plans to enrol 500~     patients with localized or locally advanced prostate cancer who are eligible and intended to~     be prescribed Zoladex® (goserelin acetate implant) 10.8 mg or Zoladex® (goserelin acetate~     implant) 3.6 mg as monotherapy or in combination with androgen blockade (CAB) at 50 clinical~     sites in China. The effectiveness and safety data will be collected at baseline and each~     visit within 26 weeks after treatment of Zoladex®.~   "
28569|NCT03193047|"~     The purpose of this study is to determine if bempedoic acid (ETC-1002) 180mg added to PCSK9~     inhibitor (evolocumab) therapy is effective and safe in patients with elevated LDL~     cholesterol.~   "
28570|NCT03193034|"~     The primary objective is to investigate the change from pre-operative baseline to two year~     postoperative functional performance improvement for the ATTUNE® primary, cementless TKA RP~     system as measured with the KOOS questionnaire (KOOS-ADL sub-score) in the Japanese patient~     population.~   "
28571|NCT03193021|"~     The objective of the trial is to demonstrate the safety and effectiveness of the Cardiva~     Mid-Bore Venous Vascular Closure System (VVCS) in sealing femoral venous access sites and~     providing reduced times to ambulation (TTA) compared with manual compression at the~     completion of catheter-based procedures performed through 6 - 12 Fr introducer sheaths.~   "
28572|NCT03193008|"~     AUS/FNAC allows the identification of tumors without axillary tumor involvement, or with low~     axillary tumor burden, many of which do not benefit from SLNB, in the staging of early breast~     cancer.~      Objective: To calculate the negative predictive value of AUS/FNAC in those patients with~     breast cancer who meet ACOSOG Z0011 criteria.~   "
28573|NCT03192995|"~     This project is a placebo-controlled, double-blind randomized trial evaluating the~     feasibility, tolerability, acceptability and adherence for lorcaserin among actively using,~     men who have sex with men (MSM) with cocaine use disorders.The study will enroll 45~     individuals who will randomly be assigned to either the treatment (lorcaserin) arm or the~     placebo arm, to be taken twice a day for 12 weeks.~   "
28574|NCT03192982|"~     To investigate whether compression therapy with foot pump reduce post-operative edema,~     facilitate wound healing of operation wounds, promote healing of ischemic ulcers and shorten~     hospitalization, increase and improve the patient's subjective quality of life faster~   "
28575|NCT03192969|"~     To investigate the safety and efficacy of abatacept with steroid treatment in comparison to~     steroid treatment alone in up to a 28 week taper of steroid treatment to sustain remission of~     Giant Cell Arteritis in adults.~   "
28602|NCT03192618|"~     To compare The Impact on Recurrence Risk of Adjuvant Transarterial Chemoinfusion (TAI) for~     Patients With Hepatocellular Carcinoma And Microvascular Invasion (MVI) After Hepatectomy.~   "
28576|NCT03192956|"~     Research hypothesis~        -  There is a correlation between the quantity of fluid markers of CNS injury in blood and~          DCS.~        -  There is a correlation between quantity and kind of fluid markers of CNS injury in blood~          and both diving profile and severity of DCS.~        -  There is a correlation between the quantity of inflammatory markers in blood an DCS.~      Objectives:~        -  Assess whether individuals suffering decompression sickness exhibit fluid markers of~          central nervous system injury.~        -  Evaluate the correlation between quantity and kind of fluid marker of CNS injury and~          clinical signs of neurological impairment.~        -  Evaluate the correlation between quantity and kind of fluid marker of CNS injury and~          clinical outcome after 3-6 months.~        -  Assess whether individuals suffering decompression sickness exhibit inflammatory markers~          in blood.~   "
28577|NCT03192943|"~     The purpose of this study is to assess the safety and tolerability for the combination~     therapy of BMS-986205 and Nivolumab in patients with advanced tumors~   "
28578|NCT03192930|"~     Research hypothesis~        -  Prolonged hyperbaric exposure will affect the central nervous system~        -  Prolonged hyperbaric exposure will induce inflammatory changes~        -  Prolonged hyperbaric exposure will affect fluid regulation in the body~      Objectives:~        -  To investigate the presence of cerebrospinal biochemical markers in blood during~          prolonged hyperbaric exposure~        -  To investigate changes in the quantity of cerebrospinal biochemical markers in blood~          during decompression after prolonged hyperbaric exposure~        -  To investigate the presence of inflammatory markers in blood during prolonged hyperbaric~          exposure~        -  To investigate changes in the quantity of inflammatory markers in blood during~          decompression after prolonged hyperbaric exposure~        -  To investigate if prolonged hyperbaric exposure alters fluid balance in the body~   "
28579|NCT03192917|"~     The purpose of this project is to verify the relationship between low intensity shock wave~     treatment (LI-SWT) and increased scores in self-assessment regarding to erectile function~     (ED) and sexual intercourse, in patients, who has undergone a radical prostatectomy (RP). The~     data will be obtained from patients using international accepted sexual questionnaires prior~     to the LI-SWT and 5, 12 and 24 weeks following treatment.~   "
28580|NCT03192904|"~     According to published studies, there are two main approaches in the dissection of~     intersegmental plane: stapling devices and energy instrument separation. However, only a few~     retrospective studies focused on the perioperative outcomes of these two approaches, and~     there has been no definitive conclusion about which method is better. So the investigators~     want to conduct a prospective study, trying to figure out this problem.~   "
28581|NCT03192891|"~     Numerous single-center studies have indicated gadolinium-enhanced stress CMR perfusion~     imaging has excellent diagnostic accuracy for coronary artery disease and negative clinical~     event rates, with its diagnostic accuracy exceeding nuclear scintigraphy. However, current~     prognostic evidence supporting clinical use of stress CMR is limited by study size,~     single-center settings with a predominance of academic centers, and a lack of real-world~     study design. Large-scale multicenter real-world evidence from a registry will provide the~     much needed information to guide evidence-based clinical adaptation that benefits patient~     care.~   "
28582|NCT03192878|"~     Takayasu arteritis (TA) is a chronic inflammatory disease affecting large and medium caliber~     arteries, particularly the aortic arch and its main branches. Clinical manifestations are~     caused by the marked thickening of the wall of the involved vessels, resulting in lumen~     narrowing and ischemia of the tributary districts. Therapy is based on the use of~     corticosteroids, immunosuppressants, and biologic drugs including infliximab, a monoclonal~     antibody blocking tissue necrosis factor (TNF)-alpha. Biosimilar infliximab is commercially~     available and used in the treatment of various immune-mediated conditions. There are~     currently no data on the efficacy and safety of biosimilar infliximab in the treatment of TA.~      The investigators propose this monocentric, observational, prospective, open label study to~     evaluate the efficacy and safety of biosimilar infliximab in the treatment of 30 patients~     with TA. Specifically, the study will include: I) TA patients refractory to treatment with~     corticosteroid and/or immmunosuppressive therapy, not previously treated with infliximab; II)~     TA patients already receiving treatment with originator infliximab.~      Biosimilar infliximab will be administered at dosages usually employed in the treatment of~     TA. Specifically, patients not previously treated with the originator drug will receive~     biosimilar infliximab intravenously at a dose of 5 mg/Kg at time 0, at week 2, at week 4;~     thereafter, treatment will be administered every 4-6 weeks at a dose of 5-10 mg/kg based on~     clinical judgement. In patients previously treated with the originator drug, biosimilar~     infliximab will be administered at the same dosages.~      To evaluate the efficacy of therapy, changes in clinical manifestations, laboratory~     examinations, and imaging findings including angio-magnetic resonance imaging (MRI) of~     thoracic and abdominal vessels and total body PET/CT scan will be evaluate at time 0 as well~     as 6 and 12 months following treatment initiation. In order to evaluate the safety of the~     study treatment, the investigators will stringently evaluate possible side effects of~     treatment, including infusion reactions, changes in laboratory tests, infection, cancer,~     autoimmune manifestations, neurological and cardiovascular symptoms.~      The total duration of follow up for each patient will be 52 weeks from enrolment.~   "
28583|NCT03192865|"~     This study aims to assess consequences and causes of hemidiaphragmatic paralysis for~     ambulatory arthroscopic shoulder surgery in patients with BMI ≥ 30 kg/m².~   "
28584|NCT03192852|"~     We aim to evaluate colorimetric changes after supervised whitening treatment, using Violet~     LED light associated or not with carbamide peroxide 35% gel. 80 will be divided into: Group 1~     - Violet LED light, Group 2 Violet LED light + carbamide peroxide 35% gel, Group 3 -hydrogen~     peroxide 35% and Group 4 will be submitted to the gingivoplasty surgery procedure, for~     aesthetic desire, after whitening treatment with Violet LED light without gel. The~     colorimetric changes will be measured before, right after each whitening session in the end~     of the period of 3 months, through the Vitapan Classical (Vita) color scale, and by digital~     spectrophotometer. The sensibility degree will be measured by the Visual Analogue Scale (VAS)~     . The gum tissues Group 4, will be analyzed by histomorphometrically. Quality of life will be~     evaluated.~   "
28585|NCT03192839|"~     This clinical trial will evaluate the effects of giving supplements of PUFA to premature~     infants.~   "
28586|NCT03192826|"~     To compare the efficacy of a Brinzolamide/Brimonidine fixed combination (FC) with Brimonidine~     0.2% in preventing intraocular pressure (IOP) elevations after neodymium:~     yttrium-aluminum-garnet (Nd:YAG) laser posterior capsulotomy.~   "
28587|NCT03192813|"~     Current care randomized clinical trial comparing the CE marked Symetis ACURATE neo™ Aortic~     Bioprosthesis and ACURATE TF™ Transfemoral Delivery System with the CE marked Medtronic~     CoreValve Evolut R TAVI system (or any future CE-marked CoreValve versions).~   "
28603|NCT03192605|"~     The objective of the study is to determine how wild blueberry consumption affects glucose~     regulation, gastrointestinal hormones and satiety in healthy adults.~   "
28604|NCT03192592|"~     Safety and effectiveness evaluation of a new moisturizer formulation with antioxidant,~     anti-inflammatory and anti-microbial effects in the prevention of diabetics dry skin and~     complications.~   "
28588|NCT03192800|"~     Spinal dural arteriovenous fistulas (SDAVFs) are the most common vascular disorder of the~     spine and account for approximately 70% of spinal vascular malformation.They are a rare~     pathology with an excepted incidence of only 5-10 new cases per million inhabitants per year.~     Most fistulas are found in the thoracolumbar region and > 80% of all SDAVFs are located~     between T6 and L2, whereas the cranio-cervical, cervical and sacral fistulas are more rare.~     SDAVFs have an overwhelmingly male predominance (80%), with an age presentation in the fifth~     or sixth dacede. It is presumed that SDAVFs are acquired diseases. A typical SDAVF is located~     inside the dural mater close to nerve root. It is fed by a radiculomeningeal artery and~     enters a radicular vein that merges in the perimedullary plexus. The presence of a shunt~     leads to a reversal of blood flow to the spinal cord venous system, which then induces venous~     hypertensive myelopathy.~   "
28589|NCT03192787|"~     The purpose of this study is get to know what and how Sanwujiaowan capsule in hospital~     results in drug-induced liver injury or adverse drug reactions from a cohort event monitoring~     as registration research.~   "
28590|NCT03192774|"~     A single center registry including all patients treated with TAVI at the Heart Center, Bad~     Segeberg, Germany~   "
28591|NCT03192761|"~     The investigators wish to compare 3 methods for reconstruction of the anterior cruciate~     ligament using 3 different grafts: bone-patella tendon-bone, hamstrings and iliotibial tract~     graft, as these methods influence the muscles around the knee differently. Methods using~     bone-patella tendon-bone and hamstrings are performed as standard operations, and the use of~     the iliotibial tract graft using a new method of reconstruction.~      The purpose is:~        1. To assess whether one of three different grafts used for reconstruction of the ACL shows~          superior results compared to the others in relation to mechanical stability and~          re-rupture rates.~        2. To assess whether one of three different methods for reconstruction of the ACL shows~          superior results compared to the others in subjective patient outcome measures.~        3. To assess whether one of three different methods for reconstruction of the ACL shows~          superior results compared to the others when considering specific symptoms and~          complications that can be related to donor-site morbidity.~        4. To assess whether one of three different methods for reconstruction of the ACL shows~          superior results compared to the others when considering muscular power, muscle~          coordination, and function.~   "
28592|NCT03192748|"~     The purpose of this study is get to know what and how Runzaozhiyang capsule in hospital~     results in drug-induced liver injury or adverse drug reactions from a cohort event monitoring~     as registration research.~   "
28593|NCT03192735|"~     We star a multicentre, one-armed, clinical pilot trial intends to investigate the safety and~     effectiveness of Apatinib Combined With Oxaliplatin, Gimeracil and Oteracil Porassium~     Capsules Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer(cT2-4/N+M0)~   "
28594|NCT03192722|"~     The effect of tinted filters and illumination on the visual performance of patients with low~     vision (i.e., individuals with reduced vision that is uncorrectable with glasses, surgery or~     treatments) has been a topic of research and discussion for many years, yet there is no~     current consensus or practice standard for the evaluation and recommendation of colored~     filters and/or illumination intensity. Anecdotally, there have been many subjective reports~     of improvement in visual function and comfort with the use of tinted lenses. Previous studies~     have attempted to elucidate the subjective improvements observed using vision tests, such as~     visual acuity and contrast sensitivity, and the findings have been inconsistent.~     Traditionally, filters and optimal illumination are prescribed clinically through a trial and~     error method, which involves trying various filters and lamps haphazardly to determine which~     if any are preferred by the patient. The investigators are proposing to evaluate whether the~     illumination and filters chosen in office by participants using a new assessment tool the~     LuxIQ/2 translate to overall patient comfort and improved speed, accuracy and print size~     while reading, and to evaluate whether participants have the same illumination and colored~     filter preference determined by the LuxIQ/2 in a clinical office setting and in their home~     environment.~   "
28595|NCT03192709|"~     Adequate growth of the endometrium is crucial for implantation. Accordingly, the pregnancy~     success rate of patients with a thin endometrium is low. Furthermore, there is a little~     information about the factors responsible for impaired endometrial growth in patients with a~     thin endometrium. The researches have revealed that nitric oxide (NO) release can cause~     relaxation of vascular smooth muscle through a cyclic guanyl monophosphate (cGMP)-mediated~     pathway. Sildenafil is a type 5-specific Phosphodiesterase inhibitor that augments the~     vasodilatory effects of NO on vascular smooth muscle by preventing the degradation of cGMP~     and could improve blood flow and endometrial thickness. This study is designed to evaluate~     the effect of vaginally administered sildenafil suppositories on IVF/ICSI outcome of~     infertile patients with repeated IVF/ICSI failures.~   "
28596|NCT03192696|"~     A prospective, non-randomized, international, multi-center study to evaluate the safety and~     effectiveness of the Pantheris OCT-Imaging System to perform atherectomy in In-Stent~     Restenotic (ISR) lesions in lower extremity arteries.~   "
28597|NCT03192683|"~     Examining custom made sling vs. off the shelf sling for immobilization following pediatric~     upper extremity fractures.~   "
28598|NCT03192670|"~     The primary objective of this study is to confirm and compare the effect of methods of~     Low-level light therapy (LED-T) in the mild cognitive impairment.~   "
28599|NCT03192657|"~     This is a 52-week, randomized, open and routine treatment controlled study. This study will~     assess the safety and efficacy of basiliximab as an add-on treatment for interstitial~     pneumonia in clinical amyopathic dermatomyositis (CADM) patients. 100 CADM patients are~     planned to be enrolled in a single center.~   "
28600|NCT03192644|"~     To compare the impact on recurrence risk of adjuvant TAI and adjuvant TACE for patients with~     HCC and PVTT after hepatectomy.~   "
28601|NCT03192631|"~     There is a lack of incentive approach for patients who suffer from schizophrenia yet lack the~     insight to accept treatment. Most existing approaches involve coercion and involuntary~     hospitalizations. This study will explore whether patients with poor insight and lacking in~     competence for treatment decisions will improve their acceptance and adherence of depot~     injection antipsychotic medication if a financial incentive is offered. Ethical~     considerations are also explored for this innovative pilot study~   "
28609|NCT03192527|"~     KN015,the active substance recombinant human Follicle Stimulating Hormone（FSH） Fc fusion~     protein, which belongs to the pharmaceutical class gonadotropins.KN015 is proposed for~     Assisted Reproductive Technology (ART) programs only. Its indication is Controlled Ovarian~     Stimulation （COS）in combination with a gonadotropin releasing hormone (GnRH) antagonist for~     the development of multiple follicles in women participating in an ART program. Due to its~     prolonged duration of FSH activity compared to conventional recombinant FSH (rFSH), a single~     subcutaneous injection of the recommended dose of KN015 may replace any daily rFSH~     preparation in a COS treatment cycle. This study is to evaluation of the safety,~     tolerability, pharmacokinetics and pharmacodynamics of KN015 in healthy Chinese female~     subjects.~   "
28610|NCT03192514|"~     This study is a cluster randomized control trial aimed to measure the effectiveness of an~     educational knowledge transfer intervention to prescribers on the discontinuation of two~     targeted classes: Benzodiazepines andNon-benzodiazepine hypnotics.~   "
28611|NCT03192501|"~     This study prospectively evaluates whether the use of iCAGES (integrated CAncer GEnome Score)~     tool in guiding the treatment of advanced cancers is superior to current standard care in~     progress free survival (PFS),overall survival (OS),and improvement of life quality.~   "
28612|NCT03192488|"~     This study seeks to determine whether a simple, single intervention of Cetirizine / Zyrtec®~     use can improve exercise performance of active individuals when acutely exposed to altitude.~     For this project, healthy subjects will perform steady state and progressive work rate~     exercise, endurance performance time trials, and repeated sprint performance time trials in~     the laboratory at a simulated altitude of 3000m (9900ft) after dosing with 10 mg of~     Cetirizine or a placebo in a repeated measures design.~   "
28613|NCT03192475|"~     The Pitt Retiree Study (PRS) disseminates a novel, yet practical, diabetes prevention program~     among Medicare eligible adults in Western Pennsylvania. This study will provide 4, and 12~     month outcome data (with a no treatment follow-up assessment at 24 months) to help determine~     whether a continued contact group telephone intervention is feasible and effective in~     enhancing health outcomes and physical functional ability in high risk adults (aged 65-80)~     with obesity and cardiometabolic risk factors .~   "
28614|NCT03192462|"~     Patients who have pancreatic cancer that has come back or has not gone away after treatment,~     including the standard treatment for this disease or patients who are not eligible for or~     have elected not to receive standard of care chemotherapy, and patients who will have surgery~     after treatment for pancreatic cancer are eligible for this study. This is a research study~     using special immune system cells called tumor-associated antigen (TAA)-specific cytotoxic T~     lymphocytes, a new experimental therapy.~      The proteins that are targeted in this study are called tumor-associated antigens (TAAs).~     These are cell proteins that are specific to the cancer cell. They do not show, or they show~     up in low quantities, on normal human cells. In this study, five common TAAs will be~     targeted. They are called NY-ESO-1, MAGEA4, PRAME, Survivin and SSX2. On a different study,~     patients have been treated and so far this treatment has shown to be safe.~      Investigators now want to try this treatment in patients with pancreatic cancer.~      These TAA-specific cytotoxic T lymphocytes (TAA-CTLs) are an investigational product not~     approved by the Food and Drug Administration.~   "
28615|NCT03192449|"~     Mass drug administration (MDA) of albendazole (ABZ) to school-age and pre-school-age children~     is the currently recommended strategy for controlling soil-transmitted helminthiasis (STH) in~     endemic areas. Recent mathematical modelling suggests that community-wide MDA will be~     required in order to interrupt transmission of STH. DEWORM3 aims to determine the feasibility~     of eliminating STH through expanded and intensified MDA strategies. In order to ensure~     rigorous trial results, it is crucial that the definition of such MDA coverage is informed by~     unbiased, empirical data. The Centro de Investigación Veterinaria de Tandil (CIVETAN) and~     Instituto de Investigaciones en Enfermedades Tropicales Universidad Nacional de Salta~     collaborate on scientific research related to pharmacokinetic studies of ABZ.~      This proposal describes the request for funding from DEWORM3 to conduct a study of the serum~     pharmacokinetic characteristics and urinary excretion of ABZ and its metabolites in~     non-infected human volunteers to better understand the use of urinary analysis of ABZ as a~     measure of MDA adherence in the context of DEWORM3.~   "
28616|NCT03192436|"~     Neuromodulation is a fast growing field that offers a wide range of applications for both~     understanding and treating the brain. Future research for non-invasive neuromodulation will~     need to elucidate the optimal frequency, duration, and intensity of stimulation for a variety~     of technologies and diseases. Closed loop stimulation is thus a promising research area that~     allows for responsive stimulation and real time symptom management. Our project is proposed~     to develop and test a novel noninvasive neuromodulation integrating transcranial focused~     ultrasound stimulation (tFUS) with electrophysiological source imaging (ESI-tFUS) to allow~     evidence-based neuromodulation for brain research and the management of brain conditions.~     Despite the recent developments and attention surrounding tFUS, relatively little is known~     about the mechanisms and optimal parameters of this stimulation technology. The addition of~     ESI neuroimaging, aimed at providing biomarkers to assess the effects of tFUS~     neuromodulation, could provide crucial necessary information regarding the neural response to~     the applied stimulation in real-time. In order for tFUS to be further developed and~     transformed into a robust neuromodulation technology, an integrated electrophysiological~     source-imaging-guided tFUS system to allow for individualized and responsive stimulation is~     needed.~      The purpose of this study is to develop and evaluate the proposed ESI-tFUS in human subjects~     using motor and somatosensory paradigms.~   "
28617|NCT03192423|"~     This study explores lumbar puncture operators stress associated with their performance of the~     procedure, across three experience levels: Experts, Intermediates, and Novices.~      The study will investigate the association of this potential stress to patient experienced~     stress and patient related outcomes of the lumbar puncture procedure.~   "
28639|NCT03192137|"~     The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy of~     ISV-305 (Dexamethasone in DuraSite® 2) compared to Vehicle in the treatment of inflammation~     and pain associated with cataract surgery.~   "
28640|NCT03192124|"~     To demonstrate a reduction of debris in knee synovial fluid as demonstrated by WBC cell~     counts before and after irrigation with Bactisure Wound Lavage.~   "
28618|NCT03192410|"~     The Alpha Omega Cohort is a prospective study of 4,837 state-of-the-art drug-treated Dutch~     patients aged 60-80 years who had a clinically diagnosed myocardial infarction up to 10 years~     before enrolment. During the first 40 months of follow-up, patients took part in an~     experimental study of low doses n-3 fatty acids (Alpha Omega Trial, ClinicalTrials.gov~     NCT00127452). At baseline (2002-2006), data on medical history, medication use, diet,~     lifestyle and other factors were collected by means of questionnaires. Patients were~     physically examined by trained research nurses and blood samples were obtained. Follow-up for~     vital status and cause-specific mortality is ongoing. The trial was approved by a central~     medical ethics committee (Haga Hospital, The Hague, The Netherlands) and all patients~     provided written informed consent.~   "
28619|NCT03192397|"~     This phase II trial studies how well chemotherapy, total body irradiation, and~     post-transplant cyclophosphamide work in reducing rates of graft versus host disease in~     patients with hematologic malignancies undergoing a donor stem cell transplant. Drugs used in~     the chemotherapy, such as fludarabine phosphate and melphalan hydrochloride, work in~     different ways to stop the growth of cancer cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Giving chemotherapy and total-body~     irradiation before a donor stem cell transplant helps stop the growth of cells in the bone~     marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy~     stem cells from a donor are infused into the patient, they may help the patient's bone marrow~     make stem cells, red blood cells, white blood cells, and platelets. Sometimes the~     transplanted cells from a donor can make an immune response against the body's normal cells~     (called graft versus host disease). Giving cyclophosphamide after the transplant may stop~     this from happening.~   "
28620|NCT03192384|"~     The head of nursing at University Hospital Coventry and Warwickshire (UHCW) plans to roll out~     an intervention across groups of hospital wards over the next four months. The intervention~     is designed to reduce falls as part of quality improvement for the hospital. However, the~     head of nursing has asked the University of Warwick to help with the scientific evaluation of~     the intervention - to find out whether and to what extent falls on the wards are reduced by~     the intervention. The University of Warwick will have two functions:~        1. To analyse data on falls to see if there has been a statistically significant drop in~          fall rates before and after the intervention has been implemented across these groups of~          wards~        2. To determine a random order in which the groups of wards receive the intervention as~          this will make it easier to distinguish cause and effect.~   "
28621|NCT03192371|"~     The purpose of this study is to evaluate the 1 year immunogenicity persistence of Rabipur in~     children 6-17 years of age, and compare the Zagreb regimen with the Essen regimen.~   "
28622|NCT03192358|"~     For individuals with neurodegenerative conditions, such as Amyotrophic Lateral Sclerosis and~     Parkinson disease, swallowing impairment (i.e., dysphagia) is a common and serious symptom.~     Dysphagia places the affected individual at risk for secondary health consequences, including~     malnutrition and aspiration pneumonia, and negatively affects quality of life.~      Thickened liquids are commonly recommended for individuals with dysphagia, as they flow more~     slowly and reduce the risk of entry into the airway. However, there is limited understanding~     about how changes in liquid thickness modulate swallowing physiology in individuals with~     neurodegenerative conditions, and previous reports have shown that increased liquid thickness~     may contribute to the accumulation of residue in the throat.~      The purpose of this study is to explore swallowing physiology and function in individuals~     with neurodegenerative conditions, across five levels of liquid thickness (thin,~     slightly-thick, mildly-thick, moderately-thick, and extremely-thick), and to identify~     boundaries of optimal liquid thickness, which maintain airway safety, without contributing~     to the accumulation of significant residue. Results from this study will help guide the~     clinical recommendations for thickened liquids in dysphagia management.~   "
28623|NCT03192345|"~     Primary Objectives:~      Dose escalation (Part 1)~      Part 1A (SAR439459 monotherapy)~        -  To determine the maximum tolerated dose (MTD) and/or maximum administered dose (MAD) of~          SAR439459 when administered intravenously as monotherapy in adult patients with advanced~          solid tumors.~      Part 1B (SAR439459 and REGN2810 combination therapy)~        -  To determine the MTD and/or MAD of SAR439459 administered intravenously in combination~          with REGN2810 administered intravenously in adult patients with advanced solid tumors.~      Dose expansion (Part 2)~      Part 2A (SAR439459 monotherapy)~        -  To determine optimal dose of SAR439459 administered intravenously in adult patients with~          advanced melanoma who have failed a prior therapy based on anti-PD-1 (programmed cell~          death-1) or anti-PD-L1.~      Part 2B (SAR439459 and REGN2810 combination therapy)~        -  To determine the objective response rate (ORR) of SAR439459 administered intravenously~          in combination with REGN2810 in adult patients with selected advanced solid tumors.~      Secondary Objectives:~        -  To characterize the pharmacokinetic (PK) profile of SAR439459 administered as~          monotherapy (Part 1A/2A) and in combination with REGN2810 (Part 1B/2B) and PK profile of~          REGN2810 in combination with SAR439459 (Part 1B/2B).~        -  To assess the immunogenicity of SAR439459 monotherapy (Part 1A/2A) and SAR439459 and~          REGN2810 combination (Part 1B/2B).~      Dose escalation (Part 1)~        -  To characterize the overall safety and tolerability profile of SAR439459 administered as~          monotherapy and in combination with REGN2810.~        -  To identify the preliminary recommended phase 2 dose (pRP2D) of SAR439459 as monotherapy~          or in combination with REGN2810.~      Dose expansion (Part 2)~        -  To determine the progression free survival (PFS), time to progression (TTP), ORR, and~          safety of SAR439459 as monotherapy and PFS, TTP and safety in combination with REGN2810~          in adult patients with selected advanced solid tumors.~        -  To confirm the optimal dose of SAR439459 administered in combination with REGN2810 (Part~          2).~   "
28624|NCT03192332|"~     Intravenous thrombolysis with recombinant tissue-type plasminogen activator (IV t-PA) has~     been the only proven therapy for acute ischemic stroke (AIS) for almost 20 years. Whether IV~     t-PA prior to endovascular clot retrieval is beneficial for AIS patients with a proximal~     vessel occlusion in the anterior circulation has currently become a matter of debate and is a~     relevant unanswered question in clinical practice.~      The main objective is to determine whether subjects experiencing an AIS due to large~     intracranial vessel occlusion in the anterior circulation will have non-inferior functional~     outcome at 90 days when treated with direct mechanical thrombectomy (MT) compared to subjects~     treated with combined IV t-PA and MT.~      The secondary objectives are to study causes of mortality, dependency and quality of life in~     these AIS patients.~   "
28625|NCT03192319|"~     The purpose of this study is to determine the optimal timing of zoster vaccination to induce~     both higher cell-mediated immunity and humoral immunity in adult patient aged over 50 with~     history of hematopoietic stem cell transplantation(HSCT).~   "
28641|NCT03192111|"~     This purpose of this study is to evaluate the effects of a single dose of entinostat on~     subjects with varying levels of renal impairment.~      The primary objective of this study is to evaluate the pharmacokinetics of a single dose of~     entinostat in adult subjects with mild, moderate and severe renal impairment compared to~     healthy mean-matched subjects.~      The secondary objective of this study is to evaluate the safety and tolerability of~     entinostat in adult subjects with mild, moderate, and severe renal impairment and in healthy~     mean-matched adult subjects.~   "
28642|NCT03192098|"~     A randomized controlled prospective clinical trial assessing the efficacy and safety of~     progressive esophageal dilation compared to conservative esophageal dilation in patients with~     severe benign esophageal strictures.~   "
28626|NCT03192306|"~     The purpose of this study is to determine if Merlin, a mixture of ethanol and glycolic acid,~     is safe and effective in the treatment of cold sores.~      Subjects who meet the requirements to participate in the study will be put randomly, and~     equally, into one of two groups: 1) a group receiving Merlin to treat their cold sore; or 2)a~     group receiving a placebo of just ethanol to treat their cold sore. Neither the subject nor~     the site will know which treatment they will be getting. Once the subject has been assigned~     to a treatment group, they will be given a kit containing a bottle of the treatment and~     special swabs to apply the liquid. The subject will be told to take the kit home and wait~     until they think they are starting to get a cold sore.~      Once a subject begins to see something that they think is the start of a cold sore, they are~     to immediately call the clinic. Once the clinic confirms that the subject is in fact starting~     to get a cold sore, the subject will be told to open the kit and begin treatment. From the~     start of treatment, there will be twelve (12) treatments, with either Merlin or placebo,~     applied six (6) hours apart, up to 3 per day, over the next 96 hours (4 days). Each treatment~     of Merlin or placebo is made up of three (3) applications given twenty (20) minutes apart,~     for a total of thirty-six (36) applications. For each application, the subject will use the~     special swab to put the Merlin or placebo solution on their cold sore.~      Subjects will need to report daily to the clinic for a minimum of 3 consecutive days, until~     either the cold sore is completely healed or 14 days from the start of treatment, whichever~     comes first. At each clinic visit the cold sore will be observed to determine at what stage~     it is at or if it has healed. The subject will also be asked how they are feeling.~      Subjects will also be told to record in a diary the time of each application of Merlin or~     placebo. They will also be asked to record the stage of their lesion and how much pain, if~     any, related to the cold sore, that they are feeling.~   "
28627|NCT03192293|"~     This is a prospective single arm open-label Phase 2 study utilising the combination of~     Fulvestrant, Metformin and Simvastatin in post-menopausal ER-positive metastatic breast~     cancer, with the primary endpoint being Clinical Benefit Rate (defined as complete response,~     partial response or stable disease, equal to or more than 24 weeks). The hypothesis is that~     the addition of Metformin and Simvastatin to Fulvestrant will improve the Clinical Benefit~     Rate from 40% (historical data from control arm of PALOMA-3 study) to 60%. A total of 28~     patients will be enrolled over a period of 24 months. Eligible patients will receive 500 mg~     Fulvestrant by intramuscular injection on days 1 and 15 of cycle one and then on day one of~     each subsequent cycle (28 days). Patients will be given 850mg oral Metformin twice-a-day~     (based on xenograft models which showed that Metformin had anti-tumor effects at a minimum~     dose of 1500mg per day), and 20mg oral Simvastatin every night (drawing reference from the~     investigators' group's window-of-opportunity study), daily throughout the cycle. As part of~     the in-build safety and tolerability design, all patients will have a lead-in period of 7~     days where they receive 850mg oral Metformin twice-a-day and 20mg oral Simvastatin every~     night. Special adverse events of interest include lactic acidosis, diarrhea, bloatedness,~     transaminitis and rhabdomyolysis. If no dose-limiting toxic effects (DLT) occur, Fulvestrant~     will be commenced, and considered the start of cycle 1. If DLT occurs in any of the patients,~     the combination of Metformin and Simvastatin will be modified for the affected patient as per~     protocol, with further monitoring for another 7 days. This combination will be deemed safe~     for that patient if no DLT occurs, following which cycle 1 can officially commence.~      At the time of study entry, blood samples will be drawn to establish baseline physiological~     parameters including fasting insulin, glucose, lipids and Homeostasis Model Assessment 2~     (HOMA2). In patients who have accessible tumor sites and are willing to provide tissue for~     translational research, pre- and post-treatment (at end of 8 weeks) biopsies will be taken~     for correlative biomarker studies. Patients will be evaluated on an 8-weekly basis for~     toxicities and efficacy assessments during the first 6 months of treatment, followed by~     12-weekly thereafter until disease progression, unacceptable toxicities, or patient~     withdrawal.~   "
28628|NCT03192280|"~     This trial will test the feasibility of various imaging devices to detect local skin~     inflammation prior to clinical manifestation.~   "
28629|NCT03192267|"~     The primary goal of this study is to investigate lung disease, through pulmonary function and~     high resolution chest CT, in newly diagnosed RA patients. Extra-articular disease occurs in~     approximately 50% of RA patients, with the lung being a common site of involvement.~      Investigators goal is to understand the prevalence of lung disease in early RA patients and~     to better characterize it through questionnaires, imaging, and serum studies. Additionally,~     the goal is to find novel biomarkers to predict lung disease in RA patients.~   "
28630|NCT03192254|"~     This research seeks to examine psychological factors that may impact relationship between~     incentives and health behavior engagement, specifically fruit and vegetable consumption.~     Additionally, it will compare the impact of two different incentive schedules on behavior~     engagement, one providing immediate rewards (i.e. rewards received on a daily basis) and~     another providing delayed rewards (i.e. rewards received at the end of the study period),~     with a control condition in which no rewards are offered. Study participants will provide~     reports of their fruit and vegetable consumption each day for three weeks, and in the two~     incentive conditions, they will receive small monetary rewards for their fruit and vegetable~     consumption. Following the three week reporting and reward period, participants will complete~     two additional assessments, measuring psychological constructs and behavior engagement~     following the cessation of rewards. The study will also examine how cognitive and~     anthropomorphic factors may contribute to intervention response and the effects on~     psychological constructs.~   "
28631|NCT03192241|"~     The primary objective of this study is to pilot an intervention of providing manual breast~     pumps at hospital discharge to low-income, first-time mothers and to generate initial~     estimates of the effect of this intervention on exclusive breastfeeding rates at 3 months (12~     weeks). In this pilot study, we will compare receipt of a breast pump and brief instructions~     of its use to the active control of receipt of a children's book and brief instructions about~     reading with baby. As a secondary objective, we will investigate mothers' attitudes and~     opinions about the manual breast pump intervention with the goal of fine-tuning it to best~     fit mothers' needs before a larger, multi-center trial. To support our objectives, we will~     examine the following specific aims:~        1. To test the intervention of providing low-income, first time mothers with a manual~          breast pump at hospital discharge on exclusive breastfeeding rates at 12 weeks.~           Hypothesis: Among low-income first-time mothers, receipt of a manual breast pump at~          hospital discharge will lead to improved exclusive breastfeeding rates at 12 weeks~          postpartum compared to receipt of a children's book.~        2. To use qualitative methods to determine best practices associated with successful~          implementation of a breast pump intervention to improve breastfeeding rates among~          low-income, first-time mothers.~        3. To test the effect of receiving a children's board book during the birth hospitalization~          on parents reading to the baby at 3 months (12 weeks).~   "
28632|NCT03192228|"~     Therapeutic education programs allows in diabetic patients to promote self-care and better~     perception of the disease~      Our multidisciplinary program of therapeutic education regroups in one day: individual~     interview, nutritional workshop, self-monitoring blood glucose workshop, physical activity~     and glycemic objectives workshop.~      At the end of the program, individual and personalized goals are given to the patient.~      This study aims to evaluate this program success rates and the psychological, anamnesis, and~     sociological factors linked to success.~   "
28633|NCT03192215|"~     Objectives~        -  Primary: To test the hypothesis that apixaban is superior to aspirin for the prevention~          of recurrent stroke in patients with cryptogenic ischemic stroke and atrial cardiopathy.~        -  Secondary: To test the hypothesis that the relative efficacy of apixaban over aspirin~          increases with the severity of atrial cardiopathy.~   "
28644|NCT03192059|"~     This is a Phase II study in patients with advanced and/refractory cervical cancer,~     endometrial carcinoma or uterine sarcoma.~      Patients will be treated with an immunomodulatory cocktail (Vitamin D, aspirin,~     Cyclophosphamide and Lansoprazole), followed by pembrolizumab, combined with radiation. In~     addition, patients will take Curcumin, a food supplement.~   "
28645|NCT03192046|"~     Parkinson disease (PD) is a progressive neurological disease that results in characteristic~     gait dysfunction. Gait problems include decreased velocity, decreased stride length,~     difficulty with initiation of gait, postural stability problems and alteration in joint~     kinematics.1 In this typically older patient population, these gait deviations affect their~     participation in household and community activities. The standard of care is currently~     focused on therapeutic exercise and cueing of various types (visual, auditory, verbal).~     Current interventions have not been demonstrated to markedly improve gait kinematics, so~     there is a need to identify interventions that could improve gait performance in this~     population. Lower extremity bracing is a common and well-established intervention for gait~     dysfunction with other populations, including stroke and brain injury. The braces allow for~     improved stability, sensory feedback, and consistent tactile cues to allow patients to have~     the best gait mechanics with each step. It is reasonable to hypothesize that appropriate~     bracing may have the potential to improve gait function and kinematics in PD since these~     patient often have gastroc-soleus weakness. Data from our early pilot studies indicates that~     bracing individuals with PD can positively impact their mobility. This includes improvements~     in velocity, step length, and dynamic balance. Additional data supported an upward trend in~     quality of life.~   "
28646|NCT03192033|"~     Over the past years, arterial closure systems have tended to replace manual compression to~     ensure hemostasis at femoral artery puncture points. Arterial closure systems reduce~     hemostasis and patient immobilization times, thus enabling early resumption of walking. These~     devices have contributed extensively to the development of outpatient stays for cardiology,~     vascular and neuro-radiology procedures.~      However, main arterial closure devices use different technology to close the arterial~     puncture point. For some, hemostasis is achieved by sealing the arteriotomy between two discs~     (an inner and an outer). For others, they are designed to close puncture sites delivering a~     single monofilament polypropylene suture mediated by needles.~      The investigators hypothesis is based on a different efficacy between both arterial closure~     devices for peripheral arterial disease (PAD) patients.~   "
28647|NCT03192020|"~     Trial is a prospective, randomized, controlled, outcome assessor-blinded, three armed~     parallel 1:1:1, multicenter trial. The research objective is to determine, which treatment~     strategy 1) primary percutaneous needle fasciotomy (PNF) followed by surgical limited~     fasciectomy (LF) in patients who do not respond to PNF, 2) primary collagenase clostridium~     histolyticym (CCH) followed by LF in patients who do not respond to CCH or 3) LF as the~     primary (and secondary) treatment modality is the most cost-effective in treating Dupuytren´s~     contracture.~   "
28648|NCT03192007|"~     The goals of this study are:~        -  To optimize and evaluate multiple kidney MRI methods; and~        -  To investigate the potential of MRI in the assessment of transplant kidney functions; To~          achieve these goals, we will perform pilot MRI studies with kidney transplant patients.~          We will study if MRI can reflect different levels of kidney function. The investigators~          will also evaluate if MRI can differentiate causes for declining kidney function.~          Finally, the investigators will explore how MRI measures changes before and after~          medical treatment for worsening kidney function.~      You may be invited for MRI exams with different exam options. An MRI exam may use either of~     two types of MRI machines at the CMRR: the 3T scanner and the 7T scanner. You may also be~     invited for a multi-session exam. A description of the MRI exam types with different exam~     options and the types of multi-session exams is provided later in this document.~   "
28649|NCT03191994|"~     To investigate the impact of a structured eight week exercise intervention as an add-on~     therapy in treating Major Depressive Disorder. Using behavioural techniques and neuroimaging~     to measure changes in brain function following an exercise intervention in people with~     clinical depression. By correlating changes in the hippocampus with changes in HPA axis~     hormones, inflammatory cytokines and growth factors it is possible to determine which of the~     biochemical markers is most predictive of improved neural function.~   "
28650|NCT03191981|"~     This is a multi-centre phase I/II trial with an initial dose finding phase for~     cyclophosphamide and lenalidomide combined with fixed dose pembrolizumab for patients with~     relapsed or relapsed / refractory multiple myeloma (MM) that have had at least 1 prior line~     of therapy~   "
28651|NCT03191968|"~     This study will evaluate the feasibility of delivering a supervised physical activity program~     plus standard exercise counseling (SPA+EC) versus a supervised physical activity plus~     motivationally-enhanced behavioral counseling (SPA+BC) in prostate cancer survivors (PCS).~     Fifty participants (n=25) will be randomized to receiving SPA+EC or SPA+BC (n=25). We~     hypothesize that PCS receiving the SPA+BC intervention will result in greater increases in~     objectively-assessed physical activity compared with PCS receiving the SPA+EC intervention.~   "
28652|NCT03191955|"~     One way cancer affects people is through weight loss. During this weight loss (called~     cachexia), all types of body tissue are lost, but there is a greater rate of muscle loss than~     fat. Cancer patients with cachexia show decreased quality of life, decreased response to~     treatment (e.g. chemotherapy), increased complications from surgery, and shorter overall~     survival. The Investigators aim to identify molecular (and patient) factors within the~     tissues and bodily fluids of patients with cancer and cachexia in order to identify patients~     at risk of weight loss, and identify potential therapies. For this, the Investigators aim to~     take patient samples (muscle, fat, tumour, urine and blood) whilst patients are asleep~     (general anaesthesia) during their operation to remove the cancer. These samples, and similar~     samples taken in previous studies, will be analysed in the laboratory. Along with the sample~     taking, the Investigators aim to perform nutritional assessments of patients before and after~     surgery to get an accurate picture of their weight loss. This will include simple~     measurements (e.g. height/weight), and computer reanalysis of their initial diagnostic~     computed tomography (CT) scans (this study will not require any additional scans for~     patients). The Investigators also aim to assess how their muscles function, by asking them to~     perform walk tests and wear a physical activity meter, and assess their quality of life~     through questionnaires. The Investigators aim to perform nutritional and functional~     assessments pre-surgery and at 2-3 appointments post-surgery, up to a period of 12 months. At~     these timepoints, the Investigators also aim to take repeat blood and urine samples, and~     where possible, one additional thigh muscle biopsy. Repeated assessments allow comparison~     between cancer and cured states. The study will take 2 years for patient recruitment.~      For comparison, the Investigators also aim to examine similar tissue and fluid samples~     (except tumour) from non-cancer patients who are having surgery for benign conditions (e.g.~     hernia).~   "
36947|NCT03083002|"~     Purpose of the study is to determine transcriptomics, metabolomics and proteomics features of~     liver cirrhotic tissue in patients with hepatocellular carcinoma (HCC) and to find a~     correlation with the risk of developing HCC and survival.~   "
28653|NCT03191942|"~     This project aims to study the effects of treatment characteristics on myopia control in~     orthokeratology by investigating the effects of modified treatment zone by reducing the lens~     back optic zone diameter on the effect of myopia control. The project will be a two-year~     randomized, double-masked (examiner - mask axial length only) study conducted at The Hong~     Kong Polytechnic University recruiting sixty Chinese subjects aged between 6-11. Subjects~     will be randomly assigned to two ortho-k groups. The Control group will wear KATT BeFree lens~     with a BOZD of 6mm while the Test group will wear KATT MC lens with a modified BOZD of 5mm.~   "
28654|NCT03191929|"~     This study assessed the potential of Health Information Technology (HIT) to improve the~     screening, diagnosis, and treatment of depression and post-traumatic stress among LEP~     Southeast Asians. Should this intervention be found to be effective, the principles of the~     HIT technology could be easily adapted for screening in other languages to increase the~     recognition and treatment of depression and PTSD in primary care settings.~   "
28655|NCT03191916|"~     The investigators hypothesize that multi-session anodal tDCS (atDCS) of the left dorsolateral~     prefrontal cortex (LDLPFC) will induce long-lasting effects in improving cognitive function~     and reducing cognitive fatigue and fatigability in PD patients with MCI.~   "
28656|NCT03191903|"~     This is a multi-center, randomized, double-blind, parallel group, active comparator~     controlled trial to evaluate the efficacy and safety of a single injection of Cingal for the~     relief of joint pain in subjects with OA of the knee.~   "
28657|NCT03191890|"~     This study is designed to generate a comprehensive survey of the use on the market of the~     Anecova device within its intended indications according to the Instructions For Use. The~     Anecova Registry is part of the Anecova quality system, to enable the Post Marketing~     Surveillance and the Post Market Clinical Follow-up.~   "
28658|NCT03191877|"~     Randomized controlled trial in Obstetrics and Gynecology department (MULTI-CENTRIC).To~     measure the effect of coffee consumption on intestinal motility after caesarean section for~     the patient who fulfills the criteria. Then they will be randomized to 3 groups. The primary~     outcome and secondary outcome will be measured.~   "
28659|NCT03191864|"~     Eosinophilic esophagitis (EoE) is an inflammatory disease of the esophagus, characterized by~     eosinophilic infiltration and gastrointestinal symptoms. Swallowed, topically acting~     corticosteroids, such as fluticasone, appear to be effective in resolving acute clinical and~     pathological features of EoE.~      APT-1011 is an orally disintegrating tablet (ODT) formulation of fluticasone propionate. This~     study is designed to compare the efficacy and safety of APT-1011 with placebo in adults with~     EoE for an initial 12-week treatment period, followed by an additional 40-week maintenance~     treatment phase. Histologic response, pharmacokinetics, and dysphagia will be assessed.~   "
28660|NCT03191851|"~     Ascites is the accumulation of fluid inside the abdomen. This can happen when the liver fails~     due to a substantial amount of scarring (cirrhosis). Patients (pts) must have this fluid~     drained and as cirrhosis progresses, patients will require drainage of ascites repeatedly on~     a regular basis, leading to frequent hospitals visits and increased complications.~      The current drainage device is slow and doesn't always drain completely so pts have to return~     repeatedly to keep symptoms under control.~      A new device (called Melody) has been developed and specifically designed for the purpose of~     draining ascites fluid, which the Investigators expect to drain faster and completely.~      This study will compare the volume of ascites drained using the new 'Melody' catheter device~     with that used in standard NHS practice. If the melody catheter device is confirmed as~     superior to the current device this would improve patient experience (less frequent visits to~     hospital and increased length of time between visits).~      With fewer procedures performed per patient, the pressure on the NHS would be greatly reduced~     in terms of time and costs.~   "
28661|NCT03191838|"~     The primary purpose of this study is to investigate whether audiovisual distraction can lead~     to a reduction in standard of care administered intraoperative propofol consumption compared~     to those who receive propofol sedation alone in adults having total hip or knee replacement~     surgery under spinal anesthesia.~   "
28662|NCT03191825|"~     The purpose of the trial is to test the adjunctive effect of adding a lapse management system~     to a best practices web- and mobile smoking cessation program.~   "
28663|NCT03191812|"~     The tDCS & Dual Tasking study will compare the effects of transcranial Direct Current~     Stimulation (tDCS) targeting three different cortical regions (as well as sham stimulation)~     on dual task standing and walking in older adults with and without a recent history of~     recurrent falls.~   "
28664|NCT03191799|"~     This is a phase IIIb, single arm, open-label, multi-center study to evaluate the safety and~     tolerability of emicizumab in participants with congenital hemophilia A who have documented~     inhibitors against Factor VIII (FVIII) at enrollment. Approximately 200 participants, aged 12~     or older, will be enrolled in this study and are expected to be enrolled at approximately 85~     sites globally. Participants will receive an initial weekly dose of prophylactic emicizumab~     subcutaneously for 4 weeks, followed by a weekly maintenance dose subcutaneously for the~     remainder of the 2-year treatment period.~   "
28665|NCT03191786|"~     This Phase III, global, multicenter, open-label, randomized, controlled study will evaluate~     the efficacy and safety of atezolizumab (an anti-programmed death-ligand 1 [anti-PD-L1]~     antibody) compared with a single agent chemotherapy regimen by investigator choice~     (vinorelbine or gemcitabine) in treatment-naïve participants with locally advanced or~     metastatic non-small cell lung cancer (NSCLC) who are deemed unsuitable for any~     platinum-doublet chemotherapy due to poor performance status (Eastern Cooperative Oncology~     Group [ECOG] performance status of 2-3).~   "
28666|NCT03191773|"~     Autologous T cells engineered to express an anti-CD19 chimeric antigen receptor (CAR) will be~     infused back to patients with refractory /relapsed B cell malignancies, including lymphoma~     and leukemia. The patients will be monitored after infusion of anti-CD19 CAR-transduced T~     cells for safety,adverse events, persistence of anti-CD19 CAR-transduced T cells and~     treatment efficacy.~   "
28667|NCT03191760|"~     The purpose of the study is to see if Behavioral Activation and Social Engagement for PTSD~     (BASE for PTSD), an individual therapy for PTSD, will help Veterans with PTSD 1) through~     improved understanding of how PTSD affects them, 2) by reducing ways in which they avoid~     meaningful activity due to PTSD, 3) by enabling them to do more of the things they really~     care about, and 4) by improving, strengthening, and building up their social supports.~   "
28671|NCT03191708|"~     Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of~     coronary stenosis. The purpose of the FAVOR II China study is to evaluate the diagnostic~     accuracy of on-line QFR with FFR as the reference standard. The secondary purpose is to~     compare the diagnostic accuracies between online QFR and online QCA, with FFR as the~     reference standard.~   "
28672|NCT03191695|"~     Cerebral Palsy (CP) defined as a group of permanent impairments that is originating from~     non-progressive disorders that develop in the immature brain. CP leads activity limitations~     of movement and posture development. Motor problems in CP are usually accompanied by sensory~     and perceptual disorders, cognitive disorders, communication and behavioral disorders,~     epilepsy, and secondary musculoskeletal system problems. The first 20 years of life is~     characterized by rapid growth and specific changes in physical, social, and psychological~     development. Social participation and independence of children and youth are related to the~     changes in this period. Participation can be identified as being involved in life situations~     and it reflects the social aspect of functionality. The problems which can be come across in~     life situations are identified as participation limitation. In literature, no adequate study~     has investigated the functional inadequacy, activity and participation of children with CP;~     this project has been planned in order to specify the importance in rehabilitation~     interventions more detailed. This project aims to specify whether the functional levels~     correspond to the activity and participation limitations of children with CP living in Ankara~     city center and determine the effects of their functional status on activity, participation~     and quality of life. This investigation will be pioneer in indicating the activity and~     participation limitations of children with CP. According to the results, these limitations~     will be overcome and the quality of life of children with CP will be increased. The CP~     follow-up database in Ankara will be specified so their physical activity and participation~     levels will be followed periodically and CP profile will be determined in Ankara.~   "
28673|NCT03191682|"~     This study is carried out to test the safety of a study drug called PRL3-ZUMAB. PRL3-ZUMAB is~     an investigational drug that has not yet been approved by the Food and Drug Administration~     (FDA) or any other regulatory authorities for commercial purposes. This is the first study in~     which PRL3-ZUMAB will be given to humans. The study drug has been tested in animals and was~     found to be well-tolerated with minimal side effects. This research study will test different~     doses of the drug to see which dose is safest in people.~   "
28674|NCT03191669|"~     Vaccines in MS patients have been controversial, in particular hepatitis B vaccine in the 90s~     and more recently human papillomavirus vaccine. There was an important flu incidence during~     the winter 2016-2017 that has revealed a low exposure to the flu vaccine in health~     professionals in France. Vaccine exposure of Multiple sclerosis (MS) patients has not been~     evaluated yet.~      Objectives The primary objective is to evaluate exposure to the flu vaccine in patients with~     MS during the 2016-17 campaign. Secondary objectives are to evaluate exposure to mandatory~     vaccines, non mandatory vaccines, in the context of immunoactive treatments; to identify~     potential limitations to vaccines in general in patients with MS.~      Methods Cross-sectional observational multicentric study, performed in Auvergne-Rhône-Alpes~     (France).~      Data will be collected through an auto-questionnaire administered during an out-patient visit~     or hospitalization, during a two-week period.~      Statistical analysis Description of the percentage of patients exposed to the flu vaccine,~     and to other vaccines. Stratification according to demographics (age, sex) and MS related~     criteria (disability level, relapse in the year before, disease-modifiying drug) Expected~     results Vaccine exposure of patients with MS will be put in perspective with the general~     population exposure. The study can provide information regarding potential reluctance of~     patients with MS towards vaccines. This could lead to develop specific communication tools~     for patients with MS and/or health professionals.~   "
28675|NCT03191656|"~     This is a post market trial to be conducted at several sites in Germany. The device has CE~     approval in the EU. The purpose of this observational registry is to collect post market data~     in consecutive patients treated with the IASD System II, to further evaluate efficacy, safety~     and quality of life outcomes as a new treatment for patients with heart failure in a real~     world practice setting.~   "
28676|NCT03191643|"~     Description of the role of a post-operative external beam radiotherapy in patients with~     differentiated thyroid cancer.~   "
28677|NCT03191630|"~     Inactivity is a common problem among older kidney transplant recipients (KTRs) and is~     associated with their high incidence of obesity and cardiovascular problems which are the~     leading cause of death for KTRs. However, the combination of SystemCHANGE activity trackers~     holds promise for increasing physical activity of KTR patients post-surgery.~      This pilot study will incorporate Fitbit health trackers with an intervention of questions~     about influences to physical activity in a population of kidney transplant recipients who are~     at particularly high risk of cardiovascular disease and death.~   "
28678|NCT03191617|"~     The objective of the study is to compare two human milk fortifiers with different protein~     content and LCPUFA in a group of very low birth weight infants.~   "
28679|NCT03191604|"~     This study tests the impact of narrow band imaging (NBI) on endoscopists' accurate detection~     of visible lesions and dysplasia in patients with Barrett's esophagus, as well as the effect~     of NBI on the choice of primary treatment modality among endoscopists performing endoscopic~     eradication therapy (EET).~   "
28680|NCT03191591|"~     The First 1000 Days (conception to age 2) is a crucial period for the development and~     prevention of obesity and its adverse consequences in mother-child pairs and their families.~     The overall aim of the First 1000 Days program is to work across early-life systems to~     prevent obesity, promote healthy routines and behaviors, address social determinants of~     health, and reduce health disparities among vulnerable children and families at the MGH~     Chelsea and Revere HealthCare Centers, and DotHouse Health.~      The study aims to simultaneously implement and evaluate an obesity prevention program across~     early life systems to reduce the prevalence of obesity risk factors within racial/ethnic~     minority families, close the gap in maternal-child health disparities, and assess and address~     social determinants of health.~   "
28693|NCT03191422|"~     This study aims to explore if the LSVT BIG® - a motor learning based treatment program~     designed for rehabilitation of people with Parkinson's disease could be beneficial for~     chronic stroke rehabilitation. A single-case experimental design with two adult participants,~     will be monitored for performance on self-selected goals before, during and after~     participating in the treatment program.~   "
28681|NCT03191578|"~     The RUTIVAC-1 study is a Phase I Clinical Trial designed to evaluate the systemic and mucosal~     immunological response and provide safety information after the use of RUTI® administration~     to individuals with NMIBC.~      The study will enroll individuals treated with Transurethral resection of bladder tumor~     (TURBT), diagnosed to have high-risk Non-muscle invasive bladder cancer (NMIBC) and suitable~     candidates for BCG therapy and who meet all eligibility criteria.~      Forty individuals will be recruited and randomized 1:1 to receive two subcutaneous shots of~     25 μg RUTI® or placebo. After vaccination, individuals will receive the standard intravesical~     Bacillus Calmette-Guerin (BCG) therapy with induction course (weekly BCG for six weeks) and~     maintenance course (three courses of weekly BCG for three weeks at 3, 6 and 12 months after~     induction).~      After the last intravesical BCG administration (BCG15, end of Interventional Phase)~     immunological assays will be performed and data will be analyzed. At the end of the~     Interventional Phase the blind will be opened, except for the study physicians who will~     remain blind during all the follow-up. All the individuals will be followed up for three~     years since TURBT.~   "
28682|NCT03191565|"~     BACKGROUND: Borderline Personality Disorder (BPD) is a serious and debilitating mental~     disease characterized by difficulties with emotion regulation that leads to unstable and~     self- destructive behavior and relationships. The prevalence of BPD is between 1% and 5% in~     the Scandinavian population with similar prevalence rates found in US epidemiologic surveys.~     BPD increases the risk for suicide by 4-fold, while patients with comorbid BDP and tendency~     to self-harm have a further 2-fold attenuated risk. BDP is difficult to treat, and even more~     difficult when co-occurring with other disorders. Dialectical Behavior Therapy (DBT) is the~     best validated treatment for BPD, showing medium to large effect sizes as compared to~     treatment as usual for anger, parasuicidality (suicide attempts without an intention to die)~     and poor mental health. DBT uses self-monitoring as the mainstay of treatment, which helps~     patients regulate their emotions by means of emotional regulating skills, and reduce problem~     behavior. Self-monitoring has traditionally been done by means of daily paper diaries. The~     latest developments in smartphone applications have generated alternatives for ecological~     momentary assessments of problematic behavior that even prompt patients to practice skills~     targeting emotion regulation. An example of this is Monsenso's DBT self-monitoring mHealth~     application (mHealth means mobile health, public health supported by mobile phones). Such~     applications may enhance treatment success in BPD patients, as they are available to patients~     at all times.~      OBJECTIVES: To evaluate the Monsenso's mHealth app with respect to clinical efficacy as an~     adjunct to DBT-psychotherapy treatment and utility as a way to measure outcomes in BPD~     patients.~      METHODS: The study will be a 2-year multi center, randomized controlled trial. In both~     conditions patients will be followed for one year. Self report data of DBT-skills-use,~     positive and negative affect, Standardised self report questionnaires on Emotion regulation~     ability; functioning; borderline symptoms. will be given pre, post and every month. The~     treatment arm (n=50) will receive the mHealth app that includes coaching suggestions and~     instructed how to use it. The control arm (n=50) will only use a pen and paper based~     self-monitoring, as traditionally used in DBT-treatment.~      STUDY ENDPOINTS: Primary: mean number of days passed per new DBT-Skill learned. Secondary:~     Borderline personality disorder(BPD)-symptoms, Emotion regulation ability, ratio~     positive/negative affect.~   "
28683|NCT03191552|"~     To evaluate the effects and feasibility of lycra based compression garment called Stabilizing~     Pressure Input Orthosis (SPIO) vest on posture and balance during sitting and gross manuel~     dexterity, parent satisfaction with the garment and to to compare 2 hours vs 6 hours of daily~     wear time.~   "
28684|NCT03191539|"~     This study aims to evaluate more objectively, through an imaging technique such as~     ultrasound, changes in joints and entheses of patients with active psoriatic arthritis (PAs)~     who will start treatment with Apremilast after the failure of other therapies such as~     synthetic DMARD (metrotrexato , Leflunomide ...).~      The hypothesis of the study is that the technique of ultrasound can demonstrate the efficacy~     of Apremilast in the treatment of patients with active PAs~   "
28685|NCT03191526|"~     The objective of this study is to assess the efficacy and safety of KW-0761 after intravenous~     injections in subjects with HTLV-1 associated myelopathy (HAM) in Japan.~   "
28686|NCT03191513|"~     The purpose of this study is to investigate whether there are differences in postprandial~     metabolic indices following interesterified fats used commercially versus the corresponding~     un-interesterified blend.~   "
28687|NCT03191500|"~     This is a prospective, multicenter, single-arm clinical trial to evaluate safety and efficacy~     of a steerable catheter in the establishment of vascular intervention access. five centers~     participate in this study. The total enrollment number is 68. In the procedure of vascular~     interventional surgery or angiography diagnosis, the steerable catheter are used to building~     vascular interventional access. Evaluate the safety and efficacy of the product, by the~     observation and record the relative index of subjects intraoperative and postoperative~     (discharge) before and after 30 days .~   "
28688|NCT03191487|"~     The primary objective of this study is to compare an experimental organization for~     chemotherapy session planning based on early, standardized, and prioritized means of data~     transmission via secure e-mail (laboratory results) and the use of a smart phone (for~     clinical toxicity data) compared to the regular organization, in terms of the rate of~     prescriptions of chemotherapy prepared at the latest the day before a session and then~     administered in full (over a 6-month observation period) among colorectal cancer patients in~     need of cancer treatment in an outpatient setting.~   "
28689|NCT03191474|"~     CCTG 602 is a multisite demonstration project to evaluate the effectiveness of facilitated~     linkage to PrEP using a community-based transgender PrEP outreach worker (T-POWr) versus~     standard of care (SOC).~   "
28690|NCT03191461|"~     This is a cross-sectional pilot study. The investigators seek to obtain early information~     pertaining to the relationship between measurements of myocardial perfusion reserve and~     myocardial fibrosis after receipt of Anthracycline-based chemotherapy (≥2 years prior).~   "
28691|NCT03191448|"~     Currently, it is not known what the dimensional changes might be following a molar site~     extraction which has been grafted with FDBA and covered with a collagen wound dressing. The~     purpose of the proposed study is to examine the clinical healing following ridge preservation~     using freeze dried bone allograft (FDBA) with a collagen wound dressing barrier (CollaPlug®)~     in a molar extraction site.~      I~   "
28692|NCT03191435|"~     In diabetic individuals, changes in ventilatory muscle strength and lung function have been~     demonstrated over the years. The onset and progression of chronic complications in diabetes~     should be avoided by reaching glycated hemoglobin (HbA1c) levels below 7%. The control of~     glycemia through the measurement of HbA1c is fundamental to avoid complications. The~     inspiratory muscle training has been used in several clinical situations, and may be an~     alternative for individuals with type 2 diabetes mellitus who have difficulties performing~     conventional exercises. The long-term effect of inspiratory muscle training on glycemic~     control has not been tested yet. The aim of this study is to evaluate the effects of~     inspiratory muscle training on glycemic control in individuals with type 2 diabetes.~   "
28694|NCT03191409|"~     End stage renal disease (ESRD) is the last stage (stage 5) of chronic kidney disease (CKD).~     Abnormalities of cognitive function and high levels of depression or anxiety incidence are~     characteristic of hemodialysis patients. In this research project, the investigators subject~     in ESRD patients starting hemodialysis as the carrier. Based on the longitudinal research~     design, using multimodal neuroimaging data，combining with the interact relationship between~     changes of brain morphology, the dysfunction of resting-state and-task state with cognitive~     impairment and abnormal emotions.Establish brain structure-function change model associated~     with dialysis progression, Explore imaging markers of central and disease development~     characteristics in ESRD patients. the investigators attempt to clarify the core mechanism of~     kidney-brain axis damage, thus provide evidence for early cognitive-behavioral therapy to CKD~     patient.~   "
28695|NCT03191396|"~     This study is conducted in Europe. The aim of the study is to compare the effect of~     semaglutide subcutaneous (s.c., under the skin) 1.0 mg once-weekly to liraglutide s.c.1.2 mg~     once-daily on blood sugar levels after 30 weeks of treatment in people with type 2 diabetes.~      The study will last approximately 9 months (37 weeks). Each participant will have 7 visits at~     the clinic and 3 phone calls with the study doctor. At the visits, participants will have a~     number of tests, for example: general health checks, blood samples, heart and eye checks etc.~     Participants will also fill in some forms about their health and satisfaction with their~     diabetes treatment.~   "
28696|NCT03191383|"~     The purpose of this study is to assess the safety, reactogenicity and immunogenicity of the~     investigational GSK RSV vaccine in pregnant women aged 18 to 40 years and infants born to the~     vaccinated women~   "
28697|NCT03191370|"~     To compare the effectiveness of reducing discomfort during flexible nasal endoscopy using~     simple distraction techniques compared to topical anaesthetic spray and a control group that~     does not receive topical anaesthetic spray or a distraction technique.~   "
28698|NCT03191357|"~     This protocol is designed to facilitate the recruitment, screening and registry of Military~     Service Members (SMs) and individuals eligible for care in the Department of Defense (DoD)~     healthcare system. This protocol will serve as an entry point for SMs, retirees and other~     beneficiaries, to facilitate their participation in Center for Neuroscience and Regenerative~     Medicine (CNRM)-sponsored clinical research studies at participating CNRM sites.~     Specifically, this protocol will be comprised of an initial evaluation of participants, to~     include questionnaires, a blood draw, and neuroimaging. This evaluation will enable~     investigators to direct participants to CNRM-sponsored natural history, observational, or~     interventional protocols that are most relevant to the individual interests and needs of each~     participant. Other approved CNRM protocols may continue to recruit participants directly into~     their respective studies, and may refer participants to this study.~      The objective of this protocol is to develop a broad-spectrum military subject recruitment~     database that will collect and store preliminary data on research participants who are~     interested in and potentially eligible for current and future CNRM sponsored studies. The~     effectiveness of the recruitment methods utilized in this protocol will be evaluated to~     determine the most successful outreach approaches and recruitment tools for the enrollment of~     participants, including both active and reserve component SMs along with others who are~     eligible for care in the DoD healthcare system, who have experienced traumatic brain injury~     (TBI), psychological health (PH) concerns, or are interested in participating in studies as~     controls. Control participants may include (i) those with exposure to primary blast without~     the development of TBI, (ii) those with physical injuries without experiencing head injury,~     and (iii) healthy participants (non-injured, non-TBI, non-PH).~   "
28699|NCT03191344|"~     after established the Intraoperative Parathyroid Scores System (IPSS) for thyroidectomy we~     further extented the clinical value of Intraoperative Parathyroid Scores System in Treatment~     decisions of calcium treatment time and improve recognition skills of parathyroid in~     Clinicians~   "
28700|NCT03191331|"~     The aim of this pilot study is to conduct a dietary intervention for overweight (body maas~     index BMI≥25) and obese (BMI≥30) pregnant women in two maternity care clinics and explore the~     effect of the intervention on gestational weight gain and the prevalence of gestational~     diabetes between the intervention and control groups.~   "
28701|NCT03191318|"~     The aim of this study is to compare two postoperative recovery pathways namely, enhanced~     recovery after surgery (ERAS) pathway and conventional recovery pathway after laparoscopic~     sleeve gastrectomy with respect to outcomes including hospital stay, postoperative pain and~     other postoperative outcomes.~   "
28702|NCT03191305|"~     In past few years new anticoagulants have been developed which directly inhibit thrombin or~     factor X.factor x inhibitor is available in Pakistan. The superior efficacy of Rivroxaban has~     been shown in Deep Venous Thrombosis in EINSTEIN study (3).Its definite superiority in~     prevention of embolic stroke in nonvalvular atrial fibrillation is evidenced by the study~     ROCKET AF (4). With Rivroxaban no monitoring is required, and also there are no drug~     interactions .There are few pilot studies of using Rivroxaban in cerebral venous thrombosis.~     This study is therefore required to find its efficacy in CVT patients as well as its~     comparison with Coumadin~   "
28703|NCT03191292|"~     The purpose of this study is to establish a bacterial epidemiology in patients who present a~     prosthetic joint infection and for which a surgery is necessary. At the time of the first~     surgery, as the bacteria responsible for the infection are not known, a probabilistic~     antibiotherapy is initiated at once after the surgical treatment. The antibiotherapy is then~     adapted to the bacteria from samples collected during the surgery when they are identified~     (the delay is 14-21 days).~      The study will focus on bacteria identified on samples collected during the surgery; the~     delay between the implantation of the prosthesis and the presentation of symptoms will be~     considered : more than one year vs. less than one year.~      Investigators assume that there is not the same type of bacteria involved in those two cases~     of delays and that the probabilistic antibiotherapy may be not optimal when the symptoms are~     presented more than one year after implantation of the prosthesis. A probabilistic~     antibiotherapy not adapted lead to develop resistance for the bacteria and decrease the~     chance to cure the patient (increasing of relapse).~      The result of this study will allow medical doctors to have an optimal probabilistic~     antibiotherapy, depending on the delay between implantation of the prosthesis and the~     presentation of the symptoms.~   "
28704|NCT03191279|"~     The study aims to assess the effect of first aid from bystanders on survival, admission~     length, and need of ICU-stay for trauma victims.~   "
28715|NCT03191136|"~     This is a phase 1, open-label, randomized, single dose, crossover clinical trial to assess~     the effect of food on the pharmacokinetics of YHD1119 in healthy male volunteers.~      Hypothesis: YHD1119 is showing equal equal pharmacokinetics in fasted and fed state.~   "
28716|NCT03191123|"~     This clinical trial aims to compare hepatectomy with Transarterial Chemoembolization (TACE)~     for Hepatic Cellular Cancer With Solitary Huge Tumor (≥5cm). All patients will be divided~     into two group.One group will receive hepatic resection, while an another equivalent group~     patients will be treated with Transarterial Chemoembolization.~   "
28705|NCT03191266|"~     At least 60% of Veterans with an alcohol use disorder will relapse within 6 months of~     treatment, irrespective of the type of treatment they receive. This indicates that currently~     available interventions for treating AUD in Veterans are not effective in helping them~     achieve long-term sobriety. Repetitive transcranial magnetic stimulation (rTMS) is a brain~     stimulation method that is at the forefront of innovative, non-invasive, and safe treatments~     for AUD. However, there have been no studies that specifically determined the effectiveness~     of rTMS treatment for Veterans with AUD. This project will evaluate the effectiveness of rTMS~     treatment in promoting long-term abstinence in Veterans suffering from AUD. Assisting~     Veterans in achieving long-term and sustained sobriety is critical because it is associated~     with the best medical, cognitive, psychiatric, and psychosocial recovery from AUD.~   "
28706|NCT03191253|"~     UCSF and Project Open Hand (POH), a community based organization in San Francisco which~     provides meals and groceries to chronically ill clients in the Bay Area, have partnered to~     conduct an initial randomized controlled trial (RCT) of the Changing Health through Food~     Support (CHEFS) pilot intervention implemented by POH. The intervention consists of providing~     comprehensive, medically-appropriate food support, individual nutritional counseling, and~     group-based nutritional education over 6 months to low-income clients who have been diagnosed~     with HIV in order to improve their viral load and health-related quality of life (primary~     outcomes) as well as depression, ART adherence, food security and diet quality (secondary~     outcomes). We will randomize 200 participants to the intervention (n=100) or control (n=100).~     Participants will be followed for 6 months. The investigators will assess outcomes at~     baseline and 6-month follow-up using a quantitative survey and blood draws. In addition, the~     investigators will conduct a qualitative study at follow-up in a subset of participants to~     understand perceived impacts, barriers and facilitators.~   "
28707|NCT03191240|"~     The investigators aimed to evaluate the effect of AMCPR (Augmented-Medication CardioPulmonary~     Resuscitation: administration of additional vasopressin to titrate to arterial diastolic~     blood pressure over 20 mmHg) on cardiopulmonary resuscitation results and outcomes in~     out-of-hospital cardiac arrest patients.~   "
28708|NCT03191227|"~     The aim of the Cork and Kerry Study Phase II (Mitchelstown cohort recruited 2010-11) is to~     provide an updated profile of glucose tolerance status, cardiovascular health and their~     related factors in an Irish adult general population sample and to compare the findings with~     those obtained during baseline assessment of Phase I of the Cork and Kerry study (1998) and~     the rescreen (2008).~   "
28709|NCT03191214|"~     The purpose of the study is to assess the temperature changes that take place throughout the~     body in a real world setting, when a patient is given general anaesthesia. Specifically we~     will investigate the movement of body heat from the core to the peripheries at the beginning~     of surgery. This will be measures with a series of temperature sensors and infrared~     thermography~   "
28710|NCT03191201|"~     In this study the investigators aim at addressing potential relationships between iron stores~     and glucose homeostasis. Iron (i.e. Ferric Carboxymaltose) will be perfused to~     pre-menopausal, iron-deficient non-anaemic women suffering from a chronic fatigue syndrome~     and parameters related to glucose homeostasis, parameters related to metabolic syndrome and~     inflammation will be measured before and after the intervention.~   "
28711|NCT03191188|"~     Hypothyroidism, defined by elevated thyrotropin (TSH) levels, is a common endocrine~     complication of chronic kidney disease that has been associated with impaired quality of life~     and cardiovascular complications. While levothyroxine is one of the most frequently~     prescribed medications in chronic kidney disease patients, little is known about its efficacy~     and safety in this population. This study will investigate 1) whether levothyroxine~     adequately lowers thyrotropin (TSH) levels to therapeutic target ranges, and 2) if thyroid~     hormone replacement improves quality of life and cardiovascular markers, without leading to~     wasting in dialysis patients.~   "
28712|NCT03191175|"~     The clinical challenges confronting patients with HIV has shifted over the past 10 years from~     acquired immunodeficiency syndrome to chronic diseases including atherosclerosis,~     neurocognitive disorders, and osteoporosis. Chronic low grade inflammation and monocyte~     activation have been consistently associated with comorbidities in HIV patients. Indeed,~     recent studies indicate that inflammatory mediators including IL-6, IL-1, sCD14 and s CD163~     produced by monocytes, but not T-cell activation, predict Non-AIDS-related events in~     virologically suppressed HIV-infected persons treated with combined antiretroviral therapy~     (cART), highlighting the important role of monocyte activation in the occurrence of~     comorbidities in cART-treated HIV infected patients. Yet, the underlying molecular pathways~     of persistent monocyte activation in cART treated HIV-infected patients remains incompletely~     characterized. Our preliminary results: 1/ establish a link between the activation of the~     inflammasome, the increased of pyrimidine-derived metabolites and the cardiovascular risk in~     a cohort of elderly patients; 2/ show that treated HIV-patients are characterized by~     increased soluble IL-1b or IL-18 in their blood suggesting that the inflammasome pathway is~     activated.~      Objectives: In this study we will characterize the molecular pathways underlying persistent~     monocyte activation in treated HIV patients, through the implication of the activation of the~     inflammasome machinery: 1. Characterization of NOD like Receptor (NLR) expression in~     monocytes for IL-1b and IL-18 secretion (inflammasome activation); 2. Characterization of~     circulating metabolites that active the inflammasome machinery; 3. Evaluation of the link~     between the activation of the inflammasome, the increased of circulating metabolites and the~     non-AIDS related comorbidities.~   "
28713|NCT03191162|"~     A phase 2 clinical trial to evaluate the the efficacy of different benznidazole regimens~     (300mg/day for 60 days, 150mg/day for 60 days, and 400mg/day for 15 days) for the treatment~     of chronic Chagas disease in adult patients. The efficacy is assessed through the proportion~     of patients with negative parasitaemia measured by Polymerase Chain Reaction (PCR) during the~     first 12 months after starting treatment. The study will be performed in Spain, Brazil,~     Argentina and Colombia.~   "
28714|NCT03191149|"~     This phase II trial studies how well osimertinib works in treating patients with non-small~     cell lung cancer with EGFR exon 20 insertion mutation that is stage IIIB-IV or has come back.~     Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth.~   "
28717|NCT03191110|"~     The main aim of this observational, prospective cohort study is to assess associations of~     diet and other lifestyle factors with colorectal cancer recurrence, survival and quality of~     life.~   "
28719|NCT03191084|"~     Marijuana is one of the most widely used substances. This study will characterize the~     persistence of cannabis' (CNB's) acute effects on cognitive test performance and simulated~     driving over a several hour time period. The data obtained from simulated driving, cognitive~     tests, and biological assays of THC will be used in analyses aimed at identifying what tests~     or combination of tests predict both recent use and driving impairment risk.~      Eligible participants will undergo a full day screening visit, if still eligible they will~     come to Hartford Hospital in Hartford, Connecticut to take part in the full study.~     Participation requires overnight stays between each of the five study visits. On each of the~     study days participants are dosed with either a low dose of THC marijuana, a high dose of THC~     marijuana or placebo marijuana, (the low and high doses are repeated once each, order in~     which the study drug is given is double blind and chosen at random.)~   "
28720|NCT03191071|"~     The study is randomized clustered pragmatic trial whose objective is to decrease unnecessary~     antibiotic prescription in adult patients with lower respiratory tract infection managed at~     primary care level in Switzerland, using a simple algorithm based on 2 point of care test~     results~   "
28721|NCT03191058|"~     This trial aims to assess the efficacy and tolerability of Magnetic Seizure Therapy (MST) as~     an alternative to electroconvulsive therapy (ECT) for depression. Even with multiple~     medication trials, 30 - 40% of patients will experience a pharmacologically resistant form of~     illness. The ineffectiveness of current treatments for major depressive disorder (MDD)~     coupled with the economic burden associated with the disorder engenders a need for novel~     therapeutic interventions that can provide greater response and remission rates.~   "
28722|NCT03191045|"~     This study will: 1. validate MRI motility method with concomitant perfused manometry method~     in healthy adult participants. 2. measure exploratory endpoints of interest including GI~     fluid volumes in 21 adult healthy volunteers studied twice.~   "
28723|NCT03191032|"~     The implementation of early sensory re-education (SR) techniques, aimed to preserve the~     cortical hand area, such as the use of audio-tactile interaction, becomes an important~     strategy to obtain also a better sensory function. The aim of this study was to investigate~     sensory function outcomes (threshold monofilaments, two-point discrimination test, STI and~     DASH) and cortical responses (fMRI) in patients submitted to an early protocol of SR of the~     hand with a sensor glove model. After surgical repair of median and/or ulnar nerves, 17~     participants were divided into two groups: the training group, trained on the protocol with~     the sensor glove model, and the control group, untrained. After six-month follow-up, no~     difference was observed between groups, related to sensory function, especially tactile~     gnosis. Despite this, the early training with this sensor glove model seems to provide some~     type of cortical audio-tactile interaction, contributing to previous studies that focus in~     early SR of the hand using the integration of different sensory modalities.~   "
28724|NCT03191019|"~     The purpose of this study is to determine whether a mobile-phone based intervention is~     effective in supporting smoking cessation among Chilean women~   "
28725|NCT03191006|"~     Using double blind, randomized controlled design to investigate the short-term therapeutic~     effects of function of customized insoles on children with developmental delays~   "
28726|NCT03190993|"~     The purpose of the current study is to test if weight change is differentially affected by~     consumption of foods that are identical in carbohydrate (i.e. sugar) but vary in food form~     over 1 month.~   "
28727|NCT03190980|"~     Background: It was long believed that newborns could not experience pain. As it is now~     documented that newborns have all the necessary systems to perceive pain, pain management can~     no longer be ignored.~      Pharmacologic agents are not recommended in neonates for pain relief in minor procedures and~     still there is debate regarding the efficacy of oral glucose, in different strengths, on~     alleviation of pain among neonates.~      Aim: The objective of this study is to assess the efficacy and safety oral administration of~     glucose, in different concentrations, on pain relief in full term neonates undergoing heel~     prick test.~      Methods: The investigators will conduct a prospective, randomized, double blind placebo~     controlled trial to investigate the effect of glucose solution on alleviating the pain of~     heel prick test in around 360 healthy full term newborns who will be randomly allocated to~     one of three groups (around 120 neonates in each group): First group will receive 5% glucose,~     second group will receive 30% glucose and third group will receive sterile water as a~     placebo, 2 minutes prior to the procedure.~      Specially trained nurses will take turns to carry out blood sampling. Neonatal pain will be~     assessed by the Neonatal Infant Pain (NIPS) as well as by duration of crying, changes in~     heart rate, respiratory rate and oxygen saturation.~   "
28728|NCT03190967|"~     Background:~      Sometimes breast cancer spreads (metastasizes) to the brain. Researchers want to study new~     treatments for brain metastases. The drug Temozolomide is approved to treat brain tumors.~     Researchers want to see if combining it with the drug T-DMI prevents the formation of new~     metastases in the brain.~      Objective:~      To study if Temozolomide with T-DM1 lowers the chance of having new metastases in the brain.~      Eligibility:~      Adults at least 18 years old with a HER2-positive breast cancer that has spread to the brain~     and was recently treated with stereotactic radiation or surgery.~      Design:~      Participants will be screened with~        -  Medical history~        -  Physical exam~        -  Heart tests~        -  A scan (CT) that makes a picture of the body using a small amount of radiation~        -  A scan (MRI) that uses a magnetic field to make an image of the brain~        -  Blood tests.~        -  Pregnancy test.~      The study will be done in 3-week cycles.~      All participants will get T-DM1 on Day 1 of every cycle through a small plastic tube inserted~     in an arm vein.~      Some participants will also take Temozolomide capsules by mouth every day.~      Participants will keep a medication diary.~      During the study, participants will also:~        -  Repeat most of the screening tests.~        -  Answer questions about their general well-being and functioning.~      Participants will have lumbar puncture at least 2 times. A needle is inserted into the spinal~     canal low in the back and cerebrospinal fluid is collected. This will be done with local~     anesthesia and with the help of images.~      Participants will be asked to provide tumor samples when available.~      Participants will have a follow-up visit about 1 month after stopping the study drug. They~     will be contacted by telephone or email every 3 months after that.~   "
38691|NCT03060252|"~     This is a prospective registry study to surveil early liver injuries caused by Zhuanggu~     Guanjie Pill (ZGGJ Pill) through a non-intervention observational way. And attempt to~     establish a predictive model to screen susceptibilities to ZGGJ Pill.~   "
28729|NCT03190954|"~     Background:~      The chemical messenger dopamine carries signals between brain cells. It may affect addiction.~     Heavy use of pain medicines called opioids may decrease the amount of dopamine available to~     the brain. Researchers want to study if decreased dopamine decreases self-control and~     increases impulsiveness.~      Objective:~      To learn more about how opiate use disorder affects dopamine in the brain.~      Eligibility:~      Adults 18-65 years old who are moderate or severe opiate users~      Healthy volunteers the same age~      Design:~      Participants will first be screened under another protocol. They will:~        -  Have a physical exam~        -  Answer questions about their medical, psychiatric, and alcohol and drug use history~        -  Take an MRI screening questionnaire~        -  Give blood and urine samples~        -  Have their breath tested for alcohol~      Participants will have up to 3 study visits.~      They will have 2-3 positron emission tomography (PET) scans. A radioactive chemical will be~     injected for the scans. Participants will lie on a bed that slides in and out of the~     donut-shaped scanner. A cap or plastic mask may be placed on the head.~      Vital signs will be taken before and after the PET scans.~      Participants will get capsules of placebo or the study drug. They will rate how they feel~     before, during and after.~      Participants will have their breath and urine tested each day.~      Participants will have magnetic resonance imaging (MRI) scans. They will lie on a table that~     slides into a cylinder in a strong magnetic field. They may do tasks on a computer screen~     while inside the scanner.~      Participants will have tests of memory, attention, and thinking.~      Participants will wear an activity monitor for one week....~   "
28730|NCT03190941|"~     Background:~      A new cancer therapy involves taking white blood cells from a person, growing them in the~     lab, genetically modifying them, then giving them back to the person. This therapy is called~     gene transfer using anti-KRAS G12V mTCR cells.~      Objective:~      To see if anti-KRAS G12 V mTCR cells are safe and can shrink tumors.~      Eligibility:~      Adults at least 18 years old with cancer that has the KRAS G12V molecule on the surface of~     tumors.~      Design:~      In another protocol, participants will:~      Be screened~      Have cells harvested and grown~      Have leukapheresis~      In this protocol, participants will have the procedures below.~      Participants will be admitted to the hospital.~      Over 5 days, participants will get 2 chemotherapy medicines as an infusion via catheter in~     the upper chest.~      A few days later, participants will get the anti-KRAS G12V mTCR cells via catheter.~      For up to 3 days, participants will get a drug to make the cells active.~      A day after getting the cells, participants will get a drug to increase their white blood~     cell count. This will be a shot or injection under the skin.~      Participants will recover in the hospital for 1 2 weeks. They will have lab and blood tests.~      Participants will take an antibiotic for at least 6 months.~      Participants will have visits every few months for 2 years, and then as determined by their~     doctor.~      Visits will be 1 2 days. They will include lab tests, imaging studies, and physical exam.~     Some visits may include leukapheresis or blood drawn.~      Participants will have blood collected over several years.~   "
28731|NCT03190928|"~     Background:~      Follicular lymphoma is a type of cancer of the lymph nodes. Lab studies are important for~     cancer research. They help scientists better understand differences in the cancer biology of~     different patients. Researchers want to collect serial samples over time from people with~     follicular lymphoma to help them design future treatments.~      Objective:~      To collect a variety of samples from people with follicular lymphoma to study how these~     diseases progress and respond to treatment.~      Eligibility:~      Adults at least 18 years old who have been diagnosed with, but have not yet had any treatment~     for, follicular lymphoma.~      Design:~      Participants will be screened with medical history and physical exam. They will answer~     questions about daily functioning. They will have blood and urine tests. They may have scans~     and have tissue samples taken.~      Participants will be monitored about every 4 months for up to 2 years. They will repeat~     screening tests. They will have a cheek swab. A small brush will be rubbed against the inside~     of the cheek to wipe off some cells.~      Participants will have imaging scans about every 8 months for up to 2 years.~      Participants may have a bone marrow aspiration and biopsy. The hipbone will be numbed with a~     small needle.~      A needle will be put into the hipbone, and about 2 tablespoons of bone marrow will be taken~     out through the needle.~      Participants will continue being monitored every 6 months for up to 5 years, then 1 time a~     year.~   "
28732|NCT03190915|"~     This phase II trial studies how well trametinib works in treating patients with juvenile~     myelomonocytic leukemia that has come back or does not respond to treatment. Trametinib may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
28733|NCT03190902|"~     Computer-assisted rehabilitation of attention deficits in pediatric Multiple Sclerosis and~     ADHD patients recruited during the study Cognitive impairment in Pediatric Onset Multiple~     Sclerosis: research of biomarkers predictive of cognitive impairment progression.~   "
28734|NCT03190889|"~     The overall goal of this project is to reduce risk of second anterior cruciate ligament (ACL)~     injury in vulnerable populations (active athletes between 14 = 24 years old) through the~     identification of relative injury risk groups based on subject-specific movement patterns~     prior to second injury, as well as through the determination of effect for differential~     rehabilitation protocols following initial ACL reconstruction and prior to return to sport.~     As nearly one-third of athletes who have a primary ACL injury and return to sport will~     experience a secondary injury, results from the proposed work will allow us to prospectively~     identify high risk patients who are the most appropriate recipients of enhanced treatment,~     including targeted training, which may reduce the risk of second ACL injury. Secondary ACL~     injury has the potential to end athletic careers, promote the development of osteoarthritis,~     and have debilitating effects on quality of life. Hence, the information gathered in this~     investigation will offer ACL injured athletes the optimal potential to reduce or potentially~     prevent these negative health effects before they are initiated.~   "
28735|NCT03190876|"~     With a prevalence of up to 25%, seroma formation is among the most common complications of~     body contouring procedures such as abdominoplasty. Small amounts of fluid are reabsorbed by~     the body spontaneously, however, larger seroma volumes need to be evacuated via puncture~     aspiration to prevent wound healing disturbances and infection, leading to major patient~     discomfort and a prolonged hospital stay. There is increasing controversy regarding the~     efficacy of surgical drains in seroma prevention. This study compares the incidence rate of~     seroma in three study arms with different usage of drains.~   "
28736|NCT03190863|"~     Motor imagery has shown promising results to optimize tenodesis grasp in individuals with~     C6-C7 tetraplegia. However, efficacy of using motor imagery to improve grasping after~     tetraplegia requires further study with higher level of evidence. In addition, controlling~     covert practice remains difficult due to the absence of overt movements. However, similar~     brain activity measured during both over and cover movements makes possible to provide visual~     information about the covert practice performance using neurofeedback.~      The Investigators thus designed this multicentric randomized controlled trial to investigate~     the effect of motor imagery with or with no visual neurofeedback on grasping capabilities~     after C6-C7 tetraplegia. They hypothesized that providing neurofeedback based on brain~     activity measured by electroencephalography namely knowing the covert practice performance~     would results in greater grasping improvement in response to practice as compared to motor~     imagery practice alone.~   "
28737|NCT03190850|"~     This study aims to evaluate the effect of inspiratory muscle training on sleep apnea in the~     elderly. The patients screened will be randomized and allocated into two groups, intervention~     and control. In the intervention group, the patients will perform the exercises with the~     inspiratory muscular training apparatus called Powerbreathe with progressive load, according~     to its inspiratory muscular force. The control group will perform the same exercises, with~     the same apparatus, but without load.~   "
28738|NCT03190837|"~     The study aims are to: a) identify the long-term natural history of Gaucher disease, b)~     evaluate long-term treatment efficacy of enzyme replacement therapy (ERT) and substrate~     reduction therapy (SRT), and c) identify potential long-term complications of this disorder.~     These aims will be accomplished through long-term record review of individuals with all three~     types of Gaucher disease.~   "
28739|NCT03190824|"~     Open-label, single-arm, multi-center, Phase IIa study to evaluate the efficacy, safety, and~     immunological response of OBP 301 in patients with unresectable/unresected metastatic~     melanoma. This proof of concept study will be undertaken in male and female patients with~     unresectable Stage III and IV melanoma. Patients with unresectable/unresected mucosal~     melanoma may be enrolled after consultation with the Medical Monitor.~   "
28740|NCT03190811|"~     The purpose of this study is to compare the clinical efficacy and toxicity of anti-PD-1~     monoclonal antibody alone with anti-PD-1 monoclonal antibody plus autologous dendritic~     cells-cytokine induced killer cell (DC-CIK) immunotherapy in advanced tumor~     patients.Furthermore,to characterize response to therapy we intent to evaluate the role of~     cell-free DNA (cfDNA) and immune repertoire based on the next generation sequencing.~   "
28741|NCT03190798|"~     RESEARCH HYPOTHESIS~        -  In subjects with T2DM and HF, effect of canagliflozin will be superior to placebo for~          the change from baseline in PCWP after a single dose (6 hours post-dose) and after 4~          weeks.~        -  Treatment with canagliflozin will be well tolerated over 4 weeks.~   "
28742|NCT03190785|"~     The benzoic acid derivatives sodium and potassium benzoate are preservatives that are~     commonly added to food and beverages to inhibit microbial growth and prevent spoilage. In the~     US the major source of benzoate intake is beverages. Studies have shown that piglets or~     chicks fed low levels of benzoic acid have greater feed efficiency and gain more weight than~     control fed animals. It has also been shown that benzoic acid inhibits the release of a key~     metabolic hormone, leptin, from isolated adipocytes (fat cells). Inadequate leptin levels~     result in increased appetite, decreased metabolic rate, weight gain, insulin resistance and~     increased diabetes risk.~      The primary aim of the proposed research is to directly determine if benzoate consumption in~     human volunteers results in lower levels of leptin, decreased metabolic rate and increased~     insulin resistance. If so this would implicate benzoic acid as an obesogen and would help~     inform more effective approaches to obesity prevention and treatment. A secondary aim of the~     study is to establish a connection between benzoate exposure and biomarkers in urine that can~     be used to help treat obese patients.~   "
28743|NCT03190772|"~     The study aimes at identifying whether positive expectations have an impact on the way~     depressive participants experience emotions in the form of sadness.~   "
28744|NCT03190759|"~     Asthma is a heterogeneous disease, usually characterized by chronic airway inflammation. It~     is defined by the history of respiratory symptoms such as wheeze, shortness of breath, chest~     tightness and cough that vary over time and in intensity, together with variable expiatory~     airflow limitation. This definition was reached by consensus, based on consideration of the~     characteristics that are typical of asthma and that distinguish it from other respiratory~     conditions .~      Asthma is a problem worldwide, with an estimated 300 million affected individuals .It appears~     that the global prevalence of asthma ranges from 1% to 18% of the population in different~     countries .~   "
28745|NCT03190746|"~     It is hypothesized that one or several of these 6 single nucleotide polymorphisms (SNPs)~     (rs2246704, rs2853884, rs3747158, rs4820059, rs7291050, and rs933226) in the YWHAH gene could~     be related to RA disease severity.~   "
28746|NCT03190733|"~     In this study, a randomized, prospective, multicenter, open cohort study was conducted to~     investigate patients with acute leukemia (14～60-year-old) with different ATG doses (10 mg /~     kg and 12.5 mg / kg ) in fludarabine, busulfan, cyclophosphamide and antilymphocyte globulin~     (FBCA) pretreatment protocol of Haploidentical hematopoietic stem cell transplantation~     (haplo-HSCT). The purpose is to compare the incidences of chronic graft vs host disease~     (cGVHD) in haplo-HSCT recipients receiving different dose ATG and one year leukemia relapse~     after transplantation. The main objective was to investigate the optimal dose of ATG for~     decrease cGVHD and not increase one year relapse leukemia after haplo-HSCT. Its significance~     is to provide evidence-based medical evidence to reduce the occurrence of cGVHD and to~     improve the quality of life of patients with haplo-HSCT.~   "
28747|NCT03190720|"~     This study aims to investigate the effect of a mobile community based on a smart phone~     application to enhance physical activities of breast cancer survivors.~   "
28807|NCT03189914|"~     This will be a Phase 1a/2b multicenter 2-stage study. Phase 1 will be conducted as a~     dose-finding, open-label study of oral RX-3117 administered in combination with Abraxane® to~     subjects with metastatic pancreatic cancer. After completion of the Phase 1 portion, a Phase~     2a study will be conducted using a 2 stage, open-label design, of RX 3117 and Abraxane® in~     combination to treat subjects with metastatic pancreatic cancer as first line therapy.~   "
28748|NCT03190707|"~     The aim of the project is to develop and evaluate an interdisciplinary and cross-sectorial~     intervention targeting pregnant women with psychosocial vulnerabilities. The objective is to~     1) detect depression, anxiety and personality disorders in the pregnant women, 2) to increase~     knowledge sharing across the health care sectors and 3) strengthen the parents' parenting~     skills and thereby support a secure attachment between parents and child and thus promoting~     the child's well-being.~      The overriding hypothesis is that an early multi-stringed, interdisciplinary and~     cross-sectorial intervention, with a long-term perspective from the early pregnancy~     throughout the child's first years of life, can effectively prevent disorders in the~     parent-child relation. The approach is to detect and treat depression, anxiety and~     personality disorders in the mother and strengthen the parents' parenting skills in families~     with maternal psychosocial vulnerabilities. The hypothesis indicates that the over-all~     intervention will result in improved interaction between child and parents which will make it~     possible to detect higher maternal sensitivity and a higher level of well-being among both~     children and parents in the intervention group compared to the control group.~      The projects' specific hypotheses are;~        -  A systematic screening for anxiety, depression and personality disorders in the~          midwifery consultation will imply more pregnant women with symptoms of anxiety,~          depression and personality disorders being detected and offered treatment in the~          intervention group compared to the control group.~        -  Knowledge sharing across health care sectors will improve by the implementation of a~          joint consultation involving the vulnerable pregnant woman/families, the midwife and the~          health visitor and by a systematic transmission of information when the woman leaves the~          post-natal ward and is transferred to the health visitor.~        -  Parental skills in psychosocial vulnerable pregnant women and their partners can be~          strengthened by a parental training program and by education and dialogue about~          perceived challenges and breast-feeding. Parents in the intervention group will~          therefore gain greater knowledge on what it takes to make breast-feeding work~          successfully, be able to interact more appropriate with their children, and improve~          their mentalization skills and experience less stress compared to parents in the control~          group.~   "
28749|NCT03190694|"~     This study tests the hypothesis that dapagliflozin lowers proteinuria in patients with~     non-diabetic chronic kidney disease.~   "
28750|NCT03190681|"~     The purpose of this study is to evaluate the impact of methylphenidate, a mixed dopaminergic~     and noradrenergic agent, onto the different components of motivation: decision-making, effort~     allocation and instrumental learning.~   "
28751|NCT03190668|"~     The purpose of this research study is to compare the current standard of care for~     prophylactic Cefazolin administered every 3 hours intravenously with continuous infusion of~     Cefazolin during pediatric spinal surgery.~   "
28752|NCT03190655|"~     Burn injury is the result of an energy transfer that destroys the skin and adjacent tissues.~     Partial thickness burn wounds are painful and difficult to manage. The aim of burn treatment~     in partial thickness burns is to promote rapid wound healing, decrease pain, protect wound~     from infections, minimize scar formation and functional impairment In recent years, there are~     progressive development of new dressing material with a variety of option for depth adapted~     wound management. Many wound dressings are available for superficial and partial thickness~     burns. Hydrogel based wound dressing provides good biocompatibility with the skin and mucosa~     and promotes hydration of the wound bed.~      Aluminaid wound dressings is a hydrogel based wound dressing that is integrated with~     aluminium that was designed to reduce acute pain in the treatment of superficial and partical~     thickness burn injuries.~      Up to date, no evidence regarding integrated with aluminium sheet in hydrogel based wound~     dressings for the use in partial thickness burns. Therefore this trials is aimed to evaluate~     the efficacy and safety of Aluminaid versus Hydrogel for the treatment of partial thickness~     burns.~   "
28753|NCT03190642|"~     The current standard of care at the Oral and Maxillofacial Department at the CDHA is the use~     of one gram of methylprednisolone administered intravenously prior to orthognathic surgery.~     This is largely based on the work of Habal. The administration of one gram of~     methylprednisolone can be concerning for the anesthesiologist since this is an unusually~     large dose of steroid in comparison to use in other surgical specialties. As with most~     medications, the chances of steroid-related complications increase with increasing doses of~     steroids.~      The researchers are proposing a prospective, double-blind randomized control trial to~     determine if a smaller dose of methylprednisolone (125mg) can be used safely and effectively~     instead of one gram of methylprednisolone.~   "
28754|NCT03190629|"~     Compared to conventional hemodialysis (HD), on-line hemodiafiltration (OL-HDF) achieves a~     more efficient removal of uremic toxins and reduces inflammation, which could favourably~     affect nutritional status. The aim of this study was to evaluate the 1-year effect of OL-HDF~     on nutritional status and body composition in prevalent HD patients.~   "
28755|NCT03190616|"~     Limited agents have been approved after standard first and second line treatment. Regorafenib~     and Trifluridine/Tipiracil (TAS-102) are still not approved in China.Apatinib has shown~     significant efficacy in refractory advanced gastric cancer regarding PFS and OS with~     controllable toxicity.This study is aimed to explore the efficacy,safety as well as~     predictive biomarker in advanced colorectal cancer failed to standard therapy in Chinese~     population.~   "
28756|NCT03190603|"~     Axial Spondyloarthritis (SpA) is a kind of inflammatory arthritis which includes ankylosing~     spondylitis. Common symptoms of axial SpA are inflammatory back pain, morning stiffness,~     peripheral arthritis, enthesitis. Controlling aforementioned symptoms are one of the goal in~     treatment, and another goal is preventing bony ankylosis of axial skeleton such as spine.~     Ankylosis can limit range of motion and lower the quality of life.~      Non-steroidal antiinflammatory drug (NSAID) and Tumor necrosis factor (TNF)-a inhibitor are~     the current treatment options for axial SpA. These medications can improve pain and stiffness~     of axial SpA patients, however preventing bony ankylosis is not proven. Current study showed~     attenuating inflammation at early stage could prevent further bony destruction and ankylosis~     in axial SpA. Present study is designed to discover the therapeutic effect of NSAID whether~     NSAID could recover the early inflammatory bony change (bone marrow edema at MRI) and prevent~     further bony change.~   "
28757|NCT03190590|"~     Noninvasive stimulation of the central nervous system, including transcranial magnetic~     stimulation (TMS) and transcranial direct current stimulation (tDCS), has been increasingly~     used in the investigation of cortical plasticity. The purpose of our study is to understand~     mechanistically—at the neurophysiological and systems levels—how the brain learns new motor~     skills. We propose to study the acquisition, consolidation, and retention of motor skill~     learning in healthy subjects. At the behavioral level, we will use movement kinematics to~     quantify and characterize movement, which allow us to infer functional strategies used by the~     brain to reduce movement errors. At a neurophysiological level, we will use TMS to document~     changes in cortical circuitry, which will allow us to infer neuroplastic changes possibly~     subserving these strategies. At a systems level, we will enhance motor system excitability~     using tDCS, which will enable us to infer the contribution of the stimulated area to the~     motor system's ability to learn new skills.~   "
28838|NCT03189511|"~     The purpose of this study is to elucidate the effects of Fluvastatin on brown adipose tissue~     activity in humans.~   "
28758|NCT03190577|"~     Familial amyloid neuropathy due to transthyretin gene mutations (TTR-FAP) is a rare autosomal~     dominant inherited disease resulting in the abnormal multi-system deposition of amyloid~     proteins. These deposits produce a multi-organ disease. AP is usually fatal 10 to 15 years~     after onset of symptoms if untreated. The prevalence of the disease remains still poorly~     understood and usually the search for this pathology is done in a third line of~     investigation. So the average time to diagnosis is extremely long, from 12 to 24 month. Now~     that the investigators have etiological treatment ( famidis (Vyndaqel®) and Diflunisal~     (Dolobid)) of this disease, it is essential to be able to detect FAP patients as early as~     possible. With this study, investigator decided to test for TTR mutation all patients~     presented with neuropathy of unknown etiology at the first line of investigation. The goal of~     this study is to evaluate the prevalence of FAP-TTR among neuropathy and defined the best~     strategy to test this population for TTR mutations.~   "
28759|NCT03190551|"~     The primary aim of this study is to compare needle shaft visibility between the~     retroclavicular approach and costoclavicular approach for infraclavicular brachial plexus~     block in patients undergoing elective upper limb surgery. Secondary aim is to investigate the~     differences between the two groups in sensorial block success rate, block performance time,~     block performance related pain, motor block success rate, surgical success rate,~     complications, patient satisfaction, use of supplemental local anesthetic, use of analgesic.~   "
28760|NCT03190538|"~     Nonalcoholic steatohepatitis (NASH) is now recognised as an increasing clinical problem in~     children. Steatosis without significant liver cell injury or fibrosis is the most common form~     of nonalcoholic fatty liver disease (NAFLD) in both adults and children. Studies in the adult~     population have variably suggested that steatosis is a benign nonprogressive condition and~     NASH is recognised as a potentially serious condition with significantly risk of morbidity~     and mortality.~      A growing body of evidence suggests that children with NASH frequently show histopathological~     features that differ from those of adults. The prevalence of this pattern in a wide range of~     paediatric cases as well as other histopathological lesions and their relevance and~     prognostic significance in children with NAFLD remains to be determined. Thus the~     investigators would like to conduct a study of biopsies and clinical information to document~     the histological features of paediatric NAFLD, to explore the natural history of paediatric~     NAFLD, and to determine the frequency and prognostic value of these features.~   "
28761|NCT03190525|"~     The primary objective is overall survival (OS) as predicted by baseline self-reported EORTC~     QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life~     Questionnaire-Core 30) fatigue scale ratings, independently from other prognostic factors for~     OS in multiple myeloma (MM), including the clinically-based prognostic frailty score.~   "
28762|NCT03190512|"~     There is a relationship between depression and periodontal disease. This relationship may be~     double-sided. A psychological state such as anxiety, depression, body image, and self-esteem~     may be affected from the symptoms of periodontal disease.~   "
28763|NCT03190499|"~     Childhood cancers cover a wide range of diseases; leukemia, central nervous system cancers~     and lymphomas are the most common ones among them. During medical treatment children with~     cancer are at risk of neuromuscular and musculoskeletal complications such as reduced muscle~     strength, gross and fine motor performance impairment, decreased energy consumption. These~     neuromuscular and musculoskeletal complications can affect dynamic balance, endurance and~     quality of life of the children. Childhood cancers have negative effects on sleep. The aim of~     this study is to identify the status of sleep, fatigue, and quality of life in children with~     various types of cancer and to examine the relationship between these conditions.The general~     situation of children will be determined according to findings from this study.~   "
28764|NCT03190486|"~     Crying is the primary signaling strategy available to the human newborn for eliciting~     parental care. Yet, the investigators only have superficial understanding of the information~     carried by cries, and how this information is perceived by parents. Using modern tools of~     sound processing and functional Magnetic Resonance Imaging (fMRI) experiment, this study aims~     to investigate cry-induced brain activation in adult depending on the cry's acoustic~     properties expressing various degrees of stress and distress levels. For that, Adults will be~     tested inside a fMRI magnet to determine their brain activations elicited by different babies~     cries according to whether the cry was evoked in a pain situation or not. The cerebral~     activity will be investigated in relation to acoustic features of cries (e.g. with pitch~     and/or roughness variations). To test if the gender or parentally of adult listeners~     influence their perceptions and brain responses, the task will be applied to 2 different~     groups (men and women not-parents). The hypothesis is that the brain of adult listeners will~     be able to discriminate adequately the intensity of the pain mediated by the cries. This~     process should involve brain areas such as the insular and the orbito frontal cortex that are~     known to participate in the integration of pain intensity and pain controls. The experiment~     should also determine which one of the acoustic features is able to transmit pain and to~     recruit brain areas involved in pain processes.~   "
28765|NCT03190473|"~     Indication for use: The Svelte DES is indicated for improving coronary luminal diameter in~     patients with symptomatic heart disease, including patients with non-ST elevation MI due to~     discrete de novo native coronary artery lesions. The treated lesion length should be less~     than the nominal stent length with a reference vessel diameter of 2.50 mm - 4.00 mm~   "
28766|NCT03190460|"~     Approximately one in three older adults fall annually and it is the primary cause of~     traumatic injury in older adults. While exercise and balance programs have been shown to be~     effective in reducing fall risk, maintaining behavior change is known to be difficult. Thus~     additional interventions need to be validated to add to our current armamentarium to reduce~     falls in older adults. Cognitive training (CT) involves exercises that target specific~     cognitive tasks, such as memory or processing speed. It has been speculated that routinely~     performing such tasks may increase functional ability. Recent work has pointed to an~     increased risk of falls in community-dwelling older adults who have alterations in specific~     cognitive tasks. Thus the purpose of the proposed study is to demonstrate the feasibility and~     to explore the effectiveness of a 16 week CT intervention to reduce risk and incidence of~     fall and improve outcomes up to 1 month post-intervention in a group of community dwelling~     older adults at risk for fall.~   "
28767|NCT03190447|"~     Surgical wounds are covered to prevent bleeding, absorb the exudates and provide a barrier~     against external contamination. Currently, in Corporació PT after orthopedic surgery,~     traditional occlusive dressing of sterile gauze and non-woven hypoallergenic adhesive tape is~     placed. In many cases the appearance of blistering caused by the use of these conventional~     dressings is observed, which increases the risk of infection, pain and the final cost of the~     procedure. There are other types of dressings that could improve these aspects but~     comparative data are not currently available. Main objective: to identify the dressing that~     better preserves the integrity of the skin.~      Design: Prospective randomized comparative study of 5 types of dressings used in total knee~     and hip arthroplasty surgical wounds (TKA and THA).~      Secondary Objectives: To identify the dressing that provides greater advantages and minor~     inconveniences in TKA and THA surgery.~      Study population: Patients older than 18 years undergoing fast track primary TKA or THA. 110~     patients~   "
28768|NCT03190434|"~     This study is designed to demonstrate that the performance of the AL-SENSE developed by~     Common Sense Ltd. is safe and effective and can be used to indicate if the patient may be~     experiencing an amniotic fluid leakage or a water breaking. The AL-SENSE is an extended~     shelf-life product that is technically simple, fast to react, visually readable, and~     therefore enables women to test the cause of any unidentified wetness. An additional,~     secondary objective is to show that the AL-SENSE is associated with levels of sensitivity and~     specificity that are comparable to those specified for the currently marketed AMNIOTESTTM~     (nitrazine yellow swabs; PRO LAB Diagnostics) product.~   "
28769|NCT03190421|"~     This purpose of this study is to see if expanded urine culture techniques used in the~     laboratory improve the clinical care of women over standard urine culture techniques.~   "
28770|NCT03190408|"~     To conduct a multicenter observational cohort study to determine the variability in fluid~     resuscitation in shock in a broad range of areas in hospitals and treatment areas.~   "
28771|NCT03190395|"~     Atrial fibrillation (AF) is the most serious atrial electrical activity disorders, is also~     one of the common tachyarrhythmias.Circumferential pulmonary Vein Isolation (CPVI) is~     considered to be the cornerstone of paroxysmal atrial fibrillation ablation, but recently~     reported in the literature that pure CPVI treatment for paroxysmal atrial fibrillation the~     5-year success rate as low as 46.6%, and the incidence of atrial reentry tachycardia is also~     high in the follow-up period. Therefore it is necessary for us to explore whether the success~     rate of CPVI combined with Leftatrium Roofline Ablation (CPVI + LARA) for paroxysmal atrial~     fibrillation is higher than the pure CPVI.~   "
28772|NCT03190382|"~     The overall goal of SHOWME-PAD is to make the existing evidence-base on treatment outcomes~     -focusing on health status outcomes that reflect the patients' perspective - more~     transparently available to patients and providers, such that more informed, evidence-based~     shared treatment decisions occur. INTEGRITY-PAD has the potential to radically reorganize~     care delivery to patients with PAD such that more value for the patient and society will be~     created.~   "
28773|NCT03190369|"~     Primary Objective:~      -To evaluate the efficacy of a single 6-mL intra-articular (IA) injection of Hylan G-F 20~     measured by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numerical~     Rating Scale (NRS) 3.1 A1 score over a total period of 26 weeks in Chinese patients with~     symptomatic osteoarthritis (OA) of the knee.~      Secondary Objectives:~        -  To evaluate the response rate of a single 6-mL IA injection of Hylan G-F 20 in~          comparison to an IA placebo injection over 26 weeks. Response is defined as WOMAC A1 ≥2~          point improvement from baseline on NRS in daily pain score averaged over a 7-day period.~        -  To evaluate the safety of a single 6-mL IA injection of Hylan G-F 20, in comparison to~          an IA placebo injection over 26 weeks.~   "
28774|NCT03190356|"~     The purpose of this study is to show the effectiveness of Soberlink's remote alcohol~     monitoring system integrated with MAP's patient engagement platform (EHR) to monitor a sample~     size of at-risk alcohol use disorder (AUD) population. Ultimately, this data is leveraged to~     improve clinical outcomes and manage financial risk through facilitating early interventions~     and other means of mitigating recidivism and costly treatment episodes from AUD population.~   "
28775|NCT03190343|"~     The biliary and pancreatic tumors are rare but the prognosis is pejorative. It was difficult~     to have histology of these tumors as the samples taken during ERCP were performed under ~     blind  radiology control. So the diagnostic accuracy was insufficient.~      The arrival of A new optic fiber endoscope used by only one operator had improved the~     diagnostic of bilio-pancreatic diseases. However this technology with optic fiber quickly had~     proved outdated for several reasons: poor manoeuvrability, perfectible optical vision,~     optical fibers fragility and cost.~      A new generation of endoscopes with digital vision appeared and would allow an increase in~     diagnostic accuracy related to better vision and manoeuvrability.~      The purpose of the study is to assess the interest of the cholangio pancreatoscopy performed~     with digital vision.~   "
28776|NCT03190330|"~     The primary purpose of this study is to evaluate the post-marketing safety of ImbruvicaTM~     (ibrutinib capsule 140 milligram [mg]) under actual conditions of use, and to understand the~     incidence of adverse events (AEs) (serious and non-serious AEs).~   "
28777|NCT03190317|"~     This is a study of study of My HealtheVet (MHV) use by Veterans diagnosed with Human~     Immunodeficiency Virus (HIV) and VA providers/staff who care for them. We hope to learn and~     understand how MHV can improve the self-management of chronic conditions like HIV. First, we~     will review Veteran medical records to look at the relationship between use of MHV and~     whether it has a positive or negative impact on the Veteran's management of HIV. Next, we~     will interview Veterans to find out how they use MHV for self-management and both Veterans~     and providers to find out why they choose to use (or not to use) specific MHV tools. Lastly,~     we will use the information we found from the first two steps and create an intervention that~     will encourage non-MHV users to use the MHV tools that can help them achieve their~     health-related goals. Once the intervention has been developed, Veterans and providers will~     participate in a cognitive walkthrough where they will help the researchers test the~     intervention to see if it is usable, possible, and acceptable.~   "
28982|NCT03187639|"~     To determine whether, in a population of patients presenting to the rapid access chest pain~     clinic (RACPC), routine FFRct (Fractional Flow Reserve Computed Tomography) as a default test~     is superior in terms of resource utilisation when compared to routine clinical pathway~     algorithms recommended by the National Institute for Health and Care Excellence (NICE)~   "
28778|NCT03190304|"~     Studies with new drugs in the treatment of heart failure (HF), such as the combination of~     valsartan/sacubitril, also known as LCZ696, have demonstrated important clinical impact on~     the morbidity and mortality outcomes in HF population. However, the effect of LCZ696 on the~     pathophysiological mechanisms of HF such as exercise tolerance (peak VO2) and peripheral~     muscle blood flow is not known. Since LCZ696 is a new drug with promising effects on the~     treatment of HF, the objective of the present study will be to evaluate the effect of LCZ696~     in patients with HF on: 1) peak VO2, 2) 6-minute walk test, 3) peripheral muscle blood flow,~     4) muscle strength, and 5) body composition.~   "
28779|NCT03190278|"~     Phase I, first-in-human, open-label, dose-finding study of UCART123 administered~     intravenously to patients with Acute Myeloid Leukemia (AML), followed by a dose-escalation~     stage in Relapsed or Refractory AML patients and a dose expansion stage in~     Relapsed/Refractory AML patients, and in poor-prognosis, newly diagnosed AML patients in the~     European LeukemiaNet (ELN) Adverse genetic risk group.~   "
28780|NCT03190265|"~     The purpose of this study is to study the safety and clinical activity of nivolumab and~     ipilimumab in combination with either sequential administration of CY/GVAX pancreas vaccine~     followed by CRS-207 (Arm A) or with administration of CRS-207 alone (Arm B) in patients with~     pancreatic cancer.~   "
28781|NCT03190252|"~     Research hypothesis~        -  Diving to depths up to 90msw with an oxygen partial pressure of 130kPa in the breathing~          gas will affect the central nervous system.~        -  Diving to depths up to 90msw with an oxygen partial pressure of 130kPa in the breathing~          gas will induce inflammatory changes.~      Objectives:~        -  To investigate the presence of cerebrospinal biochemical markers in blood after diving~          to depths up to 90msw with an oxygen partial pressure of 130kPa in the breathing gas.~        -  To investigate the presence of inflammatory markers in blood after diving to depths up~          to 90msw with an oxygen partial pressure of 130kPa in the breathing gas.~        -  To investigate the presence of venous gas emboli (VGE) in blood after diving to depths~          up to 90msw with an oxygen partial pressure of 130kPa in the breathing gas.~   "
28782|NCT03190239|"~     Lung cancer is a malignant tumor that causes the highest morbidity and mortality, and the~     main pathological type is non-small cell lung cancer (NSCLC). Most of them present with~     advanced stage at diagnosis. This design is to study maintenance therapy with pemetrexed plus~     apatinib after first line induction therapy four cycles for advanced non-squamous~     non-small-cell lung cancer.~   "
28783|NCT03190226|"~     The aim of this study was to evaluate the potential of L-PRF in increasing the width of the~     keratinsed mucosa around implants. Furthermore, it was assessed whether this surgery was~     associated with significantly less post-operative discomfort for the patient compared to Free~     Gingival Graft surgery. L-PRF for increasing keratinised mucosa around implants.~   "
28784|NCT03190213|"~     This is an open label, non-randomized phase 2 study to assess overall response rate (ORR),~     clinical benefit rate (CBR), overall survival (OS) and progression free survival (PFS) in~     patients with high grade neuroendocrine tumors treated with pembrolizumab 200mg Q 3 Weeks.~   "
28785|NCT03190200|"~     The purpose of the study is to determine if by using MRI changes can be identified changes~     early on in the knees of young children that may be at risk for developing osteochondritis~     dissecans. If MRI can identify changes then better council can be offered about the risks of~     future activity and treatment options.~   "
28786|NCT03190187|"~     The aim of the present intervention study is to determine the effectiveness of manipulation~     techniques.~   "
28787|NCT03190174|"~     This study investigates the safety/toxicity and potential anti-tumor activity of sequential~     administration of nivolumab and escalating doses of the mTOR inhibitor ABI-009 in advanced~     UPS, LPS, CS, OS and Ewing sarcoma.~   "
28788|NCT03190161|"~     The purpose of this study is to explore the impact of self-selected music listening which~     targets disrupting the reward process maintaining smoking and additionally attenuating the~     reward processing deficits associated with schizophrenia. Five participants with~     schizophrenia/schizoaffective disorder who smoke/nicotine will participate in an individual~     session of self-selected music listening for a half an hour.~   "
28789|NCT03190148|"~     In this study glucose metabolism of pregnant women with a history of bariatric surgery, obese~     pregnant women and normal weight pregnant women was investigated. Three to six months after~     delivery the assessment of Glucose metabolism was repeated and the amount of ectopic lipids~     in the liver, heart and muscle was measured.~   "
28790|NCT03190135|"~     BOKS, Build Our Kids' Success, is a before-school physical activity program that has been~     implemented in over 2,000 elementary and middle schools. Students participate in the program~     for 12 weeks, two or three mornings per week for about 1 hour per session. This study if a~     non-randomized control trial seeking to 1) examine the extent to which participation in the~     before-school BOKS program improves, health, well-being, and performance, and 2) compare the~     results of a two-day-per-week versus a three-day-per-week program.~   "
28791|NCT03190122|"~     Neurocognitive Outcome Assesment in Patients With Peri-optic Meningiomas After Excision With~     Or Without Pealing Of The Outer Layer Of The Cavernous Sinus: A Randomized Controlled Single~     Blinded Trial.~   "
28792|NCT03190109|"~     Aiming to validate the use of bone age determined by ultrasound (BAUS) in Brazilian children,~     normal control students will be studied. X-Ray bone age (RXBA) and BAUS will be determined in~     500 children and adolescents of both genders, with chronological age varying from 6-16 years.~      Concordance analysis and the correlation between both BA determination methods will be~     performed.~   "
28793|NCT03190096|"~     The present study is designed as a observational prospective, multicentre, international. The~     main aim of this study is to evaluate the safety and feasibility of SVC isolation with the CB~     in a prospective manner.~   "
28794|NCT03190083|"~     The purpose of this study is to determine if a 3-dimensional mammogram (DBT) may provide~     additional information to evaluate the extent of disease and additional findings that would~     aid in staging a new breast cancer patient. This would impact surgical planning and improve~     patient outcomes.~   "
28795|NCT03190070|"~     Single arm physiological study to measure renal functional reserve as a biomarker of kidney~     function and health~   "
28796|NCT03190057|"~     The objective of this study is to evaluate effectiveness and safety of BioFreedom stent in~     the real world daily practice as compared with other drug-eluting stents.~   "
28797|NCT03190044|"~     Migraine is a highly disabling disorder that affects hundreds of millions of people around~     the world. Yet, a little number of prophylactic treatments are available still now. The~     limited number of available drugs leads to a wide use of nutraceutical compounds in migraine~     therapy. To improve the efficacy, some of these nutraceuticals were combined. So far, we do~     not know if these combinations are really more effective than the single compounds alone, or~     an anti-synergic effect could be present because of a reciprocal antagonism of effects. For~     this reason, we decided to test the efficacy of a fixed combination of magnesium, partenium,~     andrographis, co-enzyme Q10 and riboflavin (PACR) as prophylactic treatment for migraine in a~     randomized controlled double blind study.~   "
28798|NCT03190031|"~     The present study aims at evaluating the effect of respiratory muscle training in adult~     patients with cystic fibrosis on lung function, exercise performance and quality of life.~   "
28799|NCT03190018|"~     The study is a proof-of-concept of peritoneal dialysis with the Carry Life System for~     Peritoneal Dialysis (CLS PD). The extra-corporeally absorption of uremic toxins and certain~     ions from the recirculated peritoneal fluid by the Purcart are evaluated together with the~     achievement of a stable intraperitoneal osmolarity.~   "
28800|NCT03190005|"~     The investigators designed the following experiment to observe the pattern of administration~     in vitro, which can be completely excluded liver enzyme cytochrome P450 metabolism under the~     influence and observe the relevant P2Y12 receptor downstream signal changes, hope in the~     above experiments, that the human body directly for the difference between the existence of~     drug reactions exist.~   "
28801|NCT03189992|"~     Traditional Chinese medicine (TCM) syndrome is a core foundation of disease knowledge,~     clinical diagnosis and treatment and curative effect evaluation in TCM. Same TCM Syndrome~     for Different Diseases and Same Treatment for Different Diseases is one of the~     characteristics of TCM syndrome differentiation and treatment.~      This study is the TCM disease syndrome combination research baced on principles and methods~     of system biology, which is through acquisition of primary hepatocellular carcinoma (HCC) and~     colorectal cancer patients with TCM syndrome information, detection of clinical indicators~     and genomic, proteomic, and metabolites changes, analyzing the correlation between TCM~     syndromes and biological information, and revealing its biological material characteristics~     and the molecular mechanisms of Same TCM Syndrome for Different Diseases;Developing and~     implementing the program of TCM syndrome differentiation and treatment for HCC and colorectal~     cancer to evaluate the efficacy of TCM syndrome based-treatment of HCC and colorectal cancer~     with TCM syndrom scores, clinical and systems biological indicators, quality of life and~     survival rate, and to revealing the mechanism of the Same Treatment for Different Diseases.~   "
28802|NCT03189979|"~     Background: Youth from low-income and minority families are disproportionately affected by~     obesity and its complications. This study presented pilot work to develop and implement a~     multi-component physical activity and healthy eating intervention at a Boys & Girls Club~     (BGC) after school program.~      Methods: Using a community-based participatory approach, BGC staff and academic researchers~     developed intervention components informed by formative studies and based on a social~     ecological theory framework. Components included healthy eating and physical activity policy~     implementation, staff training, a challenge/self-monitoring program for healthy behaviors, a~     peer-coaching program for healthy behaviors, and a social marketing campaign. Preliminary~     intervention efficacy was assessed through a single group, pre-post study design with~     measured collected at baseline and 6 months.~   "
28803|NCT03189966|"~     The aim of the study is to evaluate the effectiveness of ultrasound-guided transversalis~     fascia plane block (TFPB) and quadratus lumborum block (QLB) on post-operative analgesia in~     pediatric patients with Developmental Dysplasia of the Hip (DDH)under going open reduction~     surgeries（Salter acetabular osteotomy，combined with proximal femoral rotation osteotomy）.The~     effectiveness of TFPB/QLB for perioperative analgesia in lumbar nerves (L1) innervated~     surgery have been demonstrated in recent studies. However, this regional technique rarely~     applied to children.The objective of our research is to assess the quality of postoperative~     analgesia in pediatric patients who had received a preoperative TFPB/QLB for hip surgery.~   "
28804|NCT03189953|"~     In order to improve the sensitivity and specificity of pre-operative imaging localization of~     foci in adult endogenous hyperinsulinemic hypoglycaemia (AHH) we aim to evaluate a novel~     promising imaging compound targeting the glucagon-like peptide-1 receptor (GLP-1R),~     68Ga-NODAGA-exendin 4. With the currently used imaging techniques, only about 70-80% of~     insulin producing pancreatic neuroendocrine tumors (IPPNET) can be successfully visualized.~     Therefore, we propose to compare GLP-1R PET imaging to the standard imaging techniques in~     patients scheduled for surgical removal of the tumour. These highly relevant data will allow~     us to interpret the benefits of GLP-1R-imaging over other imaging techniques for the~     diagnosis of IPPNET in AHH patients. Since pre-operative localization of foci in AHH remains~     challenging and frequently still leading to futile surgery or unnecessary partial~     pancreatectomy, a more sensitive and specific imaging technique would be of great value.~   "
28805|NCT03189940|"~     This study aimed to investigate the effects of a mobile phone app linked to hospital~     electronic medical record (EMR) system on weight reduction and obstructive sleep apnea (OSA).~     Adults aged > 20 years with witnessed snoring or sleep apnea from a sleep clinic of a~     tertiary center were prospectively enrolled, and the participats were randomized into app~     user and control groups. The mobile app was designed to collect daily lifestyle data by~     wearing a wrist activity tracker and reporting dietary intake. At the visit after 2 weeks of~     use, a summary of the lifestyle was displayed on the hospital EMR and reviewed by both~     physicians and app users. Further lifestyle modification was encouraged on the basis of the~     electronically collected data. In the control group, the lifestyle modification performed as~     the usual practice. All participants underwent Watch PAT and body mass index (BMI)~     measurement twice: on enrollment; and after 4-weeks follow up. Changes of BMI, and parameters~     of sleep related breathing were analyzed.~   "
28806|NCT03189927|"~     A non-randomized prospective clinical, pilot study in a single centre assessing the safety~     and feasibility of the esophageal biodegradable covered stent for refractory benign~     esophageal strictures with or without fistulae~   "
28983|NCT03187626|"~     The primary purpose of this study is to determine whether a single ultrasound-guided~     intra-articular injection of botulinum toxin A associated to splinting is effective in~     reducing pain at 3 months in base-of-thumb osteoarthritis.~   "
28808|NCT03189901|"~     There are always poor outcomes in patients with acute myocardial infarction(AMI) combined~     with elevated BNP/NT-proBNP level. An elevated BNP/NT-proBNP level highly indicates acute~     heart failure(AHF).Levosimendan is recommended in many clinical trials of heart failure and~     Chinese heart failure guidelines. As a result, the investigators form a hypothesis that when~     patients with AMI combined with elevated BNP/NT-proBNP level are in conditions before AHF, to~     use levosimendan may reduces the risk of heart failure and improve the outcome.~   "
28809|NCT03189888|"~     BACKGROUND: Granulocyte-monocyte apheresis has been proposed for the treatment of ulcerative~     colitis, although is limited by costs and variability of results.~   "
28810|NCT03189875|"~     SPOCS is an international, multicenter, prospective observational cohort study with bi-annual~     study visits over a 3-year follow-up designed to systematically describe the comprehensive~     SLE patient-journey regarding clinical features, disease progression and treatment patterns,~     SLE outcomes, health status assessments (PROs), and health care resource utilization (HCRU)~     in a general population of moderate-to-severe SLE patients.~   "
28811|NCT03189862|"~     Physical inactivity in children is a major public health risk factor and a health objective~     for the nation. This study aims to investigate the short- and long-term effects of a movement~     and physical activity program - the Children Health and Motor Programs (CHAMP) on motor~     competence, perceived motor competence, and physical activity. A secondary aim of this~     project (i.e., Science of Behavior Change Administrative Supplement) is to examine the~     immediate (pre- to post-test) effects of the CHAMP intervention on self-regulation and~     associations between self-regulation and changes in motor competence, perceived motor~     competence, and physical activity. The long term goal is to provide evidence-based movement~     experiences during the early childhood years that promote and contribute to overall healthy~     growth and development.~   "
28812|NCT03189849|"~     This study will be an observational study of children who attend summer camp at the Heartland~     Farm Sanctuary (HFS). The investigators are exploring whether time-limited exposure to a~     traditional farming environment will improve children's overall health and general~     well-being.~   "
28813|NCT03189836|"~     This is a phase 1, multi-center, single-arm, open-label study evaluating the safety and~     anti-lymphoma activity of an autologous T cell product (ACTR707) in combination with~     rituximab in subjects with refractory or relapsed CD20+ B cell lymphoma.~   "
28814|NCT03189823|"~     In order to create insights in the effects of Motor cortex stimulation (MCS) on intractable~     pain, an open observational study was started in 2003. The aim of this research is to:~        1. to determine the clinical effectivity of MCS on pain intensity after 1 month, 1 year and~          3 years of stimulation~        2. to determine the clinical effectivity of MCS on QoL and daity medication intake after 3~          years of MCS~   "
28815|NCT03189810|"~     The high prevalence of cannabis and other substance use disorders are a major barrier to~     recovery in people with schizophrenia. Moreover, schizophrenia patients have significant~     deficits in cognitive function, which may be exacerbated by cannabis use. Complicating these~     problems is the lack of evidence-based treatments for co-morbid cannabis use disorders (CUDs)~     in schizophrenia; there are no established pharmacotherapies. Therefore, this study is~     investigating the effects of high-frequency (20Hz) repetitive transcranial magnetic~     stimulation (rTMS) on cannabis use disorder and cognitive function in patients with co-morbid~     schizophrenia/schizoaffective disorder. The proposed study would be the first randomized,~     double-blind, sham controlled trial of rTMS in patients with schizophrenia and co-morbid CUD.~     A total of N=40 schizophrenia smokers with co-morbid cannabis use disorder will be assigned~     to either active rTMS (N=20) or sham rTMS (N=20) as a treatment regimen of 5X/week treatment~     for four consecutive weeks. All participants will receive weekly behavioral therapy for 4~     weeks. The investigators predict that active rTMS will be well-tolerated and superior to sham~     rTMS for the treatment of CUD in schizophrenia.~   "
28816|NCT03189797|"~     This study will be conducted to evaluate The Effect of tailored preventive program on caries~     incidence using International Caries Classification and Management System (ICCMS) at a follow~     up periods of 3 and 6 months.~   "
28817|NCT03189784|"~     Ankle joint self mobilization.~   "
28818|NCT03189771|"~     effect of occlusal reduction on post-operative pain is evaluated after single visit root~     canal treatment in upper and lower molar teeth in patients with sypmtomatic irreversible~     pulpitis and apical periondontis~   "
28819|NCT03189758|"~     Sodium-adapted magnetic resonance imaging (23Na-MRI) studies have demonstrated that sodium~     accumulates in certain tissues, including the skin and skeletal muscle, but may be~     manipulated by lifestyle factors or therapeutic interventions such as a hemodialysis (HD)~     session. This tissue sodium accumulation is increased with age and in the presence of certain~     chronic diseases such as renal failure, and may contribute to the development of high blood~     pressure. It currently not known what the impact of dietary sodium consumption has on tissue~     sodium in HD patient's and on the subsequent risk of cardiovascular complications either~     acutely or chronically. The University of Illinois' Biomedical Imaging Center recently~     completed safety testing on a 23Na-MRI coil that they modified for measuring skin and muscle~     sodium levels in the lower leg/calf that will be used for assessing the impact of dietary~     salt restriction on tissue sodium levels.~   "
28820|NCT03189745|"~     This study will evaluate the immunogenicity, reactogenicity and safety of a booster dose of~     MenACWY-TT vaccine administered 10 years after healthy subjects aged 11-17 years received~     either MenACWY-TT vaccine (Nimenrix) or Mencevax ACWY~   "
28821|NCT03189732|"~     The aim of this study is to investigate whether metformin has inhibitory effect on~     exercise-induced lipolysis in subcutaneous adipose tissue in healthy lean man. Ten healthy~     lean mean will follow protocols consisting of 60 minutes of exercise on bicycle ergometer~     combined with a) orally administered metformin and b) locally administered metformin into~     adipose tissue and c) without metformin treatment. Microdialysis is used for assessment of~     metabolites in situ in subcutaneous adipose tissue.~   "
28839|NCT03189498|"~     The primary purpose of this study is to evaluate the pharmacokinetic (PK) and systemic~     exposure of JNJ-63549109 and JNJ-64167896 after a single oral dose of JNJ-64041575 in adult~     participants with various degrees of renal function (mildly, moderately, or severely~     impaired, or end-stage renal disease [ESRD] with or without hemodialysis) compared to adult~     participants with normal renal function.~   "
28822|NCT03189719|"~     The purpose of this trial is to evaluate efficacy and safety of pembrolizumab plus cisplatin~     and 5-fluorouracil (5-FU) chemotherapy versus placebo plus cisplatin and 5-FU chemotherapy as~     first-line treatment in participants with locally advanced or metastatic esophageal~     carcinoma.~      The primary efficacy hypotheses are that both progression-free survival (PFS), according to~     Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and determined by blinded~     independent central review, and overall survival (OS) are superior with pembrolizumab plus~     chemotherapy compared with placebo plus chemotherapy in all participants as well as~     participants whose tumors are programmed cell death-ligand 1 (PD-L1)-positive.~   "
28823|NCT03189706|"~     The purpose of this study is to find out whether an experimental drug called Hu3F8 can be~     given with the chemotherapy drugs irinotecan and temozolomide and another drug called GM-CSF.~     The investigators want to find out if this combination is safe and what effect it has on the~     participant and the disease.~   "
28824|NCT03189693|"~     Paravertebral Block (PVB) was shown to be a successful and useful technique of anesthesia and~     analgesia. Its effect was evident in thoracic and abdominal surgeries. In the setting of~     appendectomy, somatic PVB has been used for pediatric patients. It was shown to decrease~     opioid consumption and provide prolonged pain relief. Hence, it would be beneficial to~     examine the analgesic effect of PVB on appendectomy in adult patients.~   "
28825|NCT03189680|"~     To determine the effects of an unusually highly intensity and individualized sensorimotor and~     visuomotor agility exercise program on non-demented PD patients' clinical symptoms, mobility,~     and postural stability.~   "
28826|NCT03189667|"~     Compare the effectiveness of drug-coated balloons to plain balloon angioplasty in reducing~     stenosis rates in dialysis arteriovenous fistulas (AVFs).~   "
28827|NCT03189654|"~     There are no investigations so far whether an application of positive pressure during~     non-invasive ventilation might be a therapeutic option for transudative pleural effusion in~     patients with heart failure. In view of the pathophysiological process with pleural effusion~     resulting from an increase in intravascular hydrostatic pressure, non-invasive ventilation~     might provide an improvement.~      The aim of the present study is to investigate whether an additional non-invasive ventilation~     therapy leads to an improved suppression of pleural effusion in heart failure patients.~   "
28828|NCT03189641|"~     The purpose of the this trial is to evaluate the clinical safety and efficacy of Cilostazol~     eluting stent system (CES-1) for the treatment of single de novo lesions in native coronary~     arteries.~   "
28829|NCT03189628|"~     The purpose of this study is to observe whether the transplantation of autologous stromal~     vascular fraction (SVF) in adipose tissue is safe and its effect on improving skin~     regeneration.~   "
28830|NCT03189615|"~     The purpose of this study is to assess the impact of mild to moderate hepatic impairment on~     the pharmacokinetics of a single oral dose of Lu AF35700~   "
28831|NCT03189602|"~     The purpose of this study is to analyze the clinical manifestations, imaging features, and~     prognosis-related factors of pulmonary artery (PA) involvement in Takayasu's arteritis (TA),~     and to explore the early clinical features of PA involvement in TA patients.~   "
28832|NCT03189589|"~     GSK2269557 is being developed as an anti-inflammatory and anti-infective agent for the~     treatment of inflammatory airways diseases. This is the first study using a new formulation~     of GSK2269557 in healthy subjects and will evaluate the safety, tolerability and PK of a~     single dose of GSK2269557. Data derived from this study will inform on the PK profile and~     systemic exposure expected during Phase 2b. Approximately twelve healthy subjects will be~     randomized to receive a single dose of GSK2269557 750 micrograms (µg) or a single dose of~     GSK2269557 500 µg via the ELLIPTA® dry powder inhaler (DPI) formulated in a blend containing~     0.4 percent magnesium stearate (MgSt) in 1:1 ratio. This randomized, parallel group study~     will be carried out in 3 phases, including screening phase, treatment phase and follow-up~     phase. The total study duration for each subject will be up to 6 weeks. ELLIPTA is a~     registered trademark of GlaxoSmithKline group of companies.~   "
28833|NCT03189576|"~     Circulating tumour DNA (ctDNA) is a promising tool when monitoring the residual disease in~     colorectal cancer (CRC). Current staging procedures are insufficient to identify the patient~     cohort at high risk, who might benefit from additional adjuvant therapy.~      We will show that the assessment of ctDNA is a non-invasive approach and easily taken at~     different time points via simple blood draw to monitor residual disease from the colorectal~     cancer patients after primary surgery. Minimal residual disease could be used in the future~     for individualized treatment decisions after primary surgery.~   "
28834|NCT03189563|"~     This is a phase IIa, first in human, randomized, double-blind, multicenter study to evaluate~     the safety, tolerability and efficacy of DA-9805 at 45mg, 90mg versus placebo in subjects~     diagnosed with early Parkinson's disease.~   "
28835|NCT03189550|"~     Multimodal perioperative care pathways have evolved into enhanced recovery after surgery~     (ERAS). ERAS pathways improve the quality of patient care, reduce morbidity, and shorten~     length of stay. This project will test the hypothesis that implementation of a multi-modal~     ERAS perioperative care protocol in colorectal surgical patients will result in significantly~     reduced perioperative morbidity and mortality.~   "
28836|NCT03189537|"~     The purpose of the study was to evaluate efficacy of prophylactic Ingavirin intake by people~     having contact with sick people infected with influenza and other acute respiratory viral~     infections~   "
28837|NCT03189524|"~     This phase I clinical study is to investigate the safety, tolerability and pharmacokinetics/~     pharmacodynamics of BTK inhibitor BGB-3111 in Chinese patients with B-cell lymphoma, by~     conducting in two stages, the first stage being the safety assessment of dose, and the second~     stage being the dose expansion.~      Part I: Safety evaluation - according to the results of preclinical toxicological trials and~     the results of the phase I clinical study conducted in Australia and New Zealand, two~     regimens of BGB-3111 320 mg daily (160 mg BID, administered in the morning and at night, or~     320 mg QD) and 3+3 design is adopted for the assessment. The recommended dose and method of~     administration of phase II clinical study will be determined according to the Part I results.~      Part II: Dose expansion - this stage is to further evaluate the preliminary anti-tumor~     effects of BGB-3111 in Chinese subjects with follicular lymphoma (FL) or marginal zone~     lymphoma (MZL), approximately 20 subjects with relapsed or refractory follicular lymphoma~     (FL) or marginal zone lymphoma (MZL) will be enrolled. The recommended Phase 2 dose will be~     used in the Part II.~   "
28840|NCT03189485|"~     The purpose of this study is to measure the amount of a protein in the brain known as tau~     using an imaging procedure called Positron Emission Tomography (PET/CT). 18F-AV-1451 is a~     specialized radioactive PET imaging agent that is able to detect the presence of tau in the~     brain. In this study, the investigator will use the 18F-AV-1451 to capture images of tau in~     the brain. Findings from this study will likely provide insight into the mechanisms and~     distinctions of age-related cognitive decline and that of very early Alzheimer's disease.~   "
28841|NCT03189472|"~     This is a double-blind randomized controlled pilot study to test the effects of~     Remotely-Supervised (RS)-tDCS using a dorsolateral prefrontal cortex montage to ameliorate~     fatigue and cognitive slowing in PD.~      Fatigue and slowed thinking are very prevalent symptoms in people with Parkinson's disease~     (PD). To date there are no concrete effective treatment available for either symptom. This~     study will test transcranial direct current stimulation (tDCS) to ameliorate fatigue and~     slowed thinking in PD. tDCS is a noninvasive brain stimulation technique that is low-cost,~     relatively safe, and reproducible when conducted in repeat clinic visits.~      Following procedures for our validated protocol, participants will receive training on the~     use of study tDCS device and pre configured laptop computer. The device will be programmed to~     deliver either active or sham tDCS (all study personnel and participants will be blinded),~     and operated with unlock codes provided by the study technician daily to release one session.~     Once trained, and following an initial in-clinic baseline tDCS tolerability test and initial~     treatment session, participants will use the equipment to complete the remaining sessions~     from their home using our tele medicine platform. Remote supervision will be provided using~     HIPAA secure online video conference with the study technician following clearly-defined~     operational procedures. Participants will be monitored to determine if any predefined stop~     criteria are met using VSee software, a telemedicine software. Additionally, Team Viewer~     software will allow study technicians to troubleshoot any computer issues, to initiate the~     video conference on behalf of participants, and to remotely supervise the entire tDCS~     session.~   "
28842|NCT03189459|"~     Advanced Parkinson's Disease is a debilitating, costly, and understudied condition. Improving~     access to comprehensive, specialized, in-home patient care and caregiver support offers the~     potential to minimize the downward spiral of morbidity and preventable healthcare~     utilization. The aim of this study is to test whether and to what degree an interdisciplinary~     home visit program, with and without peer mentoring for caregivers, will improve patient- and~     caregiver-reported outcomes and reduce healthcare costs when compared with usual care in~     advanced Parkinson's Disease.~   "
28843|NCT03189446|"~     The purpose of this study is to determine the progression-free survival of patients with~     surgically staged, Stage I-II papillary serous, clear cell, or endometrioid carcinomas with~     high-intermediate risk factors treated by vaginal cuff brachytherapy followed by~     chemotherapy.~   "
28844|NCT03189433|"~     Ryanodex is being investigated as a potential adjuvant treatment for people suffering from~     psychostimulant drug-induced toxicity (PDIT), a life-threatening medical condition that~     results mainly from the abuse of certain illicit drugs, most notably methamphetamine, and~     related forms (MDMC or Molly; MDMA or Ecstasy). Ryanodex is approved for the treatment of~     malignant hyperthermia in conjunction with appropriate supportive measures and for prevention~     of malignant hyperthermia in patients at high risk and in this study, will be investigated~     for the treatment of PDIT. The hypothesis of this study is that administration of Ryanodex as~     adjuvant treatment to Standard of Care (SOC) will improve the clinical outcome compared with~     SOC alone, in subjects with psychostimulant drug induced toxicity. Current SOC is defined as~     body cooling and supportive measures.~   "
28845|NCT03189420|"~     Diffuse glioms are primary brain tumors characterized by infiltrative growth and high~     heterogeneity, which render the disease mostly incurable. Advances in genetic analysis~     revealed that molecular and epigenetic alterations predict patients´s overall survival and~     clinical outcome. However, glioma tumorigenicity is not exclusively caused by its genetic~     alterations. The crosstalk between tumor cells and the surrounding microenvironment plays a~     crucial role in modulating glioma growth and aggressiveness. In this sense, to understand the~     tumor microenvironment would elucidate potential treatment alternatives. The focus will be to~     evaluate myeloid cells and cytokines levels.~   "
28846|NCT03189407|"~     Type 2 diabetes mellitus (T2DM) patients from our previous survey tend to co-administer~     various herbs with their oral hypoglycemic agents (OHA). Some of these herbs are known to~     possess antidiabetic activities. One of such is Moringa oleifera leaves.~      The present study evaluated the effects of seven days, twice-daily administration of hot~     water infusion of dried Moringa oleifera leaves on the steady state plasma concentrations of~     Metformin, one of the most widely used OHAs using T2DM patients who have been on Metformin~     for a period of not less than three months. The included patients had also been on Moringa~     supplementation but had terminated the use of Moringa at least a month to the start of the~     study.~      Patients who had other comorbidities such as heart diseases, renal or hepatic impairments~     were excluded from the study. The patients were recruited from Endocriniology clinic of the~     Obafemi Awolowo University Teaching Hospitals complex, a tertiary hospital from southwest~     Nigeria.~      Each patient served as his/her control.~   "
28847|NCT03189394|"~     The proposed study is a randomized controlled intervention to reduce sexual risk for HIV~     among HIV-negative concordant and HIV discordant gay couples. There are three arms of the~     study: 1) the in-person experimental condition, PRIDE, 2) the online adaptation of the~     experimental condition, ePRIDE, and 3) the time- and attention-matched in-person control~     condition, Men's Health. Participants (N = 300 couples) will be randomized equally into one~     of the three study conditions and assessed via surveys at baseline and at 3-, 6- and 9-months~     after completion of the intervention sessions.~   "
28909|NCT03188588|"~     Long-term oxygen therapy (LTOT) is the reference treatment for chronic respiratory failure.~     This treatment is based on the principle of oxygen supplementation via a source to correct~     hypoxemia in patients. At present, adherence to this treatment is difficult to evaluate~     (reporting by patients), but the results of the literature show poor LTOT compliance. It is~     therefore important to accurately measure the oxygen consumption by patients and to~     understand the factors explaining LTOT compliance. The ultimate aim is to improve our patient~     management to make them more observant in order to improve the therapeutic efficacy of the~     treatment.~   "
28848|NCT03189381|"~     This trial is a pilot, Phase 2, sequential two-cohort study designed to test two de-escalated~     whole brain radiation therapy (WBRT) dose levels and assess their ability to maintain~     acceptable in-brain distant control. The WBRT dose would decrease as the study moves forward,~     both in terms of absolute value and equivalent dose in 2 Gray fractions (EQD2) (as determined~     by the linear quadratic radiobiological model). The absolute value of the simultaneous~     integrated boost (SIB) dose will change with each dose level because the number of fractions~     delivered will depend on the WBRT dose. As such, the SIB dose will be manipulated such that~     the EQD2 will remain essentially equivalent despite the difference in the number of fractions~     delivered. This design will ensure that the only variable is the change in WBRT dose.~      The concept is that WBRT with SIB would be expected to maximize both local and in-brain~     distant control as has already been shown in studies exploring WBRT with SRS boost. However,~     by itself WBRT with SIB does not address the concern over neurocognitive outcomes. Therefore,~     investigators hypothesize that there is a lower WBRT dose threshold that will maintain~     acceptable in-brain distant control, particularly in the setting of a SIB to gross lesions to~     maintain treated lesion control. In addition, lower overall brain dose (including lower~     hippocampal dose without specific hippocampal avoidance) may potentially improve~     neurocognitive function. Investigators are also interested in evaluating treated lesion~     control, overall survival, neurocognitive sequelae of therapy, quality of life, performance~     status, and adverse effects of therapy. Biomarker identification for potential correlative~     circulating tumor DNA and microRNA is an exploratory endpoint to generate data for future~     prospective evaluation.~   "
28849|NCT03189368|"~     To perform a comparative study of multi-site left ventricular pacing and cardiac~     resynchronization therapy effects on ventriculoarterial coupling and energy efficiency of the~     failing heart~   "
28850|NCT03189355|"~     With a prevalence of more than 15% in ICU, septic shock today represents a real public health~     problem and remains the leading cause of mortality in ICU. Undernutrition is characterized by~     an alteration of the body composition and in particular by a loss of muscle mass. In~     intensive care, there are indirect elements suggesting a link between loss of muscle mass and~     prognosis.~      Muscle mass results from a balance between the pathway of proteolysis and that of protein~     synthesis, depending on many factors, not one of the most important are insulin. The protein~     PTP1B (Protein Tyrosine Phosphatase 1B), by the dephosphorylation of its numerous substrates,~     constitutes an endogenous regulator of numerous intracellular signaling pathways, including~     that of insulin. PTP1B could play a role in the protein synthesis abnormalities observed~     during sepsis leading clinically to impaired body composition including muscle body mass.~     Therefore, we propose to study the association between PTP1B and loss of muscle mass in~     patients in sepsis in resuscitation.~      The intestinal barrier plays an essential role in protecting against microbial luminal flora~     and the phenomenon of bacterial translocation. Zonulin is one of the major regulators of~     tight junctions, important actors in the intestinal barrier function. The increase in plasma~     zonulin levels, greater than 0.6 ng / mg, is directly correlated with increased intestinal~     permeability (16). However, elevation of plasma zonulin has never been evaluated in septic~     resuscitation patients. This is why we propose the evaluation of the association between~     plasma zonulin and the loss of muscle mass in these resuscitation patients.~   "
28851|NCT03189342|"~     Dual task training has been shown to reduce the risk of falls more than single task training.~     However, there have been no studies which compared the effects of single task training, dual~     task training and asynchronous cognitive, balance exercise training during same day on the~     risk of falls among healthy older individuals. Therefore, the aim of this study was to~     investigate differences among the effects of single task training, dual task training and~     exercise-cognitive activity combined training on balance and gait performances and fall risk~     in elderly at risk of fall.~   "
28852|NCT03189329|"~     The investigators measured changes in cerebral oxygen saturation (rSO2) and MMSE scores after~     retrobulbar block performed with levobupivacaine and lidocaine in patients undergoing~     vitreoretinal surgery.A total of 66 patients over the age of 60 undergoing vitreoretinal~     surgery with a total duration of less than 1 hour were included in this prospective,~     double-blinded study. The patients were randomly divided into two groups: group L (5ml, 2%~     lidocaine) and group LB (5ml, 0.5% levobupivacaine). Bilateral rSO2 measurements were~     recorded before the retrobulbar block and at 1-5 minutes post-block, during the procedure,~     and at 10-40 minutes post-op. MMSE was performed preoperatively and postoperatively in order~     to evaluate short term cognitive function. Sensory and motor block durations, pain, akinesia~     and conjunctival feeling scores, patient-surgeon satisfaction, and complications were also~     recorded.~   "
28853|NCT03189316|"~     Some subsets of lymphocytes are able to inhibit immune response and thus, could be used to~     control auto-immune diseases and transplant reject. In mice, the main source of those~     anti-inflammatory lymphocytes is the peritoneal cavity. No data are available in human. This~     study aims at exploring the presence of those anti-inflammatory lymphocytes in human~     peritoneal cavity and at determine how to expand those cells.~   "
28854|NCT03189303|"~     Prospective, global, multicenter study to assess cup position in THA. After written informed~     consent has been obtained, study evaluations will be collected from the pre-op clinic visit,~     the operative visit (including discharge), and 6, 12 and 52 weeks postoperatively.~   "
28855|NCT03189290|"~     The purpose of this prospective research study is to determine the best way to manage~     post-operative pain after a total hip arthroplasty. Currently, there is no standard of care~     for managing post-operative pain in these patients. The quadratus lumborum block (QLB) first~     described by Blanco in 2007, is a promising technique in this indication: recently, there is~     a growing evidence for the use of the QLB as an alternative technique for pain management~     after hip surgery.~   "
28856|NCT03189277|"~     This cross-sectional study, utilizing two sets of questionaire designed for patients and~     physicians respectively, aims at the epidemiology, the clinical features, and the current~     status of evaluation and management of lung cancer related pain in 20 participating hospitals~     in Northern China.~   "
28942|NCT03188159|"~     This is a phase II study in patients with recurrent platinum resistant or refractory C5~     high-grade serous, endometrioid or undifferentiated ovarian, primary peritoneal or fallopian~     tube cancer. All patients with high-grade serous, endometrioid or undifferentiated primary~     peritoneum, fallopian tube or ovarian cancer will be eligible to be screened for this trial~     and will be required to sign a pre-screening consent form.~   "
28857|NCT03189264|"~     Percutaneous nephrolithotomy (PCNL) is a minimally invasive procedure considered as the~     treatment of choice for the management of large-scale and fully-formed kidney stones.This~     procedure has a 5% risk of complications including bleeding, the lesion of the collecting~     system, the risk of urinary infection and bacteremia. New surgical tools such as dilatation~     of the nephrostomy tract with mechanical dilatation contribute to the reduction of these~     risks, together with an improvement in the operative times and a lower rate of complications.~      At present there are multiple scales measuring the lithiasic morphology (Guy, the STONE~     nephrolitometry score system and the nomogram of the Office of Clinical Investigation of the~     Endourology Society - CROES) which allow to evaluate the degree of complexity of the stone,~     the possibility of residual stones and the risk of complications. These tools allow us to do~     a better analysis of the risk factors of the patient who will be taken to this type of~     endoscopic procedure in order to decrease morbidity and complication rates.~      Hypothesis:~      The use of pneumatic dilators during percutaneous nephrolithotomy reduces the rates of~     intraoperative and postoperative complications, which would have an impact on hospitalization~     times and surgical success for the management of renal stone.~   "
28858|NCT03189251|"~     Perform an exploratory analysis of association between consumption of high excess free~     fructose (EFF) beverages (high fructose corn syrup sweetened soft drinks, fruit drinks, apple~     juice) and Chronic Bronchitis (CB)/history of CB, and asthma/ history of asthma.~   "
28859|NCT03189238|"~     Female Orgasmic Disorder (FOD) is defined as a female sexual disorder with the presence of~     the following on all or almost all (75%-100%) occasions of sexual activity:~        1. Marked delay in, marked infrequency of, or absence of orgasm~        2. Marked reduced intensity of orgasmic sensations.~        3. The absence of orgasm must cause personal distress (bother) in order for these symptoms~          to be considered a disorder. (for example, women who are not very bothered by their lack~          of orgasm do not have FOD).~      Symptoms must have been present for at least 6 months and are not better explained by a~     mental disorder or because of a relationship problems or other significant stress in the~     participant's life and not due to effects of substance abuse or new medications or other~     medical conditions.~      Approximately one in twenty women have FOD and it is the second most frequently reported~     sexual problem in American women. FOD can either be lifelong (primary) or acquired~     (secondary).~      There are no currently FDA approved treatments or devices for FOD. Therefore, common~     off-label treatments include psychotherapy/sex therapy, hormone therapy, and medications that~     increase blood flow to the genitals.~      Platelet-rich plasma (PRP) is a platelet concentrate that may help to speed up tissue~     healing, without serious side effects, in some medical conditions. It has been tried as~     treatment for diabetic foot ulcers, muscle injury, tendon injury, and in a variety of~     cosmetic procedures. The only condition for which there are high-quality data and clear~     demonstration of effectiveness is arthritis of the knee. It is also apparent from the~     majority of published studies that PRP therapy has minimal risk of scar tissue formation or~     significant bad side effects.~      It has been suggested by many scientists that in some women FOD may be caused by decreased~     clitoral and genital blood flow secondary to blockage in the small blood vessels going to the~     clitoris (similar to that seen in erectile dysfunction (ED) in men) and/or diminished nerve~     conduction (also as seen in ED). PRP activates cells to develop into new tissue—nerves,~     collagen, and blood vessels. As such, PRP may potentially reverse the changes responsible for~     FOD. In addition, it has been shown that improved sexual function in women is highly linked~     with increased blood flow through the clitoris. One component of PRP is known to cause growth~     of new blood vessels. Therefore, the investigators anticipate PRP injections may potentially~     improve blood flow through both the clitoris and the tissue around the urethra, thereby~     improving sexual function and decreasing FOD.~      In addition, it has been shown that women who easily achieve orgasm are more likely than~     women with FOD to have a larger clitoris and a clitoris positioned closer to the vaginal~     wall. Since PRP has been shown to increase connective tissue, injection of PRP into the~     clitoris may potentially enlarge the clitoris and may bring the clitoris closer to the~     vaginal wall, thereby improving orgasm.~      There are some reports that physicians using the PRP as an injection near the urethra and~     clitoris have seen some patients with improvement in FOD after the injections. This is the~     first study that uses an objective comparative study to find out if this treatment works or~     not.~   "
28860|NCT03189225|"~     This study is to evaluate accuracy between product platforms in the hands of users, comparing~     capillary to venous response vs YSI reference instrument as well as the local hospital~     analyser.~   "
28861|NCT03189212|"~     The purpose of this study is to determine whether a telemedicine follow-up visit at the NYU~     Langone Transplant Institute is a feasible and acceptable alternative to a traditional~     in-center follow-up visit.~   "
28862|NCT03189199|"~     The purpose of this study is to make a cohort event monitoring to see whether and how~     Dazhuhongjingtian injection in hospital results in adverse events or adverse drug reactions~   "
28863|NCT03189186|"~     Patients will undergo a screening process as per standard of care to identify disease type~     and severity. Careful history and physical examination will also take place to rule out major~     heart, lung, or kidney disease and pregnancy that may affect how they will respond to the~     treatment. Patients with advanced (stage II and above with multiple tumors or tumors within~     vessels) and metastatic Renal Cell Carcinoma will be first treated with cryoablation on a~     large primary tumor and then given 200 mg pembrolizumab every 3-weeks 3 cycles , followed by~     partial/radical nephrectomy. Pembrolizumab is a biologic drug that adheres to the cell death~     receptors on white blood cells preventing there death and leading to an increased immunologic~     response. Cryoablation will be used in these patients to initially trigger and immune~     response to cancerous cells that is then magnified by the drug. After the surgery, patients~     will resume pembrolizumab for additional 5 cycles or up to a total of 2 years if a partial~     response is observed at the discretion of the treating medical oncologist or urologist until~     complete tumor remission, disease progression, unacceptable toxicity, patient refusal, or~     patient death due to any cause.~   "
28864|NCT03189173|"~     The current study combines two treatments for obstructive sleep apnea (OSA), oral appliances~     and supplemental inspired oxygen. The following aims will be tested:~      Aim 1. To determine whether supplemental inspired oxygen further reduces OSA severity~     (apnea-hypopnea index) in patients using an oral appliance.~      Aim 2. To determine whether baseline OSA phenotypes can predict the efficacy of oral~     appliances versus supplemental oxygen versus both treatments in combination. We will test~     whether responders to oral appliances have distinct pathophysiological characteristics~     compared with oxygen responders.~   "
28865|NCT03189160|"~     This study aims to explore the optimal dose of pegylated recombinant human growth hormone~     (PEG-rhGH) injection to treat children of Turner syndrome (TS), preliminarily evaluate its~     safety and efficacy and provide scientific and reliable evidence for the medication dosage in~     Phase 3 clinical trial.~   "
28866|NCT03189147|"~     The appropriate treatment of labral lesions such as SLAP tears in patients undergoing RC~     tears repair is controversial. Most surgeons are reluctant to repair RC and SLAP tears~     simultaneously due to the high likelihood of prolonged postoperative immobilization,~     stiffness and poor clinical outcomes. The current standard care interventions include~     debridement, biceps tenotomy or tenodesis rather than surgical repair of SLAP tears. Simple~     debridement is a low cost and time-saving procedure that has the advantage of maintaining the~     anatomy of the long head of biceps (LHB), a muscle that acts as an active depressor of the~     head of the humerus in patients with RC tears. Biceps tenotomy is also low cost and~     time-saving; however, since the LHB is released from its attachment in the shoulder joint,~     the anatomy is not preserved and results in decreased strength and possible development of a~     'Popeye' deformity. Biceps tenodesis has higher costs and time than the other two approaches,~     but has the advantage of preserving the LHB anatomy and power, and a lower possibility of~     developing complications. Finally, labral repair has the highest costs and associated~     surgical time and may lead to increase stiffness after surgery, particularly in patients over~     45 years old.~      Currently, the standard care of the surgeons involved in this study is to use either~     debridement or biceps tenodesis to address labral lesions in patients undergoing surgery for~     their RC tear. Based on the current evidence and current practice in our facility, we aim to~     compare the efficacy of tenodesis versus debridement in patients with combined RC tear,~     degenerative labrum (SLAP tears) and a normal biceps tendon.~   "
28867|NCT03189134|"~     The investigators propose to translate confocal microscopy for use during open heart surgery.~     This tool will help discriminate between various types of tissues in the heart during~     surgery. One of the most feared complication after heart surgery is heart block. This~     flexible fiberoptic confocal microscope will help discriminate between the various types of~     tissues in the heart and thus help avoid injury to the conduction tissue during surgery.~   "
28948|NCT03188081|"~     The primary objective of this study is to investigate whether an Educational Supported~     Program (ESP), including tight control procedures implemented through patient home care, has~     positive impact in terms of better adherence to the therapy with abatacept SC at 12 months~     after treatment start (1st injection). In the scope of this objective the adherence is~     measured by the Medication Adherence Questionnaire (MAQ).~   "
28868|NCT03189121|"~     Background:~      Increases in obesity, diabetes, and some metabolic disorders may be linked to how much~     processed foods people eat. Researchers want to learn more about how processed foods affect~     metabolic health.~      Objective:~      To learn about how a processed versus unprocessed diet affects the body.~      Eligibility:~      Men ages 18-50 with stable weight and risk factors for diabetes~      Design:~      Participants will be screened over 3 visits. Screening includes:~        -  Medical history and physical exam~        -  Heart and blood tests~        -  Psychiatric questions~        -  Questions about eating, sleeping, and economic status~        -  Riding a stationary bike~        -  Trying a sample meal~      Between screenings, participants will eat prepared meals. They will wear an accelerometer to~     measure physical activity. They will write down what foods they eat and monitor their weight.~      Participants will have two 4-week stays in the clinic. They will:~        -  Eat a special diet~        -  Have activity and weight monitored~        -  Drink water and collect urine samples to measure how many calories they are burning~        -  Have resting energy expenditure measured with a clear hood over the head~        -  Have a scan to measure body fat and bone density using low-dose x-rays~        -  Have a scan on a table that slides into a metal cylinder in a strong magnetic field.~          They will get earplugs for the loud noises.~        -  Have an ultrasound test to measure blood vessels~        -  Have insulin and glucose infused into an arm vein. Blood will be taken over 10 hours~          through a plastic tube in the wrist. This will happen 4 times.~        -  Spend multiple 24-hour periods in a room that measures oxygen used and carbon dioxide~          produced.~        -  Give blood, urine and stool samples~        -  Answer questionnaires and do computer tasks~   "
28869|NCT03189108|"~     Background:~      Researchers want to study fluids and blood of people with cancer. The fluids are from the~     abdomen and around the lungs. Studying these might help researchers learn about the biology~     of cancer. This may lead to better ways to treat cancer.~      Objectives:~      To study the biology of cancer.~      Eligibility:~      Adults 18 and older with malignant solid tumors.~      Design:~      Participants will be screened with medical history, blood tests, and confirmation of~     diagnosis.~      Participants will have samples taken at regularly scheduled procedures. Fluids from the~     abdomen and/or lungs will be taken as part of the procedures. Blood will be taken separately.~      Participants may be asked to give more samples at future procedures.~   "
28870|NCT03189095|"~     Project WOWii examines how useful and effective an online format is for helping people with~     SCI get more exercise over 4 months. Study participants will meet over Skype weekly for 16~     weeks and work through weekly online modules to start and stick with an accessible and~     individualized exercise program. Participants will be compensated for their time to attend~     fitness testing and complete surveys before and just after the 16-week program.~   "
28871|NCT03189082|"~     The purpose of this study is to evaluate the efficiency of the intradermal injection of~     botulinum toxin in lower face rejuvenation. The study will also compare this intervention~     with the Nefertiti Lift intramuscular injection technique.~   "
28872|NCT03189069|"~     The primary purpose of this study is to evaluate the risk of major bleeding and~     stroke/systemic embolism (SE) among novel oral anti-coagulant (OAC) naïve and warfarin naïve~     Medicare Advantage patients with non-valvular atrial fibrillation (NVAF) treated with~     apixaban, dabigatran, rivaroxaban, or warfarin.~   "
28873|NCT03189056|"~     Chagas disease is one of the most neglected vector-borne infectious disease worldwide. The~     first decades following the discovery of the pathology drove an international research~     enthusiasm, mainly concentrated on understanding the typical cardiac and digestive forms.~     Recently, research have been focused on vector control, which has been a huge success, at the~     price of neglecting the patients who already presented fixed and severe organic lesions due~     the chronic phase of the illness.~      This study focus on a rarely studied aspect of this pathology: the involvement of the lower~     urinary tract and it's symptomatology in adults suffering from Chagas chronic disease.~      Various studies have assessed the involvement of the lower urinary tract in chronic Chagas~     disease, the vast majority of them being on the animal model or very ancient human studies~     mainly on cadaveric specimen, the first of them being the primary description of Koeberle in~     1963.~      Human symptomatology deriving from bladder, ureteral and urethral chronic chagasic lesions~     are yet widely unknown, and only a few Brazilian and Mexican studies have intended to~     describe the clinical and urodynamic presentation of these patients.~      The aim of this study is to assess the prevalence of urinary disorders in chronic chagasic~     patients and to describe their symptoms, through a complete clinical, ultrasonographic and~     urodynamic description.~   "
28874|NCT03189043|"~     This is a controlled open label efficacy study of Aionx antimicrobial surface for the~     prevention of healthcare-associated infections.~   "
28875|NCT03189030|"~     This study will evaluate the safety and tolerability of a personalized live, attenuated,~     double-deleted Listeria monocytogenes (pLADD) treatment in adults with metastatic colorectal~     cancer.~   "
28876|NCT03189017|"~     This is a single center, randomized, double-blind, placebo-controlled, dose escalation study~     in healthy subjects to evaluate the safety, tolerability, pharmacokinetics and~     pharmacodynamics of ICP-022 following oral single and multiple escalating dose~     administration.~   "
28877|NCT03189004|"~     1. Burden:~           In global perspective, it is estimated that the lives of 150,000 women could be saved~          each year worldwide with access to sufficient family planning services. It is indicated~          that only 26 percent women received four or more antenatal care (ANC) visits during~          their pregnancies, while 67.7 percent received at least one ANC during their pregnancies~          which are the great challenges for ensuring safe motherhood in the country. As a part of~          safe motherhood, it is estimated that only 28.8 percent deliveries are being conducted~          in health facilities in the country. In case of postnatal care (PNC), from 2008 to 2010,~          only 27 percent of women received PNC for their last deliveries from a medically-trained~          provider within two days of their delivery. Despite the tremendous success of expanded~          programme on immunization (EPI) in Bangladesh, a substantial number of children are not~          fully vaccinated under EPI as data shows 82 percent were fully vaccinated by the age of~          12 months.~        2. Knowledge gap:~           Use of technology for covering all or major components of primary health care (PHC) is~          yet to be developed and tested in Bangladesh. Further, no such initiative has yet been~          taken focusing community clinic (CC) to ensure equity of services in Bangladesh.~        3. Relevance:~      At present in Bangladesh, the CCs cater the services on family planning, maternal neonatal~     and child health (MNCH), health education for the rural people by using e-health strategy as~     the community health care provider (CHCP), newly recruited staff of community clinic are~     equipped with internet connected laptop service. So, updated technology for updating~     information, follow up and referral in primary health care can be used to increase the~     utilization of health services.~      Hypothesis (if any):~      Use of smart phones by community level healthcare providers will increase utilization of~     reproductive health (RH) and family planning (FP), MNCH, integrated management of childhood~     illness (IMCI), EPI and other PHC services at rural communities in Bangladesh.~      Objectives:~      To develop and test a mechanism as well as assess the impact of mHealth strategy to improve~     RH and FP, MNCH, IMCI, EPI and other PHC services in rural communities of Bangladesh.~      Methods:~      The service delivery personnel who are providing the services to the community people at~     different levels (community clinic, union health and family welfare centre, upazila health~     complex) will be equipped with smart phones having the facilities for text messages, voice~     messages as well as internet and data capturing. Training on handling of the smart phones,~     data capturing and monitoring will be provided to service providers in each upazila. They~     will be trained to input, edit, verify and monitor the data on different services through the~     software installed in their smart phones. The community clinic management and support groups~     will be oriented and motivated on mobile phone based registration, notification and referral~     to the health facilities.~      Outcome measures/variables:~      This will be a quasi-experimental pre-post design study and evaluation will be done through~     comparing antenatal care (ANC), postnatal care (PNC), and contraceptive prevalence rate (CPR)~     and EPI coverage before and after its implementation in the study versus comparison areas.~     The study will be conducted over a period of 30 months.~   "
28878|NCT03188991|"~     This study will evaluate intracystic NanoPac® (Sterile Nanoparticulate Paclitaxel)~     administered via endoscopic ultrasound-guided fine needle injection (EUS-FNI) in subjects~     with mucinous cystic pancreatic neoplasms.~   "
28906|NCT03188627|"~     Chronic Obstructive Pulmonary Disease (COPD) is usually characterized by long-term poor~     airflow, resulting in chronic pulmonary heart disease, chronic respiratory failure or even~     death. For COPD patients, pulmonary bronchus structures are damaged and cannot be repaired by~     recent clinical methods so far. This study intends to carry out a single-centered and~     non-randomized phase I/II clinical trial with concurrent controls to investigate whether~     bronchial basal cells can regenerate damaged lung tissue. During the treatment, bronchial~     basal cells will be isolated from patients' own bronchi and expanded in vitro. After careful~     characterization, expanded cells will be transplanted autologously into the lesion by~     fiberoptic bronchoscopy. The safety and efficacy of the treatment will be monitored by~     measuring the key clinical indicators.~   "
38692|NCT03060239|"~     The purpose of this study is to confirm the improvement of movement during RBD in Parkinson's~     disease and to explore the neuronal network involved in this improvement using NIRS.~   "
28879|NCT03188978|"~     Primary failure is the most common complication of newly created arteriovenous fistulas~     (AVFs) and an important contributor to end stage renal disease (ESRD) patients' morbidity and~     mortality. Recently, the investigators have found that high intensity atorvastatin (40~     mg/day) reduces AVF primary failure significantly when compared to other statins or no statin~     treatment in three separate prospective and retrospective studies done in collaboration with~     the University of Miami. Based on these findings and considering the necessity for a therapy~     to improve AVF maturation rates, the investigators propose the realization of a feasibility~     pilot double blinded randomized controlled trial (RCT). In this study, a total of 50 patients~     will be randomly allocated to receive high intensity atorvastatin (40 mg daily) or placebo~     starting at two weeks before surgery and until the end of the observational period (6 weeks~     after surgery). Present trial will reveal crucial feasibility information such as the~     appropriateness of the eligibility criteria, patient recruitment and retention rates,~     compliance, adverse events, efficacy of patient follow-ups, and readiness of the facilities~     and involved personnel; while having as a secondary endpoint the predictive measurements of~     diameter and AVF blood flow 6 weeks after fistula creation useful for the estimation of the~     probable effect of proposed intervention. Here, the investigators aim to pave the way for a~     future multicenter Phase II RCT seeking to prove the efficacy of atorvastatin therapy as a~     perioperative intervention to reduce AVF primary failure.~   "
28880|NCT03188965|"~     The ATR(ataxia-telangiectasia and Rad3 related protein) inhibitor BAY1895344 is developed for~     the treatment of patients with advanced solid tumors and lymphomas. The purpose of the~     proposed trial is to evaluate the safety and tolerability of BAY1895344, and to identify the~     maximum tolerated dose of BAY1895344 that could be safely given to cancer patients. Further,~     the response of the cancer to the treatment will be determined.~   "
28881|NCT03188952|"~     1. A total of 40 volunteer patients will be assigned in this study.~        2. All patients will be randomly selected with variable caries risks .~        3. For each patient The Examiner will use Two screening methods used in caries detection ,~          where D1 represents ICDAS index and D2 represents ICCMS index which are used by each~          examiner for each patient.~        4. Each examiner will record the dental findings using the visual- tactile assessment~          method .The visual-tactile assessment method includes the use of mirror, probe under~          good illumination condition~        5. After full caries assessment in the 1st visit , All patients will receive full treatment~          and oral hygiene control .~        6. After 6-months follow up re-assessment of same patients will be done by same Examiners .~        7. The data of each examiner will be collected, and then the repeat-ability and the~          reproducibility of each method as well as the inter- and intra-operator agreement will~          be evaluated using the kappa statistics~             -  Number of visits & follow up period: There will be 2 visits and 6-months follow up~               between 2 visits.~             -  Direct benefit of the research to the human volunteer:To get the most appropriate~               treatment plan .~             -  Scientific Value and social benefits:obtain better information quality and support~               Dentist Discussion making.~             -  Expected risk to human subjects:: the ordinary side effects associated with any~               restorative treatment and no of the study variable has side effect on the patient~               and in case of any side effect due to the restorative treatment , the participant~               will directly contact the operator.~   "
28882|NCT03188939|"~     Supraclavicular block of brachial plexus is a type of regional anesthesia sometimes employed~     as an alternative to general anesthesia for surgery of the forearm. Many approaches have been~     described for ultrasound-guided supraclavicular block of the brachial plexus , Double-~     injection technique , single-injection and intra- cluster-injection technique. In intra-~     cluster-injection technique.The comparison between the 3 techniques may allow detecting the~     most beneficial one. the investigators hypothesized that intra-cluster-injection technique~     will be associated with more rapid onset, longer duration and the least complications.~     (because the trunks and divisions of the brachial plexus are relatively close as they travel~     over the first rib, the onset and quality of anesthesia will be faster and complete) Methods~     : This study will be conducted at kasr al ainy Hospital Cairo university After obtaining~     ethics committee approval and written informed consent 36 patients (who will undergo surgery~     for forearm)included in the study classified into three groups Gs single injection technique~     ,Gic intra- cluster injection technique, Gd double injection technique After block will be~     done, a second investigator will examine the patient for sensory and motor block (every 10~     minutes for 30 minutes) and for occurrence of complications. The patient will be ready for~     surgery when the score ≥14 point. At this point the onset will be determined and so the~     patient can be transferred to the operating room .~      If the patient experienced anxiety, propofol infusion (80-250 ug/kg/min) can be started. If~     the patient experienced pain during surgery the block considered failed and induction of~     general anesthesia should be started.~      After end of the surgery the second investigator will continue to assess the patient for post~     operative pain every one hour for 24 hours to determine duration of the block.~   "
28883|NCT03188926|"~     To provide treatment guidelines for patients with long bone metastatic disease based on~     observational study and to propose an algorithm to guide orthopedic surgeons in~     decision-making for these patient.~   "
28884|NCT03188913|"~     Prospective observational study in which FXIII levels and coagulation tests and cicatrization~     are measured during the 30 days after the thermal trauma.~   "
28885|NCT03188900|"~     The aim of the study is to setup a collection of maternal plasma and serum from patients with~     preeclampsia and normal pregnancy for in vitro validation of new therapeutics based on~     extra-corporal removal of sFlt-1~   "
28886|NCT03188887|"~     TIGER study (Treatment of IgA nEphropathy according to Renal lesions) is a prospective openly~     randomized controlled study.~      The main objective is to evaluate the efficacy of early corticotherapy + RAS blockade (versus~     RAS blockade alone) after two years of evolution in IgAN patients with severe histological~     lesions The study will include 122 IgAN patients, it is scheduled to start in september 2017.~   "
28887|NCT03188874|"~     This is a registry study in adult patients with newly diagnosed or refractory/relapsed acute~     myeloid leukemia.~      Investigator's sites: 40 sites in Germany.~      Primary objectives:~        -  Identification of epidemiological data on AML: age, prognostic factors and subgroup~          distributions. Incidence and age distribution are compared with the data of~          population-related tumor registry.~        -  Evaluation of the most important patient-relevant clinical endpoints (outcomes):~          relapse-free survival (RFS) / time to relapse (TTR), calculation of cumulative incidence~          of relapse (CIR) and overall survival (OS)~        -  Documentation of treatment strategy~   "
28888|NCT03188861|"~     EMASPOT assesses the prevalence and impact of mental health conditions in multimorbid~     emergency patients with cardiac ACSC on transsectoral utilisation of health care services.~   "
28889|NCT03188848|"~     This is a randomized, double-blind, placebo-controlled, dose finding study evaluating the~     safety, pharmacokinetics and pharmacodynamics of subcutaneously injected BPI-3016 in Chinese~     healthy subjects.~   "
28890|NCT03188835|"~     Activating brown and beige adipose tissue (herein described as BAT) has been recently~     recognized as a potential means to increase energy expenditure and lower blood glucose,~     however, BAT activity appears to be reduced with obesity, aging or Type 2 Diabetes (T2D). BAT~     has the unique capability to burn large amounts of sugar and fat and effectively dissipate~     this energy as heat due to the expression of uncoupling protein 1 (UCP1) which is controlled~     by a thermogenic gene program of transcription factors, co-activators and protein kinases.~     Thus, enhancing the thermogenic gene program may be beneficial for treating obesity and T2D.~     Despite the importance of BAT in regulating metabolism our understanding of the factors which~     suppress its metabolic activity with obesity, aging and T2D are largely unknown. Recently, it~     was shown that peripheral serotonin, which is regulated by the tryptophan hydroxylase 1~     (Tph1), is a negative regulator of BAT metabolic activity. In addition to serotonin, other~     studies have indicated that pro-inflammatory stimuli may also inhibit BAT metabolic activity.~     These data suggest that reduced activation of BAT may be due to increases in peripheral~     serotonin and inflammation. Importantly, the gut microbiome has recently been recognized as~     an important regulator of serotonin and inflammatory pathways suggesting the observed effects~     of the microbiome on obesity, T2D may be mediated in part through reductions in BAT activity.~      One mechanism by which the environment may impact BAT activity and the thermogenic gene~     program over the last 3 decades involves changes in our food supply as result of changes in~     agricultural production (chlorpyrifos, glyphosphate) and the addition of food additives~     (fructose). These agents have been reported to alter inflammation, serotonin metabolism and~     the gut microbiome indicating a potential bimodal (direct and indirect via the microbiome)~     mechanism by which they may alter the thermogenic gene program and contribute to chronic~     metabolic disease. Thus, our overarching hypothesis is that environmental agents and~     additives related to food production may contribute to the reduced metabolic activity of BAT.~     The objective is to identify and characterize how food production agents and additives reduce~     the metabolic activity of BAT.~   "
28891|NCT03188822|"~     The purpose of this study is to compare how two different post-surgical treatments that both~     deliver steroids to the frontal sinus opening affect your healing after frontal sinus~     surgery.~   "
28892|NCT03188809|"~     After total knee prosthesis surgery, in the first postopertive days, serious pain complaints~     occur in the patients and this causes many problems, especially mobility limitation. For this~     reason, a strong analgesic is needed. As a part of multimodal analgesia after total knee~     surgery, nerve blocks are frequently preferred. While central nerve blocks are preferred in~     the forefront, peripheral nerve blocks are frequently preferred due to complications related~     to central nerve blocks. Femoral nerve block and adductor channel block are the preferred~     peripheral blocks for total knee prosthesis. Since early mobilization after total hip~     prosthesis is very important, it is aimed to provide sufficient analgesia by making less~     motor block. Previous studies have shown that adductor channel block provides similar~     analgesia with femoral nerve block. Early mobilization, early discharge and the impact on the~     risk of falls are not yet clear, although it is estimated to be in the positive direction.~     Again, previous studies have compared single doses and infusion doses but no repeated bolus~     doses. Repeated bolus doses have been shown to be more effective in studies in which adductor~     channel catheters have been introduced to date to compare infusion and recurrent bolus doses.~      investigators aimed to compare the effects of repeated bolus doses with femoral nerve~     catheter and adductor channel catheter on postoperative pain and muscle strength in patients~     undergoing total knee replasment under spinal anesthesia in this study.~   "
28893|NCT03188796|"~     In the VITdAL-ICU trial using a large oral dose of vitamin D3 in 480 adult critically ill~     patients, there was no benefit regarding the primary endpoint hospital length of stay.~     However, the predefined subgroup with severe vitamin D deficiency (25(OH)D ≤ 12ng/ml) had~     significantly lower 28-day mortality (36.3% placebo vs. 20.4% vitamin D group, HR 0.52~     (0.30-0.89), number needed to treat = 6). Therefore, high-dose vitamin D3 in a population of~     severely vitamin D deficient critically ill patients is a promising and inexpensive~     intervention that requires confirmatory multicenter studies.~      To date, only 7 interventions (e.g. noninvasive ventilation or prone positioning) have ever~     demonstrated mortality benefit for Intensive Care Unit (ICU) patients in multicenter trials.~     In case of benefit, vitamin D treatment in critically ill patients could be immediately~     implemented worldwide.~   "
28894|NCT03188783|"~     The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of~     single and multiple oral doses of GDC-0853 in healthy Japanese and Caucasian subjects.~   "
28895|NCT03188770|"~     The purpose of this international, multicenter service review is to describe and compare~     ventilation management in patients at risk of acute respiratory distress syndrome (ARDS)~     versus patients not at risk and patients with established ARDS, and to ascertain whether~     certain ventilator settings and ventilation parameters are associated with pulmonary~     complications or development of ARDS after start of ventilation in patients in intensive care~     units (ICUs) in Asian countries.~      Participating centers will include adult patients undergoing mechanical ventilation in the~     ICU during a 28-day period. Patients' data will be collected during the first 7 days in the~     ICU, or until ICU discharge. Follow up is until ICU discharge. The primary outcome includes~     two main ventilator settings, i.e., tidal volume and the level of positive end-expiratory~     pressure. Secondary endpoints are development of ARDS in patients without ARDS at the onset~     of mechanical ventilation, worsening of ARDS in patients with ARDS at the onset of mechanical~     ventilation, pulmonary infection, other pulmonary complications, need for tracheostomy,~     duration of ventilation, length of ICU stay and ICU mortality.~   "
28896|NCT03188757|"~     The study is going to include 20 adolescents, 5-10 years after onset of T1D, aged 12-20~     years, on insulin pump. The participants are going to have MRI of the head in euglycaemic and~     hyperglycaemic state. During both MRI, the participants are going to preform Flanker test,~     Tower of London test and Spatial memory test. The investigators are going to evaluate the~     response of inflammation markers and oxidative stress marekers in blood during~     hypreglycaemia.~   "
28907|NCT03188614|"~     Fluid resuscitation is important in shock therapy, but the choice of fluids, especially the~     choice of crystalloid is under debate. It is said that normal saline is related to~     hyperchloremia， which might lead to acute kidney injury. Thus the hypothesis of the study is~     to explicit whether balanced salt solution could reduce the incidence of acute kidney injury~     when compared with normal saline.~   "
28908|NCT03188601|"~     Create a personalized time and context curve of patient circulating α1-antitrypsin (AAT)~     levels and functions before hematopoietic stem cell transplantation and throughout~     progression into GVHD.~      PRIMARY ENDPOINT 1. Serum AAT levels and activity, before myeloablative preconditioning, as~     well as on days (-3),0,7,14,28 from HSCT and every 21 days thereafter.~      SECONDARY ENDPOINTS 1. Correlation between AAT patterns and:~        -  Circulating immune cell activation profiles on day of ablation, 28 days from HSCT and~          once GVHD is diagnosed.~        -  Patient survival~        -  Liver function tests~        -  GVHD grade: skin manifestations, weight, GI and liver histopathology~        -  Graft-versus-leukemia effect~   "
38693|NCT03060226|"~     Search for blood predictive marker (s) for cutaneous radiosensitivity~   "
28897|NCT03188744|"~     Introduction: Pelvic floor muscle dysfunctions (PFMD) represent a major public health problem~     manifesting through lower urinary tract symptoms (LUTS), anorectal and sexual dysfunction.~     PFMD is a common problem in cervical cancer (CC) survivors with a negative impact in quality~     of life (QoL). Aim: This study aims to assess the effect of the exercise protocol in the~     overall quality of life. Secondly, it is aimed to evaluate the effect of a exercise protocol~     in the PFMD; the QoL in the PFMD and the adherence to exercise protocol. Methods: Patients~     with a diagnosis of CC, of any stage, histology and grade, accompanied by the Oncology~     Gynecology Service of the Clinic Hospital of Medical School of Ribeirão Preto of University~     of São Paulo will be studied in the period between 2004 and 2014. For the analysis of the~     prevalence of PFMD will be applied the Discomfort Questionnaire on the Floor Pelvic (PFDI-20)~     for evaluation of pelvic organ prolapse (POP) complaints, anorectal symptoms and urinary~     incontinence, and the Sexual Questionnaire for Urinary Incontinence and Pelvic Organ Prolapse~     (PISQ-12) for evaluation of sexual function. Both questionnaires have already been validated~     for the Portuguese language and are specific for women with PFMD. The Pelvic Floor Impact~     Questionnaire (PFIQ-7) will also be applied to assess the impact of PFMD on QoL, daily life~     activities and emotional health. For the evaluation of overall QoL, the EORTC QLQ-C30~     questionnaire and its specific module for patients with CC, QLQ-CX24, will be used. Patients~     evidenced with PFMD through the application of the proposed questionnaires will be invited to~     participate in a exercise protocol with sessions held once a week with a duration of 45~     minutes each during the period of 12 week. Protocol will be supervised by a single~     physiotherapist.~   "
28898|NCT03188731|"~     The aim of this proposal is to evaluate the causal relationship between Zika virus (ZIKV)~     infections in pregnancy and congenital malformations. We will estimate the absolute and~     relative risks of congenital malformations and other adverse outcomes of pregnancy among~     women who become infected with ZIKV during pregnancy compared to uninfected pregnant women,~     also leading to further validation of the Congenital Zika Syndrome.~   "
28899|NCT03188718|"~     Validation study of a novel sleep Device compared to a traditional sleep study.~   "
28900|NCT03188705|"~     This study builds, in part, upon preliminary results generated as part of the~     Pharmacogenomics Anti-Platelet Intervention (PAPI) Study (NCT00799396). The purpose of this~     investigation is to assess the impact of genetic variation in the carboxylesterase 1 (CES1)~     on response to clopidogrel as well as dual antiplatelet therapy (i.e. clopidogrel and~     aspirin), as assessed by ex vivo platelet aggregometry, in healthy Amish individuals. The~     investigators hypothesize that participants who carry alleles that modify the activity or~     expression of CES1 will have altered response to clopidogrel as well as dual antiplatelet~     therapy.~   "
28901|NCT03188692|"~     The purpose of this study is to evaluate the safety and efficacy of an intramuscular~     injection of BK1310 in healthy infants.~   "
28902|NCT03188679|"~     Cytomegalovirus (CMV) is the most common cause of congenital infection, with approximately~     0.5% of pregnant women being infected during pregnancy. CMV transmission to the fetus occurs~     in about one third of women who are infected in first trimester. Babies infected before birth~     are at risk for serious neurological complications such as intellectual disability, seizures,~     deafness, and even death. Most couples facing a diagnosis of congenital cytomegalovirus~     infection in their unborn baby focus heavily on the predicted neurological outcome for their~     child. To date, methods to assess brain development in fetuses have been mainly limited to~     detecting structural brain abnormalities by ultrasound. However, these ultrasound signs may~     not become apparent until very late in pregnancy, and some neurological disability is not~     accompanied by any structural brain changes. More research on methods of predicting~     neurodevelopmental outcome independent of structural brain malformations before third~     trimester is urgently needed.~      The purpose of this study is to investigate a new method of studying the health of unborn~     babies using amniotic fluid. Amniocentesis is often performed after maternal CMV infection to~     diagnose fetal infection. Prior research by Dr Hui has demonstrated that cell free RNA in~     amniotic fluid can provide meaningful information from multiple organs including the fetal~     brain. The investigators propose to collect and analyse a small sample of amniotic fluid to~     detect which genes are turned on or off (gene expression) in a fetus that has a~     congenital CMV infection, compared to those without any infection.~      The genes that are differentially expressed in CMV infected fetuses will then be analysed to~     provide information on the broad physiological processes that are altered due to the~     infection (functional analysis) and identify neurodevelopmental gene transcripts of~     interest for future studies (biomarker discovery).~   "
28903|NCT03188666|"~     This is a two period study design consisting of a 6-month, randomized, double-blind~     placebo-controlled treatment (period 1) followed by a 6-month, open-label treatment (period~     2).~      Primary safety objective of the study is to assess the safety and tolerability of REGN2477 in~     male and female patients with fibrodysplasia ossificans progressiva (FOP).~      Primary efficacy objective of the study is to assess the effect of REGN2477 versus placebo on~     the change from baseline in heterotopic ossification (HO) in patients with FOP, as determined~     by 18-NaF uptake in HO lesions by positron emission tomography (PET) and in total volume of~     HO lesions by computed tomography (CT).~      Secondary objectives are:~        -  To assess the effect of REGN2477 versus placebo on the change from baseline in HO, as~          determined by the number of new HO lesions identified by 18F-NaF PET or by CT~        -  To assess the effect of REGN2477 versus placebo on the change from baseline in 18F-NaF~          standardized uptake value maximum (SUVmax) of individual active HO site(s) by PET~        -  To compare the effect of REGN2477 versus placebo on pain due to FOP, as measured by the~          area under the curve (AUC) for pain based on daily numeric rating scale (NRS) scores~        -  To assess the effect of REGN2477 versus placebo on the change from baseline in~          biochemical markers of bone formation~        -  To characterize the concentrations of total activin A at baseline and over time~          following the first dose of study drug~        -  To characterize the concentration-time profile (pharmacokinetics [PK]) of REGN2477 in~          patients with FOP~        -  To assess the immunogenicity of REGN2477~   "
28904|NCT03188653|"~     This will be a single visit study that will take approximately 2 hours. Up to 50 subjects (up~     to 25 healthy subjects, and up to 25 subjects with AD) from BUMC dermatology clinics will be~     enrolled in this study and randomized to receive the 7 cleansers on 7 test spots on their~     upper extremities. One spot will serve as a control and not receive any cleanser. Each spot~     will be cleansed with the corresponding cleanser for 15 seconds then rinsed off with tap~     water. Skin barrier will be measured at baseline, immediately after, 30, 60 and 90 minutes~     after rinse off.~   "
28905|NCT03188640|"~     The purpose of this study is to characterize the hormonal status in fertile women undergoing~     laparoscopic gastric bypass, pre- and postoperatively, and evaluate if there is a correlation~     between health-related quality of life and proposed hormone changes post-operatively.~   "
28910|NCT03188575|"~     Depression and anxiety are common mental health problems. There are effective treatments for~     depression and anxiety and one of these is talking therapies using cognitive behaviour~     therapy (CBT). In recent years CBT has been transferred to online delivery methods and these~     interventions have proven successful for people being treated with symptoms of depression and~     anxiety.~      The current study will utilise a randomised controlled trial design, where the majority~     (n=240) of participants will be allocated to the immediate treatment (internet-delivered CBT~     for either depression or anxiety), and a smaller number (n=120) will be allocated to a~     waiting list. The waiting list group will receive treatment after an eight week wait. This~     design helps us to understand that any changes in symptoms in the treatment group will be~     likely due to the treatment they received compared to the waiting list.~      A sample size of 360 participants is proposed and has been adjusted to ameliorate against~     patient dropout. Follow-up and maintenance of any positive changes in symptoms is very~     important in CBT for depression and anxiety, simply because some people can have a relapse of~     symptoms. We will therefore follow-up the treatment group for 3, 6, 9 and 12 months to assess~     maintenance of positive gains from treatment.~      The study also seeks to investigate the cost effectiveness of the treatments.~   "
28911|NCT03188562|"~     The aim of the study is prospective comparison of diagnostical and therapeutical efficiency~     between different methods of mediastinal lymph node preoperative staging in Non-Small-Cell~     Lung Cancer (NSCLC).~      Two hundred patients with histologically/cytologically confirmed clinical stage primary~     I-IIIA NSCLC will be included. The patients must be fit enough to undergo at least pulmonary~     lobectomy. Computer Tomography (CT) and Positron Emission Tomography (PET/CT) will be~     performed in all patients. Subsequently, the patients without evidence of dissemination will~     be randomized to transbronchial and transesophageal endoscopic ultrasound-guided needle~     aspiration ( EBUS-TBNA, EUS-NA) or Transcervical Extended Mediastinal Lymphadenectomy~     (TEMLA). The patients with N3 will be referred to definitive oncological treatment, the~     patients with N2 metastases will be referred to neoadjuvant treatment and the patients~     without N2/3 metastases will be operated on. The operative procedure will include at least~     lobectomy with complete lymphadenectomy, with open or video-assisted (VATS) technique. The~     patients undergoing sublobar resection will be excluded from this study. Final analysis will~     include comparison of the diagnostic yield and 5-year survival between the EBUS/EUS and the~     TEMLA arms.~   "
28912|NCT03188549|"~     Background: Procedures of hand hygiene are an important component in prevention of~     cross-transmission of infections in hospitals. In recent years, hand washing with antiseptic~     soap (chlorhexidine) was replaced with use of alcohol-based hand rub. This change brought an~     increase in compliance with hand hygiene regulations from 30-40% to over 50%, and in other~     places up to 70%. However, even 70% compliance is not enough. One of the reported reasons for~     lack of compliance of staff to the use of alcohol-based preparations is skin irritation and~     dryness of the hands as a result of frequent use. At Sheba, like the majority of Israeli~     hospitals, the product used for handwashing is Septol (Teva), which includes 0.5%~     chlorhexidine gluconate (CHG) and 70% ethyl alcohol. The CDC, WHO and FDA guidelines approve~     for use of hospital hand hygiene, products that contain between 61-85% ethanol.~      The investigators will replace the Septol currently used with a different alcohol-based~     antiseptic that is more user-friendly, and aim to determine whether this will increase the~     compliance with hand hygiene protocols.~      The investigators will assess~        1. Satisfaction of staff.~        2. Increase of hand hygiene compliance.~   "
28913|NCT03188536|"~     The purpose of this study is to characterize the multiple myeloma (MM) participants with~     symptomatic relapse and/or refractory disease in Spain.~   "
28914|NCT03188523|"~     This study aims to evaluate the safety, tolerability, pharmacokinetics (PK), and~     anti-retroviral therapy (ART) activity of MK-8504 monotherapy, a tenofovir (TFV) pro-drug, in~     ART-naïve, HIV-1 infected participants. The primary hypothesis is that MK-8504 has superior~     antiretroviral activity compared to placebo, as measured by change from baseline in plasma~     HIV-1 ribonucleic acid (RNA) at 168 hours postdose.~   "
28915|NCT03188510|"~     The purpose of this study is to look at the amount of the study drug, LY3074828, that gets~     into the blood stream and how long it takes the body to get rid of LY3074828 when given as~     different formulations. The tolerability of LY3074828 will also be evaluated and information~     about any side effects experienced will be collected.~      Screening is required within 28 days prior to the start of the study. For each participant,~     the total duration of the clinical trial will be approximately 13 weeks, not including~     screening.~   "
28916|NCT03188497|"~     Nasopharyngeal carcinoma (NPC) is a common malignant tumor in Southern China area, which is~     characterized by obvious regional characteristics and Guangdong cancer. Radiotherapy is the~     main treatment for locally advanced nasopharyngeal carcinoma. In recent years, chemotherapy~     has improved the short-term and long-term survival of patients with locally advanced~     nasopharyngeal carcinoma.~      Lobaplatin is the third generation platinum anticancer drugs, mechanism of action and~     traditional cisplatin is similar, mainly formed by the Pt-GG and Pt-AG chain cross connect,~     replication and transcription process blocks of deoxyribonucleic acid(DNA), thereby~     interfering with tumor cell cycle. The damage of DNA induced by lobaplatin can influence the~     expression of tumor cell specific genes. Due to the different structure of lobaplatin and no~     cross resistance to cisplatin in the study showed that, compared with cisplatin with~     gastrointestinal reaction more mild, and no cisplatin common liver and kidney toxicity,~     neurotoxicity and ototoxicity, in some tumors have a better adaptability; but compared with~     cisplatin had more severe bone marrow suppression this, offset some of the advantages of~     lobaplatin in a certain extent. At present, the clinical indications for the treatment of~     such diseases include head and neck cancer, breast cancer, gastrointestinal cancer,~     gynecologic malignant tumor and non small cell lung cancer. Tian Ying confirmed that~     lobaplatin has obvious cytotoxic effect on nasopharyngeal carcinoma cells, in a concentration~     dependent manner, the mechanism for the dual role, namely block at lower concentration of~     cells in G2 phase and induce apoptosis at higher concentration, provide the possibility for~     clinical treatment of nasopharyngeal carcinoma for lobaplatin; there are a number of clinical~     study confirmed that lobaplatin chemoradiotherapy for locally advanced nasopharyngeal~     carcinoma with cisplatin approximation. But at present, there is no report on the dose and~     tolerability of concurrent radiotherapy for nasopharyngeal carcinoma.~      Therefore, a dose escalation trial was conducted to determine maximum tolerated dose of~     lobaplat in as a single agent combined with concurrent intensity-modulated radiotherapy in a~     Chinese population with locoregionally advanced NPC.~   "
28943|NCT03188146|"~     Several risk assessment scoring systems have been proposed to assess the therapeutic response~     and predict long term prognosis in ursodeoxycholic acid (UDCA)-treated primary biliary~     cholangitis (PBC) patients, in order to risk stratify PBC patients and guide their~     management. However there scoring systems have not been fully validated in Chinese~     population. This study is going to compare the prognostic ability of these criteria, validate~     the overseas scoring systems, develop and validate a new scoring system in a cohort of~     Chinese PBC patients.~   "
28917|NCT03188484|"~     It is a randomized, observational and controlled non-blinded interventional cohort study,~     divided into two different phases of generation and validation of the screening program. From~     5,500 patients, 100 will be randomly selected for the first phase of the project to create~     and apply a sequential screening program in a high-risk population by integrating clinical,~     electrocardiographic and biological information, testing of different pulse devices~     (MyDiagnostick, AliveCor and WatchBP) for AF screening, discovery of blood biomarkers for AF~     by aptamer technology, and validation of biological candidates from the literature and~     previous results. AF diagnosis will be based on detection in four-week Holter-EKG monitoring.~     In the second phase, the investigators will apply the best candidates in a sequential~     screening program in a high-risk population (aged 65-75 with hypertension and diabetes) by~     clinical variables and performing pulse device detection. Biomarkers will be measured in the~     negative cases to perform Holter-ECG monitoring in the highest-risk patients. In the final~     step of the study, cost-efficacy analyses will be carried out.~      The main objective is to develop a clinical model for AF prediction with the combination of~     clinical information plus pulse device and blood markers in high-risk populations.~   "
28918|NCT03188471|"~     Ovarian hyperstimulation syndrome is an iatrogenic complication of controlled ovarian~     stimulation. Ovarian hyperstimulation syndrome prevention is a multistage process and more~     important than treatment.Preventive administration of GnRH antagonist for high risk OHSS~     patients from the day of oocyte retrieval is not investigated. Besides, the relevant~     mechanism is not clear yet. Here we designed a prospective randomized study to investigate~     whether GnRH anatagonist treatment after oocyte retrieval is more effective in preventing~     early ovarian hyperstimulation syndrome development than traditional aspirin preventive~     administration in women at high risk for OHSS.~   "
28919|NCT03188458|"~     The purpose of the study is to support the recommendation of vaccination of all pregnant~     women in Colombia with Diptheria, tetanus and pertussis (dTpa) by studying the transfer of~     pertussis specific IgG antibodies from mother to the child.~   "
28920|NCT03188445|"~     Intravenous iron isomaltoside versus oral iron supplementation for treatment of iron~     deficiency in pregnancy~   "
28921|NCT03188432|"~     This randomized phase II trial studies hyperthermic intraperitoneal chemotherapy or~     intraperitoneal chemotherapy in improving quality of life in patients with stage IIIC-IV~     ovarian, fallopian tube, or primary peritoneal cancer. In hyperthermic intraperitoneal~     chemotherapy, the chemotherapy is warmed before being used and may help the drugs get into~     the cancer cells better, minimize the toxicity of the drugs on normal cells, and help to kill~     any cancer cells left over after surgery. Intraperitoneal chemotherapy is delivered directly~     to the abdominal cavity to help treat cancer. It is not yet known whether hyperthermic~     intraperitoneal chemotherapy or intraperitoneal chemotherapy works better in improving~     quality of life in patients with ovarian, fallopian tube, or primary peritoneal cancer.~   "
28922|NCT03188419|"~     Background:~      People who have certain immune system diseases often need a procedure called allo HSCT. This~     is short for allogeneic hematopoietic stem cell transplant. This might cure people with these~     diseases. Many people who need allo HSCT need donors who are relatives with similar genes.~     But the disease may also affect those in the donor pool. This may mean there are fewer~     options for people with inherited diseases. Researchers want to collect data on how~     transplant candidates and their donors are found.~      Objective:~      To find out how genetic diseases and the ways they are inherited affect the breadth of~     options for allo HSCT donors.~      Eligibility:~      Records from studies that have already been done. These will be for people ages 4 and older~     who were evaluated for allo HSCT or to be donors.~      Design:~      Participants already signed a consent form for their records to be shared.~      Researchers will study the participant data.~      Data will be stored in an electronic system. Researchers will use passwords to protect the~     data.~   "
28923|NCT03188406|"~     Background:~      Gastric cancer is a leading cause of cancer deaths around the world. It is a serious problem~     in places like East Asia, Central and South America, and Eastern Europe. Researchers want to~     study the causes of gastric cancer. They want to reduce the number of people with stomach~     cancer.~      Objectives:~      To learn more about bacteria factors and other causes of gastric cancer. To study potential~     markers associated with precancer gastric lesions.~      Eligibility:~      Adults ages 40-70 at certain hospitals in Chile who:~      Are going to have endoscopies~      OR have stomach cancer and need surgery~      Design:~      Participants will give tissue samples about the size of a grain of rice.~      Some participants will donate a portion of the stomach tissue that is removed as part of~     their clinical care.~      Participants will give access to reports of their stomach exam. They will allow researchers~     to photograph the microscope slides of their tissue samples.~      Participants will answer questions. The topics of the questions include:~      Age, height, weight, ethnicity~      Education~      Habits including tobacco and alcohol~      Personal and family history of disease~      Reproductive history~      Diet~      Some participants will give blood, urine, saliva, and stool samples. Study staff will collect~     the blood. They will tell the participants how to collect the other samples themselves.~   "
28924|NCT03188393|"~     This phase II trial studies how well biopsy of breast after chemotherapy works in predicting~     pathologic response in patients with stage II-IIIA breast cancer undergoing breast conserving~     surgery. Tumor tissue collected from biopsy before surgery may help to check if chemotherapy~     destroyed the breast cancer cells and may be compared to the tumor removed during surgery to~     check if they are the same.~   "
28944|NCT03188133|"~     Occurrence of visual hallucinations (VHs) in schizophrenia depend in part on disorders in the~     processing of late visual information (Top-Down). The broader question of how these top-down~     mechanisms (cognitive and / or emotional mechanisms) are involved in the occurrence of VHs~     remains to be specified and very few behavioral studies have so far been interested. The~     investigators propose to study the implication of Top-Down mechanisms in the visual~     hallucinatory manifestations, more specifically in the processing of ambiguous stimuli during~     an emotional priming task. Schizophrenia patients with VHs would have more false visual~     perceptions in the treatment of ambiguous stimuli than schizophrenia patients with auditory~     hallucinations or no hallucinations (AH/NH) and healthy controls.~   "
28945|NCT03188120|"~     The study objective is to investigate the safety and effectiveness of Spiriva Respimat in~     patients with mild to moderate persistent asthma under real-world use~   "
28925|NCT03188380|"~     Background Necrotizing enterocolitis (NEC) is one of the most serious conditions in newborns,~     affecting up to 10% of very low birth weight infants (VLBW). In the most premature population~     mortality rates can rise as high as 60%.~      Typical findings on abdominal radiography (AR) include pnuematosis intestinalis (PI), portal~     vein gas (PVG) and pneumoperitoneum, but are sometimes not present even in severe cases.~     Abdominal ultrasound (AUS) can depict PI, PVG and pnuemoperitoneum (in some cases a head of~     AR), but it also provides other crucial information such as bowel wall viability (thickness~     or thinning) and free abdominal fluid. These additional findings are helpful in expediting~     diagnosis and management of NEC.~      Methods and analysis The hypothesis being tested is that preforming an AUR in patients with~     clinical symptoms of NEC but inconclusive/normal AR will enhance detection rates, and~     expedite treatment in infants born at <32 weeks.~      Discussion The use of AUS together with AR as an add-on test may increase the accuracy of~     diagnosing NEC, and precipitate treatment. Swift implementation of antibiotics and bowel rest~     is extremely important. To our best knowledge, our study will be the first to focus only on~     VLBW, who are most prone to NEC. It will also be the first multi-centre study evaluating the~     use of AUS as an add-on test, enabling us to recruit a significantly higher number of~     patients compared to published studies.~   "
28926|NCT03188367|"~     An emerging problem in clinical practice is how to manage the growing number of patients who~     experience symptoms related to the ingestion of gluten-containing foods gluten and in whom~     celiac disease has been ruled out. These patients most frequently report gastrointestinal~     symptoms such as diarrhea, abdominal discomfort or pain, bloating, flatulence, but also~     extraintestinal symptoms, including headache, lethargy, attention-deficit/hyperactivity~     disorder, ataxia, or recurrent oral ulceration. This heterogeneous syndrome, which has been~     reported to improve or even disappear after gluten withdrawal and to relapse after gluten~     challenge, is called non-celiac gluten sensitivity.1 The concept of nonceliac gluten~     sensitivity is not completely new. Besides several sporadic single cases reported, more than~     30 years ago an oral, double-blind, placebo-controlled, cross-over gluten challenge trial~     showed that six out of eight adult non-celiac patients, who suffered from intestinal symptoms~     caused by the ingestion of gluten-containing food, were affected by gluten-sensitive~     diarrhea. Over the last few years, an intense debate about the existence and the prevalence~     of nonceliac gluten sensitivity has emerged, as shown by the considerable increase in~     internet forums of discussion on this topic and in availability of gluten-free food. A~     definition of nonceliac gluten sensitivity based on definitive scientific evidence does not~     still exist, and the clinical trials conducted so far in order to fill this knowledge gap are~     burdened by a number of biases. In a cross-over trial of subjects with suspected NCGS, the~     severity of overall (intestinal plus extraintestinal) symptoms increased significantly during~     1 week of intake of small amounts of gluten (daily 4.375 grams), compared with placebo. Among~     the 59 participants in this trial, the Investigatotors identified only three true~     gluten-sensitive patients, defined as having a delta overall score -calculated by subtracting~     the weekly overall score under placebo from that under gluten- higher than the mean delta~     overall score plus 2 standard deviations. However, these results should be cautiously~     interpreted due to the lack of a control group of non-gluten-sensitive subjects.~      On this basis, the Investigators will conduct a randomized, dose-finding, double-blind,~     placebo-controlled, cross-over gluten challenge trial aimed at comparing the effects of a~     daily dose of 8.4 grams of gluten with those of a daily dose of 6.0 or 4.2 grams of gluten on~     a cohort of subjects with nonceliac gluten sensitivity versus healthy volunteers.~   "
28927|NCT03188354|"~     Primary central nervous system lymphoma (PCNSL) is a rare subtype of extranodal non-Hodgkins~     Lymphoma (NHL) with rising incidence and variable response to treatment. MRI is considered~     the most useful imaging modality of PCNSL, but conventional MRI has its limitations, and~     contrast-enhanced MRI sometimes does not clearly differentiate PCNSL from other neoplasm or~     non-neoplastic diseases.~      Positron emission tomography (PET) could have a number of potential advantages in refining~     and improving the management of patients with PCNSL. Because of the rare incidence of PCNSL,~     the value of PET has however not been well defined in this subtype of lymphomas. There are a~     few studies that have investigated the role for FDG-PET and amino acid PET in the primary~     staging/diagnosis and response assessment in PCNSL patients, but the results are~     inconclusive. Further studies are therefore needed.~      Previous studies support an integration of both MRI and PET for the routine diagnostic workup~     and response assessment for PCNSL, and the newly available simultaneous PET/MRI scanners may~     have the potential to improve imaging baseline accuracy, response assessment and add~     prognostic value in PCNSL.~      The main aim of the study is to compare the sensitivity and specificity of a combined PET/MRI~     examination with the clinical routine MRI examination given to these patients today. It will~     be investigated whether PET (18F-FDG and 18F-fluciclovine) can provide additional prognostic~     value at baseline and in response assessment compared to MRI and established pre-treatment~     prognostic scores in PCNSL, and evaluate which PET/MRI parameters that are best suited as an~     imaging biomarker for progression-free survival.~   "
28928|NCT03188341|"~     The vascular surgery is a highest risk procedure when considering postoperative complications~     associated with the cardiovascular system. The leading clinical presentation is acute~     hemodynamic decompensation. However, one of the possible pathomechanisms might be~     repolarization disturbances. Many of perioperative risk factors of cardiac complications are~     modifiable. The identification may help in the global perioperative risk reduction.~      Aim: The aim of the study was an identification of the factors which may release clinically~     overt repolarization disturbances.~      Methods: The study group consisted of 100 patients, diagnosed with abdominal subrenal aortic~     aneurysms or peripheral arterial disease scheduled for an elective open vascular surgery~     procedure. The authors investigated whether age, gender, comorbidities or some perioperative~     factors (including hemodynamic, metabolic or genetic) were related to the occurrence of~     clinically concealed repolarization disturbances or clinically disclosed cardiac~     complications in postoperative time up to 30 day and one year after vascular surgery~     procedure.~   "
28929|NCT03188328|"~     Local treatment of unresectable tumors is challenging, particularly with radioactivity.~     Current practice relies on external beam irradiation or on a variety of medical devices for~     brachytherapy. Both approaches proved useful in controlling tumor growth but are~     characterized by poor patient's compliance, significant side effects, high costs and~     technological complexity hampering wide-spread use. The use of AvidinOX for radionuclide~     therapy of inoperable cancer lesions will offer a number of advantages compared to current~     brachytherapy. In fact, the perfusion of a target tissue with AvidinOX, compared to current~     devices, will allow adapting the therapy to the tumor/organ shape, and it will also make it~     possible to delay the administration of radioactivity for several days which, according to~     pre-clinical studies, might be also divided up into repeated doses. AvidinOX linking stably~     to tissue proteins, does not exhibit the problem of seed migration which is associated with~     high morbidity. Based on previous findings with AvidinOX in combination with radionuclides in~     pre-clinical studies as well as data from the clinical use in liver metastases, it can be~     assumed that intralesional injections of AvidinOX followed by intravenous injections of~     177Lu-ST2210 could be a safe and efficacious method for treating inoperable tumor lesions.~   "
28930|NCT03188315|"~     Cancer is a devastating disease, presenting an immense disease burden to affected individuals~     and their families as well as health care systems with 10.9 million new cases and 6.7 million~     deaths per year. Approximately 12% of human cancers worldwide are caused by oncoviruses~     infection with more than 80% of cases occurring in the developing world.~      Tumor viruses can be classified into two groups based on their genetic material;~        1. DNA tumor viruses:~             1. Small DNA tumor viruses (Papilloma viruses, Polyoma viruses and adenoviruses).~             2. Complex DNA tumor viruses (Herpes viruses and Hepatitis B viruses).~        2. RNA tumor viruses ( Hepatitis C viruses and human T-cell leukemia virus HTLV).~      There are around 100 types of HPV, with different variations in their genetic and oncogenic~     potential [5]. Thus, HPV genotypes are divided into 2 groups based on their vulnerability;~     High risk HPV (HR-HPV) and low risk HPV (LR-HPV).~      The HPV genome encodes several oncoproteins [5]. E6 and E7 are the main genes responsible for~     cell transformation mediated by HR-HPV, and they modulate the activities of cellular proteins~     that regulate the cell cycle. Thus, the presence of E6/E7 can be a specific marker for~     diagnosing precancerous lesions by HPV.~      Knowledge of the etiology of virus-mediated carcinogenesis, the networking of pathways~     involved in the transition from infection to cancer and the risk factors associated with each~     type of cancer, all suggest prophylactic and therapeutic strategies that may reduce the risk~     of virus-mediated cancer.~   "
28931|NCT03188302|"~     This study is designed to validate a new direct method for the measurement of stool~     consistency, using Texture Analyser. Forty healthy subjects are enrolled in this trial for~     collection of stool samples. Every stool produced during 2 collection periods of~     approximately 60 hours each is collected and subjected to the measurement of consistency~     using Texture Analyser. The stool consistency results are compared with the Bristol Stool~     Form Scale scores for each stool. The relationships of stool consistency with other stool~     parameters, bowel habit and sleeping habit are also evaluated.~   "
28932|NCT03188289|"~     This is a randomized clinical trial in which investigators will compare the antimicrobial~     effect and inducer of cicatrization as well as the degree of postoperative pain in patients~     who are extracted the lower third molars.~      After the surgery, different bioadhesive gels will be applied in the area of the surgical~     wound and we will evaluate the aforementioned parameters.~   "
28933|NCT03188276|"~     Hepatitis C virus (HCV) infection is easy to chronic and can progress to cirrhosis and liver~     cancer. Direct-acting antiviral treatment can significantly improve the prognosis of the~     disease and the efficacy is seemingly not affected by a variety of viral factors. In~     addition, direct-acting antiviral agents therapy may affect the transformation of the immune~     cells and ameliorate the host immune status consequently. This study mainly investigated the~     relationship between Direct Acting Antiviral Treatment effect and the functional activity of~     myeloid-derived suppressor cells (MDSCs) and natural killer cells (NK cells) in Chronic~     Hepatitis C.~   "
28934|NCT03188263|"~     The primary purpose of this pilot study is to test a novel head worn light device (Re-Timer®)~     as an intervention to improve glucose metabolism in people with prediabetes. The hypothesis~     is that morning light treatment will improve glucose metabolism. This is a pilot study and~     the data from this project will be used to develop a larger clinical trial.~   "
28935|NCT03188250|"~     Preventing maternal and newborn deaths remain high on the global agenda. To address this, the~     Academic Model Providing Access to Healthcare (AMPATH), in partnership with the Government of~     Kenya, launched Chama cha MamaToto, a community-led peer-support model that groups women~     together in pregnancy and infancy. Central to the chama approach is the integration of~     health, social and financial literacy education with a savings/loans program.~   "
28936|NCT03188237|"~     This proposal is a program evaluation of a group care delivery model designed for pregnant~     women that was implemented as a pilot project in Teso District, Kenya in 2012.~   "
28937|NCT03188224|"~     Moving from child care to adult care is a hard time for patients and their families. Parents~     of children with chronic conditions say they need more support around the time of changing~     care. Care providers say they do not have the tools to provide smooth transitions or help~     their patients manage their own health. This study is to see if a smart-phone-based app~     (named MyTransition) can improve healthcare transition experiences and health outcomes for~     youth, compared to usual care.~   "
28938|NCT03188211|"~     Atrial Fibrillation (AF) is the most common cardiac arrhythmia and the main cause of~     cardioembolic stroke. Oral Anticoagulation (OAC) has been shown to significantly prevent~     AF-related thromboembolism, however, despite convincing evidences and current guidelines~     recommendations, OAC tends to be underused in clinical practice especially in the oldest.~     Education and training to appropriately select people suitable for OAC for stroke prevention~     could be pivotal in the decision making process. According to the study project, physicians~     working in Internal Medicine and Geriatric wards, where are mainly admitted elderly people~     with AF, will undergo to a program of e-learning through computer-based simulation method~     reproducing clinical scenarios of patients aged 65 years or older, with known or newly~     diagnosed AF, admitted to hospital for any medical reason and requesting that a decision~     about long-term antithrombotic therapy is taken.~      Primary objective of the study is to investigate whether such educational intervention will~     improve the appropriate use and prescription rate of OAC in hospitalised elderly patients~     with AF, multimorbidity and polypharmacy, in comparison to the usual practice.~      The study will be a cluster randomised controlled trial involving a network of Internal~     Medicine and Geriatrics wards. Thirty-two wards will be recruited based on voluntary~     participation and randomised to receive an educational intervention through computer-based~     simulation, (N=16) or to continue with the usual practice (N=16). Subjects receiving the~     intervention will be all the staff physicians of the wards randomised in the intervention~     arm.~      The impact of the intervention compared with the usual practice will be evaluated in patients~     aged 65 years or older admitted to the participating centres with a known diagnosis of AF or~     newly diagnosed with AF during the hospitalisation.~   "
28939|NCT03188198|"~     This randomized phase II trial is studying two different combination chemotherapy regimens to~     compare how well they work in treating patients with diffuse large B-cell lymphoma.~   "
28940|NCT03188185|"~     This study will evaluate the efficacy, safety, and tolerability of adjunctive ALKS 5461 in~     adults who have treatment refractory MDD.~   "
28941|NCT03188172|"~     To determine whether a combination of four novel agents bortezomib(Velcade), lenalidomide~     (Revlimid), Daratumumab (Darzalex) & dexamethasone in combination with low-dose~     cyclophosphamide is sufficiently active in a high risk population of myeloma patients, to~     take forward into a phase III trial compared to standard treatment.~   "
28946|NCT03188107|"~     The aim of this study is to assess risky infants (or diagnosed infants) with Infant Motor~     Profile, and analyze interrater and intrarater reliability of this test.~   "
28949|NCT03188068|"~     Kaposiform hemangioendothelioma (KHE) is a rare vascular neoplasm that occurs predominantly~     in infancy or early childhood. KHE has a nearly equal sex ratio. The annual incidence of KHE~     has been estimated at 0.071 per 100,000 children. KHE presents with intermediate-malignant~     and locally aggressive characteristics but without distant metastases.~      This pilot trial studies sirolimus versus sirolimus plus pednisolone in treating patients~     diagnosed with kaposiform hemangioendothelioma (KHE) and Kasabach-Merritt phenomemon (KMP)~     that cannot be removed by surgery. The purpose of this study is to compare the efficacy and~     safety of orally administered sirolimus versus sirolimus plus pednisolone in the treatment of~     KHE associated with KMP.~   "
28950|NCT03188055|"~     The purpose of this study is to test the effect of the Best Case/Worse Case (BC/WC)~     communication tool on the quality of communication with older patients admitted to two trauma~     units. The intervention was developed and tested with acute care surgical patients at the~     University of Wisconsin (UW) and we are now testing whether the intervention will work in a~     different setting. We will test the intervention with severely injured older adults at Oregon~     Health Sciences University (OHSU) and Parkland Memorial Hospital (PMH) at the University of~     Texas Southwestern (UTS). In the first year, UTS/PMH and OHSU will recruit and enroll 50~     patients in the control arm (total, for both sites) and train trauma surgeons to use the best~     case/worst case tool. In the second year, UTS/PMH and OHSU will recruit and enroll 50~     patients in the intervention arm (total, for both sites). UW will compare survey-reported and~     chart-derived measures before and after clinicians learn to use the best case/worst case~     tool.~   "
28951|NCT03188042|"~     This pilot study will test the preliminary efficacy and feasibility of an intervention~     protocol for one method of electric current stimulation, repetitive transorbital alternating~     current stimulation (rtACS), to treat visual impairment in people with glaucoma. We will~     evaluate a study protocol to use in future clinical trials to test the effectiveness of rtACS~     to ameliorate the progressive effects of vision loss both structurally and functionally in~     the eye, the visual pathway, and in regard to people's independence (i.e., functional~     ability). In this prospective, randomized controlled, double-masked pilot study, we will: 1)~     determine an effect of rtACS on ophthalmic structure and function (from retina to visual~     brain), 2) assess the methodology of procedures for assessment of people's functional ability~     and QoL to determine an effect of rtACS, and 3) assess the feasibility and implementation of~     the pilot study protocol for a larger multi-site, randomized controlled trial.~   "
28952|NCT03188029|"~     The aim of this study is to investigate the effect of repeated doses of etomidate on the~     adrenocortical synthesis of corticosteroids in patients aged 18 to 65, ASA status I to III~     scheduled to electroconvulsive therapy every 2 days for 3 to 4 weeks.~      Anesthesia protocol is standardized with 0.5 mg/kg propofol, 0.3 mg/kg etomidate and 0.5~     mg/kg succinylcholine.~      Blood samples for cortisol dosage are performed immediately before the first session~     (baseline cortisol), 24 hours after the first session, 24 hours after the third session and~     24 hours after the sixth session. All blood samples are performed at 9 and collected in~     normal tube.~      sample were analysed using the Electrochimiluminescence ECLIA -Cobas - Roche. The normal~     value are between 6.2-19.4 µg/dL . Sample analysis was performed by a biochemist blinded to~     clinical detail.~   "
28953|NCT03188016|"~     The project will investigate the effectiveness of a specialised musical-clinical approach~     used as an adjunct to an established non-musical intervention in the enhancement of~     interpersonal interaction.~      6 school pupils with profound disability will be randomly allocated to experimental and~     control groups. The control group will receive only Intensive Interaction for 16 sessions.~     The experimental group will receive four sessions of Intensive Interaction, followed by~     twelve sessions of Intensive Interaction plus improvised music. Music therapists will follow~     a flexible manual written to ensure that their music supports the interaction between pupil~     and learning support assistant (LSA) without direct social interaction with either.~      Changes in capacity for interpersonal interaction will be assessed by a standardised~     assessment instrument, the Pre-Verbal Communication Schedule (PVCS), administered to both~     experimental and control groups before the 1st session and after the 16th session.~      There will also be a qualitative process study of the experimental group conducted by video~     observation by the researchers involved.~      The project is funded in equal shares by the Music Therapy Charity and Beacon Hill Academy.~   "
28954|NCT03188003|"~     Lumbar pain is one of the most common injuries being the cause of morbidity in the individual~     generating occupational disability with strong personal, social and economic impact. As one~     of the methods of treatment, Pilates is a method that has good results for the management of~     this dysfunction. However, it is not known exactly which approach Pilates can bring better~     results for this population. Therefore, the purpose of this study is to compare the effects~     of two types of Pilates method interventions on non-specific chronic low back pain.~      A blinded randomized clinical trial, will be held. 28 patients divided randomly into two~     groups will be assessed, the Mobilization Pilates (MP) and the Stabilization Pilates (SP).~     Both groups will be formed by individuals of both sexes and aged 21 to 41 years with chronic~     low back pain. Both groups will receive 10 sessions of Pilates Methods twice a week, with~     each session taking an average of 50 minutes, therefore the MP will focus on a lumbo-pelvic~     mobilization exercises approach and the SP will focus on lumbo-pelvic stabilization exercises~     approach. At the beginning and end of the 5 weeks the individuals are evaluated to verify the~     presence of pain and disability with VAS of pain and Oswestry Questionnaire, and also with~     the Functional Movement Screen. Data will be analyzed statistically.~   "
28955|NCT03187990|"~     In 22% of patients with elevated Prostate-specific antigen (PSA) MRI guided biopsy will not~     detect significant prostate cancer (PCA) (defined as either: Gleason score (GS) ≥ 3+4 or~     tertiary pattern 5, or final stage ≥ pT3a and/or pN1). Therefore this study evaluates the~     ability of [68Ga]PSMA PET/MRI to detect and localize significant primary PCA to accurately~     direct prostate needle biopsy using the Gleason score from the histology of the core biopsies~     as standard of truth.~   "
28966|NCT03187847|"~     The primary objective is to evaluate changes in fatigue and physical activity (step counts)~     before and after rehabilitation in patients with MS (EDSS 3-6.5).~      The association of changes in fatigue and physical activity will also be analyzed for disease~     severity (EDSS), age, emotional status (depression) of the participants.~   "
28956|NCT03187977|"~     Computer-based cognitive training has been found to be helpful for improving attention and~     working memory in pediatric and adult patients with existing cognitive difficulties. A~     previous study was conducted at St. Jude Children's Research Hospital with survivors of~     childhood cancer who were experiencing difficulties with attention and/or working memory.~     Findings from that study indicated that the use of Cogmed, computer-based cognitive training,~     is effective in improving attention and working memory in survivors.~      Researchers want to learn whether Cogmed intervention completed at the end of therapy for~     acute lymphoblastic leukemia will be effective for all survivors (i.e., regardless of whether~     they have existing difficulties).~      PRIMARY OBJECTIVES:~        -  To evaluate the overall participation rate in a randomized, standard-of-care controlled~          trial of computerized cognitive intervention administered at the end of TOTXVI therapy.~        -  To estimate the study completion rate in a randomized, standard-of-care controlled trial~          of computerized cognitive intervention administered at the end of TOTXVI therapy.~        -  To estimate the compliance rate for participants randomized to the intervention arm of a~          computerized cognitive intervention administered at the end of TOTXVI therapy.~        -  To estimate the standard deviation for the overall cohort on a measure of working~          memory.~        -  To use neuroimaging data collected in the context of the Total Therapy XVI trial to~          explore candidate biomarkers predictive of response to the computerized cognitive~          intervention.~   "
28957|NCT03187964|"~     TB is increasingly diagnosed using the GeneXpert platform, which can be used for a variety of~     tests (not just TB). HIV viral load monitoring is required at least annually in patients on~     ART to detect failure of virologic suppression, however, most HIV VL testing is done in a~     central lab. If a patient has virologic failure, these patients are more likely to get TB.~      The investigators wish to see if Xpert done at the clinic results in faster patient TB~     diagnosis and treatment initiation compared to sending specimens away to a central~     laboratory. In a different patient group (PLHIV returning for HIV treatment monitoring), the~     investigators wish to see if POC Xpert HIV-1 viral load (Xpert VL) monitoring results in~     faster patient viral load quantification compared to sending patient specimens to a~     centralised laboratory. Both POC tests will use the same testing hardware. This polyvalent~     utility of the GeneXpert system is hitherto uninvestigated in this local setting.~      Newly diagnosed pre-ART HIV positive patients will be approached and asked to be a part of~     this study. Patients will be randomly assigned to Ultra done at the clinic or the normal~     off-site laboratory TB testing. The time taken for patients to get diagnosed and how long it~     takes to start treatment will be recorded. Additionally, a different group of HIV positive~     patients (on ART) returning to the clinic for annual follow-up visits will also be asked to~     join the study. These patients will be randomly selected for either Xpert VL testing done at~     the clinic or the normal off-site laboratory VL testing. The time taken for patients to~     receive viral load results will be recorded. The time taken for patients to have ART regimen~     adjusted, receive adherence counselling or received HIV drug susceptibility testing will be~     recorded should the patient's viral loads be found to be higher than anticipated and~     considered by the clinical to indicate a lack of viral suppression.~      This project will confirm if Ultra TB testing performs well in PLHIV irrespective of~     symptoms, and may produce evidence that supports universal TB testing in this important and~     vulnerable patient group. The investigators will also assess whether POC placement of Ultra~     and Xpert VL has benefits (e.g., more patients diagnosed for TB or VL monitored during the~     same day visit).~   "
28958|NCT03187951|"~     Any time the words you, your, I, or me appear, it is meant to apply to the potential~     participant.~      The goal of this clinical research study is to learn if regular exercise and behavioral~     skills training can help to improve physical activity in patients with pancreatic cancer who~     are scheduled to receive chemotherapy and/or radiation before standard-of-care surgery.~      This is an investigational study.~      Up to 128 participants will be enrolled on this study. All will take part at MD Anderson.~   "
28959|NCT03187938|"~     Alkaline phosphatase is known to be produced by syncytiotrophoblasts in the placenta and its~     levels are normally increased in pregnancy. Therefore, it would be reasonable to hypothesize~     that alkaline phosphatase would be low to low normal in cases of low birth weight /~     intrauterine growth restriction (IUGR)/ placental insufficiency.~   "
28960|NCT03187925|"~     Patients undergoing open transcervical or endoscopic approach in which a laser or stapler is~     used to divide the common wall between the diverticulum and esophagus, or who are not~     surgical candidates but agree to follow-up.~   "
28961|NCT03187912|"~     Following the Bunsen-Roscoe law, accelerated cross-linking protocols with higher irradiation~     intensities and shorter irradiation times have been introduced. In addition, new riboflavin~     solutions with HPMC (hydroxylpropyl methylcellulose) instead of dextran found its way into~     CXL-treatment. The aim of this trial is to evaluate clinical outcomes in an accelerated~     corneal collagen cross-linking protocol with different riboflavin solutions.~   "
28962|NCT03187899|"~     The goal of the study is to determine if the addition of a superficial cervical plexus block~     to a traditional interscalene plexus block will provide superior perioperative analgesia to~     an interscalene brachial plexus blockade alone for repair of clavicle fractures and~     non-/malunions.~   "
28963|NCT03187886|"~     INTRODUCTION: Cerebral amyloid angiopathy-related inflammation (CAA-ri) is a very rare~     manifestation of cerebral amyloid angiopathy, characterized by acute/subacute neurological~     deterioration and T2/FLAIR corticosubcortical or deep white matter hyperintensity. With the~     advent of new diagnostic criteria, there are more and more case reports and series reported;~     nevertheless, MRI findings and follow-up data need to be thoroughly described.~      OBJECTIVES: Our aim in this multicentrical and retrospective study was to describe the~     clinical and radiological features of patients with CAA-ri and assess long-term prognosis.~      METHODS: We reviewed the characteristics of 28 patients with CAA-ri including clinical data,~     systematic MRI analysis, cerebrospinal fluid results (including Alzheimer's disease~     biomarkers) and APOE genotype.~      HYPOTHESIS: We aimed at describing the clinical and radiological characteristics of a cohort~     of patients with CAA-ri.~   "
28964|NCT03187873|"~     This team has shown that chamas can be tailored to increase the uptake of health services in~     pregnancy and infancy, sustain themselves beyond the period of funding and become integrated~     within a county's health strategy. However, further investment is warranted to validate this~     intervention in a new region to ensure the positive effects on MNCH are a result of chamas~     and can be replicated. The purpose of this study is to demonstrate that chamas are an~     effective service-delivery platform for improving women's and children's health and~     well-being in western Kenya.~   "
28965|NCT03187860|"~     This is a prospective study comparing 4 groups: (1) non-smoking controls, (2) smokers without~     chronic obstructive pulmonary disease (COPD), (3) smokers with COPD, (4) severe asthma.~      Bronchial biopsy specimens from each subject will be obtained to produce air-liquid-interface~     cell cultures. These will then be used to make observations concerning cilia and mucus~     rheology.~      This is a first pilot study. The working hypothesis is that the largest group differences~     will be found for cilia densities; the latter metric was thus chosen as a primary criterion.~   "
28967|NCT03187834|"~     The use of antibiotics has saved millions of human lives, however consumption of antibiotics~     can select for antibiotic resistant organisms and may lead to changes in commensal~     microbiome. This study is designed to estimate the effect of antibiotic consumption on~     microbiome in a rural region of rural Burkina Faso. Changes in the intestinal and~     nasopharyngeal microbiome and resistome following a short course of antibiotics will be~     measured.~   "
28968|NCT03187821|"~     The purpose of this study is to determine if location of laser peripheral iridotomy (LPI)~     that is the standard of care treatment for angle closure glaucoma is related to changes in~     post-operative intraocular pressure (IOP), endothelial cell count,anterior chamber angle~     morphology and onset of new visual disturbances.~   "
28969|NCT03187808|"~     This study aims to compare the immediate effects of using a single thoracic manipulation~     combined with special massage technique (RT technique) and single thoracic manipulation alone~     on pain level at rest, cervical range of motion, upper limb neurodynamic test, neck~     disability, and adverse effects in chronic mechanical neck pain patients.~   "
28970|NCT03187795|"~     The purpose of this research study is to determine the effectiveness and safety of mirabegron~     compared to oxybutynin chloride immediate release (oxybutynin IR) for a condition called~     neurogenic detrusor overactivity in individuals with chronic spinal cord injury (SCI).~   "
28971|NCT03187782|"~     The mechanism led to the dysmenorrhea can be understood more clearly and one may have a~     better idea to treat the disease in the future.~   "
28972|NCT03187769|"~     This study will evaluate the effect of ALKS 3831 compared to olanzapine on body weight in~     young adults with schizophrenia, schizophreniform, or bipolar I disorder who are early in~     their illness~   "
28973|NCT03187756|"~     This is an open label phase II single arm study of peripheral blood stem cell transplantation~     and posttransplantation cyclophosphamide, using HLA full match or haploidentical related~     donors, in hematological malignancies including those difficult to engraft. The objective of~     this study is to evaluate the safety and feasibility in nonmyeloablative, partially~     HLA-mismatched or HLA-matched PBSC transplant from haploidentical donors or fully matched~     donors with post-grafting immunosuppression that includes high-dose cyclophosphamide,~     tacrolimus, and Mycophenolate mofetil (MMF).~   "
28974|NCT03187743|"~     This research study is a multicentre prospective pharmacokinetic study. The clinical and~     biological data will be collected in the framework of a prospective study. The drug to be~     evaluated is a glucocorticoid routinely used to treat Systemic lupus erythematosus (SLE)~     patient. Initial dose of prednisone must be oral and at least 0.5mg/Kg/day, but the precise~     dosage and the tapering regimen will be determined according to the clinical judgment of the~     investigator. The duration of the research period for each patient will be 3 months. Three~     visits (which are all usual care visits) will be needed within the 3 months of the study for~     collecting data and/or blood sampling~   "
28975|NCT03187730|"~     This is a 24 month pilot project that will implement and evaluate an innovative program that~     integrates financial counseling with smoking cessation counseling for low-income immigrants.~   "
28976|NCT03187717|"~     The aim of us is to define the incidence of postoperative complications and recovery time in~     view of two anesthesia procedures.~      During the period between 01.01.2016 and 01.01.2017, totally 583 patients were included in~     the study, who had oral and maxillofacial surgeries. Anesthesia types were determined as~     total intravenous anesthesia (TIVA) and inhalation anesthesia (IA). Postoperative~     complications and recovery period were determined as tachycardia, bradycardia, hypertension,~     hypotension, recovery time, additional analgesia, nausea-vomiting. Both anesthesia procedures~     were compared in terms of these postoperative complications and recovery time.~   "
28977|NCT03187704|"~     The study is a blinded cross over test of in-home air filtration. Participants will have a~     window unit air filter (HEPA) installed that will filter for 3 weeks and do sham filtration~     for another 3 weeks. During the time that the filter is installed in the home a machine that~     measures particulate air pollution of the type that the filter is designed to remove will be~     installed. A survey will be administered, blood samples taken and blood pressure measured~     immediately prior to starting the filter, at 3 weeks when the filtration is changed from sham~     to real filtration or visa versa and at the end of the second three week period. All~     participants will be recruited from the Boston Puerto Rican Health Study cohort.~   "
28978|NCT03187691|"~     A Non-randomized, prospective , multicenter, open uncontrolled study in patients with acute~     myelogenous (AML) or lymphoblastic leukaemia (ALL)~   "
28979|NCT03187678|"~     The development of selexipag for intravenous administration will be useful to avoid treatment~     interruptions in patients with pulmonary arterial hypertension (PAH) already treated with~     selexipag administered orally as tablets (Uptravi®). The target population for intravenous~     selexipag includes those PAH patients who are hospitalized and are unable to swallow tablets~     of Uptravi.~      The primary objective of this study is to assess whether it is safe for patients with PAH to~     temporarily change from selexipag tablets (Uptravi®) to selexipag given directly into a vein~     (intravenous selexipag), and then switching back to the initial oral dose of selexipag.~   "
28980|NCT03187665|"~     This research study will help the investigators to learn more about a device used when~     children are sick called a pulse oximeter. The pulse oximeter measures how much oxygen is~     inside a child's blood without taking blood from the child. It is non-invasive meaning it~     does not enter the body. The device has a cable attached to it. At the end of the cable is a~     wrap that looks like a Band-Aid with a red light on it. This wrap is placed around a finger~     or toe. The red light gives the investigators a reading of how much oxygen is in the child's~     blood and the child's heart rate. Having a pulse oximeter connected to a child is painless.~     This device is used in many places. Besides hospitals, it is used in doctors' offices and in~     fitness centers.~      This study will help the investigators learn more about whether a partially wireless, more~     portable pulse oximeter that connects to a small device worn on the child's arm or leg will~     give the investigators a more reliable signal/reading while letting children move more~     easily. The investigators will compare this device with the traditional wall-connected unit.~     Movement of the cable or a child moving may give a false oxygen reading. The investigators~     will ask the child to do activities that create movement and will look at the readings when~     the child moves. The investigators think the partially wireless pulse oximeter will be more~     reliable during movement than the traditional wall-connected unit.~      Subjects will have two continuous pulse oximeter probes placed on them. These soft probes~     will go on a finger, toe, foot or hand and will be attached to two different pulse oximeter~     monitors. The child will then be asked to do common childhood activities based on their age~     for about 20 minutes. These activities will be play activities the child already does such as~     grabbing a toy, drawing with crayons or kicking a ball. Continuous pulse oximetry data will~     be recorded during the testing and will be stored in a way that it cannot be linked to the~     subject after the testing is complete.~   "
28981|NCT03187652|"~     A prospective cohort study of idiopathic TTP patients who have presented with their first~     episode and are in remission within the last 30 days. They will be followed for 12 months~     from the time of their remission, followed by a long-term follow up study.~   "
28985|NCT03187600|"~     The investigators want to compare two different surgical techniques for the treatment of a~     condition called velopharyngeal dysfunction (VPD). VPD is a condition in which the nasal part~     of the airway does not close properly during speaking and feeding. The current standard~     surgical management involves taking a pharyngeal flap from the back of the throat comprised~     of muscle and overlying mucosal tissue to create a functioning valve. The proposed technique~     would use only the mucosal/submucosal layer of the pharynx for the flap. This technique has~     been shown to be effective in animal models and it is hoped that it will lead to faster~     healing, lower complications and improved functional outcome for patients.~   "
28986|NCT03187587|"~     Thermotherapy is a technology aiming at destroying tissue, for example tumor tissue.~     Immunostimulating Interstitial Laser Thermotherapy (imILT) is a specific form of~     thermotherapy, which, in addition to destroying tumor tissue, has been optimized to cause a~     tumor specific immunologic response. In laboratory animals the imILT method has also been~     shown to induce a so called abscopal effect. This means that when one tumor is treated with~     imILT other, untreated, tumors also decrease in size.~      The purpose of this trial is to evaluate efficiency when it comes to local tumor destruction~     of the imILT treatment method performed pecutaneously in patients diagnosed with pancreatic~     cancer. The purpose is also to investigate the functionality and safety of the method.~      This trial is an open-label, double-arm study. Twenty patients diagnosed with pancreatic~     cancer will be treated in this trial, ten recieving imILT treatment and ten recieving~     standard chemotherapy. The study is estimated to be carried out during a time period of 21~     months.~   "
28987|NCT03187574|"~     Our study is a non-randomized prospective study compared two groups matched for~     anterior/apical POP-Q grade: 84 received Elevate Ant™ single-incision mesh (group A) and 42~     Perigee™ transvaginal mesh (group B). The study hypothesis was that the Elevate Ant™ mesh~     would provide better apical correction than the Perigee™ mesh. One- and 2-year follow-up~     comprised anatomic assessment (POP-Q) and QoL (PFDI-20, PFIQ-7, PISQ-12). Success was defined~     as 2-year POP-Q ≤1. Secondary endpoints were function and complications.~   "
28988|NCT03187561|"~     This 3-arm RCT tests the effects of a sleep-enhanced adaptation (FF+) of a well-known,~     evidence-based transition-to-parenting coparenting intervention program (Family Foundations;~     FF). In one arm, families will experience FF as originally formulated; in the second,~     families will receive an adapted FF (FF+) program that emphasizes coparenting in infant sleep~     contexts; the third arm will serve as controls. It is hypothesized that (1) Compared to~     controls, parents in both FF groups will report improved overall coparenting and reduced~     overall distress, but parents in the FF+ group will show greater improvements in coparenting~     and individual parenting in infant sleep contexts, better infant and parent sleep, and better~     child adjustment; (2) early coparenting around infant sleep will be a central mechanism by~     which both interventions exert their effects.~   "
28989|NCT03187548|"~     This study is aiming in preventing the formation of WSL associated with orthodontic treatment~     which occurs to more than 50% of orthodontically treated patients through applying CPP-ACP on~     the enamel surface once every 2 weeks for 3 months.~   "
28990|NCT03187535|"~     The proposed research will utilize electroacupuncture, a type of needleless acupuncture that~     uses electrostimulation, in a randomized, double blind study, to evaluate the incidence of~     post-operative nausea and vomiting (PONV) in patients undergoing spinal surgeries with the~     transcutaneous electrical acupoint stimulation (TEAS) compared to patients without TEAS.~   "
28991|NCT03187522|"~     This is an EU sponsored trial and independent of the US trial registered under~     Clinicaltrials.gov ID NCT02009644.~      The purpose of this registry is to gather clinical data on the safety and performance of the~     TREO Stent-Graft in patients with infrarenal abdominal aortic aneurysms. The registry is part~     of TREO's EU post-market surveillance plan providing long-term systematic clinical follow-up.~   "
28992|NCT03187509|"~     This study will be a randomized open-label pilot study. The purpose of the study is to~     compare standard of care outpatient heart failure management versus a weight based torsemide~     regimen. Subjects admitted to the hospital for heart failure exacerbation will be randomized~     upon discharge to either standard of care outpatient heart failure management or a weight~     based torsemide regimen. Those subjects randomized to standard of care therapy will be~     prescribed a daily fixed dose of a loop diuretic at hospital discharge and have a follow-up~     appointment within one week of discharge. All management decisions including loop diuretic~     type, dose and frequency will be made at the discretion of the subject's personal physician.~     Those randomized to an individualized weight based torsemide regimen will be prescribed a~     dose of torsemide upon hospital discharge based on a prespecified algorithm. These subjects~     will then undergo physician-subject phone encounters three times a week where the subject's~     torsemide dose will be modified based on the prespecified algorithm which incorporates~     current symptoms and weight. Primary end-point will be an unbiased estimate of 30-day all~     cause readmission rates. Secondary end-points include incidence of acute kidney injury,~     changes in brain natriuretic peptide levels from baseline and a preliminary estimate of the~     effect size and feasibility of a weight-based torsemide regimen intervention in order to plan~     a future larger study.~   "
28993|NCT03187496|"~     A non-randomized, multiple-dose, open-label, single sequence study to evaluate effect of~     concomitant administration of EDP-305 on the pharmacokinetics and safety of midazolam,~     caffeine, and rosuvastatin in healthy human volunteers.~   "
28994|NCT03187483|"~     This study aimed to compare flash-free bracket system with conventional adhesive-coated~     bracket system in patients with maxillary crowding.~   "
28995|NCT03187470|"~     Left ventricular dyssynchrony will be assessed by echocardiography using different~     programming of an implantable cardioverter defibrillator.~   "
28996|NCT03187457|"~     The study will assess vaginal microbiota levels before and after antibiotic treatment in~     females infected with Bacterial Vaginosis (BV).~   "
28997|NCT03187444|"~     Chronic inflammatory rheumatism and inflammation can increase the risk of cardiovascular~     problems. Indeed, these diseases can increase the risk of myocardial infarction. The~     objective of this project is a better understanding and preventing the risk of cardiovascular~     problems in chronic inflammatory rheumatism through the study on the long-term flexibility of~     the arteries, blood markers of cardiovascular risk and muscle mass.~   "
28998|NCT03187431|"~     Currently, the application status of MSCs as treatment modalities in IPF is still in its~     infancy and remains exploratory. Although a number of safety and efficacy clinical trials of~     MSCs as therapeutic options in immune-mediated and cardiac diseases have already been~     published with tantalizing results, to our disappointment, pulmonary and critical care~     medicine have traditionally lagged behind other therapeutic and research fields including~     hematology, gastroenterology and cardiology in translational studies of the use of reparative~     cells~   "
28999|NCT03187418|"~     The goal of this study is to evaluate the efficacy and safety of the novel form of~     trans-scleral cyclophotocoagulation using micropulse diode laser and trans-pars plana~     treatment (Micropulse TSCPC, mTSCPC MP3, IRIDEX CYCLO G6™ Glaucoma Laser System, CA, USA) in~     adults for the treatment of uncontrolled glaucoma.~   "
29000|NCT03187405|"~     Aneurysmal subarachnoid hemorrhage (SAH) is a devastating form of stroke, with delayed~     cerebral ischemia (DCI) as a major complication. There are several evidences, both in~     preclinical and in clinical studies that intraventricular fibrinolysis (IVF) controls the~     phenomenon that are leading to DCI. Here, the investigators propose to conduct a phase III~     trial to provide a clear evaluation of the impact of IVF after aneurysmal SAH.~   "
29001|NCT03187392|"~     The aim of our study is to compare the analgesic effect of topical application of~     lidocaine-prilocaine cream and lidocaine infiltration during insertion of birth control~     implants~   "
29002|NCT03187379|"~     This will be a comparative study between two cohorts of patients undergoing Roux-en-Y Gastric~     bypass. One cohort (75 patients) will receive FDA approved Exparel® (liposome bupivacaine~     injection solution) injections intra-operatively at time of incision site closure. The~     control cohort (75 patients) will receive 0.25% bupivacaine injection solution at the time of~     incision site closure. The medication for the control group is our current standard of care.~     The primary end point is post-operative pain at 24 and 48 hours measured by the Visual Analog~     Scale (VAS). Comparison will be made between cohorts. All subjects enrolled in the study will~     be evaluated per nursing protocol with the verbal numerical analog scale. At 24 and 48 hours~     a member of the research team will administer a 2-part questionnaire containing the VAS and~     the Revised American Pain Society Post-Operative Questionnaire (APS-POQ-R). The latter is~     validated for assessment of the patient's experience of pain and it hindrance to daily~     activity in the post operative period.~   "
29003|NCT03187366|"~     Schistosomiasis is a flatworm transmitted from freshwater snails to humans in the tropics. In~     addition to this infectious disease, tropical developing countries are faced with~     malnutrition. We propose to alter pesticide and compost use to reduce schistosomiasis and~     maintain or even improve crop production.~   "
29004|NCT03187353|"~     This is a double-blind, placebo-controlled, crossover study testing whether Vyvanse~     (lisdexamfetamine; LDX) improves executive functioning (EF) in 100 postmenopausal women who~     report onset of EF difficulties after oophorectomy. This study involves magnetic resonance~     imaging (MRI) to see how LDX affects brain chemistry while undergoing two 6-week trials of~     the study drug and placebo capsules.~   "
29005|NCT03187340|"~     Insomnia can be a chronic problem that leads to significant daytime fatigue, stress and~     numerous negative health consequences including depression. Advanced Medical Electronics, in~     partnership with researchers are the University of Pennsylvania, propose developing an~     innovative, non-drug, low-risk, intervention that can be implemented on mobile devices for~     the treatment of insomnia~   "
29006|NCT03187327|"~     In this prospective study, patients who underwent vaginal hysterectomy with salpingectomy or~     salpingo-oophorectomy were included. The objective of this study is to assess the feasibility~     of prophylactic salpingectomy during vaginal hysterectomy for benign pathology and the~     prevalence of occult tubal lesions. The hypothesis is that prophylactic salpingectomy during~     vaginal hysterectomy for benign pathology present a low failure rate and it makes it possible~     to avoid the appearance of a certain number of ovarian cancers. The prevalence of bilateral~     salpingectomy with or without ovariectomy and the prevalence of histopathological and~     immunohistochemical (p53 expression) abnormalities were evaluated.~   "
29007|NCT03187314|"~     The objective of this study is to evaluate the efficacy and safety of radiation therapy~     combined with anti-PD-1 antibody SHR-1210 in patients with esophageal cancer~   "
29008|NCT03187301|"~     A cardiac safety study of an investigational drug to see how it affects the heart in people~     with Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes)~   "
29009|NCT03187288|"~     This is a phase 1 study of investigational drug CFI-400945 in patients with relapsed or~     refractory acute myeloid leukemia or myelodysplastic syndrome. The purpose of this phase 1~     study is to see how safe and tolerable the study drug is and to determine the best dose~     (maximum tolerated dose or recommended phase 2 dose) that can be given in this patient~     population.~   "
29010|NCT03187275|"~     Cancer-related fatigue (CRF) is a prevalent and debilitating symptom experienced by cancer~     survivors. CRF can persist for months or years after cancer therapy is completed and has a~     negative impact on all areas of mental and physical function. Treatment options for CRF are~     extremely limited and finding safe, inexpensive, and effective interventions for managing~     this distressing symptom are urgently needed. Massage therapy is one of the fastest growing~     complementary therapies. A recently completed study in breast cancer survivors with CRF found~     that Swedish Massage Therapy (SMT) caused a significant reduction in fatigue and improvement~     in quality of life. This study investigates the effects of massage therapy on CRF among~     prostate cancer survivors. The study will evaluate whether SMT improves quality of life,~     depression, and anxiety. Second, this study will evaluate if SMT reduces CRF by decreasing~     the pro-inflammatory cytokine Interleukin-6 (IL-6). Lastly, to establish measures of reduced~     fatigue beyond self report at the treatment visits, the researchers will implement~     continuous, real-time monitoring of physiologic and psychological signs and symptoms,~     throughout the treatment period. This study will improve care for CRF and other~     hard-to-manage symptoms of cancer treatment and provide preliminary evidence of immune~     modulation as a potential mechanism of action.~      This study is a randomized clinical trial to test the efficacy of Swedish massage therapy~     (SMT) versus an active control condition (light touch, LT) on cancer related fatigue in men~     with prostatic cancer, at least 2 months after the end of their radiation therapy and who are~     on androgen depletion therapy. The primary outcome is the Multidimensional Fatigue Inventory~     (MFI). Secondary outcomes are the Patient-Reported Outcomes Measurement System (PROMIS)~     Fatigue Scale, plasma concentrations of cytokine IL-6, self-reported quality of life,~     depression, and anxiety, wearable measures of activity and sleep, and Automated Monitoring of~     Symptom Severity (AMoSS) ratings.~   "
29011|NCT03187262|"~     This research study is studying Daratumumab as a possible treatment for Waldenström~     Macroglobulinemia.~   "
30645|NCT03165916|"~     A randomized prospective study will be conducted of patients at Vanderbilt University Medical~     Center who undergo liver transplantation from March 2014 until approximately 120 patients are~     randomized. Patients will be randomized to undergo biliary reconstruction with and without~     stent placement.~   "
29012|NCT03187249|"~     Anxiety and depression have negative effect on outcomes of chronic obstructive pulmonary~     disease (COPD). Intervention strategy including behavioral-cognitive therapy and pulmonary~     rehabilitation are promising in improving life quality, disease symptom and outcomes. But~     there's not standard algorithm in China so far. The study aims to compare the effectiveness~     of these interventions and develop an intervention algorithm of anxiety and depression in~     COPD.~   "
29013|NCT03187236|"~     Anxiety and depression are common comorbidities of chronic obstructive pulmonary disease~     (COPD). However, the exact prevalence is not known in China. COPD patients with anxiety and~     depression tend to have more severe symptoms and worse prognosis, but the related evidences~     are not strong enough. The study aim to investigate the prevalence and long-term outcome of~     anxiety and depression in COPD.~   "
29014|NCT03187223|"~     Two high-dose chemotherapy regimens (melphalan alone versus the combination of melphalan and~     bendamustine) used for conditioning treatment before autologous stem cell transplantation~     will be compared in a 1:1 randomization in myeloma patients. The experimental arm is the~     bendamustine and melphalan (BenMel) combined regimen. The melphalan alone (Mel) regimen is~     the control (standard) treatment. Despite remarkable progress using novel agents both for~     induction before ASCT as well for maintenance after ASCT, definite cure in myeloma patients~     remains exceptional due to residual disease escaping intensive treatment. The aim of the~     study is to show an improvement of the rate of complete Remission 60 days after ASCT in~     myeloma patients from 50% with melphalan alone to 65% with the combination of bendamustine~     and melphalan.~   "
29015|NCT03187210|"~     The trial assess the maximum tolerated dose of a single-dose of Brentuximab Vedotin added to~     standard BeEAM chemotherapy (comprising Bendamustin, Etoposide, Cyclophosphamide and~     Melphalan) before autologous stem cell transplantation in CD30+ malignant lymphomas.~   "
29016|NCT03187197|"~     To describe the treatment perception from patients with non-valvular atrial fibrillation~     (NVAF) receiving Pradaxa® or VKA for stroke prevention by using the self-estimation~     questionnaire of PACT-Q during a 6-month study period.~   "
29017|NCT03187184|"~     Pharmacogenomics (PGx) studies the interactions between an individuals genes and medications.~     PGx testing identifies genes within an individual that may affect treatment, efficacy, and~     toxicity of drugs. With improvements in testing speed, accuracy and cost, it is now possible~     to perform PGx testing in cancer patients prior to starting chemotherapy. The test results~     may help a physician personalize chemotherapy dosing. The goal of this study is to determine~     if PGx testing using the OneOme® Rightmed test is feasible in a community oncology clinic to~     guide treatment prior to starting chemotherapy. The study will also gather data regarding the~     frequency of genes within the local population as well as the impact of testing on~     chemotherapy doses.~   "
29018|NCT03187171|"~     This research protocol seeks to compare radiological and clinical outcomes of cervical spine~     disease patients following standard-of-care anterior cervical discectomy and fusion (ACDF)~     using allograft fusion versus Cohere porous polyetheretherketone (PEEK) fusion device.~      This clinical study presents little to no additional risk to study subjects beyond those~     associated with standard-of-care ACDF surgery. Adults age 18 and over who are undergoing an~     ACDF procedure will be enrolled in the study. The study consists of a completing a series of~     questionnaires and obtaining radiographs. The primary endpoint of the study will be the rate~     of successful spinal fusion for each group. For evaluation of the primary endpoint and~     additional assessments, descriptive statistics including mean, standard deviation, minimum,~     median, and maximum for continuous variables and frequency distribution for categorical~     variables will be provided, as well as tabular listings. All complications will be itemized~     including incidence, duration, and relationship to the device used and/or procedures~     performed.~   "
29019|NCT03187158|"~     Attainment of peak healthy lung function during the 18-26 yr window is a strong determinant~     of the rate of lung function decline during the later years of life. The attainment of a~     healthy peak lung function is mediated by pre and peri natal exposures ( in utero environment~     and nutrition) and exposure to environmental toxicants and nutrition during childhood and~     early adulthood. Towards this Indian birth cohorts, having collected comprehensive data on~     maternal nutrition and anthropometry can provide invaluable insight into the factors~     affecting lung function growth and their effect sizes in the Indian population. Therefore, in~     this observational study, the Investigator will be collecting data on lung function, current~     nutritional and environmental exposures and linking it to pre and peri natal data of the same~     participants in order to understand lung function growth and the reasons for an early decline~     in the Indian population, using a life course approach.~   "
29020|NCT03187145|"~     This is a prospective cohort study. The main objective is to compare the frequency of a full~     stomach in the diabetic population compared to healthy controls 2 h after clear liquid and~     6h after a light meal, and evaluate the mean gastric emptying time of clear liquid and light~     meal in diabetic patients.~   "
29021|NCT03187132|"~     This study will test the effectiveness of an evidence-based, multi-modal, digital~     pain-reduction kit as a non-pharmacological supplement to managing patients with acute pain~     due to orthopedic injuries. Outpatients will be randomized to receive either the pain~     reduction kit or an active control. The kit will contain a virtual reality (VR) headset,~     therapeutic VR visualization software, a low-cost wearable transcutaneous electrical nerve~     stimulation (TENS) unit, and a remote activity monitor. Clinical staff will monitor progress~     and provide scheduled coaching and outreach to patients in the intervention group. The~     control group will receive a remote activity monitor alone; they will not receive VR, TENS,~     or remote coaching. Study devices will be delivered to the patient's home with instructions~     for use; patients will receive remote clinical and technical support. Patients will be~     followed for 60 days and monitored for functional status, pain levels, use of pain~     medications (including opioids), satisfaction with care, and time to returning to work.~   "
29022|NCT03187119|"~     The aim of this study is to investigate the potential benefit of Pictorial versus Written~     Asthma Action Plans (AAPs) to support asthma management among young people with persistent~     asthma. Participants will be randomly allocated to the Pictorial or Written AAP group and~     followed up over a 6-month period. Qualitative and quantitative data will be collected from~     young people, parents and clinical teams involved in recruitment to assess the feasibility~     and acceptability of the Pictorial AAP (PAAP) software developed for this study, the PAAPs~     produced by the software, and the study procedures.~   "
29024|NCT03187093|"~     Major Depressive Disorder (MDD) is one of the most prevalent mental diagnosis within the~     worldwide population. Although there is evidence about relationship between MDD and cognitive~     dysfunction, still the correlations between biomarkers and the severity of the disorder or~     the level of cognitive dysfunction need further research. Therefore, the aim of the study is~     to determine such relationships in Ukrainian population.~   "
29025|NCT03187080|"~     Postoperative pain, nausea, and vomiting are frustrating sequelae of elective breast surgery.~     Poorly managed postoperative pain can lead to increased opioid use, increased postoperative~     nausea and vomiting (PONV), delayed return to work and usual activities, unplanned hospital~     admissions, surgical complications, and patient dissatisfaction. In light of the growing~     opioid epidemic in the United States, any intervention that potentially minimizes opioid use~     may have meaningful individual and societal impact. In patients undergoing breast reduction~     and breast augmentation surgery, multiple techniques for managing postoperative pain are used~     commonly. One such technique is the use of a paravertebral block (PVB), which is a method of~     injecting local anesthesia into the area surrounding the spinal nerves in order to decrease~     sensation and pain in the chests and breasts in the setting of breast surgery. PVB is~     generally used concomitantly with standard multimodal perioperative pain management including~     cool compress, non-steroidal anti-inflammatories (NSAIDs), acetaminophen, and opioids. All of~     these pain management strategies are used at the University of Wisconsin and are considered~     standard of care for breast surgery nationwide.~      The overall purpose of this study is to evaluate interventions that aim to optimize pain~     control, minimize the risk of PONV, and improve recovery after elective breast surgery. We~     will do this by (1) Comparing PVB with standard pain management strategies in patients~     undergoing planned breast reduction and breast augmentation, and (2) Comparing enhanced~     recovery after surgery (ERAS) strategies to standard of care for patients undergoing planned~     breast reduction and breast augmentation. This will be studied using pain assessments,~     validated surveys, medication logs, and review of medical records.~   "
29026|NCT03187067|"~     The purpose of this study is to evaluate the impact of LUS on the diagnosis and management of~     childhood pneumonia in developing countries~   "
29027|NCT03187054|"~     The objective of the Preoperative Pelvic Organ Prolapse Quantification (POPQ) versus~     Simulated Apical Support as a Guideline for Anterior or Posterior Repair at the Time of~     Transvaginal Apical Suspension (PREPARE) trial is to compare surgical outcomes of POPQ-based~     surgery with simulated apical support-based surgery for anterior or posterior vaginal wall~     prolapse at the time of transvaginal apical suspension.~   "
29028|NCT03187041|"~     Purpose: This research study seeks to determine whether surface pressures generated by~     elastic tourniquets used by phlebotomists during blood-draws can penetrate to deeper tissues~     where major arteries and nerves lie. Additionally, investigators will also determine the~     effects of prolonged tourniquet application on hand sensation using a controlled,~     reproducible force stimulus. In conjunction, the investigators will also track changes in~     skin surface pressures and pain levels over this prolonged tourniquet application.~     Hypothesis: The investigators hypothesize the use of common elastic tourniquets used for~     blood draws does not significantly impact sensation and will not elicit nerve or tissue~     damage. Technologies used: Monofilaments and Pressure Sensor~   "
29029|NCT03187028|"~     Determine feasibility of a randomized controlled trial (RCT) in pancreatic cancer patients~     comparing the effects of diet alone vs. diet+exercise on functional and clinical outcomes.~   "
29030|NCT03187015|"~     The purpose of this study is to evaluate the effect of Entinostat on the bioavailability of~     Midazolam.~      The primary objective is to evaluate the effect of a single oral dose of entinostat on the~     pharmacokinetics (PK) of a single oral dose of midazolam in healthy subjects.~      The secondary objective is to evaluate the safety and tolerability of combined administration~     of entinostat and midazolam in healthy subjects.~   "
29031|NCT03187002|"~     High-frequency, high-intensity transcutaneous electrical nerve-stimulation (TENS) is an~     inexpensive and non-invasive pain control approach. TENS, pulsating electrical currents that~     activate underlying nerves, does not have drug interactions or risk of overdose. Cochrane~     review of TENS for acute pain found inconclusive evidence. One previous abortion trial~     comparing TENS to IV sedation only looked at pain control in the recovery room. The~     investigators propose a randomized controlled trial comparing TENS to IV sedation (in~     conjunction with local anesthesia) among women presenting for first-trimester surgical~     abortion. Primary outcome will be perceived pain by Visual Analogue Scale (VAS) during~     cervical dilation.~   "
29032|NCT03186989|"~     The purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of~     IONIS-MAPTRx in patients with Mild Alzheimer's Disease~   "
29033|NCT03186976|"~     This is a pilot study to assess feasibility to conduct a multi-center, randomized trial to~     examine the effect of aggressive risk factor control and arrhythmia trigger-based~     intervention on the atrial substrate, which is involved in the development and maintenance of~     atrial fibrillation (AF).~   "
29034|NCT03186963|"~     The purpose of this study is to determine wether postoperative immobilization is effective in~     controlling the pain of patients with intra-articular distal radius fractures treated with~     volar locking plate fixation. The study hypotheses is that postoperative immobilization does~     not enhance the analgesia of these patients.~   "
29072|NCT03186469|"~     Teen mothers present a unique set of challenges in reducing the risk for sleep-related infant~     mortality, in part because they may not be the sole decision-maker for an infant's sleep~     environment and position and they make seek advice from older female support people.~     Investigators will conduct a randomized controlled trial of a educational intervention to~     mitigate the risks of unsafe infant sleep practices across generations. Given the complexity~     and variability of teen-SCG relationships, investigators will include an examination of~     inter- and intra-personal factors that are key control variables or may mediate the uptake of~     safe sleep recommendations. Investigators believe that the intervention will empower support~     people to positively influence a teen mother's adoption of safe sleep recommendations.~   "
29073|NCT03186456|"~     The purposes of the study is to determine the safety and efficacy of treating acute ischemic~     stroke patients with human umbilical cord mesenchymal stem cells (hUC-MSC).~   "
29074|NCT03186443|"~     Pregabalin is effective on herpetic neuralgia, but whether can prevention post-herpetic~     neuralgia still need to confirm.~   "
29035|NCT03186950|"~     The pulp therapy in primary teeth is designed to eliminate the infection and keep the tooth~     in a functional state until its natural exfoliation. An important step for the success of~     endodontic therapy is the final restoration, which must seal the tooth, avoiding new~     contamination. Thus, this study proposes to carry out a randomized clinical trial with~     longitudinal follow-up of two years, in order to compare the degree of success of endodontic~     treatment in primary teeth restored with two different techniques: composite resin (Filtek~     Bulk Fill - 3M ESPE) or stainless steel crowns (3M ESPE). Success will be measured by~     clinical and radiographic features of primary teeth treated with the different restorations~     after 1, 6, 12 and 24 months. Among the secondary outcomes that will be assessed are the~     quality and durability of restorations and the cost benefit of treatments. Patients who seek~     the university clinics and require endodontic treatment will be invited to participate. The~     sample unit is the tooth and these will be randomized in groups through a randomization list~     created and distributed in sequential opaque envelopes. The envelope will be opened only~     after the end of endodontic treatment, to ensure allocation concealment. The data will be~     statistically analyzed using the Stata 12.0 (Stata Corporation, College Station, TX, USA).~     The longevity of the treatments will be evaluated by estimating survival rates using the~     Kaplan-Meier method. Differences between survival rates according to the type of endodontic~     proposed treatment will be analyzed using the log-rank test. All other clinical variables~     will be analized using Cox regression. The significance level for all analyzes will be 5%.~   "
29036|NCT03186937|"~     Given preliminary data demonstrating that methionine deprivation enhances cell surface~     expression of TRAIL receptor-2, the objective of this clinical trial is to confirm that~     methionine restriction enhances its expression in triple negative breast cancer and to~     establish the feasibility and acceptability of this dietary intervention in humans. This~     study will also examine the effect of methionine restriction on cancer stem cells and~     metabolic health.~   "
29037|NCT03186924|"~     This research program aims to comprehensively investigate the clinical, physiological,~     metabolic, and molecular effects of reducing sedentary behavior in rheumatoid arthritis. This~     4-month parallel-group randomized controlled trial aims to investigate the feasibility and~     efficacy of a newly developed personalized intervention focused on replacing sedentary time~     with light-(or very light-) intensity physical activity in rheumatoid arthritis. A multitude~     of gold-standard techniques will be applied to evaluate the effects of the intervention on~     several outcomes, including sedentary time (primary outcome), physical activity levels,~     clinical parameters specific to each condition, cardiometabolic risk factors, immune~     function, and health-related quality of life. In addition, skeletal muscle and blood samples~     will be collected and a variety of molecular analyses will be performed to gather knowledge~     on the potential mechanisms which underpin the response to this intervention.~   "
29038|NCT03186911|"~     Participants will complete a phone screen and then one laboratory session. After completing~     in-person screening assessments, eligible participants will complete additional~     questionnaires. Participants will then choose an e-liquid flavor to use for the rest of the~     session. Participants will then sample two e-liquids that vary in nicotine content from~     little or no nicotine to a moderate level of nicotine, and questionnaires evaluating the~     subjective effects of each one. Participants will then complete a preference assessment where~     they choose between the two e-liquids. Participants will be blind to the nicotine contents.~   "
29039|NCT03186898|"~     This phase III trial studies how well radiation therapy with protons works compared with~     photons in treating patients with liver cancer. Radiation therapy, such as photon therapy,~     uses high energy x-rays to send the radiation inside the body to the tumor while proton~     therapy uses a beam of proton particles. Proton therapy can stop shortly after penetrating~     through the tumor and may cause less damage to the surrounding healthy organs and result in~     better survival in patients with liver cancer.~   "
29040|NCT03186885|"~     Much has been learned about the efficacy and effectiveness of comprehensive healthy lifestyle~     interventions to reduce obesity. Few studies have been translated into rural settings or~     among Latinos. Y Living is an evidence-based family-focused intervention (FI) designed for~     urban Latino families. The FI is a 12-week behavioral modification program grounded in social~     cognitive theory, designed to engage the whole family in lifestyle changes by developing~     knowledge and skills in physical activity and healthy eating, building skills in goal-setting~     and self-monitoring, and creating a supportive home environment. Researchers will engage~     community partners in formative research to adapt the current FI for rural Latino families.~     Two parallel delivery methods of the FI will be developed and tested: 1) in-person group~     setting at a community center (FI-IP) and 2) home-based delivered remotely with technology~     (FI-RT). Both will be designed to address the unique social, cultural and environmental~     factors facing rural Latino families. The FI-RT will take advantage of innovative modern~     technology and e-Learning to increase program availability, accessibility and participation~     in rural settings. Researchers will conduct a 3-arm randomized controlled trial (RCT) to~     compare effectiveness of the two delivery approaches on weight loss (primary outcome) and~     energy balance behaviors (secondary outcomes) among obese Latino parent-child pairs versus~     control. The researchers will recruit 270 obese Latino adults (ages 21-65) with a child (ages~     8-17) from three primary care practices in rural South Texas. These parent-child pairs will~     be randomized to one of three arms stratified by clinic: 1) FI-IP (n=90); 2) FI-RT (n=90); or~     3) control group (n=90). Primary specific aims are to: 1) Conduct community-engaged formative~     studies to transform the existing FI into two unique delivery methods (FI-IP and FI-RT) for~     use in a subsequent RCT in a rural Latino community; and 2) Conduct a RCT to evaluate the~     comparative effectiveness of FI-IP and FI-RT to address weight loss (primary outcome) and~     energy balance behaviors (secondary outcomes) among obese rural Latino adults compared with~     adult participants in control group at immediate post intervention (3 months), after a~     3-month maintenance program (6 months post randomization) and a 6-month follow-up (12 months~     post randomization). A secondary aim is to examine the impact of FI-IP and FI-RT children's~     weight and energy balance behaviors.~   "
29041|NCT03186872|"~     Anxiety disorders and depression are more prevalent in patients living with inflammatory~     bowel disease (IBD) than in healthy controls. Approximately 40% of IBD patients have elevated~     anxiety. Given the robust effectiveness of cognitive behavioral approaches for anxiety~     disorders and the paucity or mixed findings of cognitive behavioral approaches for anxiety in~     IBD, an integrated behavioral approach and combining face to face and online cognitive~     behavioral modalities is recommended for IBD patients with anxiety.~   "
29095|NCT03186170|"~     The investigators propose to assess one method of sperm selection based on the~     characteristics of spermatozoa recently introduced: Sperm Selection Assay, which used a~     gradient of concentration of progesterone to act as chemoatractant of spermatozoa of better~     quality. We will assess in vitro fertilization with two techniques (SSSA versus traditional~     technique of swin up) as well as embryo development.~   "
29133|NCT03185663|"~     The fracture of the proximal femur is a common traumatic pathology in patients aged over 70~     years, associated with a mortality of 20 to 30% a year. The care is delayed emergency. During~     this wait, the occurrence of heel pressure ulcers is regularly found, despite wearing~     antiescarres slippers. Mobilization, source of pain, is also problematic.~      759/5000~   "
29042|NCT03186859|"~     Approximately 90% of people undergoing bariatric surgery have NAFLD, which is a condition~     where fat accumulates in the liver and can lead to inflammation and scarring. It mostly~     causes no symptoms, however, in the most advanced cases there is an increased risk of liver~     cancer or liver failure.~      NAFLD is currently managed by weight loss and treating associated diseases such as diabetes.~     No medicines have been licensed to directly treat it but bariatric surgery has been shown to~     be usually beneficial, although it is unknown whether some operations are better than others.~     It is also unclear whether this is due to general weight loss or other factors.~      This study will be conducted in a hospital setting and aims to determine what changes in~     liver fat and fat processing occur after pre-operative low calorie diet and the two most~     common types of bariatric surgery (Roux-en-Y Gastric Bypass and Sleeve Gastrectomy.~      Participants will have ten study visits, four of which may be combined with NHS appointments.~     Participants will undergo investigations including MRI scans to measure changes in NAFLD and~     DEXA scans to measure changes in fat and fat-free mass (FFM). Participants will also undergo~     mixed meal testing to which stable isotopes (deuterated water and 13c-palmitate) will be~     added to allow changes in fat processing to be detected. In addition to samples taken as part~     of NHS care, blood, urine, liver and fat (visceral and subcutaneous (abdominal and gluteal))~     will be used for research. Visits will take place before and after low calorie diet and~     bariatric surgery.~   "
29043|NCT03186846|"~     In the last 25 years, there has been a lot of attention directed on reducing perioperative~     morbidity and mortality by improving intraoperative monitoring and hemodynamic optimisation~     of patients. Advanced monitoring devices and new parameters have shifted the focus of~     anaesthesia management from macro- to micro circulation with the emphasis on the determinants~     of oxygen delivery and tissue oxygenation. There is increasing evidence that long-term~     outcome is improved by goal-directed optimisation of hemodynamic parameters (optimisation of~     stroke volume and cardiac output by fluids and inotropic and vasoactive drugs). Besides, new~     monitoring possibilities (depth of anaesthesia and cerebral and tissue oxygenation monitors)~     and adherence to protocols have proved beneficial in reducing morbidity cognitive~     dysfunction.~      However, questions are raised what the optimal goals (healthy population derived normal~     values, preoperative values, maximal values, restrictive fluid management) should be.~     Secondly, all new methods were used separately and there is a lack of studies to show the~     effect of combined (multimodal) monitoring on occurrence of cognitive dysfunction. All~     gathered data indicate that the combined use of new methods with adherence to an appropriate~     protocol might radically improve the perioperative management and outcome of high-risk~     surgical patients.~      The present study tests the hypothesis that intraoperative multimodal monitoring with~     hemodynamic optimisation, BIS-guided anaesthesia and maintenance of optimal cerebral oxygen~     saturation will reduce cognitive dysfunction.~   "
29044|NCT03186833|"~     The study addresses the hypothesis that a gradual build-up in arterial resistance and~     microvascular endothelial dysfunction due to common comorbidities such as hypertension and~     diabetes mellitus, on top of age related vascular and cardiac changes (mainly fibrosis and~     hypertrophy), is responsible for HFpEF. The HFpEF syndrome is commonly seen in elderly~     subjects (often females) with hypertension and diabetes.~      The investigators will investigate the vascular function, cardiovascular performance and~     myocardial fibrosis in different cohorts of subjects to try and prove this hypothesis. There~     will be 5 groups of subjects, all ≥ 70 years of age, as follows:~      A) Normal healthy volunteers without major comorbidities including hypertension or diabetes~     B) Patients with hypertension only (without diabetes mellitus) C) Patients with hypertension~     AND diabetes mellitus D) Patients with HFpEF. E) A parallel group of patients with Heart~     Failure with reduced Ejection Fraction (HFrEF) group.~      Arterial resistance measured by pulse wave velocity will be the primary measure and will be~     compared between groups A to D. A separate comparison will be made between groups D and E.~     Other secondary measures will focus on endothelial function (Laser Doppler measurements) and~     other cardiovascular performance measures (peak VO2 by CPEX, 6-minute walk distance). Bloods~     samples will be taken for NT-proBNP, high sensitivity Troponin T, Galectin 3 and also stored~     for testing later for vascular biomarkers.~   "
29045|NCT03186820|"~     Knowledge of the precise location of endometriosis is essential for a successful surgical~     treatment. MRI Susceptibility-Weighted Imaging (SWI-MRI) yields high sensitivity for blood~     by-products detection. Since endometriosis lesions are haemorrhagic, and therefore rich in~     blood by-products such as hemosiderin, SWI-MRI could be useful in the pre-operative~     assessment of endometriosis, especially in superficial peritoneal lesion detection. The~     purpose of our study is to evaluate the performance of SWI-MRI for the preoperative work-up~     of endometriosis~   "
29046|NCT03186807|"~     The aim of this study is to evaluate the normal development of cerebral cortex with~     quantitative measurement in low risk pregnant women~   "
29047|NCT03186794|"~     Background:~      As many as 1.5 million Americans are living with systemic lupus erythematosus (Lupus). Lupus~     makes people very tired. It also makes it hard for people to be physically active. Studies~     have shown that aerobic exercise training helps people with heart or lung illnesses be less~     tired and more active. Researchers want to use an exercise training program on people with~     Lupus to see if it has the same results.~      Objectives:~      To find out if aerobic exercise helps people with Lupus be less tired and more active.~      Eligibility:~      Women ages 21-80 who have Lupus and are not physically active.~      Design:~      Participants will be screened with a medical history and physical exam. They will have heart~     and lung tests, as well as blood and urine tests. They will also answer questions about their~     quality of life and take a test that measures lupus activity.~      The study will last 14-16 weeks.~      For the first two study visits, participants will do treadmill exercise tests and answer more~     quality of life questions. For these treadmill tests, participants will wear sensors, a mask,~     or a mouthpiece while they exercise.~      Participants will then begin exercise training, 3 times a week for 12 weeks. At each of these~     visits, they will walk very fast for 30 minutes on a track or a treadmill. Each visit will~     last about 1 hour.~      At the halfway point of the study, participants will repeat some of the screening tests. This~     visit will last about 3 hours.~      At the end of the study, participants will repeat the screening tests. They will also repeat~     the treadmill exercise tests.~   "
30669|NCT03165604|"~     In the present study the investigators will examine the impact of varying information~     (positive compared to standard information) concerning a drink for improving physical fitness~     in overweight children.~   "
29048|NCT03186781|"~     Background:~      Influenza is a very common infectious disease. Influenza is also called flu. Vaccines teach~     the body to prevent or fight an infection. When the body learns to fight an infection, this~     is called an immune response. Researchers want to develop a vaccine against flu. They want to~     test two new vaccines to help the body make an immune response to flu.~      Participants will get the vaccines (shots) in the upper arm muscle. One vaccine, the~     Influenza HA Ferritin vaccine, will be given to all participants with needle injection. The~     other vaccine, Influenza DNA vaccine, will be given to participants in Group 3 by a~     needle-free device that uses high pressure to push the vaccine through the skin and into the~     muscle.~      Objective:~      To test the safety and side effects of two new vaccines for prevention of H2 influenza (flu).~      Eligibility:~      Part I: Healthy adults at least 18 years old and born after 1969.~      Part II: Healthy adults ages 18-70, but not born in 1966-1969.~      Design:~      Volunteer participants will be tested for eligibility in a screening study.~      In Part I, all participants will get shots of HA Ferritin vaccine. Five participants in Group~     1 will get one shot of low dose vaccine at Day 0 to test if it is safe and has no serious~     side effects. Then, five additional participants in Group 2 will get two shots of a higher~     dose at Day 0 and 4 months later.~      Part II will study responses of adults born before 1966 and those born after 1969. Also, Part~     II will compare responses to 2 different vaccine plans. Group 3 will get a DNA Influenza~     vaccine at Day 0 and the HA Ferritin vaccine 4 months later. Group 4 will get HA Ferritin~     vaccine at Day 0 and 4 months later.~      Participants will record their temperature and look at the injection site(s) each day for 7~     days after each injection- they will write any symptoms at home on a paper diary or enter~     this data online.~      Participants may choose to have leukapheresis. This is a procedure where the blood will be~     removed through a needle in an arm. A machine will separate some of the white blood cells~     from the blood. The rest of the blood will be returned through a needle into the other arm.~     The leukapheresis procedure lasts 3-4 hours.~      There will be about 9 to 10 clinic visits over 10 months. At each visit, participants will be~     asked about health changes or problems. They will have a short physical exam. Blood will be~     taken. Participants might have extra visits and blood tests if they have changes in their~     health. Vaccination visits will last approximately 4-6 hours; other visits will last~     approximately 1 hour.~   "
29049|NCT03186768|"~     The soap on a rope behavioral trial is a school-randomized trial to determine if a disruptive~     cue (the soap on a rope hall pass) can influence hand washing behavior for students in~     Namwala District, Zambia.~   "
29050|NCT03186755|"~     This study compares the efficacy of Hylo-Dual (Hyaluronic acid 0.05% & Ectoine 2.0%) and~     Olopatadine (Olopatadine hydrochloride ophthalmic solution 0.1%) in the control of seasonal~     allergic conjunctivitis in the pediatric population. Half of participants will receive~     Hylo-Dual, while the other half will receive Olopatadine treatment for 2 months.~   "
29051|NCT03186742|"~     Obstructive sleep apnea syndrome (OSA) is the most frequent sleep disorder characterized by~     excessive decrease in muscle tone of the soft palate, the tongue and the posterior pharyngeal~     wall. It leads to airway collapse. In cases of decreased airway passage hypoventilation~     (hypopnea) occurs while periodic lack of airflow is called apnea. An obstructive sleep apnea~     syndrome is recognized as an independent cardiovascular risk factor. OSA is very common in~     patients with resistant hypertension. RAH is diagnosed when blood pressure remains elevated~     despite simultaneous use of 3 antihypertensive agents from different groups of drugs at~     optimal to maximum doses, including a diuretic.~      In patients with OSA frequent episodes of hypoxemia during sleep result in the repeated~     activation of the sympathetic nervous system. What is more, the episodes of respiratory~     disorders increases in levels of aldosterone serum concentration with following sodium and~     water retention and elevation of blood pressure finally. An increased aldosterone level also~     stimulates synthesis of collagen, promotes stiffening of the arterial wall, myocardial~     fibrosis with heart muscle remodeling and takes part in development of left ventricular~     hypertrophy (LVH) - common complication of hypertensive patients with OSA. Several studies,~     including the Sleep Heart Health Study have confirmed that severe OSA is associated with high~     prevalence of concentric hypertrophy through sympathetic activation and vasoconstriction.~      Eplerenone is a selective mineralocorticoid receptor inhibitor. It has no affinity for~     glucocorticoid, progesterone and androgen receptors and therefore has lower risk of side~     effects. Eplerenone lowers blood pressure and inhibits heart muscle fibrosis. The hypotensive~     effect is caused by reduction of fluid retention. Probably, in patients with OSA, a reduction~     of fluid accumulation especially at the level of the neck may contribute to lowering the~     resistance in the upper respiratory tract and in that way it may help to decrease the~     severity of OSA.~      As LVH remains a strong and independent predictor of total mortality and death from~     cardiovascular causes, in this study we want to assess whether the addition of Eplerenone to~     a standard antihypertensive therapy will favorably change left ventricular geometry. We also~     want to check if the addition the Eplerenone to a standard antihypertensive therapy could be~     an effective therapeutic option for patients with OSA and RAH.~   "
29052|NCT03186729|"~     The study evaluates the effects of antithrombotic drugs (anticoagulant drugs or antiplatelet~     drugs) for prevention of ischaemic events in patients with intracerebral haemorrhage.~   "
29053|NCT03186716|"~     The effects of colostrum on intestinal permeability in critical ill patients has not been~     investigated. In current trial, intensive care unit patients with enteral feeding will~     receive either enteral colostrum or maltodextrin as placebo.~   "
29054|NCT03186703|"~     The goal of the McMaster Optimal Aging Portal is to be a trustworthy source for health~     information. The Portal team can see (through measuring analytics of website use) that~     thousands of people are using the Portal and the knowledge-sharing strategies in place (email~     alerts, Twitter and Facebook), with many more users added each month. Previous studies have~     measured the quality and trustworthiness of health information available online; others have~     studied the numbers and populations who use different types of information and how easy it is~     to use and understand. This study builds on that knowledge to find out: if easy-to-understand~     evidence-based messages reach members of the public, do these messages change what people~     know and think to do to stay healthy (in this case, what they know and think to do to lower~     their risk of cancer)?~   "
29055|NCT03186690|"~     This study aimed to evaluate the clinical performance of White MTA (MTA, Angelus, Londrina,~     Brazil) and Biodentine™ in pulp capping of cariously exposed mature permanent teeth.~      The investigator performed a prospective longitudinal randomized controlled study utilizing~     vital permanent mature teeth with deep caries. Patients will be divided randomly into~     Biodentine™ and MTA groups; Teeth will be assessed clinically and radiographically prior to~     the procedure. Caries will be excavated under local anesthesia, hemostasis is achieved after~     pulp exposure using NaOCl and will be capped with Biodentine™ or MTA. Clinical and~     radiographical follow-up will be performed by a blinded calibrated evaluator after six months~     and one year, and yearly after.~   "
29056|NCT03186677|"~     This study is a phase 1, open-label, multi-center, dose-escalation study to investigate the~     safety, pharmacokinetics and pharmacodynamics of ISU304/CB2679d in previously treated~     hemophilia B patients.~   "
29096|NCT03186157|"~     Decompressive craniectomy is frequently used to treat increased intracranial pressure or an~     intracranial mass effect. Trephined Syndrome describes a neurological deterioration, which is~     attributed to a large craniectomy. The symptomatology is varied but includes headache,~     aggravation of a hemisyndrome or cognitive disorders, often has an orthostatic component and~     improves or disappears with cranioplasty. The incidence of Trephined Syndrome has been~     reported between 7% and 26%. However, it might be underestimated if the course of cognitive~     functions before and after cranioplasty were insufficiently documented.~   "
29097|NCT03186144|"~     1. Clinical description of a French cohort of patients with CHARGE syndrome.~        2. Search any phenotype-genotype correlation in typical, atypical or incomplete form of the~          syndrome~        3. Using Next generation Sequencing, try to identify other genes involved in this syndrome,~          as the CHD7 gene is involved in only 40-60% of cases~   "
29098|NCT03186131|"~     There has been no comparative data between oral ibandronate and oral ibandronate plus active~     vitamin D~   "
29057|NCT03186664|"~     Spasticity is frequently experienced by people with Multiple Sclerosis (MS), negatively~     impacting on patient's motor functional outcome, including walking. Currently, none of the~     available MS disease-modifying medications has been shown to stop or reverse gait disability.~     Recently the nabiximols has been tested for the treatment of spasticity and walking~     impairment in MS. Nabiximols (trade name Sativex®) is an oromucosal spray formulation~     containing 1:1 fixed ratio of delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD)~     derived from cloned Cannabis sativa L. plant. The main active substance, THC, acts as a~     partial agonist at human cannabinoid receptors (CB1 and CB2), and may modulate the effects of~     excitatory (glutamate-GLU-) and inhibitory (gamma-aminobutyric acid -GABA-)~     neurotransmitters, leading to muscle relaxation, which in turn is responsible for spasticity~     improvement. Cannabinoid receptors may modulate both excitatory and inhibitory transmission~     at central synapses, and have been heavily implicated, in animal models, in multiple forms of~     synaptic plasticity, such as long-term potentiation (LTP) and long-term depression (LTD).~     Indeed, in a previous study implying transcranial magnetic stimulation (TMS) technique, it~     has been hypothesized that the activation of cannabinoid receptors by Sativex® could modulate~     the balance between LTP and LTD like plasticity by changing the state of cortical~     excitability. In a recently study it has been proposed that Sativex may modulate the cortical~     excitability changing the activity of inhibitory GABAergic cortico-cortical synapses. Aim of~     our study is to clarify the role of Sativex coupled to a robotic neurehabilitation training~     in MS patients in improving the motor outcome, by means of clinical, kinematic, beside some~     neurophysiological and measures.~   "
29058|NCT03186651|"~     This is a prospective, randomized, controlled, two-armed multi-center pre-market trial.~     Nighty-six (96) subjects will be recruited at sites in Sweden. Patients with diagnosed stress~     urinary incontinence (SUI), will be considered as potential study participants. After written~     informed consent has been acquired, a medical and surgical history, a physical examination~     (including pelvic examination), and a confirmation of the diagnosis of SUI will be performed,~     followed by a confirmation of the inclusion/exclusion criteria. The study subjects fulfilling~     all the eligibility criteria will thereafter be randomized 3:1 into either the TVS group or~     the standard of care (SoC) group.~   "
29059|NCT03186638|"~     This randomized phase II trial studies how well exercise and low-dose ibuprofen in improving~     cognitive impairment in patients with colorectal cancer that has not spread to other places~     in the body who are receiving chemotherapy. Anti-inflammatory agents, such as ibuprofen, may~     slow the decline of cognitive processes and diseases involving the brain. Exercise may also~     help alleviating cognitive difficulties during chemotherapy.~   "
29060|NCT03186625|"~     Recent studies highlight the participation of gut microbes in the pathogenesis of both~     atherosclerotic heart disease and its adverse thrombotic events. Trimethylamine N-oxide~     (TMAO) is a plasma metabolite shown to be formed through a metaorganismal pathway involving~     nutrient precursors abundant in a Western diet and the sequential action of gut microbiota.~     Numerous studies reveal an association between systemic TMAO levels and cardiovascular risks~     in a variety of stable cohorts. The purpose of this study is to evaluate the efficacy of~     traditional Chinese Medicine formular (Compound pseudo-ginseng granules ) on the level of~     TMAO for the patient with acute coronary syndrome(ACS) undergoing percutaneous coronary~     intervention. 80 patients with ACS would be randomly allocated into interventional group(IG)~     and control group(CG). The patients in the IG would be administered by oral Compound~     pseudo-ginseng granules (twice per day ) for 90 days and those in the CG would receive the~     placebo twice per day during the same period. All of subjects would be administered with~     standard therapy in accordance with AHA/ACC guideline for ST-elevation myocardial~     infarction(STEMI) and Non ST-elevation myocardial infarction(NSTEMI).The primary endpoint is~     the plasma level of TMAO at 90-day follow-up. The second endpoint is the level of lipid,~     score of The Seattle Angina, fecal DNA extraction and pyrosequencing.~   "
29061|NCT03186612|"~     Introduction. Multiple sclerosis (MS) is the most common neurological disease causing~     disability in young adults. Neurorehabilitation is a fundamental aspect in the treatment~     approach for MS, in which new technologies have gained popularity, especially the use of~     virtual reality (VR), thanks to the therapeutic possibilities offered for patients with MS~     presenting cognitive, sensitive and motor dysfunctions.~      Aim. To analyze and compare an occupational therapy intervention (OT) compared with OT + VR~     (OT+VR) on the manual dexterity of patients with MS.~      Material and methods. 26 patients will be recruited. The control group (n=8) will recieve 20~     conventional OT sessions distributed in two sessions per week. The experimental group OT+VR~     (n=8) will recieve 20 sessions of VR interventions, twice weekly and lasting 30 minutes,~     consisting of VR games accessed via the online webpage motiongamingconsole.com, including~     Flip Out, Air Hockey, Partículas, Dunkit, Cuenta peces and Robo Maro, in addition to the~     conventional OT sessions. Pre and post-intervention assessments will be based on the Purdue~     Pegboard Test, the Jebsen Taylor Hand Function Test and the Grooved Pegboard Test.~   "
29062|NCT03186599|"~     A trial will be conducted on 200 breast cancer patients with adjuvant hormonal therapy. The~     study included 6 months baseline measurement, and 12 months intervention. Patients will be~     assigned to high adherence or low adherence group. Then, through randomization, low adherence~     patients will be assigned to the intervention or control group. Study Coordinator delivers~     the intervention using the WALKON mobile application. Control participants receive usual care~     with continuous monitoring using Medication Event Monitoring System (MEMS) device.~   "
29099|NCT03186118|"~     This study will enroll patients who have been enrolled into study PLAT-02 and meet the entry~     criteria for study PLAT-03.~      Patients with relapsed or refractory CD 19+ leukemia who have achieved remission after CD19~     CAR-T cell treatment sometimes relapse because the CD 19 CAR-T cells decrease in number over~     time. Study PLAT-03 will test whether administering T cell antigen presenting cells (T-APCs)~     at intervals following treatment with CAR-T cells improves CD 19 CAR-T cell persistence and~     reduces the incidence of leukemia relapse.~   "
29100|NCT03186105|"~     The investigators will conduct a monocentric prospective preliminary study evaluating the~     feasibility of appendectomy for simple acute appendicitis in a cohort of 6-17 year-old~     children presenting to the emergency department of the Hôpital Pédiatrique de Nice CHU-Lenval~     (Lenval Childre Hospital, Nice) on a Period of 1 year.~   "
29063|NCT03186586|"~     Objectives: To assess if the administration of ulipristal acetate (UPA) in users of the~     levonorgestrel-releasing intrauterine system (LNG-IUS) with breakdown bleeding or abnormal~     bleeding, could be able to inhibit the bleeding and if this effect will be sustainable up to~     three months after treatment.~      Material and methods: A total of 32 women aged between 18-45 years, users of the LNG-IUS with~     breakdown bleeding, abnormal bleeding or prolonged bleeding (bleeding more than 14 days) or~     episodes of bleeding with intervals less than 24 days). The study is an experimental, double~     blind randomized (16 women will receive UPA 5 mg/day/5 days; 16 women will receive placebo/1~     time/day/5 day). The women will invited to participated at the Family Planning clinic at the~     day they consulted with the complaint of bleeding. That day they will allocated at random to~     UPA or placebo group. They will oriented to fill out a bleeding calendar through 90 days~     after the pill intake. In addition a ultrasonography scan will be perform before the first~     day of pill intake and at 90 days after.~      Statistical analysis: A a pilot study the sample was estimated in 26 women (13 at each group)~     based at the estimative of success of 0.95 with UPA and 0.35 with placebo with significance~     of 0.05 and power of 80%. The sociodemographic characteristics will be analyzed as mean and~     SD and will compared through Mann-Whitney, Yates χ2 and Fisher exact tests as apropriate.~     Also, a regression analysis (Poisson analysis) with the dependent significant variables. The~     established level of significance will be p < 0.05.~   "
29064|NCT03186573|"~     This project aims to evaluate if after 14 days of grape juice ingestion there is improvement~     of the parameters of strength, fatigue and oxidative stress in judo fighters. The study will~     be a randomized, blind, crossover clinical trial of 20 Judo athletes. Judo wrestling~     simulations will be performed on 3 different days.~   "
29065|NCT03186560|"~     This is a single centre open label study measuring microcirculatory flux using Speckle~     imaging Device.~      Microcirculation will be measured using laser speckle contrast imaging, at baseline and with~     the device active for 30 minutes in the wound, peri-wound and other point on the lower leg.~     The same procedure will be done on all the different patient groups.~      Temperature variations can be assessed using Infrared Temperature Scanner (Exergen DermaTemp~     DT1001), a measurement will be taken at baseline, and then at 5 minutes interval during the~     30 minutes activity of the device.~   "
29066|NCT03186547|"~     The aim of the proposal study is to answer the question of how to manage gummy smiles due to~     hypermobile upper lip with less invasive and low risk level procedure . This trial will help~     the practitioners and the patients in taking the convenient decision to correct the gumminess~     to restore lip-gingival-dental harmony and enhance smile asthetics.~   "
29067|NCT03186534|"~     Young gay, bisexual, and other men who have sex with men (YMSM) are the only risk group in~     which rates of new HIV infections are on the rise. There has been a relative dearth of~     research dedicated to understanding these health disparities between gay/bisexual and~     heterosexual youth, and even less has focused on identifying factors that might promote~     resilience against negative health outcomes. Understanding both risk factors and processes of~     resilience is critical in developing efficacious interventions to improve health in this~     population.~      Through a grant from the National Institutes of Health, the investigators completed formative~     research with young male couples. Qualitative interviews identified preferences for~     couples-based intervention format and content. While coupled YMSM expressed some interest in~     HIV prevention, participants were most interested in building relationship skills. Coupled~     YMSM preferred group-based interventions in order to meet and learn from other couples but~     had concerns about discussing personal topics in groups. Quantitative analyses found that the~     rate of condomless sex in couples increased from adolescence to young adulthood. Further, the~     influence of older partners, partner violence, and drinking before sex were strongest in~     emerging adulthood. Informed by these, the research team developed 2GETHER, which aims to~     reduce HIV transmission risk in couples by enhancing relationship functioning. 2GETHER is a~     four session program. The first two sessions are group sessions aimed at skills building, and~     the second two sessions are individualized couple sessions aimed at skills implementation.~     Modules address communication skills, coping with stress (both general and sexual~     minority-specific stress), relationship sexual satisfaction, and HIV transmission risk within~     the dyad and with outside partners. 2GETHER was designed to address HIV transmission risk in~     couples regardless of HIV status; couples learn to use behavioral and biomedical approaches~     to prevent both HIV acquisition (e.g., HIV testing, condom use, pre-exposure prophylaxis) and~     transmission (e.g., medication adherence to reduce viral load), with an overarching emphasis~     on the health of the couple.~      The investigators completed a pilot trial of 2GETHER with funding from Northwestern~     University. The pilot trial enrolled 57 couples (N=114) and demonstrated feasibility,~     acceptability, and preliminary efficacy of 2GETHER. This pilot trial used a non-randomized~     pre-/post-test design because the goal was to evaluate feasibility, acceptability and~     preliminary effects in a large number of diverse couples to inform a future efficacy RCT.~     Post-test occurred 2 weeks post-intervention, or ~2 months post-baseline. The pilot trial~     recruited a diverse sample of couples in less than one year and each program module receive~     high ratings of acceptability during post-sessions evaluation and an exit interview. At the~     2-week post-test, the investigators observed significant decreases in HIV risk behavior,~     improvements in motivation to reduce HIV risk, and improvements in relationship investment.~      The current study will conduct a randomized controlled trial (RCT) to test the efficacy of~     2GETHER, a novel couples-based intervention for young men who have sex with men (YMSM) that~     aims to reduce HIV transmission risk by optimizing relationship functioning. The~     investigators will conduct an RCT with 200 dyads (total individual N=400), who will be~     randomized to receive the 2GETHER intervention or an attention-matched couples-based positive~     affect promotion program.~   "
29068|NCT03186521|"~     To show that the nurse implementation of a sedation and analgesia algorithm is beneficial to~     the patient in terms of sedative drugs reduction and thus overall decrease in duration of~     mechanical ventilation and the morbidity and mortality which is associated with it, without~     altering patient comfort and tolerance of the environment. This, compared to the less~     frequent assessments by doctors and thus regular adjustments during the day as opposed to a~     fixed drug dose.~   "
29069|NCT03186508|"~     Enhancing children's sleep may be a novel approach for prevention of obesity and~     cardiovascular (CV) disturbance. Observational studies with children demonstrate that short~     sleep increases risk of obesity and other CV risk factors. Randomized controlled trials with~     children 8-11 years old demonstrate that enhancing sleep duration leads to positive changes~     in eating and activity behaviors and weight status, particularly for children who enhance~     their sleep the most. Enhancing sleep may be particularly important for racial minority~     children and those from lower socioeconomic backgrounds given their increased risk for short~     sleep, obesity and CV risk factors. In this study two active obesity preventive interventions~     will be evaluated: a) enhancing sleep alone (Optimize Sleep [OS]), and b) enhancing sleep~     along with eating and activity behaviors that have demonstrated efficacy for obesity~     prevention and are implicated in self-regulatory pathways related to sleep (i.e., energy~     dense snack foods and beverages, TV viewing, and physical activity) (OS-Plus). Two hundred~     four children 8-11 years old who are African American/black, primarily from low socioeconomic~     backgrounds, and who sleep < 9.5 hours/night into a 12-month study will be enrolled. Children~     will be randomly assigned to either OS or OS-Plus. Over the 6-month treatment phase, all~     children will attend an 8-session treatment; monthly phone contacts will occur during~     maintenance (6-12 months). Primary aim is to determine the efficacy of OS-Plus relative to OS~     on change in body mass index z-score (BMIz) at end of treatment. Secondary aims will assess~     efficacy of OS-Plus relative to OS on additional cardiometabolic risk factors, eating and~     activity behaviors. Exploratory aims will assess maintenance of effects at 12 months.~   "
29070|NCT03186495|"~     The trial is conducted in Europe. The aim of the trial is to investigate the steady state~     exposure of somapacitan in subjects with various degrees of renal impairment (mild, moderate,~     severe renal impairment, requiring haemodialysis treatment) compared to subjects with normal~     renal function~   "
29071|NCT03186482|"~     The purpose of this study is to look at the levels of three HIV medications: Descovy®,~     Viread® and Rifadin® in the blood after drug intake has been stopped, in order to understand~     how long these drugs persist in the blood. The study will specifically look at blood levels~     of these three drugs after taking them every day for 28 days. Participants will take Descovy®~     on a first stage, a combination of Descovy® and Rifadin® on a second stage, and Viread® on a~     third stage. If the participants decide to take part, the duration of the study will be up to~     85 days plus a screening visit which will take place up to 28 days prior to the start of the~     study, and a follow up visit, which takes place 28 to 36 days after the last dose of study~     medication. This study is not randomised which means that all participants will receive all~     study medications in the same order. The participant and the study doctor will know which~     study medications the participant is taking at all times during the study.~      During the study, numerous blood samples will be taken which could cause inconvenience and~     distress for patients. Every effort will be made by study staff to minimise this. There are a~     lot of clinic visits during the study and three full days in the unit which may inconvenience~     patients. However, participants will be made aware of this both verbally and in the patient~     information sheet. Participants will also receive compensation for their time and travel~     expenses whilst participating in the trial. Participants or participants' partners who plan~     to become pregnant during the study will not be allowed to take part in the study. Further to~     this (if applicable), participants must use effective contraception for the duration of the~     study. Participants will have to adhere to other restrictions as detailed in the participant~     information sheet. These restrictions will be explained in full to all participants.~   "
29146|NCT03185494|"~     RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory~     into patient autologous or donor-derived T cells may make the body build immune response to~     kill cancer cells.~      PURPOSE: This clinical trial is studying genetically engineered lymphocyte therapy in~     treating patients with B-cell leukemia or lymphoma that is relapsed (after stem cell~     transplantation or intensive chemotherapy) or refractory to chemotherapy.~   "
29075|NCT03186430|"~     The primary research aim of this project is to test the effectiveness of a comprehensive,~     evidence-based vaccine promotion toolkit implemented in the pediatric healthcare setting on~     increasing the likelihood that adolescents in Georgia will initiate and complete the Human~     Papillomavirus (HPV) vaccine series. Secondary research aims include assessing the impact of~     the comprehensive toolkit on 1) patient and parent knowledge and attitudes regarding HPV~     vaccine, and 2) provider recommendation of HPV vaccine for males and females in the~     recommended age range (11-12 years). The intervention toolkit will include evidence-based~     components aimed at the practice-level, provider-level and parent-level that will be tested~     through a cluster-randomized trial design. The primary hypothesis is that implementation of~     the comprehensive vaccine promotion toolkit in the pediatric health care setting will~     increase the likelihood that an adolescent receives initiates HPV vaccination.~      At the initial visit, parents of adolescent patients at participating pediatric practices~     will complete a brief questionnaire assessing their knowledge, attitudes, and beliefs about~     adolescent health, including protection against infectious diseases during adolescence. The~     parents will be contacted again three months later to complete a short follow-up interview on~     the general health of their adolescent child, immunization status, and attitudes regarding~     vaccination.~   "
29076|NCT03186417|"~     This is a prospective, multicenter, double-blind, placebo controlled interventional study to~     evaluate the safety and efficacy of allogeneic mesenchymal stem cells (MSCs) in 20 patients~     with new onset Rheumatoid Arthritis (RA). The study is a single dose, phase I clinical trial~     and is the first time that this product will be infused in RA patients. The study duration is~     approximately fourteen months from time of screening to completion.~      Research hypothesis: The investigators hypothesize that when administered therapeutically,~     MSCs will induce healthy immune responses and will reduce RA disease activity. This study is~     primarily focused on demonstrating the safety of this approach.~   "
29077|NCT03186404|"~     Anthracycline (AC) chemotherapy has substantially reduced the mortality rate from several~     common cancers globally. Unfortunately, AC treatment is associated with up to 19% risk of~     heart failure (HF). Current standard of care for preventing AC induced HF (AIHF) is cardiac~     surveillance followed by initiation of treatment once HF is diagnosed. With this approach 89%~     of patients fail to recover heart function and 46% will experience adverse cardiac events.~     Therefore there is a need for effective preventive therapy to reduce the risk of AIHF. Based~     on small human studies, animal studies, and our own pilot data, statins are an ideal class of~     drug for this purpose.~      We will conduct a pilot double blinded, placebo controlled, randomized controlled trial to~     assess whether pre-treatment with statins before AC can prevent heart dysfunction. Eligible~     patients with cardiovascular risk factors scheduled to receive AC will be recruited. They~     will be randomized to statin therapy or placebo and followed until the end of cancer~     treatment. Primary outcome is the difference in cardiac MRI-determined left ventricular~     ejection fraction between pre-AC and end of treatment.~   "
29078|NCT03186391|"~     The aim of this study was to evaluate exercise testing in case of patients suspected of~     Peripheral Artery Disease (PAD).~   "
29079|NCT03186378|"~     The primary objective of the study is to determine the presence or absence of systemic~     cantharidin exposure from a single 24-hour dermal application of VP-102 topical film-forming~     solution [0.7% (w/v) cantharidin] (VP-102) when applied to molluscum contagiosum (molluscum)~     lesions on pediatric subjects 2 years old and older. Treatment will continue over the course~     of 3 additional 21 day intervals allowing for further evaluation of safety, efficacy and~     impact on quality of life.~   "
29080|NCT03186365|"~     Grazoprevir plus elbasvir 12 to 16 weeks is now approved for chronic hepatitis C (CHC)~     genotype 1, 4, or 6 infection regardless liver disease severity. The current study aims to~     explore the efficacy and safety of 8-week grazoprevir/elbasvir in HCV-1b patients with mild~     liver fibrosis~   "
29081|NCT03186352|"~     The problem of root caries has been increasing in last decades as the an average life~     expectancy is rising. Due to progress of medicine and dentistry humans also maintain natural~     dentition longer.~      The aim of the study is to determine the effectiveness of photoactivated disinfection /~     photodynamic therapy / photodynamic antimicrobial therapy in elimination of cariogenic~     bacteria after manual root caries removal.~      If proved to be effective in eliminating bacteria from prepared cavity PAD could be~     incorporated in the protocol of treatment of root cavities.~   "
29082|NCT03186339|"~     Prospective, multi-centre, multi-national registry with a follow-up of 3 months, in five~     European countries and Canada (Toronto), with elective patients undergoing TF-TAVI (n=120)~     and isolated SAVR (n=120), respectively and a control group of 50 patients receiving medical~     treatment only. All patient groups will fill in three different questionnaires to assess~     quality of life in 5 different languages (English, French, German, Italian and Spanish). One~     of these will be a new questionnaire, the Toronto Aortic Stenosis QoL (Quality of Life)~     questionnaire (TASQ).~   "
29083|NCT03186326|"~     Immune chekpoints (ICI) are evaluated in many digestive cancers. Certain types of cancer~     appear to be rather refractory to ICI such as colorectal cancers (CRC). However, the MSI CRC~     representing approximately 15% of the CRCs exhibits a high mutational load which generates~     many potentially immunogenic neoantigens. In addition, strong expression of PD-L1 was found~     in the MSI CRCs relative to the CRC (MSS) stages. Localized MSI CRCs have a better prognosis~     than MSS CRCs, probably due to immunogenic neoantigens associated with a CD8 + T-specific~     immune response. On the oher hand, in metastatic CRC (mCRC) things are different because i)~     the MSI frequency is only 4 to 7% and ii) the good prognosis conferred by the MSI status is~     controversial.~      Preliminary results suggest that patients with MSI mCRC are highly sensitive to ICI even~     chemoresistant tumors receiving several lines of chemotherapy. Recently, another anti-PD1~     alone or in combination with an anti-CTLA4 (antigen associated with cytotoxic T-lymphocyte 4)~     was tested in the MSI CRCs and a selection of interesting results in heavily pretreated~     patients with a disease control rate of 56% for monotherapy and 81% for combinated therapy.~      Anti-PD1s now have marketing authorization for patients with melanoma and metastatic~     pulmonary carcinoma , Which are known to have a high level of mutations . ICIs appear to be~     as promising in MSI CRCs as in other tumors and therefore face the same major challenges.~      Avalumab is an anti-PD-L1 antibody recently tested in several different types of tumors with~     promising results and is currently being studied in phase III in gastric cancer. There is no~     data on the effectiveness of this ICI in the MSI mCRCs. In addition, only anti-PD1 was used~     in the MSI-mCRC and not the anti-PD-L1, and only in chemoresistance (3rd line or more). The~     main objective of the SAMCO study is to test the efficacy and tolerance of avelumab in the~     2nd line of treatment in patients with a MSI mCRC progression after standard 1st line~     chemotherapy +/- targeted therapy.~   "
29084|NCT03186313|"~     A phase 3 Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of the combined~     single dose of Dactavira Plus (EPGCG, Sofosbuvir , Daclatasvir & Ribavirin) versus Sofosbuvir~     + Daclatasvir + Ribavirin (Part A) and a single dose of Dactavira (EPGCG, Sofosbuvir &~     Daclatasvir) versus Sofosbuvir + Daclatasvir (Part B) in Egyptian Adults with Chronic~     Genotype 4 HCV Infection.~   "
29085|NCT03186300|"~     Patient Empowerment through Predictive PERsonalised decision support (PEPPER) is an European~     Union (EU) funded research project to develop a personalised clinical decision support system~     for Type 1 Diabetes Mellitus (T1DM) self-management. The tool provides insulin bolus dose~     advice, tailored to the needs of individuals. The system uses Case-Based Reasoning (CBR), an~     artificial intelligence methodology that adapts to new situations according to past~     experience. The PEPPER system also incorporates a safety module that promotes safety by~     providing glucose alarms, low-glucose insulin suspension, carbohydrate recommendations and~     fault detection.The principal research objectives are to assess the usability, safety, and~     technical proof of concept and feasibility of the PEPPER in participants with T1DM.~     Evaluation of safety is a priority and will be assessed throughout the clinical studies. The~     safety components only of the PEPPER system will initially be evaluated in an out-of-clinic~     environment (phase 1) and will measure incidence and percentage time spent in hypoglycaemia,~     evaluate usability and incidence of technical faults. Following the initial safety study, the~     overall PEPPER system (integrated with the CBR algorithm) will be assessed (phase 2) and the~     primary outcome will be percentage time spent in hypoglycaemia.~   "
29086|NCT03186287|"~     The purpose of this study is to investigate and compare the effects of eccentric and~     concentric strength training on pain, strength, joint position sense and function in patients~     with subacromial impingement syndrome.~   "
29087|NCT03186274|"~     This study will evaluate how the educational intervention utilized affects pediatric resident~     comfort level with EOL discussions.~   "
29088|NCT03186261|"~     -  The teeth of the patients that meet inclusion criteria will be anesthetized, isolated~          with a rubber dam.~        -  Cavity opened using conventional high-speed rotary instruments.~        -  The central cariogenic biomass and the superficial parts of the necrotic dentine will be~          removed with round burs.~        -  Caries lesion will be completely removed in the enamel/dentin junction.~        -  The excavation procedure will be terminated as soon as the soft and wet dentine was~          removed and the remaining tissue was leathery but not hard on exploring.~        -  A dentinal sample will then be collected from the base of the cavity using sterile spoon~          excavator as a baseline for bacteriological assessment.~        -  Then, application of either intervention or control agent, another dentinal sample will~          be collected using a sterile excavator and transferred into sterile tubes and~          transferred to the laboratory for microbiological analysis.~        -  Filling of the cavity with resin composite restoration.~        -  All clinical procedures will be carried out at the same visit.~   "
29089|NCT03186248|"~     Aim of this study is to compare the outcomes of a short esophageal myotomy extending from 3~     cm cephalad to the EGJ, to 3 cm distal to it with a long esophageal myotomy with an~     additional proximal extension (at least 6 cm cephalad to the EGJ, to 3 cm distal) for POEM~     procedures. Principle of POEM is to reduce pressure gradient across LES by Myotomy.~     Hypothesis is that performing short myotomy will result in similar efficacy in achalasia~     cardia while reducing the total time taken for the procedure and ultimately will result in~     less complications.~   "
29090|NCT03186235|"~     Chronic hepatitis C infection is a global worldwide health problem with an increasing burden~     year-by-year, particularly in areas with a high endemicity like Egypt . The World Health~     Organization estimates that approximately 200 million people worldwide are infected with~     hepatitis c virus. In Egypt, it was estimated that 15 % of Egyptians have serologic evidence~     of hepatitis C viral infection .~   "
29091|NCT03186222|"~     Acne vulgaris is one of the most common skin diseases. It is a disease of the pilosebaceous~     units, clinically characterized by seborrhea, comedones, papules, pustules, nodules and, in~     some cases, scarring.~   "
29092|NCT03186209|"~     This is a randomised, double-blind, parallel group, placebo-controlled study designed to~     evaluate the efficacy and safety of a fixed 30 mg dose of benralizumab administered~     subcutaneously for patients with a history of asthma exacerbations and uncontrolled asthma~     receiving medium to high-dose inhaled corticosteroid plus long-acting β2-agonist (ICS-LABA)~     with or without oral corticosteroids and additional asthma controllers.~   "
29093|NCT03186196|"~     The C677T polymorphism of the MTHFR gene is associated to several biochemicals imbalances, as~     changes in folic acid serum levels and some inflammatory markers, elevating the oxidative~     stress and increasing the risk of developing non communicable diseases (NCDs).~      Thus, a diet containing folate as a main antioxidant nutrient, could reduce not only the~     oxidative stress, but also has many others benefits for individuals with this genetic~     alteration, like the anti-inflammatory function, which could help restore the altered serum~     levels and minimizing or avoiding the development of future diseases.~      The aim of this study was to evaluate the influence of the C677T polymorphism of the MTHFR~     gene and the effect of a diet containing folate in the inflammatory markers levels, such as~     homocysteine, Tumor Necrosis Factor alpha (TNF-α) and interleukins in women with overweight~     or obesity. This is an intervention study, double-blind, held in a city in northeastern~     Brazil, with a sample of 48 adult women (20-59 years old) with BMI among 26.19 kg / m² and~     49.64 kg / m². In which we evaluated the TNF-α levels, Interleukins 1β, Interleukin 6,~     Interleukin 8, Interleukin 12p70, Interleukin 10, homocysteine, folic acid and in addition to~     these markers evaluation, were made the genotyping for the C677T polymorphism in the MTHFR~     gene and the food consumption assessment by the 24 hour dietary recall (24HR). For the~     intervention, the sample was divided by randomization into two groups, each one with 24~     indivuals, receiving daily during 8 weeks, a salad with 300g vegetables containing 191 ug of~     folate for group 1 and 90 ug for group 2.~   "
29094|NCT03186183|"~     GPS is a sexual health promotion and HIV prevention peer-delivered counselling program. The~     GPS program has 4 parts: information provision about HIV and sexually transmitted infections,~     motivational interviewing counselling, sexual health behavioural skills building, and linkage~     to care. The adaptation grant has three goals: 1) to establish a multi-region and~     multi-sectoral team that can deliver the revised program across a variety of settings, 2) to~     learn how best to deliver this program as individual counselling program and also how to~     adapt this program for HIV-negative MSM, and 3) to pilot the individual program in 5 settings~     across Ontario and British Columbia. The research team will evaluate the pilot adaptation~     through mixed methods, employing a quantitative questionnaire and one-on-one semi-structured~     interviews.~   "
29147|NCT03185481|"~     The purpose of this study is to evaluate the long term safety and tolerability of PF-06649751~     in Parkinson's disease patients who experience motor-fluctuations.~   "
29101|NCT03186092|"~     Pulmonary hypertension (HP) is a progressive pathological condition presents with vascular~     changes in the lung. Cardiopulmonary changes in PH are considered the main limiting factor,~     however, it is known that the muscular alterations potentiate the symptomatology. Several HP~     factors and mechanisms have an impact on peripheral and respiratory muscle changes, so,~     specifically, respiratory muscles are also altered in patients with PH.~      In the face of respiratory muscle weakness, inspiratory muscle training (IMT) has been shown~     to increase respiratory muscle strength and functional capacity in chronic conditions such as~     obstructive pulmonary disease (COPD) and heart failure (HF).~      The objective of this study is to test whether a 12-week TMI protocol is capable of impacting~     functional capacity, respiratory muscle strength, spirometric values and quality of life in~     patients with PH.~   "
29102|NCT03186079|"~     Constipation is the most common complaint in childhood gastrointestinal disease,affecting an~     estimated 20% of the global children.The treatment strategies consist of diet~     control,behavioural intervention and oral and sometimes rectal laxatives. Given higher~     success rate and fewer side effects,the laxative PEG3350 has been considered the first choice~     in childhood constipation.However, effectiveness of PEG 3350 laxative is not lasting,~     additional treatment interventions are still necessary.With an unsatisfactory response to~     current treatments, many patients seek help from Chinese Herbal Medicine.In view of the~     traditional theory, childhood constipation is derived from weakness of gastric and splenic~     function.The functional weakness is characterized by food stagnation and further pathological~     heat accumulation in the gastrointestine. The food stagnation can slow the gastrointestinal~     motility while heat causes constipation by drying the intestines and their content.~     Therefore, the therapeutic principles and practices for childhood constipation must focus on~     the pathophysiological basis accordingly. In the documented traditional medicine~     dictionary(Pi Wei Lun), Xiaojidaozhi Decoction is well described in improving the gastric and~     splenic function, eliminating food stagnation and removing pathological heat accumulation,~     and it has always been used in treatment of constipation throughout Asia since the first~     description in Pi Wei Lun in 1249. It comprises twelve herbs. Through the combined action of~     these herbs, Xiaojidaozhi Decoction can increase fluid in the intestines and facilitate the~     gastrointestinal motility, relieving the symptoms of constipation. Despite of the long~     history of successful use of Xiaojidaozhi Decoction in childhood constipation, a large~     randomized placebo-controlled trial is still not available.The aim of this study was to~     explore the clinical efficacy and safety of Chinese herbal medicine Xiaojidaozhi Decoction in~     the treatment of childhood constipation.~   "
29103|NCT03186066|"~     Percutaneous endoscopic gastrostomy (PEG) is a method for nutrition delivery for patients~     with insufficient oral intake. A rare but severe complication of PEG is the Buried Bumper~     Syndrome (BBS). In BBS the internal fixation device of the PEG migrates along the stoma~     chanel. The internal fixation disc becomes covered by gastric mucosa, which causes loss of~     patency, fixation of the PEG and possible leakage around the PEG.~      BBS can be treated endoscopically by dissecting the overgrowing tissue with endoscopic~     submucosal dissection (ESD) knifes. A new and alternative approach is the use of the Flamingo~     device, which is inserted over the PEG and then is used to radially dissect the overgrowing~     tissue with a cutting wire.~      In this study both methods, the standard method using an ESD knife and the Flamingo device,~     are compared in a randomized controlled open-label trial. Primary endpoint is the time needed~     for PEG removal.~   "
29104|NCT03186053|"~     To explore the effect of intraoperative sodium creatine phosphate on myocardial protection in~     patients undergoing valve surgery~   "
29105|NCT03186040|"~     Lacosamide is administered for patients with amyotrophic lateral sclerosis (ALS).~   "
29106|NCT03186027|"~     The main aim of the study is to examine the effect of oral CoQ10 plus NADH (Reconnect®)~     supplementation twice daily for 8-weeks on the changes in fatigue perception, sleep~     disturbances, autonomic dysfunction and HRQoL assessed by patient-reported outcome measures~     in CFS/ME.~   "
29107|NCT03186014|"~     Dysphagia is the major symptom of patients with malignant esophageal stricture caused~     predominantly by advanced esophageal cancer. Stent placement is the most commonly used~     strategies for relieving the dysphagia and a novel irradiation stent loaded with 125I seeds~     has recently been developed. A multicentre randomized clinical trial demonstrated this~     irradiation stent can relieve the dysphagia rapidly and prolong the survival of patients with~     advanced esophageal cancer, but the total stent stenosis rate cannot be ruduced. A novel~     fully covered segmented retrievable irradiation stent was developed in our institute. The~     purpose of this study is to evaluate the safety and clinical efficacy of this newly developed~     irradiation stent in patients with unresectable malignant dysphagia.~   "
29108|NCT03186001|"~     The botulinum toxin was first identified in the late 19th century(1). With its 40 different~     subtype this toxin is produced mainly by the gram positive anaerobic bacteria Clostridium~     Botulinum(2). This neurotoxin has great affinity to the neuro muscular junction preventing~     neurotransmitter release in the synaptic space of acetylcholine(3). The first clinical use~     was reported by Alan Scott in 1980(4). The most commonly used subtype is toxin A commercially~     found as BOTOX (onabotulinumtoxinA, Allergan, approved by FDA in 1989), Dysport~     (abobotulinumtoxinA, Medicis, approved by FDA in 2009) and Xeomin (incobotulinumtoxinA, Merz,~     approved by FDA in 2010). As for other commercial toxins botulinum neurotoxin serotype B~     product (MYOBLOC™). Neurotoxin Blast generally 12-15 weeks compared to 3-6 month for~     neurotoxin A. the FDA approved its use for strabismus in 1989(5), blepharospasm and~     hemifacial spasm in 1990(6,7), cervical dystonia in 2000(8), glabella in 2000, hyperhidrosis~     in 2004(9), chronic migrane and detrusor overactiviy in 2014. Other off-label uses have~     emerged like lanyngeal dysponia, chronic pain etc… (10). Multiple studies with a reduced~     number of patients have aimed to quantify the effect of botulinum toxin on brow higth. Some~     studies used injections only to the lateral part of the orbicularis,while others added a~     corrugator injection. We aimed in this study to compare a known techniques in brow lifting~     and associanting that with 2 frontalis injection techniques. The main objective is to~     evaluate the shape of the brow and the elevation in multiple brow landmarks before and after~     the injection and to see if the frontalis botulinum bloc causes brow ptosis~   "
29109|NCT03185988|"~     To seek the efficacy signals of trastuzumab in combination with chemotherapy in pretreated~     patients of HER2 positive, relapse or metastatic carcinoma of digestive system as response~     rate (RR) determined by the Investigator using RECIST 1.1, and provide evidence for phase III~     clinical trial.~   "
29122|NCT03185806|"~     The acute peripancreatic fluid collections (AFPCs) is the most common complication in severe~     acute pancreatitis (SAP). There are controversies on optimal timing for drainage of APFCs in~     SAP. The early-stage percutaneous catheter drainage (PCD) of sterile peripancreatic fluid~     collections is questioned as a result of the major cause of secondary infection. The aim of~     the present randomized controlled trial is to compare the outcomes in terms of mortality,~     secondary infection of peripancreatic collections, organ failure, length of hospital/ICU stay~     and inflammatory biomarkers between the early-stage PCD of sterile AFPCs and conservative~     therapy.~   "
29110|NCT03185975|"~     This research study will recruit 200 transgender youths between the ages of 15-24. There are~     two arms to the research study: the control and the intervention arm. Each eligible~     participant will be randomized into either arm. The control arm participants receive an~     OraQuick HIV testing kit sent to an address of their choice and instructions of how to~     conduct the test. They will enter their results on the research study website and complete~     surveys at 3 month intervals until an entire year has passed. Participants in the~     intervention arm will receive an OraQuick HIV testing kit sent to them and will receive~     video-based counseling called Motivational Interviewing and Certified Testing and Referral.~     After this counseling session, the results from the OraQuick HIV test will be logged by study~     staff. Then, participants in the intervention arm will fill out surveys at 3 month intervals~     until a year has passed.~   "
29111|NCT03185962|"~     Extubation failure can directly worsen patient outcomes. Therefore, the decision to extubate~     is a critical moment during an intensive care unit (ICU) stay. The decision to extubate is~     usually made after a weaning readiness test involving spontaneous breathing on a T-piece or~     low levels of ventilatory assistance. However, extubation failure still occurs in 10 to 20%~     of patients. The investigators focused on previously reported physiological risk factors, and~     were able to obtain from common clinical practice: 1) age, 2) underlying cardiovascular~     disease, 3) underlying respiratory disease or occurrence of pneumonia, 4) rapid shallow~     breathing index (RSBI), 5) positive fluid balance during the previous 24 hours, 6) the ratio~     of arterial oxygen partial pressure to fractional inspired oxygen, 7) Glasgow Coma Scale, 8)~     respiratory tract secretions. The investigators aimed to assess the incidence and risk~     factors for extubation failure among critically ill patients who passed the 30 min~     spontaneous breathing test (SBT) using a low level of pressure support (PS) with positive~     end-expiratory pressure (PEEP), in a prospective multicenter study.~   "
29112|NCT03185936|"~     To evaluate the anatomical and functional results of pars plana vitrectomy (PPV) combined~     with internal limiting membrane (ILM) peeling, endolaser photocoagulation and gas tamponade~     in management of optic disc pit (ODP) maculopathy.~   "
29113|NCT03185923|"~     This study evaluates the integrated traditional Chinese and Western medicine in the treatment~     of severe community acquired pneumonia in adults. Half of participants will receive~     traditional Chinese and Western medicine in combination, while the other half will receive a~     placebo traditional Chinese and Western medicine.~   "
29114|NCT03185910|"~     The purpose of this study is to explore the differences between stress, depression,~     childbirth self-efficacy, mindfulness and postnatal maternal outcomes in pregnant women with~     Mindfulness-Based Childbirth and Parenting education program.~   "
29115|NCT03185897|"~     Assess the seroprevalence of neutralizing antibodies (NAb) to AAV in adults with severe~     hemophilia A (coagulation factor VIII [FVIII] <1%) or moderately severe to severe hemophilia~     B (coagulation factor IX [FIX] ≤2%).~   "
29116|NCT03185884|"~     This study will evaluate the impact of test carbohydrate blends on fat and carbohydrate~     oxidation, glucose, insulin and hunger scores in pre-adolescent boys and girls.~   "
29117|NCT03185871|"~     The overall purpose of this study is to assess whether celecoxib can reduce the change in~     collagen alignment and inflammatory response in the tumor tissue of primary breast cancer~     patients with invasive breast carcinoma after 2 weeks of oral intake.~   "
29118|NCT03185858|"~     Despite the significant burden of stroke in rural China, secondary prevention of stroke is~     scarce. The aim of the study is to develop a system-integrated technology-enabled~     intervention (SINEMA) model for the secondary prevention of stroke in rural China and~     evaluate the effectiveness of the model compared with usual care. The hypothesis is that~     trained village doctors, equipped with digital health technology, can provide essential~     evidence-based care to stroke survivors in rural China.~   "
29119|NCT03185845|"~     Anticoagulation is the most important treatment for pulmonary thromboembolism (PTE). The~     thromboembolism risk is especially high in patients with chronic obstructive pulmonary~     disease (COPD) exacerbations. However, there's no agreement on the most appropriate duration~     of anticoagulation in COPD with PTE to balance the risk of recurrence of thrombosis and~     bleeding. This randomized, controlled trial aims to evaluate the risk and benefit of~     prolonged anticoagulation compared with the regular 3-month anticoagulation in COPD with PTE.~   "
29120|NCT03185832|"~     The purpose of this observational registry is to collect clinical events and outcome data in~     4 different study populations (cohorts), with a majority of Japanese subjects, that are at~     risk of sudden cardiac death (SCD) and heart failure (HF) events. These event rates will be~     compared with available published data mainly from Europe and the United States.~      Selected Subject Cohorts:~        1. Selected subject cohort with criteria for SCD (without spontaneous prior ventricular~          sustained arrhythmia) and de novo ICD device treatment.~        2. Selected subject cohort with criteria for SCD and widely accepted standard cardiac~          resynchronization therapy (CRT) indication who received a de novo CRT-D device~          treatment.~        3. Selected subject cohort who are clinically expected to require >40% right ventricular~          pacing with a left ventricular ejection fraction (LVEF) <50%, any determined New York~          Heart Association (NYHA) Class, and receiving pacemaker (PM) or CRT pacemaker (CRT-P)~          therapy despite previous device history (de novo, box changes, system revisions or~          upgrades).~        4. Selected subject cohort with criteria for SCD fulfilling European Society of Cardiology~          (ESC) ICD or CRT-D therapy guidelines (2016) with an LVEF <35%, having 2 to 5 predefined~          SCD risk factors but do not have or had have a cardiac implanted defibrillator, CRT-D,~          PM, or CRT-P.~      The primary endpoint will report on the Composite rate of first appropriately treated~     ventricular arrhythmia (by anti-tachycardia pacing [ATP] or shock) or life-threatening~     symptoms associated to ventricular arrhythmia (defined as hemodynamic instability which~     requires treatment), whichever comes first under MADIT RIT Arm B or C programming conditions~     in a study population with a majority of Japanese subjects. This primary end point is~     assessed in the ICD/CRT-D implanted patient cohort.~      The all-cause mortality in subjects with a maximum of 3 risk factors (analyzed for MADIT II~     data) will be assessed in the PM/CRT-P patient cohort.~      The All-cause mortality will be assessed in the non-implanted subject cohort.~   "
29121|NCT03185819|"~     The purpose of this study is to assess the efficacy of a single (first) dose of 3 fixed doses~     of intranasal esketamine {28 milligram (mg), 56 mg, and 84 mg} compared with psychoactive~     placebo (oral midazolam) in rapidly reducing the symptoms of major depressive disorder (MDD)~     including suicidal ideation in participants 12 to less than 18 years of age who are assessed~     to be at imminent risk for suicide.~   "
29123|NCT03185793|"~     The objective of the study is to assess efficacy and safety of SHR4640 in subjects with~     hyperuricemia.~   "
29148|NCT03185468|"~     This is a Phase I/II and multicenter study designed to evaluate the efficacy and safety of~     4SCAR-T cells in participants with locally advanced or metastatic urothelial bladder cancer~     (UBC) who have no further treatment available.~   "
29124|NCT03185780|"~     Nearly a quarter of a million patients are diagnosed each year with tumors of the central~     nervous system, a third of them malignant. The most common malignant tumor of the brain is~     the high grade glioma( HGG), whose treatment begins with surgical resection of the tumor,~     followed by a combined chemo-radiation regimen, with the drug Temodal (temozolomide). This~     treatment is often accompanied by toxic effects (e.g., nausea, headache, constipation,~     weakness/fatigue, and others), with treatment of these effects limited in their effectiveness~     and safety. Complementary medicine treatments such as acupuncture and touch therapies~     (reflexology, Shiatsu, etc.) have been researched and found to be both safe and effective for~     some of the toxic effects of oncology treatment regimens.~      The present pilot study is set to examine the impact of complementary medicine on the toxic~     effects of the conventional treatment for HGG. The study will include 40 patients and will~     last for two years, during which patients will be treated with acupuncture and/or touch~     therapies, this in parallel to their chemo-radiation regimen. The primary study outcome will~     be the scores on four Patient-Reported Outcome Measures (PROMs): the Measure Yourself~     Concerns and Wellbeing (MYCAW) study tool; the Functional Assessment of Cancer Therapy, Brain~     Cancer (FACT-Br) questionnaire; the Edmonton Symptom Assessment Scale (ESAS); and the~     European Organization for Research and Treatment of Cancer Quality of Life Questionnaire~     (EORTC QLQ-c30). Secondary study outcomes will include the safety of the complementary~     medicine treatments, and adherence to the planned oncology treatment regimen, as measured by~     the Relative Dose Intensity (RDI) calculation.~   "
29125|NCT03185767|"~     the precise role of RNA in setting of this complication in systemic lupus erythematosus (SLE)~     is largely unknown~   "
29126|NCT03185754|"~     A multi-center prospective randomized trial in Taiwan to investigate whether sublobar~     resection, as compared to lobectomy, can offer equivalent clinical results to treat early~     non-small cell lung cancer.~   "
29127|NCT03185741|"~     The investigators will leverage increasingly available technologies to impart a Universal~     Medication Schedule (UMS) in primary care to help patients living with diabetes safely use~     and adhere to complex drug regimens. The UMS standardizes the prescribing and dispensing of~     medicine by using health literacy principles and more explicit times to describe when to take~     medicine (morning, noon, evening, bedtime). This eliminates variability found in the way~     prescriptions are written by physicians and transcribed by pharmacists onto drug bottle~     labels. The proposed intervention will standardize prescribing within an electronic health~     record (EHR) so all medication orders include UMS prescription instructions ('sigs') and~     patients receive a medication information sheet with their after-visit summaries.~     Additionally, to help patients remember when to take prescribed medicines we will link~     unidirectional short message service (SMS) text reminders to the EHR, delivering medication~     reminders to patients around UMS intervals.~        1. Test the effectiveness of the UMS, and UMS + SMS text reminder strategies compared to~          usual care.~        2. Determine if the effects of these UMS strategies vary by patients' literacy skills and~          language.~        3. Using mixed methods, evaluate the fidelity of the two strategies and explore patient,~          staff, physician, and health system factors influencing the interventions.~        4. Assess the costs required to deliver either intervention from a health system~          perspective.~   "
29128|NCT03185728|"~     This five-year study aims to improve childcare provider (CCP) reporting of suspected child~     abuse by means of an online learning module, iLook Out for Child Abuse. Using an interactive,~     video-based story-line (along with follow-up activities), iLookOut engages CCPs emotionally~     and intellectually to take the first step in addressing the epidemic of child abuse -which in~     the U.S. claims >680,000 confirmed victims annually. The consequences of child abuse can be~     devastating and long-lasting. The purpose of this study is to establish an evidence-based~     intervention that can help those who care for young children recognize and report suspected~     child abuse before irreparable harm occurs.~   "
29129|NCT03185715|"~     Multiple pregnancies are considered an ART complication. The only effective way to reduce its~     incidence is to transfer a single embryo. Nonetheless, there is some reluctance among the~     patients to accept this strategy. In IVF/ICSI programs, it has been demonstrated that, after~     receiving the information about the similar cumulative live birth rate after single embryo~     transfer (SET) and double embryo transfer (DET) and the obstetric and perinatal risks of~     multiple pregnancy, a significant number of patients opt for SET. Up to date, no comparable~     studies have been published in oocyte recipients. The aim of this study is to evaluate if the~     information given to the patients influence their preference on the number of embryos to be~     transferred. It also seeks to identify factors which determine the initial preference and~     factors which can explain a hypothetic change in this preference.~   "
29130|NCT03185702|"~     The investigators will conduct genetic comparisons between Turner Syndrome (TS) patients with~     and without Bicuspid Aortic Valve (BAV) to identify causative agents of BAV in people with~     TS.~      The investigators will correlate the patterns and prevalence of structural heart defects in~     TS women with emerging molecular data to identify patients who are at high risk for~     cardiovascular complications~   "
29131|NCT03185689|"~     In relation to rapid urbanization, demographic transition and childhood conditions obesity~     and type 2 diabetes (T2D) is increasing in an alarming rate in Africa. With an increase in~     the rate of diabetes in Ethiopia, responses to reduce its occurrence and delaying or~     preventing complications is not adequate. One of these strategies is empowerment of diabetes~     patients on self-care.~      The main objective of this project is to assess effects of phased and intensified DSME on~     psycho-social, clinical, and behavioral outcomes among adults with T2D in Ethiopia.~      An interventional two groups study design was employed to determine the desired effect of~     DSME. The study participants were selected randomly from adult T2D patients attending Jimma~     University Medical Center (JUMC) chronic illness follow-up clinic. Using the assumption of~     increasing the proportion of people with controlled blood glucose from 18% to 33% the sample~     was calculated 120 with participants in the intervention group and 120 in the comparison~     group.~      To reduce risk of contamination, we planned to vary the intervention and the comparison group~     based on their residence using kebele (the smallest administrative unit) for residents of~     Jimma town and woreda or district for those outside of Jimma town. Because of the~     inconvenience to vary days of appointment, where those supposed to come on Monday were coming~     on Tuesday and those supposed to come on Monday were coming on Tuesday, that created a high~     risk of mix-up of participants. Because of this reason, though the baseline was collected~     from February 2016 to May 2016, the intervention was delayed by five months and then started~     on November.~      Face to face group-based DSME has been given to the intervention group from November 2016 to~     April 2017. Then the participants will be further followed for three months to determine the~     effect of phased and intensified DSME on the control of BGL as measured by HbA1c.~      In order to make it culture-friendly educational materials were prepared with two widely used~     languages, Amharic and Afan Oromoo. First, the teaching materials were prepared in English~     then translated to Amharic and Afan Oromoo separately by bilingual experts. Then, different~     bilingual experts back translated to English. Finally, with these experts, common discussion~     was made and the final teaching materials were produced. The package of teaching materials~     includes booklets, fliers, and posters prepared in both languages.~   "
29134|NCT03185650|"~     Purpose: Characterize the depositional attributes of a specialized trans-nasal aerosol~     delivery device in healthy people using clinical measurements of mucociliary clearance.~      Participants: 10 Healthy non-pregnant volunteers aged 18 to 65 (inclusive) with a body mass~     index <30 kg/m² will enrolled.~      Procedures (methods): 7% hypertonic saline (HS) aerosol containing the radio tracer~     Tc99m-sulfur colloid will be delivered via the tPAD and compared to the well characterized~     PARI LC Star nebulizer using planar gamma scintigraphy (i.e. particle clearance). The~     fraction of sulfur colloid particles that clear over the ensuing 24 hours with each device~     will indicate the fraction deposited in conducting airways.~   "
29135|NCT03185637|"~     Background: Five billion people worldwide do not have access to safe, affordable surgical~     care. A significant proportion live in sub-Saharan Africa (SSA), where up to 50% of the~     population are children. There is limited literature on neonatal and paediatric surgery in~     SSA and children's surgery does not appear on any of the National Health Strategic Plans for~     the 47 independent countries across SSA.~      Objectives: To form a collaboration of surgeons and allied health professionals involved in~     children's surgery across SSA and collectively undertake the largest prospective cohort study~     of paediatric surgery in this region.~      Materials and Methods: Data will be collected via REDCap website on all patients with~     gastroschisis, anorectal malformation, appendicitis, inguinal hernia and intussusception,~     during a 1-month period of collaborators choice between October 2016 to April 2017, with a~     30-day follow up until the end of May 2017. Estimated study population: 1450 patients from 50~     institutions. Full ethical approval has been granted by the host centre; local ethical~     approval will be required at collaborating centres for participation. All collaborators will~     be co-authors.~      Primary outcome will be in-hospital all-cause mortality. Secondary outcomes will include~     post-intervention complications. Data will be collected on institutional facilities, patient~     demographics, duration from condition onset to presentation, peri-operative resuscitation,~     intervention and outcome.~      Differences in outcomes between SSA and benchmark data from high-income countries will be~     calculated using chi-squared analysis. Multi-level multivariate logistic regression analysis~     will be used to identify interventions and peri-operative factors associated with improved~     outcomes; p<0.05 will be deemed significant.~      Outcome: Results will be used to advocate for enhanced children's surgical services in SSA.~     We shall identify context-appropriate interventions associated with improved outcome. The~     collaboration will help to enhance research capacity in the region.~   "
29136|NCT03185624|"~     Some studies have shown that rifaximin is effective in the management of Crohn's Disease.~     Meanwhile, its adverse effect is tolerable. But no study has been conducted to assess its~     effect on preventing postoperative recurrence. Thus, we conduct a randomised controlled study~     to assess the effect of rifaximin on preventing postoperative endoscopic recurrence in~     Crohn's disease. The primary endpoint is the rate of endoscopic recurrence at 6 months.~   "
29137|NCT03185611|"~     Some studies have shown that rifaximin is effective in the management of Crohn's Disease.~     Meanwhile, its adverse effect is tolerable. But no study has been conducted to assess its~     effect on preventing postoperative recurrence. Thus, we conduct a randomised controlled study~     to assess the effect of rifaximin combined with thiopurine on preventing postoperative~     endoscopic recurrence in Crohn's disease, compared with thiopurine. The primary endpoint is~     the rate of endoscopic recurrence at 6 months.~   "
29138|NCT03185598|"~     To find the threshold of First operating room SBP above which MACE risk increases.~   "
29139|NCT03185585|"~     The COAST nutrition screening tool will be validated in 300 community-dwelling older adults~     in Florida.~   "
29140|NCT03185572|"~     Pulmonary hypertension is a common complication of chronic obstructive pulmonary disease~     (COPD). It is reported that over half of COPD patients develop pulmonary hypertension. COPD~     and pulmonary hypertension may have pathological or genetics interactions so that patients~     having both disorders tend to have poor prognosis. Echocardiography is widely used to detect~     pulmonary hypertension, but it's not accurate enough. Therefore, high-quality data reflecting~     the prevalence, disease course and outcome of pulmonary hypertension in COPD is very limited~     in China. The aim of the study is to detect pulmonary hypertension with right heart~     catheterization, describe its outcome in Chinese COPD patients and explore the underlying~     interaction mechanism.~   "
29141|NCT03185559|"~     This study will evaluate the clinical performance and safety of a self-administered abortive~     treatment for migraine headache using combined occipital and supraorbital transcutaneous~     nerve stimulator (Neurolief device, Relievion™).~   "
29142|NCT03185546|"~     Project 2 will evaluate the impact of very low nicotine content cigarettes, e-cigarette~     nicotine content, and e-cigarette flavoring on cigarettes smoked per day, nicotine exposure,~     puff topography, discomfort/dysfunction, other health-related behaviors, nicotine/tobacco~     dependence, biomarkers of tobacco exposure, intention to quit, compensatory smoking, other~     tobacco use, cardiovascular function, and perceived risk. Project 2 will also evaluate~     differences between conditions in compliance with product use and the ability to abstain from~     cigarette smoking when provided a financial incentive for abstinence from combusted tobacco.~     This is not a treatment program for smoking.~   "
29143|NCT03185533|"~     Emergency department (ED) crowding has become an international challenge in the recent~     decades.~      Length of stay (LOS) is a useful marker to monitor ED crowding. Searching for the possible~     causes and reducing barriers may have the greatest impact on EDLOS.~      Therefore, the investigators assembled a multidisciplinary team for improvement of the ED~     process, to undergo assessments of ED patient flow with the spirit of lean-sigma~     methodologies. The objectives of this study were to evaluate a Lean-sigma-based initiative to~     lessen EDLOS.~   "
29144|NCT03185520|"~     This study seeks to determine the clinical characteristics of young ESUS patients using~     diagnostic criteria of the Cryptogenic Stroke / ESUS International Working Group, and to~     determine the rates of stroke recurrence, death, and hospital readmission in a contemporary~     cohort of young ESUS patients during follow-up of up to 18 months.~   "
29145|NCT03185507|"~     Upon suffering a concussion, a neurometabolic cascade including an increase in glucose and~     oxygen demand occurs for up to 48 hours post-insult.5 This period of increased glucose and~     oxygen demand is coupled with a period of hyperperfusion and decreased cerebral blood flow.~     6-9 Cryotherapy in the musculoskeletal system has been shown to decrease tissue temperature,~     blood flow, oxygen and metabolic demands.10-17 Cryotherapy following moderate or severe~     traumatic brain injury has been demonstrated to decrease intracranial metabolic processes and~     oxygenation consumption.18-23 Although the benefits of cryotherapy have been established in~     moderate-severe TBI, the effects of superficial cranial cooling in individuals with and~     without concussion are unknown. The purpose of this randomized control trial is to evaluate~     the effects of superficial cryotherapy on cerebral blood flow and cognitive function in~     healthy, recreationally active young adults.~   "
29149|NCT03185455|"~     Women with hypertensive disorders of pregnancy need postpartum blood pressure (BP)~     surveillance to detect persistent hypertension. Various barriers result in only 30%~     attendance at postpartum BP visits. A more effective strategy is needed. Women with~     hypertension of pregnancy will be randomized to either text-based monitoring or office~     visits. Those randomized to the intervention will receive a BP cuff and text in their BP to~     an automated, clinician derived, HIPAA compliant text-based algorithm.~   "
29150|NCT03185442|"~     Evaluation of central (cerebral) effects of Pulsed RadioFrequency (PRF) on the lumbar DRG~     (Dorsal Root Ganglion), using fMRI (functional Magnetic Resonance Imaging ). Feasibility~     study (after which an interim analysis is done): 5 subjects in order to detect measurable~     central effects inducted by PRF on DRG, follow up study 20. Total amount of subjects 25.~   "
29151|NCT03185429|"~     The goal of this study is to learn about the safety and tolerance of autologous TSA-DC cell~     and evaluate the efficacy and feasibility of the cell therapy compared to the patients' past~     standard regimen. 20 gastrointestinal solid tumors subjects failed from at least one systemic~     therapy will be enrolled into the trial and receive a succession of treatment of TSA-DC~     vaccine.~   "
29152|NCT03185416|"~     A mixed methods randomized control trial assessing the impact of early palliative care~     incorporation in liver cancer and metastatic colorectal cancer on caregiver well-being,~     patient physical and psychosocial outcomes, and health services utilization.~   "
29153|NCT03185403|"~     Continuous Paravertebral block (PVB) was reported to provide less episodes of hypotension~     than continuous thoracic epidural block (TEB). The maintenance of optimal tissue perfusion is~     essential for esophageal anastomosis in patients undergoing oesophagectomy. the aim of this~     study is to compare Hemodynamic effect of continous PVB compared to TEB , in patient~     undergoing oesophagectomy with laparoscopy and thoracotomy.~   "
29154|NCT03185390|"~     A periampullary lesion may be begin as duodenal adenoma, ampullary adenoma, gall stone~     pregnant ampulla, Stricture, or periampullary lipoma, or malignant as pancreatic ductal~     adenocarcinoma, distal CBD cholangiocarcinoma, ampullary carcinoma and periampullary duodenal~     adenocarcinoma, pancreatic carcinoma.~      The aim of the study is to detect incidence of different types of periampullary lesions~     detected by ERCP in Assuit University Hospital and the role of ERCP in early detection,~     diagnosis and management and diagnostic accuracy and sensitivity of biopsy and brush cytology~     taken by ERCP in a period of 1 years starting from June 2017 to June 2018.~   "
29155|NCT03185377|"~     Chronic obstructive pulmonary disease (COPD) is closely related to venous thromboembolism~     (VTE). But it is difficult to identify VTE in COPD patients in clinical practice. Therefore,~     the prevalence data of PTE in COPD is limited. Pulmonary thromboembolism (PTE) is an~     important factor effecting patients outcomes, but existing researches only have short~     follow-up time less than 1 year. This study aim to develop an early detection system of PTE~     in COPD and explore the disease course and prognosis.~   "
29156|NCT03185364|"~     Over half of chronic obstructive pulmonary disease (COPD) patients develop pulmonary~     hypertension. The current therapy focuses only on the basic disease and there are a lot of~     controversies about the use of PAH target therapy in group 3 pulmonary hypertension. Our~     study is to explore whether sildenafil, a pulmonary arterial hypertension (PAH) target drug,~     could be efficient and safe in improving symptoms and survival of severe pulmonary~     hypertension caused by COPD.~   "
29157|NCT03185351|"~     An effective brachial plexus block (BPB) provides a useful alternative to general anesthesia~     for upper arm surgery producing complete muscular relaxation. It provides surgical anesthesia~     in upper extremity surgery, post-operative analgesia and chronic pain management. In addition~     to surgical procedure on conscious patients and early eating after the procedure make~     regional anesthesia more attractive.~      Brachial plexus block also maintains stable intraoperative hemodynamic and associated~     sympathetic block. The sympathetic block decreases postoperative pain, vasospasm and edema.~     The nerve of brachial plexus may be blocked anywhere along its course. The approach for~     blocking brachial plexus nerve is interscalene, supraclavicular, infraclavicular and axillary~     approach.~      Supraclavicular approach for blockade of the brachial plexus is the most commonly used~     approach in providing surgical anesthesia. In recent years, the technique has gained~     importance as regional anesthetic technique for surgical, diagnostic and therapeutic purposes~     in interventional pain management. It includes blocking of the brachial plexus where it is~     most compactly arranged, with fewer requirements of the anesthetic solution and rapid onset~     of action. Supraclavicular nerve block is technically easy to perform because of reliable and~     fixed landmark but association of pneumothorax is a profound complication.~      The extent of blockade following injection into the sheath surrounding the brachial plexus~     may depend on the volume and concentration of local anesthetic (LA) used. Because of~     bupivacaine long duration of action, it is used most frequently among local anesthetics for~     BPB.~      Inevitably, the effects of single-injection BPB dissipate after several hours unmasking the~     moderate-to-severe pain of the surgical insult. Efforts to prolong BPB duration by increasing~     LA dose are limited by their narrow therapeutic window and indeed may not be effective as~     recent studies have demonstrated equivalent analgesic duration with volumes as low as 5 ml.~      Midazolam is known to produce antinociception and potentiate the effect of LA when given in~     neuraxial block. It produces this effect by its action on Gamma Aminobutyric Acid-A (GABA-A)~     receptors and also on the peripheral nerves which contain these receptors.~      Several studies showed midazolam to be effective when used in intrathecal, epidural and~     caudal blocks and now recently midazolam with bupivacaine has been found to improve analgesic~     characteristics in peripheral blocks compared to bupivacaine alone. Due to the high blood~     concentration of benzodiazepine through conventional routes and profound sedation, proper~     assessment of analgesic effect was difficult to obtain. With the advent of the less toxic~     water soluble benzodiazepine (midazolam), it became possible to use it directly over the~     nerve tissues.~   "
29158|NCT03185338|"~     Background:The lack of physical activity and increasing time spent in sedentary behaviours~     during childhood place importance on developing low cost,easy-to-implement school-based~     interventions to increase physical activity among children. The PREVIENE Project will~     evaluate the effectiveness of five innovative, simple, and feasible interventions(active~     commuting to school, Physical Education lessons, active school recess physical activity,~     sleep health promotion, and an integrated program incorporating all 4 interventions) to~     improve physical activity, fitness, anthropometry, sleep health, academic achievement,and~     health-related quality of life in primary school children.~      Methods:A total of 350 children (grade 3; 8-9 years of age) from six schools in Granada~     (Spain) will be enrolled in one of the 8-week interventions (one intervention per school; 50~     children per school) or a control group (no intervention school; 50 children). Outcomes will~     include physical activity (measured by accelerometry), physical fitness (assessed using the~     ALPHA fitness battery), anthropometry (height, weight and waist circumference), sleep health~     (measured by accelerometers, a sleep diary, and sleep health questionnaires), academic~     achievement (grades from the official school's records), and health-related quality of life~     (child and parental questionnaires).To assess the effectiveness of the different~     interventions on objectively measured PA and the other outcomes, the generalized linear model~     will be used.~      Discussion: The PREVIENE Project will provide the information about the effectiveness and~     implementation of different school-based interventions for physical activity promotion in~     primary schoolchildren.~      Keywords:children, physical activity, school,active commuting, Physical Education, school~     recess, sleep health, fitness, academic achievement, health-related quality of life.~   "
29197|NCT03184831|"~     28 recruited patients indicated for sinus floor elevation with simultaneous implant placement~     . they were divided into two groups. first group was assigned for placement of deproteinized~     bovine bone solely, while the other group was assigned for the placement of mixture of~     injectable platelet rich fibrin with deproteinized bovine bone into the sinus after implant~     placement.~   "
49268|NCT02922036|"~     This study is a prospective, multi-center, randomized, controlled, double blinded, pivotal~     trial to study the safety and efficacy of the WiSE-LV System for Cardiac Re-synchronization~     Therapy.~   "
29159|NCT03185325|"~     Lymphomas are hematological malignancies, which are divided into non-Hodgkin lymphoma and~     Hodgkin lymphoma. Non hodgkin lymphoma is a lymphoma-derived malignancy that makes up about~     90% of all malignant lymphoma. According to its origin, non hodgkin lymphoma is classified~     into B-cell non hodgkin lymphoma and T-cell non hodgkin lymphoma. The most common types are~     follicular lymphoma, and diffuse large B-cell lymphoma. Lymphomas are types of cancer that~     develops from lymphocytes, a type of white blood cell. Diagnosis is by examination of a bone~     marrow or lymph node biopsy. Non hodgkin lymphoma mortality has increased in recent years and~     has become the seventh most frequently occurring cancer.~   "
29160|NCT03185312|"~     The Janus kinase/signal transducer and activator of transcription (JAK-STAT) cytokine~     signaling pathway is an emerging area of interest in dermatology, and emerging evidence~     suggests that this pathway may play a crucial role in pathogenesis of inflammatory skin~     disorders.~      Recent advances on the role of cytokines in the pathophysiology of immune mediated~     inflammatory diseases lead to the understanding that many pro inflammatory interleukins use~     JAK/STAT components for signal transduction .~   "
29161|NCT03185299|"~     High quality bowel preparation is essential for successful colonoscopy. This study aimed to~     assess the impact of reinforced education by Video on the quality of bowel preparation. This~     prospective, endoscopist-blinded, randomized, controlled study was conducted. Reinforced~     education groups received additional education via reminders by video 2 days before~     colonoscopy. The primary outcome was the quality of the bowel preparation according to the~     Boston Bowel Preparation Scale (BBPS). The secondary outcomes included polyp detection rate~     (PDR), adenoma detection rate (ADR), tolerance, and subjective feelings of patients.~   "
29162|NCT03185286|"~     This study aims to use 3D-printed personalized metal implants for bone defect surgeries in~     order to reduce pain of the patients.~   "
29163|NCT03185273|"~     This is a prospective cohort study building upon the existing cohort study on the~     effectiveness of the Trekkers Family Enhancement Scheme. This study will sample 200~     low-income parent-child pairs and follow them up for 24 months with yearly assessment on~     parental stress and child health using both subjective measures and objective physiological~     parameters. Additional data on parenting style, neighbourhood cohesion, child physical~     assault and neglect potential, parental mental health and HRQOL and family disharmony will~     also be collected at each assessment time point for testing mediating and moderating~     mechanisms between parental stress and child health. The baseline assessment will be carried~     out in 2016-17 with three repeated assessments after 6 months, 12 months, and 24 months.~   "
29164|NCT03185260|"~     The aim of the registry is to collect laypeople's performance after a BLS/AED course carried~     out with the use of feedback devices.~   "
29165|NCT03185247|"~     The proposed intervention is focused on developing and implementing a psychological approach~     incorporated into a group-based outpatient intervention for pediatric autonomic dysfunction.~     The investigators hypothesize that their intervention will result in improvements in the~     transdiagnostic mechanisms specifically targeted by components of their intervention~     including sleep, information processing, and youth/parent experiential avoidance.~   "
29166|NCT03185234|"~     The objective of the clinical trial is to investigate whether weak transcranial direct~     current stimulation (tDCS) can ameliorate the motor cognitive deficit apraxia during stroke~     rehabilitation. Stroke patients with apraxia will either receive a real stimulation or a sham~     stimulation (placebo) for 10 minutes at a time on 5 consecutive days during their in-patient~     stay in a rehabilitation center. Additionally, motor tasks are performed before and after the~     stimulation. The effect of the weak current stimulation on motor function is assessed 3-4~     days after the last stimulation and 3 months after enrollment.~   "
29167|NCT03185221|"~     Study purpose: This study is a prospective, randomized, controlled multicenter clinical~     research, which is to assess the effect of Cordimax and Xience V drug-eluting stents as they~     dealing with all kinds of complex lesions in the real world.~      Study group Experimental group: Cordimax® Rapamycin Eluting Coronary Stent System Control~     group: XIENCE V® Everolimus Eluting Coronary Stent System~   "
29168|NCT03185208|"~     Alzheimer's disease (AD) is the most common cause of dementia in adults 65 years and older.~     AD leads to a complete loss of memory and independent function, and presently there is no~     cure. Many studies suggest that lithium treatment may delay dementia onset or slow its~     progression. However, more research is needed to understand the extent of its anti-dementia~     properties if it will be deployed broadly in the general population. This study will examine~     whether lithium has anti-dementia properties in older adults who have mild cognitive~     impairment and are at risk of becoming demented.~   "
29169|NCT03185195|"~     This study is conducted to evaluate the absolute bioavailability, metabolism and elimination~     pathways of AQX-1125 in healthy male and female subjects.~   "
29170|NCT03185182|"~     The main objective is to study whether imaging detection of the biomarker DAT can be used to~     detect kidney tumors identified by computer tomography (CT), which are pathologically~     assesses as being of the clear cell subtype.~   "
29171|NCT03185169|"~     The impact of treatment for GSM on the quality of life will be examined for postmenopausal~     women (defined as last menstrual period > 1 year ago or 6 months ago with FSH >40) who have~     been diagnosed with breast cancer.~   "
29172|NCT03185156|"~     This is a randomized, placebo-controlled trail, the objective of this study is observation~     the effect of sub hypnotic dose of propofol for prevention of nausea and vomiting induced by~     hemabate during spinal anesthesia for elective cesarean section. The primary outcome is the~     presence of post-delivery intra-operative nausea and vomiting in parturients. The patients~     demographic characteristics, blood pressure, sensory block level, and the medications will be~     collected.~   "
29173|NCT03185143|"~     This proof-of-concept study compares side-by-side ALLOD-2 to sumatriptan in the acute~     treatment of migraine.~      The investigational product (ALLOD-2), is a combination of two marketed drugs. Both drugs are~     used at much lower doses than the doses used for the approved indications.~      The combination is a First-in-Class drug due to its new and unique mechanism of action.~   "
29217|NCT03184571|"~     This is an open label, single arm, multi-centre phase II study to assess the anti-tumour~     activity and safety of bemcentinib (BGB324) in combination with pembrolizumab in up to 48~     patients with previously treated advanced adenocarcinoma of the lung. The study will utilise~     an extension of Simon's 2-stage design. The primary objective is objective response rate.~   "
29174|NCT03185130|"~     Migraine headache has a 1-year period prevalence in the US of 11.7% and accounts for~     approximately 1.2 million migraine visits to US emergency departments per year . There are~     numerous studies that discuss treatment for migraine and other benign headaches within the~     emergency department (ED), however, there are very few that discuss specifically the use of~     intravenous fluids (IVF) for headache treatment. Many of these studies look at various~     options for treating migraine and other benign headaches: treatment options include dopamine~     antagonists, opioids, non-steroid anti-inflammatory drugs (NSAIDs), triptans, anti-epileptics~     and ergot derivatives. Comparisons have been done between many of these treatment options~     with dopamine antagonists appearing to be the most effective, compared to other treatments~     The dopamine antagonist with the most evidence and availability for benign headaches is~     prochlorperazine. Given that IVF administration is a common part of treatment regimen for~     benign headache patients in the emergency department and given the lack of randomized trials~     in adults, the investigators aim to study the use of IVF on pain reduction in headache~     patients in the adult ED. There has been one randomized trial in pediatrics that shows IVF~     may help in patients with migraines, whereas the adult literature has no randomized control~     trials and a review of data shows that fluids do not help relieve pain in migraine headache~     patients. This study will include both adult and pediatric patients presenting to the~     Emergency Department with complaint of benign headache.~   "
29175|NCT03185117|"~     At the Ohio State University, and across the country, surgical patients admitted to the~     hospital are over-prescribed a significant amount of opioid medications upon discharge to~     home. Recent studies reveal that a large percentage of patients prescribed opioid medications~     after surgery have approximately half of the prescribed medication left over. This study aims~     to evaluate reported opioid use after surgery in patients undergoing major orthopedic surgery~     in order to better approach the issue with current opioid use and abuse trends while still~     providing adequate medical care and pain management to patients~   "
29176|NCT03185104|"~     This study measures and compares the effect of silver diamine fluoride (SDF) on caries~     increment in removable partial denture wearers. Half of the participants will SDF and while~     the other half will receive placebo.~   "
29177|NCT03185091|"~     To evaluate the effect of rapid ventricular pacing on the oxygenation of the brain in~     patients scheduled for cerebral aneurysm clipping surgery or arteriovenous malformation~     surgery.~   "
29178|NCT03185078|"~     The aim of this study is to observe the changes in the combined ESWT application and~     physiotherapy program in the frozen shoulder pathology associated with diabetes. Different~     treatment approaches will try to identify the most effective treatment method. Changes in~     muscle tone will be observed with ESWT treatment. For the first time placebo-controlled~     research is being conducted with different doses of ESWT in our country and in the World~     literature. In this way the lower floor of the further work to be done will be established.~   "
29179|NCT03185065|"~     Randomized, placebo-controlled, crossover, 4-sequence, 4-period, double-blind (participants~     and investigators), multicenter trial of 3 commonly used medications for treatment of~     MS-related fatigue (amantadine, modafinil, methylphenidate) versus placebo in fatigued~     subjects with MS defined by McDonald Criteria.~   "
29180|NCT03185052|"~     Over the past years, arterial closure systems have tended to replace manual compression to~     ensure hemostasis at femoral artery puncture points. Arterial closure systems reduce~     hemostasis and patient immobilization times, thus enabling early resumption of walking. These~     devices have contributed extensively to the development of outpatient stays for cardiology,~     vascular and neuro-radiology procedures.~      According to certain studies however, it would appear that arterial closure devices do not~     present any greater benefits than manual compression in terms of hemostasis and~     complications. Moreover, the use of increasingly small diameter instruments would tend to~     render manual compression sufficient. Finally, the use of these devices generates additional~     costs.~      The purpose of our prospective study is to evaluate the feasibility and safety of same-day~     discharge after manual compression in patients treated for peripheral artery disease by~     endovascular technique with 5F sheath.~   "
29181|NCT03185039|"~     Prospective research of Matrix Metalloproteinases (MMP) 2 and 9 as predictive biomarkers in~     metastatic kidney cancer patients treated with 2 anti angiogenic agents (Sunitinib or~     Pazopanib).~   "
29182|NCT03185026|"~     The aims of the recent World Health Organization report, highlighting that every 40 seconds a~     person dies from suicide somewhere in the world, are to increase awareness on the public~     health significance of suicide and make suicide prevention a greater priority within the~     global public health agenda. Across age groups, less than half of individuals at elevated~     suicide risk interface with some form of mental health services. Several barriers to~     help-seeking have been identified (maladaptive coping, lack of perceived need, beliefs about~     treatment effectiveness, fear of hospitalization or mistrust of providers, stigma...), which~     are key targets in knowledge-based interventions on suicide. Psychoeducational programs have~     shown effectiveness in prevention relapse for several mental disorders such as schizophrenia,~     bipolar disorder or recurrent depressive disorder, improving treatment adherence and~     self-confidence in coping with symptoms of the disease. They are highly recommended for~     addressing adherence problems in patients with serious and persistent mental illness. Only~     one team has published a study protocol for a controlled trial assessing a 10 group sessions~     psychoeducational program for prevention in patients having a suicide history, in a one-year~     follow-up. Interestingly, diagnosis-mixed group psychoeducation have shown superiority than~     an unspecific intervention add-on routine care, on the suicide prevention and compliance for~     severe psychiatric disorders. Those psychoeducational-specific elements are namely the~     interactive transfer of illness and treatment-related knowledge and management/coping -~     cognitive/behavioral - strategies, as defined by the National Institute for Health and Care~     Excellence)-Guidelines (NICE). Notably, as several psychiatric diagnoses are associated with~     suicidal behavior (SB), coping strategies have to target processes that overlap among these~     psychiatric disease, as well as suicidal vulnerability. Acceptance and Commitment Therapy~     (ACT), a third wave behavioral therapy, targets experiential avoidance and psychological~     flexibility, at the core of psychiatric disorders. Interestingly, in patients with a history~     of suicidal depression, training in mindfulness can help to weaken suicidal thinking~     associated with depressive symptoms , and thus reduce an important vulnerability for relapse~     to suicidal depression. ACT would also increase intrinsic motivation for daily life action~     (i.e. reasons for living and acting). Then, the functional analysis (matrix) used in ACT~     seems to be an useful tool to help patient in decision making, a neuropsychological factor~     impaired in suicidal patients. Finally, acceptance and commitment group therapy has suggested~     effectiveness in reducing intensity and frequency of suicidal thoughts, through improvement~     in acceptance, in high risk suicidal patients. As compared with ACT, Dialectical behavior~     therapy (DBT) teaches added distress tolerance in view of survive the crisis. DBT is the most~     validated therapy for borderline personality disorder, the mental disorder the most~     associated with SB . Notably, group skills training is the most effective component in DBT~     for preventing suicidal behavior in borderline patients with high suicidal risk. Furthermore,~     interventions based on positive psychology have suggested efficacy in reducing depressive~     symptoms and suicidal ideation. Notably, in a recent pilot study, positive psychology~     exercises delivered to suicidal inpatients were feasible and associated with short-term gains~     improvement in optimism and hopelessness. Finally, as altered social link and sense of~     belonging have been widely involved in SB, relationship skills are an interesting positive~     psychology area for suicide prevention program.~      Psychoeducational program integrating knowledge as well the last innovating~     cognitive-behavioral coping strategies for SB is of major interest in suicide prevention.~      Investigators developed the first French program of suicide psychoeducation called PEPSUI.~     The aim of this innovating program is to teach patients the more recent knowledge about~     suicidal behaviour (SB) and effective treatments, through didactic and interactive sessions.~     Thus, the objective is to conduct the patients to become experts and actors of their disease,~     increasing adherence to treatment. Besides, the patients will experiment the last innovating~     psychological skills to cope with unpleasant emotions and thoughts (including suicidal~     thoughts), distress tolerance skills and crisis strategies, and identify personal purpose in~     life and learn positive psychological skills in order to anchor with meaningful and pleasant~     components in life. Thus, this program will include skills from ACT, DBT and positive~     psychology. Finally, this primary care research is about a program which aim at improving~     accessibility to mental health services, care adherence and continuity for suicidal patients.~   "
29183|NCT03185013|"~     HPV-301 is a prospective, randomized, double-blind, placebo controlled Phase 3 study to~     determine the efficacy, safety, and tolerability of VGX-3100 administered by intramuscular~     (IM) injection followed by electroporation (EP) delivered with CELLECTRA™ 5PSP in adult women~     with histologically confirmed cervical high grade squamous intraepithelial lesion (HSIL)~     (cervical intraepithelial neoplasia grade 2 [CIN2] or grade 3 [CIN3]) associated with human~     papillomavirus (HPV) 16 and/or HPV-18.~   "
29184|NCT03185000|"~     Crohn's Disease (CD) is a condition that causes inflammation of the digestive system or gut.~     Crohn's can affect any part of the gut, though the most common area affected is the end of~     the ileum (the last part of the small intestine), or the colon.~      Crohn's is a chronic condition. This means that it is ongoing and life-long, although~     patients may have periods of good health (remission), as well as times when symptoms are more~     active (relapses or flare-ups).~      Current available therapies frequently fail to maintain long-term remission and may be~     complicated by significant side effects.~      There is an unmet medical need for novel therapies. Cellular therapies are emerging as~     potentially attractive therapeutic strategies.~      The TRIBUTE trial will use autologous regulatory T cells (Tregs) expanded in vitro.~      It is hoped that the administration of this treatment to patients with active CD will change~     the immune responses in the gut and reduce bowel wall inflammation.~   "
29207|NCT03184701|"~     End-Stage Liver Disease (ESLD) is one of the ten leading causes of death in US. It is marked~     by episodic acute exacerbations of the underlying liver disease which often leads to severe~     symptoms, poor quality of life, mental deterioration and repeated hospitalizations.~      The overall purpose of this project is to introduce a telehealth based intervention~     (involving remote monitoring of symptoms and cognitive function initiated at the time of~     discharge of ESLD patients. This will support enhanced clinical care and improve~     self-management in ESLD population. In addition, it will reduce healthcare utilization,~     improve medication adherence and overall health outcomes~   "
29185|NCT03184987|"~     Despite availability of treatments and published guidelines, subjects may have asthma that is~     inadequately controlled. GlaxoSmithKline is currently developing a once-daily 'closed' triple~     therapy of an Inhaled Corticosteroids/Long-Acting Beta-2-Agonists/Long-Acting Muscarinic~     Antagonist (ICS/LAMA/LABA) combination (Fluticasone Furoate/Umeclidinium Bromide/Vilanterol~     Trifenatate [FF/UMEC/VI]) in a single device, with the aim of providing a new treatment~     option for the management of asthma by improving lung function, health-related quality of~     life (HRQoL) and symptom control over established combination therapies. This study has 3~     study periods: Run-in, Treatment period and a Follow-up period. Eligible subjects who meet~     the pre-defined criteria at screening (Visit 1) will enter into a 2-week run-in period.~     Subjects will continue their pre-screening inhaled medications for asthma (ICS+LABA or~     ICS+LABA+LAMA) without any change in regimen/dosage until day before Visit 2. At Visit 2~     subjects will be allocated to either FF/UMEC/VI 100/62.5/25 or FF/UMEC/VI 200/62.5/25~     micrograms (mcg) treatment depending on the asthma control status for 52 weeks. Switching~     medication from FF/UMEC/VI 100/62.5/25 to FF/UMEC/VI 200/62.5/25 will be permitted in~     accordance with the control status of the subject assessed by Asthma Control Questionnaire~     (ACQ)-7 at Week 24 of the treatment period. A follow-up visit will be conducted for~     approximately 1 week. Subjects will be provided with salbutamol as a rescue medication~     throughout the study.~   "
29186|NCT03184974|"~     During thoracic surgical procedures, while ventilating with a protective tidal volume, an~     open lung approach consisting of a recruitment maneuver followed by an individualized~     positive end-expiratory pressure (PEEP) titrated to best respiratory system compliance~     (Open-lung PEEP, OL-PEEP) would decrease driving pressure. To test this hypothesis, we~     performed a multicenter observational study in 17 Spanish teaching hospitals of patients~     undergoing one lung ventilation (OLV). In addition, we analyzed the association between the~     driving pressure and the prevalence of postoperative pulmonary complications (PPCs), and~     finally the association between the individualized PEEP and relevant patient preoperative or~     intraoperative variables.~   "
29187|NCT03184961|"~     Lung recruitment maneuver induces a decrease in stroke volume, which is more pronounced in~     hypovolemic patients. The authors hypothesized that the changes of dynamic variables through~     lung recruitment maneuver could predict preload responsiveness in pediatric patients with~     lung protective ventilation~   "
29188|NCT03184948|"~     This study exploits the distribution of low-cost high-quality phototherapy devices~     (Brilliance by D-Rev) to public hospitals in Rwanda to assess whether the provision of~     improved technology improves health care for infant jaundice. Specifically, the investigators~     are interested in measuring whether the provision of an additional high-quality phototherapy~     device, a known effective treatment for jaundice, successfully translates into improved care~     of neonatal jaundice in Rwanda where the burden of jaundice is particularly high.~   "
29189|NCT03184935|"~     The purposes of the study is to determine the safety and efficacy of human umbilical cord~     mesenchymal stem cells (hUC-MSC) in treating Myelodysplastic Syndrome patients.~   "
29190|NCT03184922|"~     Study Aims and Objectives:~      To investigate the following null hypothesis: that there is no difference in clinical and~     functional outcome when comparing outcomes of Anterior Cruciate Ligament (ACL) reconstruction~     when comparing femoral side graft fixation with either a fixed versus an adjustable~     suspensory loop system.~      The research team will achieve this aim by:~        -  Enrolling 150 patients into this study over a period of 2 years and 8 months~        -  Carrying out a prospective randomised study looking at the subject matter over a period~          of 5 years and 8 months~        -  Analysing patients functional status pre and post-surgery using patient generated~          questionnaires~        -  Quantitatively measuring knee joint laxity using the KT1000 testing device at the 3, 6~          and 12 month post-surgery time frames~        -  Collating the data received into a spread sheet for analysis by a professional~          statistician.~      It is not uncommon to tear the anterior cruciate ligament (ACL) particularly during sporting~     activities. Younger and sportier patients will often have this ligament reconstructed so as~     to allow them to return to sport with a stable knee joint that they feel they can trust.~      Various surgical techniques exist to perform ACL reconstruction. In Exeter, the favoured~     technique is to reconstruct the ligament by taking two of the hamstring tendons from the back~     of the knee and creating a graft with these, passing them through a bony tunnel to replace~     the torn ACL. On the shin bone side of the knee the graft is fixed in place using a screw. On~     the thigh bone side, the graft is attached to a device known as a suspensory loop.~      The length of the graft and the length of the tunnel in the thigh bone vary from patient to~     patient. It is important to get a good length of the graft material in both the shin and~     thigh bones so as to give the best chance of the graft attaching to the surrounding bone.~     With the fixed loop system, once the metal button attached to the outer thigh bone is in~     place, the length of the loop cannot be adjusted. Thus the amount of hamstring graft in~     either end of the bony tunnel cannot be changed. One potential advantage of an adjustable~     loop system is that the amount of graft in either end of the bone tunnel can be altered to~     ensure sufficient graft is accurately placed.~      The research team are planning to run this study to identify which type of loop system gives~     the best outcome for patients, examining the results in different ways including~     questionnaires to measure how well the patients feel their knee is performing, and specific~     tests to measure knee function.~      If patients consent to be in the study, they will be randomly allocated to receive one of the~     2 ACL reconstruction options above and their progress monitored for 2 years after the~     operation. All aspects of surgical care will be as routine practice apart from the decision~     to fix the graft to the thigh bone with an adjustable or fixed suspensory loop.~   "
29191|NCT03184909|"~     Tulsi and its effects on facilitative cognitive enhancement through lowering levels of stress~     and anxiety. A randomised placebo-controlled clinical trial.~   "
29192|NCT03184896|"~     Hip fracture is a osteoporosis-related fracture with higher mortality, and is a major public~     health issue in China. The British Orthopedic Association and the British Geriatric Society~     have published the UK Blue Book, which summarizes current evidence and best practice in the~     hip fracture care and secondary prevention, but this kind of standardized practice in hip~     fracture care is not yet existed in China. The Blue Book standards will be used as the most~     contemporary evidence-based guidelines for management of hip fracture.This study is to~     prospectively examine the barriers and facilitators in the current management of hospital in~     China by comparing the Blue Book standards.~   "
29193|NCT03184883|"~     comparing the effect of conventional mandibular single denture with flexible mandibular~     single denture on tissue and patient's satisfaction~   "
29194|NCT03184870|"~     This study will evaluate the safety profile, tolerability, PK, PD, and preliminary efficacy~     of BMS-813160 in combination with either chemotherapy or nivolumab in participants with~     metastatic colorectal and pancreatic cancers.~   "
29195|NCT03184857|"~     Two stage sinus lifting using Nano hydroxyapatite particles [Nanostreams] versus Deprotenized~     bovine bone allograft [Tutogen] : Randomized clinical trial.~      comparing between Height of new bone formation, Bone area percent( Histomorphometric)~   "
29196|NCT03184844|"~     This is an exploratory experiment, aims to explore the effective and safety of thalidomide in~     the treatment of TI to improve the hemoglobin level, improve the quality of life, reduce~     blood transfusion, so as to avoid the adverse reactions caused by transfusion,60~100 patients~     will be enrolled.~   "
29198|NCT03184818|"~     Pharmacists in some Canadian jurisdictions have recently been granted the ability to~     prescribe for uncomplicated urinary tract infections (UTIs). Therefore, the purpose of this~     study is to assess the impact that community pharmacists can have on the management of UTIs.~      Pharmacists will identify potential study participants (patients) when they either present~     with symptoms of a UTI (such as difficulty or painful urination, increased frequency or~     urgency of urination) without a prescription for an antibiotic from another health care~     provider, or when they present with a prescription for an antibiotic from another health care~     provider to treat a UTI. For patients who consent to participate in the study, the pharmacist~     will screen for eligibility and assess for appropriateness of treatment.~      If the patient does not already have a prescription for an antibiotic from another health~     care provider, the pharmacist will prescribe this for them if they meet certain criteria. If~     they do already have a prescription from another health care provider, the pharmacist will~     assess the appropriateness of the prescription and work with the patient to potentially~     change it to make it more appropriate, if necessary. If the pharmacist identifies any~     complicating factors that require a physician's assessment, the patient will be referred to~     their physician. The enrolled patients will also have a 2-week follow-up to assess for~     resolution of symptoms, unintended effects, and adherence to the treatment regimen. All data~     will be collected in a web-based registry that will maintain the patient's confidentiality~     outside of the pharmacy (i.e. patient initials, date of birth, and study identification (ID)~     number will be the only patient identifiers collected by the researchers). A patient~     satisfaction survey will also be administered via email.~   "
29199|NCT03184805|"~     Most previous trials support the absolute increase in bleeding risk with perioperative~     administration of antiplatelet. Furthermore, recent studies demonstrated that perioperative~     major bleeding may be related to increase cardiovascular risk. The investigators will compare~     the efficacy and safety of continuing versus stopping antiplatelet therapy during~     perioperative period in patients underwent PCI(Percutaneous Coronary Intervention) with next~     generation DES(Drug Eluting Stent).~   "
29200|NCT03184792|"~     Stimulation of the spinal cord may induce the growth and reorganization of neural pathways~     leading to the re-animation of paralyzed limbs. Growing evidence indicates that electrical~     spinal cord stimulation improves motor functions immediately via modulating the excitability~     of spinal circuitry in patients with spinal cord injury. Recently, a novel, non-invasive,~     well-tolerated and painless transcutaneous electrical stimulation strategy was demonstrated~     to be effective for improving lower limb motor function in healthy individuals and in~     patients with spinal cord injury. The investigators hypothesize that transcutaneous cervical~     electrical stimulation can enhance conscious motor control and functions of hand and arm via~     neuromodulation of spinal network.~      This study is a prospective efficacy trial of transcutaneous cervical electrical stimulation~     for improving upper limb function in patients with traumatic or degenerative cervical spinal~     cord injury. Transcutaneous electrical spinal stimulation device is not regulated by the~     United States Food and Drug Administration for treatment of spinal cord injury.~      The interventions include either transcutaneous cervical spinal electrical stimulation~     combined with physical therapy or physical therapy only. The order of the interventions will~     be randomized for each subject in a delayed cross-over design. Total duration of the study is~     6 months, including 4 weeks baseline measurements, 8 weeks intervention and 12 weeks~     follow-up. Both immediate and lasting improvements in hand motor and sensory function via~     transcutaneous cervical spinal stimulation will be evaluated.~   "
29201|NCT03184779|"~     The main objective of the study is to investigate if a video intervention can help increase~     knowledge, decrease risky behaviours on the hill, and reduce injury risk in students who~     participate in ski and snowboard school programs. The study design is a cluster randomized~     controlled trial where participating schools will be randomized into either an intervention~     or control group. The intervention video will contain an injury prevention and safety~     promotion component for skiing or snowboarding. The control group will receive the standard~     orientation video that many schools typically provide for students prior to their~     ski/snowboard outings in previous years.~   "
29202|NCT03184766|"~     This comparative pharmacokinetic study is being conducted to provide supporting evidence for~     inclusion in dossiers to regulatory authorities for an Article 8(3) of Directive 2001/83/EC~     abridged application for ibuprofen and pseudoephedrine liquid capsules (200 mg ibuprofen & 30~     mg pseudoephedrine).~   "
29203|NCT03184753|"~     The primary objectives are to evaluate the safety and efficacy of infusion of autologous~     ovarian cancer immunogene-modified T cells (OC-IgT cells).~   "
29204|NCT03184740|"~     Technological advances and non-invasive techniques to modulate brain function have been~     developed, including transcranial Direct Current Stimulation (tDCS). Basically, electrodes~     are placed on the brain regions to stimulate or inhibit it. Subsequently, a continuous~     electrical current (0.4-2 mA) is imposed, for a period of 3-20 minutes, to modify cortical~     excitability. Few are the research groups that work on the topic of primary dysmenorrhea and~     the use of tDCS as the focus of study. Preliminary studies associated the use of tDCS with~     pain reduction, but the outcomes of physical and behavioral function needs further~     investigation.~   "
29205|NCT03184727|"~     The pulmonary vasculopathy and right heart dysfunction in COPD are drawing increasing~     attention these days. Recent researches show that pulmonary vasculopathy and right heart~     dysfunction relate to greater severity in COPD. Applying appropriate modalities for early~     detection of pulmonary vasculopathy and right heart dysfunction is of great importance.~     What's more, the interaction mechanism between pulmonary vasculature, right heart and COPD~     still needs to be further studied. The aim of our study is to develop an assessment system of~     pulmonary vasculopathy and right heart dysfunction in COPD patients and elucidate their~     impact on COPD course and outcome.~   "
29206|NCT03184714|"~     Chronic obstructive pulmonary diseases (COPD) coexisting with obstructive sleep apnea is~     called overlap syndrome (OS). Patients with OS seem to have worse prognosis than patients~     with only one disorder. Noninvasive positive pressure ventilation is an efficient treatment~     in obstructive sleep apnea, but the effectiveness in improving outcomes of OS patients is~     still not fully investigated. The aim of this non-randomized concurrent control trial is to~     evaluate noninvasive positive pressure ventilation's effectiveness in OS patients.~   "
29208|NCT03184688|"~     Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with~     involving compression of the median nerve in the carpal tunnel. Although many conservative~     managements of CTS, the effectiveness of these methods is insignificant or only persist for a~     short duration. The platelet rich plasma (PRP) is a new and potential treatment for patients~     with kinds of musculoskeletal disorders and recent reports showed being beneficial for~     peripheral neuropathy in animal studies. Since 2014, four small clinical trials showed the~     positive effect of PRP in peripheral neuropathy. Among these studies, two small trials showed~     beneficial effect of PRP for patients with mild CTS. However, the definite clinical effect of~     PRP for peripheral neuropathy from currently published studies is unclarified because these~     studies enrolled a few patients and lacked long-term follow-up (no more than 6 months~     follow-up).~   "
29209|NCT03184675|"~     This study aimed to examine the effects of functional action observation training on gait~     ability in chronic stroke patients.~   "
29210|NCT03184662|"~     Type 2 diabetes is a chronic condition whose prevalence is increasing globally. Kidney~     disease is a key complication of diabetes and is among the most common cause of end-stage~     renal disease, requiring renal replacement therapy.~      It has been shown that the trajectory of renal function (estimated glomerular filtration rate~     - eGFR) is of great prognostic value for renal and cardiovascular endpoints in diabetic~     patients. However the clinical use of this prognostic marker is not associated to date with a~     clear therapeutic intervention, effective in patients with type 2 diabetes identified with~     this biomarker.~      In France, type 2 diabetes patients have twice less physical activity than non-diabetic~     persons. Recently, it has been published that physical activity was associated with an~     improvement of renal risk in patients with type 2 diabetes, recruited from the LOOK-AHEAD~     study. It was demonstrated that high-intensity physical activity (HIPA) can have several~     additional advantages over moderate-intensity, on blood pressure improvement, and~     cardiovascular risk profile modification. In addition, this procedure was shown to be safe in~     patients with high cardiovascular risk.~      We plan to perform a randomized intervention comparing a structured program of high-intensity~     physical activity (HIPA) vs standard recommendations for physical activity on renal function~     decline (primary outcome) and mortality, renal and cardiovascular endpoints, patients' safety~     and quality of life (secondary outcomes). Study participants will be patients with~     established type 2 diabetes and a high renal risk, identified by rapid renal function~     decline, defined as a eGFR slope below -5ml/min per 1.73 m2/yr. The intervention is planned~     to last for 2 years.~   "
29211|NCT03184649|"~     The Effect of Ibuprofen, Paracetamol versus Placebo on Pain during Local Anesthetic Injection~     and Following Dental Extraction in Primary Molars: A Randomized clinical trial~   "
29212|NCT03184636|"~     Rationale:~      To identify the prevalence of Acute-on-chronic liver failure in Zagazig University Hospitals.~      The question of the research:~      How much the prevalence of Acute-on-chronic Liver Failure in Zagazig University Hospitals?~      The aim of the work:~      The aim of the study is to identify the presence of Acute-on-chronic Liver Failure in Zagazig~     University Hospitals~      Objectives:~      To estimate the prevalence of Acute-on-chronic Liver Failure in Zagazig University Hospitals.~      Subjects and Methods:~      I . Technical Design:~        -  Site of the study: Gastroenterology and Hepatology Unit- Zagazig University Hospitals~        -  Sample size: ''all patients admitted to Gastroenterology and Hepatology Unit with the~          criteria of ACLF according to EASL-AASLD from June 2017 to December 2017 were included~          in this study''.~      II . OPERATIONAL DESIGN:~        -  Type of the study: a prospective study.~        -  Full medical history - taking.~        -  Full clinical examination.~        -  Laboratory investigations including Routine laboratory investigation  CBC, Liver~          functions test, kidney functions test and prothrombin time ~      III. Administrative Design:~        -  Approvals obtained for performing the study from the official or governmental~          department.~        -  An ethical committee from the faculty of medicine and patients included in the study.~      Results:~      Collected data will be presented in tables and suitable graphs and analyzed according to~     standard statistical methods~   "
29213|NCT03184623|"~     ICUacquired weakness is a common complication of critical illness, particularly in patients~     receiving mechanical ventilation and/or suffering from conditions leading to the systemic~     inflammatory response syndrome.~   "
29214|NCT03184610|"~     The OCT used in this trial offers the advantage of both a non-contact method and a very high~     axial resolution. Determined parameters with the highest potential of diagnostic~     discrimination between eyes with Keratoconus and healthy eyes are investigated. Aim of this~     trial is to investigate differences of specific parameters of epithelium thickness maps at~     healthy eyes and eyes with Keratoconus.~   "
29215|NCT03184597|"~     Cutaneous adverse drug reactions (cADRs) include mild maculopapular exanthema (MPE) and~     severe cutaneous reactions such as hypersensitivity syndrome, Stevens-Johnson syndrome (SJS),~     and toxic epidermal necrolysis (TEN). cADRs are considered as a major public health issue~     because of their potentially life-threatening morbidity, especially severe cutaneous~     reactions. The incidence of SJS/TEN is estimated to vary from 1 in 1,000 to 10,000 drug~     exposures, and its mortality is as high as 35%. Antiepileptic drugs (AEDs), particularly~     those with aromatic ring structures such as carbamazepine (CBZ), oxcarbazepine (OXC),~     lamotrigine (LTG), phenobarbital (PB), and phenytoin (PHT), are among the most common causes~     of severe cutaneous reactions. The incidence of AED-induced SJS was estimated as 0.2% and all~     cases occurred in individuals receiving aromatic AEDs.~      Previous studies have validated that the human leukocyte antigen (HLA) allele HLA-B*15:02 is~     strongly associated with CBZ-induced SJS/TEN in southern Han Chinese and populations in~     southeast Asia. Our recent studies indicated that HLA-A*24:02 is a common genetic risk factor~     for CBZ-, LTG-, and PHT-induced SJS/TEN. It is also associated with MPE. Additionally,~     another four alleles, including HLA-B*15:01, HLA-B*15:11, HLA-A*02:01,and HLA-DRB1*01:01,~     were showed to be potential risk factors for aromatic AEDs-induced SJS/TEN. In 2007, the US~     Food and Drug Administration issued the safety alert that recommended HLA-B*15:02 screening~     for people with Asian ancestry before starting CBZ, and avoidance of the drug if the test is~     positive. Subsequent studies from Taiwan, Hong Kong and Thailand demonstrated that~     HLA-B*15:02 screening before commencing CBZ can significantly reduce the incidence of~     CBZ-induced SJS/TEN. However, the overall incidence of AEDs-induced SJS/TEN remained~     unchanged in Hong Kong, as PHT-induced SJS/TEN increased when CBZ-SJS/TEN decreased.~     Moreover, no study focuses on the incidences of AEDs-induced cADRs with and without HLA~     screening before commencing aromatic AEDs. Therefore, we are planning to conduct a~     multicenter prospective study to examine the reduction of AEDs-induced cADRs after the HLA~     screening prior to the beginning of aromatic AEDs administration.~   "
29216|NCT03184584|"~     Phase 2, open-label, single-arm, multi-centre study evaluating the long term safety and~     tolerability of PBI-4050 in subjects with Alström Syndrome who have completed a preceding~     ProMetic-sponsored Alström Syndrome study with PBI-4050.~   "
39399|NCT03050983|"~     Single site prospective observational nested study of bedside CS20p monitor on the GCF~     impeded into a retrospective review of the frequency of escalation of care with intermittent~     vitals signs compared to continuous respiratory monitoring.~   "
29218|NCT03184558|"~     This is an open label, single arm, multi-centre phase II study to assess the anti-tumour~     activity and safety of bemcentinib (BGB324) in combination with pembrolizumab in up to 56~     patients with previously treated, locally advanced and unresectable, or metastatic TNBC or~     TN-IBC. The study will utilise an extension of Simon's 2-stage design. The primary objective~     is objective response rate.~   "
29219|NCT03184545|"~     The purpose of study is to evaluate the efficacy of the electrical muscle stimulation (EMS)~     device in patients with patellofemoral pain known as anterior knee pain. Usual treatment for~     it is physical therapy (PT). We want to evaluate and see if adding the electrical muscle~     stimulation will fasten the recovery and improved outcome in patellofemoral pain syndrome.~     Half of participants will receive EMS and PT while other half will receive PT only.~   "
29220|NCT03184532|"~     To reduce the risk of perioperative pulmonary aspiration of gastric contents, oral intake of~     liquids or solids is not allowed for certain periods. Recently, the ultrasound (US) is used~     to evaluate the volume and the nature of the stomach content. In its latest recommendations,~     the American Society of Anesthesiologists (ASA) shortened the duration preoperative fasting.~     The aim of the study is to evaluate the efficacy of ASA recommendations in diabetic patients~     using ultrasound (US) scanning of the stomach (antrum).~   "
29221|NCT03184519|"~     Proof of concept study for the prediction of ongoing pregnancy in women undergoing In-Vitro~     Fertilization (IVF), using hyperglycosylated human chorionic gonadotropin (hhCG), early after~     In-Vitro Fertilization and fresh Embryo Transfer (IVF-ET).~   "
29222|NCT03184506|"~     Inadvertent perioperative hypothermia is an unintentional drop in core body temperature below~     36°C. Intraoperative hypothermia can lead to serious clinical complications such as,~     myocardial ischemia, coagulopathy, immunosuppression, and surgical wound infection.~     Hypothermia develops easily during surgeries that require irrigation fluid, such as~     laparoscopic surgery and transurethral resection of the prostate. Although isothermic~     irrigation fluid was suggested to prevent perioperative hypothermia, it can be difficult to~     warm a large volume of irrigation fluid.~      Re-distribution after induction of anesthesia is the most important cause of perioperative~     hypothermia. The extent of re-distribution is proportional to the gradient between the core~     and peripheral compartments. Pre-warming increases the heat content of the peripheral thermal~     compartment, reducing the gradient for redistribution. Recently, A recent-meta analysis~     suggested that as a single strategy, preoperative forced air warming had significant benefits~     than other warming methods. Also, it was reported that only 20 (or even 10) min of~     pre-warming mostly prevented patients from perioperative hypothermia under general~     anesthesia. However, few studies have examined whether short time pre-warming can reduce~     hypothermia due to a large amount of irrigation fluid during surgery under spinal anesthesia.~      The purpose of this study is to assess whether the application of preoperative forced air~     warming set to high temperature (> 43°C) for brief period can prevent hypothermia or~     shivering during procedures requiring large volumes of cold irrigation.~   "
29223|NCT03184493|"~     This prospective trial aims to compare the role of celebrex alone, metformin alone, and~     celebrex plus metformin in preventing HCC recurrence after hepatic resection.~   "
29224|NCT03184480|"~     The aim of this post-marketing investigation is to collect and assess the information about~     safety and effectiveness of ARNUITY® ELLIPTA® (hereinafter referred to as Arnuity) in daily~     clinical practice. The investigation will include subjects with a diagnosis of asthma~     bronchial who are naïve to ARNUITY. The investigator will monitor the information about~     safety and effectiveness of ARNUITY for one year from the start date of ARNUITY~     administration and Pneumonia will be considered as the priority investigation matter. 300~     subjects, from approximately 150 medical institutions, will be included in this analysis.~     ARNUITY ELLIPTA is the registered trademark of GlaxoSmithKline (GSK) group of companies.~   "
29225|NCT03184467|"~     This clinical study is designed as a multi-center, randomized, double-blind,~     placebo-controlled, parallel design, prospective, phase II clinical trial.~      An eligible subject who meets inclusion and exclusion criteria is randomly assigned to three~     groups: study group 1 (GV1001 0.56 mg), study group 2 (GV1001 1.12 mg) or placebo group. A~     randomized subject is administered either GV1001 or placebo in a total of 14 times and will~     be evaluated for the efficacy and safety at week of 24.~   "
29226|NCT03184454|"~     This study involves the use of the Medtronic PC+S deep brain stimulation for the treatment of~     intractable OCD.~   "
29227|NCT03184441|"~     This pilot project proposes to develop and test a new device to manage (defined as resolving,~     prohibiting, inhibiting or preventing) the development of Deformational Plagiocephaly (DP) in~     prematurely born infants weighing < 1 kilogram.~   "
29228|NCT03184428|"~     This study collects intra- and postoperative data from the patients´charts retrospectively~     and evaluates retro- and prospectively the rate of posterior capsule opacification (PCO)~     following implantation of the intraocular lens L 313.~   "
29229|NCT03184415|"~     THe purpose of this study is to evaludate the Efficacy and Safety of DWC20155/DWC20156~     Combination Therapy in Patients with Gastritis~   "
29230|NCT03184402|"~     The purpose of this study is to evaluate the Efficacy and Safety of DWJ1252 in treatment of~     Functional Dyspepsia.~   "
29231|NCT03184389|"~     The aim of this research is to build systems that can recognize when people are stressed and~     then provide them with relaxation prompts in the moment to reduce their likelihood of being~     stressed, smoking, or overeating in the near future. Using these systems should help smokers~     be more effective in their attempts to quit by reducing their tendency to lapse when they are~     stressed or experiencing other negative moods or behaviors.~   "
29232|NCT03184376|"~     This trial will investigate the therapeutic potential of a prebiotic supplement to improve~     histological parameters of NASH. In a single-blind, placebo controlled, randomized pilot~     trial will be conduced in individuals with liver biopsy confirmed NASH (Non-alcoholic fatty~     liver activity score (NAS) ≥ 5). Participants will be randomized to receive oligofructose (8~     g/day for 12 weeks and 16g/day for 24 weeks) or isocaloric placebo for 9 months. The primary~     outcome measure is the change in liver biopsy NAS score and the secondary outcomes include~     changes in body weight, body composition, glucose tolerance, serum lipids, inflammatory~     markers, and gut microbiota.~   "
29233|NCT03184363|"~     The purpose of this study is to explore the Efficacy and Safety of DWP450 for treating Crows~     Feet Lines(CFL) in combination with glabellar line(GL) as extension study of phase 3 study~     for CFL.~   "
29234|NCT03184350|"~     The APROVE study is a prospective single-center single-arm phase-II study. Patients with~     cervical or endometrial cancer after surgical resection who have an indication for~     postoperative pelvic radiotherapy will be treated with proton therapy instead of the commonly~     used photon radiation. A total of 25 patients will be included in this trial. Patients will~     receive a dose of 45-50.4 Gray in 1.8 Gray fractions 5-6 times per week using active~     raster-scanning pencil beam proton radiation. Platinum-based chemotherapy can be administered~     if indicated. The primary endpoint of the study is the evaluation of safety and treatment~     tolerability of pelvic radiation using protons defined as the lack of any CTC AE Grade 3 or 4~     toxicity. Secondary endpoints are clinical symptoms and toxicity, quality of life and~     progression-free survival. The aim is to explore the potential of proton therapy as a new~     method for adjuvant pelvic radiotherapy to decrease the dose to the bowel, rectum and bladder~     thus reducing acute and chronic toxicity and improving quality of life.~   "
29235|NCT03184337|"~     This pilot study aims to determine whether adding a sleep extension and sleep hygiene~     intervention to an existing lifestyle improvement program improves its efficacy for weight~     loss in those at risk for diabetes and cardiovascular disease. Half of the participants will~     receive the Centers for Disease Control's standard PreventT2 program and half of the~     participants will receive the same program with an additional sleep intervention.~   "
29236|NCT03184324|"~     The purpose of this study is to determine the efficacy and safety of DWP14012 compared to~     esomeprazole in the treatment of erosive gastroesophageal reflux disease classified as Los~     Angeles(LA) classification grades A to D.~   "
29237|NCT03184311|"~     This study investigates the effects of a 12-week high-intensity interval training (HIT) on~     exercise tolerance, functional status and quality of life in patients with chronic heart~     failure with preserved ejection fraction (HFpEF), in comparison to a control group continuing~     to undergo usual care.~   "
29238|NCT03184298|"~     The proposed project will provide data concerning dating and sexual interactions that occur~     on Fort Bragg, North Carolina. The investigators will be able to use data from this research~     to develop a program that promotes health in men's sexual and dating relationships and~     address the role of alcohol in sex and dating in subsequent research studies. The long term~     goal of this research is to reduce rates of sexual assault in the military by providing a~     sexual assault prevention program tailored to at risk male Soldiers that can be disseminated~     across military posts.~   "
29239|NCT03184285|"~     Comparability of discontinuous non-invasive (sphygomanometric) and continuous semi-invasive~     and invasive (Masimo© ; Nexfin© Monitoring ; FloTrac© Edwards Lifesciences) beat to beat~     measurement methods for the determination of arterial blood pressure in patients undergoing~     bariatric surgery.~   "
29240|NCT03184272|"~     Comparability of discontinuous non-invasive (sphygomanometric) and continuous semi-invasive~     and invasive (Masimo©; Nexfin© Monitoring ; FloTrac © Edwards Lifesciences) beat to beat~     measurement methods for the determination of cardiac output and fluid responsiveness in~     patients undergoing bariatric surgery.~   "
29241|NCT03184259|"~     A new lower-limb training system is introduced to enhance the clinical service for~     post-stroke lower limb rehabilitation and to assist the establishment of public clinical~     trial in different settings and share experiences on the robot-assisted functional training.~   "
29242|NCT03184246|"~     The investigators suppose that direct laryngoscopy is connected with deeper insertion of~     endotracheal tube in comparison to videolaryngoscopy. Correction of this malposition can~     cause postoperative discomfort and further complications in some patients.Routine use of~     videolaryngoscopy could minimize these problems.~   "
29243|NCT03184233|"~     Rapid ventricular pacing (RVP) is a technique to obtain flow arrest for short periods of time~     during dissection or rupture of the aneurysm. RVP results in an adequate fall in blood~     pressure which presents as an on-off phenomenon. However it is not clear whether repetitive~     periods of pacing are harmless for the patient. Silent cardiac and cerebral infarcts may be~     undetected. The investigators will study the safety of RVP, particularly for the heart and~     the brain.~   "
29244|NCT03184220|"~     This study aimed to investigate the effects of myofascial release therapy (MRT) for improving~     pressure pain thresholds (PPTs), range of motion and pain in patients with mechanical neck~     pain (NP).~   "
29245|NCT03184207|"~     In the operating room, most intubation procedures (IP) are scheduled and performed on~     hemodynamiccaly stable patients. In the ICU, IP is frequently performed in emergent patients,~     because of unstable hemodynamics and/or acute respiratory failure, and complicated by a~     subsequent cardiovascular collapse. Transthoracic echocardiography (TTE) has become readily~     available in most ICUs for several years. Echocardiography enables to perform a noninvasive~     hemodynamic evaluation (cardiac function and volemia status).~      We hypothesized that performing a TTE prior to IP may help to predict cardiovascular collapse~     and its components.~   "
29246|NCT03184194|"~     Evaluation of the effect of nivolumab and daratumumab with or without low-dose~     cyclophosphamide in patients with relapsed/refractory multiple myeloma.~   "
29247|NCT03184181|"~     The supraspinatus muscle tendinopathy show a big impact, however, there is a lack of~     awareness about the options of the physiotherapist treatment. It is necessary to do studies~     about effectiveness of therapeutic percutaneous electrolysis (EPTE®). This technique enables~     treatment of the tendinopathies and the broken muscle fibrilare. It is base on the~     application of galvanic current through a acupuncture needle. To analyze the effectiveness of~     therapeutic percutaneous electrolysis (EPTE®) in the treatment of supraspinatus muscle~     tendinopathy. Single center randomized controlled trial, parallel treatment design. A~     specialist physician will be diagnosed the supraspinatus muscle tendinopathy. Participants~     will be randomly assigned to receive treatmen for 4 weeks: EPTE® associated with eccentric~     exercises or dry needling with the same eccentric exercises. Both interventions were~     performed under ultrasound guidance with a portable ultrasound (General Electric LogicE).~     Data will be collected by a blinded evaluator.~   "
29258|NCT03184038|"~     This phase II trial studies the neurological function in patients with multiple brain~     metastases undergoing stereotactic radiosurgery (SRS) or stereotactic body radiation therapy~     (SBRT). Assessment of neurocognitive function may help show that SRS preserves neurological~     function in patients with multiple brain metastases better than SBRT~   "
29248|NCT03184168|"~     This open-label, radiolabeled, single 100-mg dose study in 6 healthy male volunteers has been~     designed to further the understanding of human metabolism of lorlatinib. A prior radiolabel~     study using [14C]lorlatinib (study B7461004) identified an unexpected major metabolite in~     plasma; a benzoic acid metabolite (M8) resulting from cleavage of the amide and aromatic~     ether bonds of lorlatinib, accounting for 21.0% of the circulating radioactivity. However,~     due to the position of the 14C radiolabel on the carbonyl carbon, the metabolic fate of the~     larger fragment of lorlatinib resulting from this cleavage, the pyrido-pyrazole substructure,~     could not be determined. In this current study, the radiolabel will be on the pyrazole ring~     allowing for monitoring the metabolic fate of the pyrido-pyrazole part of the lorlatinib~     molecule cleaved during the formation of the M8 metabolite. Since M8 will not be~     radiolabeled, its concentrations in plasma will be determined using a validated assay.~      The sample size of 6 was selected to ensure at least 4 fully evaluable subjects with~     completed collections of plasma, urine, and fecal samples. This is a standard sample size~     used for mass-balance/ADME studies which include assessment of metabolic profiling, and is~     not based on empirical data or hypothesis testing criteria.~      Metabolic profiling of radiolabeled components will be performed on pooled plasma samples as~     well as on cumulative urine and feces excreted until Day 14 postdose or until one of the~     following early release criteria is met: 1) recovery in excreta of at least 90% of~     administered radioactivity, or 2) less than 1% of administered radioactivity being recovered~     in excreta from two consecutive days (ie, total for urine + feces should be <1% on 2~     consecutive days). Plasma concentrations of both lorlatinib and its unlabeled M8 metabolite~     will be analyzed using validated assays. Information from this study will complement the~     metabolic profiling results from study B7461004, will help guide in the assessment of~     potential drug-drug interactions (DDIs) and the need for other DDI studies with lorlatinib.~      Banked biospecimens will be collected for the purpose of conducting research. Collecting~     biospecimens for exploratory analyses makes it possible to better understand the~     investigational product's mechanism of action and to seek explanations for differences in,~     for example, exposure, tolerability, safety, and/or efficacy not anticipated prior to the~     beginning of the study.~   "
29249|NCT03184155|"~     This is a single-center double blind, placebo controlled study of patients undergoing a~     cardiac catheterization where the need for a percutaneous coronary intervention (PCI) is~     anticipated or will be determined during the early diagnostic phase. The study will assess~     the use of intracoronary nicardipine vs. sterile saline injection in reducing the index~     measurement of microcirculatory resistance (IMR). Fifty consecutive patients presenting to~     the Thomas Jefferson University (TJUH) Cardiac Catheterization lab will be randomized in a~     1:1 fashion to receive either intracoronary nicardipine or sterile saline injection prior to~     PCI. IMR values will be assessed pre and post procedure. Data on clinical outcomes and~     adverse events will be collected by phone at 30 days and 1 year following the procedure.~   "
29250|NCT03184142|"~     Intimidation of medical students by health care professionals is a well-documented~     phenomenon. Raising awareness of what constitutes intimidation is a preferred method for~     preventing it through increased reporting. Simulation is a novel method of raising awareness~     of intimidation.~      This is a randomised controlled trial comparing the effectiveness of simulation (involving~     actors), an educational video and no intervention, as adjuncts to group discussion, on~     students' ability to identify and report intimidation. Medical students from the University~     of Montreal in Montreal, Canada, will be recruited at the beginning of surgical clerkship.~     They will complete a standardized and validated pre-intervention questionnaire on their~     experience with intimidation consisting of multiple choice questions and short answers. They~     will be randomised to one of the three interventions lasting 70 minutes that will be followed~     by a 20-minute standardized discussion on intimidation with all students participating~     together. At the end of their surgical rotation, they will complete a similar~     post-intervention questionnaire with additional questions pertaining to the reporting of~     intimidation.~      Differences in intimidation reporting after the intervention as well as a before and after~     comparison of the Negative Acts Questionnaire score will be studied.~   "
29251|NCT03184129|"~     To verify and assess the safety and efficacy of newly developed knee prosthesis (Wuhan~     Yijiabao Biomaterial Co., Ltd.) in total knee arthroplasty.~   "
29252|NCT03184116|"~     This project will implement and evaluate a community-based intervention to improve individual~     outcomes in violence-related injuries and homicide. Young African American men participating~     in a focused deterrence program (the Birmingham Violence Reduction Initiative, BVRI) will be~     randomized to receive an additional individual intervention based on the cognitive-behavioral~     Reasoning and Rehabilitation program.~   "
29253|NCT03184103|"~     Acute post streptococcal glomerulonephritis is an immunologic response of the kidney to~     infection, characterized by the sudden appearance of edema, hematuria, proteinuria and~     hypertension . It is essentially a disease of childhood that accounts for approximately 90%~     of renal disorders in children. The disease occurs especially in children between the ages of~     2 and 12 years and young adults, and more often in male than in female .~   "
29254|NCT03184090|"~     This is an international, open-label, non-controlled, multicenter phase II clinical trial~     with two different primary objectives: a biological and a clinical objective.~      From a clinical point of view, the objective is to assess the clinical benefit of the~     combination of palbociclib and hormonotherapy in patients with advance breast cancer that had~     previously received endocrine therapy in combination with palbociclib and had achieved~     clinical benefit during palbociclib treatment with subsequent disease progression.~      From a biological point of view, the challenge is to define a molecular profile that allow~     identifying patients that could benefit more from continuing on palbociclib after progression~     on a prior palbociclib-containing regimen~   "
29255|NCT03184077|"~     To evaluate the rates of dyspareunia with rapidly absorbing polyglactin 910 compared to~     monocryl using a validated sexual function questionnaire.~      To assess maternal satisfaction with the laceration repair and suture material.~      To assess overall perineal pain using a visual analog scale.~      To assess the rate of wound breakdown and the need for suture removal.~   "
29256|NCT03184064|"~     Large postprandial glucose responses are associated with increased risk of chronic diseases,~     including diabetes and cardiovascular disease. Our group have previously shown that fruit~     polyphenol extracts, when consumed immediately before a mixed carbohydrate meal, reduce~     postprandial glycaemia. The aim of this study is to investigate the effects of a blackcurrant~     polyphenol extract and citrus polyphenol extract (and their combination), on postprandial~     glycaemia, insulinaemia and gastrointestinal hormone concentrations following a mixed~     carbohydrate test meal. It is hypothesised that blackcurrant and citrus extracts alone will~     inhibit glycaemia compared to placebo, and a combination of the two will have a greater~     effect.~   "
29257|NCT03184051|"~     This study investigates the potential of the ultrasound imaging technique to diagnose the~     severity of knee osteoarthritis (OA). In parallel, measurements will also be conducted using~     Magnetic Resonance Imaging (MRI) and histology analysis as reference tools.~   "
29289|NCT03183635|"~     Stroke survivors have higher risks of falling compared to other healthy non-stroke adults.~     Stroke patients' balance can be trained by Kinect-based training that enable user friendly~     and interactive training.~   "
29259|NCT03184025|"~     The aim was to evaluate the clinical performance of HEMA-containing and HEMA-free all-in-one~     self-etch adhesives with and without a surface sealing process with a nanohybrid composite in~     occlusal caries restorations. The hypothesis is that the HEMA-containing and HEMA-free~     all-in-one self-etch adhesive and the surface sealing process would significantly effect~     clinical performance of occlusal restorations.~   "
29260|NCT03184012|"~     The hypothesis to be investigated is that no difference will be found upon comparing resin~     composite strip crowns and NuSmile zirconia crowns (NuSmile ZR) esthetic primary anterior in~     restoring anterior primary teeth.~   "
29261|NCT03183999|"~     This randomized, double-blind, placebo-controlled study aimed to evaluate the effect of~     ginseng(GINST) supplementation for 12 weeks on sperm motility.~   "
29262|NCT03183986|"~     Treatment of neonatal jaundice is phototherapy with blue light at wavelength about 460 nm and~     irradiance > 30 uw/cm2/nm. Though, recent in vitro models have suggested that a wavelength of~     478 nm should be optimal in reducing total serum bilirubin. The aim of this study is~     therefore to compare the efficiency of phototherapy with light emitting diodes (LED's) of 478~     vs. 459 nm., respectively.~   "
29263|NCT03183973|"~     Sternal wound and there complication such as infection, Bruising and scar formation are known~     as major complication cardiac surgery with a high mortality rate up to 50%. Several~     approaches have been proposed for treatment of chronic sternal wounds in these patients.~     however, Underlying confounding factors such as old ages,diabetes mellitus, systemic hypoxia,~     atherosclerosis and malnutrition have main role against wound repairing. In this study~     investigators aimed to treatment of patients with open heart surgery and need to strict~     monitoring of sternal wound repair by Platelet Rich Fibrin.~   "
29264|NCT03183960|"~     Since august 2016, the researchers at a highly specialized neurorehabilitation hospital in a~     Danish region with 1.2 inhabitants have in cooperation with health professionals from a~     specialized neurorehabilitation in a Danish municipality with 336,000 inhabitants, worked~     through and is still working with an iterative process in the development of a novel~     self-management support intervention for elderly stroke individuals.The intervention is going~     to be implemented into the second phase- a randomized clinical controlled trial (RCT) in the~     project named 'Stroke - 65 plus. Continued active life'.~   "
29265|NCT03183947|"~     The aim of the study is the examination of brain plasticity on on affective symptoms after~     neuromodulation with fMRI (functional magnetic resonance imaging) neurofeedback. During the~     fMRI neurofeedback training, patients with depression as well as patients with schizophrenia~     are trained to consciously regulate the activity of areas which are associated with the~     cognitive reappraisal of emotional stimuli.The aim is to improve the patients' subjective~     emotional processing and perception in everyday life as well as to investigate the impact of~     neurofeedback on resting-state networks in the brain. Healthy participants will be~     investigated as control group.~   "
29266|NCT03183934|"~     This is an open-label follow up study to evaluate the safety for the subjects with~     ALLO-ASC-DFU treatment in phase 1/2 clinical trial(ALLO-ASC-EB-101) for 24 months.~   "
29267|NCT03183921|"~     This is a multicentre, multinational, prospective observational investigation on ICU~     critically ill patients affected by nosocomial pneumonia, defined as: Out of ICU~     Hospital-acquired Pneumonia (HAP), Non-ventilator ICU-acquired Pneumonia (NV ICUAP),~     Ventilator associated pneumonia (VAP) Ventilator associated tracheobronchitis (VAT).~   "
29268|NCT03183908|"~     The overall aim of the study is to compare safety and immunogenicity of adjuvanted~     inactivated influenza vaccine (IIV) (FLUAD) versus High-Dose inactivated influenza (Fluzone~     High Dose) vaccine in ≥65 years (20% aged ≥80 years). A prospective, randomized, blinded~     clinical trial that will be conducted during the 2017/2018 and 2018/2019 influenza seasons.~     During each season, approximately 220 older adults will be enrolled at Duke University~     Medical Center and 140 older adults at Boston University Medical Center. Eligible subjects~     will be randomized to receive either adjuvanted influenza vaccine or High-Dose influenza~     vaccine. All subjects will receive vaccine and provide a blood draw at Visit 1, and then~     return for a second blood draw without vaccination about 4 weeks later to assess for~     influenza antibody titers. A subset of 100 subjects at Duke will provide a third blood draw 6~     months post-vaccination to assess for waning of influenza antibody titers. Subjects will~     record the occurrence of local and systemic reactions (including fever, pain, tenderness,~     swelling, redness, general systemic systems), unsolicited adverse events, medical care~     utilization, and changes in medications over 8 days following vaccination. In addition,~     serious adverse events and events of clinical interest will be assessed through 42 days~     post-vaccination. Quality of life will be assessed 8 days post-vaccination and vaccine~     perceptions surveys will be administered 8 days and 4 weeks post-vaccination.~   "
29269|NCT03183895|"~     This is an international multi-center, non-randomized, prospective safety and performance~     study to AccuCinch® Ventricular Repair System in patients with Functional Mitral~     Regurgitation Due to Dilated Ischemic or Non-Ischemic Cardiomyopathy~   "
29270|NCT03183882|"~     We aim to determine if descriptive normative feedback of peer prescribing reduces opioid~     analgesic prescribing by emergency medicine providers~   "
29271|NCT03183869|"~     The proposed randomized, open label, with treat as usual control group (standard treatment or~     any disease modifying drugs), crossover phase II study will be conducted in 40 patients (n=20~     per group) with the relapsing forms of multiple sclerosis according to the McDonald 2010~     Criteria.~      Patients will be randomized into 2 intervention groups. One will receive the FMT from month 1~     and for the first 6 months (early intervention group). On the other hand, the other group~     will be a control group during the first 6 months and will receive the FMT for the last 6~     months of the study. Patients will be screened for eligibility based on MS diagnosis and EDSS~     and if eligible then consented. All qualified patients will not be currently or recently~     treated with high dose steroids.~   "
29272|NCT03183856|"~     The aim of this study is to determine the clinical efficacy and feasability of gait~     rehabilitation robot through approving functional improvement by an end-effector typed gait~     robot in patients underwent total knee arthroplasty.~   "
29273|NCT03183843|"~     The efficacy and safety of anticoagulation therapy using dabigatran in comparison with~     warfarin will be evaluated in patients with atrial fibrillation after mitral valve prosthetic~     replacement concomitant with Cox-Maze procedure.~   "
29274|NCT03183830|"~     This study evaluates the potential anti-inflammatory effects of inorganic dietary nitrate in~     a model of acute inflammation relevant to cardiovascular disease (CVD).~      Green leafy vegetables contain large amounts of inorganic nitrate, and research suggests that~     this nitrate has beneficial effects on the heart and blood vessels. We have shown~     anti-inflammatory benefits of inorganic nitrate in pre-clinical models of CVD, early~     mechanistic studies in healthy volunteers, and in patients with hypertension,~     hypercholesterolaemia and those suffering acute heart attacks that translate to~     cardiovascular benefits. Understanding the mechanism of how this is achieved may open new~     therapeutic options in CVD.~      We therefore wish to explore whether inorganic nitrate might alter inflammatory responses~     using a blister-model of acute skin inflammation. This study is a randomised control trial~     with parallel limbs where half of patients receive nitrate-rich beetroot juice, and the other~     half a nitrate-deplete placebo beetroot juice.~   "
29275|NCT03183817|"~     The goal of the research project PROTECT is to translate the Person-Centred Care (PCC)~     principles into an eHealth (the use of information and communication technologies for health)~     context. A developed PCC eHealth platform will be used as a tool to identify patients´~     resources to enhance coping and living with their chronic illness by means of a dialog and~     partnership with staff and relatives. The PCC eHealth platform will not replace, but instead~     be used as add on treatment to usual care (guideline directed care).~   "
29276|NCT03183804|"~     This is an open-label follow up study to evaluate the safety for the subjects with~     ALLO-ASC-DFU treatment in phase 2 clinical trial (ALLO-ASC-DFU-201) for 23 months.~   "
29277|NCT03183791|"~     The goal of this research is to assess the utility of smartphone-based progressive muscle~     relaxation (PMR) for the treatment of headaches. While there are many commercially available~     electronic diary and mind-body intervention apps for headache, there is little data showing~     their efficacy. RELAXaHEAD app incorporates the electronic PMR that was successfully used in~     an earlier epilepsy study and beta tested with headache specialist and migraine patient~     input. It also has functionality to track medications. This 2-arm randomized controlled study~     will evaluate the feasibility and acceptability of RELAX for use with headache patients. One~     arm will be the RELAX group (the RELAXaHEAD app) and the other arm will be a monitored usual~     care (MUC) group (this group receives standard of care and uses the electronic daily symptom~     reporting diary). The goals are to assess the feasibility and adherence of the RELAX~     intervention in persons with headache (Aim 1) and to gather data on the effects of the RELAX~     intervention on headache disability (Aim 2).~   "
29278|NCT03183778|"~     The purpose of this proof-of-concept controlled-feeding study is to determine whether~     patiromer (Veltassa®, Relypsa, Inc., Redwood City, CA) can be used to maintain normal serum~     potassium concentrations in chronic kidney disease (CKD) patients who are transitioned to a~     plant-rich diet.~   "
29279|NCT03183765|"~     Warts are benign epidermal tumors caused by human papilloma virus, which are epitheliotropic~     non-enveloped double stranded DNA viruses. Transmission of warts occurs from direct~     person-to-person contact or indirectly by fomites . Warts appear in various forms including~     verruca vulgaris, plane, plantar, filiform, digitate and periungual.~   "
29280|NCT03183752|"~     It has been shown that insulin might be involved in the pathogenesis of thyroid growth.~      Objective To evaluate the impact of IR and metformin use on the volume of benign thyroid~     nodules (TNs).~      Methods A randomized clinical trial to placebo (P) or MTF use. Previous fine needle~     aspiration confirming the diagnosis is necessary to inclusion. Patients will receive similar~     tablets of MTF and placebo and instruct to take 3 tablets/day of MTF (500mg/tablet). Thyroid~     volume, as TN volume, will be assess by ultrasound, both in the beginning, six months and one~     year after randomization, by the same researcher blinded regarding location group. Blood~     samples to measure: TSH, FT4, TPO-Ab, lipid profile, glucose and insulin were done after 8h~     fasting.~   "
29281|NCT03183739|"~     The purpose of this study is to evaluate the safety and tolerability and evaluate~     pharmacokinetics of single and multiple ascending oral doses of ASP8062 in nonelderly~     Japanese male and female subjects.~   "
29282|NCT03183726|"~     This is an open-label follow up study to evaluate the safety for the subjects with~     ALLO-ASC-DFU treatment in phase 1 clinical trial (ALLO-ASC-DFU-101) for 23 months.~   "
29283|NCT03183713|"~     This is a single-center prospective randomized investigation of patients undergoing surgical~     arthrodesis for single or multi-level cervical disease, resulting in cervical radiculopathy.~     Patients indicated for surgery for cervical degenerative disease (CDD) will be screened for~     yellow flags using validated tools to assess pain. Cognitive-behavioral therapy (CBT) will be~     used to modify yellow flags in spine patients. All patients at risk will be stratified by~     risk rating and randomly assigned to 2 groups; sham treatment (N=20) or CBT (N=20). The goal~     of this study is to unmask the relationship between psychological distress and clinical~     outcomes in patients undergoing surgical treatment for cervical degenerative disease~     resulting in combinations of neck pain and radiculopathy, and to determine the effectiveness~     of a brief psychological intervention on subset of patients who screen positive for~     psychological distress prior to their surgeries.~   "
29284|NCT03183700|"~     The aims of the present study are to assess the effects of a hrHPV self-sampling test as~     strategies to reach non-attending women in organized cervical screening in comparison with~     standard recall by letter in 8000 women; to evaluate the performance of two self sampling~     devices with and without a preservative buffer and to explore their acceptability among~     invited women and to evaluate a molecular triage approach for management of HPV positive~     women in self sampling collected material by HPV genotyping and DNA methylation marker panel~   "
29285|NCT03183687|"~     This wellness initiative is aimed to assess the activity level, sleep habits and nutrition~     status of resident physicians. The investigators will monitor for improvement in these areas~     with initiation of an exercise program suited to the lifestyle needs of resident physicians.~   "
29286|NCT03183674|"~     Observe effects of oxytocin on individuals with autism spectrum disorder~   "
29287|NCT03183661|"~     This is an open-label follow up study to evaluate the safety for the subjects with~     ALLO-ASC-CD injection in phase 1 clinical trial (ALLO-ASC-CD-101) for 36 months.~   "
29288|NCT03183648|"~     This is an open-label follow up study to evaluate the safety for the subjects with~     ALLO-ASC-DFU treatment in phase 2 clinical trial (ALLO-ASC-BI-201) for 23 months.~   "
29291|NCT03183609|"~     This study purpose is to conduct a confirmatory double-blind randomized controlled trial in~     an inpatient setting of the effects of a tightly controlled gluten-free diet (GFD) to improve~     negative symptoms in people with schizophrenia or schizoaffective disorder who have~     antibodies to gliadin (AGA IgG). As part of the project investigators will also confirm~     outcomes such as cognitive symptoms, changes in peripheral and central inflammation as well~     as gut/blood brain barrier permeability.~   "
29292|NCT03183596|"~     The novel introduction of various chest wall blocks such as the Pecs I and II/modified Pecs~     blocks as well as the Serratus Anterior Plane Block have extended the application of~     perioperative regional anesthesia to provide analgesia for breast surgery. However, to our~     knowledge, there are no large studies that truly delineate the optimal injection site for the~     Serratus Anterior Plane Block.~   "
29293|NCT03183583|"~     Prolonged wound drainage after total hip or knee arthroplasty is a very undesirable~     complication, both from medical as patients view. Wound drainage prolongs hospital admission~     and is associated with an increased risk of infection (1) post-operative wound drainage of~     more than 48 hours is associated with an increased infection risk of 42 percent a day in hip~     arthroplasty and 27 percent a day in knee arthroplasty. (2) Patient organizations report that~     wound drainage is considered as one of the most undesirable complications.~      In our hospital, patients undergoing hip or knee arthroplasty are treated according to a~     fast track protocol, in most cases resulting in a hospital admission of only two days. This~     increases the chance that patient's release from hospital will be delayed due to wound~     drainage. The fact that our department recently started to perform hip and knee arthroplasty~     in a daycare setting increases this chance substantially.~      In hemiarthroplasty of the knee, tissue adhesive was used in addition to conventional wound~     closure techniques with monocryl sutures. Resorbable monocryl sutures were used so that the~     usual visit to our outpatient department to remove the sutures was no longer necessary.~     However, we experienced an increase in wound drainage and complications using only monocryl.~     The addition of a tissue adhesive decreased the post-operative wound complication~     drastically. This in mind, we started to use tissue adhesive in regular hip and knee~     arthroplasty as well. With tissue adhesive in addition to conventional staples, we noticed~     good results. These results however, were subjective and not officially recorded.~      In a previous study, good results are reported in decreasing wound drainage with the use of a~     tissue adhesive in addition to staples. Clinical relevance was not reported and the study~     design lacked a cost-effectiveness analysis (3) The increase in cost for the use of the~     tissue adhesive involved was noted by our board of directors. Because lack of a clear medical~     of financial benefit, we were asked to minimize the use of tissue adhesive, resulting in~     usage of tissue adhesive solely in a day care setting, which comprises only 5 to 10 percent~     of our treated population. Previous study reported a decrease in post-operative wound~     drainage when tissue adhesive was used in addition to staples in knee arthroplasty. However,~     no financial benefit is known, therefore this treatment has not been accepted into daily~     practice. In our department, prolonged hospital admission due to wound drainage is not found~     to be uncommon. Our hypothesis is that the addition of tissue adhesive in wound closure after~     hip and knee arthroplasty will significantly decrease post-operative wound drainage, leading~     to a reduced number of admission days. In addition, we expect less patients to return to our~     outpatient clinic for non-regular visits due to wound complications. Expensive bandages are~     used in our standard treatment protocol. Less wound drainage would mean less bandages. All~     these things combined will lead to a reduction in overall health care costs~   "
29294|NCT03183570|"~     The investigators wish to evaluate the feasibility of [18F]FP-R01-MG-F2 PET/CT scanning in~     patients with Idiopathic Pulmonary Fibrosis.~   "
29295|NCT03183557|"~     There has been no comparative data between Zoledronic acid and Zoledronic acid combined with~     active vitamin D in primary and secondary osteoporosis.~   "
29296|NCT03183544|"~     Prostate cancer is the most common cancer in men. Early detection of primary diseases and~     recurrence is crucial for patient counseling and management. Conventional imaging modalities~     (CT-MRI) are limited to detect recurrence.~      Choline-based PET/CT is currently widely used as primary staging tool in prostate cancer and~     in patients with suspicious recurrent disease.~      Compared to choline-based tracers, 68Ga-PSMA ligands have been shown to have a higher~     diagnostic efficacy and to increase the detection of metastases even at low PSA levels. The~     most widely used prostate-specific membrane antigen (PSMA) ligand is PSMA-11. A supplier,~     ANMI, has developed a kit formulation of PSMA-11 which will be test in this clinical trial.~   "
29297|NCT03183531|"~     The objective of present study was to evaluate clinical and laboratory characteristics of~     febrile neonate and describe the incidence of SBI in febrile neonates. Secondarly~     investigators aimed to test usefulness of major protocols and new protocol in evaluating only~     febrile neonate.~   "
29298|NCT03183518|"~     To evaluate the skin irritation and sensitization potential of a cosmetic facial product,~     under exaggerated conditions of use with controlled product application and under supervision~     of a dermatologist.~   "
29299|NCT03183505|"~     The purpose of this study is to evaluate the safety and efficacy of Anyu Peibo Capsule~     comparing with placebo in the treatment of Chinese Patients with Depression. And to provide~     some scientific evidence for protocol designing in following phase Ⅲ clinical trial.~   "
29300|NCT03183492|"~     This study will evaluate the persistence, immunogenicity and safety of Havrix® (hepatitis A~     vaccine) in adults primed in infancy. The enrolled subjects will be assessed for circulating~     antibodies against hepatitis A and will also receive a challenge dose of Havrix Adult~     vaccine. In the present study, the anamnestic response will be assessed 30 days after the~     challenge dose.~   "
29301|NCT03183479|"~     Allogeneic blood products transfusions are often necessary to treat perioperative bleeding in~     patients undergoing complex scoliosis surgeries. A prospective, randomized trial is designed~     to evaluate if the infusion of fibrinogen concentrate may reduce allogeneic blood transfusion~     in patients undergoing scoliosis surgery. Eligible patients will be randomly assigned to~     treatment group (fibrinogen concentrate infusion) and control group (normal saline infusion),~     and functional fibrinogen will be measured to guide the infusion of fibrinogen concentrate.~     Perioperative blood loss, intraoperative blood loss, and the amount of perioperative~     allogeneic blood transfusion will be compared between the two groups to determine the effect~     of fibrinogen concentrate infusion.~   "
29302|NCT03183466|"~     The purpose of this study was to randomly classify the upper third of the subscapularis in~     1/2 of the rupture patients as preoperative group (arthroscopic and arthroscopic debridement~     group) and the difference between clinical and clinical scores.~   "
29303|NCT03183453|"~     Confabulators consistently generate false memories without intention to deceive and with~     great feeling of rightness. However, there is currently no known effective treatment for~     them. In order to fill this gap, we performed a neuropsychological treatment in two groups of~     confabulators: experimental vs. control (ClinicalTrials.gov ID: NCT02540772).~      Now, we intend to replicate the treatment with a larger sample of confabulators and with~     other two control groups: non-confabulator patients with brain injury and healthy individuals~   "
29315|NCT03183297|"~     This will be a double-blind, placebo-controlled study with a 4-way crossover design with~     subjects administered study drug (JMI-001), placebo, fexofenadine alone and naproxen alone on~     different study days, in conjunction with a quantity of alcohol estimated to be sufficient to~     produce a hangover the next day. The primary objective of the study is the evaluate the~     pharmacokinetics (PK) and pharmacodynamics (PD) of two different doses of JMI-001~     administered in conjunction with alcohol to healthy adult subjects.~   "
29304|NCT03183440|"~     Allergies are increasing worldwide affecting 30-40% of the population. Among this, Atopic~     Dermatitis (AD) is the earliest and the most common manifestation of allergic diseases~     (prevalence 20%). Recent studies have shown that allergies were associated with a disruption~     of the gut microbial 'balance' suggesting that the use of nutritional intervention very early~     in life may restore an optimal pattern of microflora aiming at improving the host's health.~     So far, most human intervention studies have mainly focused on improving postnatal infant~     colonization. Our study will test the hypothesis that a maternal antenatal prebiotics~     (GOS/inulin) supplementation may be superior to placebo for AD prevention in high-risk~     children.~   "
29305|NCT03183427|"~     This study aims to determine size of corpus callosum on midsagittal MR scan in patients with~     a pineal cyst and to compare it with the control group without a pineal cyst.~   "
29306|NCT03183414|"~     To establish the correlation between echocardiographic parameters of the RV, measured with~     TEE and the right ventricular ejection fraction (thermodilution). To identify a time in the~     perioperative process when RV dysfunction occurs.~   "
29307|NCT03183401|"~     The DENACAPST programme represents an important initiative to provide near nation-wide~     roll-out of an important cancer surveillance program for childhood cancer survivors. The~     program is based on internationally recognized standards in cancer surveillance, which were~     developed by the International Guideline Harmonization Group (IGHG) with support of all~     relevant stakeholders in cancer survivorship research and clinical work in Europe, Canada and~     the United States and recognized French recommendations about breast screening for women at~     high risk of cancer.~      With this programme, French centers organized themselves to provide to childhood cancer~     survivors adequate medical attention, which includes close medical surveillance for~     breast/thyroid cancer where appropriate, based on adequate risk stratification.~      The aim of the study is to analyze if the recommendations about breast and thyroid cancer~     screening are followed in this population and secondly to provide more informations about~     these second cancers and about the screening.~   "
29308|NCT03183388|"~     New treatments to help to reduce the emotional dysregulation of mood disorders are critically~     needed. This is a study of an emotional dysregulation psychotherapy treatment in which~     subjects will learn skills to help to down-regulate maladaptive emotional responses and learn~     beneficial, healthy habits. Investigators will perform symptom and behavioral assessments and~     scanning prior to the treatment and will then repeat scanning, symptom and behavioral~     assessments at the midpoint, and after the psychotherapy is completed. This collected~     information will assess whether the treatment can improve functioning of emotion regulation~     brain circuitry.~   "
29309|NCT03183375|"~     Objectives~      Primary objectives:~        -  To determine the efficacy of Hydroxyurea in the study participants.~        -  Hypothesis: The study will result in either maintenance or rise in hemoglobin as~          compared to the control treatment.~      Secondary objectives:~        -  To determine the compliance of Hydroxyurea in study participants.~        -  To determine the safety of Hydroxyurea in the study participants. Design and Outcomes~      An open label randomized controlled trial to test the efficacy and safety of Hydroxyurea on~     beta thalassemia major patients. It is a six months study. Findings of physical examination,~     vital sign variables, laboratory variables and ultrasound at baseline, during and end of the~     study will be listed. Schedule of intervention is mentioned in section 6.1. later in the~     protocol.~      Interventions and Duration Hydroxyurea will be given to the participants in intervention arm~     along with the standard treatment if thalassemia (blood transfusion and iron chelation~     therapy) and the control arm will receive the standard treatment (blood transfusion and iron~     chelation therapy) only. Each participant will be followed up for 6 months after initiating~     the intervention. Intervention will be given for 6 months or until the participant withdraws~     from the study or due to any reason, the investigator stops the intervention.~      Sample Size and Population This pilot study will be done on 100 patients initially.~     Stratified randomization will be done on the basis of presence of Xmn polymorphism. And the~     study population will be assigned to intervention or control arm randomly through a computer~     software (randomizer.org).~   "
29310|NCT03183362|"~     The aim of this randomized controlled trial is to determine whether the use of barbed sutures~     to close uterine incision at cesarean section is associated with more postoperative adhesions~     compared with conventional sutures or not.~   "
29311|NCT03183349|"~     20 subjects suffering from non restorable maxillary premolar teeth will be randomly devided~     into two groups. the selected teeth will be extracted and immeiate implants will be placed in~     all subjects. the first group will recieve deprotienized bovine bone (tutogen) to fill the~     buccal space between the implant and the bone, the second group will recieve platlet rich~     fibrin to fill the buccal space between the implant and the bone~   "
29312|NCT03183336|"~     20 subjects presenting with horizontal mandibular ridge width less than 5 mm were selected~     and randomly divided two groups (10 in each group). the first group received interpositional~     block grafts (harvested from the chin and ramus) covered with Platelet-rich fibrin membrane.~     the second group received onlay block grafts (harvested from the chin and ramus) and covered~     with Platelet-rich fibrin membrane. the grafts are left for 4 months. the alveolar ridge~     width dimensions is then measured using radiographic analysis using cone-beam computed~     tomography scans~   "
29313|NCT03183323|"~     ITISHOPE4HF is a randomized controlled trial of telerehabilitation in a heart failure~     population. The goal is to evaluate if a home-based telerehabilitation project can increase~     physical activity in heart failure patients. Patient will be provided telerehabiliation or~     advice on physical activity (standard care).~   "
29314|NCT03183310|"~     The effect of chlorpromazine (Largactil) on esophageal sensitivity will be investigated in~     this study. Overnight fasted subjects will be asked to fill out 2 questionnaires to assess~     the emotional status before their onset of the stimulation tests. The multimodal stimulation~     probe will be positioned through the mouth in the distal esophagus.~      After the ingestion of the stimulation probe, 10mg of chlorpromazine or placebo (saline) will~     be slowly administered via intravenous injection. Hereafter the multimodal stimulation tests~     will be initiated.~      Esophageal sensitivity will be assessed by performing thermal, mechanical, electrical and~     chemical stimulation of the esophagus. The chlorpromazine condition will be compared with a~     placebo condition, this will be organised on 2 separate study visits in a randomised order.~   "
29316|NCT03183284|"~     Immune thrombocytopenic purpra(ITP) is an autoimmune thrombocytopenic syndrome characterized~     by decreased platelet count and increased risk of bleeding, primarily due to immunoglobulins~     G(IgG)autoantibodies opsonizing the individual's platelets,resulting in markedly enhanced Fc~     receptors(FcR)-mediated phagocytosis and destruction by macrophages in the~     reticuloendothelial system within spleen Severe ITP defined as :Patients who have clinically~     relevant bleeding that mean that patients have bleeding symptoms at presentation sufficient~     to mandate treatment,or occurrence of new bleeding symptoms requiring additional therapeutic~     intervention with a different platelet-enhancing agent or an increased dose.~   "
29317|NCT03183271|"~     The aim of this research project is to test the local response and the acute toxicity (which~     can be observed within 90 days).~   "
29318|NCT03183258|"~     This pilot study aims to validate the use of vascularised donor-derived sentinel skin flaps~     for diagnosing rejection in pancreas transplantation. The aim of the study is to investigate~     the use of sentinel skin flaps in clinical practice and assess whether rejection occurs~     concordantly or discordantly between the skin flap and the transplanted abdominal organs. If~     successful, sentinel skin may allow improved immune surveillance and thereby facilitate~     earlier treatment of rejection with subsequent improvements in allograft survival and patient~     morbidity.~   "
29319|NCT03183245|"~     The main purpose of this study is to compare the Human Acellular Vessel (HAV) with~     arteriovenous fistula (AVF) when used for hemodialysis access~   "
29320|NCT03183232|"~     In this study, effects of γδT cells on human Lung Cancer in combination with tumor reducing~     surgery, for example, cryosurgery going to be investigated~   "
29321|NCT03183219|"~     In this study, effects of γδT cells on human Liver Cancer in combination with tumor reducing~     surgery, for example, cryosurgery going to be investigated.~   "
29322|NCT03183206|"~     In this study, effects of γδT cells on human Breast Cancer in combination with tumor reducing~     surgery, for example, cryosurgery going to be investigated.~   "
29323|NCT03183193|"~     Non-alcoholic fatty liver disease (NAFLD) is a condition of excessive hepatic lipid~     accumulation in subjects that consume less than 20g ethanol per day, without other known~     causes as drugs consumption or toxins exposure. In Western countries, the rate of this~     disease lies about 30% in the general adult population. The process of developing NAFLD can~     start from simple steatosis to non-alcoholic steatohepatitis (NASH), which eventually can~     lead to cirrhosis and hepatocellular carcinoma in the absence of alcohol abuse. Liver biopsy~     is considered the gold standard of steatosis, fibrosis and cirrhosis. However, it is rarely~     performed because it is an invasive procedure and investigators are focusing in the~     application of non-invasive liver damage scores for diagnosis.~      The pathogenesis of NAFLD is multifactorial and triggered by environmental factors such as~     unbalanced diets and overnutrition as well as by lack of physical activity in the context of~     a genetic predisposition. Nowadays, the treatment of NAFLD is based on diet and lifestyle~     modifications. Weight loss, exercise and healthy eating habits are the main tools to fight~     NAFLD. Nevertheless, there is no a well characterized dietary pattern and further studies are~     necessary.~      With this background, the general aim of this project is to increase the knowledge on the~     influence of nutritional/lifestyle interventions in obese patients with NAFLD, as well as~     contribute to identify non-invasive biomarkers/scores to early diagnosis of this pathology in~     future obese people.~   "
29324|NCT03183180|"~     According to American Heart Association criteria, patients who have had Rheumatic Fever (RF)~     should be treated with antibiotic prophylaxis. Continuous prophylaxis is recommended in~     patients with well-documented histories of RF and in those with evidence of rheumatic heart~     disease.~      There is a limited data regarding adherence of patients to treatment and efficacy of~     treatment.~      In this study, patients with RF who are older than 21 years will be collected from a~     computerized database of 'Maccabi Healthcare Services', one of the biggest Israeli Health~     Funds. Patients will be assigned to the study after obtaining informed consent.~      Previous adherence to antibiotic prophylaxis will be examined according to computerized~     database of drugs which were issued to the patient since RF diagnosis.~      Past history of cardiac involvement, including past Echocardiograms, will be collected from~     computerized database. In addition, the current cardiac state will be assessed by an~     experienced cardiologist, including a full new Echocardiogram examination.~   "
29325|NCT03183167|"~     Intracerebral hemorrhage [ICH] is the most feared sub-type of stroke, associated with a high~     mortality rate up to 50% and thus leaving large proportions of patients in functionally~     dependent states. In recent years randomized trials have failed to provide an effective~     intervention to improve functional outcome in ICH. Therefore, evidence regarding acute~     therapeutic interventions as well as secondary treatment approaches is still limited.~      The present monocentric longitudinal study on spontaneous ICH patients is based on a~     prospective institutional stroke registry including all hemorrhagic stroke patients treated~     at a German University Hospital, Department of Neurology, over a 10 year time frame~     (2006-2015). The main aim of this investigation, besides analyses of epidemiological aspects,~     will be (i) to identify possible treatment targets influencing functional outcome, and (ii)~     to evaluate existing therapeutic strategies in ICH care.~   "
29326|NCT03183154|"~     The objective of this study is to explore the impact of initiation of ART with different~     regimens in naïve MSM (in the setting of acute and chronic HIV-infection) on the probability~     of transmission of HIV by mathematical modeling.~   "
29327|NCT03183141|"~     Subjects who had a CDI recurrence in Study SERES-012 within 8 weeks of receipt of study drug~     will receive an oral dose of SER-109 in 4 capsules once daily for 3 consecutive days. The~     purpose of this study is to assess safety and efficacy of SER-109 in reducing recurrence of~     Clostridium difficile infection (CDI) in adults who had a CDI recurrence within 8 weeks after~     receipt of SER-109 or Placebo in Study SERES-012.~   "
29328|NCT03183128|"~     Subjects will receive an oral dose of SER-109 in 4 capsules once daily for 3 consecutive days~     in Treatment Group I or matching placebo once daily for 3 consecutive days in Treatment Group~     II. The purpose of this study is to demonstrate the superiority of SER-109 vs placebo to~     reduce recurrence of CDI in adults up to 8 weeks after initiation of treatment.~   "
30828|NCT03163537|"~     Observation of disturbing factors in the operating room and comparison between day and night~     shift. The investigators have chosen to observe kidney transplantations, since this type of~     operation has the same priority during day and night. Stress levels of surgeons will be~     measured using the HealthPatch.~   "
29329|NCT03183115|"~     Esophageal cancer is a highly lethal disease, and its incidence is still increasing in the~     world. Recent advances in image-enhanced techniques such as Lugol chromoendoscopy and narrow~     band imaging, the number of patients with early esophageal squamous cell neoplasias (ESCNs)~     detected has markedly increased. Endoscopic submucosal dissection (ESD) enables en bloc~     resection of the neoplasia, and the resected specimen allows for a pathological assessment to~     evaluate the curability. However, the patients who received complete ESD for early ESCNs~     frequently developed metachronous recurrence. The cumulative metachronous recurrence rate at~     5 years was 50%, and the mean annual incidence of newly diagnosed metachronous tumors was~     10%. Among them, those with speckled lugol staining pattern over the esophageal background~     mucosa have the highest risk and should be seen as a precancerous lesion of ESCCs. This issue~     is gaining attention in the era of endoscopic treatment, but currently there was no~     appropriate strategy to prevent the tumor recurrence in these high-risk subjects.~      Endoscopic radiofrequency ablation (RFA) is a rapidly evolving therapeutic modality, and~     recent studies have shown its efficacy and safety for eradicating for flat type early ESCNs.~     To search a best strategy for the prevention of ESCNs, the investigators thus propose a~     hypothesis that the preemptive RFA for esophageal speckled lugol background mucosa may~     prevent the metachronous neoplastic recurrence after complete endoscopic resection.~   "
29330|NCT03183102|"~     The purpose of this pilot study is to determine if suppressing estrogen in premenopausal~     women results in changes in gut microbiota and if dietary flaxseed modulates these changes.~   "
29331|NCT03183089|"~     The objective of this study is to evaluate the efficacy of Rohto Dry-Aid® in comparison to~     Systane® Ultra on visual function and tear film stability in patients diagnosed with Dry Eye.~   "
29332|NCT03183076|"~     The Atkins Diet Modified (ADM) is the best alternative treatment for drug-resistant epilepsy,~     There is a high prevalence worldwide , especially in Latin American countries, including~     Mexico.~      Low income earners, many of which do not have a social security, must meet the high costs by~     Antiepileptic Drugs (AEDS), which in addition should be used in conjunction or combination~     therapy, because monotherapy is insufficient .~      The diet adkins makes some changes in the traditional food habits by others that are~     accessible and not necessarily expensive, whose mechanism allows for better control of the~     seizures.~   "
29333|NCT03183063|"~     Deep vein thrombosis (DVT) occurs when a blood clot forms in a deep vein, typically in the~     lower extremities. Pulmonary embolism (PE) occurs when a DVT clot (or fragment) breaks free~     and travels through the heart to the pulmonary arteries (having to do with the lungs) and~     lodges in an artery causing a partial or complete blockage. PE is difficult to diagnose due~     to the non-specific signs and symptoms patients have with this condition such as a cough,~     shortness of breath, increased heart rate, blood tinged sputum, low oxygen levels.~      The standard test to diagnose PE is the Pulmonary Computed Tomography Angiogram (CTA). This~     can be prohibitive with some patients due to the amount of radiation exposure as well as the~     complications associated with the need to use intravenous (IV) contrast. In patients not~     eligible for CTA, the other option for diagnosis is a ventilation-perfusion (V/Q) single~     photon emission computed tomography (SPECT) scan. Though this is often prohibitive due to~     transport to Nuclear Medicine dept., prolonged test time, no test during off hours, etc. In~     this study the investigators are looking at an alternative method of diagnosing PE's in the~     Emergency Department where the investigators look at the breathing and blood flow to the~     lungs thru respiratory gated non-contrast CT (commonly called 4DCT).~      The investigators hypothesize that respiratory induced blood mass change in the lungs will~     allow the identification of under-perfused lung regions. The investigators did a prelimary~     study and tested this theory in cases with low oxygen levels, narrowing of the blood vessels,~     airway obstruction, comparing 4DCT with SPECT scan. The images compared well. It is unknown,~     however, if this process works to detect perfusion defects due to PE where the perfusion is~     obstructed and breathing normal.~      15 participants will be enrolled with a diagnosis of PE by CTA. Each will receive SPECT/CT~     and 4DCT imaging on the same day. Respiratory induced blood mass change images will be issued~     from the 4DCT and compared to the SPECT/CT images.~   "
29334|NCT03183050|"~     Clinical guidelines for women with early stage breast cancer integrate genomic tumor~     profiling tests such as the Oncotype DX Recurrence Score to refine recurrence estimates and~     systemic therapy selection when combined with existing markers. Guidelines suggest that the~     25% with a high Score benefit from chemotherapy and the 50% with a low Score can safely avoid~     chemotherapy. Many challenges remain to maximize the benefits of testing prior to release of~     trial results in the next year. Strong clinical communication can impact proximal outcomes of~     patient comprehension, treatment preferences and satisfaction, involvement in care decisions~     as well as longer-term outcomes of treatment adherence and QOL. These proximal outcomes can~     be influenced by patient activation interventions utilizing a question prompt list (QPL). In~     the context of patients receiving Oncotype DX testing, the QPL could allow them to better~     understand the rationale for their oncologist's treatment recommendation, what it means for~     managing their disease, and encourage alignment of treatment preferences and selection with~     the Recurrence Score. Research is conducted in two phases to test the feasibility and impact~     of the QPL. In Phase 1, the draft QPL will be revised based on in-depth interviews with~     patients (N=20) and medical oncologists (N=10). Phase 2 will be a single-arm trial (N=75) to~     demonstrate feasibility and preliminarily assess the impact of the QPL on key outcomes.~   "
29335|NCT03183037|"~     The purpose of this study is to compare the effects of real acupuncture with placebo~     acupuncture or usual care on symptoms of nerve damage from chemotherapy.~   "
29336|NCT03183024|"~     Study to determine the efficacy of benralizumab when compared to placebo in patients with~     chronic hives that do not respond to antihistamine treatment~   "
29337|NCT03183011|"~     This study is evaluating how MRI after CRT can provide key insights regarding LV function,~     structure, and mechanics resulting from CRT in patients with or without LV scar and inform~     optimal pacing strategies. The expected accurate and reproducible response assessment with~     cardiac MRI has important implications for evaluating CRT outcomes in clinical trials, and~     the insights from the post-CRT MRI promise to improve implementation of CRT.~   "
29338|NCT03182998|"~     This randomized phase III trial studies how well decision aids work in improving knowledge in~     patients with prostate cancer. Decision aids may improve patients' knowledge of their~     condition and options for treatment, and may also help when talking with their doctor.~   "
29367|NCT03182595|"~     An open‐label, single centre, nonrandomized clinical study in healthy volunteers, with~     intervention over a 13--‐week period. After written informed consent, subjects will undergo~     screening evaluations (Visit 1). One week after visit 1, subjects who meet the selection~     criteria will enter a run--‐in period of 8 weeks where participants will receive paracetamol~     1g tablet and collect a blood sample at monthly intervals (visits 2, 3 and 4). A final visit~     for safety assessment will take place at week 13 (visit 5). Blood samples will be used to~     quantify P, PG e PS.~   "
29339|NCT03182985|"~     The investigators intend to measure the health impact of a dietary intervention known as time~     restricted feeding (TRF) on patients with metabolic syndrome (three or more of: increased~     waist circumference, abnormal cholesterol levels, elevated blood pressure, or elevated blood~     sugar). The investigators will enroll patients with metabolic syndrome who eat for ≥ 14 hours~     per day and will ask participants to reduce daily oral intake to 10 hours per day. The~     investigators will assess the impact of this dietary change using measures obtained before~     and after a 12 week intervention period, including body mass index, blood pressure, various~     lab parameters and blood sugar levels (assessed using a continuous glucose monitor). The~     investigators will assess for compliance with TRF using a Smart Phone application~     (myCircadianClock (mCC) app).~   "
29340|NCT03182972|"~     This study will assess the current practice of medication reconciliation among pharmacists in~     the selected institutions with a view to making an intervention to address gaps discovered~   "
29341|NCT03182959|"~     This study is being done to see whether Avmacol®, a dietary supplement made from broccoli~     sprout and seed extract powder, induces changes in inner cheek cells that may be protective~     against environmental toxins such as tobacco.~      There are three main goals of the study:~        1. To learn whether the dietary supplement, Avmacol®, can stimulate cheek cells to repair~          damage from environmental toxins;~        2. to learn how the body metabolizes Avmacol®, by measuring its byproducts in the~          participant's urine and blood;~        3. to learn whether the immune system can be stimulated by Avmacol®, by studying the~          natural killer cells and T cells in the participant's blood.~   "
29342|NCT03182946|"~     This study evaluates the impact of platelet transfusion on geriatric patients with platelet~     dysfunction from Traumatic Brain Injury. The authors hypothesize that patients will recover~     better if their platelet dysfunction is corrected with platelet transfusion.~   "
29343|NCT03182933|"~     Study will evaluate the effect of liposomal bupivacaine versus standard bupivacaine on~     physical therapy measures and pain scores as well as opiate consumption.~   "
29344|NCT03182920|"~     The purpose of this study is to look at the amount of study drug that gets into the blood~     stream and how long it takes the body to get rid of it by comparing the results of healthy~     elderly participants to those of healthy young participants. The tolerability of the study~     drug will be evaluated. Information about any side effects that may occur will also be~     collected.~      This study will last up to approximately 19 days, not including screening. This study~     requires either one (Group 2) or two (Group 1) stays at the clinic each of at least four~     days/three nights. Participants will return for a follow-up seven days after last dose of~     study drug. Screening is required within 28 days prior to Day 1.~      This study is for research purposes only and is not intended to treat any medical condition.~   "
29345|NCT03182907|"~     The primary objectives of this study are to evaluate the pharmacokinetics (PK), safety, and~     tolerability of bezlotoxumab in children aged 1 to <18 years of age with a confirmed~     diagnosis of Clostridium difficile infection (CDI) who are receiving antibacterial drug~     treatment. The primary hypothesis is that the area under the concentration-time curve from 0~     to infinity (AUC0-inf) of bezlotoxumab after treatment of pediatric participants with~     bezlotoxumab is similar when compared to the AUC0-inf of bezlotoxumab after treatment of~     adults with bezlotoxumab,~   "
29346|NCT03182894|"~     Trial Design This is an open label, single-arm, phase IB/II trial to evaluate the safety,~     tolerability and anti-tumor efficacy of epacadostat (INCB024360) in combination with~     pembrolizumab (MK-3475) plus azacitidine in patients with chemo-refractory MSS mCRC.~      The phase 1B portion of the study will evaluate the safety, tolerability and RP2D of~     epacadostat (INCB024360) in combination with pembrolizumab plus azacitidine in subjects with~     chemo-refractory MSS mCRC without any further standard treatment options.~      The phase 2 portion of the study will evaluate the efficacy and safety of epacadostat~     (INCB024360) in combination with pembrolizumab plus azacitidine in subjects with~     chemo-refractory MSS mCRC without any further standard treatment options.~      In both phase IB and phase 2 portions, patients will receive the combination of azacitidine,~     pembrolizumab and epacadostat (INCB024360) for the first 18 cycles (Cycles 1-18). Beginning~     with Cycle 19 through Cycle 35, patients will receive the combination of pembrolizumab and~     epacadostat (INCB024360).~   "
29347|NCT03182881|"~     Objective. To compare the effectiveness of myofascial therapy against manual lymphatic~     drainage in the reduction of sequelae secondary to conservative surgery and radiotherapy in~     women who survived breast cancer.~      Design. Randomized clinical trial. Site. Faculty of Physiotherapy of the University of~     Valencia. Participants. Twenty-four patients were included in the study. Interventions. 13~     patients were randomly assigned to treatment with myofascial therapy and 11 to receive manual~     lymphatic drainage.~      Main measurements. Pain measured using the Visual Analogue Scale, shoulder joint range,~     shoulder functionality using the DASH questionnaire, quality of life assessed using the~     FACT-B questionnaire, and the depressed status of the patients using the PHQ-9 . All of this~     was assessed before and after treatment, and one month later as follow-up.~   "
29348|NCT03182855|"~     This randomized, controlled trial compares the anti-thrombotic effect of cangrelor and~     ticagrelor on platelet activity in patients with acute ST-elevation myocardial infarction.~      Patients will receive either prehospital ticagrelor (180 mg - crushed) or in-hospital~     cangrelor (bolus 30 μg/kg within 1 minute followed by infusion (4 μg/kg/minute) for two~     hours) followed by 180 mg ticagrelor.~      The primary study end-point is platelet reactivity at sheath insertion, at the end of the PCI~     procedure (before sheath removal) and two hours after PCI is initiated. The secondary~     end-point is the proportion of patients with inappropriate or harmful P2Y12 administration.~   "
29368|NCT03182582|"~     Bacterial load is frequently associated with impaired healing of chronic wounds. As well,~     sharp debridement is often associated with pain, causing patient distress, and thereby~     occasionally contributing to inadequacy of debridement, leading to a delay in wound healing.~     The purpose of this study is to assess the efficacy of the Sciton Laser in reducing bacterial~     load and patient distress in patients with chronic wounds, in efforts to expedite the wound~     healing process.~   "
29369|NCT03182569|"~     Use of a flexible subcutaneous catheter improves comfort in patients with DKA compared to the~     usual treatment with a metal needle.~   "
30829|NCT03163524|"~     This is a randomised controlled trial to test the impact of a modified e-coupon service,~     delivered through SMS, on uptake of sexual and reproductive health services among women~     calling a free hotline in Uganda.~   "
29349|NCT03182842|"~     A randomized, double-blinded, single center, parallel design pediatric study, on 45 subjects~     with type 1 diabetes (T1D), aged six to 15 (inclusive) years, measuring sensor time in~     glucose values within range 3.9 - 10 mmol/l (70 - 180 mg/dl) achieved using the FreeStyle~     Libre Flash Glucose Monitoring System (FGM - intervention, Abbott Diabetes Care, California,~     USA) versus Self-Monitoring Blood Glucose (SMBG - control).~      Study duration will be two weeks per subject and two weeks overall, it will take place at~     youth summer camp for children with T1D. Main inclusion criteria include age of six to 15~     (inclusive) years, clinical diagnosis of T1D for at least six months, at least three months~     of current use of insulin pump therapy, HbA1c between 6.3 and 10 % (both inclusive), no other~     chronic medical conditions (beside treated hypothyroidism and celiac disease) and no current~     medications (other than insulin) (detailed list of inclusion and exclusion criteria list can~     be found at section 6).~      The objectives of this clinical investigation is:~      1. to evaluate the efficacy of glucose control using the FreeStyle Libre FGM in children with~     T1D during two weeks of summer camp.~   "
29350|NCT03182829|"~     This trial is conducted to assess the performance and handling of the in vitro diagnostic~     (IVD) device for oral direct factor Xa and thrombin inhibitors from urine samples of patients~     on treatment with direct oral anticoagulants Apixaban, Edoxaban, Rivaroxaban, and Dabigatran~     (DOAC) in an actual point-of-care (POCT) setting in comparison to results obtained by liquid~     chromatography tandem mass spectrometry (LC-MS/MS) from urine samples.~      This trial is conducted to assess the performance and handling of the IVD for oral direct~     factor Xa and thrombin inhibitors from urine samples of patients on treatment with DOACs in~     an actual point-of-care setting in comparison to results obtained by liquid chromatography~     tandem mass spectrometry (LC-MS/MS) from urine samples.~   "
29351|NCT03182816|"~     This is a single-arm, open-label, one center clinical study, to determine the safety and~     efficacy of infusion of autologous T cells engineered to express immune checkpoint antibodies~     (CTLA-4 and PD-1) and chimeric antigen receptor targeting epidermal growth factor receptor~     (EGFR-CAR) in adult patients with EGFR positive, advanced recurrent or refractory malignant~     solid tumors.~   "
29352|NCT03182803|"~     This is a single-arm, open-label, one center clinical study, to determine the safety and~     efficacy of infusion of autologous T cells engineered to express immune checkpoint antibodies~     (CTLA-4 and PD-1) and chimeric antigen receptor targeting mesothelin (mesoCAR-T) in adult~     patients with mesothelin positive, advanced recurrent or refractory malignant solid tumors.~   "
29353|NCT03182790|"~     The present study will examine (1) the effectiveness of regular messages and~     semi-personalized instant messaging with AWARD brief advice and active referral to smoking~     cessation (SC) services and (2) explore the use of CBPR model to build capacity and to engage~     community partners in taking on this important public health issue for sustainability in the~     community. In addition, a process evaluation will be conducted to assess the effectiveness of~     the recruitment activity and how it is linked with the overall program outcomes.~   "
29354|NCT03182777|"~     Patients with cardiac channelopathies needing restorative dental treatment will be included~     in two sessions of the study, using local dental anesthetic: lidocaine 2% with epinephrine~     and lidocaine 2% without vasoconstrictor. The safety of the use of two cartridges (3.6 mL)~     will be evaluated. The patients will be their own control and will be assessed by Holter~     monitoring for 28 hours, blood pressure measurement and anxiety measuring.~   "
29355|NCT03182764|"~     Aim: to collect further information on issues related to tobacco control which should be~     addressed and advocated in further tobacco control measures in Hong Kong~      The objectives of this policy-related survey are as follows:~        1. to update information on trends and prevalence of secondhand smoke, smoking attributable~          health effects, cessation services, and e-cigarette;~        2. to investigate the level of public support on current and future tobacco control~          measures and taxation;~        3. to address the timely impacts of smoke-free policies, public support for further tobacco~          control measures and assist COSH in shaping policy direction for government.~      Current study is a cross-sectional retrospective telephone survey based on questionnaires. In~     total, 5,104 subjects will be randomly selected for a telephone interview. The subjects will~     be categorized into three groups, i.e. never smokers (1,700), ex-smokers (1,700) and current~     smokers (1,704). They will be required to answer a questionnaire via telephone. All data~     shall be collected using a Computer Assisted Telephone Interview (CATI) system, which allows~     real-time data capture and consolidation. All interviews shall be conducted anonymously.~     Analysis of survey data will aim to identify current opinion on tobacco control policies and~     implications for future policies. Analyses will be controlled for confounding variables as~     required by stratification into sub-groups based on important pre-defined characteristics~     and/or by multivariate analysis. Comparison with past trends and, where possible,~     extrapolation of future trends will be explored. Weights will be applied to adjust for the~     sex and age of Hong Kong population, and to handle the over-sampling issues of current~     smokers. The data analysis will be conducted by statisticians.~   "
29356|NCT03182751|"~     A single-center, prospective randomized study. Consecutive patients presenting with~     intertrochanteric hip fractures will be treated with tranexamic acid. Treatment will be~     initiated in the emergency department according to a previously studied protocol for trauma~     patients.~   "
29357|NCT03182738|"~     The purpose of this study is to use technology to improve symptom status and ultimately~     improve patient centered outcomes in people living with HIV/AIDS (PLWHA). The primary purpose~     of the intervention (VIP-HANA) is to improve symptom status. The investigators hypothesize~     that VIP-HANA will improve symptom frequency and intensity.~   "
29381|NCT03182413|"~     Study Objectives: THN102 is a new combination between modafinil and flecainide low-dose, a~     documented glial connexin inhibitor. Efficacy of THN102 was compared to modafinil and to~     placebo on parameters impaired by total sleep deprivation (SD, lasting 40h).~      Methods: 20 healthy male subjects participated in a double-blind, randomised,~     incomplete-block 3-period cross-over trial involving 5 treatments (n=12 per group): placebo~     (PBO), modafinil 100 mg (MOD), and combinations THN102 (modafinil 100 mg and 1, 3 or 9 mg~     flecainide as THN1, THN3 and THN9), as 3 oral doses over 18h.~   "
30763|NCT03164382|"~     This trial was designed to investigate whether the survival outcome, response rate and safety~     of hepatic arterial infusion of oxaliplatin, fluorouracil/leucovorin regimens for patients~     with Barcelona-Clinic Liver Cancer (BCLC)-C stage hepatocellular carcinoma was superior than~     those of the standard treatment with sorafenib or not.~   "
29358|NCT03182725|"~     Postural orthostatic tachycardia syndrome (POTS) occurs in approximately 500,000 Americans,~     but predominates in women with a 5:1 ratio. Patients with POTS experience debilitating~     tachycardia upon postural changes such as standing that impairs their quality of life.~     Tachycardia is clinically defined as a heart rate greater than 100 beats/min; and in POTS~     patients, the prolonged heart rate increase is greater than 30 beats/min or increases to 120~     beats/min within the first ten minutes of a diagnostic tilt table test without postural~     hypotension. There are currently no effective treatment methods for POTS. However, several~     studies suggest Ivabradine could be a main treatment option for POTS because Ivabradine~     specifically inhibits the f-channels (If) within the sinoatrial (SA) node, which slows the~     heart rate. Currently in the US, Ivabradine is mainly prescribed to treat chronic heart~     failure. It is well tolerated in patients, but it is not commonly prescribed for POTS. It has~     been also used for treatment of inappropriate sinus tachycardia with good benefit. The~     hypothesis for this experiment is that Ivabradine will reduce tachycardia and improve~     functional status in patients with POTS.~   "
29359|NCT03182712|"~     The aim of this study was to verify the effect of a combined supplementation [n-3 PUFA (known~     to induce anti-inflammatory effects) plus vitamin E (known for its antioxidant properties)]~     on lipidic, glycemic, redox status and inflammatory parameters in type 2 diabetic patients.~     In addition, considering that exercise, at high intensities, can induce a transient~     inflammatory state and increase oxidative stress (OS) markers, the investigators tested if~     our nutritional intervention could attenuate this response within this population (thus,~     using high intensity exercise as inductor of acute inflammatory/OS state).~   "
29360|NCT03182699|"~     Background:~      Calcimimetic therapy has been shown to reduce systemic FGF23 levels, which themselves are~     associated with left ventricular hypertrophy (LVH) in chronic kidney disease (CKD).~      Methods/design:~      This is a randomized multicenter trial in which the effect of etelcalcetide in comparison to~     alfacalcidol on LVH and cardiac fibrosis in hemodialysis patients with secondary~     hyperparathyroidism (sHPT) will be investigated.~      The investigators will perform a comparative trial testing etelcalcetide vs. alfacalcidol~     treatment on top of conventional HPT therapy for 12 months. A total of 62 hemodialysis~     patients with sHPT and LVH will be enrolled in the study. After a washout of all calcimimetic~     and vitamin D treatment, subjects will be randomized at 1:1 ratio to either etelcalcetide or~     alfacalcidol. The participants will undergo cardiac imaging consisting of cardiac resonance~     imaging (cMRI) and strain echocardiography before and at baseline and one year. Etelcalcetide~     or alfacalcidol will be administered intravenously three times per week following chronic~     hemodialysis treatment.~      The primary end point will be a change in left ventricular mass index (LVMI) measured in~     g/m2. As secondary end points the changes in left atrial diameter (LAD), cardiac fibrosis,~     wall motion abnormalities and left ventricular function, changes in serum FGF 23 and soluble~     Klotho levels as well as changes in proBNP as well as pre- and postdialysis troponin T (TnT)~     levels will be determined. Additionally a quantitative analysis of the treatment influence on~     the individual metabolites of the renin-angiotensin-aldosterone system (RAAS) will be~     performed using mass spectrometry (RAAS fingerprint).~   "
29361|NCT03182686|"~     This is a phase 3 randomized study is to confirm the efficacy of an intra-articular injection~     of Ampion™ in adults with pain due to severe osteoarthritis of the knee.~      There will be a 7-day screening period for each subject followed by a 12-week participation~     period.~      The primary trial objective is to evaluate the clinical efficacy of Ampion using the~     OMERACT-OARSI (using the WOMAC 3.1 Index and PGA as assessments).~      The secondary trial objectives are to evaluate the safety of a single intra-articular~     injection (4 mL) of Ampion.~   "
29362|NCT03182673|"~     This aim of study to assess the safety and tolerability of SHR7390 combined with SHR-1210 and~     to define Dose limiting toxicity（DLT）and the maximum tolerated dose (MTD) of SHR7390 in the~     patients with advanced solid tumors.~      To evaluate the pharmacokinetics of SHR7390 in patients with advanced solid tumor.To assess~     the antitumor activity of SHR7390 combined with SHR-1210 in patients with advanced solid~     tumors preliminarily and recommend reasonable dosage regimen of SHR7390 for the follow-up~     clinical trial.~   "
29363|NCT03182647|"~     Anterior cruciate ligament (ACL) rupture is one of the most common sports-related knee~     injuries. Because it is such a significant injury - requiring a long period of rehabilitation~     before the injured person is ready to return to physical activity, the burden of injury is~     high. This can help to explain why so much of orthopaedic research is devoted to evaluating~     the outcomes of ACL injury. However, while there has been extensive study of short-term (up~     to 5 years after injury) outcomes, few studies have followed patients beyond 15 years after~     their ACL injury. This is important because long-term follow-up can provide key insights to~     guide the information provided to newly injured patients (e.g. to help set realistic~     expectations of what the injured person can expect of their knee function in the future), and~     help us evaluate the efficacy of previous treatments.~      The primary aim is to assess the influence of an acute ACL injury on knee function and~     quality of life, 32-37 years after the index injury. Approximately 300 patients injured~     between 1980 and 1985 will be invited to participate in the study. Patient- and~     clinician-reported outcomes, and radiographic osteoarthritis will be evaluated.~   "
29364|NCT03182634|"~     plasmaMATCH is a multi-centre phase IIa umbrella trial platform consisting of a ctDNA~     screening component and a therapeutic component. plasmaMATCH aims to assess whether ctDNA~     screening can be used to detect patients with targetable mutations, and will assess the~     safety and activity of the targeted treatments in patients with targetable mutations~     identified at ctDNA screening.~   "
29365|NCT03182621|"~     Despite recommends that school-based interventions use a comprehensive approach for health~     promotions; most fitness programs exclusively emphasize physical activity. This study~     compared the comprehensive Translational Health in Nutrition and Kinesiology (THINK) program~     to a traditional YMCA program (The Sports, Play, and Active Recreation for Kids (SPARK)~     fitness curriculum) on measures of physical fitness, body composition, and executive~     cognitive function outcomes among 105 ethnic minority children (9±1.03 years old) following a~     10-week intervention period.~   "
29366|NCT03182608|"~     Investigators assess the anatomic landmarks for spinal anesthesia in patients with hip~     fracture using ultrasonography.~   "
30764|NCT03164369|"~     The aim of this double blinded study is to assess the abilities of the SpineNav3DTM~     technology (Accuro) to identify the lumbar epidural space in parturients using as comparator~     a standar ultrasound (US) device.~   "
29370|NCT03182556|"~     Some authors claim that patients with musculoskeletal pain tend to underestimate their levels~     of muscle tension. The results of studies find evidences of the deficits in the perception of~     muscular tension in patients with chronic pain, being this the pathogenic factor in some~     musculoskeletal alterations. These studies show that patients with chronic pain can not~     identify their muscle tension and suggest that this contributes to maintaining pain. Thus,~     positive results have been found with relaxation and electromyographic biofeedback in~     patients with chronic pain. If these symptoms are due to excessive stress, patients should be~     able to benefit from regulation of muscle activity through BFB-EMG, thus learning to regulate~     the physiological variable. The study will be carried out in the electrotherapy laboratory of~     the Health Sciences Building of the University of Almeria. Initially, the sample will be~     chosen and the informed consent of the subjects will be obtained. Before the start of~     treatment, a baseline assessment of the dependent variables will be performed. Subsequently~     subjects will undergo three sessions of manipulative therapy over 12 weeks (one session per~     week). After the therapeutic intervention, a new determination of the dependent variables~     will be performed.~   "
29371|NCT03182543|"~     The aim of this study is to assess the antioxidant capacity of two mango base beverages (AM1,~     AM2), against exercise-induced oxidative stress.~   "
29372|NCT03182530|"~     Data from literature: transradial access failure sometimes occurs due to inability to~     cannulate the radial artery due to radial artery spasm1 causing severe difficulties in~     manipulation of the guide wires and catheters along the tortuous pathways of the arteries.~     both mechanical stimuli and circulating catecholamines through activation of~     α1-adrenoreceptors, causing smooth muscle cell contraction & radial artery spasm~   "
29373|NCT03182517|"~     Secondary hyperparathyroidism is an important complication in patient with chronic kidney~     disease . It is associated with bone complication and an increase in cardiovascular mortality~     The parathyroid hormone rises in these patients as consequence of low concentration of~     vitamin D3 ,reduction in quantities of serum calcium, phosphorus retention and reduction of~     vitamin D receptors sensitive to calcium.~   "
29374|NCT03182504|"~     The purpose of this study is to characterize the intrapulmonary penetration of nacubactam in~     healthy volunteers. Nacubactam is a novel non-beta-lactam beta-lactamase inhibitor being~     developed as a combination therapy with the beta-lactam meropenem for the treatment of~     serious gram-negative bacterial infections. Adult male and female healthy participants will~     receive a single intravenous infusion of nacubactam co-administered with meropenem and then~     undergo a bronchoalveolar lavage (BAL) procedure to collect lung epithelial lining fluid~     (ELF) for measurement of intrapulmonary concentrations of nacubactam and meropenem.~   "
29375|NCT03182491|"~     The purpose of this study is to explore different mechanisms for anaphylaxis and find novel~     biomarkers for this hypersensitivity syndrome. The study participants are patients with~     anaphylaxis, patients with mild allergic reactions, and patients with febrile transfusion~     reactions. The investigators will also include a group of healthy controls.~   "
29376|NCT03182478|"~     Skin Picking Disorder (SPD) affects 1.4-5.4% of the general population. It has a high~     association with anxiety and depressive symptoms. Only behavioral treatments demonstrated~     significant benefits compared with inactive control conditions, but with poor accessibility~     of this treatment to patients. Besides this, behavioral treatment does not address the~     associated anxious and depressive symptoms. Trichotillomania and SPD have co-occurrence rate~     greater than expected, indicating that can be part of the same disease spectrum. The Rothbaum~     Cognitive Behavioral Therapy(CBT) protocol is effective in treating trichotillomania. Based~     on the similarity of these diseases, this study uses the Rothbaum Protocol to treat SPD in~     individual and group format. We hypothesize that this protocol will be effective in treating~     SPD, anxiety and depression symptoms associated and also facilitate therapist training.~     Methods: A community sample of 40 participants with SPD will be randomly allocated to receive~     treatment with the Rothbaum Protocol individually or in group format. Patients with current~     psychotic disorder, suicide risk or mental disability will be excluded. Instruments measuring~     anxiety, depression and SPD severity will be applied in the baseline, after the intervention~     and after a 6 months follow-up. Motivation of patients to therapy will be evaluated at the~     baseline. The primary outcome will be the remission of symptoms evaluated by the overall~     clinical impression. The secondary outcomes will be the degree of improvement in anxiety,~     depression and SPD severity.~   "
29377|NCT03182465|"~     CALIF study is a monocentric observational study which aim is to analyse the value of adding~     procalcitonin (PCT, a pre-hormon increased in bacterial infection and septicaemia) in the~     management of chemo-induced febrile neutropenia occurring in patient with solid tumour.~     Febrile neutropenia will be managed according to international guidelines. PCT will be dosed~     at initial presentation. Primary objective is to determine the optimal value of PCT for the~     detection of septicaemia in low risk (according to MASCC score). The investigators plan also~     to compare two risk stratification scores: the validated MASCC score and a recently developed~     score which includes PCT and other more objective items.~   "
29378|NCT03182452|"~     This Clinical Study will be conducted as a comparative study focusing on usability and~     efficiency by comparing alarm burden pre- and post-implementation of an Alarm Advisor~     software.~   "
29379|NCT03182439|"~     The objective of this study is to evaluate the accuracy of four heart rate monitors in~     cardiac rehabilitation patients during typical, supervised cardiac rehabilitation involving~     exercise on a treadmill and/or stationary bicycle.~   "
29380|NCT03182426|"~     Type 1 diabetes is an autoimmune disease characterized by destruction of pancreatic~     beta-cells, resulting in absolute deficiency of insulin. Presently there is no known cure.~      Our proposed interventional trial is based on 'immunological reset' approach: T-depletion~     therapy and anti-inflammatory treatment will restore self-tolerance in T1DM; Autologous,~     peripheral-blood mobilized hematopoietic CD34+-enriched stem cells and a long-acting GLP-1~     analogue will promote pancreatic islet regeneration and repair.~      The short-term goals of this protocol is to demonstrate that subjects with new-onset T1DM~     undergoing autologous hematopoietic stem cell mobilization and immunologic reset will have~     greater preservation of endogenous insulin secretion compared to controls, and foremost that~     this nonmyeloablative treatment is safe, without the need for chronic immune suppression.~   "
29382|NCT03182400|"~     It is now widely accepted that autism is linked to a developmental disorder and cerebral~     function.~      Our research team (UMR U930 INSERM, François-Rabelais University of Tours, whom Pr F~     Bonnet-Brilhault is responsible for team Autism) hypothesizes that atypical sensory~     information processing, especially auditory and / or visual information, could underly the~     symptoms observed in autism. A better knowledge of the typical development of the sensory and~     cognitive processes must therefore make it possible in the long term to identify the~     abnormalities linked to the autism spectrum disorders (ASD).~      Studies in healthy subjects are therefore necessary in order to identify neurophysiological~     indices of cerebral functioning and to study their evolution during normal development,~     making it possible in the future to compare with populations of subjects with ASD.~      The investigators intend to study the development of all the cognitive processes involved in~     the processing of sensory and, in particular, auditory and visual information in humans: from~     low-level perception processes to higher-level cognitive processes (attention, emotion,~     language, prediction, ...). For this the investigators will use non-invasive~     neurophysiological explorations (EEG, eye tracking) as well as neuropsychological~     explorations (Questionnaires or spontaneous language recording).~      A better understanding of the pathophysiological mechanisms underlying the symptoms observed~     in autism could ultimately lead to the development of new specific therapeutic strategies,~     particularly in the field of exchange and development therapy or cognitive remediation .~   "
29383|NCT03182387|"~     To evaluate the diagnostic performance of amylase assay performed from bronchial alveolar~     fluid to differentiate aseptic chemical inhalation pneumonitis from an infectious inhalation~     pneumonitis in comatose patients with intubated ventilation for less than 24 hours.~   "
29384|NCT03182374|"~     This is a two-phase multicenter, double-blind, randomized, prospective evaluation of~     intra-articular injection(s) comparing APS to intra-articular HA injection(s). The maximum~     study duration for each subject will be 62 months; 60 months from treatment to last~     follow-up, and two additional months if the maximum visit window is realized. A total of 246~     patients will be enrolled. These patients will meet specific inclusion and exclusion~     criteria, but can be generally characterized as patients with painful unilateral knee OA who~     have been unable to achieve satisfactory pain relief with previous conservative OA treatment.~   "
29385|NCT03182361|"~     Patients with craniofacial defects caused by oncologic resection, traumatic events or~     congenital etiologies suffer from esthetic, functional and psychological problems. Auricular,~     nasal and orbital defects can be reconstructed with implant retained extra-oral prosthesis.~     The goal of this study is to evaluate implant survival in temporal, maxillary and orbital~     bone, and peri-implant tissue reactions using a new implant system developed by BioComp~     Industries.~   "
29386|NCT03182348|"~     Cardiovascular disease is the leading cause of illness and death in the world. The disease~     involves narrowing of blood vessels due to deposits of fat which can become coated in~     calcium. It is treated by percutaneous coronary intervention in which a balloon is passed~     down the blood vessel to remove the obstruction and where appropriate a stent is placed in~     the blood vessel to scaffold it.~      Early stage research suggests that the growth of small blood vessels in and around the~     deposits of fat and calcium leads to the growth of the deposit and may contribute to plaque~     rupture into the vessel leading to clot formation the process which leads to heart attacks.~     Drugs which prevent the development of these small blood vessel restrict the development of~     the deposit, and those that encourage the development of these small blood vessel also~     increase the development of the deposit. Researchers would like to find out more about the~     system of blood vessels around deposits of fat and calcium in the larger blood vessels. This~     involves looking just beneath the surface of the blood vessel wall, and requires a detailed~     and accurate image. Researchers on this project would like to find out if optical coherence~     tomography (OCT) is a suitable technique for imaging in this way.~      OCT works like an ultrasound, but using light instead of sound waves. The additional imaging~     will prolong the clinical procedure by 10-15 minutes.~   "
29387|NCT03182335|"~     To assess the impact of daily awakening from sedation on the amount of vasoactive medication~     required in the ICU. The hypothesis of this proposal is that the amount of vasoactive drug~     required to maintain an adequate mean arterial blood pressure will be reduced during a daily~     awakening from sedation.~   "
29388|NCT03182322|"~     Type 1 diabetes (T1D) results from an autoimmune destruction of the insulin-producing beta~     cells. Administration of mucosal insulin in islet autoantibody-negative children who are~     genetically predisposed for T1D offers the potential for inducing immunological tolerance to~     beta cells and thereby protect against the development of islet autoimmunity and T1D.~     Intranasal insulin has the advantage that whole protein will be exposed at the mucosa.~     Therefore, the available dose of insulin when administered intranasally is likely to be~     consistent between individuals. On this basis, the investigators aim to conduct a~     placebo-controlled, double-blind/double-masked primary intervention pilot trial (PINIT Study)~     of intranasal insulin treatment in islet autoantibody negative children to test immune~     efficacy and safety in the primary prevention setting. This pilot will help to develop and~     design a Phase III study aiming to test efficacy of preventing islet autoimmunity and T1D.~   "
29389|NCT03182309|"~     COPD and sleep apnea dyspnea syndrome represent two of the most common chronic lung diseases.~     It is reported that the prevalence of COPD with sleep apnea dyspnea syndrome is also very~     high. COPD and sleep apnea may have pathological or genetics interactions so that patients~     having both disorders tend to have worse outcomes than either condition alone. Data~     reflecting the prevalence, disease course and outcome of overlap syndrome is very limited in~     China. Therefore, the aim of the study is to describe the prevalence, treatment and outcome~     in Chinese patients and exploring the underlying interaction mechanism.~   "
29399|NCT03182179|"~     Patients will be randomized (1:1 ratio) to receive either 4 weeks of Ondansetron followed by~     4 weeks of placebo (O-P sequence) or 4 weeks of placebo followed by 4 weeks of Ondansetron~     (P-O sequence). It will be one week of washout between the two treatments.~      During the treatment questionnaires will be completed by the patients to evaluate the~     efficacy of the study treatment and the quality of live.~   "
29568|NCT03179969|"~     In approximately 10-15% of all patients after surgical or interventional heart valve~     replacement, flapping defects appear as complications in the long-term course, so-called~     paravalvular / paraprothetic leaks (PVL). In some patients, due to the severity of the~     defect, a new procedure is required - with a not inconsiderable disease or even mortality~     risk~   "
29390|NCT03182296|"~     In order to evaluate the difference in beta cell mass in women with and without a history of~     gestational diabetes mellitus (GDM), investigators aim to compare quantitative PET imaging of~     the pancreas between these groups. Investigators propose to measure uptake of~     68Ga-NODAGA-exendin-4 in the pancreatic beta cells of these women as a measure for beta cell~     mass. Furthermore, investigators aim to compare uptake of the radiolabeled tracer to beta~     cell function measured by laboratory parameters. These highly relevant data within this~     at-risk population for type 2 diabetes (T2D) will provide the investigators with more~     information on the role of beta cell mass in the predisposition for development of T2D~     leading to better knowledge on the pathophysiology of this disease. This could be of great~     interest for development of new treatment options.~   "
29391|NCT03182283|"~     Schizophrenia is a major mental illness that presents in young adulthood and affects ~1% of~     the population. Impact on affected persons life is often major and life expectancy is reduced~     by ~20 years. Better and more effective care models are needed to increase health in these~     persons. Person-centered care have been suggested to be one way to increase efficiency in~     care delivery for patients with chronical and complex conditions. The impact of~     person-centered care on a inpatient psychosis care setting is now being tested.~      The purpose of this study is to test whether inpatient Person-centered psychosis care (PCPC)~     can~        1. increase patient empowerment~        2. improve patient satisfaction~        3. reduce the frequency of involuntary treatments~        4. reduce the duration of inpatient care and~        5. reduce overall ward burden~      A further purpose is to qualitatively explore which components in this complex intervention~     are experienced as facilitators or barriers to the achievement of good care, from both~     patient, next-of-kin and staff perspectives.~      Quantitative data is collected through questionnaires from patients (measuring empowerment,~     care satisfaction and perceived health) before and after an educational intervention for~     staff, along with ward level measures such as care burden, number of involuntary treatments~     and length of stay on ward.~      Qualitative interview is used to study experiences of patients, next-of-kin and staff.~   "
29392|NCT03182270|"~     This study focuses on pancreatic cysts, especially malignant pancreatic cysts. The primary~     hypothesis of the study is that using nCLE in addition to EUS-FNA and tissue sampling allows~     better characterization of pancreatic cysts and improves appropriate therapeutic~     decision-making. For physicians, integrating nCLE into the diagnostic algorithm of pancreatic~     cysts could impact patient management by: Ruling out malignancy for patients with benign~     appearing nCLE images. Characterizing more malignant tumors in the pancreas.~   "
29393|NCT03182257|"~     This study will determine the safety and maximum tolerated dose of ONO-7579 in patients with~     advanced solid tumors, and evaluate efficacy of ONO-7579 in patients with advanced solid~     tumors harboring NTRK gene fusions.~   "
29394|NCT03182244|"~     The purpose of this study is to determine the clinical benefit of ASP2215 therapy in~     participants with FMS-like tyrosine kinase (FLT3) mutated AML who are refractory to or have~     relapsed after first-line AML therapy as shown with overall survival (OS) compared to salvage~     chemotherapy. In addition, this study will evaluate safety as well as determine the overall~     efficacy in event-free survival (EFS) and complete remission (CR) rate of ASP2215 compared to~     salvage chemotherapy.~   "
29395|NCT03182231|"~     In order to evaluate the difference in beta cell mass in morbidly obese patients with type 2~     diabetes mellitus (T2D) before and after Roux-en-Y gastric bypass (RYGB), investigators aim~     to compare quantitative PET imaging of the pancreas in this patient group before and after~     surgery. Investigators propose to measure the uptake of 68Ga-NODAGA-exendin-4 in the~     pancreatic beta cells of these patients. Furthermore, investigators aim to compare uptake of~     the radiolabeled tracer to beta cell function measured by laboratory parameters. These highly~     relevant data will provide investigators with more information on the contribution of the~     beta cells to the mechanisms behind resolution of T2D after bariatric surgery and on the~     prognostic value of pre-operative beta cell mass determination to T2D resolution. This might~     be of great interest for the assessment of RYGB as an alternative therapy in patients with~     T2D and a BMI <35, who currently do not meet the international guidelines for bariatric~     surgery.~   "
29396|NCT03182218|"~     Direct oral anticoagulants (DOAC) are a new drug group that has been approved for chronic~     anticoagulation of patients in atrial fibrillation or suffering acute thrombosis, between~     others. The need of surgery of a patient in atrial fibrillation is round 10% per year.~      Due to DOAC short time of commercialization and the lack of experience, the proper management~     of DOAC when a patient in this treatment needs a scheduled or urgent procedure, has not yet~     been established. This fact may mean both the decrease of the anticoagulant treatment~     efficacy and the increase of the haemorrhage complications in the perioperative period.~      With the aim of gaining additional information about this aspect, a multicentre, prospective~     and observational study (classified by the spanish drug society, AEMPS, as non-interventional~     trial, EPA-SP) about the DOAC management, before a scheduled or urgent surgery, in normal~     clinical practice, is proposed.~   "
29397|NCT03182205|"~     This study aims to evaluate the autonomic and hemodynamic responses triggered by inspiratory~     muscle exercise in prehypertensive and hypertensive individuals. The reason that leads us to~     this study refers to clinical relevance for individuals with high blood pressure levels,~     since this type of exercise can act as a important nonpharmacological agent for arterial~     pressure control. In addition, this study aims to elucidate the mechanisms involved in~     cardiovascular responses to inspiratory muscle exercise and, consequently, provide safety in~     the prescription of these for this population.~   "
29398|NCT03182192|"~     Hyperinsulinemic hypoglycemia (HH) is a rare complication that occurs 1 to 5 years after~     gastric bypass surgery. The underlying mechanism of this complication is not yet completely~     understood. Changes in hormone levels, such as GLP1 after RYGB, nesidioblastosis or an~     increase in the number of beta cells may be one of the underlying causes. However, several~     study results are conflicting and it is hypothesized that the patient population with HH~     after RYGB is heterogeneous and several underlying causes may be present. In order to~     differentiate between hyperfunction with normal beta cell mass and a general or localized~     increase in beta cell mass we aim to compare quantitative 68Ga-exendin-4 PET imaging of the~     pancreas between patients with and without HH after RYGB. Thereby, investigators aim to~     increase the insight in the underlying mechanism of HH after RYGB. If different underlying~     causes can be diagnosed, treatment for HH can be optimized for patients.~   "
29400|NCT03182166|"~     It is planned to enroll 80 UC patients who will require optimization of golimumab after~     secondary LOR. The review of the study protocol and its approval by an Independent Ethics~     Committee of the University of Saint Etienne are pending. All patients enrolled will give~     their written informed consent before being included. This study will be conducted in~     accordance with the ethical principles that have their origins in the Declaration of~     Helsinki, in compliance with the approved protocol, good clinical practice and applicable~     regulatory requirements. Patients will visit the investigator from screening visit to visit 6~     at W-1, W0, W2, W4, W8, and at the end of the follow-up at wk 24. During their participation,~     patients will record clinical parameters required to calculate the partial Mayo score~     reported over 3 days prior to the visit and endoscopy at W0, W2 (optional) , W4, W8~     (optional) and at the end of the follow-up to calculate total Mayo score.~   "
29401|NCT03182153|"~     Eligible subjects will wear 4 consecutive external monitoring devices for a total of 28 days~     of monitoring.~   "
29402|NCT03182140|"~     The main goal of this non-interventional study (NIS) is to evaluate user satisfaction with~     Kyleena in a real-life setting and to identify factors which influence user satisfaction,~     taking into account previously used contraceptive methods and reasons for use of Kyleena.~   "
29403|NCT03182127|"~     • Elbow pain is any type of pain that comes from structures in the elbow joint and/or in~     structures adjacent to the elbow joint. elbow is a complex joint; it allows to both extension~     and flexion, as well as rotation hand and forearm. Since most movements are a combination of~     these actions, Elbow pain is often caused by overuse, but in general, elbow joint is much~     less prone to wear-and-tear damage than are many other joints. The causes of elbow pain are~     numerous. Most elbow pain is due to overuse or strain on the elbow joint components, but some~     causes are due to trauma, infection, and/or autoimmune processes and neoplasm. Risk factors~     for elbow pain are numerous and range from engaging in repetitive activities and~     participation in sports to those associated with infection, trauma, and rheumatoid arthritis.~     Other adjacent structures associated with elbow pain include the shoulder, upper arm,~     forearm, and wrist and hand joints.~   "
29404|NCT03182114|"~     In this study, we will investigate the effect of left lateral tiling performed after spinal~     block on maternal hemodynamics compared to ordinary supine position~   "
29405|NCT03182101|"~     This project will test a measure of treatment quality, Exposure Guide, for therapists using~     exposure therapy for youths and young adults with anxiety or OCD. We anticipate that users of~     this measure will be able to complete it reliably, find it acceptable, and that the measure~     will predict patient outcome. This project will include 40 therapists treating 300 anxious~     youth and young adults ages 5-25 at a large community mental health agency. Results of this~     study will establish the Exposure Guide as a measure of exposure quality in real world~     settings.~   "
29406|NCT03182088|"~     three doses (0.05 mcg/Kg/min, 0.1 mcg/Kg/min, and 0.15 mcg/Kg/min) of norepinephrine will be~     compared for prophylaxis against Post-spinal anesthesia hypotension during Cesarean delivery.~   "
29407|NCT03182075|"~     Obsessive-Compulsive Disorder (OCD) is a chronic and disabling disorder that costs the~     economy over $2 billion annually and represents a significant public health problem. This~     study aims to build on our understanding of aberrant emotional processing in OCD. The~     proposed project tests whether a computerized training aimed to alter emotional processes,~     can relieve repetitive thoughts and behaviors.~   "
29408|NCT03182062|"~     The purpose of this study is to determine whether individualized ventilatory management~     during one-lung ventilation in patients scheduled for thoracic surgery, combining the use of~     low tidal volumes, alveolar recruitment maneuvers, individually titrated positive~     end-expiratory pressure and individually indicated ventilatory support will decrease~     postoperative pulmonary complications, ICU and hospital length of stay compared to a~     standardized Lung Protective Ventilation (LPV).~   "
29409|NCT03182049|"~     The ultimate goal of this prospective natural history study is to define the natural history~     of the obstructive airway manifestations of Granulomatosis with polyangiitis (GPA).~      Additionally this proposal seeks to develop biomarkers of disease activity and define their~     correlation with clinical outcomes in an effort to transform clinical care and shape future~     drug development for this devastating rare disease.~   "
29410|NCT03182036|"~     The main purpose of this study is to learn how patients breathe on portable oxygen~     concentrators (POCs), and to get feedback from patients using POCs.~   "
29411|NCT03182023|"~     Outcomes and Long-term Quality-of-life of Patients Treated With Extracorporeal Membrane~     Oxygenation are not known in china.A cross-section survey will be performed to assess the~     long-term outcome of these patients.~   "
29412|NCT03182010|"~     The aim of this randomized control trial is to compare the residual myometrial thickness and~     the depth of cesarean section scar defect after uterine incision closure with barbed or~     conventional sutures.~   "
29413|NCT03181997|"~     As for today, transcatheter aortic valve implantation (TAVI) is indicated only in symptomatic~     patients with severe aortic stenosis (AS) at high surgical risk. As cancer therapy improves,~     some AS patients suffering active malignancy (including advanced metastatic diseases) may be~     more endangered by their untreated valvular disease than their oncological disease. Among~     these patients, TAVI may be indicated before cancer related surgery or cardiotoxic~     anti-cancer therapy in order to achieve better anti-cancer therapy outcomes. Individualized~     life expectancy assumptions should be evaluated by the heart team in the clinical~     decision-making process as an essential factor in weighing the risk-benefit ratio for~     oncologic patients undergoing TAVI. A multicenter, international TAVI in Oncology Patients~     with AS (TOP-AS) registry was designed to collect data on patients with an active malignancy~     and severe AS undergoing TAVI. The aim of the study is to evaluate the outcomes, benefits and~     risks of oncology patients undergoing TAVI, mainly the patients' survival and cause of death~     and also the interactions between the valvular and the oncologic conditions.~   "
29414|NCT03181984|"~     This study is to provide safety information of hemoporfin during the post-marketing period as~     required by China Food and Drug Administration (CFDA) regulations in order to identify any~     potential drug related treatment factors in the Chinese population, such as~     unknown/unexpected adverse reactions, the incidence of adverse reactions under the routine~     drug uses.~   "
29582|NCT03179787|"~     The purpose of this study is to evaluate the safety and effectiveness of aripiprazole in~     patients with autism in the real world clinical setting in Japan.~   "
29415|NCT03181971|"~     It is widely argued that the promotion of water consumption, as an alternative to~     sugar-sweetened beverages, can assist in childhood obesity prevention efforts. Yet no studies~     have tested this argument in real world schools where flavored milk or juices are available.~     This trial will fill gaps by examining how promoting fresh water intake-both in schools that~     do and do not provide access to caloric beverages -impacts children's consumption of food and~     beverages both during and outside of school, and obesity.~   "
29416|NCT03181958|"~     Respiratory distress syndrome (RDS) is the main cause of respiratory failure in preterm~     neonates, its incidence varying from 80% to 25% depending on gestational age.When optimal~     prenatal care is provided, the best approach to treat RDS, according to several recent~     trials,consists in providing continuous positive airway pressure (CPAP) from the first~     minutes of life using short binasal prongs or masks, followed by early selective surfactant~     administration for babies with worsening oxygenation and/or increasing work of breathing. Any~     effort should be done to minimize the time under invasive mechanical ventilation~     (IMV).Nonetheless, clinical trials have shown that a relevant proportion of preterm neonates~     fails this approach and eventually need IMV.The duration of IMV is a well known risk factor~     for the development of broncho-pulmonary dysplasia (BPD) - a condition associated with~     significant morbidity and mortality.~      To minimize the duration of IMV, various non invasive respiratory support modalities are~     available in neonatal intensive care units (NICU). CPAP is presently the most common~     technique used in this regard. However, a systematic review has shown that non-invasive~     positive pressure ventilation (NIPPV) reduces the need for IMV (within one week from~     extubation) more effectively than NCPAP, although it is not clear if NIPPV may reduce need~     for intubation longterm and it seems to have no effect on BPD and mortality. NIPPV main~     drawback is the lack of synchronization, which is difficult to be accurately achieved and is~     usually unavailable. A more recent alternative technique is non-invasive high frequency~     oscillatory ventilation (NHFOV) which consists on the application of a bias flow generating a~     continuous distending positive pressure with oscillations superimposed on spontaneous tidal~     breathing with no need for synchronization. The physiological, biological and clinical~     details about NHFOV have been described elsewhere.~      To date, there is only one small observational uncontrolled study about the use of NHFOV~     after extubation in preterm infants. Other relatively small case series or retrospective~     cohort studies suggested safety, feasibility and possible usefulness of NHFOV and have been~     reviewed elsewhere.The only randomized trial published so far compared NHFOV to biphasic~     CPAP,in babies failing CPAP and it has been criticized for methodological flaws and for not~     taking into account respiratory physiology.An European survey showed that, despite the~     absence of large randomized clinical trials, NHFOV is quite widely used, at least in some~     Countries and no major side effects are reported, although large data about NHFOV safety are~     lacking. This may be due to the relative NHFOV easiness of use but evidence-based and~     physiology-driven data are warranted about this technique.~   "
29417|NCT03181945|"~     There are no guidelines or studies evaluating duration of anti-epileptic drugs in central~     nervous system infections. The duration of anti-epileptic drug is extrapolated from traumatic~     brain injury in which duration of 1 weeks to 3 months is suggested. So the investigators plan~     to conduct this study to decide the optimal duration of anti-epileptic drug in acute~     symptomatic seizure in central nervous system infections~   "
29418|NCT03181932|"~     This study is a multi-center, randomized phase III study to evaluate the clinical~     effectiveness of AeroVanc in persistent MRSA in patients with Cystic Fibrosis.~   "
29419|NCT03181919|"~     the aim of the study is to compare between the step-up and conventional protocols in~     ovulation induction in infertile women with PCOS~   "
29420|NCT03181906|"~     This study evaluates the the effectiveness of pre-consultation Medication Reconciliation~     Service in reducing unintentional medication discrepancies among patients who discharged from~     hospital to primary care.~   "
29421|NCT03181893|"~     A Study looking at Investigational drug and Placebo administered to adult Patients with~     moderate to severe Dermatomyositis~   "
29422|NCT03181880|"~     ASTUTE is a pragmatic open randomised 12-week multinational trial to evaluate the~     effectiveness of aclidinium bromide/formoterol fumarate dihydrate fixed-dose combination~     compared to standard of care bronchodilators in chronic obstructive pulmonary disease.~   "
29423|NCT03181867|"~     Background:~      Prostate cancer is the second leading cause of cancer deaths in American men. When prostate~     cancer is confined to the prostate there is a high chance of cure. However, it is outside the~     prostate or comes back after treatment, additional therapy may be needed. Current methods of~     imaging prostate cancer are limited. Researchers want to see if a radiotracer called~     18F-DCFPyL can identify prostate cancer in patients who have a high risk of cancer spreading~     outside the prostate or who have signs of recurrent cancer after treatment.~      Objectives:~      To see if the radiotracer 18F-DCFyL can help identify prostate cancer in the body before or~     after therapy.~      Eligibility:~      Men ages 18 and older who have prostate cancer that has been newly diagnosed, or has relapsed~     after radiation or surgery~      Design:~      Participants will be screened with medical history and physical exam. They will have blood~     taken.~      Participants will be divided into 2 groups.~        -  Group 1 will be men with cancer that has been newly diagnosed as high risk by their~          doctor who are scheduled to have prostate removal surgery or undergo biopsy before~          radiation therapy.~        -  Group 2 will be men who have presumed prostate cancer relapse after prostate removal~          surgery or radiation therapy.~      Both groups will have scans taken. Participants will lie still on a table in a machine that~     takes pictures of their body. 18F-DCFyL will be injected by intravenous (IV) line.~      Participants will be contacted for follow-up after scans.~      Participants in Group 1 may have surgery to remove their prostate gland or a biopsy to remove~     some prostate tissue. This procedure will be standard of care and is not a part of this~     study. They will also have an extra MRI scan of their prostate. For this, a tube, called an~     endorectal coil, will be placed in their rectum. Other tubes may be wrapped around the inside~     of their pelvis. A contrast agent will be given by IV.~      Participants in Group 2 may also undergo an MRI of the pelvis and may have a biopsy of~     abnormalities found on the 18F-DCFyL scan.~      Participants will have data about their prostate cancer collected for up to 1 year.~   "
29424|NCT03181854|"~     This study verifies whether integrated Early Palliative Care for advanced cancer patients~     diagnosed due to a solid tumor improve quality of life and enhances the ability to overcome~     the current crisis.~   "
29425|NCT03181841|"~     Numerous psychiatric and neurodegenerative diseases like schizophrenia, dependency on drugs~     of abuse, depression and Parkinson's disease are related to motivational and cognitive~     deficits in value-based decision making, which frequently persist even after a successful~     pharmacological treatment. According to current neurobiologic models, cortical dopamine D1~     receptors play a crucial role in taking value-based decisions. In this study, it will be~     investigated whether value-based decisions in healthy volunteers can be improved by~     stimulation of D1-receptors. For this purpose, a newly developed dopamine D1-agonist will be~     used, which selectively increases the activities of frontal D1- and D5-receptors. In this~     double-blind, randomized, placebo-controlled study, the effects of different single doses of~     PF-06412562, a not yet licensed D1-agonist, on value-based decision making will be compared~     with placebo. The use of different dosage strengths will allow to investigate a potential~     relationship between the extent of activity of the D1-receptor and its influence on~     behavioral indices.~      Therefore, four parallel groups will be investigated. Each participant takes in a single dose~     of either PF-06412562 in different doses or placebo. A screening exam will be carried out 1-3~     weeks before the drug intake, and a follow-up examination will be carried out approx. 1 week~     after the drug intake. At all 3 visits in the study centre, several tests for the~     investigation of value-based decision making will be carried out.~   "
29426|NCT03181828|"~     The objective is to determine if acetohydroxamic acid (AHA) can prevent hydrolysis of urea by~     inhibiting the bacterial urease of gut flora of both healthy control adults as well as adults~     with urea cycle disorders~   "
29427|NCT03181815|"~     The vast majority of patients with AML will die of the disease, and no standard chemotherapy~     regimen were defined for patients with relapsed/refractory AML. Previous studies have~     confirmed the efficacy of cladribine in the treatment of AML, both de novo or~     relapse/refractory AML. Our previous experience has shown that Cladribine in combination of~     CAG (G-CSF priming, low dose cytarabine, and aclarubicin) are effective with tolerable~     toxicity profiling.Thus, this phase 2 clincial trial is going to evaluate the efficacy and~     safety of cladribine in combination with G-CSF, low-dose cytarabine and aclarubicin (C-CAG)~     in patients with refractory/relapsed acute myeloid leukemia.~   "
29428|NCT03181802|"~     Studying the therapeutic effect of paravertebral injections of BoNT-A (botulinum toxin A)~     requires further studies to confirm the reported short-term therapeutic effect and to~     determine potential predictive factors of efficacy.~   "
29429|NCT03181789|"~     The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of two~     HIV-1 pDNA vaccines: p24CE1/2 pDNA and p55^gag pDNA administered with IL-12 pDNA adjuvant,~     given by intramuscular (IM) injection with electroporation (EP), in healthy, HIV-uninfected~     adults.~   "
29430|NCT03181776|"~     The aim of this work is to investigate the effect of different angles of lateral tilt on the~     maternal hemodynamics before and after subarachnoid block~   "
30830|NCT03163511|"~     The purpose of this trial is to test if VC-02™ combination product can be implanted~     subcutaneously in subjects with Type 1 Diabetes and Hypoglycemia Unawareness and maintained~     safely for up to two years. It will also test if VC-02 is an effective treatment for these~     subjects.~   "
29431|NCT03181763|"~     This study will examine how the drug methylenedioxymethamphetamine (MDMA) impacts response to~     different types of memory in humans compared to placebo. MDMA is an experimental drug and is~     illegal to possess outside of research; when sold illegally it is referred to as Ecstasy or~     Molly (material supposedly containing MDMA). MDMA may make it easier to face unpleasant~     memories and reduce anxiety, and it may do so in part by influencing response to memories.~     This study will enroll healthy adults who will need to come in for three visits over four~     days. At visit 1, participants will undergo a 1-hour startle test. The startle test measures~     eye-blink response to loud sounds. After this, the participant will also view different~     colored shapes presented on a computer monitor. While watching the computer monitor, the~     participant will experience several brief blasts of air directed at the throat, while~     eye-blink is measured with sensors under the eye. The following day at visit 2, participants~     will be randomized to receive placebo or 100 mg MDMA and will complete tasks similar to the~     ones completed the previous day. The researchers will measure pulse, blood pressure and~     temperature once before and seven times after receiving MDMA or placebo, and study~     participants will complete a questionnaire about their experience. Two days after receiving~     MDMA or placebo, participants will return for a third visit to complete similar tasks to~     previous visits. This study will also measure sleep through a sleep diary and actigraphy,~     which is a device worn on the wrist like a watch that records movement during sleep and lets~     researchers see how much sleep a person is getting.~   "
29432|NCT03181750|"~     Palliative care is a priority area of focus for the National Institute of Nursing Research.~     Despite the evidence-based benefits of palliative care, access remains limited, especially in~     poor urban and rural settings. Cultural and linguistic barriers may also increase disparities~     in palliative care for Latinos. Due to a nationwide shortage of palliative care providers and~     the unique cultural preferences and values of patients, our innovative study has the~     potential to improve palliative care outcomes and reduce health disparities in both urban and~     rural underserved communities.~   "
29433|NCT03181737|"~     The trial aim of the study is to evaluate the effectiveness of a novel psychological internet~     intervention (Covivio), which was designed to improve adherence in Persons with Diabetes~     Mellitus type 2 (PwDM), using cognitive-behavioral therapy (CBT) techniques. Therefore, 300~     PwDM will be recruited and randomized to three groups:~      (1) a treatment group that immediately receives two-month access to Covivio and may also use~     care-as-usual (CAU), (2) an active control group that also immediately receives a two-month~     access to Relaxio, an internet program with the focus of stress relaxation ,and may also~     additionally use CAU or (3) a control group, in which they may engage with any diabetes~     treatment (i.e. CAU/ wait list control group). The active control group (2) and the wait~     control group (3) receive access to Covivio after a delay of six months. The primary outcome~     measure is the Diabetes Self-Management Questionnaire-Revised (DSMQ-R), collected at~     baseline, two (post-treatment), and additionally three and six months follow-up.~   "
29434|NCT03181724|"~     The investigators plan a prospective randomized controlled study that compares whether the~     use of a decision aid results in different scores on variables reflective of the~     decision-making process, behavior, health outcomes, communication, and healthcare system.~   "
29435|NCT03181711|"~     BACKGROUND: To diagnose caries in clinical practice today, a combination of clinical~     examination with mirror and probe, and in sometimes x-ray images are used. For surfaces in~     contact with other teeth X-rays (preferably bitewing) are often required. Even though the~     radiation doses in bitewings are small, it is important to weigh risks against the benefit to~     avoid unnecessary radiation.~      There are other methods for diagnosing caries based on different forms of laser light. One~     such technique is based on the translucency of the teeth. The light is within the near~     infrared light (NIR) area. A product named DAIGNOcam (diagnostic camera) is using this~     technology. The light is led in a hand piece held against the tooth. The tooth is illuminated~     and the caries lesions can be seen like dark spots on a computer monitor screen. The~     technique is mainly used in adult patients and permanent teeth. However, there is no complete~     evaluation of how well the technology diagnoses caries in milk teeth. From a radiation~     hygiene point of view, it is particularly important to reduce the amount of X-rays to young~     individuals. X-rays are often experienced as difficult by younger children, which leads to~     poorer diagnostics. It is important to identify early caries in milk teeth as these teeth~     have thinner enamel and a more porous dentin. This may lead to that caries progress much~     faster thus more difficult to fix. This in turn leads to a risk of toothache and that the~     damage becomes so extensive that the tooth must be removed.~      OBJECTIVE: To investigate diagnostic accuracy / precision in caries diagnosis between teeth~     using DIAGNOcam in milk teeth comparable to caries diagnostics using bitewing x-rays.~      RESEARCH QUESTIONS:~        -  Is DIAGNOcam a reliable diagnostic method for diagnosing caries in between teeth~          (approximal caries) in milk teeth?~        -  How does child experience caries diagnosing performed with DIAGNOcam compared to X-rays?~          INVESTIGATION VARIABLES: Caries data are recorded according to the accepted diagnostic~          method at the surface level. Each examined tooth surface is assessed as either 1)~          intact; 2) caries only in enamel; 3) caries i dentin; or 4) the surface can not be~          judged. The same classification is used for X-rays and DIAGNOcam.~      The children will also be able to rate their experience of the X-ray examination and the~     DIAGNOcam survey using a Faces pain scale to see if there is any difference in experience~     between the different methods of investigation.~   "
29436|NCT03181698|"~     Bipolar disorder is a complex psychiatric disorder characterized by recurrent episodes of~     mania or hypomania and depression, and affects around one to three percent of the population~     . Bipolar Disorder is associated with significant psychosocial morbidity and mortality , and~     is among the leading causes of disability worldwide . The disease is highly heritable, but~     the underlying pathophysiology is not yet understood .~   "
29437|NCT03181685|"~     This randomized, controlled, prospective, crossover, open-label, two-treatments, two-period~     trial aimed to evaluate the preference expressed by the patient concerning the subcutaneous~     administration of progesterone versus the vaginal one.~      The couples, scheduled for performing 2 In Vitro Fertilization (IVF)/Intracytoplasmic Sperm~     Injection (ICSI) cycles will be randomized to receive, as luteal phase supplementation,~     Pleyris 25 milligram (mg) (a single subcutaneous administration per day) or Prometrium 200 mg~     (3 vaginal administrations per day).~   "
29438|NCT03181672|"~     To investigate the influence of stellate ganglion block on tourniquet response during surgery~     in patients undergoing elective lower limb Department of orthopedics.~   "
29439|NCT03181659|"~     This clinical trial study evaluates the effectiveness of a multimodal physiotherapy treatment~     based on a biobehavioural paradigm in the treatment of non-specific chronic low back pain.~     The experimental group received treatment based on therapeutic exercise, education in~     neuroscience, and manual therapy, contrary to the control group, which did not receive manual~     therapy treatment.~   "
29583|NCT03179774|"~     Revascularization for carotid artery occlusion (CAO) remained controversial, there is no~     prospective randomized control trial (RCT) regarding carotid artery stenting (CAS) in CAO~     patients. The investigators conduct a prospective study composed of clinical registry arm and~     RCT arm. The main purpose of the study is investigate neurocognitive function at 3 months and~     thereafter up to 12 months.~   "
29440|NCT03181646|"~     Citicoline, is a naturally occurring compound and an intermediate in the metabolism of~     phosphatidylcholine. Phosphatidylcholine is an important component of the phospholipids of~     the cell membranes. Citicoline is composed of two molecules: cyti¬dine and choline. Both~     these molecules enter the brain separately and by passing through the blood-brain barrier~     where they act as substrates for intracellular synthesis of CDP-choline . This drug has been~     widely used in adults who suffer from acute ischemic strokes for than 4 decades with good~     results and has been proved to have a very good safety profile as well. It has various~     therapeutic effects at several stages of the ischemic cascade in acute ischemic stroke.~        1. It stabilizes cell membranes by increasing phosphatidylcholine and sphingomyelin~          synthesis and by inhibiting the release of free fatty acids . By protecting membranes,~          citicoline inhibits glutamate release during ischemia. In an experimental model of~          ischemia in the rat, citicoline treatment decreased glutamate levels and stroke size.~        2. Citicoline favors the synthesis of nucleic acids, proteins, acetylcholine and other~          neurotransmitters, and decreases free radical formation Therefore, citicoline~          simultaneously inhibits different steps of the ischemic cascade protecting the injured~          tissue against early and delayed mechanisms responsible for ischemic brain injury.~        3. citicoline may facilitate recovery by enhancing synaptic outgrowth and increased~          neuroplasticity with decrease of neurologic deficits and improvement of behavioral~          performance.~      Considering these pharmacologic properties of citicoline, we are planning to see its effects~     in newborns who have HIE which causes a global acute ischemic changes in developing brain.~   "
29441|NCT03181633|"~     The purpose of this study is to evaluate long term safety and efficacy of ACH-0144471 in~     patients with PNH who have demonstrated clinical benefit from ACH-0144471 in Clinical Study~     ACH471-100. This study is designed to include up to 12 patients.~   "
29442|NCT03181620|"~     SATIRE is a prospective, randomized control trial assessing two methods of administration of~     intravenous sedation and narcotics in surgical patients requiring mechanical ventilation.~     Many hospitals use a continuous infusion method of administering these medications. The~     investigators hypothesize that intermittent, bolus/sliding-scale based administration will~     lead to less medication being given and subsequently decrease the amount of time on~     mechanical ventilation without compromising patient comfort or level of sedation.~      Patients are randomized into a control arm (continuous infusion) and a trial arm (sliding~     scale hourly bolus) using versed for sedation and fentanyl for pain medication. Inclusion~     criteria are surgical patients requiring mechanical ventilation, including trauma patients,~     post operative patients, etc.~      Primary end point is total time of mechanical ventilation in each arm. Secondary end points~     are amount of medication given, time in ICU, time to discharge. Mortality and adverse events~     in both arms are recorded and reported to the Institutional Review Board for monitoring.~   "
29443|NCT03181607|"~     Mother-to-Child-Transmission (MTCT) of HBV is the most important route in high endemic~     countries. Although active-passive immune prophylaxis is generally administrated to infants~     delivered by HBsAg positive women, there are a lot of people infected with HBV in China. High~     HBV DNA load (>10^5IU/ml) is the vital cause of MTCT. So some researchers used TDF~     （tenofovir） or LDT（telbivudine） to treat patients with high HBV DNA load during middle, late~     pregnancy, in order to decrease MTCT. As a result, some data about it were gradually reported~     in late years. Recently, American Association for the Study of Liver Diseases, European~     Association for the Study of Liver Diseases and China guidelines for CHB (chronic hepatitis~     B) suggest that pregnant women with high HBV DNA load be treated with TDF or LDT at 24-28~     weeks of gestation to lower MTCT of HBV.~      Although TDF or LDT is classified as pregnancy B drugs by FDA, and many studies report that~     MTCT rate of HBV decreases after women with high HBV DNA load are administrated with TDF or~     LDT at 24-28 weeks of gestation, a few birth defects are reported. Furthermore, the~     long-effect of TDF or LDT on infants remains unclear thoroughly.~      Some CHB women had severe liver dysfunction before pregnancy or during pregnancy, and routine~     liver protection therapy could not effect. Some of them could develop into liver failure,~     fibrosis, cirrhosis, and even died. Moreover, severe liver dysfunction often leads to adverse~     effects to pregnant women and fetuses, such as pregnancy failure, lower weight, premature~     birth, etc. As a result, these women have to accept TDF or LDT before pregnancy, or during~     early pregnancy. So the long-effect of TDF or LDT on infants needs thoroughly investigating.~      Taken together, the investigators will enroll women with chronic HBV infection and evaluate~     their state of illness. Then the investigators treat participants with TDF or LDT or routine~     liver protection therapy, and follow up the participants for a long period. The~     investigators' objectives are as follows:~      A, To clarify efficacy and adverse effects of TDF/LDT in preventing MTCT between~     immune-tolerant and immune-active CHB patients.~      B, To clarify efficacy and adverse effects of TDF/LDT in preventing MTCT during different~     trimesters of pregnancy.~      C, To compare MTCT rate between patients received TDF/LDT therapy and patients without~     TDF/LDT therapy.~      D, To compare MTCT rate and adverse effects between LDT and TDF.~   "
29444|NCT03181594|"~     A multi-center, prospective, non-randomized, interventional clinical trial to assess the~     safety and effectiveness of the ClariFix™ device when used to ablate unwanted tissue in the~     nose of subjects with chronic rhinitis.~   "
29445|NCT03181581|"~     Tools for improving brain tumor surgery, in particular for gliomas, are increasing. There~     seems to be an agreement that achieving extensive resections, when done safely without~     jeopardizing neurological function, improves survival.~      Ultrasound is currently used as a tool for providing 2D or 3D images for tumor localization~     and resection control. For the use in resection control the resection cavity is filled with~     saline to provide acoustic coupling between the ultrasound transducer and tissue. However,~     attenuation of acoustic waves is very low in saline compared to the brain and this difference~     in attenuation is the cause of artifacts that may severely degrade the ultrasound images.~     Such artifacts are seen as high-intensity signal at the resection cavity wall and beyond. The~     artificial signal enhancement can potentially mask small tumor remnants and is generally~     making the interpretation of images more difficult.~      This research group has developed an acoustic coupling fluid intended for use in the~     resection cavity instead of saline. Tests in laboratory measurements have shown that the~     fluid reduces artifacts and has the potential to enhance ultrasound image quality in brain~     tumor surgery. Three different concentrations of the acoustic coupling fluid have been tested~     in a phase 1 study that included 15 patients with glioblastoma. The concentration that~     provided the optimal ultrasound images, from qualitative and quantitative inspection, is used~     in the current phase II study. This study is a randomized controlled trial aiming to include~     82 patients with glial brain tumours. Its purpose is to test the fluid during surgery of~     glial brain tumours to further investigate safety and efficacy.~   "
29446|NCT03181568|"~     12-week single-blind, prospective, randomized, controlled, pilot clinical trial assessing The~     MolecuLight i:X Imaging Device in chronic wounds. This device guides clinicians to inspect,~     sample, debride or further evaluate areas within or around a wound where potentially harmful~     bacteria appear under violet light illumination resulting in better overall care and~     accelerated surface area reduction compared to current standard care. The study aims to~     determine if this device aids in the healing of chronic wounds by reduction in size of wound~     compared to current standard of care.~   "
29447|NCT03181555|"~     1. Determine if the stool or vaginal microbiome and urinary metabolite profiles in a~          pregnant obese population of African American women differ from their pregnant non-obese~          counterparts~        2. Determine if the stool or vaginal microbiome and urinary metabolite profiles vary by~          class of obesity and magnitude of excess weight gain in this population of pregnant~          African-American women.~        3. Assess the ability of the stool, vaginal microbiome, or metabolites, or the combination~          of all biomarkers as predictors of preterm birth (PTB) and onset of labor.~        4. Determine if any dietary or clinical variables are correlated with changes in the~          microbiome or urinary metabolites or modify their association with PTB~   "
29448|NCT03181542|"~     The objective of the study is to assess the efficacy of the vein visualization device~     AccuVein (AccuVein, Inc., Huntington, NY) in comparison to a standard technique for~     establishing intravenous (iv) access in the infant and toddler population (<2years)~   "
29449|NCT03181529|"~     The proposed pilot study will assess whether people with major depressive disorder experience~     psychological and behavioral benefits and/or harms from psilocybin. This study will~     investigate acute and persisting effects of psilocybin on depressive symptoms and other~     moods, attitudes, and behaviors. The primary hypothesis is that psilocybin will lead to rapid~     and sustained antidepressant response, as measured with standard depression rating scales.~   "
29450|NCT03181516|"~     Probiotics are live microorganisms that, when administered in adequate amounts, confer a~     health benefit on the host. One of the most common indications for probiotic treatment is the~     prevention of antibiotic-associated diarrhea (AAD). Unfortunately, many probiotic products~     used for AAD are not supported by rigorous independent research, and often results in~     non-evidence-based usage. The overarching objective is to move research forward for the most~     well-studied Bifidobacterium strain. The primary aim is to test the efficacy of high dose,~     BB-12-supplemented yogurt in preventing AAD, compared to yogurt without BB-12, in children~     receiving antibiotics. Other aims are to further assess the safety of yogurt supplemented~     with BB-12, and to carry out longitudinal community structure and gene expression analysis of~     fecal microbiota to evaluate the impact of high dose BB-12 in a pediatric population~     receiving antibiotics. The microbiota includes hundreds of species, and its disruption is~     hypothesized to be an important factor in the development of AAD.~   "
29451|NCT03181503|"~     This is a randomized, placebo-controlled, double-blinded, parallel group, multicenter study~     to evaluate the safety and efficacy of nemolizumab over a 12-week treatment period in~     patients suffering from PN compared to its placebo.~   "
29452|NCT03181490|"~     Current state-of-the-art lung cancer early screening utilizes low-dose CT scan to identify~     lung nodules smaller than 3 cm in diameter. However, it's still a clinical challenge to~     differentiate between malignant and benign nodules.~      In previous studies, we had taken the approach of methylation profiling by high throughput~     bisulfite DNA sequencing in tissue samples to identify specific methylation signatures. We~     had learned methylation patterns that differentiate malignant vs. benign lesions from tissue~     samples by in-depth data mining, and then used pattern matching to classify plasma samples.~      In this study, we are going to validate the efficacy of ctDNA methylation test for diagnosing~     early lung cancer by comparing results of the pre-surgery ctDNA methylation test with the~     post-surgery pathology.~   "
29453|NCT03181477|"~     Glioblastoma (GBM) is the most aggressive and most frequent brain tumour. Approximately four~     people per 100,000 inhabitants are diagnosed with this disease every year. The standard~     treatment comprises surgical resection (whenever possible), normofractionated radiotherapy at~     a dose of 60Gray (Gy) and temozolomide (TMZ). Median overall survival in these patients is~     14.6 months [13.2-16.8].~      In a previous phase I clinical trial, dose escalation tolerance using simultaneous-integrated~     boost intensity-modulated radiation therapy (SIB-IMRT) technic has been evaluated. The~     investigator demonstrated that SIB-IMRT until a dose of 80Gy in 32 daily fractions,~     associated with TMZ is feasible and well tolerated by patients with glioblastoma.~      The aim of this present phase II clinical trial is to evaluate the overall survival at 18~     months for patients with glioblastoma receiving TMZ, according to standard protocol,~     associated to radiotherapy delivered at 80Gy using SIB-IMRT technic. The first planning~     target volume (PTV), including oedema and tumour highlighted on T2 flair magnetic resonance~     imaging (MRI) sequences, will receive 60.8Gy in 32 daily fractions. The second PTV, including~     tumour highlighted on T1 MRI sequences, will receive 80.0Gy in 32 daily fractions.~      Secondary objectives are tolerance, survival free progression and quality of live~     evaluations.~      Sixty seven patients will be enrolled in this present trial.~   "
29454|NCT03181464|"~     During labor and delivery, pregnant women may choose to receive pain relief called epidural~     analgesia, which is the delivery of a numbing agent through the back and into a body space~     around the spinal column. This numbs the area of the stomach and the pelvis. Typically the~     numbing agent is lidocaine, which is a local anesthetic like your dentist uses. Some times~     the numbing agent is combined with another medication that causes drowsiness and relieves~     pain called a narcotic. One of the risks associated with having this kind of pain relief is~     unintentional puncture of a sheath of tissue that surrounds and protects the spinal cord when~     inserting the needle. This sheath is called the dura. This would cause the fluid surrounding~     the spinal cord to leak out and this would cause a headache. This headache is called a~     post-dural puncture headache [PDPH]. The headache can be mild or severe. Rarely, PDPH can be~     serious and cause bleeding or small clots in the brain and damage to nerves that come out of~     the brain.~      The purpose of this study is to test the use of a technique that uses a hollow cotton swab~     [no needles] to numb a nerve cell cluster that sits at the very back of the nasal cavity. The~     anatomical name for this nerve cell cluster is the sphenopalatine ganglion. This has been~     done before at BJH and other hospitals with positive results, but no formal studies have been~     conducted here. Also, the sphenopalatine ganglion [SPG] has been the treatment target for~     other kinds of headaches. To numb the SPG, a hollow tip cotton swab [like a long Q-Tip] is~     inserted through the nose to the back of the nasal cavity and a solution of numbing agent is~     slowly pumped through the hollow Q-tip. This study will include a group that will receive a~     salt solution through the swab instead of a numbing agent. Subjects will be offered BJH~     standard care for their headache if they do not have relief from the study procedures.~     Standard care would be decided by their treating physician and may include oral pain~     medications and/or medications like ibuprofen [Motrin] or they could have a procedure called~     an epidural blood patch. This is performed by injecting a small amount of the patient's own~     blood into the areas of the spinal column where the original epidural anesthesia was injected~     in order to patch the leaks in the dura.~   "
29455|NCT03181451|"~     The study has been designed to establish the pharmacokinetics (PK) and iron uptake of Ferric~     Maltol in children and adolescents aged 10-17 years using two (2) lower dose strengths in~     comparison to the EU-approved 30mg BID dose in adults with IDA in IBD.~   "
29608|NCT03179449|"~     This pilot early phase I trial studies how well ferumoxytol-enhanced magnetic resonance~     imaging (MRI) correlates with inflammatory (macrophage) responses in pediatric patients with~     malignant brain tumors. If there is good correlation, ferumoxytol-enhanced MRI can serve as a~     noninvasive imaging biomarker of inflammation.~   "
29456|NCT03181438|"~     The objective of this study is to evaluate the efficacy and safety of transverse abdominal~     plane block in patients undergoing renal transplant surgery.Adult renal transplant recipients~     will be prospectively randomized to receive a standard general anesthetic technique~     supplemented with ropivacaine 0.375% 20 mL TAP block or sham block with 20 mL 0.9% saline.~     Both groups will receive patient-controlled morphine analgesia. Patient assessment will occur~     in the postanesthetic care unit and at 1, 2, 4, 6, 12, and 24 hours. The primary outcome is~     total morphine consumption in the first 24 hours after renal transplantation. Other outcomes~     asses include pain scores, presence of nausea or vomiting, excessive sedation, and~     respiratory depression.~   "
29457|NCT03181425|"~     The aim of this study is the evaluation of new MRI tractography maps for early knee~     osteoarthritis assessment.~   "
29458|NCT03181412|"~     The effectiveness of acute ischemic stroke (AIS) management has improved considerably in~     recent years with thrombolysis and more recently with mechanical thrombectomy (MT).~     Currently, mechanical thrombectomy can only be performed in stroke unit with an~     interventional neuroradiology center by experienced/qualified interventional~     neuroradiologists. In the Rhone area, only one hospital has the authorization to perform~     mechanical thrombectomy. Therefore, transferring directly eligible acute ischemic stroke~     patients for mechanical thrombectomy to this center constitutes an important stake of the~     triage of suspected acute ischemic stroke patients. Some validated scores for the~     identification of severe strokes and large vessel occlusion, including the Cincinnati~     prehospital stroke severity scale (CPSSS), appear to be relevant for pre-hospital use in~     order to identify patients potentially eligible for mechanical thrombectomy and address them~     to a stoke unit with interventional radiology center.~   "
29459|NCT03181399|"~     Forty-five subjects receiving no dietary therapy with a proven G1D diagnosis will be~     enrolled. To evaluate the effect of C7 supplementation of a regular diet on a EEG activity in~     addition to IQ, language, working memory, processing speed, emotional and behavioral~     functioning, ataxia, and other neuropsychological and neurological performance indices in~     children and adults genetically diagnosed with G1D receiving a regular diet at enrollment.~   "
29460|NCT03181386|"~     The purpose of this study is to evaluate the safety of a protocol which does not suspend the~     new oral anticoagulants (dabigatran, rivaroxaban and apixaban) in front of dental extractions~     in patients with non-valvular atrial fibrillation.~   "
29461|NCT03181373|"~     Longitudinal descriptive study of a cohort of twenty brain-damaged patients for a two years~     period.~   "
29462|NCT03181360|"~     Stroke is a leading causes of death and disability. At least 20% of strokes occur during~     sleep, so- called 'wake up stroke'. Thrombolysis with the clot-busting drug alteplase is~     effective for acute ischaemic stroke, provided that it is given within 4.5 hours of symptom~     onset. Patients with wake-up stroke are currently ineligible for clot-busting therapy.~     Previous studies indicate that many wake-up strokes occur just before awakening.~      In this study, patients with wake-up stroke will be randomized to thrombolysis with~     tenecteplase and best standard treatment or to best standard treatment without thrombolysis.~     Tenecteplase has several potential advantages over alteplase, including very rapid action and~     that it can be given as a single injection. Prior to thrombolysis, a brain scan must be done~     to exclude bleeding or significant brain damage as a result from the stroke. We will use a CT~     scan to inform this decision. CT is used as a routine examination in all stroke patients.~     Other studies testing clot-busting treatment in wake-up stroke are using alteplase and more~     complex brain scans, which are not routinely available in the emergency situation in all~     hospitals.~   "
29463|NCT03181347|"~     Obesity and its associated diseases are increasing worldwide. However, the mechanisms behind~     the development of obesity is not fully understood. There is evidence that intestinal~     bacteria may play a role in the development and perpetuation of obesity through regulation of~     energy and fat storage.~      Bariatric surgery is currently the most effective modality for treating severe obesity with~     evidence to support long-term sustained weight loss and improvement in obesity-related~     comorbidities. The two most commonly performed bariatric surgical procedures are the~     Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG). RYGB leads to greater weight~     loss than SG and improved diabetes control in patients following surgery. Despite the success~     of RYGB and SG in inducing weight loss and improving comorbidities, the underlying mechanisms~     leading to clinical improvement following these operations is not completely understood.~     Multiple factors are thought to play a role including reduced caloric intake, decreased~     nutrient absorption, increased satiety, release of hormones and shifts in bile acid~     metabolism.~      Recent evidence has suggested that the gut bacteria mediates a number of the beneficial~     effects of bariatric surgery. Small studies have demonstrated changes in the composition and~     diversity of the gut microbiota after RYGB and SG in humans. One study also confirmed~     long-term microbial changes for RYGB. However, comparative trials have been small (less than~     15 participants per treatment group) and important differences between specific bacterial~     populations have not been well elucidated. Furthermore, no human study has examined the~     differences in bacterial composition following RYGB and SG in relation to their metabolic~     consequences.~      The aim of this study is to investigate and compare the metabolic and microbial changes that~     occur with RYGB, SG, and dietary controls. Specifically, we aim to use a systems biology~     approach utilizing powerful analytic techniques including metagenomics, metabolomics, and~     multiplex immune profiling to define the combined microbial, metabolic and immunologic~     changes that occur after bariatric surgery.~   "
29464|NCT03181334|"~     Participants will be mailed an invitation to complete CRC screening along with a fecal~     immunochemical test (FIT) kit, containing a 1-sample Polymedco Over the Counter (OC) Sensor~     FIT, simplified English/Spanish instructions on performing the test, educational information~     about colorectal cancer screening and a return mailer with prepaid postage.~      Processes that will be used to promote screening completion include automated and live~     phone call reminders to encourage completion of FIT testing.~      Participants will be randomly assigned to 1 of 5 study arms across 3 conditions, described~     below:~        1. Condition 1 (Pure Control):~             -  Branch I: Participants assigned to the control condition will receive a FIT kit and~               the standard invitation letter to participate in free screening.~        2. Condition 2 (Time Restriction):~             -  Branch II: Participants will receive a FIT kit and invitation letter to participate~               in free screening with a 1-week time restriction.~             -  Branch III: Participants will receive a FIT kit and invitation letter to~               participate in free screening with a 3-week time restriction.~        3. Condition 3 (Time Restriction + Incentive):~             -  Branch IV: Participants will receive a FIT kit and invitation letter to participate~               in free screening requesting they return the kit within 1-week for a higher~               monetary incentive or within 3 weeks for a lower (half of the higher) monetary~               incentive.~             -  Branch V: Participants will receive a FIT kit and invitation letter to participate~               in free screening requesting they return the kit within 1-week for a higher (same~               as lower in Branch IV) monetary incentive or within 3 weeks for a lower (half of~               the higher) monetary incentive.~      Participants with a normal test result will receive a personal letter confirming this with~     invitations to complete a repeat screening in subsequent year(s). Participants receiving an~     abnormal FIT result will be navigated to complete a diagnostic colonoscopy.~      Participants continuing in the screening program in subsequent years will receive letters~     emphasizing the importance of repeat screening to prevent adverse CRC outcomes.~   "
29465|NCT03181321|"~     The purpose of this study is to assess the efficacy of an internet-based firefighter health~     and wellness program for volunteer fire departments.~   "
29466|NCT03181308|"~     This is a multicenter, open-label, nonrandomized, Phase 1b, dose-escalation study of~     Carotuximab (TRC105) in combination with standard dose Nivolumab in patients with metastatic~     NSCLC.~   "
29609|NCT03179436|"~     This study will assess the safety, tolerability, pharmacokinetics (PK), and preliminary~     efficacy of escalating doses of MK-1308 when used in combination with pembrolizumab in~     participants with advanced solid tumors.~   "
29467|NCT03181295|"~     Despite knowing that exercise improves health, primary care providers (PCPs) do not regularly~     assess physical activity (PA) levels or use proven techniques to help patients to increase~     their PA levels. Studies have shown that PCPs don't talk to patients about their PA levels~     because they don't feel they have adequate knowledge or resources to help their patients.~     Additionally they don't feel they have time to provide personalized advice regarding PA.~      This study will use tablet computers and email to engage patients in contemplating their own~     PA levels and starting conversations with their PCPs. Electronic surveys delivered via~     tablets and email prior to periodic health reviews will be used to support customized,~     patient-centred health care. The patient's survey responses will be used to develop a~     printable 'toolkit' with individualized PA recommendations, a personalized exercise~     prescription (Rx), as well as patient-specific educational and community resources. The~     exercise Rx and resources can be edited by the PCP based on the resulting discussion between~     patient and PCP.~      The overarching aim of this study is to determine how the use of technology in family~     doctors' offices can help patients to engage with their PCPs regarding PA and ultimately~     increase their PA levels.~   "
29468|NCT03181282|"~     While deep brain stimulation of the subthalamic nucleus (STN-DBS) is commonly used to reduce~     tremor, muscle stiffness, and bradykinesia in people with Parkinson disease (PD), preliminary~     studies suggest balance may worsen and falls may increase after STN-DBS. Walking speed, known~     to be reduced in PD, typically improves after surgery; however, other important gait~     qualities may not improve. Given the potential for worsening balance and gait and increasing~     falls after surgery, it is imperative that researchers explore interventions that complement~     the positive effects of STN-DBS and delay worsening of balance and gait.~      Physical therapy (PT) is reported to be effective in improving balance and walking in people~     with PD. However, there have been no studies to investigate how individuals with STN-DBS~     respond to PT. As such, it is unclear if exercise in the post-DBS population is safe,~     feasible, and effective. The purpose of this study is to examine the safety, feasibility, and~     efficacy of PT in people with PD with STN-DBS.~      The investigators hypothesize that PT will be safe and feasible for people with PD with~     STN-DBS. Further, the investigators hypothesize that those assigned to PT group will~     demonstrate improvements in balance and gait while those assigned to the control group will~     demonstrate no change or a decline in balance and gait.~   "
29469|NCT03181269|"~     This study will explore the effects of skin-to-skin contact (SSC) between mothers and their~     babies on the infant intestinal microbiome, the maternal skin microbiome and the breast milk~     microbiome. This will be accomplished by administering an intervention education session to~     one group and a placebo education session to the second group in order to influence the~     magnitude of total SSC defined by the frequency and duration of contact time between the two~     groups.~   "
29470|NCT03181256|"~     This research trial studies the long term follow-up for early detection of lung cancer in~     current or former smokers. Following up on smokers by collecting and analyzing specimens in~     the laboratory, performing chest computed tomography (CT) scans, as well as reviewing medical~     records may help doctors detect lung cancer at an earlier stage.~   "
29471|NCT03181243|"~     To compare the acceptance, safety, and efficacy of needle-free jet anaesthetic technique~     (MadaJet) versus needle injection for sperm retrieval in patients with azoospermia.~   "
29472|NCT03181230|"~     This study plans to learn more about how the energy system works in girls with Turner~     syndrome. This is important to know so that the investigators understand how Turner syndrome~     relates to diseases such as diabetes, extra weight gain, heart disease and liver disease, and~     how this impacts day to day life.~   "
29473|NCT03181217|"~     The study will consist of four occasions with one week between the occasions. fMRI will be~     performed to monitor hypothalamic activity before and after an ingestion of 1 of the~     following 4 stimuli (300 ml of each): water at room temperature, water at 0 degrees Celsius,~     glucose solution at room temperature, glucose solution at 0 degrees Celsius. The last two~     stimuli both contain 75 gram glucose. The order of conditions will be randomly assigned to~     the subjects. Functional connectivity of the hypothalamic regions will be assessed by~     analysing the resting state fMRI.~   "
29474|NCT03181204|"~     The primary objective of this study is to to verify the feasibility of obtaining and~     comparing two epithelia in two populations based on the following experiments:~        -  Differentiation of an Induced Pluripotent Stem cell (iPS) clone derived from cutaneous~          biopsy in a population of heavy smokers (plus patients with chronic obstructive~          pulmonary disease) in order to obtain differentiated bronchial epithelia in vitro.~        -  For each of these same patients, generation of bronchial epithelium in vitro from~          bronchial biopsy using human bronchial epithelial cells (HBECs) in air-liquid interface~          (ALI) cultures.~   "
29475|NCT03181191|"~     Delineation of the anatomical location, cellular origin and molecular basis of gut-derived~     glucagon secretion~   "
29476|NCT03181178|"~     Prevention of malnutrition in infants and children requires access and intake of nutritious~     food starting at birth with exclusive breastfeeding for the first 6 months of life,~     breastfeeding in combination with complementary foods from 6-24 months of age, access to~     clean drinking water and sanitation, access to preventive and curative health care (including~     prenatal).~      In Ghana, the Demographic and Health Survey of 2014 reports rates of stunting, wasting and~     underweight in children aged 0-59 months are 28%, 14% and 9% respectively. Furthermore,~     height for age starts dropping from age 4-6 months with children aged 6-23 months being more~     likely to be stunted (40%) than those below 6 months (4%). Infant and young child feeding~     data show that for breast-fed children ranging from 6 months through 35 months of age,~     cereals are predominantly the first foods introduced in the diet (6-8 months of age). As the~     child grows older, consumption of fruits rich in Vitamin A, other fruits and vegetables and~     meat, fish, poultry and eggs are reported by the mothers. The Demographic and Health Survey~     (DHS) found that the proportion of breast fed children aged 6-23 months who received a~     recommended variety of foods the minimum number of times per day increases with child's age~     from 28% in children 6-8 months to 50% in children aged 18-23 months.~      The study objective is to examine the effect of providing a macro- and micro-nutrient~     fortified complementary food supplement (KokoPlusTM) on growth and nutritional status of~     Ghanaian infants.~   "
49533|NCT02918565|"~     A 5-arm randomized trial to determine what components of a text message intervention are~     necessary to reduce hazardous drinking among young adults and mechanisms through which these~     changes occur.~   "
29477|NCT03181165|"~     Type 2 diabetes represents a significant burden to both the individual and our healthcare~     system. Individuals with type 2 diabetes are typically prescribed one or more~     glucose-lowering medications, many of which have undesirable side effects (e.g., nausea, risk~     of cardiovascular complications, weight gain) and cost our healthcare system a lot of money.~     An alternative strategy to lower blood glucose is to consume a low-carbohydrate diet.~     However, adjusting medications after choosing to follow a low-carbohydrate diet can be~     difficult. Delivering a low-carbohydrate diet through pharmacists could circumvent this~     difficulty in medications adjustment because pharmacists are trained to adjust medications.~     In this study the investigators will determine whether type 2 diabetes patients can reduce~     medications and improve blood glucose by following a low-carbohydrate, low-calorie diet under~     the direction of a pharmacist.~   "
29478|NCT03181152|"~     To Assess the Utility of Impulse Oscillometry on a Differential Diagnosis among the Patients~     with ACOS,asthma and COPD over Age 40.~   "
29479|NCT03181139|"~     Retrospective analysis of pre and post-Enhanced Recovery after Surgery for Total mastectomy~     pathway implementation.~   "
29480|NCT03181126|"~     This dose-escalating study is to determine the safety, pharmacokinetics, and preliminary~     efficacy of venetoclax in combination with navitoclax and chemotherapy in adult and pediatric~     participants with relapsed/refractory acute lymphoblastic leukemia (ALL) or~     relapsed/refractory lymphoblastic lymphoma.~   "
29481|NCT03181113|"~     In this cohort study, patients with chronic hepatitis B who prior participated in TB1211IFN~     study and received at least 39 doses of peginterferon alfa will be enrolled. HBsAg/anti-HBs~     level, HBeAg/anti-HBe level, Serum HBV DNA load and alanine transaminase level will be test~     every year from the second year to the fifth year after the ending of peginterferon alfa~     treatment, and long-term benefit of interferon treatment will be evaluated.~   "
29482|NCT03181100|"~     Objectives:~      Primary:~      To determine if targeted therapy + atezolizumab (cohorts 1-3) will lead to improved overall~     survival (OS) in patients with anaplastic thyroid carcinoma (ATC).~      Secondary:~        1. To evaluate the safety and efficacy (RECIST response rate, progression-free survival~          [PFS]) of targeted therapy + atezolizumab (cohorts 1-3) in ATC and poorly differentiated~          thyroid cancer (PDTC).~        2. To determine the OS in patients with PDTC treated with targeted therapy + atezolizumab~          (cohorts 1-3).~        3. To determine the efficacy (RECIST response rate, progression-free survival [PFS]) and OS~          of ATC and PDTC patients treated with taxanes + atezolizumab (cohort 4)~   "
29483|NCT03181087|"~     The purpose of this study is to evaluate the safety of umbilical cord mesenchymal stem cell~     local intramuscular injection for treatment of uterine scars by a prospective, single-center,~     open, and single-arm clinical trial.~   "
29484|NCT03181074|"~     This early post-marketing study is an observational, prospective and descriptive study of~     patients receiving daclatasvir for the treatment of Chronic Hepatitis C at participating~     sentinel sites for the CNFV in Mexico.~   "
29485|NCT03181061|"~     This national, qualitative study of physicians who provide abortion care aims to better~     understand the facilitators of abortion provision among generalist clinicians in OB-GYN and~     Family Medicine.~   "
29486|NCT03181048|"~     The study will assess the outcomes of patients treated with concomitant hip arthroscopy at~     the time of periacetabular osteotomy (PAO) for patients with hip dysplasia compared with~     patients treated with PAO alone.~   "
29487|NCT03181035|"~     This is a pilot study in the form of a prospective Phase II, single centre, single arm~     hypoxia study of oral tongue cancer with FAZA-PET imaging and pimonidazole targeted IHC of~     surgical specimens.~   "
29488|NCT03181022|"~     The purpose of the Tailored Motivational Interviewing Project (TMI) is to develop an~     implementation intervention to increase evidence-based patient-provider communication~     strategies using a Motivational Interviewing (MI) framework.~   "
29489|NCT03181009|"~     Few studies have been conducted to optimize safety of multiple food allergen oral~     immunotherapy (OIT) in conjunction with Omalizumab as well as to identify the immunological~     mechanism(s) underlying any long-lasting effects of OIT. To address these issues in the field~     of food allergy research, we have designed this study to test whether: 1) Omalizumab improves~     the safety of multiple food allergen OIT in subjects with multi food allergies, 2) Omalizumab~     treatment with multiple food allergen OIT is associated with the ability to use a lower~     maintenance dose of each food allergens in the OIT regimen, particularly in younger subjects~     with food allergies.~   "
29490|NCT03180996|"~     This study is a prospective non-interventional, multi-centre study of the Vascutek~     Fenestrated Anaconda™ system, and is essentially a post-market study. The Vascutek~     Fenestrated Anaconda™ system is a custom made device used for the treatment of Abdominal~     Aortic Aneurysm.~   "
29491|NCT03180983|"~     CONTEXT: France is still one of the biggest consumers of antibiotics in Europe. An~     explanation for this increase in consumption would be aging. Thus, part of this aging~     population lives in nursing home, where the urinary tract infection is the second most~     suspected pathology. However, it can most often be bacteriuria requiring no antibiotic~     therapy. In nursing home, nurses who alert prescribers when an infection is suspected by~     describing clinical signs.However, his propensity to perform too rapidly and systematically~     an examination with dipsticks leads the physician to prescribe antibiotic. This is how a~     program called ATOUM is set up to reduce the prescription of antibiotics in nursing home. The~     present ATOUM 4 study builds on this program.~      OBJECTIVE: To measure the effect of a nurse-centered multimodal intervention involving~     training and sensitization on urinary tract infection, asymptomatic bacteriuria, antibiotic~     resistance and interprofessional communication on antibiotic therapy. METHODS: This will be a~     randomized double-arm interventional study in 40 nursing home. The intervention group of 20~     nursing home will receive a blended-learning intervention.~   "
29492|NCT03180970|"~     The purpose of this study is to assess whether lower Lugol's solution concentration can~     perceive the same image quality of early esophageal squamous neoplasia.~   "
29501|NCT03180853|"~     The purpose of this study is to document the participants characteristics, disease burden,~     and clinical management of participants in the United States who are treated for relapsed~     multiple myeloma in routine medical practice with a treatment strategies that include a~     proteasome inhibitor (PI) and/or immunomodulatory drug (IMiD) used either as monotherapy or~     combination therapy with other treatments.~   "
29493|NCT03180957|"~     Dupuytren's disease is a very common condition, affecting 4% of the general UK and US~     population. It causes the fingers to curl irreversibly into the palm and can be extremely~     disabling. The disease usually starts as a small firm lump (nodule) in the palm, and in about~     40% of patients advances to form cords that pull the fingers into the palm. There is no~     approved treatment for the early stage of disease. Once patients have established~     deformities, the diseased tissue can removed by surgery or cut using less invasive techniques~     such as a needle or an enzyme. However, recovery following surgery usually takes several~     months and recurrence rates with the less invasive techniques are high.~      The investigators have unravelled the cellular process that initiates and maintains the~     disease progress and identified tumour necrosis factor (TNF) as a new target for treatment.~     Based on these findings the investigators plan to test the effects of adalimumab, an anti-TNF~     drug which currently approved for use in patients with rheumatoid arthritis and other~     inflammatory conditions. The aim of the study is to find out whether treatment by injection~     with adalimumab directly into the diseased tissue will control the advance of early~     Dupuytren's disease better than a placebo injection with normal saline.~      The investigators will first carry out a small trial in up to 40 patients with established~     disease to determine the best dose that reduces the activity of the cells responsible for the~     disorder (Dose Response study). In this part patients who will be having surgery to remove~     their diseased tissue will receive a single injection of adalimumab into the nodule in their~     hand about 2 weeks before surgery. The tissue that is then removed during surgery will be~     analysed in the investigator's laboratories to determine the effect of the drug on the~     tissue. Patients will be followed for 12 weeks after surgery.~      In the second part of the study the investigators will assess whether the optimal dose of the~     drug prevents early disease advancing in 138 patients (Early Disease study). Patients who~     take part in the second part of the study will receive a total of 4 injections of adalimumab~     into the nodule in their hand at three monthly intervals. They will then be checked at 3 & 9~     months after the last injection. In additional to assessing the effect of the injections on~     the nodule and hand function, information will also be collected to assess the cost~     effectiveness of the treatment.~   "
29494|NCT03180944|"~     This study was to test an appropriate concentration of Lugol's solution which can reduce the~     mucosal irritation and provide high image quality to ensure endoscopy examination by a~     randomized blinded controlled trial.~   "
29495|NCT03180931|"~     Bioresorbable vascular scaffold (BVS, ABSORB BVS1.1, Abbott Vascular) has been approved (CE~     mark) and is used in daily clinical practice. While recent randomized controlled trials~     comparing BVS versus metallic drug-eluting stent showed higher risk of definite or probable~     device thrombosis after BVS implantation, the causes underlying thrombotic events occurring~     beyond one year after scaffold implantation remain unclear and require investigation in an~     independent manner.~      The INVEST registry is a world-wide, multi-center, observational, retrospective,~     investigator-initiated registry, which will include any patients who suffered from very late~     (>1 year) scaffold thrombosis, underwent optical coherence tomography (OCT) at the time of~     thrombosis and provided informed consent for the further use of their health related data for~     this registry.~   "
29496|NCT03180918|"~     Background:~      Due to the remarkable improvement in treatments these last decades, long term survival can be~     expected in more than 80% of childhood cancer patients. Unfortunately, cancer treatments can~     be harmful to the gonads and can affect reproductive and endocrine functions. While loss of~     fertility is a major concern for most patients, sperm cryopreservation should be offered to~     all pubertal male patients. For prepubertal boys, only the experimental option of testicular~     biopsy in order to cryopreserve testicular stem cells can be proposed.~      Primary aims~      - To cryopreserve testicular tissue of prepubertal patient receiving highly gonadotoxic~     oncological treatment.~      Secondary aims~        -  To cryopreserve testicular tissue after failure of sperm cryopreservation in pubertal~          patient with high risk of infertility~        -  To create a database in order to record clinical and biological follow-up data~        -  To create a research biobank for future research projects~      Multicentric study: HUG, CHUV, UKBB~   "
29497|NCT03180905|"~     The researchers want to find out more about a standalone software application, ImPACT Online~     and how it relates to other commonly used tests of memory, attention and reaction time.~     ImPACT Online is a computer-based neurocognitive test for concussion management. The test was~     designed to help measure the effects of concussion on cognitive processes (for example,~     memory, attention, brain speed) and visual functioning.~   "
29498|NCT03180892|"~     Background: Autoimmune hypothyroidism has been regarded as the most common cause of primary~     hypothyroidism in iodine sufficient area and has relationship with excess iodine induced~     hypothyroidism. However, non-immune related hypothyroidism and its relationship with excess~     iodine have been rarely evaluated.~      Objective: Therefore, the investigators planned to calculate proportion of non-immune related~     hypothyroidism and relationship with iodine intake using nationwide data from Korea National~     Health and Nutrition Examination Survey (KNHANES) 2013-2015.~      Design:~        1. Korea National Health and Nutrition Examination Survey VI (2013 to 2015) - The national~          data - which is the government designated statistics (Approval No. 117002 ) of South~          Korea based on the Article 17 of the National Health Promotion Act - were used. The~          survey was approved by the Institutional Review Board of the Korea Centers for Disease~          Control and Prevention, and provides only non-identified measures for academic research~          purposes.~        2. The participants who were examined for thyroid stimulating hormone, free thyroxine,~          thyroid peroxidase antibody (TPO Ab), and urine iodine concentration (UIC) were~          included.~        3. The proportion of immune related and non-immune related hypothyroidism was evaluated.~          Demographic variables and severity of hypothyroidism were compared between the two~          groups. To analyze iodine effect on hypothyroidism in TPO Ab positive or negative~          population, prevalence of hypothyroidism were assessed in each TPO Ab negative and~          positive population according to UIC subgroups.~        4. This study protocol was approved by IRB of SMC (2017-05-149).~   "
29499|NCT03180879|"~     This project is the in-house development of a 200 mg ibuprofen acid orodispersable tablet~     (ODT; meltlet). It is designed to appeal to consumers who want a dosage form that may be~     taken without water and can be used 'on the go'. Vanquish has an improved organoleptic~     profile compared to the currently marketed meltet by the Sponsor. ODTs are also considered as~     a suitable dosage form for children who may be reluctant to swallow tablets. This product has~     the potential for application in both adults and children due to the convenience of the~     format and the ease of administration for both groups.~      This will be the first pharmacokinetic (PK) assessment of the ibuprofen acid ODT formulation.~   "
29500|NCT03180866|"~     This is a proof of concept, investigator blinded study to evaluate the efficacy and safety of~     a novel combination of a home narrow band ultraviolet B (NBUVB) lamp with an occlusive~     dressing in adult subjects with mild to moderate psoriasis vulgaris. Two interpatient arms~     will be used to compare the efficacy of combination of NBUVB with an occlusive dressing~     (active) to no treatment (control). 32 patients will be enrolled in this 30 week study.~   "
30943|NCT03162016|"~     Limitation of donor site and significant postoperative morbidity are often described in~     connective tissue graft harvesting. We want to show if mucoderm used in tunnel technique to~     recover miller class I and II recessions defects could be an alternative to connective tissue~     graft.~   "
29502|NCT03180840|"~     This open-label switchover study will assess the safety, efficacy, and pharmacokinetics of~     pegunigalsidase alfa (PRX-102) 2 mg/kg administered every 4 weeks for 52 weeks in Fabry~     patients previously treated with ERT: agalsidase alfa or agalsidase beta for at least 3~     years. Safety and efficacy exploratory endpoints will be evaluated throughout the study~     period and pharmacokinetics will be obtained on Day 1 and Week 52.~   "
29503|NCT03180827|"~     Background:~      Due to the remarkable improvement in treatments these last decades, long term survival can be~     expected in more than 80% of childhood cancer patients. Unfortunately, cancer treatments can~     be harmful to the gonads and can affect reproductive and endocrine functions. While loss of~     fertility is a major concern for most patients, only the experimental option of ovarian~     tissue cryopreservation can be proposed to prepubertal girls with a high risk of infertility.~     For pubertal patient, cryopreservation of mature oocytes after ovarian stimulation can be~     offered if oncological treatment debut can be delayed. As it is often not possible, ovarian~     tissue cryopreservation can also be offered.~      Primary aims~      - To cryopreserve ovarian tissue of prepubertal and pubertal patient who will be receiving~     highly gonadotoxic oncological treatment.~      Secondary aims~        -  To create a database in order to record clinical and biological follow-up data~        -  To pool resources with Fertisave Registry~        -  To create a research biobank for future research projects~      Monocentric study: HUG~   "
29504|NCT03180814|"~     Aging causes anatomical and physiological changes in the cardiovascular system and autonomic~     function with decline in its maximum function. This study aimed to evaluate the acute effects~     of whole body vibration on cardiovascular system, autonomic function and heart variability in~     healthy young and elderly. The investigators' hypothesis is that whole body vibration has~     different effects in young and elderly.~   "
29505|NCT03180801|"~     FLU-v is a broad spectrum influenza vaccine that targets regions in the influenza virus that~     are conserved among many different influenza strains.This study aims to assess efficacy of~     FLU-v vaccine in protecting healthy FLU-v vaccinated volunteers against an influenza~     challenge delivered intranasally under quarantine.~      Efficacy of FLU-v will be assessed by measuring the incidence and severity of the disease in~     the treatment groups compared to the placebo group. In addition, the immune responses of the~     volunteers to FLU-v will also be explored.~   "
29506|NCT03180788|"~     The aim of this study is to evaluate the role of traction assisted ESD in comparison to~     traditional ESD on procedural time and outcome in patients with large, non pedunculated~     colorectal polyps.~   "
29507|NCT03180775|"~     Recently, the investigators have been screening for anti-atherogenic or pro-atherogenic amino~     acids (AAs) in the macrophage model system to better understand their role in atherogenesis.~     The findings so far suggest that specific AAs induce selective anti-atherogenic effects~     (glycine, alanine, leucine and cysteine) or pro-atherogenic effects (glutamate and glutamine)~     in macrophages. Taking together the above previous reports with the mechanisms behind~     macrophage foam cell formation and atherogenesis, it is possible that AAs could be~     anti-atherogenic or pro-atherogenic via their mechanism of action on macrophage foam cell~     formation. This paradigm may serve as a basis for the development of novel cardio-protective,~     anti-atherogenic nutritional, or therapeutic approaches, that should be studied in human~     trials.~   "
29508|NCT03180762|"~     The purpose of this study is to investigate the safety and tolerability of JNJ-64140284~     versus placebo after single oral dose administration (ascending dose levels) under fasted~     condition, to characterize the pharmacokinetics (PK) of JNJ-64140284 in plasma, cerebrospinal~     fluid (CSF) and urine after single oral dose administration and to investigate the effect of~     food (high fat/high calorie) on the PK of JNJ-64140284 following single oral dose~     administration.~   "
29509|NCT03180749|"~     Post-Marketing Clinical Follow-up of an Anular Closure System (Barricaid®) to Confirm~     Comparability of Outcome between Devices with Subcomponents from Two Different Suppliers~   "
29510|NCT03180736|"~     The purpose of this study is to evaluate the effects of the addition of daratumumab to~     pomalidomide and dexamethasone in terms of progression-free survival in subjects with~     relapsed or refractory Multiple Myeloma.~   "
29511|NCT03180723|"~     Type I membranoproliferative glomerulonephritis (MPGN) is a relatively uncommon glomerular~     disease, constituting 1.8% of renal biopsies performed in Rochester, minnesota, United States~     of America, at the Mayo Clinic, between 1993 and 2008. The prognosis of idiopathic Type I~     MPGN is relatively poor. Recently, Irish series, slightly more than 50% of patients developed~     end stage renal disease after a mean follow up of 14 years . The disease may recur after~     renal transplantation . High-dose glucocorticoids have been used to treat this disease in~     children but there is no established treatment in adults.~   "
29512|NCT03180710|"~     This is a bicentric, double-blinded, randomised, four-period crossover phase 1 trial, using~     automated 30-hour euglycemic clamp in subjects with type 2 diabetes mellitus.~   "
29513|NCT03180697|"~     Targeted therapy with bevacizumab is the main method to prolong the progression-free survival~     of patients with recurrent malignant gliomas in recent years. Using noninvasive imaging~     methods to predict which RMG may respond to bevacizumab regimen therapy is a clinical problem~     ; on the other hand, repeated gadolinium enhancement may increase the risk of gadolinium ion~     deposition of brain tissue. Furthermore,there may be a false response phenomenon and cause~     assessment bias.in the evaluation of treatment efficacy,owing to bevacizumab is only~     anti-tumor angiogenesis.~      Amide Proton Transfer (APT) is a new molecular imaging technique. Our previous studies have~     shown that imaging features and signal changes of APT can fully reflect the therapeutic~     effect of malignant glioma,without the injection of contrast agent and avoid the side~     effects.~      RMG patients will be recruited in this study . This project will be designed multi-center,~     prospective, observational clinical research. The changes of APT signal intensity before and~     after treatment will be compared with those of different types of RMG line. The relationship~     between APT imaging characteristics and clinical end point events will be investigated and~     compared with conventional MR imaging technique. The sensitivity, specificity and accuracy of~     the progression-free survival and median overall survival will be measured after treatment~     with bevacizumab.~   "
30944|NCT03162003|"~     The purpose of the trial is to investigate new clinical tests that could predict what~     treatments work best for certain patients with advanced prostate cancer by identifying~     markers and indicators present in blood and tissue which correlate with treatment response.~   "
29514|NCT03180684|"~     The purpose of this study is to investigate the efficacy and safety of VGX-3100 followed by~     electroporation (EP) with CELLECTRA™ 2000 alone or in combination with imiquimod in~     participants with human papillomavirus HPV-16 and/or HPV-18 related high grade squamous~     intraepithelial lesion (HSIL) of the vulva. In this study, all eligible participants will~     receive four to six doses of VGX-3100 or VGX-3100 administration in combination with~     imiquimod.~   "
29515|NCT03180671|"~     The study will be conducted in four groups of 20 patients in age of 20-30 years with complete~     dentition or single tooth loss in lateral regions, with masticatory muscle pain in the~     history or during examination and overuse and/or chronic tensing of the masticatory muscles.~     Patients will be randomly assigned to the groups.~      Each person will be measured twice before and after use of selected anterior deprogrammer.~     The following assessment tools will be applied:~        -  surface electromyography of masseter and temporal muscles,~        -  intraoral pin-supported registration to draw a gothic arch.~      Measurements will be made before and after intervention to assess the effect of anterior~     deprogrammer application on the tone of the selected masticatory muscles and condyles~     position in mandibular fossa. The first group (control) will be counsel with an explanation~     of the pathomechanism of masticatory muscles pain and preventive principles. In the second~     group, the Sliding Guide will be used for a period of 12-15 minutes, in the third Dawson~     B-Splint for 7 days, and in the fourth Kois deprogrammer for 14 days. Devices in group 3 and~     4 will be used by patients for 24 hours a day, with breaks for oral hygiene procedures and~     eating/drinking.~      The aim of the study is to evaluate the effectiveness of selected anterior deprogrammers.~   "
29516|NCT03180658|"~     Objective: To compare the effect of guided tissue regeneration (GTR) + concentrated growth~     factors (CGF) + bone graft and CGF + bone graft in the treat of II° furcations of human~     mandibular molars. Methods: At least thirty II°furcation involvements in mandibular molars~     will be included and randomly divided into two groups. The experimental group will accept GTR~     + CGF + bone graft therapy, and the control group will accept CGF + bone graft therapy. The~     clinical examination and cone beam computed tomography (CBCT) will be performed at baseline~     and 1 year post-surgery.~   "
29517|NCT03180645|"~     The objective of this POC clinical study is to evaluate the moisturising effects on fine~     lines and wrinkles, texture, barrier function, hydration and elasticity delivered by 4 weeks~     of twice daily application of the test product on participants presenting visible signs of~     ageing.~   "
29518|NCT03180632|"~     The purpose of this study is to determine the effect of a single dose of Lorazepam on~     salivary cortisol in children undergoing digestive endoscopy. To do so, the patients will be~     randomized in three groups. The first group receives the Lorazepam, the second group receives~     a placebo and the last group receives no intervention. Each patient will have three saliva~     samples taken at three different time point on the day of the endoscopy and will be asked to~     fill out questionnaires on anxiety and overall satisfaction of the procedure.~   "
29519|NCT03180619|"~     The primary objective of this study is to evaluate the safety and tolerability of tenofovir~     alafenamide (TAF) in virologically suppressed chronic hepatitis B participants with renal~     and/or hepatic impairment.~      This study consists of 2 Parts. Approximately 90 renally impaired participants will be~     enrolled in Part A and approximately 30 hepatically impaired participants will be enrolled in~     Part B.~   "
29520|NCT03180606|"~     The present health care situation for the elderly in many countries is insufficient and not~     designed according to the health care needs of the aged population. In a pragmatic~     multicenter primary care setting (n= 1600), the investigators use an evidence based~     prediction model to find elderly (75+) with high risk for complex medical care or~     hospitalization and apply a differentiated and directed medical and social care to this risk~     group, in comparison to usual care. The intervention will include all the latest evidence~     based tools in the care of elderly (multi-professional team, social support, medical care~     home-visits, telephone support, general practitioner visits, etc). The project has high~     potential impact on the development of future care of elderly.~      In addition to the intervention study, several academic sub-studies focusing on patient's~     perspective, professional roles, equality, implementation and governance management of health~     care will be performed.~   "
29521|NCT03180593|"~     To assess the efficacy of Left Ventricular Hypertrophy (LVH) reduction and 24-hour blood~     pressure control of Valsartan 80mg or Nebivolol/Valsartan 5/80mg once daily as replacement~     therapy for currently treated or untreated hypertensive patients with LVH not at BP goal.~   "
29522|NCT03180580|"~     In Bangladesh, the prevalence of overweight and obesity among children varies from less than~     1% to 17.9% based on different reference standard. In 2014 school based country wide study~     has been demonstrated that among children (6-15 years of age), 9.6% were overweight and 3.5%~     children were obese. Childhood obesity is getting increasing attention due to its association~     with adult obesity and increased risk of co morbidities in adulthood. Childhood obesity is~     known to be an independent risk factor for adult obesity and once a child is obese, it is~     difficult to reverse through interventions. This suggests an urgent need to address~     overweight and obesity levels in childhood. The increasing trend of childhood obesity~     suggests urgent solution of the problem. There is no evidence of intervention for childhood~     overweight and obesity exists in Bangladesh. This feasibility study will be able to generate~     evidence for overcoming this upcoming epidemic in resource poor setting. If the proposed~     study will be able to address its objective that will create a possibility for developing a~     large cluster randomized trial in low resource setting like Bangladesh. This study will also~     give opportunity to our policy makers for advocating to the government of Bangladesh for~     adopting an obesity control policy for children.~      The aim of the study is to develop a school based healthy eating and active lifestyles module~     and assess feasibility and acceptability of the guideline in school setting.~      Outcome measures/variables:~      Healthy Eating and Active Living intervention material (Guideline, Tiffin box) Perception of~     children, parents and policy makers regarding obesogenic behavior Acceptance of children,~     parents and policy makers regarding planned intervention.~      Facilitators and barriers of Healthy Eating and Active Living.~   "
29523|NCT03180567|"~     As drug response is a complex trait in the majority of cases using an optimal starting dose~     for an individual may reduce the time taken to reach a stable INR, and reduce the risk of~     having either a high INR (with a risk of bleeding) or a low INR (with a risk of thrombosis)~   "
29524|NCT03180554|"~     Chronic widespread pain (CWP) is considered one of the most common and costly health~     conditions today. Due to its complex aetiology, both psychopharmacological and psychosocial~     treatments have been struggling to lower pain intensity and disability in patients suffering~     from CWP. However, recent research has found that there is a strong association between low~     parasympathetic nervous system (PNS) activity and pain intensity in patients diagnosed with~     CWP. Furthermore, research has suggested that increasing PNS activity by stimulating the~     vagus nerve may lower pain intensity in patients with CWP. This present study will~     investigate and compare the effects of non-invasive transcutaneous vagal nerve stimulation~     (tVNS) and deep breathing (DB) on low PNS activity in patients with CWP. We hypothesise that~     by stimulating the vagal nerve, either exogenously with tVNS or endogenously with DB, we will~     increase PNS activity and therefore decrease pain intensity, disability, and increase both~     psycho and physiological wellbeing in patients suffering from CWP.~   "
29525|NCT03180541|"~     This study aims to evaluate the coordinated implementation of Dialectical Behaviour Therapy~     in Community Mental Health Services in Ireland.~      There are three main objectives of the current study:~        -  evaluate the effectiveness of DBT for adults and adolescents attending Community Mental~          Health Services in multiple sites across Ireland~        -  conduct an economic evaluation of the coordinated implementation of DBT in community~          settings in Ireland~        -  evaluate the implementation initiative by means of quantity, quality and experience of~          the coordinated implementation~   "
29526|NCT03180528|"~     This phase II trial studies how well remetinostat works in treating patients with skin basal~     cell cancer. Remetinostat may slow the growth of basal cell cancer cells.~   "
29527|NCT03180515|"~     Continuous deep brain stimulation (cDBS) is an established therapy for the major motor signs~     in Parkinson's disease, however some patients find that it does not adequately treat their~     freezing of gait (FOG). Currently, cDBS is limited to open-loop stimulation,without~     real-time adjustment to the patient's state of activity, fluctuations and types of motor~     symptoms, medication dosages, or neural markers of the disease. The purpose of this study is~     to determine if an adaptive DBS system,responding to patient specific, clinically relevant~     neural or kinematic feedback related to FOG, is more effective than continuous DBS on the~     motor Unified Parkinson's Disease Rating Scale (UPDRS III) and gait measures of PD.~   "
29528|NCT03180502|"~     This randomized phase II clinical trial studies the side effects and how well proton beam or~     intensity-modulated radiation therapy works in preserving brain function in patients with IDH~     mutant grade II or III glioma. Proton beam radiation therapy uses tiny charged particles to~     deliver radiation directly to the tumor and may cause less damage to normal tissue.~     Intensity-modulated or photon beam radiation therapy uses high-energy x-ray beams shaped to~     treat the tumor and may also cause less damage to normal tissue. Patients will be more likely~     to be randomized to proton beam radiation therapy. It is not yet known if proton beam~     radiation therapy is more effective than photon-based beam intensity-modulated radiation~     therapy in treating patients with glioma.~   "
29529|NCT03180489|"~     Dapagliflozin is a medicine to treat diabetes. Its mechanism of action is via sodium-glucose~     co-transporter 2 (SGLT2) inhibition. In adults with diabetes, use of sodium-glucose~     co-transporter 2 inhibitors is associated with moderate weight (fat) loss, in addition to~     other health benefits, including decreased blood pressure, decreased inflammation, and~     decreased oxidative stress. It is unclear as to whether these health benefits are due to~     SGLT2 inhibition per se, or as a secondary effect of weight loss. We wish to compare the~     health benefits of dietary counseling for weight loss with and without concomitant use of an~     SGLT2 inhibitor.~   "
29530|NCT03180476|"~     The study is to evaluate the efficacy and safety of Apatinib as maintenace therapy for~     Nasopharyngeal Carcinoma With Metastasis after Chemoradiotherapy, including progress free~     survival(PFS)、overall survival (OS)、Quality of life score (QoL) and evaluation of drug~     safety.~   "
29531|NCT03180463|"~     The purposes of the study is to evaluate the safety and efficacy of human umbilical cord~     mesenchymal stem cells (hUC-MSC) in treating osteonecrosis of femoral head patients.~   "
29532|NCT03180450|"~     The purposes of the study is to evaluate the safety and efficacy of human umbilical cord~     mesenchymal stem cells (hUC-MSC) in treating heart failure patients~   "
29533|NCT03180437|"~     In this study, effects of γδT cells on human Pancreatic Cancer in combination with tumor~     reducing surgery, for example cryosurgery going to be investigated.~   "
29534|NCT03180424|"~     This study evaluates the impact of the treatment with L-Carnitine on the function of adults~     over 65 years, in conjunction with regular exercise. Simple randomization will be performed,~     distributing patients in 3 treatment groups, with L-Carnitine or Placebo, and with physical~     exercise at home or supervised.~   "
29535|NCT03180411|"~     The goal of this research study to help develop a tool to assist patients in making decisions~     about care during treatment for colorectal cancer. Information collected during this study~     will be saved to help develop future studies about patient decision making in cancer~     treatment.~   "
29536|NCT03180398|"~     This is a pilot study of implement multi-parametric MR imaging for organ delineation and~     tumor response assessment of prostate cancer patients being treated with radiation therapy.~     The study aims to generate intraprostatic lesions maps based on imaging, perform the~     treatment planning to compute the highest feasible simultaneous boosting dose to~     intraprostatic lesion and characterize longitudinal changes in imaging characteristics.~   "
29537|NCT03180385|"~     Pediatric patients often require prolonged mechanical ventilation after cardiac surgery which~     comes with many undesirable effects. As a result, neurally-adjusted ventilatory assist (NAVA)~     and biphasic positive airway pressure support (BiPAP) have been developed as non-invasive~     alternatives to providing respiratory support post-operatively. The investigators hypothesize~     that providing synchronized biphasic support with NAVA will be associated with shorter~     duration of non-invasive respiratory support, less sedation requirements, and reduced length~     of hospital stay. This is a prospective, randomized study. Subjects are randomized to receive~     either NAVA or BiPAP following their cardiothoracic surgery.~   "
29538|NCT03180372|"~     This multi-center clinical trial will evaluate the safety and long-term efficacy of hybrid~     fractional 2940 nm and 1470 lasers for improvement of symptoms of urinary incontinence.~   "
29539|NCT03180359|"~     Thanks to improved surgical techniques, postoperative management and immunosuppressive~     therapies, an increasing number of children benefit from renal, hepatic, cardiac and~     pulmonary transplantation. Infection is a significant cause of mortality and morbidity in~     these patients, particularly due to vaccine-preventable diseases. Vaccination is one of the~     effective means of reducing infection-related mortality in these particularly vulnerable~     children. It is mostly well-tolerated, but all the more effective as it is performed early~     before transplantation, at best during a dedicated consultation, according to a vaccine~     scheme adapted to the immunocompromised child. In the almost constant absence of clinical~     efficacy data in populations of immunocompromised individuals, vaccine efficacy is most often~     indirectly estimated by immunogenicity, using protective correlates obtained by extrapolation~     in immunocompetent individuals.~      Primary objective: To estimate the immunogenicity of vaccines recommended in children~     transplanted or candidate for renal, hepatic, cardiac and pulmonary transplantation, using~     serological titers measurements before and after a vaccine injection for: influenza,~     pneumococcus, chicken pox, measles, tetanus, hepatitis A and hepatitis B.~      These serological titers will be compared to correlates of protection existing for each~     valency.~      The evolution of serological titers will be described during the first year. The vaccination~     will be carried out within the routine care, according to the recommendations.~      Secondary objectives:~        -  describe and quantify the vaccination status of patients~        -  describe the vaccination coverage of their entourage~        -  evaluate the tolerance and efficacy of vaccines~   "
29540|NCT03180346|"~     The primary aim of this study is to determine if the SSI rate following revision total hip~     and knee arthroplasty is reduced in patients treated with the PICO device compared to~     patients with traditional postoperative dressings. Our secondary goals include; comparing the~     amount of wound drainage, rate of resolution of wound drainage, length of hospital stay,~     functional outcomes, and economic implications of wound drainage and SSI after revision~     arthroplasty comparing PICO and traditional dressings.~   "
29541|NCT03180333|"~     Conduct in Chinese healthy adult subjects:1.To observe the safety and tolerability of~     multiple-dose oral administration of different doses of PNA;2.By measuring the changing drug~     concentration in the plasma and urine after a single oral administration of different doses~     of PNA on the condition of fasting, the pharmacokinetic parameters of the single dose are~     estimated;3.By measuring the changing drug concentration in the plasma of PNA after a~     multiple-dose oral administration on the condition of fasting, the pharmacokinetic parameters~     of multiple-dose are estimated, and a basis for dosage regimens of the clinical research~     phase Ⅱ is provided;4.To study the effects of diet on the pharmacokinetic parameters via the~     changes of concentration of PNA in plasma after high-fat and high-calorie food.~   "
29542|NCT03180320|"~     Chronic heart failure (CHF) is a major and growing public health problem and poses economic~     burden on the society. There is a need for a safe, equipment-free, low-cost, and easily~     implemented exercise-based cardiac rehabilitation program for CHF patients in China.~     Baduanjin exercise, translated as 'eight silken movements', is one of the most common forms~     of traditional Chinese exercise and it could have value to be integrated into a~     exercise-based cardiac rehabilitation program for CHF patients, together with education,~     evaluation and consultancy. Accordingly, the BESMILE-HF program applying the Baduanjin~     exercise as the central component, has been developed in Guangdong Provincial Hospital of~     Chinese Medicine which is one of the largest hospitals of Chinese medicine in China. This~     project is to evaluate the efficacy and acceptability of BESMILE-HF program in patients with~     CHF in China, and it will be based on a randomized controlled trial and a qualitative study.~   "
29543|NCT03180307|"~     This is a phase 3, randomized, multi-center, single dose, open label, pivotal study in~     patients diagnosed with, or with high clinical suspicion of, ovarian cancer scheduled to~     undergo primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer~     surgery.~   "
29544|NCT03180294|"~     This phase II randomized trial studies how well bupropion hydrochloride works in improving~     sexual desire in women with breast or gynecological cancer. Bupropion hydrochloride may work~     by boosting sexual desire, energy, or motivation without causing intolerable or undesirable~     side effects.~   "
29545|NCT03180281|"~     Prevalence of diabetes is increasing rapidly both in China and all over the~     world.Hyperglycemia is an important risk factor and major hazard to cardiovascular and~     cerebrovascular diseases and even dangerous to human health.High glucose toxicity cause~     pancreatic β cell non-physiologic and irreversible damage.It is an important cause of β cell~     dysfunction.High glucose toxicity further suppresses insulin secretion of β cell, further~     even β-cell function failure.It is urgent to explore more effective and safety treatments~     which can also protect islet cells function.How to release high glucose toxicity , reverse~     the toxic effects of hyperglycemia on islet β cells as early as possible, and to maximize~     recover and protect the pancreatic β cell function is the keypoints of this study.Our aim is~     to explore the non-inferiority of new antidiabetic drugs DPP4 inhibitors on releasing glucose~     toxicity and protecting islet β cell function compared with traditional treatments on newly~     diagnosed type 2 diabetes,compare efficacy and safety of different oral antidiabetic drugs~     and insulin on newly diagnosed type 2 diabetes patients with high glucose toxicity and~     compare differences of different oral antidiabetic drugs and insulin on protecting pancreatic~     β-cell function.~   "
29546|NCT03180268|"~     This randomized phase III trial studies how well radiation therapy works compared with~     observation in treating patients with newly diagnosed grade II meningioma that has been~     completely removed by surgery. Radiation therapy uses high energy x-rays to kill tumor cells~     and shrink tumors.~   "
29547|NCT03180255|"~     Phase 2b trial evaluating the safety and efficacy of EGP-437, versus placebo using the~     EyeGate® II Drug Delivery System (EGDS) in patients having undergone cataract surgery with~     implantation of a monofocal posterior chamber intraocular lens (IOL).~   "
29548|NCT03180242|"~     The primary objective of this trial is to assess the pharmacokinetic similarity of EG12014~     (Test IMP) compared to reference products sourced from the European Union (Reference IMP 1:~     Herceptin® 150 mg powder for concentrate for solution for infusion) and the United States~     (Reference IMP 2: Herceptin® 440 mg powder for concentrate for solution for infusion) after~     intravenous infusion over 90 minutes of a single dose of 6 mg/kg trastuzumab in 3 parallel~     groups of healthy male subjects.~   "
29549|NCT03180229|"~     Propofol is one of the most commonly used anesthetic agents because of its ability to induce~     rapid and reliable collection. However, hypotension and injection pain in the induction are~     the most common complications. After induction of propofol; The cardiovascular system~     depresses, resulting in a drop in blood pressure due to decreased cardiac output and systemic~     vascular resistance. This may also contribute to the reduction of sympathetic tone activity~     in the central way, and slight reduction in the number of pulses that develop as a result of~     increasing vagal activity. İn order to attenuate these hemodynamic undesired effects caused~     by propofol, various agents were tried such as atropine, ephedrine, volume replacement ringer~     lactate, ketamine. Ondansetron and granisetron, which are used for postoperative nausea and~     vomiting prophylaxis, have been used as such. Therefore, ondansetron and granisetron were~     preventing hypotension induced by post-spinal and general anesthesia induction.~      The investigator also tried to demonstrate the effect of granisetron, another serotonin type~     3 (5-HT3) receptor antagonist for postoperative nausea and vomiting prophylaxis, on induction~     hypotension and intubation quality after propofol induction in this study~   "
29550|NCT03180216|"~     This Phase I dose-escalation trial is designed to evaluate the safety of rapidly generated~     multivirus-specific T-cell products with antiviral activity against CMV, EBV, adenovirus,~     HHV6, BK virus, JC virus, and human parainfluenza-3 (HPIV3), derived from eligible HSCT~     donors.~      In this trial, the investigators will utilize a rapid generation protocol for broad spectrum~     multivirus-specific T cells for infusion to recipients of allogeneic hematopoietic stem cell~     transplant (HSCT), who are at risk of developing EBV, CMV, adenovirus, HHV6, BKV and/or~     HPIV3, or with PCR/culture confirmed infection(s). These cells will be derived from HSCT~     donors, and the study agent will be assessed at each dose for evidence of dose-limiting~     toxicities (DLT).~      This study will have two arms: Arm A will include patients who receive prophylactic~     treatment, and Arm B will include patients who receive VSTs for one or more active infections~     with targeted viruses. Determination of the study arm will be determined by the patient's~     clinical status. Study arms will each be analyzed for safety endpoints and secondary~     endpoints.~   "
29551|NCT03180203|"~     The aim of this study is to investigate whether postoperative ventilation with~     INTELLiVENT-ASV(adaptive support ventilation) in high risk patients, after cardiothoracic~     surgery, is as effective, more user-friendly and as safe as compared to the conventional~     modes of ventilation.~   "
29552|NCT03180190|"~     Hydroxychloroquine(HCQ)play major role in management of many rheumatic diseases.~      Retinal toxicity from HCQ is serious side effect because even after the drug drug is~     discontinued, there is little if any visual recovery. For this reason, regular screening for~     retinal toxicity is recommended to detect early retinopathy and discontinue the therapy.~      Cytochrome P450 (CYP) enzymes play major roles in drug metabolism. Certain single-nucleotide~     polymorphisms(SNPs) in CYP genes may have a large impact on CYP enzyme activity.Polymorphisms~     in the cytochrome P450 gene might influence blood concentration some patients have a genetic~     predisposition to HCQ toxicity (e.g.,from abnormalities in the ABCA4 gene)Which is not~     studied previously among Egyptian population~   "
29553|NCT03180177|"~     This project is a multi-center, prospective, randomized controlled clinical observation the~     safety and efficacy of hyperthermic intraperitoneal chemotherapy as neoadjuvant~     chemotherapy(NACT) and postoperative chemotherapy after interval debulking surgery (IDS) for~     advanced-stage epithelial ovarian cancer . PR/SD rate, percentage of optimal debulking~     surgery and 3-year disease-free survival is the primary end points of this project.~   "
29554|NCT03180164|"~     Chronic airways diseases involve alterations in the person's social roles, relationships and~     self-perception so demands continual psychological adjustment .~      Also Kunik studied patients with chronic breathing disorders for depression and anxiety and~     found that 65% of patients were positive for depression and anxiety.~      Shackell found that patients' anxiety and fears of breathlessness and dying extended into the~     night and were aggravated by feelings of isolation and frustration. One patient reported that~     they often thought 'am I going to see the next morning?'~   "
29555|NCT03180151|"~     -  To compare patients who will undergo orthodontics treatment involving upper premolar~          extraction for space of time whether with or without corticotomy by Piezotome.~        -  Assess the safety of both methods of retraction in regard to the quality of the~          surrounding periodontium and roots of anterior teeth.~        -  Monitor postoperative pain.~   "
29556|NCT03180138|"~     Despite the impressive economic progress in developing countries, significant proportion of~     young children and pregnant women living in low-resource settings remain inadequately~     immunized. Progressive decline in immunizations are in large part attributable to poor~     follow-up and compliance. National and international pediatric bodies, recommend a time~     sensitive schedule for childhood immunizations, boosting immunity with each subsequent cycle,~     leading to adequate levels of immune protection. Due to inadequate protective immunity,~     resulting from poor vaccination compliance, outbreaks of vaccine-preventable diseases are~     rampant, making childhood mortality in this group among the highest in the world. Major~     challenges of vaccination programs include maintaining / tracking records, linked to positive~     identification of individual children, and strategies to improve follow-up and compliance.~     Novel cellular technology based approaches targeting behavior modifications can therefore~     significantly impact health outcomes in these communities. In this proposal, the~     investigators will evaluate a novel software platform, utilizing biometric identification of~     subjects, paired with cell-phone reminders and compliance-linked incentives to improve uptake~     and coverage of primary vaccinations in young children and pregnant women.~   "
29557|NCT03180125|"~     carpal tunnel syndrome (CTS) is the most common compression syndrome in the upper~     extremities, CTS is characterized by typical anatomic changes, the most probable swelling of~     the median nerve in the proximal part of the CT.~      Local infiltration of corticosteroids easily leads to atrophy of the median nerve,~     subcutaneous fat, and systematic complications, surgical treatment decision is always taken~     by the patient who sometimes wants to delay or avoid the surgery because of psychological or~     medical concerns, It would be interesting if low molecular weight sodium hyaluorinate~     injection is used as an alternative conservative treatment of CTS. This study aims to~     investigate if, and to what extent, hydro-dissection using 1% lidocain followed by injection~     of Sodium hyaluronate versus 1% lidocain followed by injection of 40 mg of triamcinolone~     acetonide, under ultrasound guidance.~   "
29558|NCT03180112|"~     Autism spectrum disorders are pervasive developmental disorders that include autistic~     disorder, Asperger's disorder, and pervasive developmental disorder-not otherwise~     specified.They are characterized by stereotypic behaviors, variable deficits in language and~     social skills and a wide range of other behavioral problems. Autism spectrum disorders~     manifest during childhood and at least thirty percent present with sudden clinical regression~     of development around three years of age.~   "
29559|NCT03180099|"~     Objectives:Lomber disc hernia is one of the most common diseases in Turkey. The prevalence in~     various studies is between 60-80% and incidence is between 1-3% for the entire~     population,Goal of TLIP is to provide a same impact in the thoracolumbar region, like~     thoracoabdominal plane block (TAP) diminish the pain in the abdominal surgery Methods: The~     study design was approved by the locale ethics committee. This double-blinded, randomized,~     controlled clinical trial recruited 50 patients who were candidated for surgical operations~     on lumbar disc hernia surgery. . Patients will be divided into two groups as Group T (TLIP~     block) and Group E (Epidural group).In group T, TLIP block will be applied before anesthesia~     and surgery and evaluate block efficiency with temperature discrimination and pin-prick test.~     During the TLIP block, block fluid will have total volume of 20 mL of 0.5% bupivacaine.). In~     Group E, after surgery, total of 20 ml of 0.1% bupivacaine and 50 mcg of fentanyl will be~     performed in the epidural space with direct vision by the surgeon.For the postoperative~     analgesia, patient controlled analgesia device will be administered as 20 mg/h continue dose~     tramadol and administered 10 mg bolus dose tramadol if patient need a rescue dose.~     Nausea-vomiting, tramadol consumption, bolus dose intervention and visual analog scale value~     in the postoperative 0-4., 4-12., and 12-24. hour interval will be assess and results will be~     record.~   "
29560|NCT03180086|"~     In a randomized controlled trial, the investigators will test the effect of a novel strategy~     for breast cancer risk assessment and risk-based management of women in their 40s seen in~     primary care. The investigators anticipate that this approach will lead to more optimal use~     of mammography screening and breast cancer prevention interventions in women in their 40s and~     as a result will improve care of these women.~   "
29561|NCT03180073|"~     Most of the conduction abnormalities with TAVR are usually detected during the procedure or~     during the following days of observation. Little is known about the prevalence and timing of~     any conduction abnormalities that exist before (other than standard ECG) or after through~     long term cardiac monitoring.~   "
29562|NCT03180060|"~     Background: Detection of coronary artery disease (CAD) is important due to its high~     prevalence and its medical and economic implications. Purpose: A systematic review of the~     diagnostic performance of stress echocardiography (Echo), SPECT, cardiac magnetic resonance~     (CMR), CT Perfusion (CTP) and PET versus invasive coronary angiography (ICA) or fractional~     flow reserve (FFR) using hierarchical summary ROC (HSROC) methods. Data Sources: MEDLINE,~     EMBASE and SCOPUS for literature published in English or Spanish from January 1970 to~     December 2015. Study Selection: For inclusion, studies had to meet the Cochrane guidelines,~     had to evaluate the sensitivity and specificity methods, and use ICA and/or FFR. Only those~     studies with STARD methodology ≥60% were included. Data Extraction: Ten investigators~     extracted patient and study characteristics and 4 resolved any disagreements.~   "
29563|NCT03180034|"~     Background:~      Certain types of human papillomavirus (HPV) cause almost all cases of cervical cancer.~     Vaccines that protect against HPV can substantially reduce the risk of cervical cancer.~     However, HPV vaccination rates are too low, especially in countries with very high rates of~     cervical cancer. HPV vaccines are expensive-many countries cannot afford them-more than one~     dose is needed, and giving multiple doses is difficult. Researchers want to find out if one~     dose prevents HPV infection. If it does, more people might get the vaccine.~      Objective:~      To find out if giving only one dose of either the Cervarix or Gardasil9 HPV vaccines work the~     same as giving two doses of these vaccines to young women.~      Eligibility:~      Females ages 12-20 who live in Costa Rica.~      Design:~      There are two components to the study: (1) a controlled, randomized, double-blinded~     non-inferiority clinical trial to compare one-dose to two-dose vaccination; and (2) a~     concurrent epidemiologic survey for HPV status among unvaccinated women.~      The trial will enroll twenty thousand girls 12 to 16 years old residing in Costa Rica.~     Participants will be randomized in two stages to one of four arms (one dose of the bivalent~     vaccine, two doses of the bivalent vaccine, one dose of the nonavalent vaccine and two doses~     of the nonavalent vaccine); the first randomization at enrollment will assign participants to~     one of the two study vaccines and at the second visit they will be randomized to one or two~     doses. Girls randomized to the one dose arm will receive an active control (i.e.: Tdap) at~     the time of the second vaccine dose. After vaccination, girls will be followed every six~     months for four years.~      The epidemiologic HPV survey will enroll a group of unvaccinated girls from the same~     geographic areas; they will range in age from 17 to 20. These women will attend two study~     visits six months apart to determine their HPV DNA status, there will be no additional~     followup. These women will be offered HPV vaccination at the enrollment and six-month study~     visits.~      At each visit, participants will fill out a questionnaire and give a urine sample. They may~     give blood samples. The older participants will use a swab to collect cervical cells from~     their vagina....~   "
29564|NCT03180021|"~     To use a variety of renal imaging modalities, including diffusion weighted imaging (DWI),~     blood oxygen level dependent (BOLD) imaging, T1rho (T1rho) imaging, and dynamic contrast~     enhanced magnetic resonance imaging (DCE-MRI) to evaluate the intra-renal blood flow,~     perfusion, cellularity, fibrosis and atrophy within the kidneys of patients with lupus~     nephritis (LN) and compare these parameters to renal biopsy findings to determine whether~     DWI, BOLD, T1rho, and DCE-MRI may provide a set of non-invasive tools to assess renal~     function and pathology in LN.~   "
29565|NCT03180008|"~     This randomized controlled trial is comparing outcomes of customary Fit and Strong!, to Fit~     and Strong! Plus, an enhanced version of the program that incorporates weight management. We~     hypothesize that Fit and Strong! Plus participants will show improved diet behaviors at 2, 6,~     12, and 18 months that will be accompanied by a significant 5% weight loss at 6 months and~     maintained to 18 months, compared to participants in customary Fit and Strong!.~   "
29566|NCT03179995|"~     This will be a prospective, randomized, double blind trial enrolling patients who will~     undergo major liver resection. Patients will be randomized in a 1:1 ratio to receive either~     octreotide or placebo in the postoperative period. The patients will receive octreotide~     intravenously continuously for five days after operation. During this period the patients'~     health will be monitored by performing blood tests including complete metabolic profile,~     Complete Blood Count (CBC) with/diff., INR and PTT. The functioning of heart will also be~     monitored post-operatively by EKG. Up to 80 participants will be accrued over a 2 year~     period. Volumetric CT scans will be performed prior to hepatectomy, 1 week after hepatectomy~     and 3 months after hepatectomy to evaluate liver regeneration.~   "
29567|NCT03179982|"~     The purpose of this study is to test the feasibility and acceptability of Safe South Africa,~     an integrated intervention for preventing HIV and Intimate Partner Violence perpetration for~     male adolescents 15-17 years of age.~   "
29569|NCT03179956|"~     A window of opportunity study which would allow brief treatment of HPV negative SCCHN with a~     CDK4/6 inhibitor, in the pre-operative setting, with biomarker analyses of pre and post~     treatment tissue. Given that the standard treatment for this population is surgical~     resection, this would not impact or alter standard therapy for this population. The goal will~     be to learn more about the alterations in pRB1 levels, as well as other signaling markers, in~     order to be able to eventually plan a biomarker driven treatment study.~   "
29570|NCT03179943|"~     This is a single arm Phase II study with a safety run-in to identify the recommended phase II~     dose of the combination therapy of atezolizumab and guadecitabine. Patients with~     recurrent/advanced urothelial carcinoma (stage IV) who had previously progressed on~     check-point inhibitor therapy with PD-1 or PD-L1 targeting agents are eligible for this~     study. After a dose that is safe and tolerable has been established, a dose expansion phase~     (Phase II) will begin. This study will enroll a total of 4 to 53 patients depending upon the~     number of patients treated in the safety run-in phase and the number of subjects replaced~     during the phase II portion.~   "
29571|NCT03179930|"~     The purpose of this study is to test any good and bad effects of the study drugs called~     Pembrolizumab and Entinostat when used in combination to treat lymphoma. This combination~     could shrink the lymphoma but it could also cause side effects. Researchers also hope to~     learn whether adding entinostat to pembrolizumab can be more effective for patients with~     lymphoma than either drug alone.~   "
29572|NCT03179917|"~     This study is being done to test the safety and effectiveness of pembrolizumab followed by~     radiation therapy in Hodgkin lymphoma.~      The purpose of this study is to determine how effective combining the research drug,~     pembrolizumab, with a targeted form of radiation therapy known as involved site radiotherapy~     can be in patients with relapsed or refractory early stage classical Hodgkin lymphoma. The~     goal is to see whether this treatment strategy can cure a significant number of patients with~     relapsed or refractory early stage classical Hodgkin lymphoma while avoiding the toxicity of~     either a large radiation field or further chemotherapy and stem cell transplant.~   "
29573|NCT03179904|"~     This phase II trial studies how well FASN inhibitor TVB-2640, paclitaxel, and trastuzumab~     work in treating patients with HER2 positive breast cancer that has spread to other places in~     the body. FASN inhibitor TVB-2640 may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and~     trastuzumab, work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Giving FASN~     inhibitor TVB-2640, paclitaxel, and trastuzumab may work better in treating patients with~     HER2 positive breast cancer.~   "
29574|NCT03179891|"~     The hypothesis of this study is that DBSF will be safe whether it is given when subjects are~     not experiencing seizures (Interictal Period A) or experiencing active seizures~     (ictal/peri-ictal Period B), and that Pharmacokinetic (PK) is not different during or in~     between the seizures.~   "
29575|NCT03179878|"~     A Phase 1, First-in-human, Oral Single and Multiple Dose-Escalation, Randomized,~     Double-blinded, Placebo-controlled Study of SYNB1020 in Healthy Adult Volunteers to Evaluate~     Safety, Tolerability, Dosing, and Pharmacodynamics~   "
29576|NCT03179865|"~     Establishing that mucosal healing (MH) has occurred after therapy is an important treatment~     goal, and the gold standard is endoscopic evaluation. In UC it is unclear if clinical~     parameters are adequate. The pediatric ulcerative colitis activity index (PUCAI) has~     demonstrated good correlations for clinical remission and disease severity, but its role for~     establishing mucosal healing after therapy has not been validated . The ability to predict~     mucosal healing may be different for patients in long term remission compared to assessment~     after obtaining clinical remission. No previous study has prospectively validated the use of~     PUCAI as a proxy for MH specifically during clinical remission after therapy.~   "
29577|NCT03179852|"~     The primary objective is to assess pre- and post-intervention nutrition education knowledge~     and preference. The secondary objective is to assess pre- and post-intervention fruit and~     vegetable consumption via a plate waste study.~   "
29578|NCT03179839|"~     The primary objective of the study is to evaluate the clinical curative effect of MBCT to~     reduce obsessive and compulsive symptoms. Moreover, the investigators will also explore a~     MBCT manual for Chinese patients with OCD, which can be widely applied to the clinical~     practice.~      There are two parts of the study. The first part is a qualitative research with two pilot~     MBCT groups. The second part of this study is a single-blind randomized controlled trial with~     three study arms: one - third of participants receive group mindfulness-based cognitive~     therapy led by trained MBCT psychotherapists or psychiatrists in addition to medication, one~     - third of participants receive group psycho-education program and one - third of~     participants receive drug therapy as usual. All participants have 10 sessions intervention~     and assessments.~   "
29579|NCT03179826|"~     Chronic obstructive pulmonary disease (COPD) and asthma are frequent and disabling~     pathologies. The general practitioner is often at the front line vis-a-vis screening,~     diagnosis and treatment of these pathologies. There are currently many treatments available,~     in particular inhaled corticosteroids, and although the recommendations for management appear~     to be well codified in theory, the adaptation of drug therapy remains complex in general~     practice.~      The prescription of inhaled corticosteroids, often initiated during a general medicine~     consultation, is not simple. The aim of this study is to analyze the relevance of the~     prescription of inhaled corticosteroids in primary care and to identify the criteria~     necessary for the prescription of inhaled corticosteroids available in general practice.~      The main objective of our study is to evaluate the rate of consultations where all the~     elements required for guiding the prescription of an inhaled corticoid are available.~      The secondary objectives are:~        -  Identify other factors associated with decision-making~        -  Identify the causes of inhaled corticosteroid stopping (de-prescription)~   "
29580|NCT03179813|"~     The investigators set out to develop a clinical trial in order to test the topical use of~     hydrocortisone as a intraoperative irrigant solution. As this route of administration as well~     as being low cost and not add new steps to the surgical procedure, can contribute to an~     improved quality of life in the postoperative period of patients undergoing extraction of~     third molars.~   "
29581|NCT03179800|"~     The objective of this study is to evaluate the safety and effectiveness of the MobiusHD~     System in a prospective, randomized, double-blind, sham-controlled multi-center pivotal~     study.~   "
29584|NCT03179761|"~     This randomized phase II studies the side effects of high-dose trivalent influenza vaccine or~     standard-dose quadrivalent inactivated influenza and how well they work in treating adult~     patients undergoing stem cell transplant. Season influenza can cause more severe infections~     in patients who have had a stem cell transplant since their immune system doesn't work as~     well. Influenza vaccine may provide better protection against flu in adults.~   "
29585|NCT03179748|"~     The trial is conducted in North America. The aim of the trial is to assess the safety of~     turoctocog alfa under conditions of routine clinical care in patients with haemophilia A in~     Mexico~   "
29586|NCT03179735|"~     The number of orthodontic treatment provided to Brazilian population has been increased.~     Unfortunately, some negative effects such as gum bleeding and bad breath are commonly~     observed. It partially happens because tooth brushing and flossing become more difficult in~     the presence of braces. Therefore, there is a need for clinical protocols able to maintain~     the mouth healthy during orthodontic treatment.~      Considering that proper use of mouthwashes by in individuals without braces is accompanied by~     decrease in plaque and gum inflammation levels, it was hypothesized that, during orthodontic~     treatment their anti-gingivitis and anti-plaque properties would positively affect oral~     health. Objectives: The present study will compare the effects of two commercially available~     mouthwashes with a placebo mouthwash in orthodontic patients wearing fixed appliances.~      Whole-mouth clinical examinations will be performed in periodontally healthy patients 15 days~     before, at the day of bonding and also 3 and 6 months after braces bonding. Hard and soft~     tissues status, presence of gingivitis and amount of dental plaque will be monitored to~     determine mouthwashes efficacy. At these same time-points plaque samples will be collected~     from dental sites and braces surfaces aiming at determining total levels of bacteria and~     levels of specific bacteria related to gum disease. After a full-mouth ultrasonic debridement~     to remove dental plaque, stains and tartar, patients will be randomly assigned to an~     Essential oils, Cetylpyridinium chloride or a placebo mouthwash for 6 months (40 ml/day).~     Further, samples of orthodontic wires will be analyzed under microscopy to check whether~     regular use of mouthwashes increases the risk of corrosion or not.~   "
29587|NCT03179722|"~     In this intervention study, 75 Belgian community pharmacies each recruit 12 patients for an~     intermediate medication review. For each patient, the identified drug-related problems and~     subsequent interventions are registered using the PharmDisc classification. In a subset of~     Dutch speaking patients, a pretest-posttest single group design is used to measure the impact~     of this review on patient related outcomes using questionnaires. The primary outcome is the~     medication related quality of life, measured via the living with medicines questionnaire.~     Other patient reported outcomes include adherence, self-management, patient satisfaction,~     fall incidents and use of emergency healthcare services. Medication records are also~     collected to objectively measure adherence before and after the intervention.~   "
29588|NCT03179709|"~     The proposed study will use qualitative methodology to understand health care provider~     perceptions of neuromuscular blockade (NMB) in patients with Acute Respiratory Distress~     Syndrome (ARDS). To achieve this goal the investigators will conduct a prospective ancillary~     study at four clinical centers participating in the NHLBI PETAL network as part of the ROSE~     (Reevaluation of Systemic Early Neuromuscular Blockade) clinical trial (NCT02509078). Using~     thematic content analysis of semistructured interviews with health care providers caring for~     patients enrolled in the ROSE trial the investigators will determine the barriers to NMB use~     and develop a framework for future NMB adoption in ARDS.~   "
29589|NCT03179696|"~     This clinical trial will test a combined group therapy plus mobile cognitive behavioral~     therapy intervention targeting defeatist attitudes in consumers with schizophrenia in order~     to change motivational negative symptoms linked to defeatist attitudes.~   "
29590|NCT03179683|"~     This randomized controlled split-mouth clinical trial study was designed to evaluate the~     effects of low-level laser therapy on bone healing in patients with bilateral sinus lifting~     and simultaneous dental implant application.~      Maxillary posterior partially edentulous or totally edentulous twelve patients who need~     bilateral sinus bone augmentation were included in this study. Sinus bone augmentation and~     dental implant surgeries were done simultaneously. Low level laser therapy (LLLT) was (λ=~     630-660 nm, 25 mw / cm², 6 mins) applied for just one operation side at first, third, fifth~     and seventh days. Treatment side were randomly selected by another surgeon who applied LLLT.~     Panoramic radiographs were taken at the first, third and sixth months using aluminum~     step-wedge technique. Optic Density analyses were performed using Cardinal Health Digital~     Densitometer (Fluke Biomedical 07-443) with 1mm diameter. Digital densitometric results were~     obtained as equivalent aluminum thickness for each radiograph. These data were used to~     evaluate changes in optical bone densitometry and compare the LLLT applied side and control~     side for each patient.~   "
29591|NCT03179670|"~     The high level of unsatisfactory outcome observed in patients treated for LUTS associated~     with BPH with respect to the different existing therapeutic options strongly emphasizes the~     need for treatment optimisation in daily practice by a careful LUTS monitoring and treatment~     adjustment when needed. The poorer outcome observed in patients for whom treatment has been~     initiated recently suggests that the duration of the disease itself may influence the patient~     satisfaction.To achieve this goal, we propose to systematically assess LUTS associated with~     BPH in patients treated for at least 6 months and to assess whether an alpha-blocker therapy~     initiation/modification may improve the outcome in case of persisting symptoms. We also~     investigate the influence of the symptom duration on the frequency of unsatisfactory outcome.~   "
29610|NCT03179423|"~     The monoclonal antibody GNbAC1 targets the envelope protein (Env) of the human endogenous~     Multiple Sclerosis associated RetroVirus (MSRV), which could play a critical role in~     different autoimmune disorders, notably type 1 diabetes (T1D).~      This study is a multicentre study evaluating for the first time the safety and efficacy of~     GNbAC1 in T1D subjects for a first bouble-blind period of 20 weeks followed by an optional~     open-label period of 24 weeks. The primary objective of the study is to assess the safety and~     tolerability of six consecutive 4-weekly doses of GNbAC1 in subjects with T1D. Secondary~     objectives are to determine the pharmacodynamic response to GNbAC1 on biomarkers of T1D.~   "
31185|NCT03158870|"~     Collaboration between the surgeon and the anesthesiologist is key for delivering a safe~     pheochromocytoma surgery. This study aims to establish the collective performance of~     surgeon-anesthesiologist team by quantifying the relationship between their previous~     collaborations and patient complications.~   "
29592|NCT03179657|"~     Purpose: The Guangzhou Nutrition and Health Study (GNHS) aims to assess the determinants of~     risk of osteoporosis and cardio-metabolic diseases and changes in their relevant indices in~     nutritional aspects, as well as other environmental and genetic factors.~      Study design: GNHS is a community-based prospective cohort study.~      Participants: About 4540 apparently healthy residents, living in Guangzhou city (South China)~     for >5 years, aged 40-80 years, recruited between 2008 and 2013.~      Visits and Data Collection: Participants were/will be visited every three years by invited to~     the School of Public Health, Sun Yat-sen University. At each visit, face-to-face interviews,~     specimen collection, anthropometric measurements, DXA scanning, ultrasonography evaluation~     were/will be conducted. Up to May 2017, 3400 and 2380 subjects completed the 2nd and 3rd~     visits.~      Key variables:~        1. Questionnaire interviews: Structured questionnaires were/will be used to collect the~          participants' socio-demographic characteristics, lifestyle factors, menstruation and~          reproductive history (women only), sleep quality, family history, psychological health,~          social support and participation, cognitive function, habitual dietary intake, use of~          supplements and history of chronic diseases.~        2. Physical examinations: Anthropometric measurements, blood pressure tests, handgrip~          strength, and usual gait speed.~        3. DXA scanning: A dual-energy x-ray absorptiometry (DXA) was/will be used to determine~          bone density and bone mineral content, bone geometry information, fat mass and muscle~          mass.~        4. Ultrasonography evaluations: Ultrasonography evaluation was/will be performed to~          determine carotid artery intima-media thickness and plaque, and fatty liver.~        5. Specimen collections: Overnight fasting blood sample and early morning first-void urine~          sample and faces samples were/will be collected, separated and stored at −80°C till~          tests.~        6. Laboratory tests:~             1. Blood tests: Metabolic syndrome-related indices; inflammatory markers; sexual~               hormones and SHBG; genetic markers; nutritional indices (e.g., carotenoids; fatty~               acids; minerals, folate, betaine, choline, and vitamin D, etc.)~             2. Urinary tests: Flavonoids and flavones; minerals; creatinine and renal function~               related markers~             3. Fecal test: Gut microbiota and related metabolites.~        7. Morbidity and mortality: Relevant data were/will be also retrieved via local multiple~          health information systems.~   "
29593|NCT03179644|"~     The primary objective of the study is to determine the correlation between mean pleural~     pressure and oesophageal pressure in the immediate aftermath of bi-pulmonary transplantation.~      In this research, oesophageal pressure will be measured by a nasogastric tube with an~     esophageal balloon (also suitable for feeding the patient) usually installed at the time of~     transplantation, pleural pressure will be measured by several Pleurocath-type catheters~     (Prodimed Inc, France) which the thoracic surgeon will have positioned at the end of the~     surgery without additional skin intrusion.~   "
29594|NCT03179631|"~     This study is a long-term study of ataluren in patients with nonsense mutation Duchenne~     muscular dystrophy.~   "
29595|NCT03179618|"~     This study evaluates the clinical efficacy of Xuefu Zhuyu Decoction in the treatment of~     unstable angina pectoris. All of the patients will be divided into 2 arms randomly. One of~     the arms will be treated by conventional western medicine, the other one will be treated by~     Xuefu Zhuyu Decoction at the base of conventional western medicine.~   "
29596|NCT03179605|"~     The purpose of this study is to evaluate the potential of DFD-06 to suppress the~     hypothalamic-pituitary-adrenal (HPA) axis when applied twice daily for 15 days.~   "
29597|NCT03179592|"~     The purpose of this study is to prospectively evaluate the effectiveness of low-volume~     contrast media (CM) injection protocols adapted to tube voltage in patients undergoing~     Coronary Computed Tomography Angiography (CCTA).~   "
29598|NCT03179579|"~     This project is a multi-center, prospective, randomized controlled clinical observation the~     safety and efficacy that stage IV limited peritoneal metastasis of gastric cancer patients~     accept hyperthermic intraperitoneal chemotherapy plus neoadjuvant chemotherapy with CRS and~     systemic chemotherapy. With advanced-stage gastric patients of confined to the peritoneal as~     the research object, with median progression-free survival and overall survival, adverse~     events as the end points.~   "
29599|NCT03179566|"~     Patients will be randomized to one of two interventions intended to facilitate safe disposal~     of opioids after cessation following surgery. For pragmatic reasons, participants will be~     randomized by day to either the information sheet or the disposal bag using a block~     randomization schedule. To ensuring adequate sample size, patients will be enrolled for a~     ~4-week period following the 2-week usual care run in period. In the event that the sample~     size estimate has not been reached after the 4-week intervention period, additional patients~     will be enrolled accordingly.~   "
29600|NCT03179553|"~     This study will find out if analysing heartbeat in babies with brain injury, based on~     standard clinical monitors, can inform treatment decisions and monitor stress levels in real~     time~   "
29601|NCT03179540|"~     This is a 5 year Phase II study to evaluate the safety of non-operative management (NOM) in~     patients with low rectal cancer (LRC) who achieve a complete clinical response (cCR)~     following chemoradiotherapy (CRT). The safety of NOM will be evaluated by assessing (i) rate~     of local re-growth and (ii) rate of macroscopically positive resection margin (R2) when~     surgery is required due to local re-growth. NOM will be considered safe or as effective as~     surgery to achieve local control if the rate of local re-growth is equal to or less than 30%~     and the rate of a macroscopically positive margin is 0%.~   "
29602|NCT03179527|"~     This study evaluates the clinical efficacy of Shuanghe Decoction in the treatment of unstable~     angina. All of the patients will be divided into 2 arms randomly. One of the arms will be~     treated by conventional western medicine, and the other one will be treated by Shuanghe~     Decoction at the base of conventional western medicine.~   "
29603|NCT03179514|"~     This study evaluates the clinical efficacy of Gualou Xiebai Banxia Decoction compounded with~     Danshen Decoction in the treatment of unstable angina pectoris. All of the patients will be~     divided into 2 arms randomly. One of the arms will be treated by conventional western~     medicine, the other one will be treated by Gualou Xiebai Banxia Decoction compounded with~     Danshen Decoction at the base of conventional western medicine.~   "
29604|NCT03179501|"~     This is a Phase 1 placebo-controlled biomarker study of NP001 in individuals with Alzheimer's~     Disease.~   "
29605|NCT03179488|"~     The intensity used during transcutaneous electrical nerve stimulation (TENS) in both,~     clinical practice and research studies, is often based on subjective commands such as strong~     but comfortable sensation. There is not consensus regarding the effectiveness dose of TENS~   "
29606|NCT03179475|"~     The study will be investigating the effectiveness of oxycodone-naloxone (brand name Targin®)~     at treating chronic pain in individuals with spinal cord injury. The goal of the study is to~     compare the effectiveness of Targin® at treating chronic pain in individuals with sub-acute~     and chronic spinal cord injury compared to opioid medication that is not compounded with~     naloxone.~   "
29607|NCT03179462|"~     The investigators will examine the effects of a given amount of a protein food source such as~     pork, mixed nuts, and tofu on anabolic response at the whole body and muscle levels in young,~     healthy adults.~   "
29611|NCT03179410|"~     The purpose of this study is to assess the safety and efficacy of avelumab in patients with~     metastatic neuroendocrine-like prostate cancer. Eligible men will be started on avelumab~     every 2 weeks and will stay on therapy until progression or intolerable side effects. The~     central hypothesis is that PD-L1 inhibition with avelumab will be efficacious based on~     radiographic responses in a subset of men with metastatic neuroendocrine-like prostate cancer~     and be reasonably well tolerated, meeting criteria for further study in larger phase 2 and 3~     trials based on meeting pre-specified efficacy rates and prolonged PFS in some men.~   "
29612|NCT03179397|"~     To evaluate the Model SC9 Intraocular Lens for the improvement of near and intermediate~     vision when compared to a legally marketed monofocal IOL.~   "
29613|NCT03179384|"~     Acute pyelonephritis (APN) corresponds to infections of the renal parenchyma. The annual~     incidence of these infections is estimated at 4-6 million cases in France, with 60 to 90% of~     patients managed in general city medicine. The ceftriaxone, parenteral third-generation~     cephalosporin (C3G), occupies an important place in the antibiotic treatment of these~     infections: this is the recommended probabilistic treatment, and in some situations the~     treatment can be continued in its entirety via a Ceftriaxone monotherapy.~      The aim of the last antibiotic plan is to avoid the use of antibiotic therapies with a high~     selection capacity (cephalosporins, penicillins, fluoroquinolones, etc.) and thus reduce the~     incidence and prolongation over time of the digestive carriage of multi-resistant bacteria .~      To date, there have been few studies evaluating the impact of ceftriaxone on the emergence of~     multi-resistant bacteria on an individual scale, with rather heterogeneous results (13-86%~     C3G resistance).~      Thus, before considering randomized studies comparing the ecological impact of different~     molecules or therapeutic regimens in the treatment of ANP, it is necessary to have a precise~     and rigorous evaluation of the ecological impact of the molecule reference in this~     indication.~      The investigators propose a study to evaluate the impact on the digestive flora at 1 month of~     a ceftriaxone antibiotic therapy (7 days) in the management of acute pyelonephritis in women.~   "
29614|NCT03179371|"~     Congenital diaphragmatic hernia (CDH) is a severe congenital malformation, related to a~     developmental defect of the diaphragm. The incidence of CDH is approximated at 1 in 3,000~     live births. Although advances in surgery and neonatal intensive care have improved the~     prognosis, mortality remains high, around 30-50% related to severe lung hypoplasia and~     persistent pulmonary hypertension. Prenatal evaluation with observed/expected Lung over Head~     Ratio (o/e LHR), liver position and total lung volume measured by magnetic resonance, have~     been shown to correlate with neonatal mortality . However, the preponderant factor of~     persistent pulmonary hypertension remains difficult to predict prenatally. In patients with~     isolated diaphragmatic hernia (without associated malformations or karyotype abnormalities),~     prognosis is evaluated indirectly on pulmonary development from pulmonary volume~     measurements. Apart from the most caricatural cases with extremely good or very pejorative~     values, for a large proportion of fetuses with diaphragmatic dome hernia the prognosis~     remains uncertain.~      The aim of the proposal is to investigate whether the analysis of the proteom of the amniotic~     fluid of the fetuses with CDH could give information of a prognostic character. The objective~     of the study is to identify, from the proteomic profile of the amniotic fluid of mothers~     whose fetus has CDH, prognostic markers candidates for death at 2 months of the infant. The~     first step is to carry out an exploratory and non-interventional study on a small sample (n =~     10) of the target population. This is a preliminary step before considering, if the results~     are encouraging, a large-scale study from a biological collection to determine candidate~     proteins (new biomarkers) which relative expression levels could be used as surrogate marker~     of pulmonary hypoplasia.~   "
29615|NCT03179358|"~     In colorectal surgery, hand suturing and stapling are routine methods for performing~     intestinal anastomoses, and these methods appear to be similar in terms of clinical safety.~     Despite several years of experience with surgical procedures as well as improvements to the~     medical devices, problems with disturbed anastomotic healing leading to leakage and stenosis~     after colorectal surgery remain a significant challenge for surgeons. In addition,~     preoperative radiotherapy has been shown to increase the risk of anastomotic leakage even~     further.~      The methods that are used today to detect leakages are unfortunately inaccurately and limited~     to monitoring symptoms, temperature, CRP (C-reactive protein)-levels, and performing~     abdominal examinations and CT-scans. These clinical signs and parameters usually become~     apparent several days after onset of the leakage, which leads to a delayed diagnosis.~     Anastomotic leakage is not only a significant cause of increased morbidity of complications~     and mortality in patients, but also associated with increased risk of local recurrence and~     poor prognosis. Moreover, when reoperation is required to fix the leakage, a permanent stoma~     may be made at the level of the sigmoid colon and this procedure impacts quality of life~     negatively.~      Based on the above considerations, a novel, adaptive anastomotic method has been developed by~     CarpoNovum to achieve a safer anastomosis. The method's working name is C-REX Ring-locking~     Procedure (C-REX is referred to our Colorectal anastomotic rings for Re-join the intestinal~     ends and validate the anastomosis, with function of Extract samples for analysis and conduct~     X-ray through connected catheters).~      The novel adaptive anastomotic medical devices, C-REX LapAid and C-REX DMH/DMHC are easy to~     use, with unique possibility to control the anastomosis during and after surgery. The~     previous successful preclinical study encourages a clinical verification in patients~     undergoing colonic resection to evaluate the safety and performance of C-REX Ring-locking~     Procedure by use of C-REX LapAid and C-REX DMH/DMHC.~   "
29616|NCT03179345|"~     Phase 4, double-blind, placebo-controlled, four treatment, four sequence crossover study~     comparing simulated driving performance, daytime sedation and cognition in healthy volunteers~     administered therapeutic doses of Gralise® (Treatment A), Neurontin® (Treatment B), Lyrica®~     (Treatment C) and placebo (Treatment D). All doses were administered under fed conditions.~   "
29617|NCT03179332|"~     This is a single-centre, randomised, double-blind, three-period, complete cross-over trial~     comparing the pharmacokinetic and the pharmacodynamic properties of BioChaperone® insulin~     lispro and the two active comparators Fiasp® and Novorapid® when given as a bolus on top of~     basal delivery with an insulin pump in subjects with type 1 diabetes mellitus. Each subject~     will be randomly assigned to a treatment sequence consisting of 3 dosing visits during which~     the subject will receive the investigational products. In a euglycaemic clamp setting,~     subjects will be given a bolus dose of 0.15 U/kg body weight.~      Throughout the glucose clamp procedure, blood glucose will be stabilised at a target level of~     100 mg/dL by means of an intravenous infusion of glucose. Blood samples for pharmacokinetic~     assessment will be drawn at specified timepoints and glucose infusion rates and blood glucose~     concentrations will be recorded for pharmacodynamic assessment during the 10-hour clamp~     procedure after dosing.~   "
29618|NCT03179319|"~     This study is testing the acceptability and feasibility of MyChoices, a mobile application~     (app), to promote HIV testing and pre-exposure prophylaxis (PrEP) uptake among young men who~     have sex with men (YMSM).~   "
29619|NCT03179306|"~     The Clinical Epidemiology Unit in the Clinical Genetics Branch of the Division of Cancer~     Epidemiology, NCI has a strong interest in fostering cervical cancer prevention solutions for~     all kinds of settings, including lowresource ones that rely on development of robust,~     low-cost screening and triage tools. Therefore, to support development of algorithms for~     cervical image recognition software, NCI seeks to share digital cervical images and~     accompanying clinical data from our large epidemiological studies on HPV and cervical cancer~     screening with interested and qualified image analysis researchers. To accommodate the many~     researchers that are interested, we have created this standard protocol to describe a unified~     process for sharing deidentified cervical images and accompanying de-identified clinical data~     from the following NCI studies: Costa Rican Natural History Study of HPV and Cervical~     Neoplasia , ASCUS LSIL Triage Study-- ALTS , SUCCEED and Costa Rica Vaccine Trial .~   "
29620|NCT03179293|"~     The aim of this randomized double-blinded study is to determine whether transition to~     propofol for 3 min at the end of sevoﬂurane anaesthesia reduces the incidence of EA in~     children undergoing genito-urinary paediatric surgeries.~   "
29621|NCT03179280|"~     A study was conducted in adolescents with type 1 diabetes (T1D) examining the effect of~     different bolus types on 6-h postprandial glucose levels after the consumption of 3 standard~     meals with varying composition. Participants were asked to consume 10 different combinations~     of meal and bolus type.~   "
29622|NCT03179267|"~     In recent years there has been increasing focus on the earlier detection of deterioration in~     the clinical condition of hospital patients with the aim of instigating earlier treatment to~     reverse this deterioration and prevent adverse outcomes. This is especially important in the~     ED, a dynamic environment with large volumes of undifferentiated patients, which carries~     inherent patient risk. SNAP40 is an innovative medical-grade device that can be worn on the~     upper arm that continuously monitors patients' vital signs including relative changes in~     systolic blood pressure, respiratory rate, heart rate, movement, blood oxygen saturation and~     temperature. It uses automated risk analysis to potentially allow clinical staff to easily~     and quickly identify high-risk patients. The aim of this study is to investigate whether the~     SNAP40 device is able to identify deterioration in the vital sign physiology of an ED patient~     earlier than current standard monitoring and observation charting techniques.~   "
29623|NCT03179254|"~     Patients scheduled to undergo ambulatory surgery are usually made non per os (NPO) at~     midnight on the day prior to surgery. In the case of patients with type 2 diabetic mellitus~     (DM) on treatment with oral hypoglycemic agent (OHA), patients are instructed to temporarily~     discontinue treatment on the day prior to surgery. This advice is based on the concern for~     intraoperative and postoperative hypoglycemia in this group of patients. Metformin , a~     dimethylbiguanide, is widely used as an oral antihyperglycemic drug in the long term~     treatment of type 2 DM. This instruction to withhold treatment may be imprudent given that~     metformin by virtue of its mechanism of action does not cause hypoglycemia. Another concern~     often cited as a reason to withhold metformin is the reported adverse effect of lactic~     acidosis. However, a recent metanalysis by the Cochrane group found no cases of fatal or~     nonfatal lactic acidosis in 70,490 patient-years of metformin use, or in 55,451 patient-years~     for those not on metformin. Furthermore, discontinuing OHA treatment can result in disruption~     of established glycemic control and intraoperative and postoperative hyperglycemia all of~     which can be deleterious to the patient.~      We hypothesize that uninterrupted treatment with OHA in type 2 DM patients undergoing~     ambulatory surgery will not result in intraoperative and postoperative hypoglycemia (defined~     as blood glucose < 60mg/dl) compared to patients withholding OHA treatment on the day of~     surgery.~   "
29624|NCT03179241|"~     Selektive dorsal rhizotomy (SDR) has been used as treatment option in children suffering from~     cerebral palsy (CP) for several decades and multiple studies demonstrated its benefits.~     Nevertheless, there are still no proven strategies for patient selection, optimal point of~     time for the operation or pre- and postoperative therapies. The evaluation of the impact of~     selective motor control, cognition and cerebral imaging findings on the motor outcome and~     life quality in children with CP who underwent SDR at the Charité University clinics will~     clarify these critical points in daily care for patients with CP.~   "
29625|NCT03179228|"~     The primary study objective is to evaluate improvement of symptoms from benign prostatic~     hyperplasia (BPH) as assessed by the International Prostate Symptom Score (IPSS) at 12 months~     post prostatic artery embolization (PAE) with bland microspheres.~   "
29626|NCT03179215|"~     Correction of arterial hypotension is essential for adequate cellular metabolism. maintaining~     MAP above a minimum level has been recommended in order to prevent further tissue~     hypoperfusion and organ dysfunction.Functional assessment of arterial load by dynamic~     arterial elastance (Eadyn), has recently been shown to predict the arterial pressure response~     to volume expansion (VE) in hypotensive, preload-dependent septic patients.~   "
29627|NCT03179202|"~     The purpose of this study is to evaluate the safety and effectiveness of electrical~     stimulation (low levels of electricity) on low back pain. This study involves a Peripheral~     Nerve Stimulation (PNS) system. The System delivers mild electrical stimulation to the~     muscles in the low back. The System includes up to four small wires (called Leads) that are~     placed through the skin into the muscles in the low back. It also includes up to four devices~     worn on the body that deliver stimulation (called Stimulators).~   "
29628|NCT03179189|"~     The pathophysiology and treatment of sepsis disease are still not fully known. International~     guides often refer to the studies done in the developed countries and suggest some~     treatments. The infrastructure of the developing countries is quite different. For this~     reason, it is not exactly scientific how much these proposals are reflected in patient~     treatment. In our study, We will try to reveal the treatment of sepsis.~   "
29648|NCT03178929|"~     The aim of this study is to explore the effect of SAMe on recurrence after radical treatment~     of Primary liver cancer.~   "
29649|NCT03178916|"~     The American Academy of Paediatrics recognizes multiple benefits of breastfeeding to both the~     term and premature newborn, particularly with regard to protection from infectious agents.~     Studies have demonstrated decreased rates of bacteraemia, meningitis, respiratory and urinary~     tract infections, necrotizing enterocolitis, and otitis media among breastfed infants~   "
31227|NCT03158324|"~     This is a phase IIa open-label, non-randomized dose-expansion study of OPB-111077 in patients~     with advanced, treatment refractory cancers who have biopsy-amenable lesions at study entry.~   "
29629|NCT03179176|"~     In brain tumor surgery we are confronted mainly with two types of difficulties: (i) the~     identification of the tumor and its limitations in relation to the healthy brain; (ii) the~     identification of functional cerebral regions, ie implicated in neurological function (motor~     skills, sensitivity, language, vision, cognition, etc.). The reference method currently used~     to improve the quality of resection of brain tumors while minimizing neurological risk for~     patients is so called wakeful surgery with direct electrical stimulation (DES) of the~     brain. The investigators routinely use ultrasound to localize the tumor within the brain, but~     to date there is no pre- or intra-operative imaging tool to reliably identify tumors and~     functional brain regions. There is therefore a need for innovative imaging in this field.~      For this reason, the investigators propose to evaluate the interest of a new High Frequence~     Ultrasound Doppler (HFUD) (VEVO ®, Visualsonics, Toronto, Canada) in the surgical management~     of patients operated in an awake condition for a brain tumor. The ultra high frequency allows~     to reach a spatial resolution of 30 μm, 5 to 10 times better than MRI and conventional~     ultrasound. The Doppler mode allows the detection of microvascular flows of speeds less than~     1 mm / second. The safety of this device is demonstrated and validated by CE marking~     (December 2015).~   "
29630|NCT03179163|"~     High blood pressure can cause physical changes to the blood vessels of the body (remodeling).~     If a person who has high blood pressure also has a lot of blood vessel remodeling with their~     condition, they are more likely to have poor results with medical treatment for hypertension.~     The researchers examine the impact of different classes of drugs that doctors use to treat~     high blood pressure (hypertension) on blood vessel remodeling. Some drugs that doctors~     prescribe for their patients contain a sulfhydryl group (a sulfur atom bonded to a hydrogen~     atom). Drugs that have the sulfhydryl group may reduce blood vessel remodeling more that~     drugs that do not. For this study, participants who have high blood pressure perform the~     experiments, take a drug for 16-weeks to lower blood pressure, and repeat the experiments.~     The researchers randomly assign one of three drugs to participants who have high blood~     pressure: a diuretic (water pill), a drug containing a sulfhydryl (SH) group, or a drug~     that does not contain a sulfhydryl group. Participants who do not have high blood pressure~     perform the experiments, but do not take any of the drugs. In some of our experiments, the~     researchers use a technique called microdialysis (MD). With MD, the researchers perfuse~     some research drugs into the skin on the forearm through tiny tubing that mimics capillaries.~     These MD drugs mimic or block substances the body naturally makes to control the small blood~     vessels in the skin. The drugs remain in nickel-sized areas around the tubing and do not go~     into the rest of the body. The researchers also analyze very small skin samples (skin biopsy)~     obtained from the forearm. Lastly, the researchers use a standard technique called flow~     mediated dilation (FMD) that uses blood pressure cuffs and ultrasound to look at the health~     of larger blood vessels in the body. FMD includes placing a small tablet of nitroglycerin~     under the tongue during part of the test.~   "
29631|NCT03179150|"~     To compare the diagnostic performance and time efficiency of Computer-Aided Detection (CAD)~     assisted reading for the identification of pulmonary nodules in chest Computed Tomography~     (CT) from oncological patients with that of unassisted reading.~   "
29632|NCT03179137|"~     Cardiac ischemia is a common pathological condition, known to elicit multiple pathological~     processes at the cellular level. One of the most affected is thought to be cellular~     metabolism, key for the adequate cardiac function. The aim is to study mitochondrial~     bioenergetic function, interaction with other cellular systems and influence of several~     co-morbidities in myocardium of the affected patients.~   "
29633|NCT03179124|"~     Children with cerebral palsy (CP) have postural control problems due to the lack of motor and~     sensory development. Trunk control which has an important role in ensuring postural control,~     is the basis for sitting, mobility, development of the upper extremity, pulmonary function~     and activities of daily living. Poor postural control restricts upper extremity functions~     which also affects the quality of movements. For this reason, it is important to assess the~     relationship between trunk control and upper extremity functions. This study is planned to~     investigate the effect of balance and trunk control on upper extremity functions in children~     with CP.~   "
29634|NCT03179111|"~     This is a prospective study whereby it involves patients who are planned for bariatric~     surgery. In the bariatric surgery procedure, pneumoperitoneum pressure will be the~     experimental aspect in this study. The pneumoperitoneum pressure will be adjusted to either~     8-10 mmHg of low pressure or to 12-15mmHg of standard pressure.~   "
29635|NCT03179098|"~     The elbow contracture is a secondary injury that can occur after direct trauma, causing the~     patient to have limitations in their range of motion. Objective evaluation protocols that~     help in decision making for the indication of these therapeutic resources have great value in~     rehabilitation, as they reduce unnecessary expenses and improve the assertiveness in the~     indication of this resource.~      Objective: To verify the immediate effects of superficial heat associated with sustained~     stretching through muscle activity and range of motion in the posttraumatic contractures of~     the elbow seeking the best indication of orthosis.~      Methods: Characterized as a randomized crossover type clinical trial. Sample of 20 adult~     subjects, of both sexes, over 18 years old, with elbow stiffness due to fractures and / or~     dislocations with indication of orthosis use. Patients will be divided into 2 randomly~     assigned intervention groups: the control group (CG) who will perform the 10 'sustained~     stretching drawn by a defined load through maximal voluntary isometric contraction (MVIC) and~     the modified Weeks Group (GWM) will perform 20 'of surface heat through the swirl and soon~     after the stretching sustained by 10' with already defined load. All patients will undergo an~     initial assessment and will participate in all 2 interventions while respecting a 7 day~     washout period. Goniometry and the visual analogue scale will be applied at the beginning and~     end of the interventions. The Delsys® brand equipment will be used to collect the~     electromyographic data. Placement and positioning of the electrodes will follow the~     determinations of the Seniam protocol. The activation of the brachial, brachioradial and~     triceps brachii muscles during the MVIC will be analyzed and also during the respective~     intervention protocols.~   "
29636|NCT03179085|"~     People reach End Stage Renal Disease (ESRD) due to progressive chronic kidney disease (CKD).~     CKD is associated with increased risk for heart disease and death. The burden of chronic~     kidney disease is increased among minority populations compared to Caucasians. New Mexico~     American Indians are experiencing an epidemic of chronic kidney disease due primarily to the~     high rates of obesity and diabetes. The present study entitled Home-Based Kidney Care is~     designed to delay / reduce rates of ESRD by early interventions in CKD. Investigators propose~     to assess the safety and efficacy of conducting a full-scale study to determine if home based~     care delivered by a collaborative team composed of community health workers, the Albuquerque~     Area Indian Health Board and University of New Mexico faculty will decrease the risk for the~     development and the progression of CKD.~   "
39400|NCT03050970|"~     The purpose of this study is to validate a clinical decision rule for the management of minor~     head trauma in infants aged less than two years, constructed with the intention of minimizing~     the rate of computed tomography scans ordering.~   "
29637|NCT03179072|"~     Managing fluid status is a complex but fundamental part of the clinical care of people~     receiving haemodialysis (HD). Day-to-day fluid management is usually based on the concept of~     'target weight' - the weight used to determine how much fluid should be removed during each~     dialysis session. However, the focus of this approach is usually on avoiding fluid overload~     (hypervolaemia), since this is associated with a higher incidence of cardiovascular and~     pulmonary events, in addition to increased morbidity and morbidity. As a consequence, a~     significant proportion of people on maintenance HD spend a great deal of time in a dehydrated~     state. Although dehydration is known to be associated with a number of unwanted consequences~     (e.g. headaches, severe fatigue, impaired cognitive and physiological function), there has~     been little research focusing on the impact dehydration has on the physical and psychosocial~     well-being of this patient group. Considering the short life expectancy of individuals with~     end-stage renal disease (ESRD) reliant on maintenance HD, particularly those who are unable~     to receive a renal transplant, we should be focused on improving their function and quality~     of life (QoL).~      Key issues that need addressing prior to developing interventions in this cohort are 1)~     investigating the best and alternative measures to assess hydration status and 2) documenting~     the biopsychosocial impact of typical target weight driven HD in a well-designed study.~   "
29638|NCT03179059|"~     Given the high rate of delayed adoption of antenatal care (ANC), and high rates of unintended~     pregnancy and unsafe abortion in Uganda, research on the period of time before confirmation~     of pregnancy is critical to understand underlying beliefs that guide behaviors ultimately~     important for maternal and neonatal health (UDHS, 2011; Hussain, 2013).~      Home pregnancy tests - which now cost less than 10 cents each - have the potential to~     facilitate FP uptake and significantly improve reproductive, maternal and child health~     outcomes in sub-Saharan Africa, including Uganda. These tests are easy to administer,~     disposable, inexpensive, and have a low false positive rate. Yet, for women living in rural~     areas in sub-Saharan countries, these tests are typically unavailable outside of health~     centers or they are prohibitively expensive.~      This study will investigate women's underlying beliefs about pregnancy status and examine how~     providing access to home-based pregnancy tests - thus facilitating earlier resolution of~     uncertainty of pregnancy status - influences such beliefs and decisions to take up family~     planning (FP) or seek appropriate pregnancy services.~      The results will inform the design of a larger study in the future.~   "
29639|NCT03179046|"~     This study is designed to investigate the association of the clinical and laboratory~     parameters or data with the cardiac structural and functional abnormalities in systemic lupus~     erythematosus(SLE). Patients with at least four ACR classification criteria for SLE and~     stable clinical condition (no need for immunosuppressive therapy intensification, i.e.~     current immunosuppressive drug dose increase or introduction of an additional~     immunosuppressive drug within last 3 months) will be included in the study. Study procedures~     will include clinical evaluation, lab tests including blood counts, liver and kidney~     functions and antibodies levels such as ANA, antiphospholipid antibodies, anti-ds DNA as well~     as inflammatory markers such as sedimentation rates. Also evaluation of cardiac status by~     cardiologist examination echocardiography and gadolinium enhanced cardiac MRI. Next,~     correlation between cardiac abnormalities and laboratory changes will be statistically~     analyzed.~   "
29640|NCT03179033|"~     Left Ventricular Assist Device (LVAD) implantation is a common surgical procedure in patients~     with end-stage heart failure. Optimal fluid management is essential for adequate~     postoperative treatment. It is important to identify which patients will benefit from fluid~     administration. Passive leg raising (PLR) is a validated dynamic method to predict fluid~     responsiveness in patients with heart failure by inducing a transient increase in cardiac~     preload. Objective: To investigate the role of PLR on the management of patients following~     LVAD implantation in the postoperative period.~   "
29641|NCT03179020|"~     This study consists in an cluster-randomized clinical trial involving near 60 Brazilian~     intensive care units (ICUs) with a high notification rate of potential donors of organs and~     tissues. ICUs will be randomized in a 1:1 ratio to manage potential organ donors through the~     use of a evidence-based checklist or to manage potential organ donors according usual care.~     The primary outcome is the rate of losses of potential donors due to cardiac arrest.~     Secondary outcome measures include number of effective organ donors, number of organs~     recovery per effective donor and total number of cardiac arrest among all potential donors.~   "
29642|NCT03179007|"~     This is a single-arm, open-label, one center clinical study, to determine the safety and~     efficacy of infusion of autologous T cells engineered to express immune checkpoint antibodies~     (CTLA-4 and PD-1) and chimeric antigen receptor targeting MUC1 in adult patients with MUC1~     positive, advanced recurrent or refractory malignant solid tumors.~   "
29643|NCT03178994|"~     To study efficacy (total numbers of acne reduction) and safety of 2% Ketoconazole cream in~     Thai females with Mild degree Post-Adolescence acne comparing with placebo for a period of 12~     weeks.~   "
29644|NCT03178981|"~     This study will compare nicotine delivery and product satisfaction in healthy subjects either~     using several different types of electronic cigarettes or smoking a conventional cigarette.~   "
29645|NCT03178968|"~     The clinical study was a single-blind, randomised intervention study to measure surface~     changes of polished and unpolished enamel in situ following an orange juice acid challenge.~     Ethical approval for the study was granted by the Stanmore Health Research Authority REC ref~     15/LO/0417, and the study was conducted per the guidelines for Good Clinical Practice. The~     study investigated a total 6 erosion regimes divided in 3 different erosion times plus ex~     vivo immersion in orange juice drink versus in vivo rinsing of the same orange juice drink.~   "
29646|NCT03178955|"~     Primary objective: To determine the changes in circadian activity rhythms and disease~     activity in rheumatoid arthritis (RA) patients from pre-treatment to one month after Enbrel~     initiation.~      Secondary objectives:~        -  To determine if there is an association between changes in circadian rhythm and changes~          in disease activity in active RA after initiation of Enbrel~        -  To determine if the changes in circadian activity rhythms are associated with systemic~          inflammation in RA patients~        -  To determine changes in traditional sleep quality variables from pre-treatment to one~          month after Enbrel initiation in RA patients~   "
29647|NCT03178942|"~     Study to Evaluate the Therapeutic Equivalence of Permethrin Cream 5%in the Treatment of~     Scabies.~   "
29650|NCT03178903|"~     The purpose of this study is to examine the efficacy of tDCS (transcranial direct current~     stimulation) for increasing exercise adherence among low active individuals with elevated~     depressive symptoms. The investigators expect that this project will contribute much needed~     knowledge about the role that tDCS can play in changing the affective experience of exercise.~   "
29651|NCT03178890|"~     Advanced prosthetic devices are currently controlled by electromyography (EMG) signals~     generated by patient's stump muscles and recorded by surface electrodes attached on the skin.~     This way of recordings is often unreliable, inconsistent and leading to high prosthetic~     abandonment rates for individuals with upper limb amputation. The use of implantable~     electrodes has been long thought as the solution for a more natural control of artificial~     limbs, as these offer access to long-term stable and physiologically appropriate sources of~     control, as well as the possibility to elicit appropriate sensory feedback via~     neurostimulation.~      This Clinical Investigation (CI) is performed to clinically test and verify the safety and~     benefits of a bidirectional interface into the human body that allows permanent and reliable~     communication using implanted electrodes. These electrodes will provide long-term stable~     bioelectric signals for an improved control of artificial limbs. The bidirectional interface~     is based, and requires, the clinically established implant system for bone-anchored~     prostheses named Osseointegrated Prostheses for the Rehabilitation of Amputees (OPRA). The~     feasibility of the device was initially proven through a proof-on-concept patient who has~     used the system without any adverse events for more than three years.~      This CI is performed to verify the safety and benefits of the Osseointegrated Human Machine~     Gateway (OHMG) as an enhancement of the OPRA Implant System for patients with upper limb~     amputation, when used within the intended purpose and according to instructions. The CI will~     be performed at Sahlgrenska University Hospital and Chalmers University of Technology,~     Sweden. A maximum of eighteen patients will be enrolled. Each patient will undergo a surgery~     where the OHMG will be implanted. The patients will participate in 8 follow-up sessions, the~     last one approximately 13 months after the surgery. The study is prospective, where the~     patient is his/her own control.~   "
29652|NCT03178877|"~     A cross-sectional study of 350 medical student Universitas Indonesia from first grade until~     fifth grade was done during November-December 2016. This study used stratified randomized~     sampling. The Rome IV criteria was used for diagnosing IBS. Questionnaire-guided interview~     was applied to all subjects.~   "
29653|NCT03178864|"~     SECRET examines the safety of rivaroxaban versus standard-of-care for treatment of~     symptomatic cerebral venous thrombosis, initiated within 14 days of diagnosis.~   "
29654|NCT03178851|"~     This study will evaluate the preliminary efficacy, safety, and pharmacokinetics of~     cobimetinib and atezolizumab in participants with advanced BRAF V600-wild type (WT),~     metastatic, or unresectable locally advanced melanoma who have progressed on prior anti−PD-1~     therapy. In addition, this study will evaluate the efficacy, safety, and pharmacokinetics of~     atezolizumab monotherapy in participants with BRAFV600-WT metastatic or unresectable locally~     advanced melanoma, who have not been previously treated.~   "
29655|NCT03178838|"~     The buccal cavity presents microorganismes whose the number and composition vary with oral~     hygiene and medical context (pathologies and associated drug therapies) of the patient. More~     than 1200 bacterial species have been identified, and among them, 400 are inhabitants of the~     sub-gingival biofilm. Among all these microorganismes, only 20 species participate to the~     etiopathogenesis of periodontal diseases.Some are recognised as major periodontopathogens~     other play unclear role in this pathology. They belong respectively to the red and orange~     complex of Socransky et al. (1998).~      Other microorganismes such as virures, yeasts and protozoans could potentially impact the~     emergence and development of periodontal diseases. The presence of protozoans in~     periodontitis have been investigated in this study.~   "
29656|NCT03178825|"~     This multi-center clinical trial will evaluate the safety and long-term efficacy of hybrid~     fractional 2940 nm and 1470 nm lasers for treatment of symptoms of Genitourinary Syndrome of~     Menopause.~   "
29657|NCT03178812|"~     This study aims to find a correlation between cytokines levels and malignancy potential of~     different cystic types.~   "
29658|NCT03178799|"~     Aims: To compare clinical outcomes for patients under FLS or usual care at the NTUH MH and~     BB.~      Method: Four hundred subjects with new hip fracture or newly identified vertebral fracture~     are randomly assigned into FLS and usual care (UC). FLS subjects received~     osteoporosis-related assessments, treatments, consultations on diet, medications, exercise,~     fall preventions given mainly by care managers with followed up telephone call at 4, 8, 12,~     18, 24 months then annually for up to 10 years. Physicians manage UC subjects at their own~     plans without pre-specified protocols as FLS subjects. Care managers will perform baseline~     assessments and follow them by telephone annually for up to 10 years. Major outcomes include~     bone mineral density assessment rate, calcium, vitamin D, and osteoporosis medication~     initiation and adherence rate, fall and fracture incidences, mortality, and healthcare~     resource utilizations.~   "
29659|NCT03178786|"~     The purpose of this dual phase cross-sectional, controlled and prospective, open label,~     exploratory study is to determine the general characteristics of visuospatial exploration and~     its neural substrate in subjects with Parkinson's Disease (PD) and to explore the impact of~     professional art therapy intervention in a cohort of subjects with Parkinson's Disease on~     visuospatial exploration, visuomotor integration, neuropsychological and emotional sphere,~     quality of daily living and motor symptoms.~   "
29660|NCT03178773|"~     This is an intervention to study incorporating social support into mHealth interventions for~     low-income, ED patients with diabetes~   "
29661|NCT03178760|"~     The purpose of this study is to measurement of optic nerve sheath diameter in children~     without intracranial pressure increase and determine the average optic nerve sheath diameters~     for healthy children.~   "
29662|NCT03178747|"~     To compare the sensitivity of Tzanck smear with methylene blue stain versus traditional~     Giemsa stain in patients with herpes infection.~   "
29663|NCT03178734|"~     The purpose of this study is to compare UTI rates and patient satisfaction associated with~     indwelling Foley catheter verses a valved catheter in patients who are being discharged home~     with a catheter after urogynecologic procedures via a Randomized Clinical Trial.~   "
29664|NCT03178721|"~     Systemic lupus erythematosus , the archetypal multisystem autoimmune disease, presents many~     diagnostic and management challenges. One such challenge is the excess cardiovascular disease~     observed in patients with Systemic lupus erythematosus . Coronary heart disease and other~     manifestations of atherosclerosis continue to be a major cause of death in patients with~     Systemic lupus erythematosus.Regulatory B-cells have been identified as a negative regulator~     of the immune system that inhibit pathological immune response by suppressing both~     uncontrolled protective immune response and damaging autoimmune responses~   "
29665|NCT03178708|"~     During the surgical procedure of scoliosis correction, large surgery extent and long-lasting~     strong nociceptive stimulation lead to postoperative pain formation of greater intensity~     compared with other orthopedic interventions. In these patients, duration of postoperative~     symptoms is longer, and may lead to persistent pain formation due to developing neuroplastic~     changes in the central nervous system.~   "
29666|NCT03178695|"~     The Inovium Ovarian Rejuvenation Treatment is a PRP-based autologous treatment used in~     combination with a stimulated IVF sequence and Pre-Implantation Genetic Screening to treat~     infertility in women experiencing menopause, perimenopause, and premature ovarian failure.~   "
29667|NCT03178682|"~     evaluation of the role of ultrasonographic parameters (mean gestational sac diameter, yolk~     sac diameter, crown rump length, embryonic heart rate and uterine artery Doppler) in~     predicting early pregnancy failure in patients with recurrent pregnancy loss~   "
29668|NCT03178669|"~     The purpose of this study is to evaluate efficacy of cobitolimod treatment at different dose~     levels and frequencies compared to placebo in patients with moderate to severe active~     ulcerative colitis.~   "
29669|NCT03178656|"~     According to the guidelines recommended, only a few new targeted therapy drugs treatment,~     such as Sorafenib, is proper. It's 3 year survival rate is only 8% or so. According to our~     previous study, patients with hepatic carcinoma without portal vein tumor thrombus backbone~     and the contralateral tumor thrombus applyed tumor excision, along with tumor thrombus, the 3~     year survival rate can reach 39.9%, the 5-year survival rate can reach 22.7%, curative effect~     is obviously better.~   "
29670|NCT03178643|"~     This is a randomized, three-arm, open-label, clinical trial of malaria chemoprevention in~     children with sickle-cell anemia (SCA) at a single site in Homa Bay, Kenya. The study will~     enroll 246 children under 10 years of age, randomize participants 1:1:1 to one of three~     malaria chemoprevention regimens, and follow participants monthly for 12 months in order to~     record clinical episodes of malaria or SCA-related morbidity. Analyses will compare the~     efficacy of each regimen to prevent malaria and SCA morbidity.~   "
29671|NCT03178630|"~     Autoimmune liver diseases (AILD), which include Primary Sclerosing Cholangitis (PSC) and~     Autoimmune Hepatitis (AIH) are a common etiological factor for chronic liver disease among~     adolescents. This is a longitudinal study to identify surrogate endpoints with an accurate~     predictive value for the progression of hepatobiliary damage in subjects with pediatric onset~     AILD. This study will involve collection of MRI-based data at the time of enrollment and at~     year 1 and 2 of follow up, and collection of clinical data for 10 years following enrollment.~     There is a strong possibility that MRI quantitative techniques may be more sensitive to~     disease progression than standard clinical and laboratory tests. To investigate predictivity~     of MRI based biomarkers, summary measures of MRCP/MREL from baseline, Year 1 and Year 2, e.g.~     change rate, maximum, and average will be calculated as predictors for Year 10 clinical~     outcomes. The same predictors will also be used to model native liver survival in a~     proportional hazard regression. Findings from this study may be used to assess disease~     progression and to predict complications and survival of liver disease patients.~   "
29672|NCT03178617|"~     This randomized clinical trial studies how well a high-intensity intervention parenting~     program works in improving learning and school functioning in Latino children with acute~     lymphoblastic leukemia, acute myeloid leukemia, or lymphoblastic lymphoma. A high-intensity~     intervention program may help doctors to see whether training parents or caregivers in~     specific parenting skills and pro-learning behaviors will result in better learning and~     school outcomes for Latino children with acute lymphoblastic leukemia, acute myeloid~     leukemia, or lymphoblastic lymphoma. It is not yet known if a high-intensity intervention~     program is more beneficial than a standard of care lower intensity parenting intervention.~   "
29673|NCT03178604|"~     In this study we intend to apply a treatment protocol for hamstrings that can be beneficial~     for a good recovery.~      Initially, a sample of athletes with hamstring shortening was chosen. Once the sample is~     chosen, it will be divided into three groups: group 1 (G.1) who will receive a massage~     protocol, group 2 (G.2) that receives the muscular chain approach, and last group 3 (G.3)~     soft massage.~      To finalize the study comparing the results of the three groups to observe the experimental~     protocol obtains better results.~      Material and methods The sample of an athletic club. Recruiting subjects between 18 and 45~     years old without other injuries of the lower limb. Subjects with shortening of the hamstring~     muscles are available through the specific shortening test.~      This is a randomized controlled trial. Subjects were randomly assigned to three intervention~     groups (2 treatment and 1 placebo control). The intervention consists of 4 sessions for 1~     month. The sessions have a duration of 45 minutes. Evaluations are performed at the beginning~     of treatment, at the end of treatment and one follow-up per month. Participants also perform~     strengthening exercises three days a week, a total of 3 sets with 15 repetitions each.~      Group 1 receives a moderate intensity massage based on petrissage treatment of the quadriceps~     and hamstrings.~      Group 2 receives a moderate-high intensity massage based on friction of the quadriceps and~     hamstrings.~      Group 3 received low intensity massage treatment. Receives a soft massage treatment of the~     quadriceps and hamstrings.~      In addition, all groups work on strengthening the muscles of the lower limbs with eccentric~     work 3 times a week.~      The assessments consist of knee and hip goniometry, lumbar and hamstring flexibility by~     finger-to-floor testing, pain measurement on the visual analogue scale (EVA), and complete~     the questionnaire Mood Status Profile (POMS) , Which evaluates the states of mind~   "
29674|NCT03178591|"~     Type 2 diabetes mellitus (type 2 DM) is an important disease with increasing prevalence~     worldwide. More than 60% of diabetes patients die of CVD. Diabetes is associated with 2-to 4-~     fold increase in the risk of coronary artery disease (CAD). Diabetes patients with stable~     ischemic heart disease may have more prevalent of asymptomatic ischemia or silent ischemia~     due to autonomic neuropathy. Therefore, detection of total myocardial ischemia including both~     symptomatic and silent ischemia using ambulatory electrocardiogram monitoring may provide~     better accuracy in ischemic burden and prognosis in diabetes patients. DDP-4 inhibitors have~     favorable effects on atherosclerotic risk factors beyond glycemic control. Furthermore, DPP-4~     inhibitors may have favorable effects on ischemic preconditioning in patients with CAD. For~     this study we aim to compare the effects of between vildagliptin and Dapagliflozin on~     ischemic burden defined by total ischemic time, markers of autonomic function, biomarkers of~     myocardial injury and biomarkers of inflammation.~   "
29675|NCT03178578|"~     This prospective observational study aims to (i) asses intensive care doctors trigger for and~     the expected physiological response to a fluid bolus and (ii) evaluate the patient's actual~     physiological response to a single fluid bolus at one hour post-bolus for 100 adult patients~     admitted to the intensive care unit will be included in the study.~   "
29719|NCT03178006|"~     This project aims to establish the correlation between intestinal microbiota with~     inflammatory biomarkers, intestinal morphology, vascular reactivity and degree of hepatic~     fibrosis in patients with different degrees of glucose tolerance and body adiposity.~   "
29676|NCT03178565|"~     The present study aims to evaluate the effect of mechanical insufflation-exsufflation on~     airway mucus clearance among mechanically ventilated ICU patients. A parallel group~     randomized clinical trial will be conducted in a single mixed medical-surgical ICU of a~     tertiary hospital in Southern Brazil. Adult ICU patients with a length of mechanical~     ventilation >24 hours will be evaluated for eligibility. Patients will be randomized in a 1:1~     ratio to receive respiratory physiotherapy using a mechanical insufflation-exsufflation~     device (intervention group) or standard respiratory physiotherapy without the use of the~     mechanical insufflation-exsufflation device (control group). The primary outcome is the~     amount of aspirated respiratory mucus (weight in grams) 5 minutes after the finish of~     respiratory physiotherapy.~   "
29677|NCT03178552|"~     This is a phase 2/3, global, multicenter, open-label, multi-cohort study designed to evaluate~     the safety and efficacy of targeted therapies or immunotherapy as single agents or in~     combination in participants with unresectable, advanced or metastatic NSCLC determined to~     harbor oncogenic somatic mutations or positive by tumor mutational burden (TMB) assay as~     identified by two blood-based next-generation sequencing (NGS) circulating tumor DNA (ctDNA)~     assays.~   "
29678|NCT03178539|"~     Compare between the analgesic efficacy of diclofenac sodium and ketorolac tromethamine in~     post-tonsillectomy pain management.and Compare between the effect of diclofenac sodium and~     ketorolac tromethamine on post-tonsillectomy bleeding~   "
29679|NCT03178526|"~     Aim: this double-blind split-mouth clinical trial study was performed to evaluate the~     clinical and radiographic effect of local delivery of lovastatin gel as an adjunct to scaling~     and root planning (SRP) in the treatment of chronic periodontitis.~      Method and Materials: 15 patients with two mandibular molar teeth with probing depth (PD)≥3~     mm, clinical attachment level (CAL)≥3 mm and bone loss more than 3 mm according to parallel~     periapical x-ray and distance from CEJ to alveolar crest, were selected.Totally 24 mandibular~     molars were selected for the study.~      Clinical periodontal parameters included PD, CAL, bleeding index(BI), plaque index(PI) were~     recorded for the selected teeth at baseline and at 1,3 and 6 months. Radiographic assessments~     were performed at baseline and after 6 months. At one side the pockets around randomly~     selected molar were injected with a blunt syringe filled with lovastatin gel 1.2%( case~     group=B), and on the other side, the pockets were filled with a placebo gel by a blunt~     syringe ( control group=A).Two-way repeated measure ANOVA test and T-test were used for~     statistic analysis Spss 23.( P<0.05) was considered significant.~   "
29680|NCT03178513|"~     New or worsening symptoms following discharge from the hospital likely leads to unplanned~     readmission. These rates are higher than desired and costly to patients, payers, and~     providers. Many interventions have unsuccessfully attempted to reduce readmissions, but few~     have provided in-home personnel to patients transitioning from acute care back to ambulatory~     care. Still fewer have involved a physician in the home. We therefore will test the effect of~     a physician home visit to a patient's home who was discharged in the last 4 days.~   "
29681|NCT03178500|"~     A RCT will be conducted to compare the traditional clomiphene citrate regimens for ovulation~     induction with the stair-step protocol. Sixty women will be included after obtaining their~     written informed consent and will be randomized into either of the 2 groups.~   "
29682|NCT03178487|"~     This is a Phase 2/3 multicenter, randomized, double-blind, placebo-controlled study to~     evaluate the safety and efficacy of upadacitinib in participants with active ankylosing~     spondylitis (AS).~   "
29683|NCT03178474|"~     Objective：The present trial aimed to assess efficacy and safety of Jin Ling Guan and Tofer~     infant formula on body growth, intestinal tolerance, gut microbiota and fecal residual~     nutrients as compared to breast-milk in term Chinese infants.~      Participants：189 healthy termed-infants with ages of 5-14 days at the enrollment.~      Study Design: A multiple-center, quasi-randomized,open labeled, controlled trial. Random~     allocation between the two infant formula.~      Arms, Groups, and Intervention: (1) Breast milk-fed group: fed with human breast milk; (2)~     JINLINGGUAN Formula Group：fed with JINLINGGUAN infant formula (PRO-KIDO™ I-PROTECH®, Phase~     I); (3) TOFER Formula Group: feeding TOFER infant formula (TOFER®, Phase I). Random~     allocation performed between the two formula groups.~      Intervention Duration: 12 weeks.~      Visits: 1 week(baseline), 7 and 13 weeks of age~      Outcome measures: (1) General information, general health and wellbeing, regular body~     check;(2) Anthropometric parameters: body length, body weight, and head circumferences; (3)~     Stool characteristics (color , volume, stool consistency, and frequency;(4)Behavior and~     habits; (5) Gut microbiota; (6) Residual nutrients in feces (nitrogen,total fat, fatty acids,~     minerals); (7) adverse events and concomitant medications; (8) compliance. Slopes of changes~     from baseline to 6 and 12 weeks post intervention in anthropometric parameters, stool~     characteristic index, fecal residual nutrients, pattern score of gut microbiota, behavior and~     habit index were be calculated.~   "
29684|NCT03178461|"~     To evaluate the influence of warm IV fluids during delivery and cesarean section on perinatal~     outcomes.~   "
29685|NCT03178448|"~     The objective of this study is to characterize the prevalence of clinical or subclinical~     polyvascular lesions and 4-year progression rate of plaque in intracranial and carotidal~     arteries in a Chinese community population using vascular imaging techniques; to investigate~     the both traditional and emerging genetic, metabolomic, and environmental risk factors of~     presence and progression of intracranial and carotidal plaque; and to investigate the~     association between polyvascular lesions and future risk of cognitive impairment,~     cardio-/cerebrovascular events and death.~   "
29686|NCT03178435|"~     An interventional controlled trial to test the feasibility of applying risk score based~     prevention for critically ill patient at high risk to develop acute kidney injury (AKI)~   "
29742|NCT03177707|"~     With improvements in detection and treatment of prostate cancer (PCa), more men than ever are~     living with side effects from PCa treatment; most distressingly, treatment side effects~     include problems with sexual functioning (e.g. erectile dysfunction, climacturia,~     inorgasmia). This study aims to develop a mindfulness-based group treatment for couples with~     sexual functioning complaints post-PCa treatment. Couples will be invited to a four-session~     mindfulness-based treatment group. Pre- and post-treatment outcomes (e.g., distress, sexual~     functioning/enjoyment, relationship satisfaction, treatment adherence) will assess~     feasibility and effectiveness of this novel treatment for couple's sexual lives after PCa.~   "
29687|NCT03178422|"~     Transdermal nicotine delivery systems are a cigarette smoking cessation aid designed to~     deliver nicotine into the systemic circulation via the skin. They have been found to reduce~     craving, thereby enhancing a patient's success for quitting smoking. However, side effects~     such as sleep disturbances and skin irritation, as well as incomplete smoking cessation are~     commonly experienced by users of such systems. Chrono Therapeutics, Inc. has developed an~     innovative programmable transdermal drug delivery system called the Chrono Quit Smoking~     Solution (CQSS2) that provides off periods (periods in which little to no nicotine is~     delivered), which is an advantage over existing systems that currently provide continuous~     delivery. The most important features of the CQSS2 are the periodic automatic dosing, plus~     the reduced side effects of sleep disturbances and potentially, skin irritation. The period~     when less nicotine is being delivered through the skin allows the skin an opportunity to~     recover, thereby potentially reducing skin irritation. Another major benefit is the~     automatic dosing, which provides higher drug dosage at specific times of the day, leading to~     potentially greater success in quitting smoking. In this study, the CQSS2 will be used in~     conjunction with the Digital Coach application (app). The Digital Coach is a custom mobile~     app that provides behavioral support for the CQSS2. Together, the CQSS2 and the Digital Coach~     comprise the CQSS2 System.~   "
29688|NCT03178409|"~     Combined hepatocellular and mass-forming cholangiocarcinoma (cHCC-MFCCC) is a rare tumor. The~     aim of this study was the analysis of the outcome comparing such tumor with classic~     hepatocellular carcinoma (HCC) and mass-forming cholangiocarcinoma (MFCCC).~   "
29689|NCT03178396|"~     The investigators will be studying the effect of melatonin on blood pressure, insulin~     resistance, and platelets, along with possible reasons for how melatonin cases these effects.~   "
29690|NCT03178383|"~     This population-based application responds to the American Cancer Society Research Scholar~     Grant, Priority Program in Cancer Control. Recent years have seen a growing research interest~     in learning how to get known-effective health education strategies to reach more people who~     could benefit from them. An important part of this growing movement is a focus on sustained~     impact, or continued program benefit after the funding period is over. It is believed that~     the best way to achieive this sustained impact is through integrating the program into the~     host community at multiple levels. This innovative strategy has not been systematically~     tested in community-based settings, where the most vulnerable people can be reached. Since~     churches have a historical and ever-growing role in health promotion particularly among~     African Americans, they are an ideal place to reach this group for cancer education. The~     proposed project will compare two ways to apply a known-effective cancer educational strategy~     through African American churches: 1) a standard method vs. 2) a new method in which the~     churches integrate the strategy into their organizational structure and practice at multiple~     levels. It will be determined whether this integrated approach results in more effective~     and sustained cancer education and screening activities at both the church and individual~     levels over time. The educational strategy is one that has been used successfully in previous~     work: Project HEAL (Health through Early Awareness and Learning). Project HEAL is a series of~     three cancer early detection workshops (breast, prostate, colorectal) delivered through~     trained and certified lay peer community health advisors in African American churches. 14~     churches will be randomly chosen to conduct either the standard Project HEAL program or an~     integrated Project HEAL strategy where the churches build the program into their organization~     in multiple ways (e.g., allocating volunteer or paid staff, space, or funds; policy change;~     ministry development). The project will be conducted in three phases: 1) refining the~     integrated approach with community and stakeholder feedback; 2) pilot testing the integrated~     approach in 2 churches; and 3) conducting the study to comparatively evaluate the standard~     vs. the integrated approaches in 14 churches. A scientifically rigorous evaluation plan will~     be used to look at outcomes at both the individual and the church level. This project will~     make important contributions to research in evidence-based medicine and sustainability. In a~     climate of limited resources, identifying sustainable and effective ways to increase cancer~     awareness and screening in African American men and women is more important than ever.~   "
29691|NCT03178370|"~     Autonomic, inflammatory, enteric, electrophysiologic and hormonal.~   "
29692|NCT03178357|"~     Hypertrophic cardiomyopathy (HCM) is the most common hereditary disease characterized by left~     ventricular hypertrophy and consequently left ventricular diastolic dysfunction. Its~     prevalence is estimated at around 0.2% in the general population. HCM is the most common~     cause of sudden cardiac death due to cardiovascular disease in young athletes, accounting for~     one third of deaths. HCM patients often have symptoms of heart failure. The ESC~     recommendations for heart failure (HF) from 2016 recommend exercise training regardless of~     ejection fraction to improve exercise capacity, quality of life, and reduction in~     hospitalizations due to HF. Meanwhile, for many years, HCM was equivalent to exercise~     training limitation. According to the 2014 ESC guidelines, it is recommended for patients~     with HCM to avoid sports practice. However the results of Edelmann et al. research, suggest~     that physical training leads to a significant clinical improvement in patients with diastolic~     dysfunction and thus may be beneficial in patients with HCM. In 2015 results of a first study~     were published (Klempfner et al.), which showed that the majority of HCM patients with~     moderate risk undergoing supervised physical training had improved physical performance and~     no significant adverse events were recorded. The study was limited by the small number of~     admitted patients (twenty), lack of control group and failure to perform cardio-pulmonary~     exercise test.~      The main goal of the study will be to evaluate the effectiveness and safety of comprehensive~     cardiological rehabilitation and telerehabilitation in patients with hypertrophic~     cardiomyopathy without left ventricular outflow tract obstruction with preserved systolic~     function. The study is planned to include 30 patients with HCM subjected to physical training~     and 30 patients with HCM in the control group treated as standard according to current~     guidelines, not subjected to physical training.~   "
29693|NCT03178344|"~     Transcranial Alternating Current Stimulation (tACS) is one method that has been demonstrated~     to enhance alpha oscillations in healthy participants by applying weak electrical currents to~     the scalp to modulate rhythmic brain activity patterns. This study will involve tACS-induced~     frontal alpha oscillations, EEG recordings, and other physiological and biological measures.~   "
29694|NCT03178331|"~     The aims of the study are 1) to evaluate the potential benefits or harm of school doctors'~     routine health checks and 2) to explore whether part of the school doctors' routine health~     checks can be omitted using study questionnaires which address the parents', school nurses'~     and teachers' concerns regarding each child.~   "
29695|NCT03178318|"~     Ability to provide oxygen to patients undergoing general anaesthesia is crucial. This is~     traditionally provided using face mask, supraglottic airway (breathing tube above voice box)~     or endotracheal tube (breathing tube in wind pipe). However in some patients it may be~     impossible to provide oxygen through any of these above means which can be life threatening~     and lead to permanent brain damage/death. One of the ideal ways of managing this emergency~     situation is to pass a breathing tube through a membrane in the front of the neck called~     cricothyroid membrane with the neck in extension position where permitted. Many studies have~     recommended identifying the cricothyroid membrane before general anaesthesia in high risk~     patients but with their head in neutral position. This study will be a pilot study to check~     if the cricothyroid membrane remains in the same place in neutral and extended positions.~   "
29696|NCT03178305|"~     The Do CHANGE service is designed for cardiac patients who could benefit from lifestyle~     change and a better disease management. The study aims to support patients with behavior~     change by providing them with devices and behavioral intervention in order to facilitate~     long-term behavior change.~   "
29697|NCT03178292|"~     To evaluate whether 5 days of levofloxacin before percutaneous nephrolithotomy (PCNL) in~     reducing upper urinary tract infection and urosepsis after PCNL.~   "
29698|NCT03178279|"~     People suffering from psychotic illnesses (e.g. schizophrenia) have poorer physical health~     than the general population. The reasons include a lack of service user motivation to attend~     physical health checks and the tendency of health professionals to focus mainly on the mental~     disorder thus delaying the detection of physical health conditions.~      Identifying people who have physical health needs is increasingly recognised as a priority.~     The investigators have developed a Physical Health Plan (PHP) which is completed by service~     users and identifies areas of physical health need. An action plan is then completed by the~     service user and care co-ordinator to address these issues.~      The PHP is designed to be very simple to use and there will be 3 versions, 1. paper version,~     2. 1 version implemented via the 'IMPARTS' computerised 'tablet' based system that has been~     separately evaluated (REC Ref 12/SC/0422) and 3. 1 version on an iPad via the MHL2 system via~     Mindwaves.~      The investigators wish to pilot the use of this PHP in two community teams in the South~     London and Maudsley (SLaM) Trust. The pilot will be done in three stages.~      Stage One: The investigators will undertake an initial qualitative study to refine the~     process of using the PHP using focus group consultations with staff and service users.~      Stage Two: The investigators will then undertake a six month study to evaluate the uptake and~     use of the PHP. This will involve collecting data on how many people complete the PHP and~     what actions are taken following the completion of the PHP.~      Stage Three: At the end of this six month period the investigators will undertake qualitative~     interviews with a selection of service users and staff to understand their experience of~     using the PHP.~      The investigators hope to be able to use the results of this pilot study to introduce the use~     of the PHP into routine care.~   "
29699|NCT03178266|"~     This study is a prospective, randomized, single center, study to evaluate Zip Closure Device~     in subjects undergoing knee arthroplasty. Patients identified as candidates for knee~     arthroplasty and meet the study selection criteria will be approached and considered for the~     study. Knee Arthroplasty of 40 subjects will be enrolled where 20 subjects will receive~     ZipLine and 20 subjects will receive Staples.~   "
29700|NCT03178253|"~     Diabetes Mellitus is the most common disorder seen. The impact of this disease on the quality~     of life, and on morbidity and mortality through the complications that affect the small and~     large vessels resulting in retinopathy, nephropathy, neuropathy, and ischemic heart disease~     has been emphasized by the findings of the national commission (USA) on diabetes .~      So, there was curiosity to understand and learn the association of this disorder with another~     common endocrine gland function that is thyroid gland . The association between these two~     disorders has long been recognized although the prevalence of thyroid dysfunction in diabetic~     population varies widely between studies. With insulin and thyroid hormone being intimately~     involved in cellular metabolism and thus excess or deficit of these hormones result in~     functional derangement of the other.~   "
29701|NCT03178240|"~     Randomized trial looking at the effects of a behavioral photoaging software intervention on~     sunscreen use in the city of Itauna, Brazil.~   "
29702|NCT03178227|"~     Before February 2018 the baseline survey is conducted in about 60 class in Brazilian~     secondary schools. These classes are randomized to control and intervention group in a 1/1~     manner. A few weeks thereafter medical students from the local medical school visit the~     schools and perform a smoking prevention intervention called photoaging mirroring~     intervention which takes about 45 minutes. One month and six months after the intervention~     the intervention group receives another anonymous questionnaire monitoring smoking status.~     The primary endpoint is the difference in the chance of smoking prevalence between the two~     groups.~   "
29703|NCT03178214|"~     This is a single centre, open-label, randomised, single dose, three-period, crossover study~     to evaluate the bioavailability of Infacort® administered as 'sprinkles' with soft food and~     yoghurt compared with direct administration to the back of the tongue in~     dexamethasone-suppressed healthy adult male subjects.~      The study will comprise of a pre-study screen, followed by 3 treatment periods and a~     post-study follow-up.~   "
29704|NCT03178201|"~     The primary objective is to determine the overall response rate (ORR) of TGR-1202 in R/R FL.~      Secondary Objectives~        -  Determine the genetic and other novel biological markers that may be predictive of~          response or resistance to TGR-1202 in patients with relapsed or refractory FL.~        -  Describe the Progression Free Survival (PFS), Duration of Response (DoR) after treatment~          with TGR-1202.~        -  Describe the number of dose delays and dose reductions and other safety profile.~   "
29705|NCT03178188|"~     forty DLE lesions from patients will be recruited in the study. The lesions on one side of~     the body were block-randomized into the treatment group and the other side served as a~     control. The patients can continue their systemic treatments and the PDL is designed to be~     used as an adjunctive treatment. Treatments with the PDL will be delivered in the treatment~     group every 4 weeks for 4 consecutive months while the lesions in the control group received~     a sham. The patients will be evaluated at baseline (week 0), week 4, 8, 12, and at follow-up~     period of 4, 12 weeks after the final treatment (week 16, 24). Erythema index (EI), Texture~     index (TI) will be obtained and digital photographs will be taken and modified Cutaneous~     Lupus Erythematosus Disease Area and Severity Index (mCLASI) will be assessed in every visit.~     The digital photographs will later be evaluated by 3-blinded dermatologists. Moreover, side~     effects and patients' satisfaction score will also be recorded.~   "
29706|NCT03178175|"~     This plan is to evaluate the effectiveness of scalp acupuncture, a modern acupuncture~     technique specialized to neurological disorders, in managing motor function and body balance~     for PD patients. This is a randomized, controlled, single-blind clinical trial.~   "
29707|NCT03178162|"~     There are different methods for measuring cardiac output (CO) completely non-invasive, which~     are used today. Two of these should be used in the study to examine the CO in an older group~     of patients (> 65 years) undergoing major trauma surgery. The first method is the~     esCCOTM-technology by Nihon Kohden, the second uses the Volume Clamped Method via a~     finger-cuff by Nexfin Edwards life sciences. Both technologies work continuously and fully~     non-invasive.~      The measured data will be compared to established standard procedures like semi-invasive~     pulse contour analysis using the Flotrac-Vigileo system. The study should answer the~     following questions:~      How accurate and precise are the non-invasive methods? How large is the percentage deviation~     in comparison to the established standard? Are there any limitations of measuring accuracy~     regarding the age of the patient? The continuous hemodynamic monitoring of patients during~     surgery has recently changed from invasive and semi-invasive methods to completely~     non-invasive technologies. The accuracy and precision of this way of measuring cardiovascular~     parameters in comparison to the invasive standard is still controversial. Especially for~     older patient with atherosclerotic alteration of the blood vessels the utility of~     non-invasive monitoring systems is not shown yet. But principally this group with a high~     level of comorbidity might profit notably from less invasive procedures. This is the reason~     for the planed research.~   "
29708|NCT03178149|"~     The purpose of this study during the Dose Escalation stage is to assess the safety and~     tolerability of 3 ascending doses of ASP7317 in participants with age-related macular~     degeneration (AMD), of which one dose will be selected for evaluation of efficacy and safety~     during the Proof of Concept (PoC) stage of the study.~      The primary purpose of the study during the PoC stage is to assess the safety, tolerability~     and superiority of ASP7317 at low cells/dose and the selected dose compared to untreated~     control and ASP7317 low cells/dose versus the selected dose in best corrected visual acuity~     (BCVA). This study will also assess safety by incidence of graft failure or rejection with a~     13-week regimen of immunosuppression therapy.~      Efficacy will also be assessed by the differences among ASP7317 at low cells/dose, ASP7317 at~     the selected dose and the untreated control group in other functional and structural~     parameters and patient reported outcomes during the PoC stage.~      During the Extension stage this study will assess the safety and tolerability of ASP7317 at~     the most efficacious dose from PoC in participants randomized to the untreated control group.~   "
29709|NCT03178136|"~     It is universally accepted that the persistent infection of high-risk human~     papillomavirus(HR-HPV) is the cause of cervical intraepithelial neoplasias and cancer. Some~     researches indicate that the virus load may relate the extent of the disease. The objective~     of the study is to detect the virus load of 14 types HR-HPV among the participants, using a~     new HPV DNA hybrid capture technology,sequentially find the diagnostic significance of virus~     load of HPV.~   "
29710|NCT03178123|"~     This is a phase II randomized, control, multi-center study of recombinant humanized anti-PD-1~     mAb for injection compared to high-Dose interferon in patients with mucosal melanoma that has~     been removed by surgery.~   "
29711|NCT03178110|"~     The objectives of this pilot study are to determine the effectiveness of a manual therapy~     (MT) protocol plus the use of a dynamic jaw opening device on the maximal interincisor~     distance; on trismus symptoms; on pain-disability outcomes and on the quality of life,~     anxiety, and depression in subjects with trismus. The proposed pilot study will comprise a~     single subject design with multiple baseline measures and during treatment phases to~     determine the effectiveness of the treatment protocol. A minimum sample of 10 subjects will~     be recruited. The Health Research Ethics Board of Alberta Cancer Committee will approve this~     study. Participants will receive a MT protocol plus exercises and the use of the DTS device~     for 6 months. The first two weeks of treatment will involve only MT and opening~     exercises.After this initial 2 weeks, the DTS will be introduced. The participants will~     receive a session of 30-45 minutes of MT three/two times per week, for 24 weeks. All~     participants will be instructed how to use the Dynasplint® Trismus System at home.~      Analyses: Visual analyses will be performed on participant before, during, and after the~     intervention. The 2-standard deviation band method will be used to analyze the behavior of~     each participant on the outcome of interest before, during, and after the treatment. The~     minimally important difference levels in order to determine clinical relevance will be done.~     Two effect size indexes will be used: the percentage of non-overlapping data, and the~     percentage of improvement rate difference.~   "
29712|NCT03178097|"~     There are different methods for measuring cardiac output (CO) completely non-invasive, which~     are used today. Two of these should be used in the study to examine the CO in an older group~     of patients (> 65 years) undergoing major trauma surgery. The first method is the~     esCCOTM-technology by Nihon Kohden, the second uses the Volume Clamped Method via a~     finger-cuff by Nexfin Edwards life sciences. Both technologies work continuously and fully~     non-invasive.~      The measured data will be compared to established standard procedures like semi-invasive~     pulse contour analysis using the Flotrac-Vigileo system. The study should answer the~     following questions:~        -  How accurate and precise are the non-invasive methods? How large is the percentage~          deviation in comparison to the established standard?~        -  Are there any limitations of measuring accuracy regarding the age of the patient?~      The continuous hemodynamic monitoring of patients during surgery has recently changed from~     invasive and semi-invasive methods to completely non-invasive technologies. The accuracy and~     precision of this way of measuring cardiovascular parameters in comparison to the invasive~     standard is still controversial. Especially for older patient with atherosclerotic alteration~     of the blood vessels the utility of non-invasive monitoring systems is not shown yet. But~     principally this group with a high level of comorbidity might profit notably from less~     invasive procedures. This is the reason for the planed research.~   "
29713|NCT03178084|"~     A low CD4/CD8 ratio is considered a surrogate marker of immunosenescence and is an~     independent predictor of non-AIDS-related morbidity and mortality. Given the strong clinical~     implications the impact of different regimens on the CD4/CD8 ratio recovery needs to be~     analyzed. The MERIT study is a completed a randomized, double-blind, multicenter phase~     IIb/III study with an open-label extension phase (240-week follow-up) to assess the efficacy~     of zidovudine/lamivudine in combination with maraviroc (MVC) or efavirenz (EFV) in~     treatment-naïve patients. Anonymised patient level data of the MERIT trial to compare the~     trajectories of the CD4/CD8 ratio of participants treated with maraviroc vs. efavirenz will~     be used.~   "
29714|NCT03178071|"~     This expanded access study has being designed following a demand from the FDA, given the~     increase in the number of request for single patient INDs for lorlatinib~   "
29715|NCT03178058|"~     In this study we would like to identify demographic and individual risk factors that place~     parturients at a higher risk for postoperative nausea and vomiting (PONV) and itching~     following administered neuraxial morphine for cesarean section. Our primary objective is to~     develop a reliable predictive neuraxial morphine induced nausea and vomiting (NMINV) and~     itching model.~   "
29716|NCT03178045|"~     The aim of this study is to understand and improve the experience of patients after surgery~     by comparing two methods of following symptoms while the patient recovers at home.~   "
29717|NCT03178032|"~     Oncolytic adenovirus for pediatric naive DIPG, to be infused after tumor biopsy through the~     same trajectory in the cerebellar peduncle.~   "
29718|NCT03178019|"~     Dipeptidyl peptidase 4 (DPP4) is a serine exopeptidase able to inactivate various~     oligopeptides involved in inflammation, immunity and vascular function. Our aim was to~     investigate the associations between constitutive levels of DPP4 activity and inflammatory~     biomarkers, skin microvascular reactivity, gut peptides, insulin resistance indexes, heart~     rate and blood pressure variability, and measures of adiposity in subjects with different~     grades of glucose tolerance.~   "
29720|NCT03177993|"~     Lymphatic Filariasis (LF), scabies and soil transmitted helminths (STH) are common neglected~     tropical diseases affecting the people of Fiji. There is a dedicated LF eradication program~     supported by the World Health Organization (WHO), however scabies and STH are currently~     managed on an individual level with symptomatic treatment as required.~      In an attempt to reduce the prevalence of LF globally, research is being undertaken into~     alternative, more effective treatment options. A recent study in Papua New Guinea~     demonstrated a new triple drug therapy (ivermectin, diethylcarbamazine and albendazole) is~     superior to the currently recommended two drug therapy (diethylcarbamazine and albendazole)~     used by WHO LF programs in the Pacific. However, adverse events were more frequent. Despite~     no serious adverse events being observed, it is necessary to conduct further studies to~     review the safety of this new triple therapy before it can be endorsed as an effective mass~     drug administration (MDA) regimen for LF in endemic countries. Fiji's burden of LF, that has~     been recalcitrant to previous MDA with diethylcarbamazine and albendazole, make it an ideal~     site to obtain further efficacy and safety data of the triple therapy.~      Ivermectin given to communities as MDA has been proven to be effective in reducing the~     community prevalence of scabies. What is not known is the effects of one dose versus two~     doses of ivermectin as MDA. This question will be reviewed within the design of the community~     randomized study. The prevalence of impetigo in a community is linked to scabies and this~     will also be reviewed. Ivermectin and albendazole are both effective individually against~     STH. The effectiveness of this combination of treatment as MDA in Fiji for STH has not been~     studied. The effectiveness for the individual in the short-term and the community in the~     longer-term will be reviewed.~      In addition, the acceptability and feasibility of the new therapy in communities at risk of~     these three diseases will be reviewed.~   "
29721|NCT03177980|"~     A prospective pharmacokinetic (PK), pharmacodynamic (PD) and pharmacogenetic (PG) observation~     study, including the PK/PD/PG relationship, in fentanyl and clonidine administered for~     analgesia and sedation to term newborn asphyxiated infants receiving hypothermic treatment in~     the NICU.~   "
29722|NCT03177967|"~     A randomized, controlled study to examine the effect of group treatment for insomnia (CBT-I)~     in an outpatient clinic compared with waiting list and treatment-as-usual (sleep-hygiene~     based educational course)~   "
29723|NCT03177954|"~     There is a need to improve the discharge process for patients with stroke, which has been~     reported to be a particularly stressful time for patients. A Patient Oriented Discharge~     Summary (PODS) meeting has been shown to be an effective approach for minimizing~     discharge-related stress and fostering self-management skills in other patients being~     discharged from rehabilitation into the community. The purpose of this study is to develop~     and evaluate whether a PODS meeting can minimize stress around the discharge process and~     improve patient satisfaction with this process. There are two main hypotheses regarding the~     PODS program: 1) it will help in-patients with stroke understand key issues related to~     knowledge required once discharged and 2) it will increase levels of self-efficacy in~     in-patients with stroke. Potential subjects are encouraged to participate if they are a~     Sunnybrook - St. John's Rehab admitted in-patient with a stroke diagnosis who are 18 years or~     older and meet the following criteria: (a) fluent in English; (b) cognitively intact; and (c)~     have minimal or no aphasia.The participant will be asked to answer some surveys 8-10 days~     prior to discharge about their knowledge and confidence in managing their stroke.~      The participant will then be asked to meet with a clinical staff member who will hold a~     one-hour PODS meeting. In the meeting, a discharge plan will be created and given to the~     patient that covers a number of topics that will be useful following their return to the~     community. One day following the PODS meeting, the participant will be asked to answer the~     same survey they completed prior to the PODS and again 3-5 days following discharge. If the~     participant is interested they will be asked to undergo a brief interview to get their~     feedback on the PODS Program. It is anticipated that about 20 people will participate in the~     program with all 20 patients completing the surveys with 6 being asked to complete the brief~     interview.~      To the best of the investigators knowledge, there is little risk associated with this study.~     Participants may become uncomfortable during the interview while discussing their~     experiences. By participating in this study, patients will be provided with a chance to~     gather information and learn problem solving and self-management skills prior to discharge.~     It is the hope of this project that it can lead to a more effective approach in supporting~     the transition from the hospital to the community for patients with stroke~   "
29724|NCT03177941|"~     The proposed study builds upon the success of our research program (STU00017005:~     Interventions to teach melanoma patients skin self-examination and the continuation~     STU0201983) designed to increase early detection of melanomas before they metastasize. This~     study seeks to expand the use of our efficacious skin self-examination (SSE) training program~     to first-degree relatives with automated support with reminders and the dermatologist~     coaching about pictures of moles submitted by user. In 2015 there are more than 1 million~     living melanoma patients in the United States (US), and almost 500,000 were age 40-60 years.~     If each melanoma patient has 2.79 first-degree relatives (children, and siblings of melanoma~     patients), then there are 2.79 million first-degree relatives and 1 million melanoma patients~     or 3.79 million people at-risk to develop melanoma, who are predominantly non-Hispanic White.~     A first-degree relative (FDR) is the parent, sibling or child of a melanoma patient. In 2015,~     approximately 73,870 individuals in the US will be diagnosed with invasive melanoma and about~     9,940 will die from the disease. People with a history of melanoma have 10 times greater risk~     of developing a second new melanoma relative to the general population. A first-degree~     relative of a melanoma patient (parent, child, sibling) has an 8 times greater chance of~     developing melanoma. Early detection with surgical excision at an early stage when treatment~     is usually more effective is the only proven curative strategy. Thus, enhanced surveillance~     for melanoma patients and screening for their first-degree relatives, who have the same skin~     type (skin that easily sunburns) and melanoma-risk habits (sunny vacations) as the melanoma~     survivor, has the potential to detect melanomas in the early stages where treatment prognosis~     is optimal. Indeed, several societies recommend routine screening by a physician for persons~     with a family history of melanoma.~   "
29725|NCT03177928|"~     Myeloproliferative neoplasms are heterogeneous group of clonal hematopoietic stem cell~     neoplasms with excessive proliferation of one or more of the erythroid, megakaryocytic, or~     myeloid lineages and relatively normal maturation resulting in increased numbers of red~     cells, platelets, and/or granulocytes in the peripheral blood. Constitutive tyrosine kinase~     activation appears to be a common pathogenetic mechanism.~   "
29726|NCT03177915|"~     Carpal tunnel syndrome (CTS) is a common peripheral entrapment neuropathy, this study aims to~     investigate if, and to what extent, hydro-dissection using 1% lidocain followed by Sodium~     hyaluronate versus 40 mg of triamcinolone acetonide, ultrasonic guided~   "
29727|NCT03177902|"~     Breast cancer is one of the most common cancers in China. Even though advances in the field~     of breast cancer therapeutics, chemotherapy remains the mainstay therapeutic modality. The~     cytotoxic therapies are generally associated with some immediate or otherwise delayed side~     effects, such as adverse effects on gastrointestinal, hepatic, renal and hematological~     systems. The effect of chemotherapy on endocrine system, however, is comparatively less~     envisaged. Several epidemiological studies show a positive association between plasma thyroid~     hormones levels and breast cancer risk. Thyroid dysfunction is emerging as a variably common~     endocrine toxicity of several anticancer drugs. Due to the scarcity of data on the~     functioning of thyroid gland during chemotherapy in a large scale group, the present study~     was aimed to investigate the incidence of thyroid abnormity in Chinese women with newly~     diagnosed breast cancer, and also the effects of chemotherapy on thyroid gland functions or~     structure in these breast cancer patients undergoing at least four cycles of chemotherapy.~   "
29766|NCT03177395|"~     Investigate the safety and tolerability of PP100-01 add-on treatment to the 12hr NAC~     treatment regime in patients treated for paracetamol/acetaminophen overdose (POD) when NAC~     treatment is initiated before 24hours post POD.~   "
29950|NCT03175003|"~     The current study conducted will lend toward the optimization of the development of a food~     product that will promote a shift towards improved metabolic health. Specifically, this trial~     will determine the optimal level of protein needed to elicit positive changes in markers of~     inflammation, metabolic and micronutrient status, hepatic lipid metabolism, vascular~     function, and the relationship of these changes to the metabolome in school aged children (9~     - 13 years of age).~   "
29728|NCT03177889|"~     Bronchiectasis is a chronic airway disease which confers significant healthcare burden, with~     limited therapeutic approaches. From the perspective of traditional Chinese medicine,~     congenital insufficiency of the lung, spleen and kidney, when coupled with external injury or~     mood impairment, may collectively contribute to bronchiectasis pathogenesis due to heat~     trapping in the phlems, congestion of wind evils and stagnation of blood. Symptomatic~     treatment may be effective and safe for ameliorating respiratory symptoms and hindering~     disease progression of bronchiectasis. Here, the investigators have explored the Lung~     Dispersing, Turbid Descending and Gut Clearing Decoction (LTGD) which targets at expelling~     the wind evil in patients with bronchiectasis. The investigators sought to conduct a~     multicenter, randomized cross-over trial which investigates the efficacy and safety of LTGD~     on clinically stable bronchiectasis.~   "
29729|NCT03177876|"~     twenty recruited patients indicated for sinus augmentation and immediate implant placement~     will be divided into two groups (10 in each of the two groups), to compare bone formation and~     implant stability after shneiderian membrane elevation and augmentation with Hydroxyapatite~     Nano particles [Nanostreams] or augmentation with graft less tenting technique with~     simultaneous implant placement.~   "
29730|NCT03177863|"~     In the Swedish organised cervical screening program precursors of cervical cancer are~     detected and treated. Most precursor lesions detected by screening heal spontaneously. Those~     who progress do it slowly. There are three levels from light; CIN1, moderate; CIN2 to severe;~     CIN3. Women with CIN3 are always treated, regardless of age, according to current clinical~     guidelines. Women with CIN2 who are below the age of 25 years are offered active expectance~     for up to two years because there is good evidence that they will spontaneously heal their~     lesions (regression) in 40-70% of the cases during that time.~      Method of treatment is today an excisional procedure of the cervix most often by Large loop~     excision of the transformation zone (LLETZ/LEEP) Treatment increases the risk of premature~     birth in a future pregnancy. In 2015 about 1800 excisional procedures of the transformation~     zone of the cervix were performed in the Västra Götalands regionen (VGR) om Sweden. The~     average age of first-time mothers in Sweden is rising and in 2014 it was 29 years. Postponed~     childbearing raises the question whether it is possible to refrain from surgery even for the~     group of women over 25 years old, with proven CIN2. Existing studies suggest that cure of~     CIN2 in the age group of and above 25 takes place in the same extent as under 25 years of~     age.There is lack of evidence concerning clinical follow-up.~      In a prospective multicenter clinical cohort study (observational study) with careful~     monitoring, the investigators will examine what proportion of CIN2 changes regress~     spontaneously within two years in women, 25-30 years old, and if human papillomavirus (HPV)~     type 16 may can be a marker for poor regression in this group. Instead of LLETZ, active~     expectance is offered to women this age with CIN2 in five gynecological clinics in VGR. The~     study protocol includes gynecologist visits every 6 months for two years, including cytology,~     colposcopy and directed biopsies of the cervix. Power calculation shows 160 women needs to be~     included, which is expected to occur within one year from the start.~   "
29731|NCT03177850|"~     In this trial, the investigators will evaluate the effect of acetazolamide (375 mg per day)~     vs. placebo on sleep related breathing disturbances at altitude in patients with COPD.~   "
29732|NCT03177837|"~     In this trial, the investigators will evaluate the effect of acetazolamide (375 mg per day)~     vs. placebo on exercise performance at altitude in patients with COPD.~   "
29733|NCT03177824|"~     The aim of this study is to assess the effect of Sildenafil citrate therapy on neonatal~     outcomes in women with fetal growth restriction.~   "
29734|NCT03177811|"~     In this trial, the investigators will evaluate the effect of acetazolamide (375 mg per day)~     vs. placebo on postural control at acute altitude exposure in patients with COPD.~   "
29735|NCT03177798|"~     The overarching goal of this study is to determine the role of chronic kidney disease and the~     activation of the kallikrein-kinin system during hemodialysis on the development of~     mitochondrial dysfunction; the investigators will measure mitochondrial function using the~     gold standard method, 31-phosphorus magnetic resonance spectroscopy.~      The investigators will test the hypothesis that endogenous bradykinin promotes mitochondrial~     dysfunction in patients undergoing hemodialysis. The investigators will first perform a~     randomized, placebo-controlled, double-blind, cross-over study measuring the effect of~     Icatibant (HOE-140), a bradykinin B2 receptor blocker, on mitochondrial function.~   "
29736|NCT03177785|"~     This study aims to test the efficacy of the EverydayMatters Multiple Sclerosis (MS) program~     for individuals age 45 or older living with multiple sclerosis. The program involves a 6-week~     telephone-delivered program to promote resilience and happiness for individuals living with~     MS.~   "
29737|NCT03177772|"~     The investigators are adapting Complicated Grief Group Therapy (CGGT) for soon-to-be bereaved~     dementia caregivers at risk for complicated grief—Pre-Loss Group Therapy (PLGT) to facilitate~     healthy death preparedness and eventual bereavement. This will be the first known application~     of proven therapeutic strategies to address complicated grief applied to high-risk dementia~     caregivers prior to care recipient death to mitigate complicated grief. If proven to be~     effective in attenuating poor bereavement outcomes, PLGT could be translated into~     comprehensive caregiver support programs and delivered to active caregivers of living persons~     with dementia at risk for complicated grief through community-based caregiver support groups.~   "
29738|NCT03177759|"~     This is a prospective evaluation to determine the effectiveness of the Prostate Cancer~     Supportive Care (PCSC) Program's group therapy program, Living with Prostate Cancer (LPC).~     LPC is an intervention which utilizes a small group format (5-7 participants with 2 leaders~     and a paraprofessional counselling student) to understand and learn how to manage emotional~     responses, depressive symptoms, and life stressors associated with prostate cancer. Data for~     this evaluation will be derived from a focus group (at 3 months) and self-report~     questionnaires that participants will complete immediately prior to the intervention,~     immediately following the intervention and at 3, 6, and 12-months post-intervention.~   "
29739|NCT03177746|"~     The purpose of this study is to evaluate the safety and efficacy of Dapoxetine/Tadalafil~     30/20 mg film-coated tablet in the treatment of men with premature ejaculation and erectile~     dysfunction.~   "
29740|NCT03177733|"~     This study evaluates the efficacy of the the pecto-intercostal fascial plane block (PIF~     block) for the anesthesia of the intercostal nerves anterior branches and assesses the~     association of the serratus block with a PIF block for the breast surgery.~      To obtain a correct prospective clinical trial completion we have to begin a new series of~     inclusion.~   "
29741|NCT03177720|"~     The investigators will determine the difference of pharmacokinetics of ciprofloxacin and~     imipenem between healthy volunteers and intensive care patients suffering from pneumonia in~     plasma and at the target site - lung - using bronchoalveolar lavage. As additional aspect the~     feasibility of combining microdosing of C14 ciprofloxacin with microdialysis, saliva sampling~     and bronchoalveolar lavage is studied by comparing pharmacokinetics of microdose and~     macrodose.~   "
29743|NCT03177694|"~     Aging of the population is dramatically increasing the number of hospitalized patients, with~     the consequent challenges of limited medical personnel and resources in hospitals. Wireless~     technologies that create highly connected healthcare environments are developed to help~     hospitals address these issues, once these technologies are perfectly integrated in the~     hospital environment with respect to IT infrastructure for big data storage. Such devices~     have proven remarkable efficiencies in monitoring patients with high patient safety, data~     accuracy and security, which are essential to provide high quality patient care, reduce~     health-related costs and optimize the management of high numbers of patients.~      Cough is the most common condition that results in a visit to the physician. Often coughs are~     benign, but sometimes can be the sign of exacerbations of a chronic respiratory disease.~     Exacerbations are defined in the Global Initiative for Chronic Obstructive Lung Disease~     (GOLD) document as an acute event characterised by a worsening of the patient's respiratory~     symptoms that is beyond normal day-to-day variations and leads to a change in medication. It~     is assumed that, if coughs were remotely monitored, hospitals might be unburdened, patients~     would be empowered to self-manage their health, and that prevention of serious respiratory~     diseases might be facilitated, thus improving health outcomes. Unfortunately, remote~     monitoring for cough that rely on self-reporting is impractical, as patients do not record~     data very reliably. On the contrary, a bed sensor under the mattress connected to a medical~     data analysis platform might monitor patients' micro-movements at night and alert the medical~     staff as soon as there is a cough exacerbation.~   "
29744|NCT03177681|"~     The goal of this clinical research study is to learn if probiotics found in yogurt can help~     to decrease gastrointestinal (GI) symptoms in cancer patients. Probiotics are live bacteria~     and yeast that help with many of our functions and may help digestive problems. Researchers~     also want to learn if the bacteria in your stool change as your symptoms change while eating~     yogurt.~   "
29745|NCT03177668|"~     The purpose of this study is to examine tolerability, safety, and pharmacokinetics of YS110~     intravenous administration in patients with malignant pleural mesothelioma and to~     preliminarily examine the anti-tumor effect of YS110.~   "
29746|NCT03177655|"~     This single-center interventional study quasi-randomly allocated patients to a guided imagery~     or control intervention (positive journaling). Data were analyzed with treatment allocation~     masked.~   "
29747|NCT03177642|"~     The purpose of this research is to investigate multiple facets of non-traumatic and traumatic~     orthopaedic health issues. Studies under this protocol will investigate a variety of research~     questions concerning traumatic and non-traumatic health issues in the Orthopaedic Hand and~     Upper Extremity Service.~   "
29748|NCT03177629|"~     The purpose of this study is to determine the efficacy of H. pylori eradication for the~     treatment of chronic or persistent immune thrombocytopenic purpura (ITP) patients with~     moderate thrombocytopenia. This is a multi-center, open label, prospective randomized phase~     IIl study.~   "
29749|NCT03177616|"~     This pilot study evaluates the addition of chiropractic treatment to conventional~     neurological care in the treatment of migraine headaches in adult women. Half of the~     participants will receive 10 chiropractic treatments in addition to their usual care over a~     14 week period, while the other half will continue their usual medical care alone, as~     prescribed by their physician during that time period.~   "
29750|NCT03177603|"~     GSK2586881, a purified intravenous (IV) formulation of soluble recombinant human Angiotensin~     Converting Enzyme (rhACE2) is being investigated as a treatment for PAH. This GlaxoSmithKline~     (GSK) study will evaluate the safety, tolerability, pharmacokinetics (PK) and~     pharmacodynamics (PD) of GSK2586881 in subjects with PAH. This open-label, dose-escalation~     study will comprise of 4 separate groups based on the planned dose range, and subjects in~     each group will be administered a single dose of GSK2586881 ranging between 0.2, 0.4, 0.8, or~     1.2 milligram per kilogram (mg/kg) via IV route. Dose escalation will occur after 4 subjects~     have been dosed per cohort and review of safety, tolerability, PK and hemodynamic data up to~     24 hours post dose has taken place. A maximum of 27 subjects will be included in the study~     and the total duration of the study will be up to a maximum of 59 days.~   "
29751|NCT03177590|"~     The purpose of the JEMImE project is to create a serious game to help children with Autism~     and Pervasive Developmental Disorder (PDD) develop facial and vocal emotions in context.~      The objective of this study is to record facial and vocal emotional productions in children~     with autism and PDD in order to create an algorithm for the recognition of facial emotional~     expressions implemented in the serious game JEMImE.~   "
29752|NCT03177577|"~     To determine the effect of first dorsal interosseus (FDI) strengthening in patients with~     thumb carpometacarpal (CMC) osteoarthritis.~   "
29753|NCT03177564|"~     This study aims to investigate the feasibility of a driving pressure limited mechanical~     ventilation strategy compared to a conventional strategy in patients undergoing one-lung~     ventilation during Video-assisted thoracoscopic lobectomy.~   "
29754|NCT03177551|"~     This is an observational, prospective (study following participants forward in time),~     multi-center (study conducted in more than 1 center) study to identify the risk factors, then~     develop and validate the predictive Nomogram of metastatic castration-resistant prostate~     cancer (mCRPC) that will effectively predict the early onset mCRPC in patients receiving~     androgen-deprivation therapy (ADT). The entire duration of study will be approximately 3~     year. Participants will primarily be evaluated for achieving biochemical or radiological~     progression after receiving ADT based on EAU 2017 practice guideline criteria. Serum~     testosterone, prostate specific antigen (PSA), alkaline phosphatase (ALP) and blood routine~     will be monitored throughout the study.~   "
29755|NCT03177538|"~     In an opened randomized study of women undergoing in vitro fertilization with expected~     suboptimal response to controlled ovarian stimulation (Poseidon Group 2b) investigators will~     examine clinical efficacy and safety of two stimulation protocols: Corifollitropin alfa~     (Elonva) in combination with menotropin (Merional) versus Follitropin alfa and lutropin alfa~     (Pergoveris).~   "
29814|NCT03176771|"~     The purpose of this study is to evaluate the efficacy and safety of MT-5199 administered once~     daily for the treatment of Tardive Dyskinesia (TD) symptoms.~   "
29815|NCT03176758|"~     Total knee arthroplasty may be conducted either under general anesthesia or spinal block.~     previous studies have shown that spinal block leads to less complications. The investigators~     aim to find whether post-operative pain is also diminished under spinal block compared to~     general anesthesia~   "
29756|NCT03177525|"~     Children with autism spectrum disorder (ASD) exhibit characteristic deficits in social~     initiation and there are no empirically validated treatments specifically for this core~     deficit. While parent training is known to be a critical intervention component, few social~     skills programs involve parents. This study will capitalize on an existing social skills~     group already established at the community agency Abilities United, with the goal of~     enhancing the program's effectiveness by adding a parent component. Specifically, the~     proposed study will investigate whether a novel parent mediated social skills program (Social~     SUCCESS), which provides parent training in conjunction with a social skills group~     intervention, will result in more frequent initiations during play with typically developing~     peers. Participants will include 50 children with ASD age 4:0 to 6:11 years. Children will be~     randomly assigned to either Social SUCCESS (N=25) or waiting list (N=25). Treatment will be~     provided for 8 weeks during a weekly 120-minute social skills group at Abilities United. The~     study will evaluate the effects of Social SUCCESS on areas of core social deficit including~     frequency of peer initiations using parent ratings, observational measures, standardized~     questionnaires, and a social eye tracking task. Outcomes will be compared to a waiting list~     control group. Findings will be disseminated through presentations and publications to aid~     clinicians in providing more effective social skills treatment for children with ASD and to~     enhance the scientific knowledge-base related to evidence-based social skills treatments.~     This research designed with the goal of stimulating additional scientific inquiry in the area~     of treatment for core social deficits in ASD and will provide a strong foundation for larger~     scale grants to study motivation-based interventions to improve social functioning.~   "
29757|NCT03177512|"~     This study is testing the acceptability and feasibility of a highly interactive mobile~     application (app) to promote accurate risk perception and increase HIV and sexually~     transmitted infection (STI) testing and linkage to care among young men who have sex with men~     (YMSM).~   "
29758|NCT03177499|"~     Portal pressure gradient (PPG) above 12 mmHg after transjugular intrahepatic portosystemic~     shunt (TIPS) increases the risk of portal hypertension complications. Currently, a PPG~     reduction <12 mmHg after TIPS is the most consistent threshold associated with almost~     complete protection from variceal bleeding and ascites. However, the measurement of PPG~     requires an invasive procedure. A recent study investigated the variations in PPG~     measurements collected at different time points after placement of TIPS and demonstrated that~     a time point of at least 24 hours after which PPG values were best maintained (early PPG). It~     is of great clinical value to propose that an immediate PPG measurement fail to accurately~     identify the risk of decompensated event. And early PPG would change the decision making for~     re-intervention or not. However, the repeated invasive examination is extremely difficult to~     follow in clinical practice worldwide. The prospective multicenter trial aims to assess the~     diagnostic performance of a virtual imaging-based early portal pressure gradient (vePPG)~     (investigational technology) from CT angiography and Doppler ultrasound with invasive early~     PPG measurement as reference. The study participants with portal hypertension will be~     prospectively recruited at 10 high-volume liver centers in China.~   "
29759|NCT03177486|"~     Patients with coronary artery disease (CAD) were enrolled. CAD was diagnosed by coronary~     angiography which also resulted Syntax score. Images of left and right ears were captured by~     a digital camera. Frank score of each patients was calculated based on characteristics and~     numbers of wrinkles of the earlobes. Statistic analysis were carried out to analyze the~     correlation between Frank Score and Syntax Score.~   "
29760|NCT03177473|"~     This study examines the effect of adjunctive use of the CervicalStim bone growth stimulator~     on cervical fusion rate in high risk subjects who have undergone cervical fusion surgery. All~     participants will wear the bone growth stimulator every day for 4 hours/day for 6 months.~   "
29761|NCT03177460|"~     The goal of this clinical research study is to learn about the safety and tolerability of~     giving Darzalex (daratumumab) or JNJ-527 (JNJ-40346527) to patients who have prostate cancer~     before having an already-scheduled prostatectomy (surgical removal of the prostate).~      Researchers also want to learn if daratumumab or JNJ-527 can help to control the disease~     before the prostatectomy.~      This is an investigational study. Daratumumab is FDA approved and commercially available to~     treat multiple myeloma. It is considered investigational to use daratumumab in patients with~     prostate cancer. JNJ-527 is not FDA approved or commercially available. It is currently being~     used for research purposes only.~      The study doctor can explain how the study drugs are designed to work.~      Up to 30 participants will be enrolled in this study. All will take part at MD Anderson.~   "
29762|NCT03177447|"~     Background: Early palliative care (EPC) is recommended but rarely integrated with advanced~     heart failure (HF) care. This pilot study engaged patients and family caregivers to study the~     feasibility and site differences in a two-site EPC trial, ENABLE CHF-PC (Educate, Nurture,~     Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers).~      An EPC feasibility study (4/1/14-8/31/15) was conducted for patients with New York Heart~     Association (NYHA) Functional Class III/IV HF and their caregivers in academic medical~     centers in the northeast and southeast U.S. The EPC intervention comprised: 1) an in-person~     palliative care consultation; and 2) telephonic nurse coach sessions and monthly calls.~     Patient- and caregiver-reported outcomes were collected for quality of life (QOL), symptom,~     health, anxiety, and depression outcomes at baseline, 12- and 24-weeks. Linear mixed-models~     were used to assess baseline to week 24 longitudinal changes. The intervention was tailored~     to rural, older adults (age≥65) with advanced HF in reducing HF morbidity and improving~     patient and caregiver QOL and quality of care.~   "
29763|NCT03177434|"~     Assessment of efficacy of Dicopeg Junior, compared to lactulose, in the treatment of~     functional constipation in children aged 6 months to 6 years. The basis of assessment is to~     compare the number of commissioned stools (more than three stools per week) and stool~     consistency according to the scale of Bristol, in children taking Dicopeg Junior and children~     treated with lactulose. Childrens who meet the inclusion criteria will be randomized to one~     of two groups, in which the treatment will be as follows for 12 weeks:~        1. The first group - Dicopeg Junior (max. in 2 doses) in a dose of:~             -  weight up to 8 kg - 1 sachet per day~             -  weight 8 - 12 kg - 2 sachets a day~             -  weight 12 - 20 kg - 3 sachets a day~             -  weight> 20 kg - 4 sachets per day,~        2. The second group - Lactulose at 2 ml / kg / day (in two doses). Preparations: Dicopeg~          Junior and Lactulose will be administered orally for the duration of the study (12~          weeks).~   "
29764|NCT03177421|"~     The objective of this study is to use health information technology to implement and evaluate~     a counseling recommendation for children who suffer from problematic sleep associated with~     bedtime media use. Participants will be randomized by clinic to be screened for basic sleep~     concerns and receive appropriate counseling, or to be screened for sleep concerns and media~     use, and receive appropriate counseling.~   "
29765|NCT03177408|"~     This study evaluated the association between HMGB1 and diastolic dysfunction in hypertensive~     patients. HMGB1 level were tested in all patients, and diastolic function determined by~     echocardiographic.~   "
29767|NCT03177382|"~     Purpose:To compare the efficacy and the safety of total neoadjuvant chemotherapy + TME with~     standard neoadjuvant concurrent chemoradiotherapy + TME + adjuvant chemotherapy for locally~     advanced rectal cancer patients with high risk factors of recurrence.~      Evaluation indexes: (1) the primary evaluation index: disease-free survival (disease free~     survival, DFS); (2) the secondary evaluation indexes: pathological complete remission rate~     (pCR), the 3 year overall survival (overall survival, OS); R0 dissection rate; distant~     metastasis free survival (DMFS); local recurrence free survival rate (LRRFS); tumor~     regression grade (TRG, tumor regression grade) and the adverse reaction rate during the~     chemotherapy, the operation safety index; quality of life; psychological and cognitive~     effects, assessment of nutritional status.~      Safety evaluation indexes: including all adverse events observed during the experiment.~      Number of patients: 458 cases Study design: patients will be randomly assigned into the total~     neoadjuvant treatment group (experimental group, TNT) and neoadjuvant concurrent chemotherapy~     group (control group, CRT) in the ratio of 1: 1. The patients of experimental group will be~     given 1 cycle of induction CAPOX (Oxaliplatin 130mg/m2 d1, Capecitabine 1000mg/m2, bid,~     d1-14) prior to radiotherapy. Then pelvic IMRT/VMAT (50-50.4Gy/25-28f) and two cycles of~     concurrent chemotherapy (Oxaliplatin 130mg/m2, d1, d 22, Capecitabine 825mg/m2, bid, 5d/w,~     25-28d) are performed. And three cycles of consolidation chemotherapy (CAPOX) are delivered~     after concurrent chemoradiotherapy. Total mesorectal excision (TME) is performed after~     completion of the whole neoadjuvant treatment. The patients of control group will receive~     standard concurrent neoadjuvant chemoradiotherapy with capecitabine (825mg/m2, bid, 5d/w)~     followed by TME 6-8 weeks after the end of concurrent chemoradiotherapy. Then, patients are~     treated with another 6 cycles of CAPOX.~      Schedule: Investigators plan to finish the study in 4 years and write the related work within~     2 years after the completion of this study.~   "
29768|NCT03177369|"~     Staphylococci represent the first etiologic agents of bone and joint infection (BJI), leading~     glycopeptides use, especially in case of methicillin-resistance or betalactam intolerance.~     Teicoplanin may represent an alternative to vancomycin because of its acceptable bone~     penetration and possible subcutaneous administration. Various studies have shown that~     teicoplanin pharmacodynamic profile was superior compared to vancomycin regarding bone~     diffusion. Few studies have investigated the use of teicoplanin in BJI, particularly through~     subcutaneous administration.~      The aim of this study assesses the efficacy and tolerance of teicoplanin in S. aureus BJI,~     especially focusing on subcutaneous use. This study is a retrospective single-center~     observational cohort study (2001 to 2011) including all consecutive patients managed at our~     institution receiving teicoplanin as part of S. aureus BJI treatment.~   "
29769|NCT03177356|"~     20 recruited patients indicated for immediate implant placement in mandibular molar patients~     are divided into 2 groups each group contain 15 patients, one group assigned for placement of~     bovine bone after molar extraction and immediate implant placement, while the other group we~     use Platelet-rich fibrin as space filling material.~   "
29770|NCT03177343|"~     Staphylococcus aureus represents the leading pathogen implicated in bone and joint infection~     (BJI), usually requiring prolonged combination antimicrobial therapy, which may be~     particularly challenging in the case of MDR bacteria and/or for patients with multiple drug~     intolerance. In the absence of new well-tolerated oral antistaphylococcal drugs, older~     antibiotics must be considered, such as the pristinamycin.~      However, pristinamycin is not currently licensed for treatment of staphylococcal BJI and lack~     of clinical data prevents it from being considered as a reliable alternative therapeutic~     option in current guidelines.~      The aim of this study is to evaluate pristinamycin (efficacy and tolerance) in the treatment~     of MSSA bone and joint infection (BJI).~   "
29771|NCT03177330|"~     Polymyxin B hemoperfusion (PMX-HP) is mainly used to remove endotoxins in septic shock~     patients with intra-abdominal infections. Because of the concerns of postoperative bleeding,~     physicians may hesitate to use anticoagulation in patients with septic shock within a few~     hours after an abdominal operation. We developed a heparin dosing score protocol for heparin~     dosage adjustment. The purpose of the study is to examine the safety and efficacy of the~     heparin dosing score protocol.~   "
29772|NCT03177317|"~     Feasibility study to evaluate the efficacy of reduced prophylactic dose of dexamethasone in~     elderly patients receiving moderate emetogenic chemotherapy~   "
29773|NCT03177304|"~     The National Institutes of Mental Health has identified the use of empirically based mental~     health treatments (i.e., treatments with research supporting efficacy) as a priority, yet~     there is a shortage of clinicians trained in these approaches. This study develops an on-line~     therapist training program for Interpersonal Psychotherapy (IPT), a particularly~     well-researched yet particularly little disseminated, empirically based treatment, in order~     to facilitate wider dissemination of this approach.~   "
29774|NCT03177291|"~     The purpose of this study is to find out what effects (good and/or bad) Pirfenidone combined~     with standard first-line chemotherapy will have on you and non-small cell lung cancer~     (NSCLC). The investigational drug Pirfenidone is being combined with standard chemotherapy in~     participants with advanced non-small cell lung cancer. Pirfenidone is approved to treat~     idiopathic pulmonary fibrosis (IPF) but it isn't currently approved to treat non-small cell~     lung cancer.~   "
29775|NCT03177278|"~     This is a single-center, open label, non-randomized metabolism, excretion, and mass balance~     study of a single IV infusion of [14C]-plazomicin in healthy, adult male subjects.~   "
29776|NCT03177265|"~     Tobacco-related diseases account for a significant portion of all VA healthcare costs and are~     a detriment to the health and quality of life of our Veterans. Despite progress in~     instituting tobacco screenings and treatment referral, most Veterans still do not receive the~     most effective strategy to help them quit smoking - pharmacotherapy combined with behavioral~     coaching. This study builds on findings from population health and mobile interventions to~     help more Veterans receive evidence-based tobacco treatment. The investigators propose to~     test the effect of two types of text messaging in combination with telephone cessation~     counseling: 1) pre-counseling text messages to increase enrollment in counseling, and 2)~     ongoing texts for those who start counseling that provide appointment reminders and support~     between sessions to increase adherence to counseling. This study supports multiple goals of~     the VA's Blueprint for Excellence. Results will directly inform decision-making and~     population-based care models for tobacco treatment.~   "
29777|NCT03177252|"~     Making sure the heart rate and or the blood pressure [called hemodynamic instability] during~     surgery is stable, setting up for a rapid postoperative recovery, and ensuring that patients~     have adequate pain relief are some of the important goals of neurosurgical anesthesia. Scalp~     block anesthesia [injection of a numbing agent into the area of the scalp where the incision~     will be] together with general anesthesia is used to achieve these goals. There has been some~     research on whether or not scalp block improves patient recovery and pain management, but the~     studies have not be large enough to say for certain. This is true even though scalp block is~     used with almost every patient that is having brain surgery. The investigators propose to~     determine if scalp block in combination with asleep anesthesia is better than asleep~     anesthesia alone in patients who are having brain surgery for tumors in the cerebral area of~     the brain.~   "
29778|NCT03177239|"~     This study aims to evaluate the safety, tolerability and effectiveness of new treatments for~     kidney cancer called Nivolumab and Ipilimumab. The study is in two parts; in the first~     instance patients receive nivolumab alone. If this treatment is not effective patients may~     move onto the second part of the trial, where they receive nivolumab + ipilimumab. There is~     no placebo.~      The reason to offer one treatment alone, followed by two treatments together is that it is~     thought that the double treatment may have more side-effects, but also may be effective in~     people in whom the single first treatment (nivolumab alone) has not helped.~      Nivolumab and ipilimumab are experimental treatments. This means that they are not an~     approved treatment for non-clear cell kidney cancer in Australia.~      The purpose of this study is to test the effectiveness, safety, and tolerability of Nivolumab~     (also known as Opdivo or BMS-936558) and Ipilumumab (also known as MDX-010 or Yervoy).~     Nivolumab and ipilimumab are antibodies (a type of human protein) that are being tested to~     see if they will allow the body's immune system to work against tumour cells. The immune~     system is the body's defence against cancer, bacteria and viruses. The effectiveness of~     nivolumab and ipilimumab in cancer of the kidney will be assessed by measuring the size of~     patient tumours via CT scans.~      Nivolumab and ipilimumab have been used alone or in combination in many other cancers, and~     are licenced for use in other cancers like advanced melanoma and bladder cancer in Australia.~     They have not been tested in people with non-clear cell kidney cancer.~      About 85 participants with non-clear cell kidney cancer are expected to participate in this~     study, from Australia and New Zealand.~      This research study has been initiated by Dr. Craig Gedye, is being conducted in~     collaboration with the Centre for Biostatistics and Clinical Trials (BaCT) and sponsored in~     Australia by the Australian and New Zealand Urogenital and Prostate (ANZUP) Cancer Trials~     Group Pty Ltd. Bristol Myers Squibb (BMS) is supplying the study drugs and grant funding for~     this research.~   "
29779|NCT03177226|"~     Prospective, non-randomized, controlled, single-center study, to evaluate the efficacy of~     applied nominal electrical stimulation parameters given to premature ejaculation (PE)~     patients in order to prolong the ejaculatory latency time which will eventually increase the~     quality of their sexual life.~   "
29780|NCT03177213|"~     Pemphigus is severe antigen derived autoimmune bullous skin disorder, the word pemphigus is~     derived from the Greek word pemphix  which means blister . Two main clinical variants are~     known pemphigus vulgaris (PV), and pemphigu foliaceus (PF). (Zenzo .et al., 2015).~   "
29781|NCT03177200|"~     Background In view of expected growth of the older population in Singapore in the next~     decades, the volume and complexity of needs for health care services is expected to increase,~     which amplifies stress on the current healthcare system. One approach to addressing this~     challenge is to consider service utilization in relationship to needs based on population~     segmentation and to plan and evaluate new services in light of unmet needs.~      Specific Aims and Hypotheses Primary Aim 1: To establish health and social service (HASS)~     norms for population segments as defined by the Simple Segmentation Tool (SST) via a~     modified-Delphi methodology.~      Primary Aim 2: To evaluate the concordance between the types of HASS that patients in each~     population segment actually utilize versus the types of HASS normatively defined for each~     population segment over a 3-month period from the point of hospital discharge.~      Primary Hypothesis: The concordance between the actual utilization of different types of HASS~     versus normative HASS is not better than fair.~      Secondary Aim: To assess the association between concordance of normative HASS and incidence~     of adverse outcomes which includes emergency department visits, unplanned hospital~     readmissions, nursing home placement, and all-cause mortality over a 12-month period from~     point of hospital discharge for all population segments.~      Secondary Hypothesis: Patients with disagreement between normative HASS and actual~     utilization of HASS will have a higher incidence of adverse outcomes.~      Methodology The investigators will use a modified-Delphi methodology to develop HASS norms~     and conduct a follow-up study of inpatients to evaluate the concordance between the types of~     HASS utilized and norm HASS, and to evaluate the association between this concordance and~     adverse outcomes in each population segment.~      Significance to Health Services Delivery The transformation of the health care system to~     effectively meet growing needs in a patient-centric way requires practical tools for~     population planning and program development. The norms and evaluation approaches developed~     here will guide clinical and public policy decision makers in prioritizing population needs,~     and thus contribute to tangible improvements in health services delivery, patient care and~     health outcomes for an aging Singapore population.~   "
29782|NCT03177187|"~     ACE is a multi-centre proof of concept Phase I/II trial of the CXCR2 antagonist AZD5069,~     administered in combination with enzalutamide, in patients with metastatic castration~     resistant prostate cancer(mCRPC). The investigators will be investigating the safety and~     toxicity of the combination.~   "
29783|NCT03177174|"~     This study was to evaluate the efficacy ,toxic reaction and safety of different chemotherapy~     combined with radiotherapy on patients with locally advanced nasopharyngeal carcinoma.~   "
29784|NCT03177161|"~     A Patient Reported Outcome Measure (PROM) is a questionnaire that asks patients for their~     views on their own health or the impact of healthcare they have received on their health and~     quality of life (RCN, 2011). The benefit of PROMS is that they gather information from the~     patient's perspective, which offers great potential to improve the quality and outcomes of~     health services (Department of Health 2011).~      There is a PROM (the PROMIS-10 Global Health) and a number of extra questions that are~     recommended for use in people who have had a stroke by the International Consortium for~     Health Outcomes Measurement, but the best way of delivering these questions for stroke~     survivors is unknown.~      At present, the NHS in England, Scotland and Wales are required to offer every stroke~     survivors a 6 month post stroke follow-up appointment. Currently, the information collected~     at the 6 month review is not from the patient's perspective and the best method of collecting~     this information has not been established. The Sentinel Stroke National Audit Programme~     (SSNAP) which is led by the Royal College of Physicians in London promote the 6 month~     follow-up assessment. SSNAP recognise that currently 4 different methods of 6 month follow-up~     appointment occur. The current methods in use are face-to-face assessment, telephone~     interview, online questionnaire or postal questionnaire.~      The aim of this research is to understand if there is a difference between these 4 methods of~     delivering these questions in people who have had a stroke.~      As part of the 6 month review this research study will assess the response rate for 15~     Patient Reported Health Status questions across the 4 recognised methods of delivery;~        -  Face-to-Face~        -  Telephone~        -  Online~        -  Post~      To conduct this research study a sample of 808 stroke survivors will be asked to take part in~     the research. From these 808 people, 202 participants will be randomly assigned to each~     method of administration (Face-to-Face Interview, Telephone Interview, Postal Questionnaire~     and Online Questionnaire).~      The questionnaires received by the research team will not record any personally identifiable~     information. The data will then be utilised by the researchers for statistical analysis in~     order to identify, which method of the 4 methods of administration, under investigation, is~     the most acceptable for stroke survivors. The conclusions of this research will inform the~     roll-out of the most appropriate method of delivering the 6 month stroke follow-up review for~     stroke survivors.~   "
29785|NCT03177148|"~     In this cluster randomized effectiveness trial, pediatric primary care practices will be~     recruited from the American Academy of Pediatrics' national Pediatric Research in Office~     Settings (PROS) practice-based research network, as well as the client database of the~     Physician's Computer Company (PCC) - an Electronic Health Record (EHR) vendor. We will~     recruit 18 practices. 9 practices will be randomized to the Intervention arm and 9 practices~     to Usual Care. Intervention arm practices will select 1-2 pediatric clinicians to receive~     in-person training in Motivational Interviewing (MI), behavioral therapy, billing and coding,~     and study procedures. Usual Care practices will select 1-2 pediatric clinicians to receive~     billing / coding and study protocol training only, via telephone and webinar; they will be~     offered in-person MI training at the close of the trial. Around 316 parents of overweight or~     obese children (BMI > 85th percentile for age and gender) between 3 and 8 years of age at~     baseline that are patients of participating Intervention arm clinicians will be enrolled.~     Over 24 months, these parents may receive up to 4 in-person, MI-based counseling sessions~     with a trained pediatric clinician and up to 6 telephone counseling sessions with an~     MI-trained Registered Dietician (RD). There will be no study-specific contact with parents or~     their children in Usual Care practices during the trial - they will continue to receive usual~     care. EHR and billing data for all 3-8 year old children within all participating practices~     will be extracted by PCC to permit determination of the effectiveness of the intervention~     versus usual care on change in BMI z-score among 3 groups: 1) all eligible children in the~     Intervention arm), 2) all eligible children whose parent actively participates in the trial ,~     and 3) all 3-8 year old children in all participating practices.~   "
29816|NCT03176745|"~     The investigators aim to determine the optimal number of measurements required for~     multiple-breath-washout derived lung function parameters in adults with pulmonary disease as~     well as in healthy controls~   "
29817|NCT03176732|"~     Hypertension is a common consequence of obstructive sleep apnea (OSA). However, not all~     individuals with OSA have hypertension and there are major individual differences in blood~     pressure response to positive airway pressure treatment of OSA. This project is focused on~     determining the basis of these individual differences in blood pressure response to OSA and~     will evaluate the possible underlying reasons for these differences. The results will help~     clinicians to know whether or not to expect a reduction in blood pressure (BP) to OSA~     treatment in a given patient and thereby personalize patient management.~   "
29786|NCT03177135|"~     This is a Prospective study to demonstrate that the AMNIOSENSE Blue pad can reliably rule in~     or rule out amniotic fluid leak as a cause of vaginal wetness in pregnancy, thus, can be~     adopted by hospitals as an amniotic fluid leak detection tool, and can be recommended by care~     providers for use in a home usage setting.~      Study Group 1: Women attending the triage / delivery room with unidentified will be provided~     with an AMNIOSENSE Blue pad to use in hospital until they notice any wetness prior to a~     clinical assessment as per hospital standard procedure.~      The clinician performing clinical diagnosis tests for amniotic fluid leak detection,~     according to the hospital standard procedure will be at all times blinded to the results of~     the AMNIOSENSE Blue pad.~      Study Group 2: Women attending the obstetrical antenatal clinic for a routine antenatal visit~     > 36+0, and has not been referred for further assessment in triage/delivery unit by the~     physician will recruited to this study group (Study Group 2). Before leaving the antenatal~     clinic, they will be given one AMNIOSENSE Blue pad to use at home when vaginal wetness is~     experienced or in any case when they suspect that they have amniotic fluid leakage. The~     participant will be instructed to arrive at the hospital within 2 hours of applying the~     AMNIOSENSE Blue pad, regardless of the test results (positive or negative), to have a~     clinical diagnosis by the attending physician.~   "
29787|NCT03177122|"~     This is a prospective comparative randomized controlled study investigating the effect of~     Myo-Inositol-based co-treatment on oocyte quality measures in women with PCOS.~   "
29788|NCT03177109|"~     This is a single center, randomized control. Sixty eligible subjects will be recruited into 3~     study treatment groups (n=20 per group) through computerized randomization. Subjects in group~     1 will be treated with 8% arginine containing paste(Colgate® Sensitive Pro-Relief™), group 2~     with 5% topical fluoride varnish (Acclean) and group 3 with self-adhesive resin (Seal and~     protect, Dentsply). The subjects in the study will be evaluated for tactile and air-blast~     hypersensitivity criteria at baseline, two and four weeks.~   "
29789|NCT03177096|"~     The implementation of a sensor of glycemia Enlite coupled with an insulin pump (Medtronic~     Minimed 640G) is a therapeutic option that Hospital of Mulhouse can propose to the children~     affected by type 1 diabetes. The glycemic rate detected by the sensor of continuous measure~     of the glycemia is visible in real time on the pump and then the rate can be normalized. The~     study will evaluate the impact of the continuous measurement of blood glucose on insulin pump~     on child quality of life with type 1 diabetes aged 2 to 13 years old.~   "
29790|NCT03177083|"~     The primary objective of the study is to evaluate safety and tolerability as defined by the~     frequency of the adverse events (AEs) of flu-like symptoms (FLS) [chills, pyrexia, myalgia,~     and asthenia], injection site reactions (ISRs), and injection site reaction pain (ISR-P),~     over 24 weeks of treatment (the active comparator period) with PLEGRIDY 125 μg subcutaneous~     (SC) every 2 weeks versus current SC IFN-β therapy in participants with Relapsing Remitting~     Multiple Sclerosis (RRMS).~   "
29791|NCT03177070|"~     The main aim of this project is to assess whether intravenous methylene blue can help~     identify the ureters during open and laparoscopic (keyhole) surgery. The ureters are small~     tubes that link the kidney to the bladder and, if not properly identified during surgery, may~     be damaged.~      Methylene blue has been safely given to patients for many years and it is fluorescent. It is~     removed by the kidney and will therefore travel through the ureters. Methylene blue shines~     brightly (becomes fluorescent) when viewed under red light.~      This study aims to compare the ability of methylene blue with white light to identify the~     location of the ureters during colorectal surgery. Recruitment will include 50 patients~     undergoing colorectal surgery (25 for keyhole/laparoscopic, 25 for open procedures). Each~     patient will act as their own control.~      To detect the fluorescence, a special fluorescent laparoscope for keyhole surgery will be~     utilised, and a wide-field camera will be used for open surgery.~      The potential benefits of this procedure are to identify the ureters during surgery and~     therefore prevent inadvertent damage to them~      It is hoped that near infra-red light emitting from the ureters will be detected. This will~     allow the surgeon to determine the anatomy of the ureters during the operation and avoid~     inadvertent injury.~      Funding source: Nuffield Department of Surgical Sciences, University of Oxford Recruitment~     sites: Oxford University Hospitals NHS Trust.~   "
29792|NCT03177057|"~     This pilot clinical trial studies how well Self Monitoring And Readiness Texting (SMART)~     project works in sun exposure and protection behaviors. Measuring how behavior tracking and~     individually tailored messages affect risk behaviors in patients with skin cancer may help~     doctors plan the best prevention plan and decrease national melanoma incidence and mortality.~   "
29793|NCT03177044|"~     The primary aim of the project is to investigate whether a behavioural training programme~     improves troublesome bowel symptoms, that people with inflammatory bowel disease continue to~     have, despite their disease being controlled by medication. The other aim is to determine if~     there are factors which influence how well the training programme works.~      People attending an Inflammatory Bowel Disease clinic in a tertiary hospital, with bothersome~     bowel symptoms despite disease control, will be asked to join the study. This involves 2 to 6~     sessions with a pelvic floor trained physiotherapist over a period of 6 months with further~     follow up at 12 months..~   "
29794|NCT03177031|"~     This post-marketing study is undertaken to compare the clinical effectiveness and safety of~     two continuous ambulatory peritoneal dialysis produced by Fresenius Medical Care (FMC), i.e.~     Stay Safe® (STS) that is produced by a plant in Germany and Stay Safe Link® (SSL) that is~     produced in Malaysia. The study is an open labelled, randomised controlled trial where 434~     patients in total will be randomised to either STS or SSL in a 1:1 ratio.~   "
29795|NCT03177018|"~     The main objective of this study is to assess if it is possible, at the end of endocardial~     voltage mapping, to accurately collect intact cardiomyocytes and to isolate high quality DNA~     allowing molecular testing of selected genes involved in arrhythmogenic right ventricular~     cardiomyopathy/dysplasia .~   "
29831|NCT03176550|"~     Few patients recover full hand dexterity after an acquired brain injury such as stroke.~     Repetitive somatosensory electrical stimulation (SES) is a promising method to promote~     recovery of hand function. However, studies using SES have largely focused on gross motor~     function; it remains unclear if it can modulate distal hand functions such as finger~     individuation. The specific goal of this study was to monitor the effects of SES on~     individuation as well as on cortical oscillations measured using EEG, with the additional~     goal of identifying neurophysiological biomarkers.~   "
29796|NCT03177005|"~     Approval for access is solely at CSL Behring's discretion and the following criteria must be~     met for CSL Behring to consider access to experimental or unlicensed product:~        -  The patient has an unmet medical need that is life-threatening, chronic or seriously~          disabling, as defined by local regulations and applicable to the particular patient. All~          treatment options available to the patient should have been explored and exhausted by~          the physician, including participation in clinical trials.~        -  The patient and caregiver must be informed of potential risks and benefits of receiving~          the experimental therapy. The overall potential benefit should outweigh the combined~          potential risks of the experimental medicine and the outcome of the illness or disease~          itself. If approved, CSL Behring will provide treating physicians with risk information~          wording for inclusion in the physician's informed consent form, which will outline the~          risks of the experimental medicine. Treating physicians must share this information with~          the patient through the informed consent process. Treating physicians must also agree to~          participate in CSL Behring's safety monitoring and reporting requirements and follow FDA~          safety reporting regulations.~        -  Only medicines under active clinical development in the USA by CSL Behring will be~          considered for early access. There must be sufficient clinical trial data on efficacy~          and safety indicating a potential benefit greater than risks for the intended use and~          dose.~        -  Granting early access should not negatively impact or delay the ongoing development~          program with the experimental medicine to support approval by FDA and other regulatory~          authorities.~        -  Adequate supply of the experimental medicine must exist to support both ongoing clinical~          trials and approved expanded access until, and if, the product becomes commercially~          available.~      Only requests received from the licensed physician on behalf of the patient will be~     considered. CSL Behring will assess the request against the above criteria. If these criteria~     are met and the IRB/Ethics Committee and FDA approve access to the experimental therapy,~     early access may be granted. US medicine importation requirements must also be met. The~     patient's physician is responsible for the patient's ongoing care as well as all relevant US~     federal and state legislations while the patient is receiving the experimental medicine~     through early access. If approved the patient/caregiver must provide informed consent and the~     treating physician must follow safety and monitoring requirements as defined by CSL Behring.~      CSL Behring cannot provide a guarantee that expanded access will be available for every~     experimental medicine. Even if such a program is offered CSL Behring cannot guarantee that an~     experimental medicine will be available to a particular patient. The early access will cease~     if clinical trials or regulatory assessment determines the product does not demonstrate a~     positive risk benefit for patients. Once the experimental medicine is approved and~     commercially available in the US, early access will no longer be available.~   "
29797|NCT03176992|"~     Two hundred & forty patients aged from 40 to 50 years - complaining of heavy menstrual~     bleeding that is unresponsive to hormonal lines of treatment & requesting conservative~     surgical approach- were randomized into 3 groups; group A (Surgicel group) in which 80~     patients underwent formal curettage followed by insertion of 4 pieces of Surgicel inside the~     uterine cavity, group B (Thermal balloon ablation group) in which 80 patients underwent~     thermal balloon ablation using bipolar radiofrequency electrical energy (Novasure), group C~     (Endometrial resection group) in which 80 patients underwent transcervical Hysteroscopic~     endometrial resection.All patients were followed up over duration of 18 months following the~     procedure (at 3,6,12 & 18 months). Primary outcome included amenorrhea rates~   "
29798|NCT03176979|"~     This pilot clinical trial studies how well contrast enhanced spectral mammography works with~     digital breast tomosynthesis in imaging patients with newly diagnosed breast cancer. Contrast~     enhanced spectral mammography uses a special dye that is injected into the veins before~     mammogram images are taken. Digital breast tomosynthesis uses multiple x-ray pictures to~     produce a 3-dimensional rendering of the entire breast. Contrast enhanced spectral~     mammography with digital breast tomosynthesis may highlight areas of concern within the~     breast in more detail than a standard mammogram and improve the accuracy of tumor size.~   "
29799|NCT03176966|"~     The investigator's aim is to compare the efficacy of Ropinirole (Requip) to vitamin E in the~     treatment of muscle cramps in cirrhotic patients.~   "
29800|NCT03176953|"~     Alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD) frequently co-occur, and~     having both disorders is associated with greater psychological and functional impairment than~     having either disorder alone. The most effective PTSD treatment, prolonged exposure (PE) is~     sometimes less effective when individuals also have AUD. Anti-relapse medication appears~     promising to improve the effectiveness of PE to help individuals reduce alcohol use and PTSD~     symptoms and improve functioning. This study compares PE with and without topiramate, a~     medication shown to both reduce drinking and PTSD symptoms, with the hypothesis that combined~     PE and topiramate will be more effective than PE and placebo. The aim of this grant is to~     improve treatment outcomes for Veterans with AUD and PTSD.~   "
29801|NCT03176940|"~     The purpose of this study is to evaluate the administration of single doses of 2-HOBA in~     humans, with an escalation of doses that begins with the calculated Maximum Recommended~     Starting Dose. This evaluation will assess tolerability to oral administration of 2-HOBA,~     obtain pharmacokinetic data, characterize the 2-HOBA metabolic pathways, and determine the~     relation of dose to prevention of formation of bi-functional electrophile adducts in blood.~     Characterization of the metabolic fate of 2-HOBA will be supported by investigations that~     evaluate metabolism in microsomes and cells.~   "
29802|NCT03176927|"~     There is a tremendous clinical need for a noninvasive technique that can assess gastric~     electrical activity and would be repeatable without any exposure to radiation. Investigators~     developed a new technique allowing to use noninvasive methods to assess bioelectrical~     activity in the gastrointestinal system. This has enabled to characterize the normal and~     pathologic physiology of the stomach through the use of noninvasive magnetogastrogram (MGG)~     records. Primary hypothesis for this proposal is that analysis of gastric slow wave~     uncoupling and propagation in multichannel MGG discriminates between normal and pathological~     gastric electrical activity. Eventually, investigators envision this research leading to new~     insights for gastrointestinal conditions such as gastroparesis, functional dyspepsia and~     chronic idiopathic nausea that would inform clinical management of these debilitating~     diseases.~   "
29803|NCT03176914|"~     This study modified and contextualized a community mobilization approach in a bid to find a~     solution to reduce the high incidence and prevalence of child morbidity and mortality in~     Zimbabwe.The developed model will be tested for its effectiveness in reducing child morbidity~     and mortality at community level by comparing the effect of the intervention to that of the~     conventional community interventions.~   "
29804|NCT03176901|"~     The purpose of this study is to examine the feasibility of conducting a pilot randomized~     controlled trial comparing mindfulness-based stress reduction with the health enhancement~     program on symptoms of urinary urge incontinence in older adult women, and to establish~     preliminary efficacy of these two approaches on symptoms of urinary urge incontinence.~   "
29832|NCT03176537|"~     The aim of this study is to assess if hypogonadic men with periodontitis benefit from~     testosterone replacement therapy before being submitted to periodontal treatment. Fifty~     hypogonadic men (Total Testosterone <200ng/dL) will be recruited from the Clinics Hospital at~     Federal University of Paraná and subjected to periodontal evaluation by a trained and~     calibrated researcher. The subjects presenting with periodontitis (assessed by clinical~     parameters) will be randomly allocated to testosterone replacement therapy (TRT) group or~     placebo for 3 months. After that time, all patients will receive nonsurgical periodontal~     treatment, which will be reassessed after 45 days. Clinical parameters (such as probing~     depth, gingival and plaque index, clinical attachment loss, bleeding on probing), sub~     gingival plaque and gingival crevicular fluid will be collected at baseline, just before~     therapy and 45 days after therapy.~   "
29805|NCT03176888|"~     Treatment of cancer patients should not only involve removing the cancer, but should also~     focus on maintaining good health and well-being and quality of life. This can be done by~     offering patients suitable rehabilitation programmes. Previous research has shown that such~     programmes need to involve exercise alongside other components, such as psychological~     support. To date most studies have looked at the positive effects of moderate-intensity~     exercise such as brisk walking, but this type of exercise is time-consuming and often not~     done by many patients. Shorter-duration exercise routines consisting of repeated short~     sprints have been found to improve general health just as well, but one of the most~     time-efficient routines (termed 'reduced-exertion high-intensity interval training', or~     'REHIT') has not been studied in cancer patients. REHIT involves 3 exercise sessions per~     week, each only 10 minutes long. This makes it an ideal routine to combine with other~     components of a cancer rehabilitation programme. The present study will determine whether~     REHIT can improve important markers of health and well-being in newly diagnosed breast cancer~     patients. To achieve this the investigators will recruit up to 30 patients and divide them~     into a group who will do REHIT before and for up to 6 weeks after their cancer surgery, and a~     control group who will receive standard care. Markers of health and well-being will be~     measured at the start of the study, ~1 week after surgery, and ~7 weeks after surgery. Any~     changes will be compared between the exercise group and the control group. If beneficial~     effects are found with the REHIT intervention then this could be more widely implemented as~     part of cancer treatment. This study is funded by Nuffield Health and will be performed in~     Oxford, UK.~   "
29806|NCT03176875|"~     The primary objective of this study is to determine the efficacy of a novel enteral nutrition~     (EN) protocol (delivering 75% of patient's caloric needs through EN) for induction of~     remission in patients with active childhood-onset Crohn's disease (CD) and compare it to the~     standard protocol with exclusive enteral nutrition (EEN). This novel approach allows patients~     to consume remaining calories (25%) from an antiinflammatory diet for CD (AID-CD).~      The hypothesis is that no significant difference in the remission rate between the novel EN~     protocol with partial enteral nutrition (PEN) and standard protocol with EEN will be~     observed.~   "
29807|NCT03176862|"~     This study aims to understand the onset an functional consequences of left ventricular~     interstitial fibrosis in patients with chronic kidney disease (stage 2 to 5), as well as~     assess whether transplantation results in a regression of cardiac fibrosis.Thus all patients~     will undergo: 1) a cardiac magnetic resonance imaging (MRI) scan to assess cardiac function~     and measure left ventricular interstitial fibrosis; 2) a cardiopulmonary stress~     echocardiogram to understand the functional consequences of fibrosis and rule out any~     underlying ischaemic heart disease; 3) a 24 hour holter monitor and electrocardiogram (ECG)~     to assess whether these patients are at higher risk of arrhythmia.~   "
29808|NCT03176849|"~     Research has suggested that children with sufficient vitamin D levels undergoing~     hematopoietic stem cell transplant (HSCT) have improved outcomes, including lower incidences~     of infection and graft-versus-host disease (GVHD), as well as overall improved survival.~     However, supplementation in children undergoing HSCT has shown to be a challenge using~     standard or aggressive supplementation strategies. The overall objective of our study is to~     determine the effectiveness of a single, high dose oral vitamin D at the start of transplant~     followed by maintenance supplementation in children undergoing HSCT.~   "
29809|NCT03176836|"~     Li-Fraumeni Syndrome (LFS) is a cancer predisposition disorder in which most affected~     individuals develop cancer during their lifetime. The majority of LFS patients carry a~     mutation in a gene called TP53, whose normal function is to control cell growth and prevent~     cells with damaged DNA from becoming cancerous. There is currently no way to determine when,~     where or what type of tumour will develop. This project will use novel techniques utilizing~     magnetic resonance imaging (MRI) to determine how sensitive they are at detecting very small~     tumors and how specific they are in terms of distinguishing malignant tumors from benign~     tumors.~   "
29810|NCT03176823|"~     The prevention of secondary brain injury is a primary goal in treating patients with severe~     traumatic brain injury (TBI). Secondary brain injury results from tissue ischemia induced by~     increased vascular resistance in the at-risk brain tissue due to compression by traumatic~     hematomas, and development of cytotoxic and vasogenic tissue edema. While traumatic hematomas~     may be managed surgically, cytotoxic and vasogenic edema with resulting perfusion impairment~     perpetuates brain ischemia and injury. Animal models suggest that remote ischemic~     conditioning (RIC) can reverse these effects and improve perfusion. Based on these findings~     it is hypothesized that RIC will exert beneficial effects on TBI in man, thereby representing~     a new therapeutic strategy for severe TBI.~      Patients presenting to our institution suffering from severe TBI will be considered for~     enrollment. Eligible patients will have sustained a blunt, severe TBI (defined by Glasgow~     Coma Scale <8) with associated intra-cranial hematoma(s) not requiring immediate surgical~     decompression, with admission to an intensive care unit and insertion of an intra-cranial~     pressure monitor. Patients will be randomized to RIC versus sham-RIC intervention cohorts.~     RIC interventions will be performed using an automated device on the upper extremity~     delivering 20 cumulative minutes of limb ischemia in a single treatment session. The planned~     enrollment is a cohort of 40 patients.~      Outcomes of this study will include multiple domains. Our primary outcome will include serial~     assessments of validated serum biomarkers of neuronal injury and systemic inflammation.~     Secondary outcomes will include descriptions of the clinical course of each patient,~     radiologic assessment of brain perfusion, and neurocognitive and psychological assessment~     post-discharge.~      If clinical outcomes are improved using RIC, this study would support RIC as a novel~     treatment for TBI. Its advantages include safety and simplicity and, requiring no specialized~     equipment, its ability to be used in any environment including pre-hospital settings or in~     austere theatres. The investigators anticipate that TBI patients treated with RIC will have~     improved clinical, biochemical, and neuropsychological outcomes compared to standard~     treatment protocols.~   "
29811|NCT03176810|"~     The present study aims to demonstrate the superiority of optical coherence tomography~     (OCT)-guided percutaneous coronary intervention (PCI) compared with Angiography-guided PCI.~   "
29812|NCT03176797|"~     Early diagnosis and treatment of liver fibrosis can repress or delay the development of~     cirrhosis and hepatocellular carcinoma. The purpose of this pilot study is to evaluate~     non-invasive multiparametric magnetic resonance imaging (MRI) techniques in the detection and~     grading of liver fibrosis, so that patients can be treated in time. These techniques combined~     could reach high diagnostic performance for detection of liver fibrosis, and could decrease~     the number of liver biopsies.~   "
29813|NCT03176784|"~     This research will determine whether two highly promising modifications to varenicline~     treatment (i.e. use of a nicotine patch adjuvant and extended 24-week duration) produce~     superior smoking outcomes when they are either used together or alone. Despite their promise,~     the proposed modifications have never been experimentally evaluated relative to standard~     varenicline pharmacotherapy. Thus, this innovative research will produce novel evidence~     regarding how best to help smokers quit, and thereby address the leading cause of preventable~     mortality and morbidity related to cardiovascular and pulmonary diseases.~   "
29818|NCT03176719|"~     It has long been recognized that the positive effects of vaccination on childhood mortality~     cannot be solely attributed to a decline in the disease targeted by the vaccine. These~     so-called non-specific effects of vaccination have so far mostly been linked to mortality.~     However, it has been suggested that non-specific effects may also effect morbidity and~     nutritional status. This study aims to further explore the correlation between vaccination,~     susceptibility to infectious diseases (particularly malaria and bacterial infections),~     nutritional status and immunity.~      With this prospective cross sectional study among healthy individuals in rural west-Africa we~     aim to address several research questions at the same time. This study will assess the~     influence of (time-point of) vaccination on morbidity, mortality and immune status among~     healthy individuals in a rural sub-Saharan African setting. Secondly, to explore the~     prevalence of subclinical malaria, iron deficiency anemia, sickle cell anemia and thallasemia~     among a healthy rural sub-Saharan African population. And finally to assess normal~     hemocytometry values among a healthy rural sub-Saharan African population.~   "
29819|NCT03176706|"~     To avoid iodine deficiency and its consequences in pregnant women and their offspring, women~     should reach a sufficient iodine intake long before conception. To monitor iodine status,~     median urinary iodine concentration (UIC) is widely used in pregnant women (PW).~     Thyroglobulin (Tg) us another marker used to assess iodine status . In this study, urine~     samples as well as dried blood spots will be collected to measure UIC and Tg (as well as~     other hormones to define thyroid function) in PW. The results shall be used to reassess the~     threshold which defines iodine status in PW according to UIC.~   "
29820|NCT03176693|"~     Pheochromocytoma is a rare, catecholamine (ex. adrenaline) secreting tumor that requires~     preoperative alpha blockade to minimize intraoperative hemodynamic instability, thereby~     reducing intra- and postoperative morbidity and mortality. Phenoxybenzamine is a~     non-selective alpha blocker that is significantly more expensive and is associated with~     increased adverse effects in comparison with selective alpha blockers such as doxazosin.~     Retrospective studies show minimal differences in hemodynamic instability and no differences~     in postoperative morbidity and mortality between selective vs. non-selective alpha blockers.~     This study is a randomized controlled trial that will compare hemodynamic instability,~     morbidity, mortality, cost, and quality of life between patients blocked with~     phenoxybenzamine vs. doxazosin.~   "
29821|NCT03176680|"~     The goals of this study are to testify the effectiveness on enhancement recovery by new~     anesthetic ERAS (Enhanced recovery after surgery) strategy.~   "
29822|NCT03176667|"~     This study will compare ESP block plus patient-controlled analgesia (PCA) to intercostal~     nerve block plus PCA as post-operative pain control for patients having video-assisted~     thorascopic surgeries.~   "
29823|NCT03176654|"~     This study evaluates the effect of high-velocity low-amplitude thrust (HVLAT) manipulation to~     the cervical spine on neuropeptide expression as determined by the plasma concentration of~     oxytocin, neurotensin, orexin A and cortisol; and Examine the effect of HVLAT manipulation on~     pain perception in symptomatic females with non-specific mechanical cervical spine pain~   "
29824|NCT03176641|"~     This study aims to evaluate the effect of platelet-rich plasma (PRP) on meniscus injury by~     comparing the imaging and clinical outcomes between patients receiving PRP with meniscus~     repair surgery and those receiving meniscus repair surgery only.~   "
29825|NCT03176628|"~     This study will determine the pharmacokinetics, pharmacodynamics and safety of escalating~     doses of Basis following twice daily oral administration in patients with acute kidney injury~     (AKI). Basis is a commercially available nutritional supplement consisting of nicotinamide~     riboside (NR) and pterostilbene that acts to increase sirtuin activity.~   "
29826|NCT03176615|"~     The purpose of this study is to investigate harmful effects of intentional weight loss.~     Intentional weight loss has been linked to increased risk of cardiovascular disease in~     overweight individuals, but the link between intentional weight loss and thrombotic disease~     is poorly understood. Postprandial coagulation activation, including thrombin generation, is~     a potential mechanism after high-fat meals. Thirty obese patients admitted to gastric bypass~     will be included in a randomized, cross-over clinical trial. All patients will consume a~     high-fat meal and a low-fat meal served in a randomized order on two study days (two to seven~     days apart). This cross-over study will be carried out before weight loss, during~     lifestyle-induced weight loss, and during weight loss 3-4 months after gastric bypass.~     Fasting and postprandial blood samples are collected on each study days, while one fecal~     sample is collected for each study period. The study will contribute to our understanding of~     mechanisms underlying harmful effects of weight loss, and future, dietary guidelines in~     relation to intentional weight loss programs must be modified.~   "
29827|NCT03176602|"~     There are two nutrition assessment tools that are commonly used in the ICU, namely the~     Subjective Global Assessment (SGA) and Modified Nutrition Risk in Critically Ill Score~     (mNUTRIC). It has been proposed that both assessments should be performed in the ICU but~     their combined prognostic ability has not been adequately assessed.~      This study aimed to: 1) determine the agreement between SGA and mNUTRIC scores, and 2)~     quantify their utility in discriminating and quantifying hospital mortality risk both~     independently and in combination.~   "
29828|NCT03176589|"~     PEP (positive expiratory pressure) is routinely given to patients after surgery in order to~     improve lung function. There is, however, no evidence of effect on lung function,~     postoperative pneumonia or any other outcome (Guimarães MMF, Tyson AF). The investigators aim~     to test the immediate effects on oxygen saturation and carbon dioxide. 65 patients will be~     investigated in RCT design with deep inspirations and expiration using PEP or only deep~     inspiration with expiration a placebo tube without resistance air. At the end of the study we~     will also measure the effect of 10x3 very deep inspirations and no expiratory no expiratory~     resistance. Primary outcome: continuous oxygen saturation from pulse oximetry and~     transcutaneous carbon dioxide.~   "
29829|NCT03176576|"~     The purpose of this study is to develop and test a model of patient navigation that~     investigators hope will address the unique needs of adolescent and young adult (AYA) cancer~     patients and their families by minimizing barriers in their care and potentially improving~     the outcomes of their treatment while reducing distress and enhancing quality of life.~     Investigators plan to achieve this by increasing access to, and use of, the resources~     available at Moffitt Cancer Center for AYA patients and their families.~   "
29830|NCT03176563|"~     Observational follow-up study of patients included in the clinical trial REGATTA.~   "
29833|NCT03176524|"~     This is a single centre, double-blind, randomised, three-period crossover phase 1 trial in~     subjects with type 1 diabetes mellitus (T1DM). Each subject will be randomly allocated to a~     sequence of three treatments, i.e. two single subcutaneous doses of BioChaperone® Glucagon~     (BC Glucagon) formulation 1, BioChaperone® Glucagon formulation 2 and GlucaGen® HypoKit®,~     each at the fixed doses of 50 µg and 1 mg on 3 separate dosing visits.~      Following trial drug administration, pharmacokinetics (PK) and pharmacodynamics (PD)~     assessments will be carried until 4 hours. Safety will be assessed during all the trial~     period.~      The total trial maximum duration for the individual subject will be up to 10 weeks.~   "
29834|NCT03176511|"~     Poor balance is one of the major risk factors for falling in older adults. A Matter of~     Balance (MOB) is one of the most commonly used fall prevention programs nationally. Despite~     its name, MOB focuses on managing concerns about falling, and does not include a balance~     component. We are testing to see if adding a dual-task balance component (balance and mental~     thinking) to MOB can improve balance and walking better, than MOB only.~   "
29835|NCT03176498|"~     This is a randomized, double-blind study. Human umbilical cord mesenchymal stem cells~     (hUC-MSC) will be treated on cerebral infarction patients, and evaluates their neurological~     function of convalescent period.~   "
29836|NCT03176485|"~     This is a pilot study designed to evaluate the cutaneous effect of systemic inhibition of the~     tyrosine kinase pathway in the presence or absence of solar simulated light exposure.~      A maximum of 45 subjects will be accrued into the overall study we anticipate approximately~     25 patients in the Raf inhibitor group and 10 patients each into the Tyrosine Kinase and MEK~     inhibitor arms of the study.~   "
29837|NCT03176472|"~     This is a randomized, double-blind, parallel group clinical study of up to 450 patients~     designed to evaluate the safety and efficacy of ricolinostat for Diabetic Neuropathic Pain~     (DNP).~   "
29838|NCT03176459|"~     Primary objective: The primary objective of this study is to compare total opioid consumption~     through 72 hours following EXPAREL+bupivacaine HCl infiltration into the transversus~     abdominis plane (TAP) after spinal anesthesia to active bupivacaine HCl TAP infiltration~     after spinal anesthesia in subjects undergoing an elective cesarean section (C-section).~      Secondary objective: The secondary objectives are to assess efficacy and safety parameters~     and patient satisfaction.~   "
29839|NCT03176446|"~     Fear and dental anxiety are often associated with the use of needles and syringes for local~     anesthesia, and painful perception during the administration of local anesthetics is often~     the main reason for anxiety behaviors and defensive reactions. Dental trauma originates in~     childhood, through experience misconduct. The objective of this study is to evaluate the pain~     and anxiety related to 4 different modalities of anesthesia in children. Will be selected~     volunteers aged between 5 and 12 years who need restorative dental treatment in posterior~     teeth in the upper 2 quadrants. All patients will receive 1 modality of anesthesia:~     conventional anesthesia (control group), computerized anesthesia, Dental Vibe anesthesia and~     computerized anesthesia + DentalVibe anesthesia. Evaluations will be made with physiological~     and behavioral criteria. For the physiological evaluation will be measured the blood~     pressure, respiratory rate, heart rate, oximetry and salivary cortisol before and during each~     anesthesia. As criteria for evaluation of anxiety will be applied the methods, Corah and~     modified VPT before anesthesia and modified VPT will be repeated after anesthesia. The pain~     will be assessed at the end of each anesthesia with Visual Analogue Scale (VAS) and Wong~     Baker Faces. The results will be submitted to parametric and non-parametric statistical~     analysis, according to the data obtained in the different evaluation criteria.~   "
29840|NCT03176433|"~     The aim of this study is to assess the safety and feasibility of a short period of cold~     storage prior to normothermic machine perfusion in adult liver transplantation.~   "
29841|NCT03176420|"~     Ischemic stroke is the fourth leading cause of disability and mortality in the United States.~     The overall risk of emboli detachment from a chronically occluded internal carotid artery~     (COICA) is around 7% per year. Despite receiving the best available medical therapy, about 6%~     to 24% of these patients will subsequently suffer transient or permanent ischemic~     complications annually. This has been theoretically attributed to a cerebrovascular~     hemodynamic impairment.~      The management of chronic or subacute internal carotid artery (ICA) occlusions has been~     challenging clinically. Carotid endarterectomy and superficial temporal artery to middle~     cerebral artery bypass have been studied in high risk stroke patients with results showing no~     benefits in symptomatic COICA patients. Consequently, some centers have employed angioplasty~     and stenting for the management of these challenging lesions. The main concern with the~     endovascular treatment of COICA patients is the significant risk of perioperative~     complications such as distal embolization, vessel perforation, pseudoaneurysm formation,~     vessel dissection, fistula formation, and hyperperfusion syndrome. In this report, we propose~     for the first time a COICA classification, which could offer the interventionalist a guide of~     the technical feasibility and safety of endovascular recanalization of symptomatic COICA. We~     will assess the success of this classification in predicting endovascular recanalization of~     symptomatic COICA in a single -institution pilot study.~   "
29842|NCT03176407|"~     The clinical trial entitled Detection of upper gastrointestinal (GI) bleeding with a novel~     bleeding sensor capsule - a pilot study was carried out in a monocentric clinical trial with~     30 patients. This trial aimed to determine if the capsule's sensor signals allow to deduct~     the patient's bleeding status in a clinical setting.~      The target of the explorative study was to show the feasibility and safety of the HemoPill~     acute and its implementation procedure as well as, the definition of measurable parameters~     and thresholds for blood detection. Within this clinical trial, initial clinical data on the~     performance of the HemoPill acute capsule were collected.~   "
29843|NCT03176394|"~     This is a 2-week, single-site, randomized study in adults requiring short-term (≤ 14 days)~     catheterization. Subjects will be randomized 1:1 to either the biofilm disrupting gel~     (BLASTX) or SOC (McKesson Jelly) lubricated catheters. Urine and/or catheter DNA analysis~     will be obtained at catheter insertion, 2, 5, 7 and 14 days after catheterization.~   "
29856|NCT03176225|"~     The purpose of this clinical trial is to collect safety and effectiveness data to support~     cardiac repair indication of XenoSure biologic patch. This trial is performed to meet the~     China FDA regulations for this kind of device. The clinical trial will be performed solely~     inside China under GCP regulation and all applicable China regulations on medical device~     clinical trial.~   "
29844|NCT03176381|"~     This is an observational, prospective (study following participants forward in time),~     multi-center (study conducted in more than 1 center) study to identify the predictive factors~     that will effectively predict the response to abiraterone treatment in metastatic~     castration-resistant prostate cancer (mCRPC). The entire duration of study will be~     approximately 3 year. Participants will primarily be evaluated for achieving biochemical or~     radiological progression after receiving abiraterone treatment based on EAU 2017 practice~     guideline criteria. For this, we put our attentions on the FKBP5 (FK506 Binding Protein 5,~     Androgen-regulated gene), NTS (neurotensin, neuroendocrine differentiation can be induced by~     NTS) and YAP1 (yes-associated protein 1, a biomarker for cancer stem cell), which are~     selected from the data of gene-array for various subtypes of CRPC (unpublished data).~     Response to abiraterone treatment will also be predicted using other androgen-regulated genes~     like AKR1C3 and PCNA.~   "
29845|NCT03176368|"~     This study will seek to assess the experience of using of coconut oil as an approach to~     managing radiation-induced xerostomia in patients previously treated for cancer in the head~     and neck. There is a high prevalence of radiation-induced xerostomia in this patient~     population, and the condition has significant negative impact on patients' quality of life.~     There is currently no agreed-upon standard of care for the treatment of this condition.~     Anecdotal evidence from patients and both physicians and allied healthcare providers suggests~     improvement in this condition with the use of coconut oil, but this has not previously been~     formally studied. We therefore propose a case series study to formally assess the~     tolerability and efficacy of coconut oil as an approach to managing radiation-induced~     xerostomia.~   "
29846|NCT03176355|"~     30 patients had lacrimal sac mucocele and dacryocystorhinostomy was done for them with~     intraoperative mitomycin C was added to decrease postoperative fibrosis and recurrence.~   "
29847|NCT03176342|"~     The study is about drug patch tests in patients who have history of severe cutaneous drug~     reaction including Steven Johnson syndrome (SJS), toxic epidermal necrolysis (TEN),~     Drug-induced eosinophilia and systemic symptoms (DRESS), AGEP (Acute generalized~     exanthematous pustulosis) and generalized bullous fixed drug eruptions. This study also~     investigate in Enzyme-linked immunosorbent spot assay (ELIspot) and lymphocyte transformation~     test. We also trying to prove the correlation among result of drug patch tests, ELIspot and~     LTT.~   "
29848|NCT03176329|"~     Nursing is essential in critically ill patients care but with high risk of hypoxia,~     especially during mobilization. Full closed-loop control ventilation is well established for~     her safety in unselected ventilated critical care patients with different lung conditions~     compared to conventional ventilation.~      The aim of this study is to assess the ability of a full closed-loop control ventilation~     (Intellivent-ASV, TM) to reduce hypoxia during mobilization period in unselected ventilated~     patients.~   "
29849|NCT03176316|"~     Postoperative ileus and opioid induced constipation are well-known post-operative~     complications. Previously, research has shown that using peripherally acting opioid~     antagonists can help alleviate the condition. There has not been a prospective study to~     investigate whether use of peripherally acting opioid antagonists are effective in preventing~     post-operative ileus in patients having spinal fusion surgeries.~   "
29850|NCT03176303|"~     This study examines the effect of adjunctive use of the SpinalStim bone growth stimulator on~     lumbar fusion rate in high risk subjects who have had lumbar fusion surgery. All participants~     will wear the bone growth stimulator for a minimum of 2 hours/day for 6 months.~   "
29851|NCT03176290|"~     The aim of this study is to compare prospectively the ability of MRE and Transient~     Elastography in detection and staging of allograft fibrosis in comparison to Liver biopsy in~     patients who underwent Living Donor Liver Transplantation for complications related to HCV.~   "
29852|NCT03176277|"~     This study will determine the safety and maximum tolerated dose of ONO-7475 in patients with~     relapsed or refractory acute leukemia and evaluate the efficacy of ONO-7475 in patients with~     newly diagnosed AML~   "
29853|NCT03176264|"~     This is a phase Ib study of PDR001 in combination with bevacizumab and mFOLFOX6 as first line~     therapy in patients with metastatic microsatellite stable (MSS) colorectal cancer. The study~     will assess primarily the safety and tolerability and then the efficacy of PDR001 in~     combination with bevacizumab and mFOLFOX6. Particular attention will be paid to the level of~     activity of study drug combinations in CMS4 patients (retrospective analysis).~   "
29854|NCT03176251|"~     Simulation-based training curricula for gastrointestinal endoscopy have been developed and~     have been shown to be effective. It is possible that these curricula may be further improved.~     Gamification, the application of game-design principles to non-game contexts, has been shown~     to improve learning and skill performance in medical education. In gastrointestinal~     endoscopy, however, no dedicated curricula have been developed using gamification principles.~     We aim to evaluate the impact of applying gamification to a curriculum using SBT in endoscopy~     on clinical performance, compared to an identical curriculum without gamification. 36 novice~     endoscopists from the general surgery and gastroenterology programs at the University of~     Toronto will be recruited. Participants will be randomized into two groups: the Conventional~     Training Curriculum (CTC) Group, in which participants will receive 6 hours of training on a~     simulator augmented with expert feedback and interlaced with 4 hours of didactic training on~     the theory of colonoscopy; and the Gamified Integrated Curriculum (GIC) Group, in which~     participants will receive the same curriculum, using the following applications of gamified~     learning: a leaderboard of participant performances; badges for achievement of training~     landmarks; and rewards for top performance. Participants will be trained to perform~     colonoscopies progressively moving from a low to high complexity simulators, starting with~     the bench-top model (1 hour) and then moving to the EndoVR® virtual reality (VR)~     gastroenterology simulator (5 hours). Performance will be assessed at three points: prior to~     training (pre-test), immediately after training (acquisition post-test) and 4-6 weeks after~     training (retention test). Assessment will take place on the simulator at all three time~     points and during two live colonoscopies at the retention test. The primary outcome measure~     will be the difference in clinical colonoscopy performance between the two training groups,~     as assessed by the Joint Advisory Group for GI Endoscopy Direct Observation of Procedural~     Skills (JAG/DOPS). We aim to have data collection finished by 2018. Our results have the~     potential to improve existing curricula for training in colonoscopy. Moreover, the~     development of a gamified curriculum in procedural skills may have applicability to other~     specialities, such as general surgery and anesthesiology.~   "
29855|NCT03176238|"~     The present international, multi-center, open-label, single-arm study aims at collecting~     clinical safety, tolerability and efficacy data with the use of everolimus combined with~     exemestane in the Novartis Oncology Emerging Growth Market (EGM) countries for the treatment~     of post-menopausal women with hormone receptor (HR) positive, human epidermal growth factor~     receptor 2 (HER2) negative locally advanced or metastatic breast cancer after documented~     recurrence or progression following a non-steroidal aromatase inhibitor (NSAI) therapy.~   "
29894|NCT03175731|"~     This study is aimed at investigating the effect of PPIs on esophageal variceal bleeding in~     cirrhotic patients. Half of participants will receive PPI, while the other half will receive~     a placebo.~   "
29857|NCT03176212|"~     This study was designed to determine if an ingredient in milk fat can prevent gut leakiness~     induced by running at 80% maximum oxygen consumption (VO2max). In mouse studies, the milk fat~     ingredient, and individual components thereof, have been shown to reduce gut leakiness~     induced by intra peritoneal lipopolysaccharide (LPS) injections.~      The investigators hypothesis is as follows: Compared to a sports drink with identical macro~     nutrient composition, a sports drink with milk fat globule membrane (MFGM) will reduce the~     change in gut leakiness induced by running at 90% VO2max for 30 minutes. The decrease in gut~     permeability change will be associated with a decreased area under the curve of plasma~     endotoxin for 5 hours following the exercise. In addition, decreased gut permeability will be~     associated with lower area under the curve values for inflammatory cytokines.~   "
29858|NCT03176199|"~     This study is to evaluate the efficacy and safety of a titration method by selects 10 mg~     control-released (CR) oxycodone tablet as background drug in combined with immediate-released~     (IR) oxycodone, compared to conventional titration method with immediate-released (IR)~     oxycodone in patients with moderate to severe cancer pain in Taiwan.~   "
29859|NCT03176186|"~     XePOHCAS: Prospective, randomized, multicenter interventional trial in adult subjects with~     out-of-hospital cardiac arrest comparing treatment with standard-of-care post-cardiac arrest~     intensive care (which is targeted temperature management [TTM]) to xenon by inhalation plus~     standard-of-care post-cardiac arrest intensive care (including TTM).~   "
29860|NCT03176173|"~     This phase II trial studies how well radical-dose image guided radiation therapy works in~     treating patients with non-small cell lung cancer that has spread to other places in the body~     who are undergoing immunotherapy. Radiation therapy uses high energy x-rays to kill tumor~     cells and shrink tumors. Giving radical-dose image guided radiation therapy to patients with~     non-small cell lung cancer may help to improve response to immunotherapy anti-cancer~     treatment.~   "
29861|NCT03176160|"~     The purpose of this study is to to describe the effect of a palliative regimen consisting of~     Laser Interstitial Thermal Therapy (LITT) on distress, quality of life (QOL), neurocognition,~     days in the hospital, patient disposition, and readmission in newly diagnosed World Health~     Organization (WHO) grade IV malignant glioma (glioblastoma (GBM) or gliosarcoma) patients~     unable to undergo broader surgical resection. The primary objective is to assess changes in~     the National Comprehensive Cancer Network (NCCN) distress thermometer in newly diagnosed WHO~     grade IV malignant glioma patients who receive LITT.~      *Please note: This study was originally designed as a interventional device study studying~     the effect of the LITT procedure; however, it was re-designed as an observational study in~     which the patient population being studied is approved to receive the LITT procedure.~   "
29862|NCT03176147|"~     Iron deficiency anemia is the leading cause of anemia during pregnancy, which can still reach~     10 to 20% of pregnant women in developed countries, with potentially serious consequences for~     the child. Systematic iron supplementation remains controversial.~      This study aims to identify in the first trimester of pregnancy clinical and biological~     predictive factors for the occurrence of iron deficiency anemia in the third trimester of~     pregnancy.~   "
29863|NCT03176134|"~     This study will evaluate the safety, tolerability, and efficacy of tedizolid phosphate~     (MK-1986) compared with comparator antibacterial agent in participants from birth to <12~     years of age with acute bacterial skin and skin structure infections.~   "
29864|NCT03176121|"~     This study is to evaluate the safety and tolerability of oxycodone control-released (CR)~     and/or immediate-released (IR) use in patients with moderate to severe cancer pain in a~     3-months period in Taiwan.~   "
29865|NCT03176108|"~     Attention Deficit Disorder (ADD) with or without Hyperactivity/Impulsivity (ADHD) is a~     neurodevelopmental syndrome that has a lasting impact on the child's daily lifestyle and~     leads to functional impairment. ADHD is recognized as the most common psychiatry disorder in~     children and it's considered as a public health problem.~      ADHD is frequently associated with a new diagnostic entity  Disruptive Disorder with~     Emotional dysregulation . This disorder is characterized by crisis of anger with verbal or~     physical aggression, intensity disproportionate to the context and developmental age.~      Few studies have examined the elements of emotional dysregulation in ADHD in children. Many~     studies have shown the interest of CBT in multimodal management of ADHD symptoms and~     associated disorders.~      The main objective is to evaluate the effectiveness of a Cognitive-Behavioral Therapy~     Parent/Child program versus a body mediation focused on emotional and behaviorial aspects in~     ADD children aged 7-13 years with dimensional emotional dysregulation at 6 months after~     intervention. Secondary objectives are to evaluate the impact of this program, at short-term~     (at the end of CBT) and at 6 months after intervention, on socio-communicative capacities,~     quality of life, children's functioning and parental stress.~      It's a biomedical research, prospective, controlled, randomized, monocentric, two parallels,~     with an evaluation of the criteria of blind judgment.~   "
29866|NCT03176095|"~     Background/Aim: Celiac disease is a common immune-mediated disorder, and the only currently~     available treatment is a gluten-free diet. Recent studies have shown several probiotics to~     carry properties that might positively influence the immunological activity in celiac~     patients.~      The aim of the present study is to investigate how daily consumption of probiotics would~     affect levels of tissue transglutaminase autoantibodies (tTGA), markers of celiac disease~     autoimmunity in the periphery, as compared to placebo in children at genetic risk for celiac~     disease.~      Methods: Between 2012 and 2015, 90 children were recruited from two ongoing prospective~     celiac disease screening studies at the Skåne University Hospital, Sweden. Participants were~     randomized to either daily consumption of 2 lactobacilli strains or placebo for the duration~     of 6 months.~      Blood samples were drawn at 0, 3 and 6 months and analyzed for both IgA-tTGA and IgG-tTGA~     using radioligand binding assays.~   "
29867|NCT03176082|"~     Purpose: The investigators propose to test the effectiveness, feasibility, and~     cost-effectiveness of a mailed reminder with and without FIT kits in a population of Medicaid~     enrollees in Mecklenburg County.~   "
29907|NCT03175562|"~     The objective of this clinical study is to assess the irritation and sensitisation potential~     of a cosmetic test product after repeated semi-occlusive patch applications to healthy human~     participants by following a conventional HRIPT methodology under supervision of a~     dermatologist.~   "
29868|NCT03176069|"~     Sexuality is considered one of the pillars of quality of life, an integral part of the~     personality of each individual. Being a basic human being need, it cannot be separated from~     other aspects of life. For several centuries and until recently, sexuality was considered the~     lower instincts expression related only to the sexual act. Sex is associated with~     reproduction of the sexual energy. On the other hand, the exercise of sexuality includes~     various factors such as the building of the sensitivity between individuals like touch,~     dance, fantasy, look, etc. For a long time feminine sexuality was predominantly focused on~     procreation and has only recently been considered as an integral part of sexual and~     reproductive rights of women. Vaginismus is a female sexual dysfunction that affects the~     quality of sexual and psychosocial lives of women, influencing the quality of the couple's~     relationship. The scientific literature emphasizes the importance of the examination,~     diagnosis and physical therapy for this dysfunction, but until now there is no quantification~     or evaluation of the pelvic floor muscles for this group of women, which justifies the~     realization of this project.~   "
29869|NCT03176056|"~     This study determines whether an educational intervention with a 90 g/day LCD is safe,~     effective and has good compliance for poorly controlled type 2 diabetes patients.~   "
29870|NCT03176043|"~     The purpose of the study is to determine whether participants who are dictating their own~     administration of IV fluid boluses in response to thirst, receive better protection from~     hypovolaemia and volume overload than those who undergo routine fluid management.~      Thirst is prominent in critically ill patients and is related to dehydration. In a recent~     study of the symptoms experience in ITU patients at high risk of dying, the sensation of~     thirst was reported in 70.8% of assessments made and was considered to be one of the most~     intense stressors. Thirst and dehydration can be combated in an ITU setting by consuming oral~     fluids and through administration of intravenous fluids. However, in older adults, frailty~     and dysphagia reduces patients' capability to access fluid and results in thirst. In~     addition, the administration of IV fluids is determined by the attending physician and is~     often only re-evaluated on a daily or twice-daily basis.~      The Quench machine has been designed to allow the patient to have more control over their~     oral and IV fluid administration protocol. This may help reduce the sensation of thirst and~     dehydration in patients. The machinery is an automated fluid delivery system that will~     administer a given bolus of IV fluid in response to a trigger provided by the patient.~      The purpose of the current study is to examine the physiological basis for the functional~     benefit of this Quench system by investigating the effectiveness of the thirst response in~     healthy humans as a guide for administration of intravenous fluid boluses.~      To explore this, the investigators have designed a randomised, cross-over study. On one visit~     IV fluid boluses will be administered as per the participants' request in response to thirst.~     In the second arm of the study participants will be administered routine IV fluid maintenance~     as per NICE guidelines. Body mass at the end of a 4 hour fluid administration intervention~     will be our primary research outcome and will be compared between the two arms of the study.~      From this comparison the investigators hope to show that a patient would be able to~     accurately manage their level of hydration, both in terms of correcting dehydration and~     avoiding fluid overload. It is thought that avoiding states of fluid imbalance can reduce~     post surgical recovery times, reduce the incidence of post operative complications and avoid~     critical complications of fluid imbalance, such as acute kidney injury.~   "
29871|NCT03176030|"~     Malnutrition in older inpatients is a significant problem espicially among those with~     dementia. A number of methods have been used to tackle this issue and oral nutritional~     supplements (ONS) were proven to be the most effective way. However, they are limited by~     their poor tolerability due to lack of familiarity with these products. An alternative method~     is to fortify familiar food with protein, energy and micronutrient. thus, the aim of this~     study to test the feasibility and acceptability of delivering fortified foods to older~     patients whilst in hospital including those with dementia and frailty. This pilot study will~     compare the daily protein and energy intake in older people before and after offering~     fortified food. Furthermore, patients' likeability and staff acceptability of these fortified~     foods will be assessed.~   "
29872|NCT03176017|"~     In this study, Investigators planned to compare Holmium Laser ejaculatory sparing and~     non-ejaculatory sparing (conventional) TUIP using both subjective and objective assessment~     tools for the degree of deobstruction.~      Furthermore, the impact of both techniques on ejaculation and its secondary effect on orgasm~     perception and different domains of sexual function will be thoroughly assessed.~   "
29873|NCT03176004|"~     This is a multi-site study to examine error-related brain activity (i.e., the error-related~     negativity) and anxiety symptoms in 11 to 14 year-olds (N=600) at two time points separated~     by two years. The study examines the degree to which error-related negativity can predict~     anxiety prospectively over two years, and whether a computerized game that alters attention~     to threat can alter error-related negativity and trajectories of anxiety.~   "
29874|NCT03175991|"~     Ovarian masses are common problems in clinical practice. Sonography is considered the~     firstline imaging technique for discriminating between malignant and benign lesions, and it~     has been shown to be useful for determining optimal treatment.~   "
29875|NCT03175978|"~     The primary objective of this study is to determine the safety and tolerability of utilizing~     the insulin-like growth factor-1-methotrexate conjugate, 765IGF-MTX for the treatment of~     advanced, previously treated myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia~     (CMML) and oligoblastic acute myelogenous leukemia (oligoblastic AML or O-AML), including~     determining the maximum tolerated dose (MTD).~   "
29876|NCT03175965|"~     This study aims to examine whether P30 wave of somatosensory evoked potentials (SEP) is~     related with outcome after cardiac arrest. The study design is a prospective,~     multicenter-observational study. Patients survived after out-of-hospital cardiac arrest~     undergoing hypothermic-targeted temperature management will participate in the study.~     Relationship of P30 wave of SEP with the neurologic outcome on hospital discharge will be~     evaluated.~   "
29877|NCT03175952|"~     The study is a prospective cohort study conducted in Tianjin Chest Hospital, China. Patients~     with saphenous vein graft disease after coronary artery bypass graft, and planning for~     receiving percutaneous coronary intervention after virtual histology intravascular ultrasound~     will be enrolled between May 2017 and April 2019. These subjects will be followed up at 1, 6~     and 12 months post-operation of PCI to assess the short-term and long-term effect.~   "
29878|NCT03175939|"~     This study evaluates whether some patients with nasopharyngeal carcinoma but with low risk of~     distant metastasis can be treated with only radiotherapy and concomitant chemotherapy but~     without additional adjuvant chemotherapy.~   "
29879|NCT03175926|"~     Asthma is a major public health problem. The main treatments against asthma are delivered to~     the lung through several dry-powder inhaler such as Turbuhaler ®, Diskus® and the new~     Ellipta® device. In real life, patient's ability to handle a device is not routinely assessed~     by their practitioner. We hypothesized that many asthmatics cannot properly prepare and prime~     their device, which may alter the positive effects observed in clinical trials.~   "
29880|NCT03175913|"~     This was a single-blind, randomized controlled trial. Sixty-six patients who underwent caudal~     epidural injection were randomized into the vapocoolant spray group or local infiltration~     group. Before the insertion of a 20-gauge spinal needle, the subcutaneous tissue was~     infiltrated with 3 ml of 2% lidocaine in the local infiltration group and vapocoolant spray~     was applied just before the spinal needle insertion in the spray group. 100-mm visual analog~     scale to evaluate the pain intensity of spinal needle insertion and a five-point Likert scale~     for patient satisfaction and preference for repeated use were compared between the two~     groups.~   "
29881|NCT03175900|"~     This is a randomized, double-blind, placebo-controlled clinical trial. Its main purpose is to~     investigate the effects and neural mechanism of Naoan dripping pills on migraine patients by~     utilizing fMRI and DTI method, as well as headache evaluation measures such as responder~     rate, headache duration, PRO scale, etc.~   "
29882|NCT03175887|"~     This study is aimed to help us learn about the effects of Transcranial Magnetic Stimulation~     at the forehead versus the left side of the head for treatment of Treatment Resistant~     Depression.~   "
29883|NCT03175874|"~     Autophagy is recognized as a central mechanism for the regulation of aging. . Osteoporosis~     (OA) and Alzheimer's disease (AD) are two forms of pathological aging, sometimes entangled,~     including an over-risk of OP in AD and degradation of cognitive functions after OP fracture,~     but the link between These two pathologies remain poorly understood.~      The aim of this prospective pilot study is to evaluate the level of autophagy of osteocytes~     (OST) in postmenopausal women with OP and to explore the hypothesis that the defect of~     autophagy is one of the physiopathological links of the OP During the MA~   "
29884|NCT03175861|"~     Identify 18-Fluorodeoxyglucose (18F-FDG) positron emission tomography-computed tomography~     (PET-CT) parameters predictive of tumor response and local control~   "
29885|NCT03175848|"~     This is a prospective, single arm, phase II trail to assess the effect of primary lesion~     radiotherapy in the treatment of stage IVB cervical cancer on the basis of systemic~     chemotherapy.~   "
29886|NCT03175835|"~     The purpose of this study is to evaluate the drug interaction between CKD-519 and~     rosuvastatin in healthy male subjects.~   "
29887|NCT03175822|"~     The purpose of the proposed study is to better understand what benefits visual art has on~     reducing problematic symptoms in dementia patients, including those with Alzheimer's disease.~   "
29888|NCT03175809|"~     The presence of trigger points in the pelvic floor musculature (PFM) is a frequent condition~     in individuals with chronic pelvic pain (CPP) and is associated with higher levels of pain,~     disability and functional decline. The purpose of this study is to test the effectiveness of~     two interventions: pelvic floor muscle (PFM) training with biofeedback and PFM training with~     the addition of trigger point dry needling applied over(Lumbar square, psoas, external~     obliques, gluteus medius, piriformis and adductors) on pain and quality of life of women with~     CPP.~   "
29889|NCT03175796|"~     The primary objective is to rigorously evaluate the effectiveness of the Infant Mental Health~     Home Visiting (IMH-HV) model on maternal and child outcomes according to legislative~     standards via a randomized controlled trial. The research team will recruit caregivers and~     their children (0-24 months) or pregnant women (n=72) from locations across Washtenaw County~     to participate in the IMH-HV RCT. Half of the women will be randomly assigned to a treatment~     as usual (TAU) control group (with access to all available community resources), and half of~     the women will be randomly assigned to the treatment group (i.e., IMH-HV). Women assigned to~     the control group will not receive IMH-HV treatment through the study team, but will not be~     prohibited from seeking or accessing IMH-HV treatment or any other services through community~     resources. Women assigned to the treatment group will receive IMH-HV treatment for 12 months~     through the study team with rigorous monitoring of fidelity to the IMH-HV model. All study~     participants will undergo assessments across the 12-month period of the treatment trial~     (i.e., baseline (randomization will occur after baseline), mid-points (3, 6 and 9 months) and~     follow-up (12 months) after randomization).~      The purpose of this study is to evaluate efficacy of the Infant Mental Health Home-Visiting~     (IMH-HV) model on parental and child outcomes according to legislative standards and~     consistent with the State of Michigan's benchmarks. If this study confirms the efficacy of~     the IMH-HV model, this will support the sustainability of IMH-HV in the state of Michigan as~     evidence from a randomized controlled trial is necessary in order to access certain state and~     federal dollars. Access to evidence-based and sustainable parenting support can ultimately~     improve outcomes for this vulnerable population. Specifically this study aims to:~        1. Conduct a randomized controlled trial to evaluate the efficacy of IMH-HV treatment~          utilizing rigorous outcomes monitoring and evaluation methodology to establish that the~          families served achieve the intended positive benefit. Eligible caregivers and children~          or pregnant women will be assigned to the control group or the treatment group and both~          groups will receive research assessments at regular intervals measuring key impacts of~          the IMH-HV model.~        2. Determine IMH-HV efficacy via analysis of treatment impact on key caregiver, child, and~          family indicators. The hypothesis is that there will be positive impacts of IMH-HV, with~          caregiver, child, and family-level improvements from baseline to post assessment on key~          indicators, including:~             1. Improved child outcomes as reflected in strengthened child physical and behavioral~               health, development and school readiness, and reduced risk for child maltreatment.~             2. Improved parental outcomes including improved parent mental health, decreased child~               abuse potential, and enhanced positive parenting.~             3. Improved family environment including decrease in crime and family violence,~               enhance linkage to referrals and improve family economics and self-sufficiency.~        3. Identify factors associated with family improvement, including dosage and fidelity of~          treatment. It is the hypothesis that a dose-response association between the number of~          home visiting sessions and treatment impact, and a positive association between fidelity~          of treatment delivered and positive child and family outcomes.~   "
29890|NCT03175783|"~     Early mobilization is an important element in Enhanced Recovery After Surgery (ERAS). It~     reduces risk of conditions which are related to prolonged bed rest such as deep vein~     thrombosis, lung atelectasis, pneumonia, and sacral sore. (Appelboom, Taylor et al. 2015) It~     is also associated with shortened length of hospital stay, improved survival, and reduction~     in health care cost.~      However, early mobilization was not defined consistently in previous study. Some authors~     recommend patients to get out of bed and ambulate on the day of operation while others define~     as getting out of bed more than 2 hours on day of operation and up to 8 hours on second~     post-operative day. (Wolk, Meissner et al. 2017) The inconsistency in definition is partly~     due to the inability to quantify patients' mobility which is usually self-reported by~     patients and is subjective.(Eva van der Meij 2017) This is especially true for elderly~     patient in whom preoperative mobility varies significantly between individuals. For this~     reason, the approach of early mobilization in elderly should be goal directed and~     individualized according to their preoperative mobility and functional status.~      The aim of current study is to monitor and motivate elderly patients undergoing abdominal~     surgery to increase postoperative mobilization by using Fitbit Zip activity tracker.~   "
29891|NCT03175770|"~     In the last years radiofrequency resection has become a frequent method in surgical~     subspecialties. Although many departments are using this method for the resection of Tumor in~     the oropharynx, there is no study so far which describes feasibility and safety.~      Goal of this study is to show feasibility and safety of Radiofrequency Resection in~     Oropharyngeal Tumor Surgery.~   "
29892|NCT03175757|"~     The purpose of this study is to assess the effects of a turmeric and black cumin seed~     formulation on cholesterol levels.~   "
29893|NCT03175744|"~     The purpose is to demonstrate the safety and effectiveness of the Stellarex DCB for the~     treatment of stenosis or occlusions of below-the-knee arteries.~   "
29895|NCT03175718|"~     Project Summary - Aggressive soft tissue cancers are commonly treated with radiation followed~     by surgery. These wounds have a very high rate of wound complications and infection (30%),~     resulting in more surgeries, longer hospital stays and complex nursing care. Previous~     research shows that negative pressure (vacuum) dressings applied to the incision at the end~     of surgery can reduce these complications. The Investigator and his team across Canada will~     perform a clinical trial comparing standard dressings to these vacuum dressings. The results~     of this study have the potential to immediately improve the quality of life of soft tissue~     cancer patients. It can also decrease the amount of time required in hospital and reduce the~     cost to the Canadian healthcare system.~   "
29896|NCT03175705|"~     This study enrolls patients who have relapsed/advanced hepatocellular carcinoma (HCC, BCLC~     stage C). The HCC tumor relapsed or metastasized through the body after standard treatment or~     the patients cannot receive standard treatment under current conditions. This research study~     uses specific HCC antigens CD8+ T cells, a new experimental treatment.~      The purpose of this study is to evaluate the safety and tolerance as well as the potential~     clinical efficacy of an adoptive transfer of CD8+ T cells, sorted with human leukocyte~     antigen (HLA)-peptide multimers and specific for Glypican (GPC)-3 /New York Esophageal~     Squamous-1 (NY-ESO-1) /alpha-fetoprotein (AFP) antigens and cultured in vitro, to patients~     suffering from relapsed/advanced hepatocellular carcinoma (HCC).~   "
29897|NCT03175692|"~     Under the joint efforts of genetic and intensive expert, to establish the high-throughput~     whole exon sequencing(WES) and analysis all the possible pathogenic genes. To provide patient~     with the appropriate treatment for genetic disease. Besides, it can identify the genetic~     factor of idiosyncrasy or susceptibility to explain the medical difficulties and give~     patients personalized advice.~   "
29898|NCT03175679|"~     This study enrolls patients who have relapsed/advanced hepatocellular carcinoma (HCC, BCLC~     stage C). The HCC tumor relapsed or metastasized through the body after standard treatment or~     the patients cannot receive standard treatment under current conditions. This research study~     uses special immune system cells called iNKT cells, a new experimental treatment.~      The purpose of this study is to find the biggest dose of iNKT cells that is safe and~     tolerance, to see how long they last in the body, to learn the immunoresponse in the body, to~     learn the side effects are and to see if the iNKT cells will help people with~     relapsed/advanced hepatocellular carcinoma (HCC).~   "
29899|NCT03175666|"~     This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination~     therapy in subjects with metastatic or unresectable TNBC who have progressed on or after~     anthracycline-based chemotherapy or who have refused anthracycline-based chemotherapy.~   "
29900|NCT03175653|"~     The purpose of this randomized trial is to examine whether the number of opioid pills~     prescribed for pain control after Cesarean section has an effect on patient reported pain~     levels and satisfaction with pain control during recovery. Both groups receive what is~     considered an adequate number of pills for pain control after an uncomplicated Cesarean~     delivery. Secondarily, the investigators wish to gather reliable information about the~     duration of use of opioids for pain control after uncomplicated Cesarean section, and what~     happens to unused medication.~      After an uncomplicated Cesarean section, patients will be approached and asked to participate~     in the study. If the patient agrees, she will be randomly assigned to one of the two study~     groups and receive a prescription for opioid medication at the time of hospital discharge. At~     her standard care follow-up visit 10-14 days later, the participant will complete a survey~     asking questions about her pain levels during recovery, her use of study-related and~     non-study-related pain medication, and satisfaction with pain control. At that point the~     patient's participation in the study will end.~   "
29901|NCT03175640|"~     The U.S. is in the midst of an epidemic of opioid overdose deaths. The common use of opioids~     among persons living with HIV, along with their common use of benzodiazepines, has resulted~     in high rates of opioid overdose among this population. This study will test the~     implementation of evidence-based training, mentoring, technical support, and academic~     detailing to encourage HIV physicians to adopt evidence-based interventions to reduce~     overdose risk and treat opioid addiction.~   "
29902|NCT03175627|"~     The purpose of this study is to determine whether a new tooth-colored composite material is~     effective for load-bearing dental fillings.~   "
29903|NCT03175614|"~     This is a randomized clinical trial aimed at obese and sedentary subjects aged 20 to 65 years~     selected in urban primary care centers of 5 centers (Spain). Its objective is to evaluate the~     effects of the addition of an ICT tool developed for the Smartphone application and a~     Smartband in support of behavioral and educational recommendations to reduce weight.~   "
29904|NCT03175601|"~     The general objective of this study is to identify biomarkers of sleep quality, sarcopenia,~     insulin resistance, oxidative stress and inflammation associated with prefrailty in~     middle-aged and elderly obese subjects through the integrated study of sleep patterns,~     functional cardiovascular testing, olfactory function and circulating molecules.~      Results from the SleSOB study will contribute to identify molecular and functional~     determinants of prefrailty, to allow early targeted interventions and will have important~     implications for empowerment of elderly citizens to self-management of preventive measures~     and healthy lifestyle.~   "
29905|NCT03175588|"~     The aim of this study is to assess the effectiveness of interactive video-games on mobility~     and wellbeing and to compare them with activity-based approaches in geriatric population.~      100 people living in Bahcelievler nursing home will be evaluated and volunteers who meet the~     criteria will be included in the study. Persons will be placed in the study groups in~     consideration of their interests. One group will be included in Nintendo Wii program with~     balance board, which is the most frequently preferred game consoles in rehabilitation, and~     video-games will run for 30 minutes two days a week for 8 weeks. The other group will~     participate a program consisting of various physical activities for the same duration; The~     results of both groups will be compared with a control group.~   "
29906|NCT03175575|"~     The pilot study aims to investigate the place of fresh garden produce in the food supply and~     food practices of women in community gardens of deprived neighborhoods of Marseille, reputed~     to be among the poorest in the European Union. We hypothesized that access to a community~     garden in these neighborhoods could help instigate the adoption of healthier food patterns by~     gardeners and their households, and in particular, increase their consumption of fruits and~     vegetables.~   "
29909|NCT03175536|"~     Asthma is one of the most common chronic diseases in the U.S. Despite guidelines, adherence~     to recommended controller medications is low. Cost is an important barrier to adherence.~     Employers are increasingly adopting high-deductible health plans (HDHPs) which require~     deductibles of > $1,000 per individual/$2,000 per family each year. In HDHPs with Health~     Savings Accounts (HSAs), most medications and non-preventive care must be paid out-of-pocket~     (OOP) until the deductible is reached. The lower premiums of HSA-HDHPs are appealing, but the~     high level of OOP costs can lead patients to forgo needed care. HSA-HDHPs can exempt~     preventive care from the deductible, and employers can add Preventive Drug Lists (PDLs) which~     exempt certain chronic medications from the deductible (including asthma medications), making~     them free. PDLs have the potential to improve controller medication use, which could prevent~     negative health outcomes and reduce cost-related trade-offs for families.~      The goal of this research is to evaluate the impact of these two developments in the health~     insurance market -- HSA-HDHPs and PDLs -- on medication use and clinical outcomes for adults~     and children with asthma. To do this, tteh investigators will first conduct in-depth~     interviews with patients with asthma and parents of children with asthma who have HDHPs and~     traditional plans. Interviews will collect patient-reported data on how patients and their~     families navigate their insurance plan and make health care decisions when faced with OOP~     costs. Findings from the interviews will inform analyses of data from a large national health~     plan from 2004-2017. Investigators will select adults and children with asthma whose employer~     switched them from traditional plans to HSA-HDHPs with or without a PDL. Analyses will~     examine changes in asthma medication use, emergency department (ED) visits, hospitalizations,~     and OOP costs before and after changing plans compared to similar patients who did not switch~     to a HSA-HDHP. The study aims to: 1) understand health care decision making and experiences~     of families with asthma with HDHPs; 2) examine the impact of HSA-HDHPs with and without PDLs~     on use of asthma medications and asthma-related ED visits and hospitalizations; 3) examine~     the extent to which the response to HSA-HDHPs and PDLs is affected by the presence of other~     family members with asthma or other chronic conditions; 4) examine the impact of HSA-HDHPs~     with and without PDLs on OOP costs for families.~   "
29910|NCT03175523|"~     The objective of this trial is to compare clinical outcomes between imaging-guided and~     QCA-guided strategy in patients with native coronary artery disease undergoing BRS~     implantation.~   "
29911|NCT03175510|"~     This study, we performed the Turkish version validity and reliability of the Back Pain~     Function Scale.~   "
29912|NCT03175497|"~     The purpose of this China Phase I bridging study is to to evaluate the safety, tolerability~     and pharmacokinetic profile of telatinib in China patients with advanced solid tumor~   "
29913|NCT03175484|"~     High-fidelity simulation (HFS) is a learning method extensively used for training of surgical~     specialty (including anesthesia) and nurses. It has a beneficial effect on knowledge of~     algorithms, team working, early warning scores, and communication. Various skills can be~     learned using a standardized simulation programs.~      The complexity of instructional design may produce cognitive overload, high stress level and~     anxiety. This may increase fatigue, facilitate errors, and is associated with inferior task~     performance which may impede memorization of learned skills resulting in inefficient~     learning/simulation failure. Subjectively reported scales can accurately identify the level~     of perceived workload and mental demand in individuals during simulation tasks. One example~     is the National Aeronautics and Space Administration (NASA)-TLX - the most accepted~     subjective measure of human workload in various industries including medicine.~      Surgical specialty (including anesthesia) and nurses training curriculum in Lyon, France,~     includes several HFS scenarios with a large panel of critical events. The investigators aim~     to evaluate the effect of burden of workload and stress perceived by surgical specialty~     (including anesthesia) residents and nurses during HFS on the learning performance, and to~     grade different learning scenarios by their difficulty.~   "
29914|NCT03175471|"~     Autoimmune liver diseases (AILD), which include Primary Sclerosing Cholangitis (PSC) and~     Autoimmune Hepatitis (AIH) are a common etiological factors for chronic liver disease among~     adolescents. In all these conditions, autoimmune lymphocyte responses are thought to~     orchestrate inflammatory injury against hepatocytes (primarily in AIH) or cholangiocytes (in~     PSC). In this proposal we aim to evaluate the Magnetic Resonance Imaging (MRI) modalities; MR~     cholangiopancreatography (MRCP) and MR elastography (MREL), as non-invasive biomarkers to~     assess two primary pathophysiological processes of AILD: bile duct damage and liver fibrosis.~     In this cross-sectional study MRI based findings of bile duct injury and liver fibrosis will~     be correlated with both liver histology and circulating biomarkers of these disease~     processes.~   "
29915|NCT03175458|"~     30 recruited patients indicated for sinus membrane elevation with simultaneous implant~     placement. patients are divided into 2 groups each group contain 15 patients, one group~     assigned for placement of bovine bone graft after membrane elevation and insertion of the~     implants while the other group assigned for graft-less tenting technique after membrane~     elevation and insertion of the implant.~   "
29916|NCT03175445|"~     Sexual dimorphism analysis in Egyptian population by locating the mandibular canal using~     cone-beam computed tomography: an observational cross sectional study~   "
29917|NCT03175432|"~     The goal of this clinical research study is to learn if atezolizumab and bevacizumab can help~     to control the disease in patients with cancer that has spread to the brain.~      The safety of this drug combination will also be studied.~      This is an investigational study. Bevacizumab is FDA approved and commercially available to~     treat certain types of cervical, ovarian, Fallopian tube, peritoneal, colorectal, lung,~     brain, and kidney cancer. Atezolizumab is FDA approved and commercially available to treat~     certain types of lung and urinary system cancer. The combination of bevacizumab and~     atezolizumab is investigational. The study doctor can explain how the study drugs are~     designed to work.~      Up to 40 participants will be enrolled in this study. All will take part at MD Anderson.~   "
29918|NCT03175419|"~     Setting up a Prospective Belgian National Registry of patients undergoing minimally invasive~     liver resections will allow the constitution of a national network able to get updated~     information on indication and results. Data will be of great importance for additional~     scientific projects aimed to clarify the role of minimally invasive approach in surgical~     liver pathology, especially malignancies.~   "
29919|NCT03175406|"~     Pre induction assessment using bishop scoring system and Manipal cervical scoring system~     performed on 105 pregnant females~   "
29951|NCT03174990|"~     This study evaluates the effects of Aspirin and thienopyridine resistance in relation to~     clinical cardiovascular outcomes as the genetic predictors of, and outcomes associated with~     aspirin and thienopyridine resistance in patients with peripheral arterial disease (PAD)~     currently remain unknown.~   "
29952|NCT03174977|"~     This is a single-center drug distribution and pharmacokinetic study of a single microdose of~     18F-raltegravir given to 10 HIV-infected subjects who are either taking or not taking a~     raltegravir-containing ART regimen. After administration of IV 18F-raltegravir, subjects will~     undergo PET/MRI in order to determine the distribution of radiolabeled drug through the~     lymphoreticular system and other tissues throughout the entire body.~   "
29920|NCT03175393|"~     Coronary artery disease (CAD) is usually used to refer to the pathological problem affecting~     the coronary arteries (usually atherosclerosis) that leads to Coronary Heart disease (CHD)~     which includes the diagnoses of angina pectoris, MI and silent myocardial ischemia.~      Despite the mortality for this condition has gradually declined over the last decades in~     western countries, it still causes about one-third of all deaths in people older than 35~     years.~      Dyslipidemia is very important risk factors of atherosclerosis that is one of the causes~     leading to cardiovascular disease Despite management of dyslipidemia by controling fasting~     total plasma cholesterol and LDL cholesterol as these are the best biomarkers for prediction~     of cardiovascular diseases (CVD) risk.~      LDL elevation is absent in many patients with atherosclerosis and about 1/3 of cardiac events~     remains to be unpredicted using this method. Even more, in fasting normolipidemic subjects,~     increased CVD risk is associated with an exaggerated postprandial lipemic response.~      Postprandial dyslipidemia is defined as a rise in triglyceride-rich lipoproteins (TRLs),~     including chylomicron remnants (CMRs) and remnant lipoproteins (RLPs), after eating, has~     drawn an increasing interest recently because of its association with cardiovascular events.~     Chylomicron remnants (CMRs) have been shown to penetrate the artery wall and to be retained~     within the intima.~      Endothelial dysfunction is an initial process of atherogenesis and it contributes to the~     pathogenesis of CHD. Postprandial hyperlipidemia (postprandial hypertriglyceridemia) is~     involved in the production of proinflammatory cytokines, recruitment of neutrophils, and~     generation of oxidative stress, resulting in endothelial dysfunction~   "
29921|NCT03175380|"~     This protocol will use leukapheresis to collect lymphocytes to study immune responses~     following vaccination with BCG in BCG-naïve participants. These studies will include, but not~     necessarily be limited to: anti-T-cell and anti-Natural Killer (NK) T-cell responses,~     anti-lipid responses, and antibody responses to BCG following re-vaccination. These responses~     will provide a detailed framework characterizing the immune responses that are induced and~     responses that are not induced in humans by BCG, a partially protective TB vaccine. This~     framework will allow new hypotheses to be formulated and tested regarding what new and more~     effective TB vaccines should target for optimal protective immunity.~   "
29922|NCT03175367|"~     The primary objective of the study is to evaluate the reduction of low-density lipoprotein~     cholesterol (LDL-C) by evinacumab in comparison to placebo after 16 weeks in patients with~     primary hypercholesterolemia (heterozygous familial hypercholesterolemia [HeFH], or non-HeFH~     with a history of clinical atherosclerotic cardiovascular disease [clinical ASCVD]) with~     LDL-C ≥ 100 mg/dL (2.59 mmol/L) despite maximally tolerated statin and proprotein convertase~     subtilisin/kexin type 9 (PCSK9) inhibitor therapy.~   "
29923|NCT03175354|"~     This is a randomized, double-blind, vehicle-controlled study to evaluate the safety and~     efficacy of ALX-101 Gel 1.5% and 5% and a matching ALX-101 Gel Vehicle when applied topically~     twice daily for 42 days to adult and adolescent subjects with moderate atopic dermatitis.~   "
29924|NCT03175341|"~     Forty years ago clinical studies conducted by Ewan Cameron and Linus Pauling suggested that~     intravenous (IV) and oral ascorbic acid (AA) may diminish symptoms and could improve survival~     in terminal cancer patients. Previous phase I and II clinical trials have found that high~     dose (1.5g/kg ) iv AA is well tolerated in cancer patients. This is a phase I/II, randomized~     study of parenteral administration of Ascorbic Acid (AA) as a supplement to the conventional~     neo-adjuvant chemotherapy in women with breast cancer.~   "
29925|NCT03175328|"~     Sepsis continues to be a major global cause of both mortality and morbidity. Furthermore, the~     development of acute kidney injury (AKI) in sepsis increases the risk of unfavorable~     outcomes. Besides source control, fluid resuscitation and the use of antibiotics, application~     of extracorporeal renal replacement therapies (RRT) is the predominant treatment for~     sepsis-associated AKI (SAKI). However, the timing of initiation of RRT remains controversial.~     It is reported that a correlation was observed between the concentrations of circulating~     inflammatory cytokines and mortality in patients with septic shock. Therefore, it is~     hypothesis that adequate removal of inflammatory mediators from the circulation may provide a~     potential therapy for this devastating condition. Indeed, data from meta-analyses,~     observational studies and randomized controlled trial (RCT) suggests that initiating RRT in~     critical ill patients (including patients with sepsis and non-sepsis) at early stage may be~     beneficial. But in some studies, initiating RRT at early stage do not shown to improve~     survival compared with initiating RRT at late stage. At present, large-scale prospective RCT~     about the timing for initiating RRT in SAKI was still lack.The decision when to start RRT is~     not merely academic but may impact on outcomes. Therefore, in our study, 600 patients with~     SAKI at KDIGO 2 from multicenter in China will be recruited. And then the patients will be~     divided into early group and delayed group randomly. In the early group, continuous RRT~     (CRRT) was started immediately after randomization. In the delay group, CRRT was initiated if~     at least one of the following criteria was met: KDIGO 3, severe hyperkalemia, metabolic~     acidosis, pulmonary edema, blood urea nitrogen level higher than 112 mg per deciliter, or~     oliguria for more than 72 hours after randomization. Overall survival at day 90 will be~     observed in order to understand whether different CRRT strategy would affect the outcomes of~     SAKI. This clinical study will be a large-scale, multi center, prospective, randomized trial~     about SAKI. It will help clinician choose appropriate timing to initiate CRRT and improve~     outcomes of SAKI.~   "
29926|NCT03175315|"~     This study is a randomized, controlled, prospective trial with a 6-month follow- up. A newly~     developed psychoeducational treatment and education programme for diabetic patients on an~     insulin therapy who use flash glucose monitoring (FGM) will be tested compared to a waiting~     group. Primary outcome variable is the difference in glycemic control between baseline and~     the 6-month follow-up. Secondary outcome variables are: time-in-range, frequency and duration~     of hypo- and hyperglycemic episodes, diabetes-related distress, depressive symptoms,~     health-related quality of life, diabetes self-efficacy, self-care behavior, and hypoglycemia~     awareness.~   "
29927|NCT03175302|"~     This study leverages a modernized digital version of a well-known cognitive screening tool to~     examine pre and post operative cognitive function after surgery in adults age 65 years or~     more. Machine learning algorithms will be applied to the hospital wide standard of care~     cognitive metric to identify risk for post-operative cognitive complications.~   "
29928|NCT03175289|"~     This randomized clinical trial studies how well expiratory muscle strength training works in~     improving bulbar function and quality of life in patients with head and neck cancer.~     Expiratory muscle strength training may help to strengthen the muscles involved in breathing~     and swallowing and may allow improved breathing, airway safety, swallow function, and quality~     of life in patients with head and neck cancer.~   "
29929|NCT03175276|"~     To investigate the usefulness of the Informant Questionaire on Cognitive Decline in the~     Elderly (IQCODE) to predict delirium in elderly patients admitted to Emergency Department~     (ED) with geriatric assessment and transferred to Geriatric ward.~   "
29930|NCT03175263|"~     This study was an observational, open-label, cohort-study conducted in accordance with the~     principles of the Helsinki Declaration. We prospectively and systematically recorded data~     from the patients and analyzed them retrospectively. During a first phase, called adaptation~     period, the injector (DR) used a follow-the-pain approach in order to determine the optimal~     injection scheme for each individual. The possible injection sites were the corrugator,~     temporalis, and trapezius muscles. Patients were systematically asked about the usual~     topography and time course of migraine attacks, and the existence of pain or stiffness of the~     cervical muscles. If the pain was predominantly located in the frontotemporal area, the~     corrugator and temporalis muscles were injected bilaterally. When the patients had~     predominant pain in the back of the head, or when their headache pain frequently started~     and/or ended in the trapezius muscles, both trapezius muscles were injected. These muscle~     groups were injected together if pain was both frontotemporal and cervico-occipital. When~     this first set of injections was efficacious, patients were re-injected in the same manner at~     the time when the frequency of headache days definitely increased. In the absence of~     efficacy, the paradigm was modified using the same follow-the-pain approach. Once the best~     procedure was determined for each patient, it was reproduced at each subsequent injection~     session. This adaptation phase could necessitate up to three sessions. The observation period~     started 8 weeks before the first efficacious injection and ended 2 months after the second~     consecutive efficacious injection, or in case of inefficacy. Throughout the adaptation and~     the observation phases, patients kept a headache diary where they were asked to note the days~     with headache and the use of rescue medication.~   "
29931|NCT03175250|"~     A randomized trial was conducted at drug diversion educational programs with a sample of 343~     adult drug offenders who volunteered for the study. The trial tested three different~     interventions on HIV testing and condom use, with a 3 month follow-up. The study translated~     consistent basic research showing strong effects of memory practice on memory for new~     material. One of the conditions involved extensive memory practice of action plans involving~     HIV testing and condom use. Other conditions varied two active control interventions. Results~     showed that the memory practice condition led to a substantially larger odds of HIV testing~     than did the two control conditions. Condom use was also significantly more frequent in the~     memory practice condition than in one of the control conditions but was not significantly~     different from the second control condition.~   "
29932|NCT03175237|"~     To evaluate the benefits of Mirror Therapy (MT) and motivation in patients with different~     levels of post-stroke motor impairment with two different therapy protocols. This is a~     randomized uncontrolled blinded study, with 27 individuals in the chronic phase of stroke.~     Participants were randomized into two intervention groups: MT group with motor patterns of~     movement (MP, n=13) and MT group with specific functional activities (SA, n=14). Motor~     impairment assessments (Fugl-Meyer Assessment - FMA), motivation (Intrinsic Motivation~     Inventory) and functionality (Functional Independence Measure - FIM) were performed before~     and after treatment, and 3 months after the end of sessions (follow-up). In each intervention~     group,there were patients classified with mild, moderate or severe motor impairment,~     according to FMA. All participants performed 15 MT sessions, 3 times a week for 50 minutes~     each session.~   "
29933|NCT03175224|"~     The purpose of this study is to determine the safety, tolerability, and recommended dose of~     CBT-101 in individuals with advanced solid tumors and c-MET dysregulation.~   "
29934|NCT03175211|"~     The primary objective of this trial is to investigate the safety and tolerability of BI~     456906 in healthy subjects following single rising doses.~      The secondary objective is the exploration of the pharmacokinetics including dose~     proportionality, and pharmacodynamics (PD) of BI 456906 after single dosing~   "
29935|NCT03175198|"~     The study objective is to confirm appropriate use and safety profile of Prazaxa® Capsules in~     real-world setting after the availability of idarucizumab~   "
29936|NCT03175185|"~     The aim of this study is to carry out a psychological evaluation for the parents of children~     diagnosed with attention deficit hyperactivity disorder (ADHD) and parents of children~     without ADHD as control to detect any psychological problems in those of children with ADHD .~     These problems may be a precipitating factor to cause ADHD in their child or have a genetic~     predisposition to be passed to their children. On the other hand these psychological problems~     may be caused by the difficulties they encounter in raising their ADHD child. The exact~     relation needs more researches and to be more investigated.~   "
29937|NCT03175172|"~     The purpose of this study is to evaluate whether CRS-207 with pembrolizumab is safe and~     effective in adults with MPM who have failed prior anti-cancer therapy.~   "
29938|NCT03175159|"~     This study seeks primarily to test, in a three-arm randomized controlled trial (RCT), the~     efficacy of Project IMPACT, an intervention that integrates Behavioral Activation (BA) with~     HIV risk reduction (RR) counseling for HIV-uninfected men who have sex with men (MSM) with~     stimulant use disorder at risk for HIV via sexual behavior. HIV-uninfected MSM with a~     diagnosis of stimulant use disorder will be randomized 2:2:1 to three arms: (1) the Project~     IMPACT intervention, BA-RR counseling, which lasts ten sessions; (2) the time- and~     intensity-matched control condition, including ten sessions of relaxation therapy with~     educational support; and (3) the standard of care (SOC) comparison condition, including two~     equivalent sexual risk-reduction counseling sessions. Participants will be followed for one~     year post-randomization, with assessments at months four, eight, and 12.~   "
29939|NCT03175146|"~     The proposed study will evaluate if curative intent SBRT can provide high response rates~     and clinically meaningful cancer control with acceptable toxicity specifically in patient~     with metastatic colorectal cancer (mCRC) who do not have surgical options and are no longer~     responding to systemic therapy~   "
29961|NCT03174860|"~     The purpose of this study is to assess the effect of preoperative Diclofenac Potassium (50 mg~     Cataflam) on the anesthetic success of buccal infiltration with 4% articaine with epinephrine~     1:200,000 in mandibular molars with symptomatic irreversible pulpitis.~   "
29989|NCT03174496|"~     This pilot study will investigate the feasibility of physical activity tracking in patients~     aged 4-16 years before and after elective tonsillectomy as an innovative tool in paediatric~     research. The participating patients will receive a wearable physical activity tracker~     (CE-certified) that will continuously measure the patients' physical activity before and~     after an elective tonsillectomy, in addition to their parents' documentation of their child's~     activity in a conventional diary.~   "
29940|NCT03175133|"~     This study will pilot a strengthening intervention targeted to muscles found to be important~     to gait in people with multiple sclerosis (MS). Previous studies that have tried to~     strengthen leg and trunk muscles in people with MS have failed to improve walking ability~     consistently. The investigators think that is because strengthening exercises were not~     targeted to the correct muscle groups. For this study the investigators propose targeting~     muscle groups that they have found to be strong contributors to walking in a prior study.~     This is the first study to target these muscles, so the investigators propose doing a small~     trial to first evaluate the feasibility of the strength program and the outcomes. The~     investigators will measure strength and walking measures twice before and once after an~     8-week strengthening intervention in a single group of 10 people with MS who are able to walk~     independently. The results of this study will help inform future, larger trials that could~     change the way strength training is conducted in people with MS.~   "
29941|NCT03175120|"~     This trial is conducted in Asia. The aim of this trial is to confirm the superiority of~     insulin degludec/liraglutide versus insulin degludec in controlling glycaemia in Chinese~     subjects with type 2 diabetes mellitus after 26 weeks of treatment~   "
29942|NCT03175107|"~     The purpose of the PD_manager project is to explore and develop innovative ecosystem~     management for people with Parkinson's disease. The research part contains expert analysis of~     diagnostic tests and decomposition of activity, accompanied by modern IT. The results of the~     analysis will be compared with the results of clinical trials that fall under the routine~     clinical pathways in monitoring a patient with Parkinson's disease. The primary motor~     symptoms, such as tremor, bradykinesia and impaired balance, and other symptoms, such as~     sleep disturbances, speech and cognitive perception, will be assessed by unobtrusive sensors~     (shoe insoles, bracelets) and sensors embedded in a mobile phone. The collected data will be~     analyzed using data mining methods and a platform for clinical decision support will be~     developed. This way, dependency of the patients on other persons will be reduced and the~     patients' quality of life improved. The patients will be motivated to follow the prescribed~     diet and take regular medication; the patients' activities will be monitored by occupational~     therapists and physiotherapists. A technical system will be designed as a computing platform~     in the open architecture cloud (FI-WARE), which will allow the use of commercially available~     sensors.~   "
29943|NCT03175094|"~     After enrollment, participants will be randomized to either receive the intervention~     (treatment) from trained health educators or undergo observation as usual (control group).~     Randomization will be stratified by HIV serostatus. A control group is appropriate because~     participants will still receive services offered through probation and will be offered the~     intervention after completion of the trial. Subjects will be paid, not for participating in~     the intervention, but for providing research assessments. The newly adapted intervention will~     be delivered over no more than a 3-month period (it will be shorter if the adaptation process~     is supportive). Baseline assessments will assess the pre-intervention period. The 3-month~     assessment will be the end-of-intervention effects and the post-intervention assessments will~     be at 6, 9 and 12 months. HIV prevention knowledge will be assessed based on quizzes used~     previously for HHRP+; though final quiz content will depend on final selected materials for~     the intervention. Subjects will be followed for 12 months with assessments by trained~     research assistants.~   "
29944|NCT03175081|"~     Obesity is a metabolic disorder that has gradually become a prevalent public health problem~     and is becoming one of the leading causes of death and disability worldwide. The most~     efficacious therapy for morbid obesity today is bariatric surgery. Bariatric surgery~     increases life expectancy by correcting the comorbidities associated with obesity, improves~     the quality of life, and is associated with reduced morbidity and mortality. There is an~     increase application of laparoscopic procedures as it is considered to cause less pain than~     traditional open surgery, smaller incision, reduced blood loss and shorter postoperative~     stay, which cuts down on hospital cost. However, postoperative pain still exists causing~     unpleasant experience for the patient and at times causes a delayed discharge. Pain after~     bariatric surgery is a result of many mechanisms such as tissue injury, abdominal distention,~     local trauma of the stomach, chemical irritation of the peritoneum, and the pneumoperitoneum~     and this pain potentially can prolong hospital stay and lead to increased morbidity, and~     bariatric surgeons are striving to minimize the morbidity of current procedures to improve~     patient outcomes and this gave rise to the use of intraperitoneal local anesthetics (LA). It~     was found that the use of intraperitoneal LA in laparoscopic cholecystectomy is safe, and it~     results in a statistically significant reduction in early postoperative abdominal pain. Many~     studies were done to evaluate the efficacy of intraperitoneal LA in laparoscopic~     cholecystectomy, gynecologic procedures and appendectomy but to date there are limited~     studies done to evaluate the role of intraperitoneal LA in bariatric surgery. The aim of this~     study is to evaluate the effectiveness of intraperitoneal instillation of local ropivacaine~     on postoperative abdominal pain after bariatric surgery. We hypothesized that the~     administration of intraperitoneal instillation of local ropivacaine would help reduce~     postoperative pain.~   "
29945|NCT03175068|"~     Many patients with Major Depressive Disorder (MDD) and generalized Social Anxiety Disorder~     (gSAD) are treated with cognitive behavioral therapy (CBT) but few have meaningful~     improvement. MDD and gSAD are diseases of brain dysfunction that manifest as impaired emotion~     regulation; CBT teaches emotion regulation strategies but how it works in the brain remains~     largely unknown. Individual differences in brain function related to emotion regulation may~     make some patients better suited for CBT and CBT may remedy the brain dysfunction that~     underlies these disorders. This project will compare CBT with a placebo psychotherapy (i.e.,~     supportive therapy) in MDD and gSAD to test, validate, and refine brain-based markers and~     examine mechanisms of change to examine how CBT works and for whom.~   "
29946|NCT03175055|"~     This study will evaluate the Phoenix device for safety and effectiveness at allowing persons~     with SCI who are non-ambulatory or poorly ambulatory to stand up and walk under a variety of~     conditions.~   "
29947|NCT03175042|"~     Pregnant patients in the UT Medical Branch outpatient obstetric clinic are screened for~     anemia via blood draw at first prenatal visit. Those who meet Center for Disease Control~     (CDC) criteria for anemia during pregnancy (hemoglobin less than 11g/dL in first and third~     trimesters and hemoglobin less than 10.5g/dL during the second trimester), will be approached~     for participation in this study. It is the protocol of the UT Medical Branch outpatient~     obstetric clinic to repeat a blood draw every 4 weeks in patients with anemia. At the time of~     their blood draw, patients who participate in our study will have the Masimo Spot~     Non-invasive Hemoglobin monitor placed on our finger. The primary aim of the study is to see~     how accurate the non-invasive monitor is compared with blood draw. With the potential benefit~     being earlier diagnosis of anemia and easier method to ensure improvement in the hemoglobin.~   "
29948|NCT03175029|"~     The purpose of this study is to evaluate the efficacy and safety of TAC-302 in detrusor~     underactivity patients with overactive bladder.~   "
29953|NCT03174964|"~     Infertility and miscarriage ordinary events in reproductive failure in humans, as are~     affected one couple in every six couples of reproductive age and abortion is including in~     approximately 15-20% of all pregnancies. Over the decades since the beginning of Assisted~     Reproductive Technology (ART) and in vitro fertilization (IVF) pregnancy rate still remains~     below 30% and Recurrent Implantation Failure in one of the most important limiting factor is~     the assisted reproductive techniques. According to studies conducted in recent years one of~     the most important mechanisms of implantation failure is maternal immune system because the~     fetus as an allograft toxic (Semi allograft) to the mother. Studies have demonstrated that~     ratio of Th1 to Th2 cells increase in maternal peripheral blood cells can be directly~     associated with implantation failure. It also increases the number of natural killer (NK)~     cells and Th17 cells and their cytokines in peripheral blood of mother and is also associated~     with an increased risk of infertility. Several studies have also shown that the fertile~     persons in compare to infertile have increased amount of Treg cells and inhibitory cytokines~     associated with it. The studies have shown that if patients are properly selected RIF and~     placed under appropriate immunotherapy approaches it will be seen a significant increase in~     fertility. In previous years, followed by the production of intravenous immunoglobulin (IVIg)~     and determine its effect on immune suppression, IVIg uses for the treatment of various~     diseases such as thrombocytopenic purpura, Guillain-Barre syndrome, Kawasaki disease and~     Myasthenia gravis. It is also valuable drug for the treatment of patients with infertility~     problems have also been used but still remains how well the drug and its mechanism of action~     are unknown. Probably one of the mechanisms of IVIg is its effect in suppressing the activity~     of NK cells. Likely IVIg cause to increase Cluster of Differentiation 94 (CD94) molecule as~     an inhibitor molecule on the NK cells and reduced the cytotoxic activity of NK cells. So~     because of reduce the cytotoxic activity of NK cells by IVIg in patients with RIF injection~     increases the likelihood of successful implantation. Previous studies have shown that the~     incidence of genetic abnormalities in children who have received immunosuppressive drugs such~     as IVIg like normal people and normal society. In this study we used IVIg before IVF to~     suppress the immune system in patients with immunological causes of RIF and the results will~     be compared with a control group that did not receive any type of drug.~   "
29954|NCT03174951|"~     Infertility and miscarriage ordinary events in reproductive failure in humans, as are~     affected one couple in every six couples of reproductive age and abortion is including in~     approximately 15-20% of all pregnancies. Over the decades since the beginning of Assisted~     Reproductive Technology (ART) and in vitro fertilization (IVF) pregnancy rate still remains~     below 30% and Recurrent Implantation Failure in one of the most important limiting factor is~     the assisted reproductive techniques. Determine the causes of Recurrent Pregnancy Loss (RPL)~     can raise the success rate of assisted reproductive techniques and hope infertile couples and~     reduce psychological pressure on them and also reduce costs is very important. According to~     studies conducted in recent years one of the most important mechanisms of recurrent~     miscarriage is maternal immune system because the fetus as an allograft toxic (Semi~     allograft) to the mother. Studies have demonstrated that ratio of Th1 to Th2 cells increase~     in maternal peripheral blood cells can be directly associated with recurrent pregnancy loss.~     It also increases the number of Natural killer (NK) cells and Th17 cells and their cytokines~     in peripheral blood of mother and is also associated with an increased risk of infertility.~     Several studies have also shown that the fertile persons in compare to infertile have~     increased amount of Treg cells and inhibitory cytokines associated with it. The studies have~     shown that if patients are properly selected RPL and placed under appropriate immunotherapy~     approaches it will be seen a significant increase in fertility. In previous years, followed~     by the production of intravenous immunoglobulin (IVIg) and determine its effect on immune~     suppression, IVIg uses for the treatment of various diseases such as thrombocytopenic~     purpura, Guillain-Barre syndrome, Kawasaki disease and Myasthenia gravis. It is also valuable~     drug for the treatment of patients with infertility problems have also been used but still~     remains how well the drug and its mechanism of action are unknown. Probably one of the~     mechanisms of IVIg is its effect in suppressing the activity of NK cells. Likely IVIg cause~     to increase Cluster of Differentiation 94 (CD94) molecule as an inhibitor molecule on the NK~     cells and reduced the cytotoxic activity of NK cells. So because of reduce the cytotoxic~     activity of NK cells by IVIg in patients with RPL injection increases the likelihood of~     successful pregnancy. Previous studies have shown that the incidence of genetic abnormalities~     in children who have received immunosuppressive drugs such as IVIg like normal people and~     normal society. In this study we used IVIg before IVF to suppress the immune system in~     patients with immunological causes of RPL and the results will be compared with a control~     group that did not receive any type of drug.~   "
29955|NCT03174938|"~     The Swedish BioFINDER 2 study is a new study that will launch in 2017 and extends the~     previous cohorts of BioFINDER 1 study (www.biofinder.se). BioFINDER 1 is used e.g. to~     characterize the role of beta-amyloid pathology in early diagnosis of Alzheimer's disease~     (AD) using amyloid-PET (18F-Flutemetamol) and Aβ analysis in cerebrospinal fluid samples. The~     BioFINDER 1 study has resulted in more than 40 publications during the last three years, many~     in high impact journals, and some the of the results have already had important implications~     for the diagnostic work-up patients with AD in the clinical routine practice.~      The original BioFINDER 1 cohort started to include participants in 2008. Since then there has~     been a rapid development of biochemical and neuroimaging technologies which enable novel ways~     to the study biological processes involved in Alzheimer's disease in living people. There has~     also been a growing interest in the earliest stages of AD and other neurodegenerative~     diseases. With the advent of new tau-PET tracers there is now an opportunity to elucidate the~     role of tau pathology in the pathogenesis of AD and other tauopathies. The Swedish BioFINDER~     2 study has been designed to complement the BioFINDER 1 study and to e.g. address issues~     regarding the role of tau pathology in different dementias and in preclinical stages of~     different dementia diseases. Further, the clinical assessments and MRI methods have been~     further optimized compared to BioFINDER 1.~   "
29956|NCT03174925|"~     This clinical trial studies how well ultrasound elastography works in imaging patients with~     thyroid nodules. Diagnostic imaging, such as elastography, uses shear waves to measure the~     stiffness and compressibility of tissue and may be a better way to image thyroid nodules.~   "
29957|NCT03174912|"~     Investigators aimed to evaluate the performance of The European Organization for Research and~     Treatment of Cancer(EORTC) and the Spanish Urology Association for Oncological~     Treatment(CUETO) risk tables on all non-muscle invasive bladder cancer patients(NMIBC), and~     those not treated with BCG and treated with BCG separately.~   "
29958|NCT03174899|"~     Chronic kidney disease (CKD) is a common global public health problem and the average~     incidence of end-stage renal disease in developing countries is 150 per million population,~     which is lower than that in the developed world~   "
29959|NCT03174886|"~     This study is a pilot trial evaluating the safety and immunogenicity of AADvac1 in patients~     with the non-fluent variant of Primary Progressive Aphasia.~      50% of participants will receive the 40 µg dosage of AADvac1 and 50% of participants will~     receive the 160 µg dosage of AADvac1. No placebo is used.~   "
29960|NCT03174873|"~     Ray and colleagues define unexplained infertility as failure to achieve pregnancy when the~     semen analysis is normal, evidence for ovulation is present, and tubal patency has been~     established. The efficacy of treatment declines with increasing age and duration of~     infertility Infertility is a disease , defined by the failure to achieve a successful~     pregnancy after 12 months or more of appropriate, timed unprotected intercourse or~     therapeutic donor insemination, barber evaluation and treatment may be justified based on~     medical history and physical findings and is warranted after 6 months for women over age 35~     years.~      In unexplained infertility abnormalities are likely to be present but not detected by current~     methods including semen analysis in the man, assessment of the state of ovulation, ovulation~     reserve and patency of uterine tubes in the woman.~      unexplained infertility is not a rare item of infertility. Approximately 15% of infertility~     couple will be diagnosed with unexplained infertility after their diagnostic workup Many~     researches studied the laparoscopic tubal factor like tubo-ovarian relation, tubal kinks and~     fimbrial pathology. But we need to scope on more tubal factors like fatty mesosalpinx ,~     fimbria ovarica, methylene blue free spill and others~   "
29962|NCT03174847|"~     Majority of patients with hypertension have primary hypertension (without an underlying~     cause). Secondary hypertension (due to an underlying disease) is important to recognize, as~     treatment can lead to cure of hypertension. Primary aldosteronism (PA) is the most common~     cause of secondary hypertension, and can be found in 5-10% of patients locally.~      PA is caused by excessive release of a hormone (aldosterone) from the adrenal glands, which~     can be unilateral (one gland) or bilateral (both glands). Distinction between two is crucial~     as unilateral disease is treated with the aim of cure by surgery, and bilateral disease is~     treated by medication.~      It has been shown that excess aldosterone has other harmful effects in addition to~     hypertension, such as directly affecting the heart, blood vessels, kidneys, diabetes and~     quality of life. This is supported by studies showing reversal of these effects after~     treatment for PA. In addition, improvements after surgery appears to be superior to medical~     treatment, although studies have found variable results.~      Hence, the investigators aim to accurately subtype patients with PA into unilateral or~     bilateral disease and study the post-treatment response after both surgery and medicine with~     regards to the effects on blood pressure, cardiovascular, renal, metabolic and quality of~     life.~   "
29963|NCT03174834|"~     Urinary tract infection is the most common serious bacterial infection among infants. Bladder~     catheterization is considered the gold standard for diagnosis, yet is painful and invasive.~     In contrast, the bladder stimulation technique has been shown to be a quick and non-invasive~     approach to collecting urine in young infants with a contamination rate similar to bladder~     catheterization. Previous research, however, relied upon trained study personnel thereby~     limiting the generalizability of their findings. By training staff in the pediatric emergency~     department, this study aims to evaluate the feasibility of incorporating this technique into~     routine clinical practice while also assessing its impact on parent and provider~     satisfaction.~   "
29964|NCT03174821|"~     The recent study suggested that oxidative stress resulting from increased production of~     reactive oxygen species (ROS) plays a crucial role in the development of diabetic~     complications. The researches aim to monitor the level of oxidative stress of patient in~     different stage of diabetic nephropathy before and after insulin pump therapy.~   "
29965|NCT03174808|"~     The primary objective is to assess the feasibly, adherence, and effects of mindfulness-based~     stress reduction (MBSR) on anxiety and health-related quality of life in adult patients with~     cutaneous T-cell lymphoma at the Yale Cancer Center/Smilow Cancer Hospital.~      Participants will attend group sessions led by an instructor experienced in MBSR in an~     academic setting. The mindfulness meditation group sessions will take place at the Smilow~     Cancer Center at the Yale New-Haven Hospital.~   "
29966|NCT03174795|"~     This is a non-randomized, open-label, one-treatment, one group study in participants with~     complicated urinary tract infection (cUTI) including pyelonephritis to characterize the~     pharmacokinetics of RO7079901 co-administered with meropenem.~   "
29967|NCT03174782|"~     This study will be a double-blinded randomized controlled trial analyzing all patients who~     will undergo major lower extremity amputations by the vascular surgery service at UCSF Fresno~     between July 2017 and June 2018 to determine if regional nerve blocks (sciatic and femoral)~     have any effect on postoperative pain control, narcotic requirements, and length of stay~     compared with standard post-operative narcotic regimens.~   "
29968|NCT03174769|"~     This evaluates the affect of protein quantity on indices of sleep. Half the participants will~     be prescribed protein in the amount consistent with the USDA healthy style eating pattern,~     while the other half will be prescribed a diet containing 12.5 oz eq of protein.~   "
29969|NCT03174756|"~     Hypochlorous acid (HOCl) in a non-antibiotic antimicrobial agent used in clinical medicine.~     Nevertheless, its antiplaque oral effect has not been evaluated. Chlorhexidine (CHX) is the~     gold standard as an antiplaque agent for its high substantivity in plaque and saliva. There~     are no published studies evaluating the substantivity of hypochlorous acid compared to CHX.~     Objective: To evaluate the efficacy of mouthwashes of HOCl in substantivity evaluated by~     reduction of bacterial viability in saliva during 7 hours compared to CHX rinses and a~     placebo.~   "
29970|NCT03174743|"~     The investigator will evaluate the influence of lung protective ventilation on postoperative~     clinical outcome in patients undergoing one-lung ventilation for pulmonary lobectomy.~   "
29971|NCT03174730|"~     This study evaluates a new digitally delivered mindset based intervention in addition to a~     smartphone application (app) for smoking cessation. Participants will be provided an app~     (SmartQuit) that teaches them skills to quit, and will be randomly assigned to either receive~     a growth mindset intervention or to a control group.~   "
29972|NCT03174717|"~     The goal of this study is to examine the impact of an individualized music program that~     includes music performance impacts quality of life, PRN drug use and scores on the RAI-MDS~     for residents of a long-term care facility. The impact of this program on staff at the~     long-term care facility and musicians performing at the facility will also be assessed.~   "
29973|NCT03174704|"~     Chronic Obstructive Pulmonary Disease (COPD) is the third leading cause of death, affects~     over 24 million people in the US and is the leading cause of disability with projected~     healthcare costs at almost $50 billion. The goal of this study is to identify novel and~     potentially powerful targets for behavioral interventions in COPD which has been understudied~     despite its tremendous detrimental impact on overall public health.~   "
29974|NCT03174691|"~     Until now very little information exists regarding the early luteal serum progesterone~     profile after Human chorionic gonadotropin (hCG) trigger. This pilot study will help~     characterize the serum progesterone, 17-hydroxyprogesterone profiles in IVF patients and~     correlate progesterone, 17-Hydroxyprogesterone levels to ovarian follicles obtained after~     stimulation with exogenous gonadotropins.~   "
29975|NCT03174678|"~     The aim of this retrospective study was to detect the effectiveness of 1µg/kg oral~     dexmedetomidine premedication on preoperative cooperation and emergence delirium of the the~     young children underwent complete dental treatment.~   "
29976|NCT03174665|"~     This study intends to compare the patients with pain with those who underwent same procedure~     without developing pain. The patients with pain and without pain will be further analyzed in~     respect to clinical differences, biomarkers and genetical differences.~   "
29990|NCT03174483|"~     To detect the effect of hypertonic saline and fluticasone sprays on computed tomography scan~     of paranasal sinuses of patients having chronic sinusitis and/or nasal polyps.~   "
29977|NCT03174652|"~     The global burden of maternal morbidity and mortality attributable to anemia is staggering,~     and this is especially true in low-resource settings. A recent review suggests 42% of~     pregnant women have anemia worldwide (1993-2005) with the vast majority of anemic women (90%)~     residing in Africa or Asia1; and in Asia, anemia was the second highest cause of maternal~     mortality2. Anemia was diagnosed in almost one third to one half of women presenting to the~     Shoklo Malaria Research Unit (SMRU) clinics on the Thai-Myanmar border for antenatal care~     (ANC) in a 2008 survey3, and anemia at first antenatal visit was associated with a two-fold~     increase in maternal mortality in this population4. Studies have also shown an association~     between anemia and small for gestational age infants, preterm delivery, infant and childhood~     anemia and developmental delays5.~      The anemia in pregnant women presenting to SMRU clinics is multifactorial, as~     hemoglobinopathies, Glucose-6-dehydrogenase (G6PD) deficiency, iron, folic acid and B12~     deficiency, helminth infection, and malaria are all prevalent in this rural population.~     Though all of these pathologies can cause anemia, they require different and sometimes~     conflicting treatment and prevention strategies, interacting in a complex web of causes and~     effects. Iron supplementation is the mainstay of most anemia control programs, but some women~     with hemoglobinopathies suffer from potentially fatal iron overload6. Iron supplementation~     has also been associated with increased risk of malaria7. Some helminth infections are~     associated with increased rates of anemia and malaria, but others may be protective8. Malaria~     and G6PD deficiency have complex effects on one another, and some malaria treatments can~     cause acute and life-threatening hemolysis in G6PD deficient individuals9.~      Given the high prevalence and diverse causes of anemia in this population, and its~     potentially dire effects on maternal and infant health and survival, SMRU implemented~     increased clinical testing for pregnant women in 2012 to inform clinical care at the~     individual level. Further analysis of these data is urgently needed to improve care on a~     population scale. We propose to review existing data from ANC records to determine the causes~     and effects of anemia in this population, and use this information to improve treatment and~     prevention guidelines. Results would be integrated rapidly into local practice with the~     potential to have profound impacts on maternal and child health in this region.~   "
29978|NCT03174639|"~     From July 2015 to December 2015, clinical record of 8 consecutive cases of macular hole with~     retinal detachment in high myopia treated with combined inverted and free ILM flap insertion~     into the hole were retrospectively reviewed. The anatomical and function outcomes were~     assessed.~   "
29979|NCT03174626|"~     The purpose of the pilot is to test the feasibility of developing and implementing the~     Williams LifeSkills Cancer Care (WLSCC) and examining its preliminary impact on caregiver~     well-being and patient well-being. The study is a two-arm randomized intervention pilot~     (WLSCC vs. Usual Care [UC]) with data collection at baseline, immediately after training, and~     2 weeks after completing the training. Study setting is at the breast and thoracic cancer~     clinics at the Duke Cancer Clinic. A total of 40 cancer patients (20 breast cancer patients~     and 20 lung cancer patients) and their caregivers (for a total N of 80) will be recruited for~     the pilot. The WLSCC will involve six 30-minute phone sessions and will encompass the~     application of 10 psychosocial skills within the context of cancer caregiving. Descriptive~     statistics will be used to detail recruitment/retention rate, fidelity rate, and the baseline~     demographic and clinical characteristics for the total sample and each group. Plots of the~     individual trajectories (within-person scores over time) will be used to identify the~     pattern(s) of change over time, and assess between-person variability in baseline values~     (intercepts) and trajectories (slopes). This study carries minimal risk to study~     participation.~   "
29980|NCT03174613|"~     1. To evaluate the safety and tolerability of LC51-0255 in healthy male subjects~        2. To evaluate the pharmacokinetic/pharmacodynamics characteristics (PK/PD) of LC51-0255 in~          healthy male subjects~        3. To evaluate bioavailability of LC51-0255~   "
29981|NCT03174600|"~     The course of post-stroke bladder problems and their relation with functional, mental status~     and quality of life: A six-month prospective, multicenter study~   "
29982|NCT03174587|"~     The purpose of conducting phase 1 trial to evaluate the safety and tolerability of allogenic~     bone marrow-derived mesenchymal stem cells(CS20AT04) in subjects with lupus nephritis.~      Evaluating DLT by IV injection according to dose-escalating in lupus nephritis patients.~   "
29983|NCT03174574|"~     Individuals who are affected with pancreas cancer and melanoma as well as those without~     either cancer who have been identified as 1st or 2nd degree relatives of family members with~     pancreas cancer and melanoma will be asked to participate. The participant will be asked to~     complete a survey about their health and family history of cancer and to give a blood sample~     for specific gene testing and storage for future research studies.The overall goal of this~     study is to understand the factors that increase susceptibility and expression of pancreatic~     cancer and melanoma in high risk families.~   "
29984|NCT03174561|"~     The study investigate the efficacy of the combination inuline, choline and silymarin in~     alleviating the symptomatology of the patients with irritable bowel syndrome with~     constipation in a randomized, cross-over, no treatment controlled study.~   "
29985|NCT03174548|"~     Primary Objective:~      To evaluate the effect of food on the single-dose pharmacokinetics of sotagliflozin relative~     to a fasted state in healthy adult male and female subjects.~      Secondary Objectives:~        -  To evaluate the effect of food on the single-dose pharmacokinetics of the main~          metabolite (sotagliflozin 3-O-glucuronide) relative to a fasted state in healthy adult~          male and female subjects.~        -  To investigate the relative bioavailability of sotagliflozin tablet to oral solution~          under fasting conditions~        -  To evaluate safety and tolerability of single-dose sotagliflozin under fed and fasted~          conditions in healthy adult male and female subjects.~   "
29986|NCT03174535|"~     The present study aims to develope a risk assessment model of ischemic stroke endpoint events~     combining multi-dimensional traditional Chinese medicine(TCM) indicators with modern medicine~     indicators. The proposed study is a registry study based participant survey conducted in 7~     hospitals nationwide in China. After obtaining informed consent, a total of 3000 study~     patients diagnosed with ischemic stroke will be recruited. 1-year follow-ups are carried out~     on-site in hospitals and by telephone to track endpoint events.~   "
29987|NCT03174522|"~     This trial is a pivotal, placebo-controlled, double-blind, parallel-group, adaptive trial~     conducted in subjects with DM and CLI Rutherford Category 5. Minimisation will be used to~     assign eligible subjects in a 2:1 ratio to receive a single intra-arterial administration of~     Rexmyelocel‑T or matching placebo into the index limb.~   "
29988|NCT03174509|"~     Laboratory studies suggest extubation with positive pressure because it reduces the volume of~     secretions filtered into the distal airway. The aim of this non inferiority study is to~     evaluate the safety of the extubation technique under positive pressure with respect to the~     traditional technique (with suction and without positive pressure in the airways).~   "
29991|NCT03174470|"~     The company suggests a new concept of treatment for PE: Transient inhibition of striated~     muscle contraction by a transcutaneous stimulation device. This study aim is to evaluate the~     safety of delivering increasing electrical stimulation intensities to the subject's perineum,~     using a TENS technique and equipment, followed by a 72-hour postoperative follow-up.~   "
29993|NCT03174444|"~     There have been few studies of small media interventions to promote colorectal cancer~     screening among Chinese Americans. Based on the results of strong preliminary studies on the~     promotion of colorectal cancer screening among Asian American populations, this~     community-academic research team propose to develop a culturally and linguistically~     appropriate traditional small media print brochure and a novel small media electronic~     audio-visual application accessible through mobile applications and through a website to~     promote CRC screening in English, Cantonese, and Mandarin. The team will test in a randomized~     controlled trial in 3 healthcare systems the efficacy of a combination of these small media~     interventions and a mailed patient reminder compared to usual care on increasing CRC~     screening among Chinese American patients.~   "
29994|NCT03174431|"~     This is a multi-centered randomized controlled trial of women with stress urinary~     incontinence or stress predominant mixed urinary incontinence who desire non-surgical~     therapy.~   "
29995|NCT03174418|"~     Investigator-initiated, international, multicentre, observational study with two cohorts.~      The two study cohorts will be:~      Cohort A: to understand if the local blood flow patterns (associated with low WSS), as~     evaluated by computational fluid dynamic tools from combined angiographic and OCT invasive~     images, may better predict the clinical outcome of patients with bifurcated coronary lesions~     treated by PCI.~      Cohort B: to understand if the local blood flow patterns (associated with low WSS), as~     evaluated by computational fluid dynamic tools from combined angiographic and OCT invasive~     images, may better predict the clinical outcome of patients with sub-critical bifurcated~     lesions managed conservatively.~      Coronary angiography and OCT images will be combined to obtain a three-dimensional model of~     the diseased coronary vessels that will be used to calculate the local blood flow patterns~     and the time-averaged WSS at the bifurcated lesion level by using computational fluid~     dynamics software.~      Baseline (in patients both managed conservatively and treated by PCI) and post-PCI (in~     patients treated by PCI) images will be processed.~   "
29996|NCT03174405|"~     AVETUX is a single arm multicentric phase II investigator initiated trial conducted by the~     Arbeitsgemeinschaft Internistische Onkologie (AIO) in 11 German sites in patients with~     previously untreated RAS/BRAF wildtype mCRC independent of MSI status.~   "
29997|NCT03174392|"~     Individuals poststroke with gait and balance impairment are typically less active and have~     low levels of physical fitness. Improving fitness level while also improving gait and balance~     is very important. Maximizing the exercise training benefit requires the appropriate level of~     effort is achieved. Traditional exercise programs scale aerobic demand by increasing the~     walking speed or the slope of the treadmill surface. This may be difficult for individuals~     who experience decreased balance at faster speeds or on sloped surfaces and require the use~     of handrails to safely walk under these conditions. These exercise programs show limited~     improvement in walking ability after training. This project will test a novel approach,~     resistance-based treadmill walking, for maximizing improvements in fitness and ability to~     walk by individuals poststroke. The investigators previous research has shown that backward~     directed resistive force applied to the pelvis while walking is well tolerated by individuals~     poststroke. Further, these forces can be used to effectively scale aerobic demand while~     walking in a controlled manner. With traditional treadmill training approaches handrail~     support is utilized to ensure safety. However, handrail support externally stabilizes the~     individual reducing training improvements in walking capacity and balance. For this pilot~     investigation a group that aerobically trains using a standard exercise treadmill training~     paradigm will be compared to a group that experiences progressive backward directed resistive~     forces applied to an individuals' pelvis while they walk at comfortable walking speeds~     without the aid of handrails. Individuals will wear a fall harness that provides no external~     stabilization but prevents falls to the treadmill surface. This approach has the potential~     benefit of allowing individuals poststroke to meaningfully practice walking at safe speeds~     but against resistance thereby improving walking economy, dynamic balance, and walking speed.~     The proposed project is necessary to gather preliminary data for a much larger training study~     that has the potential to change the clinical approach for improving gait economy, balance,~     and walking speed for individuals poststroke.~   "
29998|NCT03174379|"~     The purpose of this two-center study is to examine the effectiveness of acupuncture~     treatments in addressing mobility deficits, sensorimotor impairment, and quality of life~     (QOL) limitations in persons with Multiple Sclerosis (MS). It is hypothesized that~     acupuncture will result in an improvement in these limitations.~   "
29999|NCT03174366|"~     Charcot neuroarthropathy (CN) is a debilitating disease primarily affecting poorly controlled~     diabetic patients with peripheral neuropathy. The consequences of CN include ulcerations of~     the foot and ankle, osteomyelitis, and severe musculoskeletal deformity. These consequences~     frequently lead to below-knee amputation of the affected limb.~      Currently treatment options are limited, and no pharmaceutical treatment has been efficacious~     in the medical literature. The purpose of this pilot study is to investigate the potential of~     the medication denosumab for acute stage Charcot neuroarthropathy.~   "
30000|NCT03174353|"~     This is a single arm investigator-initiated study designed to test the feasibility and~     potential efficacy of preoperative lanreotide to reduce the risk of postoperative abscess or~     pancreatic leak and fistula. All consenting patients undergoing planned elective~     pancreaticoduodenectomy or distal pancreatectomy for malignancy or suspected malignancy will~     be treated with a single deep subcutaneous dose of lanreotide prior to planned resection on~     the day of surgery. Following this intervention, care will be based on standard treatment~     protocols. Sixty-day mortality and morbidity will be collected for all patients.~   "
30001|NCT03174340|"~     The main objective is to evaluate the effect of therapeutic exercise program on blood glucose~     regulation in women with gestational diabetes mellitus (GDM) who are assigned to~     diet-and-exercise, compared to diet only (usual treatment). The primary outcome is the need~     for insulin treatment in the two groups.~   "
30002|NCT03174327|"~     Interventional study with minimal risks and constraints, prospective, mono-centric.~   "
30003|NCT03174314|"~     This pilot study will integrate multi-sensor fusion techniques (software) to effectively~     combine information obtained from the newly embedded infrared, ultrasound, and~     stereo-camera-based sensor systems (hardware) that are implemented into the VIS4ION platform.~      The core of this technology is based on 4 components: (1) a wearable vest with several~     distinct range and image sensors embedded. These sensors extract pertinent information about~     obstacles and the environment, which are conveyed to (2) a haptic interface (belt) that~     communicates this spatial information to the end-user in real-time via an intuitive,~     ergonomic and personalized vibrotactile re-display along the torso. (3) A smartphone serves~     as a connectivity gateway and coordinates the core components through WiFi, bluetooth, and/or~     4G LTE, (4) a headset that contains both binaural, open-ear, bone conduction speakers~     (leaving the ear canal patent for ambient sounds) and a microphone for oral~     communication-based voice recognition during use of a virtual personal assistant (VPA).~      Blindfolded-sighted (50), and blind (50) subjects in a real-world, combined obstacle~     avoidance / navigation task will serve as an independent measure of overall improvements in~     the system as well as a roadmap for future avenues to enhance performance.~   "
30004|NCT03174301|"~     The objective of this common multicenter protocol is to test the hypothesis that algorithmic~     tools using clinical Neonatal Intensive Care Unit (NICU) cardiorespiratory monitoring data~     can detect ventilatory control instability and predict chronic and acute respiratory~     consequences of ventilatory control instability and autonomic dysregulation.~   "
30005|NCT03174288|"~     In this protocol, 60 subjects with DM1 will be studied at baseline, after 12 weeks of MCR~     blockade or 12 weeks of exercise, and again after an additional 12 weeks of MCR blockade,~     exercise or the combination of both interventions. The investigators will assess function in~     conduit (pulse wave velocity-PWV, flow-mediated dilation-FMD and augmentation index-AI),~     resistance (post-ischemic flow velocity-PIFV) and heart and skeletal muscle microvascular~     (contrast enhanced ultrasound-CEU) vessels before and after 2 hrs of a euglycemic insulin~     clamp.~      We hypothesize that compared to healthy controls, both baseline and insulin-responsive~     vascular function are impaired throughout the arterial vasculature by DM1 and that exercise~     training and/or mineralocorticoid receptor (MCR) blockade will improve both baseline and~     insulin-responsive pan-arterial function.~   "
30006|NCT03174275|"~     Participants in this study have a type of cancer called squamous cell carcinoma of the head~     and neck (SCCHN). Their SCCHN has spread around the area where the cancer first started. This~     is called locally-advanced SCCHN. These participants are eligible for surgery.~      Previous research with a similar therapy regimen resulted in high rates of cancer shrinkage,~     high rates of avoiding radiation and its side effects, high cure rate and good quality of~     life. Radiation can be very toxic. The purpose on this study is to try to avoid radiation. If~     the participants are not on this study they would be receiving radiation as it is standard~     treatment of their cancer. In the last study with a similar regimen, about a third of cancers~     had a pathologic complete response with the first part of the study. This means that the~     chemotherapy had killed the cancer. The investigators are trying to improve the regimen~     further with a goal of increasing this rate of complete response to the first part of~     therapy. The investigators also hope that by improving results in the first part, that more~     people will be cured and that long term quality of life (especially speech and swallowing)~     will be improved, both compared to standard therapies and to the last study. Doctors do not~     know how this therapy will effect the participants. There is no guarantee that this study~     will benefit the participants.~      The prior study used a combination of chemotherapy consisting of carboplatin, paclitaxel and~     a third targeted anti-cancer drug. In this study the investigators are testing the~     combination of carboplatin, nano-albumin bound paclitaxel and durvalumab. Nano-albumin bound~     paclitaxel has been shown to be more active against other types of squamous cancers than~     regular paclitaxel. It is FDA approved for squamous lung cancer, but experimental for head~     and neck cancer. Durvalumab is an experimental drug that uses the body's own immune system to~     fight the cancer. Doctors hope that combining Durvalumab with 2 chemotherapy drugs will be~     effective in treating SCCHN. Durvalumab on its own has been studied in patients with SCCHN~     and initial results have shown that some subjects' cancer has responded to it.~      The purpose of this study is to test a combination of chemotherapy to hopefully both increase~     the number of subjects that respond to therapy while also decreasing the number of side~     effects that subjects experience.~   "
30007|NCT03174262|"~     The study aims to determine whether a face to face ergonomic workstation intervention has any~     advantage over an online instructional training program for acquisition of knowledge,~     self-efficacy, and habit formation.~   "
30008|NCT03174249|"~     Consecutive patients with long-standing complex regional pain syndrome II in a lower limb are~     treated with graded exposure therapy in vivo in combination with methods targeting cortical~     reorganisation.~   "
30009|NCT03174236|"~     Children with severe malnutrition who are admitted sick to hospitals have a high~     mortality(death rate), usually because of infection. All children with severe malnutrition~     admitted to hospitals are treated with antibiotics(medication used to kill bacteria).~     However, the current antibiotics used in hospitals may not be the most effective. It is~     possible that the antibiotics that are currently used after initial antibiotics should be~     used first. No studies have been carried out to determine if the current antibiotics used for~     treating malnourished children who are sick and admitted in hospital are the most~     appropriate. The aim of this study is to find out if a changed antibiotic system for children~     with malnutrition is safe, reduces the risk of death and improves nutritional recovery.~   "
30010|NCT03174223|"~     Deep neuromuscular block (NMB) has shown to produce superior surgical conditions during~     various abdominal and non abdominal surgeries. It is however unknown if the application of~     deep NMB leads to favourable outcome, such as lower rate of postoperative complications in~     general and surgical infections in specific and ultimately lower readmission rates. In the~     leiden university medical center, deep NMB is routinely applied for a variety of procedures,~     most notably laparoscopic abdominal and retroperitoneal surgery, eye surgery and neuro~     radiologic intervention surgery, since 2014. This retrospective study intends to investigate~     whether the application of deep NMB for these procedures affects patient outcome and~     readmission rates.~   "
30011|NCT03174210|"~     The aim of this study is to investigate the effects of supplemental oxygen on blood~     oxygenation at rest in Patients with severe to very severe COPD comparing the portable oxygen~     concentrator (Activox™ 4L) to a liquid continuous oxygen device (Companion®).~   "
30012|NCT03174197|"~     There are 2 parts to this study: Part I and Part II.~      The goal of Part I of this clinical research study is to study the safety and tolerability of~     atezolizumab in combination with radiation therapy and temozolomide.~      The goal of Part II of this study is to learn if atezolizumab combined with radiation therapy~     and temozolomide can help to control glioblastoma.~      The safety of this combination will also be studied.~      This is an investigational study. Atezolizumab is FDA approved and commercially available for~     the treatment of several types of cancer, but not glioblastoma. Temozolomide is FDA approved~     and commercially available for the treatment of glioblastoma. The radiation therapy used in~     this study is being delivered using FDA-approved and commercially available methods.~      It is considered investigational to use atezolizumab in combination with temozolomide and~     radiation therapy to treat glioblastoma.~      The study doctor can describe how the study drugs and radiation are designed to work.~      Up to 60 participants will be enrolled in this study. All will take part at MD Anderson.~   "
30013|NCT03174184|"~     The overall goal of this exploratory proof-of-concept study is to determine whether, in~     participants with pulmonary tuberculosis caused by M. tuberculosis (MTB) with or without~     rifampin resistance-conferring rpoB-gene mutations, the combination of meropenem and~     amoxicillin/clavulanate with rifampin has greater early bactericidal activity (EBA) than the~     combination of meropenem and amoxicillin/clavulanate without rifampin.~   "
30014|NCT03174171|"~     The overall objective is to evaluate everolimus as an aldosterone-lowering drug in the~     treatment of primary hyperaldosteronism.~   "
30052|NCT03173677|"~     Macrophages can exhibit distinct phenotypes and functions in response to stimuli and can~     polarize into one of three distinct phenotypes: a pro-inflammatory (M1), an anti-inflammatory~     pro-tissue (M2) and metabolically-activated (MMe) macrophage phenotypes. Thirty-six healthy~     volunteers were recruited and randomized into one of three macronutrient intake groups~     (glucose, lipids, proteins). This study measured the effects of macronutrient intake on the~     macrophage differentiation.~   "
30015|NCT03174158|"~     This study is a four arm pilot randomized controlled trial testing the effect of a 12 week~     text messaging intervention and a mailed nicotine medication intervention, alone and in~     combination to a control condition consisting of brief behavioral advice and usual care.~      Research Aim 1: To test, in a 4 arm pilot randomized controlled trial (N=50/group), the~     effect of a text messaging program and mailed nicotine replacement therapy on smoking~     outcomes and medication use.~      Hypothesis 1: A text messaging intervention will increase the proportion of smokers making a~     quit attempt compared to smokers receiving no text messaging.~      Hypothesis 2: A text messaging intervention will increase adherence to nicotine replacement~     therapy compared to subjects receiving only 2 weeks of nicotine replacement therapy.~      Hypothesis 3: A text messaging intervention will increase the rate of biochemically confirmed~     past 7-day point prevalent tobacco abstinence at end of treatment compared to subjects~     receiving no text messaging intervention.~      Hypothesis 4: A text messaging intervention will increase the number of days not smoking~     compared to subjects receiving no text messaging intervention.~      Hypothesis 5: A text messaging intervention will decrease the number of cigarettes smoked per~     day compared to subjects receiving no text messaging intervention.~   "
30016|NCT03174145|"~     The purpose of this clinical trial conducted in patients suffering from chronic pain is to~     study the relationship between individual patients' profile and their analgesic response~   "
30017|NCT03174132|"~     The purpose of this study is to evaluate the pain and safety in associated with injection of~     Restylane Perlane Lidocaine compared to Restylane Perlane using VAS scale~   "
30018|NCT03174119|"~     In this randomized, double-blind, placebo controlled project, the investigators would like to~     assess the effect of a specific light, as compared to placebo light, on wakefulness~     (circadian rhythms, homeostasy, sleep-wake cycle), awareness (perceptual and self~     consciousness), cognition (attention, memory) and underlying brain activity~     (electrophysiology and neuroimaging)~   "
30019|NCT03174106|"~     Cardiovascular disease is the leading cause of morbidity and mortality globally. Cardiac~     rehabilitation (CR) including exercise training are effective to reduce morbidity, mortality~     and risk factors such as physical fitness, cholesterol, triglycerides and blood pressure. The~     main goal for CR is to establish exercise training and other lifestyle changes as permanent~     changes in the patient's life. Many studies have shown that cardiac patients strive to~     maintain a heart-healthy lifestyle, one year after participating in CR. Furthermore, this~     leads to risk profile returning to the starting point where they got their Cardiac event.~     Changing a lifestyle is known to take time, and we believe that the patients need further~     follow-up beyond the time spent in traditional CR.~      To our knowledge very few, if any, studies evaluates the use of modern technology in longterm~     follow-up focusing on maintaining a new lifestyle after participating in CR. The~     investigators would like to evaluate the effect of an dynamic application (app) with regard~     to physical fitness, lifestyle and quality of life (QoL), one year after CR. The~     investigators hypothesize that patients getting Access to a dynamic Application and tailored~     feedback through the application after CR will better be able to take care of physical~     Fitness and other lifestyle factors one year after CR, compared to patients getting usal~     care.~   "
30020|NCT03174093|"~     This study will assess the benefits of using a mobile health application designed for shared~     decision aid in anticoagulation therapy in patients with Atrial Fibrillation (AF). The aim is~     to improve their treatment adherence and time in therapeutic International Normalized Ratio~     (INR) range. The results of this study have the potential to lead to a sustainable and~     resource-efficient strategy for better prevent thromboembolic events in patients with atrial~     fibrillation.~   "
30021|NCT03174080|"~     Osteoarthritis (Osteoarthritis) of the knee is a high prevalence in the population of people~     aged 60 years and over, when in some cases does not cause any discomfort or pain, and~     therefore not diagnosed. In addition, Radio graphic findings of the knee not fully compatible~     with the patient's symptoms, which resulted in errors in the interpretation and diagnosis.~      In this study, patients who suffer from two knees or unilateral pain, will take part.~     Participants will undergo a clinical examination, including evaluation of symptoms by an~     orthopedist and an X-ray imaging, which are part of the currently accepted medical diagnosis.~      Patients will perform PET-MRI test in order to assess whether PET MRI is a more efficient~     tool for active knee osteoarthritis diagnosis.~   "
30022|NCT03174067|"~     This is a pilot randomized control trial randomizing patients presenting in opioid withdrawal~     to the emergency department to receive either one of clonidine (usual standard of care) or~     buprenorphine for their opioid withdrawal. Primary treatment outcome is attendance at a rapid~     access addiction medicine clinic within a few days of emergency room presentation. Secondary~     treatment outcome is treatment status with respect to opioid agonist treatment at one month~     post emergency room visit.~   "
30023|NCT03174054|"~     Prostate cancer is a common disease in men. In prostate 35% of biopsies, usually done due to~     increased PSA levels or clinical suspicion, are false negative, despite malignancy.~      Multi-parametric prostate MRI detects malignant neoplasm lesions better than other imaging~     devices.~      A sonar-guided prostate biopsy based on multi-parametric MRI images improves detection of~     malignancy. Ga68 PSMA-PET test uses a radioactive marker that binds to the prostate's cells~     and is shown to be a primary prostate tumor site in addition to metastasis.~      We believe that the combination of measures from a single Ga68 PSMA and multi-parametric MRI~     test can lead to further improvement in malignancy, better biopsy guidance, and optimal~     treatment for the patient.~   "
30024|NCT03174041|"~     The purpose of this study is to assess the potential for a drug interaction between GDC-0853~     and midazolam, itraconazole, rosuvastatin, and simvastatin.~   "
30025|NCT03174028|"~     Anorectal malformations are congenital malformations, in which the terminal part of the~     hindgut is abnormally placed and lies outside (partially or completely) the sphincter~     mechanism.~   "
30053|NCT03173664|"~     KAMRA inlay, to be unilaterally implanted into the cornea of a subject's non-dominant eye.~     The inlay is to be inserted into a stromal pocket created with a surgical femtosecond laser.~   "
30054|NCT03173651|"~     60 Patients were randomly allocated into three equal groups, after induction of general~     anesthesia one of the three airways included in the study (Modified Williams, Modified~     Gudle's and LMA MADgic airway) was used as a conduit for endotracheal tube placement using~     fiberoptic bronchoscopy. Airway insertion time, ease of insertion, adaptation to oral cavity~     and intubation time was recorded.~   "
30026|NCT03174015|"~     This intervention will experimentally test the hypothesis that sanitation can be improved in~     a peri-urban setting using state-of-the-art behaviour change communications.~      Formative research indicated that landlords are the effective decision-makers about~     investments in sanitation on their plots (which can include a number of tenant households as~     well). Landlords will therefore be the primary targets of the intervention. The study will~     take the form of a randomized controlled trial of the intervention evaluated at the plot~     level. The intervention will invite enrolled landlords to a series of meetings in which~     various mechanisms will be used, each designed to increase their likelihood of improving the~     toilet(s) on their plot. These meetings will be the main vehicle for a status-building~     campaign associated with increasing wealth by improving plot sanitation, understanding~     tenants' implicit demand, understanding the processes by which toilets can be improved, and a~     competition rewarding landlords that make the greatest improvements to the improvement of~     their toilet(s). The desired improvements will be measured via multiple primary outcomes that~     measure aspects of changes to hardware and software components, including indicators of~     hygienic quality, psychological desirability, accessibility, and ecological sustainability.~     This is because the investigators argue that, to have a significant impact on~     population-level diarrheal disease indicators, any sanitation solution must be:~        -  effective at reducing exposure to pathogens (i.e., hygienic),~        -  desirable (i.e., seen as valuable or humane), and~        -  accessible (i.e., no one excluded), so that it can be used by all~        -  for a reasonably long time (i.e., sustainable)~   "
30027|NCT03174002|"~     Handling oxygenation targets (HOT) is standard of care in the intensive care unit (ICU),~     however the quality and quantity of evidence is low and potential harm has been reported. The~     aim of the HOT-ICU trial is to assess the overall benefits and harms of two levels of~     oxygenation targets in adult critically ill patients with acute hypoxaemic respiratory~     failure in the ICU.~   "
30028|NCT03173989|"~     Introduction: Osteoarthritis is a disabling disease that can affect 6% to 12% of the adult~     population and more than a third of people over 65 years of age. Considering osteoarthritis~     of hands, existing research about the therapeutic treatment advocates actions such as (1)~     joint protection, (2) assistive technology and (3) exercises, however, doubts persist as to~     their effects. Objective: To verify the functional and analgesic effect of joint protection~     and energy conservation techniques, assistive technology (orthotics and adaptations) and~     exercises in the treatment of patients with osteoarthritis of the hands. Method: An~     epidemiological study in which a total sample of patients with knee osteoarthritis will~     receive joint protection and energy conservation guidelines. Subsequently, the sample will be~     divided into two groups, group 1 with radiological signs that suggest osteoarthritis of the~     hands and 2 with patients with radiological signs and symptoms of osteoarthritis of the~     hands, who present greater functional limitations in the daily life, being eligible for~     treatment of Rehabilitation, in which will be used orthosis aiming at the relief of pain,~     stabilization of the affected joints and the prevention of grievance of deformities and~     orientations of exercises to maintain muscle strength. Participants will be followed up for~     two years, evaluated with the Disabilities of the Arm, Shoulder and Hand questionnaire~     (DASH), Stanford Health Assessment Questionnaire (HAQ), palmar grip strength measured with~     Jamar dynamometer, key pinch strength, three point pinch strength and pulp pinch strength~     measured with B & L Pinch-gauge dynamometer. The groups will be divided between 1 and 2, the~     group 1 will be composed of patients who will only perform the orientations informed in the~     theoretical and practical classes, while the group 2, besides the orientations will receive~     orthoses with models such as volar hand rest splints, short thumb stabilization splints, and~     volar finger splints with nocturnal support, aiming at the relief of the pain, stabilization~     of the affected joints and the prevention of the appearance / aggravation of deformities.~     Exercise guidelines for maintenance of muscle strength for thumb and fingers will be~     performed on patients who present significant improvement of pain.~   "
30029|NCT03173976|"~     The purpose of this single arm open label phase 1b clinical study is to see what effect~     zoledronic acid has on tumors in patients with resectable any grade chondrosarcoma prior to~     surgery.~   "
30030|NCT03173963|"~     Background:~      Diabetes is common among American Indian people and diabetic kidney disease is a common~     complication. Kidney disease caused by diabetes can lead to the need for kidney replacement,~     by dialysis or kidney transplant, and is also associated with higher risk of early death. A~     new diabetes medicine called empagliflozin may slow kidney disease from type 2 diabetes.~     Researchers want to learn if it protects the kidneys when used in very early stages of~     diabetic kidney disease.~      Objectives:~      To see if empaglifozin delays kidney disease development.~      Eligibility:~      Adults 18-64 years old who are at least half American Indian and have had type 2 diabetes at~     least 5 years~      Design:~      Participants will be screened with health questions, blood pressure, and blood and urine~     tests.~      Participants will have:~        -  Medical history~        -  Physical exam~        -  Blood, urine, and stool samples taken~        -  Scan of the kidneys and liver. Participants will lie on a table that slides into an MRI~          machine. They will hold their breath for up to 20 seconds and the MRI machine will take~          images of their kidneys and liver. They will then repeat this with a small device that~          vibrates on their side.~        -  Kidney tests. A needle will be placed in a vein in each arm for 4 hours. Blood pressure~          will be taken. Participants will drink several quarts of water and urinate every 20~          minutes. Urine and blood samples will be collected. Two liquids will be injected into~          their veins to measure kidney function.~        -  Photos of the back of the eyes~        -  Kidney biopsy. Participants will have a scan and get drugs to make them sleepy. Up to~          four very small pieces of kidney will be removed by needle. After the biopsy~          participants will be monitored for at least 4 hours.~        -  Nerve tests~      Participants will take the study drug or placebo pill once a day. Participants will attend~     for tests every twelve weeks and have more extensive kidney function tests once a year. After~     3 years, participants will have another kidney biopsy and then stop taking the study drug.~     They will have a final kidney function test 2 months later.~   "
30031|NCT03173950|"~     Background:~      More than 130 primary tumors of the central nervous system (CNS) have been identified. Most~     affect less than 1,000 people in the United States each year. Because these tumors are so~     rare, there are few proven therapies. This study will test whether the immunotherapy drug~     nivolumab is an effective treatment for people with rare CNS tumors.~      Objectives:~      To learn if stimulating the immune system using the drug nivolumab can shrink tumors in~     people with rare CNS (brain or spine) tumors or increase the time it takes for these tumors~     to grow or spread.~      Eligibility:~      Adults whose rare CNS tumor has returned.~      Design:~      Participants will be screened:~        -  Heart and blood tests~        -  Physical and neurological exam~        -  Hepatitis tests~        -  Pregnancy test~        -  MRI. They will lay in a machine that takes pictures.~        -  Tumor tissue sample. This can be from a previous procedure.~      At the start of the study, participants will have blood tests. They will answer questions~     about their symptoms and their quality of life.~      Participants will get nivolumab in a vein every 2 weeks for up to 64 weeks.~      Participants will have monthly blood tests. Every other month they will have an MRI and a~     neurologic function test. They will also answer questions about their quality of life.~      Genetic tests will be done on participants tumor tissue. Participants will be contacted if~     any clinically important results are found.~      After treatment ends, participants will be monitored for up to 5 years. They will have a~     series of MRIs and neurological function tests. They will be asked to report any symptoms~     they experience....~   "
30069|NCT03173456|"~     This study compares the efficacy of five oral analgesics: 5 mg oxycodone + 325 mg~     acetaminophen, 5 mg hydrocodone + 300 mg acetaminophen, 30 mg codeine + 300 mg acetaminophen,~     400 mg ibuprofen + 1000 mg acetaminophen, and 800 mg ibuprofen + 1000 mg acetaminophen for~     the treatment of patients with acute musculoskeletal pain who present to the Emergency~     Department (ED).~   "
30032|NCT03173937|"~     Background:~      Severe aplastic anemia (SAA) and myelodysplastic syndrome (MDS) are bone marrow diseases.~     People with these diseases usually need a bone marrow transplant. Researchers are testing~     ways to make stem cell transplant safer and more effective.~      Objective:~      To test if treating people with SAA or MDS with a co-infusion of blood stem cells from a~     family member and cord blood stem cells from an unrelated donor is safe and effective.~      Eligibility:~      Recipients ages 4-55 with SAA or MDS~      Donors ages 4-75~      Design:~      Recipients will be screened with:~        -  Blood, lung, and heart tests~        -  Bone marrow biopsy~        -  CT scan~      Recipients will have an IV line placed into a vein in the neck. Starting 11 days before the~     transplant they will have several chemotherapy infusions and 1 30-minute radiation dose.~      Recipients will get the donor cells through the IV line. They will stay in the hospital 3-4~     weeks. After discharge, they will have visits:~        -  First 3-4 months: 1-2 times weekly~        -  Then every 6 months for 5 years<TAB>~      Donors will be screened with:~        -  Physical exam~        -  Medical history~        -  Blood tests~      Donors veins will be checked for suitability for stem cell collection. They may need an IV~     line to be placed in a thigh vein.~      Donors will get filgrastim injections daily for 5-7 days. On the last day, they will have~     apheresis: Blood drawn from one arm or leg runs through a machine and into the other arm or~     leg. This may be repeated 2 days or 2-4 weeks later.~   "
30033|NCT03173924|"~     Background:~      Prostate cancer is the second leading cause of cancer deaths in American men. Few options~     exist to create images of this type of cancer. Researchers think an experimental radiotracer~     called 18F-DCFPyL could find sites of cancer in the body.~      Objective:~      To see if 18F-DCFPyL can identify sites of prostate cancer in people with the disease.~      Eligibility:~      People ages 18 and older who have metastatic prostate cancer~      Design:~      Participants will be screened with:~        -  Blood tests~        -  Physical exam~        -  Medical history~      Participants will be assigned to 1 of 2 groups based on their PSA.~      Participants will have 18F-DCFPyL injected into a vein. About 2 hours later they will have a~     whole-body Positron Emission~      Tomography/Computed Tomography (PET/CT). For the scan, they will lie on their back on the~     scanner table while it takes pictures of the body. This lasts about 50 minutes.~      On another day, participants will have 18F -NaF injected into a vein. About 1 hour later,~     they will have a whole-body PET/CT.~      Participants will be contacted 1 3 days later for follow-up. They may undergo PET/Magnetic~     Resonance Imaging (MRI) either after having a 18F-DCFPyL PET/CT, or in place of PET/CT~     imaging. A tube may be placed in the rectum. More coils may be wrapped around the outside of~     the pelvis.~      If the 18F-DCFPyL PET/CT is positive participants will be encouraged to undergo a biopsy of~     one of the tumors. The biopsy will be taken through a needle put through the skin into the~     tumor.~      Participants will be followed for 1 year. During this time researchers will collect~     information about their prostate cancer, such as PSA levels and biopsy results.~      About 4-6 months after scanning is completed, participants may have a tumor biopsy. The~     biopsy will be taken through a needle put through the skin into the tumor.~   "
30034|NCT03173911|"~     Elastic Bandaging Therapy (BET) is a technique that consists of the application of elastic~     adhesive tape directed on a skin, and is used for pain reduction, improvement of flexibility,~     postural alignment. It is believed that it can help proprioception by increasing or reducing~     muscle tension by acting on motor coordination and balance. The present study aims to~     evaluate the effect of the application of different BET strategies on the postural balance of~     healthy young women through measures obtained through a proper instrument for a balance~     assessment, a force platform.~   "
30035|NCT03173898|"~     The literature concerning the success and pain scores of PDL injection technique compared~     with other techniques remains controversial; whereas some studies found no significant~     difference in pain scores between local infiltration and PDL injection, other older studies~     found that pain during administration of PDL injection was described by the majority of~     patients either as greater than local infiltration6, or as negligible or as a less painful~     injection compared with other injection techniques. The aim of this study was to evaluate the~     efficacy of and patients' subjective responses to the PDL injection technique as compared to~     the traditional infiltration injection, for the non-surgical extraction of one posterior~     maxillary permanent tooth.~   "
30036|NCT03173885|"~     This is a two-arm parallel group randomized controlled trial at the Department of~     Reproductive Medicine at Ghent University Hospital. Women >=18 and <37 years of age~     undergoing their first or second IVF/ICSI treatment, with at least 2 good quality blastocysts~     remaining after fresh embryo transfer will be randomized to either transfer of a~     cryopreserved blastocyst selected based on morphology (standard treatment arm) or transfer of~     a cryopreserved blastocyst selected based on PGS and morphology (intervention treatment arm).~   "
30037|NCT03173872|"~     For the past few years, the military has been looking for an innovative way to decrease the~     use of opioids for chronic pain. This has prompted military treatment facilities to begin~     integrating complementary and/or alternative medicine modalities into their conventional~     plans of care. Reiki, a bio-field energy therapy, is one such modality. The purpose of this~     prospective repeated measure study is to: 1) introduce the concept Reiki therapy to military~     healthcare beneficiaries experiencing chronic pain, 2) assess pain outcome after receiving~     six treatments of Reiki therapy, and 3) assess participant's impression of Reiki therapy as a~     possible complementary and/or alternative option for the management of chronic pain.~      Thirty military healthcare beneficiaries with the complaint of chronic pain will receive a~     brief introduction to Reiki therapy followed by six 30-minute Reiki sessions provided by~     trained Reiki Level 1 Practitioner. Participant's knowledge of Reiki will be assessed using~     pre and post questionnaires; pain will be assessed using the Brief Pain Inventory, Defense~     Veterans Pain Rating Scale, DoD (Department of Defense) VA (Veteran's Administration) Pain~     Supplementary Questionnaire, McGill Pain Questionnaire and pain medication diaries; and~     participant's impression will be assessed using the Patient Global Impression of Improvement~     Scale and along with a post study questionnaire. If it is found that Reiki therapy helped in~     decreasing chronic pain outcomes, this treatment modality may be added to Landstuhl Regional~     Medical (LRMC) Pain Clinic's pool of complementary and alternative medicine options.~   "
30038|NCT03173859|"~     A randomized phase II study comparing the sequential use of abiraterone followed after~     progression by apalutamide with alternating cycles of abiraterone and apalutamide~   "
30039|NCT03173846|"~     This study aims to predict cognitive decline using a performance endophenotype of~     neuro-feedback based on functional magnetic resonance imaging in real time in a population at~     risk for Alzheimer's disease (AD).~   "
30146|NCT03172442|"~     This experimental study aims to evaluate the efficiency of the orthodontic removable traction~     appliance in the treatment of skeletal class III malocclusion. The study sample will consist~     of 44 patients with skeletal class III malocclusion. The sample will be allocated randomly~     into two groups: experimental group and control group. The dentoskeletal changes will be~     assessed by using lateral cephalometric radiographs before treatment and after obtaining 3mm~     positive overjet.~   "
30040|NCT03173833|"~     The aim of phase 1 of this study is to develop a care need scale (CNS) for adolescents with~     cancer. The aim of phase 2 is to examine the mediating role of care needs between physical~     and psychosocial dysfunction and QoL, and to explore the recovery trajectory and its~     predictors regarding the care needs, physical and psychosocial factors, and the QoL of~     adolescents with cancer at the first, second, and third 3-month periods after initiating~     on-treatment and off-treatment. The aim of phase 3 is to examine the effectiveness of the~     computerized assessment with graphic outcome (CAGO) for fulfilling the care needs of~     adolescents with cancer, its acceptability for adolescents with cancer, and its usability for~     clinicians in pediatric oncology units.~   "
30041|NCT03173820|"~     Kidney transplantation is the most appropriated treatment in end stage renal failure patients~     in order to improve quality of life. However, patients have to take immunosuppressive drugs~     to prevent graft rejection. Tacrolimus is the most common immunosuppressive drug used now.~     However, tacrolimus has narrow therapeutic level and needs regularly therapeutic monitor~     because of inter-individual variation in dosage regimen. Not only age, body weight and drug~     interaction but also genetic factor in metabolic pathway of tacrolimus plays an important~     role in tacrolimus blood level. Previous data showed CYP3A5 genetic polymorphism was~     significant effect tacrolimus blood level. From previous study showed the mean dose of~     tacrolimus required for the induction phase was significantly higher (P= 0.006) in the~     CYP3A5*1/*1 group at 0.142±0.050 mg/kg/day than that required by patients who carried either~     the CYP3A5*1/*3 group of 0.097±0.040 mg/kg/day or the CYP3A5*3/*3 group of 0.077±0.020~     mg/kg/day. Tacrolimus maintenance dose required for CYP3A5*1/*1 group of 0.12±0.03 mg/kg/day~     was 1.3 times higher (P<0.0001) than used for the CYP3A5*1/*3 at 0.09±0.03 mg/kg/day and 2.4~     times higher than the CYP3A5*3/*3 group of 0.05±0.02 mg/kg/day. Therefore, the investigators~     plan to investigate a prospective study to determine the clinical outcome of tacrolimus~     treatment in kidney transplant recipients between genotype guided dosage regimen group and~     conventional group.~   "
30042|NCT03173807|"~     The purpose of this study is to test the feasibility of nutrition and exercise counseling~     program for reducing the incidence of metabolic syndrome in prostate cancer patients on~     Androgen Deprivation Therapy.~   "
30043|NCT03173794|"~     The goal of this research program is to reduce health disparities by deploying an~     information-based intervention to increase caregiver utilization of community-based food~     supports and satisfaction with care among food insecure caregivers of hospitalized children.~     We will conduct a randomized controlled trial to evaluate, versus usual care, the effects of~     the CommunityRx-H intervention on caregiver use of food resources (primary), caregiver~     patient satisfaction with care (primary), caregiver mental health-related quality of life~     (secondary), and caregiver household food security (secondary). The proposed research will~     yield an understanding of how to leverage a child's hospitalization to effectively intervene~     on the problem of food insecurity. Findings will inform the rapidly growing field of~     healthcare-based interventions to address health-related social needs.~   "
30044|NCT03173781|"~     The purpose of this study is to determine if droxidopa reduces fall risk by improving gait~     speed, kyphosis, and functional reach in individuals with Parkinson's disease.~   "
30045|NCT03173768|"~     A quasi-experimental study was conducted among patients receiving care at the medicine units~     of the Maharaj Nakorn Chiang Mai Hospital to determine the appropriateness of intravenous~     antibiotics at hospital discharge with and without ID consultation.~   "
30046|NCT03173755|"~     In order to better understand how pre-existing pain and also discomfort/enjoyment during~     exercise may influence physical activity and be related to body weight the investigators are~     seeking to examine these as they relate to overweight/obesity compared to normal weight~     individuals. Ultimately, the investigators think that people with obesity may have more and~     be more sensitive to pain and have lower discomfort tolerance that may lead them to~     experience exercise more negatively. In the real world, this could result in them stopping~     exercise sooner or avoiding exercise all together. Therefore it is important for the~     investigators to begin to understand this issue better. In addition, some preliminary studies~     in animals suggest that the quality of the diet may influence pain sensitivity. This has yet~     to be examined in humans. As such the investigators will examine whether self-reported diet~     quality and also some markers in participants' blood that can tell the investigators about~     the recent quality of a person's diet, are related to the measures of pain, enjoyment and~     discomfort during exercise.~   "
30047|NCT03173742|"~     Evaluation of the bioavailability and safety of one oral preparation containing fixed dose 18~     mg ivermectin (IVM 18 MG TABLETS, LICONSA S.A., Spain) or two oral preparations containing~     fixed dose 18 mg ivermectin (IVM 36 MG TABLETS, LICONSA S.A., Spain) vs. reference dosing~     (weight based) of reference drug containing 6 mg ivermectin (REVECTINA®, Abbott Laboratórios~     do Brasil Ltda, Brazil) in fasting conditions. A monocentric, open, randomized, single dose,~     three-period crossover trial in healthy volunteers.~   "
30048|NCT03173729|"~     This is a-two phase study. Phase 1 will adapt a 3-metabolite biosensor that identifies~     patients with colorectal cancer (CRC) and precancerous polyps to Nigerian patients. Phase 2~     will pilot test and evaluate the point-of-care (POC) biosensor device in Nigeria.~   "
30049|NCT03173716|"~     This study is being done to find out if and how much the use of RTMPE improves a provider's~     confidence in the diagnosis they assign. This is important because the use of RTMPE may~     decrease the need for any additional invasive testing.~   "
30050|NCT03173703|"~     The purpose of this trial is to collect safety and effectiveness data to support peripheral~     vascular indication of XenoSure biologic patch. This trial is performed to meet the China FDA~     regulation in this kind of device. The clinical trial will be performed solely inside China~     under GCP regulation and all applicable China regulations on medical device clinical trial.~   "
30051|NCT03173690|"~     This study evaluates the effect of performing medicines reconciliation on patients admitted~     to an intensive care unit. Half of the patients will receive a medicines reconciliation at~     the intensive care unit. The other half will not. All included patients will receive~     medicines reconciliation after transfer to the ward.~   "
30232|NCT03171324|"~     Term infants (Small for Gestational Age and Appropriate for Gestational Age) would be~     randomized to receive oral iron supplementation from 6 weeks and 6 months. Growth in terms of~     Occipitofrontal circumference, length and weight would be monitored at 6 weeks, 6 months and~     1 year of age. Hemoglobin, RBC (Red blood corpuscles) indices and ferritin would be monitored~     at 6 months and 1 year of age.~   "
30055|NCT03173638|"~     In this study the investigators propose to perform a Phase II Clinical Trial which seeks to~     evaluate the safety of cell therapy as a new treatment for patients who suffer from acute~     non-arteritic anterior ischemic optic neuropathy (NAION). If it is successful, a later study~     to assess efficacy will be performed.~      This disease has an age-adjusted incidence rate of 10/100.000, and in many cases it results~     in blindness. Currently, there is no available treatment and second eye involvement occurs in~     approximately 15-25% of the cases.~      All this background originates a particularly dramatic outcome for the patient. Therefore, it~     seems justified to evaluate new therapies that maintain or improve the visual function in~     these patients.~      The Project includes a clinical trial whose purpose is the assessment of the safety of~     intravitreal administration of allogenic mesenchymal stem cells (MSC) in patients with NAION,~     a product in clinical research phase (PEI No. 15-007) already approved for other human~     clinical applications (PEI No. 15-007).~      It can be considered that the therapy with intravitreal injection of MSC is a treatment~     option in patients with acute NAION, since through the paracrine properties of these cells~     (secretion of neurotrophic, immunomodulatory and anti-apoptotic factors) it may prevent or~     reduce the progression of axonal degeneration caused by this disease.~   "
30056|NCT03173625|"~     The main objective of the study is to investigate the safety and tolerability of single~     ascending doses of AC-076 administered as subcutaneous injection~   "
30057|NCT03173612|"~     The purpose of this study is to evaluate that whether the AML (acute myeloid leukemia)-CAMS~     (Chinese Academy of Medical Sciences)-2016 regimen, includes risk-stratified therapy and the~     use of Dasatinib in CBF (Core binding factor)-AML, can improve the outcome in childhood AML.~   "
30058|NCT03173599|"~     A Safety and Tolerability Evaluation of Ascending Single Oral Doses of Metacavir~     Enteric-coated Capsules Using a Randomized，Double-blind, Placebo-controlled Design conducted~     in Chinese Healthy Adult Volunteers.~   "
30059|NCT03173586|"~     This study is a secondary analysis of data collected in the Nurses' Health Study (NHS) that~     will evaluat the association between intake of sugar sweetened beverages (SSB), juice and~     artificially sweetened beverages in relation to biomarkers of hepatic function, lipid~     metabolism, inflammation and glycemic control.~   "
30060|NCT03173573|"~     This is a 5-part study of FDL176. Part 1 is a double blind, placebo-controlled, dose~     escalation study in healthy male participants. Part 2 is a single dose, open-label study in~     healthy male participants. Part 3 is a single dose, double blind, placebo-controlled study in~     healthy female participants. Part 4 is a randomised, double-blind, placebo-controlled,~     dose-escalation study in healthy male and female participants.Part 5 is a single dose,~     open-label study in male and female participants with CF.~   "
30061|NCT03173560|"~     Study E7080-G000-218 is a Randomized, Double-blind, Phase 2 Trial conducted to assess whether~     a starting dose of lenvatinib 14 milligrams (mg) in combination with everolimus 5 mg once~     daily (QD) will provide comparable efficacy (based on objective response rate [ORR] at 24~     weeks [ORR24W]) with an improved safety profile compared to lenvatinib 18 mg in combination~     with everolimus 5 mg (based on treatment-emergent intolerable Grade 2, or any ≥ Grade 3~     adverse events (AEs) in the first 24 weeks after randomization).~   "
30062|NCT03173547|"~     The objective of this study is to determine and compare the safety and efficacy of topical~     146-9251 cream and vehicle cream applied twice daily for 6 weeks in subjects with moderate to~     severe ichthyosis vulgaris (IV).~   "
30063|NCT03173534|"~     To evaluate the safety and effectiveness of the left atrial appendage occlusion with WATCHMAN~     Device in prevention of stroke and bleeding in patients with atrial fibrillation (AF)~     undergoing transcatheter aortic valve replacement (TAVR).~   "
30064|NCT03173521|"~     This study investigated the safety and efficacy of gene therapy approaches for~     Mucopolysaccharidosis type VI disease caused by the deficiency of arylsulfatase B (ARSB)~     enzyme. The aim of the study is to evaluate the safety and efficacy of the treatment.~   "
30065|NCT03173508|"~     This trial will evaluate the effect of acetazolamide (375 mg per day) vs. placebo on right~     ventricular function at acute altitude exposure in patients with COPD.~   "
30066|NCT03173495|"~     Cardiovascular Diseases (CVDs) are the leading causes of death in the world and in Brazil. In~     2001, 12.45 million deaths on the globe (21% of the total) were caused by some CVD.~      The composition of modern man's diet has changed drastically with the industrialization of~     food, resulting in the transition from a diet rich in fibers and complex carbohydrates to one~     with a high content of sugars and fats. Since the current dietary pattern is characterized by~     the consumption of three or more meals a day, containing a quantity of fat in the range of 20~     to 70 g, individuals spend a large part of the day in the postprandial state, with continuous~     fluctuation of lipemia Over 18 hours. Food intake (postprandial state) is the dynamic,~     unstable response of the body that refers to rapid hormonal and lipoprotein remodeling. It is~     well established in the literature that high-fat meals (lipid overload) cause an increase in~     plasma triglycerides. Hypertriglyceridemia and / or elevated triglyceride-rich lipoproteins~     (LRT) (chylomicrons, VLDL and their remnants) in the postprandial state induces endothelial~     dysfunction via increased oxidative stress and is an independent risk factor for CVDs.~     Therefore, Postprandial Lipemia (PPL) is counted as an early marker of atherosclerotic~     process, metabolic abnormalities and endothelial dysfunction.~      High-carbohydrate (CHO) diets may promote increased LDL-c, TG, VLDL and HDL-c reduction, as~     well as PPL, generating a lipid profile associated with an increased risk of CVDs. This~     effect appears to be more pronounced with the inclusion of simple carbohydrates (mono and~     disaccharides), although it also occurs with diets rich in complex carbohydrates~     (polysaccharides).~      High fructose diets (HFDs) are a known model of induction of insulin resistance, dyslipidemia~     and DM2 in primates and humans. The chronic effect of fructose consumption has been well~     studied in the last decades due to its connection with obesity, resistance to Insulin,~     accumulation of visceral fat and dyslipidemia.~      As the consumption of fructose is progressively increasing in society and its chronic~     exposure can generate a phenotypic effect of dyslipidemia and, consequently, the increased~     risk of CVDs, prevention and treatment strategies should be seen as an important public~     health issue . Thus, the objective of this study is to understand the effects of exercise on~     fat metabolism, since there is a lack of robust evidence about the possible cardioprotective~     and hypolipemic role of the same on HFD.~   "
30067|NCT03173482|"~     Cesarean section on demand: defined as a primary cesarean section performed at the mother's~     request to avoid a vaginal birth, without any recognized medical or obstetric indication. The~     medical field now acknowledges a patient's right to actively participate in her choice of~     medical treatments, including method of delivery.~      There are many reasons for a cesarean section on demand: fear of delivery, fear of pain,~     family pressure, a previous bad experience, more control over events, improved care, and~     maintaining the integrity of the pelvic floor. of the pelvic floor.~   "
30068|NCT03173469|"~     all female with operable breast cancer seeking health care at general surgery department~     Assiut university hospitals,and decision of therapeutic mammoplasty was taken depending on~     clinical examination, findings on mammography and sonography, will undergo MRI breast, and~     see if MRI finding will change decision of the surgery.~   "
30070|NCT03173443|"~     One lung ventilation (OLV) is required during thoracic procedures such as lung and esophagus~     surgery. three technique can be employed. (1) placement of a double-lumen bronchial tube~     (DLT); (2) use of a single-lumen tracheal tube (SLT) in conjunction with a bronchial blocker;~     (3) insertion of a conventional SLT into a main bronchus. Flexible fiberoptic intubation with~     SLT is well established technique for anticipated or unexpected difficult intubation. But,~     little is known about flexible fiberoptic intubation with DLT.~      The investigators compared insertion time over fiberoptic bronchoscope between SLT with~     bronchial blocker and DLT in patients undergoing thoracic surgery.~   "
30071|NCT03173430|"~     This study involves receiving blinatumomab after high-dose melphalan and ASCT for multiple~     myeloma. The main purpose of this study is to: - To determine whether blinatumomab is safe~     and feasible to administer after ASCT in patients with advanced multiple myeloma. - To assess~     how long multiple myeloma remains under control when blinatumomab is administered after~     second ASCT.~   "
30072|NCT03173417|"~     Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD19~     Chimeric Antigen Receptor to Patients With CD19+ B-cell leukemia.~   "
30073|NCT03173404|"~     This is a prospective randomized open-label trial. Women scheduled for their first or second~     in-vitro fertilization/intracytoplasmatic Sperm Injection (IVF/ICSI) cycle and with no~     abnormality detected in transvaginal ultrasound examination, were randomized to two groups.~     In the first group (group I) 31 patients underwent hysteroscopy examination before IVF cycle~     while in the second group (group II) 37 patients underwent direct cycle without previous~     hysteroscopy~   "
30074|NCT03173391|"~     This study evaluates the efficacy and safety and population PK of HMS5552 as monotherapy in~     type 2 diabetic adult subjects, there will be 2 groups in the first 24 weeks, one group will~     receive HMS5552 , while the other group will receive placebo ; after 24 weeks, all subjects~     received HMS5552 for 28 weeks.~   "
30075|NCT03173378|"~     Narcolepsy is a chronic, disabling condition characterized by excessive daytime sleepiness~     and, in some patients, falls in muscle tone related to emotions (cataplexies). It often~     begins in childhood or in young adults. Symptoms of narcolepsy are responsible for an~     important handicap in everyday life, and are often misunderstood by the family and~     professional environment. In addition, many comorbidities are associated with narcolepsy,~     such as depression, anxiety, or obesity.~      Few studies have examined the impact of narcolepsy on patients' educational background,~     socio-professional integration, and quality of life. In particular, the factors of~     professional handicap related to the characteristics of the disease and the determinants of~     the insertion of the patients remain poorly known.~      As a better understanding of these determinants could help to inform patients and guide them~     in their choices, NARCOWORK study aims at evaluating the academic and professional~     trajectories of a wide population of narcoleptic patients.~   "
30076|NCT03173365|"~     Comparative analysis of the severity of Hand-Foot-Syndrome (HFS) of palms treated with~     brimonidine tartrate gel or with standard care Urea 10% containing lotion in cancer patients~     receiving antineoplastic therapy to show a preventive effect of cutaneous brimonidine~     treatment on severity of HFS symptoms.~   "
30077|NCT03173352|"~     Infant hemangioma(IH) is the most common benign vascular tumor of infancy with the estimated~     incidence varies 1% to 12%.However, in China, the incidence of infant hemangioma and related~     epidemiological data remains unclear. So, the investigators designed the study for the~     following purposes: 1, to aware the incidence of infantile hemangioma and understand the~     related risk factorsin China; 2, to understand the clinical characteristics of infantile~     hemangioma and the risk factors for complications; 3, to investigate the level of knowledge,~     treatment options in infant hemangioma in Chinese doctors; 3, to improve the awareness of~     infantile hemangioma in parents and provide more advice for pregnancy counseling and~     eugenics.~   "
30078|NCT03173339|"~     This investigation is planned to compare the incidence and severity of postoperative sore~     throat according to the dose of remifentanil.~   "
30079|NCT03173326|"~     The study evaluates the efficacy of two different anesthetic techniques in patients~     undergoing unilateral knee arthroscopy. Participants will be randomized to receive either~     subarachnoid block with 2-chloroprocaine or general anesthesia plus intravenous fentanyl.~   "
30080|NCT03173313|"~     The objective of this trial is to evaluate the safety and effectiveness of therapeutic~     hypothermia, using the ZOLL Proteus IVTM System, as an adjunctive therapy for patients~     presenting with acute anterior myocardial infarction (AMI) and undergoing percutaneous~     coronary intervention (PCI).~   "
30081|NCT03173300|"~     Clinical and Basic Investigations into Phosphomannomutase deficiency (PMM2-CDG)~      This is a natural history (observational) protocol designed to collect clinical and~     biological information in patients with PMM2-CDG (CDG-Ia).~      Data from this natural history study will be used to determine a set of clinical and~     biological parameters that will be used for primary and secondary endpoints in a later~     clinical trial with a new chemical entity, Lipo-M1P.~   "
30082|NCT03173287|"~     Quantification of hepatic fibrosis by IVIM sequences in 1.5T MRI.~   "
30083|NCT03173274|"~     The purpose of this study is to investigate the feasibility of a mobile-phone based~     contingency management (CM) intervention for smoking in low-SES women. The CM intervention~     will be combined with a Brief Motivational Interviewing (BMI) counseling component. This~     study will examine the following research aims:~      Primary Aim: To compare the effects of a Brief Motivational Intervention (BMI) + mobile~     phone-based CM on tobacco use when compared to BMI with a non-contingent control condition in~     a small feasibility trial.~      Hypothesis: The investigators expect women in the BMI + CM condition to have more smoke free~     days than women in the BMI + NC condition.~      Secondary Aim: To examine alcohol use as a moderator of cessation outcomes.~   "
30094|NCT03173131|"~     This is a randomized controlled study that will involve fellowship-trained board certified~     orthopaedic surgeons in four different subspecialties (hand surgery, sports surgery, shoulder~     and elbow surgery, and foot and ankle surgery) within our practice group. Consenting patients~     will be randomized to the treatment group (receiving preoperative counseling) or to the~     control group (no preoperative counseling). The control limb will provide us with information~     regarding average opioid consumption following common outpatient orthopedic procedures, and~     the study limb will allow us to evaluate the effect of the pre-operative opioid counseling.~   "
30084|NCT03173261|"~     Diagnosis of extra pulmonary tuberculosis remains especially challenging since the number of~     Mycobacterium tuberculosis bacilli present in tissues at sites of disease is often low and~     clinical specimens from deep-seated organs may be difficult to obtain. Histology is~     time-consuming to undertake and establishing a diagnosis of tuberculosis with high~     specificity remains difficult. Tissue microscopy after special staining is often negative and~     when mycobacteria are seen, it is impossible to distinguish Mycobacterium tuberculosis from~     non tuberculous mycobacterial disease. Reliance on culture, the mainstay of diagnosis, often~     leads to considerable delays, compromising patient care and outcomes.~      Evidence from 138 studies published before 2008 suggested that nucleic acid amplification~     technologies could not replace conventional mycobacterial tests (microscopy, culture) for~     diagnosing pulmonary and, especially, extra pulmonary tuberculosis~   "
30085|NCT03173248|"~     Study AG120-C-009 is a global, Phase 3, multicenter, double-blind, randomized,~     placebo-controlled clinical trial to evaluate the efficacy and safety of AG-120 (ivosidenib)~     + azacitidine vs placebo + azacitidine in adult subjects with previously untreated IDH1m AML~     who are considered appropriate candidates for non-intensive therapy. The primary endpoint is~     Overall Survival (OS). The key secondary efficacy endpoints are Event free Survival (EFS),~     rate of complete remission (CR), Rate of CR and complete remission with partial hematologic~     recovery (CRh), and overall response rate (ORR). Subjects eligible for study treatment based~     on Screening assessments will be randomized 1:1 to receive oral AG-120 or matched placebo,~     both administered in combination with subcutaneous (SC) or intravenous (IV) azacitidine. An~     estimated 392 subjects will participate in the study.~   "
30086|NCT03173235|"~     1,25-dihydroxy-vitamin D3 (1,25 (OH) 2D3) or calcitriol regulates plasma calcium and~     phosphate concentrations in the blood by stimulating intestinal absorption and renal~     reabsorption of calcium and phosphate. 1.25 (OH) 2D3 is formed by the renal 1α25OH vitamin~     D-hydroxylase (Cyp27b1) and inactivated by the renal 25-hydroxy vitamin D-24-hydroxylase~     (Cyp24). Unpublished studies in mice revealed an inhibitory effect of 1.25 (OH) 2D3 on embryo~     implanation. An excess of 1.25 (OH) 2D3 could therefore lead to female infertility. The~     excess of 1.25 (OH) 2D3 could result from uncritical vitamin D intake with insufficient~     negative feedback by FGF23 / Klotho. The aim of the study is to identify patients with an~     excess of 1.25 (OH) 2D3.~   "
30087|NCT03173222|"~     This study aims to prove the efficacy of electroacupuncture (EA) for pain relief in patients~     with acute pancreatitis compared with conventional treatment. Patients diagnosed with acute~     pancreatitis will be enrolled after obtaining informed consents. They will be randomly~     assigned to EA 1, EA 2, or control group in a 1:1:1 ratio. All the enrolled patients will~     basically receive the conventional standard-of-care therapy for acute pancreatitis. Local~     electroacupuncture will be given in group EA 1, while local with distal electroacupuncture~     will be given in group EA 2, additionally. For the conventional therapy, first non-steroidal~     anti-inflammatory drugs will be administered; afterwards, if inadequately controlled,~     low-potency narcotic analgesics such as codeine and then high-potency narcotic analgesics~     such as morphine or meperidine will be given sequentially as required. The patients~     randomized to the EA 1 and 2 groups will undergo 1 session of electroacupuncture daily from~     day 1 until day 4, or until pain is resolved. The primary endpoint is the visual analogue~     scale (VAS) for pain on day 5. Secondary endpoints include daily VAS, requirement of~     analgesics, changes of inflammatory markers, and hospital days.~   "
30088|NCT03173209|"~     We explored the meaning and outcomes of a 4-month program designed to build capacity of~     school personnel in implementing evidence-based strategies for reducing stress and promoting~     mental well-being among students in school settings. A one-group (N 93) mixed-methods design~     using a pretest-posttest survey and qualitative analysis of their written reactions was used~     to explore the meaning and outcomes of the Calm Moments Cards program.~   "
30089|NCT03173196|"~     The patients of the group sepsis are measured several times with the non-invasive~     multi-spectral sonography (Sonovum ACG-Diagnosesystem) (days 1, 3, 7 and 14). The patients~     of the group control are measured on days 1 and 3 with the system. A measurement takes 3~     minutes. For this purpose two ultrasound heads are placed above the patient's ears and fixed~     with an all-head harness. The device is certified for CE application. There are no known~     health risks of ultrasound in humans.~   "
30090|NCT03173183|"~     This is a randomized double-blind placebo controlled trial aim to compare the efficiency of~     genuine regional and non-genuine regional Rhizoma Atractylodis in treating functional~     dyspepsia. This study will also observe the clinical safety of genuine regional Rhizoma~     Atractylodis.The trial will be conducted in Xiyuan Hospital of China Academy of Chinese~     Medicine Sciences and Dongzhimen Hospital of Beijing University of Chinese Medicine.~   "
30091|NCT03173170|"~     The purpose of this study is to evaluate the effect of the potent CYP3A4 inhibitor~     itraconazole on the single-dose PK of TAK-954.~   "
30092|NCT03173157|"~     The investigators hypothesize that a combined didactic and data feedback program presenting~     evidence based indications and in-hospital-charges for echocardiograms to inpatient~     cardiology team members will lead to increased health care value for patients on inpatient~     cardiology teams.~   "
30093|NCT03173144|"~     Chronic inflammatory diseases (CID) - including inflammatory bowel diseases (Crohn's disease~     and ulcerative colitis), rheumatic conditions (rheumatoid arthritis, axial spondyloarthritis,~     psoriatic arthritis), inflammatory skin diseases (psoriasis, hidradenitis suppurativa) and~     non-infectious uveitis are treated with biologics targeting the pro-inflammatory molecule~     tumour necrosis factor-α (TNF), i.e. TNF inhibitors. Up to one third of the patients do,~     however, not respond to biologics and lifestyle is assumed to affect the treatment outcome.~     However, little is known on the effects of lifestyle as a prognostic factor (possibly~     enabling personalised medicine). The aims of this multidisciplinary collaboration are to~     identify lifestyle factors that support individualised forecasting of optimised treatment~     outcome on these costly drugs.~      This prospective cohort study will enrol CID patients assigned for biologic treatment. At~     baseline (Pre-treatment), patient characteristics are assessed using patient-reported outcome~     measures and clinical assessments on disease activity, quality of life, and lifestyle~     together with registry data on comorbidity and medication. Follow-up will be conducted at~     week 14-16 after treatment initiation (according to the current Danish standards). Evaluation~     of a successful treatment outcome response will - for each disease - be based on most~     frequently used primary endpoints; the major outcome of the analyses will be to detect~     differences in treatment outcome between patients with specific lifestyle characteristics.~      The overarching goal of this project is to improve the lives of patients suffering from CID,~     by providing evidence to support dietary recommendations likely to improve the clinical~     outcome.~      The study is approved by the local Ethics Committee (S-20160124) and the local Data Agency~     (2008-58-035). The study findings will be disseminated in peer-reviewed journals, via patient~     associations, and presented at national and international conferences.~   "
30095|NCT03173118|"~     Chronic pancreatitis is a progressive inflammatory condition where progressive fibrosis and~     calcification results in loss of physiological pancreatic function (both endocrine and~     exocrine). The structural, fibrotic changes of chronic pancreatitis can only be seen in~     advanced disease with conventional radiology tests and the diagnosis of chronic pancreatitis~     early in the disease course remains challenging. Early diagnosis and treatment of chronic~     pancreatitis can prevent the complications of pain and malnutrition and improve the quality~     of life of patients. Endoscopic ultrasound (EUS) has recently become a favoured method for~     diagnosing early structural fibrotic changes of chronic pancreatitis in clinical practice;~     however this technique is subjective with sub-optimal intra-observer agreement. A new~     technique called elastography, performed during EUS, quantitatively measures tissue stiffness~     which may give more reliable results. This study aims to assess whether EUS elastography can~     accurately identify for chronic pancreatitis.~      Patients referred for EUS examinations will be identified and recruited prospectively. The~     investigators will perform endoscopic ultrasound examinations with elastography readings in~     two groups of patients: those referred for EUS with suspicion of chronic pancreatitis and~     those referred for EUS for assessment of abdominal pain without risk factors or any other~     tests suggesting chronic pancreatitis. The elastography readings will then be compared to the~     gold standard which is a composite evaluation including standard EUS examination using~     morphological appearance (Rosemont classification), and other tests already performed~     including cross-sectional imaging (MRCP and CT), patient history and faecal pancreatic~     elastase (FEL-1).~      Patients will be identified and data collected prospectively. There is no randomization or~     blinding involved in the study as the endoscopists will need to be aware of the indication~     for referral in order to carry out a complete examination.~   "
30096|NCT03173105|"~     Postural control requires the integration of the vestibular, visual and somatosensory~     systems. Vision, in particular, exerts a considerable influence on body sway during~     activities that require balance. The investigators aimed to analyze the effects of~     transcranial direct current stimulation (tDCS) combined with proprioceptive exercises on~     postural control in individuals between 18 and 55 years old, with congenital and acquired~     blindness.~      Intervention will occur in three phases: 1 - Determine differences in postural control and~     gait between individuals with congenital and acquired blindness with and without the use of a~     guide stick when wearing shoes and when barefoot; 2 - Analyze the effect of anodal tDCS over~     three areas of the brain (primary motor cortex, somatosensory cortex and visual cortex) on~     postural control and gait; 3 - A treatment protocol will be conducted in which the~     participants will be allocated to four groups: G1 - active tDCS + dynamic proprioceptive~     exercises; G2 - sham tDCS + dynamic proprioceptive exercises; G3 - active tDCS + static~     proprioceptive exercises; and G4 - sham tDCS + static proprioceptive exercises.~      Evaluations will involve a camera system for three-dimensional gait analysis, a force plate~     to measure the postural control, and electromyography to analyze the muscles activities.~     Dynamic stability will be determined using the Timed Up and Go test and static stability will~     be analyzed with the aid of the force plate.~      The viability of this study will allow the determination of differences in postural control~     between individuals with congenital and acquired blindness, the analysis of the effect of~     tDCS on postural control and the establishment of a rehabilitation protocol.~   "
30097|NCT03173092|"~     The purpose of this study is to determine the progression-free survival (PFS) at 2 years for~     MM participants previously receiving a bortezomib-based induction regimen to IRD.~   "
30098|NCT03173079|"~     A geriatric assessment is becoming increasingly important in the treatment of patients with a~     percutaneous aortic valve replacement due to their comorbidities. The aim of this multimodal~     therapy concept is to examine the influence on the postoperative outcome. In addition to a~     comprehensive assessment of the individual frailty score, the subjective condition before and~     after TAVI is also evaluated using a standardized questionnaire (Minnesota living with heart~     failure questionnaire).~   "
30099|NCT03173066|"~     This proposal is based on findings from our previous work involving ferumoxytol-enhanced~     cardiac magnetic resonance angiography. The resolution of the pulmonary vasculature based on~     our previous imaging protocol was exceptional (PMID: 26786296). In the Partners Healthcare~     System between January 1, 2014 and January 1, 2015 there were 541 patients evaluated in~     Partners Healthcare-affiliated hospitals with a diagnosis of pulmonary embolism and acute or~     chronic kidney disease at the same visit between 01/01/2014 and 01/01/2015. Ventilation~     perfusion scanning was performed in 201 patients during this same time interval. Up to 63% of~     these patients in one year did not receive the diagnostic test of choice.~   "
30100|NCT03173053|"~     This trial focusses on identifying the most effective and safe long-term S. aureus carriage~     decolonization strategy in home parenteral nutrition patients. Half of the participants will~     receive a quick and short systemic antibiotic treatment combined with topical treatment,~     while the other half will receive only topical treatment on a periodic basis.~   "
30101|NCT03173040|"~     Rheumatoid arthritis (RA) is a chronic, systemic, inflammatory autoimmune disease that~     results in the destruction of joints, connective tissues, muscle, tendons and fibrous tissue.~     Effective therapy to manage RA still does not exit at present. Jia Wei Niu Bang Zi pill~     (NBZP) consists of Chinese herbals which has been widely used in the treatment of RA patients~     in China for hundreds of years to relieve pain and prevent the affected joints pejorative.~     However, there is no systematic trials to prove the effect of NBZP for management of RA.~   "
30102|NCT03173027|"~     Knee osteoarthritis (KOA) is known as degenerative joint disease, which is the most common~     form of arthritis and the leading cause of disability, loss of function and pain worldwide.~     Effective therapy to manage RA is still lack at present. Fangji Huangqi pill (FHP) is a~     Chinese medicine which has been widely used in treating KOA in China for hundreds of years to~     relieve pain, reduce swelling and protect the affected joints from further degeneration.~     However, no certain evidence to show the effect of FHP for the management of active KOA.~   "
30103|NCT03173014|"~     EEG in moyamoya disease in children preoperatively~   "
30104|NCT03173001|"~     Colorectal cancer (CRC) has the third highest cancer incidence in the world. There is~     mounting evidence that the intestinal microbiota plays an important role in colorectal~     carcinogenesis. but there is no information on protozoa of intestinal microbiota except~     Blastocystis hominis, although data on this issue is scarce. In this study we are going to~     evaluate the prevalence of intestinal helminthes and protozoa in CRC patients and control~     group that includes random residents. Patients will be examined before, after surgery and~     chemotherapy. Parasites and protozoan infection intensity will be estimated by triple~     coproscopy.~   "
30134|NCT03172598|"~     A Study to Investigate the Safety, Tolerability and Efficacy of Multiple Doses of MT-8554 in~     Subjects with Painful Diabetic Peripheral Neuropathy~   "
30135|NCT03172585|"~     High resolution computed tomography of the chest is the gold standard imaging modality for~     most pulmonary diseases. However, the associated high expenses, radiation exposure , and its~     limited possibility for bedside use are a limitation.~   "
30105|NCT03172988|"~     Surgical resection is the first choice treatment for patients with non-small-cell lung~     cancer. Despite of advances in surgical techniques, the long-term survival rate of~     postoperative patient is far from optimal. In a recent retrospective cohort study of the~     applicants, 588 patients after surgery for non-small-cell lung cancer were followed up for a~     medium of 5.2 years. The results showed that perioperative use of dexamethasone was~     associated with prolonged survival; perioperative use of flurbiprofen axetil was also~     associated with a slightly longer survival but not statistically significant. Further~     analysis showed that combined administration of dexamethasone and flurbiprofen axetil had~     additive effect in prolonging survival. We hypothesize that, for patients undergoing surgery~     for non-small-cell lung cancer, perioperative administration of dexamethasone and~     flurbiprofen axetil may improve long-term survival. However, evidences from randomized~     controlled trials are still lacking in this aspect.~   "
30106|NCT03172975|"~     This study evaluates the efficacy, safety and immunogenicity of different formulations of the~     Na-GST-1 hookworm vaccine using a controlled human hookworm infection model in healthy,~     hookworm-naive adults.~   "
30107|NCT03172962|"~     Low back pain (LBP) is common in the population and has great socioeconomic consequences for~     societies across Europe and the United States. About a third of working-age adults have~     frequent LBP, and for about 10% the pain becomes chronic with consequences for work and~     leisure activities. A Cochrane review from April 2017 concluded that physical exercise is an~     intervention with few adverse events and positive outcomes on pain and function in adults~     with chronic pain. However, when scrutinizing the specific studies of the review there are~     large differences in adherence to the exercise interventions and consequently in the results~     obtained. Thus, there is a need for simple exercises that the patients can easily adhere to.~   "
30108|NCT03172936|"~     The purpose of this study is to characterize the safety, tolerability, pharmacokinetics,~     pharmacodynamics and antitumor activity of MIW815 (ADU-S100) in combination with PDR001.~   "
30109|NCT03172923|"~     The investigators therefore propose to undertake a further randomised controlled trial~     comparing the sliding hip screw (SHS) with the Targon PFT intramedullary nail. The aim is to~     see if the summation of the first trial of 600 participants comparing the sliding hip screw~     with the Targon PF nails, in conjunction with this study of 400 participants with the updated~     Targon PFT nail produces results that convincingly demonstrate that this particular design of~     implant is superior to the sliding hip screw. Because of the financial issues involved a cost~     benefit comparison for the two procedures is planned at the completion of the study.~      Primary outcome measures will be regain of walking ability. Secondary outcome measures~     recorded with include mortality, length of surgery, operative blood loss, blood transfusion,~     post-operative complications, hospital stay, need for subsequent revision surgery and degree~     of residual pain.~   "
30110|NCT03172910|"~     This study is a randomized, single-blind, placebo-controlled study to assess the efficacy and~     safety of ciraparantag administered to healthy volunteers anticoagulated with rivaroxaban~     measuring clotting times using Whole Blood Clotting Time (WBCT).~   "
30111|NCT03172897|"~     For patients undergoing mechanical ventilation, light sedation is better than deep sedation~     for the outcomes, which is manifested as shortened length of ICU stay, shortened duration of~     mechanical ventilation, and decreased mortality. In a recent study of the investigators,~     low-dose dexmedetomidine without sedative effects (0.1 ug/kg/h) improved sleep quality and~     reduced the incidence of delirium in elderly patients admitted to the ICU after surgery. The~     investigators hypothesize that, for ICU patients with prolonged mechanical ventilation,~     low-dose dexmedetomidine infusion (0.1 ug/kg/h) may also be effective in decreasing delirium.~     The purpose of this study is to investigate whether low-dose dexmedetomidine infusion can~     reduce the incidence of delirium in ICU patients with prolonged duration of mechanical~     ventilation (>= 24 hours).~   "
30112|NCT03172884|"~     To evaluate the pharmacokinetics and safety of copanlisib in subjects with impaired hepatic~     or renal function in comparison to healthy subjects~   "
30113|NCT03172871|"~     This is a phase 3, multicenter, randomized, active-controlled trial to assess the efficacy~     and safety of aripiprazole Intramuscular Depot in the acute treatment of adults with~     schizophrenia. The trial will include a 13-day screening phase and a 12-week acute treatment~     phase with a 14(±2)-day safety follow-up.~   "
30114|NCT03172858|"~     This study is designed to determine if an intracervical balloon catheter (IBC) is better than~     oxytocin for induction of labor in the setting of premature rupture of membranes (PROM) or~     breaking the bag of water prior to onset of labor. The investigators suspect that an~     intracervical balloon catheter will shorten the time interval from initiation of induction of~     labor to delivery.~   "
30115|NCT03172845|"~     To determine the clinical relevance of vulnerable plaque using OCT in patients with coronary~     bifurcation lesion.~   "
30116|NCT03172832|"~     The optimal approach to the drainage of malignant obstruction at the biliary hilum remains~     uncertain. This is a randomized comparative effectiveness study of percutaneous transhepatic~     biliary drainage (PTBD) vs. endoscopic retrograde cholangiography (ERC) as the first~     intervention in patients with cholestasis due to suspected malignant hilar obstruction.~   "
30117|NCT03172819|"~     This is multicenter, open-label Phase I study to exploratively evaluate the efficacy and~     safety of OBP-301 in combination with Pembrolizumab in patients with advanced solid tumors.~   "
30118|NCT03172806|"~     The aim of this study was to compare the ability of clinical scores (P-SAP, OSA50, DES-OSA,~     STOP-Bang with former algorithm, and STOP-Bang with new algorithm).~   "
30119|NCT03172793|"~     Due to emerging resistance, new antibiotic options are needed to treat CF acute pulmonary~     exacerbations caused by methicillin resistant Staphylococcus aureus (MRSA). There is~     established evidence that adult patients with cystic fibrosis (CF) may have altered~     antibiotic pharmacokinetics compared with non-CF patients. Telavancin is a lipoglycopeptide~     antibiotic that has activity against gram-positive bacteria including MRSA. This study will~     determine the pharmacokinetics and tolerability of telavancin in 18 adult CF patients~     admitted for a pulmonary exacerbation at 1 of 4 participating hospitals in the US.~   "
30233|NCT03171311|"~     The purpose is to compare median two-year clinical outcome after OCT guided vs. standard~     guided revascularization of patients requiring complex bifurcation stent implantation~   "
30120|NCT03172780|"~     This randomized, double-blind, three-arm, placebo controlled, bioequivalence study with~     clinical endpoint has been designed to establish clinical equivalence and safety of Mylan's~     diclofenac gel in the symptomatic treatment of steoarthritis of knee compared to Voltaren®~     gel and to establish superiority in efficacy of both compared to a placebo (vehicle) gel.~      Male or non-pregnant female aged ≥ 35 years with a clinical diagnosis of osteoarthritis of~     the knee according to the American College of Rheumatology (ACR) criteria~      Total study duration for the clinical part will be around 56 days that includes screening~     period of 28 days and treatment period of 4 weeks.~   "
30121|NCT03172767|"~     The study aims investigate sensory processing disorders and school readiness in pre-school~     preterm children and the relationship between sensory impairment and school readiness~   "
30122|NCT03172754|"~     This is a Phase I/II, open-label, multi-center study of axitinib in combination with~     nivolumab in patients with previously treated and untreated advanced RCC. This clinical study~     will be composed of a dose finding phase (Phase I) and two parallel dose expansion phases~     (Phase II). The dose finding phase will assess the safety of the combination and establish a~     recommended phase II dose (RP2D, the highest tested dose that is declared safe and tolerable~     by the Investigators and the Sponsor Investigator) in patients with advanced RCC who have~     received prior systemic therapy for metastatic disease. Phase II will evaluate the efficacy~     of the combination at the RP2D in two parallel expansion cohorts in both previously treated~     and treatment naïve patients.~   "
30123|NCT03172741|"~     Over the last two years, the United States has witnessed enormous change concerning the~     acceptance of marijuana. The number of persons with MS (PwMS) using cannabis to treat their~     symptoms is expected to rise, and it is important to provide clinicians and PwMS with~     evidence based information on the safety and effectiveness of marijuana. In addition,~     scientists need to identify the effects of medical marijuana as the compound action of~     different cannabinoids, specifically tetrahydrocannabinol (THC) and cannabidiol (CBD). The~     ratio of CBD to THC may have an important impact on the effects of the marijuana, which in~     turn may have important implications for the medical benefits. The overarching goal of this~     study is to advance a better understanding of the potential positive and negative effects~     associated with different strains of marijuana, using an interventional design. The~     investigators will examine three strains that differ markedly on THC potency (A. THC <1%, CBD~     > 10%; B. THC >10%, CBD < 1%; C. THC 510%, CBD 510%) to determine whether the level of THC is~     associated with differences in motor and cognitive functions in PwMS. One hundred PwMS will~     be recruited for this project and followed for 3 months following designation to one of three~     strains of marijuana with different ratios of CBD to THC or a placebo marijuana (THC 0%, CBD~     0%). It is hypothesized that the strains with a high CBD to THC ratios will demonstrate the~     most benefits on measures of motor and cognitive function.~   "
30124|NCT03172728|"~     The rationale for conducting the experiment including quantitative measures and a description~     of the method of recruitment:~      This study provides psycho-educational intervention aimed at raising awareness of post partum~     Obsessive-Compulsive disorder (OCD) , reducing the intensity of symptoms and increase of self~     referral to treatment. Various studies report that 1-11% of women after childbirth suffer~     from OCD. A part of this population suffered from the disorder prior to giving birth and for~     some this is a first outbreak. This is a psychological disorder characterized by obsessions~     and compulsions. The disorder can appear or worsen at any time , and is characterized by~     different content depending on the stage of life. Obsessional thoughts after birth often~     includes harming the baby which alarms the woman and the surrounding, and affects her ability~     to care for the baby and develop a beneficial relationship with him. Studies support a~     bio-psycho-social model of OCD .and that adjustment period and physical changes after~     childbirth can be create a psychological biological and environmental background, to the~     development or worsening of OCD in women who suffer from or are prone to the disorder.~      The present study deals with psycho-educational information which will be given to women~     after birth who were identified as susceptible to develop OCD. The information will be~     delivered in the maternity ward through written and recorded data , and sent through the~     system Qualtrics 4 weeks after birth. Psycho-education is an important first step in~     Cognitive Behavioral therapy for OCD and may lead to anxiety reduction and commitment to~     treatment. The information sent in the study is similar to the information provided at the~     beginning of standard Cognitive Behavioral Therapy.Women will be recruited from the maternity~     ward at Lis Maternity Hospital. In order to identify women at risk for OCD, All women in the~     maternity ward will be asked to fill a short questionnaire. Women found at risk or as~     suffering from OCD will be invited to participate in the study.~   "
30125|NCT03172715|"~     The aim of this study is to compare knee function and pain one year after treatment of~     intra-articular proximal tibia fracture using either osteosynthesis with a locking plate~     (ORIF) or primary total knee replacement (TKR) in patients over 65 years of age.~   "
30126|NCT03172702|"~     The Open-Label Maintenance Study contains an Correction Phase, in which subjects will be~     dosed with ZS 10 g three times daily (tid) for 24 to 72 hours, followed by a 12-month~     long-term Maintenance Phase.~   "
30127|NCT03172689|"~     To compare the less invasive Oesophageal Doppler cardiac output Monitor (ODM) to the invasive~     (standard of care) Transpulmonary Thermodilution cardiac output monitor (TPTD) in children.~   "
30128|NCT03172676|"~     Thrombocytopenia refers to a reduction in platelet count to (<150 × 109/L). Immune~     thrombocytopenic purpura is an acquired autoimmune disorder defined by isolated~     thrombocytopenia and the exclusion of other causes of thrombocytopenia~   "
30129|NCT03172663|"~     Obesity may directly or indirectly lead to hearing loss~   "
30130|NCT03172650|"~     Non-alcoholic fatty liver disease is the most common cause of chronic liver disease~     worldwide. It is defined as the accumulation of fat (>5%) in the liver cells in the absence~     of excessive alcohol intake or other causes of liver disease including viral, drug-induced,~     or autoimmune. Non-alcoholic fatty liver disease is a hepatic manifestation of metabolic~     syndrome.~   "
30131|NCT03172637|"~     A myriad of sexual problems affect men and women with chronic kidney disease (CKD), including~     decreased libido, erectile dysfunction, dysmenorrhea, and infertility. Menstrual~     abnormalities are common in CKD and many women are an-ovulatory .~      Causes of sexual dysfunction in CKD include hormonal alterations along with vascular,~     neurologic, psychogenic, and other factors, such as medications, contribute to the~     development of sexual dysfunction . Sexual dysfunction in females is mainly due to hormonal~     factors and manifests mainly as menstrual irregularities, amenorrhea, lack of vaginal~     lubrication, and failure to conceive.~   "
30132|NCT03172624|"~     The purpose of this study is to find out what effects, good and/or bad, treatment with two~     drugs called nivolumab and ipilimumab have on the participant and salivary cancer.~   "
30133|NCT03172611|"~     This study evaluates the effects of consuming a defined, plant-based diet on lipoprotein(a)~     and other atherogenic particles associated with cardiovascular disease risk.~   "
30136|NCT03172572|"~     RATIONALE: Minimally-invasive pancreatoduodenectomy (MIPD), either laparoscopic or~     robot-assisted, has been suggested as a valuable alternative to open pancreatoduodenectomy~     (OPD). The generalizability of the current literature is, however, unknown since randomized~     studies are lacking, and current data are published from few, very high volume centers and~     selection bias with a lack of case-matched series. International studies are lacking~     completely.~      OBJECTIVE: To compare outcomes of MIPD versus open pancreatoduodenectomy (OPD), in~     high-volume European pancreas centers (>10 MIPDs per year, total >20 PDs per year).~      METHODS: A retrospective multicenter propensity-score matched cohort study including all~     consecutive patients who underwent MIPD (or MI total pancreatectomy) between January 2012 and~     December 2016, for pancreatic head, bile duct, or duodenal cancer or cysts except chronic~     pancreatitis. Predefined electronic case report forms will be disseminated amongst~     participating centers. Participants are responsible for their own data collection. Matching~     of MIPD cases (collected from participating centers) to OPD controls (extracted from Dutch~     and German national registries) will be based on propensity scores determined by logistic~     regression including preoperative variables: year of surgery, demographics, BMI, ASA,~     comorbidities, tumor size, tumor etiology (diagnosis), and multivisceral resection. Primary~     outcome is 90-day major morbidity(Clavien-Dindo ≥ 3a). Secondary outcomes are 90-day~     postoperative events including: pancreatic fistula, length of hospital stay, R0~     (microscopically negative) resection margin, malignant lymph node ratio, days to adjuvant~     therapy and overall survival.~   "
30137|NCT03172559|"~     Liver transplantation (LT) represents the best treatment for patients with selected, early~     stage hepatocellular carcinoma (HCC). Due to the gap between the number of patients on the~     waiting list and the available donors, patients with HCC wait ~1 year to be transplanted.~     While waiting, 25-30% of patients need to come off the transplant list due to tumor~     progression beyond transplant criteria (extrahepatic disease, vascular invasion or increase~     in tumor burden beyond enlistment criteria). To try to avoid this progression, patients are~     treated while waiting with bridging therapies, mainly transarterial chemoembolization~     (TACE) and ablation. Around 30% of patients are not eligible for these treatments (.e.g. due~     to poor liver function). Stereotactic body radiotherapy (SBRT) has been shown to be an~     effective treatment for advanced HCC in primarily small, single institutional studies and its~     safety has been reported in cirrhotics. SBRT could be used in patients not eligible to TACE~     or ablation as a bridge to LT reducing the risk of progression in the waiting list. This~     study will evaluate if patients with liver cirrhosis and HCC benefit from receiving SBRT~     while awaiting LT. Patients will be randomized to a treatment arm where they will receive~     SBRT as a bridge therapy or to a no intervention arm. Outcomes prior and post to transplant~     will be performed to evaluate the differences between both arms: proportion of patients that~     do not drop-out of the list (are transplanted), liver decompensation while waiting,~     perioperative measures in those that are transplanted, time to transplant or drop-out,~     overall survival, disease-free survival in those that are transplanted in a population of~     about 330 patients across all sites.~   "
30138|NCT03172546|"~     The primary objective of the present study is to determine the clinical, biological and~     genetic determinants of the anticoagulant activity in patients treated with either anti-IIa~     or anti Xa oral anticoagulants.~      The secondary objective is to determine the clinical, biological or genetic determinants of~     hemorrhagic or thrombotic complications during a one year follow-up.~      Results will lead to a better prediction of both drug response and risk of complications.~   "
30139|NCT03172533|"~     The present study is a placebo-controlled randomised study on the effects of estrogen~     replacement upon AN-associated psychopathology, several neurocognitive domains and~     appetite-regulating circuits in female patients with AN.~      The investigators aim at assessing peripheral concentrations of neuroendocrinological~     components of the Hypothalamus-Pituitary-Gonadal (HPG) and Hypothalamus-Pituitary-Adrenal~     (HPA) axis, as well as appetite-regulating hormones in AN and to examine associations with~     AN-associated psychopathology and neurocognitive performances before (baseline), during and~     after inpatient psychotherapy of female patients receiving concomitant treatment with~     estrogens (vs. placebo).~   "
30140|NCT03172520|"~     The purpose of this study is to document the safety of the Medtronic automatic periodic~     stimulating (APS) Electrode Stimulator during a parotidectomy and potentially prevent~     post-operative facial nerve weakness, which is a relatively common outcome after parotid~     surgery.~   "
30141|NCT03172507|"~     An observational pilot proof-of-principle study. 15 patients with significant coronary artery~     disease and 15 matched controls. To investigate whether long-term activation of the innate~     immune system, named 'trained innate immunity', occurs at the level of the bone marrow~     progenitor cells in patients with significant coronary artery disease and whether this~     correlates with the proinflammatory phenotype of monocytes.~   "
30142|NCT03172494|"~     This trial is conducted in Asia. The aim of this trial is to confirm the efficacy of insulin~     degludec/liraglutide in controlling glycaemia in Chinese subjects with type 2 diabetes~     mellitus inadequately controlled on oral antidiabetic agents~   "
30143|NCT03172481|"~     This is a randomized, double-blind, parallel group, placebo-controlled, dose optimized, phase~     3 study to evaluate the safety and efficacy of PRC-063 in the treatment of ADHD in pediatric~     subjects between 6 to 12 years of age.~   "
30144|NCT03172468|"~     This study seeks to evaluate, whether patients suffering from cardiac arrest, that can be~     successfully resuscitated, can be differentiated from those, that cannot be resuscitated,~     using arterial blood pressure values.~   "
30145|NCT03172455|"~     An Early Access Program for patients with steroid refractory acute GvHD after hematopoietic~     stem cell transplantation.~      This Program is available for female and male who are recipients of allogenic HSCT and who~     have been newly diagnosed with acute GvHD.~      Alpha 1 antitrypsin is being tested in a Phase 2/3 Clinical Study to evaluate the safety and~     efficacy of Glassia (1-4) as an add-on bio pharmacotherapy to conventional steroid treatment~     in subjects with acute graft versus host disease with lower gastrointestinal involvement~     (NCT02956122).~   "
30147|NCT03172429|"~     The purpose of the current study is to evaluate the cerebral tissue oxygenation of Kyrgyz~     highlanders with high altitude pulmonary hypertension (HAPH) by performing a longitudinal~     cohort study. To this end, the investigators will invite the same highlanders who~     participated in the study in 2012 to undergo follow-up examinations in 2017, in order to~     allow comparisons of current results with baseline data from 2012.~   "
30148|NCT03172416|"~     PIPAC is a procedure that involves the administration of intraperitoneal chemotherapy using~     an innovative concept that enhances the efficacy by taking advantage of the physical~     properties of gas and pressure. The chemotherapy drugs will be delivered in aerosolised form.~     This results in a superior distribution and depth of penetration of the drug. This research~     study serves to determine the safety profile and tolerability of PIPAC with oxaliplatin. It~     may offer a novel and effective option of treatment for patients with peritoneal~     carcinomatosis, who, at present have limited options involving the use of systemic~     chemotherapy and who suffer from poor life expectancy and poor quality of life.~   "
30149|NCT03172403|"~     Cancer cachexia is responsible for the death of approximately 20% of patients. Myostatin is a~     master negative regulator of skeletal muscle mass. If the role of myostatin in cancer~     cachexia is now well established in murine models, no study has focused on muscle expression~     of Myostatin in relation to the degree of cachexia. the hypothesize is that muscle Myostatin~     a biological marker of cachexia in patients with colon cancer. The main objective is to~     compare skeletal muscle Myostatin messenger RiboNucleic Acid (mRNA) level as a function of~     cachexia in colon cancer patients. Myostatin messenger RiboNucleic Acid (mRNA) level will be~     determined in a muscle sample taken during the resection under general anaesthesia. Skeletal~     muscle index will be determined before surgery, 3 and 6 months after surgery. Muscle strength~     of the lower and upper limbs will be determined before resection, at 1 month, 3 months and 6~     months postoperatively. Blood sampling will also be performed on these 4 occasions.~   "
30150|NCT03172390|"~     Ascending aorta aneurysmal disease is common and can be complicated by dissection or rupture.~     There is substantial variation in individual aneurysm progression: established risk factors~     for an accelerated aneurysm growth rate include initial size or localization, the presence of~     aortic valve disease, congenital bicuspid aortic valve or connective tissue disorders.~   "
30151|NCT03172377|"~     Crohn's disease is a chronic inflammatory bowel disease. This disease can be treated with,~     among other things, biologicals such as adalimumab. Patients use adalimumab for a long time~     to maintain remission and to prevent relapse of the bowel inflammation. The disadvantages of~     this therapy are the high price and side effects (such as the higher risk of infection).~      Currently, adalimumab is given every 2 weeks, by injection under the skin. The optimal time~     between two injections has never been investigated before. Prior research in patients with~     rheumatoid arthritis shows that disease remission can be maintained with longer~     injection-intervals. Our hypothesis is that this is the same for Crohn's disease patients.~     Our aim is to show non-inferiority of extending the adalimumab dosing interval, under strict~     disease monitoring in Crohn's disease patients in sustained (>12 months) clinical remission,~     compared to standard care.~      During the trial,174 patients with stable Crohn's disease will be divided into 2 groups. One~     group continues adalimumab injections with the same 2-week interval. And the other group will~     incrementally extend the interval to 4 weeks, under strict disease monitoring. If a step-down~     leads to recurrence of disease activity patients will return to the preceding effective~     dosing interval. Thus, we will investigate whether, and for whom, it is safe to extend the~     adalimumab injection interval.~   "
30152|NCT03172364|"~     The objective of this clinical study is to assess the cutaneous and ocular local tolerance of~     two cosmetic facial cleansers in healthy female participants with sensitive skin under normal~     conditions of use.~   "
30153|NCT03172351|"~     prospective, comparative (3 arms), randomized, multicentric clinical trial~   "
30154|NCT03172338|"~     The onset and course of heart failure (HF) is triggered by a complex regulatory network that~     includes stressors (pressure overload by individual anatomic hemodynamic settings), intrinsic~     (genes), environmental (regulating epigenetics), and modifying factors (such as hor-mones and~     the immune system). SMART aims to establish individualized strategies for the prevention and~     management of HF by early detection of the physiological, genomic, proteo-mic and hemodynamic~     mechanisms that lead from onecommon cause of ventricular dysfunction (pressure overload) to~     maladaptive remodelling and irreversible HF. To cope with the complexity of HF, SMART will~     interrelate models describing the interplay between ge-nome, proteome and cell function,~     regulating hormones, tissue composition and hemody-namic whole organ function up to a whole~     body description of a patient and patient cohorts. The ultimate goal is to demonstrate~     proof-of-concept tools for predicting disease evolution and efficacy of treatment in a given~     patient. To achieve this task SMART will apply~        -  A modelling framework that couples multi-scale mechanistic models with in-depth~          genome/proteome, cell physiology and whole organ (biomechanical and fluid dynamic)~          models~        -  Subsequently, investigate methods validity and relevance for quantitative prediction~          of treatment outcome in a clinical proof-of-concept trial (demonstrator) of patients~          with aortic valve desieases.~   "
30155|NCT03172325|"~     The purpose of this study is to compare the efficacy and safety of adalimumab produced by~     CinnaGen company and AbbVie adalimumab in subjects with active Rheumatoid Arthritis. Patients~     with diagnosis of active Rheumatoid arthritis according to EULAR criteria (European League~     Against Rheumatism) aged between 18 to 75 years are included. This is a Phase III,~     randomized, two arms, double blind (patient and assessor blinded), parallel active non~     inferiority controlled clinical trial. The eligible patients are randomized in a 1:1 ratio to~     receive CinnoRA® or Humira®. Every 2 weeks, 40 mg of either of the drugs is administered to~     each patient subcutaneously along with methotrexate (15 mg/week), folic acid (1 mg/day), and~     prednisolone (7.5 mg/day) over a six-month period.~      The primary objective of this study is to assess equivalence of test- adalimumab (CinnoRA®)~     to the reference adalimumab (Humira®) in terms of efficacy in patients with moderate to~     severe active rheumatoid arthritis.~      The secondary objectives of this study are:~        -  To further compare efficacy of test- adalimumab to reference adalimumab~        -  To assess safety of test- adalimumab compared to reference adalimumab~   "
30156|NCT03172312|"~     Ready to establish the Intraoperative Parathyroid Scores System (IPSS) for thyroidectomy and~     study the clinical value of Intraoperative Parathyroid Scores System for thyroidectomy.~   "
30191|NCT03171857|"~     A wide variety of superficial soft tissue masses may be seen in clinical practice.~     Superficial soft tissue masses can generally be categorized as mesenchymal tumors, skin~     appendage lesions, metastatic tumors, other tumors and tumor-like lesions, or inflammatory~     lesions. The investigators will use doppler ultrasound in evaluation of superficial soft~     tissue masses characterization.~   "
30157|NCT03172299|"~     The reference treatment of ocular melanoma is a conservative treatment by proton therapy. Its~     goal is to treat the tumor while preserving the eyeball and visual acuity. However, ablation~     of the eyeball is sometimes necessary after proton therapy in the case of neovascular~     glaucoma. This complication occurs in 7 to 47% of cases (depending on the size of the tumor)~     and is associated with hypersecretion of Vascular Endothelial Growth Factor (VEGF) related to~     necrotic and inflammatory tumor tissue after proton therapy or ischemic retina. The~     intravitreal injections of anti-VEGF are used in the treatment of neovascular radicular~     glaucoma without avoiding enucleation in all cases. The investigators propose to study the~     prevention of neovascular glaucoma by intravitreal prophylactic administration of anti-VEGF.~   "
30158|NCT03172286|"~     A study in the postpartum period reveals that among women who delivered vaginally and having~     perineal lesions, between 95 and 100% of them suffer from perineal pain (episiotomy, tears~     from 1st to 4th degree) to 24 hours of vaginal delivery; and between 60 and 91% 7 days after~     delivery.~      Severe pain that is not taken into account can become chronic pain. It has physical and~     psychological consequences. It is therefore essential to prevent these risks in young~     mothers.~      The main objective of this study is to assess the efficacy of radiofrequency treatment on~     perineal pain postpartum, after a vaginal delivery, instrumented or not, in patients with~     perineal lesions.~      A double-blind randomized prospective single-center study will be conducted on patients~     delivering at Marseille's north hospital.~      Women who gave birth to the North hospital site, with perineal lesions (tears, episiotomy)~     will be invited to enroll in the study.~      Patients will be then randomized into two groups, one with radiofrequency treatment, the~     other without treatment with radiofrequency.~      The duration of inclusion is provided over 6 months. Each topic will be followed over a~     period of 1 month. The total study duration is 7 months.~      The expected results are a significant reduction in pain scores during the first days~     postpartum in women with perineal alteration caused by a vaginal delivery instrumented or~     not. Also an improvement in the quality of life of patients during the first days.~   "
30159|NCT03172273|"~     This multicenter RCT is designed to investigate if TIPS with covered stents improves~     transplant-free survival for cirrhotic patients with early stage of refractory ascites~     compared to LVP+albumin during 1 year follow-up period.~   "
30160|NCT03172260|"~     This is an observational study, to test the hypothesis that E Balance Pro Therapy~     micro-current treatments, delivered with precision in amplitude, waveform and pulsing~     pattern, adapted by other aspects of this device's technology could affect ion flow across~     cells and tissues in a fashion that modifies or transforms a crucial pathophysiologic deficit~     present in patients with diabetes. E Balance Pro Therapy can supplement standard treatment,~     as an adjunct, and help patients better manage their diabetes. HbA1C is the primary endpoint~     of this study. However, we expect to see changes in other symptoms (if present) associated~     with diabetes such as: blood pressure, insulin sensitivity, neuropathic pain retinopathy and~     wound healing.~   "
30161|NCT03172247|"~     Care of the diabetes is multidisciplinary with the involvment either private and hospital~     specialist~   "
30162|NCT03172234|"~     To evaluate the effect of oral amantadine versus gabapentin premedication on the hemodynamic~     response to laryngoscopy and tracheal intubation and their effect on β-endorphins.~   "
30163|NCT03172221|"~     This is a cross-sectional and multicentre clinical trial to study the performance of the~     Histidine Rich Protein 2 (HRP2) highly sensitive rapid diagnostic test (HS-RDT) for the~     detection of malaria during pregnancy in low transmission settings from Colombia and~     Indonesia. The new HS-RDT will be compared with conventional good quality RDTs, microscopy,~     and NAATs [loop-mediated isothermal amplification (LAMP), nested PCR (nPCR)], in peripheral~     blood samples with quantitative reverse transcription PCR (qRT-PCR) as reference standard.~   "
30164|NCT03172208|"~     Primary objective:~      To assess the safety and tolerability of single ascending intravenous (i.v.) doses, a single~     subcutaneous (s.c.) dose of caplacizumab (Part I), and multiple s.c. doses of caplacizumab~     (Part II) in Japanese subjects.~      Secondary objectives:~        -  To compare the pharmacokinetic (PK) and pharmacodynamic (PD) profiles (total vWF:Ag~          concentration levels [vWF:Ag], coagulation factor VIII [FVIII:C], and ristocetin~          cofactor activity [RICO]) after single i.v. or s.c. administration of caplacizumab in~          Japanese and White subjects.~        -  To evaluate the immunogenicity of caplacizumab (anti-drug antibodies [ADA]) in Japanese~          subjects.~   "
30165|NCT03172195|"~     Flare-up of ulcerative colitis (UC) is characterized by the inflammation of colon mucosa that~     requires the use of immunosuppressive therapies. In previous studies, the active role of~     cytomegalovirus (CMV) has been demonstrated, with a correlation between the cytomegalovirus~     DNA ((deoxyribonucleic acid) load in the inflamed tissue and the resistance to successive~     lines of immunosuppressive therapy (Roblin et al., Am J Gastroenterol 2011). The main aim of~     this monocentric prospective study is to evaluate the DNA viral load by qPCR (Polymerase~     Chain Reaction) of 3 herpesviruses (Epstein-Barr virus, herpes virus 6 and herpes simplex)~     together with that of CMV in colonic mucosa depending of the local inflammation~     (endoscopically normal region, inflamed mucosa or ulcer) in patients suffering of moderate to~     severe UC flare-up (Mayo score >6 with endoscopic score higher or equal than 2). The viral~     load will also be correlated to the Mayo endoscopic score and the response to~     immunosuppressive drugs (steroid and anti-TNF (Tumor Necrosis Factor) monoclonal antibodies).~   "
30166|NCT03172182|"~     Preoperative anxiety is associated with adverse consequences such as emergence delirium, and~     postoperative behavioral changes. According to previous studies, providing information of~     anesthetic procedures helps to lessen preoperative anxiety. However, verbal explanation alone~     provides the limited effect, and the tour program of the operating room prior to surgery may~     not be possible for a number of hospitals due to organizational and financial reasons.~     Therefore, the virtual reality (VR) tour of the operating room may be an innovative and novel~     method to give children information about the preoperative process and to alleviate the~     preoperative anxiety. In this study, we intend to evaluate the effects of the operating room~     virtual tour on preoperative anxiety as well as emergence delirium and postoperative~     behavioral changes, in pediatric patients.~   "
30203|NCT03171701|"~     The transplant is the definitive treatment of renal insufficiency, in our days. While waiting~     for it, the arteriovenous fistula surgery is standard procedure.~   "
30204|NCT03171688|"~     Investigators will observe the incidence of post-cesarean nausea or vomiting and try to~     associate it with some risk factors.~   "
30167|NCT03172169|"~     Through the literature screening of MyomiRX 7, the detection of mechanical ventilation group,~     difficult withdrawal unit and healthy adult plasma levels of MyomiRX in the evaluation of~     function and skeletal muscle thickness of the diaphragm, the correlation analysis of 7 kinds~     of MyomiRX and diaphragmatic dysfunction. The research value of this project is to explore~     the predictive value of plasma MyomiRX level on diaphragmatic dysfunction in patients with~     mechanical ventilation, and to lay the foundation for finding the target of VIDD diagnosis~     and treatment~   "
30168|NCT03172156|"~     CtDNA detection is a noninvasive detection method, and the second generation of~     high-throughput gene sequencing (NGS) is an important means of detecting ctDNA, which can~     detect trace ctDNA from smaller plasma samples. This project is to study the role of ctDNA~     dynamic monitoring of stage I NSCLC by NGS technique to verify the prognostic predictive~     effect of ctDNA .~   "
30169|NCT03172143|"~     The purpose of this study is to determine if taking an increased sampling of mesentery (fatty~     tissue next to the intestine) and lymph nodes at the time of the subject's ileocolic~     resection prevents a 4-6 month recurrence of Crohn's disease at the site of the new~     connection.~   "
30170|NCT03172130|"~     Chronic cough is an important clinical problem in primary care and sub-specialty practice.~     Besides the distress experienced by patients with chronic cough, significant healthcare~     resources are expended to understand the role of gastroesophageal reflux, asthma and~     post-nasal drip in understanding their contribution to cough.~      Obstructive sleep apnea (OSA) is common in patients with chronic cough. More importantly,~     treatment of OSA with continuous positive airway pressure (CPAP) has led to improvement in~     cough for chronic cough patients. Mechanisms by which OSA therapy with CPAP can improve cough~     includes beneficial effects on reflux and airway inflammation.~      The aim of this study is to definitively establish that CPAP therapy for treatment of OSA in~     chronic cough patients improves cough. While these patients with chronic cough are not~     routinely screened and treated for OSA, this study aims to evaluate these chronic cough~     patients with screening questionnaires for OSA and if necessary with polysomnography and~     randomize them to either CPAP or sham CPAP for 6 weeks.~   "
30171|NCT03172117|"~     A long-term follow-up study to obtain safety and efficacy data in subjects who completed~     phase 1/2a clinical trial of NEUROSTEM® (NCT02054208), comparing NEUROSTEM and placebo groups~     for up to 36 months after the initial administration in patients suffering from Alzheimer's~     disease~   "
30172|NCT03172104|"~     Research question: The primary aim of this study is to compare the prevalence of motor~     impairment from birth to five years of age between children born <30 weeks and term-born~     controls, and to determine whether persistent abnormal motor assessments in the newborn~     period in those born <30 weeks predict abnormal motor functioning at age five years.~     Secondary aims for both children born<30 weeks and term children are i) to determine whether~     novel early magnetic resonance imaging (MRI) - based structural or functional biomarkers are~     detectable in the neonatal period that can predict motor impairments at five years, ii) to~     investigate the association between motor impairments and concurrent deficits in body~     structure and function at five years of age, and iii) to explore how motor impairments at~     five years, including abnormalities of gait, postural control and strength, are associated~     with concurrent functional outcomes including physical activity, cognitive and learning~     ability, behavioural and emotional problems.~      Design: Prospective longitudinal cohort study. Participants and Setting: 150 preterm children~     (born <30 weeks) and 151 term-born children (born >36 completed weeks' gestation and~     weighing>2499 g) admitted to the Royal Women's Hospital, Melbourne, were recruited at birth~     and will be invited to participate in a five-year follow-up study.~      Procedure: This study will examine previously collected data (from birth to two years) that~     comprises the following: detailed motor assessments and structural and functional brain MRI~     images. At five years, preterm and term children will be examined using comprehensive motor~     assessments including the Movement Assessment Battery for Children - 2nd edition and measures~     of gait function through spatiotemporal (assessed with the GAITRite® Walkway), dynamic~     postural control (assessed with Microsoft Kinect) variables and hand grip strength (assessed~     with a dynamometer); and measures of physical activity (assessed using accelerometry),~     cognitive development (assessed with Wechsler Preschool and Primary Scale of Intelligence)~     and emotional and behavioural status (assessed with the Strengths and Difficulties~     Questionnaire and the Developmental and Wellbeing Assessment). Caregivers will be asked to~     complete questionnaires on demographics, physical activity, activities of daily living and~     motor function (assessed with Pediatric Evaluation of Disability Inventory, Pediatric Quality~     of Life Questionnaire, the Little Developmental Co-ordination Questionnaire and an activity~     diary) at the 5 year assessment.~      Analysis: For the primary aim the prevalence of motor impairment from birth to 5 years will~     be compared between children born <30 weeks and term-born peers using the proportion of~     children classified as abnormal at each of the time points (term age, one, two and five~     years). Persistent motor impairments during the neonatal period will be assessed as a~     predictor of severity of motor impairment at 5 years of age in children born <30 weeks using~     linear regression. Models will be fitted using generalised estimating equations with results~     reported using robust standard errors, to allow for the clustering of multiple births.~      Discussion/Significance: Understanding the developmental precursors of motor impairment in~     children born <30 weeks is essential to limit disruption to skill development, and potential~     secondary impacts on physical activity, participation, academic achievement, self-esteem and~     associated outcomes, such as obesity, poor physical fitness and social isolation. Better~     understanding of motor skill development will enable targeting of intervention and~     streamlining of services to the individuals who are at highest risk of motor impairments.~   "
30173|NCT03172091|"~     The aim of research is to identify markers of acute rejection by VOC analysis in exhaled~     breath of bilateral-lung transplanted patients. 120 bi-lung transplanted patients will be~     divided into two groups : patients with acute rejection diagnosed on transbronchial biopsies~     and patients with no acute rejection. Exhaled breath will be collected for VOC analysis woth~     electronic nose and mass spectrometry. VOC profiles will be compared between the two groups~     of patients.~   "
30174|NCT03172078|"~     To compare the total amount of propofol used by the manually-control infusion (MCI) and~     Target-control infusion (TCI) using standard monitoring without BIS or standard monitoring~     with BIS during advanced endoscopic procedure.~   "
30175|NCT03172065|"~     Conventionally General anaesthesia remains the choice for the majority of open abdominal~     surgical procedures, and regional anaesthesia is preferred only for patients who are at high~     risk under general anaesthesia . The main reason for selecting spinal anaesthesia as the~     first choice for laparoscopic cases was its advantages over general anaesthesia which include~     uniform total muscle relaxation, a conscious patient, economical, relatively uneventful~     recovery, pain free early postoperative period and the protection from potential~     complications of general anaesthesia. The main debatable point, however, seems to be the~     status of respiratory parameters among the two modes of anaesthesia during laparoscopic~     surgery. In this context it can be stated that spontaneous physiological respiration during~     spinal anaesthesia would always be better than an assisted respiration as in general~     anaesthesia.~      The pneumo-peritoneum induced rise in intra-abdominal pressure including pressure on the~     diaphragm and carbon dioxide induced peritoneal irritation are the factors to be considered~   "
30176|NCT03172052|"~     interventional randomized clinical trial will be done at Assuit University Hospital ( Chest~     Department and Caridothoracic surgery department ),and all patients presented with complex~     septate pleural effusion in whom the symptoms excepted to be relieved by pleural fluid~     drainage will be included in our study within the two next years.~   "
30177|NCT03172039|"~     This quality improvement study will assess the antimicrobial use and prescribing practices of~     hospital and community prescribers for the ambulatory hemodialysis (HD) population in an~     urban academic outpatient HD unit in Ontario. Currently, in the outpatient HD unit at Toronto~     General Hospital (TGH), it is the standard of care for the patients to be screened on a~     weekly basis by the nephrology care team for the use of any oral or intravenous~     antimicrobials. Patient charts, pharmacy patient profiles and electronic medical records for~     these patients from September 1 2016 - April 30 2017 will be retrospectively reviewed in~     order to characterize antimicrobial use and its concordance with available clinical~     guidelines and antimicrobial stewardship principles described by the Centers for Disease~     Control and Prevention (CDC). The primary objective of the study is to determine the~     prevalence of antimicrobial use in an ambulatory HD population. The secondary objective of~     the study is to determine the congruence of prescribed antimicrobial regimens with available~     clinical guidelines and antimicrobial stewardship principles described by the CDC. It is~     hypothesized that antimicrobial use among HD patients will be common and that antimicrobial~     prescribing practices are not congruent with recommendations from published clinical~     guidelines and antimicrobial stewardship principles for a significant proportion of patients~     included in the retrospective review. Descriptive analysis of the data will summarize the~     findings. Future research will build upon the results of this project, and may include the~     development of interventions that target gaps in knowledge and prescribing behaviours of~     prescribers who provide care to the ambulatory HD population.~   "
30205|NCT03171675|"~     This case control-study measures the levels of Interleukin-17 in gingival crevicular fluid~     and placental tissue samples of pregnant females as a possible marker in determining whether~     or not an association exists between chronic periodontitis and preterm labor. Interleukin-17~     is a pro-inflammatory cytokine whose levels have been proven to increase in periodontal~     disease.~   "
30178|NCT03172026|"~     After stroke, the combination of progressive skills practice in an adequate dose, exercise~     for fitness, and reduced sedentary time will augment motor and cognitive outcomes.~     Sensorimotor and cognitive improvements after stroke often reach a general plateau by~     approximately 12 weeks after onset, however. Drugs that might enhance learning or neural~     repair, as well as other molecular and synaptic adaptations that occur during skills training~     and fitness exercise, might extend that recovery curve, although to date only fluoxetine has~     given any hint of this. Most trials have tested agents that modulate neurotransmitters.~     Several very recent preclinical experiments and observational studies in patients after~     stroke suggest that the commercially available medication, Maraviroc, a CCR5 antagonist, may~     augment skills learning during rehabilitation training, especially during the first three~     months after onset, by affecting CREB and synaptic plasticity.~      The investigators will carry out a randomized controlled trial of Maraviroc in patients with~     disabilities severe enough to have required inpatient stroke rehabilitation and, based on our~     preclinical data, who can start the drug intervention within 6 weeks of stroke onset. The~     investigators will compare usual post-stroke care plus placebo versus Maraviroc given for 8~     weeks in 60 participants. However, to try to maximize the amount of practice that is most~     relevant to the primary outcome measurements and determine whether or not Maraviroc can~     enhance the effects of training, as hypothesized, all participants will be tele-monitored by~     mobile health devices and will receive weekly telephonic encouragement, based on device data,~     to walk, reduce sedentary time, and reach and grasp in the home in between usual care~     therapies. Compliance, serial motor changes over time, and self-management skills in making~     use of the telerehabilitation devices will be a nested substudy of feasibility of remote~     monitoring and feedback.~   "
30179|NCT03172013|"~     Spontaneous bacterial peritonitis (SBP) is an ascitic fluid infection in cirrhotic patients~   "
30180|NCT03172000|"~     Helicobacter pylori (H. pylori) infection is one of the most common infectious diseases in~     humans.~   "
30181|NCT03171987|"~     This is a prospective, randomized, single blinded, two-arm, head to head study.~      The purpose of this study is:~        -  To evaluate and compare the efficacy of 5% lidocaine patch and flurbiprofen patch for~          treatment of acute low back pain.~      Determining the effect of the 5% lidocaine patch and flurbiprofen patch for improving~     functional disabilities and in reducing pain resulting from acute low back pain. Efficacy~     will be determined by the level of pain relief (as measured by the Numerical Rating Scale,~     NRS), decrease in analgesics, improved quality of life (as measured by the Oswestry~     Disability Questionnaire, ODQ, and core outcome measures index questionnaire, COMI), pain~     interference with function (as measured by the Brief Pain Inventory-Interference scale,~     BPI-QoL), Short-Form McGill Pain Questionnaire-2(SF-MPQ-2), general health status (as~     measured by the EQ5D), Overall treatment effect (OTE), physical exam from baseline up to~     1-Months.~   "
30182|NCT03171974|"~     Ultrasound guided treatment of steroids for capsular contracture in patients with~     reconstructed/augmented breast~   "
30183|NCT03171961|"~     Online visit and online counseling via telemedicine technology is a new service for obese~     people who wish to lose weight but because of their active lifestyle and time limitation~     cannot come to clinic. The purpose of this study was to examine the efficacy this~     technology-based intervention on weight loss in obese and overweight female adults.~   "
30184|NCT03171948|"~     The purpose of this study is to assess the effects of limited portion of almond consumption~     after a successful weight loss by a comprehensive weight loss plan (NovinDiet Plan) on weight~     maintenance in obese female adults.~   "
30185|NCT03171935|"~     The main purpose of the present study is to verify whether, as compared with conventional~     weaning, early weaning with high-flow nasal cannula oxygenation or noninvasive positive~     pressure ventilation may more effective in shortening the duration of invasive ventilation,~     hence reducing the rates of complications and mortality in patients with acute hypoxemic~     respiratory failure.~   "
30186|NCT03171922|"~     The purpose of this study is to examine the efficacy of an internet based diet plus a regular~     dedicated dietary coach (ID group) versus clinic visit based weight loss program (CD group)~     on weight loss in obese and overweight female adults.~   "
30187|NCT03171909|"~     About one third of twin pregnancies are resulting from a single fertilized oocyte. Two third~     of these monozygotic twins share a common placenta and are therefore called monochorionic.~     Due to placental sharing and the ever-present inter-fetal vascular connections, specific~     complications may arise and lead to an increased risk of intrauterine death and long-term~     neurodevelopmental impairment. Specific complications include twin-to-twin transfusion~     syndrome (TTTS), twin-anemia-polycythemia sequence (TAPS), selective intrauterine growth~     restriction (sIUGR) and discordant major anomalies, occurring in about 10%, 5%, 20% and 6% of~     monochorionic diamniotic twins. Prenatal interventions may improve perinatal and long-term~     outcome of affected fetuses. However, general knowledge about early diagnosis of~     monochorionic twins and their specific complications is still limited in a significant number~     of practitioners in Austria and systematic analysis of pregnancy outcomes are not conducted.~      In this prospective multicenter registry study, the investigators aim to include all~     monochorionic pregnancies in Austria. Main outcome parameter is the occurrence of~     complications. Secondary outcomes are gestational age at occurrence of complications,~     gestational age delivery and neonatal outcome. The investigators also strive for long-term~     outcome, especially of infants following complicated pregnancies or preterm birth.~   "
30188|NCT03171896|"~     The experience of labor for a woman can be rewarding but can be traumatic. Medical clowning~     may alleviate the potential for trauma.~   "
30189|NCT03171883|"~     The supraspinatus is a relatively small muscle of the upper back that runs from the~     supraspinatus fossa superior portion of the scapula to the greater tubercle of the humerus.~     It is one of the four rotator cuff muscles and also abducts the arm at the shoulder. A~     supraspinatus tear is a tear or rupture of the tendon of the supraspinatus muscle.~   "
30190|NCT03171870|"~     Idiopathic pulmonary fibrosis is defined as a specific form of chronic, progressive fibrosing~     interstitial pneumonia of unknown cause, occurring primarily in older adults, limited to the~     lungs, and associated with the histopathologic and/or radiologic pattern of usual~     interstitial pneumonia.~      The definition of Idiopathic pulmonary fibrosis requires the exclusion of other forms of~     interstitial pneumonia including other idiopathic interstitial pneumonias and Interstitial~     lung disease associated with environmental exposure, medication, or systemic disease.~      Prevalence estimates for Idiopathic pulmonary fibrosis have varied from 2 to 29 cases per~     100,000 in the general population IPF should be considered in all adult patients with~     unexplained chronic exertional dyspnea, and commonly presents with cough, bibasilar~     inspiratory crackles, and finger clubbing.~   "
39869|NCT03044847|"~     The purpose of this study is to establish the large COPD cohort and biological database in~     China, aiming for precision medicine to optimize diagnosis and treatment choices and to~     monitor and improve clinical outcomes in this disease.~   "
30192|NCT03171844|"~     In the reanimation neonatal department of the Nice's hospital, 34% of newborns admitted have~     an umbilical vein catheter (KTVO). Their parents are admitted 24h/24h by their side, where~     everything is done to set up the Attachment (participation in care, skin to skin, support of~     breastfeeding, ...).~      The benefits of skin to skin described in developmental care of the newborn in the neonatal~     health services are well established. Nevertheless, for supposed risks (infectious and~     displacement of the catheter), registered in the memory of the teams, this care is not~     currently carried out when the newborns are carrying an umbilical venous catheter.~      Sometimes, because of the presence of an umbilical venous catheter, parents and their~     newborns could not enjoy this moment of well-being in the first days of life. We therefore~     propose a study evaluating the current risks of skin to skin with an umbilical venous~     catheter by reflecting on a new protocol for laying and fixing this medical device.~   "
30193|NCT03171831|"~     The purpose of the study is to assess the safety and efficacy of haploidentical hematopoietic~     stem cell transplantation for patients with thalassemia major.~   "
30194|NCT03171818|"~     The aim of the study is to perform a randomized double-blind placebo controlled prospective~     study in newborn infants with MRI confirmed Middle Cerebral Artery (MCA) Perinatal Arterial~     Ischemic Stroke (PAIS) with darbepoetin. It will be investigated whether intravenous~     administered darbepoetin can induce the formation of neuronal tissue and restore brain~     function in neonates who suffered from PAIS compared to placebo treated controls. The~     ultimate goal of this study is therefore to develop a therapy using~     erythropoiesis-stimulating agents (ESA) such as darbepoetin to reduce or even prevent~     lifelong consequences of PAIS-related brain injury in this group of term newborns.~   "
30195|NCT03171805|"~     Balloon-occluded retrograde transvenous obliteration (BRTO) has been effective method to~     manage gastric varices. However, more than one third of patients after BRTO treatment~     experienced worsening of esophageal varices. The present study was designed to evaluate the~     effect of post-BRTO propranolol adminstration on the change of esophageal varices.~   "
30196|NCT03171792|"~     The purpose of this study is to explore the perspectives of health professionals on chronic~     (non-malignant) musculoskeletal pain in adolescence and young adulthood. The prevalence of~     this pain symptom is rising for ten years, and most of the time the diagnosis is complex.~     Health professionals have to differentiate between the continuing activity of a somatic~     problem, some painful sequelae, a low threshold for the perception of pain, and psychological~     symptoms with somatic expression. Diagnosis in this case takes time, and is a matter of~     trained specialists. No protocol exists to assess the sub-clinical symptoms which will be~     used to help doing this complex task.~      This qualitative study will elicit the perspectives of trained specialists on this diagnosis:~     how do they deal with these patients? What signs and symptoms helps them? The results will~     present their clinical experiences. The overall goal is to construct the first chronic~     musculoskeletal pain multidimensional scale that will help the practitioners with this~     complex diagnosis.~   "
30197|NCT03171779|"~     More than 300,000 people die each year in France from a disease that may require palliative~     care. Nevertheless, only a small proportion of these patients are able to access this care,~     in particular because of a too late identification.~      While several factors may hinder access to specialized palliative care resources, one of the~     major barriers to the initiation of palliative care, and particularly to the implementation~     of quality end-of-life care, Remains the failure to recognize that patients with advanced~     chronic illness are actually approaching the end of their lives.~      However, it is now clearly established that early integration of palliative care in the care~     of people living with a serious, incurable and progressive disease:~        -  has an impact on the quality (and sometimes the expectation) of life of these people,~        -  avoids aggressive treatments and unplanned hospitalizations,~        -  is associated with lower health costs than other end-of-life patients. Primary health~          care providers have a major role to play in facilitating access to palliative care, but~          their practice has been hampered in our country by the fragmented and poorly coordinated~          nature of primary care and Negligible in terms of training. However, they remain the~          first contact of the patients with the system of care, and are also structuring for the~          continuation of the patient's journey within the health system.~      The first hypothesis is that the work of genuine interprofessional primary care teams in~     multi-professional health centers (MSPs), coupled with adequate training in the use of simple~     tools, can contribute to the early identification of patients approaching End of life, to~     meet their palliative care needs.~      However, various European programs (Gold Standards Framework in the UK, NECPAL in Catalonia,~     RADPAC in the Netherlands) have shown that identification alone is not enough to increase~     access to specialized palliative care. The second hypothesis is that it must be articulated~     for this with a training of the professionals to carry out conversations of anticipated~     planning of the care with their patients.~   "
30198|NCT03171766|"~     The main goal of the investigation is to identify the incidence of cognitive dysfunction and~     POD in patients older than 65 years of age undergoing neurosurgical elective surgery and~     determine if an association between cognitive dysfunction, basal NIRS and POD exists.~   "
30199|NCT03171753|"~     Music can reduce anxiety in adult patients awaiting surgical interventions. The study was~     designed to test the difference in cardiac parameters, anxiety questionnaire, laboratory~     enzymes, skin resitance between surgical patients listening music vs no sound.~   "
30200|NCT03171740|"~     Study where children will receive one premedication, either intranasal dexmedetomidine or~     oral midazolam, to reduce agitation on emergence of anesthesia. The hypothesis is that~     dexmedetomidine is superior but previous studies lack quality.~   "
30201|NCT03171727|"~     Transjugular intrahepatic portosystemic shunt (TIPS) dysfunction is defined as a loss of~     decompression of the portal venous system due to occlusion or stenosis of the TIPS. Occlusion~     of the TIPS can either be due to thrombosis or hyperplasia of the intima. Thrombosis of the~     TIPS usually occurs early and can happen within 24 hours of TIPS creation. The frequency of~     this complication is on the order of 10%-15% when bare stents are used. Post-TIPS short-term~     low molecular weight heparin (LMWH) was used to prevent the early thrombosis formation.~     Weather post-TIPS LMWH was necessary when polytetrafluoroethylene-covered stent was used~     during TIPS creation was not answered. The present study was designed to evaluate the effect~     of short-term use of LMWH on early TIPS dysfunction.~   "
30202|NCT03171714|"~     In this research study, a device called the Derma-Stent will be tested. The sponsor of the~     study, Mar-Med Company, will supply the device. This device is used to drain a cutaneous~     abscess, which is a skin infection that results in buildup of pus under the skin. Currently,~     the normal treatment for this abscess is to cut and drain and the wound, and later pack the~     wound with gauze. Packing is done to prevent the pus to accumulate again. But regular gauze~     is difficult for patient to remove themselves, so another visit to the doctor is usually~     necessary. The Derma-Stent device will be tested to see how easily patients can remove this~     by themselves and if it is less painful and more effective than normal gauze packing.~   "
30206|NCT03171662|"~     Appendicitis is the most common abdominal disease requiring surgery in children. The risk of~     developing appendicitis during a lifetime is reported to be 8.7% for boys and 6.7% for girls.~     Despite its high incidence, there are still diagnostic difficulties. The overall negative~     appendectomy rate among all children is suggested to be 8.4%, but in children under 6 years~     of age, the rate has been reported to be as high as 56.7% . The diagnosis of acute~     appendicitis is considered to be especially challenging in children due to difficulties in~     communication and examination.~   "
30207|NCT03171649|"~     Stroke is the third most common cause of death and the main cause of acquired adult~     disability in high-income countries. The most common deficit after stroke is motor impairment~     of the contralateral arm, with more than 80% of stroke survivors experiencing this condition~     in the acute phase, and only half regaining some useful upper limb function after six months.~      Within the European project RETRAINER (grant agreement No 644721), the consortium developed a~     platform for the rehabilitation of the upper limb after stroke, which combines a passive arm~     exoskeleton for weight relief supporting both shoulder and elbow movements, Functional~     Electrical Stimulation (FES) of the two-most impaired muscles of the affected side,~     interactive objects, and voluntary effort. The system also provides a graphical user~     interface which helps the therapist set the training session and save the training data and~     parameters, and provides the subject a visual feedback about his/her active involvement in~     the exercise. The training consists of the execution of a series of exercises involving the~     affected arm during daily life activities. Typical exercises are anterior reaching on a plane~     or in the space, moving an object on a plane or in the space, moving the hand to the mouth,~     with or without an object in the hand, and lateral elevation of the shoulder.~      The aim of this clinical study it to evaluate the efficacy of this novel training platform on~     patients between two weeks and nine months after their first stroke, who preserved at least a~     visible muscle contraction for the arm and shoulder muscles. Participants are randomized in~     an experimental and a control group. The control group is trained with an advanced~     rehabilitative program, including physical training, occupational therapy, FES, and virtual~     reality, while the experimental group is trained with the RETRAINER system for about 30~     minutes, in addition to the same program of the control group. The daily training time is the~     same for the two groups. The intervention consists of three sessions a week for nine weeks.~     Patients are assessed at baseline, soon after the end of the intervention, and in a 4-week~     follow-up visits. It is planned to recruit 68 subjects for this study.~      Since the RETRAINER platform was built on the up-to-date theory of motor re-learning, which~     supports task-oriented repetitive training, a close temporal association between motor~     intention and stimulated motor response, and an intensive and frequent training paradigm, the~     study's hypothesis is that the experimental group shows a greater treatment effect than the~     control group.~   "
30208|NCT03171636|"~     The assessment of the type and frequency of EGFR and KRAS mutations in lung cancer patients,~     as well as clinical-prognostic correlation, are crucial in the era of targeted therapies.~     EGFR-activating mutations predict responsiveness to EGFR tyrosine kinase inhibitors (TKIs) in~     non-small cell lung cancer (NSCLC) patients and KRAS analysis will be useful in a near future~     for newest target drugs. In Brazil, we have few data about the prevalence of EGFR and KRAS~     mutations and their knowledge would allow us to optimize personalized medicine.~   "
30209|NCT03171623|"~     This is a phase 1 randomized,double-blind,placebo-controlled study with single oral dose of~     globalagliatin hydrochloride (SY-004) administered to chinese healthy subjects to evaluated~     the safety, tolerability, pharmacokinetics and pharmacodynamics of globalagliatin~     hydrochloride (SY-004).~   "
30210|NCT03171610|"~     The purpose of this study is to compare the efficacy of iv PCA with fentanyl or sufentanil in~     patients undergoing laparoscopic nephrectomy~   "
30211|NCT03171597|"~     This study evaluates the clinical efficacy of the famous prescription in the treatment of~     unstable angina pectoris. All of the patients will be divided into 4 arms according to their~     syndrome type. One of the arms will be treated by conventional western medicine, the other~     three will be treated by different Chinese herbal medicine prescription at the base of~     conventional western medicine.~   "
30212|NCT03171584|"~     Onychomycosis refers to the fungal infection of the fingernails or toenails, caused by~     dermatophytes, yeast and non-dermatophyte molds that lead to distortion, discoloration,~     thickening and detachment from the nail bed~   "
30213|NCT03171571|"~     Unhealthy lifestyles are major factors contributing to chronic conditions that impose a huge~     financial burden in EU healthcare systems. Unfortunately, the communication of Public Health~     failed to influence consumer to change their habits. In this study, the aim is to evaluate~     the impact of a regular monitoring during 1 year on wellbeing and dietary habits in healthy~     volunteers.~   "
30214|NCT03171558|"~     This study will compare the gastric pull up (GPU) with the free flap [(specifically,~     anterolateral thigh (ALT) and radial forearm free flap (RFFF)] techniques used in the~     reconstruction of alimentary tracts in patients who require laryngectomy and circumferential~     pharyngectomy for carcinoma resection. These two interventions will be compared by block~     randomizing 20 patients based on history of failed chemoradiation to undergo either ALT or~     RFFF. The primary outcome will be the type and number of postoperative complications. The~     secondary outcomes will include swallowing function, speech, and quality of life measures~     along with cancer specific endpoints.~   "
30215|NCT03171545|"~     The purpose of this study is reduce episodes of intradialytic hypotension, low blood pressure~     during a hemodialysis session, in patients with End Stage Renal Disease (ESRD). Recruitment~     will take place on the clinic level rather than the patient level.~   "
30216|NCT03171532|"~     This study aims to study differences in clinical and functional outcomes at 2 years based on~     hamstring graft size after single bundle anatomic ACL reconstruction using either 4-strand or~     5-strand hamstring grafts. We also propose to study the characteristics of hamstring graft in~     our subset of patients in Asian population context.~   "
30217|NCT03171519|"~     Introduction: Chronic insomnia is a sleep disorder, characterized by difficulty in initiating~     and/or maintaining sleep, presence of non-restorative sleep, frequent awakenings or~     difficulty returning to sleep after each awakening, with a frequency of 3 nights/week, for at~     least 3 months. Pharmacologic therapy is the most commonly method used for its treatment,~     however, pharmacotherapy is associated with side effects. Thus, non-pharmacological therapies~     have been suggested as an alternative. Objective: To verify the effects of exercise~     associated with acupuncture on chronic insomnia. METHODS: 40 patients with chronic insomnia~     will be randomly assigned into two groups: CONTROL (n = 20) and ACUPUNCTURE (n = 20). The~     volunteers of the CONTROL group will be submitted to 12 weeks of aerobic exercise, performed~     on a treadmill, with frequency of 3 times / week and duration of 50 minutes / day.~     ACUPUNCTURE volunteers will perform aerobic exercise, following the protocol of the CONTROL~     group, plus acupuncture therapy once a week. The sleep evaluation will be evaluated by~     polysomnography and questionnaires. Expected Results: A 12-week combined therapy could~     potentiate the previously described positive effects of exercise in the treatment of chronic~     insomnia.~   "
39892|NCT03044548|"~     This is a cluster RCT in 6 health centres in Uganda, testing supportive supervision to~     improve health outcomes and quality of care of children with malnutrition~   "
30218|NCT03171506|"~     The objective of this investigation is to examine the effects of 12 weeks of usual care plus~     a ketogenic diet (KD) or usual care plus dietary recommendations endorsed by the Academy of~     Nutrition and Dietetics (AND) in women with ovarian and endometrial cancer. Participants~     undergo testing at baseline and at 12 weeks; the testing consists of blood draws,~     questionnaires, and measures of body composition. The baseline visit also includes a meeting~     with a registered dietitian to discuss the guidelines of the assigned diet.~      It is hypothesized that the KD group will have improved cancer outcome measures, beneficial~     body composition changes, reduced fasting concentrations of glucose and insulin, and higher~     ratings of patient satisfaction with the diet relative to the AND group.~   "
30219|NCT03171493|"~     This is a Phase 1 study designed to test the tolerability and feasibility of intravesical~     therapy with an attenuated Measles virus (MV-NIS) in patients with urothelial carcinoma who~     are undergoing radical cystectomy but are ineligible or do not desire neoadjuvant~     chemotherapy.~   "
30220|NCT03171480|"~     A randomized controlled trial (RCT) of nitric-oxide donor (NOD) isosorbide mononitrate (IMN)~     versus placebo as an adjuvant to misoprostol/ intra-cervical Foley bulb for induction of~     labor to decrease rate of cesarean deliveries in pregnancies complicated by preeclampsia~     (≥24/0 weeks' gestation)~   "
30221|NCT03171467|"~     Prophylactic salpingectomy (also called opportunistic, risk-reducing or incidental~     salpingectomy) has been advocated at the time of gynecologic surgery to reduce the risk of~     serous ovarian cancer. This study explores the acceptability and feasibility of opportunistic~     salpingectomy at the time of elective laparoscopic cholecystectomy (LCHE).~   "
30222|NCT03171454|"~     In this prospective, randomized, controlled study, the investigators wish to compare the~     efficacy of immediate and delayed intrauterine balloon (IUB) therapy in the prevention of~     adhesion reformation after hysteroscopic adhesiolysis.~   "
30223|NCT03171441|"~     This is a cross-sectional study aimed to investigate microvascular reactivity in prepubertal~     children according to adiposity status.~   "
30224|NCT03171428|"~     The performance of hepatectomy for liver tumors using the thoraco-abdominal approach (TAA)~     versus the abdominal approach (AA) is still debated.~      The aim of the study is the analysis of the perioperative outcome of patients operated with~     or without the TAA for liver tumors.~   "
30225|NCT03171415|"~     Obesity is a direct result of food-intake in excess of body energy expenditure. Thus,~     induction of increased energy expenditure via the activation of thermogenesis at targeted~     anatomical sites can counterbalance obesity. This trial aims to study RZL-012, a novel~     compound, in treating obesity by activating thermogenesis in subcutaneous fat.~   "
30226|NCT03171402|"~     The investigators are conducting a study to better understand how the average consumer~     differentiates between bitter and astringent sensations, both of which are typically~     unpleasant sensations characteristic of some healthy foods. Astringency is the dry/rough~     sensation elicited by foods such as green bananas and some wines. Although trained scientists~     can differentiate between these stimuli, untrained participants rate them similarly, despite~     their differences. This confusion has created additional barriers in understanding the~     mechanism of astringent perception, which is currently debated. Understanding how to design~     experiments where untrained participants can clearly evaluate both sensations will lay the~     foundation to better understand astringency.~      One mechanism that is believed to contribute to astringency is the interaction of astringent~     stimuli with salivary proteins. Interestingly, the salivary protein profile may be influenced~     by consumption of fruits and vegetables. Therefore, the investigators will evaluate how~     bitter and astringent perceptions differ among high and low consumers of fruits and~     vegetables by collecting saliva following exposure to the stimuli. This knowledge will inform~     approaches to increase the appeal of healthy food.~   "
30227|NCT03171389|"~     This is a non-randomized, open-label, multicenter phase 2 study to evaluate the efficacy and~     safety of ponatinib in patients with metastatic and/or unresectable GIST after prior failure~     or intolerability of imatinib. Patients will be enrolled into 1 of 2 cohorts based on absence~     (Cohort A) or presence (Cohort B) of KIT exon 13 resistance mutations as measured by liquid~     biopsy. A third cohort (Cohort C) will include patients who have received all approved lines~     of TKI treatments (imatinib, sunitinib and regorafenib).~   "
30228|NCT03171376|"~     Increased incidence of apical periodontitis was reported where root filling was found coronal~     to the marginal bone due to communication between pulp and periodontal space. It has been~     suggested to place intraorifice barrier in the canal to provide coronal seal. However there~     exists a void in literature regarding clinical validity of the termination of obturation~     apical to marginal bone and placement of intraorifice barrier in resolution of periapical~     pathology. Therefore this randomized controlled trial intends to investigate effect of~     coronal level of obturation on endodontic success and marginal breakdown.~   "
30229|NCT03171363|"~     The purpose of this study is to determine whether giving gaze-contingent feedback is an~     effective attention modification procedure, helping in the treatment of anxiety disorders in~     children.~   "
30230|NCT03171350|"~     Participants who meet the eligibility criteria and who consent to participation or whose~     parents/legal guardian consent to their participation, will be enrolled in the study for a~     period of up to 14 days. Enrolment visit (Day 1) assessments for all participants will~     include the collection of throat swabs, testing by staff at the site using the ellume·lab~     Group A Strep Test and testing for Group A Streptococcus by a central laboratory using~     bacterial culture and polymerase chain reaction (PCR). All participants will be followed up~     with a phone assessment of adverse events between Days 2-14.~   "
30231|NCT03171337|"~     Epidemiological studies show a one-year prevalence of 30%-60% for episodic tension-type~     headache (TTH) and 2%-3% for chronic TTH (CTTH). Many TTH patients seek acupuncture treatment~     worldwide, and CTTH is one of the most commonly treated. FSN has been used to treat CTTH~     recently; the curative effect of it was especially good for CTTH accompanying pericranial~     tenderness. Nonetheless, the effectiveness of acupuncture and FSN for CTTH remains~     controversial. Several research results showed that symptoms of TTH improve after acupuncture~     treatment, but these improvements were more subjective than objective measures. So, the aim~     of this study is to determine the cerebral function efficacy of acupuncture and FSN in the~     treatment of CTTH, using Headache impact test questionnaire (HIT-6), VAS to evaluate the~     subjective symptom and fMRI to detect the objective cerebral function changes.~      Intervention: device: acupuncture; Fu's subcutaneous; placebo sham acupuncture~   "
30234|NCT03171298|"~     Rectal cancer is one of the frequent malignant neoplasms ,Total mesorectal excision (TME) has~     become the gold standard treatment for middle and lower rectal cancers. Laparoscopic TME~     still be difficult in patients with low rectal tumors, narrow pelvic anatomy, male sex or~     high body mass index . Difficult visualization of the pelvic anatomy along with the~     limitation of rigid laparoscopic instruments may affect the quality of oncological outcomes~     and increase the risks of injuries during surgery. A down to up approach via transanal total~     mesorectal excision (TaTME) technique may overcome these problems~   "
30235|NCT03171285|"~     Although the mortality rate among soccer players is low, it causes much impact on the entire~     community and is a fascinating conundrum. The aim of this study was to evaluate the~     cardiovascular risk of soccer referees, to describe the frequency of cardiovascular risk~     considering age groups younger and older than 35 years old and to relate the Framingham and~     PROCAM indices for the comparison of cardiovascular risk in soccer referees. 50 referees of~     Paulista Soccer Federation were subjected to clinical and laboratory based evaluations at the~     Center for Sports Health at the Faculty of Medicine of ABC, and divided into two groups:~     lower and higher than 35 years of age.~   "
30236|NCT03171272|"~     The most commonly observed sequel after stroke is muscle weakness, which can also be~     identified in respiratory muscles, in the acute and chronic phases, and may compromise the~     lung function of these individuals. Studies have shown that lower Pimax values are found in~     non-community ambulators, and gait velocity has been reported as an important indicator of~     functionality after stroke, with higher gait velocity values associated with greater~     community participation and better quality of life.~      This study will test the hypothesis that training of the inspiratory muscles is effective in~     improving strength and endurance of the inspiratory muscles and functionality, including~     speed of gait, functional gait perfomarnce, activities of daily living and quality of life~     with stroke subjects.~      For this clinical trial, people after stroke will be randomly allocated into either~     experimental or control/sham groups. The experimental group will undertake training of the~     inspiratory muscles with the Power Breath Medical Classic device regulated at 50% of the~     subjects' maximal inspiratory pressure values, five times/week over six weeks, twice a day~     for 15 minutes, totaling 30 minutes/day. The control group will undertake the same protocol,~     but the participants will receive the devices with a minimal load, wich corresponds to~     1cmH2O. Both groups will participate in the rehabilitation program for 6 weeks. At baseline~     and post intervention, after the cessation of the interventions, researchers blinded to group~     allocations will collect the following outcome measures: maximal respiratory pressures,~     respiratory muscle endurance, functional gait performance, activities of daily living and~     quality of life. After 12 weeks will collect again maximal inspiratory pressures and~     functional gait performance.~   "
30237|NCT03171259|"~     Given the importance of understanding CLI patients' outcomes and existing gaps in knowledge,~     there is a pressing need to collect observational data on treatment patterns, adherence to~     performance measures, and outcomes that are relevant to patients and clinicians. To address~     this need, the current study will pilot test the research infrastructure and data elements~     needed to build a larger, national study collecting of the CLI population. It will also~     provide much-needed preliminary information to identify areas of action that can be targeted~     in quality improvement programs for this population. Most importantly, it will provide data~     on health status outcomes in patients with CLI, as a function of individual patient~     characteristics (demographics, socio-economic and clinical background) and the treatments~     that patients have undergone. The PORTRAIT-CLI study will also be well equipped to identify~     potential disparities in the provision of care and patients' outcomes as a function of~     patient's characteristics.~   "
30238|NCT03171246|"~     Crohn's disease (CD) is a chronic inflammatory condition of the gut with severe~     complications. There is strong evidence to suggest that diet and gut bacteria are key~     components in the onset, perpetuation and management of CD.~      An 8-week exclusive liquid diet (EEN) without any normal food is the best treatment for~     paediatric CD. The mode of action of EEN remains unknown, but according to recent~     publications, the modulation of the gut bacteria drives its therapeutic properties. While~     successful, EEN is a challenging therapy to follow. Half of the paediatric EEN patients will~     require a nasogastric tube to support treatment, its use in adults is limited, and the need~     for a more palatable diet is very well described. Based on these findings, a non-liquid and~     more acceptable dietary treatment was recently devised called CD-TREAT (Crohn's Disease~     TReatment-with-EATing) diet. CD-TREAT, which is a solid food-based diet designed to replicate~     the nutrients and food ingredients composition of EEN, was recently tested in healthy adults~     and a rat model of colitis. In order to pilot CD-TREAT diet as a CD induction treatment, 10~     children and 10 adults with active luminal CD will be recruited. Once consented, baseline~     blood, urine and faecal samples will be collected and the CD-TREAT prescribed for a maximum~     of 12 weeks. Another 3 blood, urine and faecal samples will be requested during the 12 weeks.~     All the foods/meals of the CD-TREAT diet will be purchased and delivered to the participants'~     house by the researcher and the meals which need cooking will be pre-prepared by a~     sub-contracted catering company. Blood and faecal inflammatory biomarkers will be measured,~     the disease activity assessed with routinely used clinical indices and the faecal bacteria~     and its metabolites characterised.~   "
30239|NCT03171233|"~     Dynamic knee valgus is an inadequate biomechanical movement of multifactorial cause that may~     expose the individual to various injuries. The range of motion of ankle dorsiflexion is one~     of the possible influencing factors. This study intends to compare the immediate effect of~     two techniques on ankle mobility and dynamic knee valgus.~   "
30240|NCT03171220|"~     The purpose of this study is to see the safety and efficient of neoantigen reactive T cells~     (NRTs) combined with programmed cell death-1(PD-1) inhibitor（SHR-1210）in the treatment of~     Chinese patients with advanced refractory solid tumors.~   "
30253|NCT03171051|"~     This study is being conducted to evaluate the ability of a light emitting diode (LED) study~     device's ability to raise the temperatures on flank tissue to a similar level compared to an~     approved laser device (SculpSure by Cynosure). Laser treatments have been shown to reduce fat~     in the flanks by heating the fat cells and causing them to burst. The contents of the cells~     are then cleared naturally by the body.~   "
30254|NCT03171038|"~     TEMA-HF 1 Long-Term Follow-up study is a follow-up study of TEMA-HF 1. It assessed the~     long-term impact of a 6-months telemonitoring program in chronic heart failure patients.~   "
30241|NCT03171207|"~     A novel body weight support device that uses pressurized pants may provide advantages in~     delivering gait therapy. The objectives of this study are to test the following hypotheses~     that 1) the novel device will allow for increased body weight support while improving or~     maintaining the same level of patient comfort; 2) the novel device will yield greater patient~     satisfaction with gait therapy relative to current harness systems; 3) therapists will be~     more satisfied with the use of the novel device relative to current harness systems; 4) the~     use of the novel device will require less total therapist time than a harness comparator; 5)~     the use of the novel device will increase therapeutic treatment time when compared with~     current harness systems.~   "
30242|NCT03171194|"~     The purpose of this study is to evaluate the safety of mesenchymal stromal cells (MSCs)~     obtained from umbilical cords for the treatment of adults with active systemic lupus~     erythematosus (SLE).~   "
30243|NCT03171181|"~     Motor control includes postural control and voluntary movement. For an optimal motor control~     it is necessary that brain integrates vestibular, visual and somatosensorial inputs properly,~     in a nonlinear way. Vestibular system, as an afferent organ, encodes head position in~     relation to gravity and changes in its linear and angular acceleration. As vestibular central~     system, it plays an essential role in motor control and in orientation and spatial memory as~     well.~      When a peripheral vestibular lesion occurs, elaboration, interpretation and processing of~     inputs are deficient and therefore motor control is altered to a greater or lesser degree. As~     process progress in time, there is a natural neuroplasticity that facilitates recovery or~     compensate vestibular function, although sometimes this process is incomplete and requires~     vestibular reeducation This study aims to assess changes in balance control, orientation and~     handicap perception in one case group with symptomatic unilateral peripheral vestibular~     dysfunction, before and after a rehabilitation programme (RV). To compare values obtained at~     the beginning and at the end of RV to those achieved by control group. Finally, this research~     aims to analyse evolution of spatial orientation quality in symptomatic and non symptomatic~     participants.~   "
30244|NCT03171168|"~     AposTherapy is a home based exercise program utilizing footwear that causes exercise with~     normal activity that may significantly improve function in patients with knee osteoarthritis~     since patients with knee osteoarthritis have altered mechanics of motion contributing or due~     to the presence of the conditions. Capitalizing on the reported excellent adherence and~     clinical benefit of ApostTherapy in patients with significant knee OA, the investigators~     propose to evaluate this as a conservative treatment that may supplant/supplement traditional~     pain medications and physical therapy in an at-risk urban inner city population.~   "
30245|NCT03171155|"~     To access the safety and performance of the XPro System to facilitate hemostasis in patients~     undergoing percutaneous endovascular procedures utilizing 8-18 Fr introducer sheath via the~     common femoral.~   "
30246|NCT03171142|"~     Helium is an inert gas with a density almost one-seventh of that of air. Based on its~     properties breathing a mixture of helium and oxygen (heliox) will lead to a reduction in~     resistance through narrowed airways and consequently decreases the work of breathing.~     Participating infants with RSV acute bronchiolitis will be supplied with heliox (ration of 21~     oxygen and 79 helium) delivered through a flow nasal cannula to evaluate heliox effect in~     improving their oxygenation. Heliox will act as an additive therapy to improve oxygenation in~     patients with lower respiratory tract infection caused by respiratory Syncytial Virus (RSV)~     and will decrease the need for more complicated therapies.~   "
30247|NCT03171129|"~     This study is to evaluate the feasibility of using a pressure limited nasal cannula system~     instead of a high flow nasal cannula system in the management of premature babies with~     respiratory distress.~   "
30248|NCT03171116|"~     Protein energy wasting (PEW) is a complex syndrome associated with different underlying~     illnesses and characterized by loss of muscle, with or without loss of fat. It is a highly~     prevalent condition among patients with chronic kidney disease (CKD), associated with~     increased morbidity and mortality.~      The pathophysiology of PEW in CKD is multifactorial and not yet completely understood. The~     potential role in uremic PEW of two of hormones involved in orexigenic/anorexigenic balance,~     ghrelin and obestatin, both derived from the ghrelin gene (GHRL), has been investigated in~     adults and, less extensively, in children. Aim of our study was to measure AG, UAG and~     obestatin concentrations in children with CKD and to assess their potential contribution to~     the development of pediatric uremic PEW.~   "
30249|NCT03171103|"~     prospective analytical study of all pregnant ladies with systemic lupus in Beni-suef~     localities~   "
30250|NCT03171090|"~     Patients will be randomly allocated according to computer - generated tables to one of two~     groups, group (A) ultrasonic guided sphenopalatine block using local anasthetic, group (B)~     ultrasonic guided sphenopalatine block using saline. Before induction anesthesia the~     following will be assessed, time needed to perform the technique, time till onset of the~     block, distribution of the block (Opthalmic, Maxillary, Mandibular) by needle brick.Intra and~     post- operatively the following will be assesse the quality of operative filed every 30 min~     intra-operatively using a pre- defined average category scale (ACS) (from 0 to 5), End tidal~     Sevo Flurane concentration will be recorded intra- operatively every 5 minutes, The total~     amount of Nitroglycerine used to achieve the target MAP and frequency of propranolol usage~     will be recorded,emergence time, postoperative VAS score and amount of meperdine used for~     rescue analgesia.~   "
30251|NCT03171077|"~     The purpose of this study is to determine the effects of use the Nintendo Wii® (NW) and~     therapeutic exercises by the method Proprioceptive Neuromuscular Facilitation (PNF) in the~     recovery of the motor function of poststroke hemiparesis patients.~   "
30252|NCT03171064|"~     Checkpoint inhibitors like the PD-1 antibodies Pembrolizumab and Nivolumab represent standard~     of care for patients with metastasized melanoma. Numerous high quality studies demonstrate~     that endurance and resistance training in cancer patients is safe and elicits beneficial~     effects. However, there is no systematic experience with regard to exercise interventions in~     patients undergoing checkpoint inhibitor treatment. Therefore, the Sportivumab Study aimed to~     investigate safety, feasibility and effectivity of a 12 week combined resistance and~     endurance exercise intervention program during checkpoint inhibitor treatment. It is planned~     to enroll 40 patients. Participants will be randomized into an experimental and a wait-list~     control group (20 per group). The wait-list control group will receive the exercise~     intervention program after week 13 of enrollment.~   "
30256|NCT03171012|"~     Post-stroke hemiparesis causes sequelae in the limbs and also in the trunk and abdomen~     structures. The level of physical activity decreases and cardiorespiratory training(CRT) is~     indicated to this population to improve the functions of several systems (respiratory,~     cardiovascular, muscular). The application of Proprioceptive Neuromuscular Facility(PNF)~     would imply in the awareness and greater harmony of the functions performed by the trunk of~     this individual. The objective of this study is to evaluate the effects of respiratory and~     trunk characteristics of the PNF associated with Cardiorespiratory training in quality of~     life, gait, distance traveled, peak oxygen consumption, respiratory muscle strength, thoracic~     cavity volumes, mobility and diaphragmatic thickness of individuals with post stroke.~   "
30257|NCT03170999|"~     It has been observed that COPD exacerbations are under-reported in China. One of the reasons~     for this is Chinese subjects with COPD cannot describe the symptoms of exacerbation mentioned~     in English. Hence this study aims to create a tool called CERT that will help Chinese~     physicians and subjects with COPD to recognize and report exacerbations. The study will be~     carried out in 4 stages: item identification, cognitive briefing, item reduction and creation~     of final CERTs. Two CERTs will be prepared, one for subjects with COPD and another for~     physicians. A total of approximately 200 subjects will be included in the study and each~     subject will contribute to only one step.~   "
30258|NCT03170986|"~     This study aims to test the hypothesis that a multi-sectoral agricultural and microfinance~     intervention designed to improve household food security, prevent antiretroviral treatment~     failure, and reduce co-morbidities among people living with HIV/AIDS will lead to~     improvements in the nutrition, health and development of children under 5 years old who~     reside in households of adults who participate in the Shamba Maisha intervention.~   "
30259|NCT03170973|"~     Introduction: The metabolism of fatty acids in plasma is modulated by their availability in~     plasma. Individuals with increased weight have increased plasma fatty acids and physical~     exercise seems to favor the metabolic responses of fatty acid mobilization. Objective: To~     test the hypothesis that the physical exercise of acute way changes the fatty acids of medium~     chain of the serum of individuals with increase of the corporal weight. Method: Including 66~     women, randomly divided into two groups, control and experiment, overweight, sedentary, and~     between 18 and 30 years of age. After a 12-hour fast, basal blood collection will be~     performed. The experiment group, 12 hours after the first collection, will be submitted to a~     physical exercise session with energy expenditure of 250Kcal. The volunteers in the control~     and experiment group will make a second blood collection 24 hours after the first one. The~     fatty acids will be dosed: pelargonic, azelaic, elaidic and oleic by gas chromatography.~     Intra and intergroup comparisons will be made using the t test for independent and dependent~     samples, p <0.05.~   "
30260|NCT03170960|"~     This is a multicenter Phase 1b, open-label study to assess safety, tolerability, preliminary~     efficacy, and pharmacokinetics (PK) of cabozantinib taken in combination with atezolizumab in~     subjects with advanced urothelial carcinoma (UC) (including bladder, renal pelvis, ureter,~     urethra), renal cell carcinoma (RCC), castration-resistant prostate cancer (CRPC), and~     non-small-cell lung cancer (NSCLC). The study consists of two stages: in the Dose Escalation~     Stage, an appropriate recommended cabozantinib dose for the combination with standard dosing~     regimen of atezolizumab will be established. In the Expansion Stage, tumor-specific cohorts~     will be enrolled in order to further evaluate the safety and efficacy of the combination~     treatment in these tumor indications.~   "
30261|NCT03170947|"~     Deformity and foot pain is nearly omnipresent (90%) in rheumatoid arthritis (RA), due to the~     interaction between inflammation and abnormal biomechanical. These cause instability in the~     hindfoot, which cause deformity of the forefoot, and they cause more pressure on the plantar~     forefoot and more pain during daily activities. Non-pharmacological interventions (insole,~     footwear) have an important role, reducing pain and disability, increasing the effectiveness~     and improving daily activities.~   "
30262|NCT03170934|"~     The proposed study will conduct a preliminary investigation of the effectiveness of two~     different psychotherapy classes at the Mental Health Crisis Response Centre (CRC) in reducing~     suicidal ideation. One class - Managing Difficult Emotions (MDE) - is an 8-session,~     Dialectical Behavioral Therapy-informed program that focuses on skills related to increasing~     tolerance for distress and emotion regulation such that harmful behaviors are reduced. The~     other class - Mindfulness-Based Cognitive Behavioral Therapy (CBTm) - is a 4-session program~     that focuses on challenging and changing maladaptive beliefs and behaviors in order to reduce~     distress. Both classes are delivered in lecture style, PowerPoint format. The investigators~     will also examine the effectiveness of participation in psychotherapy classes in reducing~     symptoms of general psychological distress, depression, anxiety, and emotion dysregulation.~   "
30263|NCT03170921|"~     The aim of this study was to characterize the psychophysiological demand in different~     Capoeira performances in male experienced individuals. Eleven men healthy and experienced in~     Capoeira. Participants were invited to five visits in different days: 1) anamnesis and~     anthropometric assessment; 2) aerobic performance assessment; 3 to 5) performance of 90s in~     three Capoeira styles (Angola, Benguela and São Bento). Main Outcome Measure(s): The~     physiological demand through the heart rate (HR), R-R interval (RRi), blood pressure (BP),~     blood lactate ([Lac]), and glucose ([Gluc]) and rating perceived effort (RPE), feeling scale~     (FS) and perceived activation (PA) were assessed after 10min of rest and during recovery (1,~     3, 5, 7 and 9min) of each performance. HR and RRi records also occurred during each~     performance.~   "
30264|NCT03170908|"~     The study is designed to observe the impact of improved measures of the fidelity on the~     community delivery of Interpersonal Psychotherapy. Pairs of therapist-patient dyads will be~     observed, first to develop and test brief measures of fidelity, and then to correlate those~     measures with symptomatic outcomes.~   "
30265|NCT03170895|"~     The study aims to test if combination of sorafenib and omacetaxine mepesuccinate (OM, also~     known as homoharringtonine) results in durable composite complete remission (CRc) in patients~     with newly diagnosed or relapsed/refractory (R/R) acute myeloid leukemia (AML) carrying~     FLT3-ITD (Fms-Like Tyrosine Kinase 3 - Internal Tandem Duplication).~   "
30502|NCT03167788|"~     The REDJUVENATE Trial proposes to test the hypothesis that postoperative organ injury and~     inflammation will be less if patients undergoing cardiac surgery who are at risk of large~     volume blood transfusion (defined as the administration of ≥4 units of red cells) receive~     rejuvenated washed cells compared to standard care (unwashed aged stored cells).~   "
30266|NCT03170882|"~     The purpose of this study is to compare the effect of ixazomib+dexamethasone (ixa+dex) versus~     pomalidomide+dexamethasone (pom+dex) on progression-free survival (PFS) in participants with~     relapsed and/or refractory multiple myeloma (RRMM) who have received at least 2 prior lines~     of therapy, including lenalidomide and a proteasome inhibitor, and are refractory to~     lenalidomide but not refractory to proteasome inhibitors.~   "
30267|NCT03170869|"~     The purpose of this study will be to prospectively evaluate the outcomes of patients with~     hepatocellular carcinoma (HCC) who undergo DEB-TACE (drug-eluting bead trans-arterial~     chemoembolization) with the Surefire Precision Infusion System for intentional effect of~     down-staging patients to OLT.~      Patients with HCC and who are considered candidates for liver transplantation but outside~     Milancriteria and meet the eligibility criteria will be enrolled in the prospective single~     arm study.~      Results of the prospective cohort will be compared to matched historical control patients who~     were previously treated with DEB-TACE, delivered with standard endhole catheters. This~     includes all patients treated at the University of Colorado since 2009 treated with 100-300~     micron beads for whom follow-up is available.~   "
30268|NCT03170856|"~     Patients who sustain a concussion will undergo a sub-maximal exercise protocol throughout~     their recovery. Cerebrovascular function, heart rate, and symptom duration will be monitored~     throughout.~   "
30269|NCT03170843|"~     This study is to evaluate the effectiveness of the plastic ring wound retractor to reduce the~     rate of surgical site infection in patients who undergo open abdomen surgery for~     gastrointestinal tract.~   "
30270|NCT03170830|"~     This is an observational diagnostic study that aims to evaluate the diagnostic value of~     circRNA-Uck2 in Acute Myocardial Infarction (AMI) in adults as compared to healthy and~     unstable angina controls. Rapid and adequate diagnosis of AMI is of great importance to~     enable a rapid start of treatment, save large tracts of dying myocardium, reduce the infarct~     size,and thereby decrease the risk of subsequent heart failure.~   "
30271|NCT03170817|"~     Accurate measurements from a non-invasive test like myocardial perfusion positron emission~     tomography/ computed tomography (PET/CT) may decrease the need for invasive procedures such~     as cardiac catheterization.The investigators wish to see if the measurements from cardiac~     catheterization can be predicted using a non-invasive 13N-NH3 digital PET/CT scan.~   "
30272|NCT03170804|"~     The purpose of this registry is to collect uniform genomics-centered data on patients with~     nodular thyroid disease and cancer in a prospective fashion. After initial clinical~     evaluation patients with thyroid nodules will undergo standard ultrasonographic evaluation~     and a needle biopsy of the thyroid (fine needle aspiration (FNA) or core biopsy) as~     clinically indicated. Biopsy samples will be evaluated cyto-pathologically. A~     molecular/genomic profiling will be obtained using Thyroseq v2 test. Surgical treatment will~     be performed as per clinically determined indications. Standard surgical pathology will be~     processed and reported per the institutional policy and procedures. A molecular/genomic~     profiling will be obtained using Thyroseq v2 on the surgical specimen. All patients~     undergoing thyroid nodule work-up may be enrolled. The registry will collect patient~     demographic and clinical data, cytopathology reports, and surgical pathology reports and~     slides (if/when a review is required).~   "
30273|NCT03170791|"~     This study will find out whether electrical stimulation of a nerve called the vagus nerve~     is acceptable for patients undergoing physiotherapy for arm weakness after a stroke. 20~     patients will be recruited if they had a stroke between 4 and 48 months previously and have~     been left with reduced function in the affected arm. Patients will receive 3 sessions of~     physiotherapy per week for 6 weeks. Each session will last 1 hour during which the patient~     will be asked to perform specific movements e.g. shuffling cards, reaching for a shelf. With~     each arm movement the therapist will turn on a stimulator which is worn clipped to the~     patients ear. This will deliver a short burst of electricity creating a mild tingling~     sensation.~      At the end of the session, the stimulator will be removed and the patient will be asked to~     rate the level of any discomfort or fatigue they experienced as well as any other side~     effects. The therapist will also record whether the stimulator device interfered with the~     therapy in any way. A heart tracing will be performed at each visit to check the heart~     rhythm. At the start and end of the 6 week course of physiotherapy, patients arm weakness and~     level of arm function will be assessed, as well as their general levels of fatigue, mood and~     quality of life. These will be reassessed at 1 month and 6 months after the course of~     physiotherapy has ended. The investigators will also interview patients to establish how they~     found the treatment itself. If the vagal nerve stimulation combined with physiotherapy is~     acceptable to patients and therapists and there are no safety concerns, the investigators~     will plan a larger trial of this treatment in stroke patients.~   "
30274|NCT03170778|"~     The purposes of this study are to identify indicators of vision problems and ocular~     abnormalities in patients with a Fontan circulation through a standardized questionnaire and~     to correlate the intraocular pressure measured with the Icare tonometer with central venous~     pressure measured with the VENUS 2000 CVP non-invasive system to determine whether~     intraocular pressure can be used as a surrogate measure of increased central venous pressure~     in patients with a Fontan circulation.~   "
30275|NCT03170765|"~     Measles is a preventable infectious viral disease. Since 1985, India has been administering a~     single dose of measles vaccine to all infants at 9 months of age. This age was chosen to~     balance the disappearance of maternal (transplacental) antibodies with the increasing risk of~     developing measles. Thus infants are expected to get protection against measles by acquired~     maternal measles antibodies derived trans-placentally from the mother for the first 9 months~     of life. Thereafter vaccine-induced antibodies are expected to protect infants.~     Seroconversion after measles vaccination does not take place as long as maternal measles~     antibodies persist in the infant. However, it is widely recognized that a substantial~     proportion of measles infection (10 to 15%) can occur among infants before the age of measles~     vaccination. Further, two small cohort studies done in our institution confirm that the~     majority of infants lose maternal antibodies by six months of age, making them susceptible to~     measles.This argues strongly for anticipating measles vaccination to an earlier age. However,~     such early vaccination has the risk that residual maternal antibodies (even if insufficient~     to protect infants) can neutralize the antigen in the vaccine, rendering vaccination~     ineffective. Therefore, a careful balance has to be chosen so that low levels of circulating~     maternal antibodies do not interfere with infants' response to vaccination. However, there is~     no prospective study in Indian infants to determine the seroconversion and sero-protection~     rate of earlier vaccination.~      This study has following aims and objectives:~        1. To study the level of measles specific immunoglobulin G (IgG) antibodies in a cohort of~          term infants followed from birth to 9 months of age; and the pattern of antibody decline~          in them.~        2. To compare the levels of antibodies in infants at these time points and correlate the~          levels with the antibody level in the respective mothers at the time of delivery.~        3. To compare the efficacy and safety of three different measles vaccination schedules in a~          cohort of term infants viz (i) vaccination at 9 months of age (current practice), (ii)~          vaccination at 7.5 months and 9 months of age, and (iii) vaccination at 6 months and 9~          months of age.~   "
30276|NCT03170752|"~     This study is a randomized controlled trial (RCT) and there will be two groups: an~     intervention group and a control group. Nurse practitioners (NPs) across Newfoundland and~     Labrador (NL) who agree to participate will be randomly assigned to one of the two groups.~     The NPs in the intervention group will be asked to screen about 30 individuals aged 40-74~     years without established cardiovascular disease (CVD) that currently come to their clinics.~     The NPs will be asked to screen these patients for CVD using a set of specific data~     collection tools that will be in electronic format. The control group will carry on with~     usual practice. Their charts will be reviewed by the researchers at a later date. At the end~     of the study, the screening program, with tools and strategies for CVD screening, will be~     given to NPs in the control group.~   "
30277|NCT03170739|"~     Acute kidney injury (AKI) is associated with complications that may lead to multiorgan~     dysfunction and potentially to multi-organ failure after major surgery. Dexmedetomidine is a~     highly selective alpha(2)-adreno receptor agonist widely used during anesthesia. In animals,~     dexmedetomidine has shown protective effects in AKI after surgery. Dopamine (DA) is an~     organic chemical of the catecholamine and phenethylamine families that has been widely used~     to increased renal blood flow and urine output during surgery. However, the clinical effects~     of dexmedetomidine and dopamine on renal function are still controversial. The aim of this~     study is to investigate whether dexmedetomidine and dopamine have positive effects on renal~     function after selective major surgery.~   "
30278|NCT03170726|"~     This study was planned to evaluate the analgesic efficacy of preemptive intravenous (iv)~     ibuprofen on pain occurring during and after the mandibular third molar surgeon~   "
30279|NCT03170713|"~     this study was planned to investigate the antiinflammatory activity of preemptive intravenous~     ibuprofen on inflammatory complications such as edema and trismus after third molar tooth~     surgery~   "
30280|NCT03170700|"~     The goal of this study is to further increase the impact of a validated and widely-used~     Eating Smart • Being Active EFNEP curriculum by teaching parents responsive feeding practices~     resulting in the development of healthier patterns of child eating behavior and food intake.~     Additionally, the effectiveness of two delivery strategies for adding feeding video-based~     content will be examined (in-person versus online lessons).~   "
30281|NCT03170687|"~     This study aims to compare outcomes of short leg cast and foot cast for treatment acute fifth~     metatarsal fracture (Zone II).~   "
30282|NCT03170674|"~     The purpose of this clinical study is to evaluate changes in biomarkers of exposure (BOE) to~     tobacco smoke constituents after smokers switch from combustible cigarettes to use of one of~     the three electronic cigarettes or abstinence.~   "
30283|NCT03170661|"~     A deep neuromuscular block (NMB) is often associated with improved surgical conditions~     especially in laparoscopic surgery. We previously showed that deep NMB is superior to a~     moderate NMB under propofol anesthesia. However, this may not apply to sevoflurane anesthesia~     and sevoflurane by itself produces some degree of muscle relaxation. We therefore plan to~     investigate the effect of deep NMB on surgical conditions under sevoflurane anesthesia~     maintenance.~   "
30284|NCT03170648|"~     This research study is evaluating ear acupuncture as a possible treatment to reduce symptoms~     related to receiving chemotherapy.~   "
30285|NCT03170635|"~     A mixed methods design was used to explore the outcomes of a 6-week, occupational therapy-led~     Refreshing Recess program designed to build capacity of recess supervisors to create a~     positive recess experience so that all students can successfully participate in and enjoy~     active play and socialization with peers.~   "
30286|NCT03170622|"~     Please see description below~   "
30287|NCT03170609|"~     This is the Phase 1/2 first-in-human, randomized, placebo-controlled, observer-blinded study~     evaluating the investigational multivalent group B streptococcus vaccine. Healthy adults aged~     18 to 49 years of age with no history of group B streptococcal vaccination will be randomized~     to receive either a single intramuscular dose of multivalent group B streptococcus vaccine~     (various formulations at 3 dose levels) or a placebo (saline control).~   "
30288|NCT03170596|"~     Post acne scarring is a common complication of acne. Cosmetic appearance of the post acne~     facial scarring can be improved by various methods. Among the procedural methods~     microneedling (1) is a novel and a promising option. It is a minimally invasive day care~     procedure for the management of atrophic acne scars. Topical tazarotene 0.1% gel is an~     effective medical method in the management of acne vulgaris and macular acne scars (2, 3).~     Based on its mechanism of action and role in collagen synthesis, topical tazarotene is a~     logical choice to investigate for the management of atrophic post acne scars. This is a pilot~     study comparing microneedling and topical tazarotene for the treatment of atrophic post acne~     scarring in regard to extent and rapidity of improvement, patient satisfaction and any~     adverse events if any.~      Thirty six subjects with grade 2 to grade 4 atrophic post acne scars, classified on the basis~     of Goodman's Qualitative classification (4) criteria will be recruited. Goodman's qualitative~     and quantitative acne scarring grading system scoring will be performed for the assessment of~     severity of acne scarring at baseline. The face of each patient will be randomized for~     monthly microneedling on one side and topical tazarotene 0.1 % gel once a day local~     application on opposite side, using computer generated random number table. Follow ups will~     be done at every month until treatment completion (3 months) and 3 months after the last~     treatment session. Goodman's qualitative and quantitative acne scarring grading system~     scoring will be performed at 3rd and 6th month follow up visits. An improvement by two grades~     will be considered as excellent, one grade will be rated as good and no up gradation will be~     labelled as poor response. Patients will be also assessed by a blinded observer for clinical~     improvement and scored on a scale of 0 (no improvement) to 10 (maximum) at 3rd and 6th month~     follow up visits with the help of serial photographs taken under consistent background,~     position and lighting. All patients will be instructed to assess themselves using Patients'~     Global Assessment Score 0 (no response) to 10 (maximum) at 3rd and 6th month follow up~     visits.~      The investigators hope the outcome of the present study may propose a newer medical modality~     for acne scarring, i.e topical tazarotene 0.1% gel, which can be used at home, obviating the~     need for physician dependant microneedling procedure.~   "
30289|NCT03170583|"~     The purpose of this post approval study is to evaluate the long-term safety of the FDA~     approved St. Jude Medical Tendril MRI™ lead implanted with a SJM Brady MRI implantable pulse~     generator (IPG) such as the Accent MRI™, Assurity MRI™, Endurity MRI™ pacemaker, or similar~     model (SJM Brady MRI System) in subjects with a standard bradycardia pacing indication.~   "
30290|NCT03170570|"~     this is a prospective clinical trial using intensity modulated radiotherapy（IMRT）for the~     treatment of cervical cancer patients with recurrent disease within the previously irradiated~     field. Sixty patients will be enrolled after careful selection to meet the inculding criteria~     and excluding criteria.A primary course of 36Gy will be prescribed to the recurrent site and~     a further 9-24Gy of dose escalation will be prescribed to the gross tumor volume in the~     second course according to the toxicities and the shrinkage of tumor. Weekly concurrent~     cisplatin of 30mg/m2 by five weeks will be administrated intravenously to the selected~     patients.Acute and late toxicities will be monitored and survival endpoints will be tracked~     with our follow-up protocol to evaluate the safety and effecacy of this approach.~   "
30291|NCT03170557|"~     Pain is one of the most common problems in patients with spinal cord injury (SCI) and~     persistent pain (that can be of different origin: nociceptive, neuropathic or mixed) is often~     poorly responsive to pharmacological therapy. Attention has been paid to the use of~     non-pharmacological therapies and interventional techniques in treating pain in other~     clinical conditions, and acupuncture has been the treatment most used and appreciated for its~     effectiveness. However, only few studies are available on the use of acupuncture in SCI~     patients. The present randomized, comparative trial aims to clarify the efficacy of~     traditional acupuncture vs. aspecific needle skin stimulation in treating persistent pain in~     subjects with spinal cord injury, by overcoming the biases reported in previous studies.~   "
30292|NCT03170544|"~     This is an active- and placebo-controlled, single-site, four-part trial of MK-1092 in healthy~     adult participants, in participants with type 1 diabetes mellitus (T1DM), and in participants~     with type 2 diabetes mellitus (T2DM). The primary hypothesis for this study is that at a dose~     with sufficient safety, the mean maximal glucose infusion rate (GIRmax) after single~     subcutaneous (SC) administration of MK-1092 in adult participants with T1DM is within an~     acceptable range. (Part 3)~   "
30293|NCT03170531|"~     The purpose of this study is to assess the image quality improvement provided by a custom MR~     spine coil in comparison with the FDA approved coil when used for radiotherapy treatment~     planning.~   "
30294|NCT03170518|"~     The purpose of this study is to assess the effect of canagliflozin relative to placebo on~     glycated hemoglobin (HbA1c) after 26 weeks of treatment, and to assess the overall safety and~     tolerability of canagliflozin after 52 weeks of treatment.~   "
30295|NCT03170505|"~     The fact that still exist is which method for repairing of secondary cleft palatal fistula is~     the best. This study will have shown whether using of Acellular dermal Matrix decreased the~     fistula formation versus using Conchal Cartilage during secondary fistula. Among studies that~     published, they have not consensus for using acellular dermal matrix. Most of the questions~     are about cost effectiveness, time that surgery and rehabilitation need and patient risk (~     risk of transmission disease from other human tissue )~   "
30296|NCT03170492|"~     Explanation of the study: As the older adult population continues to rise, so will normal~     cognitive aging. This increase raises concern for maintaining cognitive function and possibly~     delaying the onset of disorders such as dementia. Cognitive training (CT) is one potential~     solution which may be done using computer programs, pencil-and-paper problem solving~     activities, or everyday tasks. Traditional, skilled occupational therapy (OT) is not~     reimbursed for this type of preventative or maintenance services. CT may be a fundable answer~     for older adults to maintain or even improve cognitive function. The purpose is to determine~     if computerized CT, utilizing a specific program (RehaCom), improves executive functioning in~     the older adult with mild cognitive impairment, as compared to pencil-and-paper CT.~      How study is performed: Participants who meet the inclusion criteria will complete a~     9-question demographic survey and pre-test standardized cognitive tests. The experimental~     group will complete RehaCom computer training and the control group will complete~     paper-and-pencil based training. All trainings will take place at Mercy LIFE and will be~     conducted by trained OT students. Subjects will complete a total of 480 minutes of training~     over a 12-week period, within 30 to 60 minutes sessions. After the 480 minutes of training,~     subjects will complete the cognitive post-tests.~      How data is collected, de-identified and analyzed: Participants who enroll will be assigned a~     code number linked to their first and last name. This coding will de-identify participants~     before analyzing or reporting. All signed forms, data collected, and data identified will be~     kept in a locked cabinet in the researcher's office. All stored files will be shredded one~     year after the study.~      Interventions/tests/medications:~      Computerized CT: RehaCom is a computer program that was designed to assist cognitive~     rehabilitation. The program targets attention, concentration, memory, perception, and~     problem-solving, with trainings lasting for a total of 480 minutes over 12 weeks.~      Pencil-and-paper CT: Various pencil-and-paper exercises to improve attention, concentration,~     memory, language, and orientation will be used. Such exercises may include word puzzles,~     calculation or number puzzles, and map reading, for a total of 480 minutes of training over~     12 weeks.~      Potential risks: Risks of feeling segregated are minimal, as all members have been offered~     the opportunity to use the site's computer room. Risks may include cognitive fatigue (in both~     groups) or overstimulation during computer use. Breaks will be given at any sign of these~     symptoms. There is a small possibility that the participant may become too overwhelmed or~     stressed with the cognitive training. Upon notice of these symptoms, activities will cease~     immediately.~      Potential and expected benefits: Participants may gain a greater insight into cognitive~     abilities and improvement of executive functioning skills. Increased knowledge on effects of~     using cognitive software in a community-based setting may also occur. Mercy LIFE will receive~     the benefit of continued use of the RehaCom software and laptop as the equipment will be left~     at the site. Additionally, these findings may help other community-based sites incorporate~     specific cognitive training for other older adults.~   "
30297|NCT03170479|"~     i. To examine the impact of malnutrition on development quotient of children~      ii. To determine the effectiveness of Ready to Use Therapeutic Food (RUTF) in improving the~     development quotient of severe acute malnourished children under five year of age.~      iii. To investigate the outcome of Vitamin D therapeutic doses intervention with RUTF~     rehabilitation on growth and development of malnourished children.~   "
30298|NCT03170466|"~     Patients with advanced heart failure (HF) typically experience significant burdens that~     negatively impact their quality of life. Although palliative care has been shown to improve~     patient outcomes in other serious illnesses, insufficient data exist to support its use in~     HF. Furthermore, the demand for palliative care in serious illness outstrips the available~     supply of certified palliative care clinicians. This pilot trial will assess the feasibility~     and acceptability of training cardiology nurses in basic palliative care skills and their~     ability to deliver this care alongside usual HF management.~   "
30299|NCT03170453|"~     This study will investigate and confirm the efficacy of two psychological treatments for~     adults with autism spectrum disorder. Cognitive Enhancement Therapy (CET) is a cognitive~     remediation intervention that aims to help adults with problems in thinking, planning, and~     socialization. Enriched Supportive Therapy (EST) is an individual supportive therapy that~     aims to help adults learn about their condition, manage their emotions and stress, improve~     their social skills, and cope with everyday problems.~   "
30300|NCT03170440|"~     Post traumatic stress disorder (PTSD) and mild traumatic brain injury (mTBI) frequently~     co-occur, and these patients often have disrupted sleep. Poor sleep quality is associated~     with several poor heath outcomes that overlap with those that are experienced in PTSD. These~     can include poor cognitive performance and difficulty with emotional regulation. Effective~     treatment of sleep problems in these individuals could substantially improve these symptoms~     and quality of life. Transcutaneous vagal nerve stimulation (tVNS) is a non-invasive~     electrical stimulation technique that has been previously shown to moderate the response of~     the sympathetic nervous system and reduce hyperarousal in patients with mTBI and PTSD. In~     this study, our objective is to determine the effect of tVNS in changing sleep architecture~     and subjective sleep quality, as well as changing emotional and cognitive performance.~   "
30301|NCT03170427|"~     Impedance Cardiography (ICG) is a non-invasive tool for continuous hemodynamic monitoring.~     Aims of our study is to assess the utility of ICG to evaluate the hemodynamic impact of 6 mg~     (GL6) vs 8 mg (GL8) levobupivacaine combined with fentanyl in healthy patients undergoing~     elective cesarean section; secondary, to compare the duration and quality of analgesia and~     anesthesia~   "
30302|NCT03170414|"~     The primary objective of this study is to evaluate the safety of solid organ transplantation~     using HIV-positive deceased donors (liver, kidney) and HIV-positive living donors (liver) in~     HIV-positive recipients.~      HIV-positive individuals who agree to accept and receive a solid organ transplant from and~     HIV-positive donor will be followed to determine the safety and efficacy of this practice.~   "
30303|NCT03170401|"~     The aim of this study is too determine the effect of enteral protein supplementation on~     biochemical measures of inflammation and protein metabolism in critically ill surgical~     patients. The investigators will also collect data on important clinical outcomes, including~     infectious complications, duration of mechanical ventilation and other measures of recovery~     from critical illness.~      Hypothesis: That early supplemental protein will increase serum concentrations of~     transthyretin at three weeks after the onset of illness or injury. Secondarily, the~     investigators will test whether supplementation, reduces infectious complications and~     increases ventilator-free days.~   "
30304|NCT03170388|"~     A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group,~     Clinical Study in the Treatment of Acne Vulgaris~   "
30320|NCT03170180|"~     1. Metastatic gastric cancer patients who failed standard treatment will be enrolled in~          this study.~        2. After consent form, patient-derived cancer cell will be collected and tested with 3~          kinds of drugs (sunitinib, gefitinib, imatinib).~        3. Drug sensitivity prediction software (IRCR-DReSS) will present level of sensitivity and~          patients will be treated with sensitive drugs.~        4. Patients will be evaluated every 6 weeks.~   "
30305|NCT03170375|"~     Tens of thousands of Veterans have heart failure with preserved ejection fraction (HFpEF),~     and suffer poor quality of life, frequent hospitalizations, and high death rates. Older~     Veterans and those with high blood pressure, obesity, and the metabolic syndrome (abnormal~     cholesterol and resistance to insulin's effects) are particularly at risk for HFpEF. However,~     it is not clear why only some Veterans in this risk group eventually develop HFpEF. Extensive~     information from experimental animal models and some human studies suggests that dietary~     patterns in vulnerable 'salt-sensitive' people could contribute to the risk for HFpEF.~     Reducing salt intake and increasing overall dietary quality in at-risk Veterans could prevent~     heart and blood vessel damage that ultimately leads to HFpEF. Reducing the development of~     HFpEF, which currently has no definitive treatment, is highly relevant to the VA's mission to~     emphasize prevention of disease and population health.~   "
30306|NCT03170362|"~     The focus of this application is on the impact of providing depressed Veterans and their~     providers with the results of pharmacogenetic (PGx) testing for psychotropic medications. The~     project focuses on whether and how patients and providers use genetic test results given to~     them at the time an antidepressant is to be initiated to treat Major Depressive Disorder~     (MDD) and whether use of the test results improves patient outcomes. MDD is one of the most~     common conditions associated with military service and combat exposure, increases suicide~     risk, and worsens the course of common medical conditions, making it a leading cause of~     functional impairment and mortality. Validation of a PGx test to personalize the treatment of~     MDD represents an important opportunity to improve the healthcare of Veterans.~   "
30307|NCT03170349|"~     The purpose of this study is to assess the safety, performance and clinical outcomes of the~     Edwards PASCAL Transcatheter Mitral Valve Repair (TMVr) System.~   "
30308|NCT03170336|"~     Nowadays, the prevalence of chronic kidney disease (CKD) in China is about 10.8%,and nearly~     120 million people suffer from CKD, which has become a serious public health problem in~     China. Study confirmed that proteinuria is an independent risk factor for the continuous~     deterioration of glomerular filtration rate (GFR) in patients with CKD. So it is of great~     significance to explore the strategy of reducing proteinuria.~      According to our previous study, Amiloride can inhibit the expression of uPAR in podocytes~     and reduce proteinuria, This clinical trial aims to evaluate the effect and safety of~     Amiloride in decreasing proteinuria for patients with Chronic Kidney Disease.~   "
30309|NCT03170323|"~     Idiopathic membranous nephropathy (IMN) remains a common cause of the nephrotic syndrome in~     adults. There are few randomized clinical trials regarding the therapeutic effect of~     mycophenolate mofetil in patients with Idiopathic membranous nephropathy. This study aims to~     evaluate whether treatment with mycophenolate mofetil is non-inferior to cyclosporins in~     inducing long-term remission (complete or partial) of proteinuria in patients with idiopathic~     membranous nephropathy.~   "
30310|NCT03170310|"~     Subject ever received a standard chemotherapy solution progression or recurrence or can't~     tolerate chemotherapy with advanced esophageal squamous carcinoma.~   "
30311|NCT03170297|"~     The purpose of this study is to pilot data for a systematic molecular characterization of~     pathophysiologic perturbations incurred by snake envenomation and compare this to other~     inflammatory physiologic states such as trauma and sepsis. This sub-study will analyze~     samples of participants enrolled under the parent study Surgical Critical Care Initiative~     Tissue and Data Acquisition Protocol.~   "
30312|NCT03170284|"~     The purpose of this study is to examine the efficacy of Bevacizumab in addition to~     platinum-based chemotherapy for first-line treatment of participants with advanced stage~     (IIIB/IV) non-small cell lung cancer (NSCLC) other than predominantly squamous cell~     histology.~   "
30313|NCT03170271|"~     The purpose of this study is to investigate the effect of benralizumab on the rate of asthma~     exacerbations, patient reported quality of life and lung function during the 24-week~     treatment in patients with uncontrolled, severe asthma with an eosinophilic phenotype. A~     subset of patients will be assessed for their ongoing chronic rhinosinusitis with nasal~     polyps.~   "
30314|NCT03170258|"~     The purpose of this study is to see if a non-medication intervention can increase motivation~     and reward processing to non-drug reward cues (for example, a picture of one's favorite food)~     in individuals with and without nicotine dependence by observing brain activity using~     electroencephalography (EEG) and/or functional magnetic resonance imaging (fMRI). The~     investigators hypothesize that learning to increase brain activity to non-drug cues may~     improve reward responses and motivation to non-drug cues, and for individuals who smoke, may~     eventually result in improved smoking cessation outcomes.~   "
30315|NCT03170245|"~     Every year, 100,000 neonates are born with hemoglobinopathies around the world. Thalassemia~     is the most common heterogeneous disease of the human being . It is a disease of high~     prevalence in Mediterranean, Indian, North Chinese, and Pacific populations. Recently, the~     quantity and quality of the life of these patients have been significantly improved by~     regular transfusion and iron chelating therapy .~   "
30316|NCT03170232|"~     This is a pilot study to investigate the effect of danirixin hydrobromide 35 milligram (mg)~     tablets on lung function and health related quality of life (HRQoL) in subjects with mild to~     moderate airflow obstruction and a demonstrated history of decline in forced expiratory~     volume in one second (FEV1). Specifically, this study aims to assess whether or not danirixin~     has the potential to impact disease progression in subjects with a COPD progression score~     indicating they are likely to decline based on 5 year data from a COPDGene study and support~     the conduct of a larger Phase III study for disease progression. Subjects will receive either~     placebo or danirixin 35 mg tablets (as hydrobromide hemihydrate salt) twice daily for 52~     weeks (12months). Study subjects will continue with their standard of care inhaled~     medications (i.e. long acting bronchodilators with or without inhaled corticosteroids) while~     receiving study treatment. This study will be an ancillary study within the COPDGene study~     investigating the enrichment strategy for assessing disease progression. Potential subjects~     most likely to decline from the well established COPDGene cohort, will be based on data~     collected over the initial 5 year period. With the use of an enriched population, it is~     anticipated that one year of treatment will be sufficient to detect a trend in altering~     disease progression. Approximately 130 subjects will be screened to enroll 100 subjects in~     this study. The data from this study will provide useful information in determining whether~     to progress to a Phase III study to explore an indication for slowing disease progression.~   "
30321|NCT03170167|"~     The proposed pilot study is an evaluation of Communitas, a mind-body skills group visit and~     for 12-19 year-olds living with chronic physical illness. The goal of this study is to assess~     the efficacy and feasibility of these group visits. During 2017-2018, the investigators will~     recruit 50-100 patient and 50-100 parent enrollees of Communitas to participate in this~     study. The study will be a pre-post evaluation, without a control group, using validated~     patient-report assessments at baseline, after completion of the group visits, and 3 months~     later. The primary outcome variables will be physical and mental wellbeing, stress, mood,~     resilience, mindfulness, and social support. Paired t tests will be used to assess changes~     from baseline to immediately post-intervention & 3 months post-intervention. The~     investigators will also calculate Cohen's d effect sizes, to help them understand the degree~     to which an effect is present in the population.~   "
30322|NCT03170141|"~     This study is for patients that have a type of brain cancer called Glioblastoma multiforme~     (GBM). This study will combine two different ways to fight cancer: antibodies and CAR-T~     cells. Several immune checkpoint antibodies have been examined on various tumors with good~     outcomes. GBM is known to express increased levels of surface antigens that can be targeted~     by CAR-T cells. Thus, in this study, the 4SCAR-IgT cells targeting GBM surface antigens will~     be infused in dose escalation cohorts.~   "
30323|NCT03170128|"~     The purpose of this study is to investigate the effects of physical therapy as part of the~     non-operative treatment of radial head fractures.There is currently no data to support the~     use of physical therapy in the non-operative treatment of radial head fractures. Likewise,~     there is no data that shows that physical therapy is harmful to patients being treated~     non-operatively for radial head fractures. Investigators believe that prescribing physical~     therapy for patients with non-displaced radial head fractures treated non-operatively is~     unnecessary, and that that it would be equally efficacious to teach patients simple~     stretching exercises that they could perform by themselves. Subjects will be randomized into~     2 groups: Group 1 - Patients will be prescribed physical therapy within the first month~     following fracture; Group 2 - Patients will be given simple stretching exercises to perform~     at home and will not be given a prescription for physical therapy. Patients who agree to~     participate in this study and sign the informed consent will be randomly assigned to one of~     the two groups.~   "
30324|NCT03170115|"~     The benefit of aspirin in cancer of the colon and rectum is already known. Recently, it was~     described its potential activity during chemoradiotherapy, with higher rate of tumor~     downstaging. Furthermore, induction chemotherapy followed by chemoradiation represents an~     attractive approach, with more favorable compliance and toxicity profiles. The aim of this~     study was to evaluate the efficacy of total neoadjuvant treatment and assess the efficacy and~     feasibility of aspirin use during chemoradiotherapy for high-risk rectal cancer.~   "
30325|NCT03170102|"~     The study involved a one-group (n=19) mixed methods design using using pretest-posttest~     surveys and qualitative analysis of written reflections was used to explore the meaning and~     outcomes of participation in the building capacity process.~   "
30326|NCT03170089|"~     This study is designed to evaluate the effect of oral health educational program on the~     awareness and oral health status of children with Insulin Dependent Diabetes Mellitus.~   "
30327|NCT03170076|"~     -  Hepatitis C is an infectious disease caused by the hepatitis C virus (HCV) that~          primarily affects the liver. It is one of the main causes of chronic liver diseases~          worldwide .~        -  According to World Health Organization (WHO), 2011 , Egypt has particularly high rates~          of Hepatitis C (22%).~        -  Hepatitis C virus (HCV) is known to induce both hepatic and extra-hepatic~          manifestations. About 17% of HCV patients present with at least one skin manifestation,~          which can be directly or indirectly induced by chronic HCV infection .~   "
30328|NCT03170063|"~     The overall objective of this study is to compare the performance of available oligomeric and~     phosphorylated a-synuclein assay in cerebrospinal fluid and blood.~   "
30329|NCT03170050|"~     A multicenter, active-controlled, randomized, evaluator and subject blinded, split-face,~     comparative, non-inferiority, Medical device Clinical trial.~      This study is randomized, evaluator and subject blinded, split-face medical device Clinical~     trial. The Subjects are injected investigational device(YYD701-2 or Restylane Perlane~     Lidocaine) in right or left nasolabial folds.~   "
30330|NCT03170037|"~     This study hypothesizes that a novel reversal V-E ventilation technique will retain its high~     efficiency as that of standard V-E technique and will be easier to use.~   "
30331|NCT03170024|"~     Currently, both oral and written health education make certain assumptions about the health~     literacy of patients and their parents. The prevalence of health literacy issues is unknown~     in the adult congenital heart disease (CHD) population. Having a better understanding of a~     patient's and/or their parents' health literacy will help us develop appropriate education~     and teaching tools to meet the patient's and their parents' needs.~   "
30332|NCT03170011|"~     Patients with cardiac disease have been shown to have deficits in activities such as standing~     up from a chair. The Biodex Sit2Stand Trainer is a new device meant to improve sit to stand~     performance by providing a lifting force through the seat to help the individual stand. The~     amount of lift can be graded to help improve leg strength, endurance, and function over time.~     The device has the potential to be a form of training for those in cardiac rehabilitation who~     have limitations in standing from a chair.~   "
30333|NCT03169998|"~     -  It has been known that the recent application of a goal-directed fluid therapy (GDFT) to~          the intraoperative fluid infusion in patients contributes to decreasing the prevalence~          of postoperative complications and shortening the length of study in the intensive care~          unit as well as hospital stay compared with conventional methods.~        -  Laparoscopic surgery is in a trend that its application is being expanded recently, but~          there has been no report on the application of GDFT to laparoscopic surgery so far.~        -  To this end, this study aims to apply the intraoperative GDFT protocol in patients~          undergoing laparoscopic hepatobiliary or pancreatic surgery and to find out whether~          there is any difference in postoperative recovery and incidences of postoperative~          complications, by comparing with patients applied with the fluid therapy using existing~          conventional methods~   "
30334|NCT03169985|"~     The aim of this prospective, open-label, randomized, single center study is to compare the~     effect of usual dose rosuvastatin plus ezetimibe and high-dose rosuvastatin on modifying~     atherosclerotic plaque.~   "
30335|NCT03169972|"~     The purpose of this survey is to understand the following items in the actual clinical use of~     ADYNOVATE in patients:~        1. Unexpected adverse drug reactions~        2. Occurrence of adverse drug reactions in the actual clinical use~        3. Factors that may affect safety and efficacy~        4. Occurrence of Factor VIII inhibitor development in patients with coagulation factor VIII~          deficiency (hereinafter hemophilia A)~        5. Safety and efficacy for hemophilia A patients who received routine prophylactic therapy~          and on-demand therapy~   "
30336|NCT03169959|"~     A Study to Assess the Fed-state Bioequivalence of a Triple Fixed-Combination Drug Product~     (FCDP) of 2.5 mg Saxagliptin / 5 mg Dapagliflozin / 1000 mg Metformin XR and 5 mg Saxagliptin~     /10 mg Dapagliflozin /1000 mg Metformin XR Relative to Individual Components (Onglyza and~     XIGDUO XR) Co-administration. A randomized, open-label, cross over design has been chosen to~     minimize the effects of between-subject variability and any period effects on the overall~     results.~   "
30337|NCT03169946|"~     Considering the beneficiary properties of both Chlorhexidine (CHX) and Metronidazole (MTZ)~     such as property of substantivity and diffusion of these drugs on the external surfaces~     through the anatomical communication channels in between the root canals and periodontium,~     may be utilized as an alternative approach for the delivery of drug ( intracanal medicament)~     in the deep periodontal pockets in concurrent endodontic- periodontic lesion with~     communication lesions. Thus the aim of study is to conduct a prospective randomized~     controlled clinical trial to evaluate and compare the effects of CHX-MTZ combination with~     chlorhexidine alone as an intracanal medicament on periodontal healing in concurrent~     endodontic- periodontic lesion with communication.~   "
30338|NCT03169933|"~     Patients with high risk prostate cancer may benefit from radiotherapy after radical~     prostatectomy. The investigators postulated that adjuvant androgen deprivation therapy (ADT),~     radiation dose escalation, and selective pelvic irradiation may improve outcome. A phase II~     trial was designed to prove that combined-intensified-modulated-adjuvant (CIMA) treatment may~     improve 5-year biochemical relapse free survival (bRFS) from 75% to 90% in high risk~     patients. The delivered dose to tumor bed and pelvic nodes was 64.8-70.2 Gy and 45 Gy (57% of~     patients), respectively, and 69% received ADT.~   "
30339|NCT03169920|"~     This study evaluates the efficacy of M-MIST with or without PRF in the treatment of intrabony~     defects.Taking into consideration of advantages of PRF and M-MIST it was hypothesised that~     this combination (PRF+M-MIST) would be more beneficial in achieving healing of intrabony~     defects. Furthermore the concomitant use of Platelet Rich Fibrin with M-MIST has not been~     previously attempted in periodontal practice.~   "
30340|NCT03169907|"~     INTRODUCTION~      Circulatory changes associated with fetal anemia have an important role in maintaining~     sufficient tissue oxygenation. With fetal anemia, hyperdynamic circulation and increased~     cardiac output occurred. In current practice, using Doppler in assessment of the peak~     systolic velocity (PSV) of the middle cerebral artery (MCA) is the main parameter in~     screening of fetal anemia. Myocardial performance index (MPI) is a noninvasive technique that~     evaluates systolic and diastolic cardiac function by pulsed Doppler.~      Patients and Methods:~      This prospective study will be carried out on Women with singleton pregnancies with Rh~     isoimmunization who are scheduled to have intrauterine blood transfusion. Selected patients~     will be monitored weekly from 18 weeks gestational age till 28 weeks of gestational age.~      Venous and arterial Doppler indices:~        1. Middle cerebral artery (MCA) peak systolic velocity (PSV)~        2. Umbilical Artery Pulsitility Index (PI) and Resistant Index (RI)~        3. Ductus venosus (DV) Doppler~      Cardiac functions:~        1. Global cardiac function evaluated by Modified Myocardial Performance Index (Mod-MPI)~        2. Diastolic cardiac function evaluated by relationship between the maximal velocities of~          the E and A waveforms of ventricular filling (E/A ratio)~   "
30341|NCT03169894|"~     This is a Phase 1b, open-label, dose-escalation, signal-finding, single center study. The~     study will evaluate the safety, tolerability, pharmacokinetics and short-term efficacy of~     MDGN-002 in adults with moderate to severe, active Crohn's disease who have previously failed~     anti-tumor necrosis factor alpha (anti-TNFα) treatment.~   "
30342|NCT03169881|"~     Study Hypothesis: Preterm infants administered weekly Darbe during the neonatal period will~     have improved neurocognitive outcome at 22-26 months compared to placebo~   "
30343|NCT03169868|"~     The purpose of this study is to evaluate the clinical utility of a decision support tool, the~     Patient Medication Profile(TM), developed by Sano Informed Prescribing on medication~     reconciliation and identification of drug-related problems in patients with serious mental~     illness.~   "
30344|NCT03169855|"~     A) The main purposes of this study are (i) to develop a related virtual reality (VR)~     environment in order to judge the nighttime driving ability under mesopic and under glare~     conditions (ophthalmologically healthy subjects and patients with incipient to intermediate~     cataract, i.e. opacities of the human lens, will participate in this study), (ii) to validate~     the above-mentioned VR environment with respect to a related on-road driving scenario under~     mesopic and glare conditions, (iii) to validate clinical photopic and mesopic contrast vision~     tests and glare tests with respect to the prediction of nighttime driving ability, (iv) to~     assess the test retest reliability of clinical photopic and mesopic contrast vision tests~      B) Background:~      An intact mesopic vision and a glare sensitivity within a normal range are essential~     pre-requisites for safe driving at nighttime (DOG & BVA, 2011). Anderson & Holiday (1995)~     have shown that (simulated) opacities of the refractive media (with only minor effects on~     daytime visual acuity) induce a pronounced impairment of contrast sensitivity under nighttime~     conditions. Especially under glare conditions by the headlights of traffic on the opposite~     lane or by stationary street illumination, an impairment of the mesopic vision may cause~     traffic hazards. The prevalence of impairments of the central visual acuity, the mesopic~     vision and the glare sensitivity is significantly higher for subjects being involved in~     nighttime traffic accidents (Lachenmayr, 1998). Furthermore, these impairments occur more~     frequently in aged drivers and are, among others, related to an increase of age-related media~     opacities (Aulhorn & Harms, 1970, Babizhayev, 2003). Due to the demographic change, the~     relevance of nighttime driving ability is increasing in the next years since more and more~     aged employees will participate at the motorized traffic at night.~      The German Fahrerlaubnisverordnung (FEV i.e. driving license regulation) specifies pass/fail~     criteria with regard to mesopic vision and glare sensitivity. The luminance level during~     nighttime driving is usually between 0.01 and 1 cd/m^2, and therefore can be attributed to~     the level of mesopic vision. However, over the last years, the attempt was made to introduce~     photopic contrast sensitivity test to diagnose nighttime driving ability (i.e. testing of~     contrast vision under daytime conditions without time consuming adaptation procedures).~     Current research aims at investigating the relationship between contrast tests under various~     luminance conditions (Wilhelm et al, 2013). It is questionable, whether photopic tests are at~     all reliable predictors with regard to nighttime driving (Gramberg-Danielsen et al., 1984,~     Hertenstein et al., Graefe´s Archive of Ophthalmology, 2016).~   "
30345|NCT03169842|"~     This study evaluates the utility of using cyst fluid glucose levels to diagnose mucinous~     pancreatic cysts during endoscopic ultrasound-guided fine needle aspiration (EUS-FNA)~     procedures.~   "
30346|NCT03169829|"~     The purpose of this proof-of-concept controlled-feeding study is to evaluate the impact of~     plant-rich diets, with and without high-potassium fruits and vegetables, on phosphorus and~     potassium homeostasis in hemodialysis (HD) patients.~   "
30347|NCT03169816|"~     This study proposes to recruit patients with Opioid Use Disorder (OUD) seeking treatment into~     our program of outpatient detoxification and naltrexone induction followed by a~     relapse-prevention treatment with Extended release-naltrexone (XR-NTX) . Eligible~     participants will be randomly assigned to adjunctive treatment with lorcaserin (N = 40), or~     placebo (N = 20) with weekly therapy.~   "
30348|NCT03169803|"~     A feasibility study to investigate the safety and performance of the NeuroTronik Cardiac~     Autonomic Nerve Stimulation (CANS) Therapy System~   "
30349|NCT03169790|"~     This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination~     therapy in subjects with with CD20-positive NHL who have progressed on or after rituximab~     therapy.~   "
30350|NCT03169777|"~     This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination~     therapy in subjects with recurrent and metastatic CRC.~   "
30351|NCT03169764|"~     This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination~     therapy in subjects with HNSCC who have progressed on or after previous chemotherapy and~     anti-PD-1/PD-L1 therapy.~   "
30352|NCT03169751|"~     This is an observational study of subjects receiving standard of care therapy, while admitted~     to Epilepsy Monitoring Unit, Department of Neurology, General Hospital Hietzing with~     Neurological Center Rosenhügel. Additional monitoring provided by the SPEAC System will be~     compared to the gold standard, vEEG. The SPEAC System is being evaluated while being used in~     adjunct to standard of care.~   "
30353|NCT03169738|"~     This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination~     therapy in subjects with NSCLC who have progressed on or after treatment with PD-1/PD-L1~     inhibitors.~   "
30354|NCT03169725|"~     The purpose of the study is to evaluate safety and immunogenicity of inactivated~     poliomyelitis vaccine based on Sabin strain (LBVC) in healthy infants to select optimal dose~     of LBVC as well as to demonstrate the lot-to-lot consistency and non-inferiority of LBVC.~   "
30355|NCT03169712|"~     Sexual assault victims (SAV) have an elevated risk of developing posttraumatic stress~     disorder (PTSD). Trauma-focused cognitive-behavioural therapy (CBT) is an effective~     first-line treatment for this pathology. However, although sleep disturbances are a common~     complaint in SAV with PTSD, trauma-focused CBT does not directly address this symptom.~     Posttraumatic nightmares are widespread among SAV. Trauma-related sleep disturbances are~     associated with significant impairment in general functioning and quality of life (mental and~     physical health), and contribute to the maintenance of PTSD symptoms. This study evaluates~     the efficacy of sequential nightmare therapy (imagery rehearsal therapy; IRT) and~     trauma-focused CBT, in comparison to CBT alone. Forty-two SAV suffering from PTSD and sleep~     difficulties were recruited and randomly assigned to the experimental (IRT+CBT) or control~     condition (waiting period followed by CBT alone). Participants were administered a clinical~     interview and a series of questionnaires assessing PTSD symptoms, general functioning and~     quality of life.~   "
30356|NCT03169699|"~     To develop and validate a library of cough spectrum from a target of 1000 cough acoustics.~     Coughs arising from upper respiratory infection, lower chest infections, asthma, allergic~     conditions are included in the study. Cough acoustic in absence of respiratory disease is~     also included.~      This is a prospective observation cohort study recruiting children below the age of 16 years~     old in 2 arms : (1) Patients with respiratory conditions presenting with cough and (2) Well~     patients without active coughing.~   "
30357|NCT03169686|"~     This proposed (October 01, 2017 to December 31, 2018) project is to assess whether WeChat~     based, Interprofessional team support interventions ('WeChat WeQuit') will be effective at~     helping people in China who smoke, to quit.~   "
30358|NCT03169673|"~     Healthy volunteers aged 18-75 will undergo hyperpolarized 3-Helium MRI and pulmonary function~     testing for the development of tools to assess image signal to noise and reproducibility of~     spin-density and diffusion-weighted imaging.~   "
30359|NCT03169660|"~     The prognosis of exudative age-related macular degeneration (AMD) accompanied by submacular~     hemorrhage is generally poor. A recently developed anti-VEGF agent eyeliaTM is also a useful~     treatment option for exudative AMD. However, one major limitation of VIEW study was that lack~     of data regarding eyes with submacular hemorrhage. The purpose of the present study was to~     evaluate the efficacy of Eylea in submacular hemorrhage secondary to exudative AMD.~   "
30360|NCT03169647|"~     Metacognition, in-the-moment awareness of performance while engaging in cognitive tasks, is~     negatively affected by traumatic brain injury (TBI). Metacognitive deficits can greatly~     reduce quality of life for individuals with TBI as functioning in this domain has been~     closely linked with successful independent living and community re-integration.~     Problematically, there are currently no empirically validated treatment options that address~     metacognitive deficits after TBI. Recent research in healthy samples demonstrates that~     specific listening interventions may alter neural activation in brain works associated with~     metacognition and can improve metacognitive functioning; however, it remains unknown if these~     effects generalize to individuals with TBI. Thus, the objective of the proposed study is to~     use a double-blind, placebo controlled randomized clinical trial to determine the efficacy of~     applying a specific listening intervention to improve metacognition after TBI and to employ~     functional magnetic resonance imaging (fMRI) to document the neural mechanisms by which the~     intervention operates.~   "
30377|NCT03169426|"~     Remote ischemic conditioning has been shown to protect myocardium from ischemia-reperfusion~     injury during cardiac intervention or cardiac surgery. However, effect of beta-blocker,~     commonly used cardiovascular medication in patients with cardiac diseases such as~     hypertension or angina pectoris, on cardioprotective role of remote ischemic conditioning has~     not been well documented. The purpose of the study is to investigate the effect of~     beta-blocker on remote ischemic conditioning in healthy volunteers.~   "
30378|NCT03169413|"~     Diabetes mellitus is a group of metabolic diseases characterized by chronic hyperglycemia~     resulting from defects in insulin secretion, insulin action, or both.~      According to American Diabetes Association diabetes can be classified into the following~     general categories: Type one diabetes (due to beta cell destruction, usually leading to~     absolute insulin deficiency), Type two diabetes (due to a progressive insulin secretory~     defect on the background of insulin resistance), Gestational diabetes mellitus and specific~     types of diabetes due to other causes, example monogenic diabetes syndromes (such as neonatal~     diabetes and maturity-onset diabetes of the young, diseases of the exocrine pancreas, and~     drug induced diabetes.~   "
30361|NCT03169634|"~     Lay Person's Summary:~      Knee replacement surgery has been successfully carried out for many years. However, in time,~     some knee replacements will fail-usually either because of wear or loosening of the~     replacement parts. This may mean the patient has to undergo further surgery-this is known as~     revision total knee replacement (rTKR). This revision surgery is often more complex than the~     original operation and presents the operating surgeon with several technical challenges. Of~     particular concern, is that when the old knee replacement is removed, a large cavity can be~     left in the bone. The new knee replacement has to be placed into this, but it is essential~     that it is immediately stable and secure. The large cavity has to be somehow either filled in~     or bypassed to ensure the new knee replacement is secure enough for early weight-bearing and~     long term survival.~      Different techniques have been used for many years to overcome this problem. Firstly, it may~     be possible to simply cement another knee replacement into the cavity- probably needing more~     cement than was previously used.~      An alternative option to this is use a device called a cone which sits into the bony cavity~     created by removing the original knee replacement, and a new knee replacement can be cemented~     into this.~      Bone grows onto the cone to ensure its stability. The new knee replacement can have either~     short stemmed components like the original Total Knee Replacement (TKR), or long stemmed~     components.~      All of these types of rTKR are presently in use throughout the United Kingdom (UK). At this~     point in time, no-one knows which type is best. The research team are planning to run this~     study to see if it is possible to identify which type of rTKR gives the best outcome for~     patients. The research team will examine the results in different ways including~     questionnaires to measure how well the patients feel their knee is performing, specific tests~     to measure knee function, and by using x-rays and scans.~      The investigators will identify patients suitable for inclusion in the study from their~     medical notes, x-rays and scans. If patients consent to be in the study, the research team~     will randomly allocate them to receive one of the 3 rTKR options (no cone and new knee~     replacement only, cone with short stemmed components or cone with long stemmed components)~     and monitor their progress for 5 years after the operation.~      The investigators will identify patients suitable for inclusion in the study from their~     medical notes, x-rays and scans. If patients consent to be in the study, the investigators~     will randomly allocate them to receive one of the 3 rTKR options (no cone and new knee~     replacement only, cone with short stemmed components or cone with long stemmed components)~     and monitor their progress for 5 years after the operation.~      A preliminary analysis of the data generated by the study will be carried out 2.5 years after~     recruitment of the 1st participant to assess compliance with the study protocol.~   "
30362|NCT03169621|"~     Chronic endometritis (CE) is a persistent inflammation of the endometrial lining caused by~     the infection of the uterine cavity mainly by bacterial pathogens. It is known that CE can~     produce implantation failure, recurrent abortion and preterm labor. The study hypothesis is~     that patients who have repeated implantation failures (RIF) despite transferring good quality~     and normal embryos, diagnosed by preimplantation Genetic Diagnosis (PGD), into a receptive~     endometrium, diagnosed by Endometrial Receptivity Analysis (ERA), may present asymptomatic~     CE, being the altered endometrium the main cause of these implantation failures.~      The current diagnosis of CE is the microbiological culture of endometrial biopsy samples.~     Alternatively, examination of the uterine cavity by hysteroscopy is effective at 93.4%.~     However, both methods have limitations, such as the time needed to obtain the diagnosis, the~     economic cost of the tests, the possibility of detecting microorganisms in culture etc. For~     these reasons, the developing of a simple, fast, cheap and minimally invasive diagnostic tool~     for CE patients subjected to IVF treatments is expected. It would be very useful in order to~     establish a specific treatment and improve pregnancy rates in infertile patients. For this~     reason, the bacterial DNA present in the endometrial fluid samples will be obtained and the~     identification of the causative pathogens of CE will be done by sequencing (NGS) and/or~     quantitative PCR with specific oligonucleotides for the most common bacteria causing CE. The~     validation of this new method will be performed by comparison with the microbiological~     diagnosis of those same patients.~   "
30363|NCT03169608|"~     Characterization of the perioperative autonomic nervous system state, cardiovascular and~     cerebrovascular control and microcirculation in order to predict postoperative atrial~     fibrillation and acute kidney injury in patients undergoing coronary artery bypass graft~     surgery~   "
30364|NCT03169595|"~     The controversy surrounding epithelioid hemangioma diagnosis stems from its somewhat~     aggressive clinical characteristics, including multifocal presentation and occasional lymph~     node involvement.~      The investigators reviewed the clinicopathologic and radiologic characteristics of bone and~     soft tissue epithelioid hemangioma in patients treated at our institution with available~     tissue for molecular testing.~      The hypothesis is that epithelioid hemangioma may present with multifocal involvement and~     rare loco-regional lymph node metastasis, but it remains a benign tumor with excellent~     prognosis.~   "
30365|NCT03169582|"~     The main goal of this study is to compare the use of Avanafil versus Sildenafil in spinal~     cord injury erectile dysfunction. The study has the characteristics of a non- inferiority,~     randomized, crossover, open clinical trial. The principal variable is the IIEF-EF (Erectile~     Function Domain questionnaire of the International Index of Erectile Function IIEF).~      This is an interventional study~   "
30366|NCT03169569|"~     Endoscopic submucosal dissection (ESD) for superficial gastric neoplasm is minimally invasive~     and achieves curative resection with an acceptable rate of adverse events. Although the~     safety of ESD has been demonstrated, the procedure is associated with a substantial risk of~     adverse events, including bleeding, perforation, and stricture.~      Post-ESD bleeding is the most frequent adverse events and the incidence of post-ESD bleeding~     in previous studies ranges from 1.8% to 15.6%. Several studies identified that antithrombotic~     agents and large resection size were strong risk factors for post-ESD bleeding. Moreover, the~     incidence of bleeding in high-risk patients has been reported to be as high as 61.5%,~     depending on the definition of high-risk patients. The number of patients at high risk for~     post-ESD bleeding is increasing worldwide. In addition, as the indications for ESD have been~     expanding, more patients with large lesions undergo ESD. Therefore, it is important to~     prevent post-ESD bleeding in high-risk patients.~      Although several previous studies have attempted to prevent post-ESD bleeding using surgical~     material, there is no definite prophylactic treatment to prevent re-bleeding after ESD. To~     date, coagulation of remnant vessels on the post-resection ulcer surface and administration~     of a proton pump inhibitor (PPI) after ESD are practical methods to prevent post-ESD~     bleeding.~      Polysaccharide hemostatic powder (Endo-Clot™) is a new topical hemostatic method recently~     used for non-variceal upper gastrointestinal bleeding. This study aimed to identify the~     efficacy of hemostatic powder in preventing post-ESD bleeding in high-risk patients. This is~     a multicenter, prospective, randomized study.~   "
30367|NCT03169556|"~     Among advanced intubation equipment for difficult intubation, a lighted stylet (lightwand) is~     a widely used equipment in cervical immobilized patients. However, a lightwand, which is used~     blind, is difficult to make midline positioning and can increase airway complications and~     hemodynamic changes. In contrast, videolaryngoscope can view vocal cord indirectly through~     camera, however, it requires cervical movement. Therefore, investigator hypothesized that the~     combined use of video-laryngoscope and lightwand for intubation can improve the efficacy of~     intubation compared to the use of lightwand alone in cervical immobilized patients.~   "
30503|NCT03167775|"~     Clinical Trial of Elemene Injection/Elemene Oral Emulusion in Combination With the Best~     Supportive Treatment in the Treatment of Advanced Primary Liver Cancer~   "
30368|NCT03169543|"~     From 40 to 60% of patients with depression experience a rapid and significant improvement of~     mood with one night of sleep deprivation (SD). The neural mechanisms underlying this effect~     have not been elucidated. Recent advances in functional neuroimaging have provided new~     opportunities to investigate state changes in regional brain function, along with a better~     understanding of the neural networks affected by depression and SD. Here we propose to study~     a group of N=48 antidepressant-free male and female patients with current depression symptom~     and N=12 healthy controls with no history of mood disorders before and after SD to provide~     mechanistic insight into the neural substrates underlying the antidepressant effects of SD.~     We hypothesize that SD-induced concurrent functional activity and connectivity changes in~     multiple brain networks related to different depressive symptom dimensions including emotion~     regulation, attention, arousal, self-referential, and reward processing will underlie the~     rapid and transient antidepressant effects of SD. Using an ABA design, multimodal brain~     imaging along with more traditional electroencephalographic (EEG) and neurobehavioral testing~     data will be acquired at baseline after normal sleep, during one night of total SD, and after~     one night of recovery sleep using a 5-day in laboratory protocol during which subjects will~     be continuously monitored by trained staff.~   "
30369|NCT03169530|"~     The Moderate Alcohol and Cardiovascular Health Trial (MACH15) is a multicenter, worldwide,~     randomized clinical trial of ~15 gm of alcohol daily versus abstention, using a balanced~     parallel design and single-blind assessment of all outcomes among approximately 7,800~     participants aged 50 years and older with advanced cardiovascular risk. Intervention will~     average 6 years in duration with a common close-out date. Following recruitment and~     pre-screening, participants will attend a screening visit followed by a two-week abstention~     washout period, a baseline visit and randomization, and subsequent visits at 3 months, 6~     months, 12 months, and then annually until close-out.~   "
30370|NCT03169517|"~     Laser speckle contrast imaging (LSCI) allows real-time, non-invasive, quantitative~     measurements of regional blood flow. The aim of this prospective observational study was to~     evaluate the blood flow changes by LSCI after peripheral nerve block and determine whether~     this novel optical technique can be used as a reliable indicator of successful blocks.~   "
30371|NCT03169504|"~     This study aims to compare the efficacy of three therapies for chronic obstructive pulmonary~     disease (COPD) patients: one, conventional drug based on Global Initiative for Chronic~     Obstructive Lung Disease (GOLD) 2017 and Chinese Medical Association Guidelines; another,~     acupuncture, an important part of traditional Chinese Medicine; and finally, the combination~     of conventional drug and acupuncture, and then determine which therapy is the most suitable~     for patients with COPD.~   "
30372|NCT03169491|"~     Obstructive sleep apnea syndrome (OSAS) in children has high prevalence and severe~     complications, and its first line of treatment (adenotonsillectomy) has risk of~     complications. Even though the use of presurgical CPAP seems logical due to its effects in~     adults, it must be studied in children due to the different physiopathology and adherence.~     One non-invasive way of study the effect is via acoustic pharyngometry, which can measure the~     anatomical site of obstruction. The post-surgical anatomical changes could correlate with a~     persistent OSAS, which would be helpful in selecting those patients who require a post~     surgical sleep study. The main goal of the study is to cuantify the changes in the~     oropharyngeal volume via acoustic pahryngometry after CPAP use, and also the changes after~     adentonsillectomy in children.~   "
30373|NCT03169478|"~     Transcervical resection of submucous myomas (TCRM) is nowadays considered necessary if it is~     associated with infertility or miscarriage or menorrhagia. Nevertheless, one possible risk of~     hysteroscopic myomectomy is the formation of intrauterine adhesion (IUA) at the site of~     resection. The development of IUA arising from trauma to the basalis layer of the endometrium~     during hysteroscopy can result in infertility, recurrent miscarriages, amenorrhea,~     dysmenorrhea, or abnormal placentation.~      Several measures have been proposed in an effort to decrease the formation of post-surgical~     intrauterine adhesions. Additionally, physical barriers such as balloon catheters or~     intrauterine devices have been used in the postoperative period. Despite years of studies~     evaluating prevention strategies for intrauterine adhesion formation after operative~     hysteroscopy, it is still unclear which strategy is most effective because there has never~     been any formal properly powered randomized, control trial to examine the efficacy of the~     various methods used to prevent adhesion reformation.~      In this prospective, randomized, controlled study, the investigators wish to examine the~     efficacy of intrauterine balloon dilatation therapy in the early postoperative period in~     preventing adhesion formation after transcervical resection of submucous myomas.~   "
30374|NCT03169465|"~     Patients with posterior calcaneal deformity may presented by many clinical data associated~     with retrocalcaneal bursitis which occurs due to the deformity this clinical complaining~     include pain and swelling in the back of the heel.~      Many treatment choices available of this deformity with low level of response to conservative~     treatment which includes medical treatment , physiotherapy and corticosteroids injection.~     surgical treatment in cases of HAGLUND deformity is the treatment of choice including either~     endoscopic or open surgical approach for this deformity .~   "
30375|NCT03169452|"~     Noninvasive ventilation is increasingly used method of respiratory management in both the~     emergency room and critical care. Noninvasive ventilation delivers mechanically assisted~     breaths without the placement of an artificial airway and has become an important mechanism~     of ventilator support inside and outside the intensive care unit.~      Noninvasive ventilation is further subdivided into negative pressure ventilation which is the~     iron lung, first used in 1928 and the Hayek oscillator, is a more recently designed to~     provide negative pressure during inspiration and positive pressure during expiration.~     Noninvasive positive pressure ventilation can be used as continuous positive airway pressure~     or bi-level positive airway pressure.~   "
30376|NCT03169439|"~     Irreversible electroporation (IRE) is a novel non-thermal ablation modality with promise for~     revolutionizing the treatment for local solid tumors.~      With the growing demand for alternative and less invasive treatments for localized tumors,~     the investigators have seen the development and investigation of several tissue ablation~     modalities, including radiofrequency ablation (RFA), microwave ablation, and cryoablation.~     Although these modalities have been efficacious, they have some disadvantages owing to their~     reliance on thermal energy for creating cell death.~   "
30379|NCT03169400|"~     The project will be structured in 3 main parts:~        1. Effect of sera of ESRD patients on HD using Theranova dialyzer on high-Pi induced~          vascular calcification in an in vitro model of rat VSMCs.~        2. Effect of sera of ESRD patients on HD using Theranova dialyzer on oxidative stress~          pathways in an in vitro model of rat VSMCs vascular calcification.~        3. Study of RNA sequencing, transcriptome analysis gene expression of time course high-P~          challenged VSMCs studying the effect of sera of ESRD patients on HD using Theranova~          dialyzer~   "
30380|NCT03169387|"~     Introduction: Cardiovascular diseases are the leading cause of death in the world, thus,~     rehabilitation programs are essential to improve symptoms and reduce mortality. Virtual~     reality presents itself as a new alternative of therapeutic resource, stimulating the~     practice of physical activity through interaction between man and machine, based on the use~     of games and virtual environments. Objective: To compare the body composition of individuals~     with cardiovascular diseases submitted to conventional cardiac or virtual reality~     rehabilitation. Methods: Twenty-four individuals with cardiovascular diseases, divided into a~     conventional rehabilitation group (GRC) or virtual reality rehabilitation group (GRV), will~     be evaluated, and undergo a rehabilitation program for a period of 8 weeks, with two weekly~     sessions lasting 60 minutes. For the GRV training, the Xbox 360® from Microsoft with Kinect™~     will be used with the games YourShape™ (Fitness Evolved) and Dance Central 3™. For the GRC~     training, treadmills (embreex) will be used to perform the aerobic training and free weights~     and weight training equipment to perform the resistance training. Food frequency will be~     evaluated by means of the Food Frequency Questionnaire, food consumption by the 24-hour food~     recall, body composition by bioimpedance, and functional capacity by the six-minute walk~     test. For analysis of data normality the Shapiro Wilk test will be applied. For paired~     analysis, the Student's T test will be performed in case of normal distribution or the~     Wilcoxon test for variables that do not follow Gaussian distribution. The intergroup~     comparisons will be analyzed through absolute variation before and after the interventions~     and the unpaired Student's T test or Mann Whitney test applied according to the normality of~     the data. The level of significance adopted will be 5%.~   "
30381|NCT03169374|"~     The purpose of this study is to investigate the safety and feasibility of virtual reality for~     anxiety treatment in mechanically ventilated patients.~   "
30382|NCT03169361|"~     The purpose of this study is to evaluate the safety of NINLARO in participants with~     relapsed/refractory multiple myeloma in daily clinical practice.~   "
30383|NCT03169348|"~     Autoimmune thrombocytopenic purpura is an immunological disorder characterized by increased~     platelet destruction due to presence of anti-platelet antibodies. Hepatitis C virus~     infection, which is one of the most common chronic viral infections worldwide, may cause~     secondary chronic immune thrombocytopenic purpura. It seemed to play a pathogenic role in~     autoimmune thrombocytopenic purpura. Moreover, the successful response (negative hepatitis C~     virus - ribonucleic acid) to tapered steroids and antiviral therapy was useful to revert~     thrombocytopenia~   "
30384|NCT03169335|"~     The objective of this study is to assess the similarity between QL1101 and Avastin®~     respectively combined with chemotherapy in terms of efficacy and safety in patients with~     non-squamous non-small cell lung cancer. The study intends to include first-line patients~     with non-squamous non-small cell lung cancer, and uses QL1101 combined with basic~     chemotherapy CP (paclitaxel + carboplatin). The regimen is consistent with the usage and~     dosage of Avastin® at home and abroad indicated for the treatment of non-squamous non-small~     cell lung cancer.~   "
30385|NCT03169322|"~     Studies reveal association between dry conditions and decreased healing in wounds or any~     treatment. From these studies, it can be hypothesized that healing in mouth breathers after~     scaling and root planing in terms of bleeding on probing, gingival index, plaque Index,~     clinical attachment level, probing depth may not show as much improvement as in case of nose~     breathers. No study has been conducted till date to find effect of scaling and root planing~     in periodontitis patients among mouth breathers and nose breathers.~   "
30386|NCT03169309|"~     Brain Entrainment Technology (BET), also known as Binaural Beat Technology (BBT); is an~     auditory-neurophysiologic technique which uses auditory tones (often embedded in music,~     nature sounds or white noise) dichotically via stereo headphones to manipulate brainwave~     activity in turn affecting the listener's mental, physical and/or emotional state. Although~     this technology is widely marketed to the general public and can be found free in on the~     internet, only a hand full of scientific studies have shown its efficacy. This study is a~     follow-on study to the Sound Mind Warrior (SMW) Study (ClinicalTrials.gov [NCT02328690])~     conducted 2012-2015 which assessed the efficacy of the technology (in the theta brainwave~     frequency) on the cardiovascular stress response in a group of service members with complaint~     of chronic stress. This study will now assess BET (in the delta brainwave frequency) on~     sleep quality in a population of military healthcare beneficiaries with complaint of poor~     sleep quality.~   "
30387|NCT03169296|"~     Myelodysplastic syndrome (MDS) is a group of clonal haematopoietic stem cell disorders~     characterized by ineffective haematopoiesis leading to cytopenia, with a significant risk of~     progression to acute myeloid leukaemia (AML). Progression to AML and resistance to~     hypomethylating agents (HMA) are important unmet clinical needs. The pathophysiology of MDS~     and its progression to AML involve cytogenetic, genetic and epigenetic aberrations, and hence~     better understanding of the molecular landscape of MDS has important clinical implications.~     Also, future treatment strategies for MDS may involve exploitation of genetic information in~     designing more effective therapy encompassing single agents or combinatorial approaches.~      The proposed cohort study aims to establish a registry of clinical and genomic registry of~     MDS and secondary AML in Asian patients, which allows the establishment of the mutational~     profile of patients and prognostic model for survival, as well as exploration of treatment~     strategies and prediction for treatment response.~   "
30388|NCT03169283|"~     This project will assess the effects of the macro-nutrient make-up of morning food intake on~     cognitive performance using visual analog scale (VAS) measures, behavioral tests, and~     advanced high-density electrophysiological techniques (256-channel recordings). Two~     Isocaloric cereal products will be tested and compared to determine if measures of cognitive~     performance as well as satiety will change after consumption.~   "
30400|NCT03169127|"~     The present clinical trial randomized will be to assess the link between the different~     haplotypes of CYP2C8 and CYP2C9 genes and the clinical efficacy of ibuprofen after lower~     third molar extractions. Onset, duration of postoperative analgesia, duration of anesthetic~     action on soft tissues, intraoperative bleeding, hemodynamic parameters, postoperative mouth~     opening and wound healing at the 7th postoperative day were evaluated. For this purpose, 200~     healthy volunteers underwent removal of one lower third molar, under local anesthesia with~     articaine 4% (1:200,000 adrenaline) will be genotyped and phenotyped for these genes and~     their postoperative records with all data collected will be compared with the haplotypes~     found in the Brazilian population.~   "
30389|NCT03169270|"~     The current protocol is developed in the context of a large Research and Innovation (R&I)~     program aiming the promotion of daily life physical activity in chronic patients registered~     at clinicaltrials.gov (NCT02976064) and approved by the ethical committee of the Hospital~     Clinic de Barcelona (HCB/2016/0883). The project is partly supported by the Smart Innovation~     Strategies promoted by the EU Commission (COMRDI15-1-0016). Specifically, the protocol uses~     retrospective information collected between 2005-2008 as part of the EU project Biobridge~     (LSHG-CT-2006-037939).~      The aims of the current analysis of the retrospective information are 1) to assess~     training-induced changes in muscle oxygen saturation (StO2) assessed by near-infrared~     spectroscopy (NIRS) during constant-work rate cycling exercise (CWRE) as a useful marker of~     the effects of training at limb muscle level in patients with chronic obstructive pulmonary~     disease (COPD), and 2) to further explore underlying mechanisms of skeletal muscle~     dysfunction as a characteristic systemic effect of COPD, potentially modifiable with~     preventive interventions as endurance muscle training.~      Methods: Incremental exercise (VO2 peak) and CWRE at 70% baseline peak work rate, before and~     after 8-week of endurance exercise training, were done in healthy sedentary subjects and COPD~     patients. NIRS was used to assess StO2 in the left vastus internus during the CWRE (before~     an after training program) (objective 1); and blood samples and muscle biopsies of the~     quadriceps were obtained at rest (before an after training program) (objective 2).~   "
30390|NCT03169257|"~     Background Childhood obesity has been related to an impaired cardiovascular structure and~     function. Aims of this study will be to evaluate early cardiovascular abnormalities in a~     large population of obese children and adolescents compared with a normal weight counterpart,~     to investigate the potential association with insulin resistance (IR), serum uric acid (sUA),~     metabolic syndrome (MetS), plasmatic markers of inflammation and oxidative stress and~     adipokines, to evaluate changes in cardiovascular dysfunction after 6 and 12 months of a~     behavioral treatment (isocaloric Mediterranean balanced diet plus daily aerobic physical~     activity).~      Subjects and methods This was a single-center case-control study. Eighty obese (OB) subjects~     (6-16 years) and 20 normal weight (NW) matched controls were consecutively recruited. In the~     whole population we will perform an anthropometric and a cardiovascular assessment. OB~     patients will also undergo an OGTT and biochemical evaluations. In the OB group, all these~     evaluations will be performed at baseline and after 6 (T6) and 12 months (T12) of diet plus~     aerobic training.~   "
30391|NCT03169244|"~     The present proposal is an innovative and translational clinical trial derived from exciting~     preclinical findings to test the hypothesis that treatment with the melanocortin activator~     bupropion can reduce binge drinking in humans. Furthermore, pilot data on moderating effects~     of coexisting nicotine use on the efficacy of bupropion for binge drinking population will be~     obtained. Evidence for an efficacy signal with good tolerability with this FDA approved~     medication would form the foundation to conduct a well-powered Phase II b trial. The~     development of an effective pharmacotherapy for binge drinking would be a significant~     clinical advance.~   "
30392|NCT03169231|"~     This is a randomized, placebo-controlled, double-blind, parallel arm, multi-center Phase 2b~     study.~   "
30393|NCT03169218|"~     The purpose of this study was to evaluate pain and function after mirror therapy as well as~     level of catastrophism in bilateral carpal tunnel syndrome patients~   "
30394|NCT03169205|"~     The aim of this work is to demonstrate the variation of Diabetes mellitus either preexisting~     or gestational Diabetes mellitus among pregnant ladies in our localities, detect maternal &~     fetal complications and to predict the risk factors for poor maternal, fetal & neonatal~     outcomes~   "
30395|NCT03169192|"~     The study will be conducted at Assiut university children hospital and it will include~     patients with history of repeated fractures due to mild or irrelevant trauma.~      Diagnosis will be established by biochemical tests, bone survey to exclude secondary causes~     followed by Dual Energy absorbiometry scan to detect bone density of selected cases then~     confirm our diagnosis by detection of gene mutations of Osteogenesis imperfecta during one~     and half year duration with starting zoledronic acid therapy during this duration.~   "
30396|NCT03169179|"~     Policing is an increasingly sedentary occupation and high levels of physical and~     psychological morbidities are reported by officers and staff. Wearable fitness technology may~     be a feasible intervention to promote physical activity and improve health.~      This study aims to assess the feasibility and acceptability of introducing wearable fitness~     technology (Fitbit™ activity monitors linked to the 'Bupa Boost' smartphone app) as a~     motivator for increasing physical activity within the police force. Additional aims are to~     and to assess the potential impact of the intervention on physical activity, sedentary time,~     health and wellbeing, stress, sickness absence and self-perceived productivity, and to~     explore which motivational strategies (e.g. individual goal-setting vs. social competitions)~     are most acceptable and potentially effective and for which groups of staff.~      A single-group, before and after, mixed methods exploratory trial will be conducted.~     Approximately 180 police officers and staff from two sites (Plymouth Basic Command Unit and~     North Dorset) will be recruited to take part. Participants will use the technology for 12~     weeks initially followed by a further five months of optional use. A combination of~     questionnaire surveys, interviews and analysis of staff absence records will be used.~      Data will be collected pre-intervention, mid-intervention (6 weeks), post-intervention (12~     weeks) and follow-up (8 months). Primary outcomes are change in objectively recorded step~     count, self-reported physical activity and sedentary time. Secondary outcomes include general~     health and wellbeing, perceived stress and productivity, sickness absence, engagement with~     the intervention and perceived usability and usefulness.~      This study will add to our understanding of the feasibility and acceptability of mobile~     fitness technology in a specific workplace setting, and inform a potential larger trial~     within the police force.~   "
30397|NCT03169166|"~     This is a prospective comparative randomized controlled trial investigating the effect of two~     GnRH agonist trigger protocols on the ongoing pregnancy rate in hyper-responder women~     undergoing assisted reproductive technology.~   "
30398|NCT03169153|"~     The purpose of this study is to compare AIR OPTIX® plus HydraGlyde (AOHG) contact lenses to~     ACUVUE® VITA® (VITA) contact lenses for total lipid uptake (total of surface and bulk uptake)~     after 30 days of wear by high lipid depositors.~   "
30399|NCT03169140|"~     The purpose of this study is to compare the effect of a combination of separate therapies of~     Biofreeze® and TheraBand Kinesiology Tape to advice on acute pain, disability and fear~     avoidance among low back patients over a 1-week period of time.~   "
30420|NCT03168867|"~     The purpose of the study is to conduct a multicenter, randomized effectiveness trial of The~     3Ms. The proposed study will use an effectiveness-implementation Hybrid 1 design. In this~     design, the primary goal is to determine whether an intervention works in a real-world~     setting, but the design also answers secondary questions such as the relationship between~     treatment dose and treatment outcome and what factors affect the actual delivery of the~     intervention in the clinics (staff burden, workflow interference etc).~   "
30401|NCT03169114|"~     The RIPASA score is a Clinical Prediction Rule (CPR) for the diagnosis of acute appendicitis.~     Since its inception in 2009, the RIPASA score has been validated in various population in~     healthcare institutions around the world and reported significantly higher sensitivity and~     specificity when compared to Alvarado score. RIPASA score ranges from 3 to 16.5 with those~     having a score of less than 7 having a low probability of acute appendicitis and those with a~     score of 7.5 having a high probability of acute appendicitis.~      There has been a trend in the past decade on non-operative management of early-uncomplicated~     acute appendicitis (EuAA) with antibiotic therapy. This antibiotic non-operative management~     strategy (AMS) has been reported to work in children, thus avoiding unnecessary emergency~     operation. In adults presenting with early-uncomplicated acute appendicitis, this management~     pathway is still uncertain and most randomized controlled trials (RCT) and meta-analysis have~     not been able to show significant benefit of AMS over surgery management strategy (SMS),~     partly due to variable treatment efficacy, high recurrence rate within a year and a lack of~     agreement of whom would constitute a group of EuAA.~      The working hypothesis of this study is that RIPASA score as a Clinical Prediction Rule, can~     determine a group of patients with a diagnosis of EuAA, based on the range of scores (RIPASA~     score 7.5 - 11.5), who will benefit from an AMS rather than SMS, leading to improve patients'~     outcomes through a significant reduction in negative appendicectomy rate, shorter length of~     hospital stay, reduce post-operative complications and changing physician behavior in~     managing this group of patients to an AMS rather than SMS and ultimately financial cost~     savings.~      The primary specific aim of this study is to compare AMS with SMS in patients with EuAA in a~     prospective non-inferiority RCT. Secondary specific aims are to determine the range of RIPASA~     score that can define a group of patients with EuAA, step 3 validation of RIPASA score as a~     valid CPR and improve patient outcomes in terms of reducing unnecessary negative~     appendicectomy rate, hospital stay and complications arising from such surgery, and~     ultimately financial cost savings.~   "
30402|NCT03169101|"~     This study tests whether withdrawal-related cognitive deficits increase smoking relapse among~     HIV-infected (HIV+) vs. HIV-uninfected smokers (HIV-). Adult smokers (N=300; 150 HIV+, 150~     HIV-) will complete 2 sessions to assess cognition (24h abstinence vs. smoking-as-usual;~     order counterbalanced; weeks 0-2). Subjects will then receive smoking cessation counseling~     and open label transdermal nicotine (weeks 3-12). Outcomes are: 1) cognition; and 2)~     abstinence rates at the end-of-treatment.~   "
30403|NCT03169088|"~     Unhealthy lifestyles are major factors contributing to chronic conditions that impose a huge~     financial burden in EU healthcare systems. Unfortunately, the communication of Public Health~     failed to influence consumer to change their habits.~      In this study, the aim is to evaluate the impact of a regular monitoring during 1 year on~     wellbeing and dietary habits in healthy volunteers.~      This study follows the pilot study cook to health and is intended to confirm the results~     obtained by the tools used in C2H, in a larger population (25-50 years)~   "
30404|NCT03169075|"~     This phase II-III study will randomize (2:1) patients starting first-line OTT for metastatic~     cancer between an individualized SPEP supervised by a personal coach, and recommended~     physical exercises via a booklet. Eligible patients will have received ≤2 lines of metastatic~     chemotherapy, ECOG PS ≤2, controlled pain (VAS <3/10), and life expectancy ≥3 months.~   "
30405|NCT03169062|"~     The purpose of this study is to propose a new method for evaluating coronary artery calcium~     scores (CACS) in individuals with coronary artery disease.~   "
30406|NCT03169049|"~     The purpose of this study is to determine whether the transcutaneous application of~     unmodulated high frequency alternating currents could produce a quickly conduction block of~     peripheral nerve.~   "
30407|NCT03169036|"~     Melanoma is the most dangerous skin cancer and is becoming commoner, largely due to increased~     foreign holidays and use of sun-beds. Melanoma usually begins as a new or changing mole. If~     it is picked-up quickly enough it can be removed in a simple operation and effectively cured.~     GPs can do this operation and many are highly experienced and skilled in minor skin surgery.~     However, guidelines written by hospital specialists insist that all patients who might have a~     melanoma should not be treated by GPs, but should be referred to hospital. This contrasts~     with Australia, where melanoma is commoner and initial treatment by GPs is standard practice.~     This creates several potential problems. First, melanoma can be difficult to diagnose. Many~     moles that do not look concerning based on checklists do turn out to be melanoma, and the~     opposite frequently occurs too, moles that look worrying at initial examination are not~     melanoma. Second, people are becoming more skin aware and GPs are checking moles much more~     often. Sensibly many of these patients are being sent to hospital for a check, although most~     will not have melanoma. Third, as a result hospital skin clinics and minor surgery lists are~     becoming very busy and waiting times are ever increasing. Fourth, the many people who have a~     melanoma that is not clinically obvious are waiting an increasingly long time to have it~     diagnosed and treated in hospital, and this could actually mean that melanoma has more chance~     to spread while they wait. The investigators conducted studies on 1200 people diagnosed with~     a melanoma in Northeast Scotland between 1991 and 2008 and found that 20% of these people had~     had their melanoma diagnosed and first treated by their GP. These patients were no more~     likely to receive improper treatment than those that had been referred to hospital. Also~     people who had had their melanoma cut out by a GP were no more likely to die from melanoma,~     and they actually required less hospital visits afterward. This suggests that the guidelines~     could be changed to allow GPs to treat suspicious moles. The investigators think this will be~     better for patients and the NHS in the long-run. However, the investigators cannot recommend~     changes to the guidelines on the basis of local research. For this reason, the investigators~     wish to extend the study using data from 18,000 patients diagnosed with melanoma from across~     Scotland. The results of this inclusive study will inform how the health service should deal~     with the growing problem of suspicious moles in the future.~   "
30408|NCT03169023|"~     This proposal will pilot a weight management program for patients with endometrial cancer,~     the cancer most associated with obesity. If successful, this pilot could be expanded to~     include obese women with other gynecologic cancers (ovarian and cervical) and could be~     expanded and adapted for use not only upon completion of treatment, but during chemotherapy~     or radiation. Furthermore, other obstetricians and gynecologists could use this strategy for~     obese women as a practical cancer prevention strategy for obesity-associated cancers.~   "
30409|NCT03169010|"~     The knowledge on the rare type of pulmonary hypertension which can not be explained by left~     heart disease, respiratory disease or congenital heart disease is very limited. Investigators~     aim to setup a national registration study for the rare type of pulmonary hypertension, to~     understand the natural history, survival, progression, genetic and environmental~     contributions to disease.~   "
30410|NCT03168997|"~     The aim of this study is to investigate whether there will be any efficacy difference of~     Memantine treatment in different cognitive severity AD patients stratified with BPSD~   "
30411|NCT03168984|"~     The purpose of the study is to evaluate the pharmacokinetics, safety and tolerability of~     UCB0942 in Japanese and Caucasian subjects.~   "
30412|NCT03168971|"~     The purpose of this study is to examine the preliminary efficacy of a telephone-administered~     cognitive-behavioral therapy intervention for anxiety in older adults (65 years and older)~     with cancer and their primary informal caregiver. This study will examine the impact of the~     intervention on patient and caregiver anxiety (primary outcome) and depression, distress, and~     quality of life (secondary outcomes) relative to a usual care control condition.~   "
30469|NCT03168217|"~     This study aims to identify phenotypic groups of patients with periodontitis by applying a~     cluster analysis.~   "
30549|NCT03167164|"~     This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination~     therapy in subjects with MCC who have progressed on or after anti-PD-L1 therapy.~   "
30413|NCT03168958|"~     Patients undergoing cardiac surgery often experience moderate to severe pain in the early~     postoperative period. A number of methods have been used to help control pain after surgery;~     however, each of these techniques adds additional costs and risks. A simple and effective way~     to decrease this pain is to administer a long-acting opioid in the operating room. Methadone~     is a opioid that can produce analgesia (pain relief) that lasts up to 48 hours when given in~     large doses (0.3 to 0.4 mg/kg). Previous studies have demonstrated that both pain and~     requirements for analgesic medications are significantly reduced for up to three days after~     surgery if methadone is given at induction (the start) of anesthesia. In the study that was~     performed at Evanston Hospital, cardiac surgical patients who were given methadone also~     appeared to feel better after surgery compared to those given a standard or typical~     intraoperative opioid. The aim of this randomized clinical trial is to determine whether~     overall quality of postoperative recovery can be enhanced if methadone is given in the~     operating room. Quality of recovery will be determined by using a validated scoring system,~     the QoR 40, which will be given to patients to complete on the first three days after~     surgery.~   "
30414|NCT03168945|"~     TB kills most people with HIV in Africa. TB is out of control. Radically different approaches~     to deal with the disease is therefor needed. It is known that intensified case finding works~     in high HIV prevalence environments. However, the poor performance of conventional~     diagnostics makes the strategy costly and unpalatable for policy makers. If it can be shown~     that a package of new diagnostic technologies significantly enhances ease and speed of~     diagnosis, and time to treatment initiation when using intensified case finding, this will~     usher the way for further studies and policy adjustments to tackle TB. Thus, the work, if~     found to be useful, could have major policy implications~      The purpose of this study will be to determine the diagnostic yield, impact and feasibility~     of community-based intensified TB case finding using symptom screening, point-of-care TB~     testing (Xpert Omni), point-of-care HIV testing and CD4 count (Alere PIMA), if HIV-infected,~     together with a clinic-based diagnostic package (sputum smear microscopy, MGIT sputum~     culture, and digital chest radiograph). Additionally, the study will assess the~     infectiousness of previously undiagnosed TB cases in the community using cough aerosol~     sampling technology (CASS) and will determine the genomic, transcriptomic and lipidomic~     profile of TB isolates from patients undergoing CASS sampling. The cost-effectiveness of~     using a novel TB diagnostic platform (Xpert Omni) for intensified case finding compared to~     conventional methods will also be evaluated.~      ~6000 people will be screened to enrol 600 participants with suspected TB. It is expected~     that using the GeneXpert® Omni POC mobile clinic of 2- to 3-person team of healthcare workers~     in an inexpensive panel van will substantially reduce the time to treatment initiation, and~     the proportion of individuals initiating and completing TB treatment. Investigators will also~     review and follow up Household contacts of active TB participants.~      As part of the study investigators will also contribute data and specimens to the RePORT~     consortium (Regional Prospective Observational Research for Tuberculosis), that aims to~     create a multinational bank with the primary objective of providing specimens and data to~     RePORT consortia biomarker researchers and their collaborators over the next decade to~     achieve a better understanding of the prognosis of TB disease; and the pathogenesis of~     progression from TB exposure to disease.~   "
30415|NCT03168932|"~     Gyrogenesis is an ontogenic process that transforms the smooth (lissencephalic) cortex toward~     its mature, convolved (gyrencephalic) state. A tortuous, branching and deepening pattern of~     sulci and fissures outlines for a well-developed cortex.~      The aim of this study is to find an algorithm that can detect the sulci in ultrasound images~     of fetus' brain and measure the length of it. This algorithm can be used for research demands~     like learning the development of the brain from embryo stages until the birth of the baby~   "
30416|NCT03168919|"~     The overall goal of this study is to determine if quantitative imaging techniques can be used~     to detect dynamic changes of morphology and different physiologic properties of the tumor~     during and after completion of radiation treatment and to predict site and time of radiation.~   "
30417|NCT03168906|"~     This is a multicenter, Phase 2b, randomized, double-blind, placebo-controlled, two-arm,~     parallel-group efficacy and safety study of NEOD001 as a single agent administered~     intravenously in adults with AL amyloidosis who have a maintained hematologic response to~     their most recent treatment for AL amyloidosis (e.g., chemotherapy, autologous stem cell~     transplant [ASCT]) and have persistent renal dysfunction.~   "
30418|NCT03168893|"~     Deep brain stimulacion (DBS) clinical study in the subcallosal cingulate (CSG) and accumbens~     nucleus (NAc) for 8 patients with treatment-refractory, cronic and severe anorexia nervosa~     (AN) patients. The main objective is to show efficacy and safety. Studies show that SSG and~     NAc are strategical targets in the pathophysiology and the hypothetical surgical treatment in~     AN patients. The patients distribution (4 patients in each target) it will made by the AN~     type and the comorbidity associated, the reasons are: 1- It is well known the comorbidity~     treatment imoportance in the AN evolution, 2- The two differentes types of AN have differents~     clinical behaviour and prognosis, 3- Studies show efficacy in TOC and DM patients with NAc~     DBS and in DM patients with CSG DBS. The main variable is BMI. After a 6 months stabilization~     evaluation phase will be followed (only in patients that have increase 10% BMI) by a~     double-bind, crossover phase, where patients will receive 3 months with stimulation turned on~     and 3 month with turned off. All patients will have a 12 months follow up. The study~     secondary objectives are to know the relation btween the stimulacion answer (increase 10%~     BMI) and the differents variables, specially AN type, associated cormobidity, selected target~     and preoperative MRI tractography study.~   "
30419|NCT03168880|"~     Triple-negative breast cancer is a subtype of breast cancer that is clinically negative for~     expression of estrogen and progesterone receptors (ER/PR) and HER2 protein. It is~     characterized by its unique molecular profile, aggressive behavior, distinct patterns of~     metastasis, and lack of targeted therapies. Although not synonymous, the majority of~     triple-negative breast cancers carry the basal-like molecular profile on gene expression~     arrays.~      Although sensitive to chemotherapy, early relapse is common and these cancers show a~     predilection for visceral metastasis, including brain metastasis. Targeted agents, including~     epidermal growth factor receptor (EGFR), vascular endothelial growth factor (VEGF), and poly~     (ADP-ribose) polymerase (PARP) inhibitors, are currently in clinical trials and hold promise~     in the treatment of this aggressive disease.~      Multiple independent data sets have revealed that the triple negative type of breast cancer~     carries a poor prognosis. It is unclear whether the poor prognosis of triple negative breast~     cancer is due to poor therapy options or inherent aggressiveness. Given their triple negative~     receptor status, these tumors are not amenable to conventional targeted therapies for breast~     cancer, such as endocrine therapy or trastuzumab, leaving only chemotherapy in the~     therapeutic armamentarium.~      Patients on metformin showed a 30-40% protection against all forms of cancer. Recent pilot~     studies carried out using population registries raise the possibility that metformin may~     reduce cancer risk and/or improve cancer prognosis. One showed an unexpectedly lower risk of~     a cancer diagnosis among diabetics using metformin compared with a control group of diabetics~     using other treatments ; another showed lower cancer-specific mortality among subjects with~     diabetes using metformin compared with diabetics on other treatments. Metformin is a~     biguanide known to be an insulin sensitizing agent which promotes reduced circulating insulin~     and glucose levels in hyper-glycaemic and hyper-insulinaemic patients. Metformin activates~     the AMP dependent kinase, attenuates insulin and IGF-1 stimulated proliferation in breast~     cancer cells and a general decrease in protein synthesis in vitro. Western blot analysis~     indicated that metformin stimulates AMPK phosphorylation in a dose-dependent manner. AMPK~     activation is associated with decreased phosphorylation of mTOR and S6 kinase. While~     metformin reduces breast carcinoma cell proliferation both in vitro and in vivo, the~     activation of AMPK leads to significant VEGF production, angiogenesis and tumor progression.~     This must be taken into consideration when it is applied in as a therapeutic regimen.~   "
30421|NCT03168854|"~     This Phase 1 trial will include 16 subjects in Study Arms 1 and 2 who will receive the GAP3KO~     vaccine administered by the bite of approximately 200 infected A. stephensi mosquitoes in a~     controlled clinical environment and 12 CHMI infectivity controls (six for each of the two~     CHMIs). The ten subjects in Arm 1 will each receive five vaccinations, with the first four~     vaccinations given four weeks apart and the fifth vaccination given eight weeks after the~     fourth vaccination, for a maximum cumulative dose of 1000 GAP3KO bites per subject and~     scheduled vaccinations will be given to all Arm 1 subjects on the same day. The six subjects~     in Arm 2 will receive three vaccinations, with the second vaccination given four weeks after~     the first vaccination and the third vaccination given eight weeks after the second~     vaccination, for a maximum cumulative dose of 600 GAP3KO bites per subject. The scheduled~     vaccinations will be given to all Arm 2 subjects on the same day. The first CHMI will be~     given at four weeks after the last vaccination for subjects in Study Arms 1 and 2 and will~     include six infectivity controls. The second CHMI will be given 26 weeks (six months) after~     the first CHMI and will include subjects in Study Arms 1 and 2 who did not have documented~     malaria infection following the first CHMI and six new infectivity controls. To allow the~     first and second CHMI administrations to be given concurrently to subjects in Study Arms 1~     and 2, subjects in Study Arm 2 will initiate the GAP3KO series on the day that Study Arm 1~     subjects receive their third vaccination. The second vaccination for Study Arm 2 subjects~     will be given four weeks later, on the day that Study Arm 1 subjects receive their fourth~     vaccination, and both groups will receive their last vaccination eight weeks later. Subjects~     will be observed for adverse events for at least 60 minutes after each GAP3KO administration.~     Solicited local and systemic AEs will be recorded on a memory aid Subjects will be monitored~     for possible breakthrough peripheral parasitemia . Positive tests will be followed by repeat~     testing as soon as possible and with clinical safety labs.Four weeks after the last GAP3KO~     administration, all subjects who completed the immunization phase (up to 16) and a group of~     six malaria-naïve infectivity controls will be challenged on the same day with wild-type P.~     falciparum NF54 sporozoites. On the day of challenge, subjects will receive five infectious~     A. stephensi mosquito bites using standard CHMI procedures. Twenty-six weeks (six months)~     after that challenge, all of the protected subjects in Arms 1 and 2 (up to 16) and another~     six malaria-naïve infectivity controls will receive five infectious A. stephensi mosquito~     bites on the same day using standard CHMI procedures. For subjects in Study Arms 1 and 2 with~     documented parasitemia after the first CHMI or who are discontinued for other reasons after~     the first CHMI, and for the infectivity controls, additional follow up will occur on Days 90~     and 180 after their first CHMI. SAEs will be recorded from the day of CHMI through the end of~     study follow up and clinical laboratory evaluations for safety will be performed on Day 29~     and as clinically indicated (all subjects) and, for subjects with documented parasitemia, on~     the day malaria treatment is initiated and three days after malaria treatment is initiated.~     The primary objectives are to: 1) assess the safety and reactogenicity of candidate GAP3KO~     malaria vaccine when administered by the bite of approximately 200 infected mosquitoes on a~     five dose schedule, with the first four vaccinations given four weeks apart and the fifth~     vaccination given eight weeks after the fourth vaccination, and on a three dose schedule,~     with the second vaccination given four weeks after the first vaccination and the third~     vaccination given eight weeks after the second vaccination, to healthy malaria-naïve adults~     aged 18 through 50 years , 2) confirm attenuation of GAP3KO parasites by assessing the~     occurrence of breakthrough peripheral parasitemia from the time of first GAP3KO~     administration through 28 days after last GAP3KO administration.~   "
30422|NCT03168841|"~     Onychomycosis, a common pathology of the toenails, is even more prevalent among diabetic~     subjects. Nearly 26 million Americans suffer from diabetes, and approximately one-third of~     subjects with diabetes have toenail onychomycosis. Numerous studies have addressed the~     efficacy and safety of both topical and oral antifungal treatment options for onychomycosis~     in diabetic subjects. However, no study to date has specifically addressed the efficacy and~     safety of efinaconazole among diabetic subjects.~      The objective of this noncomparative, uncontrolled study is to determine the efficacy of~     topical efinaconazole 10% for toenail onychomycosis among subjects with diabetes mellitus.~     Specific indicators to measure efficacy of treatment will be the mycological cure rate,~     complete cure rate, and treatment success. Furthermore, an additional goal of the study is to~     gain knowledge of safety in the setting of a cohort of diabetic subjects~   "
30423|NCT03168828|"~     The purpose of this study is to determine if TAR-302-5018, an investigational drug-delivery~     system, is safe and tolerable in patients with neurogenic detrusor overactivity (NDO)~     resulting from spinal cord injury (SCI).~   "
30424|NCT03168815|"~     Pneumonia is a lung infection. Fiberoptic bronchoscopy is a test to diagnose the type of lung~     infection. While this procedure is being performed, a small amount of oxygen is delivered~     into the nose (low flow nasal cannula). Occasionally during this procedure, the blood oxygen~     of the patient may drop and an intervention such as increasing the oxygen flow, or placing~     the patient on a breathing machine is required. An alternative device called 'Optiflow' can~     provide high flow oxygen through nasal cannula, and is comfortable for patients. If Optiflow~     is used during bronchoscopy, it may prevent the blood oxygen from dropping.~   "
30425|NCT03168802|"~     This is a prospective, randomized, two-arm, phase II study.~      The purpose of this study is:~        -  To evaluate and compare the efficacy and safety of magnetic resonance-guided focused~          ultrasound (MRgFUS) and radiofrequency ablation (RFA) for treatment of facet-joint~          osteoarthritis low back pain.~        -  Determining the effect of the MRgFUS System and RFA for improving functional~          disabilities and in reducing pain resulting from facet-joint osteoarthritis low back~          pain. Efficacy will be determined by the level of pain relief (as measured by the~          Numerical Rating Scale, NRS), decrease in analgesics/opiate, improved quality of life~          (as measured by the Oswestry Disability Questionnaire, ODQ, and core outcome measures~          index questionnaire, COMI), pain interference with function (as measured by the Brief~          Pain Inventory-Interference scale, BPI-QoL), general health status (as measured by the~          EQ5D), physical exam, X-ray and MRI studies from baseline up to 12-Months post- MRgFUS~          and radiofrequency treatment.~        -  Evaluate incidence and severity of adverse events associated with the MRgFUS system and~          RFA used for the treatment of pain resulting from facet-joint osteoarthritis low back~          pain.~   "
30426|NCT03168789|"~     This study is 12 months long and consists of 5 visits at baseline, months 1, 3, 6, and 12. To~     determine eligibility potential subjects will have resting blood pressures (BP) measured on 2~     occasions. Pre-hypertensive individuals will be invited to participate in the study. After~     informed consent is obtained, subjects will complete baseline visit consisting of a survey,~     resting BP, wear activity watch for 7 days ambulatory blood pressure monitor for 24-hours,~     collect saliva and urine samples. Subjects will then be randomly assigned to Tension Tamer~     (TT) or lifestyle education program delivered via smartphone (SPCTL) groups. At the remaining~     4 visits subjects will again complete a survey, resting BP, wear activity watch for 7 days~     ambulatory blood pressure monitor for 24-hours, collect saliva and urine samples. Throughout~     the 12 months TT group will meditate twice daily and SPCTL group will log physical activity.~   "
30427|NCT03168776|"~     The primary objective of this trial is to compare the safety and efficacy of the SINOMED BuMA~     Supreme biodegradable coronary stent in patients with up to 3 coronary lesions to either the~     XIENCE or Promus durable polymer coronary stents.~      This prospective, global, multi-center, randomized 2:1, single blind study will enroll up to~     1632 subjects at up to 130 investigational sites in North America, Japan, and Europe.~     Subjects will have clinical follow-up in-hospital and at 30 days, 6 months, 12 months, and 2,~     3, 4, and 5 years.~   "
30428|NCT03168763|"~     The goal of this research study is to learn about the effects of a doctor's characteristics~     on participant's preference for a doctor. Researchers also want to learn about how a doctor's~     characteristics affect participant's options about professionalism and compassion.~   "
30429|NCT03168750|"~     This prospective study will evaluate the hip function and quality of life of patients~     operated for total hip arthroplasty with Masterloc femoral stem and MPACT acetabular cup. The~     results of this study will establish the performance of Masterloc femoral component (Medacta~     International SA) and MPACT acetabular component (Medacta International SA), and provide a~     general estimate of survivorship, clinical effectiveness and complications.~   "
30430|NCT03168737|"~     This goal of this clinical research study is to learn the best time to have a PET-CT scan~     after receiving (18)F-fluoroazomycin arabinoside ([18F]FAZA).~      During certain types of scans (like PET-CT scans), an imaging agent is injected into your~     bloodstream to help certain parts of your body be more clearly seen during the scan.~     [18F]FAZA is a new imaging agent designed to show how much oxygen is in a tumor during a~     PET-CT scan.~      This is an investigational study. The imaging agent [18F]FAZA is an investigational drug and~     its use in PET-CT scans is not FDA approved or commercially available. Its use in this study~     is investigational.~      The study doctor can describe how [18F]FAZA is designed to work.~      Up to 15 participants will be enrolled in the study. All will take part at MD Anderson.~   "
30431|NCT03168724|"~     Goal Management Training (GMT) is a cognitive rehabilitation program targeting executive~     dysfunction (problems with attention, reasoning, problem solving, planning, etc), which is a~     central problem in HIV-associated neurocognitive disorder. It teaches self-management~     principles, stress management and mindfulness, and trains participants in the use of several~     strategies to reduce cognitive load in everyday tasks, and methods to cue attention to~     maintain focus on specific tasks. GMT is a manualized protocol with set content conveyed~     through a combination of slides and a workbook. Two-hour small group sessions are led, in~     person, by a trained therapist once a week, for nine weeks. The small group sessions allow~     participants to learn from each other, enhancing engagement. GMT has been shown to improve~     cognitive function in a variety of neurological conditions, as well as in healthy older~     people with cognitive concerns. These improvements have been shown to last at least 6 months~     in some studies and are accompanied by changes in the brain networks underlying executive~     function. GMT is thus a well-validated, high yield intervention with which to test the~     potential of cognitive rehabilitation in older HIV+ people with cognitive concerns.~      The researchers hypothesize that GMT will lead to improved cognitive function as assessed by~     better performance on cognitive tests and reduced self-reported cognitive difficulties in~     people with stable HIV infection who report cognitive difficulties at baseline.~   "
30432|NCT03168711|"~     This is a multi-center, 20-week study of inosine treatment.~      Study Objectives and Endpoints The primary objective of the study is to determine the safety~     and tolerability of oral administration of inosine (administered daily) dosed to moderately~     elevate serum urate over 20 weeks.~      The primary outcome measures will be~        1. Safety, as measured by adverse events~        2. Tolerability, defined as the ability of subjects to complete the entire 20-week study.~      As an exploratory objective, we will test the feasibility and utility of a smartphone~     application for monitoring symptoms and disease progression in patients with amyotrophic~     lateral sclerosis (ALS).~   "
30433|NCT03168698|"~     The study investigators are comparing 2 drugs (oxytocin and carbetocin) at 2 different~     dosages, to help prevent serious bleeding (hemorrhage) after cesarean deliveries. These drugs~     are used routinely to help contract the uterus and keep it contracted after the delivery of~     the baby and placenta; this reduces the amount of blood you might lose. At Mount Sinai~     Hospital, currently oxytocin is used, but its effect on the uterus is much shorter than that~     of carbetocin. Internationally, there is no consensus as to what the most effective drug to~     use is and at which dose. The Society of Obstetricians and Gynaecologists of Canada has~     recently revised its guidelines to suggest 100 micrograms (mcg) of carbetocin as the drug of~     choice at elective cesarean section. Guidelines from the United Kingdom and the United States~     currently suggest oxytocin at various doses as the drug of choice at elective cesarean~     sections. Previous studies at Mount Sinai Hospital have shown that lower doses of oxytocin,~     0.35 International Units (IU), and carbetocin, 20 mcg, may be as effective as the higher~     recommended doses. The investigators plan to conduct a large study to confirm these findings~     so that they can use the most appropriate dose in the future. Furthermore, the investigators~     hope to demonstrate that side effects are lower with the lower dose regimens.~   "
30434|NCT03168685|"~     The purpose of this study is to evaluate the utility and user experience of a smart phone app~     for people with medical conditions, used in conjunction with an ActiGraph wearable device and~     a connected scale.~   "
30435|NCT03168672|"~     This is a Post Market Clinical Follow Up (PMCF) study to monitor the safety and performance~     of the GLOBAL ICON stemless humeral component. The data gathered will be used to support post~     market surveillance of the device, and may potentially be used for additional market access~     purposes.~   "
30436|NCT03168659|"~     This is a post-approval study to evaluate the clinical outcomes in a cohort of participants~     treated during commercial use of the HeartLight System to confirm results of the previously~     conducted pivotal clinical study.~   "
30437|NCT03168646|"~     there are many management options of ulnocarpal abutment depends on clinical evaluation and~     imaging of this joint. Arthroscopic treatment is the simplest solution for these conditions.~   "
30438|NCT03168633|"~     Diabetic patients need to manage their glucose level, physical activity and food intake to~     successfully cope with their disease. Previous work has shown that reminders of the disease,~     be they informational or about ones' condition, can improve management of disease in~     diabetes.~      This trial focuses on delivering these reminders, via email, in attempt to improve the~     patients glycemic control (measured in Hemoglobin A1C)~   "
30439|NCT03168620|"~     Aim: To evaluate whether glass ionomer interim therapeutic restoration (ITR) in asymptomatic~     teeth with deep cavities can help in determining the pulp status. Methodology: 146 mandibular~     molars with deep carious lesion having positive response to pulp sensitivity were randomly~     allocated to two study groups (75-ITR, 71- NON-ITR group). In the first group after partial~     caries removal(PCR), interim therapeutic restoration of glass ionomer cement (GIC) Ketac~     molar was placed for one month before definitive adhesive restoration. In NON-ITR group,~     cavity preparation was similar to ITR group, but definitive restoration was done in the same~     visit. Two examiners evaluated the clinical and radiographic outcomes for 18 months. Success~     was defined as absence of signs and symptoms of irreversible pulpitis and absence of~     periapical alterations.~   "
30440|NCT03168607|"~     Currently, there is no standard second line treatment for patients with neuroendocrine~     carcinoma. Irinotecan monotherapy or combination regimen has shown promising in previous~     study. The study was designed to confirm thet FOLFIRI regimen can be used as a second-line~     regimen for patients with advanced or metastatic neuroendocrine carcinoma who have progressed~     after first-line chemotherapy with platinum based regimen.~   "
30441|NCT03168594|"~     The study will be conducted to compare the safety and efficacy of irinotecan combined with~     cisplatin (IP regimen) and etoposide combined with cisplatin (EP regimen) in advanced or~     metastatic gastrointestinal pancreatic and esophageal neuroendocrine carcinoma.~      In this prospective randomized phase II study, the investigators aim to compare the survival~     benefit as well as the safety for irinotecan combined with cisplatin (IP regimen) versus~     etoposide combined with cisplatin (EP regimen) in advanced or metastatic gastrointestinal~     pancreatic and esophageal neuroendocrine carcinoma.~   "
30442|NCT03168581|"~     A multicenter, open-label phase 2a trial of CN-105 in patients with supratentorial~     intracerebral hemorrhage (ICH). Patients will be evaluated for eligibility within 12 hours of~     symptom onset. Eligible participants (approximately 60) will receive CN-105 administered~     intravenously (IV) for a 30-minute infusion every 6 hours for up to a maximum of 3 days (13~     doses) or until discharge (if earlier than 3 days). Participants will be monitored daily~     throughout the Treatment phase of the study (up to a maximum of 5 days) and will receive~     standard-of-care treatment for the duration of the study. Additional protocol assessments~     will be required during the Treatment phase. After discharge from the hospital, participants~     will enter a 3-month Follow-up phase, with a clinic visit at 30 days and a follow-up~     telephone interview with telephone-validated Modified Rankin Scale (mRS) at 90 days after~     first dose of study agent.~   "
30443|NCT03168568|"~     The objective of this study is to evaluate whether valsartan/sacubitril leads to a superior~     improvement in endothelial function and endocrine status compared to valsartan alone.~   "
30444|NCT03168555|"~     Investigate serial plasma samples of fibroblast growth factor 19 (FGF19) after oral~     stimulation with chenodeoxycholic acid in the same subjects before and after elective~     cholecystectomy~   "
30445|NCT03168529|"~     Ivabradine (IVA) has been shown to decrease the risk of hospitalizations for worsening Heart~     Failure and was associated with a trend towards improved mortality in the SHIFT1 trial.~     SHIFT1 excluded patients within 4 weeks of hospital discharge, so the efficacy and safety of~     IVA in this setting is less clear.~      In today's health care environment more and more patients that present to the Emergency~     Department (ED) for mild Acute Heart Failure (AHF) are being placed into observation unit and~     subsequently discharged, or discharged outright from the ED. This is not only a growing~     segment of patients, but also represents an important window of opportunity to intervene with~     a potentially effective therapy.~      Moreover, at this point in a patient's experience (being discharged after getting treated for~     exacerbation of Heart Failure), it's not clear that beta blockers (BB) should yet be~     increased/started due to the recent state of exacerbation.~      Standard treatment of worsened heart failure presenting to the ED or urgent care includes~     diuretics (e. g. furosemide) and vasodilators (e.g. ACE-I, ARB, Hydralazine/Isosorbide or~     ARNi), but according to usual standard of care, titration of beta blockade is often reserved~     for outpatient follow up after a period of demonstrated stability (in the ambulatory~     setting).~      This is in contradistinction to hospitalized patients, where patients have been observed by~     the treating team for days, presumably show stability and improvement, and starting low dose~     BB at the time of hospital discharge has been shown to be safe. As such these ED/Observation~     discharge patients are often not optimal candidates for intensification of BB at the time of~     release, and could be considered to be at maximally tolerated BB dose (for at least for 2-4~     weeks). This may represent a vulnerable period for these patients; its unknown in the setting~     of Observation discharge but evidence from hospitalized patients indicates that the highest~     daily risk of rehospitalization is in the days just after discharge. IVA may be effective~     post observation unit management (where lower risk Heart Failure (HF) patients are typically~     placed), to reduce heart rate (without decreasing contractility, such as a BB would) to help~     reduce the risk of hospitalization or emergency care, but safety and efficacy (in terms of~     heart rate lowering) in this setting has not been previously explored.~      Additionally, the SHIFT1 trial lacked African Americans and this unique patient population~     has not been previously studied with IVA. The investigating sites serve a predominantly~     African American patient population. Therefore the proposed study represents an important~     opportunity to gather data on IVA effect in this understudied group of patients.~   "
30446|NCT03168516|"~     Extremely low gestational age neonates (ELGANs), i.e. those born at <28 weeks, frequently~     experience intermittent hypoxemic/hyperoxemic episodes. Observational data indicate that~     severe and prolonged hypoxemic episodes are associated with retinopathy of prematurity (ROP),~     impaired long-term development and death. Closed-loop automated control of the inspiratory~     fraction of oxygen (FiO2-C) reduces time outside the oxygen target range, decreases number~     and duration of hypo- and hyperoxemic episodes, and reduces caregivers' workload. The~     proposed observer-blinded randomized controlled trial was designed and will be powered to~     compare the effect of FiO2-C in addition to manual adjustments, in comparison with manual~     adjustments of FiO2 only, on death and severe complications of prematurity thought to be~     related to hypoxia/hyperoxia and neurodevelopmental impairment in ELGANs. The results of this~     trial may help to improve the quality of life of ELGANs and reduce the burden of significant~     morbidity as well as costs for health care and society~   "
30447|NCT03168503|"~     The aging process leads to a marked decline in immune function (immunosenescence), causing a~     significant reduction in immune response after vaccination or infections. Dietary~     intervention is an attractive, safe and non-invasive way to impact on gut bacteria and~     subsequently the functioning of the immune system. The ability of the dietary supplementation~     to alter these functions can be of particular importance in those groups that have an~     underdeveloped, poorly functioning immune system such as infants, immuno-compromised subjects~     or elderly. Research over the past two decades has provided evidence that administration of~     probiotics (live microorganisms which, when administered in adequate amounts, confer a health~     benefit on the host) could enhance immune function. Lactobacilli and bifidobacteria are the~     most common probiotics used in humans and various strains have been shown to have~     immunostimulatory properties in vitro and in experimental models, these properties include~     modulation of cytokine production. evidence exists of the immunostimulating effects of~     certain probiotics and the potential to use prebiotics to increase the levels of beneficial~     bacteria (which are known to be reduced in elderly population). Furthermore, by providing a~     probiotic at the same time as a prebiotic conditions for survival are enhanced. To date, only~     a small number of studies conducted have been randomised and/or placebo controlled to~     unequivocally demonstrate efficacies.~   "
30470|NCT03168204|"~     The evaluation of a detection and prevention program which aims to create a continuum of care~     and support for frail community-dwelling older people (from early detection, over~     intervention, to follow-up). First, the program aims to develop methods to easily, accurately~     and timely detect and prevent a negative frailty-balance in older people. Second, the study~     aims to improve the quality and efficacy of care and support given to frail~     community-dwelling older people.~   "
30471|NCT03168191|"~     This study is to examine if inhaled doses of an e-cigarette flavor, alone and in combination~     with menthol, changes the appeal of e-cigarettes containing low and high doses of nicotine.~     The hypothesis is that menthol and the other experimental flavor will interact with nicotine~     dose to improve taste and liking for e-cigarettes.~   "
30448|NCT03168490|"~     In the last two decades, a series of epidemiological studies have shown a particular increase~     in Coeliac Disease (CD), a life-long intolerance to gluten proteins (the seed storage~     proteins) present in most cereals (wheat, barley and rye) both in the United States and~     Europe, and in developing countries. In these subjects, the consumption of cereals containing~     gluten causes a chronic inflammatory process leading to lesions in the small intestine and a~     dysfunction in nutrient absorption.The only current treatment for CD is a strict lifelong~     gluten-free diet. In most cases (some people do not respond) this dietary regimen guarantees~     the full recovery of small intestine architecture and functions, though for many patients the~     gluten-free diet is highly restrictive, especially for social events and during travelling.~     In addition, this dietary therapy has often low content of vitamins and ions, such as~     vitamins B and calcium, iron, zinc and magnesium, as well as fibre. Furthermore, one of the~     major risks is to develop obesity and diseases related to metabolic syndrome.~      Recently a new and innovative detoxification method has been developed with the purpose to~     overcome the disadvantages of the prior methods. The method is based on the application of~     microwave energy for few seconds to hydrated wheat kernels; the treatment induces~     modifications to endosperm components which dramatically reduce the immunogenicity of the~     most common epitopes involved in coeliac disease, without compromising the technological~     properties necessary to process flour into bread, pasta and other baked goods.~      The method is based on the analysis of recent studies that have reported, when high~     temperatures are applied to the caryopsis of wheat, the protein polymers present in the pasta~     produced with these baked grain present a size distribution pattern that is not observed in~     pasta during the drying cycles. The researchers Lamacchia and others explained this~     phenomenon on the basis of the fact that in the caryopsis of wheat, gluten is not yet formed~     and gluten proteins are deposited in different protein bodies.~   "
30449|NCT03168477|"~     The purpose of this research is to compare two different approaches for treating patients~     with shoulder impingement: electric dry needling and spinal manipulation versus~     impairment-based manual therapy, exercise electro-thermal modalities. Physical therapists~     commonly use all of these techniques to treat shoulder impingement. This study is attempting~     to find out if one treatment strategy is more effective than the other.~   "
30450|NCT03168464|"~     NSCLC patients with metastatic disease who have failed at least one prior treatment and have~     a minimum of two metastatic lesions (at least one measurable), are eligible if they have an~     ECOG Performance Status of 0-1. Patients will receive on Day 1, ipilimumab (every 6 weeks)~     concurrently with radiation (6Gy x 5 fractions). Nivolumab (every 2 weeks) will be given in~     addition to ipilimumab on day 22.~   "
30451|NCT03168451|"~     In an attempt to reduce smoking-related health disparities, investigators will implement a~     text messaging-based smoking cessation intervention in collaboration with state quit lines.~     The approach is based on the successful STOMP (STOp smoking by Mobile Phone) program, a text~     messaging-based smoking cessation intervention among young Maori adults in New Zealand.~     Investigators will adapt the STOMP intervention, which will result in a new intervention~     known as AI STOMP (American Indians STOp smoking by Mobile Phone).The primary aim of the~     study is to determine the effectiveness of the AI-STOMP intervention in smoking cessation~     among American Indians.~   "
30452|NCT03168438|"~     This study is intended for men and women at least 18 years of age who have relapsed and/or~     refractory multiple myeloma. This 2-arm randomized pilot study will test the safety,~     tolerability and efficacy of NY-ESO-1ᶜ²⁵⁹T alone (Arm 1) or in combination with pembrolizumab~     (Arm 2) in subjects who have the appropriate HLA-A2 marker, and whose bone marrow expresses~     the NY-ESO-1 and/or LAGE-1a protein.~      This study will take a subject's T cells and give them a T cell receptor protein that~     recognizes and attacks the tumors.~   "
30453|NCT03168425|"~     The number of opioid overdose deaths in the United States has quadrupled in 15 years, a~     dramatic manifestation of the current opioid abuse epidemic. This rise parallels a sharp~     increase in the amount of legal prescription opioids dispensed. The abundance of prescription~     opioids available is a primary pathway for opioid abuse and diversion. Adjusting post-~     cesarean delivery opioid prescribing practices to better match actual patient need has the~     potential to reduce unused opioids available for diversion, nonmedical use, and development~     of chronic dependence, as well as reduce wasted resources.~   "
30454|NCT03168412|"~     This phase IV clinical study was designed to evaluate the immunogenicity and safety of the~     recombinant Hepatitis E vaccine (Hecolin®), manufactured by Xiamen Innovax Biotech CO., LTD.,~     in healthy adults (over 18 years) with accelerated vaccination schedule. The study volunteers~     will receive the 3 doses of Hecolin® administered intramuscularly according to a 0-7-21 days~     schedule or a 0-1-6 month schedule.~   "
30455|NCT03168399|"~     To evaluate the acceptability, tolerance and effect on metabolic control of PKU Explore, a~     renovated Phe free protein substitute for the dietary management of PKU in children from 6~     months to 5 years.~   "
30456|NCT03168386|"~     Early stroke rehabilitation is known to be an effective and essential therapy in gaining~     functional independence and preventing complications. However, there was no consensus of~     proper amount of motor rehabilitation in stroke patients. In this study, the investigators~     investigated the effects of the intensive motor rehabilitation during subacute phase to~     improve motor function at 6 months after onset in patients with first-ever strokes.~   "
30457|NCT03168373|"~     Early stroke rehabilitation is known to be an effective and essential therapy in gaining~     functional independence and preventing complications. However, there was no consensus of~     proper amount of language rehabilitation in stroke patients. In this study, the investigators~     investigated the effects of the intensive language rehabilitation during subacute phase to~     improve language function in patients with first-ever strokes.~   "
30458|NCT03168360|"~     Early stroke rehabilitation is known to be an effective and essential therapy in gaining~     functional independence and preventing complications. However, there was no consensus of~     proper amount of cognitive rehabilitation in stroke patients. In this study, the~     investigators assess the effects of the intensive cognitive rehabilitation during subacute~     phase to improve cognitive function at 6 months after onset in patients with first-ever~     strokes.~   "
30472|NCT03168178|"~     The purpose of this study is to determine whether antibiotics can be safely avoided in women~     who develop a fever during labor. Because investigators have no accurate tests to determine~     whether women who develop fever during labor have intra-amniotic infection, antibiotics are~     often used to prevent spread of infection to the fetus.~   "
30473|NCT03168165|"~     This is a cluster randomized trial that involves training regions of physical therapy clinics~     to use pain neuroscience education or continue with usual care. The investigators will~     examine outcomes for patients with chronic neck or back pain.~   "
40166|NCT03040973|"~     The rollover study will provide continued treatment and assessment of long-term safety~     follow-up in patients receiving capmatinib (INC280) in a Novartis sponsored study and in the~     opinion of the Investigator would benefit from continued treatment.~   "
30459|NCT03168347|"~     In dermatology, biologic medications are used to treat conditions such as moderate-to-severe~     psoriasis. These medications generally function to decrease inflammation or disrupt the~     inflammatory cycle. Examples of biologic medications commonly used in dermatology include~     tumor necrosis factor-alpha (TNF-alpha), blockers/inhibitors (etanercept, infliximab,~     certolizumab pegol, golimumab), interleukin 12/23 blockers (ustekinumab) and interleukin 17A~     blockers (secukinumab, ixekizumab).~      Due to biologic medication's efficacy and safety profiles, they have revolutionized~     dermatology and the general medical field. However, patients may be apprehensive about~     choosing a biologic medication for a variety of reasons. These include hearing negative~     information about the drug from friends or family, being nervous about injection, or seeing~     the drug or its side effects negatively portrayed in the media. Many patients are not aware~     that clinical trial evidence for biologics exist, and instead may rely on anecdotal evidence~     in choosing to take these medications.~      Because fear of the drug is inherently subjective, it can be modified with appropriate~     reassurance and presentation of evidence. Physicians must be able to ascertain from where the~     fear originates and how it can be countered. By understanding what kind of information will~     allow patients to be confident in their decision to take a biologic, dermatologists can~     improve outcomes and initiate use of this drug. Furthermore, reducing fear of side effects or~     adverse events may improve adherence to treatment and may improve treatment outcomes. The~     investigators propose this study with the goal of learning whether patients are more~     confident in the potential success of biologic medications in treating their psoriasis after~     being presented with clinical trial evidence, anecdotal evidence, or both.~   "
30460|NCT03168334|"~     This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed~     to assess the safety, efficacy, and tolerability of IDP-123 Lotion and IDP-123Vehicle Lotion.~   "
30461|NCT03168321|"~     This is a multicenter, randomized, double-blind, vehicle-controlled study designed to assess~     the safety, efficacy, and tolerability of IDP-123 Lotion in comparison with IDP-123 Vehicle~     Lotion.~   "
30462|NCT03168308|"~     This prospective, randomized, double blinded study is intended to enroll a total of 92~     patients undergoing thoracic surgery with general endotracheal anesthesia at Parkland~     Hospital. Patients will be randomized to receive either neostigmine or sugammadex for~     reversal of neuromuscular blockade. Merck, Inc. will supply the sugammadex through an~     agreement with Parkland Investigational Drug Services. Neostigmine is readily available for~     anesthesiologists to use and is the current standard of care for reversal of neuromuscular~     blockade. A standardized anesthetic protocol that is usual and customary for the type of~     operation the patient is having will be provided to the anesthesia teams of enrolled~     subjects. The remainder of the anesthetic care of the subject will not deviate from the~     standard of care. The surgeon, anesthesia team, PACU nurse, and research assistant will be~     blinded as to which reversal drug the patient receives. The only individual that will know to~     which drug the patient has been randomized will be the pharmacist who draws up the~     medication(s). A blinded research assistant will record postoperative outcomes and the~     patient will be followed until postoperative day (POD) 3.~   "
30463|NCT03168295|"~     Purpose/Objectives: Examining the effect of SGLT2 inhibition on EGP and plasma glucose~     concentration in diabetic subjects after kidney transplantation (i.e. renal denervation) or~     in subjects after renal sympathectomy (63) can add insight about the possible role of a~     neural arc which mediates the changes in plasma glucagon and/or insulin concentration in~     response to glucosuria.~   "
30464|NCT03168282|"~     The purpose of this study is to determine the feasibility of identifying novel etiologic~     agents associated with SARI in patients who have required intubation and in whom, after~     analysis, a causative agent was not identified by standard microbiologic (culture) and~     multiplex real-time Polymerase Chain Reaction (PCR) platforms. Taking into account that~     isolation of any pathogens is generally time sensitive, the study will evaluate subjects that~     are culture negative at the time of consent. Not all subjects will actually prove to be~     culture negative. Additionally, the study will compare etiologic agents identified on~     broncho-alveolar lavage (BAL) to etiologic agents identified by routine upper airway testing~     on all subjects with SARI.~   "
30465|NCT03168269|"~     Coronary Computed Tomographic Angiography (CCTA) is emerging as the diagnostic test of choice~     in chest pain patients with low to intermediate probability of coronary artery disease (CAD).~     Qualified CCTA readers may not be available around the clock in most centers, limiting the~     use of CCTA. This study aimed to determine if well-qualified CCTA technicians can provide~     initial accurate diagnosis to guide initial management and triage of such patients~   "
30466|NCT03168256|"~     This trial will test the hypothesis that the administration of CF101, a novel~     anti-inflammatory agent, to patients with moderate to severe plaque psoriasis will relieve~     signs and symptoms of the disease. CF101 effect will be in comparison to apremilast in this~     study population~   "
30467|NCT03168243|"~     Enteral tube feeds are commonly used to meet the entire or partial nutritional requirements~     of patients with disease-related malnutrition and other conditions who need nutrition~     support. A large proportion of tube fed patients have increased protein and/or energy~     requirements due to a higher body mass or increased metabolic stress as a result of disease,~     surgery or trauma. A high energy, high protein feed has been developed to help meet the needs~     of such patients. The aim of this study is to investigate the tolerance, compliance and~     acceptability of this high energy high protein tube feed in adult patients who require~     nutritional support via tube feeding. 50 eligible patients requiring tube feeding will~     receive the high energy, high protein feed, according to nutritional requirements for 4~     weeks. The primary outcome is nutritional intake, and secondary outcomes include~     gastrointestinal (GI) tolerance, compliance, acceptability and functional measures.~     Additional exploratory outcomes of quality of life and micronutrient levels will also be~     investigated.~   "
30468|NCT03168230|"~     For patients with colorectal liver metastasis (CLM), the prospect of long-term survival~     relies on liver resection. Wistfully, more than 75 % of patients with CLM are initially~     unresectable, due to an insufficient future liver remnant (FLR) volume~      In order to increase FLR volume, most patients will first receive chemotherapy to reduce the~     tumor load (downsizing).~      When chemotherapy is insufficient to provide an adequate postoperative FLR, portal vein~     embolization (PVE) can be performed. About 50-70 % of patients undergoing PVE obtain a~     sufficient liver hypertrophy to allow liver resection.~      While PVE is recognised for its efficacy to induce liver hypertrophy, some studies expressed~     substantial concerns regarding the potential adverse effect of this intervention on~     pre-resection tumor progression, increased risk of cancer recurrence following resection and~     reduced overall survival following resection~      Those studies suggested that the need to perform PVE should be assessed thoroughly for each~     patient and that chemotherapy should be maintained during the whole hypertrophy process in~     order to contain the potential adverse effect of PVE on tumor progression.~      Other studies found no significant association between PVE and negative oncological outcomes.~      As mentioned in almost every study cited above, more data is needed to provide a clearer~     vision regarding the impact of PVE on tumor progression and cancer recurrence following liver~     resection.~      The aim of this study is to compare the overall and disease-free survival of PVE-requiring~     patients to the ones who underwent upfront surgery (NoPVE).~      As a secondary objective, the impact of several covariates (related to surgery, patient's~     condition and disease stage) on survival and cancer recurrence will be tested.~      Our hypothesis are that 1) PVE might be associated with a lower overall survival and a higher~     risk of cancer recurrence in univariate analysis but 2) this association will not remain~     significant when other covariates are included in the proportional COX hazard models.~   "
30474|NCT03168152|"~     This is a randomized phase II study comparing microwave ablation (MWA) and stereotactic body~     radiation therapy (SBRT) for localized hepatocellular carcinoma (HCC).~      This trial will be the first prospective comparison of these modalities for the treatment of~     HCC and will provide critical information regarding which local ablative modality is most~     appropriate for which patients. This study will also provide important information regarding~     quality of life and liver function changes following these two different treatment~     modalities.~   "
30475|NCT03168139|"~     The purpose of this study is to show that the type, number and/or distribution of tumor~     metastases infiltrating immune cells such as cytotoxic T cells and/or the cytokine signature~     in the tumor metastases can be modulated by treatment with olaptesed pegol and to explore~     safety, tolerability and efficacy of olaptesed pegol in combination with pembrolizumab as a~     basis for subsequent studies in combination with immunotherapies, in particular checkpoint~     inhibitors.~   "
30476|NCT03168126|"~     Background: Anesthesia in free flap surgery is challenging. Monitoring of hemodynamic changes~     and their influence on the cardiovascular system in permanent feedback loops allow control,~     which is what anesthesiologists aim for to ensure an adequate blood flow and tissue~     oxygenation. The circulatory support and inferable volume administration are managed via~     heart rate (HR) and mean arterial pressure (MAP), but both parameters are influenced by~     variable components and are thus unfavorable for volume management. The aim of this study was~     to evaluate whether volume requirement may be assumable to additional monitoring parameters.~      Methods: 31 patients were enrolled prospectively. HR, MAP, central venous pressure and O2~     saturation were comprehended based on the protocols. We expanded the data set by a permanent~     blinded intraoperative monitoring with registration of the Cardiac Index (CI) and Stroke~     Volume Variation (SVV) and semi-invasive pulse-contour analysis utilizing the Pro-AQT-Device.~   "
30477|NCT03168113|"~     This is a prospective, single center, clinical mechanistic pilot clinical research study.~     Participants will not receive any investigational agent. The investigators will examine~     whether children with atopic dermatitis (AD) and food allergy have a different skin barrier,~     microbiome, epidermal transcriptome, and epidermal lipid composition than children with AD~     and no food allergy and non-atopic (NA) children. Participation involves a single study~     visit.~   "
30478|NCT03168100|"~     The Total Therapy treatment regimens developed at the Myeloma Institute have demonstrated~     great improvement in treatment outcomes for multiple myeloma patients. However, some patients~     still relapse early during maintenance treatment meaning that better options are still~     needed. This study will evaluate a treatment regimen that alternates two different 3-drug~     regimens every eight weeks for patients that have previously completed autologous stem cell~     transplant. The two regimens are bortezomib, lenalidomide, and dexamethasone (VRD) which will~     be alternated with Elotuzumab, lenalidomide, and dexamethasone (Elo RD). Effectiveness will~     be measured by the depth of response (i.e., whether or not minimal residual disease (MRD)~     negative status is achieved). The rate of MRD negativity from this study will be compared to~     historical control data from the Total Therapy 4 trial which used continuous VRD maintenance~     therapy after stem cell transplant(s).~   "
30479|NCT03168087|"~     Fluids administered intravenously may alter whole blood coagulation. However, little is known~     about the dose-response relationships of hemodilution in plasmalyte-148 solution.~     Investigators have therefore performed the present study to measure the effect of a~     plasmalyte-148 solution on the coagulation pathway according to the hemodilution level using~     a rotational thromboelastometry (ROTEM®) tests.~   "
30480|NCT03168074|"~     The Investigators hypothesize that single agent lenvatinib has biological activity in~     estrogen receptor positive breast cancer, and that the effects are more pronounced in~     patients with positive RET expression in the tumor.~   "
30481|NCT03168061|"~     The goal of this study is to find the highest tolerated dose of NC-6300 that can be given to~     patients with advanced solid tumors or soft tissue sarcoma. The safety and tolerability of~     the drug will also be studied.~   "
30482|NCT03168048|"~     The present single-center prospective exploratory study, conducted at Heidelberg University~     Hospital, assesses the feasibility of introducing a concept for additional patient care based~     on a mobile application for patients undergoing radiotherapy. Patients presenting themselves~     for the irradiation of thoracic or pelvic tumors will be surveyed regarding general~     performance, treatment-related Quality of Life (QoL) and symptoms and their need to~     personally consult a physician on a treatment-daily basis by means of a mobile application.~     The primary endpoint of feasibility will be reached when 80% of the patients have~     successfully answered 80% of their respective questions scheduled for each treatment day.~     Furthermore, treatment-related patient satisfaction and diagnosis-related QoL is assessed by~     PSQ-18 and EORTC questionnaires at the end of radiotherapy and at the first follow-up.~   "
30483|NCT03168035|"~     The goal of this clinical research study is to find the highest tolerated dose of NC-4016~     that can be given to patients with advanced solid tumors or lymphoma. The safety of the drug~     will also be studied.~   "
30484|NCT03168022|"~     This study is an open-label, 2-way crossover, single-dose study that is being performed to~     establish the bioequivalence of TNX-102 SL 2.8 mg tablets from two manufacturers:~     manufacturer of the Phase 2/3 drug product and manufacturer of the Phase 3 and commercial~     drug product. This bioequivalence study will confirm (1) the drug product manufactured from~     these two manufacturers are therapeutically equivalent and (2) the efficacy and safety data~     obtained in clinical studies using TNX-102 SL from these two manufacturers are comparable.~   "
30485|NCT03168009|"~     The mechanisms of bariatric surgery-induced weight loss go beyond reductions in calorie~     intake and may involve several other pathways. Recently, brown adipose tissue (BAT) has been~     added as another potential player. Activation of BAT results in enhanced energy expenditure~     and promotes weight loss. Here, the investigators will study the effects of bariatric surgery~     on BAT function by PET/CT studies and molecular analyses of adipose biopsies. The~     investigators will explore different pathways that may affect BAT activation in this patient~     population.~   "
30486|NCT03167996|"~     This platform will enable investigation the cardiovascular risk reduction and the increase in~     participant engagement in their heart-healthy goals, through the use of a digital platform~     that connects them to their own doctors, nurses, and dietitians.~   "
30501|NCT03167801|"~     To evaluate the relationship between secretion of melatonin and sleep quality in spinal cord~     injury patients versus a database of healthy volunteers.~   "
30487|NCT03167983|"~     From this study, it is hoped to learn if and how the gut microbiome composition, gut~     permeability and inflammation in patients with dementia are associated with each other.~     Dysbiosis may lead to an increased gut permeability, bacterial translocation and inflammation~     which may influence pathogenesis and progression of dementia.~      The novel aspect of the study will be to understand the association between gut microbiome~     composition, gut permeability and the presence of dementia. This will help to better~     understand the pathogenesis of dementia and lead to the development of novel therapeutic~     strategies. If this hypothesis holds true, the study will be the basis to develop new~     treatment options for dementia.~   "
30488|NCT03167970|"~     This study is to examine the benefits of newly designed capsule with enhanced frame rate and~     wide angle compared to standard endoscopy, which may help enhance detecting esophageal~     diseases that otherwise may have been out of vision in the standard endoscopy, ultimately~     decreasing healthcare costs.~   "
30489|NCT03167957|"~     This is a single-center, open-label, pilot study to evaluate the efficacy of 14 days of CAMB~     dosing in subjects with fluconazole-resistant vulvovaginal candidiasis (VVC).~   "
30490|NCT03167944|"~     Breast cancer is one of the most common cancer among women nowadays. There are lots of~     modality of treatment and one of them is Mastectomy. We found out that seroma is one of the~     disturbing postoperative complications after mastectomy. In our study we want to compare the~     outcome between using the conventional electrocautery and the low thermal tissue dissection.~     We expected that the serum production should be lower in cases using low thermal system~     electrosurgery system.~   "
30491|NCT03167931|"~     The main objective of this study is to estimate the effect of the neuromodulation on the~     behavioral performances during the access in semantics according to the age of the~     individuals.~      Neuromodulation by non-invasive stimulation allows to explore the functioning of the brain by~     exciting or by inhibiting localized cortical zones. The modulation of the performances in~     cognitive tasks, further to the neuromodulation of these zones, allows to deduce on their~     functional roles.~   "
30492|NCT03167918|"~     To investigate the protective effect of calcium dobesilate, Xuefuzhuyu Decoction, calcium~     dobesilate combined with Xuefuzhuyu Decoction on the early lung function of type 2 diabetes~     mellitus~   "
30493|NCT03167905|"~     Postnatal depression affects about 10-15% of women after childbirth. Approximately 3-5% of~     women experience a moderate-to-severe depression that requires medical attention. This study~     aims to investigate the implication of pain relief choice in reducing the postnatal~     depression of women who deliver their babies.~   "
30494|NCT03167892|"~     Stroke is a common disease in older people, and often leads to various degrees of disability.~     Dysphagia is one such consequence which is associated with aspiration pneumonia and~     malnutrition. There are studies showing that oral screen-training may reduce dysphagia, but~     the method is insufficiently evaluated. Since treatment with an oral screen is easy,~     relatively quick and cheap, it is of high relevance to perform a strict and unbiased study to~     assess the feasibility and efficacy of the intervention. Thus, the aim of the present study~     is to evaluate the effect of daily oral screen training in post-stroke patients with~     dysphagia.~      A randomized controlled clinical study will be performed in subjects who have had a first~     stroke 8-12 months earlier and suffer from dysphagia. The intervention consists of daily oral~     screen training for 3 months. In total 70 subjects will be randomized to intervention or~     control. The changes in swallowing capacity is the main outcome, and secondary outcomes are~     subjective swallowing problems, lip force, chewing function and quality of life.~      Improved oral motor function and decreased dysphagia in post-stroke patients will result in~     an improved quality of life for the individual, and also reduce hospitalization and health~     care costs.~   "
30495|NCT03167879|"~     This 3-arm cluster randomized controlled trial (RCT) will compare (1) a comprehensive family~     planning (FP) program that incorporates a structured, multi-component safer conception~     counseling (SCC) intervention (SCC1) versus (2) a SCC training workshop for FP nurses (SCC2;~     less intensive and mimics approach used by Ugandan Ministry of Health (MoH) to integrate new~     services), and (3) existing FP services (usual care) at 9 HIV clinics (3 per arm) operated by~     The AIDS Support Organization (TASO) Uganda.~   "
30496|NCT03167866|"~     The investigators will examine the influence of increasing motivation on healthy lifestyle~     and glycemic control in diabetes patients. Participants will be randomized to two groups, the~     control group gets informational text message and the intervention group gets motivational~     SMS. The patients get a weekly text message and after 26 weeks the HbA1c and quality of life~     will be assessed.~   "
30497|NCT03167853|"~     This is a single-center, open-label, phase Ib study evaluating safety and efficacy of the~     humanized anti-PD-1 antibody JS001, as a monotherapy in patients with neuroendocrine tumors~     who have failed in previous systemic treatment. 40 patients are enrolled and injected with~     the humanized anti-PD-1 antibody 3mg/mg every 2 weeks until disease progresses or~     unacceptable toxicity.~   "
30498|NCT03167840|"~     This randomised controlled trial aims to determine the effectiveness of combined physical and~     cognitive training in preventing falls and decreasing risks of falls among community-dwelling~     older persons with mild cognitive impairment (MCI).~   "
30499|NCT03167827|"~     This study evaluates the effect of Physical Training and Supplementation of Isoflavone About~     Pelvic Floor Musculature in Women in the Postmenopausal period, and it has two groups the~     intervetion.~   "
30500|NCT03167814|"~     Chyle is lymphatic fluid present in the wall of the intestine. It flows trough lymphatic~     vessels to cisterna chyli and to venous circulation carrying lymphatic fluid, long-chain~     triglyceride fatty acids and proteins, fatty soluble vitamins and electrolytes. Lymphatic~     vessels are at risk of damage in pancreatic surgery and especially when there is vein/artery~     resection and reconstruction at the same time. Chyle leak can be seen in post-operative~     patients when there is milky substance coming out of the surgical drains and drain fluids~     triglyceride level is high (>1,5 mmol/l). Patients with chyle leak are at risk of~     dehydration, malnutrition, sepsis and prolonged stay at the hospital. Usually treatment of~     chyle leak is with drains and no-fat diet up to 14 days after surgery. Sometimes combined~     with somatostatine-analogue-treatment. In this study investigators are randomizing patients~     with major pancreatic surgery in to two groups. Intervention group will start no-fat diet,~     including MCT-oil, right after surgery up to 2 weeks. And control group will start the diet~     if chyle-leak is seen. End goal is to reduce chyle-leaks in post-operative patients and~     analyze if it has an effect on patients prognosis.~   "
30504|NCT03167762|"~     Photodynamic therapy (PDT) is used to treat some types of sun-damaged skin and low-grade~     forms of growths. A cream is applied to the skin, and the chemical in this cream is absorbed~     in to the skin and converted in to a 'photosensitiser'. This photosensitiser is fluorescent,~     meaning that it produces red light when blue light is shone on it. By measuring how much~     light is given off with a camera, the investigators can determine how much photosensitiser is~     present in the skin. Also, it is thought that more of the chemical is converted to the active~     photosensitiser if the skin is warmer, so the investigators plan to measure the temperature~     of the skin using a thermal camera. Light is shone on to the skin and this activates the~     photosensitiser, treating the problem area and leaving healthy skin intact. This research~     will increase the investigators understanding of how PDT works, and may help the~     investigators to improve treatment regimens so that they can be made more effective and~     better tolerated~   "
30505|NCT03167749|"~     Normal testicular hormonal and spermatogenic function depends not only on the testis itself,~     but also on the integrity of the hypothalamus and anterior pituitary. Systemic diseases has~     been shown to influence male gonadal function in variety of ways, leading to reduced libido,~     erectile impotence, infertility, osteoporosis, and decreased physical stamina and muscle~     mass. The effect of systemic diseases may occur directly at the testicular level: reduced~     Leydig cell function will lead to androgen deficiency, while diseases affecting~     Spermatogenesis may lead to infertility. Alternatively, acute and chronic illness may~     interfere with the hypothalamic-pituitary axis and lead to reduced testicular function.~   "
30506|NCT03167736|"~     The purpose of this research is to compare two different approaches for treating patients~     with lumbar spinal stenosis: electric dry needling and thrust manipulation versus~     impairment-based manual therapy, stretching, strengthening and electrothermal modalities.~     Physical therapists commonly use all of these techniques to treat lumbar spinal stenosis.~     This study is attempting to find out if one treatment strategy is more effective than the~     other.~   "
30507|NCT03167723|"~     Traumatic hemothorax and hemopneumothorax are common diagnoses which are typically treated by~     placement of a chest tube. 28-32 Fr chest tubes have previously been shown equivalent to~     36-40 Fr chest tubes for the non-emergent drainage of hemothorax. A smaller study has found~     14 Fr pigtails had less pain than larger tubes but was not powered to compare outcomes. We~     seek to perform a prospective randomized trial that is adequately powered comparing efficacy~     of 14 Fr thal tubes to 28 Fr chest tubes for non-emergent drainage of hemothorax and~     hemopneumothorax. Additionally, we will employ maximal barrier precautions for all chest tube~     insertions and compare empyema rates to our historical controls.~   "
30508|NCT03167710|"~     The purpose of this research is to compare two different approaches for treating patients~     with lateral epicondylalgia: electric dry needling, thrust manipulation and stretching versus~     impairment-based manual therapy, exercise and ultrasound. Physical therapists commonly use~     all of these techniques to treat lateral epicondyalgia. This study is attempting to find out~     if one treatment strategy is more effective than the other.~   "
30509|NCT03167697|"~     This study centres around a new one-a-day phenylalanine-free protein substitute for~     phenylketonuria patients. Fifty eligible adults (≥ 16 years) with proven phenylketonuria or~     hyperphenylalaninemia will be recruited and randomly allocated to one of two intervention~     arms (n = 25 per arm). Following a 3-day baseline period, and in addition to routine~     nutritional management, patients will receive either one sachet of the new protein substitute~     daily (intervention) or continue their usual dietary and/or protein substitute regimen~     (maximum of 1 protein substitute per day (equal to 20g protein equivalent) control) for 28~     days.~   "
30510|NCT03167684|"~     This study will evaluate the impact on blood glucose of the use of an oral appliance to treat~     obstructive sleep apnea (OSA) in individuals with Type 2 diabetes. An oral appliance is~     similar to a sports mouth guard or an orthodontic retainer and is an alternative treatment to~     continuous positive airway pressure (CPAP) for OSA. Oral appliance therapy has not been~     evaluated in patients with Type 2 diabetes with respect to glycemic outcomes. This will be a~     1:1 randomized controlled trial: The experimental group will receive the oral appliance and~     the control group will receive a sham device over the course of approximately 5 months.~   "
30511|NCT03167671|"~     AposTherapy is a home based exercise program utilizing footwear that causes exercise with~     normal activity that may significantly improve function in patients with back pain since~     patients with back pain have altered mechanics of motion contributing or due to the presence~     of the conditions. Capitalizing on the reported excellent adherence and clinical benefit of~     ApostTherapy in patients with significant knee and back pain, we propose to evaluate this as~     a conservative treatment that may supplant/supplement traditional pain medications and~     physical therapy in an at-risk urban inner city population.~   "
30512|NCT03167658|"~     There is great public and private interest in the use of workplace wellness programs to~     reduce health care spending, improve health outcomes, and enhance productivity for employees.~     However, there is little rigorous evidence on the effects of wellness programs. This study~     partners with a large multi-state U.S. employer (BJ's Wholesale Club) and an experienced~     wellness vendor (Wellness Workdays) to evaluate a multi-prong workplace wellness program,~     including components such as nutrition counseling, fitness challenges, and stress management~     workshops. The wellness program will be delivered by a team of experts and aided by~     innovative technologies, and will include financial rewards for participation. The program~     will be available to employees in 25 of BJ's 200 worksites. These sites have been randomly~     selected, allowing a randomized controlled evaluation of the effects of the wellness program.~     Data will be collected on a wide array of outcomes from multiple sources, including on-site~     biometric screenings and surveys, employment records, and health insurance claims for~     employees at both treatment and control sites.~   "
30513|NCT03167645|"~     Aim of this study is to reduce postoperative complications (assessed by POMS-Score and graded~     by Clavien-Dindo-Score) by substitution of perioperative hypoalbuminaemia in high-risk~     patients or patients undergoing high risk surgery.~   "
30691|NCT03165318|"~     This is a pilot study that evaluates the effect of PEMF in maintaining muscle mass~     postoperatively in individuals experiencing clinical immobilisation due ACL reconstruction~     surgery. Half of the participants will receive the PEMF therapy in combination with standard~     rehabilitation programme, while the other half will receive sham therapy in combination with~     standard rehabilitation programme.~   "
30514|NCT03167632|"~     Oral Ulcers have serious effect on patients' lives. Due to absence of any information about~     its prevalence, risk factors and effect on patients' lives, this study has been held. The~     investigators recruited patients from the outpatient dental clinic of the faculty of oral and~     dental medicine, Cairo University, screened them clinically for oral ulcers. All patients~     filled questionnaires about the risk factors of oral ulcers. Furthermore, oral ulcer patients~     filled questionnaires about their Quality of life, previous treatments used, previous~     physicians visited and their Quality of life after using previous treatments.~   "
30515|NCT03167619|"~     This is a randomized, international, multicenter, Phase II study designed to explore the~     efficacy of olaparib or olaparib in combination with durvalumab in platinum-treated mTNBC.~     The primary objectives are to explore olaparib or olaparib in combination with durvalumab as~     maintenance therapy following clinical benefit with platinum-based therapy in subjects with~     mTNBC.~   "
30516|NCT03167606|"~     The proposed MyPEEPS Mobile intervention is a novel and evidence-driven intervention using~     mobile technology to deliver HIV prevention information specifically developed for at-risk~     young men who have sex with men (YMSM). This will be the one of the first studies to test the~     efficacy of a scaled-up, mobile version of an existing human immunodeficiency virus (HIV)~     prevention intervention originally developed for, designed by, and piloted for, a diverse~     group of YMSM.~      MyPEEPS Mobile will be tested in an randomized controlled trial with racially and ethnically~     diverse HIV-negative or unknown status YMSM aged 13-18 at four geographically diverse sites:~     Birmingham, Chicago, New York City, and Seattle, allowing for increased generalizability of~     findings.~   "
30517|NCT03167593|"~     The objective of the present study is to evaluate the capability of the probiotic strain~     Lactobacillus coryniformis K8 CECT5711 (Lc K8) to enhance the immune response to influenza~     vaccine in elderly and the effect on respiratory symptoms related to respiratory infections.~      A randomized, double-blind, placebo-controlled trial was conducted between November of 2015~     and April of 2016. A total of 98 residents of nursing homes aged more than 65 years were~     randomly assigned to receive Lc K8 or placebo for two weeks previous to influenza~     vaccination.~      Primary outcome was the percentage of seroconversion. Secondary outcome were the incidence of~     influenza-like illness and respiratory symptoms associated to respiratory infections during~     the follow-up period of 5 months. Serum cytokines and immunoglobulins levels were also~     evaluated.~   "
30518|NCT03167580|"~     The 'REstricted versus Liberal positive end-expiratory pressure in patients without Acute~     respiratory distress syndrome' (RELAx) trial is a national multicenter, open randomized~     controlled trial in ICU patients without ARDS at start of ventilation. It will be the first~     RCT comparing ventilation with the lowest possible positive end-expiratory pressure (PEEP)~     level with ventilation with the median PEEP level currently practiced in the Netherlands that~     recruits a sufficient number of patients to test the hypothesis that ventilation with the~     lowest possible PEEP level is non-inferior to ventilation with a PEEP level of 8 cm H2O with~     regard to objective and patient-relevant clinical endpoints.~   "
30519|NCT03167567|"~     Women during their first labor will be offered the assistance of a medical clown. Their~     experience will be compared after delivery with that of primiparae who were not helped by a~     medical clown.~   "
30520|NCT03167554|"~     Achilles tendon is a frequent lower-limb tissue where tendinopathy may arise. Percutaneous~     Therapeutic Electrolysis (EPTE®) is an electronic device that enables to treat accurately,~     guided by an ultrasound, the tendon injured area by applying a galvanic current through an~     acupuncture needle. Thus, the first stage of physiological regenerative process may be~     obtained. Design: Randomized Controlled Clinical Trial. Objectives: To know the effectiveness~     of Percutaneous Therapeutic Electrolysis (EPTE®) versus a sham intervention at improving pain~     and function in patients who undergo Achilles Chronic Tendinopathy and to determine the~     efficiency of Percutaneous Therapeutic Electrolysis (EPTE®) with monopolar needle versus~     Percutaneous Therapeutic Electrolysis (EPTE®) with bipolar needle at improving pain and~     function in patients who undergo Achilles Chronic Tendinopathy. Participants: patients~     diagnosed with Achilles Chronic Tendinopathy. Setting. Infanta Leonor Hospital, Madrid,~     Spain. Experimental intervention: Percutaneous Therapeutic Electrolysis (EPTE®) with~     monopolar needle, 330 microamps, 1 min 20 sec versus bipolar needle. Sham intervention: the~     guide tube of the needle contacted with the skin and the device remained switched on to~     simulate its functioning.~   "
30521|NCT03167541|"~     This study is being conducted to investigate the rate and extent of naproxen absorption from~     the Test naproxen sodium formulation is bioequivalent to Aleve® naproxen sodium, a Reference~     product currently marketed in The Netherlands in order to support the registration of the~     Reckitt Benckiser (RB) naproxen sodium (220 mg tablets).~   "
30522|NCT03167528|"~     The aim of the study is to evaluate, 3 months after lung transplantation, integration and~     appropriation by the patient of complementary techniques ( Toolbox  included relaxation,~     autohypnosis, relaxation therapy, TENS (if pain) and holistic gymnastics to improve the~     comfort and the quality of life in very high-technology care pathway~   "
30523|NCT03167515|"~     The primary objective of this study is to determine the efficacy and safety of 074-6751~     Lotion applied twice daily for four weeks (28 days) in clinical subjects with moderate plaque~     psoriasis.~   "
30524|NCT03167502|"~     Few data exist to date on the effect of eccentric muscle building in knee osteoarthritis. No~     studies have compared the effect of eccentric versus concentric reinforcement in knee~     osteoarthritis. Our study aims to show the effectiveness of an eccentric reinforcement. This~     is a randomized, interventional trial.~   "
30525|NCT03167489|"~     This pilot study aims to demonstrate that emotional regulation (ER) is a valuable supplement~     to a documented and effective group-based lifestyle intervention on cardiovascular disease~     risk reduction maintenance in a non-clinical population by assessing changes in this primary~     outcome: Mediterranean diet adherence and these secondary outcomes: average daily steps, METS~     per week, BMI, blood pressure, physical activity, LDL, HDL, Triglycerides, Hemoglobin A1c,~     Western Diet Score, ER skills, Healthy Heart Score and eating behavior. This study will~     include 14 female hospital employees and the group intervention will be based on the gold~     standard Diabetes Prevention Study, integrating the Mediterranean Diet as well as emotional~     regulation skills based on dialectical behavior therapy. The core intervention will last 3~     months with 2 booster sessions will be conducted over 2 months.~   "
30526|NCT03167476|"~     The objectives are to:~        1. validate a panel of tissue-specific miRNAs that are differentially expressed in the~          tissue of patients with and without reactive hyperplasia and lymphoma.~        2. investigate the physiological range of the miRNA panel in lymphoma and reactive~          hyperplasia subjects.~        3. investigate the dysregulation of miRNA panel and their prognostic and predictive values~          in clinical outcomes to identifying patients with malignant lymphoma or reactive~          hyperplasia.~      The objectives are to:~        1. validate a panel of tissue-specific miRNAs that are differentially expressed in the~          tissue of patients with and without reactive hyperplasia and lymphoma.~        2. investigate the physiological range of the miRNA panel in lymphoma and reactive~          hyperplasia subjects.~        3. investigate the dysregulation of miRNA panel and their prognostic and predictive values~          in clinical outcomes to identifying patients with malignant lymphoma or reactive~          hyperplasia.~      This trial involves tissue samples diagnosed as lymphoma and reactive hyperplasia. The~     investigators will develop panels of miRNAs that are specific biomarkers of lymphoma, and~     assist clinical outcomes with these miRNAs.~   "
30527|NCT03167463|"~     Congenital choanal atresia is an abnormality of the posterior nasal passages resulting in~     complete or partial obstruction of the nasal airways. It has an incidence of 1: 5000 to 8000~     live births, with a female predominance. 41% - 72% occur in conjunction with non-syndromic~     facial abnormalities such as arched palate, cleft lip, and auricular deformities. About 4%~     present as a component of chromosomally-based syndromes such as (coloboma, heart defect,~     atresia choanae, retarded growth, genital abnormality, and ear abnormality and Treacher~     Collins syndromes.~      Previous reports have described the ratio of bony to membranous choanal atresia as 9:1.~     However, a detailed review of computed tomography study combined with histopathological~     studies has shown mixed bony-membranous atresia in about 70% of cases and purely bony atresia~     in 30% of cases.~   "
30528|NCT03167450|"~     Background:~      Sickle cell disease (SCD) is caused by a genetic defect that affects how hemoglobin is made.~     Due to this, people with SCD have abnormally-shaped red blood cells, which can result in poor~     oxygen transport in the body and increase risk of blood clots. CRISPR Cas9 is a new tool~     which allows scientists to snip and edit genes in a way that is faster, cheaper, and more~     precise than other gene-editing tools. Recently, research has been done using CRISPR Cas9 to~     correct the sickle cell gene in animal models and human cells. Researchers want to understand~     the views of those with SCD, parents of people with SCD, and the providers of these patients~     regarding use of CRISPR Cas9 in clinical trials and treatment.~      Objectives:~      To study the attitudes, beliefs, and opinions of those with SCD, parents of those with SCD,~     and providers on the use of CRISPR Cas9 gene-editing. An additional purpose of this study is~     to assess the utility of an educational tool for improving understanding of CRISPR Cas9.~      Eligibility:~      People ages 18 and older who speak English and either have SCD, are a parent of someone with~     SCD, or are a physician for people with SCD.~      Design:~      Participants will be screened via phone. Those with SCD will be screened with data from their~     SCD genotype.~      Participation lasts about 2 hours.~      Participants will fill out three surveys.~      Participants will watch a video about CRISPR Cas9.~      Participants will engage in a focus group session. This will be audiotaped and analyzed.~      The data from the survey questions and focus groups may be used for future research. However,~     all personally identifiable information will be removed before data is shared.~      Participants data will be identified with a code number instead of their name.~      Participants may be invited to join future studies of SCD.~   "
30529|NCT03167437|"~     Background:~      Crohn's disease (CD) is an inflammatory bowel disease. It causes inflammation of the gut.~     Symptoms may include diarrhea, abdominal pain, fatigue, weight loss and malnutrition. CD has~     no cure, but symptoms can sometimes be controlled with medicine. Researchers want to see if~     it is safe to treat CD with the medicine vorinostat. It is thought that vorinostat may reduce~     the inflammation process of CD. This may then help to relieve symptoms of CD.~      Objectives:~      To see if vorinostat is safe for people with moderate-to-severe CD.~      Eligibility:~      Adults 18 65 with moderate-to-severe CD that medicine is not controlling.~      Design:~      Phase I is screening. It may last 120 days. Participants will have:~      Physical exam~      Medical history~      Tests of blood, urine, and stool samples~      Heart test~      Questionnaires~      Tuberculosis skin test~      They may have a colonoscopy and lymphapheresis collection. These will be explained in a~     separate consent.~      They will keep a diary of symptoms.~      Phase II is treatment. It will take 12 13 weeks. Participants will take the study drug by~     mouth twice daily for 12 weeks. They will get a weekly phone call to talk about how the drug~     makes them feel. They will have blood taken regularly. Every 4 weeks, they will have a~     check-up that will repeat some screening tests.~      Phase III is post-treatment. It starts with a check-up that lasts up to 2 days. Participants~     will repeat some screening tests. They will have a follow-up phone call 30 days after~     treatment ends. They will have check-ups 6 and 9 months after starting the study drug. They~     will repeat some screening tests.~      The study ends after the 9-month follow-up.~   "
30530|NCT03167424|"~     The treatment of patients with intra-stent restenosis (ISR) of Bioresorbable Vascular~     Scaffolds (Abbott Vascular) remains a challenge. This study will assess the incidence,~     predisposing factors, pathophysiology and prognosis of the patient in this setting.~   "
30531|NCT03167411|"~     The purpose of this study is to examine the drug-drug interaction in your body when given the~     study drug, bexagliflozin, with one of the most commonly prescribed glucagon-like peptide 1~     receptor agonist (GLP-1 RA) exenatide. The study will also evaluate how safe the study drug~     is and how well the study drug is tolerated when administered with exenatide injection.~   "
30550|NCT03167151|"~     A parallel group, open label, multi-centre, phase I/II marker-lesion study of intravesical or~     intravenous pembrolizumab in recurrent intermediate risk NMIBC. Thirty patients (fifteen in~     each of two arms) will be randomised 1:1 to treatment with either intravesical pembrolizumab~     (Arm A) or intravenous pembrolizumab (Arm B). The main study will be preceded by a single~     institution safety run-in phase involving intra-patient dose escalation in six patients to~     confirm the safety and tolerability of intravesical pembrolizumab and the dose to be used in~     the randomised phase.~   "
31228|NCT03158311|"~     The purpose of this trial is to demonstrate that the efficacy of two treatment arms of the~     fixed-dose combination product QVM149 is non-inferior to the efficacy of the free combination~     arm of salmeterol/ fluticasone+ tiotropium in uncontrolled asthmatics.~   "
30532|NCT03167398|"~     Antibiotic resistance has emerged world wide and is of major concern. Multi-drug resistant~     (MDR) bacteria is widely spread and is now a major factor in morbidity and mortality in~     health-care settings. Among MDRs, carbapenem-resistant Enterobacteriaceae (CRE) are of~     special concern, receiving the highest classification of urgent threat level in the US~     President Report. Consistent mortality rates of 40-50% are observed among inpatients with~     infections caused by CRE in hospitals worldwide, related mainly to unavailable, delayed or~     ineffective antibiotic treatment options.~      The extremely high mortality rates of patients with CRE infections have driven efforts to~     prevent the acquisition and spread of these bacteria in hospitals. These include screening~     for carriage, contact isolation of carriers, cohorting, dedicated healthcare staff and other~     infection control measures. These strategies have been proven as effective but are cumbersome~     and expensive. In most locations these strategies failed to completely eradicate CRE~     endemicity.~      CRE decolonization (eradication of colonization) might offer a double benefit - reducing the~     risk for the individual carrier to develop an infection due to the resistant strain (by that,~     potentially lowering the mortality risk) and preventing the bacteria from spreading to other~     patients, exposing them to the same hazard.~      Fecal microbiota transplantation (FMT), in which fecal material enriched with commensal~     microorganisms is transferred from a healthy donor, have proven efficacy in the treatment of~     recurrent Clostridium difficile infection (CDI) in multiple trails. Major adverse events that~     has been reported so far are mostly related to the route of administration (aspiration during~     nasogastric tube administration/colonoscopy). Other adverse events include mostly GI related~     symptoms (diarrhea, nausea, belching) and are self limited and resolve in few hours. FMT~     seems to be safe and effective both in immunocompetent and immunocompromised patients.~      The high efficacy of FMT in the treatment of a multi-drug resistant pathogen such as~     Clostridium difficile, suggest that it might be an efficient tool for other MDR pathogens~     (e.g. CRE).~      The authors aim to assess the effects of FMT on colonization and clinical infections with~     CRE. The potential of FMT to restore the gut microbiome and compete with residual resistant~     strains offer a novel way to fight the current MDR epidemic.~      The authors will apply FMT on a cohort of CRE carriers in a single center in Israel. FMT will~     be given by capsules for 2 consecutive days followed by rectal sampling at predefined~     timepoint in the following 6 months.~   "
30533|NCT03167385|"~     This is a non-randomized, phase II, open label study of Apatinib Mesylate in patients with~     with locally advanced or metastatic differentiated thyroid carcinoma (DTC). The purpose of~     this study is to evaluate the efficacy and safety of apatinib in patients with locally~     advanced or metastatic differentiated thyroid carcinoma.~   "
30534|NCT03167372|"~     This study compares the effect of two N-of-1 trials on study compliance with an N-of-1~     protocol and on satisfaction with participation in an N-of-1 trial. Using within-person~     analyses, the study also compares the effect of different types of light therapy on mood,~     fatigue, sleep, physical activity, and side effects within a mild to moderately depressed~     cancer survivor population. Twenty participants will be randomized to the bright white versus~     dim red light therapyN-of-1 trial, while the remaining 10 participants will be randomized to~     a dim white versus dim red light comparator N-of-1 trial.~   "
30535|NCT03167359|"~     As the number of breast cancer (BrCA) survivors has markedly increased, clinicians are now~     seeking to reduce treatment-related toxicities and inconveniences of treatment, namely the~     traditional 6 weeks of daily radiation treatment (XRT). Skin thickening, fibrosis, and edema~     are some of the most common acute and potentially long-term debilitating toxicities of BrCA~     XRT.~      The purpose of this study is to learn if three weeks of daily radiation treatment (RT) to the~     breast is safe in breast cancer patients who are usually prescribed 6 weeks of daily~     radiation after breast surgery (e.g. lumpectomy or mastectomy) as standard of care.~   "
30536|NCT03167346|"~     To investigate public awareness of core stroke symptoms in more than 40 years old population~     and its related factors.~   "
30537|NCT03167333|"~     To determine whether platelet-rich-plasma (PRP) or HA (hyaluronic acid)injection into~     synovitis in osteoarthritis(OA) knee can achieve improvement in knee function and reduce~     synovitis.~   "
30538|NCT03167320|"~     The Low Von Willebrand in Ireland Cohort (LoVIC) study focuses on the bleeding phenotype and~     biological mechanisms underlying low Von Willebrand Factor (VWF) levels.~   "
30539|NCT03167307|"~     This study investigates the therapeutic efficacy and safety of omega-3 fatty acids rich in~     eicosapentaenoic acid / docosahexaenoic acid in pediatric depression in a nine months~     double-blind multi-centre study in 220 children and adolescents between 8 and 17 years of~     age. Inflammatory and bioactive lipid markers as predictors of response are evaluated. The~     relationship between omega-3 fatty acids with psychopathology, illness course and cognitive~     parameters will be further investigated.~   "
30540|NCT03167294|"~     Single-arm prospective, interventional clinical trial. Results will be compared to a~     historical control in the treatment of benign prostatic hyperplasia~   "
30541|NCT03167281|"~     Chest tubes are used for air or fluid removal from the pleural space. When a chest tube is~     placed, it can be hard for the fluid to drain.Tissue plasminogen activator (tPA) and DNase~     are given through the chest tube to help with draining the fluid. We are doing this research~     to see if early addition of tPA-DNase immediately after chest tube placement will help with~     better fluid draining.~   "
30542|NCT03167268|"~     Background and rationale: EGFR represents the main and more studied signal activation pathway~     in the development of colorectal carcinoma. KRAS, NRAS, BRAF and PI3KA mutations and ERBB2~     and MET amplification are responsible for most of the cases of primary resistance to~     anti-EGFR antibody treatments. Despite the identification of these resistance mechanisms, a~     primary resistance to the therapy was detected in a certain percentage of cases, in which~     tumour bio-molecular characteristics would suggest a possible response to anti-EGFR antibody~     treatment. In these cases, pathway activation mechanisms should exist, which act in an~     alternative, complementary or parallel way than the EGFR one, allowing tumour progression~     despite of EGFR pharmacological deactivation. Skin toxicity is a characteristic of drugs~     having EGFR as a target and it shows itself mainly as a sterile acneiform folliculitis~     together with neutrophils perifollicular infiltrates but also as skin xerosis and paronychia~     starting from the earliest cycles of treatment. This skin toxicity seems to be closely~     related to EGFR activation of pro-inflammatory cytokines able to activate specific~     inflammatory activators, which induce neutrophils granulocytes chemotaxis. Lycopene is a~     compound belonging to carotenoid group, largely contained in tomatoes and their derivatives,~     which has an extreme antioxidant activity. In Dermatology, prolonged use of β-carotenoids in~     general and of lycopene in particular in the diet showed to be effective in skin protection~     from ageing, sunlight and radiotherapy damages because these compounds may accumulate in skin~     and thus contribute to reduce free radicals and inflammation effects. Moreover, lycopene~     ability to induce apoptosis and to inhibit cell cycle progression in some types of tumour~     cells, both in vitro and in vivo, has already been described. Lycopene seems to be able to~     suppress significantly PCNA (Proliferating cell nuclear antigen, cofactor of DNA~     polymerase-β) and β-catenin nuclear expression in neoplastic cells, essential substrate of~     WNT/β-catenin pathway, which is itself closely connected to activating pathways often~     involved in carcinogenesis of some kinds of tumours, in particular of colorectal carcinoma,~     like Akt/GSK3β/β-catenin and Hippo pathways. For its proved skin anti-inflammatory activity~     as powerful free radicals scavenger, lycopene, which accumulates itself specifically in skin,~     could be effective in reducing anti-EGFR drugs toxicity. Contemporary use of lycopene could~     have a positive effect on anti-EGFR drugs treatment effectiveness in patients with metastatic~     colorectal carcinoma due to its ability to interfere with pathways involved in neoplastic~     cells proliferation.~      Estimated population:100 patients (50 for each of the two groups of treatment)~      Study Framework: In this study, patients suffering from metastatic colorectal cancer and~     submitted to therapy with panitumumab would be enrolled. According to indications,~     panitumumab would be used:~      in first line combined with Folfox or Folfiri;~      in second line combined with Folfiri or treatments containing Irinotecan~      in monotherapy in any therapeutic line in patients resistant to Fluoropyrimidines,~     Oxaliplatin and Irinotecan or intolerant to these drugs.~      Standard schedules of these treatments would be used.~      This is a phase-II, randomized, double-blind study between experimental prophylactic~     treatment with Lycopene vs placebo:~        -  Treatment A - lycopene tablets 20 mg~        -  Treatment B - placebo tablets~      Patients should take orally Lycopene/placebo after dinner (to promote its absorption),~     starting the day before the beginning of treatment with panitumumab for the entire duration~     of the therapy, until progression of the disease or definitive drug suspension for toxicity.~      Objectives of the study~      Primary objective: to assess the effectiveness of lycopene versus placebo in reducing skin~     toxicity induced by panitumumab in patients treated for metastatic colorectal carcinoma.~      Secondary objective: to assess lycopene pharmacokinetics~      Exploratory objectives: to assess lycopene effectiveness versus placebo in increasing~     panitumumab effectiveness in terms of Disease Control (DC), Objective Response (OR) and~     Stabilisation of the Disease (SD). To assess lycopene effectiveness versus placebo in~     increasing panitumumab effectiveness in terms of Progression Free Survival (PFS).~      As far as randomization is concerned, the two groups will be balanced according to sex,~     therapeutic line and institution in which patients will be treated.~   "
30543|NCT03167255|"~     This is an open-label, extension study of NS-065/NCNP-01 administered intravenously once~     weekly for an additional 72 weeks to boys with DMD who complete Study NS-065/NCNP-01-201.~   "
30544|NCT03167242|"~     This study aims to determine the most effective and tolerable dose at the shortest dosing~     regimen of the investigational drug KAF156 in combination with a solid dispersion formulation~     of lumefantrine (LUM-SDF) in adult/adolescent and pediatric patients with uncomplicated P.~     falciparum malaria.~      There is unmet medical need for anti-malarial treatment with new mechanism of action to~     reduce probability of developing resistance, and for duration shorter than 3 days of~     treatment and/or reduced pill burden.~   "
30545|NCT03167216|"~     The objective of this study is to evaluate inhibition of mast cells and the histamine 1~     receptor (H1R) for treatment of chronic prostatitis (CP) and chronic pelvic pain syndrome~     (CPPS).~   "
30546|NCT03167203|"~     The purpose of this study is to is to evaluate the occurrence of late onset (i.e., greater~     than 5 years after treatment) safety events of special interest in participants who have~     received sub-retinal transplant of human embryonic stem cell derived - retinal pigment~     epithelial (hESC-RPE) cells in an AIRM-sponsored clinical trial. The events of special~     interest are adverse events (AEs) that are presumed to have a potential causal relationship~     to the hESC-RPE cells.~   "
30547|NCT03167190|"~     Although the lumbar puncture is a common procedure and has been performed without ultrasound~     for decades, other research studies suggest that there may be some benefits to using~     ultrasound. This study intends to see whether by using ultrasound there is increased success~     rate, decreased need for additional procedures, and less discomfort during the procedure.~   "
30548|NCT03167177|"~     This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination~     therapy in subjects with melanoma who have progressed on or after chemotherapy and~     anti-PD-1/PD-L1 therapy.~   "
30551|NCT03167138|"~     Rotator cuff disease (i.e., rotator cuff tendinopathy or tear) is a common cause of shoulder~     pain in persons with chronic spinal cord injury (SCI). It usually resolves with non-operative~     treatments such as pharmacological agents and physical therapy; however, when this fails,~     rotator cuff surgery may be the only option. Autologous adipose tissue injection has recently~     emerged as a promising new treatment for joint pain and soft tissue injury. Adipose can be~     used to provide cushioning and filling of structural defects and has been shown to have an~     abundance of bioactive elements and regenerative perivascular cells (pericytes). The purpose~     of this study is to explore the safety and efficacy of autologous, micro-fragmented adipose~     tissue (Lipogems®) injection under ultrasound guidance for chronic shoulder pain in persons~     with SCI.~   "
30552|NCT03167125|"~     The overall goal of this study is to test strategies to raise rates of colorectal cancer~     screening among the Latino population in a federally qualified health center that operates~     multiple clinics. This intervention study will test automated and live prompts to a~     direct-mail fecal testing program in two phases.~      In Phase I (Years 01 - 02), the investigators will tailor and define intervention components~     using a community-based participatory research approach called boot camp translation (BCT).~     The ultimate design of the intervention will be defined by patient and provider feedback from~     BCT. The investigators will then conduct a three-arm patient-randomized comparative~     effectiveness trial in two pilot clinics to compare 1) automated prompts (i.e., automated~     phone calls, text messages) to alert and remind patients to complete screening, 2) live~     prompts (i.e., live phone calls), and 3) a combination approach of automated plus live~     prompts.~      In Phase II (Years 03 - 05), the investigators will spread and test the spread of the adapted~     intervention to additional clinics within the partnering health center using a two-arm main~     trial.~      Both phases will be guided by an advisory group of clinicians, researchers, policy makers,~     and patients.~   "
30553|NCT03167112|"~     Pancreatic cancer is a serious condition and is one of the leading cause of cancer related~     health problem. It is estimated that in 2016, 5,200 Canadians will be diagnosed with~     pancreatic cancer, and approximately 20% (1 in 5) of patients will have localized cancer~     (cancer that is limited to pancreas and there is no evidence of cancer in other parts of the~     body). Localized cancer is earlier stage of disease and surgery to remove the cancer is~     standard of care in this condition. However, recent scientific and clinical studies show that~     using the chemotherapy medication before surgery can improve the overall survival in patents~     with localized pancreatic cancer. One of these chemotherapy regimen is combination of~     fluorouracil, oxaliplatin, irinotecan, leucovorin (FOLFIRINOX) that we are going to evaluate~     its effect in this study.~      Because of promising result of this combination in more advanced stage of pancreatic cancer,~     this study is going to examine its efficiency in earlier stage of pancreatic cancer~     (localized form). Total number of participant in this study will be 20 patients with~     localized form of pancreatic cancer without any evidence of cancer in other parts of the~     body.~      Laboratory tests show that it works by slowing down the growth of cancer or may cause cancer~     cells to die. It is hoped that by shrinking the tumor size, the surgeon will be able to~     remove the cancer and improve the overall survival.~      Procedures start with 2 weeks of comprehensive evaluation. Approximately 20 eligible~     subjects, based on this study criteria, will receive 6 treatment of this regimen every 2~     weeks. Once 6 treatments have been completed, comprehensive re-evaluation procedures will be~     repeated, and subjects without disease progression or unacceptable toxicity will continue on~     their treatment based on treating team decision (surgical intervention, radiation therapy or~     continue FOLFIRINOX or different regimen). Patients then will follow with CT scan, blood test~     and physical examination every 3 months.~   "
30554|NCT03167099|"~     This study is designed to examine if immediate weight bearing on a distal femur fracture~     fixed with a primary locking plate, either a distal condylar locking plate or a LISS (less~     invasive stabilization system), is safe and promotes more rapid fracture healing than partial~     weight bearing, which is standard of care.~   "
30555|NCT03167086|"~     This study aims to compare the efficacy of a single session psychological treatment, From~     Catastrophizing to Recovery (FCR), with the current standard of care, group Cognitive~     Behavioral Therapy (CBT) specifically on individuals with chronic low back pain suffering~     from Pain Catastrophizing (PC).~   "
30556|NCT03167073|"~     Breastfed babies have significant health benefits extending beyond infancy, including lower~     rates of childhood obesity and infection. Mothers who breastfeeding also have health~     benefits, including increased rates of postpartum weight loss. Low-income women are less~     likely to breastfeed comparatively; this disparity may be due to misconceptions about~     breastfeeding benefits or poor social support. Based on survey results and focus groups of~     low-income women, the investigators designed a novel smart-phone application to confront~     barriers women perceived prevented them from breastfeeding and propose the first-ever~     randomized controlled trial describing the impact a smart phone app has on postpartum weight~     loss and breastfeeding rates among low-income women.~   "
30557|NCT03167060|"~     This study will be a randomised placebo controlled trial examining the effectiveness of using~     an intranasal evaporative cooling device (the RhinoChill intransal device) in providing~     relief of pain and symptoms of acute migraine.The treatment works by introducing cooling into~     the passageways of the nose through two small cannulas thereby cooling the local nasal tissue~     and the blood vessels which supply blood to the brain. This cooling effect will cause the~     blood vessels to constrict as well as stimulating special cold receptors that are thought to~     be involved in the relief of migraine, thereby providing both pain and associated symptomatic~     relief. In total, 90 patients randomised in a 1:1 fashio n will be recruited from three~     different NHS Trusts. The patients will have a 30-day period of data collection for their~     current migraine frequency, treatment and response to medication (with a minimum of 2~     migraine attacks recorded) before starting the treatment phase with the RhinoChill Device.~     Treatment will be for 3 migraine attacks. Only a single treatment is allowed for the first~     attack, but on the second attack the patient may deliver 2 treatments with a gap of at least~     2 hours between treatments, if indicated.~   "
30558|NCT03167047|"~     Two methods of pain control in children undergoing surgery on the groin and scrotum are~     caudal injection (a form of epidural) with local anaesthetic, and a regional nerve block (an~     injection of local anaesthetic around the nerves supplying the area). A pilot study at our~     hospital showed a significant decrease in post-operative pain and nausea and vomiting in~     these two methods when compared to intravenous morphine and local anaesthetic to the wound.~      One potential side effect from caudal injections is temporarily decreased motor power in the~     legs due to the local anaesthetic - it is thought that this might be overcome using a more~     dilute solution of local anaesthetic along with clonidine. This study is to demonstrate that~     this method is as effective as the use of a regional nerve block.~   "
30559|NCT03167034|"~     This trial will evaluate the effect of acetazolamide (375 mg per day) vs. placebo on right~     ventricular function during exercise at acute altitude exposure in patients with COPD.~   "
30560|NCT03167021|"~     The objective of this survey will be to evaluate the perception by the students (except for~     medical students, pharmacies) of community pharmacists concerning the management of cannabis~     consumption. We want to see if the student population perceives the pharmacist as the public~     health actor of choice, and if they would more easily turn to him or to another health~     professional (doctor, nurse) in case they need. Discussing possible problematic consumption~     or for a simple search for information. It will be assessed whether the pharmacist seems to~     be a good candidate and an element of choice when young adults want to take an intelligence~     approach to cannabis consumption.~   "
30561|NCT03167008|"~     -  Infertility is defined as the inability of a sexually active couple to conceive after 1~          year of regular intercourse without contraception, affects approximately 15% of couples,~          and male factors are the cause in 20% -50% of cases.~        -  Infertility of unknown origin is classified into idiopathic male infertility and~          unexplained male infertility according to semen quality.~   "
30562|NCT03166995|"~     In the current study, the investigators aimed to study:~        -  The proprioception status of patients with FMS.~        -  The effectiveness of a postural exercise program in women with fibromyalgia for 8 weeks~          (2 sessions per week), compared to a low impact aerobic exercise program on different~          parameters, such as proprioception, balance, muscle strength, flexibility and joint~          range.~   "
30563|NCT03166982|"~     The treatment of the acute phase of the complicated abscess tubo-ovarian relies on~     antibiotics more or less associated with surgical management in case of visible abscess, poor~     clinical tolerance (sepsis) and resistance to medical treatment. The CNGOF recommended in~     2012 that the tubo-ovarian abscess are not within one antibiotic, and should be drained by~     interventional radiology, preferably by transvaginal or laparoscopic.~      Furthermore the efficiency of drainage by ultrasound puncture performed vaginally was~     demonstrated. This approach tends to replace the first laparoscopy because of its less~     invasive, fast, easy to access, more acceptable and less cost compared to laparoscopy. This~     approach is recommended by the French and English colleges.~      In total, the surgery in case of ATO is necessary, it is always coupled with antibiotics.~     Several surgical approaches are possible, laparotomy, laparoscopy and ultrasound-guided~     puncture. No prospective comparative study has been done, for which we want to develop this~     study.~   "
30564|NCT03166969|"~     Retrospective study, single-center, on 171 patients, presented a cryptogenic TIA and Minor~     stroke.~      This study objective is to determine profitability of Holter 21 days for screening paroxystic~     ACFA / flutter in cryptogenic TIA/Minor stroke, and identify the predictive factors of~     discovery a paroxystic ACFA on Holter 21 days. Clinical and échocardiographics factors, and~     brain imaging (scanner and MRI) will be analyzed.~   "
30565|NCT03166956|"~     Background & Aims. Glutamine is a conditional essential amino acid that was found in reduced~     plasma amount in Intensive Care Unit (ICU) patients. The supplementations of glutamine and~     vitamin C potentially have beneficial effects on wound healing and a reduction in infection~     rate. In this investigation, enteral glutamine and vitamin C were provided for ICU patient,~     and the associated changes in proinflammatory cytokines and clinical outcomes were~     investigated.~   "
30566|NCT03166943|"~     It has been known for many years that the heart and the liver are intimately related. There~     is a mutual interaction between the function of the heart and the liver and a broad spectrum~     of acute and chronic entities that affect both the heart and the liver. Chronic hepatitis C~     virus infection affects more than 3% (170 million) of the world's population.~   "
30567|NCT03166930|"~     This study will examine the impacts of two different methods of managing MS-related~     spasticity of the lower limbs. Both interventions will be presented as group classes~     consisting of exercises to reduce spasticity. One program consists of stretching exercises,~     while the other consists primarily of range-of-motion and strengthening exercises.~   "
30568|NCT03166917|"~     Objective: Clinical application of 3D printing implant in bone defect treatment.~      Study design: multicenter randomized controlled study . Methods:patients randomly grouped~     according to register number into internal fixation and bone graft group and 3D printing~     group. Reconstruct 3D models ,evaluate models preoperatively , simulate surgery in~     computer,design 3D implant, and 3D print implants,perform surgery with 3D implants to achieve~     the greatest degree of physiological reconstruction.Evaluate surgical efficacy .~   "
30569|NCT03166904|"~     Patients with RICTOR amplified refractory solid cancer will receive vistusertib(AZD2014).~     Study-arm is composed of 27 patients.~      Vistusertib(AZD2014) 50mg BD continuous schedule of a 28 day cycle Tumour evaluation using~     RECIST 1.1 will be conducted at screening (within 28 days prior to first dose) and every 8~     weeks relative to the date of first dose, up to week 40, then every 16 weeks until objective~     disease progression (within a window of +/- 7 days of the scheduled date).~   "
30570|NCT03166891|"~     Chiauranib may stop the growth of tumor cells by blocking Aurora kinase B（Aurora~     B）、VEGFR/PDGFR/c-Kit、CSF-1R targets. This clinical trial is studying the efficacy and safety~     of chiauranib(50mg，QD，PO) works in treating patients with relapsed or refractory ovarian~     cancer, in the meantime, exploring the latent biomarkers accompany with chiauranib, as well~     as the relevancy of which and clinical benefit.~   "
30579|NCT03166774|"~     Implementation of sexual health support program in oncology department. This program is~     organized in 3 axes. One is to inform the side effects of treatment on sexual health.~      There is a counselling team (nurse, esthetician,sexologue..etc) to raise the subject with~     patient and partner .~      Finally, the oncologist continue during the treatment to evaluate the benefit of this program~     and adapt their counselling according to the needs~   "
30580|NCT03166761|"~     Comparing two different corticosteroids (dexamethasone and triamcinolone) for use in~     sacroiliac joint injections~   "
30581|NCT03166748|"~     The purpose of this RCT is to compare the clinical/radiographic outcomes of Potassium nitrate~     in polycarboxylate cement and MTA as pulpotomy biomaterials used for asymptomatic vital~     immature permanent lower first molar and this will help to clinically evaluate the use of~     alternative capping material in vital pulpotomy in young permanent teeth with pathologic~     pulpal injuries emphasis is set on avoiding total pupectomy and maintaining radicular pulp~     vitality and function and therefore maintain the tooth in a viable condition that help root~     completion.~   "
30571|NCT03166878|"~     Autologous T cells engineered to express chimeric antigen receptors (CARs) against leukemia~     antigens such as CD19 on B cells have shown promising results for the treatment of relapsed~     or refractory B-cell malignancies. However, a subset of cancer patients especially heavily~     pretreated cancer patients could be unable to receive this highly active therapy because of~     failed expansion. Moreover, it is still a challenge to manufacture an effective therapeutic~     product for infant cancer patients due to their small blood volume. On the other hand, the~     inherent characters of autologous CAR-T cell therapy including personalized autologous T cell~     manufacturing and widely distributed approach result in the difficulty of industrialization~     of autologous CAR-T cell therapy. Universal CD19-specific CAR-T cell(UCART019),derived from~     one or more healthy unrelated donors but could avoid graft-versus-host-disease (GVHD) and~     minimize their immunogenicity, is undoubtedly an alternative option to address~     above-mentioned issues. We have generated gene-disrupted allogeneic CD19-directed BBζ CAR-T~     cells (termed UCART019) by combining the lentiviral delivery of CAR and CRISPR RNA~     electroporation to disrupt endogenous TCR and B2M genes simultaneously and will test whether~     it can evade host-mediated immunity and deliver antileukemic effects without GVHD.~      The main goal of the phase 1 portion of this phase 1/2 trial is to evaluate the safety and~     tolerability of several doses of UCART019 in patients with relapsed or refractory CD19+~     leukemia and lymphoma, so as to establish the recommended dose and/or schedule of UCART019~     for phase 2 portion. The recommended Phase 2 dose will be defined as the highest dose level~     of UCART019 that induced DLT in fewer than 33% of patients (i.e., one dose level below that~     which induced DLT in at least two of six patients). Phase 2 portion of the trial will not be~     initiated until the recommended Phase 2 dose is determined. In the phase 2 portion of this~     trial, we will mainly determine if UCART019 help the body's immune system eliminate malignant~     B-cells. Safety of UCART019 and impact of this treatment on survival will also be observed.~   "
30572|NCT03166865|"~     Osteoarthritis (OA) is one of the most common joint diseases that is considered a chronic~     degenerative disorder. There is no effective therapy available today. This prospective~     clinical trial is designed in an attempt to study the efficacy of mesenchymal stem cells with~     platelet rich plasma in knee osteoarthritis.~   "
30573|NCT03166852|"~     High-intensity training (HIT) has showed beneficial effects in type 2 diabetics such as~     improved glycemic control, improved bloodpressure and more. In addition, HIT is a time-saving~     training protocol which is of importance, as lack of time often is mentioned as a reason not~     to train. The combination of the time-saving HIT-protocol and the possibility to train at~     home and still get feedback on the intensity and amount of training can be appealing for~     some. This study aims to investigate whether it is possible to train at the right intensity~     and frequency and only get feedback throug a technology.~   "
30574|NCT03166839|"~     Background: Maternal deaths occur universally and are largely avoidable. Postpartum~     haemorrhage accounts for a disproportionate amount of maternal deaths. There remains a great~     need to expeditiously decrease the rate of postpartum haemorrhage to prevent further~     mortality.~      Methods: This study is a cohort analysis of data collected for the pragmatic international~     multi-centre randomized double blind placebo controlled design WOMAN Trial. It will present a~     univariate analysis of patient and delivery characteristics (age, type of delivery, placenta~     fully delivered, primary cause of haemorrhage, severity of haemorrhage), physiologic~     characteristics (systolic blood pressure, estimated blood loss, clinical signs of~     haemodynamic instability) and management characteristics (receipt of blood products,~     uterotonics). Multivariable logistic regression models and likelihood ratio tests will be~     used to examine the evidence for interaction between death from PPH and region after~     adjusting for any independent effects of 1) systolic blood pressure 2)age 3) type of delivery~     4) receipt of blood products Discussion: This analysis of the WOMAN trial dataset will~     explore the relationship between geographical location, patient and environment~     characteristics and outcomes of postpartum haemorrhage. A protocol and statistical analysis~     plan is presented here.~   "
30575|NCT03166826|"~     Apgar scoring system has been widely used for the evaluation of the infant's postnatal~     condition. As conventional Apgar scoring system is affected by gestational age and~     resuscitative efforts, there is a need for development of new scoring systems for the~     assessment in the delivery room. Herein, Modified Combined Apgar scoring system which~     includes two new parameters (cord blood pH and targeted oxygen saturation level) has been~     developed and the utility of this modified system was compared with Conventional and Combined~     Apgar scoring systems for prediction of hospitalization.~   "
30576|NCT03166813|"~     Survival rates of children with cancers have improved significantly in the recent few~     decades. Nonetheless, the side effect of this class of drugs on heart function remains to be~     an issue of concern. Exploration of new strategies to protect the heart in the long term is~     therefore of paramount importance in children undergoing treatment of cancers. Previous~     cardioprotective interventions hav focused on changing the formulation or rate of~     administration of anthracyclines but with no observable benefits. While dexrazoxane, an iron~     chelator, has shown to reduce cardiotoxic outcomes, there remains worries of an association~     between dexrazoxane use and an increased risk of developing secondary malignancies. Recently,~     the clinical application of remote ischaemic preconditioning (RIPC) as a non-invasive and an~     easily applicable non-pharmacological myocardial protective intervention has gained~     increasing interest. Remote ischaemic preconditioning is the phenomenon in which brief~     episodes of reversible ischaemia and reperfusion applied to one vascular bed render~     resistance to ischaemia reperfusion injury of tissues and organs distant away. It can be~     achieved by repeated 5-minute cycles of inflation and deflation of blood pressure cuff placed~     over the arm or leg to induce limb ischaemia and reperfusion injury. It is noteworthy that~     anthracycline cardiotoxicity and myocardial reperfusion injury occur through similar~     pathways. Hence, the investigators hypothesize that RIPC may reduce myocardial injury in~     children receiving anthracycline chemotherapy for childhood malignancies. The proposed study~     aims to conduct a parallel-group blinded randomized controlled trial study to investigate~     whether RIPC may reduce heart damage in childhood cancer patients undergoing~     anthracycline-based treatment, and to determine the effect of RIPC on the changes in levels~     of cardiac troponin T, and on the occurrence of clinical cardiovascular events and~     echocardiographic indices.~   "
30577|NCT03166800|"~     The purpose of this study is to determine whether MS patients who receive Oral mitoquinone~     (MitoQ) have less fatigue than those receiving a placebo. A comparison between patient's~     fatigue scored at baseline and fatigue scored 12 weeks after drug initiation will assess if~     MitoQ has a significant change in fatigue.~   "
30578|NCT03166787|"~     Hookah (water pipe) smoking is a new global epidemic. The World Health Organization wants to~     prohibit all claims that hookah is less harmful than cigarettes and wants hookah products to~     bear the same warning labels as cigarettes. But there is little scientific evidence to~     substantiate this proposal. Cigarettes, cigars, medicinal nicotine, and e-cigarettes all~     acutely impair brachial artery endothelial function (flow-mediated dilation, FMD). Also,~     cigarettes cause both acute and chronic impairment in coronary endothelial function, but the~     comparative effects of hookah are unknown. Hookah tobacco is heated with burning charcoal.~     So, the smoke contains tar and nicotine plus charcoal combustion products. These include~     carbon monoxide (CO) and proatherogenic oxidants (especially carbon-rich nanoparticles) that~     the study team expected to impair endothelial function.~   "
41350|NCT03025490|"~     The study sets out to assess whether in the context of nurse administered procedural sedation~     in the electrophysiology suite, the routine use of capnography and Integrated Pulmonary Index~     results in lower incidence of severe adverse respiratory events.~   "
30582|NCT03166735|"~     The primary objective of this study is the proof of mechanism and support of dose finding,~     together with the safety evaluation in patients with clinical evidence of NASH.~      To gain further insight into clinical effects of AOC3 inhibition on NASH further exploratory~     analyses of biomarkers related to NASH and liver fibrosis will be performed. This will~     include the effect of BI 1467335 on reduction of secondary biomarker endpoints (ALT, AST, AP,~     γ-GT and CK18 fragments). Safety will be assessed throughout the study to provide key~     information regarding the use of BI 1467335 in patients with NASH.~   "
30583|NCT03166722|"~     The aim of the COSGOD Phase III trial is to examine, if it is possible to increase survival~     without cerebral injury in preterm neonates <32 weeks of gestation by monitoring the cerebral~     tissue oxygen saturation in addition to routine monitoring of arterial oxygen saturation and~     heart rate and specified clinical treatment guidelines during immediate transition period~     after birth (the first 15 minutes).~   "
30584|NCT03166709|"~     The goal of this study is to evaluate the effectiveness and utility of the investigator's~     National Institute on Drug Abuse (NIDA) R21 developed Preventing Addiction Related Suicide~     (PARS) program by utilizing a novel stepped wedge design to evaluate PARS as a selected~     prevention program to increase help-seeking by clients in community addiction treatment.~   "
30585|NCT03166696|"~     A registry of consecutive patients who were admitted and diagnosed with acute myocardial~     infarction or acute cerebral infarction were conducted at the Guangdong General Hospital or~     the First Affiliated Hospital of Guangzhou University of Chinese Medicine, Yue Bei People's~     Hospital, China, between January 2000 and December 2016. The adverse clinical outcomes,~     including all-cause mortality, were followed from the date of admission for acute myocardial~     infarction or acute cerebral infarction until study end (December 31, 2016). All-cause~     mortality, including the date of death, was identified from the electronic hospitalization~     data, phone follow-up, and confirmed by the household registration (HUKOU) system, a record~     of registration required by law in China. Baseline characteristics, including major treatment~     of acute myocardial infarction or acute cerebral infarction, estimated glomerular filtration~     rate (eGFR) and proteinuria, were collected. Demographic data were determined from the~     electronic hospitalization data and electronic hospital discharge records. All comorbid~     conditions were identified using International Statistical Classification of Diseases, Tenth~     Revision (ICD-10), coding algorithms applied to electronic physician claims and electronic~     hospital discharge records. Life style (smoking), treatment regimen at discharge, including~     angiotensin-converting enzyme inhibitor (ACEI), angiotensin II receptor blocker (ARB), were~     determined from the electronic hospitalization data.~   "
30586|NCT03166683|"~     This multicentre prospective and randomized study aims to compare the sealant effect after~     surgical liver resection of a new collagen - polyethylene glycol hemostatic / sealant patch~     (Hemopatch) vs standard of care.~   "
30587|NCT03166670|"~     Diarrhea is one of the most common reasons for people to seek medical advice - but it can~     range from being a mild, temporary condition, to be life threading condition. It is estimated~     that there are 2 billion cases of diarrheal disease every year globally, and that 1.9 million~     children below the age of 5 years, mostly in developing countries, die annually.~   "
30588|NCT03166657|"~     All women with history of secondary infertility after caesarean section will be subjected to~     office hysteroscopy according to Royal college of obstetrics and gynecology guidelines to~     diagnose any subtle uterine abnormalities not detected by conventional means.~      Hysteroscopic examination will be done during the proliferation phase of the menstrual cycle.~      The hysteroscopic evaluation will include assessment of the cervical canal, intrauterine~     lesions, the endometrium and the uterotubal junction. .~      If hysteroscopy reveal a lesion, its type, size, location will be recorded. Transvaginal~     ultrasound will be done after the procedure to detect fluid in the douglas pouch to confirm~     patent tubes.~      Asses the uterine scar in details.~   "
30589|NCT03166644|"~     To determine whether a treatment strategy targeting an individualized sufentanil~     administration based on the Analgesia Nociception Index (ANI) could reduce the total dose of~     sufentanil during major abdominal surgery, as compared with standard practice.~   "
30590|NCT03166631|"~     The main objective of the dose-escalation parts of the trial is to determine the maximum~     tolerated dose (MTD), based on the frequency of patients experiencing dose-limiting~     toxicities (DLTs), and/or the recommended dose for further development of BI 891065~     monotherapy as well as of BI 891065 in combination with BI 754091, and to evaluate its safety~     and tolerability by monitoring the occurrence and severity of adverse events (AEs).~      Secondary objectives are the determination of the pharmacokinetic (PK) profile of BI 891065~     monotherapy as well as of BI 891065 in combination with BI 754091, and the preliminary~     assessment of anti-tumour activity.~   "
30591|NCT03166618|"~     This study will evaluate the safety and effectiveness of JUVÉDERM VOLUMA XC injectable gel in~     adult participants seeking correction of temple hollowing.~   "
30592|NCT03166605|"~     Wireless video capsule endoscopy (VCE) is a non-invasive technology that looks into small~     intestine and gives images of its lumen as the wireless capsule passes through it. It is used~     widely to access this anatomically difficult part of the body that cannot be seen via either~     colonoscopy or endoscopy. Currently various studies have been done that give multiple~     comparisons between various bowel preparation in terms of quality of the small bowel~     visualization. No studies have been done where simethicone (Gas-X) is ingested after capsule~     swallowing. We intend to give patients simethicone 1 hour after capsule ingestion for two~     consecutive hours and compare results of capsule endoscopy outcomes like small bowel transit~     time (SBTT), diagnostic yield (DY), small bowel visualization quality (SBVQ) and completion~     rate (CR).~   "
30593|NCT03166592|"~     Although the Magnetic resonance imaging with contrast is the gold standard for diagnosis of~     intra axial brain masses. The conventional Magnetic resonance imaging appearances of intra~     axial brain masses can be non-specific and even the use of contrast agent is of limited~     benefit.~      Contrast enhancement reflects only disruption of blood brain barrier. One third of high-grade~     malignancies are non-enhanced and may non-neoplastic lesions show contrast enhancement.~      Reliable differentiation of neoplastic from non-neoplastic brain masses, or of high grade~     from low grade tumor, is difficult with conventional Magnetic resonance imaging~   "
41351|NCT03025477|"~     CHIMOVIP is a study to determine the best therapeutic strategy in patient with ovarian~     advanced cancer.~   "
30594|NCT03166579|"~     This study aims to evaluate the effectiveness of Dialectical Behaviour Therapy for adults~     with Borderline Personality Disorder attending Community Mental Health Services in Cork,~     Ireland.~      The main objective of the current study is to determine if completion of a 12 month DBT~     programme is associated with improved outcomes in terms of borderline symptoms, anxiety,~     hopelessness, suicidal behaviour, depression and quality of life.~      A secondary objective includes assessing client progress across multiple time-points~     throughout the treatment.~   "
30595|NCT03166566|"~     Purpose: To assess the feasibility of a surgical technique and present the preliminary safety~     results of a new glaucoma device devoid of a tube in painful blind eyes.~      Methods: Fifteen end-stage glaucomatous eyes without light perception vision were treated~     with a novel laminar drainage implant. Intraocular pressure was measured preoperatively and~     up to 24 months after surgery using a Goldmann applanation tonometer. A scale ranging from 0~     to 10 was used to evaluate ocular pain. Conjunctival hyperemia, discharge, erosion or~     retraction, aqueous humor leakage, corneal edema, hyphema, anterior chamber cells and depth,~     dislocation of the implant, and filtering bleb height were assessed by slit-lamp~     biomicroscopy. Anterior segment optical coherence tomography was also assessed.~   "
30596|NCT03166553|"~     Clinical Trial of Elemene Injection/Elemene Oral Emulsion in Combination with Systematic~     Chemotherapy including Oxaliplatin in the First -line treatment of advanced primary liver~     cancer~   "
30597|NCT03166540|"~     The aim of this study will be to define the bioavailability and the beneficial properties of~     coffee bioactive compounds. Moreover, the contribution of cocoa-based products containing~     coffee to the pool of circulating metabolites will be investigated with the aim of evaluating~     the effect of the combination of bioactives from different sources.~      To study the bioavailability of coffee/cocoa bioactive compounds and their effects in~     cardiometabolic health, the objectives will be:~      i) Assessing the bioavailability of the four main groups of phytochemicals in roasted coffee~     (methylxanthines, phenolic compounds, trigonelline, and diterpenes), its modulation by the~     level of consumption, and establishing the daily average concentration of coffee-derived~     plasma circulating metabolites; ii) Investigating the effect of different levels of coffee~     consumption on cardiometabolic risk factors; iii) Evaluating circulating metabolites and~     their putative bioactivity when substituting coffee consumption with the intake of~     cocoa-based products containing coffee.~      A 3-arm, crossover, randomized trial will be conducted. Twenty-one volunteers will be~     randomly assigned to consume three treatments in a random order for 1 month: 1 cup of~     espresso coffee/day, 3 cups of espresso coffee/day, 1 cup of espresso coffee at breakfast and~     2 cocoa-based products containing coffee two times per day. The last day of the treatment~     subjects will refer to the ambulatory where blood and urine samples will be collected at~     specific time points up to 24 hours following the consumption of the testing coffee or of the~     cocoa-based products containing coffee. In addition to the bioavailability of the bioactive~     compounds, the effect of the coffee consumption on several cardiometabolic risk factors~     (blood pressure, anthropometric measures, inflammatory markers, nitric oxide, blood lipids,~     fasting indices of glucose/insulin metabolism, DNA damage, eicosanoids, nutri-metabolomics)~     will be investigated. At the end of the treatment, the same protocol will be repeated,~     switching the allocation group.~   "
30598|NCT03166527|"~     Chronic inflammatory demyelinating polyneuropathy (CIDP) is a treatable form of peripheral~     neuropathy with suspected autoimmune cause. The current first-line treatment is IVIG (immune~     globulin), which is infused in a set regimen that requires 4-5 hours in a hospital day unit,~     taking up resources such as nursing time and hospital space. Chronic treatment is required in~     most cases.~   "
30599|NCT03166514|"~     The purpose of this study is to examine the glucose and insulin response to a food bar.~   "
30600|NCT03166501|"~     This Phase 1b study examines the safety and efficacy of parenterally-administered lanicemine~     in a parallel-arm, randomized, double-blind, placebo-controlled trial in adult patients~     (N=24) with significant PTSD symptoms and elevated anxiety potentiated startle (APS).~     Investigator hypothesize that lanicemine (100 mg) displays a normalization of APS following~     three infusions over 5 non-consecutive days. If target engagement is demonstrated and the~     drug is safe and tolerable in this patient population, investigator will proceed to a larger~     POC study.~   "
30601|NCT03166488|"~     The purpose of this study is to look at liver stiffness with a MRI sequence called Magnetic~     Resonance Elastography (MRE). The study will let the investigators know whether the subject's~     liver is normal or has increased stiffness. Increased liver stiffness often means there is~     chronic liver disease and fibrosis. Increased right heart pressure and congestive heart~     failure are considered risk factors for development of liver fibrosis. Liver fibrosis, if~     progressive, may lead to cirrhosis and its related complications. The increased liver~     stiffness may be due to a poorly functioning tricuspid valve. With this research, the~     investigators will be able to determine if the elevated stiffness of the liver returns to~     normal after the surgeon performs a repair or replacement of the tricuspid valve.~   "
30602|NCT03166475|"~     A prospective randomized controlled trial of 30 patients from the Faculty of Dentistry of the~     UFJF was conducted. It was included patients who presented indication of extraction of~     premolars, canines or incisors. All the thirty patients underwent dental extraction and were~     randomly divided into three groups according to the study methodology. Plaster casts and~     Cone-Beam Computed Tomography (CBCT) exams were performed for comparative analysis between~     sample groups and between study times ( imediate postoperative and four months later).~   "
30603|NCT03166462|"~     Demand for Total Knee Arthroplasty (TKA) and Total Hip Arthroplasty (THA) is increasing~     steadily and is projected to continue trending upwards in the coming years. Concomitant with~     that trend is the increase in prevalence of obesity. Obesity serves as a common risk factor~     for osteoarthritis, obstructive sleep apnea and medical complications.~      Obstructive Sleep Apnea (OSA) is defined as episodes of obstructive apneas and hypopneas~     during sleep, with daytime somnolence. It occurs commonly in obese, middle age and elderly~     men and has an estimated prevalence of 5% - 9%.~      Pre-operative screening for elective surgical procedures is a critical component of a~     successful surgical outcome. Patients with medical comorbidities ideally will undergo medical~     treatment or optimization to minimize the risk peri-operatively and post-operatively.~     Obstructive sleep apnea has been shown in numerous studies to be a risk factor for~     cardiopulmonary complications following surgery. The contributing factors include alterations~     in REM sleep post-operatively and opioid induced respiratory suppression post-operatively.~      The STOP-BANG patient questionnaire is a validated patient survey that uses both objective~     and subjective data to screen patients for their risk of OSA. The sensitivity of the~     STOP-BANG questionnaire for moderate-to-severe OSA has been estimated as high as 97.74%.~     Authors have also shown that higher STOP-BANG scores are independently associated with~     increased risk for post-operative complication.~      Other authors have utilized similar pre-operative questionnaires to screen for occult~     pulmonary disease in patients scheduled for elective joint arthroplasty. They found a~     slightly increased incidence of OSA in this population as compared with the national average,~     over 50% of which were previously undiagnosed.~      The American Society of Anesthesiologists task force on perioperative management of patients~     with OSA published extensive guidelines aimed at reducing morbidity and mortality. Improved~     diagnosis pre-operatively could aid in proper compliance with these guidelines. These~     recommendations include preferential use of regional analgesia, reduction in systemic~     opioids, monitoring of oxygen saturation and nonsupine posture.~      The mainstay of treatment for OSA is a positive pressure airway device such as Continuous~     Positive Airway Pressure (CPAP) or in severe cases Nasal Intermittent Positive Pressure~     Ventilation (NIPPV). Post-operatively continuation of these treatments in patients with known~     OSA is often recommended. Some authors have demonstrated reductions in Apnea-Hypopnea Index~     postoperatively through the use of CPAP.~      However, a recent meta-analysis evaluating the effect of pre-operative or post-operative CPAP~     in patients with OSA concluded that the use of CPAP did not reduce post-operative adverse~     events.~      Given the projected increase in demand for joint arthroplasty, the ever-increasing incidence~     of obesity, the ambiguity surrounding the topic and the potential to clinically impact~     post-operative morbidity, mortality and health care costs, shows the need for further~     studies.~   "
30604|NCT03166449|"~     Background: Head injury is one of the top three diagnosis leading to intensive care unit~     (ICU) admission in Malaysia. There has been growing interest in using immunonutrition as a~     mode of modulating the inflammatory response to injury or infection with the aim of improving~     clinical outcome. The aim of the present study was to evaluate the effect of an~     immunonutrition on biomarkers (IL-6, glutathione, CRP, total protein and albumin) in~     traumatic brain injury patients.~      Methods: Thirty six patients with head injury admitted to neurosurgical ICU in University~     Malaya Medical Centre were recruited for this study, over a 6-month period from July 2014 to~     January 2015. Patients were randomized to receive either an immunonutrition (Group A) or a~     standard (Group B) enteral feed. Levels of biomarkers were measured at day 1, 5 and 7 of~     enteral feeding.~      Results: Patients in Group A showed significant reduction of IL-6 at day 5 (p<0.001) with~     concurrent rise in glutathione levels (p= 0.049). Patients in Group A also demonstrated a~     significant increase of total protein level at the end of the study (day 7).~      Conclusion: These findings indicate the potential of immunonutrition reducing cytokines and~     increasing antioxidant indices in patients with TBI. However, further studies incorporating~     patient outcomes are needed to determine its overall clinical benefits.~   "
30692|NCT03165305|"~     Sustained inflation (SI) has been reported to be effective for reducing the need for~     intubation and/or invasive ventilation in preterm infants. However, it has also an important~     role to support the initial breaths and liquid removal from the airways. Therefore, the~     investigators hypothesized that SI performed just after birth may help to facilitate the~     transitional period and decrease the incidence of early respiratory morbidities such as~     transient tachypnea in term infants.~   "
30605|NCT03166436|"~     Pancreatic cancer and cholangiocarcinoma are the most common causes of malignant biliary~     obstruction. They are diseases of increasing incidence and unfavorable prognosis. Only a~     minority of patients have a localized disease and are indicated for surgery with a chance of~     long-term survival. Locally advanced and metastatic tumors are treated with palliative~     chemotherapy or chemoradiotherapy; the results of such treatments are unsatisfactory. The~     average survival of patients with unresectable disease is 6 months and only 5 - 10 % of~     patients survive 5 years. Chemotherapy and radiotherapy can be used, however only with a~     palliative effect. Biliary drainage is an integral part of palliative treatment.~     Endoscopically or percutaneously placed stents improve quality of life, decrease cholestasis~     and pruritus, but do not significantly improve survival. Biliary stents get occluded over~     time, possibly resulting in acute cholangitis and require repeated replacement. Endoluminal~     biliary photodynamic therapy (PDT) and radiofrequency ablation (RFA), locally active~     endoscopic methods, have been increasingly used in recent years in palliative treatment of~     patients with malignant biliary obstruction. In photodynamic therapy, improved survival has~     been shown in two randomized controlled trials; however the technique suffers from technical~     complexity, high cost and low availability. In RFA, application of low voltage high frequency~     current during radiofrequency ablation results in tissue destruction by heat. Its antitumor~     effect may also be related to systemic changes in antitumor immunity. The use of endoluminal~     biliary RFA has so far been reported only in small retrospective cohorts of patients.~      The aim of this randomized study is to compare efficacy of RFA plus stenting to stenting~     alone in palliative treatment of malignant biliary obstruction with survival as primary~     outcome. Secondary outcomes are stent patency, immediate and late complications, quality of~     life and effects on anti-tumor immunity in the RFA group.~   "
30606|NCT03166423|"~     The primary objective is to evaluate the efficacy and safety of the use of a formulation of~     snail slime and natural extracts, for the curative treatment of ulcer wonds in diabetic foot.~      The secondary objetives:~        1. To evaluate the efficacy of the use of a formulation of snail slime Helix aspersa Müller~          and natural extracts (MU001) for the curative treatment of ulcer wonds in diabetic foot~          with respect to the standard of care, by means the application of patchs that containing~          the formulation in a treatment period of until 60 days.~        2. To determine the safety of the use of a formulation of snail slime Helix aspersa Müller~          and natural extracts (MU001) in diabetic individuals in a treatment period of until 60~          days.~   "
30607|NCT03166410|"~     This study will examine the safety and efficacy of autologous adipose-derived stromal~     vascular fraction (SVF) cells for treatment of hip, knee and thumb osteoarthritis (OA);~     monitoring adverse events and measuring pain, function and stiffness in the joints of~     osteoarthritic subjects.~   "
30608|NCT03166397|"~     Adoptive cell therapy (ACT) with tumor-infiltrating lymphocytes (TILs) in combination with~     lymphodepletion and high-dose interleukin 2 (IL-2) has demonstrated reproducible objective~     response rates of approximately 50 percent in patients with highly advanced, refractory~     metastatic melanoma.~      Recent developments in theTIL ACT procedure facilitate the use of a reduced-intensity,~     non-myeloablative, lympho-depleting preparative regimen which is expected to be both less~     toxic and equally efficient compared to previous regimens.~   "
30609|NCT03166384|"~     There was no study about application of electrosurgical bipolar sealing device for mastectomy~     in Korean population, because Korean national insurance did not cover use of the advanced~     sealing device until last year. Sample size of the previous studies was too small to draw a~     solid conclusion. Therefore, this study was designed prospectively to evaluate whether~     application of bipolar energy device for mastectomy could provide clinical benefit in terms~     of reducing seroma formation.~   "
30610|NCT03166371|"~     The purpose of this study is to see if oral liquid glutathione treatment, has any effect on~     improving health-related cellular protection, muscle size and strength, and fatigue,~     weakness, and quality of life in older adults with a history of malnutrition who have been~     hospitalized. Persons enrolled in this study will be those initially admitted to Emory~     University Hospital (EUH) in Atlanta, GA, but recovering and ready to be discharged home or~     to an assisted living facility to eat an oral diet. A combination of nutritional measures,~     blood markers and imaging tools will assess body composition. Study participants will~     complete questionnaires about quality of life and physical health, and do simple testing for~     physical strength and stamina. Information from this pilot study will increase understanding~     of a simple intervention which may prevent or reduce health risks related to hospital~     recovery in older adults.~   "
30611|NCT03166358|"~     This study will determine the efficacy of an 8-week Hatha yoga intervention for adolescents~     with tension-type headache (TTH) and will assess theoretically-driven mediators of treatment~     response, including experimental pain sensitivity, chronic stress, and negative cognitions~     linked to chronic pain.~   "
30612|NCT03166345|"~     Platelets rich plasma is simple source of growth factors and cytokines that can regulate~     endometrial growth for subgroup of thin endometrium women. It is an autologous source of this~     enhancing factors; therefore, there os no risk of using it within the same participant.~   "
30613|NCT03166332|"~     High risk women for growth restricted fetuses will randomized in the second trimester into~     different strategies applied to the mothers: a stress reduction program based on mindfulness~     techniques or a nutrition interventional program based on Mediterranean diet.~   "
30614|NCT03166319|"~     This is a prospective pilot study to determine the utility of MRI and high resolution~     intracranial vessel wall imaging for the diagnosis and disease activity assessment of~     intracranial vasculitis.~   "
30615|NCT03166306|"~     Pulmonary arterial hypertension (PAH) is a disorder of elevated pulmonary vascular resistance~     characterized by progressive remodeling and obliteration of vessels of the distal pulmonary~     circulation. Outcomes in PAH could be improved with earlier diagnosis, and with the early~     deployment of therapies before irreversible changes have occurred. This study tests the~     sensitivity of positron emission tomography (PET)-CT scanning with [89Zr]-bevacizumab, a~     radioisotope-conjugated anti-VEGF antibody for detecting pulmonary vascular remodeling in PAH~     disease. This test could enable non-invasive diagnosis early in the course of the disease,~     and potentially improve outcomes in PAH,~   "
30616|NCT03166293|"~     This is a randomized controlled trial comparing 3 months of intensive leg exercise to~     standard physiotherapy care for the improvement of motor function in the legs in young~     children with spastic diplegia.~   "
30630|NCT03166111|"~     Long-acting reversible contraception methods are highly effective methods for reduction of~     the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that~     provides reliable, effective and long term contraception for many women. However, the~     insertion procedure can be associated with a troublesome degree of pain that prevent some~     women from choosing its use. Different interventions have been described to decrease pain~     perception during intrauterine device insertion with no agreement on an effective one.~     Pre-insertion oral ibuprofen, diclofenac, nitroprusside, local anesthetics as lidocaine and~     prostaglandins has been reported with variable degrees of success .~   "
30617|NCT03166280|"~     HCV is associated with vitamin D deficiency. Iron overload is frequently occurred in chronic~     hepatitis C patients; more than one third of HCV positive patients have elevated serum iron,~     ferritin, and transferrin which were linked to bad prognosis. Hepcidin is a regulatory~     peptide that is mainly synthesized by the liver cells and plays an important role in iron~     homeostasis. There is an interaction between iron metabolism and vitamin D metabolism. Iron~     is essential for vitamin D activation and vitamin D deficiency is associated with elevated~     hepcidin level, which partly accounts for anemia associated with vitamin D deficiency. Up to~     our knowledge, little is known about the association between vitamin D status and iron~     metabolism in HCV patients.~   "
30618|NCT03166267|"~     In this prospective case series patients with a tibial fracture are monitored with smart~     biofeedback systems to document the healing progression and real life weight.~   "
30619|NCT03166254|"~     Metastatic non-small cell lung cancer (NSCLC) is incurable with current therapies, but due to~     mutations induced by cigarette smoke, typically expresses a large number of altered proteins~     that can be recognized as foreign by the immune system. This antigenicity is thought to~     explain the efficacy of pembrolizumab as either a first or second line treatment in this~     disease. For patients who receive chemotherapy as a first line therapy, there is sound~     rationale for combination treatment with immunotherapy and a therapeutic antitumor vaccine as~     a maintenance strategy. Regardless of PD-L1 expression in the tumor, monoclonal antibodies~     that block PD-1/PD-L1 interactions are effective second line therapies after chemotherapy. In~     addition, by targeting the immune system against tumor specific antigens using a peptide~     vaccine, the efficacy of pembrolizumab alone is expected to be enhanced, with an improved~     response rate and prolonged overall survival with no additional toxicity.~      This pilot study will provide a preliminary test of the feasibility of generating a~     personalized, tumor neoantigen-specific therapeutic vaccine and the safety of combining it~     with checkpoint blockade immunotherapy.~   "
30620|NCT03166241|"~     Adverse cutaneous drug reactions are undesirable and typically unanticipated reactions~     independent of the intended therapeutic purpose of a medication. It may be either immunologic~     (eg, drug allergy) or non-immunologic. Adverse cutaneous drug reaction produce a wide range~     of clinical manifestations such as pruritus, maculopapular eruptions, urticaria, angioedema,~     phototoxic and photo allergic reactions, fixed drug reactions, erythema~     multiforme,vesiculobullous reactions (eg, Stevens-Johnson syndrome and toxic epidermal~     necrolysis) and serum sickness .They must be considered in the differential diagnosis of~     sudden symmetric eruption~   "
30621|NCT03166228|"~     Hysteroscopy is a minimally invasive gynaecological procedure in which an endoscopic optical~     lens is inserted through the cervix into the endometrial cavity to assists in the diagnosis~     of a vast number of uterine pathologies Historically, urologists used the resectoscope to~     perform a transurethral prostatectomy. This instrument was later modified to accommodate~     gynaecological applications. Operative hysteroscopy became popular after improvements in~     endoscopic technology and instruments in the 1970s and after the introduction of fluid~     distension media in the 1980s (1). During the past 2 decades, hysteroscopy has been~     increasingly used for operative procedures~   "
30622|NCT03166215|"~     The purpose of this study is to characterize the multiple-dose safety and tolerability~     profile of TAK-935 in adult participants with developmental and/or epileptic~     encephalopathies.~   "
30623|NCT03166202|"~     Previous work collectively suggests that rod-mediated dark adaptation (RMDA) is a promising~     candidate as a functional endpoint measure for evaluating interventions to slow early~     progression of age-related macular degeneration (AMD). However, there is no agreement among~     the clinical, research and regulatory communities as to what constitutes a clinically~     (practically) significant slowing in RMDA. Treatments for AMD are often not considered~     efficacious if they do not result in a criterion level of improvement in vision. But how much~     change in the rate of dark adaptation constitutes a clinically significant change? Until this~     issue is resolved, progress in developing clinical trials on early AMD are at a standstill~     since there is no functional endpoint to be used in the trial. One approach to establishing~     clinical significance is to examine how RMDA relates to the performance of an everyday visual~     task under low luminance conditions, such as night driving or reading. However, such data are~     not yet available. The purpose of this project is to examine the relationship between RMDA~     and night-time driving and reading under poor illumination. This information will guide the~     development of a definition of a clinically significant difference in RMDA that can be used~     in designing clinical trials on early AMD.~   "
30624|NCT03166189|"~     Investigators will examine safety and efficiency of the cell product of autologous bone~     marrow-derived mesenchymal stem cells (MSC) for patients with repeated IVF failures and~     hypoplastic or/and fibrosis process of endometrium~   "
30625|NCT03166176|"~     Patients with TSC1/2 mutated refractory solid cancer will receive vistusertib(AZD2014)~     monotherapy. Study-arm is composed of 27 patients. Vistusertib(AZD2014) 50mg BD continuous~     schedule of a 28 day cycle as a monotherapy~   "
30626|NCT03166163|"~     i will compare the effect of neem extract mouthwash versus the chlorhexidine mouthwash on~     bleeding on brushing among a group of Egyptian children.~   "
30627|NCT03166150|"~     The purpose of this study is to improve urinary incontinence in older women by building~     strength in the pelvic and lower body muscle through exercise and rehabilitation. The study~     will also look at quality of pelvic floor and lower extremities muscles using MRI (Magnetic~     Resonance Imaging).~   "
30628|NCT03166137|"~     Viral warts are common skin conditions seen in both children and adults. Human papilloma~     virus is responsible for verrucae. Cutaneous manifestation of the human papillomavirus, are~     extremely common particularly on the hands and feet. Warts can induce hard, thickened skin,~     black pinpoints, pain or tenderness with significant morbidity for the patients.~   "
30629|NCT03166124|"~     The purpose of this study is to compare LY900014 with insulin lispro in elderly and younger~     adults with type 1 diabetes mellitus.~      Screening is required within 28 days prior to the start of the study. For each participant,~     the total duration of the clinical trial will be between 3 to 8 weeks.~   "
30631|NCT03166098|"~     This is a single center study that uses both between-group comparisons and correlational~     analyses to establish biomarkers of dysmyelination and cognitive impairment in Psychotic~     Spectrum Disorders using imaging and neuropsychological assays.The study will provide~     non-invasive biomarkers of cognitive dysfunction in Psychotic Spectrum Disorder.~   "
30634|NCT03166059|"~     The CaveoVasc Thrombolysis Protection System is intended to aid sheath access and reduce~     bleeding complications during catheter directed thrombolysis (CDT) in the treatment of limb~     ischemia. This device has been designed to protect the puncture site by stabilizing the CDT~     sheath with the double-balloons that are part of the CaveoVasc system. Also the device is~     designed to reduce bleeding at the puncture site during CDT.~      This study is designed to assess the safety and performance of the CaveoVasc Thrombolysis~     Protection System in twenty patients with limb ischemia undergoing treatment with CDT.~   "
30635|NCT03166046|"~     Chronic pain is now widely understood to be due to central sensitization, which leads to~     exaggerated pain perception. Migraine is no exception, since it is well known that~     sensitization of the trigeminovascular pain pathway can occur during a migraine attach. There~     is early evidence that ActiPatch can help mitigate this sensitization, so this study is being~     conducted to determine the efficacy of ActiPatch in preventing chronic, episodic migraines.~   "
30636|NCT03166033|"~     This study is conducted to observe the characteristics of the risk factors of CTS in Chinese~     population.~   "
30637|NCT03166020|"~     The aim of this randomized controlled study with stroke patients is to demonstrate that a~     re-education with interactive table with instrumented objects delivering sensory feedback and~     serious game improve certain motor functions of the paretic upper limb than rehabilitation~     based on a standardized self-rehabilitation program.~   "
30638|NCT03166007|"~     The aim of the AMBER trial is to determine the effectiveness and cost effectiveness of~     abdominal massage as part of the adjunct to bowel care in people with Multiple Sclerosis who~     have problems with their bowel i.e. faecal incontinence and/or constipation.~   "
30639|NCT03165994|"~     This pilot phase II trial studies the side effects of CD40 agonistic monoclonal antibody~     APX005M (APX005M), chemotherapy, and radiation therapy, and to see how well they work when~     given before surgery in treating patients with esophageal cancer or gastroesophageal cancer~     that can be removed by surgery. APX005M is intended to stimulate the body's own immune system~     so that the immune cells can more effectively invade and destroy the tumor, adding to the~     benefits of the chemotherapy and radiation therapy. Drugs used in chemotherapy, such as~     carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either~     by killing the cells, by stopping them from dividing, or by stopping them from spreading.~     Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving~     APX005M, chemotherapy, and radiation therapy before surgery may make the tumor smaller and~     reduce the amount of normal tissue that needs to be removed.~   "
30640|NCT03165981|"~     A prospective, randomized open-label clinical trial that will be conducted during the~     2017-2018 influenza season. During the 2017-2018 season, approximately 280 children will be~     enrolled at Duke University Medical Center and Kaiser Permanente Northern California.~     Eligible children will be randomized to receive simultaneous or sequentially administered US~     licensed PCV13, US-licensed DTaP vaccine, and US-licensed inactivated influenza vaccine~     (IIV). Children in the simultaneous group will receive PCV13, DTaP, and IIV vaccines at Visit~     1, and then return for a health education visit without vaccination about 2 weeks later~     (Visit 2). Children in the sequential group will receive both PCV13 and DTaP without IIV at~     Visit 1, and then will receive IIV and health education about 2 weeks later (Visit 2).~     Parents will record the occurrence of fever, solicited adverse events, medical care~     utilization, and receipt of antipyretics over 8 days following Visit 1 and Visit 2. In~     addition, febrile seizures and serious adverse events will be recorded for the entire study~     period (from enrollment through 8 days following the Visit 2) as determined through parental~     report and chart review. Parental perceptions about their child's vaccine schedule will be~     assessed on the 8th day following Visit 2.~   "
30641|NCT03165968|"~     The long term goal for the Traumatic Injury Research Program (TIRP) is testing of novel~     devices for the identification and longitudinal assessment of traumatic brain injury (TBI).~     The Department of Defense (DoD) has now tasked TIRP with the test and evaluation of these~     devices to assess reliability and validity. The objective of this effort is to test the~     reliability of the NeuroKinetics Inc (NKI), i-PAS (portable assessment system) device using a~     test/re-test protocol with healthy controls.~      The basic research design adopted here is the test/re-test paradigm with three assessments~     obtained on three separate visits. This will allow the assessment of reliability of both the~     device and the measure(s) that are computed from the input signals. Participants will be~     Healthy Controls (HC) as defined in the inclusion exclusion section.~      In this initial study we will be administering standardized self-report instruments ( Short~     Form - 36 (SF-36) and the Symptom Checklist-90 (SCL-90r)), standard three-lead~     electrocardiogram. In addition we will administer the NKI i-PAS specific protocol as~     delineated by NKI.~   "
30642|NCT03165955|"~     This is a multicenter, open-label, single-arm PK study in patients for whom paclitaxel~     treatment is indicated.~   "
30643|NCT03165942|"~     This study proposes to examine both the peripheral and central nervous system responses when~     light social drinkers and binge/heavy social drinkers are exposed to intravenous infusion of~     ethanol. The findings will provide a greater understanding of the brain mechanisms (cerebral~     blood flow and functional connectivity) underlying the association between stress, cortisol~     release, heart rate variability, alcohol craving, and alcohol stimulant and sedative effects.~     This knowledge could be significant in developing new therapies for the treatment of~     alcoholism.~   "
30644|NCT03165929|"~     Connective tissue graft (CTG) and free gingival graft (FGG) harvesting from the palatal area~     has been used frequently in the periodontal mucogingival surgery and reported to provide~     higher predictability and success regarding esthetic outcomes. The aim of the study was to~     evaluate the effects of oral flurbiprofen spray on wound healing, postoperative patient~     morbidity and discomfort after palatal graft harvesting.~      Forty eight patients scheduled for CTG and FGG requiring periodontal plastic surgeries were~     selected. The patients were randomly assigned to each group, and used oral spray of~     flurbiprofen or placebo 3 times a day for a week. The palatal donor area was evaluated at 1~     and 3 days and 1, 2, 3, 4, 6 and 8 weeks postsurgery for postoperative pain, complete~     epithelization, feeding habits, color match, and total number of analgesic pills taken. The~     Wound-Healing Index (WHI) was recorded at 2-week follow up.~   "
41628|NCT03021850|"~     The purpose of this study is to compare the acute effect of the use of different thermal~     modalities associated to the training of passive flexibility of the hamstring muscles in the~     amplitude of motion of the knee extension.~   "
30646|NCT03165903|"~     The study tested an intervention that used a cue-removal and implementation intentions based~     strategy to change habitual dietary behaviors. The intervention was evaluated using a~     randomized experimental design that consisted of two conditions including (1) a control~     condition or (2) a cue and implementation intention-based intervention. High schools (N=22)~     were randomly assigned to one of the two conditions. Families (N=187), with a family defined~     as an adolescent and one participating parent, were recruited from within the 22 schools. All~     of the families from each school were assigned to the same condition.~      Families that were eligible for the study and that were interested in participating scheduled~     an appointment to complete informed consent. After written parental consent and youth assent~     was obtained, the participants had their height and weight measured and completed a series of~     questionnaires programmed on laptops. In addition, the adolescent took part in a 24 Hour~     Dietary Recall Assessment. The family was also informed that a second 24 Hour Dietary Recall~     Assessment would be administered to the adolescent over the phone in approximately 3-14 days.~      Families that were from a school assigned to the control condition received an intervention~     on sun safety that consisted of a 10-minute meeting with a trained Health Coach, two generic~     newsletters, an email, and a text message. Families from a school assigned to the cue- and~     implementation intentions condition received an intervention on healthy snacking and the~     reduction of sugar sweetened beverage consumption that consisted of a 90-minute meeting with~     a trained Health Coach, two 20-minute phone calls, four tailored newsletters, and a series of~     emails and text messages. Both of these interventions were delivered over a period of 3-10~     weeks depending on the self-directed pace of the participants. All participants were then~     asked to complete a follow-up assessment appointment three months after their original~     consenting appointment. Our hypotheses focused on dietary behaviors and stated that~     adolescents assigned to the cue-removal and implementation intentions intervention would~     consume significantly fewer daily servings of high fat snacks, high sugar snacks, and sugar~     sweetened beverages than adolescents in the control condition.~   "
30647|NCT03165890|"~     Randomized, placebo controlled trial evaluating the effect of acetazolamide on cognition in~     lowlanders with chronic obstructive pulmonary disease travelling from 760 m to 3200 m.~   "
30648|NCT03165877|"~     To compare the effect of low-glycemic index versus control lunches and dinners intake on~     indicators of satiety, metabolic parameters and liver steatosis degree on women with type 2~     diabetes under metformin therapy.~   "
30649|NCT03165864|"~     The purpose is to assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of~     IONIS TMPRSS6-Lrx Administered Subcutaneously for up to 44 Healthy Volunteers~   "
30650|NCT03165851|"~     The investigators adopted the CAMS（Chinese Academy of Medical Sciences）-2009 trial for~     pediatric acute myeloid leukemia (AML) patients between 2009 to 2015, in which a~     risk-stratified strategy and dose-dense intensive chemotherapy were introduced. The outcomes~     of CAMS-2009 trial were retrospectively analyzed, and compared to the CAMS-2005 trial.~   "
30651|NCT03165838|"~     Due to potential to improve family planning, clinicians are increasingly interested in~     shortening the time to postpartum visits, but lack an evidence base to change policy.There~     are no studies that have examined the effectiveness of shortened interval to postpartum visit~     on attendance rate, contraception use, and rapid repeat of pregnancy (RROP). With this~     research, the investigators propose to conduct a randomized controlled trial (RCT) to examine~     the effect of reduced time interval to postpartum visit (3-4 weeks rather than 6-8 weeks) on~     postpartum visit attendance rate, contraceptive use, and RROP.~   "
30652|NCT03165825|"~     compare cervical interlaminar epidural injection of betamethasone (9mg) and cervical~     transforaminal epidural injection of dexamethasone (15 mg) for cervical radicular pain~   "
30653|NCT03165812|"~     The incidence of diabetes mellitus is increasing annually in Asia. It is the leading cause of~     blindness, chronic renal insufficiency, and amputations, multiplying the risks of heart~     disease and stroke. Ninety percent of diabetic patients are type 2 diabetes mellitus (T2DM),~     which is usually associated with overweight and obese. Single Anastomosis Duodeno-Jejunal~     Bypass with Sleeve Gastrectomy (SADJB-SG) is a type of bariatric surgery whereby food is~     bypassed into the distal jejunum, and the duodenum is excluded. Sleeve gastrectomy offers the~     restrictive component by reducing the capacity of the stomach. In short, this combined~     technique results in food restriction and malabsorption. A total of 84 patients will be~     recruited in this study. An equal number of patients will be allocated into two groups. There~     will be an intensive medical therapy group (IMT) and SADJB-SG group. The patients in IMT~     group will be subjected to strict adherence to diet, optimization of diabetic medications and~     close monitoring of blood glucose and glycated haemoglobin (HbA1c) level. The SADJB-SG group~     will be undergoing surgery. The variables that will be studied include body mass index (BMI),~     fasting blood glucose (FBG), glycated haemoglobin (HbA1c), C- peptide, plasma insulin and~     Homeostatic Model Assessment of Insulin Resistance (HOMA-IR). Biochemical markers are~     important in this research as the development of T2DM involves both multi-organ insulin~     resistance and inadequate insulin secretion by pancreatic β-cells, leading to high blood~     sugar during fasting and post meal. Other mechanisms proposed in this study are leptin,~     adipokines, incretins, amino acids, and diabetic dyslipidaemia. The raw data will be analysed~     using the SPSS statistical software. At the end of the study, the investigator will evaluate~     and determine the role of SADJB-SG in glycaemic control and BMI in T2DM patients compared to~     IMT. The investigator hypothesized that there is an improvement in HbA1c level in T2DM~     patients in SADJB-SG group compare to IMT group.~   "
30654|NCT03165799|"~     This is a single center, randomized study that assessed the effects of mindfulness training~     on physician teaching teams at a VA hospital.~   "
30655|NCT03165786|"~     This study is being conducted to determine the feasibility of a cognitive behavioral therapy~     intervention to reduce fear of hypoglycemia and improve glucose levels in young adults with~     type 1 diabetes.~   "
30656|NCT03165773|"~     The objectives of this study are to assess the 4 hr postprandial kinetics of total and~     exogenous glucose in response to consumption of oatmeal containing a high percentage of the~     viscous agent β-glucan, in comparison to a β-glucan free corn cereal that is matched by grams~     of available carbohydrate.~   "
30657|NCT03165760|"~     Randomized controlled trial, comparing two groups of 40 patients each scheduled for open~     major abdominal surgery. The intervention group was ventilated with a protective strategy~     consisting on a low Tidal volume (Vt) (6ml/kg of predicted body weight (PBW)), positive end~     expiratory pressure (PEEP) = 10 cm H2O and recruitment manoeuvres (RM) after disconnection~     from the ventilator, the control group had classic ventilation (Vt = 8 ml/kg of PBW, PEEP = 4~     cmH2O and no RM).~   "
30658|NCT03165747|"~     Osteoporosis has a devastating impact on quality of life of postmenopausal women, and is a~     significant cause of disability and morbidity. Many drugs are approved for the prevention and~     treatment of osteoporosis, but are associated with high costs and side effects. Some data~     from animal studies suggests that supplementation with probiotics can safely treat and~     prevent osteoporosis. The probiotic VSL#3 is commercially available, is safe for human~     consumption, and has been widely used in human clinical trials, and has known~     health-promoting effects in both children and adults.~      The double-blind, randomized, placebo-controlled trial of VSL#3 will be conducted for 12~     months in 40 postmenopausal women to determine if VSL#3 improves bone mineral density and~     related bone markers. Study visits will include all or some of the following procedures: a~     medical exam, urine collection, height and weight measurement, a blood draw to assess bone~     biomarkers, a DEXA (dual energy X-ray absorptiometry) scan to measure bone density, and~     health questionnaires.~      This is one of the first clinical trials proposed to investigate the effects of probiotics in~     bone in humans. If successful, this proposal will provide the first evidence that nutritional~     supplementation with the probiotic VSL#3 is a safe and effective strategy for preventing~     postmenopausal bone loss.~   "
30659|NCT03165734|"~     This is a Bayesian adaptive dose-finding study in patients with primary or secondary~     myelofibrosis:~        1. who have failed therapy with ruxolitinib on the basis of intolerance or loss of~          efficacy,~        2. highly symptomatic (DIPSS risk score of Intermediate-1, Intermediate-2 or High Risk, and~          MPN-SAF TSS 2.0 of ≥10),~        3. and have splenomegaly (assessed by physical examination).~      Condition or disease: Primary Myelofibrosis/Post-Polycythemia Vera Myelofibrosis/~     Post-essential Thrombocythemia Myelofibrosis~      Intervention/treatment: Drug-Pacritinib~      Phase: Phase 2~   "
30660|NCT03165721|"~     Background:~      Wild-type gastrointestinal stromal tumor (GIST) is a cancer in the esophagus, stomach, or~     intestines. It does not respond well to standard chemotherapy or radiation therapy. Most~     people with GIST are treated with imatinib. But it may not work in many children with GIST.~     Researchers think the drug SGI-110 may help treat people with GIST, pheochromocytoma and~     paraganglioma (PHEO/PGL), or kidney cancer related to hereditary leiomyomatosis and renal~     cell carcinoma (HLRCC).~      Objective:~      To learn if SGI-110 causes GIST tumors to shrink or slows their growth. Also to test how it~     acts in the body.~      Eligibility:~      People ages 12 and older who have GIST, PHEO/PGL, or HLRCC that has not responded to other~     treatments~      Design:~      Participants will be screened with:~        -  Physical exam~        -  Urine tests~        -  CT or MRI, or FDG-PET scan: A machine takes pictures of the body.~        -  Blood tests~      Participants will be injected with SGI-110 under the skin each day for 5 days. This cycle~     will repeat every 28 days. The cycles repeat until their side effects get too bad or their~     cancer gets worse.~      Participants will have tests throughout study:~        -  Physical exam and blood and urine tests before each cycle~        -  Blood tests on days 1, 7, 14, and 28 of the first cycle.~        -  Scans before cycle 1 and then every other cycle.~        -  Questionnaires about their pain and quality of life~        -  Tumor biopsy for those 18 and older: A needle removes a small piece of tumor.~      After they stop treatment, participants will have a final visit. This includes an evaluation~     of their health, pain, and quality of life.~   "
30661|NCT03165708|"~     The purpose of this study will be to evaluate the inter-rater agreement, or concordance,~     between an expert anaesthesiologist and the CompuFlo® Epidural Computer Controlled System for~     the epidural space verification.~      Primary study endpoint will be successful concordance of identification of ligamentum flavum~     and epidural space during a standard epidural procedure in pregnant patient. Secondary~     outcome will be successful concordance of identification of bony contact during a standard~     epidural procedure in pregnant patient.~   "
30662|NCT03165695|"~     This study evaluates whether Ramelteon can prevent delirium, decrease the severity of~     incident delirium and improve sleep wake cycle in hospitalized elderly surgical patients.~     Half of the patients will be assigned to Ramelteon, while other half will be assigned to~     placebo.~   "
30663|NCT03165682|"~     Systemic lupus erythematosus is a chronic inflammatory autoimmune disease with an unknown~     cause and many challenges. Whilst corticosteroids and effective immunosuppressive therapy~     have transformed the management of patients with active systemic lupus erythematosus, one of~     the major causes of morbidity in Systemic lupus erythematosus patients is chronic,~     debilitating fatigue.~      Despite frequent occurrence of fatigue in Systemic Lupus Erythematosus, to the best of our~     knowledge, no studies have been directly performed to examine fatigue-related changes in~     cortical motor function in Systemic lupus erythematosus. In this study, we hypothesized that~     Systemic lupus erythematosus patients with fatigue and depression versus Systemic lupus~     erythematosus patients without fatigue and depression would present an alteration of motor~     cortex excitability.~   "
30664|NCT03165669|"~     This randomized controlled with cross-over trial aims to investigate the efficacy of a~     cervical pillow (the Viscospring PostuRite made by SOFF-ART S.r.l. Via Maestri del Lavoro~     49 - 05100 Terni, Italy) versus education in non-specific chronic neck pain. More~     specifically, effectiveness will be measured using the following outcome measures: pain,~     disability, sleep quality, cervical pillow satisfaction, and global perception of the~     treatment effectiveness.~   "
30665|NCT03165656|"~     The purpose of the current study is to evaluate the progression of right ventricular function~     and dimension in Kyrgyz highlanders with high altitude pulmonary hypertension (HAPH) by~     performing a cross sectional case-control study.~   "
30666|NCT03165643|"~     Background Macrosomia at birth is associated with subsequent susceptibility to obesity,~     abnormal glucose metabolism, hypertension and dyslipidaemia. Epigenetic reprogramming has~     been reported to be involved in the development of human diseases caused by suboptimal~     environmental or nutritional factors.~      Objective The study was aiming to explore epigenetic mechanism influences on macrosomic~     infants exposed to intrauterine hyperglycemia.~      Design The investigators performed a genome-wide analysis of DNA methylation in cord blood~     from macrosomic infants born to women with gestational diabetes or infants with normal birth~     weight born to normal glucose-tolerant women in order to identify genes related to foetal~     growth or early adipose tissue development. The candidate genes were then validated using~     SEQUENOM MassARRAY after bisulfite conversion.~   "
30667|NCT03165630|"~     Background: Stroke is the leading cause of long-term disability in Singapore, and studies~     have found that intensive specialized stroke rehabilitation can improve post-stroke~     functional outcomes for a substantial proportion of stroke patients. However, despite the~     benefits associated with adherence to prescribed rehabilitation, the uptake rate of~     outpatient rehabilitation services (ORS) in Singapore is only 33%.~      According to local longitudinal studies, the financial burden of out-of-pocket service costs~     and the inconvenient transportation from home to rehabilitation centres are important~     barriers to access to ORS.~      Objective: To examine the effect and cost-effectiveness of providing incentives for ORS to~     improve the uptake of ORS compared to usual care (control) with no incentives~      Hypothesis: An evidence-based program to test the effectiveness of providing incentives to~     alleviate the financial burden as well as inconvenience of transportation for ORS will~     improve the uptake of and adherence to ORS among stroke patients.~      Methodology: This study is an individual-based randomized controlled trial (RCT) of 300~     stroke patients recruited from Singapore General Hospital (SGH) and Changi General Hospital~     (CGH). They will be randomized to one of three study arms (education only, free~     transportation, and free services and transportation) and interviewed at the time of~     recruitment and four months after the enrolment in the study. Participants' health~     conditions, socioeconomic situation, health & medical services utilization, stroke-related~     disability measures, quality of life, and reasons for uptake/rejection/withdraw from the~     services will be collected during both baseline and the 4th month assessments.~      Significance: As the first study in Singapore to test innovative ways to increase the stroke~     ORS uptake rates, it will provide evidence for future policy changes in financing outpatient~     rehabilitation and other long-term care services in Singapore. It will also provide important~     empirical parameter estimates for Systems Dynamics modelling of the demand and supply of ORS~     in Singapore.~   "
30668|NCT03165617|"~     The randomized, observer-blind non-influenza comparator controlled study is intended to~     demonstrate the efficacy, immunogenicity, safety and tolerability of Seqirus' cell-based~     inactivated quadrivalent vaccine (QIVc) in subjects ≥2 years to <18 years of age~   "
30670|NCT03165591|"~     Pancreatic cancer (PDA) is the most lethal form of cancer, and the fourth-leading cause of~     cancer-related death in the United States, with a survival rate of less than 7%.There are~     currently no treatments found to be effective for patients with advanced disease who are~     ineligible for surgery, a prognosis representing the majority of pancreatic cancer diagnoses.~     Pancreatic cancer is not amenable to chemotherapy as compared to other cancer types, leaving~     patients with practically no options except surgery.~      We have made oral tableted therapeutic vaccine, V3-P, derived from pooled blood of patients~     with PDA in line with similar highly promising approach we have adopted for patients with~     hepatocellular carcinoma (HCC) and cholangiocarcinoma (CAA). Patients with PDA will be given~     one tablet per day of V3-P and followed up to see the outcome.~   "
30671|NCT03165578|"~     The objective of the present study is to identify brain networks in patients that contribute~     to successfully learning self-regulation with real-time fMRI.~   "
30672|NCT03165565|"~     The purpose of this pilot study is to assess whether the hospital-based, adaptive behavioral~     intervention strategy promotes treatment entry and reduces risk of additional~     substance-exposed pregnancies (SEPs), as well as HIV and HCV risks among substance-using NICU~     mothers. Additionally, to assess whether the intervention increases use of professional~     obstetrical/gynecological resources for contraception to reduce substance-exposed pregnancies~     (SEPs).~   "
30673|NCT03165552|"~     Patients with abnormal kidney function are common in primary care, particularly in people~     with other long standing illnesses. Some of these patients have long standing weakness of~     their kidneys, others develop new kidney weakness alongside other new illnesses. Patients~     with weak kidneys are more likely to be admitted to hospital, spend longer in hospital or die~     than those with normal kidneys. Although these events are common, how kidney weakness~     develops in the community is not well understood and awareness is poor. It is known that~     appropriate attention to a patient's medical care at times of high risk may reduce the onset~     of new kidney weakness. We have developed a new education package for primary healthcare~     professionals and patients. This will teach them about risks of new kidney weakness in their~     patients, give advice about how to combat them, and help prevent it occurring. This project~     will also use a new software tool - IMPAKT EVOLVE-AKI - to extract information from primary~     care systems and combine this with hospital data to identify developing kidney weakness much~     more accurately primary care . Both these elements of the study have already been tested in~     primary care and we are confident that they work well. Patients and the public have been~     involved in the development of these tools and will also be closely involved in their~     implementation. We now intend to implement the education more widely in primary care. We will~     then test how effectively the education has been implemented and whether it has a significant~     effect on the number of episodes of new kidney weakness developing in primary care. We~     calculate that we will need to provide this education to 36 practices to be able to determine~     accurately whether the programme significantly reduces new kidney weakness. Advice we have~     received from colleagues in primary care indicates that they are very interested in this~     education programme, and we believe that that a positive result from this study will lead to~     rapid and wide implementation of this combined programme of education and data analysis to~     the benefit of patients across the UK. This study fits well with a national programme of work~     in this area, and this combination will help with wider adoption of the study findings when~     the results are available.~   "
30674|NCT03165539|"~     This study will assess the incidence and risk factors for post-operative delirium in patients~     undergoing thoracotomy. Specifically, the study will assess if there is any relationship~     between an intra-operative decrease in brain oxygen levels which can occur during one-lung~     ventilation, and the occurrence of delirium in the post-operative period.~   "
30675|NCT03165526|"~     FDA issued a Humanitarian Device Exemption (HDE) approval order for the AMPLATZER™ PIVSD~     Occluder (H070005) on January 10, 2017. The Conditions of Approval require that SJM conduct a~     post approval study to evaluate the safety and probable benefit of the AMPLATZER™ PIVSD~     Occluder.~   "
30676|NCT03165513|"~     The project aimed to create a dialogue between the informal sector (traditional and faith~     healers) and the formal sector (trained health care workers) in order to increase synergy and~     communication between the two systems, by minimizing any harmful practices and enhancing~     complementary practices. The informal sector will also be trained on how to use WHO mhGAP-IG~     component on depression for routine screening in order to ameliorate functional and social~     outcomes and refer complicated cases to the formal sector for biological interventions~   "
30677|NCT03165500|"~     The surgery for the extraction of the third molars is a procedure in Dentistry that generates~     a large picture of anxiety in the patient. One of the ways to try to soften this picture, are~     the professionals to use sedation. Thus, the objective of this study was to evaluate three~     sedation protocols, and to compare them with vital signs values, in order to obtain the~     sedation method with greater patients stability.~   "
30678|NCT03165487|"~     The goal of the project is to identify a molecular signature of tumor stroma from normal~     adjacent breast tissue obtained prospectively at the time of breast conserving surgery before~     and after receiving intraoperative radiation therapy (IORT) in subjects that have luminal A~     and triple negative breast cancer. IORT is considered as being standard of care.~   "
30679|NCT03165474|"~     The primary purpose of this study is to assess the feasibility and participant acceptability~     of an interactive, internet/mobile-enabled dietary self management intervention. The~     secondary purpose of this study is to determine if the intervention improves knowledge,~     attitudes and food preferences associated with the targeted behaviors, to reduce childhood~     obesity risk from baseline to post-test.~   "
30680|NCT03165461|"~     Failed intubation is currently one of the most important factors leading to morbidity and~     mortality in anesthesia.~      The development of supraglottic airway devices (SGDs), such as the intubating laryngeal tube,~     has revolutionized airway management, as these devices allow adequate ventilation and~     oxygenation in situations where ventilation and/or intubation via conventional means pose a~     challenge. Several publications describe the usefulness of such devices for salvaging~     ventilation in patients that cannot be intubated with direct laryngoscopy or who cannot be~     ventilated with a facemask. In these salvage situations, SGDs are highly effective in~     achieving adequate patient oxygenation.~      Achieving effective oxygenation with an SGD and completely isolating the airway by intubation~     at the same time. This is now possible thanks to the so called supraglottic intubation~     devices (SGIDs). For that reason, we believe it is necessary to conduct a study that allows~     evaluation of the performance of this device in the context of daily clinical practice.~      Its design characteristics, its capacity to be used in intubation applications, its soft and~     atraumatic materials as well as its disposability augur this product a significant expansion~     in the next few years. Nonetheless, no data are available on the success of intubation when~     the intubating laryngeal tube suction device (ILTSD) is used. The idea behind this study is~     to assess the possibilities to use the ITLSD device to intubate patients in regular~     anesthetic practice.~   "
31229|NCT03158298|"~     The study intends to examine the association between schistosomiasis seropositivity and~     adverse pregnancy outcomes.~      It aims at the verification of the hypothesis that in pregnant women originating from endemic~     areas for schistosomiasis, positive serology is associated with reduced Infant birth weight.~   "
30681|NCT03165448|"~     Patient's psycho-emotional status is being affected during various dental procedures causing~     patient's and doctor's discomfort. There are three basic factors, composing psycho-emotional~     status: fear, stress and pain sensitivity. There aren't any objective method that may help in~     standard evaluation of oral surgery patient's psycho-emotional status. In the present~     non-standardized evaluation, there is a problem of heterogeneity between studies, and also~     ineffective patient's evaluation. Therefore, Universal Scale in oral surgery for patient's~     psycho-emotional status rating (USOS) was designed. Clinical trial to validate the USOS was~     constructed.~   "
30682|NCT03165435|"~     Study CV-0003 will be the second clinical trial administering CV-MG01 in humans. This will be~     a phase 2/3 proof-of-efficacy therapeutic confirmatory study following the proof-of-concept~     exploratory phase 1 study (CV-0002).~   "
30683|NCT03165422|"~     This is a medical chart review of ipilimumab treatment after nivolumab treatment in melanoma~     in Japan~   "
30684|NCT03165409|"~     This study is a real-world retrospective claims analysis to assess and compare AE-related~     HCRU and medical costs among patients with different follow-up frequency after initiating a~     melanoma therapy.~   "
30685|NCT03165396|"~     According to the inclusion and exclusion criteria, elderly patients undergoing elective~     orthopedic surgery were randomly divided into four groups. The different combinations of~     propofol and sevoflurane were used in the four groups: 1 day before surgery, after patients~     become wide-awake, and 3 days, 7 days, and 3 months after surgery, the patient's cognitive~     function was evaluated using a professional cognitive scale and other indicators. Finally,~     statistical analysis.~   "
30686|NCT03165383|"~     Effective postoperative pain control results in decreased cardiac and pulmonary~     complications, patient satisfaction and early mobilization. A prospective, randomized~     comparative study was done of analgesic efficacy, opioid requirement and side effects in~     patients undergoing lower abdominal cancer surgeries. In Study Group Ultrasound guided~     Transversus Abdominis Plane (TAP) block was given and control Group no TAP block was given.~     Patient controlled analgesia (PCA) with intravenous morphine was given to both group~     patients, and total good PCA demands in both the groups was studied.~   "
30687|NCT03165370|"~     Insomnia is one of the most main diseases of civilization in the world, which chronic~     insomnia is up to 30% in Taiwan under the latest statistics and a common disease which~     appears to sleep difficultly, sleep interrupted, wake up early or wake up still tired.~     Long-term persistence of these symptoms will lead to the occurrence of mental illness and~     then affect people's emotional behavior and cognitive memory, showing that insomnia is an~     important modern health issues. Recently, individual response patterns was proposed by~     modern medicine. This thinking process and spirit seems to be compatible with the traditional~     Chinese medicine (TCM) therapy of Differential Treatment. The purpose of this study, the~     Athens Insomnia Scale (AIS), commonly used to quickly screen for insomnia patients and the~     evaluation of Western medicine efficacy in Western medicine clinic, and investigation of~     Syndrome Type of TCM to find out whether with Syndrome Type of TCM and AIS in the associated~     factors, and confirm the necessity and importance of Syndrome Type of TCM, for future~     reference and basis for the development of integrated medicine.~      In the cross-section study with an interview on survey, sampling Miaoli County an Chinese~     medicine clinic, in line with standard sampling of 200 patients with insomnia were recruited.~     The questionnaires contained two instruments including Athens Insomnia Scale (AIS), and~     Syndrome Type of TCM questionnaire. Cross-table, chi-square test, variance analysis and~     Pearson product-moment correlation was used to find the relation.~   "
30688|NCT03165357|"~     The purpose of this study was to verify the effect of 10-day sodium bicarbonate (NaHCO3) and~     placebo (PLA) supplementation on body composition, physical capacity, as well as~     concentrations of the selected biochemical blood markers in trained athletes, in a~     randomised, double-blind, placebo-controlled crossover trial.~   "
30689|NCT03165344|"~     Endoscopic submucosal dissection as the fastest growing endoscopic treatment technology in~     the past decade has been widely used in the treatment of early esophageal cancer and gastric~     cancer without local lymph node metastasis. The main complications of ESD treatment of early~     esophageal cancer are hemorrhage, perforation, postoperative esophageal stenosis, infection,~     etc. Postoperative esophageal stenosis is the most common and major complication after ESD~     treating patients with lesion involving more than 2/3 esophagus cycle. It is very important~     to prevent esophageal stricture after ESD. Glucocorticoid is gradually concerned by clinical~     research because it can inhibit local inflammatory response and reduce the formation of~     connective tissue in order to prevent postoperative stenosis. The specific usages include~     endoscopic injection of corticosteroids, oral corticosteroids and combination of them. The~     study shows that the incidence of esophageal stricture after using glucocorticoid can be~     reduced effectively. Currently, there is no uniform consensus on the use of glucocorticoids,~     such as specific drugs, dosage, course of treatment, route of administration. In particular,~     efficacy comparison of different routes of administration is laking. Studies have shown that~     endoscopic injection triamcinolone acetonide in some patients with intractable esophageal~     stricture is not very effective, but it can be treated with oral corticosteroids. Aluminium~     Phosphate Gel is a kind of neutral buffer. The main component aluminum phosphate can form a~     strong ion buffer system in acidic environment. The structure of its auxiliary components~     agar and pectin is similar to that of natural mucus. It forms a mucous layer in the esophagus~     to restore and protect the esophageal mucosa. Therefore, investigators assume the~     hydrocortisone sodium succinate aluminum phosphate mixed gel can be used for preventing~     postoperative ESD stenosis of patients with a large area of early esophageal cancer. This~     study will design a randomized controlled trial to compare the effect of oral hydrocortisone~     sodium succinate mixed Aluminium Phosphate Gel and local injection of triamcinolone acetonide~     plus oral prednisone for the prevention of ESD postoperative esophageal stricture in patients~     with a large area of early esophageal cancer.~   "
30690|NCT03165331|"~     A visible difference can have a profound impact in a society with a massive emphasis on~     appearance and looks. A vulnerable group is adolescents with a condition affecting their~     appearance as a result of injuries (burns, accidents), treatment (cancer), skin conditions or~     congenital anomalies (birthmarks, craniofacial conditions). Research has identified potential~     psychological difficulties, which, if not addressed, can lead to anxiety, depression, and~     eating disorders.~      In addition to medical treatment options, aiming at diminishing a difference that may be~     visible to others, young people with appearance concerns also need self-management skills.~     However, evidence-based interventions are scarce and specialised psychological treatment is~     difficult to reach.~      The Centre for Appearance Research (Bristol, UK) has developed an online intervention for~     adolescents, now translated into Norwegian (www.ungfaceit.no). UNG Face IT provides easy~     access to specialist advice and support via a home computer, using information, videos, and~     interactive activities. It provides advice, teaches coping and social skills, strengthening~     psychological adjustment to a visible difference.~      A systematic evaluation of the Norwegian version is needed. UNG Face IT could potentially~     address unmet needs, provide a cost-effective tool to reduce the need for face-to-face~     psychological and surgical/medical services, and contribute to make online health care~     available for young people with a visible difference.~   "
30693|NCT03165292|"~     The main objective is to evaluate the efficacy of two intensified consolidation strategies in~     very-high risk neuroblastoma (VHR-NBL) patients in terms of event-free survival from~     randomisation date. This evaluation will follow a hierarchical testing procedure: each~     experimental treatment will be first evaluated as a single-arm phase 2 study, and in case of~     positive conclusion, the relative efficacy of both arms will then be evaluated comparatively.~   "
30694|NCT03165279|"~     To prospectively collect 'real world' performance data on the Zenith AlphaTM Abdominal~     Endovascular Graft for endovascular aneurysm repair, inside and outside instructions for use.~     To assess clinical efficacy of the low-profile device to treat patients with abdominal aortic~     aneurysm (AAA), to assess the use of the new delivery and deployment system of the Zenith~     AlphaTM Abdominal Endovascular Graft. Primary endpoint is the proportion of subjects who~     experience successful treatment at 1 year post-implant; defined by technical success and~     clinical success.~   "
30695|NCT03165266|"~     Right ventricular infarction usually occurs in association with inferior myocardial~     infarction in about 10-50% of the cases. Currently the presence of elevation in right~     pericordial leads is the most powerful indicator of right ventricular infarction.~      The incidence of right ventricular infarction is more in postmortem studies,meaning that~     Right ventricular infarction is underestimated, possible explanation for this difference~     could be explained that electrocardiographic sign of Right ventricular infarction disappear~     early or patients presented late.~   "
30696|NCT03165253|"~     The aim of the study is to evaluate the effects of the synbiotic Bifidobacterium animalis~     ssp. lactis B94 plus inulin addition to the standard triple therapy on Helicobacter pylori~     infection eradication rates in children.~   "
30697|NCT03165240|"~     The primary objective of this current trial is to investigate the safety and tolerability of~     4 oral doses of BI 690517 over 28 days in female and male patients with diabetic nephropathy~     as add-on-therapy to Angiotensin Converting Enzyme inhibitor [ACEi] or Angiotensin-receptor~     blockers [ARB].~      Secondary objective is to evaluate the change from baseline in Urine Albumin-to-Creatinine~     Ratio [UACR].~   "
30698|NCT03165227|"~     The main objective of this trial is the safety and tolerability of 4 multiple rising oral~     doses of BI 685509 over 28 days in male and female patients with Diabetic Nephropathy (DN) as~     adjunctive to Angiotensin Converting Enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker~     (ARB). Another objective is the change in Urine Albumin Creatinine Ratio (UACR), an important~     diagnostic marker of nephropathy.~   "
30699|NCT03165214|"~     Chronic pelvic pain is defined as chronic or persistent pain perceived in structures related~     to the pelvis of either men or women for more than 6 months according to The International~     Association for the Study of Pain. In other words, chronic pelvic pain with associated~     ovarian vein varicosities is termed pelvic congestion syndrome and is an important but~     under-diagnosed condition~   "
30700|NCT03165201|"~     This will be a prospective, multi-centre, biomarker trial comparing the accuracy of a new~     test (LiverMultiScan) against an existing test (liver biopsy) in the assessment of liver~     transplant recipients, designed in accordance with the STARD criteria.~      Study participants are 200 patients with liver transplant, due to undergo liver biopsy as~     part of serial evaluation of their liver health and to rule out rejection. The whole study~     will take 3 years with 2 years of recruitment The main aim is to investigate whether the~     introduction of LiverMultiScan as a standardised diagnostic test for liver disease can match~     the diagnostic yield of existing biopsies.~   "
30701|NCT03165188|"~     This protocol (NLG0705) provides a mechanism for the 15-year follow-up period that the FDA~     requires for all participants in gene transfer protocols and assures that adequate follow-up~     can be maintained for subjects who have received at least one dose of algenpantucel-L.~   "
30702|NCT03165175|"~     The aims of this pilot study are: (1) to assess the feasibility and acceptability of a mobile~     application to educate military members about the risks of prescription drug misuse; (2) to~     determine if there is evidence that the mobile application plus treatment as usual reduces~     the risk of prescription drug misuse and shows differences in related measures compared to~     treatment as usual among military medical clinic patients currently taking prescription~     medication; and (3) if evidence of reduced risk is found, to estimate effect sizes for a~     future effectiveness trial. The pilot study will use a randomized controlled design with two~     groups. The control group will be provided with treatment as usual (TAU), and the~     experimental group will be provided with the MedAware smartphone application in addition to~     treatment as usual (app + TAU). Self-reported measures of risk of misuse and related~     attitudes and knowledge will be administered to all participants at baseline, 1 month, and 3~     months. The mobile app is a brief intervention designed to help military members to assess~     their risk for medication misuse and provide individualized feedback on risk level with~     recommendations for reducing risk. The app also contains other features, including sections~     in which to store information on current medications and look up drug interactions and~     provides resources for help.~   "
30703|NCT03165162|"~     The purpose of this project is to gain a better understanding of the underlying consumer~     motivations associated with choosing foods labeled as natural; and further, how the use of~     this term impacts the amount of food consumed.~   "
30704|NCT03165149|"~     The aim of this study is to investigate the effect of addition of different doses of Ketamine~     locally in acute and chronic post-mastectomy pain after breast cancer surgery and on the~     probability of developing chronic post-mastectomy pain.~   "
30720|NCT03164941|"~     Selective Laser Trabeculoplasty (SLT) is a glaucoma treatment that has been shown to~     effectively lower intraocular pressure by increasing aqueous outflow through macrophage~     recruitment. There is evidence of increased drainage in the nasal quadrants of the eye. This~     study aims to compare whether there is a difference in the reduction of eye pressure when SLT~     is performed nasally and temporally.~   "
30721|NCT03164928|"~     To evaluate the effect of denosumab on lumbar spine bone mineral density (BMD) Z-score as~     assessed by dual-energy X-ray absorptiometry (DXA) at 12 months in children 5 to 17 year of~     age with Glucocorticoid (GC)-induced osteoporosis (GiOP).~   "
30800|NCT03163901|"~     Test the hypothesis that a certain set of osteopathic manipulation procedures preformed on~     patients with mild to moderate traumatic brain injury will result in accelerated rates of~     recovery assessed using vestibular function tests, quality of life questionnaires and~     measurements of the levels of anti-inflammatory metabolite and protein biomarkers in the~     blood and urine.~   "
30705|NCT03165136|"~     Recurrent miscarriage (RM) defined by >=3 consecutive losses affects 1% of fertile couples.~     Most women have recurrent early loss with a failure of development before 10 weeks'~     gestation. Standard investigations fail to reveal any apparent cause in >50% of couples.~      No study has demonstrated any benefit of any medication in women with Unexplained RM, in the~     presence or absence of an inherited thrombophilia.~      Moreover, the benefit of aspirin and/or heparin has not been proved in women with~     Antiphospholipid (APL) antibody without other clinical manifestations of Antiphospholipid~     Syndrome.~      Hydroxychloroquine (HQ) is a molecule whose properties (anti-thrombotic, vascular-protective,~     immunomodulatory, improved glucose tolerance, lipid-lowering, anti-infectious) could be~     useful against mechanisms of Unexplained RM.~      There is no data concerning the benefit of HQ in RM in the presence or absence of~     antiphospholipid antibodies or any inherited thrombophilia.~      Administration in (Systemic Lupus erythematosus (SLE) women and for Malaria prevention~     provides extensive safety data during pregnancy.~      Oral administration makes possible treatment since the preconception period. For all of that~     and its low cost, hydroxychloroquine should be evaluated in RM whatever the woman~     thrombophilic status.~   "
30706|NCT03165123|"~     Postoperative nausea and vomiting is defined as any nausea, retching, or vomiting occurring~     during the first 24-48 h after surgery in inpatients. Postoperative nausea and vomiting is~     one of the most common causes of patient dissatisfaction after anesthesia, with reported~     incidences of 30% in all post-surgical patients and up to 80% in high-risk patients. In~     addition, postoperative nausea and vomiting is regularly rated in preoperative surveys, as~     the anesthesia outcome the patient would most like to avoid. While suture dehiscence,~     aspiration of gastric contents, esophageal rupture, and other serious complications~     associated with postoperative nausea and vomiting are rare, nausea and vomiting is still an~     unpleasant and all-too-common postoperative morbidity that can delay patient discharge from~     the post-anesthesia care unit and increase unanticipated hospital admissions in outpatients.~   "
30707|NCT03165110|"~     The purpose of this study is to assess the utility of the Contour Diabetes App 2.0 when used~     with the Contour Next One meter (the Onyx system).~   "
30708|NCT03165097|"~     The primary purpose of this study is to evaluate the safety and tolerability of ascending~     multiple doses of ACT-709478 in healthy male and female subjects~   "
30709|NCT03165084|"~     The aim of this study is to develop and evaluate a person-centred digital intervention in~     primary healthcare for people with T2D, in addition to their usual diabetes care.~   "
30710|NCT03165071|"~     The primary purpose of this study is to investigate the fate of ACT-132577 in healthy~     subjects and in people with severe kidney disease~   "
30711|NCT03165058|"~     In this study, the investigators propose to use mucosal impedance (MI), a minimally invasive~     technology, to detect mucosal damage (i.e. barrier dysfunction) based on mucosal conductivity~     changes in the colonic epithelium.~   "
30712|NCT03165045|"~     The objective of this NIS is to measure changes in health status including functional status~     using CCQ scores in COPD patients receiving treatment with Spiolto® Respimat® according to~     label after approximately 6 weeks in routine clinical practice.~   "
30713|NCT03165032|"~     The purpose of the current study is to evaluate the right ventricular function during graded~     cycling on an ergometer by transthoracic echocardiography in Kyrgyz highlanders with high~     altitude pulmonary hypertension (HAPH) by performing a cross-sectional case-control study.~   "
30714|NCT03165019|"~     The purpose of the current study is to evaluate the clinical and physiologic course of Kyrgyz~     highlanders with high altitude pulmonary hypertension (HAPH) by performing a longitudinal~     cohort study. To this end, the investigators will invite the same highlanders who~     participated in the study in 2012 to undergo follow-up examinations in 2017, in order to~     allow comparisons of current results with baseline data from 2012.~   "
30715|NCT03165006|"~     This is a multicenter retrospective cohort of women participating in breast cancer screening~     programs in Spain between 2000 and 2009, with a cancer diagnosed during the screening or~     between the screening interval (interval cancer), specifically true interval cancers and~     false negatives. The investigators obtained woman-related information (including breast~     density), tumor-related information (including tumor phenotype), and follow-up information~     (including relapses, second neoplasms and vital status at the end of follow up (June 2014)).~     The objective is to evaluate the survival and disease-free period of women participating in~     screening programs for breast cancer with a cancer diagnosed during the screening or an~     interval cancer, specifically true interval cancers and false negatives.~      This study is part of a broader project (CAMISS study), which also includes one prospective~     cohort (CAMISS Prospective cohort - Identifier in ClinicalTrials.gov: NCT02439554).~   "
30716|NCT03164993|"~     This is a randomized, double-blind, placebo-controlled phase II study evaluating the safety~     and efficacy of Atezolizumab when combined with immunogenic chemotherapy in subjects with~     metastatic triple-negative breast cancer. Atezolizumab, pegylated liposomal doxorubicin and~     cyclophosphamide are the Investigational Medicinal Products (IMPs).~   "
30717|NCT03164980|"~     This is a multicenter, randomized, controlled, open-label study including patients with~     recurrent, platinum-sensitive, ovarian, peritoneal or fallopian tube cancer.~      The main scope of the trial is to evaluate QoL during chemotherapy comparing trabectedin/PLD~     with other standard platinum-based chemotherapy in platinum-sensitive disease.~   "
30718|NCT03164967|"~     This study is part of the BIVIGAM® post marketing requirement (PMR). It is being conducted in~     subjects aged 2-16 with primary immune deficiency disorders associated with defects in~     humoral immunity to generate additional data on these populations, and more specifically~     safety and pharmacokinetic (PK) assessments.~   "
30719|NCT03164954|"~     Following surgery, some but not all patients develop persistent (or chronic) postoperative~     pain CPSP. Several risk factors for this persistent pain have been confirmed in previous~     studies, but neither surgeons nor anesthesiologists have or take the time to systematically~     screen patients for this risk. However, hospital information systems often contain the data~     already, entered during preoperative consultations (e.g. chronic opioid medication) or~     obtained during the postoperative period (e.g. pain scores).~      Here the investigators test an automatic detection algorithm which alerts the analgesia team~     when a patient at risk of CPSP is or has been operated.~   "
30722|NCT03164915|"~     The main purpose of this study is to assess the efficacy and safety of LIV-GAMMA SN Inj. in~     adult subjects with ITP. The primary objective of this study is to determine the responder~     rate. A response is defined as a platelet count of ≥30×10^9/L and at least a 2 fold increase~     of the baseline, confirmed on at least 2 separate occasions at least 7 days apart without~     bleeding. The secondary objectives are to evaluate the further efficacy assessments including~     duration of response, and the safety of LIV-GAMMA SN Inj.~   "
30723|NCT03164902|"~     This study evaluates the ability of digital medicines, Proteus Discover, to promote adherence~     and thus achieving a cure for hepatitis C in patients at high risk for not adhering to their~     hepatitis therapy. In this single-arm, prospective study, subjects at high risk for~     nonadherence will be prescribed hepatitis C therapy that will be co-encapsulated with~     ingestible sensors (creating the digital medicine) by a pharmacy. Both the subject and the~     providers will have access to the ingestion adherence.~   "
30724|NCT03164889|"~     Previous studies indicated that Granulocyte Macrophage-colony Stimulating Factor (GM-CSF)~     could improve survival rate in patients with acute liver failure and obtain higher HBsAg~     seroconversion rate when in combination with peg-interferon for chronic hepatitis B (CHB)~     patients. In this study, investigators will study the clinical effect of entecavir (ETV) plus~     GM-CSF in patients with CHB compared to ETV monotherapy.~   "
30725|NCT03164876|"~     This study will investigate the safety, tolerability, PK and PD profile of AUT00206 after~     repeated doses in patients with stable but symptomatic schizophrenia, taking one or two~     established anti-psychotic drugs. The subjects will undergo brain imaging, tests of cognition~     and tests of auditory function and electrophysiological measures in addition to routine~     safety monitoring. Because of the pioneering and novel mechanism of action of this drug, a~     key objective is to characterize this range of biomarkers which will inform the future~     development of the drug.~   "
30726|NCT03164863|"~     Millions of cancer patients every year receive chemotherapy with only a 20-60% probability of~     pathological response, while most experience adverse side effects that lower quality of life~     without prolonging it. Reliable identification of ineffective therapies can eliminate~     needless human suffering while increasing overall probability of positive response to~     treatment. Chemotherapy resistance profiling entails testing whether a patient exhibits~     strong resistance to a therapy prior to its final selection by the oncologist. However, there~     are no effective methods for quickly assessing patient chemotherapy resistance. Patient~     Derived Xenograft (PDX) models have replaced older Chemotherapy Sensitivity and Resistance~     Assays (CSRAs) to some degree, but both technologies suffer from long testing times, high~     cost, and/or low accuracy.~      Motility Contrast Tomography (MCT) has recently emerged as a technology that measures the~     biodynamic response of intact tumor biopsies to applied therapeutics by using Doppler~     detection of infrared light scattered from intracellular motions inside living tissue.~     Several small scale animal, xenograft, and human studies have shown this phenotypic profiling~     technique to be highly accurate in prediction of response and resistance to chemotherapy.~     This project will be the first human trial of biodynamic phenotyping to predict chemotherapy~     response among breast cancer patients. Specifically, the study cohort will include patients~     selected for neoadjuvant chemotherapy treatment, because this setting offers the opportunity~     for near-term outcome measurement at the time of post-chemo surgery. Pre-therapy fresh tumor~     specimens will be imaged using MCT, and the resulting bio-dynamic signatures will be compared~     to confirmed pathological response at the time of surgery. Observation of a high predictive~     value will provide the basis for expanded clinical trials and prompt commercialization of a~     biodynamic chemotherapy selection assay for breast and other cancer patients.~   "
30727|NCT03164850|"~     During laparoscopic surgery, video camera becomes a surgeon's eyes since the surgeon uses~     image from the video camera positioned inside the patient's body to perform the procedure.~     The greatest limitation is the impairment or complete lack of tactile sensation normally used~     to assist in surgical dissection and decision making. The Investigator proposes to develop a~     tactile sensing system, Laparoscopic Tactile Imager (LTI), to be used in urogynecological~     laparoscopic surgery for tactile imaging and tissue characterization (elasticity, structure,~     boundaries, blood vessel detection) which will be imposed on the video image at area of~     interest in real time.~   "
30728|NCT03164837|"~     This is an open-label positron emission tomography/computed tomography (PET/CT) study to~     investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-RM26 in prostate~     cancer patients. A single dose of 111-148 Mega-Becquerel (MBq) 68Ga-NOTA-RM26 will be~     injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT~     images.~   "
30729|NCT03164824|"~     The purposes of this study were to conduct cross-cultural adaptation of the Functional Rating~     Index (FRI), to test psychometric properties of the translated questionnaire and to examine~     head-to-head comparisons with other questionnaires.~   "
30730|NCT03164811|"~     The investigators will do the Goal directed fluid therapy by protocolized fluid management in~     the experimental group, using PPV to guide the fluid administration, compare with standard~     fluid management in patients undergoing complex spine surgery.~   "
30731|NCT03164798|"~     This study aims to develop the quantitative biomarker to establish the individualized~     strategy in stroke rehabilitation. Brain-derived neurotrophic factor (BDNF) acts on certain~     neurons of the central nervous system (CNS) helping to support the survival of existing~     neurons, and encourage the growth and differentiation of new neurons and synapses. BDNF in~     CNS can be assessed by analysing serum BDNF. The final objective of this study is to~     demonstrate a role of biomarker of BDNF in stroke rehabilitation to establish the~     individualized strategy.~   "
30732|NCT03164785|"~     The purpose of this study is to investigate the therapeutic effect and safety of Jinshuibao~     Capsule on diabetic kidney disease in T2DM patients.~   "
30733|NCT03164772|"~     This is an open-label multicenter 2-arm study to evaluate the safety and preliminary efficacy~     of the addition of a vaccine therapy to 1 or 2 checkpoint inhibitors for NSCLC.~      Arm A: mRNA Vaccine [BI 1361849 (formerly CV9202)] + anti-PD-L1 [durvalumab] Arm B: mRNA~     Vaccine [BI 1361849] + anti-PD-L1 [durvalumab] + anti-CTLA-4 [tremelimumab]~      For each arm of the study, there is a dose escalation phase in which the Recommended~     Combination Dose (RCD) is determined according to a standard 3 + 3 design. The dose~     escalation phase is followed by an expansion phase, in which the cohort at the RCD is~     expanded to 20 subjects (inclusive of the subjects from the dose escalation cohort).~   "
30734|NCT03164759|"~     Correlate the implant stability quotient values measured by ostell device with radiographic~     bone density measured on CBCT by bluesky software pre-operatively~   "
30761|NCT03164408|"~     The necessity of orthopedic implant removal is under intense discussion and even if it is~     performed as an elective procedure, the risk of complications is present.~      Aim of the study is to identify parameters responsible for an increased risk of early~     post-operative complications after elective aseptic orthopedic implant removal.~   "
30735|NCT03164746|"~     Severe injurious behaviors in children with autism spectrum disorder are challenging. First~     line treatment approaches include behavioral techniques but pharmacotherapy is frequently~     required despite frequent adverse effects in youths.~      Therapeutic body wraps has been reported in small series or case reports, but has never been~     assessed in the context of a randomized controlled trial.~      The present study is an exploratory, multicenter, randomized, controlled, open label with~     blinded outcome assessment (PROBE design) trial of the effect of wet versus dry therapeutic~     body wraps in children presenting with autism spectrum disorder and severe injurious~     behavior.~   "
30736|NCT03164733|"~     Wear is the main reason for revision operations after joint arthroplasty. While the survival~     of modern implants is often longer than the expected life span in old patients, young~     patients (<60 years) have to expect at least one wear induced revision operation. The reason~     is the throughout all registries consistantly significantly reduced implant survival rates in~     young patients. In the swedish arthrplasty registry the 15 year survival for patients older~     than 75 years is 95 % and for those younger than 50 years is 75 %. This corresponds to a~     5fold increased revision rate (5 % vs. 25 %) 15 years after implantation. This significant~     difference cannot be explained by the higher activity of younger patients alone. Patient~     specific factors, that modulate the biological reaction on wear particles, are therefore~     highly probable. These could explain the significant age dependency of implant survival.~      The main hypothesis of this study is therefore, that the biological reaction on wear~     particles depends on the patients age.~   "
30737|NCT03164720|"~     Systemic lupus erythematosus (SLE) is a chronic inflammatory autoimmune disease affecting~     many organ systems. SLE includes a wide spectrum of severity, ranging from relatively mild~     manifestations (e.g. skin rash or non-erosive arthritis) to seriously disabling or even life~     threatening complications, such as lupus nephritis (LN) and neuropsychiatric disorders . LN~     is one of the most serious SLE complications since it is the major predictor of poor~     prognosis .~      Lupus nephritis is a common major organ manifestation and main cause of morbidity and~     mortality of the disease . It is occurred in 30-50% of SLE patients at initial diagnosis and~     more prevalent in Asians and Blacks than other races . Approximately, 10-30% of LN patients~     will develop the end-stage renal disease (ESRD) within 15 years after diagnosis. The 5-year~     survival rate of a patient with severe LN is less than70-80%. Therefore, an involvement of~     renal disease activity is one of the most important prognostic factors for patients with SLE,~     and the diagnosis of SLE patients with LN has an important clinical implication in guiding~     the treatment of SLE in clinical settings.~   "
30738|NCT03164707|"~     Coronary atherosclerosis is the leading cause of death worldwide. Diabetes mellitus is~     associated with increased prevalence of coronary artery disease~      Increased plasma glucose is a common feature in the acute phase of myocardial infarction,~     even in patients without diabetes. Patients with stress hyperglycemia, but without previous~     diagnosis of diabetes, were at increased risk of congestive heart failure, arrhythmia and~     cardiogenic shock as well as increased both in-hospital and long-term mortality . Previous~     studies have demonstrated larger infarct size and poorer prognosis inpatients with~     hyperglycemia upon hospital admission compared with patients without hyperglycemia~      It has been reported that stress hyperglycemia impairs microvascular circulation and may lead~     to no-reflow phenomenon. No reflow phenomenon was significantly more frequent among patients~     with hyperglycemia and increased progressively with increasing admission blood glucose in~     patients with Acute Myocardial Infarction . Furthermore, patients with high admission glucose~     are more likely to develop restenosis and require repeat revascularization procedures~     compared with those with normal admission glucose and are also at increased risk for repeated~     Myocardial Infarction, stent thrombosis and death.~   "
30739|NCT03164694|"~     The purpose of this study is to studying the addition of apatinib with chemotherapy to~     investigate the efficacy and safety of apatinib in combination with chemotherapy in patients~     with advanced NSCLC.~   "
30740|NCT03164681|"~     Contrast Induced Nephropathy is an acute renal insufficiency defined as a 25% or 0.5 mg/dl~     increase over the baseline of the serum creatinine level 24 h to 72 h after intravascular~     administration of a contrast agent.~   "
30741|NCT03164668|"~     The purpose of this formative study is to provide preliminary data regarding how the~     availability of menthol flavored e-cigarettes affects tobacco use behavior in the context of~     a ban on menthol flavored cigarettes~   "
30742|NCT03164655|"~     National trial, multicenter, randomized, phase II comparing treatment intensification with~     hepatic arterial infusion chemotherapy plus systemic chemotherapy (CT) to systemic~     chemotherapy alone in patients with liver-only colorectal metastases (CRLM) considered still~     non resectable after at least two months of systemic induction chemotherapy.~   "
30743|NCT03164642|"~     This project will determine whether an intervention to enhance communication between infants~     and toddlers with developmental disabilities and their depressed mothers can be integrated~     into federally-funded Early Intervention (EI) services. Participants will be mothers with~     depressive symptoms whose children are receiving EI services, along with their EI service~     providers.~      The investigators will conduct a small randomized control trial using the Language~     ENhancement Assessment/intervention system (LENA), a technology-supported language monitoring~     system, with 20 mothers and one of their child's EI service providers. The LENA uses an~     infant or toddler garment with an integrated audiotape system that records adult speech~     centered on the child, child vocalizations, and reciprocal parent-child turn-taking~     conversations. The LENA software produces visual feedback that a mother can use to focus her~     language interactions with her child. A LENA with feedback group will follow participants~     in the intervention over 5 weeks: 5 weeks of LENA data collection (with mothers running the~     system 1 day/week for 16 consecutive hours), with feedback during 3 weeks (baseline=LENA, no~     feedback; 3 week intervention=LENA with feedback; post-intervention=LENA, no feedback). A~     LENA no feedback group will complete LENA data collection at baseline on the same schedule~     but will not receive feedback. The main difference between groups will be provision of LENA~     feedback and strategies to promote increased mother-child interactions. This design allows~     the investigators to isolate the effect of LENA with feedback, and minimizes attributing~     changes in language environments due to exposure to LENA alone. The investigators will~     analyze data from measures on LENA communication data (adult word count, child vocalizations~     and conversational turn-taking), and measures of child language, maternal depressive~     symptoms, and child disability profiles.~   "
30744|NCT03164629|"~     The purpose of this research study is to learn about how cone-beam Computerized Tomography~     scans (X-ray images taken from different angles) work together with an embolization guidance~     software (helps the doctor see the arteries that feed the prostate)to find and see arteries~     in the prostate.~   "
30762|NCT03164395|"~     This study seeks to determine the efficacy of single coil defibrillation leads for~     cardioversion of persistent atrial fibrillation.~   "
31230|NCT03158285|"~     The primary purpose of this study is to evaluate the efficacy of guselkumab treatment in~     participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and~     symptoms of PsA.~   "
30745|NCT03164616|"~     This is a randomized, open-label, multi-center, global, Phase III study to determine the~     efficacy and safety of durvalumab + tremelimumab combination therapy + Standard of care (SoC)~     chemotherapy or durvalumab monotherapy + SoC chemotherapy versus SoC chemotherapy alone as~     first line treatment in patients with metastatic non small-cell lung cancer (NSCLC) with~     tumors that lack activating epidermal growth factor receptor (EGFR) mutations and anaplastic~     lymphoma kinase (ALK) fusions.~   "
30746|NCT03164603|"~     This is an open-label Phase I study to evaluate the safety, tolerability, and~     pharmacokinetics of escalating oral doses of NLG802, an investigational agent intended to~     inhibit the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme and help the human immune system~     attack solid tumor cells more effectively.~   "
30747|NCT03164590|"~     This study aims to compare the effects of local wound infiltration with ketamine versus~     dexmedetomidine when added to bupivacaine on inflammatory cytokine response after total~     abdominal hysterectomy.~   "
30748|NCT03164577|"~     This study is focused on conducting a stage 1b feasibility pilot trial among 60 AI/AN men and~     women (for a final sample of 48 at follow-up) in an urban outpatient treatment setting to~     analyze the potential benefits of Drum-Assisted Recovery Therapy for Native Americans~     (DARTNA). Dr. Dickerson, Principal Investigator, is collaborating with Dr. Elizabeth D'Amico,~     co-Investigator, with Sacred Path Indigenous Wellness Center, a community-based organization~     providing consultative services for American Indians/Alaska Natives (AI/ANs).~      A feasibility randomized clinical trial will be conducted within an urban setting and will~     compare urban AI/AN males and females with AOD disorders who receive DARTNA (n=30) to AI/AN~     males and females with AOD disorders who receive usual care plus (n=30). Compare outcomes at~     end of treatment and 3-months post-treatment to gather data that can be used to judge the~     feasibility of a larger trial, and to plan that trial. Obtain information on (a) clinically~     significant changes in AOD use, (b) clinically significant changes in mental health, physical~     health, spirituality, cognition, adoption of 12-step principles and practices, and cultural~     identification, and (c) estimate covariate correlations, reliability of measures and likely~     effect sizes.~   "
30749|NCT03164564|"~     This study will evaluate the safety and efficacy of the long-acting injectable agent~     cabotegravir (CAB LA) compared to daily oral tenofovir disoproxil fumarate/emtricitabine~     (TDF/FTC) for pre-exposure prophylaxis (PrEP) in HIV-uninfected women.~   "
30750|NCT03164551|"~     The main purpose of the study is to evaluate the overall clinical value of GERI+ as an~     integrated embryo culture and assessment system, providing an undisturbed culture~     environment, continuous monitoring of embryo development and automated scoring using a~     predictive algorithm.~   "
30751|NCT03164538|"~     The focus of this study is to examine the feasibility, acceptability, and impact of a~     customized, combined positive psychology and motivational interviewing (PP-MI) health~     behavior intervention versus a diabetes education intervention in a group of patients with~     type 2 diabetes (T2D).~   "
30752|NCT03164525|"~     The prospective study set forth to test Thai version CPOT and BPS for validity, reliability,~     and practicality. After translation, both pain scales were tested for concurrent validity,~     discriminant validity, criterion validity, and inter-rater reliability in patients who were~     intubated during the postoperative period. Opinions regarding practicality were elicited via~     questionnaires from nurses who had been using and were familiar with these two pain scales.~   "
30753|NCT03164512|"~     This study will evaluate the pharmacokinetics and pharmacodynamics of cannabidiol~     administered via inhalation and oral ingestion.~   "
30754|NCT03164499|"~     This is a randomized controlled trial aimed to design an intensive intervention to modify~     lifestyles of subjects with intermediate cardiovascular risk and evaluate its effectiveness.~     200 participants aged 35-74 years who have intermediate cardiovascular risk will be included.~     Subjects will be selected by consecutive sampling at urban primary care health centers from~     Salamanca (Spain) and they will be randomized to a control or an intervention group. Both~     groups will receive individual standardized counselling on healthy diet, daily physical~     activity, smoking cessation, and moderation in alcohol consumption. Moreover, individuals~     from the intervention group will receive additional group counselling and follow-up calls.~     The effect of the intervention will be assessed using lifestyles and quality of life~     questionnaires, metabolic control parameters, inflammation markers, anthropometric and~     vascular function measurements, and neuropsychological tests.~   "
30755|NCT03164486|"~     This clinical trial studies the side effects of 18F-alphavbeta6-binding-peptide and how well~     it works in imaging patients with primary or cancer that has spread to the breast,~     colorectal, lung, or pancreatic. Radiotracers, such as 18F-alphavbeta6-binding-peptide, may~     improve the ability to locate cancer in the body.~   "
30756|NCT03164473|"~     The purpose of this study is to investigate, after achievement of remission, the efficacy of~     rituximab compared with azathioprine maintenance therapy on duration of remission, in~     patients with relapsing or newly-diagnosed Eosinophilic granulomatosis with polyangiitis EPGA~     receiving standard of care therapy including glucocorticoid therapy reduction/withdrawal.~   "
30757|NCT03164460|"~     The goal of this research study is to compare the effectiveness of stereotactic body~     radioablative therapy (SBRT) to conventional radiation therapy in patients with head and neck~     cancer who are receiving repeat radiation.~      This is an investigational study. Conventional radiation therapy and SBRT are delivered using~     FDA-approved and commercially available methods. The study doctor can explain how each method~     of delivering radiation is designed to work.~      Up to 100 participants will take part in this study. All will be enrolled at MD Anderson.~   "
30758|NCT03164447|"~     This study evaluates the efficacy, safety, and tolerability of UB-421 in conjunction with an~     existing failing antiretroviral therapy (ART) for 2 weeks and optimized background therapy~     (OBT) for 24 weeks, respectively.~   "
30759|NCT03164434|"~     This observational study investigates ICP signals obtained through an external ventricular~     drain in the brain connected with an external transducer. In particular, the study~     investigates how drainage influences the monitored signal: influence of flow rate, reservoir~     height and initial ICP before draining.~   "
30760|NCT03164421|"~     N-Acetylcysteine and L-carnitine were used in pcos patients~   "
31231|NCT03158272|"~     The purpose of this study is to determine whether an investigational immuno-therapy,~     cabiralizumab in combination with nivolumab, is safe and tolerable in the treatment of~     advanced malignancies.~   "
30765|NCT03164356|"~     The purpose of the proposed study is to conduct research on individuals with lower limb~     amputation, evaluating if residual limb fluid volume data collected using a novel~     non-invasive device is beneficial towards prosthetic prescription, fit, and comfort as~     determined by amputee test subjects and practitioners (prosthetists). Participants' residual~     limb fluid volume will be monitored through bioimpedance analysis both before and after a~     practitioner-issued modification to the prosthesis as an observational cohort study and then~     as a blinded randomized control trial in which the data may or may not be shared with the~     practitioner before the modification is made to the prosthesis.~   "
30766|NCT03164343|"~     The primary objective of this study is to examine whether Pain Neuroscience Education for~     children is able to increase a child's knowledge on the neurophysiology of pain.~      In addition, this study investigates the influence of PNE on several pain related outcomes;~     pain-related fear, pain catastrophizing and pain vigilance and awareness.~   "
30767|NCT03164330|"~     Workplace wellness programs have become a $6 billion industry and are widely touted as a way~     to improve employee well-being, reduce health care costs by promoting prevention, and~     increase workplace productivity. Yet, there is little rigorous evidence available to support~     these claims, partly because the voluntary nature of these programs means that participants~     may differ from nonparticipants for reasons unrelated to the causal effects of the wellness~     program. The investigators will implement a randomized control trial to identify the effects~     of incentives on wellness program participation, produce causal estimates of the effect of~     wellness programs on health outcomes, determine what kinds of employees benefit from wellness~     programs the most, and test for the presence of peer effects in wellness participation.~   "
30768|NCT03164317|"~     This study evaluates the effect of a mobile health technology enabled trained nurse led~     intervention on control of blood pressure among patients with hypertension seeking care in~     the community health centres in the southern state of Andhra Pradesh, India. half the~     community health centres will receive the intervention and the other half will receive the~     routine care.~   "
30769|NCT03164304|"~     Preeclampsia is commonly viewed as one of the hypertensive pregnancy disorders, which cover a~     spectrum of clinical presentations from chronic hypertension ( hypertension occurring prior~     to 20 weeks of gestation) and gestational hypertension (hypertension occurring after 20 weeks~     of gestation) To more severe forms, including preeclampsia, eclampsia (its convulsive form),~     and HELLP syndrome (hemolysis, elevated liver enzyme S, and low platelets)~   "
30770|NCT03164291|"~     Treatment of adults with chronic Mycobacterium avium-intracellulare complex lung infections~     who have failed or are intolerant of rifampin.~      Rifabutin may be a reasonable alternative agent in patients who fail rifampin or or~     intolerant of rifampin.~   "
30771|NCT03164278|"~     The objective of this research study is to assess the effectiveness of an independent~     transfer training program (ITTP), and to determine methods which may increase overall success~     of an online training program.~   "
30772|NCT03164265|"~     Phase I/II, single center, prospective, open-label, non-controlled, non-randomized,~     interventional, cohort study in which low risk living donor liver transplant (LDLT)~     recipients will receive a single infusion of donor-derived DCreg 1 week prior to~     transplantation. All patients will be maintained on MPA and Tacrolimus (Tac) for the 1st 6~     months after transplantation. At that time point, recipients meeting specific criteria will~     be slowly weaned off MPA per standard of care over a period of 6 months. Participants will~     then be evaluated for TAC weaning at 1 yr after transplantation. Those who meet specific~     criteria be weaned off Tac over 6 months . Successfully weaned participants who remain~     rejection-free will undergo 3 years of follow-up after the last dose of immunosuppression.~   "
30773|NCT03164252|"~     The low-power laser provides the body with an improvement in the inflammatory response. Thus,~     the objective of this study is to evaluate two laser application protocols in 60 patients~     requiring surgical treatment for extraction of third molars included, without distinction of~     race or gender, aged between 16 and 40 years, coming from the Faculty of Dentistry Of São~     José dos Campos (UNESP). These patients will be divided randomly into 3 groups: group 1 -~     intraoral irradiation with 660 nm laser at a dose of 10 J (30 mW, 10 J / cm 2) , group 2 -~     intraoral irradiation with 660 nm laser at a dose of 30 J (30 mW, 30 J / cm 2) and group 3-~     control group, with application of placebo laser. At 3 and 7 days after surgery, the patients~     will be evaluated by two evaluators who will measure edema, trismus and pain. The tissue~     repair will also be evaluated after 1, 3 and 6 months of surgery, through radiographic~     analysis and periodontal conditions in the distal of the lower second molar. The results will~     be submitted to descriptive statistics and compared using the statistical analysis of~     variance (ANOVA) and Tukey test with significance level of 5%.~   "
30774|NCT03164239|"~     The purpose of this regional parallel-group RCT was to assess the effect of a six-month~     tailored telephone and email based physical activity intervention on various measures of~     physical fitness and body composition in a sample of physically inactive adults. A total of~     111 physically inactive adults (40-55yr) from Agder, Norway were randomly allocated to either~     an intervention group (IG;n=56) or a no-intervention control group (CG;n=55). The IG received~     tailored exercise recommendations, every two months by email or mail (print) in addition to~     motivational follow-ups every second week, alternatively by email and telephone. Primary~     outcome measures were various objective measures of musculoskeletal and cardiorespiratory~     fitness in addition to various measures of body composition, including waist circumference,~     body mass index and fat percentage, which were assessed pre- and post-intervention.~   "
30775|NCT03164226|"~     The objective of this study is to verify the contribution of digital plethysmography in the~     early diagnosis of acute coronary syndrome in emergency departments.~      To determine the sensitivity, specificity, negative and positive predictive value of this~     method that was not previously used for this purpose.~   "
30776|NCT03164213|"~     The purpose of this study is to investigate effects of tDCS stimulation in the left primary~     motor area followed by naming therapy to improve language functions in patients with aphasia~     in the sub-acute stage.~   "
30827|NCT03163550|"~     This Phase 1 clinical study is a double-blind, randomized, placebo-controlled, parallel group~     study to assess the safety, tolerability, pharmacokinetics (PK), food effect, and drug~     interaction potential of ACHN-383 and ACHN-789 co-administered orally as separate capsules in~     healthy subjects~   "
30777|NCT03164200|"~     Aging is associated with an increased risk for metabolic diseases, such as type 2 diabetes~     and cardiovascular disease. There is reason to believe that the time of day when specific~     food groups are eaten affects this risk. The investigators propose that eating foods made up~     of fat and protein (such as eggs) in the morning for breakfast, rather than foods made up of~     carbohydrates (such as white-bread toast or sugary cereal) may promote a healthier~     metabolism. This is because the body is designed to burn fat during times of fasting, such as~     overnight, during sleep. Thus, the body is not prepared to burn sugar early in the morning,~     when most people eat breakfast. Studies with mice have shown that a sugary breakfast meal~     inhibits the ability of the body to burn fat for the entire day. In contrast, a breakfast~     meal with more fat enabled the animals to burn fat as well as other fuels throughout the day.~     The ability to burn fat is thought to minimize risk for obesity, as well as related diseases~     such as type 2 diabetes and heart disease. The purpose of this study is to determine if, in~     older adult humans, consumption of a lower-carbohydrate breakfast meal (relative to a~     higher-carbohydrate meal) is associated with a healthier metabolism.~   "
30778|NCT03164187|"~     The aim of this study is to analyze the efficacy of Diabeton 60 MR as intensive~     sugar-lowering therapy into routine clinical practice, in patients for whom the treating~     physician has already decided to prescribe this medication. This concerns untreated newly~     diagnosed patients uncontrolled by diet, and patients uncontrolled by metformin.~   "
30779|NCT03164174|"~     The study is a prospective-observational, explorative single-centre cohort study aimed to~     examine the atherosclerosis progression in coronary arteries compared to peripheral vessels~     (carotids, femoral arteries). Atherosclerotic alterations in peripheral vessels (IMT, plaque~     volume, plaque morphology) will be measured with ultrasound (IMT measurements and 3D~     quantitative plaque volumetry), whereas atherosclerotic alterations in coronary arteries will~     be tested with cardiac computertomography (CT) (coronary artery calcium score, calcium volume~     score, plaque morphology).~      A total of 55 patients without prior known established vascular diseases will be tested.~     Cardiac CT and ultrasonography will be performed initially. After 2 years follow-up CT and~     ultrasound examination will be performed to assess the changes in atherosclerotic burden.~     Initially and after two years plasma samples will be collected and tested for traditional and~     novel cardiovascular risk factors.~      The primary endpoint of the planned study will be the correlation of the atherosclerotic~     progression between coronary arteries and peripheral arteries (carotids, femoral arteries).~      Secondary endpoints will include the correlation of atherosclerotic progression with~     established (hypertension, smoking, diabetes, dyslipidemia) and novel risk factors (hsCRP,~     P-selectin, cholesteryl ester transfer protein (CETP), intercellular adhesion molecule-1~     (ICAM-1), CETP TaqIb polymorphism), with cardiovascular event rate, and the additional~     predictive value of atherosclerotic progression compared to an established risk score (SCORE~     Card, FRS). Also plaque morphology will be compared between coronary arteries and peripheral~     vessels.~   "
30780|NCT03164161|"~     The purpose of this study is to evaluate the correlation between β-endorphin levels in blood~     plasma and saliva in healthy participants with different pain sensitivity and in those with~     acute pain in oral and maxillofacial region.~      Expected results~        -  Relation between blood plasma and saliva β-endorphins levels~        -  Differences of blood plasma β-endorphins levels in healthy participants with different~          pain sensitivity and in those with acute pain~        -  Differences of saliva β-endorphins levels in healthy participants with different pain~          sensitivity and in those with acute pain~        -  Objective method of patient's pain sensation evaluation~        -  Correlation between patient's self-reported understanding of pain levels in oral surgery~          procedures, levels in saliva and blood plasma β-endorphins levels and sensitivity to~          cold test results~      Study protocol:~      Selection of participants~        1. Evaluation of pain perception in oral surgery procedures by healthy adult participants.~        2. Groups formation, according to the results from first stage, resulting in high and low~          pain rating participants groups.~        3. Control group formation from patients with acute pain in oral and maxillofacial region~          Control rating of participants~      1. Patients that have been assigned to groups according to subjective pain ratings in oral~     surgery procedures will have to repeat the same questionnaire to ensure the correct group~     assignment.~      2. Patients that have been assigned to groups according to subjective pain ratings in oral~     surgery procedures, will undergo the sensitivity and tolerance to cold pain test.~      3. Patients that were assigned to control-acute pain group, will be included in further study~     stages only with clinically diagnosed cause of acute pain in oral and maxillofacial region to~     avoid possible psychogenic or general diseases pain.~      Evaluation of β-endorphins - sampling~        1. Saliva samples will be collected by all further included participants by one selves~          participants with researchers supervision.~        2. Blood samples will be collected from forearm veins by researcher. Evaluation of~          β-endorphins - laboratorial examination~      1. Levels of β-endorphins in saliva and blood will be evaluated according to manufacturer of~     β-endorphins evaluation kit for human research. Every sample will be evaluated twice and the~     mean level will be evaluated.~      Statistical analysis~      1. Statistical analysis will be produced to access all possible relationships~   "
30781|NCT03164148|"~     Several studies have been reported that heart rate is known to be associated with prognosis~     in chronic diseases and acute diseases. For example, a decrease in heart rate following~     myocardial infarction may lead to a higher mortality rate. It is also known to predict heart~     failure, diabetic neuropathy, and even depression.~      The combined pituitary function test artificially induces hypoglycemia to observe the~     secretion of pituitary hormone. The degree of change in heart rate during hypoglycemia can~     predict the adequacy of the test, and heart rate can be changed according to the~     characteristic of the tumor. Also, the prognosis can be predicted based on this.~      In our study, we used a licensed device approved by KFDA (Korea Food and Drug Administration)~     to measure heart rate variability in patients with pituitary adenoma.~   "
30782|NCT03164135|"~     The investigators performed this study to evaluate the safety and feasibility of~     transplantation with CRISPR/Cas9 CCR5 gene modified CD34+ hematopoietic stem/progenitor cells~     for patients that develop AIDS and hematological malignances. Patients will be treated with~     antiviral therapy (ART) to achieve undetectable HIV-1 virus in peripheral blood before~     conditioning. CD34+ cells from donors will be infused into the patients after treatment with~     CRISPR/Cas9 to ablate CCR5 gene.~   "
30791|NCT03164018|"~     Fampyra, a voltage-dependent potassium channel blocker, is indicated for the improvement of~     walking in adult patients with multiple sclerosis with walking disability (EDSS 4-7). The~     medicinal product has been authorized under a so-called conditional approval scheme. This~     means that further evidence on this medicinal product is awaited and this study aims to~     assess the effect of Fampyra, administered according to standard clinical practice, on~     cognition, fatigue and quality of life in patients with MS.~      This clinical study is a multicenter, prospective, non-interventional, cohort study of MS~     patients receiving Fampyra in outpatient setting. Patients will be treated according to the~     local prescribing information of the study medication and routine medical practice in terms~     of visit frequency and types of assessments performed. The assignment of the patient to this~     therapeutic strategy is not decided in advance by the study protocol but falls within current~     practice and the prescription of Fampyra is clearly separated from the physician's decision~     to include the patient in the current study.~      Since this is purely non-interventional study, primary data -which will be obtained~     prospectively during the study visits through patients' interview and patient reported~     outcomes or as performed per standard clinical practice- will mainly be employed.~   "
30783|NCT03164122|"~     Recently, the emergence of biotherapies has allowed the use of intra-articular injections of~     autologous plasma rich platelet (PRP). Their use is widespread since 2010 and is based on the~     demonstration that platelets-enriched plasma, by virtue of its growth factors concentration,~     stimulates in vitro and in vivo cartilage regeneration in preclinical models. Recent~     literature highlights that these autologous products are very well tolerated by humans. PRP,~     as an intra-articular injection therapy, seems to be an autologous biological medicine,~     innovative for cartilage injury reparation and showing good primary results for this~     indication.~      Adipose tissue contains stromal-vascular fraction (SVF), in which are located a large~     proportion of mesenchymal multipotent stem cells (Adipose-derived stem cells, ADSCs) able to~     differentiate into several cellular lines in vitro and in vivo, including cartilage cells.~      The association of microfat and PRP is interesting in order to potentiate trophic and~     regenerative effects on damaged cartilage site. The combination of these two products,~     respectively rich in autologous multipotent stem cells and growth factors, aims to create an~     optimal environment for cartilage cells regeneration. Furthermore, microfat semi solid phase~     is playing the role of a nutritive support matrix which contains and limits the diffusion and~     resorption of PRP liquid while allowing progressive growth factors release on the injection~     site.~      The hypothesis of this project is that standardized injection of an innovative treatment~     (microfat and autologous PRP) should allow delay the use of invasive surgical therapy in the~     treatment of wrist osteoarthritis. This minimally invasive treatment could provide a curative~     second line treatment in case of medical treatment failure.~   "
30784|NCT03164109|"~     This is a partially double-blind study in healthy adult subjects, which will be conducted as~     a placebo- and active-controlled, single-dose, crossover study.~      Twenty-eight subjects will be enrolled to ensure 24 subjects on all study periods. All~     subjects will receive all 3 study treatments (GC4419, placebo and moxifloxacin) in randomized~     sequence.~      Cardiodynamic assessment using continuous ECG recordings (Holters) will be performed for~     approximately 26 hours on the day of dosing (Day 1) in each study period. ECGs will be~     extracted serially pre- and post-dose and predefined timepoints at which subjects will be~     supinely resting.~      Subjects will be supinely resting for at least 10 minutes prior to and 5 minutes after each~     nominal timepoint for ECG extraction.~      Blood draws for PK will be performed in all periods at the same timepoints and always after~     ECG extraction.~      Subjects will be domiciled in the clinic from noon/afternoon of the day before dosing (Day~     -1) until completion of safety procedures on Day 2 in each study period.~      All subjects (including subjects who terminate the study early) will return to the clinical~     research unit (CRU) 14 (± 1) days after the last administration of study treatment for~     follow-up procedures and to determine if any Adverse Event (AE) has occurred since the last~     study visit.~   "
30785|NCT03164096|"~     Although the exact mechanism remains unknown, the association of pregnancy and decreased~     local anesthetic requirement is clear. demonstrated that more local anesthetic is required~     for cesarean section under combined spinal-epidural anesthesia in preterm compared with term~     patients.~   "
30786|NCT03164083|"~     Osteoarthritis of the knee is one of the most common causes of disability among elderly. As~     the disease progresses the cartilage become frustrated, surrounding bone react to become~     thicker and inflammation occurs in subchondral bone seen in T2-weighted MRI as increase in~     signal density. Patients are treated initially by pain management. In patients who don't~     response to first line treatment invasive treatment like total knee replacement is done. The~     investigators designed this clinical study with the aim of evaluating therapeutic effects of~     intra-articular injection of bone marrow Mesenchymal Stem Cells (MSC) and stromal Vascular~     Fraction (SVF) in patients with severe knee osteoarthritis~   "
30787|NCT03164070|"~     This study evaluates laboratory-based method to estimate the degrees of activity of medium~     and large joint osteoarthritis.~   "
30788|NCT03164057|"~     The overall aim of this study is to determine if epigenetic priming with a DNA~     methyltransferase inhibitor (DMTi) prior to chemotherapy blocks is tolerable and carries~     evidence of a clinical efficacy signal as determined by minimal residual disease (MRD),~     event-free survival (EFS), and overall survival (OS). Tolerability for each of the agents, as~     well as total reduction in DNA methylation and outcome assessments will be done to~     simultaneously obtain preliminary biological and clinical data for each DMTi in parallel.~      PRIMARY OBJECTIVES:~        -  Evaluate the tolerability of five days of epigenetic priming with azacitidine and~          decitabine as a single agent DMTi prior to standard AML chemotherapy blocks.~        -  Evaluate the change in genome-wide methylation burden induced by five days of epigenetic~          priming and the association of post-priming genome-wide methylation burden with~          event-free survival among pediatric AML patients.~      SECONDARY OBJECTIVES~        -  Describe minimal residual disease levels following Induction I chemotherapy in patients~          that receive DMTi.~        -  Estimate the event-free survival and overall survival of patients receiving a DMTi prior~          to chemotherapy courses.~   "
30789|NCT03164044|"~     Current study evaluates the use of the improved Basophil Activation Test (BAT) in the~     diagnostics of IgE-mediated allergy to antibiotics and non-steroidal anti-inflammatory drugs~     (NSAIDs).~   "
30790|NCT03164031|"~     Walking can be slow and unsteady in people with multiple sclerosis (MS). This study will~     investigate whether orthotic shorts might help.~      Orthotic shorts are similar to the tight clothing believed to improve performance in~     athletes. Research suggests that such shorts help stroke survivors to walk faster. Some~     people with MS find that similar garments improve coordination and stability. Public funding~     is controversial because there is no research investigating whether they work in people with~     MS.~      This is a cross-over study in which participants will each trial two different pairs of~     shorts. The first aim is to determine whether these shorts are acceptable to people with MS.~     Secondly, the study will develop the tools required to test the shorts. For example, by~     determining which measures seem most appropriate and if specific factors predict whether the~     shorts might help. The hypothesis being tested is that the shorts are acceptable.~      People with MS will be invited to participate in this mixed methods study, aiming for a~     sample size of 16 people. Participants will trial two different pairs of shorts, one of which~     will fit more closely than the other. The shorts will be tested in a movement laboratory and~     in daily life.~      In the movement laboratory, participants will be measured in both pairs of shorts and in~     normal, loose clothing. Walking pattern, speed and variability will be measured when the~     shorts are first worn.~      Participants will test shorts in their normal daily life for up to two weeks. They will~     complete questionnaires about their walking and balance in the different shorts and record~     how long they wear the shorts. Interviews will explore expectations and experiences of the~     shorts and of the research study.~      In the analyses, data from interviews will be combined with the numerical information gained~     from laboratory measures, diaries and questionnaires. If the shorts are acceptable, this~     study will inform a larger trial investigating effectiveness.~   "
30792|NCT03164005|"~     The investigators will enroll about 120 subjects from the hospital's healthcare center. The~     investigators will collect the basic informations, blood pressure, body mass index, fasting~     blood glucose and fasting blood lipids of each subject. The investigators will collect the~     blood samples and then test them for fasting insulin levels, VEGF-B levels, the gene promoter~     region methylation status and the genomic protein methylation levels of the VEGF-B gene of~     the cells，and finally do the statistical analysis.~   "
30793|NCT03163992|"~     This is a single-arm, single-center, open-label trial of pembrolizumab (MK-3475) in subjects~     with advanced hepatocellular carcinoma as second-line treatment after failure of sorafenib.~      Approximately 60 subjects will be enrollment to evaluate the efficacy and safety of~     pembrolizumab.~      Enrollment will begin with all subjects without regard for PD-L1 expression status.~      An evaluable specimen for PD-L1 status must be available and confirmed prior to enrollment.~      All study subjects will be evaluated every 6 weeks (+/- 7 days) following the date of IP drug~     adminstration for the first 12 months and every 12 weeks (+/- 7 days) thereafter until~     progression of disease is documented with radiologic imaging (computed tomography or magnetic~     resonance imaging).~      The primary efficacy endpoint is ORR (objective response rate) per RECIST 1.1.~   "
30794|NCT03163979|"~     Cisplatin-based chemoradiation (CCRT) has been considered as the standard care for patients~     with locally advanced cervical cancer (LACC). Nevertheless, increasingly more radio-resistant~     tumors still recur. IMRT including Rapid-Arc have obvious advantage in the dose distribution~     and organ protection, and positron emission tomography (PET) with F-18 fluorodeoxyglucose~     (FDG) and Comet analysis have good sensitivity for detecting sites and radiosensitivity of~     disease. These may be helpful to individualized CCRT of LACC.~      Three hundred LACC patients are enrolled in the study, who were with FIGO stages IB2-IVA and~     had no para-aortic lymphadenopathy (>10 mm) assessed by PET-CT or MRI. All the patients~     received definitive radiotherapy consisting of external beam whole pelvic RT and HDR-ICBT.~     The cumulative linear quadratic equivalent dose (EQD2) was 70-75Gy prescribed at point A.~     Cisplatin 30 mg/m2 weekly was administered concurrently for 5 courses. 2-4 cycles TP (Taxol~     135 mg/m2, D1 and DDP 25 mg/m2, D1-3) regimen sequential chemotherapy were performed if~     complete response (CR) not achieved according to magnetic resonance imaging (MRI) or PET-CT~     after CCRT. Hypothesis of the study is that CCRT and sequential chemotherapy is safe. Based~     on FDG-PET/CT and Comet assay, higher doses can be safely delivered individually to accurate~     tumor volume, while the doses to bladder and rectum are relative low. Comet and~     FDG-PET/CT-guided IMRT including RapidArc may improve survival in terms of time to~     progression (TTP), progression-free survival (PFS) and overall survival (OS) and less~     treatment-related toxicity. The data will be observed and analyzed.~   "
30795|NCT03163966|"~     CR6086 is a new, potent and selective, orally available, small molecule prostaglandin EP4~     receptor antagonist, endowed with immunomodulatory properties. The pharmacological properties~     of CR6086, along with its oral bioavailability, predictable pharmacokinetics and good safety,~     make it the ideal candidate to be tested alone or in combination with methotrexate (MTX) in~     patients with early Rheumatoid Arthritis who are naïve to Disease-Modifying Antirheumatic~     Drugs (DMARDs). The compound has indeed the potential to provide a safer and more effective~     treatment than MTX (or other conventional synthetic DMARDs - csDMARDs), and could~     significantly improve the proportion of responder patients and avoid/delay the recourse to~     biological DMARDs (bDMARDs) or targeted synthetic DMARDs (tsDMARDs).~   "
30796|NCT03163953|"~     This study will determine the effect of physical activity promotion based on Thai Physical~     Activity Guideline (TPAG) and break in workplace sitting on physical activity level, physical~     fitness, body compositions, cognitive functions and cardiometabolic biomarkers in office~     workers at Software Park Thailand under the Office of Science and Technology (NSTDA). There~     are two intervention including physical activity (PA) coaching based on TPAG and break in~     workplace sitting. The investigators will coach participants for promoting daily active life~     and participating to monthly exercise programs. The participants will be assign to break in~     sitting during daily work.~   "
30797|NCT03163940|"~     The present study will adopt a non-blinded parallel-group randomized controlled trial design~     that involves a Laughter Yoga group (intervention) and a treatment-as-usual group (Control).~     It aims to determine the feasibility of using LY intervention on patients with Major~     depressive disorder (MDD), and also to evaluate the potential effect of the intervention on~     comorbid depression, anxiety and stress for these patients. It is hypothesized that, LY~     group, as compared to the TAU group, will have significantly lower symptoms of depression,~     anxiety and stress, but greater improvements in self-reported mental health/physical~     health-related quality of life immediately post intervention and at 3 months' follow-up.~   "
30798|NCT03163927|"~     This study will investigate the effect of simulation-based training with mastery learning~     (SBML) on novice performers' lumbar puncture (LP) performance in a clinical setting. The~     study will investigate the effect on operators' performance, stress level, and on patient~     experienced stress, confidence in operator, and patient-related outcomes of pain, and risk of~     subsequent Post Dural Puncture Headache (PDPH), and days of sickness leave.~      The study will compare the effect of the training to a control group of novices receiving~     standard training and additionally to an intermediate and an expert group.~      The study will provide insight into the translational effect from the simulation based~     setting to clinical performance. Further, the study will explore: if stress decreases~     operators' performance; if operators stress affects the patient stress level; and the effect~     of SBML on patient-related outcomes.~   "
30799|NCT03163914|"~     96 pregnant patients will be enrolled in this study. Participants will divide in to 3 groups.~     Spinal anaesthesia will perform with 5% marcain heavy 2 ml+20 microgram fentanyl to the all~     patients. After performed spinal anaesthesia, vasopressor infusion will be started~     intravenously. Epinephrine will prepare 5 mg/ml and infusion rate will adjust 30 ml/h for~     Group E. Norepinephrine will prepare 5 mg/ml and infusion rate will adjust 30 ml/h for Group~     NE. Phenylephrine will prepare 100 microg/ml and infusion rate will adjust 30 ml/h for Group~     P. If systolic blood pressure decrease 20% of basal value or below to 100 mmHg, bolus~     ephedrine will apply intravenously (IV). If heart rate will decrease 60 beat per min or 20%~     of basal value, atropine will apply IV.~   "
31250|NCT03158025|"~     The primary purpose of this study is to evaluate the abuse potential of lemborexant (E2006)~     in comparison to placebo and 2 controls with known abuse potential (ie, zolpidem and~     suvorexant) with similar indications (zolpidem and suvorexant) or mechanisms of action~     (suvorexant).~   "
30801|NCT03163888|"~     Total knee arthroplasty (TKA) is a well-established modality for the treatment of advanced~     knee osteoarthritis with high satisfaction rate. However, the traditional cutting jigs for~     distal femur cutting inevitably violates the medullary canal of femoral bone. The process of~     intramedullary reaming for the insertion of distal femur cutting jigs stimulated the~     dissipation of marrow emboli that reported lead to increased risk of myocardial infarction or~     cardiac stress perioperatively. There are emerging refinements aiming to reduce the insult to~     the medullary canal of the distal femur as well as to improve the prosthetic alignment, such~     as navigation assisted TKA or robotic surgery.~      In addition to better prosthetic alignment, computer-assisted navigation TKAs also mitigate~     perioperative blood loss and systemic emboli. The publication previously published by the~     investigators showed that navigation TKAs can lead to lesser extent of elevation of~     endothelial injury markers than the traditional TKAs. However, the detrimental effects of~     intramedullary reaming seem to be multi-dimensional and the whole picture has not been~     elucidated clearly at present.~      Previous studies have shown that operative trauma can trigger marked immune responses.~     Operative procedures can simultaneously stimulate the pro-inflammatory and anti-inflammatory~     response, with 80% of the leucocyte transcriptome being affected. Most studies of hip or knee~     surgery found that operation-triggered immune reactions are associated with postoperative~     recovery, infection, and even mortality.~      The navigation TKAs avoid the process of intra-medullary reaming, which is the mandatory part~     of conventional TKA for the distal femur cutting. The investigators hypothesize that the~     reaming process may exert substantial inflammatory response, which can be manifested by~     higher level of inflammatory markers in the serum and hemovac drainage samples obtained from~     the participants undergoing conventional TKAs.~   "
30802|NCT03163875|"~     Urticaria is one of the most frequent presenting complaints in dermatology, allergy, and~     emergency departments. The term chronic urticaria (CU) is understood as the appearance of~     recurrent wheals more than twice a week for over 6 consecutive weeks .Urticaria is not a~     single disease but a reaction pattern that represents cutaneous mast cell degranulation,~     resulting in extravasation of plasma into the dermis. The incidence of chronic urticaria is~     unknown, but it is thought to occur in 0.1%-3% of the population~   "
30803|NCT03163862|"~     This is a controlled preminary trial intended to increase the implantation rate of IVF~     cycles, by using more than one known procedure, endometrial scratching, evaluating the status~     of the adhesive factors as αVβ3 integrin, L-selectin ligand MECA-79, E-cadherin and ICAM-1,~     as a determinant for intervention by G-CSF, according to a score that can be done on a small~     sample obtained during scratching, then give G-CSF for the scores less than 4 intrauterine~     and subcutaneously.~   "
30804|NCT03163849|"~     Chronic hepatitis C virus infection affects an estimated one hundred and seventy million~     people around the world with and approximate prevalence 0.2-2 % in the United State of~     America and European countries.~   "
30805|NCT03163836|"~     Current European Society of Cardiology Guidelines recommend concomitant atrial fibrillation~     (AF) ablation for all symptomatic patients undergoing other cardiac surgeries, but the safety~     and potential benefits of concomitant atrial fibrillation (AF) ablation at the time of double~     valve replacement remains unexamined. A retrospective review of patients with AF who~     underwent double valve replacement with or without concomitant surgical ablation in our~     institute starting from April 2006.~   "
30806|NCT03163823|"~     This study will enroll 75 mechanically vented adults in the ICU to compare self-reported ease~     of communication, patient satisfaction, and patient anxiety and frustration levels between a~     group using a communication application on an iPad and a group using standard methods of~     communication while mechanically vented.~   "
30807|NCT03163810|"~     The purpose of this study is to determine whether low level laser therapy (LLLT) using the~     Erchonia VERJU and EVRL laser devices is effective in reducing aminoalanine transaminase~     (ALT) levels in individuals with nonalcoholic steatohepatitis (NASH).~   "
30808|NCT03163797|"~     Head and neck cancer (HNC) continues to be a significant health care problem in Taiwan and~     oropharyngeal squamous cell carcinoma (SCC) is the common subtype. With the concern of organ~     preservation in recent years, concurrent chemoradiation is the major treatment modality for~     oropharyngeal SCC. Endoscopy with biopsy serve as the main diagnostic tools in patients with~     oropharyngeal SCC. While computed tomography (CT) and magnetic resonance imaging (MRI) are~     commonly used to evaluate the tumor extent of HNC, MRI is more preferred in the oropharyngeal~     area by virtue of its high contrast resolution. With the advance of MRI technology, whole~     body MRI is now possible, and functional techniques become more feasible in the head and neck~     region, including diffusion-weighted imaging (DWI) which comprises of monoexponential DWI,~     IVIM (intravoxel incoherent motion) model and Kurtosis (biexponential or non-Gaussian~     fitting), and perfusion-weighted imaging (PWI) become feasible. Therefore, MRI can evaluate~     distant site status of HNC in the single examination session and provide biologic information~     of tumors, such as cellularity, angiogenesis and permeability, and so forth. Positron~     emission tomography/CT (PET/CT) is another common imaging modality to evaluate HNC, because~     of its ability to provide whole-body anatomic and metabolic information.~      Integrated PET/MRI is a novel imaging technology that combines PET and MRI in one single~     scanner. It can acquire both PET and MRI information simultaneously. Initial data convey that~     PET/MRI performed favorably in diagnostic evaluation of HNC. However, the predictive value of~     PET/MRI in treatment outcome of HNC has not been reported. A prospective study of integrated~     PET/MRI in a large cohort of patients with specific tumor origin and uniform treatment~     protocol is needed to fully validate the clinical usefulness of this novel integrated system.~      In this 3-year prospective study, the investigators will take the advantages of integrated~     PET/MRI scanner with diffusion-weighted MRI (DWI) and dynamic contrast-enhanced perfusion~     weighted MRI (DCE-PWI) to evaluate our 160 patients with oropharyngeal SCC subjected to~     chemoradiation. Non-contrast chest CT will also be performed on the same day. The~     investigators aim to (1) determine whole-body staging/restaging accurately, (2) predict~     treatment response and prognosis, and (3) to determine necessity of noncontrast chest CT. The~     investigators expect that this project will offer the validation of usefulness of integrated~     PET/MRI in tumor staging/restaging of oropharyngeal SCC and resultant clinical impact. The~     role of noncontrast chest in the workup with our PET/MRI protocol can be defined. It will~     also provide evidence about how and to what extent the various simultaneously acquired MRI~     and PET functional parameters can help prediction of treatment response and prognosis, which~     are important in timely modification of treatment regimen.~   "
30809|NCT03163784|"~     SHIFT is a randomized, longitudinal, prospective, blinded, three-arm study to determine the~     safety and tolerability of Fecal Microbiota Transplant (FMT) in HIV-infected participants on~     stable antiretroviral therapy (ART).~   "
30810|NCT03163771|"~     The principal aim of the study is to avoid the diagnostic wanderings of patients suffering~     from a peroxisomal disorder. For this purpose, a new diagnostic strategy is proposed. It~     rests on functional metabolic explorations and gene studies directly connected to a~     first-line enlarged physico-chemical detection of metabolites from peroxisomal origin in~     clinically suspect patients.~   "
30811|NCT03163758|"~     The study aimed to figure out brain structural and functional reorganization evidence after~     repetitive transcranial magnetic stimulation through the method of neuroimaging brain network~     analysis, such as resting-state functional magnetic resonance imaging and diffusion tensor~     imaging.~   "
30812|NCT03163745|"~     Spontaneous bacterial peritonitis is defined as the presence of an infection in a previously~     sterile ascites in the absence of an intra-abdominal source of infection or malignancy .~      The variants of Spontaneous bacterial peritonitis includes - (i) Classic Spontaneous~     bacterial peritonitis: -ascitic fluid polymorphonuclear leukocyte counts more than 250/mm3~     and positive culture. (ii) Culture negative neutrocytic ascitis but the ascitic fluid~     polymorphonuclear leukocyte counts more than 250/mm3 and (iii) Bacterascites: - a culture~     positive ascitic fluid but the polymorphonuclear leukocyte counts less than 250/mm3~   "
30813|NCT03163732|"~     The PROFILER 02 program is a multicenter, randomized, prospective cohort study aiming to~     compare the clinical relevance of a large Next-generation sequencing (NGS) panel~     (FondationOne or FOne panel) versus a limited NGS panel (CONTROL or CTL panel) in patients~     with advanced solid tumors.~      This study will allow adapting the therapeutic management of these patients, if needed, by~     giving them recommended therapies (commercialized or in ongoing clinical trials), based on~     the recommendations of the Molecular Tumor Board (MTB).~   "
30814|NCT03163719|"~     Defining the origin of a seizure remains a difficult diagnosis. The presence of witness is~     not systematic, the clinical examination can be little contributory, and the delay~     recommended by the FSN is often surpassed for the realization of Creatine kinase (4h). In the~     event of a suspected seizure, an initial blood test with Creatine kinase and Lactates is~     often done on admission of the patient in other words before the 4hours delay.~      It seems interesting to harmonize the practices, to limit the patient wait in the emergencies~     for a deferred dosage of CK at 4 hours from the seizure and to identify an early biological~     marker.~      Objectives:~      To evaluate the value of blood CK and Lactate dosage in emergency procedures in the diagnosis~     of generalized seizures.~   "
30815|NCT03163706|"~     The main objective of this study is to assess whether attention deficits and executive~     functions in patients with schizophrenia are general (semantic and response conflict) or~     specific (semantic or response conflict).~   "
30816|NCT03163693|"~     The purpose of this study is to observe the impact of dexmedetomidine on Cardiac Troponin I~     and Glycogen Phosphorylase Isoenzyme BB in patients undergoing off-pump coronary artery~     bypass Grafting.~   "
30817|NCT03163680|"~     Determining the efficacy of low dose of PPI in management acute peptic ulcer bleeding~   "
30818|NCT03163667|"~     Phase 2 Study Comparing CB-839 in Combination with Everolimus (CBE) vs. Placebo with~     Everolimus (PboE) in Patients with Advanced or Metastatic RCC~   "
30819|NCT03163654|"~     The aim of this study was to assess the clinical efficacy of the acellular porcine derived~     collagen matrix (PADM) in comparison with connective tissue graft (SCTG ) in the treatment of~     multiple adjacent gingival recessions (MAGR). The primary objectives of the study were to~     evaluate mean and complete roots coverage. Additionally, the secondary objective was to~     evaluate and compare the clinical effectiveness of PADM and SCTG for the treatment of MAGR~     defects applying modified coronally advanced tunnel technique (MCAT).~   "
30820|NCT03163641|"~     This is a prospective, randomized (Reading Center), masked, controlled study in up to 45~     subjects who have undergone bilateral PRK with epithelial removal using alcohol in a 9.0 mm~     well or trephine at the time of surgery to ensure consistency of the size of the ablation~     area.~   "
30821|NCT03163628|"~     ANTOINE is a prospective trial which aims to assess diagnostic performance of 7 biomarkers~     for the diagnosis of severe bacterial infections (SBI) in children aged from 7 days to 36~     months.~      Fever is a frequent cause of consultation in pediatric emergency departments. Clinical~     diagnostic tools are rare and discrimination between severe bacterial infection and viral~     infection is difficult to confidently state. The prevalence of severe bacterial infections~     (IBS) varies from 10 to 25% according to the studies. Biological markers such as~     procalcitonin (PCT) and C-reactive protein (CRP) are commonly used in clinical practice.~     These markers have bacterial specificity but share a wide range of values with viral~     infections and do not make it possible to exclude or to confirm definitively the diagnosis of~     IBS. The use of new markers to improve the diagnosis of bacterial and viral infections is~     increasingly studied in adults. The diagnostic value of these new markers has been~     demonstrated by associating their dosage with that of CRP for example. This is the case for~     IP-10, TRAIL or MxA. However, very few pediatric studies have been carried out to date on~     these new biomarkers. However, in pediatrics, these diagnostic tools based on the combination~     of biomarkers to discriminate against viral and bacterial infections could be a major help in~     the suspicions of IBS. 7 biomarkers were selected to be evaluated in this study. This study~     is designed to determine the best biomarkers combination for the SBI diagnosis on a cohort of~     800 patients.~   "
30822|NCT03163615|"~     The purpose of this study is to evaluate the effect of Tibet Rhodiola Capsule on hypoxia and~     the cardiovascular risk factors in patients with mild to moderate OSA.~   "
30823|NCT03163602|"~     The aim of this randomized controlled study is to evaluate the outcome of surgical treatment~     of peri-implantitis with and without the use of a bone substitute graft covered by a collagen~     membrane. There will be a follow up period of 12 months. Outcome measures will include~     assessments of inflammation, probing depth, recession, radiological parameters and PROMs.~   "
30824|NCT03163589|"~     Perinatal hypoxic-ischaemic encephalopathy occurs in one to three infants per 1000 term~     births, and up to 12 000 infants are affected each year in the united state of America.~     Hypoxic ischemic encephalopathy is not preventable in most cases, and therapies are limited.~     Hypothermia improves outcomes and is the current standard of care. Yet clinical trials~     suggest that 44% to 53% of infants who receive hypothermia will die or suffer moderate to~     severe neurological disability. Therefore, novel neuroprotective therapies are urgently~     needed to further reduce the rate and severity of neurodevelopmental disabilities resulting~     from hypoxic ischemic encephalopathy.~      Erythropoietin is a novel neuroprotective agent, with remarkable neuroprotective and~     neuroregenerative effects in animals. Rodent and primate models of neonatal brain injury~     support the safety and efficacy of multiple erythropoietin doses for improving histological~     and functional outcomes after hypoxia-ischaemia.~   "
30825|NCT03163576|"~     Hyperphosphatemia is a common complication of end-stage renal disease and particularly~     affects haemodialysis patients. Elevated serum phosphorus contributes to the development of~     secondary hyperparathyroidism, Mineral bone disorders,metastatic calcifications and calcific~     uremic arteriolopathy. There is a significant association between hyperphosphatemia and~     increased morbidity and mortality in end stage renal disease patients including~     cardiovascular morbidity and mortality ,also it's associated with hospitalization of~     haemodialysis patients.~   "
30826|NCT03163563|"~     The purpose of the study is to measure patient- temperature in the perioperative period of~     patients undergoing plastic surgery in an ambulatory surgical unit. This study will evaluate~     if active warming with self-warming blanket (Easywarm®) is as effective as active warming~     with forced-air blanket (BairHugger®). Second the study will evaluate if one or both methods~     is effective in preventing perioperative hypothermia.~   "
30831|NCT03163498|"~     Introduction: Sleep disturbances may contribute to impairments in mood, occupational and~     intellectual performance, and social relationships, as well as being associated with~     cardiovascular diseases, such as arterial hypertension. Sedentary lifestyle has often been~     associated with poor sleep quality and hypertension; regular exercise has been studied as a~     coadjuvant therapy for hypertension and/or for some sleep disorders. Objective: To compare~     sleep pattern of active and inactive patients with arterial hypertension, as well as to~     evaluate complaints of depression and anxiety, and the mood profile. Material and Methods:~     Polysomnography, Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale will be used to~     assess the sleep pattern. Depression will be assessed by the Beck Depression Inventory (BDI),~     Beck Anxiety Inventory (BAI) anxiety, and mood pattern by the State of Mood Profile (POMS).~     The level of physical activity will be recorded by the number of steps taken (pedometer).~     Participating in the study will be 60 hypertension patients (ACTIVE, n=30; INACTIVE, n=30).~     Hypothesis: Active hypertensive patients better quality of sleep, better mood profile, and~     fewer complaints of depression and anxiety when compared to physically inactive hypertensive~     patients.~   "
30832|NCT03163485|"~     This clinical trial evaluates the safety and diagnostic performance of a newly developed~     combined catheter that will be implanted into the brain of patients with severe brain injury~     for short time (up to 28 days) monitoring of the electric activity and the metabolism of~     brain tissue at risk. Ten patients will be monitored with the new device and seven patients~     will be monitored by intracerebral probes according to standard treatment.~   "
30833|NCT03163472|"~     Axillary brachial plexus block is an safe, effective and widely used technique for providing~     surgical anesthesia at and below the elbow. Inadvertent intraneural and intravascular~     injections are the only significant risks. Traditionally, greater volumes of local~     anaesthetic have been administered to achieve successful axillary brachial plexus block, but~     recent studies have demonstrated that this can be achieved with even very low volumes of 2-4~     mL lidocaine 1.5% per nerve or ultra low volume of 1 mL lidocaine 2% per nerve.~      Administration of 30mL (vs 10 mL) lidocaine 2% with epinephrine 1:200 000 prolongs the~     sensory and motor block duration of ultrasound guided axillary brachial plexus block for~     elective upper limb surgical procedures.~      Primary Outcome:~      The primary outcome will be the overall duration of sensory block.~      Secondary Outcomes:~      Duration of motor block Time to onset of the block. The quality of block intra operatively~     Time to first request of postoperative opioid analgesia. Total opioid consumption at 24~     hours. The incidence of adverse effects perioperatively: nausea, dizziness, tinnitus,~     vomiting, convulsions or arrythmia.~   "
30834|NCT03163459|"~     To determine the efficacy and safety of short-duration intra-artery selective brain cooling~     in addition to mechanical thrombectomy in patients with acute ischemic stroke.~   "
30835|NCT03163446|"~     The purpose of this study is to evaluate the safety, tolerability, efficacy and~     pharmacokinetics (PK) of CF-301 in addition to background standard of care (SOC)~     antibacterial therapy for the treatment of Staphylococcus aureus (S. aureus) bloodstream~     infections (bacteremia), including endocarditis in adults. Patients will be randomized to~     receive a single intravenous dose of CF-301 or placebo in addition to SOC antibacterial~     therapy. Patients will be prescribed standard of care antibiotics selected by the~     investigators based on their professional experience, practice guidelines and local~     antibiotic susceptibility information for the treatment of S. aureus bacteremia.~      CF-301 is a lysin and member of a new class of targeted protein-based antimicrobials that has~     demonstrated activity against S. aureus in laboratory (in vitro) and animal studies, alone~     and in addition to conventional antibiotics.~   "
30836|NCT03163433|"~     The aim of the study is to examine the potentials of involving patients with metastatic~     melanoma in their own care planning through systematic use of patient-reported outcome~     measures (PROM). Furthermore, to examine the outcome of health-related quality of life,~     self-efficacy and impact on the patient-physician interaction.~      Patients (N=282) will be included from three highly specialized hospitals in Denmark. At one~     hospital patients will complete PROM before each consultation during a year (intervention~     group). At the two other hospitals patients will not complete PROM (control group). In~     addition to baseline, measurements will take place after three, six and 12 months. The~     project is organized and executed with patient involvement in the research process.~   "
30837|NCT03163420|"~     The aim of this clinical trial is to evaluate the effect of pre-operative administration of~     diclofenac potassium on the efficacy of inferior alveolar nerve block on using 2% mepivacaine~     anaesthetic agent in patients with symptomatic irreversible pulpitis.~   "
30838|NCT03163407|"~     Prospective, randomized study, including full term parturients scheduled for caesarean~     section under spinal anesthesia. Spinal anesthesia was performed in sitting position with a~     25 G spinal needle and all patients received 15 ml/kg of crystalloid intravenously during the~     spinal block. Baseline hemodynamics: heart rate, systolic and diastolic blood pressure were~     recorded before spinal anesthesia and intraoperatively. Postspinal hypotension, defined as~     decrease of Systolic blood pressure>20% from the baseline value, was managed using Ephedrine~     increments 6 mg/3min in patients of GE group or by 5 mcg Norepinephrine/3min for the patients~     of GN group. Intraoperative hemodynamic data of the 2 groups were compared.~   "
30852|NCT03163225|"~     The purpose of this research study is to determine whether there are things that~     Intermountain can do to break down barriers to helping patients see their primary doctors or~     other outpatient clinics. To do this we will develop and test a classification scheme to help~     us understand how we might reduce some avoidable emergency department and InstaCare visits.~   "
30853|NCT03163212|"~     This study will examine the safety and tolerability of supplementation with bovine~     lactoferrin with fructo-oligosaccharide a simple sugar in very low birth weight infants.~     Lactoferrin is a major whey protein in mother's milk and plays a role in promoting a mature~     and healthy gut. It also has antimicrobial and immunomodulation activities.~   "
30880|NCT03162848|"~     The purpose of this pilot RCT study is to evaluate the acceptability and feasibility of a~     SystemCHANGE™ intervention to improve medication adherence in older adults with heart~     failure. The intervention focuses on changing the individual's environment by incorporating~     medication taking into existing routines using small experiments with feedback, and receiving~     support from people who impact routines.~   "
30839|NCT03163394|"~     Urinary tract infections (UTIs) are a common cause of bacteremia and serious bacterial~     infections in young children (2-24 months of age). Because these children are usually unable~     to say what symptoms they are experiencing, UTIs are diagnosed through testing. Current~     testing of urine samples require a catheter or suprapubic aspiration performed for urine~     collection for infections markers to be reliable. Bag specimens often have varying results~     that can be poor in sensitivity and specificity depending on what component of the urine test~     one is looking at. Catheter and aspiration testing can be anxiety-provoking to parents, be~     painful for patients and even introduce bacteria into the bladder. An antimicrobial peptide~     called alpha human defensin-5 (HD5) is produced by the uroepithelium in response to~     infection. HD5 has been studied in the urine and does increase in actual UTIs. This study~     will look at children 1 to 24 months of age and again study levels of HD5 in culture positive~     UTIs versus urine negative for UTI. This study will also determine if collection method~     alters HD5 levels. We will measure HD5 levels in the urine from a bag specimen and a catheter~     specimen in the same patient.~      Our primary objective is to determine the sensitivity and specificity of HD5 measured in~     urine collected by bag and catheter in the same patient for the diagnosis of UTI in children~     between the age 1 to 24 months presenting with febrile illness and suspected UTI.~   "
30840|NCT03163381|"~     Apatinib second line treatment for Advanced osteosarcoma and soft tissue sarcomas ,openting~     ,single center, one-armed clinical study.~   "
30841|NCT03163368|"~     The purpose of this study is to study if giving radiation to a brain tumor (a procedure~     called radiosurgery) before neurosurgery (surgery to remove the tumor) will help to keep~     brain tissue healthy, while possibly eliminating the need to return for radiation once a~     patient has healed from neurosurgery. This study will also seek the best radiation dose on a~     brain tumor based on how well the radiation therapy works and asses the side-effects.~   "
30842|NCT03163355|"~     The texture of the pureed diet is likely to be most useful factor predictive of the~     prevention of aspiration pneumonia. However, it has not been previously reported what kinds~     of texture of the pureed diet can prevent aspiration pneumonia. Using endoscopic swallowing~     evaluation, we attempt to compare two kinds of the pureed diets to choose the better texture~     of pureed diets in elderly patients with severe dysphagia.~   "
30843|NCT03163342|"~     This is an open-label, single administration dose study in adult healthy male and female~     subjects. After qualifying for the study, subjects will receive a single intramuscular~     injection of the FDA approved 2016-2017 quadrivalent influenza vaccine.~   "
30844|NCT03163329|"~     Previous trials have shown that TAVR was a noninferior alternative to surgery in patients~     with severe aortic stenosis at intermediate surgical risk. However, patients with congenital~     bicuspid valve have been excluded in those trials. The purpose of this trial is to determine~     the safety and effectiveness of TAVR in intermediate-risk patients with bicuspid aortic valve~     stenosis.~   "
30845|NCT03163316|"~     Breast cancer is the most common cancer among women worldwide.The main cause of cancer~     related death is the invasion and metastasis. The usual site of spread outside the breast is~     to lymph nodes in the axilla.~   "
30846|NCT03163303|"~     This trial will test the efficacy of a 3-month intervention on Facebook targeting tobacco use~     and heavy episodic drinking against a 3-month Facebook intervention targeting tobacco use.~     Both groups will be offered a nicotine patch starter kit. The primary outcome is verified~     7-day point prevalence abstinence from smoking at 3, 6, and 12 months.~   "
30847|NCT03163290|"~     Patellofemoral Pain (PFP) is one of the most common disorders that affecting the physically~     active population, and its incidence is higher among women. Despite the high incidence, the~     etiologies of this painful syndrome are still unclear. Research has verified the influence of~     hip stabilizers on knee injurie and has demonstrated a deficit of strength of the hip lateral~     rotator, abductors and extensors muscles in patients with PFP. The aim of this study is to~     compare the effectiveness of strengthening the Posterolateral Hip Complex with the~     Anteromedial Hip Complex associated with quadriceps strengthening for pain reduction and~     improvement of functional capacity in patients with PFP.~   "
30848|NCT03163277|"~     Neurocognitive disorders are still highly prevalent in the HAART era; despite a dramatic~     reduction in dementia cases, 15-50% of patients may develop mild or asymptomatic~     neurocognitive disorders (HIV-associated neurocognitive disorders, HAND).~      Among other hypothesis neurotoxicity of antiretrovirals has been postulated but its impact is~     unknown.~      Our hypothesis is that using drugs with reduced in vitro neurotoxicity may improve cognition~     in HIV-positive patients withHAND.~      76 patients with HAND will be randomized to either continue their treatment or switch to~     emtricitabine, darunavir/cobicistat, maraviroc. Patients will be re-tested 6 months later.~   "
30849|NCT03163264|"~     The PAL intervention uses a new software tool delivered on tablets to facilitate 5As-based~     weight management counseling with a health coach and the VA PACT healthcare team to promote~     goal-setting, behavior change, and weight loss in the primary care (PC) setting. The PAL~     intervention also includes 10-12 health-coaching calls to the patient over 12 months.~      As part of a cluster-randomized controlled study, the investigators will randomize 17 PACT~     teams at the Brooklyn VA to receive either the PAL Intervention or an Enhanced Usual Care~     control. The primary aim of the study is to explore differences in feasibility,~     acceptability, and intermediate, behavioral, and weight loss outcomes at 6 and 12 months of~     520 patients recruited from the randomized PACTs.~      Objective:~      1) Explore the feasibility and impact of this intervention on intermediate, behavioral, and~     weight loss outcomes at 6 and 12 months post-intervention when compared to enhanced usual~     care.~   "
30850|NCT03163251|"~     This study evaluates the effect of peer facilitated monthly small group topic-based small~     group discussions on various themes common to physician training that pertain to aspects of~     humanism on rates of burnout. Attendance to these sessions and completion of the surveys is~     voluntary.~   "
30851|NCT03163238|"~     Cardiopulmonary bypass-assisted surgery initiates a systemic inflammatory response induced by~     extrinsic (e.g. anesthesia, contact activation within the extracorporeal circuit,~     endotoxemia) and intrinsic (e.g. tissue damage, endothelial cell activation,~     ischemia-reperfusion injury of myocardium) factors. This may either be mild or lead to a more~     severe clinical condition. Inflammation after pediatric open heart surgery is a parameter~     affecting also duration of mechanical ventilatory support. Dexmedetomidine use was associated~     with a reduced increase in plasma IL-1, IL-6, TNF-a, and INF-g levels~   "
30854|NCT03163199|"~     Primary objective: To document change in translesional pressure gradients (TLPGs) and ratios~     (fractional flow reserve) using the NAVVUS RXi catheter following endovascular treatment for~     symptomatic lower extremity peripheral arterial disease.~      Secondary objectives:~        -  Evaluation of correlation of the ABI and TBI and TLPGs at baseline and following~          endovascular therapy~        -  Evaluation of the correlation between the change in WIQ, TCOMs, wound size and change in~          TLPGS~        -  Evaluation of correlation between lesion severity by QVA (MLD, % diameter stenosis) and~          TLPGs~        -  Evaluation of baseline MLA, MLD, plaque burden by intravascular ultrasound (optional)~          and TLPGs~   "
30855|NCT03163186|"~     To evaluate the safety, advantages, and appropriateness of performing transarterial hepatic~     emobolization of liver cancer via arterial access from the radial artery versus conventional~     transfemoral arterial access. The procedures that will be followed utilizing arterial access~     include transarterial chemoembolization (TACE), specifically performed for hepatocellular~     carcinoma, and transarterial embolization (TAE) which is performed for types of liver tumors~     such as carcinoid tumors or liver metastases.~   "
30856|NCT03163173|"~     GC4419 is being studied to treat and prevent oral mucositis (painful inflammation) in cancer~     patients who receive radiation and chemotherapy.~      In this study, GC4419 will be mixed with a small amount of radioactive material in order to~     find out how much study drug is in the blood and to see how the drug is processed and~     eliminated from the body. The safety and how subjects tolerate the study drug will also be~     studied.~   "
30857|NCT03163160|"~     Pelvic floor muscle physical therapy is recommended in clinical guidelines for women~     dyspareunia and pelvic pain. This study compare pelvic floor manual therapy and intratissue~     percutaneous electrolysis (EPI) technique in the treatment of pelvic pain in women with~     dyspareunia. Half of participants will receive pelvic floor manual therapy while the other~     half will receive intratissue percutaneous electrolysis technique.~   "
30858|NCT03163147|"~     Immune thrombocytopenia (ITP) is an autoimmune disorder characterized by low platelet count~     (i.e less than 100.000) . In ITP, platelet surface membrane proteins become antigenic for~     unknown reasons , leading to stimulation of the immune system , autoantibody production, and~     platelet destruction In recent years ,the list of etiologies of ITP has been steadily~     increasing, so the term idiopathic is becoming obsolete, increasingly replaced by~     immuneTP .~      Treatment of ITP may be conceptually divided into rescue therapy and maintenance therapy .~     the terminology of corticosteroid-dependence means The need for ongoing or repeated doses~     administration of corticosteroids for at least 2 months to maintain a platelet count at or~     above 30 _ 109/L and/or to avoid bleeding. So, patients with corticosteroid dependence are~     considered non responders~   "
30859|NCT03163134|"~     The overall purpose of this study was to assess the necessity of lumbar drain placement after~     endoscopic endonasal approach (EEA) surgery in reducing cerebrospinal fluid (CSF) leak~     postoperatively and promote a standardization of its use.~   "
30860|NCT03163121|"~     This is a first-in-human, randomized clinical trial of PfSPZ-GA1 Vaccine (genetically~     attenuated PfSPZ) in healthy malaria-naïve adult volunteers. This Phase 1 trial is divided~     into two stages, Stage A and B. Stage A is an open label, single center, dose escalation~     study in 19 volunteers. Stage B is a multi-center, double blind, randomized,~     placebo-controlled trial in 48 volunteers. The primary objective of this study is to~     determine the safety and tolerability of direct venous inoculation (DVI) of PfSPZ-GA1 Vaccine~     in healthy adults.~   "
30861|NCT03163108|"~     Two-center, randomised controlled, cross-over clinical trial in preterm infants born at~     gestational age below 34+1/7 weeks receiving supplemental oxygen and respiratory support~     (Continous positive airway pressure (CPAP) or Non-invasive Ventilation (NIV) or Invasive~     Ventilation (IV)). Routine manual control (RMC) of the fraction of inspired oxygen (FiO2)~     will be tested against RMC supported by closed-loop automatic control (CLAC) with~     slow-algorithm and RMC supported by CLAC with fast-algorithm.~      The primary hypothesis is, that the use of the faster algorithm results in more time within~     arterial oxygen saturation (SpO2) target range compared to RMC only. The a-priori subordinate~     hypothesis is, that the faster algorithm is equally effective as the slower algorithm to~     maintain the SpO2 in the target range.~   "
30862|NCT03163095|"~     This is a prospective randomized clinical study. The study will comprise the randomized~     decision to either A) primarily close the fascia after laparotomy for intra-abdominal~     infection (CLOSED); or B) leave the fascia open after laparotomy and apply a temporary~     abdominal closure (TAC) device (OPEN) with a vacuum drain.~      Although debatable, both procedures (CLOSED or OPEN abdomen) are acceptable based on current~     suggested standard of care. Thus, high quality data to direct clinical decision making in~     this highly lethal condition is urgently required.~   "
30863|NCT03163082|"~     The investigators are interested in typical couple interactions and health behaviors. In~     particular, the investigators are interested in different ways that each partner in a coupled~     relationship reacts to and understand each other's behavior, and in their health behaviors.~   "
30864|NCT03163069|"~     This double-blind randomized controlled clinical trial aimed to investigate the effect of~     whitening dentifrices on the clinical efficiency of in-office tooth bleaching procedures.~   "
30865|NCT03163056|"~     The present research project aims to develop an innovative and empirically validated~     intervention protocol for smoking cessation among patients with depressive symptoms. For this~     purpose, two smoking cessation treatments tailored for managing depression will be compared~     with a standard smoking cessation treatment. Participants will be assigned to one of the~     following three treatment conditions: 1) Cognitive-behavioral treatment for smoking cessation~     (CBT); 2) CBT plus Behavioral Activation (BA); 3) CBT+BA+ Contingency Management (CM).~      The main goals are:~      1. To assess abstinence rates in each of the above-mentioned treatment conditions conditions~     at short and long-term follow-ups: post-treatment, once during the first three months, and at~     at six after post-treatment.~      1. To assess the effectiveness (relapse rate) of each treatment condition at short and~     long-term follow-ups: post-treatment, once during the first three months,and at six after~     post-treatment.~      3. To analyze efficiency (cost-efficacy) and feasibility of the treatments to a community~     setting.~      4. To analyze the moderating effect of individual variables over treatment outcomes. In~     particular, moderating variables will be: sociodemographic characteristics, severity of~     nicotine dependence, severity of depressive symptomatology and impulsivity.~      The study hypothesis are:~      1-Adding a voucher-based CM component to CBT+BA will enhance abstinence rates and decrease~     both short and long-term relapse rates.~      2. Providing smoking cessation treatments that include a mood management component (BA or~     BA+CM) will have a positive impact in ameliorating depression.~      3. Certain individual variables (e.g., gender, nicotine dependence and depression severity~     and impulsivity) will have a moderating effect on treatment outcomes.~      4. Both CBT+BA and CBT+BA+CM will prove cost-effectiveness and thus may be generalized to a~     clinical and community context.~   "
30866|NCT03163043|"~     Nutritional requirements for dietary amino acids in children have traditionally been~     determined utilizing the nitrogen balance technique, which is prone to underestimating~     protein requirements. As a result, there is a need to re-evaluate recommendations in order to~     characterize how dietary amino acid needs may be modulated by physical activity in healthy,~     active children. The purpose of this study is to measure the protein requirement in children~     (boys and girls) using the IAAO technique in the presence of a variable intensity exercise~     stimulus. It is hypothesized that the present study will deem current amino acid requirements~     to be underestimates of appropriate amino acid requirements for this population.~   "
30867|NCT03163030|"~     The ANTHEM-HFpEF Study is designed to demonstrate the safety and efficacy of vagus nerve~     stimulation (VNS) with the Cyberonics VNS Therapy System for the treatment of subjects with~     symptomatic heart failure with preserved and mid-range ejection fraction.~   "
30868|NCT03163017|"~     The purpose of this study is to determine if use of new imaging technology termed 3D~     fluoroscopy will lead the surgeon to change the position of the fractured bones to a more~     accurate position.~   "
30869|NCT03163004|"~     Since sedentary time is related to various health outcomes and is already highly prevalent in~     childhood and adolescence, effective strategies are needed to tackle this health problem.~     Children and adolescents spend the majority of the day in a classroom while sitting at a~     desk. Therefore, the classroom is an important setting for implementing specific strategies~     to reduce sedentary time.~      One of the strategies that gained more attention during the past years is replacing~     traditional desks and chairs with standing desks.~      This project evaluates the implementation of standing desks in primary and secondary schools~     via a clustered randomized controlled trial using an intervention and control condition.~     Effects on sedentary time during in class, sedentary activities during leisure time, breaks~     in sedentary time, and related determinants (secondary outcomes) are evaluated.~      Next to effect evaluation, it is also equally important to evaluate how teachers and pupils~     perceive this change in the classroom environment. Both groups need to be positive in order~     to obtain the adoption and sustainability. Therefore, focus groups with pupils and interviews~     with teachers are conducted, with a specific focus on the perceived barriers. Moreover, the~     process evaluation is conducted quantitatively as well by using questionnaires in pupils and~     teachers.~      The project results will lead to recommendations on how to broadly implement standing desks~     into primary and secondary schools.~   "
30870|NCT03162991|"~     Overview- In this study, overweight or obese, sedentary participants (age=35-55 years, n=20)~     will be randomized to a 12-week control period or an aerobic exercise intervention. Those~     randomized into the control group will then complete the exercise intervention subsequently.~     The planned energy expenditure per week of exercise will be 10-12 kilocalories per kilogram~     of body weight per week. Participants will complete three non-consecutive exercise sessions~     per week. Body weight, resting metabolic rate via indirect calorimetry, peak oxygen~     consumption (VO2peak) through graded exercise testing, fasting blood samples, CGM, sleep and~     dietary habits via self-report, and physical activity monitoring will be completed at prior~     to and following the aerobic exercise intervention.~   "
30871|NCT03162978|"~     The purpose of this study is to research the effects of exercising at high intensities for~     short periods of time on exercise tolerance and motivation.~   "
30872|NCT03162965|"~     The investigators propose to improve HIV prevention and care through expanding HIV testing~     options to include self-testing for young women, their peers and their sex partners, and by~     facilitating linkage to care.~   "
30873|NCT03162952|"~     The RAND approach to appropriateness makes it feasible to take the best of what is known from~     research and apply it—using the expertise of experienced clinicians—over the wide range of~     patients and presentations seen in real-world clinical practice. The major limitation of the~     RAND approach, however, is that it still utilizes a limited definition of appropriateness;~     one that relies heavily on safety, efficacy and effectiveness. Until now the RAND method has~     not included patient preferences or resource utilization effectiveness. These are both~     serious absences. In the past decade we have seen an evolution in outcome measures from~     clinician based objective measures to patient-centered and subjective measures. The~     development of Patient Based Outcome Assessments (PBOA); Patient Reported Outcomes~     Measurement Information System (PROMIS) and the recent establishment of Patient-Centered~     Outcomes Research Institute (PCORI) all contest to the growing importance of the patient's~     perspective in determining outcomes and therefore also appropriateness. In the Center, we~     propose to advance appropriateness methods by adding three additional dimensions to the RAND~     appropriateness methods: patient outcomes, patient preferences and cost~   "
30874|NCT03162926|"~     The purpose of this trial is to test if VC-02™ combination product can be implanted~     subcutaneously in subjects with Type 1 Diabetes and maintained safely for up to four (4)~     months.~   "
30875|NCT03162913|"~     This study is being conducted to assess the effect of dietary strawberry supplementation on~     cognition and mobility in obese middle-aged and older adults. It is hypothesized that plant~     compounds, present in strawberries, may improve cognition and mobility.~   "
30876|NCT03162900|"~     This is a Thorough QT study intended to estimate the effect of glasdegib at therapeutic~     exposure and at supra-therapeutic exposure on cardiac repolarization in healthy subjects.~     This is a randomized, double blind, positive and placebo controlled study with a 6 day~     washout between successive periods.~   "
30877|NCT03162887|"~     This pilot clinical trial studies how well an educational module and decision counseling~     program works in increasing mammography screening rates in formerly homeless women with~     serious mental illness. An educational module and decision counseling program may be an~     effective tool and have the potential to help with early detection and treatment.~   "
30878|NCT03162874|"~     This will be a double-blind, randomised, placebo-controlled parallel-arm phase II proof of~     concept in subjects with PD treated with a stable dose of levodopa who are experiencing both~     end-of-dose wearing off and Levodopa-Induced Dyskinesia (LID)~   "
30879|NCT03162861|"~     To assume that lumbar plexus-sciatic nerve block combined with sevoflurane can effectively~     diminish the incidence of cognitive dysfunction in elderly patients after hip arthroplasty.~   "
43037|NCT03003442|"~     Investigation of the acute and chronic effects of Supradyn® Energy 3RDA on subjective ratings~     of 'fatigue/stress', substrate metabolism and blood biomarkers of recovery, as a consequence~     of exercise and metabolically demanding cognitive tasks.~   "
30881|NCT03162835|"~     The scientific objective of this research implies developing and examining the clinimetric~     properties of the Dutch Pediatric Neurophysiology of Pain Questionnaire (PedNPQ) in healthy~     children.~      A total study sample of 60 healthy children (30 from 2nd and 3rd primary school) will be~     included to measure test-retest reliability of the Pediatric Neurophysiology of Pain~     Questionnaire (PedNPQ). Children will be asked to fill in the questionnaire twice, with a~     time interval of 48 hours (assessment T0 and T1).~      In order to assess concurrent validity of the PedNPQ, 30 children (15 from 2nd and 3rd~     primary school) as well as their parent will receive a pediatric Pain Neuroscience Education~     (PNE) session. It is hypothesized that if the developed PedNPQ is valid, children who~     received PNE will perform better than children receiving no PNE.~      To reduce the participant's workload, all assessments will be done immediately after the~     school hours or during recreation, in the primary school of the participant.~   "
30882|NCT03162822|"~     Caregivers and their child are being asked to participate because the investigators are~     interested in typical caregiver-child interactions and health behaviors. In particular, the~     investigators are interested in different ways that caregivers react to and understand their~     young children's behavior, and their health behaviors.~   "
30883|NCT03162809|"~     Salivary diagnostic testing is emerging as a less invasive, inexpensive alternative to serum~     analyte measurements with proven diagnostic accuracy in clinical settings. This study aims to~     continue analyzing aspects of the performance of salivary hormone competitive immunoassays~     for monitoring patient's reproductive hormone profiles in the reproductive cycle. Hormone~     levels will be monitored during treatment cycles for infertility.~   "
30884|NCT03162796|"~     The primary purpose of this study is to evaluate the efficacy of guselkumab treatment in~     participants with active Psoriatic Arthritis (PsA) by assessing the reduction in signs and~     symptoms of PsA.~   "
30885|NCT03162783|"~     The objective of this study is to evaluate the safety, tolerability, and pharmacodynamic~     activity of ADX-102 Ophthalmic Solutions and ADX-102 Ophthalmic Lipid Solution in subjects~     with dry eye syndrome.~   "
30886|NCT03162770|"~     This protocol of meditation is based on mindfulness program proposes to train meditation~     during the hemodialysis session. The investigators hypothesize that this program offered~     during hemodialysis session may promote well-being, reduce symptoms of stress and depression~     reported by the patients, which ultimately may improve biochemical parameters resulting from~     better adherence to treatment. Objectives: To evaluate the effects of mindfulness meditation~     practice in patients on chronic hemodialysis, in order to verify if this training can improve~     symptoms of depression, stress, quality of life and sleep disturbances. Methods: fifty~     patients will be separated in two groups, twenty five each group, half of them in the control~     group (CG) and the other half to the intervention group (IG). The patients will be evaluated~     pre- and pos-protocol.~   "
30887|NCT03162757|"~     The aim of this pilot study is to establish the success rate of catheterization of the lower~     jugular vein and the subclavian vein under ultrasound guidance in real time. The purpose is~     to compare the two techniques and to determine the best design for a full study (superiority,~     non-inferiority). This is a 2-arm randomized control study. The randomization ensures the~     comparability of the groups and allows evaluation of the feasibility and potential bias for~     further comparative studies.~   "
30888|NCT03162744|"~     Suicidal intentionality is generally stronger among the elderly, suicidal acts are more~     violent and are combined with a greater physical fragility. The suicide of an older adult is~     a situation that often leads to helplessness feelings.~      Analysis of the literature reveals two types of major interventions in order to reduce~     suicide rate: reducing risk factors and increasing protective factors. Risk factors are well~     documented, particularly from studies using psychological autopsies. However, protective~     factors are much less studied for the elderly. Yet the identification of relevant and~     available protective mechanisms in a suicidal crisis is essential to effectively guide nurses~     and health professionals in therapeutic commitment and intervention.~   "
30889|NCT03162731|"~     This pilot clinical trial studies the side effects of nivolumab, ipilimumab and radiation~     therapy in treating patients with stage IVA-B head and neck cancer. Monoclonal antibodies,~     such as nivolumab and ipilimumab, may interfere with the ability of tumor cells to grow and~     spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.~     Giving nivolumab, ipilimumab, and radiation therapy may work better in treating patients with~     stage IVA-B head and neck cancer.~   "
30890|NCT03162718|"~     The paradigm of pre-operative exercise as a neoadjuvant therapy to reduce morbidity is~     increasingly promoted within general surgery and surgical oncology.~      Patients with lung cancer participating in pre-operative exercise have better aerobic~     capacity and pulmonary function and shorter hospital length-of-stay after surgery.~     Additionally, pre-operative exercise may increase the likelihood of resuming exercise~     post-surgery, thereby accelerating the pace of rehabilitation and recovery.~      In order to translate the research findings into sustainable clinical practice,~     clinician-scientists need to develop pragmatic and effective home-based exercise protocols.~     Wearable fitness devices offer a way to approximate the supervision that occurs in exercise~     research.~      Before the investigators can develop an intervention in which patients receive tailored~     support similar to what occurs with supervised exercise, they need to pilot test the~     monitoring aspect of the wearable fitness device in conjunction with the pre-operative~     exercise program. The investigators propose a mixed methods, 16 single arm feasibility study~     of an unsupervised, pre-operative exercise prescription (uPEP) augmented by a wearable~     fitness device. The proposed study of 30 patients scheduled for lung cancer surgery will~     identify the strengths, weaknesses, and utility of this approach.~   "
30891|NCT03162705|"~     This protocol is to obtain tumor tissues and blood samples from patients with a confirmed~     histological diagnosis of Small cell lung cancer(SCLC) for molecular profiling.~   "
30899|NCT03162601|"~     With new developments that have taken place in the optimization of C-arm computed tomography~     (CACT) image acquisition and reconstruction, CACT image quality will be better than current~     standard-of-care CACT scan techniques used for neurovascular patients referred to~     endovascular treatment or diagnosis. As such, novel acquisition, filtration, artifact~     reduction and reconstruction techniques will be evaluated against the standard-of-care CACT~     approach.~   "
30892|NCT03162692|"~     Preoperative anxiety is often described as an uncomfortable, tense unpleasant mood before~     surgery, an emotional response to a potential challenge or threat to reality. Data show that~     adult patients with preoperative anxiety rate of 30-40%. The main reason for the occurrence~     of patients for surgery, anesthesia and other factors of fear. Preoperative anxiety itself is~     not a mental illness, but studies have confirmed that the occurrence of preoperative anxiety~     and postoperative complications were positively correlated, and the existence of preoperative~     anxiety in patients with conventional postoperative analgesic effect is poor. At present,~     there are still few studies on the relationship between preoperative anxiety and~     postoperative complications and analgesia. At the same time, there is a lack of large sample~     size to study the incidence of preoperative anxiety and its related predictors.~   "
30893|NCT03162679|"~     There is a lack of studies on treatment effect in traumatised refugees. Recent findings~     indicate that emotion regulation deficits play a key role in PTSD also among traumatized~     refugees and highlight the importance and potential directions for the development of an~     emotion regulation training for refugees. In this study, the investigators therefore want to~     examine the effectiveness of a new, transdiagnostic, cultural-sensitive group therapy, which~     systematically teaches specific emotion regulation strategies. Participants will be randomly~     assigned to either the emotion regulation training, delivered in group format or a wait list~     control condition. The study takes place in cooperation with REFUGIO Munich, which is a~     treatment centre specialised in the treatment of traumatised refugees. Clinicians will~     deliver the treatment to traumatized asylum seekers and refugees that report difficulties in~     emotion regulation. The investigators will examine if refugees and asylum seekers in the~     intervention group will show improvements in psychological symptoms, social functioning as~     well as in emotion regulation in comparison to a wait list control group which will receive~     the treatment after the intervention group has completed. The group therapy covers 14~     sessions and has a cognitive-behavioural background. It focuses on conveying strategies to~     cope with intense feelings and the patients should gain a sense of self-efficacy and control~     over their trauma-relevant feelings and symptoms. Qualified interpreters will be used in the~     assessments as well as group therapies.~   "
30894|NCT03162666|"~     This study is a post-market clinical follow-up study. The data collected from this study will~     serve the purpose of confirming safety and performance of the ALTERA™ Expandable implant.~   "
30895|NCT03162653|"~     Neonatal hypoxic-ischemic encephalopathy (HIE) is a major cause of death or long-term~     disability in infants born at term in the western world, affecting about 1-4 per 1.000 life~     births and consequently about 5-20.000 infants per year in Europe.~      Hypothermic treatment became the only established therapy to improve outcome after perinatal~     hypoxic-ischemic insults. Despite hypothermia and neonatal intensive care, 45-50% of affected~     children die or suffer from long-term neurodevelopmental impairment. Additional~     neuroprotective interventions, beside hypothermia, are warranted to further improve their~     outcome.~      Allopurinol is a xanthine oxidase inhibitor and reduces the production of oxygen radicals and~     brain damage in experimental, animal, and early human studies of ischemia and reperfusion.~      This project aims to evaluate the efficacy and safety of allopurinol administered immediately~     after birth to near-term infants with HIE in addition to hypothermic treatment.~   "
30896|NCT03162640|"~     Cannabis smokers having begun prematurely their consumption (before 16 years) present a~     persistent impulsivity much later after have stopped their consumptions. The literature~     highlights that the impulsivity promotes the passage towards a compulsive consumption, and~     the loss of control. To explain this phenomenon, some authors hypothesized that impulsivity~     would lead the subjects to overestimate the duration of events and to choose immediate~     rewards than preferred but delayed rewards. This hypothesis questions the role of the~     temporal anticipation in the impulsive choices. In a first hypothesis, the temporal~     impulsivity could be an endogenous deficit bound to the reward, and would be responsible for~     disorders of the temporal anticipation. In this case, the disorders should be observed~     especially when the subject anticipates a reward. Alternately, a disorder of the temporal~     anticipation could provoke impulsivity, and in this case, would be present with or without~     reward. To separate these hypotheses, we propose to test the capacities of temporal~     anticipation of non-smokers and early smokers of cannabis by means of a behavioral task ~     Hazard function task , which allow to measure the capacity of a subject to anticipate the~     apparition of an event on the basis of a temporal cue. The neuronal correlates will be~     measured by a recording EEG of the wave ' CNV ' (fix a quota for denial of variation) which~     reflects the temporal accumulation and the processes of anticipation.~   "
30897|NCT03162627|"~     This study has 2 phases: Phase 1 (dose escalation) and Phase 2 (dose expansion).~      The goal of Phase 1 of this clinical research study is to find the highest tolerable dose~     combination of selumetinib and olaparib that can be given to patients who have solid tumors~     that are advanced or recurrent (has returned after treatment).~      The goal of Phase 2 is to learn if the highest tolerable dose combination found in Phase 1~     can help to control advanced or recurrent solid tumors.~      The safety of the study drug combination will also be studied in both parts.~      This is an investigational study. Selumetinib is not FDA approved or commercially available.~     It is currently being used for research purposes only. Olaparib is FDA approved and~     commercially available for the treatment of ovarian cancer that has a certain type of genetic~     mutation (change). It is considered investigational to use selumetinib in combination with~     olaparib to treat advanced or recurrent cancer.~      The study doctor can explain how the study drugs are designed to work. Up to 90 participants~     will be enrolled in this study. All will take part at MD Anderson.~   "
30898|NCT03162614|"~     This study is designed to evaluate efficacy, immunogenicity and safety of various dose~     schedules of GSK Biologicals' candidate malaria vaccines RTS,S/AS01B (adult formulation) and~     RTS,S/AS01E (pediatric formulation) in healthy malaria-naïve subjects aged 18-55 years. The~     purpose of this study is to investigate whether changes in dosing schedule are associated~     with increased or equivalent protection, and to evaluate the immune mechanisms associated~     with vaccine efficacy under varying dosing schedules.~   "
30900|NCT03162588|"~     In this study, the investigators aim to evaluate the indirect revascularization outcomes of a~     new combination therapy of multiple burrhole procedure with promotion of arteriogenesis by~     intravenous (IV) erythropoietin (EPO) pretreatment on Moyamoya patients with acute~     neurological presentation, and outline the clinical and vascular factors associated with~     revascularization through the burrholes.~   "
30902|NCT03162562|"~     This is a Phase Ib study to look at the combination of an antibody immunization vaccine~     strategy using oregovomab and an investigational stage immune booster (poly ICLC / Hiltonol),~     both of which have previously been used in combination with other cancer treatments and~     demonstrated to be active in advanced cancer, but which have not previously been used~     together. This study will assess the approach as to whether these two drugs can safely add to~     the response seen with either drug alone, both of which have doses that are based on prior~     studies.~      Subjects with stable disease for whom a 12 week break from therapy for their persistent and~     progressive advanced ovarian cancer is appropriate, who have signed informed consent and for~     whom baseline clinical information is completed, will receive 4 cycles of oregovomab/Hiltonol~     immunization every three weeks (weeks 0, 3, 6, and 9). Blood will be obtained for to look for~     a CA125 specific T cell response at 12 weeks before initiating any additional therapy~     according to the best clinical judgment of the investigator. At week 16 the subjects will~     receive a final dose of the combination of oregovomab/Hiltonol and at week 17 will have an~     additional blood draw for analysis of T-cell response.~   "
30903|NCT03162549|"~     This prospective, non-interventional research registry is designed to study the comparative~     effectiveness and comparative safety of approved treatments for IBD in a cohort of patients~     cared for by gastroenterologists across North America. Secondary objectives include analyzing~     the epidemiology and natural history of the disease, its comorbidities, and current treatment~     practices.~   "
30904|NCT03162536|"~     This Phase 1 dose escalation study will evaluate the safety, pharmacology, and activity of~     ARQ 531 in subjects with relapsed or refractory hematologic malignancies dosed orally once~     per day beginning at 5 mg/dose for 4 weeks with the following cohorts treating at escalating~     doses until a dose limiting toxicity or a recommended Phase 2 dose (RP2D) is reached.~      During the dose escalation period, intra-subject dose escalation will be permitted if the~     following criteria are met:~        1. The next higher dose for the regimen has demonstrated to be safe by at least 3 subjects~          and the last subject completed one cycle without experiencing any dose limiting toxicity~          (DLT).~        2. The subject who will receive the dose escalation has not experienced a DLT.~      Once the RP2D is determined, expanded cohorts studying specific malignancies (e.g., B-cell~     NHL, WM, CLL) at the RP2D will be opened to further explore the safety, pharmacology, and~     activity of ARQ 531 as monotherapy.~   "
30905|NCT03162523|"~     There are 3 articles that will be written about the experience with HDR-brachytherapy~     (HDR-BT) in patients with high-risk prostate cancer in Norway as part of a doctorial~     thesis-project. The project will focus on survival, side-effects and dosimetry variables as~     the main points of interest.~   "
30906|NCT03162510|"~     The primary purpose of the study is to determine the maximal tolerated dose (MTD) of~     Oxaliplatin in this phase I study. The secondary objectives are to determine the response~     rate, progression free survival, overall survival, and safety profiles.~      Eligible patients will receive a triplet chemotherapy consisting of nab-paclitaxel~     (Abraxane®) 150 mg/m2 IVD 30 min followed by Oxaliplatin 60 - 85 mg/m2 IVD 2hr at D1, plus~     oral S-1 35mg/m2 and Leucovorin 30mg twice daily from D1 to D7, every 14 days as a cycle till~     disease progression.~   "
30907|NCT03162497|"~     Meibomian gland dysfunction (MGD) is among the leading causes for dry eye syndrome (DES),~     affecting millions of people worldwide. We have shown in a previous study that tear film~     thickness (TFT) is reduced in patients with DES and that this reduction correlates with tear~     break up time (BUT) as well as with the severity of subjective symptoms. Even though systemic~     tetracyclines as well as topical azithromycin can be used for the treatment of MGD, it seems~     that topical azithromycin is more effective than tetracyclines and also has the advantage of~     better tolerability. The hypothesis of the present study is that topical treatment with~     azithromycin leads to a more pronounced increase in TFT compared to oral doxycycline in~     patients with DES caused by MGD.~      The objective of this study is to compare the effect of treatment with topical azithromycin~     or oral doxycycline on tear film thickness in patients with DES caused by MGD.~   "
30908|NCT03162484|"~     Most individuals who have survived an acquired brain injury (ABI) present consequences~     affecting the sensorimotor, cognitive, affective or behavioural components. The conditions~     can vary from mild to extreme. The consequences of an ABI may have a considerable impact on~     their functioning, and secondary conditions like depression or sedentary behaviours, so they~     suffer changes in their Health-Related Quality of Life (HRQoL).~      The purpose of this project is to determine the effect of a physical activity group program~     on HRQoL. As well as to identify factors that facilitate or act as a barrier to practice~     physical activity.~   "
30909|NCT03162471|"~     The aim of the study was to identify whether preoperative corneal astigmatism can influence~     corneal biomechanics and the assessment of intraocular pressure (IOP) following~     micro-incision phacoemulsification.~   "
30910|NCT03162458|"~     Purpose of the study:~        -  To assess efficacy of Anaferon for children liquid dosage form in the treatment of acute~          upper respiratory tract infections.~        -  To assess safety of Anaferon for children liquid dosage form in the treatment of acute~          upper respiratory tract infections.~   "
30911|NCT03162445|"~     This is a observational study to investigate the degree to which bone mineral density is~     impaired in boys with autism compared with typically developing controls.~   "
30912|NCT03162432|"~     The goal of this study will be to assess the safety and efficacy of high-dose interval~     Vitamin D3 therapy in children and young adults with Inflammatory Bowel Disease being treated~     with serial Remicade infusions.~   "
30913|NCT03162419|"~     Study design-Open label randomized controlled trial~      Study period-2 years~      Study population-All patients of ACLF admitted to ILBS for a period of two years from Feb~     2017 to Dec 2018~      All the patients of ACLF will receive standard medical therapy and will be randomized within~     48 hours of admission into three groups after screening for exclusion and inclusion~     criteria.(1:2:2) Group A-Standard Medical Therapy only Group B-Standard Medical therapy +~     Plasma exchange + GCSF Group C-Standard Medical Therapy + GCSF~   "
31009|NCT03161158|"~     This study evaluates whether tailored, peripheral ultrafiltration complementary to low-dose~     diuretics is associated with a reduction in cardiovascular mortality in 90 days after~     randomization and heart failure events in 90 days after discharge than usual care including~     stepped intravenous diuretics in acutely decompensated chronic heart failure with fluid~     overload (not fully responsive to diuretic therapy).~   "
30914|NCT03162406|"~     The subjects participating in the trial will be randomly allocated to either the group~     receiving the treatment under investigation (scaling and root planning (SRP) accompanied by~     administration of vitamin D) or to a group receiving standard treatment (SRP in conjunction~     with placebo) as the control. Random assignment of intervention will be done after subjects~     have been assessed for eligibility and recruited, but before the intervention to be studied~     begins. After randomization, the two groups of subjects will be followed in exactly the same~     way and the only differences between them will be the vitamin D/placebo that they will~     receive.~   "
30915|NCT03162393|"~     Brachial plexus avulsion injury (BPAI) caused by traction injury, especially total root~     avulsion, represents a severe handicap for the patient. Despite recent progress in diagnosis~     and microsurgical repair, the prognosis in such cases remains unfavorable. We need to find an~     relatively optimal surgical treatment.~   "
30916|NCT03162380|"~     Bipolar disorder is a mental disorder characterized by alternance of depressive and manic~     phases, separated by intercritical phases (euthymia). The majority of patients report~     occupation and professional difficulties. Sixty percent of bipolar patients are inactive .~     Indeed, according to the World Health Organisation, bipolar disorder is the second cause of~     days not worked.~      Several factors are related to the lower professional functioning observed in bipolar~     patients: early age of onset, delay of diagnosis and treatment, recurrence of thymic~     episodes, residual symptoms and cognitive disorders during euthymia, side effects of mood~     stabilizers.~      To our knowledge, no study has ever focused on well-being at work in French patients.~     However, suffering from a psychiatric disorder and the lack of support from colleagues and~     the hierarchy are risk factors for burnout, a growing health issue.~      Patients with mental illness are often victims of stigmatization, which may involve the~     professional field. In addition, thymic recurrences may alter professional functioning of~     active patients: multiplication of work disruptions, conflicts with peers. Conversely work~     can be stressful, promoting thyic relapses. It is therefore essential to better understand~     the occupational stresses of active patients suffering from bipolar disorder in order to~     promote functional remission beyond clinical remission.~      The aim of this study is to assess the level of stress and well-being at work in active~     French bipolar patients.~   "
30917|NCT03162367|"~     Different medical treatments are available for treatment of skin burns such as skin grafts~     and silver sulfadiazine ointment. These treatments are used for second degree burn as routine~     technique in burns units. Cell therapy is a new approach for treatment of skin disease.In~     this study we use autologous epidermal cell suspension to achieve better cosmetic and~     functional results in treatment of second degree burn.~   "
30918|NCT03162354|"~     To increase the accuracy of doctors' decisions to launch or forgo child abuse evaluations in~     their young, acutely head-injured patients, investigators have derived and validated a~     clinical decision rule (CDR) that detects abusive head trauma (AHT) with 96% sensitivity in~     pediatric intensive care unit (PICU) settings. This CDR Implementation Trial across eight~     PICU sites will assess the CDR's actual impact on AHT screening accuracy, identify factors~     associated with maximal physician acceptance and application of this novel AHT screening~     tool, and assess the sustainability of active CDR implementation strategies.~   "
30919|NCT03162341|"~     The objective of this research is to evaluate the correlation between DECT and US~     explorations performed in a routine clinical setting for the measurement of change in tophus~     size in gout patients after 24 months of treatment.~   "
30920|NCT03162315|"~     At the start of the controlled ovarian stimulation as a part of the IVF/ICSI treatment~     patients are informed about this trial. In case they gave informed consent and they have a~     progesterone level between 1 and 1.5 ng/ml at the day of the hCG injection, they will be~     randomised. One group of patients will have a fresh embryo transfer, in the second group all~     embryos will be cryopreserved and transfered in a subsequent (natural or artificial) cycle.~     The aim of this study is to compare clinical pregnancy rate between the two groups.~   "
30921|NCT03162302|"~     The objective of this study is to develop and evaluate novel magnetic resonance imaging (MRI)~     protocols for studying the structure and function of the human body using 1.5Tesla and~     3.0Tesla MRI scanners with or without the use of an MRI contrast agent.~   "
30922|NCT03162289|"~     The aim of this trial is an evaluation of the effectiveness of intermittent fasting as a~     supplementary therapy in patients with breast cancer and ovarian cancer in respect to quality~     of life, reduction of side effects and possible reduction in tumor progression.~   "
30923|NCT03162276|"~     Breast cancer (BC) is a major health problem and the most prevalent cancer among women.In a~     substantial proportion of familial cases, germ-line mutations in either BRCA1/2 can be~     detected. The only proven modality for active risk reduction (rather than passive early~     detection), is prophylactic surgery - prophylactic mastectomy and oophorectomy. While the~     majority of Jewish mutation carriers elect to undergo prophylactic oophorectomy at about age~     40 years, in Israel only a minority perform prophylactic mastectomy. Another ramification of~     being a mutation carrier is the emotional stress associated with that discovery.Genetic~     information has profound implications for mutation carriers. The IBSR (Inquiry-based stress~     reduction) intervention, developed by Byron Katie, trains participants to reduce their~     perceived level of stress by self-inquiry of their thoughts and beliefs connected to~     stressful circumstances or symptoms. This meditative process, named The Work, enables the~     participants to identify and question the stressful thoughts that cause their suffering. The~     core of IBSR is simply four questions and a turnaround, which is a way of experiencing the~     opposite of what the participant believes. This process is simple, powerful and provides~     skills for self-inquiry and management of stressful thoughts that can be easily implemented~     in daily life [ ]. Therefore, on the basis of previous data and beneficial observations we~     postulate that the clinical utility of IBSR mediation program may improve psychological and~     physical symptoms and quality of life among asymptomatic (oncologically healthy) BRCA1/ BRCA2~     mutation carriers. Thus, we will conduct a pilot randomized controlled trial to~     scientifically investigate the effect of this intervention effects on BRCA1/2 mutation~     carriers.~   "
31010|NCT03161145|"~     A medical review chart study in Japan to describe the treatment patterns and outcomes of~     patients with kidney cancer that is unable to be removed by surgery or that has spread. The~     clinical data is to be abstracted using electronic data capture (eDC) from patient medical~     records in Japan.~   "
30924|NCT03162263|"~     The use of neurorobotic devices into gait rehabilitative programs, including Ekso, is~     reported to increase the engagement and motivation of the patients while actively performing~     a task, and to shape the sensory-motor plasticity (SMP) and its balance between the primary~     motor areas (M1), and the fronto-parietal network (FPN) connectivity, thus contributing to~     successful gait rehabilitation. Aim of our study was to assess whether Ekso would foster the~     recovery of deteriorated FPN connectivity and SMP patterns involved in limb coordination~     during walking in a sample of patients with hemiparesis due to stroke.~      Twenty outpatients were consecutively included in this study according to the following~     inclusion criteria: (i) age ≥55 years; (ii) a first-ever ischemic supra-tentorial stroke~     (confirmed by MRI scan) at least 6 months before their enrollment; (iii) an unilateral~     hemiparesis, with a Muscle Research Council -MCR- score ≤3; (iv) ability to follow verbal~     instructions, with a Mini-Mental State Examination (MMSE) >24; (v) a Modified Ashworth Scale~     (MAS) score ≤2; (vi) no severe bone or joint disease; and (vii) no history of concomitant~     neurodegenerative diseases or brain surgery.~      Patients were randomly assigned to the experimental (Ekso gait training -EGT) of control~     group (conventional overground gait training -OGT- at a velocity matched to the Ekso gait~     training).~   "
30925|NCT03162250|"~     This is a Phase Ib, randomized double-blind, placebo-controlled multiple-ascending dose study~     to investigate the safety, tolerability, and pharmacokinetics of multiple doses of DSTA4637S~     when given in addition to anti-staphylococcal SOC antibiotics to participants with~     methicillin-resistant staphylococcus aureus (MRSA) and methicillin-sensitive staphylococcus~     aureus (MSSA) bacteremia requiring at least 4 weeks of anti-staphylococcal SOC antibiotics.~   "
30926|NCT03162237|"~     The neonatal pig islets will be used as donor culturing with our modified culture medium. At~     the same time the autologous T regulatory cells will be used to induce specific immune~     tolerance for porcine islets grafts combined the costimulation of T cell activation channel~     blockers. The treatment for type 1 diabetes will be evaluated the efficacy and safety.~   "
30927|NCT03162224|"~     This is a Phase 1b/2a, open-label, multi-center study to evaluate the safety and~     tolerability, anti-tumor activity, and immunogenicity of MEDI0457 (also known as INO 3112) a~     HPV DNA vaccine in combination with durvalumab (also known as MEDI4736) which is a human~     monoclonal antibody directed against PD-L1, which blocks the interaction of PD-L1 with PD-1~     and CD80.~      An initial three to 12 patients (Safety Analysis Run-in patients) will be enrolled and~     assessed for safety before additional patients are enrolled.~      The initial safety analysis run-in patients along with an approximate total of 50 patients~     with human papilloma virus associated recurrent or metastatic head and neck squamous cell~     cancer will be enrolled in this study and evaluated also for anti-tumor efficacy to MEDI0457~     in combination with durvalumab.~   "
30928|NCT03162211|"~     Depression is a leading cause of burden in Canada and globally. Although more people now seek~     and receive treatment for depression, there are still many who do not respond well to~     treatments. New and low-cost options are needed to improve the lives of people with~     depression. Research suggests that asking patients to complete questionnaires and sending~     feedback to their clinicians may improve depressive symptoms. Research also shows that~     encouraging individuals with depression to take part in shaping their own care can be~     beneficial. To date, no research has examined a combination of these two approaches. This~     project aims to investigate the benefits of providing personalized feedback to patients and~     clinicians in order to improve the care and outcomes for people with depression in Canada. To~     answer this research question, adults who are diagnosed with depression will be placed in one~     of two groups: 1. The patient and clinician will receive feedback to help guide further care~     based on the patient's responses to questionnaires 2. The patient and clinician will not~     receive feedback. The feedback form has been developed with input from clinicians,~     researchers and people with lived experience of depression, and follows new Canadian~     treatment guidelines. Information including depressive symptoms, quality of life, personal~     goals for recovery, and healthcare costs will be collected for a year or longer using an~     online data collection platform. The research team includes clinician-scientists, healthcare~     managers, educators, primary care physician and people with lived experience of depression.~     This project has the potential to deliver significant health benefits for individuals with~     depression, lessen the population burden of depression and improve the health care system by~     optimizing care delivery and improving quality of life at low cost.~   "
30929|NCT03162198|"~     All consecutive patients with liver cirrhosis, with clinical and imaging features suggestive~     of Hepatocellular Carcinoma (HCC) attending the Department of Hepatology, Institute of Liver~     and Biliary Sciences (ILBS) from February 2017 to December 2018 will be evaluated for~     inclusion.Based on the previous years data of HCC patients admitted to ILBS.~      Cirrhotic patients aged 18-70 years, with HCC proven by typical radiological features of~     arterial enhancement and delayed wash-out, on one or both of dynamic Computerized Tomographic~     or dynamic Magnetic Resonance Imaging (MRI), as per updated American Association for the~     Study of Liver Disease (AASLD) guidelines (details in appendix1).~      Age and gender matched patients with cirrhosis, but without HCC, seen during the same study~     period will serve as controls.~      Patient characteristics, etiology of cirrhosis, and liver function parameters will be noted.~     Investigator will stage the included patients as per the Barcelona Cancer of Liver Cancer~     (BCLC) criteria (details in appendix1). Investigator will then estimate Circulating Tumor~     Cells (CTC) and cfDNA in peripheral blood samples of the patients and controls.~   "
30930|NCT03162185|"~     With this study, the investigators aim to test whether acute administration of selective~     serotonin reuptake inhibitors (SSRI) improves motor performance in a sequential motor~     learning task in comparison to placebo in healthy humans.~   "
30931|NCT03162172|"~     Congenital adrenal hyperplasia (CAH) is a genetic rare disease, which alters the adrenal~     production of gluco and mineralo corticoids. The treatment consists in supplementing children~     using hydrocortisone. Despite care for these children has improve substantially across~     decades, short adult height still remains an important consequence of the disease. About 20 %~     of patients have an AH below 2 standard deviations compared to their expected height.~      In the OPALE model study, the investigators have collected data from a cohort of 496 French~     patients, born between 1970 and 1991 and with a known genotype. Using their age, sex, growth,~     disease, bone maturation and pubertal data, they have built a model which allows to predict~     their AH using data available at 8 years of age. This model has shown that the currently used~     formula to calculate the predicted AH (Bayley Pineau's method) is not applicable to children~     with CAH.~      In this project, the investigators plan to use the prediction model to compare the AH in~     patients who have received GH treatment to their predicted AH using the model.~      The hypothesis is that GH improves the AH in such patients. Existing cohorts have shown~     improved growth celerity, and growth expectation using the Bayley-Pineau formula), but this~     has not been shown on the actual AH.~      This study will allow to reinforce the investigators' hypothesis.~   "
30932|NCT03162159|"~     Congenital Adrenal Hyperplasia (CAH) is a genetic rare disease, which alters the adrenal~     production of gluco and mineralo corticoïds. The treatment consists in supplementing children~     with hydrocortisone. Despite care for these children has improved substantially across~     decades, short adult height (AH) still remains an important consequence of the disease. About~     20% of patients have an AH below 2 standard deviations compared to their expected AH.~      In the OPALE-Model study, the investigators want to collect data from a cohort of 496 CAH~     French patients, born between 1970 and 1991 with a known genotype. Using their age, sex,~     growth, disease, bone maturation and pubertal data, the investigators will build a model~     which allows to predict their AH using data available at 8 years of age. The growth charts~     built from this cohort have shown that currently used formula to calculate the predicted AH~     (Bayley-Pineau's formula) is not applicable to children with CAH.~      In this project, the investigators plan to compute an AH prediction model using data from~     children born between 1970 and 1993, and to validate the model using data from a different~     cohort (i.e. children born between 1994 and 1998). this choice was due to availability of~     data for computing the model first, and in a second stage, data from more recently born~     patients.~   "
30933|NCT03162146|"~     The individual characteristics and interactions of health care workers in intensive care~     units may influence patient safety. This study aims to quantify the influence of team~     familiarity among the members of medical and nursing staffs on risk of patient death.~   "
30934|NCT03162133|"~     A randomized controlled 3-month trial was conducted with two post-treatment assessments of 86~     breast cancer survivors receiving Aromatase Inhibitors therapy assigned to either 12 weeks of~     90-minute three times per week Baduanjin exercise classes or a wait-list control.~     Participants completed fitness assessments, measurements of lipopolysaccharide-stimulated~     production of proinﬂammatory cytokines interleukin-6 (IL-6), tumor necrosis factor alpha~     (TNF-α), interleukin-1β(IL-1β) ,C-reactive protein (CRP) ，BMI，BMD and questionnaires to~     measure QoL, fatigue, sleep quality, Aromatase Inhibitor-Induced Arthralgia, symptoms of~     climacteric syndrome were completed at baseline and 3 months.~   "
30935|NCT03162120|"~     Atrial fibrillation (AF) is the most common arrhythmia in clinical practice with a prevalence~     reaching 5% in patients older than 65 years and an incidence that increases progressively~     with age.1 According to the most recent guidelines, class Ic anti-arrhythmic drugs are~     considered the first line treatment in patients without significant structural heart disease.~     Flecainide is effective in preventing AF recurrences in 31-61% of cases according to~     different studies.2-5 A recent study showed that the combination of Flecainide and Metoprolol~     improves effective rhythm control in patients with persistent symptomatic AF compared to~     Flecainide or Metoprolol alone.6 In contrast, the combination of Flecainide and Metoprolol~     conferred no significant benefit over Flecainide alone in patients with paroxysmal AF. This~     suggests different underlying mechanisms for paroxysmal and persistent AF. Pulmonary veins~     are likely the main focus triggering paroxysmal AF while in persistent AF the role of~     pulmonary veins is less important.~   "
30936|NCT03162107|"~     The goals of this research are to understand adherence and retention in care for multi-and~     extensively drug-resistant tuberculosis (M/XDR-TB) patients using a mixed methods approach.~   "
30937|NCT03162094|"~     This is a first-in-human phase I/II randomized, double-blind, placebo (vehicle)-controlled,~     multicenter study to assess the Safety and Efficacy of AVX-012 Ophthalmic Solution in~     subjects with Mild-to-Moderate Dry Eye Syndrome.~      The study consists of two parts (part A and part B):~   "
30938|NCT03162081|"~     The project focuses on investigating problematic medication use, especially overuse of~     potentially addictive drugs among the elderly.~      The investigators aim firstly to develop and validate instruments for detecting and~     describing behavioral aspects and consequences of dependence on, and misuse of, prescription~     medication among elderly.~      In addition to evaluating diagnostic utility of screening instruments, the investigators aim~     to identify and report characteristics, risk factors and consequences of medication misuse~     and dependence among the elderly.~   "
30939|NCT03162068|"~     Osteoporosis induced by glucocorticoids excess constitutes the main cause of secondary~     osteoporosis. Most of data available are provided from cohort studies of patients treated by~     corticosteroids, affecting among 1% of population. In contrast, very few data on osteoporosis~     are available in the Cushing syndrome (CS), a rare disease affecting 1 or 2 million of~     inhabitants, and characterized by an endogen glucocorticoid excess production. This affection~     is responsable of frequent fractures, occuring in 30-60% of patients (vertebral asymptomatic~     in 50% of case, hip, ribs). Fractures occurs often frequently above the threshold usually~     used for osteoporosis (T-score<-2.5), most often in the range of osteopenia. These data~     suggest that surface bone density isn't sufficient to characterize bone fragility,~     architectural factors are probably involved, and should be evaluated. The specificity of~     osteoporosis induced by endogen glucocorticoids excess in comparison with osteoporosis~     induced by estrogenic deficiency in post-menopausal women is poorly known, especially in~     endogen glucocorticoid excess.~      A recent microarchitecture studies showed alterations of cortical compartment in patients~     with Cushing's syndrome, confirming by our preliminary preclinical data from a transgenic~     murin model of Cushing's syndrome.~      In these ten last years, new radiologic tools have been developped, and are able to evaluate~     bone architecture. The peripheral Quantitative Computed analyses the bone architecture with~     distinction between cortical and trabecular compartment.~      Therefore, we aim to determine the specificity of osteoporosis induced by glucocorticoids~     excess in comparison to post menopausal osteoporosis thanks to pQCT analysis.~   "
30940|NCT03162055|"~     This is a phase IIIb randomised, double-blind, double-dummy, multicentre, parallel group, 24~     week study to assess the efficacy and safety of Glycopyrronium/Formoterol Fumarate (GFF)~     fixed-dose combination 7.2/4.8 μg 2 inhalations twice daily compared to~     Umeclidinium/Vilanterol (UV) 62.5/25 μg fixed-dose combination 1 inhalation once daily in~     Patients with moderate to very severe COPD.~   "
30941|NCT03162042|"~     The main objective of our study was to determine the modifications of blood myostatin and~     activin A concentrations associated with head and neck cancers. Secondary objectives~     consisted in studying their influence on the occurrence of cachexia, bringing the proof of a~     tumoral secretion of these factors, and then determining the effect of tumor removal.~   "
30945|NCT03161990|"~     The functional outcome and quality of life after treatment for an infected hip arthroplasty~     have been found to be significantly worse compared to an uncomplicated arthroplasty. However,~     the type of revision surgery chosen to treat the infection plays a role for the functional~     outcome. The concept of DAIR (debridement, antibiotics and implant retention) has been shown~     to yield god results with respect to infection control in cases of early infection with a~     stable implant and better functional results than a to-stage revision. In patients where~     infection control was achieved after just one DAIR procedure the functional outcome was~     comparable to an uncomplicated primary arthroplasty. However, it is not known if the~     operative approach used for the primary and revision surgery plays a role for the functional~     result after treatment of an infected total hip arthroplasty with DAIR. The project's aim is~     to investigate if the choice of the operative approach (transgluteal or posterior) for the~     primary hip replacement and the revision surgery has an influence on the functional result~     after debridement and implant retention for an infected total hip replacement.~   "
30946|NCT03161977|"~     This is an observational study designed to research the effect of mannitol on the~     concentration of intraoperative serum potassium in patients undergoing craniotomy, and to~     guide the safe use of mannitol during craniotomy.~   "
30947|NCT03161964|"~     Impaired awareness of hypoglycemia is common in type 1 diabetes (T1DM) patients. Impaired~     hypoglycemia awareness increases severe hypoglycemia risk by six-fold. Severe hypoglycemia~     compromises quality of life and can potentially cause death. The long-term goal of this pilot~     study is to lead to the development of novel therapeutic approaches to improve hypoglycemia~     awareness and thus prevent severe hypoglycemia development in T1DM population with impaired~     awareness of hypoglycemia.~      It is hypothesized that propranolol will improve hypoglycemia recognition in T1DM. The~     specific aims of the study are to determine whether propranolol treatment improves subjects'~     recognition of hypoglycemic episodes, and improves hypoglycemic awareness scores; whether~     propranolol favorably increases hypoglycemia blood glucose nadir, decreases~     onset-to-treatment/recovery time (i.e. hypoglycemia duration), and reduces~     hypoglycemia/severe hypoglycemia frequency; and, whether propranolol reduces fear of~     hypoglycemia and improves overall blood glucose control.~   "
30948|NCT03161951|"~     Method for diagnostics of the origin of infections (bacterial vs viral) based on the~     identification of activation markers of blood neutrophils and monocytes will be developed.~   "
30949|NCT03161938|"~     The aim of this study is to investigate the effect of a single preoperative high-dose steroid~     injection on complications in the immediate postoperative phase after periacetabular~     osteotomy. Primary outcome is the proportion of patients who have moderate to severe~     postoperative pain in the post anaesthesia care unit. Secondary outcomes are organspecific~     complications in the post anaesthesia phase, pain and nausea the first 5 days, wound~     infection and readmissions the first 30 days after surgery.~      The investigators hypothesize that the frequency of moderate to severe pain and organspecific~     complications in the post anaesthesia care unit will be lower among patients receiving high~     dose dexamethasone. The investigators hypothesize, that there will be no difference in wound~     infections or readmissions.~   "
30950|NCT03161925|"~     In order to make better use of clinical resources of the real world, strengthen the~     standardization of PLC diagnosis and treatment, and constantly improve the academic level of~     liver cancer in China, we intends to launch Chinese Liver Cancer clinical Survey project in~     cancer specialized hospitals and large general hospitals and to explore the best clinical~     pathway of PLC multidisciplinary consultation.~   "
30951|NCT03161912|"~     AURIGA is designed to collect data from routine clinical practice on the effectiveness and~     utilization of intravitreal aflibercept in the treatment of visual impairment due to diabetic~     macular edema (DME) or macula edema secondary to retinal vein occlusion (RVO).~      The primary objective of this observational study (OS) is to evaluate the effectiveness of~     intravitreal aflibercept in 4 cohorts (with/without prior treatment in DME or macular edema~     secondary to RVO) in each of the participating countries.~      Additionally, utilization and treatment regimens in routine clinical practice will be~     described.~      Health care resources and services as well as health out-comes related to vision loss will be~     evaluated based on information collected using the AURIGA patient questionnaires.~   "
30952|NCT03161899|"~     Thalassemia is a blood disorder passed down through families in which the body makes an~     abnormal form of hemoglobin. There are 2 main types of thalassemia; Alpha & Beta thalassemia.~     Alpha thalassemia: occurs when a gene or genes related to the alpha globin protein are~     missing or mutated.~      Beta-thalassemia syndromes are a group of hereditary blood disorders characterized by reduced~     or absent beta globin chain synthesis. Beta-thalassemias can be classified into:~      Silent carrier: completely asymptomatic with normal hematological parameters.~     Beta-thalassaemia minor (beta-thalassaemia trait): usually asymptomatic; diagnosis is made~     during a work-up for mild anemia.~      Beta-thalassaemia intermedia: usually a similar presentation to beta-thalassaemia major;~     symptoms are usually less pronounced and the course is usually more insidious.~      Beta-thalassaemia major : In which there is complete absence of hemoglobin A~   "
30953|NCT03161886|"~     This prospective, interventional study aims this to determine the efficacy and safety of a~     PCE-based treat-to-target strategy in order to achieve Mucosal Healing (MH) and deep~     remission (DR) of pediatric Crohn's Disease (CD) over 52 weeks.~   "
30954|NCT03161873|"~     In this study physiological data is measured using wearable sensors as well as hormonal and~     ultrasound measurements of growing follicles/ ovulation in a group of endocrinologically~     healthy women with regular cycles, who aim for a spontaneous pregnancy. These women were~     recruited to generate reliable data on changes of the measured physiological parameters in a~     healthy menstrual cycle, as well as to evaluate physiological changes associated with early~     pregnancy.~      All pregnancies beginning during the study period are to be monitored to their natural end,~     in order to evaluate how the same nine physiological parameters are changing during~     pregnancy, how strong the variations of the parameters during pregnancy are, and whether they~     could be associated with early onsets of pregnancy complications such as premature birth or~     pre-eclampsia. This will be highly valuable to develop study protocols for the specific~     evaluation of the screening potential of pregnancy complications.~   "
31011|NCT03161132|"~     Impact of the combination of Olaparib and Pegylated Liposomal Doxorubicin on improvement of~     progression-free survival at 6 months in patients with platinum resistant advanced ovarian~     cancer.~   "
30955|NCT03161860|"~     Global aging and the growing burden of chronic diseases represent a challenge. Innovative~     interventions acting upon health determinants, like social participation, are required.~     Social participation, defined as the involvement of a person in activities that provide~     interactions with others in the community is critical to promote health and prevent~     disabilities. Many older adults do not have equitable opportunities to achieve full social~     participation, and interventions under-empower their personal and environmental resources and~     only reach a minority. To optimize current practices, the Personalised citizen assistance for~     social participation (APIC), an intervention demonstrated as being feasible and having~     positive impacts, needs further evaluation.~      The first aim of this study is evaluate the impacts of the APIC on older adults' health,~     social participation, life satisfaction and healthcare services utilisation. The second aim~     is to evaluate the cost-effectiveness of the intervention. In parallel, the implementation of~     the APIC, including factors facilitating and impeding it, will be documented.~      Concerning the first two objectives, two hypotheses are formulated: 1) the APIC will prevent~     a decline in older women's and men's health, social participation and life satisfaction, and~     reduce their use of healthcare services, and 2) the APIC will be associated with lower costs,~     from older adults', healthcare system and societal perspectives, including healthcare~     expenditures.~   "
30956|NCT03161847|"~     The objective of this study is to test a set of clinical outcome measures longitudinally in a~     cohort of OPMD patients to identify ones that show quantifiable change over time as the~     disease progresses. The investigators' goal is to delineate the natural history of OPMD.~   "
30957|NCT03161834|"~     The purpose of this study is to evaluate whether increased mutant ESR1 allele fraction in~     plasma ctDNA 3-6 weeks after initiating salvage endocrine therapy is predictive of~     progression free survival in patients with ER+ metastatic breast cancer.~   "
30958|NCT03161821|"~     The purpose of this study is to identify circulating tumor cells in patients with solid~     tumors. Quantify and characterize these cells, collect patient information in regards to the~     patient's cancer. Develop a database and a sample repository where future analysis could be~     done.~   "
30959|NCT03161808|"~     Over 1,900 mutations in the gene for the cystic fibrosis transmembrane conductance regulator~     (CFTR) protein are implicated in causing Cystic Fibrosis (CF). Potential therapies that~     directly target defective CFTR are being evaluated in important clinical trials, but most~     target the most common CFTR mutation F508del. Many patients with rare CF mutations are not~     able to participate in those studies. The RARE study is specifically designed for people with~     CF caused by two pre-mature stop codon mutations.~      This is a multi-site, specimen collection study. Investigators will collect blood and nasal~     cells from each participant. Some participants may also choose to participate in an optional~     Rectal Biopsy Sub-Study to collect intestinal cells. Cells from these specimens will be used~     to test future CFTR modulators to see if they might work for people with two pre-mature stop~     codon mutations. Having cells to test in the lab is an important first step in identifying~     potential new therapies for people with these mutations.~   "
30960|NCT03161795|"~     PURPOSE: Assess the risks of long-term opioid therapy, especially opioid-related disorders~     such as opioid-related chemical coping in chronic noncancer pain patients.~      Pain, particularly chronic pain, is a major threat to the quality of life worldwide and will~     become more so as the average age increases. Currently, over 30% of the world's population is~     known to have chronic pain. Opioid agonists are effective medicines for the treatment of~     moderate and severe pain. Although opioid consumption has increased in the past few decades,~     it remains below the requirements in most countries. In 2010, the WHO found that 66% of the~     world population has a level of Virtually No Consumption of opioids (ACM < 3%). Conversely,~     in countries with ACM > 100% such as the U.S., drug overdose deaths (the majority involving~     an opioid) have nearly quadrupled since 1999. Long-term use of opioids for chronic noncancer~     pain patients remains controversial owing to concerns regarding analgesic tolerance and drug~     dependence. Additionally, to date research consists of very low-quality evidence, studies on~     long-term opioid use are limited, and the majority were conducted in the U.S. Particularly,~     in countries with inadequate opioid consumption like most Asian countries no studies~     addressing long-term opioid use in chronic non-cancer pain patients nor opioid-related~     disorders such as chemical coping statistics are available. Therefore, in compliance with~     growth in medical opioid use and the lack of studies in countries with inadequate opioid~     consumption, it is indispensable to figure out the characteristics of opioid-related~     disorders in chronic noncancer pain patients with long-term use of opioid therapy.~      In this study, we performed a national, multicenter, observational cohort study to address~     the current status of opioid treatment for chronic noncancer pain in South Korea, a country~     showing moderate opioid consumption. The ultimate aims of this study were to estimate the~     frequency of opioid-related disorders such as opioid-related chemical coping, to evaluate~     their functional and psychiatric characteristics, and to determine the risk factors~     associated with opioid-related disorders in chronic noncancer pain patients receiving~     long-term opioid therapy.~   "
30961|NCT03161782|"~     The aim of the study is to compare the efficacy of Proprioceptive Neuromuscular Facilitation~     (PNF) stretching and static stretching on range of motion (ROM), pain and function in elbow~     limitation.~   "
30962|NCT03161769|"~     Investigate the ability of the intra-operative, intra-aneurysmal flow evaluation to assist~     with the treatment of intracranial large aneurysms using Embolization Device(s)~   "
30963|NCT03161756|"~     The purpose of this project is to test the addition of a new treatment called denosumab to~     standard immunotherapies for patients with metastatic melanoma. Denosumab has been used for~     many years to help treat cancers such as prostate cancer and breast cancer, but it is not~     currently used in melanoma. We hope the addition of denosumab to current melanoma therapies~     will make these treatments work better without adding to the side effects.~      Who is it for? You may be eligible to join this study if you are aged 18 years or over and~     have been diagnosed with metastatic melanoma (melanoma that has spread).~      Study details: Nivolumab and ipilimumab are approved treatments for advanced melanoma in~     Australia and overseas. Patients with metastatic melanoma, who are not enrolled in a study,~     are commonly prescribed nivolumab alone or the combination of nivolumab and ipilimumab as~     standard care. However, there is limited information on the effectiveness and safety of these~     treatments in combination with denosumab. Recent melanoma research in animal models has shown~     that denosumab can make immunotherapies such as ipilimumab and nivolumab work better. Because~     denosumab has been used in patients with breast and prostate cancer for a long time and is~     safe, we now want to test the benefits and safety of adding denosumab to immunotherapies in~     this study.~   "
30964|NCT03161743|"~     This is a study to determine 1) the consistency of platelet-rich plasma produced by several~     methods, and 2) whether the platelet content of platelet-rich plasma can be accurately~     estimated from a baseline CBC platelet count.~   "
30965|NCT03161730|"~     The purpose of this study is to compare the intubation time and success rate between~     videolaryngoscopes (McGrath MAC videolaryngoscope, Pentax Airway Scope) and Macintosh~     laryngoscope in tracheal intubation in a normal and cervical immobilized manikin by novice~     airway managers.~   "
30966|NCT03161717|"~     Forty pregnant women (36 to 41 weeks gestation) will randomly allocate to two groups. Groups~     will be defined based on the method used to identify the epidural space for epidural~     anesthesia: the loss of resistance group (n=20) and the epidural electrical stimulation group~     (n=20). Pain will be assessed using a numerical visual analog scale and maternal satisfaction~     by a post-partum interview. The success rate of epidural analgesia, maternal satisfaction,~     and neonatal Apgar scores will be compared between groups.~   "
30967|NCT03161704|"~     This study involves the prospective collection of endometrial biopsy tissue, serum, plasma,~     whole blood for DNA extraction, and urine from women who will be diagnosed as having (or not~     having) endometriosis at the time of scheduled surgery. The investigators plan to enroll~     approximately 500 women to validate and optimize the use of genomic classifiers alone or in~     combination with serum markers (such as cytokines) as a non-surgical marker of disease.~   "
30968|NCT03161691|"~     Single-center, single-arm pilot study to evaluate the ability of C-arm computed tomography~     imaging to assess perfusion parameters, collateral vessels, recanalization and brain ischemia~     in patients with suspected or proven ischemic stroke or brain ischemia in the~     neuro-angiography suite.~   "
30969|NCT03161678|"~     The purpose of this investigation is to evaluate when genetic variation in the~     carboxylesterase 1 (CES1) gene influences antiplatelet therapy response, as assessed by ex~     vivo platelet aggregometry, in healthy participants treated with clopidogrel and ticagrelor.~     We hypothesize that genetic variation in CES1 will significantly impact on-clopidogrel~     platelet aggregation while having a minimal effect in ticagrelor-treated subjects.~      Specific Aim: To conduct a prospective randomized crossover study of clopidogrel and~     ticagrelor in healthy individuals stratified by CES1 genotype. Participants will be recruited~     by CES1 genotype into a randomized crossover study of clopidogrel (75 mg daily for 7d) and~     ticagrelor (90 mg twice daily for 7d) with extensive phenotyping including ex vivo platelet~     aggregometry performed pre- and post-drug administration in order to assess the interaction~     of genotype and drug choice on on-treatment platelet function.~   "
30970|NCT03161665|"~     Hematopoietic cell transplantation (BMT), or commonly referred to as blood and marrow~     transplantation (BMT), is a potentially life-saving therapy for many malignant and~     non-malignant conditions. Despite advances over the past decade, which have led to improved~     outcomes, BMT remains an intense treatment modality often requiring prolonged~     inpatient--based care. While many patients endure the acute complications of the procedure,~     it is common for BMT patients and their caregivers to experience increased risk of financial~     and emotional burden, hospital readmission, and health service utilization. This highlights~     the importance of active involvement of BMT patients in their own health care~     (self--efficacy).~      Given the intense nature of BMT, however, caregivers also play a critical role in the process~     and are a necessary component of proceeding with transplant. As such, caregiver activation on~     behalf of the patient plays a critical role in effective patient--caregiver-provider~     partnerships, which is increasingly recognized as the optimal model for health care delivery,~     particularly for those facing life--altering medical treatments. It is essential to develop~     effective strategies to enhance this partnership. Health information technology (IT)-mediated~     tools offer the potential to overcome constraints in health care delivery limited by provider~     time, complicated health information, and financial pressures. Significant gaps in knowledge~     exist on the use of health IT tools using low- cost and well- accepted delivery platforms in~     routine inpatient care, especially for high- risk or critically ill populations. We~     hypothesize that a tablet--based tool displaying personal health information could provide a~     platform to promote caregiver activation and enhance health communication.~   "
30971|NCT03161652|"~     This is a randomized, double-blind, placebo-controlled trial to evaluate the safety and~     efficacy of levosulpiride to improve retinal alterations due to diabetic macular edema and~     diabetic retinopathy~   "
30972|NCT03161639|"~     Verify, through a randomized double-blinded clinical trial, the influence in the performance~     of pulpectomies in primary teeth, based on two working length methods, electronic and~     radiographic.~   "
30973|NCT03161626|"~     This is a non-interventional, multicenter, post-marketing registry study in three patients~     with moderate or severe hereditary FX deficiency, to assess Coagadex administered~     peri-operatively for hemostatic cover in major surgery during routine post-marketing use.~   "
30974|NCT03161613|"~     This is a post-marketing study of patients who started nivolumab as first- or second-line~     therapy for metastatic melanoma or as second-line therapy for metastatic squamous non-small~     cell lung cancer (SqNSCLC) , metastatic non-SqNSCLC, metastatic renal cell carcimona (RCC),~     or recurrent or metastatic squamous cell carcinoma of the head and neck cancer (SCCHN), or~     third-line therapy for classical Hodgkin lymphoma (cHL) in Mexico.~   "
30975|NCT03161600|"~     This study will explore provider's screening and management practices for eligibility for~     neoadjuvant therapy from baseline to following the project intervention (use of a novel~     existing technology, the Carevive Care Planning System at the point of care plus provider~     continuing medical education.~   "
30976|NCT03161587|"~     Chronic obstructive pulmonary disease (COPD) is a complex disease characterized by multiple~     clinical manifestations as well as co-morbidities. While COPD subjects have traditionally~     been classified based solely on airflow limitation (forced expiratory volume in one second~     [FEV1]), a new classification system was introduced in the year of 2011 by the Global~     Initiative for Chronic Obstructive Lung Disease (GOLD) that recommended subjects with COPD~     should be classified based on a combination of airflow limitation, disease impact (determined~     by symptom burden and activity limitation) and history of exacerbation. This approach results~     in the classification of subjects in four groups: A (low risk, less symptoms), B (low risk,~     more symptoms), C (high risk, less symptoms), and D (high risk, more symptoms). This~     classification system was further refined in year 2013, specifically around the history of~     exacerbation definition, where having ≥1 exacerbation leading to hospital admission in~     preceding year was added as a criteria for classification into the high risk C or D groups.~     Further, in the year 2016, there was a refinement of the disease impact criteria that suggest~     the use of the COPD Assessment Test (CAT) score (over the Modified British Medical Research~     Council Dyspnea Scale [mMRC] score) as the preferred tool to determine classification as~     more symptoms or less symptoms. This study aims to understand subject characteristics and~     current treatment modalities in different groups classified by GOLD 2016 comprehensive~     classification system and to understand if current treatment choice is concordant with the~     GOLD recommendations in real life clinical practice in China tertiary hospitals. It will~     provide a useful point-in-time description of COPD subject characteristics and current~     treatment modalities in real life clinical practice in China.~   "
31121|NCT03159702|"~     This is an open-label, single-arm, phase II study to determine the safety of propylene~     glycol-free melphalan HCl (EVOMELA®), in combination with fludarabine and total-body~     irradiation-based reduced-intensity conditioning for haploidentical transplantation. In~     addition, the study evaluates the one-year progression-free survival of patients undergoing~     this treatment.~   "
30977|NCT03161574|"~     Neoadjuvant 5-Fu based chemoradiation followed by surgery is a standard treatment for locally~     advanced rectal cancer. However, radiation-related side effects could not be neglected. But~     this multimodality strategy failed to improve survival. Neoadjuvant chemotherapy alone may be~     an alternative strategy to minimize treatment-related toxicities without compromising the~     oncology outcome. Thus, patients with MRI-defined CRM-positive rectal cancer will receive 6~     cycles of neoadjuvant treatment with FOLFOXIRI followed by surgery. The purpose of the study~     is to evaluate the efficacy of FOLFOXIRI alone as neoadjuvant treatment in treating patients~     with locally advanced rectal cancer.~   "
30978|NCT03161561|"~     COPD is a leading cause of lung disease and a common cause of hospitalisation, time off work~     and death. Smoking is the major factor associated with development of COPD. Nevertheless why~     some people develop COPD while others, including many smokers do not, is poorly understood. A~     central feature of COPD is accumulation of a particular type of white blood cell, the~     neutrophil, which is a key component in defence against bacterial infection in the lung~     airway. As disease progresses the small airways of many patients with COPD start to~     accumulate bacteria, which are normally lacking in the small airways of healthy individuals~     or smokers who lack COPD. The accumulation of bacteria in the smaller airways of many~     patients with COPD may be important to the development of the disease. Researchers will test~     if blood cells, which normally ingest and kill bacteria, have a reduced ability to perform~     this function in patients with COPD and whether the clearance of these blood cells after they~     have performed their role in protecting against infection is impaired. Researchers will~     relate these findings to the clinical features of COPD in a well-defined group of patients~     who have had extensive characterisation of their disease. In particular, researchers will~     relate this defect to the presence of frequent flares of disease, which lead to symptoms of~     wheezing and shortness of breath. Comparison will be made between blood cells obtained from~     the lung and from he blood to determine if the alterations are specific to the lung.~     Researchers will identify particular molecular alterations in the way these blood cells~     respond to bacteria and determine whether they can correct these alterations using agents,~     which are used to treat a range of different medical conditions, but which they predict might~     correct these alterations in function. The aim of this programme of work is ultimately to~     identify new ways in which to treat COPD and the agents, which the researchers demonstrate~     have the greatest potential to correct the abnormalities in cell function of patients with~     COPD, would in the future be studied in clinical trials.~   "
30979|NCT03161548|"~     This is an open-label, non-comparative phase II clinical trial to assess efficacy and safety~     of tongue conservation treatment with sequential induction chemotherapy, tongue conservation~     surgery and postoperative concurrent chemoradiotherapy (CCRT) in patients with advanced oral~     tongue cancer.~   "
30980|NCT03161535|"~     This study will investigate the effectiveness of a rehabilitation program in improving sleep~     quality, emotional distress, circadian rhythms, and quality of life in patients with~     esophageal cancer in Taiwan.~      Hypothesis:~        1. The quality of life in exercise group is significant improving than usual-care group at~          3rd, 6th, 12th, 24th, and 36th month.~        2. The quality of sleep in exercise group is significant improving than usual-care group at~          3rd, 6th, 12th, 24th, and 36th month.~        3. The emotional distress in exercise group is significant improving than usual-care group~          at 3rd, 6th, 12th, 24th, and 36th month.~        4. The circadian rhythms in exercise group is significant improving than usual-care group~          at 3rd, 6th, 12th, 24th, and 36th month.~   "
30981|NCT03161522|"~     The goal of this clinical research study is to learn if adding additional chemotherapy and~     radiation, either with or without surgery, can help to control esophageal or gastric cancer~     with oligometastases in patients whose disease did not get worse after receiving at least 6~     cycles of chemotherapy as part of their standard care.~      Oligometastases means there are less than 3 places in the body where the disease has spread.~   "
30982|NCT03161509|"~     Sleeve gastrectomy may affect drug pharmacokinetics in several potential ways. We will~     measure pharmakokinetics of paracetamol and antiepileptic drugs before and 6 months after~     sleeve gastrectomy.~   "
30983|NCT03161496|"~     It is general that there are many factors for individual differences of drugs in clinical~     application, of which genetic factors accounted for more than 20%. Novel oral~     anticoagulants-NOACs (include rivaroxaban, apixaban, dabigatran and so on) have advantages of~     convenient use and no need of monitoring, compared with the traditional vitamin K antagonist.~     With lack of predicted biomarkers, especially the research data of Chinese, it has the~     important significance in studying individual differences of NOACs in the anticoagulant~     efficacy and safety, through the pharmacogenomics research.~      The aim of this study is to determine the polymorphism of drug metabolizing enzymes, drug~     transporters and drug target genes in Chinese population. By detecting the gene polymorphism,~     we intend to study the pharmacokinetic/ pharmacodynamics/ pharmacogenomics (PK-PD-PG)~     correlation of NOACs and provide scientific basis for accurate medication guide for people to~     use NOACs.~   "
30984|NCT03161483|"~     The purpose of this Phase 2, multicenter, randomized, placebo-controlled, double-blind study~     to evaluate the efficacy and safety of an oral treatment regimen of CC-220 versus placebo in~     adult subjects with active systemic lupus erythematosus.~      Approximately 280 subjects with a documented diagnosis of SLE will be randomized 2:2:1:2 to~     receive CC-220 (0.45 mg QD, 0.3 mg QD or 0.15 mg QD) or identically appearing placebo.~   "
30985|NCT03161470|"~     Benign paroxysmal positional vertigo (BPPV) is the most common inner ear cause of dizziness.~     It has been reported that up to 900 of every 10,000 people in the United States experience~     this problem with an estimated annual healthcare cost approaching $2 Billion. This problem~     occurs when calcium carbonate crystals which are present and needed in one part of the~     balance area of the inner ear become displaced to a different part of the balance area. This~     is very disruptive to the function of the inner ear and results primarily in intense vertigo.~     Nausea,imbalance, and falls can also occur. The accepted course of management for BPPV is the~     use of repositioning maneuvers which are completed by moving patients through specific~     head/body positions that literally reposition the displaced crystals out of the wrong area.~     These treatment methods are reported to be effective for about 80% of patients after~     one-to-three treatments. For the remaining 20% of patients, more treatments may be necessary~     and for a small percentage of patients surgical options may be the only cure. Additionally,~     some patients with BPPV are not able to physically move into the needed positions because of~     hip and neck problems, spinal problems, obesity, other mobility limitations, etc. Within the~     past decade, a motorized chair was developed to help reposition any patient with BPPV. There~     have been no reported adverse incidents with the motorized chair but the device was quite~     expensive so it was only available at a handful of clinical sites. At this time the motorized~     chair is no longer being manufactured. More recently, a mechanical chair was developed and~     has been in use in Europe and China. The mechanical chair has all the advantages of the~     motorized chair but with a lesser cost. The inventor of the mechanical chair has also~     developed some slight variations on treatment technique that may have the potential to~     improve treatment efficacy. We are privileged to have the only mechanical chair of this type~     in the United States. The primary purpose of the current project is to systematically~     investigate the treatment efficacy of this mechanical chair for patients with BPPV. We will~     compare treatment outcomes for patients diagnosed with BPPV using standard methods, the~     mechanical chair, and a sham condition also using the mechanical chair. A secondary purpose~     is to determine treatment efficacy for patients with covert BPPV. We will simply measure if~     treatment with the mechanical chair has any effect on patient symptoms. If we determine~     treatment is improved with the mechanical chair then it may be possible to help a greater~     number of patients with BPPV with fewer treatments.~   "
31122|NCT03159689|"~     The results from this study may help to explain if incorporating mixed nuts in a reduced~     calorie diet will lead to weight loss.~   "
44367|NCT02986061|"~     The aim of this study was to investigate whether urinary catheterization could be avoided for~     all patients undergoing total knee arthroplasty under combined spinal-epidural analgesia plus~     multi-site infiltration analgesia.~   "
30986|NCT03161457|"~     This is a multicentre, randomised, double-blind, parallel group study to compare the~     pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, safety, tolerability and~     efficacy of JHL1101 versus MabThera in subjects with moderate to severe RA who have~     previously failed at least 1 tumour necrosis factor alpha (TNF) inhibitor (i.e., intolerance~     or documented active disease despite at least 12 weeks treatment according to the TNF~     inhibitor-approved treatment and dosage), and are on concomitant treatment with MTX.~   "
30987|NCT03161444|"~     This study will estimate the cumulative incidence of Zika infection at the end of the first~     epidemic in the French West Indies in a sample of patients followed for HIV infection.~   "
30988|NCT03161431|"~     Cancers attract myeloid-derived suppressor cells (MDSCs) that prevent our own immune~     responses from destroying the cancer. This study will be the first study to begin to~     determine if the newly discovered drug SX-682 can block cancers from attracting MDSCs. This~     first study will enroll participants with melanoma, as melanoma cancer has been shown to be~     able to attract MDSCs. The study will begin to determine if SX-682 is a safe and effective~     treatment of melanoma. It is thought that SX-682 will block MDSCs from going to the cancer,~     and thus will allow a patient's own immune system to attack the cancer.~      The first participants enrolled in the study will receive for 21 days SX-682 as monotherapy.~     After 21 days participants will receive pembrolizumab therapy (an approved immunotherapy for~     melanoma) and will remain in the study for evaluations for 3 months.~      After these participants complete the monotherapy stage, the next participants will receive~     SX-682 and pembrolizumab together as combination therapy. These participants will receive the~     combination therapy and be evaluated in the study for approximately 2 years.~   "
30989|NCT03161418|"~     The purpose of this study is to evaluate the safety of orally administered KSP-910638G, a~     topically administered li-cor IRDye800CW labeled heptapeptide specific for human epithelial~     growth factor receptor 2 (HER2).~   "
30990|NCT03161405|"~     The purpose of this study is to evaluate the effect of the potent cytochrome P-450 (CYP) 3A4~     inhibitor (itraconazole) on the single-dose PK of oral TAK-906 maleate.~   "
30991|NCT03161392|"~     Mammograms performed at the Diagnostic Imaging Department of the Instituto Brasileiro de~     Controle do Câncer (IBCC - Brazilian Cancer Control Institute) will be prospectively~     evaluated. Patients who present a solitary dilated duct visualized by mammography will be~     submitted to breast ultrasonography. In case of detection of lesion, a percutaneous biopsy~     will be performed.~   "
30992|NCT03161379|"~     The purpose of this study is to evaluate the safety and clinical activity of FOLFIRINOX along~     with a whole cell vaccine with immune modulating doses of cyclophosphamide and nivolumab~     combined with Stereotactic Body Radiation Therapy (SBRT) in patients with pancreatic cancer.~   "
30993|NCT03161366|"~     Interventional, single arm, open-label, non-randomized, phase IIIb study to accumulate~     additional data on safety and effectiveness of one dose of rVSVΔG-ZEBOV-GP against Ebola~     virus disease.~   "
30994|NCT03161353|"~     The study assess the early metabolic effects of neoadjuvant treatment with trastuzumab and~     pertuzumab (± endocrine therapy) on the primary tumor and axillary lymph nodes and their~     predictive value for pathologic complete response (pCR) in the breast and axilla.~      And also assess 3-year invasive disease-free survival (iDFS) in patients with HER2-positive~     (HER: human epidermal receptor) breast cancer treated with neoadjuvant trastuzumab and~     pertuzumab (± endocrine therapy) using a FDG-PET response-adapted strategy.~   "
30995|NCT03161340|"~     Repeated implantation failure (RIF) is determined as failure to achieve pregnancy following~     at least 3 embryo transfers of high quality embryos in IVF cycles. Successful implantation~     and pregnancy depend on the activity of a variety of factors such as adhesion molecules,~     cytokines and immune cells.The process by which the foreign conceptus is accepted requires~     the appropriate function of regulatory T cells (Treg), which are known as the mediators of~     immune regulation. Tregs are capable of inducing maternal tolerance toward the fetus and~     their systemic expansion has been observed in early pregnancy. Furthermore, Th17 cells that~     play important roles in mounting inflammation are involved in the maintenance of pregnancy as~     a subset of effector T cells.The mammalian target of rapamycin (mTOR) inhibitors are~     immunosuppressive agents used after solid organ transplantation. Sirolimus as the most common~     mTOR inhibitor is able to effectively prevent allograft rejection and possesses significant~     antitumor properties. Pregnancy is a state of immunosuppression and the dysregulated immune~     responses has been observed in women with RIF. Accordingly, modulation of the immune system~     by an immunosuppressant drug may present an approach to overcome implantation failure. In~     this context, the use of Sirolimus might offer promise to achieve a better pregnancy outcome~     among women with implantation failure who undergo IVF. Based on previous findings, we~     hypothesized that Sirolimus may be beneficial for the improvement of pregnancy rate in women~     with IVF failure.~      In the current study, we performe randomized phase II clinical trial to determine whether~     Sirolimus could be used as a bona fide treatment to increase the success rate of IVF in women~     with RIF of immune etiologies.A total 121 patients with a history of at least 3 RIF after~     IVF/ET cycles that will refer to Eastern Azerbaijan ACECR ART center, Alzahra Hospital of~     Tabriz University of Medical Sciences and Infertility Treatment center ACER Qom from July~     2016 to June 2017 were select and enroll in this multicenter, randomized, double-blind, phase~     II study.~      Normal ranges for Th17/Treg cell ratios establish using 50 normal fertile women who had a~     history of normal delivery by natural conception.~      In patients with elevated Th17/Treg ratios, half of them treat with Sirolimus (Rapamune®;~     Pfizer, UK) and rest of patients not treat (control group). The patients in the treatment~     group will began Sirolimus 2 days prior to embryo transfer (ET) and will continue until the~     day of pregnancy test (15 day after ET), for a total of 17 days Sirolimus administe in a~     daily dose of 2mg.~   "
30996|NCT03161327|"~     Peripheral artery disease (PAD) affects 8-18 million in the US and is an economic burden,~     currently estimated to be greater than cancer and heart disease. Older age (> 65 years),~     smoking, diabetes and kidney diseases are some risk factors associated with PAD and are known~     to have increased morbidity and mortality.Early detection is critical for mitigating PAD~     progression. Ankle-brachial index (ABI) testing is recommended by the US Preventative~     Services Task Force as an affordable and effective screening tool for evaluating PAD risk.~      QuantaFlo™ (Semler Scientific, Inc.) is a novel, noninvasive, 510K FDA approved digital~     device that is used as a screening tool to measure ABI of patients at risk of PAD. This~     single center prospective clinical trial will evaluate the sensitivity and specificity of~     digital ABI in detecting PAD using color Doppler ultrasound and 'gold standard' angiography~     as reference. Specifically in patient undergoing dialysis and who cannot undergo ABI using~     pressure cuffs dialysis grafts/ fistulae in the arms, we will evaluate the value of digital~     ABI in detecting PAD.~   "
31061|NCT03160482|"~     Nowadays, the investigation of thyroid nodules is limited by the fact that up to 49% of the~     fine needle aspirations (FNA) performed on them are of indeterminate cytological~     signification. Moreover, no reliable molecular marker for thyroid cancer have been developed~     up to this day. The goal of this project is to study the expression of a specific kind of~     protein convertase in benign and in malignant thyroid nodules to determine its potential as a~     clinically useful biomarker.~   "
30997|NCT03161314|"~     Plantar heel pain (PHP) or plantar fasciitis is one of the major foot problems which can~     occur in any age group. It is a common encountered musculoskeletal problem that can cause~     disability, activity limitation, discomfort, and affect quality of life. It involves pain and~     inflammation of the plantar fascia, which runs across bottom of the foot and connects heel~     bone to toes. PHP frequently found in active workers aged between 25 and 65 years with the~     highest incidence in people aged between 40 and 60 years.~      However, very few studies investigated the alterations of the multisegmental foot motions and~     muscle functions in patients with PHP. To prescribe the relevant program of treatment and~     reduce risk of symptoms chronicity, it is necessary to have in-depth understanding of~     changing mechanisms in patients with PHP. To explain how the symptoms occur in patients with~     PHP, foot function is another aspect that should be determined. One of the popular~     questionnaires determining foot function is the Foot Function Index (FFI) questionnaire. It~     has been proved to have a good reliability and validity and has been translated into several~     languages. To be able to use the international standard questionnaire, it is necessary to~     translate the FFI into Thai. This can be implemented in Thailand and be able to compare the~     findings of interventional effect internationally. In addition, very few studies reported the~     effectiveness of the treatment program for patients with PHP. Among previous evidences, the~     controversial findings existed. Thus, the intervention program should be evaluated for~     obtaining the effective treatment for this population.~   "
30998|NCT03161301|"~     This study will provide mechanistic insight into the underlying causes and molecular level~     pathogenesis of periodontal diseases. We will identify key mechanisms that confer risk and~     protection. Ultimately this will lead to new and improved diagnostics and therapeutics.~     Because periodontal disease is a uniquely accessible biofilm-associated disease it will~     provide insight into many other diseases such as inflammatory bowel disease and chronic~     infections associated with indwelling catheters and artificial prostheses. Subjects with~     periodontal conditions will have therapeutic benefit from the treatments provided.~   "
30999|NCT03161288|"~     This is a single and multiple ascending dose, placebo-controlled, double-blind, Phase 1 study~     to evaluate the safety and tolerability of KY1005 in healthy volunteers.~   "
31000|NCT03161275|"~     Subsequent and non-randomised patients, adult patients qualified for major abdominal~     surgeries were enrolled~   "
31001|NCT03161262|"~     The purpose of this study is to determine whether low-cost Short Message Service (SMS)-based~     follow-up medication reminders and surveys for surgical site infection (SSI) reporting can~     improve outcomes by increasing medication adherence and earlier detection and care of SSI.~     This will be a prospective study involving enrollment of patients onto the Memora Health~     platform, a web application developed for automating SMS content to patients. Post-operative~     patients will be identified by providers and enrolled prior to discharge, after which they~     will be followed for 3 months.~      Primary endpoints include medication adherence and patient satisfaction with the text~     messaging tool. Secondary endpoints include early detection of SSIs, patient satisfaction~     with overall post-discharge care and health-related quality of life, and pertinent 30-day~     readmissions.~   "
31002|NCT03161249|"~     The aim of the study is to evaluate the effectiveness of an online intervention through a~     mobile application, specifically designed for adolescents with a First Psychotic Episode~     (FEP), as a complement to the pharmacological and therapeutic interventions they receive at~     their referral center (Treatment as usual). To do this, a longitudinal study will be carried~     out on patients with FEP and between the ages of 14 and 19, who come to the Child and~     Adolescent Psychiatry Service of the General Universitarian Hospital Gregorio Marañón in~     Madrid. Adolescents will be randomly assigned to an experimental group, where they will~     receive standard treatment plus online intervention, or a control group, where they will~     receive standard treatment.~      This online intervention, the continuation of the work of this same team researcher in the~     PIENSA program, aims to address little of the more traditional treatments and treatments~     such as community functioning, quality of life or affective symptoms. In addition, it will~     increase disease awareness, which will lead to greater adherence to treatment and fewer~     relapses and rehospitalizations.~   "
31003|NCT03161236|"~     This graduate student research study has two purposes; the first purpose is to examine the~     criterion validity of the Y Balance Test (YBT) with the Limits of Stability Test (LOS) in~     healthy middle-aged adults. The second purpose is to examine balance changes using the YBT~     following a home-based exercise program.~   "
31004|NCT03161223|"~     This is an open-label, Phase 1/2a, dose-finding study with an initial phase 1 portion,~     articulated in four separate treatment arms, followed by a dedicated phase 2 for qualifying~     treatment Arm(s).~      The primary objective of the phase 1 portion is to determine the maximum tolerated dose (MTD)~     and dose limiting toxicity (DLT) of the combinations of: Durvalumab, pralatrexate, and~     romidepsin (Arm A); durvalumab, oral 5-azacitidine, and romidepsin (Arm B); durvalumab and~     romidepsin (Arm C); or durvalumab and oral 5-azacitidine (Arm D), in patients with relapsed~     or refractory (R/R) peripheral T-cell lymphoma (PTCL). The safety and toxicity profile of~     these combinations will be evaluated throughout the entire study.~      If one or more of the combinations in Arms A, B, C, or D are found to be feasible and an MTD~     is established, the phase 2 portion of the study will be initiated for the combination(s)~     with the strongest efficacy signal provided acceptable toxicity.~   "
31005|NCT03161210|"~     The aim of this study is to compare the treatment effects of dextrose prolotherapy, saline,~     and mepivacaine for deactivating myofascial trigger points within the jaw muscles.~   "
31006|NCT03161197|"~     Kidney Disease subjects will be recruited to take part of a mindfulness-based stress~     reduction intervention for 8-10 sessions. All subjects will complete a baseline interview,~     one follow-up at 3 months and the close out interview at 5 months.~   "
31007|NCT03161184|"~     This study investigates whether training Community Health Workers (CHW) to use a~     smartphone-based prenatal counseling application as a job aid instead of the existing paper~     based standard is associated with increased women's use of maternal health services in~     Singida region, Tanzania.~   "
31008|NCT03161171|"~     The study quantitates behavioral challenges in mucopolysaccharidosis type I-III and parental~     coping strategies~   "
31062|NCT03160469|"~     a prospective intragastric elipse balloon effect on weight loss for certain BMI. this study~     also proposed to assess the safety of the elipse balloon~   "
31012|NCT03161119|"~     Numerous published trials now document that the embryo transfer (ET) procedure has a huge~     impact on pregnancy and delivery rates after IVF (In Vitro Fertilization).~      To compare the ease of use (defined as the rate of successful atraumatic insertion) of~     different types of embryo transfer (ET) catheters.~      This prospective randomized unblinded controlled clinical trial is performed to determine if~     there is any difference in ease of use among 2 different catheters : Cook k-soft-5000, Cook~     K-JETS-551910-S.~      Inclusion criteria: patients < / = 38 years of age, body mass index (BMI) between 18 and 28,~     at least one frozen-thawed blastocyst transferred.~      Exclusion criteria: ICSI (Intracytoplasmic Sperm Injection)-TESE (Testicular Sperm~     Extraction) IVF cycles.~      A number of 352 consecutive women undergoing embryo transfer will be selected for this~     prospective, randomized controlled trial. Two protocols for endometrial preparation will be~     used before frozen/thawed blastocyst transfer: the modified spontaneous protocol and the~     oral/transdermal preparation protocol. ET will be done with patient in lithotomy position,~     under ultrasound guidance. No anesthesia will be used for the procedure.~      176 patients will be enrolled in this trial and randomized to enter one of the two catheter~     group.~   "
31013|NCT03161106|"~     The study will be conducted on patients attending /admitted to Department of Hepatology from~     April 2017 to December 2018 at ILBS, New Delhi .~      Clinical, anthropometric and biochemical assessment will be done by candidate, co-supervisors~     and supervisor. Patients in treatment group will receive nutritional therapy in the form of~     30-kcal/kg/day and 1.5gm/kg/day protein with supplements. Other patients will continue diet~     that they were receiving before along with lactulose. Previous treatment and prophylaxis of~     variceal bleed any (endoscopic variceal ligation or beta blocker) will be continued as~     before. All subjects will be followed up every month for treatment compliance and for~     development of any complications.~   "
31014|NCT03161093|"~     The primary objective of the study is to evaluate the efficacy of fasinumab compared with~     placebo, when administered for up to 16 weeks in patients with osteoarthritis (OA) of the~     knee or hip.~      The secondary objectives of the study are:~        1. To evaluate the efficacy of fasinumab compared with naproxen, when administered for up~          to 16 weeks in patients with OA of the knee or hip~        2. To evaluate the efficacy of fasinumab compared with placebo, when administered for up to~          52 weeks in patients with OA of the knee or hip~        3. To assess the safety and tolerability of fasinumab compared with naproxen, when~          administered for up to 16 weeks in patients with OA of the knee or hip~        4. To assess the safety and tolerability of fasinumab compared with naproxen, when~          administered for up to 52 weeks in patients with OA of the knee or hip~        5. To evaluate the pharmacokinetic (PK) profile of fasinumab administered to patients for~          up to 52 weeks~        6. To evaluate the immunogenicity of fasinumab administered to patients for up to 52 weeks~   "
31015|NCT03161080|"~     The prevalence and incidence of dry eye syndrome (DES) is constantly increasing. Several~     therapeutic strategies have been proposed, but still no ideal regimen has been found.~     Recently, a new method for the non- invasive measurement of tear film thickness (TFT) based~     on optical coherence tomography (OCT) has been developed. It has been shown in previous~     studies that TFT correlates well with objective signs as well as with subjective symptoms of~     DES.~      In the present study the effects of three different topical lubricants (Neovis total multi®,~     Vismed multi® and Hydrabak® eye drops) on tear film thickness in patients with moderate to~     severe DES will be investigated using this device.~      Tear film thickness will be measured at baseline and at defined time points after single~     instillation. The course of tear film thickness during this study day will provide~     information about the corneal residency time of the three different eye drops. Patients with~     moderate to severe DES will be randomized to receive either Neovis total multi®, Vismed~     multi® or Hydrabak® eye drops. Assessment of lipid layer thickness of the tear film will be~     performed before and at pre-specified time points after instillation as secondary outcome.~      Other clinical measures for DES such as determination of tear film break up time (TFBUT),~     corneal fluorescein staining, Schirmer I test and subjective assessments will also be~     performed.~   "
31016|NCT03161067|"~     The Bidirectional Cortical Neuroprosthetic System (BiCNS) consists of NeuroPort~     Microelectrode Array Systems and NeuroPort Electrodes (Sputtered Iridium Oxide Film), Patient~     Pedestals, the NeuroPort BioPotential Signal Processing System, and the CereStim C96~     Programmable Stimulator. The goals of this early feasibility study consist of safety and~     efficacy evaluations of this device.~   "
31017|NCT03161054|"~     This is a phase II study of metronomic chemotherapy in elderly non-fit patients (>65 years)~     with aggressive B-Cell lymphomas~   "
31018|NCT03161041|"~     Selected patients with peritoneal carcinomatosis (PC) from colorectal cancer (CRC) benefit~     from cytoreductive surgery (CRS) combined with intraperitoneal chemoperfusion (IPC). However,~     even after optimal cytoreduction, systemic and locoregional recurrence are common.~     Perioperative chemotherapy with bevacizumab (BEV) may improve the outcome of these patients.~     The BEV-IP study is a phase II, single-arm, open-label study aimed at patients with~     colorectal or appendiceal adenocarcinoma with synchronous or metachronous PC. This study~     evaluates whether perioperative chemotherapy including BEV in combination with CRS and~     oxaliplatin-based IPC results in acceptable morbidity and mortality (primary composite~     endpoint). Secondary endpoints are treatment completion rate, chemotherapy-related toxicity,~     pathological response, progression free survival, and overall survival.~   "
31019|NCT03161028|"~     The purpose of the study is to determine if lipoic acid can preserve mobility and protect the~     brain in progressive forms of multiple sclerosis.~   "
31020|NCT03161015|"~     A Phase 1, multiple center, nonrandomized, open-label, parallel group study of a single oral~     dose of GBT440 administered in subjects with mild, moderate, or severe renal impairment~     disease and healthy subjects with normal renal function.~   "
31033|NCT03160846|"~     The INTERPRET Inotrope Evaluation and Research Patient Registry is a longitudinal,~     observational study designed to look at the demographics and outcomes of heart failure~     patients on inotropic therapy administered in the home or infusion suite setting. The data~     gathered in this registry will provide information on how a patient's quality of life and~     symptoms change over time while on inotrope therapy, and help healthcare providers to have a~     better understanding of the benefits and risks associated with bridge-to-treatment and~     palliative care.~   "
31021|NCT03161002|"~     It is general that there are many factors for individual differences of drugs in clinical~     application, of which genetic factors accounted for more than 20%. Ticagrelor is a new-type~     receptor antagonist of P2Y12 and it is not affected by the influence of CYP2C19 polymorphism.~     With lack of predicted biomarkers, especially the research data of Chinese, it has the~     important significance in studying individual differences of ticagrelor in the antiplatelet~     efficacy and safety, through the pharmacogenomics research.~      The aim of this study is to determine the polymorphism of drug metabolizing enzymes, drug~     transporters and drug target genes in Chinese population. By detecting the gene polymorphism,~     we intend to study the pharmacokinetic/ pharmacodynamics/ pharmacogenomics (PK-PD-PG)~     correlation of ticagrelor and provide scientific basis for accurate medication guide for~     people to use ticagrelor.~   "
31022|NCT03160989|"~     The study will evaluate the variability of blood pressure in postmenopausal and hypertensive~     women after only one session and after training of ten weeks of combined physical exercises~     (aerobic and resisted).~   "
31023|NCT03160976|"~     The aim of this study is to analyze the effects of a single session of cryolipolysis on~     localized adiposity on women's abdomen. This is a randomized controlled clinical trial that~     will include 28 women who will be randomly allocated into two groups: Control Group or~     Intervention Group. The following assessments will be performed in both groups:~     ultrasonography and body composition at baseline and 30, 60 and 90 days after randomization~     and blood analysis at baseline and 15 and 30 days after randomization. The expected main~     result at the end of this study is the reduction of the local subcutaneous fat tissue.~   "
31024|NCT03160963|"~     We will determine when to transition from the common vertical jump to chair stand depending~     on age and physical activity levels.~   "
31025|NCT03160950|"~     A single arm non-blinded study is planned to evaluate the durability of the crowns fabricated~     using a novel composite based material, LuxaCrown (DMG, Germany). The durability of these~     crowns will be assessed for anatomical form, marginal adaptation, color match, marginal~     discoloration, surface roughness, secondary caries, pulpal compatibility, plaque index and~     modified papillary bleeding index with intensive follow up for 2 years (at 1 week, 3rd, 6th,~     12th, 18th and 24th month), and then a yearly follow-up for additional 3 years (at 36th, 48th~     and 60th month).~      A total of 50 patients will be selected and one tooth per subject will be included. For the~     purpose of study only the healthy adult patients with age range of 25 - 60 years who would be~     requiring Single crown restoration in the permanent anterior / posterior teeth, either due to~     caries, pulpal involvement or trauma, will be selected. Teeth that require endodontic~     treatment shall be included in the study only after successful endodontic therapy has been~     completed by an experienced endodontist. For broken teeth, only the teeth with > 1/2 crown~     structure remaining or in case of teeth with <1/2 crown structure fractured that can be~     restored with conventional post and core will be selected. In general, patients with bruxism,~     or with severe periodontal disease, mobility grade 2 or 3 shall be excluded from the study.~   "
31026|NCT03160937|"~     The purpose of this study was to assess the acute effects of a single NM treatment session on~     DOMS and to compare them with those of one foam roller (FR) session. Following the damaging~     plyometric exercise bout, the participants were randomly assigned in a counter-balanced~     fashion to either a FR or NM treatment group; treatments were administered 48-h~     post-exercise. The dependent variables were recorded before the exercise, 48-h post-exercise~     before treatment, and immediately post-treatment.~   "
31027|NCT03160924|"~     Over the past two decades, fast track surgery, also known as enhanced recovery after surgery~     (ERAS) has been initiated and developed in colorectal surgery by Kehlet. The program is~     rapidly gaining popularity due to the significant benefits demonstrated in lowering~     complication rates and reducing hospital stay and costs. The benefits demonstrated in~     colorectal surgery by randomized trials and meta-analyses reduced pain, morbidity and~     hospital stay. Data in gastrectomy however, is scarce. Therefore the aim of this study is to~     compare the outcomes of laparoscopic gastrectomies with two different perioperative~     approaches, the traditional and the ERAS approach in a setting of a randomised controlled~     trial.~   "
31028|NCT03160911|"~     Non-variceal acute gastrointestinal bleeding is a common and potentially life-threatening~     problem. The conventional treatment of this condition is for esophagogastroduodenoscopy (OGD)~     for haemostasis. Treatment methods include heater probe, clipping and injection of~     adrenaline. Recently, a new device called the Over-the-scope clip (OTSC) has been device to~     treat perforations and bleeding in the gastrointestinal tract. Therefore, the aim of the~     study is to compare between the treatment outcomes between OTSC and conventional endoscopic~     haemostatic methods in ulcers that are of high risk for rebleeding.~   "
31029|NCT03160898|"~     The purpose of this study is to assess the effect of CK-2127107 versus placebo on respiratory~     function and other measures of skeletal muscle function in patients with ALS.~   "
31030|NCT03160885|"~     Primary objective:~      To evaluate the efficacy of tralokinumab compared with placebo in treating moderate to severe~     AD.~      Secondary objectives:~      To evaluate the efficacy of tralokinumab on severity and extent of AD, itch, and health~     related quality of life compared with placebo.~      Maintenance objective:~      To evaluate maintenance of effect with continued tralokinumab dosing up to 52 weeks compared~     to placebo for subjects achieving clinical response at Week 16.~   "
31031|NCT03160872|"~     To evaluate if ovarian reserve (measured by means of anti-mullerian hormone -AMH- and antral~     follicle count -AFC-) can predict pregnancy in donor insemination cycles (dIUI) performed in~     non-infertile women.~   "
31032|NCT03160859|"~     This is a study to compare two different, but normally, used methods of colonoscopy in~     patients undergoing colonoscopy without sedation. There will be two arms in this study: WE~     (water exchange) control, and WE (water exchange) plus cap (placed at tip of the~     colonoscope). The patient will prepare himself/herself for the colonoscopy as per normal~     instructions and he/she will be given the information for the study at that time so that~     he/she can make a decision to participate in the study. The control method will use water~     instead of air during insertion of the colonoscope. The study method will use a cap that will~     fit onto the end of the colonoscope plus water during insertion of the colonoscope. This~     study will assess if the study method is less painful than the control method.~   "
31034|NCT03160833|"~     This is a dose escalation study consisting of two stages: Dose-escalation stage (stage 1):~     Patients will take a single dose of HMPL-453 on Day 1 and will be followed for one week for~     safety observations. After one week of observation, if no safety issues occur, patients can~     continue multiple dosing of HMPL-453 QD (quaque die) and start on the DLT (Dose Limited~     Toxicity) assessment cycles. Each cycle consists of 28-days. Patients are required to draw~     blood samples for PK and safety analysis at specific time points during the treatment;~     Dose-Expansion Stage (Stage 2): This stage is to further evaluate the safety, tolerability,~     PD (pharmacodynamics) profile, and preliminary anti-tumor activity of HMPL-453 at the RP2D~     (recommended phase 2 dose) in approximately 10 patients with advanced solid tumor.~   "
31035|NCT03160820|"~     This study will evaluate the immunogenicity and safety of Beijing Tiantan's MMR vaccine in~     subjects 18 months of age and older. The MMR vaccine may be administered as a second dose to~     4-6 year-old persons with one dose immunization with MMR vaccine or as a first dose to 18~     month-old subjects with one dose immunization with measles-rubella(MR).~   "
31036|NCT03160807|"~     Study is planned to evaluate safety and efficacy of Levolet in patients with complicated UTI~   "
31037|NCT03160794|"~     In the clinical scenario of recurrent prostate cancer (PCa) post local therapy, current~     standard studies (bone scan and computed tomography) commonly fail to identify the recurrent~     disease location. In this study the investigator aims to prospectively map recurrent disease~     with the unique combination of whole-body MR anatomical imaging combined with a new~     high-sensitivity and PCa-specific PET probe (PSMA-targeted: [18F]DCFPyL) to provide precise~     localization information to target disseminated tumor deposits in men presenting with rising~     PSA after prostatectomy and radiotherapy (maximal local therapies). Moreover, we will~     consequently treat all identified disease with image-guided stereotactic ablative~     radiotherapy (SABR), which has shown tantalizing results achieving excellent tumor~     eradication rates with minimal toxicities. This study is uniquely positioned to enable the~     discovery of new biomarkers and the correlation of prognostic tests (e.g. genomic signatures)~     from the initial prostatectomy specimen with the PET/MR imaging results and SABR treatment~     outcomes.~      The significance of the proposed work towards a measurable impact in PCa care is important to~     emphasize. The study team believes this novel curative-intent approach will transform lives,~     as opposed to therapies that transiently impact incurable disease stages. Herein, the focus~     is on patients at the earliest point of the disease spectrum of recurrent PCa after~     curative-intent treatments. Our hypothesis is that PSMA-targeted [18F]DCFPyL PET/MR allows~     earlier detection and localization of defined metastatic targets in these patients, at a~     stage amenable to image-guided curative-intent therapy.~   "
31038|NCT03160781|"~     The aim of this study was to assess a novel approach to treating severe knee osteoarthritis~     by targeting synovialmembrane, superficial articular cartilage, synovial fluid, and~     subchondral bone by combining intra-articular injections and intraosseous infiltrations of~     platelet rich plasma.This study explored a new strategy consisting of intraosseous~     infiltrations of platelet rich plasma into the subchondral bone in combination with the~     conventional intra-articular injection in order to tackle several knee joint tissues~     simultaneously.~   "
31039|NCT03160768|"~     Expression of the cell cycle regulator p16INK4a increases with age and toxic stressors. In~     mice, both radiation and chemotherapy are known to increase p16. Due to its influence on~     age-related regenerative capacity, p16 is an excellent candidate biomarker of physiologic~     reserve that may identify patients able to withstand the stressor of chemotherapy (low p16)~     from those unlikely to tolerate chemotherapy (high p16). That is, expression of p16 may~     predict physiologic, rather than chronologic, age. Such findings could have implications for~     care of cancer survivors and treatment decision-making in cancer patients.~      STUDY OBJECTIVE: This is an observational pilot study to determine the feasibility of~     isolating p16INK4a in CD3+ T lymphocytes in adults treated with chemotherapy for cancer~     during childhood.~   "
31040|NCT03160755|"~     Specific Aim #1: To identify, through qualitative research, deficits in positive emotional~     states (e.g., positive affect, optimism) and associated barriers to completing health~     behaviors, like physical activity and healthy eating, in patients with metabolic syndrome~     (MetS).~      Hypothesis: Participants will be able to complete semi-structured interviews, providing~     information about their positive emotional states, linking the presence of positive emotions~     to better adherence to health-related behaviors, and identifying additional barriers (e.g.,~     logistic, motivational) to completing such behaviors.~   "
31041|NCT03160742|"~     The goal of this research study is to determine the feasibility and accuracy of Mespere Life~     Science non-invasive central venous pressure monitoring system (Mespere VENUS 2000CVP system)~     in children with congenital heart disease (CHD).~   "
31042|NCT03160729|"~     The aim of this study is to investigate the effect of a single preoperative high-dose steroid~     injection on complications in the immediate postoperative phase after open kidney surgery~     (kidney resection, heminephrectomy, nephrectomy). Primary outcome is complications in the~     post anaesthesia care unit (PACU). Secondary outcomes are organspecific complications in the~     post anaesthesia phase, pain and nausea the first 5 days, seroma and wound infection the~     first 14 days and readmissions the first 30 days after surgery.~      The investigators hypothesize that the frequency of transfer to the PACU and organspecific~     complications will be lower among patients receiving high dose dexamethasone. The~     investigators hypothesize, that there will be no difference in wound infections, seroma or~     readmissions.~   "
31043|NCT03160716|"~     This is a multi-center, open-label, single-arm study to evaluate an injection tool with~     Restylane Lyft with Lidocaine for cheek augmentation and correction of age related midface~     contour deficiencies.~   "
31044|NCT03160703|"~     The purpose of this study is to evaluate and compare the stain build up of two stannous~     fluoride (SnF2) / sodium tripolyphosphate (STP) dentifrices of differing abrasivity levels,~     with a marketed standard fluoride dentifrice and a marketed SnF2 dentifrice.~   "
31045|NCT03160690|"~     Prospective and observational study to determine if choroidal thickness increases after non~     penetrating deep sclerectomy in patients with open angle glaucoma~   "
31046|NCT03160677|"~     A randomized, multicenter study comparing two strategies: 1 / standard management of systolic~     blood pressure according to international recommendations (systolic blood pressure <185 mm~     Hg) versus 2 / intensive blood pressure management Systolic with a target <130 mm Hg.~   "
31048|NCT03160651|"~     Approximately 50% of patients admitted for severe AH will have spontaneous improvement of~     liver function before initiation of therapy (ie decrease in mDF between hospital admission~     and initiation of steroids). These patients have a better prognosis than patients without~     spontaneous improvement of liver function. It has never been demonstrated that~     corticosteroids improve survival in severe AH patients with spontaneous improvement of liver~     function. Our hypothesis is that severe AH patients with spontaneous improvement of liver~     function represent a group who could most benefit from steroids~   "
31049|NCT03160638|"~     Rationale:~      Treatment in tuberculosis (TB) is focused on eradication of the bacterial infection, however,~     after treatment approximately half of patients are left with a significant and permanent~     respiratory impairment. Adjunctive host-directed therapies are being investigated to modulate~     host immune responses to target mycobacterium tuberculosis (Mtb) infection and/or reduce~     excessive inflammation, prevent pathological tissue damage, preserve lung function and~     enhance effectiveness of standard drug therapy, while nonetheless eliminating Mtb. Macrolide~     antibiotics have previously been used in the treatment of multidrug-resistant TB. In addition~     to their antibiotic effects, macrolides have also been recognized to induce anti-inflammatory~     and immunomodulatory effects in other lung diseases.~      Objective:~      To investigate the immunomodulatory effects of azithromycin in tuberculosis patients~     receiving standard therapy (isoniazid, rifampicin, pyrazinamide, ethambutol (HRZE))~      Study design:~      A prospective, randomized open label intervention trial to investigate the immunomodulatory~     effects of azithromycin~      Study population: 24~      Intervention: azithromycin 250 mg once daily or standard of care (control)~      Main study parameters/endpoints:~        1. To assess whether azithromycin enhances resolution of systemic inflammation in patients~          with drug susceptible pulmonary TB receiving standard treatment.~        2. To assess whether azithromycin on top of standard treatment in patients with drug~          susceptible pulmonary TB reduces airway inflammation and reduces tissue degradation and~          remodeling~        3. To investigate whether these effects are associated within shortening of the time to~          sputum conversion.~   "
31050|NCT03160625|"~     RESPOND-HF is a prospective, multi-center, non-significant risk pilot study with cross-over~     design. The purpose of the study is to investigate if rate adaptive pacing has the potential~     to provide benefit to HF patients with preserved ejection fraction, referred to as HFpEF~     patients. Findings from this pilot study may be used to guide subsequent efforts to design~     and conduct a prospective, randomized, multi-center pivotal trial powered to show improvement~     in patient outcomes.~   "
31051|NCT03160612|"~     The objective of this research study is to 1) evaluate the effectiveness of web based~     transfer training materials for wheelchair users and 2) determine the reliability of a~     refined transfer assessment instrument (TAI) as completed by individuals who use wheelchairs~     for a majority of mobility and clinicians who score transfers in-person and remotely.~   "
31052|NCT03160599|"~     Malignant gliomas are the most common type of brain tumor. Standard therapy for glioblastoma~     multiforme (GBM) includes surgery followed by radiation and chemotherapy. Despite optimal~     treatment the prognosis remains poor. There is an urgent need for more effective therapies.~     The Warburg effect has been widely observed in human cancers. The main energy supply of tumor~     cells are aerobic glycolysis. Therefore, they are highly dependent on glucose metabolism.~     Recently, some scholars have suggested that 'Restricted calorie Ketogenic Diet (RKD)' might~     be able to inhibit glycolysis and thus anti-tumor by restricting carbohydrate intake. This~     will 'starve' cancer cells, which will lead to cell death. There are many animal and in vitro~     studies shown that RKD can reduce the tumor size and thus tumor cell growth of malignant~     glioma in mice. However, a consistent positive result can not be found within a small sample~     of clinical trials. In this study, 50 patients with malignant glioma will be treated with or~     without RKD. The safety and efficacy of RKD and the patients' tolerance will be observed in~     order to understand whether this therapy can be a potential new treatment of malignant glioma~     in the brain. This clinical study is comparatively large internationally. It is the first~     domestically. If it is successful, it can be applied to other areas of tumor. This study is~     essential to extend the survival of patients with malignant glioma, and to study clinical~     nutrition support and its metabolic pathways for malignant tumor.~   "
31053|NCT03160586|"~     Stuttering was defined as a common neurodevelopmental speech disorder characterized by~     repetitions, prolongations, and interruptions in the flow of speech. In other words,~     stuttering is a speech disorder characterized by involuntary disruptions to speech which~     impede the capacity to communicate effectively.~      Physiological and emotional anxiety has been reported in persons who stutter. It has been~     reported that as high as 44% of clients seeking treatment for stuttering could be assigned a~     co-occurring social phobia or social anxiety diagnosis.~   "
31054|NCT03160573|"~     The purpose of this Study is to assess the efficacy of two ClōSYS Oral Rinse products in~     human subjects in controlling oral malodor in partial fulfillment of the requirements for~     recognition by the American Dental Association's (ADA) requirement for obtaining ADA Seal for~     malodor.~   "
31055|NCT03160560|"~     The purpose of this Study is to assess the efficacy of two ClōSYS Oral Rinse products in~     human subjects in controlling oral malodor in partial fulfillment of the requirements for~     American Dental Association's (ADA) requirement for obtaining ADA Seal for malodor.~   "
31056|NCT03160547|"~     The investigator will investigate the effects of higher protein/amino acid dosing (≥2.2~     g/kg/d) vs lower protein/amino acid dosing (≤1.2 g/kg/d) on clinical outcomes in~     nutritionally high risk ill patients.~   "
31057|NCT03160534|"~     This study evaluates the effect of preoperative exercise in patients undergoing a total knee~     arthroplasty.~   "
31058|NCT03160521|"~     This is a multicenter, randomized, double-blind, placebo-controlled study designed to~     evaluate the efficacy and safety of intramuscular (IM) injections of Risperidone ISM® (75 or~     100 mg) or placebo, in patients with acute exacerbation of schizophrenia.~   "
31059|NCT03160508|"~     This study documents real life weight bearing in patients treated with a TFNA, who are~     allowed for immediate weight bearing as tolerated.~   "
31060|NCT03160495|"~     The purpose of this study is to investigate if heterogeneity in head and neck squamous cell~     carcinoma as seen in functional imaging with PET/MR can be correlated to biologic~     heterogeneity in surgical specimens.~   "
31063|NCT03160456|"~     The aim of this study is to assess the efficacy of transcutaneous electrical stimulation of~     the pharyngeal dilator muscles in patients with obstructive sleep apnoea in the community~     compared to usual care, and follow the patients for 3 months, as well as to assess compliance~     of non-invasive electrical stimulation of the upper airway dilator muscles in obstructive~     sleep apnoea patients over time and evaluate the control of symptoms and improvement in~     quality of life.~   "
31064|NCT03160443|"~     Eating disorders are multifactorial disorders currently conceptualized in a biopsychosocial~     model, but pathophysiology remains relatively unknown, and robust etiological models to guide~     treatment are therefore lacking. Different endophenotypes and neurocognitive vulnerability~     factors have been found in eating disorders including decision making abnormalities. The~     investigators hypothesize that decision making abnormalities are associated with a lower~     level of functioning and quality of life which could lead to social and interpersonal~     difficulties. The investigators also hypothesize that these anomalies are associated with a~     particular clinical profile (more restrictive profile, more hyperactivity, less insight on~     the disease and desire for care ...).~   "
31065|NCT03160430|"~     This is a multi-center, two-part study; Part A and Part B. Part A of the study is an~     open-label, single-dose pharmacokinetic (PK) evaluation of 100 mg RVX000222 on dialysis and~     non-dialysis days in eight (8) End Stage Renal Disease (ESRD) patients who receive~     hemodialysis as standard of care.~      Part B of the study is a double-blind, placebo-controlled study in up to thirty six (36) ESRD~     patients receiving hemodialysis using a sequential cross-over design with RVX000222 at a~     daily oral dose of 100 mg b.i.d. (200 mg per day) or matching placebo in combination with~     SoC.~      The primary objective of the study is to evaluate if treatment with RVX000222 in combination~     with standard of care (SoC) decreases plasma alkaline phosphatase in comparison to placebo~     and SoC.~   "
31066|NCT03160417|"~     The aim of the study is to describe CBF modifications during rewarming after targeted~     temperature management in cardiac arrest patients~   "
31067|NCT03160404|"~     Introduction: The prevalence of chronic insomnia in the general population is 10 to 15%. The~     therapy commonly prescribed for its treatment is pharmacological, however, there are several~     non-pharmacological therapies being studied, among them physical exercise. Although some~     studies have described the effect of exercise on the promotion of sleep in insomnia, no~     studies comparing exercise and drugs in the treatment of insomnia, or its effect as~     coadjuvant therapy, have been performed.~      Objective: To compare the effects of regular aerobic exercise (12 weeks) with pharmacological~     therapy (zolpidem, 10mg / night) or combined therapy (exercise + pharmacological therapy) on~     sleep quality, mood and quality of life of patients with chronic insomnia.~      Material and Methods: 45 patients with chronic insomnia will be randomly assigned to three~     groups: aerobic exercise (GEA), pharmacological therapy (GTF) and combined therapy (GTC). The~     GEA group will participate in an aerobic exercise program for 12 weeks, performed in~     intensity relative to 50% of reserve heart rate, on a treadmill. The GTF group will be~     treated with zolpidem 10mg / night and the GTC will be treated with zolpidem 10mg / night and~     will participate in the aerobic exercise program. For sleep evaluation will be used the~     polysomnography, actigraphy, sleep diary and questionnaires. Mood and quality of life will be~     investigated through questionnaires.~      Hypothesis: Considering previous studies have demonstrated positive effects of aerobic~     exercise in the insomnia symptoms, the hypothesis of this study is aerobic exercise,~     performed at moderate intensity, can control the symptoms of chronic insomnia similar to~     pharmacological therapy, and when combined with it, can accentuate its effects, also~     contributing to improvements in patients' mood and quality of life.~   "
31068|NCT03160391|"~     The study used a randomized controlled trial to test the efficacy of two interventions (dance~     and musical training) for typically developing children. Interventions were run for three~     weeks in local community locations. Participants were tested before and after the~     intervention on a battery of cognitive and behavioural measures. They were compared across~     groups, and to a control group who do not receive the intervention.~      The purpose of the current study was to assess the influence of dance and musical training on~     cognitive development. Research has indicated that musical training is associated with~     improve cognitive functioning, although the direction of such an association is unclear.~     Further, it is uncertain whether any benefits are specific to musical training or can also be~     demonstrated with other training activities. The current study used a randomized controlled~     trial to assess the causal effects of dance and musical training.~   "
31069|NCT03160378|"~     The purpose of this trial is to investigate the effect of organizational skills training, a~     parent and child training approach on organizational skills, inattentive symptoms and~     functional outcome in children age 6-13 years. Half of the participants will receive~     treatment as usual (TAU) and organizational skills training and the other half will receive~     TAU.~   "
31070|NCT03160365|"~     A key feature of low-dose brachytherapy is that irradiation affects only a local area around~     the inserted radiation sources. The exposure of healthy tissues around these sources is then~     reduced. However, the number of adverse events remains high (about 79% of patients with~     sexual problems and 30% of patients with urinary incontinence) and brachytherapy is no better~     than other treatment options for Preservation of the urethral apparatus (about 40% of~     patients).~      The current technique for the implantation of radioactive sources, which has not been revised~     since the early 1980s, consists in imaging the prostate at the beginning of the~     intraoperative procedure with transrectal ultrasound in order to evaluate the size and shape~     of the prostate . This information is then used to identify the best distribution of the dose~     of radiation to be administered to each patient. This treatment planning step is based on a~     procedure where the operator manually places 50 to 100 grains of iodine in the prostate.~     These grains are inserted transperinally under transrectal 2D ultrasound control, using~     needles through a transperineal grid with several needle guides evenly spaced 5 mm apart.~     This is an arduous task because this manual grain placement procedure must take into account~     the dose to be administered to the prostate without exceeding the dose limit for the~     surrounding organs at risk (rectum, urethra). In addition, the overestimation of the dose~     formality called TG-43 and the inaccurate grain placement can contribute to the creation of~     cold spots where no dose is administered. It may be responsible for recurrences of prostate~     cancer after brachytherapy treatment. Although brachytherapy dosimetry has been extensively~     researched, the TG-43 dose formalism has been the benchmark for the last 20 years. Moreover,~     from an economic point of view, the high side-effects rates of the treatment of prostate~     cancer result in particularly expensive post-treatment costs. The search for improved~     solutions for the treatment of prostate cancer remains a major societal challenge.~      In recent years, a very attractive therapeutic alternative between active surveillance and~     overall treatment is gaining popularity among experts: focal therapy.~      It is a localized treatment, limited to cancerous areas, in order to preserve healthy~     functional tissues inside and outside the organ and thus the quality of life of the patient.~      Focal therapy is also often the preferred solution for recovery therapy (second~     intervention).~      Finally, focal therapy has great potential to reduce the cost and duration of the~     intervention, as well as the cost of follow-up.~      In recent years, several energies have been proposed as being adapted to focal therapy, such~     as high intensity focal ultrasound, laser ablation and cryotherapy. Brachytherapy, which~     already gives above average results in the treatment of whole glands, has been identified as~     a very good candidate for this new therapeutic paradigm.~      In brachytherapy, radioactive grains are implanted in the prostate using transperineal~     catheters. The rapid reduction of the dose according to the distance of the radioactive seeds~     gives the physician a great flexibility to control the radiation accurately. It allows~     intermediate approaches between global and focal treatments, providing great scalability, and~     it is a good candidate for recovery therapy.~      Recent studies have shown that focal brachytherapy allows more than half of the needles and~     seeds to act more strongly on the target while irradiating Significantly less The urethra and~     rectum. Clinical studies on this subject are still limited and further research is needed to~     confirm the performance of this approach.~   "
31071|NCT03160352|"~     The aim is to assess the effects of virtual reality-based intervention on vestibular~     functions in healthy community dwellers.~   "
31072|NCT03160339|"~     PXVX0047 (Adenovirus Type 4 and Type 7 Vaccine [A549 Cells], Live, Oral) is an~     investigational vaccine in development for the indication of active immunization against~     adenovirus infection. The primary goals of this Phase 1 study are to evaluate safety,~     pharmacodynamics (viral shedding), and immunogenicity of PXVX0047.~   "
31073|NCT03160326|"~     Currently there is no standard way to detect age-related skeletal muscle loss in patients~     with chronic kidney disease. Investigators are working on finding rapid and inexpensive ways~     to measure muscle size and fat within the muscle.~   "
31074|NCT03160313|"~     This study will evaluate feasibility and preliminary effectiveness of a 10-week~     interdisciplinary and multimodal intervention that utilizes patient education, group~     discussion, and supervised exercise for Veterans with a history of traumatic brain injury~     (TBI). Primary outcomes include physical activity (PA), sleep quality, and community~     integration.~   "
31075|NCT03160300|"~     This study evaluates the effect of binaural beats on pain perception and subsequent need for~     analgesic medication use in patients suffering from diseases causing chronic pain. All~     patients will receive two consecutive interventions: binaural beat signals embedded in~     relaxing music and placebo (relaxing music without the binaural beat component), in random~     order.~   "
31076|NCT03160287|"~     More than 50% of older persons with osteoarthritis (OA) experience disrupted sleep and~     insomnia symptoms of difficulty falling asleep, awakening during the night, and awakening too~     early and being unable to fall back to sleep. Because OA pain has been implicated in sleep~     problems and because physical exercise interventions have been found to improve pain and~     sleep quality, staying physically active during the daytime is likely advantageous in terms~     of improving sleep. Physical exercise interventions with a duration between 10 and 16 weeks~     have been shown to improve quality of sleep in older adults with self-reported disrupted~     sleep. Unfortunately, recent reports show that older adults with OA are mainly sedentary and~     few meet national guidelines for recommended amounts of daily physical activity. A~     self-management intervention that integrates use of mobile technology to prompt older adults~     to be physically active, provides ongoing monitoring of the amount of their physical activity~     and includes self-efficacy enhancements is a novel non-pharmacological intervention both for~     prevention and treatment of sleep deficiency in persons with OA.~      The proposed study will involve delivery of automatic physical activity-focused text~     messages, a novel sleep self-management diary (SleepTight) and motivational interviewing in~     participants with OA of the hip or knee (most commonly affected joints). The purpose of this~     Project is to pilot test a new self-management program: MobMPATI, a multidimensional,~     tailored intervention for sleep deficiency in for older adults with OA. The specific aims are~     to:~        1. Test the acceptability of MobMPATI for older adults with OA and poor sleep quality as a~          manifestation of sleep deficiency.~        2. Test the feasibility of implementing MobMPATI for older adults with OA, as well as~          collecting electronic data from the sample.~        3. Explore pre/posttest changes in self-efficacy, motivation and sleep deficiency measures~          [total sleep time (TST) and sleep efficiency (SE)] with the MobMPATI intervention.~      This study will provide feasibility/acceptability and preliminary data necessary for a larger~     clinical trial of MobMPATI intervention to encourage physical activity and reduce sedentary~     behavior in older adults with OA as a way of reducing sleep deficiency. Preliminary testing~     of the intervention will indicate what measures are more sensitive in promoting self-efficacy~     and motivation so that a smaller number of outcomes could be monitored to reduce participant~     burden. This study is the first step in this innovative program of research. The knowledge~     gained will provide data on the benefit of a potentially cost-effective intervention that~     could be implemented on a large scale to improve health of older adults with OA.~   "
31077|NCT03160274|"~     Pheochromocytomas and paragangliomas are neural crest-derived tumors of the nervous system~     that are often inherited and genetically heterogeneous. Genetic screening is recommended for~     patients and their relatives, and can guide clinical decisions. However, a mutation is not~     found in all cases. The aims of this proposal are to: 1) to map gene(s) involved in~     pheochromocytoma, and 2) identify genotype-phenotype correlations in patients with~     pheochromocytoma/paraganglioma of various genetic origins.~   "
31078|NCT03160261|"~     The primary aim of the study is to describe the effect of single dose of 10 micrograms (μg)~     exenatide given subcutaneously (s/c) on cortisol secretion. Secondary outcomes involve ACTH~     and glucose levels.~   "
31079|NCT03160248|"~     This is an investigator-initiated, single-center, prospective, randomized, double-blind,~     interventional phase IIb study. Forty patients with clinically and histologically confirmed~     nummular eczema will be enrolled according to inclusion and exclusion criteria. Patients will~     be included after written informed consent is obtained. Prior to randomization, average~     application rate of class II topical steroids per day will be measured for 4 weeks.~     Subsequently, patients will be randomized in a 1:1 ratio into one arm to receive Apremilast~     30 mg BID (following titration phase) for 16 weeks or a second arm receiving identically~     matching placebo for 16 weeks. From beginning of week 17, all patients will start an~     open-label treatment with Apremilast 30 mg BID until week 32. Concomitant use of topical~     steroids (class II) is allowed during the study. During the treatment period both placebo and~     Apremilast will be applied p.o. from week 0 until week 32.~   "
31080|NCT03160235|"~     Studies that will be carried out on healthy volunteers will have as main objective the~     development and optimization of the parameters of sequences or the design of the paradigms of~     stimulation in order to optimize the quality and the relevance of the images realized taking~     in Taking account of anatomical, functional or metabolic parameters, or integrating new~     approaches resulting from technical evolutions~   "
31081|NCT03160222|"~     The prospective study will include 200 patients and 50 critically ill patients, who had an~     abdominal computed tomography (CT) scan including the L3 level for any clinical reason.~     Ultrasound scans of the anterior thighs and forearms will be taken after the CT scan within~     48 hours. Bioelectrical impedance analysis (BIA) will also be performed. In addition muscle~     strength, mobility, physical function and nutrition will be assessed. Primary outcome is the~     prediction of CT-based whole body muscle and fat volume and BIA-based fat and lean body mass~     from ultrasound-based muscle and fat thickness. Other secondary outcomes include the intra-~     and interrater reliability of the CT evaluation and ultrasound examination of muscle and fat~     mass. The relationship between clinical aspects (strength, mobility, physical function,~     nutrition) and whole body composition is another secondary outcome.~   "
31082|NCT03160209|"~     The primary purpose of this single-center, case-control, non-interventional study is to~     determine risk factors which contribute to the development of esophageal squamous cell~     carcinoma (ESCC) at Kamuzu Central Hospital (KCH) and St. Gabriel Hospital (SGH) in Malawi.~   "
31083|NCT03160196|"~     To assess the efficacy of an electronic system to support clinical decisions based on an~     evidence-based clinical practice guide for metabolic control of adults with Type 2 Diabetes~     Mellitus through Clinical and cluster-randomized controlled trial in a Colombian population.~   "
31084|NCT03160183|"~     The purpose of this study is to identify important associations between complete and~     comprehensive clinical, laboratory, and genomic data derived from patients and tumor~     specimens, with prospectively recorded clinical outcomes. The investigators also hope to move~     beyond simple risk factor associations as previously described, to develop a composite score~     specifically for KS recurrence or progression, analogous to widely used risk scores that are~     used to direct up-front treatment of other cancers. In so doing, the investigators will draw~     on extremely granular data to prospectively identify patients who are most likely to benefit~     from new treatments.~   "
31085|NCT03160170|"~     This is a prospective randomized controlled trial of the Suction-Integrated Surgical Tissue~      Elevator & Retractor [SISTER] device to assess:~        -  Effects on operative time and efficiency of exposure in open lumbar spine cases.~        -  Effect on total blood loss during the exposure part of the operation.~        -  Rate of clogging of suction device.~   "
31093|NCT03160066|"~     Emerging evidence suggests that microorganisms acting via the Brain-Gut axis may have~     potential benefits for the management of stress-related conditions. The majority of studies~     have focused on animal models. Preclinical studies have identified the Lactobacillus~     Rhamnosus JB-1 strain as a putative psychobiotic with an impact on stress-related behaviours,~     physiology and cognitive performance. Whether such preclinical effects could be translated to~     healthy human volunteers remains unknown.~   "
31094|NCT03160053|"~     Treatment of keloids with targeted Ultraviolet-Beta (UVB) radiation will improve the clinical~     appearance and induration of lesions.~   "
31095|NCT03160040|"~     This study is a retrospective, observational study to evaluate minocycline use in~     participants under real world conditions.~   "
31086|NCT03160157|"~     This research is being done to examine which minimally invasive surgical approach is~     associated with the best outcomes when performing cholecystectomy surgery: laparoscopic or~     robotic?~      Laparoscopic and robotic approaches are similar surgical procedures using small incisions.~     The laparoscopic approach is largely used for the removal of the gallbladder~     (cholecystectomy).~      At UIC, the investigators perform the majority of the gallbladder surgeries through the~     robotic approach and only a few using the laparoscopic approach. The robotic surgical tools~     allows the surgeon the same freedom of movement as a human wrist, while using a 3D camera~     view.~      The laparoscopic and robotic surgical approaches both represent minimally invasive surgery~     approach and are associated with less pain, faster recovery and better cosmetic outcomes when~     compared to traditional open surgery. It is not currently known which approach is better.~   "
31087|NCT03160144|"~     Postoperative Pulmonary Complications (PPC) are very common. It severely affects~     postoperative recovery, particularly in the abdominal surgery. Patients with laparoscopic~     resection of colorectal cancer generally have a higher age and decreased lung function~     reserve. At the same time, they prone to developing atelectasis due to the effects of~     pneumoperitoneum pressure. Therefore, they are a high-risk group of respiratory insufficiency~     and PPC.~      Mechanical ventilation with a low tidal volume is a routine in clinic nowadays. However, this~     conventional strategy will also result in atelectasis formation. Therefore, it may~     deteriorate the vulnerable lung function of patients undergoing laparoscopic resection of~     colorectal cancer. Patients with Acute Lung Injury or Acute Respiratory Distress Syndrome~     (ALI/ARDS) could benefit from the open lung approach, including the use of positive~     end-expiratory pressure (PEEP) and recruitment maneuvers (RMs). Whether a lung protective~     mechanical ventilation strategy with medium levels of PEEP and repeated RMs, the open lung~     approach, protects against respiratory insufficiency and PPC during laparoscopic resection~     of colorectal cancer is uncertain. The present study aims at comparing the effects of open~     lung approach mechanical ventilation strategy and conventional mechanical ventilation~     strategy in PPC, extra-pulmonary complications, length of hospital stay, biomarkers of lung~     injury and changes of respiratory function in patients undergoing general anesthesia for~     laparoscopic resection of colorectal cancer.~   "
31088|NCT03160131|"~     In Denmark, about 120,000 people suffer from brain damage, of whom approx. 75,000 with brain~     damage after stroke. Serious and often lasting vision impairments affect 20% to 35% of people~     after stroke. Vision is the most important sense in humans, and even smaller permanent~     injuries can drastically reduce quality of life.~      Vision impairments after brain damage inhibits rehabilitation and enhances other invalidating~     effects. Reduced vision results in impaired balance, increased risk of serious falls,~     increased support needs, reduced quality of life, and impaired ability to perform activities~     of daily living. Restoration of visual field impairments occur only to a small extent during~     the first month after brain damage, and therefore the time window for spontaneous~     improvements is very limited. Hence, brain-impaired persons with visual impairment will most~     likely experience chronically impaired vision already 4 weeks after brain injury and the need~     for visual compensatory rehabilitation is substantial.~      Neuro Vision Technology (NVT) is an supervised training course where people with visual~     impairments are trained in compensatory techniques using special equipment. Through the NVT~     process, the individual's vision problems are carefully investigated and personal data is~     used to organize individual training sessions that practice the individual in coping with~     situations that cause problems in everyday life.~      The purpose of this study is to investigate whether rehabilitation with NVT can cause~     significant and lasting improvement in functional capacity in persons with chronic visual~     impairments after brain injury. Improving eyesight is expected to increase both physical and~     mental functioning, thus improving the quality of life. Participants included in the project~     will be investigated in terms of both visual and mental functions, including quality of life,~     cognition and depression. Such an investigation has not been performed previously and can~     have a significant impact on vision rehabilitation both nationally and internationally.~   "
31089|NCT03160118|"~     This clinical fase IV study, using the administration of a single dose of a quadrivalent,~     inactivated, split influenza virus vaccine as biological intervention will mirror a study~     conducted at Imperial College, London, UK that will use a challenge with live virus as~     intervention. Comparison of the clinical observations and laboratory measurements generated~     in both studies will inform us about the similarities and differences in innate and adaptive~     immune responses elicited by both types of exposure to influenza virus antigen(s).~   "
31090|NCT03160105|"~     The purpose of this study is to evaluate whether maintenance antiretroviral therapy could be~     simplified to DTG + FTC dual therapy and/or patient-centered monitoring once virological~     suppression is achieved. Using a factorial design, the study aims to assess the efficacy of~     DTG + FTC dual therapy to maintain virological suppression through 48 weeks of follow-up as~     well as the costs of a patient-centered ART laboratory monitoring.~   "
31091|NCT03160092|"~     Young people with At Risk Mental State (ARMS) may have changes in their thoughts and the way~     they see or hear things, which they might find odd and distressing. They may be feeling~     tense, worried and low in mood and may not feel like socialising. They may also experience~     difficulties with eating and sleeping. For many people these symptoms might not last for very~     long, but for a small number of people, they might last longer and could become worse (health~     professionals call this psychosis).~      Psychological therapy, which involves talking to a therapist, can help to stop these symptoms~     from getting worse, stopping psychosis. It can also help to make the symptoms better.~     Cognitive Behavioural Therapy (CBT) is the treatment that is most recommended to help young~     people with ARMS. But, this is not always available, can take a long time and is quite~     expensive. Some research has shown that brief therapy with a therapist who is warm and~     understanding and helps the young person to make sense of their symptoms, may be as helpful~     as CBT, and is quicker and cheaper.~      This study hopes to develop a treatment like this and to offer it to 12 young people, aged~     between 16 and 25, who are experiencing the symptoms outlined. Participants will be given~     four treatment sessions, and will be asked to complete some questionnaires. The study aims to~     see how they find it and whether it seems to help them. It will also ask professionals who~     work with these young people what they think about the new therapy. This is a feasibility~     study so the findings will help us to decide whether more research should be done on this~     treatment and whether it could be offered in the NHS in the future.~   "
31092|NCT03160079|"~     This is a Phase I/II study of blinatumomab in combination with pembrolizumab in adult~     patients with relapsed or refractory B-lineage ALL The primary objective of this study is to~     determine if the addition of pembrolizumab to blinatumomab improves the overall response rate~     (CR+ CRh) relative to blinatumomab alone in adult subjects with relapsed or refractory B-cell~     acute lymphoblastic leukemia with high bone marrow lymphoblast percentage (>50%~     lymphoblasts).~   "
44393|NCT02985723|"~     The aim of the present study is to evaluate the postoperative visual acuity for distance,~     intermediate and near vision as well as the cylinder correction and the patient satisfaction~     after bilateral implantation of AT LISA tri toric 939MP IOLs.~   "
31096|NCT03160027|"~     A recent study (Saltmarche et al., 21017) examined the effects of photobiomodulation (PBM), a~     kind of light therapy that uses red or near-infrared light to heal and protect tissue that~     has either been injured, is degenerating, or else is at risk of dying, in 5 older adults with~     dementia. After 12 weeks of PBM treatments, delivered with a commercially available, wearable~     device, the patients with mild to moderately severe dementia showed improvements on the~     Mini-mental State Exam (MMSE, p<0.003) and Alzheimer's Disease Assessment Scale-cognitive,~     ADAS-cog, p<0.03). The caregivers, who kept daily journals of their experiences during the 12~     weeks of PBM treatment, reported better sleep, fewer angry outbursts, decreased anxiety and~     wandering in their loved-ones with dementia. The goals of this trial are to: (1) replicate~     this finding in a larger group of individuals with dementia and (2) to examine the underling~     brain mechanisms behind the changes in cognitive function.~   "
31097|NCT03160014|"~     Comparison of the pharmacokinetics/Pharmacodynamics of the SHR3824 in Patients With Mild,~     Moderate and Severe Hepatic Impairment Compared with Healthy Volunteers.~   "
31098|NCT03160001|"~     Assessment of the adjuvant use Niclosamide With Etanercept in Rheumatoid Arthritis~   "
31099|NCT03159988|"~     Heart failure (HF) is the major cardiovascular disease that continues to grow in prevalence,~     largely due to aging of the population. HF is described as the inability of the heart to keep~     up with the demands on it and, specifically, failure of the heart to pump blood with normal~     efficiency. Cognitive impairment (CI) is common in HF patients, resulting in a person having~     trouble remembering, learning new things, concentrating, or making decisions that affect~     their everyday life. Patients with HF have been show repeatedly to have trouble remembering~     and learning new things when compared to the general population. Patients with demonstrated~     CI have a significantly increased risk of developing dementia (memory loss). It is believed~     that the reason HF patients have a higher risk of CI is possibly due to less blood reaching~     the brain and an overall inflammatory process occurring in the body including the brain. To~     date there are no known therapies that can help treat CI caused by HF.~      A substance, Angiotensin-(1-7) [Ang-(1-7)], is known to decrease inflammation in the brain.~     Early studies in humans have shown it to be safe. This substance is naturally produced in the~     body and works by activating areas in the brain involved in memory. Investigators believe~     that Ang-(1-7) may be able to help lower the risk of loss of cognitive function in patients~     with heart failure.~      In this study, we will try to determine whether Ang-(1-7) is a safe and effective treatment~     for cognitive impairment in HF patients.~   "
31100|NCT03159975|"~     The purpose of this study is to determine the safety, tolerability, and immunogenicity in~     patients with pulmonary tuberculosis of an investigational DNA vaccine being developed for~     the prevention of relapse of tuberculosis.~   "
31101|NCT03159962|"~     the effectiveness of RME (Rapid Maxillary Expander) on the sagittal dental or skeletal~     parameters is still controversial because very little has been written regarding the behavior~     of antero-posterior mandibular changes in Class II growing subjects who underwent RME as the~     phase 1 treatment intervention. The reported significant occlusal improvement could be~     attributed to other reasons, ie, skeletal growth or the use of additional appliances during~     transition from mixed to permanent dentition. Moreover, the majority of the studies show some~     limits: they are not randomized, they are not prospective, and they have no control group or~     they use patients from growth studies as a source for the control group. The primary~     objective of the present investigation was to conduct a pilot randomized controlled trial~     (RCT) evaluating the changes in the antero-posterior mandibular position induced by bonded or~     banded RMEs compared with an untreated Class II control group~   "
31102|NCT03159949|"~     An adapted sprint interval training protocol involving 2-3 repeated 20-second sprints~     separated by 2-3 minutes rest (termed reduced exertion high- intensity interval training~     (REHIIT)) has been developed and has been shown to promote fitness benefits. This data shows~     how little exercise one may need to improve cardiorespiratory fitness, provided they are~     willing to work very hard. However, it is unknown whether the benefits of REHIIT are because~     of the all-out nature of the sprint efforts themselves or the pattern of completing sprints~     with relatively short (i.e., minutes) rest periods within a workout session.~      We are inquiring whether performing the same number and style of sprints with prolonged rest~     (i.e., 1-4 hours of rest in between sprints) is equally effective for improving aerobic~     fitness when compared to more traditional sprint interval training with 2-3 minutes of rest~     between sprints. Such information may make the effectiveness of sprint training more~     accessible and approachable for individuals unwilling or unable to plan a purposeful REHIIT~     exercise session into their day. If the rest interval could be prolonged then it may be~     possible to perform a few sprints as exercise snacks throughout the day without the need~     for a structured interval training session.~   "
31103|NCT03159936|"~     Evaluate the activity and safety of oral tofacitinib in adult patients with discoid lupus~     erythematosus with or without concurrent SLE.~   "
31104|NCT03159923|"~     The aim of this study is to improve the definition of the two main types of secondary~     tricuspid regurgitation.~   "
31105|NCT03159910|"~     Aim: To evaluate the effectiveness of Shoulder-Café (intervention) compared to~     Shoulder-Guidance (control intervention) with respect to shoulder exposures and shoulder~     complaints.~      Hypothesis: The Shoulder-Café, which unifies education, diagnostic clarification, supervised~     and home-based shoulder exercises, and advice from a health and safety consultant on~     workplace interventions, will reduce shoulder exposures and shoulder complaints more~     effectively than an individual-oriented control intervention with home-based shoulder~     exercises and written general advice on workplace interventions.~   "
31106|NCT03159897|"~     The FIL-Rouge is a randomized, open-label, multicenter, phase III, 2-arm study. The primary~     objective is to compare efficacy and tolerability of the intensified variant~     'dose-dense/dose-intense ABVD' (ABVD DD-DI) with an interim PET response-adapted ABVD program~     as upfront therapy in advanced-stage classical Hodgkin Lymphoma (HL).~   "
31107|NCT03159884|"~     To assess the efficacy of intravitreal injection of 0.5 mg conbercept in patients with~     polypoidal choroidal vasculopathy (PCV) and explore the optimal route of administration.~   "
31108|NCT03159871|"~     A Randomized prospective single blinded trial. The investigator seek to evaluate the surgical~     outcome of Stratafix barbed suture compared to standart Vicryl sutures in reducing the~     suturing time during C-Section.~   "
31109|NCT03159858|"~     The FENESTRATED AAA ENDOVASCULAR GRAFT WITH THE H&L-B ONE-SHOT™ INTRODUCTION SYSTEM is~     neither commercially available or available as part of a clinical trial. IRB approval of this~     protocol was requested so that Cook, Incorporated may apply to the FDA for approval for~     one-time use of this patient-specific device for compassionate use for patient AO. It is a~     custom made endovascular device consisting of4 fenestrations for the celiac, SMA (superior~     mesenteric) and left and right renal arteries.~   "
31110|NCT03159845|"~     Patients affected by multiple myeloma undergone autologous stem cell transplantation (SCT)~     are enrolled at the moment of stem cell collection. They are randomized 1:1 in two groups at~     the moment of the graft. Patients of the Control group take only standard antimicrobial~     prophylaxis after SCT; the Sample group takes in addition a daily oral supplementation of~     Zinc Sulfate (600 mg/die) from day +5 until day +100 after SCT. Laboratory tests are~     performed on peripheral blood samples.~   "
31111|NCT03159832|"~     The purpose of the study is to investigate the pharmacokinetics/pharmacodynamics and safety~     of SHR3824 in Type 2 Diabetes Patients with Renal Insufficient.~   "
31112|NCT03159819|"~     A single arm, open-label pilot study is designed to determine the safety, tolerability and~     engraftment of CAR-CLD18 T cells in patients with advanced gastric adenocarcinoma and~     pancreatic adenocarcinoma.~   "
31113|NCT03159806|"~     Patients will be invited to participate from an outpatient nephrology clinic at Hammersmith~     Hospital. They will have a microdialysis catheter inserted into a peripheral vein and~     connected to a sampling system. The samples will be sent for analysis in the hospital~     laboratory. All medical devices to be used are already CE-marked and approved for these~     purposes.~   "
31114|NCT03159793|"~     A huge number of children suffer from anxiety during their dental treatment especially those~     who did not receive any type of behavior management during their first dental visit. This~     will result in a more complicated treatment sessions for the children, dentist and the~     parents. Fear and anxiety control is the key to change the resistant nature of the anxious~     patients and also allow them to receive the proper treatment they require. From the point of~     view that there is no difference between the techniques effectiveness, evaluation of two~     modelling techniques (live modelling and filmed modelling versus no modelling) for children~     anxious behavior management during the dental treatment will be performed.~   "
31115|NCT03159780|"~     Clear-lens extraction has been considered as first-line therapy for primary angle closure~     glaucoma(PACG) and application of toric intraocular lens (IOLs) leads to better postoperative~     visual acuity, yet little is known about the prevalence of corneal astigmatism in PACG~     patients. We intend to make biometry examination for Chinese PACG patients, to obtain~     keratometry (K) , axial length (AL) and so on, and demographics data will also be recorded.~     We will study the prevalence of corneal astigmatism before glaucoma surgery in Chinese~     patients with PACG. Furthermore, differences of corneal astigmatism between primary~     angle-closure glaucoma and cataract patients will be explored. Finally, the prevalence of~     corneal astigmatism before glaucoma surgery in Chinese patients with PACG will be portrayed~     and can be instructive to the IOLs' manufactering.~   "
31116|NCT03159767|"~     This is a clinimetric study to validate the use of IMU spinal sensors to measure the range of~     spinal movement in a group of patients with axial spondyloarthritis.~   "
31117|NCT03159754|"~     When the appendix becomes infected and inflamed, it is called appendicitis. Sometimes, if the~     infection and inflammation get worse, the appendix can die or burst, leading to a larger~     infection or even pus pockets around the appendix. This is called complicated, or perforated,~     appendicitis. Three common treatments for complicated appendicitis are~        -  appendectomy (removal of the appendix) right away~        -  appendectomy several weeks after the diagnosis~        -  treating the appendicitis without performing an appendectomy~      This study seeks to determine which of these three approaches is most cost-effective in~     children with complicated appendicitis.~   "
31118|NCT03159741|"~     Glucagon-like peptide-2 (GLP-2) is a naturally occuring hormone secreted to the circulation~     in response to food ingestion. Previous studies have shown that GLP-2 and incretins inhibit~     the bone resorption. However, the mechanism is unknown. In the present study we will~     investigate the mechanism of action using a receptor specific inhibitor.~   "
31119|NCT03159728|"~     In Colombia as in the world, chronic diseases occupy the first places of death being~     cardiovascular, chronic respiratory diseases and diabetes mellitus are the most prevalent.~     The caregiver burden is reflected as an experience of constant attention, this routine is~     shown in the changes they undergo in their life, and the emotions cope at different stages of~     the process that arises chronic non-communicable disease from their family in demands care.~     Methodology: a randomized controlled trial (RCT) will be conducted to determine the effect of~     skill care program Caring for the caregivers to reduce the burden of care in carers of~     people with chronic non-communicable University Hospital in Los Comuneros in Bucaramanga.~     Results and expected impact: bring to the lines of research: Community Care: improve the~     ability of the care of family caregivers at home and increase the quality of life that people~     are able to chronicity. Clinical Care: Strengthens care ability of caregivers who are in~     health institutions. Management and Care Management: Promoting implementation, monitoring and~     evaluation of the educational proposal in order to create a network of support for family~     caregivers in Santander in extending the results to other institutions. The project results~     should allow participation in Extension and Social Projection, whose results will allow the~     implementation of an effective educational model for the care of patients with chronic~     non-communicable disease in Colombia. In addition, the consolidation of the alliance between~     Everest group at the University of Santander with the Latin American Network of chronic~     patient care and clinical Communards of Bucaramanga projects. Finally it is expected to~     consolidate training in the area of research students in undergraduate and graduate programs~     at the University of Santander.~   "
31120|NCT03159715|"~     The objective of the present project is to study the differential effectiveness of three~     brief self-applied via the Internet interventions for mild to moderate depression: a global~     protocol composed of several therapeutic components (psychoeducation, cognitive~     restructuring, behavioral activation, positive psychology, and relapse prevention), a~     protocol just based on behavioral activation (BA), and a protocol just based on positive~     psychology (PP). The purpose is to know the specific contribution of each therapeutic~     components in the treatment of depression.~   "
31123|NCT03159676|"~     Stereotactic ablative body radiotherapy (SABR), or stereotactic body radiotherapy (SBRT), is~     a specialized form of radiotherapy used to treat prostate cancer with five treatments over~     two weeks, compared with a conventional eight-week or longer treatment course. The purpose of~     this trial is to investigate the effect that proton-based SABR has on quality-of-life in~     patients with localized prostate cancer. The evaluation and treatment will otherwise follow~     standard of care, and is not considered investigational.~   "
31124|NCT03159663|"~     Hemophilia is an X-linked congenital bleeding disorder caused by deficiency of coagulation~     factor VIII (in hemophilia A) or factor IX (in hemophilia B).~      The deficiency is the result of mutations of the respective clotting factor genes.~   "
31125|NCT03159650|"~     Chronic total occlusion is defined as thrombolysis in myocardial infarction (TIMI) flow grade~     0 with an estimated duration of at least 3 months. The interest in chronic total occlusion~     (CTO) percutaneous coronary intervention (PCI) has increased, but with failure rate up to~     20%, leading to important developments in dedicated equipment and techniques.~      In the 2014 European Guidelines on Myocardial Revascularization, intravascular ultrasound was~     recommended to guide stent implantation in selected patients, and this recommendation was a~     class IIa/level of evidence B.~      In CTO PCI, certain angiographic features such as blunt proximal CTO cap, tortuosity, heavy~     calcification, and lack of visibility of path in the distal vessel increase procedural~     difficulty~   "
31126|NCT03159637|"~     Laparoscopic surgery is now widely established.Laparoscopic surgery involves insufflation of~     a gas (usually carbon dioxide) into the peritoneal cavity producing a pneumoperitoneum. The~     raised intra-abdominal pressure of the pneumoperitoneum, alteration in the patient's position~     and effects of carbon dioxide absorption cause changes in physiology, especially within the~     cardiovascular and respiratory systems.~   "
31127|NCT03159624|"~     The purpose of this study is to demonstrate the utility of porcine small intestinal submucosa~     (SIS) as a graft material that may aid in the natural healing process of freshly exposed bone~     and cartilage in the nasal cavity.~   "
31128|NCT03159611|"~     Purpose of the study:~        -  To assess clinical efficacy of Tenoten for children liquid dosage form (oral drops at a~          daily dose of 10 drops, for 12 weeks) in the treatment of sequelae of perinatal injury~          to central nervous system (CNS) (cerebral hypoxic-ischaemic event and/or grade I or II~          intracranial haemorrhage).~        -  To assess safety of Tenoten for children liquid dosage form (oral drops at a daily dose~          of 10 drops, for 12 weeks) in the treatment of sequelae of perinatal injury to CNS~          (cerebral hypoxic-ischaemic event and/or grade I or II intracranial haemorrhage).~   "
31129|NCT03159598|"~     Drains are routinely utilized in breast reconstruction when using abdominal tissue of the~     patient to remove fluid buildup while the body heals after surgery. However, drains are~     associated with patient discomfort, anxiety, decreased mobility, increased hospital stays and~     outpatient visits. Drains can also serve as a site of origin for infection as the system is~     not completely closed, and infectious organisms could theoretically use the drain as point of~     entry.~      This proposed study investigates a potential novel mechanism to prevent the development of~     seromas (pockets of clear fluid which can develop after surgery) in patients who undergo~     breast reconstruction with their own abdominal tissue. By eliminating the required use of a~     drain, the study team expects patients to have less pain and use less pain medication, as~     well as more satisfaction with their overall surgical experience.~   "
31130|NCT03159585|"~     The main purpose of this trial is to investigate the safety and tolerability of~     TAEST16001（TCR Affinity Enhancing Specific T cell Therapy）in the multi-line treatment failed~     advanced solid tumors including bone and soft tissue sarcoma, melanoma, liver cancer,~     esophageal cancer, breast cancer, bladder cancer, prostate cancer, thyroid and ovarian~     cancer. The patients must meet the two criteria: human leukocyte antigens (HLA)-A*0201+ and~     NY-ESO-1 positive cells≥25% by immunohistochemisty.~   "
31131|NCT03159572|"~     To investigate the frequency and clinical significance of Homologous Recombination Deficiency~     (HRD) in Japanese patients with ovarian cancer (including Fallopian tube cancer and primary~     peritoneal cancer).~   "
31132|NCT03159559|"~     This study is undertaken to determine if intravenous Lipo-PGE1 therapy would improve coronary~     microvascular perfusion in patients with ischemic heart disease by CMRI.~   "
31133|NCT03159546|"~     This is a non-randomized, single arm, multi-center, prospective, non-significant risk study~     to evaluate the FreeStyle Libre Flash Glucose Monitoring System.~   "
31134|NCT03159533|"~     The proposed study Project IMPACT: CHW Intervention is part of a larger study examining the~     efficacy, adoption, and impact of integrated EHR-based decision-support and physician~     feedback interventions with community health worker (CHW)-led self-management and coaching~     support for South Asian patients with uncontrolled hypertension. This is a randomized control~     intervention utilizing community health worker (CHW)-led self-management and coaching support~     for South Asian patients with uncontrolled hypertension at PCP clinics in New York City.~   "
31135|NCT03159520|"~     To compare the analgesic property of acupressure with NSAIDs (Ibuprofen) in controlling pain~     following orthodontic treatment. This will be achieved by assessing the effectiveness of~     acupressure in controlling pain and discomfort by measuring the degree of pain relief after~     bonding of brackets to teeth and placement of initial archwire.~   "
31136|NCT03159507|"~     Determine whether personal optimization of the Omega-3 index improves cellular metabolism and~     quality of life (according to the SF-36 form).~   "
31137|NCT03159494|"~     10 patients with type 2 diabetes participated in a training-intervention consisting of 8~     times of High-Intensity Training (HIT). Before and after the intervention the patients were~     tested regarding Oral Glucose Tolerance Test, blood pressure, weight and fat% and VO2max. A~     pilot study was conducted with 6 patients with type 2 diabetes using the same protocol but~     only 6 times of training.~   "
31149|NCT03159338|"~     Patients who have mandibular deformity and will undergo bilateral sagittal split osteotomy~     will be included in the study.One side of the osteotomies randomly will be considered as~     study group and another side as a control group.In the study group , platelet rich fibrin~     will be placed after osteotomy and before rigid fixation.In the control group, fixation will~     be done without Platelet-rich Fibrin (PRF).Neurosensory disturbance will be evaluated 6 and~     12 months after surgeries.~   "
31138|NCT03159481|"~     African Americans (AA) are at higher risk to develop and go blind from glaucoma than~     Caucasians. While glaucoma medications can help delay disease progression and possible~     blindness, problems with poor adherence have been documented for both racial groups, with a~     greater prevalence among AA. Of the very few interventions targeting glaucoma medication~     adherence studied to date, several methodological limitations persist. For example, few have~     been subjected to rigorous randomized clinical trial (RCT) designs, the intervention itself~     was designed and studied predominantly among Caucasians and thereby limiting~     generalizability, the effects on adherence have been short-term, most have been evaluated on~     small sample sizes, and/or the focus of the intervention was solely on providing patient~     education regarding eye disease and management. Needed in this important yet understudied~     area are culturally-relevant, health promotion-based approaches which are 1) targeted to high~     risk populations, 2) theoretically driven, 3) relevant to the beliefs, language, and values~     of underserved populations as well as challenges related to glaucoma medication adherence, 4)~     designed to promote preparation and readiness to engage in healthy behaviors, and 5) train~     patients in skills to use in order to more effectively problem-solve ongoing obstacles~     related to adherence.~      The investigators published a paper in the Journal of Glaucoma investigating determinants~     related to objective medication adherence as measured by an electronic dosing aid (DA).~     Findings revealed poorer rates of adherence among AA patients with glaucoma compared to~     Caucasian patients with glaucoma. Evidence for racial differences in adherence have also been~     increasingly documented in the glaucoma literature. In a follow-up study with focus groups of~     AA's with glaucoma that was published in Optometry and Vision Sciences, the goal was to~     identify the specific barriers and facilitators related to glaucoma medication adherence~     among this high-risk group. Several key themes emerged such as patient, provider, and~     socioeconomic factors, along with barriers in views of health, perceived harm from treatment,~     costs, avoidant coping styles, forgetfulness, and in eyedrop administration/scheduling. The~     investigators used these results along with guidance from a consumer advisory board~     consisting of AA patients with glaucoma in order to develop and pilot test the resulting~     culturally relevant, health promotion-based intervention. The pilot data demonstrated~     feasibility and favorable preliminary efficacy for the intervention to significantly improve~     medication adherence to further pursue in a clinical trial.~   "
31139|NCT03159468|"~     Rates of sexual assault are alarmingly high, and alcohol is consistently implicated in the~     majority of these assaults. Despite well-intentioned prevention efforts, this pandemic~     continues unabated, warranting the development of novel and innovative approaches to the~     reduction of sexual aggression. The goal of this research is to evaluate the efficacy of two~     brief online emotion regulation interventions for reducing alcohol-related sexual aggression~     in heavy episodic drinking young men with a sexual aggression history. Previous research~     suggests that emotion regulation difficulties are associated with both alcohol consumption~     and aggressive behavior. Despite the potential prevention utility of improving sexually~     aggressive men's emotion regulation skills in order to reduce their alcohol-related sexual~     aggression, this approach has yet to be explored. Thus, this study evaluates the effects of~     two brief online ER interventions - cognitive restructuring and mindfulness - on men's~     emotion regulation during a sexual aggression-related analogue. Additionally, these effects~     will be evaluated during both sober and intoxicated states through a laboratory- based~     alcohol administration experiment.~   "
31140|NCT03159455|"~     The primary objective of the current study is to investigate the safety and tolerability of~     BI 1467335 in healthy Japanese male subjects following oral administration of multiple rising~     doses The Caucasian group will receive higher dose only.~      A secondary objective is the exploration of the pharmacokinetics and pharmacodynamics of BI~     1467335 in healthy Japanese and Caucasian male subjects.~   "
31141|NCT03159442|"~     AZD8871 is a new chemical entity possessing long-acting dual-pharmacology (muscarinic~     receptor antagonist and β2 adrenoceptor agonist [MABA]) in a single molecule. This type of~     agent presents a novel approach to the treatment of chronic obstructive pulmonary disease~     (COPD) and potentially asthma (in combination with an inhaled corticosteroid). AZD8871 is~     being developed for inhalation, formulated with alpha lactose monohydrate and delivered by~     dry powder inhaler (DPI) that allows delivery of a single dose of the study drug.~      The primary objective is to investigate the safety and tolerability of AZD8871 at steady~     state in healthy male Japanese subjects.~   "
31142|NCT03159429|"~     The main objective of this study is to measure the effect (at 3 months) of dyspnea control~     rehabilitation with nasal ventilation versus standard rehabilitation, in dyspneic patients~     with hyperventilation syndrome.~   "
31143|NCT03159416|"~     This study is a Phase I, single-dose, open-label trial to evaluate the safety, tolerability,~     pharmacokinetics (PK), and pharmacodynamics of a single dose of inclisiran subcutaneous (SC)~     injection in participants with mild, moderate, and severe renal impairment compared to~     participants with normal renal function.~   "
31144|NCT03159403|"~     This study is a retrospective, observational study to evaluate oritavancin use in~     participants under real world conditions.~   "
31145|NCT03159390|"~     Intravenous infusion of stable tracers of ornithine, glutamine, glutamate, and glycine will~     be performed, and collect blood samples, urine samples, and muscle biopsies to evaluate the~     effect of a continuous oral intake of phenylacetate salt of ornithine (OP) on its metabolic~     fate.~   "
31146|NCT03159377|"~     We will perform an ultra low-dose CT (ULDCT) in addition to a regular chest CT scan for adult~     patients undergoing a clinically indicated chest CT. Using a recently developed~     computationally efficient algorithm for the denoising of ULDCT scans after image~     reconstruction, we will compare the sensitivity, specificity and accuracy of lesion detection~     with the ULDCT as compared to the regular CT scan.~   "
31147|NCT03159364|"~     Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) result in significant morbidity and~     mortality in hematopoietic stem cell transplantation (HSCT) patients in China. Antiviral~     drugs are usually used for prophylactic purposes and treatment after early detectable viral~     load. Unfortunately, some patients may develop resistance to antivirals. In addition to~     patient with HSCT, immune compromised patients may also been the targets for these~     opportunistic viruses. Thus in this study, the safety and efficacy of CMV and EBV specific~     cytotoxic T cells (CTLs) will be determined.~   "
31148|NCT03159351|"~     This is a multicenter, randomized, double-blind, placebo-controlled trial aims to assess the~     effectiveness of repetitive transcranial magnetic stimulation(rTMS) in treating depression~     after basal ganglia ischemic stroke and to examine whether such effects are related to~     restoration of white matter integrity.Sixty-six participants will be recruited from three~     centers and randomized with a 1:1 ratio to receive active rTMS treatment or sham rTMS~     treatment in addition to routine supportive treatments.The data of neuropsychological tests~     and MRI will be collected at 0, 2 and 4 weeks after the commencement of the treatment.~   "
31181|NCT03158922|"~     BARCODE 1 is a screening study designed to investigate the role of genetic profiling for~     targeting population prostate cancer screening. This study forms a pilot of 300 men, with the~     view to continue to a future study of 5000 men.~   "
31150|NCT03159325|"~     Heart disease is a leading cause of death and disability in Canada. Providing social and peer~     supports has been proven to help patients manage their health and stay out of the hospital.~     The use of telehealth has opened up a wider possibility of patients receiving peer support~     while staying in their homes and communities. The investigators plan to study a new~     application for supporting patients through peer support. The application can be accessed by~     smartphone, tablet and desktop/laptop computer. Over two years, the investigators anticipate~     that the application (Healing Circles) will improve patient self care and reduce~     hospitalizations.~   "
31151|NCT03159312|"~     Obesity is a multifactorial disorder resulting from multivariate etiopathogenic factors. The~     current lifestyle, causes a gradual increase in weight both in the adult population and in~     the child population. Among their treatments is bariatric surgery. About which there is~     little evidence in the literature regarding the health condition developed by patients~     operated on the same. Objective: To know the influence of a moderate exercise program on~     health status in patients operated on with bariatric surgery. Methodology: A controlled~     clinical trial, the population will consist of 52 women and 18 men. Coming from the~     consultations of bariatric surgery of the Clinic of the Maule - Talca. In the period between~     March 2017 and March 2018. It will be selected following a non-probabilistic sampling and for~     convenience. Results Analysis: The variables used in this study will be: cardiovascular~     function, respiratory function, strength, health perception, anthropometric measures and~     functional capacity to perform exercises. The Shapiro-Wilk normality test will be performed~     to determine the distribution of the data to be analyzed. The t-student test or its~     nonparametric counterpart will be applied to compare two variables. To compare three or more~     variables, the ANOVA or Kruskal-Wallis test will be used depending on the results of the~     normality test.~   "
31152|NCT03159299|"~     The aims of this study are:~        1. To translate an evidence-based diabetes self-management education (DSME) program, Yo~          Puedo!, to the cultural norms, expertise of providers, and systems of care in Seguro~          Popular clinics in Mexico. The program will be adapted through a collaborative team of~          diabetes experts in the US and Mexico, Seguro Popular clinic administrators, physicians,~          nurses and adults with type 2 diabetes (T2D) in Mexico City, Mexico. This will include~          development and testing of a theory-based mHealth (pictorial text-messaging) component.~        2. To evaluate the feasibility (process of implementation, fidelity of sessions,~          attendance, attrition), acceptability (interviews with nurse, CHW, participants) and~          preliminary efficacy of Yo Puedo!+mHealth in adults with T2D in Mexico City. A~          randomized, controlled pilot study design will be used in which 40 adults with T2D are~          randomized to the Yo Puedo! + mHealth or a wait-list control condition with the~          hypothesis that clinical [A1C, body mass index (BMI), blood pressure (BP)], T2D~          self-management, and self-efficacy outcomes will be greater in You Puedo!+mHealth~          participants compared to the wait-list control condition at 3 and 6 month follow-up. A~          secondary hypothesis that the Yo Puedo! + mHealth program is feasible and acceptable to~          adults with T2D and providers and that fidelity of the program will be maintained.~   "
31153|NCT03159286|"~     The proposed research will be the first study to focus on experimentally manipulating both~     injunctive and descriptive norms on social networking sites in order to elucidate the~     relationship between alcohol and abstainer displays on social networking sites and subsequent~     alcohol cognitions, use, and related negative consequences. Based on literature focusing on~     developmentally appropriate health models for adolescents, the Prototype Willingness Model~     (PWM) assumes that health-risk behaviors occur either when individuals have developed~     intentions to engage in a risk behavior (and these intentions vary as a function of attitudes~     and perceived injunctive norms) or through willingness to engage in risks (which varies as a~     function of perceived vulnerability to negative consequences, perceived descriptive norms ,~     and prototypes). To fully understand the relationships between alcohol abstaining displays on~     social networking sites, we will examine 1) the role of descriptive and injunctive abstainer~     and user norms, when experimentally manipulated with SNS profiles, on willingness and~     intentions, subsequent alcohol use and related negative consequences among adolescents (age 1~     5-20) 2) whether intentions and willingness mediate the relation between our experimental~     manipulation and subsequent alcohol use and negative consequences and whether 3) individual~     differences in social influence moderate the effect of the experimental manipulation on~     intentions, willingness, alcohol use, and negative consequences. We will test these aims by~     recruiting a community sample of adolescents (N = 300), living in the greater Seattle~     metropolitan area. Participants will complete a web-based baseline assessment and participate~     in an in-person experimental manipulation in which they are either assigned to see same-sex~     social networking site profiles of alcohol abstainers, abstainers +users, or a control~     condition where neither user or abstainer information will be provided. Immediately after the~     manipulation, participants will answer a series of questions about the profiles they just~     viewed and their alcohol-related cognitions. Participants will also complete a one-month in~     person follow up assessment to test for impacts on intentions, willingness, alcohol use, and~     related negative consequences. Additionally, individual differences in social influence will~     be examined as possible moderators o f the relationship between SNS-portrayed norms and our~     primary outcomes. This study is both significant and innovative in that it uses a theoretical~     perspective to experimentally test the impact of alcohol content, in particular abstainer~     norms, on Facebook on adolescent alcohol use and related cognitions. The results have the~     potential to inform preventative interventions while addressing NIH priorities.~   "
31154|NCT03159273|"~     The purpose of the present study is to explore the effects of a dietary nitrate supplement on~     immunity, mood, cardiovascular activity, and lung function during and following final exam~     stress in both healthy and asthmatic individuals.~   "
31155|NCT03159260|"~     The purpose of this study is to determine the effect of Theraworx/[pH]uel on the frequency~     and severity of night-time cramps and spasms symptoms, including quality of life, depression~     and sleep quality when compared to a placebo.~   "
31156|NCT03159247|"~     The purpose of this research study is to test the impact of two personalized technology based~     programs that may help improve adherence to glaucoma medications.~   "
31157|NCT03159234|"~     Diabetes is the most common medical complication of pregnancy in the united states four to~     five percent of pregnancies are complicated by diabetes.~      Pregestational diabetes (diabetes diagnosed before pregnancy, type 1 or type 2 diabetes~     mellitus) comprises approximately 13 percent of all diabetes in pregnancy, while gestational~     diabetes ( diabetes with onset or first recognition in pregnancy) comprises the remaining 87~     percent . The prevalence of pregestational diabetes has been increasing due to the increasing~     prevalence of type 2 diabetes in women of reproductive age . The mainstay of the medical~     management of pregestational diabetes involves frequent monitoring of blood glucose levels~     with adjustment of diet and insulin therapy to achieve normoglycemia. Normoglycemia is~     important because maintenance of maternal blood glucose concentration at or near~     normoglycemic levels decreases the likelihood of adverse pregnancy outcomes, such as~     miscarriage , congenital anomalies , macrosomia and fetal death.~   "
31158|NCT03159221|"~     This is a randomized, controlled pilot trial of Behavioral Family Systems Therapy for Teens~     with Type 2 Diabetes (BFST-DM2), an individual psychological intervention tailored to meet~     the needs of teens with type 2 diabetes. It is hypothesized that this behavioral family~     intervention will be feasible to implement with teens with type 2 diabetes and will have~     positive effects on treatment adherence, health outcomes like weight status and metabolic~     control, and psychological outcomes.~   "
31159|NCT03159208|"~     The purpose of the study is to establish clinical determinants of poor cognitive and physical~     functional outcome of CCI patients so that the investigators may develop and validate a~     multi-dimensional clinical prediction model to more effectively inform decision making~     earlier in the course of the ICU care. The investigators hypothesize that multiple premorbid~     and acute factors measured early in the course of CCI will have strong independent~     associations with functional recovery. The investigators further hypothesize that social and~     economic factors are associated with long-term functional outcomes independent of the acute~     clinical problems.~   "
31160|NCT03159195|"~     To describe patient demographics, clinical characteristics, treatment patterns and clinical~     outcomes of adult female patients who have received palbociclib combination treatments in~     line with regional licensed indications in real world settings across multiple countries.~   "
31161|NCT03159182|"~     The purpose of this study is to determine if the use of silicone material inserts within~     pressure garments is effective in decreasing hypertrophic burn scar formation as compared to~     standard pressure garment therapy.~   "
31162|NCT03159169|"~     This is a prospective, open label, multicenter feasibility study to evaluate the safety and~     therapeutic efficacy of BurstDRTM SCS in treating chronic neck pain with or without radiation~     down to arm/shoulder/upper back~   "
31163|NCT03159156|"~     For a number of years, researchers have examined the effects of the muscle-tensing technique,~     Applied Tension (AT), on blood donation-related vasovagal symptoms and donor retention. AT~     was developed originally to reduce symptoms and avoidance behaviour in people with strong~     fears of blood and needles (phobics). It was based on the idea that exercise-related~     increases in blood pressure might be able to counteract the effects of stimuli that lead to a~     decrease in delivery of blood to the brain. AT was adapted for non-phobic blood donors and~     significant reductions in self-reported vasovagal symptoms and the need for nurse-initiated~     treatment as well as increases in donor retention were observed in some groups.~      That said, individual response to AT is quite variable. This is probably related to recent~     research indicating that exercise-related maintenance of heart rate and blood pressure plays~     only a minor role in reducing vasovagal symptoms. Rather, AT appears to be working at least~     in part by regulating breathing and reducing the possibility of hyperventilation. Pilot~     results suggest that a novel intervention aimed specifically at breathing may be more~     effective and reliable than traditional AT. To evaluate this idea, 408 blood donors at mobile~     clinics in colleges and universities will be assigned randomly to four conditions. In brief,~     5-minute preparation sessions using a notebook computer, donors will either learn a~     respiration control technique to avoid hyperventilation, AT, both, or neither. As a~     manipulation check and also a means of examining mechanisms of the interventions, e.g., the~     possibility that AT may work by regulating breathing and CO2, participants will wear~     non-invasive portable capnometers while they are giving blood. Outcome will also be assessed~     by self-report of vasovagal symptoms, observational data, and number of return visits to a~     blood clinic in the following year verified by the provincial blood collection agency,~     Héma-Québec. As a secondary aim, the research will examine possible moderating effects of~     pre-donation anxiety and sex.~      The development of simple, effective approaches to reduce vasovagal symptoms during blood~     donation has the potential to improve the blood donation experience and blood donor retention~     as well as encourage people who have never given blood to consider the procedure. It will~     also improve medical and dental care more generally given the use of needles in so many~     procedures.~   "
31164|NCT03159143|"~     The purpose of this non-randomized Phase II trial was to evaluate the efficacy of a~     combination of docetaxel and oxaliplatin in patients with metastatic transitional cell cancer~     (TCC) of the urothelial tract. The primary endpoint was to assess response, as defined as a~     25% reduction in measurable disease per the RECIST criteria. Measurable or evaluable~     objective response rate, time to disease progression and survival were also assessed.~   "
31165|NCT03159130|"~     This study will assess the efficacy of OnQ pain catheters in pain reduction in the bariatric~     surgical population and seeks to identify if a quantifiable improved post-operative course~     occurs in patients receiving a catheter filled with local anesthetic versus that achieved by~     patients who receive a catheter filled with injectable saline.~   "
31166|NCT03159117|"~     The purpose of this research study is to learn about the safety and effectiveness of the~     study drug, PF-06688992. Before this study, PF-06688992 has never been given to people.~      PF-06688992 is a targeted therapy for people with cancer. The investigators linked a~     chemotherapy drug to an antibody (protein found in the blood). The antibody will connect to~     GD3 which is found on most melanomas but on very few other cells in the body. The~     investigators hope that in this way, it will deliver this chemotherapy directly to the~     melanoma and not to normal tissues.~   "
31167|NCT03159104|"~     Purpose of the study:~        -  To assess efficacy of Tenoten for children® in children with specific developmental~          disorders of scholastic skills.~        -  To assess safety of Tenoten for children® in children with specific developmental~          disorders of scholastic skills.~   "
31168|NCT03159091|"~     The purpose of this study is to obtain additional data on efficacy and safety of Rengalin in~     the treatment of cough in patients with stable obstructive pulmonary disease~   "
31169|NCT03159078|"~     The purpose of this study is to assess the safety and efficacy of polymyxin B as monotherapy~     versus a combined polymyxin B-carbapenem therapy against multidrug-resistant (MDR) gram~     negative infections. The investigators intend to evaluate if this synergistic drug regimen~     correlates with improved outcomes against gram-negative infections in critically ill patients~     including: better clinical resolution, reduced length of stay at hospital, reduced length of~     stay at the intensive care unit, and less recurrence of infection.~   "
31170|NCT03159065|"~     Consumption of polyphenol-rich fruits and vegetables may improve the postprandial glucose and~     insulin responses and hence promote well-being. It has previously been observed that~     consumption of a bilberry drink decreases the postprandial insulin demand. In the present~     study, the impact of probiotic fruit beverages with different polyphenol profiles on the~     postprandial levels of glucose and insulin, were investigated.~   "
31171|NCT03159052|"~     The purpose of this study is to obtain information on efficacy and safety of SHR3824 over 24~     weeks and 52 weeks in Chinese patients with Type 2 Diabetes. This will be done by comparing~     the effect of SHR3824 to placebo when given in oral doses.~   "
31182|NCT03158909|"~     This study evaluates the effect of earplugs and eyemask for delirium prevention among elderly~     in-patients. Half of patients will receive earplugs and eyemask for use during the night and~     information about orientation to time and space every night, while the other half will~     receive only the time and space orientations.~   "
31183|NCT03158896|"~     This study evaluates the safety and effectiveness of two different doses of umbilical cord~     derived, ex-vivo cultured and expanded Wharton's jelly mesenchymal stem cells (MSCTC-0010) in~     the treatment of acute Graft versus Host Disease (aGVHD). The first 5 participants enrolled~     in the study will receive a lower dose of MSCTC-0010. If none of the first 5 participants~     have treatment-related serious adverse events (TRSAEs) for 42 days, then the next 5~     participants will receive a slightly higher dose of MSCTC-0010.~   "
31172|NCT03159039|"~     Respiratory diseases are a major morbidity and mortality causes of neonatal requiring~     mechanical ventilation, especially in newborn preterm infants (PN), thus respiratory therapy~     becomes increasingly necessary in order to minimize the effects of complications and improve~     respiratory functions, increasing mucociliary transport with techniques that consist of~     manual maneuvers to bronchial hygiene, such as vibro associated with postural drainage and~     prolonged slow exhalation. Objective: To compare and analyze the effects of convensional~     physiotherapy (CP) versus prolonged slow exhalation (PSE) in heart rate (HR), and respiratory~     rate (RR), O2 saturation (SpO2) and Tidal Volume (TV), time permanence of mechanical~     ventilation (TMV) and number of extubation failure (EF) in premature infants on mechanical~     ventilation (MV). Methods: Randomized clinical trial conducted in the neonatal intensive care~     unit of the General Hospital Itapecerica da Serra Seconci OSS SP, comparing two physical~     therapy techniques applied to preterm infants on mechanical ventilation.~   "
31173|NCT03159026|"~     The natural history of patients with PA-AMV has not been systematically studied before and~     there is no published data in the literature about this condition since 1980. There is no~     evidence-based approach to care of these patients, particularly the younger patients who may~     no come to medical attention until significant cardiac problems develop. Through systematic~     review of existing medical records on essentially all known patient with this condition,~     investigators plan to develop an evidence-based management plan for preventive care of these~     patients.~   "
31174|NCT03159013|"~     Exposure to pyrethroid pesticides is a growing concern in the workplace especially since they~     are also present in the diet of the general population. It is important to monitor human~     exposure to these contaminants. Exposure to pyrethroids may occur by multiple routes of~     exposure (oral, inhalation and dermal), such that it is difficult to assess absorbed doses~     from external exposure assessments. Biological monitoring, which consists of measuring~     urinary metabolites, is now recognized by the scientific community as a preferred approach to~     assess exposure to this type of compound. These metabolites are biotransformation products~     produced in the human body from the exposure compounds. However, interpretation of these~     biological monitoring data requires a proper knowledge of the kinetic behavior and thus the~     fate of the substance of interest in the human body in order to link levels of biomarkers in~     individuals to actual absorbed doses. Human kinetic data are still poorly documented in the~     case of pyrethroids. The study in volunteers exposed to pyrethroids in controlled conditions~     will allow acquiring new urinary and blood profiles to refine and address uncertainties in~     the toxicokinetics of lambda-cyhalothrin following oral and dermal exposure. Those data will~     serve to build a toxicokinetic model to predict absorbed doses in workers from urinary~     metabolite measurements and therefore better assess health risks.~   "
31175|NCT03159000|"~     Several observational studies have shown improvement in episodic migraine with the use of~     greater occipital nerve block as an acute therapy, and a recent placebo controlled trial did~     not show a decrease in frequency of episodic or chronic migraine; however, there has never~     been a placebo controlled trial to investigate the efficacy of GONB as an acute treatment for~     headache, and there has been no determination of guidelines for selection of patients who~     would be most likely to respond to GONB. In light of the above, the investigators propose a~     double-blind, placebo-controlled, randomized trial examining the use of GONB with~     lidocaine/bupivocaine in patients with an acute episodic migraine. The results of this trial~     are expected to guide more appropriate therapeutic management of these participants and the~     optimal use of this procedure. 50 subjects will be entered into this study. This study is~     being conducted at Thomas Jefferson University only.~   "
31176|NCT03158987|"~     This retrospective observational study aims at the examination of regional differences in the~     procedure of referral for serological HIV testing between eastern (new) and western (old)~     German federal states.~   "
31177|NCT03158974|"~     This trial will be a phase 2, open-label, study to evaluate the safety, tolerability, and~     efficacy of VIR007 when administered topically for up to 60 days to adults between the ages~     of 18 to 65 years with a clinical diagnosis of external condylomata acuminata.~   "
31178|NCT03158961|"~     Thyroid surgery has been developed as a new technique for zero scar in surgery by applying~     transoral endoscopic thyroidectomy with sublingual approach. The new technique is locating~     the surgery which pierced through floor of mouth, cause severe tissue damage, high~     complication, and conversion rates to open surgery and surgical difficulties due to~     limitation of movement. Nevertheless, each report is still including small number of~     patients. Recently, the transoral endoscopic thyroidectomy vestibular approach (TOETVA) has~     been proven feasible and safe in several overseas centers. Moreover, a successful TOETVA case~     was reported in local media in the late last year. Hence, this study is for evaluating the~     feasibility and safety of the TOETVA prospectively at a tertiary referral center in Hong~     Kong.~      The following are the procedure of the study:~        1. Recruit patients from the clinic.~        2. Patients will receive treatment within 3 months~        3. Patients will have different assessments like Ultrasonography assessment, Fine needle~          biopsy, Direct laryngoscopy, and Cosmectic scoring in Pre-operation, post-operation 2~          week, post 1 month, post 3 month, post 6 month and post 12 month.~        4. Patients will be monitoring by the same team after the study.~   "
31179|NCT03158948|"~     This is a randomised, double-blind, two-stage, placebo controlled study. It is designed to~     investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of 3 doses of~     MOTREM versus placebo in adult patients with septic shock.~   "
31180|NCT03158935|"~     This is a phase 1b study for patients with metastatic (cancer has spread to various parts of~     the body) melanoma and ovarian cancer. The main purpose is to examine the safety and efficacy~     of administering pembrolizumab after receiving chemotherapy, tumor-infiltrating lymphocytes~     (TIL) and low dose interleukin 2 (IL-2).~      Patients will first receive either cyclophosphamide, or cyclophosphamide and fludarabine.~     These are chemotherapy agents that prepare the body to receive TILs.~      Patients are then infused with autologous TILs, a type of white blood cell that recognizes~     tumor cells and enters them, thereby causing tumor cells to break down.~      Following TILs infusion, patients will receive low-dose IL-2 therapy. This is a type of~     protein that is intended to activate and stimulate the growth of cells in the patient's~     immune system.~      If the patient meets the required criteria, they will be given pembrolizumab, a monoclonal~     antibody (drug made up of cloned immune cells) that is designed to block a protein called~     programed cell death ligand 1 (PD-L1) which will allow the body's immune system to kill the~     cancer cells.~   "
31186|NCT03158857|"~     Hepatitis C is an important health problem in Myanmar affecting around 3% of the population.~     New drugs have been developed which have transformed the treatment of this disease around the~     world with very high success rates. Two of these drugs are now registered for use in Myanmar.~     In this study 200 patients with chronic hepatitis C(100 with HIV co-infection) will be~     assessed and started on the new treatment. We will observe them and measure treatment~     effectiveness and tolerability. In 24 patients extra blood samples will be taken for drug~     measurements to describe the effect of the drugs on patients in Myanmar in more detail.~   "
31187|NCT03158844|"~     The population of inpatients is large in Zambia; however, because of poor linkages between~     hospitals and community HIV care, there are few data to analyze their engagement in HIV care~     before and after hospitalization. The goal of the study is to learn more about Zambian adults~     who are HIV-infected and get hospitalized. The purpose of this study is to gather formative,~     preliminary data, to be used in future grant applications to improve linkage and engagement~     in HIV care in Zambia.~   "
31188|NCT03158831|"~     The investigators are conducting a prospective study to determine the safety and outcomes of~     placebo-controlled graded drug challenges without prior skin testing in patients with a~     low-risk history of antibiotic hypersensitivity reaction based on history alone. The~     investigators hypothesize that the rate of reaction to graded drug challenges without prior~     skin testing in patients with a low-risk history of drug hypersensitivity reaction based on~     history alone will not be meaningfully more than the rate of reaction to placebo. The~     investigators hypothesize that the rate of adverse reactions to drug challenges without prior~     skin testing will not be meaningfully more than the rate of adverse reactions with prior skin~     testing as was observed in the investigators' historical clinic cohort.~   "
31189|NCT03158818|"~     Chronic hepatitis B virus infection is a common condition in Zambia. Among Zambian blood~     donors, up to 8% are chronically infected with HBV. Despite the burden, awareness of HBV is~     low in Zambia and the Ministry of Health is in early stages of development of guidelines for~     HBV screening, treatment, and prevention. The purpose of this clinical cohort study is to~     characterize the clinical features of chronic HBV infection at UTH and describe treatment and~     care outcomes. The investigators will enroll 500 adults and follow the cohort for up to 5~     years to assess short and long-term viral, serologic, and liver outcomes such as cirrhosis~     and liver cancer.~   "
31190|NCT03158805|"~     Taken together these data support the hypothesis that liraglutide 3.0 mg sc injection will~     reduce body weight and improve metabolic variables in obese or overweight patients with BP~     without worsening psychiatric symptoms. The investigators predict that liraglutide 3.0 mg sc~     injection will display greater efficacy as compared to placebo in decreasing body weight in~     patients with BP who are obese or overweight. To prove this hypothesis, investigators will~     conduct a single-center, randomized, placebo-controlled, double-blind, parallel-group, 2-arm~     clinical trial of liraglutide 3.0 mg sc injection in 60 obese or overweight outpatients with~     stable BP. The investigators have chosen BP rather than another SMI because it is the most~     common SMI (more common than schizophrenia or schizoaffective disorder) and has a~     particularly strong association with obesity.~   "
31191|NCT03158792|"~     This is a clinical trial including non-surgical patients, 70 years of age or older, with~     renal impairment requiring pharmacological venous thromboembolism prevention during~     hospitalization. Patients are randomized to receive either 20 mg or 30mg of enoxaparin. Both~     dosing regimens of enoxaparin have been approved for thromboprophylaxis in impaired kidney~     function in different countries. Therefore, this study aims to evaluate the efficacy and~     safety of enoxaparin 20mg versus 30mg subcutaneously daily by comparing anti-xa levels,~     thrombosis and bleeding events.~   "
31192|NCT03158779|"~     The aim of this phase II study is to assess the efficacy and safety of sequentially~     integrated treatment of FOLFIRINOX or Gemcitabine-Abraxane and SBRT in patients with~     unresectable pancreatic cancer.~   "
31193|NCT03158766|"~     Subclinical infection of the intervertebral disc after lumbar disc herniation surgery has~     been correlated to chronic low back pain and vertebral endplate changes. The most commonly~     reported agent is Propionibacterium acnes. However, the real incidence is unclear, as it has~     been reported in some series ranging from 3.7% to 46%. Recently, a systematic review~     concluded that there is a relationship between P. acnes and endplate changes, but, there are~     so far no studies to verify whether the reported presence of that pathogen in the~     intervertebral discs is due to local infection or whether intraoperative contamination~     occurred during the collection of samples.~      Thus, the main objective of this study is to estimate the incidence of subclinical infection~     in patients surgically treated for lumbar disc herniation.~      To this end, a prospective cohort study will be conducted with a minimum of 95 patients~     between 18 and 65 years of age who have been submitted to surgery after failure of~     conservative treatment. The extruded disc will be removed and cultured for bacterial~     identification. As controls, the ligamentum flavum and the multifidus muscle, taken~     respectively before and after removal of the herniated fragment will also be cultured.~     Patients will be followed-up for a year and MRI will be done at the end of this period.~   "
31194|NCT03158753|"~     Perfusion index (PI) measured via a pulse oximeter has been shown to correlate with~     activation of the sympathetic nervous system, such as by pain stimulation, as a result of~     involuntary contraction of the arterioles. Thus PI holds potential for use as a tool for~     objective pain measurement, although its practical usefulness and dependability as such~     have not previously been investigated.~      The investigators aim to explore associations between changes in PI and onset of pain~     following cessation of regional anaesthesia in alert patients following ankle fracture~     surgery.~      Methods:~      The investigators report an exploratory, observational analysis of prospectively gathered PI~     data from patients undergoing regional anaesthesia with spinal or peripheral nerve block for~     ankle fracture surgery as participants of the randomised AnAnkle Trial (EudraCT:~     2015-001108-76). PI is measured on an unaffected extremity in approximately 20 consecutive~     patients already included in the AnAnkle Trial at Herlev University Hospital, evenly~     distributed between spinal anaesthesia (SA) and peripheral nerve block (PNB).~      Both anaesthesia forms and pain medication regimes are standardised as part of AnAnkle Trial~     and participants register pain scores on a 0-10 numeric rating scale every three hours and~     register the time of cessation of anaesthesia identified by return of sensation to the ankle.~     Morphine consumption is also registered.~      The investigators will explore correlations of changes in PI to increases in pain upon~     cessation of the regional anaesthesia and, secondly, differences in cessation related PI~     changes with SA versus PNB.~      Ethics:~      All participants have already given informed, written consent for use of this data for the~     AnAnkle Trial. All necessary ethical and legislative approvals have been obtained for~     initiation of AnAnkle Trial in July 2015.~   "
31195|NCT03158740|"~     A large, persuasive, and ever-increasing body of evidence links chronic inflammation to~     virtually all of the chronic diseases that cause the majority of disability and death in the~     U.S., including diabetes, cardiovascular diseases (CVD), and cancer. Diet plays a central~     role in the regulation of chronic inflammation. However, until investigators developed the~     Dietary Inflammatory Index (DII)TM there had been no scientifically valid way to relate what~     individuals eat to the capacity of foods consumed to modulate inflammation. The DII has now~     produced an impressive research base that ranges from predicting blood levels of inflammatory~     biomarkers; to a variety of health-related endpoints including cancer incidence and~     mortality, diabetes, and CVD; to psychological endpoints including depression and cognitive~     functioning. Watermelon is a member of the Cucurbitaceae family of gourds and is related to~     the cucumber, squash, and pumpkin. Watermelon flesh (WM) is ~91% water by weight, and is a~     rich source of bioavailable compounds including lycopene and other carotenoids, and vitamins~     A and C, all of which have anti-inflammatory properties. Watermelon is already known to play~     an effective role in reducing risk of chronic inflammation related conditions like coronary~     heart disease. Connecting Health Innovations (CHI) through this proposal is committed to~     developing a watermelon supplemented dietary intervention to reduce inflammation. The DII~     provides a tool that will form the basis of a counseling/instructional system aimed at~     helping patients and their providers to control chronic, systemic inflammation by improving~     the diet with specific, actionable dietary recommendations, counseling, and expert~     instruction. Our first aim is to refine and modify the DII-based intervention by developing~     and incorporating several watermelon recipes which will score low (anti-inflammatory) on the~     DII scale. Our second aim is to design and implement a two-arm intervention trial based on~     watermelon-focused DII recommendations aimed at reducing levels of chronic inflammation in~     Columbia, South Carolina; the two arms of this intervention study will be the DII-Based~     Counseling System, including access to our Imagine Healthy Online Portal, and a general~     health education control. Data will include questionnaires (e.g., demographics, health~     history, stress, depression, self-efficacy for physical activity and diet, social approval,~     social desirability), anthropometrics measures, physical activity monitoring, inflammatory~     marker C-reactive protein (CRP), and ASA 24-hour dietary recalls. Baseline data collection~     will be followed by a 12-week intervention period. The DII arm will receive in-person healthy~     cooking and nutrition classes, along with physical activity and stress reduction activities.~     Additionally, this arm will receive access to the Imagine Healthy Online Portal. The general~     health control arm will receive weekly health education information. Linear mixed models~     (LMM) will be used to determine whether the intervention arms are associated with the primary~     outcome (i.e., CRP).~   "
44423|NCT02985333|"~     The purpose of this study is to evaluate the efficacy and safety of paclitaxel in combination~     with cyclophosphamide and dexamethasone in chinese patients with relapsed/refractory multiple~     myeloma.~   "
31196|NCT03158727|"~     The purpose of this randomised, multicentre, double-blind, placebo-controlled, phase Ib/IIa~     study is to assess the safety, tolerability and efficacy of eASCs (Cx611) administered~     intravenously as adjunctive therapy, therefore in addition to standard of care (SoC) therapy,~     to patients with severe community-acquired bacterial pneumonia (sCABP).~      The completion of this study will contribute to the basic knowledge on stem cells and their~     mode-of-action, and has a large translational character, i.e. to document the safety and~     explore the efficacy of Cx611 in patients with sCABP.~   "
31197|NCT03158714|"~     The Alabama Healthy Marriage and Relationship Education Initiative (AHMREI), a large-scale~     partnership among Auburn University and 9 additional implementation partners at Family~     Resource Centers, implements multiple program activities that respond to family needs and~     integrate comprehensive services to promote healthy marriages and relationships, as~     authorized by the Claims Resolution Act of 2010 (Pub. L. 111-291). The purpose of this study~     is to evaluate the efficacy of two selected couples education curricula- Elevate and Couples~     Connecting Mindfully. The programs are intended to improve the well-being of individuals,~     couples, and families in domains such as couple well-being, parenting skills, individual~     skills, and economic stability.~   "
31198|NCT03158701|"~     .Cardiac affection in liver cirrhosis is a clinical condition characterized by impaired~     diastolic relaxation and contractility with electrophysiological abnormalities.~      .Cirrhotic patients with cardiac abnormality have higher mortality rates compared to patients~     without cardiac affection.~      The suggested pathophysiologic mechanisms of cardiac affection in cirrhotic patients are;~     alterations in the beta-adrenergic signaling pathway and, myocardial fibrosis formation,~     sympathetic nervous system activation and changes in ion channels.~      .As a component of cardiac involvement in cirrhotic patients fragmented QRS complex and~     prolongation of the corrected QT interval has been documented in most of the cases with liver~     cirrhosis (LC) and its prevalence increases with the severity of the disease~   "
31199|NCT03158688|"~     Compare carfizomib, dexamethasone, and daratumumab (KdD) to Carfilzomib and dexamethasone~     (Kd) in terms of progression free survival (PFS) in patients with multiple myeloma who have~     relapsed after 1 to 3 prior therapies.~   "
31200|NCT03158675|"~     Vitiligo is an acquired disease with a variable course. It is characterized clinically by~     well-defined depigmented macules or patches thought to occur secondary to melanocyte~     dysfunction and loss. it is the most common depigmentation disorder, affecting approximately~     0.5 to 2.0 percent of the population and has no predilection for gender or race .~   "
31201|NCT03158662|"~     This survey intends to collect information on key aspects of life with epidermolysis bullosa~     (EB), including diagnostic journey, treatment, management, daily living challenges, and~     overall psycho-social, socio-economic, academic and family impact.~      Objectives:~        -  To understand the unmet needs for people living with EB in the US~        -  To assess the differences/similarities in the management/treatment of EB patients~          (including wound care, symptom management and other issues)~        -  To assess the EB patients' and caregivers' perceptions of current management/treatment~        -  To assess the challenges and the burden of daily living with EB~        -  To understand EB diagnostic journey (the time to diagnosis and by what type of~          healthcare provider)~        -  To identify professional disciplines involved in the diagnosis and management of EB~        -  To understand the psycho-social, socio-economic, academic, and family impact of EB~   "
31202|NCT03158649|"~     The identification and treatment of the disorders connected to the perinatal period has~     traditionally catalyzed the researchers' attention. Nevertheless, since the World Health~     Organization has recently coined the concept of positive pregnancy experience, which includes~     not only treatment of diseases, but also health education, and health promotion, research on~     antenatal care has expanded to a salutogenic perspective. In the wake of this perspective, a~     growing number of research have been examining the potential benefits of positive aspects and~     protective factors on maternal prenatal well-bein. This salutogenic perspective is supported~     by the emerging field of Positive Psychology. Evidence from Positive Psychology studies has~     shown that it is possible to build and enhance personal strengths, sense of meaning and~     positive feelings by practicing some brief positive exercises, called Positive Psychology~     Interventions (PPIs). Recently, researchers have started to investigate the effects of a PPI~     on women's prenatal well-being, reporting promising findings in terms of potential direct~     effects of the positive intervention on women's prenatal stress in comparison to a~     treatment-as-usual control condition. In the past decade, many web-based delivered~     interventions have been designed and documented to be effective for the promotion of mental~     health and for the prevention and treatment of different disorders. Indeed, recent systematic~     reviews provides preliminary evidence that web-based interventions can be a promising and~     advisable form of intervention during the perinatal period. PPIs have been translated also in~     the online format. Preliminary evidence suggests that online positive psychology~     interventions can effectively enhance well-being and reduce depressive symptoms.~      The research team have developed the protocol for a web-based positive psychology programme~     addressed to promote and enhance women's prenatal well-being. This intervention programme~     will last five weeks and will be completely self-administered. It is intend to study the~     effect of the intervention on levels of mental well-being, depression, pregnancy related~     anxiety and other relevant variables, and the results will be compared to a waiting list~     control group.~   "
31203|NCT03158636|"~     The era of precision medicine is an exciting time for clinicians, scientists and patients~     alike. The increasing appreciation and identification of specific mutations that drive~     cancers, leaves us on the threshold of a new era in which biomarkers will be used to direct~     targeted agents to only those patients most likely to respond. The potential medical and~     scientific benefits of such a personalised approach to cancer therapy are immense. However, a~     number of barriers challenge successful implementation of this approach of which spatial and~     temporal heterogeneity are a major concern.~      Gynaecological cancers are a major cause of mortality and morbidity internationally. In~     Auckland 150 new patients with ovarian, endometrial or cervical cancer are seen by a medical~     oncologist each year. In general, when these diseases recur, there are few effective~     therapeutic options and prognosis is poor. Better therapeutic targets and treatments are an~     unmet need across these tumour types with treatment paradigms still based upon platinum based~     therapy.~      PROSPER (Profiling of Oncology Patients as part of Clinical care and Research) will~     investigate the evolution of gynaecological cancers over time and in response to treatment to~     develop better biomarkers to guide treatment decisions and ultimately improve patient~     outcomes. Biopsies at relapse will be collected and profiled with a 580 cancer gene panel.~     Circulating tumour DNA will be collected and analysed alongside biopsies as a potential~     non-invasive alternative. Linking genomic and clinical data will allow us to learn more to~     begin to change our paradigm of care.~   "
31204|NCT03158623|"~     3 cohorts of total joint patient of 30 members each were randomized to receive PRP or~     Activated Collegen or no additive were studied for status of the wound at 6 weeks and~     recorded all complications, infections and reoperations. The three groups were than compared~     for statistical analysis~   "
31205|NCT03158610|"~     Based upon biological behavior, those mCRC patients who respond well (SD, PR or CR according~     to RECIST Criteria) after 16-18 weeks of standard doublet chemotherapy as induction may~     enrolled into this study, randomly divided into capecitabine metronomic group or standard~     dosage group. The duration of disease control after randomization(PFS2) and progression free~     survival from enrollment (PFS1) are primary endpoints. Meanwhile, the overall survival,~     safety and quality of life are secondary endpoints. Exploratory markers involving~     angiogenesis (serum VEGF, PDGF, Tie-1 and Tie2, etc) and immune function (CD clusters, serum~     tumor mutation burden(TMB), etc), are conducted via liquid biopsy.~   "
31206|NCT03158597|"~     This study aims to compare whole-blood microarray gene-expression profiling between patients~     with acute myocardial infarction and normal participants without cardiovascular diseases.~     Firstly, screening differentially genes of mRNA to perform gene ontology and pathway~     analysis. Secondly, predicting target genes regulated by microRNA and constructing~     coexpression network with mRNA. Thirdly, biological function experiment of microRNA. Finally,~     revealing pathogenic mechanisms associated with acute myocardial infarction.~   "
31207|NCT03158584|"~     safety and efficacy of intrathecal morphine in post operative pain relief in pediatric~     patients undergoing major abdominal cancer surgeries using different doses of intrathecal~     morphine (2 μg/kg , 5 μg/kg ,10 μg/kg).~   "
31208|NCT03158571|"~     Background. Gastric cancer (GC) is the world's second leading cause of neoplastic mortality.~     Genetic alterations, response to treatments and mortality rates are highly heterogeneous~     across different regions. In Chile, GC is the leading cause of cancer death, affecting 20 per~     100,000 people and >3,000 deaths/year. Clinical outcomes and response to one size fits all~     therapies are highly heterogeneous and thus a better stratification of patients may aid~     cancer treatment and response.~      Study design/methods. The Gastric Cancer Task Force (GCTF) is a Chilean collaborative,~     non-interventional retrospective study that seeks to stratify gastric adenocarcinomas (GACs)~     using retrospect clinical outcomes and genomic, epigenomic and protein alterations in a~     cohort of 200 patients. Tumor samples from the pathology department and the Cancer Center at~     UC Christus healthcare network at Pontificia Universidad Católica de Chile will be analyzed~     using a panel of 143 known cancer genes (Oncomine Comprehensive Assay) at the Center of~     Excellence of Precision Medicine (CEMP) in Santiago, Chile. Additionally, gene promoter~     methylation will be performed and selected clinically relevant proteins (e.g. PD-L1, Erb-2,~     VEGFR2 among others) will be assessed by Tissue Microarray, Epstein-Barr virus (EBV) status~     will also be assessed. Observations will be correlated to 120 clinical parameters, including~     general patient information, cancer history, laboratory studies, comorbidity index,~     chemotherapy, targeted therapies, efficacy and follow-up.~      Discussion. The development of a clinically meaningful classification that encompasses~     comprehensive clinical and molecular parameters may improve patient treatment, predict~     clinical outcomes, aid patient selection for clinical trials and offer insights into future~     preventive and/or therapeutic strategies.~   "
31209|NCT03158558|"~     The purpose of this study is to test an intensive, multi-couple group version of a couple~     therapy for PTSD delivered to active duty Service Members or Veterans with PTSD and their~     romantic partners in a single weekend retreat. The study will be conducted on or near Fort~     Hood in Kileen, Texas. Twenty-four couples will be treated with this therapy and assessed~     immediately before treatment, 1 month after treatment, and 3 months after treatment.~   "
31210|NCT03158545|"~     The purpose of this study is to investigate the effects of EPA- and DHA-enriched omega-3~     polyunsaturated fatty acid dietary supplements on cerebral blood flow during a series of~     cognitive, mathematical subtraction tasks and subjective ratings of task difficulty before~     and after 26 weeks of supplementation~   "
31211|NCT03158532|"~     The radial approach for a coronary angiography has became popular in several centers because~     of its simplicity and fewer complications. The radial artery occlusion (RAO) is the main~     inconvenient and impose a limitation of future use of the radial artery as an access site for~     catheterization in the future. Several strategies have been used to decrease the incidence of~     RAO (heparin, patent hemostasis, etc). Nitrates in intra-arterial have been widely studied in~     prevention of this spasm. Current data show that nitroglycerin intra-arterial at the end of~     the procedure reduce the incidence of RAO. The hypothesis that use of nitroglycerin at the~     start of catheterization would have the same effect was not tested.~   "
31212|NCT03158519|"~     The purpose of this study is to test the mechanics and feasibility of delivering an~     individualized intervention to increase physical activity in breast cancer survivors.~      In this study, researchers will test an intervention that uses a commonly worn activity~     monitor (i.e., global positioning system [GPS] enabled running watch) to see if they can~     prescribe specific ways to increase physical activity that are individually tailored to~     each participant. The goal is to help participants increase their daily physical activity~     without having to join a gym or other traditional fitness program. Researchers want to see if~     they can make specific recommendations (using an application that can be added to a cell~     phone, tablet and/or computer) on ways participants can slowly increase their activity based~     upon where they live and work and in a way that is tailored individually to them. For~     example, participants may be given a route to walk on their lunch break, or new place to park~     to allow for a longer walk to their job. The goal is to meet participants where they are in~     their current level of fitness, and to help them think of new and creative ways of increasing~     activity without the frustration of soreness or risk of injury. As they move more, the~     recommendations will increase with them.~   "
31213|NCT03158506|"~     This is an open-label, single center, 1-period study in healthy adult male subjects to assess~     absorption, metabolism, and excretion of HMS5552 after a single oral administration of 50 mg~     (90 μCi) of [14C]-HMS5552.~   "
31244|NCT03158103|"~     The purpose of this study is to test the safety and tolerability of the combination of~     pexidartinib and MEK162. This study tests different doses of pexidartinib in combination with~     different doses of MEK162 to see which dose combination of these drugs is safe and best~     tolerated in people.~   "
31245|NCT03158090|"~     This study is a prospective, noninteractive, observational, and longitudinal study aimed at~     assessing the treatment pattern and clinical outcome of acromegaly in China.~   "
31246|NCT03158077|"~     Retrospective observational study, multicentric with Spanish hospitals, in which a switching~     or change strategy with RAL and ABC / 3TC guidelines was used, in the48 weeks before the~     start of the study, in order to determine parameters of Effectiveness and security.~   "
31214|NCT03158493|"~     Recently, the Society of Critical Care Medicine (SCCM) and the European Society of Intensive~     Care Medicine (ESICM) have published new definitions of sepsis, known as Sepsis 3, based on a~     fairly robust analysis of large, essentially American, databases. In addition to the new~     definition, a new screening score was suggested, named quickSOFA (qSOFA). This score is~     positive if two of three variables are present: respiratory rate higher than 22 ipm, reduced~     level of consciousness and systolic blood pressure lower than 100 mmHg. Although the receiver~     operator characteristics (ROC) curves suggest an adequate predictive validity for the new~     score, a lot of controversy around its sensitivity as a screening tool mainly in settings~     with high mortality rates. Current national Brazilian data show that sepsis mortality in our~     country, especially in public hospitals from the Unified Health System (SUS), is very high~     and well above world mortality. The impact of using the qSOFA in these settings is not known.~     In this context, the present study aims to evaluate the potential impact of using qSOFA as a~     screening tool in Brazilian private and public institutions. The hypothesis is that the use~     of qSOFA as a screening tool will have a low sensitivity. As a consequence, patients with the~     diagnosis of sepsis, with organ dysfunction, will not be detected by this tool. The~     hypothesis was also that those patients with a qSOFA negative will have a high mortality~     rate, mainly in Brazilian public hospitals.~   "
31215|NCT03158480|"~     Cytokine-induced killer (CIK) cells will be co-cultured with HPV induced dendritic cells~     (DCs); HPV specific DC-CIK will be induced to Condylomata Acuminata patients using~     interferon, whose recurrence rate and total cost will be compared to Condylomata Acuminata~     patients only use interferon.~   "
31216|NCT03158467|"~     We aim to examine the effect of an online advance directive on decisional conflict and~     quality of life in patients undergoing stem cell transplant. We also aim to assess the effect~     of palliative care at the time of a sentinel event on quality of life.~   "
31217|NCT03158454|"~     The purpose of this study is to investigate whether patients undergoing surgical treatment~     (hip arthroscopy) of FAI syndrome will positively benefit from capsular closure, in terms of~     higher scores in validated patient reported outcome measurements, compared to a Group of~     patients with FAI syndrome where the capsule is left open at the end of the surgical~     procedure.~   "
31218|NCT03158441|"~     Introduction The most common breast cancer originates within the breast milk ducts, and is~     called ductal carcinoma. After the stage where the cancer is found only within the ducts, it~     invades the breast tissue beyond the ducts, and becomes invasive cancer (Infiltrating Duct~     Carcinoma). Breast cancer located within the ducts is called intra ductal carcinoma in situ-~     DCIS. DCIS is the developing cancer and usually does not metastasize. Another type of breast~     cancer originates within the breast lobules and is call lobular carcinoma.~      Recently at the Weizmann Institute, Prof. Hadassa Degani and her group developed and imaging~     technique using breast MRI. This technique allows to map the three-dimensional structure of~     the milk ducts in the breast. The method is based on measuring the random movement (Brownian~     motion) of water molecules (diffusion) in different directions in the breast tissue,~     collecting diffusion images by using magnetic field gradients in different directions,~     allowing imaging of Diffusion tensor Imaging -DTI. Movement of water molecules within a~     unified solution is usually random and uniform in all directions, but the internal structures~     in biological systems (such as cells, pipelines, fiber) restrict the movement of water in~     certain directions. The DTI method exploits this feature by measuring the diffusion in~     various directions, thus enabling calculating images of biological structures [1]. This~     method was proved to be effective in mapping the brain's white matter fibers and is used~     routinely in clinical tests used to monitor neurological injuries [2-4]. This method was used~     for milk ducts mapping within breast tissue at the Weizmann Institute. The system that was~     developed at the Weizmann Institute, showed that the movement of water molecules along the~     milk ducts is faster than their movement across the ducts and therefore it was possible using~     this method to map the breast ductal system. Also this method showed that it is possible to~     detect and diagnose malignant changes within breast and to distinguish them from normal~     tissue and benign tumors using DTI. Changes in cell density and arrangement causes changes in~     the directional diffusion coefficients and the differences between them [5-9] Research Plan~     Summary A prospective preliminary study to evaluate the correlation between the DTI analysis~     of breast MRI and the results of conventional contrast enhanced breast MRI.~      The patients enrolled for the study will be women scheduled for breast MRI due to high risk~     screening or pretreatment evaluation. The patients will fill in a form regarding: age,~     hormonal status, risk factors, prior breast surgery or treatment (a form which is routinely~     filled out in our institution). They will then undergo a breast MRI scan, using the routine~     protocol in our institution. This will be directly followed by a DTI sequence, which takes~     about 10 minutes in addition to the regular examination. The DTI sequence is routinely used~     in other imaging institutions, as part of the breast MRI protocol.~      The exams will be read on our regular work stations, and in addition will be analyzed by~     software developed at the Weizmann Institute. Both interpretations will then be compared to~     each other and to clinical and pathological data~   "
31219|NCT03158428|"~     This study will evaluate exposure to tobacco constituents from two moist snuff products, and~     provide a basis for comparing mouth-level exposure (MLE) in moist snuff users after use of~     each of the two moist snuff products.~   "
31220|NCT03158415|"~     The purpose of this mixed-methods study is to explore the lived experience of parents of~     young adults ages 18 to 25 years with type 1 diabetes who are transitioning to independence,~     and to test the preliminary efficacy of a mobile education program to reduce parental~     distress.~   "
31221|NCT03158402|"~     This study evaluates the impact of preoperative high-intensity inspiratory muscle training~     (IMThi) before cardiac surgery on perioperative inflammatory response. Half participants will~     receive high intensity inspiratory muscle training and the others a sham inspiratory muscle~     therapy.~   "
31222|NCT03158389|"~     The objective of N²M² is the improvement of overall survival of patients with glioblastoma~     with an unmethylated MGMT promoter based on molecular characterization and use of targeted~     compounds in a modern trial design. The progression-free survival rate at six months (PFS-6)~     will be used to make decisions.~   "
31223|NCT03158376|"~     To assess the effects of prolonged preoperative gabapentin treatment (10 days) on chronic~     pain after thoracotomy.~   "
31224|NCT03158363|"~     The investigators want to establish a new model of acute febrile disease by mimicking the~     conditions seen in hospitalized patients in regards to inflammation, immobilisation and~     fasting. In this new model of disease, healthy young adults will be given lipopolysaccharide~     (LPS) to induce endotoxemia and inflammation/fever and then fast and bedrest for 36 hours.~     Glucose, fat and protein metabolism will be investigated using clamp technique and tracer~     methodology together with intracellular signalling pathway activation in muscle and fat~     biopsies. This new model of disease will later be used in another study to investigate~     different protein supplement´s effect on muscle waste during acute febrile disease.~   "
31225|NCT03158350|"~     Toothbrush plaque removal, along with interproximal flossing, helps to maintain the oral~     cavity free from periodontal diseases and dental caries. Although techniques such as the Bass~     Technique (BT), the Modified Bass Technique (MBT) and the Modified Stillman Technique (MST)~     are taught to dental students, dental hygiene students, and dental assistants, there is~     little evidence to discern which technique is more effective in reducing or preventing~     gingival inflammation.~      At Tufts University School of Dental Medicine (TUSDM), a modification of the Bass~     intrasulcular technique is advocated to many students. We call this modification of the Bass~     technique a Stationary Bristle Technique (SBT), which is an intrasulcular technique that~     maintains the toothbrush bristle ends essentially stationary on the tooth cervically and in~     the gingival crevice.~      In this study, half of the participants were taught the Stationary Bristle Technique Group,~     while the other half were not be provided with instructions, but asked to brush as normal~     (non-interventional group) throughout the duration of the study.~   "
31226|NCT03158337|"~     While it is well established that physical inactivity is a modifiable risk factor for~     vascular disease and cognitive decline, the mechanism by which exercise exerts its protective~     effect on the cerebral circulation and cognition is unknown. This knowledge gap was~     recognized recently in the Centers for Disease Control & Prevention and the Alzheimer's~     Association document National Public Health Road Map to Maintaining Cognitive Health. Our~     rationale for these studies is that the identification of physical exercise as a lifestyle~     factor able to improve cerebrovascular reserve and cognition would establish a strong~     scientific framework justifying design of a randomized clinical trial that could evaluate the~     role of physical activity in cerebrovascular health and function.~      This research is based on data we obtained from a cross-sectional study that showed~     significant relations between physical fitness, vascular regulation and cognition.~     Cerebrovascular reserve and cognition were better maintained in women who were physically~     active but reduced in women who were sedentary. Our central hypothesis is that regular~     aerobic exercise mitigates age-related decreases in cerebrovascular reserve, which in turn~     imparts benefits in cognition. Further, we believe that these effects will persist after the~     structured aerobic exercise program is terminated.~      Our 18 month study began with a 6-month baseline period, followed by a 6-month exercise~     intervention, and a 6-month follow-up period. In addition, there are 5-year and 10-year~     follow-up periods. Volunteers (men and women aged ≥ 55 years) from the community were~     recruited using a variety of recruitment methods including media and distribution lists.~     After the baseline (pre-training) measurements, participants underwent a six-month aerobic~     training program, following guidelines previously used by us and according to the new~     exercise guidelines for older adults established by American College of Sports Medicine and~     the American Heart Association. The study involves comprehensive assessments of physical~     fitness, cerebrovascular responses to carbon dioxide at rest and during sub-maximal exercise,~     and an extensive battery of cognitive function tests.~   "
31232|NCT03158259|"~     The objective of this study is to investigate the effectiveness of prehospital diagnosis and,~     when appropriate, of intravenous thrombolytic treatment of ischemic stroke. At the same time,~     we will take the opportunity to do an explorative study with the aim to further improve the~     intervention by biomarkers, and outcome measures volumetric measured by MRI images.~      The intervention study aim to:~        -  Determine the time from symptom onset to thrombolytic treatment in the Mobila Stroke~          Unit (MSU) compared to the conventional model~        -  Determine the number of patients receiving thrombolytic treatment within the 4.5 hrs~          window in the MSU compared to the conventional model~        -  Determine if thrombolytic treatment in the MSU, when adjusted for time, results in~          better mRS- and Barthel outcome compared to treatment in the conventional model The~          explorative study aim to~        -  Determine if final IS infarction volume estimated by MRI, is independently correlated~          with time from symptom onset to thrombolytic treatment~        -  Define cut-off values for GFAP and RBP4 combined that with sufficient specificity and~          sensitivity can distinguish ICH from IS~        -  Determine the influence of time to treatment on pro-inflammatory markers after stroke~      Hypothesis Intervention study I. The Treat - NASPP MSU model is feasible and reduces onset to~     treatment time less than 15 min II. The number of patient treated with thrombolysis within~     4.5 hrs of symptom onset is significantly increased in the Treat-NASPP MSU model III.~     Treatment in the Treat-NASPP MSU model does not result in increased day 90 mRS and Barthel as~     compared to the conventional model when adjusted for time IV. Prehospital thrombolytic~     treatment of stroke does not increase the risk of secondary cerebral bleeding as compared to~     in-hospital thrombolytic treatment of stroke (cerebral bleeding worsening within 36 hrs less~     than 4 per cent, Norsk hjerneslagregister) Explorative study V. The final infarct volume,~     estimated by MRI, is significantly reduced when thrombolytic treatment is initiated already~     in the MSU VI. Biomarkers is a valid tool in the hyper acute phase of cerebral illness to~     exclude contraindication to thrombolysis VII. Reduced onset to treatment time results in~     lower levels of selected pro-inflammatory molecules~   "
31233|NCT03158246|"~     This study compares the efficacy and safety of generic zoledronic acid (Yigu®) and original~     zoledronic acid (Aclasta®) in the treatment of postmenopausal osteoporotic women in China.~     Four hundred and sixty-six subjects will be randomised (1:1ratio) to either Yigu® 5mg IV or~     Aclasta® 5mg IV treatment arms.~   "
31234|NCT03158233|"~     This prospective, surveillance study will assess the operational Zika virus definition for~     use in future Zika purified inactivated virus (ZIKV) vaccine efficacy trials in order to~     identify Zika virus disease (ZVD) cases among the study cohort.~   "
31235|NCT03158220|"~     This study will assess the safety and immunogenicity of GARDASIL®9 (V503) in 27- to~     45-year-old women, and will complete the evaluation of GARDASIL®9 in the extended age range~     of female participants for whom GARDASIL® was proven to be effective. The primary hypothesis~     of the study states that anti-HPV 16, 18, 31, 33, 45, 52, and 58 titers at 4 weeks postdose 3~     are non-inferior in adult women as compared with titers in young adult women.~   "
31236|NCT03158207|"~     Positive pressure ventilation can be life saving for patients who are hypoxic, hypercapneic~     or apneic. Manual ventilation with a facemask is a skill that is routinely required for~     emergency medical technicians, respiratory therapists, nurses and physicians. Although mask~     ventilation skills are routinely taught, even the most skilled and experienced~     anesthesiologists struggle to effectively mask-ventilate.~      The effective use of a standard mask requires the simultaneous establishment of a seal~     between the mask and face and the lifting of the jaw. The preferred grip is referred to as~     the C&E technique. The C&E technique requires the index finger and thumb to form a C and~     push down on the mask to establish a seal between the mask and face. The lateral three~     fingers form the E and wrap under the jaw to provide lift. The grip required to establish~     the seal and jaw lift simultaneously is awkward and difficult to teach. The basic design of~     the standard facemask has not changed in approximately 100 years.~      This study will evaluate a new mask design, Warters Mask, is based on a novel design that~     allows a far more ergonomic grip. The C&E technique is replaced by a more natural grip. With~     the Warters Mask, downward pressure with the palm of the hand centered on the mask provides~     the seal between the face and the mask. The other four fingers align under the jaw to provide~     lift.~   "
31237|NCT03158194|"~     This is a study to develop a protocol on Cognitive behavior therapy (CBT) for asthma-related~     anxiety that in a consecutive study can be translated to internet-delivered CBT.~   "
31238|NCT03158181|"~     The aim of this interventional study is to optimize the movements and discipline of surgical~     staff in order to improve the quality of care, the safety of the patient in the surgery and~     to prevent the postoperative complications in the broad sense and in particular the infection~     of the surgical site. The intervention will be carried out using tools of new technologies~     allowing the monitoring of the movements and the sound level associated with techniques of~     behavior change inspired by those used in the human and social sciences.~   "
31239|NCT03158168|"~     Warts are common and infectious viral diseases of the skin and are prevalent worldwide. Warts~     are caused by the human papilloma virus (HPV), which has more than 100 strains; some of them~     are known to be premalignant .Although warts can appear at any age, they are more common in~     children and adolescents. The prognosis of warts cannot be predicted. In some patients they~     may spontaneously disappear, whereas others show persistence and progression with spreading~     to other body sites, leading to physical and emotional distress to the patients. [ 1 ].~   "
31240|NCT03158155|"~     To detect the effect of vitamin D deficiency in the development of early childhood caries~     (ECC) among Egyptian children.~   "
31241|NCT03158142|"~     Atropine eye drops are increasingly prescribed for the management of progressive myopia or~     short-sightedness. A previous study suggested that the back of the eye or choroid may be a~     part of the mechanism by which it induces its effects.~      The aim of this study is to characterize the effects of atropine on choroidal thickness and~     the influence of time of administration (am vs pm). It is hypothesized that the atropine's~     effect on choroidal thickness will vary with baseline thickness related to diurnal rhythm,~     where thicker baseline thickness will show a reduced choroidal response.~   "
31242|NCT03158129|"~     The goal of this clinical research study is to compare nivolumab alone to nivolumab plus~     ipilimumab when given to patients with non-small cell lung cancer (NSCLC) that can be~     surgically treated.~      Researchers want to learn how effective both study treatments may be in helping to control~     NSCLC after surgery.~      This is an investigational study. Nivolumab is FDA approved and commercially available for~     the treatment of NSCLC that has spread. Ipilimumab is FDA approved and commercially available~     for the treatment of melanoma. Combining these drugs is investigational.~      Your doctor can explain how the study drugs are designed to work.~      Up to 66 participants will be enrolled in this study. All will take part at MD Anderson.~   "
31243|NCT03158116|"~     This is a prospective, case-control clinical trial using inhaled Aztreonam (AZLI) in~     pediatric patients with a tracheostomy tube colonized with Pseudomonas aeruginosa. The aim of~     the study is to see if AZLI being taken in a one month on / one month off cycle over the~     course of a year can decrease the need for systemic antibiotics and/or hospitalizations.~   "
31247|NCT03158064|"~     The purpose of this study is to test the safety and effectiveness of durvalumab with~     tremelimumab in patients with relapsed or refractory germ cell tumors.~   "
31251|NCT03158012|"~     Unlike healthy control skin, the skin of patients with atopic dermatitis (AD) is frequently~     colonized by Staphylococcus aureus (S. aureus), putting these patients at increased risk of~     S. aureus skin infections. In addition, research in the investigator's lab has shown that~     these patients have fewer protective antimicrobial Staphylococcal species such as~     Staphylococcal epidermidis (S. epidermidis) that are known to produce antimicrobial peptides~     that play a role in protecting the skin from invading pathogens. In this study, the~     investigator will attempt to decrease S. aureus colonization and increase colonization of~     protective Staph species in AD patients. First the investigator will capture the bacteria on~     subjects' skin. Next the investigator will selectively grow the subject's antimicrobial~     Staphylococcal colonies and place them into a base moisturizer. The moisturizer plus bacteria~     will be applied to one of the subject's arms for one week. Some subjects will receive~     placebo, which is the moisturizer alone (without bacteria). The investigator will then swab~     the arms at specified time points during and after the one week application in order to~     determine whether the S. aureus abundance was affected by the application of the transplanted~     bacteria.~   "
31252|NCT03157999|"~     The aim of this study is to test a support program for older adults with symptoms of~     depression and other chronic health problems after they are discharged home from hospital.~     The study will be conducted in three communities in Ontario (Sudbury, Burlington, and~     Hamilton) and the program will be implemented with input from community members. The program~     will be delivered by a Registered Nurse, who will provide support to patients via home visits~     and telephone calls. The nurse's role will involve linking patients and their caregivers with~     needed services and supports, reviewing medications that the patients are taking, assessing~     patients' health, building the skills of patients in problem-solving and managing their care,~     and providing education to patients and their caregivers.~   "
31253|NCT03157986|"~     Aim of this study is to compare the effects of whole-body Vibration Training versus~     conventional Balance Training on Balance performance, gait quality and exercise capacity in~     patients with severe chronic obstructive pulmonary disease. Patients will be recruited during~     a 3-week inpatient pulmonary rehabilitation program and will be randomized into one of two~     intervention groups. On top of a standardized endurance and strength Training program (5 days~     per week) patients in both groups will perform an additional Balance Training (on 3 days per~     week). Patients in both Groups will perform the same 4 different Balance exercises (2x1~     Minute each): dynamic squats with closed eyes, heel raise, semi-Tandem stance and single leg~     stance but on a different surface. The Vibration Training Group will perform the exercises on~     a side-alternating Vibration platform (Galileo) at frequencies between 15 to 26 Hertz and the~     control Group will perform exercises on instable objects like Balance pads. The degree of~     difficulty in both Groups will be individually adjusted and will be progressively increased,~     if possible.~   "
31254|NCT03157973|"~     This study evaluates the effects of an eHealth tool and psychosocial support on anxiety,~     depression and health-related quality of life in patients undergoing surgical treatment for~     abdominal aortic aneurysm (AAA). Participants in the intervention group will receive access~     to the eHealth tool and structured follow-up with a contact nurse, the control group will~     receive standard of care.~   "
31255|NCT03157960|"~     The metabolism of the monosaccharide fructose is less controlled than the metabolism of~     glucose, which will result in the metabolic product uric acid. Elevated serum uric acid~     levels are associated with increased risk, or worsening, of chronic kidney disease. The~     mechanisms by which uric acid have detrimental effects are not well defined, but may include~     an increase in reactive oxygen species and subsequent inflammatory activity. The aim of this~     study is to investigate the effects of uric acid, markers of oxidative stress and markers of~     inflammation following a low fructose load reflecting normal conditions. This is an~     interventional study. On six different occasions patients with chronic kidney disease,~     patients with type 2 diabetes and healthy controls will receive Blueberry drink, Coca-Cola or~     pure Fructose drink with similar amount of carbohydrates (140 kcal) with and without a high~     fat meal represented by a pizza (425 kcal).Serum samples and urinary samples will be~     collected.~   "
31256|NCT03157947|"~     A pilot study testing the effect of an in-visit English and Spanish language decision aid for~     Hispanic-Latino men using best practices of cultural tailoring to be used in urology~     practice. Subjects will be followed for approximately 1 year during standard care in-clinic~     office visits. Study results and subject surveys will be analyzed to determine clinical~     utility of the tool.~   "
31257|NCT03157934|"~     FAST is an investigator-initiated multicenter study embedded in a German multistate acute~     stroke network. The main objectives of the FAST study are to improve outcomes and quality of~     care for stroke patients, to quantify the number of patients in need of thrombectomy within~     an integrated stroke network, to study the best way of delivering and performing thrombectomy~     and to investigate the best model of pre-hospital selection and referral for stroke patients.~   "
31258|NCT03157921|"~     Polycystic ovary syndrome is the most common endocrine disorder in women of reproductive age,~     with a prevalence of approximately 5-10%. Polycystic ovary syndrome is diagnosed according to~     Rotterdam criteria by at least two of the following three key features: oligomenorrhea or~     amenorrhea; clinical and/or biochemical signs of hyperandrogenism; the presence of polycystic~     ovaries on ultrasound and exclusion of other endocrine disorders including~     hyperprolactinemia, thyroid dysfunction and congenital adrenal hyperplasia. Polycystic ovary~     syndrome is also associated with insulin resistance, obesity and disorders of lipid~     metabolism, as well as infertility, although these findings have not been addressed in the~     Rotterdam criteria. Polycystic ovary syndrome is the major cause of anovulatory infertility.~     The recent studies suggest that anovulation resulting from ovarian follicle abnormalities in~     Polycystic ovary syndrome patients are 2-fold of normal ovaries. Firstly, early follicular~     growth is excessive, thus women with Polycystic ovary syndrome are characterized by an~     excessive number of small antral follicles (2- to 3-fold of normal ovaries). Secondly, the~     selection of one follicle from the increased pool of selectable follicles and its further~     maturation to a dominant follicle does not occur. This second abnormality in the~     folliculogenesis can cause menstrual dysfunction presented as oligomenorrhea or amenorrhea.~     Historically, Polycystic ovary syndrome treatment has not been curative in nature, instead~     treatments focus on resolution of clinical manifestations of the disease.~   "
31259|NCT03157908|"~     Population mobility is frequent in South Africa and disrupts the continuity of HIV care.~     Postpartum, HIV-positive women are at elevated risk of dropping out of HIV care and are~     highly mobile. This pilot study aims to engage peripartum, HIV-positive women as potential~     users to evaluate a novel smartphone application to assist these women with linkage to new~     HIV facilities and prospectively describe the mobility of this population.~   "
31260|NCT03157895|"~     This study evaluates the efficacy of a self-directed parenting program called Connecting in~     reducing risk of substance use and other risky behaviors in young foster teens (ages 11-15).~     Half of the participants will receive services as usual from the foster system, while half~     will participate in the Connecting program. Connecting is a 10-week, self-directed parenting~     workbook with two digital video discs (DVDs). Families receive weekly telephone support as~     they complete the program.~   "
31261|NCT03157882|"~     To examine pediatric pain assessment in the Emergency Department~   "
31262|NCT03157869|"~     Motor learning occurs with structural and functional modifications in neural networks that~     meet a certain demand. The improvement of performance in diverse activities is a measure of~     learning, as well as the generalization and transference of this capacity. Transcranial~     direct current stimulation (tDCS) is a modulation technique of brain activity that modifies~     cortical excitability, causing changes in motor evoked potentials that influence motor~     learning. Modifications similar to the long-term potentiation, essential for learning~     processes, have also been described after applying tDCS. The primary motor cortex is the area~     of stimulation where there is more robust evidence in favor of increased motor learning.~     PURPOSE: to investigate the effects of anodic tDCS on the learning of sequential finger~     movements in young and healthy individuals.~   "
31263|NCT03157856|"~     In this study, we aim to evaluate the feasibility of anti-PSMA labelling to detect~     post-operative prostatic tissues by two ex vivo fluorescence techniques. We will evaluate the~     feasibility and detection of anti-PSMA labelling by:~        1. / the FEMTO-ST institute medical device,~        2. / the confocal microscope that will be used to measure fluorescence spectra of~          biological samples.~   "
31264|NCT03157843|"~     After reports from observational studies suggesting an association between acutely ill~     medical patients and venous thromboembolism (VTE), interventional trials with anticoagulants~     drugs have demonstrated a significant reduction of VTE during and immediately after~     hospitalisation. Although several guidelines suggest the clinical relevance of reducing this~     outcome, there is a low tendency to use anticoagulants in patients hospitalised for acute~     medical illness. This observational multicentre study wants to evaluate the incidence of~     venous thrombo-embolism in acutely ill patients hospitalized in internal medicine wards.~   "
31265|NCT03157830|"~     The primary objective of this study is to assess the efficacy of Ocrelizumab (OCR) in~     Relapsing Multiple Sclerosis patients who have been previously treated with natalizumab (NTZ)~     by evaluating relapse rate, progression on MRI and disability progression.~   "
31266|NCT03157817|"~     Investigation into the associations between sedentary behaviour, physical activity, body~     composition and cardiometabolic risk in COPD. A single assessment visit with fasting blood~     tests, body composition and strength measures followed by a week of activity monitor wear to~     record sitting time and physical activity. Cardiometabolic risk markers include fasting~     glucose, HBA1c, HOMA and lipids and blood pressure.~   "
31267|NCT03157804|"~     This is an open, Phase I / II clinical trial to evaluate the safety and efficacy of a~     hematopoietic gene therapy procedure with an orphan drug consisting of a lentiviral vector~     carrying the FANCA gene for patients with Fanconi Anemia of Subtype A .~      CD34 + cells derived from bone marrow and / or mobilized peripheral blood (fresh and / or~     cryopreserved) from patients with Fanconi subtype A (FA-A), will be transduced ex vivo with a~     lentiviral vector carrying the gene FANCA (orphan drug) . After transduction the cells will~     be inoculated in patients in order to restore their hematopoiesis with genetically corrected~     stem cells.~   "
31268|NCT03157791|"~     This Clinical Trial is being conducted to study the effect of oral simethicone on the~     presence of bubbles during colonoscopy. The purpose of this study is to find out what effects~     (good and bad) the addition of oral simethicone to bowel preparation has on the ability to~     visualize the colon mucosa (bowel) during colonoscopy.~   "
31269|NCT03157778|"~     Measured plasmatic concentration of pregnenolone and endocannabinoid in fasting conditions~     and over a meal in obese and normal-weight men subjects, to research a dysfunction in the~     negative feed-back between pregnenolone and CB1 ligand in obese subjects. This dysfunction~     could participate to the hyperactivity of endocannabinoid system saw in obesity.~   "
31270|NCT03157765|"~     Patients with a history of recurrent implantation failure who are planning a frozen embryo~     transfer (FET) are enrolled into the program. Patients are randomized to an endometrial~     biopsy prior to starting estrogen to prepare for the transfer of warmed vitrified embryos or~     to routine care.~   "
31271|NCT03157752|"~     In France, screening involves a routine test of papanicolaou in women aged 25 to 65 years. In~     the case of an abnormal Pap smear discovery, the diagnostic strategy is based in most cases~     in colscopy to allow cervical biopsies if necessary to obtain a histological diagnosis of~     high quality cervical intraepithelial neoplasia (CIN) (2- 3) which, if persistent, can cause~     cervical cancer. Their results, also in the case of the persistence of a low-level lesion or~     of a cyto-histological discordance, indicate conization. Conization is a procedure performed~     by resection of the diathermic grip, allowing a simple and fast gesture compatible with a~     load under local anesthesia. In order to simplify the overall cost of the patient, more and~     more conizations of Montpellier and Nimes take place under local anesthesia. .~      The main objective of our study is to evaluate the overall satisfaction of patients in the~     case of conisation under local anesthesia.~      The goal is to promote local anesthesia for the management of congested patients, which~     simplifies overall management, reduces cost and reduces complications associated with general~     anesthesia.~   "
31272|NCT03157739|"~     The purpose of the study is to develop, evaluate, and optimize MigraineManager, the first~     web-based comprehensive self-management tool for adolescents with migraine, their parents,~     and clinicians.~   "
31390|NCT03156179|"~     The proposed pilot study will enroll 33 adolescent females with type 1 diabetes for the~     assessment of whole body calcium metabolism using dual stable calcium isotopes. This is the~     state of the art technique for assessing calcium metabolism in the body and has been used in~     both healthy and diseased pediatric populations.~   "
31273|NCT03157726|"~     The study is a multicentric randomized control trial with 4-year follow-up comparing~     perioperative and postoperative outcomes for transurethral plasmakinetic enucleation of~     prostate(TUKEP) and transurethral resection of prostate(TURP). The investigators recruit~     patient with benign prostatic hyperplasia(BPH) as the object of study. TURP is set as control~     group . Meanwhile TUKEP is set as test group. Six affiliated hospitals will participate in~     this study. Through analyzing the perioperative and postoperative data between TUKEP group~     and TURP group, The investigators purpose demonstrating superiority of safety, efficacy and~     economic benefit in TUKEP group.~   "
31274|NCT03157713|"~     Financial incentives for motivating changes in health behavior, particularly for weight loss~     in obese individuals, are increasingly being tested by health insurers, employers, and~     government agencies. However, a key unanswered question regarding weight loss is how to~     structure these incentive programs to maximize their effectiveness, acceptability to~     patients, and economic sustainability. Focusing on obese patients living in neighborhoods~     with a high concentration of low socioeconomic status households, the investigators will~     compare the impact of financial incentives for weight loss on sustained weight loss, use of~     evidenced-based therapy, and quality of life, and they will determine their short-term and~     long-term return on investment.~   "
31275|NCT03157700|"~     This Phase II STTR will evaluate an interactive, self-paced, e-learning media literacy~     intervention, REAL media, to prevent youth substance use among youth in the 4-H organization.~     Participating 4-H clubs will be randomly assigned to use the curriculum or continue current~     practices with the option for delivery at the end of the study. 4-H members (ages 13-15) will~     complete a pretest, immediate posttest and follow-up posttests at 3 and 9 months to assess~     effects.~   "
31276|NCT03157687|"~     This study should reveal differences in composition of luminal and mucosa-associated~     microbiome of the human gastrointestinal tract.Therefore bacterial species of different~     intestinal location sites (small intestine and colon) isolated of biopsies were compared to~     bacterial composition of stool samples. Additionally the bacterial composition of healthy~     persons, patients with inflammatory bowel disease and with liver disease (liver cirrhosis)~     will be compared to detect influence of local and systemic inflammation on microbiome.~   "
31277|NCT03157674|"~     This study will be focused on HNC patients who have been diagnosed with HNC between~     01-Jan-2013 and 30-Sep-2016.~   "
31278|NCT03157661|"~     Hypertension is a major medical and public health burden throughout the world. It is~     estimated that 1 in 3 adult South Africans are diagnosed with hypertension, however detailed~     statistics reflecting the burden of disease are somewhat lacking. The implications and~     effects of poorly controlled hypertension and its associated co-morbidities are significant~     and extensive. In South Africa, hypertension is the single most prevalent cardiovascular risk~     factor and predominant contributor to cardiovascular disease and mortality.~   "
31279|NCT03157648|"~     Shivering is a physiologic response to early hypothermia in mammals. The definition of~     shivering is an involuntary, oscillatory muscular activity that augments metabolic heat~     production.~      Routinely in post anesthetic care unit (PACU), the core temperature via tympanic membrane is~     always measured in all patients. Sometimes patients who have low temperature have no~     shivering symptom in other hand patients who have normal temperature have shivering symptom.~     This indicates that, only core temperature is not enough for predicting or detecting patients~     who will have shivering symptom in PACU.~      In this study, investigators hypothesise that the core-peripheral temperature difference in~     postoperative period indicates patients who will have shivering symptom.~      Thus, the aims of this study are to evaluate the relationship between core-peripheral~     temperature difference and shivering symptom in patients in PACU.~   "
31280|NCT03157635|"~     This is a Phase I/II, first-in-human study consisting of 3 sequential parts and an open-label~     extension (OLE) in which the safety, tolerability, pharmacokinetics (PK), and~     pharmacodynamics (PD) of single-doses of RO7112689 will be evaluated in healthy volunteers~     (HV) during Part I, and safety, tolerability, PK, and PD of RO7112689 will be evaluated in~     participants with PNH during Parts 2, 3, and OLE of the study. Efficacy of RO7112689 will be~     evaluated in Parts 2 and 3.~   "
31281|NCT03157622|"~     Exploration of treatment processes during exposure and cognitive-behavioral therapy in the~     context of chronic low back pain in a multiple baseline single-case design.~   "
31282|NCT03157609|"~     The present study aims to assess the accuracy of the SpotOn™ Zero-heat-flux-thermometry~     sensor in measuring core temperature in the paediatric population in the perioperative~     period.~   "
31283|NCT03157596|"~     Considering the impact of caregivers' oral health knowledge, attitudes and practices on the~     oral health of their children; we introduced an educational program to the parents and~     caregivers of children with developmental disabilities about the oral healthcare of their~     developmentally disabled children to rise up with the oral health status of those children.~   "
31284|NCT03157583|"~     The purpose of this study is to determine the SPF and UVAPF of four sunscreen formulations~     using international standard methodologies ISO24444:2010 for SPF and ISO24443:2012 for UVAPF.~   "
31285|NCT03157570|"~     Studies with exercise intervention aimed to improve the bone health and muscle functions in~     patients with AIS were lacking. Evidence suggested that low bone mass and low muscle mass~     were associated with curve severity and occurrence of AIS. Weight-bearing exercise that aimed~     to improve musculoskeletal and metabolic health could enhance bone health and muscle mass,~     and could provide a feasible alternative conservative treatment to prevent curve progression~     as well as the quality of life in AIS girls. This is a pilot feasibility study for future~     large randomized controlled trial (RCT) aiming at determining the effects of home based~     exercise program on improving bone mineral density (BMD), muscle mass and functions, quality~     of life (QoL), and prevent curve progression in skeletally immature girls with adolescent~     idiopathic scoliosis (AIS).~   "
31310|NCT03157232|"~     In this study, the concentration of hemoglobin was measured using noninvasive pulse oximeter~     sensors and compared against the hemoglobin measurement from the subject's blood sample under~     controlled conditions. Data collected in the study was in the sub-range of 11-17 g/dL in the~     device's 8-17 g/dL specification range.~      The purpose of the study was to evaluate a change in the sensor component and to assess~     performance equivalence in the sub-range. The performance of non-invasive hemoglobin is not~     uniform across the accuracy range.~   "
31286|NCT03157557|"~     Introduction and rationale:~      Unhealthy eating habits and lack of physical activity are risk factors for many diseases~     (including metabolic syndrome) and contribute to a shortened lifespan of 15-30 years in~     people with severe mental illness (SMI). Literature, mainly including short-term hospitalized~     or outpatients, show strong positive effects of activation on both physical and mental~     health. However, studies in long-term care are limited. In recent years, implementation of a~     lifestyle enhancing treatment intervention in clinical settings in GGz Centraal has~     demonstrated to be effective. The question is whether this kind of lifestyle intervention in~     sheltered housing is applicable and effective.~      Objectives:~      This research aims to develop an appropriate lifestyle intervention for patients living in~     sheltered housing services of GGz Centraal, based on input of patients and directly involved.~     Does applying this lifestyle treatment result in a positive effect in health and quality of~     life of patients and what is the influence of contextual factors, personal- and disease~     characteristics?~      Study design:~      In this intervention study, we use an experimental design. Municipal locations are paired~     based on the number of participants to generate equal cluster sizes. These paired clusters~     are randomly allocated to the control or intervention arm by means of a random number~     generator by an independent person (not involved in this project). At the start of the~     lifestyle treatment patients in the experimental and control group are invited to participate~     in the baseline screening. After six months, following a post-test on all outcome measures.~      Treatment intervention:~      The intervention in this study consists of formulating a lifestyle intervention, by patients~     and directly involved, aimed at enhancing a more active and healthier lifestyle . After~     formulation of the plan (based on psycho education, nutrition and physical activity), it wil~     be executed for a six month period.~      Hypothesis:~      Hypotheses is that lifestyle enhancing treatment is associated with improved metabolic~     health, quality of life and reduced use of medication. Furthermore we expect that movement~     disorders and disease severity will be negative related in becoming more active.~   "
31287|NCT03157544|"~     The purpose of this project is to determine the effect of a multimodal non-pharmacological~     Pain Relief Kit on the pain, functioning, patient satisfaction, and opioid consumption of~     individuals suffering from an acute pain episode of chronic neck and/or low back pain over a~     3-week duration.~   "
31288|NCT03157518|"~     Obesity is a major health concern in the Deep South resulting in a growing number of~     metabolic disorders that strain the resources of our healthcare system. Obesity is recognized~     as a major risk factor for asthma. The Centers for Disease Control and Prevention (CDC) has~     stated obesity is associated significantly with the development of asthma, worsening asthma~     symptoms, and poor asthma control. This leads to increased medication use and~     hospitalizations.~      Variations in the airway microbiome are correlated with the risk for development of asthma,~     and populations of different bacteria vary by phenotype amongst severe asthmatics .~     Proteobacteria are found in greater proportion in asthmatic subjects relative to healthy~     controls (37% vs 15%) while non-asthmatic subjects have a relative abundance of Firmicutes~     (47% vs 63%) and Actinobacteria (10% vs 14%) compared to those with asthma . Amongst those~     with asthma, obese asthmatic subjects have a relative abundance of Bacteroides (54%) and~     Firmicutes (26%). Notably, both phyla are part of the gastrointestinal microbiome, suggesting~     inoculation through gastroesophageal reflux which may be more common in obese individuals.~     Asthmatics identified as having improvement in their asthma control following treatment with~     inhaled corticosteroids appear to have a greater relative abundance of Actinobacteria (79.8%)~     in their airways relative to other asthmatics. Actinobacteria have been associated with the~     production of anti-inflammatory proteins and are speculated to be involved in increasing~     steroid responsiveness. Other studies have demonstrated that oral administration of~     probiotics, including Bifidobacterium species within the phyla Actinobacteria, lead to~     reduced Th2 cytokine production and eosinophilic inflammation, along with promotion of~     Regulatory T-cell (Treg) populations within the airway. We hypothesize that administration of~     over the counter oral probiotics containing Actinobacteria (Bifidobacterium) to obese~     asthmatic subjects will result in decreased airway inflammation and better asthma control by~     immune modulation.~   "
31289|NCT03157505|"~     Local allergic rhinitis (LAR) is relatively new disease. The question of effect of allergen~     specific immunotherapy on LAR is open. The randomized, double blind placebo controlled trial~     of birch subcutaneous AIT on LAR were performed in twenty eight patients. The therapy was~     performed during 24 months in proportion 15 patients with AIT and 13 placebo. The primary~     endpoint was decreased of symptoms medication score (SMS). Additionally monitoring serum~     specific IgE, specific IgG4 and nasal specific IgE (nsIgE) to Bet v1 and parameters of safety~     and quality of life were provided.~   "
31290|NCT03157492|"~     This study evaluates the benefits of short-term training via telehealth for post-lingually~     deafened adult cochlear implant users. Half the participants will receive aural~     rehabilitation and the other half cognitive training. The hypothesis is that short-term aural~     rehabilitation via telerehab technology will improve outcomes for post-lingually deafened~     cochlear implant users~   "
31291|NCT03157479|"~     Background. The use of a comprehensive strategy providing low tidal volumes, peep and~     recruiting maneuvers in patients undergoing open abdominal surgery improves postoperative~     respiratory function and clinical outcome. It is unknown whether such ventilatory approach~     may be feasible and/or beneficial in patients undergoing laparoscopy, as pneumoperitoneum and~     Trendelenburg position may alter lung volumes and chest-wall elastance.~      Objective. The investigators designed a randomized, controlled trial to assess the effect of~     a lung-protective ventilation strategy on postoperative oxygenation in obese patients~     undergoing laparoscopic surgery.~   "
31292|NCT03157466|"~     Although it is now recognized that a variety of respiratory abnormalities, such as~     diaphragmatic dysfunction, can be present in primary hypothyroidism and reverse with adequate~     hormone treatment, the role of thyroid hormone replacement therapy on respiratory system in~     patients with the nonthyroidal illness syndrome (NTIS) remains to be clarified. The NTIS has~     been found to be an independent risk factor for prolonged (> 13 days) mechanical ventilation.~     It is unclear, however, whether the NTIS is only a biochemical prognostic marker or it~     actually contributes to the development and progression of respiratory failure.~      The aim of this study will be to assess respiratory muscle function after thyroid hormone~     substitution therapy in mechanically ventilated patients with the NTIS.~   "
31293|NCT03157453|"~     Prospective cohort study. Any patient with potential cerebral injured (medical or traumatic)~     will be included in the study, regardless of its severity, history, the presence of~     anticoagulant or antiagrégant.~      The collection should be done as soon as possible, in the reception of vital emergencies or~     in the urgencies. The collection consists of the realization of a Glasgow score and a scale~     of Kremlin-Bicêtre for all patients by completing a standardized collection sheet. The~     collection of GCS and Kremlin-Bicêtre must be did at the same time. The collection sheet is~     filled by medical personnel trained.~      The future of the patient is informed at 6 months using the Glasgow Outcome Scale- Extended,~     which will be made during a following consultation or by phone. Additional data will be~     collected on the folder (ventilation time, days of hospitalization, mortality).~   "
31294|NCT03157440|"~     An innovative ring type oxymetry will be wore by patient undergoing sleep study to validate~     it's accuracy and usefulness as a screening device for patients with symptoms of OSA~   "
31295|NCT03157427|"~     This study evaluates the performance of CRYOBEAUTY MAINS, a Cyto-selective Cryotherapy~     based on Difluoroethane as a treatment of Solar Lentigines in 30 volunteers. Only one~     application of CRYOBEAUTY MAINS in one hand (right or left hand according to the~     randomization code).~   "
31414|NCT03155867|"~     This will be a randomized, cross-over design. Subjects will be randomized to one of six~     interventions on six separate study days, 1 week apart.~   "
31296|NCT03157414|"~     This is a single-center, prospective, controlled, double-blind, randomized study. A total of~     50 renal transplant recipients diagnosed with post-transplantation diabetes mellitus (PTDM)~     will be included more than 1 year after transplantation and radomized 1:1 to empagliflozin~     (Jardiance®) 10 mg or placebo once daily for 24 weeks. Patients with estimated glomerular~     filtration rate below 30 mL/min will be excluded. Oral glucose tolerance test, 72h continuous~     glucose monitoring (iPro™2), measurement of arterial stiffness, body composition (including~     visceral fat), 24h blood pressure and 24h urinary glucose excretion will be performed at~     baseline and after 24 weeks in addition to standard safety measurements. Two safety visits~     will be performed at week 8 and 16. All concomitant medication, diet and exercise will be~     kept stable during the study period. The objective of the present study is to answer whether~     empagliflozin safely and effectively improves glucose metabolism together with weight loss in~     renal transplant recipients with PTDM.~   "
31297|NCT03157401|"~     To compare the two administration methods of tranexamic acid for patients undergoing the~     first unilateral THA, to explore the effects of tranexamic acid on perioperative blood loss~     from the aspects of dominant blood loss, hidden blood loss, blood transfusion rate, mean~     blood transfusion volume and safety so as to further clarify what kind of medication is more~     effective.~   "
31298|NCT03157388|"~     Alcoholic hepatitis (AH) is a severe alcohol induced hepatic inflammation that leads to~     jaundice and liver failure. Gut derived bacterial translocation to the liver is currently~     thought to be one of the main inflammatory drivers of the disease.~      This project investigates the effects of gut sterilisation with broad spectrum antibiotics in~     patients with AH~   "
31299|NCT03157375|"~     Age-related cataract is the main cause of impaired vision in the elderly population~     worldwide. In the UK, more than half of people who are over 65 years old have some cataract~     development in one or both eyes. The only treatment that can restore functional visual~     ability is cataract surgery where the opacified crystalline lens is removed by~     phacoemulsification and an artificial intraocular lens is implanted. It is estimated that~     around 10 million cataract operations are performed around the world each year. Cataract~     operations are generally very successful, with a low risk of serious complications.~      During the past two decades, cataract surgery underwent tremendous change and modernisation~     resulting in today's small incision phacoemulsification surgery and a safe technique with a~     short rehabilitation time for the patient. Traditional spherical monofocal intraocular lenses~     (IOLs) restore best-corrected vision and may lessen the need for spectacles. These IOLs~     correct only the spherical portion of the total refractive error and do not correct corneal~     astigmatism. Astigmatism is a visually disabling refractive error affecting the general~     population, especially those with cataract. At least 15% to 20% of cataract patients have 1.5~     diopters (D) or more of corneal or refractive astigmatism. With increased patient~     expectations, the trend is not only to remove the cataract but also to address the problem of~     pre-existing astigmatism at the time of surgery.~      Surgical-induced astigmatism can be reduced by smaller incisions, i.e. microincision cataract~     surgery (MICS), which by definition is surgery performed through incisions smaller than 2.0~     mm, reducing the need for suturing. This results in better corneal optical quality, thus~     improving visual outcomes. There are also other surgical options to correct preexisting~     astigmatism during cataract surgery like: selectively positioning of the phacoemulsification~     incision; astigmatic keratotomy with corneal or limbal relaxing incisions; excimer laser~     refractive procedures such as photorefractive keratectomy, laser in situ keratomileusis, and~     laser-assisted subepithelial keratectomy; or implanting pseudophakic toric posterior chamber~     intraocular lenses (IOLs).~      Toric IOLs have been shown to result in good visual and refractive outcomes. Combined with~     MICS, these IOLs can allow effective correction of cylindrical errors intraoperatively,~     improving visual quality and thus leading to spectacle independence. Plate haptic and loop~     haptic toric IOLs have been considered for about a decade but have been associated with~     postoperative rotational instability. Rotation of a toric lens from its intended orientation~     degrades its corrective power, with approximately 3.3% loss of cylindrical power for every~     degree off axis. A misorientation of approximately 30° negates the effectiveness of~     astigmatic correction, and a misorientation of more than 30° may induce additional~     astigmatism. Although some patients are asymptomatic despite induced astigmatism, others~     experience symptoms such as blurred or distorted vision, headache, fatigue, eyestrain,~     squinting, or eye discomfort. Thus, IOL orientation stability is an essential goal in toric~     IOL design.~      RATIONALE~      The purpose of this study is to assess the axial IOL rotation and optical quality~     (refraction, visual acuity, contrast sensitivity, decentration and tilt) and capsular bag~     reaction after micro-incision surgery with an IOL implantation in cataract patients - HOYA~     Vivinex iSert® model P261.~   "
31300|NCT03157362|"~     This experiment aims to examine the effects of transportation via social presence in near~     and far virtual environments, on pain threshold in two groups: 1. healthy volunteers in an~     induced pain task, and 2. older adults suffering from pain. In the first, pilot group, a~     within-subjects study, participants will complete a series of induced-pain heat ramps in~     virtual environments that are near or far—in other words, they will either duplicate~     their actual physical environment, or represent another location. A second factor in this~     experiment will be mediated social presence, in which participants interact with confederates~     as avatars in either condition. The hypotheses follow: H1: Participants who feel present in a~     remote location will have a higher pain tolerance than those in a near location. H2:~     Participants who feel socially present with a confederate will have a higher pain tolerance~     than those who are alone in a virtual environment. H3: There will be an interaction between~     social presence and virtual environment such that participants who feel socially present in a~     remote location will have the highest pain tolerance overall. Building on these results,the~     next step will be a long-term study on older adult pain patients. In this step, the most~     successful condition in the first study to lightweight, portable headsets that can be used~     outside of the lab environment. This intervention will be tested on older adult patients who~     are suffering from chronic pain.~   "
31301|NCT03157349|"~     The purpose of this study to compare the effect of Biofreeze® versus a Placebo on neck pain,~     disability, fear avoidance, and range of motion prior to and following cervical manipulation~     over the course of one week among patients with acute neck pain.~   "
31302|NCT03157336|"~     Investigators will implement a novel cassava processing method (wetting method, WTM) that~     safely removes cyanogenic compounds from cassava flour prior to human consumption in a~     stratified village-cluster randomized non-inferiority trial so as to compare the~     effectiveness of a peer-led intervention (women training other women in the WTM) with that by~     community-health worker specialists.~   "
31303|NCT03157323|"~     The study aims to determine the feasibility of a 6-month low glycemic dietary intervention in~     children and adolescents undergoing treatment for acute lymphoblastic leukemia.~   "
31304|NCT03157310|"~     Gefitinib is a selective small molecule epidermal growth factor receptors (EGFR) tyrosine~     kinase inhibitors (EGFR-TKI), it's curative effect on non-small cell lung cancer (NSCLC) has~     been confirmed by a number of prospective clinical trials. The researches aim to analysis~     whether bone metastasis could affect the survival of NSCLC patients who were effective in~     Gefitinib treatment over 6 months.~   "
31305|NCT03157297|"~     The purpose of this study is to characterize performance of the MARVEL algorithm downloaded~     into the MicraTM TPS to provide atrial synchronous ventricular pacing in subjects with AV~     block.~      A sub-study will be conducted within the Marvel study, the purpose of this study is to~     characterize the MARVEL algorithm in patients who were enrolled in the MARVEL study, and to~     collect and compare the accelerometer signals and AV synchrony at a second point in time.~   "
31306|NCT03157284|"~     This Study Evaluate the efficacy of the subministration of fermented rice flour (7 g/day) on~     the clinical course of patients with moderate or severe Atopic Dermatitis, in terms of a~     reduction in the SCORAD score, during the study period and four weeks after the suspension of~     the treatment.~   "
31307|NCT03157271|"~     Subjects between 14 and 40 years of age referred to physical therapy with a diagnosis of PFPS~     will be randomly assigned to one of two groups. The first group (PFPS) will be treated~     pragmatically. The second group (PFPS+DN) will receive the same pragmatic approach with the~     addition of dry needling intervention. The dry needling intervention will be delivered based~     on the treating physical therapist's examination of the patient's soft tissue mobility~     deficits, muscle activation deficits, or referred pain patterns.~   "
31308|NCT03157258|"~     People living with HIV infection (PLH) are clustered in friendship groups with other HIV+~     persons, and an intervention delivered to all members of PLH social networks allows HIV+~     people who are friends in day-to-day life to provide one another with support for entering,~     remaining, and adhering to HIV medical care. Moreover, an intervention delivered to groups~     attended by HIV+ persons who are friends increases HIV medical care engagement and decreases~     problem drinking more than individual counseling, probably because the network intervention~     harnessed mutual peer social support among friends who share the same HIV status, face~     similar coping issues, and interact together in day-to-day life. The planned research will be~     conducted in two phases in St. Petersburg, Russia.~   "
31309|NCT03157245|"~     The objective is to determine the incidence of thrombosis on central venous catheters in~     patients hospitalized in a surgical critical care unit, in the immediate postoperative period~     of urological or digestive carcinological surgery, and receiving parenteral nutrition.~   "
31311|NCT03157219|"~     Burden of HF in India is approximate 2-5 million patients with an estimated prevalence of~     2-3/1000 population. HF is responsible for approx1.8 million admissions annually in India.~     Very few studies are there in India which shows the detailed documentation of HF.~      Manipal Heart failure Registry (MHFR) is an institutional level Heart Failure disease~     registry. In MHFR the investigator will document the detailed information about heart failure~     patients admitted or referred to Department of Cardiology, Kasturba Medical College, a~     constituent college and teaching hospital of Manipal University.~      MHFR will include cohorts of patients with acute heart failure (AHF), with the intention of~     implementing a long-term follow-up, the use of health economic assessment to evaluate the~     degree of resource utilization; and quantifying the burden on quality of life for patients.~     Utilization of drug in HF patients will be evaluated as a part of this study to prevent the~     use of inappropriate drug therapy and to improve overall drug effectiveness and outcomes.~     Hence the protocol sought to identify the characteristics and long-term outcomes of Indian~     patients with acute heart failure admitted in an Indian tertiary care center in South India.~      There are no risks to patients participating in the registry study, as standard of care~     quality will not be affected. It is unlikely that there will be any direct benefit as a~     result of participation in the HF-disease registry. However, the information contained within~     this non-interventional registry study will be used for research studies directed at~     improving the knowledge and treatment of acute heart failure as well as improving patients~     treatment in the future.~      The potential impact of proposed research (Manipal Heart Failure Registry) is envisioned to~     be four-fold:~        1. to enable a broad overview of the routine medical practices for HF treatment;~        2. to assess the healthcare resource utilization and drug utilization review for heart~          failure patients~        3. to assess the burden of disease (mortality, re-hospitalization) in the long term; and~        4. to provide a novel overview of the impact of HF syndrome on quality of life as well as~          health economics.~   "
31312|NCT03157206|"~     Patients with diabetic macular edema treated with aflibercept injections for visual~     impairment will be observed in standard care during 12 months. They will undergo visual~     assessments by Ultrawide Field angiography at baseline and at 12 months~   "
31313|NCT03157193|"~     The effect of the hyaluronic acid treatment on peri-implantitis has not been tested. The aim~     was to analyze the effect of a hyaluronic acid-containing gel on the clinical variables and~     the expression of biochemical inflammatory markers in the crevicular fluid of implants~     receiving perimplantitis treatment.~   "
31314|NCT03157180|"~     Perioperative anaphylactic reactions are immediate, hypersensitive reactions that are~     potentially life-threatening resulting from a sudden release of mediators from mast cells and~     basophiles. Which is due to either immune (IgE or non-IgE mediated) or non-immune mechanisms.~     Pseudo-allergic are defined as those reactions that produce the same clinical symptoms with~     anaphylaxis but are not IgE mediated, occur through a direct nonimmune-mediated release of~     mediators from mast cells and/or basophils or result from direct activation.so~     pseudo-allergic reactions do not require previous contact with the substance. Recent studies~     have shown that a mast-cell-specific receptor,G-protein-coupled receptor MRGPRX2,is crucial~     for pseudo-allergic drug reactions.in this study. In the study, we will examine the MRGPRX2~     gene in patients with pseudo-allergic reactions during anesthesia, aiming at clarifying the~     relationship between pseudo-allergic reactions and MRGPRX2 gene.~   "
31315|NCT03157167|"~     To determine the safety of escalating doses of Tc 99m tilmanocept in HIV (human~     immunodeficiency virus) subjects with confirmed KS.~   "
31316|NCT03157154|"~     Life expectancy of haemophilia patients (specially severe) has dramatically increase in the~     last decades, which lead to the apparition of aging diseases such as cardiovascular disease,~     with the potential bleeding risk of antiplatelet therapies and anticoagulants.~      The primary endpoint of the study is to evaluate this bleeding risk in haemophilia patients~     (all severity) with such treatment in comparison to non treated patients, according to the~     number of bleeding events in the last year reported by the haemophilia patients under study~     treatment (antiplatelet and anticoagulant) in comparison to haemophilia patients free of such~     treatment. The main hypothesis is that antiplatelet and anticoagulant therapy can be safely~     used in minor haemophilia patients but might lead to increase bleeding risk in other~     haemophilia patients.~      Secondary endpoint consist in:~        -  Evaluate the impact of know cardio-vascular risk in haemophilia patients (Odd ratios=OR)~        -  Evaluate the number of sever bleeding event in patient under study treatments compared~          to the control group~        -  Evaluate the overall consumption of factor VIII or IX supply in patients under study~          treatments compared to control group~        -  Estimate the stenosis relapse risk in haemophilia patients with arterial STENT~        -  Estimate the embolic risk of haemophilia patients with atrial fibrillation~      Population description:~      Haemophilia patients (man, all severity)~      Age above 50 years, followed during the last 5 years in one of the study centre~   "
31317|NCT03157141|"~     Ankle osteoarthritis is a progressive degenerative joint disease that is characterized by~     severe pain, loss of autonomy, diminished health-related quality of life, functional~     disability and diminished physical ability to fulfill occupational duties of life in its~     end-stage. Current surgical treatments for ankle osteoarthritis are ankle arthrodesis and~     total ankle replacement. Despite the good pain relief provided by these procedures, patients~     are still experiencing post-operatively important functional limitations in their activities~     of the daily living which affect their independency and quality of life. In order to remain~     capable of performing primary activities of the daily living, those patients have to make~     functional compensatory adaptations in the ipsilateral adjacent joints that will cause~     additional degenerative joint disease in those joints.~      Currently, the outcome of foot and ankle surgery is primarily based on clinical, radiographic~     and questionnaire outcomes. However, these outcome measures have been criticized for not~     being sensitive enough to detect clinically meaningful change in foot function. To tackle~     these shortcomings, an advanced clinical examination platform integrating~     pressure-force-kinematic measurement devices was developed and showed its clinical value for~     the detection of intrinsic foot mobility impairments. Surprisingly, up-to-now, no study has~     included this integrated use of three-dimensional multi-segment foot models, plantar pressure~     platform and a force platform to report on the functional outcome of an ankle arthrodesis or~     a total ankle replacement.~      Therefore, a multi-centre study will be conducted with two foot & ankle surgery centres. Both~     centres are equipped with the same advanced clinical examination platform. It is believed~     that proposed approach has the potential to provide further insight in the true functional~     changes related to ankle arthrodesis and total ankle replacement. This may in turn result in~     improved rehabilitation, less risk for post-operative complications, earlier discharge and~     quicker resumption of normal activities of the daily living, which would make ankle~     arthrodesis and total ankle replacement more cost-efficient and could potentially affect~     thousands of patients each year. Therefore, the hypotheses of the present study are:~        -  Hypothesis (H1): Subjects with an ankle arthrodesis require a greater reorganization of~          foot and lower limb kinematic and kinetic patterns to respond to mechanical requirements~          of level walking compared to subjects with a total ankle replacement.~        -  Null hypothesis (H0): Subjects with an ankle arthrodesis do not require a greater~          reorganization of foot and lower limb kinematic and kinetic patterns to respond to~          mechanical requirements of level walking compared to subjects with a total ankle~          replacement.~   "
31318|NCT03157128|"~     This is a Phase 1, open-label, first-in-human study designed to evaluate the safety,~     tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of LOXO-292~     administered orally to patients with advanced solid tumors, including RET-fusion non-small~     cell lung cancer (NSCLC), medullary thyroid cancer (MTC) and other tumors with increased RET~     activity.~   "
31341|NCT03156829|"~     Trigger finger has a prevalence rate of up to 3%. There are many approaches available to~     manage this condition. While corticosteroid injection is widely accepted as the most common~     first-line treatment, its superiority over splint treatment has not been established. This~     study aims to test the effectiveness of cortisone injections, splint and cortisone+splint to~     resolve symptoms.~   "
31319|NCT03157115|"~     Measuring cardiac contractility is commonly realized with gold standard echocardiography or~     MRI. Portable devices to measure this contractility are not available as for rhythm and~     electric function assessment. The new Kinocardiography technology could provide a non~     invasive and portable tool to measure contractility.~      This device records the electric and mechanic function of the heart. With electrodes and~     adequate electronics, ECG is recorded. 6 degrees of freedom accelerometers are also included~     in the device to measure the micro accelerations of the body at the body surface when the~     device is placed on the skin. Using physics principles and adequate calibration, those~     accelerations allow the investigators to calculate parameters such as kinetics energies~     related to heart contractility. Kinocardiography is a non invasive and portable technology.~   "
31320|NCT03157102|"~     In France, over 2.5 million people suffer from asthma, including one-third of children. This~     is the chronic respiratory disease leading to the highest rate of hospitalization. The~     conventional oxygen delivery means in children are the non-rebreather face mask or low flow~     nasal cannula (standard oxygen therapy - SOT). New non-invasive ventilatory support systems~     such as High Flow Nasal Cannula (HFNC) are emerging. These are nasal cannulas allowing the~     delivery of a high air (or oxygen) flow, exceeding the inspiratory flow of patients with~     acute respiratory failure, allowing to deliver a slight positive expiratory pressure while~     ensuring humidification and warming of the airways. Aerosol administration is also possible~     with excellent efficiency and without interrupting respiratory assistance. Physiological data~     and clinical studies in other pathologies suggest the interest of this technique during the~     asthma attack, but no comparative study currently exists in this indication. The HFNCs could~     have their place upstream of Non Invasive Ventilation (NIV), thus replacing non-rebreather~     face mask sometimes not tolerated by the children. The investigators's hypothesis is that~     HFNCs could improve patients' health faster, reduce the use of other ventilatory assistance~     (NIV, invasive ventilation) and reduce the duration of hospitalization in intensive care~     units or continuous monitoring units (CMU).~   "
31321|NCT03157089|"~     The main objective is to assess the efficacy of afatinib in combination with pembrolizumab,~     as measured by objective response (OR) in patients with locally advanced or metastatic~     squamous NSCLC who progressed during or after first line platinum-based treatment.~      The secondary objectives are to confirm the RP2D, assess the safety profile, and the~     secondary measures of clinical efficacy including disease control (DC), duration of objective~     response (DoR), progression-free survival (PFS), overall survival (OS), and tumour shrinkage.~   "
31322|NCT03157076|"~     The study assesses the effect of Closed Loop Stimulation (CLS) on the ventilatory efficiency~     slope and estimates the patient responder rate to CLS in patients with severe chronotropic~     incompetence treated with a cardiac resynchronization therapy (CRT) device.~   "
31323|NCT03157063|"~     The goal of this study is to quantify energy metabolism using indirect calorimetry at rest,~     in the presence of excess energy following a meal, and in response to the demand for energy~     during exercise. The investigators also will examine the individual and joint associations of~     activity and obesity status on neurocognitive domains of appetite control. Participants will~     include adolescent males and females (N=80) using a 2 x 2 cross-sectional study design,~     stratified by body weight (normal vs overweight/obese) and physical activity level (sedentary~     vs. active).~   "
31324|NCT03157050|"~     the aim of this study is to assess whether increased ferritin after intravenous iron therapy~     will lead to increased prevalence of major depression among treated patients.~   "
31325|NCT03157037|"~     This study will evaluate the safety and tolerability of IdeS in patients with severe anti-GBM~     (Glomerular Basement Membrane) disease receiving standard care consisting of~     pulse-methylprednisolone, oral prednisolone and intravenous cyclophosphamide combined with~     plasma exchange (PLEX).~   "
31326|NCT03157024|"~     This is a single blind randomised controlled trial involving healthy volunteers to determine~     feasibility and blinding property of two types of sham press needles.~   "
31327|NCT03157011|"~     the investigators propose to carry out a prospective study consisting of a systematic~     research of digestive symptoms in patients with SGSp with the validated Global symptom score~     (GSS) questionnaire, which allowed to grades severity of 10 digestive symptoms (absent, mild,~     moderate, or severe), asthenia and fever.~   "
31328|NCT03156998|"~     An observational study to investigate the compliance of home nebulizer therapy among children~     aged 0-14 years old clinically diagnosed with asthma~   "
31329|NCT03156985|"~     DONATE study is a multi-center, prospective cohort, single arm, observational study to be~     performed in 3000 Chinese type 2 diabetes mellitus (T2DM) patients recruited from 100 tier 2~     or 3 hospitals, China.It is a drug intense monitoring study required by China Food and Drug~     Administration (CFDA) to assess the newly approved drug in at least 3000 patients within the~     first five years after commercial launch. The primary objective is to demonstrate the safety~     of dapagliflozin by assessment of the incidence of adverse events and serious adverse events~     during 6-month follow up in Chinese patients with T2DM.~   "
31330|NCT03156972|"~     Rhumatic heart disease patients with mitral regurge untile know had adibat for timming of~     surgical interferance our study aim to solve this problme using a new technic in~     echocardiography called speckle tracking which is more accurate in estimating a changes~     occure to myocyte of the heart and so chosing the proper time for surgery~   "
31331|NCT03156959|"~     Enhanced CBT (CBT-E) is an effective treatment for the majority of outpatients with an eating~     disorder; however in about 30% of patients remission is made difficult. This may be due to~     the concomitant presence of trauma. Therefore we expect that a combination of CBT-E and EMDR,~     which is the evidence based treatment for PTSD disorder, would enhance the remission~     probability. This trial has a parallel group randomized controlled design. All patients who~     will enter in contact with the Regional Reference Centre for Eating Disorders in Verona and~     will satisfy inclusion criteria will be randomized to the broad form of CBT-E (CBT-Eb) plus~     EMDR or CBT-Eb alone. Patients will be evaluated before the treatment, at the end of~     treatment and after 6 months post-treatment with a set of standardized measure to assess~     eating disorder symptoms and other possible predisposing and moderating factors. The efficacy~     of CBT-E vs CBT-E + EMDR will be evaluated at the end of the treatment and after 6 months in~     terms of global score of the Eating Disorder Examination. Moreover the changes in other~     secondary outcomes will be considered. This explorative study may suggest new hypothesis for~     larger RCTs in order to increase the knowledge on ED.~   "
31332|NCT03156946|"~     Breastfeeding has a fundamental impact on the short-, medium- and long-term health of~     children and has an important impact on women's health. Breastfeeding protects against~     gastrointestinal and respiratory illnesses and is associated with better cognitive~     development in childhood, particularly in preterm infants. Despite these potential benefits,~     preterm infants experience lower rates of breastfeeding initiation and continuation compared~     to term infants.~      The use of breastfeeding peer support initiatives, in which advice is given by experienced~     and trained peer counselors, is an effective way to promote and support breastfeeding,~     regardless of a woman's socioeconomic status. Several small studies have shown that~     breastfeeding peer support initiatives were effective for preterm infants and that this~     efficacy was increased by the co-intervention of lactation consultants.~      The purpose of this study is to develop and to evaluate the effectiveness of a breastfeeding~     support program among mother-preterm infant dyads in Europe, by evaluating the impact of the~     intervention on 1) breastfeeding rates, 2) morbidity and mortality during the~     hospitalization, 3) children's cognitive development and behavior 4) mothers' mental health,~     4) costs benefits.~      The breastfeeding support program will include peer counselors under the supervision of~     lactation consultants. Breastfeeding counselors will be voluntary mothers who have had a~     positive breastfeeding experience with at least one preterm infant. After a training course,~     they will meet the future or new mothers by face-to-face and share their experiences at least~     once a week during hospitalization and provide phone support up to 1 month after discharge~     from hospital.~      The study design will be a stepped wedge cluster trial conducted in 8 NICU in Europe (France,~     Switzerland and Belgium). Infants and mothers will be followed up from the time of~     hospitalization in the maternity and NICU up to 6 months after the discharge. The cost~     analysis will be performed in a subgroup of mother-preterm infant dyads that will be followed~     up at 24-months after their discharge~   "
31333|NCT03156933|"~     Aberrant RNA splicing and mutations in spliceosome complex in acute myeloid leukaemia (AML)~     are frequent. It have been shown that some splicing variants had a prognostic value in AML.~      AML are characterized by their propensity to relapse because of the persistence of leukaemia~     initiating cells (LICs).~      The aim of this study is to determine the splice variants on AML initiator cells and define a~     splicing pattern.~   "
31334|NCT03156920|"~     To develop a pragmatic migraine model the investigators will induce headache in healthy~     volunteers with a phosphodiesterase inhibitor (cilostazol). The participants will be~     pre-treated with sumatriptan. If the headache responds to sumatriptan, the model can be used~     to test new drug candidates.~   "
31335|NCT03156907|"~     The prevalence of analgesics opioids addiction in chronic pain patient is very difficult to~     know. Many studies indicated that the prevalence of addiction varied from 0% up to 50% in~     chronic non cancer pain patients, and from 0% up to 7.7% in cancer pain patients. Analgesics~     opioids use have increasingly been increased in chronic pain for 20 years. However, a long~     use, at least 3 months in this type of pain has not proved a large efficiency and we have~     noticed a habituation, tolerance and withdrawal when treatment was decreased or stopped. In~     current practice, patients with chronic pain, often keep their analgesics opioids despite the~     absence of pain relief and benefits in quality of life.~      Nowadays, no withdrawal strategy is the reference in chronic non-cancer pain patients with~     physical opioid dependence. The most common clinical strategy is progressive decrease of~     analgesic opioid. But this strategy is often a failure in these patients (no data are~     available in literature).~      It's necessary to make a prospective pilot study to assess benefits from this practice.~      The primary objective of this study is to assess the success rate at 6 months of opioid~     temporary rotation by High Dosage Buprenorphine (BHD) taper dose in chronic non cancer pain~     patients (CNCP) with physical withdrawal symptoms making opioid withdrawal impossible.~   "
31336|NCT03156894|"~     Among the complications of heart transplant, primary dysfunction of the graft (PDG) is the~     most feared with a net impact on early morbidity and mortality. The all-cause mortality rate~     at the international level is 10% at 30 days and 34% at one year. Mortality at 30 days is~     secondary in 66% of cases with DPG or multi-organ failure.~      The treatment of choice for the more severe PDG remains ECMO-type circulatory mechanical~     assistance or ventricular assistance. According to several studies, this could reduce early~     mortality. Early placement and short-term (<30 days) of support appear to improve survival in~     the first year after transplantation.~      The haemodynamic parameters revealing this DPG are not clearly described in the literature.~      hypothesis of this research is that:~        -  DPG risk factors in strasbourg's hospital center are comparable to other European and~          international centers.~        -  Simple hemodynamic parameters can be used to detect PDG earlier in order to set up~          assistance more quickly.~   "
31337|NCT03156881|"~     Non-alcoholic fatty liver disease is a complex disease that is growing more prominent around~     the world especially in North America because of high prevalence of overweightness and~     obesity. There are many factors that are associated with this illness and it does not seem to~     be the same in every patient. The progression of this disease can with time lead to liver~     cirrhosis and even primary liver cancer (hepatocellular carcinoma). Currently, the only~     treatment plan involves diet change and exercise.~      The goal of this research is to validate that Osteopathy can optimise patient health and to~     potentially be another option in preventing/reducing progression of this disease. This~     research is important for the future of Osteopathy to educate the public and other~     therapists/physicians the benefits this manual therapy has to offer. Previous research has~     been done and shown that Osteopathy can help patients with low back pain and type two~     diabetes, by affecting glucose and insulin levels with manipulation of the spine and~     pancreas.~      Another study compared one group of obese patients with chronic low back pain that just did~     specific exercises to another group that were given exercises as well as Osteopathic manual~     therapy (OMT). Results showed both groups had reduced pain, however only the group with~     additional OMT showed improved range of motion in the thoracic spine, and showed greater~     degree of improvement overall for these patients. This study shows how OMT can be effective~     for individuals with NAFLD for in general these patients are obese and part of their~     treatment regime is to exercise to lose weight. The researcher could not find any previous~     research on OMT contributing to weight loss, however according to the Reve Pavilion natural~     health clinic website (2015), OMT can improve underlying issues such as low back pain,~     preventing the person to exercise effectively. The researcher also hopes to gain further~     knowledge of this subject, and to show the benefits of collaborating Osteopathy and~     Allopathic medicine together to obtain optimal patient care.~   "
31338|NCT03156868|"~     Recent studies have shown that the assessment of a set of cytokines and / or circulating~     angiogenic factors (FACs) could be used to identify prognostic factors predictive of efficacy~     and / or potential mechanisms of resistance to antiangiogenic agents~   "
31339|NCT03156855|"~     The investigators aimed to~        1. compare the eradication rates and long term re-infection rates of sequential therapy for~          14 days versus bismuth quadruple therapy for 10 days in the first line and second line~          treatment~        2. assess the impact of antibiotic resistance and CYP2C19 polymorphism on the eradication~          rate of these regimens~        3. assess the impact of these eradication regimens on the antibiotic resistance and~          microbiota of the gut flora~        4. assess the impact of eradication therapy on the metabolic factors~   "
31340|NCT03156842|"~     The objective of this clinical study is to evaluate the efficacy and safety by comparing the~     fimasartan/amlodipine/rosuvastatin treatment group to the fimasartan/amlodipine treatment~     group and the fimasartan/rosuvastatin treatment group respectively at Week 8 in patients with~     essential hypertension and dyslipidemia who fail to respond to the fimasartan monotherapy.~   "
31342|NCT03156816|"~     Inflammatory processes have been identified as key mediators of ischemia/ reperfusion injury~     in ST-segment elevation myocardial infarction. They add additional damage to the myocardium~     and are associated with clinical adverse events (heart failure and cardiovascular death) and~     poor myocardial recovery. All the different anti-inflammatory approaches to reduce~     reperfusion injury have been disappointing.~      Colchicine is a well-known substance with potent anti-inflammatory properties. In a recent~     pilot study performed in 151 acute STEMI patients treated with primary percutaneous coronary~     intervention(PPCI) Deftereos et al. showed a 50% reduction of infarct size (creatine kinase~     release) with a short course treatment of colchicine in comparison to placebo.~      One mechanism to explain this effect could be the reduction of adverse left ventricular (LV)~     remodelling. LV remodelling is part of the healing process of myocardium after MI. It is~     defined as the end diastolic volume (EDV) increase in the first months after MI. Adverse LV~     remodelling is increased by inflammation and ultimately leads to heart failure.~      Our main hypothesis is that colchicine with its anti-inflammatory properties significantly~     reduces the initiation of adverse LV remodelling, together with a significant reduction of~     infarct size and microvascular obstruction in comparison to placebo in acute STEMI patients~     referred for PPCI.~      After inclusion and randomisation, patients will receive the first part of their experimental~     treatment: colchicine or placebo before PCI, then, the second part after PCI and during 5~     days. They will be followed up during their hospitalization and until one year. In order to~     evaluate LV remodelling, two cardiac magnetic resonance studies will be performed during~     their participation: one during their hospitalization and a second at 3 months. At 1 year,~     adverse events will be collected by phone.~   "
31343|NCT03156803|"~     The purpose of this study is to evaluate the effects of an evidence-based healthy eating blog~     on dietary behaviors of mothers~   "
31344|NCT03156790|"~     This is a non-controlled, single-arm, open-label clinical trial to describe the PK, PD,~     immunogenicity and safety of ASNase. All subjects enrolled will receive the IP recombinant~     ASNase (Spectrila®). Since Spectrila is already approved in the European Economic Area for~     first-line treatment of ALL patients of all age groups and showed similar efficacy and safety~     in comparison to Asparaginase medac no blinding or control groups are necessary. As~     underlying treatment protocol the BRALL 2014 treatment protocol will be used.~   "
31345|NCT03156777|"~     Evaluating the application value of a new circulating tumor cell detection method for~     advanced gastric cancer patients in prediction of the prognosis and early evaluation of the~     result of postoperation adjuvant chemotherapy.~   "
31346|NCT03156764|"~     In pediatric cardiac patients with shunt dependent pulmonary circulation, Qp/Qs ratio is a~     important parameter indicating the balance of pulmonaty and systemic circulation.~      This study will calculate Qp/Qs using variables measured using non-invasive monitors~     (cerebral oximeter and pulse oximeter). This value will be compared with Qp/Qs calculated~     using variables obtained from blood sample.~   "
31347|NCT03156751|"~     This study used a pre post intervention mixed methods quasi-experimental design with a group~     of health facilities offering antenatal care (ANC) services (primary health centers in rural~     area) as the sampling units. This study was conducted in three phases, which consisted of a~     situational analysis using qualitative methods (Phase 1), selecting an appropriate test~     through evaluating 4 candidate tests and the participatory design and implementation of an~     intervention that included onsite training, provision of supplies and medicines, quality~     control and supervision (Phase 2), and an evaluation combining review of record tools,~     interviews, time motion study and estimating incremental costs (Phase 3). The conceptual~     framework draws on multilevel assessment (MLA), policy triangle framework, Medical Research~     Council framework for designing complex interventions and the Normalization Process Model~     (NPM). Methods included document review, seventy five interviews were conducted with health~     providers, district managers, facility managers, traditional healers, pregnant women,~     community health workers, and Non-Governmental Organizations (NGO) managers in phase I and~     fourteen in phase III, non-participant observation, time-motion study, incremental cost~     analysis, and sensitivity, specificity and ease of use analysis of four candidate point-of~     care tests. Data were collected between 2012 and 2014. Qualitative data were analyzed through~     thematic analysis supported by Nvivo software. Quantitative data were analyzed through~     descriptive statistics such as frequency, mean and median supported by SPSS. Phase I~     identified barriers to implementation and uptake of syphilis testing at health provider and~     community levels. The most important barriers at provider level included fragmentation of~     services, poor communication between health workers and clients, failure to prescribe~     syphilis test, and low awareness of syphilis burden. Cost of testing, distance to laboratory~     and lack of knowledge about syphilis were identified as barriers at community level. Phase~     II: Alere DetermineTM Syphilis was the most sensitive of the four point-of-care tests~     evaluated. The components of the intervention were successfully implemented in the selected~     health facilities. Overall, phase III showed that it is feasible and acceptable to introduce~     a point of care test for syphilis in antenatal care services at primary health care level~     using the available staff. The findings suggested that an intervention that introduces point~     of care test for syphilis at antenatal care services is feasible, acceptable, and of~     comparable costs to HIV screening in pregnancy. Nonetheless, instructions and supervision~     need to be clearer to achieve optimal levels of screening and quality control, and barriers~     identified by health workers need to be overcome. The point-of care test for syphilis is~     likely to be acceptable by health workers as a routine service and incorporated as a normal~     practice in Burkina Faso context.~   "
31348|NCT03156738|"~     The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and~     immunogenicity of MT-2990 in healthy male subjects.~   "
31349|NCT03156725|"~     The objective of this study was to compare the absorption of a new iron product, iron~     enriched Aspergillus oryzae to ferrous sulfate in humans using a double stable-isotope~     technique.~   "
31350|NCT03156712|"~     Ferrous sulfate is rapidly absorbed and the bolus of iron enters blood rather quickly~     possibly leading to higher concentrations of non-transferrin bound iron which induces~     oxidative stress. The objective of this study was to determine how quickly iron enters into~     blood stream from the iron-enriched Asperigillus oryzae (AspironTM, ASP) in contrast to~     ferrous sulfate. Seventeen healthy, female subjects (18-35 y) were randomized, double blind,~     cross-over experimental design with three treatments: 10 mg iron as FeSO4 and ASP as well as~     20 mg iron as ASP.~   "
31351|NCT03156699|"~     This study will assess the incidence, effect and persistence of F-QRS (Fragmented-QRS) in~     STEMI (ST-elevation Myocardial Infarction) patients post-PCI (percutaneous coronary~     intervention). The aim is to add to the existing research field surrounding F-QRS. It is~     hypothesised that patients with F-QRS present on the surface ECG, following PCI, will have~     incurred a higher degree of damage. As a result, it is hypothesised that these patients will~     have reduced LV (left-ventricular) systolic function, increased incidence of regional wall~     motion abnormalities (RWMAs), and increased troponin levels on admission. This study will~     additionally look for correlations between F-QRS and culprit vessels. To our knowledge there~     is minimal research regarding this.~   "
31352|NCT03156686|"~     Evaluation of the efficacy, safety and and cost of home care versus conventional~     hospitalization care at 3-months in patients with worsening chronic heart failure.~   "
31353|NCT03156673|"~     Bronchial basal cells are proved to be able to regenerate lung structures to repair the~     injured lung. In COPD patients, bronchus structures are injured and cannot be repaired, which~     may result in the failure of pulmonary function rescue clinically.In our research, autologous~     bronchial basal cells will be transplanted into lung of patients suffered with COPD to treat~     the disease. Specifically, autologous bronchial basal cells will be dissected from~     brushed-off samples by bronchofiberscope. Then, they will be expanded in vitro and~     transplanted into lung to regenerate new alveoli and bronchus structures and re-establish~     pulmonary system.~   "
31354|NCT03156660|"~     The study aims to randomize 400 participants to 1 of 3 arms: a) a weight stability~     intervention prior to smoking cessation (Group 1); b) a weight loss intervention prior to~     smoking cessation (Group 2); or c) a self-guided weight management prior to cessation (Group~     3) and to determine the efficacy of the interventions on preventing weight gain at 12 month~     follow-up. All 3 conditions receive a highly efficacious behavioral smoking cessation program~     and 6 months of varenicline pharmacotherapy (ChantixTM), the most efficacious medication for~     smoking cessation.~   "
31355|NCT03156647|"~     The aim of this study is to determine whether a significant reduction in the total level of~     alpha-synuclein and significant increase in the oligomeric form of alpha-synuclein and~     therefore the ratio oligomeric:total alpha-synuclein occurs in patients with Parkinson~     disease compared to patients with drug-induced parkinsonian syndrome.~   "
31356|NCT03156634|"~     This is a randomized pilot study comparing the impact of the Patient Activated Learning~     System (PALS) on knowledge acquisition, recall, and decision making about antihypertensive~     medication compared to an established online health information system (WebMD). We will also~     compare the two systems with regard to user experience measures such as understandability and~     trust.~   "
31357|NCT03156621|"~     The primary objective of the study is to demonstrate the reduction of low-density lipoprotein~     cholesterol (LDL-C) with alirocumab subcutaneous (SC) every 2 weeks (Q2W) in comparison to~     placebo after 12 weeks of treatment.~   "
31358|NCT03156608|"~     This study will be conducted on women in labor. Fetal heart rate monitoring will be~     conducting using the Novii Fetal ECG/EMG system and comparing it to current standard of care~     external fetal heart rate and tocometry. These approaches will be compared with the respect~     to need for additional monitoring, amount of nursing intervention, cost and satisfaction of~     patients and healthcare providers.~   "
31359|NCT03156595|"~     Chimiotherapy produces neuropathies injuries to 30% to 70% cases. A third of those patients~     keeps suffering from this side effects disabilities and their quality of life is seriously~     affected.~      Hypnosis, as a non-invasive tool without physical side effects, might be used to relieve~     them.~      the purpose of this trial based on our own experience, is to demonstrate the value of using~     hypnosis and self-hypnosis in chimiotherapy- induced chronic neuropathies.~      The aim will be to sustainably improve the quality of life by expanding self-management of~     pain and motor function side effect.~   "
31360|NCT03156582|"~     This is a French multicentric retrospective study on intention-to-treat comparing results of~     LT for HCC before and after the use of the AFP score. The investigators hypothesis is a~     better respect of the Biomedicine Agency (the French national transplantation agency)~     criteria since the general application of this score in March 2013. The aim of this study is~     to determine if the tumoral characteristics at the time of LT are improved and if it modified~     the patients'outcome.~   "
31361|NCT03156569|"~     The purpose of this study was to investigate the salivary levels of inflammatory and their~     association with oral health in xerostomía patient~   "
31362|NCT03156556|"~     Anxiety and depression represent the most common mental health problems. Unfortunately, only~     a minority of people in need will seek or access traditional mental health services. Access~     to traditional psychological care is even more challenging for linguistic minorities as well~     as for people living in rural areas and for young adults - a group that has the highest rate~     of anxiety and depression but the lowest rate of consulting traditional~     services.Telepsychotherapy can facilitate access to effective psychological care as done in~     Australia where the government has been offering an evidence-based 8-week online therapy~     program called the Wellbeing Course. This online course helps people manage worry, stress,~     anxiety and depression. It has been evaluated in several clinical trials and successfully~     implemented as an Australian national treatment service. Its transdiagnostic nature, and the~     fact that the guidance of a clinician is not required for an efficient and safe~     administration and maintenance of therapeutic gains make it not only a viable option, but~     also an easily accessible fist line intervention. More recently, findings from a feasibility~     study conducted by our research laboratory have supported the efficacy of a French-Canadian~     translation among French-speaking minorities in New-Brunswick. A version of the Wellbeing~     Course for young adults has been developed called the Mood Mechanic Course. Empirical support~     has been obtained.~      This study is a feasibility open trial, the first phase of a 3-phase research program~     designed to implement a French-Canadian translation of the Mood Mechanic Course in New~     Brunswick targeting groups for which access to traditional services has been most~     problematic: youth (18 to 25 years old), people living in rural areas and linguistic~     minorities. The course is an 8-week week program based on principles of cognitive behaviour~     therapy. It includes five online lessons, do-it-yourself exercises, case stories, and~     additional resources on different topic such as sleep hygiene. Twenty young adults will be~     recruited across New Brunswick among French-Canadian minority communities. Self-report~     measures assessing anxiety and depression will be administered pre/post treatment and at a~     3-month follow-up. It is expected that the course will help overcome barriers in help seeking~     to improve the mental health of our communities.~   "
31363|NCT03156543|"~     Deep periprosthetic infection following total joint arthroplasty is a major complication.~     Although it only occurs in a small percentage of patients (~1%), it results in substantial~     morbidity and a decline in functional outcome. A two stage revision and exchange is commonly~     required in order to clear the infection and provide the best opportunity for prosthetic~     replantation. Following removal of the infected components, a minimum course of six weeks of~     parenteral antibiotics is given and resolution of the infection confirmed through the ESR,~     CRP, and repeated aspiration of the joint. In most instances a temporary spacer of~     antibiotic-loaded cement is inserted at the first stage and removed at the second operation.~      Propionibacterium Acnes is a gram-positive, non-spore-forming, anaerobic bacillus found in~     lipid-rich areas, including hair follicles, sebaceous glands, and moist areas of the shoulder~     and axilla. Because of its low virulence, infections caused by P. acnes typically have a~     low-grade, indolent course, with shoulder pain often the only presenting symptoms after~     prosthetic replacement. P. acnes is particularly challenging to both diagnose and to~     eradicate, and is a substantial source of morbidity with shoulder arthroplasty.~      JumpStart™ is a wireless, advanced microcurrent generating, dressing used for the management~     of surgical incision sites. Microcell batteries made of silver and zinc, generate an~     electrical current when activated by conductive fluids, such as saline, hydrogel or wound~     exudate. These microcells create low voltage electrical fields to stimulate the surrounding~     area and to provide antimicrobial protection to assist with wound healing. JumpStart has~     demonstrated superior broad spectrum bactericidal activity of a wound dressing against~     antibiotic-resistant strains of wound isolates within 24 hours.~      The use of JumpStart as a prophylactic preoperative dressing to alter the skin flora and~     thereby decrease the risk of prosthetic infection has not been investigated to-date. Given~     the morbidity of a prosthetic infection, this would be a remarkably valuable intervention for~     any joint replacement procedure.~   "
31364|NCT03156530|"~     By using a static stabilometry platform, the investigators believe the possible verification~     of the efficiency of auricular acupuncture points that correlates with regions of our body~     that may interfere with static equilibrium.~      The present work aims to analyze the effect of the stimulation of atrial points of the lower~     limbs on the equilibrium response evaluated by static stabilometry.~   "
31389|NCT03156192|"~     The purpose of this study is to investigate how family caregivers of ICU patients perceive~     their psycho-social needs and quality of life, how they use music in their everyday life and~     perceive music as beneficial to themselves. Participants are adult family members of~     critically ill patients in ICU. After obtaining the informed consent form, a questionnaire~     will be distributed to each participant.~   "
31365|NCT03156517|"~     Action tremor of the arms can be an invalidizing symptom of diseases such as Essential~     Tremor, Dystonic Tremor, Parkinson's disease and Multiple Sclerosis. In this study we compare~     the efficacy and safety of two different brain targets for deep brain stimulation (DBS) that~     both are known to reduce action tremor of the arms. These two targets are called the VIM~     nucleus of the thalamus (VIM) and the posterior subthalamic area (PSA), which includes the~     Zona Incerta. Both targets can be reached by one lead (wirh four electrode contact).~      Patients that are found eligible for DBS because of severe action tremor of the arms are~     invited to participate. After randomization, half of them are stimulated first in the VIM for~     3 months and then in the PSA for 3 months, and the other half first in the PSA and then VIM~     for 3 months each. Tremor severity is scored on a clinical quantitative scale at baseline and~     at the end of each of these two 3-month periods, and eventual side-effects are registered.~     The best target is then selected and after another 6 months scoring is repeated. We intend to~     provide robust data about whether one of the two targets is superior to the other both~     regarding ability to reduce tremor efficiently and to avoid or minimize side-effects, or if~     there is no significant difference between the two targets. We also carefully check the exact~     position of the active electrode contact in the brain and compare this with efficacy and~     safety evaluations.~   "
31366|NCT03156504|"~     The purpose of this research study is to find out if the medication known as ketamine can~     help the symptoms of depression. This drug is approved by the Food and Drug Administration~     (FDA) but the investigators will use it for a non-FDA approved reason (depression).~   "
31367|NCT03156491|"~     Background of the study:~      The etiology of recurrent miscarriage (RM, defined as three or more consecutive miscarriages~     without any proven maternal or fetal cause), remains undiagnosed in more than 50% of cases.~     In these cases it is generally considered that a disturbance in the normal mother-embryo~     interactions is a causal factor. This disturbance may be based on a dysregulation of embryo~     invasiveness and/or decidual acceptance (e.g. altered decidualization; endometrial changes in~     preparation for the acceptance of a putative pregnancy). Moreover, dysfunctional maternal~     immune regulatory natural killer (NK) cells, implicated in tolerance induction and~     trophoblast invasion,may also underlie the occurrence of RM. The Selection Failure hypothesis~     for RM suggests that super-receptive endometrium (possibly due to increased embryo~     invasiveness and/or decidual acceptance and/or dysregulated immune cell function) may allow~     'poor quality' embryos to implant and present as a clinical pregnancy before miscarrying.~     Fundamental knowledge on mechanisms of embryo implantation, decidual function and maternal~     immune reactivity in successful pregnancies has accumulated over the past 5 years. This study~     aims to investigate whether dysregulation of (one of) these mechanisms may underlie RM.~      Objective of the study:~      To test The Selection Failure hypothesis by assessing A) the degree of embryo invasiveness~     and decidual acceptance (the quality of decidualization, endometrium-embryo communication and~     endometrial stromal cell (ESC) migration) and B) the angiogenic capacity of decidual NK (dNK)~     cells, in order to elucidate the pattern of the mother-embryo equilibrium in women with RM.~   "
31368|NCT03156478|"~     The aim of the Stop Diabetes - Knowledge based solutions (StopDia) consortium project~     (University of Eastern Finland, National Institute for Health and Welfare, and Technical~     Research Centre of Finland) is to develop and test approaches to identify individuals at~     increased risk of type 2 diabetes and to empower them in adopting and maintaining a healthy~     lifestyle by combining individual and environment level strategies into a dual-process~     approach targeting deliberative and automatic processes of behavior. We also aim to identify~     barriers and facilitators of adopting a healthy lifestyle in the society, create a model for~     the prevention of type 2 diabetes by joint actions of health care, third sector, and other~     societal actors, and develop methods to monitor the cost-effectiveness of these actions. We~     will carry out a 1-year randomized controlled trial on the effects of among 10 000~     individuals aged 18-70 years at increased risk of type 2 diabetes living in Finland. The~     participants will be randomized into the control group, the digital lifestyle intervention~     group, or the combined digital and face-to-face lifestyle intervention group. The aim of the~     interventions is to enhance diet quality, increase physical activity, decrease body weight,~     and improve glucose tolerance in individuals at increased risk of type 2 diabetes.~   "
31369|NCT03156465|"~     The purpose of this feasibility study is to evaluate whether implantation of one Nucleus L24~     electrode array and one FDA approved standard-length device in the contralateral ear can~     provide useful binaural hearing in pediatric subjects who have bilateral severe to profound~     hearing loss, meeting the criteria for cochlear implantation. Unlike a conventional cochlear~     implant, the Nucleus L24 is expected to preserve the regions of the cochlear partition that~     are apical to the electrode, thus leaving them available for possible future advances in the~     field of otolaryngology and hearing devices, such as mammalian hair cell regeneration~     techniques or improved implantable hearing devices. Whether or not this group of children~     will be able to take advantage of future hair cell regeneration strategies is yet to be~     determined and will have to wait for future development. At this time there are no accurate~     imaging strategies available to identify preservation of the scala media. Ultra thin micro CT~     scanning is in development, however the level of radiation delivery to the subject is too~     great to be considered for clinical use. When imaging strategies become available to~     determine cellular structure of the inner ear, they will be applied to this group of~     subjects. The Nucleus L24 array stimulates the basal turn of the cochlea, in an attempt to~     preserve the middle and apical regions of the scala media.~   "
31388|NCT03156205|"~     (Background) Adults in intensive care units (ICU), especially elderly patients often suffer~     from a lack of sleep or frequent sleep disruptions due to physical, emotional stress such as~     pain, inflammation, and anxiety. Delirium, acute cognitive dysfunction, which result from~     sleep deprivation often leads to prolonged ICU stay and increase medical costs.~     Pharmacological and non-pharmacological interventions have been tried to improve the duration~     and quality of sleep and to maintain diurnal cycle. (Purpose) The aim of this study is to~     assess the efficacy of patient-driven interactive music intervention on sleep promotion in~     critically ill elderly adults. Delirium and urine/blood melatonin level will be assessed,~     too. In this study, randomized controlled trial for 50 elderly ICU patients who aged over 65~     years in each group will be proceeded.~   "
31370|NCT03156452|"~     This is a study of two treatment pathways [Standard steroid treatment versus combined steroid~     and Mycophenolate (MMF)] for subjects with newly diagnosed Immune Thrombocytopenia (ITP). ITP~     is an illness that causes bruising and bleeding due to a low platelet count (blood cells~     essential for normal clotting). Patients are first given high dose steroids but most suffer~     side effects (e.g. difficulty sleeping, weight gain, moods swings, high blood pressure and~     diabetes). In addition, the majority of patients become ill again when the steroids are~     stopped - only about 20% stay well long term. ITP is relatively rare, non-cancerous in nature~     and the rare impact on survival of ITP have prevented it from being a priority for research~     funding, with first line treatment being unsatisfactory and unchallenged for decades. This~     underestimates the profound adverse impact an ITP diagnosis and its treatment has on~     individual patients, many of whom are young.~      MMF is often used as the next stage treatment for ITP and it works well. However, it can take~     up to 2 months to work during which patients continue to be at risk of bleeding, bruising,~     fatigue and usually need more steroids which they find intolerable. They are required to come~     to hospital for weekly blood tests and for many this impacts on work. We want to find out~     whether it would benefit more patients if everyone takes MMF at diagnosis instead of current~     practice (waiting for the illness to come back). We plan to test this by comparing the~     current way we treat patients to a new way with patients given MMF right at the start of~     their treatment. 120 patients from 20 different hospitals will be asked to take part and half~     will be randomly chosen for the new pathway.~   "
31371|NCT03156439|"~     This study investigates the safety, tolerability, and pharmacokinetics of BIS-001 ER in~     healthy volunteers. Subjects will be dosed twice daily, with a dose escalation occurring~     every 2-3 days until a maximum dose of 5mg per day is reached.~   "
31372|NCT03156426|"~     Acute kidney injury (AKI) is a common and under-diagnosed problem in patients with liver~     cirrhosis, and is associated with significant illness and preventable death. Blood (serum)~     creatinine is the current test for kidney function, but it is an insensitive and non-specific~     marker in cirrhosis. The investigators hypothesise that blood (plasma) levels of kidney~     injury molecule-1 (KIM-1) will detect AKI earlier and predict the risk of worsening AKI in~     cirrhosis, thus identifying patients in need of prompt and effective treatment and improving~     patient outcomes. The investigators will collect blood and urine samples from cirrhosis~     patients admitted into hospital and study the relationship between plasma KIM-1, other~     diagnostic 'biomarker' tests that have recently been proposed, and patient outcomes.~   "
31373|NCT03156413|"~     This investigation is designed to evaluate the performance as well as the patients overall~     acceptance of the mask.~   "
31374|NCT03156400|"~     This study will compare examine autonomic and cardiovascular responses to peak exercise~     testing in Parkinson's disease patients in varying stages of the disease, and healthy,~     age-matched participants. Participants will be asked to complete a peak exercise test on a~     motorized treadmill. Heart rate, blood pressure, norepinephrine, and other markers for~     cardiovascular function will be assessed at rest, during exercise, and post-exercise. The~     hypothesis to be tested is that Parkinson's disease patients will exhibit a decreased~     autonomic and cardiovascular response to exercise when compared to patients' healthy~     age-matched counterparts. The investigators secondary hypothesis is that Parkinson's disease~     patients in more advanced stages will exhibit a greater decrease in response when compared to~     these patients' Stage 1 counterparts, or healthy age-matched counterparts.~   "
31375|NCT03156387|"~     The aim of present study was to compare the keratinized gingival tissue measurements, degree~     of subjective complaints, and functional complications of using an 980 nm diode laser versus~     a scalpel for frenectomies. Thirty-six patients requiring frenectomies, between 18 and 51~     years old, were randomly assigned to either scalpel or diode laser treatments. The soft~     tissue measurements, including the keratinized gingiva width (KGW), attached gingiva~     width(AGW), and attached gingiva thickness (AGT), were recorded before surgery, immediately~     after, one week later, and one, three, and six months after surgery. In addition, the~     functional complications and the morbidity (level of pain, swelling, and redness) were~     evaluated during the first postoperative week using a visual analog scale (VAS). The VAS~     scores indicated that the patients treated with a diode laser had less discomfort and~     functional complications compare with scalpel surgery.~   "
31376|NCT03156374|"~     This proof of concept study is designed to determine the practicality of using home ovulation~     tests to enable optimum timing for transfer of frozen embryos in a natural menstrual cycle in~     comparison to the standard ultrasound and serum monitoring currently conducted by many IVF~     clinics. The study will evaluate the ability of home ovulation tests to accurately time~     Frozen Embryo Transfer (FET) directly compared to standard clinical procedures. In addition,~     women's likability and stress associated with timing a FET cycle using both methods will be~     evaluated by collecting qualitative data using standardised questionnaires.~      The impact of psychological stress on FET outcome such as implantation rates and viability at~     first scan will be considered in order to gather information for the design of a larger~     clinical study and basic financial data will also be collected, in order to pilot a~     cost-effectiveness evaluation of the two FET timing methods.~   "
31377|NCT03156361|"~     Single Center, Double Blind, Active Comparator Controlled 2-Way Crossover Multiple Dose~     Safety, Tolerability and Efficacy Study~   "
31378|NCT03156348|"~     Adverse drug events (ADE) are one of the major problems affecting quality of care and~     achievement of therapeutic goals in older adults (OA), increasing re-admissions, hospital~     stays, resource use, and problems on patient safety. The present study aim is to determine~     the impact of the clinical pharmacist interventions on the prevention of ADE in OA at 3~     months post-discharge compared to usual care.~      A randomized clinical trial of two parallel groups 1: 1 (control and intervention) plus a~     historical control group will be carried out at the Internal Medicine Service (IMS) of the~     teaching Hospital at the University of Chile. The sample will be of 611 patients (242 per~     each parallel group and 127 of the historical control group) of 60 years or older, admitted~     to the IMS for acute pathology or decompensation of chronic pathology, with survival over 6~     months, who is under pharmacological therapy and have a caretaker or responsible contact~     person at discharge.~      The historical control group will receive usual care and the parallel control group will also~     receive training on pharmacogeriatrics. The intervention group will receive the care of a~     clinical pharmacist during hospitalization, at discharge and post-discharge, through a home~     visit at 30 days post-discharge and a telephone call at 60 days post discharge.~   "
31379|NCT03156335|"~     The proposed study is to evaluate the safety and initial efficacy of MRgFUS for patients with~     treatment-refractory OCD. This study is designed as a prospective, single arm, nonrandomized~     study. Assessments will be made before and after MRgFUS for adverse events related to~     treatment, for clinical symptom relief, and quality of life (QoL). The target in the brain~     chosen for ablation will be the anterior limb of the internal capsule (ALIC) (i.e~     'capsulotomy'). Safety will be assessed prospectively in radiologic and clinical terms.~     Post-procedural imaging will be evaluated for evidence of swelling, hemorrhage, and the~     evolution of the lesion in the anterior limb of the internal capsule. Patients will be~     clinically followed up at Day 1, Month 1, Month 3, Month 6 and Month 12 post-procedure. At~     every follow-up visit, patients will be evaluated for general health, neurological changes,~     as well as for device/procedure related adverse events. Imaging will also be performed with~     positron emission tomography (PET) and MRI, as per the Month 3 and Month 12 post-procedure.~     Feasibility will be evaluated by determining the rate of patient accrual, the tolerability of~     the procedure for patients, and the technical ability of heating the ALIC to lesional~     temperatures.~   "
31380|NCT03156322|"~     The aim of this study is to compare the effect of different epidural initiation volumes on~     postoperative pain scores, local anesthetic requirements, and motor block in patients who~     undergo patient controlled epidural analgesia for postoperative pain after cesarean section.~   "
31381|NCT03156296|"~     Pediatric laparoscopy has been first described in 1923 by Kelling but its use has increased~     since last decade. A laparoscopic approach offers several advantages over an open procedures;~     potentially reduces the surgical stress and fluid shifts that may accompany it; in addition~     there is less need for postoperative analgesia, reduction of postoperative respiratory and~     wound complications; shortens postoperative convalescence, including an intensive care unit~     stay; rapid return to normal diet and decreased overall hospital stay.~      Despite the minimally invasive nature, pain can be moderate to severe in the immediate~     postoperative period.~      Inadequate control of post-operative pain leads to several unwanted adverse events ranging~     from patients' discomfort and prolonged immobilization to thromboembolic phenomenon and~     pulmonary complications.~      Analgesic multimodalities were recommended to relieve the post-operative pain. Opioids~     although provide satisfactory analgesia, they are associated with unwanted side-effects.~      Transversus abdominis plane (TAP) block is a type of peripheral nerve block that involves~     innervations of the anterolateral abdominal wall. It provides adequate post-operative pain~     relieve following various abdominal surgeries.~      With the aid of ultrasound or anatomical landmark guidance, local anesthetic (LA) is injected~     into the transversus abdominis fascial plane, where the nerves from T6 to L1 are located.~      Ultrasound TAP block is also accompanied by a good pain relief and reduced intraoperative and~     postoperative opioids requirements after laparoscopic surgery. In this case a bilateral TAP~     block is necessary because the abdominal skin incisions for the ports of laparoscopic~     procedure are performed on both sides.~      Unfortunately, TAP block duration is limited to the effect of administered LA. Recently,~     adjuvant medications were added to LA to prolong the effect of TAP block. Dexmedetomidine is~     a selective alpha 2 (α2) adrenergic agonist with both analgesic and sedative properties. Its~     use with bupivacaine either epidurally or intrathecally is associated with prolongation of~     the LA effect.~   "
31382|NCT03156283|"~     Obstructive sleep apnea (OSA) is a major public health concern n the United States. Positive~     airway pressure (PAP) therapy is the treatment-of-choice and gold standard for individuals~     with moderate-to-severe OSA. Regular and sustained PAP use can reduce risk for subsequent~     disease and improve quality of life. Nevertheless, PAP adherence rates are low. Most PAP~     adherence programs do not address the self-management skills and strategies that promote~     adherence and are often too costly and complex to integrate into overburdened clinical~     environments. Furthermore, they do not leverage opportunities to change lifestyle behaviors~     that occur across the 24h spectrum (i.e., sleep hygiene, sedentary behavior, physical~     activity), which have promise to improve OSA symptoms and PAP adherence. The investigators~     have previously developed and successfully tested BeWell24, a multicomponent smartphone app~     that uses evidence-based behavior change strategies to improve sleep, sedentary, and physical~     activity behaviors. The investigators will enhance this app to create SleepWell24.~     Enhancements will include: (1) specific behavior change strategies from the evidence-based~     Sleep Apnea Self-Management Program to promote PAP adherence; (2) an interface for exchange~     of patient data to facilitate patient-provider communication on treatment progress; and (3)~     real-time feedback via wireless integration with a consumer-based PAP machine and wearable~     sensor. All aspects of this work will be embedded within the Mayo Clinic Arizona Center for~     Sleep Medicine. The investigators will test the effects of SleepWell24 in newly prescribed~     PAP users and gather data on the feasibility and acceptability of using SleepWell24 compared~     to a usual care control group. The investigators will conduct a pilot randomized controlled~     trial with participants randomly assigned to (1) SleepWell24; or (2) usual care for 60 days~     post-PAP prescription. The investigators will track recruitment/retention rates, app usage~     statistics, and measures of treatment satisfaction. The investigators will objectively~     measure PAP adherence to test whether the SleepWell24 group will have more hours/night of PAP~     usage compared to the usual care group. In an exploratory fashion, the investigators will~     also examine the effect of SleepWell24 on selected treatment outcomes (weight, daytime~     sleepiness, cognitive impairment, and health-related quality of life) and evaluate social~     cognitive and lifestyle behavior mediators of SleepWell24 on PAP adherence.~   "
31383|NCT03156270|"~     This study evaluates subjective and objective measures of treatment outcome after using the~     Aerin Medical Vivaer™ Stylus to treat nasal obstruction~   "
31384|NCT03156257|"~     By studying the affect of the space environment on vascular cell types, our goal is to~     elucidate the mechanism of vascular cell damage in the space environment by exposing vascular~     cells to space flight. In this pilot study, The study team propose to assess changes in~     transcriptomics of vascular cell types in space compared to those in a ground based study.~   "
31385|NCT03156244|"~     In this pilot study, a total of 80 patients with prostate or bladder cancer (40 black, 40~     white) will complete 3 patient-reported outcome (PRO) surveys: baseline (pre-treatment),~     during treatment, and after treatment. The overall goal of this study is to assess whether~     collecting patient-reported data is feasible as part of clinical care of cancer patients, and~     whether these data are useful for clinicians and patients. Among these 80 patients, those who~     agree will also undergo a semi-structured interview to assess value of HRQOL assessment at~     the end of the study. Of specific interest is an evaluation of whether feasibility and~     perceived value differ between black and white participants.~   "
31386|NCT03156231|"~     Randomized, placebo controlled trial evaluating efficacy of acetazolamide in preventing~     altitude related adverse health effects (ARAHE) in lowlanders with chronic obstructive lung~     disease travelling from 760 m to 3200 m.~   "
31387|NCT03156218|"~     The PaO2/FiO2 ratio is frequently used to determine the severity of lung injury in~     mechanically ventilated patients. However, several mathematical models have shown that~     PaO2/FiO2 ratio depends on FiO2. The relationship is complex and depends on numerous~     physiological variables, including shunt fraction, and arterio-venous oxygen difference. The~     nonlinear relation between PaO2/FiO2 and FiO2 underlines the limitations describing the~     intensity of hypoxemia using PaO2/FiO2 and is thus of major importance for the clinician.~     Surprisingly, this relationship has only been assessed mathematically. Obviously, the~     accuracy of the mathematical relationship depends on the input variables used.~      The current study is designed to assess the PaO2/FiO2 vs FiO2 relation in mechanically~     ventilated patients without ARDS (n =10) and with mild or moderate ARDS (n =10). In order to~     explain the dependency of the PaO2/FiO2 on FiO2, shunt fraction and alveolar - arterial~     oxygen difference ((A-a)DO2) will be determined in these patients.~   "
31391|NCT03156166|"~     Ambu AuraGain, I-gel, Air-Q intubating laryngeal airway are the most commonly used~     supraglottic airway. In children, they can be used as intubation conduits. However, there has~     been no guideline for optimal insertion depth of endotracheal tube through those supraglottic~     airway. In this study, the investigators will measure the distance from grille of those~     supraglottic airways to glottis using fiberoptic bronchoscope in children undergoing~     anesthesia. This distance allows us to predict an appropriate depth of endotracheal tube when~     it should be inserted through each supraglottic airway.~   "
31392|NCT03156153|"~     We are going to carry out a randomized double-blind placebo-controlled trial to study the~     efficiency and mechanism of bumetanide on the treatment of children with Autism Spectrum~     Disorder.~   "
31393|NCT03156140|"~     Evaluate the performance of 4 pulse oximeters in 10 healthy adult volunteers with three~     motions compared to non-motion control at three arterial oxygen saturation target plateaus.~   "
31394|NCT03156127|"~     The purpose of this study is to evaluate the Pharmacokinetics and Safety / Tolerability of~     BR-UPS (Ulipristal acetate) 5 mg tablet with Inisia (Ulipristal acetate) 5 mg tablet in~     healthy female volunteers~   "
31395|NCT03156114|"~     This study tests the new medicine BI 754111 alone or in combination with BI 754091 in~     patients with advanced cancer. The study tests different doses to find the best dose for~     continuous treatment~   "
31396|NCT03156101|"~     This is a single arm, open-label, uni-center, phase I/II study to determine the safety and~     efficacy of an experimental therapy called BinD19 cells in patients with B-cell acute~     lymphoblastic leukemia or lymphoma, who are chemo-refractory, relapsed after allogeneic SCT,~     or are otherwise ineligible for allogeneic stem cell transplant.~   "
31397|NCT03156088|"~     Overactive bladder syndrome (OAB) is a prevalent disorder that affects about 10% of the adult~     population and > 40% of elderly. It is defined by the presence of urgency, with or without~     urge incontinence, in the absence of infection or other pathology. In 1997 through 1999,~     sacral nerve stimulation SNS (InterStim, Medtronic Inc., Minneapolis, Minnesota) was approved~     by the U.S. Food and Drug Administration (FDA) for treating urge urinary incontinence,~     urinary urgency, and frequency. Despite the large numbers of SNS performed, the only~     objective clinical evaluation of OAB is urodynamic detrusor instability (UDI) with some~     evidence suggesting a correlation with outcomes after sacral neuromodulation.~      Interestingly, the mechanism of action of SNS is not fully understood. Theories include~     direct activation of efferent fibers to the striated urethral sphincter causing reflex~     relaxation of the detrusor or potential activation of afferent fibers selectively which can~     lead to inhibition at spinal and supraspinal levels. Somatic sacral afferent inflow~     activation at sacral level affects the storage and emptying reflexes in the bladder and~     central nervous system, explaining the beneficial effects of neuromodulation on both storage~     and emptying functions of the bladder. Malaguti and his colleagues detected somatosensory~     evoked potentials during sacral neuromodulation, revealing that sacral neuromodulation works~     by both sacral afferent activity and somatosensory cortex activation. As sacral~     neuromodulation is clinically proven for both storage and emptying bladder dysfunctions, it~     is difficult to isolate its action to either sacral afferent or efferent circuits in the~     micturition reflex pathway. In our study, we are going to study sacral neuromodulation~     outcome predictors from the clinical and urodynamic perspectives in order to help identifying~     the right candidates for sacral neuromodulation procedure.~   "
31398|NCT03156075|"~     The aim of the study is to investigate whether a simple intervention improves the physical~     functioning and reduce mortality after surgery for elderly hip fracture patients in a period~     of one year follow up. We hypothesized that the postoperative intervention program decreases~     the mortality in one year and improves mobility.~      This study is a randomized controlled trial designed as a prospective intervention and a~     historical control group from the previous three months admitted operated hip fracture~     patients from another study and with bone mineral density and measurement of weight and~     height done. The study will include patients of both sexes, 50 years and older, after their~     approval to participate and applying exclusion criteria. A baseline assessment will be done~     for the included hip fracture patients, who will be admitted to Trauma Unit of Assiut~     University Hospitals and will be surgically treated for a period of 1 year. The exclusion~     criteria include patients with major accidents, polytrauma, pathological fractures and~     bilateral hip fractures. Also patients with thyroid malfunctions, renal diseases, cardiac~     diseases, long term immobilization, liver diseases and musculoskeletal disorders. Two~     well-trained nurses will carry out the personal interviews in the Trauma Unit ward with each~     patient and/or patients 'relatives using a structured questionnaire. Data collection will be~     done after providing informed consent.~      Bone mineral density, weight and height for every patient will be done. The follow up phone~     calls will be done for every patient at 3 months, 6 months and one year postoperative.~      Intervention group:~      Patients in the intervention Group will be provided with postoperative health education~     intervention program, which includes nutrition education for improving general and bone~     health and physical exercise training for the patient and his relative before discharge.~      This group will receive the usual care prior to the start of intervention and participating~     in the study.~      The phone calls will include questions about: if the patient is alive or not. If not,~     subsequent detailed questions about causes and timing of death will be filled in.~      If the patient is alive, subsequent questions about nutrition, commodities and physical~     activity will be filled in. Assessment of physical activity will be done by the Western~     Ontario And McMaster Universities Osteoarthritis Index (WOMAC).~   "
31399|NCT03156062|"~     Psoriasis is a multisystem disease predominately manifested as chronic inflammation of the~     skin and characterized by scaly, erythematous patches, papules and plaques, which are often~     pruritic. As chronic disease, psoriasis waxes and wanes throughout patient life time. The~     disease course is modified with initiation and cessation of treatment, and spontaneous~     remission is rare. Clinically lesions can be distributed in any part of the body, this leads~     to impaired consequences on the perception of body image, social relations and in general on~     quality of life.~   "
31400|NCT03156049|"~     Postdural puncture headache (PDPH) is a common complication associated with neuraxial~     anesthesia and diagnostic lumbar puncture (LP). PDPH is defined as a bilateral headache that~     develops within 7 days and disappears within 14 days after the dural puncture with a distinct~     postural quality. PDPH causes significant short-term disability, prevents ambulation and care~     of the newborn (in obstetrics), and results in a prolonged hospital stay.~   "
31401|NCT03156036|"~     This is a prospective biomarker-stratified, randomised phase II study of preoperative CRT~     with temozolomide plus capecitabine in patients with locally advanced rectal cancer.~      The primary endpoint is pathologic complete response rates defined as total regression of the~     primary tumor.~      For each cohort of MGMT hypermethylated versus MGMT unmethylated, patients will be randomised~     (ratio 1:1 for each arm) into preoperative CRT with capecitabine or preoperative CRT with~     temozolomide plus capecitabine arms. According to the prior phase I results, MGMT~     hypermethylated arm is estimated as 70% of total patients and the target pathologic complete~     response rate was assumed as 35% in this population when treated with preoperative CRT with~     temozolomide and capecitabine (15% in the standard treatment arm or those with unmethylated~     MGMT). Investigator would like to demonstrate the superiority in terms of pathologic complete~     responses when treated with preoperative CRT with temozolomide plus capecitabine in patients~     with locally advanced rectal cancer, and to validate the predictive role of MGMT status~   "
31402|NCT03156023|"~     A study to evaluate the safety and tolerability of AMG 570 following multiple dose~     administration in subjects with rheumatoid arthritis (RA).~      A study to characterize the pharmacokinetic profile of AMG 570 following multiple dose~     administration in subjects with RA.~      Hypothesis: Multiple dose administration of AMG 570 will have acceptable safety and~     tolerability profiles in RA subjects within the proposed dose range.~   "
31403|NCT03156010|"~     The purpose of the proposed study is to compare the sensitivity and specificity of three~     oculomotor test devices in normal subjects versus subjects with history of TBI. The study is~     designed as a prospective research project in which a group of 120 normal controls without a~     history of TBI will be compared to another group of 120 participants (total of 240) who have~     a confirmed history of TBI. Each participant will complete the TBI assessment protocol for~     each of three separate devices (Neuro Kinetics, SyncThink, and Oculogica). The order of the~     devices will be counter-balanced across participants. Participants will also be screened for~     vestibular migraine and visual vertigo, which are two conditions that influence~     oculo-vestibular perception in normal and TBI patients and might influence the results from~     the three oculomotor devices. Data from each device will be utilized to perform AUC analyses~     to determine the respective sensitivity and specificity for each.~   "
31404|NCT03155997|"~     The purpose of this study is to evaluate the safety and efficacy of the study drug~     abemaciclib in participants with high risk, node positive, early stage, hormone receptor~     positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer.~   "
31405|NCT03155984|"~     Hepatitis B virus (HBV) reactivation is common during anti-CD20 containing chemotherapy, even~     in HBsAg-negative patients with only prior HBV exposure. The optimal timing of commencing~     antiviral therapy and the interval of clinical monitoring is uncertain. 25% of the Hong Kong~     population has prior HBV exposure. The investigators plan monitor this cohort of patients and~     determine (1) the optimal time point for starting antiviral therapy based on the progression~     of HBV reactivation, and (2) the optimal interval of clinical monitoring.~   "
31406|NCT03155971|"~     This study evaluates the Efficacy and Safety of Paclitaxel-Coated Balloon Catheter in~     Patients With Diffuse Long De Novo Lesions of Main Coronary Arteries.~   "
31407|NCT03155958|"~     Alopecia areata (AA) is a common, idiopathic and sometimes recurrent non-scarring type of~     hair loss.~      Several etiological factors, including psychological, trauma-related, genetic and autoimmune~     factors have been considered as possible etiological factors . A T cell-mediated autoimmune~     mechanism in genetically vulnerable individuals is the most acceptable etiology.~      Alopecia areata presents clinically with well demarcated patches of non cicatricial hair loss~     in any hair bearing area with no remarkable gender preference.~      Although AA may occur at any age, incidence is high among younger age groups. In fact, it is~     the most common form of alopecia seen in children. Various clinical patterns of alopecia have~     been described as patchy, diffuse, reticulate, ophiasis and ophiasis inversus. Depending on~     the extent of hair loss, it can be classified into alopecia subtotalis, alopecia totalis~     (complete loss of scalp hair), and alopecia universalis (complete loss of body hair).~      National Alopecia Areata Foundation has devised Severity of Alopecia Tool Score (SALT~     score) as a measure of disease severity. Scalp is divided into 4 areas, namely, Vertex-40% of~     scalp surface area; right and left profiles-18% each and posterior scalp aspect-24%. SALT~     score is the sum of percentage of hair loss in the above mentioned areas.~   "
31408|NCT03155945|"~     The purpose of this randomized, open-label, parallel, phase 2a study is to determine the~     tolerability, pharmacokinetics, and efficacy of APD371 in subjects with Crohn's disease~     experiencing abdominal pain.~   "
31409|NCT03155932|"~     The purpose of this open-label, pilot, proof of concept study is to evaluate the safety,~     tolerability, and efficacy of oral etrasimod (APD334) in patients with primary biliary~     cholangitis (PBC).~   "
31410|NCT03155919|"~     Taurine is a nitrogenous compound, naturally present in heart, leukocytes, retina, central~     nervous system, especially in muscles. It has several beneficial physiological effects like~     antioxidant action, and could increase muscle force contraction and insulin sensibility.~     Triathlon is a sport of medium to high intensity, that can causes an increase in the rate of~     oxygen consumption during intense exercise and consequently increases free radicals~     production and oxidative stress, which may compromise an athlete's performance. Due to the~     weekly intense training, triathletes need nutritional care ranging from calories and~     nutrients adequacy to the use of specific nutrients that can help to maintain health. Thus,~     it is believed that the use of taurine associated with chocolate milk after exercise can~     promote general metabolic insulin action in order to favor carbohydrates metabolism~     regulation, assist muscle recover and prevent oxidative damage and thus promote triathletes~     performance and muscle mass gain. Thus, the aim of this project is to evaluate the effects of~     taurine and chocolate milk supplementation in body composition, athletic performance and~     oxidative stress in triathletes.~   "
31411|NCT03155906|"~     INTRO-HCV is a multicentre randomised controlled clinical trial that will compare the~     efficacy of integrated treatment of chronic hepatitis C virus infection (HCV) within~     medically assisted rehabilitation (MAR) clinics providing opioid substitution therapy (OST)~     compared to standard treatment. The trial will recruit approximately 250 HCV infected in~     Bergen and Stavanger and about 1000 in a linked observational study.~      Intervention: Integrating diagnostic and treatment follow-up for HCV treatment into MAR~     outpatient clinics in Bergen and Stavanger including testing for HCV, counselling and~     treatment evaluation and treatment delivery.~      Primary objectives: Compare the effect of integrated HCV treatment assessed with sustained~     virological response at 12 weeks between the MAR outpatient clinics in Bergen and Stavanger~     (intervention arm) with standard treatment provided after referral to infectious disease~     clinics among patients who receive OST having HCV Secondary objectives: Compare treatment~     adherence between the intervention and control arms, and assess changes in quality of life,~     fatigue and psychological well-being before and after HCV treatment, as well as changes in~     drug use, infection related risk behavior, and risk of reinfection among those with sustained~     virological response.~      Main endpoint: Sustained virological response of HCV at 12 weeks (± 10 days) Study~     population: The target group will be patients receiving care with MAR from involved~     outpatient clinics in Bergen, Sandnes and Stavanger who are chronically infected with HCV and~     eligible for treatment according to national guidelines.~      Study duration: Participants will be included and followed up at least annually for the total~     study duration between 2017 and 2021.~      Expected outcome: This study will inform on the relative advantages and disadvantages of an~     integrated treatment program for HCV into MAR compared to standard care aiming to increase~     access to treatment and improved treatment adherence. If the integrated treatment structure~     is found to be safe and efficacious, it can be considered for further scale-up.~   "
31412|NCT03155893|"~     The main purpose of this study is to assess the effect of a single supratherapeutic dose of~     AL-335 administered on top of multiple doses of odalasvir (ODV) and simeprevir (SMV) versus~     placebo on QT/QT interval corrected for heart rate (QTc) interval changes, using~     intersection-union test (IUT) analysis (Panel 1); to assess the effect of ODV on QT/QTc and~     PR interval changes after multiple supratherapeutic doses of ODV using an exposure-response~     (ER) approach (Panel 2); and to assess the effect of multiple supratherapeutic doses of ODV~     on echocardiographic left ventricular ejection fraction (LVEF) (Panel 2) in healthy~     participants.~   "
31413|NCT03155880|"~     The investigators will assess the heterogeneity of obese individuals in the United States to~     help researchers, clinicians and policymakers to establish goals for obesity treatment and~     identify whether differing interventions may be needed.~   "
31415|NCT03155854|"~     Research is instrumental for improving medical care and the patient experience. Finding new~     surgical techniques can create better outcomes and minimize recovery time and complications~     for patients. Some patients undergoing trigger finger surgery with a pre-existing Dupuytren's~     cord may develop a thickened surgical scar after surgery, which can cause discomfort,~     difficulty with moving or using, and other complications in the affected finger(s) or hand.~     The investigator is investigating a surgical technique to minimize these potential~     complications and scarring after surgery.~      Subjects are being asked to take part in this research study because they have been diagnosed~     with trigger finger and pretendinous Dupuytren's cord and have decided to undergo surgery~     rather than try medical treatment.~   "
31416|NCT03155841|"~     The investigators propose to deliver and test a life skills intervention targeting the key~     domains that fuel HIV disparities among adolescent (ages 13-18) same-sex attracted men in the~     United States. This RCT will yield important information regarding the delivery of a~     developmentally-appropriate HIV prevention program that reaches racial/ethnic and~     socioeconomically diverse sample of adolescent men across four regions in the United States.~   "
31417|NCT03155828|"~     The purpose of this study is to determine if treatment of obstructive sleep apnea (OSA) with~     continuous positive airway pressure in women with both OSA and polycystic ovarian syndrome~     will improve the regularity of the women's menstrual cycles.~   "
31418|NCT03155815|"~     The purpose of this study is to develop and validate the Dementia Population Risk Tool~     (DemPoRT) algorithm to predict dementia incidence in the population setting.~   "
31419|NCT03155802|"~     This is a pilot prospective cohort study, in adult female subjects 18-85 years old with a~     diagnosis of invasive breast cancer who are planned for anthracycline-inclusive chemotherapy~     and followed up for a time period of 6 months post completion of anthracycline chemotherapy.~     They will participate in blood and imaging tests with a goal of determining the best method~     for predicting the occurrence of cardiotoxicity in this subpopulation.~   "
31420|NCT03155789|"~     The main objective of this prospective study is to compare the clinical outcomes after lumbar~     fusion for chronic low back pain using the four techniques commonly employed in our surgical~     practice. Lumbar fusion stops motion at a painful vertebral segment, which can decrease back~     pain. The four techniques are standard transforaminal lumbar interbody fusion (S TLIF),~     minimally invasive transforaminal lumbar interbody fusion (MI TLIF), extreme lateral~     interbody fusion (XLIF), and axial lumbar interbody fusion (AxiaLIF). Each differ in where~     incisions are made and level of invasiveness; not all may be implemented in each surgical~     case. The four different techniques are all standard approaches with different advantages and~     have yet to be compared in efficacy for relieving chronic low back pain.~   "
31421|NCT03155776|"~     Aspiration of gastric contents can be a serious anesthetic related complication. Gastric~     antral sonography prior to anesthesia may have a role in identifying pediatric patients at~     risk of aspiration. The investigator examined the relationship between sonographic antral~     area and endoscopically suctioned gastric volumes infants.~   "
31422|NCT03155763|"~     The morphology of transplanted kidney is considered to be important for graft outcomes in~     early and late posttransplant period. Individual histological lesions at the time of kidney~     transplantation, such as sclerosis of glomeruli, vascular narrowing and interstitial~     fibrosis, and composite histological lesions, which integrate histopathological findings in~     different compartments, showed association with suboptimal graft outcomes. However there are~     no consistent association between individual or composite lesions and transplant outcomes.~     Some possible explanations for such inconsistent results are non-uniformity in grading~     histological lesions or in defining graft outcomes. Furthermore, studies vary in terms of~     patient selection, and some results are not corrected for covariates. It is also unclear,~     whether acute biopsy features associated with the donor kidney can provide prognostic~     information, in addition to the chronic lesions? This single-center study aimed to evaluate~     which acute and chronic histological lesions and composite histological scores in donor~     kidney intraoperative biopsies alone or in combination with clinical variables are best~     associated with short- and long-term kidney graft outcomes, such as impairment of early~     kidney allograft function, immunological acute kidney allograft rejection, pyelonephritis,~     allograft function at 1, 3, 6, 12 months, 2, 3, 4 and 5 years, and graft survival at 1 and 5~     years.~   "
31423|NCT03155750|"~     Objectives: To evaluate the clinical effects of Zero-Time Exercise (ZTEx) for treating~     insomnia disorder delivered by a training course.~      Hypothesis: Subjects in the ZTEx training group will have greater improvement in insomnia~     symptoms and daytime impairment than those in the sleep hygiene education (SHE) group at week~     8.~      Design and subjects: A randomized controlled trial. 32 inactive subjects with insomnia~     disorder recruited from the community will be randomized to ZTEx training or SHE groups in a~     1: 1 ratio.~      Study instrument: Insomnia Severity Index (ISI) will be used to assess insomnia symptoms and~     daytime impairment.~      Interventions: Subjects in the ZTEx training group will attend two training lessons (2-hour~     each) to learn ZTEx and practice it every night for 8 weeks; subjects in the SHE group will~     receive sleep hygiene education with the schedule and duration that are same to the ZTEx~     training group.~      Main outcome measures: The primary outcome measure is the ISI score. Other measures include~     sleep parameters by subjective sleep diary and objective actigraphy, Hospital Anxiety and~     Depression Scale, Multidimensional Fatigue Inventory-20 and Short Form-6 Dimension.~     Acceptability and compliance of ZTEx will be evaluated.~      Data Analysis: Differences in the questionnaire scores, subjective and objective sleep~     parameters will be examined using a mixed-effects model.~   "
31433|NCT03155620|"~     This Pediatric MATCH screening and multi-sub-study phase II trial studies how well treatment~     that is directed by genetic testing works in pediatric patients with solid tumors,~     non-Hodgkin lymphomas, or histiocytic disorders that have progressed following at least one~     line of standard systemic therapy and/or for which no standard treatment exists that has been~     shown to prolong survival. Genetic tests look at the unique genetic material (genes) of~     patients' tumor cells. Patients with genetic changes or abnormalities (mutations) may benefit~     more from treatment which targets their tumor's particular genetic mutation, and may help~     doctors plan better treatment for patients with solid tumors or non-Hodgkin lymphomas.~   "
44943|NCT02978560|"~     The aim of this project is to demonstrate that fluorescence-mediated photoplethysmography~     (FM-PPG) is capable of routinely acquiring the tissue perfusion data sufficient to detect and~     monitor skin tissue perfusion anomalies.~   "
31424|NCT03155737|"~     Objectives: To test the feasibility of the study design and clinical effects of~     self-administered acupressure on relieving knee osteoarthritis (OA) pain.~      Hypothesis: self-administered acupressure would have a superior beneficial effect compared to~     health education control group in terms of pain relief in patients with knee osteoarthritis~     across the 6-week study period.~      Design and subjects: A pilot randomized controlled trial. 36 subjects with knee OA will be~     recruited; 18 per group. All eligible subjects will be randomized to either self-administered~     acupressure or health education control group in 1:1 ratio.~      Interventions: Subjects in the self-acupressure group will attend two 1.5 hours training~     sessions to learn self-acupressure and will practice self-acupressure every morning and night~     for 6 weeks; subjects in the education control group will receive two 1.5 hours training~     sessions to learn the health information related to knee OA.~      Main outcome measures: The primary outcome measure is the numerical rating scale for knee~     pain. Other measures include Western Ontario and McMaster University Osteoarthritis Index,~     knees' range of motion (ROM), and SF-6D. Acceptability of the self-acupressure training~     course will also be evaluated.~      Data Analysis: Differences in the questionnaire scores and ROM will be examined using a~     mixed-effects model. Both completer and intention-to-treat analyses will be conducted. Effect~     sizes will be computed by dividing the difference in means by the pooled standard deviation.~   "
31425|NCT03155724|"~     The objective of this MultiPole Pacing (MPP) sub-study of the QP ExCELs study is to~     demonstrate that the MPP feature is effective by converting a percentage of cardiac~     resynchronization therapy (CRT) non-responders to responders. The MPP sub-study is a~     single-arm, multi-center, prospective trial within the ongoing QP ExCELs study (NCT02290028).~   "
31426|NCT03155711|"~     This study aims to compared the effects of high flow nasal during the induction and during~     the weaning of anesthesia on intraoperative and postoperative oxygenation and postoperative~     atelectasis in obese patients undergoing bariatric surgery versus the standard of care, which~     consists in supplemental oxygen with face mask (Venturi mask).~   "
31427|NCT03155698|"~     Vitiligo is a relatively common acquired chronic disorder of pigmentation characterized by~     the development of white macules on the skin due to loss of epidermal melanocytes .Affecting~     approximately 0.5%-2% of general population worldwide, without predilection for sex or race.~   "
31428|NCT03155685|"~     There are not lots of recommendations for the use of antipsychotics in palliative care. The~     National Agency for Accreditation and Evaluation in Health (ANAES) and the French Society for~     Accompaniment and Palliative Care, in 2002, make it the first-line treatment for confusion in~     palliative care, but there are no information on the molecules to be used, the dosage or the~     route of administration.~      Many symptoms can motivate the prescription of an antipsychotic and many molecules exist.~     Their mode of action is substantially the same but their pharmacological properties sometimes~     give them different beneficial effects or side effects. They are studied in psychiatry but~     very little in palliative care.~      Depending on the symptom (s) presented by the patient, either of these antipsychotics may be~     preferred. Use appear to differ from one center to another.~      The investigator propose a multicenter, prospective, observational study describing the~     antipsychotics used according to the symptom.~      This study should include 100 patients over the age of 18 years in palliative care~     (regardless of pathology) who are not taking antipsychotics and for whom the decision to~     introduce an antipsychotic is made regardless of the symptom.~      The purpose of this work is to describe the most commonly used antipsychotic according to a~     particular symptom, as well as the dosage and route of administration.~      The investigator will also evaluate the 7-day efficacy of the chosen antipsychotic on the~     symptom that motivated the prescription, and we will compare the dosages of the associated~     treatments before and after the introduction of this new treatment.~   "
31429|NCT03155672|"~     To gain understanding about the impact of visual art making on biomarkers, such as cortisol,~     alpha amylase, oxytocin, etc. to examine whether and to what extent there are changes in~     levels of stress and immune function in patients and caregivers adults (including family~     caregivers and medical professionals)~   "
31430|NCT03155659|"~     Data linking fish, polyunsaturated fatty acids intake and mortality are lacking and~     conflicting. We aim to use data from the China Health and Nutrition Survey (CHNS) and~     National Health and Nutrition Examination Survey (NHANES) to investigate the associations of~     fish and polyunsaturated fatty acids (PUFA) intake with mortality in Chinese and US~     populations. The study findings will be informative for addressing the role of fish and~     specific PUFA in human health and improve basis for dietary recommendations.~   "
31431|NCT03155646|"~     A laparoscopic approach offers several advantages over an open procedures; potentially~     reduces the surgical stress and fluid shifts that may accompany it; in addition there is less~     need for postoperative analgesia, reduction of postoperative respiratory and wound~     complications.~      Despite the minimally invasive nature, pain can be moderate to severe in the immediate~     postoperative period that requires multimodal analgesia. Inadequate control of post-operative~     pain leads to several unwanted adverse events ranging from patients' discomfort and prolonged~     immobilization to thromboembolic phenomenon and pulmonary complications.~      Transversus abdominis plane (TAP) block is a type of peripheral nerve block that involves~     innervation of the anterolateral abdominal wall. With the aid of ultrasound, local anesthetic~     (LA) is injected into the transversus abdominis fascial plane, where the nerves from T6 to L1~     are located.~      Ultrasound TAP block is accompanied by a good pain relief and reduced intraoperative and~     postoperative opioids requirements after laparoscopic surgery. In this case a bilateral TAP~     block is necessary because the abdominal skin incisions for the ports of laparoscopic~     procedure are performed on both sides.~      Unfortunately, TAP block duration is limited to the effect of administered LA. Recently,~     adjuvant medications were added to LA to prolong the effect of TAP block. Dexmedetomidine is~     a selective alpha 2 (α2) adrenergic agonist with both analgesic and sedative properties. Its~     use with bupivacaine either epidurally or intrathecally is associated with prolongation of~     the LA effect. A major advantage of dexmedetomidine is its higher selectivity compared with~     clonidine for α2A receptors, responsible for the hypnotic and analgesic effects of such~     drugs.10 Clonidine action, similar to local anesthetic action, and its interaction with local~     anesthetics have been explained by three possible mechanisms. First, clonidine blocks Ad and~     C fibers. Secondly, clonidine may cause local vasoconstriction, thus decreasing local~     anesthetic spread and removal around neural structures. Thirdly, clonidine used in peripheral~     blocks intensifies and prolongs analgesia.~   "
31432|NCT03155633|"~     This study has as main objective to know how the processes of recovery are realized after a~     race of marathon. For this, the participants of a marathon race are divided into three work~     groups during the 9 days post-marathon, one with rest in the recovery period, another with~     continuous race three sessions every 48h and another with three sessions of elliptical every~     48h .~   "
31450|NCT03155399|"~     The purpose of this study is to evaluate the effect of the repetitive proprioceptive~     bilateral stimulation for the early recovery of the voluntary muscle contraction in stroke~     patients.~   "
31434|NCT03155607|"~     Burn wounds cause intense, complex pain, and subsequent burn wound care causes further~     intense, episodic pain that is often unrelieved by opioid and non-opioid medications,~     resulting in under-treatment of pain. Further, opioid analgesics can have untoward side~     effects including respiratory depression, nausea, constipation, pruritus, drowsiness,~     lethargy, dependence, and induced hyperalgesia. As one of the most severe types of pain, burn~     wound care pain adds to the trauma pediatric patients already experience from the burn itself~     impacting quality of life with subsequent behavioral and maladaptive responses, such as~     agitation, anger, anxiety, hyperactivity, uncooperativeness, aggression, and dissociation.~     Lack of control over the procedure, pain memory, anxiety in anticipation of the repeated~     painful nature of the procedure, and transmission of clinician distress associated with~     inflicting procedural pain on the child contribute to the pain perceived.~      Virtual reality (VR) shows great promise as an engaging, interactive, effective~     non-pharmacologic intervention for various painful healthcare procedures, including burn~     wound care, therapies, and chronic pain conditions, despite equivocal findings, perhaps due~     to methodological issues. Designs of many studies of VR during burn wound care have been case~     studies or carefully controlled within-subject designs; sample sizes have been small.~     Recommendations for ongoing research include conducting more rigorous studies including~     randomized controlled trials (RCTs), repeat design studies, testing VR throughout the~     healthcare procedure, comparing VR to other distraction interventions; and using larger~     sample sizes.~      Primary Aim 1: Compare the effectiveness of age-appropriate, consumer available, high~     technology, interactive VR with standard care (SC) on adolescents' acute procedural pain~     intensity perception during burn wound care treatment in the ambulatory outpatient clinic~     setting.~   "
31435|NCT03155594|"~     A pilot study using the FreeStyle Libre to assess its potential benefits in patients with~     diabetes starting when they are inpatients and continuing during the transition of care to~     the outpatient setting to see if diabetes care can be improved after discharge.~      This study is designed to address the following questions:~        1. How do the glucose readings from FreeStyle Libre Pro compare to our inpatient glucometer~          system? Is the system is accurate enough to use for clinical decision making?~        2. How often does the additional continuous glucose data change inpatient care?~        3. Does this technology work with inpatient nursing workflow?~        4. Does leaving the patch on at discharge and reading in the office improve transition of~          care?~        5. Does reading the patch after discharge in the office improve follow-up care?~   "
31436|NCT03155581|"~     Although health-related interventions should become increasingly diversity-sensitive, there~     will always be a need of adapting specific interventions to some immigrant populations.~     Adapting selected services to the individual cultural and religious background is necessary~     to reduce health inequalities and provide effective health care and is dependent on the~     active involvement of users. In this proposal the investigators present a community-based~     health intervention trial with two parallel interventions aimed at increasing participation~     of immigrant women to the existing cervical cancer-screening program. Through this study, the~     investigators will provide new practice-based knowledge and a firmer evidence base to improve~     health interventions that can contribute to equal health care and good health for all -~     including the immigrant population.~      Based on identified barriers and factors that influence the interactions between immigrants~     and health care professionals for screening of cervical cancer in Norway, the investigators~     have develop two adapted interventions. One strategy will target immigrant women, and the~     other one will focus on general practitioners. Thus, this proposal will specifically~     contribute to the development of personalized health prevention interventions for the most~     common cancer-screening program in Norway, with a focus on immigrant's personal circumstances~     and health care needs.~   "
31437|NCT03155568|"~     Diabetic patients suffering diabetic foot disease have sever comorbidities, as hypertension,~     ischemic heart disease, autonomic neuropathy, infections and gastric reflux all of which~     contribute to a high risk profile for anesthesia.~      failure rate associated with ankle or popliteal nerve block may be higher than accepted, the~     study hypothesized that combined ankle and popliteal block may increase the success rate with~     no added complications.~   "
31438|NCT03155555|"~     The purpose of this study is to evaluate whether carotid Doppler peak systolic velocity can~     be an easy to measure possible surrogate for echocardiographic measurement of aortic peak~     systolic velocity variation which is an index of fluid responsiveness in mechanically~     ventilated children intra-operatively.~   "
31439|NCT03155542|"~     According to the statistic reports from World Health Organization (WHO) International Agency~     for Research on Cancer (IARC), the incidence and mortality rate of colorectal cancer ranked~     third and fourth respectively among ten most commonly diagnosed cancer worldwide; moreover,~     based on the statistics from Health Promotion Administration, Ministry of Health and Welfare~     in Taiwan, the incidence and mortality rate of colorectal cancer ranked second and third~     respectively among call cancer in Taiwanese population. However, if colorectal cancer is~     diagnosed and treated in early phase, the 5-year survival rate for stage I colorectal cancer~     can be up to 90%; on the other hand, the 5-year survival rate for end stage colorectal cancer~     is only approximately 10%. Therefore, the screening, early diagnosis od colorectal cancer is~     crucial. To date, there are some known risk factors for colorectal cancer, including familial~     adenomatous polyposis, obesity, physical inactivity, etc. Alcohol had also been identified as~     an important risk factor for colorectal cancer, and the risk could be higher among Asian~     population because of the reduced enzymatic activity of some of the alcohol metabolizing~     enzymes. Thus, through this study, the investigators hope to find out the risk factors of~     colorectal cancer among Taiwanese population, including alcohol metabolizing enzyme gene~     polymorphisms and their interaction with environmental factors, to attain the purpose of~     early prevention of colorectal cancer.~   "
31451|NCT03155386|"~     This study will be proposed consecutively to any patient who angiomammography examination was~     requested by the clinician in charge of patient. A randomization will be performed between an~     angiomammography examination Standard (SenoBright®) and an optimized angiomammography~     examination.~      A blinded central re-reading of the acquisition technique will be carried out by 3~     radiologists (2 seniors and 1 junior) who will evaluate:~        -  The intensity of lesion enhancement~        -  The presence and type of artefacts on the recombined images.~        -  The quality of low-energy images according to recognized criteria for mammography.~      The gold standard will be histology (biopsies or surgery) or follow-up to 1 year for~     non-biopsied benign lesions~   "
31550|NCT03154099|"~     the detrimental impact of dysfunction is well recognized. CIRCI may be characterized by any~     of the following findings with delayed weaning from mechanical ventilation and hypotension~     refractory to fluids and vasopressors being most common Hypotension Unresponsiveness to~     catecholamine infusions Ventilator dependence Abdominal or flank pain High fever with~     negative cultures and unresponsive to antibiotic therapy Unexplained mental changes (i.e.,~     apathy or depression) Electrolyte abnormalities (hypoglycemia, hyponatremia, hyperkalemia)~     Neutropenia, eosinophilia~   "
31440|NCT03155529|"~     Cervical cancer is one of the most prevalent malignancies in female .To the younger patients,~     radical hysterectomy which is a standard operation during the earlier and middle therapy~     stage as well as more effective technique like radiotherapy and chemotherapy give them a~     longer life expectancy. However, the operation destroys patients' normal pelvic anatomy,~     nutrient supplements and internal secretion so that postoperative pelvic floor functional~     dysfunction has a destructive effect for their life. There are tremendous studies on clinical~     symptoms while few on anatomical changes and the relationship between pelvic floor symptoms~     and the dysfunction. Two-dimensional Magnetic Resonance Imaging(MRI), transperineal~     ultrasonography， Urodynamic examination and anorectal manometry are frequently used in the~     fine-structure varies and pelvic floor function. Now three-dimensional MRI has more~     advantages in fine change of Pelvic anatomical and space position，as well as clearly showing~     the relationships between the change and space with the pelvic floor function. Based on an~     eight-year-study on three-dimensional MRI, we can analyze the postoperational anatomical~     changes and the relationship between the changes and the dysfunction by combined anatomic~     parameters which are measured on static-dynamic three- dimensional model with clinical~     symptoms, transperineal ultrasonography,urodynamic examination and anorectal manometry. We~     expect our study could provide scientific basis for on protective and repaired measures of~     pelvic floor.~   "
31441|NCT03155516|"~     This study aims to set up a standardized cancer pain ward - known as the Good Pain Management~     (GPM) Ward with streamlined assessment and management procedures to act as a pain management~     model. In particular, it will enforce regular pain assessment from and throughout hospital~     admission, and treatment protocols introducing the use of strong-opioids in moderate cancer~     pain patients, following National Cancer Care Network (NCCN) Adult Cancer Pain Guidelines.~     The GPM ward will be compared against current-practice controlled ward.~   "
31442|NCT03155503|"~     This is a Phase 1, conventional, double-blind, placebo-controlled, single-center clinical~     study comprised of 2 segments (Segment 1 and Segment 2) in which single and multiple doses of~     SUVN-911 or placebo will be orally administered to healthy male subjects to evaluate the~     safety, tolerability, and pharmacokinetic profile.~   "
31443|NCT03155490|"~     Brief Summary: Trauma is a major public health burden; it is the fifth most common cause of~     mortality overall in the US and accounts for the majority of deaths in patients younger than~     45. Trauma resuscitations present unique patient care challenges due to the need to perform~     complex tasks under uncertain and time-pressured conditions. It is not entirely surprising~     that one-third to one-half of trauma patient-related errors occurred in emergency departments~     during the initial resuscitation period. Effective team leadership can enhance teamwork and~     team adaptability, thus improving teams' ability to handle unexpected and rapidly changing~     situations. Simulation-based training provides a clinically relevant practice environment~     that has been recommended for team and team leader training.~      The purpose of this research is to evaluate the impact of simulation-based leadership~     training on clinical teamwork, team leadership and patient care. The investigators~     hypothesize that team leadership training will improve team leadership, teamwork, and~     critical patient care events during actual trauma resuscitations.~   "
31444|NCT03155477|"~     This a double blind randomised controlled trial (RCT) to determine the effect of Curcuma~     Xanthorrhiza supplementation on vitamin D3 administration to disease activity (SLEDAI), IL-6~     and TGF-β1 serum in SLE patients with hypovitamin D. SLE patients with hypovitamin D had~     milder disease activity, lower IL-6 and higher TGF-β1 serum level when supplemented with~     Curcuma Xanthorrhiza and vitamin D3 compared with vitamin D3 and placebo.~   "
31445|NCT03155464|"~     The primary objective of this study is to evaluate the relative intraoperative improvement in~     perfusion between arterial reconstruction and sympathectomies with quantitative ICG. A~     minimum of 40 patients, 20 Sympathectomy Prior to Bypass (group 1) and 20 Bypass Prior to~     Sympathectomy (group 2), will be recruited for this study. This study will enroll~     participants in a one to one randomized study design. There is the potential risk of loss of~     confidentiality. The study involves the intraoperative assessment of perfusion by~     quantitative ICG. ICG is FDA approved for this usage and will be used according to its~     labeling. Assessment involves intraoperative quantitative ICG data, questionnaires, and~     patient and physician assessments. There are no additional physical risks associated with~     participating in this study over and above that of the planned arterial reconstruction~     (bypass) and sympathectomies.The information collected will be kept confidential and will~     comply with the HIPAA.~   "
31446|NCT03155451|"~     Epithelial ovarian cancer constitutes one of the most common gynecological~     malignancies.Because the ovaries lie in the deep pelvic cavity,most ovarian cancer patients~     are asymptomatic, rendering the majority often diagnosed at an advanced stage.ctDNA in cancer~     patients often bears similar genetic and epigenetic features to the related tumor DNA.This~     study aims to detect plasma ctDNA in Diagnosis of Epithelial Ovarian Cancer.~   "
31447|NCT03155438|"~     In Vitro Fertilization is considered one of effective treatment for infertile couple.~     However, some women do not have adequate response to controlled ovarian hyperstimulation,~     resulting in low response which defined as less than 5 retrieved oocytes. There are studies~     claiming that live birth rates in these patient lower than normal responder (10-15 retrieved~     oocytes). Among factors contributing low response, oxidative stress, resulting from increased~     pro-oxidant and/or reduced antioxidant, is considered to effect the functions of follicles~     and quality of oocytes. However, there are few studies demonstrating this relation. Objective~     of our study is to find the difference of oxidative stress-related gene expression in cumulus~     cell and oocyte competence biomarkers from follicular fluid between low responders and normal~     responder to controlled ovarian hyperstimulation.~   "
31448|NCT03155425|"~     This is an open-label, multicenter, non-randomized, phase2 trial to evaluate efficacy and~     safety of SHR-1210 in patients with relapsed or refractory classic Hodgkin's lymphoma. The~     primary objective is to assess ORR of SHR-1210 in patients with relapsed or refractory~     classic Hodgkin's lymphoma.~   "
31449|NCT03155412|"~     The goal of the study is to analyze deviations in adipogenic potential and metabolic~     properties of preadipocytes in subjects with genetic predisposition to type 2 diabetes, and~     thus identify factors that underlie hypertrophic growth of adipose tissue associated with the~     development of this disease.~   "
31452|NCT03155373|"~     Mitral regurgitation (MR) is a prevalent valvular heart pathology. Indications for surgery~     include symptoms, impaired left ventricular function or enlarging dimensions, new onset~     atrial fibrillation, pulmonary hypertension, asymptomatic status with a high likelihood of~     success.~      Asymptomatic severe primary MR can be initially monitored without impairing long term~     survival. However, significant symptoms or impairment of left ventricular function is~     associated with worse prognosis due to long term heart failure. Some physicians wait for~     early symptoms before referring for surgery and this is reflected by a great variation in~     referral patterns, but symptomatic status is subjective and difficult to assess. Nearly all~     of the surgical indications are based on expert opinion rather than significant evidence~     base.~      The primary aim of this project is to improve the current guidelines for surgery for primary~     MR by finding an objective marker of functional capacity which correlates with surrogates of~     prognosis and detects early decline, but returns to normal after surgery.~   "
31453|NCT03155360|"~     According to recent studies, we want to find evidences that infant colics could be a episodic~     symptom associated to migraine as cyclic vomiting syndrome or abdominal migraine are. The~     main purpose is to compare the presence of colics in infants between 60 days and 180 days of~     life and the presence of migraine in their parents to determine if colicky children's parents~     are more migrainous than other parents.~   "
31454|NCT03155347|"~     This is a randomized, double-blind, multi-center, parallel-group study to evaluate the~     efficacy and safety of subcutaneous (SC) tocilizumab (162 milligrams [mg] every 2 weeks~     [Q2W]) given as monotherapy and in combination with MTX versus MTX given as monotherapy, in~     participants with moderate to severe active rheumatoid arthritis (RA) who have inadequate~     response to current DMARD therapy. The study comprises a 24-week double-blind treatment~     phase, followed by a 24-week extension phase.~   "
31455|NCT03155334|"~     The purpose of this randomized, open label, crossover, single site study is to compare the~     PISs of two Multiple Sclerosis clinical trials to elucidate potential aspects of the given~     written information that could impact on the smooth running of the studies.~   "
31456|NCT03155321|"~     The study is designed to assess the awareness of the SAGES Safe Cholecystectomy Program among~     polish surgeons, as well as the degree of implementation of this Program during laparoscopic~     cholecystectomy performed in Poland. It also gathers the opinion of polish surgeons on~     usefulness of each of the SAGES Safe Cholecystectomy Rules~   "
31457|NCT03155308|"~     Colorectal cancer (CRC) is the most frequent gastrointestinal tumor and the second cause of~     cancer related death. Colonoscopy is currently the recommended method for detection of polyps~     and cancers in the colon. Removal of all adenomatous polyps during colonoscopy has become~     worldwide a standard procedure as it has been demonstrated to significantly reduce colorectal~     cancer incidence and mortality. It is routine practice to remove all the detected polyps for~     pathological evaluation, due to the low accuracy (59% to 84%) to differentiate non-neoplastic~     from neoplastic colorectal lesions with white-light endoscopy. The development of electronic~     or virtual chromoendoscopy (CE) has aimed to reliably predict histology of colorectal lesions~     based on endoscopic features. This technology differentiates between neoplastic and~     non-neoplastic lesions base on the analysis of the neo-angiogenesis and the mucosal pit~     pattern. Optical endoscopic diagnosis allows the real-time evaluation of polyp histology~     during colonoscopy and to determine the appropriate therapeutic strategy. This is important~     in clinical practice, since adenomas or superficial invasive submucosal carcinoma lesions can~     be curatively treated by endoscopic removal, unlike deeply invasive carcinomas, which~     requires surgery. The Narrow-band imaging (NBI) international colorectal endoscopic (NICE)~     classification is validated classification system proposed as a valid tool for not only~     differentiating hyperplastic from adenomatous polyps, but also predicting submucosal deep~     (SM-d) carcinomas. It was developed based on NBI technology, leaving uncertainty on its~     applicability to other systems. It was previously evaluated the application of the NICE~     classification to Fujinon spectral Imaging Color Enhancement (FICE) technology founding~     suboptimal results (accuracy 77%, sensitivity 77% and specificity 75%) and moderate~     inter-observer agreement (kappa: 0.51).~   "
31458|NCT03155295|"~     The purpose of the study is to evaluate patient-specific surgical simulation by permitting~     pre-operative rehearsals, in the form of the surgeon completing a dry run of the procedure on~     a model constructed from the patient's radiological studies that replicates every aspect of~     their organs. The investigators' aim is to evaluate the effectiveness of this form of~     practice in optimizing intraoperative and postoperative outcomes . The investigators hope~     eventually to use these rehearsals as a standard study tool for surgical training.~   "
31459|NCT03155282|"~     Patients with cirrhosis have structural and functional alterations of the liver. The~     progressive deposition of hepatic fibrosis is related to the subsequent development of portal~     hypertension (PH), and PH is associated with mayor complications including ascites, hepatic~     encephalopathy and development of gastroesophageal varices with a high risk of bleeding.~     Variceal bleeding is a medical emergency associated with a 6-week mortality rate of~     approximately 10-20%. Liver biopsy is the gold standard for the assessment of hepatic~     fibrosis, whereas the measurement of hepatic vein pressure gradient (HVPG) is the standard to~     evaluate PH and upper endoscopy (UE) is the method of choice to detect the presence and grade~     of gastroesophageal varices. The last two also estimates the risk of variceal bleeding.~     Unfortunately, clinical investigation of PH implies HVPG measurement or endoscopy for~     esophageal varices (EV) screening and grading. The first one is an invasive technique, mainly~     restricted to tertiary centers, that requires personal training, increased health care costs~     and patient discomfort. The UE, even though has demonstrated utility to predict HVPG (HVPG~     value ≥ 10 mmHg predicts the presence of EV and a value ≥ 12 mmHg is predictive for variceal~     bleeding), has been criticized of being subjective. Because of this, alternative test~     including elastographic techniques, have been develop to assess the severity of PH, the~     presence of EVs and the risk of variceal bleeding. Elastography is a technique used to~     measure tissue elasticity and stiffness in real time, by the application of slight~     compression using a transducer to the targeted tissue. The principle is that tissue~     compression produces deformation (strain) and that the strain is smaller in harder tissue as~     compared to softer tissue. Consequently, by measuring the tissue strain induced by~     compression, it is possible to estimate the tissue hardness. Fibroscan® (FS) (Echosens,~     París, Francia) uses the principle of one-dimension transient elastography (TE) for the~     assessment of tissue stiffness. It was used initially for liver stiffness measurement (LSM)~     and proved to be reliable for the diagnosis of liver cirrhosis and avoid liver biopsy in 90%~     of cases. Also LSM by TE accurately correlates with the severity of PH and the presence of~     esophageal varices.~   "
31460|NCT03155269|"~     To investigate the effect of nutritional supplement on bone turnover markers (which are~     sensitive and respond quickly to nutrition or drug intervention) in Indian healthy~     premenopausal women after 6 months of intervention.~   "
31484|NCT03154957|"~     The analysis of professional practices in the emergency department of the Strasbourg CHRU in~     the management of acute shoulder dislocations aims at proposing a clinical pathway of~     synthesis taking into account current practices and data from the literature. Thus, the~     objectives are twofold: first standardize care in emergency rooms and try to improve the weak~     points of this care.The Investigators will concentrate thier observation work on the~     medicinal analgesic methods proposed to these patients in order to minimize the pain induced~     by the external reduction maneuvers performed, in the majority of cases, in the emergencies.~     This work will ultimately have a real clinical impact on the management of these traumatized~     patients~   "
31485|NCT03154944|"~     This investigation evaluates three new ostomy appliances and their impact on the peristomal~     skin.~   "
31461|NCT03155256|"~     Bleeding from gastric varices (GV) is associated with high mortality. Injection of~     cyanoacrylate (CYA) using standard gastroscopes has demonstrated higher hemostasis and lower~     rebleeding rates compared to band ligation or sclerotherapy. Nevertheless CYA treatment is~     known to be associated with significant adverse events. Pulmonary embolism due to CYA~     injection is a serious and sometimes fatal complication of this therapy. Romero-Garcia et al.~     recently showed that, even these patients usually have respiratory symptom, this complication~     can be present in asymptomatic patients and with only CT pathological images showing it. On~     the other hand, risk of glue embolism, has been described to be dependent on the volume of~     CYA injected, being significantly greater with high volume. Other complications related to~     CYA injection are, hemorrhage from post injection ulcers, fever, peritonitis, needle~     impaction, and even death. Also the injection material can cause serious damage to the~     endoscope.~      Currently endoscopic treatments are CYA injection under direct visualization using a standard~     gastroscope and treatment under EUS guidance with injection of CYA, coils or both. However,~     to date, it is unknown whether one of these techniques is technically more feasible or causes~     less adverse events than the other.~      Treatment under EUS guidance may improve results because of precise targeting of the varix~     lumen or afferent feeding veins. This allows the vein to be obstructed with a small amount of~     CYA, less than used for the blind injection of GV with standard endoscopic technique and~     may reduce the risk of glue embolism. EUS can confirm varix obliteration by using Doppler.~     Also visualization of GV by using EUS is not impaired by blood or food in the stomach and~     thus can be performed in the setting of active hemorrhage.~   "
31462|NCT03155243|"~     This study aims at evaluating real life effectiveness of originator adalimumab (Humira®)~     participants with active non-infectious intermediate, posterior and panuveitis (NIIPPU)~     despite high-dose corticosteroid therapy; including effect on ocular inflammation,~     health-related quality of life, health resource utilization, work ability and medication~     burden, as well as describe the characteristics of NIIPPU participants treated with Humira®~     in the real-life setting.~   "
31463|NCT03155230|"~     Danish male patients who had undergone bilateral TAPP (July 2012 to June 2013) were recruited~     from the Danish Hernia Database and cross-checked with hospital files and the National~     Patient Registry. A standardized postal questionnaire was sent out two years after the index~     surgery to investigate Patients Related Outcome Measures (PROMs) such as chronic~     post-operative pain.~   "
31464|NCT03155217|"~     Since 2013, therapeutic care of metastatic melanoma (MM) has greatly improved, especially~     thanks to BRAF and MEK targeted therapies. The efficacy of these treatments that are now used~     daily at first line for BRAF mutated MM is widely approved. Their toxicities, in monotherapy~     or in association, are also well-known: fever, arthralgias, digestive disorders, cutaneous~     rash, fatigue, photosensitivity, alopecia, cutaneous hyperkeratosis, squamous cell~     carcinomas, keratoacanthomas, de novo melanomas… However, onco-dermatologists are more and~     more faced with MM of elderly patients. Indeed, life expectancy continues to increase and the~     over-75-year-old age group is becoming larger. These patients are still active but much more~     vulnerable. Nevertheless, there is no data in the literature for this fragile population~     except the MM pivotal studies subgroups of those over 65-year-old. The results vary with~     different regimens. Therefore, there is a wide lack of information that could help make a~     therapeutic decision, inform patients, prevent or treat side effects of BRAF and MEK~     inhibitors in elderly patients~   "
31465|NCT03155204|"~     The purpose of this study is to compare the absorption of four different inhalation products~     with the reference product in healthy volunteers.~   "
31466|NCT03155191|"~     Evaluate the safety (P-I), pharmacokinetics and anti-tumor effect of immunotherapy of~     autologous T cells genetically modified to express anti-CD19 chimeric antigen receptor (CAR)~     (TBI-1501) for relapsed or refractory CD19+ B-cell acute lymphoblastic leukemia.~   "
31467|NCT03155178|"~     The objective of the study is to demonstrate persistent effect of the CHG/IPA Prep on skin~     flora of the abdomen and inguinal regions of human subjects.~   "
31468|NCT03155165|"~     Colonoscopy is considered the gold standard for colorectal polyp and cancer detection.~     However, even meticulous colonoscopy substantial numbers of colorectal polyps may be missed~     and carcinomas may not be prevented. Previous studies have found a 12-28% of miss rate for~     all polyps, a 31% for hyperplastic polyps and 6-27% for adenomas, with the higher miss rates~     noted for smaller polyps. The lesions missing rate depends on several factors as the location~     on difficult areas to be evaluated with conventional colonoscopes (the proximal side of the~     ileocecal valve, haustral folds, flexures or rectal valves), a flat shape, a poor bowel~     preparation and inadequate endoscopy technique, particularly rapid colonoscope withdrawal.~     Using the commonly available 140º angle of view colonoscope, approximately 13% of the colonic~     surface is unseen. The incorporation of colonoscopes with a 170-degree wide angled could not~     improve adenoma detection rate. The introduction of high definition (HD) colonoscopes and~     visual image enhancement technologies as narrow band imaging (NBI, Olympus America, Center~     Valley, PA), i-SCAN™ (PENTAX of America, Montvale, NJ) and Fuji Intelligent Chromo-Endoscopy~     (FICE™, Fujinon Endoscopy, Wayne, NJ) have improved the lesion characterization, but several~     studies proved no increase in adenoma detection rates. The Third Eye Retroscope (Avantis~     Medical Systems, Sunnyvale, CA) is a disposable retrograde viewing device advanced via the~     accessory channel of a standard colonoscope. Allows retrograde views behind colonic folds and~     flexures simultaneously with the forward view of the colon. Although it was shown an increase~     in adenoma detection rate by 11%-25%, it has many disadvantages. It requires a separate~     processor and the device is disposable making the cost bigger. Occupies the working channel~     of the colonoscope which limits the ability to suction. If a polyp is seen the viewing device~     has to be removed in order to perform the polypectomy. The optic is not high definition and~     finally, the endoscopist has to get used to visualizing and processing two simultaneous video~     streams from the colonoscope and from the retroscope device.~   "
31469|NCT03155152|"~     Different types of high-intensity interval training (HIIT) sessions are used by athletes in~     order to improve their physical performance, but innovative approaches to training are~     lacking. Therefore, in Part A of this study the physiological response to a standard HIIT and~     a new decremental exercise training (DECT) will be compared in runners and cyclists. Next, in~     Part B the training effects of a 4-week block of the HIIT and DECT will be compared.~   "
31470|NCT03155139|"~     To investigate the prevalence of primary aldosteronism (PA) in Chinese patients with~     hypertension.~   "
31471|NCT03155126|"~     The goal is to observe that the incidence of acute kidney injury in patients who need fluid~     resuscitation when resuscitated with saline or acetated Ringer's sodium.~   "
31486|NCT03154931|"~     The purpose of this study is to determine the efficacy of a 8-week program of Compassion~     Focused Therapy in Group comparing to Supportive Cognitive Behavioral Therapy in Group for~     patients with Posttraumatic Stress Disorder.~   "
31487|NCT03154918|"~     This study is to explore the efficacy and safety of GLIDE regiment in patients with~     aggressive NK/T cell lymphoma.~   "
31472|NCT03155113|"~     Anti-viral, hepatitis C virus (HCV)-specific immune T cell responses are functionally~     defective in patients with chronic hepatitis C and this functional impairment is believed to~     contribute to virus persistence. Persistent exposure to high virus loads is likely involved~     in the pathogenesis of T cell dysfunction. The underlying hypothesis of the project is that~     the level of anti-viral immune dysfunction in chronic HCV infection is a causal factor which~     can influence non-response to therapy.~      Although the rate of response to direct anti-viral agent (DAA) therapy, in untreated,~     non-cirrhotic, patients is between 95% and 100%, however, the response rate is lower in~     specific subgroups of patients, including genotype 3 cirrhotics and patients with~     decompensated cirrhosis, irrespective of the infecting genotype.~      Aim of the present study will be thus to understand whether non-response to therapy is~     associated with a wider and deeper anti-viral immune dysfunction, by comparing individual~     HCV-specific T cell responses in two groups of responder and non-responder patients.~     Characterization of protective immunity in non-responder patients could allow to identify~     baseline predictors of non-response to therapy to be used in the daily clinical practice.~      Objective of the study will be to compare the features (intensity and quality) of the overall~     HCV-specific immune T cell response in patients non-responder and responder to DAA therapy.~     To achieve this goal, T lymphocytes (either CD4 or CD8) isolated from the peripheral blood of~     the patients, before starting DAA therapy, will be stimulated with HCV proteins to evaluate~     the capacity of those cells to expand, produce cytokines and express cytotoxic capacity.~   "
31473|NCT03155100|"~     The main aim of this study is to assess the ORR with a new drug combination, carfilzomib~     (CAR) + elotuzumab (ELO) + dexamethasone (CAR-ELO-Dex).~   "
31474|NCT03155087|"~     Metformin is a classical oral antidiabetic drug, often recommended to be the first-choice~     treatment of type 2 diabetes mellitus (T2DM). Based on the previous research on PRKAA2, STK11~     and diabetes, this study aimed to investigate the distributive characteristic of PRKAA2 and~     STK11 polymorphisms and the potential influence of STK11polymorphisms on metformin efficacy~     among Chinese T2DM patients, discuss the association of PRKAA2 polymorphisms between T2DM~     patients and healthy subjects.~   "
31475|NCT03155074|"~     The HILT study is a prospective, single-blinded, randomized controlled trial comparing a~     high-intensity exercise training intervention with usual care among adult lung transplant~     recipients. Patients randomized to the training intervention arm will undergo individually~     tailored high-intensity exercise training (80-95% of maximum heart rate) three hours per week~     for 20 weeks. Training will be conducted at local fitness centers on a one-on-one basis.~   "
31476|NCT03155061|"~     The objective of the study is to evaluate the safety, tolerability, pharmacokinetics,~     efficacy and biomarker of ONO-4578 and combinations of ONO-4578 and ONO-4538 in subjects with~     advanced or metastatic solid tumors.~   "
31477|NCT03155048|"~     In this prospective randomized trial, the parameters of the frozen-thawed embryo transfer~     (FET) cycles were analyzed. This study was undertaken in the Department of Assisted~     Reproductive Technologies and Reproductive Genetics Center at Istanbul Memorial Hospital with~     approval of the local ethics committee. The aim of this prospective randomized clinical trial~     was to compare two methods of endometrial preparation for FET, oral estradiol and estradiol~     transdermal patch.~   "
31478|NCT03155035|"~     Soil Transmitted Helminths (STH) are among the most common infections in the world today. The~     World Health Organization (WHO) recommends mass administration of deworming medicine as a~     single routine annual dose to all school age children (SAC)(age 5-16 years) in countries~     where prevalence of Soil Transmitted Helminthic Infections (STHI) is > 20% as a safe public~     health intervention that promotes healthy growth (Category 2 Recommendation). Pakistan is~     classified as a low burden community with a reported prevalence of STHI <50%, however,routine~     deworming is not a policy in Pakistan. Currently, Pakistan is also facing a huge burden of~     malnutrition in all age groups especially in population belonging to low socioeconomic group.~     Incidentally, worm infestation by STH also occurs in this group due to associated lack of~     hygiene and poor living conditions. The coexistence of even moderate STH infections can cause~     or aggravate malnutrition. The urban slums of Karachi provide environmental, social and~     behavioral conditions that favor both STH infections and a risk of under nutrition. It is~     unknown if administering routine dose of deworming medicine to SAC as per WHO recommendation~     will contribute to improvement in indicators of nutrition status in Pakistani children living~     in urban slum conditions by eliminating worm infection.Therefore, this study is being~     conducted to determine the effect of deworming on weight of School Age Children aged between~     5 to 16 years.~   "
31479|NCT03155022|"~     Infarct size is a major determinant of prognosis after AMI. Evidence indicates that the~     combination of intracoronary ischemic conditioning (ICIC) and remote ischemic conditioning~     (RIC) can significantly reduce infarct size in STEMI patients. Whether the combination of~     these two interventions may improve clinical outcome after STEMI remains unknown. The~     objective of the present study is to determine whether combination of ICIC and RIC can~     improve STEMI patients clinical outcome at 6 months.~   "
31480|NCT03155009|"~     This study will evaluate the efficacy and safety of alectinib, in selected participants, with~     anaplastic lymphoma kinase-rearranged (ALK-rearranged) non-small cell lung cancer (NSCLC),~     after disease progression on prior treatment strategy with crizotinib, as only ALK inhibitor,~     and eventually chemotherapy treatment(s).~   "
31481|NCT03154996|"~     The primary goal of this study is to establish, for the first time, safety of prolonged~     intracerebral convection enhanced delivery of chemotherapy in patients with recurrent high~     grade glioma (HGG). Secondary objectives will include determination of topotecan (TPT)~     distribution and radiographic tumor response with prolonged continuous intracerebral~     convection-enhanced delivery (CED).~   "
31482|NCT03154983|"~     The purpose of this study is to evaluate the efficacy and safety of Apatinib Mesylate Tablets~     combined with docetaxel and S-1 as the first-line treatment of metastatic gastric cancer.~   "
31483|NCT03154970|"~     This study will be performed in people with obstructive sleep apnea, in which one group will~     receive treatment with cervical stabilization for six weeks and the control group will~     receive treatment after the interval of six weeks~   "
31548|NCT03154125|"~     This is a randomized clinical trial designed to evaluate the effectiveness, safety and~     acceptability of Sayana® Press when injected every 4 months (17-18 weeks) for 3 treatment~     cycles (12 months) of use.~   "
31488|NCT03154905|"~     The digestive system may be involved in various pathologic conditions, with different~     inflammatory, metaplastic and neoplastic aspects. As the therapeutic tool-box for digestive~     diseases grows and becomes more focused, at times targeting specific molecules, decision~     making in managing patients becomes more and more important, and must be evidence based.~      Defining biomarkers with predictive value will theoretically allow physicians in making~     diagnosis, deciding on a suitable first line therapy (with specific endpoints suggesting~     response or indicating 2nd line therapy is indicated) and finally may suggest surgical~     intervention is warranted, thus forming an individually tailored treatment for each~     patient. These biomarkers may be located in the peripheral blood, in the gastrointestinal~     tract in general, or confined to specific intestinal lesions.~      Chitinase 3-like 1 protein (YKL-40) is produced by different tissues (e.g. - synovium, smooth~     muscle, intestinal epithelium). Its specific action is unknown, but several reports have~     described it in different inflammatory conditions including those involving the~     gastrointestinal system. Chitinase 3 like-1 protein (YKL-40) has also been studied for its~     possible role in angio and onco-genesis.~      This study aims to evaluate the diagnostic and prognostic value of peripheral and tissue~     Chitinase 3-like-1 (YKL 40) levels in gastrointestinal and liver diseases.~   "
31489|NCT03154892|"~     The neovascular glaucoma (NVG) is a refractory type of secondary glaucoma and often lead to~     frustrated treatment and blindness. It has been confirmed high levels of vascular endothelial~     growth factor (VEGF) in NVG. Conbercept is an anti-VEGF agent，its role in regression of other~     neovascular disorders such as wet-type age-related macular degeneration and diabetic~     retinopathy has been described. Investigators aim to evaluate the efficacy and safety of~     intracameral and intravitreal injection of conbercept for the treatment of NVG.~   "
31490|NCT03154879|"~     The investigators examine the prognostic value of continuous electroencephalography on~     frontal area of brain according to time by performing amplitude-integrated~     electroencephalography (aEEG) on cardiac arrest patients receiving therapeutic hypothermia.~   "
31491|NCT03154866|"~     The mode of delivery affects the diversity and colonization pattern of the gut microbiota~     during the first year of infants' life.~      Probiotics have been observed to positively influence the host's health, but to date few data~     about the ability of probiotics to modify the gut microbiota composition exist. 40 newborns~     born by elective caesarian sectional be randomized to a Lactobacillus kefiri LKF01 DSM32079~     (LKEF) supplementation or placebo for 21 days. Changes in the gut microbiota composition were~     detected by using a Next Generation Sequencing technology.~   "
31492|NCT03154853|"~     The purposes of these studies are to investigate:~      Differences in abductor hallucis muscles'EMG activities during different postural tasks~     between individuals with normal foot alignment and functional flat foot. Differences in~     abductor hallucis muscles'H-reflex amplitudes between individuals with normal foot alignment~     and functional flat foot. Changes in abductor hallucis muscles'EMG activities during~     different postural tasks after a 3-week short foot exercises training regimen in individuals~     with functional flat foot. Changes in abductor hallucis muscles'H-reflex amplitudes after a~     3-week short foot exercises training regimen in individuals with functional flat foot.~     hypotheses: Peak-to-peak amplitudes and ratios of abductor hallucis muscles and tibialis~     anterior muscles during different postural tasks were significantly lower in individual with~     functional flat foot when compared to those with normal foot alignments. H-reflex amplitudes~     of abductor hallucis muscles were significantly lower in individual with functional flat foot~     when compared to those with normal foot alignments. Changes of peak-to-peak amplitudes and~     ratios of abductor hallucis muscles and tibialis anterior muscles during different postural~     tasks were significantly different in individuals with functional flat foot after a 3-week~     short foot exercise training regimen. Changes of H-reflex amplitudes of abductor hallucis~     muscles were significantly different in individuals with functional flat foot after a 3-week~     short foot exercise training regimen~   "
31493|NCT03154840|"~     1. Compares and evaluates the relative bioavailability of single-dose subcutaneous~          administration of each of the Eutropin formulations to healthy male volunteers.~        2. Ensure safety and tolerability of single, subcutaneous administration of Eutropin~          formulations to healthy male volunteers.~   "
31494|NCT03154827|"~     This study will test the safety and effectiveness of a combination of investigational new~     drug called BL-8040 and atezolizumab to find out what effects, good or bad, this treatment~     has on medical condition. Atezolizumab is manufactured by Roche and is approved by FDA for~     other indications while BL-8040 is in late stages of clinical development. This is an~     investigational study. Approximately 60 patients will take part at multiple centers~     worldwide. It is an open-label study, which means that both subjects and the doctors will~     know which treatment you are receiving. All participants in the study will receive the~     investigational drug, BL-8040, both alone and in combination with atezolizumab. In other~     words, there will be no placebo (dummy drug).~      The duration of the treatment period of the study will be up to 2 years and will be followed~     by one year safety follow up. The study will consist of:~        -  a screening period of 21 days to allow your doctor to assess your suitability for~          enrollment into the study~        -  a treatment period of combination regimen of 21 day cycles for up to 2 years~        -  a follow-up period of up to 30 days after completion of combined treatment with BL-8040~          + Atezolizumab~        -  an additional follow up period for up to one year after the completion of the treatment~   "
31495|NCT03154814|"~     Retrospective study determine whether ulinastatin enhances postoperative pulmonary~     oxygenation after cardiopulmonary bypass (CPB).~   "
31496|NCT03154801|"~     This study aim to ensure that the implementation of a paramedical screening program and~     counseling in sexual health of patients with neurological pathologies (low-grade gliomas and~     Multiple Sclerosis) improves their sexual health.~   "
31497|NCT03154788|"~     The primary aim of this study is to develop and evaluate three short corporate falls risk~     awareness videos of approximately 1-2 minutes (each) by using the feedback from~     community-dwelling people aged 50 years and above. The three videos aim to make a broad~     audience aware of the risk of falling as one gets older.~   "
31498|NCT03154775|"~     This is a single arm, single-center, non-randomized study to evaluate the safety and efficacy~     of C-CAR011 therapy in relapsed or refractory B cell Non-Hodgkin Lymphoma (NHL).~   "
31499|NCT03154762|"~     INTRODUCTION: Asthma is a disease characterized by inflammation of the airway and secondary~     contraction of smooth muscle. Treatment for the crisis consist in the use of local and / or~     systemic bronchodilators and anti-inflammatories, and it has been shown that mechanical~     ventilation to the airway through non-invasive positive pressure ventilation (NIPPV)~     decreases bronchial hyperreactivity and contractility of smooth muscle.~      OBJECTIVES: To assess the effect of nocturnal NIPPV on local inflammation, systemic~     inflammation and the state of hypersensitivity in patients with asthma attack.~      MATERIALS AND METHODS: We will include patients with severe asthma attacks requiring~     hospitalization, without indication for acute NIPPV, and will be randomized to receive NIPPV~     with an spontaneous (S) bilevel or continuous positive airway pressure (CPAP, control group),~     all patients will receive standard treatment; gasometric exchange, local inflammation (FEV1~     and Exhaled fraction of nitric oxide), systemic inflammation (C reactive protein, IL-4, IL-5,~     IL-13 and IL-17 in peripheral blood) and the hypersensitivity state (eosinophilia and IgE)~     between both groups will be compared after 4 days of treatment.~   "
31500|NCT03154749|"~     Both TC (docetaxel/carboplatin) and EC followed by T (epirubicin/cyclophosphamide followed by~     docetaxe) regimens as Neoadjuvant Treatment for Triple-Negative Breast Cancer have been~     recommended by NCCN guideline. It is unknown which regimen is better. This study is to~     evaluate the efficacy and safety of TC (docetaxel/carboplatin) and EC followed by~     T(epirubicin/cyclophosphamide followed by docetaxe) regimens as Neoadjuvant Treatment in~     Triple-Negative breast cancer. The endpoint of pathologic complete response is used as a~     surrogate marker for survival. Safety and tolerability assessed by number of grade 4~     toxicities and hospitalizations.~   "
31501|NCT03154736|"~     Cardiovascular disease is the leading cause of death in the world. 17.5 million people died~     in 2012 due to a cerebrovascular disease (31% of all causes of death). In Europe more than~     50% of deaths are due to cardiovascular disease. The mortality rate for cardiovascular~     disease is higher in the lower socio-economic levels. Three-quarters of deaths from~     cardiovascular disease occur in developing countries. According to estimates in 2030,~     cardiovascular disease will be responsible for more deaths than the sum of infectious,~     nutritional, maternal and perinatal diseases in developing countries.~      Measures to prevent cardiovascular risk factors have been shown to be effective.~      The lack of an adequate primary care network in developing countries limits the screening and~     treatment of patients with cardiovascular risk factors. As a result, these patients do not~     benefit from adequate prevention, are diagnosed late and remain disabled or die at a young~     age, resulting in significant additional costs for families but also at the macroeconomic~     level.~      Interventions are possible on a large scale (policies against tobacco and adverse dietary~     behavior, promote physical activity, etc.). Actions are possible on an individual level, both~     in primary prevention (control of cardiovascular risk factors) and secondary prevention,~     where many treatments have proved their effectiveness. These interventions are effective and~     cost-effective from a macroeconomic perspective. It was estimated that the cost of such~     interventions would not exceed 4% of health expenditure in developing countries and 1-2% in~     rich countries.~      The World Health Organization insists on the importance of the triad composed by the patient~     and his family, community and health professionals. Results are possible only when these~     three components work together for the same purpose. Numerous studies show the benefit of the~     involvement of patients in their care in the rich countries and in the developing countries.~   "
31502|NCT03154723|"~     Retinopathy of prematurity (ROP) is a common retinal neovascular disorder and major cause of~     vision impairment or blindness, despite current treatment of late stage ROP. Because the~     visual disorders after treatment are often poor, preventive therapy for ROP is still lacking.~     Although ROP is a multifactorial disease, the altered regulation of vascular endothelial~     growth factor (VEGF) and insulin-like growth factor (IGF-1) have been implicated in the~     pathogenesis of ROP. Vitamin A is one of the most important micronutrients affecting the~     health of children. Supplementing newborn infants with vitamin A within the first 2 days of~     life reduced infant mortality by almost 25%, with the greatest benefit to those of low birth~     weight. Vitamin A has been used in this population prophylactically for chronic lung disease~     with the large doses and no reported significant adverse effect exists. It is suggested that~     vitamin A-retinoids and their active metabolite, retinoic acid (RA) have highly potent~     antiangiogenic activity by inhibiting VEGF expression. Vitamin A (retinol) is converted into~     retinoic acid in cells. However, the significance of Vitamin A administration has not been~     investigated to our knowledge in an experimental ROP infant. The aim of this study was to~     perform prospective, multicenter, randomized design to demonstrate the preventive effect of~     Vitamin A on ROP.~   "
31503|NCT03154710|"~     Lymphoma is the 6th cancer in terms of incidence in France where approximately 11,000 new~     cases are diagnosed each year. Most types of lymphomas occur at all ages with a predominance~     in elderly subjects.~      With the continuous improvement of the diagnostic techniques and the treatments, the~     prognosis of lymphomas is constantly improving. However, 20-40% of patients relapse most~     often within 2 or 3 years after the end of treatment.~      The current standard follow up includes a clinical examination and a biological check-up~     every 3 months for 2 years, then every 6 months up to 5 years and an imaging every 6 months.~     However, the interest of this systematic surveillance by imaging is controversial.~      The use of new information and communication technologies, can improve the clinical follow-up~     of patients. To date, access to the Internet and portable technologies is sufficiently broad~     and democratized to envisage the use of this type of remote surveillance in the field of~     health. In particular to facilitate the dissemination of information between the patient and~     the physician. It is thus possible to imagine using this flow of information to generate~     alerts.~      Strengthening the clinical follow-up in this indication, in which routine imaging has not~     demonstrated their interest, in particular by the implementation of remote monitoring~     completed by the patient, may present an advantage in terms of effectiveness and precocity of~     care. In this pathology, up to 40% of patients relapse early (within 2 to 3 years), in the~     vast majority of cases symptomatically (less than 2% asymptomatic relapse discovered by~     imaging). Finally the CT scan every 6-month , which generates radiation costs and exposures~     for a relatively low benefit, is performed in symptomatic patients since several weeks.~      The aim of this study is to evaluate the interest of a web-mediated follow up using a score~     based on the dynamics and the association of clinical and biological signs to alert the~     physician of a possible recurrence of the patients treated for a lymphoma in complete or~     partial response.~   "
31504|NCT03154697|"~     This database will be used to better understand the sleep problems of people with SMS. This~     clinical database will be a part of a larger Smith-Magenis Patient Registry used to create an~     awareness campaign around SMS and the sleep disturbances that are characteristic of the~     disorder.~   "
31505|NCT03154684|"~     The primary purpose of this study is to test if the STARK comprehensive autonomy health care~     package improves lower extremity function over time at 6 weeks, 3, 6 and 12 months after hip~     fracture compared to the standard of care.~   "
31506|NCT03154671|"~     A multicentre two-group parallel single-blind (outcome assessor) randomized controlled trial~     (RCT). A cost effectiveness study alongside a clinical trial using a payer and societal~     perspective to study the cost-effectiveness of geriatric assessment and management compared~     to usual care will be conducted.~      Participants allocated to the control group will receive usual oncology care. Participants~     allocated to the intervention group will receive a comprehensive geriatric assessment and~     management in addition to their usual oncology care. The intervention will take 6 months to~     be completed. Total study follow-up will be 12 months for each participant.~   "
31507|NCT03154658|"~     This is a randomized, interventional prospective study. Patients (n=66) undergoing~     mastectomies with or without tissue expander will be randomized to receive a supra-serratus~     or sub-serratus regional plane block prior to surgery. The main effect to be measured is~     total opioid consumption 24 hours after the operation. Secondary endpoints include measuring~     a change between pre-and post-operative pain scores, patient satisfaction of pain control~     during first 24 hours after the operation, presence of postoperative nausea and vomiting,~     duration of sleep on first postoperative night, and block performance time and length of~     stay, between the two treatment arms.~   "
31508|NCT03154645|"~     This double blind randomized trial will compare ibuprofen to acetazolamide for the prevention~     of acute mountain sickness. These drugs have never been directly compared for efficacy. The~     study population is hikers who are ascending at their own rate under their own power in a~     true hiking environment at the White Mountain Research Station, Owen Valley Lab (OVL) and~     Bancroft Station (BAR), Bancroft Peak, White Mountain, California.~   "
31509|NCT03154632|"~     The main objective:~      To compare the effect on muscle tone between the application of digital capacitive diathermy~     and the application of ultrasound on the myofascial trigger points (MTP) of the upper~     trapezius muscle.~      Hypothesis:~      The application of digital capacitive diathermy on myofascial trigger points of the trapezius~     muscle compared to the application of ultrasound produces objective changes in muscle tone,~     and this change is superior to the changes generated by the US.~   "
31510|NCT03154619|"~     The safety and efficacy of beta glucan products, and specifically TR 987, in the treatment of~     chronic venous insufficiency ulcers has been established. This study is designed to determine~     the most efficient method of treatment.~   "
31511|NCT03154606|"~     The investigators propose a randomized, tightly-controlled breakfast trial in normal to~     overweight adults that will test whether the consumption of various types of protein-rich~     meals, containing ~24g of protein, will differentially alter food intake and meal initiation~     through proposed appetite and satiety mechanisms.~      Aim 1: To examine whether the consumption of protein-rich meals that vary in protein quality~     (source) effect:~        1. postprandial feelings of hunger, fullness, desire to eat, prospective food consumption~        2. postprandial fluctuations in key appetite and satiety hormones~        3. eating initiation (i.e., motivation to eat (again))~        4. food cravings~      Aim 2: To examine whether the consumption of protein-rich meals that vary in protein quality~     (source) effect:~        1. energy intake and food choice within the breakfast meal~        2. energy intake and food choice at the next eating occasion~        3. energy intake and food choice across the entire day~   "
31512|NCT03154593|"~     Persistent swelling (chronic oedema), e.g. of the legs, is quite a common condition, which~     can cause a number of problems, including infections (cellulitis) in the swollen area and~     ulceration. It seems to be particularly common in people who are overweight but this has not~     been studied in detail. This study aims to address this gap in knowledge. It will take place~     in two stages, running in parallel to each other with different groups of patients. The first~     stage will determine how common persistent swelling is among patients attending weight~     management services at the Royal Derby Hospital and how it impacts on every day life. The~     second stage will determine whether weight loss surgery improves the swelling.~      The results will inform future treatment guidelines for overweight patients who have~     swelling. They will also inform the design of future research that will investigate the~     effects of weight loss surgery in more detail, for example by testing out methods of~     measuring fluid changes in the legs.~      All new patients attending the weight loss service will be eligible to take part in the first~     stage of the study, as long as they: give their informed consent to take part, and can speak~     English (or have someone with them who speaks English). Participants will not have had weight~     loss surgery previously. The Stage 1 assessment is expected to take about 40 minutes and~     consists of: a single clinical assessment for each participant to identify the presence of~     the swelling and its degree in each of the affected areas and, up to 3 questionnaires~     concerning their quality of life and mobility.~      Patients attending the programme, who have been referred for bariatric surgery, will take~     part in the second stage of the study. Stage 2 will last approximately 13 months, during~     which time the participants will be assessed 4 times - once before surgery and at 3, 6, and~     12-month intervals after surgery. Each Stage 2 assessment is expected to take about 50~     minutes and consists of: a clinical assessment and up to 5 questionnaires.~   "
31513|NCT03154580|"~     The purpose of the proposed study is to examine the relationship between marijuana reminders,~     or cues, craving for marijuana, and marijuana use. The principal investigator is also~     assessing whether N-acetylcysteine, can reduce marijuana craving or use.~   "
31514|NCT03154567|"~     The purpose of the proposed study to examine the links among stress, craving for marijuana,~     and marijuana reminders, or cues.~      In this study, an agent called yohimbine will be used to produce stress-like responses.~     Yohimbine is known to cause stress response in studies of alcohol and other substance use~     disorders. This study intends to show it can be used to cause stress in marijuana users as~     well.~   "
31515|NCT03154554|"~     Lumbar pain is an extremely common complaint in general population. The direct and indirect~     costs incurred in are a real public health problem.~      Cohort studies show that improving symptoms after consultation for lumbar pain is~     insufficient, but there are few data on emergency medical and surgical services in France. In~     order to reflect on areas for improvement the investigators to carry out an inventory of~     consultations for lumbar pain emergencies of Hautepierre Hospital.~   "
31516|NCT03154541|"~     Assess if the use of SYNRINSE can improve short-term subjective and objective outcome~     measures after one week in patients with active Chronic Rhinosinusitis (CRS) who have had~     prior sinus surgery.~   "
31517|NCT03154528|"~     Androgenetic alopecia is a common form of diffuse hair loss in both men and women,It~     primarily affects the top and front of the scalp with different clinical presentations and~     there are numerous classification systems for grading purposes.~   "
31518|NCT03154515|"~     The purpose of this study is to determine whether Ingavirin® 90 mg once daily is effective~     and safe for the treatment of influenza and other laboratory confirmed acute respiratory~     viral infections in the course of standard therapy in patients 18-60 years old.~   "
31519|NCT03154502|"~     This study is aim to determine the sodium intake in Ecuadorian population that is an unknown~     information at present. For that, 24h urine samples will be collected from 130 subjects~     working either at tue USFQ or HDLV to measure sodium excretion.~   "
31551|NCT03154086|"~     This FTIH study is designed to assess the safety, tolerability and pharmacokinetic (PK) of~     escalating single and repeat oral doses of GSK3352589 in normal healthy volunteers. This is a~     randomized, double-blind (sponsor unblinded), placebo controlled, dose escalation study that~     will have two parts; Part A and Part B. A total of 64 subjects will be randomized (8~     subjects/cohort) to GSK3352589 or matching placebo.~   "
31520|NCT03154489|"~     The interdisciplinary collaboration between doctors, nurses and pharmacists, can facilitate~     the control of patients under treatment with coumarin anticoagulants, increasing their safety~     and effectiveness. On the other hand, the clinical utility of tools such as pharmacogenetics~     and the SAME-TT2R2 is unexplored. Based on the foregoing, it seems necessary to study the~     impact of the Program of medication review with follow-up in collaboration with doctors and~     nurses in primary care improves the degree of control of the patients under treatment with~     coumarin anticoagulants. Method: a randomized, controlled study for the main objective.~     Population and scope of study: Patients on treatment with coumarin anticoagulants with time~     in therapeutic range (TTR) according to the method of Rosendaal less than 70% in follow-up~     from primary care in a health area of the Arrabal Health Center (Zaragoza, Spain). Each~     patient will be followed by a period of 6 months. After this period, patients in the control~     group (CG) will receive the service of medication review with follow-up for a period of time~     equivalent (6 months). Intervention: Program of pharmacotherapy follow-up. Variables result:~     Stability of the INR, drug adherence, intake of vitamin K, knowledge of the patient on the~     use of acenocoumarol, associated costs, avoided costs, quality of life, satisfaction of~     patients and professionals involved. Statistical analysis and sample size: 204 patients.~     Multivariate analysis will be used and cost-effectiveness..~   "
31521|NCT03154476|"~     The purpose of this study is to determine if the medication, sildenafil (also known as~     Revatio), can slow or stop the progression of liver disease in patients who previously had a~     Fontan operation.~   "
31522|NCT03154463|"~     This study aimed to compare the efficacy three-point Transversus Abdominis Plane (TAP) blocks~     with continuous epidural infusion for alleviating pain post-laparoscopic nephrectomy~   "
31523|NCT03154450|"~     Motor neurone disease is a progressive incurable disease causing weakness and paralysis of~     muscles. Respiratory failure is the most common cause of death in motor neurone disease.~     Patients with respiratory failure use a machine that supports breathing using a mask and~     ventilator (non-invasive ventilation: NIV) and using it for more than five hours per night~     has been shown to prolong life and improve symptoms such as poor sleep and breathlessness.~     NIV is however, challenging to use and some patients are unable to adhere to the required~     regime meaning they fail to gain benefit. Timely support is important to help individuals~     overcome early hurdles and barriers to using becoming regular NIV users.~      The Philips EncoreAnywhere is a system that allows continuous monitoring of the use and~     effectiveness of ventilation and allows instant adjustment of ventilator settings. The aim of~     this project is to explore if real time feedback and support, as well as remote changes to~     NIV settings using the EncoreAnywhere system could increase the number of individuals~     successfully using NIV. This project also aims to explore the impact of using EncoreAnywhere~     on the process of initiation of NIV, on both patients and staff.~      Patients starting NIV at the Sheffield MND care centre will be provided with the standard~     ventilator plus a Philips modem for the first three months of use. In half the patients~     clinicians will be able to use the EncoreAnywhere system to review patients' use of NIV, make~     adjustments and give feedback. In the other half, the data will be collected but not~     available to the clinical team. Clinical data will be collected as part of usual care:~     adherence, clinical encounters and resource use and patients will be asked to complete~     questionnaires at baseline, one month and three months. This will allow the care team to~     predict the potential impact on the service and on clinical care. This is a small pilot,~     feasibility study, and if the study is deemed feasible, a further larger randomized~     controlled trial is planned. The study will last for a maximum of 12 months, recruiting up to~     40 patients.~   "
31524|NCT03154437|"~     This open-label, multicenter expanded access program (EAP) is designed to provide emicizumab~     to eligible participants with hemophilia A with factor VIII (FVIII) inhibitors before it is~     commercially available in the United States for the indication of hemophilia A with FVIII~     inhibitors. Discontinuation may occur earlier if participant or physician decides to~     discontinue treatment or the sponsor discontinues emicizumab clinical development.~   "
31525|NCT03154424|"~     A single center, parallel group, prospective, randomized clinical trial was conducted at the~     department of Hand Surgery, ABC (Andre, Bernardo, Caetano) Foundation University Hospital,~     Santo Andre, Brazil. Two implants used for fixation in closed reduction of distal radius~     fractures were compared: the bridging dynamic Galaxy Wrist external fixator (Orthofix®,~     Verona) and the non-bridging Galaxy wrist external fixator system (Orthofix®, Verona).~   "
31526|NCT03154411|"~     The primary study objective is to determine if microdoses of ABY-029 (up to 6X) lead to~     detectable signals (defined as signal-to-noise ratio, SNR ≥10, with the Odyssey NIR scanner~     in sampled tissues with an EGFR pathology score ≥ 1 based on histological staining and~     compare SNR to tissues with an EGFR pathology score < 1).~      The secondary study objective is to assess if the spatial patterns of EGFR expression~     correlate with the tumor targeting of ABY-029 detection by NIR scanner relative to~     histopathology diagnosis, and other indicators (e.g. proliferation, infiltration, etc.) as~     the gold standard, and to measure the molecular uptake and concentration of ABY-029 in~     resected specimens.~   "
31527|NCT03154398|"~     Diabetes Mellitus is the most common disorder seen. The impact of this disease on the quality~     of life, and on morbidity and mortality through the complications that affect the small and~     large vessels resulting in retinopathy, nephropathy, neuropathy, and ischemic heart disease~     has been emphasized by the findings of the national commission (USA) on diabetes .~      So, there was curiosity to understand and learn the association of this disorder with another~     common endocrine gland function that is thyroid gland . The association between these two~     disorders has long been recognized although the prevalence of thyroid dysfunction in diabetic~     population varies widely between studies. With insulin and thyroid hormone being intimately~     involved in cellular metabolism and thus excess or deficit of these hormones result in~     functional derangement of the other .~      Diabetic patients have higher prevalence of thyroid disorder when compared with the normal~     population. Diabetic women are more frequently affected than men and hypothyroidism is more~     common than thyrotoxicosis.~      As Hyperthyroidism impairs glycemic control in diabetic subjects, while hypothyroidism may~     increase susceptibility to hypoglycemia thus complicating diabetes management so Severe~     diabetic complications where noted in patients with sub- clinical hypothyroidism .~     Sub-clinical hypothyroidism is an independent risk factor for development of diabetic~     nephropathy.~   "
31528|NCT03154385|"~     Previous studies have shown that increase level of BAFF could promote the settlement of~     long-lived plasma cells in the spleen of ITP patients treated with anti-CD20. This~     single-center prospective pilot study, currently in phase IIa, will evaluate the efficacy of~     a rituximab and belimumab sequential combination treatment. Investigators plan to include 15~     patients with persistent ITP over a 24-month inclusion period. Each patient will be followed~     for 1 year~   "
31595|NCT03153514|"~     The primary objective of the study is to evaluate the feasibility, efficacy and safety of an~     obinutuzumab containing conditioning regimen for poor risk CLL patients and patients with~     Richter`s transformation requiring an allogeneic stem cell transplantation.~   "
31529|NCT03154372|"~     Purpose:~      The aim of this study was to compare the effects of deliberate vs. self-guided practices on~     acquiring needling skills by novice learners.~      Methods:~      Eighteen medical students were randomized to deliberate or self-guided practices groups.~     Following a learning phase, subjects attempted to perform a predefined task, which entitled~     advancing a needle towards a target on a phantom gel under ultrasound guidance. Subsequently,~     all subjects practiced performing the task using previously validated metrics. Subjects in~     the deliberate practice group were coached by an expert anesthesiologist and practiced each~     metric until it was satisfactorily performed based on the supervising anesthesiologist~     assessment. Immediately after completing the practice, all subjects attempted to perform same~     task, and on the following day, made two further attempts in succession. Two trained~     consultant anesthesiologists will use the metrics to independently score the video-recorded~     performances.~   "
31530|NCT03154359|"~     The primary aims of this study focus on characterizing the relationship between atomoxetine~     exposure and clinical outcomes, as assessed by standardized measures. We will also~     simultaneously monitor side effect of atomoxetine, another measure of clinical outcomes, and~     categorize study participants on their ability to tolerate atomoxetine.~   "
31531|NCT03154346|"~     This study is the first initiative of Project Baseline, a broader effort designed to develop~     a well-defined reference, or baseline, of good health as well as a rich data platform that~     may be used to better understand the transition from health to disease and identify~     additional risk factors for disease. Project Baseline endeavors to test and develop new tools~     and technologies to collect, organize, and activate health information.~   "
31532|NCT03154333|"~     Epidermolysis bullosa simplex (EBS) is a rare genetic skin disease characterized by fragility~     of the skin and mucous membranes resulting in painful blisters and erosions after minor~     trauma. The simplex form is classified by skin blister development in the basal epidermis.~     Diacerein 1% Ointment is a topical ointment that is being developed for the treatment of EBS.~     Diacerein in the topical formulation is hydrolyzed to rhein in the epidermis and dermis~     following administration. Diacerein and rhein have been shown to inhibit the in vitro and in~     vivo production and activity of interleukin-1β (IL-1β) and other pro-inflammatory~     cytokines.The purpose of this study is to compare the efficacy of Diacerein 1% Ointment to~     Control Ointment when applied once-daily for 8 weeks in subjects with EBS.~   "
31533|NCT03154320|"~     This is a randomized, unblinded study comparing standard vs. same-day treatment for patients~     with TB symptoms (cough, fever, night sweats, or weight loss) at HIV diagnosis. Six hundred~     patients will be randomized in a 1:1 ratio to the standard group or the same-day treatment~     group. All study activities will take place at the GHESKIO Centers in Port-au-Prince, Haiti.~     The study population includes HIV-infected men and women ≥18 years of age who are ART-naïve,~     and who present with symptoms of TB (cough, fever, nights sweats, or weight loss >10%) at HIV~     diagnosis.~   "
31534|NCT03154307|"~     Perform non-invasive neuro-navigated repeated Transcranial Magnetic Stimulation (rTMS) at low~     frequencies (LF) with the intent to reduce the occurrence of seizures over time. Seizure~     reduction and improvements in the quality of life in patients with epilepsy will be~     associated with increased cortical inhibition resulting from the LF-rTMS sessions over time.~     This procedure using rTMS at low frequencies (LF-rTMS) between 0.5 and 1 Hz is a safe and~     painless method for noninvasive focal cortical brain stimulation, which will be evaluated in~     its efficacy at reducing/suppressing seizures. Accordingly, we propose a clinical trial in~     patients with epilepsy to test whether LF-rTMS can improve seizure suppression. The location~     of the presumed 3D source in the brain will be stimulated for few minutes (10 to 15 min.).~     With the same rTMS modality, we will also perform motor threshold mapping in conjunction with~     its fully integrated and compatible electroencephalography (EEG) module. Up to 100~     individuals 18 to 80 years with epilepsy will be enrolled.~   "
31535|NCT03154294|"~     This is an open-label, cohort study to determine the feasibility and tolerability of the~     combination of TAK-228 and TAK-117 given on days 2-4, 9-11, 16-18, and 23-25 with paclitaxel~     on days 1, 8, and 15 for one 28-day cycle in patients with advanced solid tumors.~   "
31536|NCT03154281|"~     Open-label, cohort study to determine the feasibility and tolerability of the combination of~     daily niraparib and daily or thrice weekly everolimus for one 28-day cycle in patients with~     advanced ovarian and breast cancer.~   "
31537|NCT03154268|"~     The purpose of this study is to investigate the reference ranges and rates of gestational~     weight gain among Chinese pregnant women, and to analyze the correlation between gestational~     weight gain and adverse outcomes.~   "
31538|NCT03154255|"~     Alongside efforts in public health and policy to reverse the childhood obesity epidemic,~     medical providers seek to play effective roles in prevention and treatment. Limited~     interventional studies with effective long-term maintenance of weight loss in children are~     available. Moreover, interventions should focus on modifying lifestyle, by improving also~     ludic educational training. In fact, the knowledge, attitudes, behaviors and skills developed~     through effective health programs may result in a better quality of life and empower children~     to make correct choices to promote the health of the individual the family and the community.~     For this reason, in a cohort of obese pediatric subjects with visceral adiposity, the aim of~     the study is to assess the efficacy of an educational training inspired to Mediterranean diet~     and based on gamification (as The Mediterranean Goose) with respect to a conventional~     treatment on weight loss and improvement of cardio-metabolic risk factors.~   "
31539|NCT03154242|"~     This Study evaluate the effect of Polymorphism in the Excision repair cross-complementing~     group 5 (ERCC5) (rs1047768 and rs751402) gene on the clinical outcome of Platinum-based~     regimens used in the treatment of Non-Small Cell Lung Cancer (NSCLC) patients~   "
31549|NCT03154112|"~     The measurement of how much oxygen a baby consumes provides important information about the~     health of the baby, and of how much energy they are consuming. Currently, there is no device~     which measures either oxygen consumption, or another variable that depends on oxygen~     consumption - resting energy expenditure - in neonates or infants. Our group has developed a~     new device which can attach to any ventilator and measures these two variables with accuracy~     in the preclinical setting, including in rodents as small as severely preterm infants. The~     purpose of this study is to compare measurements of oxygen consumption and energy expenditure~     in neonates using this device and comparing it with a gold standard which is rarely used, a~     Douglas bag method in which expired gas is collected and later analyzed.~   "
31540|NCT03154229|"~     The study hypothesis is that clinical decision-support on a smartphone for the management of~     diarrheal disease will improve the assessment of dehydration, reduce IV fluid usage, and~     increase guideline adherence for the use of zinc and antibiotics. To test this hypothesis we~     will conduct a cluster randomized controlled trial in the diarrhea wards of 10 hospitals in~     Bangladesh. A 6-week pre-intervention period will establish a baseline at all sites, and in~     the intervention, hospitals will be randomized to use a paper versus smartphone adaptation of~     the WHO guidelines by the admitting physician. Inclusion criteria are patients 2 months and~     older that have uncomplicated acute diarrheal disease; estimated enrollment is 7893 patients.~     The primary outcome measure is use of IV fluids. This project may have broad impact that will~     include opportunities to provide improved decision-support for the assessment of dehydration,~     decreased use intravenous fluids and more prudent use of antibiotics.~   "
31541|NCT03154216|"~     Fasting blood fat levels (triglycerides) are often used to assess risk of heart disease but~     the level of fats in the blood after a meal is actually a stronger risk factor. Most of our~     day is spent digesting the food we eat (which takes hours). Therefore, after meal blood fat~     levels have more of an impact on formation of blockages in our arteries and our risk of heart~     disease compared to fasting blood fat levels. Exercise performed hours before a meal~     reduces the level of fats that appear in the blood after a meal and can be used to reduce our~     risk of heart disease. Exercise has this effect because muscle burns fats for hours after an~     exercise session is over; this helps to remove fats from the blood. Unfortunately, when~     high-sugar drinks (such as Gatorade) are consumed after exercise, the possible benefits of~     exercise for reducing blood fat levels after meals is lessened. This is because high-sugar~     drinks stimulate the release of insulin into the blood. Insulin is a hormone which inhibits~     fat burning at the muscle. Previous research we did showed that foods that result in a slower~     rise in blood sugar and lower release of insulin preserve the beneficial effects of exercise~     for lowering blood fat levels after the next meal. Milk also results in a slow rise in blood~     sugar and low release of insulin; therefore, it may also have this beneficial effect if~     consumed as a recovery beverage after exercise. Our proposed research will test the effects~     of consuming two popular exercise-recovery drinks (Milk vs. Gatorade) on the rise in blood~     fat levels after a meal given hours later. A total of 20 obese or overweight participants~     will take part. We predict that milk consumed after an exercise session in the evening will~     result in a lower increase in insulin, a greater amount of fat-burning at muscle and a lower~     blood fat level after a meal given the next morning. Milk and Gatorade are both promoted as~     good beverages to promote recovery after exercise. This study will provide evidence about~     milk as a healthier choice compared to Gatorade and will allow dairy producers to promote~     health benefits of dairy products.~   "
31542|NCT03154203|"~     This study is a sub-investigation of SAFAR study. Consecutive patients with established~     hypertension (treated or untreated with antihypertensive drugs) or with suspected~     hypertension are recruited and their 24-hour brachial and aortic blood pressures,~     cardiovascular risk factors and target organ damage are assessed. And the participants'~     target organ damage, cardiovascular events, cardiovascular and overall mortality will be~     followed four years later.~   "
31543|NCT03154190|"~     This randomized pilot clinical trial studies health care coach support in reducing acute care~     use and cost in patients with cancer. Health care coach support may help cancer patients to~     make decisions about their care that matches what is important to them with symptom~     management.~   "
31544|NCT03154177|"~     The focus of this work is to improve antenatal care (ANC) and postnatal care (PNC) at the~     health center level in five districts in Rwanda (Bugesera, Burera, Nyamasheke, Nyarugenge,~     and Rubavu). 36 health centers in these districts are included in this cluster randomized~     control trial (RCT) of group ANC and PNC care to measure this alternative model's effects on~     gestational age at birth, survival of preterm and low birth weight infants at 42 days of~     life, and ANC and PNC coverage. To improve antenatal assessment of gestational age, nurses~     will be trained in obstetric ultrasound at 18 health centers. These facilities will also~     incorporate pregnancy testing with urine dipstick to be performed by community health workers~     in charge of maternal health to facilitate early entry into ANC. This trial will test the~     hypothesis that women who participate in this alternative model of group ANC will experience~     increased gestational age at birth, as compared to women who receive standard focused ANC.~     This study is a collaboration with the University of Rwanda, the Rwandan Ministry of Health~     (MOH), the Rwanda Biomedical Center, and UCSF.~      The group care model used in this study is Rwanda-specific model developed by a Rwandan~     technical working group. The model includes an individual clinical visit for the first~     antenatal visit, followed by three group visits spaced about 8 weeks apart throughout~     pregnancy and a postnatal group visit at approximately 6 weeks after birth. Women will be~     grouped into stable groups of approximately 8-12 women with similar due dates. A community~     health worker (CHW) and a health center nurse will work together as co-facilitators to lead~     each of the groups. Each group visit includes clinical assessment, education, and treatments~     as appropriate for the women who attend. The model is founded on facilitative leadership of~     the groups, in which the co-facilitators allow women's experiences and interests to drive the~     content and women are encouraged to help one another cope with obstacles to optimal health.~     Facilitators will be supported by master trainers who will visit health centers to observe~     group sessions and offer supportive feedback.~      Data collected in this trial will include measures of the satisfaction of both women and~     providers with the group care, content of care differences between standard and group care,~     and perinatal outcomes such as gestational age at delivery and 42-day preterm and low birth~     weight infant survival.~   "
31545|NCT03154164|"~     The present study aims at analyzing the learning curve for fundus first with the ultrasonic~     tissue coagulation dissection technique in elective cholecystectomy. Patients included in the~     study are planned for an elective cholecystectomy, on the basis of the gallstone disease. All~     participating surgeons have experience of the traditional approach with electrocautery. The~     operation time as well as the surgeons own evaluation of difficulty and performance are~     noted. Selected films are analyzed by independent surgeons with experience of the fundus~     first technique. The Swedish registry of gallstone surgery and ERCP (GallRiks) are used to~     record the intra and postoperative complication rate.~   "
31546|NCT03154151|"~     If you worked or volunteered as a WTC rescue, recovery or clean-up worker after the 9/11~     attacks, and you are still experiencing Posttraumatic Stress Disorder (PTSD) symptoms related~     to your WTC experience, you might be eligible to participate in this clinical trial of~     therapist-assisted, Internet-based (online) writing therapy for WTC responders with~     persistent PTSD symptoms. This study is for WTC responders who are not currently receiving~     psychotherapy/counseling, and who are not currently taking prescription medication for a~     psychiatric or emotional problem. In this study, the researchers aim to find out if~     Internet-based therapy can help WTC responders who are still experiencing PTSD symptoms.~   "
31547|NCT03154138|"~     Postural imbalance after stroke leads to limitations of activity and a worse autonomy. The~     postural imbalance is increased in right supratensorial stroke (RSS) compared to left~     supratensorial stroke. The evidences for the rehabilitation of postural imbalance are weak.~      Likewise, disorders of spatial reference frames are increased in RSS. The postural imbalance~     is correlated with the disorders of spatial reference frames in RSS patients.~      Prismatic adaptation (PA) is often used for the rehabilitation of unilateral spatial neglect~     after RSS. Several studies have demonstrated a peculiar expansion of sensorimotor~     after-effects to spatial cognition. An immediate effect of reduction in postural imbalance~     have been showed in acute RSS. Therefore, it is interested to investigate the immediate and~     delayed effects of PA on the postural balance and the spatial reference frames in chronic RSS~     to purpose a new therapeutic approach.~      The hypothesis of the study is that PA would improve the postural balance (activity) of~     chronic RSS patients by a reduction in mediolateral postural asymmetry, resulting from a ~     bottom-up  action of PA on spatial reference frames.~   "
31552|NCT03154073|"~     The purpose of this study is to compare the effects of moderate versus vigorous intensity~     exercise training on glycemic control in older adults. Glycemic control will be assessed~     using an oral glucose tolerance test and continuous glucose monitors. In addition, the~     investigaotrs will investigate whether engaging in an exercise training program elicits~     changes in sedentary behavior, non-exercise physical activity, sleep, and total daily energy~     expenditure.~   "
31553|NCT03154060|"~     On the first of July 2016, reimbursement for the Freestyle Libre Flash Glucose Monitoring~     (FGM) was introduced by the Belgian healthcare authority by means of a new diabetes~     convention. Making this the only way to receive the device in Belgium. Since then, many type~     1 diabetes (T1D) patients switched to FGM. But some patients found the sensor on the upper~     arm too visible. Abbott does not recommend to place the sensor on a different place of the~     body than the back of the upper arm, because no tests were done yet (besides on the upper~     arm) to make an accuracy claim. With this study, we want to evaluate the accuracy and the~     precision of the Freestyle Libre FGM by using three FGM sensors simultaneously on different~     places of the body and perform regular self-monitoring of blood glucose (SMBG) tests.~   "
31554|NCT03154047|"~     The objective of this study is to evaluate the long-term safety and efficacy of NEOD001 in~     subjects with AL amyloidosis who have completed Study NEOD001-201.~   "
31555|NCT03154034|"~     The purpose of this study is the evaluation of cardiac and pulmonary response to~     cardiopulmonary exercise in severe mitral regurgitation and its variation under treatment~     (surgical mitral valve repair, percutaneous mitral valve repair, optimal medical treatment).~     The study is conducted as a prospective, observational, single-center study. Patients~     suffering from symptomatic severe mitral regurgitation will be eligible, if they are referred~     to the University Hospital of Regensburg, Germany, for further diagnostic procedures and~     heart team discussion. Cardiopulmonary exercise testing is performed comprising standardized~     stress echocardiography as well as ergospirometry. Additional detailed assessment will be~     conducted including standardized questionary, clinical examination, transesophageal~     echocardiography and measurement of biomarkers.~   "
31556|NCT03154021|"~     To assess the effect of a test antimicrobial oral rinse from Next Science on the prevention~     of oral biofilm formation and thereby preventing gingivitis by monitoring the oral microbial~     flora and measuring gingival inflammation and bleeding.~   "
31557|NCT03154008|"~     The current study will examine neurophysiological, specifically event-related potential~     (ERP), measures of emotional processing as predictors of response to cognitive behavior~     therapy for adolescent depression.~   "
31558|NCT03153995|"~     The objective of my study will be to assess and compare between two different approaches for~     placement of self- inflating osmotic tissue expanders used as preparatory surgery before~     alveolar ridge augmentation using autogenous onlay block bone graft.~      The assessment and comparison will be based on:~        1. Change in edentulous alveolar ridge in bucco-lingual dimension after alveolar~           ridge augmentation.~        2. Quantity of the soft tissue obtained after soft tissue expansion.~   "
31559|NCT03153982|"~     The purpose of this study is to assess the safety and efficacy of ruxolitinib in patients~     with operable Head and neck squamous cell carcinoma (HNSCC) who are planned for definitive~     surgery.~   "
31560|NCT03153969|"~     The objective of this study is to evaluate the clinical effectiveness of a new composite~     resin (SHOFU Beautifil II LS) vs a control (3M/ESPE Filtek Supreme) for use in restoring non~     carious cervical lesions Class V lesions.~      3M ESPE FiltekTM Supreme is one of the composite resin materials that will be used in this~     study (Group 1). This is a light-activated, flowable restorative composite.~      Shofu Beautifil II LS (SI R21204) is a new type of filling material called a Giomer. This is~     the second composite that will be used in this study (Group 2) Giomer is a collective term~     for dental materials that will release ions, such as fluoride. Results from previous studies~     show that the released ions may have beneficial effects on the tooth, including strengthening~     the tooth.~      In each participant, one tooth with a class V lesion will be randomized to group 1, and a~     second tooth with a class V lesion will be randomized to group 2. The restorations will be~     observed over 18 months to determine clinical acceptability.~   "
31561|NCT03153956|"~     A prospective, interventional, randomized, double-arm clinical evaluation study to examine~     the efficacy of AposTherapy® versus a control group, in the short-term at 6 months and in the~     long-term at 12 months post-treatment, with the primary efficacy assessment based on~     improvement in knee pain score and improvement in function in patients following diagnosis of~     knee osteoarthritis (OA).~   "
31562|NCT03153943|"~     Approximately 30,000 adults in Quebec over the age of 50 suffer a fragility fracture each~     year. Fractures can affect a person's health, well-being and autonomy. Personal costs of~     these fractures are high, with as many as 50% of hip fracture patients being unable to return~     their pre-fracture level of autonomy.~      Homecare and community services provide customary rehabilitation support immediately~     following discharge from acute-care, though this contribution can be limited by lack of~     resources. For those patients at risk of negative outcomes, we have demonstrated clinically~     important benefits of extended exercise rehabilitation programs offered beyond the regular~     rehabilitation period on improving physical function.~      Through advances in sensor and telecommunication technology, eHealth solutions incorporated~     within homecare services as an integral part of the continuum of care can lead to better~     patient and health professional experience, improve clinical outcomes and reduce costs to the~     healthcare system.~      The purpose of this study is to determine if the implementation of a 4-month community-based~     extended-rehabilitation e-Monitoring and Coaching support program is more effective at~     improving mobility in community-dwelling elderly patients who have sustained a fracture than~     a printed material support program, and if these effects persist 6 months after~     discontinuation.~   "
31596|NCT03153501|"~     Image-guided pleural biopsies, both ultrasound (US) or computed tomography (CT) guided, and~     medical thoracoscopy are important in the diagnosis of pleural disease. However, no consensus~     exists regarding which biopsy methods are appropriate for specific procedures.~      In this prospective study, the investigators aimed to compare CT-scan guided pleural biopsy~     using an Abrams' needle (CT-ANPB) with US-assisted pleural biopsy using a cutting needle~     (US-CNPB)and medical thoracoscopy with respect to both diagnostic yield and safety.~   "
31563|NCT03153930|"~     This study is a randomized crossover trial to compare the effectiveness of interrupting SB on~     glucose homeostasis in the lab and free-living settings. All participants (N=56) will~     complete one screening visit to determine eligibility, complete at fitness test, and body~     composition analysis by bioelectrical impedance. After 7-21 days, all participants will~     complete two 3-hour in-lab oral glucose tolerance tests (spaced 7-21 days apart). Prior to~     the in-lab OGTT visits, participants will wear an activity monitor for 7 days on the right~     thigh. The experimental conditions for the OGTTs will be: 1) 3-hour OGTT of continuous~     sitting; and 2) 3-hour OGTT with sitting interrupted every 30 minutes with 3-minutes of~     moderate intensity walking on a treadmill. There will be a 7-21 day washout period between~     the OGTT visits. In addition, a subset of participants (N=12) who meet inclusion criteria and~     who successfully complete both OGTT visits will complete a second randomized crossover trial~     in the free-living environment. The experimental conditions for the free-living components~     will be: 1) 4 days of habitual sedentary behaviors; and 2) 4 days of prompted short exercise~     breaks during times in which sedentary behaviors have exceeded 30 minutes. Participants in~     the free-living trial will wear an activity monitor and a continuous glucose monitor.~   "
31564|NCT03153917|"~     Nonstandard time-schedules work are widespread in the world of work. Shift and night work~     have been shown to be responsible for a desynchronization of biological rhythms, associated~     with melatonin secretion impairment and sleep disturbances. However, while health~     consequences of night and shift work are widely recognized and represent a major public~     health concern (High Authority of Health 2012 Recommendations and National Agency for Public~     Health Food, Environment and Work 2016 Report), the mechanisms by which the circadian system~     is affected by shift work remain poorly understood. Indeed most of the studies in the fields~     are cross-sectional, based on few blood or urinary samples in a single work position, in~     workers whose shift work patterns are often misidentified and heterogeneous. Moreover, few~     studies have assessed melatonin secretion alterations in relation to objective sleep~     measurement (actigraphy). The aim of this study is to assess the dynamics of melatonin~     secretion adaptation in 12-hour shift work and to correlate these data to sleep-wake cycle~     recording.~   "
31565|NCT03153904|"~     Connecticut Child STEPS is a randomized controlled trail investigating the effectiveness of~     MATCH-ADTC in treating anxiety, depression, trauma, and/or behavioral problems in children~     seeking services at four Department of Children and Families (DCF) funded clinics in the~     state of Connecticut. The study will evaluate child outcomes following two forms of therapist~     training in the MATCH model.~   "
31566|NCT03153891|"~     This randomized controlled trial examines the effect of nature exposure on pain intensity~     levels among older adults who experience chronic pain. Investigators examine the effects of~     nature on: the experience of chronic pain, on pain catastrophizing, and on attention~     restoration.~   "
31567|NCT03153878|"~     This is a registry study of the natural course of unruptured intracranial aneurysms (UIA). In~     addition, the investigators will analyze the benefit-risk of antithrombotic or anticoagulant~     therapy in patients with unruptured intracranial aneurysms associated with ischemic heart~     disease or ischemic cerebrovascular disease. The investigators aim to use research data to~     create a China national database of UIA~   "
31568|NCT03153865|"~     This is a prospective, multicenter, observational study, aiming at comparing the Safety and~     effectiveness among the different surgical treatment of unruptured intracranial aneurysms in~     China, so as to improve the diagnosis and treatment of unruptured intracranial aneurysms.~   "
31569|NCT03153852|"~     Melasma is a common acquired disorder of hyperpigmentation characterized by irregular light~     brown to dark brown patches of hyperpigmentation commonly affecting the face. The trunk and~     arms are also occasionally involved .~   "
31570|NCT03153839|"~     Introduction: physical activity in infants through aquatic therapy is widely known for the~     later development of sensory ,cognitive and motor areas. In this way, babies will have a~     greater sense of freedom, pleasure and memory of the maternal uterus. In addition, the margin~     therapeutic safety in the water is very broad, which allows an optimal development of aquatic~     early stimulation programs.~      Objective: To determine the relationship between aquatic physical activity in infants and the~     development of their psychomotor skills in their first year.~      Methods: A prospective case-control study will take place for 12 months. Participating~     infants will be divided in two groups: an experimental group, which will be integrated by 74~     babies who will participate with their parents in the aquatic physical activity programme in~     a heated pool (34-35ºC) and a control group with 71 babies who will not participate in the~     activities. The aquatic activity will consist on 20 minutes sessions twice a week.~   "
31571|NCT03153826|"~     Chronic Obstructive Pulmonary Disease (COPD) is characterized by persistent airway~     obstruction and inflammatory response of the lungs and bronchi. Episodes of exacerbations~     contribute to increase the severity and prognosis of the disease. Muscle dysfunction (loss of~     strength and muscle mass) is one of comorbidities affecting 30% to 60% of patients and~     playing a key role in their prognosis. Indeed, several studies have shown muscle weakness~     during hospitalization for exacerbation of COPD by measure of maximal voluntary contraction~     of quadriceps (MVCQ), but the results are variable from one patient to another. Moreover, no~     study was interested in the change of muscle mass in patients hospitalized for an~     exacerbation of COPD. Several mechanisms have been mentioned but not demonstrated: systemics~     factors (initial amyotrophy, inflammation, oxidative stress, corticotherapy, hypoxia…) but~     also physical inactivity. In this context, identifying factors associated with the onset of~     muscle weakness during hospitalization for exacerbation of COPD is a necessary step to better~     understand the mechanisms and consider a personalized therapeutic approach that can improve~     the functional and clinical prognosis of disease.~      The primary outcome is to identify the clinical and biological determinants associated with~     the onset of amyotrophy (Measure by ultrasound of sectional area of the Rectus Femoris,~     CSARF), during hospitalization for exacerbation of COPD. The secondary outcome is to identify~     the clinical and biological determinants associated with the onset of MVCQ decrease, during~     hospitalization for exacerbation of COPD.~      120 patients hospitalized for exacerbation of COPD will be recruited in two hospitals (CHU~     Montpellier - CHU Grenoble, FRANCE). The measures of CSARF and MVCQ are carried out on the~     second, fifth, eighth day of hospitalization, on discharge and on the sixtieth day after~     hospitalization. A blood test will be performed on the second day of hospitalization to~     explore different markers of inflammation and oxydative stress. Moreover, to quantify the~     level of physical activity (number of steps), each patient will carry a pedometer throughout~     the duration of hospitalization.~      At the end of protocol, two groups will be made from the median of CSARF : patients with a~     small reduction in CSARF compared to patients with a greater reduction in SSRF between the~     second and eighth days of hospitalization (or between the second day of hospitalization and~     discharge). Then clinical (comorbidities, severity disease, initial weakness, initial~     amyotrophy, usual physical activity before hospitalization, treatment, exacerbation number in~     the previous year…) and biological (markers of inflammation and oxydative stress)~     determinants were compared between the two groups.~      Thus, the identification of the determinants associated with the onset of amyotrophy induced~     during exacerbation of COPD will guide research for exploration of physiopathological~     mechanisms of this muscular dysfunction in the exacerbation of COPD as well as to identify a~     personalized support.~   "
31572|NCT03153813|"~     To assess the efficacy and safety of high concentration capsaicin patches in pain due to~     osteoarthritis (OA) of the knee in patients with obesity~   "
31624|NCT03153137|"~     The primary objective is to assess the effect of macitentan 10 mg as compared to placebo on~     exercise capacity through cardiopulmonary exercise testing.~   "
31573|NCT03153800|"~     Chronic respiratory diseases including chronic obstructive pulmonary disease (COPD),~     bronchiectasis (BE) or pulmonary fibrosis (PF) are usually not curable with damaged pulmonary~     structure and function. Bronchial basal cells are proved to regenerate bronchus and alveoli~     to repair the pulmonary injuries. In this study, we intend to perform an open, single-armed~     phase I clinical trial by transplantation of autologous bronchial basal cells on patients~     suffered from COPD, BE or PF. During the treatment, autologous bronchial basal cells, which~     were isolated from fiberoptic bronchoscopy and expanded in vitro, will be injected directly~     into lesions by fiberoptic bronchoscopy after careful characterization. In the following 6~     months, the safety and efficacy of the treatment will be monitored by measuring the key~     clinical indicators.~   "
31574|NCT03153787|"~     The objective of the present study to analyze the vaginal microbiome in patients who have not~     achieved gestation after oocyte donation treatment and after probiotic administration.~      All patients will receive vaginal probiotic according to the standard regimen. Sample~     collection will be performed the embryo transfer day and on the day of the pregnancy test.~     Follow up of gestation will be carried out.~      The analysis of the vaginal microbiome will be performed though massive genetic sequencing~     (determination of 16SRNA).~      The study variables, among others, are vaginal microbiome pattern after probiotic~     administration, the gestation rate, and the abortion rate.~   "
31575|NCT03153774|"~     The main objective was to assess the prevalence of sarcopenia in chronic heart failure~     patients and in patients before the trans aortic valvular implantation.~      The loss of muscle mass in chronic heart failure patients is a prognostic factor for~     sarcopenia. The purpose was to identify in these patients signs of sarcopenia for a better~     management.~   "
31576|NCT03153761|"~     This study will evaluate exposure to tobacco constituents from two moist snuff products, and~     provide a basis for comparing mouth-level exposure (MLE) in moist snuff users after use of~     each of the two moist snuff products.~   "
31577|NCT03153748|"~     This study aims at clarifying the current situation of Emergency treatment of aneurysmal~     subarachnoid hemorrhage (SAH) in China, and analyzing the safety and efficacy of the~     treatment strategy between interventional treatment and open surgery, so as to improve the~     diagnosis and treatment of aneurysmal SAH.~   "
31578|NCT03153735|"~     The investigators aimed to confirm the efficacy and safety of transdermal penis enlargement~     for 24 weeks after CMDHA0101 injection in subjects who wanted penile enlargement in male~     patients with small-penis syndrome *.~      *Small-penis syndrome is the anxiety of thinking one's penis is too small - even though it~     isn't.~   "
31579|NCT03153722|"~     This study will utilize an iterative quality improvement process to identify and address~     delays in the pediatric hospital discharge process.~   "
31580|NCT03153709|"~     The purpose of this study is to compare the pregnancy rates among women who are using the HIV~     drug Efavirenz and either the birth control injection or implant.~   "
31581|NCT03153696|"~     The purpose of this study is to assess the feasibility (fidelity, acceptability,~     implementation, cost) of the Cellie Coping Kit for Children with Injury as well as to~     determine the intervention's efficacy (mechanisms of action and health outcomes).~   "
31582|NCT03153683|"~     This is a prospective open enrollment registry to evaluate arterial blood and thrombus~     removed during the standard thrombectomy procedure, which will then be used for the purposes~     of identifying biological markers, inflammatory cell infiltrates, and biological states in~     large vessel occlusive stroke in the human condition. The primary objectives are to evaluate~     the feasibility of obtaining distal clot blood during thrombectomy; develop a group of~     biosamples (blood and clots) to evaluate novel proteins, cell types, and cytokines in acute~     ischemic stroke in the human condition, and evaluate specific biomarkers, proteins, and~     leukocyte populations in stroke in the human condition. The study population will include up~     to 250 subjects. Male and female participants 18 years of age and older will be enrolled.~     Participants must have had a suspected acute ischemic stroke based on clinical and~     radiographic evidence as determined and documented by the Stroke Neurology team at University~     of Kentucky. There is no therapeutic intervention involved in this study.~      This is the first study to our knowledge that will utilize thrombectomy technique to collect~     focal blood samples and the clot related brain infarction. This proposal will provide~     preliminary data needed to understand relationships between the local inflammatory cascade~     and clinical variables such as age, gender, time from symptoms to thrombectomy, and stroke~     imaging results. Characterizing these relationships is vital in the formulation of related~     therapeutics. Issues of gender-differences, age-based variations, and co-morbidities all~     engender heterogeneity, which plague translation of stroke research from animal to human. By~     starting with the human condition, the investigators aim to minimize this loss in~     translation. Overall, this study will have a great impact on our knowledge of stroke~     pathology. In essence, this could fundamentally change not only how the investigators develop~     treatment strategies for the stroke patient population but allow us to individualize the~     treatment dependent on time after stroke, age, sex, and co-morbidities. Molecular techniques~     that are impractical when delivered systemically could be delivered locally to impede the~     early inflammation.~   "
31583|NCT03153670|"~     Deep brain stimulation (DBS) is an established treatment for advanced Parkinson's disease,~     medically refractory tremor, dystonia and obsessive compulsive disorder. Several hypotheses~     driven DBS trials are underway to study modulation of circuit dysfunction in other~     neurological and psychiatric disorders like epilepsy, Alzheimer's disease and depression.~     Recent reports suggest profound effects of DBS on the anatomy and function of downstream~     areas in the brain. For example electrical stimulation of limbic circuits is associated with~     increase in hippocampal neurogenesis. Similarly, stimulation of subthalamic nucleus (STN) or~     globus pallidus (GPi) results in activation of cortical motor circuits. Non-invasive imaging~     modalities are increasingly being employed in these investigations to better understand the~     effects of DBS on the structure and function of the brain.~      There have been important advances in MRI and we now have MRI which provides higher~     resolution and higher quality brain images. More specifically, the investigators propose to~     use MRI to perform functional magnetic resonance imaging (i.e. fMRI) to assess the effects of~     deep brain stimulation on brain function.~   "
31593|NCT03153540|"~     Nonfluent/agrammatic variant primary progressive aphasia (nf/avPPA) is a fatal~     neurodegenerative disease that begins with isolated language deficits. There is currently no~     cure or treatment for this disease. Repetitive Transcranial Magnetic Stimulation (rTMS), a~     noninvasive neuromodulatory technique, is effective in major depression, and studied in many~     other conditions including nf/avPPA. Here the investigators propose to study the feasibility~     and change in language and brain function of a newer rTMS protocol (intermittent theta-burst~     stimulation, iTBS) using a randomized, blinded crossover design: participants will receive~     active or sham iTBS for two weeks and then switch groups without them or clinicians knowing~     their group. The investigators hypothesize that brain function and performance with language~     tasks will change after active iTBS.~   "
31584|NCT03153657|"~     Objectives: This study aims to evaluate the effectiveness of preemptive administration of~     non-steroidal anti-inflammatory Piroxicam-beta-Cyclodextrin on risk and level of tooth~     sensitivity caused by in-office bleaching procedures using 35% hydrogen peroxide.~      Fifty patients will be selected for this triple-blind, randomized, cross-over,~     placebo-controlled clinical trial. Piroxicam-beta-Cyclodextrin (200 mg) or placebo will be~     administrated in a single-dose thirty minutes prior to bleaching procedure. The whitening~     treatment with 35% hydrogen peroxide will be carried out in two sessions with a 7-day~     interval. Tooth sensitivity will be assessed Immediately before bleaching agent removal and~     up to 24 hours after each session the procedure using analog visual and verbal scales. Color~     alteration will be assessed by a bleach guide scale 7 days after each session. Relative risk~     to sensitivity will be calculated and adjusted by session; while comparison of overall risk~     will performed by Fisher's exact test. Data on the sensitivity level for both scales and~     color shade will be subjected to the Mann-Whitney and Friedman tests, respectively (α =~     0.05).~   "
31585|NCT03153644|"~     The purpose of this project is to describe how contraceptive services are currently being~     delivered to women with medical conditions who seek care in community-based primary care~     settings, such as family medicine and internal medicine clinical offices.~   "
31586|NCT03153631|"~     Breast cancer is the most frequently diagnosed cancer and the leading cause of cancer death~     among females world wide. breast cancer alone accounts for 25% of all cancer cases and 15% of~     all cancer deaths among females.~   "
31587|NCT03153618|"~     The collection and analysis of family, medical, lifestyle, and environmental exposure history~     (a Comprehensive Health History or CHH) can identify critical risk factors for many chronic~     and life-threatening conditions, including cancer. Despite its importance, CHH is~     infrequently documented and analyzed in primary-care medical practice due to numerous~     hurdles, and currently available tools have proven inadequate to address this critical~     problem. This study will evaluate the Virtual Agent Linked Intelligent Disease Assessment~     Tool Engine (VALIDATE) system as an easy to administer, accurate, cost-effective, and~     clinically useful tool for collecting and analyzing structured CHH data.~   "
31588|NCT03153605|"~     Explore the correlation and specific relationship between chromaticity parameters and~     treatment satisfaction before and after tooth bleaching, compare the curative effect of~     different tooth bleaching programs.~   "
31589|NCT03153592|"~     Laparoscopy and robotic techniques are widespread procedures for pelvic gynecologic, urologic~     and abdominal surgery often performed in Trendelenburg position, with the application of~     pneumoperitoneum by inflating carbon dioxide. The rise in abdominal pressure following~     pneumoperitoneum and the head down body position have been shown to impair the respiratory~     function during the procedure, mainly inducing atelectasis formation in the dependent lung~     regions, worsening stress and strain of the alveolar structure.~      The application of a ventilator strategy providing positive end-expiratory pressure (PEEP)~     has been shown to reduce the diaphragm cranial shift, increasing functional residual capacity~     and decreasing respiratory system elastance. Furthermore, the application of recruiting~     maneuver followed by the subsequent application of PEEP improved oxygenation. These results~     are in accordance with finding by Talmor et al, evaluating the effect of a mechanical~     ventilation guided by esophageal pressure in acute lung injury patients.~      However a comparison between an esophageal pressure piloted mechanical ventilation and a~     conventional low tidal ventilator strategy with adjunct of PEEP and recruitment maneuvers~     according to clinical judgment has never been investigated in patients undergoing robotic~     gynecologic, abdominal or urologic surgery. The investigators aim to compare the conventional~     ventilation strategy (i.e. with application of PEEP and recruitment manoeuvre) with a~     ventilation driven by transpulmonary pressure assessed through an esophageal catheter, in~     patients undergoing to robotic surgery, with respect to oxygenation, expressed in terms of~     arterial oxygen tension - inspired oxygen fraction ratio (PaO2/FiO2) (primary endpoint),~     intraoperative respiratory mechanics indexes, number of lung recruitment maneuvers, rate and~     type of perioperative complications until hospital discharge (additional endpoint).~   "
31590|NCT03153579|"~     Background: Lysergic acid diethylamide (LSD) was extensively investigated in humans the 1950s~     and 1960s. Particularly, LSD attenuated anxiety in patients with cancer. Clinical research~     with LSD ended in the 1970s due to regulatory restrictions but its use for personal and~     recreational purposes continued. In recent years, there has been a renewed interest in the~     use hallucinogens in psychiatric research and practices. LSD and psilocybin were reused in~     experimental studies in healthy subjects and in the treatment for anxiety in patients with~     life-threatening diseases. Specifically, a pilot study documented that LSD can be used safely~     and may reduce anxiety in these patients. Larger well-designed and placebo-controlled studies~     are warranted. Similar studies have recently been completed with the hallucinogen psilocybin.~      Objective: To test the efficacy of LSD in patients with anxiety with or without~     life-threatening diseases.~      Design: Double-blind, placebo-controlled random-order cross-over trial using two LSD (200 µg)~     and two placebo sessions with subjects acting as their own control.~      Participants: 40 patients aged > 25 years with anxiety disorder (according to DSM-IV or a~     state-trait anxiety inventory score >40 in the STAI trait or state scale) with or without~     life-threatening illness.~      Main outcome measures: Reduction in anxiety (STAI), depression (Hamilton depression rating~     scale, HDRS and Beck depression inventory, BDI), and general psychopathological symptoms~     (Symptom Check List 90 items, SCL-90) at 2, 8, and 16 weeks after LSD- compared with~     placebo-assisted psychotherapy.~      Significance: Anxiety disorder (alone or in the context of life-threatening illness) is~     frequent and often insufficiently managed with available medications. This study will~     evaluate the potential benefits of single treatments with LSD in anxiety disorder.~   "
31591|NCT03153566|"~     Cutaneous and genital warts are common dermatological conditions caused by Human Papilloma~     Virus. Although it is a benign condition it causes disfigurement, has tendency to collect,~     can be transmitted to others, this makes adequate and timely treatment important, while many~     warts are resolve spontaneously over several years, most patients seek treatment because the~     warts are unsightly and often tender or painful.~   "
31592|NCT03153553|"~     Regular physical activity improves aspects such as physical fitness, fatigue, quality of~     life, gait and also reduces the rate of progression of disability in individuals with~     Multiple Sclerosis. However, individuals with multiple sclerosis are less physically active~     than the general population. The determinants of engaging in physical activity for~     individuals with multiple sclerosis include psychological factors like motivation,~     self-belief and self-regulatory constructs and physical factors like fatigue, weakness, pain~     and ataxia.~      Ischemic preconditioning is exposure of the body to brief periods of circulatory occlusion~     and re-perfusion to protect organs against ischemic injury. Recent studies have also shown~     that ischemic preconditioning also improves exercise performance in healthy participants.~      The primary aim and objective of this study is to see whether it is feasible to use Ischemic~     preconditioning to improve exercise performance in people with Multiple Sclerosis.~      The design for the study is a double blind randomized control trial. Forty patients with~     multiple sclerosis above 18 years of age and who have the ability to walk will be randomized~     to receive either Ischemic preconditioning or sham intervention. All participants will be~     identified by MS consultants and nurses from the MS clinic and Neuro Day Case Unit of the~     Royal Hallamshire Hospital in Sheffield. Participation will involve an additional 2 hours of~     the patients time.~   "
31597|NCT03153488|"~     This is a 6-month open-label, randomized control trial in adults to find out if certain~     neuromarkers can predict individual treatment response to stimulant medications for Attention~     Deficit Hyperactivity Disorder (ADHD). Males and females, ages 18-55, will be randomized to~     receive either an amphetamine or a methylphenidate formulation for their ADHD. Before~     beginning to receive medication treatment, each subject will complete an MRI scan at MIT.~   "
31598|NCT03153475|"~     Five-year, Prospective, multi-center, non-randomized, non-controlled study of the ATTUNE®~     Revision total knee prostheses, utilizing the fixed bearing (FB) and rotating platform (RP)~     tibial component with the posterior stabilizing (PS) femoral component in revision total knee~     arthroplasty.~   "
31599|NCT03153462|"~     A multicenter, open-label expanded access protocol for the treatment of subjects with~     relapsed/refractory large B-cell lymphoma.~   "
31600|NCT03153449|"~     Five-year, Prospective, multi-center, non-randomized, non-controlled study of the ATTUNE®~     Revision total knee prostheses, utilizing the fixed bearing (FB) and rotating platform (RP)~     tibial component with the posterior stabilizing (PS) femoral component in complex primary~     total knee arthroplasty.~   "
31601|NCT03153436|"~     The objective of this study is to evaluate the effect of in-vitro myoinositol supplementation~     of human sperm on the outcome of cryopreservation.~   "
31602|NCT03153423|"~     To evaluate preoperative risk factors for overcorrection and undercorrection following~     surgery for basic intermittent exotropia such as axial length of the globe, refractive error,~     age and sex~   "
31603|NCT03153410|"~     This study will be looking at whether combining cyclophosphamide, pembrolizumab (an antibody~     that blocks negative signals to T cells), GVAX (pancreatic cancer vaccine), and IMC-CS4~     (LY3022855) (an antibody that blocks a molecule called CSF1-R which prevents the bodies~     ability to fight cancer) is effective (anti-tumor activity) and safe in patients with~     borderline resectable pancreatic cancer.~   "
31604|NCT03153397|"~     This study plans to learn more about the impact of enteral nutrition on bacteria in~     critically ill trauma patients with brain injury. Specifically, it seeks to understand the~     effect that a prebiotic containing enteral feeding formula (Nutraflora scFOS in Vital AF) has~     on the gut, oral, and skin bacteria. A prebiotic is a special form of dietary fiber that acts~     as a fertilizer for good bacteria. The prebiotic Nutraflora scFOS has been cleared by the~     U.S. Food and Drug Administration and is not considered investigational as used in this~     study. Enteral feeding is a way to give nutrition to critically ill people who are unable to~     eat.~   "
31605|NCT03153384|"~     To evaluate the performance of a single high volume blood culture sampling strategy versus~     the actually used multiple sampling strategy for the diagnosis and categorization of~     infective endocarditis according to the Duke-Li classification in a Population of adults~     suspected of infective endocarditis.~   "
31606|NCT03153371|"~     This study attempts to identify two types of AD by using clinical and cognitive tasks and~     brain imaging. The subtypes of AD are separated into a typical group (memory loss) and a~     variant group (language, visuospatial, and other cognitive difficulties). Performance on~     the clinical tasks and brain imaging will be compared among the young-onset Alzheimer's~     disease group, a late-onset Alzheimer's disease group, and a control group.~   "
31607|NCT03153358|"~     Many patients with oncogene-driven non-small-cell lung cancer (NSCLC) treated with tyrosine~     kinase inhibitors experience limited sites of disease progression. For multiple metastases in~     patients with advanced NSCLC, increased local treatment may benefit to prolong patient~     survival. This study investigated the benefits of icotinib limited systemic disease~     progression and continuation of Stereotactic Body Radiation Therapy,in patients with~     metastatic EGFR-mutant NSCLC.~   "
31608|NCT03153345|"~     Objectives: To investigate the efficacy of bedside respiratory muscle training on pulmonary~     function and stroke-related disabilities in stroke patients.~      Design: Prospective randomized controlled trial~      Setting: A single physical medicine and rehabilitation department at a university hospital~      Participants: Stroke patients in a rehabilitation unit were recruited and randomly assigned~     to either the intervention group or the control group.~      Intervention: Both groups participated in a conventional stroke rehabilitation program.~     During the study period, the intervention group received bedside respiratory muscle training~     twice a day for three weeks. The respiratory muscle training consisted of (1) a breath~     stacking exercise, (2) inspiratory muscle training and (3) expiratory muscle training. The~     participants were evaluated at baseline and again at the end of the study (3 weeks later).~      Main Outcome Measures: The primary outcomes were measures of pulmonary function: functional~     vital capacity (FVC), forced expiratory volume in one second (FEV1) and peak flow.~      Secondary outcomes were stroke-related disabilities assessed by the following: National~     Institutes of Health Stroke Scale, Modified Barthel Index, Berg Balance Scale, Fugl-Meyer~     Assessment, the Korean Mini-Mental State Examination, and the incidence of pneumonia.~   "
31609|NCT03153332|"~     To our knowledge, it has not been analyze whether 3D printed liver model would improve the~     perception of a given liver tumor or the precision of operation planning in liver surgery. We~     design this prospective controlled trial to test whether the 3D-printed patient specific~     liver model could be more informative than standard MDCT (multi-row detector computed~     tomography ) and 3D visualization system in predicting the surgical anatomy of liver.~   "
31610|NCT03153319|"~     Randomized, double-blind, placebo-controlled, parallel-group, single-center study followed by~     open-label phase, to evaluate the effects of adalimumab compared to placebo on the change~     from baseline in joint and skeletal disease in children and adults with mucopolysaccharidosis~     (MPS) I or II.~   "
31611|NCT03153306|"~     Correction of hypovolemia is an important therapeutic measure，Even though there is no~     consensus regarding infusion rates, a plasma volume (PV) expander is often given at a fast~     rate to treat a suspected hypovolemia without delay which can be associated with aggravation~     of adverse interstitial accumulation of macromolecules and fluid, especially in inflammatory~     conditions such as sepsis.the smallest possible volumes for PV resuscitation to maintain~     normovolemia should be used to reduce the risk of simultaneous interstitial fluid~     accumulation. The investigators tested the hypothesis that a slow infusion rate of a PV~     expander results in better plasma expansion than a fast infusion rate to patients with severe~     sepsis or septic shock.~   "
31612|NCT03153293|"~     This study is meant to evaluate the safety and efficacy of rAAV2-ND4 treatment for Leber~     hereditary optic neuropathy with the G11778A mutation in mitochondrial DNA.~   "
31613|NCT03153280|"~     This study is a phase Ib, open label, multi-centre trial designed to estimate the Maximum~     Tolerated Dose (MTD) of lithium when combined with a standard chemotherapy regimen of~     oxaliplatin and capecitabine in patients with advanced, unresectable, oesophago-gastric or~     colorectal cancer who have received no previous treatment for advanced disease (previous~     adjuvant or neo-adjuvant treatment is acceptable if completed at least 6 months prior to~     registration).~      The study follows a modified Fibonacci, 3+3, dose escalation design. Patients are enrolled in~     cohorts of 3. All three patients in each cohort must complete at least two cycles of~     treatment to be evaluable for toxicity. If a patient cannot complete 2 cycles, another~     patient will be enrolled.~   "
31614|NCT03153267|"~     The purpose of this study is to compare the efficacy of 7-day versus 14-day doxycycline~     treatment in patients with erythema migrans.~   "
31615|NCT03153254|"~     The purpose of this study is to investigate the usability of a new upper limb robot assisted~     therapy device in stroke patients.~   "
31616|NCT03153241|"~     Ventilator-associated pneumonia (VAP) continues to be a major cause of morbidity and~     mortality in the intensive care unit (ICU). Microaspiration of subglottic secretions~     accumulated above the endotracheal tube cuff is the primary route of bacterial entry into the~     lower respiratory tract.Therefore, removal of secretions from the subglottic spacehas been~     recommended as a preventive strategy to avoid microaspiration and VAP. In this context,~     whereas considerable literature exists on the use subglottic secretion drainage (SSD) in~     patients at risk for developing VAP, there is a lack of data on the bacterial growth in the~     subglottic fluid above the cuff.~      The primary objective of the study will be to assess the value of subglottic secretion~     culture in predicting microbial flora of endotracheal aspirate samplein patients admitted to~     our ICU and under invasive mechanical ventilation for at least 48 hours. Secondary end-point~     will be to estimate the predictive value of subglottic secretion culture in identifying~     bacterial pathogens in the sub-population of patients who will develop VAP.~   "
31617|NCT03153228|"~     Electronical cigarettes, also known as e-cigarettes are a new phenomenon, which steadily~     wins more aprobation among smokers. However, there exists no much data concerning the effects~     of acute exposure to electronic cigarettes vapour on the respiratory system.~      The aim of the present study is to evaluate and compare the acute response to electronic and~     traditional cigarettes in healthy smokers.~   "
31618|NCT03153215|"~     Severe fetal growth restriction (FGR) complicates approximately 0.4% of pregnancies and~     severely increases the risk of perinatal morbidity and mortality.Sildenafil citrate may offer~     a potential therapeutic strategy to improve uteroplacental blood flow in IUGR pregnancies.~   "
31619|NCT03153202|"~     The purpose of this study is to determine the most appropriate dose for the combination of~     ibrutinib and pembrolizumab and to see if the combination is active for the disease. The~     study will monitor for any side effects and if the combination of ibrutinib and pembrolizumab~     works in the cancers being studied.~      There will be 2 experimental drugs given to the subject in this study. One experimental drug~     used in this study is called ibrutinib and the second is called pembrolizumab.~      This is the first time that ibrutinib will be used in combination with pembrolizumab. This~     combination is considered experimental. Experimental means that it is still being tested to~     see if it is safe and effective. Ibrutinib is a new drug known as a 'Bruton's Tyrosine Kinase~     (BTK) inhibitor'. Ibrutinib blocks an enzyme (protein) that affects how certain types of~     blood cancer cells grow and survive. Blocking this enzyme is a very important mechanism in~     killing blood cancer cells. Ibrutinib has been approved in the United States, Israel, and the~     European Union for use in adult patients with mantle cell lymphoma (MCL) and adult patients~     with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.~     Pembrolizumab is an antibody (a type of human protein) that is being tested to see if it will~     allow the body's immune system to work against tumor cells. Pembrolizumab is approved for use~     by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with~     melanoma (skin cancer) who have received prior treatments. Pembrolizumab is not FDA approved~     to treat patients with chronic lymphocytic leukemia [CLL] and mantle cell lymphoma [MCL].~   "
31620|NCT03153189|"~     To find out the relationship between physical activity and~        -  self-esteem,~        -  sleep quality,~        -  anxiety & depression,~        -  body fat percentage,~        -  quality of life, in college females~   "
31621|NCT03153176|"~     Background: The health promotion actions carried out in the school environment have positive~     effects on reducing risk factors for chronic diseases in adolescents. Interdisciplinary~     strategies involving school and family to increase the level of physical activity among~     adolescents, inside and outside the school, are essential to encourage healthier lifestyles.~      Aim: To determine whether a 24-weeks interdisciplinary intervention program promotes~     improvement in the level of physical activity, physical fitness, sleep quality, life~     satisfaction, eating habits and reduce the sedentary behavior of schoolchildren aged 10 to 13~     years of public schools in the city of Presidente Prudente, São Paulo, Brazil.~      The intervention: Includes training of teacher Physical Education in the principles of~     self-determination theory and ecological theory at practical applications for motivating~     adolescents in physical activities and sports. The students will be given information on the~     benefits of a physically active lifestyle and will be encouraged to participated the new~     opportunities for physical activity in their school and community. The program will offer~     physical activity strategies over the 24-weeks during class Physical Education, afternoon~     recess and active lesson breaks in theoretical classes. Nutritional guidelines and gardening~     experience will be developed to encourage healthy eating habits among schoolchildren and to~     reduce salt, oil and sugar in the preparation of school lunch.~      Methods/design: The project, which being conducted as cluster randomized trial, is to~     evaluated whit in a mixed methods, including qualitative and quantitative approach will be~     used for the construction of the actions integrated to the school physical education~     curriculum and evaluation of the program by the participants and supporters. The RE-AIM~     evaluation metric (Reach, Effectiveness, Adoption, Implementation, and Maintenance) is used~     to guide the validation this program.~   "
31622|NCT03153163|"~     This is an open-label Phase I study of single-agent trastuzumab emtansine administered by~     intravenous (IV) infusion. The study will characterize the pharmacokinetics of trastuzumab~     emtansine and its relevant analytes and the safety of trastuzumab emtansine in Chinese~     participants with human epidermal growth factor receptor 2 (HER2)-positive locally~     advanced/metastatic breast cancer (LA/MBC).~   "
31623|NCT03153150|"~     Primary research question: For adults surviving spontaneous (non-traumatic) symptomatic~     intracranial haemorrhage with persistent/paroxysmal atrial fibrillation/flutter (AF), does~     starting full treatment dose oral anticoagulation (OAC) result in a beneficial net reduction~     of all serious vascular events compared with not starting OAC?~      Trial design: Investigator-led, multicentre, randomised, open, assessor-masked, parallel~     group, clinical trial of investigational medicinal product (CTIMP) prescribing strategies.~     Investigators plan for a pilot phase, followed by a main phase.~   "
31625|NCT03153124|"~     Patients with chronic kidney disease in hemodialysis have complex syndrome with diverse~     effects on cardiovascular, nervous, respiratory, musculoskeletal, immune and~     endocrine-metabolic systems. With regard to the musculoskeletal structure, there is~     progressive muscular loss with consequent increase in muscle weakness, limited resistance,~     exercise intolerance and fatigue, as well as functional and morphological abnormalities~     characteristic of uremic myopathy. Respiratory muscles are also affected as a result of~     uremic myopathy, with decreased strength and resistance. Objective: to analyze the impact of~     respiratory muscle training on muscle strength, functional capacity and quality of life of~     patients with chronic kidney disease on hemodialysis. Method: This is a prospective,~     randomized study involving 46 patients followed by the dialysis unit of a university~     hospital, over 18 years old, of both genders who underwent hemodialysis for more than six~     months and who signed the informed consent form. Patients will be allocated into two groups:~     respiratory muscle training with PowerBreath and control. All will be evaluated for~     demographic data, respiratory muscle strength, lung function, functional capacity and quality~     of life. The intervention group will perform three months of intradialytic training of a~     physical therapy protocol with PowerBreath. Both groups will be reevaluated after three~     months.~   "
31626|NCT03153111|"~     This is a study to evaluate whether macitentan is an effective and safe treatment for~     patients with heart failure with preserved ejection fraction (HFpEF) and pulmonary vascular~     disease.~      The primary objective is to evaluate whether macitentan 10 mg reduces N-terminal pro-brain~     natriuretic peptide (NT-pro-BNP) as compared to placebo in these patients.~   "
31627|NCT03153098|"~     There is a high prevalence of inactive adults in the United Kingdom (UK), many of whom suffer~     from conditions such as diabetes, cardiovascular disease, and poor mental health. These~     problems often co-exist more frequently in areas of higher socio-economic deprivation. There~     is an ongoing need to test the effectiveness, acceptability, and sustainability of community~     physical activity interventions. The Active Herts programme is a community physical activity~     programme aimed at inactive adults aged 16 and over who have one or more risk factors for~     cardiovascular disease (CVD) and/or a mild to moderate mental health condition. The programme~     uses the latest evidence-based behaviour change techniques to target physical activity,~     wellbeing, and key drivers of behaviour from the COM-B ('Capability', 'Opportunity',~     'Motivation' and 'Behaviour') model of behaviour change.~      This evaluation will follow a mixed-methods longitudinal (baseline, and 3, 6 and 12 month~     follow-ups) pragmatic observational design. Two types of programme are being delivered, each~     in a different area. In one, group participants will receive a behaviour change technique~     booklet, consultations (baseline, and optional at 3, 6, and 12 months), a booster phone call~     (week 2), motivational text messages (weeks 3, 6, and 12), and signposting to 12 weeks of~     exercise classes. In the other 'enhanced delivery' group, participants will receive the same~     but the 12 weeks of exercise will be free and tailored to their needs, and there will be~     optional exercise 'buddies' available. An outcome evaluation will assess changes in physical~     activity as the primary outcome, and sporting participation, sitting, wellbeing,~     psychological capability, and reflective motivation as secondary outcomes. A process~     evaluation will use both one-to-one interviews and focus groups to explore the views of~     stakeholders, delivery staff, and participants over three phases (set-up, deviations in the~     delivery of the intervention, and looking back over the intervention). Economic evaluation~     will examine the costs of the Active Herts programme against the benefits gained in terms of~     reduced risk of morbidity from a range of chronic conditions.~      This study will measure key drivers of physical activity using up to date behaviour change~     theory, allowing evaluation of not only whether physical activity has increased but also why.~     The research will inform the future development of a scalable intervention that can be more~     robustly tested in a randomised controlled trial.~   "
31628|NCT03153085|"~     The purpose of this study is to determine if TBI-1401(HF10) in combination with ipilimumab is~     effective in Japanese patients with stages IIIB, IIIC, or IV unresectable or metastatic~     melanoma.~   "
31629|NCT03153072|"~     The supra ventricular tachycardia is the most common symptomatic arrhythmia in pediatrics.~     Amiodarone is an antiarrhythmic drug used in this indication. Pharmacokinetic, efficacy and~     safety data are not known in the pediatric population due to the lack of a suitable specialty~     available on the market.~      The development of an amiodarone oral solution formulation adapted to this age group should~     provide a therapeutic alternative and collect data on the pharmacokinetics, efficacy,~     acceptability and tolerability of the drug.~   "
31630|NCT03153059|"~     We hypothesized that some difference in the composition and distribution of gut microbiota in~     people with a large number of defecation (two or three times a day or more), people with~     normal defecation (one time a day or two days), and people with a small number of defecation~     (two times a week or less).~      And we investigate the association between gut microbiota and stool frequency.~   "
31631|NCT03153046|"~     The investigators propose a maltodextrin-controlled cross over experimental medicine study~     that aims to examine the role of the immune system in cognitive processes and weight gain in~     40 adult patients with psychosis, stable on antipsychotic medication for over 1 month. There~     is evidence suggesting the immune system is linked to brain function and weight gain, both~     parameters that has been implicated in psychosis and antipsychotic use, and may underlie some~     schizophrenic features. The fermentation of galacto-oligosaccharides (GOS), which are short~     chain carbohydrates composed mostly of galactose sugar molecules, by the intestinal~     microbiota has been shown to modulate the immune system and reduce the inflammatory response~     in both animals and humans. Since the intestinal ecosystem is highly sensitive to dietary~     changes, the growth of beneficial gut bacteria can be enhanced using a natural food~     supplement similar to GOS known as prebiotics. The study will be controlled by taking~     maltodextrin as a control supplement. Both prebiotics and maltodextrin are short chain sugar~     compounds. The study will involve asking patients to take dietary supplement for a total of~     24 weeks; GOS for 12 weeks and maltodextrin for 12 weeks as a control. Participants will be~     randomised into groups, with half receiving maltodextrin followed by GOS, and half receiving~     GOS followed by maltodextrin. Participants will be assessed on cognitive function and weight~     gain at 3 specified time points.~   "
31632|NCT03153033|"~     What are the implications of wheelchair propulsion-induced fatigue for the development of~     shoulder pain and how can this knowledge improve prevention programs?~      With this project, the Shoulder Health and Mobility group of the Swiss Paraplegic Research~     in Nottwil (Switzerland) wants to investigate how fatigue during wheelchair propulsion~     affects risk factors for shoulder pain of persons with a spinal cord injury (SCI). The~     investigators want to find out how the handrim wheelchair propulsion technique changes with~     fatigue and want to define persons who are susceptible to fatigue.~      Getting life back after a SCI will most likely occur with the help of a wheelchair, whether~     it is at the beginning of rehabilitation or throughout further life. Gaining back mobility~     and participation in social life is important, also because of the multiple positive effects~     of physical activity on person's health and self-esteem, preventing several chronic diseases.~     Therefore, it is needed to try to stay away from shoulder injuries. Since the shoulder is~     very mobile and thus unstable, the joint is at increased risk for injuries. This is reflected~     in the high amount of persons with a SCI having shoulder pain (between 30 to 70 %). Once pain~     or an injury occurred, it is hard to recover, as so far no effective treatment is available.~     Several factors as gender, weight, age, level and completeness of the SCI, movement patterns~     and muscle strength were found to be related with injury and pain. However, it is currently~     not well understood what exactly causes shoulder injuries.~      Handrim wheelchair propulsion is an inefficient mode of propulsion and asks a lot of demands~     to the upper body. Because of the inefficient movement and the shoulder being prone to~     injuries, wheelchair propulsion has a high chance of inducing shoulder injuries and pain.~     Propelling with a technique minimizing the loads on the shoulders and improving the capacity~     to perform these movements (as increasing muscle strength) is of utmost importance as these~     factors can be modified by training. Previous intervention programs have learned wheelchair~     users to propel with long and smooth strokes aiming to reduce the loads. Although someone~     might be aware of the recommended techniques and can apply them, propulsion technique might~     change with fatigue and could become less optimal. A similar phenomena happens for example in~     landing strategies from a jump. In a fresh state, persons will try to have a stable landing~     reducing the impact on the lower limbs. With fatigue, however, there will be a tendency to~     forget about the proper landing technique which on its turn can increase the risk of~     injuries. This was suggested to be one of the reasons why there is an increased prevalence of~     injuries towards the end of a game. So far, it is unclear how fatigue alters propulsion~     technique and how these changes are related with an increased risk of shoulder pain.~      Tis project aims to achieve the goals by investigating how very strenuous wheelchair~     propulsion (fatigue intervention) of 15 minutes alters the propulsion technique of 50 persons~     with a SCI. All participants will perform the fatigue protocol in the movement analysis lab~     at the Swiss Paraplegic Research. During the protocol, participants will be requested to~     perform as many 8 loops as possible with their wheelchairs, including starts, stops, and~     right and left turns. Before and after the protocol, movement patterns, muscle usage and~     loads during wheelchair propulsion and the characteristics of the shoulder muscle tendons~     during rest will be assessed. Furthermore, the person's characteristics, such as weight, age,~     gender, time since injury, injury level, health conditions, use of medication, muscle~     strength and activity levels will be assessed. All these factors might be associated with the~     susceptibility to fatigue.~      To answer our questions, we will first compare the propulsion technique (movement patterns,~     loads, and muscle usage) before and after the protocol to investigate the direct effect of~     fatigue. Secondly, we will investigate the association of negative changes in tendon~     appearance (which has been related to injury) with the changes in the propulsion technique to~     investigate the implications of acute changes that might increase the risk of injury. Finally~     we will run a model including all variables to determine which person's characteristics are~     associated with an increased susceptibility to fatigue.~      The results will be highly relevant as it will give answers about the content, the aims and~     the target population of prevention programs for shoulder injury, aiming to improve mobility,~     participation, and quality of life in persons with SCI.~   "
31633|NCT03153020|"~     The effectiveness of emergency management of acute ischemic stroke has improved considerably~     in recent years with thrombolysis and more recently thrombectomy. This improvement is~     accompanied by an increase in the number of stroke survivors. One of the major issues for~     these ever-increasing survivors is the prevention of recurrence. According to data from the 3~     French registries, more than 20% of patients have at least one recurrence. Secondary~     prevention treatment has demonstrated his efficacy to prevent stroke recurrence.~      This evolution justifies identifying factors associated with adherence to secondary~     prevention treatment, measured at 1 year post-stroke / transient ischemic attack (TIA), in~     patients included in the STROKE 69 cohort.~   "
31668|NCT03152565|"~     Single arm Phase I/II multicentric open labeled, with translational sub-study, of avelumab~     plus autologous dendritic cell vaccine in pre-treated mismatch repair-proficient (MSS)~     metastatic colorectal cancer patients..~   "
31634|NCT03153007|"~     Foot ulceration is a common and costly complication of diabetes. GSK1278863 is a topical~     drug, which is being developed to treat wounds associated with DFU. The aim of this study is~     to explore the symptoms and impacts of DFU from the subject perspective and to elicit~     in-depth information about DFU signs and symptoms, impacts on functioning and health-related~     quality of life (HRQoL). Adult DFU subjects with current or recent (within last six months)~     neuropathic foot ulcers will be eligible to participate in this prospective, cross-sectional~     interview study. Approximately 20 DFU subjects will be recruited from up to three clinical~     sites. Potential subjects will be pre-screened and then contacted to gauge interest in the~     study. Interested subjects will be screened and eligible subjects will consent to release~     contact information to research staff. Research staff will contact the subject to schedule~     interviews. This study will include concept elicitation interviews over the telephone or~     in-person by trained and experienced interviewers. In-person interviews will be conducted in~     a private room at the clinical site. All interviews will be conducted in English and will be~     guided by semi-structured interview guides. All subjects will provide written consent prior~     to the start of the interview.~   "
31635|NCT03152994|"~     Chronic obstructive pulmonary disease(COPD), characterized by persistent airflow limitation,~     associated with an progressive chronic inflammatory response of the lung to noxious particles~     or gases, can lead to dyspnea and limited mobility and influence the life quality of patients~     severely. Type 2 diabetes mellitus(T2DM), as a common complication of COPD, has got more~     attention in comprehensive control of COPD. Stress response and metabolic disorder are more~     likely to happen in COPD patients with T2DM in high level inflammation status, which decrease~     the drug efficacy, increase the risk of acute exacerbation of COPD, complications and~     mortality.~      Both COPD and T2DM are chronic inflammatory disease with long term, there is close~     relationship in occurrence and development of each other, and the patients with severe COPD~     are more likely to develop T2DM. Monitoring the acute inflammation maker of C reactive~     protein (CRP) and IL-6(interleukin-6) is the most useable way to predict the inflammatory~     status and condition of COPD patient with T2DM, however the chronic inflammation maker is~     lacking. Neutrophil-to-Lymphocyte ratio(NLR), platelet-lymphocyte ratio (PLR) and~     lymphocyte-monocyte ratio (LMR) , the new, cheap and easy-tested chronic inflammatory~     markers, have got great research in early predicting the tumor such as nasopharyngeal~     carcinoma, soft tissue sarcoma and small-cell lung cancer,among them, NLR has manifest~     promising application in predicting insulin-resistance. However the value about NLR,PLR and~     LMR to predict the T2DM in COPD patients remain unknown and many articles related to NLR and~     COPD are retrospective.~      The investigators attempt to analyze the risk factors and predict value of NLR,PLR and LMR~     about developing T2DM in COPD patients with prospective method.~   "
31636|NCT03152981|"~     In the present study, The investigators evaluated whether anesthetic agents effects on Optic~     Nerve Sheath Diameter in patients undergoing Robot Assisted Laparoscopic Radical~     Prostatectomy~   "
31637|NCT03152968|"~     Fundamental movement skill is the precursor for physical activity in later life. Proficiency~     of Fundamental Movement Skills in Indian School Children is unknown. This observational trial~     shall tell us how proficient are our Udupi District Children.~   "
31638|NCT03152955|"~     Perioperative pain is caused by a variety of harmful factors through multiple mechanisms,~     therefore, reasonable postoperative analgesia should be combined with drugs or measures of~     different mechanism , which is called multimodal analgesia. Multimodal analgesia could~     minimize side effects and achieve a better analgesic effect. Commonly used strategies of~     multimodal analgesia are oral analgesic drug, nerve block, patient controlled analgesia and~     so on. This study will observe the effect of multimodal analgesia on postoperative pain in~     patients with microvascular decompression and record side effects. Finally, it will provide~     technical support for the guidance of postoperative analgesia in patients of trigeminal~     neuralgia.~   "
31639|NCT03152942|"~     The aim of this study is to investigate whether the combination of aminophylline and~     Progesterone (P4) is acceptable to women at high-risk of Pre-term labour (PTL). If this~     proves to be the case, a larger double blind, randomised controlled trial will be conducted~     to test the hypothesis that the combination of P4 and aminophylline reduces the risk of PTL~     more effectively than P4 alone.~      The study is a randomised study where participants will be either administered a combination~     of aminophylline and Progesterone (P4) or Progesterone (P4) alone.As the study is open label,~     the participants and the study doctor will know which study medications the participant is~     taking at all times during the study.~   "
31640|NCT03152929|"~     The purpose of this study is to compare two standard methods of pain control management used~     at Spectrum Health for patients undergoing breast surgery. The two methods being compared are~     the paravertebral block and the pectoral nerve block. Postoperative pain control is essential~     following any major operative procedure. A variety of methods have been utilized to ensure~     adequate analgesia, each with its own advantages and risks. Increasingly, attention has~     focused on regional methods of analgesia, which may allow for reduction in systemic narcotic~     use and their associated complications. Proposed benefits of regional analgesia and a~     resultant reduction in narcotic use include decreased risk of cancer progression, decreased~     length of stay, and decreased risk of ileus.~   "
31641|NCT03152916|"~     This study aims to use 3D printing personalized plate to locate the position in which the~     K-wires would be drilled to save operation time and decrease the number of times that the~     K-wires are drilled.~   "
31642|NCT03152903|"~     This is a Phase II/III trial with two groups of adults successfully cured of category 1~     pulmonary TB receiving either VPM1002 or placebo. Single dose of VPM1002 / placebo will be~     administered to calculate efficacy of the vaccine against TB recurrence.~   "
31643|NCT03152890|"~     Glycemic control during liver transplantation is challenging especially after reperfusion of~     the liver graft. Insulin dose to treat postreperfusion hyperglycemia is retrospectively~     analyzed using historical data. The proposed dose then is prospectively applied to the~     patients to assess the adequacy of the insulin dose.~   "
31669|NCT03152552|"~     This is a dose-finding study to evaluate the efficacy, safety and tolerability of 3 different~     doses of LIK066 compared to placebo or empagliflozin in T2DM patients with heart failure~   "
45215|NCT02975024|"~     Apply the LSCI for follow-up the postoperative microcirculation after surgical procedures to~     enlarge keratinized gingiva in order to characterize the kinetics of the blood flow changes~     during wound healing in human subjects.~   "
31644|NCT03152877|"~     We propose a prospective, randomized, single blinded trial with subjects recruited from the~     WRNMMC Labor and Delivery Unit to study post-partum efficacy of Exparel® for pain control in~     patients undergoing a vaginal delivery who sustained a second, third, or fourth degree~     obstetrical laceration. Subjects who meet inclusion criteria and agree to participate in the~     study will be consented upon admission for active labor or induction of labor and will be~     randomized to receive either 20mL of liposomal bupivacaine or 20ml of 0.25% plain~     bupivacaine, infiltrated through the perineum at completion of their obstetrical repair.~     Current standard of care is to receive no injection of local anesthetic upon completion of~     the repair.~      The primary aim of the trial will be to evaluate post-partum pain using a visual analogue~     pain scale at days 1, 3 and 7 postpartum. All subjects will have acetaminophen, a~     non-steroidal anti-inflammatory drug and narcotic pain medication available for pain control~     regardless of assignment, which is the usual post-partum pain control regimen.~      We anticipate a 30% difference in post-operative pain measurements between the Exparel® group~     and the plain bupivacaine group. Other aims of this study are to evaluate total medication~     usage, comparing the study group to the control, and compare quality of life measures between~     the two study groups.~   "
31645|NCT03152864|"~     In order to assess the efficacy of the Rhythm Stabilization component of HealthRhythms'~     product, investigators will recruit 128 outpatients between the ages of 18 and 65, presenting~     to the University of Utah Department of Psychiatry outpatient clinics with a current mood~     and/or anxiety disorder. Sixty-four of these individuals will be randomly allocated to~     receive the full HealthRhythms package (Rhythm Sensing, Rhythm Trending, and Rhythm~     Stabilization) on their smartphones, while 64 will be asked to consent to Rhythm Sensing~     only. Participants in both arms will receive treatment as usual (TAU) for their mood and/or~     anxiety disorders, as typically provided at the University of Utah clinics. The duration of~     the study will be 16 weeks.~      The primary outcome measures of the RCT will be the PROMIS Depression, the PROMIS Anxiety and~     the PROMIS Sleep Disturbance computerized adaptive testing (CAT) measures. The investigators~     hypothesize that those receiving the full package will demonstrate lower levels of~     depression, anxiety and sleep disturbance. In addition, investigators will explore the~     relationship between sensed rhythm stability and scores on patient-reported outcome measures~     of mood, anxiety and sleep disturbance (PROMIS). The investigators hypothesize that positive~     changes in the PROMIS measures will be mediated by positive changes in rhythm stability.~      The primary outcome analyses will be based on random regression models, while the mediation~     analyses will follow the approach described by Helena Kraemer and colleagues.~   "
31646|NCT03152851|"~     Aim: to shorten the time of urination by bladder pressure stimulation in children less than~     36 months of age who need urinalysis to exclude or diagnose urinary tract infections and to~     speed up the start time of antibiotics treatment or to eliminate the overcrowding of~     emergency room(ER) by shortening the time of ER stay.~   "
31647|NCT03152838|"~     Autism Spectrum Disorder is a neurodevelopmental disorder characterized by impaired social~     communication and repetitive or stereotyped behaviors. According to the World Health~     Organization , the prevalence of Autism Spectrum Disorder is one person in 160.~   "
31648|NCT03152825|"~     A total chronic occlusion (CTO) is defined as a coronary obstruction with TIMI 0 flow lasting~     at least 3 months.The prevalence of CTO in patients with coronary disease is about 10-40%.~     Coronary collateralizations may supply sufficient perfusion to retain tissue viability, but~     do not protect from myocardial ischaemia. In fact, percutaneous revascularization (PCI) of~     CTO lesions leads to improved symptoms, functional class, quality of life, higher left~     ventricular ejection fraction and improved survival in several observational studies.~     However, due to the higher rate of procedural complications and lower success rate of PCI~     than in other settings, it is attempted in only 10% of all CTO lesions. Myocardial~     viability/ischaemia assessment should be performed before PCI to avoid potential PCI-related~     complications and identify patients who might benefit most from myocardial revascularization,~     individualizing the risk-to-benefit ratio. In this regard, patients with stable coronary~     artery disease who have moderate-to-severe ischaemia are at higher risk of event rates (death~     or MI of ~5%/year) and plausibly represent the best target for PCI.~      Cardiac MRI (CMR) provide a reliable assessment of both myocardial ischaemia and viability.~     Using late gadolinium enhancement (LGE) sequences, myocardial segments with LGE >75% of~     transmurality do not show any improvement in contractility even after revascularization,~     representing a subset of patients in which CTO PCI may be futile. Viability assessment by CMR~     may be also performed with low dose dobutamine infusion; in patients with CTO and akinetic~     segments, contractility improvement at low dose dobutamine may predict functional recovery in~     the follow-up. Myocardial ischaemia may be assessed by CMR with high accuracy, identifying~     perfusion defects during pharmacological-induced hyperemia and/or regional wall motion~     abnormalities during inotrope infusion.~      This study is designed to verify the hypothesis that myocardial ischaemia and viability~     assessed by CMR could identify patients who are more likely to benefit from PCI in terms of~     improvement in left ventricular remodeling, functional recovery and clinical outcome.~   "
31649|NCT03152812|"~     the investigators are trying to detect what is the best tissue constituent suitable for~     reconstruction of large post traumatic sof tissue defects of foot plantar surface~   "
31650|NCT03152799|"~     Ischaemic stroke causes significant morbidity and mortality and is a leading cause of~     disability within an ageing United Kingdom (UK) population. Proximal anterior circulation~     occlusion is associated with a particularly poor prognosis, but its management has undergone~     a paradigm shift following clinical introduction of endovascular recanalization, establishing~     rapid reperfusion of the ischaemic penumbra.~      Remote ischaemic conditioning (RIC) is highly effective at attenuating cerebral infarction in~     basic research studies and has the potential to further improve patient outcome if used as an~     adjunct to invasive revascularisation strategies. We aim to trial remote ischaemic~     conditioning at the time of revascularisation, and then daily for the duration of the~     seven-day in-patient stay, compared to a sham conditioning procedure. This pilot,~     single-centre study will determine efficacy/ tolerability of RIC to reduce cerebral~     infarction (primary endpoint: determined by brain magnetic resonance imaging [MRI]) and~     improve functional status (secondary end-points: National Institutes of Health Stroke~     Severity (NIHSS); European Quality of Life questionnaire EurQoL), with the data providing the~     necessary parameters for power calculations and leveraging charitable funding for a~     subsequent multi-centre study.~   "
31651|NCT03152786|"~     This randomized pilot clinical trial studies how well propranolol hydrochloride works in~     treating patients with prostate cancer who are undergoing surgery. When stressed, the body~     makes a molecule that may prevent tumor cells from dying, and propranolol hydrochloride may~     affect the signals in cells that cause tumor cells survival and death.~   "
32053|NCT03147495|"~     This study aims to research on the association between the inclination of the proximal~     tibiofibular joint surface and medial compartment knee osteoarthritis. The proximal~     tibiofibular joint radiographs of the participants will be taken. The angle of inclination of~     the proximal tibiofibular joint surface in two groups will be compared.~   "
31652|NCT03152773|"~     Background:~      Right heart catheterization tests heart pressures and flows. Magnetic resonance imaging (MRI)~     fluoroscopy shows pictures of the heart that doctors can watch while they work. Researchers~     want to test this procedure with a tool called a guidewire. This will help position the heart~     catheter into different heart chambers. Guidewires are usually considered unsafe during MRI~     because MRI can make them hot inside the body. Researchers have created special MRI settings~     that stop one guidewire from getting hot. Using this guidewire during MRI may make improve~     catheterization.~      Objectives:~      To test if certain MRI settings make it safe to use a guidewire during MRI fluoroscopy.~      Eligibility:~      Adults 18 and older whose doctors have recommended right heart catheterization.~      Design:~      Researchers will screen participants by reviewing their lab results and questionnaire~     answers.~      Participants will give 4 blood samples.~      Participants will be sedated. They will have a tube (catheter) placed in the groin, arm, or~     neck if they don t already have one.~      Patches on the skin will monitor heart rhythm. Special antennas, covered in pads, will be~     placed against the body.~      Participants will lie flat on a table that slides in and out of the MRI scanner as it makes~     pictures. Participants will get earplugs for the loud knocking noise. They can talk on an~     intercom. They will be inside the scanner for up to 2 hours. They can ask to stop at any~     time.~      For right heart catheterization, catheters will be inserted through the tubes already in~     place. The catheters are guided by MRI fluoroscopy into the chambers of the heart and~     vessels. The guidewire will help position the catheter.~   "
31653|NCT03152760|"~     Background:~      Alcohol use disorder (AUD) affects about 10 percent of people in the U.S. Studies show a~     relationship between the bacteria (microbiota) in the gut and the brain. Researchers think~     this may influence AUD. They want to learn more about changes in gut bacteria that may occur~     in people with AUD.~      Objectives:~      To study gut microbiota differences in current drinking versus abstinent people with AUD.~     Also to test if gut microbiota are related to alcohol cue-induced craving.~      Eligibility:~      People ages 21-65 who have AUD (both abstinent and current heavy drinkers) or are healthy,~     moderate drinkers~      Design:~      Participants will be screened in Protocol 14-AA-0181.~      Participants will have a first visit. They will have 4 more visits within about 10 days.~     Visits include:~      Fecal sample collection~      Physical exam~      Blood tests~      Assessment of diet and alcohol use~      X-rays to test body composition,~      They will sit under a ventilation hood to measure metabolism. They must fast 12 hours before~     this test.~      They will drink a solution. Their urine is collected over 5 hours.~      Ultrasound of the liver area. They must fast overnight before this test.~      At 2 visits, they will be in a bar-like setting. They will be exposed to stimuli associated~     with eating and drinking. They will rate their urge to drink alcohol and their food cravings.~      Participants will collect their stool throughout the study. They will also record information~     about their diet and daily activities like sleep and exercise.~      At the end of the study, participants will discuss their drinking. They will receive~     counseling if needed.~   "
31654|NCT03152747|"~     Phacoemulsification with implantation of posterior chamber lenses represents the gold~     standard of care for patients needing lens surgery, but there is an increased risk of~     developing pseudophakic retinal detachment after surgery. Especially myopic patients have an~     even higher risk of pseudophakic retinal detachment compared to the general population.~      The aim of this multicenter study is to document the presence and/or post-operative~     development of posterior vitreous detachment (PVD) and to assess its influence on the~     incidence of retinal detachment (RD) in myopes in a time period of three and five years after~     lens surgery.~      618 eyes of patients scheduled for regular lens surgery will be included, defined by an axial~     length of 25.0 mm or more. To examine the vitreous status, all patients will receive a~     comprehensive eye examination pre-operatively, including funduscopy with assessment of a~     Weiss ring and optical coherence tomography (OCT). Patients will be divided into two groups,~     group A with pre-operative complete PVD and group B with no/partial PVD. Group A will be~     invited for one follow-up visit (two months post-operatively) followed up by telephone~     interviews at one, two, three and five years after surgery to determine occurrence of~     pseudophakic retinal detachment. Group B will be invited for follow -up examinations at two~     months, six months and one year after surgery to document occurrence of PVD (if a PVD is~     present at one of the follow-ups, no more visits are necessary). Two, three and five years~     after surgery, all patients from group B will be interviewed by telephone, as in group A, to~     document the occurrence of pseudophakic retinal detachment.~      In the recent literature the association between the occurrence of PVD pre-/post-operative~     and RD after lens surgery is well documented but not described for myopic patients. The~     results of this multicenter study should help to tackle the problem of RD prediction in~     myopic patients depending on their pre-operative vitreous status, especially in the setting~     of refractive lens exchange.~   "
31655|NCT03152734|"~     The POSE study will predict critical stages and outcome in a large sample of all surgical and~     non-surgical interventional patients ≥80 years of age in Europe.~   "
31656|NCT03152721|"~     With time most people with Parkinson's disease (PwP) develop fluctuations in motor symptoms~     in relation to medication intake. The prevalence may be both under and overestimated as it is~     based on history rather than observation. Patterns in fluctuations are difficult to determine~     and it has been demonstrated that every 30-minute diaries need to be kept for 10 days or more~     to safely represent fluctuation patterns. The Parkinson Kinetigraph (PKG) is an automated~     system that is carried passively and provides similar information after wearing the device~     for 6 days. Clinical experience is that most patients agree that results are representative~     to their experiences. It is not known if using the PKG routinely at any stage of PD will~     change management of the disease. The hypothesis of this study is that providing PKG~     information to neurologists will lead to a more active management that may improve outcome in~     PD patients.~   "
31657|NCT03152708|"~     This study was conducted on the post-operative tumor tissues from 62 GBM patients. 20 slices~     are necessary for all the CD95 and CpG2 test in the central lab by the methods of~     immunisation and DNA methylation.~   "
31658|NCT03152695|"~     High-intensity focused ultrasound (HIFU), a recently developed tumor ablation equipment, can~     be a non-invasive treatment for solid tumors. The principle of HIFU is physically focus the~     ultrasound point on the biological tissue to form high-intensity ultrasound focus, and kill~     tumor cells by the thermal effects, mechanical effects and acupuncture effects of the~     high-intensity ultrasound.~   "
31659|NCT03152682|"~     A crossover design to evaluate the safety and efficacy of GoodIdea TM (trademark) on glucose~     homeostasis in a healthy population. Eligible participants will be given either the GoodIdea~     drink or placebo and a standardized meal and will consume both in approximately 15 minutes.~     Blood will be drawn at several time points over a 3 hour period to determine the study~     objectives. After a 7-day washout, the participants will come back to the clinic and and~     complete the visit consuming the opposite product given at the previous visit. The primary~     objective is to see the difference of the two-hour iAUC for intravenous blood glucose between~     the active product (GoodIdea) and the placebo following a standardized meal.~   "
31660|NCT03152669|"~     The Salford Lung Study (SLS) subjects represent a group of COPD and asthma patients whose~     disease is extremely well-characterised over a short time period. Subjects in the SLS~     originally consented for information relevant to the study to be shared with the sponsor~     (GSK). These data were limited to three years prior to randomisation and the twelve-month~     interventional treatment period. Broadened access to patients' data would allow SLS subjects'~     entire disease journey to be researched, presenting a rare opportunity to improve scientific~     and clinical understanding of COPD/asthma disease risk, treatment and progression. This~     proposal seeks to collect additional subject-level data from SLS patients via their~     electronic medical records (encompassing past and future data for up to 10 years from the~     date of consent) and via a one-off patient questionnaire administered at the time of consent.~   "
31661|NCT03152656|"~     Familial hypercholesterolemia (FH) is an inherited disorder of lipoprotein metabolism,~     transmitted in an autosomal dominant manner and clinically characterized by elevated levels~     of total cholesterol (TC) and low-density lipoprotein (LDL) cholesterol, the presence of~     tendon xanthomas, and premature atherosclerosis.~      The homozygous form of familial hypercholesterolemia (HoFH) with autosomal dominant~     transmission, in which case both alleles of either LDLR, APOB, or PCSK9 gene are defective,~     is a rare genetic disorder with prevalence estimated to be one per million population.~      Large scale genetic screening for active FH cases finding has been performed in the~     Netherlands, Spain, Norway and Wales. However, the FH population and prevalence in Taiwan~     have never been formally studied. Patients are usually not under appropriate treatment owing~     to lack of standardized diagnostic tool and treatment strategy for FH. Moreover, with the~     emerging of new classes of LLTs, including microsomal triglyceride transfer protein (MTP)~     inhibitor, antisense oligonucleotide inhibitor, and PCSK9 inhibitors, even homozygous FH~     patients now have better chance to be treated to reach recommended treatment goals.~     Therefore, A National FH registry is needed to collect contemporary data on diagnosis,~     treatment and outcomes with long- term goals of improving diagnosis, management, and~     reduction of unnecessary cardiovascular events in FH population in Taiwan.~   "
31662|NCT03152643|"~     The aim of this RCT is to compare differences in the efficacy and safety between~     cleavage-stage embryo transfer and blastocyst-stage embryo transfer in IVF/ICSI treatment~     cycle, taking into account of subsequent vitrified embryo transfers. Subjects with 4 or more~     transferrable cleavage embryos will be randomized to the cleavage-stage or blastocyst-stage~     embryos transfer group. The primary outcome is cumulative live birth rate (CLBR) per patient~     until the first live birth from one initiated oocyte retrieval cycle.~   "
31663|NCT03152630|"~     Around 10% of stroke survivors develop dementia within 3 months after stroke and over 20%~     more stroke patients have dementia in the subsequent 3 years. Previous studies documented a~     close relationship between stroke and Alzheimer's disease (AD). There are, however, no~     reliable biomarkers to detect cognitive dysfunction and dementia among stroke patients or to~     predict the risks of vascular dementia (VD) and AD among patients with stroke. There is a~     clear need to identify novel mediators of cognitive dysfunction in stroke patients to provide~     insights into the pathogenesis, to tailor clinical care based on risks, and to develop new~     therapeutic strategies.~      While the expression of messenger RNAs (mRNAs) and microRNAs (miRNAs) account for only ~1% of~     all transcribed species, up to 90% of the mammalian genome is transcribed as long non-coding~     RNAs (lncRNAs), a heterogeneous group of non-coding transcripts longer than 200 nucleotides.~     LncRNAs have been shown to be functional and involved in specific physiological and~     pathological processes through epigenetic, transcriptional and post-transcriptional~     mechanisms. While the roles of lncRNAs in human diseases including cancer and~     neurodegenerative disorders are beginning to emerge, it remains unclear how lncRNA regulation~     contributes to cognitive dysfunction and dementia in stroke patients.~      In this proposal, we seek to apply next-generation sequencing technology to investigate~     circulating lncRNA expression, as well as exosomal RNAs in the subjects with and without~     cognitive dysfunction or dementia. In addition, we will apply the near-infrared spectroscopy~     (NIRS) to evaluate cerebral blood flow, metabolism and oxygenation in these subjects. We will~     test the hypothesis that circulating lncRNA/exosomal RNA signature and NIRS imagaing can~     reflect the cognitive states in stroke patients. The accuracy, sensitivity and specificity of~     the lncRNA-exosomal RNA-NIRS-based cognitive dysfunction scoring system will then be tested~     in an independent, large validation cohort. Next, we propose to test the hypothesis that~     circulating lncRNAs/exosomal RNA and NIRS imaging can be novel prognostic biomarkers to~     predict cognitive dysfunction and dementia in stroke patients. These studies will also~     establish a set of novel, lncRNA-based diagnostic and prognostic biomarker in stroke patients~     to improve clinical preventive and therapeutic care.~   "
31664|NCT03152617|"~     Weight-reducing obesity surgery (OS) generally gives good results but complications are~     common; e.g. impaired weight loss, weight regain, bowel pain, diarrhea, vitamin/mineral~     deficiency, osteoporosis and impaired dental health. The BASUN study is a prospective 10-year~     comparison of 1000 surgically and 400 conventionally treated individuals regarding adverse~     side-effects, risk factors for complications and poor outcome.~   "
31665|NCT03152604|"~     Persistent pain (PP) affects many people worldwide. Patient Education is central to good~     management. Pain neurophysiology education (PNE) is a new form of education. It aims to help~     patients 'reconceptualise' their understanding of pain away from the perception that PP is an~     indicator of tissue damage, to PP is due to a sensitised nervous system. This perception is~     considered a less threatening and more conducive to rehabilitation. There is a growing body~     of evidence supporting its effectiveness. One unpublished Australian study combined PNE with~     a pain management program and found significant beneficial effects. However, there is a need~     to test this intervention rigorously under randomised controlled trial conditions to inform~     clinical practice. The Medical Research Council state that during the development and~     evaluation of a complex intervention (in this case a PNE informed PMP), it is important to~     undertake feasibility work, to investigate the components of randomised controlled trial~     (RCT) methodology prior to a full scale trial. The overarching aim of this mixed-methods~     study is to develop a feasible research protocol for a RCT investigating the efficacy of a~     pain neurophysiology education informed pain management programme. In this feasibility study,~     participants with PP will be assessed before and after a PNE informed pain management program~     that they are due to receive as part of their usual care. In the week before the programme~     participants will attend Teesside University (TU) where they will complete a battery of~     outcome measures. A subsample of participants will also undergo a semi-structured interview.~     In the week following completion of their usual care PMP participants will once again attend~     TU where they will complete the same outcome measures and the same subsample of participants~     will undergo a second semi-structured interview. At this point participants will have~     completed the study.~   "
31666|NCT03152591|"~     The purpose of the study is to evaluate whether LIK066 can be developed for the treatment of~     polycystic ovary syndrome (PCOS) in overweight and obese women.~   "
31667|NCT03152578|"~     This study consists of a randomized, double-blind, placebo-controlled crossover trial with~     open label extension evaluating a topical natural health cream containing ß-caryophyllene~     alone and in combination with 0.025% capsicum oleoresin against placebo. At the end of the~     randomized controlled phase of the trial all participants will be given open-label~     combination cream to be administered over the subsequent 3 weeks.~      Primary Endpoint: Evaluation of improvement in pain interference as measured by the BPI in~     individuals who are experiencing pain due to osteoarthritis of the knee.~      Secondary Endpoints: Secondary endpoints are: Confirmation of safety of the topical cream~     when used daily over 10 weeks.~      Further evaluation will include overall patient satisfaction with the products tested.~   "
31670|NCT03152539|"~     The main objective of the studies that will be carried out on volunteer patients who have~     given their consent will be the development and optimization of the sequence parameters or~     the design of the stimulation paradigms in order to optimize the quality and Relevance of the~     images realized taking into account anatomical, functional or metabolic parameters. These~     adjustments will be carried out without interfering with the management of voluntary patients~   "
31671|NCT03152526|"~     This is a phase II trial designed to test the safety and efficacy (complete response [CR]) of~     related donor HLA-haploidentical NK-cell based therapy for the treatment of acute myelogenous~     leukemia (AML).~      Patients with newly diagnosed AML who failed to achieve a complete remission (CR) after one~     or two standard induction attempts receive after a preparative regimen of cyclophosphamide~     and fludarabine a single infusion of CD3-/CD19- NK cells or CD3-/CD56+ NK cells followed by a~     short course of Interleukin-2 (IL-2) to facilitate NK cell survival and expansion.~   "
31672|NCT03152513|"~     The objective of this study is to look at critical events in the pediatric operating room in~     a retrospective and now prospective fashion to determine if there are any trends such as age,~     presence of URI, type of surgery, type of airway, level of hands on provider, or other~     predictive markers associated these events so that we may gain some insight into perhaps~     reducing the incidence of these events or simply be more attune to the increased risks in~     certain situations.~   "
31673|NCT03152500|"~     In this study the investigators will investigate the stability of lens position and the~     visual outcome after implantation of the new FEMTIS-IOL using FLACS capsulotomy compared to~     conventional placement of the IOL in the capsular bag. So far, there are no published studies~     using the FEMTIS-IOL. Therefore, the investigators will perform this randomized control~     trial.~   "
31674|NCT03152487|"~     Pancreatic cancer is the second most common gastrointestinal malignancy. Abdominal discomfort~     is a main symptom in patients with pancreatic cancer. Approximately 75% have pain at~     diagnosis and over 90% in advanced stages. Pain control is an important part of the plan of~     care for patients with pancreatic cancer.. The celiac plexus is a group of nerves that supply~     organs in the abdomen. EUS-guided celiac plexus neurolysis (EUS-CPN) has been widely used for~     pain management in patients with pancreatic cancer. Radiofrequency ablation of celiac ganglia~     or celiac plexus (EUS-RFA) is also being performed to alleviate abdominal pain in pancreatic~     cancer patients. However currently no comparative studies exist comparing EUS-CPN with~     EUS-RFA. The purpose of the study is to compare EUS-CPN with EUS-RFA for pain management in~     pancreatic patients, in order to determine which technique is better at improving pain in~     pancreatic cancer patients.~   "
31675|NCT03152474|"~     The study involves the participant to receive a 250 mcg Cortrosyn (ACTH) Stimulation Test to~     test the ability of the body to make Cortisol. If the body is not able to make large amount~     of Cortisol (Delta Cortisol < 13 mg/dl) from the stimulation test, then the participant will~     be given additional cortisol like medicine called Solumedrol or matching placebo.~      If the body is able to make large amounts of Cortisol (> 13 mg/dl), then the participant will~     receive daily shots of Vitamin A for 7 days or matching placebo.~      If the participant does not respond to the stimulation test, and meets the criteria for~     Cortisol deficiency (all 3 cortisol concentrations < 20 mg/dl), then he/she will screen~     failed for the study and will be offered hydrocortisone as part of routine care by the~     treating physician.~   "
31676|NCT03152461|"~     This study will evaluate the performance of the Quantra System comprised of the Quantra~     Hemostasis Analyzer with the Quantra Surgical Cartridge in patients undergoing major surgical~     procedures specifically, major cardiac and vascular procedures and major orthopedic surgery~     (primarily complex spine surgeries).~   "
31677|NCT03152448|"~     This is a prospective study to measure the impact on first-line therapy of genomic testing of~     biopsy tissue from recently diagnosed treatment-naïve patients with early stage localized~     prostate cancer.~   "
31678|NCT03152435|"~     This is a clinical study to observe the maximum tolerated dose (MTD) and the safety and~     feasibility of chimeric antigen receptor EGFR (EGFR CART) cells in metastatic patients with~     colorectal cancer.~   "
31679|NCT03152422|"~     uPROPHET aims to validate urinary proteomics for risk stratification and monitoring graft~     performance is recipients of heart transplants~   "
31680|NCT03152409|"~     The investigators are doing this research study to find out if using aspirin along with~     antidepressant treatment can lessen symptoms of depression. This study also aims to find out~     if some people improve more from taking aspirin than others. The investigators also want to~     see if it is possible to predict which participants will do better based on a blood test.~      Aspirin is approved by the U.S. Food and Drug Administration (FDA) as an over-the-counter~     pain medication. But, aspirin is not approved by the FDA to make antidepressant treatment~     better.~      This research study will compare aspirin to placebo.~   "
31681|NCT03152396|"~     Cardiovascular disease (CVD) (disease of the heart and blood vessels) is one of the leading~     causes of death and disability in Canada today. The majority of CVD cases are caused by~     factors that can be controlled. These factors include tobacco use, obesity, high blood~     pressure, high cholesterol, diabetes, and physical inactivity. Such factors are common and~     not well controlled. Inflammatory arthritis (IA) (Inflammation of the joints and other~     tissues) is considered another risk factor or CVD. As such, people who have IA and any of the~     previously mentioned risk factors would be at high risk for developing CVD. Controlling these~     factors will bring down the risk of having cardiovascular disease and make the quality of the~     individuals' life better. Pharmacists work with patients and their family doctors to provide~     cardiovascular care. Having a pharmacist involved in the care process may help patients with~     IA reduce their CV risk. Pharmacists are easier to reach and may have more opportunities to~     educate people about medications. This might lead to better prevention and control of~     cardiovascular diseases.~   "
31696|NCT03152201|"~     During surgery, electrophysiological signals will be acquired with the instrument (ISIS IOM,~     NeuroExplore, Software Version 4.4, Inomed) already in use at the Neurosurgery Service of the~     Neurocentro of the Hospital Civic Italian Switzerland in Lugano. Simultaneously to~     Somatosensorial Evoked Potential (SEP) will also be recorded the Electroencephalography (EEG)~     activity with the same detection of locations.~      For the purposes of the study the signals transmitted to the neurosurgeon through the~     hardware and the corresponding assessments done by the neurophysiologist responsible for~     intraoperative monitoring will be recorded. It will also be kept track of procedures~     performed during surgery.~   "
31682|NCT03152383|"~     The purpose of this study is to compare how children with autism, typically developing~     children, and children with other developmental delays value social attention and toys. The~     first part of the study seeks to determine whether breakpoints when responding on progressive~     ratio (PR) schedules can be used to determine the value of leisure items and attention. By~     comparing the breakpoints obtained for leisure items and attention, the researchers will~     determine the differential valuation of leisure items and attention. It is anticipated that~     the manner in which individuals with an autism spectrum disorder (ASD) diagnosis and those~     who do not will differ with respect to the degree to which they value these two types of~     stimuli. The second part of the study seeks to determine whether an intervention in which~     social attention is paired with primary reinforcers impacts responding during the PR~     assessment, in children with ASD.~   "
31683|NCT03152370|"~     This is a multicenter, open-label, Phase 1b study in participants with locally advanced~     rectum cancer where primary resection without chemoradiotherapy is unlikely to achieve clear~     margins as defined by magnetic resonance imaging (MRI). It is conducted to assess the safety,~     to assess the tolerability, and to determine the recommended Phase 2 dose (RP2D) of E7046 in~     combination with pre-operative chemoradiotherapy. The study will also assess the efficacy of~     the combination in the expansion part at RP2D.~   "
31684|NCT03152357|"~     This study is designed to evaluate implant survivorship, patient satisfaction, and~     patient-reported outcomes of subjects who have undergone surgery with any of the following~     ConforMIS knee implants: the iUni®, iDuo® or iTotal® Cruciate Retaining (CR) Knee Replacement~     Systems.~   "
31685|NCT03152344|"~     The risk of falling in increased in patients with Chronic Obstructive Pulmonary Disease. To~     date, a screening test (the Berg Balance scale, BBS) is used to evaluate this risk but it~     spends 20 to 30 minutes to complete.~      The aim of our study is to evaluate the sensitivity of a more straightforward test (Timed Up~     and Go, TUG)) to assess the fall risk. The TUG is routinely used in elderly to screen for~     frailty.~   "
31686|NCT03152331|"~     The purpose of this study is to evaluate a model of mindfulness and neurofeedback among~     physicians and nurses. Several hypotheses will be tested: 1) BIS values will decrease as the~     number of sessions increase, 2) wellbeing scores will increase as the number of learning~     sessions increase, 3) wellbeing scores will be associated with BIS values, and 4) different~     attentional states will have more or less influence on reducing the BIS value.~   "
31687|NCT03152318|"~     This research study is evaluating an investigational drug, an oncolytic virus called~     rQNestin34.5v.2. This research study is a Phase I clinical trial, which tests the safety of~     an investigational drug and also tries to define the appropriate dose of the investigational~     drug as a possible treatment for this diagnosis of recurrent or progressive brain tumor.~   "
31688|NCT03152305|"~     An increase in intracranial pressure (ICP) during migraine attacks is possible and could~     contribute to pain initiation and maintenance. From now on, it was not possible to measure~     ICP in a non-invasive way. The development of a new tool allows non-invasive self-measures of~     ICP variations. Thus, it is possible for the first time to look for such ICP variations~     during migraine attacks and to conclude if this mechanism is implied in the pathophysiology~     of migraine.~   "
31689|NCT03152292|"~     To examine the current disease progression of PDP, the clinical, economic, and humanistic~     impact of anti-psychotic therapy in the management of the condition in real-world settings,~     and the burden of the condition on patients and their caregivers~   "
31690|NCT03152279|"~     Increased intestinal permeability can represent compromise of the epithelium's integrity and~     is thought to be the primary mechanism in patients who develop Celiac Disease (CeD) and~     non-celiac gluten sensitivity when gluten peptides cross the barrier and trigger an immune~     response. In this study, the investigators propose to use a novel, minimally invasive~     technology to detect mucosal damage (i.e. barrier dysfunction) in the duodenal epithelium.~     The primary aim of this study is to identify if there is a difference in duodenal mucosal~     impedance between CeD and control patients.~   "
31691|NCT03152266|"~     Is the anatomical reduction of osteochondral impaction in the acetabular fractures will~     improve the functional outcome? Despite the increasing amount of literature related to the~     management of anteromedial dome impactions and marginal impactions, there are still remaining~     issues and controversies pertaining mainly to the exact anatomy and location of the lesion,~     the best method of reduction, the need and type of subchondral void filling, the best method~     of stabilization, the need of reduction in elderly population and its true value as an~     outcome prognostic factor.~   "
31692|NCT03152253|"~     This study will continue development of a quit smoking program delivered through text~     messaging. Upon completion of programming we will enroll 280 participants and randomize them~     to a control condition or the intervention condition. Assessments will occur at enrollment,~     and both 3 and 6 month follow ups.~   "
31693|NCT03152240|"~     TAPAC study is an an investigator-driven, observational, prospective,cohort aimed at~     evaluating differences between men and women in patients undergoing primary angioplasty :~     hospital medical care, successful markers myocardial reperfusion and the anatomical substrate~     by describing the underlying coronary anatomy will be compared.~   "
31694|NCT03152227|"~     This study aims at evaluating the impact of integrating nutrition sensitive behavioral change~     communication (BCC) in the context of increased household production of chicken and eggs on~     women and children diet.~   "
31695|NCT03152214|"~     Over 2 million soldiers have deployed during the Operation Enduring Freedom (OEF) and~     Operation Iraqi Freedom (OIF) conflicts. While the majority of veterans reintegrate~     successfully following deployment, a sizable minority return and face difficulties~     transitioning into civilian life. There is surprisingly little research on disseminable~     programs to facilitate reintegration, particularly outside of the formal VA healthcare~     system. The primary objective of this project is to develop and evaluate an integrated~     community- and exercise-based program that can be prescribed to augment existing transition~     assistance programs.~   "
31697|NCT03152188|"~     To evaluate the safety and tolerability of oral fecal transplant in patients with cirrhosis~     and hepatic encephalopathy~   "
32093|NCT03146949|"~     This study compares two oxygenators commonly in use to establish whether they effect the~     amount of isoflurane in the patient's blood. Half of the patients will be placed in a group~     using the Sorin Inspire oxygenator and half into the group using the Medtronic Affinity~     Fusion oxygenator.~   "
31698|NCT03152175|"~     Police officers, correctional service officers, and 911-operators are at increased risk for~     suffering from trauma-related disorders due to their direct and indirect exposure to~     life-threatening events, such as shootings, violent assaults, or car accidents, among others.~     Typical treatments for post-traumatic stress disorders include psychotherapy and~     pharmacological therapies (i.e., antidepressants). Although these interventions are effective~     for many sufferers, they all have limitations. Thus, the investigators propose to explore the~     usefulness of a new therapeutic technique, reconsolidation blockade, which involves~     reactivating the trauma memory while under the influence of propranolol. Objectives and~     hypotheses: To explore the efficacy and cost-effectiveness of reconsolidation blockade~     therapy as an adjunct treatment for trauma- and stressor-related disorders as defined in the~     Diagnostic and Statistical Manual Mental Disorders-5. The investigators hypothesize that,~     compared to the control group, 5 weekly trauma-memory reactivations under propranolol~     treatment will confer a significant reduction in trauma-related symptoms and significantly~     more health-related economic benefits. Stress symptoms and health-related costs will be~     assessed at 7, 26 and 52 weeks after study inclusion. In this study, the investigators will~     also explore the effects of reconsolidation blockade with propranolol on various~     neuropsychological functions.~   "
31699|NCT03152162|"~     This is a prospective clinical study designed to observe the long-term clinical outcomes of~     total knee arthroplasty using a patient-specific, posterior stabilized implant in patients~     with osteoarthritis.~   "
31700|NCT03152149|"~     This protocol describes a randomised controlled trial to test the hypothesis that 6 months of~     treatment with tiotropium and olodaterol will result in a reduction in bacterial load, an~     improvement in neutrophilic inflammation and clinical benefits compared with treatment with~     inhaled fluticasone furoate and vilanterol in patients with neutrophilic Chronic obstructive~     pulmonary disease (COPD).~      COPD is the third leading cause of death worldwide and a major cause of morbidity in the UK.~     Exacerbations drive disease progression and worsening quality of life and therefore~     prevention of exacerbations has been a major goal of treatment.~      In recent years, attempts have been made to phenotype COPD patients in order to target~     therapies to the correct groups of patients that will benefit. Inhaled corticosteroids (ICS)~     are primarily effective for patients with eosinophilic inflammation, while there are few~     established therapies for patients with neutrophilic disease. In recent years, all ICS~     preparations have been associated with a significant increased risk of pneumonia and this~     risk appears to be greatest in patients with non-eosinophilic inflammation. Combined~     treatment with long acting beta-agonists (LABA) and long acting muscarinic antagonists (LAMA)~     combinations appears to be a safer and more effective alternative for patients with~     non-eosinophilic disease. The combination of tiotropium and olodaterol in particular, has~     strong preclinical data supporting beneficial effects on neutrophilic inflammation.~      The trial is a multi-centre randomised open label controlled parallel group study with two~     treatment arms in 80 participants. Moderate to very severe COPD patients and currently~     treated with inhaled corticosteroid therapy will be randomised to treatment with either the~     combination of tiotropium and olodaterol (LABA/LAMA) or fluticasone furoate and vilanterol~     (ICS/LABA). Participants will return at 1 month, 2 months, 3 months and 6 months for sampling~     of the lower airway by sputum samples and the upper airway using oropharyngeal and~     nasopharyngeal swabs. Sputum will be used to test for airway neutrophilic inflammation.~      This study will make an important contribution to understanding phenotyping in COPD by~     identifying whether the combination of tiotropium and olodaterol improves airway bacterial~     load and restores neutrophil function in patients with neutrophilic COPD.~   "
31701|NCT03152136|"~     Prospective, multi-center, randomized, controlled study designed to evaluate safety and~     repeatable effectiveness. Subjects will be randomized 2:1:1 to transcutaneous afferent~     patterned stimulation (TAPS), sham, or 'no intervention', respectively. Subjects randomized~     to the TAPS and sham arms will be blinded to their randomization assignments for the first~     two weeks of participation (controlled phase). After the first two weeks, all subjects will~     be crossed over to TAPS (open-label phase) for 2 weeks. During study participation, all~     subjects are to remain on a stable dosage of medications prescribed for the treatment of~     essential tremor, if applicable.~   "
31702|NCT03152123|"~     The purpose of this study is to assess the abuse potential of single doses of pitolisant~     relative to phentermine HCl and placebo, when administered to healthy, non-dependent,~     recreational stimulant users.~   "
31703|NCT03152110|"~     Objectives: Spinal cord injury (SCI) is debilitating to an individual's health and functional~     capacity and can significantly reduce quality of life. Specifically, SCI contributes to a~     sedentary lifestyle and a subsequent elevated risk for preventable cardiometabolic and~     hypokinetic diseases. While physical activity is strongly promoted in persons with SCI as a~     means to reduce the incidence and development of secondary disabling conditions, a majority~     of individuals with SCI are inactive and have low levels of fitness. High intensity interval~     training (HIIT) is a form of exercise that is characterized by brief, intermittent bouts of~     intense exercise, separated by periods of lower intensity exercise for recovery. The~     magnitude of improvements in aerobic exercise capacity and other key cardiometabolic risk~     factors following HIIT are similar to moderate-intensity continuous training, but only~     require a fraction of the total energy expenditure and a vastly reduced time commitment.~     Little research has been conducted on HIIT in persons with SCI, who are unique from other~     special population groups due to their inability to carry out conventional lower limb HIIT~     exercises. An upper extremity form of HIIT that is effective, safe, quick and has acceptable~     positive affect could be an attractive option for persons with SCI who are not presently~     exercising and have low fitness levels. The study will look at feasibility and acceptability~     of a 6-week HIIT program for persons with a spinal cord injury who are untrained.~      Methods: Investigators aim to test 10 individuals with spinal cord injury/dysfunction who are~     untrained and use a manual wheelchair full time for mobility. Prior to starting any testing~     or exercising, participants will be screened and will need to obtain a signed medical release~     form from their physician. The screening procedure will include asking the participant the~     inclusion/exclusion criteria and administering two short questionnaires related to physical~     activity that will determine eligibility for the study. After obtaining the release form,~     participants will be scheduled for their first visit. During Visit 1, participants will~     complete baseline exercise testing and questionnaires. The study questionnaires will include~     questionnaires related to sociodemographics, pain and health measures, general health and~     function, and physical activity. Exercise testing includes an aerobic exercise stress test~     (conducted following American College of Sports Medicine guidelines using an electronic~     ergometer) and an anaerobic (maximum power output) test. After Visit 1, participants will~     exercise three times per week for six weeks, following a standard HIIT protocol. Two of those~     sessions will be supervised by a trainer, and one session will be completed on their own.~     After the six week time period, participants will be scheduled for Visit 2 and will complete~     the same evaluations as Visit 1. Additionally, participants will complete evaluations~     measuring the level of satisfaction of the training program and their likelihood of~     continuing the program.~   "
31704|NCT03152097|"~     The project will investigate the modulation of flavin-containing monooxygenase (FMO)~     formation of the CVD risk factor trimethylamine-N-oxide (TMAO) in patients with kidney~     disease.~   "
31705|NCT03152084|"~     The purpose of this study is to evaluate how dapagliflozin mechanism of action is impacted by~     Type 2 Diabetes Mellitus status and kidney function.~   "
31706|NCT03152071|"~     In this study the investigator will compare the effectiveness of robot assisted thoracic~     surgery (RATS) with video assisted thoracic surgery (VATS) in case of lung cancer.~      The perioperative circumstances and postoperative outcome will be compared.~   "
31707|NCT03152058|"~     This treatment trial evaluates the addition of an anti-tumor necrosis factor-alpha drug,~     certolizumab, to usual treatment (a heparin agent and low-dose aspirin) in pregnant women~     with antiphospholipid syndrome (APS) and repeatedly positive tests for lupus anticoagulant~     (LAC) to determine if this regimen will improve pregnancy outcomes. All enrolled patients~     will receive certolizumab, and pregnancy outcomes will be compared to those of women with APS~     and repeatedly positive tests for LAC enrolled in a previous study by the investigators.~   "
31708|NCT03152045|"~     The purpose of this pilot study is to evaluate the feasibility, acceptability, and~     preliminary efficacy of an intervention aimed at improving how adolescent patients and their~     clinicians communicate about behavior change.~   "
31709|NCT03152032|"~     This multicenter retrospective cohort study examined the employment outcomes of the~     innovative in-house vocational training (IHVT) programs for individuals with chronic~     psychiatric disorders (CPD) and explored the program parameters significantly predictive of~     the outcomes. The IHVT programs were government-funded services offered to newly discharged~     inpatients or current outpatients with chronic psychiatric disorders (CPD) in four regional~     psychiatric hospitals of Taiwan. Each program was staffed with occupational therapists and~     paid or volunteer job coaches, along with cross-disciplinary support from psychiatrists,~     psychologists, social workers, nurses, vocational specialists or others. Data were retrieved~     from 323 participants with CPD who completed the IHVT and the 1st-, 3rd-, and 6th-month~     follow-up interviews. The employment outcomes examined were the participants' employment~     rates at the 1st-, 3rd-, and 6th-month post-training as well as their sustainability of~     employment during the 6 months post-training.~   "
31734|NCT03151707|"~     The primary aim of this study is to investigate the effects of exogenously administered~     nicotinamide riboside (NR) on brain NAD+/NADH ratio and bioenergetics functions in healthy~     individuals using phosphorus magnetic resonance spectroscopy (31P MRS) imaging.~      The secondary aim is to investigate the effects of NR on brain structure and neurotransmitter~     functions using other neuroimaging methods.~   "
31710|NCT03152019|"~     The recognized manifestations of HHT are all due to abnormalities in vascular structure.~     Epistaxis due to telangiectases formation is spontaneous, very variable, recurrent in 90% of~     patients, and associated with severe anemia in 2-10%. They also significantly reduce quality~     of life.~      Improvement in epistaxis has been shown in HHT patients after a liver transplantation. It was~     hypothesized that the immunosuppressive treatment (FK506) used to prevent rejection may have~     an anti-angiogenic effect.~      The results of Albiñana et al suggest that the mechanism of action of FK506 involves a~     partial correction of endoglin and ALK1 haplosufficiency, genes responsible for 90% of HHT~     case.~      Tacrolimus ointment is available on the market for the treatment of eczema and can therefore~     readily be used as it is for nasal administration. Topical nasal administration of tacrolimus~     may be an easy local ENT treatment that is non-aggressive and results in little trauma for~     the patient in relation to other first line treatment possibilities.~      The main objective of this trial is to evaluate, at 6 weeks after the end of the treatment,~     the efficacy on the duration of nosebleeds, of 6 weeks tacrolimus nasal ointment application,~     in patients with HHT complicated by nosebleeds (30 min/6 weeks). Secondary objectives are to~     evaluate the tolerance throughout the study, the efficacy on anemia and on clinical~     parameters (nosebleeds, quality of life, epistaxis severity score questionnaire and blood~     transfusions) and the systemic absorption of nasal administration.~      This is a multicenter prospective and double blinded phase I/II trial. A total of 48 patients~     will be randomized versus placebo using an allocation ratio of 1:1. The ointment (Protopic®~     at 0.1% or placebo) will be self-administered by the patient with one administration in each~     nostril twice a day for 6 consecutive weeks.~   "
31711|NCT03152006|"~     The purpose of this study is to evaluate the comparative effectiveness of a comprehensive,~     coordinated transition protocol which includes an early introduction to the adult provider,~     an integrated case management team and a peer-facilitated organized support group on~     retention in care, viral suppression and psychosocial wellbeing among adolescents living with~     HIV.~   "
31712|NCT03151993|"~     The aim of the study is to determine if single-bolus recombinant nonimmunogenic~     staphylokinase is effective and save thrombolytic agent in with ischemic stroke in comparison~     to alteplase.~   "
31713|NCT03151980|"~     Hamam is a common spa treatment. During a Hamam, some of the outermost layer of the skin is~     removed. The investigators believe that partly removing a protective skin layer might~     increase the risk of sun burn, especially for skin that has not been exposed to sun for a~     long time.~      The aim with this study is to assess if Hamam-treated skin is more susceptible to sun burn~     compared with untreated skin.~   "
31714|NCT03151967|"~     The purpose of this research is to see whether LACTIN-V (Lactobacillus crispatus CTV-05) is~     an effective method of preventing recurrent urinary tract infections (UTI's) and to learn the~     side effects of LACTIN-V. LACTIN-V is a vaginal applicator that contains Lactobacillus~     crispatus, an organism found naturally in the vaginas of healthy women. Lactobacillus~     bacteria are thought to help prevent other bacteria such as E. coli from causing UTI's. This~     is a double blind study comparing active product to a placebo (inactive vaginal applicator~     without any medicine).~   "
31715|NCT03151954|"~     Hippo-YAP pathway is a newly discovered pathway controlling the growth, and plays important~     roles in the regulation of stem cell function and tissue regeneration. Previously we found~     that a higher expression of YAP in NP, and LPS was able to activate the hippo-YAP pathway in~     NESCs. Thus, we hypothesize that the aberrant proliferation and differentiation of NESCs~     could be regulated via the hippo-YAP pathway.~   "
31716|NCT03151941|"~     The methodology is a feasibility study to determine the feasibility of assessing people in~     the community with a neurological condition before proceeding towards a full powered~     community trial evaluating the influence of intrathecal baclofen.~   "
31717|NCT03151928|"~     The validation study is intended to provide comparative data on the diagnosis of vaginal~     infections as performed in primary care settings versus the diagnosis provided through~     standard diagnostic testing performed in a reference laboratory. The clinician and lab~     diagnoses will be compared to those obtained using the BD MAX Vaginal Panel on the BD MAX~     System.~   "
31718|NCT03151915|"~     Twin-twin transfusion syndrome is one of the most severe complication in monochorionic twin~     pregnancies and can cause severe impairment of fetal and neonatal outcome. In severe TTTS the~     fetoscopic laser coagulation is the treatment of choice. Fetoscopic laser coagulation is~     associated with a morbidity and mortality due to iatronic rupture of membranes as well as~     iatrogenic placenta insufficiency. This can cause preterm delivery as well as intrauterine~     fetal demise. An adaption of the fetoscopic tools to reduce the lesions of the amniotic~     membrane can decrease the risk of PPROM and increase the overall survival.~   "
31719|NCT03151902|"~     Blood samples from urticaria patients will be analyzed for viral particles~   "
31720|NCT03151889|"~     Currently, cancer is a disease of high incidence, already considered a public health problem.~     Among the most prevalent are head and neck neoplasms, and depending on the location and~     extent of the lesion, the treatments are surgery, chemotherapy and / or radiotherapy that~     have a great impact on the quality of life. Radiation therapy is a frequently chosen~     treatment, and depending on the dose of radiation, causes changes such as hyposalivation.~     There are techniques for salivary flow stimulation, however, most of the options involve the~     use of medications, which limits administration to part of the patients. Transcutaneous~     electric nerve stimulation (TENS) is an alternative that has been used to stimulate salivary~     flow, however there is a limited number of studies that have tested this technique after~     radiotherapy. The aim of this study was to verify the effect of TENS in increasing the~     salivary flow of individuals receiving radiotherapy to treat tumors of the head and neck. The~     sample will have 80 patients randomly divided into two groups: TENS group and Control group.~     In both groups, a quality of life questionnaire (UW-QOL) will be applied and a~     speech-language assessment will be performed. The hypothesis of this research is that TENS is~     effective in increasing the amount of saliva. Secondary outcomes involve the evaluation of~     the effect of this technique on the quality of life, mainly in the questions: speech,~     chewing, saliva and deglutition.~   "
31721|NCT03151876|"~     The goal of this clinical research study is to evaluate effectiveness and safety of ChiCGB~     regimen( chidamide, cladribine, gemcitabine and busulfan).~      Busulfan are designed to kill cancer cells by binding to DNA (the genetic material of cells),~     which may cause cancer cells to die.~      Gemcitabine and cladribine are designed to disrupt the growth of cancer cells, which may~     cause cancer cells to die. It may help to increase the effect of busulfan on cancer cells by~     not allowing these cells to repair the DNA damage caused by busulfan.~      Chidamide is designed to open up the DNA and allow greater access to drugs that bind to DNA,~     such as cladribine, gemcitabine, busulfan.~   "
31722|NCT03151863|"~     Dexmedetomidine is allowed in Switzerland for intravenous (IV) medication in the intensive~     care unit in the adult patient. Its active molecule, Dexmedetomidine (Dex), is a selective~     and powerful α2-Adrenoreceptors (AR) agonist that shows the following complementary~     properties: anxiolytic, sedative and analgesic. Moreover, it displays interesting~     cardiovascular, respiratory and neuropsychic safety and tolerance profiles.~      There is increasing number of promising studies for the use of intranasal (IN) Dex in~     pediatric sedation due to its non-invasive nature, its efficiency and its rare secondary~     effects. However, there is currently no information in the literature on the use of IN Dex in~     elderly multi-medicated patients in palliative care.~      In this end-of-life population, pain is controlled with administration of opioids.~     Procedures, such as nursing cares, can generate pain and anxiety to the patient. Preventive~     analgesia, subcutaneous (SC) opioids, is administered before the care. However, most of the~     time, this additional dose fails to relieve the patient from his pain. In SPdol observational~     study, 42% daily hygiene and comfort nursing care remained painful despite the administration~     of a preventive analgesia.~      IN Dex seems to be a good candidate for non-invasive analgesia and sedation in patients~     admitted in palliative care before the nursing procedure.~      In this study, the investigators compare the efficiency of IN Dex to the regular extradose of~     SC opioids for analgesia before daily nursing care on elderly patients in the palliative care~     unit.~      The study design is a cross over, two-sided, superiority, double-blind, placebo-controlled~     and randomized clinical trial.~   "
31723|NCT03151850|"~     We analyzed the diversity of the fungal and bacterial within colon mucosa between patients~     with different degree of inflammation of Ulcerative Colitis.~   "
31724|NCT03151837|"~     This is a randomized, double-blind, placebo-controlled, add-on clinical trial to evaluate the~     efficacy and safety of Momordica Charantia extracts taken orally for 3 months by subjects~     with type 2 diabetes. A total of 40 subjects who meet the inclusion criteria and give written~     consent will be randomly assigned to (A) Momordica charantia extracts group (600mg/day), or~     (B) Placebo group (Starch 600mg/day) with 20 subjects for each group. Major enrollment~     criteria include: (1)Subjects have confirmed type 2 diabetes and fail to reach the treatment~     goal (fasting glucose 140-270mg/dL and hemoglobin A1c (HbA1c) 7-10%) after stable use of 1-3~     oral hypoglycemic drugs for 3 months; (2)Subjects have stable diabetes mellitus (DM) history~     with fasting glucose 140-270mg/dL and HbA1c 7-10% and refuse to use oral medications.~     Efficacy outcomes include the changes in fasting glucose, Hb1Ac, and insulin sensitivity, and~     safety assessments include liver and kidney function, and complains made by subjects after~     the initiation of the investigational products (IP).~   "
31725|NCT03151824|"~     Quality of life (QoL) is an important factor for successful aging. Telomere length is an~     indicator of cellular aging and cumulative biological stress and is thus related to health~     status and survival. However, the relationship between QoL and telomere length has not yet~     been examined. In this study we investigated the relationship between leukocyte telomere~     length (LTL) and QoL.~      However, the relationship between overall QoL and LTL has not previously been investigated.~     Therefore, this study was conducted to examine the relationship between LTL and QoL. QoL was~     measured by the Korean version of the 36-item short-form health survey (SF-36), which is a~     multidimensional scale consisting of subjective evaluation.~   "
31726|NCT03151811|"~     This is a randomized, controlled, open-label, Phase 3 multicenter study which will enroll~     patients with RRMM following 2-4 lines of prior therapy and who are refractory to~     lenalidomide in the last line of therapy as demonstrated by disease progression on or within~     60 days of completion of the last dose of lenalidomide. Patients will receive either~     melflufen+dex or pomalidomide+dex.~   "
31727|NCT03151798|"~     The study will investigate whether the level of fat stored in the liver is related to the~     liver's ability to burn fat.~   "
31728|NCT03151785|"~     60,000 people suffer an out of hospital cardiac arrest in the United Kingdom (UK) every year.~     Bystander cardiopulmonary resuscitation (CPR) rates are dismal (30%) compared with places~     where CPR education is mandatory for all school children (>50%). Strategies are needed to~     increase these rates through innovative approaches. Lifesaver (www.life-saver.org.uk) is an~     immersive interactive programme/application that presents such an opportunity. This study~     aims to assess the effectiveness of Lifesaver on CPR attitudes, knowledge, skills acquisition~     and retention in school children. Additionally, it aims to examine whether Lifesaver provides~     additional benefits in terms of CPR attitudes, knowledge, skills acquisitions and retention~     in school children when combined with face-to-face BLS training.~   "
31729|NCT03151772|"~     Neuro-oncological trials may fail due to the drug never getting to the intended target (i.e.~     within the tumor micro environment). Also, changes' occurring in tumor cells when removed~     from patients and grown in-vitro is another limiting factor influencing the clinical success.~      Important questions are therefore:~        1. Does the drug get there?~        2. Does the drug do what it is intended to do?~      To improve chances of clinical success there is a need for rational and intelligent selection~     of potential drugs in future trials. This is an initiative for analyzing tumor concentration~     of preoperative administered repurposed drugs~   "
31730|NCT03151759|"~     To analyse the effects of radiation therapy on inflammation and matrilysin levels in rectal~     cancer patients.~   "
31731|NCT03151746|"~     The study's objective is to determine the efficacy of preoperative gabapentin in relieving~     postoperative pain, reducing opioid use and improving quality of recovery in subjects~     undergoing urologic surgery.~      Investigators hypothesize that subjects receiving gabapentin will have lower pain scores,~     less opioid consumption and better quality of recovery as compared to subjects who are given~     a placebo.~   "
31732|NCT03151733|"~     Single incision laparoscopic surgery (SILS) is the further development of the concept of~     minimally invasive surgery for colorectal cancer,which rapidly developed in the field of~     colorectal surgery. Through the development of single hole laparoscopic colorectal cancer~     radical surgery and clinical study and follow up accordingly, evaluating the feasibility,~     surgical effectiveness and economy help to promote the popularization and application of~     single hole laparoscopic techniques in the field.~   "
31733|NCT03151720|"~     The purpose of this study is to establish the relative bioavailability of Xisimin~     (loratadine) compared to Clarityne in healthy participants receiving a single dose of 10~     milligram (mg) under fasting condition as part of Cohort 1 and under fed condition as part of~     Cohort 2.~   "
31735|NCT03151694|"~     This multi-national program applies a breakthrough approach to childhood obesity called,~     Brain-to-Society (BtS) Diagnostic Approach. In Montreal, Canada and Palwal, India, the~     investigators will recruit two cohorts of 612 children (6 to 12 years; 306 boy/306 girls)~     where Whole-of-Society (WoS) transformations are taking place (industrialized societal~     context with peaking childhood obesity and where a broad governmental plan to promote healthy~     lifestyle has been adopted -Canada; developing societal context with increasing childhood~     obesity if replication of past pathways that have lead to double burden; India) are taking~     place along with World Health Assembly (WHA) resolution A63-12 for marketing of food to~     children. Individual-level BtS Diagnostic will examine the degree to which individual~     differences in genetics and biology and differences in the environmental exposures modulate~     the behavioral, body weight/fatness and nutritional risk over time in the context of WoS~     transformations. Societal-level BtS Diagnostic shall examine the influence of decisions in~     policy, investment, business and innovation made by different stakeholders (government,~     private sector, civil society in health and non-health society systems including agriculture,~     business and media practices) on the community.~   "
31736|NCT03151681|"~     Attachment injuries are events occurring within couple relationships that involve betrayal or~     abandonment by a significant other during times of need (e.g., infidelity). They can be~     understood as relationship traumas, which can lead to debilitating symptoms consistent with~     posttraumatic stress disorder (PTSD), depression, and generalized anxiety for the injured~     partner. Research has demonstrated that the presence of an attachment injury represents a~     barrier to empirically effective couple's therapy. However, disrupting memory reconsolidation~     with the beta-blocker propranolol has been shown to alleviate PTSD symptoms by attenuating~     the salience of the emotional trauma memory, representing an interesting avenue for the~     treatment of adjustment disorders stemming from attachment injuries. Here, the investigators~     aim to extend the conditions under which reconsolidation therapy with propranolol can be used~     in a clinical setting. The investigators hypothesize that 6 sessions of memory reactivation~     under propranolol would significantly reduce trauma-related, depression, and anxiety symptom,~     associated with an attachment injury.~   "
31737|NCT03151668|"~     Septic shock is one of the major causes of death worldwide with in-hospital mortality rates~     varying between (11.9% to 47.2 %). Alterations in microcirculatory blood flow were associated~     with high risk of organ dysfunction and death. Experimental studies on septic rats revealed~     that dexmedetomidine treatment can effectively reduce the generation of inflammatory~     mediators and yields beneficial effects on endotoxemic animals' microcirculation.~   "
31738|NCT03151655|"~     In this treatment development project, the investigators propose to develop and assess the~     feasibility and acceptability of a narrative-based video intervention and accompanying~     workbook (entitled MATTeRS: Medication Assisted Treatments: Telling Real Stories) designed to~     be used by people in inpatient opioid detoxification. Using the Health Belief Model as a~     framework, videos will provide information about the uses and outcomes of Medication Assisted~     Treatments (MATs) compared to other or no post-detoxification treatment through the use of~     narratives from real people's lives.~   "
31739|NCT03151642|"~     The purpose of this research study will be to determine the sensitivity and specificity of~     dwMRI metrics to assess tumor response following neoadjuvant chemoradiation in esophageal~     cancer. This pilot study will generate the preliminary data needed for the design of a~     statistically-justified trial that would investigate dwMRI as an integral biomarker to~     stratify patients for escalated therapy to improve outcomes. We hope to develop dwMRI as a~     predictive clinical tool for a personalized treatment model that can identify patients who~     may be candidates for organ-preservation or treatment intensification to improve outcomes in~     esophageal cancer.~   "
31740|NCT03151629|"~     Our intent is to establish the International Registry to Improve Outcomes in Men with~     Advanced Prostate Cancer (IRONMAN) as a prospective, international cohort of minimum 5,000~     men with advanced cancer, including men with mHSPC and M0/M1 CRPC. The goal is to establish a~     population-based registry and recruit patients across academic and community practices from~     Australia, Brazil, Canada, Ireland, Sweden, Switzerland, the United Kingdom (UK), and the US.~     Target accrual number and number of participating sites are subject to change based on~     accrual, funding, and interest in participation by other international sites. This cohort~     study will facilitate a better understanding of the variation in care and treatment of~     advanced prostate cancer across countries and across academia and community based practices.~      Detailed data will be collected from patients at study enrollment and then during follow-up,~     for a minimum of three years. Patients will be followed prospectively for overall survival,~     clinically significant adverse events, comorbidities, changes in cancer treatments, and~     PROMs.~      PROMs questionnaires will be collected at enrollment, every three months for the first and~     second year then every six months.~      Physician Questionnaires will be collected from all participating sites at patient~     enrollment, time of first change in treatment and/or one year follow-up, at each subsequent~     change of treatment, and discontinuation of treatment.~      As such, this registry will help identify the treatment sequences or combinations that~     optimize overall survival and PROMs for men with mHSPC and M0/M1 CRPC. By collecting blood at~     enrollment, time of first change in treatment and/or one year follow-up (plasma, cell free~     DNA, buffy coat / RNA), this registry will further identify and validate molecular phenotypes~     of disease that predict response and resistance to specific therapeutics. Additionally, every~     effort will be made to collect blood specimen at each subsequent change in treatment. When~     feasible, existing tumor tissue may be collected for correlation with described blood based~     studies. All samples will be used for future research. This cohort study will provide the~     research community with a unique biorepository to identify biomarkers of treatment response~     and resistance.~   "
31741|NCT03151616|"~     This study investigates the association of preoperative anticholinergic medication exposure~     with healthcare resource utilization in a population-based sample of older patients enrolled~     in a universal pharmacare program~   "
31742|NCT03151603|"~     It is well known that over-treatment of straightforward infections should be avoided as far~     as possible. Evidence-based data on non antibiotic treatment options for common conditions~     are therefore needed urgently. This randomised-controlled double blind trial examines whether~     initial herbal treatment with Uva Ursi, and antibiotic treatment only if symptoms persist,~     reduces antibiotic consumption in uncomplicated urinary tract infections (UTI) without a~     negative effect on symptom course and rate of recurrent UTIs. In total, 430 patients~     presenting with typical UTI symptoms will be included by their GPs and receive randomised~     either herbal treatment with uva ursi (antibiotics only if symptoms persist), or initial~     antibiotic treatment. Patients record symptom severity and drug intake in a diary and~     complete a final questionnaire after 28 days.~   "
31743|NCT03151590|"~     The purpose of this prospective intervention study is to find biomarkers and underlying~     pathomechanisms for non-response of improvement in glucose metabolism to exercise.~      An additional goal is to identify non-responders at an early stage, where prevention~     strategies (pharmacologically or by specific training) will be successful.~   "
31744|NCT03151577|"~     To evaluate the safety and efficacy of the XEN® Gel Stent in mild to moderate glaucoma~     patients undergoing glaucoma surgery.~   "
31745|NCT03151564|"~     The goal of this clinical research study is to compare imaging software and 2 different~     radiation doses during a standard CT scan in order to see problems in the liver and still~     produce a good image quality.~      This is an investigational study. The CT scans in this study are performed using an~     FDA-approved and commercially available method. The comparison of software used in this study~     at 2 different radiation doses is considered research.~      Up to 104 participants will be enrolled in the study. All will take part at MD Anderson.~   "
31746|NCT03151551|"~     The main purpose of this study is to evaluate the effectiveness and safety of ixekizumab~     versus adalimumab in participants with psoriatic arthritis (PsA) who are biologic~     disease-modifying anti-rheumatic drugs (DMARD) naive.~   "
31747|NCT03151538|"~     The study was planned to assess effects on pes planus and femoral anteversion angle of~     exercise training mixed with play on pre-school children.~   "
31748|NCT03151525|"~     Ulcerative colitis patients treated with Infliximab (IFX) in deep remission after at least 12~     months of treatment will be randomized to continue IFX or to stop IFX and start Azathioprine~     (AZA).~      Each patient will be followed for 12 months.~   "
31749|NCT03151512|"~     This is a three-year project funded by a Cancer Research UK Multidisciplinary Award and~     brings together a team from UCL Division of Medicine, Computer Science and University College~     London Hospital. The aim is to develop Magnetic Resonance (MR) sequences and mathematical~     algorithms to reduce the distortions in MR images, especially of the prostate.~   "
31750|NCT03151499|"~     The primary objective of this trial is to investigate the relative bioavailability of BI~     409306 tablets with prior 7-day intake of rifampicin tablets (Test, T) compared to BI 409306~     tablets without prior administration of rifampicin (Reference, R) following oral~     administration in healthy male subjects.~      The secondary objective is the evaluation and comparison of several pharmacokinetic~     parameters between the treatments. The secondary objectives will be assessed by descriptive~     statistics.~   "
31751|NCT03151486|"~     The purpose of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of~     JNJ-55308942 in healthy participants after administration of single and multiple oral doses.~   "
31752|NCT03151473|"~     This is a 10-year, longitudinal, observational study of patients with NAFLD/NASH designed to~     specifically address important clinical questions that remain incompletely answered from~     registration trials. In addition to the study database, the biospecimen repository will also~     be included so that translational studies of genomics and biomarkers of response may be~     performed.~   "
31753|NCT03151460|"~     The study investigates the effect of dopaminergic stimulation over declarative memory~     functions in Parkinson's disease (PD) patients. At this aim, 20 PD patients will receive~     declarative memory tasks in two different conditions: after 12-18 hours of dopaminergic~     stimulation withdrawal (off condition) and after the first daily dose dopaminergic therapy~     (on condition). 20 healthy controls will also administered the two tasks in two conditions~     with the same inter-session delay as PD patients, but without taking drugs.~   "
31754|NCT03151447|"~     The objective of this study is to evaluate the safety and tolerance of Stereotactic Body~     Radiation Therapy Combined With Anti-PD-1 Antibody in Patients in Metastatic Triple Negative~     Breast Cancer~   "
31755|NCT03151434|"~     The purpose of this study is to compare three different pain control methods on subjects who~     are scheduled to undergo VATS (video-assisted thoracoscopic surgery) procedures. The study~     will compare their pain scores, narcotic needs, patient satisfaction scores, and narcotic~     side effects.~   "
31756|NCT03151421|"~     This is a European study which is part of a larger research project (The TackSHS project)~     funded by the European Union's Horizon 2020 Research and Innovation Programme (Grant~     Agreement No 681040) and led by the Catalan Institute of Oncology.~      This study will examine the efficacy of using personalised air quality measurements in homes~     of smokers to encourage behaviour-change towards having a smoke-free home environment.~     Building on recent quantitative and qualitative work showing that feedback of second-hand~     smoke (SHS) measurement information can help motivate smokers to change their behaviour. This~     study will develop a targeted intervention for use with socio-economically deprived smokers~     in four countries (Scotland, Spain, Greece, Italy) across the EU. Two-hundred smokers (50 in~     each country) will be recruited and offered low-cost, simple to operate particle counting~     instruments to measure and log SHS levels in their home for a period of 30 days. During this~     time near real-time, personalised feedback will be provided to, and discussed with, the~     smoker along with target-setting and exploration of suitable methods of behaviour-change.~     Feedback will be given via text message to mobile phones, emails and personal voice calls. A~     final visit will gather data on changes made while a proportion of participants (10-20%) in~     each country will take part in a further qualitative interview by phone to gather data on~     their experience of the intervention.~      Study outcomes will include quantitative measures such as changes in average and maximum fine~     particulate matter (PM2.5) concentrations and self-declared household smoking rules, while~     qualitative data will be gathered using questionnaire and interview to explore what elements~     of the intervention were useful/unhelpful, particularly well/poorly understood, and what were~     the barriers for those who did not make changes. This WP will provide a comprehensive~     database of baseline measurements of SHS concentrations in home settings from across the EU~     with the potential to generate over 8 million minutes of measurements of household air~     quality. Analysis of the differences by country and possible determinants of exposure will be~     carried out.~   "
31757|NCT03151408|"~     This is a Phase III, multicenter, double-blind, randomized study of pracinostat vs. placebo~     with azacitidine (AZA) as background therapy in patients ≥ 18 years of age with newly~     diagnosed acute myeloid leukemia (AML), excluding acute promyelocytic leukemia and~     cytogenetic low-risk AML, who are unfit to receive intensive remission induction chemotherapy~     due to age ≥ 75 years or comorbidities. Patients will be randomized in a 1:1 ratio to one of~     two groups: Group A (experimental group) to receive pracinostat plus AZA and Group B (control~     group) to receive placebo plus AZA. Randomization will be stratified by cytogenetic risk~     category (intermediate vs. unfavorable-risk, according to SWOG Cytogenetic Risk Category~     Definitions) and ECOG performance status (0-1 vs. 2). Treatments will be administered based~     on 28-day cycles, with pracinostat/placebo administered orally once every other day, 3 times~     a week for 3 weeks, followed by one week of no treatment and AZA administered for 7 days of~     each cycle. Study treatment should continue until there is documented disease progression,~     relapse from complete remission (CR), or non-manageable toxicity. A minimum of 6 cycles may~     be required to achieve a complete remission. Once permanently discontinued from study~     treatment, patients will enter the Long-term Follow-up phase of the study and will be~     followed for assessment of disease progression, if applicable, and survival every 3 months~     (±1 month) until death. The end of this study is defined when 390 events (deaths) have~     occurred and the study is unblinded for final overall survival analysis. Patients who are~     receiving study treatment at the end of the study may have the opportunity to continue to~     receive the study drugs to which they were randomized to (Post- Study Observation Period),~     until the Sponsor informs the Investigators of the appropriate course of action based on the~     study results. The Post-Study Observation Period is defined as the period starting from the~     end of the study for a maximum of 12 months.~   "
31779|NCT03151122|"~     The objective of the study is to establish a continuous nurse-led integrated support program~     and to exam its impact on preterm infant neurodevelopment.~      Research hypotheses include:1. The continuous nurse-led integrated support will have~     significant impact on preterm infant neurodevelopment; 2.The support program will also have~     positive effect on parent psychological well-being.~   "
31758|NCT03151395|"~     Since the infectious aetiology of AECOPD has been suggested to vary according to geographical~     region, the primary purpose of this study (which will be conducted in several countries in~     Asia Pacific) is to evaluate the occurrence of bacterial and viral pathogens in the sputum of~     stable COPD patients and at the time of AECOPD. Given the increasing and projected burden of~     COPD in the Asia Pacific region, this study will also evaluate the frequency, severity and~     duration of AECOPD, as well as the impact of AECOPD on health-related quality of life~     (HRQOL), healthcare utilisation and lung function.~   "
31759|NCT03151382|"~     Objective: Evaluation the improvement of the cognitive function of tandospirone add-on~     treatment on patients with AD comorbid anxiety.~      Number of Patients: 30~      Methodology: Randomized, open-label, parallel-group~      Assigned Interventions: Experimental: Tandospirone, 30-60 mg/d + Donepezil, 10 mg/d; Control~     group: Donepezil, 10 mg/d.~      Effect Evaluation: Primary Outcome: Change from baseline in ADAS-cog total score at week 12;~     NPI scale total score at week 12;~   "
31760|NCT03151369|"~     The relationship between visual pain score and perfusion index in postoperative patients.~   "
31761|NCT03151356|"~     Prostate biopsies are the gold standard for prostate cancer (PCa) diagnosis. They are~     performed according to the results of the measurement of prostate-specific antigen (PSA) in~     the serum of patients with PCa suspicion. More than half of the prostate biopsies reveal~     eventually negative because of the poor specificity of prostate-specific antigen assay. The~     Prostate Health Index (PHI) is a new diagnostic tool that has been described as a good~     predictor of prostate biopsy outcome. No large study has been performed so far in France.~     This study aim to evaluate Prostate Health Index diagnostic performances in a large~     multicentric French cohort of patients undergoing prostate biopsies because of clinical~     and/or biological suspicion of prostate cancer.~      Prostate Health Index will be measured in patients directed to prostate biopsies according to~     usual practices. Inclusion of 400 patients within 6 months in 12 French centers is expected.~     The ability of Prostate Health Index to predict prostate cancer at biopsy will be evaluated~     in terms of intrinsic and extrinsic diagnostic performances including sensitivity,~     specificity, predictive values, diagnostic accuracy, area under receiver operating curves and~     decision curve analyses.~   "
31762|NCT03151343|"~     Patients with type 2 diabetes (T2 DM) have a markedly increased risk of heart disease and it~     is estimated that, in the danish population, up 80% percent of patients with type 2 diabetes~     die from heart disease.~      The sodium glucose cotransport-2 (SGLT-2) inhibitors were developed as an anti-diabetic~     therapy reducing blood glucose and weight by decreasing glucose reabsorption in the kidneys,~     leading to glucose excretion via the urine. However, in 2015 the EMPA-REG study showed that~     treatment with the SGLT-2 inhibitor empagliflozin significantly reduced the cardiovascular~     mortality and risk of admission under the diagnosis of heart failure in a population of~     patients with type 2 diabetes in addition to other risk factors for heart disease. The~     mechanism behind this surprising result is unknown and warrants further study.~      The primary hypothesis of the present study is that treatment with empagliflozin improves the~     function and blood supply of the heart muscle cells in patients with type 2 diabetes and high~     risk of heart disease. The investigators will test this hypothesis by enrolling 92~     participants with type 2 diabetes and other risk factors for heart disease, and treating them~     with either empagliflozin or a placebo. During the study period the investigators will~     monitor the effects of the treatment with various techniques such as heart scans using CT and~     ultrasound, measurements of the fluid pressures in the heart chambers, body composition~     measurements and a variety of relevant blood test.~   "
31763|NCT03151330|"~     Background: Preterm birth (PTB) remains the leading cause of neonatal mortality and long term~     disability throughout the world. Recently treatments early in pregnancy such as progesterone,~     cervical support and maternal support have been demonstrated to delay delivery amongst at~     risk women. Nonetheless, the majority of women who are at risk are not identified using~     current screening modalities.~      Hypothesis: Women who are screened using the PreTRM® test around 20 weeks gestation will have~     a -statistically significant reduction in preterm birth compared to an unscreened historical~     control group of preterm birth.~      Study Design Type: Prospective cohort study of screened women compared to a historical~     control. The study will employ an adaptive design allowing periodic evaluation of the data to~     determine the optimal time to stop the study.~   "
31764|NCT03151317|"~     The primary objective of this study is to study the effect of therapeutic education on~     patient adherence for at-home continuous positive airway pressure (CPAP) or at-home~     non-invasive ventilation. This first study will use data already present in the Association~     for Home Assistance and Rehabilitation (APARD) database to compare patients who received~     therapeutic education with a control group who did not.~   "
31765|NCT03151304|"~     This is a Phase 2, two-stage study of the safety and efficacy of pracinostat in combination~     with azacitidine in patients with IPSS-R high and very high risk MDS who are previously~     untreated with HMAs. Enrollment in this study will be limited to high/very high risk MDS~     because this group represents the highest unmet need, with median survival of less than 18~     months.~      Stage 1 will be conducted as an open-label single arm in up to 40 subjects to assess if this~     regimen with a lower pracinostat dose results in a discontinuation rate that meets a~     predefined threshold and in efficacy that justifies expansion of enrollment into Stage 2.~      A discontinuation rate of approximately ≤10% in Stage 1, a rate comparable to that observed~     with azacitidine alone in study MEI-003, is considered desirable and supports expansion into~     Stage 2.~      Stage 2 will be conducted as a randomized, double-blind, placebo-controlled, two-arm design~     to confirm that the discontinuation rate observed in an open-label design can be reproduced~     in a placebo controlled design, and to provide unbiased information on efficacy and safety.~     Subjects will be randomized in a 1:1 ratio to one of the 2 treatment arms (Arm A, pracinostat~     + azacitidine and Arm B, placebo + azacitidine). Study drugs should be continued until~     disease progression or intolerable toxicity. It is important to note that the median time to~     achieving a response with azacitidine alone is 4 to 5 months. Furthermore, the median time to~     achieving a CR in study MEI-003 was 4 cycles. Therefore, early (<6 months) discontinuation of~     trial therapy for 'no response' should be avoided. The Medical Monitor should be contacted~     prior to discontinuing a subject from the study to discuss the rationale for discontinuation.~   "
31780|NCT03151109|"~     This study will look at patient radiographic and functional outcomes who have or will undergo~     a reverse, extended peg, shoulder arthroplasty (replacement) that requires the use of glenoid~     bone grafting.~   "
31766|NCT03151291|"~     Patients suffering from cancer often experience a loss of muscle mass and strength during~     disease and its therapy. Muscle wasting is the main characteristic of the so-called cancer~     cachexia syndrome and responsible for many therapy-related complications and a poorer~     prognosis of the patient. Stabilizing muscle mass should therefore be a great goal in cancer~     care. Physical exercise and nutrition are promising measures to combat cancer-related muscle~     atrophy but conventional exercise programs may not always be suitable for physical-weakened~     patients and increased catabolic processes are difficult to overcome by normal Nutrition -~     especially in advanced cancer. Therefore, the present study aims to test a combined approach~     of specific nutritional supplementation and exercise using the novel strength training method~     of Whole-Body electromyostimulation (WB-EMS). The study investigates the effect of a 12-week~     WB-EMS training combined with a dietary supplementation of β-hydroxy-β-methylbutyrate (HMB),~     L-carnitine (LC) or the omega-3-fatty acid eicosapentaenoic acid (EPA) on skeletal muscle~     mass, body composition, physical function, nutritional and inflammatory status, fatigue and~     quality of life in cancer patients undergoing oncological treatment. The results of this~     study may help to clarify the effectiveness of those combined interventions to counteract~     muscle wasting and other symptoms of cancer cachexia.~   "
31767|NCT03151278|"~     This study is intended to compare the feasibility, safety and efficacy of a zero-fluoroscopic~     approach with conventional fluoroscopic approach as performing catheter ablation of right~     atrial arrhythmias.~   "
31768|NCT03151265|"~     The objective of this Investigator Initiated study is to evaluate the effectiveness of~     ThermaCare HeatWraps in improving flexibility and low back muscle relaxation, and in~     participants experiencing pain, reducing pain during movement. This study is an intervention~     trial on two discrete subject samples; (1) people with recent back pain, and (2) people who~     regularly play sport. ViMove wearable sensors provide precise objective measurements of low~     back muscle activity and movement in real time and can capture a patient's reporting of pain~     during movement. Outcomes will be assessed through standard ViMove protocols in conjunction~     with multiple validated measures of pain, perception of change, and function.~   "
31769|NCT03151252|"~     Currently, diagnostic possibilities for the detection of food allergy in the gastrointestinal~     tract are scarce. The endoscopic segmental Lavage is the method of choice, but it´s~     controversial.~      Additional to the endoscopic segmental lavage fluid a cytobrush is used for collecting the~     mucosa cells and biopsies are taken. Comparative to the Lavage specific IgE antibodies, Tumor~     necrosis factor- alpha, Eosinophilic cation protein and mastcell tryptase were measured.~   "
31770|NCT03151239|"~     The purpose of the study is to understand the effect of the dietary supplement Nicotinamide~     mononucleotide on metabolic health in women.~   "
31771|NCT03151226|"~     Non emergent scheduled cesarean sections will be consented to participate in this study of~     patients who have screened negative for obstructive sleep apnea and who are also BMI>/= 35 to~     have capnography monitoring postoperatively. The capnography and pulse oximetry will be~     initiated in the post anesthesia care unit and be worn for 12-24 hours after delivery. Data~     will be retrieved after that time period in a deidentified fashion. Medication usage will be~     reviewed as well as the standard of care information from the duramorph monitoring will be~     retrieved.~   "
31772|NCT03151213|"~     The study aimed to investigate the preemptive analgesia efficacy of of preemptive pregabalin~     for the postoperative pain management after radiofrequency ablation (RFA) of liver cancer.~   "
31773|NCT03151200|"~     The purpose of this study is to assess the effectiveness of combining binocular treatment~     with repetitive transcranial magnetic stimulation (rTMS) in improving the vision of adults~     with amblyopia. This study also seeks to assess the effect of this combined treatment on~     cortical neural function and functional connectivity.~   "
31774|NCT03151187|"~     The investigators have initiated an education program for residents on the diagnosis and~     management of disruptive behavior disorders in children. These will be presented as two~     2-hour modules to be delivered at an academic half-day for pediatric trainees across Canada.~     We plan to evaluate the effectiveness of the curriculum by administering a pre and post test.~     Pediatric residents in Canada all participate in a practical assessment of their skills (an~     Observed Structured Clinical Examination or OSCE). The investigators plan to develop on OSCE~     station which assesses the curriculum and randomize programs to do the curriculum either~     before or after the OSCE. This will help us determine how effective the curriculum is at~     teaching about disruptive behaviours.~   "
31775|NCT03151174|"~     The goal of this study is to determine whether Vitamin D supplementation improves strength~     and bone density, and reduces the risk of injury in collegiate athletes.~   "
31776|NCT03151161|"~     EGFR-tyrosine kinase inhibitor(TKI)- ie, erlotinib, gefitinib, icotinib,has been recommended~     as the first option for EGFR-mutated IIIb/IV NSCLC by serial trials as it prolonged patients'~     progression-free survival. The OPTIMAl trial indicated that those who received TKI and~     chemotherapy during the whole treatment window survived longest. Unfortunately, previous~     studies(INTACT, TRIBUTE et al) that concurrently combined TKI and cytotoxic regimens failed~     to improve survival in unselected patients. To avoid the potential synergistic antagonism,~     the FAST-ACT II trial committed a sequential strategy and find a superiority in the~     combination arm upon chemotherapy even in EGFR-mutated group. However, pharmaceutically, the~     continuous administration of an EGFR-TKI before subsequent chemotherapy in FAST-ACT II could~     obviate the effects of cytotoxic agents due to the erlotinib-induced G1 arrest.~      On the basis of these and other studies, the investigators hypothesized that a better~     sequential combination strategy of EGFR-TKI and chemotherapy (adding a EGFR-TKI wash-out~     window before chemotherapy) would be more efficacious than chemotherapy alone. In this study,~     the investigators investigate the efficacy(PFS:progression free survival), safety, and~     adverse-event profile of chemotherapy plus intermittent and maintenance of icotinib compared~     with icotinib single drug, when these drugs were used as first-line treatment in who had~     non-squamous lung carcinoma with EGFR gene mutation in China.~   "
31777|NCT03151148|"~     The purpose of this study is to examine the safety and effectiveness of a new therapy,~     commensal lotion containing infection fighting bacteria, on decreasing or eliminating the~     infection causing bacteria found on the skin of Atopic Dermatitis (AD) patients.~   "
31778|NCT03151135|"~     Pilot study to assess energy turnover at end of inpatient treatment in 10 patients with~     Anorexia nervosa.~   "
31781|NCT03151096|"~     Hypertension, which results from a combination of multiple lifestyle and genetic factors, is~     a global public health problem affecting 1 billion people worldwide. The identification of~     cheap treatment interventions without adverse side effects would be hugely advantageous~     particularly in low-income settings with high prevalence of hypertension such as sub-Saharan~     Africa where up to 46% of adults are affected.~      Emerging evidence links a functional polymorphism in the MTHFR gene (rs1801133 C677T),~     encoding the folate-metabolising enzyme methylenetetrahydrofolate reductase to high blood~     pressure in adults. Variation at rs1801133 is relatively common and has 3 genotypes;~     homozygous normal CC, heterozygous CT and homozygous variant TT genotypes. Of these~     genotypes, the homozygous variant TT is more strongly associated with a higher BP. The~     precise mechanism by which MTHFR is associated with BP remains unclear. It has been recently~     shown in 3 separate randomized controlled trials that BP is highly responsive to riboflavin~     and that this response is differential by MTHFR rs1801133 genotype. In all these clinical~     trials, significant reduction in both systolic and diastolic blood pressure was observed in~     the homozygous variant TT genotype and an intermediate effect seen in those with the~     heterozygous CT genotype. The aim of this study is to evaluate the effect of riboflavin~     supplementation on blood pressure in a riboflavin-deplete population as well as comparing~     plasma riboflavin status before and after supplementation. This will be achieved by~     conducting a randomized single-blind placebo controlled trial over a period of 16 weeks.~      The Investigators will use the Keneba biobank to invite about 100 adults with the CT genotype~     and a similar number of age-, sex and village-matched CC homozygotes. Participants within~     each of the groups will be randomized to receive either riboflavin (5mg/d) or a matching~     placebo which would be supplied on a weekly basis. Blood sample, blood pressure measurement,~     socio-demographic data and their anthropometric measurements (height, weight, waist and hip~     circumference and body composition by BIA) will be taken during the initial visit. An~     additional blood sample will be taken at the end of the study whilst additional BP~     measurements will be taken respectively at 8 weeks and at the end of the intervention. The~     possibility that riboflavin deficiency represents a new, easily-correctible causal factor in~     hypertension in sub-Saharan Africa would require further large-scale interventions if this~     pilot study yields encouraging results.~   "
31782|NCT03151083|"~     Internet-based self-help programs are personalized, self-guided interventions delivered over~     a computer, mobile device, or other Internet platform and focused on improving knowledge,~     awareness, or behavior change for a mental or physical health problem. Through previous and~     on-going projects at VACT, the investigators are developing a general strategy for~     implementing Internet-based Self-help programs in VA primary care, specifically among Patient~     Aligned Care Teams (PACT) and Primary Care Mental Health Integration (PCMHI) providers. An~     implementation strategy is defined as a systematic intervention to integrate evidence-based~     health innovations into usual care. The strategy the investigators propose to test consists~     of four core components: (1) a clinical intermediary for patient support, (2) provider/staff~     facilitation and education, (3) patient education, and (4) stepped-care for those requiring~     additional treatment. In the proposed study, the investigators will compare this strategy to~     a low intensity (control) strategy with respect to the implementation related outcomes of~     patent engagement, provider adoption through referral to the program, and patient completion,~     over a six-month active implementation period. The investigators will target the very common~     clinical problem of insomnia and use the SHUTiTM program, a 6-week self-guided program~     utilizing standard cognitive-behavioral therapy (CBT) techniques for the treatment of chronic~     insomnia. The program has been shown to improve insomnia severity and other sleep related~     outcomes in a number of controlled trials. The clinical effectiveness of SHUTiTM will be~     evaluated using clinical insomnia outcomes obtained on all patients enrolled over the 6-month~     active implementation periods. The purpose this study is to evaluate the preliminary (1)~     effectiveness of an implementation strategy for Internet-based Self-help Interventions and~     (2) clinical outcomes of a specific Internet-based self-help program for insomnia, SHUTiTM,~     in VA Connecticut outpatient primary care. The primary hypothesis is that the experimental~     implementation strategy the investigators are developing, relative to a control strategy,~     will result in higher rates of program engagement by patients, greater provider adoption~     through referral to the program, greater program completion, and improved patient insomnia~     outcomes.~   "
31783|NCT03151070|"~     ¡Que Vivan las Madres!: Venga a tener su parto al CAP (QVLM) is a guatemalan~     quasi-experimental study that has been performed from January 2014 to January 2017 by the~     Epidemiological Research Center in Sexual and Reproductive Health (CIESAR) in Guatemala in~     coordination with PRONTO International and University of San Francisco, California. This~     project has been financed by Grands Challenges Canada' Save Lives at Birth, A Grand~     Challenge for Development partnership that includes USAID, Norwegian ministry of foreign~     affairs, Bill&Melinda Gates foundation, UKaid. This project has applied a stepped wedge~     design (SWD) over 6 zones or clusters. Each one of the zones contains from 4 to 6~     communities, each one with the presence of one second level health facility (known in Spanish~     as CAP, Centro de Atención Permanente). These health centers are the next level in attention~     after home, traditional and empirical attention. Communities around the selected health~     centers are mostly rural and have the worst maternal health indicators in the country. These~     health centers are expected to have enough equipment and personnel to attend the deliveries~     that occur in their communities. This study was performed in Huehuetenango and Alta Verapaz~     districts in north Guatemala. Each one with 3 zones for a total of 6 zones. The study follows~     a Stepped Wedge Design, in which all 6 zones are eventually intervened, but at different~     regular periods of time (each period is 4 months long). This project applies a package of 3~     simultaneous interventions in each zone with the purpose of increasing institutional~     deliveries and improving deliveries attention in public health centers. This intervention~     plan has been implemented in a pilot study reported in (Kestler et. al, 2013).~   "
31784|NCT03151057|"~     This is a randomized double blinded Phase 1 placebo study to evaluate the safety of~     idelalisib as post-transplantation maintenance in patients with B cell hematologic~     malignancies undergoing a allogeneic hematopoietic stem cell transplant (HSCT). Safety will~     be evaluated through the assessment of cytopenias, effect on donor chimerism, effect on the~     incidence and severity of acute graft versus host disease, and gastro-intestinal tolerance.~   "
31785|NCT03151044|"~     This clinical trial is designed to compare the efficacy and safety of R±CEOP90 containing~     high-dose epirubicin and R±CEOP75 containing standard epirubicin in newly diagnosed young~     patients with medium/high-risk diffuse large B-cell lymphoma. Half of the participants~     receive R±CEOP regimen containing 90mg/m2 epirubicin, while the other half of participants~     receive R±CEOP regimen containing 75mg/m2 epirubicin. Via exploring whether high-dose~     epirubicin shall achieve better efficacy and less toxicity, we hope to optimize current~     treatment choice for young patients with medium/high-risk diffuse large B-cell lymphoma.~   "
31786|NCT03151031|"~     The purpose of this study will determine the effect of cryotherapy applied to the knee joint~     on static and dynamic standing balance. It is hypothesized that there will be no change in~     dynamic postural stability after cryotherapy application.Twenty four individuals (age 18 to~     30) participated in the study. They will be randomly divided into two groups, experimental~     and control group. Each participant, in the experimental group will be asked to perform star~     excursion balance test (SEBT) under two conditions, before and after the application of~     cryotherapy. The participants will receive ice pack wrapping of the knee for 10 minutes. The~     control group performed SEBT at room temperature in an interval of 10 minutes. The two group~     will be analysed and compared~   "
31787|NCT03151018|"~     The objectives of this study are~        1. To establish a prospective registry of the whole patients who received percutaneous~          coronary intervention with Resolute Onyx™ stent.~        2. To evaluate the long-term efficacy and safety of coronary stenting with the Resolute~          Onyx™ stent.~        3. To compare the long-term efficacy and safety of coronary stenting between the Resolute~          Onyx™ stent and other contemporary drug-eluting stents which had established their own~          registry.~   "
31788|NCT03151005|"~     Polycystic ovary syndrome (PCOS) is a health problem that affects one in 10 women of~     childbearing age, which is usually characterized by hormonal imbalance and metabolism~     problems such as hyperandrogenism and obesity. Diane 35 pills are classified as oral~     contraceptives, which effectively reduces circulating androgens and are treatment for~     hyperandrogenism caused androgenic skin symptoms and irregular menstrual cycles. GLP-1~     Receptor Agonist(e.g. exenatide, liraglutide) have the effects of lowering blood sugar and~     weight control by inhibiting of gastric emptying and reducing food intake. This study aims to~     evaluate the effect of metformin-GLP-1 Receptor agonist combination versus metformin-Diane-35~     combination treatment on lipid metabolism and cardiovascular risks in overweight polycystic~     ovarian syndrome (PCOS) patients.~   "
31789|NCT03150992|"~     A feasibility study to provide 'proof of concept' of Elemental Diet (ED) as an acceptable/~     useful feeding option for patient with inoperable malignant bowel obstruction and to examine~     the impact of ED on quality of life~   "
31790|NCT03150979|"~     Previous studies failed to determine the real effects of the provision of a walking cane~     after a stroke, mainly due to biases related to their methodological designs. In addition,~     there is no information on the carry-over effects of a cane to social participation. This~     study will test the hypothesis that the provision of a cane is effective in improving walking~     speed, step length, cadence, walking capacity, walking confidence, and participation of~     individuals with chronic stroke. For this prospective, single-blinded, randomized clinical~     trial, people after stroke will be randomly allocated into either experimental or control~     groups. The experimental group will receive a single-point cane, with ergonomic handgrip,~     which will be individually adjusted to the participant's height. A physiotherapist will~     provide instructions on how to walk with the cane and the participants will practice for~     about 15 minutes or until they feel comfortable with the device. Then, they will take the~     cane home and will be instructed to use it all the time during locomotion. Weekly, they will~     receive a phone call, to ensure that they are using the cane and to clarify any doubts. A~     home visit may be conducted, if necessary. The control group will be instructed to perform~     stretching of the lower limb muscles daily and keep their daily activities, without the use~     of a cane. To ensure the level of attention similar to that of the participants in the~     experimental group, the individuals in the control group will also receive weekly phone~     calls. At baseline (Week 0), post intervention (Week 4), and one month after the cessation~     (Week 8) of the interventions, researchers blinded to group allocations will collect all~     outcome measures.~   "
31791|NCT03150966|"~     Multiple sclerosis is the most common autoimmune disease of the central nervous system, most~     ranging in age from 40-20 years of age is associated with neurons inflammation and~     demyelination. Increasing aggressive activities of Th17 and Th1 cells that their function is~     to secrete proinflammatory cytokines and decreasing the number and activity of regulatory T~     cells, which normally leads to controlling inflammation, are seen in these patients.Curcumin~     is a polyphenol. Curcumin binding with a range of protein and the have ability to inhibit the~     activity of various kinases. Curcumin has a combination of activities such as antioxidant,~     anti-proliferation, anti-invasive, and can used in the treatment of Alzheimer's, Parkinson's,~     Multiple sclerosis, Cardiovascular disease, Bacterial diseases and Arthritis.~   "
31792|NCT03150953|"~     Patients under deep sedation and general anesthesia lose heat to their surrounding~     environment. Hypothermia after anesthesia is associated with worse patient outcomes,~     including increased number of infections and cardiovascular complications. Cardiac MRI scans~     performed for patients who require general anesthesia can cause a loss of body heat.~      Several mechanisms exist for reducing hypothermia under anesthesia including forced air~     warmers, fluid warmers, radiant warmers, and chemical warmers. Unfortunately, there are no~     MRI-compatible systems which allow patient warming and prevention of hypothermia in~     anesthetized patient in the MRI-scanner.~      This study is testing a non-invasive device that warms patients under clinically indicated~     general anesthesia in the MRI scanner. This device will keep in the heat made by the MRI~     scanner.~   "
31793|NCT03150940|"~     This is a study supported by Duke Sports Cardiology and Duke Sports Medicine with the intent~     to enhance the cardiovascular screening of collegiate athletes from a regional to nationally~     recognized program to understand and eventually reduce cardiovascular events in athletes. The~     data from this ongoing registry will be used to better understand, refine, and improve the~     current cardiovascular Duke Athlete Screening process and use this experience as a role model~     to expand across the ACC.~   "
31794|NCT03150927|"~     This study is to determine if a novel bio-fermented Microbiotic Composite™ can improve the~     digestive health and subsequent growth and quality of life parameters in a selected group of~     children in a district in India.~   "
31795|NCT03150914|"~     This is a study to determine if early, long-term low dose sirolimus is effective for~     preventing progression to more advanced stages.~   "
31796|NCT03150901|"~     Diabetic patients with a history of diabetic foot are considered to be a high-risk population~     for increased cardiovascular and all-cause mortality (1,2,3,). Diabetic foot (DF) is~     responsible for more hospitalizations than any other complication of diabetes and are the~     leading cause of non-traumatic lower extremity amputations, resulting in nearly 100 000~     amputations annually in the US alone (4,5,6). Surgical debridement, as an important component~     of standard of care of diabetic foot, is intended to remove healing-impaired tissue,~     decreases bacterial burden, thus to stimulate overall wound closure, while removing as little~     of healing-competent skin as possible. Furthermore, debrided tissue is often used as a~     valuable tissue source for research purposes (7,8,9,10). Debrided tissue presents valuable~     diagnostic and research source to verify pathology, assess prognosis and gain insights into~     DF molecular pathology, all of which ultimately leads to improved outcomes.~      We aimed to validate tissue obtained from surgical debridement of DF for the~     cellular/molecular tissue analyses and biomarkers, to evaluate the pathophysiology of DF and~     understanding mechanisms that inhibit healing.~      The age range will be 50-70 years, in order to minimize the effects of irreversible vascular~     wall changes induced progressively by the aging process. All patients will undergo screening~     procedures that will include full anamnesis, physical examination, basic laboratory blood~     tests (full chemistry, CBC); urine examination and EKG will be performed at start and at the~     end of the study. Patients with a significant myocardial, and renal, cerebrovascular or~     hepatic disease will be excluded from the study.~      In a prospective study, we will collect wound edge tissue specimens from 75 patients with DF~     during surgical debridement. From each patient, 1-4 specimens will be obtained per~     debridement. To evaluate debrided tissue, each specimen will be processed for paraffin~     embedding and stained with haematoxylin and eosin. Histopathology analysis of multiple~     specimens acquired from the same wound will be analysed.~   "
32078|NCT03147144|"~     The aim of this study is to prospectively examine the relationship of the uterine junctional~     zone thickness, evaluated by ultrasonography and In Vitro Fertilization (IVF) treatment~     outcome. The study hypothesis is that the uterine junctional zones of women who did not~     achieve pregnancy will be thicker than those of the women who do achieve pregnancy~   "
31797|NCT03150888|"~     The purpose of this study is to construct hypertension specialized cohort using uniform~     standards and specifications. This study timely collected multi-dimensional clinical~     information through electronic medical records, mobile health, data integration, informatics~     and computer modern techniques, linking self-reported data and big data platforms from~     different sources to timely obtain the incidence and mortality data, and integrating~     hypertension cohort samples and the associated clinical records systematically, in order to~     build a 30-thousand hypertension specialized cohort with fine phenotypic data and blood/urine~     samples, thus far to provide support for the development of precise medicine research and~     related industries.~   "
31798|NCT03150875|"~     Similar clinical trial results demonstrated that anti-PD-1 antibodies prolonged OS to~     approximately 9 months compared with 6 months in docetaxel group. Anti-PD-1 therapy in~     Chinese squamous NSCLC patients will be investigated in this clinical trial.~      Additionally the correlation between PD-L1 expression and the response to IBI308 treatment in~     Chinese squamous cell NSCLC as well as the role of irRECIST in immune checkpoint inhibitor~     treatment evaluation will also be assessed~   "
31799|NCT03150862|"~     This study is to evaluate the safety, efficacy and clinical activity of BGB-290 in~     combination with radiation therapy (RT) and/or temozolomide (TMZ) in subjects with newly~     diagnosed or recurrent/refractory glioblastoma.~   "
31800|NCT03150849|"~     Chronic lymphocytic leukemia is the most common type of chronic leukemia, accounting for~     approximately 40% of all leukemias and mainly affecting older individuals. As it has a highly~     variable clinical course, identification of molecular and biological prognostic markers has~     provided new insights into the risk stratification of patients with chronic lymphocytic~     leukemia.~   "
31801|NCT03150836|"~     This is a multi-site, randomized, prospective, open-label phase II study. Patients in this~     study will have localized (cT3-cT4), or metastatic bladder cancer with a symptomatic, intact~     primary bladder tumor. In this study, patients will undergo stereotactic body radiation~     therapy (SBRT) to the bladder tumor and will receive durvalumab with or without tremelimumab.~   "
31802|NCT03150823|"~     Electrical stimulation currently has a wide range of clinical applications, being used for~     activities such as strengthening, pain control, edema management, or inflammation control~     after injury or surgery. One of the classic forms of electrotherapy is the Direct current~     (galvanic current), which stands out for its unique effects (polar and interpolar effects)~     and that are not achieved with other modalities of electrotherapy. Within these effects those~     activators or suppressors of nervous system activity are described. One of the applications~     of direct current is to produce sedation or excitation on the nervous system through~     longitudinal applications (longitudinal galvanization). This application technique is known~     as the upstream or downstream effect of the direct current or Leduc Effect, in which it is~     postulated that an ascending type longitudinal galvanization has excitation effects of the~     central and / or peripheral nervous system. The study will evaluate the influence of the~     upward and downward direct current effect when performing a manual dynamometer test while~     monitoring by miofeedback in college students.~   "
31803|NCT03150810|"~     This study is to evaluate the safety, efficacy and clinical activity of BGB-290 and~     temozolomide (TMZ) in subjects with locally advanced or metastatic solid tumors.~   "
31804|NCT03150797|"~     This will be a randomized, multi-site double-blind placebo-controlled trial of melatonin (2~     different dosing arms) vs. placebo for migraine prevention in adolescents. We intend to~     enroll approximately 210 participants over 15 months at two sites: UCLA and UCSF. The~     duration of participation for each participant will be 4 months.~   "
31805|NCT03150784|"~     The importance of play and physical activity include many benefits on positively improving~     health and well-being, enhancing children's and young people's thinking and performance in~     school, improving their sleep and enabling confidence and skill building. However, some~     children find it hard to learn and perform motor skills, and are at risk of decreased~     participation in sports and physical activity and subsequently decreased physical fitness and~     overall health and well-being.~      Previous studies from the research group have explored the impact and recovery following~     acute exercise at different intensities in children and adolescents with and without movement~     difficulties. Following this, a pathway promoting physical activity and engagement has been~     successfully established within schools for those with and without movement difficulties.~     Taking the previous studies further, we want to specifically focus on the children's~     performance and learning of a sporting skill, such as stepping, and the associated brain~     activity changes, using available high resolution imaging techniques. This will help us~     understand how these children perform and learn motor and sporting skills. Evidence obtained~     from imaging alongside measures of movement has helped the development of optimal therapeutic~     approaches for other conditions such as stroke and Parkinson's and will help us to develop~     approaches to help children best learn motor skills and hence gain confidence in performing~     sporting activities.~   "
31806|NCT03150771|"~     This trial will determine the Pharmacokinetics, safety and tolerability of single-dose~     Aripiprazole administered intramuscularly in adults with schizophrenia~   "
31807|NCT03150758|"~     Erectile dysfunction persists in approximately 80% of men 1 year after prostatectomy. Various~     erectile rehabilitation strategies have not provided benefit. Electrical stimulation has been~     demonstrated to benefit neuroregeneration and the functional recovery of neuromuscular~     systems. Therefore, electrical stimulation of the cavernosal nerves during radical~     prostatectomy is being investigated for its potential development into a treatment aimed at~     improving recovery of erectile function after prostatectomy. This pilot study is intended to~     determine the threshold of electrical stimulation that results in penile erection, as defined~     by persistent intracavernosal pressure increase, such that future studies of sub-threshold~     stimulation may be pursued.~   "
31830|NCT03150446|"~     The aim of this study was to evaluate the role of flexible cystoscopy in preventing~     malpositioning of the ureteral stent after laparoscopic ureterolithotomy in male patients.~      From April 2009 to June 2015, 97 male patients with stones >1.8 cm in the upper ureter~     underwent intracorporeal double-J stenting of the ureter after laparoscopic ureterolithotomy~     performed by four different surgeons. In the last 50 patients who underwent laparoscopic~     ureterolithotomy flexible cystoscopy was performed through the urethral route to confirm the~     position of the double-J stent, while in the first 47 correct positioning of the stent was~     confirmed through postoperative KUB.~   "
31808|NCT03150745|"~     Endocervix (cervical canal) is the cavity of the cervix and connects the external os with the~     internal os. It is fusiform in shape and has posterior and anterior oblique longitudinal~     ridges, the plicae palmatae. These are not exactly apposed but inter-lock like a zipper so~     that the canal is kept closed.~      The original squamous epithelium is clearly identified as a smooth, usually featureless~     covering of the cervix; its uniform pink color contrasts with the redness of the original~     columnar epithelium. It joins the latter at the original squamocolumnar junction.~      Many clinicians encounter cervical lesions that may or may not be associated with cytologic~     abnormalities. Such abnormalities as ectropion, Nabothian cysts, and small cervical polyps~     are quite benign and need not generate concern for patient or clinician, whereas others,~     including those associated with a history of exposure to diethylstilbestrol, cervical~     inflammation, abnormal cervical cytology, and postcoital bleeding, should prompt additional~     evaluation. Further, in some patients, the cervix may be difficult to visualize. Several~     useful clinical suggestions for the optimal examination of the cervix are presented.~   "
31809|NCT03150732|"~     Comparison of systemic nalbuphine versus intravenous regional anesthesia in patients~     undergoing hand surgery.~   "
31810|NCT03150719|"~     Study VX16-661-114 (Study 114) is a Phase 3b, randomized, double-blind, placebo-controlled,~     parallel group, multicenter study in subjects aged 12 years and older with CF who are~     homozygous for the F508del mutation on the CFTR gene and who discontinued treatment with~     Orkambi due to respiratory symptoms considered related to treatment. This study is designed~     to evaluate the safety and efficacy of TEZ/IVA.~   "
31811|NCT03150706|"~     The POLE mutations represent high somatic mutation loads in patients with colorectal cancer,~     especially in those with MMR proficient or MSS, therefore, tumors harbouring POLE mutations~     might be susceptible to immune checkpoint blockade.~      Based on these reasons, Investigator planned a phase II study of avelumab monotherapy in~     patients with previously treated, metastatic, MMR deficient (MSI-H) or POLE mutated~     colorectal cancer.~   "
31812|NCT03150693|"~     This partially randomized phase III trial studies the side effects of inotuzumab ozogamicin~     and how well it works when given with frontline chemotherapy in treating patients with newly~     diagnosed B acute lymphoblastic leukemia. Monoclonal antibodies, such as inotuzumab~     ozogamicin, may block cancer growth in different ways by targeting certain cells. Drugs used~     in chemotherapy work in different ways to stop the growth of tumor cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. Giving~     inotuzumab ozogamicin with chemotherapy may work better in treating young adults with B acute~     lymphoblastic leukemia.~   "
31813|NCT03150680|"~     The purpose of the research project is to investigate the potential association of 207~     genetic polymorphisms with the complexity and the severity of coronary artery disease (SYNTAX~     score), along with the patients' response to clopidogrel and statin therapy. The aim of the~     study is to combine genetic, pharmacogenetic, clinical and laboratory data in order to create~     an algorithm (GEnetic Syntax Score-GESS) that will enable an individualized therapeutic~     patient approach.~   "
31814|NCT03150667|"~     To compare clinical outcomes in patients with chronic kidney disease (CKD) presenting with an~     acute coronary syndrome (ACS) treated with clopidogrel or ticagrelor (both FDA approved and~     guideline indicated drugs for treating these patients upstream managed medically or with~     coronary revascularization).~   "
31815|NCT03150654|"~     It has been hypothesized that thermal damage of laser pan-retinal photocoagulation may affect~     macular pigment as well as inner layer cells in the retina, so it was aimed to investigate~     possible effect of conventional laser pan-retinal photocoagulation on macular pigment optical~     density in diabetic retinopathy patients without macular edema and pathology in this study.~   "
31816|NCT03150641|"~     After delivery of a baby, the umbilical cord is cut to separate the baby from the placenta~     and the mother. The best time to cut the umbilical cord of full term babies is unknown.~     Traditionally, the umbilical cord is cut immediately at birth. There is however, continued~     blood flow from the placenta to the baby after delivery and so there may be a benefit to the~     baby from waiting to cut the cord until one minute after delivery. Studies show that delaying~     cutting the cord until at least one minute after delivery increases a full term baby's blood~     count in first two days of life and increases the baby's iron levels. The impact of delaying~     cutting the umbilical cord on a mother's health is not fully known. Delaying cutting the cord~     has minimal impact on the mother's health when the baby is delivered vaginally, but it is not~     known how delaying cutting the cord impacts the mother's health (and specifically the amount~     of blood a mother loses at delivery) when the baby is delivered by cesarean.~      The purpose of this research study is to find out how delaying cutting the umbilical cord~     until one minute after delivery of the baby during a cesarean impacts the amount of blood the~     mother loses during surgery. The study will also examine the benefits to the newborn from~     delayed cord clamping during cesarean.~   "
31817|NCT03150628|"~     Rationale: For patients with peritoneal metastases of gastric origin, there is no consensus~     on the optimal treatment strategy. Several Asian and Western studies demonstrated~     hyperthermic intraperitoneal chemotherapy (HIPEC) and cytoreductive surgery (CS) to result in~     a prolonged survival compared to palliative systemic treatment. Morbidity and mortality rates~     of HIPEC and CS appear to be acceptable. In the Netherlands, this treatment is not yet~     introduced, therefore patients with peritoneal metastases of gastric origin are precluded~     from surgery and will be treated with palliative chemotherapy or best support of care.~      Objective: To assess the safety and feasibility of HIPEC and CS in Western patients with~     peritoneal metastases of gastric cancer, in terms of morbidity and mortality. Secondary~     objective is to determine the effect on survival and recurrence.~      Study design: Mono centre prospective phase II single-arm feasibility study.~      Study population: Western patients diagnosed with resectable (cT1-4b, N1-3) gastric cancer~     with clinical or pathologically proven peritoneal metastases without distant metastases.~      Intervention: Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and Cytoreductive Surgery~     (CS) with Cisplatin.~      Main study parameters/endpoints: Primary outcome is the safety and feasibility of the~     intervention, measured by the percentage of overall surgical complications grade ≥3 as stated~     by the Common Terminology Criteria for Adverse Events. Secondary outcomes are intraoperative~     events, postoperative morbidity and mortality, postoperative recovery, including quality of~     life, and disease free- and overall survival.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: The additional burden for the patient mainly consists of HIPEC and~     CS.Furthermore, patients will undergo additional staging in order to exclude unresectable~     disease, and neoadjuvant chemotherapy regimen (3 drugs) instead of a palliative chemotherapy~     regimen (2 drugs). Postoperative care and outpatient visits are performed according to~     current protocols on HIPEC and CS for colon cancer and nation-wide protocols on gastric~     cancer surgery. The study is associated with a high risk classification. As there is a~     potential survival benefit, a small chance for curation and possibly a higher quality of~     life, we consider the additional burden and risks justified. This study is designed as a one~     group study, which eliminates group relatedness.~   "
31831|NCT03150433|"~     This is a study testing the effects of behavioral sleep interventions on pain and brain~     function in sickle cell disease.~   "
31818|NCT03150615|"~     Pancreaticoduodenectomy (PD) is the treatment of choice for resectable periampullary cancer.~     PD is still associated with a relatively a high incidence of delayed gastric emptying. And,~     there are no acknowledged strategies to avoid DGE. Several feeding strategies have been~     investigated to cope with this problem. However, there is still no consensus concerning the~     best nutrition support method after pancreaticoduodenectomy. The purpose of this study is to~     determine the effect of nutrition support methods on DGE after pancreaticoduodenectomy: early~     enteral nutrition or total parenteral nutrition.~      Patients undergoing pancreatoduodenectomy will be randomized to receive early enteral~     nutrition (EN group), or Saline administration (Saline group), or oral intake only (Natural~     control). The EN group will receive standard enteral diet administered through a nasojejunal~     tube. Enteral nutrition will be started on the 1st postoperative day and increased daily by~     20-40 ml up to the estimated level. The Saline group will receive saline administered through~     a nasojejunal tube beginning from the 1st postoperative day. Oral intake will not be~     restricted in all three group.~   "
31819|NCT03150602|"~     This study is to evaluate the objective response rate to pralatrexate in Asian PTCL patients~     after prior treatment failure, as determined by independent imaging reviewer(s) using~     international workshop lymphoma response criteria (IWC)~   "
31820|NCT03150589|"~     This is a randomised, double-masked, parallel group, multicentre study to evaluate the~     efficacy, safety, pharmacokinetics and immunogenicity of SB11 compared to Lucentis® in~     subjects with neovascular AMD.~   "
31821|NCT03150576|"~     This neoadjuvant trial for patients with TNBC and/or gBRCA breast cancer, aims to investigate~     the safety and efficacy (improvement in pathological Complete Response at surgery) of~     concurrent platinum-based chemotherapy with olaparib an inhibitor of the PARP enzyme (PARPi).~   "
31822|NCT03150563|"~     Intensity is a qualitative variable of a muscle stretching protocol, which is very little~     studied due to its inherent characteristic of the individual being stretched. However, it was~     pointed out as an important factor for ADM gain. To verify the effects of different~     intensities of static passive stretching on flexibility, neuromuscular and functional~     performance in soccer athletes.~   "
31823|NCT03150550|"~     Among behavioral cognitive psychotherapies, new Mindfulness interventions allow patient to~     identify, pay attention and accept external (sensory stimuli) and internal (cognition and~     emotions) phenomena. This to do with training has yielded promising results in stress~     management, prevention of depressive relapse, management of craving and an increase in~     self-efficacy. Few studies (none in France) have attempted to measure the efficacy of this~     technique on alcohol relapse, in particular by comparing it with a usual management strategy~     (conventional relapse prevention therapy).~      The main objective of this study is to compare the efficacy on alcoholic relapse (measured in~     the first glass consumed), from a Mindfulness therapeutic program to a conventional Relapse~     Prevention program. Secondary objectives are to demonstrate the efficacy of this program on~     craving, self-efficacy, and secondary endpoints of relapse (massive alcoholism, number of~     alcoholisation days).~   "
31824|NCT03150537|"~     80 subjects (healthy adults) will be randomized to receive the seasonal flu vaccine either by~     needle & syringe or by the MIT needle-free injector (Med-Jet MIT H4™ & Disposable Cartridge).~     The study will be conducted after the normal flu season has passed (ie: March-April). Half of~     those randomized to standard vaccination (n=20) will receive vaccine drawn from a multi-dose~     vial while the other half (n=20) will receive vaccine drawn from a single use vial. The same~     vaccine as the multi-dose vial will be delivered to the other half of the subjects (n=40)~     using the MIT injector. How long it takes to prepare and deliver the vaccines will be~     assessed (a time-motion study). Subject acceptance before and after injection will be~     assessed as well as local and systemic side effects. Standard serologic measures of immune~     response to flu vaccination (ie: antibodies) will determine whether the Med-Jet H4 injector~     induces the same kind of immune response as needle & syringe delivery.~   "
31825|NCT03150524|"~     This is a randomized clinical trial of short-acting nimodipine versus twice daily extended~     release verapamil to treat patients presenting with Reversible Cerebral Vasoconstriction~     Syndrome (RCVS).~   "
31826|NCT03150511|"~     The aim of this clinical trial is to assess the efficacy of tesamorelin as a therapy for~     peripheral nerve injuries. The investigators hypothesize that treatment with tesamorelin will~     allow for faster and greater recovery of motor and sensory function following surgical repair~     of injured peripheral nerves. Patients with upper extremity nerve injuries will be randomly~     assigned to receive either the drug or a placebo (inactive drug). A number of tests for nerve~     regeneration, muscle function and sensation will be performed every month for a total of 12~     months. Outcomes in the patients treated with tesamorelin will be compared to outcomes in~     patients who received the placebo to determine the effectiveness of tesamorelin as a therapy~     for nerve injuries.~   "
31827|NCT03150498|"~     This is a single-centre, open-label study in healthy male and non-pregnant, non-lactating~     females. The study will consist of up to 2 parts; the decision to proceed to the optional~     second part will be made following review of Part 1 data.~      Part 1 is a single dose, two period crossover to assess food affect of oral BTD-001.~      Optional Part 2 is a non-randomised, single arm study multi dose design to evaluate PK~     profile of BTD-001~   "
31828|NCT03150472|"~     Ivory Dentin Graft is at least as good as the reference test device (OsteoBiol Gen Os) for~     alveolar ridge preservation following tooth extraction.~      The null hypothesis is that Ivory Dentin Graft and OsteoBiol Gen Os are not equivalent (Gen~     Os is better than Ivory Dentin Graft) and the alternative hypothesis is that the proportions~     in the two groups are equivalent, assuming that the expected difference in proportions is 0.0~     (Ivory Dentin Graft is as good as Gen Os Graft).~   "
31829|NCT03150459|"~     The main purpose of this study is to investigate whether the combination of two different~     drugs, simvastatin and rifaximin, is safe in the treatment of patients with decompensated~     cirrhosis.~      The secondary purpose is to see if this combination results in an improvement in inflammation~     markers in patients with cirrhosis and in an improvement in analytic parameters of~     progression of liver disease.~   "
31832|NCT03150420|"~     This multicenter, randomized, double-blind, placebo-controlled clinical trial will evaluate~     the efficacy and safety of intravenous Sodium Thiosulfate Injection for treatment of acute~     calciphylaxis-associated pain in chronic hemodialysis patients.~   "
31833|NCT03150394|"~     Helicobacter pylori is a Gram-negative bacterium with a helical bacillus shape that it's able~     to penetrate and colonize the stomach mucosal lining by infecting it.~      The eradication treatment of H. pylori is supported by numerous consensus groups worldwide~     and it is generally safe and well tolerated. Standard treatment is based on multiple drug~     regimens. However, its effectiveness has been increasingly compromised due to the emergence~     of resistant strains, as well as poor adherence to treatment. Therefore, it's proposed a~     randomized, double-blind, placebo-controlled study whose aims are:~        1. Determine whether the combination of two probiotic strains of L reuteri (Gastrus) will~          improve gastrointestinal symptoms when associated with four-way therapy (of any type).~        2. Prove whether supplementation with Gastrus (food supplement) versus Placebo is able to~          reduce the gastrointestinal adverse effects of quadruple eradication therapy.~      They will be determined by the GSRS gastrointestinal symptom scale in routine clinical~     practice.~   "
31834|NCT03150381|"~     This study tests evidence-based strategies for weight loss among overweight and obesity~     cancer survivors and family members in rural Alabama.~   "
31835|NCT03150368|"~     This is a study for extended use of ModraDoc006/r in patients with advanced solid tumours,~     available after completed treatment in one of the phase I trials with ModraDoc006/r. The~     primary goal is to explore the safety of extended use.~   "
31836|NCT03150355|"~     hip fractures are common problem specially in elderly population the incidence is increasing~     nowadays because of increased incidence of motor vehicle accidents~   "
31837|NCT03150342|"~     Chest pain and myocardial ischemia are prevailing features in patients with hypertrophic~     cardiomyopathy (HCM). Recently introduced single-photon emission computed tomography (SPECT)~     cameras with solid-state cadmium-zinc-telluride (CZT) detectors have been shown to decrease~     imaging time and improved the imaging quality of gated myocardial perfusion imaging (MPI).~     The investigators also correlate the MPI parameters with echocardiographic parameters. This~     study is to examine the spatial distribution of stress perfusion abnormalities and tissue~     injury in patients with HCM using a CZT SPECT camera.~   "
31838|NCT03150329|"~     This phase I trial studies the side effects and best dose of vorinostat when given together~     with pembrolizumab in treating patients with diffuse large B-cell lymphoma, follicular~     lymphoma, or Hodgkin lymphoma that has come back after a period of improvement or that does~     not respond to treatment. Monoclonal antibodies, such as pembrolizumab block cancer growth in~     different ways by targeting certain cells. Vorinostat may stop the growth of cancer cells by~     blocking some of the enzymes needed for cell growth. Giving vorinostat and pembrolizumab~     together may work better in treating patients with diffuse large B-cell lymphoma, follicular~     lymphoma, or Hodgkin lymphoma.~   "
31839|NCT03150316|"~     This study is to determine the maximum tolerated dose(MTD) and recommened phase 2 dose(RP2D)~     based on dose limiting toxicity(DLT), and to evaluate safety and pharmacokinetics(PK) profile~     of a single agent CKD-581 injection in Combination with Lenalidomide and Dexamethasone in~     patients with Previously Treated Multiple Myeloma.~   "
31840|NCT03150303|"~     Patients receiving long-term oral anticoagulant (defined as duration of treatment of at least~     1 month of Direct Oral Anticoagulant (DAOC) or Vitamin K Antagonist (VKA)) and referred for~     an invasive procedure (oral surgery, implantology or periodontology) to an oral surgeon~     taking part to the study will be included in this prospective observational study.~      The main composite outcome is the occurrence rate of hemorrhagic and/or thromboembolic events~     during the peri-procedural period (between 5 days before surgery plus 30 days after the~     invasive procedure).~      0. The secondary end-points will consist of identifying risk factors for bleeding during the~     peri-procedural period, risk factors for thromboembolic events during the peri-procedural~     period, the peri-procedural management of each treatment (VKA or DOAC), the prescribers~     involved in the possible change of anticoagulant prescription prior the oral surgery All~     outcome events will be blindly adjudicated by a central independent adjudication committee.~   "
31841|NCT03150290|"~     Weight loss is a common phenomenon in ALS. During the course of the disease, difficulty in~     swallowing and mastication can be responsible for a decrease in caloric intake and thus for~     weight loss. However, significant weight loss can also be observed in patients with no~     feeding difficulties. About half of ALS patients have an increase in their resting energy~     consumption, but the origin of this hypermetabolism remains unknown. Brown fat is~     specialized in the production of heat. Unlike white fat that stores excess caloric intakes,~     brown fat consumes energy. In humans, brown fat has long been considered as absent in adults.~     However, recent imaging techniques have been able to detect brown fat deposits in some adult~     subjects. The aim of this study is thus to determine the role of brown fat on energy~     consumption in Amyotrophic Lateral Sclerosis.~   "
31842|NCT03150277|"~     The main purpose of this study will be comparison of acute effects of plyometric and heavy~     resistance exercise on post-activation potentiation~   "
31843|NCT03150264|"~     This study compares the two mechanical ventilation strategies in obese patients undergoing~     bariatric surgery: pressure-controlled ventilation(PCV) and pressure-controlled ventilation~     volume-guaranteed（PCV-VG). This is a randomized controlled trial with a sample size of 140~     patients whose body mass index(BMI) is over 30kg/m².~   "
31844|NCT03150251|"~     One objective of this study is to examine the blood glucose and serum insulin responses over~     2hr elicited by oats soaked overnight in milk compared to Cream of Rice soaked overnight in~     milk and compared to Cream of Rice cooked in water. In addition a second objective of the~     study is to measure subjective ratings of hunger and fullness under the same conditions.~   "
31845|NCT03150238|"~     The project will consist of a multicentre, prospective, observational study with a total~     duration of 24 months. Clinical, endoscopic and ultrasound data will be collected in a~     dedicated database (on IG-IBD Register), which will be used to identify potential clinical,~     endoscopic and ultrasound risk factors of re-operation. These data could be merged into a~     shared score, to stratify patients according to the risk of post-surgical re- operation and~     to define an optimal therapeutic management in the post- operative period. Approximately 220~     adult patients, with a defined diagnosis of CD, who underwent a surgery for CD in the~     previous 6 months will be enrolled.~   "
32079|NCT03147131|"~     The aim of this study is to evaluate periprosthetic bone mineral density (BMD) changes in the~     proximal femur after implantation of the Fitmore compared to the CLS stem.~   "
31846|NCT03150225|"~     The aim of this study is to analyze the impact of physical exercise through a protocol of~     concurrent training in the psychological, physical, hormonal and sexual aspects in middle~     aged men with androgen deficiency in the aging male (ADAM). The study design with randomized~     clinical trial, comprising men in middle age (40 to 59 years) with ADAM, should be divided~     into two groups: 1) Control group (CG); 2) Experimental group (EG). Information related to~     sociodemographic and clinical profile will be collected; Psychological aspects (depressive~     and anxiety symptoms - Hospital Anxiety and Depression Scale ; stress - Perceived Stress~     Scale); Physical acpects (IMC; Percentage of body fat; Abdominal obesity - waist~     circumference in cm; Muscle strength - Biodex System 4 PRO isokinetic dynamometer;~     cardiorespiratory Fitness - Cycle-ergometer - CASE ECG Stress Testing System, General~     Electric Medical Systems, Milwaukee, WI); Hormonal aspects (total and free testosterone -~     blood collection); Sexual Aspect (Sexual satisfaction- International Index of Erectile~     Function); DAEM (scale of symptoms of aging). Apply a physical exercise protocol using the~     functional training method over a six-month period. All information will be collected before~     and after the intervention period. For statistical analysis, use the SPSS statistical~     package, version 20.0. (Kolmogorov-Smirnov or Shapiro-Wilk test) for the selection of~     statistical tests.~   "
31847|NCT03150212|"~     The main objective is to assess the effect of an 8-week daily supplementation with IbSium®~     (probiotic yeast Saccharomyces cerevisiae CNCM I-3856) on the improvement gastro-intestinal~     disorders associated to the type C IBS (constipation predominant).~   "
31848|NCT03150199|"~     The focus of this study is to examine the feasibility, acceptability, and impact of a~     customized, combined positive psychology and motivational interviewing (PP-MI) health~     behavior intervention versus a standard motivational interviewing (MI) intervention in a~     group of patients with type 2 diabetes (T2D).~   "
31849|NCT03150186|"~     This is a European study which is part of a larger research project (TackSHS project) funded~     by the European Union's Horizon 2020 Research and Innovation Programme (Grant Agreement~     681040) and led by the Catalan Institute of Oncology. The main goal of the study is to assess~     the environmental levels of secondhand smoke (SHS) in non-regulated settings such as private~     and outdoor settings of 12 European countries (Bulgaria, France, Germany, Greece, Ireland,~     Italy, Latvia, Poland, Portugal, Romania, Spain and the United Kingdom) representing~     geographical, legislative (country-specific smoke-free policies) and cultural variations~     across Europe.~      This is a multi-country cross-sectional study based on objective environmental measurements~     of SHS levels. Private settings studied are homes and cars and outdoors settings are terraces~     of hospitality venues, children playgrounds and entrances of primary school buildings. A~     total of 1,080 environmental measures of airborne nicotine will be collected. 20~     environmental measures will be collected from homes and each of the outdoor settings for the~     12 countries involved in the study (960 samples). Regarding cars, 60 environmental~     measurements will be collected in two countries (Spain and the UK) (120 samples), which have~     been selected taking into account differences in smoke-free legislation. Further information~     about SHS exposure will be collected for each setting through brief questionnaires or forms.~     Medians and interquartile ranges of nicotine concentrations will be calculated by country for~     each setting studied. Nicotine concentrations will be compared using non-parametric tests~     according to country, socioeconomic status and other determinants of exposure for each~     setting.~   "
31850|NCT03150173|"~     This trial will recruit syringe exchange participants with opioid use disorder in New York~     City and test whether starting buprenorphine treatment at the syringe exchange program is~     more effective than referral to a community health center for buprenorphine treatment.~   "
31851|NCT03150160|"~     The purpose of this study is to determine the incremental intraocular pressure (IOP) lowering~     that is achieved when brinzolamide 1% / brimonidine 0.2%, BID, is used adjunctively to~     travoprost in patients with normal tension glaucoma that may benefit from further intraocular~     pressure lowering.~      Data from this study will result in publications and provide health care practitioners with~     important treatment guidance on the use of brinzolamide 1% / brimonidine 0.2% in this~     clinical setting.~   "
31852|NCT03150147|"~     The overall aim of this proposal is to compare a new state-of-the-art ex-vivo organ~     preservation method with standard ischemic cold static storage of donor hearts in adult~     cardiac transplantation.~      Standard heart preservation before transplantation consists of cold ischemic storage of the~     heart. Clinical studies has shown that the morbidity and mortality risk increases with~     extension of the allograft ischemic time over four hours. For each additional hour the~     mortality risk increase with 25% the first year. This time constrained is costly and results~     in severe logistical problems, leading to loss of transplantable organs.~      Initially six patients will be transplanted with the non-ischemic hypothermic cardioplegic~     perfusion. These will be compared with contemporary control patients transplanted with~     standard ischemic cold static storage. After an interim analysis, the study will become a~     single center, prospective, open, blinded endpoint, randomized, controlled clinical trial~     including 28 patients. The primary end-point is a composite of mortality, primary graft~     dysfunction (PGD), need for extra corporal support, or acute cellular rejection (ACR) within~     30- days post-transplant. PGD and ACR will be accessed blinded.An improved preservation of~     the transplanted organ will reduce the major limitations for survival in the early~     post-transplant period such as non-specific graft failure and acute rejection. Furthermore,~     it will make it possible to increase the donor pool.~   "
31853|NCT03150134|"~     Early reduction of immunosuppressive agents after HLA matched donor transplantation can~     improve the survival of advanced stage acute myeloid leukemia.~      single-center, open clinical study~   "
31854|NCT03150121|"~     Screening programs for high-grade ovarian carcinoma failed to reduce disease-specific~     mortality, since they do not offer early enough detection of the disease. Most cases of high~     grade ovarian cancer develop in the fallopian tubes, hence the universal recommendation for~     high-risk populations (e.g., BRCA1/2 mutation carriers) is to undergo risk-reducing bilateral~     salpingo-oophorectomy (RRBSO) around the age of 40. The aims of this trial are: (1) to~     identify novel early-stage disease biomarkers using liquid biopsies obtained through uterine~     lavage, and (2) to optimize the technique a of uterine lavage and the processing of the~     samples for ultimate implementation as a routine diagnostic test for high risk populations.~   "
31855|NCT03150108|"~     The purpose of this study is to compare how rhPTH(1-84) affects the body between healthy~     adults of Japanese descent and matched, healthy Caucasian adults.~   "
31856|NCT03150095|"~     Ability to adhere to complex medical regimens is critical to achieving successful transplant~     outcomes, as non-adherent patients suffer graft failure and death following transplantation.~     Since potential recipients greatly exceed organ availability, identification of candidates~     who will adhere to complex post-transplant regimens is critically important and emphasized by~     practice guidelines. When selecting candidates for transplant, physicians try to subjectively~     predict post-transplant adherence because, although tools exist to measure current adherence,~     tools that reliably predict future adherence are lacking. Despite rigorous medical and~     psychosocial screening pretransplant, non-adherence rates are high following transplant.~     Therefore, the current approach for predicting future non-adherence is suboptimal,~     subjective, and greatly needs strategies for improvement.~      Pre-transplant self-management abilities represent a marker of future adherence~     post-transplant. Assessing self-management as a means for predicting future adherence has~     been largely overlooked. Self-management is defined as taking responsibility for one's own~     behavior and well-being and consists of three management tasks: medical condition, emotions,~     and social roles. Self-management ability can be measured. However, self-management has not~     been systematically studied in heart and lung transplant patients. Fostering self-management~     abilities may improve post-transplant outcomes by optimizing not only adherence, but also~     proven pretransplant risk factors (e.g. frailty and obesity).Self-management abilities may be~     improved via behavioral interventions such as health coaching.Self-management represents a~     measurable criterion that could be utilized in pre-transplant screening and serve as a point~     of intervention for optimizing adherence and pre-transplant risk factors.The overall~     objective of the proposed research is to improve the knowledge gap regarding self-management~     (and thereby adherence) in transplant by qualitatively and quantitatively studying patient~     factors associated with self-management and testing an intervention that may improve~     self-management.~      The investigators hypothesize: Individualized health coaching including strategies to address~     poor resilience, coping with uncertainty, frailty, and/or negative affect will be an~     effective therapeutic strategy at improving self-management while in the pre-transplant~     state.~      Specific Aim: To test whether transplant candidates who receive pre transplant health~     coaching have greater improvement in self-management abilities.~      The investigators will conduct a randomized, controlled pilot trial testing the effectiveness~     of health coaching versus usual care in a heart and lung transplant cohort on self-management~     abilities (SMAS-30).~   "
31857|NCT03150082|"~     This two-period cross-over study will evaluate bioequivalence of GR37547 (ciprofloxacin 500~     mg) tablet versus ciprofloxacin 500 mg reference tablet in healthy adult subjects under~     fasting conditions. Subjects will receive Treatment A (GR37547 tablet) and Treatment B~     (ciprofloxacin reference tablet) in crossover manner, separated by a washout period of at~     least 7 days and not more than 14 days. The total duration of study for each subject will be~     approximately 5-7 weeks. This study will enroll approximately 26 healthy adult subjects at a~     single center.~   "
31858|NCT03150069|"~     The present study seeks to interview women with Morquio A and Morquio B syndrome, to explore~     their concerns surrounding pregnancy and the impact of ERT on their perspectives, in~     comparison with the control group of Morquio B subjects for whom no ERT treatment exists.~      Interviews will be conducted by a health psychologist, in-person or over the telephone. Data~     will be analyzed using MAXQDA 12.0 software and Grounded Theory. Differences in thematic~     trends between Morquio A subjects, for whom treatment exists, and a control group of Morquio~     B subjects, for whom there is no treatment, will be compared.~   "
31859|NCT03150056|"~     The study aims to evaluate the combination of GSK525762 with other agents that have been~     shown to be effective in the treatment of CRPC or metastatic CRPC, including approved agents~     (e.g., abiraterone, enzalutamide) as well as investigational agents for mCRPC that have~     proven to show efficacy and can be combined based on complimentary mechanism of action. As a~     first step, the combination of GSK525762 will be evaluated as a combination with abiraterone~     or enzalutamide in men with metastatic or advanced castrate-resistant prostate cancer who~     have progressed on at least one line of prior androgen receptor (AR)-targeted therapy. This~     study is designed to determine the maximum tolerated dose (MTD) and recommended Phase II dose~     (RP2D) based on safety, tolerability, pharmacokinetic, and efficacy profiles of GSK525762 in~     combination with either abiraterone (Arm A) or enzalutamide (Arm B). Arm A and Arm B will~     further have 2 cohorts: A1, A2 and B1, B2 respectively based on prior lines of therapy (L2~     [chemo-naive subjects treated with a second androgen-deprivation therapy] and Lx [subjects~     treated with both prior androgen-deprivation therapy and chemotherapy]). During dose~     escalation, both the treatment arms (A and B) will follow a modified Toxicity Probability~     Interval (mTPI) design. Approximately 130 subjects will be enrolled worldwide in this study.~     Subjects from both dose escalation and dose expansion may be combined to reach 30 subjects.~     The total duration of study will be approximately 2 to 3 years. A subject will be considered~     to have completed the study if they are followed until death.~   "
31860|NCT03150043|"~     A non-invasive hemoglobin monitor will be used during cesarean delivery and the values~     obtained will be compared to values obtained from traditional blood draw.~   "
31861|NCT03150030|"~     Twenty-one patients with insulin-treated type 2 diabetes with diabetic complications will be~     recruited to Part 1 of the study, a three-hour combined hyper- and hypoglycaemic clamp, along~     with a control group of twenty-one individuals with normal glucose tolerance matched for age,~     gender, and body mass index. Patients with type 2 diabetes will be scheduled for a three-week~     run-in period with LR and CGM prior to participation in Part 1. Only patients with a~     well-functioning loop-recorder and who can comply with CGM will be included. Patients with~     type 2 diabetes will continue in part 2 of the study, a one year observational study~     employing CGM and LR and clinical examination after 1, 3, 6, 9, and 12 months and an extended~     observation period of 2 years employing LR and clinical examination.~   "
31862|NCT03150017|"~     To establish the effectiveness of an internet-delivered cognitive behavioural therapy pain~     management programme (CBT-PMP) on people with spinal cord injury pain compared with usual~     care.~   "
31863|NCT03150004|"~     This is a prospective phase II clinical study to be conducted at the Medical College of~     Wisconsin. After meeting the study criteria and enrollment, patients will be treated with~     CLAG-M chemotherapy and followed at periodic intervals to determine the primary and secondary~     objectives.~   "
31864|NCT03149991|"~     This is a multi-site, double-blind, placebo-controlled study of the acute efficacy of~     brexpiprazole or placebo in combination with intranasal ketamine added to ongoing, stable,~     and adequate antidepressant therapy (ADT) in the treatment of adults with Major Depressive~     Disorder with Treatment Resistant Depression.~   "
31865|NCT03149978|"~     This study suggested an effective application of pattern recognition, which figured the~     possible biological function of potential bio-markers of rectal cancer found in our study~     based on their chemical structures. Hence, this study identified the precursor protein and~     metabolic mechanism of these bio-markers and may contribute to the neoadjuvant chemoradiation~     of locally advanced rectal cancer~   "
31877|NCT03149822|"~     This study is designed to evaluate the combination of pembrolizumab and cabozantinib in~     subjects with locally advanced, recurrent, or metastatic renal cell carcinoma that has~     progressed after treatment with at least one prior VEGF-targeted therapy, or for whom~     VEGF-targeted therapy has proven to be intolerable, or is considered inappropriate.~   "
31866|NCT03149965|"~     The hypothesis was that the anovaginal distance (AVD), defined as the distance between the~     anal mucosa and the vaginal wall at the middle level of the anal canal, is higher in obese~     women compared with normal weight women. Measuring the AVD with transperineal ultrasound has~     been shown to have a high interobserver agreement.~      This study aimed to establish if there was a difference in AVD measured by transperineal~     ultrasound between obese and normal weight women in active phase of labor at term pregnancy.~     The second aim was to present normal values for the AVD in active phase of labor at term~     pregnancy.~   "
31867|NCT03149952|"~     Hospitalization for allogeneic haematopoietic stem cell transplantation constitutes a~     particular time in the management of patients with malignant hemopathies both for the~     patient, for his entourage or for the nursing staff. For the patient, the strict protective~     isolation set up during this period is a source of isolation in the broad sense and is~     associated with an escape from external events and society. It also constitutes a physical~     barrier (mask, charlotte, surblouse and overshoes worn by caregivers or visitors) and even~     psychological in relations with relatives. Moreover, this period is also difficult because of~     the possible complications of conditioning (mucositis, transit disorders, fever ...) and~     allograft itself (graft versus host disease, no transplant, relapse disease…). The patient~     may be weakened and diminished, which can give a feeling of helplessness and uselessness to~     the family. Finally, this therapy can have serious physical and psychological consequences~     for the patient and his entourage (especially in the case of family allograft) who do not~     always have the possibility to express themselves verbally. Published studies in hematology~     report depressive, anxious and post-traumatic stress disorders in patients and relatives~     during allogeneic haematopoietic stem cell transplantation. It is therefore important to~     reduce these symptoms, particularly those related to the cut-off during hospitalization for~     allogeneic haematopoietic stem cells.~      Over the last decade or so, the logbook has been used in some resuscitation services in~     intubated patients, with the main objective of filling the memory gap mentioned by the~     intubated patients when they woke up and limiting the trauma associated with this Cut in the~     world corresponding to the sedation period. For this purpose, the use of a logbook in~     Hematology, by analogy with what is used in the resuscitation services, could be a means of~     limiting the psychological complications related to the allograft.~   "
31868|NCT03149939|"~     Hyperuricemia is not infrequently encountered among hemodialysis patients. However, there is~     no clear data about use of febuxostat among hemodialysis patients, apart from very small case~     series. The aim of this study is to investigate the efficacy of using febuxostat for the~     treatment of Hyperuricemia among hemodialysis patients.~   "
31869|NCT03149926|"~     The current study investigates the emotional response of patients with borderline personality~     disorder and healthy controls on stimuli associated with self-injury.~   "
31870|NCT03149913|"~     Patients with claudication or critical limb ischemia will be treated either with uncoated~     balloons or paclitaxel coated balloons in order to enhance the vessel patency in stenosed or~     occluded below the knee arteries~   "
31871|NCT03149900|"~     To identify possible genetic associations of clinical response to anti-IL-17A (Secukinumab)~     treatment in psoriasis using a combined gene association study and gene expression analysis.~      To investigate the influence of IL-17A on the cutaneous microbial flora and to analyse~     cutaneous antimicrobial peptide expression in the skin of patients with psoriasis prior to,~     and during, treatment with Secukinumab to determine the extent to which the microbial flora~     is associated with response to treatment, as determined by the PASI75, PASI90, PGA- and DLQI~     improvement.~   "
31872|NCT03149887|"~     Liposomal bupivacaine, a long-acting form of bupivacaine, has been found to be effective for~     postoperative pain control after total knee, total hip and total shoulder arthroplasty. We~     are conducting a randomized, controlled trial to evaluate pain control after arthroscopic~     rotator cuff repair in ambulatory patients, comparing standard care in the control group,~     with standard care plus the addition of injection of liposomal bupivacaine in the~     experimental group.~   "
31873|NCT03149874|"~     The aim of this study is to examine the result of seroprotection using the accelerated~     vaccination schedule in vaccination of hemodialysis patient through using combined hepatitis~     A and B vaccine.~   "
31874|NCT03149861|"~     Background:~      Currently, patients suspected of having prostate cancer undergo ultrasound-guided systematic~     biopsies of the prostate. However, up to a quarter of clinically significant tumors, which~     may pose a risk to patient's well-being, may be missed on random biopsies. MRI enables~     detection of further tumors in this patient population, but also has limited accuracy.~      Study hypothesis:~      We hypothesize that hybrid PET-MRI, a novel scanner which incorporates MRI with molecular~     imaging will improve the detection rate of clinically significant tumors.~      Study design:~      In this prospective trial, we will recruit 57 men who are suspected of having prostate cancer~     but have had negative systematic biopsies, who have been diagnosed with low-risk disease but~     have clinically signs of more aggressive tumor or who have a focal tumor detected and are~     candidates for minimally-invasive tumor ablation (=tumor destruction with laser or ultrasound~     waves), in whom it is crucial to exclude other tumor sites.~      All patients will undergo PET/MRI after injection of a radiopharmaceutical called~     18F-DCFPyL. This is a radioactive probe which has been shown in preliminary studies to be~     sensitive and specific for detection of prostate cancer.~      All lesions detected on PET/MRI will undergo biopsy under ultrasound using fused PET/MRI and~     ultrasound images for guidance, and compared to histopathology. The primary outcome measure~     in this study is the proportion of clinically significant prostate cancers that are detected~     with PET/MRI compared to MRI alone. Improved detection of clinically significant prostate~     cancer may enable a tailored, personalized therapeutic approach, decreasing morbidity and~     potentially improving overall patient outcome.~   "
31875|NCT03149848|"~     This is a Phase I, single-center, open-label, fixed-sequence, 2-period crossover study in~     healthy adults to evaluate the effect of oral rifabutin (RBT) 300 milligram (mg) on the~     pharmacokinetics of oral cabotegravir (CAB) 30 milligram ( mg). This study will evaluate the~     drug-drug interaction (DDI) potential between CAB and RBT to inform dosing strategies for~     tuberculosis in subjects receiving CAB for human immunodeficiency virus (HIV) treatment or~     prevention. In Treatment Period 1 (Treatment A) participants will receive CAB 30 mg once~     daily for 14 days, followed by Treatment Period 2 (Treatment B) where participants will~     receive RBT 300 mg once daily with CAB 30 mg once daily for 14 days. The total study duration~     will be approximately for 10 weeks. Approximately 15 healthy subjects will be enrolled to~     ensure that 12 subjects complete dosing and critical assessments.~   "
31876|NCT03149835|"~     Objectives: Investigate the acute NIV effects on CBF and cognitive functions in COPD~     patients. Methods: Nine non-hypercapnic stable COPD subjects (FEV1/FVC < lower limit of~     normal) and twelve healthy controls were enrolled. CBF (transcranial Doppler), cognitive~     functions, respiratory and cardiovascular response were tested at baseline, during and after~     non-invasive ventilation.~   "
31878|NCT03149809|"~     The impact of urinary symptoms in Parkinson disease (PD) extends beyond worsened well-being.~     Urinary symptoms common in PD, especially incontinence and nocturia, are major risk factors~     for falls likely due to the combination of urinary urgency and impaired mobility (and falls~     are a leading cause of mortality in PD), for spouse/caregiver stress due to decreased~     mutuality in the relationship, and for institutionalization, largely due to increased~     disability. Additionally, most medications currently recommended for urinary symptoms in PD~     are anticholinergic and have the potential to worsen the progressive cognitive and autonomic~     burdens of the disease. Veterans with PD are also more likely to rely solely on VA for their~     health care than Veterans without PD. Thus, optimizing the care of urinary symptoms for~     Veterans with PD becomes imperative, particularly for VA. Using a non-inferiority design,~     this proposal seeks to demonstrate the comparative effectiveness of pelvic floor muscle~     exercise-based behavioral therapy versus drug therapy to treat urinary symptoms in PD.~   "
31879|NCT03149796|"~     The investigators propose to identify changes in cytokines like adipocytokines and microRNA~     (miR) expression (for example miR-9, miR-16, miR-125, miR-132, miR-146a, miR-150, miR-155,~     miR-181 and miR-223) in peripheral blood leukocytes and in serum samples obtained from~     rheumatoid arthritis (RA) patients before and after tocilizumab treatment. The results~     obtained will be compared to gender- and age-matched healthy controls, and will help the~     investigators define one or more miRNAs as biomarkers for treatment effectiveness.~      Methods The investigators will obtain blood samples from 60 RA patients treated with~     tocilizumab, according to the local clinical guidelines. Blood samples will be collected~     before treatment, as well as one and four months following tocilizumab treatment. The blood~     samples will initially undergo microarray analysis and then the results will be confirmed for~     specific miRNAs by quantitative real-time PCR (qPCR). The serum level of the tested~     cytokines, like adipokines, will be measured using ELISA methods. The changes in cytokines~     level and miRNAs expression, either up-regulation or down-regulation, during tocilizumab~     therapy will be correlated to the severity of the disease and to specific demographic and~     medical data. The results obtained will be compared to 60 healthy controls gender- and~     age-matched~   "
31880|NCT03149783|"~     A randomized controlled trial to determine if pre- and post- operative regional pain control~     (transversus abdominis plane block) with ropivacaine versus placebo leads to lower anesthetic~     and narcotic dosing, and alters pain scores.~      This study plans to learn more about regional anesthesia and pain control during abdominal~     surgery. The study will gather data about the effectiveness of continuous catheter infusion~     of local anesthetic after an abdominal operation. Outcomes include pain scores, IV pain~     medicine requirements, and delirium.~   "
31881|NCT03149770|"~     The overall objective of this project is to determine if the intranasal administration of~     naloxone during exercise will be a novel approach to preserve the counterregulatory response~     to hypoglycemia experienced the next day in patients with type 1 diabetes. Exercise induced~     autonomic failure contributes to the development of impaired awareness of hypoglycemia.~     Treatments that blunt the consequences of exercise induced autonomic failure, such as~     preserving the post-exercise counterregulatory response to hypoglycemia, may improve~     awareness of hypoglycemia. Naloxone, an opioid antagonist, is an extremely promising agent.~     In healthy volunteers, intravenous administration of naloxone during exercise preserved the~     counterregulatory response to hypoglycemia the following day (1). In this study,~     investigators will extend the clinical applicability by administering intranasal naloxone to~     individuals with type 1 diabetes. Specifically, the investigators will use a randomized,~     placebo controlled, crossover design to administer drug or placebo to patients with type 1~     diabetes during acute exercise and assess the counterregulatory response to hypoglycemia the~     following day. The use of intranasal naloxone is a highly innovative aspect of this proposal.~     Intranasal naloxone translates readily to clinical use and, as demonstrated by the~     investigators preliminary data, achieves similar plasma drug concentrations as after IV~     administration.~   "
31882|NCT03149757|"~     YouTHrive (YT) is a two-arm randomized control trial (RCT) to test the efficacy of an adapted~     version of the Thrive With Me (TWM) intervention for youth living with HIV (YLWH). In the~     RCT, intervention participants will have access to the full YouTHrive (YT) website- a~     mobile-enhanced private social networking website aimed at improving medication adherence for~     YLWH. The investigators will enroll up to 60 YLWH for formative work on YT, and 300 YLWH~     (15-24 years old) of all genders with a detectable viral load (VL) across six cities and~     randomize them to either the intervention condition or control condition. Assessments will be~     collected at baseline, 5, 8, and 11-month follow-up.~   "
31883|NCT03149744|"~     This investigation is looking at a currently available technology to see if it could have~     another use i.e. in helping to diagnose patients with sleep apnoea.~      With 2-4% of the population suffering from this disease, and the current wait time for a test~     at approximately 20 weeks, it is hoped that a simple screening method could help speed up the~     process of finding these patients and getting them on treatment faster.~      The current standard of care test involves a sleep study in the patients own home with a~     device with multiple parts and wires. The RespiraSense Sleep Screener is completely cableless~     and consists of one small, discrete unit attached to the patients side and a mobile device~     plugged in by the bed.~      Patients at Queen Alexandra Hospital who are prescribed sleep studies will be invited to~     participate. The RespiraSense Sleep Screener data is only for comparison purposes and will~     have no effect on their clinical care.~      If patients agree to participate they will undergo the sleep study with both devices in the~     same night and may be followed up with over the phone on their experiences with the test.~   "
31894|NCT03149601|"~     Adults with obesity have an imbalance of bacteria in their intestines which may contribute to~     weight gain and diseases related to obesity. Restoring the balance of these bacteria (the~     microbiota) could help reduce weight and related diseases. However, little is known about~     this imbalance in children with obesity. This research study will map out the compositions of~     the gut microbiota of children and compare them with those of children who have healthy~     weights and different degrees of obesity. This project will also measure the amounts of fatty~     acids in the stools which are an indication of how efficiently the intestines absorb calories~     from food. If an imbalance is detected in children with obesity, then this information can~     help researchers test ways to restore the gut microbiota with hopes of reducing weight and~     some of its related health problems.~   "
31884|NCT03149731|"~     Near-infrared spectroscopy (NIRS) functions in a manner similar to pulse oximetry, using the~     difference in absorptive qualities of oxy- and deoxyhemoglobin to infrared light to quantify~     the percent saturation. There is also available evidence shows that tissue oximetry is~     sensitive and has a quicker response to physiological derangement, such as bradycardia, in~     preterm newborns. Additionally, it is demonstrated that reduced postoperative cerebral tissue~     oxygenation index variability in neonatal survivors of congenital heart disease surgery with~     poor neurodevelopmental outcomes. The SafeBoosC phase II randomized clinical trial~     hypothesizes that the burden of hypo- and hyperoxia can be reduced, and consequently the risk~     of brain injury, by the combined use of close monitoring of the cerebral rStO2 and an~     evidence-based treatment guideline to correct deviations in rStO2 outside a predefined target~     range. In this study, we will monitor 2 different tissue beds including cerebral and~     abdominal somatic tissue rStO2 and SpO2 in neonates. Further research is needed to~     investigate clinical implications for using this measure to drive therapeutic interventions.~   "
31885|NCT03149718|"~     Opioid medication misuse and overdose have reached epidemic proportions in the US. Community~     pharmacy is a potentially valuable resource for addressing opioid medication misuse. This~     study will manualize and establish the feasibility, acceptability, and clinical effect of a~     community pharmacist-led intervention aimed at: improving opioid mediation regimen adherence,~     eliminating misuse, connecting patients to additional care, and safeguarding against~     overdose.~   "
31886|NCT03149705|"~     Ischemic stroke is the first cause of acquired disability of the adult, the second cause of~     dementia and the third cause of death in the industrialized countries, what constitutes à~     major public health issue. Stroke is characterized by a cerebral parenchymal lesion due to an~     ischemic mechanism (85% of the cases) or hemorrhagic mechanism (15%). For a long time, the~     only approved treatment was the intravenous thrombolysis (rt-PA). Recently, thrombectomy has~     proven its superiority in this pathology.~      Cohorts of patients with stroke are rare but can be very valuable by their clinical,~     laboratory and imaging well documented. They are the source of new hypotheses for research or~     interventions as well as the quality of care assessment tool.~      The main objective of this project is to identify new markers: biological and imaging,~     treatment response and prognosis after ischemic stroke.~      Secondary objectives of the HIBISCUS-STROKE cohort are to establish a clinical database,~     completed by biological samples and by imaging data that can be used in the following areas:~        -  Descriptive epidemiology of ischemic stroke and cerebral reperfusion,~        -  Pharmacoepidemiology and treatments observatory: safety, efficacy, indication of~          treatment in real life, costs~        -  Assessment of the long-term effect of the treatment on the occurrence of disability,~          stroke recurrence and death,~        -  Quality of life and personal, familial, professional and social consequences of stroke,~        -  Research of new diagnostic and prognostic biomarkers,~        -  Research projects.~   "
31887|NCT03149692|"~     One case of unsuccessful penile transplantation has been reported from China. The patient had~     suffered an industrial machine accident and lost his penis to the level of the pubic skin.~     Unfortunately the patient's wife insisted at about two weeks post-operatively that the organ~     be removed. At the time of surgical removal the penis was viable, except for a degree of~     superficial skin necrolysis. This has sparked debate on ethical issues regarding penile~     transplantation. South Africa is uniquely positioned in Sub-Saharan Africa and worldwide with~     relatively advanced medical services and a high prevalence of ritual circumcision practice~     with reports of high morbidity and mortality in the last 20 years. The substantial number of~     young men left with a severe penile defect or complete loss of the penis [9] creates a~     possible place for penile allograft transplantation as a treatment option.~   "
31888|NCT03149679|"~     Single center, open labeled, phase 2 clinical trial, where patients with metastatic~     colorectal cancer are selected for treatment with dose dense Cyclophosphamide every second~     week based on TP53 mutation status; i.e. only patients with TP53 mutated tumors may be~     included in the treatment arm.~   "
31889|NCT03149666|"~     Although taste influences food choices and favours diseases like obesity, there is no~     consensus about the existence of correlations between bitterness and anthropometric~     variables. Also, an electronic-based method for data collection could provide a more~     appropriate way for the evaluation of taste perception and save time.~      The objective is to search for correlations between bitterness and anthropometric variables.~   "
31890|NCT03149653|"~     The aim of this study was to evaluate the safety and tolerance of ClinOleic or Lipoplus or~     SMOFlipid lipid emulsions. After 6 weeks of each lipid emulsion, Omegaven (fish oil) was~     added for a further 4 weeks. The safety and tolerance was evaluated after each lipid emulsion~     cycle by biochemistry, hematology and coagulation variables, vital signs and adverse events.~     We also analysed fatty acid profiles in plasma or erythrocyte phospholipids, antioxidant~     enzyme activities, lipid peroxidation products, plasma lipids and pro-inflammatory cytokine~     production after in vitro stimulation of whole blood by lipopolysacharide in HPN patients.~     The non-interventional group of healthy controls was included for comparison.~   "
31891|NCT03149640|"~     The objective of the study is to prove that after the third day of invasive mechanical~     ventilation a three-day course of inhaled amikacin reduces the incidence of subsequent VAP.~      Parallel two group double blind randomized controlled clinical trial. Individual~     randomization, performed on day 4 of invasive mechanical ventilation, will be stratified on~     centre in order to account for variations in VAP prevention bundle implementation and use of~     systemic antibiotics the day of randomization. Patients will be treated three consecutive~     days with inhaled amikacin or placebo. Patients will be followed up daily in the intensive~     care unit for the occurrence of VAP according to international guidelines until day 28.~   "
31892|NCT03149627|"~     The purpose of this study is to recruit a random and representative sample of individuals~     within several Zambian communities for markers of Hepatitis B Virus (HBV) and to characterize~     chronic HBV infection and indications for treatment.~   "
31893|NCT03149614|"~     The aim of this study is to compare the clinical effects of spinal mobilization versus~     vertebral resonant oscillation (POLD) in patients with bilateral mechanical neck pain on pain~     sensitivity and neck pain intensity.~   "
32440|NCT03142399|"~     The aim of this study is evaluate the effect of whey protein supplementation on muscle mass~     preservation, improvement of strength and quality of life, and inflammatory parameters in~     patients with heart failure NYHA I or II followed by a cardiac rehabilitation program.~   "
31895|NCT03149588|"~     Sevoflurane and propofol are the most popular drug choices for maintenance of general~     anaesthesia for caesarean section. However, effects of these two anesthetics on maternal and~     fetal outcomes after caesarean section haven't been compared directly. The aim of this study~     is to compare the effects of sevoflurane and propofol as maintenance of general anesthesia,~     and to try to determine which anesthetic is better for maternal and fetal outcomes after~     caesarean section.~   "
31896|NCT03149575|"~     This is an adaptive design, randomized controlled, Phase 3 clinical trial in patients with~     glioblastoma multiforme (GBM) or gliosarcoma (GS), previously treated with surgery (if~     appropriate), standard of care chemo-radiation with temozolomide, +/- adjuvant temozolomide,~     and bevacizumab and now has progressive disease during or after bevacizumab.~      A total of up to 180 eligible patients with recurrent/progressive GBM or GS will be~     randomized to receive either the investigational drug (VAL-083) or Investigator's choice of~     salvage therapy as a contemporaneous control, in a 2:1 fashion. Up to 120 eligible patients~     will be randomized to receive VAL-083 at 40 mg/m2 IV on days 1, 2, and 3 of a 21-day~     treatment-cycle, for up to 12, 21-day treatment cycles or until they fulfill one of the~     criteria for study discontinuation. Up to 60 patients will be randomized to receive~     Investigator's choice of salvage therapy, limited to temozolomide, lomustine, or~     carboplatin, until they fulfill one of the criteria for study discontinuation. The dose level~     for Investigator's choice salvage therapy (temozolomide, lomustine, or carboplatin), will be~     in accordance with the product label or institutional guidelines.~      In both study arms, interval medical histories, targeted physical exams, neurologic~     evaluations, complete blood counts, and other laboratory and safety assessments will be~     performed approximately every 21-days while receiving treatment. Tumor assessments are to be~     performed approximately every 42 ± 7 days while remaining on study. The study is estimated to~     last approximately 20 months.~   "
31897|NCT03149562|"~     Although lacking strong evidences, plasma transfusions are commonly used in critically ill~     neonates. To date, the relationships between plasma transfusions and nosocomial infection~     remain controversial and no study has reported the relationships between plasma transfusion~     and invasive fungal infection (IFI)~   "
31898|NCT03149549|"~     The purpose of this first-in-human study of CX-2009 is to characterize the safety,~     tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-2009~     in adult subjects with metastatic or locally advanced unresectable solid tumors. PROCLAIM:~     PRObody CLinical Assessment In Man CX-2009 clinical trial 001~      PROBODY is a trademark of CytomX Therapeutics, Inc~   "
31899|NCT03149536|"~     In this study, the investigators will evaluate genetic variation or polymorphisms between~     individuals submitted to IVF/ICSI cycles, and how these variations influence response to COS~     and pregnancy outcomes. Thus, this project has the aim to develop a pharmacogenetic algorithm~     associating gene polymorphisms, the patient clinical information, and functional and hormonal~     biomarker to: 1) predict the patient response to gonadotropin; 2) develop individualized~     gonadotropin regimens; 3) improve the accuracy of determining appropriate dosages of~     gonadotrophins; 4) improve efficacy and patient compliance to COS; and finally 5) reduce the~     time-to-pregnancy.~   "
31900|NCT03149523|"~     Over the last 10 years, technological advances in molecular biology enabled a more accurate~     genomic characterization of tumors. For each tumor location, this led to the identification~     of subgroups with similar molecular characteristics. This identification allowed the~     development of targeted therapies and thus to improve the patient prognosis. This molecular~     characterization has also revealed the tumor heterogeneity. It may be the cause of treatment~     resistance and therefore of relapses. Additionally, tumor cells are in constant dialogue with~     their microenvironment composed of different immune or non immune cells. This~     microenvironment is now targeted in cancer treatment.~      To date, there are few studies that combine a deep genomic characterization of both tumor and~     tumor microenvironment of the patient. Combining the two types of studies on the same tumor~     should help to define new therapeutic targets and should allow a combination of targeted and~     immunomodulatory therapies. To this end, our project is to conduct an exhaustive integrated~     exploratory analysis at genomic, transcriptomic and immunological levels of 3 tumor types (in~     colon, kidney and liver cancer).~   "
31901|NCT03149510|"~     In the United States, about 40 percent of heart failure (HF) patients are readmitted within~     1-year following their first admission for HF and hospitalization accounts for approximately~     70 percent of the costs of HF management. As a result, the management of HF patients is~     evolving from the traditional model of face-to-face follow-up visits toward a proactive~     real-time technological model of assisting patients with monitoring and self-management while~     in the community. The investigators plan to test the impact of a mobile application on~     clinical outcomes in HF.~   "
31902|NCT03149497|"~     Classic management of cervical spine sublaxation and dislocation is combined anterior and~     posterior approach. Unfortunately there are disadvantages for this approach like: increasing~     morbidity related to each approach, increasing surgical costs, increasing operative time as~     well as the risk of blood loss.~      Anterior approach has the advantages of supine position, less surgical trauma and direct~     anterior decompression of neural elements. Disadvantages include less mechanical stability~     and postoperative dysphagia.~   "
31903|NCT03149484|"~     The purpose of this research study is to learn about the hearing outcomes of children with~     conductive hearing loss who are treated with bone conductive devices and their outcomes with~     remote microphone technology.~   "
31904|NCT03149471|"~     The aim of this study is to investigate the association between endothelial dysfunction,~     measured by RHI as assessed by the peripheral arterial tonometry method, and PE complications~     defined as re-event of PE or DVT, systemic embolism or all-cause mortality~   "
31935|NCT03149068|"~     Inflammation begins during early stages of CKD in which neutrophil counts are increased,~     whereas lymphocyte counts are decreased during inflammation. In addition to known~     conventional indications of inflammation such as C-reactive protein (CRP), fibrinogen,~     erythrocyte sedimentation rate, several interleukins and tumor necrotizing factor alpha,~     Neutrophil-to-lymphocyte ratio (NLR) has increasingly been reported as a measure of systemic~     inflammation (Okyay G U et al 2013 and Yilmaz G et al ,2017) Several recent studies have~     shown that mean platelet volume (MPV) is also increased during inflammation and may be~     associated with poorer prognosis in CKD (Yilmaz G et al ,2017).~   "
31905|NCT03149458|"~     The majority of hemiparetic patients have balance disorders, which impact independence in~     daily living activities and walking. Conventional techniques used in rehabilitation improve~     balance but have shown no effects on dynamic balance required during walking. Recently dance~     is proposed to improve dynamic balance in older people and people with Parkinson's disease.~     Although many studies showed that dance is an effective activity to improve balance in these~     people, it has never been assessed in hemiparetic patients (except a case report). The aim of~     this study is to show that a dance program improves the balance of hemiparetic patients,~     compared to a control group. This randomized controlled study aims to include 40 hemiparetic~     patients who will perform a dance program (experimental group) or a upper-limb rehabilitation~     program (control group) for 8 one-hour sessions.~   "
31906|NCT03149445|"~     Two-centre, double-blind, placebo-controlled, randomized, and multiple-dose clinical study.~   "
31907|NCT03149432|"~     The aim of this study is to assess the efficacy of the mirror therapy on phantom pain for~     patients with amputation after vascular etiology. the secondary aim are to measure the impact~     of the mirror therapy on quality of life, sleep disorders, and predictive factors for~     effectiveness. the design is a prospective study, randomised, blindly evaluated, monocentric.~     There will be 2 groups: 1) rehabilitation and gabapentine; 2) rehabilitation and gabapentine~     + mirror therapy during the first 4 weeks. The assessment are going to be preformed at the~     inclusion day and then every 2 weeks during 8 weeks. the primary evaluation criterion will be~     the phantom pain measured on a VAS. the delay for inclusion is 18 months in order ton include~     40 patients. The length of the study is 20 months.~   "
31908|NCT03149419|"~     Hot flashes, vasomotor symptoms that affect many postmenopausal women, are associated with~     cardiovascular disease and endothelial dysfunction. Estrogen therapy, associated or not with~     progestogens, is the standard treatment for vasomotor symptoms and improves the endothelial~     function of postmenopausal women with hot flushes, even those with cardiovascular risk~     factors, such as hypertension. It is not known whether hot flushes are a cause for the~     development of endothelial dysfunction or are markers of this dysfunction, evidenced by~     estrogen deficiency, thus representing primitive target organ (vessel) lesion. Paroxetine was~     approved by the FDA as a non hormonal treatment for menopausal hot flashes. In this~     double-blind randomized clinical trial, the vascular effects of paroxetine at a dose of 7.5~     mg / day, compared to placebo, during 12 weeks are evaluated.~   "
31909|NCT03149406|"~     Carotid stenosis of atherosclerotic origin may be responsible for stroke, which is one of the~     most important causes of morbidity and mortality in the Western world. The constitution of~     the atheroma plaque is linked to the deregulation of several biological phenomena, including~     angiogenesis, adipogenesis, inflammatory response, lipid metabolism and oxidative stress. In~     addition to its anatomical and physiological characteristics, the notion of plate stability~     is of paramount importance for clinical implications. This stability depends largely on the~     biological composition of the plate. A vulnerable or unstable plaque often has a large lipid~     body consisting of foam cells (macrophages laden with oxidized LDL) with a thin fibrous~     screed consisting of smooth muscle cells (CML), collagen fibers and extracellular matrix.~     This plaque is also made up of numerous inflammatory cells including macrophages, rich~     vascularization and intraplate hemorrhage. Although the cell composition of the unstable~     plate is still relatively established, its molecular analysis remains little known.~      The benefit of carotid surgery in asymptomatic patients with stenosis greater than 70% is~     increasingly controversial given the moderate risk of spontaneous stroke under optimal~     medical treatment. This annual average risk is less than 5%. Thus, the discovery of an~     original and innovative biomarker, predictive of plate rupture, would define the patients~     most at risk, who benefit most from this surgery.~   "
31910|NCT03149393|"~     This study is a randomized, double blind, double dummy, multicenter, parallel controlled~     clinical trial, the investigators objective is to evaluate the efficacy and safety of Qizhi~     Weitong granules in the treatment of functional dyspepsia.~   "
31911|NCT03149380|"~     To evaluate the effectiveness of an online educational course on Alzheimer's disease (AD)~     prevention, treatment and caregiving.~   "
31912|NCT03149367|"~     Comparison of the results of levator resection operation with the use of fixed sutures~     technique in which the levator muscle is approached through skin incision and the muscle~     shortened and sutured directly to the tarsus then the skin crease reformed with interrupted~     sutures which pick up the underlying levator muscle versus the results with the use of~     adjustable sutures in which the suture passes through the levator muscle into the tarsal~     plate and out through the skin edge .the skin crease is formed separately so that adjusting~     the suture doesn't open the wound, the suture can be adjusted according to the result up to 4~     days post operative.~   "
31913|NCT03149354|"~     Since the appearance of high-efficiency anti-retrovirals (HAARTs) in the treatment of Human~     Immunodeficiency Virus (HIV), several studies have shown an increase in the prevalence of~     hypothyroidism (frank, rough or low hypothyroidism T4) in cohorts of HIV-infected adults and~     children. More specifically, rough hypothyroidism (increased TSH and normal thyroid~     peripheral hormones) have a prevalence of about 3-12% in HIV-treated patients, which is~     higher than the general population of about 4.3%. The etiology of frustrated hypothyroidism~     remains debated in the literature; Effects of antiretroviral therapy (ARV) such as~     Stavudine®, the effect of dyslipidemia, the effect of HIV infection itself, in proportion to~     severity (expressed as low CD4 cell count) and AIDS stage. Thyroid dysfunction does not~     appear to be of autoimmune origin, as anti-peroxidase antibodies are rarely present in~     HIV-infected patients, unlike the general population.~      With the increased life expectancy of HIV-infected patients and the indications of different~     experts to be treated earlier, the duration of exposure to ARVs is also increasing.~     Therefore, their chronic toxicity deserves particular attention, in particular on thyroid~     function and / or thyroid hormone metabolism, since iatrogenicity has not been completely~     ruled out. In addition, clinical evidence suggests that dysthyroids may be corrected or~     worsened over time in HIV patients (unpublished personal data).~      Today, the natural history of frustrated hypothyroidism and its consequences are not reported~     in patients infected with HIV. However, it is recognized in the elderly, fructified~     hypothyroidism evolves over time towards frank hypothyroidism; The latter is associated with~     an increased prevalence of dyslipidemia, atherosclerosis, diastolic hypertension and~     therefore an increased risk of myocardial infarction.~      It therefore seems interesting to review the evolution of thyroid function in HIV-infected~     patients, with sufficient follow-up.~   "
31914|NCT03149341|"~     The purpose of this study is to (1) quantify cardiovascular anatomy and physiology using~     magnetic resonance imaging under both resting and exercise conditions in patients who have~     congenital heart disease and in age-matched normal volunteers, (2) use computer models to~     reproduce and simulate blood flow in these patients, and then (3) to combine the imaging data~     and computer models to estimate values which cannot be directly measured and to predict~     physiological changes induced by exercise and medical or surgical therapies.~   "
31915|NCT03149328|"~     People living with end-stage kidney disease (ESKD) need dialysis or transplantation in order~     to stay alive. This illness and treatment significantly impact peoples' health, emotions,~     work and relationships. To promote person-centred care, healthcare professionals should be~     asking patients about what matters to them and using this feedback to plan and deliver care.~     Patient-reported outcome and experience questionnaires (jointly referred to as PROs) allow~     patients to provide information about their quality of life, symptoms and experiences with~     care. PROs are increasingly used to help healthcare professionals learn about what is~     important to patients and the impacts of illness or treatments from patients' point of view.~     Embedding feedback from patients into routine clinical practice is important in end-stage~     kidney disease because of the physical and quality of life challenges these patients face~     when living with kidney failure.~      PROs provide vital and often missing information that the healthcare team can use to support~     patients. However, PROs administered via paper questionnaires have been perceived as~     cumbersome, difficult to integrate with other health information and do not provide immediate~     feedback.~      In this research, home dialysis patients will have the opportunity to complete electronically~     administered PROs (ePROs) and healthcare professionals will receive education about how to~     use PRO information. The goal is to learn how to support healthcare professionals to~     routinely use this information to inform patient care, and see if this makes a difference in~     patients' symptoms, person-centred care, quality of life and satisfaction with care.~      Learning what matters most to patients is essential for healthcare professionals to provide~     person-centred care. This research will address the gap in our understanding of how to best~     use patients' reports in healthcare. Findings of this research may ultimately improve the~     quality of healthcare for Canadians living with end-stage kidney disease.~   "
31916|NCT03149315|"~     This is a phase II open label study on the use of Ibrutinib on the inhibition of food-induced~     anaphylaxis in adults with food allergy. Ibrutinib (brand name Imbruvica) is currently FDA~     approved for the treatment of mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL),~     and Waldenstrom's macroglobulineia (WM). We propose to administer this approved drug to~     adults with food allergy to inhibit food allergy responses.~   "
31917|NCT03149302|"~     The sensorimotor disturbance and postural instability have been demonstrated to be associated~     with neck pain. Specific therapeutic exercise and manual therapy for the cervical spine are~     effective interventions for improving dizziness symptoms, neck impairments, functional~     ability and quality of life. However, the effects of these interventions on the actual~     impairment of joint position sense and balance remain uncertain. Adaptive changes in the~     sensorimotor and postural control systems may need to be specifically addressed.~   "
31918|NCT03149289|"~     Progression of liver fibrosis in patients with hemoglobinopathies is strongly related to the~     severity of iron overload and the presence of chronic hepatitis C virus (HCV) infection.~     Effective iron chelation therapy and HCV infection eradication are efficacy to prevent liver~     complications. EASL and AASLD guidelines recommend interferon-free regimens for the treatment~     of HCV infection in patients with hemoglobinopathies. However, data regarding the use of~     direct-acting antiviral drugs (DAAs) in this patient population are very few This large,~     observational study evaluated the safety and efficacy of standard therapy with DAAs in a~     large Italian cohort of with hemoglobinopathies, chronic HCV infection and advanced liver~     fibrosis.~   "
31919|NCT03149276|"~     A systematic literature review from March through June 2014 supports the premise that limited~     English proficiency (LEP) persons face barriers and disparities to medical care that~     English-speaking persons do not face. Language barriers have a negative impact on health and~     health care, including lower health status, lower likelihood of having a primary care~     provider, lower rate of preventative care, higher use rate of diagnostic tests, higher rate~     of severe psychopathology diagnoses, and higher risk of drug complications . Additionally,~     LEP persons experience problems with effective communication with providers, inappropriate~     diagnoses and treatments, lower comprehension of medication instructions and adherence to~     regimens, fewer follow up visits, low quality care, poorer health outcomes, and low patient~     satisfaction.~      Research has proven a relationship between LEP and health care outcomes, specifically a~     relationship between positive outcomes and use of professional interpreters. Not sharing a~     common language creates a barrier to providing safe, effective, client-centered Occupational~     Therapy (OT) and knowledge of outcome satisfaction for this population. Using trained~     interpreters would reduce the barriers created by language discordance.~      This evidence-based project intends to measures the influence of interpreter service on LEP~     patients' perceived quality of care using a satisfaction survey. Gathered data will be used~     to consider development and implementation of practice guidelines for use of professional~     interpreter services for LEP patients receiving OT services at Midwest Orthopaedics at Rush.~     Development and implementation of practice guidelines that include use of trained~     interpreters when providing OT services to LEP patients will facilitate a client-centered~     approach and improve quality of care for this population.~      The project is also being implemented as part of a degree requirement for the Doctorate of~     Occupational Therapy Program at Chatham University.~   "
31920|NCT03149263|"~     In children requiring botulinum toxin injections, improving supervisory procedures of~     injection sessions to reduce pain and improve the experience of this invasive procedure is~     needed. The intervention of medical clowns seems very interesting in this goal, but its~     effectiveness has not been proven within the botulinum toxin injections. The objective of the~     study is to evaluate in terms of profit the presence or absence of clowns during a session of~     botulinum toxins by determining their impact on pain and anxiety felt among children and~     their carers~   "
31921|NCT03149250|"~     The study aims to investigate the impact of preeclampsia on hemostasis.~   "
31922|NCT03149237|"~     The purpose of this R01 proposal is to evaluate the clinical impact, hypothesized mechanisms~     of behavior change, and cost-effectiveness of a partners-focused integrated elimination of~     mother-to-child transmission of HIV (EMTCT) package comprised of: 1) antenatal care-based~     couples HIV testing, ART enrollment, and care for sero-concordant HIV+ expectant couples; (2)~     Couples-based treatment in the post-partum period; (3) Couple-based education and skills~     building; and (4) Treatment continuity with the support of expert-patient (peer) supporters~     from couples who have successfully navigated EMTCT. This innovative approach to scaling up~     EMTCT services, if proven feasible and effective, will be adopted in President's Emergency~     Plan for AIDS Relief (PEPFAR) programs to accelerate progress toward EMTCT and helping~     families with HIV infection live long, healthy lives.~   "
31923|NCT03149224|"~     The purpose of this study is to characterize specific brain signals elicited by motor~     disturbances and errors in stroke patients. The patients will perform a motor task using both~     their affected and unaffected hands. There are two types of errors: low level errors and high~     level errors. While disturbances (low level errors) have been shown to elicit P300,~     uncorrectable actions (high level errors) have been shown to elicit ERN. These event related~     potentials (ERP) have been extensively studied in healthy subjects including a recent paper~     from our Lab.~   "
31924|NCT03149211|"~     The purpose of this phase III study is to evaluate the efficacy, safety and tolerability of~     UB-421 monotherapy in suppressing viral rebound in HIV-1 infected adults undergoing~     antiretroviral treatment interruption.~   "
31936|NCT03149055|"~     The purpose of this study is to study the effects of isavuconazole in preventing fungal~     infections in patients who have had a hematopoietic stem cell transplant (HCT).~   "
32494|NCT03141697|"~     In this double-blind, randomised and controlled study 150 Patients referred to colonoscopy~     were assigned to either CO2 or air insufflation. We recorded basic characteristics of~     colonoscopy and the amount of drugs used for sedation. Patients and investigators filled out~     questionnaires to record pain, abdominal bloating and flatulence.~   "
31925|NCT03149198|"~     Introduction: Physical exercises have been recommended to improve overall well-being in~     patients with fibromyalgia, with the main goal of repairing the effects of lack of physical~     conditioning, and improving symptoms especially pain and fatigue. Very well estimated and~     widely known are the studies that support the use of the pilates method as effective in~     improving the symptoms of the disease.~      Objective: To evaluate the effectiveness of the soil method in improving pain in women with~     fibromyalgia in the city of Santa Cruz, RN.~      Methodology: This is a randomized controlled trial with blind evaluator, where 60 patients~     with fibromyalgia diagnosis are divided into two groups. The intervention group, perform an~     exercise program based on the pilates method in soil and another, considered control group,~     participate in a program of aerobic exercises in the pool. Both groups conduct supervised~     exercise programs 2 times a week for a period of 12 weeks. The evaluation instruments used in~     an EVA (visual pain scale); FIQ Questionnaire - Fibromyalgia Impact Questionnaire; Functional~     ability by the Timed Up and Go test and 6-minute walk test; A quality of sleep by the~     Pittsburgh Sleep Quality Index (PSQI-BR) and an ESS-BR (Epworth Sleepiness Scale); Finally, a~     general quality of life for the SF-36.~      Statistical analysis: Data are analyzed by t-student, Mann-Whitney test, repeated-measures~     ANOVA and intention-to-treat analysis.~   "
31926|NCT03149185|"~     The purpose of this study is to examine the effects of various factors such as emotions,~     stress, stress management techniques (for example relaxation and coping techniques), and~     health information on quality of life, distress, depression, coping, and physical health in~     men diagnosed with advanced prostate cancer. We also evaluate the effectiveness of a 10-week~     group-based internet delivered psychosocial intervention. Primary outcomes are symptom burden~     (e.g., urinary function, fatigue, pain) and HRQOL (e.g., general, physical & social~     functioning).~      Participation in this study includes three face-to-face assessments: baseline (at the~     beginning of the research study), 6-month follow-up, and 12-month follow-up. The 6- and~     12-month follow-up interviews are conducted after the participant has completed the 10-week~     group intervention. Participants are randomized into either an intervention group (targets~     stress management skills - relaxation, coping) or a control group (health information and~     health promotion strategies - benefits of proper nutrition and treatment compliance). Both~     groups meet for 10 consecutive weeks through an internet video conferencing platform.~      At the baseline, 6- and 12-month follow-ups, we collect blood and saliva samples. The blood~     samples go through a three-day process in which we extract and store serum, plasma, and cells~     for further analysis and gather proliferation data. We use the saliva to measure the cortisol~     diurnal rhythm.~   "
31927|NCT03149172|"~     The purpose of this pilot study is to conduct a interventional prospective clinical trial to~     evaluate the efficacy of three different xenografts for ridge preservation by comparing the~     quality of newly formed bone using histomorphometric and micro CT analysis.The three~     xenograft materials under investigation are Bio-Oss® (bovine derived xenograft), Equimatrix®~     (equine derived xenograft), and Endobon® (bovine derived xenograft). There are no prospective~     studies comparing the effectiveness of these three materials, Bio-Oss®, Endobon® and~     Equimatrix®, when placed in extraction sockets.~      Participants will be recruited from patients in the TUSDM clinics that require extraction of~     single rooted non-molar tooth and are treatment planned to receive dental implants in the~     future. Participants will be randomized to receive one of the three xenograft materials after~     tooth extraction. The percentage of newly formed bone and bone density will be compared~     between the three materials 4-6 months after ridge preservation.~   "
31928|NCT03149159|"~     The purpose of this study is to see if continued nivolumab with the addition of ipilimumab~     plus hypo-fractionated stereotactic radiation (sTR) of a single lesions results in partial or~     complete responses in patients with metastatic ccRCC who fail initial treatment with single~     agent nivolumab.~   "
31929|NCT03149146|"~     This study aims to improve the Clinical Decision Making (CDM) skills of a group of Myanmar~     physical therapists by series of educational workshops that will introduce them to and guide~     them through the decision making process by using the CDM workbook. Participants will be~     separated into two groups, CDM workshop group and CDM workbook group. There will be three~     time assessments; one pre-workshop/ workbook and two post-workshop/workbook assessments by~     using Clinical Decision Making (CDM) assessment worksheet.~   "
31930|NCT03149133|"~     Occlusive or ischemic training is a type of strength training which is becoming more and more~     popular every day. The safety, efficacy and detailed description about the use of occlusive~     training is well documented in the literature. However, the effects on hypertrophy and the~     stiffness of the muscle tissue are not studied. We aimed to measure these changes by~     ultrasound technology in a randomized controlled design.~   "
31931|NCT03149120|"~     This trial will assess whether nivolumab alone or nivolumab combined with pazopanib will be~     associated with an improvement in progression free survival (PFS) at 6 months~   "
31932|NCT03149107|"~     Schizophrenia is a severe mental disorder associated with significant impairments in~     affective, cognitive and social functioning. Consequently, a special interest in the~     prevention of schizophrenia and psychotic disorders has emerged. Pharmacological as well as~     psychological interventions show promising preventive effects. The purpose of this~     multicentric study is the investigation of possible preventive effects of a treatment~     combination containing a psychotherapy form and medication (N-Acetylcytein - NAC) in~     individuals with an enhanced risk for developing schizophrenia. Both treatment forms may~     reduce the risk in this population due to their specific properties: The psychotherapy can~     improve social skills, whereas NAC is supposed to develop its protective effects on neuronal~     level due to its antiinflammatory properties. The investigators will examine the preventive~     effects by measuring transition rates to psychosis after treatment as well as improvements in~     social, affective and cognitive functioning.~   "
31933|NCT03149094|"~     The purpose of this study is to create a smartphone, tablet and web-based application to help~     people deal with stress. Stress often increases fatigue in people with HIV infection, so~     successfully dealing with stress could help reduce HIV-related fatigue. The study is being~     done at one site, the Medical University of South Carolina. Approximately 30 people will take~     part in this portion of the study.~   "
31934|NCT03149081|"~     The purpose of this study is to determine whether oral administration of Boswellia causes~     biological changes in primary tumors of breast cancer and colon cancer patients.~   "
31937|NCT03149042|"~     Coronary Computed Tomography Angiography (CCTA) contrast opacification gradients and FFR-CT~     estimation can aid in the severity estimation of significant atherosclerotic lesions.~     Currently, FFR-CT algorithms can only be optimized using theoretical models and can only be~     validated in large multi-center clinical trials. Using patient specific 3D printed coronary~     phantoms would allow optimization of FFR-CT algorithms with a measured validation technique~     without the need for large clinical trials. Thus we believe that this study will result in a~     FFR-CT algorithm/method with a better predictability for arterial lesion severity than those~     existing on the market today. Flow measurements will be compared with: CT-FFR for both~     patients and phantoms, angio lab FFR measurements and 30 days follow-up. This pilot clinical~     study will include ~50 patients over a year and half at GVI.~   "
31938|NCT03149029|"~     This research study is studying a combination of drugs as a possible treatment for~     unresectable or metastatic melanoma.~      The drugs involved in this study are:~        -  Pembrolizumab (Keytruda)~        -  Trametinib (Mekinist)~        -  Dabrafenib (Tafinlar)~   "
31939|NCT03149016|"~     We aim to assess the treatment outcomes following upper incisors retraction accelerated by~     corticotomy procedure. So, we intend to randomize orthodontic patients with class II division~     I malocclusion into two groups: experimental group and control group. Both groups will start~     orthodontic treatment. Once a 0.019*0.025-inch stainless steel wire is fully engaged to the~     brackets, 1st premolars will be extracted. Canines will be retracted in the conventional~     manner. Then, the actual evaluation period starts when the upper incisors are retracted using~     two different methods.~   "
31940|NCT03149003|"~     This is a randomized, active-controlled, multicenter, open-label, parallel groups, Phase 2~     study of DSP-7888 Dosing Emulsion plus Bevacizumab versus Bevacizumab alone in patients with~     recurrent or progressive glioblastoma multiforme (GBM) following treatment with first line~     therapy consisting of surgery and radiation with or without chemotherapy.~   "
31941|NCT03148990|"~     Measles and rubella are highly contagious acute viral diseases. As per WHO, several evidences~     demonstrate the benefit for providing the universal access to vaccines containing measles and~     rubella antigens, mainly due to, respectively, mortality in children and malformations in~     fetuses. This is a Phase I-III, Controlled, randomized and double blind for the evaluation~     double viral vaccine anti-measles and rubella (MR), which is developed and produced at~     Instituto de Tecnologia em Imunobiologicos Bio-Manguinhos/Fiocruz, in Brazil, for use in~     human beings. 432 eligible volunteers (11-month-old infants), will be vaccinated and~     monitored for local and systemic adverse events and titration of antibodies. The study will~     last 11 months in total.~   "
31942|NCT03148977|"~     The objective of this study is to determine whether our chemical assay can be used to~     reliably predict graft take or failure in patients undergoing autologous skin grafting for~     treatment of acute burn injury.~   "
31943|NCT03148964|"~     Open, prospective, multicenter French cohort study enrolling subjects aged of 15 years or~     more, during or immediately after HIV-1 primary infection. This cohort was organized from the~     outset to be highly multidisciplinary, bringing together immunologists, virologists,~     clinicians and epidemiologists.~   "
31944|NCT03148951|"~     In the planned study the investigators want to evaluate the relation between postoperative~     Visual Analogue Scale(VAS) scores, complications and minor/ major morbidities, mortality and~     Mean Platelet Volume (MPV) and Neutrophil/ lymphocyte (N/L) ratio.~   "
31945|NCT03148938|"~     Multiple Sclerosis (MS) is a chronic immune-mediated inflammatory disease with a broad~     diversity of symptoms and fluctuating progression patterns. Clinical assessments are~     challenging and are continually reviewed and enhanced. Optimal multiple sclerosis care~     depends on early detection of disease progression. The Digital self-Assessment for Multiple~     sclerosis (DAM) mobile program was developed by Ad Scientiam in order to create a robust and~     clinically validated remote monitoring platform for MS patients and clinicians. The~     correlation between DAM version 0 (the first iteration of DAMS) and Multiple Sclerosis~     Functional Composite (MSFC) has been clinically evaluated in a preliminary study in 30~     subjects. DAM version 0 and MFSC global scores were correlated. However, the cognition test~     had a poor reproducibility and clinicians expressed the wish to measure a walking range~     rather than a walking speed. Even though vision is the main sense impacting all other tests,~     particularly when interacting with a mobile, visual tests are rarely performed in real life.~     A new version of DAM version 0, DAMS, was therefore developed with the addition of the Sloan~     Low Contrast Letter Acuity Test (SLCLAT), the replacement of the walking speed test with a~     walking distance test and the Paced Auditory Serial Addition Test (PASAT) by a new version of~     the cognitive test which resembles the Symbol Digit Modalities Test (SDMT).~      The hypothesis is that systematic and prospective multi-dimensional data collection of MS~     disabilities through the DAMS mobile application will refine the quality and accuracy of both~     clinicians and patients' knowledge of the disease progression and will ultimately improve the~     current care of patients.~      To test this assumption, the statistician will analyze:~        1. The global diagnostic performance of DAMS with (DAMS 4 tests) and without (DAMS 3 tests)~          the low contrast vision test versus standard MS scales~        2. The test-retest reliability of DAMS' scores at a 15 day interval~   "
31946|NCT03148925|"~     The purpose of this study is to evaluate the safety and pharmacodynamics of SELA-070.~     Increasing subcutaneous doses of SELA-070 will be administered to healthy smoker volunteers.~     The resulting safety profile and anti-nicotine antibody levels will be evaluated.~   "
31947|NCT03148912|"~     Multicentre (Ottawa and Halifax) prospective cohort study using a diagnostic approach in~     patients clinically suspected to have HIT that combines pretest probability assessment with~     quantitative interpretation of anti-PF4 assay.~   "
31948|NCT03148899|"~     In human volunteers intranasal administration of oxytocin significantly increases~     parasympathetic and decreases sympathetic cardiac control. OSA is a very prevalent disease~     with high cardiovascular risk factors, yet this disease remains very poorly treated.~      This proposal, based on the current literature and new basic science results detailed above~     on the role of oxytocin in cardiovascular control, will test if oxytocin administration~     improves adverse cardiovascular events during the recurrent nocturnal apneas in patients with~     OSA. This project will lay the groundwork and provide preliminary data to obtain NIH funding~     to test this important hypotheses more thoroughly and in larger clinical trials.~      This study will explore if intranasal oxytocin has any positive cardiovascular benefits in~     patients with sleep apnea.~   "
31956|NCT03148795|"~     The purpose of this international, phase 2, open-label, response rate study of talazoparib is~     to assess the efficacy and safety of talazoparib in men with DNA repair defects metastatic~     castration-resistant prostate cancer (CRPC) who previously received taxane-based chemotherapy~     and progressed on at least 1 novel hormonal agent (enzalutamide and/or abiraterone~     acetate/prednisone).~   "
31949|NCT03148886|"~     About 5% of breast cancers are metastatic at diagnosis and 20-30% of localized breast cancer~     become secondarily metastatic.Thanks to recent therapeutic advances, the median survival~     ranges between 12 months in 1970 and 18 to 24 months in 2000. However, patients suffer from~     many detrimental symptoms such as fatigue, pain related to treatment and metastasis. The~     physical, biological, psychological and clinical benefits of physical activity (PA) during~     treatment in patients with localized breast cancer have been widely demonstrated. Numerous~     studies investigated the effect of PA in non-metastatic breast cancer, but to our knowledge,~     only four interventional studies worldwide focused on the implementation of PA in patients~     with metastatic breast cancer.It seems appropriate to investigate the feasibility of PA~     intervention with patients with metastatic breast cancer to see if the observed effects in~     localized breast cancer are confirmed in metastatic breast cancer population. The ABLE study~     is an interventional cohort designed to assess the feasibility of a 6-month adapted physical~     activity intervention, performed under real life conditions in patients with metastatic~     breast cancer.~   "
31950|NCT03148873|"~     Your respiratory rate is your number of breaths per minute. The standard way for this to be~     measured is by a nurse looking at you for one minute and manually counting your breaths over~     this time. They normally do this once every few hours. At times, it can be useful to have~     your respiratory rate continuously monitored. A device that can do this is a capnograph. For~     the patient, this involves wearing a tube in their nose and around their ears while trying to~     minimise their movement and talking so the measurements can be taken.~      This research study is looking at a new respiratory rate monitor and comparing how well it~     works against the current accepted methods.~      Patients who are admitted to the Acute Medical Unit will be invited to participate should~     they meet all eligibility criteria.~      Subjects will be monitored for two hours:~      (i) For the first hour subjects will wear a capnograph, RespiraSense and have their~     respiratory rate manually counted by a research nurse. During this time the subject will be~     asked to keep talking and moving to a minimum.~      (ii) For the second hour subjects will wear RespiraSense and have their respiratory rate~     manually counted by a research nurse. During this time the subject can talk and move as they~     wish.~   "
31951|NCT03148860|"~     Methotrexate (MTX) co-medication can improve the therapeutic effect of biological therapies~     (e.g. Tumor necrosis factor (TNF) -inhibitors) in rheumatoid arthritis (RA), but its role in~     Psoriatic Arthritis (PsA) remains unclear.~      No data from Randomized Clinical Trials (RCTs) are available to address the questions whether~     add-on of MTX to UST monotherapy, or a withdrawal of continuous MTX therapy in patients with~     newly initiated Ustekinumab (UST) treatment or simultaneously induction of MTX with UST in~     naive active PsA-patients will influence outcome measurements.~      So, the purpose of the study is to analyse the effects of blinded MTX-co-medication on~     outcome in patients treated with UST: Non-inferiority at week 24 of UST monotherapy compared~     to add-on to MTX in patients with active PsA and at least 12 weeks of MTX treatment prior to~     screening or who are actually not treated with MTX and do not have prior inadequate response~     to MTX-treatment for PsA will be demonstrated.~   "
31952|NCT03148847|"~     The prevalence of heart failure is estimated to 2.3 percent of the adult population and~     strongly increases with age, according to french disability-health surveys. In France, more~     than 32,000 annual deaths are attributable to heart failure and the five-year survival rate~     is similar to those found in many cancers. A better therapeutic management (angiotensin~     converting enzyme inhibitor and beta-blockers) helped reduce mortality after an episode of~     heart failure requiring hospitalization, but, nevertheless it remains high.~      The severity of cardiogenic pulmonary edema depends on several factors such as etiology,~     hemodynamic status, effect on hematosis, and fatigue.~      It is important to note that cardiogenic pulmonary edema initial management is decisive. In~     addition, early and adapted management of cardiogenic pulmonary edema is associated with a~     shorter hospital stay and reduced hospital mortality.~      The Coronary Emergency Network (RESURCOR) within the Northern French Alps Emergency Network~     (RENAU) is an emergency care system structured in the departments of Isère, Savoie and Haute~     Savoie. Its main goal is to help improve emergency management by using regional good practice~     guidelines (www.renau.org). In this context, projects aiming to evaluate professional~     practices are developed regularly. Since emergency management of cardiogenic pulmonary edema~     has not been evaluated, the Northern French Alps Emergency Network offers an approach to~     improve professional practices by defining and disseminating guidelines on cardiogenic~     pulmonary edema management which will then be assessed.~   "
31953|NCT03148834|"~     Reperfusion therapy in acute myocardial infarction saves viable myocardium, but paradoxically~     reestablishment of coronary artery flow also induces damage and cell death, decreasing the~     full benefit of reperfusion in terms of reduction of infarct size and preservation of~     ventricular function . Myocardial reperfusion can in itself produce more damage and cell~     death, this process defines the phenomenon of reperfusion injury, which could be prevented by~     applying additional therapies.~   "
31954|NCT03148821|"~     Participants in the study will be adults with full mobility, with the capacity to give~     informed written consent. The investigators will recruit a group of volunteers in order to~     represent a variety of BMIs, in an attempt to gain a sample of the BMIs found in the~     population. The investigators will mimic current practices and standard equipment in order to~     replicate real conditions as closely as possible.~      Participants will lay on the following surfaces in the following scenarios~        1. Ambulance scoop: supine (lying flat on their back)~        2. A&E trolley: supine~        3. Hospital bed: supine~        4. Theatre table: supine~        5. Theatre table: Left lateral (lying on their left side at 90 degrees to the operating~          table) with pelvic binders (pads designed to keep the hip immobile).~      Each participant will remain in each position on that particular surface for a period of 25~     minutes. A pressure mapping mattress will lie between the participant and the surface~     assessed to generate a pressure map.~      Following completion of data collection, data will be analysed and any areas of potential~     pressure damage vulnerability will be identified.~   "
31955|NCT03148808|"~     The NVS Therapy is being studied to evaluate the safety and efficacy of retention of acute~     luminal gain, leading to acute hemodynamic improvement in superficial femoral and popliteal~     arteries with reference vessel diameters between 3.5 and 7.0 mm and lesion lengths between 36~     and 96mm. The system is intended for use in patients with de novo lesions in the superficial~     femoral and proximal popliteal arteries.~   "
31957|NCT03148782|"~     Organizational, time management and planning (OTMP) skills deficits are seriously impairing~     features of developmental disorders, such as Attention Deficit Hyperactive Disorder (ADHD)~     and autism, which compromise school performance and family relations. The manualized~     Organizational Skills Training program (OST) was designed to target children's specific OTMP~     deficits. However, the brain mechanisms of treatment-induced changes remain unknown. The~     current study combines a training intervention with non-invasive MRI imaging in a~     pre-/post-design to address this question.~   "
31958|NCT03148769|"~     Bacteremia~      The Hypothesis of the study are the followings:~        -  To demonstrate relevant epidemiologic and clinical changes with potentially impact in~          the management and prognosis of the patients with bacteremia.~        -  Since the diagnosis and management is heterogeneous between centers, we could identify a~          scenario to improve.~        -  To identify quality indicators in the management of bacteremia.~        -  To demonstrate that some interventions made by Bacteremia Team pose relevant impact in~          the prognosis of bacteremia.~   "
31959|NCT03148756|"~     This study will compare dalbavancin to standard of care (SOC) antibiotic therapy for the~     completion of therapy in patients with complicated bacteremia or infective endocarditis.~   "
31960|NCT03148743|"~     With the stem cell transplanting increasing, patients which effected with gut GVHD were also~     increased. To evaluation the safety and efficacy of FMT for gut GVHD,patients with gut GVHD~     were recruited.~   "
31961|NCT03148730|"~     This study will be the first study to report the combined use of three independent~     closed-loop systems together to assist clinicians in titrating anesthesia, analgesia, fluid~     and optimize ventilation in frailty old patients undergoing moderate to high risk surgery.~     The potential benefits of optimizing the control of these variables by advanced closed loop~     systems are two-fold. Firstly, this will likely decrease the variance of delivered care and~     reduce deviation from the established standards, resulting in improved post operative~     cognitive outcomes in elderly patients. Secondly, this would establish a precedent that~     automated intraoperative systems have strong clinical significance and are more than~     complicated toys, which is unfortunately how they are perceived now.~      Hypothesis: Automated control of anesthetic depth (minimal episodes of overly deep or light~     anesthesia) and hemodynamics (via improved volume administration) can decrease the occurrence~     of postoperative cognitive dysfunction in elderly patients undergoing moderate to high risk~     surgery (Better MOCA test in the postoperative period compared to the manual group [+ two~     points in average])~   "
31962|NCT03148717|"~     This prospective double-blind placebo-controlled randomized clinical trial will be conducted~     at Ain-Shams University Maternity Hospital from April 2017 till December 2017. Group 1 women,~     candidates for cesarean section, will receive preoperative rectal 400 microgram of~     misoprostol, and Group 2 women will receive postoperative rectal 400 microgram of~     misoprostol.~      2017. 120 women candidate foe elective cesarean section will receive preoperative sublingual~     400 microgram of misoprostol, and another 120 women will receive postoperative sublingual 400~     microgram of misoprostol.~   "
31963|NCT03148704|"~     Observe palonosetron hydrochloride capsules'(Ruo Shan®) safety and efficacy information in~     the real world using.~   "
31964|NCT03148691|"~     The primary objective of this study is to evaluate the safety and effectiveness of 2~     concentrations of A-101 compared to Vehicle for the treatment of 4 seborrheic keratosis (SK)~     Target Lesions on the trunk, extremities and face.~   "
31965|NCT03148678|"~     The overall goal of the outlined study is to scrutinize and to promote mindfulness via new~     technologies using a combination of smartphone-based assessment and micro-interventions, fMRI~     and real-time fMRI-neurofeedback.~   "
31966|NCT03148665|"~     The purpose of this study is to test the ability of OncAlert™ to screen for cancer and the~     reappearance of cancer. OncAlert™ was developed by Vigilant Biosciences, a collaborator in~     this research study. OncAlert™ is an oral rinse which is spit into a cup and sent to a~     laboratory for analysis. OncAlert™ is considered experimental by the FDA because it is not~     approved for the screening of cancer.~   "
31967|NCT03148652|"~     Cigarette smoking is a leading cause of morbidity and mortality in the United States. Among~     individuals who engage in smoking cessation treatment, attrition rates remain high. Many~     smokers experience difficulties in regulating their emotions, which reduces their ability to~     benefit from standard interventions and leads to increased smoking behaviors. In addition,~     cognitive deficits (e.g., reduced working memory capacity) may prevent smokers from applying~     information from interventions, making smart choices about the benefits and risks of smoking,~     and resisting smoking advertisements.~      This study will test whether adding a working memory training and motivational enhancement~     component to a standard, evidence-based cognitive behavioral therapy-based smoking cessation~     program (SCP) can improve treatment adherence and successful quit rates. This study will~     compare 5 sessions of SCP with an additional wellness-focused component (control~     intervention) to SCP incorporating motivational enhancement and working memory training~     (enhanced intervention). Participants will be adult smokers recruited from the greater~     Boston community who are interested in quitting smoking. This study will determine the~     efficacy, acceptability, and feasibility of the enhanced intervention.~   "
31968|NCT03148639|"~     Treatment of verbal hallucinations in schizophrenia is clinically challenging for both the~     patient and the therapist. For the therapist, one of the main difficulties arises from the~     impossibility of directly communicating with the entity persecuting the patient. For the~     patient, the therapeutic process is challenging because it aims at getting to better cope~     with an entity that keeps repeating stereotyped and abusive sentences without having the~     emotional strength to reply to the persecutor. To help overcome these clinical challenges,~     virtual reality enable patients to recreate the face and the voice of their persecutor.The~     hypothesis is that the engagement of patients in a dialogue with an external representation~     of their persecutor, with the support of the therapist, would help them to gain better~     control over their voices.~   "
31992|NCT03148301|"~     Spina Bifida can lead to physical neurocognitive and psychological symptoms. Still little is~     know about the daily impact of spina bifida on participation possibilities in social life.~     This exploratory research project want to investigate which lif choices patients with spina~     bifida has to make and in which way their daily life is organized. In a second part, quality~     of life will be measured and we hope to discover some dynamics in order to improve patient~     care.~   "
31969|NCT03148626|"~     A triad of exhaustion, depersonalization and inefficacy, physician burnout is an epidemic~     among trainees associated with delivering poor quality care. Training programs are desperate~     for evidence-based programs that can prevent burnout during residency. Mindfulness training~     programs can reduce burnout among primary care physicians, but have not been tested during~     physician training. Pilot testing of a novel mindfulness curriculum during pediatric~     internship was found to be feasible to implement.~      The primary objective of this study is to determine if implementing a novel 6-month~     mindfulness curriculum comprised of seven 1-hour sessions can reduce physician burnout and~     increase mindfulness practice and empathy. A multicenter cluster randomized controlled trial~     will be conducted among interns training in programs of various sizes and regions to address~     this objective. The investigators hypothesize that completing a mindfulness curriculum during~     internship will reduce interns' levels of physician burnout and increase their mindfulness~     practice and empathy.~      Within pairs in pediatric residency programs matched on size (a proxy for burnout), clusters~     of interns in each program will be randomized to experience either the mindfulness curriculum~     over a 6-month period (intervention) or receive the usual educational curriculum (control).~     During a 15-month study period, burnout, mindfulness and empathy will be assessed using~     validated measures at baseline, 6- and 15-month follow-up. The impact of the intervention~     will be determined by comparing physician burnout, empathy and mindfulness scores between~     interns in the intervention and control groups. This methodologically rigorous multi-center~     cluster RCT will determine if implementing an innovative 6-month mindfulness curriculum~     reduces pediatric interns' burnout and improves empathy and mindfulness practice.~   "
31970|NCT03148600|"~     Multi-centre, assessor-blinded, randomised controlled trial comparing physiotherapist-led~     behavioural intervention (including pelvic floor muscle training) to standard care, in the~     management of post-operative ileo-anal pouch patients.~   "
31971|NCT03148587|"~     This study aims to investigate the ability of participants to perform and accurately~     interpret the multi-level pregnancy test and the low sensitivity pregnancy test following~     medication abortion, without routine provider contact.~   "
31972|NCT03148574|"~     Bleeding is still the major cause of mortality and morbidity in postpartum period. World~     health organization has reported 585000 deaths for pregnancy each year. Twenty five percent~     of cases die from post-partum bleeding. Mean amount of blood lost is 500 ml during normal~     vaginal delivery, 1000 ml in cesarean section, and 3500 ml during cesarean section with~     emergency hysterectomy~   "
31973|NCT03148561|"~     Miscarriage is defined as the spontaneous loss of a pregnancy before 24 weeks' gestation,~     that is, before the fetal viability. The clinical signs of miscarriage are usually vaginal~     bleeding associated abdominal pain and cramping . The miscarriage is named 'complete' or~     'incomplete' according to whether or not tissues are retained in the uterus. If a woman has~     minimal bleeding but her cervix is closed, this is known as a 'threatened miscarriage.~     However; if the pregnancy is still inside the uterus but the cervix is open, this is~     described as an 'inevitable miscarriage', which it will not usually be possible to save the~     fetus.~      From many years, the surgical curettage ('evacuation of the uterus') was considered the 'gold~     standard management' for miscarriage to remove the retained placental tissue. It is quickly~     performed and removed almost all the retained products of conception. However, the routine~     surgical evacuation of the uterus associated with higher rate of morbidity and mortality and~     should be limited for special indications.~      Many studies compared the effectiveness of medical treatment compared to surgery in~     management of incomplete abortion. There is only one study compared the curettage with~     expectant management in those women after medical therapy.However; none of them, looked at~     the effectiveness of the second chance of medical treatment in management of incomplete~     abortion in trial to avoid the surgical intervention after failure of previous medical~     treatment. So we think that the immediate evacuation using surgical intervention is truly~     unnecessary in most cases of failed medical abortion and the patients may get benefit from~     another trial of medical treatment.~   "
31974|NCT03148548|"~     Patients with previous diagnosis of iliac vein thrombosis are enrolled in this registry.~     Using standardized questionnaire, clinical data detailing venous thromboembolism and~     contributing VTE risk factors are recorded. Results of technical and laboratory~     investigations including screening of thrombophilic disorders were additionally entered into~     the database.~   "
31975|NCT03148535|"~     The bipolar depression patients of 18-55 years old were recruited. At the time of enrollment,~     the demographic, symptomatic, neuropsychological, neurobiological and genetic data was~     collected. After the completion of the baseline assessment and examination, the patients were~     given lithium carbonate or lithium carbonate combined with SSRI antidepressant treatment.~     Clinical evaluation was performed at 2 and 8 weeks after treatment, including the therapeutic~     efficacy and adverse drug reactions, and monitoring of serum lithium concentration. The~     patients further receive the fMRI scans after treatment for 8 weeks. Through above work, this~     study aimed to provide some guidance for the use of antidepressants in patients with bipolar~     depression.~   "
31976|NCT03148522|"~     Major depressive disorder (MDD) is a high-disabling disease. But its etiology and~     pathogenesis is not clear, and early recognition, diagnosis and treatment still has many~     challenges. Among numerous clinical manifestations of MDD, anhedonia is an important core~     symptom of MDD, especially in patients with melancholic features. Our previous studies and~     studies abroad have shown that MDD patients had functional abnormality in reward circuit. The~     abnormalities of reward-related core areas, such as the prefrontal cortex - nucleus accumbens~     - ventral tegmental area were closely associated with the development of MDD, and is an~     important neural basis of anhedonia. This study would take the reward circuit as mainline to~     carry out the etiology, diagnosis and therapeutic intervention studies of MDD. We would~     collect MDD patients with melancholic features and other populations with reward dysfunction.~     The neuroimaging techniques, stress assessment, genetic testing and drug intervention methods~     would be mainly used in this study. The functional connectivity of reward regions, such as~     the ventral striatum, nucleus accumben, and ventral medial prefrontal cortex, would be~     analyzed to identify the dysfunction of reward circuit of MDD, and its implication for early~     recognition, diagnosis and prediction of treatment efficacy of antidepressants. We would also~     investigate the effect of genetic and environmental factors on reward function of MDD and its~     biological basis. Finally, through modulating the reward circuit activity using animal~     experiments, we would verify and investigate reward dysfunction of MDD and its biological~     mechanisms. The project is expected to provide for new evidence for the establishment of~     reward mechanism - based objective diagnosis and treatment optimization strategy of MDD.~   "
32024|NCT03147885|"~     This phase Ib/II trial is aimed at studying the combination of a drug named Selinexor~     (selective inhibitor of nuclear export) in combination with standard therapy for B cell~     Non-Hodgkin's lymphoma called R-CHOP. The investigators will establish maximum tolerated dose~     of Selinexor in combination with RCHOP and also study the efficacy of this combination for~     therapy of B cell Non-Hodgkin's lymphoma. Giving Selinexor plus chemotherapy may work better~     in treating patients with B cell non-Hodgkin lymphoma.~   "
31977|NCT03148509|"~     This study will recruit depressed patients unresponsive to selective serotonin reuptake~     inhibitor antidepressant treatment, first-degree relatives (parents or siblings) of depressed~     patients, schizophrenia, Parkinson's disease with and without depression, and healthy~     controls. The subjects need to complete the brain positron emission tomography/magnetic~     resonance examination, stress assessment, genetic testing, clinical evaluation and~     neuropsychological tests. Using the data, this study aimed to identify the abnormalities of~     reward circuit of depression and its differences with other diseases, and its abnormalities~     in first-degree relatives of depression. The depressed patients who were ineffective in~     treatment with selective serotonin reuptake inhibitor antidepressants were then given~     combined medication with dopamine receptor-mediated drugs, including dopamine transporter~     inhibitor - bupropion, D2 receptor antagonist - risperidone, or D2 receptor partial agonist -~     aripiprazole, to examine the regulation of dopamine pathway and its relationship with the~     therapeutic effect. Through the above work, we will provide new evidence for integrating the~     biological evidence of dopamine reward pathway into the clinical practice of depression.~   "
31978|NCT03148496|"~     Half of all individuals will undergo abdominal surgery in their lifetime. Following abdominal~     surgery, 30% of patients will suffer a major chronic complication with their wound closure in~     the first post-operative year. This may include significant wound infections, open wounds,~     fluid collections, fascial dehiscence, or incisional hernia. These complications not only~     have a substantial impact on the health care system (cost and chronic disease) and the~     hospital (cost and space), but most importantly have a substantial impact on the patient.~     Major chronic wound complications adversely impact patient quality of life and function.~     Potential methods to reduce major wound complications include utilizing specific suturing~     techniques or reinforcing the incision line. Suturing technique of small-bites (0.5x0.5 cm~     bites) as opposed to large bites (1.0x1.0 cm bites) has been shown to be efficacious in~     European populations with a typical body mass index of 20-25 kg/m2. Tissue reinforcement has~     been shown to decrease rates of major wound complications in small randomized controlled~     trials.~      However, the lack of widespread adoption of these practices may be due to issues of~     generalizability including strict inclusion criteria, careful patient selection, and small~     study size. For example, the generalizability of small bites to an overweight population~     (mean BMI in the United States is 28 kg/m2) as opposed to a normal-weight population are~     unclear. The use of synthetic materials in comorbid patients or complex settings may risk~     major wound complications such as prosthetic infection. Biologic materials have been shown to~     be effective in decreasing major wound complications but in different settings. This study is~     being done to assess the effectiveness of different efficacious strategies to decrease the~     rate of major wound complications following abdominal surgery among high-risk individuals The~     researchers hypothesize:~        1. Among high-risk patients undergoing abdominal surgery, the use of small-bites closure~          as opposed to large-bites closure will increase the proportion of patients who are~          free of major, chronic wound complications at 1-year post-operative.~        2. Among high-risk patients undergoing abdominal surgery, the biologic tissue reinforcement~          of the suture line as opposed to no reinforcement will increase the proportion of~          patients who are free of major, chronic wound complications at 1-year post-operative.~   "
31979|NCT03148483|"~     The improvement of maternal and child health remains a key issue in global health. Production~     and improved accessibility of healthy and nutrient-rich milk-based products could potentially~     tackle health and nutrition inequalities in low-income countries.~      This study will assess the acceptability of a multi-component intervention, including~     provision of calcium/vitamin-D fortified milk and periodontal therapy (PT), for improving~     maternal periodontal health and metabolic and inflammatory profiles. The IMPROVE trial is a~     feasibility randomised controlled trial (RCT) with parallel qualitative process evaluation.~     The target population is low-income, pregnant, Brazilian women, with periodontitis, who have~     not seen a dentist in the last 6 months. A series of focus group discussions and interviews~     with the target population will be conducted to identify key barriers and enablers to~     adoption and implementation of the intervention in prenatal clinics in Rio de Janeiro/Brazil.~     Participants will be allocated to 4 groups: 1) early PT (during pregnancy) plus fortified~     milk; 2) early PT plus plain milk; 3) delayed PT (after delivery) plus fortified milk; 4)~     delayed PT plus plain milk.~      The final results will contribute to the understanding of the significance of calcium and~     vitamin D for short and long-term health and the occurrence of diseases, as well as to inform~     the current global debate on vitamin-D supplementation and fortification policy.~   "
31980|NCT03148470|"~     The purpose of this study is to investigate whether theta burst stimulation (TBS) over the~     left dorsolateral prefrontal cortex (DLPFC) influences language switching and cognitive~     flexibility. The experimental paradigm will assess the impact of inhibitory and excitatory~     prefrontal stimulation by TBS versus sham-TBS over the DLPFC in healthy bilinguals.~   "
31981|NCT03148457|"~     When to start anticoagulation in patients with an acute ischaemic stroke and atrial~     fibrillation (AF) is a relevant unanswered question in clinical practice. Direct oral~     anticoagulants (DOACs) are highly effective for secondary stroke prevention in these~     patients, but DOACs were never initiated <7 days after stroke onset in recent trials. The~     ELAN trial will determine the net benefit of early versus late initiation of DOACs in~     patients with acute ischaemic stroke related to AF.~      The main objective is to estimate the net benefit of early versus late initiation of DOACs in~     patients with acute ischaemic stroke related to AF.~      The secondary objectives are to assess all vascular events and all-cause mortality after~     early initiation of DOACs in patients with acute ischaemic stroke related to AF compared to~     late initiation.~   "
31982|NCT03148444|"~     Background: Infection of cardiac implantable electronic device including wound and pouch~     infection, bacteraemia and endocarditis is a common complication of device insertion. The~     role of antibiotic prophylaxis in prevention of this complication is well established. Most~     centres in Israel currently prescribe antibiotics about 5 days following the procedure as~     well, though clear clinical evidence warranting this practise is lacking. Unnecessary~     antibiotic treatment can lead to adverse events including allergy, undesirable effects of the~     antibiotics, establishment of resistance to antibiotics among bacteria and further infections~     with resistant strains.~      Objective: The investigators hope to either establish evidence warranting use of~     post-procedural antibiotic treatment or refuting it.~      Methods: The investigators intend to recruit about 400 patients a year into both trial group~     and control group. The trial group will be treated with post-procedural antibiotics during 5~     days, while the control group will receive no post-procedural antibiotics. The endpoints of~     the study will include infections related to the implantable device and proposed adverse~     effects of the antibiotics. The t-test will be performed in order to evaluate whether benefit~     exists concerning one of the groups.~   "
31983|NCT03148431|"~     The purposes of this study are to determine:~        -  The safety of the study drug and any side effects that might be associated with it.~        -  How much of the study drug gets into the blood stream and how long it takes the body to~          remove it in healthy participants.~      Participants will be admitted to the Clinical Research Unit (CRU) for 3 overnight stays.~      This study involves a single dose of LY3002815 or placebo given as an injection into the~     vein. This study will last approximately 16 weeks including screening. Additional follow-up~     may be required.~      This study is for research purposes only, and is not intended to treat any medical condition.~   "
31984|NCT03148418|"~     This is an open-label, multicenter, non-randomized extension and long-term observational~     study. Participants receiving atezolizumab monotherapy or atezolizumab combined with other~     agent(s) or comparator agent(s) in a Genentech or Roche-sponsored study (the parent study)~     and who continue to receive study treatment at the time of the parent-study closure are~     eligible for continued treatment in the extension study. Dosing regimen for a given~     participant and indication will be according to the respective parent study protocol. Study~     treatment in the extension study can continue until disease progression or beyond if the~     patient continues to derive clinical benefit as judged by the investigator and if allowed by~     the parent study or local prescribing information until death; withdrawal of study consent;~     unacceptable toxicity; pregnancy; patient non-compliance; or study termination by the~     Sponsor, whichever occurs first.~   "
31985|NCT03148392|"~     The primary objective is to assess any differences in patient quality of life between Cryo~     Balloon ablation and Radiofrequency ablation in the treatment of atrial fibrillation. The~     study will also assess any differences in the amount and duration of pain medication required~     after the ablation.~   "
31986|NCT03148379|"~     To compare economic factors and the rate of adverse events between two types of~     instrumentation used for total knee replacement: Single-use Efficiency Instruments with~     Patient Specific Technique (MyKnee®) Traditional Metal Instruments with Conventional Surgical~     Technique~   "
31987|NCT03148366|"~     Objectives: Eradication of H. pylori infection could reduce the occurence or recurrence of~     gastric cancer and peptic ulcer diseases. However, it was estimated that 15-20% of patients~     would fail from first line standard eradication therapy and need second line rescue therapy.~     About 15-30% of patient would fail from second line therapy. Bismuth quadruple therapy and~     triple therapy containing levofloxacin are currently the recommended rescue therapies in the~     second line and third line treatment. Recently, our pilot study showed that modified~     sequential therapy containing levofloxacin achieved high eradication rate (95%) in the second~     line therapy. The regimen includes a PPI plus amoxicillin for 5-7 days, followed by a PPI~     plus levofloxacin and metronidazole for another 5-7 days. However, whether this modified~     sequential therapy containing levofloxacin is more effective than bismuth quadruple therapy~     in the second line and third line treatment remains unknown. Besides, the impact of these~     regimens on the antibiotic resistance , microbiota of gut flora, and metabolic factors~     remains unknown.~      Aims: Therefore, the investigators aimed to~        1. compare the eradication rates and long term re-infection rates of sequential therapy~          containing levofloxacin for 14 days versus bismuth quadruple therapy for 10 days in the~          second line and third line treatment~        2. assess the impact of antibiotic resistance and CYP2C19 polymorphism on the eradication~          rate of these regimens~        3. assess the impact of these eradication regimens on the antibiotic resistance and~          microbiota of the gut flora~        4. assess the impact of eradication therapy on the metabolic factors~   "
31988|NCT03148353|"~     Subacromial injection is a useful procedure to counteract shoulder impingement syndrome. With~     the aid of high‐resolution ultrasound, the needle can be introduced precisely into the~     subacromial/subdeltoid bursa located between the acromion above and the supraspinatus tendon~     below. The standardized method allows the injectate to distribute along the subdeltoid bursa,~     further reliving pain from subacromial/subdeltoid impingement. In a substantial part of~     shoulder pain patients, it is common to accompany pain along the bicipital groove, which the~     biceps long head tendon courses through. The biceps long head tendon is attached to the~     superior labrum of the glenoid cavity and acts as the second important structure to prevent~     upward migration of the humeral head, following the supraspinatus tendon. Overuse injury of~     the biceps tendon is a likely cause of anterior shoulder pain. Concomitant administration of~     medication into the subacromial bursa and biceps tendon sheath is theoretically more~     effective than injection to the subacromial bursa only because the formal procedure targets~     two vulnerable structures in shoulder impingement syndrome at once. Regarding the standard~     ultrasound‐guided subacromial injection. Therefore, we will conduct a randomized controlled~     trial investigating the effectiveness of standard subacromial injection in comparison with a~     novel approach simultaneously injecting the subacromial bursa and biceps tendon sheath.~   "
31989|NCT03148340|"~     The purpose of this study is to assess the ability of the Fluids Monitor to detect~     hemispheric bioimpedance asymmetry associated with acute brain pathology in patients~     presenting with suspected Acute Ischemic Stroke (AIS).~   "
31990|NCT03148327|"~     This study uses durvalumab (MEDI 4736), an experimental type of drug made by Astra Zeneca~     Pharmaceuticals, (limited partnership) LP, which in early studies has shown to possibly~     reduce the growth of certain types of lung cancer. The Investigators will enroll up to 105~     subjects into the study. After an initial safety sample of 15 individuals receiving~     durvalumab (MEDI 4736) and Stereotactic Ablative Body Radiotherapy (SABR), if it is shown to~     be safe to administer this combination of therapies, the next enrolled subjects will be~     randomized in a 1:1 fashion (each subject with a 50-50 chance like the flip of a coin) to~     receive either SABR and durvalumab (MEDI 4736), or SABR alone.~      Once treatment is completed, all subjects will return to the University of California at Los~     Angeles (UCLA) for regular follow-up visits to check on their health and outcomes. At visits~     both prior to and after treatment special blood samples will be drawn to be studied by UCLA~     scientists to look into the basic science aspects of how durvalumab (MEDI 4736) and radiation~     work in the body. It is hoped that we will learn more about the basic safety and science of~     durvalumab (MEDI 4736) combined with Stereotactic Ablative Body Radiotherapy (SABR) vs. SABR~     alone, while extending the life and quality of life of these subjects.~   "
31991|NCT03148314|"~     The world health organization defined abortion or miscarriage as : the expulsion or~     extraction from its mother of a fetus or an embryo weighting 500 grams or less ,or any other~     wise product of gestation of any weight irrespective of gestational age and weather or not~     there is evidence of life and weather or not the abortion was spontaneous or induced~     Miscarriage is the most common complication of pregnancy occurring in 10-20% of clinically~     recognized pregnancies (Bag. It is estimated that around 40% of early pregnancies result in~     miscarriage. A large majority of those are lost before the menstrual period is missed. More~     than 80%of abortions occur in first 12 weeks of pregnancy, and the rate decrease there after~     For clinical purposes: abortion is subdivided into: threatened abortion, inevitable abortion,~     incomplete abortion ,missed abortion ,septic abortion ,and recurrent abortion~   "
31993|NCT03148288|"~     Irritable bowel syndrome (IBS) is a very common functional gastrointestinal disorder~     affecting nearly 20% of the North American population. IBS is characterized by chronic~     abdominal, associated with a change in bowel frequency and or consistency that lack a known~     structural or anatomic explanation. Current treatment for IBS is primarily symptom-based.~     However over a third of patients with IBS fail to respond to currently available therapies.~      The prevalence of vitamin D deficiency/insufficiency is estimated in over a billion people~     world-wide . Vitamin D has potential mechanisms not only in the balance of calcium and bone~     homeostasis, but also a key modulator of the immune system. Vitamin D receptors (VDRs) are~     located on all nucleated cells including the GI tract. Thus far, there is already~     accumulating evidence for a role for vitamin D supplementation in inflammatory bowel disease~     (IBD). A recent systematic review suggested there may be benefits of vitamin D~     supplementation in IBD.~      Vitamin D insufficiency is widespread in patients with IBS and there is a positive~     association between vitamin D status and quality of life. To date, there is no US trial~     examining the effect of vitamin d supplementation on IBS symptoms and quality of life in~     patients with IBS.~   "
31994|NCT03148275|"~     This phase II trial studies how well trametinib works in treating patients with epithelioid~     hemangioendothelioma that has spread to other places in the body, nearby tissue or lymph~     nodes, or cannot be removed by surgery. Trametinib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth.~   "
31995|NCT03148262|"~     It is standard practice in the United States and many parts of world to perform~     Gastrointestinal (GI) endoscopy with the patient under deep sedation. Obesity is accepted as~     a patient specific risk factor for hypoxic events during procedural sedation for GI~     endoscopic procedures. The Obese population has a higher prevalence of obstructive sleep~     apnea (OSA) which is characterized by repeated obstruction of the upper airway, and leads to~     apnea and desaturation. This prospective, randomized study was designed to compare the~     effectiveness of the high flow nasal cannula and the standard nasal cannula in morbidly obese~     (BMI > 40) patients receiving deep intravenous sedation during colonoscopies. This study will~     assess whether use of the high flow nasal cannula (HFNC) leads to less intraoperative~     desaturation events compared to the current standard of care.~   "
31996|NCT03148249|"~     Charles Bonnet Syndrome (CBS) is defined by the occurence of visual hallucinations (VH) in~     the absence of any mental disorder. Elderly patients with reduced visual acuity due to~     ophthalmic diseases are most affected. Conditions are often associated with the syndrome of~     age-related macular degeneration, cataract or glaucoma. Existing data on the syndrome's~     prevalence in Europe reveal diverse results. Aim of this study was to assess the prevalence~     of CBS in patients with low visual acuity and to evaluate, if an additional therapeutic~     interview with and treatment by a psychiatrist is beneficial.~   "
31997|NCT03148236|"~     Single-center, double-blinded, randomized, controlled safety and feasibility pilot study of~     high dose IV ascorbic acid (200mg/kg) over 24 hours, divided into four doses and administered~     every six hours with a 30 minute IV infusion time per dose, compared to matched placebo~     infusion~   "
31998|NCT03148223|"~     This study aims to determine if auriculotherapy is effective in the treatment of~     dysmenorrhoea. This intervention consists of fixation of yellow mustard seeds at specific~     points of the auricular pavilion (or area), with opaque tape. Half of the participants will~     have specific ear pinch points stimulated by mustard seeds fixed with opaque plaster, while~     the other half will have only the adhesive plasters fixed, without the seeds for stimulation.~   "
31999|NCT03148210|"~     Previous population health studies suggest that up to 10% of Canadian adults have undiagnosed~     asthma or COPD- these people are currently undiagnosed and untreated, even though they may~     have significant respiratory symptoms. Our study will use targeted casefinding to find people~     with undiagnosed asthma and COPD in Canadian communities. The investigators will assess their~     symptoms and their health care use and number of sick days to determine the burden of~     undiagnosed respiratory disease in these people. The investigators will then determine~     whether early treatment of previously undiagnosed airflow obstruction will improve patients'~     health outcomes.~   "
32000|NCT03148197|"~     COLLECT is a monocentric, prospective, observational study, which aims to assess the~     association between changes in the intestinal microbiota and the incidence of~     gastrointestinal graft-versus-host diseases (GvHD). Patients admitted for performance of an~     allogeneic hematopoietic stem cell transplantation (HSCT) or patients with a first diagnosis~     of an acute myeloid leukemia (AML) will be enrolled and stool samples will be analyzed using~     next-generation sequencing. In addition to stool, blood and urine samples will be collected~     for cytokine and 3-indoxylsulfate analysis.~      Exposure to drugs will not be influenced and remains at the discretion of the treating~     physician.~   "
32001|NCT03148184|"~     The purpose of this study is to assess the early outcomes following Reverse Shoulder~     Arthroplasty (RSA) in patients sixty years or younger for the purpose of characterizing these~     patients, evaluating their clinical outcomes and radiographic appearance.We would like to~     know how quickly they are healing and returning to their baseline activities of daily living~     and ability to work. This will help when counseling patients prior to surgery as it will give~     us a better defined and study supported understanding of the post-operative recovery timeline~     in the younger population.~   "
32002|NCT03148171|"~     The Project PrEP-R intervention is a brief, theory based and culturally sensitive~     intervention designed to capitalize on organic yet underutilized social support networks in~     the lives of young black men who have sex with men (YBMSM). The intervention has been~     developed with input from clients and their support network members, case managers, social~     workers, primary care providers. The goal of the intervention is to improve retention in PrEP~     care for young Black MSM.~   "
32003|NCT03148158|"~     This will be a prospective trial comparing the perspective gross morphological of bladder~     tumor assessment done by outpatient flexible cystoscopy performed by resident, inpatient~     rigid cystoscopy done by senior staff and their prediction of the degree of invasion of~     bladder tumor plus the prediction of the grade compared with the standard pathological~     result.~      Also, assessment of the patient reported outcomes after both flexible and rigid cystoscopy~     will be done.~      In the long run of the study, the prognostic gross morphology with recurrence, progression~     and cancer specific survival will be assessed.~   "
32004|NCT03148145|"~     The overall goal of this study is to test personalized mobile phone-based physical activity~     interventions among students at the University of California, Berkeley. Most physical fitness~     applications for smartphones and activity trackers use a constant goal for the number of~     steps each day. However, if the step goals are dynamically adjusted according to past~     behavior, then the corresponding goals may encourage individuals to increase their physical~     activity level. This study consists of a randomized controlled trial in which we are~     assessing the efficacy of four different algorithms for calculating personalized goals for~     the number of steps each day and for determining which motivational messages to send each~     day.~   "
32005|NCT03148132|"~     The Retinopathy of Prematurity (ROP) is one of the leading causes of blindness on the~     pediatric age worldwide. This pathology is characterized for arrest of the normal vascular~     and neuronal retina that because of pathological compensatory mechanisms results in~     proliferation of vascular tissue that grow in the limit between the vascular retina and the~     avascular retina.~      The ET-ROP group classified the ROP by those who need treatment immediately or those who~     doesn't need treatment, The classification is the following Type 1 ROP-->ROP zone I any stage~     with plus, zone I stage 3 without plus, zone II stage 2 y 3 with plus Type 2 ROP --> Zone 1,~     Stage 2 or 3 without plus, and Zone II, stage 3 without plus.~      The treatment is begun on patient with type 1 ROP and type 2 ROP is maintained in~     observation.~   "
32006|NCT03148119|"~     A Phase 1B study of the efficacy of a topically-administered 7-amino acid peptide labeled~     with a near-infrared fluorophore Cy5 for detecting neoplastic areas of the colon is proposed.~     The study will test the efficacy of administering this agent (QRH-882260 Heptapeptide) to~     human subjects undergoing clinically-indicated colonoscopy for endoscopic resection of known~     colonic adenomas or for surveillance biopsies of known dysplasia in the setting of irritable~     bowel disease (IBD). Up to 120 evaluable subjects will be enrolled.~      Subjects will be recruited around scheduled standard of care procedures. The endoscopists~     performing the procedures are all endoscopists credentialed at the University of Michigan to~     do these procedures. Urine for dipstick pregnancy testing (if applicable) will be collected~     before the procedure, along with medical information. Vital signs are routinely monitored~     throughout the clinical procedure and are available in the electronic medical record. The~     endoscopy will proceed per the University of Michigan Health System (UMHS) standard of care.~     The endoscopist performing the clinical procedure will evaluate the potential risk (if any)~     for the subject to continue with the procedure or study. Five mL of the reconstituted~     QRH-882260 Heptapeptide (~100 μM) will be sprayed onto the site of interest through a~     catheter in the endoscope. Five minutes after QRH-882260 Heptapeptide application, the~     unbound peptide will be washed off using the endogator irrigator and the residual liquid will~     be suctioned. Pictures with white-light and fluorescence will be taken with the scanning~     fiber based molecular imaging endoscopic probe inserted via the instrument channel of the~     standard endoscope before the QRH-882260 Heptapeptide application, immediately after~     application and then again after the QRH-882260 Heptapeptide will be washed off. The area of~     interest identified will be resected/biopsied per discretion of the endoscopist per clinical~     care. All specimens taken are for clinical care only (not research use) and will be sent for~     routine histology per UMHS standard of care.~   "
32007|NCT03148106|"~     The purpose of this study is to find out what are the best settings for applying electrical~     nerve stimulation over the skin for the short-term improvement of hand dysfunction after a~     stroke. The ultimate goal is to some day design an effective long-term training program to~     help someone recovery their ability to use their hands and function independently at home and~     in society. In order to know how to apply electrical nerve stimulation to produce a good~     long-term effect on hand dysfunction, we first need to know how to make it work best in the~     short-term, and improve our understanding of for whom it works and how it works.We will use a~     commercially available transcutaneous electrical nerve stimulation (TENS) unit to gently~     apply electrical nerve stimulation over the skin of the affected arm. This is a portable,~     safe and easy to use device designed for patients to operate in their homes.~   "
32008|NCT03148093|"~     The CHOICE Registry will describe real-world treatment patterns and physician and patient~     (and caregiver)-reported outcomes associated with patients who have progressed beyond 2nd~     line metastatic colorectal cancer.~   "
32009|NCT03148080|"~     To document levels of labor force participation, occupation, educational attainment, and~     financial toxicity following cancer treatment in YA cancer survivors aged 25-34 years.~   "
32010|NCT03148067|"~     Diaphyseal femoral and tibial fractures are in the spotlight within the~     traumatology-orthopedics scenario. Intramedullary nailing (IMN) remains the method of choice~     for treating these fractures, both open and closed ones. Occurrences of surgical site~     infection (SSI) related to this type of osteosynthesis are a challenge for all the~     professionals involved in patient healthcare. The reported incidence of SSI after IMN ranges~     from 0.9 to 17.5%. The majority of the data comes from retrospective studies and as part of~     case series descriptions, with little detail about the criteria used for defining and~     searching for cases of infection. Regarding the potential risk factors for this complication,~     previous use of external fixators, occurrence of open fractures and the severity of exposure~     according to the Gustilo-Anderson classification were indicated in a few retrospective~     studies as being possibly related to this complication. The objectives of the present~     observational cohort study are: 1. To determine the incidence of SSI related to IMN for~     fixation of diaphyseal femoral and tibial fractures in patients treated in a university~     traumatology and orthopedics reference hospital in São Paulo, Brazil; 2. To evaluate the risk~     factors related to the occurrence of this type of infection.~   "
32011|NCT03148054|"~     Patients undergoing elective surgery for left-sided colon resection are asked to participate~     in this study: Every patient undergoes two types of examinations (endoscopy, CT scan) on day~     3, 4 or 5 postoperatively. These two procedures are subject to investigation in terms of~     their accuracy (sensitivity, specificity) in detection of anastomotic leaks. The patients are~     followed up until day 42 postoperatively. There are no other specific tests or examinations~     within the study. Information and informed consent are obtained preoperatively.~   "
32012|NCT03148041|"~     The investigator of this study would like to test the hypothesis of the effectiveness of~     health education program on level of awareness of stroke among population at risk whom~     attending the primary health care center in Jeddah, in Saudi Arabia. The investigator will~     divide the participants into two groups. The intervention group whom will have the intensive~     health education program, and the control group whom will have the routine care. Participants~     will be followed up for 3 months to assess the effect of different health education programs~     on their level of awareness about stroke. Also The investigator will relate different~     socioeconomic factors to level of awareness.~   "
32013|NCT03148028|"~     The investigators wish to characterize alterations in the architecture and function of immune~     cells in patients with a primary immunodeficiency that also develop inflammatory bowel~     disease. In addition, The investigators' goal is to characterize the microbiome of these~     patients, in order to determine whether specific microbial alterations are related to~     inflammation.~   "
32014|NCT03148015|"~     This project is an immunohistochemical study of archived patient breast tissue, specifically~     pre-invasive lesion specimens. The purpose is the discovery of novel molecular markers of~     pre-invasive breast lesions. These novel markers, once validated in this study, can serve as~     targets for individualized prevention therapy, neoadjuvant therapy for ductal carcinoma in~     situ (DCIS), or predictors of lesion aggressiveness. We have discovered two novel classes of~     DCIS molecular pathways required for the survival of DCIS neoplastic cells that will serve as~     the basis for the candidate molecules to be evaluated in this proposed study. The first class~     of DCIS molecular markers is autophagy, a cell survival mechanism that we discovered to be~     highly augmented in the hypoxic and nutrient deprived intraductal neoplastic cells of human~     DCIS (1-4). The second class of biomarker is calcium efflux that is mediated in breast cells~     by the calcium export pump Plasma Membrane Calcium ATPase (PMCA2) (5, 6). During normal~     lactation, breast epithelium pumps large concentrations of calcium into milk. In neoplastic~     lesions, calcium is exported by PMCA2 as a cell survival mechanism, since cells under~     metabolic stress accumulate calcium to a toxic level. Calcium export in DCIS may also~     contribute to intraductal calcifications, a hallmark of high grade DCIS and the most common~     marker of DCIS on mammography (7).~      Sentara cares for hundreds of patients per year who are diagnosed with breast pre-invasive~     lesions, including atypical ductal hyperplasia (ADH), ductal carcinoma in situ (DCIS), and~     lobular carcinoma in situ (LCIS). Sentara treats 25% of the women with breast cancer in~     Virginia. Coupled with information from the Sentara Cancer Registry, Dr. Hoefer or a research~     team member will identify eligible patients with ADH, DCIS, and/or LCIS at the time of the~     core biopsy diagnosis, surgical therapy, and/or upon lesion recurrence. After receiving~     written informed consent from the eligible patients, Sentara Pathology will retrieve the~     corresponding tissue blocks. The recut tissue sections will be processed at George Mason~     University, Center for Applied Proteomics and Molecular Medicine for markers relevant to~     calcium signaling, Vitamin D response, proliferation, autophagy and inflammation. Combined~     with the translational research expertise/technology in the Center for Applied Proteomics and~     Molecular Medicine at George Mason University, Sentara's diverse patient cohort provides an~     opportunity to address the most fundamental unanswered questions surrounding the etiology,~     progression, and therapy of pre-invasive breast lesions.~   "
32015|NCT03148002|"~     Constipation is a common condition, which occurs one in four Canadians. Maintaining regular~     bowel movements is imperative because constipation can affect the quality of PD dialysate~     flow and result in an unwanted effect on the dialysis adequacy.~      There is limited data on how to best manage constipation in the peritoneal dialysis~     population. Polyethylene glycol (PEG) is an osmotic laxative that is becoming popular for~     prevention and treatment of constipation across Canada. Although some PD programs in Canada~     have already converted to PEG for management of constipation, more research in this~     population would help guide practice. For now, the current PD bowel regimen at the Nova~     Scotia Health Authority (NSHA) includes daily preventative therapy using a stimulant~     laxative, senna, along with an osmotic laxative, lactulose, for acute constipation.~      The investigators will review all patients in the NSHA PD program who have regular or recent~     laxative use for participation in this study. Patients included in this study will be~     randomly assigned to the Current Bowel Protocol or the PEG Bowel Protocol for 8 weeks.~      The goal is to determine if the PEG Bowel Protocol is as effective and safe for the~     prevention of constipation as the Current Bowel Protocol used in the PD Program. The~     investigators will use bowel function diaries and patient surveys to determine efficacy and~     safety outcomes.~   "
32016|NCT03147989|"~     This is a retrospective study to collect already existing data and images from patients ≥ 2~     years of age who had MRI for CNS diseases with MultiHance administration at a standard 0.10~     mmol/kg dose or the half dose of 0.05 mmol/kg. The MRI images of all included patients will~     be prospectively reviewed in a blinded read to compare the efficacy of the two doses.~   "
32017|NCT03147976|"~     This is a phase 2 study of AMG 337 in subjects with advanced or metastatic solid tumors that~     overexpress MET or harbor METex14del mutations resulting in MET exon 14 skipping.~   "
32018|NCT03147963|"~     A Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety of a Single Agent~     Docetaxel 2-Weeks Regimen in the Treatment of HER2 Negative Metastatic Breast Cancer to a~     3-Weeks Regimen~   "
32019|NCT03147950|"~     compare the prone with the prone-flexed position accessibility of upper and middle calyceal~     approach by subcostal puncture and PCNL reporting complications using the Clavien-Dindo~     system with Categorisation of PCNL-specific complications according to Clavien-Dindo~     classification score~   "
32020|NCT03147937|"~     Patients assume that cognitive performance rapidly returns to baseline after anesthesia and~     surgery. Several studies have shown that one week after major non-cardiac surgery about 27%~     of patients have postoperative cognitive dysfunction (POCD) and 10% of patients at 3 months.~     Very few studies have assessed the incidence of POCD beyond 3 months. POCD significantly~     reduces quality of life. Identifying risk factors for POCD is important because it is~     associated with prolonged hospital stay, loss of independence, and premature retirement.~     There is an urgent need to measure and document the level of cognitive change associated with~     surgery with an easy to use tool, both prior to admission and after discharge. This~     information can be used to plan appropriate care paths and to identify or test the efficacy~     of potential new treatments to alter the negative trajectory.~   "
32021|NCT03147924|"~     This study is taking place to examine the preliminary effects of improvisational therapy~     (improv group) on social anxiety for youth at the Youth Wellness Centre (YWC). The improv~     group will run for 12-weeks as a drop-in group. A typical session will begin with stretching,~     simple breathing and an activity to promote group cohesion. Following this, improvisation~     games and activities will be introduced with the goal of promoting the following skills:~     assertiveness, acceptance, problem solving, co-operate skills, non-verbal communication,~     mindfulness, and memory. Youth who consent to the study will be asked to complete a set of~     brief questionnaires the first time they attend one of the sessions. Youth who have attended~     at least 3 sessions will be asked again to complete questionnaires following the completion~     of week 12 session. Youth will also rate their anxiety and distress on a simple rating scale~     at the beginning and end of each session. Additionally, all participants (who have attended~     three or more sessions) will be invited to complete a 30 to 45 minute qualitative interview~     following the 12 week session. Participants are predicted to show a decrease in social~     anxiety, generalized anxiety and depression symptoms, and an increase in self-esteem, and~     perceived social support.~   "
32022|NCT03147911|"~     The purposes of this study are to assess the prevalence of patients with a low risk of stroke~     or systemic embolism based on a CHA2DS2-VASc score among patients who have an AF-related~     thromboembolism and to identify the clinical and laboratory risk factors associated with~     thromboembolism in AF patients with a CHA2DS2-VA score of 0 or 1.~   "
32023|NCT03147898|"~     This is an observational study designed to describe the immune profile of toddlers and~     preschoolers with acellular priming after receiving a booster dose of pertussis vaccine.~   "
45442|NCT02972047|"~     This study aims to understand why patients have predominantly upright gastroesophageal reflux~     disease by comparing such patients to healthy persons AND whether a behavioral intervention~     (diaphragmatic breathing) will impact this disease~   "
32025|NCT03147872|"~     Clinical in vitro fertilization relies on successful embryo culture. The primary goal of~     embryo culture is to attempt to recapitulate the in vivo conditions as much as possible. In~     the past decade, the majority embryo culture has been performed at 5% oxygen due to the~     discovery that the oxygen tension in the fallopian tube (where the embryo is located for the~     first 3 days after fertilization) is 5%. However, relatively recent studies have demonstrated~     that the oxygen tension in the uterus (where the embryo is located after day 3) is closer to~     2%. This study is a randomized controlled trial that will compare pregnancy rates between~     embryos cultured in 2% versus 5% after day 3 of development.~   "
32026|NCT03147859|"~     Background:~      In nearly all people with human immunodeficiency virus (HIV) infection, immunity cannot~     either control or eradicate the infection. There are good medicinal treatments, collectively~     called ART (antiretroviral therapy) which control HIV infection by suppressing the virus in~     the bloodstream. ART is needed for life, and if a person stops taking ART the HIV infection~     returns in the bloodstream. So, there is good treatment, but no cure. The researchers want to~     test whether a period of treatment with vedolizumab can be used to control HIV infection in~     the bloodstream in persons with HIV on ART, after stopping ART.~      Objective:~      To determine whether vedolizumab is safe and tolerable in people with HIV, to assess the~     safety of an analytical treatment interruption (ATI), and to determine whether vedolizumab~     can control HIV infection in the bloodstream without the use of ART.~      Eligibility:~      Adults 18-65 with HIV who are being treated with ART~      Design:~      Participants will be screened with: Physical exam, medical history, blood and urine tests~     Participants will have a baseline visit which will include repeat of the screening testing.~      Participants will then present for their first study visit which will include: receiving~     vedolizumab infusions through an arm vein, repeats of the baseline testing. Participants will~     then have serial visits on a pre-specific schedule to receive ongoing vedolizumab doses every~     2-4 weeks until week 20. Each visit will also include repeat of the baseline tests.~      After week 6 and before week 7 patients will discontinue ART. After the final infusion of~     vedolizumab at week 20 patients will continue to be assessed with physical exam, medical~     history, and repeat of the baseline testing every 4 weeks up to 1 year.~      ART will be re-started for participants if the level of HIV in the blood becomes too high,~     persists for too long, or if the CD4 count decreases by too much.~   "
32027|NCT03147846|"~     Comparing the beneficial effect of cord milking versus deferred cord clamping in preterm~     neonates. A randomized controlled trial~   "
32028|NCT03147833|"~     32 runners will be randomized into two groups. The duration of the intervention is one week~     including a strenuous endurance training program. Group 1 receive a protein beverage before~     each night sleep and Group 2 receive an isocaloric carbohydrate beverage. Performance test~     before and after the intervention and blood sampling before and during the intervention to~     check for markers for muscle damage.~   "
32029|NCT03147807|"~     The emergence and rapid worldwide spread of Extended- Spectrum Beta-Lactamase-producing~     enterobacteriaceae (ESBLE) both in hospital and community, led physicians, and notably~     intensivists, to prescribe more carbapenems, particularly in the most fragile patients such~     as ICU patients. Unfortunately, the increased carbapenem consumption favored the emergence of~     carbapenem resistance mechanisms. Moreover, several preliminary results suggest that~     carbapenem could markedly impact the human intestinal microbiota, Thus, reduction of~     carbapenem exposure is widely desired both by national and international antibiotic plans.~     Therefore, the use of rapid diagnostic tests evaluating bacterial resistance to reduce~     inappropriate exposure to carbapenems could be a relevant solution. Due to its good~     diagnostic performance, the betaLACTA® test could meet these objectives.~      Experimental plan :~      Randomized, open-labeled non-inferiority clinical trial involving an in vitro diagnostic~     medical device (close to a phase III study), comparing two parallel groups:~        -  Experimental group: early carbapenems de-escalation since the second dose, guided by~          results of the betaLACTA® test performed directly on the bacterial pellet from the~          microbiological sample positive on direct examination.~        -  Control group: carbapenems de-escalation guided by definitive results of the antibiotic~          susceptibility test obtained 48 to 72h after microbiological sampling (reference~          strategy).~   "
32030|NCT03147794|"~     A new technology system called MyndMove has been developed by MyndTec Inc. (Missisauga~     Canada) to administer FES. The purpose of this technology is to improve voluntary upper limb~     (hand and arm) function (i.e. reaching and grasping) for patients with hemiparesis as a~     results of stroke or spinal cord injury (7). It is a non-invasive application that delivers~     electrical stimulation to the affected limb transcutaneously. MyndMove has been licensed by~     Health Canada and is indicated as a functional electrical stimulator for improvement of arm~     and hand function and active range of motion in patients with hemiplegia due to stroke or~     upper limb paralysis due to C3-C7 spinal cord injury. In a randomized controlled trial~     looking at adults with acute stroke and limited or complete immobility of the arm, FES and~     intensive therapy was shown to have significant improvement of hand function compared to the~     control group that was exposed to intensive therapy only (8). Limited research using MyndMove~     to administer FES has been conducted for pediatric populations, however there is significant~     potential for FES and intensive therapy to improve hand function for children with upper~     extremity hemiparesis using MyndMove technology. Before the efficacy of MyndMove therapy can~     be evaluated in children age 3 to 6, the tolerability of the system must first be evaluated~     and proven for this age group.~   "
32031|NCT03147781|"~     The aim of this study is to function as a pilot study in evaluating the effects of auricular~     therapy (AT) on lactation for women in the immediate post cesarean period while examining the~     feasibility of the three-parallel-arm, sham-controlled randomized design. The study~     hypothesizes that post cesarean women who receive AT with standard care for 96 hours~     postpartum have earlier onset of lactogenesis II and larger milk production when compared~     with women who receive sham AT with standard care or standard care alone.~   "
32032|NCT03147768|"~     The laser tissue welding device is intended for use in patients requiring sealing of the~     pancreas after partial pancreatectomy, and including those patients who are fully heparinized~     or have hemodilutional coagulation failure.~      The hypothesis is that the laser tissue welding device is safe and effective in sealing the~     pancreas, thereby decreasing the blood loss (operative and post-operative), and pancreatic~     juice leakage for patients when the Laser Tissue Welding device is used after pancreatic~     resection.~   "
32033|NCT03147755|"~     Oropharyngeal dysphagia (OD) is a common morbidity after stroke that disrupts swallowing~     physiology. The investigators aimed at evaluating the prevalence of oropharyngeal dysphagia~     (OD) after stroke and analysing the risk factors and associated complications.~   "
32034|NCT03147742|"~     To provide ruxolitinib through an expanded access program for the treatment of~     graft-versus-host disease (GVHD) in United States to patients who are ineligible or unable to~     participate in any actively enrolling Incyte-sponsored clinical studies for ruxolitinib in~     the treatment of GVHD.~   "
32035|NCT03147729|"~     Anal incontinence (AI) is used to englobe the involuntary loss of both fecal material and~     gases, which can help to improve quality of life. Based on these experiences objectives were~     drawn: to evaluate the effectiveness of radiofrequency and it's influence on quality of life~     of patients with anal incontinence, to correlate the anal incontinence severity and to~     evaluate a sexual function and to verify an influence with radiofrequency treatment. It is a~     blind randomized clinical trial. For the collection of data it was used a fecal quality of~     life questionnaire (FIQL). The questionnaire assess the severity of Anal Incontinence (FISI),~     the degree of patient's satisfaction using a five-point scale (Likert) and a visual analogue~     EVA scale). It was divided in two groups, in one group it was used radiofrequency and pelvic~     exercises and in the other turned off radiofrequency (heated glycerin) and pelvic exercises.~     It was accomplished in eight sections. As a result, it is expected the efficiency of the~     treatment of radiofrequency in the quality of life, in sexual function and in it's severity.~   "
32036|NCT03147716|"~     This study tests the effectiveness of different strategies for engaging parents into an~     evidence-based parenting skills intervention, the Triple P Positive Parenting Program,~     offered universally to parents of children attending one of six public elementary schools.~   "
32037|NCT03147703|"~     The purpose of this investigation is to test the hypothesis that in humans, eating late may~     induce changes in saliva microbiota daily rhythms towards a more obesogenic and a less~     responsiveness to dietary treatments profile. These changes in microbiota may partly explain~     the weight loss difficulties that characterized late eaters in previous studies. Thus, the~     aim is to analyze the effect of the timing of food intake in humans' saliva microbiome daily~     rhythms in a randomized, crossover interventional study, in order to achieve.~   "
32038|NCT03147690|"~     This study proposes to evaluate the accuracy of contrast-enhanced ultrasound (CEUS) in~     diagnosing abdominal solid organ injuries in pediatric patients. 146 subjects will be~     enrolled across approximately 8 sites in the US. All subjects will have had a Computerized~     Tomography (CT) scan as part of standard of care, confirming at least one solid organ~     abdominal injury. All subjects will have an abdominal ultrasound without contrast, followed~     by a contrast-enhanced ultrasound using the contrast agent Lumason. Ultrasound and~     contrast-enhanced ultrasound results will be compared to the CT scan results. The study~     procedures will take place within 48 hours of injury.~   "
32039|NCT03147677|"~     This is a prospective, multi-center, randomized, open-label, parallel-arm controlled study,~     for which a total of 216 patients with type 2 diabetic nephropathy (Stage II-IV) will be~     enrolled. The subjects will be randomized to three groups in 1:1:1 ratio. One group receive~     Alfacalcidol 0.25ug/day and Irbesartan 150mg/day for 16 consecutive weeks. The second group~     receive Alfacalcidol 0.25ug/day alone for 16 consecutive weeks. The third group receive~     Irbesartan 150mg/day alone for 16 consecutive weeks. All subjects will be followed up for 4~     weeks after medication is over. A total of 4 visits have been scheduled for this study at~     week 0, week 8, week 16, week 20.~   "
32040|NCT03147664|"~     Introduction: Enzyme replacement therapy (ERT) with Myozyme improved the prospect of Pompe~     disease patients. Our aim was to evaluate ERT acute effect on exercise capacity in pediatric~     Pompe patients.~      Methods: Pompe patients (10-19 years) were evaluated before and two days after ERT using~     cardiopulmonary exercise testing (CPET), six minutes walking test (6MWT) and motor function~     test (GMFM-88).~   "
32041|NCT03147651|"~     Introduction: Bronchiectasis is a chronic lung disease in which the underlying condition~     causes permanent damage to the conducting airways. Bronchiectasis is associated with~     considerable morbidity and poor quality of life. While cystic fibrosis (CF) is the most~     common cause of bronchiectasis in childhood, non-CF bronchiectasis is associated with a wide~     variety of disorders. CF bronchiectasis patients show reduced daily habitual physical~     activity and exercise capacity. Cardiopulmonary exercise test (CPET) is increasingly gaining~     importance in clinical medicine and considered the gold standard exercise test for assessing~     aerobic exercise capacity. The test objectively evaluates exercise physiological functions,~     may help assess morbidity and predict the outcome and mortality in different clinical~     circumstances and may serve as a basis for individualized exercise prescription within the~     limitation of the disease. Unlike CPET in CF, there is a paucity of data on exercise capacity~     using CPET in non- CF bronchiectasis patients, and on the implications of physical activity~     on non- CF bronchiectasis morbidity and mortality.~      Aim: To evaluate and compare exercise capacity in CF and non-CF bronchiectasis patients.~      Methods: This will be a cross-sectional retrospective/prospective study population. The~     retrospective study will include data analysis of patients that preformed CPET as part of~     their clinical evaluation. In the prospective study, patients that are scheduled to perform~     CPET as part of their clinical evaluation will sign (or legal guardian) informed consent~     prior to participation. Patients will be recruited from the exercise clinic at the Pediatric~     Pulmonary Institute at the Rappaport Children's Hospital. Inclusion criteria: 1. Children and~     adults (age >7 years, height >125cm), with CF and non CF bronchiectasis. 2. Completed a~     maximal CPET test according to accepted criteria; (maximal VO2 > 80% predicted, maximal heart~     rate > 80% predicted, acceptable RER (RER > 1.0 in children (under 18 years), RER > 1.05 for~     adults) or reaching a VO2 plateau..3. Evidence of bronchiectasis in computed tomography (CT).~      Exclusions criteria: preforming submaximal CPET, lack of data from the exercise test,~     exacerbation of patient's condition within three days before the exercise evaluation,~     relevant related chronic diseases that affecting test results.~   "
32042|NCT03147638|"~     Multi-Center Single Arm Trial to Determine The Effectiveness of Warfarin Therapy Duration For~     Heparin-Induced Thrombocytopenia (HIT)~   "
32043|NCT03147625|"~     Elderly residing in elderly-only households are more vulnerable as they are socially~     isolated, suffer from poorer health outcomes, and are less likely to adopt health-promoting~     behaviors. While multi-dimensional preventive home visits provide older adults with the~     individualized care to cope with living in their homes, group-based education promotes peer~     learning and allows for social interaction. Elderly residing in elderly-only households can~     reap the benefits derived from the coaction of preventive home visits and group-based~     education, providing them with the personalized care to age healthily in their homes and a~     platform to develop social connectedness with their peers. This study uses the combination of~     preventive home visit and group-based education program to promote healthy aging in elderly~     living in elderly-only households.~      Using a randomized controlled trial, the study aims to evaluate the effectiveness of a~     12-week health promotion and risk prevention program, named Salutogenic Healthy Aging Program~     Embracement (SHAPE) for elderly-only households. Participants in the experimental group will~     receive 2 home visits, 10-weekly group-based activity sessions and a SHAPE health-promotion~     booklet. A process evaluation using face-to-face interviews will also be conducted for~     elderly receiving SHAPE to explore their views on the program.~      The use of salutogenic model breaks away from the negatively connoted conventional biomedical~     model and addresses on optimization of positive health. Ultimately, the SHAPE intervention~     seeks to identify, equip and strengthen resources for elderly-only households, encouraging~     the adaption of health-promoting and risk-preventing actions to achieve better health~     outcomes and higher quality of life.~   "
32044|NCT03147612|"~     The goal of this clinical research study is to learn how well ponatinib combined with~     low-intensity chemotherapy may control Philadelphia chromosome-positive (Ph+) or BCR-ABL~     positive acute lymphoblastic leukemia (ALL) in patients who are at least 60 years old.~      In elderly patients with ALL, intensive chemotherapy is effective but causes a lot of side~     effects, some of which are very serious and can be life-threatening. Researchers want to~     learn if using low-intensity chemotherapy in this study can achieve the same effect as~     high-intensity chemotherapy in the long run but with fewer side effects.~      Ph+ and BCR-ABL positive are types of genetic mutations (changes).~      The safety and effectiveness of the study drug combined with low-intensity chemotherapy will~     also be studied.~      Ponatinib may cause a blood clot to form in an artery or in a vein. Depending on the location~     of the clot, this could cause a heart attack, a stroke, severe damage to other tissue, or~     death. A blood clot may occur within 2 weeks after you start taking the drug. About 41%~     (about 2 in 5) of patients taking the drug form an abnormal clot. Blood clots can occur in~     patients that do not have other known risk factors for forming clots. If you develop a blood~     clot, you will need to stop taking ponatinib. In some cases, emergency surgery could be~     needed to remove the clot and restore blood flow.~      This is an investigational study. Ponatinib is FDA approved and commercially available for~     the treatment of Ph+ ALL for whom no other tyrosine kinase inhibitor (TKI) therapy is~     allowed. The chemotherapy used in this study is FDA approved and commercially available for~     the treatment of ALL. It is considered investigational to use ponatinib in combination with~     chemotherapy to treat PH+ or BCR-ABL positive ALL.~      The study doctor can explain how the study drugs are designed to work.~      Up to 60 participants will be enrolled in this study. All will take part at MD Anderson.~   "
32045|NCT03147599|"~     A randomized controlled trial to assess clinically the efficacy of the selective ileum~     spasmolytic mebeverine on daytime incontinence and nocturnal enuresis of orthotopic w-ileal~     neobladders and quality of life effect within 1 year post-surgery.~   "
32046|NCT03147586|"~     This is a randomised double-blinded placebo-controlled phase IV trial with two parallel~     treatment groups receiving either immune nutrition diet (IND) or conventional diet for 2weeks~     peri-radical cystectomy. Patients will be stratified according to the gender, body mass~     index, and the type of urinary diversion (orthotopic neobladder or ileal conduit). The~     primary end-point is to determine, in intention to treat analysis, the influence of IND on~     90-day postoperative morbidity. Secondary study end-points will be the effect of IND on~     infectious as well as non-infectious complications over 90 days, compliance and adverse~     effects of IND. Finally, an ancillary study will be performed to evaluate whether the IND~     costs could counterbalance, by its benefits, the health care costs.It is envisaged to finish~     patients' recruitment within 24 months~   "
32047|NCT03147573|"~     Blood pressure measurement methods and conditions are determinants of hypertension diagnosis.~     The classical methods such as office blood pressure measurement (OBPM) and home blood~     pressure monitoring (HBPM) have significant limitations. A recent British guideline~     recommends systematic 24-hour ambulatory blood pressure monitoring (ABPM). However, these~     devices are not available at all health centers and they can only be used by one patient per~     day. The aim this study is to validate a new method, 1-hour blood pressure monitoring (1BPM),~     to diagnose the hypertension.~      Participants with suspected hypertension will be recruited from a population of patients seen~     at three primary health centers in an urban area. According to the sample size estimation, a~     minimum sample size of 214 participants would be needed for the study. Four diagnostic tests~     will be performed: OBPM at three visits, HBPM, AMPM and 1BPM. The test order for the 24-hour~     monitoring, and 1-hour monitoring, will be set randomly. Daytime records of ABPM will be~     compared to all other monitoring methods using the correlation coefficients and Bland Altman~     plots. The Kappa index will be used to calculate degree of agreement. The sensitivity and~     specificity of the methods will also be calculated.~   "
32048|NCT03147560|"~     The purpose of this study is to evaluate the immunogenicity and safety of different~     sequential immunization strategies by Sabin IPV and bOPV in Chinese infants.~   "
32049|NCT03147547|"~     This study evaluated the effectiveness of strategies for engaging parents into parenting~     programs. Engagement strategies included a booklet showing testimonial quotes and photos from~     prior participants, a recommendation to attend for the child's teacher, and a motivational~     call from the parenting program provider. It was hypothesized that the combination of~     engagement strategies would increase attendance at a parenting intervention compared to~     receiving only a promotional brochure and research interview.~   "
32050|NCT03147534|"~     Compare and assess the accuracy and reliability of the InstaTemp MD® device to techniques~     presently in use for measuring temperature in infants and children in a Canadian clinical~     setting.~   "
32051|NCT03147521|"~     Accidental falls represents an elderly very important health problem, both in the community~     and within the hospital. The aim of this research project is to evaluate the effectiveness of~     accidental falls prevention care bundle in geriatrics, internal medicine, post acute, and~     rehabilitation wards, in terms of incidence and outcome reduction. It will be also~     investigated the cost effectiveness ratio, in terms of falls avoided, care bundle~     implementation costs, and falls related healthcare costs. The study will permit to evaluate~     the implementation feasibleness in time, considering the study will last for 20 months.~   "
32052|NCT03147508|"~     The goal of is this study is to investigate the reliability and validity of a classification~     system for neck pain patients. In a previous study clinical experts were asked about the~     clinical criteria they considered to be determinative for 5 predefined dysfunction patterns~     in patients with neck problems: 1) articular, 2) myofascial, 3) neural, 4) central, and 5)~     sensorimotor control dysfunction pattern. This Delphi survey revealed a list of pertinent~     anamnestic and clinical criteria per dysfunction pattern.~      In the present study we will collect anamnestic and clinical data of 200 neck pain patients.~     This will be obtained by approximately 20 clinicians that fill out a standardized~     registration form at the intake of their patients with neck pain.~      The therapists and patients will receive an informed consent that clarifies the purpose of~     the study and what happens next with the collected data.~      Per patient the therapist indicates the dominant clinical pattern based on his/her~     experience. Prior to the data analysis, the researchers will be blinded to the patient~     identification data. Subsequent, the registration forms will be screened for the presence of~     clinical criteria (obtained from previous Delphi study), independent of the therapist's~     diagnosis/conclusions. A second independent researcher will gather this information, which~     will be used for statistical analysis, in order to investigate which clinical criteria can be~     considered as determinative for a particular pattern. Outcome measures for these analysis~     are:~        -  sensitivity and classification specificity~        -  (positive and negative) likelihood ratios~        -  odds ratios~        -  diagnostic accuracy~   "
33165|NCT03132935|"~     Telemedically supported paramedic care of acute coronary syndromes was compared to a~     historical control period of solely conventional on-scene physician care. Quality outcomes~     based on current guidelines were researched als well as time requirements in both groups.~   "
32054|NCT03147469|"~     The influence of different head and neck positions on the effectiveness of ventilation with~     the Ambu AuraGain airway remains unevaluated.~      This study aimed to evaluate the influence of different head and neck positions on~     ventilation with the AuraGain airway.~      AuraGain will be placed in all patients, and mechanical ventilation will be performed using a~     volume-controlled mode with a tidal volume of 10 ml/kg.~      The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and~     ventilation score will be assessed first for the neutral head position and then for the~     extended, flexed, and rotated head positions in a random order.~      Fiberoptic bronchoscopic view will be also assessed for each head and neck positions.~   "
32055|NCT03147456|"~     One of the most common post-operative deficiencies or complications of bariatric surgery is~     protein malnutrition. It may lead to many predicaments such as malnutrition, vitamin, micro-~     and macronutrient deficiencies that can lead to deleterious consequences. A protein-rich diet~     make a person feel satiety and thereby the consumption will be low in overall energy intake.~     The objectives of our study are. The aim of this study is to assess the effect of protein~     supplementation on changes in health parameters such as fat mass, muscle mass, weigh change,~     protein (total and albumin), Vit B12, Zinc and Magnesium, in Qatari patients post bariatric~     surgery. Our participants are Qatari aged 18-45 years males and females recruited from the~     bariatric surgery centers of 2 major HMC hospitals (HGH hospital) and will be randomized to~     receive either the protein supplement (treatment group) or a dietary advice (control group).~     All participants will be equally followed and monitored for 3 months and data on the above~     parameters will be collected, together with other population characteristics, at Baseline, 1~     month and 3 month. Data will then be analyzed using the most up-to-date SPSS statistical~     package to assess the effect of protein supplementation on the parameters of interest.~     Statistical measures will be carefully chosen to properly assess the difference in the~     treatment (protein supplementation) effect compared with the control (Dietary advice).~     Investigators hypothesize that Patients receiving protein supplement (intervention group)~     Compared with patient not on protein supplement (placebo group) will maintain weight loss and~     other essential health parameters.~   "
32056|NCT03147443|"~     Treatment based on syndrome differentiation is the essence of traditional Chinese~     Medicine(TCM) and forms the individualized treatment. N-of-1 trials may be a good clinical~     effect evaluation method for the individualized treatment of TCM. This study aims to compare:~     (1) the efficacy of syndrome differentiation(individualized decoction) with placebo, (2)the~     efficacy of syndrome differentiation(individualized decoction) with the same prescription~     minus heat-clearing Chinese herbs, for patients with stable bronchiectasis through N-of-1~     trials.~   "
32057|NCT03147430|"~     This is a non-treatment study. It will not involve the use of any investigational drug or~     device. Potential participants will be enrolled through direct contact with collaborating~     clinical sites when the patient's annual 3D mammogram report yields a BIRADS rating of 4-5.~     The clinical Investigators or a member of their staff will conduct consent discussion once a~     suspicious mammogram report is identified or if a patient is referred for imaging of a~     suspicious area in the breast. After consenting the participant will be asked to donate a~     blood sample, a saliva sample, medical records pertaining to the suspicious mammogram report~     and a medical history questionnaire. The participants will be followed after one year to~     capture progression or resolution of their suspicious mammogram report. After a biopsy~     confirms the diagnosis of cancer or benign lesion, a recut sample of the tissue may be~     requested for research.~   "
32058|NCT03147404|"~     Phase II study of avelumab in metastatic gastronetro-pancreatic (GEP) neuroendocrine~     carcinoma (NEC, WHO grade 3) as second-line treatment after failing to etoposide+cisplatin:~     integration of genomic analysis to identify predictive molecular subtypes~   "
32059|NCT03147391|"~     The study was to retrospectively analyse the efficacy and safety of LAA closure using the~     LAmbre in our center from April 2014 to November 2015.~   "
32060|NCT03147378|"~     This study aims to evaluate the effect of food on the pharmacokinetics of ModraDoc006 in~     combination with ritonavir, in an open-label, cross-over design. Patients will be randomized~     into two treatment groups receiving ModraDoc006/r week 1 under fasting and week 2 under fed~     condition, or vice versa.~   "
32061|NCT03147365|"~     -  To compare between modified strength training program and aerobic exercises on quality~          of life on children with Acute Lymphoblastic Leukemia.~        -  To compare between modified strength training program and aerobic exercises on~          functional capacity on children with Acute Lymphoblastic Leukemia.~   "
32062|NCT03147352|"~     The investigators will analyze biomarkers related to the prognosis and treatment of~     necrotizing soft tissue infections (NSTI). The focus will be on whether certain endothelial~     and immune system biomarkers can function as markers of disease severity, mortality as well~     as the effects of hyperbaric oxygen therapy (HBOT). Biomarkers will be measured upon~     admission to an intensive care unit at Copenhagen University Hospital and during the~     following 3 days.~   "
32063|NCT03147339|"~     To evaluate the effects of dietary restriction of advanced glycated end products (AGEs) on~     glycemic control, oxidative stress and systemic inflammation, in a randomized, 44 subjects~     with metabolic syndrome for 8 weeks.Both groups will be advised to follow same low energy~     diet and no changing in physical activity pattern.Parameters related to metabolic syndrome,~     anthropocentric factors, oxidative stress(Malondialdehyde), CML(AGEs factor in blood) and~     systemic inflammation factors (hs-CRP وTNF-α ) will be measured at the baseline and at the~     end of the study.~   "
32064|NCT03147326|"~     The purpose of this study is to compare the current standard whole-body x-ray with the~     advanced imaging techniques FDG-PET-CT, NaF-PET-CT and whole-body MRI in the detection of~     myeloma bone lesions.~   "
32065|NCT03147313|"~     This study evaluates the impact of extracorporeal shock wave treatment after microsurgical~     coaptation of finger nerves. Participants will be randomized into two treatment groups with~     different settings and a sham group. The participants will thereafter followed-up in a~     prospective, double-blind study design.~   "
32080|NCT03147118|"~     The objective of this study is to evaluate the accuracy of trapeziometacarpal injections~     using palpation alone. The importance of this study is one of education, cost containment,~     and decreased risk to the patient. If it can be shown that the accuracy of trapeziometacarpal~     injections using palpation alone is similar to the reported accuracy of ultrasound and~     fluoroscopy, then these guided techniques may not be needed.~   "
32066|NCT03147300|"~     POPULATION: Low back pain (LBP) is a major health problem commonly requiring health care. In~     Sweden, primary care professionals require an evidenced based model of care for LBP.~      INTERVENTION: The multi-faceted implementation of a best practice BetterBack model of care~     for LBP.~      CONTROL: Current routine practice for LBP care before implementation of the BetterBack model~     of care.~      OUTCOME: Patient reported measures (function, activity, health), therapist reported measures~     (diagnosis, intervention, specialist referral, best practice self-confidence, determinants of~     implementation) and cost-effectiveness.~      AIM: To deliver best practice recommendations for LBP and study their most effective~     implementation through the BetterBack model of care.~      METHOD: A cluster randomised trial with dog leg design. The hypothesis is that the BetterBack~     model of care will result in significantly better patient and therapist outcomes as well as~     cost-effectiveness compared to current routine care.~   "
32067|NCT03147287|"~     This research study is studying three combinations of drugs as treatments for breast cancer.~      The drugs involved in this study are:~        -  Fulvestrant~        -  Fulvestrant with Palbociclib~        -  Fulvestrant with Palbociclib and Avelumab~   "
32068|NCT03147274|"~     SMART T1D is a research study that offers interactive diabetes education for teens with type~     1 diabetes in peer groups led by diabetes nurse educators. Participants in the study will be~     randomly assigned to either receive three of the group sessions in addition to their routine~     clinic care or to receive their usual diabetes clinic care.~   "
32069|NCT03147261|"~     Central obesity, present in the metabolic syndrome (MS), is associated with increased risk of~     insulin resistance (RI). The aim of the project is to evaluate the protective effect of~     comprehensive intervention (Mediterranean diet + physical activity) in the development of RI~     in children with central obesity based on genetic and epigenetic markers.~   "
32070|NCT03147248|"~     This is a Phase I/III Study to Evaluate Efficacy, Pharmacokinetics and Safety between CT-P13~     SC and CT-P13 IV in Patients with Active Rheumatoid Arthritis.~   "
32071|NCT03147235|"~     This will be a prospective, randomized controlled trial with patients randomly assigned to~     either the experimental or control group. The experimental group will be exposed to the~     independent variable (IV) and the control group will not be exposed to the IV. The IV will be~     a music therapist- designed listening program during surgery. A total of 60 patients will be~     consecutively enrolled and undergo block randomization to either a music listening group or a~     control group (no music). Trained medical research personnel will assist with various parts~     of the study and will be defined as those individuals who have completed and are up-to-date~     on the Collaborative Institutional Training Initiative (CITI) training. These individuals~     will consist of a board certified music therapist, practicing ophthalmologists, and~     physicians-in-training.~   "
32072|NCT03147222|"~     This pilot study will evaluate the feasibility of implementing an intervention in the home~     setting that is specifically designed to coach and mentor caregivers as they assist~     individuals with Alzheimer's disease and related dementia (ADRD) who have fractured a hip to~     perform everyday activities and engage in more physical activity.~   "
32073|NCT03147209|"~     Truckers face many unique challenges in their work that may adversely impact their health,~     including time constraints, sedentary job tasks, and a 'moving-workplace' environment with~     associated limitations to access healthy food and safe places to be physically active. These~     issues make it difficult to form and maintain healthy lifestyle habits and contribute to the~     high prevalence of injuries from both crashes and falls among truckers is supported by an~     increase in obesity among truckers with longer durations of employment.~      The investigators propose to develop and pilot test the Exercise Intervention of the Worksite~     Health, Eating and Exercising for the Long-haul (WHEEL)'s weight loss intervention. This~     pilot exercise intervention is aimed at achieving meaningful improvement in grip strength,~     balance, and gait over 6 weeks. The investigators will use pilot sample of 15 obese (BMI ≥ 30~     kg/m2) truckers, documenting changes in these measures. Individualized assessments will be~     utilized. The investigators will aim to complete the following:~        1. Evaluate the feasibility of the PIE WHEEL intervention for CMV drivers will result in~          greater strength comparing baseline with 6 week outcomes.~             1. Determine the extent to which drivers will participate in PIE WHEEL~             2. Determine the extent of change in strength, balance and gait realized by PIE WHEEL~               participation~        2. Evaluate safety events (crashes, near misses, falls) in the week prior to PIE WHEEL and~          the final week of PIE WHEEL a. Solicit driver perceptions of their own safety of ingress~          and egress related to PIE WHEEL participation~   "
32074|NCT03147196|"~     This phase II pilot trial studies how well bicalutamide and raloxifene hydrochloride work in~     treating patients with prostate cancer undergoing surgery. Antihormone therapy, such as~     bicalutamide and raloxifene hydrochloride, may lessen the amount of androgens made by the~     body.~   "
32075|NCT03147183|"~     Renal transplant candidates who have CMV-specific, CD8+ T-cells, are CMV-seropositive and~     carry HLA-A1 and/ or HLA- A2 alleles have a high probability to maintain this type of~     immunity during the three first months after the transplant, despite induction~     immunosuppressive therapy (thymoglobulin).~   "
32076|NCT03147170|"~     The investigators are proposing that individuals with elevated levels of NT-proBNP are~     resistant to natriuretic peptides and are unable to handle sodium loads and maintain optimal~     blood pressure values.The investigators will test this hypothesis by comparing the blood~     pressure response to low and high salt diets in individuals with pre- or hypertension and who~     have normal or elevated levels of NT-proBNP. The investigators expect that blood pressure~     values in those with normal levels of NT-proBNP will not change with high salt diets,~     whereas, in those with elevated levels of NT-proBNP, blood pressure values will increase~     significantly when exposed to high salt diets.~   "
32077|NCT03147157|"~     The aim of this research is to design a randomized controlled clinical study, which is based~     on HLA matching rate to guide tacrolimus regimen. In this study, the possibility of~     tacrolimus regimen guided by HLA matching rate will be explored, the occurrence rate of GVHD~     and rejection reaction will be observed, and the occurrence time and degree of adverse~     reactions caused by immune inhibitors will be identified. In the meantime, providing a~     possible prospect for prevention of GVHD and reduction or removal of immune inhibitors.~   "
32081|NCT03147105|"~     Chronic progressive multiple sclerosis patients will be randomised to home-based arm~     ergometry training for 12 weeks or a waitlist control group which will have access to the~     treatment after 12 weeks when primary endpoint assessment has been obtained. Assessments~     include clinical outcomes and questionnaires as well MRI imaging and transcranial magnetic~     stimulation paradigms. Primary endpoint will be the 6 minute walking test at week 12.~   "
32082|NCT03147092|"~     Background Hypertension is the main risk factor for most cardiovascular diseases. Blood~     pressure (BP) control has been shown to reduce the incidence of stroke, myocardial~     infarction, renal diseases and heart failure. Although BP lowering is effective, few~     population programs can achieve BP control. A coordinated and organized system from the~     Brazilian Ministry of Healthy involving Family Health Strategy (FHS), a program for the~     prevention of chronic disease, and the Popular Pharmacy Program (PPP), which subsidizes~     medications for the population, could allow an earlier identification and better BP control.~     Matão Controlling Hypertension (MatCH) is a community-based population project that aims to~     apply an organized, integrated and coordinated program in the city of Matão, Brazil,~     involving FSH and PPP in order to actively search, treat and follow-up hypertensive subjects.~      Method This is a population community-based, prospective, interventional, follow-up study~     where all subjects aged ≥ 40 years assisted by the FHS program in Matão will have BP assessed~     monthly by trained Community Health Agents (CHA) during a domiciliary visit. Identified~     hypertensive subjects will be referred to FHS physicians for nonpharmacological and~     pharmacological treatment. Most of the hypertensive drugs used will be available thought the~     PPP. Prevalence of hypertension, awareness, demographics and risk factors will be correlated~     with BP control. The population study is expected to involve approximately 15,000 subjects.~     The study period will be four years.~      Discussion Considering that hypertension is asymptomatic in most cases, to reduce the~     population burden of BP-related deaths and diseases it is essential to detect and treat early~     all hypertensive patients. If BP control be achieved on a large scale, this program can be~     applied to other populations from developing countries.~   "
32083|NCT03147079|"~     The purpose of this study is to determine whether a behavioural intervention focusing on diet~     and physical activity is cost-effective in decreasing weight gain during pregnancy among~     pregnant women with body mass index above 30, and has effect on the weight of offspring at~     birth and at 2.5 years of age~   "
32084|NCT03147066|"~     This study evaluates the efficacy of dezocine in preventing the catheter-related bladder~     discomfort (CRBD) in a postanesthesia care unit (PACU).~   "
32085|NCT03147053|"~     To explore the efficacy and safety of Jiedu Tongluo granules for post stroke depression. A~     randomized, double-blind, placebo-controlled clinical trial was designed. The treatment group~     was administered the Jiedu Tongluo granules, while the control group was administered the~     placebo.~   "
32086|NCT03147040|"~     This is a single arm multicenter non-randomized phase II trial testing the efficacy of the~     combination of carboplatin plus atezolizumab in metastatic ILC~   "
32087|NCT03147027|"~     Despite established implantable cardioverter-defibrillator (ICD) therapy and catheter~     ablation for sustained ventricular tachycardia (VT) in patients with ischemic heart disease~     (IHD) and reduced left ventricular ejection fraction (LVEF), the efficacy of catheter~     ablation in patients with nonsustained VT has been not yet clarified. The incidence of~     appropriate ICD therapy itself has been reported to be a worse prognostic factor in patients~     with reduced LVEF. Therefore theoretically the inhibition of these ventricular incidences can~     result in the prognostic improvement.To suppress ventricular arrhythmias aside from~     antiarrhythmic agents, catheter ablation has been developed prominently in this decade along~     with the technological improvement such as irrigated ablation catheters, three-dimensional~     mapping systems, multi-polar catheters, and image integration system with CT and MRI. The~     rationale of this trial is to study the efficacy of the eradication of arrhythmogenic~     substrate in ischemic cardiomyopathy with reduced LVEF and nonsustained VT on prevention of~     the occurrence of sustained VT/VF and ICD therapies.~   "
32088|NCT03147014|"~     Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart Disease~   "
32089|NCT03147001|"~     A randomized interventions study using a crossover design. Ten well trained triathletes or~     bikeriders will be included for to undergo two trail separated by about 3 weeks. The night~     before the trail each subject will performe a high intense interval trainings session on an~     ergometer bike. during the night an infusion of aminoacid tracers will be initiated. The~     subject is woken at 6.30 a.m. Blood samples and a musclebiopsy will be collected prior to the~     morning bike ride at 8.00a.m. Immediately before the morning bike ride is started the subject~     will ingest a drink of 0,5g protein or a non-caloric placebo (random order). During the bike~     ride and the following 4,5 hours blood will be drawn with regular intervals. at time point 0,~     60 and 180 min after the training session biopsies are collected.~   "
32090|NCT03146988|"~     Single-centre, double-blind, randomised, two-period, two-way crossover study to investigate~     the pharmacokinetics and pharmacodynamics of RGB-02 as compared to Neulasta® administered as~     a single subcutaneous injection in healthy adult subjects.~   "
32091|NCT03146975|"~     Human immune system produces many different factors, which will influence health-disease~     statuses. This partially explains why under similar conditions only some people become sick.~     Therefore, specific analyses of such factors in healthy and diseased patients are crucial for~     a better knowledge about diseases development and successful treatments. Human beta defensins~     (hBD) may have a key role in patient's susceptibility to gum diseases. In the lab, high~     levels of sugar (glucose) could inhibit their expression and contribute to the occurrence of~     infections associated with diabetic wounds. This study will evaluate if treatment of the most~     common gum disease in adults influences production of beta defensins by gingiva. Also,~     clinical improvements and treatment effects on blood glycemic levels will be monitored~     throughout a 2-month period. Patients with or without gum diseases and with or without~     diabetes mellitus will be able to participate. After a complete oral examination to determine~     periodontal status, gingival fluid samples will be collected using paper strips. These~     samples will be collected before and also two-months after oral treatment and will be~     analyzed by an immune-enzymatic test named ELISA (Enzyme-Linked Immunosorbent Assay). In~     weekly sections, one trained specialist will performed treatment of gum diseases under local~     anesthesia using hand-instruments. Researchers hypothesized that a) levels of defensins would~     be lower in the presence of periodontal disease when compared to a healthy periodontal~     condition; b) diabetes would influence production of these immune protective factors; and c)~     treatment would provide a greater beneficial amount of defensins.~   "
32092|NCT03146962|"~     This is a single arm, 2-cohort, open-label trial of high dose Vitamin C intravenous infusion~     in subjects with solid tumor malignancies who are eligible for resection (cohort A) or with~     KRAS or BRAF mutant metastatic cancer who have received prior systemic treatment (cohort B).~   "
32094|NCT03146936|"~     The investigators wish to collect high quality prospective data on a rare disease in order to~     elucidate epidemiology, natural history, response to treatment and outcome. In addition, a~     biobank allows addressing specific scientific issues on a variety of open questions. The~     cohort will provide a platform for carrying out scientific research projects on PSC. In~     addition, the cohort will allow collaborations with reference networks on PSC abroad~   "
32095|NCT03146923|"~     Based on new evidence renal dietitians in Ireland are revising the diet sheet that is used to~     teach patients about reducing blood phosphate. Changes that renal dietitians plan to make to~     the dietary phosphorus prescription~        -  Inclusion of some nuts and pulses~        -  More detailed education re phosphate additives~        -  More accurate protein prescription~        -  Inclusion of more whole grains~        -  Encouraging the use of foods with a low phosphorus to protein ratio~      The investigators want to test the two diet prescription to find out, which one is better at~     reducing blood phosphate and which one is more acceptable to patients. The investigators also~     want to make sure it is safe.~   "
32096|NCT03146910|"~     Research project in which biological material is sampled and health-related medical data is~     collected. In addition, already existing health-related medical data are used for further~     research. Coded data are used.~   "
32097|NCT03146897|"~     The research seeks to determine the relative effectiveness and cost effectiveness of~     alternative supplementary foods in the treatment of moderate acute malnutrition (MAM) in~     normal program settings. The results of this study will guide decisions about what~     commodities to use in supplementary feeding programs in particular contexts and populations,~     and what factors need to be addressed to ensure maximum effectiveness in the treatment of~     moderate malnutrition.~      Tufts University, Washington University in St. Louis, School of Medicine, Sierra Leone~     Ministry of Health and Sanitation (MoSH), Project Peanut Butter, Caritas Bo, World Food~     Programme (WFP), and the United States Agency for International Development (USAID) are~     collaborating to conduct an assessment of the effectiveness, cost, and cost-effectiveness of~     food aid commodities in treating moderate acute malnutrition (MAM) in young children. The~     study comparison is based on a targeted food delivery to children 6-59 months who are~     screened for MAM. Study participants will receive one of four approximately isoenergetic test~     foods:~        1. Super Cereal Plus (SC+) with amylase~        2. Corn-soy Blend Plus (CSB+) and oil~        3. Corn-soy Whey Blend (CSWB) and oil (CSWB is a new product which is a modified version of~          CSB)~        4. Ready-to-use Supplementary Food (RUSF, lipid-based)~   "
32098|NCT03146884|"~     Research project in which biological material is sampled and health-related personal data is~     further used and collected.~      Coded data are used.~   "
32099|NCT03146871|"~     This trial studies the side effects of recombinant EphB4-HSA fusion protein when given~     together with azacitidine or decitabine in treating patients with myelodysplastic syndrome,~     chronic myelomonocytic leukemia, or acute myeloid leukemia that has come back or has not~     responded to previous treatment with a hypomethylating agent. Recombinant EphB4-HSA fusion~     protein may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Hypomethylating agents, such as azacitidine and decitabine, slow down genes that~     promote cell growth and can kill cells that are dividing rapidly. Giving recombinant~     EphB4-HSA fusion protein together with azacitidine or decitabine may work better in treating~     patients with myelodysplastic syndrome, chronic myelomonocytic leukemia, or acute myeloid~     leukemia.~   "
32100|NCT03146858|"~     Heart attacks are caused by a clot blocking one or more of the heart arteries (coronary~     arteries). When complete blockage of one of the arteries occurs, emergency treatment to~     unblock the affected artery and rescue the heart muscle at risk is essential. This is usually~     achieved by performing an emergency procedure called primary percutaneous coronary~     intervention (PPCI).~      Anticlotting treatment is also necessary to reduce the chances of further heart attacks. As~     part of standard care, tablets that target small cells called platelets (central to blood~     clot formation) are given as soon as an acute heart attack is suspected. These tablets~     include aspirin and ticagrelor/prasufrel. Although both ticgrelor and prasugrel are~     effective, the onset of action is delayed by up to 8 hours when given in context of an acute~     heart attack. This delay in onset of action can increase the risk of further heart attacks.~      Enoxaparin is an anticlotting treatment that targets the other aspect of clot formation known~     as coagulation cascade. Enoxaparin or an alternative is recommended as a single does to~     support the PPCI procedure. The effects of a single shot of enoxaparin do not last long~     enough to bridge the gap in anticlotting treatment caused by the delayed action of~     ticagrelor/prasugrel. Since the investigators have realised the delayed onset of action of~     tablet therapy, the investigators have been using another drug called tirofiban as a drip.~     Tirofiban blocks platelets effectively, but greatly increases the risk of bleeding events.~      The investigators believe that giving enoxaparin as a drip for 3-6 hours (following the~     single dose) instead of tirofiban, would be sufficient to bridge the gap in anticlotting~     effect without greatly increasing the risk of bleeding. This is a pilot study to assess the~     effects of enoxaparin drip in patients presenting with acute heart attacks and undergoing~     emergency treatment with PPCI.~   "
32101|NCT03146845|"~     Some wounds are very slow to heal. Keeping moisture at the right level in a wound is very~     important, so wounds are almost always kept covered while they are healing. There are many~     different dressings that can be used to cover a wound. These dressings have different~     capabilities in handling the fluid that comes out of a wound. Some dressings can only be worn~     for a few days, while others may be worn up to 7 days. Dressings with short wear times may~     require more visits to the doctor's office for changes, while dressings with a longer wear~     time may mean fewer visits to doctor's office.~      Allevyn Life Non-Bordered is a new 4 layer dressing intended to cover wounds that have~     moderate to heavy fluid secretion. Allevyn Life Non-Bordered can be left on a wound for up to~     7 days.~      This study will evaluate subject satisfaction with the dressing when used on a wound.~   "
32102|NCT03146832|"~     The goal of the present study is to compare different therapeutic strategies (according to~     habituation model vs. according to the inhibitory learning approach) during exposure to~     thermal pain in an experimental design.~   "
32103|NCT03146819|"~     This study is designed to compare outcome data for patients who have recently undergone~     surgery with the iTotal® Posterior Stabilizing (PS) Knee Replacement System (hereafter~     referred to as the iTotal) versus those who have undergone surgery with Off-the-Shelf (OTS)~     systems.~   "
32137|NCT03146377|"~     This is an open-label, single centre, single-arm phase II study which aims to assess the~     efficacy and tolerability of triplet combination of capecitabine, oxaliplatin and irinotecan~     (Xeloxiri regimen) in treating patients with refractory metastatic colorectal cancer.~     Clinical data from patients diagnosed with colorectal cancer will be collected and analyzed~     in this study. The patients' data will be collected and maintained in the Division of medical~     oncology of the Department of Medicine, Queen Mary Hospital.~   "
45628|NCT02969616|"~     This prospective, post-market, open label clinical study is designed to examine the lumbar~     fusion rate at 24 months post operative in subjects who have undergone a lumbar fusion~     surgery using Trinity Elite with or without local bone.~   "
32104|NCT03146806|"~     The main purpose of this study is to determine the safety, feasibility, and utility of~     intranasal (NAS) ketamine in persistent uncontrolled cancer related pain. In this prospective~     clinical trial the researchers will investigate the use of NAS ketamine in patients with pain~     related to cancer or cancer treatment. The researchers plan to enroll at least 25 patients~     meeting inclusion/exclusion criteria, to achieve a minimum of 10 patients who complete the~     study. Participants will be recruited from the supportive oncology clinic, oncology clinics,~     the pain clinic and Acute Pain Service at Emory. Participants will be asked to return to the~     Phase I unit of the Winship Cancer Building C for a total of 5 study visits, each two to five~     days apart. During these visits participants will complete questionnaires, have blood samples~     drawn and will have study medication administered to them in escalating doses. For safety~     monitoring participants will be contacted by telephone 14 days after the last dose of~     medication administered.~   "
32105|NCT03146793|"~     The national drug safety agency authorizes nominatively the use of sodium thiosulfate in~     dialysis patients with calciphylaxis. To date, it is the largest global cohort (more 600~     patients from 2012 to 2016). We wanted to study retrospectively the fate of these patients at~     6 months including mortality. Early use improves effectiveness.~   "
32106|NCT03146780|"~     This study aims to compare how a single cap best fit on a tooth that is fabricated with~     digital and conventional impression techniques.~   "
32107|NCT03146767|"~     The staircase phenomenon could have repercussions on the onset and recovery time following~     administration of a neuromuscular blocking agent. The investigators aim to assess the~     magnitude of the staircase phenomenon and its impact on various aspects of neuromuscular~     blockade with a randomized controlled double blind trial.~   "
32108|NCT03146754|"~     This is an exploratory study to evaluate lung ultrasound as a method for measuring~     extravascular lung water in stabilized patients during hospitalization for ADHF. Subjects who~     have been stabilized following admission for ADHF and capable of lying supine will be~     evaluated by lung ultrasound to determine the degree of lung congestion as measured by the~     total B-line score. Since different patients may require different degrees of postural change~     and/or other maneuvers (e.g., leg elevation or exercise) to induce B-line increments, a~     tailored sequential protocol will be employed to define which maneuvers are sufficient for~     each patient.~   "
32109|NCT03146741|"~     This study is being conducted to determine safety and effectiveness of transplanting hearts~     from Hepatitis C-positive donors into Hepatitis C-negative patients on the heart transplant~     waitlist, who will then be treated with Zepatier after transplantation.~   "
32110|NCT03146728|"~     There are over 44,000 persons living with spinal cord injury (SCI) in Canada, who face~     substantial challenges in maintaining a healthy body composition after injury. As a result,~     obesity, diabetes and cardiovascular disease are prevalent in this population. Guidelines~     indicating that twice weekly 20-minute sessions of exercise (plus resistance training) will~     increase physical fitness in those with SCI have been recently published. However, no~     SCI-specific guidelines indicating the volume of exercise to reduce the risk of developing~     obesity-related diseases exist. Longitudinal studies indicate that a weekly exercise-related~     energy expenditure of 2000 - 2500 Calories is correlated with the least likelihood of~     cardiovascular disease in the able-bodied population. There is little information regarding~     energy expenditure (EE) for activities carried out by persons with SCI, with less available~     for persons with tetraplegia. Once known, this EE data can be used to develop exercise~     interventions to determine the volume of voluntary exercise required to reduce obesity and~     risk factors for diabetes and cardiovascular disease in those living with tetraplegia.~   "
32111|NCT03146715|"~     Background: In a previous study, children who consumed a high-carotenoid juice over 8 weeks~     significantly increased skin carotenoid levels as compared to children who consumed a placebo~     juice. A naturally carotenoid-rich baked product, potentially marketable as a healthy~     breakfast food alternative, was developed by Utah State University researchers.~      Objective: To determine the effect and response of a carotenoid-rich baked product on change~     in skin carotenoid levels among children.~      Design: A six week randomized controlled trial. Participants/setting: Participants were~     children age 5-18 during March-June, 2015 living in Cache County, UT (n=46). Intervention:~     Children were randomly assigned to one of two groups: treatment (n=23) with a high carotenoid~     baked food or control (n=25) who consumed a baked food with no carotenoids. Children were~     asked to eat the designated portion of the assigned food once a day for six weeks. Skin~     carotenoid levels were measured every two weeks by a BioPhotonic scanner and reported in~     Raman intensity counts. Participants were asked to maintain their diet and completed a food~     frequency questionnaire at Baseline, Week 3, and Week 6. Uneaten portions of the food were~     returned to clinic, counted, and recorded.~      Main outcome measures: Change in skin carotenoid levels as measured in Raman counts over 6~     weeks.~      Statistical analysis performed: Repeated-measures ANOVA was used to assess the group~     differences in Raman counts.~   "
32112|NCT03146702|"~     Pulmonary Hypertension (PH) is a hemodynamic and physiopathological condition that is defined~     as an increase in mean pulmonary artery pressure ≥25 mmHg when measured at rest. PH often~     progresses to heart failure and premature deaths. PH is a progressive disease that has many~     causes, which can affect people of all ages, is characterized by shortness of breath, reduced~     exercise tolerance, psychological distress and tiredness and reduced quality of life. Surveys~     of SF-36, 'Nottingham Health Profiles' and 'Minnesota Life with Heart Failure' surveys are~     routinely performed in PH clinically. However, none of the questionnaires are specific to~     pulmonary hypertension, so they are incomplete in determining the condition of the disease~     and the patients. There is no Turkish questionnaire for patients with pulmonary hypertension~     and other surveys used are inadequate in determining the condition of the patient and the~     patient since they are not specific to the disease. The aim is to provide a Turkish~     questionnaire that is specific to pulmonary hypertension in the literature.~   "
32168|NCT03145974|"~     This study is an extension of the Spanish Initiative for Epidemiology, Stratification and~     Therapies of Acute respiratory failure (SIESTA) Network.~      The present study is aimed to establish the epidemiological characteristics and clinical~     outcomes of mechanically ventilated patients with acute hypoxemic respiratory failure~     [defined as a PaO2/FiO2 ≤300 mmHg on positive end-expiratory pressure (PEEP) of 5 cmH2O or~     more, and FiO2 of 0.3 or more] admitted in a network of Spanish hospitals.~   "
32113|NCT03146689|"~     Despite evidence that topical non-steroidal anti-inflammatory drugs (NSAIDs) and capsaicin~     are effective in osteoarthritis (OA), it is still unclear why they work for some people but~     not others. The investigators are undertaking an individual patient data (IPD) meta-analysis~     to identify responders according to patient characteristics, however, no studies report the~     presence of synovial hypertrophy or neuropathic-like pain. These two traits are of interest~     as they may be used to optimise the treatment effects of the two drugs which work via~     different mechanisms to reduce pain in OA. The investigators are therefore conducting this~     pilot n-of-1 trial series.~      This pilot n-of-1 trial series will investigate whether a person with OA, who has a different~     balance between inflammatory and neuropathic pain, shows a preference between these~     mechanistically different treatments. The trial will also be used to offer recommendations on~     the use of n-of-1 trial series for individualised (precision) medicine in OA.~   "
32114|NCT03146676|"~     Analysis of Gene expression and microbiome profiling in hidradenitis suppurativa to identify~     immunological biomarkers of disease activity.~   "
32115|NCT03146663|"~     This study will evaluate the effect of two dose levels of NUC-1031 (500 mg/m2 and 750mg/m2)~     in patients with ovarian cancer. The primary objective is to determine the anti-tumor~     activity of NUC-1031 at the selected dose level (500 mg/m2 or 750 mg/m2).~   "
32116|NCT03146650|"~     This phase II trial studies the efficacy (the effect on the tumor) and the safety (the effect~     on the body) of the study drugs when given as a combination in participants with this type of~     cancer. Another purpose of the study is to see which tumor markers (proteins in the blood~     that the body produces in response to the cancer) lead to better results in participants~     treated with the study drugs. Nivolumab and ipilimumab are antibodies, which are human~     proteins that recognize and attach to a part of the tumor and/or body's immune cells. They~     work in slightly different ways to activate the immune system and help the body's immune~     system to work against tumor cells. Nivolumab and ipilimumab are investigational because they~     are not approved by the FDA to be used for the type of cancer being studied.~   "
32117|NCT03146637|"~     This is a phase II Randomized comparison clinical trial of PD-1 inhabitor activated CIK armed~     with anti-CD3-MUC1 bispecific antibody for advanced liver cancer. And the aim of this~     research is to study the clinical efficacy and safety of PD-1 activated CIK armed with~     anti-CD3-MUC1 bispecific antibody for liver cancer.~   "
32118|NCT03146624|"~     OBJECTIVE to evaluate patients satisfaction of obturator with attachment versus conventional~     obturator in treatment of unilateral maxillectomy .~   "
32119|NCT03146611|"~     Neutrophil CD64 versus Neutrophil/Lymphocyte ratio (NLR) as markers predicting in-hospital~     outcome in acute exacerbation of COPD~   "
32120|NCT03146598|"~     Transverse-plane foot deformities are a frequently encountered issue in children with~     neurological disorders. They are the source of many symptoms, such as pain and walking~     difficulties, making their prevention very important. It is thus important to prevent the~     occurrence of transverse-plane foot deformities and limit their development regarding the~     high risk of morbidity. In order to prevent such deformities, in the department of pediatric~     physical medicine and rehabilitation department of Lyon, since 2001 the investigator use a~     side pole static ankle foot orthosis (SPS AFO) in children with a neurological disorder~     predisposing such deformities. The aim of the study this study is to describe the use,~     tolerability and potential side effects of this orthosis in children with neurological~     disorders from the investigator's department~   "
32121|NCT03146585|"~     The hypothesis to be tested: GCX damage and its dynamics correlate to various patient related~     factors and to using organ-supporting measures. There is a correlation between length of~     organ support and GCX damage.~      The aim of the study: Evaluation of the relationship between GCX damage and duration of~     various organ supporting measures.~      Type of the study: Observational. Subjects: Adult patients admitted to ICU and requiring~     organ supporting therapy.~      Sample size: We plan enrollment of 75 patients on invasive ventilatory support in the~     duration of least 5 days, 50 patients on renal supporting therapy lasting at least 5 days and~     20 patients with target temperature management for neuroprotection.~      Intervention: none Data to be recorded and analysed: Demographics, type of patients (trauma,~     post surgical, medical, after cardiac arrest), severity score - Apache II, SOFA, fluid~     balance, presence of delirium, clinical outcome, sublingual microcirculation by SDF imaging~     at time points: before or at the start of organ support, after 24 hours (day 1), day 3, 5, 7~     and/or at discharge or before death, microcirculatory data, and Perfused Boundary Region.~   "
32122|NCT03146572|"~     The objective of this study to evaluate potential impact of a brief, low-cost primary~     care-based intervention of parenting self-efficacy, knowledge, and behavior.~   "
32123|NCT03146559|"~     The purpose of this study is to investigate learning transfer from the healthy hand to the~     paretic hand in stroke patients. EMG signals from the healthy hand - while performing wrist~     dorsi flexion movement - will be used to activate electric muscles stimulation of the dorsi~     flexors of the paretic hand.~   "
32138|NCT03146364|"~     This Cross-sectional Study Included Patients that diagnosed with schizophrenia, aged 18-55,~     20 of which hospitalized in mental health department and 20 in medical follow-up.~      Different test will be administered, in two or three sessions, to evaluate cognitive ability,~     function ability and participation.~      The results of the VIS shopping task performance (statically & dynamically) and its~     correlation with the cognitive and function tests as well as the participation questionnaire~     will be examined. These findings will indicate whether the shopping task is valid to assess~     executive functions for people with schizophrenia and whether it is ecologically valid.~   "
32139|NCT03146351|"~     Infant born preterm have an increased risk of adverse long-term developmental outcomes.The~     risk associated with preterm birth increase as gestational age decreases, and vulnerability~     remains in moderate and early preterm (<34 weeks) and late preterm (>34 weeks). There are~     many studies in the literature showed that the prevalence of developmental delay increases~     with premature birth. However, there is no study in the literature investigates effect of~     early intervention program motor performance in subgroups of preterm infants. Hence the aim~     of this study is to evaluate the differences in effects of early intervention program on~     motor development in early and moderate (<34 weeks) and late preterm infants.~   "
32124|NCT03146546|"~     Sepsis-induced immunosuppression affects all types of immune cells. Neutrophils are pivotal~     components of innate immunity and provide the first line of defense against invading~     microorganisms. After recruitment to the site of invading microorganisms, they phagocytose,~     kill and digest the microorganisms via well-orchestrated processes involving reactive oxygen~     species (ROS). However, neutrophils in sepsis demonstrate an immunosuppressed phenotype.(1)~     Reduced bacterial clearance, diminished production of reactive oxygen species (ROS), and~     impaired recruitment to the site of infection are the most prominent features.(2-4) Available~     data also reveal that neutrophil dysfunction develops prior to secondary infections, and~     patients with the most severely impaired neutrophil function carry the highest risk for~     secondary infections.(3) However, the mechanisms involved are still poorly understood.~      Hyperresistinemia in sepsis has been associated with a greater disease severity and a worse~     outcome.(5-7). The Investigator's prior work in vitro has demonstrated that hyperresistinemia~     reversibly hinders neutrophil migration by impairing F-actin formation.(8) The current~     project revolves around the overall hypothesis that resistin also impairs bacterial killing~     by inhibiting the intracellular generation of reactive oxygen species.~      While the study team has accumulated preliminary in vitro data supporting the inhibitory~     effect of resistin on neutrophils, it is imperative to confirm these findings in vivo.~     Specifically, the study team will need to study how serum resistin levels differ in patients~     with septic shock and acute kidney injury (AKI). Furthermore, it is essential to see how~     neutrophil function differs when exposed to serum from these two different patient~     populations (septic shock versus septic shock + AKI).~   "
32125|NCT03146533|"~     This is a clinical study to observe the maximum tolerated dose (MTD) and the safety and~     feasibility of chimeric antigen receptor 19 (CD19 CART) cells in relapsed and refractory~     patients with CD19+ B cell lymphoma.~   "
32126|NCT03146520|"~     Pivotal trials of SDC2 methylation biomarker test in stool DNA to estimate clinical~     sensitivity and specificity in detection of colorectal cancer.~   "
32127|NCT03146507|"~     The fetal heart plays a central role in the adaptive mechanisms for hypoxemia and placental~     insufficiency. Longitudinal data on the hemodynamic sequence of the natural history of fetal~     growth restriction show that the umbilical artery and middle cerebral artery are the first~     variables to become abnormal . These arterial Doppler abnormalities are followed by~     abnormalities in the right cardiac diastolic indices, followed by the right cardiac systolic~     indices, and finally by both left diastolic and systolic cardiac indices .~      Preserving the left systolic function as the last variable to become abnormal ensures an~     adequate left ventricular output , which supplies the cerebral and coronary circulations.This~     defence is contingent on the fetal cardiovascular system, which in late gestation adopts~     strategies to decrease oxygen consumption and redistribute the cardiac output away from~     peripheral vascular beds and towards essential circulations, such as those perfusing the~     brain.~      Adding cardiac Doppler may improve management of the IUGR fetus(intrauterine growth~     retardation), Doppler ultrasound is valuable in defining the degree of cardiovascular~     compromise in at-risk pregnancies. The severity of fetal blood flow redistribution shows the~     degree of fetal adaptation and provides information on how long the pregnancy can be~     continued safely.~      The aime of the study is assessment of cardiac output redistribution in fetal hypoxia by~     estimating relative right to left side cardiac output wich reflect cardiac sparing in (IUGR).~   "
32128|NCT03146494|"~     A total of 300 consecutive cardiac patients will receive preoperative thyroid function~     profile evaluation, including 150 patients with Standford type A aortic dissection (STAAD)~     and 150 normal human.For one thing, we will compare the two groups and study the role of~     thyroid function in the develoment of STAAD. For another, we will collect all the~     perioperative data of the STAAD group and study the role of thyroid function in the prognosis~     of STAAD.~   "
32129|NCT03146481|"~     The aim of this randomized, double-blinded, controlled study is to evaluate the effect of~     pre-operative oral aceclofenac on the success of the inferior alveolar nerve block with 2%~     Mepivacaine containing 100,000 Epinephrine for patients with symptomatic irreversible~     pulpitis.~   "
32130|NCT03146468|"~     This is a prospective study of the safety and efficacy of nivolumab for the treatment of~     relapsed or residual haematological malignancies after allogeneic stem cell transplantation~     (alloSCT).~      Eligible patients will receive nivolumab at a dose of 3mg/kg intravenously every 2 weeks. The~     primary objective is to evaluate the incidence, severity and treatment responsiveness of GVHD~     following nivolumab treatment post-alloSCT.~   "
32131|NCT03146455|"~     The purpose of this study was to establish the normal reference range of Thrombelastogram~     parameters in Hunan by a multicenter study, and to analyze the specificity of~     Thrombelastogram detection and the influence of gender, age and blood type on~     Thrombelastogram. The study will provide basic data and statistical basis for the~     establishment of normal reference range of Thrombelastogram in Hunan.~   "
32132|NCT03146442|"~     Adolescent obesity, negatively affecting the lives of over 18 million (34%) US adolescents,~     continues to be a major public health concern due to the increased risk of developing chronic~     diseases, including type 2 diabetes. Thus, there is a great need to develop effective,~     dietary strategies that target health outcomes, including weight management and glycemic~     control in young people. One particular strategy that is gaining scientific support includes~     the daily consumption of a protein-rich breakfast. This study will identify the potential~     role of protein at breakfast as a key component of a healthy diet for improvements in~     appetite control, satiety, and weight management to reverse the obesity epidemic and prevent~     and/or delay serious health complications in young people.~   "
32133|NCT03146429|"~     This is the re-analyzing study of observational study by Parkinson's Progression Markers~     Initiative~   "
32134|NCT03146416|"~     The primary objective of the study is to compare the safety and tolerability of subcutaneous~     (SC) and intravenous (IV) doses of evinacumab in healthy Japanese and Caucasian subjects.~   "
32135|NCT03146403|"~     The main purpose of this clinical study is to see if a maintenance dose of GEN-003 reduces~     the number of days that subjects have a genital herpes recurrence. The second purpose of the~     study is to evaluate the safety and tolerablility of a maintenance dose of GEN-003.~   "
32136|NCT03146390|"~     The Essential oils (EO) are composed by a wide diversity of products. Therefore, their~     antimicrobial activity will be related to their composition, configuration, amount and their~     possible interaction. The traditional formulation containing EO (T-EO) is a complex mixture~     of phenolic compounds combined with determinate EO: 0.092% of eucalyptol, 0.064% of thymol,~     0.06% of methyl-salicylate and y 0.042% of menthol. All of this solved in a hydroalcoholic~     vehicle containing from a 21.6% to a 26.9% of alcohol. Thus, T-EO contain ethanol, which is a~     chemical compound used in order to dissolve and stabilize the numerous substances present in~     the rinse. The concentration of ethanol present in the T-EO rinses, as previously said, is~     more than 20%. This concentration of ethanol, higher than 20%, is been found sufficient to~     dissolve the EO but insufficient to have a direct antibacterial effect. In fact, the~     manufacturer presents the alcohol contain (21.6%), among others, as an inactive ingredient in~     its formula. Over the years, the adequacy of the use of ethanol in mouthwashes, as well as~     their effects on the surfaces of composite restorations and their possible role in~     development of oropharyngeal cancer have been discussed. Although a direct cause-and-effect~     correlation between the development of oropharyngeal carcinoma and the use of alcohol-based~     rinses has not been demonstrated and probably it will never be (at least by epidemiological~     studies), it is considered desirable to eliminate ethanol from daily mouthwashes, especially~     for those patients at higher risk. Furthermore, the fact that the alcohol is present in its~     formula, have produced that some clinical practitioners do not prescribe the traditional~     formula due to the controversy of the issue. All this have lead to the development of new,~     alcohol free formulations of EO (Af-EO).~      The composition of the Af-EO is exactly the same in their active ingredients (Eucalyptol,~     Thymol, Methyl-salycilate and Menthol), but sodium fluoride has been added. Some differences~     are found in their inactive ingredients. These are based on the alcohol containing of the~     T-EO, without presence in the Af-EO and the presence of Propylene Glycol, sodium lauryl~     sulfate and sucralose in the Af-EO, without presence in the T-EO.~      In order to measure the efficacy of a mouthwash against the dental plaque two different~     concepts should be defined: the substantivity and antiplaque effect. The substantivity of an~     oral antiseptic is defined as the prolonged adherence to the oral surfaces and its slow~     release at effective doses which guarantee the persistence of the antimicrobial activity. The~     more substantivity an oral antiseptic has the better. For its study in vivo, the most popular~     models are those which analyze the effect that a single mouthwash has in a mature biofilm.~      The second aspect that should be studied from an oral antiseptic, the antiplaque effect, is~     defined as the capacity that an agent has to avoid the formation of bacterial aggregates~     (plaque) on the oral surfaces. For its study in vivo, models start from a baseline sample~     with levels of plaque near to 0 in order to assess the power of the antiseptic to reduce the~     formation of bacterial plaque (normally dental plaque) against the control. A clinical study~     of 6 months using a determinate antiplaque agent is necessary in order to tag an antiseptic~     as effective. However, in the literature, there is an established model of 4 days of plaque~     regrowing which can assess the inhibitory activity that the mouthwashes have per se;~     furthermore, it determines the relative efficacy of the different formulations being~     considered as predictable of the antiplaque effect of an antiseptic.~      In addition, another important factor in the study in vivo of an oral antiseptic is the~     necessity to conserve intact the oral biofilm at all stages: formation, recollection and~     analysis of the oral samples. This is in order not to interfere the delicate three~     dimensional structure of the oral biofilm which has been proven to be essential in the~     resistance to the effects of an external antiseptic agent. For these reasons, the study of~     the oral biofilm with the help of intraoral disks hold in specially designed apparatus~     combined with the application of the Confocal Laser Scanning Microscopy have proved to be~     very valuable at the study of the oral biofilm in its intact hydrated natural state.~      Since an alcohol free formulation of the EO have come up to the market, it seems convenient~     to compare its effects to the traditional one. Although some studies comparing the effects of~     T-EO and Af-EO have been found, none of them assessed and compared their substantivity and~     antiplaque effect in an in vivo model of structured oral biofilm. For this reason, the aim of~     the present study was to compare the in vivo antibacterial effect (immediate effect,~     substantivity and antiplaque effect) of the EO with and without alcohol in structured oral~     biofilm.~   "
32140|NCT03146338|"~     Anti-EGFR (Epidermal Growth Factor Receptor) therapies, namely cetuximab and panitumumab,~     have become standards in the management of metastatic colorectal and head and neck cancers.~     These therapies are used in daily practice, that requiring to manage their skin and digestive~     toxicities. However, anti-EGFR are also frequently responsible for hypomagnesemia often~     neglected and under-treated.~      Hypomagnesemia may manifest as asthenia, cramps, muscle weakness, mood disorders. She is~     often underestimated because they are difficult to identify and accountable by clinicians in~     the context of cancer under chemotherapy.~      There is currently no national or international recommendation on the management of~     hypomagnesaemia in oncology and medicine in general. There are, however, on the market many~     nutritional supplements rich in magnesium in the form of tablets or oral solution, in~     multiple dosages.~      These food supplements rich in magnesium are sold without proof of effectiveness. Moreover,~     the prescription of oral magnesium supplementation adds to the oncology patient an~     over-medicalization, which can be poorly tolerated at the digestive level, and responsible~     for diarrhea and a lack of compliance.~      The European Food Safety Authority (EFSA) recommends in its opinion on Dietary reference~     values for water to consume 2 liters for women and 2.5 liters for men every day, all sources~     combined (food and beverages). The drink represent 80% of the water intake, that is about 1.5~     Liter per day excluding food. However, there are multiple water marketed or distributed~     freely, with different compositions. Thus the quantity and quality of the mineral water~     consumed can influence the metabolism. Rozana® mineral water, has the double advantage of~     being the French water the most concentrated in magnesium (160 mg / L) and of being lowly~     concentrated in sulphate, responsible of the laxative power of certain waters.~      Instead of adding magnesium supplements with a poor digestive tolerance, to patients with~     metastatic cancer and often with a heavy treatment , the aim of this study is to evaluate~     whether a change in oral hydration in quantitative and qualitative terms can decrease the~     rate of hypomagnesemia in patients treated with anti-EGFR.~   "
32141|NCT03146325|"~     This study is an etiologic trial to test the hypothesis that predicts that Helicobacter~     pylori eradication in asymptomatic/mildly dyspeptic adults will result in an increase in body~     iron. The study will assign and aims to complete the follow-up of 240 subjects half of them~     assigned to a highly effective FDA approved 14-day course of a 3-1 capsule containing bismuth~     subcitrate, metronidazole and tetracycline plus omeprazole which is now OTC. We have tested~     the effectiveness of this therapy in the study population and it seems to yield almost 100%~     eradication on PP analysis. We need the best possible, near 100% eradication rate, which we~     have already obtained in a pilot, to make comparisons on ITT basis and safely conclude that H~     pylori leads to a deficit of body iron.~   "
32142|NCT03146312|"~     This is a global transcriptomics and epigenetic pilot study designed to identify changes in~     gene expression and DNA methylation patterns following the consumption of an~     MVM/phytochemical supplement in a small group of healthy subjects. We hypothesize that~     genome-wide transcriptional and epigenetic studies will elucidate the molecular mechanisms~     underlying the health benefits associated with MVM/phytochemical supplementation.~   "
32143|NCT03146299|"~     Since the introduction of total laparoscopic hysterectomy in 1989, laparoscopic gynecologic~     surgery has undergone many advances. TLH or LAVH has the advantages of faster recovery, fewer~     complications and shorter hospitalization compared to total abdominal hysterectomy.~      However, the hysterectomy for giant uterus has the difficulty of delivering the uterus out of~     the body. According to the results of TLH, LAVH and abdominal hysterectomy, TLH and LAVH show~     the postoperative complications were less frequent (3) and the postoperative recovery (4) and~     return to daily life were faster than total abdominal hysterectomy (3) even if it took longer~     operation time.~      Therefore, laparoscopic hysterectomy has many advantages over abdominal hysterectomy and~     indications are increasing. However, there has not yet been a direct comparison between TLH~     and VALH for large uterine surgery. In this study, we compared the results including the~     complications, hospitalization period and so on., in undergoing operation and post-operation~     between TLH and LAVH for the removal of giant uterus, which is predicted to be over 500 g.~   "
32144|NCT03146286|"~     The aim of the study will investigate whether impairment in the action of insulin to promote~     the use of glucose in skeletal muscle (insulin resistance) as a result of oral ingestion of a~     liquid meal rich in saturated fat is linked to reduced ability of muscles to synthesise new~     protein in response to dietary protein intake, which ultimately may compromise maintenance of~     muscle size and quality of life.~   "
32145|NCT03146273|"~     This clinical study is designed to evaluate difference in the AUC of the absorption of~     Multivitamin and minerals defined in the protocol~   "
32146|NCT03146260|"~     Azoospermia is complete absence of sperm in the ejaculate. It accounts for 10-15% of male~     infertility cases. It is classified as obstructive and non-obstructive azoospermia (NOA). NOA~     constitutes 60% of all cases of azoospermia. Testicular sperm extraction (TESE) for~     intracytoplas¬mic sperm injection (ICSI) was first introduced for treatment of obstructive~     azoospermia in 1993. Soon afterwards testicular sperm were retrieved successfully and used in~     ICSI in cases of NOA. In the NOA cases, TESE combined with ICSI has been proven to be an~     acceptable line of treatment. Microdissection TESE may have some theoretical benefits over~     conventional TESE, but uncertainty exists about its superiority. During a conventional TESE~     procedure, the testis is exposed through a small incision and one or multiple biopsies are~     taken blindly. Micro TESE was first introduced in 1999. In this technique, the tunica~     albuginea is widely opened and examination of the testicular tissue is carried out at 20-25×~     magnification under an operating microscope allowing visualization of whitish, larger and~     more opaque tubuli. The concept of this technique is that these tubuli are more likely to~     contain active spermatogenesis. also no secure clinical predictors of (SR) are demonstrated~     for both procedures.The recovery of spermatozoa is successful in only 50% of cases and~     therefore the ability to predict those patients with a high probability of achieving a~     successful sperm retrieval would be of great value in counselling the patient and his partner~     . There is no single clinical finding or investigation that can accurately predict the~     outcome of TESE.An unsuccessful sperm recovery has important emotional and financial~     implications so objective counselling based on predictive factors may offer realistic~     expectations for both the couple and physician.~   "
32147|NCT03146247|"~     This study aims to identify and describe the presence of itch active molecules in psoriasis~     and response to treatment with apremilast. This data will be complemented by~     immunohistochemical data determining nerve ending density and neuropeptide concentrations~     before and during treatment and correlated with patient reported outcome. It is important to~     underscore that itch may interfere with various aspects of patient functioning, emotions and~     social status and should therefore be adequately addressed while treating patients with~     psoriasis~   "
32148|NCT03146234|"~     This study is designed to determine the safety and efficacy of CAR-GPC3 T cells in patients~     with relapsed or refractory hepatocellular carcinoma. Single or multiple doses of~     GPC3-targeted CAR T cells will be given to subjects with unmet medical needs for which there~     are no effective therapies known at this time.~   "
32149|NCT03146221|"~     The initial hypothesis of this work is that the genesis and the evolution of the atheromatous~     plaque are partly controlled at the molecular level and in particular by the microRNAs~     through their role as regulator of the genes.~      The study of the tissue and serum profile over time of specific microRNAs involved in the~     regulation of atheromatous plaque correlated with clinical data and restenosis imaging will~     allow to define biological markers of restenosis in the patient with an arteritis of the~     lower limbs .~      This study is a pioneer in the field and it would be imprudent to conclude that a biomarker~     would be used clinically at the end of this work alone. Nevertheless this study will make a~     major advance in this topic, in vivo intervention studies with inhibition or over-expression~     of microRNA will obviously be necessary to confirm the use of these as biomarkers of~     arteritis of the lower limbs.~      Regular assay of reliable biomarkers in arterial patients will ultimately suggest early~     management to best adapt surgical and medical treatment.~   "
32150|NCT03146208|"~     Coronary artery disease is a contraction of the coronary arteries that prevent adequate blood~     supply to the heart muscle is called CAD. Usually caused by atherosclerosis, it may be~     advanced to the point where the heart muscle is injured due to lack of blood supply. Such~     damage may result in infarction, arrhythmias, and heart failure(1,2).~      Telomeres are short in circulating leucocytes in patients with coronary artery disease but~     the precise mechanism is not well-known (3).~      Telomere and telomerase are affected by cytomegalovirus (CMV) infection due to its effect on~     increasing the number of highly differentiated T cells that are characterized by shorter~     telomere length (TL) and lowered telomerase activity (TA). Both genetic and environmental~     factors have been connected with individual distinction in TL.Cardiovascular risk factors~     such as smoking, diabetes mellitus, hypertension, obesity, and stress have been considered to~     upsurge inflammation, oxidative stress, therefore accelerating TL shortening (1,2)~      It has also been observed that telomere loss in type 2 diabetic patients contributes to~     oxidative stress and endoplasmic reticulum stress while telomere shortening has also been~     proposed that it can serve as an independent risk factor of T2DM and it can measure disease~     progression(4).~      Moreover, telomeric length in peripheral blood mononuclear cells (PBMCs) is associated with~     the duration of disease and good glycemic control seems to be protective for telomeric loss~     (5).~      Growth differentiation factor-15 (GDF-15) is a member of the transforming growth factor~     (TGF)-β superfamily. GDF-15, recently identified as one of the new cardioprotective~     cytokines. It is highly expressed in cardiomyocytes, adipocytes, macrophages, endothelial~     cells, and vascular smooth muscle cells in normal and pathological condition. GDF-15~     increases during tissue injury and inflammatory states and is associated with cardiometabolic~     risk(6).~      Dipeptidyl peptidase inhibitors (DPP4 -I) are called gliptins which increase the incretin~     levels and therefore prolong the post-prandial insulin action(7).~      Diana et al reported that In type 2 diabetic patients, leukocyte telomere was significantly~     shorter than control groups and was significantly elongated after intervention by~     sitagliptin(8).~      The common feature of all risk factors of CAD and T2DM imbalance between pro- and~     anti-oxidative factors in the organism with an increased production of reactive oxygen~     species (ROS).Nuclear factor erythroid-derived factor 2-related factor 2(Nrf2) is a family of~     transcription factors which plays an important role in protection against CVD and DM by~     regulating antioxidant enzymes in cells after ROS exposure (9).~      In our study, we will propose a model, which would provide the basis to establish a marker~     for chronic reactivation of CMV and shed more light into the pathophysiology of CMV infection~     in patients with CAD in relation to GDF-15 and NrF2 and their implications on disease~     progression. Ultimately, this would then enable us to identify patients at risk and develop~     novel strategies for future treatment and prevention of heart diseases in our country. In~     light of our project research, the question arises whether telomere length could represent a~     marker of chronic CMV reactivation and uncertainty their length will be modified by the~     effect of DPP-4 or not?~   "
32151|NCT03146195|"~     Female pelvic organ prolapse (FPOP) is one of the main diseases affecting the quality of life~     of middle aged and elderly women in non-neoplastic diseases. An aging population makes the~     incidence of this disease to increase year by year. Surgical operation is the main treatment.~     While the recurrence rate of classic repair surgery is high, the method of patch implantation~     reinforces the supporting force, which significantly reduce the recurrence rate. However,~     this method is costly and is associated with complications which may trigger new symptoms. As~     such, there is still no perfect surgical method. The main reason for this is that the~     assessment method of pelvic defects is crude and indirect, which results in the diagnosis of~     FPOP only representing external problems whereas, inner defected parts are not properly~     assessed. In recent years, research with the use of 2D and 3D MRI reconstructions on the anus~     levator muscle and ligament has become a hot topic. It found that the characteristic of the~     high resolution of soft tissue in the magnetic resonance imaging (MRI) has a big advantage in~     pelvic floor study.The investigators commenced the study of 3D reconstruction technology~     based on the MRI datasets in 2009. The investigators have mastered the most common, key~     technologies of MRI three-dimensional reconstruction. The investigators have done research~     targeted on the reconstruction methods of the normal pelvis, viscera, ligaments, pelvic floor~     muscles. This project is aimed at 3D reconstruction of the whole pelvic base on static and~     dynamic MRI images from FPOP patients, and establish the corresponding space coordinates~     assessment system to do location and quantitative research of the pelvic viscera and its~     support structure, thus providing a FPOP diagnosis platform that is more precise, direct and~     comprehensive.~   "
32152|NCT03146182|"~     The purpose of this study is to determine the efficacy of C-reactive protein and~     procalcitonin based guidelines versus standard of care to reduce duration of antibiotic~     exposure in patients hospitalized with community acquired pneumonia.~   "
32153|NCT03146169|"~     In recent years, Hong Kong has been undergoing rapid changes with macro social and economic~     trends. The increasingly complex and diverse family structure contribute to concerns~     regarding the well-being of families in Hong Kong, including their health, happiness and~     harmony (FAMILY 3Hs). Family life and health education should be strengthened to meet the~     increasing needs of promoting healthy active lifestyle among Hong Kong families. In this~     connection, the FAMILY Project initiates the Fitter Families Project (FFP) with a focus on~     FAMILY Holistic Health, will be conducted in order to increase the awareness of the~     importance of FAMILY 3Hs. FFP is a community-based research project with 3 main components -~     train-the-trainer program, community-based family interventions and public education events.~     It is expected that trainees from the train-the-trainer program will acquire adequate skills~     to organize community-based health education programs effectively. Participants of the~     community-based family interventions will gain knowledge on family holistic health and live a~     healthy active lifestyle. Attendees of the public education events will become more aware of~     the importance of FAMILY 3Hs.~   "
32154|NCT03146156|"~     The objective of this proposal is to break the vicious cycle of obesity/metabolic dysfunction~     during pregnancy. Lifestyle interventions in obese women during pregnancy have had limited~     success in improving maternal or offspring short and long-term metabolic health. We propose~     that lifestyle interventions need to be initiated prior to conception in overweight and obese~     women (henceforth referred to as obese) in order to first improve maternal metabolism.~     Lifestyle interventions will take place in the greater Cleveland recreational facilities.~     Metabolic evaluations will be conducted in the Clinical Research Units of the Case Western~     Reserve Clinical Translational Science Center (CTSC). We hypothesize this will result in~     decreased fetal adiposity and improved metabolic function in the offspring.~   "
32155|NCT03146143|"~     study will assess the effect the ultrafiltration after pediatric congenital heart surgery on~     cardiopulmonary bypass. patients will be divided into two groups. first group will receive~     ultrafiltration and the second group will be control group without filtration.~      we will assess extravascular lung water by lung ultrasound, arterial oxygen tension and~     duration of ventilation.~   "
32156|NCT03146130|"~     Impulse control disorders encountered in Parkinson's disease (PD) are induced by dopaminergic~     medications and their frequency is estimated to be nearly 20%, mainly under dopaminergic~     agonists (AD). They constitute a major public health issue due to their sometimes dramatic~     socio-occupational and judicial consequences. Most often the therapeutic strategy is to~     reduce or even stop AD, which can lead to withdrawal symptoms, apathy or aggravation of motor~     signs.~      N-acetylcysteine (NAC) may have an interest in the treatment of ICD. This molecule reduces~     craving in addictions by substance abuse, but also in behavioral addictions, with as a~     potential mechanism a reduction in levels of plasma alphasynuclein.~      The main objective of this randomized, double-blind, placebo-controlled, multicenter~     controlled trial is to demonstrate that a 10-week NAC add-on treatment, compared to placebo,~     improves the behavioral addictions of Moderate in the MP. The main endpoint will be the~     variation of the subdivision of the hyperdopaminergic behaviors of the Ardouin Parkinson's~     Disease Behavioral Assessment (ECMP) scale between the baseline and after 10 weeks of~     treatment.~   "
32157|NCT03146117|"~     The overall goal of this project is to investigate the diagnostic performance of integrated~     F-18 fluorodeoxyglucose-positron emission tomography (FDG-PET) and Dual Energy CT (DECT)~     imaging in determining the thoracic nodal status of small-cell lung cancer (SCLC) and~     non-small-cell lung cancer (NSCLC), and its impact on target volume delineation for image~     guided radiation therapy (IGRT) planning.~   "
32158|NCT03146104|"~     Consent will be taken from the relatives and the patient will be taken to the operating room.~     Inside the operation theatre patient will be shifted to operating table and standard monitors~     will be attached. The patient will then be given induction agent to make him/her unconscious~     and unaware of the surrounding and muscle relaxant to prevent movement will be administered.~     He/she will be intubated with appropriate size tube to maintain airway. In order to maintain~     anesthesia he/ she will be given either of inhalational or intravenous anesthetic throughout~     the surgery. Intracranial pressure will be measured using venflon needle as soon as burr hole~     is created in the skull. Throughout the surgery patients vital parameters will be monitored~     and appropriate treatment will be given in case if the vitals are not stable.~   "
32159|NCT03146091|"~     Uncomplicated sigmoid diverticulitis is a common disease in Western countries. Traditional~     management includes inpatient administration of either oral or intravenous antibiotics with~     resumption of oral intake as symptoms improve. Recent literature has however questioned both~     inpatient and antibiotic treatment. Indeed, both inpatient and antibiotic treatment are~     associated with non-negligible risks to patients. The aim of this trial is to assess the~     feasibility of a randomized controlled trial designed to determine whether nonantibiotic~     treatment of uncomplicated diverticulitis is safe in the outpatient setting.~   "
32160|NCT03146078|"~     The overall goal of this project funded by the Foundation Fighting Blindness is to~     characterize the natural history of disease progression in patients with USH2A related~     retinal degeneration associated with congenital hearing loss (Usher syndrome type 2a) or~     non-syndromic retinitis pigmentosa (RP39).~   "
32161|NCT03146065|"~     The purpose of this study is to determine the safety, tolerability and pharmacokinetics of~     escalating single and multiple intravenous (IV) infusions and subcutaneous (SC) injections of~     PF-06730512 in healthy subjects.~   "
32162|NCT03146052|"~     We aimed to compare the efficacy for bowel cleansing of a split-dose regimen with a low~     morning dose of PEG solution (Asymmetric; 25% of the dose is given on the day of the~     procedure and 75% of the dose is given on the day before) with the standard split-dose~     regimen in patients undergoing screening and surveillance colonoscopy using a low volume~     bowel preparation (2L PEG-citrate-simethicone plus Bisacodyl). We enrolled consecutive~     outpatients undergoing screening and surveillance colonoscopy in a randomized, single-blind,~     non-inferiority clinical trial. Patients were randomly assigned to: group A, asymmetric split~     dose regimen (1,5 L of PEG + bisacodyl the day before and 0,5 L 4 hours before colonoscopy);~     group B, symmetric split dose regimen (1 L of PEG + bisacodyl the day before and 1 L 5 hours~     before colonoscopy). Primary endpoint was the proportion of adequate bowel cleansing.~     Moreover, all patients filled in a nurse-administered questionnaire assessing compliance,~     tolerability and safety of bowel preparation.~   "
32163|NCT03146039|"~     The purpose of this study is to find out whether patients with cervical cancer treated with~     about a new radiation technique called stereotactic body radiotherapy (SBRT) have less~     stress and anxiety compared to standard brachytherapy radiation. With standard brachytherapy~     radiation, metal hardware is placed through the vagina and into the uterus, which can cause~     pain and discomfort. SBRT is a new radiation technique that is non-invasive and does not~     require the insertion of any metal hardware.~   "
32164|NCT03146026|"~     The purpose of this study was to examine the impact of 12 weeks of combined exercise training~     (CET) on arterial stiffness, endothelial function, inflammatory markers, insulin resistance,~     and body composition in obese adolescent girls. Thirty obese adolescent girls participated in~     this study. The girls were randomly divided into CET group (n=15) and control group (n=15).~     The CET group performed concurrent resistance training followed by aerobic training at 40-70%~     of the heart rate reserves (HRR) 3 days/week for 12 weeks. Plasma nitric oxide, endothelin-1,~     C-reactive protein, arterial stiffness, homeostasis model assessment of insulin resistance~     (HOMA-IR), glucose, insulin, and the adiponectin/leptin ratio were measured before and after~     the 12-weeks study.~   "
32165|NCT03146013|"~     The purpose of this study is to assess the validity and reproducibility of the MP Diagnostics~     HTLV Blot 2.4 in blood specimens testing repeat reactive (RR) on the first FDA licensed~     screening assay (Abbott Prism) and non-reactive (NR) on the second FDA licensed screening~     assay (Avioq ELISA).~   "
32166|NCT03146000|"~     Postpartum perineal pain is a very common complaint. It can have negative consequences for~     mother and child including disability in daily functioning for the mother; for example, it~     can interfere in taking care of her infant and in breastfeeding. Early pain management is~     thus relevant to provide relief and prevent chronicity.~      Perineal pain is particularly common following childbirth. Macarthur 2004, in a prospective~     cohort study involving 447 women in Canada, reported an incidence of perineal pain, in the~     first day after birth, of 75% in women with an intact perineum~   "
32167|NCT03145987|"~     The increase in life expectancy is associated with a gradual aging of the population so~     creating new needs arising from this new situation. Memory ability declines with age and~     memory deficits are regarded as an initial symptom of dementia of Alzheimer's Disease (AD)~     type, one of the most prevalent cognitive disorders in older people. States and scientific~     community have been called to find preventive strategies acting against the consequent~     physiological cognitive decline with the aim to attenuate the increase of dementia. Numerous~     studies have shown that polyphenolic compounds derived from multiple dietary sources, and~     more specifically the polyphenolic compounds found in grapes (GP), are able to attenuate the~     cognitive impairment and in reducing neuropathological lesions in the brain in experimental~     animal models for the study of Alzheimer's Disease (AD) .~      In recent years, several in vivo studies have shown that oral administration of polyphenols~     from grapes improves antioxidant status in the brain and prevents neuronal damage induced by~     free radicals. The intake of proanthocyanidins, especially in the monomeric form, showed to~     produce an improvement of cognitive function in an Alzheimer's disorder animal model.~      A randomized, double-blind, placebo-controlled clinical trial was designed by the~     investigators with the aim to evaluate potential beneficial effects of a Vitis vinifera-based~     food supplement on cognitive functioning and neuropsychological status in healthy older~     adults aging 55-75 years.~      For the enrollment, mental status was evaluated through the Mini-Mental State Exam, a test~     able to provide quickly a screen of orientation, providing a rapid screen of recall,~     language, orientation, registration, attention and calculation. 111 subjects were recruited~     and, after obtaining the informed consent, successively randomly divided in two groups: Group~     1, N = 57 to be treated for 12 weeks with Vitis vinifera extract (verum 250 mg/day); Group 2,~     N = 54 to be treated for 12 weeks with placebo. Cognitive functioning and neuropsychological~     status were evaluated at the beginning (before treatment) and a the end of treatment by using~     Mini Mental State Examination (MMSE), Beck Depression Inventory (BDI), Hamilton Anxiety~     Rating Scale (HARS) and Repeatable Battery for the Assessment of Neuropsychological Status.~   "
32203|NCT03145519|"~     A prospective, single-center, open-label, randomized controlled trial to demonstrate the~     safety and efficacy of the OptiVein IV Catheter in the pediatric population. The study~     hypothesis is that OptiVein IV Catheter use will be superior to the control in successful~     venous access after first attempt.~   "
32169|NCT03145961|"~     c-TRAK TN is a multi-centre phase II study, consisting of a circulating tumour DNA (ctDNA)~     screening component and a therapeutic component. c-TRAK TN aims to assess whether ctDNA~     screening can be used to detect residual disease following patients standard primary~     treatment for triple negative breast cancer, and will assess the safety and activity of the~     investigational medicinal product pembrolizumab.~   "
32170|NCT03145948|"~     This is a study to assess the pharmacokinetics, safety and tolerability of multiple ascending~     oral doses of ABBV-553 in healthy volunteers and the pharmacokinetics, safety, tolerability~     and efficacy of multiple ascending oral doses of ABBV-553 in participants with psoriasis~     under non-fasting conditions.~   "
32171|NCT03145935|"~     Fluid overload increases morbidity and mortality of pediatrics patients in intensive care~     unit (ICU). It could be interesting to predict the decrease in stroke volume when diuretics~     are prescribed. Nevertheless, no test predict a decrease of stroke volume in a context of a~     diuretics induced depletion. Abdominal compression (AC) coupled with echocardiographic~     measurement of the stroke volume can predict fluid responsiveness and is a good tool to~     assess preload dependency. Another point is that during depletion refilling can occur. We aim~     to assess the diagnostic accuracy of abdominal compression to predict a decrease of the~     stroke volume of 15 % during diuretic-induced depletion of 10 ml/kg of diuresis. Secondary~     outcome will assess the hemoconcentration during depletion to diagnose a decrease of stroke~     volume during diuretic induced depletion~   "
32172|NCT03145922|"~     Sarcoidosis is a multi-system granulomatous disorder that is triggered and influenced by~     gene-environment interactions. Although sarcoidosis predominantly affects the lungs in most~     cases, the clinical disease course is highly variable and any organ can be affected leading~     to end organ damage despite currently available therapeutics that unfortunately also have~     numerous and potentially devastating side effects. The environmental triggers of sarcoidosis~     are unknown but several occupational, environmental and infectious agents have been~     associated with sarcoidosis in susceptible hosts. Exposure to these triggers result in~     inflammation, characterized by activation of CD4+ T-cells, cytokine production, subsequent~     recruitment of other immune cells, and granuloma formation. Although several genetic markers~     have been associated with sarcoidosis, none fully explain individual susceptibility or~     clinical course variability, strongly implicating the environment and epigenetics. We have~     the ability to generate a map of the epigenetic histone modifications in immune cells via~     Chromatin Immuno-Precipitation coupled with next generation sequencing (ChIP-seq) and a map~     of transcriptome profiles via RNA-seq. The availability of histone and transcriptional~     signatures defining T cell activity in sarcoidosis will help identify the specific molecular~     programs affected by disease processes and can become the basis for future discovery of novel~     biomarker diagnostics in a clinical setting.~   "
32173|NCT03145909|"~     This is an open-label, Phase I, dose-escalation study to determine the maximum tolerated dose~     (MTD) and the recommended phase two dose (RPTD), and to assess the safety, preliminary~     efficacy, and pharmacokinetic (PK) profile of ABBV-176 for participants with advanced solid~     tumors likely to express Prolactin Receptor (PRLR). The study will consist of 2 cohorts: Dose~     Escalation and Expanded Recommended Phase 2 Dose.~   "
32174|NCT03145896|"~     Crohn's disease (CD) and ulcerative colitis (UC) are chronic gastrointestinal diseases~     characterized by relapsing and remitting inflammation of the intestines Anemia may often~     complicate the course of inflammatory bowel disease (IBD). The cause of anemia in IBD is~     multifactorial In the chronically ill patients, it has been described that the mechanism~     underlying anemia involves hepcidin.A potential mechanism underlying anemia during an chronic~     disease is suggested by recent data demonstrating a hepcidin lowering effect of vitamin D~   "
32175|NCT03145883|"~     This pilot study will use an unmasked, parallel group, randomized design. Thirty adult~     overweight or obese subjects with mild-moderate persistent asthma will be randomly assigned~     to one of two groups: 12-weeks of home-based moderate intensity aerobic exercise versus no~     intervention. The study will include 2 clinic visits and 12 telephone calls. Exercise testing~     to assess physical fitness levels will occur during visits 1 and 2. Blood sampling for~     biomarkers, inflammatory markers, and other assessments will be done.~   "
32176|NCT03145870|"~     Malignant hemopathies, such as solid cancers, increase the risk of venous and arterial~     thromboembolic events. The incidence of symptomatic venous thromboembolic events is~     particularly high in myeloma, linked to the usual risk factors for venous thromboembolic~     disease, biological risk factors specific to myeloma, and especially to its treatments.~      The prevalence of asymptomatic venous thromboembolic events and arterial events are not known~     to date and remain important data for planning a possible randomized study to determine the~     most suitable thromboprophylaxis in these patients.~   "
32177|NCT03145857|"~     A [68]Ga-HA-DOTATATE PET/CT scan is a nuclear medicine test used to create pictures of the~     whole body that will show where somatostatin receptors are found, including on tumours.~     Somatostatin receptors are found on most neuroendocrine tumours (NETs), and some other types~     of tumours. Currently at the Cross Cancer Institute, most patients with suspected~     somatostatin positive tumours (e.g. NETs) have an Octreoscan™. A scientific study has shown~     that a scan with a similar product ([68]Ga-DOTATATE) is more accurate than an Octreoscan™.~     This study will look at [68]Ga-HA-DOTATATE scans, a product virtually identical to~     [68]Ga-DOTATATE.~      The purpose of this study is to: 1) demonstrate the safety of [68]Ga-HA-DOTATATE; and 2)~     confirm that [68]Ga-HA-DOTATATE is effective at diagnosing somatostatin positive tumours.~   "
32178|NCT03145844|"~     This study is a retrospective study conducted at 36 sites. Planned target patient number is~     1000.~   "
32179|NCT03145831|"~     This study is a multi-center, open-label safety study assessing long-term somavaratan~     administration.~   "
32180|NCT03145818|"~     Veteran-Directed Home and Community Based Services (VD-HCBS) is focused on preserving~     Veteran's independence and the VA Office of Geriatrics and Extended Care is planning an~     expansion of VD-HCBS to 90 additional VA Medical Centers over the next 3 years. This proposal~     seeks to evaluate the VD-HCBS expansion to capture comprehensive information on the impact of~     VD-HCBS on Veterans' and Caregivers' outcomes, as well as, to identify how the program was~     implemented.~   "
32498|NCT03141645|"~     This study is designed to examine the incidence of postoperative nausea and vomiting during~     24 hours after elective laparoscopic cholecystectomy in patients receiving preoperative~     intravenous fluid loading (group F), ondansetron (group O) and receiving neither fluid nor~     ondansetron or control group (group C).~   "
32181|NCT03145805|"~     Bupivacaine is a local anesthetic commonly used to manage postoperative pain. Liver resection~     patients typically have an epidural catheter placed preoperatively through which they receive~     a continuous infusion of bupivacaine and hydromorphone for up to 5 days postoperatively. The~     liver metabolizes bupivacaine, and produces proteins that bind with bupivacaine to take it~     out of circulation and thereby reduce its toxicity. Because a portion of the liver is being~     removed due to pre-existing liver disease, investigators hypothesize that liver resection~     patients have an impaired ability to clear bupivacaine from circulation that may increase~     their susceptibility to bupivacaine toxicity. To assess this, investigators will measure free~     and bound bupivacaine in liver resection patients postoperatively to determine whether~     bupivacaine reaches toxic levels. Investigators will also quantify binding protein levels to~     determine if these levels are reduced after surgery, which could contribute to the elevated~     bupivacaine levels in these patients. Finally, investigators will monitor patients for signs~     and symptoms associated with bupivacaine toxicity.~   "
32182|NCT03145792|"~     This randomized controlled trial examines the efficacy of two behavioral therapies. Seeking~     Safety, which addresses co-occurring problem gambling (PG) and posttraumatic stress disorder~     (PTSD), is being compared to Cognitive-Behavioral Therapy for PG, which addresses only PG.~     Both models are delivered via telehealth.~   "
32183|NCT03145779|"~     Cerebrovascular events, such as stroke, are a devastating complication of Fabry disease that~     results in part from storage of complex lipids in both large and small vessels. Understanding~     how the genotype influences the phenotype or clinical presentation can help us understand~     which patients are at risk for the complications of Fabry disease. This study aims to follow~     the natural history of this disease will help us understand and predict long-term outcomes~     for patients.~   "
32184|NCT03145766|"~     This multicenter, observer-blind, controlled, randomized, Phase II study was designed to~     evaluate different formulations of the Purified Vero Rabies Cell vaccine VRVg.~   "
32185|NCT03145753|"~     Objectives: A targeted HIV testing strategy (TTS) through an HIV risk of exposure and~     indicator conditions (RE&IC) questionnaire resulted in same rate of new HIV infection~     diagnosis (NHID), coverage and even reduced costs compared with a universal non targeted (Non~     TSS) HIV testing strategy in a prior study (DRIVE 01). To compare number of New HIV/HCV~     Infection Diagnoses (NHID HIV/HCV) and costs two HIV/HCV testing programs in the Primary~     Health Care: an educational and support only initiative to enhance HIV /HCV testing (EDSUP)~     or EDSUP plus a resourced external program (DRIVE 03).~      Methodology: Prospective, randomized 1:1, clustered, crossover study, in one Health Care Area~     of Madrid, Spain, comparing the implementation of two HIV testing programs, EDSUP only vs.~     EDSUP plus DRIVE 03 program in 4 Primary Care Centers (PCC´s). People randomized to EDSUP~     plus DRIVE 03 program, non HIV infected, between 18-65 years, attending to any of the 4~     PCC´s, not previously included in the study will be offered to participate. HIV testing~     program will be evaluated by measuring absolute number of new diagnosed infections (NDI)~     HIV/HCV and costs. Other outcomes considered will be people assigned and offered to~     participate, number of HIV tests performed, coverage (HIV /HCV tests/assigned population~     ratio), and rate of NDI HIV/HCV per ‰ tests performed. Six months prior to randomization main~     outcome variables will be recorded in the 4 PPC´s. Before randomization, EDSUP will be~     equally implemented in the 4 PCC´s. After randomization, first six months, DRIVE 03 program~     will be implemented in 2 PCC´s and in the other 2 observation of interest variables will be~     conducted. After first 6 month study period, PCC´s will be crossover to the opposite arm of~     randomization. DRIVE 03 program will offer rapid HIV tests, and testing staff to conduct all~     study procedures. For NDI HIV/HCV, molecular epidemiology, delayed diagnosis, retention in~     care, HIV/HCV treatment and control/eradication will be also monitored.~   "
32186|NCT03145740|"~     This study is a randomized controlled trial (RCT). Patients after severe acquired brain~     injury (ABI) were randomised in addition to the individual daily rehabilitation program to~     intensive Facial Oral Tract Therapy (F.O.T.T.®) (intervention group) or unspecific treatment:~     washing face, brushing teeth, without facilitating swallowing (control group).~      The duration of the intervention period was 15 working days (3 weeks). The intervention in~     both groups was twice a day.~   "
32187|NCT03145727|"~     Chemotherapy induces nausea and vomit for some large patients. But, some chemotherapy~     protocol has a high indices of the incidence as observed in a combination of Anthracycline~     and Cyclophosphamide (AC). To prevent this symptoms, some medication can be used as~     Ondansetron. By other hands, the traditional acupuncture on Chinese Medicine have been used a~     PC6 point to avoid nausea and vomit. More recently, a transcutaneous electric nerve~     stimulation (TENS) also has been used for this application. Our study will test the TENS~     applied on PC6 point with two different frequencies (high and low) to evaluated the nausea~     and vomit inhibition effects.~   "
32188|NCT03145714|"~     Postoperative Cognitive Dysfunction (POCD), is a subtle decline in cognitive function~     characterized by impairment of memory and reduced ability to concentrate in elderly patients~     exposed to general anaesthesia. This prospective study aims to compare incidence and severity~     of POCD in two groups of patients. Group P receiving Intravenous Propofol and Inhalational~     anesthetic Sevoflurane. Group D receiving Intravenous Dexmedetomidine and Inhalational~     anesthetic Sevoflurane, Neuropsychological Test will be performed 24 hours before surgery and~     on postoperative day 3 and day 7.~   "
32189|NCT03145701|"~     The purpose of this study is to use a wire with a Doppler tip to measure blood flow in~     vessels in the brain and determine hemodynamic factors associated with treatment success or~     failure. Many neurological diseases cause abnormal blood flow in the brain in specific~     vessels. The special wire used in this study is place into brain blood vessels during~     standard of care procedure to treat such diseases, and blood flow parameters (such as~     velocity and pressure) are measured to gain better understanding of these neurological~     diseases.~   "
32190|NCT03145688|"~     The purpose of this study is to examine physical activity habit formation in parents and if~     this can increase moderate to vigorous physical activity behavior in their children over six~     months. The Primary Research Question is:~      Does the habit formation condition result in increased moderate-vigorous intensity physical~     activity of the child compared to the control (education) and education + planning conditions~     at six months? Hypothesis: Child physical activity will be higher for the habit formation~     condition in comparison to the more standard physical activity education and planning~     conditions at six months.~   "
32191|NCT03145675|"~     The OPTIENOX-PCI is a randomized study, which is designed to assess the anticoagulation~     profile of different dose regimens of enoxaparin, i.e., 0.5 mg/kg, 0.75 mg/kg, and 0.5 mg/kg~     with additional 0.25 mg/kg, in about 120 patients who plan to undergo elective trans-radial~     coronary angiography with or without subsequent PCI.~   "
32495|NCT03141684|"~     This phase II trial studies how well atezolizumab works in treating patients with alveolar~     soft part sarcoma that has not been treated, has spread from where it started to other places~     in the body and cannot be removed by surgery. Monoclonal antibodies, such as atezolizumab,~     may allow the immune system cells to find and kill the tumor cells.~   "
32192|NCT03145662|"~     Patients suspected of having AV access stenosis will be referred to the Division of Vascular~     and Endovascular Surgery by the dialysis center. Patients with signs of AV access failure who~     are found to have significant stenosis (more than 50%) at the venous end of the anastomosis~     will then be randomized to either high pressure balloon (Conquest) or to a cutting balloon~     (Boston scientific Balloon). Angiograms will then be performed before and after intervention.~   "
32193|NCT03145649|"~     Background: Breastfeeding has been associated with attenuated risk of obesity and type 2~     diabetes in children born to women with diabetes. However, breast milk (BM) components~     responsible for the protective effects remain to be unveiled.~      Objective: To evaluate the hormone concentrations in BM of women with gestational diabetes~     mellitus (GDM) and their influence on early infant growth.~      Design: The investigators followed nulliparous women with and without GDM and their breastfed~     term singletons. Women diagnosed with GDM received dietary therapy or insulin injection to~     maintain euglycemia during pregnancy. Hormone concentrations in BM (i.e., adiponectin,~     leptin, insulin, and ghrelin) were tested and infant growth was evaluated on days 3, 42 and~     90. The investigators compared the hormone concentrations between the GDM and healthy groups,~     and tested the associations of hormone concentrations with maternal factors (i.e., BMI,~     plasma glucose concentration, gestational age, and delivery mode) and early infant growth.~      Hypothesis: Hormone concentrations in BM could be determined by multiple maternal factors,~     including metabolic and obstetrical factors. GDM should be a significant influencing factor~     for hormone concentrations in BM.~   "
32194|NCT03145636|"~     This is a five-year, single arm, multi-center trial to evaluate the long-term safety and~     efficacy of the Maestro Rechargeable System in treating obesity. The study will include an~     observational arm and a randomized sub-study.~   "
32195|NCT03145623|"~     Retrospective Efficacy and Safety Study With Elbasvir (EBR) 50 mg/Grazoprevir (GZR) 100 mg in~     Hepatitis C Virus (HCV)-infected Patients With Chronic Kidney Disease (CKD) Stage 4-5 During~     the French Temporary Authorization for Use (ATU) Program: Data From Real-life~   "
32196|NCT03145610|"~     The aim of this study was to evaluate the influence of a triclosan-containing toothpaste in~     the profile of osteo-immunoinflammatory mediators in the peri-implant crevicular fluid (PICF)~     and in the clinical parameters during the progression of experimental peri-implant mucositis.~   "
32197|NCT03145597|"~     The aims of this clinical study are:~      To evaluate the clinical performance between indirect composite and ceramic laminate veneers:~      Main interests are:~        -  colour stability of the restoration (digital measurement in follow up)~        -  failure mode of the restoration~        -  wear of the restoration and antagonist~      Hypothesis:~        -  The colour stability of indirect composite restorations will not be different from the~          ceramic restorations.~        -  The indirect composite restorations will not be more prone to failure than the ceramic~          restorations.~        -  Antagonist wear and restorative material wear will be similar for both ceramic and~          composite.~      Material and Methods The laminates will be fabricated according to a specified protocol. In~     order to avoid possible noticeable differences in case of distinct levels of possible~     discoloration, a modified split mouth design is employed where the central incisors and the~     symmetric other teeth receive the same type of restoration. Randomization is based on the~     paired teeth and it is performed using the flip of a coin for the choice of material.~     Evaluation will be performed at baseline and at follow-up visits annually up to 2 years.~   "
32198|NCT03145584|"~     Pain following total knee arthroplasty (TKA) is associated with delayed recovery, impaired~     mobility, increased morbidity, longer hospital stay and greater cost. Adductor canal block~     has recently been shown to improve the pain control of patients following TKA. It is not~     known whether a single shot technique or a continuous catheter-based infusion technique~     provides optimal analgesia. The investigators hypothesize that a continuous technique would~     provide better analgesia and permit patients to achieve objective measures of recovery~     following TKA than a single shot technique.~   "
32199|NCT03145571|"~     To validate a model of Continuity of Midwifery Care implemented in the region of Nabuls and~     Jericho in Palestine in 2013, register data from the Palestinian Ministry of Health will be~     analyzed for the following indicators related to usage and quality.~      Changes in these variables before and after the implementation will be compared between the~     16 clinics where the model was implemented and all comparable clinics in the region.~   "
32200|NCT03145558|"~     An open label randomized study to compare TATE versus TACE in patients with intermediate~     stage Hepatocellular carcinoma who are not suitable for surgical resection or radiofrequency~     ablation. The primary endpoint is Progression Free Survival. Secondary endpoints including CR~     rate, Time to embolization failure, Duration of CR, OS, ORR, local control rate, time to~     local recurrence and duration to local recurrence. The study treatment is to compare~     Tirapazamine versus doxorubicin when combined with trans-arterial embolization. Study plans~     to enroll 134 patients in 1:1 randomization for TATE or TACE. MRI will be used to assess~     efficacy using a central radiological review for the final analysis.~   "
32201|NCT03145545|"~     The primary objective of this protocol is to expand access for patients who lack a fully HLA~     (Human leukocyte antigen) matched sibling donor, and who are candidates for allogeneic~     hematopoietic stem cell transplant (HSCT). These patients have a serious or immediately~     life-threatening disease for which HSCT is indicated. These patients are not eligible for~     other Children's Hospital of Philadelphia Institutional Review Board (IRB) approved protocols~     that utilize CliniMACs technology for T depletion.~   "
32202|NCT03145532|"~     Hemiplegia occurs when the function of motor areas in the brain become impaired,~     predominantly unilaterally, during perinatal development. Children with hemiplegia show~     impairments in motor control of the affected side of the body. Impairments in use of the~     upper extremity are common, and lead to functional disability throughout the lifespan of a~     person with hemiplegia. Upper extremity impairments can severely affect a person's ability to~     carry out activities of daily living.~      The goal of this study at Blythedale Children's Hospital is to test the efficacy of~     transcranial direct current stimulation (tDCS) and robotic upper extremity therapy in~     improving upper extremity function in children with unilateral cerebral palsy. This study~     will test the hypothesis that physical rehabilitation, provided by repetitive arm movements~     guided by a robot, will improve upper extremity function in children with hemiplegia, and~     that this improvement can be enhanced by transcranial direct current stimulation of motor~     cortex immediately before robotic training.~   "
32204|NCT03145506|"~     Freshly excised or freshly frozen tissue for Raman analysis will be obtained from a~     dermatology practice affiliated with UMCB. In the course of the routine removal of benign or~     malignant tumors in the office, skin cancer surgeons routinely check frozen sections to~     ensure adequate margins are obtained. Consent will be obtained from patients to provide~     freshly excised or freshly frozen leftover tissue obtained during Mohs surgery to be~     discarded after histological diagnosis. Freshly excised tissue will be measured at the time~     of excision before processing, while the freshly frozen tissue samples will be stored in a~     freezer at the Mohs clinic and transferred to the UT- Austin campus for spectroscopic~     analysis.~   "
32205|NCT03145493|"~     Problem Suction drains during TKA present certain costs to the health system and requires~     additional nursing care. There is no clear evidence that supports their use, and no studies~     so far have compared blood loss in patients with or without drains when TA is administered~     during TKA.~      Hypothesis During total knee arthroplasty, the postoperative blood loss, measured by~     hemoglobin level, will be lower when no drains are used.~      Method~        -  Randomized controlled trial~        -  Monocentric, 3 surgeons~        -  Randomisation by sealed envelopes~   "
32206|NCT03145480|"~     This research study studies the combination of ibrutinib and obinutuzumab with or without the~     standard chemotherapy regimen of CHOP to see how well these drugs work in treating patients~     with a diagnosis of Richter's Transformation or Richter's Syndrome. The Bruton's Tyrosine~     Kinase (BTK) inhibitor, ibrutinib, may stop growth of cancer cells by blocking the signal~     needed for cell growth. The monoclonal antibody obinutuzumab may block cancer growth by~     targeting cells present in Richter's Transformation. Giving ibrutinib with obinutuzumab may~     be a better treatment for patients with Richter's Transformation. Depending on fitness, the~     patients may receive ibrutinib and obinutuzumab in combination with a regimen known as CHOP~     (C= cyclophosphamide, H= hydroxydaunorubicin (also called doxorubicin), O= oncovin (also~     called vincristine, and P= prednisolone or prednisone (corticosteroids).~   "
32207|NCT03145467|"~     Migraine is a chronic and sometimes progressive disorder, characterized by headache,~     recurrent episodes, and other associated symptoms. Migraine is the most common cause of~     headache among patients who applied to emergency services.~      The purpose of the investigators is to compare the efficacy of oral paracetamol and~     zolmitriptan in the treatment of acute migraine headache in an emergency department.~   "
32208|NCT03145454|"~     Pain is a major problem in the care of children in pediatric emergencies. Indeed, its relief~     rests on the oral communication of the young patient, who does not always able to it~     (difficult to verbalize, fear of the hospital, problem mental development ...). There is no~     way in which pain can be apprehended objectively, immediately and effectively. To advance our~     knowledge of this problem, several approaches have been studied as from functional magnetic~     resonance imaging (fMRI), electroencephalography (EEG), or from autonomic parameters.~     However, all these approaches have their limitations: although fMRI presents interesting~     performances, it allows only a retrospective analysis, and cannot adapt to the clinical~     context of the young patient for example. EEG-based approaches and autonomic parameters show~     interesting results but suffer from perfectible sensitivity to muscle activation for EEG~     whereas the vegetative parameters to stress. In this context, our working hypothesis~     considers that the search for markers of painful perception must be based on a~     neurophysiological approach, based on the combined analysis of the EEG and autonomic~     responses in real time. The aim of this work is to study (1) the cortical (EEG) and autonomic~     (cardiovascular, skin, pupillary) responses induced by sutures in children who can~     communicate their pain according to whether they cause pain or not.~   "
32209|NCT03145441|"~     There are several factors initiating cytokine storm and systemic inflammatory response~     syndrome (SIRS) during cardiac transplantation. This may lead to serious perioperative~     complications: respiratory insufficiency, circulatory collapse, acute renal and liver~     failure, multi-organ dysfunction etc.~      On the other hand the high level of cytokines may play an important role in the development~     of graft rejection which is still a relevant problem in this patient group.~      There are some new data showing that the use of extracorporeal cytokine adsorber during long~     cardiopulmonary bypass time (>120min) may be beneficial to prevent SIRS with decreasing the~     level of cytokines in patients undergoing elective cardiac surgery. However there is lack of~     data and studies regarding the effect of extracorporeal cytokine adsorption during cardiac~     transplantation.~      The aim of the study is to investigate the effect of extracorporeal cytokine adsorber built~     in the cardiopulmonary bypass circle during heart transplantation. The hypothesis is that~     removing cytokines during transplantation in this patient group prevents the development of~     extreme systemic inflammatory response syndrome, early rejection and decreases the incidence~     of severe perioperative complications.~   "
32210|NCT03145428|"~     The measurement of monocyte volume width distribution (MDW) is intended for use with adult~     patients presenting to the emergency department (ED), where a CBC with Differential has been~     ordered, as an aid in the early detection of patients with or developing sepsis. The study~     will establish the clinical performance of MDW for detection of sepsis in the ED.~   "
32211|NCT03145415|"~     The purpose of this randomized blinded prospective study is to compare the analgesic efficacy~     and duration of a Pudendal Nerve Block (PNB) to a Caudal Block (CB) for pediatric patients,~     ages 6 months to 2 years, undergoing hypospadias repair.~   "
32212|NCT03145402|"~     This is a prospective, randomised double blind, controlled, parallel-group phase I and II~     study. Its aim is to assess that a single intracoronary infusion of autologous bone~     marrow-mononuclear cells is safe and effective in hear failure patients with reduced left~     ventricular ejection fraction(<=30%) when compared to a control group of patients undergoing~     best medical care.~   "
32213|NCT03145389|"~     Continuous thoracic epidural analgesia plays a very vital role in patients undergoing~     exploratory laparotomy. It not only supports a stable perioperative hemodynamics but also~     helps in early return of bowel activity.~   "
32255|NCT03144843|"~     This multicenter, randomized, double-blind study will evaluate the efficacy and safety of~     apatinib combined with paclitaxol versus placebo combined with paclitaxol in advanced gastric~     cancer or gastroesophageal junction carcinoma patients with peritoneal metastasis.~      Patients will be randomized to one treatment arm: Arm A: apatinib 500mg qd, Paclitaxol~     80mg/m2, d1, d8, d15,every 4 weeks ; Arm B: placebo 500mg qd, Paclitaxol 80mg/m2, d1, d8,~     d15,every 4 weeks ; Tumor assessment will be done every 8 weeks according to RECIST 1.1. The~     primary endpoint is progression free survival (PFS).~   "
32214|NCT03145376|"~     Since October of 2014, the Policlinico Umberto I Hospital has an Heart Team, a group of~     selected specialists with the task of assessing and identifying eligible patients for~     valvular aortic transcatheter implantation (TAVI) or a placement of a MitraClip .~      The specialists taking part to Heart Team are: a cardiologist, a heart surgeon, a vascular~     surgeon, an anesthesiologist and a geriatrician.~      The Geriatrician is called to make a careful multidimensional assessment of the elderly~     patients who have been suggested for the interventions mentioned above. His role is to assess~     the degree of co-morbidity and polypathology, autonomy in the common activities of daily~     living, nutritional status, cognitive status and quality of life. Following this evaluation,~     together with the other components of Heart Team, it is expressed a collective judgment on~     the patient's eligibility to these interventions. So, the aim of the present study is to~     identify changes in the degree of cognitive decline, of autonomy in carrying out activities~     of daily living, quality of life, nutritional status, pre- and postoperatively (6 months~     after the procedure) polypathology degree in elderly patients to be undergone or undergoing~     TAVI or positioning MitraClip because suffering from aortic valvular stenosis or severe~     mitral insufficiency. The patients undergo to a battery of tests, to a 5 minutes~     electrocardiographic record to evaluate the Heart Rate Variability (HRV) and to a complete~     echocardiographic evaluation.~   "
32215|NCT03145363|"~     The goal of this research project is to conduct a pilot RCT of Text4Strength, an interactive~     automated text messaging extension of Sources of Strength (SoS), a universal school-based~     suicide prevention program that prepares diverse 'key opinion leaders' to conduct public~     health messaging and activities with peers to increase school-wide positive coping norms,~     communication with trusted adults, and seeking help for suicidal peers (Wyman et al., 2010).~     The investigators previously developed and field tested Text4Strength messages (RSRB#00047481~     and 53924 closed) to demonstrate feasibility, safety, student engagement, and~     student-perceived relevance for a universal texting extension. The investigators will now~     conduct a pilot randomized controlled trial in one large school in Western New York that has~     implemented Sources of Strength for the past two years. The school will continue with Sources~     of Strength in the 2016-17 school, and add this school-wide texting component as part of this~     research study. Consistent with Leon's guidelines on pilot studies, the primary focus will be~     to identify areas of promise, success in reaching proximate targets, and the need for~     additional modifications (Leon, Davis, & Kraemer, 2011). Findings from this study will inform~     further refinement of the text messaging program and provide preliminary data for a larger~     efficacy trial.~   "
32216|NCT03145350|"~     Non-alcoholic fatty liver disease (NAFLD) is the most prevalent liver disease in the world.~     It is currently unclear why fat starts to accumulate in the liver, although both the amount~     and type of food consumed have been implicated. The majority of studies that have~     investigated the effects of dietary fat or sugar on liver fat have fed volunteers excess~     calories, which are known to increase liver fat. The effect of specific dietary components,~     when consumed as part of a diet not containing excess calories, on liver fat accumulation~     remains unclear.~   "
32217|NCT03145337|"~     Evaluation and comparison of clinical and aesthetic outcomes associated with the use of two~     allograft dermal matrices (ADMs) currently in use for tissue assisted immediate~     post-mastectomy breast reconstruction.~   "
32218|NCT03145324|"~     To collect the immunisation history of participants enrolled in a previous vaccine study (REC~     09/H0604/107) in order to assess the influence of genetic variation on the level of immunity~     to routine immunisations.~   "
32219|NCT03145311|"~     This study aims to evaluate the efficacy of rTMS on DITS. Twenty patients with DITS were~     recruited from the outpatient clinic of Aswan University Hospital. The patients were~     classified into two equal groups, 1st group received real high frequency rTMS at 100% RMT and~     the 2nd group received sham stimulation with the same pulse delivery but with the coil placed~     perpendicular to the scalp. For each patient 10 sessions were administered once per day for 5~     consecutive days each week for two weeks. All patients were assessed before rTMS and~     immediately after the end of the 10 sessions. This study is double blinded (the doctor and~     the patients). Assessment with AIMS scale and different parameters of cortical excitability~     were performed before and after the end of sessions treatment.~   "
32220|NCT03145298|"~     Pulmonary Arterial Hypertension or PAH is a progressive condition for which there is no cure.~     Even with substantial pharmacologic advances in the modern treatment era, survival still~     remains unacceptably poor, as reported in large PAH registries. Preclinical studies suggest~     that the administration of allogeneic CDCs have the potential to reduce adverse arteriolar~     remodeling in PAH which was the basis for the approved investigational new drug (IND). The~     use of CDCs as an adjunctive therapy in patients comprising 4 sub-groups of patients with PAH~     in which inflammation and immune dysfunction are key pathophysiologic drivers of PAH.~   "
32221|NCT03145285|"~     Adrenocortical Carcinoma (ACC) is an extremely rare disease. Approximately 50% of ACC in~     adults are functioning leading to hormonal and metabolic syndromes. Cortisol hypersecretion~     (Cushing's syndrome) is the most common endocrine derangement at presentation. Moreover,~     hypercortisolism is one of the factors that negatively influence the outcome of patients with~     metastatic ACC.~      Abiraterone acetate (AA) is a prodrug of abiraterone, an irreversible inhibitor of 17α~     hydroxylase/C17, 20-lyase (cytochrome P450c17 [CYP17]).The inhibition of CYP17A1 blocks~     androgen and cortisol synthesis. AA has a pharmacodynamic potential to reduce cortisol excess~     and it has never been tested before in Cushing's syndrome.~      Thus, we decided to evaluate the activity of Abiraterone Acetate in the management of~     Cushing's syndrome in patients with adrenocortical carcinoma. The study is a phase II,~     non-randomized, open-label study with two different experimental sub-cohorts:~      Cohort 1: Patients locally advanced/metastatic ACC patients with uncontrolled Cushing's~     syndrome despite Mitotane +/- chemotherapy will be treated with single agent AA. In this~     cohort, Mitotane and chemotherapy will be interrupted and AA will be continued till~     progression and/or as long as the Cushing's syndrome is adequately controlled (ie until~     progression of Cushing's syndrome).~      Cohort 2: Mitotane-naïve patients with newly diagnosis of ACC associated with Cushing's~     syndrome not amenable to surgical resection with radical intent will be treated with single~     agent AA for 4 weeks followed by AA + Mitotane +/- first-line chemotherapy. In this cohort,~     AA in association with Mitotane will be administered for 3 months. If the primary endpoint is~     obtained before 1 month (i.e. 2 or 3 weeks from Abiraterone start), then Mitotane +/-~     chemotherapy can be started upon the clinician's decision.~   "
32256|NCT03144830|"~     This study will examine the safety and feasibility of using an exoskeleton in subjects who~     are less than 6 months post spinal cord injury (SCI).~   "
32257|NCT03144817|"~     This is a pilot randomized clinical trial in which patients treated with 3X per weekly~     conventional hemodialysis will be treated to a dialysate sodium 135 mEq/L vs. 138 mEq/L and~     followed for safety and tolerability, effects on BP and volume.~   "
32222|NCT03145272|"~     This study is designed as an experimental trial which collect prospective data at Mahidol~     university. It aims to characterize the responses of Thai pediatric population,age 1 - 6~     years, to oxycodone oral syrup and its metabolites (oxymorphone, noroxymorphone and~     noroxycodone) with specific respect to the pharmacogenomics (How drug affects patients).~      A total of 20 generally healthy, opioid-naive children, aged 1-6 years, scheduled as~     in-patient surgery for non-emergency surgery, non-gastrointestinal tract surgery are~     involved.~      The patients are divide into 2 groups (1) 10 patients in 12 months - 1.9 years, and (2) 10~     patients in the 2 - 5.9 years age group.~      Every patient will receive inhalational or intravenous induction of anesthesia as decided by~     the anesthesia team on the day of surgery, as is routine clinical care. An intravenous~     cannula (IV) will be inserted in every patient as part of their routine clinical care. No~     additional intravenous line will be required for this study.~      As part of the study protocol, a blood sample (5 mL) will be taken from the IV and sent for~     genetic analysis. (However, in order to limit the amount of blood drawn from small babies, 3~     ml will be drawn, not 5 ml, if the patient is less than 6 months or less than 10kg.) The~     genetic testing is specifically to analyze the following genotypes only: CYP2D6 and CYP3A4,~     which represent the differences in cytochrome P450 metabolism of oxycodone.~      An orogastric tube will be placed in the stomach under anesthesia as is part of standard~     routine clinical care to remove gastric contents. The same orogastric tube will be used for~     intragastric liquid oxycodone administration in a dose of 0.1 mg/kg before the surgical~     incision. This weight-adjusted dose of 0.1 mg/kg is administered as per standard clinical~     dosing guidelines. 10 blood samples (51mL/sample) will be taken from the IV and sent for~     drug-level analysis. A total of 11 blood samples will be drawn for the study. The first~     sample will be sent for genetic testing. The other 10 samples will be drawn at the following~     time points: 30 minutes, 1, 1.5, 2, 3, 4, 5, and 6 hours post-dose in every patient and the~     other 2 samples anytime between 6 and 24 hours post-dose .~      Oxycodone, oxymorphone, noroxymorphone and noroxycodone levels, at 10 time points, will be~     used to determine the individual responses to oxycodone. CYP2D6 genotype will be determined~     to identify the ultra-rapid metabolizers.~   "
32223|NCT03145259|"~     The study will utilize already FDA-approved marketed diclofenac products in healthy adults to~     generate data for establishing rate of drug delivery comparisons between diclofenac epolamine~     patches and diclofenac sodium solution in healthy adults and to determine skin~     concentrations.~   "
32224|NCT03145246|"~     Many years ago, periodontal regenerative treatment has been done in Periodontics and Oral~     Medicine Clinic, Faculty of Dentistry, Mahidol University, Bangkok, Thailand. However, there~     is still lacking of study about long-term result of periodontal regenerative treatment of~     intrabony defects.~   "
32225|NCT03145233|"~     This pilot randomised controlled trial will directly compare the effect of isometric exercise~     to isotonic exercise over a period of 12 weeks for participants with a clinical diagnosis of~     Greater Trochanteric Pain Syndrome (GTPS).~   "
32226|NCT03145220|"~     EA-230 is a newly developed synthetic compound with anti-inflammatory properties, it is a~     linear tetrapeptide derived from the human chorionic gonadotropin hormone (hCG). Recently,~     its immunomodulatory effects in humans were confirmed in a phase I trial and an optimal dose~     was established. To establish this anti-inflammatory effect in a selected patient population~     and assess clinical outcome, a combined phase IIa/IIb trial will be conducted with patients~     undergoing cardiac surgery.~   "
32227|NCT03145207|"~     This is a bioequivalence study to compare lidocaine release between a brand name and generic~     skin patches in healthy adults.~   "
32228|NCT03145194|"~     This is a single-centred, double blind randomized controlled trial comparing ticagrelor with~     placebo in clopidogrel and aspirin loaded patients.~   "
32229|NCT03145181|"~     The purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule~     assessed to be safe for JNJ-64007957 and to characterize the safety and tolerability of~     JNJ-64007957 at the RP2Ds.~   "
32230|NCT03145168|"~     Study Design:~        -  A randomized controlled study.~        -  The study will be conducted on patients admitted to Department of Hepatology from April~          2017 to October 2017 at ILBS, New Delhi~        -  Study group will comprise of patients critically ill cirrhotics with septic shock~      All included patients would be randomised to low target MAP group (60-65mm Hg) or high target~     group (80-85 mm of Hg). Patients older than 18 years of age will be enrolled if they have~     septic shock that is refractory to fluid resuscitation and if they required vasopressors~     (norepinephrine or epinephrine or terlipressin) at a minimum infusion rate of 0.1 μg per~     kilogram per minute. Standard criteria will be considered to define refractoriness to fluids.~     The target MAP would be maintained for a max. of 5 days or until recovery or shock and or~     AKI. In the high-target group, a reduction in vasopressor doses to maintain a mean arterial~     pressure of 65 to 70 mm Hg will be done in case of any of the prespecified serious adverse~     events that could potentially be related to an increased rate of vasopressor infusion~     occurred. These events could be: clinically relevant bleeding (i.e., transfusion requirements~     of at least 2 units of packed red cells), myocardial infarction (defined as typical~     electrocardiographic changes, with a concomitant increase in troponin, and segmental~     echocardiographic hypokinesia or akinesia, with the infarction confirmed, when possible, by~     means of coronary angiography), major ventricular arrhythmia, poorly tolerated~     supraventricular arrhythmia, mesenteric ischemia, and distal-limb ischemia.~      • Septic shock would be defined as clinical construct of sepsis with persisting hypotension~     requiring vasopressors to maintain MAP>=65 mm of Hg and having a serum lactate >2 mmol/L~     despite adequate volume resuscitation~   "
32231|NCT03145155|"~     The objectives of this cluster randomized control trial are to examine the effect of combined~     intervention of the utilization of continuum of care (CoC) card and health education on the~     completion of CoC services among mothers and to examine the effect of health education on~     NCDs and nutrition on mothers' knowledge on NCDs and nutrition in Myanmar. Pregnant women~     between 12-20 weeks of pregnancy will be recruited and assigned into intervention arm (n=600)~     and control arm (n=600). The intervention package will comprise of two components, (1)~     utilization of CoC card and (2) health education on CoC in maternal, newborn and child health~     (MNCH), NCD and nutrition. The CoC card will include CoC services from first antenatal~     care(ANC) to last postnatal care(PNC) including four ANC, skilled birth attendance (SBA) and~     four PNC and essential services. Pregnant women will get stickers if they receive above~     services. Health education will be given three times during pregnancy and one time during~     postpartum period. Health education will include importance of continuous uptake of MNCH~     services, NCDs and nutrition. The outcomes are proportion of completion of CoC services and~     knowledge on NCDs and nutrition.~   "
32258|NCT03144804|"~     This research study is studying a drug as a possible treatment for p53 mutant metastatic~     colorectal cancer.~      The drug involved in this study is:~      -Lamivudine~   "
32259|NCT03144791|"~     Light influences on human movement, autonomic nervous system, and emotion. It is inconclusive~     whether illuminance (Ev) and colour temperature (Tc) is appropriate to human movement,~     autonomic nervous systme, and emotion. Effect of Ev and Tc on responses of movement,~     autonomic nervous system, and emotion in human is investigated.~   "
32232|NCT03145142|"~     Early hemodynamic effects (within 3 hours of life) of Delayed Cord Clamping compared to~     Umbilical Cord Milking are still unknown. Four sites experienced in the use of NIRS and who~     have appropriate data collection equipment in the delivery room (Alberta, Ulm, Cork and San~     Diego) will obtain and report the physiological changes with UCM and DCC from birth until 24~     hours of life. This data will yield the largest available sample of continuously recorded~     heart rate, cerebral tissue oxygenation, peripheral oxygen saturation, airway pressure, and~     administered FiO2 to delineate the short term responses to two methods of placental~     transfusion. In our initial trial we demonstrated increased blood pressure from 3-15 HOL with~     UCM compared to DCC in premature newborns <32 weeks, but did not show any differences in~     cerebral oxygenation.~   "
32233|NCT03145129|"~     Some people with Primary Open-angle Glaucoma (POAG) also suffer from Obstructive Sleep Apnoea~     (OSA), a common sleep disorder which is known to affect heart and blood vessels, and may~     contribute to glaucoma progression. Obstructive Sleep Apnoea is treated with Continuous~     Positive Airway Pressure (CPAP); however using this type of breathing support may raise~     intraocular pressure (IOP). The evidence for this is limited and the potential mechanisms~     involved are poorly understood.~      In this study we will determine whether CPAP applied at night changes IOP and ocular~     perfusion pressure (OPP). We will also assess its possible impact on ocular microvasculature.~     Two groups of patients will be included: those with POAG and OSA, and those with OSA without~     glaucoma. They will attend for two overnight assessments: the first before starting CPAP and~     the second 4-6 weeks into the treatment. Repeated measurements of IOP at night will be~     performed and participants will continue self-measuring IOP at home in the day. An Ocular~     Coherence Tomography Angiography (OCT Angiography) of the optic disc and the surrounding~     retina will be performed at baseline and after a few weeks of CPAP treatment.~   "
32234|NCT03145116|"~     Clinical safety and efficacy of CT ASPHINA 509 IOLs after implantation~   "
32235|NCT03145103|"~     Clinical safety and efficacy of CT ASPHINA 409 IOLs after implantation~   "
32236|NCT03145090|"~     Study the potential interest of bone scintigraphy for patients undergoing unicompartmental~     knee arthroplasty~   "
32237|NCT03145077|"~     The goal of this research study is to learn if performing MRIs after radiation treatment for~     head and neck cancer can predict osteoradionecrosis (a change in non-cancerous tissue).~      This is an investigational study. MRIs are performed using FDA-approved and commercially~     available methods. It is considered investigational to use MRIs to study the effects of~     radiation treatment on normal tissue.~      Up to 1400 participants will be enrolled in this study. All will take part at MD Anderson.~   "
32238|NCT03145064|"~     Screening (up to 28 days); daily treatment until disease progression, unacceptable toxicity~     or death, withdrawal of consent, lost to follow-up, or study termination from sponsor;~     treatment (up to 2 years), safety follow up (28 days); survival follow-up until data cutoff~     for final analysis.~   "
32239|NCT03145051|"~     Prospective, randomized, cross-over, multicenter, trial comparing the efficacy and~     tolerability of nasal irrigation with Respimer® mineral salts solution versus saline solution~     both administered with Respimer® Netiflow® medical device among patients aged ≥ 11 years and~     older with cystic fibrosis and suffering from chronic rhinosinusitis.~   "
32240|NCT03145038|"~     Vericiguat is intended to be used for the treatment of cardiovascular diseases, especially~     heart failure. Heart failure also occurs in children. Therefore, a study testing vericiguat~     in the treatment of heart failure in paediatric patients is planned under the paediatric~     investigational plan (PIP). In order to administer vericiguat to children, a vericiguat~     paediatric formulation is needed. This paediatric formulation is characterized in this study~     prior to its use in paediatric patients.~   "
32241|NCT03145025|"~     An Observational Change-From-Baseline Evaluation of Corneal Endothelial Cell Density in Eyes~     Treated with a Fluocinolone Acetonide Intravitreal Implant~   "
32242|NCT03145012|"~     The immune response against tumors can be highly effective in preventing tumor development,~     growth and metastasis under certain circumstances. However, tumor associated immune~     suppression can profoundly limit the impact of natural tumor immunity and also reduce the~     effectiveness of tumor immunotherapy strategies.~      A major component of tumor associated immune suppression is mediated by myeloid cells,~     especially the monocytic subset of myeloid derived suppressor cells (MDSC). In recent studies~     that were conducted through a CCSRI Innovation grant, the investigators discovered that oral~     treatment of mice with the commonly used histamine receptor 2 (H2) antagonists ranitidine or~     famotidine inhibits both primary breast tumor development and metastasis, in three distinct~     mouse tumor models and reduces the numbers of monocytic MDSC. These findings have enormous~     potential to aid in effective cancer immunotherapy and may have immediate implications for~     cancer patients.~      The objective of this investigation is to determine whether treatment with the H2 receptor~     antagonist ranitidine alters immune suppression, through modulation of immune cell~     populations.~      The investigators will examine peripheral blood monocyte, neutrophil and NK cell numbers,~     subsets and activation status from healthy volunteers treated for 6 weeks with daily oral~     ranitidine.~      Ranitidine is widely available and used over the counter in Canada. These drugs are widely~     recognized as safe, well tolerated and have very few side effects. It has been suggested that~     among the general population, over 10% of those over the age of 65 take such medications on a~     regular basis for relief against gastrointestinal discomfort. The outcome of pre-clinical~     studies in mice warrant further investigation into transferability to humans.~      If the outcome of the current proposal proves to be viable, then these drugs could provide a~     safe method to reduce tumor associated immunosuppression with broad implications, both for~     current cancer patients and for those at high risk of developing cancer. Further to this, the~     outcome of our proposal may provide a new strategy for improving the effectiveness of T-cell~     mediated immunotherapy.~   "
32260|NCT03144778|"~     The goal of this clinical research study is to learn if giving durvalumab alone or in~     combination with tremelimumab to patients with oropharynx carcinoma before standard-of-care~     surgery can help to control the disease.~      The safety of these drugs will also be studied.~      This is an investigational study. Durvalumab and tremelimumab are not FDA approved or~     commercially available for treatment of head and neck cancer. Their use in this study is~     investigational. The study doctor can explain how the study drugs are designed to work.~      Up to 28 participants will take part in this study. All will be enrolled at MD Anderson.~   "
32353|NCT03143569|"~     This study evaluates two different methods for monitoring a patient's anti-clotting [heparin]~     therapy after they receive a heart pump implant [left ventricular assist device -LVAD]. One~     method tests for how long it takes the patient's blood to clot and uses that to determine if~     they are on the right dose of heparin. The other method uses a more direct measure of how~     much heparin is in the blood. The hypothesis is that the method that more directly measures~     how much heparin is in the patient's blood will provide better medical results for the~     patient's care after they have the heart pump implant. To that end, the investigators are~     conducting this feasibility trial to establish the logistics associated with the~     implementation of these heparin monitoring approaches.~   "
32243|NCT03144999|"~     Age related macular degeneration (AMD) is the leading cause of vision loss in individuals~     over age 60. AMD is classified as wet and dry. Wet AMD constitutes 10 to 15% of all cases of~     AMD and occurs when an abnormal blood vessel grows in or under the retina leading to central~     vision loss. Wet AMD is successfully treated with injections in the eye on a monthly basis~     that stop the blood vessel from growing and leaking. The most common form of AMD is the dry~     variant or dry AMD that affects 85 to 90% of all patients with AMD. In dry AMD, there is loss~     of retinal pigment, formation of deposits called drusen, and loss of the vessels in a layer~     of the retina called the choriocapillaris. In the most severe forms of dry AMD there is loss~     of retinal tissue called geographic atrophy. Over time retinal tissue degenerates in the area~     responsible for central vision leading to vision loss leading to legal blindness. Currently~     no treatment for dry AMD exists so that there is a significant unmet need in patients with~     this ocular disease.~      Recently, evidence has implicated an overactive inflammatory cascade called the complement~     system as playing a pivotal role in the development of dry AMD. The complement cascade~     consists of 3 arms that converge to form a pore-like complex on the surface of cells called~     the membrane attack complex (MAC). Accumulation of MAC on cell surfaces leads to cell damage~     and death causing the clinical findings seen in AMD. Normal cells within the human body~     produce a protein on their cell surfaces called CD59 that blocks the MAC from forming. In~     AMD, the complement cascade is upregulated and leads to more MAC formation than the body can~     protect itself against leading to cell destruction.~      AAVCAGsCD59, an ocular gene therapy product that is injected in to the eye in the physician's~     office, causes normal retinal cells to increase the expression of a soluble form of CD59~     (sCD59). This soluble recombinant version of the naturally occurring CD59 is designed and~     intended to protect retinal cells that are responsible for central vision by inhibiting the~     formation of the membrane attack complex (MAC), the terminal step of complement-mediated cell~     lysis. In gene therapy the cells of the retina are potentially permanently altered to make~     sCD59 for the life of the patient. With gene therapy only one injection is needed for the~     drug to be effective for the patient's entire life. This study will evaluate the safety after~     a single injection of AAVCAGsCD59 administered in an office setting for patients whose~     enrolled eye has advanced dry AMD with geographic atrophy. The initial study is 26 weeks~     followed by an additional 18-month safety evaluation.~   "
32244|NCT03144986|"~     OBJECTIVE: Anorexia Nervosa (AN) is a complex disorder of unknown etiology that is~     characterized by disordered eating behaviors and specific psychopathology. In the course of~     anorexia around 50% will recover in the first 10 years, 25% will continue to experience~     symptoms but will be able to function, and 25% will go to develop chronic course, and by~     definition become severe treatment resistant(Tr). There is little if anything to offer to~     this population where the range of treatment options is limited to weight restoration~     interventions. Transcranial magnetic stimulation (rTMS) is a non-invasive intervention, which~     presents a particular interest in people with severe TrAN, specifically because of its~     ability to target deeper areas of the brain, such as insula, which has been argued to be a~     possible trait marker for AN. METHODS: This pilot study will test the efficacy and safety of~     deep-rTMS delivered with the H-coil in subjects with long standing treatment resistant severe~     anorexia nervosa (TrAN).~   "
32245|NCT03144973|"~     Periodontitis is a infection of mouth gingival mucosa and connecting tissue. It has been~     shown in previous studies to have a effect on the risk of heart diseases getting worse and~     elevate risk in heart surgery. The investigators are studying periodontitis and how it~     affects upper gastrointestinal tract patients complication rates and the quality of~     complications.~   "
32246|NCT03144960|"~     Assessment of Therapeutic benefits and hazards of Mechanical Thrombectomy in Ischemic stroke~     patients with proximal occlusion within 4.5 hours from stroke onset.~   "
32247|NCT03144947|"~     Phase II, Open Label, Randomized, Biomarker Study of Immune-mediated Mechanism of Action of~     Neoadjuvant Subcutaneous (SC) Trastuzumab in Patients with Operable or Locally Advanced~     /Inflammatory HER2-positive Breast Cancer (ImmunHER)~   "
32248|NCT03144934|"~     This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose~     study to evaluate the safety and tolerability of GX-I7 in HPV-infected female volunteers~   "
32249|NCT03144921|"~     EPIC II (Early-Stage Partners in Care) is a research project designed to assist people with~     early-stage memory loss and their care partners by providing early-stage related education~     and skill-training sessions designed to reduce stress, enhance well-being, manage challenges,~     and plan for the future. Researchers will gather feedback from individuals about their~     experience to continue to improve programs for early-stage memory loss.~   "
32250|NCT03144908|"~     Design of this study is to collect data and review Principal Investigators standard operating~     procedures on allergy testing and changes made to their specific SOP.~   "
32251|NCT03144895|"~     Monitoring of invasive blood pressure and / or cardiac output of resuscitation patients is~     required and recommended. The installation of an arterial catheter in intensive care is very~     frequent and subject to many complications. These complications are now well recognized in~     the literature, they are mainly vascular, infectious and thrombotic. They are directly~     influenced by the number of attempts to puncture and the time taken to perform the gesture.~     Many measures are taken to reduce the impact such as the choice of the site of installation,~     the strict aseptic techniques during the installation and the type of catheter used. However,~     despite these measures, it appears that the incidence of these complications remains high.~     Compared to anatomical marking, only the technique of laying the ultrasound-guided catheter~     has shown its effectiveness in reducing these complications. The management in intensive care~     of increasingly complicated, severe, elderly patients with significant comorbidities~     increases from year to year. To the knowledge of the investigator, there is no study on the~     impact of ultrasound arterial catheterization in patients in resuscitation.~   "
32252|NCT03144882|"~     Programmed ingestion of turmeric has no adverse effects and reduces plasma level of hs-CRP,~     IL-6 and TNF-α accompanying with increases albumin levels in hemodialysis patients. Turmeric~     can be considered as an effective anti-inflammatory supplement in hemodialysis patients.~   "
32253|NCT03144869|"~     Physical activity (PA) can have positive health outcomes for children with type 1 diabetes~     (T1DM), yet being physically active can have unwanted side effects due to fluctuations in~     blood glucose (BG) level. Children and parents need support to help understand the~     relationship between PA and BG level, and how to use PA as a vehicle to better manage the~     condition. Using PA monitoring could help HCPs raise awareness about PA, discuss PA and~     facilitate diabetes management. This research will explore the feasibility and acceptability~     of PA monitoring as a clinical tool to help the management of paediatric T1DM.~   "
32254|NCT03144856|"~     This study is designed to see whether Apatinib is effective in treating patients with~     advanced refractory biliary tract cancers.~   "
32354|NCT03143556|"~     This is a pilot, single-centre, feasibility study to assess the feasibility issues and~     collect preliminary clinical data for the design of future randomized controlled trial to~     evaluate the feasibility and patient comfort of magnetic retrieval device removal of ureteral~     stent in transplant patients.~   "
32261|NCT03144765|"~     Radical rectal cancer resection, namely total mesorectal excision (TME), is the cornerstone~     of the treatment of resectable rectal cancer. In combination with chemotherapy and radiation~     treatment (CRT), complete TME with negative resection margins is associated with sustained~     local and systemic control even in locally advanced disease. Over the last 2 decades,~     laparoscopic and robotic techniques have been increasingly adopted due to reduced surgical~     trauma and faster patient recovery. Yet, both approaches are associated with equivalent~     postoperative morbidity and disturbances in sexual, urinary and defecatory function relative~     to open TME. Furthermore, laparoscopic and robotic TME remain associated with substantial~     conversion rates and variable rates of TME completeness as a result of the procedural~     difficulties reaching the low rectum from the abdominal approach. Transanal TME (taTME) with~     laparoscopic assistance was developed to facilitate completion of TME using a primary~     transanal endoscopic approach. Transanal TME uses a bottom-up approach to overcome the~     technical difficulties of low pelvic dissection using an abdominal approach. Published~     results from single-center taTME series and an international registry suggest the short-term~     procedural and oncologic safety of this approach in resectable rectal cancer. No multicenter~     phase II study has yet been conducted to validate the procedural safety, functional outcomes~     or long-term oncologic outcomes of this approach.~      Study Design: This is a 5-year phase II multicenter single-arm study to evaluate the safety~     and efficacy of low anterior resection (LAR) with taTME using laparoscopic or robotic~     assistance in 100 eligible subjects with resectable rectal cancer.~      Hypothesis: taTME is non-inferior to standard LAR with respect to the quality of the TME~     achieved.~   "
32262|NCT03144752|"~     The purpose of this study is to determine if medical, biological, psychological, and social~     risk factors can be used to develop algorithms that will predict perinatal depression (PND).~     Data capture will include baseline participant medical, psychological and family history,~     blood biomarkers, and psychosocial assessments.~   "
32263|NCT03144739|"~     Background: Mental health problems cause a disproportionate burden of disability among~     children and youth compared to adults. Primary care plays an important role in efforts to~     prevent and intervene early in the course of child and adolescent mental health problems.~     While research with adults has shown the feasibility of integrating mental health care into~     primary care settings, there have been few studies among children and youth. Evidence remains~     lacking that integration is feasible in diverse settings, that it improves outcomes, and that~     methods can be developed to address the mixed symptoms of emerging child/youth problems and~     their overlap with developmental and parental disorders.~      Goals: The purpose of this project is to test the effectiveness of adding a child/youth~     mental health component into an existing collaborative care program for adult mental health~     problems. The work will refine a framework for efficient cultural adaption and tailoring of~     an existing child/youth primary care mental health intervention and then test whether the~     tailored intervention results in improved child and parent outcomes. The work will also~     provide evidence about the mechanisms by which those outcomes are achieved and what factors~     influence uptake of the child/youth component by general practitioners (GPs). These results~     should be generalizable to low and middle income countries and to underserved areas of the US~     where there are minimal child mental health resources and family physicians provide the bulk~     of medical care for children and youth.~      Methods: The planned work involves the adaptation/tailoring process followed by a trial with~     45 GPs already engaged in collaborative care for adults; the trial will study adding~     collaborative care for children ages 5-15. GPs will be randomly assigned in groups to begin~     6-month control periods involving child mental health screening and referral. They will then~     receive child/youth training and begin second 6-month periods of screening plus ongoing~     coaching and booster sessions and collaborative management. Primary outcomes will be measured~     by recruiting and following for 6 months two cohorts of children/youth and their parents (one~     control, one collaborative care). Data collected from GPs, parents, youth, and the~     collaborative care data system will allow measurement of key factors that determine the~     program's success in helping children and families.~   "
32264|NCT03144726|"~     Surgical site infections following lower extremity amputations have been reported in up to~     40% of patients. Surgical site infections have significant morbidity and even mortality in~     terms of emergency room visits, length of hospital stay, reamputation rates and death. Since~     its introduction, negative pressure wound therapy has been demonstrated to promote wound~     healing and possibly decreasing the need for future amputations. The aim of the study is to~     provide level I evidence for the use of negative pressure wound therapy devices in patients~     undergoing lower extremity amputation.~   "
32265|NCT03144713|"~     -  Study Population: Patients admitted or seen in Out Patient Department, Department of~          Hepatology, Institute of Liver and Biliary Sciences.~        -  Study Design: Prospective Open Labeled Randomized Controlled Trial.~        -  Study Period: January 2017 to December 2017~        -  Intervention- Subjects will be randomized to 3 groups~        -  All patients will receive Standard medical therapy - Albumin-8g/L of tap- one half of~          dose at beginning of tap and rest half after 6 hours of tapping.~      Group A - Subjects will receive Terlipressin 1mg intravenous bolus at the onset of~     paracentesis and the remaining as 1 mg doses intravenous at 8 and 16 h after the first dose.~     ( total -3mg) Group B - Midodrine 7.5 mg TDS x 3 days Group C - Standard medical therapy only~        -  Monitoring and Assessment: Clinical evaluation will be done at regular intervals.~        -  Adverse Effects: Rise in blood pressure, arrthymias, hyponatremia and rarely~          cardiovascular side effects have been noted.~        -  Stopping Rule: Development of PICD, hypertension ( BP>160/90mmhg-JNC class II)~   "
32266|NCT03144700|"~     Study Design and Methodology~        -  Study Population:Compensated Cirrhosis~        -  Study Design: An Ambi Prospective Cohort study~        -  Study Period: 2 Years~        -  Sample size: Retrospective- All patients from Jan 2010 to Mar 2017 Prospective- Assuming~          the incidence of clinical decompensation is 5%/year.With alpha of 5%, power 80% we need~          to enroll 138 cases. Further assuming 20% drop out 166 cases will be enrolled.~        -  Intervention: This is an observational study. No intervention will be given.~      Monitoring and assessment: All the routine investigation and clinical information will be~     collected at 6, 12,18 and 24 months.~   "
32267|NCT03144687|"~     The purpose of this study is to evaluate the efficacy and safety of itacitinib combined with~     low-dose ruxolitinib or itacitinib alone in subjects with myelofibrosis.~   "
32268|NCT03144674|"~     The purpose of this study is to evaluate the safety and efficacy of two INCB050465 treatment~     regimens in participants diagnosed with relapsed or refractory marginal zone lymphoma (MZL)~     who are naive to or were previously treated with a Bruton's tyrosine kinase (BTK) inhibitor.~   "
32269|NCT03144661|"~     The purpose of this study is to evaluate the safety and tolerability, and determine the~     maximum tolerated dose of INCB062079 in subjects with advanced hepatocellular carcinoma and~     other malignancies.~   "
32355|NCT03143543|"~     The purpose of Project 2 is to execute phase I functional magnetic resonance imaging (fMRI)~     studies to assess the effects of lorcaserin on brain target engagement (measured by fMRI~     brain activation and neural connectivity) in cocaine use disorder (CocUD) subjects and/or~     opioid use disorder.~   "
32270|NCT03144648|"~     Breast cancer has become a major public health problem in Latin America, as it is the most~     common form of cancer among women. Women are more likely to develop breast cancer at younger~     age, and to be diagnosed at an advanced stage compared to western women. Over the past twenty~     years, the mortality from breast cancer in Latin America has also been increasing very~     rapidly, and is currently the leading cause of cancer mortality. Little is known on specific~     risk factors for premenopausal breast cancer in general, and in Latin America in particular.~     There is a lack of specific knowledge on tumor molecular and pathological characteristics of~     breast cancer in Latin America premenopausal women, and this has major consequences on cancer~     treatment and survival.~      To improve our understanding on determinants of breast cancer incidence and mortality in~     young Latin America women and support preventive actions, we implemented an international,~     population-based multi-center study in Latin America: the PRECAMA study (Molecular Subtypes~     of Premenopausal Breast Cancer in Latin American Women (PRECAMA): a multicenter~     population-based case-control study).~      PRECAMA is coordinated by the International Agency for Research on Cancer (IARC), and is~     conducted within 4 Latin American countries: Mexico, Costa Rica, Colombia and Chile. Major~     aims of the project are the following:~        1. To develop a multi-centric population-based case-control study on breast cancer in~          premenopausal women in several countries in Latin America with structured collection of~          individual, clinical, pathological information and biological specimens, according to~          strictly controlled protocols~        2. To characterize, in these populations, the subtypes of premenopausal breast cancer on~          the basis of their molecular and pathological phenotypes~        3. To improve the identification of specific endogenous/exogenous factors, and disentangle~          the interplay of these different factors with regard to breast tumor subtypes.~        4. Provide advanced training, induce a structuring effect on the breast cancer research~          community in Latin America and influence the public health agenda regarding the~          management of breast cancer.~      The results of our study will be of utmost importance to understand the etiology of breast~     cancer in Latin America countries, and would provide important information on the role of~     modifiable exposures for breast cancer prevention.~   "
32271|NCT03144635|"~     The regimen using grazoprevir plus elbasvir treatment is promising in Japan, because it may~     safely be used for the elderly patients with renal dysfunction. Grazoprevir and elbasvir are~     metabolized in the liver and do not require dose-adjustment for patients with renal~     dysfunction. However, no data related to efficacy and safety of the grazoprevir plus elbasvir~     treatment for Japanese elderly patients with renal dysfunction (eGFR<60 mL/min/1.73m2) have~     been reported. Therefore, physicians are at a loss whether or not to treat the patients with~     renal dysfunction due to no evidence.~      The aim of this study is to investigate the improvement of serum endostatin level of Japanese~     patients with CKD stage 3 after grazoprevir (NS3/4A protease inhibitor) plus elbasvir (NS5A~     replication complex inhibitor) treatment by a prospective, multicenter cohort study.~   "
32272|NCT03144622|"~     This study aims to compare the diagnostic performance of 18F-FDG and 18F-FSPG PET/CT in lung,~     breast, and abdominal cancers before undergoing therapy. In addition, the role of 18F-FSPG~     PET/CT in evaluating therapy response and prognosis will also be evaluated.~   "
32273|NCT03144609|"~     The prevalence of obese patients in a great number of patients scheduled for elective surgery~     under general anesthesia has been on the increase. Recent studies suggest an intraoperative~     protective mechanical ventilation for the obese. Surgical procedures in the oral cavity~     increase the risk of perioperative complications of obese patients. By making this randomized~     clinical study, investigators want to determine whether the protective intraoperative~     ventilation with the use of higher positive end-expiratory pressure and recruitment maneuvers~     compared to ventilation with low positive end-expiratory pressure and without recruitments~     cause better postoperative respiratory function parameters of obese patients during oral~     surgical procedures. Investigators also aim to establish the fact which value of a positive~     end-expiratory pressure has a favorable impact on the respiratory function without negative~     hemodynamic effect.~   "
32274|NCT03144596|"~     It was aimed to evaluate and investigate the effects of tamsulosin hydrochloride, has~     preferential selectivity for the α1A receptor in the prostat versus the α1B receptor in the~     blood vessels, and alfuzosin hydrochloride on choroidal thickness (CT), pupil diameter sizes~     evaluated by using enhanced depth imaging spectral-domain optical coherence tomography~     (EDI-OCT) and scheimpflug/placido photography-based topoghraphy system in this study.~      63 men patients with newly diagnosis of benign prostatic hyperplasia were randomly assigned~     to either alfuzosin hydrochloride or to tamsulosin hydrochloride groups in this prospective,~     randomized, parallel-group clinical trial. Enhanced depth imaging spectral-domain optical~     coherence tomography, pupillography were obtained at baseline, 1st and 3rd month, and~     choroidal thicknesses and pupil diameter sizes were compared between the 2 groups.~   "
32275|NCT03144583|"~     To assess the infusion of ARI-0001 cells (Adult differentiated autologous T-cells from~     peripheral blood, expanded and transduced with a lentivirus to express a chimeric antigen~     receptor with anti-CD19 specificity [A3B1] conjugated with the co-stimulatory regions 4-1BB~     and CD3z ) safety on patients with leukemia or lymphoma CD19+ resistant or refractory to~     treatment and with a prognosis of less than 2 years.~   "
32276|NCT03144570|"~     Prospective observational multicenter study in European ICUs. All patients admitted to the~     ICU for probable or confirmed Acute encephalitis (2013 IDSA - Infectious Disease Society of~     America criteria) will be included. Factors associated with a poor prognosis will be~     identified by multivariate analysis using a logistic regression.~   "
32277|NCT03144557|"~     This study evaluates the implementation of an education protocol and its impact on the~     correct inhalation technique in COPD patients presenting errors or mistakes. There will be 4~     sessions, in each one the inhalation technique will be evaluated using a checklist of steps.~     Whenever errors are found, the correct use of each device will be educated through verbal~     explanation and written material will be delivered.~   "
32278|NCT03144544|"~     When considered from a provincial perspective, quantification of surgical procedures~     undertaken by different hospitals and healthcare networks is necessary for informing resource~     allocation and modelling of healthcare services. The investigators hypothesized that i)~     non-physiologically complex surgical procedures would account for most (>1/2) of pediatric~     surgical procedures performed at both pediatric specialist hospitals and the other hospitals~     performing pediatric surgery, ii) surgical discharges for non-physiologically complex~     surgical procedures would account for most (>1/2) in-hospital bed nights among pediatric~     surgical admissions at both pediatric specialist hospitals and the other hospitals performing~     pediatric surgery, and iii) the relative distributions of non-physiologically complex~     surgical procedures, but not physiologically complex procedures, would be at least moderately~     similar between pediatric specialist hospitals and the other hospitals performing pediatric~     surgery. To test these 3 hypotheses, the specific objectives of this study were to estimate~     i) the proportion (primary outcome) of non-physiologically complex pediatric surgical~     procedures, and ii) the similarity and diversity (secondary outcomes) of non-physiologically~     and physiologically complex surgical procedures between the pediatric specialist hospitals~     and the other hospitals performing pediatric surgery in Ontario, Canada.~   "
32279|NCT03144531|"~     Behavioral intervention for 6-11 year children with persistent asthma and sleep disturbance~     and a parent with sleep disturbance.~   "
32280|NCT03144518|"~     This study is a 2-arm, parallel, randomised controlled feasibility trial of a brief video~     intervention designed to induce positive affect (mood) in older adults in primary care~     settings prior to the receipt of influenza vaccination. Participants will be randomised into~     two conditions: experimental and active control. In the experimental condition, participants~     will view the approximately 15 minute long intervention video immediately prior to~     vaccination. In the active control condition, participants will view a matched video that is~     designed to be mood neutral. Pre-and-post positive affect levels will be assessed by~     self-report questionnaires. Immune response to the intervention and vaccination responses~     will be assessed in saliva and serum samples respectively.~      The objectives of the study are to assess the impact of the intervention on mood, immune~     function, and antibody response to influenza vaccination in older adults. This feasibility~     trial will also allow data collection on exploring recruitment, attrition, intervention~     engagement, and practicality of collecting clinical data available through electronic records~     to inform the design of a future definitive trial.~   "
32281|NCT03144505|"~     To overcome the lack of knowledge regarding the relative role of different intensities of~     aerobic training in adults with type 2 (T2D) diabetes, a 12 month randomized controlled trial~     will be performed to assess and compare the impact of two exercise groups: 1- high intensity~     interval training (HIIT) with resistance training; 2- moderate continuous training (MCT) with~     resistance training; and 3- a standard counseling home based control group; on hemoglobin A1c~     (HbA1c) as the main outcome, and other selected cardiometabolic, body composition and quality~     of life markers, as secondary outcomes. This investigation aims to increase the current~     knowledge on HIIT and the related benefits on diabetes control and treatment in a time saving~     and physiological efficient framework, which will improve the general health and well-being~     of the diabetes population. A total of 105 participants with T2D will be recruited from the~     Lisbon area (35 control, 35 HIIT, and 35 MCT). The investigators hypothesize that~     high-intensity interval training, compared to moderate continuous training, will optimize the~     physiological adaptations and quality of life in people with type 2 diabetes.~   "
32282|NCT03144492|"~     The goal of this study is to assess the affect of ground based microgravity on co-cultured~     vascular cell types. Our goal is to better understand the cross-talk between vascular cell~     types grown under conditions such as microgravity as is seen in space. In this pilot study,~     the investigator proposes to assess changes in cell phenotype and function in microgravity as~     compared to normal gravity.~   "
32283|NCT03144479|"~     A technique not yet described in the literature and allowing anesthesiologists who do not~     regularly practice fibroscopy or who do not routinely have this type of apparatus for their~     procedures, to install straight double-lumen tubes without compromising the ventilation of~     the patient. The aim is to introduce a central venous catheter wire guide into the bronchial~     arm of the right double-lumen tube and insert it into the right upper lobe bronchus orifice~     under fluoroscopic control. Then, to validate the new technique, we will carry out a~     fibroscopic control.~   "
32284|NCT03144466|"~     Locally advanced cervix cancers (stage 1B-IV) are usually treated with radiotherapy,~     concomitant cisplatin chemotherapy and brachytherapy. Failure to achieve locoregional control~     (LRC) remains a problem, especially in the setting of stage III/IV disease. More importantly,~     however, the dominant unresolved problem remains the occurrence of distant metastatic~     relapse. With the knowledge that 99% of all cervix cancer is associated with human~     papillomavirus (HPV) infection, there is a strong rationale to consider immunomodulatory~     strategies in the radical management of this disease. Therefore, in this research protocol~     the investigator will treat patients with stage 1B-IVA carcinoma of the cervix planned to~     receive radical radiotherapy with concomitant cisplatin and brachytherapy. The research~     involves adding a new therapy in the form of an antiPD1 monoclonal antibody (pembrolizumab)~     to the standard treatment of radiotherapy combined with cisplatin chemotherapy and~     brachytherapy. This treatment seeks to activate the patient's own immune system to attack the~     cancer cells - and the investigator believes that adding this treatment during standard~     treatment may be particularly effective. Patients will receive an initial dose of~     pembrolizumab 2 weeks before starting a course of chemoradiotherapy and brachytherapy. In the~     first instance, patients will receive 100 mg of pembrolizumab and, if this is safe and~     tolerable in the first 3 patients, the dose will be increased to 200 mg for all other~     patients. Radiation will be delivered on 28 occasions with chemotherapy given intravenously~     in weeks 0, 1, 2 and 3. Brachytherapy will be given on 3 occasions after completion of the~     radiation. Additional doses of pembrolizumab will be given every 3 weeks for a further 7~     doses. The investigator will assess the feasibility and safety of the combination of~     pembrolizumab with radiotherapy and cisplatin.~   "
32285|NCT03144453|"~     Robot-assisted radical cystectomy (RARC) requires specific surgical conditions: steep~     Trendelenburg position, prolonged pneumoperitoneum, effective neuromuscular block until the~     final stages of surgery. The aim of this study was to evaluate the quality of awakening in~     two groups of patients undergoing different combinations of curarization/reversal.~   "
32286|NCT03144440|"~     Primary objective:~      1. To estimate the effectiveness of treatment with FDC of Zepatier with or without ribavirin~     in Israeli patients with CHC and advanced fibrosis in real life setting.~      Secondary objective:~      1. To estimate the safety and tolerability of treatment with FDC of Zepatier with or without~     ribavirin in real life setting in Israeli patients with CHC and advanced disease.~      Hypotheses:~      Effectiveness and tolerability of treatment with FDC of Zepatier with or without ribavirin in~     Israeli patients with CHC and advanced fibrosis will be similar to that demonstrated in phase~     3 clinical trials.~   "
32287|NCT03144427|"~     This is a prospective, non-interventional, observational study of consecutive burn patients~     admitted to 20 selected burn centers in North America. Primarily, data collection will be~     continuous real-time documentation of fluid infusion rates, vital signs and laboratory~     values of patients receiving fluid resuscitation during the first 48 hours following burn~     injury. All aspects of the resuscitation and all investigations performed will be according~     to the participating center's regular protocol, as this is purely an observational and~     non-interventional study. Further data collection on outcomes (organ function, ventilation~     duration, length of stay, and survival) will be collected at 72h, 96 h, and at hospital~     discharge.~   "
32288|NCT03144414|"~     This prospective randomized clinical trial will be conducted in Ain Shams University~     Maternity Hospital during the period from May 2017 to December 2017. Group Ι: 30 patients~     will undergo conventional laparoscopic assisted vaginal hysterectomy (LAVH). Group ΙΙ: 30~     patients will undergo laparoscopic assisted Doderlein vaginal hysterectomy (LADH)~   "
32289|NCT03144401|"~     This prospective double-blind placebo-controlled randomized clinical trial will be conducted~     at Ain-Shams University Maternity Hospital from April 2017 till October 2017. 120 women~     candidate foe elective cesarean section will receive preoperative sublingual 400 microgram of~     misoprostol, and another 120 women will receive postoperative sublingual 400 microgram of~     misoprostol.~   "
32290|NCT03144388|"~     The primary goal of the proposed study is to identify the contributions of the amount of~     task-specific practice on locomotor (i.e., walking) recovery in patients with chronic (> 1~     yr) motor incomplete spinal cord injury (iSCI). Consistent with principles of motor learning~     and exercise physiology, the investigators contend that certain training (i.e., dosage)~     parameters of physical rehabilitation are critical to mobility outcomes following~     neurological injury. Specifically, the specificity, amount and intensity of physical~     interventions (i.e., practice) may influence specific outcomes in the patient population~     treated. In ambulatory patients with iSCI, there are very few studies that have controlled~     for or targeted these training variables or their influence on locomotor recovery. Previous~     work suggests these training parameters may influence locomotor recovery in patients with~     other neurological disorders (i.e., stroke), although few studies have attempted to delineate~     similar contributions of in iSCI. Indeed, no studies have carefully controlled the amount of~     task-specific practice during physical rehabilitation of patients with iSCI, and such~     interventions are rarely utilized in the clinical setting. The goal of the present study is~     to delineate the relative contributions of amount of task-specific training on locomotor~     outcomes in individuals with iSCI. Using a cross-over, randomized clinical trial design, the~     investigators anticipated non-specific (i.e., non-stepping) training activities would result~     in smaller improvements as compared to task-specific (stepping) training. The investigators~     will investigate the effects of such training on walking performance and kinematics, as well~     as the impairments thought to contribute to walking performance. Successful completion of~     this project could have an immediate impact on rehabilitation research and treatment of~     people following iSCI, and may be utilized to treat more subacute patients with iSCI or other~     acute-onset neurological disorders.~   "
32291|NCT03144375|"~     Chronic rhinosinusits (CRS) is common disease with reports of prevalence ranging from 4-16%~     in the western population. The main outcome measure for chronic disease treatment, such as~     CRS, is quality of life. Several large multi-institutional studies have shown that~     improvement in disease specific Quality of life was greater in patients who had surgery for~     their CRS with polyps. The timing of surgery in these patients has not been well studied but~     it is generally agreed upon that surgical candidates much had failed medical management. The~     definition of medical management varies greatly but usually includes some form of nasal or~     oral steroids and a prolonged ( >10 days) course of antibiotics.~      Another known way to improve QOL is through education and individualized optimization. This~     has been utilized successfully in other fields with good success and improved QOL. Similar~     studies looking at combining non-surgical optimization and education have not been performed~     in CRS. This study aims to address this potential area for improvement in patient quality of~     life outcomes. Investigators plan to assess the potential role for pre-operative non-surgical~     medical and educational optimization in CRS standard of care treatment.~   "
32292|NCT03144362|"~     Sciatica is a debilitating and costly condition. Prognostically, patients presenting with leg~     pain often have a poor recovery and some go onto have spinal surgery. However, in the absence~     of nerve root compression on MRI, no surgical option is viable and patients are often~     discharged and encouraged to self manage. Neurodynamics offers a means to treat patients with~     non-compressive leg pain. To date, there is no research exploring which form of neurodynamic~     sliding technique offers the greatest therapeutic benefit in patients presenting with~     sciatica. The aim of this pilot study is to calculate how many patients would be needed to~     run a full scale trial evaluating therapeutic efficacy. Moreover, the pilot will assess the~     overall workability of the study and the feasibility of patient recruitment.~   "
32293|NCT03144349|"~     The aim of the study is to analyze if blood protein concentration variation during continuous~     renal replacement therapy (CRRT) with fluid removal can predict a decrease of 15 % of cardiac~     index in intensive care unit (ICU) patients. Blood protein concentration, clinical data~     describing hemodynamic status (providing data from Pulsion medical system PiCCO2 ®~     monitoring), including preload dependency evaluation with passive leg raising, are collected~     at different times: before initiation of fluid removal, and after the first episode of~     hypotension or one hour after initiation of fluid removal.~   "
32294|NCT03144336|"~     This project called Mobile Technology and Incentives (MOTIVES) aims to increase engagement~     with HIV prevention information and improve testing frequency among Latino/a men who have sex~     with men (MSM) and transgender women (TGW). Its primary goal is to develop and test the~     feasibility and acceptability of an HIV prevention intervention that uses text messages in~     combination with prizes to improve HIV prevention information retention and HIV testing~     frequency. The project will be conducted in collaboration with Bienestar Human Services, Inc.~     (Bienestar) in Los Angeles County. Phase 1 consists of formative research (focus groups n=9)~     with MSM (n=52) and TGW (n=39) to complement the previously collected pilot data (2014-2015)~     to finalize the planned intervention. In Phase 2, the intervention will be piloted among 5~     individuals, implemented, and tested in a small, randomized controlled trial (RCT) among 200~     Latino MSM and TGW from Bienestar's HIV testing sites. Interested individuals will be~     screened for eligibility upon testing HIV-negative (those testing positive will be linked to~     HIV services as required by Bienestar's standard of care). Eligible participants will be~     randomized into either the intervention or control group that will both receive study~     information weekly and will be invited to get tested for HIV every three months. Participants~     in the intervention group will be able to accumulate rewards points for correctly answering~     weekly quizzes regarding the HIV prevention information; these reward incentives aim to~     encourage retention in the study and improve HIV prevention knowledge engagement and~     recollection. Every three months those in the intervention group can win a prize based on~     testing HIV-negative at least once during that time period. The chance of winning will~     increase based on the number of reward points a participant accumulates by correctly~     answering questions on the weekly quizzes. The primary outcome measures will include~     HIV-preventive knowledge and frequency of HIV testing (at least once every 3 months). In~     Phase 3 of the study, the investigators will conduct 6 focus groups with approximately 5-8~     participants each among MSM (n=3) and TGW (n=1) study participants, testing site staff (n=1),~     and administrative staff (n=1) to identify implementation challenges and areas for~     improvement; and estimate mission-critical design parameters with point and confidence~     interval estimates to inform a subsequent, fully-powered R01 application.~   "
32295|NCT03144323|"~     Fixed orthodontic appliances in combination with intraoral elastics are a common and~     effective method use in the orthodontic correction of malocclusions. However, their success~     is largely dependent on the patient's compliance. Failure to wear the elastics as instructed~     will reduce efficacy of treatment, ultimately increasing treatment time and potentially~     producing imperfect alignment of teeth.~      The hypothesis tested is that daily electronic reminders via a mobile application can~     significantly increase patient compliance, thus effectively improving treatment outcomes.~   "
32296|NCT03144310|"~     Pre op ultrasound with chest auscultation and arterial blood gas, after extubation ultrasound~     with chest auscultation and blood gas, 12hrs chest auscultation with ultasaound, 24 hrs chest~     auscultation and ultrasound to see atelectasis~   "
32307|NCT03144167|"~     No predictive factors are known for the response to the bevacizumab anti-angiogenic molecule~     (Avastin) given in the event of relapse of glioblastoma (GBM) following radiochemotherapy.~     Classical MRI with gadolinium injection and perfusion is not sufficient to predict survival~     and response or duration. We propose to evaluate the prognostic interest for 6-month survival~     of spectroscopic biomarkers of proliferation, glial reaction, infiltration and glutaminergic~     metabolism or glycolytic metabolism recorded at 7 and 28 days of application of the~     treatment.~      These biomarkers are based on the increase of an index combining choline / Creatine (Cho /~     Cr), Glx / Cr (Glutamine and glutamate / Creatine), NAA / Cr (N acetyl aspartate / Creatine)~     and lactate / Cr ratios. The long-term objective is to predict the survival of these relapsed~     GBM patients at an early stage and to identify responder patients who would benefit from this~     expensive molecule and avoid using it in non-responding patients~   "
32297|NCT03144297|"~     Background: It has already been established that there is a weak positive relationship~     between increased intracranial pressure (ICP), as measured by lumbar puncture manometry, and~     increased Body Mass Index (BMI). This is also observed clinically in some patients with~     idiopathic intracranial hypertension, who typically have raised BMI. The relationship between~     BMI and percentage body fat is non-linear, especially at BMI > 40. The Bod Pod device enables~     non-invasive body composition profiling, including accurate calculation of percentage body~     fat, without the use of radiation.~      Aim: To examine the relationship between intracranial pressure as measured by lumbar puncture~     manometry and percentage body fat as measured by air-displacement plethysmography (Bod Pod)~      Methods: 100 patients undergoing routine diagnostic and therapeutic lumbar punctures for a~     variety of non-emergency neurological conditions will be recruited. Cerebrospinal fluid~     opening pressure will be measured using standard manometry techniques. Blood pressure,~     height, weight, collar size, waist size and hip size will be measured. Body composition~     profiling will be carried out using the Bod Pod.~   "
32298|NCT03144284|"~     Minimal intervention dentistry (MID) is a modern medical approach that aims to maximize~     preservation of healthy dental tissues. When operative intervention is required it is as~     minimally invasive as possible. This study will assess the knowledge of a group of dental~     interns regarding minimal intervention dentistry in Egypt and whether this knowledge is~     translated into positive attitude and practice among them.~   "
32299|NCT03144271|"~     This trial is conducted in Europe. The aim of this trial is to assess the safety and~     tolerability of ascending single s.c. doses of NNC 0113-0217 in healthy male subjects, aiming~     at establishing the Maximum Tolerated Dose (MTD)~   "
32300|NCT03144258|"~     General objective of the research project: To evaluate the alterations of systemic~     microvascular reactivity during cardiopulmonary bypass (CPB), in children submitted to~     cardiac surgery for repair of congenital heart defects.~   "
32301|NCT03144245|"~     This is a first in human, non randomized, open-label, dose escalation study to investigate~     the safety, tolerability and preliminary efficacy of AMV564.~   "
32302|NCT03144232|"~     This investigation will preliminarily determine if a course of high frequency rTMS applied to~     the left dorsolateral prefrontal cortex, will reduce cue elicited craving, and cue reactivity~     in treatment seeking cannabis use disordered participants.~   "
32303|NCT03144219|"~     Introduction: Intracranial pressure (ICP) monitoring is essential in several neurological~     situations, however, this is an invasive technique, costly and could be contraindicated or~     unavailable. Transcranial Doppler (TCD) pulsatility index (PI) measure can provide indirect~     information on the cerebrovascular resistance (CVR) augmentation, which is present~     concomitantly with intracranial hypertension (ICH). The hypothesis that PI measure accurately~     indicates cerebral compliance impairment (CCI) has been not assessed by large studies~     currently, and would be of value as a non invasive technique to denote earlier installing of~     therapeutics to prevent the effects of ICH.~      Objective: The present study aims to assess PI accuracy indicating CCI, and dynamic cerebral~     auto regulation (dCAR) during internal jugular veins (IJVs) compression.~      Methods: A prospective, observational controlled study, including critical neurological~     patients with ICP monitoring in normal range (under 20 mmHg). Initially, dCAR is monitored,~     then, the IJVs are compressed for 60 seconds with ultrasound guidance. We evaluate optic~     nerve sheath prior to intervention, and dCAR, ICP values, ICP waveforms and PI variation at~     different times, correlating results.~   "
32304|NCT03144206|"~     A prospective, randomized investigation with appropriate power would determine whether or not~     postoperative hyperbaric oxygen therapy improves wound healing in patients with soft tissue~     sarcoma undergoing surgical resection with neo-adjuvant radiation therapy.~   "
32305|NCT03144193|"~     Photoaged or chronically sun-exposed skin is characterised by a number of clinical features~     including fine and coarse wrinkles. The pathogenesis of wrinkle formation has yet to be~     determined fully but recent work suggests that ultraviolet radiation-induced reduction in~     dermal fibrillin (in the form of fibrillin-rich microfibrils) is important. Using an extended~     in vivo patch test assay, it has been identified that skin care products - currently marketed~     by CG Skin Ltd - increase the deposition of these microfibrils in photoaged dermis and hence~     have the potential to repair photoaged skin. The Investigators now propose to examine the~     efficacy of the product in randomized, placebo-controlled clinical trial.~   "
32306|NCT03144180|"~     Currently there is no standardized method of collecting and transferring umbilical cord blood~     to laboratory vacuum tubes. Current methods are messy and may require needles to draw the~     blood presenting risk of blood exposure and percutaneous injury to obstetrical personnel. A~     safer, more efficient method of collecting cord blood is needed. The investigators propose to~     use the Q-Cup technology for collecting cord blood. The Q-Cup device is a two-piece injection~     molded blood collection and transfer device that enables safe and easy collection of blood~     from the newborn's umbilical cord and readily transfers the blood into a laboratory vacuum~     tube. The device consists of a collection cup with a wide opening to easily collect blood~     from the umbilical cord and a guide tube with a recessed needle which is attached to the~     collection cup. The operator is enabled to fill the required vacuum containing tubes in a~     clean, quick, efficient and safe manner by simply inserting the vacuum tube into the guide~     tube of the Q-Cup. As a result, there is less risk of blood exposure and percutaneous injury~     and blood is collected more efficiently. This device allows the practitioner to collect and~     transfer umbilical cord blood: without the need for removing the stopper from the vacuum tube~     (reducing mess and contamination) and without the need for a syringe and exposed needle~     (reducing injury and infection).~   "
32351|NCT03143595|"~     Preexisting cognitive impairment, such as mild cognitive impairment, is common in many~     elderly patients who undergoing major surgeries. Accumulating evidence has demonstrated that~     preexisting cognitive impairment is associated with increased mortality, increased incidence~     of postoperative complications, decreased quality of life, and worse outcomes. However, few~     studies have evaluated the relationship between preexisting cognitive impairment and~     cognitive trajectories and clinical outcomes.~   "
32356|NCT03143530|"~     The pectoralis block, including pecs I and II block, is a novel technique first described in~     2011 as an alternative to paravertebral blockade for analgesia following breast surgery. The~     research goal is to determine the efficacy of the pectoralis block compared to placebo in~     improving quality of recovery following mastectomy.~   "
32308|NCT03144154|"~     Hypnosis-based interventions are starting to be tested in order to improve emotional distress~     and fatigue of cancer patients. However, most of these studies only include breast cancer~     patients and do no measure long-term effects of such interventions.~      Our randomized controlled trial aims to propose to 116 post-treatment cancer patients (all~     tumour localisations accepted) an 8-week groupal intervention combining hypnosis and~     self-care techniques.~      Primary outcomes (emotion regulation, emotional distress, fatigue) and secondary outcomes~     (sleep difficulties, fear of recurrence, attentional bias, conjugal communication) will be~     investigated at 3 measurement times: before the intervention (T1), 3 months later (T2 - right~     after the intervention of the experimental group, and right before the intervention of the~     control group) and again 3 months later (T3 - after the intervention of the control group).~     Some questionnaires, two relaxation tasks, an attentional task, an actigraph and a smartphone~     application will be used to collect data. The indirect impact of the intervention on~     participants' partners will also be measured by questionnaires (emotional distress, conjugal~     communication).~      Data collection has started on March 2017. Our results should bring new knowledge about the~     efficacy of an hypnosis-based intervention to improve fatigue and well-being in cancer~     patients, which are often under-diagnosed and under-treated, but also about the indirect~     efficacy to improve partners' well-being. Those results might contribute to spread this kind~     of inexpensive intervention in oncology settings.~   "
32309|NCT03144141|"~     Preterm delivery accounts for about 10% of deliveries in France. Prematurity is the leading~     cause of perinatal morbidity and mortality in economically developed countries. Despite the~     development of therapeutics and paraclinic examinations, this rate of preterm delivery~     remains stable or even increases. The use of medically assisted procreation techniques alone~     can not explain this rate.~      The analysis of the electrical activity of the uterus (electrohysterograms) is a promising~     technique for early diagnosis of the risk of premature delivery, allowing better management~     of the patients. This study is part of a European theme to study risk factors for the~     prevention of prematurity.~   "
32310|NCT03144128|"~     The proposed study is aimed at examining mitochondrial function as a potential target of~     action of vitamin D on muscle metabolism, size, and strength in preventing the progression of~     cachexia. This is the first clinical trial designed to understand the effects of vitamin D on~     muscle metabolic dynamics driving dysfunction in cachectic muscle. Our preliminary data~     suggest that vitamin D promotes lipid partitioning and muscle metabolic function, which the~     investigators hypothesize, will mitigate cachexia via improved muscle health and quality that~     translates into reduced fatigue, and improved patient resilience to multimodal cancer~     therapy.~   "
32311|NCT03144115|"~     The aim of the study is to explore how the rewarding effect of men's verbal compliment is~     modulated by oxytocin and gonadal hormone in a romantic context.~   "
32312|NCT03144102|"~     Stroke represents one of the main causes of adult disability and will be one of the main~     contributors to the burden of disease in 2030. However, our healthcare systems do not have~     enough resources to cover the current demand let alone its future increase. There is a need~     to deploy new approaches that advance the current rehabilitation methods and enhance their~     efficiency.~      One of the latest approaches used for the rehabilitation of a wide range of deficits of the~     nervous system is based on virtual reality (VR) applications, which combine training~     scenarios with dedicated interface devices. On the other hand, recent studies have shown the~     potential of transcranial direct current stimulation (tDCS) to restore motor function in~     hemiparetic stroke patients. It must be emphasized, however, that so far little work exists~     on the quantitative assessment of the clinical impact of VR based approaches in combination~     with tDCS protocols. We hypothesize that the combination of VR-based motor rehabilitation~     protocols with concurrent anodal tDCS can boost functional recovery, and may achieve superior~     effects when compared to 3 alternative treatments: 1) VR without tDCS, 2) occupational~     therapy with tDCS, and 3) occupational therapy without tDCS.~      The findings derived from this study will contribute to establish a novel and superior~     neurorehabilitation paradigm that can accelerates the recovery of hemiparetic stroke~     patients. Besides the clinical impact, such achievement could have relevant socioeconomic~     impact.~   "
32313|NCT03144089|"~     The Articulating Oral Airway (AOA) is a novel oral airway which actively displaces the~     tongue, allowing for a greater cross-sectional area for mask ventilation. The investigators~     hypothesize that, in patients with predictors for difficult mask ventilation, the AOA will be~     non-inferior to the Geudel oral airway in terms of expired tidal volumes.~   "
32314|NCT03144076|"~     In this study, the investigators use a randomized field experiment in Karnataka, India, to~     measure the effects of a free inpatient public health insurance plan, Rashtriya Swasthya Bima~     Yojana (RSBY), on health and poverty. RSBY is India's first large-scale national public~     health insurance program, and was adopted in 2008 to cover below poverty line (BPL)~     households. This study examines the impact of expanding RSBY to cover above poverty line~     (APL) households that are not covered by RSBY or other secondary hospital care insurance~     plans. The study will examine the impact of a public insurance program on a range of health~     and economic outcomes to capture the full range of benefits from insurance. The goal of the~     study is to quantify how the RSBY program benefits health and reduces poverty. Differences in~     the outcomes between the treatment and control groups over the duration of the project will~     measure the causal effect of health insurance on health and financial outcomes. The~     investigators believe this will serve as a platform for the future of development of RSBY,~     and provide further insight into the effectiveness of health insurance in low-income~     countries.~   "
32352|NCT03143582|"~     The investigators are interested in finding accessible interventions for youth and young~     adults that help promote long-term positive mental health functioning. They will be~     investigating the effects of Team Unbreakable, a 13-week, twice weekly running group, on~     mental health symptoms, memory, and attention. This intervention will hopefully improve~     mental health functioning in youth aged 17-25 that are at high risk of developing mental~     health disorders. Sessions will consist of 30 minutes of running under the supervision of~     group leaders and coaches. The group will steadily increase the distance and time spent~     running versus walking, with the goal of having everyone run a 5 km race together at the end~     of 13 weeks. Once a week, youth will be provided with education on a variety of topics~     related to health and running. Youth will complete measures before, during, and after the~     program to assess outcomes.~   "
32315|NCT03144063|"~     Physicians' assessment of disease activity in SLE is fundamental but challenging. The~     Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K) is one of the most commonly~     used disease activity indices. Clinical trials experience suggested that the disease activity~     instruments did not function well on their own, and composite measures were developed to~     address this issue. This approach has been adopted after learning from clinical trials that~     the absence of a robust sensitive index is a major flaw when designing a trial. Another issue~     with clinical trials is the confounding effect of corticosteroids, which to date have been~     the most effective treatment for the management of lupus. However, unregulated use of~     corticosteroids in drug trials decrease the investigator's ability to differentiate between~     the tested drugs and placebo as they appear to enhance response among the placebo arm and~     thus mask the effect of the tested drug.~      In this study, the aim is to develop and validate a new index, SLEDAI-2K Glucocorticosteroid~     Index (SLEDAI-2KG). It is very challenging to evaluate improvement in drug trials in the~     context of the standard of care treatment which includes corticosteroids. This novel index,~     SLEDAI-2KG, will help to overcome the confounding effect of corticosteroids and to allow for~     more accurate description of disease improvement and thus facilitate accurate investigations~     of new therapeutic agents.~   "
32316|NCT03144050|"~     This study is designed to evaluate the ability of Spatial Frequency Domain Imaging (SFDI) to~     measure perfusion in lower extremities and to understand how it might be used in a podiatry~     clinic.~   "
32317|NCT03144037|"~     This is an observational trial designed to assess prospectively the adherence rate to AIs~     among women with invasive breast cancer (stages I-III) currently receiving AI adjuvant~     therapy after standard local and systemic therapy. We will study adherence by administrating~     the 8-item Morisky Medication Adherence Scale (MMAS - 8).~   "
32318|NCT03144024|"~     randomized study which include comparison rigid ring and band devices in treatment tricuspid~     regurgitation.~   "
32319|NCT03144011|"~     Acute kidney injury (AKI) is a common complication in patients with congenital heart defects~     after cardiopulmonary bypass (DentC.L.,MaQ., 2007, PedersenK.R., HjortdalV.E., 2008,~     Zappitelli M., BernierP .L., 2009). The death rate from AKI in critically ill children~     remains high and reaches 60% (FlynnJ.T., 2002).~      The basic criteria for diagnosing and assessing the severity of kidney injury until recently~     were the level of serum creatinine and the amount of urine released~     (KDIGOclinicalpracticeguidelineforacutekidneyinjury, 2012).~      However, it should be noted that the level of serum creatinine, traditionally used to assess~     renal function, does not significantly increase until a decrease of more than 50% of the~     glomerular filtration rate, in addition, its level depends also on some extrarenal causes.~     Artificial blood circulation and hemodilution leads to the preservation of the level of~     creatinine at sufficiently low levels up to 1-3 days postoperative period (ParkM.,CocaS.G.,~     2010). The level of diuresis as well as the level of creatinine is a nonspecific criterion~     after cardiac surgery and depends on several factors.~      Currently, in the field of acute renal injury studies, progress has been made in the~     emergence of new biomarkers such as the tissue inhibitor metalloproteinase-2 (TIMP-2) and~     insulin-like growth factor binding globulin-7 (IGFBP7), which are early markers of acute~     renal damage in (Kashani K., Al-Khafaji A., 2013, Bihorac A., Chawla L. S., 2014. In a study~     in adult patients (MeerschM.,SchmidtC., 2014), it was shown that the levels of TIMP-2 and~     IGFBP7 increased In the first 24-48 before the diagnosis of IR-associated renal damage.~      Among pediatric patients with congenital heart defects, such studies are single and only~     present for the age group 3 and older (MeerschM., SchmidtC., 2014), which also demonstrated~     the high specificity and prognostic significance of these biomarkers in the early diagnosis~     of acute renal damage.~      It should also be noted that, in spite of the high specificity of the markers described, it~     is also necessary to note their considerable cost.~      Thus, taking into account the above, it is planned to compare and identify the relationship~     of these indicators with such parameter as the index of renal vascular resistance, the~     increase of which in the pre- and postoperative period may serve as a sign of the beginning~     acute renal injury.~   "
32320|NCT03143998|"~     This is a non-randomized, open-label study of a fixed dose combination (FDC) of elbasvir (50~     mg) and grazoprevir (100 mg) (EBR/GZR or MK-5172A) in participants with chronic hepatitis C~     virus (HCV) genotype 1 (GT1) infection with advanced fibrosis with and without human~     immunodeficiency virus (HIV) co-infection. All participants will be either HCV treatment~     naïve (TN) or treatment experienced (TE).~   "
32321|NCT03143985|"~     The purpose of this study is to see if the study drug, called TEW-7197, is safe and determine~     what the best dose is to treat future patients when given in combination with pomalidomide~     (POM). The study will also look to see if it has any effect on multiple myeloma, when given~     in combination with POM.~   "
32322|NCT03143972|"~     The objective is to map the pharmacokinetic / pharmacodynamic interaction between~     dexmedetomidine and remifentanil by observing changes in anesthetic depth. These changes will~     be related to drug concentrations using pharmacokinetic/pharmacodynamic (PKPD) modeling.~   "
32323|NCT03143959|"~     The study investigates the impact of abdominoplasty in the post partum population on the~     symptoms of back pain and urinary incontinence. Patients presenting for abdominoplasty fill~     out validated questionnaires for both back pain (Oswestry Disability Index) and urinary~     incontinence (ICIQ-UI short form). They complete the same questionnaires 6 weeks and 6 months~     post op. The prospectively gathered data gives an insight into the incidence of functional~     symptoms in this post partum group preop as well as the degree of improvement gained postop.~     This is a multicenter trial with 9 surgeons submitting patients to the study, which ran for~     19 months.~   "
32324|NCT03143946|"~     This study aims to investigate if the proportion of neuroendocrine tumor (NET) patients with~     normal vitamin values can be increased, with vitamin suppletion and a personalized diet,~     Effects of the intervention will be evaluated by quantitative analysis of blood and urine and~     questionnaires. The measurements, will be performed at baseline (t=0), after 4 weeks (t=4)~     and after 18 weeks at end of study (t=18). Furthermore at t=18 a semi-qualitative interview~     will be performed.~   "
32325|NCT03143933|"~     It is hypothesized that propofol, when used in general anesthesia (GA) influence patient's~     stress status and consequently affect stress response parameters. Hence, the objective of the~     presented research is to assess whether the propofol has anti-stress effect or not in~     patients undergoing surgeries that require GA and classified as The American Society of~     Anesthesiologists physical status 1 (ASA PS1)~   "
32326|NCT03143920|"~     Pilot study to determine feasibility for treating patients with two chronic inflammatory~     conditions of the urinary bladder: chronic interstitial cystitis and recurrent urinary tract~     infections using a standardized hyperbaric oxygen treatment plan. Presently there are no good~     treatments for these conditions and hyperbaric oxygen may be a safe and readily accessible~     therapy as it has proven successful an another type of chronic inflammatory condition of the~     urinary bladder known as radiation cystitis. The study will determine if patients will~     consider this an acceptable treatment for their conditions and that it is well tolerated.~   "
32327|NCT03143907|"~     Recent research has suggested that mindfulness-based interventions (MBI) for psychosis may be~     effective in reducing the negative symptoms of schizophrenia (e.g., social withdrawal, lack~     of motivation) and the distress associated with psychotic symptoms (e.g., hearing voices) and~     could lead to improvements in functioning and quality of life. MBI research to date has~     primarily focused on studies of patients with chronic psychotic illness, yet relatively~     little is known about the use of MBIs for youth recovering from their first episode of~     psychosis. Results from recently published pilot studies appear promising in terms of the~     feasibility, acceptability, and potential clinical utility (e.g., improved psychological~     symptoms) of MBIs for the early psychosis population (Ashcroft et al., 2012; van der Valk et~     al., 2013; Khoury et al., 2015). The current project team has completed a pilot study at the~     Prevention and Early Intervention Program for Psychoses (PEPP) at London Health Sciences~     Centre (LHSC), wherein the Mindfulness Ambassador Council (MAC), a 12-week facilitated~     group intervention promoting mindfulness skills and the development of emotional and social~     competencies, was shown to be an effective, feasible, and acceptable means of treating youth~     in the early stages of psychotic illnesses. In follow up to the initial pilot study, the~     purpose of this study is to perform a multi-site Randomized Control Trial to determine the~     effectiveness of the MAC group intervention on reducing psychotic disorder symptomatology for~     transitional aged youth experiencing early psychosis. The main hypothesis, based on previous~     findings on the use of MBIs in psychotic disorders, including results from our initial pilot~     study at PEPP, is that youth with early psychosis who participate in the MAC group~     intervention will experience a reduction in their negative and positive symptoms of psychosis~     and affective symptoms compared to those receiving treatment as usual (TAU). Furthermore, we~     expect that youth experiencing early psychosis who participate in MAC will have an~     improvement in their quality of life, measures of recovery (self-esteem, perceived recovery),~     perceived coping, assertiveness, mindfulness and cognitive skills, and a reduction in~     healthcare service utilization (e.g., emergency room visits, inpatient admissions/length of~     hospitalization).~   "
32328|NCT03143894|"~     This study will test the preliminary efficacy of transcranial direct current stimulation~     (tDCS) to improve fatigue and cognition in women with a history of breast cancer and~     persistent fatigue.~   "
32329|NCT03143881|"~     This study evaluates the impact of a new education-based intervention on outcomes in un- and~     under-insured Heart Failure (HF) patients presenting to the Emergency Department (ED) for~     care. Intervention patients will receive personalized education regarding their condition,~     pre- and post-testing of their HF knowledge base, and ED standard of care during the~     enrollment (index) visit. Patients will then be contacted via telephone 30 days post-index~     visit for re-testing and reinforcement of previously learned material. Patients in the~     control group will receive ED standard of care.~   "
32330|NCT03143868|"~     This study plans to learn more about how type of exercise influences measures of appetite~     regulation. In this study, investigators will be evaluating a resistance exercise session~     (using weight machines and free weights) and an aerobic exercise session (using a treadmill).~     Participants will also complete a sedentary control condition.~      A secondary purpose is to compare sex-based differences in appetite-indices in response to~     exercise. Therefore, the responses to aerobic and resistance exercise will also be compared~     between men and women.~   "
32331|NCT03143855|"~     The overall goal of this project is to develop initial human data on effects of novel~     compounds on safety (interactions with oxycodone) and efficacy (subjective response to~     oxycodone) in non-treatment seeking opioid use disorder subjects. The compound to be studied~     will be the 5-HT2CR agonist lorcaserin. There are no known or reported adverse interactions~     between lorcaserin and oxycodone or other opioids.~   "
32332|NCT03143842|"~     The purpose of this study is to investigate whether it is possible to accelerate learning and~     improve memory performance in VNS implanted tinnitus participants by pairing VNS with a~     verbal paired-associate learning task.~   "
32333|NCT03143829|"~     The purpose of the project is to estimate the effect size of a technology based intervention~     for older adults with cancer for nausea and vomiting. Participants will be randomized to~     either an intervention or a wait control group. Outcomes such as symptom severity, quality of~     life and resource use will be examined.~   "
32334|NCT03143816|"~     This is an investigator-initiated, prospective, randomized, multicenter, parallel,~     open-label, pilot clinical trial evaluating the efficacy of TI for PPBG, PPGE, and~     time-in-range on CGM download in patients with T1D. TI is an inhaled ultra-rapid-acting~     insulin, approved by the FDA for use in patients with diabetes. This is a pilot, real-life~     study where patients will continue their routine diabetes care and use post-meal correction~     dosages as deemed necessary for normalizing PPBG as per the protocol.~      This multi-center study will enroll 60 patients with T1D, A1c values between 6.5 to 10%. The~     patients will be randomized in 1:1 fashion to either TI or NL. Patients who are randomized~     into the NL arm will continue using their usual prandial insulin dose before meals. Patients~     who are randomized into the TI arm will be instructed to dose before the meals and take~     necessary corrections at 1- and 2-hours after meals to optimize PPBG (Table 1B). There will~     be a total of 7 study visits (screening visit, randomization visit, 2 clinic, and 3 phone~     visits). There will be a 4-week treatment comparison between TI and NL and 1-week of~     post-study follow up. (Phone visit; Figure-1). Standard lab tests (A1c, complete metabolic~     panel {CMP}, complete blood count {CBC}) will be performed at the screening visit.~      All patients will use real-time CGM (Dexcom G5®, San Diego, CA), which will be provided at~     the randomization visit for their day-to-day diabetes care. CGM data will be downloaded at~     every clinic visit on a secured computer. The data will be analyzed after the study for~     different primary and secondary end points. All patients will be allowed to keep the CGM~     after the study is over for their day-to-day diabetes care.~   "
32335|NCT03143803|"~     The aim of the study is to get insight into control of glycemic variability with Sugar~     Balance capsules which is the leaves of three herbs: ivy ground (Coccinia indica)-200mg,~     bougainvillia (Bougainvillea spectabilis)-30mg, Madagascar periwinkle (Catharanthus~     rosea)-20mg.~   "
32336|NCT03143790|"~     Extra Corporal Shock wave Therapy Has proven effective as treatment with mild to moderate~     erectile dysfunction in men with erectile dysfunction. Investigator will examine whether the~     treatment also applies to men with moderate to severe erectile dysfunction after nerve injury~     associated with prostatectomy.~   "
32337|NCT03143777|"~     This study investigates the impact of introducing an early mobilisation device called the~     Sara Combilizer on time taken to mobilise in critical care. The investigators will collect~     baseline data on time taken to mobilise for a period of 4 months, then following a training~     programme and introduction of the device for a further 4 months~   "
32338|NCT03143764|"~     This study aimed to examine cycling time and distance when inactive subjects were provided~     with electrically assisted bicycles, and secondly, to examine changes in cardiorespiratory~     fitness.~   "
32357|NCT03143517|"~     The primary objective is to obtain stool samples from subjects diagnosed with , and~     displaying signs and/or symptoms of IBD and/or IBS will be evaluated in this study. Eligible~     subjects require a diagnostic colonoscopy with possible biopsy and clinical evaluation.~   "
32339|NCT03143751|"~     Traumatic brain injury (TBI) is a major cause of death and severe prolonged disability.~     Intracranial hypertension (ICH) is a critical risk factor of bad outcomes after TBI.~     Continuous infusion of hyperosmolar therapy has been proposed for the prevention or the~     treatment of ICH. Whether an early administration of continuous hyperosmolar therapy improves~     long term outcomes is uncertain. The aim of the current study is to assess the efficiency and~     the safety of continuous hyperosmolar therapy in TBI patients.~      The COBI trial is the first randomized controlled trial powered to investigate whether~     continuous hyperosmolar therapy in TBI patients improve long term recovery.~      Hypothesis~      Patients treated with early continuous hyperosmolar therapy have reduced morbidity and~     mortality rates compared to those receiving standard care alone after traumatic brain injury.~      Research Questions~        1. Does early continuous hyperosmolar therapy reduce morbidity and mortality rates at 3 and~          6 months after TBI assessed by the GOSE questionnaire?~        2. Does early continuous hyperosmolar therapy prevent intracranial hypertension?~   "
32340|NCT03143738|"~     Comparison of continuous adductor canal block to continuous femoral nerve block in patients~     after total knee arthroplasty.~      All patients will be anesthetized with spinal anesthesia. Continuous infusion of ropivacaine~     with a catheter implemented to the adductor canal or next to the femoral nerve.~      The observed goals: pain intensity, the beginning and quality of rehabilitation.~   "
32341|NCT03143725|"~     This study is a Phase I, randomized, open-label, cross-over study with 4 single-dose~     treatments of GLPG1972 to compare the bioavailability of the oral wet granulation (WG) tablet~     relative to an oral solution and to the oral direct compression (DC) tablet after single dose~     intake in healthy male subjects and to evaluate the effect of food on the bioavailability of~     the WG oral tablet.~   "
32342|NCT03143712|"~     This study is a Phase I, randomized, open-label, cross-over study with three single-dose~     treatments to compare the bioavailability of an oral tablet relative to an oral capsule of~     GLPG1690 after single dose intake in healthy male subjects and to evaluate the effect of food~     on the bioavailability of the oral tablet.~   "
32343|NCT03143699|"~     The present study aims to investigate the effect of immediate feedback on long-term blood~     pressure measurement skills. This is a randomized controlled trial including first year~     students from a Brazilian medical school, which will be randomized in two groups: an~     intervention group (submitted to a training on blood pressure measurement skills and an~     immediate feedback) and a control group (submitted to a training on blood pressure~     measurement skills, but with no immediate feedback). Then, students will be assessed 3 months~     after the feedback in order to see whether there will be a difference between groups. Our~     hypothesis is that students submitted to immediate feedback would have better scores in the~     blood-pressure measurement skills after 3 months. A knowledge questionnaire as well as a~     standardized patient scenario will be used to assess students' knowledge and skills.~   "
32344|NCT03143686|"~     Post-market registry on ACURATE TA™ Transapical Aortic Bioprosthesis and ACURATE TA™ Delivery~     System implantation in patients presenting severe symptomatic aortic stenosis to provide~     safety surveillance of the device.~   "
32345|NCT03143673|"~     The purpose of this study is to evaluate safety of the study device and study device~     performance in patients presenting with severe aortic stenosis who are considered to be high~     risk for open surgical repair.~   "
32346|NCT03143660|"~     The goal of this study is to investigate whether eight weekly telephone coaching sessions or~     materials on lifestyle interventions can be beneficial for overweight and obese 8-12 year~     olds.~   "
32347|NCT03143647|"~     Magnesium has built up the reputation of a 'natural calcium antagonist'. However, the exact~     effect of magnesium on coagulation and more specifically on platelet function is still~     disputed. An important discrepancy between in vivo and in vitro studies exists. Magnesium has~     thus been reported to antagonize platelets in some studies, and to stimulate platelets in~     other studies. Current evidence seems to point in the direction of a general antagonization~     of aggregation and coagulation.~      Intravenous magnesium is often administered in pre-eclampsia as seizure prophylaxis.~     Therapeutic regimens usually consist of an intravenously administered loading dose (2-3~     grams) and a maintenance infusion, targeting a plasma level of 2-3 mmol/L. Therapeutic drug~     monitoring is needed, as magnesium toxicity is an important concern.~   "
32348|NCT03143634|"~     Currently, our best psychological treatments for anxiety and mood disorders only focus on~     individual diagnoses. So, there are separate treatments for Panic Disorder, or Depressive~     Disorder, or Social Anxiety, etc. These 'diagnosis-specific' treatments work well for people~     whose problems fit neatly into a single diagnosis. However, they work far less well for~     people with complex problems involving multiple diagnoses, and 50% of patients fail to~     respond well to these existing treatments.~      The purpose of this study is to test a new psychological treatment for anxiety and mood~     problems (the Modular Protocol for Mental Health [MPMH]). Instead of focusing on any single~     diagnosis, MPMH combines the best treatment techniques into 10 modules to target problems~     common across all of the different mood and anxiety diagnoses (e.g., intense emotions,~     negative thinking, upsetting memories, distressing habits). MPMH should therefore be a better~     treatment for the large numbers of individuals whose problems do not fit neatly into a single~     diagnosis and for whom any treatments targeting a single diagnosis would leave significant~     difficulties unaddressed.~   "
32349|NCT03143621|"~     Post-operative ileus (post-op ileus) is a condition which can occur after surgery. This~     means that the bowels stop working correctly and food and liquids will not pass through in~     the normal manner. Post-op ileus can be uncomfortable and require a longer hospital stay~     until the bowels begin to function correctly again. Currently there are no effective methods~     for preventing post-op ileus. Some studies suggest there is a benefit from drinking coffee~     following colon or gynecological cancer surgeries with very little risk. However, the effects~     of coffee following small bowel surgery have not been studied. This randomized, controlled~     trial will compare the outcomes of patients who receive coffee during their hospital stay~     after small bowel surgery to similar patients who receive warm water. About 60 patients will~     be in each group. The main outcomes are time until the nasogastric tube is removed and length~     of hospital stay.~   "
32350|NCT03143608|"~     The investigators prospectively studied ninety nine GERD patients following laparoscopic~     hiatal surgery combined with transoral incisionless fundoplication at two community~     hospitals. General surgeons and gastroenterologists participated in the study. GERD questions~     were recorded before and at six and twelve months.~   "
32358|NCT03143504|"~     Eczema is a chronic disease of the skin that is becoming more common worldwide for reasons~     unknown. Currently the best indicator that a baby will suffer from eczema is if either or~     both parents have the condition, although this is not always the case. The goal of this study~     is to find out if, from birth, the skin of babies who later go on to suffer from eczema~     develops differently to those who do not. By doing this the research team hope to detect~     early signs of the disease within the first year of life. Our researchers will ask 150~     families from the local Sheffield community to take part in a 1-year study.~      To monitor baby skin development, the investigators will carry out 3 simple procedures at the~     skin surface that pose no risk to the baby. These procedures will be performed on the arm and~     thigh, at birth, 4 weeks, and 12 months of age. In addition the investigators will ask~     parents to answer questionnaires and fill out diaries at specific time points throughout the~     year, to collect information on how they care for their baby's skin. By recording which~     babies go on to, and do not, develop eczema the investigators hope to: (1) better understand~     baby skin development from birth, (2) identify if these simple procedures can predict the~     development of eczema during the first 12 months of life, and (3) investigate environmental~     effects that may cause disease onset. In a medical era where the prevention of eczema is the~     long-term goal, it is hoped that this study will provide a new way to identify babies that~     may go on to develop eczema. This will allow healthcare professionals to offer specific skin~     care advice from birth, and empower parents to take measured action to help prevent the~     emergence of eczema in their baby.~   "
32359|NCT03143491|"~     This is a Phase 2, open-label, dose-rising study evaluating the safety, tolerability, and~     preliminary efficacy of three concentrations of SOR007 ointment (0.15%, 1.0%, and 2.0%)~     applied topically once per week for four weeks to the ectocervix of subjects with high grade~     cervical intraepithelial neoplasia (CIN).~   "
32360|NCT03143478|"~     About 150,000 people in the UK suffer a stroke each year and ~60% with moderate to severe~     stroke fail to recover arm or hand use. Stroke rehabilitation is increasingly home-based~     following early supported discharge (ESD) from hospital to facilitate self-management and~     avoid problems associated with prolonged hospital stays. There is strong evidence that~     intensive practice and re-education of normal movement is essential for functional motor~     recovery, hence the NHS guideline of 45 minutes therapy 5 days per week, but NHS Trusts have~     difficulty meeting this target due to cost and access to specialist therapists.~      An M-MARK Mk1 device that combines an Inertial Measurement Unit (IMU) with an~     Mechanomyography (MMG) sensor has been designed and laboratory tested. Novel signal~     processing techniques have been demonstrated that reduce problems of vibration artifacts and~     generate information on mechanical muscle activity and movement. The aim of the overall~     M-MARK project is to develop a low-cost wearable wireless device (Mk2) that patients can use~     independently at home while practicing standardised everyday activities to regain upper limb~     function. Mk2 M-MARK has now been developed in collaboration with therapists, patients and~     their carers. The system incorporates feedback, presented on a computer/tablet, as motivating~     visualisations of movement showing them if they have moved in the correct way. A separate~     interface has been developed for therapists, which offers a simple system to diagnose~     specific movement problems to inform clinical decision-making, monitor progress and thus~     increase efficiency of therapy.~      In phase 1 of this study, user requirements were assessed to inform the development of the~     Mk2 M-MARK for clinical use. Ten patients and carers were interviewed and 20 health~     professionals took part in two focus groups, from Portsmouth Hospitals NHS trust and North~     Bristol NHS Trust. The Mk2 system has now been developed, reliability demonstrated and~     iterative testing with stroke patients has ensured usability of the system.~      This phase of research will examine the clinical feasibility of using Mk2 M-MARK with stroke~     patients who are undergoing early supported discharge. All feasibility aspects of the~     wearable system will be assessed including usability and safety. Preliminary data on efficacy~     will be collected and a health economics analysis will be undertaken.~   "
32361|NCT03143465|"~     Migraine is a highly disabling disorder affecting 14% of the general population Worldwide and~     ranked as the 6th most debilitating disease worldwide by the WHO. One of the most fundamental~     questions of migraine, which remains to be elucidated, is the mechanism behind the generation~     of migraine attacks.~      We will use calcitonin gene-related peptide (CGRP) and sildenafil as pharmacological triggers~     of migraine, combined with advanced neuroimaging techniques, to investigate the attack~     initiating pathophysiology.~      Both substances have previously been administered to healthy participants and migraine~     without aura patients, inducing headache and migraine-like-attacks.~      We hope to contribute with novelty to the current understanding of the migraine~     pathophysiology and development of more efficient treatment of migraine.~   "
32362|NCT03143452|"~     This study aimed to compare the efficacy between 2% lidocaine gel vs 0.5% tetracaine eye drop~     as topical anesthesia in phacoemulsification~   "
32363|NCT03143439|"~     The Urban Institute—a nonprofit, nonpartisan research organization—is partnering with Rubicon~     Programs to conduct a rigorous evaluation of its Fathers Advancing Communities Together~     (FACT) program. FACT is a multi-faceted program designed to deliver responsible parenting,~     healthy relationships, and economic stability services on a voluntary basis to low-income~     fathers in Contra Costa County, California. Urban's evaluation comprised of three key~     components:~      The implementation evaluation will describe FACT program activities and services, including~     communication and coordination across partners, service delivery mechanisms, and whether and~     how participants and their families received comprehensive services. Urban will identify a~     logic model for the program and assess the barriers to and facilitators of program~     performance. The implementation evaluation will draw from interviews with program staff,~     partners, and stakeholders, as well as field observations, program and administrative data,~     and focus groups with FACT participants and their families.~      The outcome evaluation will build on the implementation evaluation to determine whether~     specific program components, their frequency, and their duration, are related to outcomes.~     Urban will conduct surveys of program participants at the time of their enrollment into the~     program and one year following their enrollment to explore how participants' self-reported~     attitudes on various domains are associated with economic self-sufficiency and family~     functioning. Urban will also use program and administrative data collected by Rubicon and its~     partners, specifically Rubicon's case management database, to assess participant outcomes.~      The impact evaluation will assess to what extent participation in the FACT program is~     associated with improved outcomes as compared to similarly situated individuals who did not~     participate in the program. Urban will work with Rubicon's partners to identify individuals~     living in Contra Costa County who were eligible to participate in the program but, for~     whatever reason, did not do so. Once a comparison group of fathers has been established,~     Urban will use individual-level outcome data to determine whether the FACT program has an~     impact on economic self-sufficiency and family functioning.~   "
32383|NCT03143179|"~     The immediate period after spinal cord injury (SCI) is one of the only opportunities that~     clinicians and care-givers have to make a real difference to patient outcomes. One of the~     main aims during this period is to preserve blood flow and oxygen delivery to the spinal cord~     to prevent any further damage from occurring after the injury. The heart acts as the major~     pump for blood to be pumped to the spinal cord and the body. It has been shown in small~     animal models and in humans with long-standing SCI that the ability of the heart to pump~     blood after injury is compromised, which may in turn reduce the amount of blood and oxygen~     delivered to the injured cord. It is unclear how quickly these changes occur in the heart~     following SCI and how best to manage heart function such that blood flow and oxygen delivery~     can be optimized. In the present study, the investigators will examine how the heart~     functions immediately after SCI. The findings from this study are expected to provide new~     information that could help clinicians improve the management of people who have just~     suffered a SCI.~   "
32364|NCT03143426|"~     Laparoscopic cholecystectomy (LC) is currently the most commonly performed major abdominal~     surgery in Western countries. Ever since the introduction of laparoscopic surgery in the late~     1980s, cholecystectomies are now routinely performed laparoscopically; concomitantly the~     introduction and refinement of other laparoscopic abdominal surgeries have rapidly progressed~     due to the early experience and safety profile seen in LC.~      The introduction of stereoscopes which allow for 3D visual feedback has been postulated to~     overcome setbacks encountered in conventional 2-dimensional (2D) laparoscopic surgery. Since~     its introduction in the mid-2000s, 3D visualisation has been proven to be advantageous over~     2D visualisation, especially so within the context of training junior surgeons in controlled,~     experimental settings. The body of evidence on benefits of 3D visualisation within the~     clinical setting, i.e. when applied on live patients in operating theatres, remains small and~     weak. The previous publications however did not extrapolate any potential benefits on~     patients' well-being in correlation to their reported benefits and neither did they explore~     any potential benefits in reducing operative complications.~      We decided to embark on a study to investigate any peri-operative advantage conferred on~     junior surgeons in performing LC using 3D visualisation as the majority of LCs in Sibu~     Hospital are carried out by junior surgeons.~   "
32365|NCT03143413|"~     Systemic sclerosis is an autoimmune connective tissue disease with undefined etiology and~     characterized by progressive fibrosis of the skin and major organs. Dry eyes and / or buccal~     syndrome is commonly reported in patients with systemic sclerosis. Goujerot-Sjogren syndrome~     is a chronic autoimmune disorder that is characterized by dryness of the eyes (xerophthalmia)~     and / or mouth (xerostomia). It may be primary or secondary to another connective tissue~     disease (such as lupus, rheumatoid arthritis or other). Several criteria have been validated~     to classify the SS but require a labial salivary gland biopsy, invasive act which~     complications can sometimes be reported (hematoma, lip sensory defect).~      Several scores based on the evaluation of the ultrasound homogeneity of the salivary glands~     were developed but no studies have evaluated ultrasound abnormalities of salivary glands in~     patients with systemic sclerosis.~   "
32366|NCT03143400|"~     The aim of this study is to assess the behavior of a model probiotic strain, Lactobacillus~     salivarius, in the digestive tract of healthy volunteers and of ileostomized patients,~     depending on its galenic form.~      Two classic forms will be tested (powder and pill). An innovative galenic form (pill with~     retarded release), developed to enhance intestinal viability and probiotic efficacy, will~     also be tested.~   "
32367|NCT03143387|"~     This study evaluates the patient 's discomfort when submitted to partial caries removal~     through the atraumatic restorative treatment compared to chemo-mechanical caries removal~     using Papacarie™ gel.~   "
32368|NCT03143374|"~     The purpose of this study is to measure the amount of a protein in the brain known as tau~     using an imaging procedure called Positron Emission Tomography (PET/CT). Tau has been shown~     to build up in the brains of patients with injury to brain cells, including Alzheimer's~     disease (AD), Parkinson's disease (PD), Lewy body disease (DLB) and Frontotemporal~     degeneration (FTD).~   "
32369|NCT03143361|"~     Traditional and transcatheter surgical treatments of severe aortic valve stenosis (SAVS) are~     increasing in parallel with the improved life-expectancy. Recent randomized trials (RCTs)~     reported comparable or non-inferior mortality with transcatheter treatments compared to~     traditional surgery. However, RCTs have the limitation of being a mirror of the predefined~     inclusion/exclusion criteria, without reflecting the real clinical world.~      Technological improvements have recently allowed the development of minimally invasive~     surgical accesses and the use of sutureless valves, but their impact on the clinical scenario~     is difficult to assess because of the monocentric design of published studies and limited~     sample-size. A prospective multicentre registry including all patients referred for a~     surgical treatment of SAVS (traditional, through full-sternotomy; minimally-invasive; or~     transcatheter; with both sutured and sutureless valves) will provide a real-world~     picture of available results of current surgical options, and will help to clarify the grey~     zones of current guidelines.~      E-AVR is a prospective observational open registry designed to collect all data from patients~     admitted for SAVS, with or without coronary artery disease, in 16 cardiac surgery Centres~     located in six countries (France, Germany, Italy, Spain, Switzerland, and United Kingdom).~     Patients will be enrolled over a 2-year period and followed-up for a minimum of 5 years to a~     maximum of 10 years after enrolment. Outcome definitions are concordant with VARC-2 criteria~     and established guidelines. Primary outcome is 5-year all-cause mortality. Secondary outcomes~     aim at establishing early 30-day all-cause and cardiovascular mortality, as well as major~     morbidity, and late cardio-vascular mortality, major morbidity, structural and~     non-structural valve complications, quality of life and echocardiographic results.~      The study protocol is approved by Local Ethics Committees. Any formal presentation or~     publication of data will be considered as a joint publication by the participating~     physician(s) and will follow the recommendations of the International Committee of Medical~     Journal Editors (ICMJE) for authorship.~   "
32370|NCT03143348|"~     This study evaluates the effect of heart-lung bypass on babies undergoing cardiac surgery.~     The investigators want to learn more about the inflammation that exposure to bypass creates~     in the body by studying markers of inflammation and cell injury in the bloodstream.~     Additionally, the investigators want to examine if these markers can predict which babies~     develop post-surgical complications. The hypothesis is that babies who undergo bypass will~     have higher levels of these markers than babies not exposed to bypass and that these markers~     will correlate with how the baby does clinically after surgery.~      This study will evaluate markers via blood sampling in babies with congenital heart disease~     who do not undergo cardiac surgery, those that undergo surgery without bypass, and those that~     undergo surgery with bypass. The overall goal is that this study will lead to useful~     biomarkers and lay the groundwork for future novel therapies aimed at improving outcomes for~     babies who require heart-lung bypass.~   "
32371|NCT03143335|"~     The purpose of this study is to examine different outcomes of breast reconstruction in women~     who are treated for breast cancer with skin sparing mastectomy and subsequently a primary~     implant based reconstruction by one of two different techniques with either a pre- or~     retropectoral placement of the implant.~      The main objective of the study is to establish whether one of these techniques may result in~     a superior outcome and thus should be recommended as first choice treatment rather than the~     other.~   "
32384|NCT03143166|"~     The primary objective of this trial is to investigate the relative Bioavailability [BA] of~     tablet formulation of Dabigatran etexilate [DE] with and without co-administration of~     rabeprazole in healthy male subjects.~      The secondary objective is the evaluation and comparison of several pharmacokinetic~     parameters between the treatments.~   "
32385|NCT03143153|"~     The main purpose of this study is to compare how long subjects with esophageal cancer live~     overall or live without disease progression after receiving nivolumab and ipilimumab or~     nivolumab combined with fluorouracil plus cisplatin versus fluorouracil plus cisplatin~   "
32372|NCT03143322|"~     Bone metastases occur frequently during the evolution of solid tumors, either isolated or~     associated with visceral metastases. The incidence varies between 20 and 85% depending on the~     primary cancer. Breast, prostate, and lung cancers are responsible for 70% of bone~     metastases. Cancer with bone metastases compared to other metastatic sites is considered as~     associated with a better prognosis, particularly for breast and prostate cancer. Bone~     metastases may be present at diagnosis (synchronous metastasis) or appear at a later time~     (metachronous metastasis).~      The concept of oligometastases was proposed in patients with about 3 up to 5 metastases~     (without restriction on the primary site) and associated with an intermediate prognosis. It~     was hypothesized that local treatment with curative intent, aiming at the few metastatic~     sites, would yield long-term survival probabilities, along with systemic therapies.~      Long-term survivors have been reported after curative-intent treatment of metastasis in~     sarcoma and colorectal cancers with liver or lung metastasis. We chose to focus on bone~     metastasis because of their high incidence, their impact on the patient's quality of life and~     autonomy, and their accessibility to potentially curative radiotherapy.~      The systemic treatment of metastatic cancer includes hormonal therapy (breast and prostate~     cancer), biologically-targeted drugs and chemotherapy (all cancers).~      Stereotactic radiotherapy is a highly accurate technique was initially developed for~     performing the radiosurgery of brain tumors in patients for whom it was deemed be too~     difficult to proceed to classical excision surgery. In this process, a high total dose of~     radiation is delivered in a single fraction to a well-defined intra-cranial target. The~     concept of radiotherapy in stereotactic conditions was extended to one or several fractions~     delivered to small volumes primary tumors/ metastases in extra-cranial sites (Stereotactic~     Body RadioTherapy [SBRT]). At present, high control rates have been achieved for lung~     metastases. Similarly, very high local control rates have been reported in bone metastases~     after stereotactic radiotherapy.~      In this protocol, our purpose is to demonstrate, via a randomized phase III trial, that high~     doses of radiotherapy, delivered in stereotactic conditions to the bone metastases (between 1~     and 3 metastases) in solid tumor patients is able to improve the survival without~     progression.~   "
32373|NCT03143309|"~     This study is a parallel group randomized controlled trial among female university students~     designed to test the effect of a physical activity intervention on daily walking. Both groups~     will receive messages 2-3 times per week via WhatsApp. Intervention group will receive~     orientation and wear a pedometer for the study period. The follow-up duration is 3 months.~   "
32374|NCT03143296|"~     The purpose of this study is to investigate speech understanding in simulated reverberant~     environments with MED-EL cochlear implant recipients.~   "
32375|NCT03143283|"~     The National Action Alliance to Prevent Suicide recently released a research agenda aimed at~     significantly reducing suicide over the next decade. Aspirational Goal 12, Reduce access to~     lethal means that people use to attempt suicide, calls for identifying effective strategies~     to reduce a suicidal person's access to firearms and other lethal means.~      A promising strategy is to counsel patients seen in the emergency department (ED) for a~     psychiatric emergency to reduce access to firearms (the most lethal suicide method) and~     medications (the most common method of suicide attempt). To date, however, few studies have~     evaluated changes in firearm storage practices among those who received lethal means~     counseling (LMC), and those that have, including a pilot conducted in Colorado by the study~     team, have lacked control groups. Results from the pilot, which provided emergency department~     based LMC counseling to parents of suicidal adolescents, found that among gun-owning parents,~     33% had unlocked guns at home on the day of the ED visit and none did on follow up.~      Using the piloted LMC protocol, we will conduct the first randomized, controlled trial (RCT)~     of the effectiveness of ED-based LMC on firearm and medication storage. The proposed RCT, to~     be conducted in five Colorado hospitals, will test whether parents of at-risk adolescents who~     are treated in hospitals that have (vs. have not yet) implemented our LMC protocol are more~     likely to store household firearms and medications safely. In addition, we will conduct~     in-depth, qualitative interviews with parents who have received LMC counseling to better~     understand those factors that affect parents' willingness and ability to make changes to~     firearm and medication storage. We will also conduct qualitative interviews with clinicians~     to understand factors affecting clinician engagement in LMC.~      AIM 1: To assess the effectiveness of an ED-based LMC intervention to improve how parents of~     pediatric patients (age 10-17) who visit the ED for a mental health emergency store household~     firearms and medication.~      AIM 2: To examine how attitudinal and contextual factors shape a) parents' decisions about~     firearm and medication storage following LMC, and b) clinicians' delivery of LMC messages.~   "
32376|NCT03143270|"~     The purpose of the study is to find out the effects of using nivolumab with Drug Eluting Bead~     Transarterial Chemoembolization (deb-TACE) in the treatment of liver cancer.~   "
32377|NCT03143257|"~     Study to accumulate post-market clinical evidence for the safety and effectiveness of the~     Sophono Alpha 2 and Alpha 2 MPO systems in subjects diagnosed with conductive hearing loss,~     single-sided deafness and mixed hearing loss who currently have or have had the Sophono~     implant.~   "
32378|NCT03143244|"~     To evaluate and compare the effect of administration of intravenous ketorolac- midazolam or~     dexmedetomidine as adjuvants to general anesthesia on perioperative outcome during retinal~     surgery.~   "
32379|NCT03143231|"~     Background: Bronchiolitis is one of the most common and costly respiratory diseases in~     infants and young children. Despite the high prevalence and morbidity of bronchiolitis,~     therapy remains controversial. Supportive care ensuring adequate hydration and oxygenation~     remains the cornerstone of therapy for these infants.~      Over the past 2 decades, research on bronchiolitis management has explored the use of~     nebulized hypertonic saline that rehydrate the airway surface liquid and improve mucociliary~     clearance, as well as reduce airway edema.~      Aim:The aim of this study is to investigate whether the addition of frequently nebulized~     hypertonic saline to standard therapy affects the length of stay (LOS) of moderately ill~     infants hospitalized with bronchiolitis.~   "
32380|NCT03143218|"~     A double-blind, individual randomised trial will be undertaken in 6000 children under the age~     of five years living in areas of Burkina Faso or Mali where the transmission of malaria is~     intense and highly seasonal to determine whether the malaria vaccine RTS,S/AS01 is (a) as~     effective as SMC with SP + AQ in preventing clinical malaria (b) provides additional, useful~     protection when given together with SMC. The primary trial end-point will be the incidence of~     clinical episodes of malaria detected by passive case detection. The costs of each~     intervention and its delivery will be determined and compared~   "
32381|NCT03143205|"~     This is a pilot study of a new 9-session individually delivered cognitive behavioral~     intervention targeting sexual minority stress. In this study, 40 HIV+ men sexual minority men~     will be recruited for the study then will be randomly assigned to either the new 9 session~     intervention or a writing task condition.~   "
32382|NCT03143192|"~     The goal of this pilot study is to investigate the safety and efficacy of micropulse (MP)~     macular laser in combination with intravitreal aflibercept for the treatment of~     centre-involved diabetic macular edema.~   "
32386|NCT03143140|"~     To evaluate a novel technique—ultrasound guided percutaneous abaltion of tumor feeding artery~     before RFA for liver malignancy.~   "
32387|NCT03143114|"~     The aim of this study is to evaluate the effect of myomectomy for intramural myomas on the~     fertility outcomes in infertile women.~   "
32388|NCT03143101|"~     This study is being conducted to compare the immunogenicity, safety, and viral shedding of a~     new A/H1N1 strain that will be incorporated into the FluMist quadrivalent formulation for the~     2017-2018 influenza season with the previous A/H1N1 strain that was included in the vaccine~     in the 2015-2016 influenza season.~   "
32496|NCT03141671|"~     This research study is comparing two different combinations of androgen deprivation therapy~     (ADT) used together with radiation as a treatment for rising PSA after radical prostatectomy~     (prostate cancer).~   "
32389|NCT03143088|"~     Obtaining vital signs and blood pressure (BP) in particularly, as part of a pediatric~     Emergency Department (ED) patient triage is sometimes difficult and leads to many false~     negative results.~      The stress, noisy environment and lack of cooperation are only a few of the things that~     interfere with a proper vital signs measurements.~      In the past decade, there has been a rapid growth in the presence of therapeutic clowns in~     hospitals, particularly in pediatric settings.~      we speculate that the incorporation of a medical clone during the procedure of blood pressure~     measurement in the triage will shorten the procedure and decrease the number of attempts,~     making it much more efficient.~   "
32390|NCT03143075|"~     In this study, the investigators will stratify depressed subjects a priori based on CRP~     levels to test the hypothesis that eicosapentaenoic (EPA) would be more efficacious to treat~     depression in subjects with high CRP levels compared to subjects with low CRP levels.~      Depressed subjects, with ongoing stabilized antidepressive treatment who remain clinically~     depressed, will be enrolled in an Inflammation group or in a Non-inflammation group~     depending on baseline levels of CRP. Subjects in both groups will receive EPA enriched~     omega-3 fatty acids for 8 weeks, added to their pre-stabilized antidepressant medication.~   "
32391|NCT03143062|"~     To this date no clinical evaluation reports of the dynamics in the National Early Warning~     Score (NEWS) for those patients who suffer an in-hospital cardiac arrest, IHCA, exists. This~     process needs to be investigated in order to optimize the future care of these patients.~      Research Questions H1: Patients that suffer an IHCA has had higher NEWS in the preceding 24~     hours from the event compared to those who did not suffer an IHCA.~      H2: There is a parameter in the NEWS that could predict IHCA better than the others in the~     preceding 24 hours.~   "
32392|NCT03143049|"~     Myeloma patients who relapse after prior treatment with bortezomib and lenalidomide have~     survival of less than 1 year. Recently, a randomized study of Pomalidomide and dexamethasone~     conducted in compared with placebo and dexamethasone showed that pomalidomide can improve~     survival of this group of patients. As a result, pomalidomide is now approved by the FDA and~     EMA for use in patients with relapsed/refractory myeloma previously treated with bortezomib~     and lenalidomide. We have conducted a study using Pomalidomide plus Dexamethasone (PD) in~     Asian patients, which showed good efficacy and safety profile. More important for patients~     with suboptimal response to PD will achieve a clinically meaningful response with the~     addition of oral cyclophosphamide (PCD). In the United States, a small randomised phase 2~     study of PCD versus PD showed that PCD have a higher response rates, produce deeper response~     and correspondingly longer progression free survival. There is till date no randomised phase~     3 study between these regimens. This will be important to determine what is the best~     combination including pomalidomide for use in relapse myeloma.~   "
32393|NCT03143036|"~     Myeloma patients who relapse after prior treatment with bortezomib and lenalidomide have~     survival of less than 1 year. A number of new drugs have been approved for the treatment of~     relapse myeloma in the last couple of years, including, Elotuzumab, Panobinostat, Ixazomib,~     carfilzomib and Pomalidomide. However, most of these drugs either do not have good single~     agent activity or still belongs to the category of immunomodulatory drugs or proteasome~     inhibitors. Daratumumab is a monoclonal antibody against CD38 that is highly expressed on~     myeloma plasma cells. In phase ½ studies, it has impressive single agent activity in relapse~     and refractory myeloma with a very acceptable toxicity profile. This set the stage for~     combinations with daratumumab to increase efficacy and improve outcome of patients with~     myeloma. The use of immunomodulatory drugs, such as thalidomide and lenalidomide, has been~     shown to augment NK cell activity. NK cells are important mediator of antibody dependent~     cellular cytotoxicity. We therefore hypothesize that the combination of Daratumumab with~     thalidomide may therefore improve the efficacy of the treatment.~      In this study, we will plan to perform a phase II trial using the Daratumumab, Thalidomide,~     Dexamethasone combination in 100 myeloma patients with relapse myeloma in Asia.~   "
32394|NCT03143023|"~     This study will be conducted to evaluate the effect of arginine versus fluoride containing~     toothpaste on neutralization of microbial acid produced by Cariogenic bacteria in adult~     population using chair side assessment method.~   "
32395|NCT03143010|"~     Small doses of dexmedetomidine1.5,3, 5µg used in combination with bupivacaine, in humans for~     spinal anesthesia has been shown to produce a more rapid onset of motor block, and a longer~     duration of motor and sensory block with preserved hemodynamic stability and lack of~     sedation.~   "
32396|NCT03142997|"~     This is an observational study to compare the effect of spontaneous ventilation versus~     controlled ventilation on lung atelectasis using lung score measured by lung ultrasound. the~     study will be conducted in children hospital of Cairo University Hospitals and study~     population will be : children aged from one to eight years of age. primary outcome will be~     the lung score measured by lung ultrasound.~   "
32397|NCT03142984|"~     The skin of a newborn has a sensitive skin barrier relative to an older child and an adult.~     Newborn's skin, for example, is extremely vulnerable to damage by environmental agents such~     as harsh detergents, some topical oils, and other irritant chemicals. Evolving perspectives~     on barrier dysfunction in newborn babies has led to the idea that there may be a window of~     opportunity in the first few months of a newborn's life to change the environmental agents~     that their skin is exposed to in order to maximize skin health. These environmental changes~     could involve the use of optimally formulated wash products and emollients, as well as the~     removal of all other irritant substances that could damage the skin barrier. Further research~     is required to identify skincare practices that are harmful and those that are positive, and~     to ultimately ascertain what the optimum skincare routine should be.~      An important skincare strategy is to identify an appropriate regimen (use of topical~     emollients and wash products) that will be used to maintain healthy skin in the future. Baby~     massage in particular has been shown to enhance the bond between mother and newborn,~     highlighting that early intervention can support skin health while also being a rewarding~     experience.~      Gentle Touch/Early Massage:~      Apply the lotion with a gentle touch to communicate love to your baby and to create a special~     bonding moment with skin-to-skin touch. Your touch nur-tures baby's social, emotional and~     physical development. Please take your time to apply consciously the lotion on the whole body~     of your baby while engaging with her/him. Your touch, light but present, will be consistent~     across all the face and body areas, it is delicate and soft but more than just applying the~     lotion.~      Parents/guardians are using products to help care for their newborn's skin and there is a~     need to help parents/guardians identify the most appropriate products through research. This~     study aims to help address this need.~   "
32398|NCT03142971|"~     The aim of this randomized controlled study is to investigate if focal shock wave is an~     effective treatment, with respect to hip pain and lower limb function, in a population~     affected by greater trochanteric pain syndrome with gluteal tendinopathy.~   "
32497|NCT03141658|"~     The purpose of this study is to evaluate the effects of TS-134 on ketamine-induced BOLD~     signals in ROIs in resting fMRI in healthy adult subjects.~   "
32400|NCT03142945|"~     In addition to manual therapy, mobilizations, manipulations, and exercise, the McKenzie~     method of Mechanical Diagnosis and Therapy (MDT) is currently being used to treat headaches.~     However, there is little supportive evidence about the efficacy of this type of treatment.~     The MDT method focuses on actively involving the patient in education and self-management of~     pain. The focus is to have the patient learn about his/her condition and how to manage the~     symptoms independently when possible.~      With regards to research that has been conducted on the use of MDT with headaches, one study~     compared mechanical traction, rhythmic impulse, and MDT exercises in relieving tension-type~     headaches (TTH). Mechanical cervical traction was found to be more effective at reducing~     headaches in both infrequent episodic and frequent episodic TTH. While MDT was used in this~     study, a general treatment was prescribed to each patient in that group without consideration~     to directional preference. This treatment had the patients perform the same exercises in the~     same progression, including four extension exercises, one flexion exercise, two lateral~     flexion exercise, and one rotation exercise. In addition, they performed the exercises for~     the same length of time for the same number of repetitions. The study was unclear about~     whether the exercises were administered by physical therapists or whether the practitioners~     were MDT credentialed.~      One case study described the treatment of a cervicogenic headache using the MDT retraction~     progression along with therapeutic exercises that included deep neck flexor and extensor~     strengthening and stretching of neck musculature as indicated . The patient reported that~     performing retractions at home provided him relief from his headaches for progressively~     longer periods of time as his treatment progressed. By the end of the treatment, the patient~     no longer experienced headaches. The results from this article support the proposition that~     headaches which present with mechanical origins can be successfully treated with the MDT~     approach.~   "
32401|NCT03142932|"~     The objective of this study is to conduct a randomized controlled trial to determine whether~     the use of the COach2Quit application (app) reduces smoking more than brief advice for~     smoking cessation. The investigators hypothesize that real time biomarker feedback and~     messaging support from the COach2Quit app will lead to greater smoking cessation rates than~     brief anti-smoking advice alone. If effective, the COach2Quit app could be an easily~     accessible and cost-effective tool to help smokers quit. The findings from this trial could~     have implications for the delivery of future outpatient smoking cessation programs.~   "
32402|NCT03142919|"~     LPS Challenge in Individuals with Major Depressive Disorder~   "
32403|NCT03142906|"~     The goal of this study is to assess the impact of perioperative point-of-care ultrasound~     (POCUS) assessment on patient-important outcomes (e.g. hospital length of stay, length of~     stay in recovery, mortality etc.) and perioperative patient management strategies, in~     patients undergoing non-elective non-cardiac surgeries.~   "
32404|NCT03142893|"~     The purpose of this study is to 1) determine how hypothalamic-pituitary-adrenal axis (HPA~     axis) activation occurs with sleep restriction 2) evaluate how hypothalamic-pituitary-gonadal~     axis (HPG axis) deactivation occurs with sleep restriction. The investigator will also~     examine the cognitive function associated with sleep restriction, including food intake and~     food cravings.~   "
32405|NCT03142880|"~     BACKGROUND: One previous study has confirmed that the marginally hyperbaric solutions of~     bupivacaine can maintain good quality of anesthesia and get a more steadily hemodynamic~     status than commonly hyperbaric solutions, some authors confirmed the plain ropivacaine for~     cesarean section have a higher failure rate and commonly hyperbaric solutions of ropivacaine~     have a higher incidence of side reaction. It is unclear what the efficacy of spinal~     marginally hyperbaric ropivacaine for elective cesarean delivery.We hypothesized that the~     marginally hyperbaric ropivacaine will get a similar efficacy to commonly hyperbaric~     solutions but a more steadily hemodynamic status.~      OBJECTIVE In this prospective, randomized, double-blinded study, Investigator will compare~     the clinical efficacy and adverse effect of spinal anesthesia with commonly hyperbaric and~     marginally hyperbaric ropivacaine for elective cesarean delivery.~      Main outcome measures: The maximum cephalad sensory block level; the change of continuous~     cerebral oxygen desaturation (ScO2) over time; the incidence of hypotension and nausea and~     vomiting; the change of invasive arterial pressure; the consumption of ephedrine; the~     incidence of shivering; the onset time to T8 dermatome; the quality of anesthesia (efficacy~     of motor block and sensory block)~   "
32406|NCT03142867|"~     Nonalcoholic fatty liver disease (NAFLD) is a global health concern with a suspected~     increasing prevalence due to the rise in obesity and diabetes mellitus. The vast majority of~     patients will have isolated steatosis or steatosis with mild inflammation that is very~     unlikely to progress in severity. However, about 25% of patients with NAFLD have~     non-alcoholic steatohepatitis (NASH), the more aggressive form of the disease that is~     associated with fibrosis progression and potential risk for cirrhosis and end-stage liver~     disease complications. Additionally, multiple studies have demonstrated an association~     between NAFLD and the presence of coronary artery disease by either coronary CT angiography~     (CCTA) or coronary artery calcium (CAC) score. Cardiovascular disease is the most important~     cause of mortality in patients with the entire spectrum of NAFLD. In the era of advanced~     imaging and functional vascular assessment it is possible that novel risk assessments are~     poised to refine overall prognostic estimation in this population. Multiple analyses have~     suggested that NAFLD is an independent and strong predictor of significant CAD independent of~     cardiovascular risk factors, including a significant burden of high risk CCTA findings in one~     analysis of symptomatic patients in the emergency department. Given the multiple metabolic~     derangements inherent in the NAFLD population, endothelial dysfunction is also an important~     contributor to global cardiovascular dysfunction. Furthermore, data suggests that patients~     with NAFLD may be at increased risk of adenomatous polyp formation and colorectal~     adenocarcinoma. In addition, it is suboptimal to require a liver biopsy to diagnose NASH.~     Recent imaging advances have made it possible to assess liver fibrosis but have yet to be~     fully studied in NAFLD. The purpose of this study is to assess the current prevalence and~     severity of NAFLD in adult subjects. Secondary endpoints include correlation to new vascular~     function (cine scan of the abdominal aorta) and echocardiographic imaging modalities~     available at BAMC and to circulating biomarker panels as well as to determine the prevalence~     and severity of CAD by multidetector coronary CT angiography with subject outcomes being~     monitored prospectively. Additionally, correlation of NAFLD diagnosis to colonoscopy findings~     will be performed.~   "
32407|NCT03142854|"~     About 30% of patients were reported to suffer inadequate bowel preparation. So, it is~     desirable to prescribe personalized regimen according to patient's personal characteristics.~   "
32408|NCT03142841|"~     This research study will test a problem-solving intervention for Spanish-speaking stroke~     caregivers that will be delivered over the telephone and online via the previously developed~     and nationally available Spanish version of the RESCUE website. The investigators will adapt~     their previously pilot-tested problem-solving intervention and make it culturally-relevant~     for Hispanic caregivers. The investigators' main goal is to test the efficacy of a brief,~     telephone and online problem-solving intervention. The objectives are: 1) reduce caregiver~     burden and depression, 2) improve caregivers' problem-solving abilities, self-efficacy, and~     quality of life, 3) improve Veterans' functional abilities and determine the intervention's~     impact on Veterans' healthcare utilization, 4) determine budgetary impact, and 5) determine~     caregivers' perceptions of the intervention.~   "
32409|NCT03142828|"~     The work hyposesis is based on the application of a chlorhexidine gel against the~     non-application on the healing abutments in patients who have received a submerged titanium~     implant to check its effect on healing and prevention of bacterial plaque accumulation during~     a period of 1 month.~   "
32410|NCT03142815|"~     This study will examine whether pre-operative, non-invasive arterial stiffness measurements~     can be used to predict which patients will develop an aortic-to-radial pressure gradient~     after coronary artery bypass graft (CABG) surgery. A previous small study by Kanazawa, et al.~     demonstrated in patients who developed an aortic-to-radial pressure gradient after CABG~     surgery, the pulse wave velocity (PWV) was higher in the aorta and decreased when moving~     toward the radial artery. In the patients who did not develop a pressure gradient, the PWV~     started lower in the aorta and increased when moving towards the periphery.~      The purpose of this investigation is to examine whether pre-operative PWV measurements can be~     used to identify patients who will develop an aortic to radial pressure gradient after CABG~     surgery.~      Applanation tonometry will be performed on the right carotid and femoral arteries to assess~     carotid-femoral pulse wave velocity, a surrogate for aortic stiffness. (SphygmoCor system,~     AtCor Medical, Sydney, Australia). The measurement will be obtained before induction of~     general anesthesia in the presurgical area. Also in the presurgical area, a non-invasive~     cardiac output (CO) measurement will be obtained by using the ICON Device (Osypka Medical, La~     Jolla, California). This CO value will be used to compare to the CO values obtained~     invasively in the operating room.~   "
32411|NCT03142802|"~     Patients with primary germ cell cancer of the testicles confined to the testis can avoid~     adjuvant treatment by entering a surveillance protocol. In the surveillance protocol,~     patients are followed for up to ten years with serial computed tomography scans to detect~     recurrence. Multiple CT scans expose patients to a significant amount of radiation, which may~     be associated with an increased risk of secondary malignancies. This study hypothesizes that~     low dose CT scans are as effective as standard dose CT scans in detecting disease recurrence~     in this setting and will significantly reduce radiation exposure in this group of patients.~   "
32412|NCT03142789|"~     In this study we wish to investigate the analgesic effect of the administration of 0.2%~     ropivacaine for an adductor canal block as repeated boluses (20 ml every 8 hours) through a~     new suture-method catheter or a standard perineural catheter compared with a single bolus (20~     ml), in patients following primary total knee arthroplasty.~   "
32413|NCT03142776|"~     To assess the local effect of the antimicrobial therapy using clarithromycin association with~     photodynamic therapy (PDT) in the treatment of generalized aggressive periodontitis (GAgP).~   "
32414|NCT03142763|"~     The objective of this study is to determine the effects of consuming either 3 eggs per day as~     compared to a daily choline supplement (choline bitartrate, 397.5 mg choline/day) on plasma~     concentrations of High Density Lipoprotein-cholesterol (HDL-C), trimethylamine N-oxide~     (TMAO), and other biomarkers of cardiovascular disease risk in young, healthy individuals.~     The goal is to determine if choline given as phosphatidylcholine (eggs) will lead to a~     different TMAO response when compared to choline in free supplemental form.~   "
32415|NCT03142750|"~     Gastrostomy tube (G-tube) complications, such as granulation tissue formation and tube~     dislodgements, are frequent causes of emergency department visits. The investigators have~     developed two G-tube dressing designs using commercially available materials and products to~     decrease the risk of G-tube related complications. The investigators aim in this study is to~     pilot two novel G-tube dressings in patients with pre-existing G-tubes to gain parental~     feedback on device designs, ease of use and G-tube stability in preparation for a final~     design and trial.~   "
32416|NCT03142737|"~     The investigators will determine effects of different sources of protein on whole-body net~     protein synthesis and muscle protein synthesis in young healthy participants.~   "
32417|NCT03142724|"~     The overall goal of this protocol is to evaluate the biodistribution of [18F]MNI-968 as a D1~     receptor targeted radiopharmaceutical.~   "
32418|NCT03142711|"~     Systemic lupus erythematosus (SLE) may involve a variety of organ systems expressed~     differently from patient to patient, and so can be difficult to characterize clinically.~     Patient reported outcomes (PROs), which consist of feedback directly from patients regarding~     their symptoms without interpretation by a clinician, are typically used in SLE to supplement~     other clinical measures. Standard PROs typically used in SLE include the 36-item short form~     health survey (SF-36), the functional assessment of chronic illness therapy - fatigue~     (FACIT-F), and the patient global assessment (PtGA), administered by paper or electronic~     tablet during the clinic visits. The recent development of electronic mobile device~     technology, such as the smartphone, has made it possible to collect PRO information away from~     the clinical site in the subject's environment. This study will assess by measurement~     equivalence testing whether data collected via a smartphone are comparable to that collected~     in standard fashion and whether PROs obtained in the subject's environment may be more~     informative than that collected in the physician's office on paper.~   "
32419|NCT03142698|"~     Evaluation of 4 MRI methods (PDFF 3, 6 and 11 gradient echoes and Spectroscopy) compared to~     the reference method (liver biopsy) in quantification of hepatic steatosis~   "
32420|NCT03142685|"~     To evaluate the feasibility of performing a randomized pilot control trial of two diagnostic~     screening strategies for necrotizing enterocolitis in patients with congenital heart disease.~     Measures to evaluate will be the ability to obtain consent from patients, percentage of~     eligible patients that are able to be recruited, coordination of providers, estimation of~     degree of crossover and ability to perform the screening exams per protocol.~   "
32421|NCT03142672|"~     The aim of this retrospective study was to compare immediate postoperative pain scores and~     the need for rescue analgesia in children who underwent pulpotomies and general restorative~     treatment and those who underwent general restorative treatment only, all under general~     anaesthesia.~   "
32422|NCT03142659|"~     The investigator is trying to improving our knowledge in the treatment of HF patients, for~     the purpose of improving their quality of life and reducing hospitalizations. For achieving~     this the investigator would like to build a registry which will include all the HF patients~     going an evaluation in the Heart Failure unit or clinic in our facility,~   "
32423|NCT03142646|"~     Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD19~     Chimeric Antigen Receptor to Patients With CD19+ B-cell leukemia or CD19+ B-all.~   "
32424|NCT03142633|"~     The aim of this study is to explore the microRNA profile in serum of women with Polycystic~     Ovary Syndrome and investigate the correlation between the microRNA profile and markers of~     metabolic syndrome.~   "
32425|NCT03142620|"~     Background:~      Helicobacter pylori infection, which affects over 50% of the global population, is one of the~     most prevalent infectious diseases in the world. H. pylori infection causes chronic active~     gastritis and is associated with peptic ulcer, lymphoma of the mucosa-associated lymphoid~     tissue and gastric cancer. The colonization of H. pylori in the hostile gastric environment~     is determined by the complex interactions among bacterial, environmental and host factors.~     Because of the emergence of antibiotic resistance and adverse drug reactions such as~     diarrhea, the successful rates with standard triple therapy for H. pylori eradication are~     falling.~      Vitamin D or its analogues was found to induce autophagy in keratinocytes, macrophages, and~     various cancer cell types. Our preliminary findings indicated that 1α,25-dihydroxyvitamin D3~     could induce cathelicidin expression and autophagy in cultured human gastric epithelial~     HFE-145 cells and reduced the intracellular survival of H. pylori in a co-culture system. It~     was also found that cathelicidin alone reduced the survival of drug-resistant strain of H.~     pylori. 1α,25-dihydroxyvitamin D3 also significantly reduced H. pylori colonization in mice,~     perhaps through the induction of cathelicidin in the stomach. These findings suggest that~     vitamin D not only could control H. pylori but also its drug-resistant strains in humans.~      Emerging evidence suggest that vitamin D might be a cost-effective prophylactic and possibly~     therapeutic antimicrobial agent for the control and eradication of H. pylori. Since vitamin D~     acts through mechanisms independent of standard antibiotics, it is expected that vitamin D~     will be equally efficacious for controlling and eradicating drug-resistant strains of H.~     pylori. The investigators herein propose that vitamin D in combination of standard~     antimicrobial therapeutics could improve the eradication rates of drug-resistant H. pylori.~   "
32426|NCT03142607|"~     Patient presenting to the dental clinic with gingivitis and fulfilling the inclusion criteria~     will be included in the study after taking informed consent. Participants will be divided~     into three groups. Each group will be instructed to apply metronidazole gel, chlorhexidine~     gel or combination of metronidazole and chlorhexidine gel on the marginal gingiva.~     Measurement for the gingival index will be taken at baseline, at 2 weeks and at 4 weeks~     interval~   "
32427|NCT03142568|"~     Describe the safety of sildenafil in premature infants at risk of bronchopulmonary dysplasia~     and determine preliminary effectiveness and pharmacokinetics (PK) of sildenafil. Funding~     Source - FDA OOPD.~   "
32428|NCT03142555|"~     Smoking causes cardiovascular and respiratory diseases, cancers and diabetes, and it has been~     a leading risk factor for death globally. Despite the availability of smoking cessation~     services locally, most smokers do not use such services. Workplace is one of the most~     convenient platforms to provide smoking cessation services and over 55% of smokers are~     employed according to the local population-based survey. However, the effectiveness of a~     smoking cessation programme conducted in workplace is yet to be examined in Hong Kong, and~     the attitudes and practices of corporations in promoting smoking cessation are not clear.~     Thus, this study aims to examine the employers'/managerial staff's knowledge, attitudes and~     practices in promoting smoking cessation in workplace and evaluate the smoking behaviours of~     participants before and after attending a smoking cessation intervention.~   "
32429|NCT03142542|"~     This study evaluates the efficacy and safety of Udenafil dosed once a day in patients with~     erectile dysfunction after bilateral nerve-sparing radical prostatectomy.~   "
32430|NCT03142529|"~     This study evaluates the clinical efficacy and study the therapeutic mechanism of a kind of~     traditional Chinese medicine colonic dialysis on Chronic kidney disease (CKD) 5 without blood~     dialysis therapy in adults. Half of participants will receive conventional integrated therapy~     on chronic renal failure (CRF), while the other half will receive integrated therapy on CRF~     and traditional Chinese medicine colonic dialysis.~   "
32431|NCT03142516|"~     To estimate progression-free survival at one year in elderly patients with RAS/BRAF wild-type~     unresectable mCRC and good performance status treated with FOLFIRI + panitumumab as~     first-line therapy.~      The clinical hypothesis of this study is that the combination of panitumumab and FOLFIRI is a~     good treatment option in elderly patients with good performance status and RAS/BRAF wild-type~     unresectable mCRC. Another purpose of this clinical trial is to determine the RAS/BRAF~     mutation status in liquid biopsies at baseline and at the time of disease progression.~   "
32432|NCT03142503|"~     Psoriasis (Ps) and psoriatic arthritis (PsA) are associated with increased risk of metabolic~     syndrome (MetS), body fatness and cardiovascular risk. Additionally, oxidative stress and~     inflammation are also contributing mechanisms on Ps and PsA. However, little is known about~     the influence of diet and micronutrients on the main outcomes of these diseases. The aim of~     the investigators is to evaluate the effectiveness of an intervention diet program on disease~     activity, metabolic profile and oxidative stress inpatients with Psoriasis and Psoriatic~     Arthritis.~   "
32433|NCT03142490|"~     This is an open-label randomized controlled trial of the use of acupuncture in infertile~     patients receiving In Vitro Fertilization (IVF). Patients will be randomized into two groups:~     treatment group will receive acupuncture as a complementary approach to IVF and control group~     will receive the IVF treatment. Groups will be compared with the World Health Organization~     quality of life (WHOQOL-Bref), short-form 36 (SF-36), State Trait Anxiety Inventory (STAI)~     and Scope-Stress questionnaires.~   "
32434|NCT03142477|"~     This is a randomized controlled prospective study on the use of therapeutic touch in patients~     diagnosed with gynecological cancer. The patients will be randomized into three groups:~     control group (will not receive any interventions with therapeutic touch), placebo group~     (will receive simulated therapeutic touch intervention by individual not knowing this~     technique) and treatment group(will receive therapeutic touch intervention by a trained~     therapeutic touch therapist). Two different quality of life questionnaires will be applied~     (before and after treatment). Levels of cortisol, salivary IgA, hematological indices and~     telomerase activity before and after the use of therapeutic touch will be compared between~     groups.~   "
32435|NCT03142464|"~     Perioperative intravenous fluid (IV) administration has been the standard procedure since~     1832 and, is a widely used practice sometimes under inadequate criteria. The present work~     aims at verifying the clinical need that justifies the common IV fluid prescription on the~     postoperative (PO) period in patients undergoing videolaparoscopic cholecystectomy (CVL)~     elective.~   "
32436|NCT03142451|"~     The Primary Objectives of FX2016-11 and FX2016-12 are to determine the efficacy and safety of~     FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of~     rosacea.~   "
32437|NCT03142438|"~     This investigation is a prospective, non randomized, non blinded study. This investigation is~     designed to evaluate the performance, comfort and ease of use with the F&P trial full face~     and nasal mask amongst Obstructive Sleep Apnea (OSA) patients. Up to 70 OSA patients will be~     recruited from the North Texas Lung and Sleep Clinic (NTLSC) database~   "
32438|NCT03142425|"~     Collect blood samples and associated clinical data prior to and post radiation treatment.~   "
32441|NCT03142386|"~     The aim of present study was to study the osteopathic manipulative effects on pain relief and~     quality of life improvement on hospitalized oncology geriatric patients. A non-randomized~     comparison trial was performed in Unit of Oncology Rehabilitation, Palazzolo Institute, Don~     Carlo Gnocchi Foundation ONLUS, Milan, Italy, from September 2015 to March 2016. 23 older~     oncology patients were unrolled and allocated in two experimental groups: study group (OMT~     group, N=12) underwent to osteopathic manipulative treatment associated to physiotherapy and~     control group (PT group, N = 11) underwent only physiotherapy. At enrollment (T0), 23~     recruited oncology patients completed the socio-demographic forms and were evaluated, from~     external examiner, pain intensity and quality of life. All patients were revaluated at the~     end of treatment (T4) for quality of life and every week (T1, T2, T3 and T4) for pain~     intensity. Standard level of significance was p<0.05.~   "
32442|NCT03142373|"~     Background. Heart rate variability (HRV) and skin conductance (SC) reflect autonomic activity~     and the balance of autonomic nervous system (ANS) which regulates involuntary physiological~     functions. The modulation of ANS tonic activity is a target of osteopathic manipulative~     treatment (OMT). The main aim of the present study was to verify whether CV4 and RR~     osteopathic techniques influence ANS activity, as measured by HRV and SC.~      Trial design. A randomized-controlled clinical trial was performed from June 2010 to January~     2011.~      Methods. 32 healthy adults (33.9±14 years, and 72% female) were selected. At enrollment, all~     subjects were randomized in three groups: CV4 group (CV4 technique), Rib Raising group (RR~     technique), and Placebo group (PL technique). Each subject of each group underwent respective~     technique only once. HRV and SC was continuously recorded during the session respectively~     with heart rate monitor Polar S810i and with Onda Scanner Domiana (OSD-Microsale model). All~     data analysis was performed using SPSS statistical software and the significance level was~     considered at p≤0.05.~   "
32443|NCT03142360|"~     There is no randomized control study to determine if the beneficial effects of beraprost~     sodium could improve the patency of arteriovenous fistula in hemodialysis patients.~     Therefore, this study is aimed to demonstrate the use of beraprost sodium can improve the~     patency of arteriovenous fistula in patients undergoing hemodialysis. This study is~     prospectively randomize controlled open-label trials in patients who newly made artificial~     arteriovenous fistula for hemodialysis. This study is a pilot study, and the target number of~     subjects is 60 in total, 30 in the treatment group and 30 in the control group.~      After randomization, the treatment group takes a beraprost sodium for 6 months and the~     control group does not take placebo.~      Treatment lasts for 6 months after dosing but continues until the patient changes the~     renal-replacement therapy method or falls under the exclusion criteria.~      The patient should visit at 1, 3, and 6 months after arteriovenous graft surgery to check the~     access site after graft surgery. The doppler ultrasound test is performed to measure the~     access blood flow rate and patency of arteriovenous fistula.~   "
32444|NCT03142347|"~     Comparison effectiveness two methods revascularization of the superficial femoral artery:~     remote endarterectomy vs. remote endarterectomy supplemented DCB angioplasty in patients with~     steno-occlusive lesion of the femoro-popliteal segment of TASCII D~   "
32445|NCT03142334|"~     The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475)~     in the adjuvant treatment of adult participants who have undergone nephrectomy and have~     intermediate-high risk, high risk, or M1 no evidence of disease (M1 NED) renal cell carcinoma~     (RCC) with clear cell component.~      The primary study hypothesis is that pembrolizumab is superior to placebo with respect to~     Disease-free Survival (DFS) as assessed by the Investigator in male and female participants~     with intermediate-high risk, high risk and M1 NED RCC.~   "
32446|NCT03142321|"~     The overall goal of the study is to develop data that can convincingly guide clinicians on~     the use and efficacy of vedolizumab in patients with small bowel CD. There is an unmet need~     to identify response to vedolizumab in small bowel CD using objective endpoints. Current data~     suggest that MR enterography may meet this unmet need. There is an additional unmet need to~     develop predictive models incorporating both clinical and baseline radiological and~     endoscopic variables with higher discriminatory performance in identifying longer term~     clinical remission with vedolizumab. Finally, this proposal is strengthened by the~     exploratory studies which may identify new proteomic biomarkers that correlate with longer~     term radiological response with vedolizumab reflecting its latency of response. If~     successful, these serum biomarkers may guide a personalized approach to the treatment of~     small bowel CD with vedolizumab, allowing early identification of PNR, monitoring disease~     activity and the pharmacodynamics of vedolizumab.~   "
32447|NCT03142308|"~     In Egypt, the evidence for quality processes has not been established yet in the current~     training programs for surgery residents. There are no published articles discussing career~     satisfaction among surgical residents. Therefore, we are going to conduct a self-designed~     survey in Egyptian university hospitals to measure residents' satisfaction and display views~     about their undergraduate surgical education, surgical education during internship year,~     post-graduate training program, and extracurricular activity during medical school.~   "
32448|NCT03142295|"~     The primary objective of this pilot study is to investigate the safety and tolerability of~     controlled human urine transfusion in female patients with recurrent UTI's.~      Seconday and exploratory objectives are to evaluate the diversity of the urine microbiome~     after urine transfusion, to assess the longevity of changes in the urine microbiome in~     patients after urine transfusion over a period of 6 months and to assess the frequency of~     UTI's after the transfusion.~   "
32449|NCT03142282|"~     This study is a randomized phase II trial of maintenance chemotherapy versus consolidative~     radiotherapy plus maintenance chemotherapy for patients with unresectable metastatic~     colorectal cancer (MCRC).~   "
32450|NCT03142269|"~     A prospective study included 20 patients with super high myopia who underwent bilateral~     uneventful cataract. 360°anterior capsule polishing was performed with double-ended capsule~     polisher randomly in one eye, and the opposite unpolished was used as the control. The~     refractive state and size of anterior opening were measured at postoperative 1 day as the~     baseline. Then they followed up at 1 month, 3 months and 6 months after surgery to record~     refractive state, higher-order aberrations, size of anterior opening, tilt and decentration~     of IOL (intraocular lenses)and PAD(postoperative aqueous depth). The paired t test was used~     to compare the differences between the two groups, and the same test the postoperative~     follow-up comparing with the baseline.~   "
32451|NCT03142256|"~     This study has two phases. It will be conducted in one site in CT only. Phase I is to~     enumerate interest in PrEP uptake among young South African women exposed to a~     culturally-appropriate social marketing campaign. This enumeration will also serve as a~     recruitment strategy for a cohort with open-label PrEP access in Phase II. The cohort will~     assess PrEP acceptability and adherence among 200 HIV-uninfected young women who are offered~     open-label daily oral PrEP and randomized to receive or not receive a short term cash~     incentive conditional on study drug adherence.~   "
32452|NCT03142243|"~     Humans generally develop a preferred upper and lower extremity. Due to repetitive uneven~     loading, this gradually results in morphological adaptations to the dominant side of the~     body. The corresponding morphological asymmetry can be further accentuated by (intensively)~     practicing a unilateral sport such as tennis, which is very popular. Yet, research on this~     particular topic is scarce, especially in (elite) female players. Furthermore, existing~     studies only examine the degree of morphological asymmetry of the upper extremity. Therefore,~     the aim of this study is to explore the morphological differences between the dominant and~     the non-dominant extremity/side on a whole body level (trunk, upper and lower extremity) in~     elite female tennis players.~   "
32453|NCT03142230|"~     Subject of research : Evaluation of a technique of care to reduce the pain caused by the~     laying of the gastric tube in the newborn~   "
32454|NCT03142217|"~     Huntington's disease is a hereditary disease of rare autosomal dominant transmission, both~     neurodegenerative and neuro-psychiatric. Clinically, there are motor symptoms (chorea),~     cognitive disorders (dementia) and psychiatric disorders.~      Among motor disorders, dysarthria is a commonly found symptom. This is classically referred~     to as hyperkinetic dysarthria according to the criteria of Darley's classification. However,~     this old classification (1969) is only based on perceptual analysis and lack of specificity.~      Moreover, in the course of the disease, chorea (control of the striatal attack D2) decreases~     to give place to a parkinsonian syndrome (control of the striatal attack D1) and the~     dysarthria also evolves towards a hypokinetic form . It also seems likely that cerebellar~     involvement (responsible for ataxia) contributes to dysarthria.~      No studies have been published to date to characterize dysarthria in Huntington's disease in~     a quantified, objective and specific manner. However, Canan Ozsancak describes choreic~     dysarthria as heterogeneous according to the patients and variable according to the~     productions. A perceptual study reports an imprecision of the consonants, a lengthening of~     the pauses, a variable flow, an absence of modulation of the pitch and a hoarse voice.~      Finally, few patients are cared for in speech therapy and there is no specific rehabilitation~     strategy: this would require - and justify a more precise study of the dysarthria of these~     patients.~      The Clinical Evaluation of Dysarthria developed by Pascal Auzou and Véronique~     Rolland-Monnoury is a recent and partially standardized tool, combining qualitative and~     quantitative evaluation, which seems adapted to try to better characterize the dysarthria in~     Huntington's disease.~   "
32455|NCT03142204|"~     This is a Phase 1 study is to visualize biodistribution of a PET tracer called [18F]F-AraG~     (VisAcT) in cancer patients expected to undergo immunotherapy.~   "
32456|NCT03142191|"~     This is a Phase 2, multicenter, multinational, randomized, double-blind, placebo-controlled~     study evaluating the efficacy, safety, pharmacokinetics (PK), quality of life and exploratory~     pharmacodynamics (PD) of two treatment doses of CC-90001, 200 mg and 400 mg, compared with~     placebo, when delivered once daily per os (PO) in subjects with idiopathic pulmonary fibrosis~     (IPF). This study is designed to assess response to treatment by using measures of lung~     function, disease progression, fibrosis on radiography, and patient-reported outcomes. It~     will also assess dose response.~   "
32457|NCT03142178|"~     A double-blind, placebo-controlled, randomized dose ranging study for the use of 3VM1001~     Cream, 2g three times daily, 3g three times daily, or 3g four times daily for treatment of~     chronic pain associated with osteoarthritis of the knee compared to inactive placebo.~   "
32458|NCT03142165|"~     The purpose of this study is to assess the safety and tolerability of BMS-986263 in healthy~     volunteers.~   "
32459|NCT03142152|"~     The objective of this prospective, multi-center, randomized, double-blind trial is to assess~     the safety and efficacy of the CARILLON Mitral Contour System in treating subjects with~     functional mitral regurgitation (FMR) associated with heart failure, compared to a randomized~     Control group which is medically managed according to heart failure guidelines.~   "
32460|NCT03142139|"~     It has been found that the non-live vaccine against Diphtheria, Tetanus, and Pertussis (DTP)~     in addition to its disease specific effects may have so called non-specific effects with~     the potential to affect sensitivity towards vaccine unrelated pathogens, resulting in excess~     mortality(Aaby, Kollmann, & Benn, 2014).~      A recent study from Australia found that delayed vaccination with the first dose of~     Diphtheria, Tetanus, and acellular Pertussis(DTaP)-containing vaccine is associated with~     reduced risk of atopic dermatitis (aOR: 0.57; 95% CI: 0.34-0.97, P = 0.04) and reduced use of~     medication against atopic dermatitis (aOR: 0.45; 95% CI: 0.24-0.83, P = 0.01)(Kiraly et al.,~     2016).~      This register based observational study aims to extend the existing knowledge on non-specific~     effects of non-live vaccines by testing the above finding, that delayed vaccination with~     Diphtheria, Tetanus, acellular Pertussis - Inactivated Polio vaccine - Haemophilus influenzae~     type b (DTaP-IPV-Hib) is associated with lower risk of developing atopic dermatitis before 1~     year of age in the Danish birth cohorts from 1997-2012.~   "
32461|NCT03142126|"~     The researchers are seeking to study whether or not there is benefit in keeping patients flat~     after Angioseal for extended periods of time after diagnostic heart catheterization or if a~     more aggressive approach of early ambulation would be just as safe while improving cost and~     patient comfort.~   "
32462|NCT03142113|"~     This retrospective multi-centric Belgian observational trial will involve all patients who~     have initiated adalimumab for moderate-to-severe ulcerative colitis prior to September 1st~     2015 in a Belgian centre maintaining a prospective log of patients using biological therapy.~      Only patients fulfilling all Belgian reimbursement criteria for adalimumab will be included,~     namely having failed mesalamine and steroids or thiopurine analogues for at least 3 months,~     or being intolerant to this therapy, and showing a total Mayo score of at least 6 with an~     endoscopic sub-score of at least 2.~      Both short-term and long-term outcome of adalimumab therapy will be evaluated, focusing on~     the need and successfulness of adalimumab dose-escalation from 40mg every other week to 40mg~     every week, and dose de-escalation back to 40mg every other week.~   "
32463|NCT03142100|"~     Introduction: Bilateral-bimodal users may benefit from bilateral-binaural and a bimodal~     effect . The two modes of stimulation complement each other and may overcome the limitation~     of electric hearing alone. However, alongside the expected benefits of having two hearing~     systems in bilateral bimodal hearing, there are several inherent mismatches in combing two~     different stimulation methods, which may negatively impact the processing of the binaural~     cues.~      Aim: To determine whether bimodal listening with a hearing aid programmed using a dedicated~     bimodal fitting formula, which aligns the frequency response, loudness growth functions, and~     automatic gain control (AGC) characteristics between the cochlear implant speech processor~     and the hearing aid brings additional benefit over bimodal listening with the subject's~     clinical hearing instrument via the use of using a comprehensive battery of speech perception~     tests aimed at different aspects of binaural hearing as well as the contribution of the~     unique bimodal complementary effect. A secondary goal is to identify the tests that are best~     suited to predicting and evaluating bimodal benefit.~      Method: The study will include 20 Hebrew and 20 Arabic speakers' adult bilateral-bimodal~     users that their audiometric thresholds in the non implanted ear will be no worse than 75 dB~     HL at 250 and 85 dB HL at 500 Hz, who use their hearing aids for at least 75% of their waking~     hours. The added benefit of the hearing aid programmed using a dedicated bimodal fitting~     formula will be evaluated using six task-specific tests designed to sensitively assess the~     bilateral-binaural and bimodal complementary effects using roving speech and noise and~     different types of background noises (maskers), pitch-related task and subjective~     questionnaire. Participants will be tested twice in quick succession, at two-weekly~     intervals, in establishing a baseline score with their clinical HAs. Then participants will~     be tested again twice in quick succession, at two-weekly intervals following three month~     experience with the HA fitted with the bimodal fitting formula. All tests will be~     administered the CI/HA listening condition.~   "
32464|NCT03142087|"~     30 patients with brain tumor will be included in the study between the ages of 6 and 18 who~     have undergone surgery. Patients included in the study will be randomly assigned to two~     groups. The study group will be included in the Nintendo Wii Fit Plus Balance Game exercise~     program under the supervision of a physiotherapist for 2 days per week for 8 weeks. The~     control group will be taken to the conventional exercise program under the supervision of a~     physiotherapist for 2 days a week, 1 hour a day. The assessments will be made before the~     exercise program begins and at the end of the 8th week. Patients' physical measurements were~     assessed by anthropometric evaluations, muscle strength measurement, pain Visual Analogue~     Scale, walking Observational Walking Analysis, Balanced Pediatric Functional Range Test,~     Timed Up and Go (TUG) and one foot standing test and Nintendo Wii Fit Plus Balance~     Assessment, Functional capacity 2 min. With Walking Test, fatigue with PedsQL~     Multidimensional Fatigue Scale, daily life activities will be evaluated with WeeFIM.~   "
32465|NCT03142074|"~     An aortic aneurysm (thoracic or abdominal) is a permanent dilatation of the aorta caused by~     weakening in the arterial wall. The feared complication is aortic rupture or dissection,~     leading to potentially lethal aortic bleeding and associated with mortality rates up to 95%.~     The current diagnosis criteria do not suffice, therefore the goal of this study is the~     development of an improved biomechanics-based and microstructural-based diagnostic tool.~   "
32466|NCT03142061|"~     Electrochemotherapy (ECT) with Bleomycin in non-operable advanced vulva carcinoma~   "
32467|NCT03142048|"~     Background:~      The proportion of elderly people has dramatically increased in recent decades. Moreover,~     social and demographic trends show a global increase of elderly people at risk of loneliness~     and lack of social relationships. The objective of this study was to evaluate the process,~     the effectiveness and the cost-effectiveness of an intervention to reduce social isolation~     and its negative effects on health in elderly persons.~      Methods:~      This is a mixed methods multi-approach evaluation that includes: 1) A qualitative evaluation~     among coordinators and participants taking part in the intervention, through in~     depth-interviews and focus groups, respectively. The main topics covered will be positive and~     negative aspects of the intervention, suggestions for its improvement, opinions on different~     aspects of the intervention, and perceived benefits. 2) A quantitative quasi-experimental~     design, comparing a group of individuals taking part in the intervention with another group~     with similar characteristics not receiving the intervention. Data will be collected at the~     beginning and at the end of the intervention. Social support will be measured through~     questions drawn from the Medical Outcomes Study and the National Social Life, Health, and~     Aging Project questionnaires. Psychological morbidity will be measured through Goldberg's~     General Health Questionnaire, and Health-related Quality of Life will be measured through the~     EuroQoL questionnaire. Information on visits to the primary care center in the years before~     and after the intervention will be obtained from the electronic records of the primary care~     centers. 3) A cost-utility analysis, conducted from a health system (primary care)~     perspective, including direct costs of the program and the primary care health services used.~     The effects of the intervention will be measured on quality-adjusted life years.~      Discussion:~      There is an urgent need for studies assessing the effectiveness and the efficiency of~     potential interventions to reduce social isolation among elderly persons. The results of this~     study will help to fill the knowledge gap in this area and might be especially useful for the~     development of social and public health policies and programs for older people in~     disadvantaged neighborhoods in urban areas.~   "
32468|NCT03142035|"~     Endometriosis is a chronic gynecologic disease that affects approximately 10% of women in the~     reproductive age group . It is characterized by the presence of endometrial tissue outside~     the uterus, causing pelvic pain and subfertility. It is estimated that around 40% of~     infertile women have the diagnosis of endometriosis . Infertility secondary to endometriosis~     is thought to be multifactorial. Women with endometriosis often require in vitro~     fertilization (IVF). One medical intervention that has been shown to improve IVF outcomes in~     women with endometriosis is hormonal suppression with gonadotropic releasing hormone agonist~     (GnRH-a) for a period of 3 to 6 months .~      In recent years, the effectiveness of dienogest, a fourth-generation progestin, for~     endometriosis treatment has been demonstrated. Dienogest seems to be as effective as GnRH-a~     in improving endometriosis-related pelvic pain [4]. However, no study has yet assessed~     whether dienogest has any benefit in treating endometriosis associated infertility.~      The aim of our study is to evaluate the efficacy of dienogest versus GnRH-a in improving~     ongoing pregnancy rates in women undergoing IVF due to endometriosis. We will conduct a~     non-blinded randomized controlled trial. One group will receive dienogest 2mg daily for a~     period of 3 months followed by a standard IVF/Intracytoplasmic Sperm Injection (ICSI) cycle.~     The second group will receive one injection of 3.75mg of GnRH-a every 28 days for three doses~     followed by a standard IVF/ICSI cycle 3 months later. The third group will not receive any~     medical interventions before the planned IVF/ICSI cycle. We hypothesize that patients~     receiving dienogest will have similar ongoing pregnancy rates compared to patients receiving~     the GnRH-a injection. Secondary outcomes including number of gonadotropins consumed, number~     of stimulation days, number of metaphase II eggs retrieved, fertilization rate, embryo~     quality, miscarriage rate, clinical pregnancy rates, live birth rates and potential maternal~     and obstetrical complications will also be evaluated. We will also compare ongoing pregnancy~     rates between the groups receiving Dienogest and placebo, and GnRH agonist and placebo.~   "
32469|NCT03142022|"~     Sleep-disordered breathing (SDB) describes a group of disorders in which partial or complete~     cessation of breathing occurs many times throughout the night, resulting in daytime~     sleepiness or fatigue that interferes with a person's ability to function and reduces quality~     of life. Transplantation has become an important treatment modality for end-stage organ~     failure. Transplant recipients are now living longer and, hence, develop chronic adverse~     medical conditions. Furthermore, transplantation is associated with weight gain. Despite the~     high prevalence of poor sleep and cardiovascular conditions among transplant patients, SDB is~     not well studied in these patients.~   "
32481|NCT03141866|"~     This trial will take the form of a feasibility study; designed to assess the feasibility of a~     proposed future clinical trial in this setting. This proposed future clinical trial is~     proposed to assess the impact of physical activity, in the form of specialised chair based~     physical activity interventions, on the physiological, psychological, cognitive, social and~     emotional health, and functional capacity of geriatric populations with pre-existing frailty~     within a clinical hospital ward setting; recognising health as a holistic concept~     incorporating a multitude of inter-related dimensions. This feasibility study is~     single-centre (taking place in the Harborne Ward of the Queen Elizabeth Hospital Birmingham,~     Mindelsohn Way, Edgbaston, Birmingham, United Kingdom).~   "
32470|NCT03142009|"~     This is a five-year R01 effectiveness trial where tribal partners are committed to assessing~     the Family Listening/Circle Program's effectiveness and disseminating the approach and~     intervention within Indian Country as a best practice in reducing substance abuse health~     disparities.Three specific aims of the grant are 1) To rigorously test effectiveness of FLCP;~     with a comparative longitudinal design within and across the tribes, with 4th graders to~     prevent substance initiation/use and strengthen families; 2) Through CBPR, support TRTs to~     transform their research capacities into local prevention research infrastructures and~     partnering; 3)To assess additional program effects on other health/education programs and~     leadership within the tribes. In sum, this multi-tribal/academic partnership builds on~     accomplishments to test the effectiveness of an innovative intervention. This grant provides~     an unparalleled opportunity to reduce substance abuse in three tribal communities, strengthen~     tribal research capacities, and impact substance abuse prevention research designs~     nationally, by illustrating how CBPR processes can integrate evidence-based and~     cultural-centered practices to create effective programs that generate community ownership~     and sustainability.~   "
32471|NCT03141996|"~     This study will measure if five minutes of vibration to the upper back neck muscles, prior to~     standard of care treatment, will improve symptoms of spatial neglect and/or activities of~     daily living function for patients who have had a stroke.~   "
32472|NCT03141983|"~     Anti-Cytokine Therapy for Hemodialysis InflammatION (ACTION) is a phase II multi-center study~     to evaluate the safety and tolerability of anakinra, an IL-1 receptor antagonist, for~     patients treated with maintenance hemodialysis.~   "
32473|NCT03141970|"~     This study is a multicentric, randomized, parallel group, open label controlled trial of~     children age 1 year up to 4 years with new onset, idiopathic nephrotic syndrome. It is~     designed to test the initial duration of steroid therapy of either 3 month or 6 month total~     duration. Participants will be randomized to either extend their pre-trial 3 months (12~     weeks) of standard of care corticosteroid therapy to add an additional 12 weeks of therapy or~     to stop therapy. Pre-trial standard of care corticosteroids will include 60 mg/m2/day for 6~     weeks followed by 40 mg/m2/day every other day for 6 weeks of prednisolone or equivalent. The~     trial intervention will therefore be an additional 12 vs 0 weeks of corticosteroids in these~     children with idiopathic nephrotic syndrome.~   "
32474|NCT03141957|"~     Aging and cancer are two conditions associated with extensive metabolic changes that can~     cause malnutrition. However, the clinical features and the underlying mechanisms leading to~     malnutrition are different in these two cases. We therefore wonder how age can influence the~     metabolic response to cancer.~   "
32475|NCT03141944|"~     The objective of this study is to describe the evolution of hypodopaminergic syndrome in~     patients with Parkinson's disease.~   "
32476|NCT03141931|"~     The aim of this study is to compare ocular symptoms and signs when Lacritec nutraceutical~     formulation (combination of flaxseed oil, borage oil and fish oil omega-3 fatty acids) is~     consumed daily over a 3 month period, with a control capsule that contains polyethylene~     glycol (PEG), oleic acid and propylene glycol, which are found in many pharmaceutical~     products and are generally considered to be biologically inert and safe. There is good~     evidence that the consumption of oily fish has a protective effect against dry eye, and other~     studies have provided evidence of the beneficial effect of supplementation with omega-3~     essential fatty acids in the treatment of dry eye disease. However, there have been limited~     well designed clinical trials investigating the potential for nutraceutical dietary~     supplementation to impact ocular comfort. To date, no controlled, randomised clinical trials~     have been conducted to evaluate the Lacritec nutraceutical formulation, which is an wholly~     Australian owned product. Therefore, the purpose of this study is to conduct a randomized,~     placebo-controlled, double-masked study to investigate the effects of dietary supplementation~     with a combination of flaxseed oil, borage oil and fish oil omega-3 fatty acids on ocular~     comfort including signs and symptoms of dry eye.~   "
32477|NCT03141918|"~     Among the many changes associated with the impact of HIV and the long-term use of~     antiretroviral therapy, metabolics are important because they are important risk factors for~     the development of cardiovascular diseases. The objective of the present study is to evaluate~     the effect of the supplementation of two bioactive compounds, curcumin and~     epigallocatechin-3-gallate, on the oxidation of resting energetic substrates in HIV / AIDS~     patients. The sample will be composed of adults living with HIV / AIDS on antiretroviral~     therapy for at least 6 months. Supplements will be made separately for 30 days and will be~     evaluated before and after the intervention the following parameters: body composition,~     energy metabolism, biochemical parameters and a structured anamnesis. Food consumption and~     the level of physical activity of the volunteers will be controlled.~   "
32478|NCT03141905|"~     The benefits of renin angiotensin system (RAS) blockers and diuretics for blood pressure~     control are well-established in chronic kidney diseases (CKD) patients; however, these agents~     may become hazardous on sick-days that lead to volume depletion (dehydration), and increase~     the risk of kidney function loss and acute kidney injury (AKI). It is not known how frequent~     significant sick-days occur in CKD patients, or whether a patient self-managed Sick-Day~     Protocol (SDP) that temporarily holds RAS blocker, diuretics, or other high risk medication~     in an effort to preserve renal function, or prevent AKI. The purpose of the study is to asses~     if a SDP, monitored remotely with a weekly automated phone survey , can improve outcomes in~     CKD (such as slow renal function loss and AKI episodes) and reduce preventable service~     utilization versus usual care.~   "
32479|NCT03141892|"~     This is a pivotal, non-randomized, single arm, multi-center, prospective, non-significant~     risk study to evaluate the FreeStyle Libre Flash Glucose Monitoring System.~   "
32480|NCT03141879|"~     This trial will take the form of a feasibility study; designed to assess the feasibility of a~     proposed future clinical trial in this setting. This proposed future clinical trial is~     proposed to assess the impact of physical activity, in the form of specialised chair based~     physical activity intervention, on the physiological, psychological, cognitive, social and~     emotional health, and functional capacity of geriatric populations with pre-existing frailty~     within a residential care setting; recognising health as a holistic concept incorporating a~     multitude of inter-related dimensions. This feasibility study is single-centre (taking place~     in the Ryland View BUPA care home, Arnhem Way, Tipton, United Kingdom DY4 7HR).~   "
32482|NCT03141853|"~     A study will be conducted to assess if adults and older adults with arthritis who ride horses~     are able to move better, have less pain, enjoy nature more and have a better quality of life~     then people who go to class to learn about exercise. This is needed because adults with~     arthritis experience joint pain, stiffness, damage to their cartilage, and decreased range of~     motion in their hips, knees, shoulders, and back. This study will measure effects on~     patient's joints, pain, quality of life, muscle and cartilage before and after either~     arthritis exercise education or horse riding. Horses have unique movements that target joints~     without weight bearing and possibly show improvements without joint damage.~      Twenty two subjects will be assigned to either the equine-assisted therapy (EAT) group or a~     group receiving exercise education for 1 hour each week for 6 weeks. Outcomes of pain, joint~     mobility and quality of life are measured at 0, 3 and 6 weeks. Enjoyment will be determined~     by a survey. Safety procedures include helmets, side walking attendants for balance, and~     controlled by a certified riding instructor at a certified riding center. Data will be~     gathered and reviewed, to assess the effects of EAT on arthritis.~   "
32483|NCT03141840|"~     This clinical trial seeks to investigate if an experimental medical device, ABL01, can be~     used to treat onychomycosis. In a 1-year trial the effectiveness of ABL01 will be tested~     against placebo in 70 study subjects with onychomycosis of the big toe nail. The endpoint of~     the trial is clinical improvement and cure at the 6 and 12 month time-point.~   "
32484|NCT03141827|"~     This study compares the effect of insulin given as a nasal spray with a placebo. Insulin is a~     chemical messenger (hormone) in the body that controls fat (triglyceride) levels in the blood~     by controlling the amount of fat made by the liver and gut. Recent research suggests that~     insulin may work through the brain. The investigators hypothesize that preferential delivery~     of insulin into the brain, through nasal spray of the hormone, may affect the amount of fats~     made by the liver and gut.~   "
32485|NCT03141814|"~     Asthma is characterized by chronic airway inflammation of the large and small airways. Asthma~     patients often have episodes with symptoms of dyspnea, wheezing and nocturnal awakening.~     Currently available inhaled anti-inflammatory treatments reduce the airway inflammation and~     treatment but do not cure the disease. Therefore asthma patients often need life-long~     treatment to control their asthma.~      In a small subset of patients, their asthma resolves spontaneously. This phenomenon is called~     asthma remission. Subjects with asthma remission do not experience symptoms or signs of~     airway inflammation anymore and do not require inhaled treatments. Some subjects with asthma~     remission also have a completely normal lung function without signs of bronchial~     hyperresponsivess: they have complete asthma remission. Unfortunately, asthma remission~     occurs only in a small subset of 15-25% of asthma patients.Objective: to determine the~     underlying mechanisms and molecular events leading to remission of asthma.~   "
32486|NCT03141801|"~     Quadriceps muscle weakness is a common consequence following anterior cruciate ligament (ACL)~     injury and reconstruction. Maximizing quadriceps strength following ACL injury is significant~     as diminished quadriceps strength has been linked to the osteoarthritis that affects over 50%~     of surgically reconstructed limbs. Given that knee joint health following ACL injury is~     predicated on restoring quadriceps strength, identifying treatment approaches capable of~     improving strength is paramount. Blood flow restriction training (BFRT) is a method where~     oxygen to the muscle is intentionally reduced during exercise/rehabilitation and may lead to~     more timely and substantial strength gains. In the proposed project, we will examine the~     efficacy of BFRT in patients who have undergone ACL reconstruction and suffer from~     substantial quadriceps weakness.~   "
32487|NCT03141788|"~     The objective of this study is to evaluate the efficacy of Clear Aligners to correct tooth~     malocclusions with the use of attachments and/or buttons, as determined by the amount of~     teeth movement and overall achievement goals of the treatment plan.~   "
32488|NCT03141775|"~     IBIS is a prospective, observational study, which aims to assess the cost of CDI per day,~     hospitalization and year including description of incremental costs in hospitalized patients,~     and recurrent episodes, in German hospitals. Exposure to CDI drugs will not be influenced and~     remains at the discretion of the treating physician.~      In addition to treatment, Health-related quality of life (HRQL) will be analyzed using~     standardized questionnaires.~   "
32489|NCT03141762|"~     Understanding the Impact of Critical Illness on Falls Risk - a 12 Month Observational Study~   "
32490|NCT03141749|"~     The risk for venous thromboembolism (VTE) in DM1 and in other inherited myopathies, which can~     lead to chronic immobilization, are unknown. The purpose of this study is to evaluate~     incidence of VTE in cohort of patients presenting with DM1 with a comparison to a group of~     other inheritable myopathies and to a community-based population.~   "
32491|NCT03141736|"~     The purpose of this study is to determine whether the combination of Kangaroo Mother Care~     (KMC) as continuously as possible together with the use of a plastic bag in combination with~     routine World Health Organization (WHO) thermoregulation care reduces the incidence of~     moderate (32-36° C) or severe (<32.0° C) hypothermia in preterm infants ≥ 32 to 36 6/7 weeks~     of gestational age (GA) when compared to KMC as continuously as possible together with~     routine WHO thermoregulation care.~   "
32492|NCT03141723|"~     The purpose of this study is to determine whether the combination of Kangaroo Mother Care~     (KMC) as continuously as possible together with the use of a plastic bag in combination with~     routine World Health Organization (WHO) thermoregulation care reduces the incidence of~     moderate (32-36° C) or severe (<32.0° C) hypothermia in term infants ≥ 37 0/7 weeks of~     gestational age (GA) when compared to KMC as continuously as possible together with routine~     WHO thermoregulation care.~   "
32493|NCT03141710|"~     Previous work in 2015/16 has identified changes in the gut microbiota with prebiotic~     (Molkosan®) supplement. It report significant changes in metabolic health bio-markers and~     faecal SCFA profile in 18 health adult subjects consuming 20 ml of product twice a day.~     Improvement in fasting metabolic parameters was observed flowing the intervention period. A~     reduction on Total Cholesterol, Glucose, Triglycerides and Insulin was observed.~      In this study, a lower dose (20ml/d) in subjects with type 2 diabetes will be examed, over an~     extended period of time (12 week period) to match the profile of the intended consumer and~     provide preliminary data to support a larger multi-centre trial.~   "
32499|NCT03141632|"~     The aim of this study is to elucidate whether GLP-1 analogues influence not only appetite but~     also thirst perception. It is hypothesized that GLP-1 analogues reduce fluid intake in~     healthy volunteers compared to Placebo.~   "
32500|NCT03141619|"~     This study is designed to test the hypothesis that poor cerebral perfusion during critical~     illness is a risk factor for acute and long-term neurological dysfunction among survivors. We~     use near-infrared spectroscopy to measure brain tissue oxygenation as a non-invasive~     surrogate marker for cerebral perfusion. Acute neurological dysfunction is defined as the~     presence of delirium, which is assessed using the Confusion Assessment Method-Intensive Care~     Unit (CAM-ICU). Chronic neurological dysfunction is defined as having quantitative~     impairments on robotic testing (KINARM robot) and traditional neuropsychological screening~     (Repeatable Battery for the Assessment of Neuropsychological Status).~   "
32501|NCT03141606|"~     Left atrial volume role for CRT response and for arrhythmic events (VT/VF/AT/AF) onset~   "
32502|NCT03141593|"~     Vitamin D deficiency (defined as 25(OH)-vitamin D serum level <50 nmol/l) is cured with~     supplementation by mouth. National guidelines recommend the administration of 800 IU~     cholecalciferol daily for an effective treatment, especially during the winter (poor sun~     exposition). Commercially available pharmaceutical forms are liquid in Switzerland (drops)~     and solid forms in Germany (tablets and capsules). Because therapeutic range of vitamin D3 is~     wide and toxicity is seldom reached, even after the consumption of 200'000 IU, and because~     the administration of 8 drops daily is inconvenient, weekly and monthly administrations of~     the cumulative amount (i.e., 5'600 IU weekly or 24'000 IU monthly) have been investigated.~     Both administration schedules are therapeutic equivalent. The study aims to investigate which~     form (liquid or solid) and which schedule (weekly or monthly) procure the highest adherence~     behavior with outpatients under polypharmacy i.e., with 4 or more medications daily. The~     investigators will use commercially available Swiss and German products.~   "
32503|NCT03141580|"~     The 'Long-term Follow-up Near-infrared Spectroscopy and Intravascular Ultrasound Imaging of~     Internal Carotid Artery Stenosis Treated With Stenting' trial is an academic research~     project. It follows already published results of a research on carotid plaque composition in~     patients undergoing carotid stenting.~      Patients who were treated with carotid stenting will be invited to participate on the trial.~     The written informed consent will be needed. The participants will undergo carotid~     angiography, intravascular near-infrared spectroscopy and intravascular ultrasound of the~     extracranial portion of the internal and common carotid artery with implanted stent.~      The aim of the trial is to describe long-term change of the luminal and stent dimensions,~     vessel wall remodeling and plaque composition after carotid stenting. The findings will help~     to understand the long-term effect of carotid stenting on the carotid stenosis and mechanisms~     of plaque stabilization - sealing with stent.~   "
32504|NCT03141567|"~     Heart failure often causes fluid to accumulate in the body, leading to congestion and~     swelling. However, some people who have had heart failure for a long time seem to have very~     little congestion or swelling, even when the heart failure is poorly treated. The~     investigators think that this is because lymphatic vessels are able to grow and remove fluid~     to prevent congestion. The investigators do not know how lymphatic vessels grow. This study~     will investigate the blood levels of various proteins to try to figure out how the lymph~     vessels of people with long-standing heart failure might grow.~   "
32505|NCT03141554|"~     This study determines the effects of a single dose of different antiseptic mouth washes~     within the oral cavity, on the composition of the oral microbiome using next generation~     sequencing (NGS) techniques. Twelve healthy volunteers will receive all three test products~     in a randomized order to compare the effects of each mouth wash.~   "
32506|NCT03141541|"~     Patients with low back pain and coexisting psychosocial risk factors have a poorer prognosis~     in terms of quality of life, disability, sick leave and health care use. Despite existing~     literature showing that low back pain patients benefit from cognitive therapy interventions,~     this has not been investigated in subgroups of low back pain patients with psychosocial risk~     factors.~      The purpose of the study is to investigate whether patients referred to secondary care with~     low back pain and coexisting psychosocial risk factors will have a better treatment outcome~     when participating in a pain management course in addition to usual care.~      This will be investigated in a randomised study design, where 130 patients with chronic low~     back pain and psychosocial risk factors will be randomly allocated to either usual care or a~     cognitive-therapy based pain management intervention in addition to usual care.~      The patients will be followed for one year after inclusion, and patientreported outcomes on~     disability, pain, sick leave, quality of life and pain coping will be collected by the use of~     questionnaires at baseline, 6 months and 12 months.~   "
32507|NCT03141528|"~     This study investigates whether there is a difference in the BLS skills in first year medical~     students directly after training and three months later, when randomly assigned to~     self-learning versus instructor-led training courses.~   "
32508|NCT03141515|"~     Anesthesia-induced atelectasis is a well-known entity observed in approximately 68-100% of~     pediatric patients undergoing general anesthesia. The collapse of dependent lung zones starts~     with anesthesia induction but can persist for hours or even days after surgery.~      Lung collapse is a pressure-dependent phenomenon. Each acinus has a critical closing~     pressure, i.e., the minimum transpulmonary pressure (Ptp) below that the acinus begins to~     collapse. While airway pressure is homogeneously distributed within all lung units, Pleural~     pressure increases along the vertical gravitational vector because of the lung's weight. As a~     consequence, the decreased Ptp in the dependent zones promotes collapse. This means that~     patients in the supine position suffer from increasing closing pressures in the ventral to~     dorsal direction.~      Alveolar recruitment maneuvers recruit collapsed alveoli, increase gas exchange, and improve~     arterial oxygenation.~      The investigators hypothesized that in children with anesthesia-induced atelectasis, postural~     changes have recruiting effects and improve lung aeration assessed by lung ultrasound.~   "
32509|NCT03141502|"~     A randomized controlled trial is performed to evaluate the effectiveness and safety of the~     Skin Stretching Device (SSD) on limb tension incision closure by comparing whether the~     differences in wounds area, wounds closure time and scar assessment between the SSD and the~     skin grafting are statistically significant.~   "
32555|NCT03140904|"~     This study will be conducted as a stratified cluster randomized trial. The unit of~     randomization will be the outpatient therapeutic feeding center. The 10 health centers will~     be stratified by size, and centers within a stratum will be randomized in a 1:1 ratio to one~     of two schedules of treatment: (1) standard weekly visits or (2) monthly visits with support~     for home-based surveillance.~   "
32510|NCT03141489|"~     Malnutrition is highly prevalent among older adults. Adequate treatment is crucial to~     maintain health, improve functional status and independency. For severely malnourished~     patient, tube feeding is often the most effective treatment, but it also implies a risk of~     developing refeeding syndrome (RFS). RFS is described as fluid and electrolyte shifts~     particular hypophosphatemia when recommencing nutrition, potentially causing fatal~     complications. In 2006 National Institute for Health and Care Excellence (NICE) developed~     guidelines regarding 1) detecting patients at risk for RFS and 2) a treatment plan for~     refeeding severely malnourished patients. These guidelines have never been validated. Hence,~     there is a need to explore the use of different refeeding regimens in the treatment of older~     malnourished patients, in regards to assess safety, as well as the impact of the treatment,~     on functional status, independency, quality of life and RFS. This will be the first~     randomized controlled trial (RCT) that challenges the existing NICE guidelines.This study~     will be divided into two parts. Part I: a cross-sectional cohort study, monitoring occurrence~     of hypophosphatemia on patients detected as not at risk for RFS according to NICE guidelines.~     Part II: a double blinded RCT study, with the aim of tube feeding patients at risk for~     developing RFS, and assigned either to an intervention group or to a control group, comparing~     the different refeeding regimens. This study will help develop safe and validated refeeding~     protocols for severely malnourished older patients.~   "
32511|NCT03141476|"~     This study evaluates the dosage of perioperative cefuroxime for obese patients. Dosage was~     increased if the BMI was over 30kg/m*m and as well over 50kg/m*m. Drug levels were measured~     in blood and tissue.~   "
32512|NCT03141463|"~     Immune modulating effects and safety of Vvax001; different dosages will be tested in patients~     with a history of (pre) malignant cervical lesions.~   "
32513|NCT03141450|"~     Surgical site infection (SSI) is a serious operative complication that may be associated with~     any surgical procedures. It increases morbidity and mortality after cardiac surgery. Plasma~     concentration of prophylactic antibiotic, routinely cefazolin, is altered by effects of~     cardiopulmonary bypass. This study is conducted to measure the plasma concentrations of~     cefazolin to determine its adequacy in pediatric patients undergoing elective cardiac surgery~     with cardiopulmonary bypass including its correlation with the incidence of postoperative~     SSI.~   "
32514|NCT03141437|"~     The goal of this research study is to learn if a decision aid website that provides~     information about fertility preservation (maintaining participant's ability to have children~     of participant's own after cancer treatment) can help women with cancer make~     fertility-preservation decisions. Researchers will also use information learned in this study~     to help improve the website. This website was developed at MD Anderson.~      There are several ways to preserve fertility, including taking drugs to stop or control ovary~     function in order to freeze eggs and/or embryos. Freezing eggs and/or embryos may increase~     the chances of having a child of participant's own in the future. Participant may also choose~     to have children using other methods, such as adoption. This website is designed to help~     women learn more about these options and consider which of them may be best for them.~   "
32515|NCT03141424|"~     Background: Asthma is a common chronic condition characterized by respiratory symptoms and~     hyperresponsive airways. According to treatment guidelines, patients with persistent asthma~     require daily treatment with inhaled corticosteroids (ICS). However, certain subgroups of~     asthma patients such as non-eosinophilic asthma patients do not respond well to the ICS~     treatment. In the present study, asthma patients treated with ICS and exhibiting low levels~     of eosinophilic biomarkers such as S-periostin, FeNO and blood eosinophils, are randomized~     1:1 to either 1) tapering of ICS or 2) usual care. Thus, the aim of the present study is to~     investigate whether patients with non-eosinophilic asthma can sustain their level of disease~     control during ICS tapering.~      Design: This is a randomized, controlled, one-center, non-inferiority study of ICS tapering~     in patients with non-eosinophilic asthma.~      Inclusion and exclusion criteria: 1) Objectively secured asthma diagnosis, 2) Age 18-65~     years, 3) ICS treatment equivalent to Budesonide 800 microgr daily or more with at least 80%~     adherence, 4) Serum-periostin < 50 ng/ml, 5) FeNO<20 ppb at all prior visits, 6)~     Blood-eosinophils<0.15 at screening, 7) no allergic asthma history, 8) never daily smoker, 9)~     no other respiratory diasease, 10) no daily treatment with immunosuppressives, 11) no~     pregnancy, and 12) no history of drug or alcohol abuse.~      Endpoints: Primary: Change in Control Questionnaire (ACQ) from baseline to post-tapered ICS~     and time from baseline to drop-out. Secondary: Change in FeNO, change in Serum-Periostin,~     change in FEV1, change in blood-eosinophils.~      Methods: Relevant patients will be recruited from Respiratory Outpatient Wards. In total, 110~     patients will be required. Visits will be performed at screening, at week 0, 4, 8, 12, 16,~     26, 52. In the active arm, ICS dosage will be reduced to 50% at week 0 and removed at week 8.~     All visits include ACQ, FeNO, spirometry, blood eosinophils. S-periostin will be measured at~     screening and at week 8 and 16.~   "
32516|NCT03141411|"~     Goal-directed fluid therapy (GDFT) strategies based on cardiac output (CO) optimization have~     been shown to benefit moderate- to high-risk surgery patients and have recently been~     recommended by professional societies in the UK, in France, and in Europe. However, despite~     the growing evidence, these strategies are often not implemented in current practice. One of~     the reasons for this lack of implementation is that GDFT strategies, like any other complex~     clinical protocol, require significant provider attention and vigilance for consistent~     implementation and it is well known that even under study conditions protocol compliance~     rates are often not greater than 50%. To overpass this problem, our CO monitoring devices~     (EV1000, Edwards Lifesciences) have now an incorporated assisted fluid management software.~     This software determines fluid responsiveness by estimating the predicted change in stroke~     volume and suggests to the anesthesiologist when fluid is required .~   "
32517|NCT03141398|"~     A prospective, observational, comparative study with no intervention.The objective of the~     study to compare the efficiency of detecting glycemic abnormalities using Continuous Glucose~     Monitoring (CGMs) versus Oral Glucose Tolerance Test (OGTT) and HbA1C (Glycated Hemoglobin)~     and their relation to iron overload detected by T2* MRI of the pancreas in high-risk patients~     due to insulin deficiency (potential beta cell injury) and those with insulin resistance and~     to study the different factors that may affect the glycemic control in these patients in~     relation to their results like the Dose of corticosteroids and chemotherapy in ALL and~     Hemoglobinopathies, Liver function in ALL and Hemoglobinopathies, and Serum ferritin in~     Hemoglobinopathies and their transfusion status. Using Validated Tools with Permission, the~     participants will be selected through probability (random) sampling method with expected~     subjects numbers ALL/L: 30-50, Thalassemia Major: 20, Sickle cell disease: 20.~   "
32518|NCT03141385|"~     The purpose of this study is to test the hypothesis that remote ischemic preconditioning~     prevents acute kidney injury and improves clinical outcomes in patients undergoing total arch~     replacement.~   "
46540|NCT02957708|"~     This study examines the effect of combining modified constraint-induced movement therapy~     (mCIMT) and self-regulation (SR) in promoting upper limb function of children with hemiplegic~     cerebral palsy (CP) studying in a school-based setting.~   "
32519|NCT03141372|"~     Acute urinary retention is a complication of hysterectomies that can result in bladder~     over-distension and long term bladder dysfunction. The incidence of acute urinary retention~     after total laparoscopic hysterectomy (TLH) has been reported to be anywhere between 4% and~     34%. Studies have varied in the method of post-operative bladder challenge and the modality~     of hysterectomy included. Moreover, most of the published studies are retrospective chart~     reviews or prospective observational studies, with a lack of randomized controlled trials.~     Risk factors for urinary retention include type of anesthesia used, how the hysterectomy is~     performed, use of post-operative narcotics, pre-operative urinary retention, and possibly~     aggressive bladder dissection. With the increased trend towards same-day discharge following~     TLH, urinary retention may cause unnecessary patient distress and a worsened post-operative~     course. Standardization of post-hysterectomy bladder challenge and identification of risk~     factors for urinary retention may aid in preventing urinary retention or acute bladder~     dysfunction. The primary objective is to compare the rate of void trial failure after TLH~     with the backfill technique versus the autofill technique.~   "
32520|NCT03141359|"~     This is a single-arm, single-stage Phase II study designed to evaluate the 1-year PFS rate in~     subjects with locally-advanced NSCLC (stage II/III) and treated with Stereotactic Body~     Radiation Therapy (SBRT) followed by concurrent mediastinal chemoradiation with or without~     consolidation chemotherapy. A total of 56 subjects will be enrolled to this study over a 3~     year accrual period.~   "
32521|NCT03141346|"~     This study will determine whether a home visitation program incorporating sugar sweetened~     beverage and juice (SSB/J) reduction and home water delivery affects maternal and infant risk~     for obesity. The postpartum period is a time of both opportunity and vulnerability for~     mothers and their infants to diminish risk for obesity and related health problems. This is~     particularly relevant in the context of Hispanic families. Hispanic mothers are at high-risk~     for excess gestational weight gain and postpartum weight retention, and their infants are at~     high-risk for rapid weight gain associated with early onset obesity. A contributing factor~     may be their intake of SSB/J. There is a high prevalence of reported SSB/J consumption in~     low-income Hispanic households, and Hispanic mothers are more likely to incorporate sweet~     foods during weaning. Because evidence suggests that obese Hispanic children are responsive~     to SSB/J reduction and substitution with non-caloric beverages, this may be a potential~     strategy for Hispanic mothers that may also be beneficial for their infants.~      This study will be conducted in collaboration with Antelope Valley Partners for Health, who~     will deliver a home visitation program intervention once a week for 24 months.~     Two-hundred-and-forty overweight/obese Hispanic mothers and their infants will be recruited.~     They will be randomly assigned to: group 1, a standard home visitation program only; group 2,~     a standard home visitation program that incorporates sugar reduction; and group 3, a standard~     home visitation program that incorporates sugar reduction with home water delivery. The main~     outcomes are maternal BMI and infant weight-for-length growth. We will also assess maternal~     and infant diet using 24-hour recalls, and maternal feeding style and infant eating behaviors~     using questionnaires. Linear mixed effects models will be used to compare changes between the~     intervention groups in maternal BMI and infant weight-for-length.~   "
32522|NCT03141333|"~     The principal study goals are to determine if a randomized control trial would be feasible,~     particularly with regards to i) recruitment and retention of parents of children having a~     diagnosis or a suspicion of diagnosis of DCD, and ii) parents' utilization of the~     teleintervention. The study will also examine quantitatively and qualitatively families'~     acceptability of- and satisfaction with the teleintervention.~   "
32523|NCT03141320|"~     This is a grounded theory study aiming to understand women's perception of what influences~     their confidence for birth during labour and birth. Data is being collected using interviews~     and social media sources.~   "
32524|NCT03141307|"~     Obtaining adequate informed consent from potential research participants is a significant~     challenge for biobank-dependent research. To maintain public trust and support, it is~     important to establish an informed decision-making process for the collection and use of~     biospecimens collected within clinical settings. For the majority of all infants born in the~     US, residual dried blood biospecimens are generated after newborn screening is completed.~     Some programs choose to store these specimens for several uses including biomedical research.~     Identifying ways to improve comprehension about broad consent for future biobank-dependent~     research is a national priority. Specific Aim 1: Identify the key information items necessary~     to make an informed decision about broad consent for the retention and future research use of~     residual biospecimens. Methods include focus groups with new parents to determine key~     information elements relevant to consent for use of residual biospecimens within the Michigan~     BioTrust. Additional meetings with IRB personnel within the participating hospitals, health~     departments and universities will also be conducted to ascertain their expectations and~     requirements for the consent process. Specific Aim 2: Based on the data collected in Aim 1,~     create a state-of-the-art electronic informed consent information (EICI) tool for use in the~     clinical setting about the retention and use of residual biospecimens. The award-winning~     Genetic Science Learning Center will develop the professional EICI in Spanish and English.~     Validation of the EICI will be completed using feedback from both community and scientific~     advisory boards for the Michigan BioTrust. Specific Aim 3: Evaluate the EICI consent approach~     by comparing it to: a) traditional consent delivered on an electronic tablet; and b) the~     current paper-based consent approach. Both Spanish and English speaking parents (n = 630) in~     the state of Michigan, where informed consent is required for biobank research during~     postpartum clinical care, will be recruited and randomized to one of three groups. Specific~     Aim 4: Assess feasibility of the EICI through focus groups and interviews with birthing~     hospitals and Department of Community Health staff before and after the intervention.~        -  Hypothesis 1) Women in the Interactive technology group (Group A) and the video group~          (Group B) will demonstrate higher knowledge at Time 1 and Time 2 about the consent~          elements and the BioTrust than those who do not receive either EICI tool (Group C).~        -  Hypothesis 2) Women in the EICI groups (Groups A and B) will demonstrate lower~          decisional conflict at Time 1 and Time 2 toward biobanking than those who do not receive~          the EICI (Group C).~        -  Hypothesis 3) Women in the EICI groups (Groups A and B) will not differ significantly in~          their choices about biobanking and attitudes toward NBS and biobank research compared to~          participants who do not receive EICI tool (Group C).~   "
32525|NCT03141294|"~     Percutaneous dilatational tracheostomy (PDT), especially single-step dilatational~     tracheostomy (sd-PDT), is now frequently preferred to surgical tracheostomy. Occasionally, it~     needs a second dilation maneuver .Dissection of the deep cervical fascia during PDT, known as~     reformative PDT (re-PDT), may facilitate the procedure. This study was designed to compare~     re-PDT with sd-PDT in ICU patients~   "
32526|NCT03141281|"~     The study will compare the effect of broad and directed (narrow) technology-based training on~     basic perceptual and cognitive abilities in older adults and on the performance of simulated~     tasks of daily living including driving and fraud avoidance.~   "
32527|NCT03141268|"~     Orocecal transit time is studied in individuals with irritable bowel syndrome (IBS) of both~     the constipation-dominant, diarrhea-dominant, and mixed form using the lactulose hydrogen~     breath test for orocecal transit time through the gut. Data are compared to those of healthy~     volunteers. The peak value of fermentation as read by hydrogen levels is captured after~     passage of the orocecal segment in the colon. Comparison are made between IBS patients and~     healthy subjects as regards orocecal transit time and peak fermentation in the cecum.~   "
32528|NCT03141255|"~     The purpose of the study is to compare patients with cardiogenic shock who receive standard~     therapy plus therapeutic hypothermia (TH) to patients with cardiogenic shock who receive~     standard medical therapy alone in order to assess the safety of TH in patients with~     cardiogenic shock. This study will also help understand the physiologic effects of TH in~     patients with cardiogenic shock. This will be a pilot study to establish the initial safety~     of TH and to assess tolerability of TH in this patient population.~   "
46541|NCT02957695|"~     In this randomized double-blind controlled study we would like to test the benefit of~     neurofeedback for the recovery of patients with frontal brain injury during an early stage of~     neurorehabilitation.~   "
32529|NCT03141242|"~     The main goal of the ENACT (ENgaging in Advance Care planning Talks) Group Visit intervention~     is to integrate a patient-centered advance care planning process into primary care,~     ultimately helping patients to receive medical care that is aligned with their values. The~     ENACT Group Visit intervention involves two group discussions about advance care planning~     with 8-10 patients who meet for 2-hour sessions, one month apart, facilitated by a~     geriatrician and a social worker. This study will compare the ENACT Group Visit intervention~     to mailed advance care planning materials.~   "
32530|NCT03141229|"~     Mindfulness training for teacher and children of primary schools. Blinded and controlled~     study design. Burnout as primary outcome for teacher and classroom behavior for children.~   "
32531|NCT03141216|"~     This study evaluates the effects of VCV, PCV and PSV ventilatory modes during the immediate~     postoperative period on the variables resulting from regional and global pulmonary electrical~     impedance and diaphragmatic mobility, as well as perform ventilator synchrony analysis in PSV~     mode by mechanical ventilator. Half of the participants will receive VCV followed by PSV for~     weaning, while the other half will receive PCV followed by PSV for weaning.~   "
32532|NCT03141203|"~     This is a multicentre phase I/II trial looking at the combination of romidepsin and~     carfilzomib. The aim of the phase I part is to determine the maximum tolerated dose of the~     combination. This part will recruit up to 27 patients.~      The aim of the phase II part is to assess the activity of the combination at the maximum~     tolerated dose in 28 patients.~      Patients will receive 8 cycles of romidepsin with carfilzomib and response will be assessed~     every second cycle. Patients will be followed up for progression and survival until the end~     of the trial.~   "
32533|NCT03141190|"~     Our understanding of the magnitude of physician burnout, its relationship to diminished~     performance and the development of mental and physical illness is crystalizing. Data now~     links burnout with diminished physician professionalism, patient outcomes, hospital economics~     and patient safety.~      Moreover, burnout appears to be a surrogate measure of distress among physicians. In a~     national survey of practicing surgeons, alcohol misuse and suicidal ideation were up to 3~     times that of the general population. When burnout was present the likelihood increased 25%~     and 90%, respectively. Among physicians in general, burnout increases the likelihood of~     depressive symptoms 170%. In surgical trainees, there is alarming prevalence of distress~     symptoms, with a recent national survey (manuscript in preparation) showing 16% suicidal~     ideation, 32% moderate to severe depression, 58% high stress and 61% alcohol misuse or abuse~     among PGY-3s. It has been proposed that chronic and overwhelming stress in the absence of~     adequate coping skills promotes burnout and associated distress symptoms. It has also been~     posited that performance deficits, from surgical errors to poor professionalism, derive in~     large part from the deleterious effects of stress on cognition.~      Mindfulness mental training, most frequently in the form of Mindfulness-Based Stress~     Reduction (MBSR, as developed by John Kabat-Zinn), has been shown to protect or enhance~     cognition, well-being and physical health in multiple clinical populations and in healthy~     adults. Two decades of research have shown that MBSR and MBSR-based interventions create new~     habits in the brain subserved by organic, structural changes. Such interventions have been~     shown to protect cognitive function in pre-deployment marines and incarcerated juveniles;~     reduce relapse in major depressive disorder; enhance immune function in HIV+ males; reduce~     PTSD severity in veterans; enhance job performance in inner-city teachers; improve cognitive~     function and pro-social skills in children; increase professionalism and decrease burnout in~     PCPs; improve work satisfaction and engagement in numerous populations of health care~     workers; and diminish psychological stress in soldiers, physicians and professional athletes.~      This study seeks to demonstrate the feasibility of mindfulness training in surgical Interns~     while simultaneously providing objective pilot data on the effectiveness of mindfulness~     training in a randomized, controlled setting. In-coming surgical Interns will be recruited,~     randomized to mindfulness training or an active control group and undergo psychologic,~     physiologic, neurocognitive, neuroanatomic and performance assessments at baseline,~     post-intervention and one year later. Data will inform sample size calculations for~     subsequent, adequately-powered RCTs and will guide the creation of a feasible formal training~     model. Moreover, results could significantly impact formal medical training, the mental~     health of providers at every level, and the overall quality of patient care.~   "
32534|NCT03141177|"~     The purpose of this study is to determine whether Nivolumab Combined with Cabozantinib is~     safe and effective compared to Sunitinib in previously untreated advanced or metastatic renal~     cell carcinoma~   "
32535|NCT03141164|"~     This study will train participants (young people and older adults) to do a visual task, and~     will assess whether this results in changes in behavioral assessments. In some participants,~     we will be also testing whether MRI measures (cortical thickness, functional connectivity)~     change with training.~   "
32536|NCT03141151|"~     This study is a family-centered, community-based intervention to prevent and treat childhood~     obesity among 3-5 year old children from undeserved communities. Half of participants will~     receive a healthy lifestyle intervention and half of participants will receive a~     school-readiness intervention.~   "
32537|NCT03141138|"~     This study is a Phase 1, randomized, open-label study of the prime-boost vaccine candidates~     given in the prime-boost regimen previously demonstrated to have a high level of~     immunogenicity and immune durability: Day 0 prime (PIV) and Day 180 boost (LAV), and compare~     it with a previously untested schedule: Day 0 prime (PIV) and Day 90 boost (LAV) in order to~     define the potential tradeoff between potential immunogenicity, including cell-mediated~     immunity, and a more practical dosing schedule.~   "
32538|NCT03141125|"~     Study about the effect of ethanol extract physalis angulate in scleroderma patients with~     standard therapy to reduce skin fibrosis based on modified Rodnan Skin Score, reduce~     inflammation, immunological response and fibrosis: A Randomized Clinical Placebo~     ControlledTrial with a prospective cohort study on scleroderma outpatient clinic in Cipto~     Mangunkusumo Hospital in Jakarta and Hasan Sadikin Hospital in Bandung, from January 2016 to~     July 2017~   "
32539|NCT03141112|"~     The study will evaluate the benefit of early initiation of CRRT in the initial phase of~     severe sepsis in patients admitted to the ICU. Primary evaluated end-point is 28-day~     mortality. Secondarily evaluated end-point is length of ICU-stay, length of stay in hospital,~     duration of mechanical ventilation. There are two groups. One group of participants with~     early CRRT initiation and another group with late CRRT initiation. Reference group no CRRT.~   "
32540|NCT03141099|"~     This study compares two blood pressure targets and two oxygenation targets in the~     post-resuscitation care of comatose out-of-hospital cardiac arrets patients. Using a novel~     method the blood pressure-intervention is double-blinded. The oxygenation-intervention is~     open-label. As a subordinate study, the patients will be randomized 1:1 to active~     fever-control with an automated feedback temperature control-device for 36 or 72 hours~     following return of spontaneous circulation.~   "
32541|NCT03141086|"~     The main purpose of this study is to demonstrate that LML134 can increase wakefulness~     compared to placebo in patients with shift work disorder (SWD) measured by objective and~     subjective endpoints of wakefulness, i.e. the sleep latency in the multiple sleep latency~     test (MSLT) and the Karolinska Sleepiness Scale (KSS), respectively. Safety and PK of LML134~     will also be evaluated. In addition, novel methodologies to measure wakefulness and sleep~     will also be tested and compared to gold standard methods like the MSLT and polysomnography~     (PSG). The aim of such comparisons is to evaluate the usefulness of the new technologies in~     clinical studies and provide preliminary validation data.~      This is a randomized, subject and investigator-blinded, placebo controlled, crossover,~     multi-center Proof of Concept (PoC) study with in-house simulated laboratory night shifts in~     patients with SWD. This non-confirmatory study will include two treatment arms: LML134 and~     placebo. After a screening period, the treatment phase of the study will consist of two~     overnight stays in a sleep lab in each of two treatment periods, with a minimum one week~     wash-out in between.~   "
32542|NCT03141073|"~     This study evaluates the efficacy and safety and population PK of HMS5552 as add on to~     Metformin in type 2 diabetic adult subjects, there will be 2 groups, in the first 24 weeks,~     one group will receive HMS5552 plus Metformin, while the other group will receive placebo~     plus Metformin; after 24 weeks, all subjects received HMS5552 plus Metformin for 28 weeks.~   "
32543|NCT03141060|"~     This study will evaluate the pharmacokinetics, safety, and tolerability of the~     anti-tuberculosis (TB) drug delamanid (DLM) in combination with an optimized multidrug~     background regimen (OBR) for multidrug-resistant tuberculosis (MDR-TB) in HIV-infected and~     HIV-uninfected children with MDR-TB.~   "
32544|NCT03141047|"~     A new psychological trauma treatment method is tested on a population (n 100) of adult women~     who have been sexually traumatized at one specific time 0-5 years before they enter the~     study.~   "
46542|NCT02957682|"~     The main purpose of this study is to evaluate the effect on mental state (known as~     neurocognitive function) with use of Praluent.~   "
32545|NCT03141034|"~     The investigators hypothesize that this combination regimen of irinotecan plus ramucirumab~     administered as second line treatment will be tolerated and lead to improved outcomes similar~     to paclitaxel plus ramucirumab in patients with advanced gastric and gastro-esophageal~     junction (GEJ) cancers. This study proposes a phase II clinical trial with irinotecan plus~     ramucirumab for treatment of patients with metastatic gastric and GEJ adenocarcinoma who have~     progressed after first line chemotherapy. To the knowledge of the investigators, this regimen~     has not been previously administered to this patient population, so safety and tolerability~     will be monitored and reported.~   "
32546|NCT03141021|"~     First, the investigators plan to use a retrospective analysis to determine the clinical~     landscape of neurofibromatosis (NF)1-associated malignant peripheral nerve sheath tumor~     (MPNST) and precursor lesions (e.g., atypical or nodular plexiform neurofibromas). A~     worldwide database will be established, collecting, in a standardized manner, histologic,~     immunohistochemical, molecular, radiographic, treatment, and related clinical data from~     centers worldwide with expertise in these NF1-related cancers. Although retrospective in~     nature, the resulting data from this registry may reveal previously unanticipated patterns,~     similar to the INFACT effort outcome. This registry would then allow the acquisition of data~     associated with MPNST biospecimens collected under associated banks (frozen or~     paraffin-embedded, germline (or normal tissue DNA) samples, and any previously somatic~     whole-exome or whole-genome sequencing data for aggregate analyses). Second, the~     investigators plan to co-register patients to institutional banks in order to prospectively~     collect MPNST samples for analysis. These patients will be consented in order to collect the~     above information and for banking of tumor tissue and future studies that include genomic~     characterization of the tumors.~   "
32547|NCT03141008|"~     To evaluate the impact of a Low Carbohydrate Ketogenic Diet (LCKD) weight loss program and~     compare to the standard of care program established for patients with Non-Alcoholic Fatty~     Liver Disease (NAFLD) on: (1) Liver fat and liver stiffness scores, (2) lipid profile and~     insulin sensitivity; and (3) depression scores and quality of life, and (4) Cardiometabolic~     measures such as cardiopulmonary exercise test (CPET) and transthoracic echocardiogram (TTE).~   "
32548|NCT03140995|"~     Regular physical activity is important for people with rheumatoid arthritis (RA). Sleep~     requirements for adults should be on a 'sleep needs spectrum' of between 7 to 9 hours per~     day. Poor sleep is a common complaint among people with RA, which may have an effect on their~     activity levels and well-being. There is evidence that physical activity and exercise can~     improve sleep quality and disturbances in other chronic disease populations therefore,~     examining how same affects sleep in RA is important.~   "
32549|NCT03140982|"~     Using very slow or fast propofol intravenous injection, monitored using standard American~     Society of Anesthesiology (ASA) standard and SEDLine EEG (Med Tech), the patient was evaluate~     by a neurologist every 30 sec using the FOUR coma scale.~   "
32550|NCT03140969|"~     The purpose of this study is to evaluate the safety and tolerability of QR-110 administered~     via intravitreal injection in subjects with LCA due to the CEP290 p.Cys998X mutation.~   "
32551|NCT03140956|"~     The purpose of the study is to investigate PK of levodopa in plasma after repeated doses of 3~     levodopa formulations given in combination with carbidopa and ODM-104 and compared to the PK~     of standard IR and CR levodopa formulations in the same combination.~   "
32552|NCT03140943|"~     All patients with multiple myeloma (MM) are destined to relapse even with the best available~     approved agents. Median OS from diagnosis in the current era is reported at 5.4 years. Given~     that myeloma remains an incurable disease, future improved OS is therefore reliant on the~     expansion of salvage options for patients with RRMM.~      Carfilzomib (formerly PR-171) is a tetrapeptide epoxyketone-based irreversible inhibitor of~     the 20S proteasome. This second-generation proteasome inhibitor (PI) is structurally and~     mechanistically different to the dipeptide boronic acid PI, bortezomib. Compared to~     bortezomib, carfilzomib showed less off-target activity that may account for the reduced~     myelosuppression and reduced neuropathy that is observed compared to bortezomib. As~     monotherapy, carfilzomib has demonstrated robust and durable activity in heavily pre-treated~     patients with RRMM in phase I and II trials The idea of combining a PI and an~     immunomodulatory drug (IMiD) such as thalidomide or lenalidomide is attractive in MM due to~     the efficacy previously demonstrated with combination bortezomib, thalidomide and~     dexamethasone. Such efficacy obviates the need for chemotherapy that is known to induce~     genetic instability and in turn gives rise to secondary cancers. In combination with~     lenalidomide (25mg), Niesvizky and colleagues have demonstrated a maximum planned dose (MPD)~     of carfilzomib as 20/27 mg/m2 with promising safety and efficacy. Combination carfilzomib and~     thalidomide, as opposed to lenalidomide, is practically a more affordable regimen that will~     be more applicable to the Asia-Pacific region.~   "
32553|NCT03140930|"~     Rationale: The appearance of tastants in the small intestine can result in the activation of~     a negative feedback mechanism from different parts of the intestine to the stomach, the small~     intestine and to the central nervous system. These processes inhibit food processing,~     appetite sensations and food intake, and furthermore they increase feelings of satiety and~     satiation. The effects of intraduodenal and/or intraileal infusion of a combination of~     tastants (sweet (rebaudioside A), bitter (quinine) en umami (monosodium glutamate(MSG))) and~     placebo on ad libitum food intake, satiation and gastrointestinal symptoms will be~     investigated.~      Objective: To investigate the effect of intraduodenal, intraileal and combined infusion of a~     combination of tastants versus infusion of placebo on food intake.~      Secondary objectives:~        1. To compare the effect of intraduodenal versus intraileal versus combined intraduodenal~          and intraileal delivery of a combination of tastants on satiation.~        2. To assess the effect of intraduodenal and/or intraileal delivery of a combination of~          tastants on gastrointestinal symptoms/complaints.~   "
32554|NCT03140917|"~     In liver surgery peroperative assessment och the future liver remnant (FLR) is pivotal in~     order to avoid posthepatectomy liver failure. To date this is mainly performed by measuring~     the volume of the FLR. Of course FLR volume acts as a surrogate measure of FLR function and~     the correlation between volume and function is not always accurate. Several techniques to~     assess FLR function has been proposed. Hepatobiliary scintigraphy (HBS) and Dynamic MRI are~     the two such methods. In this study we compare HBS and MRI, in addition to contrast-enhanced~     CT and ICG, repeatedly performed before and after right hepatectomy in patients with~     colorectal liver metastases treated with neoadjuvant chemotherapy.~   "
32556|NCT03140891|"~     In very preterm infants with severe respiratory distress syndrome(RDS), invasive~     ventilation(IV) , besides nasal continuous positive airway pressure (NCPAP) and~     early/selective pulmonary surfactant administration, is one key cornerstone to reduce~     neonatal mortality. However, IV is related to increased risks of bronchopulmonary dysplasia~     (BPD) and abnormal developmental outcomes in the survival.Weaning from IV is therefore a key~     procedure to reducing these risks above, and if extubation does not success, repeated~     intubation and/or prolonged duration of IV will result in increased medical burden and~     intubation-associated complications and death. How to minimize the need for endotracheal~     ventilation and subsequent complications constitutes a challenge for neonatologists.~   "
32557|NCT03140878|"~     The study is a mono-center, randomized, semi-blinded, placebo-controlled, cross-over,~     proof-of principle study in healthy volunteers. The study will determine the probiotic effect~     of LGG on intestinal tissue and intestinal cells~   "
32558|NCT03140865|"~     Efforts to find treatments for AD have yielded only modest benefits, likely because~     longstanding AD pathological processes induce irreversible neurological compromise. These~     processes begin years before the onset of clinical symptoms. This possibility has been~     incorporated into a model describing stages of AD development, articulated by the~     NIA/Alzheimer's Association preclinical workgroup of which the Co-Director of the Kulynych~     Alzheimer's Research Center, Dr. Suzanne Craft, was a member. According to this model, the~     best hope for countermanding the effects of AD lies in intervening at the earliest possible~     point in the pathological cascade. There are several important ongoing efforts in adults with~     preclinical AD that directly target amyloid aggregation. Although this strategy addresses an~     important aspect of the AD pathological cascade, we believe that addressing metabolic~     dysfunction affecting glucose and insulin regulation offers a complementary approach, in that~     it may reduce amyloid burden and toxicity, while also directly enhancing synaptic health,~     brain metabolism, tau regulation and neurovascular function.~      The purpose of the ADCC is to identify and characterize early risk factors that predict~     cognitive decline and dementia in asymptomatic adults and adults with early signs of~     cognitive impairment. The data obtained from this study, collected at enrollment and~     follow-up will allow us to examine disease trajectory in individuals with and without~     prediabetes and other measures of glucoregulatory dysfunction in this process. The enrollees,~     who will be well-characterized with regard to cognitive and metabolic status through ADCC~     assessments, will provide an important resource for other local (institution) and national~     investigations. Data collected from participants enrolled in the ADCC will be stored~     indefinitely for future investigations.~   "
32559|NCT03140852|"~     The goal of this study is to obtain data about the effectiveness, reach, adoption, and~     implementation potential of an innovative, combined urinary/bowel continence workshop through~     a randomized controlled trial in six Wisconsin communities. This three-session workshop is~     based on proven principles of behavior change addressing urinary and bowel continence~     self-management and health education and has been developed specifically for administration~     to women age 50 and older in senior centers. We hypothesize that workshop participants will~     experience improvements in urinary and bowel incontinence symptoms, will have increased~     levels of care-seeking and self-efficacy for these conditions, and will maintain the~     self-management strategies taught in the workshop 3 months following completion of the~     workshop. We further hypothesize that this workshop will reach its intended target population~     (independent senior women with incontinence) and will improve their mental health by~     destigmatizing the condition of incontinence.~   "
32560|NCT03140839|"~     The proposed research will study the effects of Imaginal Rescripting (IR) for social anxiety~     disorder (SAD). IR guides patients to change their memories of past socially painful events.~     Initial studies have found that a single session of IR significantly reduces SAD symptoms,~     however it is not yet clear how or why IR works and whether its effects are long lasting. To~     answer these questions, the investigators will randomly assign adults with SAD to receive~     either IR, or two other types of brief psychological interventions: Imaginal Exposure and~     Supportive Counselling. Changes in participants' memories, social anxiety symptoms, quality~     of life, negative beliefs, and social behaviour over the course of a 6-month period will be~     assessed. This study will provide valuable insight into the short- and long-term effects of~     IR and clarify the mechanisms through which IR works. Ultimately, this knowledge will enable~     the development of more effective treatments and prevention programs for SAD.~   "
32561|NCT03140826|"~     Stool samples will be collected from two groups of neutropenic patients in the case that a~     therapy with either meropenem or piperacillin/tazobactam is needed due to a suspected~     infection. The intestinal resistome will be determined and quantified using shotgun~     metagenomics. Based on this, regression models will be used to determine the actual selection~     pressure caused by these drugs, and both selective forces will be compared. The results will~     reveal if there is a drug that causes a lower selection pressure compared to the other. The~     study aims to generate knowledge that is required to design effective antibiotic stewardship~     programs.~   "
32562|NCT03140813|"~     This study will investigate the safety, tolerability and blood pharmacodynamics of treatment~     with oral administration of AZD7325 at 5 mg BID, 15 mg BID, and placebo BID, in adults with~     Fragile X Syndrome. The study also will also investigate measures of efficacy and biomarkers~     during treatment.~   "
32563|NCT03140800|"~     Intrauterine contraceptive device is one of the most efficient and reversible methods of~     birth control with low cost and long duration of use However, in the first year after~     insertion, between 5 and 15% of women will have their Intrauterine contraceptive device~     removed because of irregular uterine bleeding which have been attributed to the effect of~     contact between the device and the endometrium and even the pressure on the uterine muscle .~     The disharmonious relationship between the Intrauterine contraceptive device and the uterus~     is the cause of most of the bleeding complaints, so bleeding is related to improper position~     rather than the contraceptive method itself which should be excluded before abandoning the~     Intrauterine contraceptive device for any other method of birth control~   "
32584|NCT03140527|"~     This trial will consist of two parts: Part 1 and Part 2. Part 1 will enroll adult healthy~     volunteers (HV) into four treatment groups. The first group will enroll HV into a single~     ascending dose (SAD) treatment group consisting of three cohorts. The second group will~     enroll HV into a multiple ascending dose (MAD) treatment group consisting of three cohorts.~     The third group will enroll HV into a food effect (FE) treatment group consisting of one~     cohort. The fourth group will enroll HV into a drug-drug interactions (DDI) treatment group~     consisting of one cohort. Part 2 Cohorts 1 through 3 will enroll adult subjects with cystic~     fibrosis (CF) currently on stable ivacaftor/lumacaftor background therapy for a minimum of~     three months into a MAD treatment group consisting of three cohorts. Part 2 Cohort 4 will~     enroll adult subjects with CF not currently receiving or have received cystic fibrosis~     conductance regulator (CFTR) modulator therapy within 30 days prior to Day 1. Approximately~     125 subjects will be enrolled.~   "
32564|NCT03140787|"~     68 healthy children from the Department of Pediatric Dentistry at Damascus University who~     require treatment for their primary maxillary second molars will be randomly assigned into~     one of two groups: experimental or control groups. In the experimental group, a lidocaine~     hydrochloride-epinephrine hydrochloride nasal spray will be applied to anesthetize upper~     second molar before the commencement of treatment.~      To assess the efficacy of this kind of anesthesia, a specific scale will be used by an~     external observer after capturing some video files of the performed treatment.~      To assess the safety of this procedure, vital signs will be recorded before and after~     treatment.~      Acceptance of the nasal spray will be recorded based on the child's behavior before and after~     treatment using Frankl scale.~      If anesthesia was not sufficient to proceed with the procedure, a rescue anesthesia would be~     used. Rescue anesthesia consists of an infiltration injection of lidocain hydrochloride 2%~     with epinephrine hydrochloride (1:100,000). In the control group, an intra-oral~     lidocaine-epinephrine injection will be applied due to treatment. Safety, efficacy and~     acceptance will be assessed in the same manner to what is performed in the experimental~     group.~   "
32565|NCT03140774|"~     The Oxford University is undertaking a follow-on study to a Phase 1 study involving the two~     viral vectored Ebola vaccines Ad26-ZEBOV and MVA-BN-Filo. The aim of this study is to~     investigate the persistence of the vaccine induced immune response at 24-30 and 36-42 months~     following primary vaccination.~   "
32566|NCT03140761|"~     To investigate the correlation between four well-known polymorphisms of the glucocorticoid~     receptor gene (two with reduced sensitivity versus two with increased sensitivity) and the~     prevalence of secondary adrenal insufficiency in glucocorticoid-treated patients with~     exacerbation of COPD.~   "
32567|NCT03140748|"~     Intraabdominal fungal infections with Candida are constantly increasing. Their diagnosis and~     treatment is difficult. Morbidity and mortality are high. Β-D-Glucan has been proposed as a~     marker of systemic fungal infection in candidemia. Moreover, its kinetics is associated with~     therapeutic success. On the other hand, there are no data on intraabdominal infections that~     are much more frequent. The objective of the study is to evaluate the initial levels of~     β-D-glucan and its daily kinetics during the treatment of fungal peritonitis in resuscitation~     compared to a control group with a yeast-free peritonitis.~   "
32568|NCT03140735|"~     Aortic valve pathology is the third most common cardiovascular disease after coronary artery~     disease and hypertension, which is responsible for severe morbidity and mortality in elderly~     patients and requires surgical treatment in its most severe form of progression. The purpose~     of this study is to find a link between arterial stiffness and degenerative aortic stenosis.~     If this link is established, arterial stiffness may become a medical therapeutic target in~     order to delay the evolution of the disease.~   "
32569|NCT03140722|"~     This is a Phase 2, randomized, open-label study to evaluate vadadustat versus epoetin alfa~     for the treatment of anemia in subjects with DD-CKD who are hyporesponsive to ESAs.~   "
32570|NCT03140709|"~     This study will aid in the development of a research instrument for rapid and highly~     sensitive detection of perinatal salivary oxytocin, by non-invasive means. There will be two~     study cohorts: Induction of labor cohort (20) and Cesarean delivery cohort (5) for a total of~     25 participants.The standard clinical protocols for administering oxytocin to human subjects~     at Lucile Packard Children's Hospital will be followed. Oxytocin will be prescribed and dosed~     as per standard of care with no change due to study enrollment. The study will only involve~     sampling of saliva and blood.~      The general hypothesis to be tested is that 1) the sensor will accurately report the levels~     of oxytocin in saliva samples as compared with standard reference methods and 2) the sensor~     yields rapid (<20 minutes) oxytocin results with minimal discomfort to subjects. Overall,~     this will allow to optimize the administration of oxytocin, and for a better understanding of~     the blood concentration and effects of oxytocin on mother and child.~   "
32571|NCT03140696|"~     This formative research seeks to explore the use of egg (as a potential source of protein) as~     nutritional supplement for young children aged 6-8 months of either sex and breast milk~     composition of mothers of infants under 6 months old living in an urban slum of Dhaka city,~     Bangladesh.~   "
32572|NCT03140683|"~     In recent decades, the percentage of Cesarean section deliveries has dramatically increased~     in most countries. Concomitantly, the rates of vaginal birth after Cesarean have decreased~     steadily.~      The pregnant women with previous Cesarean section face a difficult choice for their next~     delivery between a trial of labor after Cesarean or repeat caesarean section delivery.~      The performance of multiple Cesarean section exposes women to greater risks of complications;~     furthermore, the risk of complications increases with each subsequent Cesarean section.~      In fact, women with previous Cesarean section are more likely to experience short and~     long-term maternal complications in future pregnancies, or a trial of labor after Cesarean,~     with the risk of [uterine dehiscence, uterine rupture, genitourinary tract damage, hemorrhage~     and hysterectomy, abnormal placentation (placenta previa and placenta accreta) and~     difficulties during surgery~   "
32573|NCT03140670|"~     The main purpose of this study is to look at the effectiveness, safety, and antitumor~     activity (preventing growth of the tumor) of the experimental study drug rucaparib (also~     known as CO-338) on subjects and on their pancreatic cancer.~   "
32585|NCT03140514|"~     In this study investigators will investigate whether early treatment of allograft rejection,~     as detected by urine CXCL10-monitoring, improves outcomes in renal allograft recipients.~   "
32593|NCT03140410|"~     Understanding the emergence of linezolid-resistance in Staphylococci has been allowed in the~     past years through the discovery of the clonal dissemination of a chromosomal cassette~     carrying a modified crf gene. New mutations have even been described. Though, clinical~     evidences are still lacking, especially concerning the factors associated to this emergence.~     It could seriously become quite problematic to eliminate one of the last therapeutic weapon~     at our disposal for the treatment of severe or complicated infections caused by resistant~     strains of Staphylococci and Enterococci.~      We aim to describe the mechanisms that permitted to this resistance to become clinically~     significant, concerning meticillin-resistant Staphyloccocus epidermidis strains causing blood~     stream infections in ICU patients, and show the clinical risk factors associated with it~     through a case-control study on patients hospitalized in two ICUs of our hospital between~     2011 and 2016.~   "
32574|NCT03140657|"~     Ankylosing spondylitis is a chronic autoimmune disease in which T cells associated with the~     disorder. The disease often affects the spine and hip bones. Inflammation involved in the~     area of the sacrum - Sacroiliac hip joints, pelvis, spinal lumbar, thoracic and cervical.~     Curcumin is a polyphenol. It is an active component of turmeric which is a perennial plant.~     Curcumin binding with a range of protein and the have ability to inhibit the activity of~     various kinases. Curcumin has a combination of activities such as antioxidant,~     anti-proliferation, anti-invasive, and can used in the treatment of Alzheimer's, Parkinson's,~     Multiple sclerosis, Cardiovascular disease, Bacterial diseases and Arthritis and ankylosing~     spondylitis. This increases the solubility of curcumin in nanomicelles spherical water to~     more than 100 thousand times, which significantly enhances the absorption of curcumin. A~     group of circulating miRNA in plasma is found to be the change they can be involved in~     inflammation or inhibit it. MiRNA expression profiles in blood and serum samples taken from~     patients with ankylosing spondylitis review that is miRNA-326 also affects cells of the~     immune system may be involved in disease ankylosing spondylitis. MiRNA-326 induces~     differentiation of Th17 cells via specific transcription factors, such as the RoRγt. MiRNA326~     increased the expression of transcription factor RoRγt and Th17 cell differentiation TCD4 +~     cells resulting in the production of inflammatory cytokine IL17 increased inflammation and~     progression of inflammatory disease ankylosing spondylitis (AS).~   "
32575|NCT03140644|"~     The goal of this study is to evaluate the diagnostic agreement between, on the one hand,~     ultra-low dose CT and MRI with UTE pulse sequences, and on the other hand, standard CT scan,~     to quantify lung parenchyma patterns in thoracic sarcoidosis.~   "
32576|NCT03140631|"~     The objective of this study is to evaluate the safety, efficacy and efficiency of rapid~     anticoagulation reversal with protamine sulfate versus routine ACT monitoring in patients~     undergoing catheter based ablation of atrial fibrillation.~   "
32577|NCT03140618|"~     The care environment influences both patients' experiences of care as well as staff's~     experiences of the work environment. A radical change in physical environment is planned at a~     psychiatric ward, aiming at creating a care environment that supports patients' opportunities~     for recovery from mental ill-health and to create a better and more attractive work~     environment for the staff. The rebuilding involves a new ward layout and new innovations such~     as light installations, a comfort room and an activity room.~      The study uses a single-system design to evaluate the effects of the intervention - the~     rebuilt ward. Both quantitative and qualitative data will be used in the evaluation. Data~     will be collected using questionnaires measuring dimensions of patients' well-being and~     experiences of the care environment, staff's experiences of work-related stress and work~     environment, quality of care, a device measuring physical activity, existing clinical~     registers and data from medical files, staff' sick leave, participant observations, and~     semi-structured interviews.~      This evaluation study, to our knowledge the first of it's kind in Sweden, is expected to~     generate important knowledge of the effect of the change process that can be used at other~     psychiatric wards to design the inpatient care environment. In the long run, the study could~     lead to a better reputation of psychiatric nursing and to more attractive workplaces.~   "
32578|NCT03140605|"~     Familial hypercholesterolemia (FH) [heterozygous (heFH) or homozygous FH (hoFH)] is a common~     genetic disorder, characterized by elevated plasma low density lipoprotein (LDL) cholesterol~     concentration leading (if untreated) to cholesterol deposits in the corneas, eyelids and~     extensor tendons, rapidly progressing vascular disease, and aortic valve disease.~   "
32579|NCT03140592|"~     Pancreatic cancer is a very aggressive cancer. Over the past 40 years there has not been much~     progress made in reducing deaths from this cancer. Recently, new models of pancreatic cancers~     have been generated from mouse and human tissues. These models have used larger pieces of~     tissues taken from surgical removal of pancreatic cancers.~      The purpose of this study is to determine whether these new pancreatic cancer models can be~     generated from the small biopsies we take to make the diagnosis of the pancreatic mass.~   "
32580|NCT03140579|"~     This study evaluates the effect of airway pressure release ventilation (APRV) on lung~     homogeneity and recruitment in patients with moderate to severe acute respiratory distress~     syndrome (ARDS).~      It will do this by comparing the homogeneity of ventilation and recruitment prior to a~     patient being ventilated on APRV, and at 30, 60 and 120 minutes after starting APRV.~   "
32581|NCT03140566|"~     CAVA-ADHF is designed as a prospective, randomized, controlled, patient-blinded, multicenter,~     parallel-group trial. The objective is to test whether evaluation of the inferior vena cava~     diameter in addition to clinical assessment is superior compared to clinical assessment alone~     with respect to the surrogate endpoint of change in NT-proBNP from baseline to discharge. The~     CAVA-ADHF trial is supported by the Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK).~   "
32582|NCT03140553|"~     Both TCH (docetaxel/carboplatin/trastuzumab) and EC followed by~     TH(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab) regimens as Neoadjuvant~     Treatment for HER2-Positive Breast Cancer have been recommended by NCCN guideline. It is~     unknown which regimen is better. This study is to evaluate the efficacy and safety of TCH~     (docetaxel/carboplatin/trastuzumab) and EC followed by TH(epirubicin/cyclophosphamide~     followed by docetaxe plus trastuzumab) regimens as Neoadjuvant Treatment in HER2-Positive~     breast cancer. The endpoint of pathologic complete response is used as a surrogate marker for~     survival. Safety and tolerability assessed by number of grade 4 toxicities and~     hospitalizations.~   "
32583|NCT03140540|"~     Transesophageal echocardiography (TEE) as guide for tailoring perioperative fluid therapy to~     achieve individualized hemodynamic endpoint, target hemodynamic goals of stroke volume index~     (SVI) greater than 35 mL/m2 and cardiac index greater than 2.5 L/min/m2 and tissue oxygen~     delivery.~      Lactate levels as a surrogate indicator of organ perfusion as measured by arterial blood gas~     analysis intraoperatively, after 12 hours and 48 hrs postoperatively~   "
32764|NCT03138161|"~     This is an open label, dose-seeking phase 1/2 study using escalating doses of TRABECTEDIN~     given intravenously with defined doses of IPILIMUMAB and NIVOLUMAB based on preliminary~     results of the Checkmate 012 trial for NSCLC (Hellman et al., 2016). For the Phase 1 Part of~     Study, only previously treated patients will be enrolled. For the Phase 2 Part of Study,~     previously untreated patients will be enrolled.~   "
32586|NCT03140501|"~     The goal of our study is to evaluate the use of a self-management application (app) that~     the investigators have developed to help facilitate self-management among individuals with~     SCI who live in the community. The main purpose is to create and fulfill individual~     self-management goals. Other purposes include improving self-management and health conditions~     related to SCI.~      During the initial phase, participants (SCI clinicians and patients with SCI) reported~     positive usage of the self-management app and all agreed it would benefit people with SCI.~     With the widespread use of portable electronic devices, an opportunity exists to help~     patients and informal caregivers on the journey from rehabilitation to integration back into~     the community. The investigators will use a randomized controlled trial (randomly putting~     participants into two groups), including both surveys and interviews. The study will involve~     the use of the app that focuses on the self-management of SCI, along with five to six~     in-person or telephone meetings over a three-month period.~      Our proposal is original in that it will be one of the few randomized control trials for~     e-health interventions for self-care management for those with SCI. The overall goals of the~     study is to develop an affordable self-management app that can be used to encourage~     self-management in people living with SCI. This app would be used along with other health~     problem specific apps that are more detailed and expensive, while helping participants to~     manage their long-term health problems related to their SCI in an easily usable and~     affordable form.~   "
32587|NCT03140488|"~     Obesity is considered one of the biggest public health concern of the 21st century and~     increases the risk of many comorbid medical conditions. Obesity in pregnancy places women at~     higher risk of obstetrical complications during pregnancy, delivery and postpartum. In~     particular, obese pregnant women have more difficulty going into labor, a longer labor~     course, and even with pharmacologic treatment, have a higher chance of requiring cesarean~     delivery.~      When pregnant women need help going into labor, they commonly receive a medication called~     Pitocin on the labor and delivery floor. Pitocin is the brand name and is a synthetic analog~     to the naturally produced oxytocin, a hormone secreted by mother when they naturally go into~     labor. This medication has been used widely around the world. There is emerging evidence that~     obese women need more oxytocin to go into labor compared to their lean cohorts. There are~     many studies to support the use of different oxytocin dosages and are currently supported by~     the American College of Obstetricians and Gynecologists. Despite these evidences, a low dose~     oxytocin regimen is universally used in the United States, regardless of patient~     characteristics.~      This study is a double blinded randomized controlled trial. Both lean and obese cohorts will~     be recruited for the study. The investigators will randomly place both cohorts into the low~     or the high dose oxytocin regimen treatment group. The investigators, patients and providers~     will be blinded and will not know the specific assignments. The purpose of this study is to~     evaluate the effect of high dose oxytocin in the obese cohort. The hypothesis is that obese~     patient will have shorter time to delivery with the high dose oxytocin regimen without~     incurring any additional risks or adverse outcomes.~   "
32588|NCT03140475|"~     Metacognition is the ability to introspect and report one's own mental states, or in other~     words to know how much one knows. It allows us to form a sense of confidence about decisions~     one makes in daily life, so one can commit to one option if our confidence is high, or seek~     for more evidence before commitment if our confidence is low. Although this function is~     crucial to behave adequately in a complex environment, confidence judgments are not always~     optimal. Notably, individuals with schizophrenia are prone to overconfidence in errors and~     underconfidence in correct answers. In schizophrenia, confidence is less correlated with~     performance compared to controls.~      These aspects are held to be at the origin of delusions, disorganization, poor insight into~     illness and into cognitive deficit and poor social functioning.~      Our study aims at identifying the cognitive and neural processes involved in metacognitive~     deficits in schizophrenia. Participants will perform metacognitive judgments on a low-level~     perceptual task (visual motion discrimination). Participants will do the first-order~     perceptual task by clicking on the correct answer with a mouse. During the first order task~     completion, the investigators will record several behavioral, physiological and neural~     variables. Then, participants will perform the metacognitive task with a visual analog scale.~      The study will address four research questions:~        -  Q1: is schizophrenia associated with a decrease in metacognitive efficiency? Is the~          metacognitive deficit due to under- or over-confidence?~        -  Q2: is the metacognitive impairment reflected at a decisional level as measured by~          behavioral variables (mouse tracking and reaction times)?~        -  Q3: which physiological markers (EEG, skin conductance, heart rate) are predictors of~          metacognitive efficiency in individuals with schizophrenia and healthy controls?~        -  Q4: which clinical symptoms correlate with metacognitive deficits?~      The investigators make several hypotheses related to the previous research questions:~        -  Q1: the investigators expect metacognitive deficits in schizophrenia, based on results~          from several studies using both qualitative and quantitative measures. The investigators~          will rule out that quantitative deficits are not confounded with impairments in type 1~          performance, with a generalized cognitive deficit in schizophrenia (lower premorbid and~          current Intelligence Quotient (IQ), and deficits in executive functioning and~          particularly in planning and working memory abilities), with depression or with~          statistical flaws during analysis of confidence.~        -  Q2: the investigators expect behavioral cues (mouse tracking and reaction times) to be~          less correlated with confidence in patients vs. controls. The investigators thus make~          the hypothesis that the metacognitive deficit in schizophrenia may stem from an~          inability to integrate pre-decisional cues while performing an explicit metacognitive~          judgment.~        -  Q3: the investigators expect physiological cues (EEG with Error-Related Negativity,~          Lateralized Readiness Potential and alpha suppression, and arousal of the autonomic~          nervous system with skin conductance and heart rate ) to be less correlated with~          confidence in patients vs. controls.~        -  Q4: based on previous findings, the investigators expect that several clinical~          dimensions of schizophrenia may correlate with metacognitive performance. The~          metacognitive deficit would be greater for patients with high levels of positive and~          disorganized symptoms, and greater for patients with low levels of clinical and~          cognitive insight, and low levels of social functioning.~   "
32589|NCT03140462|"~     To study the influence of donor's ABCB1、CYP3A4、CYP3A5、POR genetic polymorphism on tacrolimus~     blood concentration in liver transplant recipients.~   "
32590|NCT03140449|"~     The aim of the study is to determine the effect and safety of topical rapamycin or calcitriol~     and their combination for the treatment of TSC-associated facial angiofibroma.~      Methods: A total of 52 TSC patients including 20 male and 32 female subjects were recruited,~     and 50 of them completed the period 1 study. In period 1, topical rapamycin (0.1%) or~     calcitriol (3 mcg/g) single-agent therapy versus their combination were applied twice a day~     by a left-right randomized, split-face comparison for 12 weeks. The primary end point was the~     reduction of facial angiofibroma severity index (FASI) for the grade of erythema, papule~     size, elevation and extension of the lesions at week 12. In period 2, the patients entered an~     open-label study and were reassigned to use the more effective ointment on both cheeks for~     another 12 weeks (week 13-24). A follow-up FASI analysis for recurrence after drug~     discontinuance for 12 weeks was also performed (week 36). The secondary end point was the~     reduction of Visual Analysis Score (VAS) evaluated by the subjects themselves at week 12.~   "
32591|NCT03140436|"~     This study was designed to find out the stain removal efficacy and also, to find out the~     operators and patients opinion when use or receive treatment with both air polishing powders.~   "
32592|NCT03140423|"~     The Swap Out Trial is a cluster randomized controlled trial of HCA hospitals, evaluating the~     non-inferiority of two decolonization regimens:~      Arm 1 Routine Care: ICU nasal decolonization with mupirocin twice daily for 5 days in the~     context of chlorhexidine for daily bathing; Arm 2 Intervention: ICU nasal decolonization with~     iodophor twice daily for 5 days in the context of chlorhexidine for daily bathing Note: that~     enrolled subjects represents 137 individual HCA Hospitals (representing ~235 ICUs) that~     have been randomized.~   "
32594|NCT03140397|"~     The prenylflavonoids 6-prenylnaringenin (6-PN) and 8-prenylnaringenin (8-PN) are secondary~     plant substances, almost exclusively found in hops (Humulus lupulus). Both compounds have~     known potential biological properties, but poor bioavailability due to their low oral~     absorption and retention. Our study followed a single dose (500 mg 6- or 8-PN), placebo~     controlled, randomized, double-blind, three armed crossover study design with ≥2-week washout~     periods. Plasma, PBMC and urine samples were collected at intervals up to 24 h after intake.~     Investigators investigated the safety, pharmacokinetics and impact of oral prenylflavonoids~     on the function of cells of the immune system.~   "
32595|NCT03140384|"~     In France, drug-induced abortion is allowed up to 9SA, after which the surgical route is~     preferred. Mifepristone 600mg is used 36-48 hours before the introduction of Misoprostol.~     This is recommended orally at a dose of 400 μg. There are currently several studies on the~     subject, including a meta-analysis of the 2011 Cochrane Database, but doses, routes of~     administration and gestational age differ in all studies. Currently, HAS recommends the~     vaginal route at the dose of 800μg for stopped pregnancies. It is therefore necessary to~     compare the different routes of administration of Misoprostol at the same dose to allow to~     change our French recommendations on the medicinal abortion and perhaps also to recommend the~     vaginal route in this indication.~   "
32596|NCT03140371|"~     Oral nutritional supplements and enteral tube feeds are commonly used to meet the nutritional~     requirements of patients with disease-related malnutrition, or who require medical nutrition~     support for other reasons. Some patients may not tolerate standard formulations containing~     whole proteins (typically due to maldigestion/malabsorption) leading to gastrointestinal~     symptoms (i.e. vomiting and diarrhoea). Without appropriate management, this may lead to~     reduced nutritional intake, increased nutritional losses and risk of malnutrition in patients~     who may already have elevated nutritional requirements due to their clinical conditions.~      Poor tolerance to standard feed formulations can be managed with extensively hydrolysed~     (peptide-based) enteral feeds, where the protein source is provided in smaller proteins.~     Patients with elevated nutritional requirements, poor tolerance, maldigestion and/or~     malabsorption often require a higher energy, higher protein feed to meet their nutritional~     requirements in a smaller volume of feed.~      The study feed is a high energy (1.5kcal/ml), high protein (7.5g protein/100ml) peptide-based~     feed, available as a 500ml enteral tube feed, and a 200ml Vanilla-flavour oral nutritional~     supplement. The study will investigate the gastrointestinal tolerance, compliance and~     acceptability of the high energy, high protein peptide-based feed in 60 adult patients~     requiring a peptide-based feed, in several NHS sites across England. Patients will be asked~     to take the study feed for 28 days. Data will be recorded using questionnaires with no~     invasive measures.~      The primary outcome is gastrointestinal tolerance with secondary outcomes of compliance,~     acceptability, nutrient intake and anthropometry.~   "
32597|NCT03140358|"~     Study of low dose atropine in preventing the onset and progression of myopia in high risk~     children with pre-myopia or low-myopia.~   "
32598|NCT03140345|"~     The aim of this two-year study is to explore the relationship among function of HVA,~     nail-fold capillaries and TCM constitutions based on hybridizing data mining techniques. This~     study will not only improve our understanding on the expressions of function of HVA, nailfold~     capillaries and tendency of TCM patterns, but also demonstrate the fundamental knowledge of a~     novel healthcare model on hemodialysis vascular access.~   "
32599|NCT03140332|"~     Hepatocellular carcinoma (HCC) is a hypervascular tumor. The reference treatment of advanced~     forms of stage C according to the Barcelona classification (BCLC C) is sorafenib, a~     multi-target tyrosine kinase inhibitor with predominant anti-angiogenic action. In order not~     to underestimate the efficacy of sorafenib, scannographic evaluation of the tumor response~     should be performed with mRECIST criteria that are significantly better correlated with~     survival. These criteria take into account the tumor size and also the modification of the~     tumor contrast enhancement after anti-angiogenic treatment. It seems appropriate to evaluate~     tumor control rather than tumor response since sorafenib is more stable than tumor response.~      This evaluation will be made according to the mRECIST criteria after 3 months of treatment~     since the progression-free survival is of the order of 3 to 4 months. The determination of~     early predictive criteria for the response to sorafenib would optimize the management of~     advanced HCCs. Indeed, sorafenib only improves overall survival by 3 months in selected~     patients, and with undesirable effects and a significant cost. Predictive biological criteria~     have already been studied, such as alpha foeto-protein (AFP), whose early decrease with~     sorafenib is associated with better overall survival. The same applies to the early reduction~     at 4-6 weeks of tumor arterial contrast according to mRECIST criteria. The perfusion scanner~     appears to be an accessible and reproducible choice imaging technique for assessing tumor~     vasculature. In metastatic kidney cancers, it was demonstrated that some criteria for tumor~     perfusion prior to treatment with sorafenib were predictive of better control of the disease~     and even a better tumor response according to the RECIST 1.1 criteria. The determination of~     pre-therapeutic tumor perfusion criteria in order to predict tumor control or even overall~     survival has never been studied in advanced CHCs. On the other hand, an early variation in~     the criteria for tumor perfusion under treatment would tend to be correlated with the tumor~     response and even with overall progression-free survival.~      Therefore, the study of tumor vascularization by the perfusion scanner could make it possible~     to demonstrate early predictive criteria for tumor control under sorafenib in order to~     optimize the management of patients with advanced HCC.~   "
32600|NCT03140319|"~     The study evaluated the safety and efficacy of the Autologous cultured fibroblast for~     correction of Nasolabial folds and inhibition of skin aging~   "
32601|NCT03140306|"~     This study aims to assess the use of low dose CT reconstructed with MBIR for the assessment~     of patients with inflammatory bowel disease who need CT to assess for disease complications.~   "
32602|NCT03140293|"~     Chorionic villous sampling is a frequent procedure used for antenatal genetic testing. This~     procedure is associated with anxiety and fear of pain that can be expected during the~     procedure, often prejudicing patients against this definitive antenatal testing. It is~     important to determine if different approaches to pain and anxiety reduction are effective.~     Currently there is no randomized study to evaluate the efficacy of analgesia for pain~     reduction during chorionic villous sampling. Multiple studies have been published suggesting~     that analgesia during the similar procedure of amniocentesis does not significantly reduce~     pain scores.~   "
32603|NCT03140280|"~     This is a phase II, single-group pilot study to evaluate efficacy and pharmacokinetics. This~     study's overarching aim is to evaluate the systemic effects of black raspberries in patients~     with myelodysplastic syndrome. Twenty-one patients with MDS will be treated with 25 gm~     (2x/day) of BRB powder taken orally.~   "
32817|NCT03137472|"~     The aim of the current study is to assess the efficacy of TMS in the treatment of Complex~     Regional Pain Syndrome (CRPS). It is hypothesized that participants who receive TMS (Group 1)~     relative to sham treatment (Group 2) once daily for two days will demonstrate a greater~     improvement in CRPS-related pain and other associated symptomology (i.e., cognitive,~     emotional and physical) compared to baseline. Participants will be followed until they reach~     their baseline for two consecutive weeks to assess safety and duration of symptom~     alleviation.~   "
32604|NCT03140267|"~     Ventilator-induced diaphragmatic dysfunction appears to contribute to slow weaning from~     mechanical ventilation. Several trials of inspiratory muscle training to facilitate weaning~     in intensive care have been performed, with inconsistent results, utilizing different methods~     of IMT in different populations.~      To perform the best IMT program, we need to know the physio-pathology of the diaphragm in~     difficult to wean patients.~      This study proposes to discriminate the two main characteristics of the inspiratory muscles:~     strength and endurance.~      By analyzing the evolution of strength and endurance during all the weaning period, we want~     to know which characteristic has the more deficiency to adapt in a second time an effective~     program of IMT.~   "
32605|NCT03140254|"~     The purpose of this study is to evaluate the safety and effectiveness of a topical antiseptic~     for preoperative skin preparation~   "
32606|NCT03140241|"~     After conduction a pilot study, pupillary dilation reflex (PDR) is measured in response to~     nociceptive stimulation perioperatively.~   "
32607|NCT03140228|"~     Sore throat is minor but well recognized complaint after receiving general anaesthesia. It is~     rated as 8th most undesirable outcome in postoperative period.It not only affects the~     patient's satisfaction but also can affect patient activities after leaving hospital.~      Many factors can contribute to postoperative sore throat and the incidence has been found to~     vary with the method by which airway is managed.~      The study is conducted to compare the severity and frequency of postoperative sore throat in~     children undergoing elective surgery following the use of AmbuAuraOnce LMA and I-Gel. The~     study will be done in children who are able to self-report the severity of sore throat.~      This study will help us to determine which supraglottic device (I-gel vs. AmbuAuraOnce LMA)~     is better in terms of causing less complication spells of sore throat. The use of such device~     will not only reduce the severity and frequency of postoperative sore throat that may affect~     the activities of patient after leaving hospital but also will improve satisfaction level of~     patient and parents.~   "
32608|NCT03140215|"~     The study aimed to compare safety of the 3rd generation Supra-glottic airway device (SAD)~     Baska to the I-Gel , regarding seal pressure, fitting on the larynx (detected by~     Fiberoptic) & complications. The study will be done for females undergoing minor~     gynecological procedures under general anesthesia with spontaneous ventilation.~   "
32609|NCT03140202|"~     Context: Chest compressions quality is known to be essential in cardiopulmonary~     resuscitation. Despite a known harmful effect of chest compressions interruptions, current~     guidelines still recommend provider switch every 2 minutes. Feedback impact on chest~     compressions quality preservation during cardiopulmonary resuscitation remains to be~     assessed.~      Study design: simulated prospective monocentric randomized crossover trial.~      Participants and methods: Sixty five professionals rescuers of the pre-hospital care unit of~     University Hospital of Caen (doctors, nurses and ambulance drivers) are enrolled to performed~     continuous chest compression on manikin (ResusciAnne®, Laerdal), twice, with and without a~     feedback device (CPRmeter®). Correct compression score (the main criterion) is defined by~     reached target of rate, depth and leaning at the same time (recorded continuously).~      Hypothesis: Feedback device preserve chest compression quality above the 2 minutes~     recommended switch over during cardiopulmonary resuscitation.~   "
32610|NCT03140189|"~     Minimally invasive esophagectomy (MIE) have become increasingly popular in esophageal cancer.~     It is generally accepted that comparing to open resections, MIE results in decreased~     postoperative pain, faster recovery times, and shorter hospital stays with comparable~     oncologic outcomes. However, MIE poses an important challenge for established thoracic~     surgeons as it is a difficult technique to become skilled at with an protracted learning~     curve. Standard laparoscopic and thoracoscopic instruments are rigid and provide a finite~     freedom of movement with a two dimensional visualization of the operating field. Such a~     difficulty is increased even more when the Ivor-Lewis esophagectomy with an intrathoracic~     anastomosis is needed.~      Robot- assisted surgical system has opened a new era of minimally invasive surgery. Robot-~     assisted surgery offers some advantages including high- definition three- dimensional~     visualization and 7 degrees of freedom with the use of its surgical wrists, motion scaling,~     and tremor filtration, allowing the surgeon to perform complex operations comfortably in the~     domain of urinary tract, hepatobiliary and gynecological surgery. Although a robot-assisted~     thoraco- laparoscopic minimally invasive esophagectomy (RAMIE) was initiated from 2003, the~     published experience with RAMIE remains small, especially for Ivor- Lewis approaches. The aim~     of this study was to investigate the short- term and long-term outcomes of RAILE to identify~     any clinical or oncologic benefits of RAILE in esophageal cancer.~   "
32611|NCT03140176|"~     OPTIMISE is designed to provide knowledge regarding the use of Sunitinib as 1st line~     treatment and 2nd line treatment selected (Sunitinib-different sequence) with respect to~     efficacy outcomes, adverse events, and health related QoL in the real life setting.~   "
32612|NCT03140163|"~     The ULTRACHEST study will be a prospective clinical diagnostic performance study with primary~     objective to establish device diagnostic clinical performance of Ultra Low Dose CT (ULD-CT)~     in order to prove it is more accurate in detecting pneumonia when comparing to standard~     conventional chest radiography.~   "
32613|NCT03140150|"~     Follow-up strategy for patients implanted with a pacemaker.~   "
32614|NCT03140137|"~     The tolerance of immune checkpoint inhibitors is unknown in patients with pre-existing~     autoimmune conditions. This retrospective nation-wide study will assess their tolerance in~     patients with pre-existing autoimmune conditions who received immune checkpoint inhibitors~     for an advanced cancer in clinical practice.~   "
32628|NCT03139955|"~     Bodytrak® is a wireless earpiece which can monitor the user's vital signs such as tympanic~     (ear) temperature and heart rate. The earpiece is non-invasive and should fit comfortably~     within the right ear, similar to an earphone with an over-the-ear hook. Bodytrak is currently~     in a prototype stage.~      The purpose of this study is to assess the feasibility of conducting a trial investigating~     the integration of Bodytrak in an NHS (National Health Service) environment at Chelsea and~     Westminster Hospital; to collect patient vital sign data for the development of Bodytrak~     algorithms to detect the transition point of recovery/deterioration of health, as well as the~     level of consciousness; and to obtain nurse and patient feedback regarding their user~     experience of Bodytrak.~   "
32818|NCT03137459|"~     The purpose of this study is to examine the effect of an individually transtheoretical model~     (TTM) tailored intervention on the completion of advance care planning (ACP) behaviors.~   "
32615|NCT03140124|"~     Several studies have noted the benefits of exercise programs in improving both mood and~     anxiety symptoms. Additionally, single bouts of exercise have been shown to improve mood and~     anxiety. Business applications report ancillary benefits of exercise as well. For example,~     individuals spontaneously report better ability to approach stimuli and cope with emotional~     experiences if doing it while exercising.~      The current study aims to investigate exercise during a therapy session as a potential~     intervention for enhancing therapeutic learning, particularly ability to better cope with~     emotional topics and experiencing intense emotions. In this study, patient participants will~     complete a therapy session while using an exercise machine and a separate therapy session~     while using a worry stone (control). Both patient participants and therapist participants~     will make ratings of a variety of items, including ability to discuss emotional topics and~     comfort in experiencing emotions.~      Investigators hypothesize that patients will report better ability to discuss emotional~     topics and more comfort in experiencing emotions following the exercise condition as opposed~     to the worry stone condition. Investigators also hypothesize that therapist ratings will~     similarly indicate that patients were better able to discuss emotional topics and experience~     emotional content during exercise sessions.~   "
32616|NCT03140111|"~     Single-blind, randomised, single centre, 2-way crossover pilot study to investigate the~     effectiveness of LAMELLEYE for the treatment of dry eye symptoms in patients with primary~     Sjögren's Syndrome.~   "
32617|NCT03140098|"~     The aim of this observational study is to evaluate the safety of the guided healing and~     adhesion prevention membrane, COVA™+ CARD, in adult cardiac surgery. The causality of the~     collagen membrane according to the occurrence of peri and post-operative complications will~     be evaluated.~   "
32618|NCT03140085|"~     Urinary tract infections are among the most prevalent microbial diseases and their financial~     burden on society is substantial. The use of bacteriophages against bacterial pathogens has~     gained over the last years a renewed interest, because of the continuing increase in~     antibiotic resistance worldwide. Thus, the aim of this study is to investigate the efficacy~     of intravesical bacteriophage treatment to normalize urine culture compared to intravesical~     placebo or standard antibiotic treatment.~   "
32619|NCT03140072|"~     In this integrated, multi-part, Phase I study, the safety, tolerability, food effect,~     pharmacokinetic (PK) and pharmacodynamic (PD) properties of single and repeated doses of~     AZD9898 will be investigated.~   "
32620|NCT03140059|"~     The aim of this study will be to compare the approach of repeated applications of APDT versus~     surgical therapy for the treatment of residual pockets in generalized agressive~     periodontitis.~   "
32621|NCT03140046|"~     Irregular astigmatism is one of the most serious and frequent complications of corneal~     refractive surgery and one of the worst sequelae of other forms of corneal surgery . It is~     also considered as one of common, serious complications of corneal injuries .~      Spectacle correction is usually not useful in the correction of corneal irregular~     astigmatism. Contact lenses represent a good alternative, but their adaptation and stability~     are limited by the irregular corneal surface and patient discomfort.~      In recent years, advancements in laser technology have offered better tools for dealing with~     irregular astigmatism with finding new surgical methods to improve corneal regularity for the~     correction of irregular astigmatism.~      Topography-linked excimer laser is a potentially effective technique in the treatment of~     irregular astigmatism after keratoplasty . In fact, customized ablation was shown to be an~     effective means of treatment of irregular astigmatism due to different etiologies Such as~     corneal Injuries , scar , or postoperative.~      Some of the theoretical advantages of topography-driven photorefractive keratectomy (PRK) are~     a better astigmatic correction, the possibility of correcting irregular astigmatism, and a~     smaller ablation volume compared with standard treatments, resulting in better visual~     performance.~      Aim of the work To evaluate the efficacy, safety, and predictability of topography-guided~     photorefractive keratectomy (PRK) to improve refractive status of patient with irregular~     Cornea.~   "
32622|NCT03140033|"~     Sublingual Misoprostol to Reduce Blood Loss During Elective Cesarean Delivery : A Randomized~     Controlled Trial~   "
32623|NCT03140020|"~     The aim of this proposal is to investigate the effects of uneventful microsurgical and~     endovascular treatment of unruptured saccular non-giant anterior communicating artery [ACoA]~     aneurysms on resting state functional connectivity levels of higher order cognitive networks~     and to correlate the connectivity levels of these networks with neuropsychological~     performance and functional outcome.~      This study compares two treatment groups and one control group.~   "
32624|NCT03140007|"~     Primary Objective: To assess the diagnostic accuracy of cholangioscopy-based assessment using~     SpyDS technology compared to cholangiography-based assessment using ERCP-guided biopsy and~     brushing in patients with indeterminate biliary strictures in the setting of~     cholangiocarcinoma.~   "
32625|NCT03139994|"~     The cause of temporomandibular joint disorders remains unknown. It is considered~     multifactorial and includes physical (peripheral) and psychosocial (central) factors. It has~     been showed an association: a steeper condylar path, flatter lateral anterior guidance, and~     habitual chewing on the symptomatic side. This finding argues the possibility of causation of~     some of these characteristics. This double blind longitudinal study aims to assess if the~     presence of one habitual chewing side could contribute to temporomandibular joint disorders~     over time.~      Method. Young adults with no signs or symptoms of TMD will be assessed. Participants with one~     chewing side (observed and interview); with steeper condylar path and lower lateral guidance~     angles will be considered consistent one side chewers, and this side will be considered more~     susceptible to suffer TMD. Mouth opening, hemispheric dominance and hemimandibular~     retrognathia will be considered as secondary pre-specified outcomes. Four years later, both~     TMJs of each participant presenting signs and/or symptoms will be evaluated according to~     DC/TMD.~   "
32626|NCT03139981|"~     This is a dose escalation study to test the safety, tolerability and preliminary efficacy of~     ASN002 in people with moderate to severe atopic dermatitis (AD).~   "
32627|NCT03139968|"~     The RECAP-trial is a randomized controlled, double blinded, superiority trial studying the~     efficacy of the RADPAD®, a protective drape, that potentially reduces the scattered radiation~     received by the operator during diagnostic angiograms and percutaneous coronary~     interventions.~   "
32629|NCT03139942|"~     Small growths detected in the colon (polyps) during a colonoscopy may or may not have the~     potential to develop into cancer. However, since visual inspection alone cannot separate all~     potentially harmful polyps from harmless ones, the standard approach is to remove them all~     for histological lab examination, exposing patients to risk of injury and putting a~     significant demand on hospital resources. An accurate method of determining polyp type during~     endoscopy would enable the clinician to only remove potentially harmful polyps. A new~     endoscopic optical imaging probe (OPTIC), which analyses how light interacts with tissue, is~     proposed to do this. The probe is contained within a normal endoscope and uses white light~     and blue/violet laser light to illuminate the tissue. The reflected and fluorescent light~     emitted, along with normal colour pictures of the polyp surface, are measured and recorded to~     quantify specific characteristics of each type. Optical measurements of polyps detected in~     endoscopy clinics at Imperial College Healthcare NHS Trust will be analysed to determine if~     the signal can be used to differentiate different polyp types.~   "
32630|NCT03139929|"~     To study the reliablity of MSFP and stressed volume to follow volume loading and to predict~     fload loading responsiveness in patients after elective coronary artery bypass grafting~     (CABG) surgery.~   "
32631|NCT03139916|"~     This research study is studying a combination of drugs with radiation as a possible treatment~     for Glioblastoma.~      The drugs involved in this study are:~        -  Bavituximab~        -  Temozolomide~   "
32632|NCT03139903|"~     The purpose of this study si to define morphological and epidemiological parameters and~     identify new symptoms in French patients with Seckel syndrome (SCKL) or microcephalic~     osteodysplastic primordial dwarfism type II (MOPDII).~   "
32633|NCT03139890|"~     Vascular function decreases following the intake of a mixed meal in some, but not all~     studies. Differences in the relative amounts of dietary fat, carbohydrates and protein~     present in the mixed-meal challenges may have contributed to these apparently inconsistent~     results. Well-designed trials - comparing under rigorously standardized conditions - on the~     effects of macronutrients on postprandial vascular function are missing. The primary~     objective of the current study is thus to evaluate in overweight and slightly obese men the~     effects of the three macronutrients (fat, carbohydrates, and protein) on postprandial~     vascular function, as assessed by brachial artery flow-mediated vasodilation (FMD). Secondary~     objectives are to examine postprandial effects on other markers reflecting vascular function,~     plasma markers for low-grade systemic inflammation and endothelial dysfunction, blood~     pressure, and serum lipid and plasma glucose metabolism.~   "
32634|NCT03139877|"~     Using an observational case-control cohort design, the investigator aims to define the~     mechanisms underlying microbiome regulation of metabolism in adolescence before and after~     medically indicated therapies for obesity. The investigator's overarching hypothesis is that~     gut bacteria control host weight, insulin sensitivity, and response to weight-loss treatments~     by modifying host metabolism.~   "
32635|NCT03139864|"~     The type 1 diabetes is a common chronic disease characterised by the stop of production of~     insulin by the pancreas. A lot of factors modify blood glucose. The objective is to study the~     effect of type 1 diabetes on the use of energy substrates (fats and carbohydrates) during~     exercise of increasing intensity by a comparison with non-diabetic controls children.~   "
32636|NCT03139851|"~     The investigators hypothesize that the administration of pembrolizumab combined to metronomic~     cyclophosphamide may be an interesting therapeutic option for female patients breast cancer~     with lymphopenia.~      Include only patients with breast cancer with lymphopenia is based on the particularly poor~     prognosis of these patients. The approach suggested here is to deplete and active the immune~     response of these immunosuppressed patients. The combination of pembrolizumab and~     cyclophosphamide would provide a higher gain in anti-tumor response in these patients than in~     those without lymphopenia and in chemotherapy alone.~      The investigators proposal is to conduct a multicentric, non-comparative, single arm,~     two-stage, Phase II trial in lymphopenic patients with metastatic breast cancer.~      The study is divided in 2 parts:~        -  a safety run-in Phase aiming to evaluate the safety of the combination therapy~          pembrolizumab + metronomic cyclophosphamide based on the occurrence of severe~          toxicities.~        -  a two-stage Phase II aiming to evaluate the clinical activity of the combination therapy~          pembrolizumab + metronomic cyclophosphamide.~      In both parts of the study, patients will receive cyclophosphamide (50 mg/day, daily, per os)~     and pembrolizumab (200 mg every 3 weeks, intravenously [IV]). The adverse events of the two~     drugs are well known.~   "
32637|NCT03139838|"~     This is a pragmatic, stepped-wedge, cluster randomized trial testing the real-world~     effectiveness of two different electronic health record (EHR) behavioral interventions in~     improving a number of patient- and family-centered processes and outcomes of care among~     seriously ill hospitalized patients. The investigators hypothesize that outcomes can be~     improved without raising costs by requiring intensive care unit clinicians to (i) document a~     prognostic estimate and (ii) provide a justification if they choose not to offer patients the~     option of comfort-oriented care. To test this hypothesis the investigators will conduct a~     33-month trial at 19 intensive care units in 10 hospitals using the same Cerner EHR within~     Carolinas HealthCare System.~   "
32638|NCT03139825|"~     The disruption of social cognition associated with borderline personality disorder (BPD), and~     more specifically categorization of facial emotions, remains largely under-studied, despite~     the high frequency of this pathology in the clinical population. The first results differ~     from the observations made in adults and this confirms the relevance of studying this theme~     specifically in adolescence. On the cognitive level, there is a disturbance of the detection~     and the categorization of the facial emotions in the TPL. The characteristics of this~     disturbance and its possible association with an attack on the connectivity of the brain~     remain unknown in adolescence. No functional imaging studies are published in adolescent TPL.~     This pilot bimodal functional imaging study EEG-NIRS aims to collect preliminary and~     feasibility data to support a response to upcoming PHRC competitions and eventually offer a~     science thesis opportunity.~   "
32639|NCT03139812|"~     This study sought to determine whether daily irrigation with sterile saline solution during~     silicone hydrogel (SiH) contact lens continuous wear (CW) could improve ocular surface~     integrity and reduce the risk of adverse events.~   "
32640|NCT03139799|"~     This study aims at investigating the effects of tablet-based puzzle video games on cognitive~     function and emotional well-being. This study extends preliminary findings of studies looking~     at short-term benefits of playing puzzle video games to a long-term intervention in healthy~     older adults and patients suffering from cognitive impairment due to mild cognitive~     impairment or acquired brain injury. To this end, the investigators compare two~     interventions: A tablet-based puzzle video games experimental intervention and a control~     intervention tablet newspaper-reading control intervention. This study uses a 16-week,~     assessor blinded, randomized crossover design with two phases of treatment and three waves of~     measurement. Participants are randomly allocated to either the experimental or control~     intervention for 8 weeks, then interventions are crossed over. Both groups receive both~     interventions in opposite order. At three time points (pre-, mid- and post-test) higher~     cognitive function and emotional well-being are tested using standardised neuropsychological~     tests and questionnaires.~   "
32641|NCT03139786|"~     The aortic valve bicuspidia (BVA) is a congenital condition corresponding to the presence of~     2 sigmoids instead of 3. This is the most common cardiac congenital anomaly affecting 0.5 to~     2% of the population The general rule. BVA may be associated with structural damage to the~     ascending aorta, which exposes BVA patients to a risk of developing ascending aortic aneurysm~     and acute aortic accidents. Recent data from the literature have revealed that the natural~     history of BVA is marked by a possible development towards significant valvulopathy and / or~     an ascending aortic aneurysm often requiring surgical treatment. However, the natural history~     of bicuspid disease remains poorly understood and the prognostic factors for progression to~     severe valvulopathy and / or aneurysmal dilatation of the ascending aorta remain to be~     determined.~   "
32642|NCT03139773|"~     The long-term objective of this study is to determine if habitual consumption of high-quality~     protein at breakfast will lead to improved energy metabolism and decreased daily energy~     intake in normal weight and overweight children. The investigators hypothesize that~     increasing protein intake at breakfast will improve energy metabolism and reduce energy~     intake throughout the day in overweight/obese school-aged children. The significance of the~     study is that improving nutrient intake at breakfast can potentially lead to a future~     reduction in childhood obesity rates.~   "
32643|NCT03139760|"~     POWERSforID is a 24 week randomized control trial designed to assess the feasibility of a~     telehealth and coaching intervention for improving health outcomes of adults with~     intellectual disability. Recruitment is conducted through a disability health clinic located~     in Colorado Springs, CO.~   "
32644|NCT03139747|"~     This is a Phase 2 Study of Everolimus and Lenvatinib in patients with metastatic~     differentiated thyroid cancer who have progressed on lenvatinib alone. Patient will have~     imaging, lab test and physical exams~   "
32645|NCT03139734|"~     The purpose of this study is to find out if sacral neuromodulation is an effective treatment~     for pelvic pain associated with surgically treated endometriosis.~   "
32646|NCT03139721|"~     This study is being conducted to satisfy the post-CE approval requirement.~   "
32647|NCT03139708|"~     This an interventional study looking at two different sequences of pre-operative eye drops,~     to determine which order is more effective in reducing intraocular pressure with pupil~     dilation.~   "
32648|NCT03139695|"~     Mechanical ventilation can be life saving strategy for patients with respiratory failure due~     to a variety of reasons. Once the underlying illness has resolved, intensive care doctors~     have to take a decision on when the patient is safe to get off the ventilator or be~     extubated. They use clinical assessment of the patient's ability to breathe spontaneously and~     make use of some breathing parameters to make the judgment. Most of the time, a patient can~     come off the ventilator and do well, but sometimes muscle weakness from sickness can affect~     the patient's ability to breathe adequately once ventilator support is discontinued. If that~     occurs, the patient may have to be put back on the ventilator and the physician will suggest~     some changes to help muscles get stronger. A simple, non-invasive test that can assess~     respiratory muscle state before taking patients off the ventilator to see if their muscles~     look healthy can help distinguish which patients may not be ready to be extubated. There are~     currently several tests available to assess muscle strength, in particular muscles that help~     in breathing like the intercostal muscles and diaphragm. The study will test the use of~     Ultrasonography (Ultrasound) as a non-invasive test to assess the muscles of respiration.~     This test will also help the investigators test physical therapies and interventions of~     mechanical ventilation that can help patients strengthen the muscles while waiting for~     extubation.~   "
32649|NCT03139682|"~     Traumatic brain injury (TBI) is a leading cause of death and disability around the world. The~     social and economic burden of TBI is tremendous and the cost of TBI is estimated at $1~     billion per year in Canada- $650 million in care and $580 million in lost productivity. Novel~     interventions aimed at TBI-linked molecular targets have been successful in limiting injury~     and improving neurologic recovery in animal models, thus providing compelling evidence that~     effective intervention is possible after injury. This study proposes to investigate traumatic~     microvascular injury (TMI) and specifically blood-brain barrier dysfunction (BBBD) as a~     candidate biomarker and therapeutic target in TBI.~   "
32650|NCT03139669|"~     Invasive cervical cancer incidence and mortality can be dramatically reduced through early~     detection and treatment, but many women do not complete screening at recommended intervals.~     Many low-income women in Virginia remain uninsured and are at significant risk of being~     medically underserved and failing to complete regular cervical cancer screening. At-home~     self-collection of specimens for HPV testing is an innovative approach that may increase~     access to cervical cancer screening in populations that do not participate in traditional~     clinic-based screening. The proposed community based participatory study aims to determine~     whether offering at-home self-collection for HPV testing through a lay navigator network is~     an acceptable and feasible method to increase access to cervical cancer screening for~     under-screened women in the Tobacco Footprint in rural far Southwest Virginia (Health~     Districts 1, 2 and 3). The procedures will be recruitment of under-screened women in Health~     Districts 1, 2 and 3 of Southwest Virginia to complete HPV testing using self-collection kits~     distributed by lay navigators. Regardless of HPV positivity, all women will be provided with~     information about cervical cancer screening (locations, cost, etc.), and will be encouraged~     to complete Pap screening by a clinician.~   "
32651|NCT03139656|"~     This study will investigate three interventions—values clarification, planning, or combined~     (values clarification + planning)—for increasing goal-consistent health behavior (e.g.,~     exercise or dieting). The investigators will also examine how intervention effects differ~     based on various psychological and neuropsychological factors, to better understand how~     interventions can be tailored to specific individuals.~      The investigators hypothesize a) that the combined intervention will increase goal-consistent~     exercise behavior more than the other interventions; and b) that individuals scoring higher~     on self-concordance or goal-commitment will benefit more from planning, whereas those with~     more positive expectancies or scoring higher on neuropsychological measures (e.g., working~     memory) will benefit more from values clarification.~   "
32652|NCT03139643|"~     The current study aims to investigate two potential interventions (i.e., cognitive dissonance~     and action planning) for inducing behavior change for behaviors important to college~     students—studying and exercise. In addition, this study will investigate factors that may~     impact behavior change, such as psychological and neuropsychological variables, to better~     understand how to bridge the intention-behavior gap.~   "
32653|NCT03139630|"~     Evaluation of the impact of initiation of protease inhibitor/ritonavir on PCSK9 levels in~     HIV-infected antiretroviral-naïve patients from the ANRS C09 COPANA cohort.~   "
32654|NCT03139617|"~     This study aimed to evaluate the efficacy of ultrasound guided femoral 3 in 1 block versus~     the blind technique single shot fascia iliaca compartment block as an analgesia method in~     patients prior positioning for spinal anaesthesia in femur fracture surgery. A total of 60~     patients were enrolled and divided equally into 2 groups.~   "
32655|NCT03139604|"~     The purpose of this study is to evaluate itacitinib or placebo in combination with~     corticosteroids as first-line treatment of participants with Grade II to IV acute~     graft-versus-host disease (aGVHD).~   "
32656|NCT03139591|"~     This study aimed to compare the efficacy between lidocaine inhalation vs intravenous~     dexamethasone to reduce pain after laryngeal mask insertion~   "
32657|NCT03139578|"~     This will be a 2 period one-day, double-masked, randomized, repeated measures,~     non-dispensing, cross-over study where the main purpose of this study is to compare the~     performance of a new daily disposable silicone hydrogel lens with that of an existing similar~     lens.~   "
32658|NCT03139565|"~     The study will test whether a high dose influenza vaccination results in improved~     immunogenicity in adult SOT recipients as compared to standard vaccine. This will be a single~     center prospective observer-blind randomized controlled trial conducted at the Toronto~     General Hospital Multi-Organ Transplant Unit, University Health Network, Toronto, Ontario,~     Canada.~   "
32659|NCT03139552|"~     This study aims to reduce the amount of sugar in a particular food item and add spices to see~     if the food liking of that item rates as high or higher in a post meal survey. Through taste~     testing of the menu items (using sequential monadic CLT methodology) the investigators will~     determine an opinion of the participants. Results of these surveys will determine whether~     participants enjoy the reduced sugar options as much as their full sugar counterparts.~   "
32660|NCT03139539|"~     This is a randomized, controlled study which aims to show whether iodine impregnated~     incisional foil (IobanTM) has a place in the prevention of prosthetic joint infection (PJI).~     1200 patients will be included in this study and will be followed through out a ten year~     period.~      Follow up will center on the function of the prosthetic knee, early and late infection rates~     and revision surgery due to aseptic loosening.~      Our purpose is to gain insight in to the causes of post-operative infection in joint~     alloplasty surgery. Our hypothesis' are:~        1. The patient's skin flora is the main source of intraoperative contamination,~        2. Intraoperative contamination can be reduced by using IobanTM~        3. Intraoperative contamination strongly predicts postoperative infection~        4. Unsuccessful clinical outcomes of knee arthroplasty are caused by low-grade infections.~      To our knowledge this is the first study with this large a sample size and as long a follow~     up.~      Background PJI is a devastating complication with substantial morbidity and high socio~     economic costs. Revision surgery due to infection costs as much as six times more than the~     primary surgery and has a poorer outcome for the patient i.e. disability, pain or loss of~     function.~      Methods and materials~      The study has two main arms:~        1. Intraoperative contamination~        2. Postoperative infection~      The first stage aims to document that patients with intraoperative contamination have a~     larger risk of developing postoperative infection and include a study of the effect of~     Ioban™.~      The second stage are to include methods of PCR (polymerase chain reaction) and fluorescence~     microscopy, to demonstrate bacterial contamination and/or infection of any implants removed~     during the study period.~      Perspectives This study will give us new insight in the causes of PJI and the correlation~     with contamination during surgery. If IobanTM is proved to prevent infection it is a simple~     way to prevent post-operative infection and can be implemented in any orthopedic department.~   "
32661|NCT03139526|"~     Craniopharyngioma is a rare, benign central nervous system tumor, which may be a source of~     multiple complications, from endocrinology to vision, neurology and neurocognitive functions.~     This morbidity can lead to reduced participation in life activities, as described in the~     International Classification of Functioning, Disability, and Health (ICF). The primary~     objective of this study is to measure participation in life activities in a population of~     children affected by childhood craniopharyngioma, using the assessement of life habits~     questionnaire (LIFE-H questionnaire), validated as a social participation measurement tool in~     various pediatric disabilities.~   "
32662|NCT03139513|"~     This is a multicentre, ambispective (both retrospective and prospective), and~     non-interventional study conducted in France in adult participants with BRAF V600~     mutation-positive unresectable or metastatic melanoma treated with cobimetinib in combination~     with vemurafenib (Zelboraf®).~   "
32663|NCT03139500|"~     The purpose of this study is to evaluate the safety and tolerability and pharmacokinetics of~     JNJ61803534 in healthy participants after administration of single ascending oral doses of~     JNJ-61803534 (Part 1) and multiple ascending oral doses of JNJ-61803534, administered for 14~     consecutive days (Part 2) as well as the potential of JNJ-61803534 to interact with other~     drugs (Part 3).~   "
32664|NCT03139487|"~     This is an open label, multi-center, and randomized phase II trial designed to compare the~     safety and efficacy of oral rivaroxaban and subcutaneous dalteparin in patients with acute~     venous thromboembolism and upper gastrointestinal, hepatobiliary, or pancreatic cancer, based~     on a group sequential design. Enrolled patients will be randomized in a 1:1 ratio. Patients~     will be stratified by performance status (ECOG performance status 0-1 versus ≥2) and type of~     cancer.~   "
32684|NCT03139227|"~     This pilot clinical trial studies the side effects and best dose of apigenin in increasing~     health benefits in high risk breast clinic patients. Celery is high in apigenin, a compound~     that may have anti-cancer activities. Eating a celery-based diet may help in prevention and~     treatment of inflammatory diseases including cancer.~   "
32665|NCT03139474|"~     The first In-Vitro Fertilization cycles were performed in natural unstimulated cycles. Today~     gonadotrophins are administered to induce multiple follicular development and controlled~     ovarian hyperstimulation. During ovarian stimulation gonadotrophin-releasing hormone~     analogues are co-administered in order to prevent premature luteinizing hormone surges.~     Premature luteinizing hormone surges are observed in about 20% of stimulated cycles without~     using gonadotrophin-releasing hormone analogues .~      Avoiding the adverse effects of elevated luteinizing hormone levels, first~     gonadotrophin-releasing hormone agonist analogues were used to supplement the gonadotrophin~     stimulation. The continuous administration of gonadotrophin-releasing hormone agonists causes~     gonadotrophin suppression through down-regulation and desensitization of the~     gonadotrophin-releasing hormone receptors in the pituitary gland after an initial short~     period of gonadotrophin hypersecretion .~      Gonadotrophin-releasing hormone antagonists (cetrorelix and ganirelix) cause immediate and~     rapid gonadotrophin suppression by competitive antagonism of the gonadotrophin-releasing~     hormone receptor in the pituitary without an initial period of gonadotrophin hypersecretion.~     Several advantageous effects of cetrorelix were established , and these effects seemed to be~     independent from the type of antagonist used for luteinizing hormone-suppression.The quality~     of oocytes and developing preembryos is one of the most relevant factors determining the~     success of an In-Vitro Fertilization treatment. As ovarian stimulation protocol is one of the~     eligible factors during an In-Vitro Fertilization treatment, its embryo quality influencing~     effects are necessary to know.~   "
32666|NCT03139461|"~     The goal of the study is to develop and test an intervention toolkit to increase the~     enrollment in EnhanceFitness (an evidence-based group physical activity program for older~     adults) at Young Men Christian Association (YMCA) sites through physical therapist referrals.~      A cluster-randomized trial will be used to compare current and intervention toolkit~     approaches to generating enrollment in EnhanceFitness at YMCAs. The objective of this trial~     is to compare the effectiveness and cost of the current approach for generating enrollment in~     EnhanceFitness (business as usual or control arm) with the intervention toolkit that YMCA~     staff will use to engage physical therapists to refer their older adult patients to~     EnhanceFitness (the intervention).~   "
32667|NCT03139448|"~     Nasal continuous positive airway pressure (nCPAP) has been shown to effectively relieve upper~     airway obstruction in patients with OSA as it creates a pneumatic stent in the hypopharynx~     that reduces obstruction and allows for continuous oxygenation. Nasal ventilation was also~     proven to be more effective than combined oral-nasal ventilation during induction of general~     anesthesia in adult subjects. However, it is not clear if nasal mask can be used safely for~     oxygenation and ventilation in patients undergoing colonoscopy.~      The SuperNO2VA™ device is a new commercially available nasal mask that provides both nasal~     CPAP and nasal mask ventilation. The objective of this study is to compare the efficacy of~     oxygenation and ventilation during colonoscopy using the novel nasal mask, SuperNO2VA™, and~     standard care with nasal cannula.~   "
32668|NCT03139435|"~     This pilot clinical trial studies how well ultrasound works in detecting taxane-induced~     neuropathy in patients with breast cancer. Ultrasound may work better in diagnosing and~     detecting neuropathy in breast cancer patients treated with the chemotherapy drug called a~     taxane.~   "
32669|NCT03139422|"~     Intrauterine contraceptive device is the most commonly reversible method used among women of~     reproductive age worldwide. Almost one in five married contraceptive users is currently using~     Intrauterine contraceptive device. The Egyptian demographic and health survey results~     indicate that 30% of currently married women interviewed in the Egyptian demographic and~     health survey were using Intrauterine contraceptive device. Main reasons for discontinuation~     of Intrauterine contraceptive device as cited by women were excessive bleeding per vagina~     39.68%, abdominal pain 38.62%, low backache35.97%.~   "
32670|NCT03139409|"~     This study will be conducted to compare the effect of chlorexidine containing adhesive versus~     conventional one in prevention of secondary caries lesion underneath composite restoration~     over one year follow up null hypothesis~   "
32671|NCT03139396|"~     Patients with missing back teeth can be restored with an inlay retained bridge.The inlay~     retained bridge designs include inlay shaped, tub shaped or proximal box shaped.In this study~     a clinical evaluation will be commenced to evaluate two designs the inlay shaped and the tub~     shaped.The hypothesis of our trial is that the new design may show longer survival rate due~     to less stress applied on the restoration which allow the restoration to function for longer~     period as the inlay shaped bridge showed clinical problems during survice.~   "
32672|NCT03139383|"~     The investigators tested the hypothesis that administration of intravenous dextrose as a~     maintenance fluid in gynecologic laparoscopic surgery would reduce the incidence and severity~     of postoperative nausea and vomiting (PONV) compared with normal saline solution in the same~     dose.~      A prospective randomized double blinded controlled study was conducted. Eighty six~     participants were randomized to dextrose solution (n= 42) or normal saline solution (n= 44).~     The Bellville postoperative nausea and vomiting scores were recorded until 24 hours after~     surgery.~   "
32673|NCT03139370|"~     Participants who are HLA-DPB1*04:01 positive and whose tumors are MAGE-A3/A6 positive may be~     eligible for this study. If eligible, white blood cells are collected by apheresis and~     genetically modified to recognize cancer cells which express MAGE-A3/A6. Chemotherapy~     precedes infusion of the genetically modified cells. Participants may be hospitalized and/or~     return to the study doctor for check-ups and medical evaluations. The purpose of the study is~     to see if the treatment is safe and effective in treating advanced cancer.~   "
32685|NCT03139214|"~     This study aimed to test the effect of a parenting intervention on metabolic syndrome in~     African American youth. The investigators hypothesized that a parenting intervention would~     produce reductions in metabolic syndrome, particularly for those families that started out~     high in difficulties with parenting.~   "
32686|NCT03139201|"~     The objective of this study is to demonstrate that the OxyAqua silicone hydrogel soft contact~     lens could be prescribed as a supportive care for myopes.~   "
33093|NCT03133871|"~     The aim of this study is to establish whether the use of a special digital camera (SIAscopy)~     can provide an accurate and reliable measure of vitiligo which is at least equivalent to the~     current gold standard of planimetry. If so, SIAscopy could be used as an objective diagnostic~     and prognostic tool in the management of vitiligo patients within dermatology departments and~     allow a fair and accurate assessment of new potential treatments.~   "
32674|NCT03139357|"~     Stress and anxiety can worsen quality of life in patients seen in primary care practices.~     Patients at predetermined practices age 20-65 receive psychosocial screening instruments for~     anxiety and quality of life (GAD7 and SF-12) at six month intervals for twenty-four months as~     part of routine care. Assessing anxiety and quality of life every six months will provide~     data to analyze whether anxiety and quality of life changes over time.~      Patients who consent will also be asked at 6, 12, 18, and 24 months about medical utilization~     of behavioral care or any medical care outside of University of Pittsburgh Medical Center in~     order to be part of their research record for good clinical care. If patients received any~     behavioral treatment, the patient will also be asked questions regarding the helpfulness of~     this treatment.~      This is an observational characterization study to understand the psychiatric and behavioral~     needs of primary care patients. The follow-up questionnaires and medical record information~     will look at the rates and predictors of hospitalizations and/ or behavioral health treatment~     as a longitudinal way to track these symptoms over time. These resources are critical to~     determine the need for embedded behavioral care in primary care settings.~   "
32675|NCT03139344|"~     Skeletal muscle is the largest endocrine organ in the body, playing an indispensable role in~     glucose homeostasis. Spinal cord injury (SCI) prevents skeletal muscle from carrying out this~     important function. Dysregulation of glucose metabolism precipitates high rates of metabolic~     syndrome, diabetes, and other secondary health conditions (SHCs) of SCI. These SHCs exert a~     negative influence on health-related quality of life (HRQOL). New discoveries support that a~     low level of activity throughout the day offers a more effective metabolic stimulus than~     brief, episodic exercise bouts. The proposed study will translate this emerging concept to~     the population of individuals with SCI by using low-force, long-duration electrical muscle~     stimulation to subsidize daily activity levels. Recently, we demonstrated that this type of~     stimulation up-regulates key genes that foster an oxidative, insulin-sensitive phenotype in~     paralyzed muscle. We will now test whether this type of activity can improve glucose~     homeostasis and metabolic function in patients with chronic paralysis. We hypothesize that~     improvements in metabolic function will be accompanied by a reduction in SHCs and a~     concomitant improvement in self-reported HRQOL. The long-term goal of this research is to~     develop a rehabilitation strategy to protect the musculoskeletal health, metabolic function,~     and health-related quality of life of people living with complete SCI.~   "
32676|NCT03139331|"~     This is the first study to evaluate the safety and clinical activity of the combination of~     oral pazopanib, intravenous or oral irinotecan, and oral temozolomide in pediatric and young~     adult patients with relapsed or refractory sarcomas. This study will use a 3 + 3 design for~     dose escalation (Part 1), followed by an expansion cohort (Part 2) at the recommended phase 2~     dose level.~   "
32677|NCT03139318|"~     The primary objective of this study is to evaluate the toxicity profile of GRID therapy using~     dose levels of 10Gy, 15 Gy and 20Gy in pediatric osteosarcoma of the extremity.~   "
32678|NCT03139305|"~     The main purpose of this study is to examine the effect of prolonged (72 hour) administration~     of glucagon compared to placebo on energy expenditure in healthy, non-diabetic, obese~     subjects.~   "
32679|NCT03139292|"~     Comparison of two different supraglottic airway devices i.e., the ProSeal Laryngeal Mask~     Airway (PLMA) and Ambu AuraGain, a third generation laryngeal mask Airway.~   "
32680|NCT03139279|"~     An ideal sedative for colonoscopy should have properties that include: rapid onset and offset~     of action, provide cardiopulmonary stability, have minimal adverse effects, and allow for~     smooth recovery, and early discharge. Propofol is often used solely because of its rapid~     onset and short duration of action---a property which is ideal for a fast recovery and early~     discharge in the ambulatory setting. However, the use of propofol has been associated with~     undesirable effects such as hypotension, hypoventilation and apnea requiring assisted~     ventilation.~      Balanced anesthesia, using a combination of medications with different mechanisms of action~     can reduce the total amount of each sedative agent used and minimize their side effects while~     achieving the desired level of sedation. Dexmedetomidine is one agent that has been used~     either alone or in combination with propofol for sedation during colonoscopy. While there are~     many advantages to using dexmedetomidine, there is concern that the use of this agent for~     sedation during colonoscopy may prolong post-operative recovery time and readiness for~     discharge home.~      No study has definitively assessed whether the use of dexmedetomidine in combination with~     propofol during ambulatory colonoscopy prolongs post-operative recovery time as determined by~     the Modified Post Anesthesia Discharge Scoring System (MPADSS).~   "
32681|NCT03139266|"~     People with CF have elevated rates of anxiety and depression when compared to the general~     population. Anxiety and depression can have a negative impact on adherence and disease~     self-management, leading to worse CF health outcomes such as respiratory symptoms, functional~     capacity, and health-related quality of life (HRQOL).~      Project UPLIFT is a group mental health intervention that can be delivered by telephone or~     Web, though for this study the intervention will be web based only. Project UPLIFT was~     originally developed as a depression treatment and prevention program for people with~     epilepsy and was shown to be effective in reducing depression and increasing knowledge and~     skills. Recently, Project UPLIFT was revised to help people with CF manage their depression~     and anxiety and shown to be apparently successful in a pilot study that included adolescents~     and adults with CF.~      The goals of this project are to determine the effectiveness of Project UPLIFT in reducing~     anxiety and depression in adolescents and adults with CF, as well as increasing their quality~     of life and other physical health-related disease outcomes.~   "
32682|NCT03139253|"~     Helicobacter pylori (H. pylori), which infects about 50% of the global population, has been~     recognized as a main risk factor of multiple gastric pathologies, especially non-cardiac~     gastric cancer. Strongly evidence supports that H. pylori eradication is an effective~     approach to reduce the incidence of those pathologies.~   "
32683|NCT03139240|"~     Our primary objective will be to determine if a strong opioid, oxycodone, given at a dose~     recommended for severe pain in addition to ibuprofen decreases maximum pain scores compared~     to ibuprofen and placebo in women undergoing medical abortion (MAB). Results of this study~     will help future providers understand whether prescribing opioids are an important adjunct~     for pain control in women undergoing MAB.~   "
32687|NCT03139188|"~     The course of care of a patient with a cancer whose evolution is pejorative, is marked by~     difficult announcements, called bad news. In the palliative phase, prognostic announcements~     are at the forefront. Of these, the announcement of a transfer to the Palliative Care Unit~     has not been the subject of any specific studies to the best of our knowledge. It therefore~     seemed interesting to us to explore the stakes of this particular announcement, a source of~     upheaval for the doctor and the patient, by gathering the point of view of each one.~      The objective of our study is to analyze the methods of announcing a transfer to the~     Palliative Care Unit and the perception of this announcement by the doctor and his patient~     with an incurable cancer.~   "
32688|NCT03139175|"~     Investigate the relationships between temporomandibular disorder and low back pain~   "
32689|NCT03139162|"~     The project aims at deriving frailty (FI) and complexity (CI) indices from data collected~     with the Resident Instrument Assessment - Home Care adapted for Switzerland (RAI-HC). Data~     were collected in 2015 by trained nurses in clinical routine with the primary purposes of~     health state assessment and individual home care planning. The study consists in a~     retrospective secondary analysis of health data from the Minimal Data Set (MDS), used to~     derive frailty and complexity indices according to published definitions and guidelines for~     index derivation. The analysis further aims at estimating the predictive power of these~     indices on undesirable health outcomes (falls, hospitalizations and deaths). The goal is to~     provide home care institutions and nurses valid algorithms to compute useful clinical~     indicators without additional assessment that the one routinely done with the RAI-HC.~   "
32690|NCT03139149|"~     This study will compare the results of early surgery after 12 h conservative treatment and 48~     h conservative treatment of adhesive small bowel obstruction.~   "
32691|NCT03139136|"~     Rheumatoid arthritis (RA) affects 1 percent of the population worldwide and up to 40 percent~     of patients don't respond to current treatments. MBS2320, the drug being tested in this~     trial, represents a new approach to treating RA, with the potential not only to reduce levels~     of inflammation but to also directly prevent bone damage.The aim of this project is to test~     the safety, tolerability and efficacy of MBS2320 in patients with RA in combination with an~     existing treatment, methotrexate.~   "
32692|NCT03139123|"~     Per-dialytic hypotension is common in Intensive Care Unit patients under continuous renal~     replacement therapy, and occurs in nearly 50% of the patients. To date, there is a lack of~     study having characterized the underlying mechanism of hypotension in this setting. New~     diagnostic methods are now available with high reliability to identify hypovolemia as the~     underlying cause of hypotension, among which change in cardiac index during passive leg~     raising may be the less affected by restrictive validity criteria. A change in cardiac index~     greater than 10% during this test is highly predictive of preload dependence, i.e the~     probability than cardiac index will increase if cardiac preload increases.~      The aim of this study is then to identify, among hypotensive episodes occurring during renal~     replacement therapy in Intensive Care Unit patients, the percentage of episodes related to~     preload dependence as identified by passive leg raising.~   "
32693|NCT03139110|"~     Violence in the workplace is becoming a serious phenomenon in the contemporary world of work.~     Hospital staff, like any employee working in contact with the public, is particularly exposed~     to this violence. In emergency departments, the number of patients treated and their~     heterogeneity, the problems of communicating with healthcare professionals, and waiting~     times, favor conflict situations. In the already tense context of the emergencies, the~     incivilities or violent acts have an impact on the well-being of professionals. In order to~     prevent these situations of violence, a solution could be to integrate a professional with~     specific skills into the teams to perform mediation functions between caregivers and~     patients.~      The aim of the study is to evaluate the impact of the presence of a mediator in emergency~     services on personal (verbal or physical) attacks on professionals (caregivers, doctors,~     administrative staff).~   "
32694|NCT03139097|"~     This study will establish reference range intervals for the Quantra System, a next-generation~     diagnostic platform that provides whole blood coagulation testing at the point-of-care.~   "
32695|NCT03139084|"~     The development of disease-targeted drugs for the treatment of pulmonary arterial~     hypertension (PAH) has significantly improved within the last years. Combining drug products~     with different mechanisms of action such as Endothelin-Receptor-Antagonists (ERAs) and~     Phosphodiesterase-Type-5-inhibitors (PDE-5-Inhibitors) has become increasingly important for~     the treatment of PAH. Recently, the results of the AMBITION study reported that an upfront~     combination treatment of ambrisentan and tadalafil immediately after diagnosis leads to a~     delayed disease progression. On the other hand, the sequential combination of bosentan and~     sildenafil did not show a similar positive clinical effect and this was attributed to a~     negative clinically relevant pharmacodynamic drug-drug interaction. Although, recent~     guidelines have extrapolated that initial upfront combination treatment follows a class~     effect in terms of efficacy and safety, there is an imperative need to support this notion~     with other combinations of ERAs and PDE-5-Inhibitors.~   "
32696|NCT03139071|"~     Coffee is one of the dietary factors associated with cardiovascular disease (CVD) but its~     role in the cardiovascular system is not yet clear. Moreover, available evidence for the~     relation between coffee intake with subclinical atherosclerosis is limited and inconsistent.~     The aim of this study was to evaluate the association between habitual coffee consumption and~     the presence of subclinical atherosclerosis measured as coronary artery calcium (CAC) in the~     Brazilian Longitudinal Study of Adult Health (ELSA-Brasil). This is a cross-sectional study~     based on baseline data from participants of the cohort ELSA-Brasil. In this analysis, only~     participants living in São Paulo with no prior history of CVD aged 35 to 74 years who~     underwent a CAC measurement (n=4,426) were included. Dietary data were collected using a~     validated food frequency questionnaire. Coronary calcification was detected with computed~     tomographic and it was expressed as Agatston units. CAC was further categorized as 0 or >0,~     and <100 or ≥100.~   "
32727|NCT03138668|"~     The purpose of this study is to investigate and describe the anatomical differences in~     distribution of the blocked area following a perineural LFCN (Lateral Femoris Cutaneous~     Nerve) block with either 8 ml or 16 ml of Ropivacaine, in relation to incision lines used in~     THA (Total Hip Arthroplasty). Furthermore, we examine any loss of motor function in Musculus~     Quadriceps due to posible involvement of the Femoral Nerve. This trial will be conducted in~     healthy volunteers, as a blinded, randomized, paired trial.~   "
32697|NCT03139058|"~     Tobacco and alcohol are the two major risk factors for upper respiratory tract cancer (VADS).~     Among patients with VADS cancer, more than 60% reported daily alcohol consumption of more~     than 20 g / d. Such poisoning can be harmful, causing histological lesions of alcoholic liver~     disease, such as steatosis, alcoholic hepatitis, liver fibrosis and cirrhosis. In a~     population consuming more than 50 g of alcohol per day for 5 years, the prevalence of severe~     hepatic fibrosis is between 30% and 40%. In the therapeutic management of a cancer of VADS,~     the presence of cirrhosis is a prognostic element, increasing the postoperative risk of~     haemorrhage, surgical site infection and acute renal failure. The search for cirrhosis in the~     pre-therapeutic assessment is therefore important. The diagnosis of cirrhosis is not a~     problem when clinical, biological, radiological or endoscopic signs of hepatic insufficiency~     or portal hypertension are present. Asymptomatic cirrhosis is more difficult to diagnose~     without liver biopsy. Noninvasive hepatic exploration techniques have recently been developed~     and validated for the evaluation of liver fibrosis in the context of alcoholic liver disease.~     Fibroscan® (Echosens, Paris, France) is an imaging device for measuring the liver hardness~     (hepatic elasticity expressed in kPa), with a strong correlation with the presence of~     histological fibrosis of the liver. At the threshold of 19.5 kPa, Fibroscan can be used to~     diagnose cirrhosis with good diagnostic performance (Se 80%, Sp 90%, VPP 93%, VPN 70%) and~     good inter- and intra-observer reproducibility. Elastometry is a simple, reliable and~     non-invasive tool to systematically evaluate hepatic fibrosis in patients with VADS cancer.~     The examination can be performed during a routine care consultation. The post-therapeutic~     morbidity induced by cirrhosis in the cancers of VADS is not well known and there is no~     recommendation in France about the hepatic explorations to be carried out during the initial~     assessment of these neoplasias. It is essential to be able to specify this morbidity in order~     to adapt if necessary the therapeutic strategy of cancers of VADS.~      The objective of this study is to systematically determine the presence of cirrhosis and / or~     liver fibrosis in patients with VADS cancer, in order to investigate their impact on the~     morbidity after treatment of squamous cell carcinomas of the head and neck.~   "
32698|NCT03139045|"~     Peripheral venipuncture is a common procedure in geriatrics. This procedure due to altered~     cutaneous alteration and venous capital associated with age poses problems of comfort and~     quality of life of elderly patients hospitalized. There is little data from the literature~     that highlights the difficulties of venipuncture in the context of old age. New venous~     visualization technologies by infrared spectroscopy (NIR) such as VeinViewer® Vision (VVV)~     have been developed to guide the placement of a peripheral venous (VVP) or venipuncture (PV)~     route.~   "
32699|NCT03139032|"~     The purpose of this phase 2a, proof of concept, open-label clinical study is to evaluate the~     efficacy and safety of etrasimod (APD334) in inflammatory bowel disease patients with active~     skin extra-intestinal manifestations.~   "
32700|NCT03139019|"~     The relative effectiveness of incentives based on process (e.g. medication adherence) vs.~     outcome (improvements in blood pressure) is unknown, leading to the key research question:~     Which approach is more effective? The incentive structure for this initiative is based on~     best practices in the use of process and outcome measures to address this fundamental~     question. A series of incentive designs will be conducted to examine the relative~     effectiveness of equivalent value incentives based on process (e.g. attending smoking~     cessation counseling sessions), outcomes (e.g. quitting smoking), or a combination of process~     and outcomes incentives (e.g. attending smoking cessation counseling sessions and quitting~     smoking). This will also provide an overarching framework for assessing the relative~     importance of process versus outcome incentives in different contexts and for different~     populations.~   "
32701|NCT03139006|"~     Cardiovascular disease remains the leading cause of morbidity and mortality worldwide.~     Coronary computed tomography angiography (CCTA) and, if indicated, invasively measured~     fractional flow reserve (FFR) is currently used for ruling out significant coronary artery~     disease. FFRCT is a novel non-invasive technique in which FFR is derived from CT images,~     however this method is currently, just like CCTA, lacking specificity. Spectral Detector CT~     (SDCT) is a novel technique whereby a spectrum of monoenergetic images at different~     kiloelectron Volt (keV) values (40 to 200 keV) can be reconstructed. By using these~     monoenergetic images, a decrease in blooming and beam-hardening artifacts could be achieved.~     In addition, SDCT offers the opportunity to assess myocardial iodine distribution and~     quantification. When combining these factors, we hypothesize more accurate information will~     be available about the coronary anatomy, degree of stenosis and FFRCT and thereby contribute~     to a more accurate way for the detection of hemodynamic significant stenosis. Therefore, the~     aim of this study is to assess the accuracy of SDCT as a non-invasive way for the detection~     of hemodynamically significant coronary artery stenosis.~      Objective: The overall objective of this project is to assess the accuracy of SDCT for the~     detection of flow limiting stenosis in the coronary arteries using invasive FFR as the~     standard of reference. Whereby different subaims (e.g. improvement of FFRCT) are made to~     answer the overall objective. The secondary objective is to determine the decrease of calcium~     blooming of calcifications and beam-hardening artifacts and the improvement of myocardial~     blood volume quantification on SDCT in comparison with conventional CT.~   "
32702|NCT03138993|"~     This study evaluates the feasibility of conducting a randomized controlled trial that tests a~     patient decision aid for obstructive sleep apnea in older adults with newly-diagnosed~     obstructive sleep apnea treated in an outpatient sleep clinic. Half of the participants will~     use a patient decision aid, while the other half will receive general information about~     sleep.~   "
32703|NCT03138980|"~     The objective of the proposed research is to conduct user testing of a mobile-based~     self-management support intervention for adolescents and young adults with Irritable Bowel~     Syndrome (IBS), a chronic digestive condition. The application (app; BodiMojo Buddy) uses a~     virtual coach that can serve to increase patient engagement through interactive~     skill-building, self-care, and mindfulness-based cognitive behavioral activities. If the~     BodiMojo Buddy mobile app is successful, it will have a significant public health impact by~     providing a mobile resource to the 10-15% of the US population who suffer from IBS and~     potentially improving health outcomes and reducing significant costs to the US healthcare~     system.~      Study participation involves participants downloading and using the app for 30 days. During~     the 30 days, participants will interact with the app by inputting their current mood,~     receiving supportive feedback from the app, reading messages, and doing brief activities~     (such as relaxation activities, etc.). Before and after the 30 days of user testing,~     participants will complete a few brief questionnaires about their behavior, how their~     symptoms affect their life, and how they receive support from others. These questions will~     take around 20 minutes to complete at each administration.~   "
32728|NCT03138655|"~     The purpose of this study is to evaluate vedolizumab pharmacokinetics (PK), safety and~     tolerability in pediatric participants with moderately to severely active UC or CD.~   "
33106|NCT03133702|"~     Objectives: to detect the mistakes and deficiencies of the forensic reports which was written~     and to detect the injury characteristics of the forensic cases applied to emergency service~     of a tertiary hospital.~   "
32704|NCT03138967|"~     The goal of this clinical research study is to determine whether using sugammadex, given with~     a standard muscle relaxation drug during bladder surgeries, improves anesthesia conditions~     and recovery time.~      During some bladder operations, your muscles must be completely relaxed. Muscle relaxation~     drugs cause the muscles to relax, including the respiratory muscles, and as a result~     artificial ventilation is needed to help you breathe. Sugammadex and other standard drugs~     reverse the effect of the muscle relaxation drugs, allowing you to breathe on your own after~     the operation.~      Study Groups:~      If you agree to take part in this study, you will be randomly assigned (as in the flip of a~     coin) to 1 of 2 study groups. This is done because no one knows if one study group is better,~     the same, or worse than the other group:~        -  If you are in Group 1, you will receive sugammadex to reverse the muscle relaxation.~        -  If you are in Group 2, you will receive the standard of care~          (neostigmine/glycopyrrolate) to reverse the muscle relaxation.~      You and the surgeon will not know which group you have been assigned to. However, the~     anesthesiologist and study staff will know.~      Length of Study:~      You will be on study for up to 1 week after the cystoscopy. If you are unable to have the~     procedure performed, you may be taken off study early.~      This is an investigational study. Sugammadex and neostigmine/glycopyrrolate are all FDA~     approved and commercially available to reverse muscle relaxation. The comparison of these~     drugs is investigational.~      Up to 50 participants will take part in this study. All will be enrolled at MD Anderson.~   "
32705|NCT03138954|"~     The aim of the study will be to determine the diagnostic and prognostic value of~     elastosonography and the use of the contrast agent (Sonovue®) in the endoscopic ultrasound~     exploration of deep pelvic endometriosis.~   "
32706|NCT03138941|"~     Lupus Low Disease Activity State (LLDAS) study is an international, multi-centre prospective~     study, developed by the Asia Pacific Lupus Collaboration (APLC) to investigate whether the~     attainment of LLDAS is associated with improved outcomes in patients with Systemic Lupus~     Erythematosus (SLE).~      SLE, or lupus, is the archetypal multisystem autoimmune disease, with an estimated incidence~     of 5-50 cases per 100,000 people. Patients with SLE, usually young women, suffer a marked~     loss of life expectancy, and severe morbidity, due to a heterogeneous range of clinical~     manifestations caused by autoimmune-mediated inflammation of multiple organs. The most severe~     manifestations of SLE are the accrual of irreversible organ damage, especially renal and~     central nervous system (CNS) involvement. As there is no effective targeted monotherapy for~     SLE, patients also suffer severe toxicity from the use of glucocorticoids and broad-spectrum~     immunosuppressive therapies. Despite combination therapy with current drugs, many studies~     show that the majority of patients suffer inadequate disease control and inexorably accrue~     permanent organ damage over time.~      The diversity of clinical features of active SLE has made quantification of disease activity~     problematic. Although there are a number of published systems in use to measure SLE disease~     activity, there are widely acknowledged problems with these instruments. Published~     definitions of remission are so stringent that they are met by less than 5% of patients. This~     lead to the realisation that rather than lupus remission, a lupus low disease activity state~     target may be more feasible, and that patients with low disease activity are more homogeneous~     than patients with active disease. Thus, the development of a definition of lupus low disease~     activity, which is feasible and has face validity, escapes the complexity of attempts to~     quantify heterogeneous states of active disease.~      In this study, the investigators will prospectively collect longitudinal data on consecutive~     SLE patients at each centre to evaluate the LLDAS definition. Protection from organ damage~     accrual as the primary endpoint.~   "
32707|NCT03138928|"~     Purpose: To report the follow-up data for patients who had XEN45 gel stent implantation, a~     new method of minimally invasive glaucoma surgery (MIGS).~      Material and Methods: Fifteen eyes of fifteen patients who had XEN45 gel stent implantation~     surgery were investigated in the study. All the patients were examined preoperatively and at~     the following postoperative time points: 1 day; 1 and 2 weeks; and 1, 2, 3, 6, and 12 months.~     Intraocular pressure (IOP) was measured by Goldmann applanation tonometry. Combined surgical~     procedures (XEN 45 + phacoemulsification + intraocular lens) were performed in the cases that~     had cataracts in addition to glaucoma.~   "
32708|NCT03138915|"~     This is a prospective, multi-center diagnostic trial conducted at 4 high-volume liver centers~     in China designed to determine the diagnostic performance of radiomics-based hepatic venous~     pressure gradient (rHVPG) (investigational technology) by CT angiography (CTA) for~     noninvasive assessment of the clinically significant portal hypertension (CSPH) in patients~     with cirrhosis. Direct hepatic venous pressure gradient (HVPG) measurement by means of~     catheterization of a hepatic vein with a balloon catheter is the gold-standard method to~     assess the presence of CSPH, which is defined as HVPG≥10 mmHg.~   "
32709|NCT03138902|"~     The purpose of this study is to evaluate the validity of using a carbohydrate intolerance~     questionnaire (CIQ) and/or other health markers as a means of predicting response to insulin~     sensitivity as determined by an oral glucose tolerance test (OGTT).~   "
32710|NCT03138889|"~     This study is to assess the safety and tolerability, define the maximum tolerated dose (MTD)~     or recommended phase 2 dose (RP2D) and to assess the preliminary clinical benefit of NKTR-214~     when combined with pembrolizumab (Keytruda®) or atezolizumab (Tecentriq®). Up to 30 patients~     will be enrolled concurrently in each combination arm. NKTR-214 in combination with~     pembrolizumab will be evaluated in select patients with metastatic melanoma, urothelial~     bladder cancer or non-small cell Lung cancer (NSCLC). NKTR-214 in combination with~     atezolizumab will be evaluated in select patients with urothelial bladder cancer or NSCLC.~     Both drugs target the immune system and may act synergistically to promote anticancer~     effects.~   "
32711|NCT03138876|"~     Altered mental status (AMS) is one of the most common reasons for inpatient neurology~     consultation. Non-convulsive status epilepticus (NCSE) is frequently on the differential~     diagnosis of the patient with AMS. NCSE becomes more refractory to treatment after one hour~     of seizure activity, making rapid identification and treatment of NCSE of great clinical~     importance. Currently, an electroencephalogram (EEG) technologist must be called in from home~     during non-workday hours in order to obtain a stat EEG. The investigators propose the time~     required for diagnosis of NCSE at Mayo Clinic can be significantly decreased with rapid~     placement of an EEG cap by the onsite neurology residents.~   "
32742|NCT03138460|"~     Data of patient reported outcomes (PRO) are collected during treatment with various pain~     alleviation methods (drugs or substances)~   "
32819|NCT03137446|"~     IV fluid resuscitation has long been recognized to be an important treatment for patients~     with severe sepsis and septic shock. While under-resuscitation is known to increase morbidity~     and mortality, contemporary data suggests that overly aggressive fluid resuscitation may also~     be harmful. Currently, following an initial IVF resuscitation of 30 ml/kg, there is no~     standard of care and a lack of evidence to support a fluid restrictive or more liberal~     strategy. The investigators seek to determine if a fluid restrictive strategy reduces~     morbidity and mortality among patients with severe sepsis and septic shock.~   "
32712|NCT03138863|"~     Subjects to be enrolled in this study are pregnant women whose unborn baby has been diagnosed~     with severe congenital diaphragmatic hernia (CDH). CDH is a birth defect occurring early in~     pregnancy. It is characterized by the development of a hole in the diaphragm, the breathing~     muscle that separates the chest from the abdomen. As a result, the intestines and other~     organs in the baby's abdomen can move into the chest and press on the developing lungs. CDH~     is a serious condition which prevents the fetal lungs from developing normally.~      The purpose of this study is to gather information on the safety and effectiveness of a new~     procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO). FETO involves two surgical~     procedures while the mother is still pregnant. During the early third trimester of pregnancy,~     a special tiny balloon is placed in the baby's trachea. After the balloon has been in place~     for several weeks, the balloon will be removed during a second procedure, generally done when~     the baby has reached about 34 weeks gestation.~      The intent of the FETO procedure is to improve development of the lungs in fetuses diagnosed~     with severe CDH. If better lung development can be promoted, it is expected that overall~     survival of babies with severe CDH after birth will also be improved.~   "
32713|NCT03138850|"~     The purpose of this study is to compare the effect of mandibular advancement bite block and~     high flow nasal cannula to standard bite block for oxygenation, capnographic measurement,~     prevention of hypoxemia, intervention events and adverse effects during endoscopic~     examinations.~   "
32714|NCT03138837|"~     assess diagnostic performance of 3-Tesla DW-MRI in detecting and staging bladder cancer and~     potential role of the ADC value as a biomarker reflecting histological grade and stage.~   "
32715|NCT03138824|"~     Compare the therapeutic utility of SPIES assisted TURB with WLI assisted TURB in patients~     with non-muscle invasive bladder cancer.~   "
32716|NCT03138811|"~     This is a non-confirmatory, randomized, subject and investigator blinded, placebo-controlled,~     parallel-design, multi-center bronchoprovocation study. Approximately 55 subjects with mild~     stable atopic asthma who exhibit an EAR and LAR to a common inhaled allergen will receive~     multiple once daily doses of inhaled CSJ117 or placebo over 12 weeks. Two sequential dose~     cohorts are planned for this study, Cohort 1 and Cohort 2. Cohort 2 will be split into two~     parts, Cohort 2a and 2b~   "
32717|NCT03138798|"~     Obstetric practices now allow for prolonged second stage of labor to accomplish vaginal~     delivery. However, this practice may lead to either operative delivery (vacuum or forceps~     assisted delivery) or cesarean section with significant maternal/neonatal morbidity. Limited~     evidence suggests that dental support devices (DSD) may improve lead to shortened labor by~     allowing patients to push more effectively.~   "
32718|NCT03138785|"~     In this study, investigators want to find the effect of adjuvant collagen cross-linking in~     the treatment of fungal keratitis~   "
32719|NCT03138772|"~     This is a prospective observational study to follow a cohort of patients with Cystic Fibrosis~     and healthy controls for a period of two years. This study will include monitoring the~     subjects lung clearance index (by performing a breathing test called the multiple breath~     washout), as well as spirometry and their respiratory symptoms every three months as well as~     during a pulmonary exacerbation and after their recovery.~   "
32720|NCT03138759|"~     The primary objective of this trial is to assess the effect of probenecid on the~     pharmacokinetics (PK) of single-dose pexidartinib in healthy subjects.~      Secondary objectives are to assess the safety and tolerability of pexidartinib alone and in~     combination with probenecid.~      Participants will be confined to the clinic for approximately 32 days. Blood samples will be~     collected for PK analysis of pexidartinib and metabolites at predose and up to 312 hours (h)~     post dose.~   "
32721|NCT03138746|"~     In a recent series of studies performed by our group, we have shown that exposure to~     hyperbaric oxygen (HBO) leads to an increase in insulin sensitivity in male subjects with~     type-2 diabetes (T2DM) and in obese and overweight men without diabetes. The aim of this~     study is to investigate the relationship between pressure and oxygen in producing this~     effect, specifically, is this effect measurable in hyperbaric air or is some higher pressure~     of oxygen required?~      Aims:~        1. To determine whether the insulin sensitising effect of HBO is apparent in hyperbaric air~          at the same pressure as HBO.~        2. To examine mechanisms underpinning the increase in insulin sensitivity following HBO.~   "
32722|NCT03138733|"~     The purpose of this study is to compare the efficacy and safety of ceftobiprole medocaril~     versus a comparator in the treatment of patients with complicated Staphylococcus aureus~     bacteremia.~   "
32723|NCT03138720|"~     The purpose of this study is to determine if the combination of paclitaxel protein bound,~     gemcitabine, cisplatin, paricalcitol are effective in individuals with resectable and~     unresectable pancreatic cancer.~   "
32724|NCT03138707|"~     Emergency services are a crowded and chaotic environment.~   "
32725|NCT03138694|"~     Ectopic pregnancies are a common morbidity in the gynaecological field. Previous work done by~     our team has shown the benefits of conservative treatment with only BHCG (Beta-Human~     Chorionic Gonadotropin) monitoring, proving that a vast number of patients will have a self~     resolution without the need for any further medical intervention. In addition, our working~     hypothesis is that this process in contrast to Methotrexate is a more physiologic one with~     less inflammatory and necrosis reaction.~      OBJECTIVE To measure and compare the size of the ectopic mass and monitor BHCG levels of~     women treated with Methotrexate and those that had a self resolution process of their ectopic~     pregnancy.~      Investigators aim to prove that the mass will have an enlargement trend after Methotrexate in~     contrast to being stable or decrease in size with conservative treatment.~   "
32726|NCT03138681|"~     This is a preliminary, double-blind clinical trail aimed to investigate whether the~     combination of fluoxetine with ATP or phosphocreatine has a rapid antidepressant effect. 42~     patients with major depressive disorder (Hamilton Depression Rating Scale (HAMD) score >= 20)~     will be recruited and divided into 3 groups randomly. This study involves two periods. In the~     first period, one group will be treated with fluoxetine and placebo, one with fluoxetine and~     ATP, and one with fluoxetine and phosphocreatine for 2 weeks. Placebo, ATP and~     phosphocreatine will be given intravenously, and fluoxetine orally. In the second period,~     each patient will be only given fluoxetine for 4 weeks.~   "
33107|NCT03133689|"~     The primary aim of this study is to examine if long-term patterns of alcohol consumption are~     associated with time-to-onset for incident coronary heart disease (fatal and non-fatal),~     using data from multiple cohorts.~   "
32729|NCT03138642|"~     In China, mucosal melanoma of head and neck (MMHN) account for 30-40% of all melanoma and the~     incidence is on the rise. The prognosis of MMHN is poor with the 5-year survival in a range~     between 20-30%. The evidence for the treatment of MMHN was weak since large-sample clinical~     researches are rare and no prospective clinical trial is reported. Surgery is the primary~     treatment modality for MMHN. However, it is difficult to extend the necessary surgery range~     for MMHN due to its limitation of being adjacent to the important anatomical structure in~     head and neck or by the considerations of the protection for organ function. As a result, the~     recurrence rate for surgery along was over 50%. Radiotherapy(RT) is the main approach for the~     multidisciplinary treatment for MMHN. Benlyazid et al. conclude the data from 13 centers and~     find that compared to surgery alone, the addition of post-surgery RT improve the survival;~     The 5-year locoregional failure rate for the surgery alone group and the RT+surgery group~     were 55.6% and 29.9%, respectively. Currently, the research into the prognosis factors is~     spare for the non-metastatic MMMHN received extended resection to primary tumor. It is~     necessary to undertake a prospective clinical research for MMHN in the endemic area to~     estimate efficacy and safety of primary surgery plus postoperative radiotherapy with or~     without adjuvant chemotherapy, as well as to recognize the risk distribution in this cohort~     of patients, provide the evidence to improve the stratification treatment strategies in the~     clinic.~   "
32730|NCT03138629|"~     This is an expanded access program (EAP) for eligible participants. This program is designed~     to provide access to VAL-083 (dianhydrogalactitol) prior to approval by the local regulatory~     agency. Availability will depend on territory eligibility. Participating sites will be added~     as they apply for and are approved for the EAP. A medical doctor must decide whether the~     potential benefit outweighs the risk of receiving an investigational therapy based on the~     individual patient's medical history and program eligibility criteria.~   "
32731|NCT03138616|"~     Vitamin D deficiency are related to insulin resistance and impaired beta-cell function.It is~     reported that the level of vitamin D is lower during pregnancy and postpartum in the women~     with Gestational Diabetes Mellitus. The investigators hypothesize that vitamin D~     supplementation to women after birth with previous gestational diabetes may improve glucose~     metabolism.~   "
32732|NCT03138603|"~     The purpose of this research study is to test if a commonly used, FDA-approved medication,~     called metoprolol, given during and after surgery, reduces the possibility of heart related~     complications in patients with CAD.~   "
32733|NCT03138590|"~     The purpose of this study is to investigate whether it is possible to accelerate learning and~     improve associative memory performance in healthy subjects, by applying transcranial Direct~     Current Stimulation (tDCS) targeting the trigeminal nerve during a verbal paired-associate~     learning task~   "
32734|NCT03138577|"~     This clinical trial is for subjects undergoing right upper extremity surgery. The aim of the~     study is to investigate the dose-response relationship between local anesthetic volume and~     ipsilateral hemidiaphragmatic paresis (HDP) in patients getting ultrasound-guided~     supraclavicular brachial plexus blocks in a blinded, prospective trial.~   "
32735|NCT03138564|"~     Despite advances in dialysis, only 50% of dialysis patients are alive 3 years after the onset~     of end-stage renal disease (ESRD). Although withdrawal of dialysis precedes 1 in 4 deaths of~     patients with ESRD, withdrawal from dialysis and aggressive treatment is rarely discussed by~     patients and their surrogates with sufficient time to consider alternatives such as hospice~     or dying at home. Over the last decade, the researchers have developed and iteratively tested~     a patient and family-centered advance care planning intervention based on the~     Representational Approach to Patient Education called Sharing Patient's Illness~     Representation to Increase Trust (SPIRIT). SPIRIT is a 6-step, 2-session, face-to-face~     intervention to promote cognitive and emotional preparation for end-of-life decision making~     for patients with ESRD and their surrogates. In these explanatory trials carried out in~     dialysis clinics, SPIRIT was delivered by trained research nurses. The researchers have~     established feasibility, patient-surrogate acceptability, and efficacy. Patients and~     surrogates participating in SPIRIT showed significant improvement in preparedness for~     end-of-life decision making, and surrogates in SPIRIT reported significantly improved~     post-bereavement psychological outcomes after the patient's death compared to a no treatment~     comparison condition. The logical, critical next step is to ask: Will SPIRIT be effective as~     part of routine care in real-world settings with less control? To address this very issue,~     The researchers will conduct a real-world effectiveness-implementation study. This study is a~     multicenter, clinic-level cluster randomized trial to evaluate the effectiveness of SPIRIT~     delivered by dialysis care providers as part of routine care in free-standing outpatient~     dialysis clinics compared to usual care plus delayed SPIRIT implementation. This study will~     evaluate the implementation of SPIRIT, including sustainability.~      The researchers will recruit 400 dyads of patients at high risk of death in the next year and~     their surrogates from 30 dialysis clinics in 4 states. Patients and surrogates will complete~     questionnaires at baseline and after the intervention; all participants will be followed for~     up to 9 months.~   "
32736|NCT03138551|"~     This study will examine the feasibility and preliminary effects of the Mealtime PREP~     (Promoting Routines of Exploration and Play) intervention package for young children with~     Sensory Food Aversions and their parents.~   "
32737|NCT03138538|"~     The purpose of this study is to determine the maximum tolerated dose (MTD), safety,~     tolerability, Pharmacokinetic and antitumor activity of M8891 as single agent in subjects~     with solid tumors.~   "
32738|NCT03138525|"~     The purpose of this study is to assess effects of B cell depletion on the immune system in~     patients with relapsing forms of multiple sclerosis (MS) treated with ocrelizumab. This will~     be done by collecting blood from patients starting treatment with ocrelizumab before the~     first infusion and before the infusions at 6 and 12 months. The effects on the immune system~     will be assessed by performing transcriptome profiling of immune cells, measuring serum~     levels of microRNAs, and analyzing serum autoantibody immune signatures using antigen arrays.~     In addition, blood will be collected once from a group of healthy individuals to serve as~     controls.~   "
32739|NCT03138512|"~     The purpose of this study is to determine whether the combination of nivolumab and ipilimumab~     is safe and effective for delaying or preventing recurrence of cancer in patients who have~     experienced the partial or entire removal of a kidney~   "
32740|NCT03138499|"~     The purpose of this study is to determine whether an investigational immuno-therapy~     combination, nivolumab with Brentuximab vedotin compared to Brentuximab vedotin alone is safe~     and effective in the treatment of relapsed and refractory Classical Hodgkin Lymphoma. The~     participants of this trial will comprise of patients who have relapsed or did not respond to~     treatment and are not eligible for stem cell transplant~   "
32741|NCT03138473|"~     The investigators want to assess the use of the residual SYNTAX score and the SYNTAX~     Revascularization Index as predictors for in-hospital outcomes and mid-term (6 months to 1~     year) outcomes in patients with multi-vessel disease (MVD) who undergo PCI in the setting of~     STEMI or NSTEACS. Both values will be calculated in a number of patients over one year, and~     the relationship between both values and patient outcomes will be evaluated.~   "
32743|NCT03138447|"~     The digital health tool is an application (app) available on iOS and Android enabled mobile~     phones. Health Care Providers (HCPs) configure algorithms which can be tailored to~     individual patient's needs and then prescribe the app to support optimal basal insulin~     titration and dosing. In this study, participants will be recruited from a medical practice~     in which an HCP has prescribed a once-daily basal insulin. Participants will be trained on~     the use of the app utilizing their own mobile phone. During training, a brief self-assessment~     survey will be administered. After 90 days of usage, a telephone survey will be conducted.~     The baseline A1C results and the end of study A1C results will be collected from the~     patients' routine clinical care records. Data from the retrospective control group will be~     collected from a chart review of the same practice.~   "
32744|NCT03138434|"~     This study aims to determine whether advanced MRI sequences can provide robust and clinically~     relevant information about abdominal aortic aneurysms (AAAs). The MRI sequences will study~     outcomes related to blood flow inside AAA, microvasculature of the AAA vessel wall and~     intraluminal thrombus inside AAA.~      Robustness of these MRI sequences will be determined with testing of feasibility and~     reproducibility. Clinical relevance will be assessed by studying the association between the~     primary outcomes and disease severity. Disease severity will be expressed by AAA diameter.~      It is our hypothesis that these parameters are significantly related to disease severity and~     may therefore be future markers of disease progression.~   "
32745|NCT03138421|"~     This study will determine the safety and tolerability of ABX-1431 in patients with central~     pain when added on to background pain therapy.~      During the course of this study, each participant will take a daily dose of 20 mg of ABX-1431~     or a matching placebo for approximately 7 to 9 weeks.~   "
32746|NCT03138408|"~     This is a multicenter, first-in-human study of SC-004 in participants with advanced solid~     cancers. This is a two-part study consisting of Part A (dose regimen finding) followed by~     Part B (dose expansion). Part A will involve dose escalation to define the maximum tolerated~     dose (MTD) and/or recommended Phase 2 dose (RP2D) and schedule. Part B will enroll additional~     participants who will be treated with a study drug dose at or below the MTD determined in~     Part A.~   "
32747|NCT03138395|"~     This study will use droplet digital PCR (ddPCR) method to quantify and track peripheral blood~     plasma mutant allele frequency (MAF) in MDS and AML patients before, during and after~     chemotherapy treatment. Quantification of MAF from fingersticks and saliva samples will also~     be performed to determine feasibility of obtaining adequate circulating tumor DNA (ctDNA) for~     ddPCR.~   "
32748|NCT03138382|"~     There is an ongoing and worsening problem with obesity in the developed, and much of the~     developing world. Although it has long been realized that Western diets that are rich in~     sugar and fat play an important role in this, it has only recently been realized that~     exposure to these diets, particularly in childhood, can damage the part of the brain that~     determines how much fat there is in the body. The result of this damage is that the so-called~     set-point for fat in this part of the brain is pushed upwards. There is a lot of evidence~     from animals that activating the brain's balance (vestibular) system pushes this set-point~     for fat downwards to cause fat loss, probably because this tricks the brain into thinking~     that there is increased physical activity. The aim of this study is to see whether~     non-invasive electrical stimulation of the vestibular system in human participants causes a~     change in metabolism of fat and/or energy expenditure, which, if regulated upwards, would~     suggest this could be used as a means of reducing body fat in humans.~   "
32749|NCT03138369|"~     There is an ongoing and worsening problem with obesity in the developed, and much of the~     developing world. Although it has long been realized that Western diets that are rich in~     sugar and fat play an important role in this, it has only recently been realized that~     exposure to these diets, particularly in childhood, can damage the part of the brain that~     determines how much fat there is in the body. The result of this damage is that the so-called~     set-point for fat in this part of the brain is pushed upwards. There is a lot of evidence~     from animals that activating the brain's balance (vestibular) system pushes this set-point~     for fat downwards to cause fat loss, probably because this tricks the brain into thinking~     that the animal is more physically active. The aim of this study is to see whether the same~     effect can be triggered in humans by non-invasively stimulating the vestibular system with a~     small electrical current through the skin behind their ears.~   "
32750|NCT03138356|"~     In this integrated, Phase I study, the safety, tolerability, food effect, and pharmacokinetic~     (PK) properties of Fixed-Dose Combination Tablets of Saxagliptin / Dapagliflozin / Metformin~     XR and Dapagliflozin / Metformin XR Relative to Individual Components in Healthy Subjects~     will be investigated.~   "
32751|NCT03138330|"~     The purpose of this study is to collect nutritional information from young children aged~     15-36 months to validate a newly developed food frequency questionnaire.~   "
32752|NCT03138317|"~     Study was designed to evaluate efficacy of autologous platelet rich plasma (PRP) injections~     guided by ultrasound for treatment of knee osteoarthritis.~   "
32753|NCT03138304|"~     The objective of this study is to measure the duration of two different types of~     interventions to change physician decision making in trauma triage: a video game and an~     educational program.~   "
32754|NCT03138291|"~     Issue: The prevalence and severity of sleep-disordered breathing increases during pregnancy~     due to weight gain, physiological and hormonal changes. These sleep breathing disorders have~     a negative impact on perinatal health for both the mother and the child.The optimal treatment~     of obstructive sleep apnea in pregnancy is unknown. Although CPAP therapy is often the~     treatment of choice, the mandibular advancement appliance would be an interesting alternative~     to solve the matter.~      Objectives: The main objective of this pilot study is to evaluate the feasibility of~     mandibular advancement device to treat sleep apnea during the 2nd and 3rd trimesters of~     pregnancy. Secondary objectives will be tools to plan a future randomized controlled trial to~     determine the efficacy of this treatment.~   "
32763|NCT03138174|"~     Clinical System Accuracy Evaluation of the CE Marked One Touch Verio Flex blood glucose~     monitoring device as per requirements stated in ISO 15197:2015. To meet the requirements,~     glucose samples must be distributed over the operating range of the blood glucose monitor as~     stipulated in ISO:15197~   "
33108|NCT03133676|"~     This study will evaluate the safety and tolerability of KA34 when administered via~     intra-articular injection to subjects with osteoarthritis of the knee.~   "
32755|NCT03138278|"~     It is known from extensive documentation that second victims in critical illness often are~     the care givers of the patients: family, friends or other persons. Although this has not been~     specifically studied in the very old patients, there is no reason to believe that this group~     will be different from other ICU patients. Even more so, in this very old age patient group~     there are seldom any older relatives. Partners, like wife/husband or other cohabitants, may~     be dead or themselves incapacitated. Many will be in institutional care. The closest~     care-givers will be middle-aged people such as children or others, if no partners are~     available.~      The hypothesis is that critical illness can be a large stressor to care-givers of survivors~     in the VIP measured as the occurrence and severity of the usual problems like PTSD and~     depression. The investigators hypothesize that a low-threshold on-line support program~     decreases the magnitude of anxiety, depression and PTSD for care-givers of very old intensive~     care patients (VIP) after discharge.~   "
32756|NCT03138265|"~     This pilot study aims to investigate whether high intensity interval training can result in~     rapid improvements in physical fitness amongst the frail elderly (over 70 years old).~     Participants will undergo a wide range of physical fitness measures followed by a four week~     exercise protocol. Determination of improvement will be by repeated testing of the physical~     measures taken for baseline. The primary outcome measure will be anaerobic threshold. There~     will also be a subgroup of participants who will undergo muscle biopsy and D2O ingestion to~     allow an insight into the mechanistic basis behind exercise training response in this age~     group.~   "
32757|NCT03138252|"~     Study Purpose: The purpose of this study is to determine the optimal method for induction of~     labor in multiparous women who present with an unfavorable cervix.~      Hypothesis: Our hypothesis is that using oxytocin while the cervical ripening balloon is in~     place will result in more rapid labor courses, without increasing morbidity or increasing the~     need for operative delivery.~   "
32758|NCT03138239|"~     Hepatocellular carcinoma (HCC) is the fifth most common cancer and the second leading cause~     of cancer-related deaths in the world. Hepatitis C virus (HCV) is the most common underlying~     cause of cirrhosis and HCC in the western world.~      The staging of the disease is done by combining blood tests and imaging tests. Ultrasound~     scanning, computed tomograph (CT) and magnetic resonance imaging (MRI) scans are methods~     based on identifying or significant change in the liver.~      Those changes are sometimes difficult to identify, especially when there are changes in liver~     structure resulting from disease, such as cirrhosis of the liver.~      In many cases it is also difficult to detect secondary scattering in anatomical tests, such~     as identifying a disease in normal size lymph nodes or early skeletal dissociation.~      Functional imaging is not based on structural changes, but on the ability to detect changes~     in the function and properties of the tissue, such as a change in the cell's metabolic~     consumption or the presence of proteins that characterize the tumor tissue.PET scans can show~     tumor cell activity (the cancer cells are more aggressive, get more sugar and therefore see~     more absorption in PET), detect small tumors and metastases outside the liver (because they~     do a whole body test). To complete this test, a CT scan is also performed on the same device~     (PET-CT scanner).~      There is a new material called prostate-specific mRNA that is marked with gallium isotope~     (Ga-68-PSMA). It is the substance that is absorbed into the cells of the blood vessels of the~     tumor. The Ga-68-PSMA is now widely used in the diagnosis of prostate cancer. The new~     researches also found the possibility of using Ga-68-PSMA in primary liver cancer in patients~     because of the over-expression of the antigen in the blood vessels.~      Therefore, the tests with Ga-68-PSMA and F-18-FDG will complement each other and will give a~     complete picture of the extent of the disease.~      Each patient has individual characteristics of the tumor, and according to the results it~     will be possible to adapt the test to the patient with the appropriate material for the~     disease and this will be effective for the decision to treat and follow up.~      At the end of the study it will be possible to offer the study participant the appropriate~     functional imaging test.~   "
32759|NCT03138226|"~     Living donor uterus transplantation between identical twins, with IVF before and ET several~     months after transplantation. The donor should have completed childbirth.~   "
32760|NCT03138213|"~     Introduction: Pancreatoduodenectomy is one of the most complex abdominal operations, usually~     performed for tumors of the periampullary region and chronic pancreatitis. Minimally invasive~     surgery has been progressively developed, first with the advent of hybrid-laparoscopy and~     recently with the total-laparoscopy surgeries, but a number of issues are currently being~     debated, including the comparisons between three dimension laparoscopic~     pancreaticoduodenectomy and the open pancreaticoduodenectomy, the real advantages of three~     dimension vision systems, the reproducibility of a total intracorporeal technique and the~     oncological results achievable during long-term follow-up after pancreaticoduodenectomy.~      Methods/design: This is a prospective, randomized, controlled multicenter trial with two~     treatment arms, three dimension laparoscopic pancreaticoduodenectomy versus open~     pancreaticoduodenectomy. The trial hypothesis is that three dimension laparoscopic~     pancreaticoduodenectomy has advantages in postoperative recoveries and be equivalent in~     operation time, oncological results and long-term follow-up compared with open~     pancreaticoduodenectomy. The duration of the entire trial is two years including~     prearrangement, follow-up and analyses.~      Discussion: Despite the fact more and more studies comparing laparoscopic~     pancreaticoduodenectomy and open approach. This trial will be the first multi-center RCT~     comparing three dimension laparoscopic pancreaticoduodenectomy and open~     pancreaticoduodenectomy.~   "
32761|NCT03138200|"~     Transfusion of red blood cells is an everyday practice in critical care with the primary aim~     of restoring adequate tissue oxygenation. However, blood transfusion may also be harmful and~     costly, therefore a so called restrictive transfusion regime has been suggested by recent~     guidelines. These transfusion guidelines consider certain levels of hemoglobin as transfusion~     trigger, which on its own gives little information if any about the balance between oxygen~     delivery (DO2) and consumption (VO2). Hence, there is a clear need for additional physiologic~     transfusion trigger values. One of the potentially useful and easily obtainable physiological~     parameters is the central venous oxygen saturation (ScvO2), which has been shown to be a~     potential transfusion trigger value in hemodynamically stable but anemic patients. However,~     the role of ScvO2 as a transfusion trigger value was examined only in a retrospective~     observational study and in animal experiment.~      The normal value of ScvO2 in a resting adult at rest is around 70-75%, which is the product~     of the VO2 and DO2 relationship. Low ScvO2 usually indicates inadequate DO2. It was found in~     an observational study that if ScvO2>70% before transfusion due to transfusion only the value~     of hemoglobin increased but the value of ScvO2 did not change. This finding indicates that~     the DO2 may have been adequate in spite of the low hemoglobin value and the transfusion may~     have been unnecessary. In one of their recent animal experiments, the investigators reported~     that in an isovolemic-anemia model the value of ScvO2<70% was only reached when the value of~     hemoglobin was far less, 59 g/L, than the recommended lowest value of 70g/L as transfusion~     trigger by guidelines.~      Despite the pathophysiological rationale and the encouraging results of retrospective studies~     and animal experiments, prospective randomized trials in order to test the effects of an~     ScvO2-assisted transfusion protocol are yet to be performed.~      The aim of this study is to investigate the effects of an ScvO2-assisted transfusion protocol~     as compared to the guideline-based, hemoglobin levels guided transfusion practice.~   "
32762|NCT03138187|"~     This study is a randomized controlled trial, designed to evaluate the effect of structured~     physical exercise sessions on the spontaneous physical activity energy expenditure and~     caloric intake in overweight adults. The design employs a parallel three-group experimental~     arms: (1) a moderate exercise group (MEG); (2) a vigorous exercise group (VEG); and a control~     group (CG) without physical exercise sessions.~   "
32765|NCT03138148|"~     The synchronization between the patient and the ventilator is an essential objective during~     mechanical ventilation (MV). Maintaining the patient's respiratory activity during MV reduces~     ventilation pressures, improves oxygenation, and decreases sedation. In order to do this, the~     inspiratory or expiratory effort of the patient must be detected by the respirator' sensor~     systems, so that the assistance delivered by the respirator is coordinated with the patient's~     respiratory cycles. The usual systems do not actually detect the beginning of the effort but~     its result: variation in flow rate or pressure at the respirator circuit, which depends on~     the patient's respiratory mechanics and sensitivity of the sensor. This detection is~     currently imperfect, which generates asynchrony between the patient's needs and the~     assistance of the respirator. The asynchrony comprises the periods of delay between the~     beginning of the inspiration (or expiration) and the response of the respirator, but also of~     the unsuitable cycles: inspiratory efforts of the patient not detected by the respirator, or~     inversely triggering assistance in the absence of inspiration by the patient~     (self-initiation), or delivery of 2 cycles of assistance for a single inspiration (double~     triggering).~      Asynchrony is a risk factor for prolonged mechanical ventilation in adults. Adult studies~     have shown that patient-ventilator asynchrony is common during MV, and is associated with~     prolonged MV duration. An association with length of stay in intensive care and in hospital~     was also observed. In children, patient-ventilator synchronization is more difficult to~     achieve than in adults due to a higher respiratory rate and smaller current volumes. The~     impact of patient-ventilator asynchrony on evolution has not been studied in pediatrics.~      Patient-ventilator synchronization could be improved by the development of new ventilatory~     modes. The new NAVA (neurally adjusted ventilatory assist) ventilation mode detects the~     patient's breathing efforts earlier by monitoring the electrical activity of the diaphragm~     through the esophagus. This new mode seems to improve synchronization in children. NAVA~     ventilation may therefore be a step forward, but its clinical benefits remain to be seen.~      The objective of this study is to evaluate the impact of patient-ventilator asynchrony on the~     duration of mechanical ventilation in children with acute respiratory failure.~   "
32766|NCT03138135|"~     Home HIV self-testing has been FDA approved and allows users to read their own HIV test~     results at home, while home sexually transmitted infection (STI) test self-collection allows~     men to use a swab at home and mail it in for testing. The purpose of this study is to learn~     how Men who have Sex with Men (MSM) use these new testing options, a set of online support~     tools, and the option to test with someone to support them (a testing buddy).~      We will also evaluate whether the online tools help these men to connect with HIV prevention~     services such as Pre-Exposure Prophylaxis (PrEP) if they test HIV negative, and to HIV care~     services if they test HIV positive.~   "
32767|NCT03138122|"~     A random sample a random sample of half of all men born in 1943 and living in the city of~     Gothenburg, Sweden, have been investigated in 1993 at 50 years of age and will be followed~     continuously with repeated re-examinations and follow-up concerning mortality and~     cardiovascular diseased. Out of 1463 invited men, 798 (54.5%) accepted the invitation and is~     included in this longitudinal cohort study.~   "
32768|NCT03138109|"~     This retrospective cohort study was intended to analyze the incidence and risk factors of~     perioperative severe cardiovascular events in patients with diastolic dysfunction.~   "
32769|NCT03138096|"~     In the underlying study, a genetically modified P. berghei parasite is used. P. berghei is~     one of the four Plasmodium species that causes malaria in rodents. The hypothesis is that~     immunization of humans with P. berghei will induce a cross-species immune response without~     the risk of a breakthrough infection. To further increase the potential for protective~     efficacy, the P. falciparum circumsporozoite (CS)- protein gene has been integrated in the P.~     berghei parasite, generating a genetically modified P. berghei parasite, abbreviated as~     Pb(PfCS@UIS4).~   "
32770|NCT03138083|"~     This is a modular, first time in patient, open-label, multicentre study of OMO-1,~     administered orally, alone and in combination with anti-cancer treatments, in patients with~     locally advanced, unresectable or metastatic solid malignancies.~   "
32771|NCT03138070|"~     Single centre, single arm, preoperative window of opportunity study with a biomarker endpoint~     (expression profiling by RNA sequencing). Patients with resectable, histologically confirmed~     head and neck squamous cell carcinoma (HNSCC) for whom surgical treatment is planned as~     definitive management will be eligible.~   "
32772|NCT03138057|"~     This is a prospective, pilot study to explore the relationship between an infant's nutrition,~     skin and stool composition at different ages.~   "
32773|NCT03138044|"~     Assessment of the long-term outcome of combined ipsilateral liver lobe devascularization~     (ILAD) and alcohol injection of the large hepatocellular carcinoma (HCC): single center~     non-randomized trial.~   "
32774|NCT03138031|"~     Assessment of the long-term outcome of percutaneous ethanol alcohol injection (PEI) for the~     large and unresectable hepatocellular carcinoma: single center non-randomized trial.~   "
32775|NCT03138018|"~     Because of the lengthening of life expectancy, more and more people are concerned with the~     effects of aging on their mental faculties (e.g., memory decline) and with the possibility of~     getting Alzheimer's Disease (AD) or other forms of dementia. This increasing awareness of AD~     has already resulted in a growing demand for neuropsychological testing. AD's research also~     emphasizes the need for early screening to improve the prediction of the disease progression~     and the efficacy of any future therapy. Such a drive to screen for pre-dementia raises the~     challenging issue of frontline identification of individuals in the preclinical or early~     clinical stages of AD. Mild Cognitive Impairment (MCI) is typically considered to be the~     prodromal state of AD, and is therefore at the core of the drive for early screening.~     Moreover, Pre-MCI so called SCI (Subjective Cognitive Impairment) can precede AD for 15~     years. However, many individuals diagnosed with MCI do not convert to AD, some remaining~     stable and others even reversing back to normal (with rates of reversion to normal varying~     from 4.5% to as high as 53%). This over-diagnosis bias, which has been largely overlooked, is~     at the core of the present project at the interface of human and life sciences. Here, we~     argue that an important source of overdiagnosis in the prodromal state of AD comes from~     negative aging stereotypes (e.g., the culturally shared beliefs that aging inescapably causes~     severe cognitive decline and diseases such as AD) that permeate neuropsychological screening.~     There is ample evidence in the laboratory that such stereotypes contribute to the differences~     observed in the healthy population between younger and older adults in explicit memory tasks.~     Additionally, three pilot (lab) studies specifically conducted for the present ANR project~     showed that the threat of being judged stereotypically undermines the controlled use of~     memory of healthy older adults and simultaneously intensifies their automatic response~     tendencies, resulting in impaired memory performance. The present proposal goes several steps~     further by examining for the first time whether aging stereotypes are powerful enough to~     implicitly permeate the clinical neuropsychological testing and thus inflate memory deficits~     in older adults judged at risk (based on either epidemiological criteria or memory~     complaints), resulting in false-positive detection of SCI and MCI. This provocative~     hypothesis will be tested while 1) using biomarkers of neurodegeneration to distinguish~     false-positives from true MCI, and 2) using biomarkers of stress to examine whether and how~     aging stereotypes can lead to acute physiological stress during neuropsychological testing.~     This innovative project has the potential to offer new recommendations to improve the~     diagnosis accuracy of prodromal state of AD, with positive consequences for older people's~     wellbeing.~   "
32776|NCT03138005|"~     The Reduction of oxygen after cardiac arrest (EXACT) is a multi-centre, randomised,~     controlled trial (RCT) to determine whether reducing oxygen administration to target an~     oxygen saturation of 90-94%, compared to 98-100%, as soon as possible following successful~     resuscitation from OHCA improves outcome at hospital discharge.~   "
32777|NCT03137992|"~     The purpose of this study is to show bioequivalence of test product to reference product~     based on baseline-adjusted forced expiratory volume in one second (FEV1).~   "
32778|NCT03137979|"~     This study is to evaluate the safety and efficacy of Gingiva Mesenchymal Stem Cell Therapy~     for Chronic Adult Periodontitis.~   "
32779|NCT03137966|"~     Diabetic foot ulcer (DFU) is one of the most invalidating complication of diabetes and~     represents a big economic burden for the society. No specific therapy is available for~     diabetic foot ulcers.The aim of this study is to define a new approach for treatment of~     chronic diabetic wounds. Our concept is based on the improvement of the cellular reaction to~     hypoxia. It will address the transcriptional factor HIF-1 (Hypoxia inducible factor-1) which~     is the cellular sensor for oxygen and which is specifically repressed by hyperglycemia. The~     study will investigate the effect of local deferoxamine (0.66 mg/ml), the only known HIF-1~     inducer, on the wound healing rate in patients with neuropathic diabetic foot ulcers. The~     primary objective of the study will be the reduction with >50% of the wound area after 12~     weeks of treatment.~   "
32780|NCT03137953|"~     In gingivobuccal complex tumors, the skin margin is assessed by palpation (skin pinch test).~     There is no objective method of assessment of skin margin. This study is to evaluate the role~     of computed tomography/MRI with contrast in assessing the deep surgical margin.~   "
32781|NCT03137940|"~     The study aims to evaluate the safety and the feasibility of transcranial Direct Current~     Stimulation (tDCS) session in children and young adults with Unilateral Cerebral Palsy (UCP).~     Secondarily it aims to test the effects of tDCS (real vs sham) in improving, in very short~     term, Upper Limb (UL) functions.~   "
32782|NCT03137927|"~     The study contains three periods: screening, inpatient hospitalization and follow-up. And~     should be leaded as a randomized placebo-controlled study with in chain order enrolled~     volunteers and dose escalating.~   "
32783|NCT03137914|"~     This clinical study has as main objective to evaluate if the Nasal Septum Autologous~     Chondrocytes Transplantation for Condylar Resorption is safe and effective in the treatment~     of degenerative lesions of temporomandibular joint (TMJ). It is a case series, in which 10~     participants with diagnosis of condylar reabsorption of TMJ will be selected, with~     orthognathic surgery indicated. Orthognathic surgery is conventionally indicated for patients~     with condylar resorption to correct dentofacial deformity and, therefore, will not be~     performed only in function of this clinical study. The selected participants will be~     submitted to nasal cartilage biopsy, for isolation and preparation of the chondrocytes. The~     only experimental group to be evaluated will be the group treated with autologous~     chondrocytes diluted in hyaluronic acid. The experimental treatment will be performed 15 days~     after orthognathic surgery, and will be injected through arthrocentesis. Clinical follow- up~     will be performed in the following periods: 7 and 15 days and 1, 3, 6 and 12 months after~     treatment. During the consultations, participants will also be evaluated for the intensity~     and severity of the pain experienced, as well as the disability related to it, through the~     same system used for the diagnostic classification (RDC / TMD). Imaging of the TMJ will be~     performed before, 6 and 12 months after the injection of the experimental treatment for bone~     and cartilaginous joint tissue analysis. Autologous chondrocyte implantation is expected to~     promote the regeneration of TMJ cartilage tissue safely and effectively.~   "
32784|NCT03137901|"~     This study test the agreement and precision of Pulse Pressure Variation (PPV) and Cardiac~     Output (CO) obtained by the Android application Capstesia™ against another pulse contour CO~     monitoring ( EV-1000, Edwards Lefesciences, USA)~   "
32785|NCT03137888|"~     This pilot clinical trial studies the side effects of spectroscopic magnetic resonance~     imaging (MRI)-guided radiation therapy and how well it works in treating patients with~     newly-diagnosed glioblastoma or gliosarcoma. Spectroscopic MRI can show doctors where the~     extent of tumor is in the brain beyond current clinical MRI scans by mapping areas of high~     tumor metabolism. Radiation therapy uses high energy beams to kill tumor cells and shrink~     tumors. Spectroscopic MRI-guided radiation therapy may work better in treating patients with~     glioblastoma or gliosarcoma.~   "
32786|NCT03137875|"~     Specimen transport from peripheral health structures to the National TB reference laboratory~     for MDR-TB identification presents a big challenge in term of sample management, safety,~     contamination and delays. Thus a system that allows specimen to be collected and shipped in a~     safely manner while reducing the possibilities of contamination, the cost of shipment and~     especially the time for detection of MDR-TB by using molecular methods would be very useful.~     Whereas the some studies show promising results for the development and standardization of~     simple specimen collection and transportation methods for molecular DST, more data is needed~     before these can be used in routine.~      The study described here aims at identifying a suitable method, in terms of adapted sample~     support (s) (slide, filter paper (FTA, Genocard ...)) and DNA extraction method. If one or~     several methods are found to give satisfying results, then a larger patient based evaluation~     of this (these) method(s) for molecular DST will be performed in a second phase. The protocol~     for the second phase will be prepared separately.~   "
32787|NCT03137862|"~     A PROSPECTIVE, double blind, placebo-controlled trial~   "
32788|NCT03137849|"~     Autonomic and endothelial imbalance in post menopause women raise the need to manage~     cardiovascular risk. Yoga poses and breathing control present controversial results on~     prevention and treatment of hypertension.. The aim of this study is to compare the effect of~     12 week intervention based on yoga poses and their muscle contractions known as bandhas~     (pelvic floor, core and throat/neck) and ujjayi pranayama (victorious breath) on autonomic~     modulation, endothelial function, arterial stiffness, aerobic capacity and cognitive function~     of hypertensive post-menopausal women.~   "
32789|NCT03137836|"~     In this trial the investigators aim to verify the potential impacts of a multi-level~     intervention with standing desks on behavior and cognitive function in children~   "
32790|NCT03137823|"~     Diagnosis of Group A beta hemolytic strep tonsillitis -~        -  cultre of tonsills (gold standard)~        -  culture from bucal surface (test)~   "
32791|NCT03137810|"~     The aim of this work is to compare the effectiveness of placental cord drainage with no~     drainage in reducing the duration and blood loss in 3rd stage of labour.~   "
32792|NCT03137797|"~     The purpose of this study is to evaluate the short, medium and long-term prognosis for newly~     diagnosed HIV patients.~   "
32793|NCT03137784|"~     The purpose of this trial is to characterize the bronchodilator effects and safety of 25 ug~     and 50 ug o.d. NVA237 (glycopyrronium bromide) doses compared to placebo in asthma patients~   "
46546|NCT02957630|"~     The proposed study will provide an assessment of the effect of this combination on endocrine~     function, metabolic control and hemostasis during 6 treatment cycles. This will be compared~     to the effects of two reference COCs.~   "
32794|NCT03137771|"~     This randomized phase II/III trial studies how well giving maintenance chemotherapy with or~     without stereotactic body radiation therapy works in treating patients with stage IV~     non-small cell lung cancer. Drugs used in maintenance chemotherapy, such as docetaxel,~     pemetrexed disodium, and gemcitabine work in different ways to stop the growth of tumor~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Stereotactic body radiation therapy is a specialized radiation therapy that sends~     x-rays directly to the tumor using smaller doses over several days and may cause less damage~     to normal tissue. Giving maintenance chemotherapy and stereotactic body radiation therapy~     together may work better than maintenance chemotherapy alone in treating patients with stage~     IV non-small cell lung cancer.~   "
32795|NCT03137758|"~     This is an open label, non-randomized, Phase I, dose escalation/dose expansion study of~     PCUR-101 in combination with androgen suppression therapy in the patients with metastatic~     CRPC~   "
32796|NCT03137745|"~     To study the changes in coagulation profile in patients undergoing cytoreductive surgery and~     Hyperthermic intraperitoneal chemotherapy. The objective of the study is to determine the~     utility of thromboelastography in comparison to standard coagulation tests in assessing the~     coagulopathy in patients undergoing CRS with HIPEC.~   "
32797|NCT03137732|"~     This is a single centred randomized controlled trial comparing surgeon versus anaesthetist~     inserted rectus sheath catheters for management of analgesia post major abdominal surgery.~   "
32798|NCT03137719|"~     Hospitalized cirrhotic patients are at high risk of complications and adverse outcomes. This~     study aims to determine the current practice and outcomes in these following areas:~        1. Community-acquired infections~        2. Nosocomial infections~        3. Development of second infections~        4. Factors predicting ICU care, organ failure, death, and disability~        5. Patterns and adequacy of albumin use in infected and non-infected patients~        6. Per and post-liver transplant outcomes~        7. Quality-assurance and adequacy of management of complications of cirrhosis such as~          hepatic encephalopathy, variceal bleeding, hyponatremia, and hypernatremia~        8. Regional variations in outcomes and therapeutic strategies~   "
32799|NCT03137706|"~     This pilot research trial studies characterization of mechanical tissue properties in~     patients with pancreatic, liver, or colon cancer. Mechanical properties and stiffness of the~     cancerous tissue may be correlated with the standard pathology report that describes the~     stage of the disease.~   "
32800|NCT03137693|"~     This study involves a course of radiation to the tumor that is delivered BEFORE surgery. The~     type of radiation is called stereotactic ablative body radiation therapy (SABR). The purpose~     of this study is to evaluate the effects, good and/or bad, of pre-operative SABR specifically~     focusing on its ability to reduce the chances that additional breast surgery will be needed,~     reducing the amount of breast/heart/lung tissue that is irradiated, and to study the~     tumor-tissue effects of SABR. The usual treatment for patients with early-stage breast cancer~     who have breast-conserving treatment (BCT) is to receive radiotherapy AFTER surgery,~     targeting either the whole breast or part of the breast.~   "
32801|NCT03137680|"~     To investigate the effect of pre-operative exercise on~        1. Hemodynamics in the fistula artery and vein, pre and post AV fistula formation~        2. Suitability of cannulation of AV fistula at 8weeks~   "
32802|NCT03137667|"~     A cluster-randomized trial (clustering by school) was conducted in Monroe County, NY. Twenty~     middle and high schools were paired based on several characteristics and randomized within~     pairs to receiving a school-based influenza vaccination clinic or not (control).~   "
32803|NCT03137654|"~     This pilot project addresses two understudied questions related to neurocognitive deficits~     observed in treatment-seeking alcoholics. First, whether cognitive training improves~     performance and outcomes in alcoholics, and whether men and women differ in their response to~     this training. The second is whether directed training using affective materials (e.g.,~     emotional faces) is differentially effective compared to that using traditional (i.e.,~     neutral) stimuli.~   "
32804|NCT03137641|"~     CACIES is a descriptive study conducted in two hospital centers in France to assess nurses~     internal contamination by antineoplastic drugs.~   "
32805|NCT03137628|"~     As a newly developed subject, metabolomics can detect accurately and quantitatively small~     molecule metabolites such as proteins, carbohydrates and lipids from plasma, tissue and even~     single cell, which aims to analyze systemic dynamic change during physiological and~     pathological processes, and thus reveals certain reactions that whole organism responds to~     specific stimulation.~      Colorectal cancer is one of common gastrointestinal tumors, whose morbidity rate tends to~     increase in recent years for modern diet and life style, and colectomy serves as one standard~     treatment for it. Under total stimulation of surgical operation, general anesthesia and~     mechanical ventilation, a series of stress reactions happen complicatedly to colorectal~     patients during anesthesia-ventilation process. Without timely recognition and management of~     adverse reactions, side effects like hypoxemia, hemorrhage, inflammation, and even death will~     happen intraoperatively or postoperatively.~      With different metabolomics methods applied to collect, detect and analyze blood samples,~     metabolomics provides an innovatory approach to elucidate systemic response during~     anesthesia-colectomy process with multi-factors included. By analyzing and comparing dramatic~     alteration of small molecule metabolites in colorectal cancer patients' or healthy controls'~     plasma in this project, data can reflect the influence of certain disease (colorectal~     cancer), anesthetics and mechanical ventilation on colorectal patients with colectomy, which~     is helpful for prevention and treatment of intraoperative and postoperative complications.~   "
32806|NCT03137615|"~     The purpose of this study is to determine the effects on the heart of injecting local~     anaesthetic into the nose prior to surgery on the pituitary gland?~   "
32807|NCT03137602|"~     Taking part in recommended levels of physical activity in youth with MS may have an important~     and positive impact on disease symptoms, long-term disability and health outcomes.~     Unfortunately, youth with MS are highly inactive. In order to address this issue, the~     investigators have developed an MS-specific mobile application for teens called Active Teens~     with Multiple Sclerosis (ATOMIC). In this research the investigators will evaluate the~     feasibility of using the ATOMIC program in youth with MS. The results of this pilot study~     will provide the data necessary to ensure the ATOMIC program aligns with the needs of youth~     with MS.~   "
32808|NCT03137589|"~     Telemedicine allows providing expert know-ledge from specialized health centers to regional~     hospitals and practices. In this multicenter, prospective, non-interventional study hospitals~     and practices in NRW are supplied via a telematics platform with expertise from the~     university hospitals RWTH Aachen and Münster. The communication occurs via highly encrypted~     audio/video conference systems and a certified data exchange platform Fallakte+. In total~     40.000 outpatient and stationary patients with infectious diseases or need for intensive care~     should be treated with telemedical support. The participating hospitals and practices are~     randomly distributed into four clusters. The clusters are supplied with telemedicine at~     different time points but all clusters start at the same time collecting data from patient~     cohorts of infectiology and intensive care (e.g. symptom, therapeutic progress and outcome).~     The collected data is later compared to data obtained in the same way from patients treated~     with telemedical support and evaluated regarding differences in the quality of treatment,~     therapeutic process and the satisfaction of the patients with telemedicine. The aim is to~     improve the treatment quality in regional hospitals and practices of patients with serious~     and complex diseases and bring forward the application of telemedicine.~   "
32809|NCT03137576|"~     A randomized prospective trial to test the non-inferiority of Erector Spinae Plane Block~     (ESPB) in comparison with paravertebral block during non-intubated thoracoscopic lung~     resection~   "
32810|NCT03137563|"~     This trial aimed at evaluating the acceptability of HPV self-sampling among french women~     eligible for cervical cancer screening (25 - 65 years old) in the region of Occitanie, in the~     south of France. Acceptability will be evaluated using an anonymous questionnaire and the~     main outcome of the study will be the response acceptability  yes  or  no  for HPV~     self-sampling. Secondary outcome will be analysis of socioeconomic determinants for the~     acceptability of HPV self-sampling.~      These data will help to propose new strategies for cervical cancer screening in France,~     particularly to taget non-attenting populations~   "
32811|NCT03137550|"~     Main aim of the COMBAT-CAD-Study is to clarify, if the combination of stress testing with~     biomarkers improves the diagnostic accuracy.~      Hypothesis of our study is that diagnosis of CAD can be improved by adding biomarkers to~     solely stress testing for the workup of patients with suspected CAD or progress of already~     known CAD.~   "
32812|NCT03137537|"~     This study will explore whether ivabradine lowers heart rate, and thus improves exercise~     capacity, in survivors of lymphoma who have an elevated resting heart rate as a side effect~     of prior radiation treatment.~      The drugs involved in this study are:~        -  Ivabradine~        -  Placebo~   "
32813|NCT03137524|"~     Chronic Obstructive Pulmonary Disease (COPD) is a common smoking related lung disease. The~     main symptom in breathlessness.~      Pulmonary Rehabilitation (PR) - a supervised group exercise and education class - is an~     effective intervention in COPD to reduce symptoms, improve exercise performance and prevent~     exacerbations. However some COPD patients are unable to to effectively exercise as they are~     limited by their breathlessness, despite optimal medical management. By reducing their~     physical activity to avoid the onset of breathlessness, they become deconditioned and then~     further attempts at exercise make them more breathless, leading to an inactivity cycle.~      There is a growing evidence base regarding the use of hand hold fan therapy or air therapy to~     relieve breathlessness at rest. Limited studies have looked at the use of fan therapy during~     exercise, and its role on exercise capacity and recovery time, provisional results which~     indicate it may also be useful during activity. Logically you might expect patients who are~     less breathless to be able to exercise more, or recover quicker.~      This study aims to investigate the effects a hand held fan will have on sensation of~     breathlessness and exercise capacity in patients with COPD. This will involve participants~     undertaking a standardised field walking test ( 6 minute walk test) with and with out the fan~     and then comparing the distance covered and how they felt during and after exercise. This~     will better inform how we structure exercise and advice to these patients in the future to~     empower patients limited by breathlessness.~   "
32814|NCT03137511|"~     Early detection of melanoma showed an impact on the thickness of the lesions at the time of~     diagnosis. One challenge is to improve the modalities.~      Decrease the rate of non-compliant patients among patients referred to the dermatologist for~     a suspicious lesion (patients who will never go to the consultation), and reduce the time~     interval between the first identification of the lesion and the excision allowing the~     diagnosis are major issues.~      Direct contact between the general practitioner (GP) and the dermatologist would probably~     make it possible to shorten the care pathway of patients with lesions justifying excision.~      The objective is to evaluate whether contacting the dermatologist directly by telephone and~     e-mailing the photograph of a suspicious melanoma lesion can significantly reduce the time~     required for access to the consultation for the following patients: (a) referred for a~     suspicious lesion of melanoma by the GP (b) and having a sufficiently suspicious lesion of~     melanoma so that the dermatologist conclude at the need for excision (true positives).~      Expected results: The procedure should shorten the care pathway for patients with melanoma~     and decrease the proportion of patients who do not consult the dermatologist when they were~     referred (non-observing patients).~      This should facilitate the identification of thinner lesions. The benefit for the patient is~     then direct with a survival at 5 years higher.~      In public health terms, it is expected a benefit as better optimization of resources. In a~     situation of shortage of professionals, access to the dermatologist should be optimized by~     optimizing emergency access for patients who require it.~   "
32815|NCT03137498|"~     The hypothesis of the study is that lidocaine will be as effective as ketorolac in decreasing~     patient's perception of pain as measured by the 10 point Visual Analogue Scale (VAS). The aim~     of the study is to compare the safety & efficacy of lidocaine versus ketorolac for acute pain~     secondary to renal colic in the Emergency Department (ED).~   "
32816|NCT03137485|"~     This study is aimed to compare between the results of conventional lumbar discectomy and the~     newly used technique in our department; endoscopic lumbar discectomy in neurosurgery~     department Assiut university hospitals, so that we can offer our patients the best service in~     an updated and minimally invasive way.~   "
32820|NCT03137433|"~     This study seeks to examine whether meal-replacement therapy is able to enhance weight loss~     among teens with severe obesity. In addition, we are also interested in examining the degree~     of weight loss needed to improve important cardiometabolic risk factors among adolescents.~   "
32821|NCT03137420|"~     Patients who have sustained and survived a polytrauma do heavily depend on the support and~     functioning of their family. This is only possible if the family members are physically and~     mentally able to cope with the situation.~      It is the investigators' hypothesis that the true percentage of polytrauma patients'~     relatives suffering under relevant psychological distress is higher than commonly assumed.~      The investigators conduct a prospective cohort study where we follow up on a cohort of~     patients and their relatives over 1 year after trauma - one group with severely injured~     patients (case) and one group with minor musculo-skeletal injuries (control).~      In order to assess the influence of the patients' disability and their own psychological~     distress on the psychological distress of the relatives, the investigators also collect~     corresponding data from the patients themselves.~      In order to assess the influence of the trauma itself, the investigators compare a group of~     multiple injured patients and their relatives with a group of patients with isolated~     musculoskeletal injuries and their relatives. In addition, the investigators record the ISS~     of each patient. In order to investigate the changes in relatives' distress over time and to~     find out more about potential risk factors or con-founders it is necessary to conduct a~     prospective study.~   "
32822|NCT03137407|"~     The specific aim of the study is to compare the safety and efficacy of a single~     administration of DaxibotulinumtoxinA for Injection versus placebo for managing plantar~     fasciitis.~   "
32823|NCT03137394|"~     This study will investigate the progression of musculoskeletal (shoulder muscle flexibility,~     muscle strength, movement coordination, and rotator cuff health) and psychosocial (fear of~     movement, pain catastrophizing) impairments for the first year following SCI, starting with~     inpatient rehabilitation, at 6 months, and at 1 year following SCI.~      We will use the information obtained from this study information to develop a biopsychosocial~     prospective surveillance model, a method for early detection, intervention, and moderation of~     shoulder pain. Specifically, we will identify sources of biopsychosocial shoulder pain to~     establish effective physical and cognitive-behavioral treatment to prevent loss of function~     and independence in individuals with SCI who depend on their arms for activities of daily~     living, transfers, and wheelchair propulsion.~   "
32824|NCT03137381|"~     This study will evaluate the safety and efficacy of CTP-543 in adult patients with chronic,~     moderate to severe alopecia areata.~   "
32825|NCT03137368|"~     This is a multicenter, randomized, open-label, parallel, active-controlled superiority~     clinical study conducted in early premenopausal estrogen-receptor positive breast cancer~     patients with CYP2D6*10 mutations. The efficacy and safety of Exemestane Tablets combined~     with ovarian function suppression/ablation and Tamoxifen Tablets combined with ovarian~     function suppression/ablation in the treatment of early premenopausal estrogen-receptor~     positive breast cancer patients with CYP2D6*10 mutations are compared.~   "
32826|NCT03137355|"~     The purpose of this study is to develop a database containing clinical and laboratory~     information for patients with Leigh syndrome. The goal is to provide a greater understanding~     of Leigh syndrome allowing further characterization of this disease.~   "
32827|NCT03137342|"~     Pepped on PrEP is an innovative pilot RCT designed by an interdisciplinary team to develop a~     counseling and problem-solving PrEP adherence intervention with a Behavioral Activation (BA)~     approach that aims to re-engage participants in safe but pleasurable activities in life and~     addresses stimulant-abuse as well as associated factors including depression, as barriers to~     optimal PrEP adherence.~   "
32828|NCT03137329|"~     The study aims are~        1. to demonstrate the feasibility of recruiting and enrolling 10 subjects aged 55-75~          planning to undergo sleeve gastrectomy and enrolling 10-20 (1-2 per surgical patient)~          matched subjects to the described intensive lifestyle intervention.~        2. to collect preliminary data on the comparative effectiveness of the two interventions on~          physical function, weight loss, body composition, bone density and QOL.~   "
32829|NCT03137316|"~     The aim of this study is to evaluate the prevalence of secondary hyperparathyroidism among~     patients with diabetic nephropathy.~   "
32830|NCT03137303|"~     The purpose of this study is to evaluate the use of spirometry in identifying Diagnostic~     Error in COPD and Asthma patients.~   "
32831|NCT03137290|"~     A reversal agent is commonly given to improve neuromuscular function after intra-operative~     administration of non-depolarizing neuromuscular blocking agents. The administration of~     conventional reversal agent neostigmine is associated with many undesirable side effects. For~     almost a decade, a new novel drug sugammadex has been used to specifically antagonize the~     effect of aminosteroidal neuromuscular blocking agents.~      A total of 80 paediatric patients planned for general anaesthesia were divided into two~     groups and were given either neostigmine+atropine, or sugammadex for reversal once the~     operation had completed.~   "
32832|NCT03137277|"~     Adenoma detection rate (ADR) is the most important parameter to measure outcome quality of~     (screening) colonoscopy. Since single improvements of imaging have not been able to improve~     ADR in many randomized studies, the present study tested the hypothesis that only multiple~     imaging improvements such as seen with two generation changes of colonoscopies - i.e.~     skipping one colonoscope generation - may be necessary before improvements in ADR can be~     measured.~      The investigators will test this hypothesis in the present randomized tandem study in 7~     private practices in Hamburg and Berlin, in a pure screening colonoscopy setting, aiming at~     inclusion of 1200 patients > age of 55 years (screening colonoscopy cut-off in Germany).~     Exclusion criteria are symptomatic patients and colonoscopies planned for therapeutic~     reasons. Main outcome parameter is the ADR (rate of patients with at least one adenoma/all~     patients).~   "
32833|NCT03137264|"~     The study is being done to determine if non-invasive testing (urine and plasma testing) is as~     effective as tissue testing in identifying epidermal growth factor receptor (EGFR) T790M~     mutation status. EGFR is a type of protein found on the surface of cells in the body. When~     this protein is mutated and becomes too active, it can lead to cancer growth. T790M is a~     mutation that develops in response to treatment of the EGFR mutation.~      Participating patients will have tumor tissue (via cobas test), as well as 2 plasma samples~     (via cobas and Guardant360 tests) and 1 urine sample (via Trovera test), tested for EGFR~     T790M mutation status. If the results of the cobas tissue and/or plasma test show that a~     patient is T790M positive, they will be treated according to standard of care, which may~     include treatment with osimertinib. Osimertinib is approved for use in the United States for~     the treatment of EGFR T790M mutation-positive non-small cell lung cancer (NSCLC).~   "
32834|NCT03137251|"~     This study evaluates the effectiveness of the Transcutaneus Electric Nerve Stimulation (TENS)~     during the labour. TENS is a low frequency electrotherapy technique, analgesic type,~     generally used in musculoskeletal pathology.~      The investigators will have three groups of participants to be administered the TENS, a~     different dose in two groups, while the third will correspond to placebo.~      The hypothesis of the study is to verify if the TENS is effective as a non-pharmacological~     method in the relief of pain during childbirth~   "
32835|NCT03137238|"~     Parkinson's Disease as well as being a disorder of motor function also causes a wide range of~     non-motor disturbances many of which are involved in the prodromal stage prior to the onset~     of motor symptoms. Abnormal perception in the visual and in other domains is increasingly~     being recognized. Control of the movement of our bodies in space involves perception of~     self-motion which is dependent on the processing and integration of multimodality information~     from the kinesthetic, proprioceptive, visual (mostly optic flow) and vestibular systems.~     Dysfunction in this process may contribute to disturbed postural control and thus result in~     gait abnormalities and falls which are common as Parkinson's disease progresses, is difficult~     to treat and causes disability and a loss of independence.~      The integration of information from different modalities (multisensory integration) is~     vital for intact perception of the world. Theoretical studies, based on Bayesian statistics,~     have provided a framework to study multisensory-integration with predictions for an 'optimal'~     strategy.~      Many human and animal studies have demonstrated near optimal cue-integration. Yet, while~     multisensory integration is an active topic of research in normal brain function, with~     well-established tools, it has not been studied in PD. The investigators hypothesize, based~     on the apparent over-dependence in PD on visual cues that PD patients will demonstrate~     defective multisensory integration. This can have profound effects on basic motor functions.~     Furthermore, based on both visual and vestibular abnormalities (described above) the basic~     (uni-sensory) performance may also be degraded in PD.~      In this study the investigators will observe the basic (uni-sensory) and the multisensory~     integration of visual and vestibular perception of self-motion within the same experiment.~   "
32836|NCT03137225|"~     The investigator hypothesizes that in very low birth weight infants who require respiratory~     support via noninvasive ventilation, that synchronizing the ventilator breath with the baby's~     breath using neurally adjusted ventilatory assist (NAVA) will reduce the number and/or~     severity of apnea/bradycardia/desaturation episodes compared to nasal intermittent positive~     pressure ventilation (NIPPV).~   "
32837|NCT03137212|"~     Patients with acute ST-segment elevation myocardial infarction and thrombolysis indications,~     will be given the recombinant human prourokinase for thrombolysis treatment, and in~     accordance with the guidelines, will be treated with coronary angiography examination 3 to 24~     hours after thrombolysis. The study will explore the best time for interventional therapy~     combined with thrombolysis.~   "
32838|NCT03137199|"~     A Phase 1 investigation will be performed to test the safety of two doses of bonemarrow~     derived MSCs (20,000,000 and 100,000,000) administered via peripheral intravenous infusion.~   "
32839|NCT03137186|"~     This study evaluate the addition of metformin to standard of care in locally advanced and~     metastatic prostate cancer, half the patient will receive metformin in combination with~     standard treatment, and the other half will receive the standard of care only~   "
32840|NCT03137173|"~     The purpose of this study is to compare the safety and efficacy of ceftobiprole medocaril~     versus vancomycin plus aztreonam in the treatment of patients with acute bacterial skin and~     skin structure infections.~   "
32841|NCT03137160|"~     An Open-Label, Proof-Of-Concept, Study of Ixekizumab in the Treatment of Pyoderma Gangrenosum~   "
32842|NCT03137147|"~     This study tests the feasibility, acceptability, and preliminary efficacy of a seven-session~     cognitive-behavioral therapy intervention to treat sleep and pain problems in youth ages~     11-17 with co-morbid headache and insomnia.~   "
32843|NCT03137134|"~     This study will estimate the effect of food and the proton pump inhibitor, esomeprazole on~     the pharmacokinetics of crizotinib in a coated microsphere formulation.~   "
32844|NCT03137121|"~     The purpose of this study is to evaluate the use of olanzapine for the treatment of cancer~     patients with chronic nausea and/or vomiting unrelated to chemotherapy or radiation in a~     randomized placebo-controlled pilot trial.~   "
32845|NCT03137108|"~     Recently, a transcutaneous protocol of electrical spinal cord stimulation (tSCS) has been~     developed. It was suggested, that this method could be used to improve the therapy process~     after a spinal cord injury (SCI). The aim of this study is to investigate the immediate~     effects of tSCS with different stimulation modalities on voluntary motor control in patients~     with incomplete SCI.~   "
32846|NCT03137095|"~     Study is enrolling newly diagnosed breast cancer patients about to start chemotherapy and~     age-matched control participants. The investigator is trying to better understand the~     prevalence of cognitive difficulties in cancer patients receiving chemotherapy compared to~     the general population as well as what biological mechanisms may play a role in the~     development of these difficulties. Patients will be asked to complete five assessments over~     the course of approximately 5 months. Assessments 1,3 and 5 include computerized and paper~     and pencil cognitive testing as well as blood draws. Assessments 2 and 4 only involve the~     collection of a blood sample.~   "
32847|NCT03137082|"~     Guanfacine may preferentially reduce craving and improve cognitive control in women with~     Alcohol Use Disorder (AUD), compared to men. As these behaviors are related to relapse, the~     objectives of this study are to conduct a 10-week out-patient clinical trial to examine the~     effects of Guanfacine Extended Release (XR; 3mgs) versus placebo on drinking measures in~     women with AUD.~   "
32848|NCT03137069|"~     The purpose this study is to evaluate the efficacy, safety, and pharmacokinetics of GDC-0853~     compared with placebo in participants with Chronic Spontaneous Urticaria (CSU) refractory to~     anti-histamines.~   "
32849|NCT03137056|"~     Hemodialysis is the major technique of renal suppleance and membrane improvements allow an~     efficient depuration. During the past fifty years, improving the architecture of the~     membranes increased constantly the clearance of uremic toxins. Online-hemodiafiltration~     allowed a potential interest for decreasing morbi-mortality, but this technique is not~     available in all hemodialysis centers yet. Theranova membrane, by its innovating~     architecture, could be a valuable option for the enhancement of toxin removal in patients who~     are not eligible for online-hemodiafiltration techniques. Interestingly, many works pointed~     adsorptive capacities of dialysis membranes and these observations suggest that adsorption~     cannot be considered as an epiphenomenon. However, there is a lack of knowledge about the~     extent of its benefits in hemodialysis. The efficiency of a session of hemodialysis is~     routinely based on the clearance of only few generic toxins (urea, ß2-microglobulin,~     myoglobin). The eKT/V formula permitted to link a good depuration of urea with a better~     survival. EuTox described in a recent review, a large panel of middle molecules considered as~     uremic toxins. As there are many involved toxins, modern evaluation of hemodialysis~     efficiency can't be still based on the only description of ß2-microglobulin and urea~     removals. Inflammation status is routinely measured with blood levels of CRP. However, its~     accumulation is not leading to a toxicity. Many others inflammatory markers have been linked~     with morbidity and atherosclerosis, the main cause of mortality in ESRD patients. Obviously,~     removal of inflammatory markers by different dialyzers needs to be assess concomitantly but~     single conventional dosages are time-consuming.~      A minimal albumin loss is considered as another important factor for a safe hemodialysis. Due~     to its multiple biological functions, albumin may be one of the most important protein for~     the maintenance of body homeostasis. Recent works were interested in the potential toxicity~     of some isoforms of the albumin and especially in chronic kidney disease. Modified forms of~     albumin have been linked with toxic properties and the removal of modified forms could be~     beneficial. Furthermore, albumin oxidation can lead to an under-estimation of albumin levels~     with the routinely used assay. A modern evaluation of the capacities of depuration of~     dialyzers clearly needs to integrate the evaluation of the clearance and generation of~     modified forms of albumin and proteins.~      Proteomic techniques allow an interesting non-selective integrative approach. This exhaustive~     view would be particularly adequate for building a snapshot of blood uremic toxins,~     permeative and adsorptive capacities of each membrane. Due to a high sensitiveness, proteomic~     techniques can improve dramatically the characterization of the depuration capacities of~     different hemodialysis membranes considering a large range of uremic toxins especially with~     middle molecular weight, a large panel of inflammatory markers and modified forms of albumin.~     Furthermore, proteomic approach can help to build a quasi-exhaustive description of all the~     proteins removed by a membrane.~      This project aims to compare the removal capacities of each membrane on a large range of~     proteins and forms of albumin (native and modified) with a highly-sensitive LC-MS/MS~     proteomic approach. We will also build the complete proteome of depuration of each tested~     membrane.~   "
32865|NCT03136848|"~     Kidney transplantation is the treatment of choice for end-stage kidney failure, but access to~     transplantation is limited by a severe shortage of donor organs. Although the use of kidneys~     from higher risk deceased donors has increased the availability of organs, these grafts are~     associated with a greater risk of delayed function, inferior performance, and shorter~     survival than standard criteria donor kidneys. The current standard of care for kidney graft~     preservation prior to transplantation is static cold storage. Preliminary results from large~     animal kidney transplantation studies and a human clinical trial suggest that normothermic~     machine perfusion of kidneys prior to transplantation may ameliorate the injury sustained by~     kidney grafts during cold static preservation, allow assessment of organ viability prior to~     transplantation, and reduce the risk of delayed graft function or non-function. Such a~     strategy may not only improve the performance of kidneys that are currently considered~     acceptable for transplantation, but may also facilitate the assessment and utilization of~     kidneys that are currently not considered for transplantation. This study will examine the~     feasibility and safety of normothermic ex vivo perfusion of human kidneys prior to~     transplantation. The study will evaluate kidney function after transplantation using standard~     clinical parameters. Study participants will be followed for 3 months following~     transplantation and their outcomes recorded. Feasibility will be measured using the ratio of~     actual:eligible kidney grafts preserved by normothermic ex vivo perfusion and will also take~     into account logistical issues with respect to implementation and ease of use of the ex vivo~     perfusion device. Safety will be assessed by rates of device failure resulting in organ~     discard, primary graft non-function, delayed graft function, graft failure, and recipient~     mortality.~   "
32850|NCT03137043|"~     Asthma is a chronic disease. Prevalence of asthma in 2014 among Spanish population was 5%, of~     which 10% were diagnosed with severe asthma. According to Spanish National Guideline for the~     Management of Asthma (GEMA) 4.1 criteria, asthma can be classified according to its severity~     (intermittent, mild persistent, moderate persistent or severe persistent) or level of asthma~     control (controlled, partly controlled or uncontrolled). This Guideline describes that only 1~     in 10 subjects with severe asthma is well controlled, meaning that there is a 90% prevalence~     of non-controlled severe asthma.~      This prospective, non-interventional, observational, multicenter and case-control study aims~     to assess the prevalence of severe asthma in Spanish Hospitals. The study will describe the~     characteristics of severe versus non-severe asthmatic subjects, assess their eligibility to~     receive biological treatments approved for this disease, resource consumption and evaluate~     the most prevalent phenotypes of severe asthma in Spain. Enrolled subjects will be divided~     into two cohorts, based on asthma severity according to the Global Initiative for Asthma~     (GINA) and the International European Respiratory Society (ERS)/American Thoracic Society~     (ATS) Guidelines. Cohort A: subjects diagnosed of severe asthma and Cohort B: subjects with~     non-severe asthma. Approximately 320 severe asthmatic subjects and 160 non-severe asthmatic~     subjects will be enrolled in the study. A software of big data will be used to do a sub study~     for comparing the results obtained through this software tool against results obtained~     through Gold standard classical methods used in this prospective observational study (the~     descriptive assessment of severe asthma prevalence and the prospective evolution of~     subjects).~   "
32851|NCT03137030|"~     This clinical trial is being conducted to compare concentrations of hydrocodone and~     acetaminophen in the blood after administration of different amounts of tablets of a new and~     a marketed tablet formulation in healthy adults.~      Part 1 is a randomized, single-site, open-label, 4-treatment, 4-period crossover, single oral~     dose Phase I trial in 32 healthy male and female subjects. Part will consist of an Enrollment~     Visit, 4 treatment periods (each lasting approximately 90 hours), and a Final Examination.~     The treatment periods will be separated by a washout period each lasting at least 7 days.~      Part 2 is optional and depending on pharmacokinetic data review after Part 1. It is a~     randomized, single-site, open-label, 2-treatment, 2-period crossover, single oral dose part~     in healthy male and female subjects. Part 2 will consist of an Enrollment Visit, 2 treatment~     periods (each lasting approximately 90 hours) and a Final Examination. The treatment periods~     will be separated by a washout period lasting at least 7 days.~      Participants must fast for approximately 10 hours prior to administration of Investigational~     medicinal product (IMP) and until approximately 4 hours after the administration of the IMP.~   "
32852|NCT03137017|"~     This clinical trial is being conducted to compare concentrations of hydrocodone and~     acetaminophen in the blood after administration of a new and a marketed tablet formulation~     under fasted and fed conditions in healthy adults.~      This is a randomized, single-site, open-label, 4-treatment, 4-period crossover, single oral~     dose Phase I trial in 32 healthy male and female subjects.~      The trial will consist of an Enrollment Visit, 4 treatment periods (each lasting~     approximately 60 hours) separated by 3 washout periods (each lasting at least 7 days), and a~     Final Examination.~   "
32853|NCT03137004|"~     A single-arm phase II study to evaluate the efficacy and safety of docetaxel plus S-1 (DS) as~     second-line treatment in patients with AGC.~   "
32854|NCT03136991|"~     This is a Phase I study to investigate the safety and tolerability of AZD4831 in healthy male~     participants, conducted at a single center. The results from this study will form the basis~     for decisions on future studies. Another purpose of this dose escalation study is to find out~     the right dose of the experimental drug to be given to study participants in future studies.~     Even though there were no harmful effects seen in the animals tested, investigator does not~     know what side effects the experimental drug might cause in humans. However, site personnel~     managing the study participants will be blinded to the extent possible and as long as~     possible to minimize any impact on data collection. Study participants will be blinded to~     treatment allocation.~      The study will be conducted in healthy participants to avoid interference from disease~     processes or other drugs.~      The participants will stay at the study center during the whole dosing period and until 48~     hours post final dose.~   "
32855|NCT03136978|"~     Accumulating evidence suggests that the peritoneal microenvironment of women affected by~     endometriosis undergoes a number of local inflammatory-reparative phenomena, with the~     involvement of resident macrophages, and the attraction and recruitment of peripheral~     mononuclear cells (monocytes and lymphocytes) from the blood into the peritoneal cavity:~     during endometriosis a breakdown occurs in endometrial and peritoneal homeostasis caused by~     cytokine-addressed cell proliferation and dysregulation of apoptosis.~      The surrounding microenvironment may address the macrophage plasticity towards a transient~     and reversible polarization. These polarized phenotypes reflects the proinflammatory or~     anti-inflammatory status and may change over the time. They could be functionally classified~     in two main populations: classically activated macrophages (M1) and alternatively~     activated macrophages (M2).~      Considering that published data so far are still not robust enough to drawn firm conclusion,~     the aim of this research project will be to evaluate M1 and M2 macrophages in endometriotic~     tissue from women affected by endometriosis at different stages.~   "
32856|NCT03136965|"~     The overall goal of this research is to find an effective treatment for patellar tendinopathy~     (PT). To achieve this, we will conduct a double-blinded randomized controlled trial to~     investigate if platelet-rich plasma is effective for treatment. Clinical (pain and function~     scores) and bio-mechanical (knee strength) measures will be correlated with disease~     modification changes assessed using conventional and novel quantitative magnetic resonance~     imaging (MRI) and ultrasound (US) techniques.~   "
32866|NCT03136835|"~     A pilot study investigating the safety and feasibility of chronic maternal hyperoxygenation~     in the setting of fetal congenital heart disease~   "
32867|NCT03136822|"~     (DERMALIX) (Patent number: PCT/TR2014/000251) is a bioactive wound dressing that was~     developed by Ege University School of Pharmacy Department of Pharmaceutical Technology. This~     dressing has been categorised as Class III medical device. This clinical study will be~     conducted in patients with diabetic foot ulcers.~   "
32868|NCT03136809|"~     Treatment extension study for ALS/MND patients who participated in phase 1 study~     CMD-2016-001, completed assessments following six 28-day cycles of treatment, and whom the~     Investigator considers would benefit from continued CuATSM treatment.~   "
32857|NCT03136952|"~     Children who undergo surgery routinely for surgery that risk high levels of circulatory~     changes (eg heart surgery) is currently used routinely monitoring as regional oxygenation~     technology of the brain (NIRS). Near infrared spectroscopy (NIRS) is a technique for~     measuring regional oxygen saturation, indirect autoregulation of brain. We know that reduced~     oxygenation of the brain can occur with severe immediate blood loss. We in the research group~     has been able to note that in children who undergo surgery for cranioplasty interventions <1~     year old, when they have ongoing excessive bleeding, decreases oxygenation in the brain and~     sometimes sharply before we can replace the loss of blood, even the blood pressure can be~     adequately maintained. Perioperative hypovolemia is a risk factor upset autoregulation of~     brain. Respect of which the mean arterial pressure (MAP) required to maintain intact~     autoregulation during general anesthesia still lacks a scientific consensus.~      By illuminating the skin and underlying tissue with infrared light in the spectra of 700 to~     1100nm, it is possible to measure regional oxygen saturation in various tissues. At cerebral~     measuring sensor is placed frontally, just below the hairline. INVOS then returns the~     absolute values of cerebral oxygen saturation frontally in the area where the sensor is~     placed.~      A frontal placement may in some cases be impractical / impossible and thus limits the ability~     to monitor the brains of children with different types of surgery or body positions. At~     certain cranioplastic intervention surgery a frontal placement is not always possible, partly~     because of surgical technic reasons, but also that the child may have to lie prone during~     surgery. An alternative placement of INVOS sensor could mean greater opportunities to monitor~     cerebral oxygen saturation and thus increase patient safety within the mentioned categories~     of patients. An occipital location is practically possible in many cases. The purpose of this~     study is to investigate whether a occipital located sensor can measure cerebral oxygen~     saturation in a reliable manner.~   "
32858|NCT03136939|"~     10 type 1 diabetes, 10 type 2 diabetes and 10 healthy controls matched with age and sex were~     enrolled in our study and their periphera blood mononuclear cells (PBMC) were isolated. We~     implemented ELISPOT(Enzyme-linked Immunospot Assay) to detect the interferon-γ (IFN-γ）which~     secreted by IGRP-specific T cell. Results were compared between these groups.~   "
32859|NCT03136926|"~     Adequate antifungal therapy is a critical determinant of survival in patients admitted to an~     Intensive Care Unit (ICU) with suspected or proven fungal infections. Critical illness can~     alter the way human body handles antifungal agents, i.e. how the drugs are distributed in the~     body and removed from the body. Consequently, these changes can increase the risk of~     inappropriate antifungal exposure that may lead to adverse consequence on patients' outcome.~     Developing an evidence-based antifungal dosing guideline is of global significance and should~     be considered a priority to improving clinical outcomes for patients receiving antifungal~     agents~      The aim of the SAFE-ICU Study is to develop optimised antibiotic dosing guidelines for ICU~     patients with life-threatening infections that account for patient characteristics. This will~     be achieved through completion of the following aims:~      i) Describe detailed demographic, clinical and plasma antibiotic concentration-time data in a~     large ICU patient cohort; ii) Perform a robust statistical analysis of the data collected in~     Aim 1 to develop an enhanced preliminary prediction algorithm for antifungal dosing.~      This is a multi-national study and will enrol ICU patients who are prescribed an antifungal~     agent (fluconazole, voriconazole, posaconazole, isavuconazole, caspofungin, anidulafungin,~     micafungin or amphotericin B). A minimum of 12 patients per drug will be enrolled across at~     least 15 countries and up to 80 ICUs.~      Eligible patients are those admitted to the ICU, who are prescribed an antifungal agent~     (fluconazole, voriconazole, posaconazole, isavuconazole, caspofungin, anidulafungin,~     micafungin or amphotericin B). Blood samples will be taken to measure drug concentration.~     Sampling will occur on two occasions, first during study days 1-3 and then a second time~     between days 4-7, each over an 8-24 hour period. Blood samples will be taken from a vascular~     access device already inserted for ICU patient care. Abdominal samples from abdominal~     indwelling drains already inserted peri operatively will also be collected on these two~     occasions in the subgroup of patients with intra-abdominal infection. Data on infection,~     various blood tests and patient specific data will be collected using a structured case~     report form (CRF). Patients will also be followed up 30 days after enrolment into the study~     to evaluate 30-day mortality.~      Collected samples will be frozen and stored locally and then shipped in large batches for~     processing at Burns Trauma and Critical Care Research Centre, The University of Queensland,~     Australia. Data analysis for development of antifungal dosing algorithms will also be~     undertaken at The University of Queensland, Australia.~   "
32860|NCT03136913|"~     This study is being conducted to compare the outcomes of two separate surgical techniques~     used in tooth extraction and ridge preservation. Ridge preservation is done to potentially~     minimize the amount of bone loss that occurs between the tooth extraction and implant or~     bridge placement, as compared to leaving the extraction site empty. There are two techniques~     that are commonly used for these procedures, either to close the surgical site of the~     extracted tooth with sutures (closed flap technique) or to leave the extraction site open to~     heal naturally (open flap technique). In the open flap technique there will be sutures used~     to secure and hold down the material used to cover the wound, called a non-resorbable~     membrane. The flaps will remain in their natural position, the site will fill up naturally~     with new tissue from the bottom up and then close itself in from the sides. The investigators~     want to see which technique offers better healing and reduces bone loss.~   "
32861|NCT03136900|"~     An adequate nutritional support after a cardiac surgery enhances the morbidity and mortality.~      After a cardiac surgery, the energy expenditure is estimated to be around 55 kcal/kg/d. The~     caloric intake is not the only important nutritional variable in PICU. The protein intake~     objective is around 1,5g/kg/d in order to reduce muscular catabolism.~      The aim of this study is to compare the impact of an isocaloric enteral diet, either~     fortified by milk concentration (in order to increase the protein intake) or by a supplement~     of maltodextrin and oil in children from 0 to 2 years, after surgery for congenital heart~     disease.~   "
32862|NCT03136887|"~     This study was designed to demonstrate the safety and performance of the JOURNEY II XR total~     knee system by evaluating implant survival rates at 10 years using Kaplan-Meier analysis. All~     participants will be implanted with the JOURNEY II XR total knee system.~   "
32863|NCT03136874|"~     The main objective is to study donors' personality and motivations characteristics of the~     different recruitment methods and thus to answer questions related to the donation's~     approach, its representations as well as motivations and the profile of the donors.~   "
32864|NCT03136861|"~     The purpose of the study is to evaluate the efficacy and safety of secukinumab 150 mg~     compared to placebo in the early management (Baseline to Week 8) of spinal pain, disease~     activity, fatigue and predictability of disease flares in patients with axial~     spondyloarthritis who have an inadequate response to prior non-steroidal anti-inflammatory~     drugs. This study will also assess the efficacy and safety of secukinumab 300 mg compared to~     secukinumab 150 mg from Week 8 to Week 24 in order to assess the potential additional~     benefits of dose escalation in patients with axial spondyloarthritis.~   "
32878|NCT03136679|"~     This study will perform a targeted metabolic analysis in blood and urine samples from~     subjects attending the Baylor AT&T Memory Center. The aim is to identify novel biomarkers~     that can distinguish normal aging subjects with no cognitive impairment from those with mild,~     moderate or severe cognitive impairment associated with Alzheimer's disease. Subjects will~     also be screened for B-vitamin deficiencies that may correlate with other metabolic~     biomarkers and Alzheimer's disease.~   "
32879|NCT03136666|"~     The objective of the study was to investigate the pharmacokinetics as well as safety and~     tolerability of a concomitant administration of nifedipine GITS and candesartan tablets under~     fasting conditions in healthy male subjects.~   "
32869|NCT03136796|"~     GCX damage and its relationship to pharmacodynamics and pharmacokinetics of beta lactam~     antibiotics in critically ill Hypothesis to be tested: GCX damage impairs pharmacodynamics~     and pharmacokinetics of beta-lactam antibiotics in critically ill patients. There is~     correlation between GCX damage and insufficient beta lactam levels in patients with commonly~     used dosing. The aim of the study: Evaluation of relationship between GCX damage and~     pharmacodynamics and pharmacokinetics of beta-lactam antibiotics in critically ill. Type of~     the study: Observational. Subjects: Adult patients admitted to ICU with beta-lactam~     antibiotic therapy (meropenem or piperacillin/tazobactam empirically or based on culture~     results). Sample size calculation: 20 patients (expected correlation coefficient 0,6, alpha~     error = 0,05) will lead to power study = 0,89. Intervention: none. Data to be recorded and~     analyzed: Demographics, type of patients (trauma, post surgical, medical, after cardiac~     arrest), severity score - Apache II, SOFA, fluid balance, a presence of delirium, clinical~     outcome, sublingual microcirculation by SDF imaging will be recorded three times during~     antibiotic treatment at the time points for blood samples required for pharmacodynamics and~     pharmacokinetic analysis, microcirculatory data and Perfused Boundary Region.~   "
32870|NCT03136783|"~     The choice of treatment of patients with metastatic melanoma depends on the status of B-RAF~     of the tumor: in the absence of mutation, treatment with immunotherapy (currently anti-PD1)~     is proposed in the first line; When B-RAF is mutated, treatment with targeted therapies is~     retained: B-RAF and MEK inhibitors are prescribed in combination (vemurafenib + cobimetinib~     or dabrafenib + trametinib).~      Patient response rates for targeted therapies range from 50 to 60%, and the occurrence of~     sometimes severe side effects is not predictable. There are currently no predictive~     biomarkers of patients' response to targeted therapy molecules. The in vitro evaluation of~     the intrinsic sensitivity of the cells of patients to different combinations of targeted~     therapy molecules would make it possible to propose the best therapeutic combinations. The~     cutaneous metastases are chosen in the model because of easy access to collect tumor tissue.~      The most relevant in vitro models for mimicking cutaneous melanoma metastases are explant~     cultures and human skin equivalents.~   "
32871|NCT03136770|"~     A study to assess the pharmacokinetics and safety of CK-30 600 mg (Compound K) and red~     ginseng extracts 2.94 g after a single oral dose in healthy male volunteers~   "
32872|NCT03136757|"~     Graft-versus-host disease (GVHD) is a frequent and severe complication of hematopoietic stem~     cell transplantation (HSC), and is responsible for significant early mortality despite~     prophylactic strategies developed in recent decades, Especially since it is resistant to~     first-line treatment.~      The present diagnosis is difficult, non-specific and is based on the combination of an~     evocative clinical context (CSH allograft, time to appearance before J100, characteristic~     clinical manifestations), suggestive anatomo-pathological analysis (predominantly~     inflammatory infiltrate Lymphocyte, mucosal edema and presence of apoptotic bodies), and the~     exclusion of any differential diagnosis (in particular serology / negative viral PCR).~      However, to date there is no molecular characterization of this manifestation, and therefore~     no specific treatment.~      The nCounter® nanostring technology allows the rapid and simple analysis of the simultaneous~     expression of a group of genes (up to 800 on the same sample), from a very small amount of~     RNA, and from samples with difficulty Such as fabrics already fixed to formaldehyde and~     included in paraffin. It allows the detection of a molecular signature of the tissue~     analyzed.~      No transcriptomic analysis has ever been performed on human tissues with GVHD.~   "
32873|NCT03136744|"~     Activity recommendations for the general population and those with multiple sclerosis (MS)~     focus on the promotion of activity that has a moderate intensity - in other words, activity~     intense enough to breathe heavily and sweat. Most adults do not achieve the recommended 150~     minutes of moderate-intensity activity per week. Even fewer persons with MS meet the~     recommendations. Those with MS often have problems with walking and fatigue, thus it is not~     difficult to understand that moderate intensity activity is challenging. Our study will test~     the feasibility of a new approach focusing on activity over the whole day - promoting light~     activity such as standing or walking around the house while reducing prolonged sitting~     (sedentary behaviour). This approach is supported by research evidence showing that too much~     sedentary time, especially prolonged bouts of sitting, is associated with health risk factors~     such as obesity and cholesterol level. Recent work with persons with MS confirms that~     prolonged sitting is a problem for this population and emphasises the potential importance of~     this approach.~      This study tests the feasibility of an internet-based intervention designed to decrease~     sedentary behaviour and to increase upright time in people with MS.~   "
32874|NCT03136731|"~     Main aim: To find evidence-based screening strategies for celiac disease in high risk groups~     and to find new biomarkers or biomarker combinations for celiac disease diagnostics and~     follow-up.~   "
32875|NCT03136718|"~     This study will establish the feasibility of a theoretically-driven, personalised educational~     intervention delivered through mobile technologies in first-time hearing aid users. Namely,~     the C2Hear (https://www.youtube.com/C2HearOnline) multimedia videos, or Reusable Learning~     Objects (RLOs) (Ferguson et al., 2015; 2016), will be repurposed into short 'bite-sized'~     mobile-enabled RLOs (mRLOs).The development of the intervention will be based on a recently~     developed comprehensive model of health behaviour change (COM-B) (Michie et al., 2014). The~     intervention will be tailored to individuals' needs, and incorporate greater user~     interactivity and self-evaluation.~   "
32876|NCT03136705|"~     STUDY SUMMARY Title: EFFECTS OF NICOTINAMIDE AND LANTHANUM CARBONATE ON PHOSPHORUS~     HOMEOSTASIS Protocol Number:STU00090161 Phase: Phase 1, detailed physiologic study~     Methodology: double blind, randomized, placebo-controlled, 2x2 factorial Study Duration:~     12-18 months (to complete the entire study protocol) Study Center: Single-center Objectives:~     Define short-term effects of the interventions (lanthanum carbonate and nicotinamide) on~     indices of phosphate handling Number of Subjects: 80 Diagnosis and Main Inclusion Criteria:~     Healthy volunteers Study Product(s), Dose,Route, Regimen: Nicotinamide, 750 mg by mouth twice~     daily, Lanthanum carbonate, Fosrenol, 1000 mg by mouth three times daily with meals Duration~     of administration: 2 weeks (length of time study participants are enrolled in study)~     Reference therapy: reference is a placebo Statistical Methodology: Repeated measures analysis~     using mixed linear models~   "
32877|NCT03136692|"~     The study team analyzed de-identified user data provided by the commercial app Lose It!, an~     entity of FitNow, Inc.~   "
32880|NCT03136653|"~     The purpose of this study is to assess the efficacy, safety, tolerability, pharmacokinetics~     (PK), immunogenicity and biological activity of MP0250 in combination with bortezomib +~     dexamethasone in patients with refractory and relapsed multiple myeloma (RRMM).~      MP0250 is a multi-DARPin with three specificities, able to simultaneously neutralize the~     activities of vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF)~     and also to bind to human serum albumin (HSA) to give an increased plasma half-life and~     potentially enhanced tumor penetration.~   "
32881|NCT03136640|"~     This is a safety, feasibility and pharmacokinetic study to confirm that the recommended safe~     dose and schedule of ModraDoc006/r (oral docetaxel with ritonavir) as determined in a~     previous phase I study is also safe and feasible in the target population of patients with~     CRPC.~   "
32882|NCT03136627|"~     This study will evaluate the safety, tolerability, dose-limiting toxicities, MTD, and~     preliminary anti-tumor activity of tivozanib in combination with nivolumab in subjects with~     metastatic renal cell cancer. This will use a standard '3+3' dose-escalation trial design. A~     cohort of 3 subjects will be enrolled at each dose level. If 1 of 3 subjects experiences a~     DLT during Cycle 1, that dose level will be expanded to 6 subjects. If 0 of 3 or ≤ 1 of 6~     subjects experience a DLT during Cycle 1, escalation to the next dose will occur. If ≥ 2 of 6~     subjects experience a DLT during Cycle 1, dose escalation will stop and the prior dose will~     be considered the MTD. This is a validated trial design for Phase 1 trials.~      Following completion of the dose-escalation cohorts and determination of MTD, an expansion~     cohort of up to 20 subjects may be enrolled at MTD to further evaluate safety, tolerability,~     and preliminary anti-tumor activity of tivozanib in combination with nivolumab in the same~     target population.~   "
32883|NCT03136614|"~     To investigate how pulse wave velocity, aortic augmentation index and the arterial pulse wave~     given by the Arteriograph contributes to preoperative assesment, intraoperative and intensive~     care monitoring.~   "
32884|NCT03136601|"~     The overall objective of this study is to compare the efficacy of the standard monthly~     maintenance therapy for percutaneous tibial nerve stimulation (PTNS), to sessions as the~     patient needs (prn) between 2 weeks and 12 weeks, based on overactive bladder symptoms. This~     is study is to help determine feasibility for conducting a larger trial that is appropriately~     powered to provide meaningful data.~   "
32885|NCT03136588|"~     Immunosuppression non-adherence in kidney transplant recipients (KTRs) not only increases the~     risk of medical intervention due to acute rejection and graft loss but burdens the~     socioeconomic system in the form of increased healthcare cost. Aggressive preemptive effort~     by healthcare professionals geared to ensure adherence to immunosuppressants in KTRs is~     significant and imperative.~      This study was designed as a prospective, randomized, controlled, and multicenter study aimed~     at evaluating efficacy and stability of the information and communication technology~     (ICT)-based centralized monitoring system in boosting medication adherence in KTRs.~      This study is based upon work supported by the Ministry of Trade, Industry & Energy (MOTIE,~     Korea) under Industrial Technology Innovation Program ( No. 10059066, 'Establishment of ICT~     Clinical Trial System and Foundation for Industrialization').~   "
32886|NCT03136575|"~     This study aimed to observe how a six week qigong program influence patients with head and~     neck cancer during active radiotherapy treatment course. The quality of life, sleep~     dysfunction or depression and shoulder and neck function will be accessed by questionnaire,~     and ANS function will be objectively investigated using heart rate variability measurement.~   "
32887|NCT03136562|"~     The primary purpose of this study is to determine the prevalence of adrenal insufficiency in~     a population of patients with kidney transplants receiving low dose prednisone treatment.~      Development of glucocorticoid-induced adrenal insufficiency is a serious adverse effect to~     glucocorticoid treatment. The study includes a control group of patients with kidney failure~     currently treated in dialysis, who are not in glucocorticoid treatment.~      Individual genotyping is performed to determine the haplotype of glucocorticoid receptor~     polymorphisms: N363 S, BclI, ER23/23EK and 9β in all the patients with the purpose of~     investigating this as a risk factor for the development of adrenal insufficiency. The~     hypothesis is that subjects with one or another of the polymorphisms in the glucocorticoid~     receptor gene will either have increased or diminished glucocorticoid sensitivity.~      Using validated questionnaires assessing the quality of life and functional level of the~     patients enrolled in the study we aim to establish a link between functional level and~     biochemically proven adrenal insufficiency.~      Other secondary outcomes in the study includes bloodpressure, body composition, bone density,~     metabolic syndrome, inflammation and salivary cortisol profiles.~   "
32888|NCT03136549|"~     Epistaxis or post-pharyngeal bleeding is the most common complication after nasotracheal~     intubation (NTI). Prior thermal softening of the endotracheal tube (ET) has been recommended~     as one of the methods to prevent nasal trauma from nasotracheal intubation. However, thermal~     softening of tubes tends to adversely affect the nasotracheal navigation of the ET.~      During NTI under conventional direct laryngoscopy, the tip of the Macintosh laryngoscope is~     advanced into the vallecula, indirectly elevating the epiglottis by applying pressure on the~     hyoepiglottic ligament. Although this maneuver allows optimal visualization of the glottis,~     it lifts the larynx away from the tip of the advancing nasotracheal tube (NTT), which~     generally lies along the posterior pharyngeal wall. Most clinicians use Magill forceps to~     direct the tip of the NTT anteriorly to enter the glottis. Magill forceps may cause damage to~     the cuff of an ET or may injure oropharyngeal mucosa.~      The use of a video laryngoscope and a cuff inflation technique has been proposed as a method~     for reducing the malalignment of tubes. Indirect laryngoscopy using a Video laryngoscopy can~     reduce malalignment by minimizing lifting the glottis during laryngoscopy. The cuff inflation~     technique (wherein the cuff of ET tube is inflated with 15 mL of air) has been used while~     performing blind NTI to guide such malaligned polyvinyl chloride (PVC) ET tubes into the~     laryngeal inlet. Recently, one study reported that the cuff inflation technique consistently~     improved the oropharyngeal insertion of the different ET tubes of varying stiffness during~     direct laryngoscope-guided NTI.~      There has never been study about effect of cuff inflation technique on navigability when~     performing NTI under video laryngoscopy guidance with ET tubes of varying~     stiffness.Investigators assessed and compared the incidence of nasal injury and nasotracheal~     navigability with two technique during cuff inflation-supplemented NTI guided by video-~     laryngoscopy~   "
32937|NCT03135912|"~     This is a three-arm randomized controlled trial to assess the efficacy of an experimental~     treatment in the treatment of tinea pedis (athlete's foot). The experimental treatment will~     be tested against a vehicle control to determine efficacy and safety, and against an active~     comparator to evaluate the success of the treatment relative to an existing gold-standard~     treatment. Patients will be treated for four weeks, with their condition being assessed at~     the end of treatment and two weeks after the end of treatment. The primary endpoint for this~     study is effective treatment rate at the week 6 evaluation, defined as a mycological cure and~     minimal clinical signs & symptoms. Secondary endpoints include safety and patient evaluation~     of treatment.~   "
32889|NCT03136536|"~     The purpose of this study is to investigate the mortality and frequency of organ dysfunction~     in patients after endovascular thoracoabdominal aortic surgery, and to search for biomarkers~     of organ dysfunction, in particular the spinal cord, the kidneys and the gastrointestinal~     tract. All adult patients undergoing endovascular thoracoabdominal aortic surgery at Örebro~     University Hospital, Örebro, Sweden, are asked for participation in this study. All~     participating patients sign informed consent at the inclusion. During the operation and~     during the postoperative intensive care, the function of the spinal cord, the~     gastrointestinal tract and the kidneys are collected along with other clinical parameters.~     Plasma blood samples, urin samples and cerebrospinal fluid samples are collected from each~     patient during the operation and during the postoperative care at the intensive care unit.~     During the operation two microdialysis catheters are placed in the abdomen, and the samples~     are continuously collected and analyzed. The biomaterial samples are stored in a biobank for~     later determination of proteins and other molecules. Postoperative survival and the frequency~     of complications are analysed.~   "
32890|NCT03136523|"~     Construction of a large cohort of lung cancer patients to evaluate the Prognostic and~     Predictive Significance of the molecular biomarkers Epidermal growth factor receptor (EGFR),~     KRAS, Anaplastic lymphoma kinase (EML4-ALK), Programmed Death-Ligand 1 (PD-L1) protein and~     Microsatellite Instability (MSI) in lung cancer: A tissue microarray-based study of 500~     cases.~   "
32891|NCT03136510|"~     Apixaban is a potent, oral, selective reversible direct inhibitor of factor Xa with a~     favorable efficacy and safety profile in the prevention of non valvular (NV) atrial~     fibrillation (AF). It has been shown, including by our group, that D-dimers levels (molecular~     marker of coagulation activity) are predictive of the events (including mortality) in patient~     with AF independently of the antithrombotic treatment. The aim of the study is to evaluate~     the changes in plasma levels of biomarkers of coagulation activation: D-dimers, prothrombin~     fragments F1+2, von Willebrand factor (vWF) and thrombin-antithrombin complexes (TAT) in~     response to apixaban treatment in patients with NVAF.~   "
32892|NCT03136497|"~     A Study of Venetoclax Plus Ibrutinib and Rituximab in Patients with Relapsed/Refractory~     Diffuse Large B-cell Lymphoma (DLBCL).~      Our hypothesis is that the combination therapy of BTK (Bruton's tyrosine kinase) Inhibitor~     Ibrutinib plus Venetoclax and Rituximab in relapsed or refractory DLBCL will have an~     increased activity with acceptable toxicity. Furthermore, this new novel therapeutic~     combination will be safe and well tolerated among this patient population.~   "
32893|NCT03136484|"~     This trial is conducted in Africa, Asia, Europe, North and South America. The aim of the~     trial is to compare the effect of once-weekly (OW) dosing of subcutaneous semaglutide (1.0~     mg) versus once-daily dosing of oral canagliflozin (300 mg) on glycaemic control in subjects~     with type 2 diabetes (T2D) on a background treatment of metformin~   "
32894|NCT03136471|"~     Investigators propose to use a natural experiment design to examine the impacts of the new~     CPT code (99490) for chronic care management on health outcomes. The Investigators will~     collaborate with partners in the Louisiana Clinical Data Research Network (LaCDRN) who serve~     more than 90,000 patients with type 2 diabetes mellitus in Louisiana to examine impacts of~     the CMS reimbursed care coordination. Now, LaCDRN is renamed as Research Action for Health~     Network (REACHnet). Patient and stakeholder engagement will be planned and implemented across~     all phases of this natural experiment. This project will examine outcome differences created~     by the policy change in a natural experiment framework. The analyses will utilize the RE-AIM~     framework to identify the critical elements of the programs that will enhance the reach,~     effectiveness, adoption, implementation, and maintenance of these strategies in the diverse~     LaCDRN diabetes populations.~   "
32895|NCT03136458|"~     This study evaluates remote ischemic preconditioning as an strategy to avoid contrast induced~     nephropathy. All of the patients will receive endovenous normal saline to prevent~     nephropathy, half of the patients will receive remote ischemic preconditioning while the~     other half will not.~   "
32896|NCT03136445|"~     The purpose of this study is to test whether giving tranexamic acid to patients receiving~     treatment for blood cancers reduces the risk of bleeding or death, and the need for platelet~     transfusions. Patients will be randomised to receive tranexamic acid (given intravenously~     through a drip, or orally) or a placebo.~   "
32897|NCT03136432|"~     Cerebral Palsy (CP) is a group of permanent disorders of movement and posture, generally~     accompanied by secondary musculoskeletal problems. Studies in literature showed taht children~     with CP supports a link between the levels of impairment and walking ability. The 6 Minute~     walk test is a standardized, self-placed walking test commonly used to access functional~     ability in children with cerebral palsy. While decreased exercise capacity has been~     identified in children with cerebral palsy, the clinical determinants of the 6MWT in this~     population have not been investigated yet. Thus the aim of this study is to investigate the~     relationship between 6 Minute walk test, quality of life, respiratory muscle~     strength,activities of daily living using with Pediatric Evaluation of Disability Inventory~     and trunk control.~   "
32898|NCT03136419|"~     Microbiota and innate immunity in pouchitis: predisposing factors and modulation of the~     inflammation with probiotics.~      Around 20-25% of ulcerative colitis patients undergo restorative proctocolectomy with ileal~     pouch anal anastomosis. Pouchitis is an idiopathic inflammatory disease that may occur in~     ileal pouches. In our recent studies, we showed altered microbiota and innate immunity~     relationships in pouchitis. We plain to perform a double-blind, placebo-controlled trial~     probiotic therapy vs placebo starting at the time of ileostomy closure to evaluate the impact~     of microbiota that colonizes the pouch mucosa in the pathogenesis of pouchits, to determine~     how expression and activation status of the innate immunity system in different cell types~     and anatomical districts of pouch mucosa relate to microbiota population and follow-up the~     clinical outcome of anal pouches in light of microbiota-innate immune system interplay.~      Our study will include three phases:~        1. analysis of the intestinal microbiota with High Throughput Sequencing Unit and anaerobes~          cultures~        2. characterization of innate immunity with TLR, NLR, nicotinic receptors and LPMC analysis~        3. assessment of microbiota and innate immune system in the ileal pouch before ileostomy~          closure, 2 months after ileostomy closure and after 1 year follow up.~   "
32899|NCT03136406|"~     This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination~     therapy in subjects with pancreatic cancer who have progressed on or after previous Standard~     of Care first line therapy and chemotherapy.~   "
32900|NCT03136393|"~     High neonatal mortality rates accounts for a substantial early loss of lives in Malawi; and~     has thus been a hindrance for Malawi to eradicate child deaths. From 2000 to 2011, Malawi~     achieved an overall reduction of 23% in under-five child mortality. The reduction was more~     substantial between the second and the fifth year of life, being 28%. However, in the~     neonatal period the reduction was half, at 14%. Neonatal deaths in developing countries are~     due to prematurity or low birth weight, neonatal infections, birth trauma related conditions~     and congenital anomalies.~      Being of low birth weight increases the risk of death four fold in the neonatal period. Even~     when low birth weight infants survive, their poorly developed immune function exposes them to~     increased morbidity in early life. Maternal nutrition represents by far the greatest~     influence among pregnancy environmental on birth weight in low income countries. There is~     strong evidence that health and dietary counselling is effective in improving child nutrition~     outcomes. Thus we propose to test the effectiveness in improving birth weight by a low cost~     intervention, community based health and nutrition counselling delivered to mothers during~     pregnancy in Malawi.~      On the other hand, in the Malawian context offering individualized dietetic counselling could~     be impeded by the healthcare workforce short fall. Currently the health workforce does not~     include dieticians . The use of lay health workers (LHW) has been identified as one of the~     effective strategies to meet the health workforce shortage challenges in low resource~     settings.~      It is on this basis that a study was planned, aimed at developing lay health worker delivered~     community based nutrition counselling to mothers during pregnancy and measuring its~     effectiveness in improving birth weight in the Malawian context. The study was comprised of~     an initial i) formative study, followed by ii) a cross-sectional survey. Findings of these~     two sub-studies were utilized to develop a nutrition counselling intervention. Finally iii) a~     cluster Randomized Controlled Trial (cRCT) aimed at measuring the effect of the intervention~     on birth size (weight, length, arm and abdominal circumferences) will now be conducted which~     is being elaborated in this protocol.~   "
32901|NCT03136380|"~     Danirixin is a selective chemokine receptor antagonist being developed as a potential~     anti-inflammatory agent for the treatment of chronic obstructive pulmonary disease (COPD).~     The aim of the study is to assess the safety, tolerability and pharmacokinetics (PK) in~     healthy Japanese subjects over the age of 65 years (inclusive). The study will be conducted~     in two parts: Part 1 will be a double blind, placebo-controlled, 3-period crossover,~     ascending single oral dose administration of GSK1325756H (Hydrobromide Salt Tablet~     Formulations of Danirixin) 10, 50 and 100 milligram (mg) in the fed condition. Part 2 will be~     an open label, 2-period crossover, single oral dose of GSK1325756H 50 mg in fed and fasted~     state. This study will provide an understanding of PK of hydrobromide salt of GSK1325756 in~     population of healthy elderly subjects and also contribute to the selection of appropriate~     dosing for Phase IIa study in Japan.~   "
32902|NCT03136367|"~     What Matters Most is a study that aims to determine how best to help women of lower~     socioeconomic status make high-quality decisions about early stage breast cancer treatments.~     What Matters Most will be comparing two decision aids used in the clinic visit to usual care~     (what normally happens in the clinic). The first decision aid (Option Grid) presents~     evidence-based information about lumpectomy and mastectomy in a tabular format using text~     only. The second decision aid (Picture Option Grid) presents evidence-based information about~     lumpectomy and mastectomy using pictures, pictographs and simplified text. What Matters Most~     aims to show that the interventions can reduce disparities in decision-making and treatment~     choice between women of high and low SES.~   "
32903|NCT03136354|"~     The investigators compared the perioperative, oncological, functional and immunological~     outcomes of endoscopic submucosal dissection against laparoscopic assisted gastrectomy for~     treatment of early gastric cancer. With virtually no abdominal incisions and minimal pain~     induced, endoscopic submucosal dissection is expected to be less invasive when compared to~     laparoscopic assisted gastrectomy for treatment of early gastric cancer. This study will show~     that endoscopic submucosal dissection is associated with a significantly better perioperative~     recovery and less immunological disturbance. Moreover, it will also induce a better long term~     outcomes as the stomach can be preserved, hence the digestive function is maintained to~     prevent long term functional morbidities of the gastrointestinal tract.~      This study will be the unique first study in the literature to show that intramucosal early~     gastric cancer can be adequately treated by endoscopic submucosal dissection with better~     perioperative, functional and quality of life outcomes when compared to laparoscopic assisted~     gastrectomy.~   "
32904|NCT03136341|"~     Task-dependent upper limb tremor is a disorder that frequently impairs patients' function and~     quality of life. Few studies exist that quantify the improvements in motor performance and~     disability with botulinum toxin (injections). The study team aims to perform an exploratory~     pilot trial using toxin Type A (Dysport) in 25 patients with task-dependent upper limb~     tremor, to refine quantitative measures of performance using blinded video analysis,~     demonstrate efficacy and tolerability of injections, and provide power calculations for a~     potential future multi-centered double blinded clinical trial.~   "
32905|NCT03136328|"~     About 40 patients with histologically and/or clinically confirmed and/or suspected NET are~     anticipated to be enrolled during 3 years from initiating the study.~      Patients will be recruited at Montefiore Medical Park where there is a medical group~     specialized in the diagnosis and treatment of NETs. Each patient will undergo a screening~     visit within 14 days prior to receiving study medication.~      The primary goal of the analysis is to estimate the diagnostic accuracy of 68Ga-DOTATOC PETCT~     for detecting NET compared to conventional imaging techniques.~   "
32906|NCT03136315|"~     During ultra endurance events, athletes experience extreme physical and mental demands,~     sometimes at the limits of the adaptive response to human physiology. This is particularly~     true for the renal function, and some evidence for acute renal failure has already been~     shown, sometimes leading to dialysis. However, the precise mechanisms involved in acute renal~     failure in such ultra endurance races are not clearly elucidated.~      The aim of our study is to estimate glomerular filtration rate from serum and urinary~     creatinine and cystitin C at the beginning and at the end of a 110 km ultra endurance race.~     Our hypothesis is that during the ultra endurance race, renal function may be injured, with a~     risk for the athlete.~   "
32907|NCT03136302|"~     The goal is to establish another anatomical referencing system in order to achieve an even~     higher accuracy when implanting stimulation electrodes.~   "
32908|NCT03136289|"~     The aim of this study was to examine the association between family consumer behaviors~     (healthy food availability and supermarket spending) and adolescent prediabetes and diabetes.~   "
32909|NCT03136276|"~     When restoring teeth with IPS Empress laminate veneers, fracture of restorations may occur.~     So, material with higher mechanical properties is required. Celtra Duo is a new material with~     glass ceramics infiltrated by 10% zirconia particles which increase the fracture resistance~     of the material.~   "
32938|NCT03135899|"~     The primary objective of this study is to investigate safety and tolerability of three~     consecutive administrations, 12 hours apart, at three different dose-levels of BI 443651~     administered via oral inhalation in male and female mild asthmatic subjects after a bolus~     methacholine challenge.~   "
32910|NCT03136263|"~     This is a randomized, double-blind, placebo-controlled crossover study of single-dose~     intranasal oxytocin (24 IU) in 18-55 year-old men with attention deficit/hyperactivity~     disorder (ADHD). Following a screening visit to determine eligibility, subjects will return~     for two main study visits. During the main study visits, study participants will receive~     either oxytocin (Syntocinon® nasal spray, Victoria Pharmacy, Zürich, Switzerland) or placebo~     (inactive ingredients of Syntocinon® nasal spray, Victoria Pharmacy), followed by assessments~     of cognitive control over attention and behavior. Twenty-four participants will be randomized~     1:1 to one of two drug orders, i.e., oxytocin - placebo or placebo - oxytocin. In an~     additional neuroimaging substudy, a subset of participants will undergo task-based and~     resting-state functional magnetic resonance imaging (fMRI) following oxytocin/placebo~     administration to investigate the effects of oxytocin on fMRI activation and functional~     connectivity within the cognitive control network.~   "
32911|NCT03136250|"~     Neck pain is among the most common musculoskeletal disorders worldwide and is an important~     public health issue in terms of personal wellbeing. Prevalence of neck pain show excessive~     variations, with a point prevalence varying between 6% and 22%, and one year prevalence~     ranging between 1.5-75%. Neck pain like all other mechanical disorders leads to pain,~     disability and decreased range of motion (ROM). Stretching is a very common exercise~     performed by sportsmen, elderly, in physical therapy and rehabilitation patients, thus~     practiced in all sorts of fitness programs. The major types of stretching included in the~     literature are static, dynamic and pre-contraction stretching; of which static stretching is~     the conventional type of stretching. The different types of pre-contraction stretching~     include Proprioceptive Neuromuscular Facilitation (PNF) stretching, Post Isometric Relaxation~     (PIR), Post Facilitation stretch (PFS) and Active Isolated Stretch (AIS). Pre-contraction~     stretching is also considered a part of Muscle Energy Technique (MET). Recently MET and~     pre-contraction stretching have been shown to have significant superiority over conventional~     stretching in management of mechanical neck pain, but the evidence is currently lacking~     regarding which of the two pre-contraction stretching protocols, namely autogenic and~     reciprocal inhibition is more effective than the other. A RCT will be conducted in order to~     find and compare the effectiveness of conventional stretching and pre-contraction stretching~     (autogenic inhibition and reciprocal inhibition). One Control group (conventional group) and~     two Experimental groups (Experimental Group A - Autogenic Inhibition & Experimental Group B -~     Reciprocal Inhibition) will be formed. The participants will be recruited in the study if~     they meet the inclusion criteria using consecutive sampling from Fauji Foundation Hospital~     and randomized into the three respective groups. All the groups will receive the gold~     standard treatment for chronic neck pain including mobilization and modalities. In addition~     to the gold standard treatment the participants will receive specific stretching protocol~     based on their interventional group~   "
32912|NCT03136237|"~     This is an open-label, three part study to evaluate the effect of BCX7353 on drug~     transporters as well as the effect of an inhibitor of drug transport on BCX7353.~   "
32913|NCT03136224|"~     Since circumcision is a significant workload for surgeons working at the rural state~     hospitals in Turkey, the use of circumcision techniques that are easy to implement and have~     low complications is becoming widespread. In this study, thermocautery, plastic clamping, and~     conventional (open surgical) circumcision techniques were compared to each other in terms of~     their short and long term complications.~   "
32914|NCT03136211|"~     This study examines the effectiveness and the costs of a complex multiple risk behavior~     intervention to promote healthy behaviors in people aged between 45 and 75 years attended in~     Primary Health Care services. This intervention aims to reduce tobacco use, to enhance~     adherence to the Mediterranean dietary pattern and to increase physical activity. The study~     also seeks to provide evidence on the strategies to integrate health promotion into the usual~     clinical practice of primary care providers.~   "
32915|NCT03136198|"~     Nearly 80% of acute heart failure (AHF) patients admitted to the hospital are initially~     treated in the emergency department (ED). Once admitted, within 30 days post-discharge, 27%~     of patients are re-hospitalized or die. Attempts to improve outcomes with novel therapies~     have all failed. The evidence for existing AHF therapies are poor: No currently used AHF~     treatment is known to improve outcomes. ED treatment is largely the same today as 40 years~     ago. Congestion, such as difficulty breathing, weight gain, and leg swelling, is the primary~     reason why patients present to the hospital for AHF. Treating congestion is the cornerstone~     of AHF management. Yet half of all AHF patients leave the hospital inadequately decongested.~     The investigators propose a novel approach to aggressively decongest patients in the ED~     setting: lung ultrasound guided, protocol driven, AHF management. LUS B-lines are a measure~     of extra-vascular lung water (EVLW). In the setting of AHF, LUS B-lines are a measure of~     congestion. This simple, easily learned technique has excellent reliability and~     reproducibility. The investigators hypothesize that a strategy-of-care will outperform usual~     care. At the present time, usual care is largely empirical. This study will improve the~     evidence base for ED AHF management. This proposed pilot study, if successful, will lead to~     an outcome trial examining whether an ED AHF strategy-of-care increases days alive and out of~     the hospital for patients.~   "
32916|NCT03136185|"~     This is a Phase 1 open label study of an orally administered LSD1 inhibitor, IMG-7289, in~     patients with myelofibrosis.~      This study investigates the following:~        -  The safety and tolerability of IMG-7289~        -  The pharmacokinetics of IMG-7289~        -  The pharmacodynamic effect of IMG-7289~   "
32917|NCT03136172|"~     To investigate biomarker reflects systemic or specific organ perfusion well, we are going to~     the observational comparison study using several hemodynamic monitoring methods in the~     premature infants. It includes near-infrared spectroscopy (NIRS), pulse oximetry with~     perfusion index (PI) and pleth variability index (PVI) and functional echocardiography.~   "
32918|NCT03136159|"~     Post-cesarean section wound infections are responsible for longer hospital stays,~     readmissions, and ultimately, increased costs to the healthcare system. Silver-containing~     dressings may prevent wound infections. The purpose of the current study is to determine if~     the use of a silver-impregnated dressing decreases the occurence of wound infection following~     cesarean delivery.~   "
32956|NCT03135665|"~     In the scoliosis screening program of the Student Health Service (SHS), Department of Health~     (DH), in Hong Kong, more than 50% of screened school children prescribed with x-ray~     examination basing on the screening protocol did not have Cobb angle greater than the~     referral threshold of 20°; ie they did not need specialist referral and thus were subjected~     to unnecessary x-ray exposure. Our primary objective is to determine whether a new~     radiation-free ultrasound system could identify subjects with Cobb angle greater than the~     referral threshold of 20° thus avoiding unnecessary x-rays in the referral workflow. The~     secondary objective is to evaluate if Angle of Trunk Rotation (ATR) can further increase the~     accuracy of ultrasound assessment.~   "
32957|NCT03135652|"~     This study is a randomized phase II trial to evaluate the efficacy of adjuvant consolidative~     radiotherapy in colorectal cancer liver metastasis (CRLM) patients after chemotherapy~     combined with surgical resection or radiofrequency ablation of liver lesions.~   "
32919|NCT03136146|"~     You are being asked to take part in this study because you have acute lymphoblastic leukemia~     (ALL) or lymphoblastic lymphoma that is relapsed (has come back) or refractory (has not~     responded to treatment)~      This clinical research study has 2 parts: lead-in and Part 2.~      The goal of the safety lead-in portion of this study is to find the highest tolerable dose of~     the combination of clofarabine, etoposide, cyclophosphamide, liposomal vincristine,~     dexamethasone, and bortezomib in patients with relapsed/refractory acute lymphoblastic~     leukemia (ALL) and lymphoblastic lymphoma (LL).~      The goal of Part 2 of this clinical research study is to learn if this drug combination can~     help to control the disease. This will also be studied in the safety lead-in.~      The safety of this drug combination will be studied in both parts of the study.~      This is an investigational study. The chemotherapy drugs used in this study are all FDA~     approved and commercially available for the treatment of certain types of cancer. The~     combination of these drugs is investigational. The study doctor can explain how the study~     drugs are designed to work.~   "
32920|NCT03136133|"~     To investigate the effect of marine peptide combined with dietary protein on the capacity to~     recover after exhaustive endurance cycling as measured by exercise capacity and blood glucose~     homeostasis.~   "
32921|NCT03136120|"~     Interstitial lung disease (ILD) often affects distal lung, and the evaluation of drug~     distribution to the relevant lung compartments is essential for development of new treatment~     options. This single center study will utilize samples obtained by transbronchial cryobiopsy~     (TBCB) procedure to assess the distribution of inhaled drugs in the lungs of the subjects~     with fibrotic lung disease using mass spectrometry techniques. The study will have a single~     visit and will include approximately 20 adult subjects with suspected fibrotic ILD and~     requiring TBCB as part of their diagnostic assessment. This will provide TBCB samples from up~     to 20 subjects, up to 5 of whom may also provide endobronchial forceps biopsy samples. The~     study will have 3 phases including screening to check the eligibility, biopsy phase in which~     all subjects will receive nebulized ipratropium bromide 500 microgram (mcg) for 10 minutes~     immediately before undergoing bronchoscopy and follow up phase from 7 to 14 days after the~     procedure. Drug distribution in the lung will be assessed by analyzing biopsy samples~     collected using mass spectrometry and imaging techniques.~   "
32922|NCT03136107|"~     The purpose of this study is to determine the SPF of the test product according to the~     International Standards Organization (ISO) 24444:2010 methodology (In vivo determination of~     the SPF).~   "
32923|NCT03136094|"~     This study compares the effectiveness of a program to detect and manage suicide risk among~     American-Indian and Alaska Native (AI/AN) youth. Half of the participants will receive caring~     text messages to reduce suicidal thoughts, attempts, and hospitalizations and to increase~     engagement, social connectedness, and resilience in at-risk youth. The other half will~     receive usual care that does not include the caring text messages.~   "
32924|NCT03136081|"~     Septic shock is associated with acquired immunoparalysis which is associated with a high risk~     of nosocomial acquired infection. Nosocomial candidiasis is associated with a 50% rate of~     mortality but is difficult to diagnose. The use of colonization indexes and risk factors on~     the other hand expose to unnecessary use of antifungals. The aim of the present study is to~     evaluate whether the host response to infection associated with candida biomarkers would help~     to anticipate the candidiasis onset.~   "
32925|NCT03136068|"~     This is a research study to measure the effect of digoxin injection on Dilation and~     Evacuation (D&E) procedure duration. Digoxin is the most commonly used feticidal agent among~     family planning subspecialists, and is commonly used for a variety of reasons including~     provider preference, patient preference, and concerns over legal status of later D&E~     procedures. There have been several studies on digoxin administration, adverse effects, and~     impact on the D&E procedure, but doctors want to clarify how digoxin effects D&E procedure~     time, if at all.~   "
32926|NCT03136055|"~     This is a pilot study of pembrolizumab-based therapy in previously treated extrapulmonary~     poorly differentiated neuroendocrine carcinoma~   "
32927|NCT03136042|"~     This study evaluated whether physiotherapy is efficient in sputum induction and in evaluation~     of pulmonary inflammation in asthmatic children.~   "
32928|NCT03136029|"~     Heart disease is the leading cause of death in the United States, accounting for one in every~     four deaths in 2010 and costing over $300 billion annually in health care, medication, and~     lost productivity. Heart failure with a reduced ejection fraction (HFrEF), a clinical~     syndrome that develops as a consequence of heart disease, now affects almost 6 million~     Americans. Within the VA Health Care System, HFrEF hospital admission rates continue to rise,~     and remain the number one reason for discharge from VA hospitals nationwide. Unfortunately,~     over one-third of all Veterans suffering from HFrEF die within two years of discharge despite~     optimized drug therapy, an unacceptably high number. This proposal is focused on how impaired~     muscle blood flow contributes to exercise intolerance in HFrEF, and on subsequently~     developing strategies for restoring exercise tolerance and slowing disease progression in~     this patient group. It is anticipated that knowledge gained from these studies will~     contribute to improved standard of care, quality of life, and prognosis in this VA patient~     group.~   "
32929|NCT03136016|"~     The present study is a randomized school-based trial of a sample of 5th and 6th grade~     students from 10 public schools in the municipality of Duque de Caxias, metropolitan area of~     Rio de Janeiro, Brazil. The aim is to investigate whether adding nudging actions to the~     intervention group of PAAPPAS trial (PAAPAS Study, NCT02711488) increase fruits, vegetables~     and water consumption and daily energy expenditure, in a factorial design.~   "
32930|NCT03136003|"~     Individuals with mild hemophilia A (MHA) bleed infrequently but can in the setting of trauma~     which often is when participating in sports/exercise. Although both exercise and DDAVP~     (desmopressin) can raise Factor 8/Von Willebrand Factor (FVIII/VWF levels), it is not clear~     whether the pathophysiological mechanism is the same. Consequently it is not known if DDAVP~     and exercise would have additive effects in raising FVIII:C and VWF levels or if one would~     one negate the effect of the other. The aim of this 2 center (Sickkids and Columbus, Ohio),~     prospective, cross-over design study is to compare the impact of exercise vs. DDAVP on~     hemostasis in patients with MHA and also to investigate the impact of sequentially~     administering these interventions on their hemostatic indices.~   "
32931|NCT03135990|"~     Anxiety disorders are the most common mental health diagnosis in the US and are associated~     with avoidance that causes functional impairments and decreases quality of life. Social~     anxiety disorder is among the most prevalent anxiety disorders, with most common age of onset~     being in adolescence. The frontline treatment for social anxiety disorder is cognitive~     behavioral therapy with exposure. However, a significant number of adolescent patients do not~     get better after completing cognitive behavioral therapy or experience relapse. This could be~     explained by findings in both mice and humans suggesting that cue-based extinction learning~     occurs less readily in adolescents than in children and adults. Studies using mouse-models~     have overcome this age disparity by enhancing contextual cues when fear extinction learning~     takes place. Providing realistic learning contexts for exposure could be the key to enhancing~     treatment effects in adolescents. This is often challenging for a variety of reasons,~     including difficulty realistically mimicking anxiety-provoking social situations due to~     limited resources, clinician training, time, or motivation. Virtual reality environments~     could provide contextual exposures for social anxiety.~      This pilot study will test the feasibility of integrating virtual reality technology in~     exposure-based treatment in youth ages 13-23 diagnosed with social anxiety disorder with the~     goal of approximating equivalent efficacy with traditional cognitive behavioral therapy, and~     assessing feasibility of virtual reality technology with this population. We will also pilot~     a fear conditioning and extinction learning paradigm to explore the relationship between~     extinction learning and efficacy of virtual reality exposure therapy, using physiological~     assessment indicators to mark changes in fear response. These markers will also be used prior~     to the initiation of the therapy to assess the degree to which virtual reality environments~     invoke a true fear response, comparing the 12 participants with social phobia to 12 age~     matched, non-anxious control participants. The aims of this study are threefold: to assess~     feasibility of using virtual reality in treatment of social anxiety in youth, to examine~     whether virtual reality invokes arousal similar to anxiety and test the physiological~     assessment protocol, and to evaluate whether exposure using virtual reality environments~     reduces symptoms of social anxiety and related functional impairment.~   "
32932|NCT03135977|"~     Although fist-line therapy with Cisplatin and etoposide(EP)or Carboplatin and etoposide(CE)~     has been given, patients with extensive small cell lung cancer(ED-SCLC) still relapse and the~     2-year survival is extremely low. There is no standard maintenance treatment recommendation~     for ED-SCLC patients after the first-line therapy.Apatinib has been approved as a second-line~     treatment for advanced gastric cancer. Several phase III clinical studies of non small cell~     lung cancer, liver cancer, colorectal cancer and other tumors also showed apatinib has less~     toxic side effects and better patient tolerance. However, the clinical application of~     apatinib in small cell lung cancer is still lack of evidence-based medicine,so this clinical~     trial is designed to investigate the efficacy and safety of apatinib combine with etoposide~     as maintenance therapy in ED-SCLC patients after first-line chemotherapy in our center.~   "
32933|NCT03135964|"~     Introduction Negative pressure wound therapy (NPWT), also known as topical negative pressure,~     has become a popular therapy for the treatment of many acute and chronic wounds. In many~     randomized controlled trials(RCTs), NPWT also has benefit in diabetic foot ulcer and pressure~     ulcer. However, most studies used commercial VAC device in combined with polyurethane (PU)~     foam. It is not yet clear where NPWT combined with gauze as wound filler is as effective as~     the PU foam. This RCT evaluated the efficacy of the gauze and PU foam, two kinds of fillers~     routinely used in negative pressure wound therapy, on the healing of the diabetic~     lower-extremity ulcers and the pressure ulcer.~      Methods From 2010/1 to 2015/01, the in-patient persons with difficult to heal diabetic ulcer~     or Grade 4 pressure ulcer were enrolled. These patients were divided into two groups~     randomly. The letter of consent was signed by the patient or patient's family. After~     debridement of the infective wound, the wound of experimental group was packed with a~     moistened Polyhexamethylene biguamide (PHMB) impregnated gauze (Kerlix AMD, Covidien). A~     noncollapsible drainage tube (Blake drain, Ethicon) was applied to the wound, and then sealed~     with 3M Tegaderm Film. The system was connected to a 1-bottle water-seal chest drainage~     system and to standard wall suction at 125 mmHg negative pressure. The dressing was changed~     at 72- to 96-hour intervals (twice a week) for a period of 3 weeks. To the control group, the~     PU foam dressing from KCI was packed and sealed to the wound with the same continuous wall~     suction at -125mmHg. Investigators observed and recorded the ulcer area twice a week on each~     time of changing dressing in the following 3 weeks. The percentage of wound area~     reduction(PWAR) was used as a predictor of wound healing. The repeated measuring data were~     analyzed using linear mixed mode with SPSS statistical software. This clinical study was~     approved and monitored by Institutional Review Board of Show Chwan Memorial Hospital.~   "
32934|NCT03135951|"~     The purpose of this study is to evaluate the pharmacokinetic (PK) profile of a fixed dose of~     SPI-2012 in patients with early-stage breast cancer receiving docetaxel and cyclophosphamide~     (TC) chemotherapy, as measured by the serum concentration of SPI-2012 on specific days~     following drug administration.~   "
32935|NCT03135938|"~     Purpose: To determine the surgical outcomes of the grading versus classic Inferior Oblique~     Anterior Transposition (IOAT) technique in treatment of patients with asymmetric dissociated~     vertical deviation (DVD) and inferior oblique overaction (IOOA).~      Methods: In this randomized clinical trial, a total of 38 patients with IOOA of >+1 and a~     minimum DVD difference of 5pd between their two eyes will be included. Comprehensive~     ophthalmic examinations including visual acuity assessment, measurements of noncyclo- and~     cycloplegic refraction as well as ocular deviation, biomicroscopic and funduscopic evaluation~     will be performed at baseline and repeated three months after the surgery. The function of~     extra ocular muscles will be evaluated by duction and version movements denoting from -4~     (underaction) to +4 (overaction) grades. Also, IOOA will be graded as +1 to +4 according to~     the covering of the cornea under the superior eyelid during the ocular movement towards~     supra-nasal direction. The difference of DVD≥5pd between two eyes will be considered as~     asymmetric DVD. All patients will be randomized in the two groups to undergo IOAT surgical~     procedure; in the classic group, IO muscle will be sutured to the sclera at the level of~     inferior rectus (IR) insertion at its temporal border, without considering the asymmetric DVD~     between the two eyes; while in the grading group, IO muscle of the eye with more severe DVD~     will be sutured at the level of IR insertion and IO muscle of the eye with lower magnitude of~     DVD will be sutured 2mm posterior to the sclera to consider the preoperative DVD difference~     between the two eyes.~   "
32936|NCT03135925|"~     The investigators propose to determine whether it is acceptable to patients with a diagnosis~     of multiple myeloma (a type of blood cancer that can cause bone weakness, pain and fatigue)~     to be offered and attend an exercise group before receiving an autologous stem cell~     transplantation (being given back one's own stem cells, following receipt of intensive~     chemotherapy, to enable bone marrow to start producing blood cells again). Exercise has been~     shown to be effective in reducing many of the side effects of myeloma and the treatment~     patients receive to manage the disease. Prehabilitation i.e. providing an intervention after~     diagnosis but before treatment begins has been effective in reducing the severity of side~     effects of treatment in cancer patients receiving surgery. No evidence exists for its use in~     patients with myeloma. Patients awaiting transplantation will be provided with information~     regarding the study and invited to join. Patients who agree to take part will attend the~     hospital for an assessment of their exercise capability and to complete one set of four~     questionnaires. They will receive an exercise booklet, advice and complete one attempt at~     their exercise programme under supervision of a physiotherapist. Patients will be requested~     to attend the gym for a minimum of six further weeks to complete their exercise programme.~     Patients will complete a repeat set of questionnaires and a repeat walking test six weeks~     after the first, on admission to hospital for their transplant and on the day they leave~     hospital. Some patients will be invited to discuss their opinions of the exercise programme~     and how useful they felt it was to them in preparing for their transplant. If the study shows~     that the exercise programme is acceptable to patients and we can recruit enough patients to~     test it in a larger trial, the investigators will apply for further funding.~   "
33041|NCT03134547|"~     This study was performed to compare the incidence of EA between two dose of sevoflurane for~     sedation with caudal block in children, and intended to find the optimal dose for prevention~     of sevoflurane induced emergence agitation~   "
32939|NCT03135886|"~     This study will test two active evidence-based practice coaching (PC) interventions to~     improve opioid treatment programs' (OTPs') provision and sustained implementation of on-site~     1) HIV testing and linkage to care and 2) joint HIV/Hepatitis C virus (HCV) testing and~     linkage to care among patients seeking/receiving substance use disorder treatment.~      Aims are:~      Aim 1: To evaluate the effectiveness of the PC interventions on improving patient uptake of~     HIV testing in OTPs including the incremental impact of the HIV/HCV intervention on HIV~     testing.~      Aim 2: To examine, using mixed-methods, the impact of the PC interventions on the initiation~     and sustained provision of HIV testing and timely linkage to care.~      Aim 3: To evaluate the health outcomes, health care utilization, and cost-effectiveness of~     the PC interventions compared incrementally to one another and to the control condition.~      Primary Hypothesis:~        1. The two PC interventions will result in significantly higher rates of HIV testing than~          the information control condition in the first period after intervention (initial~          uptake--Primary) and after 12 months of follow-up after initial uptake (sustained~          implementation--Secondary).~        2. The HIV/HCV testing PC intervention will have a significantly higher rate of HIV testing~          in the first period after intervention and after 12 months of follow-up compared with~          the HIV testing only PC intervention (Secondary).~   "
32940|NCT03135873|"~     NAFLD/NASH is one of the most common complications of obesity and diabetes mellitus in~     Western populations affecting approximately 50% of diabetics and 76% of obese patients. Due~     to the lack of specialized treatment, many new efforts focus on exploring alternative,~     non-pharmacologic means for managing the disease, including bioactive substances in fruits,~     vegetables and plants or their products. Mastiha, a natural product of Greece, consists of a~     great variety of bioactive phytochemical compounds and demonstrates antioxidant,~     antiinflammatory, antimicrobial and lipid lowering properties. Taking into account the~     contribution of oxidative stress and inflammation to NAFLD/NASH pathogenesis, the hypothesis~     that Mastiha could improve disease aspects is investigated. Thus, design of a multicenter (4~     centers across Europe), randomized, double-blind, placebo controlled (parallel arm) clinical~     trial to assess the effect of Mastiha on clinical course of NAFLD/NASH patients has been~     conducted. The effectiveness of the proposed intervention will be evaluated via clinical and~     laboratory markers. MAST4HEALTH aims also at exploring gene-diet interactions and at~     correlating genetic and epigenetic markers with metabolomic and intestinal microbiota~     profiles pre- and post- intervention. To this end, patients with confirmed NAFLD/NASH will be~     allocated to either verum or placebo group. Duration of the intervention will be 6 months and~     the dosage applied will be 2.1 g daily. NAFLD/NASH diagnosis will be confirmed by MS scanning~     and the sensitive LiverMultiScan technique. Anthropometric, demographic data, body~     composition, dietary habits, physical activity, family history and smoking status will be~     assessed pre- and post- intervention. Biochemical profile, oxidative stress and inflammation,~     as well as epigenetic and metabolomic profiles will be assessed in blood samples, while the~     metagenome profile will be examined in stools. Both groups will receive counselling to allow~     for body weight regulation up to 5%. Compliance will be assessed monthly and side effects~     will be reported.~   "
32941|NCT03135860|"~     The objective of this exploratory study is to examine the utility of high resolution computed~     tomography (HRCT) to measure changes in functional pulmonary imaging parameters as a function~     of long term iNO administrationusing the device INOpulse for 4 weeks in relation to Patient~     Reported Outcome (PRO) and exercise tolerance in subjects with WHO Group 3 PH associated with~     COPD on LTOT.~      Changes from baseline to 4 weeks of pulsed iNO and after 2 weeks of withdrawal from pulsed~     iNO will be evaluated.~   "
32942|NCT03135847|"~     To assess the functional characteristics and utility of upper and lower limb prosthetic~     devices (advanced bionic and current clinical standard-of-care) that incorporate~     physiologically relevant touch and/or movement feedback.~   "
32943|NCT03135834|"~     This study is examining safety and immunogenicity of 2 doses of Trumenba administered on a~     0-,6- month schedule. This trial is also studyng safety and immunogenicity of a meningococcal~     pentavalent vaccine.~   "
32944|NCT03135821|"~     Irritable bowel syndrome (IBS) is a prevalent condition that adversely affects patient's~     quality of life and represents a large health care burden globally. Currently, there is no~     satisfactory treatment for IBS and Chinese Herbal medicine (CHM) has been suggested to be~     potentially useful. However, the efficacy of CHM in the treatment of IBS is unclear and its~     mechanism of action is unknown. To date, attempts to characterize CHM efficacy universally~     suffer from poor scientific method or they do not faithfully replicate authentic CHM best~     practice. The overall goal of this proposal is hence to address these deficiencies by~     combining the best of CHM with western medicine.The investigators propose a 10-week~     randomized, double-blind, placebo-controlled study on 104 patients that form the intersect~     between western medicine and CHM. The participants would fulfill ROME III criteria for~     IBS-Constipation predominant subtype, which is also the TCM (Traditional Chinese Medicine)~     syndrome of Liver Qi stagnation. The investigators will test a core herbal formula specific~     for treatment of Liver Qi stagnation against placebo that consist of only 10% active~     ingredients but which is indistinguishable by taste from active treatment. Efficacy will be~     assessed by comparing symptoms reported at baseline (2-week run-in period) to end of~     treatment (8 weeks) and an optional follow up period (12 weeks). The primary end point will~     be improvement in IBS-Symptom Severity Score. Mechanism of action will be explored by~     measuring changes to the stool microbiome and GI transit times. If successful, this trial~     would provide one of the first evidence- and mechanism-based approach to translate CHM into~     mainstream IBS management.~   "
32945|NCT03135808|"~     Treatment of rectal cancer has improved to the extent that its local recurrence rates are now~     much lower than other sites in the large bowel. It has been found that higher rates of~     recurrence in the sigmoid section of the colon, just before the rectum. This might be due to~     a narrowing in the bowel, and difficulties identifying whether cancers are in the sigmoid or~     rectum. The aim is to investigate the bowel from 20 patients undergoing surgery for left~     sided colorectal cancer at the Royal Marsden. These patients would have routine~     investigations and treatments, but once the bowel has been removed, it would undergo a MRI~     scan and additional slices and photography during pathological analysis.~   "
32946|NCT03135795|"~     To explore the epigenetic mechanism of postoperative analgesia and side effect induced by~     μ-opioid Receptor Agonists presented with sufentanil among general population.~   "
32947|NCT03135782|"~     This pilot clinical trial studies how well provider training works in increasing patient~     tobacco cessation counseling and referrals for patients with cancer undergoing radiation~     therapy. Health care provider training in motivational interviewing techniques and utilizing~     tobacco cessation resources may help doctors understand how health care providers can~     effectively increase their confidence in talking to patients about tobacco cessation~     counseling.~   "
32948|NCT03135769|"~     Gestational trophoblastic neoplasias (GTN) are characterized by the persistence of elevated~     hCG titers after complete uterine evacuation of a partial hydatidiform mole (PHM) or a~     complete hydatidiform mole. GTN patients are commonly treated with single agent treatment~     (methotrexate or actinomycine-D) or polychemotherapy (first line treatment EMA-CO) according~     to the predicted risk of resistance to single agent treatment by FIGO score. GTN patients~     with resistance to these treatments are treated with another single agent drug or~     polychemotherapy regimens.~      Chemotherapy standard regimens are old and toxic for these young lady patients, with~     potential long term effects detrimental for further maternity and quality of life. There is a~     need for modern targeted agents with better benefit/toxicity profiles.~      There is a strong rational for investigating the anti-PDL1 monoclonal antibody avelumab in~     chemoresistant GTN patients. Several elements suggest that the normal pregnancy immune~     tolerance is hijacked by GTN cell for proliferating :~        -  Spontaneous regressions of metastasic GTN are regularly observed, thereby the role of~          immune system for rejecting GTN cells.~        -  Strong and constant overexpression of PDL1 and NK cells has been found in all subtypes~          and settings of GTN tumors from French reference gestational trophoblastic center.~        -  The case of complete and durable response to pembrolizumab was reported in a patient~          with multi chemo-resistant GTN.~   "
32949|NCT03135756|"~     Eligible participants will come in for three separate visits in which they will be~     interviewed, perform a variety of tasks, and undergo a non-invasive MRI scan. The~     investigators anticipate that (1) participants with anxiety and depression will likely~     perform differently than the healthy controls on cognitive tasks, (2) participants with~     anxiety and depression will likely show differences in brain functionality compared to the~     healthy controls, and (3) depression and anxiety likely share some underlying mechanisms.~   "
32950|NCT03135743|"~     Cancer is the leading cause of death in man and the second leading cause in women with 85,000~     and 63,000 deaths, respectively, in 2012. A working group led by Holly L. Howe, PhD, in 2002~     defined primary neoplasia Such as the occurrence and diagnosis of two or more independent~     neoplasms of different histology in the same patient. The occurrence of a new cancer has~     become more frequent in recent years: the prevalence of multiple primary neoplasia (NPM) is~     estimated between 0.73% and 11.7%. According to the French data, the risk of second cancer in~     people who have already had a first cancer is increased by 36% compared to the general~     population. Several studies have reported an increase in the risk of cancer after treatment~     of lymphoma but there are currently no studies on the occurrence of lymphoma and cancer of~     synchronous occurrence.~      In our department, 19 patients presented cancer and lymphoma synchronously, that is to say 6~     months between 2007 and 2012.~      The main objective is to show that there is an increase in the incidence of cancers in~     patients diagnosed for lymphoma synchronously. Secondary objectives are to describe the~     clinical and biological characteristics of the patients concerned and to formulate hypotheses~     on the physiopathological mechanisms involved: peri-tumoral B-cell lymphoproliferation,~     alteration of the immune system or rearrangement of the BCR.~      In a second step, the investigator could propose a multicenter epidemiological study using~     data from the different Cancer Registries. If results are confirmed in a larger cohort,~     recommendations could be made.~   "
32951|NCT03135730|"~     The Center for Autonomic Medicine in Pediatrics (CAMP) has collaborated with doctors from~     around the world to build the first International ROHHAD (Rapid-onset Obesity with~     Hypothalamic Dysfunction, Hypoventilation and Autonomic Dysregulation) REDCap (Research~     Electronic Data Capture) Registry. This registry is an international collaboration with~     ROHHAD patients and their physicians recruited from around the world.~      The purpose of this IRB-approved research study is to gain a better understanding of the~     various health problems ROHHAD patients face with advancing age, and how these relate to each~     patient's specific medical course. With a better understanding of specific ROHHAD and~     associated clinical manifestations, we will be able to better anticipate healthcare needs and~     to provide more accurate guidelines to healthcare providers world-wide in caring for patients~     with ROHHAD.~      The study aims to obtain detailed phenotypic information (information about health and~     well-being) on patients with ROHHAD. Participation would require filling out a confidential~     survey that asks questions regarding health and past medical history. Involvement in the~     project is completely voluntary and there is no compensation for taking part. However, this~     project will help us learn more about this devastating disease, with the goal of advancing~     treatment.~   "
32952|NCT03135717|"~     Protein energy wasting is an independent factor associated with morbi-mortality in chronic~     kidney disease. Wasting is particularly common in chronic diseases of organs such as kidney~     disease with a major impact at the stage of dialysis. It covers 20 to 70% of patients~     diagnosed with chronic kidney disease according to the degree of evolution of the disease and~     the diagnostic method.~      Mechanisms of PEW are based mainly on anorexia and metabolic abnormalities caused by kidney~     disease. Nutritional treatment differs depending on the stage of the kidney disease acute or~     chronic treated whether or not by dialysis. Nutritional monitoring should be regular,~     individualized and collaborative to detect a risk of PEW or treat installed PEW. Refeeding~     techniques should allow all the nutritional needs. Their indications depend on the clinic,~     biochemical assessment and nutrient intake.~   "
32953|NCT03135704|"~     The objective of this study is to assess the effectiveness of the Re Spine mattress, which~     was designed as an alternative to physiotherapy in the treatment of low back pain (LBP).~   "
32954|NCT03135691|"~     Lung protective ventilation (LPV) has been proposed to reduce the incidence of postoperative~     pulmonary complications (PPCs), and protect against ventilator induced lung injury (VILI).~   "
32955|NCT03135678|"~     The purpose of the OBSERVE PILOT is to verify the feasibility of collecting individual health~     data which is obtained through blood samples, continuous monitoring devices, medical imaging,~     a questionnaire, and a blood pressure monitor.~      Feasibility of collecting individual health data within the OBSERVE PILOT is described as the~     ease of gathering a broad variety of data by assessing: (1) the willingness of the subjects~     to participate in the study, (2) the logistics corresponding with the variety, and (3) the~     regulatory aspects of gathering a broad variety of data.~   "
33301|NCT03131141|"~     This is a single-centre, open-label, non-randomized, single dose study in healthy male~     subjects designed to assess mass balance recovery, metabolite profile and metabolite~     identification of radio-labeled BC-3781 administered via the intravenous or oral routes.~   "
32958|NCT03135639|"~     **Follow-up Control Study for Creativity Study~      Purpose: To investigate the effect of transcranial alternating current stimulation (tACS), a~     form of noninvasive brain stimulation, in healthy subjects. This experiment is a follow-up to~     previous tACS studies that used a creativity assessment.~      Participants: 35 males and females, at least 18 years of age, without history of major~     psychiatric/neurological disease or associated medication use, or prior brain~     surgery/implants.~      Procedures (methods): This is a cross-over study design. Participants will undergo a control~     condition of stimulation (sham or individual alpha, 8-12 Hz, tACS) during~     electroencephalogram recordings. In addition, pupil diameter, heart rate, and respiration~     will be measured continuously. This is to study the physiological effects of stimulation.~   "
32959|NCT03135626|"~     This randomized clinical trial was conducted to examine and compare the effectiveness of~     pulpotomy in primary molars treated with calcium silicate based materials including~     Biodentine and two different mineral trioxide aggregate (MTA) products (white ProRoot® MTA~     and MTA Plus®). Ferric sulfate pulpotomy was selected to represent the control group. 116~     primary molars in 29 children were treated by pulpotomy and followed for a period of 24~     months.~   "
32960|NCT03135613|"~     The aim of this study is to investigate kinematics of knees of patients with tumor around~     knee after microwave ablation with plate internal fixation~   "
32961|NCT03135600|"~     The aim of this study is to investigate the influence of running to kinematic parameters of~     patients with anterior cruciate ligament.~   "
32962|NCT03135587|"~     The aim of this study is to investigate the influence of increasing loading to kinematic~     parameters of normal people while walking on the treadmill.~   "
32963|NCT03135574|"~     Oculomotor nerve (third cranial nerve or III) palsy is a relatively frequent cause of~     consultation in ophthalmology.~      It may reveal a life-threatening pathology such as aneurysm rupture, pituitary apoplexy, and~     therefore need imaging in emergency. Apart from few extreme emergency situations, MRI of the~     oculomotor tract is the first-line examination required. In the usual clinical practice, the~     investigators noticed in several patients unusual areas of high-intensity signal within the~     oculomotor nerve on T2 sequence, observed in various locations along the nerve path~     (cavernous and/ or intra-orbital segment). This abnormal signal, at the best knowledge of the~     investigators, has never been reported in the literature and could confirm the nerve~     impairment.~      In patients with ophthalmoplegia involving probably the third cranial nerve, disclosing this~     new MRI sign could help (i) to confirm the involvement of the oculomotor nerve and eliminate~     differential diagnoses such as myasthenia (ii) to orientate the etiological diagnosis~     (inflammatory or ischemic origin). A T2 sequence focused on the III could thus be~     systematically included in the usual MRI protocol.~   "
32964|NCT03135561|"~     A two-arm parallel randomised controlled trial comparing pedometer-based intervention with~     and without email counselling in a primary care setting. Physically inactive patients from~     four general practices will be randomised to the pedometer-plus-email group or to the~     pedometer-alone group. All patients will be instructed to gradually increase the daily number~     of steps to at least 10,000. Patients in the pedometer-plus-email group will receive 8~     counselling emails based on behavioural techniques. The primary outcome will be change in~     average daily steps measured during 7-day period at baseline and at 12 weeks.~   "
32965|NCT03135548|"~     The primary objective of this trial is to investigate the safety and efficacy of BI 655130 in~     patients with PPP following multiple intravenous administrations compared to placebo.~   "
32966|NCT03135535|"~     Diabetic foot ulceration (DFU) is a common and largely preventable complication. While most~     of these ulcers can be treated successfully, some will persist and become infected.~     Ultimately, nearly one fifth of patients with infected lower-extremity diabetic ulcers will~     require amputation of the affected limb.Prevention by identifying people at higher risk is~     the key for better clinical management of such patients. It is not uncommon for patients~     suffering from diabetes to have concomitant lower extremity edema or even venous~     insufficiency and they subsequently may benefit from graduated compression. However, because~     of the common association of peripheral arterial disease (PAD) in patients with diabetes,~     most clinicians are reluctant to apply compressive dressings in fear of exacerbating the~     symptoms of PAD and the possible resulting gangrene.~      A novel micro-mobile foot compression device named Footbeat (AVEX, Inc.) offers alternative~     means providing lower extremity compression. This device is portable and can be used in a~     standard diabetic shoes on daily basis, which in turn may improve venous blood and relief~     from concomitant lower extremity edema. In addition, potential improvement in lower extremity~     blood flow in response to regular foot compression, could improve balance, gait, skin~     perfusion, plantar sensation, and overall daily physical activities (e.g. number of taken~     steps per day, duration of standing, etc).~      The purpose of this study is to conduct an observational study with N=30 ambulatory patients~     with diabetes and loss of protective sensation to assess whether this micro-mobile foot~     compression device can help improving motor function, lower extremity perfusion, and vascular~     health.~   "
32967|NCT03135522|"~     The Pilot of Zinc Acetate to Improve Chronic Cough (ZICO) is a study of 36 patients with~     chronic refractory cough that will be used to (1) assess if zinc acetate (150 mg/day) will~     improve patient reported measures of cough, (2) to establish if treatment with zinc acetate~     is well tolerated, and (3) to determine if the trial logistics are feasible.~   "
32968|NCT03135509|"~     This is an open-label, randomized, 2-period, 2-way crossover study to assess the relative~     bioavailability of a new CC-220 capsule formulation, compared to a reference CC-220 capsule~     formulation, after administration of single oral doses in healthy adult subjects under fasted~     conditions.~      Approximately 16 subjects will be assigned randomly to 1 of 2 treatment sequences. The~     sequences will dictate the order in which each subject receives the following treatments:~        -  Treatment A (Reference): A single dose of 0.6 mg CC-220, administered as two 0.3-mg~          formulated CC-220 gelatin capsules.~        -  Treatment B (Test): A single dose of 0.6 mg CC-220, administered as one 0.6-mg~          formulated CC-220 Hydroxypropyl methylcellulose (HPMC) capsule.~   "
33042|NCT03134534|"~     Robot-assisted thoracoscopic surgery (RATS) was widely used in thoracic surgery, the surgical~     safety and feasibility of RATS lobectomy for NSCLC has been confirmed. However, the~     oncological long-term outcomes of RATS lobectomy has not been studied by randomized~     controlled trial, the purpose of this study is to determine whether RATS lobectomy would be~     as effective as VATS lobectomy on short-term and long-term outcomes.~   "
32969|NCT03135496|"~     Patients with aortic stenosis present many risk factors for endothelial dysfunction (arterial~     hypertension, arteriosclerosis, dyslipidemia, chronic renal insufficiency, etc.). It is~     likely that a significant number of patients suffer from pre-existing endothelial dysfunction~     that can be evaluated by a molecular approach.~      To date, the replacement of the aortic valve can be performed by surgery with extracorporeal~     circulation (CEC) or percutaneous (Transcatheter Aortic Valve ImplantationTAVI) without CEC.~      Two recent studies have demonstrated a sustained improvement in endothelial function with~     TAVI. On the contrary, studies have demonstrated that post-operative complications~     (coagulopathy, capillary leak syndrome, acute vasoplastic disorder and acute renal failure)~     after surgery with extracorporeal circulation (CEC) could be the result of the interaction~     between pre-existing endothelial dysfunction And the operative aggression associated with~     the CEC.~      Thus, patients with preexisting involvement of endothelial function would develop vascular~     dysfunction after valvular replacement due to endothelial activation related to CEC. This~     phenomenon would not exist in TAVI, and would explain the absence of so-called vascular~     dysfunction complications (Systemic inflammatory response syndrome, vasoplastic syndrome,~     disseminated intravascular coagulation).~   "
32970|NCT03135483|"~     Acute kidney injury (AKI) affects approximately 20% of hospitalized patients and up to 67% of~     those admitted to an intensive care unit (ICU), making it among the most common organ~     dysfunctions among the critically ill.Major adverse cardiac events (MACE) after non cardiac~     surgery are a leading cause of morbidity and mortality. The reported incidence of~     postoperative myocardial infarction (POMI) among patients undergoing noncardiac surgery is~     between 3% and 6%.The aim of this study is to Identify the impact of acute kidney injury on~     the development of myocardial injury after non cardiac surgery and to correlate it with other~     risk factors of for MINS.~   "
32971|NCT03135470|"~     In Finland, there are no guidelines concerning post-operative pain medication of ambulatory~     surgery patients. There is a wide variety in drug prescription and medication practices of~     various doctors and clinics. To treat patients' pain safely, type of surgery, unique patient~     needs, risks, adverse effects and patient's capacity to follow instructions should be~     assessed during the few hour visit at the clinic. In many clinics, pain is treated after~     hospital discharge with strong opioid oxycodone, but the amount and dose of prescribed~     oxycodone varies. In Helsinki Universitys Hospital, Peijas Hospital, investigators have over~     2000 ambulatory surgery procedures annually. Investigators have strict policy in oxycodone~     use after patient discharge compared to some other Finnish ambulatory surgery clinics. The~     aim of this study is to evaluate, whether the prescribed pain medication is sufficient and~     whether patients' suffer from adverse effects after discharge from ambulatory surgery (letter~     interview). The study proceeds in three phases: 1) observation of current medication~     practice, 2) observation after optimization and standardization of hospitals drug~     prescription protocol, 3) evaluation of mobile phone app in pain medication follow up.~   "
32972|NCT03135457|"~     This is an open-label, prospective crossover randomized controlled trial to investigate~     wether TACO is solely hydrostatic pressure overload or arises from a combination of~     hydrostatic pressure overload and capillary leakage, by investigating the difference in~     change in static pressure parameters (PCWP), dynamic volume parameters (PICCO) as indirect~     measurements of volume status and capillary leakage after autologous transfusion or saline~     infusion. The investigators will estimate effective circulating volume following autologous~     transfusion or saline infusion. Furthermore, the investigators will investigate the effect of~     fluid loading on the microcirculation.~   "
32973|NCT03135444|"~     The study team created a tool to help identify patients who may benefit from shared decision~     making in the primary care setting. This tool is a guide to aid in decision making for~     prostate cancer screening. The team proposes the topics to be discussed in the screening~     conversation include the risk for developing prostate cancer based upon age, race/ethnicity,~     family history of prostate cancer, history of previous digital rectal exam, and history of~     previous prostate specific antigen (PSA) as well as self-reported health status and~     preferences for treatment. The team now proposes 1) testing this tool first for ease of use~     in primary care clinics 2) revising this tool based upon feedback from patients and~     providers, then 3) testing this tool for effectiveness in improving patient knowledge that~     they have an option to be screened for prostate cancer and of specific factors to be~     considered in the screening decision.~   "
32974|NCT03135431|"~     The purpose of this study is to compare the safety of performing a bilateral tubal ligation~     vs. bilateral salpingectomy, two procedures performed for permanent sterilization, at the~     time of cesarean delivery. The investigators want to determine if performing bilateral~     salpingectomy at the time of cesarean delivery poses any greater risk for blood loss, as~     compared to a bilateral tubal ligation.~   "
32975|NCT03135418|"~     In this study we aimed to determine whether the additional rehabilitation with 3D virtual~     reality headsets provide any functional contribution to conventional rehabilitation~     techniques of upper extremity in patient with stroke.~      Forty patients with stroke history no more than 2 years will be included in this study.~     Patients will randomly be divided into 2 groups as control and intervention. Conventional~     rehabilitation techniques will be applied for 4 weeks in both groups. Intervention group will~     receive a 3D virtual reality rehabilitation training, each lasts 45 minutes, with a special~     headset 3 times a week for 4 weeks in addition to conventional rehabilitation. Patients will~     be assessed with Fugl-Meyer, Action Research Arm Test and Functional Independence Measurement~     at baseline and 4 weeks after first assessment. It will be evaluated that whether 3d virtual~     reality rehabilitation training provides any benefit to stroke rehabilitation.~   "
32976|NCT03135405|"~     The study evaluates the use of automated motivational messages, visit reminders, and~     medication reminders (using interactive voice response technology or text messages) to~     improve blood pressure control among adults with hypertension that receive their care at the~     First Nations Community Healthsource clinic in Albuquerque, New Mexico. Half of the~     participants will receive usual care, while the other half will receive the automated calls~     or text messages and have the option to receive home blood pressure monitors and/or designate~     a care partner who will also receive messages. Participants will be followed for 12 months.~   "
33302|NCT03131128|"~     The present study will carry out a workplace health promotion via MBI with lessons of dietary~     behavior to help overweight or obese workers to loss weight.~   "
32977|NCT03135392|"~     Tissue Expander/Implant Reconstruction: The purpose of this study is to determine how and~     when nerve sensation to the breast skin returns after mastectomy.~      Autologous Tissue Reconstruction: The purpose of this study is to determine whether the~     tissue being used to reconstruct your breast can provide sensation by using your own nerves.~     Typically all sensation is lost immediately after this type of surgery and returns to varying~     degrees. We are hoping to demonstrate that by connecting the two nerves (one from abdomen and~     one from the chest wall) together, we can attain meaningful sensation in the transferred~     tissues thereby improving your quality of life following surgery.~   "
32978|NCT03135379|"~     The purpose of this single-blind, randomized control trial will be to investigate whether~     simply having warmed gel, as compared to room-temperature gel, during a bedside ultrasound~     significantly improves patient satisfaction scores.~   "
32979|NCT03135366|"~     Each year, 10.4 million patients are diagnosed with and 1.8 million people die from~     Tuberculosis (TB). Despite the availability of highly effective and accessible medications in~     the developing world where TB is endemic, the 6-18 month treatment regimen is often thwarted~     as patients fail to comply due to a lack of knowledge about the disease, desire for privacy,~     and/or stigma avoidance. Inappropriate medication use leading to multi-drug resistant (MDR)~     TB infects 5% of all TB patients, yet accounts for a significant proportion of all spending.~     In Kenya, the burden of TB is among the highest in the world with a prevalence rate of 558~     cases per 100,000 people. There is a great need for the development of alternative protocols,~     which reduce the costs of treatment and burden of adherence, and more effectively motivate~     patients to adhere to the program. A substantial and growing literature in the social~     sciences demonstrates the potential of behavioral interventions for generating large~     increases in contributions to public goods.~      This 1200 participant, Randomized Controlled Trial (RCT) explores the capacity of Keheala, a~     feature-phone and Internet-based digital platform that uses Unstructured Supplementary~     Service Data (USSD) technology, to deliver behavioral interventions for improving treatment~     adherence, outcomes and quality of life for TB patients in Nairobi, Kenya. Keheala taps into~     this underutilized potential by developing a powerful, cost-effective platform for better~     engaging patients' sense of responsibility to their community in order to increase adherence.~   "
32980|NCT03135353|"~     comparing the efficacy of the 3D saline infusion sonohysterography to the diagnostic office~     hysteroscopy in the diagnosis of the cause of abnormal uterine bleeding in females during~     their reproductive age~   "
32981|NCT03135340|"~     Wide-awake hand surgery with local anesthetic, no tourniquet and no sedation (WALANT) is~     increasingly utilized. Conventional anesthesia for hand surgery involves a patient with a~     block, unable to perform motor function in the arm, and with patient either intubated or~     sedated, unable to follow surgeon instructions intra-operatively. Flexor tendon repair with a~     wide awake and cooperative patient is routinely performed successfully at some centres. This~     method provides several potential benefits including being able to have the patient actively~     flex the digit and visualize the repair site to assess for any tendon gapping at the repair~     site, ensure adequate approximation, gliding and absence of triggering. There have not been~     any prospectively collected randomized controlled trials comparing wide awake vs.~     regional/general anesthesia in flexor tendon repair. The purpose of our study is to assess~     for differences in early outcomes including stiffness, patient satisfaction and early~     complications in wide-awake anesthesia when compared to general/regional anesthesia for~     flexor tendon repair in zones I and II. Our hypothesis is that there is a lower complication~     rate and better outcomes when using wide-awake flexor tendon repair.~   "
32982|NCT03135327|"~     This study to determine the clinical application of advanced ophthalmic imaging devices such~     as optical coherence tomography (OCT), retinal function imager (RFI), slit-lamp biomicroscopy~     (SLB), PERG in diseased eyes and normal controls.~   "
32983|NCT03135314|"~     Not uncommonly, sports events take place or finish at high altitude, where physical and~     cognitive (e.g. decision-making, motor control) performance in hypoxia is determining the~     outcome of sports performance. With nutritional supplements growing in popularity in the~     athletic and non-athletic population, research is increasingly focussing on dietary~     constituents which can improve cognitive and exercise performance.~      Flavonoids, a subgroup of polyphenols, are a class of natural compounds found in the human~     diet and include subcategories of flavanols, flavonols, iso-flavones, flavones, and~     anthocyanidins. Intake of flavanols, found in grapes, tea, red wine, apples and especially~     cocoa, causes an nitric oxide (NO)-mediated vasodilatation and can improve peripheral and~     cerebral blood flow (CBF).~      For cocoa flavanol (CF), there is evidence that both long term and acute intake can improve~     cognitive function, with the quantity and bioavailability of the consumed CF highly~     influencing its beneficial effects and with higher doses eliciting greater effects on~     cognition. Increased CBF following acute and chronic (3 months) CF intake has been~     demonstrated in healthy young subjects. Moreover, cognitive performance and mood during~     sustained mental efforts are improved after acute CF intake in healthy subjects and CF intake~     can increase prefrontal oxygenation during cognitive tasks in well-trained athletes.~     Moreover, CF intake is not only associated with an improved blood flow, but it might also~     improve exercise performance following 2 weeks of dark chocolate intake. On top of that, CF~     is known to have anti-oxidant properties and 2 week CF intake has been associated with~     reduced oxidative-stress markers following exercise.~      In hypoxic conditions, arterial pressure of oxygen (PaO2) and arterial saturation of O2~     (SaO2) are decreased, compromising tissue oxygen delivery. Since brain function and brain~     integrity are dependent on continuous oxygen supply, brain desaturation may result in an~     impaired cognitive function in hypoxia. The severity of the impairment is related to the~     extent of high altitude, with at 3000m (=14.3 % oxygen (O2); = 71% of oxygen available at sea~     level) psychomotor impairments being visible. Cerebral oxygenation, which can be measured by~     Near-infrared spectroscopy, is lowered in hypoxia.~      It remains unclear whether CF intake can influence cerebral oxygenation and perfusion in~     hypoxic conditions and whether CF intake could (partially) counteract hypoxia-induced~     cognitive impairments. Therefore, the first aim of this study was to investigate whether~     cognitive function and prefrontal oxygenation during a mental demanding task will be impaired~     by hypoxic conditions (3000m altitude; 14.3% O2) and whether these impairments can be~     partially restored by subchronic CF intake (7 days, 900 mg/day).~      Hypoxia also impairs physical performance. Hypoxia-induced reductions in cerebral oxygenation~     may favour central fatigue, i.e. the failure of the central nervous system to excite the~     motoneurons adequately, hence impairing exercise performance in hypoxic conditions. Since~     hypoxia also impairs oxygen delivery to muscle tissue, the decreased oxygen supply to and~     impaired oxidative energy production in the exercising muscle is a second factor negatively~     affecting exercise performance.~      Besides the aforementioned effects of altitude on O2 delivery, hypoxia also results in~     increased oxidative stress. Oxidative stress refers to the imbalance between prooxidant and~     antioxidant levels in favor of prooxidants in cells and tissues and can result from~     diminished antioxidant levels or increased production of reactive oxygen species. The latter~     can be induced by both exhaustive exercise and high altitude. Since oxidative stress can be~     counteracted by CF, we also aim to investigate how markers of oxidative stress can be~     affected by CF intake by exercise in hypoxia. Therefore, the second aim of this study was to~     investigate possible beneficial effects of CF intake on changes in cerebral and muscle~     vasoreactivity and oxidative stress during exercise in hypoxia and its implications on~     exercise performance.~   "
32984|NCT03135301|"~     Polycystic ovary syndrome accounts for the vast majority of anovulatory symptoms and~     hyperandrogenism in women. The diagnosis of Polycystic ovary syndrome has life-long~     implications, with increased risk for infertility, metabolic syndrome, and type 2 diabetes~     mellitus, and possibly for cardiovascular disease and endometrial carcinoma. Polycystic ovary~     syndrome is diagnosed in adolescents with otherwise unexplained, persistent hyperandrogenic~     anovulatory symptoms that are inappropriate for age and stage of adolescence. It should be~     considered in any adolescent girl with a chief complaint of hirsutism, treatment-resistant~     acne, menstrual irregularity, acanthosis nigricans, and/or obesity~   "
32985|NCT03135288|"~     Unintended and closely spaced pregnancies are a major public health problem that affects not~     only the individuals directly involved but also the society indirectly. It increases the~     risks of infants with adverse outcomes such as preterm, low birth weight and small for~     gestational age. Pregnancy occurring within six months of the last delivery holds a 7.5-fold~     increased risk for induced abortion, a 3.3-fold increase in miscarriage and a 1.6-fold~     increased risk of stillbirth. But, use of contraceptive methods has been shown to reduce~     unwanted pregnancy, high fertility and maternal mortality rates.~   "
32986|NCT03135275|"~     The primary objective of the trial is to compare, in patients presenting with ST elevation~     myocardial infarction (STEMI) and multi-vessel disease (MVD), the safety and efficacy of~     immediate complete primary percutaneous coronary intervention (PCI) of all target vessels~     versus culprit vessel only revascularization, followed by staged PCI (within minimal 19 and~     maximal 45 days) of all target vessels, in a non-inferiority trial, using a third generation~     biodegradable-polymer everolimus-eluting stent (Synergy™).~   "
32987|NCT03135262|"~     This Phase Ib/II, open-label, multicenter, non-randomized, dose-escalation study will~     evaluate the safety, efficacy, and pharmacokinetics of obinutuzumab in combination with~     idasanutlin and venetoclax in participants with R/R FL and obinutuzumab or rituximab in~     combination with idasanutlin and venetoclax in participants with R/R DLBCL. The study will~     include an initial dose-escalation phase followed by an expansion phase. The dose-escalation~     phase is designed to determine the recommended phase II doses (RP2Ds) and regimen for~     idasanutlin and venetoclax in combination with obinutuzumab for FL participants and in~     combination with rituximab for DLBCL participants.~   "
32988|NCT03135249|"~     The purpose of this study is to determine if a sequential combination therapy of natalizumab~     and alemtuzumab induces peripheral tolerance and reduces the annualized relapse rate (ARR) in~     patients with relapsing-remitting multiple sclerosis (RRMS).~   "
32989|NCT03135236|"~     By integrating sexuality and disability literatures, theories, and research methodologies,~     this study aims to: 1) contribute to the limited knowledge professionals have of parents as~     the primary sexuality educators; 2) create a resource for parents in order to be sexuality~     educators for their young adults with I/DD; and 3) evaluate the effectiveness of the Home~     B.A.S.E. for Developmental Disabilities Curriculum.~      In order to meet the objectives the study seeks to answer the following questions:~        1. What is the effectiveness of a sexuality education workshop for parents of young adults~          with DS on improving the self-efficacy and attitudes around sexuality and healthy~          relationships for young adults with DS as well as increase the parent-child~          communication on sexuality topics?~        2. What are parents' concerns that impact their ability to be the primary sexuality~          educators for their young adults with DS? It is proposed that parent confidence and~          comfort talking about sexuality topics with their young adult with Down syndrome will~          increase thereby increasing the parent-child communication as a result of this study.~   "
32990|NCT03135223|"~     Secondary schoolgirls have the most unhealthy profile regarding physical activity and~     sedentary behaviour of all age groups. Since both behaviours independently contribute to~     various health outcomes, an effective intervention to promote physical activity and to reduce~     sedentary behaviour needs to be developed.~      Many interventions fail to induce changes in health behaviour, as they often use a top-down~     approach with limited input from the end-users (i.e. the secondary schoolgirls) of the~     intervention programmes. This project uses a participatory health research approach by~     actively involving the girls in the entire research process. A co-creation group was set up~     per intervention school (n=3), including girls and a researcher which co-created a~     school-specific intervention, tailored to the needs and interests of those girls.~      The effect of participatory process were evaluated via a clustered randomized controlled~     trial using an intervention and control condition and a pre- and post-test design. Effects on~     physical activity and related determinants (e.g. self-efficacy, attitude, etcetera) were~     evaluated. The hypothesis was that girls from the intervention condition would improve their~     physical activity levels and related determinants compared to no changes among girls from the~     control schools. The process was evaluated as well using focus group research and the~     hypothesis was that girls who participate in the co-creation groups would be positive about~     the process and will feel empowered.~   "
32991|NCT03135210|"~     The primary aim of this study is to assess the functional impact of leg exercise during the~     pre-ambulation phase in patients undergoing ECMO. Outcome measures will be categorized as~     either functional or hospital based. Hospital measures include: Hospital days, intensive care~     unit days, days on ECMO, days on mechanical ventilation, length of time from physical therapy~     evaluation to initial ambulation, and discharge disposition. Functional outcome measures~     include: Leg strength, grip strength, 30-second sit to stand test, Functional Status Score~     for the Intensive Care Unit (FSS-ICU), and the Richmond Agitation and Sedation Scale (RASS).~   "
32992|NCT03135197|"~     The objective of the study is to document long term data on treatment with Migalastat under~     real world conditions. The selection of patients is based on the SmPC/Fachinformation. The~     study duration/patient will be 2 years.~   "
32993|NCT03135184|"~     Assess the effect on coronary atheroma of serial infusions of autologous selectively~     delipidated HDL/preβ enriched plasma following use of HDL Therapeutics PDS-2™ System~   "
32994|NCT03135171|"~     The goal in this Phase 1 dose-escalation trial of the anti-IL-6R monoclonal antibody~     tocilizumab in combination with trastuzumab and pertuzumab in subjects with metastatic HER2~     positive breast cancer is to determine the safety, tolerability and recommended Phase 2 dose~     of tocilizumab given with trastuzumab and pertuzumab every 3 weeks.~   "
32995|NCT03135158|"~     The present study aims to determine the relationship between postpartum changes in the shock~     index and the severity of blood loss and other PPH results. Blood loss, heart rate and blood~     pressure will be systematically measured in the postpartum period in all participating women~     to explore new clinical indicators to identify those requiring clinical intervention for~     excessive bleeding.~   "
32996|NCT03135145|"~     Lite Run is a new assistive device that may have FDA listing as a Class I device by mid 2017~     based on clinical testing of adults, independent agency testing and in-house evaluations.~      This will be a combined study with multiple purposes with respect to the evaluation of its~     use with the post-operative pediatric population. A first purpose is to verify safety and~     feasibility of the device on pediatric patients. A second purpose is to statistically test~     the effectiveness of Lite Run to decrease physical burden on the therapist during~     post-operative gait training for children and adolescents with cerebral palsy as compared to~     current methods of body weight-supported gait training. A third purpose is to measure and~     qualitatively evaluate the effectiveness of the device on patient outcomes and improving~     patient and therapist satisfaction.~   "
32997|NCT03135132|"~     To determine whether low calorie diet (LCD)-induced weight reduction caused changes in plasma~     metabolites and metabolic traits from baseline.~   "
32998|NCT03135119|"~     This study will examine the incremental benefit of animal-assisted therapy (AAT) as an~     adjunct intervention when combined with Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT)~     for the treatment of maltreated youth. In addition, the development of therapeutic rapport~     and the intensity of stress experienced during treatment sessions will be examined as~     mediational mechanisms of treatment outcome. This project will help determine whether a~     larger study to test the beneficial effects of AAT for maltreated youth is feasible and~     warranted.~   "
32999|NCT03135106|"~     The purpose of this study is to evaluate the effect of multiple doses of fluconazole (an~     inhibitor of cytochrome P450 [CYP] 2C9 and CYP3A) and itraconazole (an inhibitor of CYP3A4~     and P-glycoprotein [P-gp]) on the pharmacokinetics of a single 4-milligram (mg) oral dose of~     erdafitinib in healthy adult participants.~   "
33000|NCT03135093|"~     This project is a cross-sectional, observational mono-center study with prospective data~     collecting.~      This study aims to further explore quality of upper limb movement in relation to~     characteristics of visuospatial exploration in stroke subjects and healthy subjects by a~     applying comprehensive measurements of clinical scales and kinematic data in capacity- and~     performance-based activities. The results will contribute to assessing and monitoring quality~     of upper limb movements and visuospatial attention and their relationship.~   "
33001|NCT03135080|"~     The research group developed a surgical simulation device, the Human Eyelid Analogue Device~     for Surgical Training And skill Reinforcement in Trachoma (HEAD START), to bridge the gap~     between classroom and live-surgery training specifically for trichiasis surgery. In most~     settings, HEAD START is utilized once during training, then surgeons move on to live surgery~     and typically do not return to the simulator. The research team is interested in determining~     whether HEAD START provides benefit for long-term trichiasis surgery training, since many~     surgeons operate seasonally, with long periods of downtime between surgical camps and with~     little field supervision.~      Participating surgeons will practice on HEAD START weekly, with monthly feedback from a~     senior supervisor. Researchers will assess their skill level at the start of HEAD START~     training and again at the start of the new surgical season in the fall of 2017. Researchers~     will also administer questionnaires to elicit feedback on the HEAD START training and~     supervision process.~   "
33002|NCT03135067|"~     This cluster randomized trial will assess whether the provision of multiple oral-fluid based~     HIV self-test kits to HIV-negative women at high risk of acquiring HIV in western Kenya is an~     approach that promotes HIV testing among women's sexual partners, facilitates better sexual~     decision making, and reduces women's risk of acquiring HIV.~   "
33003|NCT03135054|"~     The study aims to test if combination of quizartinib (AC220) and omacetaxine mepesuccinate~     (OM, also known as homoharringtonine) results in durable composite complete remission (CRc)~     in patients with newly diagnosed or relapsed/refractory (R/R) acute myeloid leukemia (AML)~     carrying FLT3-ITD (Fms-Like Tyrosine Kinase 3 - Internal Tandem Duplication).~   "
33004|NCT03135041|"~     The aim of this study is to investigate whether a diet supplemented with two prebiotic fibres~     induces greater changes in body weight compared to placebo during 12 weeks of energy~     restriction in an obese/overweight population.~      The hypothesis is that the fiber-containing dietary supplement will:~      1) Induce greater changes in body weight compared to the placebo group 2) change the gut~     microbiota composition 3) improve glucose homeostasis 4) decrease serum concentration of~     triglycerides, total and LDL cholesterol~      The hypothesis is that the effect of the intervention on weight loss will be partly mediated~     by the diet-induced changes in the gut microbiota composition.~   "
33005|NCT03135028|"~     The primary objective of this study is to evaluate the safety and tolerability of~     Entospletinib (ENTO) monotherapy and in combination with chemotherapy in Japanese~     participants~   "
33006|NCT03135015|"~     Blood sugar levels are controlled by insulin, a hormone made by cells in the pancreas. After~     a normal meal, carbohydrates are broken down into glucose (blood sugar) which is absorbed~     from the intestine into the blood leading to a rise in blood glucose which triggers the~     secretion of insulin. Insulin binds to cells in the liver, muscle and fat, triggering them to~     take up glucose and bring the blood glucose level back to normal.~      A high blood sugar level is known as diabetes. The most common form of diabetes, type 2~     diabetes, is caused by insulin resistance; that is, a reduced ability of insulin to stimulate~     glucose uptake into cells. The body compensates for insulin resistance by making more~     insulin; type 2 diabetes occurs when the pancreas can no longer make enough insulin to~     control blood glucose. The high blood glucose and insulin levels lead to long-term~     complications such as heart attacks, kidney failure, reduced sensation and poor circulation~     in the feet and legs. Reducing blood glucose levels with oral medications and insulin reduces~     risk of diabetes complications. There are several types of oral medications available for~     treating diabetes; however, they do not always control blood glucose adequately. In addition,~     these drugs have complications and are not used to treat insulin resistance and pre-diabetes;~     a condition when blood glucose is higher than normal but not high enough to be called~     diabetes. Pre-diabetes often progresses to diabetes over a period months or years. Effective~     and safe treatments for pre-diabetes could prevent or delay the onset of diabetes.~      Axulin is a natural health product consisting of a mixture of extracts from herbs and~     vegetables present in normal diets which has been shown in cell-culture (cells grown in the~     laboratory) and in animal studies to increase the ability of insulin to stimulate glucose~     uptake into cells. Thus, Axulin may reduce the blood glucose and insulin levels of subjects~     without diabetes after eating. Also Axulin may reduce glucose and insulin responses more in~     insulin-resistant compared to insulin-sensitive subjects.~      Subjects will take 0g, 2g or 4g or Axulin capsules or Axulin tablets in the morning after an~     overnight fast; 40min later they will then consume 75g glucose dissolved in 300ml water.~     Blood glucose, insulin and fats will be measured before and for 2 hours after the glucose~     drink.~   "
33007|NCT03135002|"~     Chronic kidney disease (CKD) is estimated to affect 6-8% of the adult population and is~     independently associated with increased cardiovascular (CV) disease risk. This risk increases~     as CKD advances both in relation to worsening glomerular filtration rate and development of~     proteinuria. The overall cost of CKD to the NHS in England has been estimated as £1.45~     billion per annum, or 1.3% of the NHS's total budget. This includes £175 million, or 13% of~     the CKD budget, annually spent in relation to 19,000 excess myocardial infarctions and~     strokes related to CKD.~      The epidemiology of CKD in primary care is poorly studied. This is particularly the case in~     non-white populations who have an independent higher risk of progression to end stage renal~     failure (requiring dialysis or transplantation), CV events and death.~      Further, CV disease risk in CKD remains poorly described beyond simple risk stratification by~     CKD stage. A recent systematic review identified some CKD-specific CV disease risk scores.~     However, all the risk scores had significant methodological limitations, such as a lack of~     external validation or the perception that they were not 'clinically useful'. The Leicester~     City and County Chronic Kidney Disease (LCC-CKD) cohort will be created from anonymised GP~     records of individuals with CKD. We will aim to retrospectively create a cohort with 5 years~     follow-up to the present day. In addition, a present day cohort will be created to both aid~     research and provide data for practices and clinical commissioning groups for quality~     improvement (QI) purposes. We will aim to include 30,000 individuals with CKD in the cohort.~      The principal objectives of the study are:~        1. To study the natural history of CKD in a multi-ethnic primary care setting~        2. To contribute to the creation of a risk prediction tool for heart attacks and strokes in~          CKD~      The risk prediction tool would more accurately stratify risk of CV events for individuals~     with CKD. This would aid patients and clinicians in deciding on treatments aimed at reducing~     the risk of future myocardial infarctions and strokes. Currently, individuals with CKD,~     despite higher risk of CV disease, may not be receiving optimum treatment such as statins and~     anti-hypertensive medications. Improved management of cardiovascular risk factors in CKD is~     likely to see a reduction in CKD associated excess CV events and their associated costs,~     including longer average duration of inpatient admissions.~   "
33008|NCT03134976|"~     This is a prospective observational study evaluating wound complications following head and~     neck surgery. Patients undergoing major head and neck surgery will be included in the study.~     Patients meeting eligibility criteria will be identified by members of the University of~     Michigan Head and Neck Oncology Division of the Department of Otolaryngology. The primary aim~     of this study is to identify risk factors for poor wound healing as well as biologic markers~     associated with wound related complications in head and neck surgery. Most specifically, this~     study evaluates the effects of thyroid hormone on wound healing. This study will also~     evaluate pre-operative labs and comorbidities as well as reconstructive factors,~     post-operative labs, and other variables associated with wound healing. All interventions~     regarding wound healing fall under current standards of care and standard practice. Data~     regarding post-operative wound complications will be collected in a prospective fashion on~     the variables under study using study-specific datasheets. Data sheet will be entered into a~     secure database for analysis.~   "
33161|NCT03132987|"~     Quantify differences in quadriceps function and gait biomechanics in individuals within 2~     years of ACL reconstruction compared to a healthy comparison group and establish the~     feasibility of conducting a progressive strengthening program to improve clinical and~     patient-oriented outcomes in individuals who are within 2 years of ACL reconstruction~   "
33009|NCT03134963|"~     850,000 people live with dementia in the UK, with that number expected to rise to more than 1~     million within the next 5 years. The most common type of dementia (55%) is Alzheimer's~     dementia, and vascular dementia is the second commonest type (15%). Mild cognitive impairment~     (MCI) affects up to 20% of older adults and describes a set of symptoms rather than a~     specific medical condition or disease. A person with MCI has subtle problems with one or more~     of the following: day-to-day memory, concentrating, planning or organising, language (eg~     struggling to find the right word), and judging distances and seeing objects properly.~     Although MCI significantly increases the risk of developing dementia (by up to 5 times), at~     present it is not possible to accurately predict which patients with MCI will progress to~     dementia. In recent times there has been an increasing awareness that problems with brain~     blood flow may contribute to the development, or progression, of dementia. Tests of mental~     abilities, with standardised questions and pen-and-paper tests are a key component of the~     formal diagnosis of dementia, yet little is known of the effects of these tests on brain~     blood flow. Brain blood flow can be can be assessed non-invasively by the use of Trans~     Cranial Doppler (TCD). This means using ultrasound probes over both sides of the head to~     measure changes in blood flow in one of the main brain arteries (the middle cerebral artery).~     This proposed study will therefore use TCD to evaluate changes in brain blood flow during~     performance of the Addenbrooke's-III (ACE-III) cognitive assessment in four key groups of~     patients, specifically:~        1. Healthy older adults~        2. Patients with mild cognitive impairment (MCI)~        3. Patients with vascular dementia~        4. Patients with Alzheimer's dementia~   "
33010|NCT03134950|"~     This project aims to test a stepped care behavioral intervention approach for youth with~     functional abdominal pain (FAP) that is feasible to administer in medical settings. Screening~     and a brief intervention (i.e. psychoeducation and relaxation training) are provided to youth~     with FAP with more than minimal functional disability (FDI score >7) during their medical~     visit as part of enhanced usual care (EUC). Patients are re-assessed after two weeks. Those~     that fail to respond to EUC (as evidenced by FDI score >7) are eligible to undergo a baseline~     assessment and then are randomized to receive either 1) a more intensive and tailored CBT~     approach, Aim to Decrease Anxiety and Pain Treatment (ADAPT), provided by a trained~     psychologist, or 2) medical treatment as usual (TAU). It is hypothesized that youth who~     participate in ADAPT will have lower average pain rating scores, less pain-related functional~     disability, and less anxiety symptoms (if elevated) at post-assessment as compared to youth~     receiving medical TAU.~   "
33011|NCT03134937|"~     High Flow Heated and Humidified Nasal Oxygen therapy (HFHHNO) has been increasingly used in~     emergency medicine to assist patients with short term respiratory failure and to provide~     adequate oxygen to the body prior to intubation.~      Gastric distension which is the bloating of the stomach due to air being pumped into it is a~     concern for anesthesiologists as it increases the risk of nausea and vomiting during surgery~     (aspiration).~      The objective of this study is use an ultrasound machine to measure the volume of fluid in~     the stomach before and after HFNO is used in a standard clinical manner.~   "
33012|NCT03134924|"~     Intravaginal practices (IVP) (cleansing or introducing products inside the vagina for~     hygiene, health or to please sexual partners) are common among women with HIV. IVP increase~     the risk of developing bacterial Vaginosis (BV), the most common genital infection associated~     with transmission of sexually transmitted infections and HIV. This study tested a pilot~     intervention to reduce IVP and BV in HIV infected women in Zambia. A total of 128 HIV~     infected women engaging in IVP were randomized to two conditions: enhanced standard of care~     (n = 70) and experimental (n = 58). All participants received a brief educational counseling~     session on discontinuation of IVP, and those with BV, were provided with medical treatment~     for BV. Women in the experimental condition received an additional group-based, culturally~     tailored intervention. Participants completed questionnaires assessing sexual risk factors~     and IVP and were assessed for BV using Nugent criteria at baseline, 6 months and 12 months.~   "
33013|NCT03134911|"~     The present study has been designed to describe the health-related quality of life in~     patients with non valvular atrial fibrillation who have been prescribed a specific~     anticoagulant treatment for their non valvular atrial fibrilation at least 6 months prior to~     study initiation. It will be conducted in Departments of Internal Medicine from approximately~     50 centers in Spain. It consists of an only visit that will coincide with one of those~     performed by the patients as part of routine follow-up of their disease. 500 patients seen in~     internal medicine are planned to be included in the study~   "
33014|NCT03134898|"~     The current data on the incidence of pulmonary hypertension (PH) are very variable, depending~     on the different studies designs. There are no data on the prognostic of PH in patients with~     asymptomatic pulmonary thromboembolisms (PT), neither paucisymptomatic PH, in which without a~     prospective follow-up would be underdiagnosed. We thought that the prognosis of both clinical~     forms (PT with or without symptoms) would be similar.~      The objective of this study is know the real incidence of pulmonary hypertension (PH) post~     symptomatic and asymptomatic pulmonary thromboembolic (PT).~   "
33015|NCT03134885|"~     VigilanS is an innovative healthcare program. Participants of this program are all patients~     leaving in the Nord-Pas de Calais region who survived a suicide attempt.~      General goals of the post hospitalization monitoring system for suicidal attempters are:~        -  Standardize general healthcare's practices by offering alert networks and innovative~          response procedures in case of suicidal crisis.~        -  Coordinate the various health partners' actions around the patient (GP, psychiatrist,~          psychologist).~        -  Contribute to reducing mortality and morbidity by suicide (subsequent suicide) in~          determined territories.~      The evaluation of VigilanS will be quantitative and qualitative.~   "
33016|NCT03134872|"~     SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody. This is a randomized,Phase III,~     multicenter ,open-label study designed to evaluate the safety and efficacy of SHR-1210 with~     carboplatin and pemetrexed versus carboplatin-pemetrexed in subjects who are chemotherapy~     naive and have Stage IIIB/IV non-squamous NSCLC.~      The primary hypothesis is that SHR-1210 combined with carboplatin and pemetrexed prolongs~     Progression Free Survival (PFS) in per RECIST 1.1 by blinded independent central review (ITT~     population and population was indicated by high PD-L1 expression) compared to carboplatin and~     pemetrexed treatment .~   "
33162|NCT03132974|"~     The Purpose of this trial is to investigate the efficacy and safety of herbal medicine with~     manipulation therapy on Korean Patients with Chronic Low Back Pain~   "
33017|NCT03134859|"~     The proposed study is a longitudinal, randomized control trial designed to determine the~     dosage of daily 'tummy time' needed in early infancy to influence ideal motor development and~     healthy body composition. Infants will be randomly assigned to one of three 'tummy time'~     groups: a group prescribed 0 to 30 minutes per day; a group prescribed 31 to 60 minutes per~     day; and, a group prescribed 61 or more minutes per day. Families will be encouraged to~     achieve the maximal minutes prescribed for their group and will keep a log of their daily~     tummy time. Participating infants will be assessed in their home for motor development and~     body composition at study entry and again every month for 12 months, at 15 months of age and~     at 18 months of age.~   "
33018|NCT03134846|"~     Surgery remains a main pillar in the treatment of head and neck squamous cell carcinoma~     (HNSCC). The margin status is the main prognostic factor of local tumor control in surgically~     treated HNSCC and will determine the postoperative treatment strategy. A margin of ≤1 mm of~     normal tissue is considered a positive margin and requires either a re-operation or~     postoperative chemoradiation with a combination of cisplatin and 5-FU, which substantially~     increases morbidity. Margins wider than 1 mm but less than 5 mm require re-operation, or, if~     that is not possible, post-operative radiotherapy without the concomitant use of~     chemotherapy. Currently, no technology is available in the operating room, which reliably~     supports tumor excision in terms of margin status. In fact, surgeons can only combine pre-~     operative imaging data with tactile and visual information during surgery for assessing tumor~     margins with limited accuracy. With the introduction of molecular imaging techniques using~     near infrared (NIR) fluorescent optical contrast agents coupled to targeted compounds, new~     avenues have opened up for intra-operative assessment of tumor margins. Tracers are based on~     antibodies directed against Vascular Endothelial Growth Factor-A, i.e.~     bevacizumab-IRDye800CW, in patients with breast cancer or against Epidermal Growth Factor~     Receptor, i.e. cetuximab-IRDye800CW, in patients with HNSCC. First trials have shown that~     systemic administration of these compounds is safe and tumor specific. These findings~     prompted us to design this innovative application in a clinical trial for the intraoperative~     assessment of tumor margins during surgical treatment of HNSCC using cetuximab-IRDye800CW.~   "
33019|NCT03134833|"~     The focus of this study (Engaging Seronegative Youth to Optimize HIV Prevention Continuum) -~     will be to stop HIV-related risk acts and to encourage youth at high risk for HIV to adopt~     antiretroviral medications as treatment and prevention (either pre exposure prophylaxis~     (PrEP) or post exposure prophylaxis) among gay, bisexual and transgender and/or homeless~     youth with contact with the criminal justice system in the HIV epicenters of Los Angeles and~     New Orleans. A cohort of 1500 youth at the highest risk of seroconverting over 24 months will~     be identified. The goal will be to optimize the HIV Prevention Continuum over 24 months. The~     proposed randomized controlled trial (RCT) aims to compare youth outcomes when randomized to~     one of four automated and person-mediated social media delivered intervention conditions: 1)~     Automated Messaging and Monitoring Intervention (AMMI) only (n=900) consisting of daily~     motivational, instructional, and referral text-messaging (SMS), and brief, weekly SMS~     monitoring surveys of outcomes; 2) Peer Support through social media plus AMMI (n=200) via~     private online discussion boards; 3) Coaching plus AMMI (n=200) to provide service linkages,~     eligibility support, appointment coordination and follow-up, communication with healthcare~     providers, and brief motivational and strengths-based counseling for linkage and retention to~     prevention, mental health, and substance abuse services; and, 4) Coaching plus Peer Support~     and AMMI (n=200).~   "
33020|NCT03134820|"~     Cancer is the most important acquired risk factor of thromboembolisms. More than 20% of all~     episodes of venous thromboembolism (VT) or pulmonary thromboembolisms (PT) are cancer~     related. Cancer patients with VT or PT are treated with low molecular weight heparins (LMWH)~     during at least 3 months, but nowadays the duration of treatment is not accurately~     determined.~      The D-Dimer determination has been used like recurrence predictors after LMWH treatment~     suspension, but in cancer patients the useful is limited. Phospholipid-dependent~     microparticles could been used like recurrence predictors in cancer patients and tailored the~     duration of LMWH treatment for each patient.~   "
33021|NCT03134807|"~     -  The primary aim is to document the incidence and short-term outcome of the elderly ICU~          patient (≥ 80 years) using a multicentre, multi national approach~        -  The secondary aim is to investigate the properties of a simple frailty index in this~          cohort, and in particular if this is an instrument that can be used in resource and~          outcome prediction in this group~        -  To create hypothesis for further studies, in particular on various outcome prediction~   "
33022|NCT03134794|"~     The main objectives of this study are:~      i) To design an educational tool to train physicians in overcome cognitive factors associated~     with therapeutic inertia.~      ii) To determine the feasibility and efficacy of an educational tool to overcome therapeutic~     inertia among neurologists caring for MS patients~      iii) identify the best strategy to disseminate an educational program to train physicians~     taking into account regional and practice variations.~      iv) To explore whether multiple sclerosis (MS) patients' risk category influence the~     incidence of therapeutic inertia in neurologists that may require a segmentation strategy in~     medical education.~      A multicenter, randomized, study including an educational intervention (applying the traffic~     light system) to overcome therapeutic inertia in MS care.~   "
33023|NCT03134781|"~     In this study the investigators utilized a novel hybrid HIIT (high intensity interval~     training) exercise training approach, the Fun and Functional Interval Training (FFIT) workout~     that combines interval training, resistance exercise training and functional training in~     order to test the hypothesis that FFIT will be able to: i) reduce body mass, ii) improve body~     composition and iii) alter energy balance, of previously inactive, overweight/obese women.~   "
33024|NCT03134768|"~     The purpose of the study is to understand the immediate effect of birth on immunological~     parameters in vaginally born cord blood.~   "
33025|NCT03134755|"~     This study aims to first determine whether high child stress leads to reduced response to~     common treatmenIs for asthma (inhaled corticosteroids and short-acting bronchodilators), and~     then to identify DNA methylation differences leading to stress-induced treatment resistance~     among children with asthma.~   "
33321|NCT03130881|"~     This phase I, first-in-human dose-escalation study was conducted to determine the maximum~     tolerated dose (MTD), recommended phase II dose (RP2D), dose-limiting toxicities (DLTs),~     pharmacokinetics (PK) profile, and preliminary antitumor activity of PLB1003.~   "
33026|NCT03134742|"~     Post-radiotherapy fragility fractures (caused by weakened bones) are an occasional~     complication of orthopedic oncology of soft tissue sarcoma patients. Treatment for impending~     fracture due to radiotherapy does exist in the form of operative stabilization, to prevent~     the bone from breaking. Without the ability to predict those patients at a higher risk for~     fracture, indications for treatment are difficult to determine. This study is to determine if~     there is a correlation between patients undergoing radiotherapy for soft tissue sarcoma and~     loss of bone density. The study wll evaluate bone loss for short and long term fracture~     prediction using dual-energy xray, absorptiometry (DEXA [DXA]) and computerized tomography~     scans (CT Scans)~   "
33027|NCT03134729|"~     A randomized prospective trial to assess whether the use of loco regional anesthesia as~     adjuvant analgesic therapy is more effective of intravenous analgesia only.~   "
33028|NCT03134716|"~     Our aim is to evaluate whether translocator binding protein (TSPO)-imaging correlates to~     Expanded Disability Status Scale (EDSS) and other disease progression-related clinical and~     paraclinical parameters in a homogenous cohort of 40-50-year old MS-patients, who are at risk~     of progression. The A2A-AR expression in this cohort will also be studied using the adenosine~     A2A-receptor (A2A-AR)-binding radioligand 11C-TMSX. The study cohort will also form the basis~     for a later follow-up study, which will be performed to evaluate the prognostic value of~     baseline TSPO-imaging in terms of disease progression. TSPO-imaging could thus be used as an~     imaging biomarker to help identifying patients to therapeutically prevent progression of MS.~   "
33029|NCT03134703|"~     This project provides a novel approach and an alternative care plan for infants with Neonatal~     Abstinence Syndrome (NAS). It is funded by the State of Florida and allows to: 1) educate and~     empower a specified population of mothers who are undergoing institutionalized rehabilitation~     and whose infant needs treatment for NAS; 2) safely transition the infants home for final~     wean of their pharmacologic treatment; 3) provide regular developmental follow up for these~     infants through our NICU follow up clinic, hence identifying and quickly responding to~     neuro-developmental delays.~   "
33030|NCT03134690|"~     The main outcome measures are the number of dominant follicles (≥13 mm) on the day of hCG~     trigger and the number of mature (MII) oocytes collected after conventional versus~     delayed-start ovarian stimulation protocol. Secondary outcome measures are including total~     number of oocytes retrieved, oocyte maturity rate (number of MII oocytes/total number of~     oocytes), oocyte yield (total number of oocytes retrieved/ antral follicle count [AFC]),~     mature oocyte yield (number of mature oocytes retrieved/AFC), total dosage of gonadotropin~     (recombinant FSH and/or highly purified hMG) needed, number of days needed for ovarian~     stimulation, quality of obtained embryos, fertilization rate (the proportion of total number~     of two-pronuclear [2PN] stage zygotes /per total injected MII oocytes), implantation rate~     (total number of observed gestational sac/ number of transferred embryos) and clinical~     pregnancy rate (presence of fetal heart beat by transvaginal ultrasound per embryo transfer).~   "
33031|NCT03134677|"~     This study evaluates the effects of different anesthetic techniques on QT, QTc, and Pwd in~     cesarean section. Half of participants received general anesthesia, while the other half~     received spinal anesthesia Electrocardiography (ECG) recordings were performed at~     preoperative, 5, 15, 30 min after initiation anesthesia and 30 min post-operatively.~     Hemodynamic state were also recorded at the same time intervals. QT, corrected QT (QTc), QT~     dispersion (QTd), QTc dispersion (QTcd), P-wave dispersion (Pwd), corrected JT interval, T~     wave (Tp-e), transmular dispersion of repolarization durations were measured from ECG records~     at predetermined time intervals of spinal or general anesthesia.~   "
33032|NCT03134664|"~     To test that the SuperPATH approach is more safe and reliable for hip functional recovery~     compared with the postolateral approach in the artificial hip replacement for femoral neck~     fractures in the elderly.~   "
33033|NCT03134651|"~     This study evaluated the effects of preoperative anxiety and dosage of anesthesia on IVF~     success. Half of participants according to the recorded Beck's Anxiety Inventory (BAI) score:~     a low-anxiety group, while the other half high-anxiety group.~   "
33034|NCT03134638|"~     This study will consist of two parts. Part 1 is a dose-escalation/safety evaluation to~     provisionally identify a dose and regimen of SY-1365 for further evaluation in Part 2.~     Approximately 35 patients with advanced solid tumors will be enrolled into Part 1 of the~     study.~      Following the identification of a recommended dose and regimen from Part 1, the study will~     enter Part 2 to further evaluate safety and the antitumor activity of SY-1365 in patients~     with select solid tumors, and to confirm target engagement and downstream pathway impact in~     patients with any solid tumor histology.~   "
33035|NCT03134625|"~     The development of acute rejection can only be considered in cases with increasing serum~     creatinine in patients with kidney transplantation. However, the serum creatinine itself is~     not specific but also accurate for detection of acute rejection. So The specific biomarker is~     required for acute rejection of kidney transplant. In this study, the investigators will~     enroll 200 consecutive kidney transplant patients in Seoul National University Hospital and~     follow up. Serial collection of urine and serum will be done. Acute rejection specific urine~     metabolite will be found by LC MS/MS.~   "
33036|NCT03134612|"~     This study aims to compare the effectivity between ondansetron 8 mg and lidocain 40 mg in~     preventing pain due to propofol injection~   "
33037|NCT03134599|"~     The purpose of this study is to evaluate the clinical performance and subject's preference~     out of three LRE (Limbal Ring Enhancing) lens types: enfilcon A (Johnson&Johnson),~     methafilcon A (Interozzo), and methafilcon A (CooperVision).~   "
33038|NCT03134586|"~     The purpose of this study is to determine whether Non-invasive endoscopic procedures (pillcam~     colon capsule endoscopy, PCCE) and non-ionizing radiological modalities (MR~     enterocolonography, MREC and ultrasound, US) - offer a sufficiently high diagnostic validity~     in patients with suspected CD compared to the traditional invasive approach using~     ileocolonoscopy with biopsies as first line diagnostic modality~   "
33039|NCT03134573|"~     The planned study will be a prospective, non-interventional, observational cohort study using~     the structure of a registry. Medication usage behavior will be observed for 6 months, while~     documentation behavior on the wellness tracker in the myBETAapp will be observed for 3~     months.~   "
33040|NCT03134560|"~     This study aims to compare intravenous cannulation success rate between using vein display~     instrument and without using vein display instrument in pediatric patients.~   "
33043|NCT03134521|"~     Daptomycin is validated as a treatment of bone and joint infections by the Infectious Disease~     Society of America. However, most of studies did not investigate daptomycin pharmacokinetics~     in this indication while it is known that efficacy and toxicity concentration studies show a~     close therapeutic margin.~      Evaluation of P-Glycoprotein (P-gp), a transmembrane transport protein, has demonstrated its~     influence on the concentration and intracellular activity of daptomycin. Recent work has~     linked the genetic polymorphism of P-gp to the pharmacokinetics of daptomycin, which may~     explain inter-individual variability but requires further explorations. Previous studies~     demonstrated existence of interindividual variabilities as sex, renal function and~     p-glycoprotein polymorphism couple with an intraindividual variabilities unexplained yet.~      A population approach will be used to determinate the pharmacokinetics factors, their intra~     and interindividual variabilities, the parameters associated to those variabilities (as the p~     glycoprotein).~      The investigator's goal is to evaluate different posology and to try to increase daptomycin~     efficacy and security in bone and joint infection.~   "
33044|NCT03134508|"~     : Inflammatory bowel diseases (IBD), such as Crohn's disease (CD) and ulcerative colitis (UC)~     need long term treatments which can conflict with a desire of pregnancy in women.~     Uncontrolled IBD increases the risk of poor pregnancy outcomes [1]. Antitumor Necrosis Factor~     α (antiTNFα) are commonly used, off-label, in pregnancy but with the risk of~     treatment-related complications. Existing recommendations on the use of antiTNFα during~     pregnancy are conflicting and only rely on expert opinions. This study was aimed to assess~     appropriateness and risk to benefit ratio of antiTNFα treatment during pregnancy in women~     with IBD, for both the mother and the baby until the end of the first year.~   "
33045|NCT03134495|"~     Pharmacological treatment of physiologic Gastro-esophageal Reflux disease (GERD) is excessive~     in France, as 65%-85% of children below 11 years are being treated, frequently with Proton~     Pump Inhibitors (PPIs) PPI have been associated, in adults, with an increase of infection~     rate but data in pediatry are scarce, especially in community medecine. Recently a study~     conducted in England brought up controversial results suggesting that the use of PPIs can be~     associated with a reduced risk of community acquired pneumonia.~      Our study was aimed to assess, on a population-based database, the association between PPI~     prescription and community infections in children of 11 years or under.~   "
33046|NCT03134482|"~     Polycystic ovarian syndrome (PCOS) is most common endocrinologic disease in women of~     reproductive age with incidence of 6.6 ~ 8%. About fifty percent of the patients with PCOS~     manifest subfertility and significant proportion of these woman need assisted reproductive~     technology (ART). These patients are very sensitive to gonadotropins during conventional in~     vitro fertilization (IVF) and the risk of ovarian hyperstimulation syndrome (OHSS) is high.~     In vitro maturation (IVM) is an emerging alternative option to conventional IVF for~     minimizing the risk of OHSS in patients with PCOS. Until now, several studies has been~     reported the favorable outcomes of oocyte maturation rate, fertilization rate, clinical~     pregnancy rate, and live birth rate during IVM procedure. However, these results were from~     retrospective or observational study and there was no suitable randomized controlled trial~     (RCT).~      Therefore, this prospective RCT is aimed to compare and analyze the clinical outcomes between~     IVM and minimal stimulation IVF in women with PCOS, assessing if IVM is recommendable~     clinical practice or not.~   "
33047|NCT03134469|"~     Efficacy of probiotics on excessive gas accumulation~   "
33048|NCT03134456|"~     This is a single center, open-label, single arm study in patients with metastatic non-small~     cell lung cancer (NSCLC) expressing PD-L1 after failure of platinum-based combination~     chemotherapy.~      Patients will be treated with Pembrolizumab according to the dosage and administration in~     Product Information of Keytruda in Korea (2mg/kg) until it is changed to 200mg flat dose.~      The patient should have their-own patient-derived xenograft (PDX) before enrollment of the~     study. The PDX will be used to set up their humanized CD34 PDX (Hu-CD34 PDX).~   "
33049|NCT03134443|"~     A multicenter, randomized, single-blind, placebo-controlled,phase 4 clinical trial to~     evaluate the efficacy and safety of andrographolide sulfonate in patients with acute~     tonsillitis~   "
33050|NCT03134430|"~     It has been reported local anesthetics could inhibit tumor cell proliferation, metastasis and~     invasion ability，but it is still lack of clinical evidence. Our study aims to explore the~     effects of regional nerve block on cancer recurrence and the mechanism.~   "
33051|NCT03134417|"~     The purpose of this study is to investigate the effects of a combined vitamin D and magnesium~     supplementation on parathyroid hormone and cardiometabolic health in persons living with~     obesity.~   "
33052|NCT03134404|"~     The skeletal system is one of the most common sites for metastatic spread of many~     malignancies. Metastatic bone disease (MBD) can be associated with a significant reduction in~     quality of life due to debilitating pain and pathologic fractures. Multiple providers are~     involved in treating patients with MBD which can result in fragmented and delayed delivery of~     care. This fragmentation also leads to poor outcomes and patient experience. This project~     will assess whether it is feasible to integrate a multidisciplinary Rapid Access Metastatic~     Bone Disease Program (RAMP) at the Investigator's institution to improve the delivery of care~     to patients presenting with pelvic and lower extremity MBD. The goals of RAMP are: 1) Improve~     outcome and quality of care provided to MBD patients. 2) Improve patients experience through~     the participant's treatment journey. 3) Avert extra health care costs caused by unplanned~     admissions through ER and decrease redundancies due to unnecessary multiple clinic visits and~     double-ordering of diagnostic tests. This project will be designed to optimize the use of~     existing clinic resources more efficiently. Cancer patients and their loved ones will be~     actively engaged in the design of this project to better achieve its goals.~   "
33053|NCT03134391|"~     This study aimed to evaluate the effect of vapocoolant spray and EMLA in reducing pain from~     spinal injection~   "
33071|NCT03134157|"~     Uterine leiomyomas with an estimated incidence of 50%-80% are the most common tumors of~     female reproductive system. Statins as a HMG-CoA reductase inhibitors inhibit the mevalonate~     pathway of cholesterol synthesis, thus have been known as a group of drugs used for treatment~     of hypercholesterolemia. Statins inhibit proliferation of several cell types including~     vascular smooth muscle, hepatocytes and other cell types. Leiomyomas are benign uterine~     tumors characterized by smooth muscle proliferation and excessive deposition of extracellular~     matrix. In the present study we aim to evaluate the effect of simvastatin on uterine~     leiomyoma development and growth.~   "
33054|NCT03134378|"~     Helicobacter pylori is a bacterium estimated to colonize in the gastrointestinal tract of the~     half population in the world. Colonization of this bacteria is suspected to be one of the~     main risk factor for the occurrence of various abnormalities of the upper gastrointestinal~     tract, such as peptic ulcer and gastrointestinal cancer. The Experts recommend giving triple~     therapy regimens as first-line eradication therapy for Helicobacter pylori infection. The~     recommended duration of triple therapy is 10-14 days. However, recent studies suggest triple~     therapy with longer duration will provide a higher percentage of eradication. This study~     wanted to show whether 14 days of triple therapy was better than 10 days in Helicobacter~     pylori eradication.~   "
33055|NCT03134365|"~     Aim: to determine the effect of palatability on the cognitive (satiation/fullness) and~     emotive (digestive well-being/mood) responses to meal ingestion. The postprandial responses~     to conventional (potato and cheese cream followed by vanilla cream) versus unconventional~     test meals (mixture of both creams) with identical composition (350 Kcal) and physical~     characteristics (colour, texture, consistency, temperature) but distinctively different~     palatability will be studied on a cross over-design. The responses to the meals will be~     tested on 2 different days.~      Participants (22 non-obese healthy men) will be instructed to eat a standard dinner the day~     before, to consume a standard breakfast at home after overnight fast, and to report to the~     laboratory, where the test meal will be administered 5 h after breakfast. Studies will be~     conducted in a quiet, isolated room with participants sitting on a chair. Perception will be~     measured at 5 min intervals 10 min before and 20 min after ingestion and at 10 min intervals~     up to 60 min after the probe meal.~   "
33056|NCT03134352|"~     This is a double-blind, randomized, placebo-controlled multi-center phase IIA study to~     evaluate the clinical efficacy and safety of Fugan ointment versus placebo applied to~     involved skin of subjects with mild to moderate subacute eczema.~   "
33057|NCT03134339|"~     The dose-effect curve to estimate a threshold delivery rate for reinforcement. The project~     addresses the FDA Center for Tobacco Products (CTP) interest #1: Nicotine dependence~     threshold among youth and adults and impact of nicotine reduction on tobacco product use~     behavior (e.g., topography, compensation, switching, multiple use, initiation, cessation and~     relapse). IV nicotine, in contrast to ECs, can deliver precise, reproducible dosing, which is~     necessary for accurately assessing dose-response and threshold effects. The estimated~     threshold for reinforcement will establish a benchmark for evaluating the addictive potential~     of ECs and other inhaled nicotine products.~   "
33058|NCT03134326|"~     In this study, the concentration of hemoglobin was measured using noninvasive pulse oximeter~     sensors and compared against the hemoglobin measurement from the subject's blood sample under~     controlled conditions. Data collected in the study was in the sub-range of 12-17 g/dL in the~     device's 8-17 g/dL specification range.~      The purpose of the study was to evaluate a change in the sensor component and to assess~     performance equivalence in the sub-range. The performance of non-invasive hemoglobin is not~     uniform across the accuracy range.~   "
33059|NCT03134313|"~     In this study, the concentration of hemoglobin will be measured using a noninvasive pulse~     oximeter sensor and compared with the hemoglobin value from a blood sample of the volunteer.~     The accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparison to~     hemoglobin measurements from a laboratory analyzer.~   "
33060|NCT03134300|"~     The investigators wish to study the role of persistent markers of inflammation in executive~     function in young children during critical periods of synaptogenesis (ages 2-3). While the~     role of markers of inflammation have been validated in the pathogenesis in multiple disorders~     in the adult population, their study in pediatrics is limited. The investigators therefore~     propose that demonstration of persistent cytokine inflammatory markers in this preliminary~     study will allow larger studies to proceed.~   "
33061|NCT03134287|"~     The study aimed to compare the efficacy between nasogastric tube placement using Two-Finger~     Method and Reverse Sellick's Maneuver~   "
33062|NCT03134274|"~     The study is a home-based, usability study assessing the use of the Dip Home-Based Dipstick~     Analyzer (HBDA) in the context of prenatal care.~   "
33063|NCT03134261|"~     An improved diagnosis of bone metastases in prostate cancer patients can have a significant~     impact on treatment strategy and probably survival as well.~      The primary purpose of the project is to determine the diagnostic accuracy of bone SPECT-CT,~     choline-PET-CT, PSMA-PET-CT, NaF-PET-CT and Whole-body MRI in the diagnosis of bone~     metastases in prostate cancer patients.~   "
33064|NCT03134248|"~     Bilateral dispensing study of MyDay Toric, 1-day Acuvue Moist for Astigmatism, and Dailies~     Aquacomfort Plus Toric lenses~   "
33065|NCT03134235|"~     This study evaluates the effects of a prescribed 4-week raw, plant-based dietary intervention~     in the treatment of excess body weight, hypercholesterolemia, and hypertension in the~     clinical setting.~   "
33066|NCT03134222|"~     The primary objective of this study is to evaluate the efficacy of filgotinib and GS-9876 in~     females with moderately-to-severely active cutaneous lupus erythematosus (CLE).~   "
33067|NCT03134209|"~     A single-center, phase IV, randomized, prospective study investigating the efficacy of~     various wound closure devices in reducing postoperative wound complications.~   "
33068|NCT03134196|"~     This is a multi-center, randomized, double-masked, placebo-controlled clinical trial of~     suppressive valacyclovir for one year in immunocompetent study participants with an episode~     of dendriform epithelial keratitis, stromal keratitis, endothelial keratitis, and/or iritis~     due to Herpes Zoster Ophthalmicus (HZO) in the year prior to enrollment.~   "
33069|NCT03134183|"~     This study aims to compare mifepristone and buccal misoprostol to mifepristone and vaginal~     misoprostol for cervical preparation for second trimester dilation and evacuation (D&E).~   "
33070|NCT03134170|"~     This study is a randomized controlled cross-over trial, in the form of a proof of concept~     study that is designed to evaluate the health outcomes resulting from incorporating a~     licensed clinical pharmacist in a health care team to provide case management for diabetic~     patients at the Henry J Austin Health Clinic. The study uses a control group design and will~     feature both an experimental group and a control group. The control group, of 80 patients,~     will receive the standard treatment at the clinic. The experimental group, of 80 patients,~     will receive the standard treatment as well as Medication Therapy Management and counseling~     from a pharmacist. After one year the patients in the control group can cross-over to the~     intervention group and receive care from the pharmacist.~   "
33072|NCT03134144|"~     Standing work is associated with increased risks of venous and musculoskeletal disorders;~     particularly low back pain is commonly reported in prolonged standing work. In manufacturing~     work, workstations often do not allow standing aids due to insufficient functional and~     spatial conditions. In 2014, the car manufacturer Audi introduced the lower leg exoskeleton~     developed by Noonee to their employees working in the factories. This exoskeleton, the~     'Chairless Chair' has the advantage that standing work can be performed while technically~     sitting on this device. The exoskeleton offers the potential for reduced awkward body~     postures, but it is unclear which physiological and biomechanical loads are influenced and~     how. This proposal provides a study design evaluating the 'Chairless Chair' in a laboratory~     setting, by testing its effectiveness in terms of physiological and biomechanical parameters.~     It is suggested to compare different assembly tasks while wearing the exoskeleton, compared~     with not wearing the exoskeleton. The 'Chairless Chair' is developed in one size only, which~     is why we propose to include participants of different body height, which will enable us to~     investigate whether body height influences the effectiveness of wearing the device.~   "
33073|NCT03134131|"~     The objective of this expanded access program is to provide ONC201 on a single patient~     compassionate use basis to eligible adult subjects with recurrent glioma that exhibits a~     missense histone H3 mutation .~   "
33074|NCT03134118|"~     The aim of the phase II Nivothym study is to collect data on activity and toxicity of~     nivolumab therapy in patients with thymic carcinoma or type B3 thymoma that previously~     received a first platinum-based chemotherapy.~   "
33075|NCT03134105|"~     The AWARE-Angina study is a cluster randomized trial aimed at evaluating whether routine~     provider feedback of patients' angina burden and activity level can improve angina control.~     Patients will wear an activity monitor for 6 months, and their providers will be randomized~     to receive either monthly feedback or feedback at the end of the study period.~   "
33076|NCT03134092|"~     To compare the effectiveness of 3 strategies to inform patients of their risks associated~     with misuse of opioid prescriptions after treatment in the ED from renal colic or~     musculoskeletal back pain. Randomization will be to 3 arms for the Randomized Practical~     Control Trial across 3 sites (A) standardized general risk information sheet only (B)~     standardized general risk information sheet plus a visual probabilistic risk tool (C)~     standardized sheet plus narrative enhanced probabilistic risk tool.~   "
33077|NCT03134079|"~     This study aims to reduce the amount of sugar in a particular food item and add spices to see~     if the food liking of that item rates as high or higher in a post meal survey. Through the~     weekly feeding and testing of the menu items we will determine an opinion of the~     participants. Results of these surveys will determine whether participants enjoy the reduced~     sugar options as much as their full sugar counterparts.~   "
33078|NCT03134066|"~     There is an urgent need for novel and effective interventions for treatment-resistant~     depression (TRD). In previous studies, ketamine has been shown to rapidly reduce depressive~     symptoms; however, the exact mechanisms of action of ketamine remain unknown. There are some~     preliminary findings to suggest that ketamine may exert its antidepressant effects through~     promotion of neurogenesis in the dentate gyrus. The aim of this study is to help delineate~     the neurocognitive effects of ketamine exposure using a behavioral task (specifically, a~     pattern separation task) and a battery of other well-established cognitive measures.~      This is an assessment-only study, as we will be recruiting subjects to complete an assessment~     battery at two time points, before and after receiving ongoing ketamine administrations for~     at least four weeks.~   "
33079|NCT03134053|"~     Assess the effect of extracorporeal shock waves on hypertrophy scar~   "
33080|NCT03134040|"~     This study is for physically inactive adults with an active membership at a Greater~     Providence Young Men's Christian Association (YMCA).~      Participants will receive weekly feedback on their attendance at the YMCA, and will be~     enrolled in the study for 1 year.~      Participants will be assigned to one of three conditions, to either receive weekly: (i)~     monetary incentives, (ii) donations to a charity of their choice, or (iii) feedback only.~      In order to continue to receive incentives, participants must maintain an active membership~     at the YMCA.~   "
33081|NCT03134027|"~     The objective of this study is to obtain human blood CD34+ hematopoietic stem/progenitor~     cells (HSPCs) to reconstitute a match human immune system in our PDX model. The hypothesis is~     that by using matched leukocytes and PDX from the same patient, rejection of the PDX by the~     host immune system will not be observed and therefore a preclinical model to study~     immunotherapy can be developed to study, understand and improve upon our current therapies.~     HSPCs will be collected from bone marrow aspirate obtained from a bone marrow biopsy.~   "
33082|NCT03134014|"~     75 overweight, habitual 'breakfast-skipping' adolescents will complete the following~     long-term, randomized controlled trial. Participants will be randomly assigned to the~     following breakfast treatments: 350 kcal high protein breakfasts containing 30 g protein~     (primarily from lean beef), 35 g carbohydrates, and 10 g fat; 350 kcal normal protein~     breakfasts containing 10 g protein, 55 g carbohydrates, and 10 g fat; or will continue to~     skip breakfast. The following outcomes will be assessed during baseline and 4-month~     (post-intervention): body weight & body composition; waist circumference; daily food intake;~     24-h free-living glycemic control; and pre and post-prandial satiety. In addition, body~     weight and free-living breakfast intake (quantity, quality, and type) will also be assessed~     at 2-month follow-up~   "
33083|NCT03134001|"~     Randomized, open label, controlled pilot clinical study comprised hospitalized post operative~     patients receiving oral analgesics. The study aims to evaluate the safety, efficacy and~     usability of a novel pill dispensing system - PCoA™ Acute and compare it to the conventional~     procedure of nurse providing analgesics.~   "
33084|NCT03133988|"~     The purpose of the Expanded Access program is to provide margetuximab to patients with breast~     cancer and other HER2+ carcinomas who are not otherwise eligible for a MacroGenics sponsored~     study and the potential benefit justifies the potential risk of treatment use.~   "
33085|NCT03133975|"~     This study will be conducted to Assess possible reduction in lipid profile~     (LDL-Triglecerides-cholesterol) among pre-menopausal women in vit D group compared to~     standard treatment group after 3 months & 6 month of follow up as prophylaxis step for~     atherosclerosis.~   "
33322|NCT03130868|"~     The purpose of the study is characterizing changes in the microbiome of severely-injured~     adult patients as they progress through stages of injury, reconstruction, and recovery from~     burns.~   "
33086|NCT03133962|"~     Given the increase in the number of PAC implants or long-term catheters, and the ease of~     access to cardiac ultrasound in the operating theaters, the investigator thought to use~     ultrasound to PAC or long-term catheters.~      The investigator considers cardiac echocardiography through its costal pathway to locate the~     correct positioning of the distal end of the catheter in a manner equivalent to the scopic~     locating with all the side effects of the irradiation and with Equivalent efficiency~   "
33087|NCT03133949|"~     Inflammatory aortitis probably represents a heterogeneous group, and the clinical experience~     accumulated over the last ten years, shared by the experts of the subject, is that the~     initial clinical, biological or radiological characteristics should make it possible to~     differentiate them and dismember the Nosological field.~      This will be an essential first step before studying prognosis, risk factors, and therapeutic~     options.~      The search for diagnostic criteria on a large series, similar to the study of classification~     of vascularites of the ACR in 1990, should make it possible to homogenize the diagnoses for~     the different teams working on the subject, and to begin work Collaborations, which alone can~     improve patient care in the future.~   "
33088|NCT03133936|"~     The purpose of this study is to evaluate the immune response in recipients of the vaccine.~     After participants receive the vaccine, samples of blood will be obtained at several~     intervals afterwards. These blood samples will be used to measure the immune response to the~     vaccine. Everyone in this study will receive a single dose of flu vaccine, and have blood~     samples drawn to measure the immune response over the next 90 days. The investigators will~     also ask participants to report any flu like illnesses during the flu season, and if~     participants develop a fever or cough, to come in to be tested for flu. This will allow the~     investigators to compare the vaccine response between people who got the flu and those who~     did not.~   "
33089|NCT03133923|"~     Mumps is an acute infectious respiratory disease caused by the mumps virus (MuV), which~     occurs mainly in children and adolescents. Its main clinical symptoms were parotid gland~     suppurative swelling and pain with fever. The pathological changes and harm caused by mumps~     was not only confined to the parotid gland, on the contrary, the social harm caused by~     serious complications cannot be ignored. As mumps is a vaccine-preventable infectious~     disease, vaccination is a fundamental strategy for controlling mumps. So far, there are 13~     genotypes of MuV. Based on the analysis of molecular epidemiology, the main epidemic strain~     of MuV in China was the F genotype. The commonly used vaccine strains represented only a~     small number of known genotypes, e.g. Jeryl-Lynn (JL) and Rubini strains, which belong to~     type A, Urabe strain belongs to type B, and L-Zagreb strains belongs to type D. Virus seed of~     Live Attenuated Mumps Vaccine (Human diploid cell) developed by the institute was SP-A~     strain, which was the first separation and preparation of the attenuated mumps viruses in~     China. SP-A belongs to F genotype, which was the domestic epidemic genotype. In addition, the~     cell substrate prepared for vaccine was human diploid cell (KMB-17 strain), which is much~     safer to use. The preliminary test results showed that the vaccine possessed good~     immunogenicity and good antigenic cross-reactivity. The application of this vaccine will~     provide more effective means to prevent and control of mumps epidemic.~   "
33090|NCT03133910|"~     Mortality benefit has been proven with early antibiotic administration in sepsis.~     Antimicrobial therapy should be based on early achievement of effective drug concentrations~     by optimizing the pharmacokinetic/pharmacodynamics of individual drugs. Optimal dosing in the~     critically ill patient can be challenging with the rapidly changing physiology of sepsis~     during the first days of hospitalization with capillary leak, fluid overload, changes in~     cardiac output, and alterations renal clearance. Ceftazidime is the preferred beta-lactam for~     empiric treatment of sepsis at Lurie Children's Hospital because of its anti-pseudomonal and~     anti-enteric bacilli coverage, however, the majority of pharmacokinetic data currently~     published in pediatrics does not include Intensive Care Unit (ICU) patients. Adult~     pharmacokinetic/pharmacodynamics data suggest that critically ill adults with high level of~     illness severity may benefit from continuous or extended infusion beta lactam therapy to~     optimize the therapeutic concentration particularly for pathogens that are relatively~     resistant to beta-lactams. Understanding the changing pharmacokinetic/pharmacodynamics of~     ceftazidime with the progression of illness in the ICU may help determine if current dosing~     regimens are adequate to maintain appropriate drug concentrations to optimize antimicrobial~     treatment.~   "
33091|NCT03133897|"~     Current corticosteroid regimens for children hospitalized with asthma typically include a~     5-day course of prednisone or prednisolone. However, these medications taste poorly and are~     associated with vomiting and poor compliance. Outpatient evidence suggests that a 2-day~     course of dexamethasone is as effective as a longer course of prednisone and prednisolone,~     and better tolerated. Studies in hospitalized patients are lacking.~      The investigators' primary objective is to determine the feasibility of a non-inferiority~     trial, comparing 2 days of dexamethasone to 4 days of inpatient prednisone/prednisolone for~     inpatient asthma treatment. The investigators also wish to determine the feasibility of 1)~     enrolling patients upon admission to hospital, 2) asking patients and/or caregivers to~     complete a symptom weekly for 4 weeks, 3) reassessing patients post hospital discharge, 4)~     successfully completing phone follow up 4 weeks post hospital discharge, and 5) collecting~     health utilization data post hospital discharge.~      This study will inform a future multi-site trial comparing prednisone/prednisolone to~     dexamethasone in inpatient asthma treatment. It has the potential of improving the delivery~     of care in asthma, by improving compliance with a mainstay of treatment. It will also enhance~     collaboration within Ontario pediatric hospitals, facilitating knowledge translation and~     standardization of care across institutions.~   "
33092|NCT03133884|"~     Two hundred and eighteen patients with chronic tension-type headache(CTTH) will be randomly~     assigned to an experimental group (acupuncture) and a control group (superficial acupuncture)~     in a 1:1 ratio. Participants in both groups will receive 20 sessions of acupuncture over 8~     weeks, and the same acupoints will be selected in acupuncture treatments.The study cycle will~     last 36 weeks, including a 4-week baseline period, a 8-week treatment period and a 24-week~     follow-up period. And the primary outcome will be measured at the end of 16th week. While,~     the secondary outcomes will be measured at the baseline, the 4th,~     8th,12th,16th,20th,24th,28th and 32nd week after randomization.After each treatment,~     participants will finish the Massachusetts General Hospital (MGH) Acupuncture Sensation Scale~     (MASS) to evaluate deqi sensations.~   "
33094|NCT03133858|"~     Adequate pain therapy is important aspect of perioperative care. Sequelae of inadequate pain~     management are patient dissatisfaction, post-operative nausea and vomiting (PONV), inadequate~     nutrition, lack of mobilization, and an increased risk for the development of further~     complications, such as postoperative delirium (POD). The use of patient-controlled analgesia~     (PCA) systems, which allow patients to self-administer analgesics, has improved pain~     management. Conventional i.v. PCA and the non-invasive administration of sufentanil~     sublingual tablets (ZALVISO®) are available. The aim of this investigation is to study~     patient controlled analgesia systems and to examine the incidence of POD, POCD and~     postoperative pain.~   "
33095|NCT03133845|"~     The purpose of this study is to determine if light sedation with spinal anesthesia reduces~     the incidence of delirium compared to receiving general anesthesia during spinal surgery in~     older adults.~   "
33096|NCT03133832|"~     Schistosomiasis remains an important parasitic disease in the tropics, special in Africa~     including Zanzibar. The WHO-recommended strategy to eliminate schistosomiasis involves~     large-scale treatment of affected populations through periodic, targeted treatment of~     school-children with praziquantel. Donated praziquantel is the key to achieving elimination.~     The increase in the number of treatments is attributable to many factors, including improved~     availability of donated praziquantel, essentially from Merck; new countries starting to~     implement large-scale schistosomiasis control programmes; geographical scale-up of treatment~     within countries; and improved reporting to WHO. The global target set by WHO in the Roadmap~     on neglected tropical diseases is to attain at least 75% coverage of preventive chemotherapy~     in pre-school and school-age children by 2020. Experience from China demonstrates that~     preventive chemotherapy (that is, large scale treatment without individual diagnosis) with~     high coverage can significantly impact indices of infection and reduce transmission. The~     praziquantel made in China has been used from 1990s, and have effectively activity against S.~     haematobium, special the good economic benefits.~      The project will propose to conduct an open-label, randomized trial to evaluate the~     comparative efficacy of Chinese-made Praziquantel versus WHO Praziquantel in the treatment of~     200 people infected with S. haematobium in Pemba island Zanzibar. To do this the~     investigators will screen about 4000 people by examination of urine for schistosome eggs.~     Eligible participants will be randomized to receive a single dose of Chinese-made and WHO~     Praziquantel. Four weeks after treatment, the participants will be assessed for cure and egg~     reduction. The study may provide an alternative drug treatment for S. haematobium.~   "
33097|NCT03133819|"~     Peripheral neuropathy is just assessed by determination of Vibration sensation, pressure~     sensation, superficial pain or temperature. The most commonly used technique for diagnosis of~     peripheral neuropathy is nervous conduction (NC) and electromyography (EMG). But EMG/NC is~     bothersome and techniques using electric currents to measure NC and needles to study muscle~     innervations are uncomfortable.~      Quantitative NeuroSensory Testing (QST) is essential in the evaluation of small-caliber~     A-delta and C-fibers, the primary transmitters of thermal and pain sensation. QST can~     demonstrate neurosensory abnormalities when it is non-invasive test, selective to small~     fibers despite negative EMG/NCV finding.~      The investigators predict QST can be used for the early diagnosis and follow-up of~     small-fiber neuropathy in diabetes patients. The investigators also predict the early~     evaluation of diabetes neuropathy with QST can reduce the diabetes patient progress to~     advance stage of DM foot or limb amputation.~   "
33098|NCT03133806|"~     The purpose of the study is to demonstrate the safety and the rate of closure of the~     Ultrasept Left Atrial Appendage (LAA) Closure System for the percutaneous occlusion of the~     left atrial appendage in patients with non-valvular atrial fibrillation.~   "
33099|NCT03133793|"~     The purpose of this study is to compare the clinical benefits of CoQ10 and D-ribose taken by~     patients who have diastolic heart failure, or heart failure with preserved ejection fraction~     (HFpEF).~   "
33100|NCT03133780|"~     Patients during spinal anesthesia should be sedated.~   "
33101|NCT03133767|"~     Administration of intravascular (IV) fluid is the most common emergency department (ED)~     procedure. IV fluids are integral to increasing effective blood volume and ensuring organ~     perfusion in patients with volume depletion and dehydration. There are many options of IV~     fluids providers can use when treating ED patients. Surveys show physicians do not cite an~     evidence-based reason for selecting the crystalloid IV fluid used; the decision was likely to~     be influenced by type and location of practice. A gap exists in the current literature, as~     there is no evidence for the optimal IV fluid choice for the ED patient requiring IV fluid~     before discharge.~      Normal saline (NS) is commonly used as an IV fluid replacement in ED patients. However, NS~     has been associated with increased risk of acidosis and acute kidney injury. This study will~     use a novel approach of a patient-centered outcome in a non-critically ill population to~     ascertain the optimal IV fluid for patient quality of recovery. The results of this study~     will inform provider's IV fluid decisions between NS and LR. More importantly, the results of~     this study will have the power to improve patient's quality of recovery following IV fluid~     administration and subsequent ED discharge.~      ED patients will be recruited, and participants will be randomized to receive one of two IV~     solutions (Lactated ringer's or normal saline). Participants will answer a survey before and~     after the intervention to assess their quality of recovery. The post-survey will be~     administered by phone after ED discharge. Participants will also be contacted by text message~     one week following their ED visit to gather information on their healthcare utilization.~   "
33102|NCT03133754|"~     This study aims to compared the effects in driving pressure of an open-lung strategy with a~     positive end-expiratory pressure (PEEP) titrated to best driving pressure (DP) after a RM~     versus the recommended protective PEEP of 5 cmH2O without a recruitment manuever in non-obese~     patients undergoing cardiac surgery.~   "
33103|NCT03133741|"~     Delinieation of GIP's effects during an oral glucose tolerance test (OGTT) in humans using~     GIP receptor antagonisation.~   "
33104|NCT03133728|"~     The purpose of the study is to test the effect of the Alere™ q HIV-1/2 Detect (diagnostic~     assay) on uptake of HIV testing among HIV-exposed infants and young children, and health~     outcomes for HIV-infected infants and young children in Zambia. It will also assess the~     feasibility of field implementation of this novel diagnostic tool and its acceptability among~     HIV-infected mothers and frontline health workers.~   "
33105|NCT03133715|"~     Randomized trial to compare outcomes of robot-assisted and laparoscopic ventral hernia repair~     surgery.~   "
33109|NCT03133663|"~     The purpose of this study is to determine whether using electrocardiograms (ECGs) during~     resuscitation of preterm infants (less than 31 weeks gestation) will decrease the amount of~     time it takes from birth for heart rate (HR) to be above 100 beats per minute and oxygen~     saturations to be in the goal range, in other words to stabilize the infant. A few studies~     have been conducted which showed that ECGs are faster at detecting HR than pulse oximetry~     (PO). Sample sizes, however, have been small and only few extremely low birthweight infants~     have been included. It is unclear if use of ECG in these tiny preterm infants in addition to~     traditional techniques to determine HR will be beneficial and impact resuscitation and~     outcomes. The investigators propose a study where infants will be randomized to either using~     ECG in addition to PO ± auscultation versus PO ± auscultation only to assess HR during~     neonatal resuscitation. The investigators hypothesize that the group of infants randomized to~     ECG will be able to stabilize faster, i.e. achieve HR > 100 beats per minute and oxygen~     saturation in goal range faster.~   "
33110|NCT03133650|"~     The purpose of this study is to establish the highest dose of laser light for WST-11 VTP to~     treat obstruction from esophageal cancer that can be safely given.~   "
33111|NCT03133637|"~     Ceftriaxone is an antibiotic often used for the management of sepsis. Neonates commonly have~     jaundice during the first postnatal week. The effect of ceftriaxone on jaundice has not been~     investigated in well designed studies~   "
33112|NCT03133624|"~     This is a registry study on a multidimensional prediction model for rupture risk of~     unruptured intracranial aneurysms in China.~   "
33113|NCT03133611|"~     Speech is an important indicator of motor function and movement coordination and can be~     extremely sensitive to involvement in the course of neurologic diseases. The aim of this~     project is to discover for the first time using simple speech recording and high end pattern~     analysis preclinical stages of disabling central nervous system disorders including~     Parkinson's disease and other alpha-synucleinopathies in at high risk patients with REM~     sleep behavior disorder and thus provide one essential prerequisite for trials on REM sleep~     behavior disorder with preventive therapy.~   "
33114|NCT03133598|"~     Un-ruptured intracranial aneurysm is a complex disease that seriously affects human life and~     health. At present, the treatment of intracranial aneurysm is divided into interventional~     treatment and craniotomy clipping, the two treatment methods are different in the~     intervention effect of aneurysm, for example, the complications of interventional therapy are~     lower than craniotomy clipping, but the long-term patency rate is lower than craniotomy~     clipping, and there is no standard of treatment in different parts of aneurysm in our~     country, the choice of intervention measures of un-ruptured aneurysm is different in~     different clinical centers; on the other hand, there are serious problems in the treatment of~     aneurysms, because without the relevant guidelines of diagnosis and treatment of intracranial~     aneurysms, different clinical centers will cause excessive treatment of un-ruptured~     aneurysms, not only bring unreasonable utilization of medical resources, but also cause the~     subject's life and property to be threatened.~      The patients with un-ruptured intracranial aneurysm(n=1500) were included in prospective~     cohort study, after clipping and intervention operation, setting fixed time for postoperative~     follow-up, the clinical data and image data were recorded, the safety, efficacy and economic~     benefits of interventional treatment and craniotomy clipping were compared, providing~     strategies for the standardized treatment of un-ruptured intracranial aneurysms.~   "
33115|NCT03133585|"~     To evaluate the satisfaction of patients of the Flexima®/Softima® 3S with 6 months follow-up.~      The primary variable is to evaluate the degree of satisfaction of patients in terms of~     leakage prevention, comfort and patient's feeling of security to the Flexima®/Softima® 3S.~   "
33116|NCT03133572|"~     Mortality rates from birth asphyxia in low-income countries remain very high. Face mask~     ventilation (FMV) is the most common method of resuscitating neonates in such settings. It is~     mostly performed by midwives but may not always be satisfactory. The i-gel® is a cuffless~     supraglottic airway which is easy to insert and provides an efficient seal that prevents air~     leakage with the potential to enhance the performance of neonatal resuscitation. Midwives can~     be trained in a short time to use this method. A pilot study in Uganda has demonstrated that~     midwives can safely perform resuscitation of newborn with the i-gel.~      OBJECTIVE To investigate whether the use of a cuffless supraglottic airway compared to~     face-mask ventilation during neonatal resuscitation can reduce early neonatal death (before 7~     days of life) or morbidity in neonatal encephalopathy (NE) in asphyxiated neonates.~      STUDY DESIGN, SETTING AND POPULATION A multi-centre randomized clinical trial will be~     conducted at Central Hospital, Beira, Mozambique and at Mulago Hospital, Kampala, Uganda,~     among asphyxiated neonates in the delivery units. Prior to the intervention, all staff in the~     labour ward performing resuscitation will receive training according to the HBB curriculum~     with a special module for training on supraglottic airway insertion. Resuscitation will be~     performed according to international guidelines.~      UTILITY OF THE STUDY It is crucial to explore alternative, cost-effective modalities that not~     only would reduce mortality, but also the burden of neurological damage in survivors.~   "
33117|NCT03133559|"~     Individuals infected with HIV have a high risk of developing metabolic comorbidities not~     traditionally associated with the immune dysregulation and deficiency associated with HIV~     infection and AIDS. Many of these comorbidities in HIV uninfected individuals have been~     linked to a disordered circadian clock function. The study investigators will further~     evaluate the circadian clock in HIV infection as a mechanism underlying the metabolic~     dysregulation in this population.~   "
33118|NCT03133546|"~     BOOSTER is a randomised, controlled, phase II trial comparing osimertinib and bevacizumab~     versus osimertinib alone as second-line treatment in patients with stage IIIb-IVb non-small~     cell lung carcinoma (NSCLC) harbouring activating EGFR (exon 19 deletion or L858R) and T790M~     resistance mutation.~   "
33119|NCT03133533|"~     Randomized trial to compare outcomes of laparoscopic and robot assisted inguinal hernia~     repair.~   "
33120|NCT03133520|"~     Effectiveness of high flow oxygen therapy in patients with hematologic malignancy acute~     hypoxemic respiratory failure~   "
33193|NCT03132571|"~     The purpose of this study is to determine the efficacy of combining open-label extended~     release bupropion (flexible dosing up to 450mg target) and naltrexone (37.5mg) versus~     Bupropion and placebo along with a daily 500 calorie reduction diet recommendation for weight~     and health risk reduction in 40 overweight/obese individuals with schizophrenia and diabetes.~   "
33121|NCT03133507|"~     This study tested the effects of emotion regulation strategies (reappraisal, reassurance, and~     empathy) on pain responses in children with cancer. Children with cancer were randomly~     assigned to one emotion regulation strategy during an experimental pain task (the cold~     pressor task [CPT]). During the CPT, children rated their pain and provided saliva samples~     immediately before, after, and then 15 minutes after the CPT. This study examined the~     influence of emotion regulation on self-reported pain and physiological activity assessed~     through saliva samples.~   "
33122|NCT03133494|"~     The investigator found out that as such the base line carbon dioxide (CO2) level is higher in~     smokers as compared to non-smokers even before creation of pneumoperitoneum, which is due to~     the compromised lung function following chronic smoking. This condition gets aggravated after~     creation of pneumoperitoneum which is very much evident from the serial arterial blood gas~     analysis. The level of CO2 remains elevated even after deflation of the pneumoperitoneum.~     Hence one has to be very much vigilant not only during intra-operative period but also in~     post-operative care unit. Hence serial ABG monitoring should be included as a part of the~     protocol especially in laparoscopic surgeries.~   "
33123|NCT03133481|"~     Peripheral nerve blocks catheters of the femoral nerve have long been used for perioperative~     analgesia in total knee arthroplasty (TKA). These blocks provide effective analgesia and~     patient satisfaction for surgical pain relief. However, one of the main drawbacks to the~     femoral nerve block (FNB) is a denser motor block of the quadriceps muscle that can delay~     aggressive physical therapy and subsequent recovery from surgery. (1) Recently, there has~     been increasing interest in performing adductor canal blocks (ACB) with the aim of less motor~     blockade while providing commensurate analgesia compared to the FNB. (1,2) Current~     investigative reports have provided only preliminary data, and there is potential to change~     the standard of care for TKA as more data mounts in favor of ACBs. The goal of this study is~     to verify the analgesic equivalence of the two blocks, compare patient satisfaction, surgeon~     satisfaction, and physical therapy grading between the two blocks. Potentially, this would~     change the standard of care for TKA patients at this institution.~   "
33124|NCT03133468|"~     This study will be conducted to determine the safety and tolerability of single and multiple~     oral ascending doses of AJM347 in healthy male participants, and to assess the~     pharmacodynamic response following single and multiple oral ascending doses of AJM347 in the~     same population. This study will also aim to determine the single and multiple oral ascending~     dose pharmacokinetics of AJM347 and its metabolite in healthy male participants, and to~     determine the effect of food on the single and multiple oral dose pharmacokinetics of AJM347~     and its metabolite in the same population.~   "
33125|NCT03133455|"~     Dysfunctional chronic diffuse pain syndrome, concerning 2% of the French population,~     Fibromyalgia (FM) is classified either as a psychological disease or as a somatic disease.~     This dichotomous reasoning does not lead to a better understanding and does not allow the use~     or development of new psychological tools of care.~      The issue of the proximity between FM and depression highlighted by some authors and the~     presence of anxious comorbidities may arise at a different level, that of the transdiagnostic~     approach. Rumination is one of these transdiagnostic processes that are the subject of recent~     studies and one of the dimensions of which (abstract analytical rumination) is at work in~     depression and a number of psychopathologies. The investigator therefore wishes to explore~     the process of rumination and its abstract analytical dimension in FM and to explore its link~     with the depressive and anxious manifestations frequently associated with this disorder.~   "
33126|NCT03133442|"~     Vestibular stimulation might be beneficial for sleep. Previous research demonstrated that~     lateral rocking movements can facilitate the transition from wake to sleep during an~     afternoon nap. However, the relationship between rocking movements and sleep is poorly~     understood to date. Furthermore, studies looking at the effects of rocking on sleep have not~     yet been performed in an elderly population. Due to age related changes in sleep, people~     often experience a decrease in sleep efficiency and sleep quality later in life. Therefore,~     it is particularly this population that could benefit from a possible enhancement in sleep~     efficiency and sleep quality. In order to assess the effect of vestibular stimulation on~     sleep and sleep-dependant memory, measurements of two nights with stimulation will be~     compared to two baseline nights. The primary outcomes are changes in sleep onset, sleep~     architecture and power density spectra of the EEG due to vestibular stimulation. Secondary~     endpoints are sleep dependent changes in memory, the proximal-distal temperature gradient,~     cardiorespiratory variables and dream content.~   "
33127|NCT03133429|"~     The aim of the study is to confirm, whether the MER® stent can be used, without limitations,~     for the endovascular carotid stenosis treatment in daily clinical practice. Eligible patients~     will undergo the procedure of the common or internal carotid artery stenting using MER® with~     proximal or distal neuroprotection.~   "
33128|NCT03133416|"~     The investigators aim to investigate whether combination of PRP injection with physiotherapy~     program could produce superior effect than either treatment alone.~   "
33129|NCT03133403|"~     The purpose of this study is to assess the efficacy of autologous PBSCT versus FDA approved~     standard of care (i.e. interferon, glatiramer acetate, mitoxantrone, natalizumab, fingolimod,~     or tecfidera) for inflammatory MS failing alternate approved therapy.~      Disease progression, defined as a 1-point increase in the Expanded Disability Status scale~     (EDSS) on consecutive evaluations at least 6 months apart and not due to a non-MS disease~     process. Patients will be followed for 5 years after randomization.~   "
33130|NCT03133390|"~     This is a randomized phase II study assessing the activity of bevacizumab combined with~     atezolizumab compared to atezolizumab alone in metastatic urothelial carcinoma subjects who~     are ineligible for cisplatin-based therapy. Eligible subjects will be randomized to receive~     treatment with either (Arm A) atezolizumab 1200 mg (flat dose) IV plus bevacizumab 15 mg/kg~     IV every 21 days versus (Arm B) atezolizumab 1200 mg (flat dose) IV monotherapy every 21~     days. Cross-sectional imaging will be performed every 9 weeks on therapy for the first 12~     months and then every 12 weeks thereafter to assess for response.~   "
33194|NCT03132558|"~     Computed tomographic angiography (CTA) is recommended for identifying eligible patient with~     acute ischemic stroke (AIS) to receieve endovascular treatment. We are going to conduct this~     prospective corhot study to observe if sequential use contrast in CTA examination and in~     endovascular treatment will cause acute kidney injury.~   "
33131|NCT03133377|"~     The aim of this study is to evaluate the effect of early activity and mobilisation during~     prolonged IMV on the composite outcome days alive and out of hospital to day 180. The~     effect of the intervention on mortality, physical, cognitive and Psychological function at~     180 days, as well as cost-effectiveness of the intervention, will also be evaluated. The~     study will also explore process of care measures and baseline physiology and ICU mobility~     outcomes.~      The hypothesis is that, in ICU patients expected to require prolonged IMV, early activity and~     mobilisation increases the number of days alive and at home to day 180 when compared with~     standard care.~   "
33132|NCT03133364|"~     Meals-on wheels may play a major role in contributing to better nourishment and quality of~     life in older people, thus delaying costly hospitalisation. Still, dwelling, old adults who~     receive meals-on-wheels are a population at risk of undernutrition leading to a decreased~     quality of life.~      Hypothesis Offering nutritious ELDORADO meals as meals-on-wheels to nursing home residents in~     3 months is an effective way to increase quality of life.~      Aim To improve quality of life and functional abilities in nursing home residents by offering~     nutritious ELDORADO meals.~   "
33133|NCT03133351|"~     This study is intended to define the PCM normal laboratory range.~   "
33134|NCT03133338|"~     The investigators aimed to evaluate the effect of early pelvic binder use in emergency~     management of suspected pelvic trauma, compared with the conventional stepwise approach.~   "
33135|NCT03133325|"~     This is a study to assess the safety of GP0045 compared to Restylane Lyft Lidocaine.~      There is a 12-week follow-up period. AEs will be recorded throughout the study.~   "
33136|NCT03133312|"~     Primary Hypothesis: chlorhexidine gluconate antiseptic vaginal preparation is superior to~     povidone-iodine vaginal preparation in decreasing the bacterial load within the vagina when~     prepping prior to a cesarean section.~   "
33137|NCT03133299|"~     Allergic bronchopulmonary aspergillosis (ABPA) is a immunological pulmonary disorder caused~     by hypersensitive reaction to spores of Aspergillus fumigatus. The prevalence of disease is~     about 1-2% in asthmatics and 2-15% in patients with cystic fibrosis. The interest in ABPA~     stems from the fact that the disease is glucocorticoid-sensitive and early treatment can~     prevent progression to end-stage lung disease. Recently anti-Th2 therapies have been~     suggested as treatment for ABPA. Vitamin D has been shown to suppress the Th2 responses and~     decrease the levels of Th2 interleukins. Hence, the investigators propose to assess the role~     of vitamin D in treating ABPA.~   "
33138|NCT03133286|"~     Collect blood samples and associated clinical data prior to, during, and post radiation~     treatment.~   "
33139|NCT03133273|"~     Currently, chemotherapies are empirically administered to patients treated for colorectal~     cancer (CRC). Selection is based on the efficacy of a protocol previously determined on the~     largest number (consensus treatment), the decision-making process being weighted by patient's~     intrinsic criteria. However, each patient is unique, due to the inter- and intratumoral~     heterogeneity inherent in any cancer, partly explaining the unsatisfactory response rates~     observed for available chemotherapies. Functional sensitivity tests offer the possibility to~     adapt the treatment to each patient: they are based on an ex vivo study of the responses of~     the tumor cells (survival / death) to the different molecules / therapeutic combinations~     (chemotherapy or targeted therapy) likely to be administered to the patient. This response,~     translated into a tumor-specific sensitivity profile, can be used by the clinicians to~     determine the most appropriate therapeutic protocol. By increasing the therapeutic efficacy~     from the first line and reducing the deleterious side effects associated with multiple drug~     cycles, the sensitivity test transforms the consensus approach into personalized medicine,~     providing patients with improved progression free survival (PFS) associated with an~     improvement in the quality of life. Oncomedics has developed Oncogramme®, a CE-labeled in~     vitro diagnostic medical device that has already demonstrated the ability to predict~     chemosensitivity in a recent pilot study of metastatic CRC (prediction with 84% chance of~     success of tumor sensitivity to chemotherapy, vs. 50% maximum for chemotherapy administered~     according to the consensus method). The hypothesis that patients treated with a metastatic~     CRC for which systemic chemotherapy is adapted using Oncogramme® have better response rates,~     PFS and quality of life than patients treated according to usual practice, with optimization~     of the costs of care. To our knowledge, this is the only fully standardized test available,~     where each step and reagents of the procedure are mastered. The reliability of the procedure~     makes it possible to render a personalized result for each patient in 97% of the cases. In~     addition, the analysis is specifically centered on tumor cells using a method using fully~     defined, developed and validated media and reagents for each cancer, including CRC. The~     method of revealing the effect of the therapies identifies the proportion of dead cells in~     each condition, whatever their physiological state (proliferation / quiescence), by~     determining the percentage of living and killed cells, thus ensuring high sensitivity~   "
33140|NCT03133260|"~     Major adverse cardiovascular events are the leading cause of perioperative morbimortality in~     non-cardiac surgery. Perioperative myocardial infarction is usually asymptomatic, with a~     mortality around 10-12%.~      Myocardial Injury in Noncardiac Surgery (MINS), is defined as a myocardial injury that~     provokes a troponin increase due to myocardial ischemia. MINS is a predictor of~     morbimortality at short term and at long term.~      The aim of the study is to improve the diagnosis of myocardial injury after non cardiac~     surgery in high-risk patients, improve its treatment in case of MINS and establish prevention~     strategies.~   "
33141|NCT03133247|"~     In many types of human tumors, PD-L1 is highly expressed. Such high expression has often been~     associated with poor prognosis in cancer patients. SHR-1316 is a humanized IgG4 monoclonal~     antibody that binds specifically to human PD-L1.~   "
33142|NCT03133234|"~     To assess the effectiveness and safety of osimertinib treatment in a real world setting.~   "
33143|NCT03133221|"~     This is a pilot study to learn how safe and how effective the study drug Zydelig works, after~     autologous stem cell transplant as a maintenance therapy in patients with indolent or~     transformed indolent B-cell non-Hodgkins lymphoma (iNHL or tiNHL).~   "
33163|NCT03132961|"~     Persons exposed to infrasound - frequencies below 20 Hz - describe a variety of troubling~     audiovestibular symptoms, but the underlying mechanisms are not understood. Recent animal~     studies, however, provide evidence that short-term exposure to low frequency sound induces~     transient endolymphatic hydrops. The existence of this effect has not been studied in humans.~     The long-term objective of this research is to identify a possible mechanism to describe the~     effects of infrasound on the human inner ear. The central hypothesis of the proposed study is~     that short-term infrasound exposure induces transient endolymphatic hydrops in humans. This~     will be tested by performing electrophysiologic tests indicative of endolymphatic hydrops~     among normal hearing individuals before and immediately after a period of infrasound~     exposure. Recordings of infrasound generated by wind turbines in the field have been~     established and calibrated by this team of engineers, otologist, and hearing and balance~     scientists. An infrasound generator reproduces the acoustic signature based on these field~     recordings. Aim 1: Determine the effect of infrasound on the summating potential to action~     potential (SP/AP) ratio on electrocochleography (ECoG). Hypothesis 1: Infrasound exposure~     will cause a reversible elevation of the SP/AP ratio. Aim 2: Determine the effect of~     infrasound on the threshold response curves of ocular and cervical vestibular evoked myogenic~     potentials. (oVEMP and cVEMP). Hypothesis 2: Infrasound exposure will cause elevation of the~     oVEMP and cVEMP thresholds at the frequency of best response. Successful completion of the~     aims will provide evidence for a possible mechanism of the effect of infrasound on the inner~     ear. This understanding will benefit individuals exposed to environmental infrasound and~     those in regulatory, research, and advocacy roles when crafting interventions and future~     policy.~   "
33144|NCT03133208|"~     Sepsis associated encephalopathy (SAE) is a poorly understood acute cerebral dysfunction that~     frequently appears in the setting of sepsis induced systemic inflammation. In fact, altered~     mentation is recognized as an independent predictor of death and poor outcomes in patients~     with sepsis. SAE may be manifested by a number of symptoms characterized by a change in~     baseline behavior, attention, alertness, cognition, or executive functioning. It occurs in~     the absence of direct Central Nervous System (CNS) infection, and the exact pathophysiology~     is of SAE is unknown, but theoretically seems to encompass a constellation of mechanisms such~     as impairment of the blood brain barrier (BBB), endothelial dysfunction, alteration in~     cerebral blood flow and neurotransmission, circulating inflammatory mediators, cellular~     hypoxia, and metabolic disturbances, that ultimately result in neuronal dysfunction and cell~     death. SAE is characterized by an altered mental status (AMS) that ranges from delirium to~     coma, and can lead to long-term cognitive impairment. SAE may appear early in the course of~     sepsis, and is often underestimated as an independent factor of mortality, yet the~     pathophysiology of SAE remains unknown, and there is a lack of specific investigations~     available to clinicians. Studies have evaluated biomarkers as prognostic tools. The~     Investigator propose to measure neuron specific enolase (NSE), S-100B, glial fibrillary~     acidic protein (GFAP), ubiquitin C-terminal hydrolase L1 (UCH-L1), Tau protein, Copeptin,~     spectrin breakdown products (SBDP 145, SBDP150), αII-spectrin N-terminal fragment (SNTF),~     neurofilament light and heavy chains (NF-L, NF-H), myelin basic protein (MBP), secretoneurin~     (SN), and other peptide levels in the serum of sepsis patients who develop altered mental~     status, to evaluate the kinetics of said biomarkers for 72 hours. The Investigator will~     monitor the course of the patients' hospitalization to determine whether there are biomarker~     correlates with survival and outcomes, including neurologic impairment. Finally, this~     investigation may provide a mechanistic pathway that defines the development of AMS in septic~     patients.~   "
33145|NCT03133195|"~     Phase III, prospective, randomized, parallel, double blind, placebo-controlled study to~     determine whether Teriparatide can accelerate bone healing in unstable intertrochanteric~     fracture patients treated with Proximal Femoral Nail Antirotation (PFNA) assessed by~     radiographic and clinical outcomes.~   "
33146|NCT03133182|"~     This study investigates the association of preoperative polypharmacy with outcomes and~     healthcare resource utilization in a population-based sample of older patients enrolled in a~     universal pharmacare program~   "
33147|NCT03133169|"~     The study will investigate the relation between erythrocyte glutamine/glutamate ratio and~     pulmonary hypertension risk in Egyptian thalassemic children in Assiut University Children~     Hospital~   "
33148|NCT03133156|"~     The purpose of this study is to determine whether exercise training leads to changes in the~     white adipose tissue that are beneficial to the body's regulation of sugar and body weight.~   "
33149|NCT03133143|"~     The investigators aim to establish a research project to test the impact of gaming by~     carrying out a video gaming interventions, monitoring its cognitive and clinical outcomes,~     while concurrently performing a multimodal brain imaging experiment.~   "
33150|NCT03133130|"~     Phase I Study to Investigate the Pharmacokinetics, Safety, and Tolerability of BMT101 in~     Healthy Male Volunteers~   "
33151|NCT03133117|"~     The main objective of this research is to study the cognitive and cerebral mechanisms of the~     integration of central and peripheral visual information during normal and pathological aging~     (ophthalmological patients with AMD and glaucoma) through fMRI studies. To assess the effect~     of normal aging, research will be conducted on a group of young participants with normal~     vision and a group of elderly participants with normal vision. Each participant will be~     assessed once during an MRI (during which the brain activity and behavioral performance will~     be measured). In order to evaluate the effect of pathological aging, research will be~     conducted on AMD patients, glaucomatous patients, and age-matched controls (normal vision),~     evaluated only once during an MRI examination.~   "
33152|NCT03133104|"~     This study will review records of women who broke their water early who received a repeat~     course of antenatal steroids.~   "
33153|NCT03133091|"~     Randomized single blind trial based on comparing the way the local anesthetic is dosificated~     during labour. The pain control is evaluated and compared with both dosage techniques (PCEA~     vs PIEB)using levobupivacaine and fentanyl. The primary objective is to see no differences in~     pain control(VAS, Visual Analog Scale). The secondary goals are the differences in motor~     block(Bromage Scale), satisfaction (Likert Scale), the outcome (eutocic, instrumental o~     cesarean section), second stage of labour time, newborn´s Apgar and pH and total dosis and~     secondary effects of local anesthetic.~   "
33154|NCT03133078|"~     The purpose of this study will be to determine the effects of a 2-minute single limb lateral~     step-down fatigue test versus a 30 second side hop test on single limb forward hop distance.~   "
33155|NCT03133065|"~     The study aimed to present our experience in treating recurrent HCV genotype 4 infection post~     living donor liver transplantation (LDLT) since introduction of the second generation direct~     acting antiviral drugs (DAAs) in Egypt.~   "
33156|NCT03133052|"~     This study evaluates the efficacy and mechanism of internet-based cognitive control training~     on episodic memory function in patients with amnestic Mild Cognitive Impairment(aMCI). Half~     of participants will receive adaptive internet-based cognitive control training program,~     while the other half will receive a fixed, primary difficulty level task.~   "
33157|NCT03133039|"~     The investigators sought to determine whether bioabsorbable cannulated screws could perform~     as well as titanium cannulated screws in the Lapidus procedure and MTP1-joint arthorodesis in~     anatomical models and clinical series of the foot.~   "
33158|NCT03133026|"~     Primary Objective: To document state-of- the-art multi-modality management of occluded~     biliary SEMS aiming to minimize number of reinterventions while providing symptom relief~     without procedure-related serious adverse events.~      NOTE: This study will be hypothesis-generating for an anticipated randomized controlled study~     (RCT) to compare outcomes of placement of a plastic stent inside the occluded SEMS to~     outcomes of the proposed multi-modality approach.~   "
33159|NCT03133013|"~     The purpose of this study is to test the ability of a brainwave measurement device~     (SLEEPSCOPE) in identifying and assisting in the diagnosis of depression. The brainwave data~     from individuals with untreated depression and healthy participants will be collected and~     analyzed. The ability to obtain brainwave data from individuals in their homes while they're~     sleeping would represent a significant advance in depression research.~   "
33160|NCT03133000|"~     Prospective non-randomized observational register study of all elective symptomatic~     incisional hernias operated on in the Hernia Center of Reference of Gross Sand Hospital using~     the novel endoscopic assisted Mini- or Less-Open Sublay technique. The data of all patients~     were prospectively documented in the German Hernia Registry Herniamed. The novel~     MILOS-technique allows the minimal invasive implantation of large extraperitoneal meshes for~     the treatment of primary and secondary incisional hernias.~   "
33166|NCT03132922|"~     This study will investigate the safety and tolerability of MAGE-A4ᶜ¹º³²T cell therapy in~     subjects who have the appropriate HLA-A2 tissue marker and whose urinary bladder, melanoma,~     head and neck, ovarian, non-small cell lung, esophageal, gastric, synovial sarcoma, or~     myxoid/round call liposarcoma (MRCLS) tumor has the MAGE-A4 protein expressed. This study~     will take a subject's T cells and give them a T cell receptor protein that recognizes and~     attacks the tumors.~   "
33167|NCT03132909|"~     The sick doctor is a patient apart. His right of prescription and his knowledge of semiology~     easily lead him to self-medication. Several factors linked to his profession may also lead to~     a delay in care: overworking with schedules that are not compatible to organize follow-up,~     poor access to prevention or occupational medicine for liberal doctors but also modesty And~     ashamed of being sick (and especially unfit to heal). Specialized centers and specific~     training courses concerning burnout, addictions and psychiatric pathologies of doctors are~     currently emerging.~      To look after a colleague also seems to imply certain specificities like the sharing of~     knowledge or the medical vocabulary. The physician-patient relationship may seem easier, but~     it can also lead to confusion of roles and create ambiguity. In this case, the doctor may~     feel too close to the doctor-patient to maintain his objectivity and to treat him properly.~     In the same way, the relationship of trust can be altered by sharing medical knowledge,~     communication techniques or confidence building which can thus lose their effectiveness.~      This physician-caregiver relationship has already been the subject of some qualitative~     research demonstrating the difficulty from the point of view of the treated. The feelings and~     attitudes of the doctor caring for his colleague remains a field very little studied. The~     research hypothesis is that there are specificities to this relationship.~   "
33168|NCT03132896|"~     ROSETTA is a multi-centre study evaluating the time course of diaphragm thickness and~     function following exposure to neuromuscular blockade or control in patients with acute~     respiratory distress. ROSETTA is an ancillary study to the Re-evaluation of Systemic Early~     Neuromuscular Blockade (ROSE) trial (NCT02509078). It is designed to (1) test the feasibility~     of a multi-center evaluation of the diaphragm structure and function by ultrasound during~     mechanical ventilation and (2) determine whether neuromuscular blockade accelerates atrophy~     and dysfunction of the diaphragm in patients with acute respiratory distress syndrome (ARDS).~   "
33169|NCT03132883|"~     Transbronchial puncture is a technique known for many years with the first description found~     in 1949 by Shieppati. Subsequently, this technique allowing an exploration of the mediastinal~     lymph nodes became widespread with the work of Wang in 1983. However, the need to have exact~     knowledge of the different puncture sites in order to obtain maximum profitability with this~     examination in particular In staging and diagnosis in bronchopulmonary cancers (CBP) explains~     a significant difference in profitability between operators based on their experience. It was~     not until 1990 that Germans coupled the technique of radial ultrasound with that of~     bronchoscopy by introducing a balloon catheter inflated with a liquid allowing the best~     transmission of ultrasound. It is the German team of Herth who developed this technique in~     1999 under the name of bronchial echo-endoscopy (EBUS). The association of echo-endoscopy~     before transbronchial punctures significantly improves the performance of the examination. In~     2004, Yasufusu shows the interest of the real-time visualization of the lymph nodes for the~     marking as well as the punctures. Therefore, the indications for bronchial echoendoscopies~     with transbronchial needle puncture (EBUS-PTBA) are precisely defined in the nodal staging of~     CBP with good profitability and a reduction in surgical mediastinoscopy. Then, over time,~     there is an extension of indications with the diagnosis of Non-Small Cell Lung~     Broncho-Pulmonary Cancers (NSCLC) or Small Cell Broncho-Pulmonary Cancers (CBPC), the~     diagnosis of ganglion metastases of extra-thoracic primary tumors , Diagnosis of sarcoidosis~     or other more anecdotal uses (tuberculosis, lymphoma).~      Two Picard centers were among the first in France to be equipped with echoendoscopes (2007~     for the CH of Saint Quentin and 2008 for the CHU of Amiens). This allows our two centers to~     have a fairly consistent retreat on the technique since its implantation in France. While~     many studies are concerned with one or other indication in isolation, there is no study to~     the best of our knowledge relating the evolution over time of the respective share of each of~     these indications in daily practice . Given the current multiplication of potential~     indications for EBUS-PTBA, it seems interesting to analyze the place of these new indications~     in the daily activity of endoscopic centers equipped with an echo-endoscope. The main~     objective is to evaluate the respective share of each indication over time over the study~     period. Secondary objectives are the evaluation of the diagnostic performance of EBUS-PTBA,~     the evaluation of the abusively carried-out EBUS-PTBA (examination carried out for purely~     diagnostic purposes, whereas conventional bronchial fibroscopy Diagnosis of certainty) and~     evaluation of concordance between EBUS-PTBA and surgery in CBP staging indications.~   "
33170|NCT03132870|"~     The diagnosis of nodules and peripheral lung masses (lesions not accessible in classical~     bronchial endoscopy) is a challenge for the pulmonologist especially when these lesions are~     not accessible to the transparietal aspirate under scanner. The overall sensitivity of~     flexible fibroscopy for peripheral lesions is 69% (bronchial brushing, transbronchial~     biopsies, bronchoalveolar lavage and blind trans-mucosal aspiration). This sensitivity varies~     from 33% when the lesion is less than 2 cm, to 62% when it is greater than 2 cm. The puncture~     under scan of these lesions remains the gold standard. In the meta-analysis of Schreiber G et~     al., The diagnostic sensitivity of transparietal aspirate for peripheral lung lesions is 90%.~     On the other hand, the complication rate of this technique is not negligible, with in the~     study of Boskovic et al, a pneumothorax rate varying from 8 to 64%. In the literature, the~     only risk factor actually found is the existence of emphysema. However, thoracic drainage is~     rarely necessary.~      Bronchial echo-endoscopy using a radial mini-probe was developed in 1992 by Thomas Hürter and~     Peter Hanrath to produce ultrasound guided specimens of these peripheral lung lesions. In the~     meta-analysis of Steinfort et al., The overall sensitivity of this mini-probe technique is~     73% for the histological diagnosis. From the same author, a randomized trial compared the~     diagnostic sensitivity of transparietal aspirate undergoing ultrasound-guided transbronchial~     biopsy with a radial mini-probe: this was 93.3% versus 87.5% with no significant difference~     (p = 1 ), Whereas post-procedure complications are less frequent in the ultrasound procedure~     (27% versus 3%, p = 0.03). Steinfort also showed that the economic cost of bronchial~     echo-endoscopy by radial mini-probe and transthoracic puncture under CT was similar both to~     the success or failure of the first procedure requiring further investigations .~     Mini-probe-guided specimens are therefore an efficient diagnostic alternative to obtain a~     histological diagnosis of these peripheral lung lesions~   "
33171|NCT03132857|"~     In 2010, the French population over 75 years of age was 9%; It will be 13% in 2030 and 19% in~     2050 according to estimates. The incidence of falls is high in the elderly population, with~     at least one fall per year for one-third of the over-65s and for half of the over-80s. These~     data are consistent with the international medical literature, particularly in Japan, the~     United States and France, with a high rate of recurrence from the first fall. Falling is a~     complex phenomenon that is of great importance in terms of morbidity and mortality since it~     can be followed by serious complications: failure to recover, recurrences, trauma (fractures,~     hematomas, wounds), complications of decubitus and ulcers, Immobilization, loss of autonomy,~     hospitalization, institutionalization, psychological complications (post-fall syndrome,~     depressive syndrome), death.~      Fall risk factors are well known and described and relayed by learned societies of geriatrics~     and medical literature. In addition, HAS reported on this issue in 2009.~      The French Society of Geriatrics and Gerontology (SFGG) defines fragility as a clinical~     syndrome that reflects a decrease in reserve physiological capacities that alters the coping~     mechanisms of stress. Its clinical expression is modulated by comorbidities and~     psychological, social, economic and behavioral factors. Frailty syndrome is a risk marker for~     mortality and pejorative events, including disability, falls, hospitalization and~     institutionalization. The fall and its complications are closely related to the fragility~     syndrome. The very fragile patient must take an active part in his own care. He is the first~     advocate of fall prevention.~      On the other hand medical desertification and the low number of geriatricians makes this~     implication problematic even more so if the person is isolated or has cognitive impairment.~     Nevertheless, it is important to make the patient actor of his own prevention. This is the~     first study to describe the knowledge of older adults about their own risk of falling.~   "
33414|NCT03129672|"~     The study show the clinical results of limb salvage for primary malignant bone tumor of the~     distal tibia using block excision of the tumor and reconstruction with allograft arthrodesis~     with different methods of fixation (plates or intramedullary nail system)~   "
33172|NCT03132844|"~     In France, the vaccination coverage of seniors is clearly deficient. It seems to be a~     cultural specificity, dating back more than 100 years, and which does not exist in~     Scandinavia, nor in much of the Anglo-Saxon world. Only influenza vaccination is a success~     for seniors. The high public health council sets the objective of immunization coverage in~     patients over 65 years of age to 80% whether or not the patient is benefiting from an~     exonerative ALD. The data collections carried out with the various pension funds objective~     have a lower immunization coverage with a rate ranging from 48.8 to 64%. Thus any medical~     consultation should be an opportunity to update the vaccination schedule of adults and the~     elderly.~   "
33173|NCT03132831|"~     Reducing the length of stay (LOS) after primary arthroplasty is a relatively new target that~     arouses the attention of orthopedic surgeons in order to return home early through the fast~     recovery protocols but this goal is also wanted in public health for the sake of overall~     decline health spending in public costs.~      Reducing the LOS after primary hip arthroplasty and knee is studied through many publications~     that found an LOS influenced by the own medical factors of patients (ref) However, no study~     to our knowledge research the influence of the operative day and the LOS.~      For historical reasons, the organization of care is modified on the weekend (Saturday and~     Sunday) in particular by reducing the caregiver and also the lack of physical therapist to~     make the early postoperative get up (D0 or D1).~      The hypothesis is that a patient operated the friday did not have the same care the first 48~     hours that a patient who had surgery at the beggening of the week and that his recovery was~     therefore extended.~      The investigator can also suppose that LOS was shorter for patients returning home for those~     who were transferred to a rehabilitation center or other structure.~      The results will be adjusted according to the literature data on the age more than 80 years,~     sex, diabetes, cardiovascular diseases, respiratory diseases.~   "
33174|NCT03132818|"~     Sexual disorders associated with medical aid for procreation have already been demonstrated~     in several studies. However, few of them are interested in the problem of patients in charge~     of donating gametes, and if studied, it is often restricted to donating sperm to a small~     number of patients. For this reason, it would be interesting to study the impact of the~     intake and in charge and the treatments of the Medical Aid to the Procreation on this~     population of patients (including the patients treated in donation of sperm but also Those~     supported in oocyte donation)~   "
33175|NCT03132805|"~     In this study, the investigators propose to examine whether the combination of a universal,~     elementary school-based preventive intervention with an indicated preventive and treatment~     intervention would yield greater impact on aggression than the universal preventive~     intervention alone.~   "
33176|NCT03132792|"~     This first time in human study is intended for men and women at least 18 years of age who~     have advanced liver cancer which has grown or returned after being treated. Those who did not~     tolerate or refused other therapies may also participate. The purpose of this study is to~     test the safety of genetically changed T cells that target alpha-fetoprotein (AFP) and find~     out what effects, if any, they have in subjects with liver cancer. This study is for subjects~     who have a blood test positive for appropriate HLA-A*02 and liver tumor has the AFP protein~     and whose noncancerous liver tissue has very little AFP protein.~      The study will take the subject's T cells, which are a natural type of immune cell in the~     blood, and send them to a laboratory to be modified. The changed T cells used in this study~     will be the subject's own T cells that have been genetically changed with the aim of~     attacking and destroying cancer cells.~      The manufacturing of T cells takes about 1 month to complete. The T cells will be given back~     to the subject through an intravenous infusion after 3 days of chemotherapy. The study will~     evaluate three different cell dose levels in order to find out the target cell dose. Once the~     target cell dose is determined, additional subjects will be enrolled to further test the~     safety and effects at this cell dose.~      Subjects will be hospitalized for at least 1 week after receiving their T cells back and then~     seen frequently by the Study Physician for the next 6 months. After that, subjects will be~     seen every three months. If subjects have disease progression or withdraw from the study,~     they will then be entered into a long-term follow up for safety monitoring. In long-term~     follow up, subjects will be seen every 6 months by their Study Physician for the first 5~     years after the T cell infusion and annually for the next 10 years.~   "
33177|NCT03132779|"~     Evaluating the effect of intralipid on the natural killer cells~   "
33178|NCT03132766|"~     This study will employ a SMART design to evaluate the effectiveness of New Hope (NH), Elders'~     Resilience intervention (ER), Case Management (CM) and the combination of these approaches on~     reducing suicidal thoughts and promoting resilience among AI youth ages 10-24 who are~     identified by a surveillance system as having recent suicide ideation or behaviors or binge~     substance use. This five-year study tests a sequence of novel preventive strategies that~     American Indian (AI) tribes can use to sustainably reduce the burden of AI youth suicide and~     promote resilience. The study will evaluate the effectiveness of task-shifting the~     administration of interventions to culturally embedded paraprofessionals. The Johns Hopkins~     Center for American Indian Health (CAIH) will provide research oversight and the White~     Mountain Apache Tribe (WMAT) will be the primary study site. Navajo Nation (NN) will~     participate as a secondary site in years 4-5. The study investigators hypothesize that: a)~     New Hope vs. Case Management alone will significantly reduce participant suicidal ideation;~     b) Elders Resilience vs. Case Management alone will significantly improve participant~     resilience; c) New Hope followed by Elders Resilience will have the strongest effects on~     suicidal ideation and resilience; and d) Case Management alone will have the weakest effects~     of all combinations.~   "
33195|NCT03132545|"~     In a longitudinal, prospective and observational study, patients with PCOS and controls wore~     the SenseWear Armband for 2 days. Resting metabolic rati (kcal/die), total energy expenditure~     (MET, kcal) were evaluated. Ultrasonographic pelvic examinations, hirsutism score,~     anthropometric and menstrual pattern evaluation, hormonal profile assays, oral glucose~     tolerance test (OGTT) and lipid profile were performed.~   "
33196|NCT03132532|"~     This study is being done to study which dose of proton beam therapy (PBT) for unresectable~     stage 2/3 Non-Small Cell Lung Cancer.~   "
33197|NCT03132519|"~     Pain, cough, hypertension and tachycardia are frequent events during extubation due to a~     secondary stimulation of mechanoreceptors located in the airway. The mechanical effect of the~     endotracheal tube activates autonomic reflexes, a situation that could potentially impair the~     clinical condition of patients. Previous studies have used remifentanil during emergence and~     extubation showing good results to control this reflex response. However, it is unknown so~     far, the optimal effect site concentration (Ce) of remifentanil to allow a better control of~     these events with a low incidence of adverse effects after have received inhaled anesthesia~     plus remifentanil for anesthetic maintenance. This study will determine the Ce of~     remifentanil associated with a lower proportion of cough and hyperdynamic circulatory~     response during extubation for emergency after exposure to sevoflurane or desflurane.~   "
33179|NCT03132753|"~     The investigators seek to develop and assess the effectiveness of Substance Use Programming~     for Person-Oriented Recovery and Treatment (SUPPORT), a community-driven recovery-oriented~     system of care for individuals recently released from prison. SUPPORT is modeled after~     Indiana Access to Recovery (ATR), a program that operated between October 2007 and December~     2014. ATR, a national initiative funded by the Substance Abuse and Mental Health Services~     Administration (SAMHSA), provided comprehensive, flexible, recovery-oriented services for~     substance use disorder (SUD). The investigators' local evaluation of this program~     demonstrated significant improvement in a number of recovery-related outcomes (e.g.,~     substance use, employment, income, involvement in the criminal justice system, and emotional~     well-being) for clients between intake and discharge. Additionally, qualitative findings from~     this evaluation demonstrated ATR was well liked among clients and providers. While Indiana~     ATR did serve a wider range of clients, the investigators have focused SUPPORT on returning~     inmates because (a) this was the largest group served by the program and (b) there is~     significant need for evidence-based SUD interventions for this population.~      The investigators' primary long-term goal is to establish an effective and scalable~     recovery-oriented system of care for SUD within the reentry population. The investigators~     will conduct a pilot test comparing SUPPORT clients to clients receiving usual treatment. The~     investigators will collect quantitative data for both groups at multiple time points to~     understand the intervention's impact on recovery capital and outcomes and will collect~     qualitative data from SUPPORT clients to better understand their program and post-discharge~     experiences.~   "
33180|NCT03132740|"~     The aim of the multi-centre study is to evaluate correctly the impact of three dimensional~     visualization on operation strategy and complications for complex hepatic carcinoma.~   "
33181|NCT03132727|"~     To determine if MRI can detect preoperative invasion of cartilage by laryngeal and~     hypopharyngeal carcinoma, and to compare it to CT imaging and histopathology in excised~     larynges and/or hypopharynges.~   "
33182|NCT03132714|"~     The aim of this project is to compare the efficacy and the local effect of the association of~     single or repeated application of photodynamic therapy (PDT) with antibiotic agents using~     Amoxicillin + Metronidazole or Clarithromycin in the treatment of patients with Generalized~     Aggressive Periodontitis (GAgP).~   "
33183|NCT03132701|"~     Evaluation of prevention of emergence delirium and analgesic effect of magnesium on children~   "
33184|NCT03132688|"~     This retrospective study the safety and efficacy of intravenous propofol used in children~     under 2 years of age during general anesthesia for surgery.~   "
33185|NCT03132675|"~     This will be a Phase 2 study of intratumoral pIL-12-EP plus IV pembrolizumab. Eligible~     patients will be those with pathological diagnosis of unresectable or metastatic melanoma who~     are progressing or have progressed on pembrolizumab or nivolumab..~   "
33186|NCT03132662|"~     A recent review demonstrated that Non-alcoholic fatty liver disease (NAFLD) affects 10-35% of~     the adult population worldwide, with the prevalence approaching 85-100% in obese populations.~     Current standard treatment for liver reduction before surgery is the use of a very low~     calorie liquid diet (VLCLD). Multiple studies have shown that a 2-4 week diet with a VLCD~     will reduce liver volume, in preparation for surgery. Omega-3 (Ω-3) polyunsaturated fatty~     acids (PUFAs) have been suggested as a treatment for NAFLD. The primary aim of this study is~     to compare Ω-3 PUFAs and a VLCLD and their effect on left lobe live size before bariatric~     surgery.~   "
33187|NCT03132649|"~     The aim of the multi-centre study is to evaluate correctly the impact of three-dimensional~     visualization on operation strategy and complications for hilar cholangiocarcinoma.~   "
33188|NCT03132636|"~     The primary objective is to estimate the overall response rate (ORR) for metastatic Basal~     Cell Carcinoma (BCC) (group 1) and for unresectable locally advanced BCC (group 2) when~     treated with REGN2810 as a monotherapy~   "
33189|NCT03132623|"~     A multicenter, randomized, double-blind, placebo-controlled, phase 4 clinical trial to~     evaluate the efficacy and safety of andrographolide sulfonate in patients with acute~     bronchitis~   "
33190|NCT03132610|"~     A multicenter,randomized,single-blind, placebo-controlled,phase 4 clinical trial to evaluate~     the efficacy and safety of andrographolide sulfonate in patients with acute exacerbation of~     chronic bronchitis~   "
33191|NCT03132597|"~     Studies show a high number of medical students suffering from mental health problems.~     Although there are several studies investigating how these problems could impact students'~     life and performance, few studies have investigated interventions to minimize this distress.~     One of these interventions is the mindfulness meditation, that has already been extensively~     studied in the scientific literature showing promising results. Nevertheless, there are very~     few studies which investigated how mindfulness could be implemented as a mandatory course.~     The present study aims to investigate (1) how students exposed to mindfulness differ from~     students not exposed to this technique concerning their mental health and quality of life in~     a short and long term period. This is an intervention protocol using a randomized controlled~     clinical trial with cross-over, in order to compare if the implementation of mindfulness for~     first year medical students will improve their mental health and quality of life in the short~     term (3 months). The intervention group (group 1) will be exposed to mindfulness in the~     beginning of the medical course and will be compared to a control group (group 2), not~     exposed to mindfulness (exposed to theoretical classes) for 3 months. After that, the~     intervention group (group 1) will receive theoretical classes and the control group (group 2)~     will be exposed to the mindfulness techniques for 3 months (cross-over). Therefore, both~     groups will be exposed to mindfulness in the first year of undergraduation, however in~     different moments of the course. Then, these first year medical students (groups 1 and 2)~     will be compared to another class (group 3), which didn't have this mindfulness mandatory~     course in their formation. They will be compared after 6 months, 12 and 24 months of~     intervention (long-term effect).~   "
33192|NCT03132584|"~     This research study is studying a combination of chemotherapy drugs as a possible treatment~     for aggressive lymphoma that has not responded to standard treatment.~      The names of the study interventions involved in this study are:~        -  Cyclophosphamide~        -  Alemtuzumab~   "
33198|NCT03132506|"~     Evaluation of patient acceptance and characterization of response behaviour for web-based~     compared with respective paperbacked patient reported outcomes.~   "
33199|NCT03132493|"~     The investigators will be retrospectively review the case note of patients registered in the~     EAP of Nivolumab.~      A standard anonymous data collection form will be used to collect data and to analyze it.~      Patients with advanced Non-Small Cell Lung Cancer previously treated and included in the~     SPANISH expanded access programme of nivolumab.~   "
33200|NCT03132480|"~     Forehead sensor can predict the more accurate fluid responsiveness than finger sensor in~     children~   "
33201|NCT03132467|"~     The goal of this clinical research study is to find the highest dose combination of~     tremelimumab and durvalumab [also called MEDI4736]) that can be given before standard of care~     pre-surgery chemotherapy to patients with HR+, HER2- breast cancer. Researchers also want to~     learn more about how certain immune cells may change in the body when they are given the drug~     combination. Researchers also want to find out how patients with HR+, HER2- breast cancer~     respond to the study drugs before they receive standard chemotherapy treatment.~      This is an investigational study. Tremelimumab is FDA approved to treat mesothelioma.~     Durvalumab is FDA approved to treat a certain type of bladder cancer. It is investigational~     to give these 2 drugs in combination to patients with HR+, HER2- breast cancer. The study~     doctor can describe how the study drugs are designed to work.~      Up to 15 participants will be enrolled in this study. All will take part at MD Anderson.~   "
33202|NCT03132454|"~     Any time the words you, your, I, or me appear, it is meant to apply to the potential~     participant.~      The goal of this clinical research study is to learn more about the safety and effects of~     palbociclib, when given alone and then in combination with different standard drugs to~     patients with leukemia that is relapsed (has come back) or refractory (has not responded to~     treatment). The standard drugs being used are sorafenib, decitabine, and dexamethasone.~     Different doses of the standard drugs will be tested.~      Researchers will also be performing research tests, such as biomarker, pharmacodynamic (PD),~     and cytogenetic testing. Biomarkers are found in the blood/tissue and may be related to your~     reaction to the study drug. The biomarker testing in this study will include genetic~     biomarker testing. PD testing measures how the level of study drug in your body may affect~     the disease. Cytogenetic testing looks at how genetic changes to cells may affect how the~     disease may react to the study drug.~      This is an investigational study. Palbociclib is FDA approved and commercially available to~     treat a type of breast cancer when used in combination with other drugs. Sorafenib is FDA~     approved and commercially available to treat renal cell cancer or hepatocellular cancer.~     Decitabine is approved for the treatment of myelodysplastic syndrome (MDS). Dexamethasone is~     FDA approved and commercially available for the treatment of numerous medical conditions~     including hematologic disorders such as thrombocytopenia and anemias. It is investigational~     to give palbociclib in combination with sorafenib, decitabine, or dexamethasone to patients~     with leukemia.~      The study doctor can explain how the study drugs are designed to work.~      Up to 54 participants will be enrolled in this study. All will take part at MD Anderson.~   "
33203|NCT03132441|"~     This study is a pilot study evaluating the feasibility and early efficacy of cardiac~     rehabilitation to improve frailty and symptoms in patients with advanced heart failure (NYHA~     class III-IV), who are being considered for LVAD therapy.~   "
33204|NCT03132428|"~     This is a multicenter, prospectively defined, observational registry study evaluating the use~     of inhaled nitric oxide (INOMAX) in 84 Premature (P) neonates (at least 27 weeks but less~     than 34 weeks of gestational age [GA]) and 84 Term-Near-Term (TNT) neonates (at least 34~     weeks to no more than 40 weeks of GA), with Pulmonary Hypertension (PH). The 2 groups will~     have a similar number of subjects by severity (mild, moderate, and, severe) and evaluated for~     response to INOMAX during a treatment period of up to 96 hours ± 12 hours and a safety~     follow-up through 7 days (for a total of up to 11 days) or to hospital discharge, whichever~     comes first.~   "
33205|NCT03132415|"~     Get Connected (GC) is an online brief intervention that employs individual and systems-level~     tailoring technology to reduce barriers to HIV prevention care (e.g., HIV/STI testing, PrEP)~     for YMSM. The deployment of GC through a mobile-friendly WebApp seeks to optimize online~     interventions' acceptability, accessibility, availability, long-term affordability among~     youth. The investigators will enroll 480 self-reported HIV-negative or sero-status unaware,~     sexually active YMSM (ages 15-24) across three cities and randomize them into the GC~     intervention condition or to an attention-control condition. Assessments will be collected at~     30 days and at 3, 6, 9 and 12 month follow-up.~   "
33206|NCT03132402|"~     Elimination of P. falciparum (PF) malaria across a territory requires universal access to~     treatment of clinical cases for communities, and specific targeting of places or population~     groups where malaria transmission persists in spite of generalized access to treatment. In~     particular, a large prevalence of carriers of PF parasites is suspected to be one of the~     reasons for malaria persistence. The fact that these carriers are not developing symptoms~     allow them to harbour and transmit parasites over long periods of time. They are likely to~     contribute significantly the transmission in their community and even beyond it according to~     their movement patterns.~      Identifying these pockets of high asymptomatic carriage is a key component of the malaria~     elimination strategy, as it allows targeting specific interventions, such as targeted~     mass-treatment, to quickly drain the asymptomatic reservoir.~      Strategically to achieve this goal we need to be able to identify quickly and reliably the~     villages or groups of villages in which the asymptomatic reservoir is large and should be~     addressed by targeted mass drug administration (MDA).~      There are no point of care tests currently available to detect asymptomatic carriers~     accurately. The available Rapid Diagnostic Tests (normal RDT) are designed to diagnose~     clinically relevant malaria infections. However their sensitivity for asymptomatic malaria~     carriers is low, since most of these individuals harbor parasitaemias below RDT detection~     thresholds. Currently, we are relying on high volume blood surveys, in which a small sample~     of the village population provides a 2mL venous blood sample that can be analysed by~     ultra-sensitive qPCR. This technique allows detecting very low parasitaemias. However it is a~     high cost test and technical requirements to use qPCR limit the number of samples that can be~     tested. In addition as the analysis must be done in a laboratory, the time needed for~     shipment and analysis results in delays of 4 to 8 weeks between survey and result. Surveying~     remote, poorly resourced areas adds to the challenge as the samples must be shipped from the~     field to the laboratory, on cold chain, within 24 to 48h from blood draw.~      To ensure that asymptomatic individuals are diagnosed in a cost effect and feasible manner,~     it is vital that a more sensitive RDT is made available for use in the field. Depending on~     its performance, a sensitive RDT could be used for prevalence surveys to target MDA, or~     directly for interventions based on treatment of positive individuals (reactive case~     detection or mass screening and treatment).~      A new hypersensitive RDT (hsRDT) has now been developed but before it can be utilised for~     elimination surveys we need to validate both its technical properties (sensitivity and~     specificity) and its usefulness in the field to detect PfHRP2 presence compared to a gold~     standard control ELISA (Enzyme Linked Immuno-Sorbent Assay) test. This will allow~     confirmation of false- and true- positive among samples.~   "
33207|NCT03132389|"~     In this study the investigators seek to register the prevalence of sexually transmitted~     infections (STI) among people attending the Sexual Assault Centre in Oslo, Norway. The main~     aim of this study is to gather representative data on STIs after sexual assaults.~     Consequently, if the attendance for medical follow up turns out to be good/sufficient,~     prophylactic (antibiotic) treatment can potentially be omitted.~   "
33208|NCT03132376|"~     Background: Consistent data from acute, single preload studies demonstrate improvements in~     perceived appetite and satiety following the consumption of high-protein preloads compared to~     normal protein preloads. However, it is currently unclear as to whether protein quality~     (i.e., protein source) or the use of appetite questionnaires influences these outcomes.~     Objective: To examine whether the consumption of protein preloads (egg white isolate, whey~     isolate, micellar casein, and instant egg white) differentially modulate postprandial hunger,~     fullness, desire to eat, prospective food consumption, eating initiation, and subsequent food~     intake; and if the use of appetite questionnaires to assess perceived appetite and satiety~     affect subsequent energy intake. Methods: Twelve young adults (age: 22±1 y; BMI: 22.1±0.9~     kg/m2) reported to the research facility between 7 - 9 am to complete each 4-h testing day. A~     set of questionnaires assessing perceived hunger, fullness, desire to eat, prospective food~     consumption were completed followed by the consumption of the 130 kcal beverage preloads,~     varying in protein source. A water preload was also included as a control. The same set of~     questionnaires along with the assessment of whether they would like to eat again were~     completed every 30 min throughout the 4-h postprandial period. On a separate day, all twelve~     young adults also completed a similar testing day except were not given questionnaires~     throughout the 4-h postprandial period. After the 4-h, the participants were given an ad~     libitum pasta meal to consume until 'comfortably full.' Results: The consumption of the~     protein preloads improved hunger, fullness, desire to eat, prospective food consumption and~     delayed the request to eat again vs. the control (water); however, no differences in appetite~     and satiety outcomes were observed between protein sources. No differences in energy content~     at the lunch meal were observed between any preloads. The use of questionnaires did not~     change energy consumed at the lunch meal. Conclusions: When comparing high-quality~     animal-based proteins consumed as a beverage preload, relatively no differences in markers of~     appetite control and satiety were detected, suggesting that protein quality has little impact~     on these outcomes when consuming 30g of protein. In addition, the use of questionnaires~     assessing perceived appetite and satiety do not impact subsequent energy intake.~   "
33209|NCT03132337|"~     The goal of this is to learn more about stem cell transplant and complications that some~     people have after their transplants, in particular sinusoidal obstruction syndrome (SOS),~     also called veno-occlusive disease of the liver.~   "
33211|NCT03132311|"~     Phase 4 study to evaluate the immunogenicity and Safety of the 17DD Yellow Fever vaccine in~     HIV infected individuals, compared to non-HIV-infected individuals.~      Main objective:~      To compare the proportion of seroconversion and the geometric mean of neutralizing antibodies~     30 days and 365 days after vaccine.~      Secondary objectives:~      To evaluate whether the titles of neutralizing antibodies are associated with CD4 lymphocyte~     counts, CD8 lymphocyte counts, CD4 nadir, HIV viral load and use of antiretroviral therapy.~     To assess the yellow fever vaccine viremia at day 10 after vaccine.To compare the incidence~     of adverse events in HIV-infected and non-HIV-infected individuals.~   "
33212|NCT03132298|"~     The goal of the project is to test whether a single-session intervention teaching incremental~     theories of personality, or the belief that one's personality is malleable, can strengthen~     recovery from social stress and reduce the development of anxiety and depression during early~     adolescence. Results may suggest a scalable, cost-effective approach to improving youths'~     coping capacities and preventing adverse mental health outcomes over time.~   "
33213|NCT03132285|"~     To assess the safety and acceptability of the non-surgical PrePex device among healthy adult~     male participants scheduled for voluntary medical male circumcision when removing the~     foreskin shortly after device placement.~   "
33214|NCT03132272|"~     Efficacy of immunoadsorption for treatment of persons with Alzheimer dementia and agonistic~     autoantibodies against alpha1A-adrenoceptor.~   "
33215|NCT03132259|"~     Transnasal transsphenoidal (TNTS) resection of pituitary tumors involves wide fluctuation in~     hemodynamic parameter and causes hypertension and tachycardia due to intense noxious stimuli~     during various stages of surgery. None of routinely used anesthetic agents effectively blunts~     the undesirable hemodynamic responses, and therefore usually there is a need to use increased~     doses of anesthetic agents. Dexmedetomidine (DEX) an α-2 adrenergic receptor agonist, because~     its sympatholytic and antinociceptive properties may ensure optimal intraoperative~     hemodynamic stability during critical moments of surgical manipulation. In addition, DEX~     reduced the anesthetic requirement with rapid recovery at the end of surgery. The main aim of~     the study was to evaluate the effect of DEX on perioperative hemodynamics, anesthetic~     requirements~   "
33216|NCT03132246|"~     A prospective trial conducted at Shock Trauma of patients between 18 years of age and older~     who have sustained a fracture with metal implanted. The investigators will be collecting~     between 1-3 routine blood draws for the purpose of laboratory analysis to assess biofilm~     growth. Patients may be infected or non-infected at the time of blood draw; they will be~     selected at random for purposes of this study. All patients will be followed as standard of~     care by their treating physician for all their follow up visits.~   "
33217|NCT03132233|"~     Approx. one billion people are suffering from migraine worldwide and yet, therapeutic options~     are still very limited. Research suggests that changes in energy metabolism could be part of~     migraine pathophysiology. Ketone bodies (KB) are endogenous alternative energy substrates.~     Our clinical trial assesses the efficacy and safety of KB supplements in 60-90 adult~     migraineurs (5-14 migraine days / months) at the University Hospital Basel. The total~     duration of the trial is approx. 6 months, consisting of 4 weeks baseline, 12 weeks~     intervention with KB powder or matched placebo and 8 weeks follow-up. The primary endpoint is~     the change in migraine days at the end of intervention compared to baseline. Additionally,~     changes in gene expression, fat-, and glucose metabolism, inflammatory markers and quality of~     life will be examined.~   "
33218|NCT03132220|"~     Developed over 10 years ago, Mindfulness Based Cognitive Therapy (MBCT) synergistically~     combines mindfulness training and cognitive behavioral therapy and can increase resiliency.~     In this study, the investigators proposed two aims: Aim #1: To adapt and optimize a MBCT~     resiliency program specifically for ICU nurses. For this aim, the investigators will engage~     multiple stakeholder groups to assist the protocol adaptation. Aim # 2: To conduct a pilot~     clinical trial to determine acceptability of the MBCT resiliency program and the control~     intervention. In this aim, the investigators will also identify the most feasible~     randomization level to minimize contamination between the control and intervention groups.~     Collectively, this proposal will pave the way for a properly designed large multi-center~     trial of a MBCT resiliency program (MBCT-ICU) to determine its ability to decrease BOS~     symptoms; and allow nurses to more effectively care for patients in the challenging ICU~     environment.~   "
33219|NCT03132207|"~     Epidemiological studies have suggested that maternal periodontitis affects the~     fetal-placental unit, with an increased risk of adverse pregnancy outcome. Indeed, it has~     been suggested that the direct or indirect action of parodontopathogenic bacteria induces an~     inflammatory cascade that leads to spontaneous premature labor. Also, non-treatment of caries~     and periodontal disease can lead to acute pain and stress. This may promote self-medication~     and the inappropriate use of analgesic medications, potentially harmful to the health of the~     fetus. As part of the prevention of complications of pregnancy associated with oral diseases,~     the National Agency for Accreditation and Evaluation in Health (ANAES) has set up a system~     that allows any pregnant woman to consult between the 4th and 7th month of pregnancy, an oral~     health professional to carry out a complete assessment and free care. This study aims at~     evaluating this device among pregnant women and healthcare professionals 4 years after its~     implementation. On the other hand, it will make it possible to look for a possible link~     between the realization of an oral prenatal follow-up and the outcome of the pregnancy.~   "
33220|NCT03132194|"~     To evaluate the therapeutic effect of DPSG and Placebo gel in the treatment of acne vulgaris.~   "
33221|NCT03132181|"~     SGLT2 inhibitors are a novel class of glucose lowering drugs that act in the kidney by~     inhibiting SGLT2-mediated glucose reabsorption in the proximal tubule. The resulting increase~     in urinary glucose excretion leads to a reduction in plasma glucose levels. This is~     accompanied by reduction of total body weight due to urinary energy loss. In addition,~     glucose dependent osmotic diuresis contributes to blood pressure lowering effects of SGLT2~     inhibition.~      Aim of the trial is to assess hemodynamic changes by empagliflozin, identify new~     empagliflozin dependent metabolic regulators and evaluate empagliflozin dependent effects on~     cardiac function.~   "
33222|NCT03132168|"~     In this study, post-operative delirium will be measured in patients undergoing surgery for~     bladder resection, and associated microRNA biomarkers will be evaluated in patients~     considered delirious and non-delirious after surgery.~   "
33225|NCT03132129|"~     Background: Heart failure is a major cause of morbidity and mortality in diabetes mellitus,~     but its pathophysiology is poorly understood.~      Aim: To determine the prevalence and determinants of subclinical cardiovascular dysfunction~     in adults with type 2 diabetes (T2D).~      Plan: 150 asymptomatic older adults (aged 50-75 years) with T2D will undergo comprehensive~     evaluation of cardiac structure and function using cardiac MRI (CMR) and spectroscopy,~     echocardiography, CT coronary calcium scoring, exercise tolerance testing and blood sampling.~     Fifty controls will undergo the same evaluation.~      Primary hypothesis: myocardial steatosis is an independent predictor of left ventricular~     global longitudinal strain. Secondary hypotheses: will assess whether CMR is more sensitive~     to detect early cardiac dysfunction than echocardiography and BNP, and whether cardiac~     dysfunction is related to peak oxygen consumption.~      Expected value of results: This study will reveal the prevalence and determinants of cardiac~     dysfunction in T2D, and could provide targets for novel therapies.~   "
33226|NCT03132116|"~     To compare effect of intra-nodal injection of gentamicin versus placebo on the outcome at 28~     days of suppurated cat scratch disease's (CSD) lymphadenitis treated by oral azithromycin.~   "
33227|NCT03132103|"~     The purpose of this study is to examine the effect of vitamin D supplementation on vitamin D~     status, immunity and physical performance.~   "
33228|NCT03132090|"~     Therapeutic agents used in malignant melanoma treatment such as BRAF/MEK inhibitors and~     anti-CTLA-4/Anti-PD-1 antibodies go along with harmful side effects in a considerable~     proportion of patients and treatment costs may cause relevant medical expenditures per month.~     Currently, therapy response assessment in melanoma patients is performed using RECIST~     criteria which are based on changes in tumour size. PET/CT combines morphological and~     metabolic information. Thus, the so-called PERCIST-criteria were introduced integrating~     change in size and glucose utilization for response assessment in solid tumors. Due to the~     different mechanism of action these new agents introduce different response patterns increase~     in tumor size due to inflammation for antibody therapies). In conventional chemotherapies,~     re-staging is usually performed 3 months after treatment initiation which is the result of~     empirical investigations. Moreover, it has recently been shown, that response to new targeted~     therapies can be detected much earlier using PET or functional MR techniques. This forms the~     rationale for the monitoring of melanoma patients using a combined PET/MR technique after~     only 2 weeks of therapy initiation. Especially for patients in stage IV with a medium~     survival time of 12 months, a 2.5 months earlier re-staging and therapy adjustment would have~     significant consequences for the individual clinical course.~   "
33229|NCT03132077|"~     The intention is to explore whether there are factors which help us to understand why some~     patient outcomes are not successful and identify prediction factors for progression. It will~     also assess the available outcomes pre- and post-surgery may explore prediction tools for~     good/poor progression and improve the patient's selection, patient preparation or timing for~     surgery.~      The focus of this project is exploring outcomes post-primary total knee arthroplasty (TKA)~     using the available pre/post-operative Oxford Knee Score (OKS), University of California Los~     Angeles (UCLA) Activity Score, EQ-5D General Health Questionnaire, Visual Analogue (VAS) for~     pain, age and smoking status data, and correlations between these data and post operation~     patient satisfaction.~   "
33230|NCT03132064|"~     To explore whether there are factors that help us to understand why some patient outcomes are~     not successful and identify prediction factors for progression. Assess central pain~     sensitisation and psychology pre- and post-surgery with reliable tools that explore~     prediction tools for good/poor progression and improve patient selection, patient preparation~     and timing for surgery.~      The aim of this project is to explore the effects of pre-surgical central pain sensitisation~     on pain and function outcomes post-TKA. Central pain sensitisation will be assessed using~     pressure algometry and the Pain Catastrophizing Scale will be used to explore pain~     psychology. Functional outcomes post-TKA will be assessed using a commonly used scale for~     patients' self-reported outcomes (Oxford Knee Score), visual analogue scale, a star excursion~     balance test and four recommended patient performance-based tests.~   "
33231|NCT03132051|"~     The objective of this study was to assess sonographic changes of the median nerve after~     steroid injection for carpal tunnel syndrome.~   "
33232|NCT03132038|"~     INDICATION:~      Patients with recurrent and/or metastatic salivary glands carcinoma who have progressed~     during the 6 months period before entering the study and who are eligible for nivolumab~     monotherapy.~   "
33233|NCT03132025|"~     To control apatinib and capecitabine combination to maintain treating metastatic colorectal~     cancer.~   "
33234|NCT03132012|"~     This is a pilot randomized controlled trial of an Internet-based skin cancer prevention~     intervention as compared to a standard of care control in 80 non-Hispanic white females ages~     20-30.~   "
33235|NCT03131999|"~     This is a phase 1 clinical trial comparing imatinib mesylate to placebo for individuals with~     lymphangioleiomyomatosis (LAM).~   "
33236|NCT03131986|"~     Since the debut of imatinib, the first tyrosine kinase inhibitor(TKI), more than two decades~     ago, the prognosis of patients with chronic myelogenous leukaemia (CML) has continued to~     improve. It has been shown that life expectancy of CML patients is approaching that of the~     general population nowadays. Currently, indefinite use of TKIs in patients with chronic-phase~     CML who achieve optimal response remains the standard practice. Nevertheless, the concepts of~     treatment-free remission and functional cure have been hotly discussed in recent years. A~     number of major international clinical trials have demonstrated that about 40-60% of CML~     patients who previously enjoyed deep molecular response on TKI manage to stay free from~     molecular relapse after cessation of TKI therapy.~      Local experience of TKI cessation is lacking. This study aims to recruit patients diagnosed~     with CML, chronic phase who are treated with TKIs and remain in stable deep molecular~     response for at least two years. It is planned to stop TKI in these patients with regular~     monitoring, and determine their outcomes.~   "
33237|NCT03131973|"~     Drug-drug interaction study in healthy men and women not of childbearing potential. Assess~     the effect of BMS-986195 on the pharmacokinetics of methotrexate, caffeine, montelukast,~     flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin. Collect data on safety of~     BMS-986195 and methotrexate, caffeine, montelukast, flurbiprofen, omeprazole, midazolam,~     digoxin, and pravastatin. Collect data on multiple-dose pharmacodynamics of BMS-986195.~   "
33238|NCT03131960|"~     This is a pivotal phase study of up to 120 subjects and 15 clinical sites. All subjects are~     implanted with the Vivistim System® and then randomized to either study treatment or~     active-control treatment. The randomization will be stratified by age (<30, >30) and baseline~     FMA UE (20 to <35; >35 to 50). Study treatment is vagus nerve stimulation (VNS) delivered~     during rehabilitation. Active control treatment is rehabilitation (standard-of-care~     treatment) with only a minimal amount of VNS at the start of each session intended to support~     blinding.~   "
33239|NCT03131947|"~     Adult patients > 18 years with fresh (within 2 weeks of injury), closed and open, tibia and~     femur fractures who undergo IM nailing for fracture fixation will be eligible for the study.~     Participants will be recruited over 24 months. Participants will undergo a baseline~     questionnaire, HIV testing and assessment of their BMD. They will be followed up at 6 weeks,~     and 3, 6 and 12 months. All adult patients who develop delayed bone union at 6 month follow~     up will be considered cases. Adult patients who show evidence of radiological union at 6~     months or less will be considered controls.~   "
33240|NCT03131934|"~     This is an open label, non-randomised, multicentre Phase I to determine the safety of~     tacrolimus-resistant autologous EBV-specific cytotoxic T-cells (EBV CTL) and compare their~     expansion/persistence with control EBV CTL in solid organ transplant patients with~     post-transplant lymphoproliferative disease (PTLD). Each patient will receive an infusion of~     two ATIMPs - autologous EBV CTL retrovirally transduced with (a) a calcineurin mutant (CNA12)~     that confers resistance to tacrolimus and (b) a control calcineurin mutant (CNA8).~   "
33241|NCT03131921|"~     This is an observational study to assess the determinants of energy expenditure in cancer,~     and how those change throughout the disease trajectory. The investigators hypothesize that~     skeletal muscle will be the primary determinant of energy expenditure throughout the disease~     trajectory and that sarcopenic individuals will have lower activity levels.~   "
33242|NCT03131908|"~     The goal of this clinical research study is to learn if GSK2636771 given in combination with~     pembrolizumab can help to control the disease in patients with refractory (has not responded~     to treatment) metastatic melanoma. The safety of this drug combination will also be studied.~      This is an investigational study. Pembrolizumab is FDA approved and commercially available~     and FDA approved for the treatment of several types of cancer, including melanoma. GSK2636771~     is not FDA approved or commercially available. It is currently being used for research~     purposes only. The study doctor can explain how the study drugs are designed to work.~      Up to 41 participants will be enrolled in this study. All will take part at MD Anderson.~   "
33243|NCT03131895|"~     The purpose of this study is to assess the bioavailability of dexlansoprazole from a 30~     milligram (mg) or 60 mg delayed-release capsule manufactured at Takeda GmbH Plant~     Oranienburg, Germany (TOB) relative to that of dexlansoprazole from a 30 mg or 60 mg capsule~     manufactured at Takeda Pharmaceutical Company Ltd. (Osaka, Japan) (TPC).~   "
33244|NCT03131882|"~     Comparing the Efficacy of Ultrasound Guided Hyaluronic Injection with Ultrasound Guided~     Corticosteroid Injection in Treatment of Trigger Finger~   "
33245|NCT03131869|"~     People suffering from swallowing disorders (dysphagia) have a hard time swallowing liquids~     that are too thin (like water or coffee) or too thick, correctly. They can have health~     problems, such as chest infections and malnutrition because when they try to drink, some of~     the liquid goes down the wrong pipe and into the lungs. To help people with dysphagia,~     Swallow Solutions is developing thickened liquids that have added nutrition, taste good, and~     quench thirst, but are still easy and safe to swallow.~   "
33246|NCT03131856|"~     This study aims to investigate the effect of a multi-disciplinary nutritional intervention~     program in geriatric nutritional at risk patients. The study is carried out as randomized~     controlled trial. The intervention consists of an individual dietary plan conducted by a~     clinical dietician before discharge in combination with three follow-up visits after~     discharge (1, 4 and 8 weeks).~   "
33247|NCT03131843|"~     Alcohol is used to disinfect the skin prior to injections in order to prevent infections~     caused by bacteria on the skin being injected within tissue. At present, however, clinical~     trials do not demonstrate a clinical impact of using or not using alcohol swabs on infections~     and infection symptoms calling into question the practice of using it prior to all~     injections. These studies are methodologically flawed, and do not specifically examine~     vaccine injections. The present study is being undertaken to provide some preliminary data~     for the risk of infection and infection symptoms when alcohol swabs are not used to perform~     vaccine injections.~   "
33248|NCT03131830|"~     The primary aim of the study is to investigate personal attitudes regarding mode of delivery~     among both medical health care professionals and non-professionals. The investigators are~     also investigating whether providing detailed information that might influence one's decision~     regarding mode of delivery (such as education on pelvic floor disorders or advantages or~     disadvantages of epidural anaesthesia) will change participants´ opinion how to determine~     their preferred mode of delivery.~   "
33249|NCT03131817|"~     This study will investigate cortical stimulation to treat mood and behavioral symptoms in~     Parkinson's disease patients.~   "
33250|NCT03131804|"~     Hemodialysis (HD) patients have decreased physical functioning, diminished muscle mass and~     altered muscle quality thus the increased mortality rate compared to their age-matched~     population. Risk factors include their sedentary lifestyle and altered nutritional status~     [1]; the sedentary lifestyle or the lack of exercise is known to be a risk factor for~     cardiovascular complications [2] and contributes to worsen protein energy wasting (PEW),~     which is described as the loss of body protein mass and fuel reserves [1]. Therefore the~     health of the HD patients and consequently their quality of life (QOL) is deteriorated.~      Studies have shown that aerobic exercise during HD improves aerobic capacity, blood pressure,~     heart rate, muscular strength, dialysis efficacy and quality of life; however, such studies~     were not done on the United Arab Emirates (UAE) HD patients and there is no protocol for~     implementing exercise in the UAE HD units [3-4]~      Hypothesis: Intradialytic aerobic exercise will result in significantly improved clinical,~     cardio-metabolic and quality of life outcomes and reduced cost of care.~      Primary objective of the study:~      - To investigate whether the intradialytic exercise (IDE) within the routine practice of~     hemodialysis in the UAE will improve adequacy of dialysis.~      Secondary objectives of the study:~        -  To study the effect of clinical and cardio-metabolic outcomes of the HD patients.~        -  Explore whether the trial would improve the cost effectiveness of this patient~          population's health care~        -  Define the nature of the IDE programs (intensity, duration, modality), and feasibility~          of its application in routine setting.~      Importance of this research:~        -  Pioneering research in the Middle East and Gulf Cooperation Council (GCC) countries~          where the effect of intradialytic exercise will be studied for the first time on Arab~          population.~        -  It will contribute in identifying the exact strategies to integrate within the~          hemodialysis unit to improve clinical and cardio-metabolic outcomes, quality of life and~          healthcare cost.~      Usefulness of this research to the UAE~        -  It will improve the health care cost and reduce cost wastage in the UAE (lean~          management).~        -  It will put UAE on the pedestal in front of other countries in integrating innovative~          methods for a better care of hemodialysis patients.~   "
33252|NCT03131778|"~     Patients with resectable liver metastases of colorectal origin will be assigned to~     laparoscopic liver resection or conventional open liver surgery.~      Blood samples will be drawn preoperatively and 24 hours after resection. Determination of~     Interleukin-6 (IL-6) and IL-8 will be done to assess the stress response between open and~     laparoscopic liver resection (Elisa test).~      The Messenger Ribonucleic Acid (mRNA) of inflammation related factors (cyclooxygenase-2~     (COX-2) and Matrix metalloproteinase (MMP-9)), angiogenesis related factor (vascular~     endothelial growth factor (VEGF) and hypoxia induced factor-1 (HIF-1)) in tumor tissue and~     normal liver parenchyma will be detected by real-time real time-Polymerase Chain Reaction~     (RT-PCR).~   "
33253|NCT03131765|"~     Phase 1 study evaluating the safety and tolerability of YS-ON-001 in patients with advanced~     solid tumors who have limited available treatment options, and exploratory evaluation of the~     pharmacological effect and efficacy of YS-ON-001. The study will be conducted in two parts:~     dose escalation and cohort expansion~   "
33254|NCT03131752|"~     Chronic Obstructive Pulmonary Disease (COPD) is characterized by chronic and progressive~     airflow limitations and subjects with COPD also experience exacerbations characterized by the~     worsening of respiratory symptoms. It's necessary medical intervention, changes in regular~     medication, and the use of antibiotics and/or corticosteroids followed or not by~     hospitalization. The exacerbations contribute to worsening of the disease with systemic~     impairment and muscle weakness is a very relevant event. The physical inactivity, especially~     related to bed rest, comprises one of the factors contributing to muscle atrophy and loss of~     muscle strength. Thus, the intervention performed during hospitalization is necessary to~     minimize the consequences which causes impairment in health status subjects. The aim of the~     study is assess the effect of the intervention with elastic bands, in muscle strength,level~     of the physical activity, functional capacity, dyspnea on activities of daily living (ADL)~     and quality of life in COPD exacerbation subjects. Moreover,verify the intervention benefits~     over 01 and 03 months post exacerbation episode. It will be a prospective, randomized,~     longitudinal and interventional study. The investigators will be asses both gender patients~     with exacerbation of COPD in 4 situations: First time (at least 24 and at most 48 hours after~     the beginning of medical therapy); seven days post the first assessment; one and three months~     post exacerbation episode. It will be assess the muscle strength, physical activity level,~     functional capacity, dyspnea on ADL and quality of life. The patients will be randomized in 2~     groups: intervention and control group. The intervention will be performed with elastic bands~     once a day during seven days. The investigators expected that patients of the intervention~     group will present better muscle strength, physical activity level and functional capacity~     than the control group. Furthermore, an improvement in dyspnea and quality of life is~     expected in intervention group when compared as with control group patients. It is~     hypothesized that the benefits of intervention will be maintained over one month.~   "
33255|NCT03131739|"~     The goal of the Alaska Native Resilience Research Study (ANRRS) is to identify~     community-level protective factors that can most effectively reduce co-occurring youth~     suicide and alcohol risk. The following specific aims will help us achieve this overarching~     goal. The research team will: (1): Assess the association of a set of modifiable cultural,~     community and institutional factors (protective community factors) with suicide, suicidal~     behaviors (ideation, attempt), and associated adverse outcomes (accidental death,~     alcohol-misuse requiring healthcare) in 64 rural and remote Alaska Native villages to~     identify community-level factors that are most predictive of youth health outcomes; (2): In a~     stratified random sample of six communities, use quantitative methods to test a multi-level~     model of individual-level youth protective factors as predictors of individual-level youth~     resilience from suicide risk outcomes; and (3): Develop and disseminate a method—Alaska~     Community Resilience Mapping (AK-CRM)—for communities to measure and strategically strengthen~     their protective capabilities to increase youth health and reduce the risk for suicide.~      Methodology:~   "
33256|NCT03131726|"~     In an investigator initiated multicenter trial (Malmö, Odense, Århus) the investigators aim~     at evaluating activity of Graves´ophthalmopathy (GO) and progress to severe GO in patients~     with mild to moderate Graves´ ophthalmopathy treated with diclofenac, simvastatin or no~     treatment.~   "
33257|NCT03131713|"~     The study's goal is to assess impact of preoperative acetaminophen and oral carbohydrate~     drinks on pain and functional status experienced by patients undergoing Mohs micrographic~     surgery for non-melanoma skin cancers. Patients are randomly assigned to receive standard of~     care or preoperative acetaminophen 1000 mg and Gatorade sports drinks 2 packets before~     surgery. Patients are then asked to rate their level of pain, anxiety, thirst, hunger,~     fatigue on a scale of 0-100 on day of surgery before surgery has started, after clearance of~     skin cancer, and at the end of the visit. Patients are contacted by phone 48 hours after~     their surgery to assess their maximum level of post-operative pain (rated from 0-100), usage~     of over the counter or prescribed pain medications, and presence of complications e.g.~     bleeding, infection, dehiscence. Differences in perioperative functional status and pain~     medication usage are compared between patients in control and intervention groups.~   "
33258|NCT03131700|"~     The purpose of this to assess pharmacokinetic bioequivalence between two bevacizumab~     products, RPH-001 (TRPHARM) and EU sourced Avastin® (Roche), after single IV administration~     at 5 mg/kg fixed dose.~   "
33259|NCT03131687|"~     The purpose of this study is to evaluate the efficacy of the study drug LY3298176 in~     participants with type 2 diabetes mellitus.~   "
33260|NCT03131674|"~     This study investigates the effect of cervical physical therapy on tinnitus annoyance in~     patients with somatic tinnitus. This study specifically enrolls patients with co-varying~     tinnitus and neck complaints, with low-pitched tinnitus or patients who's tinnitus can be~     influenced by neck movements or positions.~      These inclusion criteria were chosen, since a prior study showed that these factors were good~     prognostic indicators for a positive treatment effect.~   "
33261|NCT03131661|"~     The purpose of this Italian multicenter study is to collect prospective clinical data in~     participants with first diagnosis or confirmation diagnosis of Spondyloarthritis (SpA),~     according to Assessment of Spondyloarthritis classification (ASAS) criteria, in order to~     describe SpA characteristics and pattern of clinical presentation.~   "
33262|NCT03131648|"~     Primary objective:~      To evaluate the efficacy of tralokinumab compared with placebo in treating moderate to severe~     AD.~      Secondary objectives:~      To evaluate the efficacy of tralokinumab on severity and extent of AD, itch, and health~     related quality of life compared with placebo.~      Maintenance objective:~      To evaluate maintenance of effect with continued tralokinumab dosing up to 52 weeks compared~     to placebo for subjects achieving clinical response at Week 16.~   "
33323|NCT03130855|"~     This split mouth randomized control trial is designed as to compare the effectiveness of the~     buccal infiltration technique with the gold standard inferior alveolar nerve block in~     anesthetizing mandibular second primary molars to undergoing pulpal treatment.~      patient will be videotaped during pulpal treatment of their teeth and an accessing pain will~     be through an objective pain scale (SEM scale), (sound-eye-motor scale).~      the patient will be asked to fill in a subjective Wong Baker pain scale for the pain suffered~     during injecting the local anesthetic agent in both techniques.~   "
33263|NCT03131635|"~     This is a research study examining the effectiveness of a Developmental Reciprocity Treatment~     Program (DRT-P) in treating social deficits in children with Autism Spectrum Disorders (ASD).~     Developmental Reciprocity Treatment is an early intervention that applies~     developmentally-informed teaching methods in naturalistic settings in order to target social~     and communication deficits.~      Researchers have begun to develop strategies to investigate the effectiveness of combining a~     parent training program teaching parents how to implement DRP with in-home,~     therapist-implemented treatment. To determine the effectiveness of the DRT-P, it will be~     compared to a delayed treatment group (DTG) by conducting a randomized controlled 24-week~     trial. This research will allow us to help in the development of therapeutic approaches that~     can meet the increasing service demands for families. We hope that investigating~     interventions that aim to improve core deficits will aid in providing better care for~     children with autism.~   "
33264|NCT03131622|"~     The purpose of this research is to determine if Ibis™, a digital therapeutics solution~     developed by Senscio Systems, reduces the emergency room visits and hospitalizations of~     patients with COPD.~   "
33265|NCT03131609|"~     The purpose of this study is to find the best cleaning and collection methods to obtain a~     'non-contaminated' clean catch mid-stream urine sample to diagnose suspected urinary tract~     infection (UTI).~   "
33266|NCT03131596|"~     In this prospective, randomized, controlled study, the investigators wish to determine the~     efficacy of intrauterine balloon (IUB) dilatation in the prevention of adhesion reformation~     when compared with the conventional management.~   "
33267|NCT03131583|"~     The objective of the study is to assess the pharmacodynamic properties of drug-drug of~     SHR4640, Febuxostat and Colchicine interaction in patients with gout.~   "
33268|NCT03131570|"~     Mild psoriasis not only progresses to moderate-to-severe psoriasis but also precedes systemic~     inflammation that leads to psoriatic arthritis and cardiovascular comorbidities. By curing~     mild psoriasis with a short-term anti- interleukin (IL)-17A treatment, investigators may~     reduce the costs of treating psoriasis and associated medical conditions, including psoriatic~     arthritis, cardiovascular disease, and diabetes.~   "
33269|NCT03131557|"~     A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted~     on hard of participants with a hearing loss to grant quality control prior to product launch.~     The aim of the investigation series is to ensure usability, zero-defect overall performance~     of the new hearing systems as well as maximum benefit for the participant with the devices in~     comparison to previously outstanding Phonak Hearing Systems.~   "
33270|NCT03131544|"~     Over 100,000 BPH procedures are performed annually in the US. The purpose of this study is to~     evaluate the effectiveness of performing MRI guided transrectal laser ablation using a 980 nm~     laser (VisualaseTM by Medtronic, Inc., a Minnesota, U.S.A. company) to treat benign prostatic~     hypertrophy (BPH). The laser system will be used to necrotize urological soft tissue within~     the prostate under MRI guidance. This will be a single center, single arm prospective trial~     with an anticipated enrollment of 10 men. Patients who elect this treatment option and choose~     to be part of the study will be enrolled consecutively.~   "
33271|NCT03131531|"~     This registry has been established to gain a better understanding of the clinical and~     biological characteristics and outcome of patients with lymphoid cancer~   "
33272|NCT03131518|"~     There is a need for a greater understanding of e-bikes and their role in the transportation~     network, and further effects on physical activity (PA) levels and health. Moreover, longtail~     bikes could meet certain practical needs not sufficiently fulfilled by e-bikes or traditional~     bikes, hence increased knowledge regarding their potential and feasibility should be~     obtained. No intervention study has investigated whether providing an e-bike or a longtail~     bike over an extended period in a sample of inactive parents of toddlers influence~     objectively assessed amount of cycling, total PA level, potential mode shifts, and effect on~     cardiorespiratory fitness, body composition and blood pressure.~      Objectives:~      To assess the effect of an intervention where participants have access to an e-bike~     (including a trailer), a longtail bike and a traditional bike (including a trailer) on the~     following parameters:~        1. Objectively assessed amount of biking, total levels of PA, and mode shifts from~          car/motorized modes to bicycle.~        2. Cardiorespiratory fitness, blood pressure, body composition, self-reported health and~          health-related quality of life (HRQoL).~        3. Experiences with bicycling (el/longtail/traditional) and intrinsic motivation for~          bicycling.~        4. How season and weather conditions influence the amount of bicycling~          (el/longtail/traditional).~        5. Potential spill-over effects on the participants' partners~      Study sample:~      A convenience sample consisting of 36 inactive parents of toddlers will be recruited among~     residents in Kristiansand municipality, Southern Norway.~      Measures:~      The following measures will be conducted at baseline and post all intervention arms, i.e. in~     total 4 times:~        1. A web-based questionnaire will assess socio-demographics (at baseline only),~          transportation habits, self-perceived health and HRQoL, and motivation for bicycling for~          transportation. Participants' partners will be requested to fill in the questionnaire at~          baseline and post-intervention to detect potential spill-over effects.~        2. Cycling time and distance will be assessed through usage of a cycle computer, and a~          smart-phone application throughout the entire project period, in total nine months.~           Time spent in moderate-to-vigorous PA (MVPA) will be estimated with the monitor~          SenseWear Armband Mini (SWA) for seven consecutive days at study start and after 9~          months (post-intervention).~        3. Cardiorespiratory fitness will be measured performing treadmill walking/running, and~          dual-energy X-ray absorptiometry (DXA) will be used for assessing body composition. In~          addition, blood pressure, body weight and height (height only at baseline) will be~          measured at baseline and post-intervention.~        4. Participants' experiences with and motivation for usage of the different bicycle types~          will be explored in semi-structured focus group interviews after 3 months, 6 months and~          9 months.~      Weather data (temperature, rainfall, snow, etc.) will also be collected.~      Scientific contribution:~      The present study will add knowledge to relevant and topical areas, i.e. issues related to~     public health and environmental sustainability, among parents of toddlers, representing an~     important target group.There is a call for research on the influence of e-bikes on travel~     behavior and level of MVPA, and whether voluntary cycling with e-bikes could improve health.~     Moreover, to our knowledge no scientific studies have assessed possible effects of using a~     longtail bike, on the selected parameters. If the current study reveals promising results, it~     should be replicated in a larger and more representative sample of parents of toddlers, as~     well as in other important target groups (e.g. older adults). If findings are positive,~     inclusion in national public health policies should be considered.~   "
33273|NCT03131505|"~     The focus of this study is not about what it is like to have a mental disorder, but instead~     the diagnostic experience.~      Some people find diagnoses helpful, but some find them upsetting and harmful. Research is~     therefore needed to improve diagnostic processes. It has been suggested that patient~     experiences and outcomes may be affected by the diagnostic tools used, including diagnostic~     criteria, labels and language. In the NHS, the tool used by doctors to help diagnose people~     is a guidebook called the International Classification of Diseases (ICD). A new version of~     this guide is due to be released in 2018.~      This project will use focus groups to ask people who use mental health services and~     diagnosing doctors in those services what they think about the labels and language in the new~     guide. The investigators can then suggest changes before the guide is published. The~     investigators hope that this research will improve mental health diagnosis. The research will~     take place in Norfolk and Suffolk and span eight months.~   "
33274|NCT03131492|"~     EDMOCS trial pretends to evaluate if C-reactive protein (CRP) and procalcitonin (PCT) can~     predict intestinal anastomotic leaks before early discharge in advanced ovarian cancer~     surgery requiring intestinal resection. These markers have already been positively tested in~     colorectal cancer surgery, but not yet in ovarian surgery.~      Patients undergoing intestinal resection in ovarian cancer surgery will be included.~     C-reactive protein and PCT will be measured pre-operatively, and on the second, fourth and~     sixth postoperative day. Thirty-day readmissions, re-operations and mortality will be~     recorded.~   "
33275|NCT03131479|"~     The purpose of this trial is to evaluate whether the study drug, LIK066, causes glucose~     excretion in urine in patients with varying degrees of decreased kidney function and in~     subjects with normal kidney function. Blood samples will also be collected to measure the~     concentrations of LIK066 and to study the pharmacokinetics of LIK066. Pharmacokinetics is to~     study how LIK066 is absorbed, distributed and eliminated, in other words what the body does~     to the drug. The results of this study may be used to help determine whether LIK066 can be~     used to treat people with reduced kidney function and the proper dosing regimen.~   "
33276|NCT03131466|"~     The study is designed to compare the effectiveness and safety of high-voltage Pulsed~     radiofrequency and nerve block for the treatment of primary Trigeminal Neuralgia patients~     with ineffective conservative treatment and explore better non-surgical treatment methods for~     Trigeminal Neuralgia patients.~   "
33277|NCT03131453|"~     The purpose of this study is to determine the effects of CNP520 on cognition, global clinical~     status, and underlying AD pathology, as well as the safety of CNP520, in people at risk for~     the onset of clinical symptoms of AD based on their age, APOE genotype and elevated amyloid.~   "
33346|NCT03130556|"~     This study is intended to establish the bioequivalence (BE) of single 100 mg doses of~     glasdegib administered under fasted conditions to healthy volunteers as the ICH formulation~     compared to the Phase 2 formulation.~   "
33278|NCT03131440|"~     The overall objective of the proposed research is to pilot test the feasibility and~     acceptability of a set of more scalable technology-supported physical activity promotion~     intervention strategies in breast cancer survivors using tMultiphase Optimization Strategy~     Trial (MOST) methodology. MOST involves highly efficient randomized experimentation to assess~     the effects of individual intervention strategies, and thereby identify which strategies and~     what strategy levels make the important contributions to the overall program's effect on~     physical activity. This information then guides assembly of an optimized physical activity~     program, that achieves target outcomes with least resource consumption and participant~     burden. The resulting intervention will have great potential for scalability because it uses~     technology (smartphones) participants already own and requires no on-site visits.~   "
33279|NCT03131427|"~     CR-GMLD registry started on June 13, 2015 to collect cases of genetic/metabolic liver~     diseases from tertiary or secondary hospitals in mainland China. Demographics, diagnosis,~     laboratory test results, family history and prescriptions were recorded. Patients' whole~     blood and serum were collected for genetic testing and future researches. These patients will~     be followed-up every six to twelve months.~   "
33280|NCT03131414|"~     The IMAGINE Cohort Study will identify and recruit a cohort of 8000 patients with IBS, IBD~     and healthy controls (2000 of each) who will be assessed in terms of their psychological~     status, dietary intake, gut microbiome, metabolomic and inflammatory markers and genotype,~     health-related quality of life, and health care resource use and associated costs. The cohort~     and healthy controls will be followed prospectively for up to 5 years after the completion of~     study enrolment.~   "
33281|NCT03131401|"~     Lymphatic filariasis is a neglected tropical disease earmarked for elimination as a public~     health problem by the year 2020. Since the year 2000, the Global Program for the Elimination~     of LF has together with endemic countries undertaken preventive chemotherapy in endemic~     districts to entire at risk populations. In Ghana, treatment of LF is based on the drugs~     Ivermectin and Albendazole. Remarkable achievements have been made towards the control and~     elimination of LF in Ghana. However, there remain programmatic and implementation challenges~     that need to be addressed in order to ensure that the gains made over the last 15 years are~     sustained. Among these challenges is the persistent transmission of LF in some districts~     despite more than 10 years of MDA.~      Furthermore, LF cases have been identified in communities from eight districts, previously~     considered as non-endemic. The extent of endemicity in these new districts is unknown. In~     order to achieve the 2020 elimination targets, it is crucial to determine the distribution~     and infection prevalence of LF in these districts. Evaluating these districts for LF~     endemicity will help the implementation of appropriate strategies towards achieving the 2020~     target.~      This protocol describes the surveys to be undertaken in Ghana in 3 of these districts. The~     current standard mapping methodologies of LF have the potential to miss LF endemic villages,~     due to the focal nature of LF. As such, in order to enhance the chances to detect endemic~     communities, this survey will use a combination of the WHO EPI cluster survey and current LF~     mapping protocols. 15 communities will be selected in each district, with 100 survey~     participants per community. Survey participants will be screened for LF infection using~     immunological and parasitological methods. Study participants will also be tested for~     onchocerciasis infection using immunological and parasitological methods in districts where~     LF and oncho are co-endemic. The information from this survey will be combined with the data~     on the LF vectors and their infection status in the survey areas and relevant data available~     at the Ghana Health Service to:~        1. determine whether LF intervention strategies are indicated in these three districts,~        2. design, as indicated, appropriate intervention strategies to achieve LF elimination in~          these three districts by 2020~        3. inform, if indicated, co-implementation of control, monitoring and evaluation for LF and~          onchocerciasis in the two onchocerciasis endemic districts~        4. extract lessons learnt for the design and implementation of surveys in the other~          districts currently considered non-endemic but where LF cases have been reported.~      New rapid diagnostic tests have been developed to assess infection Lf and onchocerciasis~     infection prevalence at the time of the decision to stop MDA and for surveillance for new~     infections once MDA has been stopped. These include Rapid Diagnostic Tests (RDT) for~     antibodies against the W. bancrofti antigen WB123 and the O. volvulus antigen Ov16. These~     tests still require large scale field validation. Provided additional funding becomes~     available, this survey will be used to obtain field validation data.~   "
33282|NCT03131388|"~     The Access AMH Assay is an in vitro diagnostic assay intended as an aid for fertility~     assessment. The purpose of the study is to evaluate the clinical performance of the Access~     AMH Assay in the intended use population.~   "
33283|NCT03131375|"~     Dexmedetomidine (DEX) is safe and effective in reducing ED following sevoflurane anesthesia.~     The investigators intend to study the efficacy of DEX in reducing ED in children undergoing~     tonsillectomy with and without adenoidectomy using total intravenous anesthesia (TIVA) with~     propofol .~   "
33284|NCT03131362|"~     This is a multi-centre, prospective, observational study to realize the current situation of~     COPD patients in China. About 5000 COPD patients will be enrolled from 50 participating sites~     around China and followed up for one year. During this study, patients will undergo clinical~     assessments and receive medical care as determined by their treating physician.~   "
33285|NCT03131349|"~     Short stature is defined as height below 3rd centile or less than two standard deviations~     below the median height for that age and sex according to the population standard zinc and~     iron have important role in growth for children~   "
33286|NCT03131336|"~     The purpose of this study is to test the effectiveness and safety of a new peptide-based~     coagulant, PeproStat. The study drug will be applied to patients undergoing liver/soft tissue~     surgery, vascular surgery or spine surgery. The speed of action of the new coagulant, that is~     applied with a gelatin sponge, will be compared to the same sponge but with saline (a~     commonly used standard of care).~   "
33287|NCT03131323|"~     Reactive airway diseases is a common respiratory diseases affecting 1-18% of the population~     in different countries. It carries a significant burden to children, their families, the~     healthcare system and the overall community.The purpose of the study is to delineate the~     prevalence of abnormal nasal finding in wheezy children and evaluate the role of the~     endoscopic examination of the nose in evaluation and management of a wheezy child.Patients~     and methods:The study will be conducted as a prospective case series including all children~     having chest wheezes, aged from two years to eighteen years, attending emergency unit of~     assuit university children hospital~   "
33288|NCT03131310|"~     CPR will be done based on American Heart Association Guidelines for Cardiopulmonary~     Resuscitation (2015) and Emergency Cardiovascular Care of Pediatric and Neonatal Patients.~   "
33289|NCT03131297|"~     Anal fistula treatment is associated with increasing risk of anal incontinence until 40% of~     cases. New and alternative treatments (glue, advancement flap, plug…) decrease this risk, but~     with fistula efficacy treatment in 40 to 60% of cases. Radiofrequency might destroy fistula~     tract without lesion of anal sphincter.~      Objective : Fistula healing rate and anal continence, 6 and 12 months after radiofrequency~     procedure.~      Methods : Clinical and MRI evaluation before, 6 and 12 months after treatment. Patients : 50~     patients with low, high, complex and Crohn disease fistula. An intermediate analysis is~     expected after the first 20 patients, to verify morbidity.~      Evaluations :~        -  Fistula clinical healing 6 and 12 months after procedure~        -  Fistula MRI healing 12 months after procedure~        -  Anal continence before and after procedure~        -  Feasibility og radiofrequency procedure~        -  Morbidity~        -  Success and failure prognostics factors of this procedure~   "
33290|NCT03131284|"~     AIM:~      to reduce the prevalence of overweight and obesity at two years of age in the intervention~     group compared to the control group.~      METHODS:~      Eleven primary paediatricians were randomized to the intervention group and intensively~     trained about the trial intervention. Each of them was asked to consecutively recruit the~     parents of at least 30 newborns taken in charge within the first six months of the study, and~     to provide them with standardized oral and written information on protective practices during~     all the well visits scheduled in the first two years of the child's life.~      Another eleven primary paediatricians were randomized to the control group, and were asked to~     consecutively recruit the parents of at least 30 newborns taken in charge within the first~     six months of the study and to provide them with usual care and follow-up. When all recruited~     children have completed the second year of life, the two groups of toddlers will be compared~     as regards the prevalence of overweight/obesity, defined by WHO cut-offs of the weight/length~     ratio.~   "
33383|NCT03130075|"~     Increasing the number of Turkish version of the questionnaire evaluating hand use, adding the~     scales that evaluate the selective movements of the upper limb to the evaluations will~     increase the variety of evaluation methods.~      The purpose of this study is to evaluate the validity and reliability of the Turkish version~     of the Caregiver Functional Use Survey (CFUS)~   "
46596|NCT02956967|"~     Non-interventional, non-comparative, national, multi-site, single-arm prospective~     observational study to investigate home administration of Nivestim in the primary prophylaxis~     of chemotherapy-Induced febrile neutropenia~   "
33291|NCT03131271|"~     Background: Removal of femoral arterial catheter causes pain, and current interventions used~     for reducing this pain are not sufficiently effective.~      Aims: The aim of this study is to determine the pain reduction effectiveness of ice bag~     applications to the femoral region in patients undergoing percutaneous coronary intervention.~      Design: A randomized controlled trial with repeated measures and two-group design.~      Setting: This study was conducted at the Yilmaz-Mehmet Oztaskın Heart and Vascular Hospital~     located in Kayseri, Turkey.~      Participants: The study was completed with a total of 104 patients who met the inclusion~     criteria: 52 each in the experimental group and the control group.~      Methods: The data were collected by the researcher using Patient Identification Form,~     Numerical Rating Scale (NRS), and Vital Signs Monitoring Form. An ice bag was applied to~     patients in the experimental group for 20 minutes before removal of the catheter. The nurse~     performing the application was also responsible for the catheter removal, immediately after~     the ice bag was removed. Standard procedures of the clinic were applied to the control group.~     According to the relevant standard procedures, the catheter was removed by the nurse without~     making any other application to femoral region, and pressure was applied on catheter site.~     The pain experienced by the patients was evaluated before, and during removal and again while~     the nurse applied pressure on the catheter site after removal. The NRS scores were identified~     as NRS1, NRS2 and NRS3 for the three assessment, respectively.~   "
33292|NCT03131258|"~     Kidney transplant is the most effective choice of treatment for patients with end-stage~     kidney failure in terms of quality of life and longevity. Today, 20-25% of kidney~     transplantations are implemented with living donors.~      Donor nephrectomy is an operations which has the end goal of a living donor donating one of~     his kidneys to a patient with end-stage kidney failure (1).~      Pre-operative anxiety is a condition which is characterized by a random illness, being~     hospitalised, anesthesia, surgery, or uneasiness or anxiety stemming from not knowing what is~     to be experienced. Educating and informing in the pre-operative period is the first step in~     mentally preparing the patient for the operation. In some studies, it has been pointed out~     that patients who were thoroughly informed in the pre-operative period have lower anxiety~     levels both in the pre-operative and post-operative periods with also less levels of pain and~     increased recovery rates in the latter (2).~      Anesthetic recovery starts at the end of the surgical process and ends with the anesthetized~     patient completely regaining a wide-awake, responsive state, defensive reflex, and muscle~     strength.~      Post-operative pain is acute pain which starts with surgical trauma and ends with tissue~     healing (3). Providing optimal post-operative analgesia plays an important role in the~     prevention of post-operative complications (1,4,5).~      There are studies which examine the link between pre-operative anxiety and post-operative~     pain (59,74,74,77,78). Patients who will undergo a donor nephrectomy constitute a specific~     group of patients both because they are not operated due to a health problem that they have~     and because the operation results with them losing an organ. There are no prospective studies~     about the effects of pre-operative anxiety on anesthetic recovery and post-operative pain in~     individuals who have undergone donor nephrectomy in literature. Because of this, we have~     aimed to research prospectively the effects of pre-operative anxiety on anesthetic recovery~     and post-operative pain in patients that were to undergo donor nephrectomy surgery.~   "
33293|NCT03131245|"~     Changes of optic nerve sheath diameter after position changes~   "
33294|NCT03131232|"~     In summary, the registry should provide novel insight into potential mechanisms of~     cardiovascular risk reduction in patients treated with Empagliflozin with an indication of~     intensified glucose lowering therapy based on their HbA1c level.~   "
33295|NCT03131219|"~     The purpose of the study is to assess the efficacy of ALXN1210 to control disease activity in~     children and adolescents with aHUS who have not previously used a complement inhibitor.~   "
33296|NCT03131206|"~     This research trial is studying a drug called alectinib as a possible treatment for non-small~     cell lung cancer (NSCLC) with specific genetic alterations known as ALK or RET~     rearrangements, and thyroid cancer with RET rearrangements.~   "
33297|NCT03131193|"~     The evidence on how primary care provider supply and skill relates to patient outcomes is~     limited and inconclusive. The issue of skill is a particularly important one in low-income~     countries where the shortage of skilled medical professionals has led to greater use of the~     task-shifting model in which medical tasks are redistributed from highly skilled health~     workers to mid-level providers who receive less training. In this large-scale~     cluster-randomized trial, the investigators randomly select primary health care facilities to~     receive a highly skilled provider (a doctor), a mid-level health provider, or no additional~     providers (the control group). The investigators study the effect of this intervention on~     patient outcomes. Embedded within this trial is another experimental intervention in which~     pregnant women residing in communities served by the primary health care facilities are~     assigned to receive a cash transfer conditional on using antenatal, delivery and postnatal~     care. The investigators study the effect of the cash transfer on health care utilization and~     on maternal and infant outcomes.~   "
33298|NCT03131180|"~     Engaging patients and families to take an active role in their healthcare leads to improved~     outcomes. Providing physicians and families with near real-time data on outcomes in children~     with similar medical conditions can allow families to form realistic expectations and take an~     active role in their child's health. It also provides physicians with near real-time feedback~     on patient-reported outcome measures to guide both conversations and recommendations for~     therapy at the point-of-care.~      A rapid learning healthcare system (RLHS) is a system that merges clinical research and~     clinical care. It is designed to collect data during routine patient care and then utilize~     the data to rapidly generate evidence to improve patient care, provide information to~     patients and families, and track quality measures.~      The investigators created a RLHS that integrates pre-specified data elements and validated~     surveys within the clinical workflow in order to operationalize automated research data~     collection and integrate predictive analytics into the electronic health record (EHR).~     Patients, caregivers, and physicians can access data in order to make informed, shared~     decisions about care and align expectations about outcomes.~   "
33299|NCT03131167|"~     Safety and tolerability of three different concentrations (0.1%, 03%, 0.6%) of the~     investigational SHP639 eye drops will be evaluated in subjects with high eye pressure or~     primary open-angle glaucoma. There will be up to 12 cohorts in total, 1 cohort for each dose~     level and different dosing regimen. Each cohort will consist of 7 subjects for a total of 84~     subjects in the study. Eligible subjects will be randomly allocated in a 5:2 ratio to receive~     either SHP 639 or placebo eye drops, respectively. A sufficient number of subjects will be~     screened and enrolled to ensure that at least 6 of 7 subjects complete each treatment in~     their assigned cohort. The study will be blinded, i.e. masked by procedures that prevent~     study subjects, caregivers, investigators and outcome assessors from knowing which~     intervention was received. The study will be conducted in the several centers in the US.~   "
33300|NCT03131154|"~     A Phase 3, randomized, double-masked, vehicle-controlled trial to evaluate the safety and~     efficacy of ADX-102 ophthalmic solution in Subjects with non-infectious anterior-uveitis.~   "
33303|NCT03131115|"~     Lateral nasal wall insufficiency is a source of nasal obstruction which plagues many people~     as the sidewall of the nose collapses due to negative pressure and structural weaknesses of~     the nose. Bone anchored suture suspension is used by many surgeons to treat it, and involves~     anchoring the nasal sidewall to the bony rim below the eye. Lateral crura strut graft is~     another well described and universally used technique involves strengthening lateral crus of~     lower lateral cartilage of the nose with piece of cartilage. This study aims to compare the~     two well known and universally used treatments to each other. Based on expert opinions these~     procedures are both safe and efficient but given lack of randomized clinical trials comparing~     these 2 techniques, it is difficult to extrapolate which procedure is superior.~   "
33304|NCT03131102|"~     In surgical patients early risk prediction of postoperative complications and organ~     dysfunctions is still an important clinical challenge whereas appropriate risk predictors are~     still missing. In this regard, fatigue is a complex phenomenon, is affected by many factors~     and has been shown to be associated with delayed return to normal activity after surgery. The~     investigators hypothesize that early tiredness (acute fatigue) assessed shortly after surgery~     is associated to postoperative complications and organ dysfunctions and might be used for~     risk stratification. Therefore, in this prospective, observational study the investigators~     introduce and evaluate a newly developed score to assess early fatigue during the~     perioperative period (Acute Fatigue Score, AFS).~      The AFS and the Identity-Consequence Fatigue Scala will be used to assess early fatigue and~     perioperative time courses and inter-rater-variability will be evaluated. The rating of these~     two fatigue scores will be evaluated regarding the association with hemodynamic, immunologic,~     endothelial, metabolic, gastrointestinal measures as well as organ dysfunction and~     complications after surgery.~      Furthermore, hemodynamic, immunologic, endothelial, metabolic and gastrointestinal measures~     are investigated with respect to the intraoperative course and postoperative organ~     dysfunction and complications. In a subgroup of patients, patients will undergo specialized~     metabolic measures to investigate mitochondrial dysfunction during the perioperative period.~   "
33305|NCT03131089|"~     This study is prospective cohort study to investigate and identify comprehensively the~     clinicopathological features and long-term outcome of young breast cancer (YBC).~      We have enrolled Breast cancer patients under 40 year-old and collected their baseline~     characteristics including tumor character, familiar history and other background information.~     Moreover, we have collected breast cancer tissue/blood sample for analyzing genetic~     characteristics, if patient agree to genetic analysis.~   "
33306|NCT03131076|"~     Over 500 patients were participating in the IPMN follow up between september 2014 and august~     2016 at the Helsinki University Hospital. In this study we are going to determine the effects~     of the IPMN surveillance on the quality of life and anxiety levels of the patients.~   "
33307|NCT03131063|"~     The PHARMECMO study is a pilot, prospective, pharmacokinetic study, conducted in a cardiac~     surgery intensive care unit of 18 beds. Optimization of antibiotic therapy for extracorporeal~     membrane oxygenation (ECMO) patients remains a pharmacological challenge. Clinical studies~     suggest that individualized dosing strategies and therapeutic drug monitoring could~     facilitate the achievement of adequate antibiotic concentration. The objective of this pilot~     study was to observe the pharmacokinetic characteristics of commonly used antibiotics in~     intensive care for patients treated with extracorporeal membrane oxygenation.~   "
33308|NCT03131050|"~     Despite the availability of a wide range of antidepressant drugs, clinical trials indicate~     that 30% to 40% of patients with major depression fail to respond to first-line~     antidepressant treatment, despite adequate dosage, duration, and compliance. Moreover, in~     those patients who do experience symptomatic relief following conventional anti-depressant~     treatment, clinical improvement is not evident for 3-4 weeks. Thus, there is a clear need to~     develop novel and improved therapeutics for unipolar depression.~      A previous study showed that the intravenous administration of scopolamine produces~     antidepressant effects. This study is designed to determine if scopolamine combine with~     Escitalopram produce antidepressant effects at an early stage.~   "
33309|NCT03131037|"~     This is a phase I study of Gene Mediated Cytotoxic Immunotherapy (GMCI) in patients with~     non-small cell lung cancer (NSCLC). The primary clinical end-point of the study is to~     evaluate the safety of GMCI when combined with standard surgery for NSCLC. The primary~     scientific objective is to determine the immunologic changes induced by GMCI.~   "
33310|NCT03131024|"~     Doxorubicin and epirubicin are part of the class of chemotherapy agents called anthracyclines~     that are commonly used to treat breast cancer. Although these treatments work well against~     the tumor, they are known to cause damage to the heart muscle, resulting in diminished heart~     function that can be permanent, and may also damage the blood vessels and skeletal muscles.~     The purpose of this study is to determine whether short-term application of these~     interventions with specific timing relative to the receipt of each treatment can prevent the~     negative effects of anthracycline treatment on the heart, aorta (largest artery leaving the~     heart), and skeletal muscle, improve quality of life and reduce tumor size. Fifty-six early~     stage breast cancer patients who will receive anthracycline treatment will be randomly~     assigned to 1 of 3 groups who will: 1) perform a single 30-minute aerobic exercise session 24~     hours prior to each treatment; 2) eat a diet consisting of 35% less calories for 48 hours~     prior to each treatment; or 3) receive usual cancer care. Magnetic resonance imaging (MRI)~     will be used to precisely measure the function of the heart, aorta, and the lower leg~     skeletal muscle at rest, and again during exercise to allow detection of more subtle signs of~     damage. We will also measure exercise capacity (i.e. aerobic fitness), microscopic damage to~     the heart muscle cells, a marker released into the blood in response to anthracycline-related~     heart damage, tumor size in patients receiving chemotherapy before surgery, quality of life~     and fatigue. These measures will be performed before treatment, at the end of treatment and 1~     year later.~   "
33384|NCT03130062|"~     To analyze the effectiveness of 16-week resistance exercise in daily motor behavior and~     functional fitness in women with Primary Sjögren's Syndrome. The present study presents as~     hypothesis that a supervised resistance exercise program is effective and safe in improving~     the functional fitness and quality of life of patients with Primary Sjögren's Syndrome,~     making them more physically active, contributing positively to the capacity to perform daily~     life activities as household and / or professional tasks.~   "
33311|NCT03131011|"~     A phase II prospective, randomized control trial assessing the impact of invisible ink~     ultra-violet (UV) tattoo ink versus conventional black tattoo ink for radiotherapy treatment~     localization on the quality of life of breast cancer patients undergoing adjuvant~     radiotherapy. The effect of tattoo type on quality of life will be measured objectively using~     the externally validated body-image satisfaction (BIS) scale as the primary outcome of~     interest, with secondary endpoints including: accuracy/reproducibility of radiotherapy setup~     using the invisible ink tattoos, resource impact requirements, and clinical feasibility. A~     sample size of 60 patients is planned (30 per study arm) with an anticipated accrual period~     of 18 months.~   "
33312|NCT03130998|"~     Compared to smokers who are not depressed, smokers with depression who try to quit smoking~     are 10% less likely to succeed when given standard treatment. A simple program with a~     detailed handout on relaxation exercises and a journal to record mood and urges to smoke when~     trying to quit has been shown to increase quit success in depressed smokers by 12 to 20%.~     However, it remains unclear how to best implement this knowledge into primary care settings.~      Through this study, the investigators will seek to answer the following questions:~        -  Does a knowledge broker communicating via generic email reminders engage clinicians to~          provide patients resources for mood management more or less frequently than via~          interactive technology (eKB)?~        -  Which Knowledge Translation (KT) strategy used to change clinicians' behavior (emails~          vs. eKB) has the greatest effect on smoking quit rates in depressed smokers?~        -  What is the incremental cost effectiveness of the two KT strategies?~   "
33313|NCT03130985|"~     Patients undergoing coronary artery bypass grafting (CABG), aortic (valve) or mitral valve~     surgery are at risk of developing postoperative and new-onset atrial fibrillation (AF), but~     adequate risk prediction is currently impossible. This study aims to discover tissue and~     circulating microRNAs and protein biomarkers that may help to unravel the pathophysiological~     processes underlying AF and are potential tools for risk stratification and prognosis or may~     become future targets of therapy.~      This study will be a single-center cohort study of 150 patients undergoing cardiac surgery,~     which will constitute the beginning of the follow-up period. Left atrial appendages, whole~     blood and epicardial mappings will be collected. Patients will be followed for 2 years with~     regular holter investigations to detect postoperative and new-onset AF.~   "
33314|NCT03130972|"~     This study aims to identify the etiology of children with motor developmental delay, in~     association with the results of magnetic resonance imaging and genetic analysis.~   "
33315|NCT03130959|"~     The purpose of this study is to determine the safety and effectiveness of nivolumab alone and~     in combination with ipilimumab in pediatric patients with high grade primary central nervous~     system (CNS) malignancies~   "
33316|NCT03130946|"~     Axillary lymph node status is a vital prognostic factor in breast cancer patients and~     provides crucial information for making treatment decisions. Ultrasound test with subsequent~     fine needle aspiration (FNA) biopsy in nodes with suspicious features remains the standard of~     axillary lymph node workup. Insufficient sampling and limited diagnostic accuracy of~     cytological test compromise the outcome the preoperative lymph node staging strategy~     especially in patients with intermediate suspicious nodes. This prospective study is to~     compare the performance of a crpo-assisted core biopsy with FNA.~   "
33317|NCT03130933|"~     Objectives: The objective of the study was to evaluate the effectiveness of a prophylactic~     single preoperative dose of amoxicillin in decreasing complications after lower third molar~     surgery.~      Materials and methods: The sample consisted of 400 patients randomly divided in two groups~     consisting of 200 patients per each group. The patients underwent third molar surgery at the~     Department of Oral Surgery, Clinical Hospital Dubrava, Croatia, in the period between April~     2010. and November 2016. Unlike the patients from the second group, the first group of~     patients had never been diagnosed inflammation prior the surgical procedure. The main tested~     groups were further divided in two subgroups (control and tested): the tested subgroup (100~     patients) received a prophylactic single dose of 2 g amoxicillin an hour prior the procedure,~     while the second control subgroup (100 patients) received a placebo. Complications, including~     swelling, alveolar osteitis (AO), infection at the surgical site (SSI), limited mouth~     opening, pain, bleeding, and increased body temperature, were evaluated postoperatively.~     Evaluation was done on the first postoperative day and 7 days after surgery.~   "
33318|NCT03130920|"~     The aim of this study is to evaluate hepatoprotective effect from ischemia-reperfusion injury~     of remote ischemic preconditioning of the liver against local ischemic preconditioning of the~     liver during human liver resections.~   "
33319|NCT03130907|"~     It is well established that uncomplicated distal ureteroscopy can be safely performed without~     leaving a ureteral stent. However, many urologists continue to leave ureteral stents~     following uncomplicated ureteroscopy, regardless of stone location, due to concerns for~     post-operative complications, patient symptoms and to reduce unplanned medical visits. There~     is a paucity of data regarding the utility of stent placement for proximal ureteral or renal~     stones following ureteroscopy. We have designed a prospective, randomized controlled trial to~     evaluate the role of ureteral stent placement following ureteroscopy and pyeloscopy in~     proximal and renal stones.~   "
33320|NCT03130894|"~     Background: The association of trimethylamine-N-oxide (TMAO), a microbiota dependent~     metabolite from dietary choline and carnitine, with type 2 diabetes was inconsistent.~      Objective: The investigators planned to investigate the association between plasma TMAO and~     newly diagnosed type 2 diabetes as well as whether the association could be modified by the~     TMAO-generating enzyme flavin monooxygenase 3 (FMO3) polymorphisms.~      Design: This is an age- and sex-matched case-control study of 2694 participants: 1346 newly~     diagnosed cases of type 2 diabetes and 1348 controls. The patients of newly diagnosed type 2~     diabetes were consecutively recruited from those attending for the first time the outpatient~     clinics of Department of Endocrinology, Tongji Medical College Hospital, Wuhan, China, from~     2012 January to December 2014. Concomitantly, the investigators recruited healthy individuals~     who were frequency-matched by age (±5 years) and sex to patients from an unselected~     population undergoing a routine health check-up in the same hospital. The inclusion criteria~     for controls and newly diagnosed type 2 diabetes were: age ≥ 30 years, body mass index (BMI)~     < 40 kg/m2, no history of a diagnosis of diabetes and no history of receiving pharmacological~     treatment for hyperlipidaemia or hypertension. Patients with clinically significant~     neurological, endocrinological or other systemic diseases, as well as acute illness or~     chronic inflammatory or infective diseases, were excluded from the study. All the~     participants enrolled were of Chinese Han ethnicity. All the participants gave informed~     written consent to the study and did not take any medication known to affect glucose~     tolerance or insulin secretion before participation. The study was approved by the ethics~     committee of the Tongji Medical College. Concentrations of plasma TMAO were measured, and~     FMO3 E158K polymorphism (rs2266782) were genotyped.~   "
33324|NCT03130842|"~     Diagnostic upper GI endoscopy can be uncomfortable and stressful for many patients. Various~     methods are available for sedation during this procedure. Because of some side effects~     related to intravenous administration of sedatives, oral administration of these drugs is~     under attention. Alprazolam is a benzodiazepine which is used mainly in treatment of anxiety.~     Intravenous midazolam is being used by some centers for sedation during endoscopy, but the~     oral form can also be used with probably same efficacy. Hence, investigators compare the~     efficacy/safety of oral midazolam and sublingual alprazolam as for sedation during this~     procedure. Investigators hypothesize that sublingual alprazolam is as effective as oral~     midazolam in reducing anxiety and pain/discomfort related to the procedure.~   "
33325|NCT03130829|"~     Primary Objectives:~      To evaluate the Quality of Life (QoL) score of adding oral Oligo Fucoidan to platinum-based~     chemotherapy in comparison with placebo in subjects with Non-Small Cell Lung Cancer (NSCLC).~      Secondary Objectives:~      To assess the progression-free survival (PFS) and objective response rate (ORR) of adding~     oral Oligo Fucoidan to platinum-based chemotherapy in comparison with placebo in subjects~     with NSCLC.~   "
33326|NCT03130816|"~     In our prior study on the therapeutic mechanism of UCB, changes in cytokine levels were~     observed but the results are inconclusive and further studies on animal models and changes of~     protein expression before and after UCB therapy in the clinical settings are required.~      The changes in protein expression will be assessed by multiplex RT-PCR mRNA assay. Clinical~     efficacy of UCB therapy will be evaluated with various functional assessment tools. Factors~     regarding UCB therapy (number of transplanted cells, HLA matching status, serum level of~     immunosuppressant, etc.) and patient factors (age, functional status, etc.) will be analyzed~     for correlation with protein expression after UCB therapy. Several target proteins for~     analysis are available. Pentraxin and toll-like receptor (TLR) 4 are receptors modulating~     intrinsic immune reaction and was shown to have a significant correlation with clinical~     efficacy of stem cell therapy. Ubiquitine is a regulatory protein that combines with the~     target protein and affects its degradation, interaction, localization and activation. The~     ubiquitine system controls total protein quantity for homeostasis and can be found in all~     tissues. Deubiquitination (DUB) enzyme down-regulates this ubiquitine and is known to~     modulate all cellular changes~   "
33327|NCT03130803|"~     Sleep and wakefulness disorders impact 50 to 70 million Americans and insufficient sleep is~     epidemic with over 50% of Americans reporting less than 7 hours of sleep per night. Health~     problems associated with insufficient sleep include inflammation, depression and anxiety,~     diabetes, stress, drug abuse, poor quality of life, obesity, and fatigue related accidents on~     the job/while driving. While the contribution of sleep to overall health, well-being, and~     public safety is recognized, no established clinical biomarkers of sleep deficiency exist.~     Such biomarkers would have utility as road-side biomarkers of sleepiness (e.g., drowsy~     driving), monitoring on the job fatigue/fitness for duty (e.g., transportation, military ops~     health care), monitoring sleep health, as well as for clinical diagnostics and measures of~     clinical treatment outcomes. Thus, investigators designed a controlled laboratory~     insufficient sleep protocol utilizing metabolomics to identify biomarkers of insufficient~     sleep. Investigators propose to identify changes in metabolites that consistently occur~     during insufficient sleep. As an exploratory outcome investigators will examine associated~     changes in metabolites and cognitive performance during insufficient sleep.~   "
33328|NCT03130790|"~     This protocol for Varlitinib is developed for the treatment of Gastric Cancer. Varlitinib~     (also known as ASLAN001) is a small-molecule, adenosine triphosphate competitive inhibitor of~     the tyrosine kinases - epidermal growth factor receptor (EGFR), human epidermal growth factor~     receptor (HER)2, and HER4. Varlitinib may be beneficial to subjects with cancer by~     simultaneous inhibition of these receptors. The purpose of this study is to determine the~     safety and efficacy of Varlitinib in combination with mFOLFOX6 for the treatment of Gastric~     Cancer. Treatment groups are Varlitinib+mFOLFOX6 and Placebo+mFOLFOX6.~   "
33329|NCT03130777|"~     To demonstrate the safety and functionality of the Edwards Alterra Adaptive Prestent in~     conjunction with the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System in patients with~     a dysfunctional right ventricular outflow tract/pulmonary valve (RVOT/PV) who are indicated~     for treatment of pulmonary regurgitation (PR).~   "
33330|NCT03130764|"~     Despite aggressive surgery and chemotherapy, the risk of lung cancer recurrence remains high~     in most patients. This study aims to determine if a novel immune therapy consisting of two~     drugs is feasible and potentially increases the chance of cure in lung cancer patients after~     surgery and standard chemotherapy. The immune-based therapy being given in this study~     consists of two medications named durvalumab and tremelimumab.~   "
33331|NCT03130751|"~     This study is the user testing phase of a mobile application intervention which will be~     designed to promote positive coping skills, illness resilience, and social support, and to~     serve as a complement to patient-physician interactions in adolescents and young adults (AYA)~     with sarcoma. User testing will be conducted with a prototype of the app. Participants will~     be AYA ages 13-25 with sarcoma (N=16). Study participation involves the AYAs downloading and~     using the app for 30 days. During the 30 days, participants will interact with the app by~     inputting their current mood, receiving supportive feedback from the app, reading messages,~     and doing brief activities (such as relaxation activities, etc.). Participants will also~     participate in an online focus group focused around the user experience. Before and after the~     30 days of user testing, participants will complete a few brief questionnaires about their~     behavior, how their symptoms affect their life, and how they receive support from others.~     These questions will take around 20 minutes to complete at each administration.~   "
33332|NCT03130738|"~     The purpose of the study is to evaluate the efficacy and safety of active treatment~     (miconazole oil) for 7 versus 14 days, and to compare 14 days of active treatment (miconazole~     oil) to inactive treatment (placebo) over a 14-day treatment duration, in subjects with~     fungal infection (otomycosis) of the external ear.~   "
33385|NCT03130049|"~     The study aims to investigate the effect of the popliteal plexus block (PPB) on postoperative~     pain in patients undergoing anterior cruciate ligament (ACL) reconstruction.~   "
33386|NCT03130036|"~     This is a single center imaging study that will recruit 30 participants who are enrolled in~     the Brain Energy And Memory study (BEAM) protocol. This cohort of patients, aged 50-85, will~     receive a maximum of 3 [11C]Acetoacetate (AcAc)/[18F]Fluorodeoxyglucose (FDG) PET scans over~     18 weeks as part of this supplemental trial.~   "
33333|NCT03130725|"~     Dental caries, is one of the major public health problem in Pakistan. Dental sealants are~     known cost effective preventive measure of dental caries as compared to other preventive~     measures. Resin based sealants, is a proven treatment of pits and fissure sealants but~     retention is still problem. This trial will assess the use of amalgam sealants as an~     effective and retentive preventive measure in preventing dental caries in children as~     compared to the standard resin-based sealants. The findings of this randomized controlled~     trial will be used to raise awareness among the health care professionals, help them to~     choose amalgam sealants as an effective caries prevention method thereby reducing the burden~     of cost as amalgam is cheaper material compared to resin-based sealants.~      The research question Is there any difference in the six months retention of bonded amalgam~     sealants compared to resin-based sealants among 12 to 16 years old children in Karachi~   "
33334|NCT03130712|"~     In this study, CART cells are targeted to GPC3 by intratumor injected that we hope by this~     means could improve the local CAR-T cell numbers, meanwhile reduce the potential side~     effects.~   "
33335|NCT03130699|"~     This study will compare Dulce Digital (i.e., the investigators' proven-effective combination~     of one-size-fits-all educational text messages and nurse monitoring of patient-transmitted~     blood glucose values) and Dulce Digital-Me (DD-Me), an adaptive/dynamic mHealth (mobile~     health) intervention that is tailored to individuals' needs and behavioral progress, in~     improving diabetes clinical control, adherence, and patient-provider communication in~     Hispanics - an at-risk, understudied population that experiences disparities in diabetes~     prevalence and outcomes. These striking disparities in the growing and aging US Hispanic~     population have taxed the US healthcare system, while significantly reducing quantity and~     quality of life for millions of individuals. By offering an innovative, scalable, and~     sustainable approach that seamlessly integrates several mHealth technologies into existing~     primary care team processes to improve the health of Hispanics (and eventually, other~     at-risk, underserved groups), DD-Me has strong potential to significantly impact public~     health.~   "
33336|NCT03130686|"~     The purpose of this study is to measure the blood pressure level of the patients, using a~     cuff ranged 17 - 50 cm.~   "
33337|NCT03130673|"~     An observational study using the information records at the Hospital Regional Rafael~     Hernandez, in Chiriqui, Panama, that will help to analyze the epidemiology and early~     treatments results of hip fracture patients treated in this institution.~   "
33338|NCT03130660|"~     We plan to compare single person short axis view with two person long axis view~   "
33339|NCT03130647|"~     Transcranial focused ultrasound (tFUS) is a form of neuromodulation that uses a single~     element transducer to produce highly focused low-intensity acoustic energy that can be used~     to affect cortical excitability in humans.~   "
33340|NCT03130634|"~     Primary objectives: Use both listed and relatively safe drug, Silymarin,s to improve the~     intestinal side effect of the patients undergoing FOLFIRI chemotherapy.~   "
33341|NCT03130621|"~     Through exploring the specific genetic mutations in the upper gastrointestinal tract tumors~     with a family history and specific clinical pathological types，we establish a complete family~     and follow-up system，in order to improve the screening criteria of Chinese hereditary upper~     gastrointestinal tumors and carry on primary prevention of disease.~   "
33342|NCT03130608|"~     Individuals with chronic liver disease develop significant muscle wasting that remains~     post-liver transplant. The transplant surgery additionally challenges respiratory mechanics.~     Respiratory muscle strength has been measured to be impaired in individuals post liver~     transplant. This study proposes an 8 week intervention designed to increase respiratory~     muscle strength and pulmonary function that we hypothesize will correlate to improved~     functional performance and quality of life post-liver transplant.~      Pre-test post-test design, that will randomize subjects into an experimental group that will~     receive the inspiratory muscle strengthening exercise in addition to usual post-liver~     transplant care and a control group that will only receive the usual post-transplant care.~      Up to 50 subjects will be recruited from the Post-Liver Transplant Outpatient Clinic at the~     Miami Transplant Institute.~      The subjects will have repeated measurements of respiratory muscle strength, pulmonary~     function, functional mobility performance, and quality of life at baseline, 4 weeks, and 8~     weeks.~   "
33343|NCT03130595|"~     WestPORTS will recruit a randomly selected population consisting of 25% of all individuals~     with Parkinson's disease (ICD G209) that have visited any of the seven major outpatient~     neurology or geriatrics clinics in West Sweden (population 1.7M) during a predefined 12 month~     period between Sept 2016 and April 2018.~      Baseline clinical and demographic data will be collected along with a 6 x 24h accelerometry~     recording using the Parkinson Kinetigraph (Global Kinetics). Repeated data collections will~     be made with regular intervals of up to 2 years as long as subjects are alive and willing.~   "
33344|NCT03130582|"~     patients with refractory /relapsed lymphoma received high-dose etoposide for hematopoietic~     stem cell (HSC) mobilization.All patients received high-dose etoposide 20-25 mg/kg/d~     intravenously for two consecutive days followed by rhG-CSF10ug/kg/day subcutaneously at 48~     hours after chemotherapy; rhG-CSF was continued until the end of harvesting for HSCs/HPCs.~     Peripheral blood counts were performed daily for all patients following the initiating of~     rhG-CSF. Leukapheresis was performed when peripheral blood white blood count exceeded 4×109/L~     with blood cell The harvested cells reached at least 2*108/kg for mononuclear cells and/or~     2*106/kg for CD34+ cells with once to twice leukapheresis. The final product was kept frozen~     in liquid nitrogen.Auto-PBSCT~   "
33345|NCT03130569|"~     This study will have two phases, with an added usability test after Phase I and before Phase~     2. Phase 1: Cognitive Interviews of materials in Spanish. Phase 2: Personalized Genomic~     Testing for Skin Cancer (PGT-SC). The overarching goal of this study is to learn more about~     how to maximize the availability, comprehension and appropriate uptake of personalized~     genomics among different populations in New Mexico. Primary Care patients will be recruited~     in their primary health clinic to complete surveys about their understanding and beliefs of~     skin cancer and behaviors that might help prevent skin cancer. 6 out of every 7 patients will~     then be asked to go to a website to learn more about skin cancer risk. Once participants have~     completed the education modules on this site, participants will be given the option to~     request and complete a skin cancer genetic testing kit. All participants will be contacted~     again after three months to complete a follow-up set of surveys about skin cancer.~   "
33347|NCT03130543|"~     Infants often present to the hospital with episodes of coughing, choking, gagging, change in~     muscle tone, and/or change in skin color, known as brief resolved unexplained event. Many~     studies have tried to address why infants have these symptoms and if there is a way to~     prevent them from happening again. Currently, there is no clear agreement on the most common~     cause of these symptoms or how to prevent them. Some studies have suggested that~     gastroesophageal reflux can cause these symptoms. The investigators are conducting a study of~     infants who are admitted to Boston Children's Hospital with episodes of coughing, choking,~     gagging, change in muscle tone, and/or change in skin color, symptoms that could be reflux.~     The investigators want to determine if these symptoms can be prevented by changing the way~     infants are fed, either by giving them a formula to treat reflux or by thickening their feeds~     to treat reflux. The goal of the study is to determine if different types of feeding~     interventions prevent infants from coming back to the hospital.~   "
33348|NCT03130530|"~     The ALF-X (Advanced Laparoscopy through Force reflection) Robotic Surgery System is a medical~     device that is available for distribution in the EU (European Union) under CE Mark for use in~     general surgery, thoracic surgery, gynecological surgery and urological surgery. The main~     research question is to assess, from a retrospective poit of view, the safety and feasibility~     of this new robotic platform in the colorectal surgery.~   "
33349|NCT03130517|"~     hemolytic disease of newborn is an important cause of hyperbilirubinemia with significant~     morbidity and mortality in neonatal period. intravenous immunoglobulin has widely used in~     management of hemolytic disease of new born~   "
33350|NCT03130504|"~     Antepartum hemorrhage is defined as bleeding from or within the female genital tract,~     occurring from 24+0 weeks of pregnancy and till delivery of the fetus. Antepartum hemorrhage~     occurs in 3-5% of pregnancies and is an important cause of perinatal and maternal morbidity~     and mortality worldwide.~      Placenta previa is a placenta inserted wholly or in part into the lower segment of the~     uterus. It is classified by ultrasound to Placenta previa major degree when the lower edge of~     the placenta lies within 2 cm from the internal cervical os and Placenta previa minor degree~     if the lower edge of the placenta at lower uterine segment but more than 2 cm from internal~     os. Placenta previa is responsible for 0.03% of maternal mortality and 8.1% of perinatal~     mortality of 8.1% in the developed world and much more in developing countries.~      Many studies in literature proved the positive correlation between the Placenta previa and~     preterm uterine contractility and also reported that large proportion of women who have~     Placenta previa associated with vaginal bleeding will have subclinical uterine contractions~     before the onset of evident vaginal bleeding.~      There are many tocolytic agents may have a role in conservative management of Placenta previa~     such as magnesium sulfate and β-sympathomimetics .Progesterone is essential for continuation~     of pregnancy and helps in maintenance of pregnancy . Delaying delivery may reduce the fetal~     morbidity by helping maturity of vital organs. In 2003 Meis et al. in a large randomized~     placebo-controlled trial found a significant reduction in recurrent preterm birth before 37~     weeks for women who received 17αHP-C versus a control group receiving placebo (36.3% versus~     54.9%).~   "
33351|NCT03130491|"~     The primary objective is to evaluate the performance and the treatment effect of the use of~     the Emblok embolic protection system use during transcatheter aortic valve replacement with~     respect to procedure-related cerebral embolic burden as determined by DW-MRI.~   "
33352|NCT03130478|"~     This is an observational, retrospective, non-interventional study that will include~     schizophrenic patients who were initiated on AOM treatment during an schizophrenia-related~     hospitalisation at least 6 months before data collection and in a real clinical practice~     setting.~   "
33353|NCT03130465|"~     This is an observational, non-interventional study that will include two cohorts of patients~     with schizophrenia who initiated maintenance treatment during a schizophrenia-related~     hospitalisation: patients who initiated maintenance treatment with aripiprazole once-monthly~     and patients who initiated maintenance treatment with any daily oral atypical antipsychotic.~   "
33354|NCT03130452|"~     The purpose of this study was to evaluate the efficacy and compliance of tailored therapy~     which using the polymerase chain reaction for point mutation of clarithromycin, compared to~     concomitant therapy, in patients without history of H. pylori eradication.~   "
33355|NCT03130439|"~     This research study is studying a drug called Abemaciclib as a possible treatment for have~     metastatic triple-negative type of breast cancer.~   "
33356|NCT03130426|"~     The purpose of the study is to determine whether in patients with early type 2 diabetes, a~     short-term intensive metabolic intervention comprising iGlarLixi, metformin, and lifestyle~     approaches will be superior to standard diabetes therapy in achieving sustained diabetes~     remission.~   "
33357|NCT03130413|"~     The aim of this randomized study is conducted is to evaluate the performance and safety of~     air-Q intubating laryngeal airway as primary airway device in various short surgical~     procedure in children compared to Ambu® AuraGain™ Laryngeal Mask. Current Supraglottic airway~     devices (SADs) available in are classic LMA (cLMA), proseal LMA (pLMA), supreme LMA (sLMA)~     and the newer is Ambu® AuraGain™laryngeal mask. As variety of newer SADs for children have~     emerged since their introduction in clinical practice, hope the outcomes of this study it~     help advancing our knowledge and acumen in selecting appropriate devices for paediatric~     population.~   "
33358|NCT03130400|"~     There is no study to explore the prediction of knee diseases using kinematic parameters of~     knee during gait. The aim of this study is to explore the possibility of predicting knee~     diseases by gait parameters.~   "
33359|NCT03130387|"~     Prevalence of Cesarean Section Niche in women With Unexplained Abnormal Uterine Bleeding~   "
33360|NCT03130374|"~     The trial evaluates the safety and efficacy of the olfactory mucosa-derived mesenchymal stem~     cells based therapy for the patients with chronic laryngeal and tracheal stenosis~   "
33361|NCT03130361|"~     The objective is to assess the impact of a wearable Noninvasive Positive Pressure~     Ventilation, on physical activity and quality of life in patients with severe COPD,~     complaining of dyspnea.~   "
33387|NCT03130023|"~     Oxygen Reserve Index (ORI) is a new parameter for noninvasive monitoring of oxygen reserve~     using oximetry sensor. In this study, we will investigate the correlation between ORI and the~     partial pressure of arterial blood oxygen (PaO2) in children.~   "
33362|NCT03130348|"~     This phase II trial studies how well ibrutinib with or without bortezomib and dexamethasone~     works in treating patients with immunoglobulin light chain amyloidosis that has come back~     after a period of improvement or that does not respond to treatment. Ibrutinib and bortezomib~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~     Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth~     of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Giving ibrutinib with or without bortezomib and dexamethasone may work~     better in treating patients with relapsed or refractory immunoglobulin light chain~     amyloidosis.~   "
33363|NCT03130335|"~     Knee osteoarthritis (OA) is a leading cause of disability. The objectives of treatment are to~     reduce pain, improve function, and slow down further breakdown of the knee. Recently,~     research on nonsurgical treatment options for knee OA has increased significantly. One~     potential treatment of interest is the use of stem cell injections. Stem cells are one's own~     cells that have the ability to divide into other types of cells, and may cause regrowth of~     cartilage when injected into the knee. There have been few, but promising, studies that show~     improvements in pain and function with stem cell injections in those with knee OA. Therefore,~     more research is needed to identify patients who might benefit from this injection. This~     pilot study will look at changes in pain and function for 20 patients at 1, 3, 6, and 12~     months after a stem cell injection into the knee. Patients will also undergo magnetic~     resonance imaging at 6 months and 12 months following the injection.~   "
33364|NCT03130322|"~     This study is designed to determine the neural networks underlying the sleep-related motor~     consolidation process following motor imagery practice. While beneficial effects of sleep are~     expected for sequential movement but not for adaptation motor tasks, the corresponding~     neuroanatomical correlates have not yet been investigated when participants acquired the~     motor tasks through mental practice. Data should substantially promote how designing motor~     imagery interventions targeting (re)learning and/or motor recovery in patients suffering from~     motor disorders.~   "
33365|NCT03130309|"~     The unicompartmental knee prosthesis has become a routine procedure. Survival rate of over~     90% after 10 years are generally reported. However, complications and reoperation may still~     occur for many reasons, and some of them may be related to component design: loosening~     (tibial above), polyethylene wear, knee stiffness, ligamentous instability, etc ... .~     Therefore, new designs can, at least in theory, improve the results of conventional models.~      In this study, the investigators want to compare retrospectively data concerning survival~     rates of patients wearing unicompartmental knee prosthesis with mobile plate for over 10~     years, with the ones published in the literature for conventional fixed-bearing prostheses~     and mobile-bearing prostheses~   "
33366|NCT03130296|"~     This non-interventional study aims to determine whether there is a correlation between the Fc~     receptor polymorphism (FcR) and the course of the disease following HIV infection.~   "
33367|NCT03130283|"~     The project has a threefold aim: (i) Assessment of Home Hospitalization and Early Discharge~     (HH/ED) deployment at Hospital Clinic over a period of 10 years (2006-2015) as a preliminary~     analysis fo the second aim (ii) Large scale deployment of HH/ED and Transitional Care~     services; and, (iii) Population-based study on cost-effectiveness of integrated care services~     in the urban healthcare sector of Barcelona-Esquerra (540.000 inhabitants). The central~     hypothesis is that the approach will show safety and effectiveness with high level of user's~     acceptance and health value generation leading to sustainability of the service.The~     preliminary data indicate that HH/ED shows potential to strengthen care coordination between~     highly specialized hospital-based care and home-based services involving different levels of~     complexity. The need for appropriately designed transitional care services has been~     identified as the best option, not only for an efficient transference of patients from~     hospital to the community after hospital discharge, but as a way to overcome well identified~     limitations for generalization of community-based integrated care services.~      AISBE is a population-based health initiative aiming at deployment of integrated care in one~     urban healthcare sector (Barcelona-Esquerra, 540.000 inhabitants) in the city of Barcelona.~     Within this initiative, the HH/ED program carried out by Hospital Clinic provides home-based~     hospitalization. Moreover, the program aims to implement transitional care strategies for~     optimal discharge.~      The current document describes three studies: (Study 1) Analysis of the period 2006-2015;~     (Study 2) Program-based analysis of Home Hospitalization/Early Discharge (HH/ED) , and,~     (Study 3) Population-based analysis of cost-effectiveness of AISBE-based services. Study 2 is~     a program-based analysis of Home Hospitalization/Early Discharge (HH/ED). A~     quasi-experimental design. That is, a non-randomized intervention group (integrated care)~     will be compared with a control group (usual care) using propensity score matching wherein~     age, gender and health risk scoring will be main matching variables. The population-based~     evaluation will be done using registry data obtained from the Catalan Health Surveillance~     System (CHSS).~      The protocol evaluation follows a Triple Aim approach considering pre-defined outcome~     variables for: a) health and well-being, b) experience with care, and c) costs.~   "
33368|NCT03130270|"~     The study is to evaluate the efficacy and safety of Apatinib for later treatment of~     patients(after second-line treatment for locally recurrent or metastatic nasopharyngeal~     carcinoma), including overall survival (OS), distant metastasis-free survival (DMFS) and~     locoregional relapse-free survival (LRRFS); the relationship between EBV DNA copy number and~     survival after radiotherapy or radiochemotherapy; Quality of life score (QoL); evaluation of~     drug safety.~   "
33369|NCT03130257|"~     Hypertension is usually diagnosed at a clinic or doctor's office when a patient has blood~     pressure (BP) that is high for several measurements. However, about 30 percent of patients~     with high BP in clinics have normal BP outside of clinics. This is called white-coat~     hypertension. Correct diagnosis of hyper-tension is important to prevent strokes, heart~     attacks, and heart failure but also to avoid making people worry or take medicines when they~     don't need to.~      To avoid misdiagnosis of hypertension, the US Preventive Services Task Force (USPSTF), which~     makes national recommendations about disease screening, recommends people should have 24-hour~     BP ambulatory monitoring (i.e., an arm cuff and BP monitor worn for 24 hours, with~     measurements taken every 30 minutes during the day and every 60 minutes at night), with home~     BP monitoring over several days as an alternative. However, most patients have never heard of~     24-hour BP monitoring, and physicians rarely order it. Physicians sometimes use home BP~     monitoring, but not according to recommended guidelines. BP kiosks, for example at drug~     stores, offer another option. Newer models are accurate and easy to use.~      BP-CHECK will identify patients, ages 18 to 85, with high BP at their last clinic visit and~     invite them to a screening visit. Patients with high BP at the screening visit (510 patients)~     will be randomized and assigned to 1) clinic BP, 2) home BP, or 3) kiosk BP diagnostic groups~     for confirming a new diagnosis of hypertension. The clinic BP group will have BP measured at~     two clinic visits. The home BP group will measure BP two times, twice a day, for five days.~     The kiosk BP group will measure BP three times on three separate days at a kiosk at their~     clinic or nearby drugstore. Participants will complete their diagnostic tests over three~     weeks. They will then be asked to complete 24-hour BP monitoring. Participants will complete~     surveys at baseline prior to randomization, after diagnostic tests, and at six months.~      Hypothesis 1: Compared to the reference standard (24-hour BP), home BP and kiosk BP will be~     more accurate than clinic BP. Hypothesis 2: Patients with clinic, home, or kiosk BP results~     concordant with reference standard results will prefer home or kiosk to clinic and 24-hour~     BP. Hypothesis 2: Patients with clinic, home, or kiosk BP results concordant with reference~     standard results will prefer home or kiosk to clinic and 24-hours BP.~   "
33370|NCT03130244|"~     Study will monitor changes in HbA1c for subjects in Intervention arm vs control arm.~   "
33371|NCT03130231|"~     This study evaluated the predictive value of β2-microspheres for postoperative delirium (POD)~     in the elderly after orthopedic surgery. For this purpose, the levels of β2-microspheres in~     plasma and cerebrospinal fluid were compared between the POD and non-POD groups.~   "
33372|NCT03130218|"~     Determine the effectiveness of peppermint oil aromatherapy in relieving post-operative nausea~     in the bariatric surgery patient population.~   "
33373|NCT03130205|"~     The biology of pancreatic neuroendocrine tumors can change during the disease course. This~     evolution of disease can manifest through increases in tumor proliferation rate, resistance~     to medical therapy and/or a change in tumor hormone secretion. This study aims to~     characterize how the biology of pancreatic neuroendocrine tumors change over time, measured~     by; patient symptoms, biochemistry, contrast enhanced computed tomography, FDG-PET and core~     needle biopsy with histopathological analysis (Ki67 index and tumor cell differentiation).~     Uptake on 18F-FDG-PET will be correlated directly to tumor cell proliferation rate. Fraction~     of patients with spatial heterogeneity in FDG uptake as well as metachronous changes in all~     collected data will be documented. Biomaterial from whole blood and core needle biopsies will~     be characterized on the molecular level, and those findings will be integrated to the above~     specified clinical parameters.~   "
33374|NCT03130192|"~     Worldwide, non-small cell lung cancer (NSCLC) is one of the most common causes of cancer~     mortality. Also, the first leading cause of death is lung cancer in Taiwan 2012. Most~     patients are diagnosed at advanced stages and their median survival with supportive care is~     only 3-6 months. The common regimens used on advanced NSCLC treatment consists of~     platinum-based doublet chemotherapy, the survival benefit of which is able to extend the~     survival to approximately 10 months. However, disease and treatment-related toxicities in~     cancer patients may result in fatigue and interfered quality of life (QoL). According to the~     others reports, eight QoL areas including physical functioning, fatigue, pain, and appetite~     loss have been showed a statistically significant association with survival rate of NSCLC~     patients.~      Cancer-related fatigue (CRF), an indicator of QoL, has been reported as the most frequent and~     distressing toxicity of lung cancer chemotherapy. Proposed criteria for CRF have been adopted~     for inclusion in the International Statistical Classification of Disease and Related Health~     Problems, Tenth Revision, Clinical Modification (ICD-10-CM). Therefore, more in-depth~     researches on CRF are needed in Taiwan.~      In addition, electrolyte disturbance like hyponatremia has been reported to be counted as one~     of the many contributing factors for fatigue in palliative care patients and associated with~     poorer overall survival rate (OS) in lung cancer. Thus, the correlation between CRF and~     electrolyte possibly would be a strong link for physician to improve the QoL and survival~     rate of NSCLC patients.~      The objective of this observational study is to evaluate the correlation between CRF,~     survival and physiological factors in NSCLC patients under chemotherapy. The study will~     compare the effect of QoL and CRF on survival with or without CRF treatment and investigate~     the correlation between the variation of CRF and physiological factors which have been~     examined and recorded on medical record under clinical practice. These results will supply~     physicians with more understanding about CRF, and help them to enhance the quality on lung~     cancer care to being perfected in the future.~   "
33375|NCT03130179|"~     This is a research study to verify the same effectiveness and safety profile for the test~     product, Nicorette Strongmint lozenge, as for an already approved product, NiQuitin® Minimint~     lozenge (reference product), in a standardized mode. This verification is done in a so-called~     bioequivalence study, which means that the same amount of the same active substance~     (nicotine), in the same dosage form, for the same route of administration, and meeting the~     same or comparable standards is performed.~      During the study visits, blood samples will be drawn to measure the level of the substance in~     the blood to verify that the two products are comparable. Tolerability of the treatments will~     be evaluated based on reported and observed adverse events.~   "
33376|NCT03130166|"~     Right-sided colonic cancer is treated with right-sided colectomy, predominantly performed as~     minimally invasive surgery with extracorporeal anastomosis (ECA). In recent years a new~     technique with intracorporeal anastomosis (ICA) has emerged and it is thought that ICA is~     less invasive and thereby has the potential to improve the postoperative course of right~     colonic cancer patients.~      The objective of this study is to compare robotic right colectomy with either ICA or ECA in a~     randomized controlled setting.~   "
33377|NCT03130153|"~     There is no evidence based guidelines on using saline rinses for post extraction oral care~     among hypertensives. Similarly, benefit of orally dissolved topical analgesics in addition to~     orally administered analgesic is questionable.~   "
33378|NCT03130140|"~     The technique of macroscopic on-site evaluation (MOSE) has recently been advocated for~     estimating the adequacy of a core specimen for histological diagnosis during EUS-FNA using a~     19-gauge needle. How it compares to the conventional technique of tissue acquisition during~     EUS-FNA is uncertain.~      The objective of this study is to evaluate the quantity and quality of tissue, and the~     diagnostic ability of MOSE when compared with the conventional combined histologic-cytologic~     analysis.~   "
33379|NCT03130127|"~     Terlipressin is the mainstay drug for the treatment of acute variceal bleeding in liver~     cirrhosis. According to the drug instructions, intravenous bolus infusion is the standard~     approach of terlipressin. It remains unclear about whether or not continuous infusion of~     terlipressin should be considered.~   "
33380|NCT03130114|"~     Although the current World Health Organization (WHO) recommended management package for acute~     diarrhoea (ORS, zinc and feeding advice) has contributed to significant reductions in~     diarrhoea associated mortality, over half a million children continue to die annually as a~     result of acute diarrhoeal episodes. In addition, rates of mortality in young children in the~     90 days following an episode of acute diarrhoea appear at least as high as mortality that~     occurs during the acute episode. The long-term benefits of antibiotic administration may~     result from direct antimicrobial effects on pathogens or from other incompletely understood~     mechanisms including improved nutrition, alterations in immune tolerance or improved enteric~     function. Optimizing antibiotic treatment of acute diarrhoea episodes in very young children~     with severe disease may offer the opportunity to significantly reduce diarrhoea associated~     deaths in the 90 days following presentation for acute diarrhoea and may also improve growth.~      The investigators propose to evaluate the efficacy of an antibiotic (azithromycin) delivered~     in a specific, targeted fashion to young children (< 2 years of age) at high risk of~     diarrhoea associated mortality in a multi-site randomized, double-blind, placebo-controlled~     trial. The study will evaluate the ability of the intervention to reduce mortality within 90~     days of the acute diarrhoeal episode, and improve nutritional status over the same period.~   "
33381|NCT03130101|"~     The purpose of this study is to compare the time spent in glucose target range (4.0-10.0~     mmol/L) during exercise and in recovery using three different basal insulin management~     strategies for prolonged aerobic exercise: A) pump suspension for the duration of the~     activity, starting at the onset of exercise; B) A 50% basal rate reduction, performed~     90-minutes in advance of exercise for the duration of the activity; and C) An 80% basal rate~     reduction, performed 90-minutes in advance of exercise for the duration of the activity.~   "
33382|NCT03130088|"~     This study will evaluated the epidemiology and the outcome of patients suffering~     out-of-hospital cardiac arrest in 27 european nations. The special focus in the EuReCa TWO~     study is on bystander CPR.~   "
33388|NCT03130010|"~     In the present study, the investigators evaluated whether nefopam 20 mg reduce the~     catheter-related bladder discomfort in patients undergoing foley catheter insertion~   "
33389|NCT03129997|"~     The objective is to evaluate, in healthy, eutrophic women, if gluten intake influences on~     body weight, basal metabolic rate and macronutrient intake. In a crossover double masked~     model, 30 volunteers will be randomized into two groups, half of them will initiate the~     experiment by taking 2 placebo muffins daily for 3 weeks (Placebo phase) and the remnant~     volunteers will take 2 gluten muffins for 3 weeks (Gluten phase). After one day of wash~     out, the volunteers will be transferred for the other phase to complete 3 more experimental~     weeks.~   "
33390|NCT03129984|"~     The primary objective of this study is to determine the technical failure and inconclusive~     test rates when using the Brizzy device for mandibular movement tracking.~   "
33391|NCT03129971|"~     To objectively analyze the effectiveness of platelet-rich plasma (PRP) combined with~     conventional surgery in the treatment of atrophic nonunion of femoral shaft fractures.~   "
33392|NCT03129958|"~     This study is a cross sectional study conducted to find out the Correlation between neck pain~     and postural abnormalities among female office workers at University of Dammam by objective~     assessments methods.~      Eligible participants will sign the consent form followed by filling up demographic data,~     visual analog scale & neck disability index.~      After that, Forward Head posture and Thoracic Kyphosis posture will take place by valid and~     reliable methods.~   "
33393|NCT03129945|"~     The purpose of this research study is to determine the best medication to stop preterm labor.~     Recent studies have identify nifedipine and indomethacin as the two medications that are most~     likely to delay delivery for 48 hours, decrease maternal side effects and decrease some~     complications related to preterm delivery to the neonate. Both of these medications are~     commonly used to stop pre-term labor, therefore it has become our institution's standard to~     use these two medications in the setting of preterm labor. There have been limited studies~     comparing these two medications directly.~      A total of 450 participants will be asked to participate across all study sites.~   "
33394|NCT03129932|"~     This is a double-masked, crossover, randomized, controlled study that aims to evaluate, in~     women with obesity, a possible influence of wheat gluten on food choices, body weight,~     resting metabolism and circulating inflammation markers and adipokines. The volunteers will~     be randomized into two groups, half of them will initiate the experiment by taking 2 placebo~     muffins daily for 4 weeks (Placebo phase) and the remnant volunteers will take 2 corn muffins~     containing 12g of gluten/each for 4 weeks (Gluten phase). At the 1st, 4th and 8th~     experimental weeks will be evaluated body weight, body composition, lipid profile, glucose,~     insulin, leptin, adiponectin, and inflammatory markers.~   "
33395|NCT03129919|"~     It is intended to evaluate changes in arch dimensions and incisor inclination as well as~     changes in the WALA Ridge in no extraction patients treated with interactive self-ligating~     brackets (Empower®) and passive (Carriere SLX®) at the end of the phase of alignment and~     leveling. For this, study models and profile radiographs taken before the start of treatment~     and at the end of the alignment and leveling phase will be evaluated. The parameters to be~     measured are: intercanine distance, arch depth, upper and lower incisor inclination, and WALA~     ridge analysis~   "
33396|NCT03129906|"~     The aim of this study is to evaluate the impact of gluten-free diets on symptoms and~     inflammatory markers in individuals with previous diagnosis of fibromyalgia (FM), as well as~     to identify the presence of non-celiac gluten sensitivity (NCSG) in individuals with FM.~     Patients with FM diagnosis will be kept on a gluten-free diet for a 10 weeks. In the 7th~     week, they will receive placebo capsules for 7 days and after washout, capsules containing~     gluten for another 7 days. A questionnaire based on Salerno protocol will be applied to~     evaluate the presence of NCGS in the beginning, 8th week and 10 week.~   "
33397|NCT03129893|"~     Ventilator associated pneumoniae (VAP) occurs in 9-27% of all intubated patients and is~     associated to an important morbidity and mortality. It is a serious complication among~     neonates and pediatric patients after cardiac surgery accounting for 6.8 - 32.2 % of~     health-care associated infections. It has a large impact on morbidity, survival, hospital~     costs and duration of neonatal and pediatric intensive care unit stay (PICU). Ventilator~     associated tracheobronchitis (VAT) is common in adults and it has been described as a risk~     factor for the development of VAP. Studies have shown that treatment of VAT is associated~     with a lower rate of VAP and a lower mortality in adult critically ill patients. VAT has also~     been described in premature infants and children but it has been less studied than in adults.~      Recently the Centers for Disease Control and Prevention (CDC) rolled out new surveillance~     definitions for patients receiving mechanical ventilation that promise to dramatically~     improve hospital's capacity to track clinically significant complications in this population.~     These new surveillance definitions were designed to be more objective and to render the data~     easier to collect and verify. The terms include ventilator-associated condition (VAC) and~     infection-related, ventilator-associated complication (IVAC). Studies in adults demonstrated~     that the VAC assessment was faster, more objective, and a superior predictor of outcomes.~     However, this approach has not yet been applied systematically to infants and children.~      For more than 50 years, uncuffed tracheal tubes have been commonly used for intubation in~     children under 8 years of age because of the anatomy of the pediatric larynx and the fear~     (based on case reports and scruples) that the cuff will cause airway mucosal injury, leading~     to subglottic stenosis. However, since 2009, it is registered and available a new cuffed~     tracheal tube (TT) (Microcuffw PET; Kimberly Clark, Health Care, Atlanta, GA, USA) with an~     anatomically designed high volume - low pressure tube cuff, with a recommendation chart for~     tube size selection has recently become available for pediatric anesthesia.~      Weiss and colleagues enrolled 2246 patients in a randomized multi-centre trial and reported~     no increase of risk for post-extubation stridor with the use of the new microcuffed.~      Considering that microaspiration of contaminated oral secretions is one of the mechanisms~     leading to VAP and VAT, the use of cuffed TTs may be beneficial in VAP prevention as the~     superior tracheal seal may decrease the incidence of micro-aspiration. However, no study~     evaluated the incidence of VAP with the use of cuffed tracheal tubes is published since now.~      Despite of these new evidence, the use of uncuffed tube in neonatal and pediatric critical~     care still remain very common to minimize minor complications (i.e. mucosal damage due to the~     cuff), and consequently the use of cuffed or uncuffed tubes is equally recommended.~      The management of anesthesia according to standards procedures of the Bergamo anesthesia~     department is shifting from the uncuffed tubes only to microcuffed tubes, and it is aim of~     the present study to monitor this transition measuring the performance of the two TTs in~     terms of incidence of VAP and VAT (according to the CDC old definition) and in term of~     incidence of VAC and IVAC (according to CDC new definition).~   "
33398|NCT03129880|"~     The purpose of this study is to determine if there are differences in treatment outcomes~     between traditional voice therapy, performed weekly for a maximum of 6 weeks versus intensive~     voice therapy, consisting of 4-6 therapy sessions performed within one day.~   "
33399|NCT03129867|"~     Ticagrelor 90 mg twice daily treatment is recommended for 12 months in patients with acute~     coronary syndrome (ACS) and in patients undergoing coronary revascularization and~     conservative strategies. Recent data from the PEGASUS-TIMI 541 trial have shown that~     long-term treatment with ticagrelor reduced the risk of major cardiovascular adverse events~     (MACE) in stable ambulatory patients with a history of myocardial infarction. Based on these~     data, prolongation over 12 months of ticagrelor therapy could be indicated in selected~     patients; even if with such a prolongation some adverse effects on the treatment could be~     observed. In the PLATO2 trial, where median duration of exposure to the study drug was 277~     days, the suspension of ticagrelor therapy was 7.4% in ticagrelor versus 6% in patients~     receiving clopidogrel ( P <0.001). Ticagrelor treatment interruption was mainly driven by~     non-serious adverse events occurring mainly shortly after randomization. For patients after~     the first year of treatment, the subsequent rate of interruption was low. These data~     demonstrate that adverse events considered not serious by traditional trial criteria may~     have an effect on quality of life and, therefore, can cause treatment interruption; The~     phenomenon emphasizes at the same time the importance of patient education and advice on~     timing and the nature of adverse effects in order to improve adherence. Patients in the real~     world may show a premature suspension rate of the drug even higher than in clinical trials.~     However, data from real-world patients is scarce.~   "
33400|NCT03129854|"~     Patients with primary diagnosed metastatic prostate cancer are randomly divided into two~     groups. One group receive standard of care ADT continually. Another group receive ADT plus~     prostate cryotherapy. Patients are followed up until their death or withdraw from this study~     due to other reasons. The primary endpoint of this study is prostate cancer Progression-Free~     Survival. The secondary endpoint is overall survival, prostate cancer specific survival and~     health-related quality of life.~   "
33401|NCT03129841|"~     The aim of the present study is to test whether late eating dinner could affect the amount of~     weight loss in healthy obese women in a weight-loss program.~   "
33412|NCT03129698|"~     52 patients with extensive-stage small-cell lung cancer and without progression after~     completing chemotherapy, will receive apatinib monotherapy as maintenance therapy.~   "
33413|NCT03129685|"~     Assessment of short-term outcomes of ipsilateral lobe arterial devascularization of the large~     hepatocellular carcinoma: single center non-randomized trial.~   "
33402|NCT03129828|"~     The ImbruVeRCHOP-Trials is an Investigator-initiated, single-arm, multi-center, prospective,~     open phase I/II trial to evaluate the efficacy and feasibility of Ibrutinib and Bortezomib in~     the therapy of higher-risk DLBCL patients of different molecular subtypes and to correlate~     outcome with clinical, molecular and imaging-guided response parameters. The protocol~     includes a safety run-in phase, i.e. the phase I part of the study, to uncover unexpected~     toxicities that may arise in the context of Ibrutinib and Bortezomib co-administered with the~     R-CHOP backbone. The safety run-in phase is followed by the phase II part of the trial. About~     60 patients will be included over 3 years. Additional 8-11 German university centers will~     participate in this trial. The study treatment includes a pre-phase therapy with Prednisone~     and 6 cycles of a combined immuno-chemotherapy with the anti-CD20 antibody Rituximab together~     with 6 cycles of a chemotherapy consisting of Cyclophosphamide, Doxorubicin, Vincristine and~     Prednisone plus Bortezomib and Ibrutinib followed by two additional 3-week cycles of~     Rituximab. Secondary endpoints are the predictive power of subtypes (such as~     GCB/ABC-cell-of-origin), markers of minimal residual disease over time and~     during-the-study-determined markers (e.g. gene signatures) to identify patients who benefit~     from this treatment addition.~   "
33403|NCT03129815|"~     The failure of extubation in pediatric resuscitation is most often described as the need for~     reintubation within 48 hours after extubation. The failure rate of extubation in pediatric~     intensive care varies in the literature there is between 4 and 22% failures. These failures~     result in increased mortality, morbidity with a use of larger tracheostomy, a prolonged~     residence time. The extubation is codified in adult resuscitation and tends to be~     increasingly in pediatric resuscitation. In the pediatric intensive care unit of Hautepierre,~     a extubation protocol already exists for some time, and was prepared to go. the current~     literature data. It allows the harmonization of practices in service (previously left to the~     discretion of each doctor).~      The investigators are looking to see if the protocol used systematically in the service~     enables a reduction in the incidence of occurrence of failures of extubation.~   "
33404|NCT03129802|"~     The failure of extubation in pediatric resuscitation is most often described as the need for~     reintubation within 48 hours after extubation. The failure rate of extubation in pediatric~     intensive care varies in the literature there is 4 to 22% failure. These failures result in~     increased mortality, morbidity with a use of larger tracheostomy, a prolonged residence time.~     Some risk factors are well defined in the literature as the duration of intubation, ENT and~     neurological history, the persistence of a respiratory disease, a high level of sedation.~     Other factors are more controversial as age, ventilatory parameters just before extubation~     before extubation blood gases, the interest of a leak test.~      Also pediatric populations are extremely heterogeneous, so the investigators would like to~     highlight to extubation failure risk factors in Hautepierre pediatric ICU to better support~     these high-risk children.~   "
33405|NCT03129789|"~     Monitoring fluid balance is crucial in the care of critically ill children. There are several~     reasons urine output could be decreased. For example, the bladder could be empty because the~     patient isn't making urine due to dehydration, or the bladder could be full but the patient~     unable to urinate due to obstruction of the bladder outlet. It is prudent to distinguish this~     difference in the care of Pediatric Intensive Care Unit patients as the potential~     interventions vary and none is without potential drawbacks if used inappropriately. At~     present, there is no standard way to determine whether an oliguric patient has a bladder that~     is under- or over-filled. Bedside ultrasound is safe, non-invasive, painless, and relatively~     quick and can help assess bladder volume at the time of noted oliguria. Several studies in~     pediatrics endorse the use of ultrasound to approximately measure urine volume. Pediatric~     residents are frequently asked to manage patients' oliguria in the Pediatric Intensive Care~     Unit, however, they are not currently being trained how to use ultrasound to measure bladder~     volume. The investigators hypothesize that following a structured learning plan, by the end~     of their one-month Pediatric Intensive Care Unit rotations, pediatric residents will be able~     to independently and accurately measure bladder volume by ultrasound. Volumetric bladder~     ultrasound is an easily mastered bedside imaging technique. Its implementation could~     positively affect care of the critically ill infant or child.~   "
33406|NCT03129776|"~     The purpose of this study is to image tumour lactate in study participants with locally~     advanced cervical cancer. Our hypothesis is that lactate content in cervical tumours, as~     measured by hyperpolarized 13C Magnetic Resonance (MR) imaging, will correlate with~     diffusion-weighted MRI and 18FDG-PET (fluorodeoxyglucose-positron emission tomography).~     Furthermore, lactate imaging will potentially provide additional and more specific~     information regarding the metabolic activity of cervical tumours, thereby identifying regions~     of radiation resistance and guiding radiation treatment and brachytherapy.~   "
33407|NCT03129763|"~     The purpose of this study is to optimize the expansion pressure by compare different capsule~     pressures' effect, the blood supply of expanded skin is assessed by the Indocyanine Green-SPY~     Angiography.~   "
33408|NCT03129750|"~     The study is aimed at collecting preliminary safety and efficacy data related to the use of~     Drug Coated Balloon (DCB) technology for the treatment of symptomatic Superficial Femoral~     Artery (SFA) ischemic vascular disease in patients presenting with long lesions.~      The present clinical evaluation is intended as a prospective observational data collection of~     patient treatment in full accordance with institution standard practice and utilizing an~     approved (CE marked) DCB currently available on the market.~   "
33409|NCT03129737|"~     Patients elected to undergo mitral valve surgery (either repair or replacement) with less~     equal than moderate (≤+2) tricuspid regurgitation and dilated tricuspid annulus (>21mm/m2) at~     preoperative echocardiography will be screened. Consenting patients fulfilling all inclusion~     and exclusion criteria will be included in the study and assigned to elective mitral valve~     replacement or repair with or without concomitant tricuspid annuloplasty in a 1:1 fashion,~     using a blocked randomization scheme balanced within center.~   "
33410|NCT03129724|"~     Describe in patients with metastatic kidney cancer treatment modalities with the type~     sequences: TKI - mTORi - Axitinib or VEGF mAb - mTORi - Axitinib.~   "
33411|NCT03129711|"~     The most frequent reason for failure of laminate veneers made of glass ceramics (feldspathic,~     leucite based and lithium silicate based ceramics) was fracture of the ceramic, Therefore,~     ceramic materials that have higher fracture resistance, especially for patients suffering~     from abnormal occlusion, are needed.~   "
33415|NCT03129659|"~     Current evaluation of patients suspected of non-ST-elevation acute coronary syndrome is~     greatly dictated by the results of high-sensitivity troponins. In a substantial number of~     patients this approach does not provide a conclusive work-up. Patients typically present with~     slightly elevated high-sensitivity troponins without significant changes during serial~     sampling and no other clinical clues that can aid in determining the etiology of their chest~     pain complaints. Uncertainty remains about the optimal diagnostic management of these~     patients and they are often admitted to undergo invasive angiography. Coronary CT angiography~     can improve efficiency of clinical care in these patients by reducing unnecessary hospital~     admissions and invasive angiography. In this study, the investigators will investigate~     whether a diagnostic strategy comprising of early coronary CT angiography is more clinically~     efficient than standard optimal care in patients with an inconclusive work-up for~     non-ST-elevation acute coronary syndrome.~   "
33416|NCT03129646|"~     This is an open label, Phase III, randomized, controlled, parallel arm multicentre~     non-inferiority clinical trial to compare the efficacy and safety of two combination regimens~     of Miltefosine and Paromomycin with the standard SSG-PM for the treatment of primary adult~     and children VL patients in Eastern Africa.~   "
33417|NCT03129633|"~     This study examines the effectiveness of a community health worker (promotores) network in~     improving access to care, social support, physical activity and nutrition in Latino~     immigrants living in an emerging Latino community.~   "
33418|NCT03129620|"~     Controlled Hypothermia has become the standard of care for neonates with moderate to severe~     HIE. Ampicillin and aminoglycosides are drugs that are universally used for the treatment of~     suspected neonatal sepsis, which may or may not be responsible for the etiology of HIE.~     Currently, medication dosage regimens are not altered in the setting of CH. A better~     understanding of the effects of our interventions on this unique population may help us~     tailor our therapy to the specific circumstances of the patient~   "
33419|NCT03129607|"~     The International Study Group of Pancreatic Surgery (ISGPS) issued the definition and~     classification system of postoperative pancreatic fistula (POPF), and received widespread~     recognition. Currently, it has become an important reference for clinical treatment of POPF.~   "
33420|NCT03129594|"~     GLP-1(9-36) amide and (9-37), which was previously thought to be the inactive metabolite of~     GLP-1, also exerts cardioprotective effects. Direct administration of GLP-1(9-36) during~     reperfusion reduced ischaemic damage in isolated hearts and increased cGMP release,~     vasodilatation and coronary flow in AMI mouse model, one may speculate that total GLP-1 level~     may associate with adverse cardiovascular events in AMI patients, the hypothesis is therefore~     tested in this study.~   "
33421|NCT03129581|"~     The investigators are interested in how time-restricted feeding will impact weight, sleep~     duration and efficacy, and activity levels in obese adults. Significant advances in digital~     mobile technology allow detailed measures of an individual's habits, permitting the~     opportunity for personalized dietary and lifestyle recommendations. This is especially~     relevant as time-restricted feeding appears to promote weight loss independent of calorie~     intake, potentially shifting the paradigm of dietary recommendations from a calorie-based to~     a time-based perspective.~   "
33422|NCT03129568|"~     A phase 1 randomized-controlled study to determine the procedural feasibility and safety and~     preliminary efficacy of intracoronary infusion of cardiosphere-derived cells (CDCs) in~     patients with dilated cardiomyopathy.~   "
33423|NCT03129555|"~     No randomized head-to-head comparison between the individual Non-vitamin K Antagonist Oral~     Anticoagulants (NOAC) exists. The DANNOAC-VTE study is a nationwide cluster randomized~     cross-over study comparing efficacy and safety of the four NOACs, edoxaban, apixaban,~     rivaroxaban and dabigatran for oral anticoagulation in venous thromboembolism across Danish~     hospitals.~   "
33424|NCT03129542|"~     The investigators would like to determine if early administration of oral Midodrine in~     participants diagnosed with sepsis will impact blood pressures and decrease the need for~     and/or doses of intravenous pressor agents.~   "
33425|NCT03129529|"~     The main purpose of this study is to compare treatment efficacy of focused and radial~     extracorporeal shock waves on spasticity in chronic stroke patient~   "
33426|NCT03129516|"~     Motor imagery is the mental representation of movement without any body movement. According~     to recent studies motor imagery contains three strategies to mentally simulate the movements:~     internal visual, external visual and kinesthetic imagery. Motor imagery is associated with~     cortical reorganization and functional improvements and it does not only related with motor~     performance, it also influces cognitions. Movement Imagery Questionnaire-3 (MIQ-3) is the~     recent, modified version of the Movement Imagery Questionnaire-Revised, Second Edition and~     measures imagery ability in terms of ease of imagery.~      The aim of this study is to translate MIQ-3 into Turkish and evaluate its test-retest~     reliability for Turkish-speaking population.~   "
33427|NCT03129503|"~     The OPTICO-ACS- study program - combining for the first time in vivo characterization of the~     ACS-causing culprit lesion by intracoronary imaging technique with optical coherence~     tomography (OCT) and molecular analysis of immune-cells derived from the culprit coronary~     thrombus and biochemical analyses in patients with acute-coronary-syndrome (ACS).~   "
33428|NCT03129490|"~     No randomized head-to-head comparison between the individual Non-vitamin K Antagonist Oral~     Anticoagulants (NOAC) exists. The DANNOAC-AF study is a nationwide cluster randomized~     cross-over study comparing efficacy and safety of the four NOACs, edoxaban, apixaban,~     rivaroxaban and dabigatran for oral anticoagulation in non-valvular atrial fibrillation~     across Danish hospitals and cardiology clinics.~   "
33451|NCT03129191|"~     Recently, a new non-invasive bone conduction hearing aid was introduced. The system is~     connected directly to the skin with an adhesive adapter to transmit the sound to the inner~     ear through bone vibrations. The objective of this study is to evaluate and compare the~     audiological benefit of the new bone conduction hearing aid and compare it to an existing~     bone conduction hearing aid in normal hearing adults with bilateral simulated conductive~     hearing loss.~      An evaluation of the improvement on speech understanding in noise and sound localization~     allows to estimate the system performance and enables to derive recommendations for clinical~     usage of the novel hearing system. It is hypothesized that in the bilateral condition similar~     speech understanding in noise and sound localization performance can be achieved with the new~     system compared to existing bone conduction hearing aids that are pressed against the skull~     using a soft band.~   "
33429|NCT03129477|"~     COPD is the fourth cause of death worldwide and it is expected to be the third in 2020.~      Non-invasive ventilation (NIV) has a positive impact in reducing mortality related to chronic~     respiratory failure in stable patients with COPD. Moreover, the addition of home NIV to home~     oxygen therapy reduces hospital admissions and improves patients outcomes.~      Patients monitoring is crucial. It is increasingly recognized the potential of telemedicine~     in reducing morbidity and mortality, as well as healthcare utilisation and its associated~     costs. In particular, home telemonitoring (TM)- a technology measuring patients`clinical~     parameters and symptoms at home and allowing communication between healthcare professionals~     and patients over distance- has gained much attention. However, despite a growing body of~     evidence for TM in the management of COPD and other chronic diseases, the benefit of~     telemonitoring for Home mechanical ventilation concerning clinical and economic outcomes~     remains to be clearly demonstrated.~      The study aims to assess the impact that telemonitoring would have NIV efficacy, patient~     quality of life and satisfaction, through a prospective randomized study.The primary endpoint~     is the time for appropriate adaptation and therapy efficacy, defined as average SatO2 to 90%~     in 24h oximetry.~   "
33430|NCT03129464|"~     This is a pilot randomized controlled trial examining post-operative pain scores and outcomes~     after laparoscopic hysterectomy in patients prescribed cold therapy as an adjunct to routine~     post-operative multi-modal analgesia, compared to those patients prescribed routine~     multi-modal analgesia without cold therapy. All patients scheduled for total laparoscopic~     hysterectomy (without robotic-assistance) will be screened for eligibility in the study. If~     eligible, patients will be invited to participate in the study and standardized informed~     consent process will ensue. After surgery is completed participants will be randomized to~     either the control group or the study group. The study group will be prescribed the use of~     cold therapy to their abdominal incisions through reusable cold gel packs. The cold therapy~     is to be applied to participants' incisions for the first three postoperative days, in~     addition to routine post-operative analgesia regimen. Investigators will then collect~     information on pain scores, narcotic use, quality of life and surgical recovery scores.~      This study aims to examine if there is a difference in post-operative pain scores with the~     application of cold therapy to laparoscopic abdominal incisions following laparoscopic~     hysterectomy, when compared to no cold therapy. Secondarily, investigators will examine~     post-operative quality of life scores, postoperative surgical recovery scores, as well as~     narcotic use among the two groups. Investigators also aim to ascertain additional information~     regarding total quantity of narcotics used post-operatively to aid in prescribing patterns.~   "
33431|NCT03129451|"~     To investigate the dynamic relationship between the intestinal microbiota and Inflammation in~     subjects with Parkinson's disease.~   "
33432|NCT03129438|"~     Continuous video-EEG monitoring (cEEG) significantly improves seizure or status epilepticus~     detection in patients in intensive care units (ICUs), and is recommended for patients with~     consciousness impairment. cEEG is time- and resource consuming as compared to routine EEG~     (rEEG, lasting 20-30 minutes). While centers in North America have been using it~     increasingly, most European hospitals still do not have resources to comply with these~     guidelines. In addition, only one population-based study based on discharge diagnoses~     suggested that cEEG may improve patients' outcome. Current guidelines are thus based upon~     weak evidence and expert opinions.~      Aim of the study is to assess if cEEG in adults with consciousness impairment is related to~     an improvement of functional outcome, and to address the prognostic role of quantitative~     network EEG analyses.~      In this multicenter randomized controlled trial, adults with GCS inferior or equal to 11 or~     FOUR score inferior or equal to 12 will be randomized 1:1 to cEEG for 30-48 hours or two rEEG~     within 48 hours. The primary outcome will be mortality at 6 months. Secondary outcomes will~     blindly assess functional outcome, seizure/status epilepticus detection rate, duration of ICU~     stay, change in patient management (antiepileptic drug introduced, increased, or stopped,~     brain imaging), and reimbursement. Additionally, quantitative EEG will be assessed towards~     the primary outcome. 350 patients are planned to be included.~   "
33433|NCT03129425|"~     The aim of this study is to evaluate the effects of a psychoeducational multidisciplinary~     intervention focusing on improving coping skills, the psychosocial adaptation to Parkinson's~     disease and the quality of life in patents and family carers in a Primary Care setting.~      On the basis of previous research, the hypothesis we propose is that through the development~     of coping skills which will contribute to promoting a positive psychosocial adaptation to~     Parkinson' disease, the quality of life of the people with Parkinson's disease and their~     family carers will be improved. At the same time, it is predicted that, by incorporating this~     psychoeducational intervention into clinical practice, the patients and family caregivers~     will perceive a greater sense of normality in their lives, which will also promote compliance~     with drug treatments and promote healthy lifestyles. In the long-term, such an approach could~     have positive effects on the overall health of patients and their family carers.~      This quasi-experimental study with control group and mixed methods was designed to evaluate~     the ReNACE psychoeducational intervention (ReNACE is the spanish acronym for the Research~     Programme and means Recovery, Normalisation, Acceptance and Living with Chronic illness).~     Based on the relevant study power calculations, 100 people with Parkinson's disease and 100~     family carers will be recruited. Participants will be assigned to two groups. The~     intervention group will receive the ReNACE psychoeducational intervention. The control group~     will be given a general educational program. The study will be carried out in community-based~     health centers. The results obtained from the two groups will be evaluated at three time~     points: at baseline, immediately after the intervention and at 6 months after the~     intervention. The results will be measured with the following instruments: the Quality of~     Life Scale PDQ-39 (The 39-item Parkinson's Disease Questionnaire) for patients and the~     Quality of Life Scale for caregivers SQLC (Scale of Quality of Life of Caregivers) for family~     carers, and for patients and family carers the Psychosocial Adjustment to Illness Scale~     Self-report (PAIS-SR) and the Brief Cope Inventory. To determine the acceptability of the~     intervention, focus groups will be organized with some patients and family carers who have~     received the ReNACE intervention and also with the healthcare professionals involved in its~     development.~   "
33434|NCT03129412|"~     Oligo-metastases NPC patients received radiation for primary tumors and treatments for~     metastatic lesions.~   "
33435|NCT03129399|"~     This study was designed to determine the comparison between the King Vision video~     laryngoscope and McGrath MAC video laryngoscope for nasotracheal intubation.Patients were~     divided into 2 groups of 40 patients each.Patients of King Vision group [n=40]and Macintosh~     group [n=40]were intubated using respective devices.This study is the first to search the use~     of King Vision video laryngoscope for nasotracheal intubation in difficult airway.~   "
33436|NCT03129386|"~     This study is investigating the normal range of maximal diaphragm thickness during a sniff~     inspiratory manoeuvre using ultrasound in healthy subjects stratified by age and gender.~   "
33437|NCT03129373|"~     The present study was set-up to evaluate clinical efficacy of Pixie® cryogenic pen versus two~     comparator cryogenic products (Wartner® and Wortie®) for the treatment of common and plantar~     warts.~   "
33438|NCT03129360|"~     In order to establish target engagement and identify an effective dose the investigators will~     conduct a placebo-controlled single-dose parallel group trial of levetiracetam 185 mg and 500~     mg in 24 medication-naïve early psychosis (EP) patients, measuring hippocampal activity by~     pulsed arterial spin labelling (ASL) pre-dose and 2 hours post-dose. The lower dose is~     calculated to achieve blood levels within the range that were associated with reduced~     hippocampal activity and improved cognition in patients with mild cognitive impairment; the~     higher dose is a typical antiepileptic dose. Successful demonstration of target engagement~     will be defined by an effect size of 0.5 or greater compared to placebo in reduction by~     levetiracetam of hippocampal blood flow measured by ASL. The optimal dose will be defined by~     maximal reduction of hippocampal perfusion in the absence of clinically-significant adverse~     effects. The investigators will also study 8 healthy control subjects to verify that baseline~     hippocampal blood flow is elevated in the sample of FEP subjects.~   "
33439|NCT03129347|"~     This study will be to compare the pharmacokinetics of nalmefene administration intranasal~     with and without an absorption enhancer compared to an intramuscular injection.~   "
33440|NCT03129334|"~     This project is designed to test a primary prevention approach to the problem of prescription~     drug misuse and abuse (PDA) among middle school students. The intervention uses both online~     e-learning and small group facilitator-led intervention modalities. Middle schools will be~     randomized to receive the intervention or serve as controls.~   "
33441|NCT03129321|"~     To evaluate the therapeutic equivalence of the Test formulation, econazole nitrate cream, 1%~     to the Reference product, econazole nitrate cream, 1% in the treatment of tinea pedis.~      To demonstrate the superiority of the Test and Reference (active) treatments over Placebo~     treatment in patients with tinea pedis.~      To compare the safety of Test, Reference and Placebo treatments in patients with tinea pedis.~   "
33442|NCT03129308|"~     The spectrum of reported autoimmune phenomena in HIV infected patients is unexpectedly broad~     and - owing to the current efficacious treatment regimes - increasing. The likelihood of the~     occurrence of autoimmune phenomena correlates with a high CD4 count, consequently they are~     found most frequently soon after infection or after immune reconstitution. It is likely that~     recent developments, namely the recommendation to treat all patients regardless of their CD4~     count, may lead to a further increase in autoimmune phenomena in HIV infected patients. In~     contrast to the abundance of data of rheumatological and hematological autoimmune disease in~     HIV infected patients, no systematic study exists which has analyzed the prevalence of~     autoimmune blistering disease and/or associated autoantibodies in these patients.~      The investigators therefore intend to determine the prevalence of selected autoantibodies in~     our HIV cohort in relation to uninfected controls. According to recent guidelines, all HIV~     infected patients should receive anti-retroviral treatment at the earliest time point~     possible, making the restoration of the immune system more likely and leading to a further~     alignment of the life expectancy relative to age matched, uninfected controls. As a~     consequence, the incidence of AIBD, especially of bullous pemphigoid, for which age is the~     single most important risk factor, may rise.~      In total, knowledge about the prevalence of AIBD specific auto antibodies might be supportive~     in the diagnosis of these conditions in the future.~   "
33443|NCT03129295|"~     A study of the efficacy and safety of MPC-SHRC for the relief of symptoms associated with~     uncomplicated urinary tract infections.~   "
33444|NCT03129282|"~     Depression and anxiety are highly prevalent in people with heart disease, causing immense~     human and economic burden. Available pharmacological and psychological interventions have~     limited efficacy and the needs of these patients are not being met in cardiac rehabilitation~     services despite emphasis in key NHS policy.~      Extensive evidence shows that a particular style of thinking dominated by rumination~     (dwelling on the past) and worry maintains emotional distress. A psychological intervention~     called metacognitive therapy (MCT) that reduces this style of thinking alleviates depression~     and anxiety in mental health settings.~      This is a single-blind feasibility randomised controlled trial of metacognitive therapy~     delivered in a home-based format (Home-MCT). The aim of the study is to evaluate the~     acceptability and feasibility of integrating Home-MCT into cardiac rehabilitation services~     and to provide provisional evidence of effectiveness and cost-effectiveness on Home-MCT.~   "
33445|NCT03129269|"~     The current study seeks to examine the prevalence of amyloid pathology, among patients~     referred to the Toulouse Geriatric Frailty Clinic presenting objective memory impairment. We~     also aim to fully characterize the clinical progression of frail cognitively impaired~     patients presenting AD (Alzheimer Disease) pathology vs those who also present a cognitive~     impairment but do not have AD pathology.~   "
33446|NCT03129256|"~     This study is to explore the potential efficacy and safety of low-dose Apatinib combined with~     S-1 in patients with advanced lung cancer. Patients with advanced NSCLC will be treated with~     oral apatinib and S-1 after treatment failure of standard regimen.~   "
33447|NCT03129243|"~     In the current era of assisted reproductive techniques where technology can help overcome~     defects in sperm function, the value of semen analysis has become even more inaccurate.~     Initial reports of intracytoplasmic sperm injection revealed its ability to bypass the~     natural selection process and enable men with severely impaired semen parameters to achieve~     both clinical pregnancy and live birth~   "
33448|NCT03129230|"~     This study was to evaluate the safety and efficacy of free nonvascularized fibula autograft~     in the treatment of the femoral neck tumor-like lesions before epiphyseal closure in~     pediatric patients, by presenting the clinic-radiological outcome and complications.~   "
33449|NCT03129217|"~     This study is designed to determine whether maximal diaphragm thickening fraction measured by~     ultrasound during volitional maximal inspiratory efforts is a valid measure of diaphragm~     function in mechanically ventilated patients.~   "
33450|NCT03129204|"~     The purpose of the feasibility study is prevention of Post Intensive Care Syndrome in Family~     (PICS-F), specifically in spouses of critically ill, mechanically ventilated patients, using~     a nonpharmacological intervention called Sensation Awareness Focused Training (SĀF-T). This~     will be accomplished using a prospective, randomized, experimental design to achieve robust~     and unbiased results.~   "
33593|NCT03127189|"~     The main purpose of this study is to characterize the single-dose pharmacokinetics (PK) of~     rilpivirine (RPV) after intramuscular (IM) injection of rilpivirine long-acting parenteral~     formulation (RPV LA) nanosuspensions with different particle size distribution (PSD), in~     healthy adult participants.~   "
33452|NCT03129178|"~     Individuals with Raynaud's phenomenon often experience episodes of reduced blood flow to~     their fingers and toes during times of stress or cold exposure, causing significant~     discomfort and pain. Typically, treatment for these individuals involves using drugs like~     Glyceryl Trinitrate (GTN), which increases blood flow to the fingers and toes by increasing a~     substance called nitric oxide in the blood. Unfortunately, repeated use of these drugs~     increases tolerance to them, meaning higher doses are required to produce the same effect.~     However, increasing the dose can cause more side effects like headaches, and is therefore not~     considered an ideal long-term therapy.~      Leafy green vegetables, especially beetroot, contain high amounts of nitrate and are~     beneficial to blood vessel health, since nitrate from the diet can also be turned into the~     important blood vessel relaxer, nitric oxide. Unlike GTN, people don't appear to develop a~     tolerance to dietary nitrate or experience negative side effects.~      Therefore, this study aims to see if short and longer term beetroot juice supplementation can~     improve blood flow to the hands and feet in individuals with Raynaud's phenomenon, as well as~     reduce their pain. This study will tell us how many people are needed for a definitive trial~     investigating whether beetroot juice can help treat Raynaud's phenomenon.~      Raynaud's phenomenon can cause significant discomfort and pain to individuals. Dietary~     nitrate appears to offer a simple, low cost means of improving blood flow to the hands and~     feet which should reduce both the discomfort and pain experienced characterising this~     condition. This study will advance our understanding of the causes of Raynaud's phenomenon,~     specifically the role that the nitrate-nitrite-nitric oxide pathway might play in changing~     Raynaud's phenomenon symptoms and identifying targets for intervention.~   "
33453|NCT03129165|"~     The purpose of this study is to determine the efficacy and cost/effectiveness (change in CV~     risk factors and lifestyle vs costs) of ProSALUTE as a new organizational model of primary CV~     prevention.~   "
33454|NCT03129139|"~     A Phase I, Multicenter, Open-label, Dose-Escalation, Safety, Pharmacokinetic and~     Pharmacodynamic Study of Minnelide™Capsules given daily for 21 days followed by 7 days off~     schedule in patients with Advanced Solid Tumors~   "
33455|NCT03129126|"~     The purpose of this study is to assess the safety and tolerability of three doses of LP-10~     (intravesical tacrolimus) compared to placebo. Eighteen subjects meeting the inclusion and~     exclusion criteria will be enrolled and treated in a prospective, doubleblind, randomized,~     placebo controlled, and multicenter trial with LP-10. The proposed trial will recruit 18~     subjects in a dose-escalation trial where 6 subjects will be allocated into each one of three~     groups.~   "
33456|NCT03129113|"~     This is a multicentre, phase IV, randomised, open-label, trial exploring adjunctive maraviroc~     and/or metformin for liver steatosis over 48 weeks.~      Sponsored by University College London Coordinated by MRC Clinical Trials Unit at UCL~   "
33457|NCT03129100|"~     The purpose of this study is to evaluate, in participants having achieved a state of~     sustained remission, if the ixekizumab treatment groups are superior to the placebo group in~     maintaining response during the randomized withdrawal-retreatment period in participants with~     axial spondyloarthritis.~   "
33458|NCT03129087|"~     This study will compare the effects of vocal rest versus continuous vocalization for one hour~     immediately following botulinum toxin injections for adductor spasmodic dysphonia.~   "
33459|NCT03129074|"~     The purpose of the study is to assess the efficacy of varlitinib in combination with~     capecitabine as measured by objective response rate (ORR) assessed by independent central~     review (ICR), based on RECIST v1.1 criteria.~   "
33460|NCT03129061|"~     This is a single-center cross-sectional imaging and correlative biomarker study in patients~     with Squamous Cell Carcinoma of the Head and Neck (SCCHN). Cohort 1 will be patients with~     unresectable or metastatic SCCHN cancer receiving standard of care (SOC) anti-PD-1 treatment~     and Cohort 2 will be neoadjuvant study participants who will receive one dose of anti-PD-1~     treatment prior to tumor resection or radiation. Blood sampling and tissue biopsies will be~     collected from both cohorts and both cohorts will undergo two whole body PET(Positron~     Emission Tomography)/CT(Computed Tomography) imaging with [18F]F-AraG. First scan prior to~     initiating anti-PD-1 treatment and second scan post initiation of anti-PD-1 treatment in~     Cohort 1 and prior to tumor resection or radiation in Cohort 2~   "
33461|NCT03129048|"~     The deleterious effects of obesity on cardiovascular disease (CVD) and metabolic risk factors~     (dyslipidemia, hypertension, and insulin resistance) are well-documented. Recent evidence~     also links obesity to cognitive decline and dementia. Dietary patterns are central to the~     development and maintenance of obesity and certain dietary patterns may contribute to the~     onset and progression of cognitive decline. With the rapid aging of the US population and the~     high prevalence of obesity among older adults, innovative lifestyle strategies to prevent~     cognitive decline among ethnically diverse obese older adults are critically needed.~   "
33462|NCT03129035|"~     All women with placenta accreta will be managed by upper segment cesarean section followed by~     cesarean hysterectomy without attempts of placental removal.~      Women were randomized to either bilateral internal iliac artery ligation before hysterectomy~     and after fetal extraction or no additional intervention~   "
33463|NCT03129022|"~     Women requesting epidural analgesia will receive a bolus of intravenous infusion of lactated~     Ringer's solution before initiation of the procedure. An 18-gauge Tuohy needle and closed-tip~     clear catheter with three lateral orifices (Portex, Smith Medical, Hythe, UK) were used in~     the sitting or lateral position, with a loss-of-resistance to air technique. Epidural~     catheters will be inserted 5-6 cm inside the epidural space. A test dose of 2 ml of lidocaine~     2% iss initiated followed by a loading dose of 10 ml of bupivacaine 0.25%. Analgesia is~     established and maintained throughout labor and delivery using 0.125% bupivacaine with~     fentanyl 2 μg/ml with patient-controlled epidural analgesia by means of a continuous epidural~     infusion (8 ml/h basal rate) and patient-controlled boluses (3 ml each) with 20-minlock-out~     intervals, continued at the same bolus dose until delivery.~      Pain was evaluated using a 0-10 cm visual analogue scale (VAS) before, 15 and 30 min after~     the loading dose followed by hourly assessment until delivery. VAS score assessment was based~     specifically on abdominal or back pain resulting from contractions~   "
33490|NCT03128593|"~     The purpose of this study in patients with mucopolysaccharidosis type II (MPS II) is below,~        -  to collect the safety information of JR-141~        -  to evaluate the plasma pharmacokinetics of JR-141~        -  to explore the efficacy of JR-141 on MPS II-related central nervous system symptoms and~          general symptoms~   "
33491|NCT03128580|"~     The purpose of this study is to compare the number of euploid embryos obtained per metaphase~     II oocyte in unstimulated (modified natural cycles) and stimulated IVF cycles.~   "
33568|NCT03127579|"~     The goal of this study is to test whether a longer meal duration could improve the diet~     quality of children. To answer this question we want to take an experimental approach by~     implementing a longer family meal duration to examine differences in children's eating~     behavior. The family dinner within a laboratory setting will be video taped and the main~     outcome is children's fruit and vegetables consumption.~   "
33464|NCT03129009|"~     Spontaneous non-traumatic intracerebral hemorrhage (ICH) is a common symptom in clinical~     practice and is the most serious among all types of stroke.Recently, as a relatively~     mainstream and recognized INTERACT2 (five well-known international studies in the~     cerebrovascular field: IMS-III, MR RESCUE, SYNTHESIS EXPANSION, INTERACT2, CHANCE) studies~     have shown that in patients with standard systolic blood pressure Early intensive~     antihypertensive therapy does not increase the incidence of death or serious adverse events.~     The above studies confirm the safety and efficacy of early potent depression.In 2017,~     Anesthesiology published a META analysis of intraoperative hypotension and blood pressure~     versus baseline fluctuations. The final outcome showed that 20% of blood pressure in the~     study was similar to MAP <65 mmHg, regardless of the duration of the duration There will be~     postoperative myocardial and renal damage. Ischemia is a very important cause of organ~     damage. Myocardial injury is closely related to the level of mean arterial pressure, while~     ischemia and ischemic reperfusion injury are closely related to postoperative acute renal~     injury.There is no targeted guideline for ICH perioperative blood pressure management,~     especially intraoperative blood pressure management, and no previous studies have studied~     most of the studies involving ICH patients with conservative treatment, ICH patients with~     surgical treatment There are few reports on blood pressure control during surgery.~   "
33465|NCT03128996|"~     This study is designed to estimate the efficacy and toxicity of familial HLA mismatched bone~     marrow transplants in patients with non-malignant disease who are less than 21 years of age~     and could benefit from the procedure.~   "
33466|NCT03128983|"~     Research results suggest changes of physiological parameters such as heart rate, respiration,~     skin conductance response, sleep duration, sleep quality and skin perfusion during the~     menstrual cycle. Latest fitness trackers allow to conveniently and non-invasively record~     these parameters. The present study aims to evaluate whether there is a correlation between~     physiological parameters and the menstrual cycle i.e. ovulation as measured by a urine~     ovulation test and the onset of menses. To collect data women will wear two smartwatches and~     a smartshirt at night. All three devices are CE-approved for sports and fitness.~   "
33467|NCT03128970|"~     The aim of the present study is to determine if implantation rate could be increased in women~     undergoing frozen embryo transfer cycles in case of adjusting their embryo development at~     hatching stage.~   "
33468|NCT03128957|"~     Controversy surrounds the use of regional cerebral oximetry (rSO2) as a measure of true~     cerebral oxygenation because of extracranial signal contamination and unmeasured confounding~     of cerebral a:v ratio. The measurement of brain tissue oxygen (PbrO2) has been used in~     routine neurosurgery and has been shown to reliably demonstrate cerebral hypoxia following~     severe head injury. It is the most direct measure of cerebral oxygenation. Here, we test the~     hypothesis that there is a correlation between PbrO2 and rSO2 under conditions of varying~     inspired oxygen fraction and the varying partial pressure of carbon dioxide in arterial blood~     in uninjured, normal human brain.~      Patients who are scheduled for elective removal of secondary cerebral metastases under~     general anesthesia will be recruited following written informed consent obtained by a study~     team member during their preoperative evaluation. BIS and rSO2 optodes will be applied,~     before induction of anesthesia, by a single researcher on both sides of the patient's~     forehead, as recommended by the manufacturer. General anesthesia will be maintained by total~     intravenous anesthesia (TIVA) with a combination of propofol (80-150 mcg/kg/min) and~     remifentanil (0.05-0.1 mcg/kg/min) targeted to a Bispectral Index range 40-60 (BIS; Covidien,~     Boulder, CO). Following craniotomy, the LICOX probe will be placed under direct vision into~     an area of normal brain within the tumor excision canal by the attending neurosurgeon. During~     a pause in surgery FIO2 and minute ventilation will be sequentially adjusted to achieve the~     following pairs of ventilation set points: 1) FIO2 0.3 and paCO2 30mmHg, 2) FIO2 1.0 and~     paCO2 40mmHg. After ≥5 minutes at each set point FIO2, PaCO2, rSO2 and PbrO2 will be recorded~     as a snap-shot.~      A sample size of 15 achieves an 80% power with a one-sided type I error of 5% to detect a~     positive correlation of 0.6 (from the null hypothesis of no correlation) between changes in~     PbrO2 and changes in rSO2 subsequent on alterations made in ventilation strategy. Correlation~     will be measured using Pearson's Correlation. P values < 0.05 will be considered~     statistically significant.~   "
33469|NCT03128944|"~     The investigators are developing Blood Pressure Imager (BPI), which is a new technology that~     does not require cuffs or expensive equipment, and can be used by untrained individuals in~     underserved, low-resource environments at their own homes or regional care settings. Over the~     last one-year the investigators have developed the BPI prototype, which is ready for testing.~     BPI is a wrist device that includes a camera, LED lights and soft membrane with a reflective~     coating. In this device feasibility study, the BPI will be placed over the radial artery at~     the wrist with the help of a wrist strap. The primary purpose of this feasibility study is to~     compare the BPI with a commercially available cuff-based blood pressure measuring devices.~   "
33470|NCT03128918|"~     The purpose of this study is is to use non-invasive diagnostic tests, Fibroscan and a simple~     blood test, to diagnose NASH in patients who undergo liver transplantation. Liver~     transplantation is a life-saving procedure for people with cirrhosis. Fatty liver is a common~     reason for liver transplantation due to obesity and diabetes. Fatty liver can happen again to~     the new transplanted liver and it is often due to metabolic risk factors (including diabetes,~     rapid weight gain, and immunosuppressive therapy, which are used to avoid rejection of the~     new liver). Some patients with fatty liver after liver transplant have non-alcoholic~     steatohepatitis (NASH) injury to liver the tissue (inflammation) and damage which is caused~     by a build-up of fat in the liver. This is a serious problem and can lead to cirrhosis and~     loss of the transplanted liver. There has been no detailed study into the recurrence of NASH.~     One reason for this is one of the only ways to detect fatty liver and NASH is to have a liver~     biopsy, which can be painful and have complications. Recently, a new technology (Fibroscan)~     and a simple blood test (cytokeratin 18) have been developed which can tell doctors how much~     a liver is damaged and how much fat it contains without pain or complications. This is a year~     long study involving one screening visit and 3 study visits, 3 months apart.~   "
33492|NCT03128567|"~     Deep brain stimulation of the sub thalamic nucleus (STN-DBS) is an efficient treatment to~     improve motor and non motor signs of Parkinson's disease (PD). In people aged more 70 years,~     an increased rate of side effects such as post-operative cognitive decline and/or postural~     instability with falls has been suspected with less improvement in the quality of life. Here,~     Investigators aim further explore the effects of STN-DBS in 50 patients with PD people aged~     more 69 years in a randomized parallel controlled study.~   "
33590|NCT03127228|"~     The purpose of the study is to evaluate if using Erbium-doped yttrium aluminium garnet laser,~     Erbium YAG laser (Er:YAG) laser could have adjunctive benefits to the conventional standard~     mechanical debridement to ablate the infected tissue around the dental implant and detoxify~     the contaminated implant surface for resolving peri-implant infection and enhance bone~     regeneration of peri-implant defects.~   "
33471|NCT03128905|"~     Chondrocalcinosis, recently renamed the calcium pyrophosphate deposition (CPPD) disease, is a~     very frequent affection of the elderly and causes very painful arthritis.~      International recommendations for the treatment of patients suffering from CPPD are based~     upon rare studies, not randomized, with small samples, and thus very weak scientific~     evidence.~      The treatment of CPPD arthritis is extrapolated from the experience of gout treatment,~     another crystal deposition disease.~      Among recommended treatments, colchicine and oral steroids are recommended as first-line~     treatments, while NSAIDs are used with caution in elderly populations of patients.~      Colchicine utilization is not risk-free, in particular with old patients and patients with~     renal impairment.~      Drug interactions of colchicine can have serious consequences, especially in a polymedicated~     old patient's population.~      Oral steroids are an interesting alternative in this indication with a potential of being~     better tolerated, but comparative efficacy with colchicine needs to be studied.~      From a broader point of view, colchicine and oral steroids have never been compared in any~     crystal related arthritis.~      This is the first large randomized controlled trial for CPPD acute arthritis.~   "
33472|NCT03128879|"~     The goal of this clinical research study is to learn if giving the drug venetoclax with~     ibrutinib can help to control the disease in patients with chronic lymphocytic leukemia (CLL)~     or small lymphocytic lymphoma (SLL). The safety of this combination treatment will also be~     studied.~      This is an investigational study. Ibrutinib is FDA approved and commercially available for~     the treatment of CLL/SLL. Venetoclax is FDA approved for some patients with CLL whose disease~     has come back after 1 or more previous treatments. The use of venetoclax in combination with~     ibrutinib is considered investigational.~      The study doctor can describe how the study drugs are designed to work.~      Up to 45 participants will be enrolled in this study. All will take part at MD Anderson.~   "
33473|NCT03128866|"~     The goal of this clinical research study is to determine if tranexamic acid can help in~     reduction of blood and blood product loss before, during, and after surgery.~   "
33474|NCT03128814|"~     Humans generally develop a preferred upper and lower extremity. Due to repetitive uneven~     loading, this gradually results in structural (e.g. increased bone and muscle mass) and~     functional (e.g. increased strength) adaptations to the dominant side of the body. The~     corresponding structural and functional asymmetry can be further accentuated by (intensively)~     practicing a unilateral sport such as tennis, which is very popular. Yet, research on this~     particular topic is scarce, especially in (pre)adolescent players. Existing studies, which~     often face methodological shortcomings (e.g. crosssectional designs, small sample sizes, no~     link to field methods), mainly focus on adults and structural asymmetry of the upper~     extremity itself, with very little or no attention to whole body structural as well as~     functional asymmetry. Moreover, the link of both forms of asymmetry with growth and~     maturation, everyday locomotion, technical skill performance and whole body injury is~     currently not (fully) understood. Therefore, the main purpose of this research project is to~     gain comprehensive knowledge on the degree, development and implications of both structural~     and functional asymmetry during a critical period in life using a longitudinal approach. As~     such, this project among youth elite tennis players will provide insights on the extent to~     which structural and/or functional asymmetry is acceptable for being most successful but~     remaining injury free.~   "
33475|NCT03128801|"~     Background: Low back pain is a major problem for public health that affects about 60-85% of~     the population at some point in life. Approximately 10-40% of individuals with low back pain~     develop the chronic form. International guidelines consider three groups of treatment options~     for low back pain: medication, invasive and conservative treatments in which conservative~     approach is the most recommended. The European Guidelines for Management of Chronic~     Non-specific Low Back Pain recommends that supervised exercise programs should be used as~     front-line treatment for chronic low back pain, such as stabilization exercises, conventional~     stretching and other active exercise, but there is no consensus on literature on the most~     effective form of treatment. However, there is limited evidence about the effects of a global~     stretching intervention using self-stretching postures for chronic low back pain.~      Objectives: The aim of this research is to compare the effects of an active global stretching~     program (GSP) using self-management of posture versus stabilization exercises versus a mixed~     program (GSP and stabilization exercises) on pain intensity and disability for patients with~     chronic non-specific low back pain.~      Methods: This study is a randomized controlled three arm clinical trial with examiner~     blinding. A sample of 129 patients with chronic non-specific low back pain will be randomly~     assigned to three treatment groups (GSP, Stabilization Exercises and Mixed group). The~     eligibility criteria will be 18 and 50 years, pain in the last three months and/or pain in at~     least half of the days in the past six months, pain located between T12 and the gluteal~     folds, pain intensity greater than or equal to three, and score greater than 14% on Oswestry~     Disability Index. Patients will be assessed in baseline, immediately after treatment and~     after one and three-months follow-up. Sessions will be provided weekly for eight weeks by a~     single therapist lasting 40 minutes. The primary outcomes will be pain intensity and low back~     pain related disability and the secondary outcomes will be fear avoidance, global perceived~     effect of treatment and muscle flexibility. All statistical analysis will be conducted~     following principles of intention to treat, and the treatment effects will be calculated~     using linear mixed models.~   "
33476|NCT03128788|"~     It is reported that the distribution of contrast medium had an obvious correlation with the~     extent of sensory analgesia after injection of LA. Our previous study showed that different~     posture (prone vs. lateral decubitus) resulted in different degree of contrast medium spread.~     We supposed that differences of epidural pressure between diverse postures might be one~     factor contributing those differences of epidurography.~      This study was designed to compare the epidural pressure and extent of spread of~     epidurography between prone and lateral decubitus position~   "
33477|NCT03128775|"~     The objective of the present study is to estimate the effect of nudging proposals on the~     students' Body Mass Index, based on changes made in the school environment. This is a~     factorial randomized community trial, which will be conducted in 18 public schools in the~     city of Duque de Caxias, RJ.~   "
33478|NCT03128762|"~     The primary objective of this study is to demonstrate differences in ILC2 blood levels~     between asthma patients and control patients.~   "
33505|NCT03128398|"~     This is an Expanded Access to Investigational Drug program available through the FDA. Some~     specific conditions to qualify for this program includes gastroesophageal reflux disease with~     upper GI symptoms, gastroparesis, and chronic constipation. Patients failing standard~     therapies for these conditions may be eligible to receive domperidone. This program~     facilitates availability of investigational drugs, (such as domperidone) to patients with~     serious diseases or conditions when there is no comparable or satisfactory alternative~     therapy to diagnose, monitor or treat the patients's disease or condition. Authorization must~     be obtained from FDA prior to the importation, interstate shipment and administration of~     domperidone.~   "
33608|NCT03126981|"~     The goal of this clinical trial is to evaluate the effects of consuming 1.5 oz almonds twice~     daily on insulin sensitivity and markers of cardiometabolic health in men and women with~     prediabetes.~   "
33479|NCT03128749|"~     Obsessive-Compulsive Disorder (OCD) patients have a response rate of 50-60% to exposure and~     response prevention (ERP) therapy and SSRI antidepressants. Mindfulness-Based Cognitive~     Therapy (MBCT) consists of training the participant to non-react to negative thoughts and~     emotions. Applying MBCT to OCD patients may help them behave with equanimity in response to~     their obsessions, and therefore acknowledge them with the same attention and intention as~     they admit any other disturbing thought without reacting to it. MBCT has demonstrated~     effectiveness in major depression, but much less attention has been given to MBCT in OCD. ERP~     and MBCT, although sharing aspects like exposure, are based on different theoretic and~     therapeutic factors. EPR is based on a direct anxiety habituation process whereas MBCT trains~     a holistic manner of becoming familiarized with distressful thoughts and emotions while~     learning to develop a new relationship to them. Thus, MBCT may decrease anxiety indirectly~     through a major attention awareness and non-reactivity to thoughts and emotions.~      OCD is characterized by altered cortical-striatal-thalamic-cortical (CSTC) circuit and~     default mode network (DMN) connectivity when performing different tasks and during the~     resting state. It has been establish that the ventral CSTC circuit is mostly associated with~     emotional processing, while the dorsolateral aspect of the CSTC circuit is preferentially~     involved in cognitive processing. In this regard, we hypothesized that clinical amelioration~     will be accompanied by a re-establishment of functional connectivity within dorsolateral and~     DMN circuits, which will in turn be associated with improvement of certain neuropsychological~     processes. CSTC and DMN circuits have also shown to be sensitive to prolonged stress~     situations. Specifically, childhood trauma has been related to larger brain volumes and it~     has been associated with different OCD clinical subtypes.~      Aims: 1. To assess MBCT effectiveness in treatment non-naive OCD patients. 2. To study~     cognitive and neuropsychological characteristics that mediate or moderate MBCT response. 3.~     To examine the changes in cognitive, neuropsychological and neuroimaging patterns associated~     with an MBCT intervention. 4. To identify a brain biomarker for positive response to MBCT in~     non-naïve OCD patients. 5. To study cognitive, neuropsychological and early stress expousure~     mediators or moderators of functional changes in CSTC and DMN patterns in response to MBCT.~   "
33480|NCT03128736|"~     Rapid onset of proton-pump inhibitors to achieve a fast symptom is an unmet need in treating~     gastroesophageal reflux disease (GERD) but there was no report on the short-term clinical~     effects and timing to symptom relief comparing dexlansoprazole 60 mg to esomeprazole 40 mg.~     This pilot study aims to compare the one-week clinical effects of single doses of the two~     drugs in treating GERD patients.~   "
33481|NCT03128723|"~     The study will look to evaluate the tolerance of a light therapy-based acne mask device in~     participants who report having sensitive skin. All participants will receive a cleanser, a~     light therapy mask, and an extra activator for the light therapy mask.~   "
33482|NCT03128710|"~     There have been calls from patients, payers, healthcare providers, and policy makers for an~     evaluation of newer, high-cost radiation technologies compared to conventional forms of~     radiation therapy. National attention has focused on the use of intensity modulated radiation~     therapy (IMRT) into routine daily clinical practice for prostate cancer. The goal of the~     present study is to determine whether the type of radiation treatment received by the~     patients can result in a reduction in patient-relevant side effects following prostate~     irradiation. The analysis will be performed by obtaining patient answered surveys looking at~     side effects.~   "
33483|NCT03128697|"~     The global research project was organized as a clinical process starting with an evaluation~     aiming at the determination of a diagnosis pertaining to the degree of satiety signal~     capacity. It was extended by a phase of metabolic and behavioural characterization to better~     understand the clinical condition of the patients. The main part of the program was a weight~     loss intervention that was focused on high satiating foods. Finally, the process was~     completed by an evaluation allowing to determine the impact of the intervention on the~     metabolic and behavioural conditions of the patients.~   "
33484|NCT03128684|"~     The Lentil Satiety study will examine the effects of replacing wheat, rice, and potato with~     two types of lentils within food products (muffins, chilies, and soups) on satiety and food~     intake in healthy adults.~   "
33485|NCT03128671|"~     This randomized clinical trial tests a cognitive reorientation intervention to prevent~     delirium in the intensive care unit using scripted audio messages, recorded by the patient's~     family and played at hourly intervals during daytime hours, to provide information about the~     ICU environment to the patient (the Family Automated Voice Reorientation intervention,~     FAVoR). The investigators hypothesize that providing ongoing orientation to the ICU~     environment through recorded audio messages in a voice familiar to the patient will enable~     the patient to more accurately interpret the environment and reduce risk of delirium.~     Increasing awareness of daytime by cuing patients during waking hours may also improve~     day/night orientation, nighttime sleep/rest, and further reduce risk of delirium.~   "
33486|NCT03128658|"~     While a number of factors are known to be associated with the development of trauma induced~     coagulopathy (TIC), inflammation, and multi-organ failure, we currently cannot predict which~     patients are at risk for developing these life threatening conditions with any certainty. In~     this prospective observational study, we will investigate the many factors that contribute to~     the development of trauma induced coagulopathy, post injury inflammation and the development~     of organ dysfunction in order to develop a multi scale computational algorithm of clinical~     prediction. Using a convenience sample technique, demographic data, physiologic data, blood~     samples and clinical variables will be collected over 5 days following traumatic injury. A~     computational model will be used to predict the development of TIC and multi-organ failure.~   "
33487|NCT03128645|"~     In patients with central obesity, the effect of the abdominal corset on colonoscopy~     completeness, cecum and ileum intubation time will be investigated.~   "
33488|NCT03128619|"~     This phase I/II trial studies side effects and best dose of copanlisib when given together~     with letrozole and palbociclib and to see how well they work in treating hormone receptor~     positive HER2 negative stage I-IV breast cancer. Copanlisib and palbociclib may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs, such as~     letrozole, may lessen the amount of estrogen made by the body. Giving copanlisib, letrozole,~     and palbociclib may work better in treating patients with breast cancer.~   "
33489|NCT03128606|"~     The study is a First-in-Human, Phase I, randomized, double-blind, placebo-controlled, single~     center study, evaluating single and multiple ascending oral doses of GLPG3067 and the~     combination of GLPG3067 and GLPG2222 and the combination of GLPG3067,GLPG2222 and GLPG2737~     given for 14 days in healthy women of non-childbearing potential.~      The purpose of the study is to evaluate the safety and tolerability of single ascending oral~     doses and multiple ascending oral doses of GLPG3067 given to healthy women of~     non-childbearing potential compared to placebo, as well as of multiple oral doses of the~     combination of GLPG3067/GLPG2222 compared to matching placebo for each compound and multiple~     oral doses of the combination of GLPG3067/GLPG2222/GLPG2737 compared to matching placebo for~     each compound.~   "
33520|NCT03128203|"~     To investigate whether 40 IU of intranasal oxytocin treatment can influence the resting-state~     functional connectivity in healthy males.~   "
33493|NCT03128554|"~     Traditional models of smoking cessation focus on delivering advice and counseling to quit and~     providing assistance to patients ready to quit smoking, but do not actively intervene with~     patients who are not ready to quit (NRTQ). This abrupt cessation approach is often not an~     appealing option to those not ready to quit, however, a reduction approach can seem more~     attainable and engaging. In response to this need, this smoking cessation intervention has~     been developed.~      This research is part of a pilot study to assess the feasibility of introducing a NRTQ~     intervention in a primary care setting. This study will also assess the effectiveness of~     increasing the number of smoking reduction interventions delivered, provider confidence and~     satisfaction, relative to control practice. Outcomes will be assessed by a pre-survey and a~     three-month follow-up survey, administered to all study participants. All study participants~     will also be asked to fill out brief NRTQ consult forms for each NRTQ patient they encounter~     for a two-week period. Additionally, participants randomized to the intervention arm will~     receive training, and access to tools and resources.~   "
33494|NCT03128541|"~     The study aims to ascertain whether being placed in a sitting or lateral decubitus position,~     influences identification of the midpoint of the L4/L5 intervertebral space, using manual~     demarcation of Tuffier's line. Participants will be randomly assigned to a sitting or lateral~     decubitus position. The mid-point of the L4/L5 intervertebral space will be identified using~     anatomical palpation and compared to the true mid-point measured by ultrasound. The~     procedure will be repeated in both positions on the same participant.The study will be a~     prospective, randomized, double blinded, crossover trial~   "
33495|NCT03128528|"~     The hypothesis is that the SGLT-2 inhibitor empagliflozin reduces tissue sodium content in~     patients with chronic heart failure, and if the hypothesis is proven, that this mechanism~     contributes to the beneficial effects found in EMPA-REG Outcome trial potentially via~     exerting beneficial effects on the vascular structure and function of the micro- and~     macrocirculation.~   "
33496|NCT03128515|"~     The Novel use Of Hydroxyurea in an African Region with Malaria (NOHARM) study is the first~     placebo-controlled randomized clinical trial of hydroxyurea treatment in a malaria endemic~     region. NOHARM has now achieved full enrollment; all children have completed the blinded~     portion of the protocol and are in the open-label study treatment portion.~      This extension study of maximum tolerated dose (MTD), addresses the next critical set of~     questions about the optimal dosing and monitoring of hydroxyurea treatment for children with~     SCA in low-resource settings. By providing guidance about optimal hydroxyurea treatment, the~     NOHARM MTD Study will directly inform policies that can transform the health of African~     children living with SCA.~   "
33497|NCT03128502|"~     Subjects were selected from the outpatient clinic, Department of Oral Medicine and~     Periodontology, Faculty of Oral and Dental Medicine, Cairo University. Ten healthy control~     subjects presented with clinically healthy periodontium. Ten patients who had plaque induced~     gingivitis. Ten patients who had generalized chronic periodontitis. Ten patients who had~     generalised aggressive periodontitis. Pentraxin-3 levels were evaluated in GCF and saliva of~     all subjects included in this study with ELISA technique.~   "
33498|NCT03128489|"~     The purpose of this study is to assess the immunogenicity and safety of DTPa-IPV/Hib when~     administered at 6, 10 and 14 weeks to healthy Indian infants, as per guidance from the Indian~     regulatory authority. The 6, 10 and 14 week schedule reflects the current Indian standard of~     care.~   "
33499|NCT03128476|"~     In Southeast Asia, Essence of Chicken, a chicken-meat-extract, is a popular beverage and is~     consumed as a traditional remedy for several ailments, including the use as a nutritional~     supplement for sickness, enhancement of mental efficiency, and recovery from mental fatigue.~     While the elderly use it as a nutritional supplement, students use it for relief from anxiety~     during exam times.~      The present study is conducted in order to assess the effects of BEC on various physical and~     mental parameters including physical fatigue, working memory and attention, mood and stress,~     in comparison to placebo.~   "
33500|NCT03128463|"~     Macular neovascular diseases including age-related macular degeneration (AMD), polypoidal~     choroidal vasculopathy (PCV), pathological myopia (PM) and etc. can cause severe vision loss.~     It has become the focus of World Health Organization's blindness- prevention cause. A new~     anti—VEGF drug conbercept has been approved and showed good efficacy and safety in clinical~     trials. But the exact therapeutic regimen and the efficacy in the real world still needs to~     be further studied, the reasons are as follows:~        1. The efficacy and safety data of conbercept are collected from rigorous random controlled~          trials (RCT) , it can not fully reflect the clinical application of conbercept in the~          real world . Therefore, the knowledge of the therapeutic regimen, safety and efficacy of~          conbercept is still limited.~        2. Conbercept has been approved for wet-AMD only, but in clinical practice, some doctors~          applied other off-label use of conbercept. These off-label use has become a common~          phenomenon all over the world for the instruction book of drugs usually lag behind~          scientific researches. There is no specific law or regulatory document of drug off-label~          use in China until now.~        3. Anti-VEGF drugs are expensive and often require multiple treatments, and some patients~          have poor or even no response to the drugs. This resulted enormous waste of medical~          resources. So, how to accurately find out those patients who have good response, how to~          develop individualized therapeutic regimen, and the response of patients in the real~          world need to be urgently investigated in the aspect of pharmacogenomics, and~          pharmacometabolomics.~      Therefore, the investigators plan to carry out real-world researches of conbercept on~     treating macular neovascular diseases has significance and urgency.~      The investigators intended to conduct a nationwide, non-intrusive, prospective,~     observational, and multicenter registration study to investigate the efficacy of conbercept~     in the real-world. And this study will explore the pharmacogenomics and pharmacometabolomics~     of conbercept, relationships of phenotype and the effectiveness of the drug, optimize the~     therapeutic regimen, then reduce the financial burden of patients and save the limited~     medical resources to achieve the purpose of accurate treatment.~      For three unanswered questions raised in the background, the researchers carried out the~     following purposes:~        1. Investigate the safety and efficacy of conbercept in treating neovascular macular~          disease in the real world.~        2. Find out whether the off-label use of conbercept on PCV and PM have good efficacy.~        3. Explore the pharmacogenomics and pharmacometabolomics of conbercept through large-sample~          registration study.~   "
33501|NCT03128450|"~     This Pilot study will evaluate the safety and Efficacy of an investigational cell~     transplantation therapy, h-NSC, in patients with Parkinson's disease, through nasal drug~     delivery, a new delivery way. All patients will receive the therapy, which consists of human~     neural stem cells,~   "
33502|NCT03128437|"~     This is a randomized control trial to test the effect of an anxiety sensitivity intervention~     on health behaviors among 18-35 year-olds.~   "
33503|NCT03128424|"~     The primary objective of the feasibility study is to evaluate the safety and effectiveness of~     the PQ Bypass Stent Graft System in the treatment of atherosclerotic lesions of the native~     superficial femoral artery (SFA) or the superficial femoral and proximal popliteal arteries.~   "
33504|NCT03128411|"~     Phase 2, single-arm, open-label trial. Patients will receive bosutinib for the duration of~     the study.~   "
33565|NCT03127618|"~     Information relating to requesting compassionate access for this investigational drug can be~     found at the following link:~      http://www.pfizer.com/research/compassionate_use~   "
33506|NCT03128385|"~     This 3-year research project aims to investigate and compare the treatment effectiveness (in~     terms of motor and psychosocial outcomes) and potential predictors (in terms of~     demographical, biological and psychosocial domains) of the intensive and distributed Child-~     and Family-Friendly CIT protocols with an equivalent intervention period in children with CP~     by cross-over study design. In addition, the selection and examination of outcome measures~     were based on the ICF-CY model to provide comprehensively documents.~   "
33507|NCT03128372|"~     The primary objective of the study is to validate that the production equivalent PM7100~     System in conjunction with Adult Sensors (PMSENS71-A) meet product requirements for cerebral~     accuracy, cerebral trending accuracy, and somatic trending.~   "
33508|NCT03128359|"~     This pilot phase II trial studies how well high dose cyclophosphamide, tacrolimus, and~     mycophenolate mofetil work in preventing graft versus host disease in patients with~     hematological malignancies undergoing myeloablative or reduced intensity donor stem cell~     transplant. Sometimes the transplanted cells from a donor can make an immune response against~     the body's normal cells (called graft versus host disease). Giving high dose~     cyclophosphamide, tacrolimus, and mycophenolate mofetil after the transplant may stop this~     from happening.~   "
33509|NCT03128346|"~     The TTP block is a novel regional anesthetic technique that shows promise in providing~     analgesia for anterior chest wall incisions and median sternotomy. The investigators hope to~     show that by providing the TTP block, there will be reduced early postoperative pain, reduced~     sedation and shallow breathing, reduced time on breathing machine, leading to an increase in~     patient comfort and satisfaction. The investigators also hope the decreased need for pain~     medication and reduced time on the breathing machine will translate into decreased nursing~     workload.~   "
33510|NCT03128333|"~     The aim of this study is to examine whether self-monitoring PA with the RunKeeper app with~     additional physiotherapy coaching is superior in improving patients' self-reported~     leisure-time PA compared with usual care in cancer patients after 12 weeks.~      This is a single-center, prospective, two-armed, randomized controlled trial. Adult cancer~     patients and cancer survivors are randomized in one of the two study arms, (Group A)~     RunKeeper app + physiotherapy coaching or (Group B) usual care.~      Patients assigned to the intervention group will be instructed to use the RunKeeper app for~     12 weeks to self-monitor leisure-time PA. In addition, patients will be educated about the~     health risks of a sedentary lifestyle, inactivity and (when applicable) other unhealthy~     lifestyle behaviors (e.g. unhealthy diet, overweight or obesity, sun exposure, alcohol~     intake). Benefits of a behavior change, becoming physically active and pursuing a healthy~     lifestyle will be explained by a trained physiotherapist who will also coach the patient~     during the PA program. The biweekly physiotherapy coaching starts at baseline and will follow~     a structured sequence of strategies to change patients PA behavior which will contribute to~     the adoption of leisure-time PA in patients daily living, so the program will be optimally~     tailored to the patients capabilities and preferences.~      The primary endpoint is to examine the effectiveness of the RunKeeper use with additional~     physiotherapy coaching in improving patients' leisure-time PA compared with usual care in~     cancer patients as measured by the PASE subscale leisure-time Sum Score at baseline, 6, 12~     and 26 weeks.~   "
33511|NCT03128320|"~     The purpose of the study is to analyse skin blood flow in diabetic patients with peripheral~     artery disease. The patients receive a single dose of placebo, 1 mg BAY1193397, and 5 mg~     BAY1193397. The analysis of safety and tolerability are secondary objectives of this study.~   "
33512|NCT03128307|"~     Online patient registration to participate in clinical trial to test OTC mouthpiece that~     controls position of the tongue to reduce snoring.~   "
33513|NCT03128294|"~     In this study the investigators would like to explore the patient and tumour characteristics~     of long-term survivors of ovarian cancer (>10 years). Indentifiying the characteristics of~     long-term survivors not only helps find prognostic factors for survival but may aid in~     generating hypotheses for novel therapeutic strategies.~   "
33514|NCT03128281|"~     The goal of this clinical research study is to compare the level of pain 2 hours after~     surgery in patients after the use of the AirSeal® Insufflation System (AIS) at a high or low~     pressure setting or the standard insufflator (the conventional insufflation system, or CIS).~     Insufflation is the creation of a pressure barrier of air/gas within the abdomen that~     allows the surgeon more space to work in.~   "
33515|NCT03128268|"~     This study aims to evaluate the effectiveness of 4D image acquisition and post-processing~     with Vios Works for the evaluation of 3D images acquired on GE Magnetic Resonance Imaging~     scanners. Specifically, the investigators propose to evaluate the following:~        1. Image acquisition time using traditional 2D and new 4D processing techniques;~        2. Image quality for 2D and 4D processing techniques subjectively~        3. Post-processing time for the two techniques.~        4. Correlation of overall Left ventricular and right ventricular volumes and functions and~          aortic and pulmonic flow studies using the two techniques.~        5. The study will monitor any changes in patient diagnoses or treatment resulting from any~          differences in interpretations between the two processes.~   "
33516|NCT03128255|"~     Regular thyroid diagnostics versus augmented thyroid work-up with additional I-124 PET/US~     fusion for metabolic-sonographic nodule allocation in patients with benign thyroid diseases~   "
33517|NCT03128242|"~     This study aims to investigate oxytocin's effect on attentional bias training. Healthy~     participants will undergo a dot-probe task-based training to direct their attention away from~     negative stimuli (as compared to neutral). Effects of the training will be assessed using an~     eye-tracking anti-saccade task.~   "
33518|NCT03128229|"~     The overarching goals of this study are to determine whether tubular dysfunction (elevated~     urine sodium, bicarbonate and amino acids) and injury (elevated kidney injury molecule 1~     [KIM-1], neutrophil gelatinase-associated lipocalin [NGAL] and matrix metallopeptidase 9~     [MMP9]) exist in new onset diabetic ketoacidosis (age 3-18), whether it is reversible and~     whether it is related to uricosuria and copeptin. The investigators propose to study a cohort~     of youth (ages 3-18, n=40) with new onset T1D who have serum and urine collection at DKA~     diagnosis and 3-month follow-up.~   "
33519|NCT03128216|"~     Propose to comparison effectiveness of blind local anesthetic infiltration with ultrasound~     guided Transversals Fascia Block and Spinal Anesthesia in patients undergoing to inguinal~     hernia repair surgery. The effectiveness is defined as pain control during intraoperative and~     time need to reach hospital discharge criteria in the post-operative period.~   "
33521|NCT03128190|"~     Background: Intraoperative fluid therapy guided by mechanical ventilation-induced~     pulse-pressure variation (PPV) may improve outcomes after major surgery. It was tested this~     hypothesis in a multi-center study.~      Methods: The patients were included in two periods: a first control period (control group;~     n=147) in which intraoperative fluids were given according to clinical judgment. After a~     training period, intraoperative fluid management was titrated to maintain PPV< 10% in 109~     surgical patients (PPV group). It was performed 1:1 propensity score matching to ensure the~     groups were comparable with regard to age, weight, duration of surgery, and type of~     operation. The primary endpoint was postoperative hospital length of stay.~   "
33522|NCT03128177|"~     The purpose of this study is to determine if high salt diet contributes to high nighttime~     blood pressure. The investigators will determine if high compared to low salt diet increases~     24-hour blood pressure levels. The investigators will also determine if high salt diet~     affects blood vessel stiffness, cardiac output, and sleep apnea. The study will also~     determine how high salt diet affects the activity of certain genes related to control of~     blood pressure. A total of 60 participants will be enrolled in the study.~   "
33523|NCT03128164|"~     This is a Phase 1, open-label study of HMPL-689 administered orally to patients with lymphoma~     for whom failed of standard care or have no standard of care.This study will consist of a~     dose escalation stage (Stage I) and a dose expansion stage (Stage II).~   "
33524|NCT03128151|"~     The NMB (Neuromuscular Blockade) is the most frequent complication in anesthesiology~     associated with an increase in adverse respiratory events in the postoperative period. Its~     appearance depends on multiple factors. The introduction of a comprehensive educational~     strategy aimed at promoting the proper management of NMB in the intraoperative period and a~     package of measures that must be performed (intraoperative neuromuscular monitoring and~     reversal of the effect of neuromuscular blockers) may contribute to a decrease in the~     incidence of NMB, Increase safety in the surgical patient and decrease associated costs.~   "
33525|NCT03128138|"~     1. To evaluate safety, tolerability and pharmacokinetics (PK) and pharmacodynamics (PD)~          characteristics of SPH3127 dose escalation, a single oral dose in Chines healthy~          volunteers.~        2. To explore the appropriate dose and provide the basis for the subsequent clinical~          trials.~   "
33526|NCT03128125|"~     The main objective of this study is to determine whether children with high intellectual~     potential have gestural and / or executive difficulties compared to control children.~   "
33527|NCT03128112|"~     This is a multi-site, cross-sectional study of 3-8 year old children and their parents~     presenting for a well-child check. The investigators are assessing whether a novel,~     educational, exam room poster can effectively prompt parents to ask their pediatricians about~     their children's weight status and improve parents' perceptions of their children's weight~     status.~   "
33528|NCT03128099|"~     Social impairments are core features of schizophrenia that lead to poor outcome. Social~     skills and competence improve quality of life and protect against stress-related exacerbation~     of symptoms, while supporting resilience, interpersonal interactions, and social affiliation.~     To improve outcome, we must remediate social deficits. Existing psychosocial interventions~     are moderately effective but the effort-intensive nature (high burden), low adherence, and~     weak transfer of skills to everyday life present significant hurdles toward recovery. Thus,~     there is a dire need to develop effective, engaging and low-burden social interventions for~     people with schizophrenia that will result in better compliance rates and functional outcome.~      The investigators will test the effectiveness of a novel adaptive virtual reality (VR)~     intervention in improving targeted social cognitive function (social attention, as indexed by~     eye scanning patterns) in individuals with schizophrenia. VR technology offers a flexible~     alternative to conventional therapies, with several advantages, including a simplified and~     low-stress social interaction environment with targeted opportunities to simulate, exercise~     and reinforce basic elements of social skills in a very wide range of realistic scenarios,~     and to repeat exposure to naturalistic situations from multiple angles.~   "
33529|NCT03128086|"~     After a period of mechanical ventilation, a spontaneous breathing trial is performed before~     extubation in order to assess the patient's ability to breathe. In neurological patients a~     spontaneous breathing trial can not predict the success of extubation. The extubation failure~     is associated with a longer intensive care unit stay and hospital stay, as well as more~     infections and higher mortality.~      The purpose of this study is to demonstrate that the use of a protocol-directed weaning in~     neurological patients reduces the rate of extubation failure and associated complications.~   "
33530|NCT03128073|"~     The study is a proof-of-concept, a feasibility study of peritoneal ultrafiltration with a~     wearable device, Carry Life System Ultrafiltration (CLS UF) and will be performed on 4-6~     stable peritoneal dialysis (PD) patients without clinical signs of dehydration. The study~     session starts with an initial fill of the abdomen, with a standard, glucose based PD~     solution. The CLS UF device is then connected to the patients existing, PD catheter. A~     Glucose-salt solution is added to 180 ml of the intraperitoneal fluid which is intermittently~     transferred from the peritoneal cavity through a closed system using the CLS UF cycler and~     then returned to the patient. The addition of the Glucose-salt solution maintains a stable~     intraperitoneal osmolarity and compensates for the glucose uptake and dilution which occurs~     in standard PD treatments.~   "
33531|NCT03128060|"~     This study will test the effectiveness of integrating an evidence-based model of home-based~     palliative (HBPC) within primary care clinics on patient and caregiver outcomes. The~     investigators will conduct a randomized controlled trial, randomizing 1,155 seriously ill~     patients (and approximately 884 family caregivers) who receive primary care from 10 regional~     accountable care organizations (ACOs) in California to one of two study groups: HBPC or~     enhanced usual care (EUC). Follow-up data will be collected via telephone surveys with~     patients at 1- and 2-months and with caregivers at 1- and 2-months, and, as appropriate,~     following the death of the patient.~   "
33532|NCT03128047|"~     The purpose of this study is to determine if the Optune NovoTTF-200A device can be safely~     used in pediatric patients with high-grade glioma, both alone and in combination with~     standard chemotherapy medications.~   "
33566|NCT03127605|"~     Information relating to requesting compassionate access for this investigational drug can be~     found at the following link:~      http://www.pfizer.com/research/compassionate_use~   "
33533|NCT03128034|"~     This phase I/II trial studies the side effects and best dose of 211^astatine(At)-BC8-B10~     before donor stem cell transplant in treating patients with high-risk acute myeloid leukemia,~     acute lymphoblastic leukemia, or myelodysplastic syndrome. Radioactive substances, such as~     astatine-211, linked to monoclonal antibodies, such as BC8, can bind to cancer cells and give~     off radiation which may help kill cancer cells and have less of an effect on healthy cells~     before donor stem cell transplant.~   "
33534|NCT03128021|"~     The Department of Psychiatry at the University of Pittsburgh is conducting a research study~     to learn about the changes that occur in the brain when individuals suffer from and then are~     treated for depression. The NEMO study has two main purposes. The first is to provide~     medication treatment to individuals ages 60 and older who are currently depressed.~      The second part of the study involves completing a series of 4 MRIs, which assess changes in~     brain function over the course of treatment. This research may help investigators to develop~     faster and more effective treatment plans in the future, as brain responses that are detected~     early in treatment may predict how well an individual will respond to antidepressant~     medication.~   "
33535|NCT03128008|"~     This is a prospective phase II study designed to evaluate an accelerated and adaptive RT~     approach for locally-advanced non-small cell lung cancer (NSCLC). All eligible subjects will~     have an interim PET-CT during radiation therapy to determine the metabolic complete response~     rate. Radiation therapy will be given in an accelerated fashion (2 Gy/fraction, 6~     fractions/week) with concurrent chemotherapy. Interim responses will be assessed using~     PERCIST criteria.~      Despite concurrent chemotherapy and radiation therapy, local/regional failure occurs in ~50%~     of patients with locally-advanced NSCLC. Clinical studies have demonstrated that accelerated~     fractionation (giving the same total dose in a shorter period of time) improves outcomes in~     several malignancies, including lung cancer. Administering higher than conventional doses of~     RT to all sites of original disease leads to inferior outcomes. Adapting the RT approach,~     giving a higher dose to slowly responding disease as assessed with interim PET has been shown~     to be feasible. PERCIST (Positron Emission Tomography Response Criteria in Solid Tumors)~     provides guidelines on how to report responses to therapy based on PET-CT. PET-CT response~     has been shown to be prognostic in a variety of clinical scenarios in lung cancer including~     after induction therapy. In one study, PET was performed after neoadjuvant chemoradiotherapy~     (40-50.4 Gy). Complete or partial metabolic response using PERCIST criteria was predictive of~     loco-regional, distant, and overall progression-free survival.~   "
33536|NCT03127995|"~     The standard treatment of localized breast cancers consists of surgical removal of the tumor~     at the breast or removal of the entire breast and lymph nodes (sentinel lymph node and / or~     axillary dissection) with or without chemotherapy followed by radiotherapy on the breast or~     thoracic wall and the lymph node areas from 5 to 6.5 weeks.~      Shorter radiotherapy treatments over 3 weeks for breast cancer without lymph node involvement~     have been equally effective and have no more side effects in several clinical trials~     involving several thousand patients. This called hypofractioned radiotherapy has become a~     standard for breast cancers in the absence of lymph node involvement in postmenopausal women.~      The objective of the HypoG01 trial is to evaluate hypofractioned radiotherapy in women who~     require radiotherapy in the breast or chest wall and lymph node areas by comparing standard~     over 5 to 6.5 weeks and hypofractionated irradiation over 3 weeks analyzing the possible side~     effects and in particular the risk of lymphedema (swelling of the arm on the side treated)~     and the effectiveness of these treatments~   "
33537|NCT03127982|"~     The present study aims at evaluating the effects of a CBT intervention, a cultural adaptation~     of the Unified Protocol for the Trans-diagnostic Treatment of Emotional Disorders (UP) in~     victims of the Colombian armed conflict.~      A randomized clinical trial aimed at evaluating the effects of the UP in a group of 100~     internally displaced victims of armed conflict living in Bogotá is being implemented.~     Participants are recruited from several governmental, non-governmental agencies as well as~     community organizations of victims. Participants are being randomly assigned to treatment~     condition (N=50) or to waiting-list control (N=50). Treatment consists in 12 biweekly~     sessions covering the 8 modules of the original UP. The effects of the UP is evaluated~     through Patient Health Questionnaire (PHQ) and several measures of co-morbid emotional~     disorders, Anxiety, Depression, PTSD as well as level of functioning and quality of life.~   "
33538|NCT03127969|"~     The objective of this study is to evaluate the efficacy of fluidotherapy primarily on~     function and quality of life, secondarily on pain, morning stiffness, grip strength, and~     disease activity in patients with rheumatoid hand.Ninety-three patients were enrolled in this~     prospective, single-blind, randomized, and controlled trial. Patients were randomized into 2~     groups. Group 1 (n=47) had fluidotherapy (5 times per week, for 3-week duration) and Group 2~     (n=46) was the control group. All patients received joint protection and exercise program.~     The primary outcome measures were Health Assessment Questionnaire (HAQ) and Duruöz Hand Index~     (DHI) and secondary outcome measures were pain and morning stiffness assessed using the~     Visual Analog Scale (VAS, 0-100 mm), the Grip Ability Test (GAT), Disease Activity Score-28~     (DAS-28), and grip strength. These assessments were performed at baseline, at week 3 and week~     12 after treatment.~   "
33539|NCT03127956|"~     The objectives of this study are to assess the long-term safety of Olumacostat Glasaretil~     gel, 5.0% in patients with acne vulgaris~   "
33540|NCT03127943|"~     Assess the clinical impact of Buffered 1% lidocaine with epinephrine as compared to the~     Non-buffered 1% lidocaine with epinephrine in dental and oral surgical procedures.~   "
33541|NCT03127930|"~     This study sought to improve medication management by caregivers of community dwelling~     patients with dementia or simple memory loss. This was done by testing a tailored~     intervention delivered both in-home and by telephone by either a social worker or nurse. The~     intervention was designed to decrease medication deficiencies and improve medication~     adherence by developing problem solving skills.~   "
33542|NCT03127917|"~     The objective of this project is to determine the importance of peripheral vascular function~     on gait performance in older adults.~   "
33543|NCT03127904|"~     The objective of this Bayesian Adaptive trial is to compare a control group versus a~     comprehensive ulcer healing protocol. The latter involves a combination of compressive~     therapy, miokinetic drainage and muscle strengthening for the entire lower extremity pump~     among patients with lower extremity venous ulcers. The investigators hypothesized that the~     combined therapy will have a higher closure rate as well as lower time to closure.~   "
33544|NCT03127891|"~     TITLE: EFFECT OF SHORT-TERM PRANAYAMA ON ANAESTHESIA MANAGEMENT IN PATIENTS UNDERGOING~     CARDIAC SURGERY~      Primary aim: To evaluate the effect of pre-operative short term pranayama yoga on~     stress-induced hemodynamic (HR, MAP) changes in patients scheduled for cardiac surgery.~      Secondary aims:~        1. To compare the effect of YOGA on preoperative anxiety.~        2. To compare the effect of Yoga on SPO2.~        3. To compare effect of Yoga on total consumption of propofol administered using Closed~          Loop Anaesthesia Delivery system(CLADS)~        4. To compare effect of Yoga on total consumption of fentanyl, and vecuronium~        5. To compare effect of Yoga on post-operative anxiety (after extubation in CTVS ward)~        6. To compare effect of Yoga on postoperative outcome in terms of duration of mechanical~          ventilation, duration of ICU stay, incidence of complications and post-op mortality~   "
33545|NCT03127878|"~     Background: Despite recent recommendations for the inclusion of upper-limb endurance training~     in exercise training programs (ET) for patients with COPD, the majority of theses programs~     are yet focused only in lower-limb endurance training. However, these patients may have a~     hindered performance during the execution of simple activities of daily living (ADL)~     involving the upper-limbs. Therefore, one doubt remains: is the addition of upper-limb~     endurance training necessary? Aims: To verify whether patients with COPD become more~     physically active in daily life, as well as whether they improve ADL performance after two~     protocols of ET: 1) traditional ET (TET; endurance exercises of the lower-limbs and~     strengthening exercise for upper- and lower-limbs) and 2) TET + additional upper-limb~     endurance exercise (AULET). Methods: Patients with COPD (n= 64) will be included in this~     randomized controlled clinical trial. Before randomization to TET or AULET patients will be~     evaluated regarding physical activity in daily life (PADL; accelerometers), lung function~     (plethysmography), respiratory muscle strength (maximum ins- and expiratory pressures), body~     composition (bioelectrical impedance), performance in ADL (Londrina ADL protocol), maximum~     exercise capacity (symptom limited maximum test of lower and upper limbs), submaximal~     exercise capacity (endurance time at 80% of the maximum upper- and lower-limb capacity),~     functional exercise capacity (six-minute walk test and six-minute pegboard and ring test),~     peripheral muscle strength (one-repetition maximum test and dynamometry), healthy-related~     quality of life (Chronic Respiratory Questionnaire), health status (COPD assessment test),~     functional status (London Chest Activity of Daily Life scale) and symptoms of anxiety and~     depression (Hospital Anxiety and Depression Scale). Patients in both groups will exercise~     three times per week for 12 weeks. TET will be composed by endurance exercise for the~     lower-limbs (walking on treadmill and lower-limb cycling) plus strengthening exercises for~     upper- and lower limbs. Group AULET will perform the same exercises plus the additional~     upper-limb endurance training (upper-limb cycling). Patients will be evaluated by the same~     procedures after the ET. Hypothesis: The addition of upper-limb endurance training will~     increase PADL and ADL performance to a greater extent than the traditional exercise-training~     program alone due to greater reduction of physical activity-related dyspnea.~   "
33546|NCT03127865|"~     The purpose of this study is to compare the sensitivity and the specificity of electrical~     cardiometry to the lung ultrasound in measuring thoracic lung water in pregnant females with~     pre-eclampsia. If electrical cardiometry is validated against ultrasound, it will be easy to~     use with numerical number that will not require advanced experience as with the ultrasound.~   "
33547|NCT03127852|"~     Remote patient monitoring is a potential component for the management of chronic conditions~     that may provide reliable and real-time physiological measurements for clinical decision~     support, alerting, and patient self-management. The purpose of this study is to evaluate an~     UHN-built remote monitoring system for patients with complex chronic conditions called Medly.~   "
33548|NCT03127839|"~     Patients seeking care for shoulder pain will be recruited to enroll will be randomized to one~     of four combined treatment groups; eccentric or traditional strengthening alone and eccentric~     or traditional strengthening with pain neuroscience education. Patients will be followed for~     1 year.~   "
33549|NCT03127826|"~     This is a trial to validate the use of the STarT Back Screening Tool (SBST) in the Military~     Health System for patients with low back pain presenting to primary care.~   "
33550|NCT03127813|"~     Lowering of the pressure in the eye (intraocular pressure, IOP) is the only proven treatment~     for Primary Open-angle Glaucoma (POAG). However, even effective reduction of IOP by~     pharmacological or surgical means does not always change the course of the disease or prevent~     the onset of glaucoma. Some people with POAG also suffer from Obstructive Sleep Apnoea (OSA),~     an increasingly common sleep disorder which is known to affect heart and blood vessels, and~     may contribute to glaucoma progression. OSA is treated with Continuous Positive Airway~     Pressure (CPAP); however using this type of breathing support may raise IOP.~      This study aims to establish whether a short-term application of CPAP in awake subjects leads~     to an increase in IOP. Patients with treated POAG, patients with newly diagnosed untreated~     POAG and control subjects without glaucoma will be included. CPAP will be applied at several~     different pressure levels for a total of 2 hours during which IOP and ocular perfusion~     pressure (OPP) will be measured. If CPAP is shown to raise IOP or alter OPP it could be~     necessary to assess available alternative treatment options for OSA.~   "
33551|NCT03127800|"~     The aim of this study is to investigate the effects of morphine (a drug commonly used for the~     treatment of moderate to severe pain, particularly following surgery) on the number of pauses~     in breathing in patients with moderate obstructive sleep apnoea (OSA). Morphine has been~     shown to reduce upper airway muscle tone and can also cause shallow breathing, which can~     affect breathing function in patients with sleep apnoea. However, to date these effects have~     not been proven in clinical trials. Although, caution is advised when prescribing morphine to~     patients with sleep apnoea, there is currently no strong evidence that morphine makes sleep~     apnoea worse. Only one randomised controlled trial (considered the gold standard in medical~     research) has shown no worsening of symptoms for patients with sleep apnoea. The effect of~     morphine on patients with sleep apnoea will be assessed in a safe, controlled, hospital~     environment. Information from the study will help inform doctors about the safety of giving~     morphine to patients with sleep apnoea in urgent situations, for example after surgery.~      The results of this study will enable clinicians to make better decisions when prescribing~     this drug to patients with OSA in the future.~   "
33552|NCT03127787|"~     The DxN Cytomegalovirus (CMV) assay is an in vitro diagnostic assay intended as an aid in the~     management of CMV-infected individuals undergoing antiviral therapy. the purpose of the study~     is to establish the clinical performance of the DxN CMV Assay for plasma samples in the~     intended use population.~   "
33553|NCT03127774|"~     Objectives:~      - To determine intraperitoneal (IP) progression free survival after optimal debulking and~     heated intraperitoneal chemotherapy (HIPEC) with cisplatin in patients with IP spread of~     adrenocortical cancer.~      - Determine morbidity of this procedure in this patient population.~      - Determine the impact of surgery and HIPEC on quality of life (QOL) and hormone excess.~      - Examine patterns of recurrence (local versus systemic).~      - Determine overall survival after optimal debulking and HIPEC in patients with IP spread of~     adrenocortical cancer.~   "
33567|NCT03127592|"~     This Phase III study will compare the efficacy and tolerability of a Fixed Dose Combination~     of Etodolac + Cyclobenzaprine versus the isolated drugs in postoperative pain control after~     impacted third molar extraction.~   "
33554|NCT03127761|"~     Multiple myeloma (MM) is the second most common hematologic malignancy in adults. The current~     standard of care for MM patients fit to undergo high dose conditioning chemotherapy is an~     autologous HCT (autoHCT). Allogeneic HCT (alloHCT) is the only potentially curative therapy~     available to patients with MM. However, the significant morbidity and mortality of this~     procedure historically limited its application in older patients.~      Thus, although potentially curative, standard risk MM patients have excellent prognoses in~     the era of novel therapies which reduces the overall benefit of alloHCT. However, because the~     outcomes for high-risk MM remain poor despite the best available standard therapies (overall~     survival of 24-36 months), initial data suggest that alloHCT should be explored in this~     subset.~   "
33555|NCT03127748|"~     With advances in interventional cardiac catheterization, ventricular septal defect (VSD)~     could be successfully treated via transcatheter device closure. Cardiac catheterization team~     of National Taiwan University Children's Hospital has recently treated more than 60 patients~     with VSD using this technique. Both treatment effect and follow-up results were encouraging.~     Of particular notice is that many patients experienced subjective improvement in exercise~     tolerance after VSD closure. Traditionally, VSD could only be repaired by open-heart surgery~     under cardiopulmonary bypass. Therefore, VSD closure would be considered only for those with~     moderate to large defect, significant heart failure, or presenting with significant exercise~     intolerance. With the success in transcatheter closure of VSD, a procedure which is safer and~     leading to faster recovery comparing to cardiac surgery, device closure of VSD would be a~     reasonable and sensible treatment of choice if it is beneficial for long-term cardiac~     function and exercise performance.~      This project will prospectively enroll 50 patients with VSDs subject to transcatheter closure~     of the defect in our institute. Before device closure and 6 months after closure,~     participants will be assessed with image studies (including speckle tracking and tissue~     Doppler echocardiography), measurements of serum biomarkers (including B-type natriuretic~     peptide and biomarkers of collagen metabolism), and standard cardiopulmonary exercise test.~     The purpose of this study is to investigate the potential benefits of closing VSD with~     respect to cardiac function and exercise performance, which might serve as basis to redefine~     future indication of VSD closure.~   "
33556|NCT03127735|"~     To determine the maximum tolerated and / or recommended Phase II dose of oral mutant IDH1~     (mIDH1) inhibitor BAY1436032 and to characterize its safety, tolerability, pharmacokinetics,~     pharmacodynamics, and preliminary clinical efficacy in patients with mIDH1-R132X advanced~     acute myeloid leukemia (AML)~   "
33557|NCT03127722|"~     This study is designed to assess post-procedural outcomes for women who chose to undergo~     either hysteroscopic sterilization (Essure®) or laparoscopic tubal sterilization, including:~        -  Pelvic and/or lower abdominal pain~        -  Abnormal uterine bleeding~        -  Surgical intervention (including insert removal and hysterectomy)~        -  Allergic, hypersensitivity, or autoimmune-like reactions~   "
33558|NCT03127709|"~     The purpose of this study is to try to understand how histopcytosis can cause symptoms or~     problems in the brain. The tests being done in the study will look at memory and thinking as~     well as brain function via MRI scan.~   "
33559|NCT03127696|"~     Faecal microbiota transplantation (FMT) represents a clinically feasible way to restore the~     gut microbial ecology, and has proven to be a breakthrough for the treatment of recurrent~     Clostridium difficile infection. Furthermore, clinical trials are being conducted to evaluate~     its use for other conditions including inflammatory bowel disease, irritable bowel syndrome,~     diabetes mellitus, non-alcoholic steatohepatitis and hepatic encephalopathy. Early results in~     human have shown that FMT from lean donor when transplanted into subjects with metabolic~     syndrome resulted in a significant improvement in insulin sensitivity and an increased in~     intestinal microbial diversity, including a distinct increase in butyrate-producing bacterial~     strains. The therapy is generally well tolerated and appeared safe. No clinical studies have~     assessed the efficacy of FMT in obese subjects with type 2 diabetes mellitus.~   "
33560|NCT03127683|"~     The influence of different head and neck positions on the effectiveness of ventilation with~     the Ambu AuraGain airway remains unevaluated.~      This study aimed to evaluate the influence of different head and neck positions on~     ventilation with the AuraGain airway.~      An AuraGain will be placed in all patients, and mechanical ventilation will be performed~     using a volume-controlled mode with a tidal volume of 10 ml/kg.~      The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and~     ventilation score will be assessed first for the neutral head position and then for the~     extended, flexed, and rotated head positions in a random order.~   "
33561|NCT03127670|"~     Solanum melongena is a common vegetable contains phytochemicals which prevent, reduce or~     delay the oxidation of DNA and alter the cellular signal transduction pathways controlling~     cell proliferation and apoptosis of human cancer. The skin of Solanum melongena peel contains~     nasunin an anthocyanins and chlorogenic acid which have anti-inflammatory, antioxidant,~     antimutagenic and antiangiogenic properties. Extract of Solanum melongena is used in actinic~     keratosis and Squamous cell carcinoma of the skin. This study will determine any change in~     arsenical skin lesion after administrating Solanum melongena extract cream.~   "
33562|NCT03127657|"~     Cock's comb extract is rich in hyaluronic acid, which is used as viscosupplementation~     injection and oral supplementation for osteoarthritis. Hyaluronic acid acts as humectants and~     topical moisturizing agent to the skin due to excellent moisturizing property. It has~     anti-inflammatory effect and used in the treatment of ulcer healing and to reduce the~     intensity of radioepithelitis. It is also used as a topical vehicle for the delivery of drug~     to the skin in actinic keratosis. In the case of arsenical keratotic nodule, topical~     application of hyaluronic acid may tends to decrease keratosis by repeated hydration of the~     skin. Therefore, the study will be conducted to determine any beneficial effect of topical~     application of cock's comb extract in the treatment of the patients with severe palmar~     arsenical keratosis.~   "
33563|NCT03127644|"~     To assess efficacy of 5 g three times daily (TID) and 10 g TID ZS versus placebo in Japanese~     patients with hyperkalemia (serum potassium [S-K] ≥ 5.1 mmol/L and ≤ 6.5 mmol/L).~   "
33564|NCT03127631|"~     RADICAL PC1 is a prospective cohort study of men with a new diagnosis of prostate cancer.~     RADICAL PC2 is a randomized, controlled trial of a systematic approach to modifying~     cardiovascular and lifestyle risk factors in men with a new diagnosis of prostate cancer.~   "
33569|NCT03127553|"~     The purpose of this clinical study is to evaluate the health properties of a dietary~     intervention carried on with an innovative low-salt bread.~      The hypothesis is that the introduction of a low-sodium bread as part of a low-salt diet may~     improve the compliance to the own regime and that the vascular function, the inflammatory and~     oxidative state, the composition of the intestinal microbiota and that neurocognitive and~     neurodegenerative processes can improve in hypertensive patients fed a low-salt diet with~     low-salt bread.~   "
33570|NCT03127514|"~     The CENTAUR trial will be a 2:1 (active:placebo) randomized, double-blind, placebo-controlled~     Phase II trial to evaluate the safety and efficacy of AMX0035 for the treatment of ALS.~   "
33571|NCT03127475|"~     Different conditions of gait ignition freezing, spontaneous freezing during walking and~     turning freezing on encountering obstacle will be investigated in fMRI study to examine~     whether different regions of brain will be involved under different conditions of freezing.~     We hypothesize that anterior cortical regions will engage in gait ignition failure, deep~     locomotion regions will be responsible for spontaneous freezing and schema regions will be~     involved in the generation of turning freezing on seeing the barrier. In the third part of~     the project, we will deliver a 5-day session of transcranial direct current stimulation~     (tDCS) to the motor cortex of the FOG patients to examine whether the intervention will~     benefit the patients. Based on the signal source findings, we will investigate whether the~     possible tDCS beneficial effect will be different or similar in patients with different~     electric sources. In addition, how long the possible beneficial effect of tDCS can be~     consolidated after the 5-day course of stimulation is crucial and requires to be elucidated~     under the research project. We aim to peep the myth of FOG in PD by the multi-modality~     approach and hope the study will benefit the long suffering patients.~   "
33572|NCT03127462|"~     60 newly referred patients with psoriasis at the Department of Dermatology and Allergy,~     Herlev and Gentofte Hospital, Denmark will be consecutive included in the study. In the first~     phase of the study 30 patients will receive standard treatment (control group) and in the~     following phase 30 patients will receive the individualized conversational/educational~     intervention (intervention group).The rationale for using a historical control group instead~     of a randomised control group is that it inreal-life setting is unpractical to realize a~     communicative intervention, because clinicians unintentional can intervene against the~     control group.~      The first conversation will take place when the newly referred patient has initiated a new~     treatment. The rational for this is that the time of transition from private practice to the~     Department of Dermatology and Allergy is characterised by failed treatment, typically~     phototherapy or topical. This meaning that newly referred patients current needs is to get~     their psoriasis under control. When patients have initiated a medical treatment they will be~     more motivated and have better surplus to engage in the conversational/educational~     intervention.~      Patients in the intervention group will receive an individual face-to-face conversation with~     a duration of 45 min. All patients will have access to telephone counselling by their primary~     nurse when needed and able to arrange a new face-to-face conversation. After 4-6 weeks the~     face-to-face the nurse will of conversation reach out to the patient by phone to follow up on~     the earlier conversation. Three months after the face-to-face conversation the nurse will~     offer the patient a closing face-to-face conversation of 15 min at the same time where the~     patient has a doctor appointment at the department. Those who are in the control group will~     continue standard care and not receive any conversation and be used as the control group.~      The intervention will be provided by a team of specialized dermatological nurses who have~     received a formal training on patient-centred communication, Self-regulatory Model/Common~     Sense Model interviewing, the life with chronic disease and action plan support.~   "
33573|NCT03127449|"~     This study is conducted to assess the safety, tolerability and preliminary efficacy of~     AST2818 in patients with advanced Non Small Cell Lung Cancer (NSCLC).~   "
33574|NCT03127436|"~     Non-interventional Study to Assess the Tolerability and the Safety Profile of SCIT therapy~     With Acarovac® Hausstaubmilbe~   "
33575|NCT03127423|"~     Previous evidence indicated that the outcomes of both video-assisted thoracoscopic surgical~     ablation and percutaneous radiofrequency ablation therapy for persistent atrial fibrillation~     (AF) were unsatisfied. Recently, hybrid ablation therapy for AF had encouraging outcomes.~     However, there were no randomized, controlled clinical studies to prove the effectiveness of~     this new strategy. This study is aimed to compare the outcomes of hybrid ablation with~     video-assisted thoracoscopic surgical ablation for persistent AF with enlarged left atrium.~   "
33576|NCT03127410|"~     The objective in this study is to determine the predictive validity of a set of special~     clinical tests in identifying those who will respond to lumbar traction~   "
33577|NCT03127397|"~     This study evaluates the effects of praise message phone calls on antiretroviral therapy~     (ART) initiation, adherence, and prescription refills. The investigators will use~     randomization to assign newly (diagnosed) HIV positive, ART naive, female sex workers (FSWs)~     in Ethiopia to a praise message phone call study arm or to a standard of care control study~     arm.~   "
33578|NCT03127384|"~     The purpose of this study is to evaluate performance and safety of Restylane Lidocaine for~     treatment of depressed facial acne scars~   "
33579|NCT03127371|"~     This study aims to describe the safety and efficacy of adjunctive nitrous oxide to lidocaine~     anesthesia in decreasing pain in adults during incision and drainage (I&D) of cutaneous~     abscesses in the emergency department (ED). Incision and drainage has been considered one of~     the more painful procedures performed in the ED. Standard care recommends a minimum of local~     anesthesia, however, there is no consensus on the appropriateness of pain management during~     ED painful procedures, such as incision and drainage. Oligoanalgesia continues to be a~     problem for ED health care providers. Despite extensive research in mechanisms of pain,~     factors relating to inadequate pain management, and evidence-based pain management~     strategies, implementation of effective pain management in the ED is still lacking. Nitrous~     oxide is a weak sedative agent with analgesic and anxiolytic properties. Rapid onset and~     short duration of action, ease of use, and favorable cardio-respiratory profile makes it an~     ideal agent for analgesia in the ED and may provide a novel strategy for pain management in~     I&D. While it has been studied an adjunct to laceration repair in children and labor in~     women, the use in the ED setting is not known. Adult patients capable of consenting, with~     simple cutaneous abscess requiring incision and drainage are the targeted population.~     Eligible patients who consent to the study will be randomized to one of two groups: nitrous~     oxide/local anesthesia or oxygen/local anesthesia. Primary endpoints assessed will be pain~     scores using the VAS at baseline, ten minutes after NO administration, immediately post I&D~     procedure, and ten minutes after procedure completion. Additionally, secondary endpoints of~     patient and physician procedure satisfaction scores, total time of nitrous oxide used, and~     presence of adverse events, including respiratory depression defined by peripheral SaO2 below~     92%, ETCO2 level above 50, a rise or decrease of 10% above or below baseline, the loss of the~     ETCO2 waveform for more than 15 seconds. The vital signs, medical conditions, demographics,~     and abscess dimensions will also be collected.~   "
33591|NCT03127215|"~     Evaluation of the efficacy of the combination of olaparib and trabectedin in adult patients~     with locally advanced/metastatic solid tumors that failed standard treatment and whose~     molecular sequencing tumor profiles show homologous recombination repair (HRR) defects. The~     primary objective is to show superior disease control rate in patients with HRR-deficient~     tumors treated with olaparib and trabectedin compared to treatment according to current~     guidelines (physician's choice). This trial aims to establish whether the PARP-dependency of~     HRR-deficient tumors across entities can be exploited for therapeutic benefit.~   "
33592|NCT03127202|"~     Evaluation of three left ventricular pacing polarities effectiveness to narrow phrenic nerve~     stimulation.~   "
33580|NCT03127358|"~     People who Inject Drugs (PWIDs) constitute 60% of the approximately 5 million people in the~     United States infected with hepatitis C virus (HCV). Successful HCV treatment leading to~     sustained viral response (SVR) is associated with increased survival, but to date successful~     treatment of PWIDs has been limited. Treatment of PWIDs is complex due to addiction, mental~     illness, poverty, homelessness, lack of positive social support, poor adherence-related~     skills, low motivation and knowledge, and poor access to and trust in the health care system.~     At Albert Einstein College of Medicine, the investigators have developed a multidisciplinary~     model of HCV care that integrates on-site primary care, substance abuse treatment, and~     HCV-related care within opiate agonist treatment clinics. To optimize HCV treatment outcomes,~     the investigators have introduced directly observed therapy (DOT). In our DOT model, one~     daily dose of oral HCV medication is administered with methadone. However, DOT is not~     feasible for PWIDs who are not enrolled in methadone maintenance treatment programs, and is~     less effective for methadone-maintained PWIDs who do not attend the methadone clinics every~     day. In addition, DOT has been used for decades both to measure and maximize adherence for~     treatment of tuberculosis infection, but the cost and logistical complexity of administering~     DOT for large HCV clinical programs would be prohibitive.~   "
33581|NCT03127345|"~     This is a randomized clinical trial comparing Omegaven® treatment with standard of care~     (soybean-based lipid formulation, Intralipid®) on bone health outcomes in infants with~     esophageal atresia (EA) undergoing surgical repair at Boston Children's Hospital.~   "
33582|NCT03127332|"~     The overarching objective of this study is to close clinical knowledge and performance gaps~     by providing oncology clinicians with the latest advances and emerging research in the~     evidence-based and personalized treatment of metastatic breast cancer patients. In addition,~     the research team seeks to meet quality measures relevant to value-based care delivery~     through IT infrastructure and clinical workflow processes. The research team also hopes to~     gain insights into clinician practice patterns related to metastatic breast cancer, and the~     correlation between the reported goals of care for patients with metastatic breast cancer,~     and the patients' fit/frailty status and treatment decisions.~   "
33583|NCT03127319|"~     The purpose of this study is to assess the efficacy and safety of patients who receive~     apatinib plus docetaxel and zoledronic versus docetaxel and zoledronic alone as second line~     treatment for advanced non-squamous non-small cell lung cancer with bone metastases.~   "
33584|NCT03127306|"~     Between 40 to 70% of patients with critical illness experience moderate to severe pain.~     Diagnosing pain and assessing its severity is difficult in non-verbal patients both in an~     Intensive Care Unit and in Postoperative Unit after a major surgery such as cardiac surgery).~     In patients who are unable to self-report pain, we use behavioural pain scales, namely BPS -~     Behavioural Pain Scale.~      Aim: The aim of this study was to validate the Polish version of a behavioural pain~     assessment method - BPS in intubated, sedated patients after cardiac surgery versus self~     assessment of pain using Numeric rating scale (NRS) in both delirious and non-delirious~     patients (assessed using Confusion Assessment Method for ICU, CAM-ICU).~      Method: A prospective observational cohort study will include 60 patients. The patients will~     be observed by two trained observers during a nociceptive procedure (position change), both~     during analgosedation and analgesia. Patients will be observed 5 minutes before, during, and~     15 min after the two sets of interventions (six assessments in total). Each BPS assessment~     will be carried out by two observers blinded to each other. To validate the Polish BPS~     translation we will use the following methods: calculations of interrater reliability,~     criterion validity and discriminant validity.~   "
33585|NCT03127293|"~     Hyperemesis Gravidarum (HG) is a common disorder for hospitalization in the first trimester~     of pregnancy and related to protracted vomiting and nausea. It can be accompanied by~     ketonuria, dehydration and weight loss. Our aim was to investigate osteoporosis in patients~     with HG. In our study, we investigated osteoporosis in a total of 79 patients (40 HG and 39~     control) by means of dual energy x-ray absorptiometry (DEXA) measurements and laboratory~     parameters related to HG.~   "
33586|NCT03127280|"~     This is a randomized comparative trial investigating two different catheter management~     strategies among post-gynecologic surgery patients. Women undergoing any benign gynecologic~     surgery wherein they are anticipated to stay at least overnight and in whom no prolapse or~     urinary tract surgery was concurrently performed, will be randomly assigned to either~     conventional urinary catheter care removal on post-operative day 1 or same day surgery~     urinary catheter removal. Patient satisfaction and lower urinary tract symptoms including~     urine culture and antibiotic use will be tracked across both cohorts over the 2 weeks~     following the index surgery.~   "
33587|NCT03127267|"~     The objective is to compare the efficacy and safety of masitinib in combination with riluzole~     versus corresponding placebo in combination with riluzole in the treatment of patients~     diagnosed with Amyotrophic Lateral Sclerosis (ALS).~   "
33588|NCT03127254|"~     The purpose of this study is to learn more about the content of and benefits of making video~     testimonials in adolescents with cancer.~   "
33589|NCT03127241|"~     Restore a lost function is a special experience for people affected by neuromuscular~     evolutive diseases. From the patient's point of view improvement is measured by regaining~     lost abilities,-by being able to do something -anything-today I couldn't do yesterday .~     Upper limb pain, stiffness and activity limitations have a crucial role in reducing patients'~     autonomy and worsening quality of life.~      Real users' needs have been identified thought several workshops, and even if the commercial~     products might assure a benefit to some users and meet most of their requirements, so far a~     validation of the use of such devices by people with neuromuscular disease is missing.~      We aim at field-testing the improvement in arm functions provided by the use of some~     commercial devices and assessing their impact to users' quality of life and independence.~     This step is essential to assure a widespread accessibility to these devices for most of the~     potential users, possibly providing health providers with direction and guidance towards~     Health Technology Assessment.~      Clinical Trial design - The study proposes on-field validation of JAECO WREX, passive~     antigravity exoskeleton; and Armon Ayura, motorized arm exoskeleton for gravity compensation~     in a randomized controlled trial with crossover design. The clinical study will is~     multi-centric, involving both MEDEA and VALDUCE, and received the Ethical Committee approval.~   "
33594|NCT03127176|"~     The gut microbiota is a complex community comprising around 10^14 bacteria that live in the~     gut lumen. The imbalance of the normal structure and function of the microbiota, defined as~     dysbiosis, has been related to a wide diversity of pathologies, including mental health~     disorders. However, clinical evidence of the relationship between microbiota and mood~     disorders is lacking. The aim of this project is to examine the possible relationship of gut~     dysbiosis and the diagnosis of bipolar disorder (BD), of gut dysbiosis and mood relapses and~     of gut dysbiosis and cognitive impairment in bipolar patients.~   "
33595|NCT03127163|"~     To determine whether the implantation of an intrastromal corneal ring is an effective~     treatment for a homogeneous group of mild keratoconus patients.~   "
33596|NCT03127150|"~     With the development of pancreatic surgery, the surgeon has put more emphasis on chylous~     fistula as the postoperative complications in recent years. The diagnostic criteria and~     treatment methods about chylous leakage have been developed and improved in clinical~     practice. However, there remains controversy about the high risk factors and efficient~     control measures during the perioperative period.~   "
33597|NCT03127137|"~     Cervical radicular pain is relatively common, often treated with epidural steroid injection~     (ESI), when conservative treatments like oral analgesics, physical therapy and activity~     modification have failed. There are no universal clinical practice guidelines for the use of~     diluents when CESI are performed.~      Interlaminar CESI may be performed with or without the use of local anesthetics, due to~     training bias or theoretical concerns of weakness. CESI without the benefit of local~     anesthetic as a steroid diluent increases the latency of pain relief and may decrease~     diagnostic information immediately after a CESI with regard to pain generators responsible~     for symptoms, and may potentially decrease patient satisfaction.~      By evaluating the effects of local anesthetic as a diluent during interlaminar cervical ESI,~     we will enhance the safety of this treatment with regard to expectations of objective motor~     weakness as well as post procedure pain control and patient satisfaction in the recovery~     phase after the injection procedure.~      Research Question:~      Does lidocaine versus saline as a steroid diluent effect objective upper extremity strength~     following cervical epidural steroid injection in patients being treated for cervical~     radiculitis?~      Null Hypothesis:~      Cervical epidural steroid injections that include local anesthetic as a diluent have no~     effect on objective upper extremity strength following the injection.~      We hypothesized that cervical epidural lidocaine will cause an objective decrease in strength~     in functional movements of the upper extremity.~   "
33598|NCT03127124|"~     This is a phase 1b/2 study to evaluate the safety and efficacy of NANT-008 in combination~     with 5-fluorouracil, bevacizumab, leucovorin, and oxaliplatin in patients with metastatic~     pancreatic adenocarcinoma.~   "
33599|NCT03127111|"~     The goal of this laboratory research is to look for genetic and epigenetic markers that can~     predict which patients with stage III colorectal cancer will benefit from fluorouracil-based~     adjuvant chemotherapy.~   "
33600|NCT03127098|"~     This is a phase 1b/2 study to evaluate the safety, tolerability, and efficacy of ETBX-011~     vaccine used in combination with ALT-803 in subjects with locally advanced or metastatic~     CEA-expressing cancers whose tumor has recurred after standard-of-care treatment.~   "
33601|NCT03127085|"~     Patients with a history of atrial fibrillation (AF) who frequently attend the emergency~     department (ED) with symptoms may not require emergency treatment, and may be more~     appropriately managed in an alternative outpatient setting. This may be the result of~     inappropriate or inadequate advice or a lack of patient understanding. The main research~     objective pertains to the reason for seeking medical attention for AF in the ED, ED~     management of the patient, outcomes of ED care and alternative strategies.~   "
33602|NCT03127072|"~     To date no prospective trials have been completed that demonstrated whether RFA is an~     effective adjunct to systemic chemotherapy (target therapy) with respect to advantages in~     overall survival compared with chemotherapy (target therapy) alone. The primary objective of~     this trial is to determine overall survival for patients with colorectal cancer liver~     metastasis are treated with radiofrequency ablation plus chemotherapy ± target therapy,~     compared to chemotherapy ± target therapy only.~   "
33603|NCT03127059|"~     Dyspnoe can disable patients with asthma. Dysfunctional breathing (DB), resulting in dyspnoe,~     can mimic or exaggerate asthma. Around every forth patient with asthma have DB. Breathing~     exercises (BrEX) can improve asthma-related quality of live (QOL) in less severe asthma. No~     study has investigated the effect of BrEX on QOL neither on level of physical activity in~     severe asthma.~      A randomised controlled multicentre trial will include 220 adults with poor asthma control~     (Asthma Control Questionnaire (ACQ6)-score≥1.5) from five outpatient departments. Patients~     will be allocated to either usual care (no intervention) or breathing exercises~     (BrEX)-treatment consisting of 12-week intervention including three physiotherapist-sessions~     focusing on breathing pattern modification (Papworth Method; Buteyko technique) in rest and~     activity and 10 minutes home-exercise twice daily. Primary outcome is change in Mini Asthma~     Quality of Life Questionnaire (MiniAQLQ) at six-months follow-up.~   "
33604|NCT03127046|"~     To evaluate the drug-drug interaction between aceclofena and esomeprazole~   "
33605|NCT03127033|"~     Conventional complete overdenture will be made to ectodermal dysplasia patients, a week after~     delivery and after 3 months Patient satisfaction, retention and periodontal condition will be~     assessed. the denture will be taken from the patient for 2 weeks.Acrylic telescopes will be~     replaced with soft liner and again Patient satisfaction, retention and periodontal condition~     will be assessed a week after delivery and 3 months later.~   "
33606|NCT03127020|"~     The main goal of this study is to determine the Maximum Tolerated Dose (MTD) and the~     Recommended Phase II Dose (RP2D) as well as preliminary antitumor activity of PQR309~     administered orally, as once daily capsules continuously and on intermittent schedule, in~     patients with relapsed or refractory lymphomas.~   "
33607|NCT03127007|"~     The study has a phase Ib and a phase II part. The phase Ib part of the study aims to~     determine the safety and tolerance of administration at a fixed dosing of 1200 mg / 3 weeks,~     concomitantly to the standard preoperative radio-chemotherapy.~      The phase II part of the study aims to explore efficacy of atezolizumab in combination with~     the standard preoperative chemo/radiotherapy in stage II and III rectal cancers.~   "
33638|NCT03126591|"~     The purpose of this study is to evaluate the safety of olaratumab plus pembrolizumab in~     participants with previously treated advanced or metastatic soft tissue sarcoma.~   "
33609|NCT03126968|"~     Bleeding poses potential for significant complication after transbronchial lung biopsies. The~     investigators hypothesize that prophylactic intrabronchial instillation of topical~     epinephrine will reduce the likelihood of bleeding. The investigators plan a double-blind,~     placebo controlled trial to evaluate this hypothesis.~   "
33610|NCT03126955|"~     Our team recently described a new medical condition called HELPS~     (Hemi-Laryngo-Pharyngeal-Spasm) syndrome(1). HELPS syndrome is a condition caused by a blood~     vessel pinching the nerve rootlets of the Vagus nerve (Xth cranial nerve). It is similar to~     the well recognized hemifacial spasm syndrome but the nerve involved is the Vagus instead of~     the Facial nerve. As a result, the symptoms are episodic throat contractions and cough. The~     throat contractions become stronger and more frequent over the years and can lead to a~     terrifying inability to breath. Patients may end up intubated in the Emergency Department or~     with a tracheostomy because of inability to breath during a severe episode. Some but not all~     of our patients can tell which side of their throat (left or right) contracts during a~     choking episode. In between these choking episodes, patients feel normal. A surgical cure for~     these patients is Microvascular Decompression of the Xth nerve.~   "
33611|NCT03126942|"~     The objective of this explanatory mixed methods study is to compare a novel attachment system~     (Novaloc) to a traditional alternative (Locator) for single implants in the mandible of~     edentate elders. The investigators will carry out a randomized cross-over clinical trial~     comparing Novaloc attachments to Locators for single-implant mandibular overdentures in~     edentate elders. Participants will be followed for three months with each attachment type;~     patient-based, clinical and economic outcomes will be gathered. A sample of 26 participants~     is estimated to be required to detect clinically relevant differences in terms of the primary~     outcome (patient ratings of general satisfaction). Participants will choose which attachment~     they wish to keep, then be interviewed about their experiences and preferences with a single~     implant prosthesis and with the 2 attachments. Data from the quantitative and qualitative~     assessments will be integrated through a mixed-methods explanatory strategy. A last~     quantitative assessment will take place after 12 months with preferred attachment; this~     latter assessment will enable the observation of attachments' long-term wear and maintenance~     events.~   "
33612|NCT03126929|"~     This study aims to provide, in a large sample, further psychometric data as regards the~     internal consistency, the test-retest reliability and the diagnostic validity of the Coma~     Recovery Scale-Revised (CRS-R).~   "
33613|NCT03126916|"~     This partially randomized phase III trial studies iobenguane I-131 or crizotinib and standard~     therapy in treating younger patients with newly-diagnosed high-risk neuroblastoma or~     ganglioneuroblastoma. Radioactive drugs, such as iobenguane I-131, may carry radiation~     directly to tumor cells and not harm normal cells. Crizotinib may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. Giving iobenguane I-131 or~     crizotinib and standard therapy may work better in treating younger patients with~     neuroblastoma or ganglioneuroblastoma.~   "
33614|NCT03126903|"~     To evaluate the safety and probable benefit of the KeraKlear Non-Penetrating Keratoprosthesis~     when implanted in an eye with corneal opacity that is at high risk of complications with PK.~   "
33615|NCT03126890|"~     Linezolid is the second line agent in the treatment of MRSA and PRSP infections, and it is~     also the drug of choice for VRE infections. It can be an alternative option against multidrug~     resistant tuberculosis and non-tuberculosis mycobacterium. However, Patients who receive more~     than 2 weeks of treatment duration and who have renal dysfunction or severe cirrhosis may~     prone to experience anemia, thrombocytopenia, and leukopenia. Long-term use may also result~     in lactic acidosis, peripheral neuropathy and optic neuropathy due to mitochondrial toxicity.~     Thus, this study will analysis the medical charts in National Taiwan University Hospital~     (NTUH) from 2011 to 2016 to get the population demographics who use linezolid and analysis~     the occurrence rate of myelosuppression, neuropathy and lactic acidosis. Simultaneously, the~     investigators also use therapeutic drug monitoring (TDM) to prospectively evaluate the~     association of linezolid blood concentration and clinical efficacy and safety. The result of~     this study will provide physicians more information to prevent concentration-dependent~     adverse effects.~   "
33616|NCT03126877|"~     The objective of this study is to evaluate the Raindrop® Near Vision Inlay for the~     improvement of near vision in presbyopic patients with treatments to optimize the ocular~     surface before corneal inlay surgery.~   "
33617|NCT03126864|"~     The goal of this clinical research study is to learn about the safety and tolerability of 3~     different doses of CD33-CAR-T cells (referred to throughout the consent as T-cells) in~     patients who have CD33-positive acute myeloid leukemia (AML) that is relapsed (has come back)~     or refractory (has not responded to treatment).~      CD33-CAR-T is made by genetically modifying (changing) your T-cells (a type of white blood~     cell). T-cells are genetically changed to help target leukemia cells.~   "
33618|NCT03126851|"~     This study seeks to identify ways to help parents safely use cough/cold medications with~     their children. The study focuses on 3 key tasks that have been found to be difficult for~     parents: 1) decision-making about whether medicines should be given based on a child's age,~     2) use of active ingredient information to determine which medications are safe to give~     together, and 3) medication dosing.~      Specific ways that labels and dosing tools can be changed to improve parent understanding and~     ability to use pediatric cough and cold medications will be tested. This includes looking at~     whether including age restriction information on the front panel helps parents make better~     decisions about whether a medication should be given to a child, as well as whether presence~     of a specific warning or pictogram can help improve this understanding. In addition, the role~     of font size, including a box around ingredients, and use of a specific warning to look at~     and compare active ingredients, will be examined to see if these can help parents decide if~     two medications can be given together safely. Finally, dosing charts with pictograms of~     dosing tools, and provision of certain dosing tools, can lead to fewer parent dosing errors.~      A label/dosing tool combination that incorporates what is learned from the first part of the~     study will be developed based on findings from the first part of the study, and then tested~     to see whether this improves parent understanding and use of pediatric cough and cold~     medicines.~      Hypotheses include: 1) changes in labels and dosing tools, such as including explicit~     warnings, and pictographic warnings/instructions can improve parent understanding and ability~     to act on of medication instructions, 2) parents with low health literacy and/or LEP will~     especially benefit from strategies such as explicit wording, warnings, and pictogram, and 3)~     parents receiving the comprehensive labeling and dosing strategy will have a better~     understanding of appropriate use of cough/cold medications, including fewer dosing errors,~     compared to standard labels.~      A multi-part experiment will be conducted. Findings will be merged with known evidence around~     health literacy best practices to develop a comprehensive, consumer-centered strategy for~     English and Spanish-speaking parents. Pilot testing of the comprehensive strategy in~     comparison to existing labels will then take place.~   "
33619|NCT03126838|"~     This study evaluates incidence of diaphragmatic dysfunction after cardiac surgery and its~     effect on outcome of surgery.~   "
33620|NCT03126825|"~     Acute in-booth assessment of a new noise reduction algorithm with cochlear implant~     recipients.~   "
33621|NCT03126812|"~     This is a single arm feasibility study in patients with primary FIGO stage IV serous ovarian,~     peritoneal, or fallopian tube cancer to evaluate neo-adjuvant + adjuvant pembrolizumab for~     its capacity to induce and broaden T cell responses against tumor neo-antigens.~   "
33622|NCT03126799|"~     Korean data of treating EGFR mutation positive NSCLC patients with Erlotinib and Bevacizumab~     is significantly necessary for developing new standard treatment in first-line therapy in~     Korean EGFR mutant NSCLC patients.~      In this study, The investigators will investigate the efficacy and safety of Erlotinib and~     Bevacizumab combination compare to Erlotinib alone in Korean EGFR-mutant NSCLC patients.~   "
33623|NCT03126786|"~     The purpose of this trial is to evaluate the safety and efficacy of suprachoroidal CLS-TA~     used with intravitreal aflibercept in subjects with DME.~   "
33624|NCT03126773|"~     To evaluate the patients' satisfaction with Angeliq Micro in real clinical practice after 13~     cycles of treatment.~   "
33625|NCT03126760|"~     This is a multicenter, multiple dose study to estimate the response rate, and examine the~     safety of H.P. Acthar® Gel (Acthar) in subjects with RRMS who have not responded to high dose~     steroids. Approximately 66 subjects will be randomized.~   "
33626|NCT03126747|"~     This study is a Japanese post-marketing surveillance (PMS) which is required by the~     regulatory authorities. General objective of PMS is to confirm the clinical usefulness,~     especially the safety profile of a drug under the routine clinical practice.~   "
33627|NCT03126734|"~     This study aims to analyze whether the course of infant massage serves as a tool to improve~     acceptance, commitment and awareness of influence of parents of babies with Down syndrome.~     These variables will be measure before and after the course of infant massage in the~     experimental group, investigators will make measurements with the same rate in the control~     group, but they will receive the course after the measurements.~   "
33628|NCT03126721|"~     This is a drug interaction study to evaluate the PF-06751979 at steady state on the~     pharmacokinetics of oral midazolam single doses in fixed sequences including single dose~     midazolam alone in period 1 followed by multiple doses of 100 mg PF-06751979 once a day for~     11 days with single dose midazolam co-administered on Day 10 in period 2~   "
33629|NCT03126708|"~     This is an open-label, randomized, controlled trial. At the end of a 28-day screening period,~     all eligible subjects will be randomly assigned into treatment Arm A or B in a 1:1 ratio.~     Subjects in Arm A will receive a maximum of 6 cycles of chemotherapy (cisplatin plus~     paclitaxel) and cetuximab weekly in the absence of progressive disease (PD), as assessed by~     the Investigator, and unacceptable toxicity. After 6 cycles of treatment, subjects who derive~     clinical benefit will continue treatment with cetuximab as monotherapy until either PD or~     unacceptable toxicity. Subjects in Arm B will receive the same chemotherapy regimen as Arm A~     alone for a maximum of 6 cycles in the absence of PD and unacceptable toxicity.~   "
33630|NCT03126695|"~     To evaluate the relative bioavailability of ticagrelor for the different formulations. A~     randomized cross-over design has been chosen to minimize the effects of between-subject~     variability and any period effects on the overall results.~   "
33631|NCT03126682|"~     The purpose of the study is to examine the effect of bupropion on seizure threshold and~     duration in depressed patients receiving right unilateral ultra-brief electroconvulsive~     therapy (ECT). The investigators plan to recruit 10 patients into the study, administer~     sustained release (SR) bupropion 4 hours prior to receiving ECT. The investigators plan to~     compare the seizure threshold and seizure durations between ECT sessions with and without~     bupropion administration. The study's implication is to examine how ECT can be optimized by~     rational combination with medications that lower seizure threshold.~   "
33632|NCT03126669|"~     The Brain uses 20% of the total oxygen supply consumed by the entire body. Even though, less~     than 10% of the brain is active at every given time, the brain utilizes almost all the oxygen~     delivered. In order to perform different tasks or more than one task (multi-tasking), the~     oxygen supply is shifted from one brain region to another, via modulation of blood perfusion.~      The aim of the present study was to evaluate whether hyperbaric oxygen (HBO) environment,~     with increased oxygen supply to the brain, will enable better performance of complex and/or~     multiple activities.~      Methods: a prospective, double blind randomized control, cross over trial including healthy~     volunteers. Participants were asked to perform a cognitive task, a motor task and a~     simultaneous cognitive-motor task (multi-tasking). Participants were randomized to perform~     the tasks at 2 environments: (a) normobaric air (1ATA 21% oxygen) (b) HBO (2ATA 100% oxygen).~     Two weeks later participants were crossed to the alternative environment. Blinding of the~     normobaric environment was achieved in the same chamber with masks on while hyperbaric~     sensation was simulated by increasing pressure in the first minute and gradually decreasing~     to normobaric environment prior to tasks performance.~   "
33633|NCT03126656|"~     The main of the study is to evaluate the effect of testosterone on ventricular repolarization~     in patients with mild heart failure, at risk for sudden cardiac death. The~     electrocardiographic markers studied are QT variability index, the short term variability~     index.~   "
33634|NCT03126643|"~     At BMS, we work with physicians/investigators to make investigational products available to~     patients with life-threatening diseases that have exhausted other treatment options and where~     there is a reasonable expectation of benefit over risk.~      When contacted by a treating physician, BMS will consider requests for providing early~     patient access to Nivolumab in pediatric patients exhibiting a high mutational load.~   "
33635|NCT03126630|"~     This randomized phase I/II trial studies the side effects and how well pembrolizumab with or~     without anetumab ravtansine work in treating patients with mesothelin-positive pleural~     mesothelioma. Monoclonal antibodies, such as anetumab ravtansine and pembrolizumab, may~     interfere with the ability of tumor cells to grow and spread.~   "
33636|NCT03126617|"~     At BMS, we work with physicians/investigators to make investigational products available to~     patients with life-threatening diseases that have exhausted other treatment options and where~     there is a reasonable expectation of benefit over risk.~      When contacted by a treating physician, BMS will consider requests for providing early~     patient access to Elotuzumab in patients with multiple myeloma who are residents of Belgium,~     Thailand, Turkey, Argentina, and Colombia.~   "
33637|NCT03126604|"~     A cross sectional study for assessment of pelvic floor functions after 6 months to 4 years~     after normal vaginal delivery or Cesarean section~   "
33639|NCT03126578|"~     This is a single center, non-randomized, open-label, fixed sequence study to investigate the~     effect of multiple oral dosing of LEO 32731 (up-titrated), on CYP3A activity in healthy male~     subjects using midazolam as a probe CYP3A substrate.~      The study will be conducted in two seamless parts:~      Part I - Maximal Tolerated Dose (MTD) Part II - Drug-Drug Interaction with midazolam~   "
33640|NCT03126565|"~     This study is being done to evaluate the impact of a system called CareSage. The CareSage~     system is a technology that uses clinical data to monitor, identify and target care to~     patients at risk of being transported to the hospital. The investigators want to see whether~     the CareSage system is effective in helping to identify hospital admissions which can be~     prevented.~   "
33641|NCT03126552|"~     Four healthy hookworm-naive volunteers will be exposed to 50 L3 Necator americanus larvae~     once and will retain infection for up to 2 years.~   "
33642|NCT03126539|"~     This study aims to compare the expression of keratins before and after application of~     sulforaphane (SF) to determine whether this agent alters skin fragility seen in both~     intrinsic and extrinsic skin aging and UV light exposure.~   "
33643|NCT03126526|"~     This research project aims to explore the effectiveness of a computerised intervention as a~     treatment for eating disorders, particularly binge eating disorder and bulimia nervosa. Two~     interventions will be used to target cognitive processes: 1) food-specific inhibitory control~     training and 2) implementation intentions.~      The full intervention is 4 weeks long and consists of completing the training and food~     diaries every day and meeting with the researcher twice for EEG recording and taste tests.~     Moreover, it involves completing questionnaires at baseline, at intervention completion, and~     one month after the intervention.~      Moreover, healthy control participants will be recruitment to complete baseline~     questionnaires and take part in one EEG recording session in order to assess baseline~     differences in brain activation in response to computer tasks.~   "
33644|NCT03126513|"~     Refractory gastroparesis is a disease characterized by a delayed gastric emptying without a~     mechanical obstruction. Actual treatments have a limited efficacy and gastric per-oral~     endoscopic myotomy (G-POEM) is a new treatment that has demonstrated initial promising~     results in these patients. The investigators aims are to evaluate security and efficacy of~     this endoscopic treatment in participants with refractory gastroparesis.~   "
33645|NCT03126500|"~     Malnutrition is common problem in hospitalized geriatrics at discharge. Malnutrition is a~     high risk for functional limitations, impaired muscle strength and reduced quality of life.~   "
33646|NCT03126487|"~     This is a non-randomized, prospective phase II trial evaluating an innovative treatment,~     focused MRI-guided ultrasound, as thermic destruction in primitive small size breast cancer.~   "
33647|NCT03126474|"~     Wrist (distal radius fractures) are very common injuries. Despite this there is still much~     controversy about the best way to treat them and in particular which ones require~     intervention. Many studies have been carried out but there is no strong evidence to answer~     these questions. The investigators are carrying out a Delphi study which involves seeking~     consensus from experts at treating these injuries about the best way to manage them. UK and~     international expert surgeons will take part in three rounds of online questionnaires to help~     decide how much displacement of the fracture will trigger treatment for different common~     wrist fracture cases. The aim of the study is to obtain expert opinion through consensus from~     the expert group about the amount of displacement that is acceptable until intervention is~     required.~      This will provide guidance and reduce variation between treating surgeons.~   "
33648|NCT03126461|"~     A one-arm, single center phase 2 trial of SAbR plus ipilimumab plus nivolumab in advanced~     metastatic melanoma patients~   "
33649|NCT03126448|"~     The purpose of this research project is to improve understanding of the potential role of~     highly sensitive bacterial tests in diagnosing infected non-healing fractures compared to the~     current standard of care, microbiologic culture (growing bacteria from tissue specimens in~     the laboratory).~      In order to understand the validity of the highly sensitive tests, parameters of the test in~     different groups of patients must be established. This study is examining how two highly~     sensitive tests compare to each other and to the standard of care (microbiologic culture) in~     three groups of patients.~      Group 1 is clean broken bone surgery undergoing plate and screw fixation, intramedullary~     nailing fixation where the fracture site is accessible, or staged treatment of a broken bones~     initially treated by joint spanning external fixation device. Group 2 will include patients~     having a plate and screws removed without clinical evidence of infection. Group 3 will be~     patients undergoing an initial procedure for fracture nonunion.~   "
33650|NCT03126435|"~     The aim of this adaptive Phase 3 trial is to show a statistically significant superiority of~     EndoTAG-1 in combination with gemcitabine compared to gemcitabine monotherapy in patients~     with locally advanced/metastatic pancreatic cancer after FOLFIRINOX failure.~   "
33651|NCT03126422|"~     The investigators aimed to investigate the effects of pretreatment with different doses of~     dexmedetomidine on the cough caused by fentanyl during anesthetic induction.~      Patients undergoing elective surgeries under general anesthesia will be randomly allocated to~     4 groups (n = 60, each group). Dexmedetomidine 0, 0.03, 0.06, and 0.09 μg/kg/min will be~     pump-administered in 10 mins to groups I, II, III, and IV, respectively, followed by the~     induction of general anesthesia with intravenous fentanyl 4 μg/kg. The incidences and~     severity of cough that occurred within 2 min after the injection of fentanyl will be~     recorded, and the incidences of cardiovascular adverse events that occurred between the~     administration of the dexmedetomidine infusion and 2 min after tracheal intubation will be~     recorded.~   "
33652|NCT03126409|"~     This study evaluates the short-term patency of vein graft harvested by the No-Touch technique~     compared to that by the conventional approach in patients undergoing isolated~     on-pump/off-pump coronary artery bypass graft (CABG) surgery. a total of 2000 patients~     undergoing isolated on-pump/off-pump CABG will be consecutively recruited from 7 hospitals~     across China and randomly assigned to receive No-Touch saphenous vein harvesting or~     conventional approach. All participants will be invited for clinical follow-up and 64-slice~     multislice computed tomography angiography (MSCTA) analysis at 3 months post-operatively.~   "
33653|NCT03126396|"~     Assessment of efficacy & tolerance of Urgo 310 3166 dressing in the treatment of local venous~     or mixed leg ulcers.~   "
33654|NCT03126383|"~     The AMISS study will characterize the features of muscle disease in patients with primary~     Sjogren's syndrome (pSS).~   "
33655|NCT03126370|"~     This study will evaluate the effect of ledipasvir/sofosbuvir (LDV/SOF) treatment on the~     pharmacokinetics (PK) and renal safety of tenofovir in the form of tenofovir alafenamide~     (TAF). Subjects living with human immunodeficiency virus (HIV) who are receiving~     tenofovir-based antiretroviral therapy (in the form of tenofovir disoproxil fumarate [TDF]),~     and are also taking a ritonavir- or cobicistat-boosted protease inhibitor will be invited to~     participate.~      The study will consist of five visits: a screening visit, three abbreviated 4-hour~     pharmacokinetic visits, and one end-of-study follow-up visit.~      Subjects will also be asked to use a Wisepill device, which will track medication adherence~     throughout the study.~   "
33656|NCT03126357|"~     This study will examine elements of abuse liability (AL) related to potential product~     adoption of three electronic tobacco vapor products by current smokers relative to high and~     low AL comparator products (usual brand cigarette and nicotine gum, respectively). Changes in~     subjective measures, speed and amount of nicotine uptake, and maximum changes in~     physiological effects during and after product use that follows a 12-hour (minimum) tobacco~     and nicotine abstinence period, will be determined. The electronic tobacco vapor products~     will not be compared to each other.~   "
33657|NCT03126344|"~     This study was designed to determine the comparison between the King Vision video~     laryngoscope 、 McGrath MAC video laryngoscope and Macintosh laryngoscope for nasotracheal~     intubation.Patients were divided into 3 groups of 30 patients each.Patients of King Vision~     group [n=30]、 McGrath MAC group [n=30] and Macintosh group[n=30]were intubated using~     respective devices.This study is the first to search the use of King Vision video~     laryngoscope for nasotracheal intubation.~   "
33658|NCT03126331|"~     This study is being done with patients with advanced kidney cancer (also called renal cell~     carcinoma or RCC). This is a research study involving the use of the drug Nivolumab (also~     known as Opdivo®). Nivolumab is an anti-PD-1 antibody. It works by attaching to and blocking~     a molecule called PD-1. PD-1 is a protein that is present on different types of cells in the~     immune system and controls parts of the immune system by shutting it down. Antibodies that~     block PD-1 can potentially prevent PD-1 from shutting down the immune system, thus allowing~     it to recognize and help destroy cancer cells. In many countries (including the United~     States, European Union and Japan) Nivolumab is approved to treat certain cancer types. The~     purpose of the study is to test the safety and effectiveness of nivolumab in patients with~     advanced RCC when given intermittently.~      Nivolumab is approved by the U.S. Food and Drug Administration (FDA) for the treatment of~     advanced kidney cancer, non small cell lung cancer, classical Hodgkin Lymphoma and Metastatic~     Melanoma. Nivolumab is FDA-approved for advanced RCC because has been shown to shrink RCC~     tumors that have spread outside the kidney.~   "
33659|NCT03126318|"~     This is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety,~     pharmacokinetics, and pharmacodynamic effects of a single dose of the study drug or placebo~     administered subcutaneously to patients with moderate-to-severe chronic kidney disease and~     persistent inflammation.~   "
33660|NCT03126305|"~     The clinical component of Phase I application development examines the clinical utility,~     feasibility, and functionality of the OC-Go application via an 8-month pilot trial consisting~     of 50 standard CBT sessions augmented with OC-Go in OCD-diagnosed children who are receiving~     treatment through the pediatric OCD treatment programs in the UCLA Division of Child and~     Adolescent Psychiatry~   "
33661|NCT03126292|"~     The objective of this study is to conduct a 12-month pilot longitudinal study of a~     parent-directed program delivered in a primary care setting serving primarily low-income~     families. The parent-direction program will be evaluated in a randomized controlled design to~     determine the feasibility of protocol implementation and to investigate the potential impact~     on parental outcomes. Process outcomes will include success with recruitment, participant~     retention, and ability to collect outcome measures. Clinical outcomes will incorporate~     measures of parental self-efficacy and parenting behaviors, including observational~     assessments of parent-child interactions.~   "
33662|NCT03126279|"~     Painful osteoarthritis (OA) is the 4th largest cause of disability in the UK. Preoperative~     temporal summation, a measure of central pain facilitation, has been shown to predict~     postoperative pain after total knee replacement surgery (TKR). The assessment of the brain's~     response to noxious stimuli using non-invasive functional MRI (fMRI) may be key in~     identifying imaging biomarkers within the brain that map central sensitization changes seen~     in OA. fMRI may help explain why up to 20% of patients undergoing TKR surgery develop~     persistent post-operative pain. To test these concepts the study aims to functionally~     characterise the brain activity related to temporal summation of pain in healthy individuals~     and OA patients using a novel fMRI cuff algometer. Assessment of outcomes in terms of pain~     and function will be performed 6 months post TKR surgery~   "
33663|NCT03126266|"~     This is a single-arm, non-randomized study of re-irradiation of diffuse intrinsic pontine~     glioma (DIPG)~   "
33664|NCT03126253|"~     Childhood anemia is a global public health problem that is associated with life-threatening~     consequences such as growth retardation, impaired motor and cognitive development, and~     increased morbidity and mortality. Anemia can be caused by a variety of factors such as~     nutritional deficiencies (i.e., iron, folic acid, vitamin B12, and vitamin A), infections~     (i.e., helminth), and blood disorders (i.e., hemoglobinopathies). The World Health~     Organization (WHO) estimates that approximately 50% of anemia cases can be attributed to iron~     deficiency. This is an estimated global average that varies widely depending upon the~     location in question. The World Bank estimates for 2011 claim that approximately 55.60% of~     all Bangladeshi children under five years of age are suffering from anemia. The relationship~     between socioeconomic status (SES) inequality and anemia among the children has never been~     conclusively and it is unclear if the children of the age group of 6-59 months have uniformly~     high levels of anemia during all the stages of development, e.g., during the infant, toddler,~     and preschool stages. In addition, there is a dearth of evidence from Bangladesh, where the~     meaning of sociodemographic characteristics may be different from that in other countries.~     Therefore, this study attempts to fill the above-mentioned lacuna by investigating and~     evaluating the association of SES inequality, among other explanatory variables, on the~     development of childhood anemia during different stages of child development and to answer~     the questions: (a) Is SES a factor impeding childhood anemia along with other explanatory~     variables? (b) In which stage of child development, the chance of disparaging with childhood~     anemia is highest? (c) Is there evidence of between child development stages differences in~     the strength and form of association disparities between having childhood anemia and SES? (c)~     What are the predictive margins for SES-associated anemia in the case of infants, toddlers,~     and preschool children? The results of this analysis will be reported for elucidating the~     potential effects of SES and the stages of child development that are usually neglected in~     the conventional scientific literature. Moreover, as anemia is one of the current key health~     issues in Bangladesh, it is also expected that the findings of this study would contribute~     significantly toward shaping the health policy strategy of the country.~   "
33702|NCT03125759|"~     This observational study aims to research whether there is a relationship between omentin and~     ischemic stroke on the aspects of incidence, severity, and recovery etc.~   "
33665|NCT03126240|"~     The increasing prevalence of obesity noticed in recent decades is a major public health~     problem of pandemic nature. According to researches, there will be 2.3 billion overweight~     adults and more than 700 million people suffering from obesity worldwide by the year~     2020.Series of epidemiologic studies has revealed a relative link between morbid obesity and~     metabolic syndrome type 2 diabetes mellitus, hypertension, hyperlipidemia, insulin resistance~     and shorter life span. Dyslipidemia specially when combined with obesity significantly~     increase the incidence of atherosclerosis and its complications and also insulin resistance~     and hence control of diabetic patients. Hyperlipidemia is widely recognized as one of the~     main co- morbidities in severe obesity and major risk factor for development of~     atherosclerosis and then heart related diseases.Bariatric surgery has become a prominent~     treatment modality after the rapidly increasing prevalence of obesity.~   "
33666|NCT03126227|"~     This is a multicenter, randomized, double-blind, placebo-controlled safety study of AR101~     using the characterized oral desensitization immunotherapy (CODIT ™) regimen in~     peanut-allergic children.~   "
33667|NCT03126214|"~     The purpose of this study is to compare the effectiveness of prescribing oral anticoagulation~     therapy by pharmacist intervention compared to enhanced usual care in participants with~     unrecognized AF and/or known AF but not taking blood thinners.~   "
33668|NCT03126201|"~     Focal segmental glomerulosclerosis (FSGS) is one of the most common primary glomerular~     diseases leading to end stage renal disease. In this study, our aim is to evaluate the~     effects of histopathological, clinical, and laboratory features of patients with primary FSGS~     on the disease progression.~   "
33669|NCT03126188|"~     The aim of the present study will be to observe the changes in the NTs like Nerve growth~     factor, Neurotrophin-3, and Neurotrophin-4 in patients with depression and study the effect~     of various antidepressants like Sertraline (SSRI), Dosulepin (TCA), and Venlafaxine (SNRI) on~     their levels.~   "
33670|NCT03126175|"~     For the non-surgical treatment of distal radius fractures in adults a variety cast options~     are available, including or not the elbow joint. The literature is inconclusive regarding the~     need to immobilize the elbow joint after reduction of the distal radius fracture.This study~     was undertaken to evaluate the best method of immobilization between the above and~     below-elbow cast groups at the end of 6 months of follow-up.~   "
33671|NCT03126162|"~     The objective of this study is to determine if backfilling the bladder immediately~     post-operatively, prior to removal of the foley catheter, in patients undergoing same-day~     total laparoscopic hysterectomy will hasten time to first spontaneous void and time to~     discharge~   "
33672|NCT03126149|"~     The current study is the first clinical trial proposed with PF-06667272. It is designed to~     evaluate the safety, tolerability, and pharmacokinetics (PK) of single ascending doses of~     PF-06667272 under fed and fasted conditions, in healthy adult subjects.~   "
33673|NCT03126136|"~     Fetal heart rate abnormalities are common. Miller et al. have demonstrated that new onset~     fetal heart rate abnormalities after initial labor epidural dosing occur more frequently in~     women with a low admission pulse pressure than those with a normal admission pulse. The aim~     of the present study is to look for a statistical link between the occurrence of a fetal~     heart abnormality requiring an intervention and maternal hemodynamic factors (blood pressure,~     pulse pressure, and cardiac output) measured before epidural analgesia in two positions:~     dorsal decubitus position and in the left lateral decubitus.~   "
33674|NCT03126123|"~     Anal condylomatosis is an anal canal mucosa pathology caused by HPV infection (Human~     Papilloma Virus). This condition is common, especially in immunodepressed patients.~      These lesions are not accessible to topical medical treatment because of their location. They~     should be treated surgically because they may degenerate into squamous cell carcinoma.~      In the operating room, lesions are identified by a complete proctologic examination, more or~     less supplemented by an acetic acid test. Acetic acid allows to detect mucous degeneration~     (dysplasia) in the form of intense bleaching. The interpretation of this test may~     nevertheless be difficult in case of local inflammation or scarring. These false positives~     may lead to unnecessary surgical gestures. The surgical procedure consists of a mucosectomy~     or destruction of the condylomatosis by electrocoagulation.~      The acetic acid test is used at the discretion of the surgeon. However, there is little data~     on its performance or consensus on its use.~   "
33675|NCT03126110|"~     The purpose of this study is to determine the safety, tolerability, and efficacy of~     INCAGN01876 when given in combination with immune therapies in subjects with advanced or~     metastatic malignancies.~   "
33676|NCT03126097|"~     The primary purpose of this study is to evaluate the effect of single and multiple doses of~     JNJ-64155806 on the steady-state pharmacokinetics (PK) of ethinylestradiol and drospirenone~     and vice versa in healthy female participants.~   "
33677|NCT03126084|"~     This study compares analgesic effectiveness of transversus abdominis plane block and~     quadratus lumborum block type 2 in open hernia repair surgery. All of the patients will~     receive routine intravenous analgesic regimen. In addition to that one-third of the patients~     will receive transversus abdominis plane block, one-third will receive quadratus lumborum~     block type 2. One-third of the patients will not receive any blocks and will constitute the~     control group~   "
33678|NCT03126071|"~     The objective is to investigate the efficacy and safety of raltitrexed-based chemotherapy~     plus bevacizumab in the treatment of advanced colorectal cancer~   "
33679|NCT03126058|"~     This study is aimed to evaluate the safety of applying enhanced recovery after surgery for~     colorectal cancer.~   "
33680|NCT03126045|"~     Lumbar punctures are implemented for the diagnosis of patients with hematologic symptoms as~     well as for the intrathecal chemotherapy injections. Post lumbar puncture headache is a~     common complication for patients and is characterized by the occurrence of a headache with an~     orthostatic component, with additional symptoms such as nausea. Some studies in neurology,~     anesthesia and gynecology have previously shown a decreased incidence for post lumbar~     puncture headache while using atraumatic needles as compared to standard needles. In this~     context, it is necessary to better document the incidence of post lumbar puncture headache~     with the use of atraumatic needles in hematologic patients.~   "
33730|NCT03125395|"~     A Rollover Safety Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Years and Older With~     Cystic Fibrosis, Homozygous for F508del~   "
33681|NCT03126032|"~     Aim of the study is to evaluate to what extent a glycocalyx damage measured in the ER in~     patients presenting with sepsis correlates with their clinical course and if it can be used~     as a clinical stratification tool and mortality predictor.~      The study will focus on the changes of the microcirculation and how they correlate with the~     macrocirculation, as well as microbiologic parameters. In the study will participate ca. 300~     patients with sepsis, as well as 30 patients without sepsis and 30 healthy individuals.~   "
33682|NCT03126019|"~     The purpose of this study is to assess the objective response rate of INCB050465 treatment in~     subjects with relapsed or refractory follicular lymphoma.~   "
33683|NCT03126006|"~     The main objective of this study is to determine whether the provision of non-surgical~     periodontal therapy to pregnant women with periodontitis is effective in reducing the~     incidence of low birth weight, preterm birth and still birth when compared to pregnant women~     with periodontitis but who will be provided with oral hygiene instructions alone.~   "
33684|NCT03125993|"~     1.Objective~      The investigators aim to determine the effect of brisk walking prescription (> 10000 steps, >~     five days, per week) on body components and metabolic risk factors among patients with~     overweight/obesity. The objectives are as follow:~        1. The body components changes before/after the brisk walking prescription (> 10000 steps,~          > five days per week) intervention in overweight/obesity population;~        2. The metabolic risk factors changes before/after the brisk walking prescription (<10000~          steps or <five days per week) intervention in overweight/obesity population~      2.Study design This study is a prospective 4-month follow-up scheme in which patients were~     treated with the following intervention: > 10000 steps, > five days, per week. For individual~     follow-up, body components and metabolic risk factors will be tested before and after the~     study. Every participants will be followed up in community visits every month.~      3. Statistical analysis Statistical analysis will be performed using SPSS 16.0 version~     package (SPSS Inc., Chicago, IL.). Numerical data will be presented as mean ± standard~     deviation for normal distribution or otherwise median (interquartile range). Two-sided~     independent t-test is adopted for between-group comparison on end-points with normal~     distribution, otherwise non-parametric test. Row-Column table will be analyzed through~     chi-square test. P<0.05 is taken as statistical significant.~   "
33685|NCT03125980|"~     Adjuvant chemotherapy has been widely adopted worldwide for locally advanced colon cancer.~     However, more and more studies have found better efficacy and potential advantages of~     perioperative or neoadjuvant chemotherapy. The sooner the systemic chemotherapy is received,~     the better suppression it has on activity of tumor growth factors. Pre-operative chemotherapy~     may eliminate tiny metastases. It may also shrink the invasion of tumor before surgery, and~     thus reducing operational trauma and expediting recovery. With advances in radiology and~     tomography, staging before surgery is accurate enough to identify risks and prognosis for~     patients. The phase II trial conducted by our department has yielded encouraging results~     (N=47, CapeOX regimen, clinicaltrials.gov NCT02415829): after the neoadjuvant chemotherapy,~     no subject had disease progression, 68.1% subjects reached complete or partial response.~     Besides, the toxicity of neoadjuvant CapeOX chemotherapy was acceptable. The present~     randomized controlled phase III trial will be conducted to further compare efficacy and~     safety of the neoadjuvant and adjuvant CapeOX chemotherapy for patients with locally advanced~     resectable colon cancer in China. This study may have two periods, each will last for~     approximately 5 years. After the first period (n=994), if the results of the test group are~     better than the control group, the study will be terminated. Otherwise, the study will enter~     into period 2 (n=376) through selecting out genetically sensitive subjects and repeating the~     same trial process as period 1.~   "
33686|NCT03125967|"~     The purpose of this study is to assess the safety and efficacy of daily morning exposure to~     colored light in patients receiving acute inpatient rehabilitation services for stroke,~     traumatic brain injury, or non-traumatic brain injury with sleep disturbances such as poor~     nighttime sleep and/or excessive daytime sleepiness.In a two-arm randomized~     placebo-controlled study with pre-exposure and post-exposure assessments, we are comparing~     the effects of daily morning exposure to either blue light or red light on objective sleep~     quality, subjective sleep quality, functional rehabilitation outcomes, cognitive symptoms,~     fatigue, and neurological symptoms.~   "
33687|NCT03125954|"~     This is an objective cohort study using objective recording of physical activity~     (accelerometry) during and after the GLAiD intervention to investigate if a sedentary~     behavior change by participating in an 6-week physiotherapy-led exercise and education~     program (GLAiD) occurs. The GLAiD intervention is an education and exercise based~     intervention aiming at decreasing pain and improving function in patients with knee~     osteoarthritis.~      The primary outcome is change in objective recorded physical activity between baseline and~     follow-up.~   "
33688|NCT03125941|"~     The aim of this study is to investigate the effect of a single preoperative high-dose steroid~     injection on complications in the immediate postoperative phase after breast cancer surgery,~     with removal of the breast (mastectomy). Primary outcome is the proportion patients who~     require transfer to the post anaesthesia care unit (PACU) and the proportion that can be~     transferred directly to the ward. Secondary outcomes are organspecific complications in the~     postanasthesia phase, pain and nausea the first 5 days, seroma and wound infection the first~     14 days and readmissions the first 30 days after surgery.~      The investigators hypothesize that the frequency of transfer to the PACU and organspecific~     complications will be lower among patients receiving high dose dexamethasone. The~     investigators hypothesize, that there will be no difference in wound infections, seroma or~     readmissions.~   "
33689|NCT03125928|"~     This is a single arm, Phase IIA clinical trial assessing the safety and efficacy of~     atezolizumab in combination with paclitaxel, trastuzumab, and pertuzumab in 50 patients with~     locally advanced, unresectable, or metastatic HER2-overexpressing breast cancer. Due to~     concerns that corticosteroids may have a negative effect on tumor immunity expected with~     addition of atezolizumab to the standard of care regimen, patients will receive premedication~     with dexamethasone only for weeks 1 and 2 of the weekly paclitaxel, and then corticosteroid~     premedication will be discontinued subsequently.~      Patients must have pathologically confirmed HER2-overexpressing breast cancer that is locally~     recurrent, unresectable, or metastatic, with measurable disease as defined by RECIST v1.1.~     Tumor measurements and bone scans will be performed every 9 weeks while patients are on~     study.~   "
33690|NCT03125915|"~     The proposed study developed and tested two adjunct components for use in Couples HIV Testing~     and Counseling (CHTC) with gay-male couples: a communication skills training video and a~     substance use agreement module. Phase I of the study involved the creation of intervention~     materials and Phase II was comprised of a small randomized controlled trial comparing the~     additive effects of the novel components to CHTC as usual.~   "
33691|NCT03125902|"~     This Phase 3, multicenter, randomized, double-blind, placebo controlled study is designed to~     evaluate the efficacy and safety of atezolizumab (MPDL3280A, an anti-programmed death-ligand~     1 [PD-L1] antibody) administered in combination with paclitaxel compared with placebo in~     combination with paclitaxel in participants with previously untreated, inoperable locally~     advanced or metastatic, centrally confirmed TNBC. Participants will be randomized in a 2:1~     ratio to receive atezolizumab or placebo plus paclitaxel until disease progression or~     unacceptable toxicity or end of study, whichever occurs first (maximum up to approximately 45~     months).~   "
33692|NCT03125889|"~     A single-arm prospective, interventional clinical trial to evaluate the safety and~     performance of obtaining hemostasis following prostate resection using the AQUABEAM for~     treatment of LUTS resulting from BPH.~   "
33693|NCT03125876|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and~     pharmacodynamics (PD) of CT053PTSA in Relapsed/refractory AML patients with FLT3 gene~     mutation.~   "
33694|NCT03125863|"~     A single-arm prospective, interventional clinical trial to evaluate the safety and~     performance of obtaining hemostasis with commercially approved catheters following prostate~     resection using the AquaBeam for treatment of LUTS resulting from BPH.~   "
33695|NCT03125850|"~     This study will compare the glaucoma day-ward patients' efficacy with inpatients by~     evaluating the glaucoma knowledge, psychology, effect of surgery and complications , and will~     analysis the reasons of the differences. Half of participants will receive treatment in~     day-ward, while the other half will receive treatment in hospital.~   "
33696|NCT03125837|"~     Difficult airway is a major reason of anesthesia related injuries with latent life~     threatening complications. Foresee difficult airway in the preoperative period is vital for~     the patient's safety. The aim of this study is to develop a computer algorithm that can~     detect whether the patient is a difficult airway based on photographs form six aspects. This~     method will be decreased potential complication related to difficult airway and increased~     patient safety.~   "
33697|NCT03125824|"~     To further evaluate accelerated fading resulting from additional treatment sessions of~     Soliton AWD as accessory to laser in tattoo reduction treatment.~   "
33698|NCT03125811|"~     This study will compare two different ways to relieve nausea and vomiting in the Emergency~     Department. The usual treatment for nausea/vomiting is a drug called Zofran, but new studies~     have suggested that smelling alcohol pads can also help to relieve nausea and vomiting.~   "
33699|NCT03125798|"~     Surgical treatment of lung cancer consists of two elements: anatomical lung resection~     (segmentectomy, lobectomy or pneumonectomy) followed by mediastinal lymph node dissection~     (MLND). Since over last 15 years the growing rate of resection is performed by minimal~     invasive approach - video-assisted thoracoscopic surgery (VATS). The study is focused on the~     clinical and technical aspects of MLND during VATS lobectomy. The extension of lymph nodes~     resection is strictly specified. The main benefit of MLND for the patient is precise~     histopathological staging, which allows choosing the best therapeutic option of adjuvant~     therapy. MLND is related with potential minor and major complications (bleeding, increased~     volume of chest tube drainage, prolonged chest tube duration and hospital stay, chylothorax,~     left recurrent laryngeal nerve injury, injury of the bronchus, injury of the esophagus). The~     majority of complications are caused by thermal injury resulting from the use of~     heat-generating monopolar electrocautery that is commonly used during lymph nodes dissection.~     In addition, thermal energy generation in case of monopolar electrocautery may lead to~     systemic inflammatory response and increased surgical injury. High-energy sealing devices~     like LigaSure™ allow for dissection, coagulation and cutting with the single instrument.~     Compared to mechanical ligation techniques (vessel loops, clips) or monopolar electrocautery,~     LigaSure™ technology has been shown to reduce: intraoperative blood loss (in colorectal,~     gynecologic and urologic surgery), surgery time (in colorectal, gynecologic and urologic~     surgery), length of hospital stay (in gynecologic and urologic surgery). Investigators~     hypothesize that application of LigaSure™ in VATS anatomical resection may lead to diminished~     complications rate, lower systemic inflammatory response and shorter length of stay compared~     to monopolar electrocautery.~   "
33700|NCT03125785|"~     Patients with congenital cataract operated at St. Erik Eye Hospital are given the topical~     steroid dexamethasone (Isopto-Maxidex) according to a set treatment plan. They are provided a~     contact lens made of the polymer Filcon 4A that is frequently replaced due to the results of~     previous in vitro studies that have shown accumulation of preservatives in the hydrogel~     contact lens matrix which could question their use in combination with ophthalmic solutions.~     We conducted a pilot study that indicate that the results in vivo are different from the~     results in vitro and we suspect that insignificant amounts of dexamethasone and benzalkonium~     chloride are taken up by the lenses due to tear drainage.~      Contact lenses from 30 patients at St. Erik Hospital that have undergone surgery for~     congenital cataract and are treated with eye drops containing dexamethasone and benzalkonium~     chloride will be collected and analyzed. Ultraviolet-Visible spectrophotometer (UV-vis) and~     Laser desorption ionization-mass spectrometry (LDI-MS) will be used to study uptake and~     release of dexamethasone and benzalkonium chloride. Scanning electron microscopy (SEM) will~     be used to study surface morphology. Thirty Contact lenses from a control group without~     topical treatment will also be analyzed. Data will consist of contact lens material, wearing~     time, pharmaceutical agents, contact lens solution when applicable, diagnosis and possible~     co-morbidity.~   "
33701|NCT03125772|"~     The TUXEDO-India is a prospective, single blind, multi-center randomized clinical trial to~     assess the TAXUS Element™ in a consecutive population of diabetic patients with coronary~     artery disease undergoing coronary revascularization. Approximately 1,830 patients with~     single or multi lesion, multi vessel coronary artery or saphenous vein graft disease ranging~     in vessels ranging from 2.25 mm to 4.0 mm in diameter by visual estimate will be enrolled in~     a 1:1 randomization to TAXUS Element™ vs. XIENCE™ Prime in India at up to 50 clinical sites,~     to demonstrate the safety and effectiveness of TAXUS Element™ in an unrestricted population.~      Procedural Endpoints:~        -  Device success, defined as attainment of < 30% residual stenosis of the target lesion~          (visual assessment) using the TAXUS Element™ or XIENCE™ Prime stent.~        -  Lesion success defined as attainment of < 30% residual stenosis (visual assessment)~          using any percutaneous method.~        -  Procedure success defined as lesion success without the occurrence of in-hospital MACE.~        -  Procedure complication rate including composite and individual angiographic occurrence~          of dissection ≥B, distal embolization, no reflow, slow flow, abrupt closure, or~          perforation.~   "
33703|NCT03125746|"~     1. To evaluate the safety and tolerability of LXI-15029 in Chinese patients with advanced~     malignant solid tumors in monotherapy period, including confirmation of the maximum tolerated~     dose (MTD) of monotherapy. 2.To evaluate the safety and tolerability of LXI-15029 in Chinese~     postmenopausal patients with metastatic or locally advanced breast cancer with estrogen~     receptor (+) and human epidermal growth factor receptor 2 (-) in combined with Exemestane~     period , including confirmation of the maximum tolerated dose(MTD) of the combined therapy~     with Exemestane.~   "
33704|NCT03125733|"~     Zenker's Diverticulum (ZD) is a sac-like outpouching of the lining of the esophageal wall at~     the upper esophagus. It is a rare disease typically seen in the middle-aged and older adults.~     Common symptoms of the disease include difficulties in swallowing (dysphagia), food reflux~     (regurgitation), unpleasant breath smells (halitosis) and couch, choking and hoarseness etc.~     (respiratory complications). Pills lodging in the sac and thus unable to take effect is also~     a common and yet often overlooked problem.~      Traditional treatment for ZD included open resection done by head and neck surgeons and~     direct septum division done by ENT doctors. Septum division done by endoscopists is a new~     modality of treatment and so far has used the same approach as the ENT doctors-the wall~     between the sac and the normal esophageal lumen (the septum) is cut down directly so that~     food will not be held in the sac.~      A cutting-edge endoscopic treatment for ZD is now emerging. In this approach, what we call~     submucosal tunneling endoscopic septum division (STESD), the wall is not cut directly, but~     inside a tunnel created by lifting the wallpaper (the mucosa lining the esophageal wall).~     After the muscle septum is completely cut, the mucosa is then sealed by clips, restoring~     integrity of the esophageal lining.~      The advantage of STESD is twofold. First, the esophageal mucosa will be sealed after the~     operation, so that the chance of extravasation of luminal content with its relevant~     complications will be smaller. Second, under the protection of the tunnel, the endoscopist~     will be able to cut the septum completely down to its bottom, ensuring a more satisfactory~     symptom resolution. In short, our hypothesis is that treating Zenker's diverticulum by the~     tunneling endoscopic technique should be both safer and more effective than traditional~     methods.~   "
33705|NCT03125720|"~     CRT response will be significantly better using image fusion of SPECT MPI and fluoroscopy~     venogram to guide LV lead placement at the latest activation segment without scar than~     standard-of-care implantation.~   "
33706|NCT03125707|"~     To register a large number of patients with the diagnosis of a BCR-ABL 1- negative myeloid~     neoplasm (according to WHO 2008 classification) in participating centers~      To store samples from all patients (e.g. bone marrow aspirate, peripheral blood, plasma, and~     buccal swap, skin biopsy samples in exceptional cases)~      To perform morphologic and genetic analyses~      To assess clinical characteristics and outcome data using a defined catalogue containing~     clinically relevant variables~      To assess biological disease features and correlate with clinical outcome data (prognostic~     and predictive markers)~      To assess quality of life~   "
33707|NCT03125694|"~     This study has been designed to investigate the comparative effects of sitagliptin vs.~     pioglitazone as add-on treatments in patients with type 2 diabetes who were uncontrolled on~     the full-dose of metformin and sulfonylurea~   "
33708|NCT03125681|"~     The purpose of this study is to evaluate the effects of remote ischemic conditioning on~     platelet function during off-pump coronary artery bypass surgery.~   "
33709|NCT03125668|"~     The purpose of this study is to test an educational program with telephone follow-up to~     improve health-related quality of life (HRQoL), treatment adherence, and reduce anxiety and~     depression symptoms in patients who are starting oral anticoagulants (OA).~   "
33710|NCT03125655|"~     Psoriasis is a chronic and recurrent skin disorder characterized by marked inflammatory~     changes in the skin. An extensive cytokine network including generated by activated dendritic~     cells and T cells mediates the formation of psoriatic lesions. These immune-response~     parameters can be used as markers in the severity and management of the disease after further~     in-depth studies.~   "
33711|NCT03125642|"~     This is a phase II study of autologous transplant for patients with Hodgkin (HL) and~     non-Hodgkin lymphomas (NHL) including those who are HIV positive.~   "
33712|NCT03125629|"~     This clinical trial studies how well positron emission tomography (PET)/computed tomography~     (CT) works compared to PET/magnetic resonance imaging (MRI) in evaluating patients with~     cancer. PET/CT and PET/MRI may determine which scanner is best for the patient's type of~     cancer and other types of cancers.~   "
33713|NCT03125616|"~     In the UK, babies receive their vaccinations according to a standard schedule, irrespective~     of their gestation at birth. This policy is designed so that all babies are protected as~     early as possible from vaccine preventable diseases such as polio, diphtheria, tetanus,~     rotavirus, pertussis (whooping cough), Haemophilus influenzae type B, pneumococcal disease~     and now meningococcal B disease. The 4CMenB vaccination (Bexsero®) was added to the UK~     schedule in September 2015 and there has been no research looking at whether the vaccine~     gives the same protection to babies born early as it does to those born at term. The~     Investigators want to compare two different schedules of 4CMenB and see if one gives better~     protection to babies born prematurely. It is possible that an extra 4CMenB dose (i.e. three~     doses in early infancy instead of two) will offer better protection for premature babies.~     This is what the Investigators are trying to find out through this study.~   "
33714|NCT03125603|"~     The immune-related adverse events (irAEs) linked to the important activation of the immune~     system by new immunotherapy treatments in patients affected by Non-small-cell lung carcinoma~     (NSCLC) have not received a lot of systematic study or been monitored over time outside of~     clinical trials.~      This study aims to verify, on the basis of the data collected in a prospective and~     retrospective manner, that the side-effects due of anti-PD-(L)-1 or anti-CTLA-4 treatments~     observed in the target population of the controlled clinical trials are the same as in the~     general clinical population.~   "
33715|NCT03125590|"~     The PEQ is the first tool to measure facilitators, barriers, and preferences to exercise in~     people with osteoporosis.~   "
33731|NCT03125382|"~     Compare use of Carelink system - monitoring system - with traditional in-clinic follow up, in~     patients with implantable cardiac desfibrilator (ICD)~   "
47620|NCT02943590|"~     This research study will test whether atorvastatin, a drug commonly prescribed for reducing~     cholesterol levels, can protect the heart during chemotherapy with doxorubicin. Atorvastatin~     is from a family of medications that are commonly called statins~   "
33716|NCT03125577|"~     The study will evaluate safety and efficacy of a combination of 4th generation chimeric~     antigen receptor gene-modified T cells targeting CD19 (4SCAR19) and CD20 (4SCAR20), CD22~     (4SCAR22), CD38 (4SCAR38) CD70 (4SCAR70) or CD123 (4SCAR123) for patients with B cell~     malignancies. Clinical response and development of a standardized lentiviral vector and cell~     production protocol will be investigated. This is a phase I/II trial enrolling patients from~     multiple clinical centers.~   "
33717|NCT03125564|"~     Irritable bowel syndrome (IBS) is a common functional bowel disorder of the gastrointestinal~     tract affecting up to 20 percent of the adolescent and adult populations (1). It is~     characterised by abdominal pain, irregular bowel habits, altered stool consistencies and~     bloating (2), and is associated with impaired quality of life. IBS can be categorised into~     diarrhoea predominant type (IBS-D), constipation predominant type (IBS-C), and mixed type~     (IBS-M). Fecal microbiota transplantation (FMT) defined as infusion of feces from healthy~     donors to affected subjects has shown impressive results with high cure rates in patients~     with recurrent clostridium difficile infections (10). In a small retrospective study using~     FMT to treat 13 IBS patients, 70% of patients had symptomatic improvement particularly those~     with abdominal pain, dyspepsia, bloating and flatus. Nearly half of the patients achieved~     improvement in overall well-being. The investigators propose a randomised, placebo-controlled~     trial of FMT in patients with IBS. The investigators will assess the fecal and mucosal~     microbiota before and after FMT. Patients will be randomized to either FMT or placebo over a~     12 weeks period.~   "
33718|NCT03125551|"~     Dietary Supplements can affect platelet activation and aggregation, which could result in~     bleeding tendencies. This study wishes to evaluate the influence that these supplements has~     on platelet function using Rotational thromboelastometry.~   "
33719|NCT03125538|"~     Motor imagery practice (MIP), which is the repeated internal representation of a movement~     without engaging its physical execution and which shares a neurofunctional equivalence with~     physical practice, has been show to contribute to promote motor recovery and pain~     alleviation. Despite the extensive body of evidence concerning MIP therapeutic effects, the~     impact of mental training during lower-limb amputees' rehabilitation process remains to be~     investigated. This study was designed to assess MIP effects on the relearning of walking and~     the frequency and intensity of phantom-limb pain among acute lower-limb amputees. Data should~     contribute to scale up the tools made available to therapists and extend the scope of MIP~     application. Moreover, results may contribute to directly provide patients recovering from a~     lower-limb amputation with a cost-effective and adaptable technique that could considerably~     improve their quality of life.~   "
33720|NCT03125525|"~     Migraine is included in the top-ten disabling diseases and conditions among the Western~     populations. Non-invasive neurostimulation (t-SMS), including the Cefaly® device, for the~     treatment of various types of pain is a relatively new field of interest. The aim of the~     present study was to explore the clinical experience with Cefaly® in a cohort of migraine~     patients previously refractory or non-tolerant to topiramate prophylaxis.~      Patients were followed prospectively after having been diagnosed with episodic or chronic~     migraine with a previous failure to topiramate treatment and having consented to receive~     preventive treatment with Cefaly® according to their treating physician's suggestion. A~     1-month period of baseline observation was followed by a 3-month period of active treatment~     with transcutaneous supraorbital nerve stimulation (t-SNS) with Cefaly® as the only~     preventive treatment.~   "
33721|NCT03125512|"~     This is a crossover randomized controlled trial comparing a convenient positional therapy~     (PT) device to continuous positive airway pressure (CPAP) in the treatment of positional~     obstructive sleep apnea (OSA).~   "
33722|NCT03125499|"~     To evaluate the long-term changes in patellar cartilage thickness in TPX-100 versus~     placebo-treated knees in subjects who participated in Study TPX-100-1 or TPX-100-2.~   "
33723|NCT03125486|"~     GlaxoSmithKline (GSK) have submitted a Biologic License Application (BLA) for the~     subcutaneous formulation of belimumab which is currently under review by the Food and Drug~     Administration (FDA). The goal of this individual patient compassionate use supply is to~     provide a patient with subcutaneous belimumab for the period of 1 year or until the~     subcutaneous formulation of belimumab becomes approved for use by the FDA and is commercially~     available to this patient, whichever is sooner. You can access GSK's Policy on Compassionate~     via http://www.gsk.com/media/3368/compassionate-use.pdf.~   "
33724|NCT03125473|"~     A Phase 1b, randomized, double-blind, dose-ranging trial to determine the safety of different~     dosing regimens an adenoviral-vector based norovirus vaccine (VXA-G1.1-NN) expressing GI.1~     VP1 and dsRNA adjuvant administered orally to healthy volunteers~   "
33725|NCT03125460|"~     The objective of this study is to establish the performance characteristics of an assay that~     detects the recurrence of bladder cancer in patients previously diagnosed with bladder~     cancer. The study is conducted at locations within and outside of the United States. Testing~     is performed on urine specimens provided by eligible enrolled patients. Results from this~     study will not be used for patient management decisions.~   "
33726|NCT03125447|"~     Attention functions have a major impact on children's social and school behavior. They are an~     important issue for prematurely born children often seen as having learning difficulties and~     being restless, when it could be an adaptative answer to attention disorders. The aim of this~     study is to evaluate attention capacity in former premature children aged 6-7 years old with~     regards to different postures or mobility, for the attention functions of orienting, alerting~     and executive control. The Attention Network Test using reaction time and accuracy to visual~     stimuli will be used to evaluate attention functions in each posture and mobility.~   "
33727|NCT03125434|"~     This study aims to describe normal spinal musculoskeletal patterns in healthy adolescents and~     young adults by using static and dynamic measures. Static informations are obtained from~     full-spine stereoradiography for skeletal measures and from high-resolution spine muscle MRI~     for muscular data. Dynamics stability is calculated from 3D gait analysis.~   "
33728|NCT03125421|"~     A nursing strategy to prevent pressure sores in the prone position in Acute Respiratory~     Distress Syndrome (ARDS) patients. A multicenter controlled prospective stepped wedge trial.~   "
33729|NCT03125408|"~     The DxN Hepatitis C Virus (HCV) Assay is an in vitro diagnostic assay intended as an aid in~     the management of of HCV-infected individuals undergoing antiviral therapy. The purpose of~     the study is to establish the clinical performance of the DxN HCV Assay for plasma samples in~     the intended use population.~   "
33732|NCT03125369|"~     Type 2 diabetes mellitus (T2DM) is a chronic progressive illness affecting a substantial~     percentage of the general population. While pharmacotherapy remains the mainstay of~     treatment, around 60% of patients cannot achieve the recommended goals for diabetic control.~     Weight control is a well-known essential component in normalizing blood glucose level in~     T2DM. The term metabolic surgery is recently introduced and it is now increasingly accepted~     as a valid option for obese T2DM patients with poor glycemic control despite optimal medical~     therapy. While laparoscopic roux-en-Y gastric bypass (RYGBP) is the gold-standard~     bariatric/metabolic procedure in many countries, it is not widely accepted in Asia. Recently,~     a novel bypass technique called single loop duodenojejunal bypass with sleeve gastrectomy~     (SLDJB-SG) has been developed trying to tackle most drawbacks of RYGBP. Realizing there is a~     knowledge gap in applying the new duodenojejunal bypass procedure to obese T2DM patients, we~     propose to investigate and compare the efficacy of glycemic control and functional outcomes~     of SLDJB-SG with conventional RYGBP.~   "
33733|NCT03125356|"~     The purpose of this study is to determine whether eight weeks of low-calorie sweetener (LCS)~     exposure exerts cardiovascular and/or metabolic effects among LCS-naïve overweight and obese~     adolescents and young adults. We will examine changes in gene expression in subcutaneous fat~     and will correlate these molecular changes with plasma biochemistry.~   "
33734|NCT03125343|"~     A national cohort study with all patients scheduled for neoadjuvant treatment with~     (chemo)radiotherapy or short course radiotherapy with delayed surgery 6-8 weeks) for rectal~     cancer staged as cT4bNX/anycTanycN and cMRF+/anycTanycN and lateral lymph nodes on MRI (and~     patients that have been offered short course raditotherapy with delayed surgery due to~     various reasons). The tumours are positioned midrectal or low and are palpable with the~     finger. The patients offered this treatment after recommendations on their local~     multidisciplinary tumour board will be will be informed and offered to participate in the~     study. Patients scheduled for short course radiotherapy with immediate surgery cannot be~     included.~   "
33735|NCT03125330|"~     This research study is designed to answer the question: How does professional coaching impact~     early career academic emergency medicine physician goal attainment, leadership strengths,~     well-being, and burnout?~   "
33736|NCT03125317|"~     Evaluating the efficacy of Valsalva's maneuver and music therapy on peripheral venous~     cannulation pain and anxiety~   "
33737|NCT03125304|"~     This proposed trial is a multicenter,randomized and controlled clinical trial. The aim of~     this trial is to evaluate the efficacy and safety of acupuncture for treating pain of~     Endometriosis.The trial period will consist of three menstrual cycles of treatment, and three~     menstrual cycles in the follow-up period.We put forward the following hypothesis: the effect~     of acupuncture group is better than the control group on relieving pain.~   "
33738|NCT03125291|"~     This project is a hybrid efficacy/effectiveness trial of a streamlined version of the Bridges~     program, an evidence-based intervention (EBI) to prevent substance abuse and mental health~     disorders. Bridges is an integrated parent-youth intervention evaluated in a randomized~     controlled trial (RCT) with Mexican Americans (immigrant and U.S. born) that showed long-term~     effects on multiple outcomes: substance use initiation and escalation, externalizing and~     internalizing symptoms, deviant peer association, and grade point average (GPA) in early~     adolescence; alcohol abuse disorder, binge drinking, marijuana use, risky sexual behavior,~     diagnosed mental disorder, and school dropout in late adolescence. Building on evidence of~     core intervention components and strategies for redesigning EBIs for the real-world,~     investigators will partner with low-income, multiethnic schools to adapt the program to a~     brief, 4-session format (Bridges short program, BSP), and optimize engagement, delivery,~     training, and implementation monitoring systems to facilitate dissemination and~     sustainability. The proposed RCT will also examine whether a parent-youth EBI can impact~     multiple channels of youth self-regulation (e.g., biological, behavioral, emotional) during~     adolescence when neurobiological systems are changing rapidly, and whether preexisting~     individual differences in self-regulation moderate program effects.~   "
33739|NCT03125278|"~     This is a study to compare patient knowledge about the indications of their medications~     between two sites. Regions Hospital has a population of patients that receive the medication~     indication on the label for any new or changed medications at the time of patient discharge.~     Brigham Women's Health follows a standard policy of discharge medication labels including the~     name of the medication and instructions for use without any indication of what the medication~     is intended to treat. Consented patient will receive a phone call where researchers will ask~     about which medications they are taking and other questions about those medications.~      The study population will be patients recently discharged from the hospital with 1 or more~     new or changed medications~   "
33740|NCT03125265|"~     The DIETary intake, death and hospitalisation in adults with end-stage kidney disease treated~     with HaemoDialysis (DIET-HD) study is a multinational prospective cohort study designed to~     evaluate the association between nutrition and dietary patterns and health outcomes in~     prevalent adult haemodialysis patients in Europe and South America.~   "
33741|NCT03125252|"~     The main objective is to evaluate the impact of the bundle of actions on the delirium's~     incidence in resuscitation patients during their stay in the service, compared to a~     conventional treatment.~      The investigators therefore hypothesize that a set of coordinated paramedical actions in the~     prevention of delirium would reduce its incidence by 15% compared to conventional care.~   "
33742|NCT03125239|"~     This research study is studying a combination of two targeted therapies as a possible~     treatment for acute myeloid leukemia (AML) that has relapsed after initial treatment or did~     not fully respond.~      The name of the study interventions involved in this study are:~        -  Merestinib~        -  LY2874455~   "
33743|NCT03125226|"~     This pilot clinical trial studies how well TracelT hydrogel works in localizing bladder~     tumors in patients undergoing radiation therapy for bladder cancer. TracelT hydrogel marks~     the location of a bladder tumor and makes it more visible during imaging tests. Using TracelT~     hydrogel tissue marker may help doctors learn more about tumor location and altering~     radiation dosage for bladder cancer.~   "
33862|NCT03123406|"~     1. To evaluate achievement ratio of iPTH,Calcium and phosphorus after taking Cinacalcet HCL~          in hemodialysis subjects with mild, moderate and severe SHPT;~        2. To explore the impact of Cinacalcet HCL using on the combined use of drugs;~        3. To explore the difference of patients who continued or discontinued Cinacalcet HCL in~          real-world period from 33rd to 52nd week.~   "
33744|NCT03125213|"~     This is a Phase 2a, multi-center, randomized, double-blind, placebo-controlled study~     evaluating the safety, efficacy, and pharmacokinetics (PK) of AL-3778 in combination with~     Peg-IFN in subjects with Hepatitis B e antigen (HBeAg) positive CHB virus infection who are~     treatment-naïve.~      The study will consist of a screening phase , a double-blind treatment phase followed by~     treatment with Peg-IFN alone, and a post-treatment follow-up phase.~      Approximately 30 subjects to complete the study. Eligible subjects will be randomized into 2~     treatment arms in a 2:1 ratio (active:placebo) to receive one of the following treatments:~        -  Arm A: Peg-IFN plus AL-3778 (N=20)~        -  Arm B: Peg-IFN plus matching placebo (N=10)~   "
33745|NCT03125200|"~     This study evaluates ADCT-502 in patients with Advanced Solid Tumors with HER2 Expression.~     Patients will participate in a dose-escalation phase (Part 1) and dose expansion (Part 2). In~     Part 2, patients will receive the dose level identified in Part 1.~   "
33746|NCT03125187|"~     The purpose of this phase I study is to know the pharmacodynamic profile in in intravenous~     application in humans of the sodium heparin of porcine origin of the company União Química,~     building from the pharmacodynamic data generated its pharmacokinetic profile, due to the~     dosage limitation of heparin directly in biological samples. In addition, the toxicity of the~     product will be evaluated in healthy male participants.~   "
33747|NCT03125174|"~     Analysis of mucus, mucin and DNA concentration, MUC5B/5AC ratio, rheology, osmotic pressure,~     cohesion and nucleotides in sputum on 30 individual samples of good quality in healthy~     individuals and those with bronchiectasis. (60 total)~   "
33748|NCT03125161|"~     To date no prospective trials have been completed that demonstrated whether HAI is an~     effective adjunct to systemic chemotherapy (target therapy) with respect to advantages in~     conversional resection rates and survival compared with chemotherapy (target therapy) alone.~     The primary objective of this trial is to determine conversional resection rates and survival~     for patients with colorectal cancer liver metastasis are treated with HAI plus chemotherapy ±~     target therapy, compared to chemotherapy ± target therapy only.~   "
33749|NCT03125148|"~     Malignant duodenal obstruction in patients not fit for surgery is treated by placing enteral~     stents during endoscopy. These patients may also have poor gastric motility. Hence bridging~     the pyloric opening with the stent along with the duodenal obstruction may deliver better~     symptomatic improvement. Both approaches are commonly clinically practiced but no formal~     comparative studies have been done to compare which one is better.~   "
33750|NCT03125083|"~     The purpose of this study is to determine the role of inflammation in the high prevalence of~     psychiatric disorders in skin-restricted lupus (SRL) patients. SRL is an inflammatory~     disease. Inflammation can lead to a decrease in the synthesis of neurotransmitters via the~     activation of the IDO enzyme and to induce the synthesis of neurotoxic molecules (kynurenin~     pathway). This leads to the development of psychiatric disorders.~      Investigator therefore want to compare inflammation and neurotransmitter synthesis in SRL~     patients according to the presence or absence of psychiatric disorders.~      Investigator expect a decrease in neurotransmitter synthesis and activation of the kynurenin~     pathway in patients with a psychiatric disorder.~   "
33751|NCT03125070|"~     This randomized phase III trial studies health informatics and a self-management program in~     improving the health of cancer survivors after stem cell transplant. After transplant many~     survivors may feel stressed or may be unsure of what health care they need as a transplant~     survivor. A self-management program called INSPIRE, along with a personalized survivorship~     care plan may improve stress and health care for transplant survivors.~   "
33752|NCT03125057|"~     This pilot study aims to evaluate the efficacy and safety of hemoporfin photodynamic therapy~     (PDT) with different light doses for port-wine stain (PWS） in 7-14 years old children. The~     population pharmacokinetics of hemoporfin in children will be investigated as well.~   "
33753|NCT03125031|"~     In this study, the concentration of hemoglobin within the subject's blood will be reduced in~     a controlled manner by administering fluids intravenously. The accuracy of two noninvasive~     hemoglobin sensors will be assessed by comparison to hemoglobin measurements from a~     laboratory analyzer.~   "
33754|NCT03125018|"~     In this study, the level of oxygen within the blood will be reduced in a controlled manner by~     reducing the concentration of oxygen the study volunteer breathes. The accuracy of a~     noninvasive pulse oximeter sensor will be assessed by comparison to the oxygen saturation~     measurements from a laboratory blood gas analyzer.~   "
33755|NCT03125005|"~     In this study, the level of methemoglobin (HbMet) will be increased in a controlled manner by~     administering sodium nitrite intravenously in healthy volunteers. The accuracy of a~     noninvasive HbMet sensor will be assessed by comparison to blood measurements from a~     laboratory analyzer.~   "
33756|NCT03124979|"~     In this study, the level of oxygen within the blood will be reduced in a controlled manner by~     reducing the percentage of oxygen the study volunteer breathes. The accuracy of a noninvasive~     pulse oximeter sensor will be assessed by comparison to the oxygen saturation measurements~     from a laboratory blood gas analyzer.~   "
33757|NCT03124966|"~     In this study, the concentration of hemoglobin within the subject's blood will be reduced in~     a controlled manner by administering fluids intravenously. The accuracy of a noninvasive~     hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a~     laboratory analyzer.~   "
33758|NCT03124927|"~     In this study, the level of methemoglobin (HbMet) will be increased in a controlled manner by~     administering sodium nitrite intravenously in healthy volunteers. The accuracy of a~     noninvasive HbMet measurement by a DCI pulse oximeter sensor will be assessed by comparison~     to blood measurements from a laboratory analyzer.~   "
33777|NCT03124563|"~     The study goal is to design an intervention utilizing implementation intentions to help~     participants prospectively plan and visualize ways to increase activity for the next day~     among working adults who do not currently exercise or use an activity monitor. Investigators~     will assess the level of and changes in physical activity, and how this relates to various~     individual factors that are related to exercise and health, including self-efficacy, control~     beliefs, and cognition.~   "
33863|NCT03123393|"~     The purpose of this study is to assess the efficacy of TAK-659 measured by independent~     radiologic review committee (IRC)-assessed overall response rate (ORR) in participants with~     relapsed or refractory DLBCL.~   "
33864|NCT03123367|"~     Evaluation of the Nella Women's Care Line~   "
33759|NCT03124914|"~     Fatigue is a common symptom in people living with HIV (PHAs) that affects all aspects of life~     . This would include physical deconditioning, a reduction in motor skills . Numerous studies~     show that physical activity brings benefits for the quality of life of PHAs . However, due to~     the predominantly reported fatigue, many PHAs are not physically active enough in relation to~     these recommendations. While it is recognized that fatigue is predominant in PHAs, this~     complaint has mainly been subjectively quantified and has rarely been physically objectified~     a better understanding of the relationship between neuromuscular fatigue, perceived fatigue~     and the level of physical activity of PHAs is needed in line with current work on integrating~     fatigue.~      OBJECTIVES This project, based on an integrative (eg, neurophysiological and psychological)~     approach to fatigue, aims to better explain and prevent the vicious circle of physical~     deconditioning in PHAs by examining the relationships between neuromuscular fatigue,~     perceived fatigue, Physical activity of patients.~      The main objective of the study will be to compare the characteristics of neuromuscular~     fatigue in physically active or inactive PHAs.~      The secondary objective will be to examine the relationship between neuromuscular fatigue,~     level of physical activity and perceived physical fatigue of PHAs.~      CONDUCT OF THE STUDY Cross-sectional comparative study without individual benefit for the~     patient. Monocentric test to quantify and relate neuromuscular fatigue, perceived physical~     fatigue, and physical activity level. The main inclusion criteria for this study are: PLHIV~     aged between 40 and 60; Diagnosed and treated with antivirals after 1996, irrespective of the~     value of the viral load and CD4 lymphocyte level at the last assessment; The physical~     activity level of the patients will be evaluated before the start of the study in order to~     constitute two distinct groups~        -  Principal evaluation criterion: Investigation of the neurophysiological characteristics~          of fatigue will be done by recording the capacity to produce force at the level of the~          extensor muscles of the knee under conditions of voluntary contractions and evoked by~          magnetic stimulation at the level of Femoral nerve.~        -  Secondary evaluation criteria: the investigation of the perceived fatigue will be done~          by a valid psychometric questionnaire.~   "
33760|NCT03124901|"~     In this study, the concentration of hemoglobin within the subject's blood is affected by~     fluid status changes. The fluid status is affected by fluid loss during surgery for~     hospitalized study subjects or controlled administration of fluids intravenously for healthy~     study volunteers. The accuracy of a noninvasive hemoglobin sensor(s) will be assessed by~     comparing with blood sample analysis.~   "
33761|NCT03124875|"~     This pilot study will investigate the safety, effectiveness and feasibility of the LimFlow~     Stent Graft System for creating an AV fistula in the Below The Knee (BTK) vascular system~     using an endovascular, minimally invasive approach for the treatment of Critical Limb~     Ischemia (CLI) in subjects ineligible for conventional endovascular or surgical limb salvage~     procedures.~   "
33762|NCT03124836|"~     In this study, the level of methemoglobin (HbMet) will be increased in a controlled manner by~     administering sodium nitrite intravenously in healthy volunteers. The accuracy of the~     noninvasive HbMet measurement by a Pulse Oximeter Sensor will be assessed by comparison to~     blood measurements from a laboratory analyzer.~   "
33763|NCT03124823|"~     In this study, the level of oxygen within the blood will be reduced in a controlled manner by~     reducing the concentration of oxygen the study volunteer breathes. The accuracy of a~     noninvasive pulse oximeter sensor will be assessed by comparison to the oxygen saturation~     measurements from a laboratory blood gas analyzer.~   "
33764|NCT03124797|"~     In this study, the level of oxygen within the blood will be reduced in a controlled manner by~     reducing the concentration of oxygen the study volunteer breathes. The accuracy of a~     noninvasive pulse oximeter sensor will be assessed by comparison to the oxygen saturation~     measurements from a laboratory blood gas analyzer.~   "
33765|NCT03124784|"~     In this study, the level of oxygen within the blood will be reduced in a controlled manner by~     reducing the concentration of oxygen the study volunteer breathes. The accuracy of a~     noninvasive pulse oximeter sensor under motion conditions will be assessed by comparison to~     the oxygen saturation measurements from a laboratory blood gas analyzer.~   "
33766|NCT03124771|"~     In this study, the concentration of hemoglobin within the subject's blood will be reduced in~     a controlled manner by administering fluids intravenously. The accuracy of a noninvasive~     hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a~     laboratory analyzer.~   "
33767|NCT03124758|"~     In this study, the accuracy of a noninvasive hemoglobin sensor(s) will be assessed by~     comparison to hemoglobin measurements from a laboratory hematology analyzer. Blood samples~     are collected from healthy volunteers who are enrolled in either a blood draw procedure or a~     hemodilution procedure wherein blood is repeatedly sampled as the concentration of hemoglobin~     is reduced in a controlled manner by administering fluids intravenously.~   "
33768|NCT03124693|"~     In this study, the concentration of hemoglobin within the subject's blood is affected by~     fluid status changes. The fluid status is affected by fluid loss during surgery for~     hospitalized study subjects or controlled administration of fluids intravenously for healthy~     study volunteers. The accuracy of a noninvasive hemoglobin sensor(s) will be assessed by~     comparing with blood sample analysis.~   "
33769|NCT03124680|"~     Anaesthesia has three major components, analgesia, muscle relaxation and hypnosis.~      For a long time, opioids have been covering the analgesia function. (1) When using opioids,~     an analgesic effect is obtained per-operatively, however, not without side-effects.~     Post-operative complications such as: respiratory depression, post-operative nausea and~     vomiting, pruritus, acute opioid tolerance and hyperalgesia, difficulty voiding and ileus,~     are well known.~      Opioid usage is an important risk factor of postoperative desaturation. Postoperative~     desaturation can lead to severe hypoxemia and even tissue hypoxia, followed by obvious~     cardiologic and neurological complications.~      Thus, in patients at risk, such as the obese patient, experts suggest reducing opioid usage.~      Non-opiate protocols implemented on the obese patient have been published. Non-opiate~     protocols have been established using a combination of ketamine, lidocaine and an alpha-2~     agonist.~      The main purpose of this pilot study is to evaluate whether patients undergoing an opioid~     free anaesthesia regime experience less desaturation episodes during the first 24 h~     post-bariatric surgery than patients having received an opioid anaesthesia regime.~   "
33778|NCT03124550|"~     The study goal is to design and build an exergame to increase physical activity and social~     connections for Alzheimer's Disease (AD) caregivers using participatory design methods. AD~     caregivers will contribute extensively to the design and development of the content and~     motivational components of the exergame. The investigators will evaluate user experience with~     the exergame and the feasibility of using it to increase physical activity, exercise~     self-efficacy, and social connections among AD caregivers.~   "
33779|NCT03124537|"~     The goal of this study is to develop a smart phone/tablet app to administer a behavior change~     program that helps adults to increase daily steps by planning where, when, and with whom to~     walk. The investigators will test the effectiveness of various components of the walking~     program app for increasing the number of daily steps among sedentary older adults. The~     investigators also will examine the effects on self-efficacy and social integration/support.~   "
33770|NCT03124667|"~     The purpose of this double-blinded, randomized controlled study is to compare CORTEX~     (Cognitive Regulation Training and Exercise), a multi-faceted, center- and home-delivered—~     general and exercise-specific—active and traditional computerized cognitive training (CT)~     program to an attention-control condition involving health and wellness informational videos.~     More specifically, the cognitive training group will emphasize dual-task abilities, working~     memory, and visual-spatial processing, as well as self-as-exerciser priming and~     self-certainty training. It is hypothesized that early intervention cognitive training will~     enhance use of self-regulatory strategies and self-efficacy and in turn, increase exercise~     adherence to and engagement in a 12-month aerobic and resistive exercise program at a local~     fitness facility. More positive improvements in cognitive and psychosocial functioning among~     participants in the CORTEX condition (relative to the Video Attention-Control condition,~     i.e., health educational videos), are also expected immediately following the cognitive~     training, and across time. Expectancies and knowledge of study purpose (blinding integrity)~     will also be measured and used to statistically adjust for any training differences.~   "
33771|NCT03124654|"~     Pharmacists are in the best position to counsel and educate patients on anticoagulant agents~     such as NOACs. This should enable patients to play a more active role in their treatment and~     ultimately enhance adherence behaviour. However, educational elements should be targeted to~     knowledge. Thus, the investigators will develop and validate a questionnaire that can assess~     knowledge about NOACs~   "
33772|NCT03124641|"~     The purpose of this study is to test the effects of hypothermic oxygenated machine perfusion~     (HOPE) in a phase-II prospective multicenter randomized clinical trial (RCT) on extended~     criteria donor allografts (ECD) in donation after brain death (DBD) orthotropic~     liver-transplantation (OLT) (HOPE-ECD-DBD). Human whole organ liver grafts will be submitted~     to 1-2 hours of HOPE via the portal vein directly before implantation and going to be~     compared to a control-group of patients transplanted after conventional cold storage (CCS).~     Primary (early graft injury) and secondary (e.g. postoperative complications, hospital stay,~     survival) objectives are going to be analysed in a 12 month follow up. Ischemia-reperfusion~     (I/R) injury and inflammation will be assessed using liver tissue, serum and bile samples as~     well as machine perfusion perfusate.~      To improve the availability of donor allografts and reduce waiting list mortality, graft~     acceptance criteria were extended increasingly over the decades. The use of extended criteria~     donor (ECD) allografts is associated with higher incidences of primary graft non-function~     (PNF) and/or delayed graft function (DGF). As such, several strategies have been developed~     aiming at reconditioning poor quality ECD grafts. HOPE has been tested intensively in~     pre-clinical animal experiments. Although, its known that HOPE can exert its reconditioning~     effect via cellular and mitochondrial pathways in the endothelial and parenchymal cells,~     there is still scarce evidence available on the exact subcellular mechanism of HOPE induced~     organ protection in the clinical scenario of liver transplantation. In donation after cardiac~     death (DCD) OLT, the positive effects of HOPE have been shown to reduce the incidence of~     biliary complications, mitochondrial damage and improve the overall cellular energy-status.~      In the HOPE setting, organ perfusion is performed in the transplant center shortly before the~     actual implantation with oxygenated perfusate using an extra corporal organ perfusion system.~     The first clinical study with this promising technique was recently reported in a Swiss~     cohort of patients who received DCD allografts. In organ donation after brain death (DBD),~     the only legally accepted approach for organ donation in most countries, HOPE and its effect~     on early graft injury and postoperative complications remains to be elucidated.~   "
33773|NCT03124628|"~     The main purpose of this project is to improve physical function and muscle health in~     teenagers and young adults with cerebral palsy (CP) by using an eccentric-overload resistance~     exercise model~      Specific aims~        1. To compare the efficacy of eccentric-overload vs. weight stack resistance exercise in~          inducing muscle, functional and gait performance adaptations in teenagers with CP.~        2. To increase force, power and muscle mass in the lower limbs of patients with cerebral~          palsy.~        3. To improve gross motor function, balance and gait through eccentric-overload resistance~          exercise in teenagers suffering from cerebral palsy.~      We hypothesize that the time-effective flywheel resistance exercise paradigm will result in~     greater gains in muscle mass and function in teenagers with CP, when compared with~     conventional weight-stack technology. Importantly, we believe these adaptations will be~     translated into enhanced gross motor function, balance and gait performance.~      Forty teenagers and young adults (age range 16-23 yr) with spastic CP will be recruited. They~     will be randomly assigned to flywheel (FL; n=20) or weight-stack (WS; n=20) resistance~     exercise. During 8 weeks, all the teenagers will follow a standard resistance exercise~     training program within the Stockholm Habilitation Center system. In addition, patients will~     perform either flywheel (FL group) or conventional (WS group) leg press resistance exercise~     twice per week. Muscle force, power and activity (electromyography; EMG), leg extension lag,~     co-contraction, balance, functional mobility, gait quality, and muscle and fat thickness of~     lower extremities are assessed in all patients before and after the 8-week intervention (Fig.~     1).~   "
33774|NCT03124615|"~     The primary purpose of this trial is to determine whether dose reduction of enzalutamide in~     patients with grade 3 fatigue and/or cognition change will lead to an improvement in symptoms~     while maintaining active drug levels.~      Patients within 3 months of starting enzalutamide will be assessed by their oncologist as~     being potentially eligible for dose reduction due to the onset of moderate to severe fatigue~     and/or cognition change, which is assessed as being due to enzalutamide~   "
33775|NCT03124589|"~     Online interventions for gambling problems hold a strong potential to help people with~     gambling concerns. However, there are no trials, to-date, that have been able to demonstrate~     the effectiveness of such an intervention. The current trial will compare participants~     provided access to an online gambling intervention to those assigned by chance to a no~     intervention condition in order to test the efficacy of one such Internet intervention for~     gambling.~      Participants will be recruited through Amazon's MTurk crowdsourcing platform. Potential~     participants identified as problem gamblers who are interested in quitting or reducing their~     gambling in the next 6 months, or often think about it, based on an initial survey will be~     invited to complete additional surveys at 6 weeks and 6 months. Those who then agree to be~     followed up will be randomized to access an online intervention for gambling or a~     no-intervention website. These participants will then be contacted again at 6 weeks and 6~     months to ask about their gambling, and their impressions of the online intervention. The~     primary hypothesis to be tested is that participants receiving access to the online gambling~     intervention will report a greater reduction in number of days gambling and in NODS scores at~     6-month follow-up than participants in the no intervention control condition.~   "
33776|NCT03124576|"~     In the proposed study the investigators aim to clarify the relative contribution of these~     different mechanisms to the progression of AF. Also the contribution of the individual~     genetic background will be investigated. Furthermore, the investigators aim to identify~     clinical parameters and biomarkers informing on the main mechanisms of AF progression in~     atrial tissue.~      For this purpose, in all included patients atrial biopsies will be taken during cardiac~     surgery.~   "
33780|NCT03124524|"~     Our aim is to evaluate and compare the pain relief of estradiol valerate/dienogest and~     ethinylestradiol/ drospirenone by using doppler indices.~      100 nullipara patients with symptoms of severe primary dysmenorrhea (PD) requesting~     contraception aged from 18 to 35 were included to the study. Visual analog scale (VAS), the~     uterine artery doppler indices including systole/diastole rates ( S/D), pulsatility index~     (PI) and resistance index (RI) values were evaluated and recorded in both uterine vessels~     before treatment. The 66 PD patients who met the inclusion criteria were divided into 2~     groups and 33 healthy controls created Group 1. Group 2 were administered estradiol~     valerate/dienogest while Group 3 were administered 0.03 mg ethinylestradiol and 3 mg~     drospirenone. Both VAS scores and doppler indices were repeated after 3 months treatment. The~     changes in values were recorded.~   "
33781|NCT03124511|"~     To understand pain pathophysiology in terms of risk factors and protective mechanisms ranging~     from molecular pathways to societal impacts.~   "
33782|NCT03124498|"~     A Phase I/II, Open Label Study to Evaluate the Safety and Efficacy of Autologous~     Cytokine-Induced Killer (CIK) Cell for Patients with Hepatocellular Carcinoma (HCC) after~     Transarterial Chemoembolization (TACE), Percutaneous Ethanol Injection Therapy (PEIT) or~     RadioFrequency Ablation (RFA) Therapy.~   "
33783|NCT03124485|"~     Obesity and its related metabolic disorders are increasingly a heavy health burden to many~     parts of the world. Weight control is a well-known important step in avoiding type 2 diabetes~     mellitus (T2DM). It is also an essential component for normalizing the blood glucose and~     preventing macrovascular and microvascular insults to patients with diagnosed T2DM. However,~     life-style modification, physical exercise and dietary adjustment are ineffective measures~     which are unlikely to confer adequate and sustainable weight loss for the truly obese. On the~     other hand, large scale long-term follow-up studies have confirmed the role of bariatric~     surgery in providing durable weight loss and remarkable improvement on medical comorbidities.~     Among all the bariatric operations, laparoscopic sleeve gastrectomy (LSG) is currently the~     most widely adopted procedure worldwide because of its simplicity and effectiveness in weight~     reduction. However, LSG is not without risk. Staple-line hemorrhage, leakage and stenosis are~     potentially life-threatening complications. LSG is also costly because of the need for~     expensive laparoscopic staplers.~   "
33784|NCT03124472|"~     Pfannenstiel incision of skin and opening of the anterior abdominal wall in layers.~        -  The loose peritoneum of the lower uterine segment is dissected downwards to mobilize the~          urinary bladder and expose the lower uterine segment.~        -  Uterine artery ligation was performed by grasping the broad ligament with thumb anterior~          and the index finger lifting the base below the site uterine incision; the uterine~          artery was singly ligated with No. 1 vicryl suture. Myometrium was included so that~          uterine vessels are not damaged.~        -  Cresenteric lower uterine segment incision was performed as usual. Higher incisions were~          performed in cases where the traditional incision was expected to be directly through~          the placenta Delivery of the baby and placenta.~        -  Closure of the uterine incision in 2 layers with N0. 1 vicryl suture.~        -  Closure of the anterior abdominal wall in layers~   "
33785|NCT03124459|"~     This is a multicenter, phase 2 study to evaluate the safety, tolerability, pharmacodynamics~     (PD), efficacy, and pharmacokinetics (PK) of ACE-083 in patients with CMT1 and CMTX, to be~     conducted in two parts. Part 1 is non-randomized, open-label, dose-escalation and Part 2 is~     randomized, double-blind, and placebo-controlled.~   "
33786|NCT03124446|"~     Mindfulness interventions are increasingly offered to undergraduate students at universities~     world-wide, however the evidence base is very limited. The objective is to evaluate effects~     of a customized mindfulness intervention (called Mindfulness-Based College) on undergraduate~     student health. A superiority randomized controlled trial with parallel groups will be~     performed with 30 participants in each arm. Participants will be randomly assigned to~     Mindfulness-Based College or health education waitlist control. Investigators will be blinded~     to treatment allocation. Participants will be assessed at baseline, 10 weeks, and six months.~     The primary outcome is a college health summary score, including seven evidence-based~     determinants of health particularly relevant to college student well-being: body mass index,~     physical activity, diet, alcohol consumption, sleep quantity, perceived stress, and~     loneliness. Primary intention-to-treat analyses will evaluate whether MB-College vs. control~     is associated with the summary score, utilizing generalized linear models. Secondary analyses~     will evaluate which, if any, of the seven determinants of health are driving associations.~   "
33787|NCT03124433|"~     This is an investigator-initiated phase II single arm trial, combining neoadjuvant~     apalutamide (ARN509) with radical prostatectomy, in the treatment of D'Amico intermediate to~     high risk organ-confined prostate cancer. Apalutamide has shown efficacy in castrate~     resistant prostate cancer in phase II studies and are now in phase III trials combined with~     radiation in organ confined disease.~      The primary study objectives include assessment of (i) oncological efficacy as determined by~     tumour downstaging and achievement of nadir PSA The secondary study objectives include(i)~     determination of adverse effects related to apalutamide and surgical complication rates (ii)~     human prostate tissue effect of apalutamide~      The study will recruit thirty eligible participants who will receive 12 weeks of oral~     apalutamide 240mg daily. This will be followed by standard-of-care radical prostatectomy. The~     total trial duration is 26 weeks.~   "
33796|NCT03124303|"~     The IPOD-B3 study aims to characterize the relationship between premorbid brain activity and~     postoperative delirium in patients undergoing major surgery. This is a expansion of the~     NeuroVISION Bolt-On study, NCT01980511.~   "
33797|NCT03124290|"~     The investigators plan to investigate the effect of attention distractor on the quality of~     chest compression during cardiopulmonary resuscitation. For this, a simulated study with~     Manikin is performed and the paced auditory serial addition test (PASAT) is used for~     distracting performer's attention.~   "
33798|NCT03124277|"~     This randomized, trial will tested the hypothesis that nutritional supplementation with whey~     protein, essential amino acids - mainly leucine - vitamin D and calcium would increase the~     efficacy of physical rehabilitation in old adults suffering from Parkinson's disease o~     parkinsonism~   "
33865|NCT03123354|"~     The study will collect cerebral oximetry data from pediatric and neonatal subjects using the~     Masimo O3 regional oximetry device, for the purposes of device calibration and validation.~   "
33866|NCT03123328|"~     This is a prospective, non-blinded, non-randomized, interventional study of the Masimo pulse~     oximeter and sensors in a trauma setting.~   "
33788|NCT03124420|"~     Helicobacter pylori (H. pylori) is the most common chronic bacterial infection in humans.~      The prevalence of H. pylori is about 30~50% in the Western adult population. It is estimated~     that about 50% of people are infected with this bacterium in Taiwan. Many studies have shown~     that H. pylori is an important causal factor of chronic gastritis, peptic ulcer disease,~     gastric cancer and gastric lymphoma. The World Health Organization classified H. pylori as a~     Group 1 carcinogen in 1994. Endoscopic examination is indicated to confirm the above~     diagnosis for patient with H. pylori infection. Eradication of H. pylori infection reduces~     the risk of gastric cancer and recurrence of peptic ulcer disease. However, the eradication~     rate of clarithromycin-based triple therapy has been declining in recent years, probably~     related to the increasing resistant rate to clarithromycin. Several strategies have been~     proposed to overcome the declining eradication rate, including (1) extending the treatment~     duration of triple therapy to 14 days; (2) the use of bismuth quadruple therapy which~     contains bismuth, a proton pump inhibitor, and two antibiotics (usually metronidazole and~     tetracycline); (3) non-bismuth quadruple therapy (concomitant therapy) which contains a~     proton pump inhibitor and three antibiotics (usually amoxicillin, metronidazole, and~     clarithromycin); (4) sequential therapy which contains a proton pump inhibitor (PPI) plus~     amoxicillin for five days, followed by a PPI plus clarithromycin and tinidazole for another~     five days. The investigators aim to improve the eradication rate of H. pylori infection while~     an endoscopic examination is performed.~   "
33789|NCT03124407|"~     This is a study of a OTC TFM compliant, capsaicin-based (0.25%) topical analgesic for~     management of osteoarthritis (OA) knee pain (OAKP). Subjects meeting the inclusion criteria~     and not meeting the exclusion criteria will be randomized into one of four groups: once daily~     treatment with active product, once daily treatment with product vehicle (no capsaicin),~     twice daily treatment with active product, and twice daily treatment with product vehicle (no~     capsaicin), all for 7 consecutive days of treatment. The twice daily treatments are spaced~     approximately 12 hrs apart. OAKP is assessed by the 100 mm VAS scale. OAKP assessments are~     done each day for 28 days. Tolerability data are also collected.~   "
33790|NCT03124394|"~     Evaluation of clinical outcome and economical aspects in the treatment of patients with~     peritoneal carcinomatosis.~   "
33791|NCT03124368|"~     The primary objective of this study is to determine whether ACH-0144471 can increase blood C3~     levels in participants with low C3 levels due to either C3G or IC-MPGN.~   "
33792|NCT03124355|"~     The purpose of this study is to investigate how the electrical stimulation of a nerve in the~     skin of the earlobe (transcutaneous vagal nerve stimulation), alone or in combination with~     two medications (galantamine and pyridostigmine), affects the way the autonomic (involuntary)~     nervous system controls heart rhythm, symptoms on standing, and inflammatory markers in~     female patients with postural tachycardia syndrome (POTS). The study consists of 2 parts: a~     screening (1-2 study days), and 3 testing days. The study will take 5 days total and about 16~     participants will be screened for the study. The investigators estimate 13 will be eligible~     to participate in all of the study days.~   "
33793|NCT03124342|"~     Every year, millions of Americans are admitted to the intensive care unit. Due to advances in~     critical care, mortality rates are decreasing, increasing the number of ICU survivors.~     Survivors of critical illness, however, often face physical, functional, and cognitive~     deficits that place them at risk for a cycle of re-hospitalization that frequently culminates~     in premature death. Moreover, post-ICU interventions may be resource-intensive and may be~     most cost-effective only in a subgroup of patients at highest risk. Whether a~     multi-disciplinary program to facilitate recovery from critical illness can prevent hospital~     readmission and improve quality of life among high-risk ICU survivors remains unknown. The~     primary aim of this pilot is to examine the feasibility of implementing a multidisciplinary~     ICU Recovery Program and the influence of such a program on process measures including~     contact with the ICU recovery team and attendance of ICU recovery clinic. The secondary aims~     are to compare the effect of an ICU Recovery Program on 30-day same-hospital readmission and~     other clinical outcomes.~   "
33794|NCT03124329|"~     Rationale: Treatment of gingival recession defects requires coronal advancement of the~     gingival margin due to patient esthetic demand, tooth sensitivity and improvement of tooth~     prognosis, which can be accomplished either through a flap procedure or through a tunnel. It~     will be desirable to determine the efficacy of Vestibular Incision Subperiosteal Tunnel~     Access (VISTA) to Coronally Advanced Flap (CAF) procedure and intrasulcular tunneling.~      Another aspect of the study is to determine whether autologous concentrate of platelets and~     leukocytes (leukocyte-platelet-rich fibrin; L-PRF) has equivalent efficacy to connective~     tissue autologous graft harvested from the palate.~      The overall objective of this study is to evaluate the effectiveness of therapeutic~     modalities for the treatment of multiple gingival recession defects.~      The study is designed as a prospective, randomized controlled clinical trial. Four groups~     will be compared:~      Group 1: Coronally Advanced Flap (CAF) Group 2: VISTA Group 3: Intrasulcular tunneling (IST)~     Group 4: VISTA + L-PRF~      Each of the groups will be treated without any graft material in order to examine the~     efficacy of coronal advancement and periodontal root coverage without the confounding~     variable of graft material. These techniques don't require any additional graft if there is~     adequate amount of keratinized gingiva~      The study population will be patients who present to Advanced Graduate Program in~     Periodontology at the University of Southern California, USA, and are deemed to require~     treatment of multiple gingival recession defects. A total sample of 100 participants (23~     participants per group) will provide a two sided test of means with 80% power at alpha of~     0.05. The calculation was carried out using PASS Version 12 (Hintze, J. (2014). NCSS, LLC.~     Kaysville, Utah.)~      The study duration will be 1 year. Follow-up visits after the surgery will occur after 3 days~     , 7 days and at weeks 3, 6, 12, 24, 36 and 52. These follow up visits consistent with~     standard of care follow up for gingival recession treatment and there will be no additional~     costs to the participant.~      The Primary Outcome variable is complete root coverage; the Secondary Outcome Variables are~     clinical attachment level (CAL) gain, changes in gingival thickness and volume and the~     Tertiary Outcomes are aesthetic outcomes, postoperative pain and Patient satisfaction survey~   "
33795|NCT03124316|"~     Family doctors can play a critical role in successfully arranging cancer screening tests to~     occur, especially if they know which patients are due for these tests. However, they don't~     always interact with or take advantage of registry data to this end. For example, in Ontario,~     the Screening Activity Report provides exactly this information to family doctors, helping~     them identify their patients who are overdue for screening. Unfortunately, less than half of~     family doctors regularly use the Screening Activity Report even though they get monthly email~     reminders. One possible reason is that the reminders they receive are not designed to compel~     action. They are easy for family doctors to miss or dismiss. This study will compare multiple~     different ways of designing the reminders. The different versions of the email are tested in~     a 2^3 factorial trial testing three behaviour change techniques to see which ones will lead~     to more family physicians interacting with the Screening Activity Report and at increasing~     the number of patients that get all the appropriate screening tests for cervical, breast,~     and/or colon cancer.~   "
33799|NCT03124238|"~     The main objective of the current proposal is to investigate the clinical and physiological~     changes triggered by massage therapy in a group of individuals with chronic low back pain~     experiencing muscular fatigue.~      The investigators believe these objectives are in line with the 2014 Massage Therapy~     Research Fund research priorities, since the results produced by these investigations will~     generate knowledge with regard to the short term clinical efficacy of massage therapy and~     will provide critical information related to the physiological mechanisms underlying massage~     therapy clinical effects. Most importantly, the combined assessment of clinical and~     physiological outcomes will also yield key information to identify specific biological~     components of the massage therapy intervention. Determining the presence of a biological~     mechanism is, as for any treatment, considered one of the necessary criteria to declare a~     causal relationship between a specific intervention and its associated clinical effects. The~     investigators strongly believe that the proposed research will contribute to the~     identification of specific mechanisms that will complement the emerging clinical evidence~     supporting massage therapy in the treatment of chronic low back pain.~      The proposed research project will involve researchers and future practitioners of massage~     therapy. In conjunction with a high quality research environment, it is the goal of the~     investigators to create an educational environment for undergraduate and graduate students~     that will foster interdisciplinary collaboration in order to ensure a diversified; high~     quality training of young researchers and clinician scientists working in the field of manual~     therapies.~   "
33800|NCT03124225|"~     The aim of this research study is to describe the impact of rheumatologist performed~     ultrasound on the diagnosis and management pathways of patients with rheumatoid arthritis.~     Primarily, to compare the time from first visit to treatment initiation between patients with~     and without rheumatologist-performed ultrasound assessment.~   "
33801|NCT03124212|"~     Breast, colorectal, ovarian, and endometrial cancers constitute approximately 30% of newly~     diagnosed cancer cases in Switzerland and affect more than 12,000 individuals annually.~     Several hundred of these patients are likely to carry known genetic mutations associated with~     HBOC or LS. Genetic testing for hereditary susceptibility to cancer can prevent many cancer~     deaths through early identification and engagement in high-risk management care that involves~     intensive surveillance, chemoprevention and/or prophylactic surgery. However, current rates~     of genetic testing indicate that many Swiss mutation carriers and their family members do not~     use cancer genetic services (counseling and/or testing), either due to lack of coordination~     of care or due to lack of communication about the mutation among family members.~      Cascade screening identifies and tests family members of a known mutation carrier. It~     determines whether asymptomatic family members are carriers of the identified mutation and~     proposes management options to reduce harmful outcomes. Robust evidence of basic science and~     descriptive population-based studies in Switzerland support the necessity of cascade~     screening for HBOC and LS. However, translation of this knowledge into public health~     interventions is lacking.~      Specific Aims of the CASCADE study are:~        1. Survey Index Patients diagnosed with HBOC or LS from clinic-based genetic testing~          records and determine their cancer status and surveillance practices; needs for~          coordination of medical care; psychosocial needs; patient-provider and patient-family~          communication needs; quality of life; willingness to serve as advocates for cancer~          genetic services for blood relatives.~        2. Survey first- and second-degree relatives, and first cousins identified from pedigrees~          and/or family history records of HBOC and LS Index Patients and determine their cancer~          and mutation status; cancer surveillance practices; needs for coordination of medical~          care; barriers and facilitators to using cancer genetic services; psychosocial needs;~          patient-provider and patient-family communication needs; quality of life; willingness to~          participate in a study designed to increase use of cancer genetic services.~        3. Explore the influence of patient-provider communication about genetic cancer risk on~          patient-family communication and the acceptability of a family-based communication,~          coping, and decision support intervention with focus group(s) of mutation carriers and~          blood relatives.~   "
33802|NCT03124199|"~     Background: A progressive decrease in Helicobacter pylori eradication rates has been~     described over the years, so new combinations of antibiotics for treatment are needed.~      Aim: To evaluate the efficacy and safety of the addition of rifaximin to standard triple~     therapy (omeprazole, amoxicillin and clarithromycin) for the eradication of H. pylori.~      Methods: Independent prospective pilot clinical trial (EUDRA CT: 2013-001080-23). Forty~     consecutive adult patients were included with H. pylori infection, dyspeptic symptoms and~     naive to eradication treatment. A full blood test was performed in the first 5 patients~     included to evaluate the safety of the treatment. H. pylori eradication was confirmed with~     urea breath test at least 4 weeks after the end of treatment. Treatment: Rifaximin 400 mg/8~     h, clarithromycin 500 mg/12 h, amoxicillin 1 g/12 h, and omeprazole 20 mg/12 h for 10 days.~   "
33803|NCT03124186|"~     This research project addresses a scientifically important question that cannot be answered~     by other means. The use of peripheral nerve stimulation has the potential to enhance recovery~     in subacute stroke patients with poor functional recovery. The primary objective of this~     proposal is to demonstrate that peripheral nerve stimulation combined with intensive motor~     training has the ability to further improve hand motor function when compared to intensive~     training alone or nerve stimulation alone. The results from this study have the potential to~     develop new strategies in neurorehabilitation.~   "
33804|NCT03124173|"~     The cognitive control of speech is central to human social communication. Two frontal brain~     regions seem to have a critical role: 1) Broca's area (BA) and 2) the mid-cingulate cortex~     (MCC). Current rehabilitation strategy is clearly based on therapies promoting language~     performance. However, there is few evidence that rehabilitation strategies based on~     nonlinguistic aspects of brain function may enhance recovery. Such strategies may benefit~     from knowledge about the primary -nonlinguistic- function of the BA-MCC network. The aim of~     LANGUAGE is to identify this primary function. One hypothesis is that, in non-speaking~     primates, this network is involved in cognitive control of voluntary vocal/orofacial~     production. Specifically, whereas BA may be responsible for the high-level selection of~     orofacial and vocal responses during learning, the face motor representation within the MCC~     may be responsible for performance monitoring, a process inherently required in learning.~     LANGUAGE aims to test this hypothesis by determining in human the anatomo-functional~     organization of the BA-MCC network thanks to functional magnetic resonance imaging (fMRI).~   "
33805|NCT03124160|"~     This will be a multi-site, participant-blinded, randomized clinical trial. The investigators~     will randomize 1000 eligible participants in a 4:1 ratio to two different copper IUDs: 800 to~     Mona Lisa NT Cu380 Mini and 200 to ParaGard.~   "
33806|NCT03124147|"~     This study will compare the effectiveness of different polarities of transcranial direct~     current stimulation paired with intensive motor training in recovery of upper extremity~     function in individuals with severe post-stroke hemiparesis. The hypothesis is that more~     severely impaired individuals will derive greater benefit from anodal stimulation of the~     ipsilesional hemisphere or cathodal stimulation of the contralesional hemisphere than dual~     stimulation (anodal applied to the ipsilesional hemisphere and cathodal applied to the~     contralesional hemisphere.)~   "
33807|NCT03124134|"~     A study to determine glucose and insulin responses to 50g and 100 g of carbohydrate with and~     without Gelesis200.~   "
33808|NCT03124121|"~     The purpose of this study is to gain insight into the exposure-response relationship of~     golimumab in moderate-to-severe Ulcerative Colitis (UC).~      Patients commencing induction therapy with golimumab will be enrolled into a prospective~     study and evaluated at three time-points (weeks 6, 10 and 14) for clinical and biochemical UC~     disease activity as well as serum golimumab concentrations and the presence of anti-golimumab~     antibodies. Patients already established on stable golimumab maintenance therapy will be~     enrolled into a cross-sectional study with the same evaluations taken at a single time point.~   "
33809|NCT03124108|"~     The primary objective of the study is to compare the effect of daily oral administration of~     elafibranor 80mg and 120 mg on change in serum alkaline phosphatase (ALP) to that of placebo~     in patients with PBC and inadequate response to Ursodeoxycholic acid (UDCA).~   "
33810|NCT03124095|"~     The aim of the present study is analyze the effects of combined training program (resistance~     and aerobics) in comparison with a non-training group on quality of life, as well as on~     neuromuscular and cardiorespiratory parameters in breast cancer patients in stages one to~     three who have finished their treatment, such as surgery, chemotherapy and radiotherapy.~     Therefore, 42 women will be randomly divided into two groups: combined training group and~     control group. The subjects of the combined training group will undergo the intervention~     three times a week for eight weeks. The combined group will carry out both resistance and~     aerobic exercises in the same session. The resistance training will be comprised by ten~     exercises which will alternate body segments with maximum repetitions in the first set and~     the lower limit of the repetitions interval in the next sets. Along the training, the number~     of series will be increased whereas the number of repetitions will be decreased. The~     intensity of the aerobic exercises will be based on the percentage of the heart rate of the~     anaerobic threshold on the first weeks and on the speed of the anaerobic and aerobic~     threshold on the last weeks. Before and after the intervention, there will be evaluation of~     maximal dynamic strength of knee extensors and elbow flexors, maximum voluntary isometric~     contraction of knee extensors, maximum muscular activity of vastus lateralis and rectus~     femoris, muscle thickness of knee extensors, peak oxygen uptake and ventilatory threshold,~     quality of life and cancer-related fatigue. Data will be analyzed by Generalized Estimating~     Equations (GEE) and Bonferroni's post-hoc (α=0,05), including both protocol and intention to~     treat.~   "
33811|NCT03124082|"~     Opioids have been used for analgesia since many years, but despite potent analgesia they are~     also associated to side effects, including opioid induced Hyperalgesia (OIH).~      OIH in the surgical setting is debated, and may predispose patients to higher analgesic~     consumption in the preoperative period, and peripheral and central sensitization. The aim of~     the study is to compare remifentanil-based vs non opioid analgesia (clonidine, lidocaine,~     ketamine) for intraoperative management of patients undergoing laparoscopic left~     hemicolectomy, with the hypothesis that non- opiod treated patients will have lower morphine~     consumption in the first 24 hours after surgery. Peripheral and central hyperalgesia will be~     tested with Von Frey hairs and pin-prick to evaluate acute CNS (Central Nervous System)~     sensitization after surgery. Acute and persistent (1 and 3 months) pain will be registered,~     together with any side effect and parameters of surgical rehabilitation.~   "
33812|NCT03124056|"~     The aims of the study:~        1. To evaluate the clinical efficacy of the use of extracorporeal photopheresis in the~          treatment of Graft-versus-host disease under standard clinical indications as~          pre-defined by the participants Centers (members of the Spanish Group for Hematopoietic~          Transplantation).~        2. To explore and identify biomarkers of clinical response to extracorporeal photopheresis~          treatment of acute or chronic Graft-versus-host disease after Allogeneic hematopoietic~          stem cell transplantation~   "
33813|NCT03124043|"~     The objective of the Get In Touch - Phase 2 (GIT-2) study was to evaluate a diabetes care~     support intervention facilitated by cellular-enabled glucose meters in adults with persistent~     poor control of type 2 diabetes.~   "
33814|NCT03124030|"~     Direct Oral Anticoagulants were recently approved for medical treatment of several condition~     such as, non valvular atrial fibrillation, deep venous thrombosis, and others, substituting~     sometimes the conventional oral anticoagulants. The aim of the present study is to observe~     the possible difference in intra-operative and post-operative bleeding events for single~     dental extraction.~   "
33815|NCT03124017|"~     The investigators aim to investigate whether a computer-based alert system in the electronic~     patient chart and order entry system using the Geneva Risk Score as clinical decision support~     tool to estimate the risk of venous thromboembolism improves the rate of appropriate~     thromboprophylaxis among hospitalized medical patients.~   "
33816|NCT03124004|"~     Direct Oral Anticoagulants were recently approved for medical treatment of several condition~     such as, non valvular atrial fibrillation, deep venous thrombosis, and others, substituting~     sometimes the conventional oral anticoagulants. The aim of the present study is to observe~     the possible difference in intra-operative and post-operative bleeding events for periodontal~     debridement.~   "
33817|NCT03123991|"~     The current study proposes to extend transdiagnostic treatment research to adolescents by~     establishing initial pre to post-treatment and follow-up outcomes associated with the use of~     the Spanish Version of the Unified Protocol for the Treatment of Emotional Disorders in~     Adolescents (UP-A; Ehrenreich-May, Bilek, Buzzella, Kennedy, Mash, & Bennett, 2016) as a~     universal school-based preventive intervention.~   "
33818|NCT03123978|"~     This phase I trial studies the best dose and side effects of niclosamide when given together~     with enzalutamide in treating patients with castration-resistant prostate cancer that has~     come back or has spread to other places in the body. Androgens can cause the growth of~     prostate cancer cells. Hormone therapy using enzalutamide may fight prostate cancer by~     lowering the amount of androgen the body makes and/or blocking the use of androgen by the~     tumor cells. Niclosamide may block signals that enhance prostate cancer cell growth. Giving~     enzalutamide and niclosamide may work better in treating patients with castration-resistant~     prostate cancer.~   "
33819|NCT03123965|"~     This is an expanded access program (EAP) for eligible participants. This program is designed~     to provide access to glecaprevir/ pibrentasvir prior to approval by the local regulatory~     agency. Availability will depend on territory eligibility. Participating sites will be added~     as they apply for and are approved for the EAP. A medical doctor must decide whether the~     potential benefit outweighs the risk of receiving an investigational therapy based on the~     individual patient's medical history and program eligibility criteria.~   "
33820|NCT03123952|"~     This is an expanded access program (EAP) for eligible participants. This program is designed~     to provide access to ABT-414 prior to approval by the local regulatory agency. Availability~     will depend on territory eligibility. Participating sites will be added as they apply for and~     are approved for the EAP. A medical doctor must decide whether the potential benefit~     outweighs the risk of receiving an investigational therapy based on the individual patient's~     medical history and program eligibility criteria.~   "
33821|NCT03123939|"~     This is a single arm, open-label, multi-center, phase II study to determine the safety and~     efficacy of CTL019 in pediatric/young adult patients with r/r B-cell ALL.~   "
33822|NCT03123926|"~     The prediction of preterm birth is beneficial because it initiates early treatment to~     minimize risk. It defines a population at risk to provide particular treatment and may lead~     us to a better understanding the mechanisms of preterm birth. The understanding of the~     mechanisms and etiology consequently leads to the possibility of early intervention and~     effective management aiming at preventing preterm birth. Five most common interventions for~     preventing and treating preterm birth are antibiotics, cervical cerclage, bed rest,~     progesterone, and tocolytic therapy. However, there are insufficient evidence showing the~     efficacy of cerclage and bed rest; antibiotics may only delay but not prevent the preterm~     birth; the use of certain tocolytics needs to be considered against the possible adverse~     effects. The early detection of pregnant women with high risk for preterm delivery would be~     the ideal solution to prevent preterm birth. However, to date, there is inadequate literature~     and little knowledge of diagnosis, treatment, prevention and prediction of preterm birth.~   "
33823|NCT03123913|"~     The purpose of this study is to investigate the safety and tolerability of combination~     therapy with recombinant human growth hormone (rHGH) and testosterone in adult male patients~     with facioscapulohumeral muscular dystrophy (FSHD) over 24 weeks.~   "
33824|NCT03123900|"~     The MoveMent project applies non-pharmacological strategies - physical exercise and cognitive~     training - that have been shown to be effective in promoting active and healthy aging. The~     objective is to study the molecular and neural mechanisms of these strategies to stimulate~     brain plasticity and improve brain health and cognitive functioning.~   "
33825|NCT03123887|"~     Although the response rate by first-line treatment has been improved, most adult patients~     with relapsed or refractory ALL will eventually relapse with poor outcomes regardless of~     treatments. To further understand current status of the treatment of adult patients with~     relapsed or refractory ALL in China, the study retrospectively collected diagnosis and~     treatment data from ALL patients in 14 centers in China. Primary objective: to estimate the~     proportion of patients in overall response rate (ORR) for early relapsed or primary~     refractory Philadelphia chromosome negative (Ph-) B-precursor ALL patients following salvage~     treatment (i.e., proportion of patients in hematological complete remission [CR] and CR with~     partial recovery of blood cells [CRh*]); Secondary objectives included: to estimate the~     proportion of patients in CR, CRh* and CRi(CR/CRh*/CRi) and the duration of CR/CRh*/CRi,~     overall survival, duration of CR/CRh*and the proportion of patients receiving allogeneic~     hematopoietic stem cell transplantation (AlloHSCT) for early relapsed/primary refractory~     Ph-B-precursor ALL patients following salvage treatment; Exploratory objectives included: to~     estimate the efficacy in late relapsed Ph- B-precursor ALL (first remission duration > 12~     months) patients and in Ph+ B-precursor ALL patients and specific subgroup patients following~     salvage treatment.~   "
33826|NCT03123874|"~     The MiLC trial is a randomized control trial of two different types of breast pumps--mother's~     own and sterile. The objective of this trial is to investigate the bacterial composition of~     human milk pumped and stored in real-life conditions. To meet this objective, lactating~     mothers will fully express breast milk from one breast on two consecutive pumping sessions at~     home, once with the participant's own pumps and bottles and once with a sterile,~     hospital-grade pump and sterile bottles. Randomization will be used to determine which pump~     participants use first. From the total volume of milk pumped during each pumping session, the~     researchers will collect 1 oz. Milk from both pumps will be stored at home and sampled on~     days 0, 2, 4, and 30 after expression for analysis of its bacterial composition.~   "
33827|NCT03123861|"~     Purpose: To assess the impact of gabapentin versus placebo on overall postoperative pain and~     gluteal pain at 1 week post vaginal sacrospinous ligament suspension for apical pelvic organ~     prolapse.~      Participants: English-speaking women planning to undergo a vaginal SSLF. Concurrent~     procedures can be performed except total vaginal hysterectomy, colpocleisis, anal~     sphincteroplasty, fistula surgery, or urethral diverticulectomy~      Procedures (methods): Patients will be randomized to receive either 2 weeks of gabapentin or~     placebo for 2 weeks post-operatively. Standard of care pain medications will be given to both~     groups. Patients will be followed for 6 weeks post-operatively.~   "
33828|NCT03123848|"~     The purpose of the study is to evaluate the pharmacokinetic (PK) and safety of darunavir~     (DRV) and cobicistat (COBI) after a single oral administration of Prezcobix (DRV/COBI~     fixed-dose combination tablet) in healthy Japanese adult participants.~   "
33829|NCT03123835|"~     Evaluation of current and newly developed endoluminal therapies in the management of Upper~     and Lower GI conditions.~   "
33830|NCT03123822|"~     Recent studies have shown children who sustain a concussion are susceptible to having chronic~     symptoms (post-concussion syndrome). This chronicity can lead to delays in returning to learn~     and returning to play. Blurry vision, double vision, eye strain and eye tracking problems are~     some of the reported chronic symptoms that can affect patients' daily activities. Concussion~     awareness has increased recently and there is a surge of interest to better understand and~     treat the symptoms of post-concussion syndrome. Currently, ocular treatment for patients are~     often empirically determined. Common treatments are vision therapy and/or bifocal glasses.~     There has yet to be any standardization or prospective studies looking into treatment for~     these concussed patients with ocular symptoms and findings. The objective of this protocol is~     to compare three different types of glasses (typical prescription glasses for kids, typical~     glasses for kids with anti-glare coating, and progressive addition lenses with anti-glare~     coating) as treatment options for participants who are still symptomatic four weeks out from~     their concussion. The main outcome is the effectiveness of these three different options in~     reducing patients' symptoms and improving the participants' visual findings.~   "
33831|NCT03123809|"~     Gastroparesis (GP) is describing a condition when stomach does not empty as fast as it~     should. This fact creates the situation, when food stays in the stomach for a long time and~     it causes symptoms of nausea, vomiting, loss of appetite, bloating, inability to finish~     normal size meal and abdominal pain. There are not many drugs available to treat this~     condition and majority of gastroparetic patients are not responding well to them after they~     are on it for some time. Many investigators are able to implant Gastric Stimulator System~     (GES) under FDA approved status of Humanitarian Device Exemption (HDE) definition. In the~     last few years it became possible to add another surgical procedure, which is called~     pyloroplasty (making bigger opening on the end of stomach), may help even more as it is also~     increasing the rate of the emptying of the stomach. Therefore this study is proposing to~     evaluate if GES in combination with pyloroplasty is much better than pyloroplasty alone. For~     this reason, two of these procedures will be introduced surgically at the same time, but GES~     devices will not be turn ON in half of these participants for 3 months. After that time all~     subjects will have their devices turned ON. All subjects will be asked to evaluate their~     symptoms of gastroparesis and their quality of life during clinical visits, and investigators~     will conduct pathological analyses of tissue obtained during surgery.~   "
33832|NCT03123796|"~     Use of proton pump inhibitors (PPIs) is quite common among renal transplant recipients and~     reduced kidney functions and hypomagnesemia with the use of PPIs have been reported. In this~     study, investigation of the effects of PPI use on the outcome of kidney transplant recipients~     is aimed.~   "
33833|NCT03123783|"~     This study is a Phase 1-2 open-label dose escalation study of the immuno-activating~     monoclonal antibody APX005M administered in combination with nivolumab to adult subjects with~     non-small cell lung cancer or metastatic melanoma. The Phase 1 portion is intended to~     establish the maximum tolerated dose and the recommended phase 2 dose of APX005M when~     administered in combination with nivolumab. The Phase 2 portion of the study will evaluate~     safety and efficacy of the combination.~   "
33834|NCT03123770|"~     This is a multicentric, open-label,non-randomized concurrent control, 1:1~     match,non-inferiority trial that assesses the efficacy and safety of neoadjuvant chemotherapy~     regimen DC-T and EC-T in breast cancer patients.~   "
33835|NCT03123757|"~     This study evaluates the determinants of mobility, measured by the 6-minute walk test, and~     its correlation with quality of life in near elderly patients.~   "
33836|NCT03123744|"~     The investigational drug being tested in this study is palbociclib. Palbociclib is considered~     experimental because it is not approved by the FDA for the treatment of all cancers.~     Palbociclib is currently approved for use in breast cancer. Palbociclib is a drug belonging~     to a family of drugs called kinase inhibitors. These drugs slow or stop the activity of~     particular proteins involved in the growth of human cells and in the abnormal growth of~     cancer cells. Blocking these proteins may decrease or stop tumor growth. The purpose of this~     study is to assess the safety of the study drug, to see how well it is tolerated, and also to~     find a safe dose range of the study drug in patients with specific kinds of tumor genetic~     changes.~   "
33837|NCT03123731|"~     HIV is associated with a pattern of neurocognitive deficits, metabolic dysfunction, and an~     elevated risk for cardiovascular disease (CVD), phenomena that remain untreated despite the~     use of medications to control the disease. This proposal will examine the effect of a~     personalized, automated, interactive mobile phone text message intervention (iSTEP) designed~     to increase moderate physical activity (PA), decrease sedentary behavior (SB), and promote a~     healthy Mediterranean-style diet (MedDiet) in persons living with HIV (PLWH). The~     investigators propose that participants who receive the iSTEP intervention will increase the~     amount of physical activity, improve their diet, show a reduction in risk factors for CVD,~     and exhibit improved neurocognitive performance.~   "
33838|NCT03123718|"~     The outcome of patients with central nervous system (CNS) relapse in DLBCL is poor, with~     median survival times of 2-5 months. This fatal prognosis necessitates CNS prevention in a~     subgroup of patients with a high risk of CNS relapse.~      Intrathecal methotrexate (ITMTX) has traditionally been used, although its efficacy for CNS~     prophylaxis is contradictory. High-dose intravenous methotrexate (IVMTX) has been suggested~     as an alternative approach. Considering the lack of evidence supporting the role of ITMTX,~     the investigators propose to compare the efficacy of ITMTX and IVMTX for prophylaxis of CNS~     relapse in a subgroup of patients with DLBCL at a high risk for CNS relapse.~   "
33839|NCT03123705|"~     The prevalence of tooth decay and other oral disease are often overlooked indicators of~     overall public health. To improve the understanding of oral health in El Paso, the City of El~     Paso Health Department has teamed up with Texas Tech University Health Sciences Center El~     Paso in a collaborative effort to determine the factors that contribute to poor oral hygiene,~     and lead to cavities and periodontitis. The team will collect saliva, oral debris, leftover~     teeth and plaque from children and young adults to study oral infections, markers of~     inflammation, and other contributors to tooth decay and oral illnesses. Samples also will be~     stored for future investigations. This joint effort will provide a better picture of oral~     health in El Paso, and will define a framework for prevention, earlier diagnosis, and better~     treatment.~   "
33840|NCT03123692|"~     A pilot study to explore safety of the treatment with the antioxidant and metal chelator NBMI~     in COPD patients.~      Investigational product: NBMI ((N1,N3-bis(2-mercaptoethyl) isophthalamide), INN: Emeramide~      Indication: Mild, moderate and severe COPD with bronchitis~      A randomised, two arm, double-blind, placebo-controlled, cross-over, once daily for 14 days~     pilot study in subjects with COPD with bronchitis.~   "
33860|NCT03123432|"~     The survey is a phase IV, prospective randomized clinical trial to determine whether an~     immunomodulating nutrient-enriched diet compared to a standard diet can improve nutritional~     status and reduce postoperative infection and surgery-induced immune suppression in patients~     with gastric cancer or GIST undergoing major surgery in a single medical center.~   "
33861|NCT03123419|"~     The purpose of the Gardasil study is to increase the rates of Gardasil vaccination at a~     maternal fetal Care Center. This will be done by reminding patients via text to come for~     follow up vaccine appointments.~   "
33867|NCT03123315|"~     The purpose of this study is to improve the safety of surgery to remove a uterus (a~     hysterectomy) by better understanding where a patient's ureters lie.~   "
33841|NCT03123679|"~     Adult patients referred to radiotherapy treatment of primary or secondary malignant~     involvement of the lung parenchyma, who are not meeting the exclusion criteria, will be~     introduced to the study and suggested to participate in it by the radiotherapist, Dr~     Viacheslav Soyfer, M.D. from the Institute of Radiotherapy Tel Aviv (Sourasky) Medical~     Center.~      They will sign an informed consent and the study will be conducted based on the agreement of~     the institutional ethical committee, prior to perfusion study.~      Each patient will be evaluated three times: prior to treatment, a baseline evaluation~     mid-follow-up period 6 weeks post initiation of radiotherapy and a delayed follow up 6 months~     post treatment. Each SPECT/ Low dose CT assessment will take place within two weeks of the~     clinical and PFT assessment.~      The study will take place within a duration of two years, from recruiting the participating~     patients to the completion of the study protocol by the last recruited patient. For the~     individual patient, the duration of participation is six months.~      Perfusion SPECT/ Low dose CT studies with a non-diagnostic low dose chest CT will be~     performed after the I.V. injection of 4 mCi 99m-Tc-MAA. SPECT/ Low dose CT scan will be~     acquired immediately post injection on a GE OPTIMA NM/CT 640 camera. In order to obtain a~     better definition of the irradiated fields, we will co-register the SPECT/ Low dose CT with~     high-resolution CT provided from the Institute of Radiotherapy. In this procedure, the low~     dose chest CT is used as a bridge between high resolution CT and the functional imaging~     SPECT. Using the Q.Lung segmentation tool, individual whole lung function and lung subunits~     will be assessed, and will be correlated to irradiated fields. Calculated data for each study~     step will be compared in order to assess the extent of RT induced lung injury.~   "
33842|NCT03123666|"~     Informed consent obtained from the patient or the patient's legal surrogate. The window for~     randomization and initiation of study drug infusion is 2 days from day of Admission. All~     further time points are relative to the day of randomization. Patients will be randomized~     (1:1) to receive either recombinant human GM-CSF or placebo. Using randomized block design of~     10 each generated by computer and provided in sequential, sealed, opaque envelopes. Subjects~     will be stratified based on Child status. Patients who fulfil the inclusion criteria will~     receive either slow IV infusion of GM CSF (Sargamostatim-250mcg/M2) over 4 hour and~     inhalation of same dose by micronebulizer for 7 days OR Placebo(saline infusion and saline~     nebulization). Standard medical care will be given in both limbs.~   "
33843|NCT03123653|"~     -  Study population:Person with HBeAg negative CHB on TDF/ETV for more than 1 year~        -  Study design:Prospective,Interventional (single arm study)~        -  Study period: 2 year: January 2017 to December 2018~        -  Sample size: All the patients during the study period fulfilling the inclusion criteria~          will be included.~        -  Intervention: Peg IFN 2b 1.5mcg/kg once every week for 48 weeks~        -  Monitoring and assessment: LFT,HBV DNA and HbsAg at baseline,12 weeks,24 weeks,48 weeks~          ,72 weeks and 96 weeks, CBC every month and Thyroid function Test every 3rd month~        -  Adverse effects: The most frequently reported side effects of IFN-based therapy are~          flu-like symptoms, headache, fatigue, myalgia, alopecia, and local reaction at the~          injection site. Peg-IFN have myelosuppressive effects; however, neutropenia\1000/mm3 and~          thrombocytopenia \500,000/ mm3 are not common unless patients already have cirrhosis~   "
33844|NCT03123640|"~     Aim/Objective: Investigate the effect of implementing a working model for performing~     medication reconciliation (MR) and medication review (MRe) in the emergency department (ED),~     on readmissions, patient safety and efficiency of the stay in the ED and the hospital.~     Research design: randomized, controlled, non-blinded trial. Control group; standard care.~     Intervention group; MR and MRe performed at admission to the ED by a clinical pharmacist in~     the interdisciplinary team. The intervention is based on a working model for MR, developed in~     our initiation project, and it will be adapted to also include MRe. Key challenges in this~     research field: Currently no implemented systematic model ensuring that the patient`s correct~     medication list is obtained and assessed at the point of admission. There is lack of studies~     investigating the clinically outcome of performing MR and MRe in the ED. Lack of knowledge on~     the extent of drug related hospital admissions in Norway. These challenges are also~     recognized and prioritized by the Norwegian authorities. Impact and utility: The results from~     this study will give important answers to the challenges listed above. The results could~     imply a huge impact on how to organize ED in Norway regarding drug safety. If the hypothesis~     of this study is confirmed, implementing the intervention described will increase patient~     safety, both the hospital and society can reduce health care expenses from readmissions, and~     also the readmission-burden can be reduced for the patients.~   "
33845|NCT03123627|"~     Hypothesis: Valganciclovir prophylaxis can be discontinued before 3 months in~     CMV-seropositive renal transplant recipients receiving induction thymoglobulin when~     developing CMV-specific cellular immunity after transplantation.~      Objective Meet the efficacy and safety of valganciclovir prophylaxis suspend in~     CMV-seropositive kidney transplant recipients with CD8 + cellular immunity CMV-specific~     transplant, receiving Thymoglobulin induction and maintain cellular immunity-specific CD8 +~     CMV after transplantation.~      Design: noninferiority clinical trial (study A) in CMV-seropositive kidney transplant~     recipients with CMV-specific cellular immunity pretransplant (Quantiferon reactive CMV)~     received induction with thymoglobulin~      Patients meeting inclusion criteria will be randomized to:~        -  Control Arm: valganciclovir prophylaxis until day +90 as recommended by the~          International Consensus document of the TTS (Transplantation 2013:96:333-360).~        -  Experimental arm: prophylaxis with valganciclovir and determination of CMV-specific~          cellular immunity day +15, +30, +45 and +60. Prophylaxis was discontinued when the~          patient developed CMV-specific cellular immunity. Patients who did not develop CMV~          specific immunity continue prophylaxis until day +90.~      Analysis: The incidence of CMV disease according to the strategy used was calculated using~     Kaplan-Meier curves that were compared using the log-rank test.~   "
33846|NCT03123614|"~     Corneal haze, in which the cornea becomes cloudy, is a well-known and a potentially~     vision-threatening postoperative complication of PRK. Topical ophthalmic corticosteroids are~     routinely prescribed by most surgeons postoperatively to help prevent this complication.~      Goals of topical steroids use after PRK include effective modulation of the healing response~     to prevent corneal haze while at the same time minimizing side effects, such as intraocular~     pressure elevation or cataract formation. Loteprednol etabonate is a corticosteroid that~     exerts its therapeutic effects and is then quickly changed into inactive metabolites. This~     relatively fast metabolism of loteprednol gives it a lower side effect profile than other~     steroids, including a smaller effect on intraocular pressure. In the ophthalmic literature,~     there is currently no consensus on a standard regimen or which type of corticosteroid should~     be used after PRK.~      Investigators are conducting a prospective, randomized trial to compare the incidence of~     intraocular pressure rise and visually significant postoperative corneal haze after PRK with~     the use of loteprednol 0.5% gel compared to the use of earlier generation steroids,~     prednisolone acetate 1% suspension and fluorometholone 0.1% suspension.~   "
33847|NCT03123601|"~     BACKGROUND: Prior research has shown a relationship between dehydration, falls and pulmonary~     aspiration among older adults in nursing and health care facilities, which contributes to its~     loss of independence and quality-of-life. Is believed that improving communication among~     health professional decreases the number of adverse events in institutionalized patients.~     This study will evaluate the feasibility of a set of sign displays designed to communicate~     fall, dehydration and pulmonary aspiration risks and will reflect on tailored interventions~     to manage these events in nursing homes.~      METHODS AND ANALYSIS: This will be a national, single-center, feasibility study. All~     patients, with chronic neurologic diseases selected from a nursing home, will be invited to~     participate. At baseline patients will undertake a screening risk assessment and it will be~     attributed a correspondent risk display. Study duration will be a minimum of 3 months per~     participant, including daily record of events and monthly interview assessments. Events data~     will be compared with historical data extracted retrospectively from medical and nursing~     charts.~   "
33848|NCT03123588|"~     The purpose of this study is to evaluate the efficacy and safety of ruxolitinib versus~     anagrelide in subjects with essential thrombocythemia who are resistant to or intolerant of~     hydroxyurea.~   "
33849|NCT03123575|"~     This will be a cross-sectional population-based study carried out in the region of Madrid~     (6,468,322 inhabitants according to current census) to quantify the number of Co-meds in~     HIV-infected individuals on ART in the region of Madrid, categorized by age and gender, and~     to compare the number of Co-meds between the ART-treated population and HIV-uninfected~     population in the region of Madrid, categorized by age and gender.~   "
33850|NCT03123562|"~     The purpose of this study is to evaluate the safety and effectiveness of stem cells for~     cerebral palsy related to neonatal icterus~   "
33851|NCT03123549|"~     This study is intended to demonstrate that the Simplify® Cervical Artificial Disc (Simplify®~     Disc) is at least as safe and effective as conventional anterior cervical discectomy and~     fusion (ACDF) when used to treat two contiguous discs from C3 to C7 following discectomy at~     two contiguous levels for intractable radiculopathy (arm pain and/or a neurological deficit)~     with neck pain or myelopathy due to abnormalities localized to the levels of the two~     contiguous disc spaces in subjects who are unresponsive to conservative management.~   "
33852|NCT03123536|"~     There is currently a lack of evidence to support the use of perioperative point-of-care~     ultrasound to assess the outcomes in high risk surgical patients. Thus, the purposes of this~     study were to evaluate whether perioperative use of point-of-care ultrasound can reduce the~     worse postoperative outcomes in high surgical patients.~   "
33853|NCT03123523|"~     Anderson-Fabry disease is a genetic lysosomal storage disease, linked to chromosome X (gene~     GLA), responsible of enzyme synthesis deficit in α-galactosidase A with intracellular~     sphingolipids accumulation and multiorganic achievement.~      If renal complication is principally responsible of the pejorative evolution of the disease,~     it may also exist a cardiac achievement, symptomatic or not (heart failure symptoms including~     dyspnea, conduction abnormalities, supra-ventricular and ventricular arrhythmias), with or~     without left ventricular hypertrophy (LVH).~      Administration of agalsidase-α or ß, a genetic engineering synthetic equivalent of the~     deficient enzyme, should significantly slow disease evolution indeed reduce LVH.~      Some patients with Fabry disease without LVH should present, compared to healthy subjects,~     indirect early markers of intramyocyte lipid overload:~        -  in echocardiography, longitudinal myocardial deformation (strain) should be altered~          while ejection fraction is preserved, and~        -  in cardiac MRI, T1 mapping should be reduced1. This was also previously demonstrated in~          Fabry patients with LVH2. However, are these abnormalities of longitudinal deformation~          in echocardiography and of T1 mapping in MRI correlated to the presence of pejorative~          cardiac markers (such as clinical and functional tolerances, Brain Natriuretic Peptide~          (BNP) level and electrical complications)?~   "
33854|NCT03123510|"~     The objective of the trial is to study how a synbiotic treatment will affect weight loss and~     management in individuals enrolled in weight loss diet Profile®. The investigators propose to~     follow up 2 cohorts of Profile® subjects during 6 months. One group will receive a synbiotic~     treatment supplement (Bifidobacterium spp plus bimuno- galacto-oligosaccharides (B-GOS))~     while the other group will receive placebo capsules. Anthropomorphic and metabolic analysis~     will be performed by-monthly. Fecal samples will be obtained before and after the dietary~     intervention and samples will be sequenced trough next generation DNA sequencing to analyze~     the gut microbiota. Because dietary interventions with high protein and low glycemic index~     have been shown to be effective in reducing weight, but has also been linked to potential~     colon harm due to increased fermentation of undigested protein on the colon, the~     investigators expect supplementation of Profile® with a synbiotic product will lead to an~     increased overall wellbeing without compromising weight management.~   "
33855|NCT03123497|"~     Assessment of quality of life of patient with chronic idiopathic thrombocytopenic purpura~     according to the type of treatment~   "
33856|NCT03123484|"~     Epidermal Growth Factor Receptor tyrosine-kinase inhibitors （EGFR-TKIs）, including~     gefitinib，erlotinib and icotinib demonstrate excellent effect on the treatment of non small~     cell lung cancer (NSCLC) patients with EGFR mutations. However, patients who are initially~     sensitive to the drugs eventually become resistance. In this study, the investigators aim to~     explore the efficacy of beta-elemene, combining with EGFR-TKI in advanced non-small cell lung~     cancer with EGFR-TKI resistance.~   "
33857|NCT03123471|"~     This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the~     efficacy and safety of apremilast (CC-10004) in subjects with moderate to severe plaque~     psoriasis of the scalp.~      Approximately 300 subjects with moderate to severe plaque psoriasis of the scalp will be~     randomized 2:1 to receive either apremilast 30 mg twice daily (BID) or placebo for the first~     16 weeks.~   "
33858|NCT03123458|"~     The primary objectives are to evaluate the safety and efficacy of infusion of the third party~     fully-characterized clonally derived fetal MSCs (cfMSCs) for the control of severe symptoms~     associated with acute and chronic immune-related disorders and tissue damage.~   "
33859|NCT03123445|"~     Explore the efficacy and safety of the treatment of Endostar continuous intravenous injection~     pump combined GP（gemcitabine+cisplatin） scheme for first-line advanced non small cell lung~     cancer and maintenance treatment.~   "
33868|NCT03123302|"~     In this study we aim to investigate the relationship between our anesthesia practice and post~     procedure complications after MRI scanning with sedation. This is a prospective, single~     center observational study. All patients undergoing MRI scan during the study period will be~     included. The only exclusion criteria is the refusal of patients to participate to the study.~   "
33869|NCT03123289|"~     In the proposed study, our aim is to evaluate the uptake of 68Gallium-citrate in patients~     with failed joint prosthesis and compare it with that of conventional~     18fluorine-fluorodeoxyglucose (18F-FDG) positron emission tomography/computed tomography~     (PET/CT) scan. We will perform PET/CT scan with 68Gallium citrate and 18F-FDG in subjects~     with failed hip or knee prosthesis. Both 68Gallium-citrate and 18F-FDG scans, done within~     24-48 hours from each other, will be performed within 4 weeks before surgical~     evaluation/revision of the hardware.~   "
33870|NCT03123276|"~     Soft tissue sarcomas (STS) are a group of rare mesenchymal neoplasms affecting all ages. STS~     most commonly present as localised disease but despite surgery and adjuvant treatment more~     than half of patients will develop recurrent or metastatic disease. Leiomyosarcoma (LMS), a~     malignancy of smooth muscle, is one of the most common STS and undifferentiated pleomorphic~     sarcoma (UPS) is a common sarcoma sub-type with aggressive symptoms.~      Recent studies have demonstrated reasonable sensitivity of LMS to gemcitabine monotherapy~     with an objective response rate of 8-19%. However the overall survival is still only about 12~     months which illustrates the critical clinical need for improved therapies for advanced STS~     and sarcoma in general.~      In this study the investigators propose to combine the immune synapse checkpoint inhibitor~     with the cytotoxic and immune modulating agent, gemcitabine. It is hoped that this dual~     immunomodulatory approach will enhance the effect of pembrolizumab on PD-L1 expressing LMS~     and UPS, leading to a safe treatment with patient outcomes. This is a two part, phase I,~     single centre dose escalation and dose expansion study in the total of 24 patients with newly~     diagnosed metastatic or inoperable LMS and UPS. There will be approximately 12 patients in~     the dose escalation cohort (part A) and the starting dose will be a fixed dose rate (FDR)~     gemcitabine of 800 mg/m2 on day 1 and 8 of 21 days cycles in combination of 200 mg of~     pembrolizumab given as an infusion on day 1 every 3 weeks. The MTD cohort (part B) will then~     be expanded to a total of 12 patients in order to further evaluate the safety and~     tolerability of that dose as well as to preliminarily assess response to therapy.~      The study is sponsored by Royal Marsden NHS Foundation trust and the funding for the study is~     provided by Merck Sharp & Dohme Limited.~   "
33871|NCT03123263|"~     This study retrospectively looks at changes in Echocardiographic parameters while using~     transtuzumab~   "
33872|NCT03123250|"~     Single-arm, interventional pivotal clinical trial collecting patient data from use of the~     AQUABEAM System, a personalized image-guided waterjet resection system that utilizes a~     high-velocity saline stream to resect and remove prostate tissue in males suffering from~     Lower Urinary Tract Symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH).The primary~     endpoints for safety and effectiveness will be measured at 3 months post-treatment. All~     treated subjects will be followed out to 12 months to collect long-term clinical data.~   "
33873|NCT03123237|"~     the investigators explore the possible role of DMSA to detect renal affection in diabetic~     &/or hypertensive patients by detecting difference in counts using Tc 99m DMSA in control &~     diabetic &/or hypertensive patients.~   "
33874|NCT03123224|"~     This study evaluates the effect of a physical exercise + caregiver skills training on~     feelings of burden, mood, and biological markers of inflammation in persons who provide care~     for Veterans with a TBI or dementia. Half of the caregivers will participate in a balance and~     flexibility + caregiver skills training program, while the other half will participate in a~     moderate/high intensity aerobic and resistance + caregiver skills training program.~   "
33875|NCT03123211|"~     This is an expanded access program (EAP) for eligible participants. This program is designed~     to provide access to Veliparib prior to approval by the local regulatory agency. Availability~     will depend on territory eligibility. Participating sites will be added as they apply for and~     are approved for the EAP. A medical doctor must decide whether the potential benefit~     outweighs the risk of receiving an investigational therapy based on the individual patient's~     medical history and program eligibility criteria.~   "
33876|NCT03123198|"~     This protocol establishes a research oriented psychological treatment clinic within the~     Graduate School of Applied and Professional Psychology (GSAPP), called the Dialectical~     Behavior Therapy Rutgers University Research Program (DBT-RU). The overall aim of the~     proposed research is to find ways to improve therapist training in existing treatments for~     complex and difficult-to-treat problems (e.g., DBT, prolonged exposure), develop new and more~     effective treatments, and improve understanding of severe psychopathology. Consequently, this~     proposed research will have four branches: (1) training of research clinicians and evaluation~     of training methods; (2) training of clinical evaluators for the research studies and~     evaluation of assessment training methods; (3) assessment of treatment outcome, including~     assessment of mediators and moderators of change (both clinician and client data); (4)~     assessment and analyses of psychopathology of subject populations who participate in the~     DBT-RU.~   "
33877|NCT03123185|"~     Investigation of safety, tolerability, pharmacokinetics and pharmacodynamics of single rising~     doses of BI 705564 and of the food effect on BI 705564 in healthy male subjects~   "
33878|NCT03123172|"~     Study will be conducted on 20 patients ASA III-IV undergoing orthotopic liver~     transplantation. Blood samples will be obtained simultaneously from arterial line, pulmonary~     artery catheter and central venous catheter at 4 specific time points baseline, immediately~     after insertion of PAC; at the end of the dissection phase; 30 minutes after anhepatic phase;~     30 minutes after unclamping. Blood samples will be also obtained whenever PPV is more than~     15% and patient will need fluid therapy~   "
33879|NCT03123159|"~     The DxN Hepatitis B Virus (HBV) Assay is an in vitro diagnostic assay intended as an aid in~     the management of HBV-infected individuals undergoing antiviral therapy. The purpose of the~     study is to establish the clinical performance of the DxN HBV Assay for plasma samples in the~     intended use population.~   "
33903|NCT03122847|"~     Continuous use of systemic glucocorticoids decreases bone mineral density and increases~     fracture risk. Graves' orbitopathy is treated with weekly infusion of high-dose intravenous~     glucocorticoid. The investigators aim at investigating whether this treatment regimen also~     affects bone metabolism.~   "
33912|NCT03122730|"~     The purpose of the Phase 2a study is to: 1) demonstrate that the estimated VentaProst dose is~     safe and equivalent in effect to a dose administered via epoprostenol aerosolization by the~     current off-label-use practice; and 2) demonstrate that an optimum effect can be rapidly~     obtained with VentaProst titration.~   "
33880|NCT03123146|"~     Individuals with high functioning autism spectrum disorder (ASD) frequently experience~     obsessions and/or compulsions that are similar to those specified in Diagnostic and~     Statistical Manual of Mental Disorders (5th ed.; DSM-5) criteria for obsessive compulsive~     disorder (OCD). However, little research exists on effective interventions for OCD symptoms~     (referred to as OCBs) in ASD. In a randomized controlled trial, a manualized functional~     behavior-based cognitive-behavior therapy (Fb-CBT) consisting of traditional CBT components~     (psychoeducation and mapping, cognitive-behavioral skills training, exposure, and response~     prevention) as well as function-based behavioral assessment will be evaluated. Participants~     will be assigned randomly to Fb-CBT or treatment as usual (TAU). Primary and secondary~     outcome measures will be used to evaluate the efficacy of the treatment, and will be~     administered at pre and post-intervention as well as six month follow-up.~   "
33881|NCT03123133|"~     To verify and validate a biodosimetry test for determining absorbed ionizing radiation dose~     by analyzing gene expression signatures of blood samples collected from patients treated with~     Total Body Irradiation (TBI).~   "
33882|NCT03123120|"~     The objectives of this trial are safety and efficacy (proof-of-concept) of induction of~     mucosal healing by BI 655130 add-on therapy in patients with mild or moderate ulcerative~     colitis and persisting endoscopic activity despite pre-existing TNFi treatment.~      This trial will explore safety and efficacy of a dose of BI 655130 that was modelled to~     achieve the similar exposures as the highest exposures tested and found safe and tolerable in~     preceding single and multiple dose studies in healthy subjects, as add-on to pre-existing~     TNFi (Tumor necrosis factor inhibitor) treatment. Secondary and further objectives include~     assessment of the pharmacokinetic (PK) profile of BI 655130 and early exploration of specific~     biomarkers with potential usefulness to predict clinical efficacy or safety outcome or help~     understand BI 655130`s mode of action.~   "
33883|NCT03123107|"~     Postoperative atrial fibrillation (POAF) is a common complication following cardiac surgery~     that increases the incidence of stroke, kidney injury and death. Vitamin C has been shown to~     decrease the incidence of POAF follow cardiac surgery, but the optimal dose has not been~     identified. With this project, the investigators plan to gather pharmacokinetic and~     dose-response data for vitamin C in the cardiac surgery population. The investigators plan to~     conduct a small interventional pilot study investigating the pharmacokinetics and~     pharmacodynamics of Vitamin C in patients undergoing coronary artery bypass graft (CABG)~     surgery. Patients enrolled will receive an intravenous dose of Vitamin C the day before~     surgery and the day after. Patients will have blood samples obtained with each dose for~     analysis of vitamin C concentrations and several biomarkers of oxidative stress. Analysis of~     samples will be performed within the Department of Pharmaceutical Sciences at Wilkes~     University.~   "
33884|NCT03123094|"~     The primary objective of this trial is to investigate the safety and tolerability of BI~     655130 following administration of single rising intravenous doses and single subcutaneous~     dose in healthy Japanese male volunteers.~      Secondary objective is the exploration of the pharmacokinetics including dose proportionality~     of BI 655130 in healthy Japanese male volunteers.~   "
33885|NCT03123081|"~     The purpose of this study is to investigate the efficacy and safety of umbilical cord milking~     in depressed neonates at birth for prevention of hypoxic ischemic encephalopathy.~   "
33886|NCT03123068|"~     This double-blind, placebo-controlled proof-of-concept clinical trial is intended to~     demonstrate that preemptive oral administration of cocoa flavanol for five days before~     surgery will attenuate the surgery-evoked increase of HMGB1 in blood plasma and NFkB~     signaling in innate immune cells shortly after surgery. A secondary aim is to capture~     preliminary patient-centered outcomes data and relate these outcomes to the intake of oral~     cocoa flavanol and surgery-evoked activation of the HMGB1-NFkB signaling axis. Participants~     will be randomized to receive either an over the counter supplement containing cocoa~     flavanols, or placebo, for 5 days before surgery.~   "
33887|NCT03123055|"~     This is a Phase 1b/2 multi-center, open-label study to establish the initial safety and to~     determine a recommended Phase 2 dose of B-701 in combination with pembrolizumab, and to~     determine safety, tolerability and efficacy of B-701 plus pembrolizumab in the treatment of~     subjects with locally advanced or metastatic UCC, who have progressed following~     platinum-based chemotherapy and who have not received prior immune checkpoint inhibitor~     therapy.~   "
33888|NCT03123042|"~     Purpose: To prove the feasibility of sentinel node navigation surgery (SNNS) in early gastric~     cancer patients with the risk of lymph node metastasis after endoscopic resection and~     preparation of multicenter phase 3 trial of stomach preserving surgery in these patients.~      Contents: The number of enrollment is 247 patients. The patients underwent endoscopic~     resection for early gastric cancer, and the tumor was defined to be out of indication for~     endoscopic resection pathologically. So, additional gastrectomy is recommended for them.~      The investigators will enroll patients who agree this study. After general anesthesia,~     Tc99m-Phytate with indocyanine green will be injected with endoscopy. Then sentinel basin~     will be detected using gamma probe and laparoscopic basin dissection will be done. Sentinel~     lymph node will be identify in back table dissection, and patients will undergo conventional~     gastrectomy. Detection rate and false negative rate will be evaluated by pathological review.~   "
33889|NCT03123029|"~     This is an expanded access program (EAP) for eligible participants. This program is designed~     to provide access to Venetoclax prior to approval by the local regulatory agency.~     Availability will depend on territory eligibility. Participating sites will be added as they~     apply for and are approved for the EAP. A medical doctor must decide whether the potential~     benefit outweighs the risk of receiving an investigational therapy based on the individual~     patient's medical history and program eligibility criteria.~   "
33910|NCT03122756|"~     *Aim of the Work This study aims to assess the efficacy of intravenous injection of~     dexamethasone prior to spinal anesthesia in reducing post-cesarean section pain in women~     undergoing cesarean section.~   "
33911|NCT03122743|"~     This pilot research trial studies the collection of serum samples in studying emotional~     stress in patients with prostate cancer. Studying serum samples from patients with prostate~     cancer in the laboratory may help doctors determine if levels of epinephrine and cortisol,~     substances the body makes when stressed, rise or fall with how patients are feeling and/or if~     those levels are related to clinical information related to prostate cancer.~   "
33890|NCT03123016|"~     Vitiligo is a common acquired disorder of pigmentation affecting 0.5% to 1% of the world~     population. Sharply demarcated patches of depigmentation, which can affect all ethnicities,~     and can lead to cosmetic disfiguration and psychosocial distress, characterize the disease.~     The etiology of vitiligo remains unknown. Various mechanisms have been proposed, such as~     autoimmunity, self-destruction, biochemical, genetic, neural, oxidative stress, and an~     imbalance of epidermal cytokines leading to inflammation and selective loss of epidermal~     melanocytes. Currently, the most popular theory is autoimmunity. Previous studies noted that~     around 25-30% of patients have at least one other autoimmune disease, such as autoimmune~     thyroid disease, Addison's disease, pernicious anemia, and alopecia areata. Currently, NB-UVB~     phototherapy is the most widely used therapeutic option for vitiligo affecting more than~     10-20% of the skin surface, as it is generally considered to be a safe initial treatment.~     Potential side effects include phototoxic reaction, thickening of the skin and~     koebnerization. NB-UVB is a band of UV radiation with a wavelength of 311-313 nm. UVB induces~     mitogenesis and migration in melanocytes mediated by several factors such as IL-1, TNF alpha,~     and leukotriene C4. UV radiation produces increased number and activity of melanocytes,~     increased melanin density, elongation and branching of dendrites, with increased transfer of~     more heavily melanized melanosomes to keratinocytes, seen clinically as increased~     pigmentation. Apremilast is an oral small molecule phosphodiesterase-4 (PDE4) inhibitor that~     has been shown to regulate inflammatory mediators. Apremilast enters cells by passive~     diffusion and, once intracellular, binds PDE4. PDE-4, the dominant phosphodiesterase~     expressed in immune cells, degrades cyclic AMP (cAMP) into AMP. PDE4 inhibition thereby~     elevates intracellular cAMP, which can down-regulate the inflammatory responses such as~     TNF-α, IFN-γ, interleukins (IL) 2, 12 and 23 through mechanisms such as partially inhibiting~     expression of inflammatory cytokines and increasing expression of anti-inflammatory mediators~     such as IL2 and IL10. The hypothesis is that apremilast will shut down the inflammatory~     insult in vitiligo and NB-UVB phototherapy will then be able to regenerate melanocytes and~     their activity. By examination of skin biopsies taken pre- and post-therapy, the study team~     aims to assess changes in immune and cellular markers in affected skin.~   "
33891|NCT03123003|"~     Bone age assessment in children is based on the interpretation of hand x-ray scans according~     to Greulich and Pyle (GP) standard atlas and frequently used for evaluating growth and~     puberty in children and adolescents.~      To address the disadvantage of repeated irradiation, the need for specialized radiation~     centers, heavy equipment and subjective reading a new device, SonicBone was developed.~     SonicBone utilizes a quantitative ultrasonographic technology of ultrasonic (US) waves,~     propagating along a measured bone distance. The aim of the study is to evaluate an ultrasound~     based device, SonicBone, compared to the current method in children. The investigators will~     be compared the US assessment to available bone age X-ray that exists in the medical files of~     the patients. The investigators will not do bone age X-ray scans especially for the current~     study.~   "
33892|NCT03122990|"~     The aim of this study is to compare quadrant scaling and root planing (Q-SRP) versus~     full-mouth treatment (FM-SRP) in terms of acute-phase responses following non surgical~     periodontal treatment in patients affected by periodontitis and high blood pressure.~   "
33893|NCT03122977|"~     The aim of this study is to compare quadrant scaling and root planing (Q-SRP) versus~     full-mouth treatment (FM-SRP) in terms of acute-phase responses following no surgical~     periodontal treatment in obese patients affected by periodontitis.~   "
33894|NCT03122964|"~     The primary objective of this study is to evaluate the performance of the methylation marker~     panel for the detection of bladder cancer in patients with gross or microscopic hematuria.~   "
33895|NCT03122951|"~     The Clearblue® Advanced Ovulation Test is designed for home use by women who are either~     planning or trying for a pregnancy.~      The purpose of this protocol is to demonstrate that lay-users representative of the target~     user population are able to use the product in the intended user environment.~   "
33896|NCT03122938|"~     To assess the effects of a lactoferrin supplemented formula on fetal development , iron~     metabolism and immunity in healthy pregnant women. One hundred and twenty healthy pregnant~     women (24<gestational weeks<26) are enrolled and randomly assigned to~     lactoferrin-supplemented formula group (active group) or normal formula group (control group,~     without lactoferrin supplementation). Subjects allocated in active group consume lactoferrin~     supplemented formula (85mg lactoferrin per 100g) 3 times a day (81g totally), while those in~     control group consume formula without lactoferrin supplementation (<6mg lactoferrin per 100g~     formula) according to the same schedule. Routine blood test including hemoglobin and serum~     ferritin, and food frequency questionnaire-based review and 24h*3 dietary record are~     performed every 4 weeks during intervention until delivery. Body weight of newborns are~     recorded after delivery. The differences in iron deficiency anemia morbility of pregnant~     women and anthropometric measurements of newborns between groups would be analyzed after~     completion of this study.~   "
33897|NCT03122925|"~     OBJECTIVE: To measure the tricarboxylic acid (TCA) cycle rate in the dentate nucleus in a~     group of control subjects and subjects with Friedreich's Ataxia (FRDA).~      HYPOTHESIS: The TCA cycle rate will be lower in FRDA subjects than in controls APPROACH: The~     investigators will infuse carbon-13 (13C) labeled glucose and measure the rate of 13C label~     incorporation from glucose to glutamate in the brain using in vivo magnetic resonance~     spectroscopy.~   "
33898|NCT03122912|"~     The purpose of this study is to explore the potential differences in the skin of people who~     take fish oil versus soybean oil pills.~   "
33899|NCT03122899|"~     SALLY studies sacroiliac joint fusion with the iFuse-3D implant.~   "
33900|NCT03122886|"~     This randomized pilot trial studies how well fat emulsion works in preventing~     hypersensitivity reactions in patients with cancer receiving carboplatin or oxaliplatin.~     Giving lipids before chemotherapy may prevent some drug reactions from carboplatin or~     oxaliplatin.~   "
33901|NCT03122873|"~     The study is designed to quantitate McArdle's sign, an increase in measurable weakness with~     neck flexion described in patients with multiple sclerosis, and to determine whether it is or~     is not specific for multiple sclerosis.~   "
33902|NCT03122860|"~     This phase 2 study is a placebo-controlled, double-blind, parallel group study of four~     concentrations of SM04690 (0.03, 0.07, 0.15, and 0.23 mg per 2 mL injection) injected~     intraarticularly (IA) into the target knee joint of subjects with moderately to severely~     symptomatic osteoarthritis (OA). Based on previous studies of SM04690, key phenotypes of~     laterality (unilateral vs bilateral) as well as chronic pain (as measured by the Widespread~     Pain Index) were identified as confounding variables impacting the overall assessment of both~     radiologic and clinical efficacy outcomes. The design of SM04690-OA-04 is based upon previous~     study designs while assessing strategies to combat the confounding impact of laterality and~     chronic pain. To evaluate the effect of IA vehicle injection on patient-reported outcomes~     (PRO) such as pain, stiffness, and function in OA, this study will also include two placebo~     cohorts-one cohort that receives a 2 mL IA injection of vehicle, and one cohort that receives~     a sham injection (i.e., a needle stick with 0 mL vehicle injected).~   "
33904|NCT03122834|"~     Heart failure (HF) is one the most common cause of hospitalization and represents the end~     stage of a variety of heart conditions; it is associated with significant morbidity and~     mortality.The pathophysiology of HF is centered on increased activity in the adrenergic and~     renin-angiotensin-aldosterone systems (RAAS), which leads to vasoconstriction and fluid~     restriction with further deleterious effect on cardiac function. Β-blockers, angiotensin~     converting enzyme inhibitors (ACEIs)/angiotensin II receptor blockers (ARBs) and aldosterone~     antagonists reduce activity in these pathways and have shown prognostic benefit, thus are the~     foundation of HF therapy.There is a growing body of evidence that variation in proteins~     within the sympathetic axis and RAAS influence drug response thus increasingly~     pharmacogenetics of HF research is being sought as a way to optimize HF treatment and advance~     new drug development in this area.~   "
33905|NCT03122821|"~     Noninvasive brain stimulation (NIBS) refers to a group of modalities that are used to induce~     electric currents to and within the brain for diagnostic or therapeutic purposes. Two major~     types of NIBS techniques are currently in use on humans for clinical and research~     applications: Transcranial Magnetic Stimulation (TMS) and Transcranial Current Stimulation~     (tCS). Moreover, the studies evaluating the clinical benefit of mental practice in stroke so~     far are mostly small feasibility studies, while the few randomized controlled trials reported~     had relatively small sample sizes. As such, the evidence for mental practice in the treatment~     of movement disorders following stroke, and other neurological conditions, remains somewhat~     anecdotal. Purpose of our research is to show the effect of combining brain stimulation and~     mental imagery on functional recovery of upper limb in stroke.~   "
33906|NCT03122808|"~     Excessive uterine activity may be one of several aetiological factors that contribute to~     depressed neurological function in the newborn. During labour, uterine contractions can~     compress the fetal cranium at pressures high enough to impair cerebral perfusion. Contraction~     rates greater than 7 in 15 minutes are associated with an increased risk of neonatal~     encephalopathy.~      The American Congress of Obstetricians and Gynecologists defines uterine tachysystole as more~     than 5 contractions in 10 minutes, averaged over a 30-minute window. By this definition,~     excessive uterine activity is common and, at best, a non-specific predictor of depressed~     neurological function in the newborn. There is a need for predictors of neonatal~     encephalopathy that are more specific and clinically applicable.~      Contraction and relaxation duration are two measures that closely reflect the proposed role~     of excessive uterine activity in the pathogenesis of neonatal encephalopathy. Prolonged~     contractions with short relaxation periods result in progressive reductions in fetal cerebral~     oxygenation. Shorter uterine contraction periods are associated with an increased risk of low~     umbilical cord potential of hydrogen (pH) values.~      Our primary aim is to measure parameters of uterine activity, for example relaxation and~     contraction duration, and determine their relationship with the risk of neonatal~     encephalopathy. We will also investigate how measures of uterine activity interact with other~     measures of labour and fetal well-being, including cervical dilation rates and fetal heart~     rate patterns. In babies with neonatal encephalopathy, we will investigate the relationship~     of uterine activity with electrophysiological, radiological and developmental outcomes.~      We will perform a retrospective case-control study of babies born in the Rotunda hospital~     from 2005 until the present. The assessor of the Cardiotocograph (CTG) recordings will be~     blind to the disease status of the infants. For each recording, every uterine contraction and~     rest interval will be measured. Summary variables created from these measures will be used to~     compare the case and control groups. The primary variable will be mean rest interval~     duration.~   "
33907|NCT03122795|"~     Chronic rhinosinusitis (CRS) is a disease associated with impaired quality of life and~     substantial societal costs. Though sometimes co-appearing with other conditions, such as~     asthma, allergy, and nasal polyps, many cases present without co-morbidities.~     Micro-biological diagnostic procedures are frequently undertaken, but the results are often~     inconclusive. Nevertheless, antibiotics are usually prescribed, but invariably with limited~     and temporary success. Accordingly, there is a need for new treatments for CRS.~      Recent studies indicate that the sinuses are colonized by a commensal microbiome of bacteria~     and that damage to this natural microbiome, by pathogens or antibiotics, may cause an~     imbalance that may promote CRS. Therefore, treatments that restore the commensal microbiome~     may offer an alternative to current protocols. Arguably, as suggested by studies on patients~     with intestinal infections (next paragraph), one such possibility may be to transfer a~     normal microbiome to patients with CRS.~      A disrupted microbiome is linked to intestinal clostridium difficile infections. Probiotic~     restitution therapy may be effective even in cases recalcitrant to antibiotic treatment.~     However, a key to effective probiotic restitution is selecting the bacteria that facilitate~     regrowth of normal microbiome. As an answer to this, researchers have chosen to simply~     transplant the entire microbiome from a healthy donor. In the case of clostridium difficile~     infection in the form of faecal transplants.~      In this study, we will examine the possibility to treat patients with chronic rhinosinusitis~     without polyps (CRSsNP) with complete sinonasal microbiomes obtained from healthy donors. Our~     analysis will focus on symptoms and signs of disease as well as on nasal inflammatory and~     microbiological indices.~   "
33908|NCT03122782|"~     Study Design:~      Randomized Controlled Clinical Trial.~      Study Population:~      The study population will be a consecutive series of participants attending the Early Cancer~     Detection Unit (ECDU) at Ain Shams University Maternity Hospital.~      80 women who are scheduled to undergo a hysteroscopic myomectomy will be included and will be~     randomized into two groups:~      Group A: women will undergo a hysteroscopic myomectomy with the use of (TXA) Kapron in the~     distention medium~      Group B: women will undergo hysteroscopic myomectomy with the use of placebo(normal saline in~     the distention medium).~      Randomization will be performed using a Computer-generated randomization system.~      The allocated groups will be concealed in serially-numbered sealed opaque envelopes that will~     only be opened after recruitment.~      Patient allocation will be performed prior to the induction of anesthesia by an independent~     person, who will not otherwise be involved in this study.~      The trial will be appropriately blinded; the participants, outcome assessors and the surgeon~     performing the procedure will be blinded to the medication type, which will be used inside~     the distention medium.~      Therefore, this study will be a randomized double blind prospective clinical~      Methodology:~        1. Informed written consent obtained from the participant.~        2. History~             1. Personal history~             2. Menstrual history~             3. Detailed obstetric history~             4. Surgical intervention especially uterine surgeries and any post-operative~               complication~             5. History of drug intake, especially hormonal treatment or anticoagulant therapy.~        3. Routine preoperative investigations in addition to a serum pregnancy test if pregnancy~          is suspected.~        4. Physical examination including general, abdominal and pelvic examination.~        5. Hysteroscopy will be performed in the early proliferative phase using normal saline as a~          distention medium.~        6. Only in intervention group (TXA group) KAPRON (Tranexamic acid) will be added to the~          injected media.~             -  In intervention group 500 mg of Kapron for every 500 ml of distending media will be~               added.~             -  In the control group, placebo .i.e. ,normal saline in the same form will be~               injected inside every 500 ml of the distention medium.~        7. The trial will be appropriately blinded; the participants, outcome assessors and the~          surgeon performing the procedure will be blinded to the medication type, which will be~          used inside the distention medium. Therefore, our study will be a randomized double~          blind prospective clinical trial.~        8. Intraoperative bleeding and quality of view will be observed.~        9. A blood sample will be taken from each participant in both groups after 24 hours from~          the end of the operation for both hemoglobin and hematocrit levels.~      Types of outcome measures:~      Primary outcome measures:~      Estimated Blood loss defined as comparing the hematocrit and hemoglobin at base line~     (preoperative ) and 24 hours after surgery with the Tranexamic acid compared to the control~     group.~      Secondary outcome measures:~      The quality of view, duration of surgery, the volume of injected media, intraoperative~     complications and the success of the completion of the operation will be secondary outcomes.~   "
33909|NCT03122769|"~     The purpose of the study is to evaluate if metformin is taken up into the failing myocardium.~     Recent experimental and epidemiological studies have shown beneficial effects of metformin on~     heart failure. It is unknown whether this effect is direct or indirect.~      The aim of the study is to investigate if metformin is taken up in heart failure using a~     novel 11C-metformin tracer and positron emission tomography (PET).~   "
33913|NCT03122717|"~     This research study is studying a combination of two drugs as a possible treatment for~     Non-Small Cell Lung Cancer (NSCLC) with an EGFR mutation.~      The interventions involved in this study are:~        -  Osimertinib (Tagrisso)~        -  Gefitinib (Iressa)~   "
33914|NCT03122704|"~     This is a cross - sectional study to determine the prevalence of GBS infection and associated~     factors in preterm labor women conceived through ART.~      221 subjects will be involved.~   "
33915|NCT03122691|"~     This research is being done to measure the effects of both oral and vaporized cannabis~     (marijuana), at different doses, on the ability to perform certain tasks such as balancing,~     eye tracking, and computerized measures of memory and attention. The investigators will~     collect biological fluids (urine, blood, saliva/spit) after cannabis is eaten or vaporized to~     see if there are markers in those fluids that can predict performance on the tasks. The~     results of this study will help us better understand the effects of using cannabis, and to~     help identify behaviors and/or substances in the body that relate to cannabis impairment.~   "
33916|NCT03122678|"~     To determine if intravenous thiamine would decrease the time to reversal of shock in patients~     with septic shock.~   "
33917|NCT03122665|"~     Nefopam may help blunt thermoregulatory defenses, thus facilitating induction of therapeutic~     hypothermia~   "
33918|NCT03122652|"~     Multiple sclerosis (MS) is a common cause of severe neurological disability in young adults,~     resulting from an autoimmune interruption of both myelin and axons within the central nervous~     system (CNS). The diagnosis is made by fulfilling both spatial criteria, by meeting the~     requisite number of lesions within the brain or spinal cord, along with criteria for time, by~     demonstrating a history of at least a second clinical attack or the development of a new MS~     lesion on MRI after the seminal neurological event. In the case of MS, healthy individuals~     who do not exhibit signs of neurological dysfunction commonly have brain MRI studies~     performed for a reason other than an evaluation for MS that reveal unexpected anomalies~     highly suggestive of demyelinating plaques given their size, location, and morphology. These~     healthy subjects lack symptomatology suggestive of MS and fulfill formal criteria for~     radiologically isolated syndrome (RIS), a recently described MS subtype that expands upon the~     phenotype of at-risk individuals for future demyelinating events. The discovery of such~     anomalies creates intersecting neuro-ethical, legal, social, and practical medical management~     quandaries and is, therefore, of both immediate and long-term clinical significance. Despite~     advancements in the characterization of RIS subjects, and in our understanding of risk~     factors for initial symptom development, the effect of treatment on such cases remain~     unclear.~      The purpose of this investigation is to systematically study the efficacy of Teriflunomide in~     those individuals who possess incidental white matter anomalies within the brain and~     following a MRI study that is performed for a reason other than for the evaluation of MS.~      RIS subjects are frequently exposed to disease modifying therapies despite the lack of~     scientific literature supporting the use of such treatments. Earlier treatment intervention~     may extend the time to the first acute or progressive clinical event resulting from CNS~     demyelination and reduce radiological progression. In addition, early treatment may result in~     more profound effects on reducing disability progression long-term.~      The primary outcome measure for this trial is the time to the first acute or progressive~     neurological event resulting from CNS demyelination.~      This study will include RIS subjects from the Europe who fulfill 2009 RIS Criteria.~   "
33919|NCT03122639|"~     Obstructive sleep apnea (OSA), a condition that affects a quarter of the Western adults,~     triples the risk for cardiovascular diseases and increases all-cause mortality. Intermittent~     hypoxia (IH) during transient cessation of breathing in OSA leads to endothelial~     inflammation, a key step in the initiation and progression of cardiovascular disease.~     However, the mechanisms that mediate IH-induced endothelial inflammation remain unclear and,~     consequently, no targeted therapy is available for vascular manifestations of OSA. Using~     endothelial cells (ECs) freshly harvested from OSA patients, they study team has identified~     impaired complement inhibition as an initial stimulus for endothelial inflammation in IH,~     thereby linking for the first time complement activation to vascular risk in OSA. The~     investigators found that a major complement inhibitor cluster of differentiation (CD59), a~     plasma membrane protein that inhibits the formation of the terminal complement membrane~     attack complex (MAC) and protects host cells from complement injury, is internalized from the~     EC surface in OSA patients. Consequent MAC deposition initiates endothelial inflammation in~     IH. Importantly, the investigators showed that IH does not significantly affect inflammation~     in ECs in the absence of complement, suggesting that complement activation has an essential~     role in endothelial inflammation in OSA. Interestingly, internalization of CD59 in IH appears~     to be cholesterol-dependent and statins prevent MAC deposition on ECs in IH in a~     CD59-dependent manner, suggesting a novel therapeutic strategy to reduce vascular risk in~     OSA. This led the study team to hypothesize that IH-induced cellular cholesterol accumulation~     reduces complement inhibition via increased internalization of CD59 from the EC surface~     leading to increased MAC deposition, and that treatment of OSA with continuous positive~     airway pressure (CPAP) and/or statins reverses endothelial dysfunction by restoring~     complement inhibition.~   "
33920|NCT03122626|"~     After a stroke, people find it difficult to perform everyday activities independently, like~     getting dressed, preparing meals, and shopping, limiting their independence and requiring the~     assistance of a family member, friend or a home care worker. Losing one's independence can~     decrease quality of life. Functional exercise classes run by physical therapists where people~     with stroke practice getting in and out of a chair, stepping, and walking, can improve the~     ability to balance, walk, and do everyday activities. These classes are not commonly~     available in community centres, mainly because fitness instructors do not receive training in~     how to run exercise classes for people with stroke. Therefore there is a need to make these~     functional exercise programs available in local community centres.~      The objective of this project is to test procedures for running a large study to see whether~     people with stroke improve their ability to do everyday activities after participating in~     functional group exercise classes for 12 weeks in local community centres. If ability to do~     everyday activities improves, the investigators wish to see if the improvement is still~     present 3, 6 and 9 months later. Physical therapists at a nearby hospital will teach fitness~     instructors how to run the exercise class, help out during the classes, and answer questions~     by email or phone. Before conducting the larger Canada-wide study, it is important to~     determine the interest in such a program, the acceptability of the evaluations and the costs~     associated with the program, the degree of improvements resulting from the program, and if~     fitness instructors are able to run the program as planned.~      In Toronto, London and Pembroke, Canada, managers at a hospital and a nearby recreation~     centre have agreed to help run the exercise program. A recruiter will ask people with stroke~     who can walk and are being discharged home from the hospital whether they can be called about~     the study. People with stroke and a caregiver who agree to participate in the study will~     complete four evaluations when they enter the study, and 3, 6, and 12 months later. At each~     evaluation, people with stroke will perform tests of balance and walking, and complete~     questionnaires about their mood, participation in valued activities, and quality of life.~     After the first evaluation, the investigators will use a process like flipping a coin, to see~     if the person with stroke will begin the exercise program immediately or 12 months later. The~     investigators will call people each month to ask if a fall occurred. The investigators will~     interview exercise participants, family members and hospital/recreation staff at the end of~     the study to ask about the experiences.~      This project is unique because the program combines the expert knowledge and skills of~     physical therapists and fitness instructors. The exercise program involves practicing~     everyday movements, making the exercises easy for fitness instructors and people with stroke~     to learn. Each exercise has multiple levels of difficulty so the instructor can adapt~     exercises to how the person is feeling. The exercise program does not require expensive~     equipment (e.g. chairs, stepping stools) and therefore can be offered in most community~     centres. Finally, an extensive network of hospitals providing stroke care and community~     centres run by recreation organizations exists in Canada. Thus, if this program is~     beneficial, it could easily be made widely available.~      With the number of Canadians living with the consequences of stroke increasing every year,~     access to a functional exercise programs in local community centres will improve their~     ability to function and live independently in the community and reduce the burden on family~     or caregivers and on the healthcare system.~   "
33921|NCT03122613|"~     UC is a chronic inflammatory bowel disorder with relapsing and remitting course. The efficacy~     of mesalazine in preventing relapse in patients with UC is well-known and supported by~     randomized studies. However, mesalazine can be associated with side-effects. In addition,~     drug compliance is suboptimal, especially when disease is not active. Curcumin is a natural~     phytochemical derived from the Indian spice turmeric. It is widely used, has potent~     anti-inflammatory, anti-oxidant and anti-tumour properties.~      The aims of this double-blind, placebo-controlled randomized trial is to assess the efficacy~     of curcumin in the prevention of relapse in patients with ulcerative colitis (UC).~   "
33922|NCT03122600|"~     the applicability of ankle brachial index (ABI) and B-type natriuretic peptide (BNP)~     measurement as cardiovascular risk prediction models during hospital stay in elderly patients~     undergoing vascular surgery.~   "
33923|NCT03122587|"~     The will investigate the feasibility and effectiveness of non-invasive transcranial~     alternating current stimulation (tACS) among treatment seeking substance users.~   "
33924|NCT03122574|"~     The purpose of this research was to estimate feasibility of an aromatherapy pain management~     intervention to reduce pain and distress caused by venipunctures in a pediatric population.~     The feasibility of the use of aromatherapy essential oil lavandula angustifolia for pain~     management intervention (Treatment Group) was compared to placebo aromatherapy with jojoba~     oil (Placebo Control Group) and to the current standard of care, which is no oil during a~     venipuncture (Standard of Care Control Group). Primary measured outcomes were assessed using~     a double-blind randomized design. The physiological measure of heart rate was taken over the~     course of four minutes at three different intervals to note the pattern of change that occurs~     during anticipatory anxiety resulting from the impending procedure, the procedural pain~     experienced during the venipuncture, and the residual fear common after completion of the~     venipuncture procedure. The Visual Analogue Scale (VAS) for pain and the Hospital Fears~     Rating Scale (HFRS) were administered to measure subjective pain and anxiety. Participants~     (N=21) were recruited from the Laboratory Medicine Unit of Children's National Health System.~     Feasibility was estimated based on the ability to inhale the full dose of oil without adverse~     effects and and ability to inhale the full dose within the ten-minute time frame. This study~     analyzed the effect of the aromatherapy pain management intervention, lavandula angustifolia~     aromatherapy, on the stress response of a pediatric population through observation of~     physiological and psychological indicators of pain and distress, in order to learn more about~     the pain and anxiety experienced during venipuncture and the use of aromatherapy to decrease~     pain and anxiety during venipuncture.~   "
33925|NCT03122561|"~     Paracetamol is an antipyretic drug that is taken orally at different times of the day in same~     dose. It is excreted mainly through renal route which may show diurnal variation. In this~     study, urinary excretion of paracetamol of 41 healthy men of same age group will be measured~     by HPLC after oral administration of 500 mg paracetamol tablet at morning, midday and night.~     The measured values will be compared in order to adjust doses of oral paracetamol at~     different times of the day.~   "
33926|NCT03122548|"~     The purpose of this study is to determine whether CRS-207 in combination with pembrolizumab~     is safe and effective in adults with recurrent or metastatic gastric, gastroesophageal~     junction, or esophageal cancer who have received one or two prior systemic chemotherapy~     treatment regimens for advanced disease.~   "
33927|NCT03122535|"~     The purpose of this study is to compare 70 and 110 degree side-cut angles on the same patient~     undergoing Femtosecond Laser-assisted in Situ Keratomileusis (FS-LASIK).~   "
33928|NCT03122522|"~     This study will help determine whether 2 doses of the combination (ipilimumab + nivolumab) is~     sufficient for patients with early benefit compared to the usual way of trying to give 4~     doses. If patients do not show early benefit after 2 doses, patients will be able to continue~     with additional ipilimumab + nivolumab, even beyond the standard 4 doses if felt in the best~     interest of the patient.~   "
33929|NCT03122509|"~     The purpose of this study is to test the safety and effectiveness of two investigational~     drugs (drugs that are not currently approved by the FDA) given in combination with radiation~     therapy or ablation.~   "
33930|NCT03122496|"~     The purpose of this study is to test the safety of durvalumab (MEDI4736) and tremelimumab in~     combination with radiation therapy and find out what effects, if any, this combination has on~     people, and whether it improves overall survival.~   "
33931|NCT03122483|"~     This multicenter prospective trial will evaluate the association between obstructive sleep~     apnea (OSA) and blood biomarkers in a representative population of consecutively enrolled~     symptomatic patients with a clinical suspicion of OSA.~   "
33932|NCT03122470|"~     MRI is being increasingly relied upon for detection, staging and management of prostate~     cancer. In this study patients with risk of prostate cancer will be recommended to have a~     pelvic MRI prior to the standard biopsy of the prostate and standard treatment of any~     detected prostate cancer. The results of the MRI will be compared to standard diagnosis~     techniques to see if cancer can be more accurately detected.~   "
33933|NCT03122457|"~     The study team plans to enroll a total of 40 subjects with self-reported perimenstrual acne.~     Eligible women will be over the age of 18 and not on any current therapy. The patients will~     first arrive for a screening visit, where they will be given questionnaires on acne quality~     of life (acne QOL) and subjective assessments as well as flare ups (as used in the study by~     Geller et al). The patients' skin will be assessed for inflammatory and non-inflammatory acne~     vulgaris. The baseline visit (day 1) will be scheduled for one week prior to the first day of~     menses (as studies indicate that most women have their acne flare during this time). The~     study team will perform a zit count (counting papules, pustules, and comedones) and global~     assessment, and the patient will be instructed to record their menses (which they will do for~     the duration of the study). The patients will then return in 2 weeks, at day 15, and they~     will be re-assessed. The patients will be dispensed the investigational product and~     instructed on its daily use. The patients will continue to return every 14 days to have their~     skin assessed until their final visit on day 99, one week after their 3rd menses on treatment~     (4th menses on study). The duration of the study per patient is approximately 4 months, and~     the study team anticipates an enrollment period of 12 months.~   "
33934|NCT03122444|"~     Comparing changes in biomarkers from a diagnostic core needle biopsy to surgical pathology~     specimen or repeat core needle biopsy.~   "
33935|NCT03122431|"~     No drug treatment is completely free of risk and lack of response, adverse events and poor~     adherence may affect its effectiveness. Within this context, this project aims to evaluate~     the importance of monitoring blood levels and salivary drug used in rheumatic autoimmune~     diseases in the monitoring of adherence to therapy. In addition, this project intends to use~     the monitoring of drug levels, based on pharmacokinetic studies and~     pharmacokinetics/pharmacodynamics modeling, to broaden the understanding of the possible~     cellular, tissue and immunological mechanisms involved in efficacy and adverse effects of~     these drugs with the prospect of reducing the damage and maintain therapeutic efficacy. The~     high-performance liquid chromatography (HPLC) coupled to mass spectrometry, which will be~     used to evaluate hydroxychloroquine, thalidomide, glucocorticoids, is considered the gold~     standard technology to qualitative and quantitative analysis of drugs in blood and its~     comparison with the dosage in the saliva is an improvement in simplification of the process.~     For biological agents the focus will be on the understanding the loss of efficacy and the~     possible role of anti-TNF antibodies using ELISA capture methodology.This project will be~     divided into four sections with their respective sub-projects according to the medications~     that will be studied: hydroxychloroquine, thalidomide, biologic agents and glucocorticoids.~   "
33936|NCT03122418|"~     Approximately half of the variation in the presentation and disease status of patients with~     Cystic Fibrosis (CF) is secondary to non-genetic variables.[1] These include household~     income, compliance with therapy, second hand smoke exposure and possibly exercise (although~     exercise has less evidence to support its influence on disease status). Recently increased~     attention has been focused on the role of exercise and quality of life for patients with CF.~     This study will evaluate the role of exercise in relation to the patient's perception of~     their quality of life. The primary outcome will be the overall change in the patient's Cystic~     Fibrosis Questionnaire - Revised (CFQ-R) over a one year period during which the participants~     are encouraged to exercise and use a personal fitness device to track their exercise. This is~     a prospective single group non-blinded study. Participants will be asked to wear a personal~     fitness device for 11-13 months. The change in CFQ-R score is the primary outcome and other~     secondary outcomes will include; (1) exacerbations of cystic fibrosis (through use of~     antibiotics), (2) change in subject's FEV1, (3) inpatient admission rates, (4) change in BMI~     and (5) change in 6 minute walk test. The study will take place at the Adult CF Clinic on the~     University of Oklahoma Health Sciences Center campus.~   "
33937|NCT03122392|"~     he idea of the experiment is to calculate the volume of fluid that is required to raise cuff~     pressure from 20 cmH2O to 120 cmH2O in the American Medical System's AMS 800 Artificial~     Urinary Sphincter (AUS).~   "
33938|NCT03122366|"~     Toll-like receptors (TLRs) play a key role in the innate immune system. Toll-like receptor-4~     (TLR4) in particular, appears to play a role in susceptibility to cancer. Of 44 identified~     SNPs (small nucleotide polymorphisms) in TLR4, the most common is an A-G substitution at~     nucleotide position +896, downstream of the cDNA start codon, a missense mutation which leads~     to an amino acid substitution Asp299Gly in the third exon of the TLR4 gene. Pre-clinical~     studies from our laboratory have shown an association of TLR4 with ultraviolet radiation~     induced skin cancer. Hence, in this study we will assess the pattern of TLR4 polymorphisms~     and susceptibility to skin cancer.~   "
33939|NCT03122353|"~     This study will be conducted to evaluate the therapeutic bioequivalence of a TEST formulation~     of calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064% to~     the RLD.~   "
33940|NCT03122340|"~     The aim of this study is to determine efficacy and safety of polyprenols (ROPREN) using in~     patients with acute coronary syndrome~   "
33941|NCT03122327|"~     This is a multi-center, prospective, non-interventional study. Eligible newly diagnosed~     elderly multiple myeloma (MM) patients will receive comprehensive geriatric assessment (cGA)~     including ECOG scale, questionaires of ADL（activities of daily living), IADL(instrumental~     ADL),MNA-SF(mini-nutritional assessment), GDS(geriatric depression scale), MMSE(mini-mental~     state examination), SF-36 and CCI (charlson comorbidity index). Patients will get standard~     care for MM and receive the above assessments at baseline and after cycle 1, 4 and 12 for~     treating MM.Follow-up information and survival data of these MM patients would be collected.~     We would evaluate the cGA status of these newly diagnosed elderly MM patients and investigate~     the association of cGA parameters with patient's survival.~   "
33942|NCT03122314|"~     -  Currently, paracetamol and nonsteroidal antiinflammatory drugs are widely used by~          emergency physicians in Turkey for the treatment of patients with acute non traumatic~          musculoskeletal pain.~        -  The objective of the study is compare the efficacy of intravenous dexketoprofen with~          paracetamol in the treatment of acute non-traumatic musculoskeletal pain.~   "
33943|NCT03122301|"~     Vasomotor symptoms (hot flashes, night sweats, VMS) affect up to 65% of breast cancer~     survivors and negatively impact their quality of life. VMS in Hispanic women are~     significantly more severe as compared to non-Hispanic Caucasian women. Few effective~     treatments for VMS are available, especially in the underserved Hispanic and Spanish-speaking~     populations which is problematic, as Hispanics will comprise 20% of the U.S. population by~     2025. Stellate ganglion nerve block (SGB) with local anesthetic, previously performed for~     chronic pain indications, has shown promise as a potential treatment for menopausal women~     with VMS in previous clinical trials, but has not been investigated in Hispanic or~     Spanish-Speaking women with breast cancer in a controlled study.~   "
33944|NCT03122288|"~     Over 50% of adults with HIV have some form of HIV-Associated Neurocognitive Disorder (HAND)~     which represents a significant symptom that interferes with everyday functioning and quality~     of life. As adults age with HIV, they are more likely to develop comorbidities such as~     cardiovascular disease, hypertension, and insulin resistance which will further contribute to~     poorer cognitive functioning and HAND. Based upon the Frascati criteria, HAND is diagnosed~     when a person performs less than 1 to 2 SD below their normative mean (education & age) on~     measures of two or more cognitive domains (e.g., attention, speed of processing, verbal~     memory, executive functioning). Yet, from the cognitive literature and prior studies,~     administering certain computerized cognitive training programs may improve specific cognitive~     domains in older adults and those with HIV. Such cognitive training programs may be effective~     in older adults with HIV and therefore investigators may be able to change the diagnosis of~     HAND in such cognitively vulnerable adults. In this pre-post experimental study, 146 older~     adults (50+) with HAND will be randomized to be in either: 1) the Individualied-Targeted~     Cognitive Training, or 2) a no-contact control group. The investigators will focus on those~     cognitive domains in which participants express an impairment and train them with the~     corresponding cognitive program. Such an Individualized-Targeted Cognitive Training approach~     using standard cognitive training programs may offer hope and symptom relief to those~     individuals diagnosed with HAND. Furthermore, these changes may result in improved everyday~     functioning (e.g., IADLs) and quality of life. This approach represents a paradigm shift in~     possibly changing the way HAND is examined. Specific Aim 1: Compare adults who do receive~     Individualized-Targeted Cognitive Training to those who do not in order to determine whether~     a change in HAND prevalence and severity occurs between groups. Exploratory Aim 1: Compare~     adults who do receive individualized-targeted cognitive training to those who do not in order~     to determine whether this improves everyday functioning (e.g., IADLs). Exploratory Aim 2:~     Determine whether improvements in HAND and/or everyday functioning over time mediate~     improvements in quality of life.~   "
33945|NCT03122275|"~     This study aims to assess the effectiveness of a stepwise approach, with increasing~     complexity and cost, to improve adherence to organized cervical cancer screening: step 1a -~     customized text message invitation; step 1b - customized automatic phone call invitation;~     step 2 - secretary phone call; step 3 - health professionals face-to-face appointment.~      A population-based randomized controlled trial will be implemented in Portuguese urban and~     rural areas. Women eligible for cervical cancer screening will be randomized (1:1) to~     intervention and control. In the intervention group, women will be invited for screening~     through text messages, automatic phone calls, manual phone calls and health professional~     appointments, to be applied sequentially to participants remaining non-adherent after each~     step. Control will be the standard of care (invitation by written letter).~      As primary objectives, we intend to test the superiority of interventions based on step 1~     (1a+1b) and multistage interventions based on steps 1 and 2 and steps 1 to 3, based on~     intention-to-treat analyses.~   "
33946|NCT03122262|"~     This is a non-inferiority (10% non-inferiority margin), study to assess the efficacy and~     safety of dolutegravir, DTG (50 mg once daily [QD]) administered in combination with~     tenofovir alafenamide fumarate, TAF (25 mg QD) and emtricitabine, FTC (200 mg QD) compared to~     DTG (50 mg QD) administered in combination with tenofovir disoproxil fumarate, TDF (300 mg~     QD) and FTC (200 mg QD) and compared to efavirenz, EFV (600 mg QD) administered in~     combination with TDF (300 mg QD) and FTC (200 mg QD) over 96 weeks in patients with HIV-1~     starting first-line ART.~   "
33959|NCT03122093|"~     To the investigators' knowledge, no single long-term prospective observational study has~     assessed dietary factors, diabetes clinical variables (metabolic control and associated~     complications), and self -perceived health and wellness in T1D patients (both pediatric and~     adult) with CD identified by screening (positive/weakly positive serology). The aim of the~     current study is to observe the short- and long-term outcomes for Type 1 diabetic patients~     with new serology positive asymptomatic CD.~   "
33960|NCT03122080|"~     The investigators describe a protocol for a multicenter randomized controlled trial to find~     out the efficacy of electroacupuncture for depression related insomnia.~   "
33961|NCT03122067|"~     The aim of the present experiment is to examine oxytocin's behavioral and neural effects on~     social pain empathy~   "
33947|NCT03122249|"~     Nearly 20% of Americans and 41% of Iowans live in rural or non-metropolitan areas.(1) Lack of~     access to providers, long travel distances, and a disconnected health system contribute to~     increased distress and lower quality-of-life (QOL) in people with advanced cancer living in~     rural areas. (2) In the state of Iowa, 94% of rural residents have high-speed internet~     access. (3) The University of Iowa Health Care (UIHC) eHealth eNovation Center has developed~     the infrastructure to address the health care access gap in Iowa. The combination of wide~     availability of high-speed internet and the eHealth network provides an opportunity to~     develop and test interventions that leverage this infrastructure in order to address this~     important palliative care gap.~      This is a pilot study to evaluate the feasibility of an eHealth self-management intervention~     for cancer symptom management. The intervention consists of a web-application that provides~     tailored educational information about cancer symptoms and a monitoring platform to track~     symptom distress and strategies used to manage them. Participants will also receive e-visits~     from a research nurse or research assistant via UIHC eHealth and eNovation video platform.~     The purpose of this study is obtain feasibility data about the intervention for a future RCT~     and to evaluate the OASIS intervention with patients living in rural Iowa receiving treatment~     for advanced cancer. The specific aims are:~        1. to evaluate the feasibility of the OASIS intervention to self-manage symptoms of rural~          patients with advanced cancer, including a) recruitment and retention, b) use patterns,~          c) usability of each component of the intervention (i.e., the e-visit platform and the~          web-application), d) acceptability of the intervention and study (i.e., satisfaction,~          barriers and facilitators to use, burden); and~        2. to determine preliminary effects of the intervention on self-management behaviors and~          symptom severity, symptom distress, and symptom interference.~   "
33948|NCT03122236|"~     Loss of mobility and cognitive ability are serious conditions that threaten the independence~     of older adults. The objective of this study is to initiate a line of research to develop a~     novel therapeutic intervention to enhance both mobility and cognition via neuroplasticity of~     frontal/executive circuits.~   "
33949|NCT03122223|"~     A phase 1/2a clinical trial to evaluate the safety and immunogenicity of ALVAC-HIV (vCP2438)~     and of MF59®- or AS01B-adjuvanted clade C Env protein, in healthy, HIV-uninfected adult~     participants~   "
33950|NCT03122210|"~     During acute coronary syndrome, the American College of Cardiology and the American Heart~     Association recommend oxygen delivery to patients with less than 90% oxygen saturation.~     Oxygen therapy in these patients for a duration of at least 6 hours, but also stipulates that~     it is reasonable to administer oxygen to all acute coronary syndrome patients during the~     first six hours following the presentation. Hyperoxia also has well-established risks.~      Our research hypotheses are:~      (I) that current practices tend to use high oxygen flows resulting in high SpO2 levels during~     acute coronary syndrome.~      (II) there is a high rate of desaturation in patients with acute coronary syndrome and an~     automatic adaptation of oxygen flows may reduce this frequency.~      (III) that excessive oxygenation targets have no advantage. Our hypothesis is that~     maintaining a SpO2 of 90 to 94% is at least equivalent when compared to higher saturation~     objectives (SpO2 of 94 to 100%) with regard to the occurrence of complications in the patient~     in acute coronary syndrome . We will use two SpO2 targets with the FreeO2 system, 92 and 97%.~   "
33951|NCT03122197|"~     The purpose of this study is to determine the ability of letrozole to penetrate the blood~     brain barrier and concentrate in gliomas.~   "
33952|NCT03122184|"~     This is a randomized controlled pilot trial in 50 acute coronary syndrome patients to~     determine if a 12 week, telephone-delivered, combined positive psychology-motivational~     interviewing intervention is more effective than a health behavior education program at~     improving health behaviors and other outcomes. The investigators hypothesize that the~     intervention will be associated with better mental and physical health outcomes and better~     health behavior adherence compared to the health behavior education program.~   "
33953|NCT03122171|"~     The purpose of the study is to assess the effectiveness of an upper extremity prosthesis in~     improving the upper extremity function of children with cerebral palsy who have limited use~     of their hands. Twelve children, aged 4-17 years, who have cerebral palsy and limitations in~     their ability to use their hands, will be enrolled. All participants will be fitted with a 3D~     printed arm/hand prosthesis and receive 8 occupational therapy sessions. Each subject will be~     evaluated pre-treatment, post-occupational therapy sessions and at 6 months follow-up. The~     evaluation will include assessment of (1)passive and active arm/hand movement and~     (2)functional hand skills using several standardized tests. The results from the~     pre-treatment and the two post-treatment evaluations will be compared.~   "
33954|NCT03122158|"~     Escitalopram has been approved by FDA in the treatment of adolescents with major depressive~     disorder since March 2009. To date, there are only 3 clinical trials assessing the effect and~     validity of escitalopram on major depressive disorder, which of them has resulted in~     inconsistent findings. In the present study, the authors aimed to assess the effect and~     validity of this drug in the treatment of adolescents with major depressive disorder and or~     anxiety disorders.~   "
33955|NCT03122145|"~     The purpose of this study is to establish normative values for clinical testing measures of~     swallow, respiratory and cough functions. This will aide in establishing degree of impairment~     in disordered populations, and in identifying efficacious treatment paradigms for dysphagia.~   "
33956|NCT03122132|"~     The aim of the study is to evaluate in clinical practice the efficacy and safety of~     ombitasvir/paritaprevir/ ritonavir and dasabuvir administered for 8 weeks in treatment-naïve~     participants with genotype 1b hepatitis C virus (HCV).~   "
33957|NCT03122119|"~     This prospective study will be quantitatively analyzing the effectiveness of~     platelet-rich-plasma (PRP) injections into the sacroiliac (SI) joint as compared to~     corticosteroid injections and conservative management in relieving sacroiliitis and low back~     pain originating from the SI joint. The effectiveness of PRP injections on joint pain has~     been well studied in the knee and shoulder. PRP injections are performed on the SI joint~     commonly, but there is little research documenting their effectiveness when compared to other~     interventions. This study will be a small pilot study to aid in closing this knowledge gap.~     Additionally, these injections will be performed under ultrasound guidance. Ultrasound has~     been proven to be of equal reliability to fluoroscopy and has the advantage of shorter time~     to administer and no radiation. There will be three arms to this study. The first will be a~     control arm, the second will be an active comparator arm which is the corticosteroid~     injection, and the third is the experimental arm consisting of PRP injection. The~     corticosteroid and PRP will be injected into the joint using the exact same technique via~     physical exam, special tests, and ultrasound guidance. The only difference between the two~     arms is the substance to be injected. The outcomes will be measured with the Numeric Rating~     Scale for Pain (NRS) and the Oswestry Disability Index (ODI) prior to the injection,~     immediately post-injection, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, and 1 year~     post-injection. The investigators hypothesis is, Platelet-Rich Plasma Injections in the~     Sacroiliac Joint using ultrasonography in conjunction with physical examination and Point of~     Maximal Tenderness will produce statistically significant pain relief for more than 3 months~     as measured by the Numeric Rating Scale for Pain (NRS) and Oswestry Disability Index (ODI).~   "
33958|NCT03122106|"~     This is a phase 1 open-label study to evaluate the safety and immunogenicity of a neoantigen~     DNA vaccine strategy in pancreatic cancer patients following surgical resection and adjuvant~     chemotherapy. The neoantigen DNA vaccines will incorporate prioritized neoantigens and~     personalized mesothelin epitopes and will be administered with an electroporation device. The~     hypothesis of this study is that neoantigen DNA vaccines will be safe and capable of~     generating measurable neoantigen-specific CD4 and CD8 T cell responses.~   "
33962|NCT03122054|"~     This study examines complications, mortality rates, cost-effectiveness and safety of early~     laparoscopic cholecystectomy (ELC) versus delayed laparoscopic cholecystectomy (DLC). Group L~     (n:88) patients treated surgically with laparoscopic cholecystectomy immediately or Group D~     (n:88) patients first treated medically and than treated surgically with delayed (4-8 weeks~     later) laparoscopic cholecystectomy.~   "
33963|NCT03122041|"~     Metformin is the first-line therapy for PCOS with high metabolic risk, yet a large proportion~     of patients cannot tolerate it due to associated gastrointestinal adverse events. The~     alternative pharmacological strategy when metformin cannot be tolerated is not well~     established in this population. Our aim was to evaluate whether sitagliptin (SITA) preserves~     metabolic profile in metformin (MET) intolerant PCOS with high metabolic risk.~   "
33964|NCT03122028|"~     The aim of the study LA-EU-01 was to examine the safety and the feasibility of the LAmbreTM~     Left Atrial Appendage Closure System in patients with non-valvular paroxymal, persistent or~     permanent atrial fibrillation, by using imaging approaches, i.e. combined trans-esophageal~     and transthoracic echocardiography.~      The conducted LA-EU-01 study was a prospective, non-randomized, multi-center, open-label,~     non-comparative, interventional clinical investigation with the participation of two clinical~     centers in Germany and the inclusion of 61 subjects.~      Participating subjects were patients with non-valvular paroxymal, persistent or permanent~     atrial fibrillation with long-term sustainability and scheduled for interventional closure of~     the left atrial appendage who could not be treated with anticoagulation.~      After the procedure of implantation of the LAmbreTM Left Atrial Appendage Closure System,~     patients underwent a first follow up assessment prior to hospital discharge then at 30 days,~     6 and 12 months.~   "
33965|NCT03122015|"~     Children in hospitals are frequently subjected to painful procedures, including those~     involving needles, which are a common source of pain in children. In addition, procedural~     pain and anxiety can lead to various consequences for the child, as well for the parent and~     the nurse performing the procedure. The use of physical and psychological interventions is~     recommended for optimal relief of procedural pain. Moreover, these interventions can be used~     alone or in combination with pharmacological treatment. Although several analgesics exist and~     are used in clinical practice, nonpharmacological interventions aimed at the psychological~     component of pain are not well known and are not always used by the nurses in the pediatric~     practice. Distracting interventions are widely studied in the literature as it is an~     effective psychological intervention in the relief of pain and anxiety in children during~     needle-related pain procedures. The distraction by the therapeutic clown is a multi-modal~     intervention with multi-sensory effects and appears promising in pain relief and procedural~     anxiety, but not much studies have been done in the context above. The therapeutic clown can~     adapt to the age of the child, its culture, its reality of care and can prepare the child for~     painful procedures. The aim of this study is to assess the feasibility, acceptability and~     preliminary effects of distraction by therapeutic clown on pain and anxiety of children aged~     two to 17 years and the level of anxiety of the parents and nurses during a painful procedure~     in children.~      OBJECTIFS AND QUESTIONS:~        1. Assess the feasibility and acceptability of distraction by therapeutic clown with~          children during painful procedures. a) Is the distraction intervention by the~          therapeutic clown feasible and acceptable during painful procedures?~        2. Assess the preliminary effects of distraction by therapeutic clown on pain and anxiety~          of children and the anxiety of parents and nurses. a) What are the preliminary effects~          of the therapy clown distraction on children's pain and anxiety, and the anxiety of~          parents and nurse.~   "
33966|NCT03122002|"~     Through 5 years continuous observation of acute ischemic stroke patients in Neurology~     Department of Tongji Hospital, Tongji Medical College of Huazhong University of Science and~     Technology, clinical data about emergency treatment (neurological score, examination and~     treatment), medical data after admission (neurological score, inspection, examination and~     treatment) and long-term prognosis (neurological score) was collected. The outcomes were set~     as the score scale, all blood test index and examination index of the research objects at~     specific period after illness. Through statistical analysis and comparison of different~     in-hospital clinical data in predicting the outcome of the patients, our study will provide~     more evidence-based solutions for the treatment and prediction of acute ischemic stroke.~   "
33967|NCT03121989|"~     Breast cancer is the second most common form of cancer in women and the most frequent cause~     of death. Despite breast screening programs, a substantial number of women are diagnosed with~     cancers greater than 2 cm in size or locally advanced disease, which is best treated with~     neoadjuvant chemotherapy (NAC) prior to surgery. Approximately 10% of women diagnosed with~     breast cancer annually will have locally advanced breast cancer, defined as stage III~     disease, where the cancer has either spread to regional lymph nodes and/or other tissue in~     the area of the breast, but not to distant sites. NAC offers the advantages of downstaging~     the disease, potentially reducing the extent of surgery. Presently, gadolinium enhanced MRI~     is the standard test used to monitor disease response to chemotherapy, and demonstrates~     changes in tumour size and extent between pre-NAC and post-NAC. Unfortunately, changes in~     tumour size may occur late in treatment regimen, thus producing false-negative results on~     early magnetic resonance imaging (MRI). Therefore, newer imaging techniques beyond anatomical~     imaging are needed to identify tumours that are unresponsive to chemotherapy and potentially~     change treatment plan early on to avoid significant morbidity associated with prolonged~     chemotherapy.~      A novel MRI technique utilizing hyperpolarized pyruvate has the potential to detect~     pathophysiological response early in the treatment regimen and would therefore allow for~     earlier identification of nonresponders and subsequent early modification of treatment~     regimens, if necessary.~   "
33968|NCT03121976|"~     The purpose of this study is to determine which technique for catheter placement in~     continuous femoral nerve block (FNB) is most successful - guidance with (1) ultrasound or (2)~     nerve stimulation and ultrasound. Sensory and motor assessment scores will be obtained~     post-FNB. Patient controlled analgesia and opiate consumption is also recorded along with~     pain scores for the first 48 hour post-FNB.~   "
33969|NCT03121963|"~     Our study aims to see if the addition of a scheduled non-opioid pain regimen will decrease~     the use and risk of opioid pain medications as well as improve pain control in head and neck~     surgery patients. Participants will be randomized to one of two pain regimens (opioid~     medication regimen vs combination regimen of opioid and non-opioid medications).~   "
33970|NCT03121950|"~     The goal of the study is to learn about how possible benefits of movement and music for~     individuals with dementia. Individuals with dementia will participate in either a dance class~     or listen to live music. The study includes assessments of walking, balance and cognition.~   "
33971|NCT03121937|"~     This study aims to evaluate a technology-based treatment support system for patients~     undergoing the treatment of depression. The investigators will explore the usefulness of the~     technology-based treatment support system as an adjunct to psychotherapy for depression.~   "
33972|NCT03121924|"~     Analyze the effect of preincubation time of oocyte on the results of ICSI in a oocyte~     donation model.~   "
34010|NCT03121430|"~     Evaluation of drug eluting peripheral vascular stent system for the treatment of superficial~     femoral artery stenosis and / or occlusion, there is better in effectiveness and clinical~     performance compared with similar products already on the market.~   "
33973|NCT03121911|"~     Introduction: Expiratory flow limitation (EFL) and ventilatory inefficiency during dynamic~     exercise have been identified in patients with recent myocardial infarction (RMI) with~     preserved ventricular and pulmonary function. However, it is not known what is the prevalence~     of EFL in this population and what are the effects of physical and respiratory training on~     this limitation.~      Objectives: To evaluate the prevalence of EFL and ventilatory inefficiency during dynamic~     exercise in individuals with uncomplicated RMI, and to evaluate the effects of interval~     physical training (IT) in addition to inspiratory muscle training (IMT), exclusive IT and~     absence of cardiopulmonary rehabilitation (CR) on EFL and ventilatory efficiency.~      Methods: 54 patients will be included, divided into three groups with 18 participants each.~     All will be submitted to evaluations of heart rate variability, hematological and biochemical~     profile, erythrocytes membrane deformability and stability, inflammatory markers, respiratory~     pressures, plethysmography, spirometry, carbon monoxide diffusion capacity, ankle brachial~     index, electrical bioimpedance, echocardiogram, quality of life questionnaires,~     cardiopulmonary exercise testing and constant load tests. Then, groups 1 (IT) and group 2 (IT~     + IMT) will participate in a physical training program for 12 weeks and will be re-evaluated~     after this period. In addition, they will be monitored for a 6 month period after discharge,~     with returns every two months to measure the energy expenditure through an accelerometer, and~     at the end of this period they will repeat all the tests again. Group 3 (absence of CR), will~     consist of patients who do not live in the city or those who can not participate in the CR~     program for any other reason, and will only participate in the evaluations.~   "
33974|NCT03121898|"~     Prospective cohort study on adult cardiac surgery patients. Platelet function evaluated~     before and after cardiopulmonary bypass. Bleeding and transfusion recorded. Primary endpoint~     is finding the association between postoperative platelet function and bleeding.~   "
33975|NCT03121885|"~     The aim is to define in detail metabolic pathways at rest and during aerobic exercise in~     normal and healthy men and women under normobaric normoxic and moderate hypoxic conditions,~     using metabolomics technologies based on minimally invasive sampling relying on gas~     chromatography and mass spectrometry.~   "
33976|NCT03121872|"~     Objective: Titanium-prepared platelet-rich fibrin (T-PRF) is activated with titanium, which~     results in a more mature and aggregated form than PRF. In our previous studies, we~     established that the fibrin carpet formed with titanium had a firmer network structure, and~     longer resorption time in the tissue than the fibrin carpet formed with glass. The purpose of~     this randomized controlled clinical trial is to compare the effects of autogenous T-PRF and~     CTG.~      Materials and methods: A total 114 Miller Class I/II gingival recessions with abrasion~     defects will be treated either T-PRF (63 teeth) or CTG (51 teeth) using a modified tunnel~     technique. Clinical periodontal indexes, keratinized tissue (KTW), gingival thickness (GT)~     and recession depth (RD) will be recorded before surgery and at 6 and 12-month follow-up~     examinations. The Visual Analog Scale and healing index scores will be assessed.~   "
33977|NCT03121859|"~     Does the use of analgesic current therapies increase the effectiveness of neck stabilization~     exercises for improving pain, disability, mood, and quality of life in chronic neck pain? a~     randomized, controlled, single-blind study~   "
33978|NCT03121846|"~     This is a Prospective, Open-label, Single-Arm, Multi-center phase II clinical trial~     evaluating the efficacy and safety of Apatinib for Chemotherapy Failure Ⅳ Stage Soft Tissue~     Sarcoma.~   "
33979|NCT03121833|"~     This is a randomized, double-blind, placebo-controlled (2: 1), multicenter clinical phase II~     clinical trial evaluating the efficacy and safety of Endostar combined with chemotherapy for~     stage IV soft tissue sarcoma.~   "
33980|NCT03121820|"~     This study are two-way crossover, open-label, single-dose, fasting, bioequivalence study of~     Memantinol® (JSC GEROPHARM, Russia) 20 mg tablets versus Akatinol Memantine® (Merz Pharma~     GmbH & Co. KGaA, Germany) 20 mg tablets in normal healthy subjects~   "
33981|NCT03121807|"~     This survey is a single arm study to assess the effect of home parenteral nutrition on~     overall survival, cycles of salvage chemotherapy completed, side effects of salvage~     chemotherapy, quality of life, nutritional status, functional status, inflammatory status and~     complications of HPN in malnourished unresectable metastatic gastric cancer (mGC) patients in~     a single medical center. It is expected that about 20 subjects will be recruited during an~     estimated period of 48 months.~   "
33982|NCT03121794|"~     Evaluate whether discrete landmarks of the proximal humerus can be identified using~     ultrasound in patients with various body habitus and BMI.~   "
33983|NCT03121781|"~     Preterm babies have immature lungs and frequent pauses in their breathing which often~     necessitates breathing support. Nasal Continuous Positive Airway Pressure (nCPAP) is one of~     the most commonly used tools, but the standard interfaces (prongs or mask) may cause~     nasal-septal injury and discomfort.~      The RAM cannula is another interface that consists in soft and curved prongs to avoid this~     nasal injury, but as the seal is not 100%, suboptimal delivery of airway distending pressure~     could result if they are used to deliver CPAP, as compared to standard interfaces.~      The investigators plan to study very low birth weight preterm babies who are generally well~     but require some support with their breathing. By inserting a special feeding tube with~     sensors into the stomach, the investigators can measure the electrical activity of the~     diaphragm (EAdi), which is an important muscle for breathing. By analyzing EAdi in babies~     receiving nCPAP either with prongs or ram cannula, the investigators will be able to measure~     and compare how each method of support affects a baby's breathing. This important study will~     help us determine the most appropriate breathing support for preterm babies.~   "
33984|NCT03121768|"~     A prospective observational study to re-establish a new prognostic model for predicting the~     outcome in patients with non-muscle invasive bladder cancer (NMIBC) using the current~     recommendation regimen for intermediate and high risk groups and including all potential and~     highly prognostic factors.~   "
34011|NCT03121417|"~     This phase II trial is studying blood and tumor tissue from patients with advanced non-small~     cell lung cancer who are treated with nivolumab to better understand how nivolumab works.~     Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to~     grow and spread by turning on the immune system (T cells). We want to study the effects of~     nivolumab on the immune system (T cells) by collecting blood samples and samples from~     patients' tumors.~   "
33985|NCT03121755|"~     The type 1 cholecystokinin receptor (CCK1R) is a potential target for the treatment of~     obesity, due to the ability of this GI hormone to elicit satiety. However, this receptor has~     been shown to be sensitive to the cholesterol content of the membrane in which it is~     expressed. Because some patients who might be candidates for the use of CCK agonists to treat~     their obesity and co-morbidities, the goal of this study is to determine how metabolic~     abnormalities might affect the responsiveness of this receptor to CCK. Because the normal~     site mediating CCK-stimulated satiety is on vagal afferent neurons that cannot easily be~     studied, we will collect buffy coat cells from a peripheral blood sample from patients~     involved in the Sangre Por Salud Biobank at Mountain Park Medical Center. Ex vivo, the CCK1R~     will be expressed on these cells and will be functionally characterized, and the cholesterol~     content of the cells will be assayed. These data will be correlated with the clinical,~     biochemical, and metabolic phenotypic data collected as part of the parent study.~   "
33986|NCT03121742|"~     Suicide is the most common form of deadly violence. Indeed, since more than 40,000 people die~     by suicide each year, people are 2.5 times more likely to die by their own hand than someone~     else's. The four weeks after discharge from inpatient care is an especially dangerous period~     in terms of suicide risk, possibly because of poor post-discharge treatment adherence and~     poor treatment efficacy during a suicide crisis. To reduce suicide risk both in general and~     during the post-discharge period, interventions are needed that (1) are easily adhered to and~     (2) are effective during a suicide crisis. The goal of the study is to pilot-test a suite of~     five smartphone-based ecological momentary interventions (EMI) that can be easily used during~     a suicide crisis. Two target hopelessness, two target loneliness, and one targets negative~     automatic thoughts associated with hopelessness and loneliness. Although these interventions~     are new to the study of suicide, they are all grounded in decades of empirical work and~     adapted from effective interventions in areas relating to suicide.~      Participants will be 20 inpatients (n = 10 each in treatment as usual [TAU] plus intervention~     and TAU plus assessment [i.e., control] groups) from the Massachusetts General Hospital~     Inpatient Psychiatric Service. The investigators hypothesize that those in the TAU plus~     intervention group will have lower levels of suicidal ideation during the inpatient and~     post-discharge period than those in the TAU plus assessment group.~   "
33987|NCT03121729|"~     This study is aimed to evaluate the safety of applying enhanced recovery after surgery for~     gastric cancer.~   "
33988|NCT03121716|"~     This is an open-label, single center, non-randomized, phase I trial to evaluate safety and~     efficacy of using the combination treatment of SHR-1210, gemcitabine and cis-platinum by~     recurrent and metastatic NPC.~   "
33989|NCT03121703|"~     Purpose: The purpose of this study is to investigate the effects of lumbar stabilization~     exercises on pain intensity, transversus abdominis muscle (TrA) activation capacity,~     functional disability, and TrA thickness in patients with chronic low back pain (CLBP).~     Subjects: The subjects of this study were 30 CLBP patients. Methods: The experimental group~     performed diverse lumbar stabilization exercises in different postures, and the control group~     conducted an ordinary trunk muscle strengthening exercise. Results: There were significant~     differences in pain intensity, TrA activation capacity, functional disability, and TrA~     thickness between before and after the intervention in both groups. Significant differences~     between the two groups were shown in the pain intensity, TrA activation capacity, and~     functional disability after the intervention. However, there were no significant differences~     between the two groups in TrA thickness. Conclusion: Lumbar stabilization exercises in~     different postures could reduce pain, functional disability, and increase TrA activation~     capacity and thickness in CLBP patients.~   "
33990|NCT03121690|"~     Cross sectional randomized clinical trial study will be done at Respiratory intensive care~     unit and Chest department at Assiut University Hospitals on All patients who developed~     hospital acquired pneumonia including ventilator associated pneumonia through two years~     duration to assess the prognostic value of different severity scores including (PSI, CURB65,~     SMART COP, IDSA/ATS and SOAR) in patients with HAP, assess platelet count as a marker for~     severity, evaluate efficacy and safety of adjuvant systemic steroids in patients with severe~     conditions and measurement of cortisol level to assess steroid response before~     administration.~   "
33991|NCT03121677|"~     Follicular lymphoma (FL) has a number of effective standard of care therapies; however, FL is~     not currently considered curable. Therefore, designing well tolerated therapies without~     cumulative and long-term toxicity is critical. This is a pilot safety and feasibility study~     that combines a personalized synthetic long peptide vaccine with nivolumab for the treatment~     of FL. Patients who demonstrate progression on this study will be treated with rituximab (or~     another monoclonal antibody against CD20) in addition to vaccine therapy with nivolumab.~   "
33992|NCT03121664|"~     The purpose of this study is to evaluate the impact of CYP3A4 inhibitor, itraconazole, on~     plasma concentration of PF-06649751 in healthy subjects~   "
33993|NCT03121651|"~     This is a pilot study to develop a reinforcement learning (RL)-adaptive visual and~     interactive support application (hereafter RL-adaptive support) to help young adults with~     spina bifida or cerebral palsy become more independent with medication management.~     Individuals with disabilities who are empowered to manage several aspects of their lives can~     ultimately be better integrated into and contribute more to society.~   "
33994|NCT03121638|"~     -  Indication: Protection against varicella and herpes zoster~        -  Study Objectives~             -  Primary: Safety and tolerability assessment after single dose administration of~               NBP608~             -  Secondary: immunogenicity assessment after single dose administration of NBP608~   "
33995|NCT03121625|"~     This is an open, single-arm, phase I clinical study to evaluate efficacy and safety of~     chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of hematopoietic and~     lymphoid malignancies. A total of 30 patients are planned to be enrolled over a period of 2~     years.~   "
33996|NCT03121612|"~     The study aims to assess the basic functionality of a newly designed CPAP machine with~     reusable circuits to existing machines with disposable circuits, for treatment of newborn~     infants diagnosed with respiratory distress syndrome. The assessment will compare a~     comprehensive list of physiological parameters over the first 72 hours of treatment, and will~     also monitor rates of side effects and adverse events. The null hypothesis is that infants~     treated on the two categories of machine (reusable vs disposable) will not differ in relation~     to key physiological parameters by more than 0.63 standard deviations.~   "
33997|NCT03121599|"~     The Main purpose of this project to study the uptake pattern of FLT-PET and it is value in~     assessing the malignant hematopoiesis in MPN within the pediatric age group, in terms of~     diagnosis, staging and monitoring response to therapy. As well as, evaluating FLT-PET as a~     novel non-invasive technique in cases with MPN and its role in comparison to the standard~     bone marrow biopsy with regard to disease diagnosis, assessment of disease activity,~     detection of transformation, monitoring of treatment response and grading of~     fibrosis.Furthermore, we aim to study the association of FLT-PET uptake patterns with~     different genetic makeup (JAK2, CALR positive, MPL, or Triple negative disease) or allele~     burden in cases of Pre-PMF with the ability of FLT-PET to differentiate between Pre-PMF and~     ET.~      Although MPNs are diseases of elderly, MPN is diagnosed in younger age groups in a~     considerable number of cases. Since most of the available data as well as current WHO~     classification criteria emphases on the average MPN patients who range in age between 55~     and 65 years. Less consistent data are available in the groups of patients presenting below~     this median age, such as children and younger adults which we're planning to reveal.~   "
33998|NCT03121586|"~     To evaluate the long-term safety and tolerability of pimavanserin after 52 weeks of~     adjunctive treatment in subjects with schizophrenia~   "
33999|NCT03121573|"~     The aim of this study was to investigate the effects of duloxetine on improvement of brain~     cortical activity in patients suffering from major depressive disorder using near infrared~     spectroscopy.~   "
34000|NCT03121560|"~     Menorrhagia is frequent and occur in 11 to 13 % of the general population. It accounts for~     20% of the gynecological consultations and tends to increase with age. It can be the first~     symptom of a mild uterine disease or cancer (cervical or endometrial), especially if the~     patient is older. The most common causes are polyps, adenomyosis, fibroids, hyperplasia and~     cancer.~      Menorrhagia needs to be investigated -especially after menopause, when the prevalence of~     endometrial cancer is higher (10-15%). For premenopausal metrorrhagia, the assessment will be~     made if a pathology is suspected or if there is no response to the medical treatment within 3~     to 6 months.~      The medical check-up consists in the first instance in a questionnaire, a clinical~     examination and an endovaginal ultrasound examination. If the endometrium is thickened, a~     focal pathology is suspected, or if the bleeding persists despite a normal endovaginal~     ultrasound result, further examinations including a possible biopsy are required.~      While hysteroscopy is widely accepted as a standard examination for uterine cavity~     exploration, a meta-analysis showed that the diagnostic performance of hysterosonography was~     equivalent. Both are carried out on an outpatient basis during a gynecological consultation~     and require no special preparation. Several studies seem to show that hysterosonography is~     less painful, causes less discomfort and is therefore more accepted by patients than~     hysteroscopy. This is why many practitioners continue to prefer it to hysteroscopy and~     associate it with the Pipelle of Cornier for the assessment of postmenopausal metrorrhagia.~      However, if endometrial cancer is confirmed, the histological type detected within the biopsy~     is the main predictor of the severity of the disease and the treatment to be given. It is~     therefore essential to have an accurate biopsy sampling prior to therapeutic management. It~     is not the case with blind biopsies (without visual control). Indeed, some studies showed~     that the concordance between the optical aspect of the endometrium under hysteroscopy and the~     histological result was close to 90%, validating the hypothesis of an improved sensitivity~     through visual control.~      The American College of Obstetricians and Gynecologists (ACOG) currently recommends an~     endovaginal ultrasound assessment followed by an endometrial biopsy in the event of a~     thickened endometrium or when a pathology is suspected. A biopsy can even be taken during the~     consultation, at the onset of the complaints. The last recommendations of December 2010 leave~     the choice to clinicians regarding the histological diagnostic modalities (a blind biopsy~     with the Pipelle of Cornier or a targeted biopsy under hysteroscopy), although the biopsies~     under hysteroscopy are recommended since 2015. However, despite its poor sensitivity, the~     most widely used technique in the world is the blind biopsy by aspiration performed after~     vaginal ultrasound or hysterosonography because it is an easy low cost method.~      The development of hysteroscopes with a smaller diameter and the introduction of the~     vaginoscopy have considerably increased the tolerance of this examination. In addition,~     hysteroscopy allows a simultaneous therapeutic intervention for certain indications, which is~     comfortable and well accepted by the patients. Unfortunately, there are few studies comparing~     the tolerance of the two examinations performed according to the current recommendations of~     good practice of hysteroscopy. Only one comparative randomized study in 2008 showed that~     saline infusion sonography (SIS) was less painful than hysteroscopy with vaginoscopy.~     However, direct comparison was impossible since women only had one of the two examinations.~      The Brugmann University Hospital set up a consultation called one stop bleeding clinic in~     which the two examinations are performed for each patient with abnormal bleedings, in order~     to increase diagnostic performance.~      All included patients will thus undergo a saline infusion sonography (SIS) and a hysteroscopy~     (HSC). Each procedure will be evaluated on pain level (EVA scale) and tolerance by the~     patient.~   "
34001|NCT03121547|"~     While the analgesic effects of opioids are well known, evidence suggest that there are~     differences in the adverse dizziness of the different opioid types, which may influence the~     gait function differently. However, this has not been investigated scientifically under~     controlled conditions. Normal gait function is characterized by cyclic movements with a high~     degree of predictability. As such, the amount of kinematic variability can provide important~     information about a condition or an intervention that may affect the gait function .~     Three-dimensional gait analysis is a recognized method to assess changes in stride-to-stride~     variability associated with a medical condition or caused by an intervention. Thus, opioid~     induced changes in gait variability, and possible differences between opioid types, can be~     assessed objectively from differences in the variability of movements obtained from a~     three-dimensional gait analysis.~      The purpose of this study is to investigate differences in gait variability induced by two~     different single-dose opioid formulations and an inert placebo in healthy volunteers and knee~     osteoarthritis patients.~   "
34002|NCT03121534|"~     The goal of this clinical research study is to learn if blinatumomab can help to control~     Richter Transformation (RT, a type of blood cancer). The safety of this drug will also be~     studied.~      This is an investigational study. Blinatumomab is FDA approved and commercially available for~     the treatment of acute lymphoblastic leukemia (ALL). It is investigational to use~     blinatumomab to treat patients with RT. The study doctor can explain how the study drug is~     designed to work.~      Up to 21 participants will be enrolled in this study. All will take part at MD Anderson.~   "
34003|NCT03121521|"~     Introduction. Statins are generally well tolerated but not devoid of side effects. Quite~     often it is manifested by asymptomatic increase in the level of aspartate and alanine~     aminotransferase. In such cases patients to administer hepatoprotective drugs, but most of~     them used for this purpose are ineffective. The aim of this study was assess the usefulness~     of melatonin in counteracting the adverse hepatic events from statins. Methods. The research~     program included 60 patients(aged 47-65 years, 41 women and 23 men)with hyperlipidemia taking~     atorvastatin or rosuvastatin in dose 20-40 mg daily. The patients were randomly allocated in~     two groups. Group I (n=30) was recommended to take the same statin at a standardized daily~     dose of 20 mg together with melatonin at a dose 2 x 5 mg, at 7:00 and 21:00. In group II~     (n=30) patients took statins with placebo at the same time of the day. Follow-up laboratory~     tests (AST, ALT, GGT, ALP, cholesterol, triglycerides) were evaluated after 2,4 and 6 mounts~     of treatment.~   "
34004|NCT03121508|"~     The program will consist of diabetes self-management sessions, led by an occupational~     therapist. The sessions will be held in an individualized format. Sessions will focus on~     diabetes education, self-management education, and education on behaviors and adaptive~     techniques to optimize participation in daily life with type II diabetes. As occupational~     therapists, the investigators and facilitator, aim to focus on establishing healthy habits,~     roles, and routines for individuals with type 2 diabetes.~   "
34005|NCT03121495|"~     It is estimated that there are about 1.4 million patients with colorectal cancer (CRC)~     worldwide, with a rising trend in CRC incidence in many Asian Pacific countries. In Hong~     Kong, colorectal cancer ranks first in cancer incidence and second in cancer mortality based~     on data from 2013.~      CRC is one of the most preventable cancers because its development in general follows an~     adenoma-carcinoma sequence. Adenomas are considered precursor lesions for CRC.~      While early detection and removal of colorectal adenoma by screening colonoscopy with~     polypectomy reduce CRC incidence and mortality, interval cancers (cancers that develop after~     a colonoscopy and before the next scheduled colonoscopy) may still occur and were reported to~     account for up to 10.5% of CRC. The protective effect of colonoscopy against cancer in the~     right colon has not been consistently demonstrated. Interval CRC has been associated with~     proximal colon location, small lesion, flat lesion, missed lesion, inadequate examination,~     incomplete resection of lesion, tumor biology, and low adenoma detection rate (ADR).~      High ADR (eg, ≥ 20%) has been associated with a reduced risk of interval CRC. Methods that~     can improve polyp detection in the right colon such as retroflexed examination of the right~     colon, second forward view examination of the right colon, use of colonic fold flattening~     device, colonoscope with an increased field of view may potentially reduce the risk of~     interval CRC, but data is still limited. Performance of a second forward view (SFV)~     examination of the right colon may be the easiest and safest from a practical standpoint when~     compared to other options (eg, additional training is often needed for retroflexed~     examination of the right colon since there may be a potentially higher risk of perforation in~     endoscopists not familiar with the technique, additional equipment is needed when using a~     colonic fold flattening device, or a colonoscope with an increased field of view).~      Our current study aims to determine whether a routine SFV examination in the right colon can~     lead to an increase in adenoma / polyp detection when compared to conventional withdrawal~     examination in the right colon in both male and female patients undergoing screening and~     surveillance colonoscopies.~   "
34006|NCT03121482|"~     Prospective multicenter randomized controlled open-label trial comparing 2 strategies of~     oxygenation during the post-extubation period in ICU patients at high risk of extubation~     failure. Patients will be randomized and assigned to one of the two groups, with a 1:1 ratio.~   "
34007|NCT03121469|"~     Phase 1/2 study, open, monocenter, non-randomized~   "
34008|NCT03121456|"~     Open-label, multicenter, uncontrolled and non-randomized study comparing 18F-FDG PET-Scan and~     diffusion MRI in the assessment of the early therapeutic response of Diffuse Large B-Cell~     Lymphoma.~   "
34009|NCT03121443|"~     The association between patient positions including supine,prone, trendelenburg,reverse~     trendelenburg,45 degrees back up sitting position, 45 degrees legs lifted supine position and~     perfusion index.~   "
34012|NCT03121404|"~     Cirrhosis is characterized by loss of muscle as well as fat mass, which increases morbidity~     and mortality before, during, and after liver transplantation. A common mechanism for the~     reduced muscle and fat mass in cirrhosis is an increased expression of the TGF (transforming~     growth factor)beta superfamily member, myostatin, in the muscle and adipose tissue. The~     present study will examine the expression of myostatin, its receptor and intracellular~     signaling pathways in the skeletal muscle and mesenteric adipose tissue in cirrhotic patients~     undergoing liver transplantation as compared to healthy controls undergoing planned abdominal~     surgery. 16 cirrhotic patients will be identified from the transplant list, and 16 healthy~     controls from outpatient surgery lists. Nutritional assessment will be performed, including~     anthropometry (triceps skinfold thickness, mid arm circumference), dual energy x-ray~     absorptiometry (DEXA), and bioelectrical impedance analysis (BIA). Rectus abdominis muscle~     tissue and omental fat tissue will be harvested in the operating room, and the expression of~     signaling proteins involved in skeletal muscle protein synthesis will be quantified. The~     investigator will also quantify the expression of genes involved in lipolysis and lipid~     synthesis. The investigator anticipates that the expression of myostatin will be higher in~     the skeletal muscle and adipose tissue of cirrhotics as compared to controls. There will be a~     reduction in the expression of the signaling proteins that regulate skeletal muscle protein~     synthesis, as well as the expression of genes regulating lipogenesis. The increased~     expression of myostatin will also correlate with reduced anthropometric and DEXA measurements~     of lean body mass and fat mass.~   "
34013|NCT03121391|"~     The proposed study is an important, under-investigated area of ICU care for terminally ill~     patients undergoing terminal ventilator withdrawal. The proposed research has relevance to~     public health because an algorithmic approach to the ventilator withdrawal process will~     enhance clinicians' ability to conduct the process while assuring patient comfort, using~     opioids and/or benzodiazepines effectively.~   "
34014|NCT03121378|"~     The aim of the study is to assess blood platelet function and activation in patients~     undergoing both cement and non cement hip joint total alloplasty. Bone cement is used as a~     special biomaterial to help fix a hip prosthesis in place but is associated with bone cement~     implantation syndrome causing such complications as hypotension, cardiac arrhythmias. The~     pathophysiology of bone cement implantation syndrome is not fully known but one theory~     supports formation of clots in the bloodstream. This directly would activate platelets but no~     such study has been performed in humans. As bone reaming could potentially cause platelet~     activation even without bone cement, the study involves a control group of patients~     undergoing non cemented joint alloplasty.~   "
34015|NCT03121365|"~     This study evaluates the effects of digital versus standard literacy promotion, as well as~     dialogic language behaviors and reading comprehension among infants when comparing the use of~     e-books to standard board books. Around half of the participants will receive standard board~     books at the 6, 9, and 12 month well visits, while the other half will receive digital~     e-books.~   "
34016|NCT03121352|"~     The purpose of this study is to see how effective the combination of the two chemotherapy~     drugs (carboplatin and nab-paclitaxel) are when added to a third drug, pembrolizumab.~      Pembrolizumab is an investigational (experimental) drug that works by reinvigorating the~     immune system, allowing it to target and destroy cancer cells. Pembrolizumab is experimental~     because it is not approved by the Food and Drug Administration (FDA) for this type of breast~     cancer treatment.~   "
34017|NCT03121339|"~     This is a phase 1 open-label pharmacodynamics study in healthy adults. The purpose of the~     study is to determine if the tablet formulation size of VXA-A1.1, an adjuvanted adenoviral~     based influenza vaccine, has an impact on delivery location. The secondary objective is to~     evaluate delivery with fasting versus fed status.~   "
34018|NCT03121326|"~     With the rapid growth of the global elderly population, the studies of the biomarkers of the~     sarcopenia and aging are under investigation in different ways. The investigators use~     Metabolomics to explore the biomarkers of the sarcopenia and aging of the senior adults.~   "
34019|NCT03121313|"~     Primary Objective:~      To determine the 2-year distant failure rate of maintenance tegafur-uracil in patients with~     squamous cell carcinoma of oral cavity with extracapsular spreading of lymph nodes.~      Secondary Objectives:~        -  To determine the 2-year locoregional failure rate.~        -  To evaluate the 2-year overall survival (OS) rate.~        -  To evaluate the 2-year progression-free survival (PFS) rate.~        -  To assess the safety profiles.~   "
34020|NCT03121300|"~     Little is known about the safety of body radiation therapy (SBRT), especially the impact on~     pulmonary function, quality of life, and on functional changes within the lung itself.~     Radiation dose constraints and capturing functional changes on imaging are not well studied~     in this setting.~      The current study aims to evaluate the utility of advanced imaging to measure lung function~     prior to and after treatment and to assess the feasibility of using this data to adapt SBRT~     planning.~   "
34021|NCT03121287|"~     The purpose of this study is to investigate if cardiac MRI, blood biomarkers, and lung CT~     scans can detect early changes to the associated with radiation therapy in patients receiving~     radiation treatment for thoracic cancer.~   "
34022|NCT03121274|"~     Nulliparous women in spontaneous or induced labour with term singleton pregnancy are~     randomized into two groups first group (early pushing) in this group patients were allowed to~     push within one hour after full cervical dilatation whether the vertex was visible or not.~     Second group (delayed pushing) patients here were asked not to push for maximum of 3 hours or~     start pushing when the vertex was visible.~   "
34023|NCT03121261|"~     The cutaneous silent period is a non-invasive technique that gives insight into the function~     of thin A delta fibers and as such can be a complement to conventional electrophysiological~     methods used to study the peripheral nerves. Clonidine is a selective partial agonist of the~     alpha-2 receptors which, added intrathecally to levobupivacaine, enhances the effect of a~     local anesthetic, prolongs sensory and motor block during local anesthesia and extends the~     length of post-operative analgesia. It is believed that clonidine achieves this effect by~     activating the postsynaptic alpha-2 receptors in the gelatine substance of the spinal cord~     and blocking the conduction of A-delta and C fibers. The aim of the study is to examine~     functional changes of Aδ - fibers during the application of spinal anesthesia by measuring~     the cutaneous slinet period and compare the effect of intrathecal administration of a~     combination of local anesthetic and clonidine in the quiet skin period in relation to the~     application of local anesthetic only.~   "
34024|NCT03121248|"~     This study will evaluate the effect of highly accelerated external beam radiotherapy (EBRT)~     in 5 fractions over 10 days compared to 15 fractions over 3 weeks for early as well as~     locally-advanced stage breast cancer.~      Primary endpoint will be chronic toxicity (breast deformation and retraction). Secondary~     endpoints are acute toxicity, loco-regional and distant tumor control, patient reported QoL~     and cosmetic satisfaction. Patients with lymph node irradiation will be closely monitored for~     radiation induced plexopathy.~   "
34025|NCT03121235|"~     A standard treatment protocol for invasive aspergillosis (IA) will be implemented in several~     academic hematology centers in the Netherlands in which a diagnostic test demonstrating azole~     resistance by multiplex real-time polymerase chain reaction will guide the choice of~     appropriate antifungal treatment.~      Objectives:~        1. Improve the outcome of patients infected with azole resistant A. fumigatus by the early~          detection of Resistance Associated Mutations (RAMs) and with this the earlier initiation~          of the most appropriate therapy.~        2. Monitor the prevalence of invasive aspergillosis due to strains carrying the TR34/L98H~          or the TR46/T289A/Y121F resistance associated mutations in the Netherlands.~   "
34026|NCT03121222|"~     The main objective of the present study was to investigate whether N-acetylcysteine~     supplementation in individuals with low glutathione levels would confer ergogenic effects by~     replenishing glutathione levels and by reducing oxidative stress. Towards this aim,~     investigators sought to exploit the large inter-individual variability in redox biomarker~     levels. More specifically, investigators screened 100 male participants for glutathione~     baseline levels in blood and formed three stratified groups according to this value (i.e.,~     low, moderate and high; 12 individuals per group). After by-passing the regression to the~     mean artefact by performing a second glutathione measurement in the three aforementioned~     groups, investigators assessed both aerobic and anaerobic physical performance in order to~     acquire a more comprehensive view about the ergogenic effectiveness of the antioxidant~     treatment. This was accomplished by implementing three different whole-body physical~     performance tests (i.e., VO2max test, time trial and Wingate), as opposed to most in vivo~     studies that either applied isolated body-part exercise tests (e.g., by isokinetic~     dynamometry) or performed a single exercise test (e.g., time-to-fatigue test). It was~     hypothesised, that data of the present investigation will bridge the chasm between the~     scientific (i.e., chronic antioxidant supplementation blunts exercise performance and~     adaptations) and the community-based (i.e., free radicals should anyway be counteracted by~     protective exogenous antioxidants) truths about the role of antioxidants as ergogenic aids.~     It was also hypothesised that the results will show that low glutathione levels are linked to~     decreased aerobic and anaerobic physical performance accompanied by increased levels of~     oxidative stress and that N-acetylcysteine supplementation will restore both performance and~     redox homeostasis. Based on the findings of the present investigation, the widespread routine~     practice of consuming antioxidants during exercise training could be changed and the~     consumption of antioxidants would be restricted only for those who are deficient in~     glutathione.~   "
34027|NCT03121209|"~     We aim to determine whether cognitive impairment attributable to cerebral hemodynamic~     impairment in patients with high-grade asymptomatic carotid artery stenosis is reversible~     with restoration of flow. To accomplish this aim CREST-H will add on to the NINDS-sponsored~     CREST-2 trial (parallel, outcome-blinded Phase 3 clinical trials for patients with~     asymptomatic high-grade carotid artery stenosis which will compare carotid endarterectomy~     plus intensive medical management (IMM) versus IMM alone (n=1,240), and carotid artery~     stenting plus IMM versus IMM alone (n=1,240) to prevent stroke and death).~      CREST-H addresses the intriguing question of whether cognitive impairment can be reversed~     when it arises from abnormal cerebral hemodynamic perfusion in a hemodynamically impaired~     subset of the CREST-2 -randomized patients. We will enroll 500 patients from CREST-2, all of~     whom receive cognitive assessments at baseline and yearly thereafter. We anticipate~     identifying 100 patients with hemodynamic impairment as measured by an inter-hemispheral MRI~     perfusion time to peak (TTP) delay on the side of stenosis. Among those who are found to be~     hemodynamically impaired and have baseline cognitive impairment, the cognitive batteries at~     baseline and at 1 year will determine if those with flow failure who are randomized to a~     revascularization arm in CREST-2 will have better cognitive outcomes than those in the~     medical-only arm compared with this treatment difference for those who have no flow failure.~      We hypothesize that hemodynamically significant asymptomatic carotid disease may represent~     one of the few examples of treatable causes of cognitive impairment. If cognitive decline can~     be reversed in these patients, then we will have established a new indication for carotid~     revascularization independent of the risk of recurrent stroke.~   "
34028|NCT03121196|"~     Social deprivation during pregnancy is associated to adverse perinatal outcomes. However,~     prenatal screening of social deprivation by reliable measurement is not performed. Prevalence~     of social deprivation is yet underestimated during pregnancy and vulnerable women are not~     being provided optimal prenatal care.~      Our aim is to validate EPICES score during pregnancy.~   "
34029|NCT03121183|"~     The growing use and the expanding indications for cardiovascular implantable electronic~     devices (CIEDs) have been associated to an increase of device removal. The indications of~     CIEDs removal are infectious (55%) or noninfectious (45%) such as upgrading of devices,~     nonfunctional devices and thrombosis. Removal can be performed according to transvenous or~     surgical procedures. Transvenous lead removal (TLR) must be done by experimented~     cardiologists and respecting current consensus. TLR can be done with conventional techniques~     involving inserting locking stylets and telescoping sheaths around the pacing leads to~     separate them from the surrounding scar tissue. These conventional procedures have a success~     rate of ≈65%. TLR thanks to laser sheath has been validated and improved the success rate~     until >95%. However, the TLR from chronically implanted CIEDs still carries a significant~     risk of procedural failure, morbidity, and mortality, related to tearing of the great vessels~     and cardiac structures, even when performed by experienced operators. Even if the transvenous~     extraction using laser sheath seems to be more effective, this strategy would be more~     expensive.~      Considering the availability of several strategies for TLR and the cost heterogeneity of~     procedures, a cost assessment in real life of these therapeutic strategies is essential for~     an optimal choice of therapeutic strategies.~   "
34030|NCT03121170|"~     Primary dysmenorrhea (PD) is a common female disease during menstruating. Although~     nonsteroidal anti-inflammatory drug is an effective treatment, there are concerns about side~     effects. Alternative therapies, including acupuncture and moxibustion, are commonly used for~     PD. Nevertheless, traditional Chinese medicine takes longer period than Western medicine to~     release PD. Extracorporeal shock wave therapy (ESWT) originally for the treatment of~     musculoskeletal diseases has characteristics of fast curative effect and no wound. Currently~     there is no report about clinical use of ESWT for the treatment of PD. Our study is to~     determine whether ESWT is effective in the treatment of PD based on meridian theory of~     traditional Chinese medicine. The investigators hypothesis that ESWT during PD is more~     effective than ESWT before PD or abdominal hot paste during PD without ESWT.~   "
34031|NCT03121157|"~     The purpose of the Detroit Young Adult Asthma Project is to test a technology based program~     to help African American young adults learn to better manage their asthma. Participants will~     be randomized to a multi-component technology-based intervention (MCTI) targeting asthma~     medication adherence or to a comparison control condition.~   "
34032|NCT03121131|"~     The use of computed tomography (CT) imaging is rapidly increasing in healthcare. Despite~     physicians' growing reliance on radiological assessments, however, the reliability and~     accuracy of reads are highly variable. Inconsistencies may result from multiple factors.~      The researchers hypothesize that the presence and quality of clinical information will affect~     radiologist's assessment of CT scans for the presence/absence of a ventral hernia.~   "
34033|NCT03121118|"~     Diagnostic tests designed to detect Alzheimer's disease (AD) pathology are increasingly~     popular in research on cognitive aging and AD. Due to concerns that information from such~     tests may be misunderstood, psychologically harmful, and of unclear clinical significance,~     results of pre mortem tests of AD pathology have typically been withheld from research~     participants. However, as the reliability and potential clinical significance of tests like~     brain amyloid imaging have become clear, there is a pressing need to revisit the practice of~     unilaterally withholding such information from research participants and identify responsible~     approaches to communicating individual results. Amyloid imaging results may be particularly~     relevant to mild cognitive impairment (MCI), a population for whom a growing body of evidence~     suggests that such testing may provide valuable prognostic and planning information, despite~     the unavailability of interventions to alter one's clinical course. Our preliminary work~     suggests that research participants with MCI and their family members are receptive to and~     capable of understanding information about the purpose, results, and implications of amyloid~     imaging when presented using a standardized approach developed by our interdisciplinary team.~     Building on this work, the proposed study will examine a well characterized sample of MCI~     care dyads (patient + family member) who will be randomized to either receive the opportunity~     to decide if they would like to pursue an amyloid PET Scan, or be randomized to not receive~     that opportunity (and will serve in the no-scan comparison group). This study aims to test~     hypotheses that examine how receiving amyloid imaging results will impact understanding of,~     and perceived self-efficacy for coping with, MCI among both patients and care partners.~   "
34034|NCT03121105|"~     Our objective is to describe the pathologic and MRI findings in a series of patients with~     presumed demyelinating lesion of the central nervous system.~   "
34035|NCT03121092|"~     Angiotensin converting enzyme inhibitors (ACEI's) and Angiotensin receptor blockers (ARB's)~     are commonly used anti-hypertensive medications that may have implications on the management~     of a patient undergoing surgery. Limited research has looked at the effects of these~     medications on perioperative complications and mortality. Some studies conducted on small~     groups of inpatients with advanced vascular disease undergoing vascular surgery or coronary~     artery bypass grafting (CABG), suggest exacerbation of hypotension (low blood pressure) in~     patients who continued taking ACEI's or ARB's on the morning of their procedure. In addition,~     cases of low blood pressure (BP) that were refractory to standard treatment were reported.~     One recent retrospective study reported no difference in severe hypotension and only a modest~     difference in moderate hypotension managed by conventional treatment, but did not adequately~     address the risk of preoperative hypertension. A study recently published by the~     investigators (Twersky et al., 2014) in over 600 patients demonstrated no difference in~     preoperative hypertension in ambulatory surgery and same day admission patients. There has~     been limited data stratifying the degree of low BP based on severity but these were not done~     in ambulatory patients, and neither was the degree of high BP from discontinuing these~     medications addressed. As such, no uniform consensus has been reached and clinicians are~     unclear as to whether the reported inpatient findings are applicable to the outpatients,~     since they differ in many respects. The investigators propose to evaluate whether ACEI's and~     ARB's discontinued preoperatively have a negative impact on perioperative hemodynamics and~     patient outcome in a group of ambulatory and same day surgical patients. Similar to studies~     done on inpatients, the investigators will also evaluate patients receiving a standardized~     general anesthetic for hemodynamics following induction of anesthesia until surgical~     incision.~      The investigators hypothesize that continuing ACEI's and ARB's in the preoperative period~     does not result in an increased risk of severe hypotension (low blood pressure) following~     induction of general anesthesia.~   "
34036|NCT03121079|"~     Allogeneic stem cell transplantation (SCT) remains a powerful therapeutic modality for~     patients with acute myeloid leukemia (AML).The superior clinical outcomes of allogeneic human~     SCT versus chemotherapy alone as post-remission treatment could be related to the~     graft-versus-leukemia (GVL) effects of recovered donor T cells. Our previous study~     investigated both the association of MRD status with transplant outcomes in haplo-SCT and~     matched sibling donor transplantation(MSDT)， and also possible differences in the transplant~     outcomes of patients with positive pre-MRD (as determined by MFC) who underwent haplo-SCT~     versus MSDT. It provided new evidence that unmanipulated haplo-SCT is superior to matched~     sibling donor transplantation in eradicating pre-transplantation MRD, indicating that~     unmanipulated haploidentical allografts have stronger GVL effects.As to the AML patients in~     standard-risk, who have a positive MRD before MSDT, whether these patients should be given~     any relapse prevention is the question to be answered in this study. Interferon α-2b exerts a~     relatively strong immunomodulatory effect. It can kill AL cells by regulating T-cell and/or~     natural killer cell functions.Consequently, interferon α-2b may have potential value for~     high-risk AL patients after transplantation. The study hypothesis: Using interferon α-2b~     following hematopoietic stem cell transplantation in patients with standard-risk AML can~     further reduce relapse rate and improve leukemia-free survival.~   "
34037|NCT03121066|"~     Background: Alzheimer's disease is a major health problem in our society. To date,~     pharmacological treatments to reduce Alzheimer's disease symptoms have obtained poor results~     and there is a growing interest in finding non-pharmacological treatments for this impactful~     disease. Transcranial Magnetic Stimulation is a non-invasive tool which can induce changes in~     brain activity and long term modifications of impaired neural networks, and therefore holds~     promise as a clinical intervention.~      Our overall goal is to study the benefit of targeting Transcranial Magnetic Stimulation based~     on the individual's unique functional connectivity (personalized targeting) instead of~     current non-individualized approaches. Specifically, the intermittent Theta Burst protocol~     will be used and changes in cognitive, functional, and emotional deficits in these patients~     will be evaluated. Functional brain connectivity changes induced by the TMS treatment will be~     also assessed.~      Methods: A double blind randomized controlled trial will be conducted to assess the effects~     of TMS treatment immediately, one month, three months and six months after the end of the~     treatment in comparison to the baseline measurements. Forty-five patients with a diagnosis of~     Alzheimer's disease, will be randomly allocated (1:1:1) into experimental (active~     Transcranial Magnetic Stimulation), sham control group, or conventional intervention control~     group. Neuropsychological, functional, and emotional assessment will be conducted, as well as~     functional connectivity measures, in order to assess the effectiveness of the treatment.~      Discussion: The investigators expect to demonstrate that personalized Transcranial Magnetic~     Stimulation intervention has measurable positive impact in cognitive and emotional~     functioning, functionality, and brain connectivity, thus representing a potential treatment~     for Alzheimer's disease.~   "
34326|NCT03117257|"~     This study is to observe and compare the safety and tolerability of docetaxel plus lobaplatin~     induction chemotherapy combined with lopoplatin chemoradiotherapy and TPF induction~     chemotherapy combined with cisplatin chemoradiotherapy in the treatment of locally advanced~     head and neck squamous cell carcinoma.~   "
34038|NCT03121053|"~     Chronic kidney disease (CKD) and (subsequent) acute kidney injury are frequent in patients~     undergoing transcatheter aortic valve implantation (TAVI). Moreover, these patients are~     easily hypervolemic and susceptible for cardiac decompensation. Prevention of contrast~     induced nephropathy (CIN) has not yet been studied in these patients, and evidence on~     different strategies is urgently needed. The objective of this study is to evaluate the~     efficacy of 250ml 1.4% sodium bicarbonate versus hypotone saline (0.65% sodiumchloride)~     hydration prior to TAVI in patients with CKD to prevent CIN.~   "
34039|NCT03121040|"~     ATP is generated mainly through anaerobic metabolism during strenuous exercise, which is then~     followed by the generation of lactic acid. However, this process can only be maintained for a~     short time, approximately one minute, because the accumulation of lactic acid in the muscles~     may affect muscle performance. The efficiency of lactic acid metabolism is one of the most~     important reasons for endurance improvement. The purpose of this study was to evaluate the~     impacts of the daily ingestion of a commercially available Vespa amino acid mixture (VAAM®)~     beverage on blood parameters that are related to fatigue, muscle damage and immunity in~     healthy, young athletes during middle-distance running exercises. VAAM® contains 17 types of~     amino acids at a certain ratio, and evaluations were completed during 10 weeks of consecutive~     required speed and strength running tests.~   "
34040|NCT03121027|"~     Despite significant advances in the field of medicine and healthcare, anemia continues to be~     a major public health problem worldwide. The situation is particularly acute in developing~     countries where females belonging to the reproductive age category are especially vulnerable~     to the malady. Given the multifactorial nature of this disease, correcting anemia often~     requires the adoption of an integrated approach. Therefore, it is imperative that the role~     played by the causes of the causes (i.e., the sociodemographic determinants of risk), along~     with other contributing factors, must be identified, and addressed in order to effectively~     combat this disease. In general, it is terrible to sort out the psychosocial factors from the~     demographics, environmental and poverty-related causes. Therefore, the objective of this~     study is to use a nationwide representative survey to explore the magnitude of household~     economic inequalities contribute towards the prevalence of anemia among ever-married women in~     Bangladesh. The study also aims to examine the inference of other explanatory variables that~     frequently had supposed decomposing on the burden of anemia. Thus, this study answers the~     questions: (a) what are the strengths and likelihoods of having mild, moderate or severe~     anemia among the ever married women of different SES?; (b) do other factors viz.,~     demographics, diabetes, maternity, and BMI affects the strength and form of the association~     between SES and anemia?; (c) which explanatory variable is more prone to pose anemia among~     the women? As the burden of anemia is one of the key policy issues facing Bangladesh, the~     findings generated by this study are expected to contribute towards further policy making by~     virtue of identifying associated risk factors. This is expected to be instrumental for~     program purposes designed to prevent anemia among Bangladeshi women.~   "
34041|NCT03121014|"~     The study is a Phase II clinical trial. Patients will receive intensity modulated total~     marrow irradiation (TMI) at a dose of 9 Gy with standard myeloablative fludarabine/ i.v.~     targeted busulfan (FluBu) conditioning prior to allogeneic hematopoietic stem cell transplant~     (HSCT).~   "
34042|NCT03121001|"~     The study is a Phase II clinical trial. Patients will receive intensity modulated total body~     irradiation (TBI) at a dose of 3 Gy with standard fludarabine/ i.v. cyclophosphamide~     conditioning prior to human leukocyte antigen (HLA)-haploidentical hematopoietic stem cell~     transplant (HSCT).~      The primary objective of the study is to determine the engraftment at Day +60 following~     HLA-haploidentical hematopoietic stem cell transplant protocol using immunosuppressive agents~     and low-dose total body irradiation (TBI) for conditioning and post-transplant~     cyclophosphamide in patients with sickle cell disease.~   "
34043|NCT03120988|"~     The purpose of this study is to understand how the components of osteoarthritic knee joint~     fluid (synovial fluid) change after lavage treatment with platelet poor plasma. Additionally,~     the study participants will complete outcome questionnaire surveys before and after the~     treatment in conjunction with when synovial fluid is removed from the knee (2, 4, and 6 weeks~     after lavage). This data will help determine if the treatment of an osteoarthritic knee joint~     with platelet poor plasma lavage is a suitable stand-alone therapy or to improve outcome by~     preparing a patient's knee for further regenerative therapies.~   "
34044|NCT03120975|"~     Prescribing antibiotics frequently poses problems in practice, since patients don't always~     receive the right dosage of the right antibiotic for the right period of time. This promotes~     the emergence and spread of antibiotic resistance. The investigators of this trial aim to~     develop a system designed to help doctors to use antibiotics more appropriately. Under~     COMPASS (COMPuterized Antibiotic Stewardship Study), doctors in three Swiss hospitals will~     receive tips on the use of antibiotics that are integrated directly into electronic health~     record and will also be given regular feedback on their use of antibiotics. Parallel to this,~     data on the antimicrobial prescription practices of a control group which is not using the~     system will be collected.~   "
34045|NCT03120962|"~     Postherpetic neuralgia (PHN) which persists more than 90 days after the resolution of the~     acute shingles episode is the most common complication of herpes zoster. The continued pain~     or paresthesia not only affects patient quality of life, but also causes physical disability,~     emotional distress and social isolation. Conventional treatments for PHN are only partially~     work in some patients or not work at all in others. Once PHN presences, it is often~     refractory to the treatment, therefore, it is important to prevent the occurrence of PHN. In~     the study, the investigators want to identift whether the additional use of oxycodone therapy~     to current standard treatment in acute herpes zoster patients will decrease the incidence of~     post-herpetic neuralgia.~   "
34046|NCT03120949|"~     The purpose of the study is to evaluate how safe, how effective and how well tolerated, the~     study drug Olokizumab is, in the long-term, in patients with Rheumatoid Arthritis (RA) who~     have previously taken part in and completed 24 weeks of blinded treatment in one of the core~     studies - CREDO 1, 2 or 3.~   "
34047|NCT03120936|"~     The Stay Study is a multi-site, open-label HIV pre-exposure prophylaxis (PrEP) demonstration~     project for advancing PrEP delivery in the San Francisco Bay Area Transgender Community.~     Approximately 188 HIV-uninfected participants will be enrolled at 4 sites in San Francisco~     and Fremont and will be provided Truvada to take orally once daily as PrEP.~   "
34048|NCT03120923|"~     This study aims to assess and compare the effectiveness of two different volumes of local~     anesthetic combined with 40mg of triamcinolone for subacromial injections in treating~     patients with rotator cuff impingement syndrome~   "
34408|NCT03116178|"~     Intraoperative fluid given according to BMI in group B and according to pulse oximeter-~     derived pleth variability index(MASIMO RAINBOW PULSE CO OXIMETRY) in group G. Comparison of~     haemodynamics, urine output,blood lactate levels, blood sugar, flap sugar and coagulation~     profile between the two groups.~   "
34049|NCT03120884|"~     This will be a prospective, randomized (1:1 ratio) clinical trial for non-male factor~     infertility in advanced maternal age with or without intracytoplasmic sperm injection(ICSI).~     Qualified 1422 patients are randomized into either of two groups: group A will undergo~     conventional in-vitro fertilization(IVF)(711 cases), Group B will undergo intracytoplasmic~     sperm injection (ICSI) (711 cases). All participants will receive the same protocol for~     ovarian stimulation and standardized luteal phase support.~      The target population will be patients with non-male factor infertility aged ≥38years with~     FSH ≤15. Women with other reasons of infertility (eg. anovulation, endometriosis, and~     premature ovarian failure) are excluded.~      The randomization will take place before controlled ovarian stimulation by a computer~     randomization system. The accumulated live birth rate , pregnancy complications will be~     followed up by checking medical records and telephone calls.~   "
34050|NCT03120871|"~     The Microbiome Insulin Sensitivity Study MISS is a pilot study designed to study microbiome~     composition across puberty and how it relates to insulin sensitivity and secretion in obese~     girls, who are at increased risk for developing type 2 diabetes in puberty. The investigators~     will evaluate the gut microbiome composition in fecal samples of 57 obese girls in three~     groups: prepubertal (Tanner 1), early pubertal (Tanner 2-3), and late pubertal (Tanner 4-5).~     Insulin sensitivity will also be measured via an intravenous glucose tolerance test (IVGTT)~     in 18 prepubertal and late pubertal participants.~   "
34051|NCT03120858|"~     Imagery is determined with two strategies to mentally simulate the movements: visual and~     kinesthetic imagery. Visual motor imagery (VMI) is associated with spatial coordinates of a~     movement in the environment and through this speciality VMI applies mainly to the imagery of~     moving objects or to movement of another person in the imagined environment, although imagine~     of own movement is also possible. Kinesthetic motor imagery depends on dynamic relationship~     among the individual, the movement and the environment and it should be determined by the~     nature of the task, the environment and individual characteristics and also requires feel~     the movement.~      The aim of this study is to translate this questionnaire into Turkish and the translation in~     terms of its internal consistency, test-retest reliability.~   "
34052|NCT03120845|"~     Aim :to compare incidence of post-operative pain and apical healing after single-visit versus~     two-visit root canal treatment of teeth with necrotic pulp and apical periodontitis.~   "
34053|NCT03120832|"~     This is a Phase I, open-label, parallel design study of PAN-301-1 (SNS-301-1), a HAAH~     directed nanoparticle vaccine, given intradermally in cohorts of patients with biochemically~     relapsed prostate cancer, using a fixed dose escalation schema every 21 days.~   "
34054|NCT03120819|"~     Fatigue is a troublesome symptom for breast cancer patients, which might be mitigated with~     exercise. Cancer patients often prefer their oncologist recommend an exercise program, yet a~     recommendation alone may not be enough to change behavior. Our study will determine whether~     adding an exercise DVD to an oncologist's recommendation to exercise led to better outcomes~     than a recommendation alone.~   "
34055|NCT03120806|"~     Non-diabetic pregnant women who undergo elective CS will be randomized into two groups: group~     I included women who has their skin closed with subcuticular interrupted mattress suture~     using non-absorbable polypropylene, and group II included women who has their skin closed~     with subcuticular continous suture using the same suture material~   "
34056|NCT03120793|"~     The use of esophageal balloon catheters, which use esophageal pressure as a surrogate~     measurement for transpleural pressure, shows promise in improving outcomes of patients with~     severe acute respiratory distress syndrome (ARDS) requiring mechanical ventilator. The~     investigators hope to measure changes in in transpleural pressures in patients undergoing~     treatment with mechanical ventilation while switching from the supine, upright (head of bed~     >30 degrees), and prone positions. The goal will be to measure the changes in chest wall and~     lung compliance in mechanically ventilated patients with changes in position.~   "
34057|NCT03120780|"~     This study is being done to investigate if there is more effective pain relief during the~     latter stages of labor and delivery when epidural fentanyl 100mcg is administered compared to~     epidural fentanyl 20mcg.~   "
34058|NCT03120767|"~     The goal of this study is to evaluate the effect on first-year college students of~     participation in a 14-week seminar course and residential housing wellness activities.~   "
34059|NCT03120754|"~     Common bile duct stones in clinical manifestations of biliary colic, obstructive jaundice,~     cholangitis, pancreatitis and other symptoms. At present, thanks to the rapid development of~     minimally invasive surgery and the concept of ERAS, laparoscopic common bile duct incision~     and primary suture has been gradually used as a routine surgical approach in clinical~     application. However, whether or not to place the abdominal drainage tube after surgery, so~     far has not yet reached a consensus. Therefore, this study focuses on the clinical advantages~     of LCBDE+PC placed abdominal drainage.~   "
34060|NCT03120741|"~     This study is an observational study that uses daily activity and environmental sensing~     techniques to establish behavioral models of early dementia patients and cognitive healthy~     function to assess their daily behavior and determine their activities. Specifically, the~     team will collect information on a number of wireless sensors for dementia, mild cognitive~     impairment and healthy elderly residents, and use special mathematical models to establish~     the behavior of the two groups of subjects Model. The model will be developed a reliable~     algorithm to assess health risk of the subjects.~   "
34061|NCT03120728|"~     This study is enrolling healthy women ages 18-39yo who are not pregnant or breastfeeding, and~     are not using hormonal birth control. Initial screening visit will include a blood draw to~     assess if the participant has recently ovulated. If hormone test indicates ovulation~     occurred, participant will start the study 8 days after the start of their next menstrual~     period. On this study visit, vaginal ultrasound will be performed to look the ovaries for~     follicles. Vaginal ultrasound is then performed approximately every 2 days until the dominant~     follicle has grown into the size group assigned. When this occurs the participant will place~     the NuvaRing®, inside the vagina and blood will be drawn for hormone levels. Participant will~     then return daily the next 5 days (total of 6 daily visits) for vaginal ultrasound and blood~     draw to assess for signs of ovulation. After the 7th day the ring is in the vagina, the~     participant will remove the ring from her vagina at home. After removal, there will be twice~     weekly clinic visits for ultrasound and blood draw until menstrual bleeding occurs. At this~     point, participation in the study is complete. Participants are compensated for their time.~   "
34062|NCT03120715|"~     Embryo freezing is a technique used commonly to optimize the pregnancy rate in assisted~     reproduction techniques (ART). Hormone replacement therapy (HRT) regimen is applied to~     prepare endometrium for frozen embryo transfer (FET) commonly.At present, It is unclear~     whether preimplantation low molecular weight heparin (LMWH) improves live birth and pregnancy~     rates in subfertile women undergoing FET. The study is a prospective randomized controlled~     trial to compare the pregnancy outcomes of FET in hormonal replacement therapy(HRT) cycles~     with or without LMWH administration before implantation.~   "
34063|NCT03120689|"~     This is research in which students are queried by questionnaires on their satisfaction with~     and experience with certain educational practices (use of a camera image projecting during a~     live surgery) or with pre-recorded video. As data collection only involves survey data~     collection and satisfaction with an educational experience, and randomization/intervention is~     only involving use of one type of educational method versus another .~   "
34064|NCT03120676|"~     This is a study with the purpose of studying the safety and efficacy of the study drug~     Atezolizumab in patients with relapsed or refractory Hodgkin lymphoma (HL). Atezolizumab~     could shrink cancer but it could also cause side effects. This study will also test any good~     and bad effects the study drug. Other aims include studying biomarkers that will help~     researchers understand how the drug works.~   "
34065|NCT03120663|"~     In this prospective observational study, the investigators want to document~     pharmacokinetic/pharmacodynamic (PK/PD) target attainment of frequently used antimicrobials~     in an adult non critically ill surgery population (abdominal surgery, traumatology and septic~     orthopedic surgery). Furthermore, the investigators want to identify risk factors for not~     attaining predefined PK/PD targets.~      The antibiotics of interest are amoxicillin(-clavulanic acid), flucloxacillin,~     piperacillin-tazobactam, meropenem and clindamycin.~   "
34066|NCT03120650|"~     Scalp acupuncture formed by combining traditional Chinese acupuncture techniques and modern~     theories in medical anatomy has been widely used to treat ischemic stroke in China, but~     effective clinical trials that verify its efficacy are lacking. This study proposes to verify~     the effects of Lu's scalp acupuncture on ischemic stroke by comparing differential~     improvement of motor function between conventional rehabilitation alone and conventional~     rehabilitation with Lu's scalp acupuncture.~   "
34067|NCT03120637|"~     Mortality rates associated septic shock remains unacceptably high, around 20-50%, with~     refractory hypotension in half of these patients. Widespread vasodilatation involves the~     activation of the soluble intracellular enzyme guanylate cyclase (GC) by nitric oxide (NO),~     resulting in the production of cyclic guanosine monophosphate (cGMP). Initially discovered as~     an endothelium-derived relaxing factor in blood vessels, NO is made by the enzyme nitric~     oxide synthase (NOS). It has been suggested that the inhibition of NO generation might be a~     treatment option for sepsis and septic shock. Methylene blue (MB) is a dye that easily~     crosses cell membranes, inhibits iNOS, and is capable of inhibiting the GC enzyme in vascular~     smooth muscle cells.Early use of MB can block the progressive decrease in systemic vascular~     resistance of patients unresponsive to noradrenaline and mitigate the need for prolonged~     vasoconstrictor use. The investigators propose to study the effect of methylene blue on~     cirrhotic adults with sepsis, with refractory vasoplegia unresponsive to maximum doses of~     noradrenaline and vasopressin.~   "
34068|NCT03120624|"~     This phase I trial studies the side effects and best dose of vesicular stomatitis virus-human~     interferon beta-sodium iodide symporter (VSV-hIFNbeta-NIS) in treating patients with stage IV~     endometrial cancer or endometrial cancer that has come back. The study virus,~     VSV-hIFNbeta-NIS, has been changed so that it has restricted ability to spread to tumor cells~     and not to healthy cells. It also contains a gene for a protein, NIS, which helps the body~     concentrate iodine making it possible to track where the virus goes. VSV-hIFNbeta-NIS may be~     able to kill tumor cells without damaging normal cells.~   "
34069|NCT03120611|"~     All participants exercised during 16 weeks following a conventional intradialysis exercise~     program. The last 4 weeks of the study participants were randomized into two different~     exercise programs intradialysis. One group exercised through a virtual reality exercise~     adapted specially for patients while receiving hemodialysis treatment. The other group~     exercised with a conventional exercise program, combining aerobic cycling and strengthening~     exercises.~   "
34070|NCT03120598|"~     A cluster randomized experiment focused on testing the extent to which the~     organization-focused Implementation & Sustainment Facilitation (ISF) strategy is an effective~     adjunct to the staff-focused Addiction Technology Transfer Center (ATTC) strategy.~   "
34071|NCT03120585|"~     The object of this study is to determine the best way to care for infants with respiratory~     distress. The investigators are testing a method of feeding fluids to infants with~     respiratory distress in amounts similar to what healthy breastfed babies eat when they are~     feeding on demand, and comparing this method to the current standard of care for feeding~     fluids to infants with respiratory distress. These methods of feeding fluids to the study~     infants will continue until the infants are able to feed normally by mouth. The study will~     include about 400 infants across five sites in the United States, Chile and Argentina.~   "
34072|NCT03120572|"~     The purpose of this study is to investigate the effect of concurrent chemoradiation therapy~     on respiratory muscle performance, lung function and functional capacity in patients with~     local esophagus cancer.~   "
34073|NCT03120559|"~     This study proposes to evaluate the effects of using a new floss holder (GumChuck) and the~     use of text messages during supportive periodontal therapy, on the psychological, behavioral~     and clinical parameters of patients with gingivitis, outlined by evidence and a theory-based~     framework.~   "
34074|NCT03120546|"~     In this study, investigators are going to compare cervical spine motion during tracheal~     intubation using video laryngoscope or rigid video stylet in patients with simulated cervical~     immobilization.~   "
34075|NCT03120533|"~     The study is conducted to confirm the good tolerance of a continuous cathodal iontophoresis~     of the treprostinil hydrogel administered during 10 days on the pulp of the finger of healthy~     volunteer and on the ischemic digital ulcerations of Systemic Sclerosis patients,~     particularly to estimate the cutaneous tolerance of the procedure and the effect on the blood~     pressure.~   "
34076|NCT03120520|"~     This is a study of efficacy and safety of Plecanatide in pediatric subjects aged 12 to < 18~     years diagnosed with Chronic Idiopathic Constipation.~   "
34077|NCT03120507|"~     The Resuscitation Outcomes in the Netherlands - study assesses one-year survival and quality~     of life after In-Hospital Cardiac Arrest(IHCA). It's design is a multicenter prospective~     observational cohort study which will include all patients undergoing cardiopulmonary~     resuscitation (CPR) for IHCA in 2017. Current literature describes poor survival after IHCA~     and no risk stratification tool for long-term outcome is available. Furthermore no such study~     has ever been performed in the Netherlands. The investigators aim to gain further insight in~     this major adverse event.~   "
34078|NCT03120494|"~     75 subjects at risk for HIV infection (25 high risk MSM and 50 sero-discordant couples) will~     be recruited. All subjects will receive Truvada for pre-exposure prophylaxis or PrEP, as well~     as routine medical evaluations during one year. Subjects will be managed according to CDC's~     guidelines on the management of PrEP as a tool for HIV prevention.~   "
34079|NCT03120481|"~     This is the registry of control participants for patients with various respiratory diseases.~     We screened healthy volunteers who visited Seoul National Hospital Healthcare System Gangnam~     Center for routine health check-up, and enrolled patients who agree to participate in the~     study. The participants undergo baseline questionnaires, provide blood specimen and~     information of the results of health check-up. We will include participants as controls if~     they have no significant respiratory symptom and no significant radiographic abnormality. The~     data from this registry will be compared with those from other registry of various~     respiratory diseases~   "
34080|NCT03120468|"~     This is a pilot study designed to evaluate the safety, tolerability of Topiramate (TPM) +~     N-Acetyl Cysteine (NAC) in combination versus Topiramate (TPM) + placebo for the treatment of~     alcohol use disorder (AUD).~   "
34081|NCT03120455|"~     The purpose of the current study is comparing the effect of almond and pistachio, as the two~     common types of nuts, consumption on healthy obese and overweight female who following a~     hypocaloric diet for 12 weeks. The secondary aim of the current study is to evaluate of these~     two type of nuts on other cardiometabolic risk factors.~   "
34082|NCT03120442|"~     Postoperative delirium after total knee replacement surgery has been related to significant~     morbidity and mortality among high risk patients. Anesthetic care might play a role in the~     development of postoperative delirium.~      The purpose of this study is to compare the incidence of postoperative delirium between~     different intraoperative sedation regimen. Delirium assessment using standardized screening~     tools will be done every 8 hours after surgery.~   "
34083|NCT03120429|"~     the aim of present study is to compare the specific effects moderate consumption of lean fish~     on weight loss of healthy obese and overweight female adults, while participants follow~     energy-restricted diets also to investigate the effects of this intervention on carbohydrate~     and lipid profiles, as cardiometabolic risk factors.~   "
34084|NCT03120416|"~     The investigators aim to evaluate the feasibility of a resistance exercise training program~     among individuals with CKD and its impact on endothelial and vascular function.~   "
34085|NCT03120403|"~     Postoperative pain in pediatrics can usually be well controlled with a combination of~     analgesics including acetaminophen ( paracetamol) ,NSIADS, opioids , and local/regional~     anesthesia.The use of epidural and subarachnoid morphine for analgesia in adults has grown~     almost as quickly as Morton`s discovery of anesthesia in 1846. The application of these~     techniques to the pediatric patients has evolved much more slowly,although significant~     progress is being made by many investigators.~   "
34086|NCT03120390|"~     This randomized phase II trial studies how well physical activity works in reducing metabolic~     dysregulation in obese Latina breast cancer survivors. Physical activity may improve fitness~     and lessen metabolic disease (such as coronary artery disease, stroke, and type 2 diabetes)~     risk factors in patients who have breast cancer.~   "
34087|NCT03120377|"~     Evaluate the effectiveness of a Whole body vibration training program on quadriceps muscle~     strength, functional capacity and respiratory muscle strength in adult renal transplant~     recipients~   "
34088|NCT03120364|"~     This study assesses non-inferiority by comparing GMR(Geometric Mean Ratio) of NBP608 to~     Zostavax which are evaluated by gpELISA (Glycoprotein Enzyme Linked Immunosorbent Assay).~     Total of 824 healthy subjects (412 subjects per treatment arm) aged 50 and over are enrolled,~     and each subject is administered with single dose of vaccine which is randomly assigned.~   "
34089|NCT03120351|"~     The post-thoracotomy pain (PTP) has been defined as persistent or recurrent pain that lasts~     for at least 2 month after thoracotomy and is associated with surgical incision or its~     intercostal nerve cutaneous distribution. The latter has a prevalence of about 15% to 20%. In~     about 80% of the patients such pain is moderate to severe in intensity and is associated with~     depression and insomnia. According to its characteristics and possible etiology, PTP is part~     of the neuropathic pain syndromes. Patients describe their chest wall pain as shooting,~     burning and numbness which are descriptors often seen in other neuropathic pain syndromes.~     PTP occurs most likely after partial or complete intercostal nerve damage secondary~     mechanical trauma (nerve traction or compression) during surgery. The concern is that when~     robotic surgery for minimally invasive approach to the heart valves or vessels such~     compression and consequent damage may happen to intercostal nerves.~      Therapeutic use for a lidocaine patch include post-herpetic neuralgia postthoracotomy pain,~     stump neuroma pain, intercostal neuralgia, diabetic polyneuropathy, meralgia paresthetica,~     complex regional pain syndrome, radiculopathy, postmastectomy pain and some other focal~     peripheral neuropathic pain syndromes. It is an effective and safe topical treatment. Its~     efficacy demonstrated previously in treatment of intercostal neuralgia and some patients with~     post-thoracotomy syndrome can be used in treatment of perioperative chest pain related to~     robotic cardiac surgery. Hypothesis is that the use of topical lidocaine will decrease pain~     in acute phase after the surgery and decrease intensity of post-thoracotomy pain 6 months~     after such procedure.~      The effect of topical 5% lidocaine will be clinically evaluated through prospective,~     randomized, placebo, double-blind study. Each patient will be assessed at admission and then,~     one week after Valve Replacement (Recommended surgical procedures do not included harvesting~     of leg vessels as this could be a potential confounder). Then, one month, three and six month~     follow-up for all patients by mailing questionnaires and phone calls.~      Upon admission, as well as 1 week, 1month, 3months and 6 months following surgical procedure,~     the following tests will be performed:~        -  Pain Disability Index (PDI)~        -  DASS~        -  VAS Pain Score~        -  Opioid use (in MSO4 mg equivalents)~        -  Global Perceived Effect (GPE) or patient satisfaction~   "
34104|NCT03120156|"~     People with weak balance ability or subjective feeling of dizziness and unsure gait are~     separated into 3 training-groups. One Group is getting no insoles, the second group is~     getting modern sensomotoric insoles, and the third group is getting normal standard insoles.~     All are passing a 6 week proprioceptive training.~      Main outcome measurements are posturography at baseline, 3 weeks and 6 weeks. Secondary~     measurements are ABC-Scale, Tinetti Gait and balance test and functional reach test at~     baseline and after 6 weeks.~   "
34409|NCT03116165|"~     This study will examine the use of modified prolonged exposure therapy in trauma patients~     recently exposed to trauma in an emergency room to prevent the onset of post-traumatic stress~     disorder.~   "
34090|NCT03120338|"~     The European Union is funding this randomised trial in Finland and Scotland as part of the~     larger eCAP project (http://www.interreg-npa.eu/projects/funded-projects/project/139/). The~     need for psychiatric services for children and adolescents is usually greater than the~     services available. As well as this, in many cases, there is confusion as to which service~     the child or young person should be referred to. The way children and young people arrive at~     Child and Adolescent Mental Health Services (CAMHS) may therefore be relatively inefficient~     and families could suffer as a result of this inefficiency.~      The use of a computerised structured questionnaire such as the Development and Well-being~     Assessment (DAWBA) offers the opportunity for these difficulties to be addressed, for the~     avoidance of 'inappropriate referrals' and for more rational use of resources. It is usually~     administered online through a secure internet portal. At the end of the data collection, a~     computerised summary is generated from the data given by all the informants and a~     child/adolescent psychiatrist lists the likely diagnosis or diagnoses in a summary of the~     case and gives his view about the next steps. This is then made available to the referrer.~     This community-based study aims to establish whether using the DAWBA in this way helps~     children and young people with mental health problems. The main objectives are to improve~     their mental health, reduce waiting times, change referral practice, increase satisfaction in~     services and improve cost effectiveness. The principal outcome measure will be parent-rated~     Strengths and Difficulties Questionnaire (SDQ) score 6 months after randomisation. Secondary~     outcome measures will include teacher and child-rated SDQ at 6 months and waiting times to~     services. The investigators will also record service use data and family out -of -pocket~     costs. A random sample of young people, family and referrers will be interviewed to explore~     satisfaction with service.~   "
34091|NCT03120325|"~     This study is investigating a new form of treatment for a digestive disorder called~     gastroparesis. Gastroparesis is thought to be caused by a mix of inflammation and neural~     dysfunction. The vagal nerve is a large nerve originating from the brain that regulates~     digestive function. Patients with gastroparesis have what is a called a low vagal tone which~     results in gastrointestinal motility problems and inflammation; therefore, investigators~     hypothesize that increasing vagal tone through a hand-held vagal nerve simulator will reduce~     inflammation and gastrointestinal motility problems in gastroparesis patients. Investigators~     will evaluate this hypothesis through the use of upper endoscopy testing, breath testing, and~     blood, stool, urine, heart rate variability, and saliva testing before and after 4 weeks of~     vagal nerve stimulation (VNS) treatment.~      There are 6 research visits~      Visit 1 and visit 2 may take up to 8 weeks (screening/baseline) Visit 3 and visit 4 will take~     4 weeks (VNS treatment) visit 5 and 6 will take approximately 4 weeks (VNS followup/washout)~      Consequently, it is possible that if a patient were to be at the farthest ends of visit~     windows, they could potentially be in the study for approx 16 weeks. Visit 1 and 2 may be~     less than 8 weeks which would shorten the patient's overall involvement in the study.~      The treatment phase of the study will always be 4 weeks with an additional 4 week washout~     phase.~      Use of the VNS device takes 4 weeks. Endoscopy and blood work are taken before and after the~     treatment period.~   "
34092|NCT03120312|"~     The is a retrospective analysis to study the characteristics of elderly patients treated with~     total hip replacements during past 5 years．~   "
34093|NCT03120299|"~     The purpose of this study is to conduct a multicenter randomized, double-blind,~     placebo-controlled clinical trial, evaluating the effects and change of lipid metabolism,~     especially of triglyceride after omega-3 administration in type 2 diabetes patients with~     hypertriglyceride.~   "
34094|NCT03120286|"~     The effect of overweight and obesity on IVF outcomes is still questionable. The purpose of~     this study was to determine if overweight/obesity in women with PCOS were associated with an~     adverse IVF outcome compared to those with normal weight.~      Design: Retrospective cohort study.~   "
34095|NCT03120273|"~     This is a single center, open-label, multiple-dose phase 1 clinical trial. This study will~     determine the pharmacokinetics (PK), pharmacodynamics (PD), safety and side-effect profile of~     an investigational dexlansoprazole injection after multiple intravenous administration in~     healthy Chinese adults.~   "
34096|NCT03120260|"~     The purpose of the present study is to evaluate the effect of sleep duration on weight loss~     of obese and overweight adult when they are in a weight loss plan (NovinDiet Protocol). The~     investigators aim is to compare the effects of short term sleep duration with normal sleep~     duration with respect to body weight (and abdominal adiposity).~   "
34097|NCT03120247|"~     Oral trans-mucosal administration is relatively easy and convenient, it also reduces first~     pass metabolism and has been used successfully for fentanyl, ketamine, and midazolam~     premedication.~   "
34098|NCT03120234|"~     This study has been planned to compare the effect of opioid free anaesthesia using~     dexmedetomidine and ketamine with opioid based anaesthesia using fentanyl in maintaining the~     intraoperative hemodynamic stability and recovery characteristics in patients undergoing~     Transsphenoidal surgery of pituitary tumors.~   "
34099|NCT03120221|"~     Worldwide Data suggest that Iodine deficiency is a concern among healthy pregnant women.~     Thus, screening first trimester healthy pregnant women for iodine status is of clinical value~     for mother and child as iodine deficiency might have implications on thyroid function as well~     as pregnancy outcomes~   "
34100|NCT03120208|"~     The objective of this cross-sectional study is to assess the prevalence of depression at 2~     months, 6 months, and 1 year postpartum in women who had an immediate postpartum hemorrhage~     (immediate PPH defined as blood loss ≥ 500 mL within 24 hours of delivery). The potential~     serious consequences of PPH may lead to a greater number of psychological disorders in these~     women than in women without PPH.~   "
34101|NCT03120195|"~     The aim of this study is to assess the safety and feasibility of the EndoRotor® for the~     ablation of Barrett's esophagus.~   "
34102|NCT03120182|"~     The aim of this randomized, blinded, placebo controlled clinical study is to compare the~     peri- and postoperative bleeding and cardiovascular complication rates of patients undergoing~     burr-hole trepanation for chronic subdural hematoma with and without discontinuation of~     low-dose aspirin~   "
34103|NCT03120169|"~     Aim of this study is to investigate the effects of treadmill versus cycling endurance~     training on Balance, gait performance and exercise capacity in patients with severe chronic~     obstructive pulmonary disease. Patients will be recruited during a 3-week inpatient pulmonary~     rehabilitation program and will be randomized into one of two intervention groups. Walking~     intensity in the treadmill group will be set at 80 percent of the average speed of the~     6-minute walking test. The cycling group will exercise at an intensity of 60 percent~     according to an Initial incremental cycling test.~      Patients will perform 5 to 6 training sessions per week. The total exercise duration will be~     progressively increased from 10 to 30 minutes. Walking or cycling intensity will also be~     progressively increased if perceived exertion during exercise is rated below 3 on the~     modified 10-point Borg scale.~   "
34105|NCT03120143|"~     The effect of small-sided team sport training and protein intake on muscle mass, physical~     function, and adaptations important for health in untrained older adults was examined.~     Forty-eight untrained older (72±6 years) men and women were divided into either a team sport~     group ingesting a drink high in protein (18 g) immediately and 3 h after each training~     session (TS-HP, n=13), a team sport group ingesting an isocaloric drink with low protein~     content (3 g; TS-LP, n=18), and a control group continuing their normal activities (CON,~     n=17).~   "
34106|NCT03120130|"~     Amblyomin-X is an inhibitor of Factor Xa that also acts as an apoptotic agent for tumor~     cells. In the case of in vitro assays, Amblyomin-X induces tumor cells to death and does not~     affect the viability of normal cells. When in vivo assays were performed on mice bearing~     tumors, treatment with Amblyomin-X caused a significant reduction in tumor mass and number of~     metastases.~   "
34107|NCT03120117|"~     This is a prospective study to assess the feasibility and success of performing an~     intra-operative standing cough test and the correlation with the long term success of the~     sling surgery.~   "
34108|NCT03120104|"~     Fecal incontinence is common in patients with rectal cancer after surgery. Previous studies~     showed that pelvic floor muscle and external sphincter muscle training after stoma closure~     could improve the severity of incontinence and other fecal symptoms, but there is no study~     about the effects of pelvic floor muscle exercise intervention before stoma closure. We are~     wondering would the symptom of fecal incontinence recover sooner and better if we give the~     pelvic floor muscle exercise intervention before the stoma closure. This article aims at~     comparing the effects of pelvic floor muscle training before stoma closure on fecal~     incontinence (pre-intervention group) with pelvic floor muscle training after stoma closure~     (post-intervention group), and we hypothesise that the severity of fecal incontinence will~     improve sooner and better in pre-intervention group.~   "
34109|NCT03120091|"~     Real-time continuous glucose monitoring system (CGMS) has been attempted to be used in ICU,~     but its feasibility, accuracy and confounding factors are controversial.~   "
34110|NCT03120078|"~     Prospectively-Patients undergoing a hysterectomy for abnormal uterine bleeding (AUB) or~     pelvic pain will be enrolled in the study, will get pelvic ultrasound at the ultrasound~     clinic. An ultrasound will be obtained as part of the required clinical assessment before the~     patient undergoes a hysterectomy. The ultrasound images will be reviewed using Viewpoint~     reporting system-various sonographic features of adenomyosis will be reported detailed,~     including pelvic pathology, pelvic congestion syndrome etc. The histopathological examination~     will be done by assigned pathologist for accurate mapping/localizing the adenomyosis~     (appropriate section of uterus to defining localized versus generalized adenomyosis) on all~     patients diagnosed with adenomyosis on ultrasound. The ultrasound will be correlated with~     histopathology(which is the gold standard for diagnosis of adenomyosis). Scoring system for~     adenomyosis based on various sonographic features/clinical symptoms and their confirmation~     with histopathology will be developed.~   "
34111|NCT03120065|"~     The primary objective of this study is to use a well-characterized pediatric AMPATH cohort,~     with detailed medication-taking, drug level, and clinical data, to longitudinally evaluate~     treatment failure and drug resistance to improve long-term care for HIV-infected children in~     Kenya and other RLS. Examining treatment failure and drug resistance emergence in children on~     ART and what factors impact these negative outcomes, will provide needed data to critically~     evaluate the efficacy of current ART, weight-based pediatric drug dosing guidelines, and~     recommendations for subsequent therapies. The objective is to specifically characterize how~     non-adherence leads to a lack of viral suppression and to drug resistance evolution, and how~     this characterization can inform interventions to improve adherence and increase treatment~     success.~   "
34112|NCT03120052|"~     The overall goal of this study is to identify what Physical Therapy care components are~     associated with the best patient-reported functional outcome after Total Knee Replacement~     (TKR) surgery. The investigators are specifically looking at outcomes at 6 and 12 months~     after surgery.~   "
34113|NCT03120039|"~     To determine the criterion validity of the FitBit® Flex™ compared to the ActiGraph's~     Bluetooth® Smart wGT3X-BT wireless activity monitor, and contribute to the clinical utility~     of accelerometry measurement of UE movement.~   "
34114|NCT03120026|"~     This randomized, double-blind, placebo-controlled supplementation trial tested the hypothesis~     that nutritional supplementation with muscle-target nutritional supplementation concurrent~     with regular, controlled physical activity would increase the efficacy of physical~     rehabilitation in old adults suffering from sarcopenia~   "
34115|NCT03120013|"~     Neurodegenerative cerebellar ataxias represent a group of disabling disorders for which we~     currently lack effective therapies. Cerebellar transcranial direct current stimulation (tDCS)~     is a non-invasive technique, which has been demonstrated to modulate cerebellar excitability~     and improve symptoms in patients with cerebellar ataxias. In this randomized, double-blind,~     sham-controlled study, the investigators will evaluate whether a two-weeks' treatment with~     cerebellar anodal tDCS and spinal cathodal tDCS can improve symptoms in patients with~     neurodegenerative cerebellar ataxia and can modulate cerebello-motor connectivity, at short~     and long term.~   "
34116|NCT03120000|"~     An open-label, non-randomized, two-stage, multicenter study evaluating clinical efficacy,~     safety and pharmacokinetics of PQR309 in patients with relapsed or refractory Primary Central~     Nervous System Lymphoma (PCNSL).~   "
34117|NCT03119987|"~     Acute upper-gastrointestinal bleeding (UGIB) is a commonly encountered cause of admission in~     emergency department (ED). Early risk stratification allows appropriate therapy that may be~     helpful to advance the patient's morbidity and mortality. Investigators hypothesized that~     early RDW levels may have an independent, linear relationship with recurrent or massive~     bleeding in UGIB patients.~   "
34131|NCT03119805|"~     The purpose of this study is to define cut-off values of the most widely used composite~     scores and patient-reported outcomes, for levels corresponding to remission/low disease~     activity and for changes in levels corresponding to flares, in PsA, when remission/low~     disease activity and flare are defined from the patient and physician perspective. The ReFlaP~     (Remission/Flare in PsA) study is a prospective, multicentric international, longitudinal,~     observational study.~   "
34118|NCT03119974|"~     Thrombopoietin-receptor agonists (Tpo-RAs) have profoundly changed the management of ITP.~     However, today, there are no international recommendations concerning the long-term use of~     these costly, potentially pro-thrombotic agents, and that could induce bone marrow fibrosis~     in case of prolonged treatment. Tpo-RAs have been thought to play only a supporting role in~     ITP management. But our center along with many other research centers, have reported~     unexpected cases of durable remission after Tpo-RAs discontinuation in adult chronic ITP. In~     these retrospective studies, more than 20 % of patients were able to achieve prolonged~     remission.~      The purpose of this study is to demonstrate that a substantial proportion of ITP patients may~     achieve a prolonged response after Tpo-RA discontinuation.~      The investigators developed, in this study, a standardized procedure to discontinue~     Eltrombopag and Romiplostim, wherein the dose will be slowly tapered to limit the risk of~     bleeding. In case of relapse after Tpo-RA discontinuation, the decision to start a new~     therapy will be based on the clinician's judgment.~   "
34119|NCT03119961|"~     In Alzheimer's disease (AD) an imbalance between the production and clearance of the~     ß-amyloid peptide is hypothesized as the driving event of the disease. The decreased~     clearance of Aß could be partly linked to a progressive dysfunction of the brain vasculature~     and of the blood brain barrier (BBB). Among many possible explanations for these failures of~     the multiple clinical trials evaluating innovative drugs in AD, one is the lack of target~     engagement, as none of these drugs is able to readily cross BBB. This barrier acts as a wall~     that actively and passively prevents the crossing of molecules between the blood and the~     brain parenchyma compartments. Only 0.3% of intravenously injected anti-Aß immunoglobulins~     reach the brain despite a half-life of 15-20 days. Low intensity Focal ultrasound associated~     to microbubble injection can open the BBB in a non invasive way. These openings are~     reversible in 2 hours to 2 days depending on the intensity of the ultrasound. Ultrasound~     opening of the BBB was initially used in a transgenic mouse model of AD to increase the brain~     delivery of an anti-Aß antibody. In this article, the Aß load was reduced in ultrasound~     treated brain region. Surprisingly it was then demonstrated that the simple opening of the~     BBB without any adjunct anti-Aß treatment was able to drive the same Aß clearance effects.~     This is probably linked to endogenous antibodies that are able to penetrate the brain~     parenchyma and target Aß plaques. Four opening sessions elicited positive promnesic effects~     in these mice. Our group conceived and developed a mean to easily, reproductively and~     innocuously open the BBB. A unique extra-dural ultrasound emitter (sonoCloud®) is surgically~     implanted in the skull under local anesthesia. It emits low intensity contact ultrasound~     (LICU) that are not deterred by bone and thus are able to open the BBB.Preclinical studies~     show the SonoCloud® device is safe and efficient as it allowed reproducible and repeatable~     opening of the BBB in rabbits, dogs and non human primates. Drugs up to 2000 Kilo Daltons~     (kDa) are able to cross the BBB to reach the brain parenchyma in which the concentration of~     Carboplatin was increased by 700% in the BBB opened region. No adverse event was evidenced~     both clinically, by EEG, Evoked potential, MRI, 18 Fluorodeoxyglucose (FDG) PET and histology~     in the primates after 7 bi-monthly sessions of LICU BBB opening. SonoCloud® and its external~     generator have been certified by the academic start-up CarThéra (APHP, UPMC). Our~     multidisciplinary skills (neurology, neurosurgery, neuroimaging, basic science departments in~     the same University hospital setting) and our previous experience of BBB opening in Man give~     us the unique opportunity to translate this procedure from neuro-oncology to AD which could~     1) Have a positive effect on brain lesion load and symptoms by itself and 2) allow anti-AD~     (or more broadly, central nervous system) drugs to engage their targe~   "
34120|NCT03119948|"~     The most common motor deficiency after stroke or traumatic brain injury is hemiparesis. Most~     hemiparetic patients recover walking, but rarely with a speed permitting easy ambulation~     outdoors with family or friends. One of the mechanisms of gait impairment in hemiparesis is~     insufficient active hip flexion during swing phase, which leads to insufficient ground~     clearing at swing phase, with associated gait slowness and risks of fall.~      The main hypothesis behind the present study is that insufficient hip flexion during~     hemiparetic gait is partly due to overactivity of rectus femoris. Focal treatment of lower~     limb muscle overactivity using botulinum toxin has not been demonstrated to increase walking~     speed in hemiparesis as yet. However, most studies have focused distally, on improving foot~     dorsiflexion only. The purpose of this study is to compare the effects of botulinum toxin~     injection and placebo in rectus femoris (RF) + plantar flexors versus plantar flexors only.~   "
34121|NCT03119935|"~     This is a simulation study with a prospective randomized cross-over design. The aim of this~     study is to evaluate whether Amflow-assisted ambu-bag can delivery the accurate tidal volume~     compare to ordinary ambu-bag~   "
34122|NCT03119922|"~     The main objective of this study is to evaluate at the national level (France)~        -  the early healthcare practices for children with sickle cell disease screened at birth,~        -  the adequacy of theses practices with the national recommendations,~        -  their variability over time and according the characteristics of treatment centers.~      Will be studied in particular the diffusion of the latest preventive measures (practice of~     trans-cranial Doppler and pneumococcal conjugate vaccine) and their link with the residual~     risks of death, stroke and invasive pneumococcal infections. The study includes all patients~     born in France between 01/01/2006 and 31/12/2010. Events are recorded and analysed only~     during the first 5 years of life.~   "
34123|NCT03119909|"~     A hallmark of our survival in the real world and of our capacity to navigate the complex~     social interactions of human society is our ability to show behavioral adaptation. Adaptation~     can be necessary for a number of reasons, making the study of the process challenging. Two~     classes of event can signal a need for adaptation: 1) Events caused by one's own actions and~     specifically FeedBack -FB- from those actions (e.g. the investigators adapt their strategy~     after an erroneous choice), and 2) Events not linked to our actions, specifically~     Action-InDependent Events -AiDE- (e.g. the investigators adapt their strategy after a change~     of rule). These two types of information - FB and AiDE - will frequently occur concurrently.~     A critical and difficult part of adapting appropriately involves resolving the difference~     between the two. So for example an incorrect FB can occur because the investigators made an~     error, or because something unexpected in the environment has changed -the rule switched,~     someone cheated, etc. The Investigators must work out which it is, as they will frequently~     require different behavioral adaptations. Their task is made even more complex by the fact~     that the dynamics of evidence accumulation after FB vs AiDE are very different. FB has a~     direct temporal and causal link to an executed action, which means that the investigators are~     certain to derive information about a given action from a given FB. In contrast, AiDE have no~     such contiguity and no initial relation to actions, which means that the investigators must~     accumulate evidence to identify the appropriate adaptation to an AiDE. So the crucial dilemma~     is this: after an unwanted outcome, should the investigators adapt as if they made an error~     and received a negative FB, or should they continue to accumulate evidence as if there has~     been an AiDE to which they need to know how to adapt. Animals are able to resolve this credit~     assignment problem, as evidenced by their ability to appropriately adapt their behavior. A~     breakdown of this ability to link unexpected events to their correct cause would seem to be~     at the source of impairments in a wide range of psychological and neurological disorders,~     from addiction and OCD to psychological symptoms in Parkinson's disease. Yet the neural basis~     of this process is currently unknown, and FB and AiDE processing have been assessed~     separately so far. ADAPCO will provide unprecedented characterization of brain systems~     critically involved in learning from and adapting to FB, AiDE, and their interactions, thanks~     to fMRI studies.~   "
34124|NCT03119896|"~     Does the Navigator Tool Intervention improve communication regarding self-management during~     consultations between healthcare professionals and people with chronic pain?~      As there is usually no cure for chronic pain, healthcare professionals are increasingly~     turning to methods of treatment that emphasise management of symptoms rather than elimination~     of pain. However, as Pain Concern's previous research has shown, there are several barriers~     to self-management that both healthcare professionals and people with pain face in their~     consultations in primary care. The Navigator Tool Intervention has been designed to overcome~     the majority of these barriers through improving the quality of communication regarding~     self-management during consultations.~      In line with the House of Care Model, where care relies on engaged and informed patients,~     healthcare professionals committed to partnership working, and organisational processes that~     support this, our intervention prepares both the healthcare professionals and patients for~     their consultation. By providing a training session for the healthcare professionals in how~     supported self-management can be brought into the consultation room, and by providing the~     patients with a paper-based tool that allows them to organise their concerns and questions~     prior to the consultation, the intervention aims to steer the conversation toward the aspects~     that the patient needs to discuss in order to better manage their pain.~      This study will launch the intervention and evaluate its effectiveness in improving~     self-management support through conversation. It will be launched over a 3 month period in 4~     sites across Scotland; 24 patients will be using the tool with a trained healthcare~     professional and 24 will act as a control group, receiving standard care without the tool.~      Questionnaires assessing the satisfaction with the consultation(s) and communication, as well~     as confidence in managing one's pain, will be analysed and compared between the two groups.~     Interviews will be carried out with healthcare professionals and a sample of patients having~     used the tool to gain a deeper understanding of the usefulness of the intervention and how it~     may be improved in the future.~   "
34125|NCT03119883|"~     The utilization of glutamine by the bone marrow plasma cells in MGUS and MM will be compared~     between each other after infusion of 13-carbon labelled glutamine.~   "
34132|NCT03119792|"~     In May 2009 in Bogota, Colombia, the Si! program conducted a cluster randomized trial in 1216~     children between the ages of 3 and 6 years old, and 928 parents with the aim of evaluating a~     five month education intervention to change knowledge, attitudes and habits related to a~     healthy diet and active lifestyle in preschoolers. The results showed that the program was~     feasible and effective. The Si! Program will perform a new follow up of its original children~     cohort, now between the ages of 9 and 13 years. The original cohort will be compared to a new~     comparable cohort to assess baseline knowledge, attitudes and habits of healthy lifestyles in~     knowledge, attitudes, habits and emotions towards a healthy lifestyles . A community~     pedagogical intervention in healthy lifestyles on cardiovascular health will be implemented~     in the intervention group.~   "
34126|NCT03119870|"~     Efficient evaluation and monitoring of actions and outcomes are a key feature of primates'~     efficient adaptive cognition. Deficits in evaluating one's own actions and their consequences~     is a key feature of prominent disorders such as obsessive compulsive disorders (OCD),~     schizophrenia, and anxiety. The Investigators know that these evaluative processes implicate~     medial structures of the brain that are related both to old limbic functions and to more~     recently evolved higher executive functions. Brain potentials related to performance~     monitoring have attracted a lot of interest in cognitive neuroscience but also in the~     clinical domain because they appear to be altered in different neurological or psychiatric~     disorders, such as schizophrenia, OCD, or anxiety, and could become biomarkers of~     pathologies. But the neural sources of these markers are not fully determined and are~     currently highly debated. In addition, our work suggests that non pathological factors, such~     as normal morphological cortical variations, could affect those markers. Understanding~     performance monitoring, acting directly on medial cortex, or using electrophysiological~     markers in clinic are thus currently problematic and challenging. This is mostly because~     structure-function relationships in the medial wall are ill defined for historical,~     conceptual, and methodological reasons. Importantly, although individual variability of brain~     morphology impedes precise assessment of structure function relationships, this variability~     is almost never taken into account. EEG-Feedback aims to resolve these issues by evaluating~     the consequences of individual variability in cingulate cortex morphology on 1) surface EEG~     markers of feedback monitoring and 2) functional connectivity patterns thanks to~     resting-state fMRI.~   "
34127|NCT03119857|"~     Summary~      In patients with prostate cancer (PC) who have only biochemically relapsed disease after~     curative treatment (or some locally advanced PC patients), hormonal therapy remains a de~     facto standard of care treatment. Adding docetaxel-based chemotherapy to a standard-of-care~     hormonal therapy has an increased potential to treat prostate cancer cell clones resistant to~     androgen withdrawal and to possibly shorten the duration of therapy needed to control the~     disease.~      This clinical trial is designed on the basis of an unmet clinical need, as well as other~     factors including: 1) a consensus among investigators on endpoints for studies of patients~     with a rising PSA, 2) the ability to identify subjects at high risk for developing~     radiographic metastases, 3) the fact that hormonal therapy has already been shown to improve~     survival when applied early in the natural history, and 4) the availability of chemotherapy~     such as docetaxel that can improve survival in subjects with advanced disease.~      It is our hypothesis that a more appropriate group of patients who may benefit from the~     curative potential of systemic chemo-hormonal modality is that with minimal, but detectable~     disease who have a high probability of developing metastatic disease, clinical symptoms and~     eventually death from prostate cancer in a defined time frame. The investigators hypothesize~     further that the approach is likely to be more effective at a time of minimal tumour burden,~     resulting in minimization of the overall burden of therapy and better quality of life while~     on treatment.~      This trial will determine whether any benefit is gained by adding chemotherapy to hormonal~     therapy alone in the population of subjects with a rising PSA. Two therapeutic approaches~     will be compared in this two-arm randomized clinical trial. The control Arm A provides~     antiandrogen (bicalutamide 150 mg x 1) alone. The experimental Arm B involves treatment with~     docetaxel for 8-10 cycles and antiandrogen (bicalutamide 150 mg x 1) treatment. For the~     schematic representation of study design please see Section 7.3.1.~      Subjects with a rising PSA following definitive local curative therapy will be eligible, if~     their PSA doubling time is < 12 months. Also PC patients planned for anti-.androgen therapy~     are eligible, with the same criteria. Subjects with radiographic metastases will be excluded.~     The primary endpoint of the trial is progression-free survival of subjects that do not~     experience biochemical failure at 60 months from the start of therapy.~      Based on the yearly number of prostate cancer patients who undergo definitive local therapies~     and the estimated probabilities of relapse, upwards of 400 men (if +15% improvement) in the~     Scandinavian countries are potential candidates for this approach.~   "
34128|NCT03119844|"~     Heart failure affects not only the cardiovascular system with structural abnormalities of the~     heart, but also the musculoskeletal system, leading to exercise intolerance. Objective: To~     evaluate the effects of a short-term exercise protocol and phototherapy, on the functional~     capacity and inflammatory markers in patients with heart failure. In addition, the~     investigators will investigate pulmonary function, peripheral and respiratory muscle strength~     and quality of life. Methods: Heart failure patients (left ventricular ejection fraction <~     40%) will be selected from the outpatient clinic of the myocardium of the Department of~     Cardiology of Unifesp and randomized among two groups: patients who will be submitted to~     placebo phototherapy and cycle ergometer exercise; and patients who will be submitted to~     active phototherapy and cycle ergometer exercise. All groups will receive treatment twice a~     week for four weeks. Patients will be instructed to conduct home-based walking program at~     least twice a week. Patients will be evaluated before and after protocols regarding the~     pulmonary function, peripheral and respiratory muscle strength, functionality, quality of~     life and evaluation of systemic inflammatory mediators.~   "
34129|NCT03119831|"~     Aim: This study compared the effectiveness of three different mouthrinses (alcohol and~     non-alcohol chlorhexidine, alkyl dimethyl glycine / alkyl dimethyl amine oxide - C31G) in~     plaque control and early wound healing, postoperatively.~      Materials and Methods: In this, randomized, double-blind, controlled clinical trial 42~     patients were allocated to three groups assigned to two weeks rinsing after periodontal~     surgery with C31G (group A), alcohol-free chlorhexidine 0.12% (group B) or alcohol-based~     chlorhexidine 0.12% (group C). At weeks 1 and 2, plaque and early wound healing indices were~     recorded. At day 14, total bacterial counts were estimated utilizing real - time qPCR.~     Statistics included linear and generalized linear mixed models.~   "
34130|NCT03119818|"~     End-stage renal disease is associated with hyperphosphatemia due to a decrease of renal~     phosphate excretion. This hyperphosphatemia is associated with an increase of cardiovascular~     risk and mortality. Thus, three therapeutic options have been developed: dietary restriction,~     administration of phosphate binders and phosphorus clearance by hemodialysis (HD).~      During a standard HD session, around 600 to 700mg phosphate is removed from the plasma,~     whereas it contains only 90 mg inorganic phosphate (Pi); 85% of phosphate is stored in bones~     and teeth in hydroxyapatite form, 14% is stored in the intracellular space (90% organic~     phosphate and 10% Pi), and 1% remains in the extracellular space.~      Currently, the source of Pi cleared during HD remains to be determined. Phosphorus (31P)~     magnetic resonance spectroscopy allows reliable, dynamic and non-invasive measurements of~     phosphate intracellular concentration. The investigator's team recently published data~     obtained in anephric pigs, suggesting that phosphate intracellular concentration increases~     during a HD session. In parallel, we showed that ATP intracellular concentration decreased.~     These results suggest that the source of Pi cleared during HD could be located inside the~     cell.~      In this study, investigators will measure intracellular phosphate and ATP concentrations and~     intracellular potential of hydrogen (pH) evolution during hemodialysis in 12 patients~     suffering from end-stage renal disease by MR spectroscopy.~      If these results were confirmed in humans, it could explain, at least in part, HD intolerance~     in some patients and would lead to modify therapeutic approaches of hyperphosphatemia, for~     example, by modifying HD sessions time.~   "
34180|NCT03119155|"~     The objective of this study is to improve the diagnosis level of fetal congenital heart~     disease by the multi-center collaboration in China.~   "
34133|NCT03119779|"~     Objective:~      To assess which is the most efficient pulpotomy medicament on tooth survival in patients with~     a cariously-exposed vital young permanent molar regarding: absence of postoperative pain,~     sinus or swelling, internal/ external root resorption, periapical radiolucency), root~     maturation and decrease chair side time of treated patient.~      Trial design Randomized Clinical Trial (RCT), double-blinded with parallel group and~     allocation ratio (1:1), equivalence framework.~   "
34134|NCT03119766|"~     Purpose of the study:~      To obtain additional data on efficacy and safety of Kolofort in functional dyspepsia patients~   "
34135|NCT03119753|"~     In this study we are going to compare dimensional accuracy of maxillary complete denture base~     fabricated by using rapid prototyping method and conventional method.~      We hypothesize that both techniques do not significantly differ from each other~   "
34136|NCT03119740|"~     The frequency of complications after appendectomy is about 9% . The predictive value of CRP~     as an indicator of postoperative complications has been addressed in a small number of~     studies. The aim of the present retrospective analysis was to determine whether postoperative~     CRP levels are a reliable predictor of postoperative complications.~   "
34137|NCT03119727|"~     Evaluation of automatic titration of oxygen with a new version of FreeO2 (V4)~   "
34138|NCT03119714|"~     The purpose of this study is to establish the influence of the non-steroidal candidate-drug~     pemirolast on allergen-induced airway obstruction and inflammation in allergic subjects with~     asthma. Pemirolast is an orally available inhibitor of the release of mast cell mediators.~     The study will therefore test the hypothesis that global inhibition of the mast cell,~     resulting in decreased production of most of its mediator molecules, will provide a highly~     significant anti-asthmatic effect.~   "
34139|NCT03119701|"~     A study to assess effectiveness and safety of a drug FP-1201-lyo (Recombinant Human~     Interferon Beta-1a) in the Prevention of Multi-Organ Failure on patients after Open Surgery~     for a Ruptured Abdominal Aortic Aneurysm~   "
34140|NCT03119688|"~     The objective of this clinical study is to assess the relative mildness of a cosmetic facial~     cleanser in comparison to water through repeated application to the volar forearm using the~     FCAT wash procedure.~   "
34141|NCT03119675|"~     Objective: Prospective evaluation of GoCheckKids™, a smartphone application ('App') as a~     photo screening device in a pediatric population to detect amblyopia risk factors (ARFs)~      Method: Photorefraction images are captured using up to 4 different devices with GoCheckKids™~     App and patients are evaluated with cycloplegic refraction.~   "
34142|NCT03119662|"~     This parallel-group, randomized, placebo-controlled study will examine the incidence and~     severity of acute kidney injury (AKI) in patients with chronic kidney disease (CKD) stage~     III/IV following an i.v. injection of iso-osmolar iodinated contrast material iodixanol~     (Visipaque™ Injection 320 mgI/mL), as compared with patients who received saline and~     underwent a non-enhanced CT (NECT) and duplex ultrasound (US) during their scheduled~     post-EVAR surveillance imaging.~   "
34143|NCT03119649|"~     This is a Phase IIa, multi-center, randomized, double-blind, placebo-controlled,~     parallel-group study to evaluate 4 different doses of GLPG2222 administered for 4 weeks to~     adult subjects with a confirmed diagnosis of CF and homozygous for the F508del CFTR mutation.~   "
34144|NCT03119636|"~     This study will evaluate the safety and efficacy of intracerebral transplantation of human~     embryonic stem cells-derived neural precursor cells in patients with Parkinson's Disease.~   "
34145|NCT03119623|"~     PARADOR is multisite, randomized, double-blind, phase IV clinical trial to compare the effect~     of sacubitril/valsartan (Entresto™) to enalapril (Vasotec®) on blood vessel function in~     subjects with heart failure with reduced ejection fraction (HFREF).~   "
34146|NCT03119610|"~     Obesity is highly prevalent in older adults and is a major cause of sarcopenia and disability~     in older adults. Although exercise can counteract the effects of obesity and sarcopenia, many~     have difficulty adhering to an exercise program and the benefits of exercise are variable.~     Therefore, there is an urgent need to test novel pharmacologic interventions to prevent~     disability and loss of independence. Oxytocin is a pituitary hormone released during~     parturition and lactation that is also known to suppress appetite in rodents and humans; and,~     recent small studies have found that intranasal oxytocin reduces body weight in adults. We~     propose a pilot study of intranasal oxytocin as a novel approach to promote weight loss and~     increase muscle mass in older subjects with sarcopenic obesity.~   "
34147|NCT03119597|"~     The purpose of this study is to determine whether a 4-week dietary intervention with wild~     blueberry powder can have an effect on cognitive performance in participants aged between~     13-17.~   "
34148|NCT03119584|"~     Study includes 5 visits, when all basic clinical information, vital signs, symptoms, and side~     effects are going to be assessed at each appointment.~      Patients are going to be assigned by the computer, to receive an active or non-active drug~     for 14 days in a first phase. The order will be change during the second phase. The 2 weeks~     break without our medication will separate these phases. A very close observation regarding~     safety of our subjects will be implemented by study personnel and clinical investigators.~   "
34149|NCT03119571|"~     To determine if survival to hospital discharge with good neurological outcome for adults ages~     18-75 who are resuscitated from out-of-hospital VT/VF cardiac arrest without clinical signs~     of a heart attack do better by going straight to the cardiac catheterization laboratory or~     admitted to the intensive care unit for evaluation. The investigators think a large portion~     of resuscitated patients presenting with VT/VF have ischemic heart disease which is the cause~     for the arrest. And prompt access to the cardiac catheterization laboratory to reverse the~     blocked artery will improve survival with good neurological outcomes.~   "
34150|NCT03119558|"~     Cardiac amyloidosis is a disorder characterized by the deposition of abnormal proteins called~     amyloid in the heart tissue. This makes it difficult for the heart to function properly. The~     investigators wish to evaluate if the radiopharmaceutical 18F‑Florbetaben (Neuraceq®) that~     targets beta amyloid can also identify cardiac amyloid deposition.~   "
34191|NCT03119012|"~     This study aimed to compare the efficacy and safety of P2Y12 inhibitor monotherapy versus~     extended dual antiplatelet therapy (DAPT) following 12-month of DAPT in patients undergoing~     percutaneous coronary intervention (PCI) with bioresorbable scaffold (BRS)~   "
34192|NCT03118999|"~     The primary objective of this study is to evaluate the pharmacokinetic properties of 3 OM3~     oils after a single-dose administration in healthy volunteers~   "
34151|NCT03119545|"~     The overall purpose of this project is to evaluate a family-centered intervention (the Family~     Talk Intervention, by W. Beardslee) in families where a parent of children aged 6-19 years is~     seriously ill and cared for in specialized homecare. The aims of the intervention are to~     increase family communication, the families' awareness of the impending death and their~     knowledge about the cancer illness, and thereby reduce the family members' long-term~     psychological distress.~   "
34152|NCT03119532|"~     Over 40 million major operative procedures are performed in the US annually and comprise~     about 40% of healthcare expenditures. Despite decades of research, perioperative mortality~     and morbidity remain a major healthcare system cost and detriment to long-term quality of~     life. More than ten percent of patients experience a significant event such as surgical site~     infection, reoperation, myocardial infarction, pulmonary embolus, or death. Nearly 100,000~     patients die after surgery each year. National data demonstrate a 3-fold variation in risk~     adjusted surgical morbidity and mortality, suggesting many opportunities for improvement in~     perioperative care.~      Anesthesiology care demonstrates wide variation in practice. Sometimes, this variation is~     appropriate because the anesthesiologist is responding to patient comorbidities or procedure~     specific events. However, even after controlling for patient specific factors, there is a~     substantial amount of unexplained variation in fundamental elements of anesthesiology care.~     The same procedure and patient can be performed using completely different anesthetic~     techniques, hemodynamic management strategies, and medications. This variation in care can~     lead to a variation in outcome.~      The use of electronic health records (EHR) with detailed preoperative and intraoperative data~     allows an automated system to be developed to notify clinicians their compliance to both~     process of care metrics and outcome metrics. The Multicenter Perioperative Outcomes Group~     (MPOG) quality improvement arm is known as Anesthesiology Performance Improvement Reporting~     Exchange (ASPIRE). Like other Collaborative Quality Initiatives, the primary goal of ASPIRE~     is to provide hospitals with risk-adjusted feedback on outcome and process of care variation.~     In addition, ASPIRE creates an active best-practice sharing environment to enable data to~     spur action. Recent literature has demonstrated that hospital-level feedback may not be~     adequate to improve performance and clinical outcomes. In addition to hospital level data and~     feedback, ASPIRE can disseminate provider-specific electronic feedback that may decrease~     variation in care known to impact complications and cost.~      The primary aim for this research study on ASPIRE's QI program is to determine if the~     investigators can change behavior as measured by a provider's compliance to specific~     performance metrics. The investigators believe that the start of individual provider~     performance feedback reports to ASPIRE members presents a unique opportunity to research the~     efficacy of these novel tools. The investigators propose to test the hypothesis that monthly~     provider specific feedback emails on ASPIRE quality metrics over a period of 9 months~     improves provider compliance as measured by a either a 10% improvement in the Total~     Performance Score or by moving from below to above the 90% performance threshold in the Total~     Performance Score Index.~      Each provider type (faculty, CRNA, resident/fellow) within a hospital participating in ASPIRE~     will be individually randomized to either receiving the electronic performance improvement~     email or not for a total of nine months. No individual at the participating site will see the~     individualized email compliance reports except for the specific provider. Only an aggregate~     of the compliance across the entire hospital will be supplied to the chairperson and the~     quality assurance directors. After the completion of the nine month randomization period, all~     providers will receive monthly ASPIRE performance improvement emails.~      The University of Michigan is the coordinating center but also participating in this research~     on QI project. De-identified patient data will be pulled in aggregate for each provider using~     the MPOG database. The provider performance for each measure will then be sent from ASPIRE to~     the randomized care provider via an email. The chairperson and quality assurance directors~     will only see aggregate data on compliance rates and can NOT identify individual compliance~     rates. Each participating site will obtain their own institutional IRB to participate in this~     study.~   "
34153|NCT03119519|"~     Aggressive therapy may improve survival in synchronous oligometastatic NSCLC and the goal of~     this clinical trial is to assess the efficacy and safety of local definitive radiotherapy in~     this subset of patients.~   "
34154|NCT03119506|"~     This study aims to understand the interaction between school recess activity and duration and~     lunch choices among elementary school children~   "
34155|NCT03119493|"~     Autonomic disfunction present in metabolic syndrome subjects is related by a greater~     vulnerability of the heart and risk of cardiovascular events. In this context, aerobic~     interval training has been highlighted by its easy applicability and benefits effects in~     autonomic modulation in different populations. Therefore the studies that use de aerobic~     interval training in this different populations didn't realize a periodization of training~     with preparatory periods with progressive increase of load, specific phases with less~     duration predominating the intensity and transition periods for recuperation. Additionally,~     there isn't studies that investigate the effects of aerobic interval training in autonomic~     modulation of individuals with metabolic syndrome. In this context, periodized aerobic~     interval training can arise like a new type of treatment that offering security and efficacy~     in subjects with metabolic syndrome. So, the aim of the study is evaluate the effect of~     periodized aerobic interval training in cardiac autonomic modulation and cardiovascular and~     anthropometric parameters of individuals with metabolic syndrome.~   "
34156|NCT03119480|"~     To set up electronic early warning system of AKI patients; To develop AKI's intervention, the~     follow-up process, and the renal physician is responsible for the implementation.~      To Observe the method after implementing the treatment efficacy of AKI and the differences~     between the traditional treatment process.~   "
34157|NCT03119467|"~     A Phase I/Ib, Study to Evaluate Safety and Efficacy of RP4010, in Patients with Relapsed or~     Refractory Lymphomas~   "
34158|NCT03119454|"~     Evaluation of pharmacokinetic parameters of diprospan in long term when administered~     systemically in patients in routine medical practice.~      Applied research project.~      Design: open-comparative prospective cohort study.~      Two groups of subjects:~        -  patients who are receiving diprospan in standard therapy of their existing disease, or~          multiple times, but following the introduction of diprospan is planned no earlier than~          28 days after the first,~        -  control group of subjects for the study of pharmacokinetic parameters diprospan and its~          metabolites.~      Objectives of the study: to evaluate the pharmacokinetic parameters of Diprospan in the long~     term when administered systemically in patients in routine practice.~   "
34159|NCT03119441|"~     The aim of this study is to assess the efficacy of dental water jet in plaque removal and~     gingival health during orthodontic treatment with fixed appliances.~   "
34160|NCT03119428|"~     The purpose of this study is to evaluate the safety and efficacy of OMP-31M32. OMP-313M32 is~     an experimental anti-TIGIT antibody that was developed to block TIGIT from binding PVR~     allowing the body's T-cells to destroy cancer cells.~   "
34161|NCT03119415|"~     Students' cooperative and prosocial behavior is vital to their social and academic success~     and to the quality of a school's social environment. This project will evaluate an~     instructional technique that could benefit students and schools by encouraging higher levels~     of prosocial behavior among students and promoting social integration and inclusion,~     particularly for marginalized students. The instructional technique is called cooperative~     learning which involves students working in groups toward shared academic goals. Previous~     research indicates that cooperative learning promotes social acceptance and increases~     academic engagement and achievement. However, it has not been evaluated as a technique to~     reduce student behavioral problems and promote greater school safety. There is strong reason~     to believe that it will have these benefits, since cooperative learning brings together~     students from diverse social groups and provides them the opportunity to work together toward~     shared goals in a positive setting.~   "
34162|NCT03119402|"~     The purpose of the study is to evaluate the effectiveness of the combination of Rhythmic~     Reading Training (RRT), a computer-assisted intervention method that combines sublexical~     reading exercises with rhythm processing, and transcranial direct current stimulation (tDCS)~     on reading abilities of a group of Italian undergraduate students with dyslexia. Two~     experimental conditions (active vs. sham) will be compared. Finally, the effects of the~     intervention on other cognitive functions involved in the process of reading (i.e., rapid~     automatized naming, verbal working memory, rhythm perception abilities) will be measured.~   "
34163|NCT03119389|"~     The necessity of Hand hygiene (HH) before donning non-sterile gloves is unknown. Furthermore,~     because of the additional time required to cleanse hands and then don gloves, as well as the~     cumbersome nature of applying gloves to recently washed hands, this practice leads to~     non-compliance with both HH and glove use - placing patients at risk. In a pilot study, the~     investigators performed a randomized trial of 230 healthcare workers and demonstrated no~     difference in total bacterial colony counts or identification of pathogenic bacteria from the~     gloves of persons who either performed HH or did not perform HH prior to putting on~     non-sterile gloves. If unnecessary, HH before non-sterile glove use wastes valuable time,~     which might otherwise be spent engaged in direct patient care. And removing this unnecessary~     step may lead to increased compliance with infection prevention measures. In Aim A, the~     investigators will perform a multi-center randomized control trial to evaluate the efficacy~     of a direct gloving strategy to improve compliance with infection prevention practices. In~     Aim B, the investigators will perform a nested multi-center validation study, where the~     gloved hands of healthcare workers will be randomly sampled to determine bacterial~     contamination of non-sterile gloves after donning.~   "
34210|NCT03118765|"~     Pharmacodynamic and Pharmacokinetic Dose Ranging Study of Tiotropium Bromide Administered Via~     Inhalation Solution in Patients With Chronic Obstructive Pulmonary Disease (COPD).~   "
34164|NCT03119376|"~     The peer review process is a cornerstone of biomedical research publication. Despite being~     essential, the assessment of the completeness of the reporting and the identification of~     switched outcomes are not appropriately performed. Furthermore, these tasks do not suppose a~     high level of expertise and could be performed by junior researchers.~      To assess the completeness of reporting and identified switched outcome(s), junior peer~     reviewers could use a simple online tool (COBPeer) based on the CONSORT (Consolidated~     Standards of Reporting Trials) 2010 checklist and Elaboration and Explanation publication for~     reporting parallel-group RCTs. The tool would feature bullet points eliciting the meaning of~     each checklist item. The aim of this study that will compare the accuracy of junior peer~     reviewers using the tool to that of usual peer reviewers when evaluating the completeness of~     reporting and switched of primary outcome(s) in reports of RCTs~   "
34165|NCT03119363|"~     Cancer related fatigue (CRF) is the most common cancer side effect and can severely interfere~     with activities of daily living long after completion of medical treatment. Pharmacologic~     agents to treat CRF have been studied but there is insufficient evidence to recommend their~     use. Non-pharmacological interventions for CRF have also been studied but are costly to~     implement and involve significant patient burden. This study investigates a novel low-cost/~     low-burden intervention: systematic light exposure to treat CRF. Two hundred survivors of~     multiple myeloma and Diffuse Large B-cell Lymphoma between 1 month and 5 years~     post-autologous stem cell transplant (ASCT) will be recruited from two medical centers. The~     light will be administered by a small, personal Litebox daily for 4 weeks. Outcomes will be~     assessed at five separate time points, including baseline and follow-up. The study will~     specifically address recommendations made for interventions for CRF from the NCI Clinical~     Trials Planning meeting (JNCI, 2013).The proposed study will: 1) be the first large multisite~     study with a carefully delineated comparison condition to investigate the effects of light on~     CRF among ASCT survivors; 2) focus on a distinct, homogenous patient population; 3) include~     only survivors who experience clinical levels of CRF; and 4) address possible psychological~     and biological mechanisms. This study will have major public health relevance as it will~     determine if an easy-to-deliver, inexpensive, and low patient burden intervention effectively~     reduces CRF.~   "
34166|NCT03119350|"~     Considering that the failure of the treatment of obesity is justified by the multifactorial~     pathophysiology of this morbidity, the present project has the following hypotheses:~        1. The occurrence of obesity is due to the derange,ent of mitochondrial energy metabolism ;~        2. The unbalance is therapeutically modified through physical training ;~        3. Obesity courses with the break-down in energy metabolism mitochondrial disease~          associated with systemic inflammatory characteristics that can be corrected through a~          combined long-term physical training program.~      This study have as objective : to analyse changes in mitochondrial function, inflammatory~     profile, oxidative stress and energy metabolism caused by concurrent physical training in~     obese women.~   "
34167|NCT03119337|"~     Voluntary medical male circumcision (VMMC) in sub-Saharan Africa is safe: the average rate of~     moderate and severe adverse events (AEs) at the country level is 0.8%, corresponding to 99%~     of men healing without incident. To reach the global target of 20 million by 2018, VMMC~     productivity needs to double in countries already plagued by severe healthcare worker~     shortages like Zimbabwe. The ZAZIC consortium partners with the Zimbabwe Ministry of Health~     and Child Care (MoHCC) and performed over 120,000 VMMCs. Current VMMC care in Zimbabwe~     requires in-person, follow-up visits at post-operative days 2,7, and 42. Over 95% adhere to~     multiple follow-up visits within 14 days of VMMC. ZAZIC's program has an overall AE rate of~     0.4%; therefore, overstretched clinic staff conducted more than 200,000 unnecessary reviews~     for VMMC clients without complications. High mobile phone ownership, severe healthcare worker~     shortages, and rapid VMMC scale up make ZAZIC's VMMC program an ideal setting to test a~     mobile health (mHealth) intervention to reduce provider workload while safeguarding patient~     safety. Through an un-blinded, prospective, randomized, control trial (RCT) in high-volume~     facilities providing VMMC, ZAZIC will implement an interactive, two-way texting (2wT)~     intervention to identify men healing without complication, allowing them to decline routine~     in-person follow up visits. 2wT will simultaneously identify men with any sign of an adverse~     event, encouraging rapid in-person follow-up when an AE is suspected on any day, reducing~     unnecessary visits while maintaining quality care. We aim to 1) determine if 2wT can safely~     reduce VMMC follow-up visits; 2) estimate the cost savings associated with 2wT over routine~     VMMC follow-up; and 3) assess the acceptability and feasibility of 2wT for further scale-up.~     It is expected that this intervention with be as safe as routine care while providing~     distinct advantages in terms of efficiency, costs, and reduced healthcare worker burden. This~     approach is innovative as it focuses on using a low-cost mHealth intervention to reduce~     provider workload without deterioration in quality care. The success of this intervention~     could lead to adoption of this intervention at the national level, increasing efficiency of~     VMMC scale up and reducing burdens on providers and patients~   "
34168|NCT03119324|"~     The Low Level Laser Therapy (LLLT) has been recently introduced with success in the~     management of the pain associated to this condition. This double blind placebo controlled~     clinical trial analyzes a new home LLLT protocol to verify whether it was possible to avoid~     to the repeated presence at dental chair required by traditional LLLT protocols.~   "
34169|NCT03119311|"~     Thirty-four subjects with constant exotropia were included. Two independent ophthalmologists~     measured the angle of ocular deviation using alternate prism cover test (APCT). The video~     files and data with the changes in ocular deviation during the alternate cover test were~     obtained using video-oculography (VOG). To verify the accuracy of VOG, Investigator compared~     the value obtained using VOG and the angle of a rotating model eye, and subsequently made a~     new linear equation using these data. The calculated values obtained using VOG were compared~     with those obtained using APCT to determine the diagnostic accuracy of VOG.~   "
34170|NCT03119298|"~     The study's aims are twofold: First, to examine physiological correlates of fear of physical~     activity (PA) and second, to examine correlates between fear of PA and interoceptive~     abilities in patients with chronic heart failure compared to healthy persons. Patients' fear~     of PA will be assessed via the Fear of Activity in Situations - Heart Failure (FActS-HF)~     questionnaire. The patient group will be split into two subgroups: One with high fear of PA~     and the second with low fear of PA based on FActS-HF scores (first control group). Fear of PA~     will be assessed via an adapted version of FActS-HF in a sample of healthy persons (second~     control group). Each member of the high-fear-of-PA group will be individually matched with~     one member of the second control group, based on sex and age. The participants of all three~     groups undergo the same experimental trials.~      Aim 1: The startle paradigm will be used to investigate the physiological component of fear~     of PA. The startle paradigm is based on empirical observations that the startle reflex is~     larger after the priming with unpleasant stimuli and inhibited after the priming with~     pleasant stimuli. The participants will be primed with various words including those words~     associated with physical activity that are expected to be unpleasant in patients with high~     fear of PA. The startle reflex will be triggered by air puffs on the eyes (startle probes)~     and measured via facial electromyography (EMG). We assume that startle responses primed with~     PA related words are stronger in patients with high fear of PA compared to the control~     groups.~      Aim 2: Interoceptive accuracy will be assessed via the Schandry test and interoceptive~     awareness will be assessed via the Multidimensional Assessment of Interoceptive Awareness~     (MAIA) questionnaire. During the Schandry test the participants will be instructed to~     subjectively count their heart rate without any aid or tools. The heart rate will be~     objectively measured at the same time via ECG. A high congruence of the objective and~     subjective results indicate a high interoception ability, and is assumed to be correlated~     with high fear of physical activity. Additionally, we expect positive correlations between~     the MAIA and FActS scores.~   "
34171|NCT03119285|"~     The investigators propose to test for non-BRCA1/2 mutations in new and existing families with~     hereditary ovarian cancer in order to better define penetrance and associated malignancies of~     rare ovarian cancer susceptibility genes. The hypothesis is at least one third of hereditary~     ovarian carcinoma families wildtype for BRCA1/2 can be solved using an updated version of~     BROCA (BROCA-HR) that targets 47 genes, including all known ovarian cancer genes and~     additional candidate genes in related pathways. The objective is to identify families with~     mutations in rare ovarian cancer susceptibility genes and test both affected and unaffected~     family members, thereby generating a rough estimate of penetrance for each mutated gene as~     well as identify new ovarian cancer susceptibility genes. The investigators also plan to~     enroll self identified African America women, who have been drastically under-represented in~     clinical cancer genetic testing programs and in OC susceptibility research.~   "
34172|NCT03119272|"~     The purpose of this research study is to analyze the microorganisms residing in the gut of~     patients with anorexia nervosa. Research has begun to link changes in the intestinal~     microbiota with diseases such as inflammatory bowel disease (IBS), asthma, and obesity, but~     although some studies have investigated the intestinal microbiota in overweight/obese~     individuals, very little is known about the intestinal microbiota in underweight individuals.~     The investigators aim to identify the enteric bacterial groups associated with adiposity,~     BMI, anxiety, and stress in patients with anorexia nervosa.~   "
34173|NCT03119259|"~     The primary purpose of this study is to test whether coupling of a mobile health technology~     application (HABC 2.0) with the Aging Brain Care (ABC) Clinical Program improves (1) the~     behavioral and psychological symptoms of patients suffering from Alzheimer's disease and~     related dementias (ADRD) and (2) the distress of their informal caregivers.~      Hypothesis #1:Patients who receive HABC 2.0 coupled with the ABC Clinical Program will have~     fewer symptoms at 12 months compared to those who receive the ABC Clinical Program only; and~     informal caregivers of patients who receive HABC 2.0 coupled with the ABC Clinical Program~     will have lower caregiver distress at 12 months compared to caregivers of patients who~     receive the ABC Clinical Program only.~      The secondary purpose of this study is to test whether combining HABC 2.0 with the ABC~     Clinical Program (1) reduces the number of emergency room and hospital visits for patients~     and their informal caregivers; (2) reduces the depressive symptoms and caregiver burden of~     informal caregivers; and (3) increases the caregiving self-efficacy of the informal~     caregivers.~      Hypothesis #2: Patients and caregivers who receive HABC 2.0 coupled with the ABC Clinical~     Program will have fewer emergency room and hospital visits at 12 months compared to these who~     receive the ABC Clinical Program only; and informal caregivers of patients who receive HABC~     2.0 coupled with the ABC Clinical Program will have fewer depressive symptoms, lower~     caregiver burden and higher caregiving self-efficacy at 12 months compared to caregivers of~     patients who receive the ABC Clinical Program only;.~   "
34174|NCT03119246|"~     Huntington's disease (HD) is an inherited neurodegenerative disease for which there are no~     existing disease-modifying treatments.~      Repair-HD is an EU FP7 consortium that aims to establish all the preclinical requirements for~     transplantation of stem cell-derived neurons in HD in order to replace those lost to the~     disease process. These requirements include the generation of new clinical assessments for~     detailed monitoring of patients with HD who have undergone cell replacement therapy.~      This protocol describes the beta testing of a new clinical assessment battery: Core~     Assessment Protocol for Intrastriatal Transplantation in HD version 2 (CAPIT-HD beta /~     CAPIT-HD2). CAPIT-HD beta represents a substantial revision of a previous CAPIT-HD battery~     published over 20 years ago, which is in need of updating in order to accommodate knowledge~     from clinical transplant studies over this time and to take advantage of technological~     advances in patient assessment.~      HD is a complex disorder in which there is relentless deterioration of motor, cognitive and~     behavioural functions, usually from mid-life onwards. The original CAPIT battery aimed to~     capture elements of change in all three domains, but was based predominantly on subjective~     semi-quantitative assessment tools that have poor inter-rater reliability. Moreover, a number~     of deficits, such as impairments in social cognition, were not recognised when the original~     CAPIT-HD battery was constructed, so we have developed novel assessments of these deficits,~     some of which are included in CAPIT-HD beta. The beta testing will take place in established~     HD clinical centres in Cardiff, Manchester, Paris, and Munster by teams of researchers who~     are experienced in leading clinic research in HD. Patients with early to moderate HD will be~     assessed at baseline, and at one and twelve months later, to assess the reliability and~     sensitivity of the CAPIT-HD beta battery. Arrangements for data storage and analysis are in~     place.~   "
34175|NCT03119233|"~     The study is to evaluate the safety and effectiveness of the PQ Bypass System to access,~     deliver guidewires and implant stent grafts for a percutaneous femoropopliteal (fem-pop)~     bypass.~   "
34176|NCT03119220|"~     The current study aims to counteract perceived stress-related barriers to implementation and~     maintenance of positive health behavior change (i.e., increasing physical activity), by~     providing an individually tailored and comprehensive informational support program. This~     translates into an intervention that, in addition to behavior monitoring (low informational~     support), will provide comprehensive informational support by combining advice and~     suggestions on how to achieve positive physical activity change with information on the~     health effects of such a change (high informational support). The latter will be achieved by~     providing information on general health benefits of increasing physical activity as well as~     on how physical activity change is linked to individual changes in health-relevant outcomes~     (i.e., mood and sleep quality changes). Specifically, it is hypothesized that:~        -  Higher chronic stress levels in general as well as stress perceived by the anticipated~          task of improving physical activity will be negatively associated with physical activity~          changes.~        -  Participants receiving informational support will show decreases in task-related stress.~        -  Furthermore, participants who receive comprehensive informational support will show~          larger physical activity improvements than participants who do not receive informational~          support.~        -  Initial stress will act as a moderator of the effects of informational support on~          physical activity, such that higher initial stress will reduce the positive effects of~          informational support.~      Importantly, the proposed intervention is specifically designed to support the subsequent~     development of an intervention program that is not only feasible, but easy to implement by~     individuals motivated to achieve a positive health behavior change. A key factor will be the~     insights gained into stress as a mechanism that counteracts implementation and maintenance of~     behavior change. This is especially important given the central role of stress in negative~     health outcomes associated with lack of physical activity, such as poor sleep, negative mood,~     and chronic low-grade inflammation.~   "
34177|NCT03119207|"~     Specific Aims:~        1. Quantify baseline patient room disruptions in the medical ICU during the proposed~          nocturnal Naptime .~             1. Obtain baseline light and noise levels in selected medical ICU study rooms.~             2. Obtain baseline activity level levels in selected medical ICU study rooms.~             3. Assess baseline information regarding nursing experience, prior training / beliefs~               regarding sleep promotion in the medical ICU~        2. Assess the feasibility of instituting a 4 hour (Midnight to 4:00 AM) nocturnal Naptime~          with minimization of patient interaction via tracking of differences in patient room~          activity, light and noise levels in control versus intervention patients.~           Secondary Aim~        3. Examine the associations between Naptime provision and patient sleep quality.~   "
34178|NCT03119194|"~     The purpose is to and to assess the mass balance recovery after a single oral dose of~     [14C]-BIA 9-1067 and to provide plasma, urine and faecal samples for metabolite profiling and~     structural identification.~   "
34179|NCT03119168|"~     This study is evaluating the effect of adding a high dose of simethicone to the standard~     polyethylene glycol preparation for screening colonoscopy in the quality of the preparation ,~     adenoma detection rate and withdrawal times.~   "
34181|NCT03119142|"~     The socioeconomic gradient in health is well known and is partially explained by differences~     in health-related behaviours across socioeconomic groups. There is reason to believe that the~     current economic crisis has been contributing to the observed rapid decrease in the adherence~     to the Mediterranean diet, thus reducing a protective factor against the development of major~     chronic diseases. This project aims at investigating whether the economic crisis could~     account for the shifting from the Mediterranean diet. Additionally, it will address~     variations in inflammation biomarkers (possibly dietary-related) or metabolic phenotypes as~     useful biological accounts for the decline in the adherence to Mediterranean diet. This~     project will also test whether for economically weakest people cultural resources could~     somehow attenuate the impact of material circumstances on lifestyle changes attributable to~     the economic crisis.~   "
34182|NCT03119129|"~     The purposes of this study are to complete the development of a video-enhanced, school-based~     drug prevention program for rural Hawaiian youth (Ho'ouna Pono) using community-based~     participatory research principles and practices, and to test the efficacy and adoption of the~     full intervention across all middle/intermediate schools on Hawai'i Island. These purposes~     will be accomplished through three specific aims. AIM 1 (Year 1) is to complete the Ho'ouna~     Pono drug prevention curriculum initially developed and validated in a NIDA-funded~     pilot/feasibility study (R34 DA031306). To date, five professionally filmed video vignettes~     depicting drug-related problem situations specific to rural Hawaiian youth and seven~     interactive classroom lessons have been created, implemented in randomly selected~     intervention schools, and preliminarily evaluated using a pre-test, post-test control group~     design. Aim 1 enhances and builds upon this work by producing two new video vignettes,~     re-editing a Behind the Scenes video, developing new classroom curricular components, and~     synthesizing the new content with the existing curriculum. AIM 2 (Years 2-3) is to evaluate~     the fully conceived curriculum across all middle/intermediate schools on Hawai'i Island (N =~     15) using a dynamic wait-listed control group design (Brown, Wyman, Guo, & Peña, 2006). Using~     this design, schools will be randomly assigned to four cohorts, and cohorts will be randomly~     assigned to receive the curriculum at designated times staggered across the two-year~     evaluation period. All participating youth will be measured at six designated time points~     across the two-year evaluation period. Because of the staggered implementation of the~     curriculum, intervention effects will differ by cohort, and earlier time points will include~     control schools for the initial cohorts receiving the intervention. All participating youth~     will receive pre-tests prior to curriculum implementation and post-tests upon curriculum~     completion, with youth attending schools in Cohorts 1-3 receiving follow-up evaluations. AIM~     3 (Year 4) is to assess community, systemic, and curricular factors related to the~     implementation, adoption, and sustainability of the curriculum within public~     middle/intermediate schools on Hawai'i Island.~      The present study is the result of seven consecutive years of NIDA-funded pre-prevention and~     translational pilot/feasibility drug prevention research focused on rural Hawaiian youth and~     communities. The overall outcome of this study will be an empirically supported, culturally~     grounded drug prevention curriculum relevant to Native Hawaiian and Pacific Islander youth.~     This study addresses the lack of prevention interventions for Native Hawaiians and other~     Pacific Islanders (NHOPIs) and indigenous youth populations, and directly contributes to the~     development of an indigenous prevention science (Okamoto, Helm, et al., 2014). It has~     implications for informing indigenous, Pacific Islander, and rural health disparities and~     health equity promotion.~   "
34183|NCT03119116|"~     Many people who suffer from irregular heartbeats (atrial fibrillation) which might cause~     stroke, need to take blood thinners to prevent it. It is important to prescribe the correct~     dose of blood thinners to the right patients to ensure the treatment works however avoiding~     complications. In the recent years, new blood thinners have been available; they require less~     laboratory tests and fewer visits to a doctor compared to older therapies. This study will~     look at how the general practitioners in the UK prescribe blood thinners according to the~     instructions given by the product manufacturer. We will use primary care data that is~     routinely collected by the general practitioners about their patients but without any~     possibility to identify individual patients. The results will help us to understand the~     magnitude of deviation from instructions in order to ensure that the patients benefit from~     the treatment.~   "
34184|NCT03119103|"~     Apnea, a cessation in breathing is critical condition that affects the person regardless of~     age.~      In infants, an apneic state occurs when there is an absence of respirations for 20 seconds~     (Alvaro & Rigatto, 2012). In adults, there is a correlation between sleep apnea with~     increased risks of cardiovascular health problems (Wimms, Woehrle, Ketheeswaran, Ramanan, &~     Armitstead, 2016; Wu, Yuan, Wang, Sun, Liu, and Wei, 2016; Hao, Xiandao, Li, Jingwu, Jinghua,~     & Yongxiang, 2016).~      The purpose of this proposed study is to investigate the reliability of a smart bed sheet's~     ability to detect physiological signals such as respiratory patterns.~      The study's goals are two-fold: 1) to determine the sensors' ability to detect patterns with~     regards to input signals, and 2) to evaluate the efficacy of pressure sensor signals~     collected in relaying respiratory rate and respiratory patterns to monitor different~     thresholds of respiration rate and pattern which may include critical parameters dangerously~     outside of life sustaining norms.~   "
34185|NCT03119090|"~     The goal of the Fontan Imaging Biomarkers (FIB) study is to identify the associations of~     blood and urine biomarkers to imaging parameters of ventricular mechanics.~   "
34186|NCT03119077|"~     This study will be conducted in a single center, double-blind with 6 dose escalation groups~     to evaluate the safety, tolerability, and pharmacokinetics of single ascending doses of~     BAY1161116.~   "
34187|NCT03119064|"~     New treatments are greatly needed for patients with recurrent glioblastoma. Metronomic~     temozolomide is a standard treatment option but has, at best, modest activity. The~     nanoliposomal irinotecan may be much more active than the parent compound irinotecan since~     nanoliposomal irinotecan's ability to cross the blood brain barrier is improved. This phase I~     study will establish the MTD of the combination of nanoliposomal irinotecan in combination~     with temozolomide safety and preliminary clinical efficacy of the combination of~     nanoliposomal irinotecan and metronomic temozolomide.~   "
34188|NCT03119051|"~     This study evaluates the effects of computerized cognitive training on different cognitive~     domains in mild cognitive impairment (MCI) patients. Patients will be randomized into the~     computerized training group and the control group in 1:1 ratio.~   "
34189|NCT03119038|"~     The purpose of this study is to clarify the efficacy of a multidrug versus single drug~     periarticular injection when only standard operative and postoperative pain management~     protocols used and the control group is exposed to what our investigators believe is the~     standard of care, single medication periarticular injection~   "
34190|NCT03119025|"~     Clearance of HCV infection requires early and multi-specific HLA class I restricted CD8+ T~     cell and class II restricted CD4+ T cell responses to both structural (Core) and~     non-structural HCV proteins (NS3, NS4A, NS5A, NS5B). Dendritic cells (DCs) are professional~     antigen-presenting cells that link innate and adaptive immune responses, and play a major~     role in priming, initiating, and sustaining strong anti-HCV T cell immune responses.~      The general objective of this study is to evaluate safety, feasibility and clinical efficacy~     of therapeutic vaccination in genotype 1 HCV patients using autologous DCs pulsed with~     recombinant HCV-antigens (Core and NS3). Expected effects: DC vaccination induces~     Core/NS3-specific immune response and reduces viral load in patients with chronic~     HCV-infection.~   "
34193|NCT03118986|"~     Chemotherapy-induced nausea and vomiting (CINV) are among the most bothersome symptoms during~     cancer treatment according to children and their parents. Most children receiving~     hematopoietic stem cell transplant (HSCT) conditioning experience CINV despite receiving~     antiemetic prophylaxis. Olanzapine improves CINV control in adult cancer patients, has a~     track record of safe use in children with psychiatric illness, does not interact with~     chemotherapy and is inexpensive. We hypothesize that the addition of olanzapine to standard~     antiemetics will improve chemotherapy-induced vomiting (CIV) control in children receiving~     high dose cyclophosphamide for hematopoietic stem cell transplantation (HSCT) conditioning.~   "
34194|NCT03118973|"~     Randomized, prospective study evaluating efficacy and safety of Goff transpancreatic~     septotomy vs. double wire technique for achieving biliary access in patients who fail initial~     cannulation at ERCP.~   "
34195|NCT03118960|"~     This non-randomized clinical study will compare pressure injuries and the change in pressure~     injuries for subjects who are placed on the Freedom Bed compared to those placed on a~     standard Group II Low Air Loss/Alternating Pressure Mattress in the Ventilator Unit at~     Northeast Center for Rehabilitation and Brain Injury. Additionally, the incidence of~     pneumonia, urinary tract infections, circulatory performance, sleep deprivation and caregiver~     self-perception on performance will be monitored and documented.~   "
34196|NCT03118947|"~     To evaluate the safety and tolerability of pimavanserin over 52 weeks of treatment in~     subjects with probable AD who have symptoms of agitation and aggression~   "
34197|NCT03118934|"~     The purpose of this study is to compare an alternative fitting guide to a current fitting~     guide for optimizing contact lens parameters and determining contact lens prescription.~   "
34198|NCT03118921|"~     Evaluation of the tolerance and acceptability of the virtual representation of its body~     image.~   "
34199|NCT03118908|"~     To evaluate effectiveness and safety of combined use of dietary supplements Amberen and Smart~     B by women with a typical (without complications) form of climacteric syndrome, with mild to~     moderate symptoms.~   "
34200|NCT03118895|"~     A study evaluating the safety and efficacy of the BioFreedom™ Biolimus A9™ coated Cobalt~     Chromium coronary stent system in patients at high risk of bleeding~   "
34201|NCT03118882|"~     The main study objective is to determine the feasibility and impact (effectiveness) of~     intervention models for lifestyle changing (diet and physical activity) on health outcomes.~     Women 50 to 54-year-old attending the local breast cancer screening and 58-year-old people~     (both sexes) undergoing colorectal cancer screening are invited to participate in the study.~     Compliers are randomized into 3 intervention groups (Diet, Physical Activity, and Physical~     Activity and Diet) and into the 'usual care' Control group. Biological sampling (blood and~     saliva) is collected from all participants. All participants undergo also anthropometric~     measurements and fill in a self-administered validated questionnaire on their dietary and~     physical activity habits. All enrolled subjects receive a booklet with basic information~     about diet and physical activity. Subjects randomized to the 3 intervention groups are also~     offered one theoretical and three training courses. The courses are specifically designed for~     the different interventions proposed and aimed at reinforcing the educational counseling and~     at supporting behavioral changes.~      Follow-up is performed at 8 (intermediate follow-up) and 12-14 (final follow-up) months for~     repeating anthropometric measurements and questionnaire filling and blood sampling (at the~     final one).~   "
34202|NCT03118869|"~     The b2-adrenoceptor (b2AR) mediates the physiological responses in the airway, which include~     bronchodilation, bronchoprotection. The b2-adrenoceptor (b2AR) mediates the physiological~     responses in the airway, which include bronchodilation, bronchoprotection, Enhanced~     mucociliary clearance.~      The b2AR gene is located on chromosome 5q31-q32, a region that is genetically linked to~     asthma and related phenotypes. There are three best known polymorphisms in the coding region~     of the b2AR gene that can modulate the function of the receptor.~   "
34203|NCT03118856|"~     To assess the accuracy of predicting histology of colorectal polyps with electronic~     chromoendoscopy.~   "
34204|NCT03118843|"~     The primary objectives of this study are to determine the efficacy of treatment with~     sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks~     as measured by the proportion of participants with sustained viral response 12 weeks after~     cessation of treatment (SVR12) and to evaluate the safety and tolerability of treatment with~     SOF/VEL/VOX FDC.~   "
34205|NCT03118830|"~     Patients will be divided into two groups Group A; patients using long protocol and freeze all~     embryos Group B; patients using antagonist protocol with fresh embryo transfer Patients will~     be carefully chosen according to a strict inclusion and exclusion criteria after meticulous~     revision of patient files.~      In the long protocol, daily SC injection of Triptorelin :Decapeptyl 0.1 mg (Ferring,~     Switzerland) 0.1 mg started at day 21 of the cycle prior to stimulation cycle and continued~     till the day of hCG triggering. Gn stimulation started after fulfilling stimulation start~     criteria of thin endometrium < 5 mm and low E2 < 50 and LH < 5IU/l with either HMG(Menogon;~     Ferring, Switzerland) or rFSH (Gonal-f; Merck Serono, Germany) in a starting dose of 150-300~     IU/day according to women age, day 3 FSH,AMH and previous gonadotropin response then~     adjustment of the dose according to ovarian response monitored by serum E2 and ultrasound~     evaluation. All patients were followed up by Transvaginal ultrasound scan daily or on~     alternate days according to the ovarian response to treatment starting on treatment cycle day~     (6) for folliculometry and endometrial thickness and pattern.~      Triggering by HCG 10000 IU IM (Pregnyl, Organon, the Netherlands) when 2 or more follicles~     have 18 mm as a mean diameter .~      Flexible GnRH antagonist protocol was done with daily s.c administration of cetrorelix 0.25~     mg (Cetrotide, Merck Serono, Darmstadt, Germany) started when one or more of the following~     criteria were achieved: (i) one or more follicle reached 14 mm diameter; (ii) The level of~     serum E2 reached 600 pg/ml; and (iii) The level of serum LH levels reached 10 IU/l . Daily sc~     rFSH (Gonal-f; Merck Serono , Darmstadt, Germany) injections was started on 2nd day of the~     cycle in the antagonist protocol. Continuation of rFSH and GnRH antagonist daily until~     triggering day was done.~   "
34206|NCT03118817|"~     This study evaluates the anti-tumor efficacy and safety of single agent HM95573 administered~     in patients with solid tumors harboring mutations in either BRAF, KRAS or NRAS gene.~   "
34207|NCT03118804|"~     To evaluate whether EELI, RVD, GI were good predictor for weaning from mechanical ventilation~   "
34208|NCT03118791|"~     Anthocyanins are a subclass of (poly)phenols very abundant in berries and red grapes.~     Increasing evidence from human epidemiological and dietary intervention studies suggests that~     anthocyanins may have cardiovascular health benefits. The present study aimes to investigate~     whether pure anthocyanin consumption improves endothelial function in healthy individuals and~     if these effects are dose-dependent.~   "
34209|NCT03118778|"~     This is a descriptive retrospective database analysis study in using database. All patients~     with a physician PPI prescription will be selected to estimate the PPI inappropriate use.~   "
34211|NCT03118752|"~     The investigators will complete a pragmatic randomized trial (N=260) of the 26-week blended~     collaborative care (CC) intervention compared to enhanced usual care (eUC) in patients~     admitted for acute coronary syndrome (ACS) or heart failure (HF) found to have current~     depression, generalized anxiety disorder (GAD), or panic disorder (PD). The CC intervention~     will use a novel three-pronged approach to these high-risk patients. Care managers will~     provide centralized care coordination and specific interventions targeting: (1) the~     psychiatric disorders, (2) cardiac health behaviors, and (3) the cardiac illness. The primary~     study outcome will be physical function at 26 weeks, measured by the Duke Activity Status~     Index (DASI), given links between function and new cardiac events. The investigators will~     also examine effects on numerous other outcomes important to patients and healthcare systems.~      Specific Aim 1 [patient-centered outcomes—primary aim]: To compare between-group differences~     in the CC and eUC conditions on improvements in physical function, health-related quality of~     life, mental health, patient satisfaction, and other key patient-reported outcomes at 26 and~     52 weeks.~      Specific Aim 2 [adherence and medical outcomes]: To compare between-group differences on~     health behaviors (physical activity, diet, smoking, medication adherence) and major adverse~     cardiac events.~      Specific Aim 3 [cost]: To compare healthcare costs between groups and assess the~     cost-effectiveness of CC.~      Hypotheses: The investigators expect this bolstered CC program to be associated with superior~     improvements in physical function, health-related quality of life, patient satisfaction, and~     adherence at 26 weeks, with promising effects on major adverse cardiac events. The~     investigators likewise expect the intervention to be cost-effective~     (<$10,000/quality-adjusted life year) over the study period.~   "
34212|NCT03118739|"~     The purpose of this clinical research study is to evaluate signals of potential clinical~     benefit of the combination of RDEA3170 and Febuxostat in lowering concentrations of~     circulating uric acid and thus improving kidney or cardiovascular status of patients with~     hyperuricemia, albuminuria, and Type 2 diabetes (T2DM)~   "
34213|NCT03118726|"~     This study will engage hospitals working with the New Mexico Perinatal Collaborative (NMPC)~     on implementing immediate postpartum long-acting reversible contraception programs. All~     hospitals in New Mexico interested in implementing immediate postpartum LARC programs will be~     eligible to participate in the NPMC program evaluation. The study will evaluate the~     components of this implementation program at several New Mexico hospitals using a stepped~     wedge design,with components being introduced to each hospital one at a time~   "
34214|NCT03118713|"~     The primary purpose of this study is to assess the renal protective effect of ipragliflozin~     in combination with metformin on the percent change of UACR from baseline to 24 weeks against~     glimepiride in combination with metformin in type 2 diabetes mellitus patients with~     albuminuria. The secondary purpose of this study is to assess the efficacy, safety and impact~     on quality of life (QoL) of ipragliflozin in combination with metformin against glimepiride~     in combination with metformin in type 2 diabetes mellitus patients with albuminuria.~   "
34215|NCT03118700|"~     The purpose of this study is to examine the acute effect of continuous and aerobic interval~     exercise on postexercise central BP response in men with an elevated blood pressure.~   "
34216|NCT03118687|"~     The Human Immunome Program is a large-scale, open-source effort seeking to fill a major gap~     in our knowledge of the immune system. The power of the immune system to fight disease lies~     in its ability recognize and adapt to an astonishing range of threats from viruses, parasites~     and bacteria to cancer cells. Underlying this ability is a vast but specific set of genes and~     molecular structures known as the human immunome, or the parts list of the immune system.~     This study aims to decipher the genetic sequences that make up this part list and link it to~     information about a person's microbiome composition and characteristics such as health~     history, race, and demographics over time. This information, made freely available to the~     public for use in research in de-identified form, will allow investigators to answer a wide~     variety of different questions about immune system function. This could transform how we~     diagnose, prevent and treat disease though the identification of new biomarkers while~     enabling highly targeted, computationally designed vaccines and therapies that reduce time~     and risk of product development.~   "
34217|NCT03118674|"~     In the medical literature there case reports that Harvoni improves symptoms in patients with~     PCT. However, this has never been systematically tested. Therefore, the purpose of this study~     is to assess whether Harvoni alone is an effective therapy of active PCT in patients with~     Chronic Hepatitis C.~   "
34218|NCT03118661|"~     The goal of this proposal is to determine the effect of maraviroc when it has been a part of~     the antiretroviral (ART) regimen given immediately after allogeneic hematopoietic cell~     transplant (allo-HCT) for HIV-1 infected participants who have a hematopoietic malignancy or~     other underlying disorder requiring an allogeneic transplant. Maraviroc has been given in~     practice to alleviate symptoms of graft vs. host disease (GvHD). Given its mechanism of~     action, it may also have an effect on the reservoir size of HIV-1 in infected patients. This~     study will inform potential future studies, evaluating the effect of this approach on the~     incidence and severity of GvHD, and determining its effect on HIV-1 reservoir.~   "
34219|NCT03118648|"~     The aim is to reduct spontaneous use an activities of daily living of the paretic upper limb~     after stroke i six months after patient discharge from rehabilitation center. The level of~     functional recovery at rehabilitation discharge could better guide rehabilitation strategies~     to enhance independence and participation in daily life.~      This study aims to determine, in patients after stroke, the optimal affected upper limb~     recovery threshold at rehabilitation discharge to predict spontaneous level of use of~     affected upper limb in activities of daily living, six month later.~      This study is a multicentric prognostic prospective cohort study. The main prognostic~     variable will be the Action Arm Test (ARAT, Lyle, 1981) score at rehabilitation discharge and~     the predicted variable will be the Motor Activity Log - 28 (Taub et al. 1993) score at 6~     months post discharge.~   "
34234|NCT03118453|"~     Implementation of a behavioral medicine approach in physical therapy for patients with~     persistent musculoskeletal pain is in accordance with the state of science. Translation of~     research into clinical PT practice is challenging and may demand active implementation~     strategies.~      The aim is to evaluate the implementation of a behavioural medicine approach for patients~     with persistent musculoskeletal pain concerning sustainable health benefits and sick-leave,~     as well as the cost-effectiveness of the implemented treatment.~      Treatment outcomes for patients from two groups of physical therapists in primary care will~     be compared. In one group active implementation strategies have been employed, and in the~     other (control) passive implementation strategies during a 6-months intervention period.~     Patients are recruited during one-year after the implementation period.~      The short and long-term effects of the implementation of the BM approach in PT treatment on~     patients' sick-leave, activity and participation, and health related quality of life will be~     compared to the patients from control condition clinics. The cost-effect and cost-benefit of~     an implementation of a behavioral medicine approach in physical therapy is evaluated from the~     perspective of the health care organization and society.~   "
34220|NCT03118635|"~     Convergent findings from several studies document that children, especially those who are~     already overweight or obese or from racial / ethnic minority groups, are at risk for~     accelerated weight gain during the summer months. Therefore, this project is comprised of~     three separate community-based interventions designed to increase access to healthy meals and~     physical activity opportunities to minimize excess summer weight gain in elementary school~     children from a diverse, low-income Rhode Island community. Specifically, we will complete a~     quasi-experimental study in which we will design and deliver a physical activity intervention~     in conjunction with the Summer Food Service Program (SFSP) to 50 children living in a~     low-income, urban community. We anticipate that the addition of physical activity programming~     to the SFSP, a federal program funded by the USDA which reimburses states for serving lunch~     meals to children during the summer in communities where at least 50% of students are~     eligible for free or reduced-price school meals, will increase both the acceptability and~     effectiveness of the SFSP and affect 1) physical activity levels, 2) sedentary behavior, and~     3) diet quality. The primary outcome (change in BMI z-score) will be compared between the 50~     kids enrolled in the active intervention and 50 children enrolled in the control condition,~     both recruited from the same community.~   "
34221|NCT03118622|"~     Comparison of Intubation using Pentax (Pentas AWS, Pentax, Tokyo, Japan) and Macintoch in~     pediatric patients~   "
34222|NCT03118609|"~     The Understanding Needs Project is designed to gain an understanding of the needs of~     informal caregivers. Researchers have designed a survey to highlight activities of daily~     living involved in the caregiving role, pain related to caregiver, and potential services~     desired. The initial phase of the study will consist of a focus group of informal caregivers~     to discuss current needs. The survey will then be refined based on knowledge gained from the~     focus group, and feedback from expert researchers. The refined survey will then be~     disseminated to caregivers throughout the country.~      Please click on the following anonymous link to participate:~     https://chhscolostate.co1.qualtrics.com/jfe/form/SV_54j83BQSItMuoUB~   "
34223|NCT03118596|"~     The study aims to establish which of the two second generation Supraglottic Airway Devices,~     the I-gel or the the laryngeal ask airway (LMA) Protector, is best suited to be used as a~     conduit to fibreoptic bronchoscope assisted tracheal intubation. The primary outcome of this~     will be the time to complete the tracheal intubation.~   "
34224|NCT03118583|"~     The goal of this study is to assess the effects of a dietary supplement on fasting~     lipoprotein lipids and a marker of inflammation in men and women with levels of low-density~     lipoprotein cholesterol above desirable levels.~   "
34225|NCT03118570|"~     The purpose of this study is to select a suitable dose of BPS804 by comparing it with a dummy~     treatment and measuring the strength/quality of bone using a special type of CT scanner.~     Participants will be treated for 1 year.~   "
34226|NCT03118557|"~     Does a twice weekly, 12-week Pilates pelvic floor strengthening program improve short- and~     long-term measures of stress urinary incontinence symptoms in women ages 45-70 years of age?~   "
34227|NCT03118544|"~     The is an observational, prospective study to evaluate the effect of the DyeVert System on~     contrast volume administration in patients undergoing clinically-indicated chronic total~     occlusion (CTO) percutaneous coronary intervention (PCI)~   "
34228|NCT03118531|"~     To evaluate the clinical safety and efficacy in Chinese subjects, eligible for percutaneous~     transluminal coronary angioplasty (PTCA) in lesions amenable to treatment with a 34/38 mm~     Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System.~   "
34229|NCT03118518|"~     To provide data demonstrating the safety and effectiveness of the Arctic Front Advance™~     Cardiac CryoAblation Catheter for the treatment of recurrent symptomatic paroxysmal atrial~     fibrillation, without the requirement that the subjects be drug refractory.~   "
34230|NCT03118505|"~     The purpose of this study is to obtain safety and effectiveness data on the investigational~     device for multi-level PLF procedures and determine the most appropriate rhBMP-2 dose for use~     in this indication. The study information may be used for a potential pivotal study design.~   "
34231|NCT03118492|"~     This pilot clinical trial studies the side effects of combination chemotherapy, total body~     irradiation, and donor blood stem cell transplant in treating patients with secondary~     myelofibrosis. Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors.~     Giving combination chemotherapy and total body irradiation before a donor blood stem cell~     transplant helps to stop the growth of cells in the bone marrow, including normal~     blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor~     are infused into the patient they may help the patient's bone marrow make stem cells, red~     blood cells, white blood cells, and platelets.~   "
34232|NCT03118479|"~     The investigators are doing this research study to look at the relationship between~     testosterone (the main sex hormone in men) and insulin (the hormone that controls blood sugar~     levels) in men with Idiopathic Hypogonadotropic Hypogonadism (IHH).~      The investigators hypothesize that normalizing testosterone levels in men with IHH enhances~     insulin sensitivity, reduces visceral fat, increases lean body mass, and improves the lipid~     profile.~   "
34233|NCT03118466|"~     This research study is evaluating how a drug called lenalidomide, given in combination with~     the standard chemotherapy regimen of Mitoxantrone, Etoposide, and Cytarabine, commonly~     referred to as MEC, works in individuals with either relapsed or refractory AML~   "
34235|NCT03118440|"~     This study is intended to compare the feasibility, safety and efficacy of Ensite-NavX~     zero-fluoroscopic navigation system to conventional fluoroscopic X-ray approach as to~     performing single-chamber pacemaker implantation.~   "
34236|NCT03118427|"~     This study is intended to compare the feasibility, safety and efficacy of Ensite-NavX~     zero-fluoroscopic navigation system to conventional fluoroscopic X-ray approach as to~     performing double-chamber pacemaker implantation.~   "
34367|NCT03116724|"~     Total of 89 patients undergoing elective cardiac surgery will be enrolled.~      Right CVC insertion begins at their intersection of the cricoid cartilage level and the~     triangular point where the sternal head of the SCM muscle meets the clavicular head. After~     insertion the central venous catheter through the right internal jugular vein and positioning~     it, the location of the tip of the central venous catheter will be confirmed by TEE.~   "
34237|NCT03118414|"~     The objectives of this study were to 1) compare balance of the elderly by Berg Balance Scale~     (BBS) and Timed Up and Go Test (TUG) among physical exercise, virtual reality, brain exercise~     and control groups after intervention, 2) compare cognitive function of the elderly by using~     Timed Up and Go Cognitive (TUGC) and Montreal Cognitive Assessment (MoCA) among physical~     exercise, virtual reality, brain exercise and control groups after intervention, 3) compare~     muscle strength of elderly by 5 Times Sit-To-Stand Test (5TSTST) and Hand Grip Strength (HG)~     among physical exercise, virtual reality, brain exercise and control groups after~     intervention, 4) compare fear of falling by using Fall Efficacy Scale-International (FES-I)~     among physical exercise, virtual reality, brain exercise and control groups after~     intervention, 5)investigate the perspective of exercise among physical exercise, virtual~     reality, brain exercise and control groups after intervention.~   "
34238|NCT03118401|"~     As they age, the intestinal elimination function can be altered by external factors. Sleeping~     is also a vital need for maintaining health. Sleep time varies with age (from 18h / day for~     an infant to 7h30 on average for an adult) and sleep disorders increase with age (INSERM~     source). In our study, the night is from 9 pm to 7 am, corresponding to the working hours of~     the night shift. Between 42% and 50% of episodes of wakefulness of more than 4 minutes in~     EHPAD are due to noise, light or the practice of care related to incontinence. 87% of all~     incontinence care practices have been associated with wake-up episodes. A personalized day~     care program would allow residents to improve the quality of their sleep by minimizing stools~     at night and therefore interventions by caregivers.~      The ritual of stools, can be defined as the set of rules to observe to defecate in good~     physiological, physical conditions:~        -  Be in a suitable place for intestinal elimination: personal bathroom preferably on the~          toilet or on a pierced chair that will perhaps be more secure and comfortable with the~          armrests. The position to be taken is important.~        -  Propose a small bench to put under the feet to raise the knees higher than the hips and~          increase the abdominal pressure.~        -  Preserve the visual and auditory intimacy of the resident at the time of defecation.~          Failure to do so may result in the person repressing his desire to defecate.~        -  Allow the resident the time needed on the toilets the doorbell at hand and with the~          assurance that the caregiver will come back in a short time. Do not press it and do not~          forget it, privilege the autonomy and check that there is toilet paper.~      The establishment of the stool ritual is not intended to reduce the amount of stool by day,~     but it aims to postpone the nighttime exemption on the day, and does not prevent the stool~     emission to other times of the day or night.~   "
34239|NCT03118388|"~     This randomized controlled trial (RCT) compared the efficacy between the Social Enterprise~     Intervention (SEI) and Individual Placement and Support (IPS) with homeless youth with mental~     illness.~      Methods: Non-probability quota sampling sampling was used to recruit 72 homeless youth from~     one agency, who were randomized to the SEI (n=36) or IPS (n=36) conditions.~   "
34240|NCT03118375|"~     The purpose of this study is to assess the benefit of new super-power bone-anchored hearing~     aid (BAHA) processors in BAHA users. BAHAs are able to help people with mixed/conductive and~     single-sided hearing loss when they are unable to use or receive limited benefit from~     traditional hearing. Until recently, BAHAs were only recommended to people with up to a~     moderate hearing loss. New super-power BAHA processors may be able to help people who~     previously were not candidates for BAHAs or received limited benefit from them. The~     information collected in this study may lead to improved evaluation of and expanded treatment~     options for people considering BAHA. Different types of hearing tests will be used to compare~     the devices.~   "
34241|NCT03118362|"~     Balanced solutions with low chloride concentration could represent an alternative to high~     chloride concentration solutions. Such balanced solutions contain other acid as buffers (i.e.~     acetate and/or gluconate). However, acetate has been associated with alteration of cardiac~     function when used as buffer in dialysate when high acetate concentrations are used and could~     promote the development of metabolic acidosis if it accumulates. Therefore, the safety of~     such solutions remains poorly explored. Because critically ill patients receive large amount~     of fluid during the early phase of resuscitation, large amount of acetate are to be~     administrated if such solutions are used. While acetate-containing solutions have been~     suggested to be safe in this setting, studies are still lacking regarding clearance and~     accumulation in critically ill patients.~      It is expected to include 28 patients, the objective to analyze the data of 20 patients.~   "
34242|NCT03118349|"~     Open label, nonrandomized, dose-escalation with cohort expansion trial of MVT-5873/MVT-1075~     in subjects with previously treated, CA19-9 positive malignancies (e.g., pancreatic~     adenocarcinoma).~   "
34243|NCT03118336|"~     There is substantial evidence supporting the fact that ectopic fat accumulation is an~     important contributor to type 2 diabetes complications and cardiovascular risk [1].~     Epicardial adipose tissue (EAT), located between the myocardium and the visceral layer of the~     pericardium has been associated with atrial fibrillation and with coronary artery disease [2,~     3] and its abundance predicts the number of cardiac events within 8 years [4]. In addition,~     myocardial steatosis has been shown to be an independent predictor of diastolic dysfunction~     [5] [6]. Furthermore, in type 2 diabetic patients, bariatric surgery can reduce cardiac~     ectopic fat accumulation and improve cardiac function [7] [8]. When added to standard care,~     10 or 25 mg/d of empagliflozin, an inhibitor of sodium-glucose cotransporter 2 (iSGLT2),~     significantly reduces the risk of death, cardiovascular death, and hospitalisation for heart~     failure among individuals with type 2 diabetes and established cardiovascular disease when~     compared to placebo [9]. The mechanisms of empagliflozin-improved cardiovascular outcomes in~     type 2 diabetic patients at high risk of cardiovascular events are not known. We hypotheses~     that empaglifozin could modulate cardiac ectopic fat and cardiac metabolism in obese type 2~     diabetic patients.~   "
34244|NCT03118323|"~     The aim of the present study is to determine the monetary value of endodontic treatment~     (primary root canal treatment) compared to the alternative treatment options, such as~     extraction with or without subsequent insertion of a dental implant or placement of a fixed~     dental prosthesis.~   "
34245|NCT03118310|"~     The impact of popular diets on liver-related health is unclear. In this randomized,~     controlled trial, patients with NAFLD will be randomized to one of two popular diets or a~     placebo diet.~   "
34257|NCT03118154|"~     This study will compare subjects with a history of pelvic or menstrual pain diagnosed with~     endometriosis treated at Clear Passage with untreated control subjects. The treatment group~     will be a retrospective chart review; the control subject group will be a prospective~     questionnaire based study.~      The study will assess the changes in pain experienced by subjects treated with manual therapy~     at Clear Passage to untreated subjects with endometriosis.~   "
34368|NCT03116711|"~     The purpose of this study is to determine the effects of diet type selection based on~     response to a Carbohydrate Intolerance Questionnaire (CIQ) and genetic screening on success~     to a weight loss and exercise program.~   "
34246|NCT03118297|"~     The subdermal etonogestrel (ENG) implant, a long-acting reversible contraceptive (LARC)~     method, is among the most effective forms of reversible contraception and thus, an important~     tool in the quest to reduce unintended pregnancy. However, despite overall increases in LARC~     use in the United States from 1.5% in 2002 to 7.2% in 2011, and 11.6% most recently in 2015,~     implant use continues to make up a small proportion of LARC use. While evidence to explain~     this low uptake of implants is lacking, one potential reason is patient and provider concerns~     about unpredictable bleeding.~      As a result of this, many studies have been performed in attempts to discover therapies for~     unscheduled bleeding in progestin-only contraceptive users. Some of these studies include~     those investigating selective progesterone receptor modulators, such as mifepristone and~     ulipristal acetate (UPA), which did find some benefit. Although a previous study showed mixed~     benefit, the investigators feel that this medication has demonstrated both biologic~     plausibility as well as clinically important outcomes. This previous study may not be~     entirely translatable to the proposed research as therapies were used for different~     indications (prophylaxis vs. treatment) and different progestins and delivery systems were~     studied. Therefore, the investigators believe UPA should not be discounted as a potential~     therapy. UPA may provide an additional safe and effective option for treatment of irregular~     bleeding with implants in women. In addition, UPA is currently available in outpatient~     pharmacies in the U.S. as a single 30mg oral tablet.~      The investigators propose to investigate UPA for the treatment of unscheduled and troublesome~     bleeding in ENG implant users.~   "
34247|NCT03118284|"~     Urinary [Foley] catheters [tubes] are commonly placed in patients undergoing surgery;~     approximately 25% of surgical patients will receive one. Among patients who receive urinary~     catheters, discomfort associated with the Foley catheter is common; between 47-90% of~     patients experience catheter related bladder discomfort [CRBD]. Presence of a foreign object~     in the bladder even for short periods of time may result in symptoms such as a burning~     sensation, pain in the lower abdomen, muscle spasms and a sense of urgency to urinate. There~     is some evidence that suggests that hospital-acquired urinary tract infections are directly~     related to catheter placement, which causes mechanical damage and local inflammation to the~     urethra and the bladder. Based on research conducted on a similar mechanism where an airway~     tube is inserted into a patients throat for delivery of general anesthesia - we hypothesize~     that CRBD is related to injury and inflammation caused by the catheter placement and that~     this occurs in a sterile environment.~   "
34248|NCT03118271|"~     To compare the effect of lumbar traction, lumbar spinal manipulation and lumbar surgery in~     the treatment of LDH.~   "
34249|NCT03118258|"~     Every year, in France, 3 000 women are diagnosed for cervical cancer, and 1 000 die each~     year. The incidence of this cancer is very inequal: recent studies found regional, social and~     economical inequalities.~      Currently, in France, the pap-smear test is the reference in prevention for cervical~     neoplasia (CIN) and cancer screening. Screening and treatment allowed to reduce the incidence~     and the mortality by cervical cancer by half, since the two last decades. But many women are~     still not reached by prevention programs, especially precarious women. In 2013, Doctors of~     the World France evaluated that almost 70% of women aged from 25 to 65 years coming in its~     medical center had never benefit of a pap-smear test.~      The objective of this study is to compare the rate of participation in the pap-smear~     screening with the proposition of a prevention consultation about sexual and reproductive~     health associated or not with the proposition of a vaginal Human Papillomavirus (HPV)~     self-sampling.~   "
34250|NCT03118245|"~     Children aged below 7 years are randomly assigned to AuraGain Group or I-gel group. After~     anesthetic induction, AuraGain or I-gel is inserted and mechanical ventilation is started.~     Oropharyngeal leak pressure, peak inspiratory pressure, success rate for insertion, ease for~     insertion, ease for gastric tube insertion and fiberoptic bronchoscopic views will be~     compared between two groups.~   "
34251|NCT03118232|"~     This is a cluster-randomized trial of nursing homes to assess whether decolonization with~     routine chlorhexidine bathing and periodic use of nasal antiseptics can reduce~     hospitalizations associated with infections, antibiotic utilization, and multi-drug resistant~     organism (MDRO) prevalence. The comparator arm will be routine bathing care.~   "
34252|NCT03118219|"~     Involuntary childlessness is experienced as emotionally stressful, however psychosocial~     counseling is not always available on the spot. Aim of this RCT study is to examine the~     efficacy and acceptance of a psychological low-dose online intervention for couples in~     reproductive treatment.~   "
34253|NCT03118206|"~     To compare the effect of lumbar spinal manipulation, physical therapy and surgical management~     in the treatment of lumbar spinal stenosis.~   "
34254|NCT03118193|"~     According to the WHO, major depressive disorders have become the second worldwide cause of~     disability. Treatment, long-term medication, leads to frequent resistance (up to 40%).~      Establishing a cerebral molecular signature of depression is not feasible in humans (need for~     cerebral samples). The alternative is to use peripheral biological samples (blood, urine,~     saliva).~      Metabolomic is the integrated and quantitative study of all the metabolites of a biological~     system. This aims to define the metabolic status of an organism for a particular condition.~      Metabolites are derived from biological extracts (cells, tissues, serum, plasma, urine, etc.)~     and are detected by:~        -  liquid or gas chromatography coupled to mass spectrometry (LC-MS, GC-MS),~        -  proton nuclear magnetic resonance (1 H-NMR). The biomarkers resulting from these studies~          have become important diagnostic criteria, measured objectively and evaluated as~          indicators of a normal or pathological state, or even predictors of treatment efficacy.~      This approach allows the discovery of biomarkers that best describe the status of a disease~     for better understanding and are usable in a context of individualized medicine, with effects~     on clinical practice and management.~   "
34255|NCT03118180|"~     A prospective study to evaluate the safety and efficacy of CART19 for refractory/relapsed B~     cell lymphoma.~   "
34256|NCT03118167|"~     A double-blind randomized controlled trial (RCT) was conducted in current human study. This~     study aims to investigate the intervention effect of AOB-w on the short-term exposure and~     toxicokinetics of acrylamide, a dietary hazardous substance generated during heat processing,~     in Chinese adolescents.~   "
34369|NCT03116698|"~     Once or twice daily 12 week treatment in patients with Actinic Keratosis randomized to~     treatment in one of four arms.~   "
34370|NCT03116685|"~     This study will evaluate the efficacy and safety of OC5 in patients with PH.~   "
34258|NCT03118141|"~     The purpose of this randomized clinical trial is to compare the efficacy and safety with~     transfer of embryos selected by next generation sequencing (NGS) versus conventional~     morphological criteria. Subjects with 3 or more blastocysts on day 5 of embryo culture will~     be randomized to the PGS or IVF group. A Freeze-all strategy and a single frozen blastocyst~     transfer will be performed in both PGS and IVF groups. The primary outcome is the cumulative~     live birth after transfers of up to 3 single blastocycsts in both groups.~   "
34259|NCT03118128|"~     Metformin's Antitumor activity were identified from differens diabetic patients trials,~     mainly associated to its mechanism of action and protein - kinase AMPK (AMP-activated protein~     kinase) activation. According to Cancer and Diabetes International Consensus from 2012,~     diabetes increases the risk for developping cancer and metformin has an protector effect~     against cancer cells and has an impact on overall survival.~      Chemotherapy drug resistance induces treatment fail in oncology. Metformin increases AMPK~     levels, blocks PI3K (phosphatidylinositol 3- kinase)/ AKT /mTOR(mammailian Target of~     Rapamycin) pathway but few evidence associated with drug resistance gene expression.~      This is an, experimental one-center study that pretends to stablish the effect of adding~     metformin 850 mg PO three times a day over the multi-drug resistance gene expression (ABCB1)~     in de novo Acute Lymphoblastic Leukemia in one 7-days cycle with prednisone as pre-treatment-~     and on the induction remission treatment.~   "
34260|NCT03118115|"~     MONITRANS project consist of developing a monitoring technology of post-operative breast~     reconstruction by detecting thrombosis. Its aim is to reducing time spent in hospital by~     monitoring patients at home.~      Thrombosis following to abdominal free flap harvesting for breast reconstruction is a rare~     phenomenon (with a 2 until 15 % frequency). Moreover, it leads to ischemia by limiting water~     intake in the plasma compartments. The investigator would like to prove, by this research~     project, that they are able to detect ischemia via bioimpedance technology.~      During abdominal free flap harvesting for breast reconstruction, there are few minutes where~     the flap is clamped because of anastomosis on the recipient vessels. The investigators would~     seize the opportunity of this step, which is similar to vascular thrombosis, to measure~     bioimpedance variations.~      Therefore they would like to measure variations of the flap bioimpedance before and after~     vascular section. Another purpose consists of developing an algorithm which will detect~     postoperative thrombosis.~   "
34261|NCT03118102|"~     The investigators aim to investigate the effect of operating room noise on anesthetist~     hearing~   "
34262|NCT03118089|"~     The health risks and costs associated with malnutrition can be significantly reduced if~     symptoms are recognized early and treated effectively. Oral nutritional supplements (ONS)~     have been shown to increase nutrient intakes and maintain or improve nutritional status and~     functional outcomes in patients in a variety of settings. However despite this it is~     frequently reported that compliance to ONS, which are often milk based drinks, is poor. The~     aim of the present study is to assess the effectiveness of a new biscuit style nutritional~     supplement in the management of malnutrition.~      The study is a randomized controlled eight-week intervention study. Suitable participants~     currently being prescribed ONS and who meet the study inclusion and exclusion criteria, will~     be identified by either staff in care facilities, Registered Dietitians or by General~     Practitioner (GP) surgeries. Participants (n=80) will be stratified based on BMI and gender~     and randomly assigned to either the biscuit ONS group (n=40) or to remain on their existing~     ONS prescribed as part of their standard care practice (n=40). Changes in anthropometry,~     functional status, nutritional intake and appetite, general health, gastrointestinal symptoms~     and biochemistry (correction of nutritional deficiency), as well as compliance and~     acceptability of ONS will be assessed between week 0 and week 8. Participants will also be~     visited mid-intervention (week 4) to ensure well-being and assess compliance.~      This work is funded by Calerrific Ltd. and seeks to determine if the new biscuit style~     nutritional supplement could be used as an alternative to, or in conjunction with, existing~     ONS to improve compliance and aid the recovery of malnourished patients.~   "
34263|NCT03118076|"~     Peripheral nerve block has been recommended as the technique for postoperative pain~     management because it provides equivalent analgesia but with fewer adverse effects than~     either systemic or epidural analgesia.~      The use of clonidine, a partial α2 adrenoceptor agonist, has been reported to prolong the~     duration and analgesia in peripheral nerve blockade. Dexmedetomidine is a more selective and~     shorter-acting α2 adrenergic receptor.However, its use in femoral and common peroneal nerve~     blocks has not been described.~      In this study, we investigated the effect of adding dexmedetomidine as additive in femoral~     and common peroneal nerve blocks for postoperative analgesia.~      Patients, diagnosed as oromaxillofacial tumor and undergoing elective free fibular or~     anterolateral thigh flap reconstruction, were divided into two groups in a randomized,~     double-blind fashion. In Group Ropivacaine (Group R), nerve blocks were administered with~     0.3% ropivacaine. In Group Ropivacaine + Dexmedetomidine (Group RD), nerve blocks were~     administered with 0.3% ropivacaine and 50 μg dexmedetomidine.The primary endpoints were the~     onset time and duration of sensory blocks. The secondary endpoints were heart rate, blood~     pressure, SpO2, sedation level, the duration of motor blocks.~   "
34275|NCT03117920|"~     MinPAC aims to see if the drug Minnelide can slow down tumour growth in patients with~     pancreatic cancer that is not responding to treatment. Minnelide is designed to rapidly~     release the anti-tumour molecule triptolide in the bloodstream and has been shown to slow~     cancer cell growth and induce cancer cell death. Minnelide is currently being investigated in~     other early phase trials and has shown promising response data.~      There are strict eligibility criteria for this trial. Broadly speaking, patients with~     pancreatic cancer that has spread to other organs and has progressed on one or more~     chemotherapy regimens are eligible. Participants will receive Minnelide on days 1-21 of each~     28 day cycle until their cancer stops responding to treatment. After that participants will~     be followed up 3 monthly for the collection of disease status and survival data.~      MinPAC includes biological and imaging studies. Participants will be asked to donate tumour~     and blood samples and will be asked to undergo additional PET Scans. The study is being~     carried out in 4 sites in the UK and USA.~   "
34371|NCT03116672|"~     Aim. To compare the outcome of preoperative administration of single-dose ketorolac,~     non-steroidal anti-inflammatory drug and placebo on postoperative pain in teeth with~     irreversible pulpitis and apical periodontitis.~   "
34264|NCT03118063|"~     Contextualization: Trigger points are muscle nodules found in muscles. We can observe five~     different types of trigger point, in clinical practice two of them stand out, the active~     trigger point; Which is painful; And latent; Asymptomatic; Both of which are sensitive to~     palpation. Once the individual present these muscle nodules can develop pain and motor~     dysfunction. Studies indicate that the prevalence of trigger points is 95% of individuals~     with chronic musculoskeletal pain, but this prevalence is not yet clear in individuals with~     low back pain.~      Objective: To compare the pain and function levels of patients with acute and chronic low~     back pain who, when asymptomatic, had trigger points compared to the pain and function levels~     of patients with acute and chronic low back pain who, when asymptomatic, had no trigger~     points.~      Study design: Cohort study, two arms, blind evaluator, prospectively enrolled at baseline.~      Location: This research will be conducted in the physiotherapy department at the~     Rehabilitation Center of the Brotherhood of Santa Casa de Misericórdia de São Paulo (ISCMSP).~      Patients: 400 asymptomatic individuals Follow-up: Asymptomatic individuals will be assessed~     at baseline and over 3 years. You will be asked to contact the research department within 6~     weeks of low back pain (acute) and after 12 weeks of low back pain (chronic). Participants~     will be allocated to two groups, trigger point group (n = 200) and group without trigger~     point (n = 200).~      Outcomes: The pain intensity, function level and trigger point pain intensity outcomes will~     be evaluated at the baseline, within 6 weeks for the patient to present pain in the lumbar~     (acute) and after 12 weeks the pain persists (chronic)~   "
34265|NCT03118050|"~     The proposed research is designed to identify the mechanisms that can accelerate loss of~     muscle size, strength and physical function in type 2 diabetes and with hospitalization in~     older persons. About ⅓ of older Americans have type 2 diabetes, and about ⅓ of the~     hospitalizations in the USA involve persons older than 65 year of age. The proposed research~     is relevant to the part of NIH's mission that pertains to development of the fundamental~     knowledge that will improve health and reduce the burdens of disability, because this work~     will provide the fundamental evidence to identify new targets for the development of~     innovative treatments to slow down muscle loss and disability in our aging society.~   "
34266|NCT03118037|"~     SAGE is an observational post market registry with the objective of characterizing long term~     outcomes after treatment of uterine fibroids with the Sonata System in real world clinical~     practice settings.~   "
34267|NCT03118024|"~     By comparison of two different protocols with diverse fluid/ catecholamine administration~     limits (fluid restriction vs. catecholamine restriction with target systolic blood pressure >~     100 mmHg) the investigators would like to reveal the impact of intraoperative blood pressure~     management on the survival rate of free deep inferior epigastric artery flaps for breast~     reconstruction.~   "
34268|NCT03118011|"~     In the department for substance use disorders at Uppsala University Hospital there are two~     wards. One that is locked, where the patients that are emitted can not go out to smoke and~     another ward where there is a possibility to go out and smoke during the day.~      The smoking habits on those two floors will be compared and how they feel about smoking will~     be evaluated when they are admitted to the ward, at discharge, after 1 mont and after 6~     months.~   "
34269|NCT03117998|"~     This is a randomized, placebo-controlled, double-blind study to evaluate the efficacy,~     safety, and pharmacodynamics (PD) of multiple doses of REMD-477 in subjects who have Type 1~     diabetes and are currently receiving insulin treatment. This study will determine whether~     REMD-477 can decrease daily insulin requirements and improve glycemic control after 12 weeks~     of treatment in subjects diagnosed with Type 1 diabetes with fasting C-peptide < 0.2 ng/mL at~     Screening.~      The study will be conducted at multiple sites in the United States. Approximately 75 subjects~     with type 1 diabetes on stable doses of insulin will be randomized in a 1:1:1 fashion into~     one of three treatment groups.~   "
34270|NCT03117985|"~     Phylogenic analysis of viruses hosted in marker positive reservoir cells including CD32a+ CD4~     T lymphocytes and rebounding viruses after treatment interruption~   "
34271|NCT03117972|"~     In first-line metastatic colorectal cancer (mCRC), baseline prognostic factors allowing death~     risk and strategy stratification are lacking. In this setting, a simple biological scoring~     system have recently been proposed, including LDH and CD138 binary status seric values,~     identifying one third of patients with worst prognostic.~      Intensified-chemotherapy strategies, combining 5-fluorouracile, Oxaliplatin, Irinotecan and~     Bevacizumab, are beneficial for patients having a bad prognostic, defined by the BRAFV600E~     mutation, concerning 5-8% of first line mCRC.~      For the 30% of patients with LDH-CD138 elevated score, the purpose of CLavSyn phase II study~     is to compare the PFS of one intensified arm (FOLFOXIRI Bevacizumab) to one standard~     chemotherapy arm, in order to better discriminate treatment strategies, at metastatic~     diagnosis.~   "
34272|NCT03117959|"~     The purpose of our study is to determine if anatomic/kinematic total knee arthroplasties~     (TKAs) are superior to mechanical axis-referenced TKAs with respect to determinants of gait~     functionality, patient satisfaction and other objective tests of knee function as a potential~     indicator of long-term prosthesis outcomes. To our knowledge there has not been any~     literature comparing TKAs using the kinematic and mechanical axes with respect to gait~     analysis. A single study has compared gender-specific TKAs and found that there is no~     difference with respect to determinants of gait when using these prostheses (Thomsen et al,~     2012), but again this study was not based on referencing off of the anatomical/kinematic axis~     of the knee. Our group is hoping that the small variability that may be detectable with the~     precision of gait analysis may be used as a predictor of future prosthesis outcome measures.~   "
34273|NCT03117946|"~     The aim of this study is to evaluate modulation of anti-tumor T cell responses in cancer~     patients treated by concomitant radiochemotherapy (i-RTCT)~   "
34274|NCT03117933|"~     The trial will compare the drugs olaparib and cediranib with standard chemotherapy in BRCA1/2~     mutated platinum resistant ovarian cancer. Patients will be randomised to one of three~     treatment groups: olaparib only, olaparib and cediranib and the control group paclitaxel. The~     aim is to compare efficacy of the 3 treatments and also how well each treatment is tolerated~     including the participants quality of life.~   "
34284|NCT03117803|"~     This is a registry study of the natural course of unruptured intracranial aneurysms (UIA). In~     addition, the investigators will analyze the risk factors for the rupture of the UIA and~     their joint effect. The investigators aim to use research data to create a China national~     database of UIA.~   "
34276|NCT03117907|"~     Despite advances in medicine, secondary neonatal infection remains a continuing concern~     because of the associated high morbidity and mortality. The usual mechanism of infection~     responds to the transmission of germs by the equipment used for care (eg, catheters) and by~     the hands of caregivers. In preterm infants in particular, some infections can also have an~     endogenous source, by translocation of colonization germs present in the digestive tract.~      The first line of prevention of secondary infection corresponds to compliance with the rules~     of hand hygiene, work surfaces and equipment carried out, the effect of which on the control~     of the incidence of secondary infection is regularly demonstrated. When declared, bacterial~     infection should be treated as quickly as possible with appropriate and effective antibiotics~     to preserve the healing prognosis. Compared to the infant and the larger child, clinical~     signs of calling are atypical and discrete. In the absence of staff trained to monitor~     newborns specifically, there is a real risk of discovering the existence of the infection~     only at an advanced stage corresponding, among other things, to circulatory collapse. This~     risk is not completely excluded, even with experienced practitioners, because the positive~     signs are rude and may go unnoticed (eg, signs of calling such as fever are rare in the~     newborn). Support for early diagnosis of neonatal infection by automatic monitoring systems~     has reduced mortality by 30% in the units where it has been applied. This is probably due to~     the fact that early warning made it possible to start the antibiotic treatment earlier and to~     complete the bacteriological diagnosis in order to better orient the therapeutic attitude.~     The best criteria for early diagnosis by automated systems were provided by the statistical~     analysis of cardiac variability, the results of the research and correspond to the standard~     deviation, the asymmetry and the entropy of the series d Cardiac intervals. Since microbial~     aggression has an impact on many vegetative variables outside of the electrocardiogram, our~     current research aims to determine whether the analysis of the perfusion index (PI) Which are~     of interest for detecting disturbances in the early stages of infection in newborns. IP~     corresponds to the ratio of the amplitude of the oscillating phase to the intensity of the~     constant part of the opto-plethysmography wave; It is obtained from signals recorded in a~     non-invasive manner by the same infrared sensor for pulse oximetry.~   "
34277|NCT03117894|"~     There is no consensus regarding which alternative is the best anesthesia for breast surgery,~     general anesthesia and morphine for postoperative analgesia or a combination of regional~     anesthesia and general anesthesia that possibly attenuates or abolishes the need for~     morphine.~      The current study aims to determine which of the two strategies that is best in relation to~     postoperative pain, nausea and risk of recurrence of the disease.~   "
34278|NCT03117881|"~     The purpose of this study is to compare the effects of two delivery models of an~     evidence-based complementary alternative medicine (CAM) program that combines~     neurorehabilitative (functional) exercise, yoga, and Pilates for adults age 18-70 with~     multiple sclerosis (MS). CAM will be delivered as a 12-week program through two different~     delivery forms: On-site at a clinic (DirectCAM) and telerehabilitation (TeleCAM).~     Participants will be randomly assigned to one of these two groups.~   "
34279|NCT03117868|"~     Fractures of the upper femur (EFSF) represent a major public health problem in the elderly.~     Approximately 1.6 million patients are victims each year of an EFSF and this number is~     increasing as a result of the aging of the population.~      In a recent Amiens retrospective study the mortality was estimated to be 22.5% at 1 year of~     the fracture. In surviving patients, the impact on loss of autonomy and degradation of~     quality of life is considerable.~      The reduction of the incidence of post-operative complications includes the identification of~     risk factors.~      No prospective study in Amiens has investigated the mortality and the study of the variables~     involved in the prognosis and long-term mortality of these patients.~   "
34280|NCT03117855|"~     This phase I trial studies the side effects of capecitabine and Y-90 radioembolization in~     treating patients with bile duct cancer in the liver that has spread to other places in the~     body and cannot be removed by surgery. Radiation therapy, such as Y-90 radioembolization,~     injects tiny radioactive Y-90 microspheres into the blood supply next to the liver tumors to~     kill tumor cells. Capecitabine may make radiation more effective. Giving capecitabine and~     Y-90 radioembolization may work better in treating patients with bile duct cancer in the~     liver.~   "
34281|NCT03117842|"~     In Cambodia, HIV is prevalent in several high-risk groups including among female~     entertainment workers (FEWs) who work at entertainment venues such as karaoke bars and~     massage parlors and may engage in direct or indirect sex work. Reaching FEWs with sexual and~     reproductive health services such as testing and treatment for HIV and sexually transmitted~     infections (STIs) and contraception has been difficult because they are hidden and~     stigmatized. Mobile phone-based interventions may prove to be an effective way to reach this~     population and connect them with the existing services. This article describes study design~     and implementation of a two-arm randomized controlled trial of a mobile health intervention~     (the Mobile Link) aiming to improve sexual and reproductive health outcomes among FEWs in~     Cambodia. A two-armed randomized controlled trial (RCT) will be used to determine the~     effectiveness of a mobile phone-based text/voice messaging intervention. The intervention~     will be developed through a participatory process; 50 FEWs will work alongside researchers in~     focus groups to modify and tailor behavior change theory-based text and voice messages. Then,~     600 FEWs will be recruited and randomly assigned into one of two arms: (1) a control group~     and (2) a mobile phone message group (either text messages or voice messages, delivery method~     chosen by participant). The primary outcome measures include HIV testing, condom use, STI~     testing and treatment and contraceptive use. If the Mobile Link trial is successful, an~     increase in condom use, screening and treatment for HIV and STI and contraception use is~     expected. These outcomes would lead to a reduction in the prevalence of HIV, STIs and~     unintended pregnancies. This trial is unique in a number of ways. First, the option of~     participation mode is offered to allow participants to choose the message medium that best~     links them to services. Second, this is the first RCT of a mobile phone-based behavior change~     intervention using SMS/VMs to support linkage to sexual and reproductive health services in~     Cambodia. Third, we are working with is a hidden, hard-to-reach and dynamic population with~     which traditional methods of outreach have not been fully successful.~   "
34282|NCT03117829|"~     Brief Summary:~      Project Summary Metabolic syndrome (MetS) is associated with the development of diabetes and~     cardiovascular disease; however it is also linked with cognitive decline and dementia. The~     study investigators have shown that MetS is associated with lower cerebral blood flow (CBF)~     and memory function in late middle-aged adults at increased risk for developing Alzheimer's~     disease (AD). Insulin resistance (IR) is at the core of MetS, and a hallmark feature of IR is~     higher fasting blood glucose (FBG) as well as post prandial hyperglycemia.~      While the study investigators and others have demonstrated links between IR and CBF as well~     as cognition from an observational perspective, no studies have investigated CBF and~     cognition after an intervention involving exercise and a carbohydrate restricted diet (CRD)~     designed to improve or normalize IR and glucose homeostasis. The study investigators propose~     to determine the effect of improving or normalizing glucose homeostasis on CBF and cognition,~     through diet and exercise, in individuals with IR and at risk for the development of AD.~      While exercise and a CRD have been shown to improve IR and glycemic control, we have only~     limited knowledge of the mechanisms behind these improvements. Nutritional metabolomics, the~     global measurement and interpretation of metabolic profiles, assesses the interaction of diet~     with the endogenous gene-protein cascade and the gut microbiome. Additionally, exercise has~     been shown to have an impact on the human metabolome. Finally, numerous metabolites have been~     specifically linked to IR and impaired fasting glucose (IFG). The study investigators propose~     to use metabolomics to measure changes in metabolites as individuals normalize or improve IR~     and glucose homeostasis.~      Should this exploratory study reveal increased brain blood flow and improved memory in~     response to diet and exercise, then early treatment of these individuals at risk might offer~     new avenues for disease-course modification. Strategies towards early and effective risk~     factor management could be of value in reducing the risk of metabolic as well as cognitive~     decline. In addition, should this study reveal changes in metabolic abnormalities consistent~     with early indications of diabetes, metabolomics could be an effective approach to complement~     disease risk analysis in our goal toward precision care.~   "
34283|NCT03117816|"~     A randomized, open-label assessor blinded, multi-center, controlled phase II Trial to~     evaluate the efficacy of AOP2014 administered bi-weekly subcutaneously (s.c.) in preventing~     molecular relapse (loss of MMR) in CML patients, who discontinue ABL tyrosine kinase~     inhibitor therapy (TKI) in deep molecular remission of MR4 or better (MR4.5, or MR5).~   "
34285|NCT03117790|"~     Sleep disturbances frequently occur in elderly patients after major surgery; and their~     occurrence are associated with worse outcomes including increased incidence of delirium.~     Previous studies showed that, for elderly patients admitted to the ICU after non-cardiac~     surgery, low-dose dexmedetomidine infusion improved to some degree the quality of sleep and~     reduced the incidence of delirium. The investigators hypothesize that, for elderly patients~     after major non-cardiac surgery, dexmedetomidine supplemented analgesia can also improve the~     sleep quality. The purpose of this randomized controlled pilot study is to investigate the~     impact of dexmedetomidine supplemented analgesia on the sleep quality in elderly patients~     after major non-cardiac surgery.~   "
34286|NCT03117777|"~     This is a quality assurance project to evaluate a therapy program offered to patients in~     Sleep Disorders Clinic. Group Cognitive Behavioral Therapy for Insomnia (CBT-I) is being~     offered to older adults. The study will consist of analyzing outcomes of a clinical program.~     As part of standard clinical process, patients complete measurements of sleep, daytime~     functioning, fatigue, quality of life, depression and anxiety symptoms before and after the~     treatment. The proposed study will pool and quantitatively analyze the existing clinical~     data. Only those program participants who consent to have their data pooled in the data~     analysis will be considered research subjects. Those patients who decline to have their~     individual data included in the analysis will continue in the therapeutic group as per usual~     clinical care standards.~      CBT-I is a gold standard treatment for people suffering from insomnia but it is difficult to~     access due to a shortage of trained therapists. Insomnia prevalence increases with age and is~     a common sleep disturbance in the elderly. Offering the group treatment can increase access~     and reduce healthcare costs associated with sleep problems in the elderly.~   "
34287|NCT03117764|"~     The investigators know that peripheral muscle weakness and exercise intolerance are prevalent~     (56%) in cystic fibrosis (Trooster et al, 2009). Physical inactivity is likely to be an~     important underlying factor. Those conditions are associated with a poor prognosis (Nixon et~     al, 1992). The effect of intravenous antibiotherapy on peripheral muscle and physical~     activity remains unclear.~      The aim of the study is to evaluate the impact of intravenous antibiotherapy on peripheral~     muscular strength in patients with cystic fibrosis (adults and children) who receive~     intravenous antibiotherapy for an acute exacerbation or electively (decline in lung function~     without exacerbation).~   "
34288|NCT03117751|"~     The overarching objective of this study is to use novel precision medicine strategies based~     on inherited and leukemia-specific genomic features and targeted treatment approaches to~     improve the cure rate and quality of life of children with acute lymphoblastic leukemia (ALL)~     and acute lymphoblastic lymphoma (LLy).~      Primary Therapeutic Objectives:~        -  To improve the event-free survival of provisional standard- or high-risk patients with~          genetically or immunologically targetable lesions or minimal residual disease (MRD) ≥ 5%~          at Day 15 or ≥1% at the end of Remission Induction, by the addition of molecular and~          immunotherapeutic approaches including tyrosine kinase inhibitors or blinatumomab for~          refractory B-ALL, and the proteasome inhibitor bortezomib for those lacking targetable~          lesions.~        -  To improve overall treatment outcome of T-ALL by optimizing pegaspargase and~          cyclophosphamide treatment and by the addition of new agents in patients with targetable~          genomic abnormalities (e.g., activated tyrosine kinases or JAK/STAT mutations) or by the~          addition of bortezomib for those who have a poor early response to treatment but no~          targetable lesions.~        -  To examine in a randomized study design whether the administration of one dose of~          rituximab to children with B-ALL during early Remission Induction therapy decreases~          allergic reactions to pegaspargase.~        -  To determine in a randomized study design whether the incidence and/or severity of acute~          vincristine-induced peripheral neuropathy can be reduced by decreasing the dosage of~          vincristine in patients with the high-risk CEP72 TT genotype or by shortening the~          duration of vincristine therapy in patients with the CEP72 CC or CT genotype.~      Secondary Therapeutic Objectives:~        -  To estimate the event-free survival and overall survival of children with ALL and LLy.~        -  To examine whether the administration of one dose of rituximab can lower the minimal~          residual disease (MRD) levels.~        -  To determine the tolerability of combination therapy with ruxolitinib.~      Biological Objectives:~        -  To use data from clinical genomic sequencing and sequencing-based MRD in bone marrow,~          blood and cerebrospinal fluid.~        -  To assess clonal diversity and evolution of pre-leukemic and leukemic populations.~        -  To identify germline or somatic genomic variants associated with drug resistance of ALL~          cells.~        -  To compare drug sensitivity of ALL cells from diagnosis to relapse.~      Supportive Care Objectives~        -  To conduct serial neurocognitive monitoring of patients and to evaluate the benefits of~          a computer-based cognitive intervention.~        -  To evaluate the impact of low-magnitude high frequency mechanical stimulation on bone~          mineral density and markers of bone turnover.~      Exploratory Objectives:~        -  To identify pharmacogenetic, pharmacokinetic and pharmacodynamic predictors of treatment~          outcome.~        -  To perform a detailed assessment of thiopurine metabolism and 6-mercaptopurine (6MP)~          tolerance, toxicity, and treatment outcome.~        -  To establish xenografts of representative subtypes of ALL.~        -  To prospectively determine the risk and epidemiology of breakthrough infection or~          febrile neutropenia and adverse effects of antibiotics.~   "
34289|NCT03117738|"~     This is a randomized, double-blind, placebo-controlled, parallel-group comparison study in~     subjects with Alzheimer's Disease. Following first screening period, subjects will be~     randomly assigned into one of the following arms: AstroStem and placebo control in a 1:1~     ratio. AstroStem or placebo control will be administered via I.V. at Week 0. This procedure~     will be repeated 9 times at 2-week interval. Subjects will be scheduled for two follow-up~     visits at Weeks 30 and 52 to evaluate primary and secondary outcome endpoints.~   "
34290|NCT03117725|"~     Poor sleep quality may lead to increase in oxidative stress and free radicals which in turn~     may decrease the reproductive function. Many researchers have already proven improvement on~     reproductive function after antioxidant (melatonin) administration. The investigators wish to~     study the relationship between unexplained, young poor ovarian responder and oxidative~     stress.~   "
34291|NCT03117712|"~     Postoperative delirium is an acute and fluctuating state of confusion and disorientation with~     an incidence of 25-70% after cardiac surgery. Possible reasons for this multifactorial~     complication are hypoperfusion, cerebral microembolization and inflammatory response, which~     eventually lead to regional or global imbalance between cerebral oxygen demand and supply.~     Adequate cerebral blood supply depends sufficient blood supply via the vertebral arteries and~     the internal carotid arteries. The aim of this preliminary study is to investigate if~     patients who develop delirium after open-heart surgery show differences in their cerebral~     blood flow during cardiopulmonary bypass (CPB) in extracerebral arterial vessels compared to~     those patients without delirium.~   "
34292|NCT03117699|"~     This is a study for a new mechanical transport device adapted to the hemiplegic patients.~      Healthy volunteers :~      After explaining the protocol and presenting the movement laboratory, the subjects are~     equipped with reflective markers on the 4 limbs, the trunk and the head. The subjects are~     installed on a seat positioned in front of 2 force platforms installed on the ground. The~     seat is equipped with a force platform.~      Phase 1 :~      After being seated, the subject realizes :~        -  3 seat to stand and stand to seat without assistance~        -  3 seat to stand and stand to seat using a handle located in front of it (handle equipped~          with a 6-axis force sensor)~        -  3 seat to stand and stand to seat using the experimental device This phase will last~          45minutes (mn) (30mn of equipment and 15mn of sitting passengers standing)~      Phase 2:~      After being seated, the subject performs a course comprising:~        -  A standing pass from sitting on a chair~        -  A straight line movement~        -  A succession of left and right turns~        -  An upward and downward travel of less than 1%.~        -  Standard doorway~        -  Standing on the toilet~        -  A sitting pass from the toilet~        -  One way to a bed~        -  A sitting pass on the bed~        -  A passenger seat sitting upright from the bed~        -  A return to the starting point~        -  A sitting pass on the starting chair Each stage is timed. A subjective analysis of each~          step is done by a lickert scale on the perceived comfort and safety.~      This phase 2 will last 30mn (15mn of course and 15mn of questions).~      Hemiplegic subjects :~      At each session, the subject is examined by a physician who evaluates the motor control (Fugl~     Meyer scale), the equilibrium (Berg scale) and the spatial hemineglect (Bergego scale).~      Phase 1 is performed except the 3 seat to stand and stand to seat without assistance which~     are impossible.~      Phase 2 is performed. An evaluation of the device over 4 hours is carried out for each~     subject in therapeutic apartment in simulated living conditions. The validation in living lab~     is carried out by an ergonomist and by a questionnaire on the comfort and safety of the~     various steps identified by the ergonomist.~   "
34293|NCT03117686|"~     High altitude pulmonary edema is a life-threatening condition that remains a concern for~     climbers and clinicians alike. It is defined as a non-cardiac pulmonary edema occurring at~     altitudes exceeding 3000m in non-acclimatised individuals. Recently, studies conducted in~     remote areas have demonstrated that ultrasound lung comets (B lines) can be used as a measure~     of sub-acute pulmonary edema and high altitude pulmonary edema in climbers ascending to~     altitude. the investigators want to assess the occurrence of of comet tails (B lines) as a~     measure of pulmonary edema among patients after lung transplantation and healthy individuals~     during an expedition to Mount Kilimanjaro.~   "
34352|NCT03116919|"~     White potatoes have recently been allowed back in the cash value voucher of the government~     food stamp program after it was stated that there were no known adverse health effects of~     potatoes. However, the association of potatoes with heart health, especially elevated blood~     pressure is not known. This study will examine the effects of potatoes on blood pressure in~     different populations of adults and children, and assess, in a feeding trial, the effects of~     an additional serving of potatoes per day on the possible mechanisms that link potatoes to~     high blood pressure. The investigators will also analyze the intake of potatoes in~     participants of the government food stamp program.~   "
34294|NCT03117673|"~     Transesophageal echocardiography (TEE) plays an important role in intraoperative monitoring~     and can be used to estimate pulmonary artery pressures. An excellent correlation between~     right ventricular systolic pressure (RVSP) measured by right heart catheterization (RHC) and~     simultaneously estimated by transthoracic echocardiography is reported and also implemented~     into the current guidelines for the echocardiographic assessment of the right heart in adults~     by the American Society of Echocardiography. So far there are no studies evaluating RVSP~     measured by transesophageal echocardiography (TEE) and recommendations are unclear which~     transesophageal view is the best for calculation.~      We want to assess if there is a difference in the systolic pulmonary artery pressure measured~     invasively with a pulmonary artery catheter (PAC) and the calculated right ventricular~     systolic pressure (RVSP) using transesophageal echocardiography (TEE) in 3 different views:~     ME 4Ch, ME RV inflow-outflow, ME modified bicaval.~   "
34295|NCT03117660|"~     Prospective drug interaction study during pregnancy.~   "
34296|NCT03117647|"~     Postpartum hemorrhage is the leading cause of maternal, uterine atony accounts for 75-90% of~     primary postpartum hemorrhage. The efficacy of the Uterine compression suture in the~     treatment of atonic postpartum hemorrhage is time-tested and can be said to be almost~     established .The aim of this study was to assess the role of the Mansoura-VV uterine~     compression suture as an early intervention in the management of primary atonic postpartum~     hemorrhage.~   "
34297|NCT03117634|"~     Polypoidal choroidal neovasculopathy (PCV) is a subtype of wet age related macula~     degeneration (AMD) occuring more commonly in the Asian population. Besides the phenotypic~     differences, PCV is thought to have a lesser response to anti VEGF therapy which is the~     mainstay of treatment for other typical wet AMD. Recent trial data suggest that a combination~     with photodynamic therapy may help in the visual and anatomical outcome of PCV, and emerging~     evidence shows favourable outcomes the newer anti VEGF agent, aflibercept 2mg monotherapy.~     These trials however, have assessed aflibercept in a strict 2mg every 8 weekly regime.~      In the clinical setting, a significant an unmet need in the management of PCV is a tailored~     treatment regime. Here we propose a treatment regimen based on disease activity for PCV with~     aflibercept mono therapy. A limitation of the 2q8 regime is that it is fixed and does not~     vary regardless of polyp closure or anatomical outcome at the first time point of assessment~     (month 3). We hypothesize that after the initial 3 monthly injections of aflibercept, about~     50% of PCV will close and become quiescent, and in the remaining 50%, a further 3 monthly~     injections will increase overall polyp closure rate. After a loadings phase of either 3 or 6~     months, all eyes will start on a treat and extend regime (T&E), with a minimum period of 8~     weeks and a maximum of 12 weeks between treatments with 2 week increments if PCV remains~     quiescent. The proposed study aims to evaluate the efficacy of a modified treat and extend~     regime based on disease activity with aflibercept monotherapy for PCV.~   "
34298|NCT03117621|"~     An observational study of blinatumomab safety and effectiveness, utilisation, and treatment~     practices~   "
34299|NCT03117608|"~     The study proposes to compare performances and safety of intra-articular injections of aMAT~     with those of a control group (PRP injections) for the treatment of symptomatic OA of the~     knee. The end-points will be determined evaluating the performances of the treatment group in~     terms of improvement of the symptomatology, functional recovery and radiological appearance.~   "
34300|NCT03117595|"~     Analgesia in labour is not readily available in many parts of Sub-Saharan Africa. The overall~     cost of Epidural services in terms of human personnel and financial implication makes this~     inaccessible to many women in labour. Thus, a cheaper, less technically demanding and easier~     option that can produce as much satisfaction for the parturient and would allow her~     participate in the second stage of labour by being able to bare down is being studied.~      The Single Shot Spinal (SSS) would provide pain relief in these women however its draw back~     is its time limitation as the option of a top up is not available.~      Two regimen of drug options would be considered using opioids. These would be compared to see~     how well they are able to provide analgesia in women who hitherto have had vaginal birth.~     Their onset, duration of action and possible side effects would be compared.~      NULL HYPOTHESIS: Single Shot Spinal with Bupivacaine Fentanyl (BF) cannot provide a~     statistically significant difference in labour analgesia in comparison with Bupivacaine~     Fentanyl Morphine (BFM) ALTERNATE HYPOTHESIS: Single Shot Spinal with BF can provide a~     statistically significant difference in labour in comparison with BFM~   "
34301|NCT03117582|"~     Purpose: To study the changes in the microbiome and stool composition in patients with~     Clostridium Difficile Infection (CDI) who undergo Fecal Microbiota Transplantation (FMT),~     along with changes in their clinical characteristics.~   "
34302|NCT03117569|"~     The aim of this study is to determine if treatment monitoring schedule for chronic HCV~     patients treated with glecaprevir (300mg)/pibrentasvir (120mg) can be simplified.~      Data has shown that direct acting antiviral (DAA) regimen of glecaprevir (300mg)/pibrentasvir~     (120mg), a protease inhibitor and NS5A inhibitor respectively , provides key features for HCV~     treatment simplification.~      Eligible participants (naïve pre-cirrhosis chronic HCV patients) will be randomized (1:2) to~     the standard or simplified monitoring arm and will receive treatment for 8 weeks.~      One post treatment visit will be conducted 12 weeks after the final dose of study medication~     to evaluate the proportion of patients with undetectable HCV RNA at this timepoint (SVR12).~   "
34303|NCT03117556|"~     This study aims to compare the efficacy of bilateral thoracoscopic splanchnicectomy (BTS) to~     conventional narcotic analgesia for control of abdominal pain in patients with pancreatic~     ductal adenocarcinoma not amenable to surgical resection.~   "
34323|NCT03117296|"~     Implementation of Physical Therapy (PT) and Occupational Therapy (OT) pathway (initiation of~     services on Post procedure day #1 and continued daily with focus on education and activity~     progression) for all patients undergoing a transcatheter aortic value repair procedure began~     on December 2, 2014. Retrospective data was collected from The Society of Thoracic~     Surgeons/American College of Cardiology Transcatheter Aortic Valve Replacement Procedures~     (STS/ACC TVT, trademark) Registry - National database for Transcatherter Aortic Valve~     Replacement Procedures and included subjects from March 2012 through July 31, 2015. Patients~     included: s/p tAVR via transfemoral catheter approach, with or without minor intra or post~     procedure events (GI bleeds, minor access bleeds, afib, etc); Exclusions: Major events~     including stroke, pacemaker placement, other cardiovascular (CV) repair or surgery required,~     etc). Future data analysis will extend subjects to December 31, 2015 and annually.~   "
34304|NCT03117543|"~     Gestational diabetes (GDM) means raised blood glucose found for the first time in pregnancy.~     GDM is common, particularly in women from minority ethnicities. GDM does not cause any~     symptoms in the mother. GDM is associated with adverse pregnancy outcomes which can be~     improved with treatment of GDM. The United Kingdom National Institute for Health and Care~     Excellence (NICE) recommend pregnant women with one or more risk factors should have a 75g~     oral glucose tolerance test (OGTT). The OGTT is performed in a clinic with venous plasma~     glucose measured fasting and at 2 hours. This is resource-intensive, and some women with GDM~     may be missed by this risk-factor based approach. The International Association of Diabetes~     and Pregnancy Study Groups (IADPSG 2010) recommends screening all pregnant women with 2-hour,~     3 sample (fasting, 1 and 2 hour), 75g OGTT, which is even more resource intensive. Developing~     more cost-effective and convenient approaches to screening for GDM is a priority.~      The researchers will validate a new home-use OGTT system (hOGTT), which measures whole blood~     glucose in capillary blood ('finger-stick' sample), against the gold standard venous plasma~     glucose in pregnancy.~      The researchers will also investigate the performance of glycated haemoglobin (HbA1c) in~     screening for GDM. HbA1c is used for diagnosis of diabetes outside of pregnancy, but is~     currently not recommended for screening for GDM.~      The researchers will also investigate relationships between glucose measured in different~     samples (venous versus capillary), different fractions (plasma versus whole blood), and using~     different methods in pregnancy.~      In a substudy the researchers will investigate: ethnic differences in HbA1c and other~     glycaemic markers; the contribution of fasting and postprandial glucose handling, diet and~     ethnicity on HbA1c; and ethnic differences in insulin responses to 75g OGTT in pregnancy.~      The researchers will invite pregnant women between 16-34 weeks gestation to participate. The~     research involves one hospital visit for an OGTT. Participants will have venous blood samples~     taken fasting and at 1-hour and 2-hours, and at the same times finger-stick blood samples~     will be tested. The researchers will invite women of Black African, Black Caribbean and White~     European ethnicity to participate in a substudy in which participants will have extra blood~     taken and a diet assessment.~      If the hOGTT provides accurate results in pregnancy, using it to perform OGTTs at home would~     make screening for GDM less expensive and more convenient and may facilitate universal~     screening for GDM. Understanding ethnic differences in HbA1c will help determine if HbA1c is~     a reliable screening tool for GDM in our ethnically diverse local population.~   "
34305|NCT03117530|"~     Autism spectrum disorders (ASD) are highly disabling, persistent neurodevelopmental~     disorders. There are no available treatments for core symptoms of ASD or biologically-based~     clinical biomarkers. Emerging evidence indicates that levels of brain inflammation are~     increased in ASD. In particular, recent work implicates hyperactivity of microglial cells,~     the resident immune cells of the brain. However, the functional consequences of microglial~     activation remain unknown. This study will measure microglial activation in ASD using~     positron emission tomography (PET) brain imaging. Adult males with ASD (n=15) and healthy~     controls (n=15) will be recruited for this study and undergo comprehensive clinical and~     behavioral baseline assessment. All subjects will then undergo baseline PET imaging using a~     radiotracer that labels activated microglia. Subjects with ASD will then undergo 12-week open~     label treatment with minocycline, an FDA-approved antibiotic thought to block microglial~     activation. PET imaging will be repeated at 12 weeks to confirm target engagement. A subset~     of control subjects will also undergo repeat PET imaging to determine test-retest~     reliability. During minocycline treatment, ASD subjects will be evaluated every 2 weeks for~     safety, clinical impression, behavioral functioning, and measures of cognition. Results will~     provide important information regarding the relationship between levels of brain~     inflammation, cognitive and behavioral function in ASD.~   "
34306|NCT03117517|"~     Objective:~        1. To investigate the changes in the levels of interleukin-6 and interleukin-8 after 3~          months treatment with metformin alone and combination of metformin and pioglitazone in~          patients with polycystic ovarian syndrome (PCOS).~        2. To evaluate insulin resistance in all the groups at baseline and after 3 months of~          treatment.~      Design: Two-Arm Randomized Clinical trial.~      Setting: Out-Patient Department (OPD) of Mardan Medical Complex, Khyber Medical University.~      Patient(s): One hundred and two patients with PCOS.~      Intervention(s): 51 women will receive metformin according to the body weight with maximum~     dose of 1000 mg (BD) daily. Remaining 51 will receive metformin and pioglitazone combination~     according to the body weight with maximum dose of 1000 mg and 30 mg (BD) daily.~      Main outcomes measure(s): Serum concentrations of fasting blood glucose, insulin, homeostatic~     model assessment for insulin resistance (HOMA-IR), follicle stimulating hormone (FSH),~     luteinizing hormone (LH), interleukin-6 (IL-6) and i-nterleukin-8 (IL-8).~   "
34307|NCT03117504|"~     Stress urinary incontinence is the most common type of incontinence during pregnancy.our~     study aims at determining the prevalence in the first and third trimesters and the associated~     risk factors.~   "
34308|NCT03117491|"~     Introduction: to evaluate the efficacy of inferior alveolar nerve block (IANB), Gow-Gates~     nerve block (GGNB), and their combination in patients with irreversible pulpitis. Methods:~     One hundred fifty subjects with irreversible pulpitis of a mandibular molar were selected.~     subjects randomly received two IANB injections or two GGNB injections or their combination of~     1.8 mL 2% lidocaine with 1:100,000 epinephrine. Success was specified as no or mild pain on~     the basis of Heft-Parker visual analogue scale recordings up on the access cavity preparation~     or initial instrumentation. Data were analyzed by Kruskal-Wallis, and ANOVA tests.~   "
34309|NCT03117478|"~     The main aim of this project is to explore the neuro-anatomical and -physiological correlates~     of meditation on attention and emotion-regulation. By investigating this, our scientific goal~     is to more generally identify the mechanisms and biomarkers of health and mental well-being.~     Therefore, the investigators use non-invasive imaging like Magneto-EncephaloGraphy (MEG),~     ElectroEncephaloGraphy (EEG), functional and anatomic Magnetic Resonance Imaging (MRI;~     including Diffusion tensor - DTI). These brain measures will then be linked to behavioral~     measurements. Experimental methods (i.e., simple computer tasks) will be used to measure~     attention, conscious perception and regulation of pain and emotion.~   "
34310|NCT03117465|"~     To apply Bold-fMRI technology to observe and compare the differences of task-related~     activation of relevant brain cortex region in stroke hemiplegic patients and healthy subjects~     after finger grasping movement.~   "
34324|NCT03117283|"~     Bursectomy is widely performed in open surgery for advanced gastric cancer in East Asia.~     However laparoscopic D2 radical total gastrectomy with complete bursectomy is difficult and~     rare performed. Herein, we conduct a single-centre randomized controlled trial to explore the~     safety and feasibility of totally laparoscopic D2 radical total gastrectomy using a left~     outside bursa omentalis approach for achieving complete bursectomy.~   "
34325|NCT03117270|"~     This is a multicenter, Phase 2, double-blind, placebo-controlled study in subjects with~     active Ankylosing Spondylitis (AS). A total of approximately 100 subjects will be randomized~     to one of 2 treatment arms in a 1:1 ratio: oral filgotinib tablets q.d. or matching placebo~     q.d. Treatment duration will be 12 weeks. Each subject will stay in the study for a maximum~     of 20 weeks (from Screening visit to Follow-up visit).~   "
34410|NCT03116152|"~     Efficacy and safety evaluation of IBI308 versus paclitaxel/irinotecan in patients with~     advanced/metastatic esophageal squamous cell carcinoma after failure of first-line treatment:~     a randomized, open-label, multicenter, phase 2 study~   "
34311|NCT03117452|"~     Schizophrenia is a severe psychiatric condition that is associated with significant distress~     and disability. In addition to cognitive difficulties in domains such as attention, memory,~     and problem-solving, individuals with schizophrenia can experience visual-processing~     abnormalities, including impairments in visual acuity, low-contrast stimulus detection, and~     perceptual organization (i.e., perceiving visual information in an organized perceptual~     whole). These visual impairments are clinically significant, with research indicating that~     specific visual-processing alterations are significantly related to poorer performance on~     higher-level cognitive tasks, impaired facial emotion recognition, impaired reading ability,~     and worse functional outcomes. Despite such findings, very few studies have evaluated the~     therapeutic potential of interventions that are specifically designed to improve visual~     processing (visual remediation) for individuals with schizophrenia. Thus the aim of this~     study is to evaluate the efficacy of a computerized visual perceptual training program that~     targets low- and mid-level visual processes to improve visual, cognitive, and~     emotion-recognition functions in outpatients with schizophrenia through a small randomized~     controlled trial. The investigators will recruit up to 40 individuals with schizophrenia or~     schizoaffective disorder who are receiving treatment in Rutgers University Behavioral Health~     Care (UBHC) Partial Hospital Program; half will be randomized to receive the computerized~     visual training, which will be delivered in small groups over a period of 12-14 weeks. The~     specific aims of this study are to collect preliminary data on: 1) the feasibility of~     participant recruitment and retention, and tolerability of the treatment components of the~     study; and 2) the efficacy of computerized visual training (VT) to improve low- and mid-level~     visual processes, and higher-level cognitive and social-cognitive performance. Based on~     preliminary data, the investigators hypothesize that the target number of participants will~     be successfully recruited and engaged in the VT intervention (n=16) and control condition~     (n=16), and that the participants who receive VT will demonstrate greater improvements on~     measures of low- and mid-level visual, higher-level cognitive, and social-cognitive functions~     compared to those who receive standard partial-hospital care without VT. The results of this~     initial trial will be used to inform the design and application for funding of a larger-scale~     investigation of visual remediation for individuals with schizophrenia.~   "
34312|NCT03117439|"~     This study is aimed to compare the duration of standard anti fungal therapy in high risk ICU~     patients with a strategy driven by BetaDGlucan test result~   "
34313|NCT03117426|"~     Since the introduction of intraocular lenses (IOL) in the treatment of cataract, the~     postoperative accommodative loss of the human eye has been a trending topic. Numerous studies~     show a high rate of spectacle-independency after bilateral implantation of multifocal IOLs~     (MIOL). However, glare, halos, and reduced visual acuity under different light conditions are~     common complaints after MIOL implantation. Due to its unique design, the TECNIS® Symfony~     Extended Range of Vision ZXR00 IOL (Abbott Medical Optics, Santa Ana, USA, hereinafter~     referred to as Symfony IOL) is theoretically providing a continuous range of high-quality~     vision for far, intermediate, and near distances with the same low incidence of halos and~     glare associated with monofocal IOLs under different light conditions.~      The goal of this study is to compare the AT LISA tri 839MP IOL (Carl Zeiss Meditec AG, Jena,~     Germany, hereinafter referred to as AT LISA IOL) versus the Symfony IOL in terms of~     postoperative achieved visual acuity at different distances, patient satisfaction (e.g.~     spectacle-independency, QoL), and postoperative complication profile (e.g. halo's and glare)~     under different light conditions. So far, there are no published studies comparing both IOLs.~     Therefore, we will perform this randomized control trial.~   "
34314|NCT03117413|"~     Our main objective is to study how the extent of reorganization of the central auditory~     system is related to the binaural integration in cochlear implanted subjects with asymmetric~     hearing loss. Subjects with asymmetric hearing loss treated with a cochlear implant and a~     control group of normal hearing subjects will perform two tests for binaural integration~     (speech recognition in noise and spatial localization) and two tasks of non-linguistic sounds~     perception.~   "
34315|NCT03117400|"~     To date there are no available data on the utility of the endoscopic mucosal resection (EMR)~     defect in stratifying the risk of immediate or delayed adverse outcomes, particularly~     clinically significant post EMR bleeding (CSPEB).~      The investigators aimed to analyse the data to determine if any of these EMR defect features~     allow us to estimate the risk of CSPEB. This will help endoscopists to identify defects with~     a high risk of adverse outcomes and may translate into improved patient outcomes.~   "
34316|NCT03117387|"~     Acceleromyography (AMG) is the most wide spread used method to assess neuromuscular block~     during anesthesia. However AMG is known to be inaccurate when compared to the gold standard~     in neuromuscular transmission monitoring, electromyography (EMG). Furthermore when the~     patients arms require to be positioned next to the body and beneath surgical drapes, AMG~     measurements are often hindered and inaccurate. The TOF cuff is a new device which measures~     NMB at the upper arm with a blood pressure cuff. It overcomes the previously mentioned~     disadvantages of AMG. However, it validity compared to EMG and AMG has not yet fully been~     investigated.~      This study aims to compare the bias, limits of agreement and precision of the TOF cuff~     relative to AMG and EMG during recovery of moderate and deep neuromuscular block in patients~     with normal body mass index and morbidly obese patients.~   "
34317|NCT03117374|"~     The goal of this study is to evaluate the impact of an innovative web-based school nutrition~     intervention (Team Nutriathlon) aimed at promoting the consumption of vegetables and fruit~     and dairy products in high school students and to identify facilitators and/or barriers~     influencing its success.~   "
34318|NCT03117361|"~     This is a multi-center, open-label, single arm, non-comparative phase II trial, designed to~     evaluate the efficacy of plitidepsin in combination with bortezomib and dexamethasone in~     patients with Multiple Myeloma (MM) double refractory to bortezomib and lenalidomide.~   "
34319|NCT03117348|"~     Patients will be randomized to Gradual or immediate Goal-dose EN group at day 3 after~     abdominal surgery. Patients will receive Goal-dose EN gradually or immediately after~     abdominal surgery. Both groups will receive EN for 5 days except 80% of target energy~     delivered by oral feeding or patients are discharged from hospital. The primary and secondary~     outcomes will be collected.~   "
34320|NCT03117335|"~     The main object of this trial is to offer treatment of recombinant endostatin ( Sulijia)~     combined with Vinorelbine and Cisplatin (NP) plus maintenance therapy with Sulijia for~     advanced Non-small Cell Lung Cancer, expecting to improve progression free survival (PFS) ,~     disease control rate(DCR) , objective response rate(ORR) and Overall survival (OS) compared~     with chemotherapy alone, and evaluate the efficacy and safety of Sulijia.~   "
34321|NCT03117322|"~     Randomized double blind controlled clinical trial. Participants will be enrolled at the New~     Civil Hospital of Guadalajara Dr. Juan I. Menchaca during the period from May 2017 to July~     2018, from six to 59 months of either sex. The duration of each participant in the study will~     be of four weeks. Each participant will be randomized assigned to any of the different study~     groups: synbiotic, prebiotic, probiotic or placebo. Hypothesis: The efficacy of~     supplementation with a symbiotic, a prebiotic and a probiotic differs in its beneficial~     effect on the intestinal microbiota and the characteristics of feces in children with CP and~     chronic constipation.~   "
34322|NCT03117309|"~     Phase II trial of nivolumab in 120 treatment naïve patients with ccRCC.~   "
34327|NCT03117244|"~     The human foot allows to perform several functions, rather than providing a Static support~     for the body, the foot acts dynamically in walking and Movement of the body, requiring~     adequate biomechanics responsible for Maintenance and posture of the body and harmonic~     distribution of plantar pressure.~      One of the most important structures for this control is the medial plantar vault (MPA), an~     important structure in the absorption of impact and essential for the function Foot. The~     deformation of the MPA in the gait support phase absorbs the Energy and propels the limb, to~     perform this biomechanical function the MPA must Stable from the anatomical point of view,~     which is conferred by the bone architecture and But also by the performance of the intrinsic~     and extrinsic musculature of the Feet. The fall of the MPA, decreases the stability of the~     foot, limits its biomechanical function,~      Besides being a risk factor for the development of pathologies such as:~      Tendinopathy of the calcaneus tendon and plantar fasciitis. Various Intrinsic Muscles And~     extrinsic have the function of stabilizing the foot and the MPA, being the main Extrinsic~     muscles: the posterior tibial, the flexor long of the hallux and the fingers. The Muscles~     when activated increase the height and decrease the Length of the MPA. Several methods are~     used to evaluate ALM, such as (AN), Feiss line (LF) and MPA angle (MPAH), in addition to the~     Baropodometry, which is used to evaluate dysfunctions in the feet, with the principle of Map~     the pressure of the plantar surface in a static and dynamic way. Based In this information,~     this study aims to evaluate the influence of the Strengthening of the intrinsic and extrinsic~     muscles of the feet, for the Of MPA in asymptomatic patients.~   "
34328|NCT03117231|"~     The purpose of this study is to evaluate if anodal tDCS stimulation over M1 may decrease~     chronic knee OA pain in elderly subjects with defective CPM. In addition, this trial will~     help to investigate the role of central sensitization in knee OA and evaluate how tDCS~     stimulation may affect it.~   "
34329|NCT03117218|"~     This study aims to evaluate whether quantitative analysis of coronary MR angiogram would~     improve the detection of functionally-significant coronary artery stenosis.~   "
34330|NCT03117205|"~     Background: Recently, several professionals are using the Kinesio Taping® in the treatment of~     pathologies related to the knee, aiming to improve the motor control, increase the response~     of muscle activation and promoting better joint stability.~      Purpose: The objective of this study is to evaluate the effect of the application of Kinesio~     Taping® in motor control of patients with patellofemoral pain syndrome.~      Methods: This is a 2-arm, randomized with a blinded assessor. We selected 40 women with~     patellofemoral pain (age 25.2±4,years) were randomly assigned to one of two groups: placebo~     group (n= 20) and the Kinesio Taping® group (n=20). The placebo group received the~     application of a non-stretchable tape (Micropore) crosswise on the thigh and the Kinesio~     Taping® group followed all the criteria of the method in placing the bandage. All patients~     received the evaluation of the motor control banding pre and post a patch, by means of the~     method Y balance test.~   "
34331|NCT03117192|"~     Randomized controlled trial was conducted in post-splenectomy patients aged >12 years.~     Subjects are randomly assigned to two groups (zinc and placebo). 1.5 mg/kg/day (max 50~     mg/day) of Zinc is administered.~   "
34332|NCT03117179|"~     Each year more than 15 million French people visit the emergency services and almost 80% of~     them come out without hospitalization after having undergone a clinical examination and~     possibly additional examinations.~      Following their discharge, compliance with discharge requirements and recommendations~     (treatment, monitoring, follow-up, etc.) is a determining factor in improving their health.~     Non-membership is linked to an increase in morbidity, mortality and use of the health system.~     Patient adherence to discharge instructions is conditional on patient understanding.~     Unfortunately, the environment of an emergency service often creates conditions for~     information and education of the patient that are often far from optimal or at least that are~     specific to a typical consultation.~      Data from the international literature showed that 78% of people who come out of emergency~     after consultation do not clearly understand the instructions and only 20% are aware of their~     lack of understanding. Waisman et al. Documented that 25% of patients did not understand~     their diagnosis and that 13% to 18% did not understand treatment instructions. Heng et al.~     Have shown that patients leaving after head trauma are unable to cite the symptoms that~     should prompt them to consult quickly.~      The involvement of healthcare teams to inform patients with the help of different~     communication media is therefore particularly important in trying to improve understanding~     and adherence to exit instructions. However, Zavala et al. Point to the fact that this is not~     necessarily sufficient.~      Some authors have identified factors of poor adherence: multiple chronic diseases, multiple~     drug treatments, psychiatric disorders, but also age, social isolation, depression, quality~     of life and socio-economic and cultural level , A low level of health literacy, or planned~     medical follow-up, the severity of the pathology and the perception of that severity by the~     patient, or the patient's dissatisfaction with medical instructions.~      The patients' adherence to the literature is evaluated in a varied manner according to the~     pathologies concerned: counting the number of tablets; Patient self-tracking log; Reports~     from physicians, reports by third parties (such as the patient's spouse); Electronic~     measurements (for example, metered-dose inhalers or electronic drop dispensers); Blood or~     urine dosage. The different methods used have advantages and disadvantages that need to be~     assessed according to the needs of the study we wish to implement. While declarative~     investigations in the assessment of patient adherence are criticized, no method has~     unfortunately been used as a benchmark for assessing adherence. The bibliographic search did~     not find any questionnaires that had been validated in this context. In order to evaluate the~     adhesion, the investigator will therefore opt for a semi-directed interview at D7 in order to~     better control a possible bias of memorization. This tool has known limitations including a~     tendency to overestimate adhesion, because patients tend to respond to what doctors want to~     hear. This will be taken into account in the interpretation of the results.~   "
34333|NCT03117166|"~     The use of lidocaine, as an anesthetic drug, during implantation of an implantable~     cardioverter-defibrillator(ICD)will not result in a clinically significant alteration of the~     defibrillation threshold during ICD placement.~   "
34334|NCT03117153|"~     The aim of the present clinical study is to evaluate the efficacy and safety of the novel~     toothpaste in patients diagnosed with gingivitis and/or periodontitis.~   "
34335|NCT03117140|"~     This is a prospective randomized controlled triple-masked study looking at the duration of~     nerve block analgesia when using the listed adjuvants (dexamethasone, buprenorphine and~     clonidine) plus ropivacaine versus plain ropivacaine alone.~   "
34336|NCT03117127|"~     In crossover trials, ten (N=10) young men (18-35 y) will receive stable isotope tracer~     infusions and perform a single bout of resistance exercise. Immediately after resistance~     exercise, participants will ingest stable isotope labeled whole eggs (18 g protein, 17 g fat)~     or egg whites (18 g protein, 0 g fat) cooked in scrambled form. Repeated blood and muscle~     biopsies will be collected to determine whole body amino acid kinetics, muscle amino acid~     transporters, anabolic signaling and myofibrillar protein synthesis rates during the trials.~   "
34337|NCT03117114|"~     Adenomas are premalignant polyps of the colon that should be resected endoscopically.~     Complete resection of adenomatous polyps is the major task of colonoscopy. In some cases~     polyp may be poorly accessible making endoscopic resection difficult. Polypectomy may be~     conducted using the so-called piece meal technique in these cases. However, leaving polyp~     residual polyps in the colon bears the risk of malignant degeneration as colorectal cancer~     may arise form adenomatous remnants. In case of difficult polyp locations endoscopic~     resection may also be time consuming. On the other hand endoscopists are facing an increased~     time pressure due to rising numbers of procedures during the last decades.~      The Endocuff Vision device (EVD) is a cap that can be mounted to the tip of a standard~     endoscope. The EVD has small flexible branches on its outside. The branches turn out during~     withdrawal. By that the branches are getting in contact with colonic wall. This mechanism~     leads to a more stabilized position of the colonoscope in the bowel. It is hypothesized that~     resection circumstances may be improved by using an EVD. In addition, stabilizing the scope~     during resection may result in a reduced time effort. Until now no controlled trials exist~     investigating the effect of EVD on the time effect during polyp resection. Therefore a~     randomized controlled trial needed comparing standard polypectomy versus polypectomy using~     the EVD during routine colonoscopy procedures.~   "
34338|NCT03117101|"~     This was a monocentric, open label, non-randomised, non-comparative, dose-finding phase I~     study~   "
34353|NCT03116906|"~     The primary objective of this trial is to investigate the safety and tolerability of BI~     685509 in healthy male subjects following oral administration of multiple rising doses.~      Secondary objectives are the exploration of the pharmacokinetics (PK), dose proportionality,~     the attainment of steady state, as well as investigation of linearity and pharmacodynamics~     (PD) of BI 685509 after multiple dosing.~   "
35194|NCT03105921|"~     The aim of the study is to evaluate the use of irreversible electroporation in the treatment~     of locally advanced cancers of the head of pancreas with vascular spread. This technique~     would allow to treat the unresectable part of the tumor to make it more accessible for a~     secondary surgery.~   "
34339|NCT03117088|"~     Study Title Safe- SCOPE Pilot Study Standardized Checklist of Patient Information Exchange~      Short Title Safe- SCOPE Pilot Study~      Study Design: Single centre two armed cluster randomised crossover pilot study~      Study duration: 5 months~      Objectives:~        -  Influence of standardised checklists on medical/ physician handovers on an Intensive~          Care Unit -ICU and its influence on patient safety~        -  Satisfaction survey in physicians group~      Number of patients:~      All patients treated on OIM during assessment period~      Checklist Intervention~        -  All physicians working in the department of Intensive Care Medicine and Intermediate~          Care are informed and enlightened about Safe-SCOPE Pilot Study. After written consent~          participating physicians will use an online form ISBAR3 Checklist or alternative~          Checklist for handovers twice a day.~        -  Handover times/schedule:~      OIM 1,2,3,5, und 6: 7:30 am and 7:30 pm OIM 4 und WEA 1: 7:30 am and 2:00 pm~        -  ISBAR3 Checklist~        -  VICUR Checklist wash- out Phase:~        -  No checklists for one month~      Efficacy:~      Patients:~        -  Mortality rate~        -  Duration on ICU~        -  Reuptake on ICU~        -  SOFA Score on admission to ICU, 48h, 72h and 120h after admission~        -  Handover duration per patient~        -  Number of enclosed patients~      Handover:~        -  Entire handover duration~        -  Interruptions during handover~   "
34340|NCT03117075|"~     To compare the pain scales between clinician evaluated and reported with wearable device by~     patients.~   "
34341|NCT03117062|"~     The purpose of this randomized clinical study was to evaluate the impact of occlusal~     reduction on the incidences of post-instrumentation and post-obturation pain. Forty four~     patients were included in this study. Inclusion criteria were posterior mandibular teeth~     having symptomatic irreversible pulpitis and symptomatic apical periodontitis. Patients were~     randomized into two equal groups. In the intervention group the functional and nonfunctional~     cusps were reduced until absence of contact was confirmed, while in the control group the~     occlusal surfaces were left intact. Standard endodontic treatment was performed in two visits~     using rotary nickel titanium files for shaping, 2.5% sodium hypochlorite for cleaning and~     lateral condensation technique with resin sealer for obturation. Pain was assessed~     preoperatively, then after 6, 12, 24 and 48 hours following instrumentation, then after 6 and~     12 hours following obturation. Visual Analogue Scale (VAS) was used as the primary outcome~     measure. Patients were given a placebo to be administrated in case of severe pain and~     ibuprofen 400mg was prescribed in case of persistent pain.~   "
34342|NCT03117049|"~     The purpose of study is to compare the efficacy and safety of ONO-4538 in combination with~     carboplatin, paclitaxel, and bevacizumab (ONO-4538 group) to placebo in combination with~     carboplatin, paclitaxel, and bevacizumab (placebo group) in chemotherapy-naïve subjects with~     stage IIIB/IV or recurrent non-squamous non-small cell lung cancer unsuitable for radical~     radiation in a multicenter, randomized, double-blind study.~   "
34343|NCT03117036|"~     This prospective study enrolls patients who are diagnosed with aggressive lymphoma including~     Hodgkin and non-Hodgkin lymphomas. Enrolled patients will be treated according to our~     institution' treatment policy in clinical practice. The disease status including response to~     therapy and survival status will be regularly updated during the study period. Patients'~     serum and cell-free DNA will be collected and analyzed.~   "
34344|NCT03117023|"~     The purpose of this study is to find out the effect of Dexmedetomidine for treatment of sleep~     deprivation, pain relief and postoperative recovery on middle-aged and elderly Patients with~     Gastric Cancer.~   "
34345|NCT03117010|"~     This prospective study enrolls subjects who have clinical and laboratory manifestations~     related with hemophagocytic lymphohistiocytosis. The purpose of the study is to evaluate~     clinical and biological features of adult hemophagocytic lymphohistiocytosis. The enrolled~     subjects into this study will be evaluated according to the HLH (hemophagocytic~     lymphohistiocytosis)criteria and treated with systemic immunosuppressive therapy or~     chemotherapy. All subjects will be regularly monitored by physicians participating in this~     study.~   "
34346|NCT03116997|"~     The purpose of this study is to compare two different medications (neostigmine/glycopyrrolate~     and sugammadex) to see if one drug improves patient comfort regarding the return of muscle~     strength after surgery.~   "
34347|NCT03116984|"~     This clinical trial is a prospective, randomized, controlled and multicenter study.And the~     trial is going to enroll better control intrahepatic tumors for hepatocellular carcinoma(HCC)~     patients who meet the inclusion criterion.The patients were divided into two groups, the~     group A by TACE and the other group B by external- beam radiotherapy(EBRT) after 2 times~     TACE. Then the therapeutic effects and toxicities of TACE and EBRT are evaluated during the~     follow-up period. The study design plans to enroll 300 patients, and each group includes 150~     cases.~   "
34348|NCT03116971|"~     M3814 is an investigational drug under evaluation for treatment of lung cancer. The purpose~     of the study is to assess the Safety and Efficacy of M3814 in combination with chemotherapy~     with SCLC ED.~   "
34349|NCT03116958|"~     The purpose of this study is to improve CPAP treatment compliance of Obstructive Sleep Apnea~     Syndrome using an integrated telemedicine platform (MyOSA system)~   "
34350|NCT03116945|"~     The aim of the present study is to validate the uptake of novel, positron emitting~     radiotracer, 68Gallium Citrate in hepatocellular carcinoma(HCC). The investigators also aim~     to evaluate the sensitivity of 68Gallium (68Ga)-citrate positron emission tomography/computed~     tomography (PET/CT) for the identification of intrahepatic HCC lesions in comparison with~     existing modalities: computed tomography (CT) alone and magnetic resonance imaging (MRI). The~     investigators expect that 68Ga-citrate PET/CT will offer a sensitive functional imaging~     modality for identification of HCC lesions in the liver. The investigators intend to use the~     results of this preliminary study to fuel further studies in the utility of 68Ga-citrate~     PET/CT for HCC treatment monitoring.~   "
34351|NCT03116932|"~     The target population for this project will be men-who-have-sex-with-men (MSM) at high risk~     of HIV acquisition~   "
34354|NCT03116893|"~     The primary objective of this trial is to investigate the relative bioavailability of BI~     685509 given alone under fasted conditions (Reference, R) compared to the intake after a high~     fat, high caloric breakfast (Test 1, T1), to combined administration with itraconazole under~     fasted conditions (Test 2, T2) and to combined administration with rifampin under fasted~     conditions (Test 3, T3).~      The secondary objective is the evaluation and comparison of several pharmacokinetic~     parameters between the treatments.~   "
34355|NCT03116880|"~     Fluoroscopy is traditionally used for guidance of endovascular aortic repair (EVAR). In order~     to minimize exposure to radiation and nephrotoxic contrast medium, it is possible to generate~     a navigation road map by registering the intraoperative images with preoperative computed~     tomography angiograph (CTA). In modern hybrid operating rooms, several commercial solutions~     for this exists today (e.g. Siemens Syngo iPilot, Phillips Vesselnavigator). In order to~     register (fuse) the preoperative and intraoperative imaging to each other, a registration~     algorithm has to be applied. Sufficient accuracy of this algorithm is crucial, for if it~     fails the road map cannot be used for intraoperative navigation. The purpose of this study is~     therefore to evaluate two different 3D registration algorithms with regard to registration~     accuracy.~   "
34356|NCT03116867|"~     Sonosalpingography is done to assess the efficacy of hysteroscopic tubal occlusion by roller~     ball electrode.~   "
34357|NCT03116854|"~     Beta Blocker therapy is a mainstay of treatment following acute coronary syndromes (ACS),~     particularly acute myocardial infarction (MI). Studies have repeatedly demonstrated the~     benefit of Beta blocker therapy following either ST-segment elevation myocardial infarction~     (STEMI) or non-ST-segment elevation ACS,and Beta blocker therapy has been a performance~     measure used to grade hospital performance by the Centers for Medicare and Medicaid Services~     and Joint Commission on Accreditation of Healthcare Organizations.Although the benefit of~     Beta blocker therapy has been clearly demonstrated, the doses that have been used in many of~     these studies are significantly higher than those typically used currently in clinical~     practice.The benefit of Beta blockers has been ascribed to dose-related heart rate~     reduction,although alternative mechanisms for their benefit have also been proposed.In~     addition, the classical Beta blocker trials were performed decades ago, before the modern~     therapeutic era,which includes reperfusion therapy, potent antithrombotics, and statins. This~     raises the question of whether titration of Beta blocker therapy to the high doses that had~     been previously studied provides substantial incremental benefit in current clinical practice~     over the more frequently prescribed and clinically tolerated doses of Beta blockers.Moreover,~     a recent study has reported that high-dose Beta blockers were not superior to low-dose Beta~     blockers,aprovocative finding requiring validation. And until now, there has been no registry~     on patients with ACS about Between Beta-blocker Treatment in Henan, the most populated (about~     100 million) and predominantly rural (66%)province in central China.~      This multicenter, prospective, observational study is aimed to analyze the application status~     and long-term prognostic beneﬁt of beta-blockers in patients with acute coronary syndrome.~   "
34358|NCT03116841|"~     The purpose of this study is to exploratorily evaluate the effect of vonoprazan 20 mg on~     sleep disturbance of patients with reflux esophagitis, who have heartburn and/or~     regurgitation and ≥ 6.0 in the Pittsburgh Sleep Quality Index (PSQI) global score despite the~     maintenance treatment with PPI other than vonoprazan.~   "
34359|NCT03116828|"~     A study of a drug to be used in addition with another drug to treat adults with Uncontrolled~     Partial-onset Seizures~   "
34360|NCT03116815|"~     Control of hypertension remains one of the most important interventions available to~     clinicians to reduce risk of cardiovascular disease, kidney disease and stroke. Self-measured~     home blood pressure monitoring plus additional support has been shown to reduce blood~     pressure in adults with previously uncontrolled hypertension. Most previous studies have~     utilized healthcare personnel to facilitate communication of home blood pressure levels to~     physicians and did not provide methods to directly transmit self-measured blood home blood~     pressure levels to physicians via the electronic health record. Emerging technology now~     provides the ability for patient's to upload self-measured blood pressure levels into their~     own medical record which may eliminate the need for additional health personnel. This study~     will examine the feasibility, patient adherence and physician and patient perceptions of a~     web-based application which will facilitate direct input of self-measured home blood pressure~     levels and patient reported symptoms directly into the electronic health record with message~     alerts to the provider for hypertension management. Up to 10 Loyola primary care physicians~     and 20 of their respective patients age 50 years and older who have a smart phone device or~     home computer and have treated hypertension will be enrolled. The study will utilize the~     existing web-application called MyChart. MyChart is the name of the web-based application and~     it is not an acronym. Enrolled patients will download the existing MyChart web-based~     application on their smart phone device or home computer and will record home blood pressure~     measurements using their home blood pressure machine into their smart phone application. The~     MyChart application is available to all patients receiving care in the Loyola Health Care~     System. The blood pressure readings and patient reported symptoms will then be available for~     their physicians to review within the electronic health record. After using the web-based~     application for two months, both patients and physicians will be asked to participate in~     focus groups and interviews, respectively, to determine their perceptions and satisfaction~     with the web-based application. Data from this feasibility study may be used to guide a~     future clinical trial of hypertension management that examines the effectiveness of the~     MyChart web-based application for frequent blood pressure monitoring compared to standard~     care.~   "
34361|NCT03116802|"~     Since the 1st pandemic of the 21st century caused by SARS coronavirus, the world has~     experienced outbreaks of swine origin H1N1 influenza, Ebola and Zika viruses, which have all~     resulted in global health crises. Rapid mass vaccination with an effective vaccine such as a~     live attenuated vaccine, of vulnerable immune-naïve populations to establish herd immunity is~     an approach to control outbreaks. Such live attenuated vaccine had been used with great~     success in sporadic yellow fever outbreaks and recently successfully employed in Ebola field~     trial, both of these diseases have the potential for pandemic spread. Indeed, live attenuated~     vaccines have proven especially effective in controlling childhood diseases and have even~     succeeded in eradicating polio and measles from most parts of the world. However, deployment~     of such vaccines for pandemic control cannot be limited to children but must include adults~     in order to rapidly elevate herd immunity rates to halt transmission. Vaccinating adults may~     produce efficacy rates significantly different to those observed in children due to the~     prevalence of chronic diseases and their associated metabolic complications. Presently, there~     are 1 billion people who are overweight, many suffer from concurrent metabolic disorders. As~     activation of the adaptive immunity is reliant on a robust innate immune response to~     vaccines, metabolic disorders and long-term anti-inflammatory therapy with interventions such~     as statins may reduce vaccine immunogenicity resulting in suboptimal efficacy in this~     subpopulation. This study would therefore test the hypothesis that statins reduce live~     attenuated vaccine immunogenicity. We will combine a clinical trial with systems vaccinology~     approaches to define the impact statins has on the innate immune, B and T-cell responses to~     live attenuated vaccination. Our study will thus extend upon another recently completed trial~     by us and will provide new insights into the determinants of vaccine efficacy in a rapidly~     growing and aging population globally~   "
34362|NCT03116789|"~     The purpose of this study is to analyze the ameliorative effects of oral probiotics on~     bacterial vaginosis.~   "
34363|NCT03116776|"~     This trial is designed to evaluate the efficacy of walnut shell glasses moxibustion for dry~     eye syndrome compared with sodium hyaluronate eye drops.~   "
34364|NCT03116763|"~     The iPeer2Peer program matches teens with arthritis to an older mentor who has learned to~     manage their arthritis well and can support them emotionally and socially. This study will~     compare two groups of teens: those who are in the iPeer2Peer Program and those in the control~     group (no mentor).~   "
34365|NCT03116750|"~     The ASPIREX®S Endovascular System is a rotating and aspirating catheter system. It is~     intended to be used for the percutaneous transluminal removal of fresh thrombotic or~     thromboembolic material from native blood vessels (or vessels fitted with stents, stent~     grafts or native or artificial bypasses) outside the cardiopulmonary, coronary and cerebral~     circulations.~      CAPTUREX® , a catheter with a filter basket, is intended to be used for the filtering of~     emboli from blood vessels during potentially embolizing procedures on the patient.~      ASPIREX®S and CAPTUREX® are CE-marked (Class III) medical devices. In this study the~     effectiveness and safety in the removal of thrombi in veins is assessed under real life~     setting.~   "
34366|NCT03116737|"~     The Phase III study is designed to assess the safety, tolerability, and efficacy of Topical~     Benzocaine in children, ages 5 to 12 years, presenting with Acute Otitis Media-associated ear~     pain.~   "
34372|NCT03116659|"~     Cutaneous lymphomas are rare cancers of lymphocytes (white blood cells) that involve the~     skin. Mycosis Fungoides (MF) is the most common type of Cutaneous T-cell lymphoma (CTCL) that~     typically presents with red, scaly patches that often mimic eczema or chronic dermatitis. The~     incidence of MF is about 1/100,000. Skin lesions tend to appear before the diagnosis of CTCL~     is made by several years. Early skin lesions may look like any dermatitis, eczema, or~     psoriasis, leading to delays in the diagnosis.~      Inflammation secondary to bacterial infection is thought to contribute to the T-cell~     proliferation in this type of cutaneous T-cell lymphoma. Antibiotic use for other purposes~     has shown to reduce the inflammation and size of lesions in CTCL patients. There has been~     limited studies with the use of antibiotics as direct treatment for this cancer.~      Host immunity is important in decreasing cancer development and progression. Imiquimod is a~     molecule that stimulates host immunity to reduce the progression of CTCL. There is strong~     evidence of clinical efficacy such that the National Comprehensive Cancer Network (NCCN)~     guidelines recommend Imiquimod for CTCL. Imiquimod is available in generic form, making it~     unlikely to be registered specifically for CTCL, despite its efficacy.~      Additionally, imiquimod is considered a first line treatment according to National~     Comprehensive Cancer Network (NCCN) guidelines for the treatment of Mycosis Fungoides.~      There are currently no studies that have been published that address treating CTCL patients~     with a combined approach of 1) decreasing inflammation caused by bacterial with antibiotics,~     and 2) enhancing the host immune system to destroy cancer cells. Our theory is if we treat~     patient with 14days of antibiotics and 30 days of Imiquimod there will be significant~     reduction in skin lesions.~   "
34373|NCT03116646|"~     The family has a primary prescription in the identification of the chewing disorder in~     children to plan appropriate rehabilitation program and implementation of the training.~     Therefore, it is very important to investigate the validity and reliability of classification~     systems that can be applied by parents. The purpose of this study is to determine the~     validity and reliability of the reliability and validity of family report chewing evaluation.~   "
34374|NCT03116633|"~     This study aims to look at a comparison of liquid biopsy (blood sample) analysis compared~     with tissue biopsy in patients with advanced lung cancer~   "
34375|NCT03116620|"~     We aimed to evaluate chewing function (CF) in children with neuromuscular disorders, and~     investigate reliability of the Karaduman Chewing Performance Scale (KCPS).~   "
34376|NCT03116607|"~     A randomized clinical trial with two parallel groups (control and intervened) in the~     Emergency Department (ED) at the Clinical Hospital of the University of Chile will take~     place. The sample will be of 996 patients (498 per group).~      The control group will receive hospital care and discharge plan usual, while the intervention~     group also receive a Program of Pharmaceutical Interventions while in the service and at~     discharge, which includes an analysis of the therapy recommended by the physician, assessing~     the safer alternatives for the patient population and the special conditions of their~     pathology, emphasizing evaluations of effectiveness, safety and tolerability of medication,~     drug interactions, potential adverse events, dose adjustments as needed according to the~     patient's condition ; verification that the administration is optimal, including choosing the~     best route to this and the time when the drugs are infused into the patient.Interventions~     aimed at patient occur during the stay and at discharge, focusing on clarifying~     administration regimens, reasons for using drugs, prevent drug-related problems, clarify~     doubts and educate about pharmacotherapy and make a reinforcement of adherence.~      The selection and patient recruitment will take place during the first hour of admission to~     care box, where they were invited to participate and signed informed consent.~      In both groups, a doctor and a pharmacist, blind to treatment assignment, will gather~     information during the stay, discharge and post-discharge, the latter by telephone 30 days~     after discharge from the ED, in this second interview also verify the existence of a~     readmission and / or unscheduled medical consultation. In addition, discharge of each patient~     satisfaction was measured with respect to the service received by a user satisfaction survey~     applied by external and impartial staff. In addition, two independent trained evaluators~     (Emergency Medical and Pharmaceutical Chemistry), blinded to treatment assignment, evaluate~     the background of each case and by consensus allocated the presence of problems related to~     drugs, and classified as preventable or not preventable, according severity.~      X2 test or Fisher exact test was used to test the hypothesis that the Programme of~     Pharmaceutical Interventions decreases at least 30% the user dissatisfaction compared with~     usual care in the ED.~   "
34377|NCT03116594|"~     This study assesses non-inferiority by comparing GMR(Geometric Mean Ratio) of NBP608 to~     Zostavax which are evaluated by gpELISA (Glycoprotein Enzyme Linked Immunosorbent Assay).~     Total of 646 healthy subjects aged 50 and over are enrolled, and each subject is administered~     with single dose of vaccine which is randomly assigned.~   "
34378|NCT03116581|"~     The study aimed to understand how payoffs for others influence perceptual decision making.~     The research consists in testing how varying monetary payoffs for another modify the~     perceptual decision making processes. The use of drift diffusion models on a random dots task~     enable the characterization of the decision parameter(s) that are modulated when a decision~     is made to win payoffs for others as compared to decisions for self-benefits. Once the~     parameter revealed through behavioral experiment, neuroimaging is applied to find the neural~     correlates of the effects of taking others into account in the decision making process.~   "
34379|NCT03116568|"~     Inflammatory bowel diseases (IBD), Crohn's disease (CD) and ulcerative colitis (UC), are~     caused by the loss of mucosal tolerance towards the commensal microbiota resulting in~     inflammatory responses.~      Identifying intestinal bacteria in mother and newborn of both IBD and Control groups allow us~     to understand the change of bacterial composition human microbiome in the gut during~     pregnancy and childhood development.~   "
34380|NCT03116555|"~     After failure of first-line therapy, single agent of irinotecan is used as second line~     treatment in locally advanced or metastatic gastric or gastroesophageal junctional~     adenocarcinoma. The purpose of this study is to evaluate it there will be more benefit with~     irinotecan plus apatinib.~   "
34381|NCT03116542|"~     The main purpose of this project is to study the uptake pattern of FLT-PET in cases, and it~     is value in assessing the malignant hematopoiesis in cases of Pre-PMF and ET, regarding~     diagnosis, staging and monitoring response to therapy. Identifying different patterns of~     uptake in patients with Pre-PMF and ET in various clinical settings.~      Evaluating FLT-PET as a novel non-invasive technique in cases with Pre-PMF and ET, in~     comparison to the standard bone marrow biopsy about disease diagnosis, assessment of disease~     activity, detection of transformation, monitoring of treatment response and grading of~     fibrosis.Study the ability of FLT-PET to differentiate between Pre-PMF and ET.~      the investigators also aim to examine the association of FLT-PET uptake patterns with~     different genetic makeup (JAK2 (Janus kinase 2), CALR (Calreticulin), MPL (myeloproliferative~     leukemia protein), or Triple negative disease) or allele burden in cases of Pre-PMF and ET.~   "
35208|NCT03105739|"~     The purpose of this prospective, randomized study was to compare the incidence of adverse~     events associated with removal of the LMA either in deeply anesthetised or awake patients.~   "
34382|NCT03116529|"~     Chemotherapy is controversial for soft tissue sarcoma that has not yet metastasized. Surgery~     and radiation are effective for local control, but there are no highly effective~     interventions to prevent metastatic spread of soft tissue sarcoma. Immunotherapy has shown~     promise in other types of cancer. Combining two types of immunotherapy agents with~     preoperative radiation may help the immune system recognize the sarcoma and stimulate an~     anti-tumor immune response.~   "
34383|NCT03116516|"~     This is a phase 1, open label, single-dose, crossover study to investigate the~     pharmacokinetics of YHP1604 in comparison to the co-administration of telmisartan/amlodipine~     and rosuvastatin in healthy male volunteers~      Hypothesis: YHP1604 and telmisartan/amlodipine and rosuvastatin are showing equal~     pharmacokinetics.~   "
34384|NCT03116503|"~     The purpose of the study is to describe the number of diagnosis of bipolar depression and~     comorbid suicidal behavior according to the diagnostic criteria of the DSM-5.~   "
34385|NCT03116490|"~     The aim of this study is to figure out whether anesthesia type have an influence on the~     prognosis of hip fracture surgery.30-day mortality and morbidity after the surgery are our~     main observational index,and according to literature and our experience,regional anesthesia~     may have a better prognosis after hip fracture surgery compared with general anesthesia.~   "
34386|NCT03116464|"~     Dementia impacts Veterans, their families, and other Veterans who serve as caregivers. One of~     the most stressful aspects of caregiving is the management of behavioral problems (e.g.~     wandering, agitation, and sleep difficulties), which exacerbate health issues for both~     caregivers and persons with dementia (PWD). Existing VA caregiver treatments for caregiver~     stress and behavioral problems are often ineffective. Many caregivers do not realize their~     interactions with PWD contribute to behavioral problems and thus do not ask for help to~     improve their interpersonal skills. The aim of this project is to develop an assessment of~     interpersonal skills deficits and a related treatment strategy to assist family caregivers of~     PWD who are challenged by a lack of interpersonal skills and are not helped by existing~     family caregiver treatments. This project, will develop and test (1) a video assessment of~     caregiver/PWD interaction that clinicians will use to identify interpersonal difficulties and~     (2) a family therapy for the interpersonal difficulties clinicians identify in the~     assessment.~   "
34387|NCT03116451|"~     This study supports and promotes work well-being of nursing personnel from the perspective of~     foot health in health care organizations. Half of the participants will receive an electronic~     foot health education program to improve their foot self-care knowledge, while the other will~     receive anything. The outcomes of this project include recommendations and tested educational~     program to occupational health care for improving foot health of nurses.~   "
34388|NCT03116438|"~     The purpose of the study is to evaluate the safety and performance of the CADence device by~     comparing it to the results obtained from standard coronary angiography. The CADence device~     collects acoustic (sound) data from locations on the chest for the purpose of identifying~     coronary artery turbulence, which may be indicative of coronary artery disease.~   "
34389|NCT03116425|"~     Investigators hypothesize that personalizing rTMS targets using functional MRI will allow to~     improve symptoms of patients suffering from chronic catatonia.~   "
34390|NCT03116412|"~     It is not known whether radiological assessments during follow up after surgery for high risk~     melanoma improve survival. Since radiological examinations are resource demanding, could~     inflict worry and cause irradiation exposure it is an important question to address. With the~     introduction of effective medical treatments for malignant melanoma patients, there is a~     tendency to introduce radiological assessments despite the lack of evidence.~   "
34391|NCT03116399|"~     The focus of the study is to evaluate the expanded version of PRISM 1.0 for a broad array of~     seniors with different needs and circumstances. The aims of the study are to: 1) obtain~     information on perceptions of the usefulness and usability of PRISM 2.0 and interface design~     issues; 2) examine the impact of access to PRISM 2.0 on social connectivity, engagement,~     social support, and perceived loneliness; 3) examine the impact of access to PRISM 2.0 on~     perceived isolation, well-being, and quality of life; 4) examine the impact of access PRISM~     2.0 on computer attitudes, self-efficacy, technology proficiency and technology uptake; 5)~     gather data on usefulness of system features and if these vary by living condition; and 6)~     examine, in our statistical models, the influence of factors such as age, cognitive~     abilities, ethnicity, education on system use and outcomes.~   "
34392|NCT03116386|"~     In the context of reduce staff for supervision of dependent elderly, automated risk alert~     systems could have a positive impact on the organization of night care by better targeting~     monitoring. Residents' sleep could be less affected with use of automatic alert system than~     by systematic monitoring visits. One study shows an improvement in the humor of residents~     after the use of such a system.~      The hypothesis of the study is that the use of a bed-raising detection system linked with the~     activation of a lighting environment and a caregivers alert system (Etolya-F® gerontechnology~     device, Anaxi Technology Company) would reduce intervention time in this population, thus~     limiting the time spent on floor and its physical and psychological consequences.~   "
34393|NCT03116373|"~     This study evaluate the secondary shifting of the tracheal tube when the head is moved under~     general anaesthesia. Two sites of fixation (the maxilla and the mandible) are tested in a~     prospective, double blind, randomized and crossover designed study.~      The study test the hypothesis that taping the tracheal tube on the mandible better prevents a~     secondary tube move.~   "
34406|NCT03116204|"~     A person's dependency is defined as the total or partial inability to perform without helps~     the necessary activities of daily life due to activity limitations in the usual environment.~     The consequence is a restriction of participation. In physical and Rehabilitation Medicine~     (PRM), dependency impacts the healthcare team activity at several levels: patient's referral~     and care plan, conditions of home return and resumption of course of life, burden of care~     assessment and care teams management...~      The main goal of this project is the validation of a score assessing physical and cognitive~     activities of patients in follow-up care and rehabilitation (FRC) departments based on the~     ICF model (International Classification of Functioning, Disability and Health) : the SOFMER~     Activity Scale (SAS).~      We want to propose a French generic scale allowing quantifying precisely the dependence and~     burden of care of patients in FRC departments. This scale needs to be valid, easy to apply,~     easy to learn, reproducible, sensitive to change and common to adult subjects, children and~     elderly.~   "
34394|NCT03116360|"~     Hypothesis: Diagnostic ultrasound is an appropriate screening test for acute stress fracture~     in the lower extremity and is superior to x-ray.~      Primary Aims: To determine if diagnostic ultrasound is an appropriate screening test with~     high sensitivity and at least moderate specificity for the identification of acute stress~     fractures of the lower extremity.~      Methods: In this double-blind, prospective clinical study, subjects (age 14 years and up)~     suspected to have an acute stress fracture of the lower extremity will be recruited from the~     Sports Medicine clinic at the University of Virginia Health System in the Department of~     Physical Medicine & Rehabilitation. Subjects will undergo the traditional diagnostic~     algorithm including screening x-ray as part of standard care. Subjects will then undergo a~     confirmatory MRI of the region of concern if the initial x-ray was negative as part of~     standard care. Any subject who does not require an MRI for clinical purposes (initial X-ray~     was positive) will have one completed for research purposes. All subjects will also undergo~     diagnostic ultrasound performed by a separate, blinded physician competent in diagnostic~     ultrasound for research purposes. A statistician in the Department of Public Health at the~     University of Virginia will be performing statistical analysis during data analysis. Findings~     will be analyzed using a McNemar chi-square test to evaluate for significant differences~     between the sensitivities of ultrasound and x-ray.~   "
34395|NCT03116347|"~     The purpose of the study is to acquire additional data on safety, tolerability and~     immunogenicity of HyQvia in pediatric (age two to <18 years) patients with Primary~     Immunodeficiency Diseases (PIDD)~   "
34396|NCT03116334|"~     In this study the investigators will interrogate an existing data set to examine whether~     genetic variants contribute to an inverse association between weight status and cognitive~     function. Investigators hypothesize that body mass index (BMI) will be inversely related to a~     number of variables measuring cognitive function, and that that this inverse relation will be~     at least partially attributable to genetic variants which influence both BMI and cognition.~   "
34397|NCT03116321|"~     The purpose of this study is to determine whether the test product, eslicarbazepine acetate~     800 mg tablets (test 1, To be marketed (TBM) Treatment A), and the reference product,~     eslicarbazepine acetate 800 mg tablets (current Active pharmaceutical ingredient (API) source~     - Marketed formulation (MF)) (Reference, Treatment C), are bioequivalent and to demonstrate~     dose equivalence between eslicarbazepine acetate 4 x 200 mg tablets (test 2, TBM Treatment B)~     and eslicarbazepine acetate 800 mg tablet (Reference).~   "
34398|NCT03116308|"~     The purpose of this study is to investigate the effect of food on the~     catechol-O-Methyltransferase (COMT) activity after repeated doses of opicapone (OPC,~     development code BIA 9-1067) in healthy subjects and to characterize the effects of food on~     the pharmacokinetics (PK) and tolerability of OPC after repeated doses.~   "
34399|NCT03116295|"~     The purpose of this study is to evaluate the bioavailability and the bioequivalence between~     two active pharmaceutical ingredient (API) sources of opicapone (OPC) at two different dosage~     strengths (25 mg and 50 mg) after a single oral dose administration under fasting conditions~     in healthy male and female subjects.~   "
34400|NCT03116282|"~     The study evaluates whether the introduction of e-alcohol therapy (alcohol therapy delivered~     via video conference) can break with some of the barriers related to alcohol treatment and~     thereby appeal to people with a problematic alcohol use (Alcohol Use Disorder Test score ≥~     8). The study aims to evaluate the effect of e-alcohol therapy on initiation, treatment~     compliance and alcohol intake as compared to treatment as usual .~   "
34401|NCT03116269|"~     Patients presenting with acute cerebral ischemic events are randomly assigned into aspirin~     (n=40) or cilostazol (n=40) group in a double-blinded manner. FMD is measured as a primary~     outcome at baseline (T0) and 90 days (T1). Serious and non-serious adverse events were~     described.~   "
34402|NCT03116256|"~     The aims of this project are: to investigate the impact of VLCD on control of muscle protein~     synthesis, muscle structure and function, cardiac function (ejection fraction), vascular~     function (blood flow and capillary function), overall physiology status (cardiopulmonary~     function) and metabolic status (insulin sensitivity) in overweight and obese middle-aged male~     with or without exercises.~      There are 3 groups for the study, to which each participant will be randomly assigned into~     one of either:~        1. VLCD only~        2. VLCD with resistance exercise training (RET)~        3. VLCD with high intensity interval training (HIIT) The total duration of the intervention~          is six weeks, with exercises taking place three times per week at the research unit~          under close supervision by trained staff.~   "
34403|NCT03116243|"~     The MSHS Study is a nationally representative study commissioned by the U.S. Office of Health~     and Human Services' Administration for Children and Families that will describe the~     characteristics and experiences of the children and families who enroll in MSHS and the~     practices and services of the MSHS programs that serve them. The MSHS Study draws heavily on~     the Design for MSHS Survey Report (2011) and is informed by the current context of key policy~     and programmatic issues and broader issues impacting the lives of migrant and seasonal~     farmworkers and their families.~      The MSHS Study has two components: a Program/Center component and a Classroom, Family, Child~     component that are based on distinct samples. The first component is off-site and consists of~     mailed surveys that will be sent to the universe of MSHS program directors and a~     representative subset of center directors to provide information on program and center~     operations. The second component consists of onsite data collection - including classroom~     observations, surveys with teachers and assistant teachers, parent interviews, teacher and~     parent child reports, and direct child assessments - with a nationally-representative sample~     of centers, classrooms, families and children.~      Once data are collected, the study will address a set of research questions that can be~     summarized into three broad categories: (1) What are the characteristics of MSHS programs,~     families, and children? (2) What services do MSHS programs provide, what instructional and~     language practices are used, and what is the quality of MSHS classrooms? and (3) What are the~     associations between MSHS characteristics and child/family well-being?~   "
34404|NCT03116230|"~     The objective of this study is complete a longitudinal cross-over clinical study to~     investigate the effect of treatments for knee pathology, including cutaneous stimulation~     (skin vibration and soft knee brace), on locomotion tasks (i.e. walking, jogging, stair~     ascending and descending), muscle function, and pain/function.~   "
34405|NCT03116217|"~     Validate the use of fetal urine peptidome-analysis for the stratification of fetuses with~     Posterior Urethral Valve for post-natal renal function.~   "
34411|NCT03116139|"~     Both, CT scans and VQ scans, are used by doctors to look for pulmonary embolism. The most~     common reason to order a VQ scan is to avoid the IV dye. The IV dye used for CT scans can~     cause kidney problems in some patients, called contrast-induced nephropathy or CIN. This is~     a kidney problem that usually does not make patients feel any differently or change how they~     urinate. Most of the time, it can only be found by testing blood several days later. This~     kind of kidney problem can be very mild and some patients will never have any symptoms,~     rarely these problems can be severe. Some patients can also have similar kidney problems for~     many other reasons (reactions to medications, blood pressure problems, etc.) and can even~     happen in patients that do not get IV dye. That is why doctors are not sure exactly who will~     have these problems or if using a test that does not use IV dye can prevent this kidney~     problem. The VQ scan uses a different medication through the IV that is not IV dye and has~     not been linked to kidney problems. The purpose of this study is to learn if using the test~     that does not use IV dye (the VQ scan) instead of a CT scan in some patients can help to~     prevent kidney problems.~   "
34412|NCT03116126|"~     NorAD is a clinical trial funded by the UK National Institute of Health Research. In this~     trial the investigators will assess whether a long-acting preparation of guanfacine, a drug~     used to treat Attention Deficit Hyperactivity Disorder in children, can improve thinking~     (particularly attention) in Alzheimer's Disease when it is added to the standard~     NICE-approved drugs that are normally used in this condition.~      This is a randomized clinical trial designed to evaluate the efficacy of extended-release~     guanfacine as an add-on therapy in AD, and whether it improves cognition compared to standard~     cholinergic therapy alone.~   "
34413|NCT03116113|"~     A clinical trial of AAV-RPGR retinal gene therapy for patients with X-linked retinitis~     pigmentosa~   "
34414|NCT03116100|"~     Behavioral disorders of psychiatric or neurological origin in the elderly are an emerging~     public health problem. Its management can include a prescription of psychotropic drugs~     (anxiolytics, hypnotics, neuroleptics, antidepressants for the most part). Many studies~     highlight the misuse of psychotropic drugs in this specific and vulnerable population, as~     well as the need for targeted actions.~      As for neuroleptics, there is a deleterious over-prescription in the so-called productive~     behavioral disorders (cries, agitation, aggressiveness, ambulation), in particular in the~     patient with Alzheimer's disease (80% of patients) or related. The same applies to behavioral~     disorders in an acute episode of confusion, which also constitute a situation for the~     prescribing of psychotropic drugs in the elderly. The frailty of the elderly associated with~     neuroleptics is the cause of a significant iatrogenic (falls, confusions, excessive sedation,~     etc.), iatrogeny is largely avoidable.~      There is little data on the representation of behavioral disorders in the elderly, whereas~     the recognition and management of behavioral disorders are functions of the tolerance of the~     entourage and the training of the caregivers. Significant data exist in the literature about~     diagnosis, risk factors, factors favoring or triggering behavioral disorders and somatic~     pathologies to be sought urgently.~      The available recommendations on the drug treatment of behavioral disorders are complex and~     inappropriate in light of new data, including the dangerousness of psychotropic drugs. The~     deleterious effect of long-term drug treatments is proved. There is no validated drug~     strategy, especially in acute confusions of the elderly.~      One study showed that there was a change in the type of neuroleptic prescribed between 2003~     and 2010. Half of the general practitioners studied during this period switched from a~     first-generation neuroleptic to a second-generation neuroleptic. Nevertheless, the type of~     molecule chosen remains at the discretion of the treating physician or even required a~     psychiatric opinion or a passage in the emergencies. In the case where the practitioner~     initiates a prescription in office, in the home or in EHPAD, certain situations require the~     choice of a neuroleptic with or without pre-therapeutic assessment.~   "
34415|NCT03116087|"~     The overall objective of this study is to establish if testosterone replacement in~     post-menopausal women with low testosterone levels and stress urinary incontinence (SUI) will~     lead to improvement in symptoms of SUI.~      This study is a prospective, randomized, double-blind, placebo-controlled, parallel-group,~     clinical trial and will involve sixty (60) post-menopausal women with clinically diagnosed~     stress urinary incontinence and low testosterone concentrations. These subjects will enter~     the control period, which involves the baseline measurements of pelvic floor muscle volume~     and strength, amounts of urine leakage in 24-hour period, urodynamic parameters, and quality~     of life using Incontinence Impact Questionnaire and Urogenital Distress Inventory. Subjects~     are then randomly assigned to either placebo (30 subjects) or 300 mcg/twice-weekly~     testosterone patch (30 subjects) group. Both the subjects and investigators will be blinded.~     The duration of the testosterone/control study will be 36 weeks, with weeks 1-3~     screening/control period, 4-28 application of placebo or testosterone patches and 29-36~     recovery time/assessment of effects.~   "
34416|NCT03116074|"~     The goal of this study is to implement and evaluate an interactive patient-centered discharge~     toolkit (PDTK) to engage patients and care partners in discharge preparation and~     communication with providers after discharge. The aims of this study are to:~        1. To refine and implement an interactive PDTK on a general medicine unit that patient and~          caregivers can use to prepare for discharge and communicate with key providers during~          the transition home.~        2. To evaluate the impact of the PDTK on patient activation (primary outcome). Patient~          reported self-efficacy after discharge; post-discharge healthcare resource utilization;~          and perception of patient-provider communication will be measured as secondary outcomes.~        3. To identify barriers and facilitators of implementation, adoption, and use of the PDTK~          by patients, caregivers, and providers using qualitative and quantitative methods.~   "
34417|NCT03116061|"~     The European General Practitioners Research Network (EGPRN) designed and validated a~     comprehensive definition of multimorbidity using a systematic literature review and~     qualitative research throughout Europe. This definition was tested as a model to assess~     decompensation in multimorbid outpatients.~      The objective is to assess which criteria in the EGPRN concept of multimorbidity could detect~     decompensating outpatients in a primary care cohort at a 6-month follow-up and to assess~     whether a large scale cohort with FPs would be feasible.~   "
34418|NCT03116048|"~     Background and objectives The Pectoral Nerves Block (Pecs) Type II is a regional anesthesia~     technique that provides post-surgical pain relief for patients undergoing breast surgery.~     Post-procedural pain relief is known to diminish persistent pain. In this prospective~     follow-up, the investigators evaluated whether the Pecs II block, compared to placebo, is~     effective in reducing persistent post-procedural pain after breast cancer surgery in female~     patients.~      Patients and methods 140 breast cancer stage 1-3 patients undergoing mastectomy or~     tumorectomy with sentinel node or axillary node dissection under general anesthesia were~     randomized to receive a Pecs block (levobupivacaine 0.25%) or placebo (saline 0.9%). Patients~     were invited between 9 and 31 months after surgery to complete a persistent postsurgical pain~     survey.~   "
35243|NCT03105284|"~     The aim of the study is to evaluate a physiological concentration of adipose tissue-derived~     stem cells (ASC) in excised fat versus fat harvested by liposuction. Participants will act as~     their own control as both extraction methods are performed on each participant.~   "
34419|NCT03116035|"~     This is a prospective randomized control trial to compare the impact of two different types~     of pre-operative web-based breast cancer information on the quality of patient decision~     making. Patients are emailed web-based information prior to the surgical consultation.~     Outcomes are assess at multiple time points: 1) prior to the surgical consultation, 2)~     immediately following the consultation.~   "
34420|NCT03116022|"~     Hypoestrogenism leads to vaginal wall changes resulting in diminished vaginal lubrication~     and, consequently, causing pain during intercourse. Topical estrogen therapy (THT) may~     control this complaint. However, there are limitations on its use, especially in patients~     with breast cancer and diagnosed endometrial cancer. This randomized clinical trial aims to~     assess the impact of local estriol therapy in postmenopausal women complaining of coital pain~     and to assess serum concentrations of estriol in these women after estriol use.~     One-hundred-thirty-two women aged between 40 and 65 years will be randomized into three~     groups: Women using estriol 1 mg / 1g at the proximal third of vagina every other night -~     estriol proximal group (PEG), women in using estriol 1 mg / 1g at the distal third of the~     vagina every other night - estriol distal group (DEG), gel group (GG) using water-based~     during intercourse.~   "
34421|NCT03116009|"~     This will be a randomization of two groups of obese pregnant women into early screening for~     diabetes mellitus at the time of their first or subsequent prenatal visits before 20 weeks of~     gestation versus standard time of screening for diabetes at 24 - 28 weeks as it is done for~     all pregnant women. The perinatal outcomes between the two groups will be compared to~     determine whether early screening for diabetes in all obese pregnant women has a clinical~     merit or significant.~   "
34422|NCT03115996|"~     To evaluate the safety and tolerability of single ascending intravenous (IV) and subcutaneous~     (SC) doses and a multiple dose regimen.~   "
34423|NCT03115983|"~     The LimiFlex™ Clinical Trial is a prospective, concurrently controlled, multi-center study to~     evaluate the safety and effectiveness of decompression and stabilization with the Empirical~     Spine LimiFlex™ Paraspinous Tension Band compared to decompression and transforaminal lumbar~     interbody fusion (TLIF) with concomitant posterolateral fusion (PLF) for the treatment of~     lumbar degenerative spondylolisthesis (Grade I per Meyerding classification) with spinal~     stenosis. Clinical trial sites will enroll solely LimiFlex subjects or solely TLIF/PLF~     subjects.~   "
34424|NCT03115970|"~     Capillary or venous lactate level evaluation in prehospital care could be simple and~     beneficial tool for optimising prehospital care in patients with severe trauma.~   "
34425|NCT03115957|"~     Patients will be randomized to early PN group or late PN group at day 3 after abdominal~     surgery. Patients will receive supplemental parenteral nutrition or not within 7 days after~     abdominal surgery. Both groups will receive SPN except 80% of target energy delivered by EN~     or oral or patients are discharged from hospital. The primary and secondary outcomes will be~     collected.~   "
34426|NCT03115944|"~     A Multi-Center Pilot Study to Assess the Safety and Efficacy of the VShape Ultra UltraSpeed~     Handpiece for Abdomen Circumference Reduction~   "
34427|NCT03115931|"~     It is a study to evaluate the relationship between preoperative nutritional assessment and~     clinical outcomes and to explore the effect of preoperative nutritional support on clinical~     outcomes in patients after abdominal operation.~   "
34428|NCT03115918|"~     The research design is a randomized prospective clinical study comparing the incidence of~     Walled Off Necrosis (WON) in patients with acute necrotizing pancreatitis.~   "
34429|NCT03115905|"~     This is a staged registry study of early treatment strategy management of acute aneurysmal~     subarachnoid hemorrhage(aSAH) among different economic development levels areas in China.~      First stage, the study will investigate and register the basic information of emergency~     treatment management for the acute aSAH in 20 different grade centers located in different~     economic levels districts including Northeast part, Northern, Eastern, South-central,~     Northwest, Southwest and Qinghai-Tibet of China. Comparing the the outcome of acute aSAH to~     find the critical factors to affect it by statistical analysis. Then,the investigators will~     offer some suggestions to adjust the measures to improve the efficacy of emergency medical~     service for acute SAH.~      Second stage, to evaluate the outcome after applying the new suggestion of self-control~     methods.~      The investigators hypothesis that there is an appropriate green pathway in different~     districts to shorten the rescuing time, improve the curative effects.~   "
34430|NCT03115892|"~     The Effect of Mouthwash Containing Green Tea With Aloe Vera and Chlorhexidine Mouthwash on~     Oral Malodour Among a Group of Egyptian Children: Randomized Clinical Trial~   "
34431|NCT03115879|"~     Introduction: Lower extremity weakness associated with musculoskeletal pathology can cause~     activity limitations. Physical therapy intervention in the form of exercise is commonly~     directed at improving muscular performance, however, neuromuscular adaptations may limit the~     effectiveness of traditional strengthening exercises. Manual therapy techniques have been~     used as a disinhibitory intervention to increase muscle activation and strength before~     participating in strengthening exercises or performing functional tasks While there is recent~     evidence to support joint mobilization as a valuable manual therapy disinhibitory~     intervention Currently, there is no evidence to substantiate anecdotal experience that a~     HVLAT hip distraction mobilization improves muscle performance in subjects with lower~     extremity pathology and lower extremity weakness. The purpose of this study was to determine~     if a HVLAT hip distraction mobilization would result in an immediate change of maximal force~     output of the quadriceps, gluteus maximus and gluteus medius.~      Methods: Forty individuals with a lower extremity pathology volunteered for this study.~     Inclusion criteria were having a unilateral musculoskeletal pathology, being greater than 18~     years of age, 10% decrease in muscle strength in symptomatic side compared to healthy side,~     and absence of medical precautions that would prevent a maximal effort strength test and~     exclusion criteria included individuals with a history lower extremity recent muscle or~     tendon ruptures (within the past 6 months) and postoperative knee, hip and ankle surgery.~     Demographic data, including diagnosis from referring physician were collected. All subjects~     completed the Lower extremity function scale (LEFS). A single evaluator blinded to the~     involved extremity was responsible for quadriceps, gluteus medius and maximus strength~     analysis pre and post mobilization of both symptomatic and non-symptomatic sides. The subject~     underwent the HVLAT hip distraction mobilization of the symptomatic side, and an immediate~     re-assessment of strength of both symptomatic and non-symptomatic sides followed the~     mobilization.~   "
34443|NCT03115723|"~     Hospital readmission rate following percutaneous coronary interventions (PCI) or coronary~     angiographies (CAG) is a main indicator of quality of care and addresses economic issues. The~     aim of this study is to quantify the frequency and analyse the types of rehospitalizations~     and repeat revascularizations during one year after a PCI or a CAG. This information is~     needed to organize the health care pathway and to identify preventable rehospitalizations.~   "
35244|NCT03105271|"~     Patients with sickle cell disease may be at risk for acute kidney injury during sickle cell~     crisis (pain or acute chest syndrome). This study will evaluate blood and urine biomarkers of~     kidney injury during an admission for crisis and during well clinic follow-up.~   "
34432|NCT03115866|"~     Rates of obesity and the metabolic syndrome are increasing in the young adult population~     (years 18-28). Modifying diet, especially increasing fruit and vegetable intake, can help~     assist in health maintenance and disease prevention. The purpose of this project is to~     evaluate the impact of the FRUVEDomics behavior intervention on dietary behaviors and~     metabolic parameters on young adults at-risk of disease. FRUVEDomics is an 8-week~     free-living dietary intervention, based on the USDA Dietary Guidelines for Americans and~     driven by the Social Cognitive Theory, conducted in young adults (18-28 years old) at West~     Virginia University. Individuals were recruited if they had pre-existing poor nutritional~     habits. A metabolic syndrome risk screening score was given to participants at baseline to~     measure risk status for chronic disease. Subjects were randomized into one of three~     nutritional intervention groups: 1) FRUVED (50% fruit & vegetable), 2) FRUVED+LRC (50%~     fruit & vegetable plus low refined carbohydrate), and 3) FRUVED+LF (50% fruit & vegetable~     plus low fat). Anthropometrics, surveys, venous blood samples and body composition were~     collected before and after the intervention. Group nutrition education including basic~     nutrition for the prescribed intervention, culinary tool kit distribution, sample budget and~     grocery shopping tips were delivered to each participant group prior to the start of the~     intervention. Participants underwent individual weekly consultations with a Registered~     Dietitian Nutritionist using food logs, food pictures and receipt management, to assess~     adherence and cost of the intervention.~   "
34433|NCT03115853|"~     Aliskiren (also called TekturnaTM) is a new drug for high blood pressure. Aliskiren works by~     blocking the actions of a substance called renin. Renin is a natural substance in the body~     that raises blood pressure. Renin is believed to contribute to the production of blood clots~     by increasing the amount of a substance known as Plasminogen Activator Inhibitor or PAI-1.~     This study will measure how aliskiren changes the amount of PAI-1 in the blood depending on~     the time of dosing. The purpose of this study is to find out if it is better to take~     aliskiren in the morning or at night.~   "
34434|NCT03115840|"~     Millions of older adults are hospitalized for a critical illness each year and although they~     are more likely than ever to survive this illness, they commonly face significant morbidity~     in the form of disabilities in basic self-care activities and in mobility in the months and~     years afterwards. A better understanding of the underlying risk factors for disability~     following critical illness is greatly needed, including the effect that activity during~     hospitalization may have on these outcomes. Therefore, we designed the Measuring OutcomeS of~     Activity in Intensive Care (MOSAIC) observational study to evaluate the relationship between~     activity (measured more rigorously than in prior investigations) and disability, physical~     function, and cognitive function in survivors of critical illness 3 and 12 months after ICU~     discharge.~   "
34435|NCT03115827|"~     The purpose of this study is to find out whether droxidopa, a medication that increases~     norepinephrine levels, may be effective in improving some aspects of cognition and movement~     in Parkinson's disease (PD).~   "
34436|NCT03115814|"~     To investigate the safety of deep brain stimulation in the treatment of severe Alzheimer's~     disease (AD); to investigate the effectiveness of deep brain stimulation in the treatment of~     severe AD, i.e., effects of deep brain stimulation on cognitive function in patients with~     severe AD and dementia grading; to investigate the effects of deep brain stimulation on~     cerebral glucose metabolism in patients with severe AD.~   "
34437|NCT03115801|"~     The trial is open to patients who have metastatic renal cell carcinoma/urothelial (bladder)~     carcinoma with at least 2 measurable sites of disease. All eligible patients will be randomly~     assigned to immunotherapy(nivolumab/atezolizumab) versus immunotherapy~     (nivolumab/atezolizumab) plus radiotherapy, 10 Gy x3 (conformally or by intensity modulation~     radiation therapy/Image-guided radiation therapy (IMRT/IGRT) to maximally spare normal~     tissue), to one of their measurable lesions.~   "
34438|NCT03115788|"~     Cognitive performance will be studied over time using an iPad game interface called the nine~     choice human game (5CH) in normal volunteer subjects before during and after experimentally~     induced thermal (cold or warm) pain or control (no intervention).~   "
34439|NCT03115775|"~     To conduct a randomized, double-blind, controlled clinical trial to determine the independent~     and combined effects of dietary conjugated linoleic acid (CLA) and vitamin D supplementation~     on anabolic signaling, the expression of growth regulatory factors, and muscle protein~     turnover in older adults.~   "
34440|NCT03115762|"~     This trial will investigate the pharmacokinetic,immunogenicity and safety biosimilarity of~     ASKB1202 compared to bevacizumab sold in China and Europe.~   "
34441|NCT03115749|"~     The exact origin of inflammatory bowel disease (IBD) is still unknown. The current hypothesis~     is that IBD is secondary to an abnormal intestinal immun response directed to all or part of~     the intestinal flora in genetically predisposed individuals. Several experimental studies~     have demonstrated the ability of mesenchymal stem cells (MSCs) from bone marrow or adipose~     tissue origin to control intestinal inflammation in animal models. However, to date, there~     are no data regarding the functions of resident MSCs in the colon and small intestine of IBD~     patients. We hypothesize that dysfunction of resident intestinal MSCs contributes to the~     disruption of intestinal homeostasis in patients with IBD causing the development of~     intestinal inflammation. The aim of this research project is to identify, describe and~     characterize at the molecular and functional level MSCs of the colon and small intestine of~     patients with Crohn's disease and ulcerative colitis and to compare them with a control~     population.~   "
34442|NCT03115736|"~     The investigators aim at describing changes in renal glomerular and tubular function with~     after the switch from TDF to TAF in HIV/HBV-coinfected patients with mild to moderate renal~     dysfunction and to assess the virological efficacy of TAF on HBV infection.~      The study will include HIV/HBV-coinfected participants of the Swiss HIV Cohort Study (SHCS)~     who are under active care and have been on a stable, TDF-containing ART regimen for at least~     6 months. Only patients with an estimated glomerular filtration rate (GFR) between 30 ml/min~     and 90 ml/min will be included. All individuals who agree to participate will be switched~     from a TDF-containing ART regimen to a TAF-containing triple ART regimen at week 0 and will~     be followed for 48 weeks after the treatment change.~   "
34476|NCT03115294|"~     Observational study of patients undergoing open heart surgery. During the procedure video~     clips of right heart are stored and compared to trans-oesophageal ultrasound recordings and~     ECG recordings.~   "
34444|NCT03115710|"~     Keratoconus is a ocular disease classified under ectatic diseases which often results in~     bilateral and asymmetrical corneal distortion. It usually affects patients at young age and~     can cause severe visual loss.~      The overall goal of this study is to assess the prevalence of keratoconus (KC) in children~     and adolescents in various regions of the world based on modern tomographic imaging methods,~     and to verify whether the occurrence rates reported from literature should be corrected. Our~     hypothesis is that the prevalence of the disease is much higher than that traditionally~     reported.~      At each site, corneal tomography examinations (Pentacam) will be performed bilaterally in~     children and adolescents, who are not ill or with any ophthalmological symptom. The~     population to be studied will be composed of children and adolescents on medical visits for~     non-ophthalmologic reasons, aged between 6 and 20 years. Multiple cities, from different~     continents (North America, South America, Asia and Europe) will participate.~   "
34445|NCT03115697|"~     Study Design- Randomized Controlled trial Duration of enrolment-Feb-2016 to December 2017~     Sample size-120 patients Methodology We will include consecutive with advanced hepatic~     encephalopathy not responding to treatment of precipitants and on treatment with Lactulose~     and Rifaximin for 48 hours .~      Two groups will be divided. One arm -Lactulose and Rifaximin will be continued Second Arm -~     Plasmapheresis will be added to the standard medical care therapy.(Maximum of 3 sessions once~     in 24 hours/or alternate days with an follow up for 5 days)~   "
34446|NCT03115684|"~     Pain in the emergency room is under documented and pain relief suboptimal. Data on nurse~     driven analgesia in emergency department waiting rooms is lacking. The primary objective of~     this study is to determine the proportion of patients in pain receiving pain therapy~     administered by the triage nurse (prevalence study). The secondary objectives are to 1)~     describe nursing practices in analgesia and adherence to the dedicated protocol; 2) to~     determine the factors associated with the non administration of painkillers and for these~     factors, to estimate the strength of the association~   "
34447|NCT03115671|"~     This research study is carried out to examine the effects of Phosphatidylserine-Omega 3~     supplements (i.e., Vayarin) among children with Autism Spectrum Disorder (ASD) and ADHD.~     Participants will be randomised either to receive the Vayarin treatment (Intervention group)~     or to a Control group.~   "
34448|NCT03115658|"~     The purpose of this study is to learn more about encouraging physical activity among first~     degree female relatives of women with breast cancer. Physical activity can decrease a woman's~     risk of developing breast cancer, on average, by 20%; however, physical activity~     interventions have not been developed specifically for first degree female relatives of~     cancer patients, so currently, it is unknown whether standard physical activity interventions~     are sufficient for these women or if first degree female relatives would benefit from an~     enhanced physical activity intervention that addresses information about breast cancer risk~     reduction. To obtain information about first degree female relatives preferences for a~     physical activity intervention, this study seeks to have first degree female relatives of~     breast cancer patients enroll in a standard physical activity intervention developed for~     healthy men and women. After completion of the three month intervention, the women will be~     asked to participate in two, one-hour long focus group with 5-7 other participants. The first~     focus group is to discuss aspects of the physical activity intervention that they liked and~     did not like, as well as things they think may have enhanced the intervention and made it~     more relevant to other first-degree relative of breast cancer patients. In the second focus~     group, participants will be shown enhancements that were developed based on information~     gathered from the first focus group. Participants will be asked for their feedback on the~     newly developed enhancements.~   "
34449|NCT03115645|"~     Long-term sitting has been associated with multiple health risks. To reduce sitting time for~     office workers in a Dutch insurance company, an intervention will be implemented. The goal of~     this study is to evaluate this intervention on the short term (3 months) and long-term (12~     months).~   "
34450|NCT03115632|"~     There are two aims for this study. The purpose of this study is to determine the effects of~     body weight and hormones on airway fibrosis (scarring) and lung function in obese & lean~     asthma subjects compared to obese & lean non-asthma subjects (Aim 1). And in obese subjects~     with asthma undergoing bariatric surgery compared to obese non-asthma subjects undergoing~     bariatric surgery (Aim 2).~   "
34451|NCT03115619|"~     This multicenter, post-marketing, observational study will evaluate quality of life in~     participants with Idiopathic Pulmonary Fibrosis (IPF) under treatment with pirfenidone~     (Esbriet).~   "
34452|NCT03115606|"~     In patients with cervical spine disorders or hernia, in-line stabilization and immobilization~     during tracheal intubation is used to avoid neck injury. With direct laryngoscopy~     cranio-cervical motion can result injury. The aim of the study is to compare two different~     device (C-Mac D blade versus fastrach LMA ) regarding cervical motions during intubation.~   "
34453|NCT03115593|"~     Endometrial cancer is the most common pelvic gynecological cancer in so-called developed~     countries, with 320,000 new cases annually, including more than 1,500 in Belgium. It~     preferentially affects postmenopausal women. Overall survival at 5 years is 76% but is 95%~     for early forms, which represent more than 70% of diagnoses. The main risk factors are~     obesity, diabetes and tamoxifen intake for breast cancer, which explains the increasing~     incidence. Half a million new annual cases are expected in 2035.~      The main symptom is postmenopausal metrorrhagia.Among these women, the prevalence of the~     disease is estimated between 10 and 15%. Currently the recommendations are to make an~     evaluation by endovaginal ultrasound followed by an endometrial biopsy. The histological type~     is the main predictor of the severity of the disease and acts as guideline for the~     treatment.It is therefore essential to have precise biopsy results before starting~     therapeutic management.~      The most widely used technique is the blind biopsy by aspiration using a pipette because it~     is inexpensive, easy, without any specific equipment. However, recent studies showed that~     this technique has a poor sensitivity in the target population of postmenopausal women. Other~     studies have shown that targeted biopsies under hysteroscopic control could have a much~     higher sensitivity.~      The main objective of this study is thus to compare the performance of the targeted biopsy~     under hysteroscopy to the performance of the biopsy by aspiration with a pipette, for the~     diagnosis of endometrial cancer.~   "
34477|NCT03115281|"~     WIN is a prospective, observational multinational post-marketing registry designed to~     evaluate the safety and effectiveness of the XPOSITION S STENT used in routine clinical~     practice.~   "
34454|NCT03115580|"~     The purpose of this study is to predict any changes in the side branch after stenting the~     main branch blood vessel using three dimensional intravascular images. (Frequency domain~     optical coherence tomography FD OCT).~      Optical coherence tomography (OCT) is an established medical imaging technique that uses~     light to capture high-resolution, three-dimensional images of blood vessels. These images~     will be used before and after implanting the stent in the main blood vessel. Fractional Flow~     Reserve (FFR) test, which makes it possible for the interventional cardiologist to calculate~     blood flow across an area of a coronary artery, will be done after stenting and will help to~     determine if there are any changes in the side branch blood flow.~   "
34455|NCT03115567|"~     This randomized, controlled, phase II clinical study is designed to assess the efficacy of~     preemptive treatment with topical steroids in preventing the papulopustular eruption induced~     by epidermal growth factor receptor inhibitor (EGFRI) treatment in cancer patients.~     Participants will be followed up for 6 weeks of twice daily application of triamcinolone~     cream to the face, chest, and back.~   "
34456|NCT03115554|"~     There is a need to compare the efficacy of PVI versus PVI plus catheter ablation, which~     includes ablation of complex fractionated atrial electrograms (CFAE) and linear lesions in~     the same procedure. If it is found that the PVI alone is as effective as PVI plus catheter~     ablation of CFAE and linear lesions, it may reduce the need for catheter ablation.~   "
34457|NCT03115541|"~     The purpose of this study is to determine the incidence of post-operative venous~     thromboembolism (VTE) in patients undergoing major esophageal resection for malignancy.~   "
34458|NCT03115528|"~     Objectives:~      Primary Objective:~      The primary objective is to identify the difference in the estimation of prognosis of~     advanced cancer patients between medical oncologists, gynecological oncologists, and~     palliative care physicians~   "
34459|NCT03115515|"~     In women who require thyroid hormone replacement medication, the investigators will compare 2~     ways to adjust thyroid medication during pregnancy to determine superiority in maintaining~     optimal blood levels of thyroid hormone. Thyroid hormone requirements increase significantly~     in pregnancy and it is important that blood levels of thyroid hormone remain normal so the~     fetus, which cannot make its own thyroid hormone has enough for early prenatal development.~     This trial compares 2 methods for adjusting thyroid medicine during pregnancy in women with~     known thyroid disease. Pregnant women (age 18 to 45) who take thyroid medication will be~     randomized to either 1) a 2-dose per week increase in thyroid medicine once pregnancy is~     confirmed, followed by dose adjustments every 2-4 weeks, or 2) adjustments in thyroid~     medication every 2-4 weeks in micrograms per day based on results of blood tests. The~     investigators will compare thyroid hormone levels throughout pregnancy between the groups of~     mothers to determine which method is superior in meeting the increased thyroid hormone~     requirements during pregnancy.~   "
34460|NCT03115502|"~     Obese patients have increased cardiovascular risk and target organ damage (TOD) as compared~     to people with normal weight. Weight loss reduces cardiovascular risk and TOD. These changes~     have been associated mainly to changes in inflammatory and pro-atherogenic markers. Office~     peripheral blood pressure (BP) appears to decrease after bariatric surgery, but information~     on changes in 24h-ambulatory-BP-monitoring (24h-ABPM) and central-BP(cBP), or about the~     possible role of renin-angiotensin-aldosterone (RAAS), serotonin(STS) and~     endocannabinoid(ECS) systems is scarce. Our hypothesis is that the hemodynamic changes~     mediated by alterations in the RAAS, STS and ECS after weight loss are also responsible for~     the reduction of TOD.~   "
34461|NCT03115489|"~     The study will investigate the efficacy of the NMDA receptor antagonist ketamine as a first~     line agent in refractory status epilepticus versus traditional general anesthetic agents used~     for burst suppression that target the GABA adrenergic receptors.~   "
34462|NCT03115476|"~     One of the main reasons for treating AK is the wish to lower the risk of progression of AK to~     SCC. This risk is in the order of 1 per 1000 AKs per year, which is in itself a small risk,~     but since patients can have dozens of AKs and the disease is chronic the cumulative risk for~     a patient can be substantial.~      In this extension protocol of trials LP0084-1193, -1194, -1195 and -1196, LEO will study the~     incidence of SCCs and other skin neoplasia in vehicle and ingenol disoxate treated patients~     over a period of 2 years, so that the total follow-up time for each patient will be 3 years~     and 2 months.~   "
34463|NCT03115463|"~     The purpose of this research project is to determine if use of optimized target oxygen~     strategy during delivery room resuscitation can reduce oxidative stress in premature~     newborns. Objective is to compare oxidative stress markers between preterm neonates~     resuscitated in the delivery room using three different target oxygen strategies. OX50 target~     oxygen strategy is currently in use and recommended by neonatal resuscitation program. In~     this strategy oxygen is adjusted to meet the goal transitional saturations which are~     approximated 50th centile saturations observed in healthy term newborns. In OX25 target~     oxygen strategy oxygen will be adjusted to meet the goal transitional saturations which are~     25th percentile transitional saturations observed in healthy term newborns. In OX75 target~     oxygen strategy oxygen will be adjusted to meet the goal transitional saturations which are~     75th percentile transitional saturations observed in healthy term newborns.~   "
34464|NCT03115450|"~     The purpose of this investigator-initiated study is to compare the use of pupilometer and~     ultrasound assessment of optic nerve sheath diameter in predicting the ICP and to see if~     there is a value that could be used to indicate elevated ICP with either modality as these~     numbers are inconsistent throughout the literature. Patients that have either an external~     ventricular drain (EVD) or bolt placed will be enrolled in the study. After the EVD and bolt~     are placed the patient will undergo pupilometer examination (standard of care) followed by~     ultrasound assessment of the optic nerve sheath diameter (ONSD). The three values will be~     recorded. The same patient may have multiple readings performed if there is a change in ICP~     either spontaneously or due to intervention.~   "
34478|NCT03115268|"~     The project will investigate the feasibility and acceptability of a remote support group~     intervention for people with aphasia, and will investigate the impact of that intervention on~     measures of wellbeing, quality of life and communication. The intervention will be delivered~     to 32 participants in Eva Park, a virtual island specifically designed for people with~     aphasia.~   "
34479|NCT03115255|"~     To determine the serum concentrations of ranibizumab and vascular endothelial growth factor~     (VEGF) in infants with retinopathy of prematurity (ROP) who received intravitreal ranibizumab~   "
34465|NCT03115437|"~     The main goal is to investigate the influence of shoe cushioning and body mass on the risk of~     running-related injury. This study will allow to determine if shoe cushioning needs to be~     adapted to the mass of the runner in order to minimize injury risk. The influence of shoe~     cushioning on running technique will also be investigated.~      This study consists in a 6-month follow-up period during which leisure-time runners are~     required to perform a running activity at least once a week and to upload all their running~     as well as other sporting activities onto a secured web-based training calendar named~     Training and Injury Prevention Platform for Sports (TIPPS) on a weekly basis. Any injury~     sustained during this period should also be uploaded onto the TIPPS system using the injury~     questionnaire provided on the website. Finally, the day of the visit to the laboratory (study~     start), their running style will be analysed during a 15-minute run on an instrumented~     treadmill at the participant's usual running speed. Anthropometric measurements will also~     taken.~      Before the beginning of the study, the participants will receive a pair of running shoes free~     of charge. These shoes will either have a soft or hard sole. Both shoe versions have~     cushioning properties that correspond to the range of values from the shoes available on the~     market. They will be administered through random allocation. Neither the participants nor the~     research team will know which shoe version was provided to the participant, in order to~     respect the double-blinded methodology of this study. The participants will be required to~     use these shoes for all running sessions, and only for running activities.~      Hypotheses:~      H1: Running shoes with greater stiffness are associated with a higher injury risk in~     leisure-time runners.~      H2: High body mass is associated with a higher injury risk in leisure-time runners.~      H3: Runners with a high body mass experience a lower injury risk in shoes with greater~     stiffness.~      H4: A higher step length, a lower step frequency, and higher peak vertical impact forces are~     associated with a higher injury risk.~      H5: Running shoes with greater stiffness will be associated with higher vertical impact peak~     forces and a shorter contact time.~      H6: High body mass will be associated with higher peak vertical impact forces, increased~     contact time, increased duty factor, and decreased step frequency.~   "
34466|NCT03115424|"~     Observational studies suggest that bariatric surgery is the most effective intervention for~     weight loss. Comparative effectiveness of Roux-en-Y Gastric Bypass (RYGB) and Sleeve~     Gastrectomy (SG) demonstrate that RYGB is significantly superior to SG in terms of weight~     loss and glycemic control. Both RYGB and SG increase GLP-1 concentrations which directly~     affect B-cell function. Data has shown that the postprandial rise in GLP-1 might affect~     feeding behavior after RYGB and to a lesser extent SG, where the increase in GLP-1 is less~     marked. In this study the investigators propose to randomize subjects undergoing SG to~     receive either placebo or Liraglutide, a GLP-1 receptor agonist, to compare weight loss and~     CV risk factors.~   "
34467|NCT03115411|"~     Evaluation of ERCP with placement of a winged plastic biliary stent without a lumen for~     management of benign biliary strictures.~   "
34468|NCT03115398|"~     By utilizing fitness trackers, this study aims to demonstrate that a simple walking program~     improves patients' ability to tolerate curative concurrent chemoradiotherapy without~     treatment interruption.~   "
34469|NCT03115385|"~     This study will recruit 40 obese Hispanic youth (12 - 18 years of age who are greater than or~     equal to Tanner stage 4) from hospitals, clinics, and community centers. Participants will be~     randomly assigned to 16 weeks of probiotics (3 packets/day of VSL#3) or matched placebo. The~     purpose of this study is to demonstrate through a proof-of-concept trial that probiotics have~     the potential to alter the gut microbiome and gut hormones.~   "
34470|NCT03115372|"~     This randomized clinical trial studies how well a lay health worker outreach works in~     increasing colorectal cancer screening in Asian Americans. Training community members to~     educate participants about colorectal cancer and its prevention may improve colorectal cancer~     screening rates in Asian Americans.~   "
34471|NCT03115359|"~     Chronic low back pain (CLBP) has no known effective treatment. While often treated with~     long-term opioid therapy, opioids do not work well for many patients and can cause serious~     side effects, including addiction, poorer mental health, and overdose death. Even when paired~     with a standard-of-care cognitive behavioral therapy (CBT), results are limited. Patients,~     families and clinicians are very interested in using alternative treatments for CLBP,~     especially complementary and integrative treatments such as mindfulness meditation (MM). MM~     helps train the mind to bring non-judgmental and accepting attention to present-moment~     experiences such as pain. MM offers an active and safe self-care approach to chronic pain~     that contrasts with the passive and potentially harmful nature of opioid treatment, and may~     prove more effective than CBT in helping improve health and well-being, and reduce reliance~     on opioids in adults with opioid-treated CLBP. Although this hypothesis is supported by early~     research, including a pilot study by the Principal Investigator, evidence on MM's~     effectiveness in this population is inconclusive, presenting a critical knowledge gap.~      With input from patients, family members, and clinicians, the Investigators have designed a~     study to address this gap and propose a clinical trial that will compare the effectiveness of~     MM to standard-of-care CBT in opioid-treated CLBP. Based on the existing research, it is~     hypothesized that MM training will lead to a larger reduction in pain intensity, increase in~     physical function, improvement in quality of life, and decrease in daily opioid dose, as~     compared to CBT training, with benefits of MM especially notable in adults with worse mood,~     anxiety or unhealthy opioid-use behaviors who often experience more severe symptoms of CLBP~     and less improvement in response to existing therapies.~      To test these hypotheses, 766 adults with opioid-treated CLBP from Madison, WI, Boston, MA,~     and Salt Lake City, will be randomly assigned into one of two 8-week treatment groups: MM~     (383 participants) that will receive the MM training or CBT (383 participants) that will~     receive the CBT training. The effectiveness of MM versus CBT will be assessed over a 12-month~     period with patient-reported measures, recommended by experts and endorsed by our stakeholder~     partners, including patients with opioid-treated CLBP, their families and clinicians.~   "
34472|NCT03115346|"~     This study tests the use of a decision aid for Veterans who are facing a decision about~     surgery for their aortic abdominal aneurysms (AAA). The investigators will enroll Veterans~     with AAA who are candidates for endovascular or open surgical repair. There are 20 VA medical~     centers participating in the trial. Ten sites will be randomly assigned to the intervention~     group, and 10 sites will be randomly assigned to the control group. Twelve Veterans will be~     enrolled at each site. At sites assigned to the intervention arm, Veterans will receive a~     decision aid with information about the two types of surgery for AAA repair, open and~     endovascular, and complete a survey about their preferences. Veterans at control sites will~     complete the same survey, but will not receive the decision aid. After their surgery,~     Veterans will take another survey asking about their satisfaction. The investigators will~     compare the results of the survey between Veterans' in the intervention and control groups to~     determine the effect of the decision aid on agreement between preference and repair type.~   "
34473|NCT03115333|"~     This phase II trial studies how well dynamic susceptibility contrast-enhanced magnetic~     resonance imaging (DSC-MRI) works in measuring relative cerebral blood volume (rCBV) for~     early response to bevacizumab in patients with glioblastoma that has come back. DSC-MRI may~     help evaluate changes in the blood vessels within the cancer to determine a patient?s~     response to treatment.~   "
34474|NCT03115320|"~     The primary aim of this study is to find out if ovulation triggered with hCG provides any~     additional benefit in comparison to spontaneous LH surge measured with the home test when~     transferring frozen-thawed embryo in a naturally stimulated cycle.~   "
34475|NCT03115307|"~     This study is a prospective randomized trial with 242 IUI cycles. Patients are randomized in~     two groups including 121 patients in each group. In the first group, the patients will be~     treated with triptoreline (Gonapeptyl®) in their luteal phase. As for the other group, the~     patients will undergo the luteal phase without any supportive medication. This study is going~     to clarify the role of the gonadotropin agonist (triptoreline, Gonapeptyl®) as a luteal phase~     supporter. The benefit of the treatment is measured by the numbers in the live birth and~     clinical pregnancy rates.~   "
34481|NCT03115229|"~     The aim of this study is to determine the effect of preventive nursing interventions, which~     consist of education / practices including of healthy eating and physical activity and~     motivational messages which sent through social media to reduce obesity risk in university~     students who in the risk group for obesity.~   "
34482|NCT03115216|"~     This pilot study aims to primarily assess the rate of complication of anterior vitrectomy for~     patients undergoing femtosecond laser-assisted (FLA) cataract extraction and intraocular lens~     placement (CEIOL) compared to manual CEIOL, when performed by resident physicians under~     direct attending supervision. In this pilot study, the investigators aim to assess what the~     incidence of anterior vitrectomy is for each group, in order to better understand the sample~     size needed to assess whether there is a difference between these two groups. Secondarily, it~     will gather preliminary data on safety and refractive outcomes for patients undergoing these~     interventions.~   "
34483|NCT03115203|"~     The problem posed is the possibility of objectively assessing facial muscle mobility.~      Today, in patients with facial paralysis, the assessment of the deficit is carried out using~     a subjective scale such as the House Brackman [1] or EMG scale of the facial nerve but does~     not distinguish each muscle individually . Objective measurements of skin muscles such as~     thickness and volume, in preoperative assessment of a facial paralysis rehabilitation~     surgery, would be useful in order to choose the most appropriate surgical technique. Indeed,~     too much amyotrophy will contraindicate hypoglosso-facial anastomosis (VII-XII) and it will~     be preferable to propose a temporal elongation myoplasty or a reinfused free muscle flap.~      Similarly, it would be useful to be able to objectively evaluate the recovery of muscle~     function after facial allo-transplantation.~      Although electromyography has been developed since the work of Duchenne de Boulogne, little~     research has been carried out on the development of noninvasive methods to objectively~     characterize in vivo skin muscles (variation, position, orientation, morphometry). The main~     morphometric data of the skin muscles come from anatomical dissections.~      Imaging of the skin muscles has not been specifically developed. Some studies have been~     carried out to visualize these muscles in MRI 1.5 Tesla in pathologies such as myasthenia~     gravis, facial paralysis, and labio-alveolo-palatine clefts for example.~      The originality of the project is to develop a method allowing to establish a quantitative~     correlation between the movements of the face and the muscular changes. This correlation will~     be achieved by associating muscular morphological data derived from MRI acquisitions and~     cutaneous deformations resulting from clinical examinations. This non-invasive approach~     should make it possible to establish objective and reproducible indicators in patients with~     facial paralysis sequelae.~   "
34484|NCT03115190|"~     Rationale: This study aims to aid the general practitioner (GP) in the diagnostic dilemma of~     chest pain patients. Patients with acute coronary syndrome (ACS) should be referred to the~     hospital promptly, though referring all patients with chest pain is not feasible, as up to~     80% of the patients with chest pain in the primary care do not have ACS.~      Objective: The primary objective is to refer patients who contact the out-of-hours GP~     cooperation (GPC) with suspicion of ACS more accurately with a hypothesized reduction of 10%~     in unnecessary referrals.~      Study design: This study is a prospective, observational, prevalence-based cohort study~     within the standard care of ACS patients.~      Study population: All patients with chest pain, or other complaints suspect of ACS, will be~     included in which the GP at the GPC is in need of further diagnostics to come to a decision~     of referral. The follow-up will be a registry of all patients with suspected ACS referred to~     the emergency department (ED). Patients with typical complaints of ACS, and thus a high~     suspicion, will be excluded and referred promptly.~      Intervention: Triage nurses working at the GPC will receive specific ACS training. Patients~     who arrive at the GPC with non-typical chest pain, will be screened for enrolment within the~     study. The GP evaluates patients using the Heart score, this includes electrocardiogram~     recording and point of care (POC) troponin testing. With the Heart score the GP can make an~     informed decision to refer the patient to the ED.~      To evaluate the intervention a registry of all patients referred to the ED with suspected ACS~     will be compared to a baseline registry performed from the 1st of September 2015 until the~     1st of March 2016. Patients not referred to the ED, will have a (standard) high-sensitivity~     troponin and a POC troponin as follow-up at least four hours (up to 24 hours) after first~     measurement.~      The burden and risks associated with participation, benefit and group relatedness: Patients~     enrolled within this study will receive a finger stick blood test and electrocardiogram~     recording at the GPC and a finger stick blood test and a venous blood test at least four~     hours after first troponin measurement. We may follow-up by telephone if we can not obtain~     the required information from medical records. We expect no adverse events and there are no~     expected risks associated with this protocol. We expect patients with ACS to be referred more~     accurately and more promptly to the ED and thus lowering risks.~   "
34485|NCT03115177|"~     The purpose of this study is to investigate antibiotic treatment to target bacteria about the~     shoulder. This bacteria, Propionibacterium acnes, is detected in many revision shoulder~     surgeries and is thought to contribute to periprosthetic joint infections, pain, and failure~     of total shoulder arthroplasty as well as other shoulder surgeries. This study is~     investigating adding an FDA approved antibiotic that is commonly used for treatment of this~     bacteria and many common infections. The investigators will take intraoperative cultures to~     look for the presence or absence of specific bacteria. The investigators are conducting this~     trial to see if adding another antibiotic to specifically target this common bacteria found~     around the shoulder will be effective.~   "
34486|NCT03115164|"~     Astrocytomas / infantile desmoplastic gangliogliomas (DIA / DIG) are rare brain tumors~     usually affecting infants. They represent about 0.5% of all pediatric brain tumors. DIA / DIG~     occurs mainly in the first 2 years of life, with a sex ratio M / F of 1.7 to 1. From a~     histological point of view, DIA / DIG are neuroepithelial tumors. These tumors may have a~     purely astrocytic differentiation (DIA) or be composed of tumor cells with astrocytic and~     neuronal differentiation (DIG). The desmoplastic component is usually adjacent to the~     meninges and is defined by the increase or modification of connective tissues related to the~     presence of neoplastic cells with the formation of a collagen-rich extracellular matrix.~      Due to their benign biological behavior and favorable clinical course, they are classified in~     benign tumors, ie grade I according to the WHO classification. However, all tumors called DIA~     / DIG do not behave in a benign manner. Cases of metastatic cerebrospinal and malignant~     disorders have been described. It appears that about 40% of DIG cases require additional~     medical treatment such as chemotherapy, radiotherapy and / or new surgery, and 15% of infants~     and children with GIDD die from the disease. It is possible that what is grouped within the~     DIA / DIG is a heterogeneous group of tumors, evolution and prognosis very variable.~      The cytogenetic knowledge of DIA / DIG is very limited and is only available on small numbers~     of cases. Cytogenetic analyzes of several cases of DIG showed normal karyotypes. More~     recently, a CGH-Array study of 3 cases of DIA / DIG did not find any significant chromosomal~     gains or losses.~      It has been shown, however, that a mutation involving BRAF (BRAF rearrangement or BRAF V600E~     mutations) was a recurrent element in low grade gliomas, particularly in pediatric patients.~      It is also suggested that deregulation of BRAF activity in some DIA / DIG may indicate the~     importance of the MAPK (mitogen-activated protein kinase) pathway in signaling pathways for~     DIA / DIG development. However, data on the link between the BRAF gene and DIA / DIG remains~     very limited. Thus, further studies are needed to study the other members of the MAPK pathway~     in DIA / DIG (eg PI3K / AKT / mTOR). This could provide new therapeutic possibilities~     involving targeted therapies specific to the MAPK signaling pathway.~      It appears that DIA / DIG does not all behave in a benign manner and some would undergo a~     malignant transformation that could be due to chromosomal alterations such as, for example,~     TP53, PI3K. In addition, because of the limited number of cases, it would be interesting to~     study the characteristics of patients with DIA / DIG in order to study their characteristics~     and whether there are clinical, pathological, cytogenetic and / Molecular forms between~     benign and malignant forms.~   "
34487|NCT03115151|"~     Postoperative analgesia following spine surgery is difficult to manage. Current treatment~     modalities rely heavily on opioid analgesics with all of the inherent limitations and side~     effects. While current best practice focuses on a 'multimodal approach' (i.e. using multiple~     different drugs and techniques to control pain after surgery), there is no consensus~     regarding which components of this multimodal therapy provide optimal analgesia. This~     prospective randomized study will enroll patients undergoing elective Lumbar Spinal Fusion~     Surgery at Zale Lipshy University Hospital. The primary objective is to determine the~     comparative efficacy of epidural analgesia, as compared with intravenous (IV)~     patient-controlled analgesia (PCA), on post-operative analgesia.~   "
34488|NCT03115138|"~     Glioblastomas (GBM) are rare tumors of poor prognosis and their treatment is based on surgery~     followed by radiochemotherapy. Clinical and imaging evaluation is not always straightforward:~     the more or less complete surgery, the pseudo-progression after radiochemotherapy, the~     radionecrosis, the diagnosis of the relapse and the follow-up under anti-angiogenic can pose~     problems Clinicians and radiologists. Accessibility to a plasma tumor molecular marker would~     greatly facilitate the follow-up of these patients.~      It is now established for many cancers that circulating tumor DNA (cTNA) has the same~     molecular abnormalities as those identified in the primary tumor cells. Numerous studies have~     shown the prognostic value and diagnosis of the exploration of cDNA.~   "
34489|NCT03115125|"~     Severe sepsis and septic shock are the most severe forms of sepsis (which associates a~     systemic inflammatory response with infection). These are serious pathologies with a~     lethality estimated at almost 40% at 28 days (after the onset of sepsis).~      After a first pro-inflammatory phase, a second compensatory phase called Compensatory~     Anti-Inflammatory Response Syndrome (CARS) takes place quickly. Patients then show signs of~     immunosuppression and profound alterations in immune functions. It is during this phase that~     the vast majority of deaths occur, far from the onset of the shock, which is related to the~     inability of the immune system to eliminate the initial infectious agent and / or a greater~     susceptibility Important to develop secondary infections (nosocomial infection, latent virus~     reactivation ...).~      The CARS phase has been the subject of studies focusing on measuring the plasma concentration~     of anti-inflammatory cytokines (such as Interleukin (IL) -10), the percentage of regulatory T~     lymphocytes (Treg), Or the percentage of monocytic expression of HLA-DR in septic patients.~      The investigator proposes to carry out the first study on a newly described regulatory~     lymphocytic subpopulation: regulatory B lymphocytes (Breg) from a quantitative and functional~     point of view in severe septic states.~   "
34490|NCT03115112|"~     The purpose of this study is to investigate the effect of bexagliflozin compared to~     sitagliptin as an add-on therapy to metformin in lowering hemoglobin A1c (HbA1c) levels in~     subjects with type 2 diabetes mellitus (T2DM).~   "
34491|NCT03115099|"~     The aim of this trial is to evaluate the safety of single doses of a study drug known as~     LY3325656 that is given orally to healthy participants and participants with type 2 diabetes.~     Information about any side effects that may occur will be collected.~      It will also investigate how much of the study drug gets into the blood stream, and how long~     it takes the body to get rid of it.~      The study consists of two parts. Part A will study healthy participants over approximately 12~     weeks and Part B will study participants with type 2 diabetes over approximately 5 weeks,~     excluding screening. Screening is required within 28 days of the start of the study.~   "
34492|NCT03115086|"~     This is a prospective, observational, non-interventional patient registry designed to~     document long term safety and clinical outcomes for 10 years in patients treated with~     Cholbam/Kolbam, including those who have been using Cholbam/Kolbam and those who start~     Cholbam/Kolbam treatment at enrollment.~   "
34493|NCT03115073|"~     This is a multi-center, randomized, prospective, active-controlled, double-blind,~     dose-escalation study comparing dose response of clinical efficacy, safety, local~     tolerability of three different doses of ProF-001/Candiplus® (Candiplus® 0.2%, Candiplus®~     with 0.3%, Candiplus® with 0.4%) to 1% clotrimazole vaginal cream.~      Patients with acute episode of vulvovaginal candidiasis (VVC) will be randomized to receive a~     daily dose of either 5 ml (intravaginal) of Candiplus® at three different doses for the first~     3 days and 2.5 ml for the remaining 3 days or 5 ml (intravaginal) application of 1%~     clotrimazole cream over the first 3 days and 2.5 ml for the remaining 3 days according to the~     following scheme (with each application 2 cm of cream will be applied to the vulvar region):~      Cohort 1: Candiplus® 0.2% versus clotrimazole mono Cohort 2: Candiplus® 0.3% versus~     clotrimazole mono Cohort 3: Candiplus® 0.4% versus clotrimazole mono Randomization into the~     cohorts will occur consecutively from the lowest dose to the highest dose, i.e. patients will~     be randomized first in cohort 1 and finally in cohort 3.~      The proposed study is - after a pilot study to assess critical pharmacokinetic data - the~     second study within a clinical trial program with the objective to develop a new combination~     therapy for the treatment of vulvovaginal candidiasis.~      The new combination consists of two registered drug substances.~   "
34494|NCT03115060|"~     Fluid management being an important component of surgery becomes more challenging for an~     anesthesiologist in case of renal transplant. Ischemia-reperfusion injury is an inevitable~     consequence of kidney transplantation, leading to metabolic acidosis .Normal saline (NS; 0.9%~     NaCl) is administered during kidney transplantation to avoid the risk of hyperkalemia~     associated with potassium-containing fluids. Plasmalyte is another fluid which can be used~     and probably will lead to better metabolic profile in these group of patients.The primary~     objective of this study will be to compare the effects of using normal saline (NS), Ringer~     lactate and Plasmalyte as intravenous fluids on acid-base balance and electrolytes during~     living donor kidney transplantation. Secondary outcomes assessed will be the effect on renal~     function.~   "
34495|NCT03115047|"~     Comparing two treatments for shivering after cesarean delivery for labor dystocia under~     epidural anesthesia.~   "
34496|NCT03115034|"~     The main purpose of this study is to evaluate the effects of melatonin in the regulation of~     the vascular injury in patients under carotid endarterectomy through population-based,~     randomized, double-blind, placebo-controlled trial.~   "
34497|NCT03115021|"~     This study aims at comparing the effects of transcranial direct current stimulation and~     transcranial pulsed current stimulation on neurophysiological outcomes on patients with~     disorders of consciousness. This study also aims to evaluate the effects of these techniques~     on patients' level of consciousness.~   "
34506|NCT03114904|"~     The withdrawal syndrome in benzodiazepines and morphine is common in intensive care, the~     incidence is estimated at 32.1%.~      Cerebrospatized patients are probably more prone to withdrawal because they require high~     doses of sedation.~      Moreover, this syndrome is probably deleterious on the cerebral hemodynamics (high point of~     the therapeutic management).~   "
34707|NCT03112278|"~     Ultra-thin bonded posterior occlusal veneers represent a conservative alternative to~     traditional onlays and complete coverage crowns for the treatment of severe erosive lesions.~     Therefore, the purpose of this study is to determine whether ceramic and composite resin~     ultrathin occlusal veneers (0.6 - 1.0 mm thick) are effective in the rehabilitation of~     patients affected by moderate and severe dental erosion.~   "
34498|NCT03115008|"~     I plan to investigate the value of video-based feedback in endoscopic training -~     specifically, the role of terminal video feedback as compared to usual concurrent feedback on~     cold snare polypectomy technique in trainees, using Direct Observation of Polypectomy Skills~     (DOPyS) competency score. I have focused the study on the competency of cold snare~     polypectomy for subcentimeter polyps. The majority (>75%) of colon polyps are smaller than~     one centimeter. Cold snare polypectomy has been shown, and recommended by the American~     Society for Gastrointestinal Endoscopy (ASGE), to be an effective removal technique. However,~     its widespread use and moreover, its teaching to trainees is lacking. It takes time and~     resources to learn and teach endoscopic techniques. Our study will hope to identify a~     mechanism through video-based feedback that could help to improve the translation of the~     training of polypectomy skills to its actual performance, and to accelerate the learning~     curve.~   "
34499|NCT03114995|"~     Investigators aimed to test the beneficial effect of tirofiban, a GPIIb/IIIa antagonist, for~     Non-ST-Elevation Acute Coronary Syndrome Patients who has high resistance to clopidogrel.~   "
34500|NCT03114982|"~     This study evaluates the immunogenicity and safety of three different potencies of NBP608 and~     Varivax which are indicated for active immunization for the prevention of varicella. Total of~     152 subjects (38 subjects per each treatment arm) of 12 months to 12 years of age are~     enrolled, and each subject is administered with single dose of vaccine which is randomly~     assigned.~   "
34501|NCT03114969|"~     For effective drug delivery using inhalation route, it is important to use the inhalers~     correctly. This open-label study will evaluate the error rates during the use of ELLIPTA DPI,~     alone or in combination, in comparison with other DPIs. The study aims to provide clinical~     evidence in subjects with COPD that the reduced number of steps required to use the ELLIPTA~     DPI could result in fewer errors made by subjects, and therefore a more consistent treatment.~     Approximately 450 subjects prescribed with either of RELVAR® ELLIPTA, ANORO® ELLIPTA,~     INCRUSE® ELLIPTA, SYMBICORT® TURBUHALER®, SERETIDE® DISKUS®, SPIRIVA® HANDIHALER®, ULTIBRO®~     BREEZHALER® or SEEBRI® BREEZHALER will be included in the study and will have 2 clinical~     visits. At Visit 1, subjects will take their maintenance DPIs and the critical and overall~     errors made by subjects will be assessed. After the assessment, subjects will be instructed~     on correct use or informed of their correct use of their DPIs. The total duration of the~     study is approximately 6 weeks. ELLIPTA, SERETIDE and DISKUS are registered trademarks of the~     GSK group of companies. SYMBICORT and TURBUHALER are registered trademarks of the AstraZeneca~     group of companies. SPIRIVA and HANDIHALER are registered trademarks of Boehringer Ingelheim~     Pharmaceuticals. ULTIBRO, BREEZHALER and SEEBRI are registered trademarks of the Novartis~     group of companies.~   "
34502|NCT03114956|"~     Peri-implantitis represents a major biological complication of implant dentistry with~     reported prevalence of up to 47% of implants. The disease is characterized by inflammatory~     response to the biofilm inhabiting the implant surface. To treat this inflammatory disease,~     surgical and non-surgical therapies have been proposed, all of which entail biofilm removal~     through implant surface decontamination. Systematic review of various surface decontamination~     protocols has failed to demonstrate superiority of any of the protocols. One possible~     explanation is that most studies have examined decontamination of implant surfaces following~     experimentally-induced peri-implantitis, where implant surfaces lack the tenacious~     mineralized biofilm often found in clinical peri-implantitis and are therefore easily~     decontaminated.~      The investigators have hypothesized that control of inflammation and repair of pathologically~     damaged peri-implant tissues requires a comprehensive mechanical plus chemical surface~     decontamination therapy. The aims of this study are to 1) determine the most effective~     surface decontamination protocol that can lead to control of peri-implant inflammation and 2)~     delineate the microbial and immunological mediators that are associated with the changes in~     peri-implant inflammation. The investigators propose to compare conventional implant surface~     contamination techniques to a comprehensive mechanical plus chemical protocol. This~     randomized controlled clinical trial seeks to enroll 68 participants with at least one~     implant diagnosed with moderate to severe peri-implantitis. Pre-op parameters to be assessed~     include: probing pocket depth, bleeding on probing, suppuration, plaque index, marginal~     inflammation, recession, clinical attachment level, inflammatory biomarkers and microbial~     sampling, and digital intra-oral peri-apical radiograph. Subjects will be randomly assigned~     to one of the four surgical debridement intervention groups: (A) gauzes soaked in sterile~     saline and chlorhexidine; (B) Titanium brush; (C) Air power abrasion; (D) comprehensive~     surface decontamination, including titanium brush, air powder abrasion and surface etching~     with 9.6% hydrofluoric acid gel. At 3-months post-operative, the initial clinical assessment~     will be repeated. The clinical examination will be used to analyze the efficacy of each~     treatment in controlling peri-implant mucosal inflammation. The ultimate objective of this~     research is not only to identify an effective method for control of peri-implant~     inflammation, but also to lay the foundation to detect biomarkers of peri-implantitis that~     can potentially be helpful in future studies as risk factors of this disease.~   "
34503|NCT03114943|"~     This study assesses non-inferiority by comparing seroconversion rate of NBP608 to Varivax~     which are indicated for active immunization for prevention of varicella. Total of 488~     subjects (244 subjects per treatment arm) of 12 months to 12 years of age are enrolled, and~     each subject is administered with single dose of vaccine which is randomly assigned.~   "
34504|NCT03114930|"~     Prior to the HAS recommendations of March 2014, the mother - newborn couple was discharged~     from the maternity home at 4 days after delivery by AVB and 5 days after caesarean section.~      The stay in maternity allowed a follow-up of the newborn whose weight gain and the occurrence~     of a jaundice; And monitoring of the mother whose milky ascent and psychological feelings.~      In March 2014, the HAS published new recommendations on maternity leave arrangements for the~     mother - newborn couple, the organization of postpartum follow - up for the mother and~     pediatric follow - up for the newborn. The HAS then defines so-called optimal conditions~     for so-called standard outputs, with 9 criteria to respect respectively for the mother and~     the newborn.~      If the mother-to-newborn couple respects these so-called optimal conditions and is eligible~     according to the respective criteria, the latter leaves at home after 72 hours and before 96~     hours for an AVB and after 96 completed hours and Before 120 hours for caesarean delivery.~      As no pediatric discharge was done in the afternoons at the maternity hospital of Amiens, an~     arbitrary choice was made to allow a standard release to the mother-newborn couple only~     if the child was born between 00H00 and 11H59 so that his clinical examination of exit is~     carried out at 72 hours of the birth as recommended by the recommendations of the HAS.~      These recommendations being recent (2014), no study has studied the impact and consequences~     on the triad father / mother-newborn of these exits including the occurrence of possible~     complications or events: re-hospitalizations again The early termination of breastfeeding,~     and whether the follow-up procedures advocated by the HAS are being followed.~   "
34505|NCT03114917|"~     This is a randomised controlled trial which investigates the effectiveness of CARMS~     (Cognitive AppRoaches to coMbatting Suicidality) therapy in reducing suicidal thoughts and~     how well CARMS works in practice within the NHS. The trial will compare two groups of people~     with psychosis who are using NHS mental health services. One group will carry on with their~     usual treatment. The other group will be offered 24 weekly sessions of CARMS therapy, plus~     their usual treatment.~   "
34507|NCT03114891|"~     This is a Phase I Clinical Trial designed to evaluate novel transcranial magnetic stimulation~     (TMS) methods for treating depression/PTSD. TMS is an FDA-approved procedure for~     treatment-resistant depression. The use of the stimulation in this current study is~     considered experimental. The purpose of this research study is to compare the effects of TMS~     at two different brain regions. This information will help the investigators to determine~     which treatment strategies provide the greatest clinical benefit to patients. Results of the~     study will provide brain and behavior measures for future work, which may be critical to~     developing effective disease markers and novel treatments for psychiatric conditions.~   "
34508|NCT03114878|"~     A prospective, randomized, controlled, clinical trial with blind evaluator that uses TRT and~     EMDR as a treatment for tinnitus.~   "
34509|NCT03114865|"~     The investigators primary objective is to determine the safety and toxicity of incorporating~     blinatumomab into the post-allogeneic hematopoietic stem cell transplant (HSCT) maintenance~     setting for patients with CD19+-B-cell malignancies (Acute Lymphoblastic Leukemia [ALL],~     Non-Hodgkin's Lymphoma [NHL]).~   "
34510|NCT03114852|"~     The REGENT study (Familiar Renal Disease, Epidemiology and Genetics in Niteroi/Rio de~     Janeiro) is a epidemiological study that try to identify and clinically describe questions~     about genetic renal diseases in a southeast Brazilian population undergoing renal replacement~     therapy.~   "
34511|NCT03114839|"~     Currently, obtaining samples directly from the small bowel is difficult due to the highly~     invasive intubation methods used. Research on the effect of dietary probiotics on the gut~     microbiota is therefore largely dependent on measurement of the microbial composition in~     fecal samples. At best, the measurement in fecal samples reflects microbial composition of~     the large intestine. The microbial composition in the small intestine differs substantially~     from the composition in feces. In addition, many physiological processes that are modulated~     by dietary probiotics, such as immunoregulation, mainly occur in the small intestine.~     Therefore, it is vital to study the effects of dietary probiotics on the small intestinal~     microbiota, as well. Successful sampling of the small intestine has been demonstrated in~     animals and humans, using the IntelliCap® CR system. The main aim of the current study is to~     explore and compare the small intestinal microbiota profiles in healthy subjects before and~     after consumption of a probiotic drink containing Lactobacillus casei strain Shirota (LcS)~     (Yakult®).~   "
34512|NCT03114826|"~     Renal transplant patients have on average 3-5 times more risk of developing cancer than the~     general population. This rate can be increased up to 10 to 15 times in some type of cancer~     like kidney cancer. Among the identified risk factors, immunosuppressants and, in particular,~     calcineurin inhibitors (ciclosporin and tacrolimus) play a major role in increasing cancers~     apart from their depressant effects on the immune system.~      Calcineurin inhibitors (CCN) are the basis of immunosuppressive therapy in renal~     transplantation. Several mechanisms have been implicated to explain their pro-oncogenic~     properties. One related to an increase in VEGF expression seems particularly interesting in~     the study of renal cell carcinoma in the transplanted patient. Indeed, the physiopathology of~     kidney cancer has clearly been associated with an increase in the production of VEGF.~     Furthermore, some polymorphisms of the gene encoding VEGF have already been associated with~     the survival of patients with renal carcinoma and the circulating level of VEGF in the~     general population. The search for an association between the polymorphisms of the VEGF gene~     and renal carcinoma in renal transplant patients could thus identify patients whose risk of~     renal cell carcinoma (cRCC) post-transplantation is increased. If the involvement of certain~     polymorphisms in the development of cRCC was confirmed in this population, their research~     before the introduction of the immunosuppressive treatment would make it possible to direct~     the choice of treatment towards molecules without pro-oncogenic property in the Patients such~     as mTOR protein inhibitors (sirolimus, everolimus). This research project is therefore in~     line with the desire to move towards a more personalized medicine that could be beneficial~     for the patient.~   "
34513|NCT03114813|"~     Aim:~      To test if MRI can detect meaningful changes in portal pressure in the liver to assess~     whether treatment with beta-blockers has worked.~      Liver Disease:~      Most people with liver disease do not have symptoms. Over time they develop 'cirrhosis' -~     severe liver scarring. In the United Kingdom deaths due to cirrhosis have doubled over the~     last decade, because of increasing rates of alcohol consumption and obesity, while heart,~     kidney, lung diseases, strokes and cancer fatalities have fallen.~      Portal pressure:~      Cirrhosis causes increased pressure within the liver and changes in the circulation leading~     to the development of varicose veins in the gullet and stomach called 'varices'. Varices~     bleed easily, leading to emergency situations that can be life threatening. However, if the~     increased pressure within the liver (portal pressure) is detected early, then treatment can~     prevent variceal bleeding. The only test we have to predict prognosis and treatment success~     in someone with cirrhosis is by measuring the portal pressure.~      Measuring portal pressure:~      Currently the only existing test to measure portal pressure is to pass a pressure sensor~     through a vein in the neck, down into the liver. This is called the hepatic venous pressure~     gradient (HVPG) measurement. The HVPG measurement is disliked by patients because it is an~     invasive procedure. It is also expensive and not widely available. Hence, patients with~     cirrhosis need to have regular camera tests (endoscopies) to look for varices.~      How can you treat varices?~      Two options;~        1. With tablets to lower the pressure (beta-blockers)~        2. Endoscopy treatment (banding)~      Both have advantages and disadvantages;~        -  Beta-blockers only lower the portal pressure in about half of those that take them, with~          some evidence they may also have a protective effect against infections from the bowel~          by increasing the speed of bowel motion~        -  Treating the varices with endoscopy requires several endoscopies and can lead to~          life-threatening bleeding.~      Most patients are therefore given beta-blockers and monitored closely to see if they work.~      Why does it matter?~      Beta-blockers can cause side effects (e.g. fainting) that are unpleasant enough to make up to~     one third of patients stop taking them. Beta-blockers only reduce the portal pressure in half~     of patients. The remaining patients are exposed to potential side effects and possible harm~     in those with the most advanced liver disease. These patients may still have a~     life-threatening bleed as the varices have not been adequately treated. There is a desperate~     need to discover whether the portal pressure changes with treatment (such as with~     beta-blockers) without invasive tests across the NHS.~      Proposed study:~      Researchers in Nottingham have shown MRI can be used as an accurate marker of portal pressure~     with just one scan. To be useful to patients, doctors and researchers, this study will~     investigate whether MRI can detect meaningful changes in portal pressure after treatment with~     beta-blockers. This study has been designed with patient and public involvement (PPI)~     integrated throughout. A focus group shaped the study design and committed to collaborate in~     developing patient materials, recruitment, retention and dissemination.~      All patients who have HVPG will be given information about the study.~      Study Visit 1~        -  One hour MRI scan~        -  Endoscopy to identify varices~             -  If varices are present the patient will be started on beta-blockers and invited to~               visit 2~             -  If there are no varices, patients will return to regular follow up with the liver~               team~      Study Visit 2 (after one week)~        -  Assess side effects, blood pressure and pulse~        -  Increase dose of beta-blocker as appropriate~      Study Visit 3 (after 4-12 weeks)~        -  One hour MRI scan~        -  Repeat HVPG measurement~      Treatment success is determined by the second HVPG measurement. If beta-blockers are working~     they will be continued. If not, the patient will have treatment with endoscopy. This~     represents the ideal pathway which is more personalised than current standard care.~   "
34514|NCT03114800|"~     The goal of this work is to develop and test an automated movement detection monitoring tool~     that could lead to reduced burden on clinicians and in-turn reduce pressure ulcer incidence~     rates. Ten healthy participants will perform video-recorded bed movements while weight~     distribution and interface pressures at bony prominences on the pelvis are recorded.~   "
34515|NCT03114787|"~     Respiratory physiotherapy is not routinely prescribed in the resuscitation department and few~     studies deal with this subject, especially in respiratory resuscitation~   "
34516|NCT03114774|"~     The bispectral index (BIS) monitoring is an EEG-based method that uses electroencephalogram~     analysis and a complex algorithm to generate a numerical scoring 0-100 (0 flat line EEG, 100,~     wide awake) BIS monitoring allows noninvasive, objective measurement of level of~     consciousness of a sedated patient. A limited number of studies have used measurements of BIS~     monitoring to assist endoscopic sedation.There are studies using BIS monitoring to make~     sedation easy for ERCP procedures. However, the studies evaluating use of BIS for~     gastrointestinal endoscopy show inconsistent results.~      The objective of this study is to evaluate effects of sedation on the dosage of propofol by~     monitoring with BIS values, hemodynamics, recovery parameters, respiratory functions and~     endoscopist satisfaction based on the hypothesis that the investigators would reduce the risk~     for respiratory depression using minimal doses of propofol in order to achieve the desired~     level of sedation with BIS monitoring.~   "
34529|NCT03114605|"~     The physical, emotional, economic and social damage of stress in the police corporation~     indicates an urgent call for preventive programs to approach stress reduction, burnout~     symptoms and promotion of quality of life and well-being.~      The aim of the POLICE study is to evaluate the effectiveness of a Mindfulness-based~     intervention (MBI), compare to a waiting list (WL), in promoting quality of life and mental~     health in police officers.~   "
34530|NCT03114592|"~     This study is looking to improve the safety of patients with acute kidney injury via~     education provided on a mobile tablet. This study will additionally examine if electronic~     tools, such as mobile tablets, can help.~   "
34708|NCT03112265|"~     The study will compare the impact of Child STEPs versus usual school-based therapy on neural~     and companion behavioral measures of self-regulation.~   "
34709|NCT03112252|"~     App-based study of allergy patients under medication in the pollen season to determine the~     effect of allergic rhinitis on the quality of life.~   "
34517|NCT03114761|"~     Introduction: Morbid obesity, defined as a body mass index (BMI) of over 40 kg/m2, is~     globally an imminent health threat. Conservative therapies do often not yield the desired~     result. Bariatric surgery includes several interventions that are performed on patients with~     morbid obesity, like gastric bypass surgery. The number of bariatric surgeries annually is~     estimated to be around 500,000 worldwide; about half of these are gastric bypass surgeries.~     In the Netherlands, the most common performed bariatric intervention is the Roux-en-Y gastric~     bypass (RYGB). An important long-term complication of this surgery is internal herniation, a~     condition in which a part of the GI tract is herniated through an opening in the mesentery~     made during RYGB surgery. Incidence of internal herniation is 1-5%. Conventional abdominal CT~     examination is often not conclusive about the presence of internal herniation. When internal~     herniation is clinically highly suspected after abdominal CT examination (but not necessarily~     confirmed), the patient is subjected to diagnostic laparoscopic surgery. Unfortunately, a~     negative abdominal CT scan does not exclude internal herniation in all patients. This pleads~     for the development or exploitation of alternative techniques that might aid in the diagnosis~     of complications after RYGB surgery. Since the anatomy of GI tract is altered when internal~     herniation is present, visualizing the mesenteric vasculature may aid in the diagnosis of~     this complication after RYGB surgery. This study aims to confirm the feasibility and~     superiority of diagnosing internal herniation using CT examination of the mesenteric arteries~     over conventional CT examination.~      Objectives: The primary objective is to determine whether abdominal arterial CT angiography~     is a feasible technique for diagnosing internal herniation after RYGB surgery. Secondary, it~     is examined whether arterial angiography of the mesentery is superior over conventional CT~     examination with oral and IV contrast in the venous phase.~      Study design: This study will be a prospective pilot study, in which the outcomes of both the~     conventional CT examination and abdominal angiogram are compared to the outcome of diagnostic~     laparoscopy as gold standard.~      Study population: Patients will be included who underwent laparoscopic RYGB surgery at least~     half a year earlier and have persisting abdominal pain. They should be highly suspected for~     internal herniation by their doctor, based on several characteristics.~      Main study parameters/endpoints: Primary study endpoints are the assessments of the arterial~     abdominal angiogram and mesenteric arterial mapping in relation to the outcome of the~     diagnostic laparoscopic surgery in 12 subjects.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: In this pilot study, study subjects will receive an additional effective~     radiation dose of about 10 mSv. On average, an acute dose of 10 mSv leads to an additional~     risk of cancer of about 1 in 1750 (~1 in 2000 for males, ~1 in 1500 for females) for a~     50-year old subject, based on the linear no threshold model. However, when the mesenteric~     artery mapping proves to be feasible and superior, many unnecessary diagnostic laparoscopic~     surgeries will be prevented (along with their complications and risks).~   "
34518|NCT03114748|"~     This protocol aims to develop the use of behavioral and electroencephalographic measures~     during cognitive tasks in patients treated with deep brain stimulation during the stimulation~     parameters adjustments. The main clinical goal of this protocol is to find behavioral and or~     electroencephalographic markers to evaluates the right targeting of stimulation electrodes.~     On the more fundamental point of view, the study of those data can be used to understand~     better the action mechanisms of deep brain stimulation.~   "
34519|NCT03114735|"~     The objective of this study was to detect whether preoperative anxiety and pain sensitivity~     had effects on the consumption of anesthetics, time to achieve desired level of sedation,~     patient and endoscopist satisfaction, and postoperative recovery time and pain in deep~     sedation.~   "
34520|NCT03114722|"~     This study is a prospective, randomized, non-blinded study. 1 group will be assigned the~     standard arm with use of heparinised saline (10U/ml) lock in between each catheter use. This~     is consistent with the standard procedure of PICC care in the investigators' centre. The~     second group will be assigned the intervention with use of 4% citrate lock (Dirinco~     Citra-Lock 4%) in between each catheter use.~   "
34521|NCT03114709|"~     Physical inactivity has reached pandemic proportions and is associated with increased~     morbidity, mortality, and healthcare costs. Of particular concern is that most middle to~     older age adults fall far short of recommendations for health enhancing physical activities.~     This research takes a novel approach to tackling this problem by combining mindfulness with~     behavioral strategies in a unique 'Mindful Movement' program offered through YMCA community~     facilities.~   "
34522|NCT03114696|"~     The objective of this pilot clinical trial is to evaluate the potential of IQP-AO-101 with~     respect to sleep-promoting effects in subjects with sleep complaints.~   "
34523|NCT03114683|"~     The study is to evaluate ORR, CR, PR DCR DOR PFS and safety of IBI308 in treatment of~     patients with Relaspsed/Refractory Hodgkin's Lymphoma.~   "
34524|NCT03114670|"~     Patients with acute myeloid leukemia(AML) recurred after the allogeneic hematopoietic stem~     cell transplantation (allo-HSCT) have a dismal prognosis.The investigators developed~     donor-derived chimeric antigen receptor modified-T cell(CART) to target CD123 for the~     treatment of AML. The investigators start the Phase I study aimed to treat recurred~     post-transplantation AML patients using donor-derived CAR-T. The purpose of this study is to~     assess the safety and effectiveness of anti-CD123 CAR-T cells in patients.~   "
34525|NCT03114657|"~     This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the~     efficacy and safety of crenezumab versus placebo in participants with prodromal to mild AD.~     Participants will be randomized 1:1 to receive either intravenous (IV) infusion of crenezumab~     or placebo every 4 weeks (q4w) for 100 weeks. The primary efficacy assessment will be~     performed at 105 weeks. The participants who do not enter open-label extension will enter for~     a long term follow-up period for up to 52 weeks after the last crenezumab dose (Week 153).~   "
34526|NCT03114644|"~     Observations of the early interactions between the infant and his parents highlighted the~     existence of rhythmic and reciprocal communications that serve as a basis for the mother-baby~     relationship and the emotional and cognitive development of the baby. In this study, the~     investigator proposes to focus on premature births (before 37 years) because prematurity~     disrupts the synchronization of these mother-baby communication. For several years, reading~     of stories and nursery rhymes has been used by the liaison child psychiatry team in the~     neonatal medicine and pediatric intensive care unit of the University Hospital of Amiens, as~     a therapeutic mediation tool allowing And support for parent-child interactions. Thus, it is~     desirable to explore the impact of reading stories and rhymes on mother-baby synchronies. The~     study is innovative because it simultaneously explores several fields: physiological,~     neuroendocrine, cognitive and psychic. A pilot study carried out in 2013 showed the~     feasibility of this exploration in the three protagonists of the interaction: mother, preterm~     baby and reader.~   "
34527|NCT03114631|"~     The trial evaluates the safety and efficacy of MUC-1/WT-1 peptide and/or tumor lysate-pulsed~     dendritic cell Immunotherapy for the patients with pancreatic cancer~   "
34528|NCT03114618|"~     Venous thromboembolism (VTE) is a common disease in cancer patients and one of the major~     causes of cancer-associated mortality. Risk for developing VTE increases when cancer patients~     are receiving chemotherapy. Current risk scores for predicting cancer-associated VTE in~     ambulatory patients had low/moderate discrimination and clinical sensitivity. These models~     use clinical and biochemical parameters of the patient.~      In the development of VTE genetics play a relevant role. The product Thrombo inCode (TiC)~     assess VTE risk prediction by using a combination of a genetic risk score (GRS) and clinical~     parameters from the patient. The investigators hypothesized that the GRS included in TiC~     combined with clinical parameter some of them associated with cancer could be better~     predicted by TiC than by current risk scores (Khorana score).~   "
34531|NCT03114579|"~     Continuous perioperative cardiac output (DC) and blood pressure (PA) monitoring contributes~     to hemodynamic stability and ensures adequate perfusion pressure, resulting in a reduction in~     morbidity and mortality and length of hospital stay.~      The monitors usually used in perioperative are either semi-invasive and difficult for~     calibration (oesophageal Doppler) or invasive (arterial catheter).~      The Nexfin HD allows these two measurements and it is completely non-invasive, remains to~     validate its use in peroperative.~   "
34532|NCT03114566|"~     The purpose of this study is to obtain lymphocyte collections from normal healthy volunteer~     donors in order to create Good Manufacturing Practice grade banks of virus-specific and~     tumor-reactive T-cells of defined HLA type and restricting HLA allele readily available for~     therapeutic use.~   "
34533|NCT03114553|"~     The purpose of this study is to better understand the linkages between family health history~     (FHH) and genomics in a Singaporean population. Secondly this study will evaluate the~     facilitators and barriers to implementation of a family history collection and risk~     assessment tool within a Singaporean population.~   "
34534|NCT03114540|"~     A Phase 1, multiple center, nonrandomized, open-label, parallel group study of a single oral~     dose of GBT440 administered in subjects with mild (Child-Pugh A), moderate (Child-Pugh B), or~     severe (Child-Pugh C) hepatic impairment disease and healthy subjects with normal hepatic~     function.~   "
34535|NCT03114527|"~     This is a two center, 2 arm, Phase II study evaluating the combination of Ribociclib and~     Everolimus in patients with advanced DDL and LMS who have had at least 1 prior systemic~     therapy. Patients will be enrolled by sarcoma histology into DDL (Arm A) and LMS (Arm B). The~     purpose of this study is to determine the anti-tumor activity of this doublet therapy in~     these patient cohorts. Ribociclib will be administered orally at 300 mg/day 3 weeks on/1 week~     off. Everolimus will be administered 2.5 mg orally on a continuous 28 day cycle. Clinical and~     laboratory assessments will be made on day 1, d15 of cycle 1 and 2, and day 1 of each~     subsequent cycle. Tumor response will be assessed by RECIST 1.1 at (CT or MRI) at week 8, 16,~     24 and every 12 weeks thereafter. Study drug administration will continue until disease~     progression, unacceptable toxicity or withdrawal of consent. Patients will be followed until~     death or are lost to follow-up for analysis of secondary endpoints.~      There will be a 1 step registration process for dedifferentiated liposarcoma patients while~     patients with leiomyosarcoma will require a 2 step registration process. For step 1 of~     registration, patients must meet all the eligibility criteria necessary for step 1. For step~     2 registration, patients must meet the inclusion criteria necessary for step 2 to be enrolled~     into the study.~   "
34536|NCT03114514|"~     10 ml of blood from each patient will be drawn. This blood specimen will be centrifuged in a~     specific way to get 1 ml of platelet rich plasma (PRP). PRP will be injected into the the~     skin under the eyes. The treatment course consists of three sessions of PRP injections with~     one-month intervals between the sessions.~   "
34537|NCT03114501|"~     Objectives:~      Primary Aim:~      Examine the feasibility of a dyadic yoga program in 40 Head and Neck Cancer (HNC) patients~     undergoing radiotherapy (RT) and their family caregivers.~      Secondary Aims:~      1. Establish the initial efficacy of the yoga program in patients and their caregivers~     regarding quality of life (QOL) outcomes (i.e., fatigue, sleep disturbance, depressive~     symptoms, and overall QOL) and objective performance outcomes (i.e, sit to stand test and~     grip strength).~   "
34538|NCT03114475|"~     This study aims to evaluate the clinical effect of CO2 laser on enamel resistance to white~     spot lesions formation around orthodontic brackets.~      25 patients needing fixed orthodontic treatment will participate in the study, the CO2 laser~     will be applied in a split mouth design around orthodontic brackets in two contrast quarters~     of mouth in every patient and the other quarters will serve as a control. The white spot~     lesion formation will be monitored around the brackets during the orthodontic treatment after~     four and twelve weeks of irradiation with laser.~   "
34539|NCT03114462|"~     The goal of this clinical research study is to find the highest tolerable dose of~     stereotactic hypofractionated radioablation (HYDRA) radiation that can be given to patients~     with laryngeal cancer. The safety of this radiation will also be studied.~   "
34540|NCT03114449|"~     Aim of the study To investigate whether auricular acupuncture (AA) will reduce postoperative~     pain and analgesic requirement in comparison with sham AA in patients after elective knee~     arthroplasty~      Design Prospective randomized controlled blinded clinical trial~      Participants:~        -  Patients < 80 und > 50 years old~        -  scheduled for knee arthroplasty under general anesthesia with < 120 minutes duration~        -  Without previous opioid medication~        -  Able to give informed consent~      Outcome measures~        -  Postoperative analgesic requirement~        -  Incidence of side effects~        -  Physiological parameters~   "
34541|NCT03114436|"~     This is a 1-year national prospective cohort study that observes the medical management of~     consented deceased organ donors at hospitals across Canada with a high volume of deceased~     donation.~   "
34542|NCT03114423|"~     The purpose of this clinical study is to examine the established, therapeutic EMDR~     intervention for patients with substance use disorders (SUD). The EMDR method is an~     integrative and structured therapeutic method which assumes that memories which have been~     dysfunctionally stored can lead to harmful behavior. The EMDR protocol used for this clinical~     trials has been specifically developed for patients with SUD - the results should be compared~     with traditional therapy. For the assessment of the EMDR treatment some questionnaires are~     given at several times.~   "
34554|NCT03114267|"~     Autoimmune diseases represent a heterogeneous group of pathologies whose etiopathogenic~     mechanisms are most often unknown. Autoimmune diseases are the leading cause of morbidity and~     mortality in young women and autoimmune thyroid diseases are the most common.~      Viral infections are the main environmental factors suspected of triggering autoimmune~     diseases. Several viruses are certainly involved, all of which are possibly capable of~     triggering an autoimmune response. However, the precise identification of the viruses~     involved remains to be established.~      It has been shown for the first time by the 2005 PHRC that enteroviral RNA is present in~     perioperative specimens of thyroid tissue. However, this case-control study did not show any~     difference between the thyroid group and the group other thyroid pathologies It has been~     recently published that Parvovirus is possibly involved in thyroiditis: the parvoviral genome~     is present in the thyroid tissue of Hashimoto thyroiditis operated and more precisely is~     present within the thyrocytes itself.~   "
34543|NCT03114410|"~     This study uses a cluster-level randomized controlled design to evaluate the efficacy of~     Re:MIX in reducing the incidences of early sexual behavior, unprotected sex, oral sex,~     pregnancy, and STIs. Re:MIX is a comprehensive in-school health curriculum and teen pregnancy~     prevention program for adolescents covering a broad range of topics related to sexual health~     and youth development, including healthy relationships, communication, gender, consent,~     reproductive anatomy, contraception, sexual decision making, clinics, parenthood, and life~     planning. Re:MIX also aims to connect students and peer educators with community resources~     and service linkages. The Re:MIX curriculum teaches mixed-gender groups of students in grades~     8 to 10 to delay sex and use protection if they have sex. A co-facilitation team of peer~     educators (who are young parents) will deliver the information with professional health~     educators using non-traditional approaches, such as game-based tools, technology, and~     storytelling. Youth receive roughly nine hours and 10 minutes of group sessions during the~     school day over one semester (55 minutes per week for 10 weeks). Participants will be 8th,~     9th, and 10th graders attending three public charter schools in Travis County, Texas.~     Comparison classes will either receive an alternative program that focuses on health,~     nutrition, and fitness, or business as usual. This study is being conducted as a Rigorous~     Evaluation of New or Innovative Approaches to Prevent Teen Pregnancy funded by the U.S.~     Department of Health and Human Services' Office of Adolescent Health.~   "
34544|NCT03114397|"~     In this multicentric double-blind sham controlled study, the investigators plan to assess the~     effects of 20 sessions of tDCS on long-term behavioral recovery in patients with disorders of~     consciousness. Neurophysiological outcomes (EEG) will also be collected.~      This research will 1) determine whether long-term behavioral recovery can be promoted with~     tDCS and 2) generate knowledge regarding the impact of tDCS on neurophysiological outcome~     (i.e., EEG) in severely brain injured patients. The investigators will compare the effects of~     active and sham tDCS on behavioral assessments and quantitative EEG in patients with severe~     brain injury and its potential application in rehabilitation.~   "
34545|NCT03114384|"~     Fifteen healthy subjects under non-invasive ventilation will be have a recording of surface~     electromyogram, measurements of airway flows and pressures as well as a continuous~     ultrasound. The provocation of leaks on the Ventilation circuit and expiratory trigger~     modulation will generate a number of asynchronies between the subject and the respirator.~      These records will help to assess the agreement between the detection of asynchronies using~     electromyography of the respiratory muscles (technique of reference) and the diaphragmatic~     echography. We will also compare the respective performance of two techniques of~     diaphragmatic exploration (excursion and thickening of the diaphragm). A sensitivity of~     Ultrasound technique of at least 90% will be interpreted as a satisfactory index of~     concordance.~   "
34546|NCT03114371|"~     Positive results in preclinical and clinical studies in adults and infants with Prader-Willi~     syndrome lead investigators to set up a new study in children with Prader-Willi syndrome. The~     objective of this study is to document effects of oxytocin intranasal administrations on~     behavioural troubles in children with Prader-Willi syndrome aged from 3 to 12 years.~   "
34547|NCT03114358|"~     Early de-escalation of carbapenems can reduce unnecessary use of carbaepenems compared with~     late de-escalation without compromised clinical outcomes~   "
34548|NCT03114345|"~     Paraplegic patients have defective wound healing for sore below the level of spinal lesion.~     Defect of vascularization of the healing zone certainly participate to this effect.~     Therefore, this study want to measure, in a clinical settings, the interface pressure (e.g.~     the pressure between the patient body and the surface he/she is lying on) to assess the~     correlation between mechanical stress in term of pressure applied over time and tissue~     oxygenation which represent micro-vascular function. The aim of this clinical trial is to~     correlate the variations of pressure intensities and changes in micro-vascularization. The~     measure are recorded when paraplegic patient came into the hospital for pressure ulcer~     related surgery. The patient is laying on his/her mattress on top of a flexible pressure~     mapping device. The micro-vascularization parameters are measured at the area displaying the~     peak pressure a few minutes after the beginning of the pressure interface recording and one~     hour later at the same area. The data generated during this monocentric study will help to~     achieve a better understanding of the relation between pressure and micro-vascularization. In~     the mid term, it will provide a better and more patient adapted pressure ulcer prevention.~   "
34549|NCT03114332|"~     A randomized controlled trial that aimed at studying the values (if any) of subcutaneous~     drains use in lean women during Cesarean section.~   "
34550|NCT03114319|"~     The purpose of this first in human (FIH) trial is to characterize the safety and tolerability~     of the SHP2 inhibitor TNO155 and identify a recommended dose for future studies in adult~     patients with advanced solid tumors in selected indications.~   "
34551|NCT03114306|"~     Mobilisation following knee arthroplasty is an important aspect to achieve early and enhanced~     recovery after surgery and sufficient joint function. Analgesia is a crucial therapeutic~     element in this context. This RCT evaluates two analgetic regimens for patients undergoing~     primary total knee-replacement to assess impact on postoperative recovery.~   "
34552|NCT03114293|"~     Due to their ubiquitary distribution, smartphones might serve as an easy way/ possibility to~     use feedback mechanism in an app-based intervention program to increase physical activity in~     Multiple Sclerosis (MS) patients. Internet based cognitive-behavioral interventions have been~     explored as effective in the last years. In addition, smartphone-based mobility assessment~     and intervention might be a promising approach in other MS types and for real-life mobility~     assessment in observational and interventional trials. The aim is to investigate the impact~     of a smartphone based information and feedback program on physical activity in a 3 months,~     randomised waiting-group controlled trial of 40 progressive MS patients.~   "
34553|NCT03114280|"~     Non-randomized phase II, open-labeled clinical study, multicenter, of docetaxel (T),~     cisplatin (P), 5 fluorouracil (F) and pembrolizumab every 21 days followed by radiotherapy~     (RT) combined with carboplatin in untreated unresectable locally-advanced Head and Neck~     Squamous Cell Carcinoma (HNSCC).~      The TPF and pembrolizumab combination will be called TP²F.~   "
34555|NCT03114254|"~     An evaluation of the activity of cabazitaxel chemotherapy in relapsed cancer of the penis.~     Safety and tolerability will be monitored and survival will be assessed. It is hypothesised~     that cabazitaxel is useful in increasing progression free survival in relapsed penile cancer.~   "
34557|NCT03114228|"~     The purpose of this study is to gather and evaluate additional safety data on the combination~     of midostaurin and standard of care for adult patients with newly diagnosed Fms-like tyrosine~     kinase receptor (FLT3) mutated Acute Myeloid Leukemia (AML) who are eligible for standard~     induction and consolidation chemotherapy and are without satisfactory treatment alternatives~     prior to the commercial availability* and reimbursement of midostaurin during the regulatory~     approval process~   "
34558|NCT03114215|"~     This is a 6-month double blind randomized 2:1 placebo-controlled study with two arms~     (placebo, biotin 300 mg/day). The study will be followed by a 6-month extension phase during~     which all patients will receive biotin 300 mg/day.~   "
34559|NCT03114202|"~     This study investigates the effects of nutritional counseling versus standard nutritional~     care on nutritional status and quality of life in patients with head and neck cancer~     submitted to radiotherapy.Half participants will receive intensive nutritional counseling~     while the other half will receive standard care.~   "
34560|NCT03114189|"~     The purpose of this study is to ascertain whether warm footbathes are effective on sleep~     disturbances in women before climacteric.~   "
34561|NCT03114176|"~     Overweight divers face a challenging activity such as immersions, starting from a higher~     levels of circulating cytokines and oxidative stress. Ketogenic Diet (KD) is described as~     effective in weight loss, in countering inflammation and oxidative stress, and used in the~     control of drug-refractory seizures.~      The aim of our pilot study was to evaluate if a ketosis state induced by a specific dietary~     regime, may have a protective effect on oxidative stress damages and inflammatory status,~     that accompanies both overweight and diving activities.~      Blood and urine samples from six overweight divers were obtained a) before (CTRL) and after a~     dive breathing Enriched Air Nitrox and performing light underwater exercise (NTRX), b) after~     a dive (same conditions) performed after 7 days of KD (K-NTRX). We measured urinary~     8-isoprostane and 8-OH-2-deoxyguanosine evaluating lipids peroxidation and DNA oxidative~     damages. Plasmatic IL-1beta, IL-6 and TNF-alpha levels were measured to investigate the~     inflammatory status.~   "
34562|NCT03114163|"~     This is an observational study in adult patients in Germany diagnosed with SCCHN progressing~     on or after platinum-based therapy, who start a new systemic therapy with nivolumab for the~     first time, and are treated within the market authorization approval. Patients are to be~     enrolled into the study no earlier than the decision to initiate treatment with nivolumab and~     no later than the first dose of nivolumab treatment.~   "
34563|NCT03114150|"~     Given the accelerating growth of older adults worldwide and the decline in cognitive function~     with aging, therapeutics that remediate age-related cognitive decline are needed more than~     ever. The proposed research seeks to better understand and enhance the detection of exercise~     effects on hippocampal network function and learning and memory, which decline with aging and~     Alzheimer's. Success would lead to new ways to detect benefits of exercise on cognitive aging~     and would lead to mechanistic insight on how such plasticity is possible while also informing~     prevention strategies.~   "
34564|NCT03114137|"~     The CADRE study is a multinational observational cohort of patients with sickle-cell disease~     (SCD) in five west and central sub-Saharan African countries. The aim of this project is to~     describe the incidence and assess the predictive factors of SCD-related micro- and~     macro-vascular complications in sub-Saharan Africa.~   "
34565|NCT03114124|"~     The aim of our study is to investigate the comparative efficacy of high fidelity multi~     electrode ablation catheters vs the standard bipolar configuration in success of AV nodal~     ablation This study will provide insights on the use of new technology where application may~     increase efficacy, promote patient and physician safety and decrease costs.~   "
34566|NCT03114111|"~     The purpose of this study is:~        1. To determine the efficacy of photodynamic therapy (PDT) in the treatment of seborrheic~          dermatitis.~        2. To determine how PDT alters the skin microbiome in subjects with seborrheic dermatitis~          before and after treatment.~        3. To determine how PDT alters sebum secretion rates in subjects with seborrheic dermatitis~          before and after treatment.~      The researchers hypothesize that PDT will be efficacious in the treatment of seborrheic~     dermatitis.~   "
34567|NCT03114098|"~     Psychotropic drugs are frequently used in children and adolescents in France with a~     prescription rate of 2.5%. Antipsychotics (PA) and antidepressants (AD), each concern 0.3% of~     the pediatric population (Kovess et al., 2015). Despite appropriate pharmacological~     treatment, some patients are drug-resistant and have persisting symptoms and ineffective~     psychotropic treatments. These children and adolescents are generally exposed to many~     psychotropic molecules and often to poly-therapy.~      Most psychotropic treatments, especially AP and AD, are metabolised at the hepatic level by~     cytochrome P450 and in particular by CYP2D6. Duplication / multiplication of the CYP2D6 gene~     induces too rapid metabolism of drugs.~      Demonstration of a CYP2D6 abnormality has a direct impact on the management of the patient~     and on the clinical decisions of the clinician. Thus, knowledge of individual metabolism will~     decrease the failure of treatment, improve quality of life and therapeutic compliance.~   "
34568|NCT03114085|"~     It is an open,randomized,controlled study, and the purpose of this study is to observe and~     evaluate the efficacy and safety of Apatinib combined with Capecitabine in the treatment of~     patients with advanced hepatocellular carcinoma.~   "
34569|NCT03114072|"~     Sleep disturbances are common in pregnancy, and the incidence increases during the third~     trimester. Light and specially the blue wavelengths of light, is affecting sleep and the~     circadian rhythm. The main aim of this randomized controlled study is to investigate the~     effect of Blue-blocking glasses (BB-glasses) used in the evening and night on sleep and mood~     in pregnant women in the third trimester. The outcome measures assess sleep variables,~     alertness, melatonin level, sleepiness (subjectively), mood and symptoms of anxiety and~     depression. In addition we want to measure the pregnancy related sleep problems, alcohol~     intake, physical activity and perceives stress in the study population, and the association~     with daily/nightly light exposure.~   "
34570|NCT03114059|"~     This study evaluates the results of all clinically relevant findings of glaucoma diagnostics~     5 Years after stent-implantation concerning the safety and effectiveness of the cypass stent~     procedure. The comparison of Preoperative and long term postoperative results is the aim of~     this study to evaluate this young procedure of Glaucoma surgery~   "
34571|NCT03114046|"~     The purpose of this single-subject, concurrent mixed methods study is to investigate the~     relationship between the effect of the CIMT protocol on gait and mobility and participants`~     and caregivers` expectations and perceptions regarding the treatment. The goal of the~     quantitative strand is to assess changes in quality of movement and functional use of the~     paretic lower limb after the treatment and investigate the participants` expectations in~     regards the intervention using the Participant Opinion Survey (POS). The qualitative strand~     (participant interviews) will determine perspectives of caregiver and participant~     perspectives regarding protocol acceptability. Both quantitative and qualitative data will be~     collected and analyzed concurrently, through triangulation and complementarity rationales;~     both data will be equally prioritized.~   "
34572|NCT03114033|"~     The TAME Cardiac Arrest trial will study the ability of higher arterial carbon dioxide~     (PaCO2) levels to reduce brain damage, comparing giving patients 'normal' to 'slightly higher~     than normal' blood PaCO2 levels and assessing their ability to return to normal life-tasks.~     It will be the largest trial ever conducted in heart attack patients in the intensive care~     unit. This therapy is cost free and, if shown to be effective, will improve thousands of~     lives, transform clinical practice, and yield major savings.~   "
34573|NCT03114020|"~     The purpose of the study is to evaluate the safety and efficacy of administering repeated~     doses of Hyaluronic Acid Inhalation Solution to subjects with Emphysema that have~     Alpha-1-Antitrypsin deficiency~   "
34574|NCT03114007|"~     Mental health problems affect 10-20% of children and adolescents worldwide, with half of~     affected youth experiencing problems by the age of 14. Despite the early onset of mental~     health problems, evidence-based prevention and early intervention programs remain scarce. If~     left untreated, early-onset mental health problems can progress to become severe or chronic~     conditions, and incur significant medical and societal costs.~      The current project proposes an integrated screening and intervention model that was~     developed involving active youth, family and community engagement. This project, known as~     Inter-Venture, focuses on reducing barriers to youth mental health care and promoting early~     screening and intervention by fostering collaboration between school and community-based~     services providers. The Inter-Venture project is being conducted in the Montreal area~     (Canada), and consists of three intervention modalities. Namely, 1) systematic school-based~     screening and personality-targeted interventions for students most at risk of mental health~     problems and substance misuse (the Preventure program); 2) a parent program designed to~     strengthen parenting skills and to improve the management of child behavior problems~     (Cope/EQUIPE program); 3) integrated services provided by a multidisciplinary team of~     professionals (referred to as Inter-Action) for youth with significant symptoms of mental~     health problems, substance misuse and/or psychosocial difficulties. The intervention model~     involves knowledge transfer to boost capacity-building and improve the provision and~     sustainability of evidence-based interventions in community settings.~      The primary goal of the Inter-Venture trial is to assess the potential effect of the~     school-based targeted interventions and collaborative care in the prevention, early detection~     and reduction of mental health problems, substance misuse and psychosocial difficulties among~     young people. The secondary goal is to assess the effect of interventions on school~     performance and whether the interventions can protect cognitive functions that may be~     negatively affected by early-onset substance use and mental health problems, and promote~     cognitive development through the prevention of these difficulties.~   "
34575|NCT03113994|"~     Rationale: After having a spinal cord injury (SCI), people develop changes in their body~     composition that influences their long-term health. Individuals with paralysis after SCI will~     have large declines in their bone density ant increases in fat mass which increases their~     risk of fracture and heart disease. Therapies to prevent SCI-related changes in body~     composition and their health effects are needed. Drugs known as statins used often to~     reduce high cholesterol, may help to reduce bone loss and inflammation.~      Hypothesis: Among adults with SCI for a long time, treatment with a drug named Rosuvastatin~     or a sugar pill, with supplements (coenzyme Q10, calcium and vitamin D), for twelve months~     can decrease their endocrine metabolic disease risk by increasing bone density and reducing~     inflammation.~      Study Design: A clinical trial will be conducted in Toronto, Ontario and Miami, Florida.~     Subjects will get statin therapy or placebo (sugar pill) by chance. Study subjects and~     research staff will not know whether they are taking the study drug or a sugar pill until~     after the study~      Subjects: Fifty-four adults (age 18-60 years) with a long-term SCI and no movement below~     their level of injury.~      Treatment: Subjects will be prescribed Rosuvastatin 10 mg daily or a sugar pill. In addition,~     all subjects will receive 100 mg of Co-Q10 daily, calcium carbonate 1250 mg and, vitamin D~     2,000 IU once a day.~      Data Collected: Subjects' bone density will be collected at the start and end of the study.~     Change in bone density between the two groups will be compared to see if one is better. Blood~     samples will be collected quarterly to make sure subjects are safe and do not develop~     problems with their liver or muscles and to measure the effects of the study drugs on~     inflammation throughout the body.~      Clinical Implications: Statins may be safe and effective therapy for adults living with SCI~     who are at increased risk of endocrine metabolic disease as they age.~   "
34576|NCT03113981|"~     The infection rate after Total Hip Arthroplasty (THA) is about 1%. It is a serious condition,~     with high morbidity, sometimes fatal, requiring costly treatment.~      The treatment is difficult because biofilm forms very early after the bacterial~     contamination of the prosthesis.~      Prevent infection means reduce or prevent the formation of bacterial biofilm and controlling~     protein response to allow osseous-integration of the prosthesis.~      A new prosthesis was developped, grafted by PolyNaSS (polysodium styrenesulfonate). This~     bioactive polymer allows to substantially reduce bacterial adhesion, biocompatibility,~     bio-integration in preclinical studies. This first clinical study aims to compare the~     osseous-integration of this prosthesis to the same prothesis with no grafting.~      No previous clinical trial~   "
34577|NCT03113968|"~     The goal of the study is to conduct a comparative randomized trial of electroconvulsive~     therapy (ECT) vs. ketamine for patients with treatment resistant depression (TRD) in a real~     world setting with patient reported outcomes as primary and secondary outcome measures.~   "
34578|NCT03113955|"~     A Single-arm Trial of Transcatheter Arterial Chemoembolization with Tandem Microspheres in~     the Treatment of Localized Hepatocellular Carcinoma~   "
34579|NCT03113942|"~     This is a single centre open label phase II trial to determine the antitumor efficacy of the~     oral immunomodulatory agent pomalidomide in persistent human papillomavirus (HPV) -associated~     high grade squamous intra-epithelial lesions (HSIL) in patients with and without human~     immunodeficiency virus (HIV) infection.~   "
34592|NCT03113773|"~     The mainstay for treatment for acute coronary syndrome (ACS) focusses on re-establishing and~     maintaining the patency of vessels following coronary plaque disruption, through the use of~     anti-platelets and anticoagulants. Despite advances in management ACS still carries a high~     risk of morbidity and mortality, thus future management is likely to target other pathways.~      Recent studies indicate that CD4+ T cells, and more specifically Treg cells, are important~     for the control of post-ischemic immune responses and the promotion of myocardial healing.~     The investigators therefore hypothesise that expansion of Treg cells in patients with ACS~     dampens the activation of the immune response and promotes both plaque and myocardial~     healing. The investigators hypothesise that this can be achieved through subcutaneous~     administration of low doses of interleukin-2 (IL-2). IL-2 supplementation appears to be an~     attractive therapeutic option playing a key role in Treg cell development, expansion,~     survival and suppressive function.~   "
34710|NCT03112239|"~     The objective of this study is to evaluate the effects of LED phototherapy associated with a~     resistance training protocol on the peripheral muscle function of moderate to severe~     asthmatic patients ..~   "
34580|NCT03113929|"~     The current goal in the treatment of Alcoholic Liver Disease (ALD) is to manage~     ALD-associated complications as there are no disease-specific therapies. Identifying~     disease-specific therapies to slow ALD progression is critical to improving the outcomes in~     these patients. Despite preclinical treatment studies in animal models that have shown~     promise, clinical trials in ALD patients have been limited by the absence of sensitive,~     quantitative methods for identifying severity and monitoring progression of liver disease.~     The rates of progression of liver disease in ALD are variable and difficult to predict, which~     makes assessments of therapies difficult. Clinical measures of hepatic or biliary disease~     (e.g., bilirubin, transaminases) may be normal, only mildly elevated and/or stable despite~     ongoing organ damage. Liver biopsies are diagnostic, but are invasive and are of limited~     value for longitudinal monitoring. Currently clinical imaging, including standard volumetric~     imaging (MRI and ultrasonography) and hepatic fibrosis assessment (e.g. Fibroscan) are also~     of limited utility in fully staging disease severity and monitoring progression in ALD. The~     absence of clinically available methods for accurately determining the severity and~     progression of liver disease progression in ALD has limited implementation of clinical trials~     using novel therapeutic agents. Development of non-invasive imaging biomarkers to assess~     rates of liver progression will overcome this barrier and allow for such studies to be~     undertaken. This study intends to perform a one-time MRI on patients with ALD to search for~     these biomarkers that can improve the diagnosis and treatment of ALD patients.~   "
34581|NCT03113916|"~     This pragmatic randomized clinical trial will assess the efficacy, cost, and sustainability~     of a culturally tailored weight-loss program targeting obese Hispanic women with pre-diabetes~     or T2D. The intervention will be integrated into patient care at a Federally Qualified Health~     Center serving over 30,000 low-income patients, and will be delivered by trained clinic~     staff, with minimal support from research staff. After the effectiveness clinical trial, two~     cohorts of clinic patients will receive the intervention in a sustainability test.~   "
34582|NCT03113903|"~     The Pain Sensitivity Questionnaire (PSQ) is a tool created in 2009 by Dr. R. Ruscheweyh in~     Germany. It aims at identifying the natural sensitivity to pain, through a set of 17 simple~     questions. These questions simulate daily life situations likely to induce pain of various~     intensities. The internal validity of the tool had been demonstrated both for the original~     version in German, and then for its English version. The external validity had also been~     demonstrated by correlation to real nociceptive stimulations applied to healthy volunteers~     (German version), and to patients before surgery (English version). A French validation of~     the questionnaire is needed, in order to integrate it in pain research programs in~     French-speaking countries.~   "
34583|NCT03113890|"~     This is a three month naturalistic prospective, randomized, open label study of~     pharmacogenetic testing and clinical outcomes in inpatients across diagnoses, including~     Treatment Resistant Depression (TRD) with or without Post-Traumatic Stress Disorder (PTSD),~     recruiting from the Short Term Unit at McLean Hospital.~      Specifically, the investigators will enroll 200 inpatient subjects over 2 years who will~     donate saliva/undergo a cheek swab to collect DNA for the Genecept assay. For 100 patients in~     the assay-guided group, treating Clinicians will receive the Genecept report prior to patient~     discharge and use it to guide psychoeducation and medication management. For the additional~     100 inpatients, treating clinicians will not receive the report during the patient's~     inpatient stay (treatment as usual. Clinicians will receive the assay report for patients in~     the treatment-as-usual group at the 3-month followup period. Thus this group will serve as~     the control group for the outcomes related to Genecept-guided decision making.~   "
34584|NCT03113877|"~     Based on survey data, individuals with Cornelia de Lange Syndrome (CdLS) often experience~     symptoms of autonomic dysfunction however there are no reported studies in which these~     patients have had objective testing of the autonomic nervous system. This is a pilot study in~     which patients with CdLS will undergo the standard clinical testing for autonomic dysfunction~     with a autonomic reflex screen and thermoregulatory sweat test.~   "
34585|NCT03113864|"~     Randomized, double blind, placebo-controlled intervention trial on the ocular benefits and~     inflammatory markers improvements of taking FloraGLO Lutein for 9 months. The population of~     interest is middle-aged men and women who have low levels of carotenoids in their eyes.~   "
34586|NCT03113851|"~     The purpose of this study is to determine whether radiation combined with recombined human~     granulocyte-macrophage colony stimulating factor(rhGM-CSF) is safe and effective for patients~     with metastatic non-small cell lung cancer.~   "
34587|NCT03113838|"~     This is a prospective registry study to surveil early liver injuries caused by Yangxue~     Shengfa Capsule (YXSF Capsule) through a non-intervention observational way. And attempt to~     establish a predictive model to screen susceptibilities to YXSF Capsule.~   "
34588|NCT03113825|"~     Phase 2, open-label study of AVB-620 in women with primary, nonrecurrent and nonmetastatic~     breast cancer undergoing surgery.~   "
34589|NCT03113812|"~     This first time study in humans was designed to assess tolerability and safety of repeated~     subcutaneous injections of ABvac40, an active immunization against the C-terminal end of~     Abeta1-40.~   "
34590|NCT03113799|"~     To evaluate the performance characteristics of the Smart External Drain (SED) compared with~     standard EVD drains in the hospital setting, specifically:~        -  Number, type and duration of staff interactions.~        -  Regulating and controlling ICP and CSF drainage.~        -  Maintaining system control with patient movement.~   "
34591|NCT03113786|"~     The purpose of the study is to evaluate the efficacy of CLARIX™ 100 and CLARIX™ CORD 1K as a~     tissue barrier when used as an annular patch in discectomy patients with low back & leg pain~     when compared to traditional discectomy patient outcomes. This will be a 120 patient,~     prospective randomized study model over a 5 year post-operative period.~   "
34617|NCT03113448|"~     To study that 0.075% capsaicin lotion is safe, well tolerated and provide significant pain~     relief in patients with PDN compared with placebo lotion as a randomized, double- Blind,~     crossover, placebo-controlled trial~   "
34711|NCT03112226|"~     Complaints about memory and thinking are common in women as they go through menopause. The~     female hormone estrogen is important for both the health of both the brain and the blood~     vessels. In Alzheimer's disease there is damage to the blood vessels in the brain. This study~     will look at how the loss of the female hormone estrogen affects brain function and the~     health of blood vessels.~   "
34593|NCT03113760|"~     This is a Phase 3 study to assess the safety and efficacy of Tadekinig alfa in patients with~     monogenic, interleukin-18 (IL 18) driven autoinflammation due to Nucleotide-binding~     oligomerization domain, leucine-rich repeat and caspase recruiting domain (CARD domain)~     containing 4 (NLRC4) - Macrophage activation syndrome (MAS) mutation (NLRC4-MAS mutation) or~     X-linked inhibitor of apoptosis (XIAP) deficiency. Because of the likelihood for pathogenic~     IL-18 in certain monogenic diseases, patients known to harbor deleterious mutations in~     NLRC4-MAS or XIAP and who have a history of ongoing inflammation will be enrolled if they~     have ferritin ≥ 500 ng/mL or persistent C reactive protein (CRP) elevation > 2 times the~     upper limit of normal (ULN) and the patients should have a Modified Autoinflammatory Disease~     Activity Index (mAIDAI) ≥ 4.~   "
34594|NCT03113747|"~     The purpose of this study is to evaluate safety and efficacy of tissue engineered construct~     based on allogeneic cultured adipose-derived multipotent mesenchymal stromal cells~     (ALLO-ADSCs) and platelet-poor plasma fibrin hydrogel to treat patients with 2-B and 3-~     degree burn wounds~   "
34595|NCT03113734|"~     This study develops the construction and validation of a reliable functional screening score~     in LCA ruptures in the immediate post-traumatic period.~      This score, realizable in an emergency, would be an early warning signal requiring an~     emergency consultation with an orthopedic surgeon. It would be a tool for screening acute LCA~     ruptures at a time when ligament testing maneuvers are too painful to be contributory to the~     diagnosis. It would avoid a premature return to dangerous activity for the knee with a~     rupture of the LCA.~      The other impact would be economical since it would avoid the realization of unnecessary MRI.~      On the other hand, it will allow patients with LCA rupture to have faster access to MRI. The~     hypothesis of the study is that a validated functional score would make it possible to sort~     the patients in the emergencies and to prescribe the MRI only in the cases of effective~     rupture of the LCA.~   "
34596|NCT03113721|"~     The purpose of this prospective, non-interventional, multi-centre clinical study is to assess~     the clinical validity of the Heparin Binding Protein (HBP) assay for indicating the presence,~     or outcome, of severe sepsis (including septic shock), over 72 hours, in patients with~     suspected infection following emergency department admission.~   "
34597|NCT03113708|"~     High dose heparin regimens are required in cardiac surgery under cardiopulmonary bypass (CPB)~     and this may increase postoperative bleeding. The aim of this study is to evaluate the effect~     of heparin dose calculated according to lean body weight on intraoperative and postoperative~     bleeding.~   "
34598|NCT03113695|"~     The purpose of the study is to investigate whether combination of obinutuzumab, lenalidomide,~     and high dose methylprednisolone in the treatment of Richter's Syndrome. The study will~     evaluate whether this regimen can reduce the amount of cancerous cells in your body. All of~     these agents are approved by the FDA Obinutuzumab is a protein molecule manufactured from a~     single cell population, has been approved by the Food and Drug Administration (FDA) for the~     treatment of CLL of SLL. Lenalidomide is for the treatment of patients with other blood~     cancers. Methylprednisolone is a type of steroid, and it is used in a wide variety of medical~     conditions. These agents and the combination of these agents are not approved for the~     treatment of Richter's Syndrome and are considered experimental.~   "
34599|NCT03113682|"~     The primary aim of this study is to pilot cognitive behavioral therapy (CBT-RD) for 10~     individuals ages 10 and older who have rumination disorder~   "
34600|NCT03113669|"~     The primary aim of this study is to determine how inhibitory neurobiological and~     neurocognitive processes relate to binge eating treatment outcome.~   "
34601|NCT03113656|"~     Infants with neonatal abstinence syndrome (NAS) who are cared for in a Neonatal Intensive~     Care Unit (NICU) often display symptoms including hyperactivity, irritability, jitteriness,~     poor feeding, and poor sleep patterns. The recommended first line of treatment to relieve~     these symptoms involves nonpharmacological interventions. The purpose of the current pilot~     study is to provide preliminary data to assist in the design of a larger scale study to~     examine one nonpharmacological intervention, weighted blankets. The pilot study will assess~     the feasibility of a cross-over randomized controlled design to study the impact of a~     weighted blanket on infants' symptoms of NAS.~      The aims of the study are:~      Aim1: To determine the feasibility of recruiting patients for a study evaluating the use of~     weighted blankets in the care of infants with NAS Aim 2: To determine the feasibility and~     safety of the study procedures Aim 3: To examine whether there is clinical benefit to using~     weighted blankets for the treatment of symptoms in infants with NAS.~      After informed consent is obtained, infants will be randomized to have either a weighted~     blanket or a non-weighted blanket placed on them first. A cross-over design will be used so~     all infants will experience both the non-weighted and weighted blankets. Thirty minutes~     before each feeding, baseline vital signs and Finnegan score will be obtained. Then, a~     blanket (weighted or non-weighted) will be placed on the infant for 30 minutes. Infants will~     be directly monitored and on heart rate/respiratory rate monitors while the blanket is~     applied. Vital signs and Finnegan scores will be obtained at the end of 30 minutes of blanket~     placement, infants will be fed, and vital signs and Finnegan scores will be obtained again 30~     minutes after the blanket was removed. Descriptive statistics will be used to determine the~     enrollment rate and feasibility of the protocol. Nonparametric statistics will be used to~     compare total Finnegan scores for infants with the weighted blanket applied compared to~     infants with a non-weighted blanket applied. Changes in Finnegan scores will be examined to~     estimate an effect size to use in a power analysis for a future larger effectiveness study.~   "
34602|NCT03113643|"~     This research study is studying a drug as a possible treatment for diagnosis of AML and~     high-risk MDS.~      The interventions involved in this study are:~        -  SL-401~        -  Azacitidine~   "
34603|NCT03113630|"~     Thirty individuals with ALS (18 men and 12 women, mean age 59 years, range 44-74 years), and~     30 healthy controls matched for age and gender, participated. Individuals with ALS and from~     the control group were randomly divided into three groups, each using a different~     communication device systems (Kinect®, Leap Motion Controller® or touchscreen) to perform two~     task phases (acquisition and retention). Performance was then explored in a third phase~     (transfer) by switching devices (two transfers); so that, all groups had contact with all~     communication interfaces.~   "
34604|NCT03113617|"~     This phase II trial studies how well gallium Ga 68-labeled gastrin-releasing peptide receptor~     (GRPR) antagonist BAY86-7548 (68Ga-RM2) positron emission tomography (PET)/computed~     tomography (CT) works in detecting regional nodal and distant metastases in patients with~     intermediate or high-risk prostate cancer. 68Ga-RM2 PET/CT scan may be able to see smaller~     tumors than the standard of care CT or magnetic resonance imaging scan.~   "
34638|NCT03113175|"~     The aim of the study Collabri Flex is to:~        -  Develop a Danish model for collaborative care for patients with anxiety in general~          practice, based on past experience gained in the Collabri Project.~        -  Examine the impact of this model compared with liaison-consultation for people with~          anxiety in a randomized controlled design from selected endpoints.~   "
37212|NCT03079544|"~     The purpose of this study is to collect data from patients by social media and self-report on~     the adverse events and outcomes happened with patients with extranodal natural killer/T-cell~     lymphoma, nasal type, who are treated outside of clinical trials in China.~   "
34605|NCT03113604|"~     Primary liver cancer or hepatocellular carcinoma (HCC) is the 7th most common cancer in~     humans; 9th in women (figures from the Association for Research against Cancer ARC). This~     cancer is a major public health problem on a global scale. Patients, whose diagnosis is often~     late, are at advanced stages of the pathology, even those who benefit from locoregional~     treatments have a poor prognosis and suffer from a lack of curative therapeutic strategies.~     CHC is highly refractory to cytotoxic chemotherapy and so far the response rates to~     conventional systemic chemotherapy has provided a clinical benefit where survival was~     prolonged by more than 25% in patients with advanced CHC. Further efforts are needed to~     effectively manage HCC. Knowledge of the mechanisms regulating proliferation and inhibiting~     the sensitivity of transformed cells to apoptosis is the key to the development of more~     effective therapeutic strategies.~      Several new therapies, called targeted therapies, are tested in clinical trials. Currently,~     the most effective molecular agent for targeting the Raf pathway is sorafenib capable of also~     inhibiting tyrosine kinases of VEGFR and PDGFR. Sorafenib, a multikinase inhibitor, decreases~     the proliferation of tumor cells in vitro that inhibit the activity of targets present in~     tumor cells (CRAF, BRAF, V600E BRAF, c-KIT, and FLT-3) and tumor vascularization VEGFR-2,~     VEGFR-3, and PDGFR-beta). Despite the real benefit of this treatment, its efficacy (three~     months of overall survival) and its indication remain limited to Child-Pugh A, WHO 0-2~     patients in whom curative treatment is contraindicated. In addition, several patients have~     resistance to Sorafenib and thus find themselves in therapeutic failure, thus limiting the~     therapeutic choice for these patients.~      Resistance to treatment with Sorafenib limits the therapeutic choice. The mechanisms~     responsible for this resistance remain to be elucidated. Drug resistance proteins, MDR~     Multi-Drug Resistance, is a family of molecules whose expression increases in the cancer cell~     and ensures the repression of chemotherapy molecules outside the target cancer cell. This~     family includes the proteins ABCG2, MDR and MRP1. Our in vitro studies show that treatment of~     CHC Huh-7 cells with Sorafenib (10 mM) induces the specific expression of the transcripts of~     the MRP-1 protein without any effect on the expression of the ABCG2 and MDR protein. In~     addition, sorafenib has an effect on the expression of hepatocyte SLAMF3 receptor~     transcripts, a receptor recently identified in hepatocyte tissue. Indeed, it has been shown~     that the expression of SLAMF3 is lowered in the cancerous tissue compared to the healthy~     tissue and that the reintroduction of a strong expression in the cancer cell inhibits its~     proliferation by inhibiting the MAPK Erk pathway, Cancer cells to apoptosis and inhibits the~     uptake of tumor masses in the Nude mouse (I. Marcq, et al., 2013).~   "
34606|NCT03113591|"~     Osteo introducer system is the instruments used in minimal invasive THA. This study will~     compare the minimal invasive THA using the osteo introducer system and THA using common~     instruments, to show the non-inferiority of osteo introducer system in safety and efficacy of~     THA surgery.~   "
34607|NCT03113578|"~     This is an observational registry study collecting data on the clinical performance of the~     study device (DiLumen™ ) for its intended use. The primary objective is to evaluate~     functional outcomes of the DiLumen device in humans. The secondary objective is to evaluate~     safety characteristics of the DiLumen device.~   "
34608|NCT03113565|"~     After cardiac surgery, patients' follow-up after discharge is a major public health issue.~     Since the main complications occur mostly during the first extra-hospital month, a follow-up~     period becomes necessary as the average duration of hospitalization tends to decrease. The~     resumption of normal physical activity is rarely transmitted and when complications arise,~     the healthcare team is most often informed late.~      An electronic wristband is worn by the patient during the day, between the day of discharge~     from the hospital (D0) and the end of the second extra-hospital month (D60). The data~     recorded by the wristband include : bracelet ID, date, time, number of steps per day, and~     heart rate averaged by 5 minutes.~      The primary objective of the study is to measure the resumption of physical activity after~     elective cardiac surgery. This objective will be quantified by the number of daily footsteps.~      A secondary objectives is to determine perioperative predictors of the physical resumption.~   "
34609|NCT03113552|"~     Mitral insufficiency (MI) accounts for 24% of adult valvulopathies and affects 7% of subjects~     older than 75 years. They are the second leading cause of valvulopathy in Europe. The most~     common etiology is the associated valvular prolapse. Mitral surgery remains the reference~     treatment for symptomatic MI. The success of this procedure depends on the mitral valve~     geometry and the location of the prolapse. The site of the prolapse, whether monovalvular,~     localized to the posterior or anterior leaflet, or bivalvular, influences the possibilities~     and probably the long-term results of the plasty.~   "
34610|NCT03113539|"~     We will demonstrate the validity of measurements with a low-dose, EKG-gated CT without~     contrast in the ascending aorta evaluation, compared with the current Angio-CT measurements.~   "
34611|NCT03113526|"~     This is a single-blinded randomized controlled trial to compare the outcomes of early closed~     suction drain removal versus output volume-based drain removal after selective lateral neck~     dissections (SLND). The main hypothesis of the study is that the early drain removal of~     closed suction drains on the first postoperative day is safe compared to the current practice~     of output volume-based drain removal when output is less than 30ml/24hr or 15ml/12hr. This~     study will also evaluate the hypotheses that output volume-based drain removal of surgical~     drains increases inpatient length of stay and decreases the average patient satisfaction~     score on the measurement of quality of recovery (QoR-40).~   "
34612|NCT03113513|"~     To date no study has determined prospectively which technique is superior to prevent~     recurrent Pelvic Organ Prolapse (POP) after vaginal hysterectomy- a major unmet clinical~     need. The aim of the study is to determine objective anatomical recurrent prolapse after~     Sacrospinous Ligament Fixation (SLF) vs McCall.~   "
34613|NCT03113500|"~     This phase II trial studies the side effects and how well brentuximab vedotin and combination~     chemotherapy work in treating patients with CD30-positive peripheral T-cell lymphoma.~     Monoclonal antibodies, such as brentuximab vedotin may interfere with the ability of cancer~     cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin,~     etoposide, and prednisone work in different ways to stop the growth of cancer cells, either~     by killing the cells, by stopping them from dividing, or by stopping them from spreading.~     Giving brentuximab vedotin and combination chemotherapy may work better in treating patients~     with CD30-positive peripheral T-cell lymphoma.~   "
34614|NCT03113487|"~     This phase II trial studies how well modified vaccinia virus ankara vaccine expressing p53~     (p53MVA) and pembrolizumab work in treating patients with ovarian, primary peritoneal, or~     fallopian tube cancer that has come back. Vaccines made from a gene-modified virus may help~     the body build an effective immune response to kill tumor cells. Monoclonal antibodies, such~     as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving~     p53MVA and pembrolizumab together may work better in treating patients with ovarian, primary~     peritoneal, or fallopian tube cancer.~   "
34615|NCT03113474|"~     Study into the endocannabinoid response to consuming a palatable versus a neutral food.~   "
34616|NCT03113461|"~     The purpose of this project is to determine whether obstructive sleep apnea (OSA) treatment~     with positive airway pressure therapy (CPAP) can delay the progression of cognitive~     impairment in patients with amnestic Mild Cognitive Impairment (MCI) as measured by cognitive~     testing, and brain magnetic resonance imaging (MRI) scans. Study participants will be~     assessed at baseline, six-month (cognitive tests only) and one-year follow-up.~   "
34618|NCT03113435|"~     This study compares the actual standard of care with a new protocol to guide hemodynamic~     optimization during major abdominal surgery, which is more tailored on patient real needs.~     During general anesthesia metabolic needs of the body are markedly reduced and increase in CO~     may not be necessary. In addition, excessive fluid administration has been related to worse~     post-operative outcomes. We divide patients into three groups: the standard treatment group,~     the NICE protocol group and the intervention group. In this group we use the v-aCO2/CaO2-CvO2~     as marker of tissue ability to increase their oxygen consumption in response to increased O2~     delivery, and based on this index the administration of fluid. The principal aim is to~     optimize functional hemodynamics in order to reduce the fluid balance at the end of the~     surgery.~   "
34619|NCT03113422|"~     Patients with high tumor burden, low grade follicular lymphoma that has never been treated,~     will receive venetoclax in combination with obinutuzumab and bendamustine.~      Venetoclax is an oral Bcl-2 family protein inhibitor. It targets the B-cell lymphoma 2~     (BCL-2) protein, which supports cancer cell growth and is overexpressed in many patients with~     follicular lymphoma. Venetoclax may help to slow down the growth of cancer or may cause~     cancer cells to die.~      The purpose of this study is to see whether adding venetoclax to obinutuzumab and~     bendamustine improves the response (the tumor shrinks or disappears) in patients with~     follicular lymphoma.~   "
34620|NCT03113409|"~     The study will enroll 30 opioid-dependent participants into an open-label pilot outpatient~     study of methods to facilitate induction and stabilization onto XR-NTX. There will be three~     different methods of XR-NTX induction using increasing doses of oral naltrexone and~     buprenophine.~   "
34621|NCT03113396|"~     Patients with a clinical suspicion of rumination syndrome and/or supra-gastric belching are~     randomized into baclofen or placebo for 2 weeks (10mg, tid). thereafter, they undergo a high~     resolution impedance manometry measurement, were they receive a solid meal, and recordings~     continue for another hour. Thereafter, they will receive the alternative treatment, after~     which they will undergo a second high resolution impedance manometry measurement. Patients~     are asked to fill out questionnaires during the entire study period.~   "
34622|NCT03113383|"~     The primary objective of the clinical investigation is to assess the use of the thoracic~     bifurcation and the visceral manifold to repair thoracoabdominal aortic aneurysms in patients~     having appropriate anatomy. The primary intent of the study is to assess safety (i.e. freedom~     from major adverse events (MAE) at 30 days) and preliminary effectiveness (i.e., treatment~     success and technical success) of the device (i.e., the proportion of treatment group~     subjects that achieve and maintain treatment success at one year).~      Additionally, the study will assess technical success and treatment success at each follow-up~     interval.~   "
34623|NCT03113370|"~     Almost 12% of women report smoking during pregnancy. Smoking during pregnancy is associated~     with adverse fetal outcomes and up to 35-75% of women quit smoking during their pregnancy.~     Clinical trials of tobacco cessation medications have reported safety concerns along with~     limited efficacy. Subsequently, these medications are not generally recommended in pregnancy~     and most women who stop smoking do so unassisted. Not surprisingly, the rates of smoking~     relapse in the post-partum period are up to 67%. To date, clinical trials of behavior~     interventions in the post-partum period have been largely null. Pharmacotherapy has not been~     studied as a means of preventing relapse in smokers who quit without the use of medications.~     Additionally, these medications are excreted in breast milk, which limits there use for~     lactating women. Thus alternative, safe, and effective strategies to prevent smoking relapse~     in high-risk, former smokers during the post-partum period are needed.~      n-3 long-chain polyunsaturated fatty acids (LCPUFA) have anti-inflammatory properties and~     appear effective as adjuvant therapy for depression. In animal models, n-3 LCPUFA~     deficiencies can result in hypofunctioning of the dopamine mesocorticolimbic pathways which~     are related to reward and dependence. Nicotine results in an elevation of dopamine in the~     nucleus accumbens which is associated with the pleasurable sensations related to nicotine~     use. It has been hypothesized that correcting the hypofunctioning dopaminergic system through~     n-3 LCPUFA supplementation might reduce nicotine cravings. Taken together, these studies~     suggest that supplemental n-3 LCPUFA might be useful in preventing smoking relapse.~      The investigators' hypothesis is that post-partum former smokers randomized to n-3 LCPUFA~     supplementation will be less likely to relapse and have less nicotine cravings compared to~     women allocated to placebo. To test this hypothesis they will conduct a 12-week, randomized,~     double-blind, placebo controlled study of 4 grams/day n-3 LCPUFA supplementation versus~     placebo. Participants will be enrolled prior to hospital discharge. The primary outcomes of~     the trial will be time to smoking relapse and change in self-reported nicotine cravings. The~     secondary outcome will be point prevalence abstinence at 6- and 12-weeks. compliance will be~     monitored by measuring red blood cell phospholipid fatty acid content and verify smoking~     cessation through end-expired CO and cotinine.~   "
34624|NCT03113357|"~     Cervicogenic headache (CeH) is a secondary and often unilateral that is known by referring~     pain from soft or hard cervical structures to occipital, temporal, frontal and sometimes~     pre-orbital regions. There is higher prevalence of cervical muscle tightness, assessed~     clinically in CeH patients and anatomically there are some fascial connections between~     sub-occipital muscles with vertebra of C2 and Dura-mater.Therefore fascial restriction in~     this region can limit the normal movement of muscles between fascial plates in different~     directions in sub-occipital region. The purpose of current study was to compare the effect of~     MFR Technique in the upper cervical region with common (Exs) on pain intensity, frequency,~     duration and Pressure Pain Threshold (PPT) of upper cervical joints in subjects with CeH.~   "
34625|NCT03113344|"~     This study is based on the hypothesis that the pharmacokinetics of anti-infective drugs in~     children are different from adults. We aim to study the population pharmacokinetics of~     children receiving the anti-infective drugs for treatment of infectious diseases. In this~     study, we will detect drug concentration in plasma by using residual blood samples of blood~     gas analysis and other clinical tests and employ computers for constructing population~     pharmacokinetic models. In addition, we also want to correlate use of anti-infective drugs~     with treatment effectiveness and incidence of adverse effects in children. This novel~     knowledge will allow better and more rational approaches to the treatment of infectious~     diseases in children. It will also set the foundation for further studies to improve~     anti-infective drug therapies for children.~   "
34626|NCT03113331|"~     The 3D Cohort Study (Design, Develop, Discover) was established to help bridge knowledge gaps~     about the links between various adverse exposures during pregnancy with birth outcomes and~     later health outcomes in children.~   "
34627|NCT03113318|"~     To study whether or not total mediastinal lymph node dissection in conjunction with pulmonary~     metastasectomy from colorectal cancer is associated with improved survival compared to~     pulmonary metastasectomy only.~   "
34639|NCT03113162|"~     This is a patient-sponsored study that evaluates the safety and efficacy of reduced-intensity~     immunoablation followed by a single dose autologous hematopoetic stem cell transplantation in~     patients diagnosed with multiple sclerosis. Patients are followed-up after 1 month, 3 months,~     6 months and 12 months post-transplantation.~   "
34628|NCT03113305|"~     The Roux-en-Y Gastric Bypass (RYGB) procedure is known to be one of the most successful~     treatments for morbid obesity and Type 2 diabetes mellitus, and has been shown to decrease~     appetite, energy intake, body weight and glycemia both in the short and long term. A number~     of reports hypothesise that these changes may be driven, at least in part, by positive shifts~     in food preferences following surgery. However, findings are drawn from self-reported dietary~     intakes which are beset with measurement bias, thus precluding definite conclusions. The One~     Anastomosis Gastric Bypass (OAGB), or mini-gastric bypass, is another variation on the RYGB~     with one surgical connection (anastomoses) rather than two. Initial data has shown similar,~     or even slightly higher, weight loss and better resolution of diabetes post-surgery than the~     traditional RYGB, however as the technique was first reported in 2001 more long-term data is~     needed.~      The current work aims to directly observe food intake to test the hypothesis that after~     gastric bypass (traditional RYGB and OAGB) food intake changes in a manner which leads to~     beneficial outcomes on body weight when compared to weight stable control participants.~     Patients (n=32; n=16 traditional RYGB, n=16 OAGB) with a planned gastric bypass procedure~     will be recruited from Phoenix Health (Ireland and England) and Letterkenny University~     Hospital (Ireland), alongside control participants (n=16) with no planned weight loss. All~     subjects will attend the Human Intervention Studies Unit (HISU), Ulster University on four~     occasions (1-month pre-surgery and 3, 12 and 24 months post-surgery, with controls being~     time-matched). Study visits will be fully residential involving two overnight stays within~     the facility during which participants' 24-hour food intake will be covertly measured~     (7am-11pm Day 2 and breakfast Day 3) and the following procedures undertaken; basal metabolic~     rate, body composition, bone health, assessment of liking/wanting high fat foods (Visit 1, 2~     & 4 only) and post-meal gut hormone responses. On each study visit participants will have ad~     lib access to a range of foods of varying macronutrient composition and which are compatible~     with their stated food preferences (assessed prior to the start of the study). Changes in all~     ingestive behaviours will be evaluated over time as compared to the control participants and~     between groups ((traditional RYGB vs OAGB).~   "
34629|NCT03113292|"~     The aim will be to compare the effects of a Pilates intervention program with a prescription~     of home exercises in individuals with chronic nonspecific low back pain. A second objective~     will be to assess the cost of interventions, associated with effects on outcomes. This is a~     randomized controlled clinical trial, characterized by the application of therapeutic~     exercises, in two modalities: Pilates Method and Home Prescription of Exercises. Participants~     will be sequentially enrolled and will be randomly allocated into two groups: 1) Pilates:~     which will be submitted to Mat Pilates sessions, 2x / week, for 6 weeks; 2) Home Exercise: 2~     sessions of exercise supervised by a physiotherapist and, after, all participants will~     receive a booklet with the prescription of home therapeutic exercises, to be performed in the~     period of 6 weeks (2x/week) and monitored in a diary. Participants will be evaluated in three~     different moments: 1) Baseline (pre-intervention); 2) At the end of the intervention period~     (6 weeks); And 3) After two months of follow-up. Primary outcomes will be pain (measured by~     VAS), perception of recovery (likert scale of 6-points), functionality (measured by the~     Quebec Questionnaire - QDS) and kinesiophobia (measured by the Tampa Scale of Kinesiophobia).~     Secondary outcomes will be the postural balance and the quality of life. An economic~     evaluation will be carried out, from the economic perspective of the society, with a survey~     of direct and indirect costs, associated to the effects of the interventions. Data analysis~     will be performed through SPSS software version 22.0. The data normality assumptions will be~     evaluated using the Shapiro Wilk test. If the test confirms the assumptions, a mixed ANOVA~     with repeated measures will be used, based on the outcomes (functionality, pain, postural~     balance, quality of life, perception of recovery and kinesiophobia) and independent variables~     (Pilates and Home Exercises), for the comparisons between pre-intervention, post-intervention~     and follow-up. Pilates is expected to have better effects than the home exercise prescription~     group, associated with the outcomes of interest. In addition, the hypothesis is that the~     Pilates costs will exceed the costs from the home-based exercise prescriptions; however, the~     analysis of cost-benefit will demonstrate positive results in favor of the home-exercises.~   "
34630|NCT03113279|"~     Two independent, but interrelated conditions that have a growing impact on healthy life~     expectancy and health care costs in developed nations are the age related loss of muscle mass~     (sarcopenia) and obesity. Sarcopenia affects approximately one third of adults over 60 years~     of age and more than 50% of those over 80 years, which is of concern when one considers that~     the most rapidly expanding population demographic in the UK is adults >80 years of age.~      Skeletal muscle is important in regulating blood glucose and insulin sensitivity. Thus,~     sarcopenia may play a role in exacerbating insulin resistance and progression toward Type II~     diabetes (T2D). Indeed, the highest incidence of T2D in the UK has been noted to occur in~     adults >65 years. Obesity is a major risk factor for chronic diseases including T2D and~     cardiovascular disease. Progression towards obesity is associated with a concomitant decrease~     in muscle mass, producing an unfavorable ratio of fat to muscle. Thus, obesity in old age may~     exacerbate the progression of sarcopenia.~      For the proposed study the investigators will conduct preliminary laboratory tests to~     characterize body composition, insulin sensitivity, systemic inflammation, aerobic capacity~     and muscle protein metabolism (in the fasted and fed state) in healthy older and obese older~     adults for comparison against healthy young individuals.~   "
34631|NCT03113266|"~     This is a multi-center, open-label, phase 2 study evaluating the humanized anti-PD-1 antibody~     JS001, as a monotherapy in patients with locally advanced or metastatic bladder urothelial~     carcinoma who have failed in routine systemic treatment.~   "
34632|NCT03113253|"~     Excision and grafting in burn patients can lead to severe blood loss. A preliminary study~     conducted in our burn unit showed that the total median blood loss was 1412 mL (1).~     Transfused patients had a total median blood loss of 2468 mL and an average number of 4~     packed red blood cells (PRBC) administered.~      Among the various methods that help limit blood loss, tranexamic acid, which has been proved~     useful in traumatology and surgery, has not been sufficiently studied in burn patients. A~     preliminary study in 27 burned patients showed a reduction of blood loss with tranexamic acid~     (2).~      Objective of TRANBURN study is to demonstrate that tranexamic acid help limit blood loss and~     reduces the use of blood products.~   "
34633|NCT03113240|"~     Glutamine-induced recovery in intestinal barrier function by reducing bacterial translocation~     was demonstrated in previous studies. In this trial, intensive care unit patients with~     enteral feeding will receive either enteral glutamine or maltodextrin as placebo for 10 days~     and the effects of the intervention on intestinal permeability will be assessed.~   "
34634|NCT03113227|"~     Seventy ladies indicated for induction of delivery will be recruited. Two ways of assessment~     of their cervices will be done before actual induction of labor. First, ultrasound will be~     done to assess the angle and the length of the cervix. Then vaginal examination will be done~     to assess the characteristics of cervix. Analysis will be done to identify the best predictor~     of successful induction of labour.~   "
34635|NCT03113214|"~     The goal of this study is to find the maximum tolerable dose of radiation that can be~     delivered with concurrent chemotherapy (carboplatin & paclitaxel) in patients with esophageal~     cancer.~   "
34636|NCT03113201|"~     The aim of the study Collabri Flex is to:~        -  Develop a Danish model for collaborative care for patients with depression in general~          practice, based on past experience gained in the Collabri Project.~        -  Examine the impact of this model compared with liaison-consultation for people with~          depression in a randomized controlled design from selected endpoints.~   "
34637|NCT03113188|"~     This is a multicenter, open-label, phase 1b study of CBP501/cisplatin/nivolumab combination~     administered once every 21 days to patients with advanced solid tumors.~   "
34640|NCT03113149|"~     Individuals with painful knee osteoarthritis (OA) experience restricted physical function.~     Few previous studies have investigated comprehensive sets of constructs and tests to~     investigate physical function in these patients. Most single studies of knee OA patients show~     limited scope for explaining physical function in the perspective of WHO's International~     Classification of Functioning, Disability and Health (ICF) 3 levels: Body functions (the~     bodily level), Activities (individual level), and Participation (societal level). On the~     bodily level there is limited case-control knowledge on muscle strength beyond the knee and~     endurance-strength in general. On the activity level, there is similar limitation of~     biomechanical bodily features in stair climbing. On the participation level the situation is~     similar for objective performance. Measures are needed that inter-relate all three levels of~     ICF. These should also include well discriminating tests e.g. knee strength, walking, and~     activities of daily life (ADL), as well as both objective and subjective measures.~      The purpose of this study is to explore mechanisms that can explain physical function in~     patients with knee OA in primary care. The study's main and primary goal is to quantify which~     baseline factors and change scores are the strongest predictors of a positive treatment~     outcome in terms of patients' global perceived change after physiotherapy. Secondary research~     question is: which factors are the strongest predictors of a positive outcome of~     physiotherapy in knee OA, in terms of pain intensity, patient specific functional scale, and~     function in daily living?~   "
34641|NCT03113136|"~     The overall aim of the proposed study is to evaluate the effect of switching from~     conventional cigarettes to either a LWe or HWe on smoking behavior, product use patterns and~     continued use, as well as biomarkers of toxicant exposure and effects.~   "
34642|NCT03113123|"~     Interventional HIV prevention strategy based on pre-exposure prophylaxis (PrEP) with Truvada®~     for people in the Île-de-France area (or Paris region) who don't have HIV but who are at high~     risk of becoming infected with HIV (men who have sex with men (MSM), transgender men and~     women, heterosexual men and women, sex workers, migrants) in combination with overall~     prevention services (communautary-based or educational counselling; addiction, social and~     psychological care; condoms and lubricating gel; clean injection equipment; sexually~     transmitted diseases (STD) screening and treatment; hepatitis A virus (HAV), hepatitis B~     virus (HBV) and hepatitis C virus (HCV) vaccinations and post-exposure treatment of HIV~     infection as soon as possible after diagnosis using an antiretroviral combination recommended~     by the French Guidelines on HIV treatment).~      The individual benefit being already demonstrated in clinical trials, the aim is to~     demonstrate the public health impact of the interventional HIV prevention strategy by~     reducing the risk of getting HIV-1 infection of at least 15% of new diagnosis of HIV~     infections among MSM/transgender in the Ile-de-France area after a 3-year period.~   "
34643|NCT03113110|"~     RELEVANCE:~      Up to 50% of patients without previously known disorders of glucose metabolism develop~     posttransplantation diabetes mellitus (PTDM) after renal transplantation, which is associated~     with cardiovascular events. Although PTDM is triggered by immunosuppressive agents~     (calcineurin inhibitors, glucocorticoids), there is consensus against switching patients from~     potent tacrolimus to the less diabetogenic cyclosporin. Full-blown PTDM must therefore be~     treated aggressively. Empagliflozin inhibits sodium-glucose cotransporter 2 in the proximal~     tubule of the kidney and dramatically reduced cardiovascular risk in type 2 diabetics in a~     recent randomized trial. Especially in diabetics with impaired renal function, empagliflozin~     was safe, well tolerated, and effective against hyperglycemia and against high blood~     pressure. Data on SGLT2 inhibition after transplantation are completely lacking. Therefore,~     the potential antidiabetic of choice is currently withheld from the vulnerable PTDM~     population.~      METHODS, STUDY DESIGN:~      Prospective, single-center, non-inferiority study. Inclusion criteria: PTDM (antidiabetic~     therapy ≥6 months, based on prior 2-h BG ≥200 mg/dL, fasting BG ≥125 mg/dL (2 times) or HbA1c~     ≥6.5%); stable renal allograft function >6 months; eGFR ≥30 mL/min/1.73m2. Most important~     exclusion criteria: type 1 and 2 diabetes; insulin demand >40 IU/day; HbA1c >8.5%. After~     study inclusion, patients will record 4 weeks of 4-times daily BG measurements before~     undergoing an OGTT, lab work and urine analysis (including ketones, urinary culture).~     Empagliflozin (10 mg) will be started and insulin discontinued within 3 days. Patients will~     be asked to perform urinary dipstick tests at home (i.e. ketones), and to continue recording~     BG. Study visits at 2 and 4 weeks (second OGTT + lab work (as above)). If control over~     hyperglycemia is insufficient, insulin therapy will be added back, otherwise study patients~     remain on empagliflozin monotherapy for 1 year. Statistics will include the paired t-test.~   "
34644|NCT03113097|"~     Women planned to undergo blastocyst-stage embryo transfer after IVF/ICSI were randomized into~     2 groups:~        -  group I: women who had only good-quality embryo transfer.~        -  group II: women who had both good-quality and poor-quality embryo transfer.~      primary outcome was ongoing clinical pregnancy rate~   "
34645|NCT03113084|"~     The purpose of this phase I study is to know the pharmacodynamic profile in humans of the~     sodium heparin of porcine origin of the company União Química, building from the~     pharmacodynamic data generated its pharmacokinetic profile, due to the dosage limitation of~     heparin directly in biological samples. In addition, the toxicity of the product will be~     evaluated in healthy male participants.~   "
34646|NCT03113071|"~     The primary hypothesis is that digoxin can be safely added to decitabine and will increase~     the response rates in medically unfit patients with newly diagnosed AML/MDS or those with~     relapsed/refractory AML/MDS. Furthermore, it is hypothesized that the addition of digoxin to~     decitabine will result in distinct epigenetic alterations in AML/MDS patients.~   "
34647|NCT03113058|"~     To evaluate the safety and anti-HBV efficacy of γδT cells.~   "
34648|NCT03113045|"~     The study will determine the 90% effective seated time after intrathecal injection of~     hyperbaric bupivacaine to avoid hypotension in patients undergoing cesarean delivery.~   "
34659|NCT03112902|"~     Loss of slow wave sleep (SWS) is common in mild cognitive impairment (MCI) and Alzheimer's~     disease, and is thought to worsen thinking, memory and brain degeneration. Initial studies~     suggest that correction of sleep deterioration may slow the progression of brain damage in~     mild cognitive impairment, and might be able to stop the development of Alzheimer's disease.~     Transcranial alternating current stimulation (tACS) uses electrodes to deliver very small~     amounts of electricity through the brain, with direct effects on brain cell function.~     Transcranial electric stimulation has been demonstrated to enhance slow wave sleep and to~     improve memory when applied during sleep in healthy adults. The purpose of this research is~     to investigate tACS to modulate sleep, thinking/memory, mood, and quality of life among~     normal healthy adults, older adults, as well as individuals with MCI.~   "
37213|NCT03079531|"~     This is a study to determine whether secukinumab is a potential therapy for those with~     papulopustular rosacea. We will observe whether this drug decreases the size and/or amount~     and severity of the pustules of those who suffer from rosacea.~   "
34649|NCT03113032|"~     Total knee replacement (TKR) is the treatment of choice for patients suffering from long~     standing severe pain, functional limitation and instability caused by osteoarthritis (OA) of~     the knee joint's surfaces. Long standing arthritic joint surfaces, more often lead to pain~     and swelling and other physical factors that may contribute to knee joint instability. This~     instability causes a feeling of 'unsteadiness' whilst walking and may also contribute to~     falls. In view of the latter, it is important for this issue of 'unsteadiness' to be~     addressed. TKR helps to remove the cause of pain and swelling, but exercises are crucial to~     counteract the joint' instability and any feeling of 'unsteadiness' before and after surgery.~     However, research hasn't yet identified the optimum approach for delivering exercises that~     will help in patients' rehabilitation. Current studies have tried to incorporate~     rehabilitation programmes to improve this issue, but required a delivery of 6-8 weeks of~     exercises which has resulted in a logistical burden in view of the long duration. We have~     scientifically developed a new programme of exercise for the muscles of the knee that can be~     delivered during a single week prior to surgery. The pre-surgery exercise-programme (P-SEC),~     potentially offers similar effectiveness for improving the feeling of 'unsteadiness' and~     muscle' fitness as programmes that last much longer. Therefore, the purpose of this research~     study is to test the effectiveness of this new, short approach to exercising in patients who~     are waiting for a TKR surgery.~   "
34650|NCT03113019|"~     The purpose of this work: to assess the tolerability and effectiveness of the autogemotherapy~     method on the basis of autologous antigen-activated dendritic cells in the treatment of~     patients with breast cancer.~      This technology is intended for complex treatment of patients with breast cancer and is aimed~     at preventing the occurrence and treatment of secondary foci. The need for this technology is~     justified by the widespread occurrence of breast cancer among women, a decrease in the~     average age at onset of the disease and a young age, and the chemoresistantness of locally~     advanced forms of cancer.~   "
34651|NCT03113006|"~     Background Diabetic eye disease is the most frequent complication among the 320,000 Danes~     with diabetes. The formation of new vessels (PDR) in the inner part of the eye (retina) is a~     feared complication and a leading cause of blindness, since these vessels are fragile and~     often cause bleeding within the eye. Peripheral retinal laser treatment (PRP) halves the risk~     of blindness, but often comes with a high prize. The peripheral part of the retina is~     responsible for the visual field and the night vision, and PRP limits these abilities (i.e.~     loss of driving license).~      The technique of PRP has principally been the same for the past 40 years with standard~     treatment given for all patients. With this one size fits all approach, a substantial number~     of patients will either be treated too much or too little. Too little treatment is~     inefficient, and disease progression may occur. Excessive treatment may cause side effects~     like loss of visual fields and decreased night vision. Therefore, it is important to test if~     treatment can be applied on an individual basis to give high efficacy treatment with minimal~     side effects.~      IMPETUS 2018 - TREAT is the second of two studies aimed at making an individual design for~     retinal laser treatment. In IMPETUS 2018 - DETECT the investigators demonstrated that~     non-invasive examinations of the oxygen level and measurements of the retinal vascular tree~     provide important information of individual treatment response. For instance, if standard PRP~     led to three per cent higher retinal oxygen saturation, there was a 4-fold risk of disease~     progression despite treatment. Hence, such a patient would benefit from more treatment to~     avoid blindness. With these observations at hand, the investigators want to compare a less~     invasive treatment (individualized laser treatment) against the standard PRP.~      Another essential aspect in the treatment of PDR is to be able to give the right diagnosis~     and to evaluate the efficacy of laser treatment. So far, this has been performed by~     fluorescein angiography. However, this examination are highly person-dependent and unpleasant~     to patients, and a more objective approach is needed. Optical coherent tomography angiography~     (OCT-A) is a quick, noninvasive scanning of the retina which is ideal to visualize moving~     objects like blood within the retinal vessels. The method has been successfully implemented~     in a number of retinal diseases, but it has never been validated in PDR.~      Standard PRP is often performed in 3-4 sessions. However, it may be painful, and patients~     sometimes choose not to complete all sessions after the initial treatment has been given.~     There is insufficient knowledge of the patient-barriers to treatment, and it is important to~     address these in an individualized treatment design.~      Aim In this 6-month 1:1 randomized, prospective study the investigators want to investigate~     1) whether individualized retinal laser treatment compared with standard PRP has the same~     efficacy but less side effects, 2) whether OCT-A can be used as an objective marker for~     disease activity, and 3) to obtain a better understanding of patient-reported barriers to~     standard laser treatment PRP and whether these can be addressed with personalized retinal~     laser treatment.~      Setup Fifty eight consecutively recruited patients (1 May 2017 - 30 April 2018) with newly~     diagnosed PDR referred to the Department of Ophthalmology, OUH, and randomly assigned to~     standard PRP (n=29) or individualized laser treatment (n=29).~      Intervention Standard laser treatment is performed in all four quadrants of the retina.~     Individualized laser treatment is only performed in the part(s) of the retina with~     proliferation(s).~      Both treatments are carried out at baseline (BL), and additional treatment is given at month~     three (M3) and/or (M6), if necessary.~      Investigations Retinal digital images, fluorescein angiography, OCT-A (BL, M3, M6). Test of~     visual fields, dark adaptation and quality of life (BL, M6). Semi-structured interview will~     be performed with five patients who have received PRP in one eye and individualized laser~     treatment in the other eye. This will address treatment experience, potential barriers to~     treatment, etc.~      What to measure:~      Differences in need for retreatment, night blindness, visual fields, visual acuity, bleeding~     in the eye, surgery, and quality of life between the groups.~   "
34652|NCT03112993|"~     Spine surgery is one of the most common operative procedures in the United States. It is~     performed in the prone position (a patient laying on belly). Muscle relaxants are given for~     neuromuscular blockade often referred as paralysis for surgical exposure which is maintained~     until the patient is returned to the supine position (a patient laying on back) at the end of~     surgery. At the end of the surgery the paralysis is reversed with a drug (neostigmine). A new~     drug (sugammadex) has the ability to rapidly reverse the paralysis but it is not well~     investigated in elderly. This study will investigate speed of recovery and complications of~     the two reversal drugs in elderly patients (age ≥ 65 years) undergoing posterior spine~     surgery.~   "
34653|NCT03112980|"~     Randomized controlled, multi-center trial randomizing patients with symptomatic severe aortic~     stenosis at low to intermediate operative risk of mortality, as assessed by the~     STS-PROM-Score, in a 1:1 fashion to transcatheter aortic valve implantation (TAVI) or~     surgical aortic valve replacement (SAVR) to test, whether TAVI is non-inferior to SAVR~     regarding short and long-term mortality (1 and 5 year).~   "
34654|NCT03112967|"~     The investigators will investigate the safety and efficacy of low-volume preparation (Oral~     Sulfate solution) compared to 4L PEG solution in bowel preparation before colonoscopy.~      One aim of this study was to investigate the efficacy of low-volume preparation (Oral Sulfate~     solution) on bowel preparation before colonoscopy.~   "
34655|NCT03112954|"~     Introduction: Bruxism is a parafunctional habit that affects the stomatognathic system and~     its support structures. Usually associated with stress and mostly occurring at night, bruxism~     leads to sleep disorders and daily tension headaches. Aiming to rebalance the emotional and~     physical state of patients, floral-essence therapy lacks side effects or drug interactions,~     and has been recognized by the World Health Organization. Aim and Methods: The investigators~     created a buccal-relaxant formula, combining 8 floral essences and testing it in a~     double-blind clinical assay conducted in bruxism patients. Results: An alcohol solution of~     the buccal relaxant containing Daughter of Gaia floral essences of Taraxacum officinale,~     Antirrhinum majus, Fuchsia × hybrida, Bidens bipinnata, Campanula carpatica, Achyrocline,~     Nymphaea caerulea, and Tetraoensis riparia significantly attenuated temporal headaches in the~     bruxism patients compared to the placebo group (69.46%±1.79 versus 3.55%±1.37, P=0.0001).~     Moreover, patients after 21 days using the buccal relaxant increased their quality of sleep~     and experienced attenuated jaw-muscle rigidity or morning mouth-opening difficulties. Less~     masseter hypertrophy and reduced sensitivity due to abfraction of enamel facets were noted as~     well. Conclusions: The buccal-relaxant formula may have sedative properties, preventing daily~     temporal headaches in sleep-bruxism patients, suggesting a muscle-relaxation effect. Although~     the results are promising, long-term studies are needed to clarify the pharmacological~     mechanism of each floral essence in the buccal-relaxant formula and their tolerance effects.~   "
34656|NCT03112941|"~     To observe modified Barthel index, American Spinal Injury Association (ASIA) impairment scale~     grading, sensory score and motor score in patients with incomplete SCI in the plateau using~     0.2 MPa HBO combined with pedicle screw fixation and decompressive laminectomy so as to~     investigate the effect of HBO therapy on incomplete SCI in the plateau.~   "
34657|NCT03112928|"~     This international, multi-center, double-blind, randomized, controlled clinical trial aims to~     evaluate the efficacy of Phantom Motor Execution (PME) and Phantom Motor Imagery (PMI) as~     treatments of Phantom Limb Pain (PLP). In PME, myoelectric pattern recognition (MPR) is used~     to predict motor volition and then use the decoded movements to control virtual and augmented~     reality environments (VR/AR), along with serious gaming (SG). The same device and VR/AR~     environments are used in PMI with the difference that subjects will imagine rather than~     execute phantom movements. Electromyography is used to monitor for no muscular activity in~     PMI.~   "
34658|NCT03112915|"~     In this study, investigators aimed to compare the Quadratus Lumborum Block and the~     Transversus Abdominis Plan Block for postoperative pain control after laparoscopic~     cholecystectomy~   "
34670|NCT03112759|"~     This study will assess cognitive behavioral therapy as an adjunct to conventional symptom~     control for patients with chronic pancreatitis.~   "
35271|NCT03104907|"~     The aim of this study is to investigate the safety and efficacy of prostatic artery~     embolization of patients with recurrent symptoms secondary to locally advanced prostatic~     cancer including pelvic pain, bleeding or need for permanent urinary catheter who are unfit~     for or refuse surgical treatment.~   "
34660|NCT03112889|"~     McArdle disease is a metabolic myopathy characterised by the absence of glycogen~     phosphorylase in skeletal muscle. Sodium Valproate is part of a group of drugs known as~     histone deacetylase inhibitors, which have a direct effect on chromatin. Recently a drug~     trial in an animal model of McArdle disease showed that sodium valproate stimulated the~     expression of a different isoform of the missing enzyme in skeletal muscle.~      A safety and feasibility study of sodium valproate in people with McArdle disease has been~     carried out in London (UK) and Copenhagen (DK) since January 2015. Participants will receive~     20mg/Kg/day of sodium valproate for 6 months. The primary outcome measure is exercise~     performance assessed by cycle ergometry. Pre and post-treatment skeletal muscle biopsies will~     be performed to assess for glycogen phosphorylase. Together with blood analyses for safety.~     Additional functional exercise tests will be performed.~   "
34661|NCT03112876|"~     The goal is this study is to evaluate how the skin surface lipid composition is correlated~     with overall sebum production, barrier function, and inflammatory disease status. We~     hypothesize that there will be differences in the skin surface composition among subjects of~     various groups:~        1. Young vs older healthy population~        2. Atopic dermatitis vs Acne vs Healthy controls~        3. Active smokers vs non-smoker controls~   "
34662|NCT03112863|"~     Subjects will be assigned to a retinoid cream or bakuchiol to compare the cosmetic effects.~     This will take place over a 12 week period.~   "
34663|NCT03112850|"~     Sensorineural type of hearing loss is the most common sensory deficit among older adults.~     Some of the psychosocial consequences of this condition include difficulty in understanding~     speech, depression and social isolation. Studies have shown that older adults with hearing~     loss show some age-related cognitive decline. There is no clinically proven method to predict~     the onset of this condition, as its occurrence is slow and progressive, affecting both ears~     equally. Although hearing aid use and auditory training have been proven as successful~     interventions to alleviate sensorineural hearing loss, no research has been designed to look~     at the effect of both hearing aid use coupled with auditory training on cognitive performance~     in older adults. This study will investigate whether wearing hearing aids will improve the~     impact of auditory training on cognition, mood and social interaction for older adults with~     sensorineural hearing loss.~      This is a crossover trial targeting older adults between 50 and 90 years with either mild or~     moderate symmetric sensorineural hearing loss. Consented, willing participants will undergo a~     six month intensive auditory training program (active control), as a rigorous means of~     examining the impact hearing aid use has on a person's cognition, mood and social~     interaction. Participants will be assigned in random order to receive hearing aid~     (intervention) for either the first three or last three months of the six month auditory~     training program. Each participant will be tested at baseline, three and six months on a~     battery of computer based cognitive assessments, together with mood, and social engagement~     measures. Effectiveness of hearing aids and auditory training will be evaluated using an~     online speech perception test (SPT) and the Abbreviated Profile of Hearing Aid Benefit~     (APHAB) Inventory.~      This study will investigate whether using a hearing aid coupled with auditory training can~     improve a person's cognition and learning abilities, relationships with family and friends,~     and quality of life. Results from the study will inform strategies for aural rehabilitation,~     hearing aid delivery and future hearing loss intervention trials.~   "
34664|NCT03112837|"~     Effect of Live Combined Bifidobacterium,Lactobacillus and Enterococcus Capsules on Oral~     Mucositis in Nasopharyngeal Carcinoma Patients Receiving Radiotherapy.~   "
34665|NCT03112824|"~     Patients who are involved in a clinical protocol driven 12 week medical weight loss~     intervention will be randomized to receive either a placebo or 600 mg of an ashwagandha root~     extract. The study endpoints are primarily the patients self-reported perception of life~     stress and sleep quality. The working hypothesis of this study is that the addition of~     aschwagandha to .the medical weight loss program will improve the self-reported perception of~     life stress and sleep quality~   "
34666|NCT03112811|"~     The purpose of this study is to compare the effect of the autogenic drainage and the~     intrapulmonary percussive ventilation on the levying of the lung atelectasis, by means of the~     thoracic imaging (thoracic ultrasound and radiography), at the intubated or extubated child~     with the ventilatory support.~   "
34667|NCT03112798|"~     Miller blades are commonly used in pediatric anesthesia; however, there is less~     evidence-based information on the superiority of Miller blades in the visualization of the~     laryngeal inlet to Macintosh blades. The aim of the present study is to compare the glottic~     views with the size 0 Macintosh and Miller laryngoscope blades above and below the~     epiglottis.~   "
34668|NCT03112785|"~     Main question: Will use of a stem design that allows anatomical reconstruction of the hip~     joint improve the outcome in terms of hip function and patient satisfaction without causing~     any adverse effects?~      Background: Total hip arthroplasty with use of the most well documented implants is a safe~     and cost-effective procedure. In the Swedish Hip Arthroplasty register the CLS stem has a 16~     years implant survival of 97, 5 %. It is a classic design which requires resection of most of~     the neck. The stem also intrudes into the greater trochanter which in patients with certain~     types of proximal hip anatomy makes proper introduction of the stem difficult. Finally it has~     a standard stem length which will jeopardise future stem removal should there occur any late~     infection or instability problems.~      Short uncemented stems have been introduced to enable a more anatomic reconstruction of the~     hip joint and to cause less invasion of the femoral canal to facilitate future revision~     should it be necessary. A more conservative resection of neck could also be of value to~     improve the clinical outcome by improved hip function and patient satisfaction.~      Purpose of the present study and design: In a prospective study the clinical outcome, stem~     fixation and bone remodelling around a short stem (Fitmore) will be studied. The main focus~     will be to evaluate patient reported outcomes especially concerning function, over all~     satisfaction, pain and activity. All patients will receive the same cup (Trilogy). This cup~     is chosen because it has a very thorough documentation in prospective RSA studies and in the~     Swedish hip arthroplasty register. All cups will be supplied with insert made of high~     molecular polyethylene (Longevity).~      Number of hips in the study: 44 consecutive cases~   "
34669|NCT03112772|"~     Changes in alveolar bone following teeth extraction can compromise implant placement. Socket~     preservation (alveolar ridge preservation) is considered as a surgical procedure employed to~     preserve the ridge volume within the envelope existing at the time of extraction.The ultimate~     aim of such procedure is to compensate the expected amount of horizontal and vertical~     alveolar bone resorption. In order to better understand which socket preservation materials~     might be more effective for ridge preservation and to strengthen the evidence that is~     relevant to the clinicians' choice of socket preservation materials, two different materials~     were compared in a randomized controlled approach. (1) Demineralized Bone Matrix (DBM) Putty~     and Putty with Chips allograft covered by collagen membrane, and (2) Deprotonated bovine bone~     xenograft covered by collagen membrane. The independent variable is the grafting material~     while the dependent variables are the change in socket height, and width; the ability of~     implant placement without the need for grafting and the success rate of implants at the time~     of loading.~   "
34671|NCT03112746|"~     Children with Developmental Coordination Disorder (DCD) have difficulties performing daily~     activities which reflects negatively on participation, impacting their lives. To date, there~     are a number of interventions to improve performance of these children on activities they~     want or need to. In Brazil, there is little research on the efficacy of such approaches. Our~     main objective was to start a set of studies to examine the effects of the Cognitive~     Orientation to Daily Occupational Performance Approach (CO-OP Approach) protocol on~     occupational performance and satisfaction of Brazilian children who have DCD; to examine~     whether children were able to transfer strategies and skills learned during CO-OP to~     untrained goals.~   "
34672|NCT03112733|"~     This study evaluates the usefulness of serum levels of trefoil factor 3 (TFF3), secreted~     frizzled related protein 4 (sFRP-4), reactive oxygen species modulator 1 (Romo1) and nuclear~     factor (NF)-κB as potential diagnostic and prognostic biomarkers in ovarian carcinoma.~   "
34673|NCT03112720|"~     The purpose of this study is to compare a pain block in the midface, versus the traditional,~     more invasive, therapeutic epidural patch for the treatment of headaches~   "
34674|NCT03112707|"~     Objective: To evaluate the safety of bioresorbable polymer-coated everolimus-eluting Synergy®~     stent followed by 1-month dual antiplatelet therapy in patients at high-bleeding risk.~      Study population: Real world high-bleeding risk (HBR) patients with coronary artery disease~     (stable as well as acute coronary syndromes) who qualify for percutaneous coronary~     interventions.~      Study size: A total of 1023 patients will be enrolled. Study design: Prospective, single-arm,~     multicentre trial, powered for non-inferiority with respect to objective performance criteria~     (OPC).~      Antiplatelet therapy: Dual antiplatelet therapy with aspirin 100 mg od and a P2Y12 inhibitor~     for a duration of 1 month, after which single antiplatelet therapy with aspirin will be~     recommended indefinitely. In case of need for oral anticoagulation, patients will receive an~     oral anticoagulant in addition to a P2Y12 inhibitor without aspirin for 30 days.~      Primary endpoint: Composite of cardiac death, myocardial infarction, or definite/probable~     stent thrombosis at 1-year follow-up.~   "
34675|NCT03112694|"~     The purpose of this study is to understand how people with neuroendocrine tumors respond to~     treatment with lanreotide after having received treatment with octreotide.~   "
34676|NCT03112681|"~     Study SARO.16.004.02 is a prospective, multicenter, randomized, double-blind,~     placebo-controlled study to evaluate safety, tolerability and efficacy of saroglitazar~     magnesium 2 mg, 4 mg in Patients with Primary Biliary Cholangitis. A total 36 subjects will~     be enrolled in a ratio of 1:1:1 to receive either saroglitazar magnesium 2 mg or saroglitazar~     magnesium 4 mg or placebo. The primary objective is to investigate the effect of a 16-week~     treatment regimen of Saroglitazar magnesium 2 mg and 4 mg on ALP levels in patients with~     Primary Biliary Cholangitis.~   "
34677|NCT03112668|"~     This pilot clinical trial studies how well acceptance and commitment therapy works in~     improving well-being in patients with stage III-IV cancer and their partners. Learning how to~     accept negative thoughts and feelings and how to live in the present without worrying about~     the future or past may improve coping skills in patients with stage III-IV cancer and their~     partners.~   "
34678|NCT03112655|"~     The study validates the diagnostic performance of cerebrospinal fluid neopterin~     quantification and of blood and cerebrospinal fluid trypanosomal spliced leader RNA detection~     for assessing outcome after treatment of human African trypanosomiasis.~   "
34679|NCT03112642|"~     To help determine if there is improved pain relief when a device that makes an arm muscle~     move (nerve stimulator) is used to place a needle in the area above the collarbone to prevent~     feeling of pain (anesthesia) of the upper arm.~   "
34680|NCT03112629|"~     Multi-centre, multi-national, observational, prospective registry in four central full access~     centres in Germany (2), France (1) and the United Kingdom (1) and up to two satellites per~     hub (smaller hospitals / office based cardiologists (OBC) without access to surgical and~     percutaneous aortic valve (AV) interventions).~      The hypothesis is that the management of patients with severe AS will differ between sites~     with on-site access to all treatment modes and those without such facilities.~   "
34681|NCT03112616|"~     One of the causes of disability in patients suffering from a stroke is postural imbalance.~     Sensory stimulation improves the postural symmetry of the subject transitorily and they are~     thought to have an effect on the spatial frame of reference through a sensory recalibration.~     Studies have shown that sensory stimulation by vibration of neck muscles have an immediate~     effect on static balance and when walking. The objective of this preliminary study is to test~     the long-lasting effects of repetitive neck muscle vibrations on postural disturbances in~     standing position and on spatial frame reference in chronic patients.~   "
34682|NCT03112603|"~     The purpose of this study is to assess the efficacy of ruxolitinib against best available~     therapy in participants with steroid-refractory chronic graft-versus-host disease (SR cGvHD).~   "
34683|NCT03112590|"~     This purpose of this study is to evaluate the safety and to find the optimal dose in~     participants with human epidermal growth factor receptor 2 (HER2) positive breast cancer who~     are given the combination of Interferon-gamma with paclitaxel, trastuzumab and pertuzumab.~     This study will also look at other effects of Interferon-gamma with paclitaxel, trastuzumab~     and pertuzumab, including its effect on this type of cancer.~      Interferon-gamma is a biologically manufactured protein that is similar to a protein the body~     makes naturally. In the body, interferon gamma is produced by immune cells and helps to~     prevent serious infections.~   "
34684|NCT03112577|"~     To assess the effects of REGN3500, dupilumab, and REGN3500 plus dupilumab, compared with~     placebo, on changes in inflammatory gene expression signatures in sputum induced after a~     bronchial allergen challenge (BAC) in adults with mild allergic asthma, at week 4 after~     treatment initiation compared with those at screening.~   "
34685|NCT03112564|"~     Prospective study conducted between March 2013 and November 2014 at Hospital Universitario~     Puerta de Hierro-Majadahonda, in Madrid, Spain to identify complications and evaluate the~     efficacy of pure inhalational anesthesia induction to achieve endotracheal intubation without~     the use of muscle relaxant and analgesic drugs.~   "
34686|NCT03112551|"~     the investigators assume that magnesium sulphate for treating eclampsia can be safely reduced~     from 24 hours to shorter duration of therapeutic anticonvulsant effect for 12 hours. Short~     duration of drug exposure is suitable for low resource setting where there is little tools or~     busy staff for monitoring drug toxicity.~   "
34687|NCT03112538|"~     The purpose of this study is to evaluate the comparative efficacy of insulin pump therapy~     versus multiple daily injections in insulin-taking type 2 diabetes mellitus who are~     sub-optimally controlled with premixed insulin regimen. This research is necessary because~     many patients with type 2 diabetes mellitus do not meet their glucose targets.~      In advanced Type 2 diabetes mellitus, many patients develop worsening diabetes control and~     unable to reach the glucose targets despite intensive insulin regimens.This is further~     complicated by the risks of low blood sugar and weight gain. These limitations of multiple~     daily injection treatment show the need for new treatments for this group of patients.~   "
34688|NCT03112525|"~     New/direct oral anticoagulants (NOAC/DOAC), like apixaban and rivaroxaban, are an interesting~     alternative to unfractionated or low molecular weight heparin relayed by oral anti-vitamin K~     anticoagulants (VKA) for the treatment of venous thromboembolism and atrial fibrillation.~     This new generation of anticoagulants directly inhibit a factor in the blood coagulation~     pathway and have a wide therapeutic range overcoming several practical issues associated with~     VKA therapy including the need of routine coagulation monitoring potentially simplifying~     patient management. However, despite this wide therapeutic range, a large interindividual~     dose variability related to factors such as age, body surface, smoking, concomitant diseases~     as well as differences in drug metabolism, could put susceptible patients at risk for~     uncontrolled bleeding. Both rivaroxaban and apixaban are cleared primarily via cytochrome~     P450 (CYP) mediated hepatic metabolism, mainly CYP3A, and renal excretion, involving the~     P-glycoprotein (P-gp). Both CYP3A and P-gp activity show important interindividual variations~     due to drug interactions and/or genetic polymorphisms in corresponding genes.~      The aim of the current study is to evaluate the impact of cytochrome activity and relevant~     polymorphisms on rivaroxaban/apixaban dosage regimen or treatment efficacy in a hospital~     setting. The safety issue in this context is particularly relevant, since hospitalisation is~     linked to a modification of the patient's treatment with often an increase in the number of~     medications. The resulting changes in metabolism due to modified cytochrome and transporter~     activities could affect rivaroxaban/apixaban blood concentrations. Our central hypothesis is~     that genotype and/or phenotype in CYP3A4/5/7 or P-gp may influence the rivaroxaban/apixaban~     plasma concentration and increase the risk of thrombotic or hemorrhagic events. Thus,~     investigating how the patient's genotype and/or phenotype for CYP3A4/5/7 and P-gp could~     potentially alter the bio-disponibility of rivaroxaban and apixaban and therefore the risk to~     develop adverse events or inefficacy would be of particular interest.~   "
34689|NCT03112512|"~     To Select the Optimal Positive End-expiratory Pressure in Moderate and Severe Acute~     Respiratory Distress Syndrome Patients by Using:~        1. the novel Non-invasive Electrical Impedance Tomography Guided Method~        2. the Protective ventilation tool G5(MV)~   "
34690|NCT03112499|"~     The main aim of the study is to investigate and compare the possible acute effect of standard~     PCNL, mini-PCNL and RIRS on renal function. Secondary aims are to investigate the efficacy~     (stone-free rate), safety (complication rate, long-term kidney function) and other parameters~     (operation, fluoroscopy and hospitalization time) concerning the 3 endourological operations~     (PCNL, mini- PCNL, RIRS) for the treatment of renal calculi.~   "
34691|NCT03112486|"~     Few early prognostic indicators are currently available for patients' families and clinicians~     following out of hospital cardiac arrest (OHCA), and blood biomarkers may be of prognostic~     value in these cases. Brain tissue is highly dependent upon aerobic respiration, and oxygen~     deprivation result in irreversible neuronal cell injury. Peptides released into the blood by~     injured neuronal cells can be measured to estimate degree of injury, and potentially predict~     long term neurological outcome.~   "
34692|NCT03112473|"~     This proposed study aims to compare the effects of unilateral and bilateral transcutaneous~     electrical nerve stimulation (TENS). It will compare the effectiveness of bilateral TENS +~     task-oriented training (TOT) with unilateral TENS+TOTin improving upper limb function in~     patients with chronic stroke.~      The null hypothesis will be that bilateral TENS+TOT and unilateral TENS+TOT are not~     significantly different in promoting the recovery of upper limb functions.~   "
34693|NCT03112460|"~     In a prospective, non-randomized study, all of the basic and advanced cardiopulmonary~     resuscitations would be analyzed. All resuscitation are planned to be performed by the above~     mentioned devices according to the recent protocols. The continuous audio-visual feedback and~     all the data obtained during the resuscitation are intended to develop a better CPR training~     program in the future.~      The downloading of data is planned to occur on the same day of CPR to a data card. After~     approximately one week all the participant medical persons would receive a detailed case~     analysis. Elimination of the typical errors is targeted.~      Monitored quality indicators~      Follow-up of CPR protocol:~      elapsed time between turning on device and first chest compression elapsed time between~     turning on device and first delivered shock elapsed time between turning on device and first~     delivered shock in case of shockable rhythm compliance with 2 minutes long CPR period~     recognition of rhythm, recognition of adequate therapy, follow-up of the protocol concerning~     DC-shock recording the exact moment of the following procedures (with the use of Code Marker~     button on the defibrillator device) endotracheal intubation drug therapy obtaining~     intravenous access oxygen therapy~      Quality of chest compressions:~      depth frequency release compression fraction~      Discontinuance of chest compression - cause anf time interval (Code Marker) endotracheal~     intubation ventilation rhythm analysis and defibrillation obtaining intravenous access~      Other data (obtaining with manual recording):~      cause of sudden cardiac death initial rhythm exact time of sudden death eyewitness records~     data of the patient monitoring system (only optional) description of place participant of CPR~     first detection medical documentation~   "
34694|NCT03112447|"~     To compare surgical outcomes from medial epicondyle fracture fixation with absorbable~     cartilage nails to those from traditional Kirschner wire fixation.~   "
34695|NCT03112434|"~     To date, clinical tests are unable to differentiate between the cause of muscle stiffness,~     although a manual instrumented spasticity assessment for the lower limb that utilizes surface~     electromyogram has recently been proposed. This study intends to use shear wave elastography~     to assess individual muscle stiffness parameters and the individual response to botulinum~     toxin injection in the elbow and wrist flexors. Collection of baseline spasticity parameters~     could then be used to predict the effect of botulinum toxin type A and ultimately serve as a~     basis for development of a treatment model for muscle spasticity in patients with spastic~     cerebral palsy.~   "
34706|NCT03112291|"~     The aim of this study was to perform a clinical and microbiological evaluation of teeth with~     incomplete apexogenesis and traumatic necrosis that were treated with a revascularization~     technique, evaluating the microbial reduction after the use a double antibiotic paste.~     Furthermore, the investigation also aims to identify the presence of Enterococcus faecalis~     and Porphyromomas gingivalis within the root canal system.~   "
34696|NCT03112421|"~     Sample Comparison The objective of this study is to compare the Philips Minicare BNP test~     with the Centaur BNP test. BNP level measured in human blood samples (EDTA venous whole blood~     and/or EDTA plasma) will be assessed. Matrix Comparison To compare BNP measurements obtained~     using Minicare System for EDTA whole blood and EDTA plasma samples.Prior to the study start,~     a proficiency study will be performed on the Minicare BNP, Architect and I-STAT BNP assay to~     be sure that devices are performing according to expectations. Approximately 100 EDTA patient~     whole blood samples covering the entire measuring range of Minicare BNP from LOQ until end of~     measuring range (expected to be approximately 5000 ng/L) (Ref 7) will be tested (according to~     CLSI EP09A3 (Ref 5)) at a central laboratory using the Minicare BNP, Alere BNP, I-STAT BNP~     system. The outcome of the site routine assay (Centaur BNP systems) will be used to evaluate~     if the blood samples cover the entire distribution range of the assay. If necessary, up to~     20% of the samples may be spiked so that the entire range of the assay is covered. The~     central laboratory will identify the blood tubes with a BNP request. Approximately 1000 μl~     EDTA whole blood will be available (left over material) for testing on the non-routine~     devices (i.e., Minicare BNP, Alere BNP, and I-STAT BNP). Testing for the Alere BNP, I-STAT~     BNP, and Centaur BNP systems will be performed according to the respective IFU's (Ref 1, 2,~     3, 4). For the Minicare BNP system, test will be performed according to a DRAFT IFU or a~     similar document describing the sample treatment and handling for the Minicare BNP system.~     Alere BNP, I-STAT BNP and Minicare BNP samples should be tested within 6 hours after~     collection and Centaur BNP samples within 8h of collection. Although different stability~     claims for BNP, it is highly recommended to perform all measurements on all systems within 2~     hours. For Alere BNP, I-STAT BNP, Centaur BNP analysis will be performed using a single blood~     sample for each patient. Alere BNP and I-STAT will use EDTA whole blood samples as sample~     type Centaur BNP will be tested on EDTA plasma samples. For the Minicare BNP, both EDTA whole~     blood and EDTA plasma will be tested for each patient. For the Minicare BNP system the whole~     blood samples will be tested using a pipette and the same sample will be tested using the~     SmearSafe Blood Dispenser (transfer device) to investigate a reliable use of such transfer~     device.~      Only the routine Centaur BNP outcomes will be used as part of support for patient diagnosis.~   "
34697|NCT03112408|"~     This research aims to highlight the key roles of the cerebellar and cortical fronto-parietal~     networks in the coupling of eye movements with visual perception and visuo-spatial attention.~   "
34698|NCT03112395|"~     The demographic shift and the increasing prevalence of chronic wounds represent major~     challenges for modern health care systems. Classic chronic wounds (venous ulcer, arterial~     ulcer, mixed ulcer, diabetic foot ulcer) persist for months or years with a very slow or even~     no healing progress. Patients suffer from pain and immobility, which dramatically reduces~     their quality of life. Complications such as infections or tissue necrosis can lead to a bad~     outcome and amputation of extremities.~      The Pio device offers a non-invasive and non-toxic therapeutic approach. The system combines~     the technologies of pulse modulated magnetic fields and light emission locally applied to the~     wound area. The investigational medical device represents a promising combinational~     therapeutic approach to synergistically increase the tissues regenerative potential. By~     stimulating electrophysiological processes at the site of injury, the cells regain its~     capacity to efficiently regenerate the injured or diseased tissue. It is expected that the~     patient benefits from a faster healing process, reduced inflammation as well as an improved~     overall treatment outcome.~   "
34699|NCT03112382|"~     Study whether SLC30A8 rs13266634 polymorphism is associated with type 2 diabetes mellitus~     (T2DM) susceptibility in Egyptian patients and study effect of Zn supplementation on glycemic~     control in patients with type 2 diabetes~   "
34700|NCT03112369|"~     Investigators will conduct a two-arm, comparative effectiveness randomized controlled trial~     of two culturally adapted, empirically based programs (EBP) - Narrative Exposure Therapy~     (NET) vs. Motivational Interviewing with Skills Training (MIST) in terms of lowering HIV~     sexual-risk behaviors (HSB) for American Indian / Alaska Native (AIAN) men and women. NET~     addresses Posttraumatic Stress Disorder (PTSD) as a pathway to preventing substance use~     disorders (SUD) and HSB whereas MIST addresses substance misuse as a way of preventing SUD~     and HSB.~   "
34701|NCT03112356|"~     Infectious endocarditis is a serious pathology with difficult diagnosis especially on~     prosthetic valves or cardiac device because of the plurality of clinical presentations and~     the low sensitivity value of echocardiography in these patients. Despite a well validated~     indication for the detection of septic emboli, the value of FDG-PET for the detection of~     prosthetic valves or cardiac implantable device is still unclear especially because of~     frequent non-septic inflammatory processes.~      To improve the specificity value, the use of radio-labeled leukocytes scintigraphy is~     conventionally proposed. An alternative method is to label leukocytes in vivo with an~     anti-murin anti body fragment ( Sulesomab , Leukoscan®). This scintigraphy is regularly used~     in the investigation of osteomyelitis and has been proposed in infectious endocarditis. To~     knowledge of investigators, the value of Leukoscan® scintigraphy on prosthetic valve or~     cardiac device infection had not been studied.~   "
34702|NCT03112343|"~     This is a 24-week, open-label, randomized, multi-center trial conducted in three tertiary~     hospitals. There are three follow-up measures; at baseline, post-intervention at Week 12, and~     Week 24. Subjects are diagnosed as type 1 DM, type 2 DM, and/or post-transplant DM, and~     initiate or currently use insulin therapy. After the given education on insulin dose~     titration and prevention for hypoglycemia and 1 week of run-in period, subjects are~     randomized in a 1:1 ratio to either the ICT-based intervention group or the conventional~     intervention group. Subjects in conventional intervention group will save and send their~     health information to the server via the PHR app, whereas those in ICT-based intervention~     group have additional algorithm-based feedback messages. The health information includes~     levels of blood glucose, insulin dose, details on hypoglycemia, food diary, and number of~     steps. The primary outcome will be the proportion of patients who reach an optimal insulin~     dose within 12 weeks of enrolling in the study without severe hypoglycemia or unscheduled~     clinic visits.~      This study is based upon work supported by the Ministry of Trade, Industry & Energy (MOTIE,~     Korea) under Industrial Technology Innovation Program (No. 10059066, 'Establishment of ICT~     Clinical Trial System and Foundation for Industrialization.)~   "
34703|NCT03112330|"~     The goal of the suggested research is to develop a treatment option using platelet rich~     plasma injection for regeneration of atropic nasal mucosa.~      Specific aims of the suggested research is to (1) access the effect of platelet rich plasma~     in the patients with atropic rhinitis . Moreover, we will (2) compare the conservative~     treatments including saline nasal irrigation or saline nasal spray.~   "
34704|NCT03112317|"~     This study investigate associations between mild hypothermia (patients' core temperature ≤~     36.0 degrees Celsius) and intra-operative blood loss and surgical site infections (SSI) in~     patients undergoing major abdominal surgery.~   "
34705|NCT03112304|"~     The overarching goal of this project is to study the sustainability of MATCH-ADTC within~     community mental health clinics, to learn what is needed for evidence-based practices (EBPs)~     to take root and thrive within a public system.~   "
35170|NCT03106233|"~     The lateral thigh perforator (LTP) flap was previously introduced as an alternative flap for~     autologous breast reconstruction when the abdomen is not suitable as a donor site. In this~     prospective study all LTP flap breast reconstructions that have been performed since~     September 2012 are analyzed. In addition, the surgical refinements that were introduced over~     the years are reported.~   "
34712|NCT03112213|"~     This nationwide, multicenter, single arm, prospective, non-interventional study will evaluate~     the quantitative pattern of NSAID use and the impact of treatment with tocilizumab on NSAID~     use in a representative cohort of participant with moderate to severe active RA who have~     either responded inadequately to, or who were intolerant to previous therapy with one or more~     synthetic disease modifying anti-rheumatic drug (sDMARD), and for whom the physician has made~     the individual decision to initiate tocilizumab (subcutaneous [SC] or intravenous [IV]) as~     first biological disease modifying anti-rheumatic drug (DMARD) therapy according to the~     summary of product characteristics (SPC).~   "
34713|NCT03112200|"~     This is a multi-center, prospective, single-blinded, two-arm study, randomized to include 134~     subjects treated with Subchondroplasty (SCP) + Arthroscopy and 67 subjects with arthroscopy~     alone.~      The primary objective of this study is to demonstrate superiority of Subchondroplasty with~     arthroscopy compared to arthroscopy alone for treatment of Bone Marrow Lesions (BMLs) in the~     knee.~   "
34714|NCT03112187|"~     To evaluate the efficacy of a novel food supplement, Ferfer® to raise the capacity of~     Haemoglobin and Haematocrit levels~   "
34715|NCT03112174|"~     This Phase 3 multinational, randomized, double-blind study is designed to compare the~     efficacy and safety of the combination of ibrutinib and venetoclax vs. ibrutinib and placebo~     in subjects with MCL.~   "
34716|NCT03112161|"~     This study will determine whether changes in energy balance alter regional neuronal~     activation of brain regions associated with food intake in individuals screened to be either~     resistant or prone to obesity. Specifically, it will determine whether foods of hedonic~     value elicit changes in regional neuronal activity in the fasted and fed state in~     obese-resistant and obese-prone men and women in varying states of energy balance.~   "
34717|NCT03112148|"~     This is a Phase 1, randomized, open label, 4-period, 6-sequence, partial cross-over,~     single-dose study to evaluate the PK of age-appropriate tofacitinib MR formulations (release~     rates: MR-Slow, MR-Moderate, and MR-Fast) compared to tofacitinib IR solution under fasting~     conditions. The effect of food on the PK of MR-Slow and MR-Fast will also be assessed.~   "
34718|NCT03112135|"~     The effect of tranexamic acid (TXA) on bleeding and improvement of surgical field during ear~     exploration surgery is not clear yet. This study will conducted to answer this question.~   "
34719|NCT03112122|"~     Randomized, controlled, three-arm, double-blind study : control group, treated with core~     decompression technique VS subchondral plasty by injecting i-FactorTM VS injections of~     autologous BMC.~   "
34720|NCT03112109|"~     Against the background of the European Innovation Partnership on Active & Healthy Ageing,~     SmartCare aims to define a common set of standard functional specifications for an open ICT~     platform enabling the delivery of integrated care to older European citizens.~      In the context of SmartCare, a total of 23 regions and their key stakeholders will define a~     comprehensive set of integration building blocks around the challenges of data-sharing,~     coordination and communication. Nine regions will then deploy integrated health & social~     services to combat a range of threats to independent living commonly faced by older people,~     while the others will prepare for early adoption, possibly in the framework of new ICT PSP~     projects. In a rigorous evaluation approach, the deployment sites will produce and document~     much needed evidence on the impact of integrated care, developing a common framework suitable~     for other regions in Europe. The organisational and legal ramifications of integrated care~     will be analysed to support long term sustainability and upscaling of the services.~      SmartCare services will provide full support to cooperative delivery of care, integrated with~     self-care and across organisational silos, including essential coordination tools such as~     shared data access, care pathway design and execution, as well as real time communication~     support to care teams and multi-organisation access to home platforms. In addition, they will~     empower all older people according to their mental faculties to take part in effective~     management of their health, wellness, and chronic conditions, and maintain their independence~     despite increasing frailty.~      The SmartCare services build on advanced ICT already deployed in the pioneer regions,~     including high penetrations of telecare and telemonitoring home platforms. In SmartCare,~     these platforms are to be opened to cross-sectorial care teams, improving the ability of~     older people to better manage their chronic conditions at home and deal with their increasing~     frailty. System integration will be based, whenever possible, on open standards' multivendor~     interoperability will be strongly encouraged.~   "
34721|NCT03112096|"~     This is a study to evaluate biodistribution, pharmacokinetics and safety of [18F]THK-5351~     positron emission computed tomography in Cognitively Healthy Subjects and Patients with~     Alzheimer's Disease.~   "
34722|NCT03112083|"~     The aim of this study was to systematically collect data on safety and tolerability of krill~     powder in humans and simultaneously gain efficacy data by measuring the risk factors for~     cardiovascular disease.~      The study was a randomised, double-blinded, placebo-controlled intervention study with~     slightly obese subjects with mildly or moderately elevated blood pressure. Study was~     conducted at two study sites in Central (Tampere) and Northern Finland (Oulu). In total 35~     subjects were randomised according to randomisation list to two groups (krill powder or~     placebo) in a balanced manner (1:1), separately for both gender and site. Concealed~     allocation was used to keep both subjects and staff blinded. The study consisted of a~     pre-screening, Day -7-(-14) screening visit, Day 0 baseline (Randomization visit) and 8-week~     safety and tolerance follow-up period with three follow-up visits on Day 14, Day 28 and Day~     56.~      As a primary endpoint of the study, the total number of reported adverse events were compared~     in the study subject groups taking 8 capsules (4 g) krill oil powder or 8 capsules (4 g) of~     placebo for the 8-week follow-up period.~   "
34723|NCT03112070|"~     Hypertension is the most prevalent cardiovascular disease risk factor among individuals 60~     years of age and older. Hypertension can be prevented and modified with lifestyle~     interventions that include regular exercise. Water exercise is widely recommended for older~     adults for a variety of health benefits, but few studies have assessed the immediate~     ambulatory blood pressure (BP) response to water exercise, a response termed postexercise~     hypotension (PEH). We will assess PEH after a session of water aerobics in physically active,~     older women with hypertension. Twenty-four women will be randomly assign to participate in a~     45 min session of moderate intensity, water aerobics (WATER) and a 45 min land control~     session (CONTROL). All experimental sessions will start at 9 am sharply with 7 days between~     them. Subjects will left the experiments wearing an ambulatory BP monitor for the next 21 hr.~   "
34724|NCT03112057|"~     The purpose of this experiment is to establish a solid medical foundation for the successful~     development of non-invasive harmonic generation (HGM) microscopic slicing methods. The~     purpose of this new technology platform is to directly observe the nerve endings of~     nociceptors To enhance understanding of how neuropathies occur, persistence, and ease. This~     technique will assist in the diagnosis and prognosis of patients with neuralgia.~   "
35191|NCT03105960|"~     the study about herbal mouthwash. it is clinical trial .the investigator will compare between~     chlorhexidine mouthwash and garlic with lime juice mouthwash.and their effect on gingival~     bleeding and plaque and salivary bacteria.~   "
34725|NCT03112044|"~     In this study HCV negative recipients will be transplanted with HCV positive lungs.~     Investigators will attempt to decrease infectivity rates by performing Normothermic Ex vivo~     Lung Perfusion (EVLP), which is an approved method of donor lung preservation, assessment and~     treatment, and could be an excellent platform to reduce/eliminate hepatitis C virus. Patients~     will be treated by the standard approved direct-acting antivirals (DAAs) if infection occurs.~     It is planned to enrolled 20 patients from the Lung transplant wait list in this study.~     Patients will be followed for 6 months. This will be a single center pilot study.~   "
34726|NCT03112031|"~     The purpose of this study is to develop initial efficacy, feasibility, and safety data~     regarding the use of Tamoxifen in combination with amphotericin B and fluconazole in the~     treatment of cryptococcal meningitis. The results of the study will inform the design and~     feasibility of a larger study powered to a survival endpoint. The study hypothesis is that~     adding tamoxifen to standard antifungal therapy increases the rate of clearance of yeast from~     cerebrospinal fluid. Increased rates of clearance of yeast from cerebrospinal fluid have~     previously been associated with improved clinical outcomes, including survival and~     disability.~   "
34727|NCT03112018|"~     The purpose of this study is to determine whether a combination of evidence-based strategies~     can improve intrapartum and newborn care in facilities to reduce mortality among preterm~     infants. This will be a cluster randomized implementation science study across 23 facilities~     in Eastern Uganda and Western Kenya. Selected interventions will be supported in facilities~     to measure impact during the study period. These interventions are: a) data strengthening and~     data use activities; b) implementation of a modified WHO Safe Childbirth Checklist with an~     emphasis on preterm labor and preterm babies; c) simulation-based provider training and~     mentoring on key existing evidence-based practices to improve newborn outcomes; d) support of~     Quality Improvement (QI) cycles to identify and resolve facility-specific issues and~     bottlenecks. A two-stage design will be used where all study facilities will receive some~     aspects of the intervention initially, namely data strengthening and the modified checklist.~     Subsequently, the remaining interventions (QI cycles and simulation training of providers)~     will be rolled out to a randomly selected half of the facilities in the first stage. At a~     second stage, the remaining half of the facilities will receive the remaining interventions.~   "
34728|NCT03112005|"~     More than 29 million people in the US are living with diabetes, many of whom will develop~     diabetic retinopathy (DR) or diabetic macular edema (DME) collectively known as diabetic eye~     disease (DED), the leading cause of vision loss and blindness in working-age adults. Annual~     eye screening is recommended for all diabetic patients since vision loss can be prevented~     with laser photocoagulation and anti-VEGF treatment if DR is diagnosed in its early stages.~     Currently, the number of clinical personnel trained for DR screening is orders of magnitude~     smaller than that needed to screen the large, growing diabetic population. Therefore, to meet~     this large unmet need for DR screening, a fully-automated computerized DR screening system is~     necessary.~      EyeArt is an automated screening device designed automatically analyze color fundus~     photographs of diabetic patients to identify patients with referable or vision threatening~     DED. This study is designed to assess the safety and efficacy of EyeArt.~   "
34729|NCT03111992|"~     The purpose of this study is to assess the safety, tolerability, and identify the recommended~     doses of single agent CJM112, and of CJM112 or LCL161 in combination with PDR001, in patients~     with relapsed and/or refractory multiple myeloma.~   "
34730|NCT03111979|"~     The older population is the fastest growing age group worldwide, but it is also the most~     susceptible to chronic diseases and disabilities. One of the most common negative~     consequences of aging is the decline in muscle mass, strength and power. This is most notable~     in lower limb muscles. These muscles are required for the performance of daily activities~     including walking, stair climbing and standing up from sitting. Regular exercise is~     considered one of the most effective measures to slow, and even reverse the progression of~     muscle weakness. Nevertheless older adults may notice a decline in their capability to~     undertake regular exercises, this may be due to a decline in their muscle's ability to buffer~     pH. Carnosine (made by bonding β-alanine and histidine) has been suggested to contribute to~     the extension of physical performance, counteracting the decline the muscle's ability to~     buffer pH. Yet this pH buffering process it largely restricted by the amount of β-alanine~     available in the human body. β-alanine is already known to decline in older individuals due~     to a reduction in food products (meat, fish and poultry). Yet through either consumption of~     β-alanine rich food, or through short-term supplementation, β-alanine is raised, increasing~     carnosine concentrations. Improved β-alanine levels can potentially advance exercise~     performance, for example significant improvements in time to exhaustion on both a constant~     (37%) and incremental (12%) treadmill tests have been demonstrated. It is therefore proposed~     that via β-alanine supplementation, an individual's perception of their frailty, maintenance~     of health and independent living can be improved in older individuals.~      However, these findings are based on participants, both young and older, who are well-rested~     with no prior exercise or fatigue to the assessed muscles. It remains unclear if β-alanine~     supplementation will aid in the buffering of pH when the muscle has already been fatigued.~     Therefore this investigation hopes to examine the effects of 4 week β-alanine supplementation~     on lower limb contractile and force properties, pre and post muscle specific fatigue.~   "
34731|NCT03111966|"~     This is a multicentre, descriptive, observational and ambispective study carried out in~     patients who are treated with Elbasvir/Grazoprevir in hospitals that included their data in~     Hepa-C Registry (directed by the Spanish Association for the Study of the Liver and the~     Networked Biomedical Research Centre for Hepatic and Digestive Diseases).~   "
34732|NCT03111953|"~     Biliopancreatic diversion (BPD) surgery results in greater resolution of type 2 diabetes than~     all other bariatric surgical procedures, and it is hypothesized that this procedure has~     specific beneficial effects on glucose homeostasis beyond weight loss alone. The BPD~     procedure is performed in more than 150 patients/year by surgeons at the Division of Obesity~     and Metabolic Disorders, Catholic University of the Sacred Heart, School of Medicine, in~     Rome, Italy. The purpose of this study is to provide a better understanding of the effect of~     the BPD bariatric surgical procedure on insulin action and pancreatic beta cell function. It~     is hypothesized that weight loss achieved with BPD surgery will have greater effects on~     insulin sensitivity and beta cell function than weight loss induced by Roux-en-Y gastric~     bypass (RYGB).~   "
34759|NCT03111602|"~     INCREASE OF PROSTAGLANDIN E2 IN REVERSAL OF DUCTAL CONSTRICTION AFTER DIETARY RESTRICTION OF~     POLYPHENOLS.~      Clinical trial with a healthy group as comparator. The interventional group was made up of~     third-trimester mothers whose single fetuses had ductal constriction, excluding those exposed~     to NSAID, and the control group only by third-trimester normal fetuses. The interventional~     group was submitted to dietary orientation to restrict polyphenol-rich foods and both groups~     answered a food frequency questionnaire after fetal Doppler-echocardiographic examination and~     blood draw for PGE2 levels analysis. After two weeks, the women were again submitted to fetal~     echocardiogram, dietary assessment and blood draw.~   "
34760|NCT03111589|"~     Sickle cell disease (SCD) is an autosomal recessive disorder resulting from a substitution in~     the β chain of hemoglobin (Hb) which causes hemoglobin S to polymerize when deoxygenated. SCD~     patients present immune abnormalities that have always been attributed to functional~     asplenia. It it is now being recognized that patients with SCD have a pro-inflammatory~     condition with altered immune system activation contributing to the pathology of SCD.~     Increased levels of neutrophils, monocytes or cytokines have been reported in SCD patients.~      SCD is associated with many acute and chronic complications requiring immediate support.~     Actual strongly recommended therapies include chronic blood transfusions (CT) and hydroxyurea~     (HU). In addition, episodic transfusions are recommended and commonly used to manage many~     acute SCD complications.There is strong evidence to support the use of HU in adults with 3 or~     more severe vaso-occlusive crises during any 12-month period, with SCD pain or chronic~     anemia, or with severe or recurrent episodes of acute chest syndrome. HU use is now also~     common in children with SCD. Some patients receive chronic monthly RBC transfusion with the~     objective to reduce the proportion of HbS to < 30 %. Long-term RBC transfusions prevent and~     treat complications of SCD decreasing the risk of stroke and the incidence of acute chest~     syndrome (ACS).~      Therapeutic complications, such as alloimmunization against RBC in 20-50% of patients or~     hematopoietic stem cell transplantation (HSCT) graft rejection, constitute an immune-based~     clinical issue in SCD. Poorly understood RBC alloimmunization is responsible for serious~     hemolytic transfusion reaction associated with severe mortality and morbidity underlying the~     need for a better understanding of the immunology of SCD to improve SCD transfusion~     support/outcome. Little evidence exists about HU effects on immune functions in SCD. HU~     treatment doesn't appear to have deleterious effects on immune function and appears to~     decrease the abnormally elevated number of total WBC and lymphocytes, while CT does not.~      Patients with SCD are at higher risk of infections and prophylactic vaccination is strongly~     recommended. Recent data suggest that vaccinal response to pneumococcal antigens in SCD~     patients is identical to healthy control while controversy concern the stability of the~     immune protection after vaccination of SCD patient. Antibody levels declined over the year~     and the need for more frequent vaccination in SCD patient should be investigated. Currently,~     there is no evidence whether HU may interfere with pneumococcal immune response. Purohit~     showed that immune response to inactivated influenza A (H1N1) virus vaccine was altered in~     patient with SCD receiving CT but little is known on immune response to vaccination in~     patients with SCD receiving HU.~      Recent data suggest that not only inflammatory status but also humoral immune response to~     antigens in SCD patients may differ according to treatment. Yazdanbakhsh reported an~     imbalance between regulatory T cell (Treg) and effector T cell (Teff) in alloimmunized SCD~     patients with as consequence an increase in antibody production. In a model proposed by the~     authors, the balance between Treg and Teff is dictated by the monocyte control of cytokines~     expression. Altered activity of monocyte heme oxidase-1 (HO-1) would be responsible of a~     decrease in IL-12 and an increase in IL-10 cytokines secretion impacting the Treg/Teff cells~     ratio and promoting antibody production by B cells.~      The objectives of the project are to assess whether different humoral immune responses to~     vaccines or to erythrocyte alloantigens are related to the type of treatment administered to~     patients with SCD. We also aim to study if these differences might be related to different~     expressions of HO-1 by monocytes.~   "
34733|NCT03111940|"~     The OxOPT-PCI study addresses patients with coronary artery disease who are referred to the~     John Radcliffe Hospital because of the need for treatment with an intra-coronary stent (metal~     scaffold) for clinical reasons. Although, this has become a highly standardised procedure it~     is still challenging for the clinician to assess the final success of this procedure at the~     end of intervention with conventional methods. This shortcoming can potentially translate~     into a worse clinical outcome for approximately 10 percent of all patients treated with an~     intra-coronary stent for this type of disease.~      This study (OxOPT-PCI) investigates if the use of blood flow measurements (namely measurement~     of fractional flow reserve (FFR)) and intravascular imaging (namely optical coherence~     tomography (OCT)) after the implantation of a stent can improve the treatment result for~     these patients. Both, FFR and OCT are being used already in daily clinical routing but their~     usefulness especially in combination is not clear. In order to standardise the optimisation~     procedure we developed a specific algorithm to make sure that all patients receive the same~     optimisation measures based on the assessment of FFR and OCT.~      The benefit of this specific optimisation algorithm will be assessed by measuring 1) indices~     of coronary blood flow, 2) intravascular imaging at the end of the procedure, and 3) by~     contacting the patients 12 months after stenting to verify the clinical mid-term success.~   "
34734|NCT03111927|"~     Research study on the role of early life nutrition on brain and cognitive development during~     infancy and early childhood. Two blends of myelin-relevant nutrients at different levels will~     be compared and a breastfed group will be considered as epidemiological reference.~   "
34735|NCT03111914|"~     The purpose of this study is to establish a more accurate and precise way to image (take~     pictures of) metastatic bone disease in patients with prostate cancer for staging and~     monitoring response to therapy. More specifically, the study aims to evaluate the~     capabilities of dual energy CT as a more precise and accurate tool for staging and monitoring~     of therapy response in patients with osseous metastases from castrate-resistant prostate~     cancer.~      Bone metastases in prostate cancer patients are a clinical and diagnostic challenge to image.~     Sometimes very small metastatic bone lesions may only become detectable by imaging in~     response to therapy due to increased bone deposition during the first three months after~     therapy. Commonly used imaging tests (such as regular CT or bone scan) are unable to reliably~     tell the difference between increased bone deposition (therapy response) and growth of the~     lesion (progressive disease). This diagnostic challenge may have profound negative effects on~     patient management since it may require additional imaging before an accurate determination~     of tumor response can be made. An appropriate determination of tumor response is needed for~     appropriate management of prostate cancer. The investigators anticipate that the new imaging~     tested in this study (called dual energy CT) may provide additional critical information in~     this clinical and diagnostic challenge.~      Approximately 100 people with prostate cancer and metastatic bone disease will take part in~     this study. At enrollment, three months, and six months, they will will receive a~     non-enhanced (without contrast) dual energy CT scan of the chest, abdomen and pelvis before~     receiving their routine, clinical contrast-enhanced CT scan.~   "
34736|NCT03111901|"~     This study will evaluate the safety and disease control rate of the combination of~     pembrolizumab plus low-dose interleukin-2 in patients who have either advanced melanoma or~     renal cell cancer.~   "
34737|NCT03111888|"~     The goal of the small feasibility trial is to establish a method, material, and~     patient-specific design that is superior to what is in use today. The first round of patients~     are well known to the physician investigator and are familiar with the problem that is being~     resolved. The end goal of the project is to create a new patient-specific design that will~     last longer, fit better, and cause less trauma to the airway and the patient.~   "
34738|NCT03111875|"~     We propose to test the hypothesis that aggressive warming reduces the incidence of major~     cardiovascular complications, compared to routine care. Half of the participants will be~     randomly assigned to routine care (core temperature ≈35.5°C), while the other half will~     receive aggressive warming (>37°C core temperature) in a multi-center trial.~   "
34739|NCT03111862|"~     The aim of this observational study registry is to assess the safety of a Non-ST-elevation~     myocardial infarction (STEMI) rapid rule-out strategy as proposed by European Guidelines in~     patients presenting with suspected acute coronary syndrome to the emergency department.~   "
34740|NCT03111849|"~     The prevalence of sarcopenia is high in many organ pathologies such as COPD, but remains~     little studied in acute respiratory failure. Sarcopenia is a health problem representative of~     frailty, loss of autonomy and decreased muscle strength. The frequency and evolution of~     sarcopenia is unknown in patients having chronic bronchic obstruction with exacerbation.~   "
34741|NCT03111836|"~     Hypertension is a leading risk factor for cardiovascular disease and mortality. Lifestyle~     counseling is recommended as a first line therapy for reducing blood pressure (BP) and risk~     for cardiovascular events. Recent studies suggest that e-based lifestyle interventions are~     effective in evoking therapeutic change in BP1. However, BP response and adherence to~     exercise and diet behavior varies significantly after e-based interventions due to variations~     in treatment methodologies. Consensus is not yet established for a standardized e-counseling~     protocol for hypertension. As noted in our systematic review, the two dominant models of~     e-counseling procedures are expert-driven (protocol driven, prescriptive) and user-driven~     (self-guided, collaborative). Expert-driven programs prescribe specific changes for lifestyle~     behavior which are intended to facilitate compliance to behavioral change. In contrast, the~     user-driven method actively involves the subject in goal-setting and/or the selection of the~     intervention used to reach the behavioral goal. One conclusion from the systematic review is~     that these models are used indiscriminately in e-counseling programs. There is currently~     inadequate data to determine the efficacy of programs that are expert-driven vs. user-driven~     in reducing BP while modifying lifestyle behaviour. It is possible that a combination of~     expert-driven and user-driven features for lifestyle e-counseling is most effective. However,~     before these two approaches can be combined, it is essential to establish the strengths and~     limitations of each model.~   "
34742|NCT03111823|"~     This pilot clinical trial studies how well aerobic exercise works in improving quality of~     life and health-related outcomes in patients with stage IV colorectal cancer undergoing~     chemotherapy. Aerobic exercise during chemotherapy may improve quality of life and reduce~     fatigue and inflammation in the blood related to heart disease and diabetes in patients with~     stage IV colorectal cancer.~   "
34743|NCT03111810|"~     Currently, 2-3% of the population of the United Kingdom and United States of America receive~     glucocorticoid therapy. Significant adverse effects are not confined to chronic use;~     recurrent short-course administration is associated with increased morbidity and mortality.~     The adverse metabolic features associated with glucocorticoid use include obesity, skeletal~     muscle myopathy, hypertension, insulin resistance and diabetes and are collectively termed~     'iatrogenic Cushing's syndrome'. The efficacy of glucocorticoid therapy is not in doubt, but~     there are no interventions to reduce their metabolic consequences. Within metabolic tissues~     (liver, skeletal muscle, adipose), 11β-hydroxysteroid dehydrogenase type 1 (11β-HSD1)~     regenerates active glucocorticoid and therefore is able to tightly control the availability~     of glucocorticoids to activate the glucocorticoid receptor. In preclinical studies, the~     investigators have shown that 11β-HSD1 is critical in regulating the development of the~     adverse features associated with circulating glucocorticoid excess, endorsing our~     observations in a patient with Cushing's disease, who was protected from a classical~     phenotype due to a functional deficit in 11β-HSD1.~      This study is the first clinical evaluation of the impact of the selective 11β-HSD1~     inhibitor, AZD4017, in healthy volunteers taking exogenous glucocorticoids (prednisolone).~     The investigators propose that in tissues expressing high levels of 11β-HSD1, prednisolone~     action will be amplified, driving adverse effects within these tissues and have hypothesized~     that AZD4017 in humans will reduce the adverse metabolic consequences of Prednisolone~     administration without compromise to its anti-inflammatory action.~      Our specific research objectives are:~        1. To demonstrate the beneficial effect of the selective 11β-HSD1 inhibitor, AZD4017, upon~          the prednisolone-induced deterioration in metabolic phenotype, including glucose~          disposal and endogenous glucose production rates.~        2. To determine the impact of AZD4017 on the anti-inflammatory actions of Prednisolone.~        3. To identify the tissue-specific (skeletal muscle, adipose) mechanisms underpinning the~          response to Prednisolone therapy administered in conjunction with AZD4017.~      The investigators will perform a randomized, double-blind placebo controlled study to~     determine if co-administration of the selective 11β-HSD1 inhibitor, AZD4017, limits the~     adverse effects of short-course exogenous glucocorticoid administration. 32 healthy male~     volunteers will have detailed metabolic investigations including 2-step hyperinsulinaemic~     euglycaemic clamps (with stable isotope measurements of lipid and carbohydrate metabolism),~     as well as assessment of skeletal muscle forearm glucose uptake. All volunteers will then be~     treated with Prednisolone (20mg daily) and randomized to the co-administration of placebo or~     AZD4017. After 1 week of therapy, all investigations will be repeated. Our hypothesis is that~     the adverse metabolic effects of Prednisolone will be reduced by co-administration of~     AZD4017.~   "
34744|NCT03111797|"~     This prospective and observational cohort studies the morphine consumption difference during~     the first 48 hours after a lung lobectomy between patients operated with a robot assisted or~     a video-assisted technique for a lung cancer lobectomy.~      Second outcome was to search eventual cardiac output difference during the surgery in 100~     patients (50 in each group) using a non invasive monitoring device of cardiac output~      All patients operated between january 2016 and March 2017 for a lung cancer lobectomy were~     included.~   "
34745|NCT03111784|"~     IConsumption of fish provides a vital contribution to the survival and health of a~     significant portion of the world's population. Lipids in fish foods consist mainly of~     long-chain polyunsaturated fatty acids (PUFAs) such as eicosapentaenic acid (EPA, C20:5n-3)~     and docosahexaenoic acid (DHA C22:6n-3) which belongs to the physiologically important group~     of n-3 fatty acids. The increase of unsaturated fatty acids, along with the reduction of~     saturated fats, supports the lowering of blood cholesterol in humans and causes a positive~     impact on human nutrition. Polyunsaturated fatty acids (omega-3 fatty acids) plays a role in~     preventing heart disease and has anti-inflammatory and anti-thrombosis effects and these~     fatty acids cannot be synthesized and they must be obtained through diet. These nutritional~     benefits of fish consumption is mainly attributed to the effect of omega-3 polyunsaturated~     fatty acids , which are thought to have several potential cardio protective actions. This~     research is focused mainly identify highly consumed food fishes available in Batticaloa~     district( fresh, lagoon and sea water ) and their consumption pattern (cooking methods) of~     local community and by cardiovascular patients (CV) . Secondly Omega-3- Polyunsaturated fatty~     acid (PUFA) and tocopherol content (Vit E) in the fresh fish and dried or smoked fish of the~     highly consumed food fishes would be assessed and the relationship between fish consumption~     and its PUFA and Vit E content would be known. Also research will focus how lifestyle,~     socio-demographic factors' influences on the Cardiovascular diseases among community.~   "
34746|NCT03111771|"~     Loss of muscle mass (scientific term: cachexia) affects about 80% of patients with advanced~     cancer and impacts their prognosis by decreasing tolerance and response to treatment,~     decreasing quality of life and survival. The prognosis in these patients depends directly on~     the importance of the loss of muscle mass. Preserving it is therefore an essential~     therapeutic objective. It is therefore important to understand perfectly the mechanism of~     this muscular loss. The accumulation of fat in the muscle (scientific term: myosteatosis)~     could be a mechanism responsible for this loss of muscle mass. It is indeed a hypothesis~     proved on animal models. Moreover, it has recently been shown that more the cancer patient~     loses weight, more his muscle contains fat. This lets think that this deposit of fat in the~     muscle would be directly related to the loss of muscle mass. All of these observations could~     not be clearly established in humans and investigators are seeking by this study to~     illuminate these mechanisms at the human level. A better understanding of these mechanisms~     would allow investigator to set up targeted treatments against the accumulation of fat in the~     muscle, which would significantly improve the quality of life of patients with cancer of the~     aerodigestive pathways and their chances of recovery.~      The MYOMEC study includes the inclusion of healthy patients (to form a control group) but~     also patients with cancer of the upper aero-digestive tract. The study will be divided into~     two parts: clinical examination and nutritional evaluation the day before surgery at the time~     of the participants' admission to hospital and then the biological samples during surgery.~     The nutritional examination consists in collecting the morphological data of the patient,~     namely:~      Its weight, size, calculation of the body mass index Tests of muscular strength (wearing~     weight of 1, 2 and 3 kilos) Measurement of the percentage of fat mass and lean mass~     (Impedancemetry)~      In this study, participants benefit from the following investigations:~        -  Clinical examination complete with elaboration of the clinical nutritional status,~          realized the day before the surgical intervention in hospitalization.~        -  Elaboration of the radiological nutritional status by a complementary analysis of the~          scanner envisaged in the balance of extension of the disease~        -  Performing surgical site sampling during surgery without additional invasive procedure~          and under general anesthesia. It will be realized:~      A muscle biopsy of the sterno-cleido-mastoid muscle (neck muscle) (maximum volume 5 mm3), A~     tumor biopsy (maximum volume 5mm3). A blood sample (maximum volume 5ml)~      No invasive procedure, supplemental examination or additional consultation is required for~     the whole off-set study for the extensive muscular percutaneous biopsy regarding which~     additional patient agreement will be required. No additional follow-up is required when~     participating in this study. Participation in this study does not entail any particular~     constraint or additional treatment. The duration of the patient's participation is defined as~     follows: from the date of the preoperative consultation or from the consultation of~     announcement until his / her discharge from hospital. The exclusion period defined in this~     study extends from the date of inclusion of the patient to the date of the surgical~     procedure, during which time the patient can not participate in another clinical research~     protocol.~   "
34747|NCT03111758|"~     Rationale:~      Stent therapy has been proven to be an effective form of therapy in the treatment of chronic~     iliofemoral and iliocaval post-thrombotic obstruction. During the first post-intervention day~     intermittent pneumatic compression stockings (IPCS) are necessary to augment venous flow.~     This will inherently prevent early stent occlusion. Our aim is to investigate whether the~     Geko device is effective as IPCS regarding augmentation of flow in post-thrombotic patients~     during the first day after stenting.~      Objective: The primary objective of this study is to identify whether the Geko system is~     effective in augmenting flow compared to IPCS in post-thrombotic limbs before after stenting.~      Study design: Interventional pilot study with randomized cross-sectional design.~      Study population: Patients with a post-thrombotic obstruction undergoing a percutaneous~     procedure (PTA, stenting).~      Intervention (if applicable): Treatment with intermittent pneumatic compression stockings~     (IPCS) and Geko-device.~      Main study parameters/endpoints: The main endpoint and parameter of this study is~     time-averaged maximum flow velocity (TAMFV), measured by duplex ultrasonography using its~     pulse wave Doppler function.~   "
34748|NCT03111745|"~     Background:~      Some blood and immune disorders can be helped with HSCT. This is allogeneic hematopoietic~     stem cell transplantation. The person who gets the stem cells has their immune system~     suppressed. This is done to help prevent their body from rejecting the transplant. During~     this time, the person is at a high risk to get viral infections. Researchers want to study~     the records of people who had transplants a few years ago. They want to look at how often~     certain viral complications happened.~      Objective:~      To study how often certain viral complications occurred after HSCT and what risks factors~     were involved.~      Eligibility:~      Records will be reviewed. No participants will be contacted.~      Design:~      Researchers will review medical records from the NIH Clinical Center.~      The records will be from people who had HSCT between 2010 and 2015 when they were between 4~     and 85 years old. They already gave consent for their data to be studied.~      Data collected will include:~      Vital statistics like age and sex~      Viral status of the recipient and donor~      Reason for transplant~      Transplant details~      How the immune system recovered after transplant~      If the recipient got graft versus host disease~      Any infections~      Overall survival~   "
34761|NCT03111576|"~     Normal pregnancy is associated with vasodilation and decreased peripheral resistance, which~     is detected as early as 5 weeks' gestation .~      Pre-eclampsia is a multi-system disorder of the second half of pregnancy , which is~     characterized by increased vascular reactivity and peripheral resistance with pathological~     changes that are consistent with impaired blood flow to the affected vascular beds.~     Investigators will evaluate fetal and maternal vascular changes in normotensive and~     pre-eclamptic patients by Ultrasound and Doppler and their impact on prediction of pregnancy~     outcome.~   "
34762|NCT03111563|"~     The aim of the study is to compare the effectiveness of warm saline distension media versus~     room temperature saline distension media on relieving pain in office hysteroscopy .~   "
34749|NCT03111732|"~     Background:~      Biliary tract cancers are rare but they are serious. Researchers want to see if a certain~     drug helps the immune system fight cancer cells. The drug is called pembrolizumab. It may~     work even better with two chemotherapy drugs that are widely used to treat gastrointestinal~     cancers.~      Objective:~      To study if pembrolizumab given with capecitabine and oxaliplatin (CAPOX) increases the time~     it takes for a person's biliary tract cancer to get worse.~      Eligibility:~      People age 18 and older with previously treated biliary tract cancer that has spread to other~     parts of the body~      Design:~      Participants will be screened with tests as part of their regular cancer care.~      Each study cycle is 3 weeks.~      For 6 cycles, participants will:~      Get pembrolizumab and oxaliplatin on day 1 of each cycle. They will be given in an~     intravenous (IV) catheter.~      Take capecitabine by mouth for 2 weeks then have 1 week without it.~      Participants will complete a patient diary.~      Starting with cycle 7, participants will get only pembrolizumab. They will get it once every~     3 weeks.~      On day 1 of every cycle, participants will have:~      Physical exam~      Review of symptoms and how well they do normal activities~      Blood tests~      Every 9 weeks, they will have a scan.~      Participants may have tumor samples taken.~      Participants will have a final visit about 1 month after they stop the study drug. After~     that, they will be contacted by phone or email yearly.~   "
34750|NCT03111719|"~     This study is focused on measuring mitochondrial activity of human brown adipose tissue.~     During surgery, adipose tissue biopsies from white and brown adipose tissue will be collected~     from the deep neck area. These biopsies will be used to examine mitochondrial function via~     histological analysis, biochemical analysis and in vitro experiments based on precursor cells~     present in the biopsies.~   "
34751|NCT03111706|"~     Prospective observational study conducted on women with previous 1 or 2 CS candidate for~     elective CS. Ultrasonographic evaluation of lower uterine segment using 2D and 3D~     transabdominal and transvaginal then correlated to scar integrity assessed intraoperatively~   "
34752|NCT03111693|"~     Obesity is a chronic metabolic disorder : it leads to coronary heart disease and early~     atherosclerosis.~      Coronary artery calcium measured by CT is known as a robust predictor to predict risk for~     cardiac events in symptomatic and asymptomatic individuals. Furthermore, recent studies show~     that other CT risk factor exists, independent of calcium scoring, such as epicardial fat,~     intrathoracic fat and visceral fat.~      The aim of this prospective study is to evaluate these new cardiovascular risk markers in~     obese patients, using standard dose CT and low dose CT with adaptative statistical iterative~     reconstruction.~   "
34753|NCT03111680|"~     This is a cluster randomized study of an environmental level intervention to improve~     nutrition and physical activity, among public housing residents. Followup was one year post~     baseline~   "
34754|NCT03111667|"~     A hybrid effectiveness-implementation trial that is designed to assess the effectiveness of~     an intervention (The Teen Marijuana Check-Up) when delivered in real world settings. In~     addition, the study will assess the frequency of coaching support needed by providers to~     maintain adherent skill levels.~   "
34755|NCT03111654|"~     Atrial fibrillation (AF) is a frequent heart rhythm disorder, responsible for the formation~     of cardiac thrombi, which can embolize in the systemic circulation, responsible for strokes~     (Cerebrovascular accidents). AF increases the risk of stroke and stroke-related disability.~     Preventing the thromboembolic risk associated with FMD is therefore a public health issue.~     The reference treatment is oral anticoagulation but this treatment is contraindicated in~     patients with a history of intracranial hemorrhage. The percutaneous closure of the auricle~     is a recent technique which makes it possible to exclude this appendix from the left atrium~     where the majority of thrombi are formed in the framework of the AF. Comparative studies have~     shown the effectiveness of this technique, appearing to be similar to that of~     anticoagulation. However, in view of the per-procedural risk, the indication of closure was~     retained by the health authorities only in the event of a contraindication to oral~     anticoagulants in patients with non-valvular AF with a high thromboembolic risk. Patients~     with a history of intracranial hemorrhage are therefore candidates for this technique, but~     there are few studies where these patients were included. The risk-benefit must be~     demonstrated over the long term, in terms of ischemic, hemorrhagic recurrence and becoming~     functional and cognitive.~   "
34756|NCT03111641|"~     Accurate pre-operative lung assessment is important to decide the most appropriate anesthesia~     plan. Until now, chest X-ray is considered the standard of care for lung assessment during~     perioperative evaluation. However, lung ultrasound is a rapid, simple, non-invasive,~     radiation-free imaging modality and can be used as an alternative to chest radiography for~     the diagnosis and follow-up of various lung diseases. Moreover, the decreased radiation~     exposure represents a considerable improvement in patient safety. Consequently, we decided to~     compare the data obtained from the lung ultrasound and the chest X-ray.~   "
34757|NCT03111628|"~     This is a Phase IV, single-site study that will examine blood cells or tissue obtained from~     CIU patients receiving open-label treatment with omalizumab at the current FDA-approved dose~     of 300 mg/month for 12 weeks in addition to standard therapy with anti-histamines. Results~     from the 3 Phase III studies in CIU patients provide evidence that a meaningful change in~     symptoms is apparent at 1-2 wks. The Minimal Important Difference (MID) is achieved by 70% of~     patients by 2 wks on multiple background drugs for hives. The goal is to identity the IgE~     bearing cell type associated with clinical symptom change.~   "
34758|NCT03111615|"~     Breast Cancer is a public health issue worldwide. The time from diagnosis to treatment~     initiation varies from country to country and regionally within a country. Early diagnosis~     and prompt treatment initiation are key factors in patient survival rates.~      Currently there is a rising trend, with a high percentage of patients with Luminal like~     breast cancer only undergoing adjuvant endocrine therapy.~      Authors argue that tumor biology alterations after introducing very early endocrine therapy~     might have a prognostic and therapeutic impact and should be studied.~   "
34763|NCT03111537|"~     Cigarette smokers will be randomized to E-cigarette, Nicotine Gum or Lozenge, or Control~     Group. Participants will enter a 1 week sampling phase. Smokers interested in continuing with~     the study after the sampling phase will undergo a 2 week baseline assessment phase and will~     then enter an 8 week intervention. Tobacco use patterns, subjective responses to product, and~     nicotine and toxicant exposure will be assessed.~   "
34764|NCT03111524|"~     Children who stutter (CWS) are at high risk of being teased and bullied in primary school~     because of the negative peer attitudes and perceptions towards stuttering. Their experiences~     can lead to long-term negative psychosocial consequences which can in turn affect academic~     performance. There is little evidence to determine if classroom-based interventions are~     effective in changing peer attitudes to stuttering. This study is designed to assess whether~     a classroom-based CCR intervention versus usual practice in schools will lead to positive~     shift in attitudes about stuttering at 6-months among grade 7 students.~   "
34765|NCT03111511|"~     The main purpose of this study is to evaluate the effect of steady-state concentrations of~     JNJ-56136379 on the single-dose pharmacokinetics (PK) of drospirenone and ethinylestradiol~     (oral contraceptive [OC]) in healthy female participants and to evaluate the effect of~     steady-state concentrations of JNJ-56136379 on the single-dose PK of midazolam (sensitive~     probe substrate for CYP3A4) in healthy female participants.~   "
34766|NCT03111498|"~     Training is very important for acquisition and maintenance of obstetric skills. As a~     one-to-one practical teaching needs time and personal resources, the investigators want to~     prove the benefit and necessity of the one-to-one training program compared to a theory-based~     training program in conducting vacuum assisted deliveries (VAD).~      The aim of this study is to prove that a practice-based training program (one-to- one~     teaching) leads to better training results compared to a theory-based training program in~     conducting VAD.~   "
34767|NCT03111485|"~     This trial will assess whether long-acting levodopa taken at night improves obstructive sleep~     apnea (OSA) in patients with Parkinson's disease (PD), as compared with placebo.~   "
34768|NCT03111472|"~     This study will investigate whether it is possible, through the development and evaluation of~     a self-management guide, to improve health related quality of life and concern of falling in~     people with Parkinson's disease who fall, and reduce caregiver burden in their informal~     caregivers.~   "
34769|NCT03111459|"~     The primary objective of the clinical investigation is to assess the use of the Medtronic~     Valiant Thoracoabdominal Stent Graft System to repair thoracoabdominal aortic aneurysms in~     patients having appropriate anatomy. The primary intent of the study is to assess safety and~     preliminary effectiveness of the device. Additionally, the study will assess technical~     success and treatment success at each follow-up interval.~   "
34770|NCT03111446|"~     Anesthesia for caesarian section in patients with HELLP syndrome is a challenge. Measures~     should be taken during caesarian delivery to guard against the maternal and fetal~     complications associated with HELLP syndrome.~   "
34771|NCT03111433|"~     The purpose of this study is to determine wether coenzyme Q10 is effective in reducing~     markers of endothelial dysfunction in pediatric patients with type 1 diabetes mellitus and~     aslo to investigate its effect on glycemic control and lipid profile of those patients and~     its effect on patient's quality of life.~   "
34772|NCT03111420|"~     Study to evaluate the performance of the AggreGuide A-100 ADP assay for detection of platelet~     dysfunction caused by P2Y12 inhibitor antiplatelet therapy.~   "
34773|NCT03111407|"~     The purpose of this prospective study is to evaluate Zimmer® iASSIST™ with respect to~     radiographic, clinical and economic outcomes and compared to conventional instrumentation in~     primary total knee arthroplasty (NexGen or Persona knee implants).~   "
34774|NCT03111394|"~     This is a pilot study looking at the feasibility of a mobile application (app) to collect~     data from active tasks (questionnaires, 6Mapp™, COGapp™, VISapp™), clinical magnetic~     resonance imaging information and conduct genome-wide association studies in subjects with~     multiple sclerosis. Participants will be self-referred to this study from different sources;~     patient advocacy groups, social media tools, clinicaltrials.gov, and flyers.~   "
34775|NCT03111381|"~     Double blinded randomized controlled clinical trial to assess the impact of intraoperative~     Toradol on post-operative pain scores for patients undergoing ureteroscopy for urinary stone~     management.~   "
34776|NCT03111368|"~     50 patients with pancreatic mass will undergo endoscopic ultrasound-guided fine needle~     aspiration using two techniques: negative pressure and slow-pull. Cytological results will be~     compared.~   "
34777|NCT03111355|"~     This study investigates the effect of genetic variations after supplementation with Brazil~     nuts in healthy Brazilians. Briefly, all the participants will consume one nut a day for 2~     months and will stop the intake for more 2 months. Five blood sampling collection will be~     performed in one month interval, starting at baseline and ending at 2 months without~     intervention.~   "
34778|NCT03111342|"~     The primary aim of our study is to evaluate the effect of intracervical anesthesia on pain~     scores immediately following levonorgestrel-releasing intrauterine system (LNG-IUS) insertion~     in nulligravida women.~   "
34779|NCT03111329|"~     The study aims to compare routine assessment of gastric residuals versus no assessment of~     residuals in preterm neonates with respect to time taken for achieving full enteral feeding~     and the incidence of possible complications, such as feeding intolerance, necrotizing~     enterocolitis, sepsis etc.~   "
34780|NCT03111316|"~     In term women presenting for labor induction, combined use of the controlled release~     dinoprostone vaginal insert and Foley catheter for cervical ripening will decrease the median~     time from induction to vaginal delivery by at least four hours compared to the Foley catheter~     alone.~   "
34781|NCT03111303|"~     Hospital-acquired pneumonia (HAP) in patients in intensive care often requires the mechanical~     ventilation (MV). Management and weaning from MV are given by specificity of this type of~     pulmonary inflammation. Enrolled in the retrospective, observational study were all patients~     older than 18 years staying at the ICU of University Hospital in Olomouc, between 1 January~     2011 and 31 December 2016. The determination of the parameters of the MV, ICU length of stay,~     hospital length of stay and mortality in HAP group were compared with the control group of~     patients without HAP.~   "
34843|NCT03110497|"~     The purpose of the study is to evaluate safety and feasibility of single brachytherapy~     application with dose delivery in multiple fractions. Study will be conducted in Phase I/II~     clinical trial setting with strict Image guidance protocol.This study is expected reduce~     treatment duration and to increase ease and acceptability of brachytherapy in patients along~     with significant saving of resources~   "
34844|NCT03110484|"~     Pemetrexed in combination with erlotinib as a salvage treatment in patients with metastatic~     biliary tract cancer (BTC) who failed gemcitabine containing chemotherapy~   "
34782|NCT03111290|"~     Purpose: To investigate whether rhythmic direct electrical stimulation (DES) causes~     entrainment of endogenous neural oscillatory activity and whether such activity improve~     cognition.~      Participants: Drug-resistant epilepsy patients undergoing epilepsy surgery cortical mapping~     with continuous electrocorticography (ECoG) with intracranial electrodes.~      Procedures (methods): Rhythmic electrical stimulation will be delivered via intracranial~     electrodes during routine extra-operative cortical mapping. Long-term ECoG, Pre-stimulation~     ECoG, peri-stimulation ECoG, and post-stimulation ECoG data will be analyzed to assess for~     entrainment of neural oscillations.~   "
34783|NCT03111277|"~     Neuropathic pain is often a result of direct diseases of peripheral or central nervous system~     with an estimated prevalence of 8% of adults and this pain is associated with significant~     consequences because of longer symptom duration and severity than many of the other pain~     syndromes. Functional brain imaging has revealed that many regions of the brain are engaged~     by painful events, but specific areas such as the thalamus have been markedly implicated.~      The purpose of this study is to determine the feasibility and safety of MRI-guided focused~     ultrasound treatment using the ExAblate Transcranial System in patients suffering from~     Neuropathic pain. This treatment modality offers non-invasive precise treatment potential for~     these patients.~   "
34784|NCT03111264|"~     Pediatric obesity, a defining health problem of the century, leads to long-term health~     disparities. This application evaluates strategies to prevent health disparities early in~     life by developing environmental wellness-related interventions focused on child-care center~     staff and families.~      Child-care centers provide an excellent opportunity to build healthy dietary and physical~     activity lifestyle habits and avoid the rapid weight gain that leads to health disparities.~     Building on a statewide survey among child-care centers and a pilot evaluation of an~     environmental intervention, this 3-cell randomized trial evaluates the impact of a~     staff-focused environmental wellness intervention and a staff and family-focused~     intervention, against a control condition.~   "
34785|NCT03111251|"~     The purpose of the study is to determine the comparative effectiveness of a provider-only~     intervention and a parent plus provider intervention to increase initiation of HPV~     vaccination among male and female patients ages 11-17 in a large pediatric clinic network in~     the greater Houston area. The hypothesis is that HPV vaccine initiation will be higher in~     clinics randomized to the parent plus provider intervention compared with clinics randomized~     to the provider-only intervention.~   "
34786|NCT03111238|"~     This trial is a pivotal, placebo-controlled, double-blind, parallel-group, adaptive trial~     conducted in subjects with DM and CLI Rutherford Category 4. Minimisation will be used to~     assign eligible subjects in a 2:1 ratio to receive a single intra-arterial administration of~     Rexmyelocel‑T or matching placebo into the index limb.~   "
34787|NCT03111225|"~     This study examines the prevalence of trigger points in muscles in the thorax in upper limb~     Complex Regional Pain Syndrome (CRPS) patients, compared to healthy subjects. In addition, we~     will examine if adding treatment to muscles in the thoracic area (to the regular physical~     therapy treatment) will alleviate some of the sensitivity in the upper limb in CRPS patients.~   "
34788|NCT03111212|"~     The patients will be randomized into one of two groups. Both groups will receive standard~     care as is state of the art. The intervention group will receive Iloprost nebulized as~     inhalative therapy.~   "
34789|NCT03111199|"~     The purpose of this study is to analyze the effects of TENS Burst combined Cryotherapy on~     painful sensation, functional capacity and quality of life of patients with non-specific~     chronic pain.~      Study hypothesis:~      The TENS Burst combined with Cryotherapy offers a better response in the pain sensation,~     functional capacity and quality of life of patients with non-specific chronic low back pain~     when compared to the application of these resources in isolation.~   "
34790|NCT03111186|"~     This study is about pain control and medication following outpatient soft-tissue hand~     surgery. We hope to learn if ibuprofen and acetaminophen will achieve similar pain relief and~     satisfaction when compared with oxycodone alone.~   "
34791|NCT03111173|"~     This is a feasibility study for a new application for capturing fetal cardiac activity. The~     objective of this study is to determine if it is feasible to capture a fetal ECG signal using~     a Holter ECG device. As comparison we will use a standard Doppler Fetal Heart Rate (FHR)~     device.~   "
34792|NCT03111160|"~     Small-incision lenticule extraction (SMILE), the most recently developed refractive surgical~     technique, is being performed in a growing number of cases. This intrastromal keratomileusis~     using only a femtosecond laser is a new procedure that extracts the refractive lenticule~     through a small corneal incision ranging from 2 to 5 mm, with the absence of a flap and the~     preservation of the anterior-most stromal lamellae and Bowman's layer (except for the region~     of the small incision). Many studies have demonstrated that SMILE achieved comparable or~     superior efficacy, safety, and predictability to femtosecond laser -assisted in situ~     keratomileusis (FS-LASIK) and femtosecond lenticule extraction (FLEx). However, the recovery~     of visual acuity in the early postoperative period after SMILE is slower, compared to other~     refractive surgery techniques. Therefore, adjusting energy might improve postoperative visual~     acuity and recovery time after SMILE. Nevertheless, the optimal parameters drawn from a~     well-organized randomized study have yet to be elucidated. The purpose of this study was to~     investigate the optimal femtosecond laser energy, with the aim of improving clinical outcomes~     during the early postoperative period after SMILE for the correction of myopia. To this end,~     we used a 500 kHz VisuMax with spot-spacing control at energy levels lower than 115 nJ, based~     on the previous studies. Therefore, we prospectively compared visual outcomes of two groups~     randomly divided by different laser energies: one underwent SMILE using lower energy levels~     of 100, 105, and 110 nJ (L-SMILE), while the other group underwent SMILE at energy levels~     conventionally used of 115 to 150 nJ (C-SMILE).~   "
34793|NCT03111147|"~     The proposed study is a prospective, single-blinded, randomized trial to investigate the~     impact of humeral component version on shoulder range of motion and patient reported~     functional outcomes following reverse total shoulder arthroplasty.~   "
34904|NCT03109704|"~     This study evaluates the immediate effects of a supine upper thoracic spine thrust~     manipulation, seated upper thoracic spine thrust manipulation, and sham manipulation for~     individuals with subacromial pain syndrome. The participants were randomized to receive one~     of the three interventions and baseline measures for the dependent variables were repeated~     immediately after the delivery of the intervention.~   "
34794|NCT03111134|"~     At present, open-type abdominal surgery is routine access into the abdomen. Median incision~     is the common choice with open-type abdominal surgery. Layered abdomen-closing is often used~     at the end-time of the surgery. There are some common postoperative complications, such as~     incision pain, surgical site infection, surgical incision dehiscence and incisional hernia.~     The key to reduce the incidence of postoperative complications depends on safe and reliable~     technology of abdomen-closing.~      It's usually difficult to close the abdomen after the incisional hernia surgery, and the~     recurrence of incisional hernia is high. But the recurrence fell off observably when~     component separation technology was applied to abdomen-closing of incisional hernia.~      Based on this, we hypothesis that modified-CST applied to abdomen-closing in routine~     abdominal surgery may improve the quality of wound-healing.~      In this prospective single-blind randomized controlled trial, traditional abdomen-closing~     technology and modified-CST will be used to gastric cancer surgery, and the quality of~     wound-healing will be evaluated to confirm which kind of abdomen-closing technology better.~   "
34795|NCT03111121|"~     Use of Muscle relaxant and reversal with Sugammadex at end of airway procedures will reduce~     the time to extubation after end of procedure~   "
34796|NCT03111108|"~     The purpose of this study was to evaluate the efficacy of each treatment arm using a fixed~     dose combination (FDC) of EBR/GZR as assessed by the percentage of participants achieving~     sustained virologic response, defined as HCV ribonucleic acid (RNA) <Lower Limit of~     Quantitation (LLOQ) 12 weeks after the end of all study therapy (SVR12). This study also~     evaluated the safety and tolerability of EBR/GZR.~   "
34797|NCT03111095|"~     The purpose of this study is to see if Honeywell Genesis Android Touch Bluetooth System~     (mobile health) can improve patient satisfaction and quality of care provided to women~     experiencing complications due to high blood pressure during pregnancy.~   "
34798|NCT03111082|"~     This prospective, observational study will assess 100 subjects in the post-anesthesia care~     unit (PACU) at Parkland Hospital. Upon arrival to the PACU, patients' train-of-four (TOF)~     ratio will be calculated using the StimPod NMS450 accelerometer to determine the presence of~     any residual paralysis. Any patient with a TOF ratio < 0.9 will be reassessed every 10~     minutes until the ratio is ≥0.90. The time it takes to reach a TOF ratio ≥0.9 will be~     recorded. Subjects will be classified according to BMI categories: lean as <30 kg/m2, obese~     as 30≤BMI≤39.9 kg/m2, and morbidly obese as BMI ≥40 kg/m2. This data will serve as a baseline~     to assess the incidence of residual NMB that currently occurs in our PACU so that we may use~     this pilot data to design future studies that aim to reduce the incidence of residual NMB.~   "
34799|NCT03111069|"~     The goal of this clinical research study is to find the highest tolerable dose of heated~     doxorubicin that can be given to patients during surgery with abdominal tumors. The safety of~     this drug will also be studied.~   "
34800|NCT03111056|"~     The goal of this study is to empirically evaluate a web-based intervention to reduce heavy~     drinking among college women with a history of sexual assault who display elevated levels of~     psychological distress. College women with a history of sexual assault often report more~     heavy drinking and psychological distress than women without a history of assault. Moreover,~     women with assault histories often have difficulty regulating their emotions and tolerating~     distress which can lead to a pattern of drinking to cope distress. Trauma exposure, negative~     mood, and poor coping strategies have been associated with poor treatment outcomes and~     relapse following alcohol treatment. Incorporating distress tolerance and emotion regulation~     skills with an alcohol intervention may enhance treatment effects among women with a history~     of sexual assault by decreasing their motivation to drink to cope with depression or anxiety~     and by building adaptive coping strategies. Therefore, the web-based intervention will~     include cognitive behavioral skills for reducing alcohol consumption and incorporate emotion~     regulation and distress tolerance skills from Dialectical Behavior Therapy.~   "
34801|NCT03111043|"~     Out-of-hospital arrest can occur from multiple etiologies. In patients without an obvious~     reason for the sudden-death event, diagnostic evaluation is not clear. This study is to~     determine if early imaging with a head-to-pelvis CT scan may improve diagnostic accuracy,~     speed of diagnosis and potentially clinical outcomes.~   "
34802|NCT03111030|"~     This study will employ a randomized, wait-list controlled trial. A total of 30 participants~     (15 experimental, 15 wait-list control) between 18-65 years of age who have chronic SCI ≥ 1~     year prior will be recruited. Physical activity measures will be taken using wrist-based~     accelerometers and the Leisure Time Physical Activity Questionnaire for people with SCI~     (LTPAQ). Psychosocial factors will be evaluated through questionnaires. The primary health~     outcome measure (aPWV), and secondary cardiovascular parameters will be assessed using a~     combination of echocardiography and ultrasound. Fitness will be determined using a peak~     oxygen consumption test on an arm-cycle ergometer. All measurement will be taken at baseline~     and after 9 weeks following intervention commencement. Physical activity will also be sampled~     mid-intervention at 4 and 7 weeks. Training will involve weekly, 10-15 minute coaching~     sessions for 9 weeks. All pre- and post-assessments will take place at the Blusson Spinal~     Cord Centre at ICORD. Intervention content will be delivered in-person, over Skype or phone,~     and the wrist- worn accelerometers will be delivered and picked up from the participant's~     home during the intervention.~   "
34803|NCT03111017|"~     Heart failure with preserved ejection fraction (HFpEF) is the fastest growing form of heart~     failure with a high morbidity and mortality rate, and is associated with severe exercise~     intolerance. The mechanisms responsible for the reduced exercise tolerance remain poorly~     understood. The investigators propose a novel paradigm shift, focusing on peripheral~     limitations to exercise. In particular, the investigators will test the hypothesis that~     muscle sympathetic nerve activity (MSNA) is elevated in older HFpEF patients compared to~     healthy controls, and is associated with reduced exercise tolerance. The investigators will~     also test whether 16-weeks of exercise training will lower MSNA compared to attention~     control, and correlate with improved exercise tolerance in older HFpEF patients.~   "
34804|NCT03111004|"~     The study evaluates the impact of the new organisational models developed in the framework of~     the BeyondSilos pilot service in order to provide ICT supported integrated health and social~     care to elderly patients~   "
34905|NCT03109691|"~     Ultrasound Guided Bilateral Superficial Cervical Block for Postoperative Pain Therapy in~     Thyroid Surgery~   "
34805|NCT03110991|"~     Major depression is a common disorder among non-professional caregivers, and it can be~     disabling and costly. Although there are effective psychological interventions to prevent~     depression, most of them involve in-person treatment. New technologies have the potential to~     overcome the barriers this format presents, which limit accessibility to such interventions.~     The main objective of this project is to evaluate the effectiveness of a cognitive-behavioral~     intervention in the prevention of depression, administered through a smartphone application~     (App), both with and without telephone contact through multiconferencing. Secondary~     objectives are: (a) test the moderating or mediating effect of the variables in the~     theoretical model underlying the intervention; (b) analyze the variables that are predictors~     of intervention outcomes; (c) analyze the acceptability and satisfaction with interventions.~     A randomized controlled trial will be perform. Caregivers with clinically significant~     depressive symptoms who do not meet the diagnostic criteria for depressive episode will be~     included. Recruitment of 174 participants is planned, with random allocation to one of the~     three conditions (58 participants per intervention): (a) a cognitive-behavioral intervention~     administered via a smartphone App (CCIA); (b) a cognitive-behavioral intervention~     administered via a smartphone App + telephone contact via conference call (CCIA+CC); (c)~     attention control group (ACG). Both interventions will be administered in 5 modules via an~     App for Smartphones and one group additionally will receive telephone contact via conference~     call in group format during 4 sessions of 30 minutes. These phone sessions will be recorded~     to assess the therapists adherence to the intervention protocols. All participants will be~     evaluated at pre and posttreatment, and 1-, 3-, 6- and 12-month follow-up by trained~     interviewers who will be blind to the aims of the study, the interventions employed, and the~     group to which any given participant belongs. Incidence of depression will be examined as the~     primary measure, with secondary measures being depressive symptoms, symptoms related to the~     model (pleasant activities, negative thoughts and social contacts) and the acceptability of~     and satisfaction with the intervention.~   "
34806|NCT03110978|"~     The goal of this clinical research study is to learn if adding nivolumab to standard~     treatment (stereotactic ablative radiotherapy [SABR]) can help to control recurrent (has come~     back) non-small cell lung cancer (NSCLC).~      This is an investigational study. SABR is delivered using FDA approved and commercially~     available methods. Nivolumab is FDA approved and commercially available for the treatment of~     NSCLC. It is considered investigational to use it in combination with SABR to treat NSCLC.~      Up to 140 participants will be take part in this study. All will be enrolled at MD Anderson.~   "
34807|NCT03110965|"~     The effect of two isometric exercises is measured on Cobb angles from films taken 4-10 months~     apart.~   "
34808|NCT03110952|"~     The potential synergistic effect of administering 2 dengue vaccine candidates that were~     previously shown to be safe and immunogenic in humans will be evaluated in this study. A~     prime-boost study of tetravalent dengue virus purified inactivated vaccine (TDENV-PIV) with~     the GSK AS03B adjuvant and tetravalent dengue live attenuated virus (TDENV-LAV) vaccine~     Formulation 17 (F17) will gather data to help better understand the human immune response to~     dengue vaccination and infection.~      This study is being done to evaluate the safety and immune reaction of administering one dose~     of dengue purified inactivated vaccine and one dose of dengue live attenuated vaccine~     compared to two doses of inactivated vaccine.~   "
34809|NCT03110939|"~     The goal of this clinical research study is to explore whether intrathoracic hyperthermic~     perfusion after radical surgery could reduce local recurrence rate(13%) for advanced lung~     cancer / esophageal cancer. The safety of intrathoracic hyperthermic perfusion right after~     surgery.~   "
34810|NCT03110926|"~     Evaluate mFOLFOX6 (5-Fluorouracil, Leucovorin and Oxaliplatin) chemotherapy as induction~     treatment prior to standard neoadjuvant chemoradiation to decrease the rate of distant~     recurrence among patients with locally advanced esophageal cancer.~   "
34811|NCT03110913|"~     The research study is being done so we can determine the quality of the protein present in~     Canadian lentils. Amino acids are the building blocks of protein and protein quality is~     determined by the amount of amino acids present and by their bioavailability (their~     absorption and use by the body). Some amino acids are essential which means they must be~     obtained from the diet. If any one of the essential amino acids is missing in the diet, the~     body cannot make proteins that are used to repair tissue build bone, teeth, etc… Lentils as a~     food source contain low amounts of the essential amino acid methionine which makes its~     protein incomplete. The amino acids in lentils are also affected by cooking. Our objective is~     to determine the amount of methionine in lentils that the body can use. We will test lentils~     by studying them after cooking them in a stew, on their own and by combining the lentil stew~     with rice in a mixed meal to make a more complete protein.~      This research is being done in order to bridge the gap between knowledge of protein~     requirement and the amount of food needed to meet that requirement. Results from this study~     will be important for recommendations guiding food choices of lentils as a major protein~     source in the diet.~      Previously the quality of dietary protein for human consumption was studied in animals. This~     study is being done in humans because studies in animals are not directly applicable to~     humans. Excessive animal protein consumption is also linked to cardiovascular disease. Plant~     protein sources like lentils are important alternatives shown to enhance ecosystem~     resilience, and improve human health.~   "
34812|NCT03110900|"~     The primary objective of this study is to determine the noninferiority of inhaled loxapine~     compared to intramuscular haloperidol/lorazepam on agitation reduction at 120 minutes.~   "
34813|NCT03110887|"~     Rationale: Approximately 10% of neonates admitted to neonatal intensive care units develop a~     major hemorrhage. In an attempt to avert this severe complication various preventive measures~     have been implemented. One of these is the transfusion of platelets to premature neonates~     with low platelet counts. However, this practice is not supported by scientific evidence.~     Most neonates with low platelet counts never experience a major bleeding and platelet~     transfusions may carry risks of volume overload or infection. Therefore, it is important to~     treat only those patients that truly benefit from this intervention. We urgently need a~     scientifically based tool to predict which premature neonates are at risk for major bleeding.~     A few prediction models do exist, but these only allow assessment of bleeding risk at~     baseline, and do not correct for changes in clinical status during the admission period. We~     believe that adding this feature to our prediction model will significantly improve our~     ability to predict bleeding. The prediction model will also be helpful in developing~     individualized transfusion guidelines as it helps us to predict which neonates would benefit~     from prophylactic platelet transfusions.~      Main objective: to develop a dynamic prediction model for bleeding in preterm neonates with~     low platelet counts.~      Study design: retrospective observational cohort study.~      Study population: neonates with a gestational age at birth of < 34 weeks admitted to a~     neonatal intensive care unit (NICU), with a thrombocyte count of less than 50x109/L will be~     included.~      Assessments: only data generated through standard care will be collected. This includes~     platelet counts, cerebral ultrasounds, information about bleeding and transfusions, and~     multiple clinical variables.~      Main study endpoint: major bleeding during admission~      Statistical analyses: dynamic prediction model using landmarking.~   "
34814|NCT03110874|"~     A multi-center, randomized, open, non-inferiority, Phase 4 study~   "
34815|NCT03110861|"~     The purpose of this study is to evaluate the safety and effectiveness of the TPV in patients~     with pulmonary valve dysfunction.~   "
34906|NCT03109678|"~     The intubating laryngeal mask Fastrach™ is considered a gold standard for blind intubation as~     well as for fibreoptic guided intubation via a laryngeal mask. Recently, a single use version~     of the mask has been introduced. The Fastrach single use laryngeal mask is beng compared to~     the new, low-priced single use intubating laryngeal mask Ambu Aura-i™.~   "
34816|NCT03110848|"~     Graves' orbitopathy (GO) is the most common extra-thyroidal manifestation of Graves' disease~     (GD), being observed in ~25% of patients. Besides genetic and demographical variables, risk~     factors associated with the development of GO in GD patients are known to be inadequate~     control of hyperthyroidism, radioiodine treatment, and smoking. In a large retrospective~     study conducted in more than 8,000 individuals with GD it was observed that treatment with~     3-hydroxy-3-methylglutaryl-coenzyme reductase inhibitors, better known as statins, is~     associated with a ~40% reduced risk of developing GO in GD patients. The findings were~     interpreted as the consequence of the anti-inflammatory action of statins, being GO~     notoriously an autoimmune, inflammatory conditions.~      Statins are widely used for the treatment of hypercholesterolemia, for which they are quite~     effective. The possibility that their protective effect in terms of GO development in GD~     patients, as observed by Stein et al., was simply due to their hypolipemic actions was not~     considered. To evaluate the possibility that the findings reflected lowering of cholesterol~     rather than a direct anti-inflammatory effect of statins a prospective, observational study~     to assess the association between GO and high cholesterol levels and/or the relationship~     between the degree and/or activity of GO and hypercholesterolemia is ongoing. Preliminary~     findings suggest that GO is more severe and active in patients with high cholesterol levels.~     On the basis of these observations, the present randomized clinical trial was designed to be~     performed in hypercholesterolemic patients with GD and moderate-to-severe and active GO,~     aimed at investigating if lowering of cholesterol levels with statins is associated with a~     better outcome of GO.~   "
34817|NCT03110835|"~     Graves' orbitopathy (GO) is an autoimmune condition almost always associated with autoimmune~     thyroid disease, especially Graves' disease (GD). According to the most widely accepted~     model, the autoantigen/s responsible for GO would include molecules expressed by thyroid~     epithelial cells that are present also in orbital tissues. The high likelihood that the~     etiologies of GO and of the underlying autoimmune thyroid diseases are somehow linked is~     confirmed by the very close relationship between GO, the onset and the course of Graves'~     diseases, the size of the thyroid gland, and most importantly, thyroid function and thyroid~     treatment. Based on these considerations, it has been proposed that complete removal of~     thyroid antigens and of thyroid infiltrating lymphocytes, the so called total thyroid~     ablation (TTA), may be followed by an attenuation of the immune reaction against orbital~     antigens, and ultimately by an amelioration of GO. The possibility that TTA, achieved by near~     total thyroidectomy followed by radioiodine, may be beneficial for GO was initially suggested~     by two retrospective studies and more recently by two prospective, randomized clinical trials~     conducted in patients with moderate GO treated with intravenous glucocorticoids. Although~     there seemed to be no difference in the long term, compared with near total thyroidectomy~     alone TTA was associated with a shorter time required for GO to improve, or anyway to reach~     its best possible outcome, and with a lesser requirement for additional treatments in order~     for GO to improve.~      TTA is usually performed with a radioiodine dose of 30 millicurie (mCi), administered after 2~     injections of recombinant human thyrotropin TSH (rhTSH), the latter in order to induce~     radioiodine uptake by thyroid remnants. According to the Italian legislation the~     administration of such a dose of radioiodine must be followed by a 24 hours protected~     hospitalization. Clearly, this necessity implies a remarkable increase of the waiting list,~     due to the limited number of radiation-isolated beds available and, concerning GO patients,~     to the competition with patients with thyroid cancer. In contrast, a radioiodine dose of 15~     mCi can be performed in out-patients without hospitalization and with much lower costs.~     Concerning GD patients, they usually have serum TSH-receptor stimulating antibodies that ay~     persist after thyroidectomy and that may increase radioiodine uptake along with rhTSH,~     possibly resulting in the need for a lower dose of radioiodine to ablate thyroid remnants. In~     order to investigate whether this is the case, the present study was designed in patients~     with GD. The study design was to include patients scheduled to radioiodine treatment with 30~     or 15 mCi after administration of rhTSH, being the primary outcome the values of serum~     thyroglobulin at peak after administration of rhTSH 6 months after radioiodine, as a measure~     of the presence of residual thyroid tissue.~   "
34818|NCT03110822|"~     This is a phase 1, multicenter, open-label study evaluating the safety and efficacy of~     ruxolitinib, steroids and lenalidomide among MM patients who currently show progressive~     disease.~   "
34819|NCT03110809|"~     This research study is being done to determine whether taking a dietary supplement called~     capsinoids, derived from sweet peppers, can activate brown fat that is already present or~     even generate new brown fat in individuals with excess weight. Previous studies have~     suggested that chronic consumption of capsinoids may be able to generate new brown fat in~     thin individuals. Capsinoids may also have a small positive effect on metabolism (increased~     calorie-burning) and fat loss. The knowledge gained in this study may eventually lead to more~     treatment options for people with excess weight.~   "
34820|NCT03110796|"~     Evaluation of the efficacy and safety of a device with LU3103209 compound versus the same~     device, free of LU3103209 compound, in the local management of DFUs.~   "
34821|NCT03110783|"~     A Prospective, Randomized, Controlled, Single Blinded, Study to Evaluate the Safety and~     Effectiveness of Bioseal as an Adjunct to Sutured Dural Repair~   "
34822|NCT03110770|"~     This is a multicenter, randomized, study to evaluate the safety, immunogenicity, and efficacy~     of VRC-ZKADNA090-00-VP (Zika virus wildtype DNA vaccine) or placebo. In Part A, the primary~     objective is to evaluate the safety and tolerability of the vaccine. In Part B, the primary~     objectives are to evaluate the safety and efficacy of the vaccine compared to placebo.~   "
34823|NCT03110757|"~     The study will be conducted as a randomized, controlled, double blind Phase 1b~     dose-escalating clinical trial in up to 60 healthy adult males and non-pregnant females~     living in the S. mansoni-endemic area of Americaninhas, Brazil. The primary objective of this~     trial is to assess the safety and reactogenicity of ascending doses of Sm-TSP-2/Alhydrogel®~     (10mcg, 30mcg, or 100mcg) vaccine with or without AP 10-701 given as three doses administered~     on Days 1, 57, and 113.~   "
34824|NCT03110744|"~     In chordoma cell lines and patient biopsies, the p16 (CDKN2A) tumor suppressor is~     consistently deleted. Thus, chordomas are an example of a tumor with universal activation of~     the cyclin-dependent kinases 4 and 6 (CDK4/6) pathway, and experiments with patient-derived~     chordoma cell lines demonstrate aberrant CDK4/6 activity downstream of p16 loss can be~     efficiently inhibited by the CDK4/6 inhibitor palbociclib, resulting in reduced proliferation~     and growth of neoplastic cells. The investigators aim to conduct a phase II clinical trial to~     evaluate the efficacy of the small-molecule CDK4/6 inhibitor palbociclib in patients with~     locally advanced/metastatic chordoma who are not candidates for standard therapy. The primary~     objective is disease control in patients with chordoma treated with palbociclib as single~     agent. The study design of this phase II study is based on a Simon two-stage design.~   "
34856|NCT03110328|"~     eligible subjects will receive treatment beginning on Day 1 of each 3-week dosing cycle for~     pembrolizumab. Treatment with pembrolizumab will continue until documented disease~     progression, unacceptable adverse event(s),intercurrent illness that prevents further~     administration of treatment, Investigator's decision to withdraw the subject, subject~     withdraws consent, pregnancy of the subject, noncompliance with trial treatment or procedure~     requirements, subject receives 24 months of pembrolizumab, or administrative reasons~     requiring cessation of treatment.~   "
34825|NCT03110731|"~     The aim of this study was to analyze the effects of strength training on sleep quality and~     daytime sleepiness in institutionalized adolescents (14 to 19 years of age). Thirty-one~     adolescents were randomly assigned in two sample groups: intervention group (IG, n = 19) and~     control group (CG, n = 12). Anthropometric measures were performed (height and body mass) and~     BMI was determined. Sleep quality and daytime sleepiness were assessed using the~     questionnaires, Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESE), and~     total sleep time by accelerometer. Physical training (2x / week) was performed for 12 weeks.~     The OMNI Perceived Exertion Scale for Resistance Exercise (OMNI-RES) scale was used to~     control the effort intensity and the exercises followed an alternate pre-follow-up.~   "
34826|NCT03110718|"~     Muscle vibration (MV) has been suggested as a useful non-pharmacological approach to control~     spasticity. Armeo Power® (AP) is a robotic exoskeleton for rehabilitation allowing early~     rehabilitation treatment. The objective of our study was to determine whether AP training~     coupled with MV applied on antagonist muscles of the spastic upper limb (UL) can reduce the~     spasticity of agonist muscles. We enrolled 20 chronic post-stroke patients, who underwent 40~     daily sessions of AP training. Ten subjects (group-A) received muscle MV (on triceps brachii,~     deltoid, and supraspinatus), whereas the other 10 (group-B) underwent a sham vibration.~   "
34827|NCT03110705|"~     Within the components of Scuba diving there are similarities with meditation and mindfulness~     techniques. Perceived stress is known to be diminished during meditation practice. This study~     evaluates the benefits of scuba diving on perceived stress and mindful functioning.~   "
34828|NCT03110692|"~     The goal of this study is to reduce preference sensitive, unnecessary daily imaging during~     radiation treatment in which a pre-planned quality improvement default option for radiation~     treatment prescriptions will be introduced throughout the network of Penn Radiation Oncology.~   "
34829|NCT03110679|"~     OA-bi-Blind is a randomized double-blind study on the treatment of osteoarthritis of the~     Bilateral knee: autologous bone marrow concentrate vs. hyaluronic acid.~   "
34830|NCT03110666|"~     This pilot study will evaluate the clinica! and radiological results of a treatment for knee~     osteoarthritis with injections of autologous concentrated bone marrow aspirate at the~     bone-cartilage interface via percutaneous.~   "
34831|NCT03110653|"~     Modern anesthesia has made a lot of progress, however, postoperative pain remains one of the~     major problems associated with patient discomfort, prolonged hospital stay and increased~     health care costs.~      Remifentanil is an ultra-short-acting phenylpiperidine opioid analgesic with high lipid~     solubility and a rapid onset of effect.~      Recently, opioid use has also been associated with postoperative opioid-induced hyperalgesia~     or acute opioid tolerance. An immediate discontinuation of remifentanil has been associated~     to increased postoperative pain levels.~      We would like to investigate whether a gradual post-operative withdrawal of remifentanil is~     indeed associated with less immediate pain compared to after an abrupt withdrawal in surgical~     patients undergoing minor surgery.~   "
34832|NCT03110640|"~     This is a single-arm open-label phase I study to determine the effect of CD19- CAR-T Cells~     infusion followed by allogeneic stem cell transplantation in safety, efficacy and engraftment~     potential in patients with CD19+ B-lineage leukemia and lymphoma.~   "
34833|NCT03110627|"~     This study aims to compare the Dx-ICD system (experimental) to standard VVI-ICD (control) on~     the ability to diagnose silent AF in patients without prior AF receiving an ICD for standard~     indications.~   "
34834|NCT03110614|"~     This is a prospective study to determine the relationships between pauci-inflammatory~     exacerbations and diastolic dysfunction, and their implications in hospitalized patients with~     acute exacerbations of COPD. To assess changes within subjects from stable to acute phase, a~     number of comparisons will be made in subjects enrolled during acute exacerbation with~     similar measurements made in the stable phase after recovery from exacerbation after at least~     35 days from index hospitalization or prior exacerbation.~   "
34835|NCT03110601|"~     Trialing of PM modulation therapy in patients with chronic intractable low back pain~   "
34836|NCT03110588|"~     This trial is being conducted to determine the feasibility and recommended dose of the~     combination of four drugs (prednisone, abiraterone, cabazitaxel and enzalutamide (PACE) as~     first-line therapy for metastatic castration-resistant prostate cancer (mCRPC).~   "
34837|NCT03110575|"~     This is an open-label, extension trial designed to evaluate safety over 12 additional weeks~     of TNX-102 SL therapy taken daily at bedtime for the treatment of PTSD. Patients recruited~     into this trial are those who have successfully completed the double-blind lead-in study.~   "
34838|NCT03110562|"~     This Phase 3, 2-arm, randomized, active comparator-controlled, open-label, multicenter study~     will compare the efficacy and health-related quality of life (HR-QoL) and assess the safety~     of selinexor plus bortezomib (Velcade®) plus low-dose dexamethasone (SVd) versus bortezomib~     plus low-dose dexamethasone (Vd) in adult patients with RRMM who have received 1 to 3 prior~     anti-multiple myeloma (MM) regimens. Crossover from the Vd Arm to a treatment that includes~     selinexor (i.e., SVdX or SdX) will be allowed at the point of IRC-confirmed objective disease~     progression per the IMWG criteria for patients in the Vd Arm.~   "
34839|NCT03110549|"~     The study is a Phase 1, randomized, double-blinded, placebo-controlled, sequential single~     dose escalation safety, tolerability and pharmacokinetic study of subcutaneous and~     intramuscular TMB-607 administered to HIV-negative volunteers.~   "
34840|NCT03110536|"~     Assessment of burnout syndrome of triage nurses from Emergency Departments from Cluj-Napoca,~     Romania.~   "
34841|NCT03110523|"~     This is a Phase 3, Multicenter, Randomized, 20 Week, Double-Blind, Placebo Controlled and~     32-Week, Open-Label Study to Evaluate the Efficacy and Safety of X0002 Spray in relief of the~     signs and symptoms of Subjects with Osteoarthritis of the Lumbar Spine. To evaluate the~     efficacy of X0002 spray compared to placebo for the relief of low back pain disability in~     subjects with osteoarthritis (OA) of the low back.~   "
34842|NCT03110510|"~     FOLFIRI as a salvage treatment in metastatic biliary tract cancer (BTC) patients who failed~     gemcitabine containing chemotherapy~   "
34990|NCT03108586|"~     This study will evaluate the effect of the International Dental Federation (FDI) criteria,~     compared to CARS (Caries Associated with Restorations or Sealants) detection criteria for~     evaluation of caries lesions around restorations in permanent teeth, in the outcomes related~     to oral health of adults, in a randomized clinical trial.~   "
34845|NCT03110471|"~     Lay Summary:~      The investigators have shown in randomised controlled trials and observation studies that~     structured nurse-led medicines' monitoring using the WWADR Profile benefits patients, for~     example, by reducing pain and sedation and identifying high risk cardiovascular conditions.~     The investigators now aim to understand what is needed to sustain implementation of the WWADR~     Profile in routine practice and explore future directions.~      The participants of the investigators previous research, 5 newly recruited care homes, and~     stakeholders - care home managers, carers, healthcare professionals, and service users - will~     be asked to contribute interviews, observations and reflective diaries/ accounts. The~     investigators are interested in their experiences of medication use, medication management,~     adverse effects and barriers and facilitators of medicine monitoring, and how electronic~     devices can enhance nurse-led monitoring.~   "
34846|NCT03110458|"~     A multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and~     safety of 2 dose-regimens of orally administered SENS-111 (100mg and 200mg) given during 4~     days in patients suffering from Acute Unilateral Vestibulopathy (AUV)~   "
34847|NCT03110445|"~     Monocentric open-label phase I/II trial aiming at evaluating, in adjuvant setting, safety~     (primary outcome), immunological and clinical efficacy (secondary outcomes) of a non~     replicating recombinant vaccinia virus expressing cancer/testis antigen (CTA) derived~     epitopes and CD80 and CD40 ligand (CD40L, CD154) costimulatory molecules in patients with CTA~     expressing tumors.~   "
34848|NCT03110432|"~     This is a prospective German registry for patients with dyslipidemia with very high~     cardiovascular risk who principally meet the Gemeinsamer Bundesausschuss (G-BA) stipulations~     for Proprotein convertase subtilisin/kexin like type 9 inhibitor (PCSK9i) use, and are~     treated by office-based cardiologists or in lipid ambulances.~   "
34849|NCT03110419|"~     This study aim to evaluate the effects of 16 weeks of multicomponent training on postural~     control, cardiovascular and musculoskeletal systems in pre-frail elderly through nonlinear~     and linear measurements.~   "
34850|NCT03110406|"~     Introduction: Renal transplantation represents the therapeutic mode with more durable~     treatment, greater cost-effectiveness, survival benefits and quality of life of the patients,~     however, with high cardiovascular mortality.~      Objectives: To evaluate the acute and chronic effects on heart rate variability and the~     impact of chronic kidney disease on cardiorespiratory fitness in renal transplant recipients~     following a full-body Vibration training program.~      Methods: It will be a blinded randomized clinical trial (patient, evaluator and~     statistician), controlled and endowed with secrecy of allocation, to be performed in the~     Cardiopulmonary Physiotherapy Laboratory of the Physiotherapy Department of the Federal~     University of Pernambuco. Renal transplant recipients will be recruited at the Nephrology~     outpatient clinic of the Hospital das Clínicas de Pernambuco, according to the following~     inclusion criteria: age between 18 and 59 years, who underwent transplantation at least one~     year before and present a stable transplant function through the level Of creatinine~   "
34851|NCT03110393|"~     The aim of this study is the randomized comparison of two laryngeal mask (Intersurgical~     i-gel® and Ambu®AuraGain™) in obese patients~   "
34852|NCT03110380|"~     The primary objective of this study is to evaluate the efficacy of switching from a regimen~     of either dolutegravir (DTG) and emtricitabine (Emtriva®)/tenofovir alafenamide (Descovy®;~     F/TAF) or DTG and emtricitabine/tenofovir disoproxil fumarate (Truvada®; F/TDF) to a fixed~     dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy®;~     B/F/TAF) versus DTG+F/TAF in virologically suppressed HIV-1 infected adults with or without~     antiretroviral (ARV) resistance as determined by the proportion of participants with human~     immunodeficiency virus-1 ribonucleic acid (HIV-1 RNA) ≥ 50 copies/mL at Week 48~   "
34853|NCT03110367|"~     Pain is a common experience in youth and influences youth long after the painful situations~     are over. Youth memory of pain after surgery can affect painful experiences in the future.~     Negative memories and feelings of pain, like remembering more pain than the actual level of~     pain experienced are linked to anxiety for future surgery. Research has found that children's~     memories of pain is linked to anxiety, pain-related fear, and confidence. Children's memories~     for pain can be altered after a visit to the hospital, but only a couple of studies have look~     at this.~      The study will be one of the first to look at how well a parent-led memory reframing~     intervention to reduce youth's negative memories of surgery. We want to look at how a~     parent-led memory reframing session on youth's post-surgical pain memory.~      The study will include 90 youth who have a chest wall surgery or a spinal fusion surgery at~     the Alberta Children's Hospital. They will be recruited at the Alberta Children's Hospital.~     There will be pain tests in the form of surveys 1-3 weeks before surgery, pain monitoring in~     the hospital for a couple of days, pain monitoring 1-2 weeks after surgery, a clinic visit~     2-4 weeks after surgery for a memory reframing session, and pain monitoring 6 weeks after~     surgery in the form of a telephone interview.~   "
34854|NCT03110354|"~     This research study tests an investigational drug called DS-3201b. An investigational drug is~     a medication that is still being studied and has not yet been approved by the United States~     Food and Drug Administration (FDA). The FDA allows DS-3201b to be used only in research. It~     is not known if DS-3201b will work or not.~      This study consists of two parts. The first part (Part 1) is a dose escalation that will~     enroll subjects with AML or ALL that did not respond or no longer respond to previous~     standard therapy. The purpose of Part 1 of this research study is to determine the highest~     dose a patient can tolerate or recommended dose of DS-3201b that can be given to subjects~     with AML or ALL. Once the highest tolerable dose is determined, additional subjects will be~     enrolled at that dose into Part 2 of the study.~   "
34855|NCT03110341|"~     Preterm and very preterm infants are at risk of developing encephalopathy of prematurity and~     long-term neurodevelopmental delay. Magnetic resonance imaging (MRI) allows the~     characterization of specific features of encephalopathy of prematurity, including structural~     changes of brain white matter and gray matter. This study wants to investigate important~     evidence that early repeated high-dose rhEPO(5250 IU/kg) treatment improves long-term~     neurological outcomes in very preterm infants and without obvious adverse effects.~   "
34991|NCT03108573|"~     This study evaluates different optimized MRI sequences for the detection of brain lesions in~     patients with multiple sclerosis in comparison with the recommended FLAIR sequence~   "
34857|NCT03110315|"~     This study assesses the safety, tolerability, and efficacy of suvorexant in multiple~     sclerosis patients. Enrolled subjects will receive 2 weeks of treatment during treatment~     period 1 with either suvorexant or matching placebo (1:1). After treatment period 1, subjects~     will undergo a washout period of 1 week then 2 weeks of the alternate treatment (either~     suvorexant or placebo). The primary hypothesis is that suvorexant will provide greater~     improvement in sleep, as measured by symptom rating scales, compared to placebo.~   "
34858|NCT03110302|"~     This study will provide a certain type of exposure therapy, called prolonged exposure therapy~     (PE), to military Veterans with Post Traumatic Stress Disorder (PTSD). One hundred and~     seventy-five Veterans will participate in the study. The main study goal is to compare PE~     conducted in three different ways: (1) PE that is office-based (OB; Veterans come to a VA~     clinic and meet with a therapist via telehealth, using videoconferencing technology), (2) PE~     delivered via home-based telehealth (HBT; Veterans stay at home and meet with the therapist~     via telehealth, using videoconferencing technology), and (3) PE delivered in home, in person~     (IHIP; the therapist goes to the Veterans' homes to provide the psychotherapy). Symptoms of~     PTSD, depression, and anxiety will be examined at pre-treatment, post-treatment and at~     six-month follow up to determine if symptoms change over time. Study hypotheses state that~     the IHIP approach, compared to the other two approaches, will be more effective at reducing~     the PTSD symptoms experienced by these Veterans because it will help Veterans attend each~     session and complete the therapy homework assigned by the therapists (such as doing feared,~     but safe, activities around the house or the neighborhood). However, the delivery of IHIP may~     cost more than the delivery of PE via the other modalities.~   "
34859|NCT03110289|"~     The AIM of this study is to investigate whether the FMT success rate in active UC patients~     can be increased by intensive donor pre-screening, anaerobic preparation of the FMT and by~     repeated FMT.~      The investigators will start a national multi-centre double-blind randomized sham-controlled~     trial in April 2017 at 6 hospitals in Belgium and 2 in The Netherlands. They will randomly~     allocate 108 patients with active ulcerative colitis (Mayo score 4-10, endoscopic Mayo score~     2 or 3) in a 1:1 ratio, using a pre-established randomization list, to either 'superdonor'~     faecal microbiota transplantation or autologous fecal microbiota transplantation (=sham).~     Each patient will receive 4 FMT's. At baseline FMT will be performed during sigmoidoscopy. At~     week 1, 2 and 3, the FMT will be administered through rectal instillation. Each FMT will be~     derived from one donor. Donors will be pre-selected based on a species richness and abundance~     of taxa of interest. The primary outcome will be steroid-free clinical and endoscopic~     remission at week 8 (Mayo score ≤2, all subscores ≤ 1, and ≥1 point reduction in endoscopy~     subscore). Fecal, blood and mucosal samples and questionnaires will be collected at different~     time points. 16S rRNA stool analysis will be performed to assess the microbial changes after~     FMT.~   "
34860|NCT03110276|"~     The farnesoid X receptor (FXR) regulates hepatitis B virus replication through the bile acids~     pathway. EYP001a is a selective, synthetic FXR agonist under development for the treatment of~     hepatitis B.~      This Phase 1 study is designed primarily to evaluate the single ascending dose (SAD) followed~     by a multiple ascending dose (MAD) safety, tolerability, and pharmacokinetics of EYP001a in~     healthy male subjects.~   "
34861|NCT03110263|"~     In this study, people who suffer from insomnia will be randomized to one of three study~     conditions. The first group receives a multicomponent internet-based cognitive behavioral~     self-help intervention. The second group has access to an internet-based self-help sleep~     restriction intervention. The third group is a waiting control group. In both active~     conditions additional care or treatment is allowed. The aim of the study is to investigate~     the effectiveness of a multicomponent internet-based cognitive behavioral self-help~     intervention as well as a stand-alone internet-based self-help sleep restriction intervention~     for insomnia symptoms compared to a waiting list. Assessments take place at baseline, and~     8-weeks and 6-months post-randomization. After 8 weeks, participants in the waiting control~     group get access to the internet-based cognitive behavioural self-help intervention and also~     fill out questionnaires at 6-months post-randomization.~   "
34862|NCT03110250|"~     A-HIT2, is also designed as a National FH registry. At least 1000 FH patients will be~     recruited from 30 outpatient clinics representing the 12 Nuts statistical Regions in Turkey~     proportional to the 2015 Turkey's Population distribution.[14] Both HeFH and HoFH patients~     are eligible for enrollment. Sites specialized on cardiology, internal medicine, and~     endocrinology were invited by the Turkish Society of Cardiology.~   "
34863|NCT03110237|"~     Many survivors of acquired brain injury (ABI) suffer from decreased balance and increased~     risks of falls. Previous studies indicate that balance training improves balance, reduces~     falls, and increases walking speed and balance confidence. The purpose of this study is to~     determine if a multidimensional balance training based on the FallProof(TM) approach achieves~     better improvements in balance and walking performance than the current practice .~     Participants will be assigned to: 1)a task-oriented circuit training balance class (current~     practice), or 2) balance training class based on the FallProof(TM) approach. Standardized~     tests will determine if participating in balance training helps improve balance, walking~     speed and balance confidence.~   "
34864|NCT03110224|"~     Post Market clinical outcomes study to collect data on the short - and long-term outcomes for~     subjects who are undergoing or who have undergone the Subchondroplasty (SCP) Procedure in the~     knee in a standard clinical setting. Outcomes to be assessed include pain medication usage,~     pain, function, activity levels and patient satisfaction.~   "
34900|NCT03109756|"~     The trial is a Phase 1 Single Dose PK Study in Adolescent Subjects with Fragile X syndrome~     (FXS) or Angelman syndrome (AS).~        -  The primary objective of the study is to evaluate the pharmacokinetics (PK) of OV101~          following a single 5 mg dose of OV101 in adolescents with FXS or AS.~        -  Secondary objectives are to determine the safety and tolerability of a single 5 mg dose~          of OV101 in adolescents with FXS or AS.~   "
34992|NCT03108560|"~     The incidence rate of ground-glass opacity (GGO) has been increasing these years. A great~     number of retrospective studies suggested that sublobar resection was better for some GGO~     patients. However, no prospective clinical study supports the perspective. This study is~     prospective, multi-center, randomized-controlled. The aim of this study is to investigate~     whether sublobar resection is inferior to lobectomy for cT1N0M0 non-small-cell lung cancer or~     not.~   "
34865|NCT03110211|"~     Purpose and Objective: To determine the effectiveness of a physical therapist first versus a~     primary care physician first for patients entering a primary care setting with a~     musculoskeletal complaint on the outcomes of costs/charges, utilization and healthcare~     satisfaction.~      Study activities and population group: This will be a randomized clinical trial enrolling~     patients who are seeking care to the Duke Outpatient Clinic with a musculoskeletal complaint.~     Patients, adults aged 18 years or greater, that agree to be part of the study will be~     randomized to see a physical therapist first or primary care physician first. All aspects of~     the evaluation and treatment by both providers will be standard care for musculoskeletal~     conditions.~      Data analysis and risk/safety issues: Descriptive data including means and standard~     deviations and counts and proportions of baseline scores will be conducted. Differences in~     total costs/charges, opioid prescriptions, emergency department visits will be calculated and~     tested across groups. Participants may not personally be helped by taking part in this study.~     Participants may experience improvements in pain, function, or other symptoms from physical~     therapy program in this study. There is a minimal risk of loss of confidentiality. If a~     patient chooses not to participate, there will be no effect on their medical treatment and~     the study team will cease contact.~   "
34866|NCT03110198|"~     The research aims to evaluate the efficacy and safety of that mesalazine with hydrocortisone~     sodium succinate for the induction of clinical remission during a 4-week double-blind~     treatment period in active UC (define as total Mayo score of greater than or equal to 4 and~     less than or equal to 10). A total of 528 patients will be randomly divided into three group,~     one will receive mesalazine 4g with hydrocortisone sodium succinate 100mg enema, and the~     other two group will respectively to receive mesalazine 4g and hydrocortisone sodium 100mg~     one times daily for 4 weeks. The end of the study for every patient is the improvement of~     main symptoms.The primary endpoint is the clinical remission after 2 and 4 weeks double-blind~     treatment, defined on the basis of a total Mayo score ≤ 2 points, with no subscore > 1 point.~     The secondary endpoint are endoscopic mucosal healing at week 2 and 4 of double-blind period,~     defined as an absolute subscore for endoscopy portion of the Mayo score of 0 point and the~     change from baseline in Quality of Life at week 4 of double-blind period based on the IBDQ.~   "
34867|NCT03110185|"~     Postoperative delirium - a mental state of confusion, inattention, and impaired thought - is~     a potentially life-threatening condition. As many as half of patients that have heart and non~     heart-related surgery will experience postoperative delirium. Patients diagnosed with~     postoperative delirium have poorer outcomes and longer hospitalizations. Unfortunately, it is~     an under-diagnosed condition with a variable delay in when it appears. Additionally, there~     are no objective tools or tests that can be before or after surgery to anticipate and~     identify those patients who are at risk. Electroencephalography [EEG] and functional magnetic~     resonance imaging [fMRI] have helped us understand the changes in the brain during delirium.~     These suggest that a weakening in correlated activity within a group of brain regions, known~     as the default mode network (DMN), may be related to delirium.~   "
34868|NCT03110172|"~     By taking certain antidepressant in early postoperative period，which is supposed to improve~     the psychological status of patients with osteoarthritis, explore the effect of certain~     antidepressant on the recovery of the early stage after the operation of knee joint~     replacement.~   "
34869|NCT03110159|"~     This is a pilot, phase 2, prospective, comparative study to evaluate the safety and efficacy~     of the combination of Levulan® Kerastick® for Topical Solution and blue light illumination~     using the BLU-U® Blue Light Photodynamic Therapy Illuminator (LevulanPDT).~      The study hypothesis is that post solid organ transplantation patients, highly susceptible to~     non-melanoma skin cancer, can be treated safely and effectively through clinical cyclic~     application of PDT, lessening morbidity and possible mortality for this immunosuppressed~     patient population.~   "
34870|NCT03110146|"~     The objective is to demonstrate feasibility of new 'Magnetic Primary' catheter tracking~     algorithms within the Velocity Research Platform (VRP) by assessing the frequency of~     shift/drift during ablation compared to the current commercial EnSite Precision 2.0.1~      The secondary objective is to evaluate catheter rendering in the VRP system.~   "
34871|NCT03110133|"~     This is a Multicenter, Double-Blind, Parallel-Arm, Placebo-Controlled, Phase 2 Study of the~     Efficacy, Safety, and Tolerability of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects~     with Recurrence of Clostridium difficile Infection~   "
34872|NCT03110120|"~     The aim of the study is to compare the analgesia provided by the serratus plane block with~     local infiltration of the orifices of the trocars after thoracic robot-assisted surgery.~   "
34873|NCT03110107|"~     The purpose of this study is to determine whether a Monoclonal Antibody both by itself and in~     combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors~   "
34874|NCT03110094|"~     Interventional study with minimal risks and constraints, prospective, mono-centric.~   "
34875|NCT03110081|"~     This study aims to assess if Quadratus Lumborum (QL) blocks are non-inferior to epidural~     analgesia for pain control and opioid consumption through the third postoperative day in~     patients having open partial nephrectomy. Patients satisfying all inclusion and exclusion~     criteria will be randomized in a 1:1 ratio to either epidural catheter or QL catheter.~   "
34876|NCT03110068|"~     Presence of microvascular invasion can be estimated preoperatively, by some clinical imaging~     features such as patient characteristics, serum biomarkers and radiological features.~     Contrast-enhanced ultrasonography (CEUS) and contrast-enhanced computed tomography (CECT) are~     routine preoperative conventional examinations for hepatocellular carcinoma (HCC) patients in~     China. Combining features of CEUS, CECT and clinical factors may improve preoperative MVI~     assessment. The purpose of this study is to construct a nomogram for preoperative MVI risk~     estimation with these possible factors.~   "
34901|NCT03109743|"~     The investigators will conduct a pilot randomized controlled trial (RCT) of Sisters-GPS with~     HIV-positive women of color with suboptimal ARV adherence and detectable HIV viral loads~     (VL). Participants will be randomized to Sisters-GPS (intervention involving weekly group~     clinical visits for seven weeks plus social media website) or appointment with an adherence~     counselor (a minimum of 3 visits) (control condition). Data sources will include interviews,~     medical and pharmacy records, and blood samples. The primary outcome will be ARV adherence at~     the completion of the intervention assessed via pill count. The secondary outcome will be HIV~     VL suppression.~   "
34877|NCT03110055|"~     Hepatocellular carcinoma (HCC) is the fifth most common cancer and the second leading cause~     of cancer-related deaths in the world. Hepatitis C virus (HCV) is the most common underlying~     cause of cirrhosis and HCC in the western world. Most patients with HCC present with either~     non-resectable tumor and/or severe underlying liver dysfunction, and are not suitable~     candidates for curative treatments by resection or transplantation. Thus, for the majority of~     patients with HCV related HCC, the only option is prolongation of life without a chance for~     cure. These patients generally have a poor prognosis with a median survival of less than 1~     year. Arterial obstruction of branches of the hepatic artery and simultaneous infusion of~     chemotherapy (Trans-arterial chemo-embolization or TACE) induces ischemic tumor necrosis with~     a high rate of objective tumor responses (30-60%). Overall, the median survival after TACE~     for intermediate HCC is about 20 months, an improvement over supportive care. Treatment with~     Grazoprevir/Elbasvir showed excellent results in phase 3 studies for patients with HCV~     genotype 1 (a and b) and genotype 4 infection and is approved for HCV treatment in the USA,~     Europe and Israel. Anti-HCV therapies may influence HCC biology by decreasing inflammation~     and may thus alter the tumor microenvironment.~   "
34878|NCT03110042|"~     The HILO-HF Registry is a single centre registry that will be performed to provide~     information on the usual baseline oxygen saturation (SpO2) in patients presenting to ED with~     a primary ED diagnosis of AHF~   "
34879|NCT03110029|"~     This study will test how well efinaconazole solution (Jublia) works to treat toenail fungal~     infections in patients who wear polish compared to those who do not.~   "
34880|NCT03110016|"~     The study aimed to examine the feasibility, usability, user satisfaction, safety, and~     preliminary efficacy of a smartphone application intervention for young adults with~     subthreshold depression.~   "
34881|NCT03110003|"~     In this study the investigator will address the efficacy of using low dose bupivacaine spinal~     anesthesia (SA) in combination with epidural volume extension (EVE) for patients undergoing~     short obstetric procedures.~   "
34882|NCT03109990|"~     Dexmedetomidine is widely used as an anaesthetic for general anesthesia during surgery.~     Previous studies in cells and animals show that dexmedetomidine may promote cancer growth.~     The purpose of present study is to examine whether utilization of dexmedetomidine in patients~     undergoing surgery for primary breast cancer increases breast cancer recurrence and~     metastasis, and to investigate its effects on the patients' immune system.~   "
34883|NCT03109977|"~     The purpose of this study is to test if an imaging agent called Zr-DFO-pertuzumab that finds~     HER2 proteins can be used to take pictures of HER2-positive cancer.~   "
34884|NCT03109964|"~     Patients undergoing elective laparoscopic ovarian cystectomy will be recruited and randomly~     divided into 2 groups according to intervention technique-half will be allocated to the~     bipolar coagulation group and half to the SURGIFLO group.~      Patients will be assessed both pre-operatively and 6 months post-operatively by blood tests~     including follicle stimulating hormone (FSH), lutenizing hormone (LH), Estrogen (E2),~     Progesterone and anti-mullerian hormone (AMH) levels, and sonographic evaluation of ovarian~     volume and antral follicle count.~   "
34885|NCT03109951|"~     Type 2 diabetes is rapidly increasing globally and has been associated with an increased risk~     of colorectal cancer. Therefore, the numbers of diabetic patients who will undergo~     colonoscopic screening are expected to grow exponentially. Colonoscopic preparation entails~     prolonged fasting, cessation of anti-diabetic medication and ingestion of preparation~     medications. This may put the diabetic patient at risk of potentially dangerous hypo- or~     hyperglycemia. However, studies regarding the safety of colonoscopic preparation in diabetic~     are lacking. In this study, the investigators aim to discover the prevalence of abnormal~     glucose levels in diabetic patients who undergo colonoscopy. The investigators also aim to~     find out risk factors for abnormal glucose levels and develop a safe preparation protocol.~   "
34886|NCT03109938|"~     Endoscopic diagnosis of lateral spreading tumours (LST) with submucosal invasion is important~     in guiding the treatment strategy. The use of advanced imaging is not standard clinical~     practice in China. A clinical trial is now under way comparing the accuracy of narrow band~     imaging (NBI), endoscopic ultrasonography (EUS) and magnifying chromoendoscopy (MCE) for the~     diagnosis of LST with submucosal invasion.~   "
34887|NCT03109925|"~     This is a study protocol for the use of a novel radiopaque embolic agent in the treatment of~     lower urinary tract Symptoms (LUTS) with prostatic artery embolisation (PAE). This study will~     allow us to evaluate the safety and efficacy of this embolic in PAE along with giving us a~     better understanding of embolic distribution.~   "
34888|NCT03109912|"~     Physical activity (PA) in individuals with cystic fibrosis (CF) improves exercise capacity,~     slows decline in lung function, increases mucus clearance and improves health-related quality~     of life (HRQoL). Establishing and maintaining an exercise routine remains challenging and~     programs promoting PA in people with CF have poor participation. Moreover, while the positive~     effects of physical conditioning on lung function have been well reported, conventional~     measurements of lung function may lack the sensitivity to reveal improvement in mild lung~     disease.~      This randomized control trial (RCT; N = 60) evaluates the Do More, B'More, Live Fit, a~     6-month fitness program designed to optimize exercise habits of 12-21 year-olds with CF~     through structured exercises with personalized coaching, exercise equipment including the~     FitBit Flex, online support and motivational messages delivered electronically. The~     intervention incorporates fitness preferences and encompasses endurance, strength and~     flexibility exercises while adjusting to physical fitness needs. The hypothesis is that~     intervention participants will have increased and sustained engagement and better health~     outcomes compared to control group participants. The investigators' specific aims are to:~        1. Increase daily PA and measures of fitness~        2. Improve lung clearance index (LCI) and participant HRQoL~        3. Demonstrate feasibility, accessibility and satisfaction of intervention using~          semi-structured interviews~      The results of this pilot evaluation of the Do More, B'More, Live Fit program will offer~     novel insight into factors that sustain engagement in exercise programs and identify if LCI~     is an appropriate clinical outcome to assess PA interventions. Results will inform future RCT~     of interventions to optimize exercise habits of adolescents with CF.~   "
34889|NCT03109899|"~     The PHASTT Study is focused on understanding of facilitators and barriers to mHealth use~     among young Black men who have sex with men (MSM), and testing a novel mobile app to increase~     HIV/STI testing and PrEP uptake.~   "
34890|NCT03109886|"~     The primary aim of this exploratory study is to test the safety and tolerability of milciclib~     when administered orally at 100 mg in patients with recurrent or metastatic Hepatocellular~     Carcinoma. The evaluation of the efficacy profile is a secondary objective of the study.~     Moreover, markers expression in tumor cells and plasma will be studied and described in~     association with the clinical outcome.~      Eligible patients will receive milciclib orally on a daily schedule for 4 consecutive days a~     week in a 4-week cycle (4 days on/3 days off x q4 wks) for a total of 12 weeks (i.e. 3~     cycles) unless patient refusal, consent withdrawal, Investigator's decision, unacceptable~     toxicity or death whichever occurs earlier.~      At the end of Cycle 3, treatment will be stopped, and based on the results of the tumor~     assessment performed on Day 90 (±3 days) from treatment start, patients will be followed as~     here below detailed:~        -  patients with Complete Response (CR)/Partial Response (PR)/Stable Disease (SD) will be~          followed for safety until 30 days from last dose intake (or until a new anticancer~          therapy starts, whichever occurs earlier) and will be assessed for efficacy in the~          follow-up period up to Day 180 from treatment start;~        -  patients with progressive disease will be followed only for safety until 30 days from~          last dose intake (or until a new anticancer therapy starts, whichever occurs earlier).~      After the completion of three cycles, patients who, in the Investigator's judgment, are~     benefiting from treatment with milciclib, will resume treatment and will remain on study up~     to Day 180 from treatment start, unless withdrawal criteria are met earlier.~   "
34891|NCT03109873|"~     This pilot clinical trial studies how well metformin hydrochloride works in affecting~     cytokines and exosomes in patients with head and neck cancer. Metformin hydrochloride may~     reduce the metabolic activity of cancer cells and of surrounding supportive tissues.~   "
34892|NCT03109860|"~     The study investigates the effect of an open (in full view of the patient) vs hidden~     treatment (without the patient's knowledge).~   "
34893|NCT03109847|"~     This pilot clinical trial studies how will metformin hydrochloride works in mitigating the~     side effects of radioactive iodine treatment in patients with differentiated thyroid cancer.~     Metformin hydrochloride may reduce the metabolic activity of cancer cell and of surrounding~     supportive tissues.~   "
34894|NCT03109834|"~     Aim of this prospective randomized study was to evaluate whether a diet with meal~     replacements can be as effective as a conventional energy-restricted modified diet on weight~     loss, body composition and cardiometabolic risk profile in overweight women. Moreover, the~     impact of these two different weight management strategies was observed on cardiometabolic~     risk profile after a self-directed weight stabilization phase following the weight loss~     phase. After that, the effect of a specific micronutrient composition with omega-3 fatty~     acids versus placebo on cardiometabolic risk was observed during a following phase of weight~     loss maintenance.~   "
34895|NCT03109821|"~     In this study we will investigate the relation between performed exercise dose and recovery~     after total hip replacement (THA). A dose-response relationship is hypothesized.~      It is the primary objective to indicate the preliminary efficacy of home-based rehabilitation~     using elastic band exercise on performance-based function after THA, based on the~     relationship between the performed exercise dose (objectively quantified time under tension~     summary dose) and the change in 40 meter maximal gait speed (performance-based function) from~     3 (start of intervention) to 10 weeks (end of intervention) after surgery.~   "
34896|NCT03109808|"~     Impact of a personalized video in oral hygiene motivation: The study hypothesis is that the~     use of a personalized oral hygiene video, made available to the patient via a cloud-based~     system, in conjunction with a text-based two-way recall system will increase patient~     compliance, hence leading to improvement or oral hygiene.~   "
34897|NCT03109795|"~     The goal of this study is to evaluate the effectiveness of a short-term (4 weeks)~     pharmacological blockade of sympathetic nerve activity (clonidine) on anxiety symptoms,~     vascular function, inflammation, muscle sympathetic nerve activity, and oxidant stress in~     individuals with moderate-to-high anxiety. Individuals who are interested in the study will~     be identified by an online screening survey and will be contacted by the research team;~     advertisements, flyers and mass emails will direct individuals to the online screening~     survey. Those deemed eligible to participate will be randomized to either the clonidine~     intervention or hydrochlorothiazide as a blood-pressure lowering control condition. If~     eligible participants are currently being treated with blood pressure-lowering medications,~     they will be asked to go off these medications for 2 weeks prior to and during the course of~     the study. During the 2 week washout of blood pressure-lowering medications, participants~     will have safety visits (2 additional visits) that include measurements of blood pressure at~     4 days and 7 days after the beginning of the washout period before the intervention.~     Assessments of anxiety symptoms via various surveys, vascular function (via non-invasive,~     well-established techniques), inflammation, muscle sympathetic nerve activity, and oxidant~     stress will be performed at baseline and at the post intervention session. Similar baseline~     measurements will be performed in control subjects with low or no anxiety for comparison, but~     these individuals will not undergo the intervention.~      Participants with moderate-to-high anxiety will have a total of 6 visits to the laboratory,~     which includes the screening and consent (visit 1). Visit 2 (baseline measurements) and visit~     6 (post-intervention measurements) will be more extensive (~4.5 hours) compared to the other~     visits (~30 min). Participants completing the washout will have an additional 2 visits (~30~     min each) before visit 2. Control subjects with low or no anxiety will only participate in~     visit 1 (screening and consent ) and visit 2 (baseline measurements).~   "
34898|NCT03109782|"~     Traumatic spinal cord injury (tSCI) is a debilitating disease that leads to neurological~     deficits and often has long-term effects including severe lifelong disability. Given the~     devastating personal and economic consequences of SCI, it is critical to collect~     high-quality, prospective data. SCI has not been systemically assessed in Austria, and data~     regarding the etiology, incidence and prevalence are missing or significantly limited. More~     importantly to the individuals suffering from SCI, health care for SCI patients in Austria is~     not concentrated in specialized SCI centers but fragmented, which might result in a less~     effective recovery and rehabilitation of patients. Accordingly, the Paracelsus Medical~     University Salzburg (PMU) and the Austrian Social Insurance for Occupational Risks (AUVA)~     initiated the Austrian Spinal Cord Injury Study (ASCIS) at the beginning of 2012. ASCIS is~     defined as an organized network that uses observational methods to collect uniform~     longitudinal clinical data that can provide insight into current patient care parameters and~     evaluates the outcome of SCI patients. ASCIS was initiated with the aim to develop a registry~     for patients with tSCI in Austria as a base for addressing research questions, improving~     patient outcomes and establishing a platform for future clinical trials. Furthermore, a major~     goal of ASCIS is to get knowledge about the natural recovery after spinal cord lesion in a~     larger population of patients in the sense of a historical control group and bring new~     standardized assessment tools to the clinical setting. Due to the involvement of acute trauma~     hospitals and rehabilitation centers, ASCIS is uniquely positioned to capture detailed~     hospital-related information on the (very)-acute, rehabilitation and chronic phases of tSCI~     patients. Additionally, ASCIS is cooperation partner of the European Multi-Center Study about~     Spinal Cord Injury (EMSCI).~   "
34899|NCT03109769|"~     The study aims to investigate the effect of the use of mobile phone application sending~     reminders to patients with orthodontic fixed appliances on oral hygiene.~   "
34902|NCT03109730|"~     The purpose of this protocol is to obtain pharmacodynamic and pharmacokinetic data on~     ABI-H0731 and to provide the opportunity for preliminary evaluation of combination therapy of~     ABI-H0731 with currently approved antiviral treatment for chronic hepatitis B.~   "
34907|NCT03109665|"~     Glaucoma is the leading cause of irreversible blindness worldwide. It is caused by damage to~     the optic nerve between the back of the eye and the brain leading to progressive blindness.~     The cause is poorly understood but ageing, increased intraocular pressure (IOP) and genetics~     are all likely to play a role. There is no cure for glaucoma but treatments are available~     which slow progression. Because vision cannot be restored once lost, early detection,~     monitoring and early treatment are all essential to preserve visual function.~      The condition is diagnosed using a combination of the appearance of the optic nerve on~     clinical examination or photograph and visual field testing (perimetry). Measurement of IOP~     and measurement of the thickness of the retinal layers at the back of the eye complement~     diagnostic decisions.~      The Northern Ireland Cohort for the Longitudinal Study of Ageing (NICOLA) study does not~     include perimetry in the series of tests carried out on all participants but does include~     photography of the optic nerve, measurement of IOP and measurement of retinal thickness.~     Therefore we propose to invite back participants of the NICOLA study who have abnormal optic~     discs and high eye pressure to return for perimetry to confirm a diagnosis of glaucoma.~     Calling back participants for perimetry is essential to make the diagnosis not only for~     estimating prevalence but also for identifying participant's ill-health.~      The primary aim of this study is to quantify the number of participants in the NICOLA study~     who have glaucoma and report its risk factors. This will allow an estimate of the number of~     people in the whole of NI with glaucoma. We will also perform a series of novel tests using~     state-of-the-art technologies to assess if they are better than current tests at diagnosing~     glaucoma. This may enable better informed decisions about policy decisions in eyecare.~   "
34908|NCT03109652|"~     The usefulness of tranexamic acid(TXA) to reduce blood loss and transfusion in total knee~     replacement arthroplasty(TKRA) has been demonstrated. However, the optimal does, duration of~     treatment and route of administration of TXA to reduce blood loss while minimizing adverse~     effects remain uncertain. Recently, the serial use of perioperative IV and post-operative~     oral TXA has been shown to significantly reduce transfusion rate without increasing~     thromboembolic complications compared to placebo. The aim of this study is to 1) determine~     the beneficial effect and safety of the serial treatment of IV and oral TXA over IV use alone~     and 2) assess the sufficient length of postoperative use of oral TXA in TKRA patients.~   "
34909|NCT03109639|"~     Endoscopic ultrasound guided fine needle aspiration (EUS-FNA) is the technique of choice to~     evaluate solid gastrointestinal (GI) lesions. The tissue acquired using this technique is~     essential for diagnosis of diseases like sub-mucosal masses (GIST), lymphoma, autoimmune~     pancreatitis and pancreatic cancer. Also the availability of adequate tissue will enable~     performance of molecular profiling and personalized oncologic therapy. The current needle~     used for tissue acquisition rarely provides tissue blocks needed for histology assessment.~     Hence, a better needle device with a good safety profile is needed to solve this technical~     difficulty. The new AcquireTM fine needle biopsy device could over come this difficulty~     because of its unique designs. The additional cutting edge surface allows better tissue~     access and provides core tissue (>90%) for histology. The safety profile of this new device~     is comparable to the conventional FNA needle thereby making it an ideal device for tissue~     acquisition.~   "
34910|NCT03109626|"~     The project will study a therapeutic approach in Spinocerebellar Ataxia (SCA38) by DHA~     replacement. SCA38 is caused by missense mutations in the ELOVL5 (Elongation of very long~     chain fatty acids protein 5) gene.~      Background/Rationale: ELOVL5 is a microsomal fatty acid elongase gene required for the~     synthesis of arachidonic acid and DHA. In brain, it shows a peculiar high expression in~     cerebellar Purkinje cells.~      The ELOVL5 products, such as DHA, are decreased in SCA38 patients serum and DHA administered~     as a dietary supplement has been shown to improve SARA scores, to ameliorate quality of life,~     and to increase brain cerebellar hypometabolism (FDG-PET) in two SCA38 patients.~      Experimental Plan: The investigators will perform a randomized placebo-controlled trial by~     DHA supplementation on ten SCA38 patients, followed by an open-label phase.~      Expected results: DHA supplementation should be able to improve symptoms in SCA38 and to~     improve cerebellar hypometabolism in these patients.~   "
34911|NCT03109613|"~     Positive end-expiratory pressure (PEEP) is used in premature infants receiving mechanical~     ventilation to maintain lungs open and facilitate gas exchange. When ventilation/perfusion~     mismatch is present, areas of the lung that are open for gas exchange do not match up with~     areas of the lung that are receiving blood for gas exchange. This study measures the~     feasibility of enrolling and completing study maneuvers in premature infants for a~     prospective study measuring the responsiveness of V/Q mismatch to changes in the amount (or~     level) of PEEP.~   "
34912|NCT03109600|"~     This study is to assess the safety of Vi-DT vaccine in adults and children.~   "
34913|NCT03109587|"~     This study evaluates the feasibility and effect of probiotics on glycemic control in obese~     adolescents.~   "
34914|NCT03109574|"~     This is a prospective, multi-center health economic study in Canada. Participants will be~     randomly assigned to receive either the study or control dialysis catheter. The primary~     objective is to evaluate resource utilization in Ontario related to hemodialysis catheter~     placement including tPA usage, catheter exchange rates, catheter patency, and missed dialysis~     days.~   "
34915|NCT03109561|"~     Impaired metabolism and the gene apolipoprotein E (ApoE) are independent risk factors for~     cognitive impairment and dementia. In humans, there are three major versions of apoE (E): E2,~     E3, and E4. Some studies suggest that the different versions of apoE have varying effects on~     whole body and brain metabolism. The goal of this project is to better understand the~     relationship between apoE and metabolism. This will help investigators identify new targets~     for the prevention and treatment of cognitive decline and dementia.~   "
34916|NCT03109548|"~     The purpose of the project is to associate pre-treatment pain sensitivity level, levels of~     pain catastrophizing and levels of The Subgroups for Targeted Treatment (STarT) Back~     Screening Tool in patients with acute low back pain and patients' progression after 12 weeks~     of treatment by general practitioners.~   "
34917|NCT03109535|"~     The aim of this study is to determine if participants randomized to our mHealth MapTrek game~     increases daily physical activity (average steps/day, active minutes/day) compared to a~     control group among sedentary office workers over 10 weeks. The investigators hypothesize the~     MapTrek intervention group will significantly increase their daily steps and active minutes~     compared to the control group over 10 weeks.~   "
34918|NCT03109522|"~     The purpose of this pilot study is to compare a new surgical technique (axillary reverse~     mapping) to standard axillary surgery in patients diagnosed with invasive or in situ breast~     cancer.~   "
34993|NCT03108547|"~     The investigators studied whether scalp hair cortisol and testosterone levels differed~     between sarcoidosis patients both with and without fatigue and healthy controls.~   "
47621|NCT02943577|"~     This study will evaluate the efficacy, safety, and tolerability of rapastinel 450 milligrams~     (mg) compared to placebo adjunctive to antidepressant therapy (ADT) in patients with major~     depressive disorder (MDD) who have a partial response to ADT.~   "
34919|NCT03109509|"~     Historically, increasing activity was synonymous with exercise; however, it is now thought~     that even much more modest activity levels (e.g., simply walking) or merely decreasing the~     proportion of sedentary time may be sufficient to decrease future morbidity and mortality.~     Some interventions designed to increase activity have shown promise; others have been less~     successful. But even promising interventions are often difficult to generalize to real-life~     clinical settings. One barrier to monitoring the effectiveness of interventions has been the~     lack of availability of accurate, reliable and inexpensive personal activity monitoring~     equipment. The availability of inexpensive pedometers, and, more recently, low cost triaxial~     accelerometers, has now made it much easier to monitor activity levels and provide feedback~     to users. These devices are ideal for capturing activity associated with walking, the most~     popular and acceptable form of exercise, but only if patients actually wear them. Thus, there~     is a need to develop pragmatic approaches that encourage patients to not only wear these~     monitoring devices, but also motivate them to increase their activity.~      In recent years, games have been used in a variety of settings to motivate and change~     behavior. Games not only provide performance feedback to patients, but also provide~     incentives for achieving goals in a context that is fun, intrinsically rewarding, and easy to~     understand. Successful games effectively exploit motivating social factors (e.g.,~     competition, peer support, and entertainment) to maintain interest and engage participants.~     Steps are counted using a commercially available triaxial accelerometer (e.g., a FitBit).~     Pokemon Go is an augmented reality game that encourages players to go outside to search for~     Pokemon creatures.~   "
34920|NCT03109496|"~     This study analyses which bacteria are present in the middle ear space and adjacent upper~     respiratory tract niches in healthy people and in patients suffering from chronic otitis~     media with effusion (OME; glue ear). The aim is to identify and isolate bacteria that are~     more common and more abundant in healthy people and to evaluate their potential to protect~     against bacteria commonly involved in OME and other upper respiratory tract infections.~      To this end, samples will be collected from both groups (healthy vs OME) and analysed through~     sequencing of the bacterial 16S gene. In addition, samples obtained from healthy participants~     will be cultivated to isolate bacteria of interest.~   "
34921|NCT03109483|"~     The aim of this study is to investigate the effectiveness of our developed week-treatment~     program GAPP, on strength, balance, speed, functionality and cognition, with the main goal to~     achieve a better independence for activities of daily living (ADL).~      Each day of the week an exercise program of 45 minutes is given assigned to a specific aspect~     of the rehabilitation; strength, balance, speed, functional training and one day is for~     testing or group therapy.~      Participants will be followed for four weeks, with testing on day one, after two weeks and at~     the last day of the four-week program.~   "
34922|NCT03109470|"~     Patients who participated in the FUNCTION Study (Protocol WA19926) will be enrolled in this~     study. The investigators want to learn how long it takes Early Rheumatoid Arthritis patients~     who were treated with Tocilizumab to require treatment with another biologic medication.~   "
34923|NCT03109457|"~     Compare Hepatiis C Virus (HCV) detection between oral squamous cell carcinoma (OSCC) and~     normal tissues, to determine the possible relationship between HCV and OSCC.~   "
34924|NCT03109444|"~     This study aims to collect normative population data on the ultrasound radiographic~     parameters used to evaluate hip dysplasia in infants between 32 and 46 weeks of gestational~     age. This data would be utilized to develop a growth chart with standard deviations for this~     cohort that would be beneficial in the appropriate treatment of suspected hip dysplasia.~   "
34925|NCT03109431|"~     Optimizing the HIV Treatment Continuum with a Stepped Care Model for Youth Living with HIV~     (YLH) aims to achieve viral suppression among YLH. A cohort of 220 YLH will be identified in~     Los Angeles, CA and New Orleans, LA and recruited into a randomized controlled trial (RCT)~     with reassessments every 4 months over a 24 month follow-up period. The goal is to optimize~     the HIV Treatment Continuum over 24 months. YLH will be randomized into one of two study~     conditions: 1) Enhanced Standard Care Condition (n=110); or 2) Stepped Care (n=110). The~     Enhanced Standard Care condition will consist of an Automated Messaging and Monitoring~     Intervention (AMMI) with daily motivational, instructional and referral text messaging, and a~     brief weekly monitoring survey. The Stepped Care Condition will consist of three levels.~     Level 1 is the Enhanced Standard Care Condition. Level 2 is the Enhanced Standard Care~     Condition plus peer support using social media. Level 3 is the Enhanced Standard Care~     Condition and peer support plus coaching, which will be delivered primarily through~     electronic means (e.g., social media, text messaging, email, phone). All participants in the~     Stepped Care Condition begin at Level 1 but if they fail to have a suppressed viral load at~     any four-month assessment point, their intervention level will increase by one step until~     reaching Level 3.~   "
34926|NCT03109418|"~     The aim of this study is to substantially reduce overall postoperative morbidity and~     mortality associated with obstructive sleep apnea.~   "
34927|NCT03109405|"~     The purpose of this study was to examine the Veinplicity Device as an adjunctive IV~     cannulation tool in subjects with a history of difficult to access veins. The Veinplicity~     Device is intended to improve venous access rates in compromised patients by taking advantage~     of the increased circulation that results from provoked muscle stimulation. The study~     collected information about the device, intravenous access, user and patient perceptions for~     IV access, and any device or procedural complications or other adverse events. Device use was~     examined with patients in both a prone and upright position.~   "
34928|NCT03109392|"~     Flexible bronchoscopy is common procedure used in the diagnosis and treatment of a variety of~     tracheobronchial diseases. During routine diagnostic flexible bronchoscopy, the most~     distressing symptom experienced by the patients is a cough, and control of a cough is vital~     for a successful procedure. The investigators hypothesized that either nebulized lignocaine~     or lignocaine spray given alone prior to flexible bronchoscopy for inducing topical~     anesthesia will have similar efficacy compared to the combination of the two agents.~   "
34929|NCT03109379|"~     The purpose of this study is to determine if TAR-302-5018, an investigational drug-delivery~     system, is safe and tolerable in patients with idiopathic overactive bladder and urinary~     incontinence.~   "
47965|NCT02939092|"~     To evaluate the clinical effectiveness of mouthwash containing pomegranate peel extract and~     chlorhexidine mouthwash on bleeding on brushing and counting of streptococcus mutans among a~     group of Egyptian children with permanent dentition.~   "
34930|NCT03109366|"~     This project's overall objective is to contribute to knowledge and innovation needed to~     advance ICT-arenas for timely, secure and seamless collaboration between chronically ill~     patients and appropriate levels of care. The investigators will expand an Internet solution~     that has successfully supported online patient-provider communication into a device-~     independent mobile, multifunctional ICT platform, called Connect 2.0, to support individually~     tailored collaborative care between patients and care providers on the continuum of~     primary-specialist care. The results will contribute to Norway's Collaboration Reform.~     Integrating theories from health and ICT related sciences, the project is organized into five~     work packages that focus on two of VERDIKTs research themes: social networking and mobile~     internet. We will summarize (1) the current state of collaborative health care models and~     their utilization of ICT research and innovations; explore challenges related to (2)~     information exchange between devices, platforms and systems; (3) human-computer interaction,~     (4) data security and confidentiality; and (5) factors related to successful adoption and~     implementation of Connect 2.0 patient-provider collaborative care. Finally the investigators~     will explore how Connect 2.0 impacts interactions, communication and organizational processes~     in collaborative real world care.~      Specifically this study will:~        1. Summarize the current state of collaborative health care models and their utilization of~          ICT research and innovations.~        2. Explore challenges and propose solutions for adapting a mobile multifunctional ICT~          platform (Connect 2.0) into the technical and organizational infrastructures of~          collaborative health care.~        3. Through user-centred design methods address challenges related to human computer~          interaction and usability of Connect 2.0.~        4. Explore challenges and feasible solutions that safeguard data security and~          confidentiality when connecting an Internet solution with a protected health net while~          ensuring safe and efficient data transfer through heterogeneous networks.~        5. Explore factors related to successful adoption and implementation of Connect 2.0 in real~          world collaborative care. Based on the above: explore impacts of a test version of~          Connect 2.0 on interactions, communication and organizational processes.~      The work expands partnerships between the Centre for research-based innovation (SFI)~     consortium (7 business / research partners) called Tromsø Telemedicine Laboratory (TTL), the~     Norwegian Telemedicine Center (NST), the Center for Shared Decision Making and Nursing~     Research (CSDM) at Oslo University Hospital, the Department of Computer Science, University~     of Oslo, the University Hospital of Northern Norway (UNN), Balsfjord Municipality, the~     Biomedical Information Research Center at the Marshfield Clinic Research Foundation, and the~     Department of Biomedical informatics at Columbia University in New York.~   "
34931|NCT03109353|"~     Extracorporeal photopheresis (ECP), is commonly used for the treatment of cutaneous T-cell~     lymphoma (CTCL) and chronic graft-versus-host disease. ECP (cGVHD) is an immune modulating~     treatment. White blood cells from the patient are standardized activated by a photosensitizer~     psoralen (8-MOP) and irradiated with visible ultraviolet light (UV-A). The purpose is to~     induce programmed cell death (apoptosis). Disadvantage of current treatment is that 8-MOP~     targets both diseased and normal cells with no selectivity.~      The purpose of this study is to improve the current ECP technology using aminolevulinic acid~     (ALA) and UV light. ECP will be carried out in conventional manner except that 8-MOP will be~     replaced with ALA. Systemic ALA / UV light is already approved and used in the detection and~     treatment of disease in humans. The primary objective is to assess its safety and~     tolerability after single and multiple treatment in patients with CTCL or cGvHD.~   "
34932|NCT03109340|"~     Objective: To show the effectiveness of walking with ECE PEDO (Equipment for Clever Exercise)~     comparing supervised treadmill walking corresponding moderate aerobic exercise intensity on~     abdominal obesity and cardiorespiratory capacity.~   "
34933|NCT03109327|"~     The purpose of this study is to establish the clinical utility of the Melanoma Detection~     System (MDS).~   "
34934|NCT03109314|"~     The research deals with amblyopia or lazy eye, a condition that affects about 3% of the~     population, and results in a variety of visual deficits. Recent work suggests that there is~     limited neural plasticity in the visual system of adults with amblyopia. This study is aimed~     at understanding and increasing this plasticity. In this study, the investigators aim to~     understand how the amblyopic brain learns and how this process is affected by a drug called~     donepezil, which is sometimes given as a treatment for Alzheimer's disease. The investigators~     hope that this study will help to identify the chemical components that help the brain to~     learn, as well as the mechanism of amblyopia. The investigators also plan to test the normal~     periphery, as control.~   "
34935|NCT03109301|"~     Background:~      Gastrointestinal stromal tumors (GIST) can cause serious medical problems. The only known~     treatment is surgery. But completely removing a GIST tumor with surgery is often not~     possible. Researchers want to see if a new drug, selumetinib, can help treat these tumors.~      Objective:~      To find out if selumetinib shrinks or slows the growth of GIST tumors and to see its side~     effects.~      Eligibility:~      People ages 3 and over who have one or more GIST tumors and may have neurofibromatosis type I~     (also called NF1). Their NF1 GIST has shown some growth or cannot be completely removed with~     surgery.~      Design:~      Participants will be screened with heart and eye tests and scans.~      Participants will be told what foods and medicines they cannot take during the study.~     Participants will keep a diary of the medicine they take during the study.~      Participants will take selumetinib capsules twice daily on an empty stomach for 28 days in a~     row. This is 1 cycle.~      During the cycles, participants will have study visits. These may include:~      Medical history~      Physical exam~      Blood and urine tests~      Heart tests~      Scans of their tumors~      Eye exam~      Positron emission tomography scan. They will be get radioactive glucose an IV line. They will~     lie quietly in a darkened room for 50-60 minutes then have the scan.~      Participants will answer questions about how they are feeling.~      Participants can stay in the study until they have bad side effects or their tumor grows.~      After finishing treatment, participants will be watched for side effects for 30 days.~   "
34936|NCT03109288|"~     Background:~      In people with multiple sclerosis (MS), brain and cerebrospinal fluid (CSF) biomarkers~     indicate inflammation or disease. Researchers want to see if 4 drugs given alone or combined~     affect MS biomarkers. They want to see if a change in biomarker levels can predict which~     drugs a person with MS might respond to.~      Objective:~      To see if signs of inflammation in CSF help predict a person s response to different drugs.~      Eligibility:~      People ages 18 75 who:~      Are in protocol 09-N-0032~      Have progressive MS~      Can stand and walk a few steps~      Take an MS drug~      Design:~      Participants will be screened in protocol 09-N-0032.~      Participants will take 1 of the 4 study drugs. Researchers will call after 1 month to see how~     they are doing. Some will start a second drug. They may take each drug or combination for up~     to 18 months.~      Participants will have 2 visits a year for up to 6 years. Visits include:~      Medical history~      Physical exam~      Blood and heart tests~      X-rays and scans~      Eye exam and tear collection~      Lumbar puncture: A needle inserted between back bones removes some CSF.~      Lymphocytapheresis: Blood is removed through a needle in one arm and run through a machine.~     The blood is returned through a needle in the other arm.~      A sensor on the forehead records blood flow and oxygen use.~      Participants may get a device for testing at home.~      Participants will stop taking the drugs if they have taken 2 drugs together for 18 months or~     if they do not do well on the drugs.~      Participants will be called 3 months later to see how they are doing.~   "
47966|NCT02939079|"~     This study evaluates the effect of adding fish oil to Fingolimod on some serum cytokines in~     patients with Relapsing-Remitting Multiple Sclerosis.~   "
34937|NCT03109275|"~     The main aim of this project is to develop a new model to characterize brain connectivity and~     its changes with aging. This characterization will be based on new sensitive and specific~     markers, allowing a better understanding of structural and functional brain networks. To this~     end, two complementary MRI methods will be developed: 1) Resting-state functional MRI~     (rs-fMRI) which allows the measurement of cerebral activity in different cortical gray matter~     regions, and 2) high angular resolution diffusion imaging (HARDI) MRI, which allows to~     characterize brain tissue microarchitecture. HARDI sequences will be developed to acquire and~     reconstruct fiber tractography of patient's brains. In combination with conventional MRI,~     both HARDI and rs-fMRI will be used to estimate the connection degree between each pair of~     cortical regions, so- called Connectome. Once generated, brain networks will be quantified~     through numerous graph metrics, such as graph density, global efficiency and assortativity~     (etc.), reflecting the organization and topology of subjects' connectivity with aging.~   "
34938|NCT03109262|"~     This clinical trial studies how well yttrium Y 90 glass microspheres positron emission~     tomography (PET)/computed tomography (CT) works in imaging patients with liver tumors. Images~     produced by PET/CT may provide better information about the distribution of particles, such~     as yttrium Y 90 glass microspheres, delivered for selective internal radiation therapy (SIRT)~     compared to the technetium Tc-99m albumin aggregated single photon emission computed~     tomography (SPECT)/CT images.~   "
34939|NCT03109249|"~     SPARC1613 is chemotherapeutic agent with a wide spectrum of anti-tumor activity. It is used~     extensively in the treatment of advanced carcinomas of the breast, ovaries, lung, and other~     solid tumors.This is pharmacokinetic study of SPARC1613 and Reference1613.~   "
34940|NCT03109236|"~     This proposal translates a hypothesis driven basic research into clinical setting to~     determine the potential of using autologous CD133+ cells to reverse fibrosis and improve~     clinical outcome for patients with end stage cirrhosis. This has significant impact on the~     management of cirrhosis.~   "
34941|NCT03109223|"~     OBJECTIVES:~      Primary:~      The primary objective is to determine whether the mean weight gain over a 16-week interval~     starting on or before 14 days of life differs between infants fed one of two infant formulas~     as their sole source of nutrition: a commercial formula using a canola l fat blend (Control,~     E23) or the same formula containing the human milk oligosaccharide (Test (HMO)~     2-fucosyllactose (2FL). Mean weight gain also will be compared to that of a concurrently~     enrolled reference group of exclusively breastfed infants.~   "
34942|NCT03109210|"~     This two-site randomized clinical trial will investigate and compare three treatments for~     insomnia in patients who have been diagnosed with and treated for sleep apnea: online~     cognitive behavioral therapy (OCBT), therapist-directed cognitive behavioral therapy (TCBT),~     and standard clinical care. 384 patients will be recruited and will attend up to 15 visits~     over 10 months. Visits will include baseline assessment, treatment visits, and post-treatment~     follow-up visits. Visits will involve completion of questionnaires, meeting with therapists,~     and a physical exam.~   "
34943|NCT03109197|"~     The purpose is to increase the understanding of the characteristics, circumstances, medical~     histories and pathologies of children from ages 11 months through 18 years who have died~     suddenly and unexpectedly, and in some instances, without explanation. The SUDC Registry and~     Research Collaborative will analyze cases of sudden unexpected deaths in these children to~     understand risk factors and causes, and develop preventative measures.~   "
34944|NCT03109184|"~     This study will develop and test a web-based intervention to enhance emotion regulation~     skills and parent-son relationship communication to decrease adolescent boys' risk for dating~     violence involvement as well as attitudes supporting relationship aggression.~   "
34945|NCT03109171|"~     This is a prospective double blinded randomized crossover controlled trial aiming at~     validating the measurement of laryngopharyngeal mechanosensitivity in patients with suspected~     OSA using a recently developed laryngopharyngeal endoscopic esthesiometer and rangefinder~     (LPEER).~      Subjects will be recruited from patients with suspected OSA referred for baseline~     polysomnography to a university hospital sleep laboratory. Intra- and inter-rater reliability~     will be evaluated using the Bland-Altman's limits of agreement plot, the intraclass~     correlation coefficient, and the Pearson or Spearman correlation coefficient, depending on~     the distribution of the variables. Diagnostic accuracy will be evaluate plotting~     Receiver-operating-characteristic-curves (ROC-curves) using as reference standard basal~     polysomnogram. The sensory threshold values for patients with mild, moderate, and severe OSA,~     will be determined and compared using ANOVA or Kruskal Wallis test, depending on the~     distribution of the variables.~   "
34946|NCT03109158|"~     Part 1 of this study will establish a recommended Phase II (RPII) dose for the triplet~     combination of NC-6004 plus 5-Fluorouracil (5-FU) and cetuximab. Part 2 will provide the~     efficacy signal of the triplet combination in this patient population.~   "
34947|NCT03109145|"~     The purpose of this research study is to examine the impact of educational secure messages on~     menopause. In particular, the investigators will examine whether the secure messages increase~     menopause knowledge and communication between patients and their providers.~   "
34948|NCT03109132|"~     The purpose of this test is to evaluate the comfort level of several model configurations of~     the Smart CapnoLine plus cannula The test focuses on the comfort / discomfort generated by~     the device, mainly due to tubes around the ears and on the face skin, the cannula itself~     (especially in the nostrils and the mouth surrounding) and the smell.~   "
34949|NCT03109119|"~     This study aims to find out if sevoflurane causes any cell damage to patients undergoing~     general anaesthesia. In case of any damage, the reversibility of the damage is also assessed.~     This is a prospective, comparative study carried out in all children scheduled for surgical~     repair of cleft lip or palate admitted in the Department of Plastic Surgery under Smile Train~     organisation ìn our hospital,who satisfy the inclusion and exclusion criteria.~   "
34994|NCT03108534|"~     The clinical trial is designed to evaluate the non-inferiority of CHF1535 100/6 µg NEXThaler~     versus CHF1535 100/6 µg pMDI on the onset of relief from methacholine-induced bronchospasm,~     in terms of pulmonary function (i.e. change in Forced Expiratory Volume in the 1st second,~     FEV1, from baseline to 5 min after study drug intake) in asthmatic patients.~   "
48254|NCT02935309|"~     This research study is designed to see if Capecitabine and Lenvatinib in combination with~     external radiation therapy are effective in treating locally advanced rectal adenocarcinoma~     in patients who have not yet had surgery, and what the best dosage is.~   "
34950|NCT03109106|"~     Antibiotics are overused in hospitals nationwide, leading to unnecessary drug costs and~     adverse events. Antibiotic stewardship is now a national and international priority and~     regulatory authorities are mandating antibiotic stewardship programs in all hospitals.~     Respiratory infections account for a large percentage of antibiotic overuse. Procalcitonin~     has been shown to help providers significantly shorten the duration of antibiotic therapy in~     respiratory infections. As such, this institution seeks to evaluate the impact of PCT-guided~     antibiotic management on antibiotic use in subjects with acute Lower Respiratory Tract~     Infection (LRTI) with or without sepsis. Multiple studies have been conducted in Europe and~     demonstrate the safety of the PCT-guided antibiotic management in pneumonia as well as~     sepsis. This study will apply PCT-guided therapy to those populations in an all-US study~     evaluating patient outcomes along with safety and efficacy.~   "
34951|NCT03109093|"~     This study is designed to confirm the efficacy, safety, and tolerability of blinatumomab in~     patients with MRD of B- precursor ALL in complete hematological remission including patients~     with relapse after SCT. The study aims to expand experience generated in previous trials in~     patients with MRD positive ALL with a focus on additional specific questions.~   "
34952|NCT03109080|"~     A Phase I of Olaparib with Radiation Therapy in Patients With Inflammatory, Loco-regionally~     Advanced or Metastatic TNBC (triple negative breast cancer) or Patient With Operated TNBC~     with Residual Disease.~   "
34953|NCT03109067|"~     Reverse cholesterol transport (RCT) pathway explains the anti-atherosclerosis role of HDL.~     Post prandial hypertriglyceridemia is highly predictive of atherosclerosis. TaqIB~     polymorphism in CETP gene plays a role on HDL particles, and might give a link between TaqIB~     polymorphism and the cardioprotective efficiency of HDL particles. Our main objective was to~     compare post-prandial HDL particles between patients having B2 allele carriers (genotype AA)~     to B1 allele carriers (genotype GG), and their ability to mediate cellular cholesterol~     efflux, via SR-BI Scavenger Receptor class B type I (SR-BI) , ABCG1 and ABCA1 pathways.~   "
34954|NCT03109054|"~     Bariatric surgical procedures are associated with low short-term mortality and may be~     associated with long-term reductions in all-cause, cardiovascular, and cancer-related~     mortality. This surgeries are major surgeries include risk of mortality still.~      Different level anxiety that can define as fear or worry can be seen in 60%-80% of patients~     scheduled surgery. Anxiety levels; may vary on age, gender, type of operation, previous~     experience of anesthesia and surgery and way of hospitalization. Preoperative anxiety affects~     negatively the surgery, the anesthesia and postoperative recovery.~      Melatonin is a hormone secreted from the pineal gland. The circadian rhythm of melatonin~     changes according to age and it's production decreases with older ages. Melatonin is an~     antioxidant, antinociceptive, hypnotic, anticonvulsant, neuroprotective, anxiolytic,~     sedative, analgesic and has a preventive effect of delirium in intensive care. Irregularity~     of melatonin secretion causes a sleep irregularities, psychosis in intensive care unit and~     some behavioral disorder. It has been demonstrated that oral exogen administration of~     melatonin was effective on preoperative anxiety.~      The aim of this study was to determine the relationship between endogenous melatonin levels~     and anxiety levels in patients with bariatric surgery.~   "
34955|NCT03109041|"~     This is a Phase I evaluation to determine the usefulness of a new brachytherapy device that~     utilizes active components (Palladium-103) of standard devices in a novel configuration. This~     study may benefit resectable pancreatic cancer patients by reducing the radiation dose to~     adjacent critical structures, while giving a therapeutic dose to diseased tissue, such as at~     a surgical margin.~   "
34956|NCT03109028|"~     The objective of this study is to investigate a stepped and collaborative care model (SCCM)~     for adolescent and adult refugees suffering from depression living in Germany.~   "
34957|NCT03109015|"~     The purpose of this study is to determine the effect of a sunitinib administration schedule~     2/1 (2 weeks of treatment followed by 1 week without) compared to a schedule 4/2 (4 weeks of~     treatment followed by 2 weeks without) on cardiopulmonary function in subjects with renal~     cell carcinoma. Subjects will be randomized 1:1 to one of two arms: 4/2 schedule of sunitinib~     administration or 2/1 schedule of sunitinib administration. Cardiopulmonary function will be~     assessed at baseline, week 4 (4/2 schedule only), week 5 (2/1 schedule only) and week 12. The~     investigators hypothesize that schedule 2/1 of sunitinib is not only better tolerated but~     will be associated with less fatigue and functional cardiovascular/muscular toxicity than the~     4/2 schedule.~   "
34958|NCT03109002|"~     The purpose of this study is to describe the epidemiology of Treatment Resistant Depression~     (TRD) in the US, including the population incidence of TRD, and TRD as a proportion of~     Pharmacologically Treated Depression (PTD), and stratify the estimates by sex and age group,~     with separate estimates for the Medicaid population, the Medicare population, and the~     privately insured population. Anonymized participants data will be used for the analysis.~   "
34959|NCT03108989|"~     Sugammadex has been approved as the first targeted reversal binding agent providing~     predictable and complete reversal of neuromuscular blockade induced by rocuronium or~     vecuronium, and achieving so with a favourable safety profile.~      Its benefits over traditional acetylcholinesterase inhibitors have been widely demonstrated~     in many studies. The scope of such studies has been mostly related to the efficacy of NMB~     reversal and safety. However, the clinical use of sugammadex led some anaesthesiologists to~     observe that following the use of this agent, patients seemed to recover consciousness faster~     and look like they were feeling better. To present, there is little information on the effect~     of sugammadex on awakening from anaesthesia.~      The quality of postoperative recovery focused around patient-oriented endpoints has raised~     new interest as a measure of the quality of anaesthesia and a target towards which~     improvement can be directed.~      On the other hand, there is no single prospective study performed to address a possible~     effect of sugammadex on recovery from anaesthesia.~      The objective of this study was to compare the effect of sugammadex and neostigmine on the~     quality of postoperative recovery using the PQRS in elderly patients undergoing trans pars~     plana vitrectomy with general anesthesia~   "
35139|NCT03106636|"~     Randomized Trial of KEEP-P, a Preventive Intervention for Foster Preschoolers (KEEP-P). The~     goal of the proposed study is to conduct a randomized clinical trial of a new, low-cost,~     manualized, group-based intervention for preschoolers and their caregivers. The investigators~     will examine the extent to which the two intervention conditions show improved parenting,~     reduced rates of disrupted placements, and improved child outcomes.~   "
34960|NCT03108976|"~     Autistic spectrum disorders (ASD) are highly debilitating developmental syndromes which core~     feature is social and communications disorders. Motor skill impairments are frequently~     described in autism, but few studies have addressed the question of their origin and their~     specificity. Furthermore, it is not clear whether motor problems encountered in autism are~     related to dyspraxia, or if they present with specific features. This project aims at~     deciphering the origin of motor problems encountered by children who grow-up with autism in~     order to propose early interventions that could influence the other developmental~     trajectories, such as the social one.~      Brain dynamics during sensori-motor learning is explored by applying magnetoencephalography~     (MEG) during the Bimanual Load-Lifting paradigm. Different motor processes namely:~     proprioceptive monitoring, use and update of a sensori-motor representation, anticipatory~     executive control will be correlated to brain oscillation modulation, both topographically~     and temporally. Two groups of children (aged between 7 and 12) are compared: a group of~     children with ASD and a control group of typically developing children.~   "
34961|NCT03108963|"~     L-carnitine and plus metformin in clomiphene-resistant obese PCOS women, reproductive and~     metabolic effect: a randomized clinical trial~   "
34962|NCT03108950|"~     The specific aim of the study in our example is to conduct a feasibility translational~     home-based exercise trial established in the LEADERS (R2) project with the TExt-ME~     tele-exercise training system for participants with neurologic disability. We hypothesize~     that participants in this home-based tele-exercise training program will achieve similar~     gains in health and function outcomes as the onsite exercise training program. Further, there~     will be no difference in adverse side effects (safety) between the home-based and onsite~     exercise treatment groups.~   "
34963|NCT03108937|"~     Dexmedetomidine is widely used as an anaesthetic for general anesthesia during surgery.~     Previous studies in cells and animals show that dexmedetomidine may promote cancer growth.~     Using serum from breast cancer surgery patients randomized to receive dexmedetomidine or~     saline during surgery, we investigated the effects of dexmedetomidine on proliferation,~     migration and metastasis in MCF-7 breast cancer cells in vitro.~   "
34964|NCT03108924|"~     This trial aims to evaluate the plasma pharmacokinetics of gefapixant (MK-7264) administered~     to participants with varying degrees of renal insufficiency (RI) compared to healthy matched~     controls; and to investigate the extent of MK-7264 removal by hemodialysis in participants~     with end stage renal disease (ESRD), following administration of a single 50 mg dose of~     gefapixant.~   "
34965|NCT03108911|"~     This randomized phase II trial studies how well a gluten free diet works in diminishing side~     effects in patients with acute myeloid leukemia undergoing induction chemotherapy. A gluten~     free diet may result in less intestinal side effects and blood infections during the~     induction chemotherapy compared to a standard diet.~   "
34966|NCT03108898|"~     The purpose of this study is to better understand how esophageal cells change with age.~   "
34967|NCT03108885|"~     To prospectively collect blood and tumor tissue from esophageal cancer patients to identify~     specific esophageal cancer mutations that can be measured in the blood (cell free DNA) during~     the course of treatment as a marker of response and recurrence.~   "
34968|NCT03108872|"~     We will compare long-term effectiveness and safety in patients with atrial fibrillation~     treated with left atrial appendage occlusion versus new oral anticoagulants to prevent~     ischemic stroke from multicenter registry data~   "
34969|NCT03108859|"~     To establish a spine injury and spinal cord injury (SCI) treatment database; to complete pre-~     and in-hospital evaluation of spine injury and SCI, develop and optimize first aid~     procedures, form pre-and in-hospital standardized training program for the treatment of spine~     injury and SCI; to develop first aid guidelines and establish an evaluation and treatment~     system for early surgery, as far as possible to save the spinal cord function and reduce the~     degree of disability; to form expert consensus on acute SCI and green channel patterns,~     will be promoted in hospitals in Beijing and other cities of China, so as to improve the~     level of first aid treatment of acute spine injury and SCI in Chinese cities, and to reduce~     the occurrence of secondary injury and severe dysfunction due to improper treatment.~   "
34970|NCT03108846|"~     The purpose of this study is to evaluate the safety and efficacy of escitalopram for~     agitation in Alzheimer's dementia.~   "
34971|NCT03108833|"~     This trial is being conducted to assess the efficacy and safety of recombinant Human~     Prourokinase in the acute pulmonary embolism.~   "
34972|NCT03108820|"~     This proposal aims to conduct a randomized controlled trial to evaluate the efficacy of a~     6-month collaborative care intervention in improving the functional and psychological~     recovery of 430 injury survivors 50 and older. The trial has the following specific aims: 1)~     Evaluate the ability of the TMH intervention to improve the physical recovery of older injury~     survivors; and 2) Evaluate the ability of the TMH intervention to improve the psychological~     recovery of older injury survivors; and 3) Evaluate the ability of the TMH intervention to~     reduce healthcare costs of older injury survivors and evaluate the cost of effectiveness of~     the TMH intervention.~   "
34973|NCT03108807|"~     The aim is to determine if the National Early Warning Score combined with plasma D-dimer~     levels can be used in risk stratification of acutely ill medical patients presenting to a~     Danish Emergency Department. The investigators wish to identify patients at low risk of~     mortality within 30 days.~   "
34974|NCT03108794|"~     CR-HepB registry started in June 30,2012 to collect HBV cases from general hospitals or~     specialized hospitals for infectious diseases in mainland China. Demographics, diagnosis,~     laboratory test results, family history and prescriptions were recorded. The main criteria~     for registration is HBsAg-positivity more than 6 months, and these patients will receive~     followed-up visits every three to six months.~   "
34975|NCT03108781|"~     Testing of Lavender Oil aromatherapy effect on behavior disorders in patients with severe~     dementia who are hospitalized in the ward for the mentally frail.~   "
34976|NCT03108768|"~     A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted~     on hard of participants with a hearing loss to grant quality control prior to product launch.~     The aim of the investigation series is to ensure zero-defect overall performance of the new~     hearing systems as well as maximum benefit for the participant with the devices in comparison~     to previously outstanding Phonak Hearing Systems.~   "
34977|NCT03108755|"~     This is a combined Single and Multiple Ascending Oral Dose Study. Part 1 is a Single~     Ascending Dose (SAD) and Part 2 is Multiple Ascending Dose (MAD).~      The purpose of the study is to evaluate the safety and tolerability of single and multiple~     ascending oral doses of ASP7713 in healthy non-Japanese (Part 1) and Japanese (Part 2) adult~     participants and non-Japanese elderly participants (Part 2).~      This study will also evaluate the pharmacokinetics of single and multiple ascending oral~     doses of ASP7713 in non-Japanese (Part1) and Japanese (Part 2) adult participants and~     non-Japanese elderly participants (Part 2) as well as the effect of a single and multiple~     oral dose of ASP7713 on the QT interval using Fridericia's Correction (QTcF).~      In addition, this study will evaluate a potential racial difference in safety, tolerability~     and pharmacokinetics of multiple oral doses of ASP7713 in healthy non-Japanese and Japanese~     adult participants (Part 2).~   "
34978|NCT03108742|"~     In this study, a randomized controlled study was conducted between two groups of 20 classic~     recipients of intradermal sutures and 20 recipients of intradermal staple methods for~     patients undergoing the same cervical incision. This is a study to see if there is any~     difference in pain and esthetics in scar formation of these groups.~   "
34979|NCT03108729|"~     A pediatric drug study to determine the long-term safety and tolerability in children and~     adolescents (4-17 years in age) taking the drug (elsicarbazepine acetate)~   "
34980|NCT03108716|"~     To compare the effects of hamate hook removal, microscrew internal fixation and plaster~     fixation on fracture healing, work, life, and exercise recovery in patients with hamate hook~     fractures by retrospective case analysis.~   "
34981|NCT03108703|"~     Stereotactic body radiotherapy (SBRT) is an emerging radiotherapy technique that precisely~     delivers high doses of radiation to tumours. It has been investigated as definitive treatment~     for an increasing variety of primary tumours including lung, liver, prostate, and now renal~     cell carcinoma (RCC). The principal aims of this study are to prospectively assess quality of~     life (QoL) and oncologic outcomes in non-surgical patients who receive SBRT for the treatment~     of RCC.~   "
34982|NCT03108690|"~     The study investigates whether Therapeutic Drug Monitoring (TDM) and continuous infusion (CI)~     of beta-lactam antibiotics optimises target concentrations in patients with bacteraemia.~   "
34983|NCT03108677|"~     The purpose of this study is to learn whether the profile of RNA from circulating exosomes~     can be used as a biomarker for lung metastases of primary high-grade osteosarcoma.~     Circulating exosomes plays roles in metastases in many kinds of cancer including~     osteosarcoma. By RNA profiling researchers may find lung metastases earlier than conventional~     work-up and predict the oncological outcomes.~   "
34984|NCT03108664|"~     The purpose of this study is to determine whether SYL1001 ophthalmic solution is safe and~     effective in the treatment of signs and symptoms of Dry Eye Disease.~   "
34985|NCT03108651|"~     About 100 (50 from TMU Hospital and 50 from Wellcome Clinic) current smokers will be~     recruited who contact smoke cession clinics in teaching hospitals of Taipei Medical~     University (TMU) and Wellcome Clinic. They will be randomly assigned either to Usual Care~     (UC) or Usual Care plus 3M4Chan Intervention group (IG). A randomized comparative~     effectiveness trial will be conducted. Patient will enroll from September 2017 to May 2018.~     In UC group, the physician provides a brief advice to quit during first consultation, a quit~     plan template, and medication prescription (Varenicline, Bupropion, Champix, Nicotinell~     TTS20) as decided by the physician. IG group includes UC plus a mobile App that is programmed~     to push tailored messages for health concern and readiness to quit, tips for sustaining~     abstinence, use of interactive self-assessments, helpful cessation information. This group of~     smokers will benefit from tailored cessation interventions with integrated body weight~     management elements that take into consideration the prevailing local and cultural influences~     on diet and levels of physical activity. IG will be continued even after stopping of the UC.~   "
34986|NCT03108638|"~     Opportunities to implement and evaluate system-wide change are rare. This observational,~     Hybrid II study leverages a real-world, system-initiated roll-out of R3, a~     supervisor-targeted implementation strategy aimed at infusing the use of evidence-based~     principles across multiple levels of the workforce within a public child welfare system. This~     project aims to study the effectiveness of R3 in impacting organizational inner-context~     variables and subsequent positive outcomes for one of the nation's most costly and vulnerable~     populations—families involved in the child welfare system.~   "
34987|NCT03108625|"~     Evaluation of the long-term safety and tolerability of vortioxetine in child and adolescent~     patients with a Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5™)~     diagnosis of MDD~   "
34988|NCT03108612|"~     The aim of the study is to evaluate the diagnostic accuracy of an instrument (semi-structured~     interview) called Workload Analysis Instrument (WAI) (Análisis de Carga de Trabajo ACT), in~     detecting the presence of occupational risk in patients presenting an upper-limb~     musculoskeletal disorder. The test instrument was developed by Asociación Chilena de~     Seguridad (ACHS). This instrument will be applied to the worker when he or she visits the~     ACHS health care facility. The test administration is performed by an ergonomics specialist~     previously trained in WAI. WAI is the index test and the gold standard will be the Estudio de~     Puesto de Trabajo (EPT) resolution. The hypothesis of the study is that WAI is able to~     correctly label the occupational origin (rule in or rule out) of an upper-limb~     musculoskeletal disorder. Sensitivity, specificity and positive predictive value will be~     established.~   "
34989|NCT03108599|"~     The current project is a safety and health intervention focused on sleep and fatigue among~     truck driver teams (pairs), where one driver sleeps in a moving vehicle while the other~     partner drives. This study is conducted within the Oregon Healthy Workforce Center (OHWC), a~     NIOSH Center of Excellence in Total Worker Health. We will evaluate engineering and~     behavioral interventions to improve sleep, reduce fatigue, and impact Total Worker Health. An~     enhanced cab intervention will alter whole body vibrations during driving and sleep periods,~     and includes a therapeutic mattress system and an active suspension seat. The enhanced cab~     will be evaluated alone and in combination with a behavioral sleep intervention adapted from~     our effective SHIFT (Safety &Health Involvement For Truckers) program. The interventions~     prioritize hazard reduction according to the hierarchy of controls, and will be evaluated~     with a randomized controlled design.~   "
35140|NCT03106623|"~     The objective of the study is to evaluate the efficacy and safety of ONO-8577 compared to~     combination of solifenacin succinate and mirabegron or placebo for overactive bladder~   "
34995|NCT03108521|"~     With the development of pharmacogenomics and pharmacogenetics, personalized medicine based on~     genetic are increasingly required clinically. Incretin-based therapy is currently the most~     popular diabetes treatment. This study mainly research the correlation of incretin-related~     gene polymorphism and individual differences in the response of these drugs from the~     following four aspects.~        1. . To study Chinese human gene polymorphism's mutation frequency and allele frequency, by~          screening Chinese people gene polymorphisms which affecting DPP-4 enzymatic activity.~        2. . To study the mutation frequency of DPP-4 mutation site(rs12469968, rs3788979,~          rs2284872, rs7565794) and GLP1R mutation site(rs3765467) in Chinese population.~        3. . By collecting clinical parameters and efficacy indicators to reveal the relationship~          between Chinese DPP-4 gene and GLP1R gene polymorphism on the clinical manifestations~          and drug response. This study will be improved based on actual experimental research~          methods, and design intervening measures for Chinese people, to explore the dose-effect~          relationship of DPP-4 and GLP1R gene polymorphism in the treatment of diabetes in~          Chinese population.~        4. . Incretins is a new generation hypoglycemic agent. By studying gene polymorphism and~          drug response, to research how to plan treatment for clinical diabetes with DPP-4 and~          GLP1R gene polymorphism. Provide the basis for individualized treatment of these drugs.~   "
34996|NCT03108508|"~     The objective of the present study is to evaluate the non-inferiority of the absorption~     parameters of three silicon supplements in human volunteers.~   "
34997|NCT03108495|"~     Prospective, multicenter, single-arm, open label, interventional study evaluating adoptive~     cell therapy (ACT) with autologous tumor infiltrating lymphocytes (TIL) infusion (LN-145)~     followed by IL-2 after a non-myeloablative (NMA) lymphodepletion preparative regimen for the~     treatment of patients with recurrent, metastatic, or persistent cervical carcinoma~   "
34998|NCT03108482|"~     This is a Phase 3, randomized, double-blind, controlled, parallel-group, multicenter clinical~     trial with co-crystal E-58425 compared to tramadol, to celecoxib, and to placebo. The primary~     objective of the trial is to establish the analgesic efficacy of co-crystal E-58425 by~     demonstrating a superior effect compared to tramadol and to celecoxib for the management of~     moderate to severe acute post-operative pain for 48 hours after bunionectomy.~   "
34999|NCT03108469|"~     The purpose of this study is to evaluate the safety, tolerability, and changes in the number~     of migraine and headache days with repeated subcutaneous administration of IONIS-PKKRx (ISIS~     546254) or placebo in subjects with chronic migraine.~   "
35000|NCT03108456|"~     This trial will evaluate Orbital Atherectomy compared to conventional balloon angioplasty~     technique for the treatment of severely calcified lesions prior to implantation of~     drug-eluting stents (DES).~   "
35001|NCT03108443|"~     Current methods of detecting glaucoma and monitoring its progression over time involve visual~     assessment of the optic nerve, thickness measurements of nerve tissue in the eye (using~     optical coherence tomography, OCT) as well as functional tests which measure peripheral, or~     side, vision. The objective of this study is to determine if a new technique of measuring~     blood flow in the eye, using OCT, can be used to better detect and/or monitor changes in~     glaucoma patients and suspects than these methods.~   "
35002|NCT03108430|"~     Inhalation pneumonia (PI) is common in clinical practice but is rarely studied. For example,~     there are no data on the incidence of pneumonia after inhalation and risk factors or~     protective factors to develop one since it is known that anyone who inhaled does not~     necessarily develop an IP. There is no data on the benefit of treating inhalation by~     antibiotic therapy pre-emptively although this practice is common. In this context, this~     observational study wishes to take stock of the situation on the subject in order to~     determine what actions to implement to prevent IP.~   "
35003|NCT03108417|"~     This study is designed to determine whether subjects who were responders to cNEP during an~     overnight sleep lab titration in a previous clinical trial, Study SOM-012, will maintain a~     response throughout the night for up to two weeks in a home setting. It will also be~     determined whether two weeks of home use of cNEP is associated with any adverse events.~   "
35004|NCT03108404|"~     Pretern premature rupture of the membranes (PPROM) remains the leading cause of preterm~     deliveries and neonatal mortality and morbidity. PPROM is defined as rupture of the fetal~     membranes prior to 37 weeks' gestation. PPROM complicates 2-4% of all pregnancies and~     accounts for approximately 30 % of preterm births.~      The etiology of PPROM remains elusive. PPROM is one of the main causes of prematurity and its~     complications, such as newborn respiratory distress syndrome, neonatal sepsis, necrotizing~     enterocolitis, intraventricular hemorrhage, perventricular leucomalacia, varying degrees of~     lung hypoplasia and bronchopulmonary dysplasia. All these factors contribute greatly to an~     increase in neonatal morbidity and mortality Management of PPROM followed actual guidelines.~     Conservative management to prolong a pregnancy is a classical approach to treat PPROM before~     34 weeks' gestation in association with antibiotic therapy and corticosteroids.~      Maternal and neonatal data were collected from maternal and newborns medical records.~   "
35005|NCT03108391|"~     The study is designed to compare the performance of the Ambu AuraGain Laryngeal Mask Airway~     and LMA Supreme in normal airway patients.~   "
35006|NCT03108378|"~     Subjects must be scheduled to undergo an orthopedic surgical procedure. Subjects in the~     non-control group must have previously received an MRI with MultiHance or ProHance with at~     least 1 month between the last administration and the scheduled surgery. Subjects who have~     never received MultiHance or ProHance or any other gadolinium agent will also be enrolled.~     Subjects must have a test of their kidney function (SCr) at the time of the last MRI~     examination or at the time of enrollment if they never received gadolinium.~      A sample of bone and skin will be collected from the scheduled surgery and tested for the~     amount of gadolinium. An additional sample of skin will be collected for testing the presence~     of nephrogenic systemic fibrosis (NSF).~   "
35007|NCT03108365|"~     The rationale of this study was to evaluate the efficacy of Axiostat hemostatic dental~     dressing in achieving hemostasis post-extraction and determining its effect on pain and~     healing of the extraction wound, compared to control, i.e. conventional method of extraction~     in patients on oral anti-platelet therapy.~   "
35008|NCT03108352|"~     The purpose of this study is to verify the efficacy and safety of intravitreal injection of~     conbercept in patients with macular edema (ME) caused by branch retinal vein occlusion~     (BRVO).~   "
35009|NCT03108339|"~     Low-back pain (LBP) is a complex and heterogeneous disorder commonly seen in primary health~     care. Despite a variety of treatment options available, it seems that few of these prevent~     recurrent LBP and chronicity. In addition, when comparing different treatment options, effect~     sizes are not impressive, indicating that we either lack effective treatment for LBP,~     diagnose poorly or that we measure the outcome of treatment incorrectly. Sub groups within~     the heterogeneous group suffering from LBP need to be identified and also markers influencing~     treatment efficacy. The project aims to conduct a cohort study with the objective to identify~     prognostic markers and sub groups for a successful or poor outcome of low-back pain and~     disability in short and long term. We aim to follow the trajectory of pain, to study~     interactions of markers and associations with days of pain and activity level. We will~     include people seeking physiotherapy care for a primary complaint of LBP to collect data on a~     core set of outcome measurements concerning pain, functional limitations, health and quality~     of life, self- efficacy and fear avoidance. The data will be collected at baseline, at 8~     weeks and 6 and 12 months following an intervention of guideline recommended~     physiotherapeutic care comprising information to stay active and exercises enhancing core~     stability supervised by experienced physiotherapist. We aim to collect data on movement~     control of the lower back and general excessive mobility of the joints at base line. We will~     collect longitudinal data on days with troublesome pain and activity level through~     text-messages sent every 2 weeks. We will analyze the data with mixed model regression~     analyses and cluster analyses to be able to identify predictive factors and interactions to~     sub group the participants.~   "
35010|NCT03108326|"~     RUN-CD is an investigator initiated Non interventional Trial on biologics in Crohn´s~     Disease (CD) patients in Germany with a prospective documentation of effectiveness in~     induction and maintenance therapy of biologics, especially of Ustekinumab, with a special~     interest on predictors of long-term responses and favorable disease outcome and documentation~     of severe side effects caused by the therapy with biologics.~   "
35011|NCT03108313|"~     Patient's salivary bacterial count will be evaluated , then the patient will bbe instructed~     to follow oral hygiene measures including the use of aloe vera toothpaste or fluoride~     toothpaste , the after 15 days and 30 days the patient's salivary bacterial count will be~     evaluated another time.~   "
35012|NCT03108300|"~     Fifty patients with pathological proof of malignant soft tissue sarcoma will receive~     Anthracyclin based chemotherapy combined with propranolol 40 mg twice daily.~        -  The primary end point : To assess Progression Free Survival (PFS)~        -  The secondary end points : To assess Overall Survival (OS) and Toxicity Profile~   "
35013|NCT03108287|"~     This randomized controlled study aimed to evaluate whether adding bismuth to the standard~     first-line triple therapy could improve the eradication rate of Helicobacter pylori (H.~     pylori). A total of 162 patients with H. pylori infection were randomly assigned to either~     the 7-day triple therapy group (n = 81) or the bismuth plus triple therapy group (n = 81).~     The triple therapy (RAK) contained the twice-daily dosage of rabeprazole 20mg, amoxicillin 1g~     and clarithromycin 500mg. In the RBAK group, bismuth subcitrate 360 mg twice daily was added~     to the RAK regimen.~   "
35014|NCT03108274|"~     The purpose of this study is to determine the potential drug interaction between ACH-0144471~     and Midazolam, Fexofenadine and Mycophenolate Mofetil~   "
35015|NCT03108248|"~     For patients with advanced hepatocellular carcinoma (HCC) and portal vein tumor thrombosis~     (PVTT), the survival benefit of transarterial chemoembolization (TACE) remains modest. This~     study aimed to investigate whether TACE in combination with irradiation stent placement (ISP)~     could prolong the survival in patients with HCC and PVTT.~   "
35016|NCT03108235|"~     Aim: To develop a nurse-led, home-based self-management psychosocial education programme,~     entitled HOMe-based HEart Failure Self-Management Programme (HOM-HEMP), and evaluate its~     effects in improving health-related quality of life (HRQoL), psychological well-being,~     self-efficacy, self-care behavior and social support, as well as clinical outcomes among~     older patients with CHF in Singapore.~      Background: The number of elderly people is expected to increase in the coming decades, and~     so too the prevalence of with chronic heart failure (CHF) is expected to increase. Since CHF~     is a chronic condition, there is a need to develop programmes that will improve the quality~     of life of older patients who have to manage this condition for years to come.~      Design: A stratified, three-arm randomised controlled trial (RCT) will be adopted.~      Methodology: The HOM-HEMP is designed a six-week home-based psychosocial education programme~     comprising of a specifically developed HF Tool Kit and a supplementary smartphone app. A~     consecutive sample of 213 older patients with CHF will be recruited from the cardiac ward of~     a tertiary public hospital in Singapore. They will be randomly assigned to the control group,~     or experimental group A (HOM-HEMP without App) or the experimental group B (HOM-HEMP with~     App). A research nurse will be delivering the HOM-HEMP to the participants in the~     experimental groups, while another research assistant who is blinded to participants' group~     assignment will be responsible for data collection. Data will be collected at baseline, at 6~     weeks immediate after the intervention, and at 3 and 6 months from the baseline. At the end~     of the programme, a process evaluation will be conducted to assess the acceptability,~     strengths and weaknesses of the HOM-HEMP based on the participants' perspectives.~      Discussion: It is expected the proposed RCT will make a contribution to knowledge development~     of the effectiveness of the HOM-HEMP and the active ingredients of the programme.~   "
35017|NCT03108222|"~     Chronic kidney disease (CKD) affects approximately 26 million Americans with many more at~     risk for disease development. Elevated serum phosphorus (P) and related abnormalities in P~     homeostasis due to progressive loss of kidney function are primary driving forces behind~     cardiovascular dysfunction and mortality in CKD patients. Intestinal P absorption is an~     critical aspect in P homeostasis but has been understudied, particularly in the early stages~     of CKD progression. This study aims to determine P absorption in patients with moderate CKD~     compared to healthy adults.~   "
35030|NCT03108053|"~     Up-to-date, urology guidelines introduce safety guidewire (SGW) as an integral tool in~     ureteroscopy and recommended its routine use. However, the necessity of SGW placement in~     endourological procedures lack evidence and is being suggested as an expert opinion. Present~     study aimed to evaluate the use of SGW placement and its necessity in treatment of ureteral~     stones with semi-rigid ureteroscopy (s-URS).~      For this purpose patients with ureteral stones are being stratified according to ureteral~     stone location and prospectively randomized into two groups' according to SGW usage or not in~     s-URS. Ureteroscopy and litotripsy is being done with a semi-rigid ureteroscope of 6.4/7.8 Fr~     (Olympus) and laser. Chi-square and student t-test were used for comparing data.~   "
35155|NCT03106428|"~     To assess safety and tolerability, describe the dose-limiting toxicities, determine the~     maximum tolerated dose (MTD) or the highest protocol-defined dose (maximum administered dose)~     in the absence of establishing the MTD, and a recommended dose for further evaluation of~     MEDI7247 in patients with selected hematological malignancies who have relapsed after, or are~     refractory to prior standard therapy, and for whom there is no standard salvage regimen~     available.~   "
35018|NCT03108209|"~     Vemurafenib is an anti-cancer treatment indicated as monotherapy in the treatment of adult~     patients with non-resectable or metastatic melanoma carrying a BRAF V600 mutation.~      Cobimetinib is indicated in combination with Vemurafenib in the treatment of adult patients~     with non-resectable or metastatic melanoma carrying a BRAF V600 mutation.~      These treatments are associated with a lot of adverse reactions, which may lead to dose~     reduction, temporary interruption or discontinuation of treatment, which often leads to~     treatment failure or a decrease in treatment compliance.~      The most commonly reported adverse reactions (> 30%) with Vemurafenib are arthralgia, rash,~     photosensitivity reaction, nausea, alopecia and pruritus. The most commonly reported adverse~     events (> 20%) associated with Cobimetinib / Vemurafenib are diarrhea, rash, nausea, pyrexia,~     photosensitivity reaction, increase of alanine aminotransferase, elevation of aspartate~     aminotransferase, blood creatine phosphokinase elevation and vomiting.~      The risk of presenting a phototoxicity adverse event with Vemurafenib in monotherapy or in~     combination with Cobimetinib is very common (≥ 1/10) according to MedDRA.~      The use of optimal photoprotection including the repeated daily use of external~     photoprotection products is currently recommended for all patients receiving treatment with~     vemurafenib or with the combination of vemurafenib and cobimetinib.~   "
35019|NCT03108196|"~     Bladder cancer is a common malignant tumor of the urinary system, radical resection plus~     urinary diversion is the first choice of treatment for muscle invasive bladder cancer.~     Urinary diversion of surgical options related to patient' survival and quality of life.~      In 1988, Hautmann firstly reported an orthotopic urinary diversion method: Hautmann~     neobladder. As the urine can be controlled from the original urethra, the patient's quality~     of life has been greatly improved, so the new bladder surgery gradually accepted and welcomed~     by urologists and patients. However, in order to achieve low-pressure and large-volume~     storage capacity of the urine reservoir, the 40-70cm long interception of terminal ileum need~     to be detubularized. Only after split, folded, re-stitched and a series of treatment, the~     intestinal can be used. Such complicated procedures make so many urologists give it up. In~     addition, the interception of the long ileum may lead to reduced absorption of vitamin B12~     which caused anemia, metabolic acidosis, intestinal dysfunction. Not only that, as time goes~     by, this kind of neobladder will be unlimited expansion and resulting in a serious increase~     in residual urine volume, hydronephrosis, or even the occurrence of neobladder spontaneous~     rupture.~      In 2000, professor Chunxiao Liu invented detaenial sigmoid neobladder, this surgical method~     overset the traditional intestinal detubularization approach, which detached the serosal~     layer with smooth muscle from the bowel without split it. This kind of neobladder is easier~     to construct and have less impact on intestinal function. So far, it has been implemented for~     more than 600 cases in Zhujiang hospital, the age of patients range from 9 months (bladder~     rhabdomyosarcoma) to 84 years old.~      So far as now, no multicenter prospective clinical study on orthotopic urinary diversion has~     been performed worldwide, neither the head-to-head studies on detaenial sigmoid neobladder~     and ileal neobladder.~      Our project is going to perform a multicenter randomized controlled trial for these two~     neobladder methods and look forward to assess the safety and efficacy of these two procedures~     which provide an objective basis for the patients undergoing orthotopic urinary diversion in~     the future.~   "
35020|NCT03108183|"~     The purpose of the study is to evaluate the longterm treatment results after micro-surgical~     root resection of teeth with post and core and crown.~   "
35021|NCT03108170|"~     Pregnant participants will be recruited at the obstetrics outpatient clinic during their~     visits 4 weeks before the due date. They are randomized into two groups. The first group will~     be educated to do digital perineal massage. They will be also educated to do pelvic floor~     muscle exercises and will receive the usual education program for strengthening the pelvic~     floor. The second group will receive the usual education program for strengthening the pelvic~     floor. Occurrence of perineal laceration will be reported at time of delivery.~   "
35022|NCT03108157|"~     Clinical trial about the effect of endometrial scratch on pregnancy rates in patients~     undergoing a treatment with in-vitro fertilization with donor eggs, when doing the~     endometrial biopsy during the cycle prior to the embryo transfer.~   "
35023|NCT03108144|"~     Tobacco and alcohol use present multiplicative risk for aerodigestive cancers. Reducing~     alcohol consumption improves smoking cessation outcomes and reduces cancer risk. Risky~     alcohol consumption and smoking are often treated separately despite concurrent treatment~     potentially leading to better outcomes for each. However, no rapidly scalable program exists~     for combined interventions in primary care clinics spread across wide geographic areas. This~     cluster randomized trial aims to report on the effects of a novel clinical decision support~     system (CDSS) on intervention rates by primary care practitioners addressing risky alcohol~     use in a smoking cessation program.~      The investigators will be implementing a clinical decision support system (CDSS) in 221~     primary care sites participating in the Smoking Treatment for Ontario Patients (STOP) program~     across Ontario, Canada. Sites will be blindly allocated to one of two clinical decision~     support systems guiding practitioners to provide a risky alcohol use intervention to smokers~     attempting to quit using nicotine replacement therapy (NRT). Risky alcohol use is defined as~     drinking above the Canadian Cancer Society's low-risk drinking guidelines. Primary analysis~     will measure the proportion of risky drinkers offered an alcohol intervention in each CDSS~     arm at baseline. Patients will be contacted by phone or email to track smoking cessation and~     alcohol consumption rates at 6- and 12-month follow up.~      Upon completion of the trial, the effect of different clinical decision support systems on~     practitioner behavior, and on client tobacco and alcohol use, will be discussed. If the CDSS~     successfully promotes SBIRT for risky alcohol use in a primary care setting and/or improves~     patient-level outcomes, including smoking cessation rates and alcohol use reduction, this~     tool can be used as a model for other web-based behavior change interventions integrated into~     primary care practice.~   "
35024|NCT03108131|"~     The goal of this research study is to learn if cobimetinib and atezolizumab can help to~     control advanced rare tumors. The safety of the drugs will also be studied.~      This is an investigational study. Atezolizumab is FDA approved and commercially available for~     the treatment of metastatic (has spread) non-small cell lung cancer (NSCLC). Cobimetinib is~     FDA approved in combination with another drug called vemurafenib for the treatment of~     metastatic melanoma.~      It is investigational to use atezolizumab and cobimetinib to treat advanced rare tumors.~      The study doctor can explain how the study drugs are designed to work.~      Up to 60 participants will be enrolled in this study. All will take part at MD Anderson.~   "
35025|NCT03108118|"~     This study is designed to evaluate the relationship between diaphragm activity during~     mechanical ventilation and the development of ventilator-induced diaphragm dysfunction~     (VIDD). Diaphragm structure, activity, and function are monitored longitudinally over the~     first 7 days of mechanical ventilation.~   "
35026|NCT03108105|"~     The study evaluates the efficacy of a new 2-piece appliance in patients with colostomy.~   "
35027|NCT03108092|"~     The objective of the health economic evaluation is to perform a state-of-the-art economic~     analysis of the STRIP intervention, alongside the OPERAM Randomised Controlled Trial (RCT).~   "
35028|NCT03108079|"~     Demonstrate and compare the 3D morphology of the bladder wall in full and drained states with~     2 different kinds of bladder catheters in place. (Foley Catheter vs. Cystosure Catheter)~   "
35029|NCT03108066|"~     The primary objective of this study is to assess the overall response rate (ORR) of von~     Hippel-Lindau (VHL) disease-associated clear cell renal cell carcinoma (ccRCC) tumors in VHL~     patients treated with PT2385.~   "
48316|NCT02934503|"~     This trial is to assess the efficacy of pembrolizumab added to concurrent chemotherapy with~     or without radiation therapy in patients with small cell lung cancer (SCLC).~   "
35031|NCT03108040|"~     Intrauterine growth restriction (IUGR) is one of the major contributors to perinatal~     mortality and morbidity and is characterized by complex hemodynamic changes involving~     placental and fetal arterial, cardiac and venous circulations .However, the temporal sequence~     of these modifications in relation to other hemodynamic changes of the fetal arterial and~     venous circulations is unknown.~      The aim of this study was to evaluate cardiac function and other hemodynamic changes in a~     group of fetuses with IUGR and clinical impact on perinatal outcome .~   "
35032|NCT03108027|"~     This is a randomized, placebo-controlled, double-blind, six-sequence, three-period cross-over~     study in asthma patients. The study will consist of a 14-day screening period, followed by a~     14-day run-in period, and a treatment epoch which consists of three treatment periods, with a~     minimum duration of 14 days each followed (for the 2 first treatment periods) by a wash-out~     period. The duration of each treatment period may be extended up to a duration of 18 days if~     needed for operational reasons. The third treatment period will be followed by a Study~     Completion evaluation at 1-7 days following the last dose. The treatment periods will be~     separated by wash-out periods of 14 to 21 days duration.~   "
35033|NCT03108014|"~     This study will help us learn more about how early infant diet may influence child's growth~     and development at age 14.~   "
35034|NCT03108001|"~     This study will help us learn more about how a mother's health during pregnancy may influence~     her child's growth and development later in life.~   "
35035|NCT03107988|"~     Lorlatinib is a novel inhibitor across ALK variants, including those resistant to crizotinib.~     In this first pediatric phase 1 trial of lorlatinib, the drug will be utilized as a single~     agent and in combination with chemotherapy in patients with relapsed/refractory~     neuroblastoma. The dose escalation phase of this study (Cohort A1) uses a traditional Phase I~     3+3 design. Once a recommended phase 2 pediatric dose is identified, an expansion cohort of 6~     patients (Cohort B1), within which ALKi naïve patients will be prioritized, will be~     initiated. Parallel cohorts will be initiated in adults or patients with large BSA (Cohort~     A2) and in combination with chemotherapy upon establishing RP2D (Cohort B2).~   "
35036|NCT03107975|"~     This study aimed to evaluate the therapeutic potential of human amniotic epithelial cell~     (hAEC) transplant in the management of children with spastic cerebral palsy.~   "
35037|NCT03107962|"~     The purpose of this study is to evaluate the efficacy and safety of PD-1 blockade~     pembrolizumab for patients with relapsed or refractory Natural Killer(NK)/T Cell Lymphoma.~   "
35038|NCT03107949|"~     An early feasibility study to investigate the safety and feasibility of the Lungpacer~     Diaphragm Pacing Therapy System (DPTS) as a therapy to recondition and strengthen the~     diaphragm of patients who have been intubated and invasively mechanically ventilated for > or~     = 7 days, have failed two or more spontaneous breathing trials (SBT), and were not~     hypervolemic during the latest SBT.~   "
35039|NCT03107936|"~     The goal of the proposed research is multi-step, through a series of sub-studies that build~     on each other as part of a comprehensive line of investigation into the use of interactive~     mobile games as interventions and/or data collection tools around smoking and tobacco~     products in teens.~   "
35040|NCT03107923|"~     This study evaluates whether a preoperative assessment of myocardial contractile reserve by~     tissue Doppler Imaging and myocardial fibrosis by cardiac magnetic resonance imaging (MRI)~     can enhance the patient selection and risk stratification to transcatheter aortic valve~     implantation.~   "
35041|NCT03107910|"~     The alarmingly high rates of HIV/STI (sexually transmitted infections) observed among Black~     men who have sex with men (BMSM) necessitate a new model for engaging BMSM. New approaches~     include addressing stigma related concerns and structural barriers in order to increase~     HIV/STI testing uptake. This research includes a 2 x 2 factorial design to test an~     intervention that is aimed at increasing HIV/STI testing uptake among BMSM; this design~     includes testing HIV/STI stigma focused counseling, and online HIV/STI test counseling with~     at-home, self-administered HIV and STI test kits.~   "
35042|NCT03107897|"~     In this pilot study, investigators aim to identify patients undergoing TAVR who are at~     elevated risk for adverse clinical events due to decreased exertional capacity and physical~     deconditioning. Investigators aim to determine if monitored pre-procedural physical therapy~     is safe in these patients. Lastly, investigators aim to assess the efficacy of~     prehabilitation~        1. to improve physical functioning by the time of TAVR and to sustain benefit through 30~          days post-procedure; and~        2. to determine its effect on post-procedural length-of-stay, clinical outcomes, and~          quality of life.~   "
35043|NCT03107884|"~     Muscle atrophy and insulin resistance are common after bed rest in healthy older adults.~     Metformin treatment has been shown to improve insulin sensitivity and attenuate muscle loss~     in insulin resistance adults though the mechanisms are not fully known. Metformin used as a~     preventive strategy to maintain muscle and metabolic health in bed ridden older adults has~     not been investigated.~   "
35044|NCT03107871|"~     The overall goal of this study is to determine the clinical benefit and safety of antiviral~     therapy for asymptomatic congenital cytomegalovirus (cCMV) infected hearing-impaired infants.~     We will conduct a multi-center double-blind randomized placebo-controlled trial to determine~     whether hearing-impaired infants with asymptomatic cCMV have better hearing and language~     outcomes if they receive valganciclovir antiviral treatment. We will also determine the~     safety of antiviral valganciclovir therapy for asymptomatic cCMV-infected hearing impaired~     infants. This study will be unique in that the cohort enrolled will only include~     hearing-impaired infants with asymptomatic cCMV.~      Aim 1: Test the hypothesis that asymptomatic CMV-infected hearing impaired infants treated~     with antiviral valganciclovir will have better hearing and language outcomes compared with~     untreated CMV-infected hearing impaired infants.~      Aim 2: Evaluate the safety of antiviral valganciclovir therapy for asymptomatic CMV-infected~     hearing impaired infants.~      Aim 3: Evaluate the pharmacokinetics (pK) of valganciclovir using pharmacometrics modeling to~     develop a population pK model.~   "
35094|NCT03107221|"~     A pilot study exploring whether individuals receiving usual treatment (CBT) from the~     specialist NHS Tayside Eating Disorders Service and accessing the online self-help Smart~     Eating programme have improved treatment outcomes compared to those receiving usual~     treatment only. The study will also explore acceptability of the Smart Eating self-help~     programme via a feedback questionnaire.~   "
35045|NCT03107858|"~     Renal transplantation is now recognized as a treatment of choice for patients with chronic~     renal failure with end-stage renal disease. Renal transplantations are associated with better~     quality of life, better cost/benefit ratio, and possibly longer survival. Significant changes~     in blood pressure are common throughout the surgical procedure for kidney transplantation.~     All efforts are made to maintain an appropriate level of blood pressure by using an adequate~     intravascular volume and vasopressor administration. All efforts are made to maintain an~     appropriate level of blood pressure by using an adequate intravascular volume and vasopressor~     administration. All efforts are made to maintain an appropriate level of blood pressure by~     using an adequate intravascular volume and vasopressor administration. All efforts are made~     to maintain an appropriate level of blood pressure by using an adequate intravascular volume~     and vasopressor administration.~   "
35046|NCT03107845|"~     The research project investigates in a randomized controlled trial the effectiveness as well~     as moderating and mediating factors of psychometric feedback to therapists. In the intended~     study a total of 423 patients, who applied for a cognitive-behavioral therapy at the~     psychotherapy clinic of the University Trier and suffer from a depressive and/or an anxiety~     disorder (SCID-interviews), will be included. The patients will be randomly assigned either~     to one therapist as well as to one of two intervention groups (CG, IG2). An additional~     intervention group (IG1) will be generated from an existing archivale data set via propensity~     score matching. Patients of the control group (CG; n = 85) will be monitored concerning~     psychological impairment but therapists will not be provided with any feedback about the~     patients assessments. In both intervention groups (IG1: n = 169; IG2: n = 169) the therapists~     are provided with feedback about the patients self-evaluation in a computerized feedback~     portal. Therapists of the IG2 will additionally be provided with clinical support tools,~     which will be developed in this project, on the basis of existing systems. Therapists will~     also be provided with a personalized treatment recommendation based on similar patients~     (Nearest Neighbors) at the beginning of treatment.~      Besides the general effectiveness of feedback and the clinical support tools for negatively~     developing patients, further mediating and moderating variables on this feedback effect~     should be examined: treatment length, frequency of feedback use, therapist effects,~     therapist's experience, attitude towards feedback as well as congruence of therapist's and~     patient's evaluation concerning the progress.~      Additional procedures will be implemented to assess treatment adherence as well as the~     reliability of diagnosis and to include it into the analyses.~   "
35047|NCT03107832|"~     CONTEXT AND AIMS: The aim of the study is to compare patients satisfaction of thoracic~     epidural and general anesthesia procedures in patients undergoing elective laparoscopic~     cholecystectomy. SETTINGS AND DESIGN: This comparative randomized study was conducted Abant~     Izzet Baysal University hospital between October 2012 and 2014.Forty-five patients who were~     under American Society of Anesthesiologists I-II classification and were scheduled for~     elective laparoscopic cholecystectomy were included in the study. SUBJECTS AND METHODS: All~     participant was separated, two group. In epidural anesthesia group(Group E), a catheter was~     installed and received 20 mg lidocaine hydrochloride, 15 mg bupivacaine, and 25 mg fentanyl~     citrate adjusted to 10 cc with normal saline to be injected by the epidural catheter.~     Bispectral index -controlled sedation was provided. In general anesthesia group(Group G), and~     induction was managed using 1.5 mg/kg fentanyl and 2 mg/kg propofol; 0.5 mg/kg rocuronium and~     sevoflurane in a 50% oxygen/air mixture was used. Blood gas analysis monitoring was performed~     in the 30th minute before and after pneumoperitoneum. Surgical satisfaction was recorded~     after pneumoperitoneum. After the operation, 75 mg diclofenac sodium was applied for patients~     with Numeric Rating Scale scores higher than 4. STATISTICAL ANALYSIS USED:Data analysis was~     performed using the Statistical Package for the Social Sciences version 18 software (SPSS,~     Chicago, IL, US). Descriptive variables, such as age, ASA classification, weight, height,~     mean arterial pressure (MAP), HR, and duration of surgery, are given as mean ± standard~     deviation, and an independent sample t-test (normal distribution) as well as a Mann-Whitney U~     test (not a normal distribution) were used for continuous variables. To compare the normal~     and abnormal distributions in the groups, simple t-test, and Wilcoxon test was used,~     respectively. The results were considered statistically significant at p-values <0.05.~   "
35048|NCT03107819|"~     The investigators are seeking to enroll 8 children ages 2-18 already undergoing upper~     endoscopy. For the purposes of research, a peripheral blood and clean catch urine specimen~     will be obtained to measure plasma and urine metabolomics. The data will be used to determine~     if there are any key differences in the metabolite profile of subjects found to have~     eosinophilic esophagitis (EoE) versus non-EoE subjects. Once these metabolites are~     identified, the investigators will seek to enroll many more subjects for a validation phase.~   "
35049|NCT03107806|"~     To evaluate the OptiScanner® for continuous glucose monitoring as a tool to optimize glucose~     levels in patients hospitalized for acute coronary syndromes~   "
35050|NCT03107793|"~     The purpose of this study is to evaluate the efficacy of a treat to target strategy coupled~     with early endoscopic assessment versus a clinically driven (routine care) approach in~     achieving endoscopic response.~   "
35051|NCT03107780|"~     This phase 0/I trial studies the side effects and best dose of MDM2 inhibitor AMG-232 in~     treating patients with glioblastoma that is newly diagnosed or has come back. MDM2 inhibitor~     AMG-232 may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth.~   "
35052|NCT03107767|"~     There is a high incidence of re-operations after surgery for ankle fractures. According to~     the Danish Fracture Database (DFDB) the re-operation rate, excluding hardware removal, is~     almost 10%.~      We are conducting a study on the efficacy of an evidence based algorithm for the treatment of~     ankle fractures.~   "
35053|NCT03107754|"~     For pain relief during a first trimester surgical aspiration, most providers use the~     paracervical block, either alone or in combination with other pain control techniques. Some~     providers use buffered lidocaine due to a belief that it decreases pain. Others use plain~     lidocaine. At our clinics, the standard pain management protocol is using 20 cc of 1% plain~     lidocaine in a two site injection. Few studies have compared buffered versus unbuffered~     lidocaine for paracervical blocks during first trimester uterine aspirations. This study~     seeks to determine if buffered lidocaine decreases injection pain versus plain lidocaine for~     paracervical blocks.~   "
35054|NCT03107741|"~     Metabolic syndrome (MetS) is a serious public health problem in Hong Kong and worldwide.~     Older adults, the age group with the highest prevalence of MetS, may prefer specific exercise~     modalities that are suitable for their regular participation to manage MetS. This project~     aims to evaluate the effectiveness of Tai Chi, a very suitable exercise for older adults, to~     alleviate MetS in older population~   "
35055|NCT03107728|"~     The purpose of the IM ABLE(Injuries Managed with Advanced Bracing for Lower Extremities)~     study is to determine if advanced (ADV) ankle foot orthoses (AFOs) will enable users to~     achieve greater levels of physical and self-reported function compared with conventional~     (CONV) AFOs for those ambulating at or above the independent community level of ambulation.~   "
35128|NCT03106779|"~     The purpose of this pivotal study is to compare the efficacy of ABL001 with that of bosutinib~     in the treatment of patients with CML-CP having previously been treated with a minimum of two~     prior ATP-binding site TKIs with BCR-ABL ratios ≥ 1% IS at screening.~   "
35056|NCT03107715|"~     Background: Exclusive breastfeeding through age 6 months is the optimal infant feeding method~     due to lifesaving benefits for children and mothers (AAP, others). Exclusive breastfeeding~     in-hospital is critical because in-hospital formula supplementation doubles risk of~     non-exclusive breastfeeding at 30-60 days (Chantry et al, 2014). While breastfeeding~     initiation rates have increased at our inner-city Baby Friendly - designated maternity~     hospital, exclusive breastfeeding lags. CDC mPINC data (maternity practices in infant~     nutrition and care, 2015) demonstrate this is a national problem, with >50% of surveyed~     hospitals endorsing supplementation of 10-49% of breastfed infants.~      Study Objective: The study objective is to evaluate acceptance/satisfaction of 2 prenatal~     interventions (breastfeeding champion and positive messaging) and to determine if these~     affect exclusive breastfeeding intention and practice.~      Methods: In this prospective intervention study with follow-up chart review, we will pilot~     two 5-minute-long iPad-based interventions for 1 month each in obstetrical clinics, following~     a required 28-week obstetrical visit breastfeeding education. All expectant mothers~     (including 14-17 year olds with guardian) are eligible. Outcomes are acceptance (enrollment~     rate), satisfaction (Likert-based), impact on exclusive breastfeeding intention (pre/post~     query) and secondarily impact on exclusive breastfeeding in-hospital and at 2 weeks.~   "
35057|NCT03107702|"~     Bariatric surgical procedures are associated with low short-term mortality and may be~     associated with long-term reductions in all-cause, cardiovascular, and cancer-related~     mortality. This surgeries are major surgeries include risk of mortality still.~      Melatonin is a hormone secreted from the pineal gland. Melatonin is an antioxidant,~     antinociceptive, hypnotic, anticonvulsant, neuroprotective, anxiolytic, sedative and~     analgesic. Melatonin is neurohormone with the profile of a novel hypnotic-anesthetic agent.~      The purpose of this study is to investigate the preoperative, perioperative and postoperative~     melatonin levels in bariatric surgery under general anesthesia and to investigate the~     relationship between melatonin level and analgesia requirement.~   "
35058|NCT03107689|"~     The purpose of this project is to evaluate the case characteristics of patients who receive~     intravenous lipid emulsion therapy. Previous literature to date has focused on animal studies~     or has been primarily limited to case reports or small case series. This prospectively~     collected data set will permit a much more detailed description of the use of lipid, its~     potential benefits, and potential harms.~   "
35059|NCT03107676|"~     College students from physical therapy department will be assigned into four groups.~     Participants will be tested for trunk extensors endurance and will be given endurance~     training program to do at home for 6 to 8 weeks. Spinal mobility and lower extremity mobility~     will be measured. Isokinetic outcome measures for extension and flexion at two different~     speeds will also be measured at baseline, after 6 and 8 weeks.~   "
35060|NCT03107663|"~     The purpose of the study is to determine the safety and tolerability of ⁸⁹Zr-Df-IAB22M2C as~     an immunoPET tracer; determine the best time window and protein dose for imaging; determine~     the determine the dosimetry and biodistribution of ⁸⁹Zr-Df-IAB22M2C.~   "
35061|NCT03107650|"~     Elaboration of a preoperative prediction model of the quality of the mesorectum and the~     involvement of the circumferential margin in patients with mid-low rectal cancer who undergo~     laparoscopic anterior rectal resection.~      In a second phase the investigators will study the utility of the prediction model in~     classifying patients with high risk of suboptimal quality of mesorectum and/or positive~     circumferential margin. Patients with high preoperative risk will undergo a transanal total~     mesorectal excision and patients with low risk a laparoscopic transabdominal mesorectal~     excision. The investigators finally will compare pathological outcomes ( quality of~     mesorectum and circumferential margin), survival and recurrence between the two groups.~   "
35062|NCT03107637|"~     The ESUS concept was introduced recently to describe a non-lacunar stroke of undetermined~     etiology. The following etiological workup is required in this setting: head CT or MRI,~     12-lead ECG, transthoracic echocardiography, continuous cardiac monitoring for at least 24~     hours after stroke, vascular imaging (ultrasound, magnetic resonance angiography, CT~     angiography, catheter angiography). Transesophageal echocardiography (TEE) is considered not~     to be required.~      However, aortic arch atheroma as diagnosed by TEE in the setting of recent ischemic stroke is~     a major aortic source of embolism, as supported by numerous well conducted studies. The~     European Association of Echocardiography considers that TEE is the gold standard for the~     diagnosis and the characterization of aortic atheroma. It is also the method of choice for~     the diagnosis of infectious endocarditis.~      The aim of this work was to evaluate the rate of patients with a therapeutic modification~     induced by TEE (mainly anticoagulation and surgery), in consecutive patients admitted with~     ESUS at our institution stroke unit.~   "
35063|NCT03107624|"~     This study aimed to evaluate the incidence of preinfarction angina in AMI patients and test~     the hypothesis that different clinical presentations before AMI onset can affect coronary~     plaque morphologies in AMI patients .~   "
35064|NCT03107611|"~     To establish the bioequivalence between test drug, Pimecrolimus Cream, 1% with that of~     reference listed drug, Elidel® (pimecrolimus) Cream 1%, in the treatment of mild to moderate~     Atopic Dermatitis.~      To establish superiority of each active treatment over the placebo.~   "
35065|NCT03107598|"~     Comparison between colloid preload and crystalloid co-load in cesarean section under spinal~     anesthesia.~        1. The primary outcome was the incidence of hypotension~        2. Secondary outcomes included the incidence of severe hypotension, total ephedrine dose,~          nausea and vomiting and neonatal outcome assessed by Apgar scores and umbilical artery~          blood gas analysis~   "
35066|NCT03107585|"~     The investigators included prospectively 35 patients undergoing an intermediate cervical~     block under ultrasound (GP1) before a thyroidectomy ,compared to a group of 35 patients~     without a block (GP2).~   "
35067|NCT03107572|"~     The study consist of evaluation in cardiac surgery with cardiopulmonary bypass (CPB) setting~     the ability of PCO2 derived variables (ΔPCO2, ΔPCO2/C(a-v)O2 ratio), compared to lactate and~     ScVO2 to predict major postoperative adverse events.~   "
35068|NCT03107559|"~     It can be suggested that sympathetic tonus increase and pain, caused by the removal of the~     effect of epidural analgesia applied at birth, may also affect perfüsion index. The purpose~     of this study is; To correlate the VAS value at the time of return of epidural analgesia with~     the PI values at that time and, to test the possibility of using PI variants as an objective~     tool for predicting pain initiation time and assessing pain.~   "
35069|NCT03107546|"~     Syndactyly is the most common hand abnormality in children. During development, two or more~     fingers do not separate in the usual way and remain connected by skin. Surgery is needed to~     separate the fingers. Usually, it is performed between 6 months and 3 years of age, depending~     on the severity of the syndactyly. During the surgery, the fingers are separated; however,~     there isn't enough skin to completely cover the fingers once they are separated. There are~     two areas on the fingers that need to be covered after separation, and there is a standard~     method, and now a new technique to cover these areas.~      The standard current technique that surgeons use to cover the newly separated fingers is to~     apply a small section of the patient's own skin taken from a different area of their body~     (this is known as a skin graft).~      A new technique called Hyaluronic acid matrix (Hyalomatrix®) is a U.S. Food and Drug~     Administration (FDA) approved, commercially available, skin graft substitute that is~     currently being used both in the US and in Europe. The Hyalomatrix (or skin graft substitute)~     is sutured into place using a stitch on each corner, over the areas left without skin~     covering during the surgery.~      The purpose of this study is to compare effectiveness, wound healing, scar formation and~     potential associated complications of the current skin graft technique with the new technique~     called Hyalomatrix (or skin graft substitute) following surgery.~   "
35070|NCT03107533|"~     Analysis of video encounters between providers, patients, and families will be used to~     develop a shared decision making tool for patients deciding between surgery and observation~     for scoliosis treatment.~   "
35071|NCT03107520|"~     This study evaluates the feasibility and utility of contrast-enhanced ultrasound to provide~     real-time assessment of blood flow to the femoral head in infants undergoing surgical~     reduction for developmental dysplasia of the hip.~   "
35072|NCT03107507|"~     Over the last three decades, several tools have been developed to enhance the detection and~     treatment of neonatal seizures. Regarding treatment, phenobarbital maintains is still used as~     a first-line therapy worldwide. However, newer anti-epileptic drugs (AED) s such as,~     levetiracetam, bumetanide, and topiramate are increasingly being applied to the neonatal~     population, offering the potential for seizure treatment with a significantly better~     side-effect profile.~      Levetiracetam is a very promising medication for the treatment of neonatal seizures. It has~     been in clinical use for almost a decade in adults and older children with good efficacy, an~     excellent safety profile and near ideal pharmacokinetic characteristics. It has been approved~     and used for treatment of seizures in infants starting one month of age since 2012.~      The investigators are comparing the efficacy of levetiracetam to that of phenobarbital as a~     first-line drug in control of neonatal seizures. The investigators monitor the efficacy~     through assessment of frequency of seizures before and after drug administration, amplitude~     integrated EEG changes in background activity and seizure frequency in participants, duration~     taken for participants to be seizure free and short term neurodevelopmental outcome and EEG~     at 3 months of age~   "
35073|NCT03107494|"~     Feasibility trial (FIH) to assess the safety and clinical utility in patients with chronic~     bronchitis.~   "
35074|NCT03107481|"~     The purpose of the current study is to compare the analgesic efficacy of intravenous~     acetaminophen and intravenous hydromorphone in the treatment of acute pain in the ED.~   "
35075|NCT03107468|"~     This is a clinical trial for evaluating the safety and effectiveness of the Mokhuri intensive~     treatment program regarding pain and function before and after treatment between a group~     receiving the Mokhuri intensive treatment program (Chuna, acupuncture, and patient education)~     for five weeks and another group receiving non-surgical conventional standard treatment~     (drugs for pain relief, epidural steroid injection treatment, and physical therapy).~      The trial will be conducted through international cooperation between Mayo Clinic in the~     United States and Mokhuri Oriental Medicine Hospital in Korea. All subjects in Korea and the~     US will be selected based on the same inclusion criteria and exclusion criteria. All subjects~     in the treatment arm will receive the same treatment in Korea and the US. In collaboration~     and with the support of Mayo Clinic's Department of Integrative Medicine and Health, and to~     ensure treatment consistency between Korea and the US, an acupuncturist from the USA will~     travel to Korea and train on-site for one month in Mokhuri hospital.~      The trial subjects who agree to participate in the clinical trial after providing informed~     consent will receive the required examinations and tests according to the clinical trial~     plan. If they are appropriate for this clinical trial and eligible based on the Inclusion and~     exclusion criteria, they will be randomly assigned to the group that will undergo the focused~     Mokhuri intensive treatment program and to the group that will receive non-surgical~     conventional treatment on their second visit. All the subjects in this study will be educated~     regarding the study procedure and scheduled visits and will participate in the allocated~     treatments for five weeks. Afterwards, clinical outcomes of both groups will be evaluated~     after end of the treatments from between a week and five weeks (within +7 days). The clinical~     trial ends after the follow-up evaluations that will take place 12 weeks, 24 weeks, 48 weeks,~     and 96 weeks after the end of the treatment evaluation.~   "
35076|NCT03107455|"~     Acute MR may develop in the setting of an acute myocardial infarction (AMI) as a result of~     papillary muscle dysfunction or rupture, and these patients are grossly underrepresented in~     MitraClip registries. Our group has recently published the Spanish experience with MitraClip~     in acute MI, but only 5 patients could be collected. However, the results of our initial~     experience are highly encouraging since patients performed well in such life-threatening~     condition. In order to expand the information of the device in this condition, our aim is to~     start a multinational registry in Europe.~   "
35077|NCT03107442|"~     Patients with Systemic Lupus Erythematosus (SLE) have increased arterial stiffness, which~     leads to cardiovascular diseases (CVD) of arteriosclerotic origin, which are the main cause~     of mortality in these patients. Exercise is a modifiable factor that reduces cardiovascular~     mortality and associated risk factors in the general population. Preliminary studies suggest~     that exercise may improve endothelial function and lipid profile in patients with SLE.~     However, whether meeting the international physical activity guidelines from the American~     College of Sports Medicine (ACSM; i.e. ≥150 min / week of moderate to vigorous intensity~     physical activity) can improve arterial stiffness (subclinical atherosclerosis marker) and~     inflammation is unknown.~      The primary aim of this study is to assess the effect of an exercise program based on meeting~     the ACSM physical activity guidelines on arterial stiffness and inflammation in patients with~     SLE.~      The secondary aim is to assess the effect of an exercise program based on meeting the ACSM~     physical activity guidelines on endothelial function, oxidative stress, as well as other~     cardiometabolic risk factors, physical fitness, health-related quality of life, and other~     psychosocial outcomes.~      Our hypothesis is that meeting the ACSM guidelines will improve arterial stiffness and~     inflammation in patients with SLE.~      The study is a non-randomized clinical trial. To minimize selection bias, participants in the~     intervention and control groups will be matched by age, BMI, and disease activity (SLEDAI),~     which are important contributors to arterial stiffness.~   "
35710|NCT03099187|"~     The purpose of this study is to evaluate the efficacy and safety of pirfenidone in~     participants with fibrosing interstitial lung disease (ILD) who cannot be classified with~     moderate or high confidence into any other category of fibrosing ILD by multidisciplinary~     team (MDT) review (unclassifiable ILD).~   "
35078|NCT03107429|"~     Perioperative vision loss following laparoscopic colorectal surgery is rare but has been~     reported. Studies show Trendelenburg positioning during surgery can produce a significant~     rise in the IOP, and this rise is thought to be a possible factor. Acetazolamide decreases~     IOP by reducing the formation of aqueous humour.~      Aims:~      To investigate if acetazolamide reduces the IOP rise resulting from Trendelenburg~     positioning.~      Methods:~      A randomised cross-over blinded pilot study. Nine healthy volunteers were randomised to start~     with the placebo or Acetazolamide with a 5 days' washout period. Baseline IOP was measured on~     both days. After 1.5 hours of taking the medication, volunteers lay head-down at 17 degrees'~     for 4 hours and IOP measurements repeated. This reading was subtracted from the baseline to~     give a 'change in IOP'.~   "
35079|NCT03107416|"~     The purpose of this study is to test the safety of Bumetanide , at different doses to find~     out what effects, if any, it has on people who undergo tumor TAE as part of their regular~     care. Bumetanide is a commonly used medication to reduce the amount of water in the body.~   "
35080|NCT03107403|"~     The aim of the study is to investigate a possible role of dreaming in emotion regulation~     testing whether dreaming of a close relative recently deceased is correlated with a positive~     evolution of the bereavement process~   "
35081|NCT03107390|"~     NT-proBNP is a major diagnostic and prognostic marker in cardiology, but it is also a new~     marker for biological inflammation, especially in rheumatology.~      Its evaluation in chronic inflammatory bowel disease was carried out in a preliminary study,~     the OPERA study where in a population of 12 patients showed an increase in NT-proBNP~     correlated with the biological and endoscopic activity of the disease. This larger study is~     therefore a pilot study that could see NTproBNP as a new biomarker of inflammation in MICI.~   "
35082|NCT03107377|"~     Phase 2B double-blind placebo-controlled efficacy trial of Amphora® gel for the prevention of~     acquisition of urogenital Chlamydia trachomatis infection~   "
35083|NCT03107364|"~     Medical and surgical innovations have allowed to shorter length of hospital stay (LOS). We~     assume that hospitals with uncontrolled reduction in LOS may expose patients to unsafe care.~     At the institutional level, a dynamic analysis of LOS evolution over time could clarify the~     existence of a link with the risk of readmission.~   "
35084|NCT03107351|"~     This study aims to validate the possibility to track cardiac contractility changes with a new~     technology called 'Heart Kinetic' (HK). HK measurements will be realized and compared~     echocardiography.~   "
35085|NCT03107338|"~     The objective of this prospective randomized double-blind study was to evaluate the effects~     of the preoperative administration of dexketoprofen trometamol (DKT) on the pain perceived by~     patients after oral surgery for implant placement.~      Materials and Method: Single oral doses of 25 mg DKT or PLACEBO were administered 15 minutes~     before the performance of conventional implant surgery to assess the influence of the DKT on~     pain as reported by the patients. One hundred patients who required single-implant treatments~     were randomly distributed into one of the two blinded groups following a preliminary~     examination. Fifteen minutes before surgery, the patients in the test group were given 25 mg~     DKT (DKT group), and those in the control group were given 500 mg vitamin C as a placebo~     (PLACEBO group). The patients' pain intensities were measured using a subjective visual~     analogue scale of 100 mm in length, and pain was measured over a period of 7 days.~     Inflammation was assessed using a 5-point Likert scale on days 2 and 7.~   "
35086|NCT03107325|"~     The radiation exposure resulting from medical imaging is a topic of some concern. Nuclear~     medicine provides potentially life-saving information regarding physiological processes, and~     is of particular value in children where the rapid and unequivocal diagnosis of pathological~     concerns is essential for the health of these patients. The overall objective of this~     investigation is to optimize pediatric patient absorbed dose by keeping it as low as possible~     while maintaining excellent diagnostic quality of nuclear medicine images. This is~     particularly important since children are at increased risk due to the enhanced~     radiosensitivity of their tissues and the longer time-period over which radiation effects may~     manifest. Current dosimetric estimations in children are based on either animal biokinetic or~     pharmacokinetic data from adults due to paucity of data that exists for children. This~     situation will be improved through the following specific aims:~        -  Collect image-based pharmacokinetic (PK) data from patient volunteers in different age~          groups scheduled for routine nuclear medicine studies for F-18 fluorodeoxyglucose (FDG),~          a radiopharmaceutical commonly used in pediatric nuclear medicine~        -  Pool and analyze the data for different age groups for each radiopharmaceuticals and~        -  Generate biokinetic models to be used in subsequent dosimetric models for the~          optimization of pediatric nuclear medicine procedures.~      Since inadequate pharmacokinetic data currently exist in these patients, the investigators~     will use the data acquired in this study to establish PK models applicable to different age~     categories. Data on the pharmacokinetics of agents used in pediatric nuclear medicine are~     almost completely lacking. Internationally adopted dose coefficients (mSv/MBq) for pediatric~     nuclear medicine make age-dependent adjustments only for patient size and anatomical~     differences, while time-dependent kinetics from adult PK models are assumed due to the lack~     of kinetic data for children. The data obtained from this study will make it possible for the~     first time to determine how the PK in pediatric patients differs from adults. This will be~     done for F-18 fluorodeoxyglucose (FDG), a radiopharmaceutical commonly used for pediatric~     nuclear medicine imaging. The overall hope is that results will allow the molecular imaging~     community to implement pediatric dose-reduction approaches that substantially improve upon~     current guidelines pointing to future technological advances that could yield even greater~     dose-reduction while simultaneously improving diagnostic image quality.~   "
35087|NCT03107312|"~     Recent observations in Germany revealed above-average high proportions of refugees affected~     by infectious diseases of public health significance. Scrutiny of the vaccination status~     showed sizeable presence of seronegative subjects, with conspicuously higher prevalence among~     children and adolescents, thus indicating urgent necessity of i) rapid identification of~     carriers of vaccine-preventable diseases and ii) adjustment of protection against such~     infections to European Standards. Rapid immune status check needs comprehensive diagnostic~     tool permitting simultaneous assessment of seropositivity. Validation of such tools requires~     comparisons of the immune status of subjects with known vaccination history with that of~     migrants with incomplete or missing health and vaccination records.~   "
35088|NCT03107299|"~     Methotrexate (MTX) is the first-line treatment for rheumatoid arthritis (RA). Poor adherence~     of this treatment decreases the control of the disease and the effectiveness of the~     associated treatments.~      The aim would be to study the observance of patients with RA and to be able to propose~     adequate solutions favoring patient compliance and thus the stability of the pathology.~      For this purpose, 3 methods of communication have been put in place to encourage adherence:~     usual care by the rheumatologist, sms sending or pharmaceutical maintenance.~   "
35129|NCT03106766|"~     To assess facial acne vulgaris clinical and psychological outcomes by measuring differences~     in lesions counts, investigator global assessment, and subjects quality of life scores over 6~     months in adult females treated with Next Science™ acne cream 2x or Next Science™ acne cream~     1x in a double blind manner.~   "
35736|NCT03098849|"~     The purpose of this study is to investigate the effects of a Buteyko-based breathing~     technique on physiological and psychological parameters in adults with asthma~   "
35089|NCT03107286|"~     The radiation exposure resulting from medical imaging is a topic of some concern. Nuclear~     medicine provides potentially life-saving information regarding physiological processes, and~     is of particular value in children where the rapid and unequivocal diagnosis of pathological~     concerns is essential for the health of these patients. The overall objective of this~     investigation is to optimize pediatric patient absorbed dose by keeping it as low as possible~     while maintaining excellent diagnostic quality of nuclear medicine images. This is~     particularly important since children are at increased risk due to the enhanced~     radiosensitivity of their tissues and the longer time-period over which radiation effects may~     manifest. Current dosimetric estimations in children are based on either animal biokinetic or~     pharmacokinetic data from adults due to paucity of data that exists for children. This~     situation will be improved through the following specific aims:~        -  Collect image-based pharmacokinetic (PK) data from patient volunteers in different age~          groups scheduled for routine nuclear medicine studies for Tc-99m~          mercaptoacetyltriglycine (MAG3), a radiopharmaceutical commonly used in pediatric~          nuclear medicine~        -  Pool and analyze the data for different age groups for each radiopharmaceuticals and~        -  Generate biokinetic models to be used in subsequent dosimetric models for the~          optimization of pediatric nuclear medicine procedures.~      Since inadequate pharmacokinetic data currently exist in these patients, the investigators~     will use the data acquired in this study to establish PK models applicable to different age~     categories. Data on the pharmacokinetics of agents used in pediatric nuclear medicine are~     almost completely lacking. Internationally adopted dose coefficients (mSv/MBq) for pediatric~     nuclear medicine make age-dependent adjustments only for patient size and anatomical~     differences, while time-dependent kinetics from adult PK models are assumed due to the lack~     of kinetic data for children. The data obtained from this study will make it possible for the~     first time to determine how the PK in pediatric patients differs from adults. This will be~     done for Tc-99m MAG3, a radiopharmaceutical commonly used for pediatric nuclear medicine~     imaging. The overall hope is that results will allow the molecular imaging community to~     implement pediatric dose-reduction approaches that substantially improve upon current~     guidelines pointing to future technological advances that could yield even greater~     dose-reduction while simultaneously improving diagnostic image quality.~   "
35090|NCT03107273|"~     Myelodysplastic syndromes (MDS) are myeloid hemopathies characterized by ineffective clonal~     haematopoiesis, peripheral cytopenias and a predisposition to the occurrence of acute myeloid~     leukemias. Their diagnosis involves a cytological evaluation of the medulla, while their~     prognosis, in addition to extrinsic factors depending on the patient himself (age,~     comorbidities), intrinsic factors. The cytological evaluation is subject to a certain~     subjectivity since qualitative and the diagnosis is sometimes difficult in the absence of~     marker of clonality. More and more studies emphasize the interest of flow cytometry (CMF) in~     the diagnosis of SMD: by looking for qualitative and / or quantitative aberrations of the~     expression of membrane markers, CMF allows to establish scores Diagnosis that we have put in~     place within the laboratory. However, these studies are based on a static model that studies~     the phenotypic characteristics of patients at a given time but does not really reflect~     ineffective hematopoiesis. A dynamic model for in vitro reproduction of hematopoiesis would~     be an innovative tool for the study of SMD. This project aims to develop and standardize a~     system of differentiation in liquid medium of hematopoietic stem cells (CSH) in mature cells~     by studying each stage of the differentiation in terms of proliferation, apoptosis and~     phenotypic expression. HSCs will be obtained by CD34 + sorting from the medullary sample at~     diagnosis: the investigator will study cell proliferation, apoptosis and the acquisition of~     surface markers, in order to identify the quantitative and qualitative abnormalities~     associated with the differentiation of haematopoietic progenitors Smart. This should make it~     possible to identify diagnostic and prognostic factors in terms of response to treatment,~     acutism and survival.~   "
35091|NCT03107260|"~     There is no study of the association between ScO2 and POCD in non-cardiac, thoracic or~     vascular surgery. The few studies found in cardiac, thoracic and vascular surgery show an~     incidence up to 50% with a variation of the ScO2 threshold which varies between 15 and 25%~     according to the studies.~      Age is the main risk of OCDD. The management of this pathology should be early to avoid loss~     of autonomy of the patient. Finding a relationship, if it exists, would therefore~     significantly improve the mortality and morbidity of the said patient.~   "
35092|NCT03107247|"~     The radiation exposure resulting from medical imaging is a topic of some concern. Nuclear~     medicine provides potentially life-saving information regarding physiological processes, and~     is of particular value in children where the rapid and unequivocal diagnosis of pathological~     concerns is essential for the health of these patients. The overall objective of this~     investigation is to optimize pediatric patient absorbed dose by keeping it as low as possible~     while maintaining excellent diagnostic quality of nuclear medicine images. This is~     particularly important since children are at increased risk due to the enhanced~     radiosensitivity of their tissues and the longer time-period over which radiation effects may~     manifest. Current dosimetric estimations in children are based on either animal biokinetic or~     pharmacokinetic data from adults due to paucity of data that exists for children. This~     situation will be improved through the following specific aims:~        -  Collect image-based pharmacokinetic (PK) data from patient volunteers in different age~          groups scheduled for routine nuclear medicine studies for Tc-99m methylene diphosphonate~          (MDP), a radiopharmaceutical commonly used in pediatric nuclear medicine~        -  Pool and analyze the data for different age groups for each radiopharmaceuticals and~        -  Generate biokinetic models to be used in subsequent dosimetric models for the~          optimization of pediatric nuclear medicine procedures.~      Since inadequate pharmacokinetic data currently exist in these patients, the investigators~     will use the data acquired in this study to establish PK models applicable to different age~     categories. Data on the pharmacokinetics of agents used in pediatric nuclear medicine are~     almost completely lacking. Internationally adopted dose coefficients (mSv/MBq) for pediatric~     nuclear medicine make age-dependent adjustments only for patient size and anatomical~     differences, while time-dependent kinetics from adult PK models are assumed due to the lack~     of kinetic data for children. The data obtained from this study will make it possible for the~     first time to determine how the PK in pediatric patients differs from adults. This will be~     done for Tc-99m MDP, a radiopharmaceutical commonly used for pediatric nuclear medicine~     imaging. The overall hope is that results will allow the molecular imaging community to~     implement pediatric dose-reduction approaches that substantially improve upon current~     guidelines pointing to future technological advances that could yield even greater~     dose-reduction while simultaneously improving diagnostic image quality.~   "
35093|NCT03107234|"~     Breast cancer is the leading cause of female cancer and female death by cancer in France.~     Despite the improvement in early detection and therapeutic arsenal, the mortality of this~     cancer remains high with 11 886 deaths estimated in 2012. Breast cancer is most often a~     carcinoma born from the lobular or ductal epithelium and is classified In two main~     categories: non invasive and invasive. Invasive breast cancers account for 75% of the cases.~     They are usually ductal (75%) and more rarely lobular (25%). The cancer cells are then no~     longer circumscribed to the galactophoric canals or glands but have invaded neighboring~     tissues. If they are not treated in time, these cancers can then spread: the cancerous cells~     will then migrate either by the lymphatic vessels to reach the neighboring ganglia or through~     the blood vessels to give metastases in other tissues In the liver, lungs and bones). The~     mortality associated with breast cancer is not due to the growth of the primary tumor but~     rather to the occurrence of metastases. The study of the mechanisms leading to metastatic~     invasion (i.e. migration and invasion) is therefore of considerable importance. The~     development of metastases depends on the acquisition by the cancer cells of various~     capacities including that of being able to migrate, involving a remodeling of the~     cytoskeleton highly dependent on the intracellular calcium (Ca2 +) concentration. Several~     types of signals are able to induce mobilization of Ca2 + from the extracellular medium or~     endoplasmic reticulum (ER) reserves. At the intracellular level, some of these signals are~     generated by inositol (1,4,5) -trisphosphate (IP3) from the activation of G protein-coupled~     receptors or certain receptors with tyrosine kinase activity. Has been shown that the~     expression, activity and regulation of IP3R receptors (IP3Rs) are involved in the cancerous~     processes of many tissues, in particular in the phenomena of proliferation of breast cancer~     cells. Overall, altered expression and / or activity of IP3Rs can be used for the survival,~     growth, proliferation and migration of cancer cells.~      In the laboratory, the investigator showed that regulation of the expression of subtype 3~     (IP3R3) by 17β-estradiol (E2) is involved in the growth of the human mammary cancer line~     MCF-7. E2 triggers the release of Ca2 + in an IP3-dependent mechanism, while prolonged~     exposure to E2 leads to an increase in the expression of IP3R3. At the same time, the~     reduction in the expression of IP3R3 cancels the proliferative effect of E2 on MCF-7 cells.~     More recently, the investigator has established that IP3R3 regulates the proliferation of~     cells of the human MCF-7 mammary cancer cell line via a molecular and functional interaction~     with the Ca2 + -dependent BKCa potassium channel. The determination of IP3Rs, including~     subtype 3, as a mediator / marker of breast carcinogenesis appears to be a major clinical~     issue.~   "
35095|NCT03107208|"~     A frequent complication in the management of diabetic ketoacidosis (DKA) in children with~     type 1 diabetes is rebound hyperglycemia (blood glucose over 180 mg/dL) which increases the~     risk of re-developing DKA and can lengthen the hospital stay. The investigators want to study~     whether giving the long-acting insulin glargine (Lantus®) early in DKA management (versus~     after complete resolution of the DKA) helps prevent rebound hyperglycemia and makes the~     transition to insulin injections easier. Participants will also have the option to wear a~     continuous glucose monitor (CGM) during the study to help us understand blood glucose control~     during and after DKA.~   "
35096|NCT03107195|"~     The radiation exposure resulting from medical imaging is a topic of some concern. Nuclear~     medicine provides potentially life-saving information regarding physiological processes, and~     is of particular value in children where the rapid and unequivocal diagnosis of pathological~     concerns is essential for the health of these patients. The overall objective of this~     investigation is to optimize pediatric patient absorbed dose by keeping it as low as possible~     while maintaining excellent diagnostic quality of nuclear medicine images. This is~     particularly important since children are at increased risk due to the enhanced~     radiosensitivity of their tissues and the longer time-period over which radiation effects may~     manifest. Current dosimetric estimations in children are based on either animal biokinetic or~     pharmacokinetic data from adults due to paucity of data that exists for children. This~     situation will be improved through the following specific aims:~        -  Collect image-based pharmacokinetic (PK) data from patient volunteers in different age~          groups scheduled for routine nuclear medicine studies for 4 radiopharmaceuticals~          commonly used in pediatric nuclear medicine~        -  Pool and analyze the data for different age groups for each radiopharmaceuticals and~        -  Generate biokinetic models to be used in subsequent dosimetric models for the~          optimization of pediatric nuclear medicine procedures.~      Since inadequate pharmacokinetic data currently exist in these patients, the investigators~     will use the data acquired in this study to establish PK models applicable to different age~     categories. Data on the pharmacokinetics of agents used in pediatric nuclear medicine are~     almost completely lacking. Internationally adopted dose coefficients (mSv/MBq) for pediatric~     nuclear medicine make age-dependent adjustments only for patient size and anatomical~     differences, while time-dependent kinetics from adult PK models are assumed due to the lack~     of kinetic data for children. The data obtained from this study will make it possible for the~     first time to determine how the PK in pediatric patients differs from adults. This will be~     done for Tc-99m dimethylsuccinic acid (DMSA), a radiopharmaceutical commonly used for~     pediatric nuclear medicine imaging. The overall hope is that results will allow the molecular~     imaging community to implement pediatric dose-reduction approaches that substantially improve~     upon current guidelines pointing to future technological advances that could yield even~     greater dose-reduction while simultaneously improving diagnostic image quality.~   "
35097|NCT03107182|"~     Carboplatin, nab-paclitaxel, and nivolumab combination will be administered for three cycles~     of three weeks duration each. TORS or RT/CRT will be performed after induction chemotherapy~     (i.e. day 64 of therapy). Patients with low risk and small volume tonsillar disease (T1-T2,~     non-bulky N2A-N2B with ≤2 non-lower neck lymph nodes measuring ≤5 cm in size) or base of~     tongue disease (T1-2 with lateralized primary ≤3 cm, non-bulky N2A-N2B with ≤2 non-lower neck~     lymph nodes measuring ≤5 cm in size) who have ≥50% reduction by RECIST following induction~     chemotherapy will undergo TORS and selective nodal dissection. De-intensified adjuvant RT~     will be given for adverse pathologic features. Patients may refuse TORS treatment.~      Patients with low risk, who do not qualify for TORS (due to volume of disease or poor~     visualization/access) or refuse TORS, who have ≥50% reduction by RECIST following induction~     chemotherapy will be given de-intensified treatment with radiation alone to 50 Gy.~      Before induction chemotherapy, patients will undergo examination under anesthesia and direct~     laryngoscopy to tattoo and photograph the primary tumor to plan the post-induction resection.~     Adjuvant nivolumab will be offered to all patients for 6-months post completion of definitive~     therapy (7 doses given as a flat dose of 480mg, every four weeks).~   "
35098|NCT03107169|"~     Investigators designed an open, two-arm study to compare oral vancomycin with a fecal~     microbiota transplant (FMT) from a fecal donor-unrelated donor mix (FURM) as treatments for~     the first Clostridium difficile infection (CDI) episode among hospitalized patients.~   "
35099|NCT03107156|"~     The overarching objective of this study is to close clinical knowledge and performance gaps~     by providing oncology clinicians with the latest advances and emerging research in the~     evidence-base and personalized treatment of advanced NSCLC patients. In addition, the~     research team seeks to meet quality measures relevant to value-based care delivery through IT~     infrastructure and clinical workflow processes. The research team also hopes to gain insights~     on clinician practice patterns related to advanced NSCLC, and the correlation between~     advanced NSCLC patients reported goals of care and advanced NSCLC patients' fit/frailty~     status and treatment decisions.~   "
35100|NCT03107143|"~     This is a non-blind randomized clinical trial to determine the efficacy of the TurnCare Q2~     System for the prevention of sacral region (sacral, coccygeal, and buttocks) pressure ulcers.~     TurnCare Q2 System has 2 main components: 1. An Inflatable Skin Perfusion Enhancement Surface~     and 2. An Adaptive Pressure Controller. The Skin Perfusion Enhancement Surface has a patented~     design that accommodate human anatomy in the sacra region. The Adaptive Pressure Controller~     is powered by APSAR technology that provides patient specific pressure relieve in the sacral~     region.~   "
35101|NCT03107130|"~     This retrospective descriptive study is to determine what proportion of Cincinnati~     Urogynecology Associates patients who underwent surgical management for stress urinary~     incontinence (SUI) would qualify for a basic office exam (BOE) alone, using the inclusion and~     exclusion criteria of the Value of Urodynamic Evaluation (VALUE) trial, and thus could have~     potentially had Urodynamic studies (UDS) omitted from their preoperative workup.~   "
35102|NCT03107117|"~     Due to the unmet needs of substance abuse treatment among court involved but~     non-incarcerated (CINI) adolescents and their parents, reaching and engaging CINI adolescents~     in intervention programs addressing marijuana use is important given the significant risk~     that continued substance use poses for re-arrest and detention. This study will examine the~     feasibility of implementing one potential model for increasing access to substance use~     interventions in a juvenile justice setting by using: 1) a computer- assisted intervention~     addressing marijuana use for adolescents, and 2) a computer program on strategies to improve~     management of teens who misuse drugs for parents.~   "
35103|NCT03107104|"~     Compare the image quality of the fundus autofluorescence and fluorescein angiography~   "
35104|NCT03107091|"~     Low-dose continuous infusion of terlipressin will be administered to six cirrhotic patients~     with refractory ascites.~   "
35105|NCT03107078|"~     For patients with active moderate-to-severe thyroid associated ophthalmopathy (TAO), the~     Intravenous Glucocorticoids (GCs) is the recommended therapy. However, the efficacy of GCs is~     not satisfied. Investigators established a novel classification of TAO for the first time to~     assess more precisely for better personal treatment.~   "
36062|NCT03094572|"~     The general objective being to determine the modifications nature induced by upper extremity~     kinematic rhythmic task realization on cervical HSCC.~      The obtained knowledge could open up new prospects for rehabilitation in cerebro-injured~     subjects in addition to existing therapeutics.~   "
35106|NCT03107065|"~     This is a pilot, open-label, and single-center, single-treatment prospective evaluation of~     the electrocoagulation of axillary sweat gland tissue using the ThermiRF device to improve~     excessive sweating of the axilla(s).~      In this study, Temporary Relief is defined as improvement on the DLQI.~      Twenty male and female subjects between 18 and 50 years old will be enrolled. A total of five~     visits are planned for this study.~      A punch biopsy will be collected (prior to and post treatment and analyzed to determine the~     degree of impact to the tissue after the electrocoagulation treatment.~      Safety assessments will be collected using the Numerical Rating Scale (NRS) a 10-point scale,~     and adverse events reports (observed or reported).~      The total length of the study is approximately 4 months.~   "
35107|NCT03107052|"~     This is a 68-week study to evaluate the long-term safety of fremanezumab in patients with CH.~     Patients who complete the pivotal studies and enroll into the current study will visit the~     investigational center for IMP administration, safety and efficacy assessments, and blood and~     urine collections for pharmacokinetics, immunogenicity (ADAs), and biomarker analyses.~     Patients will return to the investigational center for a follow-up visit to evaluate ADAs,~     fremanezumab concentrations, biomarkers, and safety (adverse events and concomitant~     medications) approximately 7.5 months after the last dose of IMP.~   "
35108|NCT03107039|"~     This study will address a gap in the literature and advance the field of minority men's~     health. Specifically, it will be the first randomized controlled trial of resistance exercise~     as a dual intervention for depression symptoms and CVD risk reduction with depressed Black~     men.~   "
35109|NCT03107026|"~     A study to evaluate a drug (dasotraline) on the safety, effectiveness and how well the body~     tolerates it, in adults with moderate to severe binge eating disorder~   "
35110|NCT03107013|"~     This is a single-centre, open-label, non-randomised, single oral dose study in healthy male~     subjects to assess the mass balance recovery of carbon-14 (14C)-BTD-001.~   "
35111|NCT03107000|"~     Corneal endothelial cells health and pumping function is crucial to permit corneal optical~     clarity by keeping cornea in relatively dehydrated state. Corneal endothelial damage has been~     associated with most types of intraocular surgery. Trabeculectomy is the standard glaucoma~     surgical intervention in management of progressive glaucoma despite of medical therapy which~     can be performed in combination with Cataract surgery (Phacoemulsification and IOL~     implantation) in patients with cataract-impaired visual acuity.~      In this study, the investigators will investigate and compare the corneal endothelial cells~     number and health status before and after trabeculectomy vs. combined surgery (at 1 month and~     3 months post-op visits) using Specular microscopy which is a non-invasive technique to~     access the structure and function of the corneal endothelium by permitting visualization of~     the corneal endothelial mosaic to assess the effect of this surgical intervention on corneal~     endothelial cells health and number.~   "
35112|NCT03106987|"~     The OReO study will be a Phase IIIb, randomised, double-blind, placebo-controlled,~     multicentre study to assess the efficacy and tolerability of Olaparib retreatment, versus~     matching placebo, in non-mucinous epithelial ovarian cancer (EOC) patients (including~     patients with primary peritoneal and/or fallopian tube cancer).~   "
35113|NCT03106974|"~     Airway management in obese patients has to consider that mask ventilation (DMV) risk is~     increased and difficult tracheal intubation (DTI) risk may be increased too.~      In obese patients, is essential to prevent early arterial oxygen desaturation related to a~     reduced functional residual capacity (FRC), atelectasis formation during anesthetic induction~     and after tracheal intubation, because oxygenation maintenance is the cornerstone of the~     airway management of the obese patient.~      Endotracheal intubation is usually required to allow unrestricted surgical approach. The~     Macintosh laryngoscope is the standard method. However, sometimes this technique is~     ineffective and poorly tolerated by the obese patient.~      The Totaltrack™ (MedComflow S.A., Barcelona, Spain) is a hybrid device, between a~     supraglottic airway and a videolaryngoscope with an anatomically shaped blade. It allows~     fibreoptic visualization of the larynx for tracheal intubation and was developed to aid both~     ventilation and tracheal intubation, at the time of anticipated and unanticipated difficult~     airway management.~      However, despite its use in clinical practice, there are no comparative studies regarding~     direct laryngoscopy in obese patients.~   "
35114|NCT03106961|"~     This study is a single-center, prospective, observational study designed to subjects~     presenting with stable angina pectoris or acute coronary syndromes requiring treatment of de~     novo lesions.~      Eligible subjects will have BVS scaffold implant using a high pressure post-scaffold~     implantation ballooning, designed to specifically address the issue of incomplete BVS~     expansion. OCT ( optical coherence tomography ) will be used to evaluate the change in the~     intraluminal scaffold volume and the prevalence of scaffold embedding from post-scaffold~     implantation to post-dilation high pressure (16-20 atm), non-compliant ballooning in relation~     to the underlying plaque.~   "
35115|NCT03106948|"~     The narrowing of Dialysis Fistulae or Grafts is a near universal problem in patients with~     end-stage renal disease (ESRD) and requires patients to undergo repeated angioplasty or~     mechanical opening of the fistula.~   "
35116|NCT03106935|"~     The present study is divided into two groups ,one is the patients with subclinical~     hypothyroidism who has TPO antibody positive women with TSH concentrations > 2.5 mU/L and~     below the upper limit of the pregnancy specific reference range ,another is TPO antibody~     negative with TSH concentrations greater than the pregnancy specific reference range and~     below 10.0 mU/L.The two groups are randomized into either the LT4 treatment group or control~     group by the use of a computer-generated list.~      The aim of our study is to determine whether the use of levothyroxine is beneficial in~     patients with subclinical hypothyroidism in two groups。~   "
35117|NCT03106922|"~     A randomised, single-blind, active controlled, multi-centre trial to evaluate the efficacy,~     safety, tolerability, acceptability and palatability of PMF104 compared to a conventional~     PEG-electrolyte solution in paediatric subjects requiring a diagnostic procedure concerning~     the colon.~   "
35138|NCT03106649|"~     The main aim of the study is to compare the proposed algorithm for preventing and treating~     spinal hypotension with normal anesthesia management of a spinal anesthesia.~      The proposed algorithm mainly will depend upon the left ventricular end diastolic area~     measurement by transthoracic echocardiography to assess the left ventricular preload status~     and its usefulness in preventing and treating spinal hypotension.~   "
35118|NCT03106909|"~     Pneumonia commonly complicates stroke and has a profound impact on clinical outcomes.~     Accurate and timely diagnosis of pneumonia complicating stroke remains a major challenge as~     several issues potentially confound diagnosis. Chest X-ray (CXR), a central component in the~     diagnostic work-up, may have limited utility in the early stages as they are often of~     suboptimal quality, and infrequently confirm typical diagnostic infiltrates. Blood biomarkers~     of the stress-immune response have received considerable attention, but interpretation has~     been limited by differing methodologies, including definition of pneumonia. Bacterial~     organisms in the oral cavity may also be of relevance as biomarkers of post-stroke pneumonia.~     Major challenges facing frontline clinicians are therefore whether to initiate antibiotics;~     if so, when and for how long. These issues have antibiotic stewardship implications for~     clinicians in terms of potential for under-treatment or over-treatment with antibiotics based~     on CXR appearances.~      Pulmonary Computed Tomography (CT) could be of value as a radiological reference standard~     when pneumonia is suspected after stroke, and enable more rigorous evaluation of the~     diagnostic performance of CXR (and other candidate biomarkers) to inform decision-making when~     pneumonia is suspected.~      The overall primary aim is therefore to investigate the feasibility and reliability of using~     pulmonary CT as a radiological reference standard for evaluating suspected pneumonia~     complicating stroke. The secondary aims are to explore the diagnostic accuracy of CXR and~     blood biomarkers (index tests) when pneumonia is suspected during hospital admission after~     stroke using pulmonary CT as a reference standard.~   "
35119|NCT03106896|"~     Postherpetic neuralgia(PHN) is a chronic neuropathic pain syndrome which persists more than 3~     months after the resolution of the acute shingles episode. PHN is a complicated neuropathic~     pain that results from the sustained peripheral injury by herpes zoster and its pathological~     mechanism in skin and spine has been reported. But the cerebral mechanism is still unclear.~     Based on the previous study that has proved the reorganization of cerebral functional~     connectivity in pain chronicity, the investigators hypothesize that the process from acute~     herpetic pain (AHP) to PHN is also accompanied with the reorganization of functional~     connectivity.In the study, the investigators intend to use 7 Tesla functional magnetic~     resonance imaging(fMRI) to observe the difference of brain activity and functional~     connectivity between acute herpetic pain and PHN. Meanwhile, the investigators examine the~     evolution of functional connectivity longitudinally in patients who is suffering from acute~     pain, so as to explore the central mechanism of transition to PHN.~   "
35120|NCT03106883|"~     Biased attention toward negatively valenced information has been considered as a mechanism~     for risk and relapse in depression. Those with depression tend to focus their visual~     attention first, more frequently, and for longer periods of time, if it connotes negative~     (particularly sad) mood. To this end, investigators have recently discovered that this bias~     might be modifiable. However, the existing literature is mixed with regard to effectiveness.~     The investigators propose in this study a novel approach to modifying attention bias in~     depression by using real time feedback with eye tracking technology. The investigators will~     examine if, compared to a sham condition, rewarding attention toward positive stimuli results~     in improved mood and reductions in attention bias. Following three sessions of either sham~     training or active attentional bias training, the investigators hypothesize that participants~     in the active training condition will experience a) reductions in negative attentional bias,~     and b) to an improved mood state and increased quality of life, compared to those in the sham~     training condition.~   "
35121|NCT03106870|"~     The purpose of the study to prove benefits of adding metformin to insulin for controlling~     presentational and gestational diabetes mellitus and improving neonatal outcome.~   "
35122|NCT03106857|"~     In total, 125 women aged between 20 and 40 years were recruited in this study. Participants~     were considered eligible when they met the inclusion criteria of being diagnosed with~     functional constipation, as defined by the Rome Foundation. The study was a randomized~     controlled trial carried out at Cairo University Hospital.Patients whose BMI exceeded 30~     kg/m2 were included. In addition, they fulfilled the ROM criteria of constipation.~   "
35123|NCT03106844|"~     In this study the investigators will evaluate patients with IBD and and at least 2 confirmed~     c.difficile infections who will be undergoing FMT. The investigators will assess patients~     before FMT and then follow patients prospectively post FMT at week 1, 8 and 12 to assess for~     recurrence of c.difficile infection and IBD outcomes.~   "
35124|NCT03106831|"~     Vasoplegic syndrome is a common complication after cardiac surgery. Low dose vasopressin can~     up-regulate blood pressure and improve clinical outcomes compared with norepinephrine (mainly~     acute kidney injury Anesthesiology 2017; 126:85-93). Pituitrin is used as a substitute for~     vasopressin in our center, which contains both vasopressin and oxytocin. Oxytocin may~     alleviate inflammatory process-associated kidney injury (Peptides 2006;27:2249-57).~     Therefore, the investigators hypothesize Pituitrin may be preferable to norepinephrine in the~     renal protection of patients with vasoplegic syndrome after cardiac surgery. Moreover, the~     serum levels of vasopressin, catecholamine, corticosteroid and corticotropin-releasing~     hormone will be measured.~   "
35125|NCT03106818|"~     Effective pain relief after cardiac surgery has assumed importance with the introduction of~     fast track discharge protocols that requires early weaning from mechanical ventilation.~     Inadequate pain control reduces the capacity to cough, mobility, increases the frequency of~     atelectasis, and prolongs recovery. Infiltration of local anesthetics near the surgical wound~     has shown to improve early postoperative pain in various surgical procedures.~      Magnesium is the fourth most plentiful cation in our body. It has antinociceptive effects in~     animal and human models of pain.~   "
35126|NCT03106805|"~     The optimal interval between pregnancies is debated, but a duration greater than 11-18 months~     has been suggested as reducing complications in the subsequent pregnancy. Improved birth~     spacing can be a key benefit use of long-acting reversible contraception, but delay to~     initiation can still be problematic.So women who have recently given birth can be~     cost-effectively targeted for family planning education and engagement because often they are~     already connected with health professionals~   "
35127|NCT03106792|"~     The primary outcome of the study is the effect of Hairfinity vs. Placebo on the rate of~     distal hair growth, assessed using Trichoscan HD, in healthy female adults from baseline to~     day 90 (end of study).~   "
35130|NCT03106753|"~     The purpose of this study is to determine the best way to optimize the success of external~     cephalic version (turning the baby from the outside). Attempting to turn babies in-utero is~     recommended because it may decrease the risk of needing a cesarean section for abnormal~     presentation. While the study team knows that this procedure can be effective, the study team~     still has some un-answered questions as to the best way to perform this procedure to increase~     the chance of success. Many prior studies have shown that using spinal anesthesia (a shot of~     medication placed in your back to numb and relax the abdomen) can increase the success rate~     of a version. This ultimately has led to the finding that using this anesthesia can decrease~     the rate of cesarean section. However, there have been only a small number of studies~     assessing the success rate if spinal anesthesia is used only in the event that without it~     fails. Therefore the study team is going to compare patients who receive spinal anesthesia~     with those who only receive spinal anesthesia if the procedure to turn the baby (ECV) fails~     without it.~   "
35131|NCT03106740|"~     In this research, the study team will use brain imaging to evaluate the presence of~     neuroinflammation in the brains and spinal cords of patients with low back pain. The efficacy~     of minocycline use for low back pain treatment will also be evaluated by observing whether~     short-term minocycline administration will reduce neuroinflammation and low back pain~     symptoms.~   "
35132|NCT03106727|"~     This protocol concerns the implementation and evaluation of an intervention designed to~     realign the existing cadre of Community Health Workers (CHW) in Neno District, Malawi to~     better support the care needs of the clients they serve. The proposed intervention is a~     'Household Model' where CHWs will be assigned to households, rather than HIV or TB specific~     patients, and will be trained to provide support for a wider range of conditions including~     HIV, hypertension, diabetes, and pediatric malnutrition. The new model is designed to improve~     retention in care for clients with chronic, non-communicable diseases, along with increased~     uptake of women's health services and treatment for pediatric malnutrition, while sustaining~     the high retention rates for clients in the HIV program. Eleven sites (health centres and~     hospitals) were arranged into six clusters by estimated size of the catchment area~     populations, with a population range of 11,680 to 26,260 and an average population of 20,400.~     The order in which the intervention will be rolled out across the sites will be randomized so~     that the intervention can be evaluated in a stepped-wedge cluster randomized controlled~     trial. These clusters were grouped based mostly on geographic location but also on catchment~     area sizes, in order to maximize feasibility of training for the CHW team and not overload~     CHW training sessions with too many trainees.~   "
35133|NCT03106714|"~     The Zika infection is a viral disease that is transmitted to humans by the same mosquito that~     transmits Dengue and Chikungunya fever. The Zika virus has been found in various body fluids~     such as urine, blood and semen, but we do not know how long it persists in these fluids. For~     example, parts of the virus were reported to persist in semen after six months of the onset~     of symptoms, but we do not know if the virus can stay longer. In this way, we want to~     investigate how long the Zika virus can be found in other secretions besides blood and urine.~      Study Hypothesis: ZIKV can be shed in human body fluids long after the time of the acute~     infection. Persistence of ZIKV in different body fluids may vary due to the influence of~     circulating specific ZIKV IgM and IgG, as well as host and environmental factors.~   "
35134|NCT03106701|"~     This study represents an extension of a previous study (NCT02641431) on the acute and~     long-term benefit of epicardial ablation on elimination of both BrS-ECG pattern and VT/VF~     inducibility in 500 consecutive BrS patients.~   "
35135|NCT03106688|"~     The goal of this project is to characterize the neural and psychological mechanisms that~     contribute to development of obesity in the early adulthood. We address the neuromolecular~     risk factors for obesity using multi-modal molecular (positron emission tomography with) and~     functional (functional magnetic resonance imaging) neuroimaging in a prospective design.~     Normal weight adolescents with high versus low familial, genetic and psychological risk~     factors for obesity will be studied and followed for five years.~   "
35136|NCT03106675|"~     Bone metastasis give rise to major complications that lead to significant morbidity and~     impairment of life quality. The most common primary for bone metastasis is prostate, lung and~     breast carcinoma. These three have the highest cancer incidence in the USA with up to 85%~     prevalence of bone metastases at the time of death. Pain from these osseous lesions can be~     related to mechanical or chemical factors. Pressure effects on the periosteum or adjacent~     neural structures can cause local or radiating pain. Hemorrhage from local bone osteolysis by~     osteoclastic activity causes a local release of bradykinin, prostaglandins, histamine and~     substance P that can irritate the endosteal nerves as well as local nerves.~      The life expectancy of patients with osseous metastatic disease is variable but can be~     substantially longer for patients with multiple myeloma, breast or prostate cancer.~     Therefore, finding an effective local therapy that can improve patient quality of life and~     can be done at a single outpatient sitting would be beneficial.~      The current and emerging treatments for osseous metastases may be considered in several~     categories: radiotherapy, systemic chemotherapy (cytotoxic, hormonal and radionuclides),~     surgical stabilization and percutaneous tumor ablation. These treatments may be applied in~     isolation but also frequently in combination.~      MRI Guided High Intensity Focused Ultrasound (HIFU) is a completely non-invasive technology~     for thermal ablation. HIFU is capable of concentrating ultrasonic pressure waves to a~     specified region without any physical penetration of the body. The converging ultrasonic~     pressure wave is converted to thermal energy at the specific depth, resulting in local~     heating at the focus. Temperature elevation is proportional to the proton resonance frequency~     shift, therefore MR imaging provides accurate technique for target definition and energy~     deposition control. MRI guided Focused Ultrasound therapy is being performed in treatment of~     uterine leiomyomas (fibroids). Recently the method has gained both AMAR authorization and FDA~     approval, and CE approval for that indication.~      Clinical trials of HIFU in bone metastases have indicated that the method is safe and gives~     an effective reduction of patient pain. The short- and long-term effects on tumor volume and~     morphology do not seem to have been evaluated thus far.~      The primary objective of this trial is to evaluate effectiveness of MRI guided HIFU in the~     treatment of metastatic bone tumors~   "
35137|NCT03106662|"~     Mesenchymal stem cells (MSCs) have been used in the treatment and prevention of graft-versus~     host disease (GVHD). In this study the investigators aim to present the efficacy of~     mesenchymal stem cells in graft versus host disease prophylaxis and effect of engraftment in~     haploidentical recipients. Forty patients aged older than 18 who have indications for~     haploidentical hematopoietic stem cell transplantation will be included to the study. MSCs~     will be isolated from donor bone marrows and infused to the patient after conditioning~     regimen on day +6. If the haploidentical transplantation results improve with MSCs treatment~     it would be possible to ameliorate the problem of HLA-matched donor paucity in Turkey and~     prefer haploidentical donors.~   "
36296|NCT03091517|"~     This single arm pilot study will explore the feasibility of GlycoLeap, a proprietary online~     lifestyle modification and self-management education program developed in Singapore for~     people with type 2 diabetes, as an add-on to primary care delivered through one of the~     SingHealth Polyclinics.~   "
35141|NCT03106610|"~     The goal of this clinical research study is to learn about the tolerability of nivolumab in~     patients who have bladder cancer, were previously treated with BCG immunotherapy, and who~     have a cystectomy (removal of all or part of the bladder) scheduled as part of their standard~     care.~      This is an investigational study. Nivolumab is FDA approved and commercially available to~     treat metastatic (has spread) melanoma or non-small cell lung cancer (NSCLC) after the~     disease has gotten worse while receiving platinum-based chemotherapy. The use of nivolumab in~     this study is considered investigational.~      Up to 10 participants will take part in this study. All will be enrolled at MD Anderson.~   "
35142|NCT03106597|"~     The purpose of this study is to evaluate the effect of a third-generation Calcium Channel~     Blocker (CCB), manidipine, compared with second-generation Calcium Channel Blocker (CCB),~     amlodipine, on the development of peripheral edema using Direct Segmental Multi-Frequency~     Bioelectrical Impedance Analysis (DSM-BIA) method in patients with mild to moderate essential~     hypertension. Investigator expects this study could show more objective evidence of better~     safety of manidipine compared with amlodipine for peripheral edema.~   "
35143|NCT03106584|"~     The purpose of the study is to test 30 individuals with mild-moderate knee joint~     osteoarthritis to investigate whether the combination of Aquamin (a calcium-rich marine~     multi-mineral) and a polyphenol-rich pine bark extract (Enzogenol), when taken as a food~     supplement for 3 months has comparable or superior benefits to glucosamine sulphate in~     patients with painful knee osteoarthritis (KOA). From here on in we refer to Aquamin's~     combination product as Aquamin-plus. The main outcome measure is a reduction in pain.~      Provision of data that demonstrate preliminary equivalency or superiority to current,~     non-pharmaceutical options such as glucosamine will broaden consumer choice, and provide them~     with an option that is supported by science, rather than marketing alone.~      The hypothesis of the study is that the consumption of Aquamin-plus will have comparable~     effects on reducing pain in individuals with Knee Joint OA to glucosamine.~   "
35144|NCT03106571|"~     This is the first study of pomaglumetad in humans using methamphetamine. The goal of the~     study is to determine if pomaglumetad is safe when administered with methamphetamine. If~     shown to be safe with methamphetamine in the current study, a phase 2 clinical trial of~     pomaglumetad would be done to begin to find out if pomaglumetad is effective in treating~     methamphetamine use disorder.~   "
35145|NCT03106558|"~     This is an early user evaluation of the robotic-assisted total knee arthroplasty platform.~     The objective of this surgeon group is to capture data on the defined objectives and provide~     Stryker with feedback.~   "
35146|NCT03106545|"~     Postoperative analgesia for hallux valgus surgery (bunionectomy) is inconsistent and may even~     result in rebound pain when the (ankle) blocks wear off. It is hypothesized that the mixture~     of bupivacaine and liposome bupivacaine increases the extent and duration of postoperative~     analgesia and decreases opioid consumption as compared to bupivacaine alone or to general~     anesthesia.~   "
35147|NCT03106532|"~     Evaluation of the optimal dose for the efficacy in reduction of intraocular pressure and~     safety of PHP-201 ophthalmic solution in patients with normal tension glaucoma~   "
35148|NCT03106519|"~     Treatment of Dupuytren's contracture requires multiple injections into the palm of the hand~     to weaken the cords, followed by rupture of the strands 2 days later. Anesthesia is required~     for both phases of treatment. It is hypothesized that extended-release liposome bupivacaine~     prolongs nerve blockade of the wrist allowing patients to undergo this 2-part regimen with~     less pain.~   "
35149|NCT03106506|"~     The objective of this randomized controlled clinical study was to evaluate the increase in~     the volume of peri-implant gingival tissue in implants installed in the aesthetic areas with~     the use of subepithelial-conjunctive tissue graft, and a sample of 40 individuals with~     implants Aesthetics where the test group (n = 20) will receive tec graft. (N = 20) will~     receive only the dental implant without the placement of a tec graft.~     Epithelial-conjunctival.~   "
35150|NCT03106493|"~     The goal of the Upstate KIDS Study is to track the growth, development and long-term health~     of children given the increasing use of infertility treatment, occurrence of maternal obesity~     and pregnancy complications, and rising maternal age at birth.~   "
35151|NCT03106480|"~     Emerging evidence from high-income countries suggests that diabetes mellitus is become a~     major health problem among HIV-infected patients. However, due to differences in social,~     environmental, and genetic factors data from high-income countries can not be extrapolated~     directly to low-income countries. This study investigates HIV, ART, inflammation, and body~     composition changes as risk factors for diabetes mellitus among HIV-infected patients in~     Tanzania.~   "
35152|NCT03106467|"~     Despite growing popularity, practical advantages of single-port laparoscopic appendectomy~     (SLA) over conventional three-port laparoscopic appendectomy (CLA) have yet to be established~     well in pediatric population.~      The investigators designed the randomized controlled trial to clarify practical advantages of~     SLA over CLA in pediatric population. The investigators compared conversion rate,~     intra-operative adverse events, operating time, wound complications, intra-abdominal~     complications, and postoperative hospital stay, changes in postoperative pain severity, and~     cosmetic outcomes during follow up period between SLA and CLA groups.~   "
35153|NCT03106454|"~     Since the introduction of the combined hormonal contraceptive pill, dosages of ethinyl~     estradiol (EE) have steadily decreased from more than 150mcg to 20mcg in an attempt to~     improve the risk profile associated with the COC. In 2010, the Food and Drug Administration~     approved a oral contraceptive pill containing EE 10mcg/NET acetate 1mg (Tradename Lo~     loestrin). However, no studies have compared this formulation to pills containing either~     higher doses of estrogen or progestin alone. It is not known whether EE 10mcg is sufficient~     to prevent follicular development or to support the endometrium as well as higher doses of~     EE. This trial addresses the question of whether an oral contraceptive pill with EE~     10mcg/Norethindrone acetate 1mg will better suppress ovulation or have a better side effect~     profile than a progestin only pill with a nearly equal dose of norethindrone.~   "
35154|NCT03106441|"~     Oro-tracheal intubation in operating room in obese patients with BMI > 35kg/m2 remains a~     critical event. The aim of this study is to determine whether Nasal High Flow Therapy by~     nasal cannula Optiflow® is more efficient than the BIPAP preoxygenation before orotracheal~     intubation after crash induction in obese patients~   "
35156|NCT03106415|"~     This phase I/II trial studies the best dose of pembrolizumab and binimetinib and how well it~     works when giving together with pembrolizumab in treating patients with triple negative~     breast cancer that has spread to other parts of the body. Monoclonal antibodies, such as~     pembrolizumab, may block tumor growth in different ways by targeting certain cells.~     Binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth. Giving pembrolizumab and binimetinib may work better in treating patients with~     triple negative breast cancer.~   "
35157|NCT03106402|"~     To assess the incidence, risk factors and clinical courses of cystic macular lesions (CMLs)~     after uncomplicated phacoemulsification and evaluate the efficacy of topical NSAIDs on the~     prevention of pseudophakic cystic macular lesions~   "
35158|NCT03106389|"~     This randomized controlled study will be performed to compare the benefits and risks~     associated with the administration of misoprostol with or without the use of a transcervical~     balloon catheter to terminate pregnancy in the second trimester (defined as gestational age~     between 14 and 28 weeks of gestation).~   "
35159|NCT03106376|"~     This study evaluates the impact of hypoxic and hyperoxic breathing on measures of brain redox~     balance and metabolism in healthy individuals. All participants will undergo an MRI scan~     during administration of air mixtures with different oxygen concentrations to collect the~     brain measures.~   "
35160|NCT03106363|"~     Alcohol and cannabis are the two most widely used substances of abuse in the world and are~     the psychoactive substances most often found in seriously and fatally injured drivers. In a~     recent study, it was observed that individuals who reported both driving under the influence~     of alcohol (DUIA) and the influence of cannabis (DUIC) experienced collision risk that was~     nearly 4 times that of individuals who reported driving after using only one of these drugs.~     Recent research in the United States and Canada indicates that the prevalence of DUIC among~     young drivers of high school and university age, and young adults is similar to, or higher~     than, the prevalence of DUIA. This is a serious public health issue, since motor vehicle~     collisions are the leading cause of death in this age group. Given the frequency with which~     alcohol and cannabis are consumed together, it is important to understand their combined~     effects on driver behaviour. The residual or 'hangover' effects of these substances on road~     safety are also not well understood, but may be substantial. To date, the residual effects of~     combined use have not been examined. The current study will examine the acute and residual~     effects of a moderate dose of cannabis (12.5% THC) combined with an intoxicating amount of~     alcohol (BAC=0.08) on driving simulator performance of young drivers. Following an~     eligibility screening and practice session, a total of 70 participants aged 19 to 25 years~     will each complete 8 experimental sessions (2 sessions/week). During the first session of~     each week, subjects will drink alcohol or placebo alcohol and smoke an active or placebo~     cannabis cigarette. The effects of alcohol and cannabis on the performance of driving-related~     skills will be assessed using a high-fidelity driving simulator. Cognitive, psychomotor, and~     mood effects will also be assessed. Twenty-four hours after alcohol/drug exposure, subjects~     will attend the second session of the week where driving-related, cognitive, psychomotor, and~     mood effects will be assessed again.~   "
35161|NCT03106350|"~     EORTC-QLQ-30 questionnaire filled in by participants 6 times~   "
35162|NCT03106337|"~     As many as 70-85% subjects diagnosed with a follicular lesion on biopsy and undergoing~     surgery will have benign lesions verified by histopathology after surgery.~      Currently there is no method of pre-operatively diagnosing benign follicular lesions, as a~     result these subjects will have had surgery for diagnosis of a benign lesion.~      The aim of this study is to see whether shear-wave elastography, a new ultrasound technology~     can help pre-operatively diagnose benign follicular lesions. If successful, a lot of patients~     will not need surgery for the diagnosis of a benign lesion.~      The main goal of this study will be to evaluate the diagnostic accuracy of a new ultrasound~     technology, shear-wave elastography (SWE), for the diagnosis of malignancy in follicular~     lesions. Participants who have been diagnosed with a follicular lesion on thyroid biopsy and~     are scheduled for thyroid surgery will be eligible to participate. All participants will~     undergo a detailed ultrasound examination prior to their surgery. The results of the~     ultrasound will be compared with histopathology after surgery to test the diagnostic accuracy~     of SWE.~   "
35163|NCT03106324|"~     This post authorization safety study is designed as prospective non interventional study for~     patients with newly diagnosed multiple myeloma who are not eligible for transplant. The~     objective is to compare the incidence of cardiovascular events between patients treated with~     a first-line lenalidomide containing regimen and those treated with a first-line~     non-lenalidomide containing regimen. Treatment in both cohorts will be done according to~     standard care. The study will gather risk factor information at baseline and throughout~     follow-up. Any cardiovascular event occurring will be assessed by an independent committee.~     Other safety endpoints will be collected through standard procedures. Observation period will~     be 3 years on treatment, with an additional evaluation of cardiovascular events 6 months'~     post treatment and a follow up period until 5 years after inclusion. During follow up the~     incidence of second primary malignancies (SPM) and overall survival will be assessed.~   "
35164|NCT03106311|"~     Two groups will be recruited. The first group are pregnant ladies that have unequivocal~     rupture of fetal membranes that is diagnosed by seeing the amniotic fluid leakage in the~     vagina. The second group are normal pregnant ladies without rupture of membranes. both groups~     will be tested by taking vaginal washing fluid. Quantitative and qualitative pregnancy tests~     will be measured in this fluid.~   "
35165|NCT03106298|"~     This study investigates the effects of intravenous (IV) iron sucrose therapy on blood levels~     of Fibroblast Growth Factor 23 (FGF23, a protein that regulates the amount of phosphate in~     the body) in iron deficiency anemia in healthy participants, participants with Congestive~     Heart Failure (CHF, where the heart does not pump adequate blood supply to the body),~     participants with Chronic Kidney Disease (CKD, where the kidney function is reduced), and~     participants with CKD and CHF.~   "
35166|NCT03106285|"~     This study aims to investigate the effectiveness of Lactobacillus reuteri DSM17938~     supplementation on infantile colic in Indonesian infants.~   "
35167|NCT03106272|"~     To describe AMH serum levels dynamics during natural cycle using an automated assay.~   "
35168|NCT03106259|"~     Observational Study to evaluate the safety of FURESTEM-RA lnj. in moderate to severe~     rheumatoid arthritis patients who participated in phase 1 clinical trial of FURESTEM-RA lnj.~   "
35169|NCT03106246|"~     Beta-cells release extracellular vesicles (EV) and exosomes under normal and pathophysiologic~     conditions. These EV contain beta-cell specific autoantigens which may trigger the immune~     response at the initiation of type 1 diabetes. In this study, beta-cell derived EV will be~     detected and characterized in human blood samples.~   "
37214|NCT03079518|"~     Effects of ferric carboxymaltose single HD (1000 mg) infusion upon FGF23 in patients with~     isolated HFREF compared to patients with HFREF+CKD (all pts with iron deficiency). This study~     aims at identification of the optimal target population for a follow-up (main) study.~   "
35171|NCT03106220|"~     Skeletal muscle abnormalities (sarcopenia) and frailty are common complications seen in~     patients with end-stage liver disease. The presence of these complications portends poor~     prognosis. The purpose of this study is to assess the impact of a formal home based video~     strengthening program (REST) on sarcopenia and frailty. We also want to assess the impact of~     this exercise program on complication rates, hospitalization, on quality of life (QOL) and on~     survival.~   "
35172|NCT03106207|"~     Despite the high success rates of gastric bypass in the short and long terms, little is known~     about possible anatomopathological changes that can occur in these patients. The objective is~     to investigate preoperative and postoperative endoscopic changes in patients undergoing~     gastric bypass without a ring. Thirty obese patients from different regions of the country~     with the surgical indication for the Roux-en-Y gastric bypass will be studied prospectively.~     All patients will be submitted to upper gastric endoscopy (UGE) two, six and 12 months after~     the surgical procedure at the Kaiser Clinic. This study will identify whether there are~     endoscopic changes within one year after the surgery and what they are. Changes, if they~     exist, will be correlated with clinical data, in order to make an accurate prognosis of the~     patient, thereby contributing to the outcomes of future patients submitted to this type of~     procedure.~   "
35173|NCT03106194|"~     To study the impact of case management on the outcome of the care of chronic hepatitis C in~     people who inject drugs (PWID). By creating the function of case manager, the investigators~     will target all the barriers to care of the HCV care continuum. Partial objectives are to~     measure the impact of case management on the uptake for screening, the uptake and outcome of~     treatment, and the rate of reinfection.~   "
35174|NCT03106181|"~     Glaucoma is the commonest cause of irreversible blindness in the world. Treatment centres~     around lowering intraocular pressure (IOP) and typically includes medication (least~     invasive), laser, to surgery (most invasive). The gold-standard glaucoma operation is the~     trabeculectomy. Whilst it is effective at lowering IOP, it is associated with potentially~     devastating complications including bleb leak, hypotonous maculopathy, blebitis and~     endophthalmitis. In recent years, minimally- invasive glaucoma surgery (MIGS) has become an~     increasingly popular option of treating mild to moderate glaucoma. It is usually performed in~     conjunction with cataract surgery. The iStent (Glaukos Corporation, California, USA) is one~     of the most commonly utilised MIGS devices in the world and one of two Therapeutic Goods~     Administration (TGA)- approved MIGS devices in Australia. The iStent Inject® is the second~     generation iStent device and Australia is one of the first countries in the world to have~     access to this. So far there are no published randomised controlled trials comparing the~     effect of cataract surgery alone to combined cataract surgery with insertion of iStent~     Inject®.~      This study aims to recruit patients of the Glaucoma Investigative and Research Unit (GIRU) of~     Royal Victorian Eye and Ear Hospital (RVEEH) with mild to moderate glaucoma who are due to~     undergo cataract surgery and randomise each to either cataract surgery or combined cataract~     surgery with iStent Inject® insertion. Only patients who meet the inclusion criteria and none~     of the exclusion criteria will be recruited. The outcomes measures of the study will be a~     comparison of: 1) extent of IOP reduction; 2) reduction in number of topical glaucoma~     medications; 3) patient treatment satisfaction - between the two treatment groups.~   "
35175|NCT03106168|"~     To evaluate subjectively and objectively the quality and efficacy of local anesthetic block~     with mepivacaine in simple extraction of mandibular molar. Provide and collect information~     such as: signs and symptoms, quality of anesthetic block, quantify pain and / or discomfort,~     as well as medication used, both preoperatively and postoperatively.~   "
35176|NCT03106155|"~     [Study Design] This study is a single arm, multi-center phase II study of vistusertib~     monotherapy in patients with relapsed small cell lung cancer (SCLC) harboring RICTOR~     amplification. Patients will receive vistusertib monotherapy (50 mg BID per os every 12~     hours) until they demonstrate objective disease progression or they meet any other~     discontinuation criteria.~      [Primary Objective] To investigate the efficacy of vistusertib monotherapy in patients with~     relapsed SCLC patients harboring RICTOR amplification as 2nd or 3rd line therapy~   "
35177|NCT03106142|"~     The aim of this study is to improve the referral rates to physiotherapy of patients with knee~     osteoarthritis. The intervention consists of one academic detailing visit directed to general~     practitioners (GPs)~   "
35178|NCT03106129|"~     Total knee arthroplasty (TKA) may result in significant postoperative pain. The majority of~     these patients are prescribed opioids for the management of postoperative pain. Recent~     evidence has highlighted that postoperative opioids are being over-prescribed resulting in~     opioid misuse and abuse. Over-prescribing also results in a significant financial cost. This~     prospective observational study was designed to determine the mean amount of opioid required~     after TKA. This data can be used in the future as a guide to change our current practice of~     prescribing with the aim to reduce over-prescription.~   "
35179|NCT03106116|"~     The purpose of this study is to investigate the efficacy of Enhanced External~     Counterpulsation (EECP) therapy on ventricular function in patients with coronary heart~     disease~   "
35180|NCT03106103|"~     Urodynamic Study (UDS) represents a series of agreed-upon clinical tests and is used to~     evaluate the functional status of the lower urinary tract, providing a pathophysiological~     basis for urinary symptoms. Urodynamic Study involves catheterization of the lower urinary~     tract. The prevalence of urinary tract infection after UDS ranges from 1,5% to 30 %.~      Studies of prophylactic antibiotics for UDSs have offered data of contradictory and limited~     predictive values. Some investigators concluded that prophylactic antibiotics were valuable~     and others have not.~      The objective of this study is to evaluate the efficacy of antibiotic prophylaxis before UDS~     in women, using different antibiotic regimens.~   "
35192|NCT03105947|"~     This is a randomised trial in which healthy volunteers, men and women aged 50-75 years from~     the general community are randomized into one of three arms: participants will be provided~     with 50 gm extra virgin coconut oil,or 50 grams butter or 50 extra virgin olive oil to be~     eaten daily for a month. The key outcome is blood low density lipoprotein cholesterol~     concentrations and secondary outcomes blood lipid profile (total cholesterol, high density~     lipoprotein cholesterol, triglycerides) and anthropometric measures: weight and waist~     circumference. This trial is powered to detect a difference of 0.5 mmol/L LDL-cholesterol~     difference between the trial arms.~   "
35181|NCT03106090|"~     The study will focus on survivorship care for head and neck cancer patients cared for within~     Duke Cancer Center clinics. Standardized survivorship care plans (sSCP) are being implemented~     based on the American Society for Clinical Oncology's criteria. These documents provide a~     summary of treatment received, and list side effects and follow-up information after cancer~     treatment. Taking advantage of this transition, the investigator will study three groups of~     patients: (a) early survivors treated before the sSCP was implemented, (b) early survivors~     treated after the sSCP was implemented, and (c) current patients who will receive an~     individualized enhanced SCP (eSCP), which will include additional information tailored to~     patient preferences. The investigators hypothesize that patients receiving enhanced~     survivorship care plans will increase their knowledge regarding their health care plan and~     wellness trajectory; increase their ability to identify the symptoms they most likely can~     expect as a result of their cancer treatment; and be more likely to engage in conversations~     with their PCP about healthy behaviors and screening guidelines.~   "
35182|NCT03106077|"~     The goal of this clinical research study is to learn if mirvetuximab soravtansine can help to~     control either newly diagnosed or metastatic (has spread) triple-negative breast cancer~     (TNBC).~      Mirvetuximab soravtansine is designed to stop cell growth by blocking certain proteins in the~     cancer cells related to the mineral folate. This is believed to cause the cancer cells to~     die.~   "
35183|NCT03106064|"~     This study is a randomized clinical trial conducted in a medical ward of an acute 580-bedded~     teaching hospital. One hundred fifty-eight older acute medical patients will be blindly~     randomly allocated to the control group or intervention group. The intervention will consist~     of a twice daily walking training, plus privileging trips to the toilet by walking and all~     daytime meals seated. Differences between groups will be measured at baseline (admission) and~     discharge. As primary outcomes, we defined the length of stay and the independence level. The~     independence level will be assessed at baseline (admission) and discharge by two distinct~     methods: through the Barthel Index and the Patient Classification Systems(PCS).~   "
35184|NCT03106051|"~     A total of approximately 500 patients with active psoriatic arthritis in an estimated 80 to~     100 trial centers are to be enrolled. Selection of centers will be made by the sponsor's~     medical section. To increase the quality of the data and to reduce distribution of the data~     collected, centers to be included will be those which can enroll at least 5 patients. Care~     will be taken to ensure a balanced regional distribution. The proposed observation period for~     the trial is approx. 52 weeks per patient. Estimated patient enrolment is also 52 weeks.~     Proposed duration from first patient in (FPI) to last patient out (LPO) is thus 24 months.~   "
35185|NCT03106038|"~     The purpose of this clinical trial is to study the safety and efficacy of an investigational~     imaging agent for delineation/visualization of urologic anatomy in the setting of minimally~     invasive surgery.~   "
35186|NCT03106025|"~     The study is collecting data along with other academic institutions regarding the accuracy of~     ocular ultrasound in diagnosing retinal detachment.~   "
35187|NCT03106012|"~     The hysteroscopy used was rigid continuous flow diagnostic hysteroscopy (Tuttligen, Karl~     Storz, Germany). It has a 30o panoramic optic which is 4mm in diameter and the diagnostic~     continuous flow outer sheath is 6.5 mm in diameter.~      The patient was placed in lithotomy position with the buttocks projecting slightly beyond the~     table edge. A reflex camera (Olympus) with an objective that has a focal length varies from~     f70 to f140 together with (Karl Storz) special zoom length, adapter to Hopkins telescope and~     a suitable cableware used with computer flash unit. The hysteroscopic picture which appeared~     through the optic, transmitted on the monitor by the camera which is fitted on the eyepiece~     of the optic where the panoramic diagnostic hysteroscopy could be informed with better~     visualization and accuracy. The light generator which is a metal halide automatic light~     source with a 150 watt lamp (model G71A,Circon ACMI, Germany) was switched on and the high~     cable was attached to the hysteroscope. Dilatation of the cervix was avoided whenever~     possible to avoid leakage of the medium into the vagina. The hysteroscope was then introduced~     into the external os and advanced under vision along the axis of cervical canal.~      Once the cavity was entered, an overview of the uterine cavity was performed. This was~     followed by systematic examination for fundus then tubal ostia on both sides then the uterine~     wall through slow rotatory movements of the telescope.~      Diagnostic laparoscopy was done in the proliferative phase of the menstrual cycle .The~     patients were placed in the dorsal lithotomy position to allow vaginal access for uterine~     manipulation; the legs positioned so that the thighs are slightly flexed no more than 90o~     from the plane of the abdomen.~      The patient was placed in the complete horizontal position, Veress needle was placed through~     the umbilicus and into the peritoneal cavity, the primary trocar with sleeve (5mm in~     diameter) was placed at a similar angle in to the Veress needle.~      Secondary trocars were used, 2 secondary trocars were placed. The trocars were placed~     laterally, approximately 8 cm from the midline and 8 cm above the pubic symphysis to avoid~     the epigastric, vessels which are 5.5 cm from the midline at this level.~      Then laparoscopic dye chromotubation was performed~   "
35188|NCT03105999|"~     In COPD patients, a distinctive clustering of symptoms in the 3 parts of the day, early~     morning, day-time and night-time has been observed. These clusters are relevant to shape the~     health status and to explain the need of care. The objective of the STORICO study is to~     quantify the intra-day fluctuation of symptoms and to verify whether it: marks selected COPD~     phenotypes and is stable over time. STORICO is an observational prospective cohort~     multicenter study. 600 COPD patients >50 years will be enrolled. The multidimensional~     assessment will cover pattern of symptoms, complete spirometry and DLCO (Diffusing capacity~     of Lung for Carbon Monoxide ), comorbidity and health status. Based on clinical data,~     patients will be grouped in clinical phenotypes. Intra-day symptoms fluctuation will by rated~     by standardized questionnaires and the relationship between clinical/statistical clusters and~     symptoms fluctuations assessed. Finally, patients will be reassessed at 6 and 12 months, and~     the 12 month incidence of selected outcomes (frequency of exacerbations, use of health care~     resources) will be computed. Results are expected to clarify the classificatory and~     prognostic role of symptoms fluctuations in addition to classical measures of disease status~     and to compare health status and prognosis of clusters. Intra-day variations and stability of~     symptoms over time will likely improve our understanding of phenotypic variability of COPD.~   "
35189|NCT03105986|"~     The purpose of this study is to evaluate the effect of multiple-dose administration of~     probenecid on the pharmacokinetics of JNJ-63549109 and JNJ-64167896 after a single dose of~     JNJ-64041575 in healthy adult participants.~   "
35190|NCT03105973|"~     In the United States, over 60% of the 2.2 million people who are incarcerated struggle with~     mental health problems. Currently, correctional facilities are limited in their ability to~     provide care. As technology-enabled interventions for mood disorders have demonstrated~     efficacy outside of correctional facilities, the investigators propose to build and test a~     technology-enabled mood disorder treatment intervention for individuals who are incarcerated.~   "
37233|NCT03079271|"~     To evaluate the short term effects of LACRISERT®. upon fluorescein corneal staining, tear~     osmolarity and surface topography in human subjects with dry eye disease.~   "
35195|NCT03105908|"~     The overall aim of the present study is to evaluate an internet-delivered Acceptance and~     Commitment therapy treatment (iACT) for patients with chronic pain. More specifically, the~     study will evaluate if 1) iACT is effective in improving functioning and quality of life in~     comparison to a waitlist condition, 2) if iACT is cost-effective, 3) factors that influence~     treatment outcome (i.e. predictors, moderators or characteristics of treatment responders),~     4) if psychological variables mediates the effects of treatment on outcome, and 5) if~     subgroups of patients varies in change processes (i.e. moderated mediation).~      The main hypothesis is that iACT will improve functioning and quality of life.~   "
35196|NCT03105895|"~     It has been demonstrated that incisional hernia incidence after laparotomy can be safely~     reduced with the addition of a mesh to the conventional closure of the abdominal wall. There~     still some debate about which is the best position to place this mesh: onlay or sublay. In~     Europe we have now meshes with CEE approval to be used as reinforcement of abdominal wall~     closure. The investigators have planned to include 200 patients in a multi center study using~     an onlay PDVF mesh that can be tracked by magnetic resonance. The patients included will be~     patients with risk factors for the development of an incisional hernia. The incidence of~     incisional hernia will be assessed clinically and radiologically after 1 and 2 years~     follow-up. The incidence of surgical sites occurrences and pain will be also assessed.~   "
35197|NCT03105882|"~     Pilot Study of Clinical Safety and Feasibility of the Neuro-Spinal ScaffoldTM for the~     Treatment of Complete (AIS A) Traumatic Acute Spinal Cord Injury at the C5-T1 Neurological~     Levels The purpose of this study is to support an expansion to support marketing applications~     as well as future studies.~   "
35198|NCT03105869|"~     Monocentric study. Objective : Determination of the repeatability of fluorocholine PET/CT in~     prostate cancer~   "
35199|NCT03105856|"~     Objective. To evaluate the impact of HPV vaccination as part of a hrHPV-based primary~     screening program to extend screening intervals.~      Materials and methods. A total of 18,000 women aged 25-45 years, attending the regular~     cervical cancer-screening program in primary health care services in Tlalpan, Mexico City,~     will be invited to the study. Eligible participants will be assigned to one of three~     comparison groups: 1) HPV16/18 vaccine and hrHPV-based screening; 2) HPV6/11/16/18 vaccine~     and hrHPV-based screening; 3) Control group who will receive only hrHPV-based screening.~     Strict surveillance of hrHPV persistent infection and occurrence of precancerous lesions will~     be conducted to estimate safety profiles at different screening intervals; participants will~     undergo diagnosis confirmation and treatment as necessary.~      Discussion: The FASTER-Tlalpan Study will provide insights into new approaches of cervical~     cancer prevention programs. It will offer valuable information on potential benefits of~     combining HPV vaccination and hrHPV-based screening to safety extend screening intervals.~   "
35200|NCT03105843|"~     The objectives of this study are to determine the sensory-mechanical responses to Eucapneic~     Voluntary Hyperventilation (EVH) and Hypertonic Saline (HS) in individuals with cough variant~     asthma (CVA) and methacholine-induced cough with normal airway sensitivity (COUGH) and~     compare these responses to a control group of healthy individuals without asthma or chronic~     cough.~      We hypothesize:~        1. EVH and HS cause dyspnea, cough, small airway obstruction with resultant dynamic~          hyperinflation, gas trapping and autoPEEP in individuals with CVA and COUGH, but not~          healthy controls.~        2. The sensory-mechanical responses to both hyperosmolar challenges (EVH and HS) are~          comparable within groups (CVA, COUGH and healthy controls).~   "
35201|NCT03105830|"~     Examine the effectiveness of an analgesic in PERFALGAN maternity latent phase of labor.~      Examine the safety in PERFALGAN in the mother and the newborn in terms of the level of drug~     in blood~   "
35202|NCT03105817|"~     In post-dilution haemodiafiltration only synthetic membranes have been used to date.~      The allergy problems described with these membranes require the development of other~     membranes capable of performing this treatment. We describe in vivo performance and behaviour~     of an asymmetric cellulose triacetate(ATA™) membrane, to identify its depurative~     effectiveness and ease of use in clinical practice, as well as evaluate its biocompatibility~     in a single haemodialysis session (acute biocompatibility) and after one month of treatment~     (chronic).~   "
35203|NCT03105804|"~     To determine the rate and amount of nicotine uptake with 10-minute ad libitum use of four~     different marketed electronic cigarettes. Furthermore, to measure overall product liking by~     subjects to assess potential willingness to seek out the Electronic Cigarette (EC) again in~     the future.~   "
35204|NCT03105791|"~     Prospective, randomized clinical trial investigating the use of patient education on~     post-operative narcotic consumption~   "
35205|NCT03105778|"~     Part 1 (POC Precision):~      Objective :~      Demonstrate that the Minicare BNP (im)precision in hands of the user is within the expected~     range of the Minicare BNP (im)precision. Part 2 (sample comparison)~      Primary objective :~      Compare Minicare BNP values from capillary whole blood from finger stick with EDTA whole~     blood from venous puncture.~      Secondary objective :~      Compare Minicare BNP values from EDTA whole blood and plasma with Li- Heparin whole blood and~     plasma from venous puncture.~   "
35206|NCT03105765|"~     Chronic Pain, especially neuropathic pain, are adverse events after posterolateral~     thoracotomy for lung resection. The continuous application of ketamine may have a~     prophylactic effect and helps to prevent chronic pain. The investigators record the incidence~     and severity of acute pain and neuropathic pain during a seven day period after thoracotomy~     as well as the incidence of chronic pain and neuropathic pain after one and three month~     period. Parallel Group design, comparing one Group with a continuous application (24 hours)~     of ketamine against a Placebo Group.~   "
35207|NCT03105752|"~     Prior to the completion of biomedical research, any person undergoing it must receive a~     readable and intelligible information about this research, in order to give free and informed~     consent. The willingness to inform patients of all risks and constraints related to research~     may be in contradiction with the need to write informative and concise documents that are~     understandable to research participants. As a result, consent forms are long, contain a lot~     of information and are complicated to understand.~      The objective of this study is to evaluate the impact of the readability of the information~     and consent forms on the understanding of the information received by participants in~     clinical trials.~   "
37234|NCT03079258|"~     The aim of this study is to determine the effect of aerobic exercise on maternal and~     offspring vascular health.~   "
35209|NCT03105726|"~     End-stage heart failure (ESHF) represents a major burden in terms of quality of life,~     mortality and costs. The current practice in France is to treat patients with ESHF by a~     combination of drugs and lifestyle interventions before proposing heart transplant (HT) if~     there is no contraindication. In the Heart and Diabetes Center of Bad Oyenhausen (BO) in~     Germany, patients presenting with ESHF are preferentially managed by ventricular assist~     device (VAD) therapy. The primary purpose of this study was to compare the outcomes of these~     two strategies in the management of ESHF and associated consumption of resources.~   "
35210|NCT03105713|"~     This study develop safety checklists for patients to use before, under and after in-hospital~     surgery. Patients and Healthcare personnel experiences and risk assesment are used to develop~     the checklists. The checklist intervention will be sequentially rolled out in a randomized~     order.~   "
35211|NCT03105700|"~     The purpose of this study is to determine if low-frequency transcranial magnetic stimulation~     (TMS) is safe and feasible for treating depressive symptoms in patients with temporal lobe~     epilepsy. Patients will receive an accelerated protocol of TMS consisting of three~     consecutive days of treatment. Patients will have two in-person follow up visits after one~     month and again after six months.~   "
35212|NCT03105687|"~     By conducting the SPPA trial we try to find out, whether personalized Short Message Service~     (SMS) reminders of blood pressure-lowering medication can effectively increase patients'~     adherence to blood pressure-lowering medication. Additionally, we also evaluate their effect~     on patients' systolic blood pressure control.~   "
35213|NCT03105674|"~     The primary aim is to test the magnitude and duration of analgesia provided by single dose~     multi-drug analgesia administered for perianal block, and compare with standard solution~     (Marcaine & Lidocaine in 1:1 mixture - Total 60 ml), at post-operative period and also to~     compare with the standard solution including their respective post-operative opioid or~     non-opioid oral analgesic requirement. Local anesthesia via a perianal block using multi-drug~     analgesia or standard solution will be compared using the Numeric pain rating scale on~     Post-operative day 1, 3 and during follow up visit on day 7. The investigators hope to find a~     better control of post-operative analgesia which will lead to better functional outcomes.~     Possible decrease consumption of opioids in the post-operative period will perhaps decrease~     the cost and chances of addiction and will increase patient comfort and compliance.~   "
35214|NCT03105661|"~     To determine if the use of impedance cardiography can identify appropriate medications for~     use in treating morbidly obese patients to decrease the risk of preeclampsia.~   "
35215|NCT03105648|"~     The prevalence of thyroid nodule is worldwide high. About 40% of normal population has~     thyroid nodules and about 5% are malignancy. It is important to differentiate malignancy from~     benign nodules because the management is completely different. Nowadays, the gold standard is~     fine needle aspiration cytology (FNAC) examination. The overall sensitivity and specificity~     is fair (~90%), but still has its limitation that some results are indeterminate in about 15%~     of the nodules. These obstacles are especially troublesome for papillary and follicular~     thyroid cancer that leads to delayed diagnosis, incomplete resection, and repeated operation.~     Preoperative evaluation of the prognosis is extraordinary important for cancer management.~     However, current prognostic scoring systems is only applicable after surgery. Hence, we~     urgently need a better risk-stratification system for individual-tailored treatment, and~     genetic-based computerized morphometry study seems to be the most realistic and promising~     one. The goal of this study is to propose a reliable method for diagnosis and prognosis of~     papillary thyroid cancer and follicular thyroid cancer through analyzing cellular morphologic~     characteristics.~   "
35216|NCT03105635|"~     Some people living with health problems require extra support to properly manage their~     conditions, as family doctors are only able to spend limited time in the office with these~     patients. There are many resources and programs in the community that can provide the~     necessary time and support for these patients, yet many patients are unaware that such~     resources exist. Patient navigators have been shown to be useful in helping patients with~     certain conditions (such as cancer) to get to the resources they need, especially when they~     have social challenges that make it difficult for them to reach these programs (for example,~     language or transportation barriers, poverty, or poor social support). This study will look~     at how helpful Navigators are to link patients at family doctors' offices to community~     resources. To do this, family doctors' offices in Ottawa will be recruited. All offices will~     receive training on referring patients to community resources, and half of these~     (intervention) will have a Navigator assigned to the practice. This study will assess whether~     access to a Navigator increases patients' access to community social and health services. In~     addition, the study aims to understand whether English and French speaking individuals are as~     likely to benefit from a Navigator in accessing community health and social services in the~     language of their choice.~   "
35217|NCT03105622|"~     OBJECTIVE AND HYPOTHESIS:~      The objective of this study will be to examine the effects of watching a screen or listening~     to music while exercising on acute energy intake and expenditure. It is hypothesized that the~     post-exercise energy compensation will be greater in both conditions with stimuli (i.e.,~     screen and music) compared with the control condition (i.e., exercise alone).~      STUDY DESIGN:~      Randomized, 3-condition crossover study (within-subjects experimental design).~      PARTICIPANTS:~      The present study will recruit 25 male adolescents between the ages of 13 and 17 years.~     Participants will be recruited via advertisements and word of mouth (first come first served~     approach).~      OVERVIEW OF THE STUDY PROTOCOL:~      Preliminary Visit The participants will attend one baseline session and three experimental~     sessions. The preliminary visit will include measurements related to anthropometry (body~     weight, height, waist circumference) and resting metabolic rate. Participants will also~     complete questionnaires in order to better characterize them.~      Experimental Sessions Each participant will be engaged in each of the following three 30-min~     experimental conditions followed by an ad libitum lunch: (1) walking/jogging on a treadmill~     at 60% of VO2 peak while watching a screen (exercise + screen); (2) walking/jogging on a~     treadmill at 60% of VO2 peak while listening to music (exercise + music); and (3)~     walking/jogging on a treadmill at 60% of VO2 peak with no other stimulus (control condition).~      MEASUREMENTS:~      The main measures for this study include: anthropometric measurements, food intake, appetite~     sensations, energy expenditure, resting metabolic rate, and ratings of perceived exertion.~      OUTCOME MEASURES:~      The primary outcome measure will be post-exercise energy compensation. The food intake~     outcome will be assessed by using an ad libitum test meal immediately after the conditions~     and a dietary record for the remainder of the day. The energy expenditure outcome will be~     assessed by using an Actical accelerometer until bedtime. The secondary outcome measures will~     include appetite sensations and the ratings of perceived exertion (OMNI scale).~   "
35218|NCT03105609|"~     Clinical trial investigating the role of hyperspectral imaging in the management of patients~     undergoing standard clinical treatment for naive neovascular choroidal membranes in~     age-related macular degeneration.~   "
35219|NCT03105596|"~     This is a prospective phase II clinical trial to observe the efficacy and safety of Chidamide~     combined with DICE (Dexamethasone, Ifosfamide, Cisplatin and Etoposide) in patients with~     relapsed or refractory B-cell Non-Hodgkin's Lymphoma (NHL).~   "
35220|NCT03105583|"~     This cross-sectional study will try to give answers to the following project aims:~        -  To provide an overview of the prevalence of health products' use among Belgian pregnant~          women (prescription and OTC medication, vitamin supplements, phyto-therapeutics,~          dermatologic products), including where pregnant women buy or get their health products~          (online web survey).~        -  To document women's beliefs about medication during pregnancy and their information~          desire (online web survey).~        -  To determine the current vitamin status among pregnant women and to reveal clinical~          targets for supplementing deficiencies in this population (blood sample analysis).~      The study will be performed at the obstetrics department of the University Hospitals of~     Leuven (campus Gasthuisberg).~      We aim to include 300 pregnant women (100 per trimester), of which 150 women will be asked to~     determine their vitamin status (50 per trimester).~   "
35221|NCT03105570|"~     To balance the oncological safety and cosmetic outcome is the basic principle of modern~     breast surgery. To preserve the nipple-areolar complex shows attractive cosmetic advantage~     but concerns regarding local recurrence make the oncological safety of nipple sparing~     mastectomy a controversial issue. Since the involvement of areolar pigmented skin by cancer~     is rare compared to that of nipple, we designed the current study to investigate the~     oncological safety and cosmetic outcome of Areola Sparing Mastectomy.~   "
35222|NCT03105557|"~     On a daily basis many (prematurely born) newborn are subjected to different urine collecting~     techniques to study biochemical abnormalities. Neonatology nurses and pediatricians are~     looking for a better and less invasive manner to collect urine in these vulnerable patients.~     We hypothesise that the urine collecting device as presented in this protocol is less~     invasive and has good functional abilities to collect urine in these newborns~      Objective of the study:~      Clinical feasibility of the urine collection device, indicated by staff and parents.~      Study design:~      The study will be an open label, clinical feasibility study, of the urine collection device.~     During a period of 6 months, 30 feasibility tests will be performed.~      Study population:~      Prematurely born newborns, admitted to the neonatology unit of the department of pediatrics~     at Rijnstate Hospital Arnhem.~   "
35223|NCT03105544|"~     Detection of growth restricted fetuses relies primarily on abdominal ultrasound examinations~     during pregnancy. Many clinicians, however, have not received systematic training and may~     therefore perform inadequately. We wish to examine, whether systematic, simulation-based~     training can improve diagnostic accuracy of estimated fetal weight by ultrasound at different~     levels of clinical experience.~   "
35224|NCT03105531|"~     Primary aldosteronism (PA) is an under-diagnosed cause of arterial hypertension.~     Cardiovascular morbidity and mortality in hypertension rises significantly for patients who~     have aldosterone overproduction when compared with those with primary hypertension and the~     same level of blod pressure elevation. The classical signs of PA such as severe hypertension~     and hypokalemia may be absent, why screening in defined risk groups has been recommended.~     Screening has not been systematically implemented in Sweden, probably due to expensive, time~     and effort-consuming clinical routine protocols and low awareness of the problem among~     clinicians. The prevalence of PA in patients with hypertension in Sweden has not been studied~     adequately, and few studies from Northern Europe have addressed the problem.~      The primary objective is to investigate prevalence of PA among patients with hypertension in~     primary care and to implement and assess optimal treatment. Discovered cases of PA will go~     through routine clinical work-up in order to distinguish the subtype of PA, which includes~     computed tomography of adrenals and adrenal vein sampling (AVS) in those willing and fit for~     surgical treatment. Treatment will be then chosen depending on the PA subtype. Those with~     unilateral disease who are willing and fit for surgery will be offered unilateral minimally~     invasive adrenalectomy. Patients who oppose or have contraindications to operative treatment,~     as well as patients with bilateral disease will be offered medical treatment with~     mineralocorticoid receptor antagonists (MRA).~      Study participants will be then followed up one year after surgery or initiation of specific~     medical treatment. Please se outcome measures for relevant description of those.~      Blood samples will be collected from patients with confirmed PA to be stored in a biobank for~     potential future genetical and biochemical studies. A subgroup of patients with PA will~     undergo adrenal-specific positron-emission tomography to assess the possibility to~     un-invasively diagnose and subtype PA.~   "
35225|NCT03105518|"~     The central objective of this study will be to evaluate the relationship between estrogen~     levels and the pain following oocyte retrieval in women undergoing in vitro fertilization.~   "
35226|NCT03105505|"~     The study aims to investigate the effect of Permethrin 5% treatment on Signs and symptoms of~     Demodex-blepharitis in comparison to Synthomycine 5% and Fucithalmic (fusidic acid 1%) .~   "
35227|NCT03105492|"~     Background:~      Prenatal whole genome sequencing (PWGS) will give expecting parents large amounts of genetic~     data about their baby. This raises ethical concerns. Researchers want to find out if women~     want access to the kind of data PWGS provides. They want to know why and under what~     circumstances women would or would not want the data.~      Objective:~      To explore the views of pregnant women about possible use of PWGS. To find out whether they~     would want different categories of genetic data, and how they would use such findings.~      Eligibility:~      Women ages 18 and older who pregnant and speak English or Spanish~      Design:~      Participants will be recruited by their doctors.~      Participants will take a survey about their views of PWGQ. They may take it online or on~     paper.~   "
35228|NCT03105479|"~     Cadazolid has demonstrated activity against a bacteria named Clostridium difficile in animal~     studies. The results of a first study conducted in adult patients have suggested efficacy of~     the new antibiotic, cadazolid, in the treatment of diarrhea caused by this bacteria. This is~     the first study of cadazolid in children. The overall purpose of this study is to provide~     reassurance on the safety and efficacy of cadazolid in children suffering from infection due~     to Clostridium difficile.~   "
35239|NCT03105336|"~     This study will enroll approximately 50 adult subjects who have relapsed or refractory (r/r)~     iNHL to be infused with the study treatment, axicabtagene ciloleucel, to see if their disease~     responds to this experimental product and if this product is safe. Axicabtagene ciloleucel is~     made from the subjects own white blood cells which are genetically modified and grown to~     fight cancer. An objective response rate of 70% is targeted.~   "
35240|NCT03105323|"~     This study will be conducted at the In vitro fertilization Unit at Ain Shams University~     Maternity Hospital.~      Women will be recruited from the In vitro fertilization Unit who will fulfill the inclusion~     criteria. They will be counseled to be included into the study The study will assess Role of~     Ratio of Progesterone to Number of Follicles as a Prognostic Tool for Intracytoplasmic Sperm~     Injection outcome.~   "
35241|NCT03105310|"~     Ezetimibe possesses pharmacophore features to inhibit NTCP, the receptor required for HBV and~     HDV hepatocyte entry, that include two hydrophobes and one hydrogen bond acceptor.~      The aim of the study io evaluate the utility of Ezetimibe in combination with pegylated~     interferon in patients with chronic HDV infection.~   "
35229|NCT03105466|"~     The performance of keratoplasty is hampered by the limited availability of donor cornea in~     many countries, especially in Asia. For this reason, attempts have been made to fabricate~     artificial substitutes for natural human cornea. So far, all polymeric biomaterials, such as~     collagen configurations and plastic compression, could mimic the functional optically~     transparent but failed to replicate the complicate three-dimension microstructure of natural~     cornea. Therefore, despite some favorable results yielded by polymeric biomaterials, they~     cannot be suited for long-term use. To overcome these disadvantages, in recent years, porcine~     cornea appeared specifically attractive for xenotransplantation, because of its accessibility~     and similarities to natural human cornea. However, xenotransplantation using fresh porcine~     cornea can occurs hyperacute immune rejection, resulting in graft failure. Such transplant~     rejection can be substantially lessened by using acellular porcine cornea (APC), which~     preserves the constructure of natural cornea, whilst having well biocompatibility and low~     antigenicity. These properties feature APC particularly suitable for high-risk keratoplasty,~     such as corneal grafting in infectious keratitis.~      Use of APC in LK has been shown promise in many preclinical animal studies and initially in~     human clinic trail. However, to optimize APC biological and biomechanical properties, the~     strategies for its preparation has evolved extensively over recent years, like various~     decellularization approaches (e.g. detergents, enzymes, human sera, hypertonic solutions and~     et al) and additional procedures (e.g. collagen re-crosslinking and repeated frozen-dry).~     Therefore, in the current study, the investigators analyzed the early surgical outcomes of~     deep anterior lamellar keratoplasty (DALK) using the APC that was very recently approved by~     the National Institutes for Food and Drug Control (NIFDC) of China for clinic practice, for~     management of infective keratitis, including fungal, viral and acanthamoeba keratitis. Here~     major concern of this study was to clarify the behavior of APC after implantation in~     participants.~   "
35230|NCT03105453|"~     To assess the impact of the female genital microbiome on ART outcome.~   "
35231|NCT03105440|"~     The aim of this study is to evaluate the effects and validate news physiotherapy techniques:~     robotic rehabilitation, virtual reality, vibration therapy, canoeing and hand cycling in the~     secondary clinical complications of the breast cancer, through the Biomedical~     Instrumentation. It will be realized the double-blind longitudinal clinical study. Will~     participate in the study 100 women post breast cancer surgery, the volunteers will be~     allocated in the respective modalities treatment; and 20 healthy volunteers, will be only the~     control group. The volunteers conducted 10 physiotherapy session, and it will be evaluated~     after, during and before of the treatment, to evaluated myoelectric activity, scapular and~     hand muscle strength, range of motion, circumference of the upper limbs and quality of life.~     Expected to Positive Results With regard to the minimization of pain intensity and~     lymphedema, favoring the improvement of range of motion of the shoulder joint, myoelectric~     activity, increased muscle strength, and consequently improves the quality of life.~   "
35232|NCT03105427|"~     The potential use of regulatory T cells as preoperative risk stratification tool is evaluated~     in order to improve clinical risk stratification and reduce perioperative morbidity and~     mortality.~   "
35233|NCT03105414|"~     Rationale : ventilator associated pneumonia (VAP) has been extensively studied in adults,~     however, few data exist regarding VAP in the paediatric intensive care population. The~     Centers for Disease Control (CDC) definition for VAP is regularly updated trying to~     homogenised practice, and the last version for paediatrics has been published in 2015.~     According to the latest CDC definition, the investigators aim to study incidence of VAP in~     different paediatric intensive care units (PICUs), diagnostic methods of identifying VAP,~     microbiology of VAP, and utilisation of empirical antimicrobial therapy.~      Methods and population : a prospective multicentre observational study will be conducted in~     European PICUs for one year. All patients admitted to PICU aged more than 28 days and < 18~     years, mechanically ventilated either by endotracheal or tracheostomy tube are included.~     Clinical data, ventilation settings, and risk factors for VAP are inserted daily in an~     electronic database on the internet. The investigators are going to identify patients, who~     presented one or more episodes of VAP during PICUs stay, analysing onset circumstances,~     diagnostic methods, bacteria pathogens identified, and antibiotic treatment. VAP incidence~     will be reported as number of events per 1,000 ventilator-days. Risk factors associated to~     VAP will be identified by univariate and multivariate analysis.~      Results and perspective : the investigators aim to define for the first time the incidence of~     VAP among European PICUs with a prospective and multicentre study. The identification of risk~     factors, diagnostic methods, epidemiology, treatment strategies will define the basis to~     start prevention manoeuvres and improve the clinical strategies for VAP in paediatric~     intensive care population.~   "
35234|NCT03105401|"~     This study aims to describe hallucinations prevalence in a sample of patients affected by~     Parkinson's disease and consulting in an outpatient facility.~      An unique one hour interview will be offered to volunteers patients. Patients participating~     to the study will be asked to answer a semi-structured questionnaire searching for~     hallucinations of all modalities, minor psychotic symptoms and delusions. Psychometric scales~     will be assessed to search for depressive symptoms, cognitive impairment and specific~     personality characteristics.~      The study hypothesis is that hallucinations prevalence in Parkinson's disease is~     underestimated and is higher than usually described in the scientific literature when all~     hallucinations modalities and minor hallucinatory phenomenons are searched for.~   "
35235|NCT03105388|"~     Incidence of difficult laryngoscopy and difficult intubation are higher among patients with~     obstructive sleep apnoea (OSA). Precision in making the diagnosis and predicting difficult~     laryngoscopy preoperatively may help to reduce anesthetic complications. This study was~     designed to evaluate the diagnostic performance of combined and non-combined radiological~     parameter (mandibulohyoid distance) and STOP-BANG questionnaire as screening tool.~      Methodology:~      Forty-one subjects who were at risk of OSA, undergoing general anaesthesia will be included~     using STOP-BANG questionnaire. Mandibulohyoid distance and other radiological parameters will~     be measured from lateral cephalometry. Evaluation for difficult laryngoscopy will be carried~     out during anaesthesia.~   "
35236|NCT03105375|"~     The purpose of this study is to assess and analyze the safety, tolerability and PK/PD data~     following single ascending and multiple ascending doses of X842 in healthy subjects.~   "
35237|NCT03105362|"~     This study will assess the tolerability and palatability of an amino acid based oral~     rehydration solution (enterade®) compared to current oral rehydration solution among children~     with short bowel syndrome .~   "
35238|NCT03105349|"~     This is a phase 4 clinical trial to treat patients who have failed to treat with regimen~     based on an inhibitor of the NS5A~   "
35242|NCT03105297|"~     To characterize the performance of the nasal dilator strip in lowering nasal resistance~     during sleep, promoting nasal route breathing and reducing the signs and symptoms of sleep~     disordered breathing in a group of chronic nocturnal nasal congestion sufferers who report~     trouble with their sleep.~   "
35245|NCT03105245|"~     This study will examine how anaesthetic technique affects ECT outcomes. Specifically, the~     investigators will examine how: 1) the time interval between anaesthetic and ECT stimulus,~     and 2) the ventilation rate before ECT stimulus, impacts on the quality of the EEG (this is a~     recording of brain activity during ECT and is used to judge the quality of a seizure and to~     guide individual patient dosing).~   "
35246|NCT03105232|"~     Side effects of opioids can from practical view be divided into short-term and long-term.~     Nervous system disorders are manifested by psychological status changes of the patient and~     may cause confusion, mental and somatic dependency, dizziness and so on. Influencing the~     vegetative and cardiovascular system hypotension can occur what is manifestation of~     vasodilation and decreased myocardial inotropic activity. Another clinical sign is~     bradycardia and is characterized by general weakness, sweating, collapse can develop. Effects~     of opioids may cause respiratory depression, bronchospasm and bronchoconstriction. Side~     effects on the gastrointestinal tract are nausea, vomiting, constipation and less frequently~     dry mouth. The constipation does not develop tolerance and has to be avoided (dietary~     modification, laxatives prevention) respectively during long-term opioid treatment~     obstipation should be affected by blocking peripheral opioid receptors in the~     gastrointestinal tract by application of an opioid antagonist methylnaltrexone, which does~     not cross the blood brain barrier, or using naloxone, which is metabolized by first-pass~     metabolism in the liver for example combined preparation containing oxycodone and naloxone~     (Kulichová, 2012). Known side effects on parenchymatous organ especially on liver is~     restricted biliary excretion caused by spasm of the biliary tract. Skin manifestations caused~     by the effects of opioids are urticaria, dermatitis, and pruritus. Renal and urinary~     disorders may develop as urinary retention and ureteral spasm. Rarely can occur disorders of~     the immune system, which through the development of hypersensitivity may lead to the~     development of anaphylactic shock (Kulichová, 2012). Opioids have a negative effect and the~     endocrine system. Various studies have demonstrated the influence of opioids on regulatory~     mechanisms. Fundamental changes occur in hypothalamic-pituitary complex, which directs the~     activities of all the endocrine system. Secretion of hormones of the pituitary gland~     regulates the nervous system through the hypothalamus, which is the coordination center of~     autonomic function. The pituitary gland has coordinating function in relation to other~     endocrine glands, and by production of their hormones affects the peripheral endocrine organs~     and the targeting tissues (Kulichová, 2012), (Colameco, 2009).~      Opioids decrease the secretion of gonadotropin-stimulating hormone, resulting in reduced~     levels of luteinizing hormone. The result of these changes is reduced secretion of~     testosterone and estradiol what results in symptoms of hypogonadism. Chronic administration~     of exogenous opioids decreases the levels of adrenocorticotropic hormone and cortisol, as~     well as their circadian rhythms. The result is a reduction in the response to stress. Effect~     on prolactin is not entirely clear. Opioids can stimulate the hypothalamus through the~     thyroid stimulating hormone, which may cause prolonged and increased response to opioids in~     patients with hypothyroidism. Chronic use of opioids is associated with weight gain,~     hyperglycemia and diabetes can worsen (Kulichová, 2012). It may be related to central effects~     through the sympathetic nervous system and impaired insulin secretion. New laboratory~     measurements show the development of oxidative stress in patients receiving morphine and~     related drugs (Merdin, 2016).~      The consequences of these biochemical changes further negatively affect the clinical outcome~     of the patients. They may become predisposed to excessive progression of previously latent~     diseases whose manifestations in patients previously were not apparent and there is emergence~     of new diseases. The present data are essential to create a clinical prospective~     observational studies to clarify this issue and its conclusions would be essential for new~     therapeutic options for adjuvant therapy in patients suffering from chronic pain.~   "
35247|NCT03105219|"~     To explore the efficacy of Ivabradine for the treatment of microalbuminuria in patients with~     type 2 diabetes and coronary heart disease.~   "
35248|NCT03105206|"~     This study centers on the treatment of low pole renal stones by flexible ureteroscope and~     intends to find the key anatomical parameters using a prospective, randomized multi-center~     trial design and to make a more appropriate standard for flexible ureteroscopy of low pole~     renal stones.~   "
35249|NCT03105193|"~     The aim of this study is to investigate the analgesic effects of intraperitoneal lignocaine~     (IPL) compared with intravenous lignocaine (IVL) after laparoscopic colon resections. We plan~     to run a 2 group randomized, double blind, clinical trial which will look into morphine~     consumption as the primary outcome.~      Group 1 (IV lignocaine)- IV bolus of lignocaine and a 3 day post operative IV lignocaine~     infusion. Intra peritoneal (IP) bolus of normal saline + 3 day post operative IP normal~     saline infusion~      Group 2 (IP lignocaine)- IV bolus of normal saline and a 3 day post operative IV normal~     saline infusion. IP bolus of lignocaine + 3 post operative IP lignocaine infusion~   "
35250|NCT03105180|"~     Irrigating fluid absorbed during the endoscopic surgery may alter whole blood coagulation.~     However, little is known about the dose-response relationships of hemodilution. The~     investigators have therefore performed the present study to measure the effect of a mixture~     of 2.7% sorbitol-0.54% mannitol solution on the coagulation pathway according to the~     hemodilution level using a rotational thromboelastometry (ROTEM®) tests.~   "
35251|NCT03105167|"~     Transforaminal lumbar interbody fusion (TLIF) had been favorable for effectively decrease~     pain and disability in specific spinal disorders; however, there has been concern regarding~     pedicle screw placement during TLIF surgery. Recently, several biomechanical studies had~     demonstrated that CBT technique achieves screw purchase and strength equivalent to or greater~     than the traditional method. Furthermore, Only 1 report examined the surgical outcomes of~     TLIF with CBT screws fixation compared with TLIF using traditional pedicle screws fixation.~     TLIF with CBT screws fixation may be effective for specific spinal disorders, but the~     evidence supporting this possibility is still limited.~   "
35252|NCT03105154|"~     Evaluate wound healing using Prevena compared to standard dressings in high risk patients~     after vascular surgery.~   "
35253|NCT03105141|"~     This prospective, randomized, single-center clinical trial is designed to figure out the most~     optimal algorithm of remote ischemic conditioning on patients with chronic cerebral ischemia.~   "
35254|NCT03105128|"~     The purpose of this study is to evaluate the efficacy and safety of risankizumab versus~     placebo during induction therapy in subjects with moderately to severely active Crohn's~     disease (CD).~   "
35255|NCT03105115|"~     Intravenous infusion of dexmedetomidine during procedure was known to be associated prolonged~     duration of spinal anesthesia. In patients receiving dexmedetomidine infusion during~     procedure, it has been not evaluated whether use of adjuvant intrathecal fentanyl had~     additional prolonging effect on duration of spinal anesthesia or not. Therefore, the~     investigators planned this trial to compare clinical outcomes in patients receiving spinal~     anesthesia with heavy bupivacaine only and heavy bupivacaine plus fentanyl adjuvant.~   "
35256|NCT03105102|"~     The study consists of 3 sub-studies, as follows:~        -  Sub-study 1 (Randomized, double-blind, placebo controlled study) to evaluate the~          efficacy and safety of risankizumab versus placebo as maintenance therapy in subjects~          with moderately to severely active Crohn's disease (CD) who responded to risankizumab~          induction treatment in Study M16-006 or Study M15-991~        -  Sub-study 2 (Randomized, exploratory maintenance study) to evaluate the efficacy and~          safety of two different dosing regimens for risankizumab as maintenance therapy in~          subjects who responded to induction treatment in Study M16-006 or Study M15-991;~        -  Sub-study 3 (Open-label, long-term extension study) to evaluate long-term safety of~          risankizumab in subjects who completed Sub-study 1 or 2.~   "
35257|NCT03105089|"~     preconditioning of no debate has a valuable effect upon myocardial protection .~     pre-cardiopulmonary bypass pre-conditioning , suspected to have a role upon postoperative~     inotropic support~   "
35258|NCT03105076|"~     Both simple mastectomy and breast conservation therapy (BCT) with radiotherapy yield similar~     survival rates in breast cancer. These two treatment strategies have diverted cosmetic~     outcome and convenience. Thus, shared decision making (SDM) is necessary to aid patients to~     choose an appropriate treatment that suits thier needs. We have developed a decision aids~     (DAs) and plan to conduct a randomized controlled trial (RCT) to evaluate its impact on~     cancer patients. The measurements include a battery of interview-based questionnaires and~     evaluations of decision regret and postsurgical depression. We expect the DAs would benefit~     the intervention group in the aspects of knowledge, communication and anxiety status during~     and after thier treatment sessions.~   "
35259|NCT03105063|"~     The anatomy of the acetabulum is well described in the past literature, yet the understanding~     of the clinical importance of the anatomical morphology of the AIIS has grown in recent~     years. Hetsroni et al. (2013) proposed a morphological classification of AIIS. In this~     classification, three types AIIS are identified based on the relationship between the distal~     extension of the acetabular rim and the AIIS. Unfortunately classifying the morphology of the~     AIIS using standard AP pelvis examination is misleading and requires additional imagery, a~     specific radiographic projection - false profile pelvis or 3d imaging techniques such as CT~     or MRI.~      The objective of this study is to evaluate AIIS morphology using ultrasound as compared to~     golden standard (MRI)~   "
35270|NCT03104920|"~     The worldwide introduction of multimodal enhanced recovery programs has also changed~     perioperative care in patients who undergo liver resection. This study will be performed to~     assess a comprehensive care package for patients with hepatocellular carcinoma (HCC)~     undergoing hepatectomy with the aim of minimal physiological disturbance in the~     peri-operative period. Peri-operative opioid-sparing analgesia with few gastrointestinal (GI)~     effects and reduced requirement for intravenous fluid therapy, early ambulation and promoted~     GI function recovery were centered to this plan.~   "
35260|NCT03105050|"~     In recent years more and more collaboration between hospitals performing bariatric surgery~     occur and more exchange of knowledge on pre and postoperative care is shared. Different~     countries have many different protocols to select and guide patients through bariatric~     surgery, and even within countries differences exist. These are most commonly based on expert~     opinions and cultural influences. Although many outcomes of the different approaches are~     known, the pathways the patient has to take and the accessibility to bariatric surgery are~     unclear for each country as well as how the care for these patients is financially arranged.~     As a progressive research collaboration, we would like to gain more insight into these~     different approaches. With this study we would like to gain more insight into the~     accessibility and restrictions to accessibility to both bariatric surgery and body contouring~     surgery after massive weight loss that exists in all 51 European countries, as well as why~     this disparity exists.~   "
35261|NCT03105037|"~     Prospective, observational, non-interventional study that will examine if the insertion of a~     Supraglottic airway will increase accuracy of identifying the cricothyroid membrane~   "
35262|NCT03105024|"~     Self-efficacy refers to the perceived belief to cope effectively, by personal efforts, with~     challenging situations and problems (Bandura, 1977). Basic research has shown that increases~     in perceived self-efficacy can enhance the extinction of fear (Zlomuzica et al., 2015). This~     study is aimed at translating these findings into a useful clinical application to augment~     exposure-based treatment outcome.~   "
35263|NCT03105011|"~     This study is designed to see if rural patients with type II diabetes interacting with their~     clinic staff by providing daily updates of blood glucose levels will improve glucose control.~   "
35264|NCT03104998|"~     To study the effect of coenzyme Q10 on semen parameters in men with idiopathic infertility~   "
35265|NCT03104985|"~     The aim of this study was to evaluate comparatively the efficiency of traditional treatment~     methods in patients with chronic venous diseases of C6 class, and a new combined low level~     laser therapy (LLLT) by LASMIK device.~      The results of outpatient examination and treatment of patients with venous trophic ulcers,~     observed in the City Polyclinic of Tula Municipal Clinical Hospital №2 were analyzed.~   "
35266|NCT03104972|"~     The possibility of influencing brain activity and steadily enhancing behavioral performance~     through external intervention has long fascinated neuroscientists. One of these techniques,~     transcranial electrical stimulation (tES), has received great interest. Transcranial~     electrical stimulation (tES) in the current research includes two types of stimulation:~     transcranial direct current stimulation (tDCS) and transcranial random noise stimulation~     (tRNS).~      The tES techniques involve the application of constant weak direct current (e.g. 1-2 mA) to~     the brain via skin-electrode interface, creating electric field that modulates neuronal~     activity. The safety profile of tES is excellent.~      Despite effective pharmacotherapy for ADHD there is a need for improvement of cognitive~     dysfunction and behavioral symptoms that are only inadequately covered by pharmacological or~     psycho-social interventions. Since ADHD is the most common neurodevelopmental disorder in~     childhood with significant negative lifetime outcomes, non-invasive brain stimulation methods~     have been investigated in childhood and adolescents neuropsychiatric disorders showing~     promising results.~      If tES is significantly effective for certain symptoms of ADHD, it may offer many advantages~     as a therapy. Treatment of ADHD with non-invasive brain stimulation has recently been~     reviewed in the medical literature, concluding that this technique seems to have efficacy in~     ADHD, however, standardized study protocols are needed to determine it.~      In this study we intend to further examine the efficacy of tDCS and tRNS for children with~     ADHD and its effect on ADHD symptoms, memory, executive functions, in a randomized controlled~     crossover study.~   "
35267|NCT03104959|"~     This is a double-blinded study involving healthy non-alcoholic (self-reported) volunteers~     over the age of 21. Consent is obtained prior to participation in the study while the~     participant is sober. Volunteers are recruited from residency programs, hospital employees,~     emergency medical personnel, and friends of the study investigators. If the volunteers choose~     to drink, they can participate in the study the night of ingestion of alcohol. There is no~     amount we ask them to drink, and we allow them to withdraw from the study at any time. We~     never force them to drink alcohol, or even encourage it. The participation is completely~     voluntary, if they would like to participate and if they choose to drink alcohol, we ask them~     to participate in the placebo controlled study in the safety of their own home. Then~     materials for the study are given out prior to their participation. An envelope is given with~     the questionnaire, and a small packet containing 3 pills of either NAC or placebo, and a~     small smear of Vicks vapor rub concealed in a small packet. At the end of their alcohol~     ingestion, the volunteer is asked to estimate the number roof drinks consumed and take 1~     capsule per 3 drinks consumed of either 600 mg N-Acetyl-L-Cysteine or placebo capsules. In~     the morning, each participant fills out a Hangover Symptom Score questionnaire . A random~     number generator is used to determine placebo or NAC first, then the participant is given the~     other treatment at their subsequent encounter. Then study is being conducted over a series of~     many months, and data can be analyzed by the hangover symptoms scale data when using NAC~     compared to placebo. The data will be analyzed using the numerical values of each category~     for hangover classification and compare the placebo data to the control data.~   "
35268|NCT03104946|"~     From November 2014 to October 2015, a multi-centers retrospective study was conducted to~     collect compliance, and 8 three-level hospitals from China were included. The infants~     survived to a postmenstrual age of 36 week with birth weight less than 1500g and without~     congenital disease. The birth weight, gestational age, morbidities and poor outcomes( death,~     cerebral palsy, cognitive, et al) were recorded. Data were analyzed with Chi-square test to~     observe the relationship between morbidities and poor outcomes. And the predictive effect on~     the number of the top three morbidities were analyzed by Logistic regression analysis.~   "
35269|NCT03104933|"~     This study evaluates the usefulness of pro-adrenomedullin (precursor of a vasodilatory~     peptide involved in septic shock pathogenesis) and copeptin (a stable peptide of the arginine~     vasopressin precursor) to predict, at the moment of septic shock diagnosis or their changes~     at 6 hours, the vasopressor requirements (measured by inotropic index and vasopressor~     dependency ratio) and volume requirement for resuscitation.~   "
37235|NCT03079245|"~     To determine if 3 randomly assigned bundles of stewardship interventions would reduce overall~     and inappropriate antimicrobial use in the neonatal intensive care unit (NICU), a pre-post~     study was performed in 4 NICUs.~   "
35272|NCT03104894|"~     The study aims to investigate whether combined treatment of MGD massage and artificial tears~     will improve signs and symptoms of dry eye compared to artificial tears alone.~      The meibomian glands secrete meibum which is the oily component of the tear film layer. The~     meibum plays a pivotal role in preventing tear evaporation and smoothening the tears film .~      Meibomian gland dysfunction is a common condition that affects 39%-50% of the population. It~     is part of inflammatory disease of the eyelids called blepharitis. Associated syndromes are~     rosacea and dry eye syndrome .~      Sign and symptoms are: irritation, hyperemia, burning sensation, photophobia, epiphora and~     blur.~      Spectrometry analysis shows change it the fatty acids conformation such as increase in levels~     of branched-chain fatty acids and decrease in saturated fatty acids .~      Subsequently the clotted meibum results in glands blockage that can be graded in 0-4 grade~     scale: grade 2- meibum secretion thick and oily, grade 3- meibum secretion~     granular-toothpaste like.~      Although MGD is not often accompanied with inflammatory signs it is a common cause for~     evaporative dry eye.~   "
35273|NCT03104881|"~     Comparisons of two types of rehabilitation robot for upper extremities: 3 dimension~     exoskeleton type upper extremity robot vs. 2 dimension end-effector type robot)~   "
35274|NCT03104868|"~     The investigators will evaluate a technology-enabled strategy designed to promote medication~     adherence, routinely monitor regimen use, and mobilize appropriate transplant center~     resources to respond early to kidney transplant recipients demonstrating inadequate~     adherence.~   "
35275|NCT03104855|"~     The goal of this study is to define 25(OH)D3 catabolism in CF patients using gold standard~     pharmacokinetics studies. Specifically, the investigators will evaluate the metabolic~     clearance of 25(OH)D3 among participants with CF and matched control subjects. The goal of~     this work is to provide the first comprehensive characterization of vitamin D metabolism in~     CF patients and promote novel hypotheses for subsequent studies.~   "
35276|NCT03104842|"~     A Clinical Phase II, multicenter, Open-label study evaluating iNduction, consolidation and~     maintenance treatment with Isatuximab (SAR650984), Carfilzomib, LEnalidomide and~     Dexamethasone (I-KRd) in Primary diagnosed high-risk multiple myeloma paTients~   "
35277|NCT03104829|"~     This study evaluates the effect of diabetic knowledge and self care behavior (DSME) alone or~     DSME plus motivational interviewing on glycemic control among children and adolescents with~     DM type 1. Half of participants will receive DSME along, while the other half will receive~     DSME plus MI.~   "
35278|NCT03104816|"~     Simple explanation and rationale:~      Recovery after spine surgery is usually accompanied by severe pain which has traditionally~     been managed with opioids. It is common practice to supplement opioid treatment with~     different classes of analgesics which work through alternative pain pathways and receptors in~     order to achieve an additive or synergistic effect while reducing the amount of opioids~     necessary for pain control.~      Acetaminophen can be a beneficial supplemental analgesic to opioids for postoperative pain~     relief.~      Intervention:~      Patients will be randomized to either the treatment with IV acetaminophen (A), PO~     acetaminophen (B), or hydromorphone control group (C).~      Objective/Purpose:~      Primary objective is to determine the impact of administering a supplemental non-opioid~     analgesic drug such as IV or PO acetaminophen on total opioid dose administered over the~     perioperative period.~      Secondary objectives include investigating the impact of IV/PO acetaminophen on the level of~     postoperative pain, patient satisfaction, and side effects secondary to opioids such as~     nausea, vomiting, pruritus, sedation, respiratory depression, ileus, and urinary retention,~     and PACU discharge time.~      Study population:~      126 patients will be enrolled in the study (42 for group A, 42 for group B, and 42 for~     control group C).~      Follow-up and Endpoints / Outcomes:~      Postoperative assessments will be done at 0, 30, and 60 minutes, 6 hours, 12 hours and 24~     hours after surgery. Patients will be evaluated for pain (using a numeric rating scale),~     total opioid consumption, and for opioid side effects including drowsiness (using the Ramsey~     sedation scale and the Aldrete score at the time of arrival to and discharge from recovery~     room), respiratory depression, nausea, vomiting, and pruritus. Patient satisfaction will also~     be assessed using a numeric rating scale.~   "
35279|NCT03104803|"~     The investigators have recently shown in incomplete SCI patients that long-term paired~     associative stimulation is capable of restoring voluntary control over some paralyzed muscles~     and enhancing motor output in the weak muscles (1). In this study, the investigators will~     administer long-term paired associative stimulation to patients with incomplete SCI of~     non-traumatic origin.~   "
35280|NCT03104790|"~     LAIV shedding studies in children could be an important way to confirm whether impediments to~     viral replication do indeed explain these observed reductions in vaccine effectiveness(VE),~     whether prior vaccination has any influence on replication and what future implications (if~     any) this might have for the UK paediatric LAIV programme. LAIV virus replication in children~     will be dependent on virological and host factors. The virus factors include replicative~     fitness of individual strains and the susceptibility to inhibition by other replicating~     strains (ability to compete). Host factors which may influence this include pre-existing~     specific immunity as a result of prior infection or previous vaccination (with either LAIV or~     IIV), and innate immune factors including mucosal immunity. Understanding the relative~     importance of different factors over two seasons when the strain composition of the~     A/H1N1pdm09 LAIV virus will change and by comparing previously unvaccinated and highly~     vaccinated groups (with both LAIV and IIV), can potentially give unique insights into their~     contribution to the US LAIV observations.~      With the change of the A/H1N1pdm09 vaccine strain in 2017/18, demonstrating improved~     performance (in terms of VE, virus shedding and immunogenicity) and what contribution prior~     vaccination might make will be key evidence for both the UK, but also the US. Information~     presented at the ACIP in June 2018 from the 2016/17 and 2017/18 seasons will be key to inform~     US future decisions around use of LAIV.~      This is a parallel group, non randomised study which will enrol at least 400 children. Both~     written informed consent from parent/ guardian and written assent from the child will be in~     place prior to any study procedure. The two groups will be defined by previous influenza~     vaccination history, with around half the children naïve to any influenza vaccination (LAIV~     or IIV) and half having had at least three doses of LAIV with or without IIV. All will follow~     the same schedule of vaccination and oral fluid collection at day 0 (by the nurse in the home~     or at the GP surgery); nasal swab collection (by the parent at home on days 1,3,6); day 21~     oral fluid collection (by nurse or parent at home or at GP surgery).~   "
35281|NCT03104777|"~     Public Health England's (PHE) Behavioural Insights Team are leading and fully funding a~     randomised controlled research trial in collaboration with Derby City Council's Public Health~     Team and the Health and Social Care Research Centre at Derby University to test an~     intervention designed to help families provide healthier packed lunches for Primary School~     aged children.~   "
35282|NCT03104764|"~     The aim of the study was to compare the outcome in terms of wound healing time, surgery time,~     bleeding and patient experience of the ectomy of frenulum when performed with laser~     technology versus conventional scalpel technique. A prospective, single-blind, randomized and~     controlled study was performed. Wound healing was assessed five and ten days after after~     surgery. The long-term outcome were assessed blinded by a dentist not earlier involved in the~     study.~   "
35283|NCT03104751|"~     The primary goal of this study is to systematically describe early neurodevelopment using a~     complementary set of observational and neurophysiological measures that may predict cognitive~     and motor delays earlier than currently possible for infants with Complex Congenital Heart~     Disease (CCHD).~   "
35284|NCT03104738|"~     Many patients with Type 2 Diabetes Mellitus (T2DM) are currently being managed with Basal~     Insulin (BI). However, there is little evidence to support guidelines on dosing adjustments~     in the preoperative period. The Society for Ambulatory Anesthesia does not advise a reduction~     in the dose of BI preoperatively, unless there is a specific history of hypoglycemia. The~     Endocrine Society suggests a 50% reduction in BI dose the evening before surgery. The authors~     hypothesized that a 25% reduction in BI dose the evening before surgery will result in better~     perioperative blood glucose control compared with our institutional 50% decrease.~   "
35285|NCT03104725|"~     Background:~      Parkinson s disease (PD) causes slow movement, stiffness, and poor balance. Many symptoms are~     due to the loss of brain cells that make the brain chemical dopamine. The cells may be~     damaged by the breakdown of dopamine by a process called oxidation. The drug N-acetylcysteine~     (NAC) can act as an antioxidant. Researchers want to test if NAC can decrease the oxidation~     of brain dopamine in people with PD.~      Objective:~      To look at the effect of NAC on brain chemistry in people with PD.~      Eligibility:~      People ages 18 and older with PD that was diagnosed within the past 5 years. They must be~     taking a monoamine oxidase inhibitor.~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Blood and urine tests~      Participants will be hospitalized for 4 to 8 days.~      On day 1, they will have blood and urine tests. They cannot eat or drink anything but water~     and their medications for several hours. Late in the morning they will have a meal.~      About 2 hours later they will have a spinal tap. For this, a numbing medicine is injected~     into the back. A needle is inserted between the bones in the back to remove a small amount of~     fluid. The spinal tap may be use x-rays to see inside the body.~      After the spinal tap, they will start taking NAC by mouth.~      They will take NAC twice a day for 2 more days.~      On the next day, they will not eat until a meal in the late morning. They will take a final~     NAC dose.~      About 2 hours later they will have a second spinal tap.~   "
35286|NCT03104712|"~     Pasta and rice are two of the most commonly consumed grains worldwide, where the former has a~     low GI (e.g. spaghetti) and the latter, usually (as it depends on the type) has a higher GI~     (e.g. white rice). The most typical ways in which pasta and rice are consumed are with the~     addition of oil or tomato sauce, and are recommended to be consumed in this way in the~     Mediterranean diet. The Mediterranean diet has been demonstrated to reduce the risk of~     cardiovascular disease, improve glycemic control and is encouraged in many clinical~     guidelines globally for both cardiovascular risk reduction. Some studies have explored the~     differences in glycemic response of different carbohydrate foods consumed with the addition~     of fat demonstrating that the glycemic response is indeed reduced.However, the GI may remain~     of importance even when other means to reduce glycemic response are introduced.~      The investigators therefore designed a randomized controlled crossover study to explore~     whether the addition of fat in the form of commonly consumed sauces which are recommended as~     part of a Mediterranean diet, affects the difference in glycemic response between a commonly~     consumed low GI and a higher GI carbohydrate food.~   "
35287|NCT03104699|"~     This is a Phase 1, open-label, 3 + 3 dose-escalation trial in subjects with metastatic or~     locally advanced solid tumors, with a consecutive Phase 2 expansion to evaluate efficacy in~     subjects with recurrent, unresectable, or metastatic (advanced) cervical cancer that has~     progressed after a platinum doublet.~   "
35288|NCT03104686|"~     Carbohydrate-based products can influence the post-prandial glycemic response differently~     based on their ability to be digested, absorbed and to affect rises in plasma glucose. Pasta~     is one of the major carbohydrate-rich foods consumed in Italy. Studies from the literature~     describe a lower glycemic response after the consumption of pasta compared with other~     wheat-based products, such as bread. Among the factors affecting post-prandial glycemia after~     consumption of carbohydrate-based products, the technological process represents a central~     one. In fact, the different technological processes alter the food matrix which can affect~     the post-prandial metabolism of glucose and insulin differently. Thus, the present study aims~     at investigating the effect induced by the principal steps of the process of pasta production~     on the reduction of post-prandial glycemic and insulinemic responses.~   "
35289|NCT03104673|"~     Preterm birth (PTB) occurs before 37 weeks of gestation and is a major cause of neonatal~     mortality and morbidity. PTB results from heterogeneous influences. One of them is the~     inherited predisposition of spontaneous PTB, and another is the change in the placental~     microbial composition as this can cause infections, which lead to inflammation, a common~     cause of preterm birth. Interestingly, maternal periodontal disease is an independent risk~     factor for PTB, low birth weight and fetal growth restriction. Immune responses to infectious~     events or inflammation as well as genetic predisposition to inherited conditions have~     successfully been studied by using assessing genetic expression profiling. The molecular~     signature is sets of genes, proteins, genetic variants or other variables that can be used as~     markers for a particular phenotype.~      Child morbidity from malnutrition resulting in poor growth and stunting remains a major~     public health issue that affects the local population just like PTB. Molecular signatures~     including the intestinal microbiome development of preterm infants will be evaluated and~     compared to the term (≥37 weeks' gestation) counterparts. Moreover, a comprehensive~     examination of possible factors associated with poor growth and poor motor- and~     neurodevelopment will be assessed.~      In this extension study: The primary goal for the child is to evaluate the perturbation in~     the development of the genomic profile including intestinal microbial habitat from children~     in a rural and limited-resource setting from birth to two years of life.~   "
35290|NCT03104660|"~     To evaluate the long-term results after transcatheter mitral valve repair~   "
35291|NCT03104647|"~     The current study is designed to evaluate neck movements performed according to the~     VRP-Clinic software, and to verify that they promote physical activities that correspond with~     physical rehabilitation.~   "
35292|NCT03104634|"~     This short-term study aims to prove the potential cardio-protective physiological effect of~     inhaled aclidinium bromide/formoterol fumarate on inspiratory pleural pressures.~      Smoking is associated with gas-trapping (hyperinflation), even in the absence of chronic~     obstructive pulmonary disease. Breathing in the presence of gas-trapping requires large~     negative inspiratory pleural pressures, which are transmitted to the surface of the heart and~     increase cardiac wall stress.~      Inhaled aclidinium bromide and formoterol fumarate has been shown to reduce gas-trapping, but~     the impact on inspiratory pleural pressures and biomarkers of cardiac stress in smokers is~     unknown.~   "
35293|NCT03104621|"~     The aim of this work is to evaluate efficacy and tolerability of preservative containing~     0.0015% tafluprost and preservative-free 0.0015% tafluprost. Both preservative containing and~     preservative-free 0.0015% tafluprost will reduce intraocular pressure significantly. In~     addition, preservative-free 0.0015% tafluprost might improve tolerability of glaucoma~     patients.~   "
35294|NCT03104608|"~     Age-related macular degeneration (AMD) is a condition affecting 20 to 25 million people~     worldwide. Symptoms of AMD includes difficulty in reading, recognizing faces and completing~     house work which may result in increased disability which in turn increase symptoms of~     depression and anxiety. Depression and anxiety could also be worsened by social isolation~     caused by AMD. Further, AMD causes high levels of emotional distress and reduced quality of~     life (QoL). Automatic Self Transcending Meditation (ASTM) - a standardized category of~     meditation - may help reduce stress, depression, anxiety, and may enhance QoL. Automatic Self~     Transcending Meditation (ASTM) is a class of meditation that helps quiet the mind and induces~     physiological and mental relaxation whilst the eyes are shut. It utilizes a specific sound~     value (mantra) to draw attention inward and permit the mind to experience a restful but alert~     state of consciousness. In the proposed research, the effects of ASTM on health related~     quality of Life (HRQoL), depression and anxiety in low-vision AMD patients will be studied. A~     single-center, single-blind longitudinal randomized controlled trial (RCT) will be conducted~     in London, ON. Patients with AMD (n = 140, 70 in each arm) will be randomized to ASTM plus~     treatment as usual (TAU) or TAU alone (control) arm. Data on routinely measured ophthalmic~     clinical variables, HRQoL, depression, and anxiety will be collected from both the arms.~     Statistical analysis will be conducted using STATA 15.0 to evaluate the effects of ASTM plus~     TAU compared to TAU alone on HRQoL, depression, and anxiety. Further, for each group - ASTM~     plus TAU and TAU alone - the investigators develop an association between HRQoL, depression,~     and anxiety with routinely measured clinical variables using mathematical models.~   "
35295|NCT03104595|"~     Part 1 of the study will determine the maximum tolerated dose (MTD) of EC-18 in subjects with~     relapsing or advanced breast cancer whose risk level for febrile neutropenia is low and who~     are receiving second line or higher chemotherapy that incorporates~     doxorubicin/cyclophosphamide.~      Part 2 will evaluate the MTD in the same subject population.~   "
35296|NCT03104582|"~     To investigate the biliary drainage-related cholangitis and other complications of~     percutaneous transhepatic biliary drainage (PTBD) in the management of Klatskin tumor (KT)~     compared with endoscopic biliary drainage (EBD).~   "
35297|NCT03104569|"~     The purpose of this study is to determine the effect of normal temperature and 37℃ non-ionic~     contrast agent acting on ERCP-related cholangeitis after endoscopic retrograde~     cholangiopancreatography (ERCP) in the treatment of hilar cholangiocarcinoma.~   "
35298|NCT03104556|"~     The MitraClip-procedure offers an interventional treatment for high risk patients with severe~     symptomatic mitral regurgitation. The number of new cerebral ischemic lesions without~     clinical manifestations is high. The aim of this study is to determine the frequency of~     cerebral embolisms and cerebral lesions during the MitraClip-procedure using transcranial~     doppler ultrasound and magnetic resonance imaging.~   "
35299|NCT03104543|"~     Survivors of childhood cancer are known to be at higher risk of developing premature, serious~     cardiovascular disease compared with the general population. Hypertension, dyslipidemia, and~     diabetes increase this risk beyond that attributable to one's original cancer therapy~     exposures. Research has shown that childhood cancer survivors also have a high burden of~     underdiagnosis and undertreatment of these potentially modifiable conditions. The goal of~     this study is to:~        1. To determine the prevalence of underdiagnosis and undertreatment of common~          cardiometabolic conditions (i.e., hypertension, dyslipidemia, diabetes) in survivors of~          childhood cancer at high-risk of future serious cardiovascular disease.~        2. Among survivors who are found to be underdiagnosed or undertreated, to determine (via~          randomized clinical trial) the efficacy of an educational intervention to improve~          control of these cardiometabolic conditions.~        3. Determine barriers on among survivors enrolled on the randomized trial and their primary~          healthcare providers that contribute to undertreatment of the study's targeted~          cardiometabolic conditions.~   "
35300|NCT03104530|"~     The brown meat from crab may contain high levels of the heavy metal cadmium. Cadmium is found~     in the environment and long-term exposure can cause accumulation in the body. High cadmium~     levels can be toxic to the kidney and have been statistically associated with an increased~     risk of cancer in the lungs, endometrium, bladder, and breast. This study aims to investigate~     if regular consumers of brown crabmeat have a higher body burden of cadmium than~     nonconsumers. This is important as no other studies that have addressed this subject. The~     results of this research may provide guidance on the consumption of brown meat from crab.~      The hypothesis of the proposal is that regular habitual consumption of brown crabmeat~     increases the body burden of cadmium.~      This study will recruit 25 healthy participants who consume brown crab meat and 25 healthy~     participants who do not consume brown crab meat. Volunteers will be eligible if they are ages~     40 years and older, non-smokers, and have not had significant occupational exposure to~     cadmium. Eligibility will be determined using a questionnaire that consenting volunteers will~     be asked to complete.~      Eligible participants will be asked to attend a study visit at the Rowett Institute or at a~     GP practice in Stromness (depending on participant location). Participants will be weighed~     and asked to provide a urine sample as well as a 40 ml (2-3 tbsp.) non-fasted blood sample.~      The blood and urine samples will be processed at the Rowett Institute or at the Balfour~     Hospital in Kirkwall (depending on where the study visit took place). Analysis will be~     completed at the Rowett Institute where whole blood will be analysed for cadmium, selenium,~     and zinc and the serum for creatinine and ferritin. Urine samples will be measured for~     cadmium, B2-microglobulin and creatinine.~      Recruitment is expected to take place over 4 months. Study participants will have the option~     of receiving feedback on their cadmium, zinc, selenium and ferritin levels.~   "
35301|NCT03104517|"~     This study evaluates the efficacy and safety of Autologous Muscle Derived Cells for Urinary~     Sphincter Repair (AMDC-USR) compared to a placebo in the treatment of stress urinary~     incontinence (SUI) in adult female patients. Half of the participants will receive AMDC-USR~     (injections with cells) and the other half will receive placebo.~   "
35322|NCT03104244|"~     The purpose of this study is to determine the neurologic and cognitive effects of playing~     tackle football in grade school and high school.~      During contact practices and games, players wear a football helmet containing an impact~     sensor. Before and after each season, players complete neurological testing to measure~     several different aspects of brain function.~      Two groups of football players will be in the study:~      5th and 6th grade tackle football players from the Brighton Bulldogs Football and Cheer~     league (about 70 players).~      Varsity football players from Brighton High School (about 70 players per year).~      The study begins in July 2016 and will continue for 4 years (through the winter of 2020).~   "
35302|NCT03104504|"~     SOS will identify evidence based best practices consistent with Zero Suicide's six specific~     recommended clinical actions (A.2.) and use them to develop standardized clinical protocols~     for each care setting, clinical unit, population serviced, and clinical discipline. Using~     Lean CQI, the investigators will tailor, implement, and improve adherence to these protocols.~     To support feasibility, SOS will use a phased roll out and a hub-and-spoke design. The~     intervention targets will be suicide-related clinician behaviors. The investigators will~     aspire to adopt best practices and measure all six recommended performance elements; however,~     for feasibility, the research evaluation will focus on suicide risk screening, safety~     planning, means restriction counseling, and post-acute care follow-up calls. The primary~     patient outcomes will be suicide risk identification, suicide, suicide attempts, and~     suicide-related emergencies requiring acute care. The investigators will examine potential~     mechanisms of action and moderators, and conduct a cost effectiveness analysis of SOS versus~     usual care. The investigators will employ a stepped wedge design and follow individuals for 6~     to 54 months. Outcomes, clinician behaviors, and other variables will be gathered through:~     (1) EHR data extraction, (2) claims data from UMMHC and the MA All Payer Claims Database, (3)~     random medical chart abstractions, (4) MA state vital statistics and National Death Index~     (NDI), (5) clinician surveys, (6) Lean evaluations and process observations, and (7) patient~     fidelity interviews. Data will be analyzed using generalized linear mixed models.~   "
35303|NCT03104491|"~     This study has two phases, Phase I and Phase II. The main goal of the Phase I portion of this~     research study is to see what doses post-transplant inotuzumab ozogamicin can safely be given~     to subjects without having too many side effects.~      The Phase II portion of this study is to see what side effects are seen with medication after~     transplant.~      Inotuzumab ozogamicin is a combination of an antibody and chemotherapy. This means that it~     targets the acute lymphocytic leukemia (ALL) cell and can deliver the chemotherapy to the ALL~     cell. Research shows that in some patients, it has caused their disease to go back into~     remission.~      Inotuzumab ozogamicin is considered experimental in this study.~   "
35304|NCT03104478|"~     The trial will enroll 194 previously untreated DLBCL patients over 20 months, with the~     objective to send to the local investigator an extensive molecular tumor characterization by~     D38 in at least 80% of enrolled patients.~      The feasibility and efficiency will be demonstrated by deploying and operating a nation-wide~     network of dedicated multidisciplinary platforms.~   "
35305|NCT03104465|"~     The overall aim of this study is to test the acceptability and feasibility of an interactive,~     web-based mindfulness training with active duty soldiers being treated for chronic pain.~   "
35306|NCT03104452|"~     The purpose of this study is to learn how women's smoking changes during their pregnancy and~     as a new mom, and to assess the help they receive from their health care providers.~   "
35307|NCT03104439|"~     This research study is studying a combination of drugs with radiation therapy as a possible~     treatment for Microsatellite Stable Colorectal Cancer, Pancreatic Cancer, or MSI High~     Colorectal Cancer.~      The interventions involved in this study are:~        -  Nivolumab~        -  Ipilimumab~        -  Radiation Therapy~   "
35308|NCT03104426|"~     Up to 80% of infants with hemolytic disease due to maternal alloimmunization, treated with~     IUT, require at least one top-up transfusion for late anemia during the first 3 months of~     life. Erythropoietin deficiency is also considered as a possible contributing factor to late~     anemia and therefore we will assess the role of EPO (darbepoetin alfa) in the treatment of~     these infants.~   "
35309|NCT03104413|"~     The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus~     placebo during induction therapy in subjects with moderately to severely active CD.~   "
35310|NCT03104400|"~     This is a Phase 3 multicenter study that includes two periods. Period 1 is designed to~     compare the safety, tolerability, and efficacy of ABT-494 Dose A once daily (QD) and Dose B~     QD versus placebo and versus adalimumab every other week (eow) in participants with~     moderately to severely active Psoriatic Arthritis (PsA) and have an inadequate response to~     non-biologic DMARDs (DMARD-IR). Period 1 is also designed to compare the efficacy of ABT-494~     Dose A QD and Dose B QD versus placebo for the prevention of structural progression. Period 2~     evaluates the safety, tolerability and efficacy of ABT-494 Dose A QD and Dose B QD in~     participants with PsA who have completed Period 1.~   "
35311|NCT03104387|"~     Ambient air pollution is a complex mixture of gaseous pollutants and particulate matter (PM).~     PM has a recognized important role in human health. There is a strong scientific consensus on~     the independent association of PM and adverse cardiovascular and respiratory effects, as well~     as cancer. It is reasonable to expect that the smaller particles (ultrafine particles, UFP)~     may have an enhanced toxicity relative to other PM size fractions, due to physical properties~     and potential to translocation beyond the lung.~      A recent Danish report concluded that train conductors on a working day, and in two specific~     diesel engine trains, are exposed to higher concentrations of diesel exhaust than by constant~     stay in a busy street. Indeed, the average exposure for train conductors on such engines was~     around 100,000-150,000 UFP per cm3 as compared with around 40,000 per cm3 on a busy street in~     Copenhagen [1]. The aim of this study is to investigate if this occupational exposure is~     associated with vascular and respiratory impairment and DNA damage.~   "
35312|NCT03104374|"~     This is a Phase 3 multicenter study that includes two periods. Period 1 is designed to~     compare the safety, tolerability, and efficacy of ABT-494 Dose A once daily (QD) and Dose B~     QD versus placebo in participants with moderately to severely active Psoriatic Arthritis~     (PsA) who have an inadequate response to Biological Disease Modifying Anti-Rheumatic Drug~     (bDMARDs). Period 2 evaluates the safety, tolerability and efficacy of ABT-494 Dose A QD and~     Dose B QD in subjects with PsA who have completed Period 1.~   "
35375|NCT03103555|"~     This is pilot study aimed to investigate the application of proteosome inhibitor, Bortezomib~     in treatment of patients with neutralizing autoantibody to IFN-γ. The investigators~     hypothesis is that bortezomib will reduce the antibody level and restore interferon-gamma~     function, resulting in clinical improvement and should be well-tolerated and safe for use in~     patients with autoantibody to IFN-γ.~   "
35376|NCT03103542|"~     The primary purpose of this study is to describe the outcome of Immune Tolerance Induction~     (ITI) treatment performed with rFVIIIFc within a timeframe of 60 weeks in patients with~     haemophilia A who have failed previous attempts at tolerization.~   "
35313|NCT03104361|"~     Interstitial cystitis/painful bladder syndrome (IC/PBS) is a debilitating chronic disease of~     unknown etiology characterized by urgency frequency and suprapubic pain at full bladder.~     Current treatments are usually unsuccessful in completely eradicating bladder pain and~     increasing bladder capacity. Autologous platelet-rich plasma (PRP) is growing in popularity~     as a therapy to augment wound healing, speed the recovery from muscle and joint injuries, and~     enhance recovery after surgical repair. PRP is extremely rich in growth factors and~     cytokines, which regulate tissue reconstruction and has been studied extensively among trauma~     patients and trauma experimental models. Tissue regeneration can be improved by local~     application of autologous bone marrow derived progenitor cells and PRP. This clinical trial~     attempts to use autologous PRP in treatment of interstitial cystitis refractory to currently~     available medical treatment or intravesical therapy. The results of this study might provide~     clinical evidence for a novel therapeutic regimen in the treatment of IC/PBS.~   "
35314|NCT03104348|"~     A recent French study conducted in the general population in the north, using more than~     12,000 people randomly drawn from the electoral lists, shows a prevalence of nearly 15% of an~     obstructive spirometric function disorder; The diagnosis was ignored in 70% of cases. If we~     consider the Finistère situation, the mortality data are unfavorable, with an excess of COPD~     mortality compared to the French average.~      Compared to other frequent chronic conditions, such as high blood pressure or diabetes, the~     management of COPD may appear complex for at least two reasons:~        -  Screening is difficult because of the banality of symptoms and the need for spirometry~          to confirm the diagnosis;~        -  Comorbidities are masking the respiratory pathology; It is on this first point~          concerning the difficulty of screening that this project focuses.~      It is true that the development of screening strategies for COPD has been the subject of~     numerous studies, the results of which are controversial. The target population of smokers~     over the age of 40, who are readily selected, is difficult to achieve as a whole because the~     use of care is far from homogeneous. Many people do not have a general practitioner.~      Recent reviews of COPD screening do not recommend systematic screening for COPD in adults.~     However, they emphasize the feasibility of screening by questionnaire and / or portable~     spirometry. A selection of patients suspected of exacerbations (patients with at least one~     episode labeled bronchitis) could increase the cost-effectiveness of screening by focusing~     on the most severe cases.~      In France, the High Authority for Health (HAS), inspired by the work of the WHO (GOLD~     programs), offers a simple five-question questionnaire available online for all healthcare~     professionals in order to facilitate an indication of screening spirometry, where the~     proposed approach combines symptom identification with active smoking. General practitioners~     are in this first line of approach for the diagnosis: in fact, the HAS, in its guide of the~     pathway of care of the patient COPD, recommends that the general practitioner can carry out~     the spirometric screening. The corresponding pulmonologist intervenes in this course by~     completing the explorations and optimizing the management, especially in patients with~     frequent exacerbations. This ideal scheme is hampered by the present practical organization,~     a minority of general practitioners (10%) practicing in multidisciplinary health centers,~     places where the organization of a functional respiratory measurement can be easier.~      The current recommendations for smoking cessation allow the coding of this management. It is~     global, applicable in primary care. It proposes as a starting point the minimal advice, then~     associates medicines of assistance with the stop, cognitive-behavioral therapies and a~     prolonged follow-up of the patients after weaning. However, although these comprehensive~     management techniques are effective for smoking cessation, it is shown that they are~     underutilized in routine practice by health professionals with low patient participation~     rates. This is noticed, whereas the application of the minimum board alone would allow about~     200 000 people to have access to weaning every year.~      In a complementary way, the performance of a functional respiratory test in the active~     smoking patient has been proposed as a full-fledged tool for the weaning assistance process.~     Analysis of the literature, however, yields discordant results. Two recent studies have~     revived the debate: they highlight the potential of spirometry as a communication medium in~     the context of smoking cessation (using pulmonary age) by confronting patients with the~     discovery and understanding of their ventilatory disorder obstructive.~      Finally, if other health care providers are invited to participate actively in screening,~     including pharmacists, their place in this screening strategy has been less valued. In~     particular, pharmacists and dentists are required to provide care to patients with little or~     no use of the general practitioner: screening for COPD among these patients deserves~     consideration. Similarly, nurses occupy a special place, being called in particular to carry~     out regular care of patients, both in their office and at home. The administration of~     injectable antibiotics in a context of exacerbation of unlikely COPD is a frequent care~     opportunity, which may include this more comprehensive approach. Finally, physiotherapists,~     who are increasingly trained in the concept of respiratory rehabilitation, are taking charge~     of other potentially COPD smokers for other pathologies.~      Based on the willingness of Finnish actors to work on a COPD pathway with the help of the~     regional health agency, the investigators propose to question the respective place of health~     care professionals involved in primary care among potentially COPD patients: Dentists,~     nurses, general practitioners, physiotherapists and pharmacists~   "
35315|NCT03104335|"~     Patients with advanced soft tissue sarcoma(rhabdomyosarcoma and liposarcoma excluded), who~     experience progression after standard chemotherapy, have limited treatment options which~     promise a survival benefit.This trial tends to explore apatinib, which is a domestic highly~     selective inhibitor of vascular endothelial growth factor receptor-2, as a treatment option~     for heavily pretreated soft tissue sarcoma patients.~   "
35316|NCT03104322|"~     Pilot-scale, open-label, fixed-order, two-period crossover study in idiopathic pulmonary~     fibrosis (IPF) over 16 weeks. Patients will use an electronic health journal (patientMpower~     platform) to record treatment compliance, forced vital capacity (FVC; daily), impact of IPF~     on daily life (weekly) and other symptoms. Objectives are to characterise acceptability of~     patientMpower platform from patient & healthcare professional perspective, impact of active~     engagement and self-monitoring using patientMpower platform on Patient Reported Outcome~     Measures (PROMs) in IPF, impact of patientMpower platform on medication compliance and~     correlation between patient-reported PROMs & FVC and clinical outcomes.~   "
35317|NCT03104309|"~     Adenomyosis is defined when the endometrial tissue (gland and stroma) is present within the~     myometrium . The depth of endometrial penetration which uses in diagnosis of adenomyosis not~     yet agreed; opinions range from one high power field to 25% of the myometrial thickness. It~     is a common condition in women aged 40-50 years and is considered an important cause of~     dysmenorrhea and menorrhagia in around 65 % of cases.~      Until past few years; hysterectomy was the suggested definitive treatment, however; this may~     not be acceptable to women not willing to loss their fertility. Many treatment lines were~     studied and proved their beneficial effect on adenomyosis such as GnRH agonists, danazol,~     combined oral contraceptive pills, dienogest and finally endometrial ablation. However, these~     line of treatment are not commonly used because high incidence of side effects and relatively~     high cost of some of them.~      The levonorgestrel-releasing intrauterine system (LNG-IUS) was emerged as an effective line~     for treatment of adenomyosis associated pain and bleeding. It can successfully, within 6 to~     12 months, down-regulate the estrogen receptors in adenomyotic tissues which lead to~     decidualization and atrophy of the adenomyosis .~      In fact, some adenomyotic women respond well to LNG-IUDs and show high acceptability and~     satisfaction, on the other hand; a group of women may not respond to LNG-IUDs and opt to~     remove it and start a new medical or surgical option for treatment.~      However, factors related to LNG-IUS effectiveness in patients with adenomyosis were not well~     available. Only one report states that a large uterine volume could be a factor associated~     with LNG-IUS treatment discontinuation in adenomyotic patient.~      For this reason; the prediction of the responsiveness to LNG-IUS is interesting issue which~     should be addressed. The present study examines the hypothesis that patient's data reported~     at baseline visit before using LNG-IUSfor controlling pain/bleeding with adenomyosis can help~     the prediction of the responsiveness for this important line of treatment at 6 months follow~     up visit. Up to our knowledge; no clinical trial had been registered or conducted to predict~     the responsiveness for LNG-IUS in controlling the pain/ bleeding with adenomyosis.~   "
35318|NCT03104296|"~     The recent improvements in neonatal intensive care have led to a substantial increase in the~     survival rate of preterm infants; nevertheless, this population is still at high risk for~     long-term neurodevelopmental disabilities. Significant anatomical changes in brain structures~     and abnormal patterns of neuronal myelination and brain connectivity have been associated~     with preterm birth, with possible long-term effects on cognitive, motor and social skills.~      The validation of clinical tools able to predict neurodevelopmental outcomes in the preterm~     population might help at identifying infants at greatest risk of impairment, who would~     benefit most from early supportive interventions exploiting brain neuroplasticity.~      Near infrared reflected spectroscopy (NIRS) provides a bedside, non-invasive, continuous~     monitoring of cerebral oxygen saturation (CrSO2), which has been proposed as a predictive~     marker for later neurodevelopment in neonates undergone cardiac surgery; to date, however,~     evidence on the correlation between CrSO2 and later neurodevelopment in preterm infants is~     almost lacking.~      This study aims to evaluate whether CrSO2 monitoring, performed before NICU discharge in~     clinically stable very low birth weight (VLBW) preterm infants, can predict psychomotor~     outcomes during the first 24 months of corrected age (ca).~   "
35319|NCT03104283|"~     The purpose of our study is to assess the efficacy and safety of apatinib in elderly advanced~     gastric cancer patients, and to find the relationship between the expression of VEGFR-2 and~     efficacy of apatinib treatment.~   "
35320|NCT03104270|"~     Despite the recent introduction of novel anti-multiple myeloma (MM) agents, high risk MM~     remains with poor prognosis and a therapeutic challenge. Elotuzumab (ELO) is a humanized~     monoclonal antibody that recognizes CS1/CD139, a molecule highly expressed in MM cells. The~     ELO (10 mg/kg), lenalidomide (LEN) and dexamethasone (DEX) combination achieves high overall~     response rates (ORR) and long progression-free survival (PFS) for patients with~     relapsed/refractory disease (RR) MM and those with impaired renal function. However, its~     efficacy for MM patients with high risk characteristics is still unknown. Pomalidomide (POM)~     is a recently approved immunomodulatory agent (IMiD) that produces response rates for~     high-risk RRMM patients when used in combination with DEX and other agents, including the~     proteasome inhibitor (PI) bortezomib (BTZ). POM has also demonstrated activity for LEN~     refractory patients. Carfilzomib (CFZ) is a potent second generation PI that has shown to be~     efficacious for IMiD and BTZ refractory patients as well as high risk patients carrying~     cytogenetic abnormalities. In this study, we propose to evaluate efficacy and safety of ELO~     in combination with POM, DEX and CFZ for high-risk RRMM patients.~   "
35321|NCT03104257|"~     The purpose of this research study is to determine the temporal course of recovery of CB1R~     availability and neural oscillations, in cannabis-dependent individuals at baseline,~     following 48 hour confirmed inpatient abstinence and after four weeks confirmed abstinence.~     This research will also examine associations between CB1R availability, neural oscillations~     and cognitive function.~   "
37300|NCT03078400|"~     Up to 18 women with ovarian cancer will administer up to two injections of SPL-108 daily in~     combination with weekly doses of Paclitaxel. They will be monitored for safety and efficacy~     for up to 6 months, until disease progression or unacceptable toxicity.~   "
35323|NCT03104231|"~     Atrial fibrillation (AF), which is the most common cardiac arrhythmia in adults, is~     associated with a high risk of stroke and other thromboembolic complications. The usage of~     oral anticoagulation (OAC) may prevent the incidence of the thromboembolic events in the~     majority of patients. The current guidelines for the management of AF patients highlight the~     important role of patients' education, since the clinical benefit from OAC treatment may be~     achieved by the effective cooperation between patients and physicians. It has been suggested,~     that compliance may be increased by the novel e-solutions introduced into the daily clinical~     practice. Due to the improvement in advanced technologies, the virtual reality (VR)~     three-dimensional (3D) movie stands for a future alternative in e-medicine. The aim of the~     OCULUS study was to examine whether the 3D movie-based knowledge transfer is effective in~     teaching patients about the consequences of AF and pharmacological possibilities in reducing~     the risk of stroke.~   "
35324|NCT03104218|"~     Transcranial direct current stimulation (tDCS), an electrostimulation technique known to~     modulate the motor cortex excitability, has been shown to enhance the effects of~     rehabilitation in populations with neurological injuries. tDCS could similarly be effective~     in individuals with rotator cuff (RC) tendinopathy, as this pathology is also associated with~     pain and motor control deficits. For the treatment of RC tendinopathy, sensorimotor training~     is effective to reduce pain, increase function and enhance motor control of the shoulder. The~     addition of tDCS during sensorimotor training could enhance motor learning associated with~     sensorimotor training and thus improve treatment outcome. PURPOSE: To compare, in terms of~     symptoms, functional limitations and shoulder control, a group receiving a rehabilitation~     program centered on sensorimotor training combined with tDCS to a group receiving the same~     rehabilitation program combined with sham tDCS in individuals with RC tendinopathy. METHODS:~     Forty adults with RC tendinopathy will take part in the 4 evaluation sessions (0, 3, 6, 12~     weeks) and a 6-week rehabilitation program. Outcome measures will be symptoms and functional~     limitations (Disability of the Arm, Shoulder and Hand and the Western Ontario Rotator Cuff~     index), as well as acromiohumeral distance ([AHD] ultrasonographic measurement at 0° and 60°~     of elevation arm). The rehabilitation program will include sensorimotor training,~     strengthening and education. tDCS will be apply during sensorimotor training on the motor~     cortex contralateral to the side of pain. A 2-way ANOVA will be used to analyse the effects~     of tDCS on the outcomes.~   "
35325|NCT03104205|"~     The goal of this study is to conduct a program of pilot research aimed at developing and~     evaluating a technology-assisted wellness intervention for older adults with obesity.~   "
35326|NCT03104192|"~     The goal of this study is to conduct a program of pilot research aimed at developing and~     evaluating a technology-assisted wellness intervention for older adults with obesity.~   "
35327|NCT03104179|"~     In a lot of cases during cardiac surgery cardiopulmonary bypass initiates SIRS due to release~     of cytokines during immunological response.~      They are induced by different types of inductors ( intrinsic and extrinsic). High levels of~     inflammation markers like TNF-a, IL 6 and IL 10 as well as TGF-ß are detectable after 2 hours~     of surgery.~      Beside the inflammation acute phase parameters like fibrinogen, ferritin are increased. These~     changes lead to rheology impairments.~      These strong reactions lead to dysfunction of different organs possibly culminating in a~     multi organ failure.~      There is a correlation between amounts of cytokines and mortality. Often AKI occurs after CPB~     with a rate of about 30%. Dysfunctions of organ function are often connected with increased~     mortality, prolonged mechanical ventilation , septic complications, increased catecholamine~     dosages and prolonged length of ICU stay.~      Use of cytokine adsorption within the extracorporeal circuit during CBP can affect the~     circulating cytokine levels during and after CPB and lead to a diminished inflammatory~     response, acute phase reaction as well as reduction of organ failure.~   "
35328|NCT03104166|"~     50 patients will be randomized and treated with MCO or highflux dialysis for six months (24~     weeks) after a run-in phase of 4 weeks Highflux treatment.~      Serum samples will be drawn at baseline, after 4, 8 and 24 weeks.~      Later, calcifiying vascular smooth muscle cells will be incubated with these serum samples~     and calcification will be assessed with Alkaline phosphatase and Alizarin staining.~      Primary endpoint:~      In vitro Calcification of coronary vascular smooth muscle cells (Alkaline Phosphatase/ WST8)~     after six months~      Calcifiying vascular smooth muscle cells will be incubated with serum samples obtained after~     six months of MCO/HF dialysis and calcification will be assessed with Alkaline phosphatase~     and WST8.~      Secondary Endpoints:~      Aortic Pulse wave velocity after 6 months Calcification propensity after 6 months Physical~     activity level after 6 months~      Cell culture: Incubation of VSMC with serum samples obtained after 6 months~        -  Alizarin staining/WST-8~        -  Measurement of calcification inhibitors Osteopontin and Matrix Gla Protein in~          Supernatants~        -  Apoptosis~      The treatment regimen of the patients will not be altered, hence blood flow, dialysate flow~     as well as dialysis time will remain constant.~   "
35329|NCT03104153|"~     To compare early drain removal versus output-based drain removal, assessing the following~     end-points:~      Clinical : risk of seroma and infection, woundhealing, duration of wound care and drain~     output versus volume of seroma.~      Quality of life : drain-induced pain, discomfort due to seroma or drain, sleep disturbance~     and implications on daily activities.~      Cost-effectiveness~   "
35330|NCT03104140|"~     The aim of this work is to compare two protocols (ketamine-fentanyl-midazolam versus~     thiopental-fentanyl-midazolam) for induction of anesthesia in patients with septic shock~     aiming to find the most safe protocol with regards to hemodynamic status of patients.~   "
35331|NCT03104127|"~     This study will investigate if a lower limb robotic device can be used in a community setting~     to increase the amount of physical activity that individuals undertake following stroke and~     consequently improve biomechanical, physiological and health outcomes, in patients with~     stroke.~   "
35377|NCT03103529|"~     It has been suggested that activity immediately following concussion is detrimental to~     recovery and may lead to long term impairments. The animal model has shown that exercise too~     soon can lead to neurometabolic energy imbalances within the brain. However, there is also~     evidence to suggest that prolonged inactivity has negative consequences that may contribute~     to prolongation of symptoms. Determining the ideal timeframe in which to initiate an active~     rehabilitation protocol for patients who are slow to recovery is an important factor in~     concussion management.~   "
35332|NCT03104114|"~     Boston Medical Center provides care to cancer patients on oral cancer medications through the~     use of Boston Medical Center Specialty Pharmacy (BMC SP). The use of oral medications in~     cancer treatments is relatively new and unfortunately, very little is known about adherence~     in cancer patients. This study will evaluate the influence of a pharmacist-driven medication~     management program on adherence and persistence rates. Boston Medical Center's Specialty~     Pharmacy Adherence Program (B-SPAP), will utilize a high-touch counseling model involving~     clinical pharmacist that will focus on educating patients about their oral cancer treatments.~     The program will require face-to-face counseling with a pharmacist, through the use of a~     proven patient teaching tool, prior to initiating treatment with oral oncolytic treatments~     and, periodically thereafter, based on protocol. This study will help improve our~     understanding of the role of the pharmacist in cancer patients. In addition, the study will~     help identify independent factors that may contribute or impact adherence. The outcomes of~     this program will be compared to a historical control group of patients that have already~     received treatment for their cancer through the BMC Specialty Pharmacy.~   "
35333|NCT03104101|"~     This study was done to verify whether the combination of transcutaneous posterior tibial~     nerve stimulation (TPTNS) with low dose trospium chloride in the treatment of females with~     overactive bladder (OAB) would be more effective than TPTNS alone after failure of behavioral~     therapy.~   "
35334|NCT03104088|"~     Comparing the cognitive levels of patients with SPG4 mutations to healthy controls.~   "
35335|NCT03104075|"~     This is a prospective, single-site, randomized, then open-label study designed to develop a~     detailed transcriptional and epigenetic profile of the immune response to pneumococcal~     vaccination with conjugated and non-conjugated polysaccharide vaccines in the senescent~     immune system of older adults.~      In this study, 40 healthy adults ages 65 and older that have never received pneumococcal~     vaccination, will be randomized in a 1:1 ratio to receive Prevnar-13 (Pfizer), a conjugated~     13-valent vaccine or Pneumovax 23 (Merck), a non-conjugated 23-valent vaccine. Following~     randomized assignment of vaccine, the study will be open-label.~      Six (6) study visits will occur over about 70 days, with an optional 7th visit for~     participants to receive a second vaccination with the other pneumococcal vaccine one to two~     years after randomization. Participants will provide blood samples for transcriptional,~     epigenetic and biological analyses pre- and post-vaccination.~   "
35336|NCT03104062|"~     Of the patients diagnosed with ST-segment elevation myocardial infarction (STEMI) who~     underwent reperfusion therapy and have thrombolysis in myocardial infarction (TIMI) 3 flow,~     about 40% have flow alterations in the coronary microcirculation, which leads to worse~     remodeling of the left ventricle with a consequent increase in the mortality of this~     population. Clopidogrel is the only known antiplatelet medication that brings benefits to the~     coronary microcirculation. Ticagrelor is significantly superior to clopidogrel in terms of~     decreasing mortality.~      The main objective of this study is to compare the effect of ticagrelor versus clopidogrel on~     the coronary microcirculation by the Myocardial Perfusion Score Index (MPSI) obtained using~     Microbubble Contrasted Echocardiography (MCE) in patients who have STEMI and treated with~     thrombolysis.~   "
35337|NCT03104049|"~     Parkinson's disease (PD) is a degenerative disorder characterized by a symptom triad~     consisting on: tremor, rigidity and bradykinesia . To these symptoms it is often added~     postural alteration that can stand in two different attitudes, such as the camptocormia and~     the syndrome of Pisa . Progressing in its evolution, PD becomes increasingly disabling,~     making it difficult or even impossible daily activities such as washing or dressing.The~     abnormal posture, with alteration of the limbs, the neck and trunk, is a recurring feature in~     PD, with a frequency of about 30%. Between 2% and 12.3% are more severe abnormalities such as~     camptocormia, the syndrome of Pisa and the anterocollis. Several studies disease plug in~     Neuromuscular Taping technique (NMT) among rehabilitative tools in degenerative neurological~     syndromes.~      To the best of our knowledge, no applications were found in PD. Therefore, the current study~     was designed to evaluate quantitatively the effects of the NMT intervention on the trunk~     kinematics during standing position. More specifically, this study aims to compare the trunk~     kinematic variables of patients with PD who were treated with effective NMT versus those of~     the subjects who received only the pharmacological treatment.~   "
35338|NCT03104036|"~     The etiopathogenesis of ulcerative colitis (UC) is not fully understood. One of the theories~     of UC pathogenesis represents a pathological response of mucosal immunity to intestinal~     microbiota. Potential therapeutic procedure how to affect this fact is the faecal microbiota~     transplantation (FMT). Review of the literature on FMT suggests great potential as the~     treatment for UC, but two prospective controlled study that has been published yet are~     inconsistent.~      The first objective of the project is to compare the administration of FMT enema with~     mesalazine enema for inducing remission in patients with active left-sided UC in the form of~     a prospective, randomized, controlled study. The second objective is to observe changes in~     the intestinal microbiota during and after FMT focusing on bacterial DNA sequencing to~     identify the bacterial species which are responsible for the effect of the FMT.~   "
35339|NCT03104023|"~     Patients undergoing laparoscopic sleeve gastrectomy will be randomized into 2 groups. In one~     group, a staple line inversion with a running suture of Polypropylene will be performed. In~     the second group, the gastric section will be performed with a stapler with preloaded~     buttress material~      Postoperative nausea and vomits during the first 24 hours will be investigated.~   "
35340|NCT03104010|"~     This study aims to explore the optimal dose of PEG-rhGH injection in the treatment of AGHD,~     preliminarily evaluate its safety and efficacy, to provide scientific and reliable evidence~     for the medication dosage in Phase 2 clinical study.~   "
35378|NCT03103516|"~     To compare the effects of early (within 24 hours) and delayed (exceed 24 hours) epidural~     decompression surgery on the recovery of spinal nerve function in patients with acute spinal~     cord injury (complete and incomplete) at postoperative 6 months.~   "
35379|NCT03103503|"~     The purpose of this registry is to confirm the long-term safety and reliability of~     BIOTRONIK's Plexa ICD lead.~   "
35380|NCT03103490|"~     The investigators will evaluate the detection of cardiac sarcoidosis or inflammation using~     18F-FSPG PET/MRI.~   "
37301|NCT03078387|"~     This study shows how careful ophthalmic examination of two patients showed signs of~     simultaneous bilateral retinal emboli. Starting from this point significant, life~     threatening, underlying reasons were found and treated.~   "
35341|NCT03103997|"~     Since its inception, endoscopic ultrasound with fine needle aspiration (EUS-FNA) has proven a~     valuable diagnostic and prognostic tool for evaluating a diverse number of pathologies. One~     such pathology is chronic liver disease (CLD), for which EUS-guided liver biopsy has become a~     well-accepted method for tissues acquisition. EUS-LB also been compared with percutaneous and~     transguluar routes showing at least comparable ability to obtain adequate tissue for CLD.~      Though enhancements to EUS-FNA, such as dry suction, stylet pull have not proven to~     demonstrate increased diagnostic accuracy for EUS-FNA, the use of wet suction technique~     (WEST) has demonstrated the ability to obtain more cellular tissue samples with less blood~     contamination. In an attempt to obtain further improvement in tissue adequacy, with less~     blood contamination for EUS-LB, the use of wet heparinized needles will be investigated as~     compared with conventional EUS-LB for patients with CLD. To do this subjects shall be~     selected to undergo EUS-LB. As it is the standard to perform 3 needle passes during EUS-LB,~     subjects will undergo one pass with the following designations: pass 1: conventional EUS-LB~     [no flush], pass 2: dry heparin heparin [5 milliliters (mL) of heparin flushed and then~     flushed with air], and pass 3: wet heparin [5 milliliters (mL) of heparin flushed and~     retained in the needle]. It is predicted that specimens collected with heparinized needle~     shall show improved adequacy compared with conventional EUS-LB. It is also predicted that the~     heparin wash will lead to less blood contamination compared with conventional methods.~     Subjects shall also be monitored for adverse events (AE).~   "
35342|NCT03103984|"~     The main goal of this project is to evaluate the effect of immunosuppression in the weight~     loss and in the metabolic status of patients after liver transplantation. It is also the~     purpose of this project to investigate why patients become overweight and obese after liver~     transplantation.~   "
35343|NCT03103971|"~     This phase I trial studies the side effects of autologous human anti-CD19 chimeric antigen~     receptor (CAR)-4-1BB-CD3zeta-EGFRt-expressing CD4+/CD8+ T-lymphocytes (huJCAR014) in treating~     patients with relapsed or refractory B-cell non-Hodgkin lymphoma or acute lymphoblastic~     leukemia. huJCAR014 CAR-T cells are made in the laboratory by genetically modifying a~     patient's T cells and may specifically kill cancer cells that have a molecule CD19 on their~     surfaces.~   "
35344|NCT03103958|"~     The probiotic for oral use, Probiatop®, consists of Lactobacillus acidophilus NCFM,~     Lactobacillus rhamnosus HN001, Lactobacillus paracasei LPC-37 and Bifidobacterium lactis~     HN019. Its activity will be compared with placebo (Maltodextrin). The metagenomics data will~     be correlated with the Quality of Life Questionnaire answers obtained from participants with~     intestinal transit problem. The Increase in the number of evacuations, as well as the~     improvement of complaints related to intestinal transit alteration will be evaluated during~     the study. The participants will use probiotic or placebo for a period of 28 days and the~     gastrointestinal function questionnaire and collect stool will be performed before the study~     and after period of treatment~   "
35345|NCT03103945|"~     This observational study evaluates peri-procedural results of the Niobe™ Remote Magnetic~     Navigation (RMN) ES system using the contact detection system (CDS) in patients undergoing~     standard of care radiofrequency ablation of cardiac arrhythmias.~      The objective of this observational study is to confirm system performance of the CDS and~     that it does not alter pacing, electrocardiograms, or mapping during RF ablation procedures.~   "
35346|NCT03103932|"~     This is a multi-centre, single blind, randomized study. Patients admitted to hospital with~     acute decompensated heart failure will be randomized to biomarker guided discharge algorithm~     vs usual care in a 2:1 ratio. NTproBNP and other biomarkers will be measured within 24 hours~     of admission. The NTproBNP results will be used to further stratify participants randomized~     to the biomarker guided group into lower and medium to higher risk pathways. Biomarkers will~     be repeated after 2-3 days and again prior to discharge. Specific care pathways will be~     followed for each of the lower risk and medium-higher risk groups. Biomarkers will be~     repeated 30 days post discharge. Participants will be followed with a phone call at 3 months~     and return for a follow up visit at 6 months post discharge for outcome evaluation.~   "
35347|NCT03103919|"~     Evaluate the benefits of Kinesia-360™ wearable technology in addition to standard clinical~     practice on improving Parkinson´s disease motor symptoms, Neupro dosing regimen and adherence~     to Neupro compared with only standard clinical practice.~   "
35348|NCT03103906|"~     Evaluation of the local tolerance and cosmetic efficacy of a topical skin care formulation in~     healthy female participants with mild to advanced photo-damaged facial skin who have~     undergone a 70% Glycolic Acid facial peel procedure.~   "
35349|NCT03103893|"~     This trial examines the impact of a topical formulation of rapamycin on dermal thickness and~     senescence.~   "
35350|NCT03103880|"~     The purpose of the study is to determine the feasibility and acceptability of at-home use of~     the Cohero mHealth (mobile health) technology, which consists of a Bluetooth Low Energy~     connected medication-use sensor (HerotrackerTM) that monitors at-home medication use, mobile~     application (BreatheSmart) that sends real-time reminders, and mobile spirometer~     (mSpirometer) that measures lung function, through a virtual observational study format in~     order to improve patient engagement with the platform for sustainable use and motivate~     subjects to self-manage their disease.~   "
35351|NCT03103867|"~     The study is an open label single centre randomised cross over study to evaluate the impact~     of a sensor augmented pump (SAP) with a predictive algorithm to suspend temporarily insulin~     administration (640G® with the Smart Guard feature) versus the use of the same pump for~     insulin administration with 'only' continuous glucose measurements (not interacting with the~     pump, Freestyle Libre ® ) on the time in glucose target , in hypo- and hyperglycemia.~     Exploratory endpoints are the effect on sleep and quality of life in children with type 1~     diabetes and their caregivers.~   "
35352|NCT03103854|"~     This is a 2x2 study examining the impacts of a novel exercise regimen and daily text message~     reminders in patients at high risk for cardiovascular disease. Patients participating in~     cardiac rehabilitation will be randomized to either moderate intensity continuous training~     (MICT) or a novel exercise regimen consisting of three periods of high intensity exercise,~     called BURST exercise. Additionally, half of the patients in each exercise group will be~     randomized to receive daily text message reminders to improve adherence to the prescribed~     exercise regimen.~   "
35353|NCT03103841|"~     Obstructive sleep apnoea (OSA) is a condition that affects around one in 20 children. In~     children with OSA, repeated episodes of airway obstruction can severely disturb and fragment~     sleep, leading to subsequent cognitive and behavioural problems .~      Epilepsy affects 60,000 children in the UK and up to 30% of children with epilepsy have~     learning problems. Evidence suggests that OSA is more common in children with epilepsy, such~     that sleep disturbance could account for some of the learning problems they experience.~      The aim of this study is to determine the prevalence of OSA in children with epilepsy. The~     investigators plan carry out detailed sleep studies in children with epilepsy and healthy~     controls to determine if children with epilepsy are more likely to have OSA than healthy~     children of the same age.~      OSA is almost always treatable and the benefits of detecting and treating the condition in~     healthy children are well-established. If OSA proves to be a common finding in children with~     epilepsy, it will be important to carry out further studies to see if treating the condition~     has beneficial effects on learning and behaviour. This project could lead doctors to target~     sleep-disordered breathing as a way of improving learning outcomes in children with epilepsy.~   "
35354|NCT03103828|"~     The purpose of this study is to figure out the best way to help veterans do advance care~     planning. This study will examine the effects of two theory based behavior interventions by~     randomizing veteran into 4 groups to see which veterans will complete the 4 step process of~     advance care planning.~   "
35355|NCT03103815|"~     The primary objectives of this study are to determine the safety and efficacy of Amivita, a~     compound of amino acids and vitamines in patients with Amyotrophic lateral sclerosis~     (ALS)ALS. The secondary objectives are to measure quality of life before and during~     intervention. This is a self-controlled clinical trial. Twenty patients in our ALS center who~     are already receiving riluzole or other treatments but the condition is worsening will~     receive treatment for 1o months. The evaluating investigators will be blinded to treatment~     assignment. Primary outcome measures will be adverse events, the ALS Functional Rating~     Scale-Revised (ALSFRS-R), and survival. Subjects will also be assessed at enrollment and at~     study end for weight loss, forced vital capacity (FVC), quality of life and grip strength.~   "
35356|NCT03103802|"~     This study is to compare the diagnostic accuracy of digital models obtained via 10~     digitization techniques to the reference standard of orthodontic plaster model through dental~     measurements~   "
35357|NCT03103789|"~     The objective of this study is to design and use a novel, minimally invasive mucosal~     impedance (MI) technology to inexpensively and accurately test mucosal health in suspected~     gastroesophageal reflux disease (GERD) and nonerosive reflux disease (NERD) patients as~     compared to those without GERD.~   "
35358|NCT03103776|"~     Autoimmune thyroiditis and goitres are frequent pathologies. On a predisposing genetic~     ground, environmental factors are potentially at their origin. Viral infections are the main~     factors involved in autoimmunity (herpes virus, viral hepatitis C, Erythrovirus B19 ..).~     However some viruses have an oncogenic potential and could be involved in goitrigenesis. It~     is also possible that some viruses are specifically implicated in the pathogenesis of Graves'~     disease or Hashimoto thyroiditis which combines goitre and autoimmunity.~      The intrathyroidism of the viral genome of a polyomavirus, the BK virus, has recently been~     reported in patients with goitre or cancer. The BK virus is a small ubiquitous virus of 40 nm~     diameter with double-stranded DNA contained in a non-enveloped icosahedral capsid. It is~     mainly known for triggering renal and bladder pathologies including urothelial tumors in the~     immunocompromised patient, tubulo-interstitial nephropathy in the renal transplant patient,~     as well as hemorrhagic cystitis in the patient grafted to the bone marrow.~   "
35359|NCT03103763|"~     This study is designed to evaluate the efficacy and safety of warfarin anticoagulation in the~     very old and attempt to identify risk factors which may impede safe and effective~     anticoagulation.~   "
35360|NCT03103750|"~     Specific Aim 1: As part of a within-subject, two-days, study design, to determine whether~     acute calcitriol (vs. placebo) pre-treatment is associated with greater amphetamine~     (Amp)-induced dopamine (DA) release in the caudate, putamen, ventral striatum (VST), and~     substantia nigra / ventral tegmental area (SN/VTA) of healthy human subjects.~      Specific Aim 2: To determine whether acute calcitriol (vs. placebo) pre-treatment is~     associated with better performance on a test of attention (e.g., the continuous Performance~     Task or CPT-AX), after treatment with amphetamine. Hypothesis: Investigators hypothesize that~     Subjects pre-treated with calcitriol will have faster reaction times/higher accuracy on the~     CPT-AX vs. subjects pre-treated with placebo, after treatment with amphetamine.~   "
35361|NCT03103737|"~     The aim of this study is to test the efficacy of a brief psychological intervention composed~     by two therapeutic modules (virtual environments and reminiscence techniques) for the~     promotion of wellbeing of hospitalized adult cancer patients. Participants are randomly~     assigned to 2 conditions: intervention condition and control condition.~   "
35362|NCT03103724|"~     Open label, single arm, phase II multicentre study designed to determine the clinical~     benefit, as measured by 3-months disease control rate (DCR) provided by enzalutamide in~     metastatic Castration Resistant Prostate Cancer patients with at least one visceral site~     involvement.~   "
35363|NCT03103711|"~     The aim of this study is to analyze the effect of a brief psychological intervention~     supported by Information and Communication Technologies, on the subjective well-being of~     hospitalized cancer patients. Participants are randomly assigned to one of 2 conditions:~     Intervention condition (4 Virtual reality sessions) and Control condition (waiting list~     control group).~   "
35381|NCT03103477|"~     The investigator's hypothesis is that smoking induces inflammation in the bladder wall. This~     may predispose to the development of Interstitial cystitis(IC) / bladder pain syndrome(BPS).~     Previous research has linked one the Platelet Activating Factor - PAF to interstitial~     cystitis. The investigators will study a limited number of patients to determine whether PAF~     is stable in urine and whether special precautions (for example - immediate freezing in~     liquid nitrogen) is necessary for accurate measurement of PAF in the urine.~      Patients who are presenting for an office visit will be asked to donate at least 50 ml of~     urine.~      A separate group of patients who are scheduled for surgery, are also being asked to donate~     around 25 ml of urine during surgery.~      No patient data other than group assignment, whether they smoke or if they have or not have~     interstitial cystitis will be recorded.~   "
35364|NCT03103698|"~     The intraoperative assessment of analgesia remains problematic and no analgesia monitor is~     used in routine practice. Currently, this assessment is based on hemodynamic changes,~     although hypertension or tachycardia is neither sensitive nor specific. An overdose in~     opioids exposes to many side effects ranging from respiratory depression to phenomena of~     post-operative hyperalgesia. Conversely, an under-dosage in opioids is at the origin of a~     nociceptive stress whose neurovegetative and hormonal response can aggravate post-operative~     morbidity or promote the occurrence of implicit memorization.~      Nociceptive influx can not be detected directly. However, its ascent to the somesthetic area~     of the cerebral cortex leads to physiological reactions that can be evaluated. In particular,~     there are numerous anatomical and functional interactions between the autonomic nervous~     system and the nociceptive tract in the brain stem. These interactions are mainly at the~     level of the gray periqueducal substance, the rostral ventro-lateral bulbous region, the~     solitary tract nucleus and the hypothalamus. The nociceptive influx thus leads to changes in~     the activity of the ANS. The study of changes in the ANS would therefore be a method of~     assessing the intensity of the nociceptive influx.~      This objective method can be used in the non-communicating or unconscious patient to evaluate~     the pain and to adapt the analgesic treatment to the best.~      Obese patients who receive surgical management often have comorbidities such as restrictive~     syndrome, or obstructive sleep apnea syndrome. They thus represent a target of choice in~     perioperative analgesic optimization in order to avoid respiratory complications that may be~     related to over or under assay of morphine such as atelectasis, alveolar hypoventilation.~      It is hypothesized that this device is more effective for the intraoperative evaluation of~     analgesia than the usual method based on hemodynamic changes in intraoperatively anesthetized~     patients for bariatric surgery.~   "
35365|NCT03103685|"~     This is a prospective randomized open-label blinded endpoint (PROBE) The study will be~     conducted in Maharaj Nakorn Chiang Mai hospital. The patients with dual-antipletlet who need~     dental procedure between Febuary 2017 until Febuary 2018 will be included in the study.~     Baseline characteristics of the enrolled patients including bleeding complication will be~     collected in each patient. To compare rate of significant bleeding from dental procedure~     between patient who need two antiplatelet and who stop P2Y12 inhibitors before procedure.~   "
35366|NCT03103672|"~     Percutaneous transhepatic cholangiography is a disturbing procedure for patients.~      TIVA with short-acting anesthetics such as propofol and remifentanil is characterized by~     hemodynamic stability and better compilation profile The purpose of this study; To compare~     total intravenous anesthesia with inhalation anesthesia in patients undergoing percutaneous~     transhepatic cholangiography under general anesthesia.~   "
35367|NCT03103659|"~     According to data from the French National Cancer Institute (INCA), almost one third of the~     cancers were diagnosed in overs 75 years patients in France in 2008. The elderly patients~     management is an important part in oncology daily practice.~      These last years, through the geriatric oncology development, collaboration between~     oncologists and geriatricians, the anti-cancer management and supportive care for elderly~     patients has evolved. The assessement of potential fragility helps to determine the cancers~     appropriate treatment plan.~      Studies have shown that alterations in geriatric fields, found through Comprehensive~     Geriatric Assessment (CGA) are associated with poorer survival, increased risk of~     chemotherapy severe toxicity and autonomy loss.~      Nursing home residents have often more frailties and functional problems than living at home~     elderly resulting in diagnostic and therapeutic cancer delay. In addition, nursing home~     residents must have appropriate treatment to preserve as much as possible their quality of~     life.~      Transversal Onco-Geriatrics Unit (UTOG), Day Hospital (HDJ), External Geriatric Mobile Unit~     (EMGE) of the Internal Medicine, Geriatric and Therapeutic Department of the Marseille~     hospital propose to organize a personalized care course for nursing home residents with~     cancer to minimize the diagnostics delay, facilitate their management in oncology and~     maintain their quality of life.~      Elderly patient with suspected cancer is oriented by EMGE to HDJ to realize an oncological~     and geriatric assessment. Patient would be supported by UTOG and would have access to~     technical platform.~      According to his cancer and nursing home location, the nearest reference center would be~     offered.~      Treatment or course of action (monitoring, palliative care …) would be decided in~     onco-geriatric multidisciplinary meeting (RCP) (organized by Onco-Geriatric Coordination Unit~     UCOG PACA west) and programmed and fast hospitalization would be organized in the reference~     center.~      When returning in nursing homes, elderly patient would be revalued by EMGE to continue~     therapeutic management and personalized care plan. The aim of this management is to allow a~     shorter hospitalization and maintain the quality of life of frailty patient during cancer~     treatment.~   "
35368|NCT03103646|"~     This study will investigate the effect of multiple doses of the strong P450 enzyme inhibitor~     itraconazole on the pharmacokinetics of Lu AF35700 in healthy subjects.~   "
35369|NCT03103633|"~     Anesthesia-related factors have been linked to poor perioperative outcomes. Our observational~     study suggested that the cumulative duration of a triple-low state (intraoperative low MAP,~     low BIS, and low Ce) was associated with poorer 30-day mortality.This randomized, prospective~     study based on individualized Oxygen dynamics is designed to confirm this association.~   "
35370|NCT03103620|"~     A multi-center, prospective, consecutive enrolled, observational registry. The population~     being studied includes all patients undergoing treatment of de novo lesions in native~     coronary vessels, saphenous vein graft and/or arterial bypass conduits with the COBRA PzF~     coronary stent system. The registry will primarily assess the rate of MACE (cardiac death,~     myocardial infarction and clinically driven target lesion revascularization.~   "
35371|NCT03103607|"~     There is a general belief among physicians involved with Graves' orbitopathy (GO) that this~     syndrome is somehow chronic, namely that the patient's eyes do not return the way they were~     before GO appeared.~      The general impression that comes from the available studies is that the eyes of GO patients~     do not return to normal even after a very long time since the disease appearance under the~     physician's point of view, although a discrete proportion of patients feel so. However, no~     studies are available in which the issue was examined with both objective criteria and~     self-assessment.~      The present study design was to investigated the disappearance of GO, regardless to~     treatment, in all consecutive patients with a history of GO of at least 10 years who came for~     a follow-up visit to our GO clinic over a period of 5 years.~   "
35372|NCT03103594|"~     The purpose of this research study is to evaluate the efficacy of intravesical botulinum A~     toxin and DMSO in women with bladder pain syndrome who have not responded to first-line~     treatments. Bladder pain syndrome is suprapubic pain with bladder filling as well as~     frequency, urgency, and nocturia in the absence of urinary tract infection or other~     pathology. DMSO has been shown to reduce pain in women with bladder pain syndrome as well as~     increase bladder absorption of various drugs. Botulinum toxin A has also been shown to~     improve pain in women with bladder pain syndrome when injected into the bladder suburothelium~     via a cystoscope. The main objective of this study is to assess if DMSO can deliver botulinum~     toxin to the suburothelium of the bladder to produce the same effect as direct injection of~     Botulinum toxin and a better effect than DMSO alone.~   "
35373|NCT03103581|"~     The objective of this study is to evaluate the safety and efficacy of BLI4700 as a bowel~     preparation prior to colonoscopy in adult patients.~   "
35374|NCT03103568|"~     An open-label, non-randomized, 2-arm, 2-period fixed sequence phase 1 study to evaluate the~     potential inhibition of nitisinone on cytochrome P450 2C9, 2D6, and 2E1 and the organic anion~     transporters OAT1 and OAT3 in healthy volunteers~   "
35382|NCT03103464|"~     Prior to discharging admitted patients, current UAB Hospital policy recommends physical~     therapy intervention for patients with impaired functional mobility. However, UAB Hospital~     currently does not have a standardized physical therapy protocol to rehabilitate admitted~     patients with impaired functional mobility who require moderate assist (defined as physical~     therapist expending 25-50% effort to assist the patient in standing). In order to reduce the~     effect of impaired mobility, numerous interventions have been employed at UAB. As a result,~     there is great variability of treatment procedures performed by various physical therapists~     to help moderate assist patients return to their level of functioning prior to hospital~     admission. The purpose of the study is three-fold: 1) to evaluate whether a proposed physical~     therapy protocol using a commercially available medical device, the Movi chair, contributes~     to improved mobility for moderate assist patients, 2) to investigate how patient rate of~     rehabilitation to prior level of functioning is similar/different with the proposed physical~     therapy protocol using Movi vs the current non-standardized practice for moderate assist~     patients, and 3) to compare patient confidence in physical therapy with Movi vs the current~     non-standardized practice using survey for moderate assist patients. In addition, we will~     track participant's disposition i.e. continued motor and functional change following~     discharge from the hospital through review of physical therapy records.~   "
35383|NCT03103451|"~     This is an open label, phase 1, 3+3, placebo-controlled dose escalating study of~     tolerability, safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single~     subcutaneous injection of the novel monoclonal bispecific antibody against human IL-17/TNFa.~     The study will enroll 28 healthy male volunteers.~   "
35384|NCT03103438|"~     This is an open label, phase 1, 3+3 dose escalating study of tolerability, safety,~     pharmacokinetics, pharmacodynamics and immunogenicity of a single subcutaneous injection of~     the novel monoclonal antibody against the interleukin-6 receptor - BCD-089. The study will~     enroll 19 healthy male volunteers.~   "
35385|NCT03103425|"~     The purpose of the study is to develop an emergency electroencephalogram (EEG) device,~     StatNet, that can be placed quickly by minimally-trained personnel and interpreted remotely~     for rapid identification of seizures.~   "
35386|NCT03103412|"~     This study is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of~     single-dose TD-3504 and single dose 15N2-tofacitinib in healthy subjects and subjects with~     UC. The relative bioavailability of tofacitinib released from TD-3504 compared to~     co-administered oral heavy-labeled tofacitinib (15N2-tofacitinib) will also be evaluated.~   "
35387|NCT03103399|"~     The purpose of this study was to investigate the effect on the wearing-off phenomenon of 3~     different doses of nebicapone (NEB 50 mg, 100 mg and 150 mg), compared with entacapone and~     placebo when dministered concomitantly with existing treatment with levodopa plus a dopa~     decarboxylase inhibitor (DDCI: carbidopa or benserazide).~   "
35388|NCT03103386|"~     The investigators hypothesize that long-term fermented high-fibre rye intake may reduce the~     Helicobacter pylori infection through dampening inflammation and thereby leading to lower~     adherence of the bacteria to surfaces.The investigators further hypothesize that that~     inflammation could be a potential causal link between HP infection and insulin resistance, a~     risk factor for type 2 diabetes and cardiovascular disease.~   "
35389|NCT03103373|"~     The study is a clinical trial, prospective and randomized of 60 patients of both genders,~     aged between 18 and 80 years, underwent major abdominal surgery. This study aims to compare~     plasma lactate levels in patients underwent major abdominal surgery (colectomy, gastrectomy,~     esophagectomy, pancreatectomy, Wertheim Meigs, liver and spleen surgeries) monitored by~     echocardiography or by conventional techniques (mean arterial pressure , Central venous~     pressure).~   "
35390|NCT03103360|"~     During routine general anesthesia (not standardized, left to the discretion of the attending~     anesthesiologist), pupillary pain index was measured one minute before skin incision. Then,~     variations in heart rate, blood pressure and bispectral index during the three minutes~     following skin incision were recorded, as well as the occurrence of movements.~   "
35391|NCT03103347|"~     The investigators are studying the relationship between a certain oscillatory brain rhythm~     (13-30 cycles/sec) that emerges prominently in patients with Parkinson's disease and symptoms~     of slowness of movement. The investigators are recruiting patients with a range of severity~     of Parkinson's disease symptoms to perform electroencephalography (EEG), in which the study~     team records brain waves using electrodes placed on the scalp, while patients sit at rest or~     perform certain hand tasks. The investigators will analyze the recorded brain waves to~     extract the brain rhythm of interest and relate it to motor symptom severity as well as study~     its behavior during rest and hand movement.~   "
35392|NCT03103334|"~     The objective is to determine whether the test product, Methotrexate 40 mg/mL solution for~     injection administered subcutaneously by the prefilled and needle-free delivery system~     Zeneo®, and the reference product, Methotrexate Biodim® 25 mg/mL, solution for injection~     administered subcutaneously by a conventional syringe with needle are bioequivalent.~   "
35393|NCT03103321|"~     This randomized phase III trial studies how well decision aids work in improving knowledge in~     patients with newly diagnosed prostate cancer. Decision aids may improve patients' knowledge~     of their condition and options for treatment, and may also help when talking with their~     doctor.~   "
35394|NCT03103308|"~     This study will determine if a structured walking intervention will help maintain or improve~     physical activity levels, physical function and quality of life in hematopoietic stem cell~     transplant patients.~   "
35395|NCT03103295|"~     This study investigates safety and efficacy of traumatic bone defects treatment with use of~     3D tissue engineered bone equivalent (3D-TEBE).~      The aim of this study is to evaluate 3D-TEBE transplantation as a safe and efficient~     treatment for patients with traumatic long bone defects of critical size.~   "
35396|NCT03103282|"~     The objective of this post-market clinical follow-up study is to collect medical information~     on patients implanted with PuraStat®, according to each participating institution's~     procedures and standards of care.~   "
35419|NCT03102983|"~     The aim of our study is to show by fMRI the involvement of the motor system in the perception~     of speech, and more particularly how this implication is modulated by the degree of~     prototypicity of the stimuli.~   "
35397|NCT03103269|"~     The prevalence of overweight among adolescents (BMI-for-age %tile over the 95th percentile)~     has more than tripled over the past 3 decades in the US. Overweight and physical inactivity~     disproportionately affect low- income, female, African American adolescents.~      A prior health-promotion/ obesity-prevention program for adolescents developed and tested by~     our group (Challenge!) showed that adolescents who received the intervention were less likely~     to become overweight or obese over 2 years when compared to the control group. This~     intervention was administered one-on-one to adolescents in their homes or community by a~     college-aged mentor.~      Schools are an ideal setting for interventions because the effect can be far-reaching and~     sustainable. School-based obesity-prevention interventions have thus far shown modest~     results.~      The purpose of this study is to evaluate the impact of a multilevel intervention that~     includes both the Challenge program administered in a small group format after school using~     mentors and teachers and a school-wide environmental change on adolescent females' body~     composition, diet, and physical activity. The intervention is targeted to 6th and 7th grade~     female students. The small group intervention is conducted over 12 weeks and includes goal~     setting focusing on healthy diet and physical activity, along with membership and weekly~     trips to the YMCA. The environmental intervention includes a Health and Activity Committee~     (HAC), comprised of 8th grade female students (popular opinion leaders), school personnel,~     parents, and community members. The HAC develops school-wide health promotion messages and~     activities. Parents of participating 6th and 7th grade girls provide information on family~     variables. The hypotheses are that females who receive the small group or environmental~     intervention are at less risk of weight gain (overweight) than females in the control small~     group condition, that females in environmental schools are at less risk of weight gain~     (overweight) than females in the control environmental condition, and that females who~     receive both the small group and environmental intervention are at the lower risk of weight~     gain (overweight) than females who receive only the environmental or small group intervention~     or neither intervention.~   "
35398|NCT03103256|"~     The purpose of this study is to determine superiority of YHP1701 comparing to each~     monotherapy in patient with hypertension and primary hypercholesterolemia.~   "
35399|NCT03103243|"~     The study tests whether contemplative-based intervention can modify pathogenic processes in~     participants with Lupus. Techniques such as meditation, mindfulness and yoga may have an~     impact on the disease and may decrease psychological distress, increase self-regulation~     capabilities, and reduce pain. Additionally, incorporating patients' caregivers may~     strengthen their relationships and, thereby, improve their health and well-being.~   "
35400|NCT03103230|"~     The purpose of this study is to study, among the aphasic person, if motor function ( studied~     by Motor Evoked Potentials) performed within the first 14 days after a stroke can predict a~     good recovery from aphasia 6 months of the initial episode.~   "
35401|NCT03103217|"~     Pregnancy is a time of significant adjustment and uncertainty. Anxiety is common among this~     group and is associated with poor cognitive and physical outcomes for both the mother and~     child. Few trials have been conducted to ascertain the effectiveness of brief psychological~     interventions designed to alleviate general anxiety, labour and pregnancy specific anxiety~     and promote well being.~      The aim of this project is to establish if a brief Cognitive Behavioural Therapy treatment is~     effective in reducing general anxiety during pregnancy. The study will also explore whether~     the treatment has an impact on reducing pregnancy specific and labour related anxiety and~     reducing medical intervention.~   "
35402|NCT03103204|"~     Obesity and gum diseases are highly prevalent in all parts of the world. Obesity can~     negatively influence severity and progression rates of gum diseases. Presence of fat in the~     body determines a general systemic state of inflammation. On the other hand, when gum~     diseases are successfully treated systemic and local inflammation decrease. In addition~     reductions in glycemic blood levels are also observed after treatment. Periodontitis is one~     type of gum disease that is associated with bone loss. It could be treated within 24 hours by~     using a protocol, which combines dental debridement and mouthwash. This treatment protocol,~     named one-stage full-mouth disinfection works well in individuals of normal weight.~     However, there is no information whether it is effective in obese individuals or not. Also,~     it should be clarified if obesity influences response to periodontal treatment. This study~     hypothesized that obesity impair response to periodontal treatment. Therefore, the effects of~     the protocol one-stage full-mouth disinfection will be evaluated in obese individuals and~     normal weight controls. This evaluation will be based on the monitoring of several clinical,~     microbiological and biochemical parameters throughout 9 months. Participants will answer~     validated questionnaires to evaluate if treatment of gum disease would be able to improve~     individual's quality of life. Study population will be composed of 90 to 100 obese~     individuals (males or females; > 18 years of age; smokers or non smokers; > 12 natural~     teeth). Participants will be classified into 5 groups according to their body mass index in~     normal weight (n = 15 to 20); overweight (n = 15 to 20); obesity I (n = 15 to 20); obesity II~     (n = 15 to 20); obesity III (n = 15 to 20). Examinations will be performed before treatment~     and also 3, 6 and 9 months after treatment. This study will contribute to the knowledge on~     how obese individuals respond to this specific treatment protocol. Also, having normal weight~     individuals as controls the present study will contribute to a better understanding about~     obesity, in its different severities, influence on periodontal treatment.~   "
35403|NCT03103191|"~     KL-6 may be a useful biomarker in patients with interstitial lung disease, but there is~     limited information in non-Asian populations. Therefore, it is necessary to carry out studies~     in other populations to confirm the diagnostic values of the biomarker and its prognostic~     implication.~      Hypothesis KL-6 may be a useful biomarker in the management of interstitial lung diseases.~     But it is necessary to know more about its utility in the European population.~      Study Objectives:~        -  To determine the concentration of KL-6 in serum of patients with pulmonary fibrosis at~          the time of diagnosis compared to patients without pulmonary fibrosis~        -  Diagnostic yield of KL-6 in patients with pulmonary fibrosis.~        -  Correlation of KL-6 values with functional and radiological parameters of disease~          severity at diagnosis.~        -  Correlation of serum KL-6 values with the evolution of the disease.~   "
35404|NCT03103178|"~     The purpose of the present study is to advance in the knowledge of quality of life in~     patients with ILD by translating a ILD quality of life questionnaire.~      There are no specific tools validated in Spanish to evaluate the quality of life in patients~     with ILD, although these measures are useful for an comprensive evaluation of these patients.~      Patients with ILD have a significant impact on their health. If we improve our Knowledge of~     the different domains affected by the disease, and not only in the pathophysiological ones,~     we will be able to develop tools to improve their management.~   "
35405|NCT03103165|"~     SimCoach, a computer program featuring a virtual human that speaks and gestures in a~     videogame-like interface, is designed to encourage servicemembers to seek help to improve~     their psychological health.~   "
35406|NCT03103152|"~     To demonstrate the acceptability and feasibility of recruitment to a randomised~     chemoprevention study of standard (300mg) or low dose (100mg) aspirin vs. placebo and/or~     Vitamin D3 vs. placebo in patients enrolled on an Active Surveillance programme for prostate~     cancer.~   "
35420|NCT03102970|"~     The prevalence of chronic obstructive pulmonary disease (COPD) is between 8 and 12% of the~     adult population. This prevalence is expected to increase over the coming decades due to the~     aging of the population and the continued exposure to risk factors for the disease. The~     evolution of COPD is marked by the occurrence of exacerbations of varying severity and~     patients are frequently admitted to the emergency department for evaluation, treatment and /~     or hospitalization. Admission in emergency department for COPD exacerbation represents~     approximately 1% of emergency admission.~      Chronic pain is common in patients with Chronic Obstructive Pulmonary Disease (COPD). The~     pain intensity may increase during acute episodes of exacerbations. This study is aimed to~     compare pain intensity during exacerbation and stable phase of patients with chronic~     obstructive pulmonary disease (COPD).~   "
35407|NCT03103139|"~     1. Biliary duct injury are a relatively frequent complication of hepatobiliary surgery,~          most comonly laparoscopic cholecystecomy.~        2. Prior to the development of more sophisticated endoscopic interventions, repeat surgery~          was often necessary for the management of biliary leaks.~        3. Advances in technique and technology in gastroenterology endoscopy have largely replaced~          surgery as the first line intervention for biliary leak.~        4. Most practices utilize endoscopic plastic biliary stent placement alone and are~          efficacious and equivalent to the biliary stent placement with endoscopic biliary~          sphincterotomy.~        5. An area of variation is in whether biliary stent should cross the papilla ( with a~          shorter stent) versus the site of the bile leak (with a longer stent).~        6. Our objective is to assess whether placing a biliary stent across the leak versus across~          the papilla alone improves the treatment of biliary leaks.~   "
35408|NCT03103126|"~     The study aims to investigate whether 12 weeks of structured aerobic and resistance exercises~     completed at home can have a beneficial effect on the health of patients with type 2 diabetes~     compared to standard physical activity advice. The study will investigate whether the~     exercises can reduce factors such as patient's BMI, blood pressure and waist circumference,~     as well as blood glucose and insulin sensitivity. Participants will use pedometers and~     Therabands to carry out their exercises.~      This will be compared to giving participants a physical activity advice sheet and no~     structured exercise examples.~   "
35409|NCT03103113|"~     The purpose of this study was to assess the relationship between infertility blood test~     results and outcomes of pregnancy and alive birth of women who underwent with or without~     intravenous immunoglobulin (IVIG) before in vitro fertilization.~   "
35410|NCT03103100|"~     This study will compare and determine the most ideal local anesthetic (LA) solution to~     activate a labor epidural: lidocaine, bupivacaine, or a combination of bupivacaine plus~     lidocaine.~   "
35411|NCT03103087|"~     The purpose of this study is to determine the benefit and safety of relugolix 40 mg once~     daily co-administered with low dose estradiol and norethindrone acetate compared with placebo~     for 24 weeks on heavy menstrual bleeding associated with uterine fibroids. Additionally, this~     study is designed to evaluate the benefit of relugolix 40 mg once daily for 12 weeks followed~     by 12 weeks of relugolix 40 mg once daily co-administered with low dose estradiol and~     norethindrone acetate compared with placebo for 24 weeks in the same population.~   "
35412|NCT03103074|"~     Randomized double blind placebo controlled pilot study/proof of concept-study to see if~     intradermal injection with Botulinum toxin B is an effective treatment of Hidradenitis~     suppurativa~   "
35413|NCT03103061|"~     The purpose of this study is to evaluate the feasibility, tolerability, safety, and image~     quality of low-radiation, dynamic perfusion CT of the heart in patients with suspected~     ischemic chest pain and a moderate or severe stenosis seen on coronary CTA. Secondary aims~     include the assessment of the diagnostic accuracy of CT perfusion imaging compared to either~     SPECT or invasive angiography.~   "
35414|NCT03103048|"~     This study will be featured as a randomized controlled. As the dependent variable, was~     considered isometric grip manual force. As independent variable, the presence or absence of~     forearm bandage in the fist flexor region of the volunteers.~   "
35415|NCT03103035|"~     The purpose of this study is to determine if a nutrition intervention provided through a~     healthy eating blog is feasible and acceptable.~   "
35416|NCT03103022|"~     Patent ductus arteriosus or PDA is a blood vessel that connects the right and left side of~     the heart that usually closes after birth but remains open in some premature infants born~     before 30 weeks' gestation. When this blood vessel remains open for a long time, it may cause~     problems such as bleeding in the lung and brain, lung injury due to prolonged need of~     ventilator, and poor kidney function. It sometimes becomes necessary to close this blood~     vessel in the preterm infant. Currently, this blood vessel can be closed either by medication~     or surgery. Pain medications such as Ibuprofen and Indomethacin are routinely used~     medications to close PDA. However, in the last 5 year, acetaminophen has been found as an~     alternative medication to close PDA in preterm infants. In multiple studies, acetaminophen is~     found to be a safe alternative medication with lower side effects than current standard~     management. Intravenous Ibuprofen is approved by FDA to treat PDA in preterm infants.~     Although not approved by FDA, oral ibuprofen is being used for the management of PDA.~     However, the success rate of a single medication is approximately 70%. Both medications have~     been used in the previous clinical studies to treat the same condition in the preterm infants~     and fewer side effects were reported. Mechanism of both medications to close PDA is different~     and may work more effectively together than single medication alone. In this study, the~     investigator are going to use these two medications (Ibuprofen and Acetaminophen) at the same~     time if the child needs treatment and is eligible to participate in this study. This study is~     based on the assumption that by using both medications at the same time, investigator can~     close this blood vessel more effectively than with either drug alone.~   "
35417|NCT03103009|"~     Somatostatin analogues are a last resort for medical intervention in hyperinsulinemic~     hypoglycemia (HH). The hypoglycemia is very debilitating and can be even life threatening.~     There is limited experience with pasireotide in hyperinsulinemic hypoglycemia (only one~     publication); there is more experience with octreotide, both in adults and children~     successful interventions with octreotide in hyperinsulinemic hypoglycemia have been~     published. Pasireotide via its different somatostatin receptor binding profile has clear~     effects on insulin, glucagon and incretin secretion and can ultimately lead to hyperglycemia.~     This mode of action (especially the effects on insulin and incretin secretion) could be very~     useful in the setting of hyperinsulinemic hypoglycemia.~   "
35418|NCT03102996|"~     The aim of this study is to test if alkali treatment will preserve kidney graft function and~     diminish the progression of chronic kidney disease in renal transplant patients. Additionally~     the underlying mechanisms of nephrotoxicity of metabolic acidosis will be investigated in~     this cohort.~      This study is a multi-center, prospective, randomized, single-blind (patient),~     placebo-controlled interventional trial to test the superiority of alkali treatment in~     comparison to placebo on preservation of kidney function in 300 kidney transplant recipients.~     The duration of the study will be 2 years for the individual participant. The patients will~     be randomized into 2 arms: intervention arm (sodium hydrogen carbonate, product:~     Nephrotrans®) and placebo arm (placebo comparator).~      Several studies in CKD (chronic kidney disease) patients have shown that alkali therapy slows~     progression of CKD.~   "
35422|NCT03102944|"~     Main objective is to determine normal values for Brain Natriuretic Peptide (BNP) levels for~     the Minicare BNP using K2-EDTA (ethylenediaminetetraacetic acid ) venous whole blood and~     K2-EDTA plasma samples from healthy subjects.~      K2-EDTA whole blood and K2-EDTA plasma samples from approximately 150 normal healthy~     volunteer, preferably 50% men and 50% women, will be analysed using the Minicare BNP system.~     This will be a single-center study. The study will consist of a 1-day visit for each study~     subject on which screening based on a questionnaire, blood draw and discharge will occur. For~     each eligible subject, K2-EDTA whole blood will be collected and both K2-EDTA whole blood and~     K2-EDTA plasma will be analyzed using the Minicare BNP. Blood donors, presenting voluntarily~     at one of the Sanquin posts in, the Netherlands (e.g Eindhoven) will be checked on health~     status and selected based on 2 questionnaires. The collected K2-EDTA whole blood tubes from~     eligible subjects will be transferred from the Sanquin posts to Philips Eindhoven for~     Minicare BNP testing. From one subject, both K2-EDTA whole blood and K2-EDTA plasma will be~     measured in singleton. K2-EDTA whole blood and plasma will be measured within 6 hours after~     blood collection. The data obtained will be used for determination of normal values of BNP in~     a healthy population. Leftover plasma samples (without cells/ RNA/DNA) will be aliquoted and~     stored at Philips for potential future analysis/ projects). Testing will be done according to~     a DRAFT Instructions for use (IFU) of the Minicare BNP.~   "
35423|NCT03102931|"~     The overall objective of this clinical study is to determine if smokers who switch from their~     usual high reactive oxygen and nitrous oxide species (ROS/NOS) products to a low ROS/NOS~     product exhibit increased or decreased levels of oxidative stress/damage, respectively.~   "
35424|NCT03102918|"~     Investigators aim to determine Epidiolex's promise as a pharmacotherapy for cannabis use~     disorder. Investigators hypothesize that Epidiolex, when added to medical management, will~     result in greater reductions in marijuana use compared to placebo as measured by the 2~     primary outcome measures: 1) quantitative THC levels and 2) self-report by Timeline Follow~     Back. Secondary outcome measures will include treatment retention, patient satisfaction,~     cannabis withdrawal, cannabis craving, depressive symptoms, anxiety symptoms, , compliance,~     and cigarette use.~   "
35425|NCT03102905|"~     To look for the replication of HHV6 by PCR in the skin, in these patients with haemopathies~     presenting an exanthema. This will make it possible to evaluate the prevalence of the~     positivity of this PCR in the skin. Then the investigator can investigate whether there is an~     association between the positivity of HHV6 PCR in the blood and / or skin and the viral~     etiology of the exanthema. If this association exists, it will make it possible to improve~     the diagnosis in the context of the exanthema and thus to improve the therapeutic management~     of these patients.~   "
35426|NCT03102892|"~     The aim of this study is to evaluate adjuvant effect of antimicrobial photodynamic therapy in~     periodontal treatment and salivary status of type 1 diabetes patients.~   "
35427|NCT03102879|"~     To compare the dental survival in a period of 2 years of mature permanent teeth with apical~     lesion following the administration of encapsulated Mesenchymal Stem Cells under a~     regenerative endodontic procedure and a conventional root canal treatment.~   "
35428|NCT03102866|"~     This randomized pilot phase I/II trial studies how well aerobic and strength training~     exercise works in improving fitness and arm health during and after radiation therapy in~     patients with stage II-III breast cancer. Aerobic and strength training exercise training~     during and after radiation therapy may reduce treatment related toxicities and improve~     adherence to exercise long term in patients with breast cancer.~   "
35429|NCT03102853|"~     This project will examine whether long-term consumption of healthy Nordic foods can maintain~     a healthy weight also after weight loss, and decrease abdominal fat accumulation and~     cardiometabolic risk. The study will be performed with the aim to achieve a substantial body~     weight loss in the first phase by prescribing a standardized low caloric dietary formula. The~     follow-up phase will be a body weight-maintenance period and the subjects will be randomised~     to a healthy Nordic diet group and a control diet group. During the study body weight will be~     monitored and other measurements will include insulin sensitivity, blood lipids and~     inflammation markers.~   "
35430|NCT03102840|"~     Streptococcus pneumoniae is a type of bacteria that is carried (lives) in the nose of most~     individuals and can sometimes go on to cause severe infections such as meningitis and~     pneumonia. There are over 100 types of pneumococcus, and children in the UK have been~     routinely immunized against pneumococcal disease since 2006. A vaccine against 13 types of~     pneumococcus (PCV 13) was introduced into the UK in 2010, replacing a previous version that~     prevented 7 types.~      Pneumococcal carriage in the Thames Valley region has been studied over the last 7 years with~     carriage rates having been shown to be reflective of potential severe pneumococcal disease~     and hence vaccine effect.~      The main purpose of this study is to see whether the pneumococcal immunization program has~     changed the frequency and nature of pneumococcal bacteria carried by children, as this may~     give a clue as to what changes in pneumococcal disease are likely to be seen in the future.~     In addition, this study is especially timely given the possibility of a change in the PCV 13~     immunization schedule that is currently being assessed in the 'Sched3' Immunization study~     (NCT02482636). Obtaining accurate baseline data will be important in informing the~     interpretation of any subsequent data on carriage rates obtained following introduction of~     the new schedule.~      This study will enroll approximately 1600 children aged 13 to 48 months living in the Thames~     Valley and South Midlands and which have had three doses of 13-valent pneumococcal conjugate~     vaccine. The study consists of one visit done at a convenient venue (GP surgeries,~     educational/ play settings, or home) where a single nasal swab and an optional finger-prick~     blood sample for a sub-set of 632 participants, will be performed. No additional follow-up is~     needed. The study recruitment period will be done over 12 months.~   "
35431|NCT03102827|"~     To demonstrate the effectiveness and safety of nocturnal ventilation with oxygen (HFT -~     high-flow-therapy) for the treatment of CSA in patients with HFrEF compared to placebo~     (patient will breathe ambient air via nasal cannula that is not connected to the~     high-flow-device).~   "
35432|NCT03102814|"~     The main aim of this multi-centre stepped wedge randomized controlled trial is to improve the~     quality, professional practice and cost-effective utilization of health care resources by~     evaluating if a new rehabilitation program aimed at bridging gaps in rehabilitation across~     levels of care may increase and/or prolong the effect of rehabilitation.~   "
35440|NCT03102710|"~     The aim of this study is to use a brain stimulation tool called transcranial direct current~     stimulation (tDCS) to investigate the analgesic (reducing sensitivity to pain) effects of~     lidocaine cream and the hyperalgesic (increasing sensitivity to pain) effects of capsaicin~     cream using a neutral cream as a control. tDCS stimulation has been shown to temporarily~     influence the way the stimulated part of the brain functions. With this method, the~     involvement of specific parts of the brain can be investigated in the working of the brain as~     a whole.~   "
35433|NCT03102801|"~     Glucose is a sugar carried in the blood stream that body uses for energy. If someone has~     diabetes, blood glucose level can be erratic, sometimes becoming very low this is called~     Hypoglycaemia (or a hypo), and can happen when blood glucose levels drop below 4 mmol/l.~      So far in order to prove that a hypo happened for a patient, blood glucose level can only be~     measured at time of the hypo and not after it.~      In this study we are trying to identify certain chemical substances (biomarkers) in diabetic~     patients that may be measured in blood tests of the patient up to after 24 hours of the hypo~     and if we could prove that a hypo has happened we could adjust tablets and or insulin dosage~     in a way to prevent further hypos.~      The study will be conducted in the Diabetes Centre in Hull Royal Infirmary and will involve~     three visits to the diabetes centre. The study can finish in a week time after the first~     visit.~      Visit 1 is the screening visit to identify eligibility to take part in the study. Visit 2~     insulin infusion will be given to make participants blood sugar level fall lower than normal~     for a short time and corrected quickly afterward. This is a stress for participant's body and~     should stimulate certain chemicals that we are trying to identify during hypo.~      In Visit 3, the main purpose of this visit which is done 24 hours after insulin infusion is~     to take a blood sample and check how participants is after visit 2.~      We will recruit 25 Type 2 Diabetic patients and 25 none diabetics to compare both results.~      Both groups should not have ischemic heart disease, underactive thyroid or seizures and on~     stable dosage of medications.~   "
35434|NCT03102788|"~     The main aim in this randomized controlled trial is to improve access to safe and effective~     care, professional practice and cost-effective utilisation of health care resources by~     testing if occupational therapist-led care is as effective and safe as rheumatologist-led~     care for people with hand osteoarthritis.~   "
35435|NCT03102775|"~     In a cluster-randomized design, the study evaluates the effectiveness of a skill- training~     program for social work professionals with the aim of improving the follow-up of low income~     families within Norwegian labor and welfare services. While the Norwegian Labor and Welfare~     Administration are responsible for developing and implementing the program, researchers at~     Oslo and Akershus University College are conducting an independent evaluation of its~     effectiveness. By close follow up and better coordination of existing services the model aims~     to improve the financial and housing situation of the family, labor market attachment among~     the parents and the social inclusion of children. The cluster-randomized field experiment~     will take place over a 40-month period, involving 29 labor and welfare offices, 58 family~     coordinators and, based on estimations, 650 families. The research is funded by the Norwegian~     Labor and Welfare Administration.~      The project is financed by Labour and Welfare Administration and led by Ira~     Malmberg-Heimonen, Faculty of Social Sciences. Participants in the project are: Ira~     Malmberg-Heimonen (project leader), Anne Grete Tøge, Krisztina Gyüre, Knut Fossestøl,~     Marianne Rugkåsa, Berit Bergheim and Tone Liodden.~   "
35436|NCT03102762|"~     To evaluate the safety and efficacy of intra-cavernosal Botulinum toxin injection as an~     alternative line of treatment in patients with erectile dysfunction - not responding to oral~     PDE5i - through cavernosal smooth muscle relaxation.~   "
35437|NCT03102749|"~     New insights of small airway contribution to asthma have been gained. Poor levels of control~     and recurrent exacerbations were shown to have the phenotypic counterpart of asthma with~     predominant small airway involvement. Very few pathological specificities were identified at~     this site: mast cells infiltration was suggested as the specific inflammatory change when~     compared to the proximal airways.Biomarkers in asthma are still complex to validate,~     especially in the blood, since compartmentalisation is intense in the lung and the airways, a~     property attributed to the filtering role of the lung to maintain homeostasis. Over the last~     few years, Fraction exhaled Nitric Oxide (FENO) was developed as a non-invasive and indirect~     reflection of airway eosinophilic inflammation]. In the blood, peripheral eosinophil counts~     were shown as a correct T helper 2 (TH2)-phenotype identifier but not perfectly related to~     airway eosinophilic infiltration. Club cell secretory protein (SCGB1A1) levels have been~     shown to have some relevance in asthma, chronic obstructive pulmonary disease (COPD), BOS,~     sarcoidosis, and lung cancer.A biomarker for small airway disease in asthma may improve the~     management of the disease, identify areas of therapeutic resistance and constitute a~     therapeutic guidance tool. In this study, investigators aimed to assess small airway~     involvement in asthmatic women as far as they could. For this purpose, investigators analysed~     trends in air trapping by acquiring expiratory CT slices at each dose during a~     bronchoprovocation test with metacholine. Biomarkers were subsequently tested and confronted~     to clinical and demographical characteristics in their ability to predict the small airway~     involvement index obtained at CT.~   "
35438|NCT03102736|"~     The purpose of this study is to test the effects of the medication ketamine and the~     medication called nitroprusside in patients with major depression. Ketamine has both good and~     bad effects. Some studies have shown that ketamine improves depression. However, studies have~     also shown that it causes strange and sometimes unpleasant sensations referred to psychotic~     or dissociative symptoms. An example of a psychotic symptom would be hearing or seeing~     something that in reality is not there. The study team would like to see if nitroprusside can~     prevent the reported bad effects of ketamine without blocking the reported good effects. This~     might make ketamine a better treatment for depression.~   "
35439|NCT03102723|"~     There remains a clinical need to improve health outcomes in patients with ischemic heart~     disease (IHD) the leading cause of death and disability in Singapore and worldwide. One~     neglected therapeutic target is 'myocardial reperfusion injury' in ST-segment elevation~     myocardial infarction (STEMI) patients treated by primary percutaneous coronary intervention~     (PPCI). This results in microvascular obstruction (MVO) and cardiomyocyte death and~     contributes upto 50% of the final myocardial infarct (MI) size. Cangrelor, a potent~     intravenous platelet P2Y12 inhibitor with rapid onset and offset of action, has been~     demonstrated in experimental animal studies to reduce MI size when administered prior to~     reperfusion. Whether Cangrelor given together with Ticagrelor would be more effective at~     reducing MI size in STEMI patients treated by PPCI is not known and is investigated in the~     Platelet Inhibition to Target Reperfusion Injury (PITRI) trial.~   "
35441|NCT03102697|"~     This is a cohort study with the objective of describing during a 12-month follow-up, weight~     loss in obese patients submitted to treatment using two consecutively air-filled IGB~     (Heliosphere® 600 cc and Heliosphere 720 cc) without any interval between the removal of the~     first and the placement of the second.~   "
35442|NCT03102684|"~     Limited studies have evaluated potential exposure to secondhand e-cigarette aerosol, an~     indication of impact on indoor air quality. Also limited are the studies regarding direct~     passive exposure of humans and most of these studies have limitations, such as the small~     number of participants, the different methodology and devices used, or the fact that they are~     laboratory studies, where exposure parameters differ significantly from the actual user's~     habit and device. Therefore, TackSHS Project has foreseen an intervention study of cross-over~     design in similar to real-life conditions that aims to assess the mediating effect of~     e-cigarette battery output on pulmonary outcomes and indexes to provide a better~     understanding of the extent to which passive exposure to aerosols produced by use of~     e-cigarette impacts exhaled NO and exhaled breath condensate metabolites.~   "
35443|NCT03102671|"~     The recurrence of major cardiac events after infarction is very high, in some populations up~     to 20% in the first year. Optimal secondary prevention as organized in cardiac rehabilitation~     centers is effective in reducing both morbidity and mortality. However, many studies have~     shown that the participation and adherence rate in CR-programs is low in most European~     countries. Therefore, novel ways of delivering secondary prevention using information~     technology and self-monitoring are being explored. Hence, this study will investigate the~     effectiveness of a mobile, patient tailored, app based multidisciplinary telerehabilitation~     program (HeartHab app) in improving exercise capacity, lifestyle and risk factors in patients~     with coronary artery disease in a post-rehabilitation setting.~   "
35444|NCT03102658|"~     Because micafungin is generally well tolerated and appears to have limited interaction with~     other drugs, it is a potential important agent in the treatment of invasive fungal~     infections. Although micafungin is approved for the treatment of invasive candidiasis, dosing~     guidelines for micafungin in (morbidly) obese patients are not available. Subsequently, the~     pharmacokinetic profile of micafungin (as well as other echinocandins) in this specific~     patient population is still largely unknown.~      To build a valid pharmacokinetic model, obese patients with a BMI ≥ 40 undergoing endoscopic~     gastric bypass surgery will receive a single dose of 100 mg or 200mg micafungin (besides~     standard anti-bacterial prophylaxis) and samples for a pharmacokinetic curve will be taken.~     These PK-values can then be compared to the PK in a normal-weight group which will receive~     100mg micafungin~   "
35445|NCT03102645|"~     A double-blinded, randomized, crossover study in healthy females with placebo and single dose~     imipramine 50 mg.~      Primary objective: Does imipramine increase the tone of the external urethral sphincter?~     Urethral Opening Pressure (UOP) is measured with Urethral Pressure Reflectometry (UPR). UOP~     increases correlate with effect in treating stress urinary incontinence. Can imipramine treat~     stress urinary incontinence? Secondary objective: Does imipramine increase the tone of the~     anal sphincter? The opening pressure is measured with Anal Acoustic Reflectometry (AAR). The~     investigators also wish to establish the within-subject standard deviation for AAR to enable~     power calculations in future studies.~   "
35446|NCT03102632|"~     Patients affected by Autosomal Dominant Polycystic Kidney Disease (ADPKD) need a safe and~     effective long-term treatment regimen. Unfortunately, there are still no disease-specific~     treatment for ADPKD approved in the US. A rational step towards identifying such agents is to~     test therapies that have a proven safety profile with mechanisms of action that can counter~     the disease progression.~      The purpose of this study is to investigate whether drinking increased amounts of water~     (water loading) might slow down polycystic kidney growth or kidney function decline. Water~     loading can cause the suppression of a pathway that causes fluid buildup and cyst growth.~     High water intake has been safely used in the clinical setting, such as in the case of kidney~     stone therapy. New York State tap water is widely available and safe, making it highly~     cost-effective as well.~   "
35447|NCT03102619|"~     Postoperative observation of patients is based on the Early Warning Score (EWS). By using~     continuous wireless monitoring of vital parameters it may be possible to predict the risk of~     complications after abdominal cancer surgery. The object of this pilot study is to test the~     equipment and methods for the next phases. Patients will be monitored for 4 days~     postoperatively and data is analyzed retrospectively. Vital parameters are monitored with~     ECG, blood pressure monitor and pulseoximetry.~      In the analysis the investigators will compare the results from the continuous monitoring to~     the measurements made by the nurses and registered in the EWS. The primary outcomes for the~     pilot study are the frequency of measurements resulting in a single parameter score of 3~     according to the EWS algorithm.~   "
35448|NCT03102606|"~     To assess Duration of Severe Neutropenia (DSN) in treatment Cycle 1 in patients with advanced~     or metastatic breast cancer, who have failed >/= 1 but < 5 prior lines of chemotherapy;~     advanced or metastatic non-small cell lung cancer (NSCLC) after failing platinum based~     therapy; or hormone refractory (androgen independent) metastatic prostate cancer treated with~     docetaxel (75 mg/m2) + plinabulin (RP3D) versus docetaxel (75 mg/m2) + pegfilgrastim (6 mg).~     Neutrophils count will be assessed at baseline; Pre dose during Cycle 1, Day 1, 2, 5, 6, 7,~     8, 9, 10, 15.~   "
35449|NCT03102593|"~     The purpose of the study is to determine safety, efficacy, tolerability and Pharmacokinetics~     of ARGX-113 in Patients with Primary Immune Thrombocytopenia.~   "
35450|NCT03102580|"~     Knee and hip osteoarthritis (OA) is the most common cause of disability in the U.S. and~     affects more than 60% of adults over 65 years. As the burden of knee and hip OA increases~     among aging adults, more patients are deciding to have joint replacement surgery. However, no~     clear guidelines exist for patients to determine if or when to undergo total joint~     replacement (TJR).~      The investigators plan to develop a web-based system that will provide individualized patient~     OA Care Plans that will help patients make informed decisions about how to treat their~     arthritis. The investigators will be using this system with patients to see if they find it~     useful.~      The investigators believe that the OA Care plan will improve the process and quality of OA~     treatment decisions and the quality of OA care.~   "
35451|NCT03102567|"~     This study is a Phase I, single-center, randomized, double-blind, placebo-controlled study to~     evaluate the effect of aging on safety, tolerability and PK of multiple oral doses of~     GLPG1205 in healthy male subjects.~      The study will comprise of 2 parts, a first part to investigate the effect of aging and a~     second part to investigate the effect of a loading dose.~   "
35452|NCT03102554|"~     This study seeks to identify genetic causes of conditions that affect the gonads and~     genitals, and to study the impact on families of receiving genetic results.~   "
35453|NCT03102541|"~     Acute kidney injury (AKI) occurs in approximately one-third of patients undergoing cardiac~     surgery (CS), and represents one of the most significant negative predictors of patient~     outcome in this population. In the healthy adult, a high protein meal is known to enhance~     glomerular filtration rate and is mediated by an increase in renal blood flow. The~     investigators hypothesized that preoperative oral protein load may precondition the kidneys~     for upcoming insults.~   "
35454|NCT03102528|"~     Acute kidney injury (AKI) occurs in approximately one-third of patients undergoing cardiac~     surgery (CS), and represents one of the most significant negative predictors of patient~     outcome in this population. The investigators sought to examine the prevalence of AKI, renal~     recovery and development of de-novo chronic kidney disease in all patients undergoing cardiac~     surgery at San Bortolo Hospital, Italy 2014-2015.~   "
35455|NCT03102515|"~     Analgesia following surgery associates different intra-venous or oral analgesic drugs and~     sometimes opioids. To reduce opioid consumption, loco-regional anaesthesia might be~     administered as a complement. In the specific context of caesarean sections, pain control is~     mandatory to enable the mother to take care of her offspring and shorten their hospital stay.~     This intervention is mainly performed under neuraxial anaesthesia (spinal or epidural),~     enabling the injection of morphine in the subdural or epidural space, as part of a multimodal~     analgesia regimen.~      Studies have evaluated continuous wound infiltration catheters (CIC) and ultrasound-guided~     (UGD) transabdominis plane (TAP) block, and both techniques and both techniques reduce~     postoperative morphine consumption. Recent studies have compared the two techniques and found~     conflicting results. Furthermore, they did not consider caesarean section performed under~     epidural analgesia, with a different neuraxial injection site, neither did they compared pain~     after postoperative day 2.~      Consequently, the aim of this study was to compare resting and standing pain up to~     postoperative day 3 after caesarean section performed under spinal or epidural anaesthesia~     and receiving either USG-TAP block or CIC. Baseline hypothesis was that the continuous~     infiltration provided a better analgesia at day 2.~   "
35456|NCT03102502|"~     The present study aimed to investigated the effect of Enhanced External Counterpulsation~     (EECP) on vascular hemodynamics and atherosclerosis, and the underlying shear stress related~     mechanisms~   "
35457|NCT03102489|"~     Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BP101 in Healthy~     Volunteers.~   "
35458|NCT03102476|"~     Type 1 Diabetes mellitus (T1D) is characterized by βcell destruction and a long life~     requirement of exogenous insulin. The bolus basal insulin regimen is a widely accepted~     therapy concept to treat hyperglycaemia in patients with T1D. This concept requires a very~     good knowledge of the individuals prandial and basal insulin requirements. However, insulin~     requirement depends on insulin absorption from the injection site and the individual's~     insulin sensitivity which relies on a number of effects including body composition,~     inflammatory processes and environmental factors. Climatic factors such as differences in air~     temperature could affect both, insulin absorption and insulin sensitivity as suggested by~     recent reports. For instance, it is reported that hot baths can accelerate the absorption of~     short acting but not of long acting insulin formulations from the subcutaneous depot. In~     addition, local warming of the injection site by a novel device (InsuPatch) results as well~     in an accelerated insulin action profile of short acting insulins. Moreover, Berglund et al.~     reported seasonal variations in insulin sensitivity in elderly men with increased insulin~     sensitivity during summer time.~      Although an effect of temperature on insulin absorption and action can be assumed and was~     subject to current clinical trials, there is only little knowledge on the effect of humidity~     and the cumulative effect of humidity and temperature on insulin pharmacodynamics and~     pharmacokinetics. For subjects with type 2 diabetes it was reported that accommodation to~     high temperatures and moist air of more than 75% is impaired compared to healthy subjects as~     determined by skin blood flow, temperature and moisture. Although it can be estimated that~     changes in blood flow due to hot and moist air affect the pharmacokinetics and~     pharmacodynamics of subcutaneous prandial insulins, to our knowledge no such study in~     subjects with T1D using the euglycaemic clamp technique was carried out yet. In order to~     assess the effect of temperature and humidity on insulin action, subjects with type 1~     diabetes will be administered a single dose of short acting insulin in an environmental~     chamber either at 15°C or a warm environment of 40°C with either a low or high humidity (10%~     vs. 90%). Moreover, an exploratory part of the trial will evaluate the measurement~     performance of several blood glucose meters under the experimental climatic situations.~   "
35459|NCT03102463|"~     This study aims to ascertain the potential of novel milk derived hydrolysates to improve~     glycaemic control to promote metabolic health. A comprehensive characterisation of the~     metabolic response to these milk derived hydrolysates will ascertain the effect of the~     hydrolysates in terms of insulin sensitivity. These hydrolysates have been shown to improve~     insulin resistance in cell and animal models. Therefore the investigators aim is to test~     their efficacy in overweight, insulin resistant individuals at risk of developing type 2~     diabetes.~   "
35460|NCT03102450|"~     In spite of many advantages of spermicides, there is no contraceptive efficacy study~     conducted with any spermicide in women aged over 40 years. That is why the aim of this study~     is to evaluate contraceptive efficacy, tolerance and acceptability of a spermicide with~     benzalkonium chloride (Pharmatex® cream) in women aged over 40 years.~   "
35461|NCT03102437|"~     This is a multicenter, prospective, single-arm Continued Access study of the Optimizer Smart~     System with CCM therapy.~   "
35462|NCT03102424|"~     The primary study objective is to demonstrate the use of Dragon Waves Resonant Home Care~     Electronic Nerve Stimulator (DW1330) is associated with improvement of blood glucose control,~     as measured by change of glycated hemoglobin (HbA1c). The second study objectives are to~     demonstrate that DW1330 is associated with the mechanism of glycemic control and inflammation~     pathways. The study is also aimed to investigate the safety of DW1330.~   "
35463|NCT03102411|"~     This cross-sectional survey study is to determine the prevalence of functional~     gastrointestinal (GI) disorders in the general population and to describe common triggers for~     food-related GI symptoms.~   "
35464|NCT03102398|"~     The purpose of this phase I/IIa study is to assess the safety and tolerability profile of~     TR399 in healthy volunteers and erectile dysfunction patients. This study will be conducted~     via a single-arm and open-label fashion.~   "
35465|NCT03102385|"~     This study examines the effects of a web-based motivational interview on 1) internal~     motivation to donate blood; 2) donor autonomy, competence and relatedness; and 3) donation~     intention and behavior. The study also evaluates whether group differences in donation~     intention and behavior are mediated by autonomy, competence, and relatedness, and in turn,~     internal motivation.~   "
35466|NCT03102372|"~     In this study, we aimed to examine the effect of whey protein supplementation given before~     night sleep on Fat Free Mass (FFM) preservation during a 4 wk period on Very Low Caloric Diet~     (VLCD).~      Half of the participants underwent a 4 week VLCD and walking program, while the other half~     underwent a 4 week VLCD, walking program and had an additional protein supplement before each~     night sleep.~   "
35468|NCT03102346|"~     Home-based CR (HBCR) was reported to improve the clinical outcomes of coronary artery disease~     (CAD) patients. There is no data published to investigate whether HBCR is also effective for~     Chinese CAD patients who have been revascularized.~      This trial was designed to investigate the safety and efficacy of CR program at home for~     Chinese patients who underwent PCI (Percutaneous Coronary Intervention) procedure. This is a~     multicenter, randomized, controlled and observational study.~   "
35469|NCT03102333|"~     In the case of the newlys developed PCA, the infusion rate is increased according to the~     patient's need for bolus button, so that the pain can be controlled more efficiently.~   "
35470|NCT03102320|"~     The key purpose of the main part of the study is to assess efficacy and safety of anetumab~     ravtansine as monotherapy or combination therapy for mesothelin expressing advanced solid~     tumors.~      The main purpose of the safety lead-in (dose-finding) part of the study is to determine the~     safety and tolerability of anetumab ravtansine in combination with cisplatin and in~     combination with gemcitabine, and to determine the MTD of anetumab ravtansine in combination~     with cisplatin for mesothelin expressing advanced cholangiocarcinoma and in combination with~     gemcitabine for mesothelin expressing advanced adenocarcinoma of the pancreas.~      Patients will receive anetumab ravtansine every three weeks in monotherapy for most~     indications. In cholangiocarinoma and adenocarinoma of the pancreas, 3-weekly anetumab~     ravtansine is administered in combination with cisplatin or gemcitabine respectively (both~     administered in a 2 week on / 1 week off schedule).~      Treatment will continue until disease progression or until another criterion for withdrawal~     is met. .Efficacy will be measured by evaluating the tumor's objective response rate.~     Radiological tumor assessments will be performed at defined time points until the patient's~     disease progresses.~      Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival~     or fresh biopsy tissue will also be collected for mesothelin expression testing and biomarker~     analyses.~   "
35471|NCT03102307|"~     A downstaging of axillary tumor-spread can be achieved in about 40% of the patients receiving~     neoadjuvant chemotherapy (NACT). The impact of NACT on loco-regional tumor control has not~     yet been sufficiently investigated. Moreover the pathologic nodal status after NACT is a~     strong prognostic marker. Therefore it is most desirable to identify the approximately 40% of~     patients with pathologic complete response of the axilla, that could be spared from a~     potentially non beneficial axillary lymph node dissection (ALND). Attempts to identify these~     patients via sentinel lymph node biopsy (SLNB) after NACT have failed to provide acceptable~     false negative rates (FNR). The new concept of targeted axillary dissection (TAD) following~     NACT has shown promising results. Still multiple information about the clinical adoption of~     this procedure into clinical practice are missing. The SenTa registry trial is designed to~     assess the clinical implementation of TAD into general practice.~   "
35472|NCT03102294|"~     Inspiratory muscle training for 8 weeks in patients with chronic thromboembolic pulmonary~     hypertension.~   "
35473|NCT03102281|"~     Bile duct stones is a common biliary tract disease, which is characterized by high morbidity~     and frequent recurrence. Endoscopic retrograde cholangiopancreatography (ERCP) is an~     effective therapy for common bile duct stones, and endoscopic sphincterotomy (EST) which~     associated with recurrent cholangiolithiasis often carried out on difficult intubation or~     extracting stones, probably due to enhanced reflux of intestinal contents that changes the~     microenvironment. Patients with cholangiolithiasis were consecutively recruited and their~     bile was collected intra-operatively for high-throughput experiments. Pyrosequencing of 16S~     ribosomal RNA gene was performed to characterize the microbiota in the bile and other body~     fluids. A liquid chromatography mass spectrometry-based method was used to profile bile~     composition. Clinical manifestation, microbiome, and bile composition were compared between~     patients with or without recurrent of bile duct stones. The aim of our study was to identify~     the impact of microbiomes on the recurrent of bile duct stones after ERCP+EST therapy.~   "
35474|NCT03102268|"~     Exosomes are part of extracellular vesicles(EVs), and can be secreted into the environment by~     many types of cells. It has been demonstrated that the content and function of exosomes~     depends on the originating cell and the conditions under which they are produced.Exosomes~     contain proteins,RNAs and lipid,which may transfer biological information and activities from~     donor cells to receptor cells. Non-coding RNAs are involved in many biological activities~     including tumor growth and metastasis.~      In this prospective translational study, preclinical and clinical phases have been designed.~     On the first step, the main goal is to characterize the ncRNAs of cholangiocarcinoma derived~     exosomes. This exosome biomarker may provide a useful diagnostic tool. As a second step, the~     study will evaluate the prognostic and predictive value of cholangiocarcinoma exosomes levels~     in plasma in a prospectively recruited cohort of cholangiocarcinoma patients before and after~     surgical resection.~   "
35475|NCT03102255|"~     The goal of this prospective randomized study is to compare the effect of nasal tip lifting~     during nasotracheal intubation.~      The question the investigators are trying to answer is: If the nasal tip is tilted, will the~     E-tube be more likely to enter the lower passage during nasal intubation?~   "
35476|NCT03102242|"~     Phase II trial of induction immunotherapy with atezolizumab for patients with unresectable~     stage IIIA and IIIB NSCLC eligible for chemoradiotherapy with curative intent.~   "
35477|NCT03102229|"~     This study will aim to demonstrate that implementation of a rapid, multidisciplinary~     supportive care program for patients receiving chemoradiotherapy who are deemed to be at high~     risk for hospitalization based on real-time pedometer data will reduce the rate of~     hospitalization during chemoradiotherapy or within four weeks of radiotherapy completion.~   "
35497|NCT03101969|"~     Patients tend to miss their scheduled appointments in chronic pain clinics for unknown~     reasons. This study will test the hypothesis in a prospective pragmatic trial that a human~     telephone call in the primary language of the patient, promising a clinical encounter in this~     language improves attendance at scheduled appointments in an academic inner city pain clinic.~   "
35498|NCT03101956|"~     The aim of this double blind, randomized, placebo-controlled clinical trial is to investigate~     the immediate effects of spinal manipulation on hip and knee muscle strength and pain-free~     deep squat range of motion in order to answer several conceptual and practical research~     questions~   "
35478|NCT03102216|"~     The 2015 Abbott Point-of-Care Great Minds Summit in Berlin presented novel research that~     showed the potential for upfront, point-of-care (POC) blood testing to improve waiting times,~     costs and patient flow in the Emergency Department (ED). POC testing has become a focus area~     for enquiry as EDs worldwide look for ways to cope with over-crowding and reduce waiting~     times.~      In South African EDs, the target time for patients to be seen is dictated by their triage~     category. Patients triaged Red (critical) should ideally be seen immediately, Orange within~     10 minutes, Yellow within 1 hour and Green within 4 hours of arrival. Whilst patients may~     initially be evaluated within the above time frames, there may be delays in their final~     disposition due to time lags in obtaining results from special tests and/or investigations.~     Traditionally, blood tests and other special investigations such as electrocardiograms (ECG)~     and radiological investigations (x-rays) take place after the doctor has evaluated the~     patient. Patients (and doctors) then have to wait for the results of these tests before a~     decision can be made regarding the patient's final disposition.~      Instead of sending blood specimens to the laboratory for analysis, POC blood testing refers~     to selected tests which can be performed in the ED and provide immediate on-site results and~     thus have the potential to expedite patient management decisions. Similarly, low dose x-ray~     (LODOX®) is the radiological equivalent of a POC blood test providing a full body x-ray~     within 19 seconds. LODOX has been evaluated in trauma patients previously but its application~     as a screening tool for non-trauma patients in the ED has not been properly explored thus~     far. Electrocardiograms (ECGs) are commonly used in clinical medicine as a POC test to~     evaluate the heart. Locally, Helen Joseph Hospital ED in Johannesburg has a constant influx~     of critically ill and injured patients 24 hours a day. The aim of this~     investigator-initiated, prospective, randomised control trial is to compare and assess the~     standard workflow pathway currently in use in the ED to a modified pathway that makes use of~     upfront, early POC tests (blood tests, ECG and/or LODOX) to see if the use of such has any~     significant effect on costs, waiting times and associated patient flow patterns in the ED.~   "
35479|NCT03102203|"~     To evaluate the efficacy of multi-modality magnetic resonance quantitative parameters in~     evaluating the treatment effects of high-grade gliomas, and to provide new biomarkers for the~     establishment of new diagnostic criteria for the identification of true and pseudoprogression~     of high-grade gliomas.~   "
35480|NCT03102190|"~     Verapamil is an L-type calcium channel blocker(CCB) which has been shown to reduce~     inflammation in a variety of tissues. Chronic rhinosinusitis with nasal polyps (CRSwNP) is~     characterized by eosinophilic inflammation as well as P-gp overexpression. A previous trial~     of oral Verapamil showed preliminary efficacy for the treatment of CRSwNP. The goal of this~     study is to evaluate the safety and efficacy of intranasal Verapamil in CRSwNP.~   "
35481|NCT03102177|"~     This study was a prospective, single-center, open-label, non-randomized, pharmacokinetic~     study using stable isotope carbon-13 labeled levothyroxine~   "
35482|NCT03102164|"~     The study will include 30 consecutive patients with acute heart failure (AHF). In 20 patients~     the investigators will perform cardiologic rehabilitation. In the remaining 10 patients only~     standard pharmacotherapy will be administered. The cardiologic rehabilitation will follow the~     protocol used routinely in patients with AHF admitted to the Centre for Heart~     Disease,Military Hospital in Wroclaw. This protocol includes gradually increasing level of~     physical exercise (e.g.: respiratory exercises, assisted, active dynamic, and relaxation~     exercises, as well as short-term isometric exercises and general exercises of very low~     intensity, short duration and properly adjusted recovery phase).~      The following tests will be conducted on the first and last day of hospitalization and 30~     days following the discharge:~      clinical evaluation (medical interview, routine physical examination, echocardiography,~     assessment of natriuretic peptides (NT-proBNP), basic laboratory tests with special emphasis~     on the inflammatory markers and renal and liver parameters); hemodynamic evaluation (i.e.~     non-invasive evaluation of cardiac output and systemic vascular resistance using of impedance~     cardiography); evaluation of biomarkers reflecting myocyte-damage (i.e. immunochemical~     measures of tissue-specific enzymatic isoforms, enabling to distinguish the markers of~     skeletal muscle damage vs. markers of myocardial injury - e.g. creatine kinase CK, its~     muscular isozyme CKMM, lactate dehydrogenase 5 LDH5, myoglobin, and carbonic anhydrase III,~     determined using test based on ELISA). On the first day of hospitalization, as well as on the~     first, third and last day of rehabilitation (the latter term corresponding to the last day of~     hospitalization as well) and also 30 days after the discharge, the following tests will be~     performed (both times: at rest and post-exercise): hemodynamic evaluation, the evaluation of~     skeletal muscle function (using surface electromyography (sEMG); maximum tonus of the muscles~     will be determined along with the level of muscular fatigability and its changes over time;~     the evaluation of muscle tissue perfusion (assessed on the basis of oxygenation level, with~     non-invasive, direct continuous recording of the perfusion in peripheral tissues by local~     tissue oximetry, measured by the near-infrared spectroscopy (NIRS). NIRS is based on the~     absorption of near-infrared waves by oxygenated and reduced haemoglobin. The levels of~     absorption reflect the degree of tissue oxygenation in a given area of microcirculation.~     Furthermore, a capillary gasometry (oxygen saturation and lactate concentration) will be~     determined). Moreover, two functional tests will be performed at the discharge and 30 days~     after the discharge: the 6-minute walk test and the 30-second chair stand test examining~     the strength endurance of the lower extremities (pertaining to repeated getting up from a~     chair over a period of 30 seconds).~   "
35483|NCT03102151|"~     The study examines the possible effect of a community campaign to decrease the duration of~     untreated psychosis in persons with their first episode of a psychotic disorder.~   "
35484|NCT03102138|"~     This is a safety follow-up study. Patients enrolled in B4711001 will be followed for a~     further 4 years with regular visits to assess safety.~   "
35485|NCT03102125|"~     The investigators will use cardiac MRI to measure the myocardial perfusion reserve and amount~     of myocardial edema and fibrosis in heart-transplant patients with nonspecific allograft~     dysfunction in contrast to those with normal graft function. The investigators hypothesize~     that patients with nonspecific allograft dysfunction will demonstrate decreased myocardial~     perfusion reserve, related to microvascular allograft vasculopathy, compared to those with~     normal graft function.~   "
35486|NCT03102112|"~     Malignant gliomas are the most common and deadly primary brain tumors in adults. The clinical~     outcome of patients with glioblastoma depends on key molecular genetic alteration.~     Specifically, Isocitrate Dehydrogenase Gene Mutation, an independent favorable prognostic~     factor, serve as diagnostic and prognostic markers of glioma. Thus, accurate grading of a~     glioma is fundamental in order to determine the treatment strategy. Amide proton transfer~     (APT) imaging is a noninvasive molecular MRI technique based on chemical exchange saturation~     transfer mechanism that detects endogenous mobile proteins and peptides in biological~     tissues. Preliminary studies have shown that APT-weighted (APTw) signal intensity could serve~     as a new imaging biomarker, by revealing significantly higher signal intensities in the~     high-grade gliomas compared with the low-grade gliomas. The purpose of this study was to~     investigate the value of amide proton transfer imaging (APT) in the noninvasive evaluation of~     isocitrate dehydrogenase (IDH) gene status in glioma.~   "
35487|NCT03102099|"~     To evaluate the application value of contrast-enhanced ultrasound in the diagnosis of thyroid~     nodules using fine needle aspiration.~   "
35525|NCT03101605|"~     An e-learning module to teach how to evaluate ears in children was recently designed. The aim~     of this study is to measure the impact of this e-learning module on the trainees' ability to~     appropriately diagnose ear infection in clinical setting.~   "
35556|NCT03101202|"~     Ventilator Associated Pneumonia (VAP) is associated with increased hospitalisation, increased~     health care cost and high morbidity and mortality. The incidence of VAP increases with~     duration of mechanical ventilation. There is limited data especially from India on the~     incidence of VAP and also the role of subglottic aspiration in its prevention. The aim of~     this study is to determine the role of subglottic suction in the incidence of VAP.~   "
35488|NCT03102086|"~     Dental calculus is a calcified deposits firmly attached to teeth and implants surfaces.~     Dental calculus is strongly associated with periodontitis and considered to have indirect~     role in the pathogenesis of periodontal diseases. Dental calculus composed primarily of~     calcium phosphate mineral salts originated in the saliva covered by unmineralized bacterial~     layer. Composition of calculus varies from person to person and influenced by numerous~     variables such as: age, gender systemic disease and ethnic background.~      Nephrolithiasis (kidney stones) are composed of insoluble salts of constituents of the~     forming urine. The most two frequent stone types are: Calcium oxalate (with a frequency of~     15% -35%) and Calcium phosphate (5% -20%). The prevalence of kidney stones varies with race,~     sex, and geographic location. In the United States for men, kidney stone rates vary between~     4%-9%, and for women, kidney stone rates range between 2%-4%.~      Previous studies dealt with the connection between sialolithiasis and nephrolithiasis were~     inconclusive. To the authors' best knowledge no studies were done to examine the associations~     between nephrolithiasis and dental calculus. Thus, the aim of this study is to compare the~     mineral composition of both dental calculus and nephrolithiasis and determine whether~     nephrolithiasis composition may be linked to the periodontal status.~   "
35489|NCT03102073|"~     Interventional, parallel groups, single center trial with a prospective design~   "
35490|NCT03102060|"~     This pilot clinical trial studies how well a gluten free diet works in preventing graft~     versus host disease in patients who are undergoing a donor stem cell transplant. Sometimes~     the transplanted cells from a donor can make an immune response against the body's normal~     cells (called graft versus host disease). A gluten free diet may decrease intestinal~     inflammation and graft versus host disease in patients who are undergoing a donor stem cell~     transplant.~   "
35491|NCT03102047|"~     This study is being done to look at the safety and response to the investigational drug~     durvalumab (MEDI4736) following chemo-radiation therapy for patients with MSS stage II to IV~     rectal cancer. Durvalumab recognizes specific proteins on the surface of cancer cells and~     triggers the immune system to destroy the cancer cells. The chemoRT portion of the treatment~     will be completed just before the course of durvalumab is initiated.~      In order to learn more about certain characteristics of rectal cancer tumors, this study~     includes special research tests using samples from diagnostic tumors, a tissue sample from~     tumors removed during surgery, fresh tumor samples from an area where the cancer has~     recurred, and blood samples.~   "
35492|NCT03102034|"~     The purpose of this study is to evaluate the safety, infectivity, and immunogenicity of a~     single dose of a recombinant live-attenuated respiratory syncytial virus (RSV) vaccine in~     RSV-seronegative infants and children 6 to 24 months of age.~      This study is a companion study to CIR 313.~   "
35493|NCT03102021|"~     The purpose of this study is to determine if the use of erythropoietin when used in high dose~     during acute kidney injury can decrease the number of days of kidney injury.~   "
35494|NCT03102008|"~     The purpose of this protocol is to employ single case analytic strategies, including a~     multiple baseline design and novel modeling techniques to identify changes in cross-cutting~     features of emotional disorders as well as emotional disorder symptoms during the~     implementation of The Unified Protocol for the Treatment of Emotional Disorders in~     Adolescents (UP-A). The first aim is to investigate relationships between the use of UP-A~     treatment components and changes in measures of cross-cutting features of emotional~     disorders. The second aim is to investigate when and how reductions in symptoms of emotional~     disorders and presenting problems (i.e., symptoms of anxiety and depression, severity of~     presenting problems) occur throughout treatment.~   "
35495|NCT03101995|"~     From the global burden of Cervical Cancer (CC), 85% occurs in developing countries,~     representing 12% of cancer in women. In Mexico CC ranks second in incidence and mortality~     among women. The National Institute of Cancer in Mexico (lNCAN) receives annually about 500~     patients with CC, 80% of which are diagnosed with locally advanced disease. Furthermore, 10~     to 20% of these present kidney deterioration. The main reason for kidney disease is ureteral~     obstruction, other causes include age and comorbidities, such as diabetes and hypertension.~     The standard treatment for locally advanced disease consists in concomitant~     chemo-radiotherapy based on cisplatin (QT-RT), followed by brachytherapy, with an absolute~     benefit of 10%. However, the use of cisplatin in patients with renal disease may be~     questionable, considering it is a nephrotoxic treatment. Given that renal dysfunction limits~     the standard treatment efficiency because of the widely known nephrotoxicity of cisplatin, in~     most Cancer Centers of our country, patients with renal dysfunction receive only radiation~     therapy, even though it has proven less effective than concomitant QT-RT, limiting~     disease-free and overall survival of these patients. Venook et al. used gemcitabine as a~     radiosensitizer in patients with cancer and renal dysfunction. Our group, has observed~     encouraging results using gemcitabine as an alternative to cisplatin in concomitant treatment~     with radiotherapy, in CC patients with renal insufficiency. 89% of patients had complete~     response and improvement in renal function, with an enhanced creatinine clearance after~     treatment. Therefore, it is necessary to explore the safety of gemcitabine as an alternative~     treatment for CC patients with locally advanced disease and renal deterioration. We propose~     this clinical trial to assess the safety of treatment with gemcitabine and specifically on~     renal function in patients with renal deterioration. It is important to take into~     consideration that CC in advanced stages produces pain, transvaginal fetid discharge and~     general discomfort. It also causes side effects secondary to renal failure such as nausea,~     vomiting, fatigue, anemia, among others. These effects have a significant impact on the~     quality of life of these patients. Cancer treatment and its side effects, besides the~     implications of a nephrostomy catheter or ileostomy bag, determine the deterioration in the~     quality of life of the patient, during and sometimes after treatment. Thus it is of utmost~     importance to evaluate the factors that could help improve the quality of life of patients~     and explore the factors that deteriorate it. This clinical trial aims to generate scientific~     evidence to help make the best decisions concerning the treatment of patients with cervical~     cancer and renal impairment, and the impact on their quality of life.~   "
35496|NCT03101982|"~     Hypothesis of the Study:~      Based on the presented results, the investigator hypothesises that HBO preserves neurons that~     are not irreversibly damaged (i.e. severed) during initial trauma, thus enabling regain of~     their function. The investigator predicts that HBO treatment protects and enhances motor~     function in initially paralysed regions, including improvement in function of the extremities~     as well as recovery of urinary bladder control and bowel function.~      Outline of the Proposed Study:~      Within a prospective proof of principle trial, a total of 100 patients will be included.~     Fifty patients will be recruited at the Division of Thoracic and Hyperbaric Surgery, Medical~     University of Graz. In parallel, 50 control patients will be included at the Department of~     Orthopaedics and Trauma, Paracelsus University Salzburg, Salzburger Landeskliniken (SALK),~     Austria. Thereby, all patients that are admitted at the Medical University of Graz can be~     treated and the enrolment of 50 patients into the treatment group can be implemented within~     the outlined time frame. The active recruitment period is planned for three years. Both HBO~     treated and control patients will undergo the same surgical and nonsurgical procedures. HBO~     treatment will be started within 24 hours after the injury. A total of 21 consecutive daily~     sessions will be applied, followed by routine rehabilitation programmes. By matching control~     and HBO-treated patients, an evaluation of the treatment effect of HBO is possible. The~     outcome will be evaluated by implementing the American Spinal Injury Association~     (ASIA)-scores and magnet resonance (MR) imaging. Additionally, inflammatory and regenerative~     blood markers will be analysed (neuroendocrine markers/neuro-transmitters: S100beta, Brain~     Derived Neurotrophic Growth Factor [BDNF], Glial Fibrillary Acidic Protein [GFAP], Reactive~     Oxygen Species (ROS), norepinephrine; array of pro- and anti-inflammatory cytokines and~     chemokines).~   "
35557|NCT03101189|"~     So far, ACT-541468 has been studied mainly in Caucasian subjects. The present study will~     bridge results obtained in Caucasian subjects to those in Japanese subjects.~   "
35499|NCT03101943|"~     This study aims to assess the impact of a brief home-visiting module, called Family Spirit~     Nurture (FSN), on American Indian (AI) parent feeding practices associated with increased~     risk for early childhood obesity, with a primary focus on delaying introduction of infants'~     Sugar Sweetened Beverage (SSB) (including soda, energy drinks, juice with added sugar and~     other drinks with added sugar) intake while teaching mothers complementary feeding and~     responsive parenting practices. The investigators will also assess how water insecurity may~     moderate parents' feeding of SSBs to young children. Finally, the investigators will explore~     whether maternal knowledge of oral health practices and/or reduction of infants' SSB intake~     influences early indicators of infant's oral health (i.e., infants' oral microbiome and~     plaque formation). Our evaluation will employ a randomized controlled design, in which the~     control condition receives a beneficial home-safety educational model and assistance in~     safety proofing their homes for small children. Assessments in both groups will occur at~     baseline (between 6 and 10 weeks postpartum) and 4 months, 6 months, 9 months and 12 months~     postpartum.~      Primary Aims:~      Aim 1: To determine the effectiveness of the brief (6 lessons) FSN home-visiting parent~     feeding practice module on reducing SSB initiation and frequency among infants between 3 and~     12 months of age. Hypothesis 1: Infants whose mothers receive FSN vs. controls will be less~     likely to introduce SSBs between 3 and 12 months of age.~      Aim 2: To determine the effectiveness of FSN to promote optimal complementary feeding and~     responsive parenting practices. Hypothesis 2: Mothers who receive FSN vs. controls will be~     more likely to practice recommended complementary feeding and responsive parenting practices~     between 3 and 12 months of age.~      Aim 3: To determine the impact of water insecurity on SSB consumption among infants between 3~     and 6 months of age. Hypothesis 2: Parents who report water insecurity vs. those who do not~     will be more likely to give infants SSBs between 3 and 6 months of age.~      Secondary Aims:~      Secondary Aim 1: To explore if provision of water to families reduces SSB intake among~     mothers and infants ages 6 to 9 months of age.~      Secondary Aim 2: To explore if infants in the FSN intervention have better oral health~     outcomes than control infants up to 12 months postpartum.~   "
35500|NCT03101930|"~     This project tests the principle hypothesis that stable glucagon like peptide-1 (GLP-1)~     analogues have specific GLP1R-dependent beneficial effects on vascular endothelial function,~     fibrinolysis and inflammation in obesity that exceed the benefits of weight loss, and that~     genetic or other individual factors that modulate GLP1R sensitivity can modify the effect of~     these analogues on cardiovascular risk.~   "
35501|NCT03101917|"~     The Microtable® Microstereotactic Frame and Drill Press and Associated Method for Cochlear~     Implantation consists of a patient-customized microstereotactic frame which targets the~     cochlea. The intended use of the device in this early feasibility study is to surgically~     access the cochlea, allowing placement of an intra-cochlear electrode array for cochlear~     implantation, thereby providing a less invasive surgical option than currently performed.~     Compared to traditional cochlear implantation (CI) surgery, the investigators hypothesize~     that the minimally invasive, image-guided approach may offer the following benefits: (1)~     shorter procedure time including shorter general anesthesia time, (2) less tissue removal~     potentially eliminating post-operative mastoid bone depression, decreased post-operative~     patient discomfort, and quicker wound healing, (3) better chance of preservation of taste~     secondary to preservation of the chorda tympani nerve, and (4) standardization of electrode~     placement potentially allowing more consistent placement within the scala tympani~     sub-compartment of the cochlea which has been shown to be associated with improved~     post-operative audiological performance. This early feasibility study will focus on the~     advantages of the new technology to the patient. Advantages to the healthcare delivery system~     will be examined during the pivotal study phase.~   "
35502|NCT03101904|"~     The study will aim to describe and evaluate the effect of chronic beetroot juice~     supplementation on acute mountain sickness symptoms and exercise in a hypoxic environment. It~     is hypothesized that beetroot supplementation will decrease acute mountain sickness and~     increase exercise performance.~   "
35503|NCT03101891|"~     This study offers eligible pregnant patients with a fetal diagnosis of congenital bilateral~     renal agenesis (CoBRA) serial amnioinfusions with normal saline. All eligible patients will~     be offered intervention but may also elect expectant management.~   "
35504|NCT03101878|"~     The purpose is to assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of~     IONIS AGT-LRx in up to 82 Healthy Volunteers~   "
35505|NCT03101865|"~     The suggested clinical trial is part of the KidsAP project funded by the European~     Commission's Horizon 2020 Framework Programme. The project evaluates the use of the~     Artificial Pancreas (or closed loop systems) in very young children with type 1 diabetes~     (T1D) aged 1 to 7 years. The suggested trial is a feasibility study to pilot the setup of a~     large-scale outcome trial and to address the specific needs of this population. The results~     of the pilot trial will feed into the design of the outcome study.~      In this study the investigators will compare closed loop insulin delivery using standard~     strength insulin to closed loop use with diluted insulin in very young children with T1D.~     Diluted insulin is a standard treatment approach for children with low insulin requirements.~     The investigators hypothesize that diluted insulin will lead to more stable glucose levels by~     reducing inaccuracies accentuated by delivery of minute amounts of insulin (frequently less~     than 0.1U/h [1μl/h with standard strength insulin] in small children compared to 1U/h in~     adults). These inaccuracies may result from pump plunger micro-jumps, tissues pressure~     build-up, and infusion set kinking. This study builds on previous and on-going studies of~     closed loop systems that have been performed in Cambridge in children and adolescents with~     T1D in clinical research facilities and in the home setting.~      The study adopts an open-label, multi-centre, multinational, randomised, two-period crossover~     design contrasting closed loop glucose control using diluted insulin and closed loop using~     standard insulin strength under free-living home conditions. The two intervention periods~     will last 3 weeks each with a 1 to 4 weeks washout period in between. The order of the two~     interventions will be random. A total of up to 30 young children aged 1 to 7 years with T1D~     on insulin pump therapy will be recruited through outpatient diabetes clinics at~     participating clinical centres to allow for 24 completed subjects available for assessment in~     each of the study arms.~      Prior to the use of study devices, participants and parents/guardians will receive~     appropriate training by the research team on the safe use of the study pump and continuous~     glucose monitoring system, and the hybrid closed loop insulin delivery system. Carers at~     nursery or school may also receive training by the study team if required. During the~     intervention periods, subjects and parents/guardians will use the closed loop system for 21~     days under free-living conditions in their home and nursery/school environment without remote~     monitoring or supervision by research staff.~      The primary outcome is time spent in target range between 3.9 and 10.0 mmol/l as recorded by~     CGM. Secondary outcomes are the time spent with glucose levels above and below target, as~     recorded by CGM, and other CGM-based metrics. Safety evaluation comprises the tabulation of~     severe hypoglycaemic episodes.~   "
35506|NCT03101852|"~     Severe (SAM, Body Mass Index-z < -3) and moderate (MAM, -3 ≤ BMI-z < -2) acute malnutrition,~     highly prevalent in HIV-infected children and adolescents, is an independent risk factor of~     death, even when antiretroviral treatment (ART) is initiated. The objectives of the SNAC'S~     study are to assess acceptability and effectiveness of outpatient nutritional rehabilitation,~     using ready-to-use food (RUF), elaborated in compliance with national and international~     recommendations and implemented in HIV-infected children and adolescents, under active~     follow-up in the 12 main pediatric HIV care sites in Senegal and presenting with SAM or MAM.~   "
35526|NCT03101592|"~     This is an unblinded cluster-randomized study to evaluate the effectiveness of two strategies~     for scripting/dispensing of antiretroviral therapy (ART) on retention, virologic suppression,~     and cost compared to the standard of care. The study will be conducted in Malawi and Zambia~     among approximately 8,200 HIV-1-infected adults (18 years or older) who are stable on ART.~     Clusters will be randomized to one of three study arms: (1) standard of care (SOC) ART~     scripting (varies by country, region, clinic, and/or provider), (2) three-month ART~     scripting, and (3) six-month ART scripting. 30 clusters will be selected for the study, 15 in~     Malawi and 15 in Zambia, and will be randomized to a study arm.~   "
35507|NCT03101839|"~     A Phase I, open-label, multicentre, dose-escalation study to investigate the safety,~     pharmacokinetics and maximum tolerated dose (MTD) of AZD4785 in patients with advanced solid~     tumours where KRAS may be an important driver of tumour survival.~      Part A: Dose escalation in patients with solid tumours to evaluate safety, pharmacokinetics~     and maximum tolerated dose (MTD). Once the maximum tolerated dose (MTD) is established, a~     dose expansion cohort may be included in Part A, with up to an additional 6 patients to~     further explore the PK, safety, tolerability, and preliminary anti-tumour activity of the~     AZD4785 MTD for confirmation of the recommended phase 2 dose (RP2D).~      Part B: Expansion cohort at the selected dose in patients with non-small cell lung cancer~     (NSCLC) to evaluate PK parameters, safety, tolerability, and preliminary anti-tumour activity~     of the AZD4785 RP2D as monotherapy in patients with NSCLC. Approximately 20 patients with~     NSCLC (Two groups of approximately 10 patients each) with NSCLC will be enrolled to Part B.~     Group 1 patients will have an option to provide tumour biopsies and Group 2 will be required~     (mandatory) to provide paired tumour biopsies. Overall up to 12 patients in Group 2Part B~     patients will be required (mandatory) to may provide paired tumour biopsies. A third group of~     up to 20 patients with other tumour types and/or a potential different schedule may be added~     based on the results seen in Parts A and B and any other emerging data and may also provide~     biopsies.~   "
35508|NCT03101826|"~     The Polyvagal Theory focuses on how function and structure changed in the vertebrate~     autonomic nervous system during evolution. The theory is named for the vagus, a major cranial~     nerve that regulates bodily state. As a function of evolution, humans and other mammals have~     a new vagal pathway that links the regulation of bodily state to the control of the muscles~     of the face and head including the middle ear muscles. These pathways regulating body state,~     facial gesture, listening (i.e., middle ear muscles), and vocal communication collectively~     function as a Social Engagement System (SES). Because the Social Engagement System is an~     integrated system, interventions influencing one component of this system (e.g., middle ear~     muscles) may impact on the other components.~      Individuals with Prader-Willi Syndrome (PWS) exhibit many behaviors that are consistent with~     a compromised Social Engagement System. Atypical function of the Social Engagement System~     results in problems associated with state regulation (e.g., impulsivity, tantrums, and~     difficulty with change in routine), ingestion (e.g., difficulties in sucking at birth,~     hyperphagia), coordination of suck/swallow/breathe, intonation of vocalizations, auditory~     processing and hypersensitivity, and socialization. We propose to confirm that several~     features of the behavioral phenotype of PWS may be explained within the context of a~     dysfunctional SES (Specific Aim I), which may be partially rehabilitated via an intervention~     designed as a 'neural exercise' of the SES (Specific Aim II).~      Specific Aims:~      Aim I: To demonstrate that children with PWS have atypical regulation of the SES. We~     hypothesize these effects will be manifested by dampened vagal regulation of the heart (low~     parasympathetic tone); poor middle ear muscle regulation resulting in auditory~     hypersensitivities and poor auditory processing; lack of voice intonation (prosody), and~     difficulties in accurately detecting the emotions of others.~      Aim II: To demonstrate the effectiveness of the Listening Project Protocol (LPP) in~     decreasing the atypical features of the SES in adolescents with PWS. We hypothesize that~     individuals who complete the LPP will have improved vagal regulation of the heart, improved~     middle ear muscle regulation, increased voice intonation and improved ability to accurately~     detect the emotions of others.~   "
35509|NCT03101813|"~     Doctors and other medical scientists want learn about the biology of DIPG and to develop~     better ways to diagnose and treat patients with DIPG. To do this, they need more information~     about the characteristics of DIPG tumors. Therefore, they want to establish a central~     location for clinical information and tumor tissue collected from DIPG patients.~      The purposes of this study are:~        -  To enroll patients diagnosed with DIPG in the International DIPG Registry and~          Repository.~        -  To provide a central location for clinical information, scans, and tissue samples from~          patients with DIPG enrolled in the registry.~        -  To collect tissue samples in order to study how DIPG works on the molecular level.~          Researchers may use the tissue samples to study molecules such as proteins and DNA.~          Proteins are needed for the body to function properly and DNA is the molecule that~          carries our genetic information. Other researchers will be able to use the stored~          samples in the future to learn more about DIPG. The information researchers get from the~          research studies will be kept in the registry along with the clinical information.~        -  To help DIPG investigators around the world to work together to make more consistent~          diagnosis and better design of future research studies. We hope this will lead to better~          treatments for DIPG in the future.~   "
35510|NCT03101800|"~     Azathioprine is considered first line immunomodulatory therapy for patients with ulcerative~     colitis. Up to 50% are treatment failures or experience adverse events leading to treatment~     withdrawal. Recent evidence suggests that the combination of allopurinol and low dose~     azathioprine increases the proportion of treatment responders and reduce the risk of adverse~     events.~      Objectives: To evaluate the beneficial and harmful effects of low dose azathioprine and~     allopurinol versus standard azathioprine monotherapy in patients with ulcerative colitis.~   "
35511|NCT03101787|"~     Despite adequate conventional cardiopulmonary resuscitation (CCPR) and attempted~     defibrillation, a considerable number of patients in cardiac arrest fail to achieve sustained~     return of spontaneous circulation. The INCEPTION trial is a multicenter, randomized~     controlled trial that will explore extracorporeal cardiopulmonary resuscitation (ECPR) in~     patients in refractory out-of-hospital cardiac arrest (OHCA) presenting with ventricular~     fibrillation or tachycardia. It aims to determine the effect on survival and neurological~     outcome. Additionally, it will evaluate the feasibility and cost-effectiveness of ECPR.~   "
35512|NCT03101774|"~     Comparable RCTs of clinical therapeutic effects using respiratory physiology-oriented IMT~     device in different operation principle in COPD are so far lacking. Therefore the~     investigators perform an adequately powered RCT on the effects of two IMT device application~     as an pulmonary physical therapy in patients with COPD with inspiratory muscle weakness.~   "
35513|NCT03101761|"~     Chilblains are cutaneous lesions affecting extremities (foot and fingers) with erythemic~     papules, evolving by painful relapse due to cold and sudden reheating.~      This pathology is currently poorly understood while it's frequent.~      The aim of the study is to evaluate all the characteristics of this pathology by reporting~     clinical and biological data of patient consulting for chilblains; and the other point is to~     assess the evolution of these patients.~   "
35558|NCT03101176|"~     Rationale: The current limitations in prostate cancer diagnostics, due to lack of accuracy of~     the available techniques, lead to over- and undertreatment for a significant fraction of~     patients with prostate cancer. Multiparametric ultrasound (mpUS), a new imaging modality~     combining different ultrasound parameters, heralds the potential for an accurate~     imaging-based diagnostic approach accessible to the community at large but formal validation~     of mpUS against final pathology results are still lacking.~      Objective: To validate mpUS as imaging modality for detection and localization of prostate~     cancer by direct correlation with histopathology of radical prostatectomy specimens~   "
35514|NCT03101748|"~     The goal of this clinical research study is to learn if adding neratinib to either taxol~     (paclitaxel) or to the combination of pertuzumab, trastuzumab, and paclitaxel can help to~     control metastatic or locally advanced breast cancer when given before other standard~     chemotherapy (doxorubicin and/or cyclophosphamide) and surgery. Researchers also want to find~     the highest tolerable dose of neratinib that can be used in these study drug combinations.~     The safety of these drug combinations will also be studied.~      This is an investigational study. Pertuzumab and trastuzumab are FDA approved and~     commercially available for the treatment of HER2-positive breast cancer. Paclitaxel,~     doxorubicin, and cyclophosphamide are FDA approved and commercially available for the~     treatment of breast cancer. Neratinib is FDA approved and commercially available. The drug~     combinations are investigational and are currently being used for research purposes only.~      The study doctor can describe how the study drugs are designed to work.~      Up to 99 participants will be enrolled in this study. All will take part at MD Anderson.~   "
35515|NCT03101735|"~     This is a non interventional, multicenter clinical trial, in adult patients receiving~     Tecfidera per approved SmPC and routine clinical practice. The primary objective of this~     study is to evaluate the total societal costs to the healthcare system related to the use of~     Tecfidera in RRMS patients. The study will capture data in a simple matter that can be easily~     interpreted providing an advantage in a country where efforts in the market access arena are~     in their infancy. For the aforementioned reasons, the proposed study may prove quite valuable~     in supporting DMF as a cost‐effective therapy, valuable not only for patients but for the~     public health care system as well, providing all the necessary information for the evaluation~     that need to be examined regarding the positive reimbursement list and future decisions.~   "
35516|NCT03101722|"~     To investigate the effects of hearing aid, huperzine A and combination of hearing aid and~     huperzine A on tinnitus suppression, hearing and cognitive function protection in patients~     with presbycusis~   "
35517|NCT03101709|"~     This is a clinical study to observe the safety and feasibility of chimeric antigen receptor~     19 (CART-19) cells in relapsed and refractory patients with CD19+ B cell lymphoma.~   "
35518|NCT03101696|"~     The gold standard to induce coronary hyperemia for measurement of fractional flow reserve~     (FFR), coronary flow reserve (CFR) and index of microcirculatory resistance (IMR) is~     adenosine, but it exerts several side effects due to its unspecific action on adenosine~     receptors. The specific A2a-receptor agonist, regadenoson, has been shown to dilate coronary~     arteries and enables FFR measurements. The aim of the study was to evaluate whether~     simultaneous measurement of FFR, CFR and IMR is feasible, safe and effective within~     regadenoson-induced hyperemia.~   "
35519|NCT03101683|"~     STUDY DESCRIPTION: This is a single-arm study to assess the feasibility, toxicity and~     cosmetic outcome of partial radiotherapy of the chest wall in breast cancer patients at~     increased risk of local relapse submitted to nipple-areola complex (NAC) sparing mastectomy~     and immediate implant-based reconstruction Inclusion criteria~      Histologically confirmed diagnosis of in situ ductal carcinoma (pTis) or invasive breast~     carcinoma (pT1 and pT2), submitted to NAC sparing mastectomy with prosthetic-based breast~     reconstruction (expander or prosthesis) and:~      Group A)~      Negative sentinel node dissection or axillary clearance (pN0) and all the following risk~     factors:~      Close (less than 1 mm) or positive (ink on tumor margin) surgical margin in a single breast~     quadrant Tumor diameter >2 cm Age ≤50 years Group B)~      Positive sentinel dissection (pN1a) followed by axillary clearance (or primary axillary~     clearance) with only 1 positive node and any of the following risk factors:~      Close (less than 1 mm) or positive (ink on tumor margin) surgical margin in a single breast~     quadrant Age ≤50 years Tumor diameter >2 cm Grade 3 histology Lymphovascular invasion HER-2~     overexpression/amplification Triple negativity Treatment - Radioterapy The tumor bed is~     defined by the area at risk (skin and the pectoralis muscles) delineated by surgical clips~     and 3D-MRI reconstruction for a precise localization of the tumor excised. The clinical~     target volume (CTV) is defined as the tumor bed with a 1.5 cm margin limited by skin contour.~      A dose of 40 Gy is delivered in 16 fractions (2.5 Gy per fraction). For conventional~     post-mastectomy radiotherapy this moderately hypofractionated schedule is considered feasible~     and safe (31). Even more so, this schedule should be feasible and safe for a smaller~     irradiated volume as in the current protocol. Regional nodal irradiation is not considered at~     our Institution for patients fulfilling the entry criteria of the protocol.~      OUTCOME MEASURES Primary To assess feasibility of PCWRT via VMAT-IGRT linac-based or helical~     Tomotherapy To assess the safety of PCWRT via VMAT-IGRT linac-based or helical Tomotherapy To~     assess the surgical complication of implant-based breast reconstruction after PCWRT Secondary~     To assess the cosmetic outcome of implant-based breast reconstruction after PCWRT To assess~     patients' satisfaction of implant-based breast reconstruction after PCWRT~   "
35520|NCT03101670|"~     This is a multicenter, Phase 2, double-blind, placebo-controlled study in subjects with~     moderately to severely active Psoriatic Arthritis (PsA) who have an inadequate response or~     are intolerant to conventional disease-modifying therapy. A total of approximately 124~     subjects will be randomized to one of 2 treatment arms in a 1:1 ratio: oral filgotinib~     tablets q.d. or matching placebo tablets q.d. The Screening visit will occur within 28 days~     before study drug administration. At Day 1 (Baseline), eligible subjects will be randomized~     to treatment for a duration of 16 weeks. The study is concluded with a Follow-up period~     lasting until 4 weeks after the last dose. Consequently, each subject will stay in the study~     for a maximum of 24 weeks (from Screening visit to Follow-up visit).~   "
35521|NCT03101657|"~     The increase in psychological violence in our society, but also and above all the search for~     the best possible reparation for this violence, leads increasingly to questioning the~     evaluation of psychotraumatisms. In practice, there is no consensus as to the method of~     assessing psychological repercussions and determining ITI. This topic concerns any physician~   "
35522|NCT03101644|"~     This study will assess and characterize the variability observed in the response to darunavir~     therapy, an antiretroviral medication used against the Human Immunodeficiency Virus (HIV).~     More specifically, it aims to quantify variations in the drug's blood concentrations and~     determine the sources of such variability, both genetic and non-genetic. In light of this~     information, current dosage guidelines will then be reviewed.~   "
35523|NCT03101631|"~     The Comprehensive Geriatric Assessment (CGA) is, still today, barely established in the~     standard practice. Although the different scientific societies recommend a CGA in elderly~     population affected with cancer at first visit, the evidence regarding its transcendence is~     limited. On the other hand, the components of this evaluation and the translation of their~     findings in changes in the clinical practice are not stablished. This project intends to~     implement a CGA in a group of patients to compare this group with an historical cohort that~     reflects the standard practice, to evaluate the differences between both approaches. The~     study also evaluate the feasibility and utility of this CGA. All these questions aims to~     support the hypothesis that CGA impacts on the cancer treatment for elderly population~     affected with cancer.~   "
35524|NCT03101618|"~     We investigated the prevalence of animal allergy and sensitization to animal allergen among~     participants in international symposium of Korean association for laboratory science~     (laboratory animal researchers) and companion animal exhibition (pet owner and pet-related~     industry workers).~   "
35527|NCT03101579|"~     It has been proved that intrathecal chemotherapy is the main treatment strategy for~     leptomeningeal metastases. At present, the commonly used drugs for intrathecal chemotherapy~     include methotrexate, cytarabine, and liposomal cytarabine. In recent decades, no new~     effective drugs have been discovered for intrathecal chemotherapy. The recurrence of~     leptomeningeal metastases is inevitable even after aggressive treatment. There is no~     effective treatment for recurrent leptomeningeal metastases after comprehensive treatment~     which includes intrathecal methotrexate and/or cytarabine, central nervous system radiation~     therapy, systemic chemotherapy as well as tyrosine-kinase inhibitor drugs. The quality of~     life is extremely poor, and the patients always die in short time. Pemetrexed is a newer~     multitargeted antifolate which has shown activity in various tumors. It has higher~     effectiveness and safety, which has been used as the first-line treatment of non-small cell~     lung cancer. In animal studies, pemetrexed was demonstrated to suppress tumor growth~     completely in mice with two types of transplanted human colon xenografts resistant to~     methotrexate. Therefore, the purpose of the study is to evaluate the safety and feasibility~     of intrathecal pemetrexed in patients with recurrent leptomeningeal metastases from non-small~     cell lung cancer.~   "
35528|NCT03101566|"~     The purpose of this trial is to evaluate the effect of investigational drug nivolumab in~     combination with either gemcitabine/cisplatin chemotherapy, or in combination with another~     investigational agent ipilimumab in patients with advanced unresectable biliary tract cancer.~      Gemcitabine/cisplatin is the standard of care treatment for biliary tract cancer.~      Nivolumab and ipilimumab are types of immunotherapy. Immunotherapy works by encouraging the~     body's own immune system to attack the cancer cells. Nivolumab (Opdivo) is FDA approved for~     the treatment of several cancers including metastatic melanoma, advanced lung, kidney, head &~     neck and bladder cancer. The combination of nivolumab and ipilimumab (Yervoy) is FDA approved~     for metastatic melanoma.~   "
35529|NCT03101553|"~     The present study aims to examine the feasibility of a computerized treatment for social~     anxiety disorder. To evaluate the efficacy of the IBM protocol the investigators have~     developed in reducing evaluation and social threat biases, they will conduct a two-arm~     randomized controlled trial. Individuals with a diagnosis of social anxiety disorder (N = 50)~     will be randomized to one of two conditions: 1) IBM or 2) progressive muscle relaxation. Each~     condition will consist of eight 25 minute treatment sessions. Participants will complete two~     sessions per week for four weeks and will be administered assessments at pre-treatment, one~     week post-treatment and at 3-month follow-up. It is hypothesized that: 1) IBM will lead to~     greater reductions in social anxiety symptoms than the PMR condition; 2) IBM will lead to~     greater reductions in depression and anxiety than the PMR condition; 3) IBM will lead to~     greater reductions in threat interpretations and greater increases in benign interpretations~     than the PMR condition; 4) The effects of condition on social anxiety symptoms will be~     mediated by changes in social anxiety-related interpretation bias; and 5) The effects of~     condition will be maintained at the 3-month follow-up assessment.~   "
35530|NCT03101540|"~     For a number of reasons women with major depressive disorder often discontinue conventional~     antidepressants when they become pregnant and prefer not to take them when depressive illness~     develops in the course of pregnancy. There is now considerable evidence that the~     administration of the omega-3 polyunsaturated fatty acid, eicosapentaenoic acid (EPA), as~     monotherapy has antidepressant effects. If it could be clearly established as effective such~     an approach would offer a valuable alternative for woman who are at risk for, or who develop,~     depressive disorder during pregnancy. Strongly positive placebo-controlled trials of EPA~     supplementation, though, co-exist with entirely negative ones. No clear reasons for these~     discrepancies have emerged but one possibility is that the samples studied have differed in~     the proportion of individuals likely to benefit from EPA supplementation. As there has been~     no effort to identify such individuals we propose to explore two groups of measures, both~     relevant to EPA's likely mechanisms of action, as potential tools for identifying individuals~     likely to benefit this treatment. Hypothesis: Among women who experience major depressive~     episodes during their first two trimesters of pregnancy, baseline measures of cytokine~     activity and erythrocyte PUFA concentrations will be associated, in an additive or~     interactive fashion, with subsequent improvement in depressive symptoms among women taking~     omega-3 PUFA supplementation.~   "
35531|NCT03101527|"~     The purpose of this study is to determine if omega-3 polyunsaturated fatty acids as a~     monotherapy have antidepressant effects during pregnancy. It will also provide pilot data~     pertaining to relationships between apparent response to omega-3 monotherapy and both plasma~     cytokine and erythrocyte essential fatty acid concentrations.~   "
35532|NCT03101514|"~     About 89%-100% patients with head and neck malignant tumors have radiation mucositis during~     their radiotherapy. Until now, there is no effective method to prevent mucositis. Steroid~     hormone, pain-relief, anti-inflammatory and other symptom-relief treatments usually are used~     after the emergence of mucositis. Coixenol triglyceride is an ester extract of Coix Seed. Its~     trade name is Kanglaite Injection, which has been approved in China and Russia. Kanglaite has~     anti-tumor effect and reduce treatment toxicity of tumor. Kanglaite could also improve the~     quality of life of patients and mitigate the condition of the cachexia. In china, two studies~     evaluating treatment of Kanglaite to nasopharyngeal cancer, found that Kanglaite can reduce~     radiotherapy mucositis. So far, Kanglaite on the prevention and treatment of radiation~     mucositis of the head and neck malignant tumor is still lack of strong clinical trial~     evidence. This is a phase II, single center, one arm study with subject to evaluate the acute~     radiation mucositis, nutritional status, and quality of life on the course of radiotherapy of~     head and neck cancer.~   "
35533|NCT03101501|"~     The clinical objective of this study is to evaluate the Raindrop® Near Vision Inlay for the~     improvement of near vision in presbyopic or pseudophakic patients treated with low dose~     Mitomycin C immediately following femtosecond flap creation.~   "
35534|NCT03101488|"~     This dose escalation and dose expansion study is to evaluate and characterize the~     tolerability and safety profile of single agent KN035 in Chinese adult subjects with~     unresectable advanced carcinoma.~   "
35620|NCT03100357|"~     The pronounced effect of goiter on the esophagus needs further exploration, as the mechanisms~     by which goiter leads to swallowing difficulties are unknown. By investigating esophageal~     motility using high resolution esophageal manometry before and after thyroidectomy we seek to~     examine the impact of the goiter mass on the esophagus and swallowing with six months~     follow-up.~   "
35535|NCT03101475|"~     This is a single-arm, open-label, multi-center early phase II study. This proof of concept~     study will investigate whether the combined use of local tumor ablation/radiation plus~     immunomodulating drugs may induce a significant immune response in patient with incurable~     liver metastases from colorectal cancer (CRC) (+/- limited extrahepatic disease) being stable~     or in partial remission after completion of 4-6 months first line systemic therapy.~      The primary objective of the study is to show an overall response rate of lesions not treated~     by ablation/radiotherapy including the extrahepatic lesions (according to iRECIST criteria)~     higher than 10%. With the continuation of first line systemic treatment, no further responses~     are expected.~      Secondary objectives are:~        -  To establish the feasibility and safety of the combined treatment modalities;~        -  To study the impact of the local technique (RFA/Radiotherapy) on the results;~        -  To investigate biomarkers to predict response to the combined treatment~   "
35536|NCT03101462|"~     This randomized, open-label, single-site study at Saint Louis University will enroll~     approximately 40 subjects who are healthy, 18 to 49 years old. Subjects will be randomized in~     a 1:1 fashion to receive either licensed trivalent FluMist containing (2010-2011 season~     appropriate), or licensed inactivated trivalent influenza vaccine (2010-2011 season~     appropriate) so that approximately 20 subjects will be randomized to receive LAIV, and 20~     will receive TIV.~   "
35537|NCT03101449|"~     This research aims to evaluate the effects of vocal conditioning through two semioccluded~     vocal tract exercises (SOVTE) in choir singers.~   "
35538|NCT03101436|"~     In this study, the investigators will evaluate the prebiotic effect of a moderate intake of~     extra virgin olive oil or red wine on the modulation of gut microbiota composition and the~     improvement of cardiometabolic factors in obese and lean adults subjects.~   "
35539|NCT03101423|"~     Hematopoietic stem cell transplantation is currently the only way to cure thalassemia, one of~     its main obstacles is the rejection after transplantation, chimerism continued to decline,~     which eventually lead to transplant failure. chimerism is a key indicator of the succession~     of immune response, which is a key indicator for predicting the failure of hematopoietic stem~     cell transplantation and provides an important basis for early detection of rejection.~     Transplantation of continuous chimerism can detect early unstable chimeras and rejection.The~     chimerism rates after transplantation were continuously monitored using fluorescence labeled~     multiplex PCR amplification of short tandem repeats (STR-PCR)~      ,and then follow our STR different rates for early interventional therapy to prevent further~     reduction in chimerism leading to lead to graft failure.~   "
35540|NCT03101410|"~     This clinical project aims to study the relationship between gluten consumption and its~     impact on digestive comfort, quality of life and performance of non-celiac athletes~     practicing an intensive physical activity..~   "
35541|NCT03101397|"~     Diffuse Parenchymal Lung Disease(DPLD) is a chronic progressive fibrosis lung disease that~     with a highly variable clinical process.Krebs von den Lungen-6 (KL-6) is a~     high-molecular-weight glycoprotein, classified as human MUC1 mucin, that is produced mainly~     by regenerating type II pneumocytes.Serum levels of KL-6 have been shown to be elevated in~     patients with DPLD and could predict progress, but unaware of the differential threshold. The~     objective of this study was to perspectively and sequentially monitor serum KL-6 levels in~     patients with different DPLD,then analyze its clinical value and find the differential~     threshold.~   "
35542|NCT03101384|"~     Diagnostic errors have been reported frequently in patient with pulmonary embolism since~     symptoms are not specific. However, there is only scarce evidence that the delay associated~     with diagnostic errors may impact patient prognosis. The aim of this study is to determine~     the frequency of diagnostic errors and if they are associated with more severe pulmonary~     embolism in term of initial presentation and complications.~   "
35543|NCT03101371|"~     Urinary Tract Infection (UTI) complications following catheter use in surgical patients~     remains high. Using an aseptic protocol has been shown to drastically reduce UTI incidence by~     50%. Reducing UTIs will prevent extended hospital stays, readmission, and antibiotic use~     associated with this complication and improve cost-effectiveness of care. The investigators~     hypothesize that they can reduce the incidence of UTIs after catheter placement with the~     implementation of a Quality Improvement (QI) protocol to prevent excess exposure to the~     environment exposure of the catheter before, during and after insertion.~   "
35544|NCT03101358|"~     This study evaluates a topical nanoparticle paclitaxel ointment (SOR007) for the treatment of~     cutaneous metastases from non-melanoma cancer in adults. Three concentrations of SOR007 will~     be evaluated in dose-rising cohorts of three. An expanded cohort will treat additional~     subjects at the maximum tolerated dose.~   "
35545|NCT03101345|"~     The objective of this research project is to determine the impact on brain HEP metabolites~     and fluxes of an oral consumption of a commercially available nutrition product (Peptamen®~     1.5 vanilla) in healthy volunteers.~      Therefore, we intend to perform 31P-MRS before and after oral intake of the nutrition~     product.~   "
35555|NCT03101215|"~     Phosphorus is a widely used sport supplement. Most athletes who use it follow a phosphorus~     loading approach which consists of a weeklong phosphorus intake of 3-4 gr per day for optimal~     effect. The ergogenic potential of phosphorus is believed to be related to several factors~     including its ability to a) enhance ATP availability for energy expenditure and b) increase~     plasma content of 2.3-DPG (2.3-disphosphoglycerate) that is known to reduce oxygen affinity~     to hemoglobin and consequently enhances its release in the exercising tissue. Additionally,~     phosphorus was reported to increase peripheral glucose uptake and thus glycogenesis and~     glycogen storage. We have recently observed that the peripheral glucose uptake was stimulated~     by co-ingestion of phosphorus with meal, while pre ingestion failed to do so. Thus it is~     reasonable to postulate that phosphorus co-ingestion with meal improves ergogenesis through~     enhancing glycogen storage. The aim of this experiment is to investigate whether acute~     phosphate supplementation of a glucose load is responsible for the performance enhancement.~     This may help in explaining the controversies surrounding the impact of phosphorus on~     performance. A cross over study will be conducted on water polo players. In brief, overnight~     fasted subjects, will be given glucose load with or without phosphorus. Three hours later~     their performance will be measured using an ergometer cycling machine.~   "
35621|NCT03100344|"~     The aim of the study is to assess the efficacy of several subcutaneous doses of nemolizumab~     in moderate-to-severe AD subjects with severe pruritus receiving TCS, who were not adequately~     controlled with topical treatments.~   "
35546|NCT03101332|"~     Panic disorder with agoraphobia (PDA) is associated with considerable personal distress,~     functional disability and societal costs. A large number of studies have shown that Cognitive~     Behavior Therapy (CBT) is a highly effective treatment for PDA. However, the CBT-protocols~     proven to be most effective involves repeated exposure to the particular environments the~     agoraphobic patient fears such as trains, tunnels, lifts and shops. This cause great~     practical problems for health care services as such therapeutic efforts involves spending~     considerable time outside the clinic. For primary care services this is particularly~     challenging due to the large number of patients expected to be seen. Normally clinicians meet~     up to 7 patients daily which makes it almost practically impossible to offer 2-hour sessions,~     which is necessary to carry out the relevant exposure tasks. Hence, the treatment proven to~     be most effective, which primary care services are commissioned to deliver, is too~     comprehensive and time consuming to be applied in real practice.~      The investigators believe that a possible solution to the above problem is to provide~     evidence-based CBT but with the exposure components carried out through Virtual Reality (VR)~     rather than in vivo. Some research has already been done with virtual reality and exposure~     therapy for anxiety disorders with promising results. The aim of this pilot study is to treat~     patients with agoraphobia with or with a history of panic disorder with a standardized~     exposure-based CBT-protocol through VR. The virtual environments that are used for the study~     are live sequences filmed in 360°. The investigators hypothesize that CBT with VR will be~     effective and lead to improvements on measures of panic disorder and agoraphobia.~   "
35547|NCT03101319|"~     The treatment of schizophrenia is challenging as the existing medications improve only the~     positive symptoms with the limited benefit on cognitive and negative symptoms which have a~     large bearing on the functional outcome. Recent research has suggested the association of low~     level of vitamin D with schizophrenia but studies are few and marred by mixed results. Thus,~     we propose to evaluate the effect of weekly vitamin D3 supplementation in patients with~     first-episode schizophrenia through a randomised doubled blind placebo controlled~     design.Fifty-six participants of either sex (19 - 50 years) with schizophrenia having vitamin~     D insufficiency/deficiency (< 30 ng/ml) will be randomly supplemented with Vitamin D3 or~     placebo for 8 weeks in 1:1 pattern. The clinical treatment i.e., antipsychotic medications~     will be continued as usual within the two groups. Participants in both the groups will be~     assessed at study entry, at the end of the 04 and 08 weeks (after completing supplementation)~     on the Positive and Negative Syndrome Scale (PANSS), Computerized Neurocognitive Battery~     (CNB) & Clinical Global Improvement (CGI) subscale (CGI-I). Raters will be blind to the group~     assigned to participants. Side effects will be monitored at every visit.The serum levels of~     vitamin D will be measured at baseline and at the end of 08 weeks.~   "
35548|NCT03101306|"~     The standard treatment for locally advanced cervical cancer is concurrent chemo-radiotherapy.~     This treatment is associated with long term side effects in around half of patients with up~     to 10% suffering from grade 3-4 toxicity.~      The development of intensity modulated radiotherapy (IMRT) allows for shaping of radiotherapy~     fields to reduce the doses delivered to organs at risk (OARs). This does appear to reduce the~     risk of long and short term toxicity (although there is little randomized evidence). However~     pelvic organ position varies both between and even during radiotherapy fractions; this means~     that radiotherapy margins must be generous to allow adequate coverage of the clinical target~     volume (CTV) but this also increases dose to OARs.~      There have been a number of studies evaluating pelvic organ motion in cervical cancer as well~     as assessing different adaptive radiotherapy strategies. These have included individualized~     margins, plan of the day and adaptive techniques. Most of these studies have been carried out~     using cone beam computed tomography (CBCT) imaging which is often poor quality with limited~     soft tissue contrast. MR offers better visualization of the tumour and OARs and is used for~     imaged guided brachytherapy treatment.~      This study will explore the role of MR imaging in adaptive radiotherapy for cervical cancer~     with development of a number of theoretical treatment strategies.~   "
35549|NCT03101293|"~     The purpose of this study is to determine the pharmacokinetic (PK) of a single oral dose of~     TAK-831 400 milligram (mg) in the fasted state and to estimate the effect of food on the PK~     of a single oral dose of TAK-831 400 mg when administered as tablet formulation in healthy~     participants.~   "
35550|NCT03101280|"~     This is a Phase Ib, open-label, non-randomized study in patients with previously treated~     advanced ovarian or endometrial cancer (Part 1) and platinum-sensitive ovarian cancer or~     triple-negative breast cancer (TNBC) (Part 2) to investigate the dose, safety,~     pharmacokinetics, and preliminary efficacy of rucaparib in combination with atezolizumab. The~     study is conducted in 2 parts: a Dose-Finding Phase (Part 1) and a Dose-Expansion Phase (Part~     2)~   "
35551|NCT03101267|"~     The objective of this study is to evaluate the efficacy, safety, and dose-response of ASP4070~     vaccinated in patients with cedar pollinosis.~   "
35552|NCT03101254|"~     This research study is studying a combination of targeted therapies as a possible treatment~     for advanced melanoma that was found to have a BRAF V600E or BRAF V600K genetic mutation~      The interventions involved in this study are:~        -  LY3022855~        -  Vemurafenib~        -  Cobimetinib~   "
35553|NCT03101241|"~     This is a multicenter, double-blind, placebo-controlled, parallel-group study consisting of a~     screening period of up to 4 weeks (with the exception of subjects on primidone at baseline~     who will be allowed 6 weeks of screening to allow for safe discontinuation). Screening~     results from all patients meeting the eligibility requirements will be further assessed by~     the sponsor medical personnel for final approval of suitability for inclusion in the study.~     Randomized subjects will enter a 4 week double-blind dose-titration treatment period,~     followed by a 1 week safety follow-up period following the last dose of study medication, and~     a scheduled follow-up safety telephone call one week later.~   "
35554|NCT03101228|"~     The most important objective of this randomized controlled trial in subjects with increased~     cardiovascular and metabolic risk factors is to investigate whether only reduced daily~     sitting improves human cardiovascular and metabolic health during a six-month intervention.~     It is hypothesized and expected that only reduced sitting, without formal physical activity~     or exercise training, affects favorably cardiovascular and metabolic health.~   "
35644|NCT03100045|"~     This open label study investigates a novel non-surgical approach to the treatment of~     HPV-associated anal intraepithelial neoplasia, using Artesunate suppositories.~   "
35559|NCT03101163|"~     This is a 24-month, multicenter, randomized, open-label, standard treatment-controlled,~     parallel-group, Phase 2 study for adults with large or complicated knee articular cartilage~     lesions and are candidates for knee joint cartilage repair surgery. The safety and efficacy~     of intra-articular injections of peripheral blood stem cells (PBSCs) together with hyaluronic~     acid (HA) after subchondral drilling surgery will be evaluated to determine whether PBSC~     therapy can improve functional outcome and reduce pain of the knee joint better than a~     standard treatment (HA injections and physiotherapy regimen).~   "
35560|NCT03101150|"~     Vitamin D deficient pregnant ladies were selected and randomized into 2 groups for routine~     daily dose of multivitamin (400IU vitamin D3) versus maximum safest treatment daily dose~     (4000IU vitamin D3). Participants were assessed and compared for number of pre-eclampsia~     cases.~   "
35561|NCT03101137|"~     Caudal epidural anesthesia is one of the most common regional techniques used for~     post-operative pain management in pediatric patients. In this study we are going to compare~     the effects of caudal bupivacaine , caudal Dexamethasone with bubivacaine and Dexmedetomidine~     with bupivacaine on the systemic vascular resistance and the cardiac output, in pediatric~     patients undergoing lower abdominal surgeries, by using the electrical cardiometry (EC).~   "
35562|NCT03101124|"~     Tranexamic acid is a drug that prevents clotted blood from dissolving and hence reduces~     bleeding. It is routinely given intravenously in many surgical situations where there is a~     risk of major bleeding. Concerns regarding possible adverse effects from intravenous use~     prevents a more widespread use, even in smaller surgeries. Topical application - using the~     drug directly on the wound surface- may give a higher concentration at the site of bleeding~     but a lower concentration in the rest of the body, and hence a lower risk of adverse effects.~     Here it will be investigated to what extent a defined dose of the drug is absorbed~     systemically - into the blood stream - when it is applied topically. This will then be~     compared to the concentration in the blood stream when administered intravenously. Blood~     samples will be obtained at defined time intervals after administration from patients~     receiving topical and patients receiving intravenous administration of the same single dose~     of tranexamic acid. Will less of the drug enter the blood stream if it is applied directly to~     the wound?~   "
35563|NCT03101111|"~     The clinical study primarily assesses the safety of MV-CHIK a new Chikungunya vaccine in a~     previously epidemic area in healthy volunteers. Secondarily, immune response and viremia will~     be assessed.~      MV-CHIK will be compared to the commercially available MMR vaccine. 80% of the subjects will~     receive MV-CHIK; 20% will receive MMR vaccine.~   "
35564|NCT03101098|"~     This randomized trial is aimed to investigate the role of retroperitoneal TLH in enlarge~     uterus.~   "
35565|NCT03101085|"~     By doing this study researchers hope to learn if S-equol, a compound that acts like estrogen~     in the body, causes an increase in mitochondrial activity. Researchers also hope to determine~     the safety and tolerability of a therapeutic dose of S-equol and whether or not it influences~     cognition.~   "
35566|NCT03101072|"~     Gram-negative bacteremia (GNB) is a frequent hospital & community-acquired infection, yet~     there is as yet no evidence from randomized studies on the optimal duration of antibiotic~     therapy. This point-of-care, multicenter randomized controlled non-inferiority trial will~     randomize 500 patients with GNB on day 5 of appropriate antibiotic therapy to either (1) a~     total of 7 days of antibiotic therapy, (2) a total of 14 days of antibiotic therapy, or (3)~     an individualized duration of antibiotic therapy (guided by the patient's clinical course &~     C-reactive protein levels). The primary outcome is the incidence of clinical failure at day~     30.~   "
35567|NCT03101059|"~     Mounier-Kuhn syndrome (MKS), or congenital tracheobronchiomegaly, is an entity characterized~     by dilation of the trachea and bronchi, associated with respiratory infections.The main signs~     and symptoms are cough, bulging and purulent expectoration, digital clubbing, dyspnoea, and~     wheezing.Some of these symptoms are believed to be due to excessive collapse of the~     intra-thoracic trachea and bronchi, resulting in airways obstruction of more than 50% . The~     purpose of this study is to identify and reduce tracheal collapse.~   "
35568|NCT03101046|"~     This study compares the biological activity of cabazitaxel (6 cycles) to that of docetaxel (6~     cycles) in metastatic castrate-resistant prostate cancer (mCRPC) patients with docetaxel~     resistant mCPRC defined as ≥ 5CTCs/7.5ml after 2 cycles of docetaxel.~      Patients with docetaxel resistant metastatic castration-resistant prostate cancer (mCRPC)~     based on circulating tumor cell (CTC) enumeration (patients with ≥ 5CTCs/7.5ml before~     docetaxel chemotherapy and after 2 cycles of docetaxel) will receive either 6 additional~     cycles of docetaxel or 6 additional cycles of cabazitaxel after randomisation.~      A cohort of patients with docetaxel sensitive metastatic castration-resistant prostate cancer~     (mCRPC) based on circulating tumor cell (CTC) enumeration (patients ≥ 5CTCs/7.5ml before~     docetaxel chemotherapy and < 5CTCs/7.5ml after 2 cycles of docetaxel) will receive 6~     additional cycles of docetaxel~   "
35569|NCT03101033|"~     The purpose of this study is to determine whether epidural neuroplasty has better efficacy~     than epidural steroid injection for the treatment of lumbar disc herniation.~   "
35570|NCT03101020|"~     Non-specific chronic low back pain is a common multifactorial condition common to the world~     population. It is defined as a pain and discomfort located below the ribs and above the~     gluteal folds that may or may not have referred pain in the leg for more than 12 weeks.~     Visceral manipulation is a manual therapy technique that aims to normalize mechanical,~     vascular and neurological dysfunctions of the viscera with the objective of improving its~     functioning. Visceral dysfunction may potentially activate or exacerbate the symptoms of low~     back pain in the presence of compromised movements between the internal organs and its~     connective tissues. There are two ways in which a change in visceral mobility could interfere~     with low back pain, referred visceral pain and central hypersensitivity. The first occurs due~     to neural convergence, since there is no spinocortical tract that only sends visceral or~     somatic afferences, its afferences are crossed in the dorsal horn of the spinal cord. The~     second is that the prolonged and continuous activation of nociceptors, due to the alteration~     in the mobility of the gastrointestinal and urinary system, can generate central~     hypersensitivity. Therefore, the investigators hypothesized that through the visceral~     manipulation the fascial adherences would lyse and the visceral spasms would demise, reducing~     the peripheral input, thus, lessening pain in the low back.~   "
35571|NCT03101007|"~     The LCS Complete Cementless Knee by DePuy Synthes is a rotating platform knee replacement~     with a good clinical track record and good survival rates.~      The cementless ATTUNE Cruciate Sacrificing (CS) Rotating Platform Knee by DePuy Synthes has~     been designed to provide better range of motion and address the unstable feeling some~     patients experience during everyday activities, such as stair descent and bending. It is~     expected that the cementless ATTUNE Rotating Platform Knee will have regulatory approval~     early 2016. Patient inclusion will start after regular approval has been obtained.~      The objective of this study is to accurately assess and compare migration, clinical and~     radiological outcome and patient reported outcomes (PROMS) of two TKR prostheses: the~     Cementless ATTUNE Rotating Platform Cruciate Sacrificing Knee System and the LCS Complete~     Cementless Cruciate Sacrificing Knee System (rotating platform design), both by DePuy~     Synthes, Warsaw, Indiana, USA. In this single-blind, randomized non-inferiority trial, 32~     patients with the ATTUNE Knee System and 32 patients with LCS Knee System will be included.~      The study population will consist of patients with symptomatic osteoarthritis of the knee~     scheduled for TKR surgery at the Department of Orthopaedics, Spaarne Gasthuis, Hoofddorp, The~     Netherlands. Annually 300 TKA procedures are performed in this department, of which about 95%~     is Osteo Arthritis (OA). The investigator anticipates that inclusion can be accomplished~     within a 1 year period and that the total study duration is 3 years.~      Main study parameters/endpoints are:~        -  Migration, measured by means of RSA.~        -  Patient Reported Outcome Measures by means of questionnaires.~   "
35572|NCT03100994|"~     Post-operative analgesia efficacy using ultrasound-guided transmuscular quadratus lumborum~     block versus ultrasound-guided quadratus lumborum type II block~   "
35573|NCT03100981|"~     AIM: The aim of the present study is to investigate if Internet-delivered Mindfulness-Based~     Cognitive Therapy (I-MBCT) can reduce symptoms of depression and anxiety among women treated~     for breast cancer and men treated for prostate cancer compared to a treatment as usual~     control group. Furthermore, the effect of I-MBCT on symptoms of stress, insomnia, quality of~     life, and self-compassion and the potential mediating effect of working alliance and~     mindfulness will be explored. Finally, the cost-effectiveness of the I-MBCT intervention will~     be explored.~      BACKGROUND: Symptoms of depression, anxiety, and stress are prevalent late-effects among~     cancer patients and -survivors. Mindfulness-based interventions aim at improving affect~     tolerance and emotion regulation, which could be of particular relevance for cancer patients~     and survivors, and MBCT has been shown efficacious in treating symptoms of depression,~     anxiety, and stress among cancer patients and survivors. However, the availability of~     face-to-face delivered MBCT is limited and hence using the internet to deliver MBCT may be a~     cost-effective way of increasing the accessibility of the intervention to vulnerable patients~     with limited resources.~      METHODS: A total of 155 participants will be recruited from Department of Oncology and~     Department of Urology at Aarhus University Hospital and randomized to two groups: I-MBCT and~     a treatment-as-usual wait-list control group. Assessments will be conducted at pre-, midway~     and post intervention and at a 6- months follow-up.~   "
35574|NCT03100968|"~     This study will address the utility of ultrasound in the placement of an epidural catheter in~     severely obese parturients. Identification of midline can often be difficult using the~     standard method of palpation in obese patients. The Investigator will determine if the use of~     ultrasound decreases the amount of time and number of attempts required to place the~     epidural.~   "
35575|NCT03100955|"~     To establish the progression free survival in patients with extensive stage small cell lung~     cancer treated with cisplatin and etoposide plus or not apatinib~   "
35576|NCT03100942|"~     The primary objective of this study is to assess the efficacy of filgotinib, GS-9876, and~     tirabrutinib (formerly GS-4059) in adults with active Sjogren's Syndrome (SjS).~   "
35577|NCT03100929|"~     The investigators aim to prove that minimal sonographic training for nuchal cord detection in~     an unexperienced first year medical resident is more than enough to detect the phenomenon.~     Patients undergoing elective cesarean section will undergo a routine ultrasound (that is~     performed to detect the fetal heart rate and the fetal presentation) during which the~     resident will attempt to detect nuchal cord. The resident will then attend the patient`s~     surgery to verify the findings.~   "
35578|NCT03100916|"~     The primary objective of the trial is to investigate the safety and tolerability of BI 690517~     in healthy male subjects following oral administration of multiple rising doses over 14 days~     (MRD part).~      Secondary objectives for the MRD part are the exploration of PK (Pharmacokinetic(s)),~     including dose proportionality, as well as investigation of linearity and PD~     (Pharmacodynamic(s)) of BI 690517 after multiple dosing.~      For the FE (food effect) part, the secondary objective is to investigate the relative~     bioavailability of BI 690517 under fasted conditions (Reference, R) compared to BI 690517~     (single dose) after a high fat high caloric breakfast (Test, T).~   "
35579|NCT03100903|"~     The primary objective of this trial is to investigate the relative bioavailability of BI~     655130 following subcutaneous administration (Test, T) compared to BI 655130 following~     intravenous infusion (Reference, R).~      The secondary objective is the evaluation and comparison of several pharmacokinetic~     parameters between all tested treatments.~   "
35580|NCT03100890|"~     In this work the importance of the potentiation and recovery of the balance with a~     physiotherapeutic intervention that begins in the early preoperative phase is compared with~     the conventional postoperative rehabilitation. The objective is to evaluate the influence of~     a muscle enhancement protocol in which a specific work of balance is included, with the~     physical benefits that this entails for the evolution of the patient. It also seeks to verify~     if the teaching and recommendation of exercises at home as preparation and conditioning for~     the intervention of ATR is effective, and to what extent, compared to a guided training in~     the hospital.~   "
35607|NCT03100526|"~     Purpose: Implement a Patient Aligned Care Team (PACT) model that identifies and proactively~     manages Veterans at the highest risk for hospital admission and death while they are still in~     the ambulatory care setting.~      Goal:~        -  Reduce emergency department and urgent care utilization, hospitalization, and mortality~          in complex, high risk patients~        -  Improve Veteran and staff satisfaction~      Objectives:~        -  Maintain the patient in the home setting as much as possible~        -  Secure appropriate home environment to facilitate health and well-being~        -  Utilize comprehensive team-based care~        -  Engage appropriate Veteran Health Administration (VHA) programs to provide~          interdisciplinary, coordinated, and timely management of complex medical issues~   "
35581|NCT03100877|"~     This phase I/II trial studies the side effects and best dose of melphalan and total marrow~     irradiation and how well they work with autologous stem cell transplantation in treating~     patients with high-risk multiple myeloma. Drugs used in chemotherapy, such as melphalan, work~     in different ways to stop the growth of cancer cells, either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading. Total marrow irradiation is~     a type of radiation therapy and a form of total body irradiation that may deliver focused~     radiation to the major marrow sites where cancer cells reside. Giving chemotherapy and~     total-body irradiation before a peripheral autologous blood stem cell transplant helps kill~     any cancer cells that are in the body and helps make room in the patient's bone marrow for~     new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from~     the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow~     for the stem cell transplant. The stem cells are then returned to the patient to replace the~     blood-forming cells that were destroyed by the chemotherapy.~   "
35582|NCT03100864|"~     The primary objective of this trial is to understand the mechanism of action of BI655130 in~     patients with UC~      Secondary objectives are to explore clinical effect, safety and tolerability (including~     immunogenicity) of BI 655130 treatment~   "
35583|NCT03100851|"~     Constipation is a prevalent intestinal disorder. Lactobacillus casei strain Shirota (LcS)~     shows potential effect on alleviating constipation. This study evaluated the impact of~     fermented milk containing LcS on stool consistency and frequency. The stool short chain fatty~     acid and gut microbiota were also assessed.~   "
35584|NCT03100838|"~     The purpose of this study is to measure the amount of study drug present in blood after being~     administered a generic version of nifedipine extended-release tablets, 60 mg (Valeant~     Pharmaceuticals, LLC) and brand-name version PROCARDIA XL extended-release tablets, 60 mg~     (Pfizer Inc.) individually and in presence of stomach acid reducing drug (antacid),~     omeprazole/sodium bicarbonate capsules, 40 mg/1100 mg (generic) on separate occasions, on an~     empty stomach. This study also involves administrations of an FDA-cleared capsule,~     SmartPill™, which will measure stomach acid, prior to each study arm.~   "
35585|NCT03100825|"~     The purpose of this study is to provide long term safety data of QVM149 in Japanese patients~     with asthma for the registration of QVM149 in Japan.~   "
35586|NCT03100812|"~     The proposed intervention is part of a multi-year year grant awarded to the NYU Center for~     the Study of Asian American Health by to the National Institutes of Health/National Center~     for Minority Health and Health Disparities (NIH/NCMHD). The funding mechanism is specifically~     the NCMHD Community-Based Participatory Research (CBPR) Initiative in Reducing and~     Eliminating Health Disparities: Intervention Research Phase (R24).~      The objective of this study is to implement and assess the efficacy of a Community Health~     worker (CHW) intervention to improve hypertension management and access to care among~     Filipino Americans living in New York and New Jersey. It is believed that when compared to~     individuals receiving the less intensive CHW intervention, Filipino Americans receiving the~     more intensive CHW intervention will:~      H1: Exhibit greater compliance with appointment keeping. H2: Exhibit greater compliance with~     medication taking H3: Show greater reductions in mean systolic and mean diastolic blood~     pressure. H4: Be more likely to exhibit controlled blood pressure~   "
35587|NCT03100799|"~     This is an exploratory non-drug, interventional biomarker study in approximately 30 eligible~     patients with active osteoarthritis to investigate the degree of senescence-associated~     disease. Patients will provide blood and urine and undergo MRI imaging with and without~     gadolinium enhancement. Following imaging, arthrocentesis of both knees and an arthroscopy of~     the target knee will occur to obtain fluid, synovium and cartilage for analysis.~   "
35588|NCT03100786|"~     The primary objective is to determine whether Leukotriene A4 hydrolase (LTA4H) genotype,~     defined at randomisation, determines dexamethasone's clinical effectiveness when added to the~     first 6-8 weeks of anti-tuberculosis treatment of TBM. The investigators will conduct a LTA4H~     genotype stratified, parallel group, randomised, double blind, placebo-controlled~     multi-centre Phase III non-inferiority trial evaluating dexamethasone versus placebo for 6-8~     weeks in addition to standard anti-tuberculosis drugs.~      The investigators will take a hybrid trial-design approach which assumes a modest harm of~     dexamethasone and aims to prove non-inferiority of placebo first but also allows claiming~     superiority of placebo in case dexamethasone causes substantial harm. Moreover, as it is~     possible that harm of dexamethasone only applies to the LTA4H CC genotype, the trial will~     allow dropping the CT group at an interim analysis but continue randomization of the CC~     group.~      In making this assessment the investigators not only determine whether dexamethasone~     influences survival and the incidence of new neurological events (the primary endpoint), but~     also whether it influences disability assessed by the modified Rankin score 12 months after~     the start of treatment.~      The secondary objective is to investigate alternative management strategies in a subset of~     patients who develop drug-induced liver injury that will enable the safe continuation of~     rifampicin and isoniazid therapy whenever possible.~   "
35589|NCT03100773|"~     This study evaluated the impact of atraumatic restorative treatment associated with oral~     health educational strategy on dental anxiety, oral health-related quality of life and~     salivary biochemical and microbiological characteristics of Brazilian schoolchildren.~   "
35590|NCT03100747|"~     The purpose of this study is to determine whether the rate of post-operative trachomatous~     trichiasis differs significantly between bilamellar tarsal rotation surgery with an incision~     height of 3mm, bilamellar tarsal rotation surgery with an incision height of 5 mm, and Trabut~     surgery.~   "
35591|NCT03100734|"~     The primary objective is to evaluate the effectiveness of Benepali in participants with~     Rheumatoid Arthritis (RA) and axial spondyloarthritis (axSpA), including participants with~     Ankylosing Spondylitis (AS) and non-radiographic axSpA, following their transition from~     treatment with Enbrel.~      The secondary objectives of this study are to describe clinical characteristics of patients~     transitioned from Enbrel to Benepali in routine practice, to evaluate safety during and~     following the transition from Enbrel to Benepali and to evaluate patient-reported outcomes~     during and following the transition from Enbrel to Benepali.~   "
35645|NCT03100032|"~     A prospective multi-centre, randomised, controlled study to evaluate the safety and~     preliminary effectiveness of NVD-001 for the treatment of low grade degenerative lumbar~     spondylolisthesis by interbody fusion (L1 - S1).~   "
35592|NCT03100721|"~     Chronic musculoskeletal pain (CMP) is highly prevalent, disabling and with high~     socio-economic costs, with many negative effects on quality of life. CMP affects the ability~     to perform work, social, recreational and domestic tasks by changing the mood and~     concentration of this population that suffers.~      In a study carried out in 2010, 17% of the Spanish population had experienced pain in the~     last month and according to the severity of symptoms 12% felt severe , 64% moderate and 24%~     mild pain. In this same study it is specified that 61% was due to back pain, 29% due to neck~     pain and 23% due to shoulder pain.~      Pain neuroscience education (PNE) has been shown as an effective treatment strategy in~     increasing knowledge and understanding of neurobiology, neurophysiology and pain processing,~     modifying beliefs about it, improving patient skills and encouraging to the accomplishment of~     physical and social activities in different chronic pathologies.~   "
35593|NCT03100708|"~     The study will follow up patients with peritoneal carcinomatosis from colorectal, ovarian,~     gastric, pancreatic cancers and primary peritoneal tumors and undergoing a diagnostic~     laparoscopy / laparotomy, a PIPAC as single dose or repeated every 6 weeks. The Overall~     Response Rate (ORR), the Overall Survival (OS) and the Quality of Life will be assessed~     before every PIPAC. Biopsies of the peritoneal carcinomatosis and blood (plasma and serum)~     are collected with every PIPAC intervention to follow up and to document the individual~     success or progress of the patients. The advice of the tumor board is mandatory to confirm~     the indication for local chemotherapy (PIPAC).~   "
35594|NCT03100695|"~     A prospective, randomised study is to investigate the feasibility of conducting a superiority~     randomised controlled trial comparing the application of combined autologous PRP and~     concentrated autologous bone marrow (PRP-BMA) in addition to standard of care (either reamed~     intramedullary nailing or fine wire ring external fixator) for patients presenting with fresh~     tibial diaphyseal fractures.~   "
35595|NCT03100682|"~     Due to their immunosuppressive therapy, solid-organ transplant (SOT) recipients bear a 10 to~     100 times higher risk of human papillomavirus (HPV)-associated malignancies than healthy~     individuals. The objectives of this observational, non-interventional multi-national,~     multi-centre research project are to gain an insight into current HPV vaccination strategies~     and to investigate the immune response to different routinely administered HPV vaccines in~     European paediatric SOT candidates and immunocompromised transplant recipients, enabling~     patients at risk of vaccination failure to be identified.~   "
35596|NCT03100669|"~     MIRP (Minimally Invasive Repair of Pectus) as surgical correction of pectus excavatum or~     carinatum is performed to achieve physiological, cosmetic, and psychological benefits for the~     patient. Surgery is often associated with severe postoperative pain. In this study the~     researchers want to registrate pain, sleep, nausea/vomiting, and daily activities in short~     and long term follow up.~   "
35597|NCT03100656|"~     This study uses a meal-challenge protocol to assess if patients with anorexia nervosa show a~     differential meal-induced metabolism and response compared to healthy controls, and~     determines how genetic variation influence this difference.~   "
35598|NCT03100643|"~     HIV/AIDS among Black men is a US public health crisis, emphasizing the urgency for increased~     research focus and intervention development. The overall objective of this application is to~     achieve a better understanding of the role that dyadic factors play in individual-level HIV~     care engagement outcomes among HIV-positive Black men in romantic relationships. The end goal~     is the development of an intervention that employs innovative mobile technology to target~     partnership dynamics that optimize outcomes in the HIV care continuum.~   "
35599|NCT03100630|"~     Randomized study in healthy men and women. Assess the similarity of BMS-986089 when injected~     into the arm, thigh, or the stomach. Collect data on safety of BMS-986089.~   "
35600|NCT03100617|"~     This is a single arm pilot study of 6-8 families to test the feasibility and acceptability of~     a Alzheimer's family caregiver intervention in Vietnam.~   "
35601|NCT03100604|"~     The investigators aimed to examine the effect of sevoflurane and desflurane, agents used in~     patients who do not have any ear pathology and undergo surgery under general anesthesia, on~     the MEP.~   "
35602|NCT03100591|"~     The primary purpose of this study is to investigate the rate and routes (urine and feces) of~     elimination of ACT-132577, and the mass balance in urine and feces~   "
35603|NCT03100578|"~     RANDOMIZED MULTICENTER STUDY COMPARING PLASTIC STENTS AND SELF-EXPANDING METALLIC STENTS IN~     THE EUS-GUIDED TRANSMURAL DRAINAGE OF WALLED-OFF PANCREATIC NECROSIS.~      SPANISH CENTERS PARTNERS OF THE SPANISH SOCIETY OF DIGESTIVE ENDOSCOPY~   "
35604|NCT03100565|"~     Cervical cancer is the third most common genital cancer worldwide. The diagnosis of cervical~     cancer is performed with the cervical biopsy which is guided by the colposcopy. The~     colposcopy guided cervical biopsy creates pain and several methods have been reported to~     overcome the pain related with this procedure. Local anesthetic agent injection into the~     cervix has been studied and found to be effective and also, forced coughing was compared with~     local anesthetic injection and it is found to be more effective. In fact local injections can~     create the pain by itself.However no study compared the effect of forced coughing to local~     anesthetic spray. The study aims to evaluate the comparison of forced coughing with local~     anesthetic spray with respect to perceived pain during colposcopy guided biopsy.~   "
35605|NCT03100552|"~     Study of endoscopic imaging in the detection of dysplasia within serrated colonic lesions >=~     8mm in size~   "
35606|NCT03100539|"~     Given the modest effectiveness of current treatments and the burden chronic neck pain places~     on Veterans, the investigators' research proposal is significant in several regards. First,~     Trial Outcomes for Massage: Caregiver-Assisted vs. Therapist-Treated (TOMCATT) Study directly~     addresses a high priority area for the VA and is well aligned with the VHA Pain Management~     Strategy and VHA Pain Management Directive 2009-053. Second, because previous massage studies~     have included relatively small sample sizes, this trial will provide information vital to~     fill an evidence vacuum regarding effectiveness of two different massage treatments for~     chronic neck pain. Third, TOMCATT will extend the current understanding of~     non-pharmacological treatments. Fourth, if the study hypotheses are corroborated massage may~     emerge as an effective, safe, affordable, sustainable, and accessible treatment for Veterans.~   "
35693|NCT03099408|"~     We are trying to determine if Oral Metronidazole with Lactobacillus Vaginal Suppositories is~     better than Oral Metronidazole in Preventing the Recurrence of Bacterial Vaginosis~   "
35608|NCT03100513|"~     The current standard of care for patients with HE includes non-absorbable~     disaccharides(lactulose);The chemical name for lactulose is~     4-O-β-D-galactopyranosyl-D-fructofuranose.The exact mode of action by lactulose is thought to~     be the conversion to lactic acid and acetic acid by colonic bacteria resulting in~     acidification of the gut lumen. This favors conversion of ammonia (NH3) to ammonium (NH4+),~     which is relatively membrane impermeable; therefore, less ammonia is absorbed by the colon.~     Gut acidification inhibits ammoniagenic coliform bacteria, leading to increased levels of~     nonammoniagenic lactobacilli. Nonabsorbable disaccharides also work as a cathartic, clearing~     the gut of ammonia before it can be absorbed.~   "
35609|NCT03100500|"~     The purpose of this study is to provide long term safety data of QMF149 in Japanese patients~     with inadequately controlled asthma for the registration of QMF149 in Japan.~   "
35610|NCT03100487|"~     The purpose of this study is to:~        1. Determine if audio recorded guided imagery vs deep breathing exercises delivered via a~          digital media player improves abdominal pain symptoms in children with functional~          gastrointestinal pain disorders managed in the primary care setting.~        2. Determine if audio recorded guided imagery and deep breathing exercises delivered via a~          digital media player improves psychosocial distress in children affected by functional~          gastrointestinal pain disorders managed in the primary care setting.~      The possibility of treating functional gastrointestinal pain disorders using remotely~     delivered psychosocial therapies has the potential to treat many children affected by~     functional gastrointestinal pain disorders in a cost-effective manner. This study will~     provide insight into how well these patients in the primary care could benefit from such~     interventions.~   "
35611|NCT03100474|"~     A global post approval study to collect safety and effectiveness data related to ExAblate~     Neuro for the treatment of certain disorders such as Essential Tremor, Parkinson's Movement~     Disorders, or Neuropathic Pain within the thalamus and/or pallidum.~   "
35612|NCT03100461|"~     The goal of this study is to find the best ways to increase colorectal cancer (CRC)~     screening.~   "
35613|NCT03100448|"~     A 1-year Clinical Investigation on the On1 Concept.~   "
35614|NCT03100435|"~     The American Association of Oral and Maxillofacial Surgeons estimated that 69% of adults ages~     35 to 44 have lost at least one permanent tooth. Dental implants have revolutionized~     dentistry by providing tooth-like replacement for missing teeth and a solution that is~     predictable with long-term success..~      After the implant is placed, natural bacteria from the mouth can develop around implants just~     like around natural teeth. Studies have shown that bacterial contamination can cause~     peri-implantitis- gum disease or inflammation around the implant, eventually leading to bone~     loss. Removing bacteria from dental implant surfaces can prevent peri-implantitis, and~     surface debridement constitutes the basis of treatment of peri-implant disease.~      Typically, mechanical hand instrumentation using curettes to remove biofilm and calculus is~     the main basis for periodontal therapy. However, total debridement is difficult, and the hand~     tools may damage the surface of the implant and making it more plaque retentive. Studies have~     shown that mechanical non-surgical therapy alone is not sufficient to treat peri-implantitis.~      There is evidence that a dental laser may be an effective method to remove bacteria from~     implant surfaces, with less damage to the surface. One type of dental laser, Er:YAG, appears~     optimal for implant decontamination as the Er:YAG laser energy is primarily absorbed by~     water, resulting in vaporization of bacteria and minimal surface alterations on the implant~     surface.The aim of this study is to evaluate the efficiency of biofilm decontamination of~     Er:YAG laser compared to carbon fiber curette.~   "
35615|NCT03100422|"~     Neurological patients (e.g., after stroke) need long-term neurorehabilitation therapy of the~     arm with often limited, unsatisfactory outcome. Robots became a promising supplement or even~     alternative for neurorehabilitation training.~   "
35616|NCT03100409|"~     In Mexico, cervical cancer (CC) ranks second in incidence and mortality among women. The~     National Institute of Cancer in Mexico (lNCan) receives annually about 500 patients with CC,~     80% of which are diagnosed with locally advanced disease. The standard treatment for locally~     advanced disease consists in concomitant chemo-radiotherapy based on cisplatin (QT-RT),~     followed by brachytherapy, with an absolute benefit of 10%. Adverse effects include~     gastrointestinal toxicity, which is the most important factor limiting the dosage of pelvic~     radiation. Cancer treatment, in any modality, induces malnutrition, more so when combined~     treatments are administered. Radiation induced gastrointestinal toxicity is caused by~     different factors, among which are malabsorption of bile, fat and carbohydrates, decrease in~     brush border enzymes, diverticular disease, proctitis, and psychological factors.~     International guidelines for cancer patients recommend nutritional assessment in these~     patients before they start treatment, so nutritional risk can be detected and the patient may~     get started on dietary intervention to prevent malnutrition. Several authors have studied the~     dietary management that may help reduce the gastrointestinal effects in cancer patients~     receiving pelvic radiotherapy. To reduce diarrhea and prevent malnutrition the recommended~     dietary approach is a low residue diet consisting on 20-25% kcal from fat, 5g of lactose and~     20g of fiber. Currently the INCan does not follow the nutrition care process for cervical~     cancer patients; written recommendations are given to the patients with a list of foods~     allowed or not allowed, with no further nutritional assessment or intervention. From previous~     studies, the investigators have demonstrated that the current recommendations do not help the~     patients maintain their nutritional status, during their treatment most patients become~     malnourished (81%, p<0.01). Therefore, the aim of this clinical trial is to evaluate a diet~     low in residue in CC patients, considering the necessary modifications for each patient if~     morbidities are present, in comparison with the current dietary recommendations used in the~     INCan.~   "
35617|NCT03100396|"~     DREAMY is a prospective, multi-centre observational cohort study using a mixed methods~     approach to provide quantitative and qualitative data on accidental awareness under general~     anaesthesia (AAGA) in obstetric surgery patients. Obstetric patients undergoing surgery, such~     as emergency caesarian section under general anaesthesia, are thought to be at higher risk~     than any other surgical cohorts for AAGA. Patients recruited to the study will be screened~     for AAGA using a standardised questionnaire on three occasions over 30 days. Follow up with~     structured interviews for all AAGA patients will occur over 12 months.~   "
35618|NCT03100383|"~     To assess the association of the number of medical nutrition therapy (MNT) consultations and~     eating behavior (cognitive restraint, uncontrolled eating, and emotional eating) with GWG in~     women with type 2 diabetes mellitus (T2DM) and gestational diabetes mellitus (GDM).~   "
35619|NCT03100370|"~     This study will compare different polarities of transcutaneous spinal direct current~     stimulation combined with robotic-assisted arm training in adults with acquired brain injury~     (ABI). Participants will receive 20 minutes of 2.5 milliamps (mA) anodal, cathodal, and sham~     transpinal direct current stimulation (tsDCS) over cervical spine combined with high~     intensity robotic-assisted arm training, five days a week, for 2 consecutive weeks.~   "
35622|NCT03100331|"~     Children who are perinatally-infected with HIV are extremely vulnerable to cognitive delays~     and psychiatric disease, and the risk for neuropsychiatric illness is compounded in children~     who are internationally-adopted and may have suffered trauma, abandonment, malnutrition and~     neglect. While cognitive and psychiatric issues have been described in HIV-infected children,~     and even more so in HIV-positive adults, there have been no reports on neuropsychiatric~     interventions that can improve cognitive and psychiatric states in this highly vulnerable~     population. Without these needed data, Pediatric HIV providers have not been able to advocate~     for optimal neuropsychiatric care in perinatally HIV-infected children, let alone those who~     has suffered the additional risk of being internationally adopted. In the proposed study, the~     investigators will report on the neuropsychological profiles and outcomes in a cohort of~     internationally-adopted, perinatally HIV-infected children between ages 6 to 16 years who~     have not previously undergone neuropsychological testing or treatment. Data obtained from~     this study will provide important contributions to the literature by building understanding~     of the complex needs of this population as well as guiding future intervention efforts. The~     investigators predict that intervention efforts aimed at helping educators understand the~     learning and cognitive challenges for many of our patients will guide targeted academic~     supports in the school setting and lead to gains in academic skills. The detailed information~     obtained during the comprehensive neuropsychological assessment and follow-up care will be~     shared with the child's key educators at school so that individualized educational strategies~     can be developed, while maintaining confidentiality regarding the child's HIV status.~   "
35623|NCT03100318|"~     FYU-981 or Benzbromarone are administrated to hyperuricemia patients with or without gout for~     14 weeks to compare the efficacy and safety of these drugs by the method of multicenter,~     randomized, double-blind, ascending dose regimen.~   "
35624|NCT03100305|"~     The aim of this study is to investigate the changes of amino acid metabolic profiles in~     different nutritional stages of preterm infants and determine the effects of nutritional~     intervention on the amino acid metabolic status of preterm infants.~   "
35625|NCT03100292|"~     This trial is a multi-center, single-arm, prospective, observational cohort study of patients~     undergoing primary bariatric surgical procedures in Korea. A total of 100 patients will be~     recruited over a 1-year period from 2016 to 2017, and will be followed for a mean follow-up~     period of 1 year after surgery. The eligible subjects who have given their consent to~     participate will undergo one of two surgical procedures; sleeve gastrectomy and Roux-en Y~     gastric bypass.~      The primary objective of this clinical trial is to measure the changes in body weight (kg)~     and waist circumference (cm) of the enrolled patients at postoperative 1 year. Secondary~     outcomes are improvement or remission rates of obesity-related co-morbidity (hypertension,~     type 2 diabetes, dyslipidemia, and sleep apnea), and the change in quality of life.~     Additionally, postoperative incidences of morbidity and mortality, micronutrient status, body~     composition, and cost-effectiveness of surgical intervention will be examined.~   "
35626|NCT03100279|"~     The current study will evaluate the predictors, mediators, outcomes, and critical therapy~     processes associated with manual-based psychological therapies for 400 youth (ages 7-16~     years) with anxiety and/or depression seeking services within a semi-natural clinic setting.~     Essentially, this study seeks to determine what works about psychological therapy for~     youth.~   "
35627|NCT03100266|"~     Probiotics for spinal inflammatory end-plate changes, so-called Modic changes, a randomised~     controlled study~      Modic changes are inflammatory end-plate changes primarily affecting the lower lumbar levels.~     They are associated with disc degeneration, disc herniation and age, and are only seen on~     magnetic resonance imaging of the lumbar spine, not on X-ray. Three different types of Modic~     changes have been described, type 1, 2 and 3, the latter being rare [5]. It has been shown~     that type 1, but not type 2, is associated with more intense low back pain (LBP) and worse~     LBP outcome including a lower rate of return to work [7]. In addition, more inflammatory~     cells have been identified in this type of structural abnormality [25]. Modic changes may~     affect up to 20% of the general population and more than the double proportion in clinical~     populations, type 1 and 2 being about equally represented [6]. The investigators have~     estimated that at least 5,000 of the patients, who are referred to secondary health care in~     Denmark for LBP per year, will suffer from type 1 Modic changes.~      Based on a hypothesis of infection as the cause of Modic changes, a randomised clinical trial~     with one year follow-up has been performed [16]. This trial documented significant effect of~     long-term (100 days) broad-spectrum antibiotic treatment (amoxicillin/ clavulanic acid) in~     patients with type 1 Modic changes. However, infection in Modic changes has not been~     documented convincingly in this or in other studies, and almost all of the treatment effect~     occurred after the antibiotic treatment was stopped. As yet, the study has not been~     replicated. The investigators hypothesize that the treatment effect may have been caused by~     an effect on the gut microbiom possibly explaining the delay of the effect.~      Probiotics have been shown to influence interleukins in patients with inflammatory conditions~     and in healthy volunteers [32, 36, 37].~      The investigators are therefore performing a randomised trial to study the clinical effect of~     probiotics on type 1 Modic changes as well as the effect on interleukin levels. The trial is~     designed as a randomised, clinical, double blind, placebo-controlled trial taking place at~     the Spine Center, Silkeborg Regional Hospital. Power calculation was based on a smaller~     treatment effect than the effect found in the study above and resulted in the requirement of~     including 94 patients. One-year follow-up is planned.~      The investigators use lactobacillus rhamnosus GG (Dicoflor®) for the trial, as this strain~     has been used in several clinical studies. The dietary supplement has been shown to influence~     relevant interleukins significantly, and it has been proven to be stable in action and safe,~     also in pregnancy.~      A positive result of such a trial may have significant consequences. The perspective of using~     probiotics instead of antibiotics in this common disorder is very attractive. At the time~     being, many type 1 Modic patients in Denmark and other western countries are treated with~     antibiotics. This is of great concern because of side effects and possible drug resistance~     development of bacteria.~      The Technology Transfer Office of Aarhus University is involved.~   "
35628|NCT03100253|"~     To compare the efficacy of switching to a different molecular target (from TNF to IL6) versus~     cycling to a second TNF inhibitor in patients with active RA, who have not adequately~     responded to a previous treatment with a first anti-TNF.~   "
35629|NCT03100240|"~     NF-κB pathway activation-induced endometrial insulin resistance was one of the causes of~     infertility patients with PCOS and insulin resistance whose endometrial receptivity is~     declined .The investigators' previous findings indicated that the use of modified utral-long~     protocols ( GnRH-a was used twice in mid-luteal phaes) can improve clinical outcomes by~     improving endometrial receptivity in patients with PCOS , but the mechanism was not clear.~     Previous research also found that GnRH-a reduced the activity of NF-κB pathway in endometrial~     stromal cells and depended the dose and time.Thus, The investigators' subject will try to~     applicate GnRH-a to explore the influence of NF-κB pathway activity 、the state of insulin~     resistance and embryo implantation rate ;then we will investgate GnRH-a whether reduce NF-κB~     pathway activity-induced insulin resistance and ultimately improve endometrial receptivity by~     using GnRH-a in infertility patients with PCOS and insulin resistance.The investigators'~     research attempt to provide ideas for seeking inflammatory medication target in assisted~     reproductive technology in patients with PCOS by exploring the immune mechanism of GnRHa on~     improving the endometrial receptivity .~   "
35630|NCT03100227|"~     Epilepsy is the most common chronic neurological disorder in the world, affecting more than~     50 million people worldwide.~      Approximately 35% of patients with epilepsy are refractory to all available antiepileptic~     drugs. Focal Hypometabolism on interictal [18F]-FDG PET is a hallmark of the Seizure Onset~     Zone as well as surrounding areas. Using [18F]-FDG PET is thus particularly useful to~     determine the seizure onset zone of epileptic patients and thus to guide surgical treatment~     when antiepileptic drugs fail.~      Interpretation of PET images primarily relies on standard visual analysis, but statistical~     analysis, with the widely used Statistical Parametric Mapping (SPM) software improves the~     diagnostic yield of PET. Over the past years, some authors have thus reported that the use of~     SPM can result in greater sensitivity and specificity of PET imaging in patients with partial~     epilepsy.~      In order to perform statistical analysis of PET images to compare brain metabolism of~     epileptic patients and healthy controls, it is necessary to collect a normative database of~     [18F]-FDG PET images in healthy controls.~      The purpose of this study is (i) collect a normative database of [18F]-FDG PET images in~     healthy adults controls to evaluate rigorously the diagnostic value of multimodal imaging for~     non-invasive localization of the EZ and (ii) to evaluate the test-retest reliability of~     [18F]-FDG PET scanning.~   "
35706|NCT03099239|"~     The purpose of this Phase 1 study is to determine the safety of one, two, and three~     intravenous infusions of human umbilical cord tissue-derived mesenchymal stromal cells~     (hCT-MSC), administered every two months, in children with autism spectrum disorder (ASD).~   "
35707|NCT03099226|"~     The purpose of this study was to characterise the plasma and urine pharmacokinetic profile of~     Etamicastat (BIA 5-453) and its metabolites after three multiple rising dose regimens of~     Etamicastat (BIA 5-453).~   "
35631|NCT03100214|"~     Studies demonstrate that exercise increases the maximal oxygen uptake, peak oxygen~     consumption, reduce effort-induced lactic acid production, and increase skeletal muscle~     oxidative capacity, as well as psychological aspects such as increased self-esteem and~     improvement of the quality of life.~      In the literature there is only one study involving rehabilitation in hospitalized pediatric~     patients with cystic fibrosis. Thus, more information on in-hospital rehabilitation is~     required in adult cystic fibrosis patients.~      The present study aims to evaluate the effects of an early rehabilitation program, based on~     aerobic training and muscle strength training, in adolescent and adult patients with cystic~     fibrosis hospitalized at Hospital de Clinicas de Porto Alegre for exacerbation of lung~     disease.~   "
35632|NCT03100201|"~     In this study, patients with upper arm fracture will receive an additive robotic-assisted~     training using the Armeo®Spring robot for three weeks on the injured arm in addition to~     conventional physio- and occupational therapy. The supportive treatment and execution of~     specific exercises on the Armeo®Spring should lead to improved recovery of function and~     mobility of the upper arm compared to conservatively treated patients.~   "
35633|NCT03100188|"~     This study aims to use modified peritoneal dialysis prescriptions to achieve adequate~     clearance and volume removal while decreasing the number of exchanges or time spent on~     dialysis, evaluating maintenance of residual renal function, and improving quality of life.~   "
35634|NCT03100175|"~     Frailty, one of geriatric syndromes, is considered a major obstacle for recovery from~     physiological stress. Such stress is imposed on patients with cancer by virtue of the disease~     itself but even more so by the treatment. Moreover, malignancy and chemotherapy both cause~     accelerated loss of muscle mass, deconditioning, frailty and negative outcomes. Several~     studies showed that chemotherapy accelerates ageing.~      Muscle mass reserve was found to be a major predictor of outcomes in patients treated with~     chemotherapy. Recently, several studies suggest that active muscle strength training during~     chemotherapy may decrease side effects, improves the ability to deliver intended doses of~     treatment and may even affect oncological outcomes.~      In the proposed study we intend to assess the contribution of physical training to the~     well-being of chemotherapy treated older patients, assessed by molecular and physiological~     parameters.~      We intend to recruit lymphoma patients above age of 70 and prospectively and randomly assign~     them to the intervention group (strength, aerobic and balance training during the~     chemotherapy) and control group (standard care with no special emphasis on physical activity~     during the treatment).~      We will measure clinical outcomes such as treatment tolerance and effects as well as~     physiological outcomes (muscle strength and mass, elements activities of daily living) and~     laboratory markers of ageing such as DNA methylation, INK 4a expression, telomere length and~     serum levels of inteleukin 6, CRP among others.~      Our hypothesis is that physical training will improve patients' ability to complete the~     treatment with fewer side effects, will provide them with better daily functioning and better~     muscle strength/function. We also hypothesize that the ageing process, as shown by laboratory~     senescence markers, will be attenuated in the intervention group.~   "
35635|NCT03100162|"~     Effect of oral supplementation with probiotics on cardiometabolic risk factors, microflora~     and intestinal epithelial permeability, mineral content and lifestyle in obese women with~     postmenopausal metabolic syndrome: double-blind, randomized clinical trial.~   "
35636|NCT03100149|"~     This multicenter, randomized, double-blind, placebo-controlled, Phase 2 study will evaluate~     the efficacy of intravenous RO7046015 versus placebo over 52 weeks in participants with early~     Parkinson's Disease (PD) who are untreated or treated with monoamine oxidase B (MAO-B)~     inhibitors since baseline. The study will consist of 2 parts: a 52-week, double-blind,~     placebo-controlled treatment period (Part 1) after which eligible participants will continue~     into an all-participants-on-treatment blinded dose extension for an additional 52 weeks (Part~     2).~   "
35637|NCT03100136|"~     This is a study measuring the binding kinetics and test-retest characteristics of a~     subpharmacological dose of [11C]PF-06809247 Monoacylglycerol lipase (MAGL) Positron Emission~     Tomography (PET) tracer in healthy adult subjects.~   "
35638|NCT03100123|"~     The APPLE pilot trial is a feasibility study that is a multicentre, open-label, randomized~     controlled trial. Pregnant women with antiphospholipid syndrome (APS) and a history of late~     (≥10 weeks gestation) or recurrent early (2 <10 weeks) pregnancy loss will be recruited.~      Eligible and consenting subjects will be assigned to one of two study arms: open-label~     low-molecular-weight heparin (LMWH) prophylaxis until 37 weeks gestation AND low-dose aspirin~     (ASA) daily until delivery, or open-label low-dose aspirin daily from randomization until~     delivery.~   "
35639|NCT03100110|"~     Individuals suffering from tetraplegia as a result of cervical spinal cord injury, brainstem~     stroke, or amyotrophic lateral sclerosis (ALS) cannot independently perform tasks of daily~     living. In many cases, these conditions do not have effective therapies and the only~     intervention is the provision of assistive devices to increase independence and quality of~     life. However, currently available devices suffer from usability issues and are limiting for~     both the patient and caregiver. One of the most progressive alternative strategies for~     assistive devices is the use of brain-computer interface (BCI) technology to translate~     intention signals directly from sensors in the brain into computer or device action.~     Preclinical primate research and recent human clinical pilot studies have demonstrated~     success in restoring function to disabled individuals using sensors implanted directly in~     motor regions of the brain. Other preclinical primate research has demonstrated effective~     intention translation from sensors implemented in cognitive regions of the brain and that~     this information complements information from the motor regions. The current proposal seeks~     to build on these studies and to test the safety aspects related to implanting two sensors,~     each a microelectrode array, into both the motor and cognitive regions of the brain in motor~     impaired humans. Secondary objectives include feasibility evaluation of the complementary~     sensors in their ability to support effective assistive communication.~   "
35640|NCT03100097|"~     The objective of this study is to evaluate sixty male and non-pregnant female patients~     diagnosed with acute moderate to severe low back pain with the onset of symptoms within 30~     days. To evaluate functional improvement following a 4-week use of an in-elastic lumbar~     sacral orthosis (LSO) as a treatment modality for acute low back pain.~   "
35641|NCT03100084|"~     The PREPPeD study proposes that predelivery placenta-derived maternal circulating biomarkers~     reflect placental health, capacity and ageing, and can help predict onset and complications~     of delivery both in complicated pregnancies as well as in clinically uncomplicated~     term/post-term pregnancies.~   "
35642|NCT03100071|"~     Cancer patients with Central Venous Catheter (CVC) Associated Deep Vein Thrombosis (DVT) will~     be treated with Low Molecular Weight Heparin (LMWH) and apixaban. Study duration is 12 weeks.~   "
35643|NCT03100058|"~     This is a dose-finding study to evaluate the change in weight after 24 weeks treatment with 8~     different doses of LIK066 compared to placebo in obese or overweight adults, followed by 24~     weeks treatment with 2 doses of LIK066 and placebo.~   "
35646|NCT03100019|"~     Objectives: Resveratrol, a non-flavonoid polyphenol, has been found to consistently modulate~     cerebral blood flow (CBF) following oral supplementation. Although, this has not resulted in~     subsequent predicted benefits to cognitive performance in young healthy populations. However,~     it is argued that those who suffer a reduction in CBF and cognition, such as aging~     populations, may benefit more from resveratrol administration.~      Hypothesis: The current investigation aimed to employ a mild hypoxia as an experimental model~     of aging in a young healthy population, to assess if resveratrol can attenuate the deficits~     elicited by the reduction in oxygen supply. It was hypothesized resveratrol would module CBF,~     to provide a more efficient supply of oxygen to overcome any associated decreases to~     performance caused by the hypoxic model.~      Design: This repeated measures, double blind, placebo controlled, balanced design assessed~     the cognitive and CBF effects of resveratrol in hypoxia (equivalent to ~2000m above sea~     level) and normoxia (sea level).~      Methods: 24 participants arrived fully fasted (except water) for 12 hrs before completing a~     baseline measure of a cognitive task battery, and taking the treatment for the day. Following~     a 45 min absorption period, participants completed 3 full repetitions of the cognitive test~     battery and, if appropriate, the oxygen level was altered. Changes in CBF were measured by~     near-infrared spectroscopy throughout the full testing session.~   "
35647|NCT03100006|"~     The purpose of this study is to characterize the safety and tolerability, identify a~     recommended dose for expansion (RDE) / recommended phase II dose (RP2D), pharmacodynamics,~     and antitumor activity of Oregovomab vaccination in combination with Nivolumab as a novel~     combinatorial immunotherapeutic strategy in in female patients with recurrent epithelial~     ovarian cancer (EOC) who progressed after two or more prior lines of cytotoxic chemotherapy.~   "
35648|NCT03099993|"~     In France, Cerebral Palsy (CP) affects 1 in 450 births. It results from lesions of the brain,~     before, during, or shortly after birth. These non-progressive lesions cause muscle~     impairments, responsible for activity limitations. These muscle impairments include muscle~     stiffness, and muscle weakness. Children with Unilateral CP (UCP) have these impairments on~     only one side of the body. To compensate for activity limitations with their impaired arm,~     these children over-use their non-impaired arm. The objective of constraint-induced therapy~     (CIT) is to minimize this asymmetry which deteriorates mobility on the impaired side, by~     forcing the child to only use its impaired arm several hours a day during several weeks of~     therapy. It is known using clinical tests that this therapy improves the overall motor~     function of the impaired arm. However, the underlying mechanisms are yet unknown. An~     understanding of these mechanisms would suggest ways to maximize the effectiveness of this~     therapy, which requires a significant commitment from the child and its family. The~     investigaors propose in this project a quantitative and objective evaluation of the effect of~     CIT on the movements of the impaired arm of children with UCP. The investogators focus their~     analysis on muscle activation, to assess which aspect of muscle impairments is modified by~     CIT. To this end, the investigators will use sensors identical to those already used in~     clinics for the Quantified Gait Analysis of children with CP, recognized since 2006 by the~     Haute Autorité de Santé as providing key supplementary data in the evaluation of complex gait~     disorders. Results from this study will provide leads to optimize CIT. Some children could~     for example benefit from CIT paired with treatments to reduce muscle stiffness or to~     strengthen muscles~   "
35649|NCT03099980|"~     This is a pilot study in which the the safety and feasibility of secukinumab in HS patients~     as well as information about the effect size will be determined in order to inform a future~     larger randomized control trial with an active comparator.~   "
35650|NCT03099967|"~     To examine retrospectively whether transcatheter closure of the interatrial septum leads to~     myocardial injury and to determine the mechanism.~   "
35651|NCT03099954|"~     Measure pulse wave velocity stability in relation to time of day, day of the week, physical~     activity, sleep quality, stress levels and blood pressure.~   "
35652|NCT03099941|"~     Abstract. Insufficient motor control mechanism of transversus abdominus and multifidus~     muscles is the most important cause of the chronic nonspecific low back pain (CNLBP).~     Recently, applications sre developed that generates audio and vibrant stimuli in response to~     anteroposterior and mediolateral rotations and can be adapted according to subject-specific~     movement sensitivity.~      Objective. The objective of this study was to compare effects of a biofeedback application~     that is alternative to physiotherapist feedback in core stabilization training of patients~     with chronic nonspecific low back pain.~      Design. This study was a parallel group randomized controlled trial with outcome assessment.~      Patients. The participants were 38 patients with chronic (≥12 weeks) nonspecific low back~     pain.~      Interventions. Patients were randomly assigned to receive either physiotherapist feedback or~     Perfect Practice (Level Belt Pro Inc.) biofeedback. Patients in both groups received 12~     sessions, 30 minutes of three weekly graded functional core education trial.~      Measurements. Primary outcome measures were muscle strength (transversus abdominus and~     multifidus) pain intensity (Visual Analog Scale) and functional level (Revised Oswestry~     Disability Index); secondary outcomes were flexibility (modified Schober test), range of~     motion (universal goniometer), proprioception (Active Reposition Test), patient beliefs (Fear~     Avoidance Beliefs Questionnaire), psychological status (Beck Depression Index), and quality~     of life(36 Item Short-Form Health Survey questionnaire [SF-36]).~      Limitations. Outcome measures for muscle strength did not include objective assesment.~      Keywords. Chronic low back, core stabilization training, biofeedback, pain, function~   "
35653|NCT03099928|"~     Specific Aim #1 (Qualitative Research): To identify, through qualitative research, deficits~     in positive affect and associated barriers to completing health behaviors in type 2 DM~     patients.~      Hypothesis: Patients will be able to complete the structured interview, providing information~     about their own positive emotional states, identifying strategies to enhance positive~     emotions, linking the presence of positive emotions to better adherence to health-related~     behaviors, and identifying additional barriers to completing such behaviors.~      Specific Aim #2 (Creation of intervention): To use the data gathered from qualitative and~     quantitative measures to create a positive psychology-based intervention~      Hypothesis: Using the information provided in this trial, the investigators will be able to~     create an intervention, composed of several positive psychology exercises, that is~     well-matched with a diabetic population and is targeted to the enhancement adherence to~     health-related behaviors in this population. This intervention will then be ready for next~     stage testing.~   "
35654|NCT03099915|"~     Objective: Identify modifiable factors that may affect asthma control and the use of~     emergency room to define customized interventions for the management of asthma prior to~     emergency room.~      Emergency department attendance is always a sign of poor balance or control of asthma. In~     spite of a decrease in the number of deaths that has been halved in 20 years and~     hospitalization due to asthmatic disease, the use of emergency center for this disease has~     not decreased. We now know that the passage through emergencies and hospitalization for~     aggravation of asthma is in itself a factor of mortality. Acting on the determinants of poor~     balance or control of asthma is essential to further reduce the mortality and morbidity of~     asthma.~   "
35655|NCT03099902|"~     This study will investigate the interaction between GSTP1 / TNFa polymorphisms and passive~     smoking in children with asthma/wheezing. Contemporary second hand-smoke exposure will be~     confirmed by laboratory testing.~   "
35656|NCT03099889|"~     The WHISH-2-Prevent Heart Failure (HF) study is an ancillary study to the Women's Health~     Initiative Strong and Healthy (WHISH) exercise pragmatic trial. The WHISH-2-Prevent HF trial~     examines the intervention effect of physical activity (PA) on both incident HF and HF burden~     (recurrent HF and CVD death in those with HF) in a cost effective manner in elderly women. In~     addition, it will allow a dose-finding analysis to better understand the type, intensity and~     frequency of PA that leads to a reduced risk and burden of HF. The focus of the parent WHISH~     trial is on atherosclerotic cardiovascular disease and not heart failure.~   "
35657|NCT03099876|"~     This study compared efficacy and safety of basic triple therapy according to treatment~     period. This study evaluated Effect of CYP2C19 genetic polymorphisms on the efficacy~   "
35658|NCT03099863|"~     Postoperative urinary tract infections (UTIs) affect 20-30% of patients undergoing elective~     gynecologic surgery and have a significant socioeconomic impact and cost. Preoperative~     antibiotics, sterile operating techniques, postoperative antibiotic and non-antibiotic~     medical therapies have been utilized to attempt to decrease this rate with little~     improvement. Utilization of an intraoperative antibiotic cystoscopic irrigant may decrease~     postoperative UTIs. The investigators have designed a prospective randomized controlled study~     to evaluate the effectiveness of an antibiotic cystoscopic fluid in preventing postoperative~     urinary tract infections in women undergoing elective pelvic floor surgery with cystoscopy.~   "
35659|NCT03099850|"~     The Coordinating and Data Management Center (CDMC) at MD Anderson Cancer will be responsible~     for the coordination and data management for the Prospective Evaluation of Chronic~     Pancreatitis for Epidemiologic and Translational Studies (PROCCEED) Study, which is part of~     the NIH U01 funded Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic~     Cancer (CPDPC). No patient enrollment will occur at MDACC. All patient recruitment will occur~     at external sites that are a part of the CPDPC. The data management systems, auditing, and~     monitoring effort are supported by the MD Anderson Cancer Center Clinical Research Support~     Center (CRSC).~   "
35660|NCT03099837|"~     This is a population-based study to obtain data for the evaluation of current used~     recommendations for weight gain during pregnancy released by IOM (2007) and investigate the~     association between maternal diet and the health outcomes of mother and offspring.~   "
35661|NCT03099824|"~     The purpose of the phase 1, GTO-003 clinical study is to determine the safety, tolerability~     and pharmacokinetics of a single dose of a new drug called GC4711 when given as an oral~     tablet. This study will compare capsules containing a liquid suspension of GC4711 when given~     orally to a similar drug called GC4419 which will be given as an intravenous infusion. This~     study will also assess the effect of food on GC4711.~   "
35662|NCT03099811|"~     Secondhand smoke exposure (SHSe) is one of the most common and potentially modifiable~     environmental triggers for asthma. Financial incentivization may serve as an effective~     modality to reduce SHSe among pediatric asthmatics with potential down-stream benefits on~     improved asthma control and subsequent reduced healthcare utilization. This study plans on~     testing the feasibility and effectiveness of financial incentives to decrease SHSe, derived~     from primary caregivers and a member of their social network, of children with persistent~     asthma.~   "
35663|NCT03099798|"~     OBJECTIVE:~      To determine the quality of life (QOL) and clinical outcome after conservative therapy,~     embolization (proximal versus distal) or surgery in patients with traumatic splenic injury.~     Secondary aims: (I) to examine therapy-related complications, (II) to establish the necessity~     of additional therapies, (III) the assessment of splenic function related to splenic~     morphology (MR imaging) after embolization and (IV) to find the prognostic factors for~     failure of non-operative management (NOM) in patients with splenic injuries. Finally, with~     the acquired data from this study a patient-oriented protocol will be provided for the~     management of traumatic splenic injury.~      HYPOTHESIS:~      The investigators expect that NOM is superior to surgery with regard to QOL, clinical outcome~     and splenic function. Embolization will need more additional therapies. Splenic morphology is~     related to splenic immune function. Expected prognostic factors are age above 40, ISS >25 and~     a splenic injury grade of 3 or higher.~      STUDY DESIGN:~      A combination of a retrospective and a prospective multicentre cohort study. This protocol~     involves the prospective part of the study.~      STUDY POPULATION/DATASET:~      Patients who enter the participating hospitals between March 2017 and July 2018 with splenic~     injury will be asked to participate. The follow-up period will be one year with regard to~     QOL, clinical symptoms and imaging.~      INTERVENTION:~      All patients will complete a number of questionnaires at different time points. The patients~     who were treated with splenic artery embolization (SAE) will undergo an MRI one month and one~     year after treatment.~      OUTCOME MEASURES:~      Primary outcome is QOL. Secondary outcomes are clinical symptoms and imaging.~      SAMPLE SIZE:~      Approximately 100 patients will be included per year during the inclusion phase.~      DATA ANALYSIS:~      With regard to the prospective data linear modelling will be performed.~      COLLABORATION/CONNECTION:~      Tilburg University, Erasmus medical center Rotterdam, Maasstad hospital Rotterdam, Albert~     Schweitzer hospital Dordrecht, Amphia hospital Breda.~      TIME SCHEDULE:~      Year 1: literature search and conducting the retrospective study and analyses. Years 1-3:~     inclusion prospective study and follow-up of patients. Year 4: finishing follow-up data~     collection and analysing.~   "
35664|NCT03099785|"~     The objective of this study is to evaluate the safety and efficacy Rifamycin SV-MMX® 600 mg~     tablets for patients with diarrhoea-predominant irritable bowel syndrome when administered~     two to three times daily.~   "
35708|NCT03099213|"~     Primary Objective:~      To document the tolerability of patients receiving study medication at 12-week of therapy in~     terms of the scoring system assessed by the investigator.~      Secondary Objectives:~        -  To document drug safety at 12-week of treatment in terms of number of Adverse Drug~          Reaction or Serious Adverse Drug Reaction reported.~        -  To describe the population treated as per the HOPE study indication in current clinical~          practice (demographics, cardiovascular risk-factors at treatment initiation, concomitant~          treatments patterns).~   "
37302|NCT03078374|"~     The purpose of this study is to obtain single-center safety and feasibility data on patients~     managed with reduced anti-coagulation, and the incidence of thrombotic and bleeding adverse~     events associated with the HeartMate 3 LVAS therapy.~   "
35665|NCT03099772|"~     Generalized anxiety disorder (GAD) is a condition characterized by chronic and excessive~     worry and anxiety. Over the past 15 years, the investigators have developed a~     cognitive-behavioural treatment that leads to the remission of GAD in approximately 60% to~     75% of affected individuals. Although these numbers are encouraging, there remain a~     considerable proportion of patients who do not fully benefit from treatment. With the goal of~     improving treatment efficacy, the investigators have recently carried out a series of related~     studies on the way individuals with GAD and high worriers process uncertain or ambiguous~     information from their environment. The findings show that these individuals display biases~     in attention for, and appraisal of, uncertain or ambiguous information. Specifically,~     individuals with GAD and high worriers preferentially allocate their attention to~     uncertainty-related stimuli and appraise ambiguous information in a threatening manner. In~     this study, the investigators examine the impact of these information processing biases,~     measured at intake, on the efficacy of cognitive-behavioural treatment for GAD. The~     investigators also examine the impact of residual information processing biases, measured at~     posttreatment, on the maintenance of treatment gains over 18 months following treatment. The~     main hypotheses are (1) that high levels of pretreatment biases will predict poorer outcomes~     immediately following therapy, and (2) that high levels of posttreatment biases will predict~     relapse during the 18 months following therapy. If, as expected, information processing~     biases predict poor short- and long-term treatment outcomes for individuals with GAD, the~     investigators will expand the treatment to integrate strategies that directly target these~     biases in order to increase its efficacy.~   "
35666|NCT03099759|"~     Analyze the amount of change in blood serum Vitamin D levels in patients of 3 different~     dosing groups and how their levels change over a 3 month period of time.~   "
35667|NCT03099746|"~     Each year, millions of Americans are admitted to an intensive care unit (ICU). For more than~     half of them, ICU admission initiates a cascade of decisions about treatment and end-of-life~     care.This is particularly the case for patients with chronic critical illness, a~     life-limiting syndrome. Most (74%-82%) ICU patients who require mechanical ventilation have~     transient or persistent cognitive impairment that precludes them from making their own~     healthcare decisions. Among ICU patients, the chronically critically ill (CCI) are at highest~     risk for cognitive impairment and thus require a surrogate decision maker (SDM), usually a~     family member. SDMs for the critically ill often describe high states of psychological stress~     associated with the uncertainty of the patient's condition and their decision making role.~      The purpose of this study is to test the effectiveness of two decision support interventions~     for end-of-life care delivered to SDMs of CCI patients. This will be the first study to test~     interventions tailored to the unique needs of the SDMs of CCI patients delivered using an~     interactive avatar based format.~   "
35668|NCT03099733|"~     This will be a prospective study of the implementation of a real-time assessment and~     intervention of a text messaging tool in mild traumatic brain injury (mTBI) patients~     post-discharge from the emergency department.~   "
35669|NCT03099720|"~     Following a hysterectomy, women tend to experience high levels of pain, and many require~     strong pain killers after the procedure. Ropivacaine is a local anaesthetic drug (injectable~     numbing medication) which works by blocking pain signals. The aim of this study is to find~     out whether injections of ropivacaine during surgery can help provide effective pain relief~     after surgery.Women aged between 45 and 70 who are having a vaginal hysterectomy can~     participate in the trial. Participants are randomly allocated to one of two groups. Those in~     the first group are given injections of ropivacaine at the site of the wound and in the~     peritoneum (space in the body that holds the organs in the abdomen) and those in the second~     group are given injections of a saline fluid in the same places that offers no pain relief~     before the end of their surgery. Participants in both groups are then regularly asked to rate~     their pain levels up to 24 hours after surgery. In addition, the pain killers they receive~     and length of hospital stay are recorded. There is a chance that the participants who receive~     the ropivacaine will benefit from lower pain levels after surgery. There are no notable risks~     of participating.~   "
35670|NCT03099707|"~     This study will evaluate the feasibility and acceptability of the Treatment Ambassador~     program - a peer-supported intervention targeting individuals living with HIV who have not~     started on treatment within at least 3 months of testing.~   "
35671|NCT03099694|"~     The investigators compared advantages and disadvantages of two forms of noninvasive~     respiratory support —noninvasive high-frequency oscillatory ventilation (nHFOV) or nasal~     continuous positive airway pressure (nCPAP) —as a primary mode of ventilation in premature~     infants with RDS．~   "
35672|NCT03099681|"~     Prospective Italian study aimed to provide a description of the population affected by~     Epithelioid Sarcoma (ES)~   "
35673|NCT03099668|"~     A randomised study of multidisciplinary care (MDT) versus routine care in patients with~     rheumatoid arthritis (RA). Patients with RA are randomised either to a single visit to a one~     Stop Arthritis Clinic' (OSAC) or to see their usual rheumatologists. Data are collected at~     the baseline visit, and again at subsequent clinic visits (approximately 3 and 6 months).~     Outcomes such as quality of life, disease activity, physical function, disease specific~     knowledge, coping and self efficacy are evaluated. Assessment of comorbidities and~     preventative care (cancer screening, vaccinations, cardiovascular risk assessment and~     optimisation) are also assessed between the 2 arms.~   "
35674|NCT03099655|"~     The purpose of this clinical study is to evaluate the safety and efficacy of the Attain~     Stability Quadripolar MRI SureScan Left Ventricular (LV) lead (Model 4798).~   "
35675|NCT03099642|"~     The aim of this study is to determine if emergency physician performed ultrasound-assisted~     lumbar puncture improves first-time success rates in a pediatric population. This will be~     done by comparison with current landmark-based approach to the procedure.~   "
35676|NCT03099629|"~     The purpose of this study is to investigate the effectiveness of inspiratory muscle training~     (IMT) on respiratory performance in patients with esophageal cancer during combined modality~     therapy.~   "
35709|NCT03099200|"~     The purpose of this study is to compare productivity (in terms of work or daily activity) and~     generic and disease-specific health-related quality of life of participants with HER2~     positive early breast cancer currently receiving adjuvant treatment (with chemotherapy and/or~     targeted HER2 therapy), with participants who have completed adjuvant parenteral therapy, and~     participants with HER2 positive metastatic breast cancer.~   "
35677|NCT03099616|"~     Complete recovery from anaesthesia is absolutely desirable in the obese patients to avoid~     postoperative airway, oxygen ventilation or sleep apnea related complications. Over the~     years, Desflurane has emerged as the anaesthetic agent of choice for maintenance of~     anaesthesia in obese patients for its efficient elimination profile and ability to facilitate~     early recovery from anaesthesia. Alternatively, Propofol is a commonly used intravenous~     anesthetic agent administered as a part of total intravenous anesthesia (TIVA) regimen.~     However, it is a lipid soluble drug and there are concerns that it may accumulate in obese~     patients due to their increased proportion of body fat Therefore, Propofol TIVA is likely to~     result in a prolonged duration of action and consequently, delayed emergence from anaesthesia~     and a protracted recovery time. A recent advance in the delivery of Propofol to the patient~     is the development of computer-controlled anesthesia delivery systems. These devices deliver~     Propofol based on feedback from patient's frontal cortex electrical activity as determined by~     monitoring bispectral index (BIS). Evaluation of anesthesia delivery by these systems has~     shown that Propofol and maintain depth of anesthesia with far more precision as compared to~     manual/simple infusion administration. This, in turn, holds promise that recovery from~     Propofol anaesthesia can also be favourable in the obese patients. An indigenously developed~     computer-controlled anesthesia delivery sytem is the closed loop anaesthesia delivery system~     (CLADS), which has been extensively evaluated in patients belonging to different surgical~     settings. The evidence generated with Propofol anaesthesia delivered by CLADS has shown~     significant improvement in recovery outcome.The performance of CLADS has not yet been~     evaluated in obese surgical patients. We hypothesise that in the obese patients undergoing~     bariatric surgery, automated delivery of Propofol using CLADS would allow precision control~     of anaesthesia depth, intra-operative haemodynamics, and rapid recovery from anaesthesia. We~     plan to conduct a randomised controlled investigation to compare patient recovery profile~     following Desflurane anaesthesia versus CLADS empowered Propofol anaesthesia.~   "
35678|NCT03099603|"~     This is a randomized, double blind, single center, ascending single dose study to evaluate~     the safety, tolerability, and PK of HTD1801.~   "
35679|NCT03099590|"~     Participants will enroll in a 14-week study (2 weeks of baseline, 8 weeks of treatment, and 4~     weeks of follow-up) investigating the impact that Alkontrol-herbal (Isoflavone; Kudzu) has on~     alcohol intake in a population seeking treatment for an alcohol use disorder.~   "
35680|NCT03099577|"~     The goal of this study is to find the maximum tolerable dose of radiation that can be~     delivered combined with chemotherapy (carboplatin & paclitaxel) in patients with stage III~     non-small cell lung cancer (NSCLC).~   "
35681|NCT03099564|"~     This is an open-label multi-center trial designed to evaluate the efficacy as well as the~     safety of combining pembrolizumab with Yttrium-90 (Y90) radioembolization in subjects with~     poor prognosis (high risk) HCC not eligible for liver transplant or surgical resection with~     well compensated liver function. Treatment will consist of pembrolizumab 200mg IV every 3~     weeks in conjunction with Y90 radioembolization performed one week after the first dose of~     pembrolizumab. If bilobar disease is present, a second Y90 radioembolization will be~     performed no later than 4 weeks after the first procedure to the contralateral hepatic lobe.~   "
35682|NCT03099551|"~     The aim of the present study was to evaluate the efficacy of two different toothbrushes~     (manual and sonic) on plaque control~   "
35683|NCT03099538|"~     Recently, Interleukin (IL)-17 has been identified as a key driver of chronic inflammation in~     Bullous Pemphigoid (BP). Ixekizumab is a recombinant high-affinity fully human monoclonal~     antibody that targets IL-17A Immunoglobulin gamma-1 (IgG1)/kappa-class. The purpose of this~     study is to determine the effect of Ixekizumab on BP patients.~   "
35684|NCT03099525|"~     The objectives of this single center, prospective, non-interventional cohort is to understand~     patient characteristics, general treatment patterns, effectiveness/safety of conventional~     disease modifying antirheumatic drug (DMARD) and biologic DMARD treatments in rheumatoid~     arthritis patients with ILD in the real-world setting~   "
35685|NCT03099512|"~     The purpose of this study is to investigate the effects of Short Foot Exercises on pain,~     biomechanical characteristics and functionality of lower extremity in patients with~     patellofemoral pain.~   "
35686|NCT03099499|"~     ONC201 is a small molecule which selectively targets the G protein-coupled receptor DRD2.~     Downstream of target engagement, ONC201 activates the integrated stress response (ISR) in~     tumor cell leading to inactivation of Akt and extracellular signal-regulated kinase (ERK)~     signaling as well as induction of the TRAIL pathway. ONC201 also inhibits dopamine receptor 2~     (DRD2), resulting in anti-tumor responses in preclinical models. Single agent ONC201 has been~     examined in open-label Phase I studies in patients with advanced, treatment refractory solid~     malignancies. Due to its differential anti-proliferative and pro-apoptotic response in tumor~     cells, treatment was overall well tolerated, and the recommended phase II dose of ONC201 was~     set at 625mg every three weeks. An additional dose-escalation phase I study (NCT02609230) is~     further evaluating weekly versus three week dosing in patients with advanced solid tumors and~     multiple myeloma. Preliminary data from these phase I studies suggests a possible clinical~     benefit in patients with advanced, chemo-refractory endometrial cancers, with at least one~     mixed response noted in a patient with clear cell histology.~      Hypothesis: Single agent ONC201 will demonstrate clinical benefit in women with recurrent or~     metastatic endometrial cancers, especially in those women with alterations in the~     Phosphoinositide 3 kinase (PI3K)/Akt/mammalian target of Rapamycin (mTOR) pathway.~   "
35687|NCT03099486|"~     This is a single arm open label pilot phase II trial of Regorafenib PO plus 5-FU/LV infusion~     in 15 mCRC patients who progressed on prior Regorafenib monotherapy as well as 5-FU~     containing chemotherapy combinations.The study will enroll mCRC patients with prior~     progression on standard multi-agent combination chemotherapy and progression on regorafenib~     monotherapy.~   "
35688|NCT03099473|"~     The purpose of the study is to testify the efficacy of treating trochlear nerve palsy with~     ocular electroacupuncture or ocular acupuncture, and to compare the efficacy between these~     two interventions.~   "
35689|NCT03099460|"~     The purpose of the study is to testify the efficacy of treating abducens nerve palsy with~     ocular electroacupuncture or ocular acupuncture, and to compare the efficacy between these~     two interventions.~   "
35690|NCT03099447|"~     The purpose of the study is to testify the efficacy of treating oculomotor nerve palsy with~     ocular electroacupuncture or ocular acupuncture, and to compare the efficacy between these~     two interventions.~   "
35691|NCT03099434|"~     This pilot study will be a clinical trial to test the feasibility and effectiveness of an~     educational intervention and a mobile health intervention in adults with end stage renal~     disease (ESRD) who have not yet identified a potential live donor.~   "
35692|NCT03099421|"~     The aim of this study is to investigate the safety and efficacy of prostatic artery~     embolization (PAE) for patients who refuse or are not eligible for surgery with~     moderate-severe lower urinary tract symptoms or indwelling catheter secondary to benign~     prostate obstruction due to benign prostatic hyperplasia.~   "
35694|NCT03099395|"~     Recurrent myocardial infarctions (reinfarctions) can be due to recurrence at the original~     treatment site, the presence of untreated lesions elsewhere, or in progressive lesions. There~     are scarce published data describing the localization (affected vessel/s) and severity~     (NSTE-ACS/STE-ACS) of reinfarction(s) compared to the index MI (e.g proportion of recurrent~     infarctions in the previously diseased vessel) in large unselected patient populations. If~     reinfarctions are generally more severe than index MI/recurrent MI(s), this might have~     implications for choice of treatment and treatment length.~      Moreover, data from unselected patient populations on the overall incidence pattern/rate of~     patients experiencing multiple reinfarctions is sparse. Patients who experience multiple~     ischemic events may be a subset of patients who are poor responders to therapy. There is also~     a possibility that patients with multiple events are less likely to have received~     evidence-based therapy such as coronary stenting, novel and more effective antithrombotics~     and modern lipid lowering treatment for the initial event. Poor adherence to secondary~     prevention measures (e.g. low compliance to medication and adherence to cardiac~     rehabilitation programs) may also increase the risk of recurrent events.~      Therefore identification of the baseline characteristics, including treatment decision~     strategies in the setting of a myocardial infarction, among such subjects may allow~     modifications of the clinical management strategy prior to the occurrence of subsequent~     ischemic events. Such modifications could include providing a more intensive or additional~     therapy in certain patient groups or find strategies to improve patient adherence and drug~     compliance.~      A patient with reinfarctions requires more hospitalizations, treatments, laboratory tests,~     and out-patient visits, resulting in overall increased costs. From the patient perspective,~     recurrent events result in higher mortality and worsened quality of life.~   "
35695|NCT03099382|"~     In this study, participants with advanced or metastatic squamous cell carcinoma of the~     esophagus that has progressed after first-line standard therapy will be randomized to receive~     either single agent SHR-1210 or the Investigator's choice of standard therapy with docetaxel~     or irinotecan. The primary study hypothesis is that treatment with SHR-1210 will prolong~     overall survival (OS) as compared to treatment with standard therapy.~   "
35696|NCT03099369|"~     Peripheral artery disease (PAD) is caused by blockages in the leg arteries. PAD limits~     patients' walking ability and quality of life. For patients with PAD, home exercise programs~     can improve walking ability and quality of life. In many patient populations, walking more~     than 5,000 steps a day is associated with better health. Currently, the benefit of walking~     more than 5,000 steps a day in patients with PAD has not been well studied.~      The purpose of this clinical trial is to compare two different home exercise programs in~     patients with PAD: walking at least 5,000 steps a day with the help of fitness monitors vs.~     walking 45 consecutive minutes for 3 to 5 days a week (a common exercise prescription for~     PAD). This study has the potential to demonstrate that, with the help of fitness monitors,~     walking at least 5,000 steps a day can improve walking ability and quality of life for~     patients with PAD.~   "
35697|NCT03099356|"~     This study will be a non-randomized pilot trial using Cyclophosphamide and Sirolimus for the~     treatment of metastatic differentiated thyroid cancer. Patients will be treated with~     Sirolimus 4 mg, PO, days 1-28 as well as Cyclophosphamide 100 mg, PO, days 1-5 and 15-19.~     Cycle length will be 28 days. Patients will be monitored closely for toxicity and undergo~     imaging to evaluate efficacy once every 2 cycles.~   "
35698|NCT03099343|"~     The proposed study will determine the effectiveness of a mobile application location-based~     tailored notification message system in helping hypertensive patients reduce dietary sodium~     intake and feel more confident in following a low sodium diet.~   "
35699|NCT03099330|"~     A study of TQ-B3139, inhibitor of ALK/C-Met tyrosine kinase, in patient with advanced cancer~   "
35700|NCT03099317|"~     The study aims to exam whether sinew acupuncture can relieve pain and symptoms of KOA and~     improve functional movement by Visual Analog Scale (VAS), Western Ontario and McMasters~     University Osteoarthritis Index (WOMAC), Timed up & Go Test (TUG) and 8-step Stair Climb Test~     (SCT) assessment, and Quality of life by Short Form-36 (SF-36). A randomized, sham~     acupuncture controlled, patient and assessor blinded, pilot study will be employed.~   "
35701|NCT03099304|"~     The purpose of this study is to examine the efficacy, safety, and tolerability of INCB018424~     cream in subjects with vitiligo.~   "
35702|NCT03099291|"~     The purpose of this study is to evaluate the safety, infectivity, and immunogenicity of a~     single dose of a recombinant live-attenuated respiratory syncytial virus (RSV) vaccine in~     RSV-seronegative infants and children 6 to 24 months of age.~      This study is a companion study to IMPAACT 2013.~   "
35703|NCT03099278|"~     Ezetimibe possesses pharmacophore features to inhibit NTCP, the receptor required for HBV and~     HDV hepatocyte entry that include two hydrophobes and one hydrogen bond acceptor. Therapy~     with Ezetimibe may lead to decline in hepatitis D virus levels. The aim of the study is to~     evaluate the utility of Ezetimibe in patients with chronic HDV infection~   "
35704|NCT03099265|"~     Surgical resection is the only potentially curative treatment for patients with pancreatic~     cancer. Patients with BRPC have tumors in close contact with the vasculature but not to the~     extent that resection is prohibited. Nonetheless, retrospective studies have shown that~     immediate resection in these patients is associated with an increased risk of positive~     margins, and a margin positive resection does not improve survival over that of patients with~     unresectable disease. Moreover, even in those patients where a successful resection is~     achieved, there is a high rate of early metastatic progression suggesting that~     micrometastatic disease is often present at diagnosis. Therefore neoadjuvant therapy is~     likely to improve outcomes in patients with BRPC to increase the likelihood of achieving a~     margin negative resection, provide early control of occult micrometastatic disease, and~     select those patients without systemic progression who would benefit from surgical resection.~   "
35705|NCT03099252|"~     Newborn infants have blood work procedures for newborn screening and bilirubin testing in~     their first days of life that cause pain, distress and physiological changes. Breastfeeding~     (BF), skin to skin care (SSC), or giving small amounts of sweet solutions (sucrose or~     glucose) with or without a pacifier, effectively and safely reduce pain and distress in~     newborn infants during painful procedures. However, studies of neonatal pain management~     practices in Ontario and throughout Canada demonstrate inconsistent use of these strategies.~     There is a clear need for developing and testing acceptable parent-targeted interventions,~     alongside health care provider-targeted knowledge translation (KT) interventions, to support~     parents' involvement in comforting their infants during painful procedures. To address this~     knowledge to action (KTA) gap, Denise Harrison's Be Sweet to Babies team developed the~     BSweet2Babies video, which demonstrates the effectiveness of BF, SSC, and sucrose during~     infant bloodwork and how parents can use and advocate for these pain management strategies.~      This study will evaluate the effectiveness of a parent-targeted and mediated KT strategy, the~     BSweet2Babies video, when shown to parents of newborns prior to newborn screening or~     bilirubin testing, on subsequent use of the three pain reduction strategies during the blood~     test.~      The target sample size for the study is 20 hospitals. Following consent, hospitals will be~     randomized to one of two groups: the intervention group (showing parents the BSweet2Babies~     video prior to their baby's newborn screening blood test) or the control group (no education~     or information provided). Hospitals in the intervention group will show all parents the 5~     minute BSweet2Babies video before newborn bloodwork. BORN Information System (BIS) data will~     subsequently be analyzed to evaluate the use of BF, SSC and sweet solutions.~      The investigators hypothesize that hospitals randomized to the BSweet2Babies video will have~     a higher rate of use of BF, SSC or sucrose as measured by the systematically collected Better~     Outcomes Registry & Network (BORN) Ontario pain data elements during newborn screening or~     bilirubin testing, compared to hospitals randomized to usual Health Care Provider~     (HCP)-targeted education.~   "
35711|NCT03099174|"~     For each dose finding cohorts (A, B, C and D):~      The primary objective of each dose finding cohort is to determine the maximum tolerated dose~     (MTD) / recommended phase II dose (RP2D) of xentuzumab in combination with abemaciclib with~     or without hormonal therapy (letrozole, anastrozole, fulvestrant). Dose limiting toxicities~     (DLT) will be assessed during the first treatment cycle to assess the MTD/RP2D.~      In case that no MTD is reached a RP2D dose will be determined taking into account safety data~     and other available information. This will be agreed with the Steering Committee.~      For each expansion cohorts (E and F):~      The objectives of the expansion cohorts are to assess the anti-tumour activity of xentuzumab~     in combination with abemaciclib in patients with non-small cell lung cancer (cohort E).~      Tentatively a cohort F may be opened to assess the anti-tumour activity of the triplet~     combination xentuzumab / abemaciclib and fulvestrant in a single-arm expansion group of~     patients with locally advanced / metastatic hormone receptor positive (HR+) breast cancer who~     have progressed following prior aromatase inhibitor therapy and prior CDK4/6 inhibitor~     treatment. Cohort F will only be opened if indicated by emerging data from ongoing clinical~     trials.~   "
35712|NCT03099161|"~     The purpose of this study is to evaluate the safety and preliminary efficacy of preladenant~     alone and in combination with pembrolizumab (pembro) in participants with advanced solid~     tumors that have not responded to prior therapy. This study will be done in 2 parts. Part 1~     will identify and confirm the recommended Phase II dose (RP2D) of preladenant when given~     alone or in combination with pembrolizumab. Part 2 of the study will determine the safety and~     efficacy of preladenant in combination with pembrolizumab at the RP2D in participants with~     select solid tumors .~   "
35713|NCT03099148|"~     The purposes of this study are to determine:~        -  If there are any differences in the amount of LY3337641 in the blood/body when it is~          taken in different formulations. A total of 3 different formulations of LY3337641 are~          being tested.~        -  How a high-fat meal affects the amount of LY3337641 in the blood/body.~        -  How safe and well tolerated LY3337641 is.~      The study has four periods. Individuals will participate in all four periods. Each period~     will include 4 overnight stays (5 days) in the Clinical Research Unit (CRU).~      This study is expected to last up to 8 weeks. This includes the initial screening period, the~     study or dosing period, and the follow up period.~   "
35714|NCT03099135|"~     The main purpose of this study is to evaluate the durability of Sustained virologic response~     (SVR) in participants who achieved SVR at last post-therapy visit of parent studies (LPVPS)~     with NCT Numbers NCT02569710 and NCT02765490.~   "
35715|NCT03099122|"~     Primary Objective:~      To investigate the efficacy of the standard dose of Thymoglobuline® induction therapy for~     preventing acute rejection (AR) after transplantation among recipients of Donated after~     Cardiac Death (DCD) kidney transplant.~      Secondary Objectives:~        -  To evaluate delayed graft function (DGF), graft and patient survival after kidney~          transplant.~        -  To evaluate adverse events of Thymoglobuline® throughout the study.~        -  To explore possible risk factors of AR and DGF in patients with DCD kidney transplant.~        -  To evaluate AR and DGF under different risk stratifications and explore an description~          optimal induction therapy regimen for recipients of DCD kidney transplant.~   "
35716|NCT03099109|"~     The purpose of this study is to evaluate the safety of the study drug known as LY3321367, an~     anti-T-cell immunoglobulin and mucin-domain domain-containing molecule-3 (TIM-3) antibody~     administered alone or in combination with LY3300054, an anti-programmed death ligand 1~     (PD-L1) antibody, in participants with advanced relapsed/refractory solid tumors.~   "
35717|NCT03099096|"~     This study is aimed to assess the correct real-world use of an autoinjector for the repeat~     self-administration of mepolizumab SC, so to improve subject / physician convenience and to~     enable repeat dose self injection themselves or via caregivers. This Phase III study will be~     an open-label, single-arm, repeat-dose, multi-centre study of mepolizumab liquid drug product~     in autoinjector (100 milligrams [mg]) administered subcutaneously (SC) every 4 weeks (3~     doses) in subjects with severe eosinophilic asthma. Subjects will receive 100 mg mepolizumab~     SC as a single injection that is self-administered in the thigh, abdomen or administered in~     the upper arm (caregiver only). Each subject will participate in the study for up to 18 weeks~     including pre-screening visit, a screening visit and a 12-week treatment period which~     concludes with end of study assessments (Visit 5) 4 weeks after the last dose of mepolizumab.~     Approximately 158 subjects will be enrolled in the study.~   "
35718|NCT03099083|"~     The objective of this non-interventional, observational study is to assess the effect of~     adalimumab on health-related quality of life in participants with Psoriasis in Korea.~   "
35719|NCT03099070|"~     This study will examine the influence of stress and fasting on headache activity.~     Participants will receive both a control and stress session and be randomized to either~     fasting or not fasting for the visits.~   "
35720|NCT03099057|"~     Develop a prospective register assessing the short- and long-term complications of patients~     undergoing interventional rhythm~   "
35721|NCT03099044|"~     The purpose of this pilot study is to determine the effects of a Single and Double Dose of~     Fermented Dairy Beverage on immune health and inflammatory status in healthy adults~     undergoing stressful exercise.~   "
35722|NCT03099031|"~     The purpose of this study is to validate the Ottawa score (risk of thromboembolic~     recurrences) in cancer patients with thromboembolic disease treated with tinzaparin~     (Innohep®)~   "
35723|NCT03099018|"~     Group A streptococcal (GAS) pharyngitis in children represents a frequent diagnostic~     challenge in pediatric emergency departments, since isolated signs and clinical prediction~     rules are insufficient to accurately discriminate between GAS and non GAS infections. Rapid~     antigen detection tests (RADTs) therefore remain essential, simple and rapid tools, allowing~     for rapid GAS identification and prompt antibiotic prescription. However, their sensitivity~     is not optimal. The aim of the present study is to test the accuracy of a new fluorescent~     immunoassay (Sofia Strep A FIA) using the optical technology for GAS detection in children~     3-15 years old with pharyngitis, compared to a standard RADT, using throat culture as the~     gold standard (or PCR for discrepant results, i.e. negative culture with any positive RADT).~   "
36263|NCT03091946|"~     The purpose of this study is to compare the glucose, insulin and subjective hunger responses~     elicited by oats with additional dried fruits, nuts and seeds soaked overnight in skim milk~     and consumed cold versus Cream of Rice cereal with additional dried fruits, nuts and seeds~     cooked just prior to its consumption.~   "
35724|NCT03099005|"~     Acute cannabis administration is reported to alleviate HIV neuropathic pain (HIV-NP), but~     there is limited knowledge about the effects of cannabis constituents (delta-9~     tetrahydrocannabinol/THC and cannabidiol/CBD), the consequences of long-term cannabis use,~     and the impact of cannabis on endocannabinoid (EC) function in people living with HIV- NP.~     Our objective is to address these three fundamental gaps in our knowledge by: 1) examining~     the acute effects of various CBD/THC products on HIV-NP, 2) utilizing a mHealth text~     messaging protocol, Individual Monitoring of Pain and Cannabis Taken (IMPACT) to monitor~     daily real-world cannabis use and changes in pain; and 3) studying the relationship between~     cannabinoids, EC biomarkers, and chronic neuropathic pain~   "
35725|NCT03098992|"~     There are many existing treatments of female stress urinary incontinence such as the use of~     adult absorbent pads and diapers, behavioral training, including bladder training, pelvic~     muscle exercises, biofeedback, urethral plugs, intravaginal prosthesis, electrical~     stimulation, periurethral injections, and reconstructive surgery. However, there is still a~     lack of effective minimally invasive treatment options that are independent of patient~     compliance.~      One emerging approach of minimally invasive SUI therapy is pelvic floor reinforcement using~     laser therapy.~      The primary objective of this post-marketing study is to confirm the effectiveness and safety~     of the FotonaSmooth® device in the treatment of stress urinary incontinence (SUI) in a large~     number of females using objective and subjective methods.~      Patients with stress incontinence will be assigned to two groups, an active group, where the~     Fotona Dynamis Er:YAG Laser System will be used, and a sham group where a very low laser~     setting will be used, and parameter presentations will be masked.~      Participants will be adult females, 18 years old and older with clinical and urodynamic~     diagnosis of Stress Urinary Incontinence,who have had no significant improvement in urinary~     incontinence from at least one previous conservative treatment, such as behavioral measures,~     pelvic floor muscle training or the use of absorbent pads~   "
35726|NCT03098979|"~     The objective of the study is to find the optimal dose of once daily oral neladenoson~     bialanate (BAY1067197) when given in addition to appropriate therapy for specific~     comorbidities.~   "
35727|NCT03098966|"~     The purpose of the study to evaluate the practice and short term maternal and perinatal~     outcomes of trial of labor after cesarean section offered to women at Ain Shams University~     Maternity Hospital (ASUMH) during the 3-year period from January 2013 to December 2015.~   "
35728|NCT03098953|"~     Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat~     Ocular Instillations of Loteprednol Etabonate Ophthalmic Gel~   "
35729|NCT03098940|"~     This study is a two part study~   "
35730|NCT03098927|"~     The overall vision of this proposal is to demonstrate that a virtual reality based motor~     imagery training program will improve brain computer interface (BCI) performance and motor~     function in quadriplegic subjects. The ultimate goal is to increase the independence of~     subjects with spinal cord injury by training to safely control BCI assistive devices and to~     enhance motor recovery.~   "
35731|NCT03098914|"~     Community-Acquired Pneumonia has become common. Additionally, the mortality is high. But the~     epidemiology of pathogen is various in different areas, which is crucial for the key~     treatment. In addition, the risk factors of patients who died in 3 or 7 days in china is not~     clear, comparing with patients who died in 14 or 28 days or who survived.~   "
35732|NCT03098901|"~     Cardiac amyloidosis is a multi-organ syndrome, which usually presents as restrictive~     cardiomyopathy (RCM). Transthyretin (TTR) amyloidosis (or ATTR) is a subtype of amyloidosis~     which frequently involves heart. Cardiac ATTR, though infrequently diagnosed during lifetime,~     may represent a prevalent cause of RCM, especially in elderly. Several medications that can~     limit progression of the disease are currently under investigation. Presently the golden~     standard for diagnosis of ATTR is endomyocardial biopsy (EMB) which may entail severe adverse~     complications causing under-diagnosis of ATTR.~      Several papers support the evidence that Tc99m-labeled tracers can be used to detect~     myocardial deposits of TTR amyloid. It was suggested that Tc99m scintigraphy might be a~     highly sensitive diagnostic tool for cardiac ATTR. In this study the patients with otherwise~     unexplained cardiomyopathy or heart block will undergo Tc99m scan, which will establish the~     incidence of this largely underdiagnosed condition in the population.~   "
35733|NCT03098888|"~     Little is known about bronchoalveolar lavages performed for cytological assessment during~     bronchial fibroscopy in critically ill patients. Frequency of use, indications, actual~     contribution to diagnosis and therapeutic decision, and complications have not been~     extensively assessed.~      The primary objective of this multi center, prospective, observational study is to describe~     the frequency of use of bronchoalveolar lavages for cytological assessement in critically ill~     patients, identify their indications, assess their contribution to diagnosis and therapeutic~     decisions, and estimate the frequency of induced respiratory events.~   "
35734|NCT03098875|"~     Patients were randomized into 2 groups according to the anesthetic, propofol or sevoflurane.~     Induction and maintenance were standardized, and after the end of surgery, two steady-state~     recordings were performed at BIS 25 and BIS 55. Bispectral Index and ECG were continuously~     recorded and cardiac autonomic nervous activity was investigated using spectral analysis of~     RR Interval variability~   "
35735|NCT03098862|"~     Background:~      Genes are instructions that tell the body how to work and grow. They can affect how the body~     responds to infection. Researchers want to learn more about genes that affect how the body~     responds to the Ebola virus. Some people with Ebola get very sick and die. Others do not. The~     research may lead to better treatments for Ebola virus and other germs.~      Objective:~      To look for genes that may be related to a person s chance of getting very sick after coming~     in contact with the Ebola virus.~      Eligibility:~      People at least 3 years of age who either:~      Had Ebola~      Had close contact with someone who had Ebola~      Were in an Ebola vaccine study~      Design:~      Participants will have a small amount of blood taken from an arm vein by a needle.~      Researchers will collect participants data from other vaccine studies they may have been in.~      Participants may be asked questions about their health and social history.~      Some participants will have their blood tested for the infection syphilis and HIV, the virus~     that causes AIDS. Participants will be told the results and will get help finding care, if~     necessary.~      Some participants will have their blood sample tested to see if they have had Ebola in the~     past.~      Blood samples will be stored for future research. They will be marked with a code but not~     with participants names.~   "
35737|NCT03098836|"~     The primary goal is to prospectively estimate the median PFS of African American and~     Caucasian men with mCRPC taking apalutamide, abiraterone acetate, and prednisone. Secondary~     objectives include: PSA kinetics: to determine the duration of PSA response, time to nadir,~     and percent of men who achieve a PSA < 0.1; Radiographic assessments: to estimate the rate of~     objective response and incidence of bone flares; Safety (NCI CTC v4.0) and tolerability,~     particularly incidence and grade of hypertension in the two populations.~      This is a non-comparative pilot open-label, parallel arm, multicenter study of apalutamide~     and abiraterone acetate in African American and Caucasian men with mCRPC. It is anticipated~     that 3 additional sites will be needed to accrue 100 subjects (50 African American and 50~     Caucasian) over a 24 month accrual period. The study agents will be administerd at the~     following doses: apalutamide 240mg orally once daily, abiraterone acetate 1000mg orally once~     daily, and prednisone 5 mg BID in 4-week cycles throughout the treatment period.~      Fifty (50) patients will be enrolled in each group (AA and Caucasians). The proportion of~     patients who experience PSA decline of 30%, 50% and 90% will be estimated with exact 95%~     confidence intervals based on the binomial distribution will be computed. In addition, post~     therapy changes in PSA will be explored as a continuous outcome. The Kaplan-Meier product~     limit method will be used to estimate the rPFS, biochemical PFS and overall survival~     distributions.~   "
35738|NCT03098823|"~     To compare the effect of RAYOS® versus immediate-release (IR) prednisone on fatigue as~     measured by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F).~   "
35739|NCT03098810|"~     Zinc supplementation effect on appetite and growth of malnourished children~   "
35740|NCT03098797|"~     A randomized double-blind cross over trial to evaluate the safety, efficacy and tolerability~     of elamipretide in subjects with Barth Syndrome.~   "
35741|NCT03098784|"~     The goal of this study is to assess the respiratory health of the Air France company's~     employees working in the Marseilles and Paris airports (flight line and administrative~     employees). This study was promoted by the Montpellier CHRU, Regional University Hospital~     Centre (ANSM identification number 2011-A00646-35). It allowes voluntary employees to be~     involved. They answer a lifestyle survey and perform a spirometry, an exhaled CO measurement~     and a sampling of exhaled air condensate (EAC). A metrological study of particles emitted by~     aircraft engines and found in the airport environment will be conducted and the elementary~     chemical composition analysis, as well a sieve analysis of particles present in the EAC will~     be conducted.~   "
35742|NCT03098771|"~     To verify angiogenesis in elderly patients with atherosclerotic ischemia after peripheral~     blood autologous CD34+ cell transplantation.~   "
35743|NCT03098758|"~     Gastric carcinoma is a disease with a high mortality. Peritoneal washing cytology has a~     recognized prognostic utility. However sensibility of this study is not appropriate. Studies~     with PCR (polymerase chain retrotranscription) can increase sensibility and accurate staging~     information.~      Objective: To analyze the sensibility and specificity of the expression of CK20, CEA and~     Ber-EP4 with PCR technique in peritoneal washings of advanced gastric carcinoma without~     clinical evidence of peritoneal carcinomatosis.~      Methodology: Retrotranscription analysis (RT-PCR) and quantitative PCR (qPCR) of CK20, CEA~     and Ber-EP4 in peritoneal washing. Test the feasibility of qPCR with this new marker~     (Ber-EP4). Comparison of the results with data obtained with conventional cytology. Study of~     peritoneal recurrence.~   "
35744|NCT03098745|"~     The aim of this non-dispensing fitting study is to evaluate the short term lens fit, vision~     performance of three monthly replacement sphere lenses.~   "
35745|NCT03098732|"~     The objective of the MEDIS study is to determine if subjects experiencing an Acute Ischaemic~     Stroke due to large vessel occlusion, treated with IV tPA combined with the MED procedure~     have a greater likelihood of recanalisation 30-90 minutes after the completion of tPA~     infusion than subjects treated with IV tPA (plus sham device). Safety of the MED System~     Procedure will be evaluated by the incidence of symptomatic PH-2 haemorrhagic transformation~     within 24 hours following the procedure. Lastly, a health economics study will be conducted~     to estimate health care costs for each treatment.~   "
35746|NCT03098719|"~     GISMO combines spatial information with findings on the health effects of sustainable, active~     forms of mobility in the work environment in order to derive evidence-based decision-making~     bases for a health-promoting, operational mobility management. Existing approaches - with~     regard to spatial information systems, decision-support systems and health effects of active~     mobility - are considered and supplemented by our developments and investigations. Achieved~     non-personal results are provided through standardized web interfaces, ensuring integration~     into existing and prospective tools of an innovative and health-promoting mobility~     management.~   "
35747|NCT03098706|"~     Each year, only one third of patients registered on the waiting list receive a kidney~     transplant. Numerous paths are being explored with the aim of reversing this shortage. The~     first is to increase the number of organs by developing harvesting from donors in a state of~     brain-death (BD) termed expanded criteria donors or from patients deceased from circulatory~     arrest.~      Another fundamental factor is to insure the success of the transplant by limiting the~     dysfunction of donor kidneys, marked by a delayed graft function (DFG).~      The development of techniques to insure correct perfusion of harvested organs, and the~     optimization of reanimation and intensive care of brain-dead donors constitute important~     factors in DGF reduction.~      Therapeutic Hypothermia could to be an attractive care strategy for BD patients.~   "
35748|NCT03098693|"~     This is a prospective observational study of couples in Kisarawe, Tanzania who will be~     provided an intervention that offers: (1) HIV self-testing kits and pre-test counseling~     provided at the household, (2) linkage to a counseling and referral center for those who test~     positive, (3) facilitated enrollment to care and treatment for couples with confirmed HIV~     infection; and (4) access to pre-exposure prophylaxis for the negative partner in a HIV~     sero-discordant couple. We will identify HIV sero-discordant couples through the HIV~     self-testing component, and through identifying discordant couples at the local HIV clinic.~     HIV sero-discordant couples (N=60 couples) will be administered a baseline, 6- ,12-, and~     18-month survey, and the investigators will collect ongoing clinical data from each clinic~     visit. Biometric data (fingerprint) will be collected at enrollment, and all encounters with~     the counseling and referral center, and HIV treatment center, to allow linking of utilization~     of services with survey data.~   "
35749|NCT03098680|"~     Unwanted effects on the cardiovascular system is one of the most common causes of safety~     related discontinuation of a drug. This study aims to develop an in silico model of the human~     cardiovascular system that can be used to predict unwanted cardiovascular effects of drugs.~     This will be achieved through a drug administration study that will generate comprehensive~     pharmacokinetic and pharmacodynamic data following the administration of the following drugs,~     all known to have effects on the cardiovascular system. Half the participants will receive:~     Placebo, Salbutamol, Nicardipine, Dobutamine and the other half will receive Placebo,~     Phenylephrine, Verapamil, Phentolamine.~   "
35750|NCT03098667|"~     The patients will be allocated to 2 groups: the LMA group and the endotracheal tube (ET)~     group. Airway management will be done with the LMA Protector for the patients of the LMA~     group and with the classic endotracheal tube for the patients of the ET group. The main~     purpose of the study is to determine if the application of the LMA Protector causes less~     laryngopharyngeal symptoms than the endotracheal tube after minimally invasive thyroidectomy.~     The secondary purpose is to confirm that the LMA Protector is a safe alternative airway~     management device for minimally invasive thyroidectomy.~   "
35751|NCT03098654|"~     This study focuses on the integration of HIV and NCD screening and care. The investigators~     will conduct a randomized controlled trial examining the efficacy and cost-effectiveness of~     the intervention strategy in Kisarawe District, Tanzania, a rural area 40 KM southwest of Dar~     es Salaam. The study will match two similar HIV care and treatment centers (CTC) in the~     District, one of which will be randomized to receive the enhanced intervention which will~     integrate diabetes (DM) and hypertension (HTN) screening with the existing HIV testing~     program, and integrate care for DM and HTN into the HIV care program. Comparisons of the~     community HIV testing rates in the two communities, engagement in HIV care among those~     testing positive, and 24-month retention in HIV care will be assessed among a cohort of 89~     newly enrolled patients per community.~      Specifically, the aims are to determine:~        1. Whether integrating DM and HTN screening with HIV testing will increase the uptake of~          community-level HIV testing.~        2. If integrating DM/HTN care with HIV care enhances engagement in HIV care.~        3. Whether integration of DM/HTN care with HIV care enhances retention in HIV care for~          those newly enrolled in HIV care.~        4. The cost-effectiveness of integrating NCD screening and care with HIV screening and care~          with regard to the incremental cost per HIV infected client engaged in HIV care, and~          cost per newly enrolled HIV client retained in HIV care over 24-months.~   "
35752|NCT03098641|"~     Pelvic organ prolapse repair involves conservative treatments and surgical treatments.~     Conservative treatments are for patients with moderate prolapse. Treatment of symptomatic~     prolapse remains essentially surgical. According to detailed medical history and a thorough~     physical exam, surgical techniques may be performed by high abdominal, low vaginal or mixed~     routes with or without the use of a reinforcing implant. Restorelle Direct Fix is indicated~     for transvaginal anterior and posterior surgical repair either as mechanical support or as~     reinforcement of pelvic floor defects. Advantages and disadvantages of vaginal prostheses are~     known but only limited data have been reported on the use of Restorelle® in the treatment of~     pelvic organ prolapse. This study is designed to collect data on the safety and efficacy of~     Restorelle® Direct Fix in pelvic organ prolapse repair.~   "
35753|NCT03098628|"~     This is a single-blind, open-label, randomised controlled trial with five groups. There are~     four different Pneumococcal Conjugate Vaccine (PCV) schedules to be evaluated.~   "
35754|NCT03098615|"~     This study will examine how Jublia affects dermatophytomas, which are difficult to treat with~     other therapeutic options.~   "
35755|NCT03098589|"~     To understand the safety and efficacy of Revlimid® Capsules 2.5 mg and 5 mg (hereinafter~     referred to as Revlimid) under actual conditions of use in patients with relapsed or~     refractory adult T-cell leukemia lymphoma (hereinafter referred to as relapsed or refractory~     Adult T-cell Leukemia Lymphoma (ATLL)).~        1. Planned registration period 3 years~        2. Planned surveillance period 4 years and 6 months after a month after the approval for~          partial changes in the approved items is granted for relapsed or refractory ATLL~   "
35756|NCT03098576|"~     The purpose of this study is to examine the usefulness of matching patients to targeted~     therapy by analyzing a tumor sample taken at diagnosis and testing it against 50~     cancer-associated genes. Targeted therapy is a highly personalized, newer approach to cancer~     treatment that aims to more precisely identify and attack cancer cells, in an effort to do~     less damage to normal cells.~   "
35757|NCT03098563|"~     This research is being done to evaluate whether combining medications that are FDA approved,~     but have not yet been approved for combination treatment, can be effective in reducing pain.~   "
35758|NCT03098550|"~     The purpose of this study is to determine whether a combination of Nivolumab and Daratumumab~     is safe and effective when treating Pancreatic, Non-Small Cell Lung or Triple Negative Breast~     Cancers, that have advanced or have spread.~   "
35759|NCT03098537|"~     Enteral nutrition can provides prophylaxis against stress ulcer bleeding in critically ill~     patients and there may be no need to use acid suppressing drugs for stress ulcer bleeding~     prophylaxis in these patients. Half of the patients on enteral nutrition will not receive any~     acid suppressing drugs while other half receives it. They will be followed for~     gastrointestinal bleeding.~   "
35768|NCT03098420|"~     The study aims to improve the care of the obstetric population after cesarean section and~     improve total patient satisfaction by improving post-surgical pain control with the use of~     dexamethasone in combination with bilateral TAP blocks. The investigators will utilize a~     dose-escalation of dexamethasone in the TAP block to observe its effects at specific small~     doses. It is the hope of the investigator that the studied technique would become utilized~     routinely for the obstetric population following cesarean section.~      The investigators hope to show that the addition of dexamethasone in bilateral TAP blocks~     will prolong the duration of the block in a dose-dependent fashion. The investigators hope to~     improve post-operative pain following cesarean section, increase duration of TAP block with~     use of dexamethasone, decrease overall pain scores in the first 24-48 hours, and decrease~     opioid requirements after cesarean section.~      The primary endpoint will be estimation of duration of TAP block, being assessed within 48~     hours after surgery. Secondary endpoints will include pain scores both in PACU and on the~     floor, average pain scores, time until first opioid administration, total opioid consumption~     in first 48 hours, use of PONV medications, and overall patient satisfaction.~   "
35760|NCT03098524|"~     BACKGROUND. Postoperative pulmonary complications are a leading cause of morbidity and~     mortality after cardiac surgery. To this date, there are no recommendations regarding~     mechanical ventilation associated with cardiopulmonary bypass (CPB) during the surgery and~     anesthesiologists perform either no ventilation (noV) at all during CPB or maintain a~     low-tidal volume ventilation (LTV). Indirect evidence points towards better pulmonary~     outcomes when LTV is performed but no proper prospective trial with large inclusion of all~     types of cardiac surgery has been published.~      DESIGN. The MECANO trial is a single-center, double-blind, randomized controlled trial~     comparing two mechanical ventilation strategies, noV and LTV, during cardiac surgery with~     CPB. 1500 patients will be included for whom planned cardiac surgery with CPB is performed.~     They will be randomized between noV and LTV, on a 1:1 ratio. The noV group will receive no~     ventilation during CPB. The LTV group will receive 5 acts/minute with a tidal volume of 3~     mL/kg and positive end-expiratory pressure of 5 cmH2O. Primary endpoint will be composite of~     overall death, early respiratory failure defined as PaO2/FiO2 ratio <200 mmHg at one-hour~     after arrival in the ICU, heavy oxygenation support (defined as a patient requiring either~     non-invasive ventilation, mechanical ventilation or high flow oxygen) at 2 days after arrival~     in the ICU or ventilator acquired pneumoniae defined by Center of Disease Control. Lung~     recruitment manoeuvers will be performed for noV and LTV groups, at the end of surgery and at~     the arrival in ICU with an insufflation at +30 cmH20 during 5 seconds. Secondary endpoints~     are those composing the primary endpoint with the addition of pneumothorax, CPB duration,~     quantity of postoperative bleeding, red blood cells transfusions, revision surgery~     requirements, length of stay in the ICU and in the hospital and total hospitalization costs.~     Patients will be followed until hospital discharge.~      SUMMARY. The MECANO trial compares a no-ventilation to a low-tidal volume strategy for~     mechanical ventilation during cardiac surgery with CPB, regarding a primary composite outcome~     including death, respiratory failure and pneumoniae.~   "
35761|NCT03098511|"~     For the purpose of organ donation after neurological determination of death (NDD), death must~     be declared using a set of standardized clinical criteria. When a full clinical evaluation~     cannot be completed, additional neuroimaging ancillary testing is required. The ideal~     ancillary test for NDD would demonstrate no cerebral blood flow, be free of false-positive~     and false negative results, rapid, safe, readily available, non-invasive, and inexpensive. No~     current ancillary test for NDD meets these criteria. Computed tomography (CT) perfusion has~     the characteristics of an ideal test for NDD, but has not been evaluated for routine clinical~     use for NDD.~      The overarching goal of this project is to improve the NDD process by establishing~     CT-perfusion as the ideal ancillary test. A large prospective Canadian multi-centre~     diagnostic cohort study will be conducted to validate CT-perfusion for the neurological~     determination of death.~      Specific objectives are:~      Primary objective: To determine diagnostic accuracy of CT-perfusion compared to complete~     clinical evaluation for NDD.~      Secondary objectives: 1) To confirm the safety of performing CT-perfusion in critically ill~     patients suspected of being neurologically deceased; 2) To establish the CT-perfusion~     inter-rater reliability for NDD; 3) To evaluate the diagnostic accuracy of CT-angiography~     compared to complete clinical evaluation and to CT-perfusion for NDD; 4) To describe the~     clearance of commonly used sedatives and narcotics in the setting of NDD; and 5) to~     investigate biological changes (inflammatory and nanovesicles) that occur in humans during~     the brain dying process.~   "
35762|NCT03098498|"~     This study compared the gain of periodontal attachment after concomitant one-stage removal of~     bacterial biofilms and subgingival calculus with a two-stage procedure removing subgingival~     calculus 6 weeks after the initial removal of soft subgingival bacterial biofilms.~   "
35763|NCT03098485|"~     The objective of this study is to evaluate the impact of antimicrobial (antibiotic) exposures~     on the microbiome in healthy adults, specifically during and after usual courses of the~     antimicrobials used to treat community acquired pneumonia (CAP). Pneumonia is a lung~     infection, and community-acquired pneumonia is pneumonia that develops outside of a~     healthcare facility (i.e., in the community). A microbiome is a the community of~     microorganisms living in a particular location, such as the gut or the mouth. Disruptions to~     a person's microbiome may reduce his/her colonization resistance (resistance to~     colonization with pathogenic microorganisms) and make him/her more susceptible to multidrug~     resistant organism (MDRO) colonization and infection.~      To study changes in the microbiome, the investigators will recruit 20 healthy adult~     volunteers and obtain fecal, salivary, skin, and urine specimens at multiple time points~     before, during, and after administration of antimicrobials. Participants will be randomized~     to one of 4 antimicrobial regimens, all of which are FDA-approved for treatment of~     community-acquired pneumonia. Stool specimens will be analyzed via stool culture and genetic~     sequencing, and all remaining specimens will be frozen and used to create a biospecimen~     repository for future analysis. The rationale for using healthy volunteers (instead of~     patients already prescribed antibiotics by their physicians) is because the human microbiome~     is very complex and can be affected by a variety of medical conditions and other medications.~     In addition, the presence or absence of patient-specific factors means people with infections~     may not be prescribed the specific courses of antibiotics the investigators are trying to~     study. Studying the effect of antibiotics on healthy volunteers will provide baseline data~     that are more applicable to the population at large.~   "
35764|NCT03098472|"~     Delirium is a syndrome of acute brain dysfunction involving attention and cognition that~     affects up to half of older hospitalized patients and 50%-75% of critically ill ICU patients,~     such that millions of patients worldwide experience this acute threat to their health and~     well being every year. One-third to half of critical illness survivors struggle with a~     dementia-like disorder similar in severity to moderate-to-severe traumatic brain injury or~     Alzheimer's Disease, and the only proven risk factor that is potentially modifiable is~     delirium in the ICU. Despite the frequency and impact of delirium in the ICU, little is known~     regarding the biological mechanisms that lead to this form of organ dysfunction during~     critical illness. A widely held hypothesis proposes that inflammation is regulated by the~     cholinergic system, and that this interaction plays a pivotal role whether delirium~     developments in the setting of acute illness. Acetylcholinesterase (AChE) and~     butyrylcholinesterase (BuChE) are enzymes that hydrolyze the neurotransmitter acetylcholine.~     Changes in the activity of these enzymes, which can be measured in whole blood, reflect~     altered regulation of circulating acetylcholine. AChE and BuChE activities have promise as~     both predictors of delirium (when found to be low at admission) and biomarkers of delirium~     (when low during serial measurement). Neither of these biomarkers, however, have been studied~     in the ICU setting where delirium risk is the highest. The current investigation, therefore~     will be the first to determine the validity of circulating AChE and BuChE activities as~     biomarkers of delirium during critical illness and subsequent cognitive impairment after~     discharge. This study will measure whole blood AChE and butyrylcholinesterase BuChE~     activities within the framework of the ICU Delirium and Cognitive Impairment Study Group's~     ongoing clinical trials in critically ill patients.~   "
35765|NCT03098459|"~     Cognitive skills are essential to live independently, manage finances, maintain employment,~     and function in society. Loss of these cognitive skills puts a tremendous burden on society~     as seen with dementias, Alzheimer's disease, and traumatic brain injury. The INSIGHT-ICU~     Study (Illuminating Neuropsychological dysfunction and Systemic Inflammatory mechanisms~     Gleaned after Hospitalization in Trauma-ICU Study) is the first comprehensive and~     longitudinal long-term cognitive impairment study after traumatic injury. The societal impact~     of long-term cognitive impairment after trauma is immense given that these patients are young~     and constitute a large proportion of employable adults.~   "
35766|NCT03098446|"~     The purpose of this study is to investigate the effect of 4 days of sitting and moderate~     exercise on plasma triglyceride elevation after a meal.~   "
35767|NCT03098433|"~     This study will assess the short term effects of a single dose of liothyronine on the~     cardiovascular system and energy expenditure~   "
35796|NCT03098056|"~     The study evaluated and the safety, tolerance and acceptability of a lifestyle modification~     program with nutritional supplementation in generally healthy overweight subjects with~     cardiometabolic risk factors. Experience will be compared to a historical controls.~   "
35769|NCT03098407|"~     The incidence of opioid dependence in pregnancy increased over the last decade from 1.2 to~     5.8 per 1,000 hospital births per year.1 While methadone is the current, standard treatment~     for opioid dependent (OD) pregnant women, buprenorphine recently emerged as an alternative.~     In a recent clinical trial (MOTHER), buprenorphine was associated with superior neonatal~     outcomes such as shorter duration of treatment for neonatal abstinence syndrome (NAS)~     compared to methadone. However, buprenorphine was also associated with greater study~     discontinuation (33% vs. 18%) and illicit opioid use (33% vs. 23%) compared to methadone.~     Treatment dropout often leads to relapse and resumption of high-risk behaviors, overshadowing~     any short-term improvement in neonatal outcomes. Therefore, The goal of this K23 proposal is~     to conduct a pilot study to establish the feasibility and acceptability of a randomized~     comparative effectiveness clinical trial comparing office-based buprenorphine vs. federally~     licensed methadone programs for the treatment of OD pregnant women.~      A pilot study is critical to develop the outcome measures, assessment tools and participant~     tracking techniques necessary for a future, large-scale comparative effectiveness clinical~     trial. An examination of feasibility and acceptability will also allow use to characterize~     the subpopulations of OD pregnant women willing to participate in treatment randomization,~     identify patient and provider characteristics associated with established treatment~     preferences and inform the development of strategies to improve participation and enhance the~     generalizability of the future large-scale clinical trial.~   "
35770|NCT03098394|"~     The purpose of this study is to evaluate the effect of utilizing a rapid turnaround CT/NG~     test on treatment of female patients in the emergency department or urgent care setting with~     possible STIs.~   "
35771|NCT03098381|"~     One of religious duties for all healthy adult Muslims is fasting during Ramadan, the ninth~     month of Islamic lunar calendar. In this month, Ramadan observance fasted (no food and drink)~     from dawn to dusk. Studies demonstrated daytime fasting may pose a positive significant~     effect on metabolic health. Thus, this present study aimed to determine the effect of Ramadan~     fasting on body composition, metabolic profile, serum leptin and adiponectin levels in~     healthy men.~   "
35772|NCT03098368|"~     Parkinson's disease (PD) is the neurodegenerative disease which is caused by Lewy bodies~     deposition in central and peripheral nervous system. The mains symptoms include both motor~     and non motor symptoms such as bradykinesia, rigidity, rest tremor, postural instability,~     autonomic dysfunction or neuropsychiatric symptoms. Moreover, the PD symptoms not only occur~     in the daytime, but also in the nighttime. The nighttime symptoms or nocturnal symptoms can~     make the patients disabling as well as the daytime symptoms. The bradykinesia that occurs in~     the nighttime is called nocturnal hypokinesia which also make many serious consequences such~     as bedsore, falling or aspiration or death.~      In this study, the investigators aim to study the effects of rotigotine transdermal patch~     compare to placebo on mainly the aspect of nocturnal hypokinesia.~   "
35773|NCT03098355|"~     Clinical studies of CD19 CAR-T cells in the treatment of blood and lymphatic system tumors~     have achieved unprecedented successes. Because of the heterogeneity of the tumor, patients~     often carry CD19-negative tumor cell clones that express alternative target antigens (such as~     CD22, CD20 and CD123). In order to effectively eradicate all tumor clones and prevent~     recurrence, alternative tumor antigens besides CD19 are considered for CAR-T cell targeting.~     In this tudy, autologous T cells are genetically modified with 4th generation anti-CD19 and~     anti-CD22 CARs (4SCAR19/22) using lentiviral vectors. For safety consideration, the 4SCAR is~     engineered with an inducible caspase 9 self-withdrawal genetic design that allows for rapid~     elimination of the infused CAR-T cells. Interleukin-2 has been shown to boost immune response~     against leukemia cells. The serum interleukin-6 level will be monitored and when it returns~     to normal range by day 28 after CAR-T cell infusion, patients will receive subcutaneous~     injection of interleukin-2, and evaluated for 24 months for safety, efficacy and persistence~     of CAR T cells.~   "
35774|NCT03098342|"~     Study centre and address~      King Chulalongkorn Memorial Hospital~      Primary objective~      To compare the efficacy and the safety of methylene blue-mediated photodynamic therapy and 5%~     amorolfine nail lacquer for toenail onychomycosis in Asians~   "
35775|NCT03098329|"~     This study, named Check it, is a bundled program for African American (AA) men ages 15-24~     that includes community testing for chlamydia and gonorrhea, expedited treatment for subjects~     who test positive and their female sexual contacts, and rescreening for these two sexually~     transmitted infections.~   "
35776|NCT03098316|"~     Metabolomics consists in the study of metabolites in body fluids or tissues. It investigates~     the consequences of the activity of genes and proteins. One of its advantages is that it is~     able to do a simultaneous measurement of metabolic changes in living organisms as a response~     to a disturbance (disease, diet, environment, others) and because a metabolic profile is~     summative of all the biochemical processes occurring in the body at a given time, it makes no~     presumption about the relative importance of these processes. Ultimately it is a fingerprint~     of the organism's health status, at a given time.~      Metabolomic analysis of serum, plasma and urine has revealed panels of metabolites that~     distinguish patients with cardiovascular disease, breast cancer, Parkinson disease,~     Alzheimer's disease and diabetes from control patients. Regarding ocular diseases only few~     studies have been published, related to diabetic retinopathy, retinal detachment, age-related~     macular degeneration, uveitis and glaucoma.~      Glaucoma is one of the leading causes of blindness in the world, according to the World~     Health Organization, and there are still no biomarkers that can provide an early diagnosis.~     Nowadays, glaucoma classification relies substantially in the measurement of intraocular~     pressure (IOP), which can be rather artificial and also unreliable since IOP values can~     fluctuate during the day. Moreover, patients with normal IOP values can also develop~     glaucomatous neuropathy (normal-tension glaucoma, NTG) and progress even when IOP is~     decreased. Several studies have shown that NTG patients suffer from a systemic vascular~     dysregulation, with higher rates of systemic hypotension, Raynaud phenomenon and migraine.~     Hence, other mechanisms than an increased IOP are of importance in the development and~     progression of glaucoma.~      Only one metabolome-wide study has been made in glaucoma (Burgess, I.; 2015). In a sample of~     72 american patients with primary open angle glaucoma (POAG), the authors found significant~     differences in comparison to controls.~      The hypothesis for this study is that glaucoma patients will differ from controls, and POAG~     patients will differ from NTG patients. The investigators will look into metabolomics as a~     way to create a method to diagnose and stratify patients, as an add-on or alternative to the~     currently available diagnostic tools like IOP, functional and structural measurement.~   "
35777|NCT03098303|"~     The primary objective of this study is to determine the variables associated with patient~     acceptation or refusal to participate in a clinical research protocol when seen in during a~     pneumology consultation (excluding oncology and tobaccology).~   "
36076|NCT03094390|"~     This study aims to test the accuracy of the total thoracic fluid content (TFC) measured by~     cardiometry can predict weaning-induced pulmonary edema and subsequently weaning failure.~     Area under receiver operating characteristic curve (AUROC) will be determined, sensitivity,~     specificity, and best cutoff value will be calculated for TFC in prediction of weaning~     failure.~   "
35778|NCT03098290|"~     The prevalence of peripheral arterial disease (PAD) and the proportion of endovascular~     procedures for treatment are increasing worldwide. For many cases of treatment or procedures~     no randomized controlled trials (RCT) or results from meta-analyses are so far available. The~     decision for treatment and selection of procedure is therefore not uncommonly left up to the~     personal expertise of the physician. The IDOMENEO study represents a multistage~     multimethodological project for healthcare research and quality assurance in~     interdisciplinary vascular medicine, which undertakes a comprehensive examination of this~     topic. Various methods and data sources (even routine data) are linked in a meaningful way.~     The essential components of the total project are implementation of a register platform~     (GermanVasc), which conforms to data protection and data security as well as the development~     of instruments for valid measurement of the quality of life of patients with PAD. The data~     protection-conform linking of primary data in the register and routine data of the consortium~     partner BARMER should also enable validation of the data sources.~   "
35779|NCT03098277|"~     This clinical trial studies movement tracking devices in optimizing and monitoring physical~     activity in patients with solid tumors undergoing chemotherapy in a health care facility~     during the day without spending the night. Movement tracking devices, such as Microsoft~     Kinect 2 and Microsoft Band 2, may help doctors learn about the health of cancer patients.~   "
35780|NCT03098264|"~     For some complicated hepatolithiasis, it is difficult to decide whether to perform surgery on~     biliary stone and portal hypertension simultaneously or separately by staged surgery.There's~     a high risk of intraoperative bleeding, postoperative liver failure and variceal bleeding for~     these patients.How to develop a optimized algorism of simultaneous and staged surgery is~     highly needed.~   "
35781|NCT03098251|"~     According to a large amount of case affected with hepatolithiasis, we developed a typing~     system of Hepatolithiasis based on 3D digital conformation. And we hypothesized that it could~     predict a more precise construction of this disease, hence, typing by 3D conformation will~     improve the outcome of surgical treatment.The investigators will use a multicenter~     ambispective cohort study to test this hypothesis.~   "
35782|NCT03098238|"~     Context and rationale:~      Antibody-mediated rejection is the leading cause of long-term renal graft loss. It's due to~     the production by the recipient of antibodies directed against antigens (belonging or not to~     the HLA system) present on the surface of the donor specific endothelial cells (DSA), leading~     to graft failure.~      The main difficulty to manage the humoral rejection is the delay of the diagnosis and the~     treatment to slow the evolution towards fibrosis.~      Positivity of anti-HLA antibodies is the main risk factor for the rejection but the only way~     to make the diagnosis of humoral rejection is to perform a graft biopsy, an invasive process.~      Endothelial microparticles (MPE) are small membrane vesicles generated by endothelial cell~     activation and / or apoptosis processes.~      We test the hypothesis that endothelial microparticles are an early diagnostic biomarker of~     humoral rejection in renal transplantation allowing to detect it at the subclinical stage.~      Primary and secondary objectives:~      The main objective of this study is to estimate the performance of MPE plasma concentration~     for the diagnosis of humoral rejection in renal transplant patients with DSA. The secondary~     objective is to investigate by mass spectrometry the MPEs specific to the endothelium of the~     graft and to evaluate their diagnostic performance in relation to non-specific MEPs~      Methodology :~      We will conduct a cross-sectional evaluation of a diagnostic method from a collection of~     biological samples. The gold standard for the diagnosis of humoral rejection is the~     histological diagnosis on graft biopsy. The new test under study will be the flow cytometric~     assay of the MPE concentration carried out on plasma taken on the day of the graft biopsy.~      Feasibility:~      Among the active list of renal transplant patients attending the Montpellier University~     Hospital, we estimate that we can include the number of subjects required (N = 250) over 18~     months. This work will be carried out in a laboratory with all the tools and techniques used,~     in particular flow cytometry and mass spectrometry, perfectly mastered and realized on~     dedicated technical platforms~      Benefits / Outlook:~      find a non-invasive early diagnostic biomarker to detect humoral rejection from the~     subclinical stage in order to set up an adapted treatment as quickly as possible.~   "
35783|NCT03098225|"~     Graves' orbitopathy (GO) is a disfiguring and disabling disease that profoundly impairs the~     quality of life of affected patients. High dose intravenous (iv) glucocorticoids (GC) (ivGC)~     is a well established, widely used treatment for active GO. The use of systemic~     glucocorticoids takes advantage from their immune suppressive and antiinflammatory actions,~     resulting in an overall beneficial effect ranging from ~35 to ~60% of patients in various~     studies. The intravenous route of administration has been shown to be superior to the oral~     route, both in terms of GO outcome and side effect profile. The combination of ivGC and~     orbital radiotherapy (OR) is used routinely in patients with moderate-severe, active GO, as a~     second-line treatment, as also recommended in the recent Guidelines published by the European~     Thyroid Association/European Group on Graves' Orbitopathy. Thus, the majority of studies have~     shown that OR increases the response rate to GC. Those studies were performed using oral GC,~     whereas it is not known whether OR potentiate also the effects of ivGC.~      The present study is aimed at determining whether OR potentiate the effects of ivGC in the~     treatment of moderately severe and active GO, in terms of GO outcome and quality of life. A~     possible extension of the study can be foreseen, aimed at investigating the very long time GO~     outcome.~   "
35784|NCT03098212|"~     Pregnant women who eligible with inclusion criteria are random to two groups. Aromatherapy~     group will receive the aromatherapy during labor along with standard pain control.~      Non-aromatherapy group will receive standard pain control during labor~   "
35785|NCT03098199|"~     This is a research study on a hormone in women called anti-mullerian hormone (AMH) an~     indicator of the amount of egg reserve in the ovaries. The research involves a blood draw to~     determine the AMH level. This knowledge will help the investigators decide a dosage of~     gonadotropins, the hormones used to stimulate the production of more than one egg for use in~     an in vitro fertilization (IVF) cycle. The amount of gonadotropin given has to be tailored to~     each individual participant. The investigators can use information about the participant and~     the hormone levels to determine this dosage and the chances of becoming pregnant as a result~     of IVF treatment. The reason the investigators are doing this research is to find out if~     basing the gonadotropin dosage solely on the participant's AMH level will give the~     investigators a better result than the previous method based on age and other hormone levels.~   "
35821|NCT03097731|"~     The presentation of IBD in early childhood is uncommon and the monogenetic defects,~     especially IL-10 signaling pathway play a key role in very early onset inflammatory bowel~     disease (VEO-IBD). IL-10 or IL-10R deficiency associated VEO-IBD is considered a rare~     disorder. To date, there were about 60 cases were reported all over the word. But in our~     Chinese VEO-IBD Collaboration Group, 42 patients with biallelic mutations affecting IL10R~     genes were identified from 93 VEO-IBD patients, and the mutation sites are highly~     concentrated, including 83.9% (26/31) with p.R101W and 55% p.T179T (17/31) mutation, and the~     proportion of patients from Henan( A province of China) is higher. So we speculate that~     IL-10RA mutation may not be very rare, and the frequency of heterozygote subjects might be~     higher than suspected.~   "
35786|NCT03098186|"~     Purpose of the trial: To evaluate the efficacy and safety of an intervention with SMS~     messages delivered by mobiles phones to improve adherence to cardiovascular medications in~     patients with atherosclerotic cardiovascular disease (ASCVD).~      Trial design: Two-parallel arm, single-blind, individually randomized controlled trial.~      Primary endpoint: Differences in changes (baseline minus 12 months) of: Low density~     lipoprotein cholesterol (LDL-C), Systolic Blood pressure and Heart Rate.~      Secondary endpoints: Differences in the changes (baseline minus 12-months) of: (i) adherence~     to cardiovascular medications used in secondary prevention measured by MARS-5 questionnaire;~     and (ii) Urinary levels of 11 dh-TxB2, Rates of composite end-point of cardiovascular death~     and hospitalization due to cardiovascular disease up to 12 months, Rates of composite of~     non-cardiovascular death or hospitalizations due to non-cardiovascular disease up to 12~     months and Adverse events: traffic accidents and injuries while reading SMS related to the~     trial.~      Duration of follow-up: 12 months~      Trial treatment:~      Intervention: The active treatment will consist of SMS that are aimed to modified behavioral~     factors associated with poor adherence to cardiovascular medications used in secondary~     prevention. The SMS will be delivered daily during the first month, increasing one day of~     interval for each week during the second month, and weekly thereafter until end of month~     12th. In addition, they will receive SMS thanking for their participation in the trial,~     reminders of trial appointment and informing if they have changed contact details. The~     frequency of this SMS will be monthly.~      Control: participants will only receive the SMS thanking for their participation in the~     trial, reminders of trial appointment and informing if they have changed contact details. The~     frequency of this SMS will be monthly.~      Expected sample size, enrollment and expected number of centers:~      Sample size = 1600 Recruitment start date: March , 2017 Recruitment end date: September, 2017~     Follow-up end date: March, 2018 Number of centers: 1~      Statistical considerations:~        -  Intention to treat analysis~        -  The trial has >90% power (2 sided alpha= 0.05) to detect a reduction in LDL-C as low as~          5.1 mg/dl, under the assumption that SMS will increase adherence to statins by 7%.~        -  The primary outcomes will be analyzed using ANCOVA.~      Partially Financed by COLCIENCIAS Code: 656672553352~   "
35787|NCT03098173|"~     This multi-center, randomized controlled trial study is planned to include 162 outpatients~     with onset of acute lower gastrointestinal bleeding to compare the rate of identification of~     stigmata of recent hemorrhage (SRH), and other clinical outcomes, including the 30-day~     rebleeding rate, between 'early' colonoscopy and 'elective' colonoscopy.~   "
35788|NCT03098160|"~     An immunotherapy study combining ipilimumab and evofosfamide for the treatment of patients~     with confirmed metastatic or locally advanced prostate cancer, metastatic pancreatic cancer,~     melanoma or human papillomavirus (HPV) negative squamous cell carcinoma of head and neck that~     have failed to respond to standard therapy, progressed despite standard therapy, for which~     standard therapy does not offer the potential for increased survival.~   "
35789|NCT03098147|"~     Lower urinary tract symptoms(LUTS) are the main symptoms of benign prostatic~     hyperplasia(BPH), a benign but progressive disease which can advance to be with overactive~     bladder(OAB) symptoms. Moreover, LUTS and OAB symptoms can badly influence patients'~     especially the elderly's quality of life. Therefore, it appears to be urge to carry out~     researches on the functional impairment of bladder along with the advance of BPH. Besides,~     the management aimed at improving the LUTS and OAB symptoms come to be the key one among the~     management of BPH. For a long period, medication and surgery sustain to be the two most~     common therapies for BPH patients. Both patients and urologists prefer pharmacotherapeutics~     to surgery，which contributes to the rising number of BPH patients companied with OAB symptoms~     and storing symptoms complaint post-surgery. In fact, investigators usually find bladder~     impairment macroscopically in the BPH surgery: mild may be the trabeculation, worse can be~     the cabin, and severe may be the diverticula. Furthermore, it's not uncommon that patients~     with a long BPH history continually suffer from dysuria after surgery due to the detrusor~     muscle weakness. Consequently, investigators need to catch a moment when investigators should~     operate on such a patient in order to harvest a satisfying outcome. And perhaps the moment~     should be ahead of the existing guideline suggests. Thus, for understanding the influence of~     BPH on bladder function, investigators plan to conduct a prospective, case-control study~     recruiting in-patients with different degree of obstruction. Our team wish that such a~     clinical trail could provide valuable evidence for us to find out relatively better operating~     timing and serial indications. For the purpose of improving the quality of life and prolong~     life-span, investigators design the study above to maximum the operating outcome and minimize~     the bladder dysfunction.~   "
35790|NCT03098134|"~     Evaluation of a one session VR - enhanced Video exposure therapy for dental phobia. Diagnosed~     dental phobics will be randomly assigned to one of two conditions: (1) Psychoeducation + VR~     exposure (2) Psychoeducation + Video Control treatment. Prior to getting the therapy,~     participants will be evaluated with a questionnaire battery, diagnosed with a structured~     clinical interview and will participate in a psychophysiological symptom assessment. Then,~     after a 2-week waiting period, participants again fill in questionnaires, and the~     Intervention will take place. Within 2-weeks after the second questionnaire assessment~     participants will be screened with the structured interview again and will fill in~     questionnaires.~   "
35791|NCT03098121|"~     This clinical study will evaluate whether grazoprevir and elbasvir is efficacious, safe, and~     well-tolerated in peginterferon alfa plus ribavirin experienced patients who inject drugs~     (PWID) and men who sex with men (MSM) with genotype 1 HCV and HIV co-infection.~   "
35792|NCT03098108|"~     The investigators conduct this study to evaluate the efficacy and adverse effect of salvage~     concurrent chemo-proton therapy (CCPT) with or without surgical resection in previously~     irradiated recurrent rectal cancer.~   "
35793|NCT03098095|"~     Physical activity delays all-cause mortality in the general population and reduces the risk~     of cardiovascular disease (CVD), stroke, type-2 diabetes and some types of cancer (Garber et~     al., 2011). These diseases are associated with chronic inflammation, which is characterized~     by activation of inflammatory signalling pathways with abnormal production of cytokines and~     other mediators (Hotamisligil, 2006). Observational studies of large population cohorts have~     consistently shown an association between physical inactivity and low-grade systemic~     inflammation and interventional studies a reduction of inflammatory markers following~     exercise (Beavers et al., 2010).~      Chronic inflammation is also a predominant feature of treated human immunodeficiency virus~     (HIV) infection (Lederman et al., 2013; Deeks et al., 2013). Compared to age-matched~     HIV-negative subjects, persons with chronic HIV infection are at higher risk to develop~     non-acquired immune deficiency syndrome (AIDS) related chronic diseases (Guaraldi et al.,~     2011), and several studies have shown an association between chronic inflammation and higher~     cardiovascular risk and overall mortality (Kuller et al., 2008, Duprez et al., 2012).~      Recently, the investigators performed a pilot study of moderate physical activity that~     enrolled sedentary HIV infected subjects treated with combination antiretroviral treatment~     (cART), consisting of brisk walking, with or without strength exercise. Overall, after 12~     weeks of training cholesterol profile and soluble and cell inflammatory markers improved~     significantly. However, because of the considerable individual variability in exercise~     responses, a program of physical activity needs be adjusted on an individual basis to be most~     effective. During recent years, the use of mobile technologies has been implemented for~     health monitoring interventions, including exercise. We hypothesized that the use of a mobile~     application will favour engagement to exercise by providing motivational inputs, and~     therefore adherence, and, as a consequence, an improvement of physical fitness.~      The investigators hypothesized that the use of a mobile application will favour engagement to~     exercise by providing motivational inputs, and therefore adherence, and, as a consequence, an~     improvement of physical fitness. Therefore, the aim of this project is to improve health and~     quality of life of patients living with HIV through self-empowerment by use of an innovative~     mobile application, in order to assist and monitor individualized program of physical~     activity and diet recommendation.~      OBJECTIVES~      Primary To compare the improvement of physical fitness between the EG and CG groups after 16~     weeks of training.~      Secondary~      To compare the improvement of the following characteristics between the EG and CG groups~     after 16 weeks of training:~        1. anthropometry,~        2. Blood lipids,~        3. Inflammatory markers,~        4. Quality of Life,~      4. Mood State.~      ENDPOINTS Primary The primary objective will be assessed by the proportion of subjects with~     an improvement from baseline of 15% of maximal oxygen consumption (O2max) through 16 weeks of~     training.~      Secondary~      The secondary endpoints will be assessed by the 16-week changes in the following measures:~        1. BMI and %Fat Mass,~        2. Blood Total-, LDL-, HDL-Cholesterol,~        3. Blood IL-6, hs-PCR, d-Dimer, IL-18; myostatin; T-cell activation markers,~        4. F12 questionnaire,~        5. Profile of Mood State questionnaire.~   "
35794|NCT03098082|"~     Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is the most~     common, serious complication of ERCP. More than 500,000 ERCP procedures are performed from~     which 25,000 cases of PEP occur in the U.S.A. annually. PEP accounts for significant~     morbidity and health care expenditures. While symptoms of PEP arise immediately after ERCP,~     they are non-specific. Consequently, unnecessary admissions of outpatients without PEP and~     inadvertent discharge of outpatients with PEP from ERCP recovery are common. An accurate,~     confirmatory test for diagnosis of PEP immediately after ERCP is lacking. Actim Pancreatitis~     (Medix Biochemica) is a urine trypsinogen-2 dipstick test (UTDT) that uses trypsinogen-2 as a~     biomarker for acute pancreatitis. Urine Trypisinogen-2 Dipstick test (UTDT) is a simple,~     inexpensive test with promising preliminary data for accuracy for immediate diagnosis of PEP.~     Prior studies of ITDT test characteristics lack rigorous scientific design. Investigators~     will enroll 1825 ERCP outpatients at our institution in a prospective cohort study. A~     pre-ERCP UTDT test and diagnostic UTDT 2 hours after the ERCP will be performed. Patients~     with a positive baseline UTDT will be followed clinically as part of this study without 2~     hour testing. Care providers and study primary investigators will be blinded to the 2 hour~     UTDT results. Baseline, intra-procedure and recovery room clinical data will be recorded.~     Diagnosis of PEP will be made blinded to the UTDT result. Admission status for PEP will be~     assessed by review of records and phone/e-mail contact 5 days and 30 days after ERCP~     procedure. Sensitivity and specificity of 2 hour post ERCP UTDT for the diagnosis of PEP will~     be calculated.~      Aims: 1) To determine the test characteristics of UTDT for the diagnosis of PEP 2 hours after~     completion of ERCP. 2) To identify and describe patients with baseline UTDT positivity, in~     whom this test offers limited utility.~      Specific Aims:~      Primary Aim 1.1 To determine the test characteristics (sensitivity and specificity) of the~     UTDT for the diagnosis of PEP:~      Hypotheses:~        1. UTDT is a sensitive and specific test for the diagnosis of PEP for patients undergoing~          ERCP.~        2. At a cutpoint for a negative test of <50ug/L, UTDT will be accurate at 2 hours post ERCP~          in patients whose baseline test is negative.~   "
35795|NCT03098069|"~     This implementation research aims to accelerate effective and high coverage of Kangaroo~     Mother Care in district Sonipat in the state of Haryana, India. The project is being led by~     government of Haryana. KMC units will be set up in selected government and private delivery~     facilities. KMC will be initiated for all babies with birth weight less than 2000 gm in the~     facilities (either in born or referred from elsewhere) and continued at home post discharge.~     These babies may be either born in the facility or referred to the facility. A linkage with~     community health workers will be established to support mothers to continue KMC at home.~   "
36091|NCT03094195|"~     To characterize dose response, and evaluate safety and efficacy of three different doses of~     EMA401 compared to placebo in patients with post-herpetic neuralgia (PHN)~   "
35797|NCT03098043|"~     In light of the widespread organ shortage, dynamic preservation by means of Machine Perfusion~     (MP) has been proposed as a strategy to increase the pool of suitable grafts for liver~     transplantation. Reproducing more physiological conditions than traditional Static Cold~     Storage (SCS), MP may allow a better preservation and evaluation and perhaps even the~     resuscitation of high risk grafts. As a consequence, unnecessary discard of organs could be~     avoided and quality and safety of transplantation could be improved as well.~      Hypothermic MP (HMP) seems to reduce ischemia-reperfusion injury. In fact, hypothermia slows~     down the metabolic rate and the oxygenation of the perfusate leads to re-synthesis of~     Adenosine TriPhosphate (ATP), which results in the restoration of cellular energy.~      Four series about the use of HMP in the clinical setting has been published so far. They all~     report acceptable outcomes after transplantation of human liver grafts from extended criteria~     Brain Dead Donors (BDD) and from Donation after Circulatory Death (DCD) donors preserved by~     HMP, thus proving its feasibility and safety. The efficacy of HMP, instead, is still under~     investigation in a phase II randomized trial.~      This is an observational, prospective, monocentric study aiming at verifying the feasibility~     and safety of post-SCS Hypothermic Oxygenated PErfusion (HOPE) in the setting of our liver~     transplant program. Extended criteria grafts from BDD and grafts from DCD donors will be~     preserved by post-SCS HOPE prior to transplantation. The recipients of these grafts will be~     followed-up for at least 1 year.~   "
35798|NCT03098030|"~     This is a 2-part, multicenter, open-label, randomized study of dinutuximab and irinotecan~     versus irinotecan alone in subjects with relapsed or refractory small cell lung cancer~     (SCLC). Part 1 of the study involves intrasubject dose escalation to evaluate the safety and~     tolerability of dinutuximab in combination with irinotecan. Part 2 of the study is designed~     to determine whether dinutuximab plus irinotecan prolongs overall survival (OS) compared with~     irinotecan alone. Subjects in Part 2 will be randomized in a 2:2:1 fashion to 1 of 3~     treatment groups: (A) irinotecan; (B) dinutuximab plus irinotecan; or (C) topotecan.~     Randomization will be stratified by duration of response to prior platinum therapy~     (relapse-free period <3 months or ≥3 months).~   "
35799|NCT03098017|"~     Carbohydrate-based products can influence the post-prandial glycemic response differently~     based on their ability to be digested, absorbed and to affect rises in plasma glucose. Pasta~     is one of the major carbohydrate-rich foods consumed in Italy. Studies from the literature~     describe a lower glycemic response after the consumption of pasta compared with other~     wheat-based products, such as couscous. Among the factors affecting post-prandial glycemia~     after consumption of carbohydrate-based products, the technological process represents a~     central one. In fact, the different technological processes alter the food matrix which can~     affect the post-prandial metabolism of glucose and insulin differently. Thus, the present~     study aims at investigating the effect induced by the principal steps of the process of pasta~     production on the reduction of post-prandial glycemic and insulinemic responses compared to a~     similar durum wheat based product, couscous.~   "
35800|NCT03098004|"~     This behavioral pharmacology laboratory experiment will assess whether sweet (vs. non-sweet)~     flavored e-cigarette solutions reduce tobacco withdrawal symptoms and motivation to smoke~     among 40 smokers interested in trying e-cigarettes (for the first time) following 16-hours of~     nicotine abstinence. The study's experimental design will provide evidence of the causal~     effects of e-cigarette flavorings on a putatively critical factor for determining whether~     smokers continue e-cigarette use after initial trial—the ability of a product to suppress~     withdrawal and motivation to smoke during periods of tobacco deprivation.~   "
35801|NCT03097991|"~     This R01 tests through RCT methodology efficacy of a new intervention designed specifically~     to aid development of positive coparenting alliances between at-risk (unmarried, uncoupled,~     low income) African American mothers and fathers having a first baby together.~   "
35802|NCT03097978|"~     Targeted Muscle Reinnervation increases the control signals available for commercial arm~     systems. A new type of control, pattern recognition, has been developed into a form that~     allows use with commercially available arm system. The goal of this project is a home trial,~     in which people who have had TMR will try the new controls and the new arm to find out if~     they are better than what is currently available. Home trials will also allow us to see what~     needs to be done to make our inventions work even better.~   "
35803|NCT03097965|"~     The study evaluated and compared the safety, tolerance and acceptability of a lifestyle~     modification program with or without nutritional supplementation in generally healthy~     overweight subjects with cardiometabolic risk factors.~   "
35804|NCT03097952|"~     Hepatitis B virus (HBV) infection remains one of the most serious health problems worldwide.~     Patients with chronic HBV infection are at an increased risk for developing hepatic~     cirrhosis, hepatocellular carcinoma and even death. Although some predictive factors of the~     outcome of chronic HBV infection were identified, more precisely determine the factors which~     are associated with the outcome in non-selected patients with chronic HBV infection are still~     needed. The investigators purpose is to constitute a observational cohort of non-selected~     Chinese patients to create a database of epidemiological, clinical, biological, virological,~     immunologic and therapeutic parameters, in order to determine factors associated with the~     outcome of chronic HBV infection.~   "
35805|NCT03097939|"~     The purpose of this study is to test the hypothesis that a combined Immuno-Oncology (IO)~     strategy would see efficacy in a virally driven cancer like Nasopharyngeal Carcinoma (NPC).~     Hence, this is a combination study of nivolumab and ipilimumab in Epstein-Barr virus (EBV)~     driven nasopharyngeal carcinoma.~   "
35806|NCT03097926|"~     The aim of this study was to determine if Biliopancreatic Diversion with Duodenal Switch~     (BPD-DS) with a longer strict alimentary limb at the expense of a shorter biliopancreatic~     limb will offer significant weight lost, but with lesser gastrointestinal complaints, protein~     deficiency, vitamin and trace element deficit compared to standard BPD-DS.~   "
35807|NCT03097913|"~     To investigate the double curve endotracheal tube safely navigate through nasal cavity under~     guidance of a video-stylet.~   "
35822|NCT03097718|"~     This project aims to elucidate neural correlates of proprioceptive deficits in patients with~     recurrent non-specific low back pain, by studying whether brain activation patterns during~     the processing of proprioceptive signals from the ankle muscles and lower back muscles are~     altered compared to healthy control subjects.~   "
35808|NCT03097900|"~     Postoperative ileus is a frequently occurring surgical complication. It is defined as~     temporary inhibition of propulsive bowel activity and is manifested by abdominal distention,~     nausea, vomiting and diet intolerance. It may lead to a prolonged hospital stay,~     hospital-acquired infections or complications that may require additional treatments (e.g.~     analgesia, fluids, electrolyte replacement, nasogastric tube decompression), and as a result~     increase medical costs.~      Previous studies showed that postoperative coffee consumption shortens the time to first~     bowel movement after colorectal resections. However, none could explain the mechanism by~     which coffee stimulates intestinal motility and the determinant agent for this action is~     still up for discussion (either caffeine or another coffee component).~      Coffee has a negligible caloric content; It has a pH that varies from 5 to 6 (less acidity~     than other beverages that have no similar effect on bowel motility) and it is hypotonic.~     Therefore, it is highly unlikely that bowel motility is due to the physical properties of the~     coffee. Much more likely, that one (or more) of the numerous phytochemicals of the coffee~     bean are responsible for this effect, when the most obvious candidate seems to be caffeine.~     However, as mentioned above, very little evidence exists that caffeine was responsible for~     the observed effect on colonic function in previous studies.~      The purpose of this single-centered, prospective, single blinded, randomized clinical trial~     is to evaluate whether the use of caffeine in the post-operative period significantly reduces~     the duration of postoperative ileus, and therefore, improves recovery and shorten the~     hospital stay.~      The study hypothesis is that post-operative use of caffeine will reduce time to recovery of~     GI function (post-operative ileus) by at least 15 hours and thus reduce hospital length of~     stay by at least 15 hours in patients undergoing elective colorectal operations.~      50 patients due to undergo large bowel resection via laparotomy or laparoscopy will be~     enrolled and randomized (1:1) to those who will receive caffeine (100 mg 3 times per day) and~     those who will receive placebo (tap water) starting on the morning of postoperative day 1~     after surgery until flatus will occur for the first time or to a maximal period time of 7~     days, whichever comes earlier.~   "
35809|NCT03097887|"~     This proposed trial is designed to answer the following questions: First, is biliary reflux~     to the distal esophagus present before OLGB and does it increase after the procedure? Second,~     does performing an OLGB with or without anti-reflux sutures make a difference in (biliary)~     reflux exposures of the distal esophagus? To answer these questions the investigators plan to~     perform a randomized, controlled trial involving two groups. Group A will undergo an OLGB~     without anti-reflux sutures and consists of 50 patients. Group B will receive an OLGB with~     anti-reflux sutures and also consists of 50 patients.~      Gastroscopic evaluation for inflammation and reflux will be performed before and one year~     after the operation utilizing multilevel intraluminal impedance pH-monitoring (MII-pH) and~     intragastric Bilitec 2000™. Furthermore, the study will be blinded to the patient. Long-term~     weight loss, the resolution of comorbidities and the incidence of surgical complications will~     serve as secondary endpoints. Follow-ups will be performed at 3, 6, and 12 months~     postoperatively to assess all primary and secondary goals.~   "
35810|NCT03097874|"~     The investigators are conducting a randomized controlled trial using an adaptive design for~     adolescents (ages 12-18) with anorexia nervosa to compare standard Family Based Treatment~     (FBT) to adaptive FBT with an Intensive Parental Coaching (IPC) component. If participants do~     not reach expected milestones by session 4 of treatment, participants may be randomized to~     receive additional IPC or continue treatment as usual with regular FBT.~   "
35811|NCT03097861|"~     To evaluate the bioequivalence of sprinkle and capsule formulations of lubiprostone, as~     compared to placebo, when administered orally in subjects with CIC.~   "
35812|NCT03097848|"~     Radiofrequency ablation is a popular treatment for recurrent hepatocellular carcinoma~     (HCC),but still has a higher recurrence. Sorafenib as neo-adjuvant therapy in combination of~     RFA was not reported yet. There's a theoretical advantage of this combination. Hence in this~     study the efficacy and safety of pre-administrative Sorafenib and Latter radiofrequency~     ablation (RFA) in Recurrent HCC will be tested in a multicenter prospective cohort study.~   "
35813|NCT03097835|"~     The purpose of this study is to comprehensively investigate and objectively demonstrate the~     effectiveness of hyperdiltue Botox® Cosmetic in improving overall skin quality, more~     specifically evenness of skin tone, reduction of pore size and improvement in the appearance~     of preexisting skin scars.~   "
35814|NCT03097822|"~     Response Prediction after Gamma Knife Surgery (GKS) in Patients with Vestibular Schwannoma~     using Dynamic Contrast-Enhanced (DCE) MR Imaging~   "
35815|NCT03097809|"~     Using the novel analysis of stereo-electroencephalography (SEEG) recordings, this proposal~     will investigate the activity and connectivity of mood regulation circuits in subjects with~     suspected epileptic focus who have undergone SEEG electrode implantation for monitoring of~     seizure activity.~   "
35816|NCT03097796|"~     Subjects with hematologic malignancies or recipients of a first allogenic or autologus~     hematopoietic stem cell transplant, without any evidence or respiratory infection, will~     receive 4 doses of PUL-042 Inhalation Solution over a 2 week period. Subjects will be~     evaluated for tolerability of the drug. If tolerated, dose escalation may occur with up to 4~     dose levels tested~   "
35817|NCT03097783|"~     This is a randomized, multi-center, evaluator-blinded, no-treatment controlled study to~     evaluate the efficacy and safety of Restylane Perlane Lidocaine for correction of Midface~     Volume Deficit and/or Midface Contour Deficiency.~   "
35818|NCT03097770|"~     RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory~     into patient autologous or donor-derived T cells may make the body build immune response to~     kill cancer cells.~      PURPOSE: This clinical trial is studying genetically engineered lymphocyte therapy in~     treating patients with B-cell leukemia or lymphoma that is relapsed (after stem cell~     transplantation or intensive chemotherapy) or refractory to chemotherapy.~   "
35819|NCT03097757|"~     The primary objective of this study is to assess the utility of ultrasound guidance in the~     closed reduction of pediatric forearm fractures in the pediatric emergency department. The~     investigators will compare post-reduction radiologic outcomes between the experimental group~     (ultrasound guided closed forearm fracture reduction) and control group (standard of care~     blinded closed forearm fracture reduction) to determine if there is a difference in the~     number of adequate reductions between groups.~      Secondary objectives include comparing provider satisfaction with the reduction procedure,~     number of patients requiring repeat reductions, time for reduction, number of patients~     requiring operative repair after reduction, with the reduction procedure and comparison~     between post-reduction ultrasound and x-ray interpretation.~   "
35820|NCT03097744|"~     This is a retrospective study of meniscal tear repairs at least one-year post repair status.~     All patients were treated with Ceterix NovoStitch devices. The primary objectives of this~     study are to assess the clinical repair success rate via reoperation and PROs at greater than~     12 months.~   "
35823|NCT03097705|"~     The effect of Steep Trendelenburg position used during laparoscopic surgery on intraocular~     pressure during surgery and on the retinal nerve fiber thickness after surgery~   "
35825|NCT03097679|"~     The objective of the BIOFLEX-COF trial is to investigate differences in formation of intimal~     hyperplasia at one and two years after implantation of nitinol-stents with high vs. low COF~     in de-novo femoropopliteal occlusive lesions in patients with symptomatic peripheral arterial~     disease.~      The BIOFLEX-COF trial is a prospective, randomized controlled trial. 80 subjects will be~     enrolled and randomly assigned to either a high COF group (LifeStent Vascular Stent) or low~     COF group (Pulsar).~   "
35826|NCT03097666|"~     The primary objective is to determine the safety and efficacy of the C2 CryoBalloon™ Swipe~     Ablation System (CryoBalloon Swipe) used at increasing doses.~   "
35827|NCT03097653|"~     The present study aim to assess the effect of an interactive web decision aid on informed~     choice - measured via knowledge, attitudes and intentions concerning breast cancer screening~     - comparing the decision aid with a standard information provided via web.~   "
35828|NCT03097640|"~     This study evaluates the clinical outcomes of a novel program designed to target patients who~     are high-utilizers of hospital services. Patients who are frequently admitted to medical~     services - high-utilizers - present a unique set of challenges to providers and the health~     care system that require a different way of approaching chronic illness. The Complex High~     Admission Management Program (CHAMP) is an innovative model of care consisting of a small~     team of providers who establish continuity relationships with high-utilizer patients. CHAMP~     strives to provide effective, high value care via a longitudinal relationship-based care~     model through provider continuity, intensive case management, and personalized care plans. To~     better understand the potential outcomes of CHAMP, this study is a longitudinal, prospective,~     randomized, controlled trial of medical high-utilizers enrolled in CHAMP compared to a group~     of high-utilizer patients receiving usual care.~   "
35829|NCT03097627|"~     This is a clinical trial to evaluate the intravenous administration of indocyanine green~     (ICG) as a method of intra-thoracic lesion localization. The primary purpose is to determine~     if intravenous ICG allows us to identify intra-thoracic lesions.~   "
35830|NCT03097601|"~     Metastatic renal cell carcinomas (mRCC) are highly angiogenic tumors because of mutation of~     the pVHL gene leading to over-expression of VEGF. Therefore, mRCC represent a paradigm for~     the use of anti-angiogenic treatments targeting the VEGF/VEGFR pathway. Despite an increase~     of the time to progression these treatments, taken alone, are not curative with ineluctable~     progression especially for the reference treatment sunitinib a multi kinase inhibitors of~     VEGF, PDGF, CSF1 receptors and c-kit, FLT3 and RET. At progression on sunitinib, patients~     received mTOR inhibitors which is responsible, at least, of HIF1A mRNA translation, then on a~     third line sorafenib that inhibits VEGFR2, 3 PDGFR, c-KIT and B-RAF. The access to these~     different lines of treatment has finally prolonged survival but this situation is not~     satisfactory. Unexpected aspect associated with the use of anti-angiogenesis treatments was~     the diversity of the patients' response. Some patients are right away refractory and die~     rapidly, but the majority of patient has a transient response then progress and a few~     percentages of them are responder for a very long period of time. By only targeting normal~     endothelial cells and tumor neo-vascularization, the response should have been more~     homogenous, thus highlighting that the treatment induced a Darwinian adaptation of tumor~     cells and cells of the microenvironment. Two conclusions follow from these observations: 1-~     The need to identify predictive markers of efficacy; 2-The identification of druggable~     targets participating in progression on anti-angiogenic treatments. Our results have~     highlighted the ELR+CXCL cytokines, pro-inflammatory and pro-angiogenic cytokines as~     prognosis markers of survival of mRCC patients and relevant therapeutic targets on~     experimental tumors in mice. As VEGF/VEGFR, these cytokines are produced by tumor,~     endothelial and inflammatory cells. Their receptors (CXCR1, 2) are expressed physiologically~     by immune and endothelial cells and aberrantly by tumor cells generating at the same time~     autocrine proliferation loops, chronic angiogenesis and inflammation. Therefore, the~     CXCL/CXCR1,2 axis constitutes an independent axis of cancer development and propagation.~     However, the current standard of care is to administer anti-angiogenic therapies as the first~     line treatment. The objective of this project is linked to the identification of potent~     predictive markers of efficacy, easily measured in plasma samples. Deciphering the molecular~     mechanisms associated with the production of such cytokines by tumor cells and by cells of~     the microenvironment represents an interesting intellectual challenge and a relevant way to~     improve the current treatments by targeting, at progression on the current standard of care,~     other pathways than the VEGF/VEGFR axis.~   "
35831|NCT03097588|"~     This phase II trial studies how well netupitant and palonosetron hydrochloride work in~     preventing chemotherapy induced nausea and vomiting in patients with cancer undergoing the~     BEAM conditioning regimen before stem cell transplant. Chemotherapy, such as carmustine,~     cytarabine, etoposide, and melphalan (BEAM), makes people feel sick to their stomach and~     causes vomiting. Netupitant and palonosetron hydrochloride may reduce the nausea and vomiting~     caused by the BEAM treatment.~   "
35832|NCT03097575|"~     This is a clinical trial to evaluate the use of peritumoral injection of near-infrared dye~     indocyanine green to identify lung lesions and sentinel lymph nodes. The primary purpose is~     to determine if the use of ICG injected via navigational bronchoscopy, CT-guided or~     transthoracic allows us to identify the first lymph node that drains from the tumor, and thus~     would be the most likely site for metastatic disease, and remove it for analysis to improve~     the ability to detect tumor in this node and to remove this additional site that potentially~     contains tumor cells. Using this intraoperative imaging technique, we aim to improve the~     identification of lung nodules for resection and the intraoperative identification of~     sentinel lymph nodes in the event that a lymphadenectomy is performed.~   "
35833|NCT03097562|"~     This study is the long term analysis of two types of FSL 3-plane corneal wound profiles,~     namely CT1 and CT2 obtained after a FSL cataract surgery.~   "
35834|NCT03097549|"~     The purpose of this study is to determine whether a comprehensive treatment programme for~     self-management of mixed and urgency urinary incontinence via a mobile app is effective.~   "
35835|NCT03097536|"~     Patients with migraine often report that stressors such as skipping a meal can bring on a~     migraine whereas some patients report that their migraine improves with food. Few studies to~     date have looked at the relationship between blood glucose (sugar) and migraine. We are~     conducting this study to better understand whether or not changes in blood glucose levels can~     trigger migraine or provide relief during a migraine attack.~   "
35836|NCT03097523|"~     This is a feasibility study to determine optimal thigh cuff design using a cephalad fluid~     shift protocol in patients who have an intraventricular catheter (such as Ommaya reservoir)~     placed for the delivery of central nervous system chemotherapy or for diagnosing potential~     elevation of ICP and monitoring its progression as part of standard medical care.~   "
35837|NCT03097510|"~     This randomized controlled trial evaluated the impact of the Transcendental Meditation~     program on emotional intelligence and perceived stress in supervisors and administrative~     staff in a public school system~   "
35860|NCT03097211|"~     The purpose of this study was to determine whether the administration of BIA 6-512 (25 mg, 50~     mg, 75 mg and 100 mg) at steady-state affects the pharmacokinetics of levodopa when~     administered in combination with a single-dose of immediate release levodopa/benserazide~     200/50 mg or with a single-dose of immediate release levodopa/benserazide 200/50 mg plus a~     single-dose of nebicapone 150 mg.~   "
35838|NCT03097497|"~     Hypothesis: The hypothesis of the study is that the physiotherapeutic re-education of the~     pre-activation of the transverse abdominal muscle decreases pain intensity in patients with~     chronic non-specific low-back pain by at least 30% and is more effective than conventional~     treatment.~      Aims: the principal aim is to determine the effectiveness of a physiotherapeutic re-education~     program based on the pre-activation of the transverse abdominal muscle on pain intensity in~     adult patients diagnosed with chronic non-specific low-back pain compared to conventional~     treatment in a primary care setting. The secondary aims of the study are to assess the~     effects of a physiotherapeutic re-education program based on the pre-activation of the~     transverse abdominal muscle on: (1) disability and limitations for the development of the~     activities of daily living associated with LBP, (2) transverse abdominal muscle muscle~     contraction, (3) to assess whether the resistance training parameters applied to older adults~     are valid for young adults and (4) to determine whether the training protocols used for the~     cervical spine could be extrapolated to the lumbar spine.~   "
35839|NCT03097484|"~     Determine the effectiveness of lavender and chamomile aromatherapy of mitigation of symptoms~     of Neonatal Abstinence Syndrome~   "
35840|NCT03097471|"~     Post-market prospective clinical study with a medical device. Data from patients that~     routinely receive a primary BPK-S-integration knee implant made of ceramic will be documented~     with a follow-up time of 2 years.~   "
35841|NCT03097458|"~     A parental cancer diagnosis challenges the family's stability and the parent-child~     relationship. It may impact the children's well-being, so that about one third of them~     develop clinically relevant levels of psychological distress. Psycho-oncological family-based~     counselling programs have been shown to elevate children's and parents' well-being. However,~     there is still a dearth of familial health services in Switzerland, which has also been~     recognized by the Swiss National Cancer Program (2011-2017).~      This study aims to implement and evaluate a short-term family counselling intervention at the~     Cancer Center of the University Hospital Basel. The primary objective of the study is the~     enhancement of adjustment to the parental cancer diagnosis. The study seeks secondary to~     determine the feasibility of the short-term counselling Intervention.~   "
35842|NCT03097445|"~     This study will perform a 5-year follow-up survey of participants in a randomized controlled~     trial that evaluated the effectiveness of providing 5 weeks of free NRT (in the form of the~     nicotine patch) by expedited postal mail without behavioural assistance to regular adult~     smokers recruited across Canada interested in receiving it (clinicaltrials.gov Identifier:~     NCT01429129).~   "
35843|NCT03097432|"~     This prospective open multi-centre non-interventional study initiated to document the~     up-dosing period of children and adults with allergic rhinoconjunctivitis and/or allergic~     asthma treated with a SLIT containing purified, aqueous extracts of birch, alder, and hazel~     pollen. The following up-dosing schemes are freely selectable: scheme A consists of an~     up-dosing period of 12 days at the patient´s home using the standardized pollen extract in~     three different solution strengths to reach the maximum dose; scheme B is performed only with~     the highest solution strength at the physician's office within 2 hours; and the new scheme C~     which is a regimen for initiation at the physician`s office and continuation at the patient`s~     home also exclusively using the highest solution strength and takes 4 days. Data are~     documented by physicians and in patients´ diaries.~   "
35844|NCT03097419|"~     The purposes of the study are to 1) study alterations in the metabolomic profile of patients~     exposed to post-ischemic conditions and 2) study alterations in myocardial infarction size of~     patients exposed to post-ischemic conditioning.~   "
35845|NCT03097406|"~     This study aims to investigate the shoulder function of patients with osteoarthritis or a~     fracture of the upper extremity after surgery with the Global Unite shoulder system.~      The majority of fractures of the humerus are non-surgically treated, but for the complex~     cases where the fracture is irreparable (1), the treatment choice is a shoulder prosthesis~     called a hemiarthroplasty. Hemiarthroplasty has been associated to less pain and more quality~     of life , (2,3) but no difference in range of motion is reported when compared to~     non-surgically treatment of complex humeral fractures. (2,3,4)~      One of the important steps in surgery of a fractured humerus is the fixation of the bone~     fragments in an anatomically correct position as previous studies have shown that~     complications related to the fixation and healing of bone fragments occurred in 11 % of~     patients treated with a hemiarthroplasty . The Global Unite hemiarthroplasty introduces a new~     feature, which allows the surgeon to more closely attach the bone fragments.~      Patients with osteoarthritis and fractures of the humerus will be included from two~     hospitals, Herlev and Køge University Hospital. A total of 88 patients, 44 osteoarthritis and~     44 fracture patients, are included. The patients will be followed two years after surgery and~     will be seen a total of four times postoperatively, where the function of the shoulder will~     be examined by questionnaires concerning shoulder function and quality of life, by a motion~     examination and by x-ray. The outcome of these examinations will be compared to the~     functional outcome of patients that have received different shoulder prostheses for the same~     diagnoses at Herlev and Køge University Hospital. The patients will undergo two radiographic~     scans after surgery, to determine whether or not bone fragments remain in an anatomically~     correct position in the patients with a fracture of the proximal humerus. A special focus~     will be on the function of the shoulder in patients with bone fragments that are not in an~     anatomically correct position. Furthermore, complications and the need of reoperation were~     registered during the two-year follow-up period.~      The aims of this study is to~        -  Determine the function of the shoulder in patients receiving the Global Unite prosthesis~          due to either osteoarthritis or fracture of the humerus.~        -  To compare these results with results from patients previously treated with a different~          prosthesis designs~        -  To determine the influence of the fixation of bone fragments in the postoperative~          function in fracture patients.~   "
35846|NCT03097393|"~     The aim of this study is to examine if procalcitonin (PCT) can be used for early prediction~     of AKI septic patients in ICU.~   "
35847|NCT03097380|"~     An open-label study using positionemissiontomography (PET) to explore the binding of AZD2115~     and Tiotropium to muscarinic receptors in the lungs in healthy volunteers after inhalation.~   "
35848|NCT03097367|"~     To investigate the relationship between post-operative bladder neck levels and urodynamic~     parameters and their effect on urinary incontinence after laparoscopic radical prostatectomy~     (LRP). Forty-eight consecutive patients undergoing LRP were retrospectively reviewed. All~     patients had investigated by retrograde cystography after LRP and were grouped according~     their bladder neck position: Level 0: bladder neck at or above the superior margin of the~     symphysis pubis (SMSP), Level -1: bladder neck at <2 cm below SMSP, and Level -2: bladder~     neck at >2 cm below SMSP. Urodynamic studies were carried out at baseline, 3 and 6 months~     post-operatively. Early recovery of urinary continence was defined as no urine leakage or~     only one pad/day used within 3 months after surgery. Demographic characteristics, changes of~     urodynamic parameters and continence outcomes were analyzed.~   "
35861|NCT03097198|"~     The purpose of this study is to determine whether plum-blossom needle is effective in the~     treatment of juvenile myopia and compare the efficacy with Tropicamide Eye Drops.~   "
35862|NCT03097185|"~     Analyze inflammatory markers and islet graft function through blood samples collected from~     subjects with chronic pancreatitis who undergo total pancreatectomy with auto islet~     transplantation.~   "
35849|NCT03097354|"~     Alcohol consumption is a prevalent behavior in Western societies, which may produce feelings~     of happiness and sociability, but also increases the risk of individual and societal~     detriments. A detailed knowledge about individual and region-specific alcohol consumption is~     crucial in many aspects of health systems, from general practitioner's diagnostic evaluation~     to decisions on health-care related fundings for prevention programs by legislative and~     executive councils.~      The assessment of alcohol consumption often consists of questions like What alcohol and in~     which amount did you drink lately? which may be answered using a given list of prevalent~     alcoholic beverages. With this study, the investigators want to contribute to the~     understanding of psychological determinants in answering these questions. For example, it is~     not yet fully understood, to which extend and why certain beverages are assigned to one of~     several beverage groups. The investigators suspect that familiarity with specific beverages~     as well as product names may influence this assignment.~      In this online survey, which is open to any German-speaking alcohol user no matter how often~     or how much alcohol one normally consumes, participants will be presented a list of common~     beverages (e.g. Cuba Libre, Prosecco, Weizen) and asked to assign these beverages to one of~     several beverage groups (e.g. whiskey, beer, sparkling wine).~   "
35850|NCT03097341|"~     The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and~     pharmacodynamics of xisomab 3G3 in healthy adult subjects.~   "
35851|NCT03097328|"~     This research study is investigating a drug as a possible treatment for metastatic renal cell~     carcinoma. The intervention involved in this study is TAK-228.~   "
35852|NCT03097315|"~     Open-label safety study of suprachoroidal triamcinolone acetone injectable suspension in~     patients with non-infectious uveitis.~   "
35853|NCT03097302|"~     To analyze the effect of femtolaser-assisted keratotomy on corneal astigmatism (anterior,~     posterior and Total corneal refractive power) measured by Scheimpflug tomography after laser~     lens surgery.~   "
35854|NCT03097289|"~     The purpose of this study is to evaluate the quality of platelets collected on the Trima~     Accel system after storage for 5 days in a Platelet Additive Solution (PAS), called InterSol.~   "
35855|NCT03097276|"~     Anastomotic fistula is the most feared complication after surgical resection of colorectal~     cancer (CCR). It occurs in 6 to 15% of patients. Beyond the risk of death in the immediate~     postoperative period, the pain that it induces, the resources required for its management,~     the need for stomata with a negative impact on patients' quality of life and the prolongation~     of hospitalization, it also has a now-recognized adverse effect on long-term survival.~      The early detection of this complication may limit its impact. C-reactive protein (CRP) has~     proved to be an early, reliable marker of the onset of infectious complications of colorectal~     surgery.~      However, the diagnostic procedure to implement in these patients is not at all codified,~     since this population concerned by systematic CRP assay in the postoperative period is very~     recent.~      The procedures to implement in these patients so that they can obtain the maximal benefit of~     an early diagnosis have not yet been established. An algorithm for the proactive clinical~     management must be drawn up to be able to confirm or rule out the presence of a fistula as~     soon as a high level of CRP is detected, and to propose a quick treatment to ensure that~     patients benefit from this early diagnosis.~   "
35856|NCT03097263|"~     Despite the prevalence of chronic low back pain, functional symptomatology of this disease~     remains poor and treatment decisions are based mainly on subjective data (importance and pain~     tolerance). However, there are some experimental elements that involve objective assessment~     of locomotor capabilities - at forefront objectives which the walking velocity in the~     evaluation of this pathology in terms of severity of functional impairment. Recent evidence~     suggest the effectiveness of physical rehabilitation program for improving patients~     functional capacities and their reintegration in socio-professional life. This retrospective~     study aims to quantify the evolution of the parameters collected during standardized walking~     tests performed before and after rehabilitation program. These patients have systematically~     carry out a comfortable walk test (400m walk test) and a brisk walk test (200m) at the~     beginning and end of their program. Furthermore, a maximal stress test on a treadmill was~     performed before the program in order to detect any cardiovascular events and to allow the~     personalization of the effort level required (target heart rate) during rehabilitation. In~     this study the evolution of the comfortable and fast speed will be collected and compared~     with the stress test data, and other measured parameters (functional score of Quebec, muscle~     Tests Shirado and Sorensen).~   "
35857|NCT03097250|"~     This is a study about the relationship of brain biomarkers with neuropsychological~     functioning in PKU. All participants will undergo MRI spectroscopy, will provide a blood~     specimen and will receive neuropsychological testing.~   "
35858|NCT03097237|"~     The overall aim of this study is to investigate whether a diet rich in rye fiber from~     wholegrain rye, compared to refined wheat, as part of a hypocaloric diet leads to larger~     weight loss and lower body fat content after 12 weeks of intervention. Furthermore the study~     will investigate the effect on appetite as a potential underlying mechanism for differences~     in weight loss and body fat reduction.~   "
35859|NCT03097224|"~     Objectives To investigate the impact of tele-supervised prehabilitation on functional~     capacity in frail colon cancer patients undergoing colorectal resection and to evaluate the~     effects of prehabilitation on muscle strength and endurance, quality of life (QoL), executive~     functions, fatigue and inflammatory and metabolic parameters.~      Methods A randomized controlled trial will be conducted. Patients will be randomised into~     either a prehabilitation group (PREHAB) or a control group. Prehabilitation group will~     participate in a 4-week telerehabilitation before surgery while the control group will~     receive usual care and World Health Organization recommendations on physical activity for~     health before surgery. Program exercise will consist of three moderate-intensity aerobic and~     resistance sessions per week. Subjects will have assessments at baseline, pre-intervention~     and 8 weeks after surgery. The primary outcome will be functional capacity measured by using~     the 6-min walk test. The secondary outcomes will be: physical measurements, QoL, level of~     physical activity, executive functions, fatigue, body composition, blood test, energy~     expenditure.~   "
35875|NCT03097016|"~     Multi-center, open-label, single-dose study to assess the PK of a single oral dose of 3 mg~     CC-122 in subjects with mild, moderate, and severe renal impairment as compared to sex, age~     (± 15 years), and weight (± 20%) matched control subjects with normal renal function.~   "
35863|NCT03097172|"~     This is a single centre observational study on the impact of change in patient position and~     hence gravity, on physiological measurements in coronary arteries.~      When patients present with heart attacks involving completely occluded heart arteries, there~     are signs anecdotally and in literature that arteries sitting higher up with the patient~     lying flat, receive less blood supply than arteries sitting lower down.~      The investigators believe this effect is due to the pull of gravity on the flow of blood~     through the heart arteries. If this is indeed the case, changing position from lying supine~     (patient on their back) to lying prone (patient on their front) could reverse these~     anatomical positions and change measurements obtained during a coronary angiogram. These~     measurements include pressure and flow.~   "
35864|NCT03097159|"~     The investigator will compare Costoclavicular approach of infraclavicular block and~     supraclavicular block. Especially, the incidence of phrenic nerve palsy and the quality of~     block.~   "
35865|NCT03097146|"~     After discharge from hospital, the current healthcare system in Germany allows considerable~     flexibility (therefore complexity) of patient access and mobility between multiple care~     providers in the community setting. The investigators believe this aftercare could be better~     coordinated by a specialized coordinated stroke aftercare service. Comprehensive coordinated~     multidisciplinary care is a proven concept with proven benefits in both acute and~     rehabilitation care provided in stroke units and neurorehabilitation centres. In this study,~     the investigators postulate that a similar coordinated approach to care can be extended to~     the phase after in-patient rehabilitation has ended (i.e. long-term management as opposed~     to early supported discharge) for disabled patients with stroke living in the community.~   "
35866|NCT03097133|"~     The purpose of this study is to evaluate the efficacy of intranasal esketamine 84 milligram~     (mg) compared with intranasal placebo in addition to comprehensive standard of care in~     reducing the symptoms of Major Depressive Disorder (MDD), including suicidal ideation, in~     participants who are assessed to be at imminent risk for suicide, as measured by the change~     from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) total score at 24~     hours post first dose.~   "
35867|NCT03097120|"~     Background: Heart disease is a major cause of illness and death in women. To understand~     better the role of estrogen in the treatment and prevention of heart disease, more~     information is needed about its effects on coronary atherosclerosis and the extent to which~     concomitant progestin therapy may modify these effects.~      Methods: The investigators randomly assigned a total of 309 women with angiographically~     verified coronary disease to receive 0.625 mg of conjugated estrogen per day, 0.625 mg of~     conjugated estrogen plus 2.5 mg of medroxyprogesterone acetate per day, or placebo. The women~     were followed for a mean (±SD) of 3.2±0.6 years. Base-line and follow-up coronary angiograms~     were were analyzed by quantitative methods. Follow-up coronary angiograms were obtained after~     an average of 3.2 years of follow up.~   "
35868|NCT03097107|"~     To evaluate the safety and efficacy of Saroglitazar Magnesium 1, 2, and 4 mg in patients with~     fasting triglyceride ≥500 mg/dL and ≤1500 mg/dL.~   "
35869|NCT03097094|"~     A new male-specific dog-allergen-component has been found (Can f 5) which indicates possible~     differences in allergic reactions to male and female dogs. This has not yet been tested in~     real life.~      The aim is to test if sensitization only to the male-dog specific allergen-component, Can f~     5, results in a positive skin prick test (SPT) to male dog extract and not female dog~     extract. In addition, the investigators want to investigate if allergic symptoms only occur~     when exposed to the male dog extract by conjunctival provocation.~   "
35870|NCT03097081|"~     Rationale: There is no evidence in the current literature regarding the additional value of~     an orthosis after surgically treated thoracolumbar spine fractures.~      Objective: To assess whether an orthosis provides additional pain relief compared to no~     orthosis after posteriorly fixated thoracolumbar spine fractures. Primary outcome is~     difference in pain at six weeks post-operatively. Secondary objectives are pain at other~     moments, pain medication used, pain related disability, quality of life, long-term kyphosis,~     possible complications, hospital stay, return to work and subjective feeling on benefit or~     disadvantage from the orthosis.~      Study design: Randomized controlled intervention study, non-inferiority trial.~      Study population: Dutch speaking patients presented at the VU university medical centre, 18 -~     65 years old with a traumatic thoracolumbar spine fracture from Th7 - L4 surgically treated~     by posterior fixation.~      Intervention: One group receives standard care and wears an orthosis after surgery for 12~     weeks, to use when in vertical position. The intervention group does not wear an orthosis~     after surgery.~      Main study parameters/endpoints: Main study outcome is the difference in pain noted on the~     NRS-score at six weeks, ≥ 2 (SD 2,5) change corresponds with a clinically significant change~     in pain score.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: The current guideline for postoperative care regarding dorsal stabilization of~     spine fractures recommends the use of a post-operative orthosis. While patients generally~     receive an orthosis for 12 weeks, individual surgeon's believes sometimes gives reason to~     deviate from this guideline. This is founded by literature that increasingly questions the~     use of orthoses in the conservative treatment of spine fractures. With the fracture~     operatively stabilized, the orthosis mainly provides support of gesture and thereby~     potentially results in pain relief and confidence for patients. On the other hand some~     patients have a hard time weaning from the orthosis or report discomfort due to the device~     and prefer not to use it. With subjects being randomized between the use of an orthosis or no~     orthosis there is no additional risk. This is in part because it is hypothesized that there~     is no difference in postoperative pain and there might be a lower risk of complications~     related to the orthosis.~   "
35871|NCT03097068|"~     The protocol will measure a number of cytokines in addition to vascular endothelial growth~     factor in response to 0.3mg Lucentis.~   "
35872|NCT03097055|"~     This study will have acupuncture intervention in acute ischemic stroke patients and evaluate~     the effect in neurological function improving by National Institutes of Health Stroke Scale~     (NIHSS), Modified Rankin Scale (mRS), Barthel Index, and antiinflammatory actions by~     biomarkers.~   "
35873|NCT03097042|"~     The embryologist will oad the embryos into the catheter at the right position, then the~     catheter will be slowly pushed through the cervical canal, 1-2 cm beneath the fundus 5.5 cm~     away from the cervical external os.The embryos will be delivered by pushing the plunger of~     the syringe from the mid-cavitary positioned catheter and keeping the plunger pushed down.~      Study Group: The catheter will be pulled back slowly and without rotation with the plunger~     still pushed forward.~      Control Group: The catheter will be pulled back slowly with a 360°rotation with the plunger~     kept pushed forward.~   "
35874|NCT03097029|"~     Patients with short bowel syndrome have a high mortality rate that is mainly attributed to~     complications from central lines and long-term intravenous (IV) nutrition. There are few~     medical therapies to date that improve gut absorption in patients with short bowel syndrome.~     The primary objective of this study is to evaluate if absorption from the GI tract improves~     in subjects with short bowel syndrome following therapy with pancreatic enzymes.~   "
35905|NCT03096626|"~     This study assesses the association of depression symptoms and iron metabolism in patients~     undergoing hemodialysis.~   "
35876|NCT03097003|"~     OTELO is a national (Belgium), multicentre, prospective, non-interventional, post-marketing~     study. The study will include a representative sample of approximately 250 patients with~     moderate-to-severe plaque psoriasis for whom the treating dermatologist has decided to begin~     apremilast treatment in accordance with the local label and reimbursement criteria. Patients~     may be enrolled into the study up to 4 weeks after commencing the study treatment.~      As this study is non-interventional, drug dosing and treatment duration will be at the sole~     discretion of the treating dermatologist, in accordance with the local label and daily~     clinical practice.~   "
35877|NCT03096990|"~     The study will include a representative sample of 150 patients with active Psoriatic~     Arthritis (PsA) for whom the treating rheumatologist has decided to begin treatment with~     apremilast. This study is non-interventional, drug dosing and treatment duration will be at~     the sole discretion of the treating rheumatologist, in accordance with the local label and~     daily clinical practice. APOLO is a national (Belgium), multicentre, prospective,~     non-interventional, post-marketing study.~   "
35878|NCT03096977|"~     This study lies in the continuity of the study with identification number NCT02805634. It~     will be performed on the same group of patients and will aim to assess the manual dexterity,~     in order to better assign kinesitherapy treatments and increase the utilisation capacity of~     the hand.~   "
35879|NCT03096964|"~     Objective: to assess by means of a randomized clinical trial the effects of eight weeks of~     Nordic walking and free walking training on quality of life (QoL), static balance, dynamic~     variability, self-selected walking speed (SWS) and locomotor rehabilitation index (LRI),~     parameters of pendular mechanism [external (Wext), internal (Wint) and total mechanical work~     (Wtot), Recovery (R), Cost of Transport (C)], Electromyographic parameters (Average signal~     and co-contraction of the Anterior deltoid (AD), triceps brachii (TB), vastus lateralis (VL),~     biceps femoris (BF), anterior tibial (AT) and medial gastrocnemius (MG) muscles, heart rate~     of exercise (HRexercise) - and the rate of perceived exertion (RPE), in sedentary elderly.~   "
35880|NCT03096951|"~     Objectives To investigate the impact of tele-supervised prehabilitation on functional~     capacity in colon cancer patients undergoing colorectal resection for cancer and to evaluate~     the effects of prehabilitation on muscle strength and endurance, quality of life (QoL),~     executive functions, fatigue and inflammatory and metabolic parameters.~      Methods A randomized controlled trial will be conducted. Patients will be randomised into~     either a prehabilitation group or a control group. The prehabilitation group will receive~     tele-supervised prehabilitation for 4weeks and telerehabilitation for 8weeks post-surgery~     while control group will begin telerehabilitation only after surgery for 8weeks. Patients~     will care with an enhanced recovery pathway. Telerehabilitation pre and post-surgery will~     consist of three moderate-intensity aerobic and resistance sessions per week. Subjects will~     be assessed at baseline, pre-intervention, post-intervention and post-rehabilitation. The~     primary outcome will be functional capacity measured using the 6-min walk test. The secondary~     outcomes will be: physical measurement, quality of life, level of physical activity,~     executive functions, fatigue, body composition, blood test, energy expenditure.~   "
35881|NCT03096938|"~     The purpose of this study is to evaluate the role of cell-free DNA methylation markers in~     cancer screening.~   "
35882|NCT03096925|"~     This study aims to test an easily implementable web-based cognitive behaviour therapy (CBT)~     self-help intervention designed for non-cardiac chest pain patients, and compare~     effectiveness and cost-effectiveness to treatment as usual in an randomized controlled trial~     (RCT).~   "
35883|NCT03096912|"~     The purpose of this study is to determine whether ribociclib are effective and safe in the~     treatment of progressive well/dedifferentiated liposarcoma (WDL/DDL).~   "
35884|NCT03096899|"~     The primary objective of this study is to estimate overall survival in patients only~     receiving best supportive care (BSC) for treatment-resistant, metastatic colorectal~     carcinoma. The primary efficacy outcome is overall survival, defined as the time from the~     date of the radiographic scan demonstrating disease progression post available treatments~     (time of origin, T0) to death from any cause.~   "
35885|NCT03096886|"~     The purpose of the study is to learn more about computer-assisted cognitive behavioral~     therapy or CCBT and to examine connections in the brains of patients with depression. CCBT~     is approved by the FDA as a form of treatment for depression. It is done partly on the~     computer and partly with a therapist.~      This study will enroll participants with depression and participants without depression. The~     investigators will recruit a total of 100 participants: 60 with Major Depressive Disorder~     (MDD) and 40 matched comparison participants.~      Healthy control subjects will participate for approximately 8 weeks.~      All MDD participants will receive CCBT. Half of the MDD participants will all receive~     computer-augmented skills training with the Good Days Ahead (GDA) protocol immediately (CCBT~     Immediate). CCBT Immediate subjects will participate for approximately 10-12 weeks. The other~     half of the MDD participants initially will be randomized to an 8-week waitlist and~     subsequently will receive CCBT treatment (Waitlist followed by CCBT). Waitlist followed by~     CCBT subjects will participate for approximately 18-20 weeks.~      All participants are asked to complete a screening, which includes a series of clinical~     interviews and self-report questionnaires about the individual's thoughts, moods, and~     behaviors. All participants are asked to wear an actigraph, which is a watch-like device that~     measures activity levels. Additionally, participants are asked to completed short questions~     and have their activity levels monitored through phone app(s).~      All participants (Healthy Control and MDD participants) will receive functional magnetic~     resonance imaging (fMRI) scanning at baseline. CCBT Immediate participants will receive fMRI~     scanning after 8 weeks of CCBT, and Waitlist followed by CCBT participants will receive fMRI~     scanning at the conclusion of the 8-week waitlist and after the 8-week course of CCBT. Brain~     activity will be compared between MDD and controls at baseline and between CCBT Immediate vs~     8-week Waitlist followed by CCBT. The 2nd and 3rd brain scans of Waitlist followed by CCBT~     participants at the end of the 8-week waitlist and 8-week course of CCBT, respectively, will~     allow within-subject comparison of CCBT vs Waitlist treatment effects.~   "
35886|NCT03096873|"~     The purpose of the study was to observe therapeutic effects of combined resistance and~     aerobic exercise training (CRAE) on hyperinsulemia in obese adolescent girls. Forty obese~     adolescent girls (14±1 years) participated in this study. The participants were randomly~     separated into two groups; no-exercise group (n=20) and exercise group (n=20). The exercise~     group performed 12 weeks of CRAE.~   "
35887|NCT03096860|"~     The purpose of the current study is to investigate in a prospective randomized cross-over~     trial, the impact of alcohol versus a placebo drink on smoking behavior and topography~     (duration and frequency of puffing), abuse liability, and toxicity. It is hypothesized that~     drinking alcohol before smoking will be associated with longer puffs and shorter duration~     between puffs and greater abuse liability and toxicity.~   "
35888|NCT03096847|"~     A national, multi-center, open-label, phase IIIb trial to determine the efficacy and safety~     of treatment with ribociclib (LEE011) plus letrozole in women and men with HR+, HER2-negative~     advanced or metastatic breast cancer~   "
35889|NCT03096834|"~     The purpose of this study is to determine if AMG 334 is effective in treating migraines in~     patients who have unsuccessfully failed other preventive migraine treatments.~   "
35890|NCT03096821|"~     Patients with relapsed/ refractory acute leukemia and relapsed/ refractory aggressive~     lymphoma harboring an activating genetic alteration (gene mutation, gene fusion) or drug-able~     biomarker / activated signal transduction pathway and resistant to any approved treatment~     modality will be eligible for this study.~      The investigators aim to combine DNA sequencing-based molecular profiling with an ex vivo~     high-throughput drug screening strategy. For the latter method, viable cells are obtained~     from the individual patient's lymphoma or leukemia in order to determine i)the expression of~     relevant therapeutic target molecules and ii)the ex vivo response of the patient's cancer~     cells to a panel of agents with anticancer activity. In addition, analysis of tumor stroma~     cells will provide information about the differential target expression and cellular~     sensitivity aiming at the evaluation of a therapeutic safety window. Thereby, biological~     material will have to be accessed within 4 weeks before onset of individualized treatment~     (real-time biopsy). Bioinformatic data-management based on a Bayesian statistical approach~     will support individualized treatment decisions in this controlled clinical approach.~   "
35891|NCT03096808|"~     The purpose of this study is to demonstrate that adaptive radiotherapy (ART) in head and neck~     cancer patients are comparable to historical controls in head and neck patients undergoing~     standard intensity-modulated radiation therapy (IMRT) without ART.~   "
35892|NCT03096795|"~     This is a Phase 1, randomised, blinded, placebo controlled, study designed to evaluate the~     safety, tolerability, pharmacokinetics, and immunogenicity response to single and multiple~     doses of MEDI3506.~   "
35893|NCT03096782|"~     Umbilical cord blood is a source of blood-forming cells that can be used for a transplant.~     The cord blood cells being transplanted in this study will be from a donor. Before the cord~     blood is given to you, researchers will grow the cord blood cells in a laboratory.~      Expanding cord blood means to change the blood in the laboratory. To expand the cord blood,~     researchers will grow the blood cells on a special layer of cells called mesenchymal~     precursor cells (MPCs) collected from the bone marrow of healthy volunteers and grown in a~     laboratory. This is designed to increase the number of expanded cells that can be collected.~     A type of sugar will also be added to the cell membrane of blood cells in the laboratory,~     which may help your blood counts to recover faster.~      As part of standard care, patients normally receive 2 units of non-expanded cord blood.~      The goal of this clinical research study is to learn if giving 1 unit of expanded cord blood~     with added sugar and 1 unit of non-expanded cord blood (no added sugar) to a patient with~     leukemia or lymphoma can help the transplant to take faster. The safety of this combination~     will also be studied. Chemotherapy and/or 1 dose of radiation therapy will also be given~     before the transplant.~      This is an investigational study. Expanded cord blood cells with MPCs and adding sugar are~     not FDA-approved processes. Both processes are currently being used for research purposes~     only. Fludarabine, busulfan, clofarabine, melphalan, mycophenolate mofetil (MMF), tacrolimus,~     and rituximab are FDA approved and commercially available to be given to patients with~     leukemia or lymphoma having a cord blood transplant. Total body irradiation is delivered~     using FDA-approved and commercially available methods. The study doctor can explain how the~     study treatments are designed to work.~      Up to 25 participants will be enrolled in this study. All will take part at MD Anderson.~   "
35894|NCT03096769|"~     This study is designed to answer if an ergonomist can configure a daVinci robot console to~     improve surgeon discomfort. Adjustments to the robot console will be surgeon specific as they~     are tailored to their individual body type. Measurements will be taken at the time of console~     configuration.~   "
35895|NCT03096756|"~     A Phase 1 study will test the safety, tolerability and pharmacokinetics of a single dose of~     GC4702 when given as an oral tablet. This study will compare capsules containing a dry powder~     or gel suspension of GC4702 when given orally to a similar drug called GC4419 which will be~     given as an intravenous infusion. This study will also assess the effect of food on the~     GC4702 effects.~   "
35896|NCT03096743|"~     Investigators will compare magnetic resonance (MR) elastography measurements to other forms~     of noninvasive methods of detecting raised intracranial pressure, including optical coherence~     tomography (OCT) imaging measurements of the retinal nerve fiber layer (RNFL) and indirect~     signs of raised intracranial pressure on magnetic resonance imaging (MRI).~   "
35897|NCT03096730|"~     To explore and compare antihyperalgesic effects of Dexmedetomidine,Nalmefene,and a~     combination of both received before anesthesia induction.~      To evaluate and examine the incidence of adverse effects with the purpose of selecting the~     optimum dose.~   "
35898|NCT03096717|"~     Chronic intestinal inflammation produce dysplasia more frequently than the normal population.~     The therapies protect against these changes, but do not rule out dysplasia. It is not known~     the effect of different therapies protection.~   "
35899|NCT03096704|"~     Vitamine d dosage in important to define nutritional status and bone metabolism. For patients~     with intestinal disorders it is important to establish the intestinal absorptive function.~      It is important to establish the absorption of vitamin D which correlate with different~     biological activity and bone metabolism, immune function and the communication between the~     cells.~   "
35900|NCT03096691|"~     Prematurity is the most important cause of obstetric morbidity and mortality. Health centers~     and obstetricians are trying to reduce the preterm birth rate by taking into account the~     permanent effects of premature birth on human life in the early and long term.~      The most effective solution of preterm delivery is to determine the patients entering the~     risk group and to prevent preterm labor by putting the correct diagnosis at the right time.~     Recently, there have been studies on the efficacy of pessary practice in preventing preterm~     birth, but with the positive results of these studies, there has been hope for early birth~     prevention as well as other treatments.~      The aim of this study is; To assess the effectiveness of pessary use in patients with high~     risk for preterm labor and prophylactic cervical length less than 25 mm below 25 weeks and~     with a history of cervical insufficiency.~   "
35901|NCT03096678|"~     The investigators sought to evaluate the morphological and functional changes, risk~     stratification and prognosis of patients of participants with compete left bundle branch~     block (CLBBB).~      The conduction of this study was largely due to the increased clinical requirement, which~     reflected the increased awareness among physicians of heart failure due to asynchronous~     cardiac function caused by CLBBB. The investigators also aim to figure out the time point or~     CMR parameters for cardiac resynchronization therapy in patients with CLBBB.~   "
35902|NCT03096665|"~     This study aimed to evaluate the correlation between the point of care blood analysis~     obtained from skin puncture blood and conventional blood analysis obtained from venous and~     arterial blood.~   "
35903|NCT03096652|"~     Comparing standard midline approach with the modified approach in management of morbid obese~     patients with gynecologic cancers.~   "
35904|NCT03096639|"~     A randomized clinical trial to investigate the use of the temporary Diaphragm Pacing Therapy~     System (DPTS) to rehabilitate the diaphragm in mechanically ventilated patients who have~     failed at least two weaning attempts. The goal is to strengthen and rehabilitate the~     diaphragm to liberate the patient more quickly from mechanical ventilation.~   "
35906|NCT03096613|"~     Based on accumulating evidence showing that hypothyroid status is associated with poor~     prognosis among heart failure (HF) patients, the study is designed to evaluate whether~     replacement treatment with levothyroxine could have beneficial effects on patients with HF~     and subclinical hypothyroidism. The study is a prospective, randomized, parallel-group trial~     to assess the efficacy and safety of levothyroxine replacement on evidence-based HF standard~     therapy in stable chronic heart failure patients with subclinical hypothyroidism.~   "
35907|NCT03096600|"~     Mini invasive spine surgery have become very common in the past years. Posterior arthrodesis~     associated to liberation have good functional results and doesn't present much complication~     cases.~      So that's why St Joseph Hospital spine surgeon have made the hypothesis that this kind of~     surgery can be associated to fast track surgery.~   "
35908|NCT03096587|"~     Recruited patients with symptomatic irreversible pulpitis are assigned to interventional (XP~     Endo Finisher file) and control group(ultrasonic activated irrigation) to undergo single~     visit endodontic treatment and record postoperative pain afterwards.~   "
35909|NCT03096574|"~     Respiratory Syncytial Virus (RSV) is the leading cause of chest infections (pneumonia and~     bronchiolitis) in young children, and is a major cause of admission to hospital and childhood~     death worldwide. One possible way to protect the mother and young infant from RSV infection~     is a vaccine given to women during pregnancy (maternal vaccination), which would pass~     protection to their unborn child. This may help to prevent RSV in the child's first few~     months of life when they are most vulnerable to infection. With RSV vaccine candidates in the~     pipeline, this study aims to pre-emptively gauge the knowledge of RSV and potential~     acceptability of such vaccines amongst pregnant women and healthcare staff working in~     midwifery and obstetrics, as well as their attitudes (facilitators and barriers) to being~     involved in hypothetical future research trials.~      The investigators propose to undertake a questionnaire-based study of randomly selected~     pregnant women and healthcare staff (over 16 years of age) at four English teaching~     hospitals. Pregnant women attending for ward reviews or antenatal clinics will approached and~     asked to complete an anonymous paper questionnaire lasting around 10 minutes. Healthcare~     staff will be approached in person, or via email, and asked to complete a slightly different~     questionnaire lasting around 5-10 minutes. No follow up will take place. Using statistical~     software, the investigators hope to identify factors that might affect patients'~     understanding of RSV and attitudes to being involved in hypothetical future trials and~     receiving the RSV vaccination~   "
35910|NCT03096561|"~     Serum Potassium Rate (PR) is a key indicator for medical management of patients with~     accidental hypothermia particularly for hypothermia related cardiac arrest (CA).~      Experts recommend a cut-off value for PR of 12 mmol/l for all hypothermic victims and 8~     mmol/l for avalanche casualties. Any patient presenting a PR lower than the cut-off value~     should be considered for Extracorporeal Rewarming. This therapeutic strategy is vital for~     patient survival.~      However, there is no consensus about what type of vessels should be punctured in order to~     obtain an accurate potassium rate and what type of measurement technics should be used to~     measure this potassium rate.~      The investigators hypothesize that potassium rate in these patients will differ by 1 mmol/l~     in blood samples collected from a peripheral vein in contrast to a central vein.~      The investigators study is a prospective observational, multicentre study.~   "
35911|NCT03096548|"~     Over 3.5 million cases of non-melanoma skin cancers occur annually and melanoma rates have~     doubled in the last 30 years, burdening the nation's health system. Klein Buendel, Inc. (KB)~     proposes to develop Sun Safety INK! (SSI!), a skin cancer prevention program targeted to~     clients of licensed tattoo studios because tattoo aftercare recommendations can include sun~     protection for tattoos, and studios offer an opportunity to reach younger adults who are~     significantly more likely to sunburn and less likely to practice sun safety. The study will~     assess the effectiveness of SSI! at (1) increasing full-body comprehensive sun protection~     practices; (2) decreasing sun burning and tanning; and, (3) decreasing positive attitudes~     regarding tanning and tanning attractiveness.~   "
35912|NCT03096535|"~     This study investigates cold-induced brown fat activation assessed using PET/MR scans.~     Subjects will participate in an acute cooling intervention day and a thermoneutral~     intervention day with PET/MR scans on both days. A secondary purpose is to make a validation~     of an infrared thermography camera by comparison of skin temperatures and SUV of the~     supraclavicular brown adipose tissue.~   "
35913|NCT03096522|"~     Patients with anal fistula who will undergo anal fistulotomy will be randomized into one of~     two groups; the first group will receive topical phenytoin therapy postoperatively and the~     second group will not receive such topical treatment.~   "
35914|NCT03096509|"~     Innovations aimed at improving new patient identification, diagnosis, nonpharmacological~     treatment, supported self-management, and remote monitoring, together with new methods of~     clinical support could improve outcomes in patients with respiratory disease. The~     Investigators have developed a model of care incorporating key innovations for patients with~     asthma, COPD and undifferentiated breathlessness. This service is being implemented within~     Wessex CCGs. The investigators will assess whether the implementation of the service is~     effective, and how it can be adjusted, in addition to introducing innovations to assess~     whether the expected benefits for patients are realised.~   "
35915|NCT03096496|"~     This is a prospective and international observational study run by the GIMEMA. All data will~     be centrally collected and analyzed at the GIMEMA Data Center in Rome (Italy). Patients~     reported outcomes will be collected using internationally validated questionnaires.~   "
35916|NCT03096483|"~     The purpose of the study is to collect survey data on the use of the OEC Elite Mobile~     Fluoroscopy System based on the routine clinical use of the device.~   "
35917|NCT03096470|"~     The purpose of this study is to compare the efficacy of closed reduction with anesthesia and~     no anesthesia for developmental dislocation of the hip < 6 months~   "
35918|NCT03096457|"~     This protocol will compare topical paromomycin to standard intralesional (IL) antimony (Sb)~     to placebo for L braziliensis in Bolivia.~   "
35977|NCT03095690|"~     Idiopathic Parkinson's disease (IPD) is the second most frequent neurodegenerative disease.~     Its association with osteroporosis and fragility fracture is now clearly demonstrated, but~     the determinants of this osteoporosis are yet to be explained. Our aim was to study factors~     associated with volumetric bone mineral density (vBMD) and bone microstructure at the tibia~     and radius in IPD.~   "
35919|NCT03096444|"~     The purpose of this study is to examine the antipruritic efficacy of topical ketamine,~     amitriptyline, lidocaine, and a tri-combination of ketamine, amitriptyline and lidocaine~     (hereafter referred to as KeAmLi) using non-histaminergic itch provocations in healthy~     volunteers. The primary outcome is itch reduction (AUC) between the vehicle and active~     treatment (KeAmLi-combo). Secondary outcomes include modality-specific analgesic properties~     of the topically applied ketamine, amitriptyline, lidocaine, and KeAmLi-combo to controlled~     quantitative thermal and mechanical stimuli, which can improve our understanding of the~     mechanism of action of these substances in the context of topical therapy.~   "
35920|NCT03096431|"~     To determine the feasibility of processes and instruments with an overarching purpose to~     guide the design of a larger study. To determine the feasibility of individuals with~     metastatic brain tumor(s) to engage in physical activity(PA) and cognitive rehabilitation~     (CR) as in an outpatient therapy setting.~   "
35921|NCT03096418|"~     The hypothesis of this study is that paclitaxel levels increase chromosomal instability (CIN)~     in tumors and this is lethal to tumors that have pre-existing CIN.~      Treatment will be administered on an outpatient basis. Paclitaxel will be initiated as~     standard infusions on days 1, 8, and 15 of a 1-day cycle. Participants will continue with~     paclitaxel for cycles 2-4 prior to surgery.~   "
35922|NCT03096405|"~     Staphylococcus aureus represents one of the most met germs, with Escherichia coli, during~     bacteremia. Microbiologist distinguish at aureus S. two profiles of resistance in~     beta-lactamines: S. aureus sensitive to the methicillin ( SASM) and the S. aureus resistant~     to the methicillin ( SARM).~      With the implementation of the MALDI-TOF, it is now possible to identify the origin~     responsible of the bacteremia the day of the positivity of the hemoculture ( J0) and to set~     up a treatment with adapted antibiotic, which, in the case of a sepsis to aureus S., is the~     vancomycine. Ye it was demonstrated, that the use of the vancomycine on the SASM increased~     the average duration of stay and a more important rate of relapse.~      The PCR SARM was organized in the GHPSJ in 2014. It allows from the day of the positivity of~     the hemoculture ( J0), to determine the phenotype of resistance of S. aureus.~   "
35923|NCT03096392|"~     Multi-Center, double blind, active comparator controlled multiple dose safety, tolerability~     and efficacy study~   "
35924|NCT03096379|"~     It is clinically challenging to differentiate Crohn's disease from gut tuberculosis~     especially in regions endemic of tuberculosis infection. The investigators plan to perform~     magnetic resonance enterography (MRE) who presented to our hospital in Shenzhen, China for~     new onset of lower gastrointestinal symptoms and ileocecal mucosal lesions of uncertain~     diagnosis as evidenced by the presence of inflammation, ulceration, strictures or nodules on~     colonoscopy. MRE findings will be independently interpreted by two radiologistsThe role of~     MRE in distinguishing gut tuberculosis from Crohn's disease will be determined.~   "
35925|NCT03096366|"~     The purpose of this study is to evaluate the effectiveness of physical therapy (PT) plus BFR~     training compared to PT alone (without BFR training) after ACL reconstruction in patients who~     require extended limited weight bearing through assessment of patient reported outcomes and~     functional testing. The hypothesis is that PT plus BFR training will mitigate the loss of~     quadriceps muscle cross-sectional area, strength, and function while also improving early~     clinical and functional results.~   "
35926|NCT03096353|"~     Background:~      Medicines called opioids are used to treat pain. The body also produces opioids. These are~     called endorphins. Researchers want to learn more about how these natural opioids work. This~     might lead to new therapies for conditions like depression, anxiety, and chronic pain.~      Objective:~      To determine how opioids affect how pleasant or unpleasant it feels when the skin is touched,~     compressed, or heated.~      Eligibility:~      Healthy right-handed adults ages 18 50.~      Design:~      Participants will be screened under another protocol.~      Participants will have 2 study visits with the same procedures, at least 1 day apart. Each~     visit will last 3-4 hours.~      Participants will wear shorts or change into scrubs so researchers can test on their legs.~      Participants will answer questions and have urine tests.~      Participants will have a brain magnetic resonance imaging (MRI) scan. The scanner is a metal~     cylinder in a strong magnetic field. Participants will lie on a table that slides in and out~     of the cylinder. A device called a coil will be placed over the head.~      During MRI, participants will have sensory testing. They will get several types of touch to~     the calf of the leg. These include gentle brushing of the skin, gentle compression of the~     calf with an inflation sleeve, and heat stimuli.~      Participants will have an intravenous line placed each day. They will get naloxone 1 day and~     saline the other day. Participants will not be told which they get. Naloxone is a drug that~     blocks opioid receptors.~      The MRI and sensory testing will then be repeated.~      After each stimuli block, participants will rate the sensations as well as their mood and~     calmness/anxiety.~   "
35927|NCT03096340|"~     IT141 is a novel nanoparticle formulation of SN-38, the active metabolite of irinotecan, and~     is intended to deliver more drug to the tumor with reduced toxicity on normal tissues. The~     study is designed to determine the maximum tolerated dose (MTD) of IT-141, and to investigate~     pharmacokinetic (PK) parameters and possible pharmacodynamics (PD) relationships. Patients~     will also be monitored for any response to therapy.~   "
35928|NCT03096327|"~     • To compare the quality of Life using AQLQ (s) questionnaire after 4 weeks of Montelukast.~   "
35929|NCT03096314|"~     This study aims to evaluate the effect of early administration of high-dose vitamin D3 in~     reducing all-cause, all-location mortality in vitamin D deficient patients at high risk for~     ARDS. Patients will be screened for vitamin D deficiency (<20 ng/mL). Only patients screened~     as vitamin D deficient will be randomized. Half of the vitamin-D deficient patients will be~     given a high-dose of vitamin D3 and the other half will be given a placebo.~   "
35930|NCT03096301|"~     The general purpose of this project is to evaluate the cost-effectiveness of LIL treatment~     and occlusal plates in the treatment of pain in patients between 15 and 25 years of age with~     TMD.~   "
35991|NCT03095508|"~     The purpose of this study is to evaluate no less therapeutic efficacy and safety of the Angal~     S, topical spray [Menthol], 0,5 mg + 2 mg (Sandoz dd, Slovenia) compared to ANTI-ANGIN®~     FORMULA, topical metered spray, 0,12 mg + 0,24 mg (LLC Valeant, Russia) in treatment of~     patients with uncomplicated acute infectious and inflammatory diseases of the pharynx,~     accompanied by a sore throat.~   "
35931|NCT03096288|"~     Clopidogrel is the most widely used P2Y12 receptor inhibitor and is the only agent of this~     class currently recommended in patients with stable coronary artery disease (CAD) undergoing~     PCI, and for the treatment of stroke or PAD. Pharmacodynamic (PD) studies have shown that~     approximately 30-40% of patients experience high on-treatment platelet reactivity (HPR) while~     receiving clopidogrel treatment. Importantly HPR status has been strongly associated with an~     increased risk of ischemic events. Multiple approaches have been advocated to reduce HPR~     rates. In a previous study treatment with high-dose atorvastatin in addition to double-dose~     clopidogrel reduced platelet reactivity significantly more than double-dose clopidogrel alone~     in statin-naïve patients with stable CAD and HPR. To date, the exact biological mechanisms~     involved in the statin modulation of platelet function are not fully understood, although~     likely attributed to both its lipid-lowering and non-lipid-related effects.~      Evolocumab is a monoclonal antibody targeting proprotein convertase subtilisin/kexin type 9~     (PCSK9). The use of evolocumab plus standard therapy, as compared with standard therapy~     alone, significantly reduced the incidence of cardiovascular events. Whether the reduction in~     cardiovascular events is simply due to LDL reduction or might be related to other mechanisms~     is currently subject of investigation. Although LDL reduction with statin therapies has been~     associated with reduction in platelet reactivity, to date the effects on platelet aggregation~     of adjunctive lipid lowering with evolocumab has not been explored.~      The aim of the present study is to investigate the effects of evolocumab in addition to~     statin therapy on HPR rates and platelet reactivity in patients with atherosclerotic~     cardiovascular disease (ASCVD) and HPR while on clopidogrel treatment.~   "
35932|NCT03096275|"~     Takayasu's arteritis(TAK) is a rare systemic vasculitis which can cause ischemia or~     inflammation of the involved organs and increase the overall mortality rate.The traditional~     treatment of TAK is primarily empirical. The most commonly used drugs for treating active TAK~     are glucocorticosteroids(GC) and immunosuppressants. However, the genital toxicity of CYC has~     limited its long term use. In a pilot study carried out by the principal investigator of this~     study has shown that mycophenolate mofetil(MMF) combined with MTX is effective and with few~     adverse effects. The purpose of this prospective open-label study is to compare the efficacy~     and safety of GC+MMF+MTX with GC+CYC followed by GC+AZA for the treatment of active TAK. 150~     patients with active TAK will be recruited and randomized in a 2:1 ratio to GC+MMF+MTX group~     and C+CYC and AZA group. Patients were followed for 52 weeks for efficacy and safety~     assessment.~   "
35933|NCT03096262|"~     The purpose of this study is to advance upper limb RMTR for patients recovering from stroke~     by empowering them through active science participation. By varying the tasks' features and~     affordances of a platform that combines a low-cost haptic device on one hand, and an online~     citizen science platform on the other, investigators will evaluate different strategies for~     social telerehabilitation. the two fundamental modes of social interaction — competition and~     cooperation — in addition to a control condition. Specifically, citizen science activities~     will be performed by competing, cooperating, or isolated users, and their rehabilitation~     effectiveness examined. Such effectiveness will be measured by (i) participants'~     rehabilitation performance (inferred from sensorimotor data acquired through the platform and~     directly quantified by a supervising therapist); (ii) participants' motivations to contribute~     (measured through surveys administered online); and (iii) participants' emotional well-being~     and sense of self-esteem (measured through online surveys).~   "
35934|NCT03096249|"~     Oxytocin (OT) is a neuropeptide that acts as a neurotransmitter and neuromodulator in the~     brain. Previous studies have shown that intranasal administration of OT improves social~     cognition and behavior (e.g. emotion recognition). In the current study, we want to gain more~     insight into the underlying mechanisms by which OT influences emotion recognition. More~     specifically, we will investigate whether intranasal administration of OT enhances the~     salience of social (compared to non-social) information and whether it increases the neural~     sensitivity for subtle socio-emotional cues, by recording scalp electroencephalography (EEG)~     during Fast Periodic Visual Stimulation (FPVS).~   "
35935|NCT03096236|"~     Subepithelial gastric tumors are rare and usually detected incidentally. Most subepithelial~     tumors (SET) are benign but up to 13% of all lesions can be malignant. Histology after needle~     biopsy often brings no clear diagnosis in SET, so further strategy often remains unclear.~     Surveillance endoscopy can be associated with the risk of progression. Endoscopic resection~     usually is difficult, associated with high risk of complications and sometimes is not~     feasible. Surgical resection is also associated with a risk of complications and often~     refused by the patients. With the developement of the gFTRD-System gastric SET can now be~     resected endoscopically. The advantage of this technique is the complete resection and a~     full-thickness resections specimen for are definite histology.~   "
35936|NCT03096223|"~     The objective of this study is to evaluate the safety and tolerability of multiple~     intravenous (IV) infusions of KHK4083 in subjects with moderate or severe atopic dermatitis.~   "
35937|NCT03096210|"~     This study evaluates the radiographic, histological and clinical comparisons of the~     completely autologous T-PRF or allograft effectiveness at the maxillary sinus elevation~     procedure.~   "
35938|NCT03096197|"~     The overall aim of this project is to assess the effect of combining transcutaneous~     lumbosacral stimulation (TLS) during Exoskeleton Assisted Walking (EAW) compared to EAW alone~     without stimulation on walking recovery.~   "
35939|NCT03096184|"~     This is a non-randomized, phase II, open label study of apatinib mesylate tablets plus~     tegafur gimeracil oteracil potassium capsules in recurrent/metastatic squamous cell carcinoma~     of head and neck. The primary purpose of this study is to evaluate the efficacy of apatinib~     mesylate tablets plus tegafur gimeracil oteracil potassium capsules in recurrent/metastatic~     squamous cell carcinoma of head and neck~   "
35940|NCT03096171|"~     This protocol proposes a well-being program, delivered through an application for mobile~     devices, based on meditation and positive psychology principles such as human development,~     the improvement of virtues, quality of life and well-being. The investigators hypothesize~     that this program offered in mobile application may promote well-being and reduce stress~     related problems in the participants. Objectives: To evaluate the effectiveness of a~     well-being program delivered through an application for mobile devices in a sample of high~     school students. Methods: Sixty high school students will be recruited. The participants will~     be randomized in two groups of 30 participants each one, half of them in the control group~     (GC) and the other half to the intervention group (GI).~   "
35960|NCT03095911|"~     The main objective of this study is to compare the interpretation of health news items~     reporting results of randomized controlled trials (RCTs) with or without spin (i.e.,~     distortion of research results). The news items which reported those studies evaluating the~     treatment effect, having highest number of spin in the headline and text and received high~     online public attention will be selected. Spin will be deleted and will rewrite the news~     items without spin. This sample of news items reporting results of RCTs with and without spin~     will be interpreted by English-speaking population.~   "
35941|NCT03096158|"~     Background: Coronary artery bypass grafting (CABG) due to coronary artery disease (CAD) is~     one of the main surgical procedures performed in the area of cardiology. Individuals~     undergoing CABG present sarcopenia, decreased muscle strength of the lower limbs, decreased~     respiratory muscle strength and dyspnea due to immobility in the bed and the inherent~     conditions of the disease itself. Cardiorespiratory rehabilitation techniques are rarely used~     with measurement in hospitals and can greatly favor an early and effective reestablishment to~     this population in several parameters. Objective: To evaluate the effect of functional~     electrical stimulation (FES), ventilatory muscle training (TREMVEN), early aerobic training~     (AERO) and isometric handgrip training (ISO) on the functional capacity, endothelial function~     and cardiac parameters of individuals undergoing CABG. Methods: In a randomized clinical~     trial, volunteers will be allocated into four groups: EEF, TREMVEN, AERO or ISO in the~     preoperative period of CABG. After 48 hours (postoperative midway) of the surgery, the~     protocol will begin until after hospital discharge. The endpoints evaluated will be:~     functional capacity, respiratory muscle strength, systolic and diastolic function, arterial~     endothelial function, inflammatory profile and plasma levels of vascular endothelial growth~     factor (VEGF). Scientific contributions: Phase 1 cardiorespiratory rehabilitation with~     alternative interventions may provide an increase in functional capacity, strengthening of~     respiratory muscles, improvement in cardiac and endothelial functions, as well as increased~     systemic VEGF levels (myocardial revascularization) and improvement of the inflammatory~     profile, effectively forwarding the individuals to the rehabilitation phase 2.~   "
35942|NCT03096145|"~     This pilot study is being done to adapt an effective 1 session phone coaching intervention~     for nonsmoking support persons to a low income population. This study will also pilot new~     intervention components including text messaging and health incentives. The goal of the~     intervention is for support persons to prompt their smoker to use quitline services. To see~     if these methods are effective, smokers in this study will be asked to complete assessments~     about their quit attempts and smoking status. The study will also evaluate if the smokers use~     quitline services or not. The preliminary findings will be used to provide data for an R01~     NIH grant submission.~   "
35943|NCT03096132|"~     The objective of the study is to evaluate whether a less intensive intervention, Guided~     Self-Help Family Based Treatment (gshFBT), is non-inferior to the more intensive Family Based~     Treatment (FBT) for childhood obesity on child weight loss over 18-months. Cost-effectiveness~     of both treatments will also be compared.~   "
35944|NCT03096119|"~     Blood pressure variability (BPV) is being increasingly recognized as an important influence~     on hypertension outcomes as well as a risk factor for other cardiovascular (CV) events.~     However, in Asia there is a current lack of awareness of BPV and its significance on patient~     outcomes. Furthermore, there is ongoing debate on the role of home blood pressure (HBP)~     monitoring in managing hypertension patients and uncertainty on how best to integrate it into~     clinical practice.~      Therefore, we conduct Asia BP@Home study to assess HBP control status in each Asian country~     and develop an Asian consensus and Asia-specific treatment for hypertension.~   "
35945|NCT03096106|"~     Airway pressure-time (P-t) curve and stress index (SI) assessment have been proposed to guide~     the mechanical ventilation settings and minimize ventilator-induced lung injury.~   "
35946|NCT03096093|"~     This study evaluates four different doses of ACIT-1 for safety and for the ability to raise~     effective anti-cancer immune responses in patients with pancreatic and other late stage~     cancers. Approximately half of the patients will have pancreatic cancer and the other half~     will have other late stage cancers.~   "
35947|NCT03096080|"~     This study evaluates safety and tolerability of a single ascending dose of a tesevatinib~     liquid formulation administered to pediatric subjects with ARPKD.~   "
35948|NCT03096067|"~     The purpose of this project is to investigate if the magnitude of a loading based 12 weeks~     rehabilitation regime for patellar tendinopathy influence the clinical outcome, tendon~     structure and function.~      The investigators hypothesize that a greater magnitude (90% of 1RM) of loading will yield a~     more positive clinical outcome, tendon structure and function in patients with patellar~     tendinopathy compared to a lower magnitude of loading (55% of 1 RM) when total exercise~     volume is equal in both groups.~   "
35949|NCT03096054|"~     This clinical study is looking at a drug called LY3143921 hydrate (a Cdc7 inhibitor) in adult~     patients with advanced solid tumours. The main aims are to find out the maximum dose of~     LY3143921 hydrate that can be given safely to patients, more about the potential side effects~     and how they can be treated~   "
35950|NCT03096041|"~     Auriculotherapy is a complementary medicine, with few side effects, without contraindication,~     inexpensive and not very restrictive.Its efficacy has been found in several tests especially~     for the treatment of intraoperative pain. It remains more controversial in other indications.~     Evaluation of the value of auriculotherapy is often difficult because of the methodological~     limitations of the trials conducted. In the daily practice, the auriculotherapy is proposed~     to improve the articular pains of patients treated by AA. This Phase III study aims at~     validate this approach.~   "
35961|NCT03095898|"~     The objective of this study is to compare the effectiveness of acupuncture versus Sham~     acupuncture in reducing patient's discomfort and pain during colonoscopy with a standard~     sedation protocol. This will be objectively measured by the reduction in the amount of~     analgesia used as well as the time spent in the recovery room.~   "
35962|NCT03095885|"~     Identify individuals with greater absorption of oxalate based on increase in urinary oxalate~     excretion in response to a controlled oxalate-rich test meal.~   "
35978|NCT03095677|"~     The inclusion of short periods of apnea (several seconds) during exercise (i.e. dynamic~     apnea) induces a significant decrease in blood oxygenation and muscle tissue. To date, the~     immediate effects (acute apnea) of this decrease in the quantity of oxygen available at the~     muscle and brain level are poorly understood. Moreover, a physical training during which~     these short periods of apnea (chronic apnea) would be included could lead to physiological~     adaptations and to improvement in physical performance similar to those obtained during~     altitude training.~      The purpose of this study is to evaluate the effects of acute dynamic apnea on metabolism.~   "
35979|NCT03095664|"~     The objective of the present study is to implement and evaluate the effect of a counseling~     program to promote healthy eating and practice of physical activity in the nutritional~     status, quality of life and prognosis of women Type I (endometrioid) endometrial cancer.~   "
35951|NCT03096028|"~     Common mental disorders (CMD) such as Depression, contributes significantly to the global~     burden of disease. Fetal exposure to adverse intrauterine environment mediated by life course~     factors can enhance risk of non-communicable disease in later life. Maternal micronutrients~     such as Vitamin B12 and folate play an important role in early fetal development through~     their effect on one carbon metabolism.~      Vitamin B12 deficiency is common in Indian women; however guidelines recommend only iron,~     folic acid supplementation during pregnancy. This study aims to investigate effects of~     maternal B12, folate during pregnancy on mental health and neurocognitive outcomes in~     offspring during adulthood.~      The Pune Maternal Nutrition Study(PMNS) birth-cohort(n=762) was established in 1993 at the~     Diabetes Unit of KEM Hospital Pune with well characterized serial data and archived~     biological samples. The subjects of the cohort are now in age range of 20-22 years and this~     provides an opportunity to examine the proposed objectives.~      Key objectives:~      To examine the specific association between maternal vitaminB12, folate, homocysteine levels~     at 18 & 28 weeks of gestation and risk for CMD, neurocognitive outcomes.~      Examine the causality of this association by Mendelian randomisation using genetic~     determinants of vitamin B12 and homocysteine.~      Design and analysis:~      Consenting members of the birth cohort of PMNS (n=690) will be recruited after ethics~     approval.~      Following cross-sectional outcome measures will be measured Neurocognitive functions: using~     standardized neuropsychological battery Brain imaging for Structural and functional magnetic~     resonance imaging (MRI). Temperament-character dimensions (TCI):140 item short TCI-R.~     Structured clinical interview for CMD, Diet, physical activity, High-risk behaviors, Early~     life stress.~      Serum Brain Derived Neurotrophic factor (BDNF), Insulin like growth factor (IGF-1) from serum~     archived at 6,12 & 18 years.~      Longitudinal methods and multivariate regression analysis would be used to investigate the~     hypothesized associations. Path analysis will be used to generate pathways of evolution of~     the abnormalities.~      Causality of the associations will be assessed by Mendelian randomization analysis~     (triangulation and instrumental variable analysis) using maternal genetic determinants of~     vitamin B12 and homocysteine~   "
35952|NCT03096015|"~     An intensive, interdisciplinary treatment program was administered during the summer as part~     of regular clinic services in the Aphasia Resource Center (ARC) at Sargent College. This~     program was run program as described for three years. Not more than six native English~     speakers with mild or moderate profiles of aphasia and multidisciplinary rehabilitation needs~     (OT,PT, SLP and nutrition) were recruited from the Boston community to participate in an~     intensive interdisciplinary treatment program for four weeks during the month of June 2013.~     The program consists of approximately six hours of interdisciplinary treatment each day, five~     days per week over a four-week interval. Treatment is individualized using current~     evidence-based treatment approaches, which are commonly accepted protocols in clinical~     practice and will be administered by clinical faculty and staff from Speech-Language and~     Hearing Sciences, Occupational Therapy (OT), Physical Therapy (PT), the Center for~     Neurorehabilitation and Nutrition. Segments of these types of treatments are available for a~     small fee as part of our service in the Aphasia Resource Center; however, this comprehensive,~     interdisciplinary program is not available of this research study.~      Approximately 30 hours of therapy per week are provided -- 6 hours per day over 5 days~     consisting of Speech-language Pathology, Physical Therapy, Occupational Therapy, and~     Nutrition Counseling.~   "
35953|NCT03096002|"~     The purpose of this study is to address whether inactive individuals with prediabetes who~     take part in the Small Steps for Big Changes program, which is a 3-week supervised exercise~     and lifestyle change program with brief counseling, will be more adherent to regular exercise~     one year after program completion compared to before they took part in the program.~   "
35954|NCT03095989|"~     The psychological impact of ALS on both patients and caregivers is high and affects their~     quality of life (QOL). However, there is minimal research about psychological interventions~     to improve QOL in the ALS scientific literature.~      Recent advances in clinical treatments aimed at improving the health of people with chronic~     disorders are based on the concept of mindfulness. Mindfulness can be defined as a flexible~     state of mind resulting from the simple act of actively noticing new things, as opposed to~     mindlessness, the human tendency to operate on autopilot.~      Preliminary data suggests that mindfulness may promote a better QOL for people with ALS and~     their caregivers. The investigators also found that a mindful attitude was associated with~     slower disease progression.~      This project's goal is to develop an innovative, web-based online mindfulness training~     program and intervention, customized for people with ALS and their primary caregivers. It is~     an active learning intervention, with cognitive exercises and lectures that increase~     participants' mindfulness. The efficacy of this program for improving QOL, and for reducing~     anxiety and depression in people with ALS and their caregivers, will be tested with a~     randomized clinical trial. Assessments immediately post-treatment as well as 3 and 6 months~     after recruitment will be conducted, comparing subjects undergoing the mindfulness~     intervention to a control group.~   "
35955|NCT03095976|"~     The purpose of this pilot project is to evaluate the efficacy of application of~     Amnion-Chorion allograft membrane on the root surface of periodontally diseased teeth in~     conjunction with bone substitute covered by Amnion-Chorion allograft in a combination GTR~     treatment of periodontal intrabony and furcation defects.~   "
35956|NCT03095963|"~     A prospective, randomized, single-blind, controlled, investigator-started clinical trial was~     carried out. Patients with primary hypothyroidism were randomly assigned to the study~     (VSL#3®+ LT4) and the control group (LT4). A two months treatment phase was followed by two~     months of follow-up. Clinical examination, blood tests for thyroid function and for~     peripheral tissue markers of thyroid hormones effect were performed monthly for 4 months. LT4~     dose adjustments were performed during the study when necessary.~   "
35957|NCT03095950|"~     The main objective of this study is to compare the interpretation of health news items~     reporting results of randomized controlled trials (RCTs) with or without spin (i.e.,~     distortion of research results). The news items which reported those studies evaluating the~     treatment effect, having highest number of spin in the headline and text and received high~     online public attention will be selected. Spin will be deleted and will rewrite the news~     items without spin. This sample of news items reporting results of RCTs with and without spin~     will be interpreted by French-speaking population.~   "
35958|NCT03095937|"~     The goal of this study is to evaluate fetal myocardial performance in patients with heart~     diseases in comparison to normal pregnant patients.~   "
35959|NCT03095924|"~     The main objective of this study is to compare the interpretation of health news items~     reporting results of randomized controlled trials (RCTs) with or without spin (i.e.,~     distortion of research results). The news items which reported those studies evaluating the~     treatment effect, having highest number of spin in the headline and text and received high~     online public attention will be selected. Spin will be deleted and will rewrite the news~     items without spin. This sample of news items reporting results of RCTs with and without spin~     will be interpreted by French-speaking patients.~   "
35963|NCT03095872|"~     In the field of dermatology the healing process and therefore the success of a laser~     treatment are strongly determined by an appropriate postoperative treatment of the~     laser-treated skin. The manufacturer of CO2 laser systems recommends the application of~     Vaseline postoperatively to protect the treated tissue from air exposition until encrustation~     of the laser-treated skin decreases (usually after 7-14 days). An alternative to Vaseline~     could be Bepanthen® Wund- und Heilsalbe (Bayer). It contains the active ingredient~     pro-vitamin Dexapanthenol, which is widely used in dermatology therapy. The product helps to~     stabilize the protective barrier of the skin, to reduce the skin irritation, to stimulate the~     skin regeneration and to promote the wound healing. In an in-vitro study Bepanthen® Wund-~     und Heilsalbe triggered wound closure significantly faster compared to Vaseline. In this~     study the effect of Bepanthen® Wund- und Heilsalbe on wound healing should be investigated~     and compared to Vaseline in vivo following fractional ablative CO2 laser treatment of~     photo-damaged skin.~   "
35964|NCT03095859|"~     This randomized, feasibility trial (n=40) will compare the effects of an intensive, twice~     daily inpatient physical rehabilitation program against standard care (once daily) following~     double lung transplantation.~   "
35965|NCT03095846|"~     This study investigates cold-induced brown fat activation in winter swimmers and not-winter~     swimmers by skin temperature measures assessed with infra red thermography imaging and skin~     temperatures. Winter swimmers and not-winter swimmers will participate in an acute cooling~     intervention and thermoneutral intervention for comparison of energy expenditure and skin~     temperatures at the supraclavicular area.~   "
35966|NCT03095833|"~     Functional Magnetic resonance study on the effect of cognitive context variables on the~     perception and valuation of food odorants and flavor. The study is composed of two~     experiments; in a first experiment we address the question of how valuation of food odors are~     modulated by 3 cognitive conditions (indulgence, healthy, and neutral). Food odors are~     delivered using a custom-made olfactometer. Here we hypothesize that cognitive regulation can~     modulate the primary sensory processing of food odors. We expect that cortical regions~     related with valuation and cognitive regulation such as the ventromedial prefrontal cortex~     and the dorsolateral prefrontal cortex operate the modulation of primary olfactory cortex and~     amygdala. In a second experiment, we aim to reveal the brain areas involved in integrating~     food color cues with odor and taste stimuli. Here we hypothesize that color cues are capable~     of biasing flavor attributes of food (flavor intensity), and that this bias occurs at~     different cortical areas commonly associate with multisensory integration such as the~     orbitofrontal cortex, insula, amygdala and hippocampus.~   "
35967|NCT03095820|"~     To compare the effectiveness of usual care management (UCM) for geriatric depressive symptoms~     in the community vs newly-developed lifestyle modification with contingency management (LMCM)~   "
35968|NCT03095807|"~     This trial is conducted in the United States of America (USA). The aim of this trial is to~     assess the safety and tolerability of single doses of NNC9204-1706 administered~     subcutaneously in male subjects being overweight or with obesity.~   "
35969|NCT03095794|"~     The purpose of this study is to investigate neural mechanism of healthy humans underlying~     group decision making and compare it with that of individual decision-making. Using~     functional neuroimaging technology combining with computational modeling, we examine how the~     human brain process social information to make a decision within a group, which often guides~     humans to make a better decision using collective wisdom.~   "
35970|NCT03095781|"~     This phase Ib trial studies the side effects and best dose of Hsp90 inhibitor XL888 when~     given together with pembrolizumab in treating patients with advanced gastrointestinal cancer~     that has spread to other places in the body. XL888 may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as~     pembrolizumab, may block tumor growth in different ways by targeting certain cells. Giving~     XL888 with pembrolizumab may work better in treating patients with gastrointestinal cancer.~   "
35971|NCT03095768|"~     The Center for Lifestyle Medicine at the Cleveland Clinic Wellness Institute has a proven~     track record of engaging patients in healthy living and eating through education, live~     cooking demonstrations / hands-on cooking classes, exercise and stress management programs.~      As a result of the Community Health Needs Assessment, we are collaborating with Cleveland~     Clinic Community Outreach and 12th District Representative, John E. Barnes, Jr., to extend~     our expertise to the community of Warrensville Heights, Ohio.~   "
35972|NCT03095755|"~     The investigators will test whether an intervention called ischemic conditioning can improve~     paretic leg motor function in chronic stroke subjects.~   "
35973|NCT03095742|"~     In comatose patients resuscitated from out of hospital cardiac arrest (OHCA), neurological~     injuries remain the leading cause of death. The in-hospital mortality is reported at 30-50%,~     and the total mortality, although improved substantially over the last decade, remain to be~     significant, in most countries at up to 90%. An adequate blood pressure must be maintained in~     the post-cardiac arrest patient and helps to avoid further brain injury. The current trial~     addresses strategies for neuroprotection using a design of two different target blood~     pressure levels. Normal MAP (approximately 65 mmHg) vs. high MAP (approximately 75 mmHg).~     Markers measuring global cerebral ischemia caused by cardiac arrest and consecutive~     resuscitation, and reflecting the metabolic changes after successful resuscitation are~     urgently needed to enable a more personalized resuscitation and post resuscitation care.~      It is technically simple and feasible to place a microdialysis catheter in the jugular bulb~     and monitor biochemical variables related to cerebral energy metabolism bedside. The LP ratio~     obtained from microdialysis of cerebral venous blood may be a sensitive indicator of~     impending cerebral damage and might play a critical role in detecting the early responses of~     post resuscitation care. Aim of this study is to investigate the global cerebral metabolic~     changes during CA and post-resuscitation care.~   "
35974|NCT03095729|"~     The purpose of the study is to measure the negative cognitive consequences of the ventilation~     under pathological or experimental cortical drive to breath.~   "
35975|NCT03095716|"~     The primary purpose is to evaluate the quality of post-operative recovery and post-operative~     pain in elderly patients (more than 75 years) who undergo laparoscopic surgery for uterine~     prolapse.~   "
35976|NCT03095703|"~     The aim of the study is to investigate the effect of sirolimus on the progression of~     intestinal adenomas in patients with FAP and to assess the safety of this treatment.~   "
35980|NCT03095651|"~     This is a randomized, active- and placebo-controlled, double-blind trial of MK-5160 in~     participants with Type 1 diabetes mellitus (T1DM) and Type 2 diabetes mellitus (T2DM). This~     is a two-part trial, with three panels per part. T1DM (Part 1) and T2DM (Part 2) participants~     will be given daily fixed doses of MK-5160 in three predefined, increasing doses in each~     panel, or glargine (active comparator). The primary hypothesis of the trial is that at a dose~     with sufficient safety, the mean steady-state maximum level of glucose infusion rate (GIRmax)~     after MK-5160 administration in both T1DM and T2DM participants is between 1.5 and 4.5~     mg/kg/min.~   "
35981|NCT03095638|"~     The aim of this cross-over study is to compare the relative bioavailability and~     pharmacokinetic parameters of both 10 mg conventional tablets and 5 mg dispersible tablets of~     dolutegravir (DTG) with that of 25 mg or 50 mg conventional DTG tablets. The study will be~     carried out in 2 parts. Part 1 of the study will be open-label, 2 period designs with a wash~     out period of at least 7 days between the dosing periods. Subjects will be randomized to~     receive either single dose of five 10 mg DTG tablets or one 50 mg DTG tablet in a crossover~     manner in the fasting state. Part 2 of the study will be a 3 period crossover design with a~     wash out period of at least 7 days between the dosing periods. Subjects will be randomized to~     receive either single dose of five 5 mg DTG tablets (administered as dispersed with water or~     directly to mouth) or one 25 mg DTG tablet in a crossover manner in the fasting state.~     Subjects will have a follow-up visit 7-10 days post last dose of study treatment.~     Approximately 14 healthy subjects will participate in Part 1 and approximately 24 healthy~     subjects will participate in Part 2 of the study. The total duration of Part 1 will be~     approximately 7 to 8 weeks and that of part 2 will be approximately 8 to 9 weeks.~      TIVICAY® is a trademark of the GlaxoSmithKline group of companies.~   "
35982|NCT03095625|"~     Coagulation dysfunction is frequent in septic patients and it is associated with an increase~     risk of mortality. During sepsis platelets number usually decreases and their function is~     reduced and this mechanism is sustained by an inflammatory induced coagulopathy. Some recent~     studies evaluated the possibility to use viscoelastic whole blood tests of the haemostasis,~     such as thromboelastography (TEG), which analyze all blood components and their interactions~     during clot formation and dissolution and might be useful for assessing bleeding risk in~     septic patients. Maximun amplitude (MA) is one of the variables obtained from TEG analysis~     and it expresses the strength of the clot and the efficacy of platelet function. A low level~     of MA describes a lower strength of the clot determined by a lower number or a reduced~     function of platelet.~      The aim of the present study is to evaluate whether a lower level of MA and a pattern of~     hypocoagulability might be associated with an increased risk of bleeding and need of~     transfusion in patients with sepsis.~      We want to conduct a prospective multicenter observational study, enrolling 100 consecutive~     adults patients with sepsis. We will exclude patients under 18 years old of age, chronic use~     of oral anticoagulant and anti platelet treatment, hematologic malignancy, congenital~     bleeding disorders, oral contraceptives, lack of consent.~      Primary end point To evaluate whether a lower level of MA might be associated with an~     increased risk of bleeding.~      Secondary end points: to evaluate whether a different level of MA correlates with the~     biomarker of the severity of sepsis such as presepsin, with the biomarker of the severity of~     infection and whether a pattern of hypocoagulability might be associated with a risk of~     mortality.~      All enrolled patients will undergo a blood sample at admission (T0), after 72 hours (T1) and~     after 7 days (T2) and all the following parameters will be measured:~      Platelet count, APTT, PT, INR, fibrinogen, procalcitonin and presepsin .~      Additionally, all viscoelastic parameters (reaction time (R), clot formation speed (K), angle~     (alpha) and maximum amplitude (MA)) will be performed at bedside, at T0, T1, T2:~      Outcome measurements: Intensive Care Unit Length of Stay and mortality at 28 days and at 90~     days.~   "
35983|NCT03095612|"~     This study is being done to evaluate the safety of the investigational study drug, selinexor~     when given with docetaxel to patients who have been previously treated for advanced KRAS~     mutant lung cancer.~   "
35984|NCT03095599|"~     This is a phase 2/3, double-blind, placebo-controlled trial of 888 adults, ages 18 to 60~     years old randomized to receive vaccine or placebo in a 5:1 vaccine:placebo randomization.~   "
35985|NCT03095586|"~     The main objective of this study is to compare the interpretation of health news items~     reporting results of randomized controlled trials (RCTs) with or without spin (i.e.,~     distortion of research results). The news items which reported those studies evaluating the~     treatment effect, having highest number of spin in the headline and text and received high~     online public attention will be selected. Spin will be deleted and will rewrite the news~     items without spin. This sample of news items reporting results of RCTs with and without spin~     will be interpreted by English-speaking patients.~   "
35986|NCT03095573|"~     Video capsule endoscopy (VCE) is recommended as the gold standard in small bowel exploration.~     The efficiency of the axial-viewing (Given, Imaging) has been widely reported. The CapsoCam~     capsule (Capsovision, California, USA) has four cameras allowing the exploration of the small~     bowel through 360 degree lateral viewing. Celiac disease is the most common autoimmune~     enteropathy in Western countries, and is usually associated with a good response to the~     gluten free diet and an excellent prognosis. However, a minority of patients develop~     complications of the disease, such as refractory celiac disease, ulcerative jejunoileitis and~     neoplastic complications such as adenocarcinoma of the small bowel and enteropathy associated~     T cell lymphoma. In recent years, the detection of small bowel lesions has dramatically~     improved thank to the availability of capsule endoscopy exploration. The aim of this study~     was to evaluate detection rate and diagnostic concordance of the axial view capsule and~     CapsoCam capsules in the same patients.~   "
35987|NCT03095560|"~     Purpose of the article: aim of the present study was to detect the differences between the~     presence or not of body shadows during a virtual reality (VR) training with BTS NIRVANA~     (BTsN). Materials and methods: In this pilot study, we enrolled 20 post-stroke rehabilitation~     inpatients, who underwent a neurocognitive-rehabilitative training consisting of 24 sessions~     (three times a week for 8 weeks) of BTsN. All the patients were randomized into two groups:~     Semi-immersive virtual training with (S-IVTSgroup) or without (S-IVTgroup) body shadows.~      Each participant was evaluated before (T0), and immediately (T1) after the end of the~     training by a skilled neuropsychologist through the administration of a complete battery, and~     by a skilled neurologist to assess motor functions.~   "
35988|NCT03095547|"~     Study of interactions between F901318 and multiple doses of posaconazole and pantoprazole and~     single doses of cyclosporine A and tacrolimus in healthy subjects. Pharmacokinetic (PK)~     profiles, safety and tolerability will be assessed.~   "
35989|NCT03095534|"~     The study evaluates the feasibility of a staff-lead workout program, 3-Step Workout for Life,~     in a local senior living community. Eligible participants will complete assessments before~     and after the workout program.~   "
35990|NCT03095521|"~     The purpose of this study is to evaluate no less therapeutic efficacy and safety of the~     Angal, lozenges [Menthol], 1 mg + 5 mg (Sandoz dd, Slovenia) compared to ANTI-ANGIN® FORMULA,~     lozenges, 0,2 mg + 2 mg + 50 mg (LLC Valeant, Russia) in treatment of patients with~     uncomplicated acute infectious and inflammatory diseases of the pharynx, accompanied by a~     sore throat.~   "
35993|NCT03095482|"~     This double-blind randomized controlled clinical trial aims to test whether transcranial~     direct current stimulation (tDCS) can be used to modulate fear extinction learning during~     exposure therapy for pathological fear, including fear of spiders, snakes, tightly enclosed~     spaces, or germs / contamination. Participation takes place over three laboratory visits,~     including (1) a pre-treatment visit, (2) a treatment and post-treatment visit, and (3) a 1~     month follow-up visit. During treatment, participants will receive either 20 minutes of~     active or sham tDCS, followed by 30 minutes of in vivo exposure therapy.~   "
35994|NCT03095469|"~     Coronary heart disease has a high incidence and high death rate. Percutaneous coronary~     intervention (PCI) is an important method for the treatment of coronary heart disease (CHD).~     However, PCI may cause myocardial cell injury and myocardial infarction 4 Type(MI4a, Type 4 a~     myocardial infarction related to PCI). Dexmedetomidine(Dex) is the only anesthetic which has~     sedative and analgesic effects. Dex currently has been widely used in perioperative~     management of various surgical.This study intends to verify the effect of heart protection of~     Dex in perioperative.~   "
35995|NCT03095456|"~     This study is a randomized, double-blind, double-dummy, parallel group study to compare once~     daily nebulized Revefenacin with Spiriva once daily delivered via the HandiHaler® on lung~     function in subjects with COPD and a Low Peak Inspiratory Flow Rate.~   "
35996|NCT03095443|"~     DDM is a study designed to Test the efficacy of personalized music therapy in reducing~     delirium incidence and severity among patients admitted to the Intensive Care Unit.~   "
35997|NCT03095430|"~     The critically ill polytrauma patient is one of the most complex cases with regard to the~     optimization of the intensive care, anesthesia, as well as postoperative management. One of~     the most important steps in the complex management of such patients is the modulation of~     anesthesia and the volemic resuscitation, especially in the first hours post-trauma, and in~     the operating room admission. We start with the assumptions that the optimization of~     anesthesia should depend on each patient, being conducted in an individual manner. We also~     believe that by individualizing the anesthesia by monitoring the entropy and SPI it is~     possible to obtain an appropriate management regarding resuscitation and volume replacement.~     Furthermore it assumes that an adequate anesthesia, and resuscitation singled volume~     replacement can reduce morbidity and mortality rates as well as the period of stay in the ICU~     and recovery time.~   "
35998|NCT03095417|"~     Primary Specific Aim: Determine the effect of the combined physical exercise and cognitive~     training on the cognitive function of ICU survivors aged 65 and older. Hypothesis: In~     comparison to older ICU survivors randomized to attention control or either intervention~     alone, those randomized to 12 weeks of combined physical exercise and cognitive training will~     have higher total index cognitive scores as assessed by the Repeatable Battery for the~     Assessment of Neuropsychological Status (RBANS) at 3 and 6 months post randomization.~      Secondary Specific Aim 1: Determine the effect of the combined physical exercise and~     cognitive training on physical performance, anxiety and depressive symptoms, and quality of~     life of ICU survivors aged 65 and older. Hypotheses: In comparison to older ICU survivors~     randomized to attention control or either intervention alone, those randomized to 12 weeks of~     combined physical exercise and cognitive training will have higher physical performance as~     measured by short physical performance battery (SPPB) and two-minute step test, lower mood~     and anxiety symptoms as measured by Patient Health Questionnaire (PHQ-9) and Generalized~     Anxiety Disorder (GAD-7) scale, and higher quality of life as measured by the Medical~     Outcomes Study 36-item short form (SF-36) at 3 and 6-months post randomization.~      Secondary Specific Aim 2: To examine the mechanisms of action of combined training.~     Hypothesis: At the completion of treatment, the combined intervention group will show reduced~     serum levels of CRP, IL-1, IL-6, IL-8, TNF-α, S-100β, and GFAP and increased levels of BDNF,~     VEGF, and IGF-1 compared to the attention control, or either intervention alone groups.~   "
35999|NCT03095404|"~     Currently, there are no studies that address the optimum dosage of lidocaine for surgical~     procedures. Lidocaine is a local anesthetic that is injected to induce anesthesia. Improper~     or inefficient pain treatment can lead to longer hospital stay, and adverse side effects such~     as nausea and vomiting. Opioids are the primary drug to treat moderate to severe pain, but~     are also responsible for nausea and other side effects. Lidocaine has shown to have opioid~     sparing effects; meaning less opioid use is necessary for pain relief. In this study, we will~     conduct a clinical trial to assess the difference between different lidocaine dosage~     schedules to determine the optimum dosage that brings maximum pain relief while minimizing~     adverse side effects and patient stay. A large benefit in using lidocaine is its documented~     opioid sparing which allows for minimal drug treatment.~   "
36000|NCT03095391|"~     This is a Phase 2b, prospective, open-label study designed to evaluate the safety,~     tolerability, PK, and PD of FAST PV and mGFR Technology in healthy subjects and patients with~     varying degrees of renal impairment.~   "
36001|NCT03095378|"~     The aim of this study was to evaluate the effect of two root-conditioning agents used in~     conjunction with subepithelial connective graft technique on root coverage outcomes. One is~     citric acid plus tetracycline and the other is antimicrobial photodynamic therapy.~   "
36002|NCT03095365|"~     to compare the effects on pain, disability and psychological factors of the combination of~     MTrP dry needling and pain neuroscience education to MTrPs dry needing alone and control~     electrotherapy usual care in patients with chronic neck pain.~   "
36011|NCT03095248|"~     In this research study the researchers want to learn more about the effects (both good and~     bad) the study drug selumetinib has on participants with neurofibromatosis type II (NF2)~     related tumor.~      The researchers are asking patients with NF2 related tumors to be in the study, because their~     hearing has decreased and/or their NF2 related tumor has started to grow.~      The goals of this study are:~        -  Determine if selumetinib will stop NF2 related tumors from growing~        -  Measure the changes in hearing after receiving selumetinib for 6 months.~        -  Determine if selumetinib improves how participants feel (physically and emotionally) and~          how participants can perform daily activities.~        -  Examine tumor tissue, if available, in a laboratory to see if NF2 related tumors have~          targets of selumetinib.~   "
36264|NCT03091933|"~     This study will evaluate the safety of infusing an anti-MiHA T cell line in patients~     suffering from an hematologic malignancy that has relapsed following hematopoietic stem cell~     transplantation from a matched donor.~   "
36003|NCT03095352|"~     This is a phase II multicenter study including breast cancer patients with chest wall disease~     that is hormone resistant (ER positive/PR positive/HER2 negative breast cancer with~     progressive disease on 2 prior lines of hormonal therapy) or triple negative (ER negative/PR~     negative/HER2 negative, TNBC). Eighty-four patients will be enrolled at Translational Breast~     Cancer Research Consortium (TBCRC) sites and will be randomized 2:1 to receive treatment with~     pembrolizumab and carboplatin (n=56, Arm A) or carboplatin alone (n=28, Arm B) until~     documented disease progression. Patients randomized to Arm B may cross-over following~     progression to pembrolizumab alone (Arm Bx). Patients may have received any number of prior~     lines of chemotherapy. Patients in Arm A will be treated with pembrolizumab 200 mg IV and~     carboplatin AUC 5 IV every 3 weeks for at least 6 cycles followed by maintenance~     pembrolizumab 200 mg IV every 3 weeks if stable or responding disease. Patients in Arm B will~     be treated with carboplatin AUC 5 IV every 3 weeks until progression, whereupon they may~     cross-over to pembrolizumab 200 mg IV every 3 weeks alone (Arm Bx). An interim analysis for~     futility will be performed after 18 patients are enrolled into Arm B to allow early stopping~     of that trial arm for lack of efficacy. The primary endpoint is to compare disease control~     rates at 18 weeks of treatment. Secondary endpoints include progression free survival,~     toxicity, and overall response rate.~   "
36004|NCT03095339|"~     This is a pre-post randomized community-based controlled trial aimed at estimating the~     effectiveness of an educational package developed using PRECEDE PROCEED to reduce the~     cumulative incidence of Taenia solium cysticercosis in three Provinces of Burkina Faso. The~     study design included an 18-months baseline study to measure baseline cumulative incidence of~     cysticercosis followed by an 18-month post randomization study to measure the effectiveness~     of the intervention. Sixty villages of three Provinces of Burkina Faso were included. The~     primary outcome was the change in the baseline to post randomization cumulative incidence in~     the intervention group compared to the control group.~   "
36005|NCT03095326|"~     Splenectomized thalassemia major subjects were provided with PCV pneumococcal vaccine~     (Prevenar 13®) at the start of the trial, following which they were randomly assigned to 2~     groups (zinc and placebo group). After 8 weeks, the subjects received PPV pneumococcal~     vaccine (Pneumovax®). Zinc syrup was provided to the zinc group at a dose of 1.5 mg/kg/day~     (maximum of 50 mg/day). Pneumococcal IgG examinations were conducted at the start of the~     trial and after 12 weeks.~   "
36006|NCT03095313|"~     This is a pilot study in which we will aim to demonstrate successful execution of the imaging~     protocol and to make observations regarding the calcification activity as measured by 18F-NaF~     PET/CT and any correlation to 1) valve age and valve type, and 2) subsequent degeneration of~     aortic valve bioprostheses based upon clinical, echocardiographic and CT parameters.~      Additionally, the data will serve as preliminary data to plan a larger study to investigate~     study objectives.~   "
36007|NCT03095300|"~     Background High-flow nasal cannula (NHF) are a promising tool for administering oxygen to~     critically ill patients with high respiratory demand.~      Prone positioning (PP) is a simple and cost-effective strategy that since 1980s has been used~     in mechanically ventilated patients with acute respiratory failure to treat oxygenation~     impairment.~      A large randomized study detected a relevant survival benefit by prone positioning in~     patients with moderate to severe acute respiratory distress syndrome (ARDS) undergoing~     invasive mechanical ventilation and managed with the ARDS network PEEP-FiO2 table strategy.~      Theoretically, PP may benefit spontaneous breathing patients too, but data concerning its~     application in such context are limited to small case series and a retrospective study.~      The investigators designed a pilot feasibility study to assess the safety and efficacy of~     prone positioning in acute hypoxemic respiratory failure patients noninvasively treated with~     NHF.~      Methods Patients: 15 adult hypoxemic (PaO2/FiO2<300 mmHg) non-hypercapnic patients with acute~     respiratory failure.~      Protocol Eligible patients will undergo NHF during a 1-hour monitoring window in the supine~     semi recumbent position (baseline, BL).~      After 1 hour of NHF in the supine semi recumbent position, an ABG and a monitoring visit will~     be performed to confirm the presence of the inclusion and the absence of exclusion criteria.~      Afterwards, each enrolled patient will be placed in the prone position for 2 hours.~      After a 2-hour PP period, the patient will be rotated and will undergo 2 hours of NHF in the~     semi recumbent supine position (Supine step).~      Measurements Patient's demographics will be collected at study entry.~      At the end of the monitoring period, and then on a hourly basis the following data will be~     collected:~        -  Respiratory rate, SpO2, pH, PaCO2, PaO2, SaO2, PaO2/FiO2;~        -  Heart Rate, arterial blood pressure;~        -  Dyspnoea, as defined by the Borg dyspnoea scale;~        -  Discomfort, as defined by a visual analogic scale (VAS) adapted to rate the procedural~          pain of ICU patients;~        -  End expiratory lung impedance (EELI), tidal volume distribution, global and regional~          lung dynamic strain (Change in lung impedence due to tidal volume/ELLI).~      The number of adverse events will be also recorded for each study step.~   "
36008|NCT03095287|"~     This is a multicenter, multinational, prospective, single-arm, nonrandomized, open-label~     study of approximately 25 male subjects with congenital hemophilia A who will receive their~     first (primary) immune tolerance induction (ITI) treatment with Alphanate.~      The study consists of 2 phases:~        -  An ITI Treatment Phase in which all eligible subjects will receive ITI treatment with~          Alphanate for a period of up to 33 months. Upon confirmation of complete immune~          tolerization, subjects will then enter a 12-month Prophylactic Phase. If, after 33~          months of ITI, a subject has achieved partial immune tolerance, the subject will enter a~          12-month Prophylactic Phase.~        -  A 12-month Prophylactic Phase for all subjects who meet the criteria for complete or~          partial success to continue on a prophylactic dosing regimen of Alphanate.~   "
36009|NCT03095274|"~     Well-differentiated gastroenteropancreatic and lung neuroendocrine tumors are generally~     malignancies with a prolonged natural history. However, clinical behavior is heterogeneous~     and when tumor progression is observed, treatment options are limited. The most used therapy~     for neuroendocrine tumors management are somatostatin analogs. However, even the use in lung~     carcinoids is quite usual, no antitumoral activity has been demonstrated. Tremelimumab and~     Durvalumab combination could be more efficient drugs to improve immune system activation and~     could obtain a significantly higher clinical benefit in these patients. Tremelimumab and~     Durvalumab would be the first immune combination agents showing efficacy in neuroendocrine~     neoplasms of different origins.~   "
36010|NCT03095261|"~     The objective of this study is to examine whether a financial incentive program increases~     minutes of moderate-to-vigorous physical activity (MVPA) per week among cardiac~     rehabilitation (CR) graduates.~   "
36019|NCT03095144|"~     Background: The purpose of this retrospective study is to evaluate surgical outcomes of~     pyloromyotomy in infants performed under spinal anesthesia compares to general anesthesia.~      Methods: After receiving the approval of the hospital ethics committee, retrieving, reviewing~     files and collecting data. Primary outcomes: total operating room time, duration of surgery,~     pain management and postoperative apnea episodes, time of regaining full enteral feeding.~     Secondary outcome measures: include cardio-respiratory changes and events, and substantial~     vomiting postoperatively.~   "
36012|NCT03095235|"~     Corneal ectasia is characterized by irregularity and thinning of the cornea, causing the~     cornea to bulge forward and cause distorted vision and impaired visual acuity. Corneal~     ectasia is a complication after refractive (LASIK) surgery. It is also the primary problem in~     keratoconus, a gradually progressive inherited condition that typically is manifested in~     young adulthood, more commonly in women. Treatment approaches to stabilize the cornea's shape~     include rigid contact lenses, surgical implantation of stiff plastic intrastromal corneal~     ring segments, a collagen cross-linking procedure and, in severe cases, cornea~     transplantation. The collagen cross-linking procedure involves topical application of a~     concentrated riboflavin (vitamin B2) solution after the corneal epithelium is scraped,~     followed by ultraviolet (UV) light exposure. UV light stimulates riboflavin to form new bonds~     (cross links) between the cornea's connective tissue, giving the cornea additional strength~     to maintain its shape and prevent the need for transplantation. The cost of one treatment~     using this system is $2,500 to $3,500. A small prospective study including 7 patients with~     keratoconus was started on a trial of oral riboflavin and 15 minutes of natural sunlight~     exposure daily. These patients reported no adverse effects and preliminary results showed~     corneal stabilization and/or corneal flattening in all 7 patients It is hypothesized that~     dietary riboflavin and natural sunlight is as effective in corneal crosslinking as the~     currently FDA approved Avedro therapy. If the clinical study confirms the investigators'~     early observations of the benefits of this approach, coupled with animal studies that~     document corneal cross-linking, the investigators will have data to pursue funding for larger~     clinical and animal studies. This has the potential to save millions of dollars in health~     care costs and ease the burden of treatment in patients who require therapy to induce corneal~     cross-linking to stabilize the cornea's shape.~   "
36013|NCT03095222|"~     The purpose of this study is to identify the optimal dosing strategy for low-dose ketamine~     infusions in adult acute burn injury patients when used with usual pain medications.~   "
36014|NCT03095209|"~     Patients on this observation study must have planned treatment regimen with concurrent CRT~     followed by planned surgery, which is considered as standard of care for their disease. The~     total radiation dose will be 50.4 Gy in daily fraction of 1.8 Gy for esophageal cancer and 60~     Gy in daily fraction of 2 Gy for non-small cell lung cancer. The concurrent chemo regimen~     will carboplatin-paclitaxel managed by the treating medical oncologist. Patients are planned~     to receive surgery at approximately 6 to 9 weeks (maximum 12 weeks post-CRT) after finishing~     CRT with surgical aspects determined by the treating surgical oncologist.~      Patients on this observation study will donate their blood samples within 4 weeks before~     initiating CRT, within 1 week before completing CRT, 1 month after CRT, and 1 month after~     surgery (or 3 months after CRT if surgery is not done for any reason). They are also~     requested to fill out questionnaires (EORTC QLQ-30, EORTC QLQ-OES18, and Pain Scale as~     attached) prior to CRT, weekly during CRT, 1 month after CRT, 1 month after surgery (or 3~     months after CRT if surgery is not done for any reason), and 6 months after CRT. Any patients~     with incomplete treatment will have samples collected up to the point where they discontinue.~     The specimen collection, handling and processing will be done by Protocol Support Lab (PSL)~     at Fox Chase Cancer Center under the directions of the Director, R. Katherine Alpaugh, PhD,~     following the procedures outlined in PSL lab manual. The patients in this observation study~     will be asked to donate a tissue specimen after the definitive surgery for investigation.~   "
36015|NCT03095196|"~     Background: Type 2 Diabetes Mellitus (T2DM) is a multi factorial disease, affecting clinical~     outcomes in failing heart (HF) patients treated by Cardiac Resynchronization Therapy with a~     defibrillator (CRT-d).~      Methods: One hundred and ninety five T2DM patients will receive a CRT-d treatment. Randomly~     the study population will receive a CRT-d via multipolar left ventricle (LV) lead pacing (n~     99 as Multipolar group), v/s a CRT-d via bipolar LV pacing (n 96, as Bipolar group). These~     patients will be followed by clinical, and instrumental assessment, and telemetric device~     control at follow up. Study design will be to evaluate, in failing heart T2DM patients,~     cardiac deaths, all cause deaths, arrhythmic events, CRT-d responders rate, hospitalizations~     for HF worsening, phrenic nerve stimulation (PNS), and LV catheter dislodgment events (and~     re-intervention for LV catheter re-positioning), comparing multipolar CRT-d v/s bipolar CRT-d~     group of patients at follow up.~   "
36016|NCT03095183|"~     Evaluation of the oropharynx is a standard component of a general medical exam for all~     pediatric patients, but is an essential exam in the undifferentiated ill child. Pediatric~     patients are unable to verbalize where they hurt, and a comprehensive evaluation is needed to~     identify the source of fever and illness. Frequently, illnesses will present atypically as~     well, and a patient complaining of abdominal pain may ultimately be diagnosed with~     streptococcus pharyngitis. If the examiner does not evaluate the posterior oropharynx, the~     throat as a cause of abdominal pain is easily overlooked. Additionally, young children are~     prone to infections with pox viruses causing herpangina, hand foot and mouth disease, oral~     thrush. Despite the importance of the posterior oropharynx exam, it can be a source of stress~     and anxiety for both the clinician and pediatric patient when a tongue depressor is used to~     evaluate the posterior oropharynx. However, there are no studies to date that have looked at~     decreasing the difficulty or at decreasing the perceived discomfort associated with the~     poster oropharynx exam in the pediatric patient when a tongue depressor is utilized. Despite~     this paucity of research, there are multiple different flavored and candied tongue depressors~     available for this purpose which may or may not aid in obtaining posterior oropharynx exam~     and decrease the discomfort experienced by the patients.~   "
36017|NCT03095170|"~     Behavioral interventions currently provide the most useful approach to addressing the~     behavioral and social needs of those with Mild Cognitive Impairment (MCI) due to Alzheimer's~     or other diseases. This randomized, multisite, 3-arm study will investigate the impact of~     computerized brain fitness vs yoga vs an active control group (wellness education) on changes~     in cognitive function, daily functioning and quality of life in persons with Mild Cognitive~     Impairment (MCI) and their partner. In addition, in vivo neuroimaging measures of plasticity~     during the pre- and post-intervention periods will be measured and compared between the three~     different treatment groups. These neuroimaging measures of plasticity will be investigated in~     their relationship to the cognitive outcomes within each group.~   "
36018|NCT03095157|"~     The aim of the study is to investigate whether pre-operative dysregulated systemic lipid~     mediator pathways are associated with increased risk for the development of persistent post~     surgical pain. In addition we will investigate whether treatment with an over the counter~     dietary supplement containing a fractionated marine lipid derivative from anchovy and sardine~     oil prevents the development of chronic pain after surgery.~   "
36031|NCT03094975|"~     Firstly, this study aims at clarifying the current situation of Emergency treatment of~     aneurysmal subarachnoid hemorrhage (SAH) in China, and analyzing the influencing factors~     contributing to transport delay, so as to improve the efficiency of emergency treatment;~     Secondly, comparison and analysis of different surgical treatment of aneurysmal SAH would be~     undertook, so as to improve the diagnosis and treatment of aneurysmal SAH.~   "
36020|NCT03095131|"~     Question: Is 12-lead electrocardiography (ECG) the most accurate and convenient diagnostic~     method for atrial fibrillation (AF)? Findings: The Heart Spectrum Blood Pressure Monitor can~     be used at home, and is capable of determining the occurrence of AF. Three measurement~     methods were used in this study. The sensitivity, specificity, PPV, and NPV of the methods~     used are between 90% and 100%, and the Heart Spectrum Blood Pressure Monitor can be~     effectively applied to AF detection.~      Meaning: The Heart Spectrum Blood Pressure Monitor can be used at home and can replace the~     need for an in-office ECG, thereby accomplishing meaningful telecare.~   "
36021|NCT03095118|"~     This study is being done to see if daratumumab is safe and effective in the treatment of~     proliferative glomerulonephritis with monoclonal immune deposits (PGNMID) and C3~     glomerulopathy associated with monoclonal gammopathy (C3GN). This is an inflammatory disease~     in the kidney due to the production of abnormal proteins. There are no known standard~     effective treatments for patients with PGNMID and C3GN secondary to monoclonal gammopathy.~     These diseases are caused by abnormal production of proteins (monoclonals) by abnormal~     clones. Daratumamb has been shown to be effective in treating patients with multiple myeloma~     a disease which also caused by over production of monoclonal proteins from abnormal clones.~     Everyone in this study will receive daratumumab.~   "
36022|NCT03095105|"~     the purpose of the study was to the compare pharmacokinetic profile of BIA 6-512 in healthy~     elderly subjects versus healthy young subjects after single and repeated oral administration~     of 200 mg BIA 6-512.~   "
36023|NCT03095092|"~     The purpose of the study was to investigate the effect of food on the pharmacokinetics of a~     single 400 mg dose of BIA 6-512 (trans-resveratrol) in healthy volunteers~   "
36024|NCT03095079|"~     The incidence of Melanoma is rapidly growthing,and in China,dacarbazine combined with~     cisplatin is conmendly used as the first-line chemotherapy of metastatic melanoma. But the~     response rate and survival results are very limited.This trial aim to add a safe and~     effective anti-angiogenesis drug,Human-recombinant endostatin,to find out a new strategy~     which may further extend the PFS and OS with a tolerated toxicity.~   "
36025|NCT03095066|"~     This is a multicenter, randomized, placebo-controlled study to evaluate AVP-786 for the~     treatment of neurobehavioral disinhibition including aggression, agitation, and irritability~     in participants with traumatic brain injury (TBI).~   "
36026|NCT03095053|"~     Introduction Embryo aneuploidy is likely the leading cause of implantation failure in IVF~     cycles. Since the inception of IVF, non-invasive morphology based scoring has mostly been~     used in the selection of embryos for transfer, resulting in relative low embryo implantation~     rates. Our understanding of the optimal conditions required for in vitro embryo culture in~     IVF has advanced significantly over the past two decades. The implementation of improved in~     vitro embryo culture technologies (i.e., culture media and incubators) has resulted in an~     increase in the number of good quality embryos and consequently in the number of blastocysts~     developing. While blastocyst transfers have seemingly improved the reproductive outcomes of~     IVF, the use of improved preimplantation genetic screening (PGS) technologies have revealed~     embryo implantation still to be sub-optimal. The main objective of this randomized controlled~     trial will be to investigate the superiority of comprehensive chromosome screening (CCS)~     euploid blastocyst transfer compared to morphology scored blastocyst transfer, in FET.~      Methods This trial will be performed as a single-centre randomized controlled trial (RCT) in~     a segmented-IVF program, with intracyoplasmic sperm injection (ICSI), blastocyst freeze-all~     and artificial frozen embryo transfer (art-FET). Normo-ovulatory infertile patients, with~     maternal age ≤35 years and at least two blastocysts with a morphology grade of 2BB~     cryopresreved, will be randomized by computer generated randomized allocation to one CCS or~     the morphology group. All transfers will be single embryo tranfers (SET) in art-FET, with~     only the first transfers following the ICSI blastocysts freeze-all included.~      Consent and Ethics Akdeniz University Medical Faculty Clinical Research Ethics Committee has~     approved the trial (reference number: 2015/399), with anonymized results to be released in~     ClinicalTrials.gov. All patients will provide informed consent, which included an agreement~     for the use of anonymised data for research.~   "
36027|NCT03095040|"~     This randomized, double blind, phase 2/3 study is aimed to evaluate the efficacy and safety~     of CM082 in combination with everolimus in Chinese patients with advanced renal cell~     carcinoma. The primary endpoint is progression-free survival.~   "
36028|NCT03095014|"~     Cesarean Myomectomy, safety and effect on uterine cavity.~   "
36029|NCT03095001|"~     Background: Malignant peritoneal adhesion is a common complication and prognostic factor of~     ovarian cancer and other primary abdominal tumors. The incidence of peritoneal adhesion in~     advanced primary peritoneal tumor is 32-56%, which has increased by more than 10 times in the~     recent decade. Malignant peritoneal adhesion is closely associated with the morbidity and~     mortality of malignant intestinal obstruction. The peritoneal adhesion may aggravates the~     abdominal symptoms and reduce quality of life. Further, the peritoneal adhesion may impede~     treatment of primary tumor, such as operation or chemotherapy, lead to a poor prognosis.~      Objective: This study aims to treat malignant peritoneal adhesion with the combination of~     antiangiogenic agent and chemotherapy, evaluate the efficacy and safety of intraperitoneal~     antiangiogenic agent plus chemotherapy. As explosive endpoints, we will examination the~     expression of VEGF-A in peritoneal cavity during the treatment.~   "
36030|NCT03094988|"~     Cognitive and functional impairment are debilitating problems for survivors of major surgery.~     Efforts to modify medical treatments to prevent such impairment are ongoing and may yet yield~     significant benefits. An area in need of study is whether building patients' cognitive and~     physical reserve through a prescribed program of cognitive and physical exercise before the~     physiological insult (a prehabilitation effort) can improve long-term outcomes.~     Prehabilitation efforts before surgery thus far have focused on preemptive physical therapy~     to improve post-surgical functional outcomes. No work, however, has been done to attenuate~     the cognitive decline commonly seen after surgical illness by exercising the brain before the~     surgical insult. Cognitive prehabilitation is a novel therapeutic approach that applies~     well-understood techniques derived from brain plasticity research. Our approach is bolstered~     by data that demonstrate that cognitive training programs are effective and have a very high~     likelihood of fostering improvement in patient outcomes across a range of populations. It is~     not yet known if these programs can improve cognitive reserve, allowing patients' minds to~     better manage the acute stress of surgery and hospitalization. The primary aim of this pilot~     study is to evaluate the feasibility of cognitive and physical prehabilitation training in~     adult patients undergoing major non-cardiac surgery who are at risk for postoperative~     cognitive and functional decline. The secondary aim is to study the effects of cognitive and~     physical prehabilitation training on cognitive abilities, functional status, and quality of~     life after surgery.~   "
36265|NCT03091920|"~     To compare the safety, tolerability, pharmacokinetic (PK) profile, and pharmacodynamic (PD)~     effects of 2 treatment regimens of IW-1973 Tablet (40 mg per day) administered orally for 2~     weeks to patients with stable type 2 diabetes mellitus and hypertension.~   "
36032|NCT03094962|"~     The proximal interphalangeal (PIP) joint is the second joint in the finger from the finger~     tip. The outcome following replacement surgery of this joint is considered unsatisfactory. In~     order to improve these outcomes, it would be helpful to understand the geometry of the joint,~     how it moves and the forces that are involved. This can be achieved using computer models~     that model the bones and the soft tissues - musculoskeletal models. In order to make these~     models as representative as possible, they should be generated using anatomical data.~      Data will initially be extracted from patients' existing magnetic resonance imaging (MRI) and~     computed tomography (CT) scans. This will enable the computer model to begin being~     constructed. In parallel to the model initialisation, anatomical and motion data of the PIP~     joint of healthy volunteers will be collected. The necessary data will be collected using CT~     and MRI scans, as well as optical motion tracking methods. These data will then be used to~     populate the musculoskeletal model.~      Once the model is constructed, it will be used to simulate the motion of the joint and look~     at the effect of a simulated PIP joint replacement. This information should then provide~     insight as to how PIP joint replacements might be improved in future.~   "
36033|NCT03094949|"~     The therapeutic effectiveness of ultrasound guided cooled-probe microwave ablation and~     laparoscopic partial nephrectomy on T1a renal cell carcinoma is compared to find a better~     approach for renal tumor.~   "
36034|NCT03094936|"~     Obesity is a worldwide health and sociopolitical problem. Excessive body-weight currently~     affects over 50% of the Brazilian population. It has been well established that obesity is an~     independent health risk. Obese individuals are at increased to extremely high risk for many~     diseases and for early death relative to those with normal weights and waist circumferences.~     The increased disease susceptibility for this subset of patients includes hypertension,~     stroke, hyperlipidemia, sleep apnea, Type 2 diabetes, neoplasms, Gastro-Esophageal Reflux~     Disease, and musculoskeletal disorders.~      Bariatric surgery is the most effective treatment for obesity. As bariatrics grow, the number~     of patients suffering from surgical-related complications also grows. One of the most~     worrisome long-term complications is weight regain, once the patient may be again affected by~     overweight-related comorbidities and face again pre-operative esthetic issues.~      This trial focus on testing efficacy and safety of two endoscopic revisional procedures in~     patients suffering from weight regain following Roux-en-Y Gastric Bypass: Ablation with Argon~     Plasma Coagulation (APC) versus APC plus Endoscopic Full-thickness Suture (with Apollo~     Overstitch device). Pouch volume, gastric emptying and gut hormones changes will also be~     assessed.~   "
36035|NCT03094923|"~     This study will evaluate the profilatic effects of inspiratory muscle training (IMT) on~     functional capacity, respiratory muscle strength, postoperative pulmonary complications and~     days of hospitalization (PPC) in patients submitted to coronary artery bypass graft surgery~     (CABG).~   "
36036|NCT03094910|"~     Patients with Raynaud's disease have an increased tendency of chest pain and migraine, and~     studies indicate that the disease might be associated with increased cardiovascular morbidity~     and mortality. Furthermore, a certain hyperactivity of the sympathetic nervous system has~     been demonstrated in these patients. Hyperactivity of the sympathetic nervous system is known~     to cause decreasing heart function, regardless of the underlying disease.~      The cardiac autonomic nervous function and thermographic parameters will be assessed in~     patients with primary and secondary Raynaud's phenomenon and glaucoma as well as in patients~     diagnosed with autonomic dysfunction such as diabetics and patients with Parkinson's disease~     in order to compare the function of the cardiac autonomic nervous system and the peripheral~     response to cold exposure. Potentially, this will lead to a better understanding of the~     cardiac autonomic nervous function in Raynaud's phenomenon. Moreover, it might give rise to a~     new perception of the condition and its association to cardiovascular disease.~      At the Department of Clinical Physiology, the current method of detecting Raynaud's~     phenomenon is time-consuming and unpleasant to the patient due to cooling for several~     minutes. Another aim of the PhD study is to implement infrared thermography as a gentler and~     possibly more sensitive method to replace the currently applied method.~      The project will also include an epidemiological study based on data obtained from the~     National Patient Registry, among others. Raynaud's phenomenon will be paired with diagnostic~     codes of conditions such as diabetes mellitus, Parkinson's disease, glaucoma, and~     cardiovascular disease.~   "
36037|NCT03094897|"~     The purpose of this study is to determine whether 18F-Al-NOTA-MATBBN is safety and effective~     for cancer diagnosis.~   "
36038|NCT03094884|"~     Phase I study with the hypothesis that Pulsed Low Dose Radiation (PLDR) radiation delivery~     technique can significantly decrease the rate of severe acute esophagitis in patients~     receiving concurrent Chemo-radiation therapy (CRT) for non-small cell lung cancer or~     esophageal cancer while maintaining similar efficacy. For these patients, the rate of severe~     acute esophagitis during concurrent CRT is high (approximately 20%) when conventional~     external beam radiation is utilized. Severe acute esophagitis can cause many adverse~     consequences such as severe discomfort, weight loss, hospitalization, interruption/early~     termination of treatment, and worse surgical complications for those who receive surgery~     after CRT. PLDR radiation has the potential to maintain the tumor control rates of~     conventional radiation while decreasing the toxicity to the surrounding normal tissue 29-35.~      We have completed accrual to a phase I PLDR radiation study, in which patient received~     palliative re-irradiation with PLDR technique for their metastatic disease in previous~     irradiated field. In that phase I study, PLDR demonstrated safety for acute toxicities in the~     setting of re-irradiation for a total dose of 50 Gy, with analysis of 60 Gy pending. The~     follow up time for that phase I study is limited as most enrolled patients have short overall~     survival due to their terminal illness.~      This proposed phase I study is, to our knowledge, the first clinical study with combination~     of PLDR radiation and concurrent chemotherapy for definitive treatment.~   "
36049|NCT03094741|"~     The primary purpose of this pilot study is to evaluate the feasibility and acceptability of a~     Mobile Digital Solution in monitoring and collecting symptom burden data. The proposed study~     is meant to be the preparatory work for an intervention study to test the effect of Mobile~     Digital Solutions on improving patient outcomes by prompting early interventions for symptom~     relief and support of patient and family caregiver quality of life (QOL).~   "
36050|NCT03094728|"~     The study aimed to assess HLA compatibility, HLA antibodies and cross matching in liver~     transplantation recipients and their relation to acute rejection, CMV infection, and~     recurrence of HCV.~   "
36039|NCT03094871|"~     Comorbid depression and multiple medical conditions in older adults are a serious public~     health problem. As an important facilitator of health-related activities, families are~     already involved in various aspects of self-management of chronic disease in older adults.~     Despite the benefits they provide, informal caregiving activities currently are organized~     outside the medical system, which potentially creates redundant or misaligned efforts.The~     purpose of the mentored research is to examine the feasibility and acceptability of the~     FACE-PC, a theory-driven, multi- component, technology-assisted interdisciplinary team-based~     care model that systematically involves family in chronic disease management. It aims to~     optimize the patient and family's collective ability to self-manage chronic disease.~   "
36040|NCT03094858|"~     Participants (N = 300) will be randomly assigned to: 1) an equipment-only comparison group~     that receives a smartphone and an activity monitor wristband but does not receive smartphone~     intervention prompts, or 2) the intervention group who will receive an activity monitor~     wristband that works in conjunction with a smartphone to reduce sedentary time via smartphone~     prompts during prolonged sedentary bouts. All participants will be provided with a Fitbit®~     wristband activity monitor and an Android smartphone on the same day of the week (i.e.,~     Mondays). Participants will complete a 1-week baseline accelerometer and EMA period prior to~     the start of the intervention. Participants will be followed for 26 weeks after the~     intervention begins with follow-up visits at 6, 13, and 26 weeks. The primary outcome will be~     accelerometer-measured time spent in sedentary activity. Sedentary breaks, total active time,~     and time spent in light, moderate, and vigorous activity will be additionally evaluated as~     outcomes. Contextual variables and potential treatment mechanisms will be assessed via~     traditional questionnaire measurement and daily random EMAs at baseline and all follow-up~     visits. Brief smartphone-based daily diary assessments will be completed daily for the~     duration of the study.~   "
36041|NCT03094845|"~     hdmASIT+TM product is based on highly purified allergen fragments from house dust mites. The~     purpose of this study is to assess the safety and clinical tolerability of subcutaneous~     immunotherapy with hdmASIT+TM in patients with house dust mite-induced allergic~     rhinoconjunctivitis compared to placebo.~   "
36042|NCT03094832|"~     This is an open label, Phase 1/2 study of oral ARQ 092 administered to patients at least 2~     years of age with overgrowth diseases and/or vascular anomalies with genetic alterations of~     the PI3K/AKT pathway.~   "
36043|NCT03094819|"~     The PROTECT2 pilot study is a single cohort prospective study to gather pilot data and~     finalize operational details of the main study.~      The PROTECT2 main study is a prospective randomized controlled multi-center three group~     clinical trial. The primary endpoint is the percentage of participants in each study group~     obtaining a qualified eye examination within 12 months of their enrollment in the study.~   "
36044|NCT03094806|"~     This study is evaluating the use of a respiratory device, the Acapella Vibratory Positive~     Expiratory Pressure (PEP) Therapy device, in patients admitted to the hospital with a chronic~     obstructive pulmonary disease (COPD) exacerbation.~   "
36045|NCT03094793|"~     Cognitive disorders are a major problem in patients with epilepsy. One hypothesis is that the~     anomalies EEGs (AIC) may be responsible for short periods of attentional fluctuations causing~     a reduction of intellectual efficiency of patients. In this project, we propose to evaluate~     the impact of AIC on cognitive performance, specifically on attentional performance (central~     parameter of cognitive functioning) through the use of a computerized cognitive test (called~     STABILO, detailed below after) to measure, with good temporal sampling, the level of~     attentional engagement of patients in relation to their EEG activity.~      The originality of this study lies in the synchronization of two examinations usually made~     independently (EEG and psychometric testing), respecting a precise temporal coupling. The aim~     is to provide clinicians with a tool to assess very quickly attentional fluctuations in~     epileptic patients, and to assess the potential impact of AIC on the occurrence of these~     changes, with possible therapeutic implications (treatment of AIC and / or specific treatment~     of attention deficit disorder).~      The main objective of this study is to assess whether the presence of AIC EEG can induce a~     weakening of attentional performance.~   "
36046|NCT03094780|"~     This study will use video technology in conjunction with in-person participation. This is a~     pilot project, where all enrolled participants will receive the multidisciplinary~     intervention. Participants (patients and caregivers) from Mayo Clinic Rochester will attend~     an in-person group session, and participants (patients and caregivers) from Mayo Clinic~     Florida or Northfield Mayo Clinic Radiation Oncology Center will participate through the use~     of video conferencing. The goals are to examine feasibility (percent of eligible patients and~     caregivers who enroll), attrition, and adherence (attend at least four of the six sessions),~     to determine any differences between the two formats, and to examine potential QOL~     differences as a result of the intervention.~   "
36047|NCT03094767|"~     Cardiovascular autonomic dysfunction reflects the pathophysiology of Diabetes Mellitus in~     this patient group favors an increase in morbidity and mortality related to cardiovascular~     events, and for this reason has been one of the most studied clinical entities.~      Therefore this work aims to analyze the cardiorespiratory parameters and glycated hemoglobin~     after the commission of a rehabilitation program in patients with diabetes mellitus type 2.~      The collection protocol is to check the heart rate, blood pressure, double product, Borg~     scale, variability heart rate and glycated hemoglobin of patients with type 2 diabetes This~     project this is an experimental study, the type randomized clinical trial on the hemodynamic~     response and glucose levels in patients with DM2 institutionalized in Acre Hospital~     Foundation submitted to one rehabilitation program consisting of aerobic and anaerobic~     exercises performed for 12 weeks in three weekly meetings, of 60 minutes each.~   "
36048|NCT03094754|"~     The primary purpose of this study is to investigate the effects of excised surface area/body~     surface area ratio and location of excision on the postoperative pain after nevi excision in~     children.~      The primary purpose of this study is to investigate the effects of excised surface area/body~     surface area ratio and location of excision on the emergence excitation after nevi excision~     in children.~   "
36060|NCT03094598|"~     The purpose of this study is to investigate the knowledge about randomised clinical trials~     and the attitude towards clinical research among Danish outpatients. The INFO Trial was~     designed as a randomised, parallel group, observer-blinded trial comparing three types of~     written information (a leaflet, a brochure, and a booklet) to each other and to a no~     intervention group.~   "
36051|NCT03094715|"~     TENSION (Efficacy and safety of ThrombEctomy iN Stroke with extended leSION and extended time~     window) is a prospective, open label, blinded endpoint (PROBE), European two-arm, randomized,~     controlled, post-market study to compare the safety and effectiveness of endovascular~     thrombectomy as compared to best medical care alone in the treatment of acute ischemic stroke~     patients with extended stroke lesions defined by an Alberta Stroke Program Early CT Score~     (ASPECTS) score of 3-5 and in an extended time window (up to 12 hours or unknown time of~     symptom onset). Up to 714 subjects will be randomized. Primary endpoint will be functional~     outcome assessed by the modified Rankin scale at 90 days post-stroke (mRS shift analysis).~     By this, TENSION will provide evidence of efficacy and safety of thrombectomy in an acute~     stroke population with uncertain benefit of endovascular stroke treatment.~   "
36052|NCT03094702|"~     The SPRINT study used a blood pressure measurement procedure that differs from earlier~     studies in arterial hypertension. SPRINT type readings are lower than regular office~     measurements. The extent of the disagreement between SPRINT and office measurements may~     differ in distinct patient groups. This difference is not yet known for patients after renal~     transplantation. However, it is important to know the difference in order to apply SPRINT~     findings to transplant recipients.~   "
36053|NCT03094689|"~     Objective: To analyze the effect of cold water immersion (CWI) on the recovery of clinical,~     biochemical, functional and neuromuscular markers of muscle damage in 10 km street runners.~      Materials and Methods: This is a randomized, blinded trial in which 30 subjects, 10 km street~     runners, were randomly divided into three groups: control (gC), immersion (gI) and CWI~     (gCWI). The runners will be evaluated for clinical (subjective perception of exertion),~     biochemical (serum CK), functional (unipodal triple hop distance and shuttle test time) and~     neuromuscular variables by means of isokinetic variables (peak torque, total work and fatigue~     index). Volunteers will perform pre-assessment, immediately post-race and post-intervention,~     and 24-hour post-intervention. The data will be expressed by mean and standard deviation,~     analyzed in the statistical package SPSS 20.0. A significance level of 5% and a 95%~     confidence interval will be considered for all measures.~   "
36054|NCT03094676|"~     Performing physical exercise alters the body's homeostasis, and recuperative techniques seek~     to anticipate and potentiate the body's recovery. One of the ways to demonstrate a recovery~     of the organism is the resumption of autonomic cardiac modulation analyzed through heart rate~     variability (HRV), a method of global assessment of the behavior of the autonomic nervous~     system. Among the recovery techniques, massage is the most widely used technique in sports.~     Therefore, the objective of the study will be to measure the effects of massage as a~     recuperative technique on autonomic cardiac modulation at different moments of application.~     It will be a randomized clinical trial where there will be five stages of evaluation. In the~     first stage, the behavior of the baseline HRV will be evaluated, in the second stage the~     behavior of the HRV in front of the massage, in the third stage the behavior of the HRV in~     front of the stress protocol, in the fourth stage the HRV behavior after the stress protocol~     and immediately after Execution of the massage and finally in the 5th stage where the HRV~     behavior will be evaluated after the stress protocol and the massage application will be~     performed at the moment of HRV recovery. The stress protocol will be composed of squats~     followed by jumps and wingate test, and massage by slides in the anterior thighs and~     posterior trunk. The HRC indexes in the time domain, frequency domain and Poincaré plot, as~     well as cardiorespiratory parameters and a questionnaire on individual touch perception will~     be analyzed. The descriptive statistical method will be used and comparisons of~     cardiorespiratory parameters and HRV indices will be performed using the analysis of variance~     technique for repeated measures model in the two factor scheme. The level of significance~     will be p <0.05 for all tests.~   "
36055|NCT03094663|"~     A comparison of two pain control methods - the combination of Adductor Canal Block~     (ACB)/Periarticular Injection (PAI)/Infiltration of the interspace between the popliteal~     artery and the capsule of the posterior knee (IPACK) versus the Periarticular Injection (PAI)~     - in patients undergoing total knee arthroplasty. Primary outcome is NRS pain scores with~     ambulation on postoperative day one (24 hours post-block administration).~   "
36056|NCT03094650|"~     The present study aims at investigating (i) the feasibility in chronic stroke of using a~     dedicated virtual reality (VR) based system that embeds real-time 3D motion capture and~     embodied visual feedback to deliver functional exercises designed for training of impaired~     upper limb motor skills, (ii) whether chronic stroke survivors improve in functional outcomes~     in the upper limb when exposed to intensive VR-based therapy, and (iii) safety and tolerance~     to such a technology. The investigators hypothesize that intensive VR-based rehabilitation~     may lead to high rehabilitation doses and functional improvement in chronic stroke.~   "
36057|NCT03094637|"~     The goal of this clinical research study is to learn if azacitidine in combination with~     pembrolizumab can help to control myelodysplastic syndrome (MDS). The safety of this drug~     combination will also be studied.~      This is an investigational study. Pembrolizumab is FDA approved and commercially available~     for the treatment of melanoma and non-small cell lung cancer. Azacitidine is FDA approved and~     commercially available for the treatment of MDS. The use of the study drugs in combination is~     investigational. The study doctor can explain how the study drugs are designed to work.~      Up to 40 participants will be enrolled in this study. All will take part at MD Anderson~     Cancer Center.~   "
36058|NCT03094624|"~     The project studies auditory deficits in congenital amusia at the behavioral and~     neurophysiological levels.~      The auditory processes investigated are pitch discrimination, short-term memory,~     sound-induced emotions. To characterize auditory deficits in the amusic population,~     neuropsychological assessments are combined with neurophysiological markers~     (Electro-encephalography: EEG, Magneto-encephalography: MEG, Magnetic Resonance Imaging:~     MRI).~   "
36059|NCT03094611|"~     Any time the words you, your, I, or me appear, it is meant to apply to the potential~     participant.~      The goal of this clinical research study is to learn if inotuzumab ozogamycin can help to~     control the disease in patients with acute lymphocytic leukemia (ALL). The safety of this~     treatment will also be studied.~      This is an investigational study. Inotuzumab ozogamycin is FDA approved and commercially~     available for the treatment of ALL.~      Up to 48 patients will take part in this study. All will be enrolled at MD Anderson.~   "
36063|NCT03094559|"~     The purpose of this study is to demonstrate the utility of the FlowMet™ device in the~     assessment of perfusion in subjects suspected of or being treated for critical limb ischemia,~     in comparison to other gold standard technologies, such as ankle brachial pulse index (ABI),~     skin perfusion pressure (SPP), toe brachial pulse index (TBI), transcutaneous oxygen tension~     (TcP02), and angiography currently in use in the clinic.~   "
36064|NCT03094546|"~     The overall objective of this study is to examine the effect of polyamine supplementation on~     cognitive performance and further characterization of individuals with subjective cognitive~     decline.~   "
36065|NCT03094533|"~     The purpose of this study was to evaluate the efficacy and safety of sevoflurane-only~     Volatile induction and maintenance anesthesia (VIMA) and total intravenous anesthesia (TIVA)~     using only propofol in adult patients scheduled for elective lobectomy surgery. We would like~     to know if there is a difference in blood glucose levels during surgery and whether the cause~     is due to the difference in secretion of insulin and cortisol. In addition, we aim to~     contribute to the improvement of the prognosis of the patients by helping the selection of~     general anesthesia more effective in maintaining homeostasis in the surgical patients by~     general anesthesia and further controlling the blood glucose level.~   "
36066|NCT03094520|"~     The main objective of the proposed research is to extend our understanding of how gesture and~     language interact, focusing on the role of cognitive embodiment in this interaction, and to~     explore the neural systems that support links between language and actions systems.~   "
36067|NCT03094507|"~     The purpose of this study is to look at the levels of three HIV medications: dolutegravir,~     darunavir and cobicistat in the blood after drug intake has been stopped, in order to~     understand how long these drugs persist in the blood. The study will specifically look at~     blood levels of these three drugs after taking them every day for 14 days.~      There will be two groups. Participants in Group 1 will take dolutegravir everyday for 14~     days, then nothing for 7 days, then dolutegravir and darunavir/cobicistat together for 14~     days, nothing for 7 days, and then darunavir/cobicistat alone for 14 days. If participants go~     into Group 2 they will begin with darunavir/cobicistat everyday for 14 days, then nothing for~     7 days, then dolutegravir and darunavir/cobicistat together for 14 days, nothing for 7 days,~     and then dolutegravir alone for 14 days. Drug levels for both groups will be measured on days~     14, 35 and 56. If the participants decide to take part, the duration of the study will be up~     to 57 days plus a screening visit which will take place up to 28 days prior to the start of~     the study, and a follow up visit, which takes place 15 to 22 days after the last dose of~     study medication. Eligible participants will be randomized (1:1 ratio) to group 1 or group 2.~     Participants and the study doctor will know which study medications the participant is taking~     at all times during the study.~   "
36068|NCT03094494|"~     An observational two-center case-control study exploring the clinical impact of~     double-carbapenem use in a population of critically il patients with severe~     carbapenem-resistant Klebsiella pneumoniae infection~   "
36069|NCT03094481|"~     The optimal analgesic peripheral nerve block (or combinations thereof) are undefined for~     clavicle fractures, the most frequent fracture in the human population. This goal of this~     study is to determine whether interscalene block (ISB), superficial cervical plexus block~     (SCPB), or both provide the best analgesia for lateral and midshaft clavicular fractures,~     respectively.~   "
36070|NCT03094468|"~     The aim of this phase III study is to establish the efficacy and safety of P-3058~     (terbinafine 10% nail solution) topically administered once weekly in patients with~     onychomycosis in comparison to the Vehicle in a double-blind fashion. The overall treatment~     period will be of 48 weeks.~   "
36071|NCT03094455|"~     A new rehabilitative approach, called AOT, based on the recent discovery of mirror neuron~     system (MNS), has been used with promising results on the Upper Limb (UL) function in some~     studies in children with Cerebral Palsy (CP).The purpose of the present trial is to provide~     evidence by a RCT that AOT is an effective rehabilitation tool in Children with Unilateral CP~     (UCP) and that its effects are greater than standard care. Assisting Hand Assessment is~     chosen as primary outcome measure and a sample size of 10 per group is required. The~     rehabilitation lasting 3 weeks will be provided at home by an ICT platform able to deliver,~     manage, monitor and measure a personalized AOT.~   "
36072|NCT03094442|"~     The primary aim is to evaluate whether standard administration of Dexamethasone at the time~     of general anesthesia induction at the time of minimally invasive sacrocolpopexy (MISC) would~     result in improved quality of recovery (QoR).~   "
36073|NCT03094429|"~     This is an adaptive, Phase II/III study in 2 parts (i.e. Part 1 (dose ranging) and Part 2~     (Hypothesis testing)). NaBen® is granted Breakthrough Therapy Designation by US FDA as~     treatment for refractory schizophrenia.~      Part 1 Objectives: There are two primary objectives for Part 1 of this study:~        1. To evaluate, in terms of dose-response, the effectiveness of NaBen® (1000 and 2000~          mg/day) compared to Placebo (0 mg/day), when combined with clozapine, in improving the~          residual symptoms associated with refractory schizophrenia in adults, and; to determine~          the optimal dose to be used in Part 2 of this study.~        2. Sample size re-assessment to evaluate the final sample size needed to proceed with Part~          2 of the study The secondary objective of the Part 1 of this study is to evaluate the~          safety and tolerability of NaBen® (1000 and 2000 mg/day) compared to Placebo (0 mg/day),~          in combination with clozapine.~      Part 2 Objectives: The primary objective of the Part 2 of this study is to evaluate the~     effectiveness of NaBen® (at the optimal dose determined in the Part 1 of this study) compared~     to Placebo (0 mg/day), when combined with clozapine, in improving the residual symptoms~     associated with refractory schizophrenia in adults. The secondary objective of the Part 2 of~     this study is to evaluate the safety and tolerability of NaBen® (at the optimal dose~     determined in the Part 1 of this study) compared to Placebo (0 mg/day), in combination with~     clozapine.~   "
36074|NCT03094416|"~     This is an open-label therapeutic efficacy study of Tirosint (levothyroxine sodium) capsules~     in thyroidectomized patients taking proton pump inhibitors and levothyroxine, evaluating~     changes in serum levels of TSH upon switch to Tirosint with respect to baseline.~   "
36075|NCT03094403|"~     A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study~   "
48466|NCT02932553|"~     The purpose of this study is to determine whether BVS(Bioresorbable Vascular Scaffold)~     implantation with optimal medical therapy can improve the outcome of patients with variant~     angina and moderate coronary artery disease.~   "
36077|NCT03094377|"~     Despite the advances in stroke rehabilitation, post-stroke upper extremity impairment is~     still a major challenge. Increasing evidence can be found supporting stimulation of the~     afferent receptor enhances neuroplasticity in the brain. Studies have suggested multisensory~     stimulation could promote motor learning by re-establishing the disrupted sensorimotor loop~     due to stroke and enhance neuroplasticity.~      The objective of the study was to examine the effect of multisensory stimulation on~     upper-extremity motor recovery and self-care function in stroke patients.~   "
36078|NCT03094364|"~     Participants will receive intensive therapy through a video game in their own homes for 1~     month. The game is operated by movements of the body (no controller needed) and acts like a~     virtual therapist. Participants will agree to play the game for 30 hours. They will also~     receive 4 home visits from a therapist designed to increase use of their arm for daily~     activities that are important to them. Participants will also receive a smart watch that will~     measure use of their weaker arm and alert them when their arm is not participating in~     activities. Arm strength and function will be measured before and after the therapy program.~   "
36079|NCT03094351|"~     This is the first randomized controlled study to compare the robot-assisted~     thoraco-laparoscopic esophagectomy (RATLE) to minimally invasive conventional~     thoraco-laparoscopic esophagectomy (CTLE). The aim of this trial is to evaluate the safety,~     risks of the robot-assisted esophagectomy, and to compare the short-term operative outcomes~     and long-term oncological outcomes between the two surgical treatments.~   "
36080|NCT03094338|"~     Education is a process of human development for quality of life. Nurse anesthetist students~     in 1-year training program have to face occasional stress perioperatively such as long and~     unpredictable working hours, exposure to chemical and radiation hazards, or the occurrence of~     unexpected death, particularly when a given patient was previously healthy. This can~     sometimes prove frustrating and may lead to unsafe practices. Students with mild to moderate~     stress, act as achievement motive, driving them to succeed their goals in learning. However,~     anyone with severe stress often fails in his or her study. If learners face tension during~     their education and they are not able to solve it instantaneously; the stress becomes a~     vicious matter.~   "
36081|NCT03094325|"~     There is no current way to monitor the depth of surgical septal myectomy during the on-pump~     period in the OR. This is because the heart is empty of blood and TEE and epicardial imaging~     is impossible. A probe device used during in neurosurgery may make the surgical procedure~     more accurate and decrease complications of too little myectomy or too much myectomy. It~     may decrease the need for reoperation which is currently a risk of myectomy 1-2%.~   "
36082|NCT03094312|"~     Epilepsy affects between 0.5 and 0.7% of the European population. Despite the availability of~     numerous drug treatments, one third of patients still have seizures, which are associated~     with significant cognitive and social complications and excess mortality. In these patients,~     surgical treatment to remove the epileptogenic zone (EZ), the region of the brain responsible~     for seizures, is the only approach that can allow control of the disease. However, before~     investigating this surgery, investigations have to answer two questions: (i) what is the~     location and extension of the EZ and (ii) what functional risks, both motor and cognitive,~     would represent the resection of this Cortical region? As it is a functional surgery, it is~     in fact inconceivable that the surgery will result in an over-handicap. For these reasons,~     all candidates for surgery benefit from a complete assessment including imaging examinations,~     a neuropsychological assessment and a long-term video-EEG recording to record seizures.~     Nevertheless, in some patients, this assessment does not give us a formal answer. In these~     subjects, it is then necessary to carry out a second step, consisting of an invasive~     exploration by implantation of intracerebral electrodes during a stereoencephalography~     (SEEG). Due to its temporal and spatial resolution, the SEEG allows, besides the precise~     determination of the EZ, to carry out a functional mapping of the cortical regions likely to~     be included in cortectomy. Conventionally, this mapping is carried out on the basis of the~     cortical electrical stimulations applied to the implanted electrodes. If this approach is~     very robust for exploring primary functions such as motor skills or language, it cannot be~     used to evaluate more complex cognitive tasks such as face recognition or attention Effective~     cognitive treatment on a daily basis. This has led to the development in recent years, in~     Lyon and Grenoble, of a complementary approach to cerebral stimulation: dynamic spectral~     imaging (ISD). Numerous experimental paradigms have demonstrated that the realization of a~     cognitive task associates with the generation within the cortical regions involved in its~     treatment of a particular cortical activity. This activity is characterized by oscillations~     of the cortical rhythm in high frequencies (> 30 Hz), called gamma activities. The ISD thus~     consists in mapping this gamma activity during various cognitive tasks, thus making it~     possible to study more widely the complexity of the cognitive functions. Correlations between~     gamma activity and cognitive tasks have so far been exclusively performed in the~     non-epileptic cortex explored at the periphery of the EA during SEEG. Nevertheless, the~     cortical oscillatory pattern study associated with a specific cognitive task within the EZ~     could better anticipate complex cognitive deficits that could be generated by the resection~     of a cortical region.~      The main objective of this project is to establish the predictive character of the gamma~     cortical oscillatory pattern associated with a specific cognitive task on the risk of~     occurrence of a cognitive disorder after surgery of epilepsy.~   "
36083|NCT03094299|"~     This study aims to evaluate the efficacy of ultrasound derived variables in prediction of~     success of weaning from mechanical ventilation in critically ill patients with abdominal~     sepsis~   "
36084|NCT03094286|"~     The proposal is a phase II clinical study designed to assess the feasibility of durvalumab~     (MEDI4736) in HIV-1-infected individuals with solid tumors. Additionally, to obtain data that~     lets understand the possible benefit of this treatment in cancer patients and HIV infection,~     exploring if activity of durvalumab (MEDI4736) could be higher in cancer that has been~     produced at least in part due to the chronic immunosupression. Simultaneously, it will allow~     us to investigate the effect of disrupting this immunoregulatory pathway might have in~     reversing cancer pathways and HIV-specific T-cell function during persistent chronic HIV~     infection in humans.~   "
36085|NCT03094273|"~     Non-interventional study to evaluate the utility of removing Dysplastic Nevi with a defined 2~     mm margin.~   "
36086|NCT03094260|"~     Binge Eating Disorder (BED) is the most widespread food behavior disorder, with prevalence~     three times higher than anorexia. Its pathophysiology remains poorly understood and the~     investigators have few therapeutic options. Following a review of the literature, the~     investigators hypothesize that luminotherapy could be an innovative treatment of BED by its~     favorable effect on triggers of hyperphagic access, circadian disturbances, attention and~     impulsivity. The study is prospective, interventional, randomized, double-blind, monocentric~     (HCL). 52 patients with BED will be randomized to an active arm with intensive luminotherapy~     (1 daily 30 min, 10,000 lux in the morning) versus a placebo arm (<500 lux). Treatment will~     be delver every day during 30 days. Assessments will take place on D0, D30 and D60. The main~     objective is to compare the evolution of the number of hyperphagic access before and after~     treatment between the two groups. Secondary objectives are to compare characteristics of~     hyperphagic access, bodily concerns, food dependence and impulsivity, mood, anxiety,~     cognitive and attentional profiles (STROOP, Go / No Go, SST, BART, Prospective Time~     Estimation Task, Switching Task), liking / wanted for different food categories and~     carbohydrate metabolism (CRP, glucose, insulinemia, insulin resistance, profile of lipid~     abnormalities, 25-OH vitamin D3).~   "
36087|NCT03094247|"~     An appropriate balance of omega-6 and omega-3 fatty acids is important for support of~     neurocognitive development in healthy infants and toddlers. In young children recovering from~     severe acute malnutrition (SAM), excess omega-6 intake depletes omega-3 fatty acid status.~     This research will evaluate how novel ready-to-use therapeutic foods (RUTF) with balanced~     fatty acids improve the metabolic and neurocognitive effects in young children in Malawi~     recovering from SAM, yielding new knowledge that also has implications for development of~     well-nourished children.~   "
36088|NCT03094234|"~     The aim of this study was to conduct a prospective randomized trial to compare TIPS with 8mm~     expanded polytetrafluoroethylene(ePTFE)-covered stents and endoscopic variceal ligation plus~     propranolol for the prevention of recurrent esophageal variceal bleeding in patients with~     Child A cirrhosis~   "
36089|NCT03094221|"~     The purpose of this study is to compare two different types of three-dimensional~     electroanatomic mapping systems used for the treatment of cardiac arrhythmias. The systems~     will be compared in regards to its ability to successfully map and ablate a clinical~     arrhythmia, as well as the time invested in this activity.~   "
36090|NCT03094208|"~     The people with transfemoral amputation who use mechanical prosthesis will be include to this~     study. All participants will be assessed and then they will be randomly assigned to two~     groups. both groups will receive traditional balance trainnig. Study group will also receive~     dual task balance training. Training will take 4 weeks, 3 days a week. After the training~     program, both groups will be assessed again and the results will compare.~   "
36092|NCT03094182|"~     The aim of this study is to evaluate the effect of Intravenous iron isomaltoside on~     maintaining hemoglobin concentration in patients undergoing bimaxillary orthognathic surgery.~     Fifty-eight patients, aged 19 to 40 years, scheduled for Bimaxillary orthognathic surgery~     will be divided into monofer (n=29) and control (n=29) groups. Randomly selected patients of~     the ulinastatin group are given intravenous iron isomaltoside. In contrast, patients in the~     control group receive an equivalent volume of normal saline as a placebo. The primary~     endpoints are postoperative hemoglobin concentration.~   "
36093|NCT03094169|"~     Approximately 80 male and female patients with documented solid tumor malignancies of~     epithelial origin that are locally advanced or metastatic, and either refractory to standard~     therapy or for whom no standard therapy is available, will be entered into this Phase 1a/2a,~     multicenter, open-label, dose-escalation, cohort study of AVID100.~   "
36094|NCT03094156|"~     The purpose of the study was to To investigate whether the administration of BIA 6-512 (25~     mg, 50 mg, 75 mg and 100 mg) at steady-state affects the pharmacokinetics of levodopa when~     administered in combination with a single-dose of immediate release levodopa/benserazide~     200/50 mg or with a single-dose of immediate release levodopa/benserazide 200/50 mg plus a~     single-dose of entacapone 200 mg.~   "
36095|NCT03094143|"~     Aortic stenosis is the most common valvular disease in the Western world. It is caused by~     progressive narrowing of the aortic valve leading to increased strain on the heart muscle~     which has to work increasingly hard to pump blood through the narrowed valve. Over time the~     heart muscle thickens to generate more force, but eventually the heart fails leading to death~     if the valve is not replaced with an operation. No medical treatments exist to stop or~     reverse the heart valve narrowing. Current clinical guidelines suggest that an operation~     should be performed only when symptoms develop or the heart muscle is visibly weak on cardiac~     ultrasound scanning. However, symptoms can be difficult to interpret and in many patients the~     heart muscle has become irreversibly damaged and the heart fails to recover following~     surgery.~      Using MRI scans of the heart, the investigators have identified heart scarring which seems to~     develop as the heart muscle thickens. Several studies now show that people who have developed~     this scarring are more likely to suffer poor outcomes including death. The investigators have~     also identified clinical risks that predict the presence of scarring.~      The investigators propose a study where patients with severe aortic stenosis but no~     indications for valve replacement as per current guidelines are assessed for those clinical~     risks. If a participant's risk of having scarring is higher they will undergo a cardiac MRI~     scan. If scarring is present participants will be randomised to routine clinical care, or~     referral for valve replacement surgery. Participants with no evidence of scarring will be~     randomised routine care with study follow or not. The investigators of this study hypothesize~     that early surgery will lead to fewer complications and reduced risk of death compared to~     standard care.~   "
36096|NCT03094130|"~     The main objective of this study is to compare the interpretation of health news items~     reporting results of phase I/II (non-randomized) trials with or without spin (i.e.,~     distortion of research results). The news items which reported studies evaluating the~     treatment effect on human health, have high number of spin in the headline and text and~     received high online public attention will be selected. Spin will be deleted and will rewrite~     the news items without spin. This sample of news items reporting results of phase I/II~     (non-randomized) trials with and without spin will be interpreted by French-speaking~     population.~   "
36097|NCT03094117|"~     The main objective of this study is to compare the interpretation of health news items~     reporting results of phase I/II (nonrandomized) trials with or without spin (i.e., distortion~     of research results). The news items which reported studies evaluating the treatment effect,~     having highest number of spin in the headline and text and received high online public~     attention will be selected. Spin will be deleted and will rewrite the news items without~     spin. This sample of news items reporting results of phase I/II (non-randomized) trials with~     and without spin will be interpreted by French-speaking patients.~   "
36098|NCT03094104|"~     The main objective of this study is to compare the interpretation of health news items~     reporting results of phase I/II (non-randomized) trials with or without spin (i.e.,~     distortion of research results). The news items which reported studies evaluating the~     treatment effect, having highest number of spin in the headline and text and received high~     online public attention will be selected. Spin will be deleted and will rewrite the news~     items without spin. This sample of news items reporting results of phase I/II~     (non-randomized) trials with and without spin will be interpreted by English-speaking~     population.~   "
36099|NCT03094091|"~     The main objective of this study is to compare the interpretation of health news items~     reporting results of phase I/II (non-randomized) trials with or without spin (i.e.,~     distortion of research results). The news items which reported those studies evaluating the~     treatment effect, having highest number of spin in the headline and text and received high~     online public attention will be selected. Spin will be deleted and will rewrite the news~     items without spin. This sample of news items reporting results of phase I/II~     (non-randomized) trials with and without spin will be interpreted by English-speaking~     patients.~   "
36100|NCT03094078|"~     The main objective of this study is to compare the interpretation of health news items~     reporting results of pre-clinical studies with or without spin (i.e., distortion of research~     results). The news items which reported those studies evaluating the treatment effect either~     in cell culture studies or animal studies, have high number of spin in the headline and text~     and received high online public attention will be selected. Spin will be deleted and will~     rewrite the news items without spin. This sample of news items reporting results of~     pre-clinical studies with and without spin will be interpreted by English-speaking patients.~   "
36101|NCT03094065|"~     The main objective of this study is to compare the interpretation of health news items~     reporting results of pre-clinical studies with or without spin (i.e., distortion of research~     results). The news items which reported those studies evaluating the treatment effect either~     in cell culture studies or animal studies, have high number of spin in the headline and text~     and received high online public attention will be selected. Spin will be deleted and will~     rewrite the news items without spin. This sample of news items reporting results of~     pre-clinical studies with and without spin will be interpreted by French-speaking patients.~   "
36102|NCT03094052|"~     This is a study to evaluate the toxicity profile of neratinib in combination with trastuzumab~     in patients with early stage breast cancer with the use of anti-diarrheal prophylaxis. The~     anti-diarrheal medications being tested in this trial are loperamide and crofelemer.~     Crofelemer is an anti-diarrheal, enteric-coated drug product for oral administration. It is~     the only botanical drug currently approved by the FDA for oral administration and is approved~     for the treatment of diarrhea associated with HAART. Crofelemer has a novel mechanism of~     action, acting directly and simultaneously on 2 distinct intestinal luminal chloride~     channels. It is an inhibitor of both the cyclic adenosine monophosphate (cAMP)-stimulated~     cystic fibrosis transmembrane conductance regulator (CFTR) chloride ion (Cl-) channel found~     on the apical membranes, and the calcium-activated Cl- channels (CaCC) at the luminal~     membrane of enterocytes. The CFTR Cl-channel and CaCC regulate Cl and fluid secretion by~     intestinal epithelial cells. Crofelemer acts by blocking Cl- secretion and accompanying high~     volume water loss in diarrhea, normalizing the flow of Cl- and water in the GI tract.~   "
36103|NCT03094039|"~     This study aims to measure the cardio-respiratory physiological consequences of initiating~     resuscitation during placental transfusion (PT) with an intact umbilical cord in infants with~     congenital diaphragmatic hernia (CDH). PT, mainly via delayed cord clamping, has been shown~     to offer a higher circulating blood volume, less need for blood transfusion, less need for~     inotropes in infants.~      Currently infants with CDH receive immediate cord clamping (ICC) to facilitate immediate~     resuscitation including immediate intubation and mechanical ventilation.~      With the development of a resuscitation platform (iNSPiRE), resuscitative care can now be~     commenced from birth in infants with CDH to benefit from PT.~   "
36104|NCT03094026|"~     A pilot study to evaluate feasibility of enrollment of patients in an intervention to improve~     neurocognitive function in hematopoietic cell transplantation (HCT) survivors using the~     cognitive training Lumosity program. In addition, patients' interest in receiving information~     regarding genetic risk of cognitive impairment post-HCT will be measured.~   "
36105|NCT03094013|"~     This study will utilize a mixed methods design featuring quantitative assessment of symptoms~     in conjunction with collecting in-depth qualitative data. In this study, perceived stress,~     mental health symptoms and behaviors and other variables will be used to test how they will~     influence the daily functioning and service utilization for adolescent and adult burn related~     injury patients at Mercy Hospital St. Louis Burn Center. The data gathered in the interviews~     will explore these constructs in-depth for the participants.~   "
36106|NCT03094000|"~     Bulimia Nervosa (BN), Binge Eating Disorder (BED) and Night Eating Syndrome (NES) are Binge~     Eating Disorders (BE-Dis) in which binge eating episodes are a main symptom. Cognitive~     Behavioral Therapy (CBT) is the leading evidence-based treatment for patients suffering from~     these disorders. CBT-E is an enhanced trans-diagnostic version of the treatment which~     appears to be more effective in a variety of Eating Disorders (EDs). The main goals of this~     treatment are reducing dietary restrictions and EDs symptoms as well as food intake~     regulation. Self-monitoring (SM) is an important and central tool in this type of treatment~     considered crucial for its success. Therefore, during treatment, patients are required to~     monitor their eating, the circumstances, and their thoughts and feelings proximate to the~     time of eating. Nevertheless, despite the importance of this tool, research has shown that~     there are many difficulties challenging the clients' adherence to SM, which might reduce this~     treatment's effectiveness and outcome. Additionally, in recent years there has been~     cumulative data supporting the use of mindfulness in the treatment of EDs. Mindfulness, as a~     western psychological approach, is defined as the unique non-judgmental focus of one's~     attention at the present moment. Although SM requires the ability to observe, describe and~     identify occurrences, no studies have yet examined the direct effect of mindfulness skills on~     SM adherence, and therefore the improvement of treatment outcomes.~      The main objective of the present study is to examine the effect of a mindfulness based~     intervention on SM adherence during a CBT intervention for BE-Dis, and on the treatment~     outcomes as seen in the ED psychopathology and compliance to the nutritional instructions and~     food intake composition. Other aims include examining the differences between the~     experimental group and the control group, regarding their level of mindfulness and SM~     adherence. In addition, mediating and moderating processes between mindfulness and SM~     adherence will be examined.~   "
36107|NCT03093987|"~     Objective~      To investigate whether critical care ultrasound oriented shock management in shock patients~     in intensive care unit(ICU) can improve outcome.~      Methods~      Randomized controlled research. Patients were randomly allocated to two groups. In the~     critical care ultrasound oriented shock management group (CUSS group), treatment was oriented~     by the findings of critical care ultrasound in each shock phase, while in the control group~     the decisions about the monitoring and management were made by the clinical team. The goal of~     treatments in both groups were decreasing lactate by 20% or more per 2 hours for the~     Optimization phase in shock management, and no increase lactate level when removing the fluid~     in de-escalation phase. The primary outcome measure were hospital mortality and 28-day~     mortality, the secondary outcome measure were the length of ventilation and the length of ICU~     stay.~   "
36108|NCT03093974|"~     The purpose of the trial is to investigate if the use of inhaled colistimethate sodium~     administered twice daily for 12 months delays the time to the first pulmonary exacerbation~     compared to placebo in subjects with non-cystic fibrosis (CF) bronchiectasis chronically~     infected with P. aeruginosa~   "
36109|NCT03093961|"~     The objective of this pilot study is to evaluate the safety and performance of implanting the~     IASD® System II in Heart Failure patients with reduced ejection fraction and elevated left~     sided filling pressures, who remain symptomatic despite Guideline Directed Medical Therapy~     (GDMT).~   "
36110|NCT03093948|"~     Ischemia-reperfusion leads to mitochondrial injury, ion-pump injury, cell membrane damage,~     cytotoxic edema, and excessive oxygen free radical formation, and eventually destroys cells.~     Cardiac arrest is an example of global ischemia; after spontaneous circulation is restored,~     ischemia-reperfusion injury develops in cardiac arrest survivors.~      Remote ischemic postconditioning (RIPoC) involves the application of brief, reversible~     episodes of ischemia and reperfusion to a vascular bed or tissue, rendering remote tissues~     and organs resistant to ischemia-reperfusion injury. Accordingly, RIPoC has been suggested as~     adjunctive therapy to mitigate ischemia-reperfusion injury. RIPoC applied by repeated brief~     inflation-deflation of a blood pressure cuff protects against myocardial injury, and has been~     proven effective in acute myocardial infarction.~      This study aims to perform a randomized controlled trial to determine whether RIPoC has a~     neuroprotective effect and aids in myocardial recovery in out-of-hospital cardiac arrest~     patients after restoration of spontaneous circulation.~      Neuron-specific enolase (NSE) at 48 hours after restoration of spontaneous circulation will~     be measured as a primary outcome.~   "
37574|NCT03074812|"~     This study evaluates the effect of transcranial direct current stimulation (tDCS) on~     non-motor symptoms of Parkinson's disease, including depression and cognitive symptoms.~     Participants are randomized to receive active or sham tDCS for 30 minutes over 10 treatment~     sessions.~   "
36111|NCT03093935|"~     StimRouter Neuromodulation System includes an implanted lead which provides peripheral nerve~     stimulation for chronic pain. Post-stroke shoulder pain patients will be the focus of this~     study. After meeting inclusion/exclusion criteria, approximately 50 enrolled patients will~     participate in the study through 6 months of follow-up. Various measures will be used to~     assess patient response to use of the device.~   "
36112|NCT03093922|"~     The purpose of this study is to compare any good and bad effects the study drug atezolizumab~     has on the cancer when combined with the standard chemotherapy drugs gemcitabine and~     cisplatin (or GC) in two different dosing schedules: chemotherapy (GC) before atezolizumab~     vs. GC after atezolizumab.~   "
36113|NCT03093909|"~     Any time the words you, your, I, or me appear, it is meant to apply to the potential~     participant.~      The goal of this clinical research study is to find the highest tolerable dose of gemcitabine~     that can be given by inhalation (breathing it as a mist) to patients with solid tumors that~     have spread to the lungs from other parts of the body.~      The safety and side effects of this drug will also be studied.~      This is an investigational study. Gemcitabine is FDA approved and commercially available for~     the treatment of pancreatic and lung cancer, and other solid tumors. Its administration by~     inhalation is investigational. The study doctor can explain how the study drug is designed to~     work.~      Up to 44 participants will be enrolled in this study. All will take part at MD Anderson.~   "
36114|NCT03093896|"~     Cognitive impairment is also a major risk factor for development of dementia later in life.~     Findings from recent studies suggest that the there are many nutrients contained in foods~     that may be important in cognitive function in the elderly. This study evaluates long-term~     intervention with almonds and snack mix as a treatment strategy for age-related cognitive~     impairment which could possibly prevent the onset of dementia.~      The proposed study is designed as a randomized, placebo controlled trial that tests the~     effects of 6 month supplementation with 1.5 or 3 ounces of almonds or 3 ounces of shortbread~     containing coconut oil on cognitive function in older adults. Secondary outcomes include~     plasma biomarkers of oxidative stress and inflammation.~   "
36115|NCT03093883|"~     The aim of this pharmacokinetic study is to assess the bioequivalence of the generic~     Ferrinemia® Iron Sucrose injection solution 20 mg/mL manufactured by Help S.A., Greece (test~     product), to Venofer® Iron Sucrose injection solution 20 mg/mL manufactured by Vifor AG,~     Switzerland (reference product). Both formulations contain iron as an active ingredient.~     Intravenous iron sucrose is primarily indicated for the treatment of iron deficiency anemia~     in adult patients.~   "
36116|NCT03093870|"~     This protocol for Varlitinib is developed for the treatment of Biliary Tract Cancer.~     Varlitinib (also known as ASLAN001) is a small-molecule, adenosine triphosphate competitive~     inhibitor of the tyrosine kinases - epidermal growth factor receptor (EGFR), human epidermal~     growth factor receptor (HER)2, and HER4. Varlitinib may be beneficial to subjects with cancer~     by simultaneous inhibition of these receptors. The purpose of this study is to determine the~     safety and efficacy of Varlitinib in combination with capecitabine for the treatment of~     Biliary Tract Cancer. Treatment groups are Varlitinib+capecitabine and Placebo + capecitabine~   "
36117|NCT03093857|"~     Patients with a thoracoabdominal aortic aneurysm in need of an endovascular or open operative~     restructuring will be asked to participate in this study. After obtaining written consent a~     central venous catheter and a liquor drainage will be routinely placed during surgery. The~     catheter and the drainage will stay in the patients for at least 72 hours postoperatively. In~     total, nine measurements of the liquor and serum will be performed within a week in order to~     determine the following parameters: neuropeptide P, neuropeptide Y, neurofilament triplet~     protein (NFL), S100B, glial fibrillary protein (GFAp), lactate, glucose, or oxygen.~   "
36118|NCT03093844|"~     This is a study to evaluate the safety and efficacy of Miltenyi CliniMACS® CD34 Reagent~     System to promote engraftment of haploidentical CD34+ selected cells combined with single~     unit umbilical cord blood transplant for treatment of high-risk hematologic disorders.~   "
36119|NCT03093831|"~     The purpose of this study is to assess the efficacy and safety of Ibrutinib in predominantly~     Asian patients with relapsed or refractory marginal zone lymphoma.~   "
36120|NCT03093818|"~     PREPARE is an international, prospective, multi-center, open, randomized, cross-over~     implementation study assessing the impact of pre-emptive pharmacogenomic testing, of a panel~     of actionable pharmacogenomic variants, on adverse event incidence. Additional outcomes~     include, healthcare expenditure, process indicators for implementation and provider adoption~     of pharmacogenomics.~   "
36121|NCT03093805|"~     The purpose of this study is to evaluate the efficacy of Calcipotriene cream. This is a~     synthetic vitamin D3 derivative for topical use. It is used to treat grade 1-3 acute skin~     graft versus host disease (GVHD) in hematopoietic stem cell transplant (HSCT) recipients.~     Calcipotriene will be used as the exclusive topical therapy in addition to standard of care~     GVHD treatment prescribed for the study subject by the primary physician.~   "
36122|NCT03093792|"~     The purpose of this study is to look at the effects of a carbohydrate restricted, high~     protein, high fat diet on weight loss and health outcomes in women participating in the~     Curves Fitness and Weight Loss Program.~   "
36134|NCT03093636|"~     The purpose of this study is to reduce the frequency of hypoglycemia and severe hypoglycemic~     events in subjects who use insulin pens to treat their Type 1 Diabetes Mellitus (T1DM).~     Hypoglycemia is the number one fear of many individuals and families with someone who has~     type 1 diabetes, and this fear often prevents optimal glycemic control. It is expected that~     this protocol will yield increased knowledge about using a decision support system to help~     control the glucose level.~   "
36135|NCT03093623|"~     In this proposed project,investigators will estimate the effect of physical activity and~     abstain from smoking on the regression of precancerous neoplasia.~   "
36266|NCT03091907|"~     Aim~      The aim of this study is to determine consequences at school age of the diagnosis of NEC in~     the neonatal period.~      Methods~      This is a case-control study, with case-group being children born in Denmark with a history~     of NEC and control-group being age-, gestational age- and year of birth matched children born~     in Denmark with no history of NEC.~      Primary outcome~      Abnormal or borderline 'total difficulties score' in the~     strenghts-and-difficulties-questionnaire as assessed by parents.~   "
36123|NCT03093779|"~     The purpose of this proposal is to examine the attitudes, knowledge, and skills related to~     health information that influence health literacy among Deaf individuals.The study team will~     also examine frequently overlooked potential predictors of health literacy, including~     cognitive abilities, resilience, and self-efficacy. To achieve the study objectives,~     researchers will conduct an explanatory sequential mixed methods design using extensive~     quantitative data collection procedures, namely, cross-sectional surveys and measures that~     will identify predictors and moderators of health literacy with Deaf and hearing subjects.~     These results will inform the subsequent qualitative assessment using elicitation interviews~     that will help explain the quantitative results, and elucidate how and why Deaf individuals~     access and understand health information. A community advisory board consisting of Deaf~     community members will provide oversight to the proposal that will be led by multiple Deaf~     investigators, including the PI. The Deaf community, due to communication barriers, relative~     social marginalization, and their reliance on visual learning, provides a unique insight into~     how health information is distributed and disseminated visually. Findings may be applicable~     to other individuals with hearing loss who navigate and cope with life more visually than the~     typical hearing person. This will be critical to determine more accurately the effect of~     visual learning and existing online health information on health literacy.~   "
36124|NCT03093766|"~     The goal of this study is to find differences between patients who do and do not develop~     ICU-acquired hypernatremia (IAH). Therefore extended sodium and fluid balances will be~     performed. Also a couple of other factors that possibly contribute to the development of IAH~     and/or could give clues about the mechanisms in the development of IAH will be investigated.~   "
36125|NCT03093753|"~     Consumption of carbohydrate containing foods or sugary drinks brings about changes to the~     blood glucose levels. After a meal or drink, blood glucose rises until it reaches a peak~     concentration usually after 30 minutes. When the body senses the increase in blood glucose, a~     hormonal process involving insulin takes place to ensure that the glucose is taken up from~     the blood for storage and where it is needed for energy in the body. This process then brings~     about a decrease in the concentration of glucose until it reaches approximately the starting~     concentration. The original concentration of glucose is attained approximately 2 hours after~     eating or drinking a carbohydrate food or sugary drink respectively in healthy people.~      Different carbohydrates and sugary drinks have different effects on blood glucose response~     depending on the amount as well as the type of carbohydrate. Those that give rise to a high~     glucose response compared to a reference carbohydrate (usually glucose) are said to be high~     glycaemic index (GI) foods and those with a lower glucose response compared to a reference~     carbohydrate (usually glucose) are said to be low glycaemic index (GI) foods.~      Research has shown that diets that give rise to a high glucose response are associated with a~     number of abnormalities like increased risk of metabolic syndrome. Metabolic syndrome mostly~     comprises of insulin resistance and glucose intolerance which gives an increased risk of type~     2 diabetes. It also gives rise to other conditions like high blood pressure (arterial~     hypertension), elevated blood insulin levels (hyper-insulinemia), elevated amounts of fat in~     the liver (fatty hepatosis) and elevated amounts of lipids in the blood (dyslipidemia). After~     type 2 diabetes become clinically apparent, the risk of cardiovascular disease also rises.~     Research has also shown that foods/drinks which raise blood glucose levels gradually (low GI)~     rather than rapidly (high GI) have health benefits which include reducing the risk of~     metabolic syndrome. Laboratory studies have shown that polyphenols found in fruits,~     vegetables and plant based foods have a positive effect on carbohydrate metabolism and can~     lower the blood glucose levels.~      This research will determine whether the presence of polyphenols in the diet has any lowering~     effect on the blood glucose levels and hence the glycaemic index of foods. This will be~     determined by asking volunteers to consume pomegranate polyphenols together with different~     carbohydrate sources which will define the 6 different interventions. The blood glucose~     response of bread will be determined initially as a control reference. All meals will be~     consumed in random order.~      Analysis will be done by measuring blood glucose response after consumption of the control~     reference meal and the test meal containing polyphenols and then determining the incremental~     area under the glucose curve.~      THE SIX DIFFERENT INTERVENTIONS MAY OR MAY NOT BE COMBINED FOR PURPOSES OF PUBLISHING~     RESULTS. EACH INTERVENTION WILL AIM TO HAVE AT LEAST 10 PARTICIPANTS.~   "
36126|NCT03093740|"~     Open label single center study for the donation of HCV positive kidneys to HCV negative~     recipients with interventional treatment to prevent HCV transmission upon transplantation.~   "
36127|NCT03093727|"~     Very recent studies indicate that a high percentage of HCL, about 50%, have mutations in the~     B-RAF oncogene. The development of ultrasensitive methodologies capable of identifying these~     mutations in bronchoalveolar lavage will represent a significant advance in the diagnosis and~     treatment of these patients. An undetermined percentage of HCL does not present mutations in~     B-RAF. Consequently, the deep genetic analysis, through the use of techniques of massive~     sequencing, can favor the identification of new alterations that contribute to the~     development of the disease.~      We hypothesized that patients with HCL may present a different inflammatory state to healthy~     subjects or smokers, allowing us to identify new biomarkers.~   "
36128|NCT03093714|"~     This is a multicenter, randomized, placebo-controlled, dose-escalation study. Enrollment is~     planned to occur at approximately 14 global sites. Approximately 24 subjects with CF.~   "
36129|NCT03093701|"~     Subjects with macular edema will be screened and eligible subject will be enrolled to receive~     a single dose of the study drug (TLC399) with either of the three dose strengths by~     intravitreal (IVT) route. Each of the three groups will include approximately 22 subjects.~     The subjects will be followed for visual acuity, safety, tolerability and retinal thickness~     assessment after the single IVT injection of the study drug on Day 1.~   "
36130|NCT03093688|"~     Invariant Natural killer T (iNKT) cells are a unique subset of lymphocytes that express~     homogeneous TCR recognizing KRN7000 which was up-regulated by many kinds of cancer cells.~     PD-1+CD8+T cells of patients with advanced tumor are most likely tumor-specified. Our~     hypothesis is that immunotherapy strategy of infusion of iNKT cells and PD-1+CD8+T cells may~     decrease the tumor burden and improve overall survival. The purpose of this study is to~     assess the safety and efficacy of treatment of patients with advanced solid tumor by infusing~     of iNKT cells and PD-1+CD8+T cells.~   "
36131|NCT03093675|"~     This is a prospective, single-center clinical trial. One hundred and fifty patients affected~     by adnexal and uterine diseases will be recruited to undergo treatment with robotic assisted~     laparoscopic procedures using the innovative TELELAP ALF-X Endoscopic Robotic Surgical System~     with the primary objective of assessing the feasibility, efficacy and safety of this~     approach.~   "
36132|NCT03093662|"~     This is a prospective randomized cross over study of healthy volunteers comparing end-tidal~     oxygen concentration among subjects undergoing continuous positive airway pressure~     ventilation via a noninvasive ventilation (NIV) mask with and without the addition of nasal~     cannulas.~   "
36133|NCT03093649|"~     Although patient-reported adverse events have been promoted as an essential element in~     clinical trials and daily managements, their efficacy remained unknown. The purpose of this~     trial was to determine the effect of the patient-reported adverse events during the treatment~     on the improvements on quality of life.~   "
36267|NCT03091894|"~     This study evaluate the effect of adding dexmedetomidine intravenous infusion to propofol~     intravenous infusion during sedation for drug induced sleep endoscopy. Twenty five patients~     will receive propofol only while the other twenty five will receive propofol and~     dexmedetomidine.~   "
36136|NCT03093610|"~     Previous studies have shown that the removal of the chest tube after lung surgery~     significantly improves pain symptoms and lung function. The criteria for chest tube removal~     still remain vague in modern thoracic surgery and rely on personal experience instead of~     evidence-based criteria. Every hospital has its own traditional standard fluid threshold and~     believes in that without adapting and comparing it not even after introduction of newer and~     more minimal-invasive operation technique. According to literature the traditional fluid~     threshold is varying from 100 to 500 or even more millilitre in 24 hours. Since pleural fluid~     resorption is proportional to body weight the investigators believe that a body weight~     related approach of chest tube management would improve safety and would allow an earlier~     chest tube removal without a higher rate of complication. In this way the investigators~     believe in improving pain management and in achieving earlier discharge of the patient.~   "
36137|NCT03093597|"~     The purpose of the study is to compare the changes in the appearance of dry skin after the~     use various moisturizers: white petrolatum ointment, coconut oil, jojoba oil, and almond oil~     in patients with dry skin.~   "
36138|NCT03093584|"~     Title of the study: Auricular acupuncture (AA) vs. expressive writing for pre-exam anxiety -~     a randomised crossover study~      Study period: 04 / 2014 - 07 / 2014~      Principal Investigator: Prof. Dr. T. Usichenko Department of Anaesthesiology and Intensive~     Care Medicine University Medicine of Greifswald~      Aim of the study: To investigate the anxiolytic effect of AA vs. expressive writing and vs.~     no intervention in students, passing the oral exams in anatomy at the University of~     Greifswald~      Design: Prospective randomised crossover trial~      Interventions: 1. AA using indwelling fixed needles, retained 24 h in situ 2. Expressive~     writing~      Number of volunteers: N = 40~      Healthy medical students at the University of Greifswald Participants of the anatomy exams in~     spring/summer 2014 Without previous anxiolytic, sedative and analgesic medication No~     pregnancy or lactating Informed consent~      Outcome measures: Anxiety level Heart rate, blood pressure Salivary α-amylase~   "
36139|NCT03093571|"~     Title of the study: Auricular acupuncture (AA) vs. progressive muscle relaxation for pre-exam~     anxiety - a randomised crossover study~      Study period: 04 / 2015 - 07 / 2015~      Principal Investigator: PD Dr. T. Usichenko Department of Anaesthesiology and Intensive Care,~     University Medicine of Greifswald~      Aim of the study: To investigate the anxiolytic effect of AA vs. progressive muscle~     relaxation and vs. no intervention in students, passing the oral exams in anatomy at the~     University of Greifswald~      Design: Prospective randomised crossover trial~      Interventions: 1. AA using indwelling fixed needles, retained 24 h in situ 2. Progressive~     muscle relaxation~      Number of volunteers: N = 30~      Healthy medical students at the University of Greifswald Participants of the oral anatomy~     exams in spring/summer 2015 Without previous anxiolytic, sedative and analgesic medication No~     pregnancy or lactating Informed consent~      Outcome measures: Anxiety level Heart rate, blood pressure Salivary α-amylase~   "
36140|NCT03093558|"~     AF is associated with significant social and medical costs, including diminished quality of~     life (QOL) and increased health care utilization (HCU). This pilot study will enroll 200~     adults with prevalent, non-valvular AF of ≤3 year's duration at University of Pittsburgh~     Medical Center (UPMC). The primary objective at present is to obtain extensive feasibility~     and pilot data in implementing the Embodied Conversational Agent (ECA) in concert with the~     Kardia (KAC) heart rhythm monitor.~   "
36141|NCT03093545|"~     A single center, prospective cohort, open-label study of rabies post exposure program with~     equine rabies immunoglobulin (ERIG) and purified chick-embryo cell (PCEC) rabies vaccine in~     WHO category III exposed patients at Siriraj Hospital, Thailand aims to compare serum RVNA~     responses between obese (BMI > 30 kg/m2) and normal weight/underweight (BMI < 25 kg/m2) and~     to evaluate adverse events occurring after immunization on days 7, 14 and 28.~   "
36142|NCT03093532|"~     Effective interventions that can address uncontrolled hypertension, particularly in~     underrepresented populations that use the emergency department (ED) for primary care, are~     critically needed. Uncontrolled hypertension (HTN) contributes significantly to~     cardiovascular morbidity and mortality and is more frequently encountered among patients~     presenting to the ED as compared to the primary care setting. EDs serve as the point of entry~     into the health care system for many high-risk patient populations, including minority and~     low-income patients. Based upon recent studies, the prevalence of uncontrolled/undiagnosed~     HTN in patients presenting to the ED is alarmingly high.~      Thus emergency department engagement and early risk assessment/stratification is a feasible~     innovation to help close health disparity gaps in HTN.~      This proposal involves a three-arm randomized controlled trial of 120 patients from the~     Emergency Department at University of Illinois Hospital with elevated blood pressure (BP) and~     no established primary care provider (PCP). The overarching goal is to improve follow-up~     rates and transition to PCP care at a federally qualified community health center (FQHC). The~     primary outcome will be blood pressure control. Secondary outcomes will be blood pressure~     improvement, treatment adherence, and hypertension knowledge. The central hypothesis of the~     proposal is that an ED-based screening, brief intervention, and referral for treatment~     program for HTN (SBIRT-HTN) using existing ED resources, coupled with a follow-up visit to an~     ED pharmacist-initiated Post-Acute Care Hypertension Transition Clinic (PACHT-c), can be~     impactful in a predominately underrepresented hypertensive population.~   "
36143|NCT03093519|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of~     KHK6640, given as a repeated dose in Japanese patients with Mild to Moderate Alzheimer's~     Disease.~   "
36144|NCT03093506|"~     A recent study by Plenge et al. revealed that rhEpo treatment enhances skeletal muscle~     mitochondrial respiratory capacity in humans indicating a muscle ergogenic effect of rhEpo on~     aerobic metabolism. The main purpose of the present study is to determine if a shorter~     treatment period with micro-dose as well as low-dose rhEpo has similar effects on muscle~     mitochondrial function.~      Higher doses of rhEpo is known to increase cognitive performance, but it is not clear if~     lower doses of rhEpo have similar effects. A second purpose of the present study is to~     determine if micro-dose as well as low-dose rhEpo increases cognitive performance.~   "
36203|NCT03092739|"~     The primary purpose of this non-interventional, multinational study is to assess the~     feasibility of assessing PD-L1 protein expression on cytological samples as a surrogate for~     histological samples obtained from participants with any stage of non-small cell lung cancer~     (NSCLC) or small cell lung cancer (SCLC).~   "
36145|NCT03093493|"~     We are planning to collected blood and saliva for DNA extraction to use for genetic testing~     of children and adults with EDS and their relatives. Medical records from other institutions~     and clinical notes for visits in Dr. Holick's clinic will be reviewed to obtain the following~     information: previous diagnosis at other institutions, age, clinical signs and symptoms of~     EDS, Joints Hypermobility Syndrome (JHS), , and other metabolic or genetic disorders and~     laboratory results, radiology reports and images, and genetic testing that supports these~     diagnoses. Subjects' peripheral vein blood and saliva will be taken. No clinical~     intervention/randomizations will be performed. No patients' identifiers will be reported.~      In this pilot study genomic DNA will be extracted and will be used for genotyping as~     sequencing in 30 EDS patients and their 30 relatives with or without EDS to compare genetic~     variations between them. After validation by Sanger sequencing for these variations, we plan~     to prepare a genetic panel for EDS. After all validation testing, we plan to evaluate the~     saliva DNA in a similar manner and compare the results with those obtained from the DNA from~     the blood sample. The purpose is that if they are comparable, we will be able to use saliva~     in place of blood as it easier method for accessing a person's DNA. This will be especially~     helpful for evaluating infants or those patients who prefer not to have a blood sample drawn.~     NOTE: Results of this study will not be disclosed to subjects.~   "
36146|NCT03093480|"~     The primary purpose of this study is to describe the time to tolerization with rFVIIIFc in~     participants within a maximum of 12 months of ITI treatment.~   "
36147|NCT03093467|"~     Depression is a highly prevalent disorder in Chile, generating important personal and social~     costs. This study aims to evaluate the effectiveness of the internet-based program ASCENSO as~     an adjunct intervention for the treatment of depression. ASCENSO provides information to~     promote patients' self-care, it monitors reported depression symptoms providing automatized~     feedback and provides the possibility of booking a counseling session via chat or by phone.~     To evaluate the effectiveness of ASCENSO, an open, evaluator-blind, prospective,~     parallel-group (one intervention group and one active control group) randomized controlled~     trial will be implemented in one mental health center in Santiago of Chile. The sample will~     be composed of adults initiating treatment for depression, and who have internet access.~     Participants will be randomly assigned to one of the two study arms. Randomization will be~     stratified by the number of patients´ previous episodes (dichotomized into none, 1 or more),~     following a permuted block randomization procedure. Patients in the experimental group~     (n=100) will receive the usual treatment plus access to the ASCENSO program. The control~     group (n=100) will only receive the usual treatment. At recruitment, months 6 and 9,~     patients' self-reported depression symptoms and quality of life will be assessed.~     Additionally, adherence to treatment in terms of patients' attendance to medical controls and~     psychotherapy sessions will be registered for both research groups.~   "
36148|NCT03093454|"~     This project will evaluate the integration of lavender essential oil in surgical patients~     during the perioperative and postoperative phase of care. The study will assess patients'~     pain, sleep quality, and mood. The goal is to support that lavender oil will decrease pain~     scores and narcotic use, increase sleep quality, and decrease anxiety by improving overall~     patient satisfaction and supporting their natural sense of well being. This research project~     will help support the use of complementary medicine in a hospital setting. The increased~     awareness and use of complementary medicine in a hospital setting will strengthen the patient~     centered care model that all hospitals strive to achieve.~   "
36149|NCT03093441|"~     Recently, it has been demonstrated that multimodal high-intensity interval training (MM-HIIT)~     (utilizing resistance-based and functional movements) can produce similar aerobic adaptations~     compared to high-intensity interval training (HIIT) using rowing but with greater muscle~     performance in females. In addition, HIIT has been shown to be more enjoyable than continuous~     training, and this may lead to enhanced self-efficacy and increased physical activity. To the~     investigators' knowledge, however, the cardiometabolic effects (blood pressure,~     abdominal/visceral fat, blood sugar, blood lipids/fats) of MM-HIIT have not been reported.~     The investigators aim to compare MM-HIIT with HIIT using a traditional aerobic fitness~     exercise (rowing) for the degree of cardiometabolic, physical performance (strength,~     endurance, power), and psychosocial (self-efficacy and enjoyment) adaptations.~   "
36150|NCT03093428|"~     This research study is studying the safety and tolerability of an investigational combination~     of drugs, radium-223 plus pembrolizumab as a possible treatment for castration-resistant~     prostate cancer.~      The interventions involved in this study are:~        -  Radium-223~        -  Pembrolizumab~   "
36151|NCT03093415|"~     hepatitis C virus (HCV) has traditionally been treated in subspecialty health centers given~     the complexity of older pegylated interferon containing regimens, formerly the standard of~     care. This model has persisted into the modern era of direct anti-viral agents (DAAs) despite~     their relative simplicity, creating a bottleneck of human resources necessary to fight the~     largest infectious epidemic in North America. In addition, stigma and fear over cost has lead~     payers to restrict treatment in People Who Inject Drugs (PWIDs), even though a majority of~     new infections occur in this population.~      This study evaluates the effectiveness of treatment of HCV with elbasvir-grasoprevir in PWIDs~     in a real world, community health clinic setting.~      There are two prospective cohorts of PWIDs of 25 patients each, both in primary care-based~     community health clinics in Portland, Oregon. Cohort one is actively engaged with ambulatory~     medication assisted therapy with buprenorphine or extended released injectable naltrexone.~     Cohort two maintains active injection drug use with needle exchange and risk reduction~     education.~      These groups are compared to a 50 patient retrospective cohort of people with substance use~     disorders at tertiary care hepatology-based treatment program.~      All patients have genotype 1 or 4 HCV and are treated with elbasvir-grasoprevir for 12 weeks.~      The investigators hypothesize there is no difference in sustained viremic response at 12 or~     48 weeks post-completion of treatment (SVR 12, 48) when treating patients in a community~     health clinic setting as compared to the standard-of-care subspecialty setting.~   "
36204|NCT03092726|"~     The purpose of this study is to assess analgesic efficacy of ASP8062 relative to placebo as~     well as the safety and tolerability. This study will also assess the treatment differences in~     physical function as well the improvements in overall subject status (e.g., fibromyalgia~     symptoms, global functioning) of ASP8062 relative to placebo.~   "
36152|NCT03093402|"~     The objective of this study is to evaluate the efficacy, safety, and tolerability of JBT-101~     (also known as lenabasum) in systemic lupus erythematosus (SLE).~        -  One hundred adults with active joint disease and at least moderate pain will be enrolled~          in this study to evaluate treatment of their systemic lupus erythematosus (SLE) with~          JBT-101. JBT-101 is a synthetic endocannabinoid receptor type 2 (CB2) agonist and an~          activator of the body's normal processes, to resolve innate immune responses without~          immunosuppression.~        -  Participants will receive 2 doses of JBT-101 by mouth (three groups of varying doses)~          or, placebo, for 84 days and will continue to be followed for an additional 28 days.~          Participant visits to assess endpoints occur on Day 1, then every 2 weeks twice, then~          every 4 weeks three times, for a total of six visits.~        -  The change in maximum daily pain Numerical Rating Scale (NRS) score from Baseline (Visit~          1) will be assessed at every visit.~   "
36153|NCT03093389|"~     To investigate the tolerability and safety of four multiple-dose regimens of BIA 6-512 (25~     mg, 50 mg, 100 mg, and 150 mg 6 times daily) in healthy volunteers and to characterise the~     steady-state pharmacokinetic profiles of BIA 6-512 (25 mg, 50 mg, 100 mg, and 150 mg 6 times~     daily) in healthy volunteers.~   "
36154|NCT03093376|"~     Clinically significant anxiety affects up to 20% of preschool-aged children and often fails~     to respond to currently available treatments. Emerging science suggests that increasing brain~     capacity for effortful control (EC) may help anxious children to regulate emotion and~     behavior to improve outcomes. Thus, in the proposed study, children will be trained on EC~     tasks (including selective attention, response inhibition, etc.) to increase capacity for~     effortful control (EC) over fear behaviors. To determine whether EC training improves brain~     capacity to regulate fear, investigators will assess neurophysiological and behavioral~     indices of effortful control and fear reactivity before and after this training.~   "
36155|NCT03093363|"~     The impact of a pharmacist's intervention on asthma control has now been well demonstrated,~     but its effect on inflammatory markers of FENO (Fractional exhaled nitric oxide) in asthmatic~     patients has been little studied in the literature. The aim of this study is to investigate~     the impact of a pharmacist's intervention on FENO in patients seen in clinical practice by a~     pneumologist in a secondary university center.~   "
36156|NCT03093350|"~     The study is being conducted in patients in which breast cancer has come back after standard~     treatment. Volunteers in this research study are treated using special immune system cells~     called tumor-associated antigen (TAA)-specific cytotoxic T lymphocytes, a new experimental~     therapy.~      The proteins that investigators are targeting in this study are called tumor-associated~     antigens (TAAs). These are cell proteins that are specific to the cancer cell. They do not~     show, or they show up in low quantities, on normal human cells. In this study, investigators~     target five common TAAs. They are called NY-ESO-1, MAGEA4, PRAME, Survivin and SSX2. On a~     different study, patients have been treated and so far this treatment has shown to be safe.~      Investigators now want to try this treatment in patients with breast cancer.~      These TAA-specific cytotoxic T lymphocytes (TAA-CTLs) are an investigational product not~     approved by the Food and Drug Administration.~      The purpose of this study is to determine the clinical efficacy of TAA-specific CTLs, to~     learn what the side-effects are, and to see whether this therapy might help patients with~     breast cancer.~   "
36157|NCT03093337|"~     Our current reflexion is that sensory dys-stimulations, including vestibule-proprioceptive~     disorders and unbalanced between brain and brainstem maturation of the neonatal period~     involve an early deviant development for immature infants that will be cascaded through the~     brain scaffolding and later development. The primary purpose is to determine whether the~     Early Psychomotor Therapy Intervention Program improves development and behavior in very~     preterm infants (VPI) at 24-month corrected age (CA).~   "
36158|NCT03093324|"~     This study will assess the gastrointestinal (GI) tolerability of ALKS 8700 in adult subjects~     with RRMS~   "
36159|NCT03093311|"~     The occurrence of postoperative cognitive dysfunction (POCD) might be related to~     intraoperative cerebral desaturation. Positioning for neurosurgical procedures are associated~     with head rotation, elevation, flexion or extention that may affect blood brain inflow and~     outflow. Anatomical variations of Willis circle could affect the cerebral blood flow in~     extreme head position with the development of cerebral ischemia or functional changes of~     brain. Investigators suppose that detection of cerebral tissue desaturation and its prompt~     correction could modify the occurence of POCD after these procedures.~   "
36160|NCT03093298|"~     Examination of the molecular phenotype and composition of endocrine cells in the~     gastrointestinal tract correlated to analyses of blood for hormones/analytes before and after~     Roux-en-Y gastric bypass surgery in morbidly obese individuals both with and without type 2~     diabetes~   "
36161|NCT03093285|"~     The aim of the study is to evaluate the incidence of sexual dysfunction in presence of~     dysthyroidism and the impact of restoring euthyroidism on female sexual function~   "
36162|NCT03093272|"~     This research study is studying a combination of drugs as a possible treatment for~     castration-resistant prostate cancer.~      The interventions involved in this study are:~        -  Docetaxel (a type of chemotherapy)~        -  Apalutamide (the study medication, also known as ARN-509)~        -  Prednisone (a corticosteroid given to prevent reactions to docetaxel).~        -  Leuprolide acetate (also known as Lupron, a GnRH agonist or similar drug which is~          standard of care, causes chemical castration which greatly lowers the level of~          testosterone in the body)~   "
36163|NCT03093259|"~     This Phase IIa study is an 8-week, double-blind, placebo-controlled, randomized study aiming~     at evaluating the safety and the efficacy of ABX464 given once a day (o.d) at 50 mg in~     subjects with moderate to severe Active Ulcerative Colitis who have failed or are intolerant~     to immunomodulators, Anti-TNFα, vedolizumab and/or corticosteroids followed by a one-month~     follow-up period.~   "
36164|NCT03093246|"~     The aim of this randomized controlled clinical trial of superiority will be to evaluate the~     effect of 3 g of omega-3 polyunsaturated fatty acids and 100 mg of aspirin daily~     supplementation over a period of 180 days as adjunct to non-surgical therapY of patients with~     generalized aggressive periodontitis. Probing depth, clinical attachment level, gingival~     index and concentration of microorganisms and cytokines at baseline, 3, and 6 12 months after~     the procedure will be evaluated.~   "
36165|NCT03093233|"~     Intracerebral hemorrhage [ICH] is the most feared complication of oral anticoagulation [OAC],~     yet therapeutic strategies are limited reflected by overall weak guideline recommendations.~     Studies investigating acute interventions especially in patients with ICH taking~     non-vitamin-K-oral-anticoagulants [NOAC] remain inconclusive. Further, acute management~     issues in OAC-ICH patients (hematoma evacuation surgery, prevention of acute thromboembolic~     events, intraventricular fibrinolysis) still need to be investigated. Therefore, this~     observational study (RETRACE-II) represents the follow-up investigation to RETRACE~     (German-wide Multicenter Analysis of Oral Anticoagulant-associated Intracerebral Hemorrhage,~     study-period 2006-2010, NCT01829581), now spanning a study-period from 2011 until 2015 with~     19 participating tertiary care centers nation-wide in Germany. Data pooling of the two~     RETRACE studies, altogether including more than 2500 patients treated at 22 centers over a 10~     year period will allow statistically appropriate analyses of different outcomes.~   "
36166|NCT03093220|"~     Community-acquired pneumonia (CAP) is a heterogeneous disease causing great morbidity,~     mortality and health care burden globally. Typing methods for discriminating different~     clinical conditions of the same disease are essential to a better management of CAP.~     Traditional typing systems based separately on clinical manifestations (such as PSI and~     CURB-65), pathogens(bacterial types, virulence, drug resistance, etc) or host immune state~     (immunocompetent, immunocompromised or immunodeficiency). Thus, they are barely able to~     represent the real disease status nor to precisely predict the mortality.~      As the development of multi-omic technologies, the relatedness of different phenotypes at a~     molecular level have revolutionized our ability to differentiate among patients. Our study is~     aimed at establishing a novel molecular typing method of CAP. Multi-omic (including genomics,~     transcriptomes, and metabolisms) data obtained from enrolled CAP patients and isolated~     pathogens would be integrated analyzed and interpreted. Tthe investigators believe that an~     appropriate molecular typing method would lead to revolutionary changes in current~     arrangements of CAP.~   "
36167|NCT03093207|"~     The aim of this randomized controlled clinical trial of superiority will be to evaluate the~     effect of 3 g of omega-3 polyunsaturated fatty acids and 100 mg of aspirin daily~     supplementation over a period of 180 days as adjunct to surgical therapy of residual pockets~     from patients with generalized aggressive periodontitis. Probing depth, clinical attachment~     level, gingival index and concentration of microorganisms and cytokines at baseline, 3, and 6~     12 months after the procedure will be evaluated.~   "
36168|NCT03093194|"~     The investigators designed a randomized controlled trial to evaluate whether perioperative~     Vaginal preparation is superior to no Vaginal preparation in decreasing post CS endometritis.~     Since CS is performed in about 30% of all births and infection complicates 6-11% of all CS~     reducing the rate of this post CS complication can have a major impact not only on the~     hospital occupancy and costs but also on the new mother experience and ability to face the~     challenge that awaits for her with her newborn.~      In this study patients will be randomly assigned into two groups. The experiment group will~     not undergo any vaginal preparation. The control will undergo perioperative vaginal~     preparation with antiseptic soap followed by chlorohexidine-alcohol Both groups will be~     checked for cervical dilation with sterile gloves before surgery.~      Primary outcome - signs of endometritis (e.g. erythema around surgical scar, discharge or~     pain). Patients will be followed daily until discharge. A blood count will be drewn before~     discharge to rule out signs of infection. Patients will be contacted 6 weeks after surgery by~     telephone to inquire about any signs of infection, Emergency Room visits or ambulatory visits~     to the doctor due to endometritis. The participants will be asked if they had positive skin~     culture or other wound complications such as cellulitis, seroma or scar separation.~      The investigators estimated that 1040 patients will have to enroll into the study, 520 in~     each group in order to have 80% power to detect 50% difference in the endometritis rates~     between the two groups with a two tailed α level of 0.05.~      The data analysis was conducted according to the per-protocol principle.~   "
36169|NCT03093181|"~     This study is designed to evaluate the cosmetic benefit provided by twice daily application~     of a developmental moisturising cream with niacinamide for 8 weeks in healthy female~     participants with sensitive, oily, blemish-prone skin.~   "
36170|NCT03093168|"~     The goal of this clinical trial is to study the feasibility and efficacy of anti-B-Cell~     Maturation Antigen (BCMA) expressing T cells in treating patients with multiple myeloma.~   "
36171|NCT03093155|"~     This is a randomized, two-arm, open-label Phase II multicenter study designed to examine the~     effects of adding bevacizumab to ixabepilone for the treatment of patients who have recurrent~     or persistent platinum-resistant/refractory epithelial (non-mucinous) ovarian, fallopian~     tube, or primary peritoneal cancer. Its primary objective is to assess whether adding~     bevacizumab to ixabepilone improves progression-free survival in its target population. Study~     participants will be stratified by (a) study site and (b) previous receipt of bevacizumab~     prior to randomization.~   "
36172|NCT03093142|"~     This is a double blinded, randomized control trial with a pretest-posttest control and~     interventional groups design. Both the assessor and participants are blinded to all~     assessments and evaluations. All patients with subacute stroke undergo in-patient or~     out-patient rehabilitation are screened initially by a series of screening test. Suitable~     patients are assigned randomly to 3 groups respectively. Group 1 is the combined transcranial~     direct current stimulation (tDCS) and neurofeedback group. Group 2 is the neurofeedback~     group. Group 3 is the control group with sham neurofeedback training.~   "
36173|NCT03093129|"~     This is a Phase II randomized, double-blind, placebo-controlled trial of neoadjuvant~     artesunate given orally as a dose of 200 mg once a day for 14 days to patients with~     histologically confirmed Stage II/III colorectal cancer (CRC) awaiting surgical treatment~     with curative intent.~   "
36174|NCT03093116|"~     Phase 1 will assess safety and tolerability of TPX-0005 via a standard dose escalation~     scheme, and determine the recommended phase 2 dose.~      Phase 2 will assess safety and efficacy of TPX-0005.~   "
36247|NCT03092154|"~     The use of lipid lowering agents in patients with idiopathic inflammatory myopathies is~     controversial. Therefore, the aim of the present study is to assess clinically and laboratory~     the impact of lipid-lowering agents in this population.~   "
36248|NCT03092141|"~     Physical training may improve physical capacity and health parameters in various systemic~     autoimmune diseases. Therefore, the present study will assess the role of an exercise~     training program in patients with relapsing polychondritis.~   "
36175|NCT03093103|"~     SGLT-2 inhibitors belong to a new class of hypoglycemic drugs with the unique property of~     decreasing blood glucose through an increase in glucosuria. These drugs inhibit the sodium~     glucose transporter 2 (SGLT2) expressed at the luminal membrane of the proximal tubule.~      SGLT-2 inhibition in type 2 diabetic subjects and in healthy volunteers shifts the threshold~     for renal glucose excretion to lower levels. This effect is independent from insulin. The~     inhibition of SGLT2 decreases HbA1C, systolic blood pressure and weight in diabetic subjects.~     Recently, the EMPA-REG trial demonstrated a decrease in cardiovascular mortality and renal~     endpoints in empagliflozin treated type 2 diabetic patients with established cardio-vascular~     disease.~      Because this novel hypoglycemic drug has unique and direct effects on renal tissue~     metabolism, it is important to better examine its effects on the kidney. With this study, we~     propose to explore the effects of empagliflozin on renal tissue oxygenation. Our hypothesis~     is that SGLT-2 inhibition decreases renal cortical energy requirements with consequently an~     increase in renal tissue oxygenation.~   "
36176|NCT03093090|"~     Poorly absorbed medications such as furosemide are common and recent experiments suggest that~     improvement in absorption can occur if these types of medications are consumed with liquids~     such as milk. The purpose of this study is to evaluate the absorption of furosemide in normal~     adults when taken with bottled water, milk (Parmalat™ Whole Milk), baby formula (Similac~     Pro-Advance™), or Ensure Plus™. These results will be used to make models that predict how~     these liquids will affect drug absorption in children, potentially providing ways to improve~     medication absorption in children.~   "
36177|NCT03093077|"~     The purpose of this study is to evaluate and compare implant kinematics of conventional~     mechanically aligned and anatomically aligned total knee arthroplasties (TKA) at 1 year~     post-operatively.~   "
36178|NCT03093064|"~     Schizophrenia affects a significant proportion of the population and current levels of~     understanding of the illness is inadequate to treat it effectively. Converging lines of~     evidence suggest that neuroinflammation occurs in schizophrenia, and specifically~     over-activity of brain-resident immune cells called microglia. It is however unclear whether~     activated microglia play a primary role in schizophrenia, or whether this is a secondary~     phenomenon of no pathophysiological significance. The investigators therefore plan to test~     the effect of a monoclonal antibody (natalizumab) on psychotic symptoms in a cohort of first~     episode psychosis patients.~   "
36179|NCT03093051|"~     This observation study evaluates the safety and effectiveness of UPT therapy in subjects~     during either an indicated ventricular tachycardia ablation procedure or an ICD implant~     procedure.~   "
36180|NCT03093038|"~     The goal of this study is to study the stability of the Delta-TT cup with polyethylene insert~     and the Delta-TT cup with ceramic insert both combined with the H-MAX femoral stem by means~     of RSA to assess whether the differences in stiffness of the cup will have an influence on~     incorporation and mechanical stability.~      It is hypothesized that there will be more micromotion on the short-term (<2 years) in the~     patients with the ceramic insert because of the higher stiffness, however, all components~     will be considered stable on the short and long-term.~   "
36181|NCT03093025|"~     The purpose of this study is to evaluate the safety, tolerability, and efficacy of TS-121 as~     an adjunctive treatment for patients with major depressive disorder with an inadequate~     response to current antidepressant Treatment (SSRI, SNRI or bupropion).~   "
36182|NCT03093012|"~     This study will collect retrospective and prospective clinical data regarding the Principal~     Investigator's patient population to allow for data analysis seeking basic trends and to~     prepare academic reports, including journal manuscripts and presentations for scientific~     organizations.~   "
36183|NCT03092999|"~     Evaluate the potential effect of hepatic impairment on the pharmacokinetics, safety and~     tolerability of BAY1002670 (vilaprisan)~   "
36184|NCT03092986|"~     Lung cancer is the leading malignancy worldwide and in Bangladesh. Most of the lung cancer is~     of Non-small Cell Lung Cancer (NSCLC) type. For locally advanced NSCLC, combined modality~     treatment is required. Concurrent chemo-radiotherapy and sequential chemo-radiotherapy are~     the two recommended options. Sequential chemo-radiotherapy is mainly practiced in Bangladesh~     due to its less toxicity profile. There is no head to head comparative study done which~     focuses on the sequential chemotherapy regimens used in locally advanced NSCLC.~      Hypothesis:~      Null Hypothesis (H0): Sequential chemotherapy with cisplatin and vinblastine followed by~     radiotherapy and paclitaxel and carboplatin followed by the same radiotherapy in locally~     advanced NSCLC, there is no difference in loco-regional tumor control.~      Alternative Hypothesis (HA): Sequential chemotherapy with cisplatin and vinblastine followed~     by radiotherapy and paclitaxel and carboplatin followed by the same radiotherapy in locally~     advanced NSCLC, cisplatin and vinblastine is more responsive and effective in loco-regional~     tumor control than paclitaxel and carboplatin.~   "
36185|NCT03092973|"~     Epistaxis is a very frequent emergency among adults and often needs specialised treatment in~     an ENT-department. Among others, atherosclerosis is often named as a reason for an increased~     risk for Epistaxis. To evaluate whether or not this is the case, the investigators examined~     the carotid intima media thickness via ultrasound in patients who were treated in the~     ENT-department of the University Hospital of Zurich.~   "
36186|NCT03092960|"~     The purpose of this study is to test a flexible lifestyle program designed to help Latino men~     make healthy lifestyle changes to lower their risk of developing diabetes and heart disease.~     The program is called HOMBRE (Hombres con Opciones para Mejorar el Bienestar y bajar el~     Riesgo de Enfermedades crónicas; English translation: Men with choices to improve well being~     and decrease chronic disease risk).~   "
36187|NCT03092947|"~     Although acute kidney injury (AKI) frequently complicates cardiac surgery, methods to~     determine AKI risk are lacking. Renal functional reserve (RFR), the capacity of the intact~     nephron mass to increase glomerular filtration rate (GFR), represents maximal filtration~     capacity. We hypothesized that preoperative RFR would predict postoperative AKI.~   "
36188|NCT03092934|"~     This two-part study consists of a Phase 1 dose escalation study in participants with locally~     advanced or metastatic solid tumors, and a Phase 2 portion in up to 3 cohorts with either~     Small Cell Lung Cancer, Breast Cancer and/or one other solid tumor type~   "
36189|NCT03092921|"~     This investigation is designed to evaluate the performance as well as the patients overall~     acceptance of the seal/mask.~   "
36190|NCT03092908|"~     Kidney stones are one of the most common disorders of the urinary tract and cause a great~     deal of morbidity and economic loss. Because of the high recurrence rate, researchers are~     interested in finding medicinal therapies to prevent kidney stone recurrence. Vinegar is~     consumed worldwide as a food condiment and preservative. The mature vinegar, also called~     black vinegar, is an inky-black vinegar aged for a malty, woody, and smoky flavor. It is~     popular in the north of China as a dipping sauce, particularly for dumplings.~      Some studies promote vinegar for its medicinal properties, as a tonic which may lower blood~     pressure and cholesterol level. Our national epidemiological data in China showed that~     consumed more mature vinegar was associated with decreased risk of kidney stones formations.~     Furthermore, our previous in vivo study found that mature vinegar could inhibit renal calcium~     oxalate crystals formation in rat model. These findings inspire us to clarify the~     nephrolithiasis prevention effect of mature vinegar in a clinical trial. In this study,~     investigators would like to examine the efficacy of mature vinegar prophylaxis for preventing~     recurrent calcium oxalate nephrolithiasis.~   "
36191|NCT03092895|"~     This an open-label，Non-Randominzed Phase 2 study to evaluate the Safety and Tolerability of~     SHR-1210 in combination with Apatinib or FOLFOX4 regimen in subjects with Advanced PLC.~      Participants with advanced PLC who failed or intolerable to prior systemic therapy will be~     treated with SHR-1210 plus Apatinib; Participants with advanced PLC who have never received~     prior systemic therapy will be treated with SHR-1210 plus FOLFOX4 regimen.~   "
36192|NCT03092882|"~     The Digital Self-Management Program for Medicare Advantage Members with Type 2 Diabetes -~     Impact on A1c trial is a 26-week long, prospective, intent-to-treat, 2-arm randomized~     controlled trial that aims to evaluate the impact of the Digital Self-Management Program on~     A1c levels for individuals with uncontrolled Type 2 diabetes.~   "
36193|NCT03092869|"~     This study aims to assess whether mobilization of the ankle and foot produces significant~     improvements in the balance of the elderly.~      To this end, a randomized study was designed with a control group that performs~     proprioception exercises and an experimental group that also performs a mobilization of the~     ankle and foot joints.~   "
36194|NCT03092856|"~     This randomized phase II trial studies how well axitinib with or without anti-OX40 antibody~     PF-04518600 work in treating patients with kidney cancer that has spread to other parts of~     the body. Biological therapies, such as anti-OX40 antibody PF-04518600, use substances made~     from living organisms that may may stimulate the immune system in different ways and stop~     tumor cells from growing. Axitinib may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Giving axitinib with or without anti-OX40 antibody~     PF-04518600 may work better in treating patients with kidney cancer.~   "
36195|NCT03092843|"~     Investigators aim to assess changes in exercise capacity and quality of life after septal~     myectomy in patient with hypertrophic cardiomyopathy.~   "
36196|NCT03092830|"~     The objective is to find genes which are responsible for the appearance of skin tumors (sCC,~     BCC) and it will be the basis for prediction of the disease and response to the treatment~   "
36197|NCT03092817|"~     The investigators will conduct a randomized, double blind, placebo controlled trial of~     adjunctive dexamethasone in the initial (6-8 weeks) treatment of tuberculous meningitis in~     Vietnamese adults. The trial will address a primary hypothesis in all enrolled patients, and~     a secondary hypothesis in a sub-group of enrolled patients who develop anti-tuberculosis~     drug-induced liver injury (DILI). The primary hypothesis is adjunctive dexamethasone~     increases survival from TBM in HIV co-infected adults. The secondary hypothesis is current~     guidelines for the management of anti-tuberculosis drug-induced liver injury in those with~     TBM result in the premature interruption of rifampicin and isoniazid (the critical active~     drugs in early therapy) and are thereby placing participants at risk of poor outcomes.~   "
36198|NCT03092804|"~     With the advent of the aging society, dementia becomes the focus of common people. As for the~     neurodegeneration dementia, no disease modifying treatments have been discovered. Idiopathic~     normal pressure hydrocephalus (iNPH) is considered as one of reversible dementia, which can~     be hint by the surgery. In addition, dementia of iNPH is the typical subcortical dementia.~     Therefore exploring the pathogenic mechanism is conducive to the early diagnosis and~     treatment. This research is to monitor the changing of iNPHGS, cognitive function, walking~     ability as well as brain construction imaging and neural network before and after~     ventriculo-peritoneal shunting in order to demonstrate the pathogenesis of triads. In the~     process, the supplementary test, for instance, CSF tap test, will be validated the predictive~     value.~   "
36199|NCT03092791|"~     The purpose of this study is to select the optimal antigen content of the three Sabin~     poliovirus strains (types 1, 2, and 3) entering the composition of the stand-alone trivalent~     Sabin-based inactivated poliomyelitis vaccine (sIPV) to take forward into advanced stage~     studies. The selection will be carried out comparing the three sIPV study arms based on the~     safety and tolerability profile after each dose of primary immunization and the immune~     response to poliovirus types 1, 2, and 3 for both Sabin and Salk strains, after the final~     dose of a three dose primary immunization series (Day 85).~   "
36200|NCT03092778|"~     The purpose of this study is to assess the efficacy of cryoablation therapy for the treatment~     of mild to moderate obesity and test the safety (good and bad effects) of this procedure. The~     vagus nerve transmits hunger signals from the stomach to the brain, and in response transmits~     stomach expansion signals from the brain to the stomach. Investigators believe that by~     interrupting this communication, participants could experience less hunger and in turn lose~     weight.~   "
36201|NCT03092765|"~     This study is a placebo-controlled, randomized, double-blind, multicenter, parallel-group~     comparison study in primary biliary cholangitis participants inadequately responding to~     ursodeoxycholic acid.~   "
36202|NCT03092752|"~     Appropriate use of oral antidiabetic drugs (OADs) including dose-reduction is important for~     patient's safety in T2DM patients with renal impairment (RI). However, there are insufficient~     data on dose adjustment in accordance with the prescription pattern and the risk of RI of~     OADs, in particular DPP-4 inhibitors, in clinical practice in Japan. Therefore, we will~     investigate OADs usage conditions and dose selection in T2DM patients with RI in clinical~     practice in Japan~   "
36268|NCT03091881|"~     Diabetic Parturients are exposed to intraoperative hypotension after spinal anesthesia and we~     proposed that intravenous Granisterone 1 mg will attenuate the hypotension occurred with~     spinal block during Cesarean sections.~   "
36205|NCT03092713|"~     A considerable number of patients with mild and moderate traumatic brain injury (TBI)~     experience long-lasting somatic, cognitive, and emotional symptoms that may hamper their~     capacity to return to work (RTW). Although several studies have described medical,~     psychological and work-related factors that predict RTW after TBI, well-controlled~     intervention studies regarding RTW in this group are scarce. Furthermore, there have~     traditionally been weak collaborations among rehabilitation services in the health sector,~     the Labor and Welfare Administration (NAV), and the work-places.~      The current project proposal describes an innovative randomized controlled trial (RCT) which~     will explore the effect of combined manualized cognitive rehabilitation efforts and supported~     employment in real-life competitive work settings for patients who have not returned to work~     8 weeks post-injury. The project combines the rehabilitation and vocational science~     perspectives; it involves multidisciplinary collaboration, and explores the efficacy of~     increased cross-sectorial collaboration between specialized health care services and the~     welfare system. If the intervention proves efficient, the project will further describe the~     cost-effectiveness and utility of the program, and thereby provide important information of~     use for policy makers. In addition, the study aims at generating knowledge on the RTW-process~     both for the persons with TBI, and their workplaces, and to disseminate this knowledge in~     order to create new multidisciplinary and collaborative practices. The project has potential~     to generate knowledge of relevance for other patients with neurological deficit.~   "
36206|NCT03092700|"~     To evaluate whether pulmonary rehabilitation improves emotional cognition, using facial~     emotions recognition and smile production, by improving the emotional dimension of dyspnoea~     in patients with chronic obstructive pulmonary disease (COPD).To evaluate whether pulmonary~     rehabilitation improves emotional cognition, using facial emotions recognition and smile~     production, by improving the emotional dimension of dyspnoea in patients with chronic~     obstructive pulmonary disease (COPD).~   "
36207|NCT03092687|"~     Background:~      The Human Brain Collection Core (HBCC) collects brain and other tissues. They get these from~     deceased people who may or may not have had psychiatric disorders. The next of kin gives~     permission for researchers to get the tissues. Researchers want to collect medical details of~     people whose brains are donated. They also want to use the donated tissue to study brain~     chemistry and structure. This could lead to better treatments for mental illness.~      Objective:~      To create a collection of human brain tissue to learn about the causes and mechanisms of~     mental disorders.~      Eligibility:~      People willing to donate their deceased relative s brain tissue. The deceased person could~     not have had any of the following:~      Severe mental retardation~      Long-lasting seizure disorder~      Infections that affect the brain~      Decomposition~      Brain damage~      Being on a respirator for more than 12 hours~      Major sepsis~      Serious renal or hepatic disease~      Certain dementias and degenerative diseases~      Design:~      Medical Examiner s Offices will screen donors who have recently died. Some others will be~     screened by hospitals or funeral homes.~      Participants will be the next of kin. They will give consent for HBCC to obtain brain tissue~     from the deceased person. The tissue will be frozen for future research.~      Participants will have a 30-minute phone call. They will answer questions about the deceased~     person s medical and psychiatric conditions. They will answer questions about the person s~     use of medicines and drugs.~      Participants will be contacted by a social worker. They will be asked for permission to~     access the deceased person s medical records.~   "
36208|NCT03092674|"~     This randomized phase II/III trial studies how well azacitidine with or without nivolumab or~     midostaurin, or decitabine and cytarabine alone work in treating older patients with newly~     diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome. Drugs used in~     chemotherapy, such as azacitidine, decitabine, and cytarabine, work in different ways to stop~     the growth of cancer cells, either by killing the cells, by stopping them from dividing, or~     by stopping them from spreading. Monoclonal antibodies, such as nivolumab, may interfere with~     the ability of cancer cells to grow and spread. Midostaurin may stop the growth of cancer~     cells by blocking some of the enzymes needed for cell growth. Giving azacitidine with or~     without nivolumab or midostaurin, or decitabine and cytarabine alone may kill more cancer~     cells.~   "
36209|NCT03092661|"~     To define preliminary reference (normative) limits for healthy, newborn baby oxygen~     saturation parameters using the Masimo Radical 7® monitor.~      To assess protocol feasibility in terms of acceptability to parents and infants.~      To inform the design of a future larger study where reference limits will be fully defined~     across a wider gestational age group.~   "
36210|NCT03092648|"~     Chronic Obstructive Pulmonary Disease (COPD) is a kind of chronic bronchitis or emphysema~     with characteristics of long-term poor airflow, resulting in chronic pulmonary heart disease,~     chronic respiratory failure or even death. Anatomically, the pulmonary bronchus structures in~     COPD patients are damaged and cannot be repaired by recent clinical treatment so far. This~     study intends to carry out an open, single-armed, phase I/II clinical trial to investigate~     whether bronchial basal cells can regenerate damaged lung tissue. During the treatment,~     bronchial basal cells will be isolated from patients' own bronchi and expanded in vitro.~     After careful characterization, cultured cells will be transplanted autologously into the~     lesion by fiberoptic bronchoscopy. The safety and efficacy of the treatment will be monitored~     by measuring the key clinical indicators.~   "
36211|NCT03092635|"~     The purpose of this study is to look at the effects that the study drugs (metformin and OPC)~     have on AGE levels in patients with ER+ metastatic breast cancer.~   "
36212|NCT03092622|"~     Patients with severe Chronic Obstructive Pulmonary Disease (COPD) and low oxygen levels in~     the blood are at risk of developing pulmonary hypertension and strain on the right side of~     the heart, both of which are known to increase symptoms and worsen prognosis It is not fully~     established whether interval exercise training in patients with severe COPD and concomitant~     low oxygen levels is beneficial.~      This study aims to evaluate the effects of aerobic interval exercise training in patients~     with severe COPD and low oxygen levels in the blood, with a particular emphasis on such~     effects on the cardiovascular system and pulmonary circulation.~   "
36321|NCT03091192|"~     This study is designed for patients diagnosed with MET-driven, unresectable and locally~     advanced or metastatic Papillary Renal Cell Carcinoma. The purpose of this study is to see if~     an investigational new anti-cancer medication, savolitinib, is effective in treating patients~     with MET-driven PRCC, how it compares with another medication frequently used to treat this~     disease called sunitinib, and what side effects it might cause.~   "
36213|NCT03092609|"~     Anxiety disorders are one of the most common psychological disorders. Underlying anxiety is~     an increased attentional bias to threat, which has been identified as a causal contributor in~     the development of anxiety. Given this causal relationship, attention bias modification was~     introduced as a treatment option where anxiety is reduced by training individuals to direct~     their attention away from threat and thereby decreasing anxiety. Over a decade of research~     using this approach, called attention bias modification (ABM), suggests that overall the~     approach is effective in reducing anxiety. Although ABM appears to be a very promising~     treatment option for anxiety, there are several factors limiting the effectiveness of ABM.~     These include the recognition of individual-level needs and a known underlying mechanism of~     action by which ABM is effective. Neuroimaging evidence suggests that attentional bias to~     visual threat is associated with a network of brain regions including the amygdala, anterior~     cingulate cortex, and visual cortex. In human participants, experience-dependent~     neuroplasticity is visible in voxel-based morphometry based measures of gray matter volume~     following training. Recently, voxel-based morphometry measures of gray matter volume have~     been linked to dendritic spine density—a known cellular mechanism for learning-related~     neuroplasticity. Thus, voxel-based morphometry measures are ideally suited to measure~     learning-related neuroplasticity following attention bias modification. In this proposal~     participants' level of attentional bias, anxiety, and gray matter volume will be measured~     before and after completing six weeks of attention bias modification training (N = 50) or~     attention control training (N= 50). The proposal aims to (1) establish that pre-treatment~     bias predicts variability in gray matter volume in the extended amygdala and anterior~     cingulate cortex, (2) assess the extent to which reduced extended amygdala and anterior~     cingulate cortex gray matter volume following ABM underlies reductions in attentional bias~     and anxiety, and (3) Establish pre-treatment bias as a predictor of successful ABM as~     measured by reduced bias, reduced anxiety, and reduced gray matter volume in the extended~     amygdala and anterior cingulate cortex. Consistent with the objectives of the AREA grant and~     NIMH's focus on identifying and validating new targets for treatment development that~     underlie disease mechanisms, the current proposal plans to involve students at a rural~     primarily undergraduate university in a research project aimed at establishing~     neuroplasticity in the extended amygdala and anterior cingulate cortex as a target mechanism~     for ABM training outcome, which could be used to objectively track training-related outcomes~     in anxiety treatment.~   "
36214|NCT03092596|"~     Substance abuse and dependence is highly prevalent among people living with HIV and~     significantly exacerbates morbidity and mortality and accelerates HIV disease progression.~     Antiretroviral therapy (ART) has been the single most important treatment for slowing disease~     progression. ART adherence and HIV primary care are affected by a complex array of factors in~     the context of lives impacted by socioeconomic, psychological, and health challenges. Drugs~     and alcohol play a major role in non-adherence, engagement in care, and poor health outcomes~     among HIV-infected persons. While evidence is unequivocal that substance use treatment~     improves health outcomes, systems of care for the detection and treatment of substance abuse~     and dependence remain fragmented. Integrated approaches are key to the delivery of optimal~     care. Pragmatic or effectiveness trials can provide the best evidence about clinical practice~     to inform practitioners and policy makes about the most clinically and cost effective~     treatment to inform dissemination on a wider scale at the organizational and public health~     levels. The goal of this trial is to develop and test a comprehensive, integrated program to~     detect and reduce substance abuse and in turn, to improve ART adherence and HIV, substance~     use and associated health outcomes among HIV-infected patients. This trial will test the~     effectiveness of the intervention using a stepped wedge trial design to sequentially~     implement a screening tool and training of patient health navigators at HIV clinics in NYC.~   "
36215|NCT03092583|"~     The aim of this project is to quantify global DNA methylation in patients with Ankylosing~     Spondylitis or Axial Spondyloarthritis as compared with control subjects.~   "
36216|NCT03092570|"~     This study will assess the putative advantages of cerebellar stimulation on motor learning~     abilities of stroke patients. In order to have a control group to refer to, the effect of~     cerebellar stimulation on healthy young and old participants will also be assessed.~   "
36217|NCT03092557|"~     This study is designed to assess the feasibility of the measurement of local pleural strain~     at 4 different anatomical sites.~      The secondary objectives of the study are:~        -  To assess intra- and inter-observer variability in the measurement of local pleural~          strain~        -  To identify the strain parameters demonstrating the most clinically relevant and the~          most significant correlation with a change in tidal volume~      Hypothesis: The analysis of lung ultrasonographic sequences using speckle-tracking allows the~     determination of local pleural strain in 4 predetermined pulmonary areas.~   "
36218|NCT03092544|"~     The purposes of this study is to identify types of bacteria that reside in the intestine of~     healthy individuals and compare them to individuals with Multiple Sclerosis (MS). There has~     been a lot of research in other autoimmune diseases which has demonstrated the importance of~     stomach gut bacteria because it has an important relationship with the immune system, but~     this has never been studied in MS patients. In this study investigators aim to show~     differences in the gut bacteria between healthy individuals and those with MS, to provide a~     basis for future research studying how diet can affect MS through its effects on the gut~     bacteria.~      Additionally, this study will be looking at the effects of dimethyl fumarate on cerebrospinal~     fluid, plasma and MRI in MS patients taking dimethyl fumarate as compared to those with MS~     not on dimethyl fumarate or other disease modifying therapy and those who do not have MS~     (normal controls).~   "
36219|NCT03092531|"~     This randomized control trial is to test the efficacy of a stepped-care adaptive~     Antiretroviral Therapy (ART) adherence intervention (Positive STEPS) for HIV infected~     adolescents and young adults, ages 16 to 24. Stepped care is a healthcare delivery model in~     which the least resource intensive part of an intervention is delivered first, and only those~     who do not improve then receive the high intensity, more resource intensive part of an~     intervention.~   "
36220|NCT03092518|"~     Background:~      Gastric cancer is a common and serious cancer. Standard treatment is chemotherapy drugs.~     Researchers want to see if a new treatment helps. It is surgical removal of the cancer and~     heated chemotherapy delivered to the abdominal cavity called HIPEC.~      Objective:~      To test if surgical removal of tumors plus heated intraperitoneal chemotherapy can improve~     survival in people with gastric cancers.~      Eligibility:~      People ages 18 and older with gastric cancer who can have most tumors surgically removed~      Design:~      Participants will be screened with:~        -  Medical history~        -  Physical exam~        -  Blood, urine, and heart tests~        -  Scans~        -  Tissue sample from previous surgery~        -  Endoscopy with biopsy: A tube with a camera goes through the mouth and into the stomach.~          It and takes a sample of stomach tissue. Participants might may get medicine to make~          them drowsy.~        -  Laparoscopy: Small cuts are made in the abdomen. A thin tube with a light and camera is~          inserted into the abdomen. Participants sleep through the procedure.~      Participants will stay in the hospital. They will have:~        -  Surgery to remove as many tumors as possible.~        -  HIPEC for 60 minutes: Two thin tubes are put into the abdomen. Two chemotherapy drugs~          are given through one tube. They are drained out through another at a temperature a few~          degrees above normal body temperature. Another drug is given in a vein.~      Recovery for 7-21 days: Participants will have tubes in their stomach and bladder and IVs for~     a few days. They will get pain medicine, IV fluids, antibiotics, and blood transfusions as~     needed.~      Participants will have visits every few months for 3 years, then one a year. Visits include~     physical exam, blood tests, and scans. They also include dietary assessment and questions.~   "
36262|NCT03091959|"~     The study looks to evaluate the device diagnostic data obtained from (all the Cardiac Rhythm~     and Heart Failure (CRHF) devices of medtronic having the Cardiac Compass® and OptiVol®~     diagnostic feature) these devices to identify trends during clinical events that will help~     early detection and prevention of cardiovascular and other comorbid conditions. (i.e. Heart~     failure(HF), Atrial Fibrilation,COPD, Renal dysfunction (RD), Diabetes etc.)~   "
36221|NCT03092505|"~     Background:~      Herpes virus can cause sores on the body. It can cause flu-like symptoms like fever and~     muscle aches, and even a type of cancer. Many people with HIV also have infections with~     herpes virus. When these people start taking HIV medicines, their herpes virus symptoms can~     suddenly start or become worse. Researchers want to find out more about how often this~     happens and why.~      Objective:~      To study the effects of HIV treatment in women who may have herpes virus infections.~      Eligibility:~      Women age 18 years and older who have been diagnosed with HIV infection.~      Design:~      Participants will be screened with a physical exam, medical history, and blood and urine~     tests.~      Participants will have about 8 study visits. Each will take about 1-2 hours.~      Participants will return to the clinic 1-2 weeks after the screening visit to receive their~     antiretroviral (ART) medicine. They will get instructions for taking it.~      Participants will have 6 more study visits over 1 year.~      During study visits, participants will have blood and urine tests, vaginal fluid collected,~     and an oral swab. They may have an external genital exam. They will get their next supply of~     ART medicine.~      Some participants may have a chest x-ray.~      Participants may have leukapheresis. Blood will be removed through a needle in an arm. It~     will be run through a machine that separates out the white blood cells. The rest of the blood~     will be returned through a needle in the other arm.~      The total time participants will be in the study is about 1 year.~   "
36222|NCT03092492|"~     Objective:~      To learn more about AMD.~      Eligibility:~      People ages 55 and older with any of the following:~      AMD or changes in the retina that put them at risk for AMD~      RPD~      Healthy eyes~      Design:~      Participants will be screened with:~      Eye exam: The pupil will be dilated with eye drops. Eye pressure and movements will be~     checked. Pictures will be taken of the inside of the eye.~      Reading an eye chart.~      Optical coherence tomography (OCT): The eyes are dilated. A machine measures the thickness of~     the retina.~      Participants will have a first visit that includes:~      Repeat of screening procedures~      Medical history~      Physical exam~      Questions about vision and general health~      Dark adapted fundus perimetry: Participants sit in the dark for 40 minutes. Then they sit at~     a machine that shines lights in the eyes.~      Dark adaption testing: Participants sit in the dark for 45 minutes. The pupils are dilated.~     They push a button when they see light in a machine for up to 1 hour.~      Participants will have annual visits for up to 5 years to repeat the tests in the first~     visit. Participant data may be shared for other research.~   "
36223|NCT03092479|"~     Prospective, randomized pilot trial to evaluate a comprehensive postoperative behavioral~     support intervention using a 4-month bi-weekly program in 40 bariatric surgery patients (all~     surgical procedure types) from the Geisinger Health System Center for Nutrition and Weight~     Management compared to 40 usual care patients.~   "
36224|NCT03092466|"~     Assess if the addition of an early femoral nerve block (performed within 2 hours from the~     admission in emergency department through a femoral nerve catheter) in the elderly patients~     (> 70 years) with hip fracture, reduces the incidence of postoperative delirium assessed by~     CAM 3Ds test, compared to the traditional systemic pain therapy.~   "
36225|NCT03092453|"~     The purpose of this study is to investigate a method of using dendritic cells (a kind of~     white blood cell) as a vaccine to stimulate your own immune system to react to your melanoma~     cells.~   "
36226|NCT03092440|"~     The use of simulation in medical education has been associated with positive results in the~     acquisition of knowledge, skills, behaviors and patient outcome. Serious games are useful~     educational tools since they allow both theory and practice training for an important number~     of learners, simultaneously. However, few studies have evaluated the validity and~     effectiveness of serious games.~      Our simulation unit (LabForSIMS- Faculté de Médecine Paris-Sud, France) has developed a~     serious game named LabForGames Warning for nursing students with the following learning~     objectives: to recognize and to address the degradation of a patient's clinical condition and~     to work on the issue of inter-professional communication. The aim of the present study is to~     determine content and construct validities of the LabForGames Warning serious game before~     its use as a healthcare professional training tool.~   "
36227|NCT03092427|"~     This study investigates the efficacy of probiotic VSL#3 as an add on standard care on the~     activity of the disease in patients with Juvenile Idiopathic Arthritis.~   "
36228|NCT03092414|"~     The newly developed linked color imaging (LCI) system (FUJIFILM Co.) creates clear and bright~     endoscopic images by using short-wavelength narrow-band laser light combined with white laser~     light on the basis of BLI technology. This system can obtain bright endoscopic images even at~     a distant view because LCI has more intense white light than the short-wavelength narrow-band~     laser light. Short-wavelength narrow-band laser light enhances the vessels on the mucosal~     surface and the patterns of the mucosa. Therefore, LCI may facilitate the detection of~     gastric mucosal lesions. Further studies are needed to confirm the clinical utility of LCI.~   "
36229|NCT03092401|"~     Hepatopulmonary Syndrome is a respiratory complication of liver cirrhosis defined as a triad:~     hypoxemia (PaO2 < 80 mmHg in room air), chronic liver disease and intrapulmonary~     vasodilatations. Its prevalence varies between 4 and 32%. Numerous treatments have been tried~     but the only efficient therapy to cure the syndrome is liver transplantation. Without~     transplantation it is associated with a higher mortality which is the reason why~     hepatopulmonary syndrome patients have a higher priority to transplantation. However it~     appears in some restricted studies that hepatopulmonary syndrome is associated with more~     postoperative complications (infections, vascular and biliary complications, prolonged length~     of mechanical ventilation…).~      The investigators hypothesised that hepatopulmonary syndrome patients have more postoperative~     complications after liver transplantation than non hepatopulmonary syndrome patients matched~     on age, MELD (Model for End-Stage Liver Disease) score, comorbidities, perioperative~     transfusion and noradrenaline doses.~   "
36230|NCT03092388|"~     This study aims to investigate the influence of a potential leg fluid shift (LFS) in patients~     with chronic heart failure (CHF) and obstructive sleep apnea (OSA) or central sleep apnea~     (CSA).~   "
36231|NCT03092375|"~     The study will enroll well-compensated cirrhotic as well as non-cirrhotic subjects treatment~     experienced with an NS5a Inhibitor + sofosbuvir and will include patients who did not~     complete the prescribed duration due to adverse event or any reason other than for non/poor~     compliance. Subjects will be randomized to 12 or 16 weeks of treatment.~   "
36232|NCT03092362|"~     Heart rate variability (HRV) in patients with atrial fibrillation (AF) is hardly studied.~     Though a reduced HRV in patients with heart failure and reduced ejection fraction (HFrEF) has~     been associated with poor prognosis. Data on HRV in AF-patients without a reduced ejection~     fraction is lacking. We hypothesize that those patients with persistent atrial fibrillation~     and larger beat-to-beat variability would be more symptomatic than does those with smaller~     HRV. To asses this theory we intend to perform a prospective observational trial. Symptoms of~     Atrial fibrillation will be assessed using Quality of Life questionnaires and 6 minutes~     walking test. Heart rate variability will be assessed using 24 hour Holter ECG monitoring.~      The correlation between symptoms and heart rate variability will be then assessed.~   "
36233|NCT03092349|"~     The primary aim of the present study is to investigate whether the optimisation of LVSV in~     addition to the optimisation of AV-D and VV-D when using the device-based sensor technology~     mentioned above results in an improved clinical outcome of CRT. Moreover, noninvasive~     measurements are intended to evaluate hemodynamic differences between the different~     stimulation configurations using the Finapres® method.~   "
36234|NCT03092336|"~     Introduction: the peripheral obstructive arterial disease is an condition that affects around~     15% of the world population interfering in muscle strength, life quality and functional~     capacity of patients.~   "
36235|NCT03092323|"~     This is an open-label, multi-institutional phase II randomized study comparing neoadjuvant~     radiotherapy followed by surgical resection to neoadjuvant pembrolizumab with concurrent~     radiotherapy, followed by surgical resection and adjuvant pembrolizumab. The total duration~     of pembrolizumab will be one year in the experimental arm.~   "
36236|NCT03092310|"~     The purpose of this pilot study is to establish that closed-loop insulin delivery with a~     target enchanted model predictive control (eMPC)/Health Monitoring System (HMS) algorithms~     with a trust index of the predicted glucose value is safe and effective, to analyze and learn~     to improve upon the accuracy of the predicted glucose values, and to collect efficacy data to~     inform a future larger study.~   "
36237|NCT03092297|"~     The purpose of this study is whether the mitochondrial oxygenation tension (mitoPO2) is a~     feasible and reliable tool in ICU patients with anaemia undergoing red cell transfusion to~     ultimately personalize blood transfusion decisions in the ICU.~   "
36238|NCT03092284|"~     The present aim is to perform at clinical double-blind placebo-controlled Cardiology Stem~     Cell Centre - Adipose Stem Cells (CSCC_ASC) study in heart failure patients to investigate~     the regenerative capacity of the CSCC_ASC treatment.~   "
36239|NCT03092271|"~     This randomized controlled trial will evaluate two approaches to achieving the aspirational~     goal of Zero Suicide within a health system: 1) Zero Suicide Best Practices initiated through~     a zero suicide quality improvement initiative within a health system; and 2) Zero Suicide~     Best Practices plus an innovative stepped care for suicide prevention intervention for~     adolescents and young adults that matches treatment intensity with risk levels for~     suicide/self-harm. ..~   "
36240|NCT03092258|"~     Conduct a questionnaire survey of palliative care professionals including doctors, nurses and~     social workers currently working within the West Midlands to establish how much the~     palliative care community in the West Midlands engage in preparing patients for their digital~     legacy and find out if there is a further education need in this community about digital~     legacy.~   "
36241|NCT03092245|"~     Efficacy and safety of OctaplasLG® administration vs. crystalloids (standard) in patients~     with septic shock - a randomized, controlled, open-label investigator-initiated pilot trial~   "
36242|NCT03092232|"~     The current study is the first clinical trial proposed with PF-06865571. It is designed to~     evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of~     single doses of PF-06865571 to healthy adult subjects.~   "
36243|NCT03092206|"~     Investigation of possible changes in insulin sensitivity in healthy volunteers taking the~     following HIV treatment combinations: F/TAF (group 1) as compared to E/C/F/TAF (group 2) as~     compared to R/F/TAF (group 3). The measurement of insulin sensitivity will be performed in 30~     HIV-negative healthy non-obese (BMI 18-25) male volunteers before and after 14±2 days of~     treatment. The volunteers will be randomly assigned to one of the three groups. Changes in~     insulin sensitivity will be measured by golden standard hyperinsulinemic euglycemic clamp~     (HEGC) technique, using glucose and insulin infusion as diagnostic agents~   "
36244|NCT03092193|"~     The family of cytochrome P450 (CYP) is the most important drug metabolizing enzymes which~     contributes to the metabolism of a large proportion of drugs in humans. Some CYP450 enzymes~     reduce or alter the pharmacodynamic activity of many drugs and are involved in oxidative~     metabolism and elimination of many drugs commonly used by the population. Polymorphisms in~     CYP2C8 and CYP2C9 are common in different populations around the world and genetic variations~     in these alleles can cause decreased enzyme activity to nonsteroidal anti-inflammatory drugs~     (NSAIDs) such as celecoxib, diclofenac, ibuprofen, indomethacin, lornoxicam, meloxicam,~     valdecoxib, piroxicam, tenoxicam and naproxen. This compromise the bioavailability of the~     drug can alter the pharmacokinetics of these drugs and patients with mutations in these genes~     can exhibit increased plasma concentrations of values and areas under the curve (AUC), in~     addition to decreased clearance of drugs. Associations between NSAIDs and gastric protectors~     or proton pump inhibitors (PPIs) have become common nowadays, especially in patients who make~     chronic use of these drugs. Naproxen associated to esomeprazole, a proton pump inhibitor~     (PPI), was launched in the market recently and its application in acute pain is not yet~     elucidated. Esomeprazole suffers strong influence of CYP2C19 (hepatic drug-metabolizing~     enzyme that degrades PPIs). In patients with high enzyme activity of the CYP2C19, the drug~     can suffer high enzymatic degradation, and its diminished effect. Moreover, in patients with~     low enzyme CYP2C19 activity, the effect of acid inhibition by PPIs can be very strong.~   "
36245|NCT03092180|"~     As a T2T, our patients with idiopathic inflammatory myopathies will receive pulse therapies~     with methyprednisolone and/or human intravenous immunoglobulin, or only methyprednisolone at~     disease onset.~      This scheme is an internal routine protocol of our Service.~   "
36246|NCT03092167|"~     Physical training may improve physical capacity and health parameters in various systemic~     autoimmune diseases, including idiopathic inflammatory myopathies. Therefore, the present~     study will assess the role of an exercise training program in patients with idiopathic~     inflammatory myopathies.~   "
36249|NCT03092128|"~     For patients of GIST (Gastrointestinal Stromal Tumor), Imatinib has been widely used in GIST~     with KIT or PDGFRA sensitive mutations. From clinical points of view, individual differences~     often occur between different patients, leading diverse effect in ADR and drug effect.~     Meanwhile, the drug effect and adverse drug reaction was significantly influenced by the~     pharmacokinetic factors and pharmacodynamic and other factors. In this research, we try to~     establish a more sensitive method to detect sensitive mutations in plasma and discover the~     correlation between somatic and germline mutations, plasma trough concentration and drug~     effect, the association between ADME-associated SNP, Target/Receptor/Pathway-associated SNP,~     trough concentration and TKI adverse effect. Furthermore, in vivo and in vitro research is~     also crucial for rational explanation for these clinical phenomenon.~   "
36250|NCT03092115|"~     This study will help determine feasibility, acceptability, and preliminary efficacy of an app~     for HIV medication adherence over a 3-month period. Participation is 3 months consisting of~     two study visits: An initial study visit and a 3 month follow up visit with both visits~     lasting about 60-90 minutes. The participant must use the study application (app) at least~     once daily, and at study visits, must complete surveys.~   "
36251|NCT03092102|"~     The Safety, Tolerability and Pharmacokinetic Study of idiopathic pulmonary fibrosis treatment~     drug HEC585 in Healthy Male and Female Subjects~   "
36252|NCT03092089|"~     This study evaluates what effect sonothrombolysis may have on spontaneous reperfusion,~     microvascular obstruction, left ventricular function and infarct size in patients presenting~     with their first ST-segment Elevation Myocardial Infarction.~   "
36253|NCT03092076|"~     This study is a open and single center clinical trial in healthy Chinese.The objective of the~     study is to clarify the pharmacokinetics characteristics and antiplatelet effects of~     ticagrelor in Chinese and to investigate the impact of genotype.~   "
36254|NCT03092063|"~     The overall objective of this study is to construct an adaptive intervention that integrates~     family members and patients as partners in care while promoting diabetes self-management for~     Mexican Americans with Type 2 diabetes. The project incorporates four evidence-based,~     culturally tailored treatments using a Sequential, Multiple Assignment Randomized Trial to~     help determine what sequence of intervention strategies work most efficiently and for whom.~   "
36255|NCT03092050|"~     Depression in family caregivers of relatives with Alzheimer's Disorder and related dementias~     is a serious public health problem. This is a randomized, controlled, single-blind pilot~     clinical trial of 50 depressed caregivers, to determine the efficacy and mechanisms of group~     therapy for depressed dementia caregivers.~   "
36256|NCT03092037|"~     The proposed study will investigate the relationship between genetic variants and serum~     contraceptive hormone levels, specifically the progestin etonogestrel. This study will~     provide the foundation for future pharmacogenomic investigations of more commonly used~     contraceptive methods with higher failure rates.~   "
36257|NCT03092024|"~     The Scleroderma Patient-centered Intervention Network (SPIN) is an organization established~     by researchers, health care providers, and people living with scleroderma from Canada, the~     USA, and Europe. The objectives of SPIN are (1) to assemble a large cohort of scleroderma~     patients to complete outcome assessments regularly in order to learn more about important~     problems faced by people living with scleroderma and (2) to develop and test a series of~     internet-based interventions to help patients manage aspects of scleroderma, including hand~     limitations.~      In the SPIN-HAND feasibility trial, SPIN Cohort participants with at least mild hand function~     limitations and an indicated interest in using an online hand exercise program will be~     randomized to be offered the SPIN hand exercise program or to usual care only. The core SPIN~     hand exercise program consists of 4 modules that address specific aspects of hand function,~     including Thumb Flexibility and Strength; Finger Bending; Finger Extension; and Wrist~     Flexibility and Strength. The program also integrates tools to support key components of~     successful self-management programs, including goal-setting.~      The aim of the SPIN-HAND feasibility study is to collect data to assess the feasibility of~     the steps that need to take place as part of the main trial; required resources; and~     scientific aspects (e.g., withdrawal rate, outcomes measures). Data will be used to determine~     whether it is feasible to carry out the main study or whether changes need to be made before~     conducting a full-scale RCT of the SPIN-HAND program.~   "
36258|NCT03092011|"~     The purpose of this study is to determine whether a medication, Clonidine can reduce the~     number of days a baby spends in the hospital and the number of days of medical treatment of~     withdrawal from Neonatal Abstinence Syndrome (NAS) as compared to Morphine Sulfate (used in~     routine care) .~   "
36259|NCT03091998|"~     The worldwide use of left ventricular assist devices (LVAD), which is mechanical device to~     improve hemodynamic function, has improved the outcomes of severe heart failure (HF) patients~     leading to the continued annual increase in the number of LVAD implantations. However LVAD~     support still results in major complications such as renal failure or gastrointestinal~     bleeding. The investigators hypothesize that such major complications may be due to~     endothelial dysfunction induced by the lack of pulsatility, which may be improved by an~     innovative designer natriuretic peptide, CD-NP. They have demonstrated its favorable actions~     in animal models as well as humans, and tested its safety in LVAD patients. They hypothesize~     that CD-NP will have renal and endothelial protective actions through its receptor GC-A and~     GC-B. Thus, the investigators will test their hypothesis with a highly translational approach~     to examine CD-NP's role in endothelial and renal protection.~      The aim is to determine safety and tolerability together with cGMP activating, neurohumoral~     modulating and renovascular protective properties of chronic subcutaneous delivery of CD-NP~     compared to placebo in stable LVAD patients for 3 days.~   "
36260|NCT03091985|"~     The purpose of this study is to investigate the efficacy of breast drainage of the healthy~     breast with the new Medela pump set breast shield (Brownie).~      The objective of the study is to verify the Brownie breast shield to be non-inferior to the~     current PersonalFit breast shield in emptying the healthy lactating breast.~   "
36261|NCT03091972|"~     Linear ablation is frequently used in the procedure for persistent atrial fibrillation.~     However, it has a limitation because of technical difficulty. Incomplete block is common and~     an important cause of atrial tachycardia.~      The association between contact force values and successful linear block has not been~     revealed yet. We aim to the effectiveness and safety of linear ablation by using CF sensing~     catheter.~   "
36269|NCT03091868|"~     To investigate the effect of rising oral single-doses of BIA 6-512 (25 mg, 50 mg, 100 mg and~     200 mg) on levodopa pharmacokinetics when administered in combination with a single-dose of~     immediate release levodopa/carbidopa 100/25 mg (Sinemet® 100/25) or with a single-dose of~     Sinemet® 100/25 plus a single-dose of entacapone (Comtan®) 200 mg and to assess the~     tolerability and safety of rising single oral doses of BIA 6-512 when administered in~     combination with a single-dose of Sinemet® 100/25 or with a single-dose of Sinemet® 100/25~     plus a single-dose of Comtan® 200 mg.~   "
36270|NCT03091855|"~     Patients will be screened at Intermountain Medical Center and at Intermountain affiliated~     anticoagulation clinics in the Salt Lake City region. Patients with atrial fibrillation that~     undergo a standard of care, clinically approved, left atrial appendage closure will be~     considered for study. All patients will be followed for 24 months, and will be assessed at~     the 3-, 6-, 12-, 18- and 24-months post-left atrial appendage closure as well as other visits~     deemed necessary for clinical care. All subjects will undergo protocol-specified laboratory~     tests and will complete 6 standard, validated questionnaires at each follow-up visit, except~     at the 3-month visit when only one questionnaire will be administered.~   "
36271|NCT03091842|"~     This randomized phase II trial studies how well exercise intervention works in targeting~     adiposity and inflammation with movement to improve prognosis in stage I-III breast cancer~     survivors. Different types of exercise may reduce inflammation in fat tissue and minimize the~     risk of cancer recurrence related to being overweight or obese.~   "
36272|NCT03091829|"~     Multicentric, prospective, non-interventional observational study with two parts:~        1. A register of quality assurance within the recertification of clinics~        2. An extended register with scientific protocol.~   "
36273|NCT03091816|"~     This pilot clinical trial studies the changes in dynamic perfusion computed tomography images~     before, during, and after stereotactic body radiation therapy in patients with stage I-II~     non-small cell lung cancer that has not spread to other parts of the body. Diagnostic imaging~     procedures, such as dynamic perfusion computed tomography, measure blood flow through tumors.~     Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays~     directly to the tumor using smaller doses over several days and may cause less damage to~     normal tissue. Giving dynamic perfusion computed tomography images before, during, and after~     stereotactic body radiation therapy may help better understand how radiation therapy works to~     stop tumor growth in patients with non-small cell lung cancer.~   "
36274|NCT03091803|"~     This randomized pilot clinical trial studies quantitative susceptibility mapping (QSM) and~     regional dynamic contrast enhanced (DCE) magnetic resonance imaging (MRI) permeability using~     golden-angle cartesian randomized time-resolved (GOCART) technique in evaluating regional~     gadolinium retention in the brain in patients with intracranial neoplasm receiving gadobenate~     dimeglumine or gadoterate meglumine. MRI diagnostic techniques such as, QSM and DCE MRI, may~     help to gather information regarding brain changes associated with gadolinium deposits during~     8 to 18 months after administration of gadobenate dimeglumine or gadoterate meglumine.~   "
36275|NCT03091790|"~     Ventral hernias are common following abdominal surgery. Currently, there is no equipoise on~     when synthetic and biologic meshes should be used. Among open ventral hernia repairs, half~     are repaired using biologic mesh while half are repaired using synthetic mesh. The~     investigators hypothesize that biologic mesh as opposed to synthetic mesh repair of open~     ventral hernia repair is associated with decreased risk of major complications one year after~     surgery.~   "
36276|NCT03091777|"~     This research study is being done to compare the safety and efficacy of GDC-229 (test drug)~     against the currently marketed reference drug (metronidazole 0.75% vaginal gel) and to~     establish that these two drugs work better than placebo in subjects with BV.~   "
36277|NCT03091764|"~     This project will develop and evaluate a patient-reported symptom index to assess the impact~     of treatment for non-muscle invasive bladder cancer on patient burden, toxicity, symptoms and~     side effects. The symptom index will provide a method for assessing treatments from the~     patient's perspective; help healthcare professionals make better informed treatment~     decisions, and provide a method to be able to effectively evaluate treatments for non-muscle~     invasive bladder cancer.~   "
36278|NCT03091751|"~     The goal of this non-randomized, multi-center study in subjects with severe hereditary~     haemophilia B was to determine and compare the pharmacokinetic and safety profiles of BeneFIX~     in subjects having had 2 prior pharmacokinetic assessments with AlphaNine.~   "
36279|NCT03091738|"~     To study the effect of ramelteon, a melatonin receptor agonist, on sleep quality, duration~     and cognitive function in cirrhotics with insomnia.~      Patients with cirrhosis have difficulties with their sleep quality, which adversely affects~     their health-related quality of life. It is assumed the sleep disturbances are related to~     hepatic encephalopathy (HE) in these patients. However, several recent reports have indicated~     that this is not a perfect concordance and that cognition is not related to sleep~     disturbance. The mechanism for this change is not clear, although there is evidence of~     melatonin-delayed phase in these patients as well as difficulties with the excretion pattern~     of cortisol. Ghrelin is an orexigenic hormone produced by the stomach which stimulates the~     appetite and also has a profound effect on sleep. Our group has demonstrated a substantial~     alteration in ghrelin secretion in cirrhosis that correlates with poor slow-wave sleep. In~     healthy individuals, ghrelin injection encourages slow-wave sleep while sleep deprivation~     increases ghrelin levels. The role of ghrelin in the sleep disturbances of cirrhosis has not~     been determined. Prior studies have also lacked the use of overnight polysomnography as a~     tool and have relied on either actigraphy or questionnaires. There is a need for detailed~     mechanistic and therapeutic approaches to analyzing sleep disturbances in cirrhosis.~      Also the therapy of sleep disturbance in cirrhosis is largely empirical. Prior studies have~     evaluated hydroxyzine which runs the risk of precipitating HE. Ramelteon is a melatonin~     analog that is FDA-approved for use in insomnia and will potentially be useful to restore the~     sleep-wake cycle in cirrhosis-associated sleep disturbance.~      The investigators aim to study the impact of the FDA-approved ramelteon on the sleep quality~     (using questionnaires and sleep diaries) on these patients with cirrhosis.~   "
36295|NCT03091530|"~     The primary purpose of this study is to determine if the loss of internal rotation following~     a throwing session is best restored through soft tissue stretching with the sleeper stretch~     or with scapular repositioning with the 90/90 hip lift with balloon blow exercise. This study~     will progress the body of research related to internal rotation deficits with regards to~     baseball throwers. The research will be relevant to clinicians who treat patients with~     baseball players with internal rotation loss.~      High school baseball players will be the targeted subjects for this study. They will perform~     two exercises (one per week) designed to increase shoulder internal rotation over the course~     of three weeks with one week of rest between intervention weeks. The primary outcome will be~     shoulder internal rotation range of motion improvements over the course of one week's time.~     There are no known adverse risks to either intervention.~   "
36280|NCT03091725|"~     Bariatric surgery markedly improves glycemic control in persons with T2D. Roux-en-Y gastric~     bypass (RYGB) a procedure that bypasses the upper gastrointestinal (UGI) tract results in~     greater rates of diabetes resolution compared to methods that leave the UGI tract intact.~     Studies suggest that mechanisms beyond weight-loss account for the superiority of RYGB~     compared to other surgical methods. These weight-loss independent metabolic effects may~     involve increased postprandial production and release of nutrition- responsive hormones.~     Fibroblast growth factor 21 (FGF21) is a nutrition-adaptive hormone with the potential to~     alleviate symptoms of diabetes and obesity. Preliminary data therefore suggests that RYGB~     surgery may alter postprandial FGF21 regulation which could be important for achieving~     post-meal nutrient homeostasis. Therefore, the goal of this study is to test how nutrient~     content of the meal affects FGF21 concentrations before and after weight loss induced by RYGB~     or very low calorie diet (VLCD) therapy. The importance of FGF21 for for glucose, insulin,~     triglyceride and adipose tissue and muscle metabolism in these two groups will also be~     tested.~   "
36281|NCT03091712|"~     This is an open label randomized, controlled, parallel intervention study. Group 1 will~     receive usual care for insulin degludec titration using the STEP WISE degludec titration~     algorithm Group 2 will receive Glooko mobile insulin dosing system, using the STEP WISE~     degludec titration algorithm.An estimated n= 240 subjects with type 2 diabetes will be~     enrolled in order to obtain approximately 200 evaluable subjects who will complete the 16~     week study.~   "
36282|NCT03091699|"~     Adult smokers will participate in a two stage testing trial, where the first stage will~     utilize a within-subject counterbalance design and individuals will participate in both~     conditions. The second stage will utilize a two-arm randomized control trail. The two~     conditions are (a) moderate intensity exercise and (b) nicotine inhalation. The primary~     measure of assessment will be reaction time and accuracy on the N-back task.~   "
36283|NCT03091686|"~     Societal changes have resulted in reduced demands to be active and increased daily time spent~     sitting. Excessive sitting has been shown to be a health hazard. The purpose of this study is~     to examine whether sedentary behaviour and diabetes information grounded in The Action~     Process Approach is a meaningful source of motivation to reduce daily sitting time among~     adult office workers. The intervention will target risk perceptions related to sitting by~     presenting research on prolonged sitting and diabetes risk, the effectiveness of breaking up~     prolonged sitting, and provide strategies to break up sitting. It is expected that~     participants who receive this information will report greater motivation and intentions to~     reduce both work and leisure sitting time.~   "
36284|NCT03091673|"~     This is a sequential efficacy and safety study in pediatric patients with type 1 diabetes.~     Subjects will be administered insulin to induce a low normal glycemic state and will then~     receive an age-appropriate dose of G-Pen™ (glucagon injection) in a clinical research center~     (CRC) or comparable setting.~   "
36285|NCT03091660|"~     This randomized phase III trial studies Tokyo-172 strain bacillus Calmette-Guerin (BCG)~     solution with or without a vaccination using Tokyo-172 strain BCG to see how well it works~     compared with TICE BCG solution in treating patients with bladder cancer that has not spread~     to muscle. BCG is a non-infectious bacteria that when instilled into the bladder may~     stimulate the immune system to fight bladder cancer. Giving different versions of BCG with~     vaccine therapy may prevent bladder cancer from returning.~   "
36286|NCT03091647|"~     This study develops and pilot tests the efficacy of a home-based, self-administered~     acupressure intervention in improving cancer-related fatigue (proximal outcome), and physical~     functioning and other quality of life outcomes (distal outcomes) of Chinese immigrant breast~     cancer survivors (versus usual care control group).~   "
36287|NCT03091634|"~     This is a multicenter, double-blind, randomized and placebo-controlled trial. The study aims~     to evaluate the effectiveness and safety of Xue-Fu-Zhu-Yu Capsule (XFZYC) for Qi Stagnation~     and Blood Stasis syndrome (QS&BSS). QS&BSS is one of the common Zhengs in Traditional Chinese~     Medicine, which manifests as various symptoms and signs, such as distending pain or tingling~     sensation in a fixed position, irritability or depression, dim complexion, lumps in body,~     blood spot under the skin, unsmooth or string-like pulse, purplish tongue or petechia in the~     tongue, etc. In fact, Qi stagnation and blood stasis are common pathological conditions that~     would occur on human body for several times in the long period of human's life. Besides,~     QS&BSS is associated with over 50 kinds of diseases including Coronary Heart Disease,~     hypertension, cerebral infarction, gastritis, arthritis, dysmenorrhea, chronic pelvic~     infection, skin disease, and cancer. Xue-Fu-Zhu-Yu Capsule, one of Chinese herbal medicine~     drugs, could perform the function of promoting Qi and activating blood to relieve the~     symptoms of QS&BSS, which was approved by the China Food and Drug Administration in 2002. It~     has been applied for QS&BSS since it was recorded in the book Correction on Errors in Medical~     Classics 200 years ago. In recent years, a number of clinical trials have focused on the~     effectiveness and safety of XFZYC on patients with QS&BSS subtype of coronary heart disease,~     hyperlipidemia, ischemic cerebrovascular disease, gastritis, dysmenorrhea, and arthritis in~     terms of the outcomes of relevant diseases. Our research group plan this randomized~     controlled trial to evaluate the effectiveness and safety of Xue-Fu-Zhu-Yu Capsule (XFZYC). A~     total of 120 patients will be enrolled at the following three hospitals: (1)Guang'anmen~     Hospital, China Academy of Chinese Medical Sciences, (2)Huguosi TCM Hospital Affiliated to~     Beijing University of Chinese Medicine, (3)Wangjing Hospital, China Academy of Chinese~     Medical Sciences, Beijing, China. All participants, with different kinds of disease, will~     receive the standard medical care according to the guidelines. Participants will undergo a~     7-week treatment. The primary outcome is the total score of the Traditional Chinese Medicine~     Patient Reported Outcome (PRO) Scale in Patients of QS&BSS; the secondary outcome is the~     score of the single symptom and sign scale of QS&BSS and the score of the pain scale of~     QS&BSS on the day of enrollment, and at 2nd, 4th, 6th, 7th weeks. Safety outcomes include~     physical examination (temperature, respiration, heart rate, blood pressure, height and~     weight); electrocardiogram (ECG); complete blood cell count; coagulation function~     (prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT),~     fibrinogen (FIB), D-Dimer, INR); urinalysis; fecal occult blood test; Liver function (ALT,~     aspartate aminotransferase (AST), alkaline phosphatase (ALP), serum total bilirubin (STB),~     and γ-glutamyl transpeptidase (γ-GT)); renal function (Creatinine (Cr), blood urea nitrogen~     (BUN), and urine N-acetyl-β glucosaminidase) on the day of enrollment, and at 7th weeks.~   "
36288|NCT03091621|"~     To clarify the effectiveness and safety of the direct factor Xa inhibitor rivaroxaban in~     domestic clinical use for patients with deep vein thrombosis and pulmonary embolism~   "
36289|NCT03091608|"~     This is a prospective registry study to surveil early liver injuries caused by Xianlin Gubao~     Granule (XLGB Granule) through a non-intervention observational way. And attempt to establish~     a predictive model to screen susceptibilities to XLGB Granule.~   "
36290|NCT03091595|"~     A combined oral contraceptive (COC) containing 15 mg E4 and 3 mg DRSP administered for 24~     days followed by 4 placebo tablets, is being evaluated for further development. This study~     will investigate the effect of this COC on ovarian function inhibition, levels of serum~     luteinizing hormone (LH), follicle-stimulating hormone (FSH), estradiol (E2) and progesterone~     during 3 treatment cycles in comparison with the reference COC 20 mcg EE/3 mg DRSP.~   "
36291|NCT03091582|"~     The primary objective of the proposed pilot study is to seek to compare the efficacy of two~     brief psychological therapies during inpatient hospitalization - cognitive behavioral therapy~     (CBT) versus Behavioral Activation for Medical Inpatients with Depression (BAMID or BA) - for~     improving depressive symptoms, functioning, and quality of life (QOL). The treatments will~     consist of four sessions, which will be delivered during hospitalization.~   "
36292|NCT03091569|"~     The primary objective of the study is to investigate whether topical Vitamin K application~     reduces the grade of erythema in comparison with a vehicle cream (placebo) through~     physicians' assessment and participant self-assessment.~      The secondary objectives of this study are to evaluate in this study population: effects of~     Vitamin K in reducing the burning sensation and local pain; effects of Vitamin K in reducing~     the erythema diameter; and the evaluation of participants' satisfaction related to the~     injection treatment.~   "
36293|NCT03091556|"~     This is a prospective registry study to surveil early liver injuries caused by Xianlin Gubao~     Pill (XLGB Pill) through a non-intervention observational way. And attempt to establish a~     predictive model to screen susceptibilities to XLGB Pill.~   "
36294|NCT03091543|"~     To investigate the effect of four single oral doses of BIA 6-512 (25 mg, 50 mg, 100 mg and~     200 mg) on levodopa pharmacokinetics when administered in combination with a single-dose of~     controlled release levodopa/benserazide 100/25 mg and to assess the tolerability and safety~     of four single oral doses of BIA 6-512 (25 mg, 50 mg, 100 mg and 200 mg) when administered in~     combination with a single-dose of controlled release levodopa/benserazide 100/25 mg.~   "
48508|NCT02932007|"~     The goal of this pilot study is to explore the efficacy of chloroquine in terminating~     persistent and longstanding persistent AF and assess its potential role as a pharmacological~     cardioversion agent for the management of AF.~   "
36297|NCT03091504|"~     High-humidity nasal cannula (HFNC) has been shown to be effective in improving oxygenation~     and avoiding intubation in multiple randomized control trials, it is also suitable and~     feasible for long term use. Aerosol delivery via HFNC will minimize interruptions and improve~     patient compliance, bench study and radionuclide imaging study done in healthy volunteers~     demonstrated that aerosol can be effectively delivered using HFNC. This study aims to~     evaluate the efficacy of bronchodilator delivered via HFNC in chronic pulmonary obstructive~     disease or asthma patients.~   "
36298|NCT03091491|"~     The purpose of this study is to determine whether Nivolumab in combination with Ipilimumab is~     associated with superior response rate compared to Nivolumab alone in patients with advanced~     Epidermal Growth Factor Receptor (EGFR) mutation positive Non-small Cell Lung Cancer who have~     failed one line of standard EGFR tyrosine kinase inhibitor and not more than one line of~     chemotherapy regimen. This study also aims to determine predictive biomarkers of~     response/benefit in patients with EGFR mutation positive NSCLC.~   "
36299|NCT03091478|"~     This is an open-label phase II study of pembrolizumab in patients with advanced solid tumors~     with leptomeningeal carcinomatosis (LMD). Patients may have received any number of prior~     therapies for their respective solid tumors, but must not have received prior anti-PD-1~     therapy and developed progressive disease. Approximately 18 subjects in this study will~     receive pembrolizumab at a dose of 200mg intravenously (IV) every 3 weeks (Q3W) for 4 doses.~     In patients who derive clinical benefit from therapy, pembrolizumab may be continued until~     documented disease progression, unacceptable adverse event(s), intercurrent illness that~     prevents further administration of treatment, investigator's decision to withdraw the~     subject, subject withdrawal of consent, noncompliance with trial treatment or procedure~     requirements, or for administrative reasons.~   "
36300|NCT03091465|"~     This is a nation-wide retrospective observational study which will be performed in 50 centres~     in Spain, geographically representative of all regions, with at least 5 patients treated with~     first-line pazopanib for mRCC in daily clinical practice since April 2011 (date of approval~     of pazopanib in Spain), January 2016.~      Pazopanib is one of the standard tyrosine-kinase inhibitors (TKI) for the first-line~     treatment of metastatic renal cell carcinoma. In our previous SPAZO study, the Spanish~     Oncologic Genitourinary Group (SOGUG) validated the IMDC prognostic classification for~     patients receiving first-line pazopanib, and demonstrated the effectiveness of this drug in~     routine clinical practice. However, in this series of 278 patients, we could not obtain~     enough information on the effectiveness of pazopanib in special subpopulations such as~     non-clear cell histologies, and others subgroups, due to a small simple size of each of these~     subpopulations. On the other hand, after the results of RECORD-1 and AXIS trials, switching~     to everolimus or axitinib is the current approach for patients who progresses to a first-line~     TKI. However, these pivotal studies did not include patients treated with first-line~     pazopanib study because this drug was not available at that time. The results of the SPAZO~     study also suggested that the effectiveness of second-line targeted therapies (TT) after~     pazopanib in routine clinical practice is similar to the observed in clinical trials after~     sunitinib, sorafenib or bevacizumab. In addition, the preliminary results indicated that~     there are not meaningful differences in the effectiveness of TKI or mTOR inhibitors after~     pazopanib, when the results are adjusted by the IMDC prognostic classification. However, the~     IMDC prognostic classification for second-line TT has not yet been validated for patients who~     receive pazopanib as first-line. In addition our sample size was not large enough to make a~     comparison of effectiveness between mTOR inhibitors and antiVEGF for each prognostic~     subgroups of the IMDC.~      Based on that, the Spanish Oncologic Genitourinary Group has decided to launch the SPAZO-2~     study, in which we intend to prolong the follow up of patients included in SPAZO, and to~     increase the sample size with new patients from new centres, in order to obtain a larger~     sample in each of the subpopulations of interest, with the objective of obtaining more~     information about the above questions.~   "
36301|NCT03091452|"~     CASE AF aims to describe the reality of medical care of patients in whom atrial fibrillation~     is treated by cardiac surgical ablation.~   "
36302|NCT03091439|"~     This clinical study will be a multi-center, randomized, open-label, active-controlled,~     parallel-group study comparing dalbavancin to standard of care (SOC) therapy in~     osteomyelitis.~   "
36303|NCT03091426|"~     This study has a randomized, double-blind, placebo-controlled design to assess the efficacy,~     pharmacodynamics and safety/tolerability of omiganan in patients with mild to moderate atopic~     dermatitis when applied BID to all atopic dermatitis lesions.~   "
36304|NCT03091413|"~     This study evaluates the correlation between maximum inspiratory pressure (Pi max) and the~     diaphragm maximum inspiratory excursion measured with ultrasound during the weaning from~     invasive mechanical ventilation.~   "
36305|NCT03091400|"~     The purpose of this crossover trial is to investigate whether atomoxetine (versus placebo)~     improves memory function in persons with memory deficits due to multiple sclerosis.~   "
36306|NCT03091387|"~     Intubation and ventilation are lifesaving interventions in the neonatal intensive care unit~     (ICU), especially among preterm, low birth weight babies. However, timely extubation is also~     necessary. The decision to extubate usually depends on clinical judgement, appropriate blood~     gas prior to extubation and low ventilator parameters. Approximately 40 % of babies'~     extubated on the above criteria require re-intubation, suggesting that current methods to~     predict extubation failure are insufficient. . Spontaneous breathing trial (SBT) has been~     predominantly used in infants and children to access the readiness for extubation. Few~     studies in premature neonates have also shown good sensitivity and specificity in predicting~     extubation success. However its significance in our population is yet to be determined. We~     aim to use this for both our preterm and term babies and if results are significant we plan~     to include this as our routine pre extubation criteria.~   "
36307|NCT03091374|"~     Antiretroviral therapy (ART) has improved the health of more than 18 million people infected~     with HIV by controlling viral replication, AIDS and non-AIDS events, and by reducing the risk~     of transmission. However, the existence of latent viral reservoirs in long-lived memory CD4 T~     cells remains a hurdle to curing HIV infection; consequently patients must remain on ART for~     the rest of their lives. Recently, a more realistic approach under limelight is to identify~     strategies leading to a functional cure, which is defined as the natural control of viral~     reservoir by the host. Use of recombinant human growth hormone has been shown to improve~     immune function by several mechanisms. This study hypothesizes that treatment with~     recombinant human growth hormone will decrease the size of the replication competent HIV~     reservoir in HIV-infected immune-reconstituted individuals.~      The specific study objectives include:~        -  To evaluate the effect of recombinant human growth hormone administration for 48 weeks~          on the size of the replication competent HIV reservoir~        -  To evaluate the safety and tolerability of recombinant human growth hormone~          administration for 48 weeks in HIV-infected individuals on suppressive ART.~      For this purpose, the investigators will add recombinant human growth hormone treatment for~     the patients receiving stable ART. Approximately 22 participants will be enrolled in this~     study at the Chronic Viral Illness Service of the McGill University Health Centre (Montreal,~     Canada), which will last about 52 weeks. Participants will be treated with recombinant human~     growth hormone for a total of 48 weeks. The initial recombinant human growth hormone dose~     will be 3 mg/day (30-40 µg/kg/d) for 24 weeks administered by subcutaneous injection on an~     outpatient basis, followed by dose reduction to 1.5 mg/day for the final 24 weeks of the~     treatment period, also conducted on an outpatient basis. The study inclusion criteria include~     male and female participants, ≥18 and <40 years of age, with an undetectable viral load (the~     quantity of the HIV virus in the blood must be less than 50 copies/ml) during last 24 months~     and with a CD4 T-cell count ≥350 cells/mm3 obtained within 30 days prior to study entry. The~     findings from this study will contribute to the development of novel strategies to eradicate~     HIV.~   "
36308|NCT03091361|"~     This is a non-randomized, single-blind post market clinical follow-up study for which 50~     patients will be imaged at the Judy Dan Research and Treatment Centre who present with a~     chronic and are receiving standard wound care treatment. The i:X imaging device visualizes~     fluorescing bacteria in real-time. The device will be used as an adjunctive tool in the~     assessment of the wound and will be used to guide the targeted sampling of a wound (with~     curettage scraping). The overall objective of this work is to evaluate the positive~     predictive value (PPV) of the MolecuLight i:X Imaging Device in predicting the presence of~     bacteria in chronic wounds. The presence of bacteria will be determined micro-biologically by~     semi-quantitative culture analysis.~   "
36309|NCT03091348|"~     In this randomized, cross‐over study 20 subjects who are undergoing testosterone (T) therapy~     for the treatment of T deficiency will receive both subcutaneous testosterone therapy and~     intramuscular testosterone therapy. One group will receive a SQ injection followed by an IM~     injection and one group will receive an IM injection followed by a SQ injection. The primary~     objective of this study is to measure testosterone concentration in men after these two~     treatment routes and determine if there are any significant differences due to modes of~     administration. Endpoints will include total serum testosterone and calculated free~     testosterone. A questionnaire will also be administered to assess overall patient experience~     with each route of administration.~   "
36310|NCT03091335|"~     This study aims to demonstrate that music listening in patients undergoing awake deep brain~     stimulation reduces subjective and objective measures of anxiety. Furthermore, the~     investigators aim to demonstrate that music may alter neuronal firing patterns based on the~     type of music played and the location in the brain.~   "
36311|NCT03091322|"~     This study is designed as post market clinical follow-up study with CE-marked products to~     evaluate the AV Opt and LV VectorOpt features in the respective Edora family pacemakers under~     clinical conditions. Furthermore, adverse events will be evaluated to identify residual risks~     associated with the use of the BIOTRONIK Edora family pacemakers. The study is further~     designed to address potential regulatory needs of clinical data for countries and regions not~     covered by the CE approval.~   "
36312|NCT03091309|"~     Inflammatory Bowel Disease (IBD) is a chronic inflammatory disorder of the gastrointestinal~     tract that comprises two subtypes, Crohn's disease (CD) and Ulcerative Colitis (UC). Because~     the risk of IBD is greatest during the third decade of life, its impact for women is during~     the reproductive years. Women with inflammatory bowel disease are at a 2-fold higher risk of~     adverse outcomes during pregnancy as compared to the general population. Pregnancy is an~     especially vulnerable time for women with IBD, and out of misguided concerns that medications~     may confer unnecessary harms to their fetus, many women often stop taking life savings~     medications; without realizing that this sub-optimal adherence could actually lead to life~     threatening complications for them and their fetus. Counseling pregnant women with IBD is~     therefore an important step in improving medication adherence. The investigators hypothesize~     that counseling sessions with an IBD nurse that incorporates motivational interviewing and~     telemedicine-based follow-up sessions tailored to individual needs will improve medication~     adherence and pregnancy outcomes.~      The following specific aims are to be addressed by this multi-center randomized clinical~     trial comparing individual nurse-based counseling to standard of care:~      Specific Aim #1: To assess whether patient-centered counseling incorporating motivational~     interviewing and telemedicine-based follow-up by an IBD nurse leads to improved medication~     adherence during pregnancy and pregnancy outcomes~      Specific Aim #2: To validate the use of self-reported medication adherence during pregnancy~     in the IBD population~   "
36313|NCT03091296|"~     In this case‐controlled, observational study, 24 subjects will participate in a 12‐hour blood~     collection with a single blood draw at +24 hours. 12 men will have low testosterone levels~     (hypogonadism) and 12 men will have normal testosterone levels. Blood samples will be drawn~     every 2 hours and later analyzed for total testosterone and calculated free testosterone. The~     primary objective of this study is to assess the degree of diurnal variation in men with~     testosterone deficiency.~   "
36314|NCT03091283|"~     Nurse anaesthetist student is a registered nurse who spends 1- year training in anaesthesia,~     has to work laboriously to cope with all assigned activities day and night. Time management,~     therefore, becomes a practical tool for nurse student to reach her goal. However, many~     factors act as barriers to nurse students' attaining and maintaining a high grade point~     average (GPA). Investigators would like to determine the effect of skills in time management~     on GPA amongst faculty nursing students.~   "
36315|NCT03091270|"~     This study was designed to collect a series of patients with gliomas which were involved in~     motor cortex to analyze difference accuracy of motor cortex localization between BOLD-fMRI~     and ZOOMit-fMRI.~   "
36316|NCT03091257|"~     This research study is studying a targeted therapy as a possible treatment for multiple~     myeloma.~      The names of the study drugs involved in this study are:~        -  Trametinib~        -  Dabrafenib~   "
36317|NCT03091244|"~     This is a prospective registry study to surveil early liver injuries caused by Xianlin Gubao~     Capsule (XLGB Capsule) through a non-intervention observational way. And attempt to establish~     a predictive model to screen susceptibilities to XLGB Capsule.~   "
36318|NCT03091231|"~     The primary objective of the study is the matching of sensitivity, specificity, the negative~     predicate value and the positive predictive value of Contrast-Enhanced Ultrasound (CEUS),~     Shear Wave Elastography (SWE) and the combination to detect clinically significant prostate~     carcinoma foki.~      Conventional ultrasound is insufficient to safely display prostate carcinoma. Therefore,~     other imaging agents are recently added to improve the detection of tumor foci. These include~     innovative imaging ultrasound methods and multiparametric MRI.~   "
36319|NCT03091218|"~     This is a prospective registry study to surveil early liver injuries caused by Runzao Zhiyang~     Capsule (RZZY Capsule) through a non-intervention observational way. And attempt to establish~     a predictive model to screen susceptibilities to RZZY Capsule.~   "
36320|NCT03091205|"~     It's hypothesized that a mean and range distance from the cavo-atrial junction to the area~     where there is complete loss of conductive tissue can be measured to better inform surgeons~     performing the Cox-Maze procedure. A patient scheduled for any cardiac surgery where~     visualization and mapping of cavo-atrial junction is possible could be entered into the study~     if they meet the inclusion/exclusion requirements.~   "
36322|NCT03091179|"~     The purpose of this study is to investigate whether selected, short laryngologic surgical~     procedures can be safely and potentially more effectively performed without the use of~     endotracheal tube or jet ventilation, under completely tubeless conditions. The patient's gas~     exchange will be supported by rapid insufflation of high-flow oxygen through specialized~     nasal cannulae: the so called Transnasal Humidified Rapid- Insufflation Ventilatory Exchange~     (THRIVE).~   "
36323|NCT03091166|"~     Investigation of effect of perioperative Dexmedetomedine administration on mortality, length~     of ICU stay, delirium onset, heart failure, acute kidney injury, SIRS in cardiac surgery~     patients.~   "
36324|NCT03091153|"~     This study will develop, implement and evaluate a deprescribing initiative at a Canadian Long~     Term Care (LTC) Facility. Residents currently undergo an annual medication review as part of~     the clinical pharmacy services provided in the LTC facility. For this study, eligible~     residents will be randomized to receive either a deprescribing focused medication review or~     usual care.~      The deprescribing focused medication therapy assessments will be done on half of the 143~     residents residing on the second and third floors of the facility. The other half of~     residents will serve as the control group and continue to receive their annual medication~     review and regular care from the attending physicians and nurses.~      The deprescribing intervention will be delivered by final year pharmacy students completing~     their practice experiences, under the supervision of clinical pharmacists at the LTC facility~     and clinical pharmacists from Memorial University's Medication Therapy Services (MTS) Clinic.~     Currently the clinic has a well developed procedure for providing in depth medication therapy~     reviews for residents of the community, upon referral by their primary care physician.~     Students will adapt this model of medication review to have a stronger deprescribing focus~     and be applicable to elderly residents of a LTC facility. The intervention will consist of an~     in depth medication therapy review with a focus on identifying any medications that may no~     longer be required or are deemed to be inappropriate or potentially unsafe in the elderly~     based on currently guidelines/criteria. The students will work closely with members of the~     resident's care team on a daily basis, as well as the resident and their family, to develop~     and implement a deprescribing plan.~   "
36325|NCT03091140|"~     Protocol title: Alterations in functional characteristics of the muscle tissue following~     surgery for primary hyperparathyroidism.~      Purpose: To detect any changes in functional characteristics of muscles in patients who~     undergo surgery for primary hyperparathyroidism compared to patients with primary~     hyperparathyroidism and conservative treatment, patients undergoing thyroid surgery and~     healthy subjects.~      Design: Prospective, multi-center observational study Patient Population: Male or female~     subjects 18 years of age or older scheduled for parathyroidectomy No. of Subjects: 50~     patients undergoing parathyroidectomy, 50 patients undergoing conservative follow up, 50~     patients undergoing thyroid surgery due to nontoxic multinodular goiter or solitary nontoxic~     thyroid adenoma and 50 healthy control subjects, estimated up to 12 months to enroll.~      Duration of Treatment: During the operation Duration of Follow-up: Follow-up will be~     performed daily during hospitalization and at 3, 6 and 12 months after the procedure~     Endpoints: To evaluate the changes in functional characteristics of all the type of muscles~     which occur after parathyroidectomy for primary hyperparathyroidism.~   "
36326|NCT03091127|"~     With the recent addition of carfilzomib as a treatment option for multiple myeloma, no data~     is available yet on how the drug is being used outside of the clinical trial setting.~      This study will therefore provide essential data to demonstrate the real world utilization of~     carfilzomib in routine clinical practice, including dosage, administration schedule, regimen,~     duration of treatment and reason for discontinuation in Europe.~   "
36327|NCT03091114|"~     Background:~      A predictive factor is a measure that predicts treatment response. Decisions on internal~     fixations of lower limb fractures should regard predictive factors to personalize (e.g. age)~     treatment. However for most potentially influencing factors valid data on the predictive~     value is sparse.~      Objectives:~      The objective of this study is to identify predictive factors and quantify their predictive~     ability for treatment failure in patients with limb fractures treated with osteosynthesis.~      Methods:~      Patients Adult patients (≥18 year) with isolated fractures scheduled for urgent or~     semi-urgent surgery using internal fixations because of lower limb fractures.~      The predictive value of the following exposures will be analyzed:~        -  Age~        -  Gender~        -  Diabetes~        -  Smoking status~        -  Body Mass Index~        -  Open fractures~        -  Peripheral arterial disease~      Outcome The outcome will be (time to) reoperation of the same fracture because of failure of~     internal fixation due to nonunion or implant failure.~      Study design A prospective observational cohort study will be performed. Sample size 300~     patients will be included.~      Statistical analysis:~      For the main analysis a multivariate stratified Cox proportional hazard model will be used.~     The Model will be stratified according to the indication. In the Cox proportional hazard~     model all predictive factors will be entered simultaneously to quantify the independent~     influence (adjusted for all other factors) of each factor. The strength of prediction will be~     described with hazard rations and their corresponding 95% confidence intervals.~   "
36328|NCT03091101|"~     The purpose of this study is to investigate changes in corneal innervation during scleral~     contact lens wear in a keratoconic population. Specifically, changes in corneal sensitivity~     and nerve fiber density from baseline in the central and mid-peripheral corneal locations~     will be measured over a 6-month lens wear period. An additional aim of the study is to~     investigate the impact of scleral lens wear on corneal inflammation within the same study~     group. This will be achieved by comparing dendritic cell density change from baseline over~     the study period.~   "
36329|NCT03091088|"~     According to the World Health Organization criteria, osteoporosis was defined as a bone~     mineral density that lies 2.5 standard deviations or more below the average value for young~     healthy women. Osteoporosis is a major cause of fractures and can lead to serious~     complications in postmenopausal women. For this reason, approaches to prevent the appearance~     and progression of osteoporosis are of primary importance. This randomized clinical trial~     analyzes the effects of two types of physical exercise oriented to prevent osteoporosis in~     postmenopausal women with pharmacological supplements of Calcium and Vitamin-D.~   "
36330|NCT03091075|"~     This study is about healing after a rotator cuff tear repair procedure. We hope to learn if a~     biologic medication: Oxandrolone, a synthetic derivative of the human hormone Testosterone~     (the principal male sex hormone and an anabolic steroid), given for 12 weeks following~     rotator cuff repair, is effective in aiding in the healing process and restoring muscle mass.~   "
36331|NCT03091062|"~     The aim of this study is to assess the effectiveness of an Airway Clearance System.~   "
36332|NCT03091049|"~     An open label observational clinical study to compare the efficacy of EMLA cream (lidocaine~     2.5% and prilocaine 2.5% in a ratio of 1:1 by weight) in comparison to the established local~     anesthesia (LA) protocol of lidocaine subcutaneous injection, in providing adequate~     peri-operative local anesthesia during transradial coronary angiography~   "
36333|NCT03091036|"~     The aim of this study is to assess the effectiveness of proactive and integrated healthcare~     program for chronic complex patients (CCP). This program are based in coordination the~     primary level of attention with and speciality level. The objective is reducing hospital~     readmissions and know the benefit in total cost of care in 4 month before and 4 after~     intervention.~   "
36334|NCT03091023|"~     This project aims to study the endometrial transcriptome at the single cell level in both~     endometrial native tissue (biopsies) and endometrial fluid. Basically, the goals are: 1) To~     use the resolution provided by single-cell RNA-seq to deconvolute real time dynamics in~     endometrium transcriptome throughout the menstrual cycle from artifacts produced by known~     population heterogeneity, and 2) To use endometrium fluid to replace endometrium biopsies as~     signal source to develop a new diagnostic platform to determine the endometrium receptive~     state which is high resolution and minimally invasive. This study will provide an~     unprecedented high-resolution characterization of the endometrium cellular hierarchy via~     whole transcriptome analysis throughout the menstrual stages. These results will lead to a~     robust definition of stage-defining gene expression signatures and resolve the long-standing~     inconsistencies originating from bulk tissue studies. The dataset will be further explored~     via informatics tools to provide biological insights into the dynamics of endometrium and~     initiate new anchor points for functional studies.~   "
36335|NCT03091010|"~     Study population: Patients attending the Out Patient Department and admitted to Institute of~     Liver and Biliary Sciences.~      Study design: Prospective randomized controlled trial Study period: One year- January 2017-~     December 2018 Sample size: 130 (65 cases in each group) Intervention: The subjects will be~     given Fecal Microbiota Transplantation through a NJ tube placed after admission to the~     hospital. Participants will be administered the processed fecal microbiota sample collected~     from a related or unrelated healthy donor for a period of 7 days.~      Monitoring and assessment:~      The recipient will be monitored every day after Fecal Microbiota Transplantation therapy.~      The recipient will undergo physical examination, complete blood counts, at baseline and a~     chest X ray, serum procalcitonin, CRP and Tumor Necrosis Factor alpha levels, Liver Function~     Tests, Kidney Function Tests, International Normalized Ratio and arterial ammonia, at day~     0,4,7,14,28,90,180,270 and 365 from the start of therapy.~      Microbiota analysis of the donors will be done at baseline and the recipients will be done on~     day 0,7,28,90 & 180.~   "
36336|NCT03090997|"~     Hormonal and metabolic changes because of postmenopause increase body weight, central~     abdominal fat, alter lipid profile and insulin resistance, those factors increase the risk up~     to 60% to develop metabolic syndrome, diabetes and cardiovascular diseases. Because there is~     no efficient antioxidant therapy in postmenopausal women, this study proposes a therapy with~     resveratrol and vitamin C to increase the total antioxidant capacity; as well as to decrease~     insulin resistance and in consequence decreased the risk of diabetes, metabolic syndrome and~     cardiovascular disease~   "
36337|NCT03090984|"~     Every patient included in the study will undergo 3 standardised hemodialysis treatments, each~     using a different dialysis membrane (PMMA, PS, AN69ST). The order of the membranes used will~     be randomized.~      During each conventional and standardised hemodialysis treatment, 6 blood samples will be~     taken at different time points (T0, T5, T15, T30, T90, T240) to evaluate coagulation~     activation (TAT, PF1+2, d-dimers, TF) and, more specifically, activation of the contact phase~     pathway of coagulation (kallikrein, fXIa, fXIIa).~   "
36338|NCT03090971|"~     This is an open, controlled, prospective, proof-of-concept study, in 7 patients presenting~     NF1 and cutaneous neurofibromas. This study will include three treatment visits to the study~     center and three follow-up visits. Treatment will consist of two stages: neurofibroma~     microporation using the laser device, followed by topical application of one drop of~     diclofenac 25mg/ml on the surface of the neurofibroma; followed by re-application of one drop~     of diclofenac, twice daily, for three days. The applications subsequent to the first~     application will be performed by the patients. Subjects will return to the study center at~     three day intervals (Assessments 2 & 3) for new microporation and topical diclofenac~     application, followed by at-home topical diclofenac application for three more days.~     Assessment 4 will take place 3 days after Assessment 3. Assessment 5 will take place 7 days~     after the end of the treatment period and Assessment 6 at 30 days after the last application~     of study drug. The primary efficacy variable in this study is the inflammatory process with~     the presence of tissue necrosis. The primary safety variable is the occurrence of adverse~     events considered to be associated with the study drug, occurring during the treatment~     period.~   "
36339|NCT03090958|"~     AllyQuest is a novel, high impact secondary prevention intervention delivered via mobile~     phones to improve linkage and engagement in care among newly diagnosed HIV+ young men who~     have sex with men (YMSM). The features of the intervention aim to target previously~     identified barriers to care among newly diagnosed youth, namely, low HIV health literacy,~     lack of social support, and internalized stigma related to their diagnosis. AllyQuest will be~     an interactive mobile phone intervention for HIV+ YMSM that utilizes social networking,~     game-based mechanics and a story-based framework to guide behavior change. Grounded in Social~     Cognitive Theory, narrative communication and the principles of persuasive technology, the~     intervention is designed to capitalize on social involvement as a means through which HIV+~     YMSM can receive information and social support, experience social norms and reflective~     appraisals, and feel a sense of connectedness to peers.~   "
37916|NCT03070340|"~     The purpose of this study is to compare the diagnostic accuracy of breast magnetic resonance~     imaging (MRI) and contrast enhanced digital mammography (CEDM) in assessing the residual~     disease extent in patients who have completed neoadjuvant therapy (NAT).~   "
36340|NCT03090945|"~     The goal of this study is to identify significant clinical and laboratory risk factors in~     pediatric patients with significant upper gastrointestinal bleeding. This is defined as~     bleeding that necessitates an upper endoscopic evaluation to either diagnose or treat upper~     GI bleeding during their hospital admission. If a predictive/risk stratification relationship~     exists, these data could permit a more effective triaging and intervention scheme in~     pediatric patients presenting with complaints of gastrointestinal bleeding. In addition we~     want to get a better understanding of the re-bleeding rate after endoscopic therapy for upper~     GI bleeding and if there are any identifiable risk factors for re-bleeding. Lastly we want to~     understand best practice management for upper GI bleeding.~   "
36341|NCT03090932|"~     Amyotrophic lateral sclerosis (ALS) is a devastating neurodegenerative disorder characterized~     by progressive muscle weakness and eventual death. Studies demonstrate that the immune system~     plays a key role in ALS progression; however, the role of the immune system is unclear, as~     various aspects can play both a beneficial and detrimental role in the disease course.~     Attempts to universally suppress the immune system in ALS patients have at best had~     negligible effects on progression or at worst accelerated the disease. Thus, there is a~     critical need to identify immune cell populations to serve as biomarkers and therapeutic~     targets.~   "
36342|NCT03090919|"~     Sepsis is life-threatening and dysregulated response to infection that results in endothelial~     activation and dysfunction that leads to systemic microvascular leak and multiple-organ~     failure. This study will identify patients that have sepsis with thrombocytopenia and~     randomize them to receive a unit of platelets or an equivalent volume of saline.~   "
36343|NCT03090906|"~     The goal of this study is to compare clinical and histologically the soft tissue changes in~     terms of volume gain and stability around dental implants in cases where a subepithelial~     connective tissue graft from the palate or from the tuberosity is used randomly~   "
36344|NCT03090893|"~     The objective of this study will be to prospectively evaluate the response of a continuous~     infusion of recombinant human antithrombin concentrate (rhAT) (ATRYN®) to achieve and~     maintain the AT activity within a specified range in adult patients that require~     extracorporeal membrane oxygenation (ECMO) following cardiopulmonary bypass (CPB) and cardiac~     surgery.~   "
36345|NCT03090880|"~     Prospective randomized open multicenter trial with blinded adjudication of endpoints to~     assess the efficacy of six-month low-dose LMWH for the prevention of symptomatic or~     incidental VTE in patients with stage IV lung cancer and elevated D-dimer.~   "
36346|NCT03090867|"~     ICUs have always perceived by the public has a very technical unit with a restricted and/or~     forbidden access. Physical alteration of the patient, seeing the patient sedated, the large~     numbers of devices, the alarms and an uncertain prognosis. All this factors can be perceived~     by people close to the patient as a source of stress. In the literature, numerous studies~     have shown that families develop anxiety and depression symptoms while their loved one is~     hospitalized in the ICU. French intensive care societies thought of ways to prevent or~     diminish these symptoms. The 6th consensus conference on  Live better in the ICU ~     recommends: effective and adapted information, large visiting hours to reach an unrestricted~     access and family participation in care.~      The unit has taken this path to improve patient and family centered care by: creating a~     welcome leaflet, a room dedicated to meetings with families and an ICU open 24/7bto families,~     with the possibility for children to visit their parents. Hence, spontaneously, relatives~     have expressed the wish to participate to certain care and when participating, expressed~     their satisfaction. This observation and testimonies from family members and patients led us~     to think about the impact of participation of care. Two major French studies have shown~     contradictory outcomes: 16% of families would have been willing to participate in the first~     study against 97% in the second one. These studies were survey done after the ICU discharge.~      No study today has assessed the actual impact of family participation in care. The aim of~     this clinical trial is to diminish anxiety and depression symptoms. By participating in care,~     relatives can develop or strengthen a relationship of trust with caregivers. It could~     contribute also to a better understanding of the plan of care and an easier context to~     announce negative outcomes.~   "
36347|NCT03090854|"~     Several previous studies have assessed acetylcholine (Ach) and acetylcholinesterase activity~     (AchE-a) levels in Alzheimer's disease (AD) pathophysiology. The cerebrospinal fluid (CSF)~     Ach level was significantly decreased in AD patients, and correlated positively with dementia~     score and MMSE (1, 2). Two studies have demonstrated positive correlations between CSF AchE-a~     and CSF Tau, phosphorylated-Tau (P-Tau) and AB 1-42 peptide (3,4). ChEIs (cholinesterase~     inhibitors) have been approved for the treatment of AD but only 20 to 30 % of patients are~     responders (5). Any consistent data allow the clinician to predict the response to the~     treatment. The link between basal cholinergic status and ChEIs efficiency has never been~     done. Even if, there is a wild research in AD treatment, ChEIs or treatment acting on the Ach~     pathways will remain a long time valuable treatment particularly in moderate AD in which~     disease modifying therapies did not show any efficiency.~      The investigators's objective is to prospectively explore the predicting value of CSF Ach and~     AchE-a levels on ChEIs response in AD patients.~   "
36348|NCT03090841|"~     The purposes of this study are to determine 1) if the diagnosis of CMV fetal infection could~     be done directly in the maternal blood instead of requesting an amniocentesis and 2) if~     innovative technologies such as proteomic, transcriptomic, methylomic and lipidomic applied~     in fetal samples could allow the discovery of new biomarkers of fetal infection.~   "
36349|NCT03090828|"~     1600 patients with severe, end stage renal disease or post transplant will be randomised~     1:1:1 to either standard therapeutic education; or education using a specific app; or the~     enhanced interactive app using feedback messages.~      The total follow up duration is 18 months. Primary endpoint is the cost utility of using~     app-based therapeutic intervention, secondary endpoints are: compliance with treatment~     guidelines, app use (professionals and patients), budget impact analysis~   "
36360|NCT03090685|"~     Chikungunya fever is an acute viral disease, transmitted by the mosquito (Aedes aegypti),~     that triggers pain and disabling rheumatic manifestations. There is no cure for this disease,~     and the usual treatment is directed at relieving symptoms through the use of analgesics and~     antipyretics. Due to the risk of adverse effects triggered by prolonged use of analgesic and~     anti-inflammatory drugs, the use of complementary therapies, such as Auriculotherapy, might~     be a safe and effective non-pharmacological treatment for the management of Chikungunya~     symptomatic cases.~      Subjects diagnosed with Chikungunya and undergoing routine treatment will receive~     auricotherapy treatment once a week, for five weeks. Subjects will be assessed at baseline~     and after 4 and 8 weeks after intervention. This study might help understand the use of~     Auriculotherapy as a complementary treatment in the treatment of physical and functional~     symptoms of individuals infected by Chikungunya .~   "
36350|NCT03090815|"~     Lung cancer is the leading cause of cancer death in the U.S. and throughout the world. Lung~     cancers are broadly divided histologically into small cell lung cancer (SCLC) and non-small~     cell lung cancer (NSCLC). About 25% of patients with NSCLC have stage I or II disease. The~     primary treatment modality is surgical resection,2 and 5-year survival rates are 65% for~     stage I and 41% for stage II disease. However, more than 70% of patients with NSCLC present~     with stage III or IV disease. Patients with stage III disease are most commonly treated with~     chemoradiation, and 5-year survival rate is 26%. Chemotherapy and targeted therapy are often~     used for stage IV disease, which has a 5-year survival rate of 4%.~      Tyrosine kinase inhibitor (TKI) is a targeted therapy against specific molecules in critical~     cell-signaling pathways involved in lung carcinogenesis. The currently available FDA approved~     TKIs for advanced NSCLC include afatinib, gefitinib, and erlotinib that inhibit epidermal~     growth factor receptor (EGFR) signaling 6 and crizotinib that inhibits anaplastic lymphoma~     kinase (ALK) signaling. However, only tumors that carry the corresponding oncogenic mutations~     (e.g., sensitizing EGFR mutations) would respond well to these TKIs. Meta-analyses of~     clinical trials evaluating the efficacy of gefitinib and erlotinib have demonstrated that~     NSCLC patients who are EGFR mutation-positive have a lower risk of disease progression when~     treated with an EGFR-TKI as compared to those treated with chemotherapy (HR = 0.43, 95%~     confidence interval, CI=0.38-0.49). EGFR-TKI, however, confers no benefits to patients who~     are EGFR wildtype (HR = 1.06, 95% CI=0.94-1.19). A phase III trial of crizotinib has also~     demonstrated the superiority of crizotinib to standard chemotherapy in ALK-positive NSCLC~     patients (HR = 0.49; 95% CI=0.37-0.64).~      In Hong Kong, as in other parts of Asia like in China and in Taiwan, other than the majority~     of lung cancer patients being smokers, there is also a prominence of non-smokers in lung~     cancer. Compared with Caucasians, there is also a relatively higher incidence of EGFR~     mutation in lung adenocarcinomas. The prevalence of EGFR mutation in Asian population with~     lung adenocarcinomas can reach up to 60% compared to at most 30% in the Caucasian population.~     These EGFR mutant tumors will demonstrate better response to the drug EGFR-TKI, boosting up~     the response rate to almost 70% compared to 30% with conventional chemotherapy for lung~     cancer. Even with this remarkable response, however, EGFR-TKI will eventually fail in EGFR~     mutant lung cancer. There is an imminent need to look for newer therapeutic targets or agents~     that can overcome this acquired resistance to anti-cancer drugs and to explore alternative~     molecular signaling pathways that could interact or enhance EGFR signaling pathways to~     modulate the therapeutic response in lung cancer.~   "
36351|NCT03090802|"~     This study aims to evaluate the efficacy of an intervention designed to reduce STI/HIV~     incidence by increasing the number of adolescent mothers who re-enroll and remain in school.~     The objective of the intervention is to have older mentor mothers, who themselves were~     pregnant adolescents, to mentor younger adolescent mothers. Mentor mothers will provide~     ongoing psychosocial support, help navigate re-admission to school, and help facilitate~     access to an existing State-sponsored cash transfer, the child support grant (CSG), in the~     early postpartum period. Our combination social protection program will enhance resilience of~     young adolescent mothers to facilitate their return to school and thereby reduce HIV risk.~     The investigators will evaluate the efficacy of the intervention using a pre-test post-test~     randomized controlled trial design. Participants in the intervention will receive the~     Mentoring Adolescent Mothers At School (MAMAS) intervention and standard postpartum care.~     Those in the control arm will receive standard postpartum care. Additionally, for those~     participants randomized to the intervention arm, mentor mothers will use participatory visual~     methods (e.g., photovoice, cell-films, drawings) as part of the intervention itself. Last,~     among those participants randomized to the intervention arm and who return for their 9-month~     assessment, the investigators will conduct 20 in-depth interviews to understand the process~     of resilience development from their perspective.~      Primary outcomes:~      School outcomes (initial outcomes) HYP 1.1: Program participation will increase school~     enrollment HYP 1.2: Program participation will increase school engagement~      HIV risk outcomes (intermediate outcomes) HYP 2.1: Program participation will reduce number~     of sexual partners HYP 2.2: Program participation will reduce inconsistent condom use HYP~     2.3: Program participation will reduce intimate partner violence HYP 2.4: Program~     participation will decrease HIV/STI infection HYP 2.5 (for HIV+): Program participation will~     increase retention in care~      Secondary outcomes:~      HYP 5: Program participation will increase peer support HYP 6: Program participation will~     increase familial support HYP 7: Program participation will increase school re-admission HYP~     8: Program participation will increase application to the child support grant HYP 9: Program~     participation will increase receipt of the child support grant~   "
36352|NCT03090789|"~     This multicenter natural history study aims to expand the network of clinical research~     centers in FA, and to provide a framework for facilitating therapeutic interventions. In~     addition, this study will lead to the development of valid yet sensitive clinical measures~     crucial to outcome assessment of patients with Friedreich's Ataxia. This study will support~     genetic modifier studies, biomarker studies, and frataxin protein level assessments by~     building a sample repository.~   "
36353|NCT03090776|"~     Aim 1: To determine the effectiveness of perioperatively administered ketamine to decrease~     acute and persistent postmastectomy pain (PPMP).~      Hypothesis 1.1: Patients undergoing partial or total mastectomy treated with a bolus and~     perioperative infusion of the NMDA-receptor antagonist ketamine will have decreased~     postoperative pain and opioid utilization compared to those receiving saline control.~      Hypothesis 1.2: Patients undergoing partial or total mastectomy treated with a bolus and~     perioperative infusion of the NMDA-receptor antagonist ketamine will have decreased~     persistent postoperative pain measured at one year after surgery.~      Aim 2: To determine whether there is increased power to detect therapeutic effectiveness in~     an interventional preventive trial, by enrichment with patients at high risk of PPMP.~      Hypothesis 2.1: Ketamine will have a greater analgesic and opioid sparing effect on pain~     scores in high-risk patients than non-high risk patients, compared to placebo.~      Hypothesis 2.2: Ketamine will have a greater preventive effect on pain burden scores at one~     year after surgery in high-risk patients than non-high risk patients, compared to placebo.~   "
36354|NCT03090763|"~     The objective of this study is to establish whether patients with aortic aneurysm, compared~     to general population, have higher levels of selected miRNAs and whether there is significant~     association between the level of miRNA in circulating blood and the size of the aortic~     aneurysm or the risk of its rupture.~   "
36355|NCT03090750|"~     The purpose of this study is to see if using aromatherapy (Lavender or Bergamot) will lower~     anxiety in patients having invasive Radiology procedures. First, the level of anxiety is~     assessed prior to the procedure using a questionnaire. Then, patients are given the~     aromatherapy treatment during the pre-procedure period. Then, the same questions are asked to~     determine how anxious the patient is after the aromatherapy and before going into the~     procedure room. After the procedure, patients are asked to evaluate the process of the study.~   "
36356|NCT03090737|"~     A study to evaluate the safety of Nivolumab in patients with advanced or metastatic non-small~     cell lung cancer~   "
36357|NCT03090724|"~     The purpose of this study was to assess the effects of age on the pharmacokinetic (PK)~     profile of BIA 5-453 and its metabolites.~   "
36358|NCT03090711|"~     Brain functions are supported by multiple cell types, including neuronal and non-neuronal~     cells that are connected into complex networks. When the connectivity between those cells is~     altered or disrupted, the functioning of the brain is impaired. In stroke, the interruption~     of blood supply to the neural circuits results in connectivity damage and permanent~     disabilities. Experimental evidence suggests that some types of brain state, including sleep,~     can protect brain tissue from stroke and repair the damaged circuits. This project will~     investigate the neuronal mechanism underlying the protective effect of sleep on brain~     connectivity and network activity. To this end, the investigators will use a collection of~     state-of-the-art technologies including high-density electroencephalography (hd-EEG),~     transcranial magnetic stimulation (TMS) and transcranial alternating current stimulation~     (tACS). Perspectives include a better understanding of the causes and consequences of the~     perturbed electrical activity of the brain during sleep in stroke patients.~   "
36359|NCT03090698|"~     A comparison of intraarticular administration of Hylan GF20, Triamcinolone and both~     associated in patients with severe osteoarthritis of the knee with follow up of one, three~     and six months.~   "
36361|NCT03090672|"~     Musculoskeletal disorders and degeneration represent injuries or pain in the body's joint~     ligaments, tendons, muscles, nerves, and skeletal elements that support extremities, spine~     and related tissues. Direct injuries and aging contribute to breakdown and inflammation of~     these tissues, leading to debilitation and loss of function in these areas. This has major~     impact on quality of life, occupational/recreation limitations, and psychosocial~     implications.~      Many therapies have been employed including medications, physical therapy, occupational~     therapy, and a variety of surgical interventions each of which have distinct limitations,~     often covering the issues versus providing actual healing and return to function. Many~     reports are now available utilizing self-healing options which include use of stem/stromal~     cellular therapy or biocellular treatments (either from adipose or marrow) using targeted~     placement of cells, matrix and platelet concentrates. Termed cellular or Biocellular therapy~     (typically optimized using ultrasound guidance). It is proposed that use of cellular isolates~     or cell-stroma derived from the largest deposit of these cells (adipose greater than marrow),~     may use in conjunction with targeted placement or as a stand alone methodology intravascular~     use.~      This study is designed as a interventional means to examine the safety and efficacy of the~     use of cellular and tissue stromal vascular fraction in musculoskeletal pain, dysfunction~     degeneration or inflammatory disorders.~   "
36362|NCT03090659|"~     This is a single arm, open-label, multi-center, phase 1/2 study, to determine the safety and~     efficacy of LCAR-B38M CAR-T cells in treating patients diagnosed with refractory/relapsed~     multiple myeloma (r/r MM).~   "
36363|NCT03090646|"~     The investigators are interested in whether or not the use of a small financial incentive~     (gift card) increases the rate of follow-up compliance among live kidney donors. The~     investigators aim to test this by randomly assigning live kidney donors to the intervention~     (gift card at time of follow-up visit) or control arm (standard of care) upon discharge from~     their initial kidney donation hospitalization, and tracking follow-up compliance over time.~     The study population will be approximately 320 live kidney donors who undergo donor~     nephrectomy at Johns Hopkins Hospital (80/year for 4 years).~   "
36364|NCT03090633|"~     The purpose of this investigation is to evaluate maternal and fetal outcomes following~     fetoscopic repair of fetal spina bifida at the Johns Hopkins Hospital.~      The hypothesis of this study is that fetoscopic spina bifida repair is feasible and has the~     same effectiveness as open repair of fetal spina bifida, but with the benefit of~     significantly lower maternal and fetal complication rates. The fetal benefit of the procedure~     will be the prenatal repair of spina bifida. The maternal benefit of fetoscopic spina bifida~     repair will be the avoidance of a large uterine incision. This type of incision increases the~     risk of uterine rupture and requires that all future deliveries are by cesarean section. The~     use of the minimally invasive fetoscopic surgical technique may also lower the risk of~     preterm premature rupture of membranes and preterm birth compared to open fetal surgery.~     Finally, successful fetoscopic spina bifida repair also makes vaginal delivery possible.~   "
36365|NCT03090620|"~     Overdose of xenobiotics (antihistamines, antipsychotics, or Jimson Weed) with resulting~     antimuscarinic toxidrome is a common scenario in medical toxicology. The result of antagonism~     of muscarinic receptors is a constellation of signs and symptoms (toxidrome): mydriasis,~     decreased sweat, decreased bowel sounds, agitation, delirium, hallucinations, urinary~     retention, tachycardia, flushed skin and seizures. Two treatment options are physostigmine or~     benzodiazepines.~      Although the antimuscarinic toxidrome occurs commonly, physostigmine has been used sparingly~     despite evidence of safety and efficacy. To demonstrate the utility and safety of~     physostigmine, the investigators propose a randomized clinical trial of physostigmine~     compared to benzodiazepine for antimuscarinic toxicity.~   "
36366|NCT03090607|"~     This is a prospective, multi-center, double-blind randomized controlled trial designed to~     demonstrate the safety and efficacy of Aluvra for the treatment of GERD.~   "
36367|NCT03090594|"~     Cryobiopsy has displaced the transbronchial biopsy (BTB) with forceps because it allows to~     obtain samples of more representative pulmonary parenchyma with more alveoli, less artifacts~     and a greater diagnostic yield. However, some authors report an increase in adverse effects~     such as hemorrhage and pneumothorax. The latest ISHLT (International Society for Heart and~     Lung Transplantation) consensus of 2007 recommends that with BTB with forceps a minimum of~     five tissue samples should be obtained that should contain more than 100 wells or the~     presence of two bronchioles to Which may be necessary between 3 and 17 samples. The optimal~     number of transbronchial cryobiopsies is unknown in order to obtain maximum performance with~     the lowest possible morbidity.~      It is proposed to analyze the morphological and histopathological characteristics of each~     cryobiopsies individually and in order of extraction, to determine the sensitivity in the~     diagnosis of acute rejection as a function of the number of samples. Lung transplant~     patients, not admitted to critical units, with BTB indication will be included. A maximum of~     6 samples will be obtained by flexible bronchoscope and under general anesthesia.~      These data will allow to know the minimum number of specimens that guarantee a histological~     and / or bacteriological diagnosis of certainty with maximum effectiveness.~   "
36368|NCT03090581|"~     The survival of lung transplant patients (PD) is limited mainly by Infections, graft~     dysfunction in the immediate postoperative period and chronic dysfunction. Up to 36% have an~     episode of acute rejection after transplantation. For the diagnosis of these pathologies,~     transbronchial lung biopsy (BPTB) is essential. The classical method is the realization of~     BPTB with conventional clamp, but the performance diagnosis is limited. However, the use of~     cryoprobes for sampling in other pulmonary pathologies have been shown to achieve a higher~     diagnostic yield. The BPTB performance is variable and depends on factors such as sample size~     and the presence of artifacts (crushing) produced by the forceps tweezers. The objective~     principal is to compare the diagnostic yield of samples obtained with cryoprobe compared to~     those obtained with conventional biopsy tweezers. A prospective, randomized, and comparative~     study is proposed for all patients in the intensive care unit after lung transplantation in a~     24-month period, at Vall de Hebron Hospital. Patients will be divided into two groups:~     symptomatic and asymptomatic. The exclusion criteria are the contraindications of the~     procedure and the factors which increase the hemorrhagic risk. A flexible bronchoscope~     (BF-18BS) will be used and the procedure will be performed according to the technique~     conventional. The patient undergoing the procedure will be intubated, sedated and relaxed~     under supervision and continuous monitoring by an intensivist. A bronchoalveolar lavage and a~     maximum of 6 samples will be obtained. Morphological study (middle area, artifacts,~     components, diagnosis), microbiological, histological and anatomopathological according to~     the usual protocol. The duration of the procedure, the complications and the frequency with~     which the diagnosis obtained after the procedure modifies the therapeutic behavior will be~     monitored. These data will allow to evaluate the potential benefits of this procedure in the~     diagnosis of pulmonary pathology in lung transplantation.~   "
36369|NCT03090568|"~     The purpose of this study was to compare the bioavailability and tolerability of BIA 5-453~     under fasted and fed conditions.~   "
36370|NCT03090555|"~     This study evaluates the addition of translational manipulation under interscalene block, to~     a course of orthopaedic manual physical therapy for treatment of adhesive capsulitis of the~     shoulder. Half the patients will receive a translational manipulation under interscalene~     block, plus 6 sessions of orthopaedic manual physical therapy. The other half will receive 7~     sessions of physical therapy. The investigators hypothesize that the translational~     manipulation under interscalene block will provide additional benefit beyond the effect of~     in-clinic orthopaedic manual physical therapy alone.~   "
36371|NCT03090542|"~     In healthy subjects not receiving or requiring lipid lowering therapy and who do not have~     diabetes, the use of clinoptilolite (GPUR) will result in a reduction of absorbed dietary~     cholesterol observed over 6 days of therapy.~   "
36372|NCT03090529|"~     The main purpose of this study is to assess whether exercise training reduces ambulatory~     blood pressure in patients with resistant hypertension. To accomplish these goals 60 patients~     with resistant hypertension will be recruited and randomized into exercise training or~     control groups and followed up for 6 months. The patients in the exercise group will~     participate in a 3-month outpatient program. The control group will receive usual medical~     care. At baseline, after the intervention and 3 months after the end of the intervention both~     groups will undergo several evaluations, including casual and ambulatory blood pressure, body~     composition, cardiorespiratory fitness, quality of life, arterial stiffness, autonomic~     function, and endothelial and inflammatory biomarkers.~   "
36373|NCT03090516|"~     This project explores Ginkgo biloba ester dispersible tablets influence on cognitive function~     in patients with mild-to-moderate elderly, to observe the effects of different intervention~     time on cognitive function, for alzheimer's patients in drug rehabilitation treatment~     provides an effective solution.~   "
36374|NCT03090503|"~     This study compares the efficacy and effectiveness of two of the second-generation~     antipsychotics (SGAs) most used in our society in the treatment of schizophrenia~     (Aripiprazole and Risperidone) and the investigators do within an assistance program of~     early-stage psychosis individuals of the Community of Cantabria, clinical reference for the~     treatment of this disease in the Spanish Autonomous Community. Patients are included in a~     prospective naturalistic study, open flexible-doses and randomized into one of two possible~     patterns of treatment that includes the protocol.~   "
36375|NCT03090490|"~     This open-label, non-randomized, prospective study will evaluate the risk of symptoms~     recurrence during the ten years after antipsychotic discontinuation in a sample of~     functionally recovered first-episode patients with schizophrenia spectrum disorder.~   "
36376|NCT03090477|"~     Owing to effective treatment with tyrosine kinase inhibitors (TKIs), chronic myeloid leukemia~     (CML) has become a chronic disease with a rising prevalence globally. Although the~     possibility of stopping TKI therapy in CML patients who have achieved deep molecular~     responses is a topic of active debate and investigation, life-long treatment remains the~     current standard of care. It has been estimated that 3% to 56% of CML patients are not~     adherent to their prescribed TKI therapy. Poor adherence to TKIs could compromise the control~     of CML, and contributes to poorer survival. CML patients on long-term TKI therapy are prone~     to developing certain medication-related issues such as adverse reactions and drug~     interactions.Occurrence of adverse reactions even at low grades, has been shown to impact CML~     patient's health-related quality of life (HRQoL) and adherence to treatment. However, there~     is no prospective high quality evidence showing adherence to TKIs and the associated clinical~     outcomes can be improved in CML patients. Therefore, the investigators hypothesize that~     medication management intervention by pharmacist might improve adherence to TKIs, and~     translate into better disease response and HRQoL in CML patients, when compared to control~     arm who receive standard pharmacy service.~   "
36377|NCT03090464|"~     Type 2 diabetes mellitus is a complex, chronic disease that requires a comprehensive~     treatment plan aimed at meeting multitude therapeutic targets associated with micro- and~     macro-vascular risk reduction. There is evidence that patient support in various forms can~     have a significant positive impact on adherence to treatment and the meeting of targets in~     patients with type 2 diabetes mellitus. The purpose of this study is to evaluate if the use~     of a digital disease management tool (Smart phone- web portal-based tool), in addition to~     Standard of Care for T2DM, will improve glycemic control. Other variables important in T2DM~     (such as weight, blood pressure, and lipid levels), will also be evaluated along with~     patient-reported outcomes, such as satisfaction with treatment and adherence to their~     antihyperglycemic treatment. Study duration is 6 months~   "
36378|NCT03090451|"~     People with type 1 diabetes often find exercise very difficult to manage, because of the high~     risk for low blood glucose levels. This can occur very quickly once exercise starts and~     presents many risks for subjects, such as severe symptoms, confusion, passing out, seizures,~     and even coma or death in very severe cases. Preventing low blood glucose levels during and~     after exercise is important because physical exercise is a key component of managing~     diabetes. It is often hard to correctly adjust insulin infusion rates or doses before~     exercise as the relationship between exercise and changes in glucose levels in those who have~     type 1 diabetes is still not fully understood. Therefore, the investigators propose this~     study to further our understanding in this area.~      This study is designed to help separate the effects of insulin from those of muscle work~     (non-insulin effects) on the changes in blood glucose levels during aerobic exercise. The~     main hypothesis is that the non-insulin effects occur quickly during exercise and account for~     the rapid change in blood glucose levels once aerobic exercise begins. These effects can be~     separated from the slower changes in insulin sensitivity that occur because of exercise, and~     which account for reduced insulin demand even after exercise has stopped. The investigators~     will investigate the effects of both moderate and intense aerobic exercise at different~     levels of insulin in the body to help separate the insulin and non-insulin effects.~      The investigators wish to recruit 26 subjects to take part in this study. Subjects will be~     randomly divided into two groups, with 13 in each group. Group 1 will undergo moderate~     aerobic exercise, while group 2 will undergo intense aerobic exercise. Each subject will~     repeat the exercise study three times on three separate days at least 2 weeks apart, while~     having insulin infused at a low, a medium, and a high rate. Subjects will have an IV line~     placed in each arm, one for drawing blood relatively frequently during the study, and another~     for infusion of insulin, glucose, and a special glucose tracer (non-radioactive). Each study~     lasts about 9 hours.~      Information from this study will be used to help develop a mathematical model of how glucose~     changes during exercise in type 1 diabetes. Such a model of type 1 diabetes and exercise will~     be very useful for adjusting insulin doses in patients who use multiple daily injections of~     insulin, and can help to guide an automated insulin delivery system, such as the artificial~     pancreas.~   "
36421|NCT03089879|"~     GVGH Shigella Sonnei 1970GAHB is a vaccine aimed at preventing the disease caused by Shigella~     sonnei.~      A post-hoc analysis of subjects who participated in the parent study showed significantly~     different responses in subjects with detectable versus undetectable antibody titres at~     baseline, suggesting the possibility that the vaccine might not be sufficiently immunogenic~     in completely naïve adults.~      This study was then designed to further characterize the immunogenicity profile of the~     vaccine and to evaluate whether it was able to induce an immunological memory response.~   "
36379|NCT03090438|"~     Infertility has been estimated to affect from 6-18% of couples trying to conceive. In 20-30%~     of cases, the problem is with the male. Varicocele is a common cause of male factor~     infertility (MFI) being responsible for 30-35 % of primary and 69-81 % of secondary MFI.~     Varicocele repair has been shown to improve sperm parameters and increase natural pregnancy~     rates and the results of assisted reproductive techniques (ART).~      There are two possible treatment pathways for varicocele associated male factor infertility.~     1) standard IVF/ICSI 2) varicocele repair followed by IVF/ICSI if there is no spontaneous~     pregnancy. There is however no consensus as to which pathway is preferable and no randomized~     comparative studies have been carried out.~      IVF/ICSI is a standard treatment for infertility but frequently requires repeated treatments~     to achieve a live birth. The purpose of this study is to determine if the improved sperm~     parameters caused by prior treatment of the varicocele will result in improvements both in~     overall pregnancy/birth rates and in IVF/ICSI results.~   "
36380|NCT03090425|"~     In a hitherto ill-defined proportion of patients with inflammatory/familial cardiomyopathy,~     the phenotype dilative cardiomyopathy (DCM) is assumed to be the endstage of a multifactorial~     etiopathogenetic pathophysiology. Precipitating factors include enhanced autoimmunity,~     predisposition for viral infections, environmental factors in addition to a specific 'genetic~     background' of the individual patient. It is unresolved, whether the susceptibility to~     immunologically mediated myocardial damage reflects the presence of genetic risk factors~     shared by other autoimmune diseases, or is cardio-specific with individual predisposing~     factors. Aims of the project are the search for a genetic link or oredisposition to~     autoimmune diseases in patients with familial / inflammatory DCM.~   "
36381|NCT03090412|"~     This randomized phase II clinical trial studies how well photodynamic therapy with HPPH works~     compared to standard of care surgery in treating patients with oral cavity cancer.~     Photodynamic therapy can destroy or control disease by using a combination of drug, such as~     HPPH, and light and may be as effective as surgery in treating patients with oral cavity~     cancer.~   "
36382|NCT03090399|"~     In this retrospective analysis investigators will study the effects of using a minimally~     invasive hemodynamic monitoring (FloTrac-Edwards) on postoperative outcomes. Participants~     will compare a control group to a case group; in both groups ASA 1 patients suffering from~     advanced ovarian cancer underwent radical cytoreductive surgery. In case group hemodynamic~     was managed by using the FloTrac system; in the control group a standard hemodynamic~     monitoring was used.~   "
36383|NCT03090386|"~     This study is to evaluate which cognitive-linguistic symptoms are most commonly experienced~     following brain tumor treatment. Cognitive surveys will be administered after treatment of~     primary brain tumor cancer.~   "
36384|NCT03090373|"~     This is a double blinded rct to evaluate the effect of the UroShield SAW transducer on~     preventing bacterial colonization in longterm indwelling catheters. The duration of the trial~     is 30 days. The investigator will be quantifying the number of bacterial colonies in the~     urinary catheter and in the bladder in both the treatment and control group.~   "
36385|NCT03090360|"~     To evaluate the growth of healthy term infants fed an experimental infant formula with a~     prebiotic, a commercial control infant formula with a probiotic, but without a prebiotic and~     human breast milk~   "
36386|NCT03090347|"~     In health,adipose tissue stores fat from the diet. If the fat tissue stops storing dietary~     fat then this increases the chance of it being stored in the liver, which is related to~     increased risk of heart disease and type 2 diabetes. It has been suggested that having a diet~     high in sugars or certain fats, may cause the fat tissue and liver to change how they~     function; we would like to investigate this in detail.~   "
36387|NCT03090334|"~     This is a multicenter, prospective, open-label, randomized trial. Patients with severe~     abdominal condition developing severe sepsis or septic shock and receiving broad spectrum~     antibiotic and antifungal treatment will be randomized (1:1) to:~        1. discontinue antifungal treatment based on negative (<80 pg/ml) result of 1,3~          beta-d-glucan performed on day 0,3,6 and 10~        2. continue antifungal treatment according with attending physician's decision.~   "
36388|NCT03090321|"~     The MyHeart Counts Cardiovascular Health Study will utilize mobile health capabilities of~     smartphones and wearables to assess daily activity measures of the general population and~     compare these to measures of cardiovascular health risk factors and fitness. How people~     divide their time among exercise, sedentary behavior, and sleep all affect cardiovascular~     health, yet to date these have largely gone unmeasured. With the advancement of phone sensors~     and wearable fitness tracking devices these factors are now more straightforward to gather~     and measure. The use of smartphones by a large segment of the population allows for data~     collection on an unprecedented scale. The investigators aim to amass activity and~     cardiovascular health data on thousands of participants as well as provide significantly more~     quantitative data on type,duration, and intensity of daily activities.~      In the second phase of the MyHeart Counts Cardiovascular Health Study (Randomized Assessment~     of Physical Activity Prompts In A Large Ambulatory Population) the researchers will conduct a~     randomized controlled clinical trial of four different physical activity prompts~     (intervention) and their effect on the level of physical activity in the study population as~     measured by change in step count.~   "
36389|NCT03090308|"~     The study included 20 adult patients presented by multiple fractured ribs (flail segment)~     with thoracic trauma severity score (TTSS) between 5 and 15. All patients received~     mid-thoracic epidural analgesia with 0.125% Bupivacaine and 1 μg/ml fentanyl. The patients~     were ventilated using non-invasive positive pressure ventilation (NIPPV). Follow up arterial~     blood gases, chest X-ray and CT scan were obtained. Parameters to be recorded: Patient's~     characteristics and clinical data including pulmonary contusion, number of fractured ribs,~     pleural involvement, PaO2/FiO2 ratio on admission, weaning outcome, duration of NIPPV, length~     of stay in ICU (LOS ICU), complications and mortality rate.~   "
36462|NCT03089346|"~     Bronchial remodeling is a major pathological feature of asthma. Non-invasive assessment of~     this bronchial remodeling is a crucial issue for asthma patients' follow-up. Currently,~     computed tomography (CT) is the method of reference to evaluate and quantify bronchial~     thickness but it remains unable to differentiate bronchial inflammation from remodelling and~     is a radiation-based technique. Magnetic Resonance Imaging (MRI) with Ultrashort Echo Time~     (UTE) pulse sequences is a promising non-ionizing alternative for lung imaging. Our objective~     is to evaluate bronchial thickness in asthma patients using CT and MRI-UTE, and to test the~     agreement between both techniques.~   "
36390|NCT03090295|"~     The Accuro is a three dimensional handheld ultrasound device. This device uses sound waves to~     create pictures of the spine in three dimensions. This may allow the physician to view the~     spine in more detail for procedures such as spinal anesthesia and other diagnostic~     procedures.~      We aim to assess the benefit of using both the Accuro and traditional landmark palpation~     technique to determine accurate spinal level in women who undergo cesarean section. This~     study will also assess provider preference for use of both Accuro and palpation compared with~     palpation alone or use of Accuro alone.~      Anesthesia Providers will first identify the L4/L5 space using the traditional technique of~     palpating the iliac crests to estimate spinal level, which will be marked with a single dot~     from a marking pen. The provider will then use the Accuro 3000 to identify the L4/L5~     interspace.~      Results will be compared to results obtained in IRB 18070 Handheld 3D lumbar spine~     navigation: A clinical validation study RM002 where subjects who were undergoing a C-section~     were randomized to either palpation or Accuro alone.~   "
36391|NCT03090282|"~     The investigators planed to observe the microbiome of an aggressive periodontitis patient,~     during mechanical treatment, surgery(if indicated) and implant placement. The investigators~     designed to observe the changes after mechanical treatment.Then, the investigators will~     compare the sub-mucosa microbiome of implant and the subgingival community. The investigators~     expected a different community after treatment, and there could be similarity between implant~     and nature teeth.~   "
36392|NCT03090269|"~     This phase II pilot study aims at evaluating the benefits and the risks of methylphenidate~     (Concerta®) for the treatment of cocaine/crack dependence in terms of cocaine/crack use~     reduction and adverse events.~   "
36393|NCT03090243|"~     Our trial examined the intraocular pressure measurements differences, before and after~     virtual colonoscopy examination.~   "
36394|NCT03090230|"~     The purpose of this study is to investigate the safety and effectiveness of the RelayPro~     Thoracic Stent-Grafts in subjects with traumatic injury of the descending thoracic aorta~     (DTA)~   "
36395|NCT03090217|"~     Vaginal stenosis is one of the most prevalent side effects of pelvic radiation, affecting~     about one third of women. In this randomized controlled trial, the effect of a pelvic~     physiotherapy protocol on an incidence rate of vaginal stenosis in women with gynecological~     cancer undergoing gynecological brachytherapy. In addition, the investigators will explore an~     improvement in quality of life, sexuality, and contractile function of the pelvic floor~     muscles.~   "
36396|NCT03090204|"~     The analysis of the systolic function (contractility) of the right ventricle (RV) is~     fundamental and central in many pathologies in intensive care unit. It can guide physicians~     in choosing therapeutics. The conventional ultrasound markers of RV function evaluation~     currently used are influenced by RV loading conditions, impairing their capacity to~     approximate a true contractility analysis. Myocardial strain imaging is a recent echographic~     technique that allows, among other things, to evaluate RV systolic function. It is a~     reproducible index with early variations which, if it proved to be independent pre-load,~     would help to better appreciate the RV contractility.~   "
36397|NCT03090191|"~     The Clover trial is evaluating an investigational vaccine that may help to prevent~     Clostridium difficile infection. Participants in the study are adults 50 years of age and~     older, who are at risk of developing Clostridium difficile infection. The study will assess~     whether the vaccine prevents the disease, and whether it is safe and well tolerated.~      Each subject will receive 3 doses of Clostridium difficile vaccine or placebo and be followed~     for up to 3 years after vaccination for potential Clostridium difficile infection.~   "
36398|NCT03090178|"~     Atopic dermatitis is a chronic disease with a high impact on patient's quality of life.~     Nocturnal pruritus is one of the main symptoms affecting quality of life. Treatment efficacy~     is generally measured by healthcare professionals during consultations with both questioning~     and visual examination of the lesions. Quality of Life (QoL) can also be evaluated~     retrospectively with the Dermatology Life Quality Index (DLQI) scale. Collecting data~     retrospectively introduces a significant recall bias that can be addressed by collecting data~     in Real World (RW). Real World data collection is prospective and take place within the~     patient's own environment. While data collection is generally done with diaries, it has been~     demonstrated that smartphone and connected devices were able to produce more precise and~     granular data than traditional methods.~   "
36399|NCT03090165|"~     This is an open label, multi-institutional, single arm phase II trial of ribociclib in~     combination with bicalutamide in advanced AR+ triple-negative breast cancer. No randomization~     or blinding is involved.~   "
36400|NCT03090152|"~     Total hip arthroplasty can be associated with significant postoperative pain. Side effects of~     pain management may impair participation in physical therapy and slow readiness for discharge~     from the hospital. In a previous study done by the investigators' group, epidural patient~     controlled analgesia (EPCA) with a hydromorphone containing solution appeared to have a more~     favorable pain profile with ambulation, but greater side effects compared to injection of a~     peri-articular cocktail. The use of opioid was greater in the peri-articular injection group~     (PAI). There was no difference in length of stay. In view of the controversy over opioid use,~     the investigators would like to develop an optimal opioid sparing pain management approach by~     comparing 3 different protocols 1) Plain local anesthetic EPCA; 2) PAI; 3) EPCA + PAI; all in~     conjunction with a multimodal opioid sparing pain regimen. The goal would be to maximize pain~     control while minimizing opioid use and side-effects.~   "
36401|NCT03090139|"~     The purpose of this study is to establish the incidence of sub-optimal response to anti-TNF~     therapy in UC and CD participants.~   "
36402|NCT03090126|"~     The purpose of the study is to assess the therapeutic education of patients with chronic~     respiratory failure who start to be treated with non invasive ventilation and during the~     first six months of ventilation.~   "
36403|NCT03090113|"~     This is a randomized, double blind, placebo-controlled, parallel, multicenter research in~     order to evaluate the effect of Shuxuetong injection in prevention of symptomatic or~     asymptomatic new cerebral infarction within 10 days.~      Subgroup study：Evaluate the role of advanced diagnostic technique in identifying potential~     causes of Embolic Stroke of Undetermined Source (ESUS).~   "
36404|NCT03090100|"~     The purpose of this study is to evaluate the efficacy of guselkumab compared with secukinumab~     for the treatment of participants with moderate to severe plaque-type psoriasis.~   "
36405|NCT03090087|"~     The purpose is to investigate how the adenosine affects the diameter regulation of retinal~     arterioles during changes in oxygen tension. A deeper understanding of the mechanisms~     involved in diameter regulation of retinal arterioles during changes in oxygen tension can be~     used to obtain a more detailed understanding of diseases where changes in the diameter~     regulation of retinal vessels are involved in the disease pathogenesis and possibly point to~     new therapeutic options for patients with retinal vascular disease, such as diabetic~     retinopathy and retinal vein thrombosis.~      Preliminary, a routine ophthalmological evaluation, measurement of blood pressure, and~     electrocardiogram will be preformed to insure that only healthy test persons are included in~     the study.~      The test persons will be randomly allocated to two groups, one group in which protocol 1 is~     followed by protocol 2, and the other group with the two protocols performed in the reverse~     order.~      Protocol 1: Using the DVA, a video recording will capture the diameter of retinal vessels and~     the changes occurring during stimulation with flickering light. The recording lasts 4.5~     minutes and is preformed before and after intravenous injection of adenosine.~      Protocol 2: The procedures are similar to those of protocol 1 but are performed during~     breathing of a gas mixture with a reduced oxygen tension to 12,5 %, which results in a~     reduced oxygen saturation in the blood to 85-90 %.~   "
36406|NCT03090074|"~     Risk-patients for diabetes or patients that are diagnosed with this condition but who are not~     treated with insulin are randomized two times, according to diet and according to the type of~     support:~      Randomization with regard to carbohydrate restriction (25-30 E% or < 10E%). Randomization~     with regard to type of psychological support. Either according to Acceptance and Commitment~     Therapy or to traditional cognitive behavioral therapy. Both kinds of psychological support~     is given as group therapy.~      Two-hundred patients are recruited and each patient is followed for two years.~   "
36407|NCT03090061|"~     This study will be conducted to assess diagnostic predictive values of a light induced~     fluorescence intraoral camera versus those of the visual-tactile assessment method according~     to FDI criteria in clinical evaluation the margins of resin composite restorations~   "
36408|NCT03090048|"~     Patients seen with acne lesions not having responded to existing treatments will be offered a~     placebo or a topical preparation consisting of Vitamin A USP with or without Azithromycin for~     a duration of 4-6 months USP for the objective of resolving the lesions without systemic side~     effects and via weekly follow-ups.~   "
36409|NCT03090035|"~     Objective:~      Pegulated Interferon α2 plus ribavirin is a treatment of choice in patients with chronic~     hepatitis C infection. This study was conducted to find out the frequency of different IL-28B~     (rs12979860) genotypes in patients with chronic hepatitis C (HCV genotype type 2 & 3)~     infection treated with Pegulated Interferon α2 plus ribavirin and to evaluate the role of~     IL-28B genotypes in achieving Sustained Virological Response (SVR).~      Methods:~      In this non-randomized observational study, ninety eight (98) patients with diagnosis of~     chronic hepatitis C were included. In all patients, Peg-IFN plus Ribavirin were given in~     standard doses for 24 weeks. End treatment response, sustained virological response, and~     relapse rate were the primary endpoints of this study. Analysis of IL28B (rs12979860)~     polymorphism (CC, CT and TT) was performed by PCR-RFLP protocol.~   "
36410|NCT03090022|"~     Incisional hernia is a common complication in visceral surgery and varies between 11 and 26%~     in the general surgical population. Patients requiring emergency laparotomy are at high risk~     for the development of incisional hernia and fascial dehiscence. Among this population the~     incidence of incisional hernia in patients undergoing emergency surgery varies between~     33-54%. Incisional hernias are associated with a high morbidity rate, such as intestinal~     incarceration, chronic discomfort, pain, and reoperation and typically require implantation~     of a synthetic mesh in a later second operation. Fascial dehiscence represents an acute form~     of dehiscence and has been observed in up to 24.1% and is associated with a mortality rate up~     to 44%.~      The gold standard for abdominal wall closure during elective and emergency operations is a~     running slowly absorbable suture. In the elective situation it has been shown that~     prophylactic mesh implantation in high risk patients reduced the incidence of incisional~     hernia significantly.~      The investigators and others have shown that mesh implantation in patients undergoing~     emergency laparotomy or in contaminated abdominal cavities are safe .~      With a randomized controlled trial the investigators now aim to compare the incidence of~     incisional hernia after prophylactic mesh implantation versus standard of care in patients~     requiring emergency laparotomy.~   "
36411|NCT03090009|"~     Dental implants are often used to replace missing teeth. In fact, in the US over 700,000~     implants are places every year and over 2 million implants are places world wide.~     Peri-implant mucositis in an inflammatory condition affecting dental implants and is~     recognized as a risk factor for peri-implantitis (a condition affecting the bone around~     implants and eventually leading to implant loss). The prevalence of Peri-implant Mucositis~     has been reported in the literature to range from 50-90% whereas the prevalence of~     Peri-implantitis has been reported as high as 20%. it is commonly believed that a dysbiotic~     microbiome is the primary cause for these conditions.~      The inflammatory burden around diseased implants creates a high-protein environment which is~     necessary for the survival of pathogenic bacteria. It is logical, therefore, that reducing~     inflammation by Non Steroidal Anti-Inflammatory Drugs (NSAIDs) may create a shift in the~     dysbiotic microbiome to a symbiotic microbiome. The aim of the current study is to test the~     effects of oral NSAIDs on the peri-implant microbiome.~   "
36412|NCT03089996|"~     This study will compare the techniques of piezocision and alveolar corticotomies in~     accelerating orthodontic tooth movement. It will consist of a split-mouth study in patients~     who require the extraction of the first premolars to correct malocclusion. The canine will be~     retracted using these surgical techniques, as well as without any intervention, being this~     the control side. In addition, will be evaluated the inflammatory biomarkers present in the~     gingival crevicular sulcus during the dental movement, as well as data related to pain and~     discomfort.~   "
36463|NCT03089333|"~     New strategies trying to achieve blood pressure control and consequently reduce~     cardiovascular risk in resistant hypertensive subjects are promising. In this context, the~     SGLT2 inhibitor dapagliflozin, not yet investigated in resistant hypertension, arises as a~     potential drug in order to impact on blood pressure levels, as well as target organ damage~     and adiposity in this high-risk population.~   "
36413|NCT03089983|"~     The purpose of this study is to conduct empiric studies of tuberculosis (TB) among prison~     inmates with a history of opioid dependence. This includes: a) comprehensive TB diagnostic~     study (symptom screening, chest x-ray, tuberculin skin test, acid-fast bacilli smear, Gene~     Xpert, and sputum culture) to determine best practices for screening HIV+ and HIV- prisoners;~     b) A RCT of latent TB infection prevention strategies among HIV+ and HIV- prisoners with high~     prevalence of hepatitis C (HCV) using standard 40-week daily isoniazid (40H) vs short-course~     weekly isoniazid + rifapentine (12HR); and c) a 3-arm preference trial comparing post-release~     TB treatment completion in patients on opioid agonist treatment (methadone vs naltrexone~     implant) vs no opioid agonist treatment in patients being treated for active or latent TB who~     are transitioning to the community. Investigators will also use this data, and publicly~     available data to complete agent-based modeling for comparative and cost-effectiveness of~     various TB screening and treatment strategies among prisoners, and upon community transition~     post-release from prison.~   "
36414|NCT03089970|"~     Respiratory virus infections cause a majority of asthma exacerbations in the fall to spring~     months. Current diagnostic platforms for respiratory viruses have limitations including cost,~     availability, and invasiveness. The use of noninvasive breath collection to analyze breath~     metabolites may be used to differentiate virus-infected asthmatics from other causes of acute~     asthma exacerbations.~   "
36415|NCT03089957|"~     Since strategies were applied in intensive care medicine, including low tidal volume~     ventilation, fluid resuscitation, use of antibiotics, restrictive transfusion strategy and~     bundle of ventilator therapy, the incidence of Acute Respiratory Distress Syndrome (ARDS) has~     been decreased recent years. However, the mortality of severe ARDS is still higher to 45%.~     Few medications did were indicated to be effective in working on development of ARDS.~     Different with other disease, ARDS were difficult to prevent in its later stage like a domino~     effect. The medication interventions are all used after ARDS was developed, including~     ulinastatin. The investigators hypothesized that the key point in failure of medication~     therapy is the delay timing of medication intervention. If given the preventive strategy,~     such as ulinastatin, the incidence or the severity of ARDS might be decreased. Therefore this~     is a randomized controlled trial to test the hypothesis of the preventive effect of~     ulinastatin in ARDS.~      This is a multi-center, randomized, double blinded, placebo controlled study.~   "
36416|NCT03089944|"~     A Phase 3b, single arm, open-label, multicenter study to evaluate the safety and to~     demonstrate the non-inferiority of the sustained virologic response 12 weeks post dosing~     (SVR12) rates of 8 weeks of treatment with the glecaprevir (GLE)/pibrentasvir (PIB)~     combination regimen to the historical SVR12 rate of 12 weeks of treatment with the GLE/PIB in~     treatment-naïve adults with chronic HCV GT 1, 2, 4, 5, or 6 infection and compensated~     cirrhosis.~   "
36417|NCT03089931|"~     Low back pain may be reduced after cervical spinal surgery~   "
36418|NCT03089918|"~     The purpose of this study is to investigate the total body biodistribution and radiation~     dosimetry of 11C-JNJ-63779586 by Positron Emission Tomography (PET) in healthy young adult~     males (Part A); to estimate and compare the uptake, distribution, and clearance of~     11C-JNJ-63779586 in the brain by PET between mild Alzheimer Disease (AD) participants~     (males/females) and age- and gender-matched control participants (Part B), corrected for~     regional cerebral blood flow differences; and to model the tissue specific kinetics of~     11C-JNJ-63779586 in human brain with the appropriate input function (IF) (Part B).~   "
36419|NCT03089905|"~     There is considerable evidence that most general anaesthetics modulate brain development in~     animal studies. The impact is greater with longer durations of exposure and in younger~     animals. There is great controversy over whether or not these animal data are relevant to~     human clinical scenarios.~      The changes seen in preclinical studies are greatest with GABA agonists and NMDA antagonists~     such as volatile anaesthetics (eg sevoflurane), propofol, midazolam, ketamine, and nitrous~     oxide. There is less evidence for an effect with opioid (such as remifentanil) or with alpha~     2 agonists (such as dexmedetomidine).~      Some, but not all, human cohort studies show an association between exposure to anaesthesia~     in infancy or early childhood and later changes in cognitive tests, school performance or~     risk of developing neurodevelopmental disorders. The evidence is weak due to possible~     confounding.~      A recent well designed cohort study (the PANDA study) comparing young children that had~     hernia repair to their siblings found no evidence for a difference in a range of detailed~     neuropsychological tests. In that study most children were exposed to up to two hours of~     anaesthesia. The only trial (the GAS trial) has compared children having hernia repair under~     regional or general anesthesia and has found no evidence for a difference in neurodevelopment~     when tested at two years of age. The GAS and PANDA studies confirm the animal data that short~     exposure is unlikely to cause any neurodevelopmental impact.~      The impact of longer exposures is still unknown. In humans the strongest evidence for an~     association between surgery and poor neurodevelopmental outcome is in infants having major~     surgery. However, this is also the group where confounding is most likely.~      The aim of our study is to see if a new combination of anaesthetic drugs results in a better~     long-term developmental outcome than the current standard of care for children having surgery~     lasting at least 2..5 hours.~      Children will be randomised to receive either a low dose~     sevoflurane/remifentanil/dexmedetomidine or standard dose sevoflurane anaesthetic.~      They will receive a neurodevelopmental assessment at 3 years of age to assess global~     cognitive function.~   "
36420|NCT03089892|"~     Chemotherapy is effective and most often used to treat cancer. The common drugs used on~     gynecologic cancer treatment include platinum compounds like cisplatin and carboplatin, which~     combined with taxane, topotecan, or liposomal doxorubicin to date. The most side effects of~     chemotherapy are esophagitis, mucositis, anxiety, nausea, vomiting, abdominal convulsion,~     painful swallowing, fatigue and sometimes diarrhea, dizziness, allergy (rash, itching),~     neutropenia, thrombocytopenia (fever, chills, cough, pain), anemia and bleeding.~      Cancer-related fatigue (CRF), an indicator of quality of life, is a highly prevalent symptom~     (75-80%) during treatment and in patients with advanced cancer, yet is sometimes ignored.~     Fatigue affected their life more than pain. Proposed criteria for CRF have been adopted for~     inclusion in the International Statistical Classification of Disease and Related Health~     Problems, Tenth Revision, Clinical Modification (ICD-10-CM). Therefore, more in-depth~     researches on CRF are needed in Taiwan. Patients with CRF in need of improvement, commonly~     use nutrition supplements, acupuncture, healthy food, massage, drugs, etc. Hence, patients~     with CRF could consult their vital physician for an appropriate treatment. Furthermore,~     several drugs could be chosen to relieve CRF, including anemia drugs, antipsychotics or~     Astragalus polysaccharides extract.~      The objective of this retrospective study is to collect and analyze the medical records of~     gynecologic cancer patients who who had received chemotherapy with or without prescription~     drug treatment for cancer-related fatigue in the Department of Obstetrics & Gynecology of~     Tri-Service General Hospital from December 1st, 2015 to Dec 31st, 2018. This study will~     compare the fatigue improvement profile by different chemotherapy regimens, tumor stage, CRF~     treatment, etc. and investigate the association between the profile of fatigue improvement~     and fatigue cluster (weight loss and other symptoms of functional assessment of cancer~     therapy). This study will also collect blood specimens and analyze the correlation of the~     cytokine profile and/or immune profile.These results will supply physicians with more~     understanding about CRF, and help them to enhance the quality on gynecologic cancer care to~     being perfected in the future.~   "
36464|NCT03089320|"~     The investigators plan to determine the effectiveness of contingency management (CM) plus~     stepped care for unhealthy alcohol use in HIV-positive patients.~   "
36422|NCT03089866|"~     The main goal of this study is to allow the anesthesiologist to make a more informed decision~     about the anesthetic requirement of a person prior to starting anesthesia. The preliminary~     data collected in this study will support a larger investigation aimed at gaining a better~     understanding of anesthetic susceptibility in general and in the elderly population which~     appears to be at greater risk for Postoperative Cognitive Dysfunction (POCD)~      POCD is a short-term decline in cognitive function (especially in memory and executive~     functions) that may last from a few days to a few weeks after surgery. In rare cases, this~     disorder may persist for several months after major surgery. POCD is distinct from emergence~     delirium. It occurs most commonly in older patients and those with pre-existing cognitive~     impairment. POCD is common in adult patients of all ages at hospital discharge after major~     non-cardiac surgery, but only the elderly (aged 60 years or older) are at significant risk~     for long-term cognitive problems. The body's inflammatory response to surgery likely plays an~     important role, at least in elderly patients. Investigators also postulate that a relative~     'anesthetic overdose' may be a significant risk factor. Hence, being able to make a better~     judgment on the dose needed for an individual is extremely important.~   "
36423|NCT03089853|"~     This is a prospective randomized controlled study to test the hypothesis that neuromuscular~     electrical stimulation (NMES) and remote pulmonary rehabilitation at home offered via a smart~     technology, called Smart TeleHealth, results in a reduction of systemic inflammation, via~     reduction of skeletal muscle tissue inflammation, and thereby improves functional capacity,~     and thus, reduces the rate of readmissions following hospitalization for acute exacerbations~     of Chronic Obstructive Pulmonary Disease (COPD). This study will enroll up to 40 participants~     at UAB, about 30 will get Smart Telehealth and NMES, and 10 will get usual care.~   "
36424|NCT03089840|"~     This trial is to assess the safety and efficacy of normothermic machine perfusion (NMP) as an~     organ preservation method prior to transplantation using the OrganOx metra™ device.~   "
36425|NCT03089827|"~     Participants enrolled in the Alzheimer's Disease Clinical Core at Wake Forest School of~     Medicine will be invited to take part in this study. The purpose of this study is to identify~     and measure the amount of a protein called amyloid in the brain.It is thought that the build~     up of amyloid may be related to the development of Alzheimer's disease.~   "
36426|NCT03089814|"~     Changes in tissue microcirculation during ischemic conditioning (4 cycles of 5-min ischemia~     and 5-min reperfusion) has not been well documented. In previous studies, there was~     difference in changes in microcirculation, such as recovery slope and occlusion slope,~     between healthy subjects and cardiac surgery patients. Moreover, the occlusion slope, which~     reflects local tissue oxygen consumption during ischemic period, is anticipated to decrease~     during repeated ischemia-reperfusion cycle by its protecting effect, however there has not~     been well-conducted study. The purpose of the study is to evaluate the changes in~     microcirculation measured by tissue oxygen saturation during ischemic conditioning between~     healthy volunteers and cardiac surgery patients.~   "
36427|NCT03089801|"~     In order to enhance access to clinical and mental health services for Veterans who have~     geographic, clinical, or social barriers to in-person care, VA Offices of Connected Care and~     Rural Health began distributing 5,000 tablets to Veterans with access barriers in 2016. The~     objective of this Quality Improvement evaluation is to:~        1. Understand characteristics of Veterans who received tablets, the frequency and ways in~          which they used the tablets, and the effects of tablet use on access to VA services.~        2. Through a survey of Veterans, evaluate patient experiences using the tablets, and~          determine how tablets influenced patients' experiences with VA care, including their~          satisfaction, communication with providers, and access to needed services.~        3. Identify implementation barriers and facilitators to tablet distribution and use through~          interviews with clinicians and staff in a purposive sample of VA facilities~        4. Evaluate the effects of tablet use on chronic medical condition outcomes (e.g.,~          hypertension, diabetes) and mental health treatment initiation and engagement (e.g., for~          depression, PTSD, and substance use).~   "
36428|NCT03089788|"~     In this Project we will monitor the symptoms of cat allergic participants who live together~     with a cat which is immunized with FEL-CMV using the novel symptom recording method~     HypoScore, a General weekly symptom score, and a skin prick test before and after~     immunization of the cat. This project may enable us to determine if the scoring System and~     the tests are able to detect a difference in participant symptoms before and after~     immunization of the cats.~   "
36429|NCT03089775|"~     This two cohort study (Cohort A and B) is being conducted to assess the safety and efficacy~     of BBI-2000 for the prevention (Cohort A) and treatment (Cohort B) of delayed type~     hypersensitivity reaction.~   "
36430|NCT03089762|"~     Stromal vascular fraction (SVF) can easily be obtained from a mini-lipoaspirate procedure of~     fat tissue and platelet rich plasma (PRP) can be obtained from peripheral blood. Evaluated~     the safety and preliminary efficacy of administering SVF and PRP intra-articularly into~     patients with osteoarthritis grade 1 and 2.~   "
36431|NCT03089749|"~     The aim of the study is to quantitate Central Nervous System (CNS) autoantibody development~     in human blood using ELISA after human brain injury, spinal cord injury, and intra-axial~     brain surgeries.~   "
36432|NCT03089736|"~     The purpose of this study is to evaluate the effect of individual education and individual~     self-care measures on pain intensity, perceived health, mood and sleep during and after~     treatment with radiotherapy for head and neck cancer.~   "
36447|NCT03089541|"~     This one-year pilot study of 30 non-treatment seeking young adult e-cigarette/combustible~     tobacco product dual users (15 males/15 females) will use smartphone-based ecological~     momentary assessment (EMA) to gather real-time data of e-cigarette and combustible tobacco~     product behaviors during a 1-week cigarette/e-cigarette dual use period .(1) Participants~     will respond to daily random prompts assessing in-the-moment use of e-cigarettes/cigarettes~     and the subjective factors (ratings of satisfaction and withdrawal) and contextual factors~     (location, activity, social cues) associated with each episode of use. Participants will also~     complete daily electronic diaries to document e-cigarette use episodes/day, and satisfaction~     with the e-cigarette experience during the study.~   "
37917|NCT03070327|"~     The purpose of this phase I clinical trial is to test the safety of these CAR T cells in~     patients with myeloma.~      There are two parts of this study. Part 1 of the study consists of screening for BCMA,~     Lenalidomide assignment and cell collection. Part 2 of the study is treatment with modified~     CAR T cells.~   "
36433|NCT03089723|"~     Although a common problem, hand osteoarthritis (HOA) is less studied than knee and hip. In~     the age group of 71-100 years, the prevalence of symptomatic HOA reaches 26% of women and 13%~     of men. These patients lose hand strength and have difficulty with day-to-day manual~     activities. The main joints involved are the proximal and distal interphalangeals and the~     carpometacarpal joint of the thumb. In the educational Project PARQVE, the prevalence of HOA~     was 23.7% at inclusion in the program, and 47.4% after one year, with loss of grip strength.~     There is controversy over the effect of viscosupplementation in the treatment of~     rhizarthritis when considering pain. However, strength is a very important function parameter~     that must be evaluated for function and quality of life maintenance. Concerned about the~     importance of maintaining strength and function in our program (PARQVE), we have added~     specific exercises tom improve hand strength and range of motion. Trying to optimize the~     treatment and confronting questions about the effect of the joint wash, called placebo in the~     comparative studies with corticosteroid and/or hyaluronic acid injection, we did a work where~     all the patients will be washed with physiological saline solution but a group, after~     emptying, will receive 1mL of hyaluronic acid with mannitol.~      PURPOSE: To compare isolated lavage with lavage followed by injection of hyaluronic acid with~     mannitol into carpometacarpal osteoarthritis joint of the thumb.~      METHODS: Forty joints of patients with multiple osteoarthritis (rhizoarthritis, including)~     and comorbidities (two or more of: overweight or obesity, hyperglycemia, dyslipidemia,~     hyperuricemia, hypertension) will be allocated into two groups: Lavage (LS) and Lavage and~     Injection Hilauronic acid (LO). Both groups will undergo joint lavage with saline solution.~     The LO group will receive the 20 mg / mL hilauronic acid injection with 5mg mannitol. Both~     groups will be guided in the clinical treatment of osteoarthritis and metabolic syndrome and~     will be given daily exercises for the hands. They will be evaluated with the quick DASH~     questionnaire, Sollerman Test and by measuring the palmar, lateral and pulp-pulp grip~     strength, in addition to measuring the ROM and VAS pain moments immediately prior to the~     procedure, one, three and six months after the articular procedure.~   "
36434|NCT03089710|"~     Perioperative fluid management is crucial for patients' outcome. Muller et al developed a~     Mini-fluid challenge method  to predict fluid responsiveness and the efficacy. The~     investigators design the study to investigate the effectiveness of mini-fluid challenge test~     in prone position surgery.~   "
36435|NCT03089697|"~     This study is performed to evaluate safety and to explore the efficacy of a single~     intravenous dose of N-Rephasin® SAL200 (3 mg/kg) in addition to the conventional standard~     treatment, for persistent Staphylococcus aureus bacteremia in patients, for more than 48~     hours even after antibiotic treatment to which Staphylococcus aureus is susceptible.~   "
36436|NCT03089684|"~     This NHANES analysis compares self-reported dietary folate with serum and red blood cell~     folate status in U.S. adults.~   "
36437|NCT03089671|"~     Background: The risk of ureteric injury at the time of pelvic reconstructive surgery can be~     as high as 3% and the American College of Obstetricians and Gynecologists has stated that~     intraoperative cystoscopy should be done after all such procedures. Intravenous indigo~     carmine was routinely given during surgery to colour the urine bright blue and allow for~     assessment of ureteric integrity. In 2014, indigo carmine was no longer available worldwide~     and since then, surgeons have been searching for suitable alternatives. Vitamin B is a water~     soluble vitamin that colours the urine bright yellow and can be given immediately before~     surgery to help with ureteric visualization. Alternatively, 5% dextrose in water (D5W) can be~     used as the instillation fluid during cystoscopy to allow for urine jet visualization due to~     the difference in fluid viscosity. Both agents have been shown to be better than instillation~     with normal saline and are affordable and accessible in Canada.~      Objective: To identify which agent is superior for intraoperative ureteric visualization at~     the time of cystoscopy by determining the difference in detection rate of both ureteric jets~     using either preoperative oral vitamin B or intraoperative cystoscopic distension with D5W.~      Methods: This study will be a three-site (Mount Sinai Hospital, Sunnybrook Health Sciences~     Centre, St. Michael's Hospital), double-blinded, randomized control trial whereby female~     patients undergoing pelvic reconstructive surgery will be randomized to receive either~     preoperative vitamin B or intraoperative D5W cystoscopic instillation fluid. Parameters~     measured during surgery will include whether both ureteric jets were seen, time to~     visualization of both ureters, colour of jets, and surgeon satisfaction. Patients will also~     be seen at one week after surgery to assess for urinary tract infection. Sample size~     calculation based on previous studies demonstrated a need for 125 patients per study arm.~      Anticipated Clinical Significance: The findings of this study will be relevant to all~     surgeons performing intraoperative cystoscopy where ureteric visualization is required. The~     investigators believe the outcome of this study will help make cystoscopy shorter and more~     efficient for surgeons who often feel the pressure of time constraints within the operating~     room setting. In turn, decreasing the time of cystoscopy may reduce operating times which~     will benefit both the patient and hospital.~   "
36438|NCT03089658|"~     Expanded access to Avelumab solution for infusion will be made available for adult patients~     with mMCC whose disease has progressed after receiving at least one prior chemotherapy.~   "
36439|NCT03089645|"~     The purpose of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics and~     antitumor activity in adult subjects with selected advanced solid tumor malignancies~   "
36440|NCT03089632|"~     Patients with type-1 diabetes are more susceptible to motility-related upper gastrointestinal~     symptoms. Dietary interventions are one of the treatment pillars for these symptoms. Many~     gastrointestinal conditions other than celiac disease, are being increasingly treated with~     gluten-free diet (GFD). The role of GFD in non-celiac type-1 diabetic patients with~     dyspepsia-like symptoms has not been assessed before. In this study, type 1 diabetes patients~     with concomitant upper gastrointestinal symptoms will be asked to follow a 1-month GFD to~     assess changes in upper gastrointestinal symptoms and gastroduodenal motility before and~     after the dietary intervention.~   "
36441|NCT03089619|"~     Investigation of the volume stability of the alveolar ridge, the bone structure and soft~     tissue appearance at a delayed dental implantation using two bone substitute materials (1.~     Human-Spongiosa, gefriergetrocknet, CHB; 2. collacone®)~   "
36442|NCT03089606|"~     Explore association between intensity of C11-AMT PET at baseline, as measured by mean~     standardized uptake value (SUVmax at each lesion), total tumor metabolic volume, measurement~     of intra-tumoral and inter-lesional heterogeneity), with objective response rate (ORR) at 12~     weeks (as defined via RECIST 1.1) to pembrolizumab in patients with treatment-naïve~     metastatic melanoma.~   "
36443|NCT03089593|"~     The main objective of the study is to evaluate the thermogenic effect of ginger.~   "
36444|NCT03089580|"~     This study will evaluate the efficacy of intense pulsed light (IPL) therapy for the treatment~     of dry eye disease. One eye of the participant will be randomized to receive the IPL~     treatment.~   "
36445|NCT03089567|"~     Comparison of the salivary levels of Streptococcus mutans in pediatric patients with Early~     Childhood Caries after the application of Silver Diamine Fluoride or 5% Sodium Fluoride~     Varnish~   "
36446|NCT03089554|"~     This is a substudy (Part 2) of a larger two-part clinical trial including both observational~     and therapeutic (interventional) cohorts to assess the progression free survival ratio of~     patients treated with a targeted therapy based on genomic analysis results and recommendation~     by the Markey Cancer Center Molecular Tumor Board (MCC MTB).~   "
36465|NCT03089307|"~     The present study aims to identify and compare the efficacy and safety of two different~     session frequency protocols (once vs twice per week) of low intensity extracorporeal~     shockwave treatment (LI-ESWT) using Aries ED device, in men with mild-moderate and severe~     vasculogenic ED, who have previously responded to oral PDE5-Is~   "
36448|NCT03089528|"~     The use of videolarygoscopy (VL) as first choice for tracheal intubation versus direct~     laryngoscopy (DL) is a matter of debate.~      These two methods were compared in several studies. Videolaryngoscopes may reduce the number~     of failed intubations, particularly among patients presenting with a difficult airway. They~     improve the glottic view and may reduce airway trauma. DM is accepted as a risk factor for~     difficult intubation.~      The aim of this study is to compare VL to DL in adult patients requiring tracheal intubation~     for anesthesia, in terms of intubation success, glottic view quality, intubation failure,~     intubation time, conversion to another laringoscopy method and adverse outcomes related to~     tracheal intubation.~   "
36449|NCT03089515|"~     Many Survivors in the World Trade Center (WTC) clinical program have a clinical syndrome~     characterized by chronic obstruction in small airways and persistence of lower respiratory~     symptoms despite therapy. This study will test the hypothesis that persistent symptoms in WTC~     Survivors are associated with abnormal small airways whose dysfunction is amplified during~     exercise and is associated with biologic evidence of inflammation and remodeling. The results~     from this study will have important treatment implications for our WTC population with~     potential applicability to larger populations with either inhalational lung injury and/or~     airway diseases such as asthma and chronic obstructive pulmonary disease.~   "
36450|NCT03089502|"~     Breast cancer is the leading cause of cancer among Canadian women with nearly 26,000 new~     cases diagnosed each year. Fortunately, advancements in diagnostic tools and curative~     treatments have significantly improved overall survival. However, the development of cardiac~     toxicity (including asymptomatic and symptomatic heart failure) associated with use of~     anthracycline containing chemotherapy and targeted therapies including trastuzumab limits~     improvements in survival for women with breast cancer. Cardiac toxicity is a life threatening~     complication that leads to reduced physical functioning and quality of life. The increased~     risk is associated with shared risk factors among cancer and heart failure and the direct~     influence of cancer therapy on the cardiovascular system. Cardiac rehabilitation (CR)~     (including exercise training and education/counselling) has been shown to improve health~     outcomes, reduce heart failure related hospitalizations and modestly improve mortality among~     individuals with non-treatment related heart failure and may benefit women with breast cancer~     and treatment related cardiac toxicity (BC-CT). Therefore, this single centre, randomized~     control trial aims to determine if participation in an exercise based CR program can improve~     cardiorespiratory fitness, cardiovascular function/structure and health, and quality of life~     among women with BC-CT.~   "
36451|NCT03089489|"~     PGD is a syndrome characterized by alveolocapillary barrier structural and functional~     alterations with surfactant inactivation and vascular permeability increase, which cause lung~     edema, parenchymal infiltrate and progressive hypoxemia.~      PGD may be enhanced in lung donor. Inflammatory and structural changes may be present in the~     lungs before organ recovery and/or after organ preservation. The investigators aim to~     identify the surfactant protein, inflammatory and structural changes in lung donor before and~     after cold ischemia, and biomarkers to PGD in lung recipients.~   "
36452|NCT03089476|"~     It is hypothesized that food allergy is preceded by atopic dermatitis (AD), due to a~     disruption of skin barrier which can predispose one to food sensitization through the skin.~     The central hypothesis is that increased transepidermal water loss (TEWL) assessment and skin~     tape strip analysis (STS) of lipid and filaggrin breakdown products will be predictive~     markers for the development of AD. Additionally, the associated changes in TEWL and STS will~     further improve the identification of infants at risk of early food sensitization, compared~     to family history alone.~   "
36453|NCT03089463|"~     This observational cohort study aims to develop a novel risk stratification system~     implementing biomechanics to aid in the prevention of diabetic foot ulcers.~   "
36454|NCT03089450|"~     to evaluate safety and efficacy of CGBIO stent(DES) compared to Biomatrix flex stent(DES)~   "
36455|NCT03089437|"~     The effects of 12 hours of prolonged standing will be compared to prolonged standing on a~     high fat tolerance test the following day. Plasma triglycerides, insulin, and glucose will be~     measured in a crossover study design.~   "
36456|NCT03089424|"~     Photobiomodulation therapy (PBMT) is a non-pharmacological method commonly used in treatment~     of musculoskeletal disorders. However, there are few high-quality scientific evidence to~     support the effectiveness of this therapy in the treatment of patients with chronic low back~     pain, at short, medium and long term. The present research project aims to evaluate the~     effects of PBMT in patients with chronic non-specific low back pain.~   "
36457|NCT03089411|"~     Collection of retrospective additional data (survival, biological, disease response data)~     following the study IFM 2013-04.~   "
36458|NCT03089398|"~     The purpose of the study is to learn which treatment option is better for patients who have~     multi-vessel coronary artery disease (blockages in more than one vessel supplying blood to~     the heart muscle). The treatment options this study will compare are: (1) Hybrid Coronary~     Revascularization [HCR] (a combination of surgery and catheter procedures to open up clogged~     heart arteries) and (2) Percutaneous Coronary Intervention [PCI] (catheter procedures alone~     to open up clogged heart arteries). There are no new or experimental procedures being~     tested in this study: both HCR and PCI are well-established procedures and are regularly~     performed in patients who have coronary artery disease. But, the FDA has not approved the~     drug-eluting stents used in PCI for all types of coronary artery disease. We have received an~     Investigational Device Exemption from the FDA to use the drug-eluting stents in this trial in~     the same way that they are used in clinical practice. The study being proposed here will use~     rigorous scientific methods and should result in a very high level of certainty about which~     procedure is best for patients with coronary artery disease.~   "
36459|NCT03089385|"~     The objective of this project is to develop, validate, and implement a tool to help manager~     hypertension in patients on hemodialysis.~   "
36460|NCT03089372|"~     The present study evaluates the efficacy and safety of repetitive treatments of Low Intensity~     Extracorporeal Shock Wave Treatment (LI-ESWT) using Aries ED device in men with mild-moderate~     and severe vasculogenic ED, who have previously responded to oral PDE5-Is, and completed 6 or~     12 sessions of LI-ESWT with Aries device during the last 6 month.~   "
36461|NCT03089359|"~     This study evaluates the predictive value of soluvent urokinase plasminogen activator~     receptor (suPAR) and lactate with respect to serious conditions among patients presenting to~     the EMS with unspecific symptoms.~   "
36466|NCT03089294|"~     The present study aims to identify the efficacy saturation effect of low intensity~     extracorporeal shockwave treatment (LI-ESWT) using Aries ED device in men with mild-moderate~     and severe vasculogenic ED, who have previously responded to oral PDE5-Is. The efficacy and~     safety of 4 different session frequency protocols will be compared.~   "
36467|NCT03089281|"~     The primary objective is to evaluate the benefit of the SmartDelay™ algorithm in patients~     with a prolonged RV-LV interval.~   "
36468|NCT03089268|"~     Different subtypes of serrated lesions have been recently described. Among them, both sessile~     serrated polyp/adenoma (SSP/A) and traditional serrated adenoma (TSA) could have malignant~     potential through the serrated pathway or CIMP. These lesions, as a potential source of~     interval cancer, should also be considered in colorectal cancer (CRC) population-based~     screening programs. It is believed that this new described pathway could be responsible for~     up to 30% of all CRC.~      Unlike the traditional adenoma, serrated lesions are difficult to diagnose because of their~     particular endoscopic appearance and their still unclear histological criteria. Furthermore,~     they have specific molecular changes and, through them, they could evolve into CRC faster~     than the adenoma. The real prevalence of the serrated lesions and their specific risk for~     developing new synchronous/metachronous lesions, or even malignancy, remains unknown. For all~     these reasons, we don't know if these patients could constitute a different CRC-risk group~     and if specific recommendations are needed during their follow-up.~      This is a prospective longitudinal study developed within the framework of the CRC-screening~     program in the Valencian Community (Spain). We expect to include a total of 700 individuals~     who will be followed during 10 years.~      In our study, we will collect epidemiologic variables related to the patient, variables~     related to all the polyps, and mutational (BRAF, KRAS, MSI), and CpG-island methylation~     status of serrated lesions. Strict endoscopic and histological criteria will be applied for~     the diagnosis of serrated lesions. All lesions detected at the index colonoscopy and during~     follow-up will be evaluated.~      The purpose of this study is to correlate epidemiologic data, histological characteristics~     and the molecular profile of the serrated lesions with findings during follow-up, in order to~     define stratified groups according to their risk of developing new lesions or CRC in the~     future.~   "
36469|NCT03089255|"~     Traumatic lesions are the leading causes of admission to the emergency center (39%), isolated~     non-surgical lower limbs trauma are in the foreground. Two recent meta-analyzes suggest the~     value of Low Molecular Weight Heparins (LMWH) which would reduce symptomatic Thromboembolism~     Events (TE) in patients with lower limb trauma. However, many recent studies conclude to the~     need of stratifying the TE risk according to the patient and the nature of his trauma to~     obtain an individualized therapeutic decision.~      The retrospectively established L-TRIP (cast) score allows stratification of the risk without~     taking into account the type of trauma. The TIP score (Trauma, Immobilization and Patient)~     was established by consensus of international experts via the Delphi method.~      We suggest that the application of the TIP score to rationalize indications of~     thromboprophylaxis in patients with isolated non-surgical trauma of a lower limb should~     reduce the rate of anticoagulation prescription without increasing the risk of symptomatic~     thromboembolic complications with a direct benefit for patients and medico-economic for the~     society.~   "
36470|NCT03089242|"~     Profiling of microRNAs and long noncoding RNAs (lncRNAs) in patients undergoing cardiac~     surgery. Analysis: Prediction of acute kidney injury by plasma expression profile of~     microRNAs?~   "
36471|NCT03089229|"~     Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by a disturbance~     of epidermal-barrier function that results in intensely pruritic subacute and chronic~     eczematous plaques. The current therapy of AD is reactive, where the flares are treated~     through symptomatic management with topical corticosteroids and calcineurin inhibitors. Given~     that these medications have long-term side-effects, and given the chronically relapsing~     immunopathogenic nature of AD, there is an imperative need for safer anti-inflammatory~     medications. Haus Bioceuticals (Haus) has developed a novel topical treatment for~     eczema/atopic dermatitis (AD) denoted HAT01H, and have demonstrated that HAT01H is safe and~     profoundly effective in the treatment of AD, controlling signs and symptoms in 85% of~     patients with AD. This study is aimed to further test the efficacy and safety of topical~     HAT01H in patients with moderate to severe atopic dermatitis.~   "
36472|NCT03089216|"~     The aim of this clinical study is to evaluate the efficacy and dental sensitivity associated~     with Combined Bleaching Technique (in-office + at-home) varying in-office bleaching~     application under two different time protocols, and dentifrice containing arginine 8% and~     carbonate calcium use. One hundred eight participants who meet the study inclusion criteria~     will be selected. The desensitizing agent used will be a dentifrice containing 8% arginine~     and calcium carbonate. In each evaluation will be determined: tooth sensitivity and color.~     The data collected will be submitted to the factorial statistical analysis for evaluation of~     color and chi-square test for tooth sensitivity (α = 5%).~   "
36473|NCT03089203|"~     This is a single center, single arm Phase I study to establish the safety and feasibility of~     intravenously administered lentivirally transduced dual PSMA-specific/ TGFβ-resistant CAR~     modified autologous T cells (CART-PSMA-TGFβRDN cells) in patients with metastatic castrate~     resistant prostate cancer.~   "
36474|NCT03089190|"~     A double-blind, randomized crossover design with four arms including three experimental~     conditions and placebo will be applied. After having successfully completed screening~     procedures, eligible participants will be invited to four separate test days. The test days~     are separated with at least 7 days, however 4 days can be accepted for logistical reasons.~     During the entire course of the study, participants must remain weight stable and not change~     their diet or physical activity level. Significant changes in diet, physical activity level~     (evaluated by the sub-investigator) or weight change ±3 kg over the course of the study (from~     screening to completion of the last test day) results in exclusion of that subject.~   "
36475|NCT03089177|"~     The investigators previous studies show that community gardening is associated with reduction~     of key health behaviors for cancer prevention in diverse populations. Community gardeners eat~     more fruits and vegetables per day, are more physically active, and are more likely to avoid~     age-associated increase in body mass index (BMI). The effect is partially explained by the~     finding that gardeners are more socially involved, and feel more social support than~     non-gardeners.~      The investigators propose a randomized controlled trial to determine whether community~     gardening improves cancer-preventive behaviors among a multi-ethnic, low-income adult~     population and elucidate the pathways that shape cancer-preventive behaviors. A randomized~     controlled trial is needed to demonstrate that the observed behavioral differences are due to~     the effect of gardening as an intervention rather than self-selection by gardeners.~   "
36629|NCT03087149|"~     The purpose of this study is to determine wheather the monitored vitamin D (vit D) therapy is~     safer and more effective than standard therapy in pretrem infants.~   "
36476|NCT03089164|"~     Hemodynamic measurements obtained during pulmonary artery catheterization are essential for~     the diagnosis and classification of pulmonary hypertension. Traditionally, right heart~     catheterization (RHC) is done in the supine position. Cardiac output is known to change~     significantly based on position, due to the effects of gravity on venous return. There has~     not been a systematic investigation into these postural effects on pulmonary arterial~     pressures nor their effect on the diagnosis of pulmonary hypertension. It is our intent to~     study the differences in measurements obtained during RHC when the patient is supine, seated,~     and standing.~   "
36477|NCT03089151|"~     An interdisciplinary team with extensive garden study experience conducted a pilot randomized~     controlled clinical trial to see whether gardening reduced risk factors for diseases like~     cancer and heart disease. The pilot trial will provide preliminary data on associations~     between human microbiome, diet, physical activity, and social interactions and the outcomes~     of weight status and key inflammatory biomarkers.~   "
36478|NCT03089138|"~     Efficacy and Safety of Regan Tangjiang for treating the common cold with wind-heat syndrome:~     A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo and Active-Controlled Phase~     2b Study~   "
36479|NCT03089125|"~     This research study is evaluating a behavioral intervention designed to help people with~     advanced lung cancer manage dyspnea (i.e., breathlessness or shortness-of-breath).~   "
36480|NCT03089112|"~     A Randomized, Open-label, Crossover Study to Investigate the Pharmacokinetic drug~     interactions and the Safety between HGP1607 and HGP1501 in Healthy Male Volunteers~   "
36481|NCT03089099|"~     As prostate cancer progresses into castration-resistant stage from initial hormone-sensitive~     status, the biological behavior of tumor cells that dissociated from primary lesions changed.~     Considered a liquid biopsy, these circulating tumor cells (CTCs) can show how a patient's~     cancer responded to treatments. The purpose of this study is to determine whether~     sequentially analyzing the expression of molecular markers in high volume circulating tumor~     cells in metastatic castration-resistant prostate cancer patients can predict the therapeutic~     effects and outcomes of these patients.~   "
36482|NCT03089086|"~     To estimate the effect on carriage, all year 10, 11, and 12 students will be offered 4CMenB~     vaccination in South Australia through schools over the study period with 50% of the students~     enrolled receiving the vaccine in 2017 and 50% in 2018. In year 10 and 11 students, posterior~     pharyngeal swabs will be obtained at baseline and 12 months post baseline to estimate the~     difference in carriage prevalence of all genogroups of N. meningitidis between vaccinated and~     unvaccinated participants.~   "
36483|NCT03089073|"~     Observation of safety and efficacy of Minirin Melt® in adult patients with nocturia~   "
36484|NCT03089060|"~     Amputation injuries of the fingertip are common in all ages. For decades it is known that~     conservatively treated fingertips can regenerate skin and soft tissues to form a functionally~     and cosmetically excellent new fingertip. Unfortunately, little is known about the mechanisms~     controlling this ability that, in humans, is confined to the fingertips. Even less is known~     about the bacteria that regularly colonize these wounds without noticeable negative impact on~     regeneration and healing. Medical evidence on fingertip regeneration in humans is largely~     limited to retrospective studies and case reports. This study will be the first randomized~     controlled trial on the conservative treatment of fingertip amputations in children and~     adults.~      When managed without surgery, self-adhesive polyurethane film dressings are commonly used to~     establish a wet chamber around the injury. This provides the best conditions for tissue~     regeneration inhibiting the formation of scar tissue at the same time. Unfortunately these~     dressings do not offer mechanical protection, they do not stick to wet skin and leak~     malodorous wound fluid. The investigators therefore developed a silicone finger cap that~     deals with these problems offering a mechanically protected, wet chamber around the injury~     for optimal regeneration conditions. This finger cap also offers a puncturable reservoir for~     excess wound fluid, which by this route can be routinely analyzed for diagnostic and research~     purposes.~      This randomized controlled trial will for the first time test acceptance, safety and efficacy~     of this novel medical device in comparison with conventional self-adhesive film dressings~     while gathering information on the clinical course and outcome of conservatively treated~     fingertip amputation injuries.~      Based on sample size calculations for primary outcome, 22 patients older than 2 years will be~     enrolled within 24 hours after having suffered an injury distal to the distal interphalangeal~     joint comprising all layers of the skin with a substance defect that cannot be primarily~     adapted without further shortening of the finger or plastic surgery. Participants are~     randomly assigned to start their treatment for the first two weeks either with a conventional~     film dressing or with the novel silicone finger cap. They will be changed to the other~     modality for another two weeks before the patient or the guardian can decide, if they would~     want the film dressing or the finger cap for the rest of the treatment.~   "
36485|NCT03089047|"~     To compare the physiologic benefits of rejuvenated RBCs (rejRBCs) to standards RBCs (PRBCs),~     the investigator will emulate critical conditions by safely maximizing stress on the~     cardiovascular system, in an elective, feasible volunteer study. VO2max will be measured in~     an anemic, post-donation, pre-transfusion state, and also after transfusing 18-day-old,~     autologous blood randomized to standard storage or standard storage with rejuvenation. The~     investigator hypothesizes that transfusion of standard PRBCs is less effective at increasing~     oxygen delivery (measured by VO2max) compared with transfusion of rejRBCs~   "
36486|NCT03089034|"~     Chronic Heart Failure (CHF) is one of the leading causes of death in Singapore. Although it~     is well established that CHF patients in Singapore are less likely to be referred to~     palliative care services than cancer patients, little data is available on end-of-life (EOL)~     experience of advanced CHF patients in Singapore, including the inter-relationships between~     patient decision-making, quality of life trajectories, and health and cost consequences.~   "
36487|NCT03089021|"~     This study investigate the short term effect of Maitland in comparison to Mulligan~     mobilization with sub-acute and chronic non specific neck pain to improve neck pain, pain~     pressure threshold, rang of motion, joint position sense, disability, and to evaluate the~     interaction with psychological factors.~      Study design: experimental study~   "
36488|NCT03089008|"~     The purpose of the present study is to examine the long-term effect of eccentric exercises~     compared with stretching exercises on patients with achillodynia.~   "
36489|NCT03088995|"~     The purpose of the OPDEP pilot study is to assess the feasibility of implementing a~     pre-operative HIV / HCV / HBV screening proposal for all persons over 18 years of age and~     refer for surgical intervention under general anesthesia in the Department of Stomatology of~     the Pitié-salpêtrière hospital.~      Patients undergoing treatment in Stomatology have particular areas at risk for the infections~     we are looking for: young patients, precarious situation, drug use, migrants ...~      The aim is to evaluate the conditions for a generalization of screening in the framework of~     the preoperative assessment.~   "
37918|NCT03070314|"~     In this bioavailability trial should be shown that the one of the main active constituent in~     alcoholic echinacea extracts, the alkylamide dodeca-2E,4E,8Z,10E/Z-tetraenoic acid~     isobutylamide (short: tetraen) is bioavailable in children of different age groups after~     intake of 5 Echinaforce junior tablets.~   "
36490|NCT03088982|"~     Background :The European General Practitioners Research Network (EGPRN) designed and~     validated a comprehensive definition of multimorbidity using a systematic literature review~     and qualitative research throughout Europe. This survey assessed which criteria in the EGPRN~     concept of multimorbidity could detect decompensating patients in residential care within a~     primary care cohort at a 6-month follow-up.~      Method: Family Physicians included all multimorbid patients encountered in their residential~     care homes from July to December 2014. Inclusion criteria were those of the EGPRN definition~     of Multimorbidity. Exclusion criteria were patients under legal protection and those unable~     to complete the 2-year follow-up. Decompensation was defined as the occurrence of death or~     hospitalization for more than seven days. Statistical analysis was undertaken with uni- and~     multivariate analysis at a 6-month follow-up using a combination of approaches including both~     automatic classification and expert decision making. A Multiple Correspondence Analysis (MCA)~     and a Hierarchical Clustering on Principal Components (HCPC) confirmed the consistency of the~     results. Finally a logistic regression was performed in order to identify and quantify risk~     factors for decompensation.~   "
36491|NCT03088969|"~     The back pain connected to the work stay a major problem in industrialized countries, in~     particular because of the repercussions of this affection on the work (sick leave,~     absenteeism, handicap and inaptitude). It is difficult to consider among all the patients~     with a Chronic Low Back Pain in the work: how much they are going to stop. However,~     Investigator can consider that approximately 20 % of the patients have a sick leave. Several~     studies showed well that more the sick leave work stoppage goes on more the risk of not~     resumption of work increases. Several risk factors were associated to the evolutionary~     forecast of the pathology and thus to the extension extra time of the sick leave: individual,~     environmental, psychosocial and organizational.~      The evaluation of the self-efficiency perceived of return in the work of the patients by a~     validated auto-questionnaire is thus an additional objective parameter determining the risk~     factors of unfavorable evolution of the patients with Low Back Pain. This parameter also~     allows highlight other levers of actions in the therapeutic education.~   "
36492|NCT03088956|"~     The objectives of the study are to; (1) estimate the change in disease -related cognitive~     decline over 1 year on a battery of cognitive tests administered to participants with~     early-stage symptomatic Behavioral Variant Frontotemporal Dementia (bvFTD) phenotypic~     variant; (2) identify the cognitive test or brief battery of cognitive tests which are the~     most sensitive to detect bvFTD progression; (3) determine the optimal schedule of~     administration of cognitive tests to detect bvFTD progression; (4) evaluate the relationship~     between cognitive tests and measures of behavior, function, caregiver's burden, quality of~     life (QOL); and (5) obtain blood samples for genetic and exploratory biomarkers correlations.~   "
36493|NCT03088943|"~     This project aims at exploring measures of diastolic function perioperatively.~   "
36494|NCT03088930|"~     This study will evaluate the efficacy of crizotinib as induction therapy in participants with~     surgically resectable ALK rearrangement, ROS1 rearrangement, or MET exon 14 mutation positive~     NSCLC.~   "
36495|NCT03088917|"~     Objective:~      To coordinate active tracing of chronic hepatitis C patients lost to follow-up to inform them~     about there disease severity and treatment options.~      Study design: This is a prospective cohort study, which will start as a pilot study in the~     Radboudumc Population: lost to follow-up chronic hepatitis C patients in the region Nijmegen.~     This so-called lost population consists of all patients, that in the past have been~     identified at the Radboudumc but who are currently lost to or have been withdrawn from~     follow-up. The time-span of interest will be 2000-2015. We estimate that this project will~     retrace 100 lost patients through this search.~   "
36496|NCT03088904|"~     The purpose of the study is to investigate and compare the immune responses to influenza~     vaccination in monozygotic (identical) and dizygotic (fraternal) twins to determine the roles~     of genetics and environment in the response to flu vaccination.~   "
36497|NCT03088891|"~     Athletes, especially in endurance sports, are at increased risk of oxidative stress and~     inflammation-related diseases and injuries. The production of reactive oxygen and nitrogen~     species (RONS) and inflammatory markers increase during exercise and especially during~     altitude training. Antioxidant supplementation is commonly used among athletes in the belief~     that it prevents oxidative stress and oxidative damage. A transient increase of RONS is~     however necessary to activate signaling cascades initiating training adaptation. Antioxidant~     supplementation has been shown to inhibit the exercise effects in several independent~     studies, possibly by interfering/reducing the signal cascades initiated by RONS. However, it~     is unknown whether a high intake of antioxidant rich foods can affect the amount of RONS,~     inflammation markers and/or training adaptation. The investigators want to examine whether an~     increased intake of natural antioxidants in the form of antioxidant-rich foods fruits,~     vegetables and berries, in line with the official Norwegian dietary advice can affect~     antioxidant status, immune function and training adaptation associated with altitude training~     in Norwegian elite athletes.~   "
36498|NCT03088878|"~     This is Phase 1b/2 study to investigate the safety and effectiveness of the investigational~     drug, cirmtuzumab, when given in combination with ibrutinib in patients with B-cell lymphoid~     malignancies. Cirmtuzumab is a monoclonal antibody that attaches to a protein (called ROR 1)~     that is found on hematologic tumor cells. ROR1 has been shown to play a role in cell~     signaling that cause leukemia cells to grow and survive. ROR1 is rarely found on healthy~     cells.~   "
36499|NCT03088865|"~     Implementation of the initial specimen diversion technique, in which the first milliliter of~     the venipuncture sample is not injected into the culture bottle, led to a significant~     reduction in blood culture contamination rates. This technique is based on the assumption~     that the skin plug aspirated during venipuncture is a major source of contaminating bacteria.~     One such diversion method is aspirating the first blood volume into a blood collection tube.~     It has, however, been suggested that regular blood collection tubes carry contaminants from~     the tube's stopper into the blood cultures drawn afterwards, thereby increasing contamination~     rates. The aim of this trial is to examine the effect of aspirating the first blood volume~     into a regular blood collection tube on blood culture contamination rate.~   "
37919|NCT03070301|"~     The purpose of this study is to test any good and bad effects of the combination of LEE011~     with everolimus on the participant and the cancer.~   "
36500|NCT03088852|"~     Hypomagnesemia is a common entity in the inpatient and outpatient setting. in previous~     retrospective study hypomagnesemic patients have higher mortality and longer hospitalization.~     whether hypomagnesemia is merely a marker of poor prognosis, or whether replacing it can~     improve outcomes is unclear. The current standard of care is to discharge these patients~     without workup or further treatment, even if patients had received intravenous therapy while~     hospitalized. The investigator wish to examine prospectively whether giving replacement~     therapy affects mortality, length of hospital stay and overall well-being. In order to~     replete intracellular levels and replete magnesium stores, magnesium should be given for~     several months.~   "
36501|NCT03088839|"~     Amyotrophic Lateral Sclerosis (ALS) is a rare disease with a worldwide incidence of 2-3 cases~     per 100,000 individuals/year and it is characterized by progressive neurodegeneration of~     motor neurons. When motor neurons degenerate the ability of the brain to initiate and control~     muscle movement is lost. ALS manifests in two forms: Familiar ALS (FALS) with inherited risk~     genotypes, accounts for only 10% of cases and sporadic ALS (SALS) without apparent~     heritability accounts for 90% of cases. ALS can occur in both female and male subjects at any~     age but is more common in people aged over 40.~      Although the molecular mechanism underlying the pathogenesis of ALS is still under~     investigation, recent research has revealed that diseases affecting motor neurons may be~     associated to alterations of RNA metabolism and biogenesis of small non-coding micro RNAs~     (miRNAs). miRNAs are circulating molecules, whose expression profiles are widely described to~     have an important potential in monitoring the progression of a disease, to promote the~     development of more targeted therapies and/or to determine the effectiveness of treatments.~     Altered patterns of specific miRNAs expression have been described in several pathological~     conditions. Evidence shows a significant reduction in the levels of certain miRNAs also in~     patients with ALS. Among others, miRNA-218 has been described to play a critical role in the~     onset of motor neurons differentiation and in establishing cell identity and fate.~      Changes in the levels of miRNA-218 in the serum of ALS patients may potentially provide~     useful tools to determine the possible association with this disease and to candidate it as~     indicator of disease progression.~   "
36502|NCT03088826|"~     Oxycodone and Hydrocodone are the most commonly used oral opioid analgesics in the emergency~     department and in outpatient settings. Both medications have a very high potential for abuse~     due to the prominence of the euphoric effect (abuse liability) and relative lack of bad or~     negative effects (likeability). The highly addictive properties of these medications lead~     to recurrent ED visits for repetitive dosing and prescribing that may lead to abuse, misuse,~     development of dependence and addiction, and, most importantly, death due to overdose. In~     contrast, several research papers demonstrated that administration of MSIR results in similar~     analgesic efficacy to Oxycodone and Hydrocodone but with significantly less euphoric and~     rewarding associated effects. In addition, consumption of large doses of MSIR leads to~     dysphoria, vomiting and sedation (negative effects). To the investigators' knowledge, there~     are no randomized controlled trials in the ED that directly compared analgesic efficacy of~     MSIR to Percocet~   "
36503|NCT03088813|"~     A Randomized, Open Label Phase 3 Study of Irinotecan Liposome Injection (ONIVYDE®) versus~     Topotecan in Patients with Small Cell Lung Cancer Who Have Progressed on or after~     Platinum-based First-Line Therapy~      The study will be conducted in two parts:~        1. Dose determination of irinotecan liposome injection~        2. A randomized, efficacy study of irinotecan liposome injection versus topotecan~   "
36504|NCT03088800|"~     Current literature supports ibuprofen and APAP are the most commonly used analgesics in the~     pediatric ED for acute mild to moderate traumatic/non-traumatic pain. However, the analgesic~     benefits of combination ibuprofen and APAP in this specific setting does not exist, but~     instead only as it applies to pediatric patients with postoperative pain. Thus, we have~     designed a double-blind, randomized, controlled clinical trial to evaluate analgesic~     efficacy, safety and feasibility of combination therapy to potentially broaden its clinical~     application in the pediatric ED. The investigators' hypothesize that combination oral~     ibuprofen and APAP therapy is superior to either drug alone and is an excellent analgesic~     modality for controlling acute mild to moderate traumatic/non-traumatic pain in the pediatric~     ED.~   "
36505|NCT03088787|"~     The primary purpose of this study is electronic data collection of arterial pressure waveform~     signals in patients with Aortic Stenosis. The collected digital pressure waveform data will~     be used to assess the feasibility of using the arterial pressure signal as a decision support~     tool for early detection of aortic stenosis conditions. Furthermore we evaluate hemodynamic~     parameters before and after valve repair and its correlation with outcome.~   "
36506|NCT03088774|"~     This project studies the effects of involving patients in the development of a~     web-application.~   "
36507|NCT03088761|"~     The changes in the cuff pressure in the absence of nitrous oxide are less clear.In the~     current study, we aim to determine the changes in cuff pressure over time in infants~     undergoing myelomeningocele repair in prone position under general anesthesia in the absence~     of N2O.~   "
36508|NCT03088748|"~     The purpose of the study is to acquire kinematic in vivo fluoroscopy data using the~     University of Tennessee's tracking fluoroscopy system (TFS) from subjects who were implanted~     with the Smith & Nephew Journey II posterior cruciate retaining (PCR) total knee arthroplasty~     (TKA) or Journey II bi-cruciate retaining (BCR) TKA. CMR has previously collected data for~     the Smith & Nephew BCS TKA and compared these kinematics data to those of normal knees.~   "
36509|NCT03088735|"~     It has been previously shown that although the activation of the embryonic genome can begin~     as early as two days of initiation of the embryonic development (D2), it is expressed on day~     3 (D3). Without this activation, the embryo can not continue its development. Therefore, it~     has been suggested that extended culture to blastocyst stage could be an option to identify~     and better select embryos that have been able to carry out this activation. The purpose of~     this study is to compare cumulative pregnancy and live birth rates following transfer of~     cleavage embryos or blastocysts.~   "
36510|NCT03088722|"~     This proposed study, to be run by Marie Stopes International Organisation Nigeria (MSION)~     will investigate whether Community Health Extension Workers (CHEWs) in Nigeria can insert and~     remove contraceptive implants to the same level of safety and quality as a nurse or midwife,~     and whether this is acceptable to their clients and colleagues. The study will also document~     feasibility issues which would be relevant to any future national programmatic scale-up.~   "
36511|NCT03088709|"~     Historically, the best results of allogeneic SCT have been obtained when the stem cell donor~     is a human leukocyte antigen (HLA)-matched sibling, however, this is only available for~     approximately 30 percent of patients in need for SCT. Alternative donor sources include~     matched unrelated donor utilizing the donor registry, cord blood transplant and mismatched~     donor transplant. A human leukocyte antigen (HLA)-haploidentical donor is one who shares, by~     common inheritance, exactly one HLA haplotype with the recipient, and includes the biologic~     parents, biologic children and full or half siblings. There is strong body of evidence~     supporting the use of haplo-SCT in patient who lack a matched sibling or unrelated donor with~     high rates of successful engraftment, effective Graft Versus Host Disease (GVHD) control and~     favorable outcomes comparative to those seen using other allograft sources, including~     HLA-matched sibling SCT. Furthermore, it provides a cost-efficient donor option in a timely~     manner especially for patients who need to proceed quickly to transplant due to concern of~     disease relapse/progression.~   "
36512|NCT03088696|"~     Assessment of the effectiveness of PC 6 Neiguan with conventional acupuncture for~     preventing PONV (PostOperative Nausea and Vomiting) after laparoscopic surgery.~   "
36513|NCT03088683|"~     In Laparoscopic Sleeve Gastrectomy, retraction of the left lobe of the liver is important for~     an effective visualisation. There are many retractors available for this retraction. A study~     is designed to compare two different liver retractors for liver trauma; Nathanson liver~     retractor that is used more commonly and Reveel liver retractor that has more recent history~     of use.~   "
36514|NCT03088670|"~     To demonstrate that efficacy of Gosogliptin as Monotherapy and in Combination with Metformin~     is non-inferior to efficacy of Vildagliptin as Monotherapy and in combination with Metformin~     in the effects on glycosilated hemoglobin (HbA1c) at Week 12 and Week 36 compared to baseline~     (Week 0).~   "
36515|NCT03088657|"~     The Mood Disorder Cohort Research Consortium (MDCRC) study is designed as a naturalistic~     observational prospective cohort study for early-onset mood disorders (major depressive~     disorders, bipolar disorders type 1 and 2) in South Korea.~   "
36516|NCT03088644|"~     The primary purpose of this study is to measure the whole body distribution and radiation~     dosimetry of 18F-JNJ-64413739 (Part A), to measure the uptake, distribution, and clearance~     (CL) of 18F-JNJ-64413739 in the brain of healthy male subjects by Positron Emission~     Tomography (PET) and to model tissue specific kinetics of 18F-JNJ-64413739 with the~     appropriate input function (IF) (Part B), to measure subject test retest variability in the~     distribution of 18F-JNJ-64413739 in the brain of healthy male subjects by comparing PET scans~     obtained at least 1 week apart (Part C) and following single oral dose administration of~     JNJ-54175446, to measure the blocking of 18F-JNJ-64413739 uptake in the brain at the time to~     reach maximum plasma concentration (tmax) of JNJ-54175446 and model the exposure/receptor~     interaction of JNJ-54175446 in healthy male subjects (Part D).~   "
36517|NCT03088631|"~     The relationship between serum progesterone level on the day of human chorionic gonadotropin~     administration and outcome of in vitro fertilization /intracytoplasmic sperm injection and~     embryo transfer has been controversial for several decades. some studies presented data~     against the negative effect of premature luteinization and reported that elevated serum~     progesterone had no adverse effect on pregnancy rates in fresh embryo-transfer cycles within~     different ovarian responses.However,most studies have evaluated the association between serum~     progesterone level and clinical outcome in fresh in vitro fertilization /intracytoplasmic~     sperm injection cycles, and advocated that serum progesterone elevation on the day of human~     chorionic gonadotropin administration may adversely affect clinical outcome by jeopardizing~     endometrial receptivity.~      In addition, the underlying mechanism through which premature luteinization influences~     clinical outcomes is elusive. some proposed that premature luteinization cause impairment of~     the endometrial receptivity, which may indicate a change in the implantation window, is more~     likely to be affected than the oocyte.whereas some documented that the compromised quality of~     oocytes might also be a cause.~      The cut off point of premature luteinization is not well established till now. Premature~     luteinization has been variously defined based on serum P levels, with thresholds of 0.9-1.5~     ng/mL being used.~      Previous studies have shown that metformin inhibits the first steps of steroidogenesis dose~     dependently reducing granulosa cells progesterone output .Moreover other authors have~     recently reported that low dose metformin could improve in vitro fertilization outcome in non~     poly-cystic ovarian syndrome repeaters.So,considering the safety of this drug before~     pregnancy, metformin can be given to consenting patients from first ultrasound monitoring~     until ovulation triggering.~   "
36518|NCT03088618|"~     The purpose of this clinical trial is to evaluate safety and efficacy of TnR mesh for~     patients who need nasal septoplasty for septal deformity with nasal obstruction.~   "
36519|NCT03088605|"~     In subjects with Dry Eye Syndrome:~      The primary objective of this study is to compare the safety and tolerability of TOP1630~     Ophthalmic Solution to placebo.~      The secondary objectives are to compare the efficacy of TOP1630 Ophthalmic Solution to~     placebo for the treatment of the signs and symptoms of dry eye syndrome.~   "
36520|NCT03088592|"~     The pathology of Parkinson's disease (PD) and the mechanism of Deep Brain Stimulation surgery~     (DBS) are not completely understood. The recording data that is used routinely as part of the~     procedure to map the target structures, however, may be analyzed in order to better~     understand the neural network dynamics in PD. The purpose of the study is to perform~     simultaneous neural recordings from sub-cortical structures (e.g. subthalamic nucleus [STN]~     or globus pallidus internus [GPi]) and the cerebral cortex. These simultaneous recordings may~     provide insight in the pathology of PD and the mechanism of DBS. The researchers will also~     study the effects of anesthesia level on neuron synchronization . Recordings with micro-ECoG~     grid electrodes in the cortex show improved spatial resolution and these will be used to gain~     better understanding of cortical network dynamics and the synchronization with subcortical~     structures.~   "
36521|NCT03088579|"~     The researchers recognized the possible clinical usefulness of a shielded device or jig to~     help increase the accuracy but decrease the time of loading the seeds into the biocompatible~     material used intra-operatively. Therefore, the researchers created a prototype of a device~     called the GammaTile (GT) loader (design patent pending). The reusable device will be made of~     surgical quality stainless steel of sufficient thickness (greater than 10 half-value layers~     (HVL) to provide significant staff and user shielding as well as allowing it to be~     sterilized. It is utilized intraoperatively but off of the operative field and has no direct~     patient contact. Currently two sizes are planned. The first will accommodate a 2 inch x 2~     inch collagen square and the second will accommodate a 1 inch x 1 inch collagen square. These~     are the most commonly used sizes of lyophilized collagen used in the Barrow Neurosurgical~     Institute (BNI) operating rooms (OR).~   "
38892|NCT03057626|"~     This research trial studies late effects after treatment in patients with previously~     diagnosed high-risk neuroblastoma. Studying late effects after treatment may help to decide~     which treatments for high-risk neuroblastoma are better tolerated with less side effects over~     time.~   "
36522|NCT03088566|"~     Early identification of potential risk factors for the onset of diabetic foot ulcers are~     recommended. However, in a Swedish context, there has been no standardised routines to be~     used in the foot screening procedure. In this study a new standardised routine, the D-Foot,~     will be tested at the Department of Prosthetics and Orthotics. The usability of the web~     program will be tested.~   "
36523|NCT03088553|"~     This study aims to better define the target range of ganciclovir trough concentrations by~     investigating the relationship between ganciclovir concentration and the time to undetectable~     CMV-DNA load, in preemptive and curative treatments by (val)ganciclovir.~   "
36524|NCT03088540|"~     To assess the safety and efficacy of REGN2810 as first-line treatment in patients with~     advanced or metastatic NSCLC whose tumors express PD-L1.~   "
36525|NCT03088527|"~     The primary purpose of this study is to evaluate the clinical safety profile, tolerability,~     and pharmacokinetic (PK) characteristics of RAD140 in hormone receptor positive breast~     cancer.~   "
36526|NCT03088514|"~     This study aims to determine whether dietary inorganic nitrate (in beetroot juice) is able to~     reduce overall thickening of the heart (left ventricular hypertrophy or LVH) and stiffness of~     the arteries when given to patients with persistently raised blood pressure (hypertension).~     Half the patients will receive the beetroot juice containing inorganic nitrate and half will~     receive beetroot juice from which the inorganic nitrate has been removed. The volunteers will~     take the juice every day for 4 months.~   "
36527|NCT03088501|"~     MAASTHI (Maternal Antecedents of Adiposity Studying the Transgenerational role of~     Hyperglycaemia and Insulin) is a prospective birth cohort with the aim of assessing the~     effects of glucose levels in pregnancy on the risk of adverse infant outcomes, especially in~     predicting the possible risk markers of later chronic diseases. The recruitment of the~     pregnant women in MAASTHI has begun in the month of April 2016. Of the eligible pregnant~     women only 77% completed the oral glucose tolerance tests.The follow ups of mother and child~     are conducted at birth and annually during the year 1, 2, 3 and 4 of the child. Despite~     stringent adherence of including only the residents of the source population, nearly 13% of~     the women were lost to follow-ups at birth. In order to prevent further loss to follow-ups in~     subsequent visits, the investigators aim to explore whether interventions involving~     innovative Interactive Voice Response System (IVRS) and conducting mother and baby workshops~     can improve in the number pf women undergoing lab tests and subsequent follow-ups.~   "
36528|NCT03088488|"~     Vitamin D has become important for periodontal disease due to play a role in autoimmunity,~     bone mineral metabolism and inflammation. Our aim was to investigate the relation between~     serum 25-hydroxy vitamin D levels, clinical periodontal parameters and blood serum~     biomarkers. The subjects were evaluated in 2 groups as chronic periodontitis (n= 30) and~     periodontally healthy subjects (n= 30). Periodontal parameters and fasting venous blood~     samples were taken from the subjects to assess each patient's periodontal status and for~     biochemical analyses (25-hydroxy vitamin D (25-OH vit D), osteoprotegerin (OPG), receptor~     activator of nuclear kappa B ligand (RANKL), C-telopeptide (CTx), tumor necrosis factor-α~     (TNF-α)).~   "
36529|NCT03088475|"~     Aim. To develop and compare a nurse-led smartphone-based self-management programme with an~     existing nurse-led diabetes service on health-related outcomes of type 2 diabetes patients~     with poor glycaemic control in Singapore.~      Background. Over the past decades, Asia has emerged as the 'diabetes epicentre' in the world~     due to rapid economic development, urbanisation, and nutrition transition. There is an urgent~     need to develop more effective care management strategies in response to this rising diabetes~     epidemic.~      Design. A randomised controlled trial with pre- and repeated post-tests control group design.~      Methodology. A total of 128 type 2 diabetes patients with poor glycaemic control will be~     recruited from the diabetes clinic of a public acute hospital in Singapore through~     convenience sampling. Study participants will be randomly allocated either to the~     experimental group or the control group. Outcome measures will include the 10-item General~     Self-Efficacy Scale, 11-item Revised Summary of Diabetes Self-care Activities, and 19-item~     Diabetes-Dependent Quality of Life. Data will be collected at three time points: baseline, 3~     months, and 6 months from the baseline.~      Discussion. It is expected that this programme will be an alternative offered to diabetes~     patients to master their self-care management skills, in addition to the existing diabetes~     service provided in diabetes clinics in Singapore hospitals. Furthermore, the self-supporting~     and less resource-intensive nature of this programme, through the use of a smartphone~     application as the mode of intervention delivery, will greatly reduce nurses' direct contact~     time with patients and allow more time to be allocated to those who require more attention.~   "
36530|NCT03088462|"~     LiveWell is a study evaluating the use of smartphones to better understand and improve the~     treatment of bipolar disorder. Our goal is to increase access to psychosocial interventions~     and improve their effectiveness in reducing symptoms and preventing mood episodes.~   "
36531|NCT03088449|"~     To develop a cost-effective, individualised anti-TNF treatment strategy for patients with~     Crohn's disease which maximizes benefit and minimises harm.~      The primary objective of this study is to investigate the mechanisms that underlie primary~     non-response (PNR), loss of response (LOR) and adverse drug reactions (ADRs) to anti-TNF~     drugs in patients with active luminal Crohn's disease.~   "
36532|NCT03088436|"~     The aim of the present study was to determine the prone-to-supine displacement of breast~     lesions using preoperative prone MRI and supine second-look ultrasound data~   "
36533|NCT03088423|"~     The aim of this work was to describe SBRT different presentations, to study predictive~     factors for tumor responses following treatment, and to compare tumor response assessments~     according to the Response Evaluation Criteria~   "
36534|NCT03088410|"~     The purpose of this study is to assess the early longitudinal metabolic effects including~     insulin sensitivity in HIV-exposed uninfected (HEU) children compared to HIV-unexposed~     uninfected (HUU) children; as well as to determine differences in the effects of neonatal~     zidovudine (AZT) vs. nevirapine (NVP) prophylaxis on early longitudinal changes in insulin~     sensitivity in the first 3 years of life.~   "
36655|NCT03086811|"~     Rise in childhood obesity and poor eating habits and eating problems is apparent over the~     last decades. Parents are at lose what the correct way to tackle these problems may be. This~     study examined whether professional behavioral and nutritional training of first time mothers~     improves feeding relationship and infants eating habits at 12 months.~   "
36535|NCT03088397|"~     Effective physician-patient communication in postpartum contraceptive counseling is essential~     for patients to meet their contraceptive needs and reduce the risk of rapid repeat~     pregnancies. This project will utilize a patient decision aid to facilitate shared decision~     making in the immediate postpartum setting, assess the effectiveness of such aid in decision~     quality and decision-making process quality, and observe its effects on contraceptive~     choice mix at the time of discharge.~   "
36536|NCT03088384|"~     Klarisana is conducting an observational study in San Antonio, Texas to see if there are~     tangible improvements in the symptoms of post traumatic stress disorder (PTSD) in combat~     veterans after receiving a series of six low-dose outpatient infusions of ketamine.~   "
36537|NCT03088371|"~     Objectives: To compare the efficacy of continuous combined psoas sciatic block as a sole~     anaesthetic technique with conventional combined spinal epidural anesthesia for patients~     undergoing total knee arthroplasty.~      Subjects and Method: Eighty patients ASA (American society of anaesthesiologists~     classification) I to III with age range from 50 to 65 years old and scheduled for total knee~     replacement were included in the study. Subjects were divided into two groups; the first~     group (Pso/sci) received ultrasound guided with the use of nerve locator continuous psoas~     sciatic block and the second group (CSE) received combined spinal epidural anesthesia. Onset~     of sensory and motor block time, hemodynamic changes, contra-lateral spread, first time need~     for analgesia, incidence of complications, and patient and surgeon satisfactions were~     recorded.~   "
36538|NCT03088358|"~     To evaluate influence of therapy on the following efficacy and safety parameters in different~     TeaRx dose groups and Enoxaparin group:~        -  Total venous thromboembolic events (VTE), which includes confirmed deep venous~          thrombosis (DVT), nonfatal pulmonary embolism (PE), and total mortality~        -  Incidence of DVT (total, proximal, distal)~        -  Incidence of nonfatal PE~        -  Incidence of symptomatic VTE (DVT, PE)~        -  VTE caused mortality~        -  Non-VTE caused mortality~        -  Incidence of all hemorrhagic complications~        -  Incidence of major and clinically relevant non-major bleeding~        -  Adverse events (AEs) and serious adverse events (SAEs) from subject complaints, physical~          examination, vital signs, laboratory results~   "
36539|NCT03088345|"~     This is an investigator initiated, prospective, single-center, double-blinded, randomized,~     placebo-controlled trial of post-operative low dose vasopressin infusions as an early~     treatment of low systemic perfusion in pediatric patients following Fontan palliation.~   "
36540|NCT03088332|"~     Obesity is a chronic disease that has grown to epidemic characteristics in Brazil and around~     the world in recent years. Treatment for patients with class III or class II obesity with~     comorbidities is already well established, with bariatric surgery being the best option.~     However, there is no consensus as to the best treatment for cases of class I and class II~     obesity without comorbidities. The objective of this research will be to make a gastric tube~     similar to that obtained in surgical gastroplication however it will be created using~     intragastric endoscopic sutures. The procedures will be performed at the Endoscopy Service of~     the Mario Covas Hospital in São Paulo, SP. Data collection will be performed at the same~     location.~   "
36541|NCT03088319|"~     The risk of emergence of a post natal depression is based on an interaction between a~     maternal psychic vulnerability and a chronic environmental context of stress. The PND appears~     as a relevant model for studying the mechanisms of chronic stress and vulnerability to~     psychological pathologies.~      This study aim to follow a cohort of pregnant women to determine the predictive~     psychobiological factors of the emergence of postnatal depression~   "
36542|NCT03088306|"~     Patients presenting for lumbar spine surgery experience pain related to their spine~     condition. Following surgery, these patients also experience surgical pain resulting from~     disruption of skin, muscle tissue, vertebrae, intervertebral discs, and facet joints. This~     pain is often treated with opioid medications - with roughly 40% of patient experiencing~     sub-optimal pain management. Adequate pain control has become a top priority among~     professional societies, healthcare systems, and accrediting agencies. The current proposal~     will provide this critical evidence of feasibility and acceptability of a multi-modal pain~     management plan for patients undergoing lumbar spine surgery. Additionally, this study will~     provide critical preliminary data to compare the effectiveness of protocol-driven multi-modal~     pain management to control post-operative pain, reduce opioid medication use, and improve~     physical activity, sleep, and health.~   "
36543|NCT03088293|"~     This study will evaluate the Efficacy and Safety of Infliximab versus Cyclophosphamide in~     Subjects with Idiopathic Refractory Scleritis.~      The term scleritis describes a chronic inflammation that involves the outermost cost and~     skeleton of the eye. Scleritis is classified anatomically as either anterior or posterior~     based on the principal location of the inflammation. Thirty to forty percent of scleritis~     cases are associated with systemic autoimmune conditions including rheumatoid arthritis and~     granulomatosis with polyangiitis. Infectious causes including herpes virus and varicella~     zoster account for 5 to 10% of patients. The remaining 50% of cases are classified as~     idiopathic.~      CIRIS, is the first prospective randomized, head to head study, comparing infliximab to~     cyclophosphamide in refractory idiopathic scleritis. There is no firm evidence or randomized~     controlled trials directly addressing the best biologic agent in severe and refractory~     idiopathic scleritis. If left untreated or insufficiently treated, scleritis can progress to~     peripheral ulcerative keratitis, uveitis and glaucoma. Visual loss occurs in approximately~     10% of patients with anterior scleritis and in up to 75% of patients with posterior~     scleritis. The incidence of burden in ocular inflammation (uveitis and scleritis) has been~     dramatically reduced in the recent years with the use of biologics, raising the question of~     whether these compounds should be used earlier in the treatment of severe non infectious~     scleritis. Contrasting with other immunosuppressors, cyclophosphamide and infliximab act~     rapidly and are highly effective in steroid's sparing.~      Despite a strong rationale, these compounds are not yet approved in idiopathic refractory~     scleritis, which guarantees the innovative nature of this study that aims selecting or~     dropping any arm when evidence of efficacy already exists.~   "
36544|NCT03088280|"~     Single-center, prospective, randomized, open-label clinical trial to evaluate the 1-year~     efficacy and safety of rATG 3mg/kg compared to 6mg/kg in low to moderate immunological risk~     patients receiving low exposure tacrolimus plus everolimus (EVL) in a steroid-free protocol.~   "
36545|NCT03088267|"~     This is a randomized, double-blind, two treatment, two sequence, placebo-controlled crossover~     study to assess the efficacy and safety of dose Dyanavel XR in reducing signs and symptoms of~     ADHD compared with placebo in pediatric subjects ages 6 to 12 years with ADHD.~   "
36546|NCT03088254|"~     To evaluate efficacy and safety of co-administrated temisartan/amlodipine and rosuvastatin in~     subjects with dyslipidemia with hypertension.~   "
36656|NCT03086798|"~     to investigate the effectiveness of techniques of either using Magill forceps or cuff~     inflation in facilitation of nasotracheal tube advancement into trachea~   "
36547|NCT03088241|"~     This trial addresses the question of the viral load (VL) threshold for switching from~     first-line to second-line antiretroviral therapy (ART). The WHO currently sets the threshold~     at 1000 copies/mL. However, the optimal threshold for defining virological failure and the~     need to switch ART regimen has not been determined. In fact, people with VL levels of less~     than 1000 copies/mL, however, not fully suppressed, are at increased risk for drug resistance~     mutations (DRM) and subsequent virological failure. In resource-limited settings where VL~     monitoring is not as frequent as in high-income countries, this could have serious~     implications and patients may continue on a failing regimen for a long period. Our research~     consortium will conduct a multicenter, parallel-group, open-label, randomized clinical trial~     in a resource-limited setting to assess whether a threshold of 100 copies/mL compared to the~     WHO-defined threshold of 1000 copies/mL for switching to second-line ART among unsuppressed~     HIV-positive patients on first-line ART will lead to better outcomes.~   "
36548|NCT03088228|"~     Background: The purpose of this study is to examine the relationship between maternal~     preeclampsia and periodontal parameters and the correlation of these two disorders with~     maternal gingival crevicular fluid levels (GCF) of interleukin (IL)-35, interleukin-37 and~     interleukin-6. The investigators also investigated their relation to the severity of~     preeclampsia.~      Methods: 82 preeclamptic women were recruited to the study (29 healthy pregnant women, 30~     mild preeclamptic patient, 23 severe preeclamptic patient ). The clinical periodontal~     parameters and GCF samples were collected in the first day of puerperium.~   "
36549|NCT03088215|"~     Fibromyalgia pain syndrome is a common debilitating condition which associates mainly~     generalised pain, emotional distress and cognitive symptoms. The etiology is unknown, and no~     specific treatment exists so far.~      Lately, shock-waves have been used successfully to treat painful skeletal muscle, tendons and~     fascia, the investigators therefore hypothesize that shock-waves could be useful in~     alleviating Fibromyalgia pain.~      Two similar groups of participants bearing the condition will be prospectively compared.~      The first group will benefit from the application of shock-waves weekly for 12 weeks, the~     second will not.~      The investigators intend to study if there is any difference in pain and quality of life~     between the two groups at the end of the three months.~   "
36550|NCT03088202|"~     A major concern in today's oncology is the complexity of treatment that increases costs. A~     main contributor is the increasing use of chemo- and radiotherapy during end of life (EoL:~     the last 12 months of life). Importantly, intensive chemotherapy in EoL has uncertain~     efficacy, may result in frequent hospitalizations and less time spent at home. Also, patients~     with incurable disease who receive intensive treatment at EoL have worse quality of life~     (QoL). A systematic palliative care (PC) approach that focuses on optimal symptom management~     and maintenance of QoL of patients and family is often introduced too late in the disease~     trajectory. Studies indicate that early introduction of PC in patients with unfavorable~     prognosis may improve QoL and other symptoms and prolong survival. These and related findings~     have made international stakeholders advocate a stronger integration of oncology and PC for~     patients with incurable cancer.~      The present project is a national multicenter cluster-randomized trial (RCT) in 12 oncology~     departments in all 4 Norwegian health regions. The project tests the efficacy of a complex~     tripod intervention that integrates oncology and PC for cancer patients with a~     life-expectancy <12 months who receive chemotherapy and includes: A) systematic electronic~     assessment of symptoms, B) implementation of standardized care pathways and C) an education~     program for oncologists/PC physicians. The PC pathway focuses on the patient's journey~     through the PC trajectory including EoL care in order to improve quality of care and reduce~     the variability in clinical practice and costs. The intervention aims at empowering~     physicians, patients and relatives and promoting shared-decision-making.~   "
36551|NCT03088189|"~     Maternal nutrition is an important factor which determines fetal growth and development.~     Micronutrients vitamin B12 and folic acid are essential determinants of one carbon metabolism~     and play an important role in DNA synthesis, methylation and epigenetic regulation of gene~     expression. Diabetes unit of KEMHRC, Pune has been conducting the Pune Rural Intervention in~     Young Adolescents since last 3 years. Subjects of the PMNS cohort have been randomized as~     part of a controlled trial of nutritional intervention with vitamin B12 vs multiple~     micronutrient and milk protein vs placebo. This study aims to understand the~     intergenerational effects of vitamin B12 supplementation. 74 infants have been born in this~     trial since 2013. This study would assess neurocognitive development of offspring born to~     mothers who are part of the nutritional intervention trial; on the Bayley scales of infant~     and toddler development - III. The study aims to test the hypothesis that infants born to~     mothers who received vitamin B12 would have favorable infant neurocognitive development~     scores as compared to placebo. And this effect would be enhanced in the group whose mothers~     received MMN with milk protein.~   "
36552|NCT03088176|"~     The purpose of the study is to determine safety and tolerability of the combination of~     talimogene laherparepvec in combination with dabrafenib and trametinib in BRAF mutated~     advanced melanoma.~   "
36553|NCT03088163|"~     The study is designed to evaluate the value of DWI-MRI (Diffusion weighted magnetic resonance~     imaging) in predicting the efficacy of liver metastases after chemotherapy in colorectal~     cancer.~   "
36554|NCT03088150|"~     The primary objective is to prove non-inferiority of thermal ablation compared to hepatic~     resection in patients with at least one resectable and ablatable colorectal liver metastases~     (≤3cm) and no extrahepatic disease.~   "
36555|NCT03088137|"~     The purpose of this study is to show equivalence with regard to the number of oocytes~     retrieved between follitropin alfa (pen-injectors) Primapur® and Gonal-f® in woman undergoing~     IVF/ICSI~   "
36556|NCT03088124|"~     Many prostate cancer are slow or non progressive forms that would never impair quality or~     quantity of like of life if undetected. For this localized prostate cancer, the~     recommendation is an active surveillance, however often experienced by the patient as a lack~     of care. Thus the introduction of new potent androgen receptor inhibitor raise the question~     of the benefit of early hormonal therapy in localized prostate cancers.~      The aim of this study is to assess whether treatment with an oral androgen receptor inhibitor~     could influence the progression of localized prostate cancer and delay the time to local~     treatment initiation.~   "
36657|NCT03086785|"~     The purpose of this study is to assess the efficacy and safety of patients who receive~     apatinib single or combined capecitabine for treatment of patients with metastatic her-2~     negative breast cancer.~   "
36557|NCT03088111|"~     This field study is a post-marketing requirement from the FDA to evaluate the clinical~     benefit (course of illness and survival), safety and pharmacokinetics of obiltoxaximab~     administered to patients as part of their medical care for treatment or prophylaxis of~     inhalational anthrax infection following exposure to Bacillus anthracis (B. anthracis). The~     protocol can be implemented for any individual who receives obiltoxaximab for a suspected,~     probable, or confirmed case of inhalational anthrax due to B. anthracis in the United States,~     including sporadic cases, small incidents and/or a mass event. In case of a small anthrax~     incident, to the extent possible, the information will be collected prospectively at~     prespecified time points, except where it would interfere with management of the subject's~     illness. However, because of the logistical complexities that would likely accompany a mass~     anthrax event, most data in this study are anticipated to be collected retrospectively. Both~     retrospective and prospective data collection are allowed to maximize information collection.~     This study will collect data on the use of obiltoxaximab in anthrax infected or exposed~     subjects and the data collected will inform the understanding of the clinical benefit and~     safety of obiltoxaximab.~   "
36558|NCT03088098|"~     Study category and Rationale Clinical study, Category A.~      Clinical Phase: Post market study~      Background and Rationale: Left atrial appendage occlusion (LAAO) allows avoiding oral~     anticoagulation and provides at the same time an at least equally good protection from~     strokes and peripheral embolism. It may therefore be an attractive alternative to oral~     anticoagulation in the patient population undergoing transcatheter aortic valve implantation~     (TAVI): the concept of LAAO is based on the fact that thrombus formation in atrial~     fibrillation occurs in >90% in the left atrial appendage (LAA). Mechanical occlusion of the~     LAA reduces the stroke risk by eliminating the source of thrombus formation. In the here~     proposed Randomized Comparison of Left Atrial Appendage Occlusion versus Standard Medical~     Therapy in Patients in Atrial Fibrillation Undergoing Transfemoral Transcatheter Aortic Valve~     Implantation, study we test the hypothesis, that LAAO is superior to standard medical~     therapy in the high-risk TAVI population. This hypothesis has not been investigated by~     previous studies so far.~      Overall Objective(s): Overall objective: to compare the safety (and efficacy) of LAAO using~     the St. Jude left atrial appendage closure device with standard medical therapy in a~     prospective, multi-center, randomized trial in patients undergoing TAVI in routine clinical~     practice.~      Primary Objective: To assess the safety of the device intervention with regard to stroke~     prevention and prevention of bleeding complications in a patients population at high risk of~     stroke and bleeding.~      Secondary Objectives: Short-term (procedural) safety of device intervention is assessed (rate~     of successful deployment of a left atrial appendage occluder; rate of kidney failure). As a~     further secondary objective, long-term effects of device intervention on stroke and bleeding~     prevention as well as mortality are assessed and compared to medical therapy.~      Outcome(s): Primary: Composite endpoint of ischemic and hemorrhagic neurologic events,~     peripheral embolism, life-threatening/disabling and major bleeding complications and~     cardiovascular mortality at 1 year~      Secondary: All deaths (cardiac and non-cardiac) at 30 days, 1, 3, and 5 years Device success~     at 30 days~      In-hospital acute kidney injury (AKI)~      Study design: An investigator-initiated, randomized, multicenter, non-blinded, all-comers~     study~      Measurements and Procedures: 80 patients in atrial fibrillation undergoing TAVI will be~     randomized in a non-blinded fashion (1:1 randomization) to LAAO (device group) or SMT at the~     operators' discretion (medical group; antiplatelet therapy and oral anticoagulation or oral~     anticoagulation alone). All patients will be followed for up to 5 years. The primary analysis~     will be performed at 30 days and after completion of a 1-year follow-up.~      80 patients in atrial fibrillation undergoing TAVI will be randomized in a non-blinded~     fashion (1:1 randomization) to LAAO (device group) or standard medical therapy (SMT) at the~     operators' discretion (medical group; antiplatelet therapy, oral anticoagulation or oral~     anticoagulation alone).~      Estimated duration for the main investigational plan from start of screening of first~     participant to last participant processed and finishing the study: 6 years~   "
36559|NCT03088085|"~     This project aims to study the impacts of self-thoracic spine and rib mobilization on sleep~     quality in patients who present to UTSW physicians with shoulder pain. The investigators plan~     to randomize participants into treatment and control groups, but the investigators will~     provide education on sleep hygiene for each group. The treatment group will also receive~     instruction to mobilize their thoracic spine and ribs each night before going to sleep.~   "
36560|NCT03088072|"~     This is a single arm, open label, single site study assessing the feasibility of~     post-procedural edoxaban therapy in atrial fibrillation (AF) patients after clinically~     indicated WATCHMAN left atrial appendage (LAA) closure.~   "
36561|NCT03088059|"~     This is a biomarker-driven trial that will enroll patients with recurrent or metastatic~     squamous cell carcinoma of the head and neck progressing after first-line platinum-based~     chemotherapy. Based on potential biomarkers and molecular alterations identified in the~     biopsy from the central platform, patients will be allocated in different cohorts. There will~     be biomarker-positive patient cohorts and immunotherapy cohorts.~   "
36562|NCT03088046|"~     Hormonal evaluation of women who are suspected of having Polycystic ovary syndrome (PCOS)~     involves the measurement of basal levels of androgens and 17-hydroxyprogesterone (17-OHP),~     which are generally used to establish the presence of hyperandrogenemia. In general, these~     levels are obtained during the follicular phase to maintain sampling uniformity and avoid~     spurious increases due to corpus luteum function. However, because most hyperandrogenic~     patients are oligo/amenorrheic, it is frequently necessary to administer a progestogen to~     induce withdrawal bleeding and properly time the blood sampling.~      Several medications have been described to properly induce withdrawal bleeding , with~     medroxyprogesterone acetate (MPA) being the most widely use. However, synthetic compounds as~     MPA do not replicate precisely the constellation of biologic activities of the parent hormone~     and results in a temporary, albeit clinically relevant, suppression in ovarian function and~     circulating androgen levels , in addition of several adverse side effects .~      In this study, it is hypothesized that the administration of natural progesterone vaginally,~     which will avoid hepatic first pass, may result in significantly less hormonal suppression.~      The authors test this hypothesis by prospectively determining the effect of vaginal~     micronized progesterone (OMP), administered for the induction of withdrawal bleeding, on the~     circulating androgen and 17-OHP levels in women with PCOS.~   "
36563|NCT03088033|"~     Multicenter, Prospective, Randomized Controlled, Blinded Trial, with a Non-implant Control~     group; 1:1 randomization.~   "
36564|NCT03088020|"~     The Center for Autonomic Medicine in Pediatrics (CAMP) has built the first International CCHS~     (Congenital Central Hypoventilation Syndrome REDCap (Research Electronic Data Capture)~     Registry. This registry is an international collaboration with CCHS patients and their~     physicians recruited from around the world.~      The purpose of this IRB-approved research study is to gain a better understanding of the~     various clinical manifestations of CCHS with advancing age, and as related to each patient's~     specific PHOX2B mutation. With a better understanding of specific CCHS PHOX2B mutations and~     associated disease manifestations, we will be able to better anticipate healthcare needs and~     to provide more accurate guidelines to healthcare providers world-wide in caring for patients~     with CCHS.~      The study aims to obtain detailed phenotypic information (information about health and~     well-being) on patients with CCHS. Participation would require filling out a confidential~     survey that asks questions regarding phenotype and past medical history. Involvement in the~     project is completely voluntary and there is no compensation for taking part. However, this~     project will help us learn more about this devastating disease, with the goal of advancing~     treatment.~   "
36565|NCT03088007|"~     The EVAL'ID study aims to demonstrate the value of a multidimensional assessment in~     accompanying schooling of children with Intellectual Disability. The study will be performed~     in the Rhône department (France) in children aged from 5 to 13 years with mild to moderate~     Intellectual Disability , and attending school either at ULIS (Unités Localisées pour~     l'Inclusion Scolaire, which enables disabled children to attend regular schools), or IME~     (Instituts Médico-Educatifs, which are special schools mandated to accommodate children and~     young people with Intellectual Disability at any level of disability). A multidimensional~     assessment encompasses the assessment of academic, cognitive, behavioral and adaptive skills~     of the children, with validated and reliable neuropsychological batteries, called ID Kit~     (Intellectual Deficiency assessment Kit), which includes the following scales : the Wechsler~     Intelligence Scale for Children 4th edition (WISC-IV), the Vineland Adaptive Behavioral Scale~     II, the GECEN rating form (Grille d'Evaluation Comportementale pour Enfants Nisonger, which~     is the French translation of the Nisonger Child Behavior Rating Form), and an academic skills~     rating form (GEVA-SCO). A comparison of the children neuropsychological profiles according to~     the type of school they attend, will be perform.~      The project consists of three phases:~        -  Stage 1: Collection of information from each child records at MDPH (Departmental~          Administration for Disabled Persons), IME, ULIS schools, including the assessments that~          were performed, and from a survey of both caregivers and parents regarding their~          respective perception and knowledge of the child's disability~        -  Stage 2: All the children who were not previously assessed with the ID kit will be~          further evaluated using these tests. The results of these assessments will be shared~          with parents and caregivers.~        -  Stage 3: A survey regarding the perception and knowledge of the child's disability will~          be carried out again among caregivers and parents.~   "
36566|NCT03087994|"~     The proposed study is a randomized, open, comparative research involving an intervention~     group and two control groups.~      The aims of the study are: 1.To compare levels of depression in female adolescents with~     obesity and a control group of female adolescents with appropriate weight and height. 2. To~     investigate whether a decrease in weight due to a short range intervention program provided~     by dietician for female adolescents with obesity will lead to change in the levels of~     symptoms of depression and cognitive and executive functions in comparison to a control group~     of adolescent girls with obesity, matched in age that does not receive such an intervention~     program.~      60 Female adolescents with obesity will be recruited to the study and will be randomized to 1~     of two groups- 1. intervention group- participants in this group will attend an intervention~     program consisting of 12 meetings with dietician and will attend three study visits at the~     clinic- in the beginning of the study, after three months and at the end of the study after a~     year. 2.Control group- Participants in this group will only come to three study visits at the~     clinic. In the first two visits they will meet with a dietician and will receive nutrition~     guidance and hypo-caloric menu.~      Another 30 girls with appropriate weight will be recruited to second control group- this~     group will come to three study visits at the clinic- in the beginning of the study, after~     three months and at the end of the study after a year. In the first two visits participants~     will receive nutrition guidance by the dietician.~      In the study visits the following procedures will be performed for all study groups: Blood~     tests, completion of psychological and nutritional questionnaires, completion of computerized~     tests and measurements of height, weight, fat mass and circumference of hips.~   "
36567|NCT03087981|"~     The PANDA trial is a multicenter prospective observational study designed to analyze various~     ICP derived parameters and clinical status in neurosurgical critical patients through a new~     big data acquisition system.~   "
36568|NCT03087968|"~     This clinical investigation is a substudy within GS-US-416-2124, IND 129570, which is A Phase~     2, Double-Blind, Randomized Study Evaluating the Safety, Tolerability, and Efficacy of~     GS-4997 in Combination with Prednisolone versus Prednisolone Alone in Subjects with Severe~     Alcoholic Hepatitis. The use of the HepQuant SHUNT test is to assess liver disease severity~     before, during, and after treatment with GS-4997 or placebo, to assess liver disease~     severity.~   "
36569|NCT03087955|"~     The goal of this study is to assess efficacy and safety of SCYX-7158 given as a single dose~     oral treatment for adult patients (above or equal 15) in the fasting state with T.b.~     Gambiense HAT~   "
36570|NCT03087942|"~     The aim of the study is to assess whether renal impairment could affect fevipiprant~     pharmacokinetics (PK) to the extent that dosage adjustment is appropriate for this patient~     population.~      The study also aims to determine the effect of dialysis on the fevipiprant pharmacokinetic~     profile as the procedure might remove a significant fraction of the drug.~   "
36571|NCT03087929|"~     A previous phase II trial entitled Treatment of Follicular non-Hodgkin's Lymphoma with High~     Dose Therapy and Stem Cell Support Followed by Consolidative Immunotherapy with Rituximab and~     Alpha Interferon was conducted at the Odette Cancer Centre between 2005 and 2012. The primary~     objectives of this previous trial was to assess progression free survival and overall~     survival. Of the 36 patients in this trial, approximately 18 remain in remission. In this new~     follow up trial, follow up data will prospectively be collected on patients who provide~     informed consent to do so.~   "
36572|NCT03087903|"~     Patients will take 150 mg of GSE product by mouth twice daily and will be evaluated every 6~     weeks for 3 months, then every 3 months thereafter for up to one year.~   "
36573|NCT03087890|"~     Cotrimoxazole preventive therapy (CPT) is recommended for prevention of morbidity and~     mortality due to Pneumocystis pneumonia and other infections in HIV positive patients with~     low immunity. Common clinical practice is to start CPT in any patient with CD4 counts below~     200/µL, and, conversely, to stop CPT when immunity has been restored by antiretroviral~     treatment to CD4 counts above 200/µL or when viral suppression has been documented for 3~     months. However, the latest WHO guidelines widely expands the indication for CPT by~     advocating for settings with high prevalence of malaria and bacterial infections, that all~     patients with HIV start CPT regardless of CD4 counts and clinical stage. Furthermore, WHO~     recommends these patients to continue CPT indefinitely regardless of evidence of immune~     restoration (The recommendation is for settings with high prevalence of malaria and bacterial~     infections, not for high-income countries). There is limited scientific evidence to recommend~     prolonged CPT, as studies have shown it is associated with modestly reduced morbidity due to~     pneumonia, meningitis and malaria, but no corresponding reduction in mortality. The impact of~     such a large increase in antibiotic use on the emergence of antimicrobial resistance has not~     been thoroughly considered. Our previous studies in Tanzania showed that multidrug-resistant~     bacteria frequently cause bloodstream infections with resultant very high case-fatality~     rates. As genes encoding for multiple antibiotic resistance traits are transferred by~     plasmids together with resistance towards cotrimoxazole, prolonged CPT will likely favor the~     selection of carriage of multidrug-resistant gut bacteria. The proposed randomized clinical~     trial is designed to assess whether prolonged CPT in HIV-positive patients results in~     increased fecal carriage of multi-drug resistant gut microbes or increased nasal carriage of~     methicillin-resistant Staphylococcus aureus (MRSA). Secondary endpoints are morbidity~     (clinical events, hospitalizations) and mortality. Stool specimens, nasal swabs and clinical~     data will be collected from persons attending voluntary counseling and testing facilities and~     HIV-clinics in Dar es Salaam, Tanzania. The study results may have important impact on public~     health in terms of assisting development of rational recommendations for CPT use, and may~     help prevent emerging antibiotic resistance.~   "
36574|NCT03087864|"~     Objectives The primary objective of this study is to assess the feasibility of preoperative~     treatment with atezolizumab combined with preoperative chemoradiation (carboplatin,~     paclitaxel and radiation) in terms of completion of treatment with atezolizumab.~   "
36575|NCT03087851|"~     Denosumab is an antibody against receptor-activator of nuclear factor kappa-B ligand that~     prevents recruitment and differentiation of mature osteoclasts. Treatment markedly decrease~     bone resorption and fracture risk, and many patients will reach osteopenic BMD levels on~     treatment with denosumab. The treatment effect on bone turnover and BMD has, however, been~     demonstrated to be reversible. This study will show if the bone mass can be maintained by~     administrating zoledronic acid and if timing of the first dose of zoledronic acid after last~     dose of denosumab matters.~   "
36576|NCT03087838|"~     Postoperative delirium may result in many adverse complications. At present little is known~     about postoperative delirium in patients after crniotomy because they may manifest similar~     symptoms to definitely delirium for some structural brain disease. Objective of this study is~     to find out incidence and risk factors of postoperative delirium in patients after elective~     craniotomy and also the relationship of postoperative delirium with clinical outcome.~   "
36577|NCT03087825|"~     During preoxygenation, imperfect seal between the face mask and patient's face can induce an~     inward air leak decreasing its effectiveness. We assume that noninvasive ventilation could~     cancel the effect of the leak.~      This is a prospective study. Healthy volunteers are randomised in cross-over between~     spontaneous breathing or noninvasive ventilation pressure support preoxygenation in the~     presence or absence of a calibrated leak on the inspiratory circuit.~   "
36578|NCT03087812|"~     This is an observational study in which data on consecutive patients who undergo~     ureterorenoscopy with the use of a flexible ureterorenoscope are collected. In total 20 new~     ureteroscopes are usedfrom Olympus andfrom Storz) to study the durability of the~     ureteroscopes and the possible microbiological load.~   "
36579|NCT03087799|"~     Patients with Irritable Bowel Syndrome (IBS) often report more fatigue and sleep disturbances~     compared to their healthy counterparts and compared to patients with other GI disorders. This~     pilot study will evaluate the feasibility of a Brief Behavioral Treatment for Insomnia~     (BBT-I) in Irritable Bowel Syndrome. 40 participants will be recruited; 20 will receive 4~     weeks of BBT and 20 will be assigned to a wait list control group (WLC). The primary aim of~     the current project is to assess feasibility of administering BBT-I to a sample of patients~     with IBS. Because behavioral sleep treatment has not yet been studied in IBS or any other GI~     population, this project will provide information about treatment adherence, recruitment, and~     effect sizes. Secondary aims include evaluating the impact of BBT-I on sleep quality and IBS~     symptom severity.~   "
36580|NCT03087786|"~     To study the oral mucosal effects in adult smokers associated with the use of two Nicotine~     Lozenge formulations.~   "
36581|NCT03087773|"~     This study is planned to investigate the impact of Empagliflozin on biomarkers of heart~     failure in patients with myocardial infarction with and without type 2 diabetes mellitus~     within 6 months after the event.~   "
36582|NCT03087760|"~     The main purpose of this study is to assess the safety, tolerability and anti-tumor activity~     of the experimental study drug pembrolizumab (also known as Keytruda or MK-3475) in people~     with non-small cell lung cancer (NSCLC) that has come back after radiation therapy.~   "
36583|NCT03087747|"~     In a setting of acute cholecystitis (AC) one of the treatment option is percutaneous~     transhepatic cholangiography (PTHC) drainage. The goal of current study is to evaluate some~     radiology aspects and correlate with clinical patient outcomes in patients with acute~     cholecystitis severity grade III (presented as acute cholecystitis with organ dysfunction).~   "
36584|NCT03087734|"~     Pectus excavatum (PE) is the most common deformity of the chest wall, occurring in~     approximately 1/1000 people. Currently, surgical treatment by minimally invasive technique is~     consolidating as preferred technique for the treatment of this condition. In this technique a~     metal bar is inserted in retrosternal position, pushing the sternum without the necessity of~     resecting the condral cartilages. Despite the advantages obtained with this technique, it is~     not without complications and the displacement of the bar is one of the most important. In~     order to minimize this problem we developed a new model of stabilizers, as well as all~     necessary instruments for performing minimally invasive surgery. The aim of this study is to~     compare two surgical groups, one making use of the new oblique stabilizer compared to the~     conventional perpendicular stabilizer to determine which one has less displacement.~     Furthermore, this study also aims to assess the full range of instruments developed by a~     national company, to carry out this type of surgery, which has cost compatible with our~     economic reality, and that can be accessible to our Public Health patients.~   "
36585|NCT03087721|"~     The primary objective of the study is to compare the efficacy of an intervention with~     high-intensity interval, low volume training (HIIT-LV) or continuous aerobic exercise (CAE)~     on insulin resistance, insulin sensitivity and percentage of pancreatic β-cell function in~     adults with metabolic syndrome (MS).~      The secondary objective is to compare the efficacy of an intervention with HIIT-LV or CAE on~     glycosylated hemoglobin, mass and muscle fibre type composition of right thigh and plasma~     levels of musclin and apelin in adults with MS.~      The investigators hypothesized that HIIT-LV is more effective in decreasing insulin~     resistance and glycosylated hemoglobin and plasma concentrations of musclin and increasing~     plasma concentrations of apelin, and both mass and muscle fibre type I percentage in thigh,~     than CAE.~   "
36586|NCT03087708|"~     This randomized pilot clinical trial studies the side effects and best dose of naloxegol and~     to see how well it works in treating patients with stage IIIB-IV non-small cell lung cancer.~     Naloxegol may relieve some of the side effects of opioid pain medication and fight off future~     growth in the cancer.~   "
36587|NCT03087695|"~     Epstein-Barr virus (EBV) has been proven to process a strong association in patient of~     nasopharyngeal carcinoma (NPC). Monitoring plasma EBV DNA in NPC patients can provide~     reliable informations in early detecting tumor recurrence or risk grouping.~   "
36588|NCT03087682|"~     OCT is now an established way to measure the thickness of the Retinal Nerve Fiber Layer~     (RNFL) in the retina of the eye. The thickness of the RNFL is always a reflection of the~     number of the RNFs in any particular area of the retina. Each single RNF runs a long course~     starting from the cell body which is the retinal ganglion cell in the retina and ends in the~     thalamus of the brain where it relays visual information to other nerve cell in the thalamus.~     Along this long course RNFs are in close anatomical relationship with the pituitary gland~     crossing just above this gland about midway along their course. Hence enlargement of this~     gland can interfere with the RNFs.~   "
36589|NCT03087669|"~     This trial will evaluate patients with a mechanical Left Ventricular Assist Device (LVAD) in~     early stages after surgical implantation. Within the first 2 days of postoperative ICU care,~     20 patients will firstly be exposed to 4 different LVAD pump flow settings with a stable~     blood pressure. A second intervention will be mean arterial blood pressure (MAP) adjustments~     to 4 preset levels (60-70-80 and 90 mmHg) with a constant preset LVAD flow. The two~     manipulations; 1) Constant MAP with variation of LVAD flow and 2) Constant LVAD flow with~     variation of MAP, will be monitored by Central hemodynamic parameters, echocardiographic~     parameters and cerebral blood flow velocity (CBFV) parameters. The purpose of the trial is to~     find the optimal combination of LVAD pump flow, mean arterial pressure and right heart~     ventricle function for each patient. And at the same time describe the effect of flow and~     pressure variations on CBFV.~   "
36590|NCT03087656|"~     Endoscopic retrograde cholangiopancreatography (ERCP) is an endoscopic procedure used to~     treat bile duct stones, obstructive jaundice, biliary leaks, and a variety of other~     conditions.~      There is active debate whether antibiotics should be given prophylactically for ERCP outside~     of high risk indications including primary sclerosing cholangitis. In part this is due to a~     lack of appropriately powered clinical trials with adequate follow up. The aim will be to~     assess whether prophylactic antibiotics decrease the rate of post ERCP cholangitis as defined~     by the Revised Tokyo Criterion.~   "
36591|NCT03087643|"~     With aging, vascular function (VF) declines. Inactivity and sedentary life style have been~     shown to contribute to the worsening of VF. Furthermore, bed rest, a condition commonly used~     for the management of many chronic conditions, has been proven to lead to even more~     deleterious consequences, including VF decline.~      This study evaluates the effect of passive mobilization of the lower limbs on VF in bedridden~     oldest-old. Half of the participants will undergo passive mobilization treatment in addition~     to standard therapies, while the other half will receive only standard therapies. We~     hypothesize that passive mobilization may improve nitric oxide (NO)-mediated endothelial~     function.~   "
36592|NCT03087630|"~     This research examines a theoretically informed web-based personalized feedback intervention~     to reduce alcohol-related risky sexual behavior among young adult drinkers. To accomplish~     this objective the study has enrolled a national sample of 1200 young adults aged 18-20 and~     is in the process of assessing them at 3-, 6-, 9-, and 12-months. The investigators will~     evaluate the overall efficacy of the interventions based on the Prototype Willingness Model~     by comparing underage young adult drinkers randomly assigned to receive the reason-based~     pathway intervention (n=300), the social-based pathway intervention (n=300), or the~     integrated intervention based on the full Prototype Willingness Model (both pathways, n=300)~     to an attention control group (n=300). The investigators will examine whether changes in~     components of both the reasoned and social pathways and drinking mediate intervention~     efficacy on reducing alcohol-related risky sexual behavior. Past behavior and college student~     status will be evaluated as moderators of intervention efficacy. The proposed study is both~     significant and innovative in that it will evaluate brief interventions among a national~     sample of young adults attending and not attending college, will utilize social networking~     sites for participant recruitment, and will test the efficacy of interventions based on~     individual and integrated pathways of the Prototype Willingness Model.~   "
36593|NCT03087617|"~     Imbio is developing a Smoking Cessation Report (Report) that includes data analysis from a CT~     lung cancer screening exam. This randomized controlled (RCT) trial will clinically validate~     the Report's effectiveness at motivating smokers to call a Quitline.~   "
36594|NCT03087604|"~     The purpose of this randomized, observer-blinded, investigative trial is to determine if the~     use of electrical stimulation, compared to the traditional loss of resistance technique~     alone, improves the success rate of epidural catheter placement at an academic teaching~     institution.~   "
36595|NCT03087591|"~     This phase I trial studies the side effects and best dose of APN401 in treating patients with~     pancreatic cancer, colorectal cancer, or other solid tumors that have spread to other places~     in the body or have come back. APN401 may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth.~   "
36596|NCT03087578|"~     This study compares electroacupuncture to mirabegron for treatment of overactive bladder~     (OAB) symptoms in women who have failed treatment with anticholingeric therapy.~   "
36597|NCT03087565|"~     All hysterectomies were performed intrafascially using the clamp-cut-ligate method as~     described by (Jones, 2003);~      Careful examination under anesthesia.~      Catheterization by N. 18 Foley's catheter and its balloon Filled with 10-ml saline.A~     transverse lower abdominal incision (Pfannenstiel incision) ranging from 8-12 cm through~     which the abdomen is opened in layers.~      During subtotal hysterectomy procedure, the corpus is amputated just below the level of the~     isthmus and then the endocervical canal is electrocoagulated using monopolar electrocautery.~     The cervical stump is closed using vicryl 0 sutures.~      During total hysterectomy procedure, the urinary bladder is dissected off the lower uterine~     segment of the uterus and cervix by blunt or sharp dissection. Blunt dissection is done using~     a finger pushed gently against the cervix rather than against the bladder. Sharp dissection~     using Metzenbaum scissors is performed in patients with previous cesarean sections, with~     upward traction on the bladder peritoneum and the uterine fundus stretched tightly out of the~     pelvis, the tips of the Metzenbaum scissors rest lightly on the fascia overlying the cervix~     with small bites to develop a tissue plane, dissecting the bladder from the anterior cervix.~      Revision of all pedicles to ensure hemostasis.~      Intraoperative antibiotics (1 gm of a 3rd generation cephalosporin + 0.5 gm metronidazole).~      The abdomen is closed in layers; the wound is covered with a sterile dressing. All specimens~     were sent for pathological examination in the pathology Unit.~   "
36598|NCT03087552|"~     The spreading of transcatheter aortic valve implantation has paradoxically increased the~     spectrum of indications for balloon aortic valvuloplasty. Balloon aortic valvuloplasty is~     currently used as destination therapy for patients excluded from transcatheter aortic valve~     implantation, as bridge to transcatheter aortic valve implantation or to surgical aortic~     valve replacement, or as a stratification tool for selected high-risk patients who cannot be~     immediate candidates for transcatheter aortic valve implantation. Moreover, it has been~     recently showed that transcatheter aortic valve implantation without balloon aortic~     valvuloplasty is encumbered by an increased risk of cerebral embolization. However, balloon~     aortic valvuloplasty has a complication rate comparable to transcatheter aortic valve~     implantation, mainly related to access site or temporary pacemaker implantation. Thus, a~     transradial mini-invasive approach with rapid pacing through the 0,035 inch left ventricular~     support wire could be extremely appealing.~   "
36599|NCT03087539|"~     Exploratory Phase II Clinical Trial to Evaluate the Efficacy and Safety of Clotinab®~     (Abciximab) in Acute Myocardial Infarction Patients: Multicenter, Randomized, Double-Blind,~     Placebo-controlled and Parallel Group Trial~   "
36600|NCT03087526|"~     The purprose of this study is to develop and validate an analytical and clinical NIPD test~     for triplet repeat disesases by isolated circulating fetal trophoblastic cells (CFTC)~     analysis from maternal blood, searching for the familial mutation in families at risk of~     having one of the following triplet repeat diseases: Huntington's disease, Myotonic~     dystrophy, Fragile X syndrome, spinocerebellar ataxia 1, 2 and 3.~   "
36601|NCT03087513|"~     Intraoperative monitoring of the motor evoked potentials has been shown to be both a~     sensitive and specific indicator for detecting intraoperative neurologic injuries during~     spine surgery.(Fehlings, Brodke et al. 2010) It is utilised whenever there is risk for injury~     of nerve roots or the spinal cord during the procedure.~      Anaesthetic agents, especially the inhaled volatile anaesthetics and muscle relaxants, are~     confounders for motor evoked potential monitoring as they have deleterious effects on the~     amplitude of motor evoked potentials.(Sekimoto, Nishikawa et al. 2006) Hence, total~     intravenous anaesthesia with no intraoperative muscle relaxants, are the standard anaesthetic~     technique for these surgeries.~      Muscle relaxants are usually required during the induction of anaesthesia and endotracheal~     intubation of larynx. Current practice is to wait for the resolution of residual~     neuromuscular blockade before the motor evoked potential recordings (MEPs) are initiated and~     this makes it difficult to assess if there was any neurological injury associated with~     positioning of the patient. A previous case series has shown that reversal of muscle relaxant~     can improve the amplitude of MEPs.(Batistaki, Papadopoulos et al. 2012) The aim of this study~     is to perform a randomised controlled trial to study the changes in motor evoked potential~     amplitudes comparing sugammadex and placebo.~   "
36602|NCT03087500|"~     The overall goal of this study is to evaluate biomarkers of oxidative stress, mitochondrial~     function, and DNA methylation (epigenetics) in order to determine the extent to which these~     biomarkers are related to cognitive, behavioral and adaptive function in Down Syndrome. The~     inter-relationship between measurable biomarkers and functional/cognitive abilities will move~     beyond genetics to provide unprecedented new knowledge and a broader understanding of the~     underlying pathophysiology and abnormal gene expression induced by trisomy 21.~   "
36603|NCT03087487|"~     The primary objectives of this study are to compare the risk of major bleeding and~     stroke/systemic embolism (SE) events among oral anticoagulant (OAC)-naïve non-valvular atrial~     fibrillation (NVAF) patients initiating OAC warfarin or apixaban or dabigatran or rivaroxaban~     treatment.~   "
36604|NCT03087474|"~     In a population of patients with venous thromboembolism and treated with oral anticoagulants~     (OAC) in routine clinical practice in Denmark this study will describe patients treated with~     each OAC~   "
36605|NCT03087461|"~     Breast cancer (BC) and its treatments lead to numerous side effects that affect a person's~     life for years after treatment has ended. Research shows that regular exercise limits many of~     these side effects. However, less than 30% of BC survivors regularly exercise due to many~     barriers that include patients being unaware of the benefits of exercise, health~     professionals facing institutional, personal, and patient-related barriers to promoting~     exercise, and a lack of knowledge translation (KT) strategies within cancer institutions that~     focus on accessible exercise interventions and education by physiotherapists. For this~     project, a pilot study is needed as the first step in order to assess process and resource~     variables before implementation of a large-scale intervention.~      The primary objective of this pilot trial is to assess the feasibility of conducting a larger~     trial to evaluate the effects of a novel KT intervention using exercise and self-management~     versus usual care among BC survivors. The secondary objective is to determine preliminary~     estimates of effects of the KT intervention of exercise plus self-management (SM) program~     versus usual care on (a) levels of exercise knowledge and behaviour, (b) health related~     quality of life and (c) resource utilization, among BC survivors over a four month period.~   "
36606|NCT03087448|"~     This is a phase I/II study of ceritinib and trametinib in Stage IIIB or IV anaplastic~     lymphoma kinase (ALK) rearranged non-small cell lung cancer (NSCLC). The Phase I portion will~     investigate the safety and tolerability of the combination of ceritinib and trametinib in ALK~     or ROS-1 rearranged NSCLC. The Phase II portion will investigate the clinical efficiency of~     the combination of ceritinib and trametinib in 3 single arm cohorts: ALKi (ALK inhibitor)~     naïve patients; post-crizotinib progressed disease (PD) patients; and PD second line ALK~     tyrosine kinase inhibitor (TKI) patients.~   "
36607|NCT03087435|"~     It is necessary and important to design tools to evaluate a central aspect of medical~     residents formation. The research group has been working with resident well-being since a few~     years in order to improve the global quality of the education and working environment. The~     investigators present a plan to develop and validate a tool to assess residents well-being. A~     tool designed with this characteristics would be of much importance to monitored as a~     security event, managed and actively promoted well being in residents.~   "
36608|NCT03087422|"~     This study evaluates the text message (SMS) with orientation to help the management of~     chemotherapy treatment.~   "
36609|NCT03087409|"~     Collection of follow-up data from the original trial patient cohort.~   "
36610|NCT03087396|"~     Post Market clinical outcomes study to collect data on the short - and long-term outcomes for~     subjects who are undergoing or who have undergone the Subchondroplasty Procedure in the foot~     and/or ankle in a standard clinical setting. Outcomes to be assessed include pain medication~     usage, pain, function, activity levels and patient satisfaction.~   "
36611|NCT03087383|"~     In neurosurgical anesthesia, propofol based total intravenous anesthesia (TIVA) is frequently~     used due to brain relaxation and less effect on electrophysiologic monitoring. Response to~     propofol can vary between individuals and be associated with clinical factors including age~     and weight, and genetic polymorphism. Because the importance of rapid recovery in~     neurosurgery with long operation time is emphasized recently, the choice and dose adjustment~     of anesthetics should be determined according to clinical and genetic factors. Recently,~     researches about genetic variations have been performed with single nucleotide polymorphism~     (SNP). The aim of this study is to find SNPs associated with propofol recovery and response~     through genome-wide association study (GWAS) in Korean adult population undergoing propofol~     based TIVA for clipping of unruptured cerebral aneurysm.~   "
36612|NCT03087370|"~     This natural history study is a prospective and retrospective, observational study of WHIM~     patients. WHIM syndrome is a rare, genetic, primary immunodeficiency disorder (a disorder in~     which the body's immune system does not function properly). WHIM is an acronym for some of~     the symptoms of the disorder - Warts, Hypogammaglobulinemia (low levels of certain~     antibodies), Infections and Myelokathexis (too many white blood cells in the bone~     marrow).This study includes 10-year retrospective (Retrospective Phase) and up to 5-year~     prospective (Prospective Phase) components.~   "
36613|NCT03087357|"~     This study will document the detection rate and false positive rate as well as failure rate~     of a new prenatal screening approach ('Smart NIPT') as described at www.vanadisdx.com and~     implemented in an academic laboratory with limited molecular testing experience. Testing will~     be performed on samples from a general risk pregnancy population, with additional high-risk~     cases added to improve confidence in the detection rate. Additional characteristics of this~     non-NGS test such as turn-around time, costs (equipment, training, per test), results~     reporting, fetal sex, fetal fraction, and quality measures will also be examined.~   "
36614|NCT03087344|"~     This is a study that will evaluate the utility of measuring liver and spleen stiffness before~     and after a meal by a non invasive ultrasound based technologies called Fibroscan (Transient~     elastography) and acoustic radio-frequency impulse (ARFI) in diagnosing or excluding~     cirrhosis in patients with chronic liver disease who will be getting a liver biopsy.~   "
36615|NCT03087331|"~     This is a prospective, pre post, pilot cohort study to be conducted in patients with chronic~     pain, which is defined as pain that lasts beyond 3 months. To accomplish the primary and~     secondary objectives of the study, three phrases will be designed and completed during three~     months~   "
36616|NCT03087318|"~     Obesity, associated with obstructive sleep apnea (OSA) is often involved in cardiovascular~     diseases. In our study, we want to promote sport practice to reduce that burden in the first~     place, and all associated diseases (e.g. cardiovascular diseases) consequently. The aim of~     this clinical trial is to determine which type of program, conducted in a digital environment~     associating a mobile application and individual coaching, better improves exercise habits~     over a 3-month period in overweight or moderate obese OSA patients.~   "
36617|NCT03087305|"~     Evaluation of the anatomic extent of a primary lung cancer and presence of metastasis are~     essential for selection of an appropriate management strategy. Endobronchial ultrasound~     transbronchial needle aspiration (EBUS-TBNA) is a reliable and established technique to~     evaluate involvement of mediastinal lymph nodes (LN); however, it is an invasive procedure~     and may not be tolerated in patients with severe underlying lung disease. One exception is~     the superficially located supraclavicular lymph nodes (SCLN), which can easily be biopsied~     with percutaneous US-guided-fine needle aspiration (US-FNA). Traditionally, this nodal group~     is evaluated by palpation; however, literature suggests that palpation itself fails to~     capture 66% of proven disease by cytology, which challenges the acceptance that non-palpable~     nodes are indicative of absent disease. Since all palpable SCLN are biopsied to rule out~     metastasis, we may potentially up-stage more patients using ultrasound evaluation for~     non-palpable nodes; and offer more appropriate management. Currently, the incidence for~     non-palpable SCLN metastasis has not been defined in this patient population presenting for~     EBUS-TBNA. The primary objective is to determine the incidence of supraclavicular lymph node~     metastasis by ultrasound evaluation in patients referred for EBUS-TBNA.~   "
36618|NCT03087292|"~     In our clinical controlled trial, patients with coronary heart disease will be randomly~     assigned into the exercise intervention (low intensity resistance training with vascular~     occlusion) or usual physical activity group (control group).~   "
36619|NCT03087279|"~     Background: Active learning is designed to pair physical activity with the teaching of~     academic content. This has been shown to be a successful strategy to increase physical~     activity and improve academic performance. The existing designs have confounded academic~     lessons with physical activity. As a result, it is impossible to determine if the subsequent~     improvement in academic performance is due to: (1) physical activity, (2) the academic~     content of the active learning, or (3) the combination of academic material taught through~     physical activity.~      Methods / Design: The Texas I-CAN project is a 3-arm, cluster randomized control trial in~     which 28 elementary schools were assigned to either control, math intervention, or spelling~     intervention. As a result, each intervention condition serves as an unrelated content control~     for the other arm of the trial, allowing the impact of physical activity to be separated from~     the content. That is, schools that perform only active math lessons provide a content control~     for the spelling schools on spelling outcomes. This also calculated direct observations of~     attention and behavior control following periods of active learning.~      Discussion: This design is unique in its ability to separate the impact of physical activity,~     in general, from the combination of physical activity and specific academic content. This, in~     combination with the ability to examine both proximal and distal outcomes along with measures~     of time on task will do much to guide the design of future, school-based interventions.~   "
36620|NCT03087266|"~     Thirty-eight periodontitis- and diabetes-affected subjects will be randomly allocated to non~     surgical periodontal treatment with either Full-Mouth Approach (FM-SRP) or Quadrant approach~     (Q-SRP).~      Patients will be seen one day and three months (study completion) after treatment. The 24~     hours appointment will be occurring after the entire completion of the FM-SRP or the first~     quadrant of the Q-SRP. In the latter group other sessions of treatment will be performed~     within the following 3 weeks.~      At baseline, 24 hours and three months, anthropometric, inflammatory and endothelial~     parameters will be collected. Periodontal parameters will be checked at baseline and at three~     months.~      Main outcome of the study is the level of C-reactive protein 24 hours after treatment.~   "
36641|NCT03086993|"~     This study will evaluate two groups of patients who have intrahepatic cholangiocarcinoma.~     Each group will receive induction treatment with Cisplatin and Gemcitabine per SOC for 4~     treatment cycles. Following induction treatment patients will be randomize (1:1), to 2 arms~     of treatment. One group (50%) will be receive high dose chemotherapy delivered specifically~     to the liver, while the other group (50%) will continue treatment with Cisplatin and~     Gemcitabine. Patient in each group will get repeating cycles of treatment until the cancer~     advances. All patients will be followed until death. This study will compare the overall~     survival (OS) in patients with intrahepatic cholangiocarcinoma.~   "
36658|NCT03086772|"~     The main purpose of this randomized controlled trial was to assess the feasibility and~     acceptability of a 12-week Tai Chi program for community-dwelling older adults with chronic~     multisite pain and a history of falling. In addition, the investigators examined the effects~     of Tai Chi on pain characteristics, cognition, physical function, gait mobility, levels of~     pain-related biomarkers, fear of falling and rate of falls in these older adults.~   "
36621|NCT03087253|"~     Genetic lipodystrophy syndromes are extremely rare, orphan diseases with overall estimated~     prevalence of less than 2,000 in the United States. These rare disorders characterized by~     selective loss of adipose tissue and predisposition to insulin resistance and its metabolic~     complications diabetes, dyslipidemia and hepatic steatosis. Due to these metabolic problems,~     atherosclerotic vascular disease, recurrent episodes of acute pancreatitis, cirrhosis and~     other morbidities complicate the lives of these patients.~      In the last few years, several genes for CGL (AGPAT2, BSCL2, CAV1 and PTRF); FPL (LMNA,~     PPARG, AKT2, CIDEC, LIPE, PLIN1, PCYT1A and ADRA2A); MAD (LMNA and ZMPSTE24); APS (LMNA);~     autoinflammatory (PSMB8); NPS (FBN1, CAV1); SHORT syndrome (PIK3R1); and MDP syndrome (POLD1)~     have been identified. However, there is paucity of information about the natural history of~     these rare syndromes, especially genotype-specific causes of morbidity and mortality.~      To overcome the problems outlined above, this multicenter, collaborative, prospective,~     observational natural history cohort study will be conducted on approximately 500 patients~     with genetic lipodystrophy syndromes. Patients will be assessed on a yearly basis for~     approximately 4 years to collect robust clinical, metabolic, morbidity and mortality data.~     Medical history and patient questionnaires will be completed on a yearly basis by patients~     registered in the study. Clinical data such as vitals, laboratory results and anthropometric~     measurements will also be collected from patients' medical records if available.~   "
36622|NCT03087240|"~     This study evaluates the influence of dental prophylaxis on disease activity of Rheumatoid~     Arthritis. In addition to standard antirheumatic therapy, recently the question has been~     raised whether or not there is a supplementary beneficial effect due to professional teeth~     cleaning. So far just a few studies pursued this question, indicating that prophylaxis by~     dental professionals can alleviate the symptoms of Rheumatoid Arthritis. To further evaluate~     this question, in our study half of the participants will receive dental prophylaxis at their~     first visit, after 2 weeks and 3 months, while the other half will receive professional teeth~     cleaning after 3 months only.~   "
36623|NCT03087227|"~     The use of e-health in improving the quality of health services is a rapidly expanding~     research area, in particular its usefulness in patient management of the home-hospital care~     pathway. Febrile neutropenia is a serious and frequent complication of cytotoxic chemotherapy~     and better identification of low-risk patients who can be treated at home could be made~     possible by these technologies.~      The objective of this study is to evaluate a shared health information system (NEUTROSIS) for~     home-hospital management of febrile neutropenia after anti-tumor chemotherapy. The study aims~     to compare the average length of hospital stay for febrile neutropenia among patients~     receiving NEUTROSIS and those receiving standard care~      Materials and methods A shared information system (NEUTROSIS) has been developed to connect a~     smartphone web application for the patient to the existing shared medical record of the Paris~     Sud hospital group (AP-HP, France - 4D software).~      The study consists of conducting a randomized controlled trial to compare a cohort of~     patients receiving cytotoxic chemotherapy for solid cancer or heamatological malignancies~     using the NEUTROSIS shared information system (n=100) and a cohort of patients followed by~     the hospital's standard care over a treatment period of six months (n=100). During the 15~     days following each chemotherapy cycle, the 2 groups of patients must take their temperature~     daily. Both groups are trained like any patient under chemotherapy to contact the team in~     case of fever. The NEUTROSIS group captures daily its temperature and the occurrence of other~     symptoms on the smartphone application. This information is then transmitted instantly to the~     hospital care team who will be alerted in case of fever and will contact the patient. The~     control group will indicate these same data in a paper diary and will have to contact the~     health team in case of fever as done in the usual care.~      The two groups of patients will be followed 6 months through a questionnaire asked to the~     patient at each hospital visit for chemotherapy cycle. The questionnaire collects information~     on the occurrence of symptoms and healthcare use between two chemotherapy cycles. A last~     follow-up questionnaire is asked by phone at the endpoint follow-up (6 months). The study~     will take place in two hospital sites of the Paris University hospital (A Béclère and~     Kremlin-Bicètre).~   "
36624|NCT03087214|"~     The epidemiology and ecology of malaria in humans includes complex interactions between human~     hosts and mosquito vectors. These interactions are spatio-temporal in nature and are heavily~     dependent on transportation capabilities and seasonal conditions. Where and when infections~     are acquired is not well understood in the Greater Mekong Subregion (GMS), where there are~     numerous vectors, many with different behaviours and habitats. For example, many infections~     appear to be associated with forests or forest edges and some of the most important mosquito~     vectors in the region are forest dwellers (Obsomer, Defourny, and Coosemans 2007).~     Interventions that target houses at night-time (e.g. mosquito nets), have had limited success~     in the GMS, most likely because at least some infections are acquired during the day or~     outside of the home (Dolan et al. 1993; Luxemburger et al. 1994).~      While overall malaria incidence in the region appears to be declining, the disease remains~     persistent in small subregions, for example along international borders joining Thailand with~     Myanmar. It will be crucial for elimination efforts to address the persistent malaria in~     these regions, most likely requiring the use of novel and spatially targeted approaches.~      Increasingly, spatial data and analyses are used in disease research (Linard and Tatem 2012;~     Pybus et al. 2016; Tatem et al. 2012), however most spatial analyses are at aggregate scales,~     using data from provincial or state levels. More detailed studies have a single geographic~     reference point per individual in the study, frequently the home (Mosha et al. 2014; Parker~     et al. 2015). These studies allow researchers to investigate potential clustering of cases~     within and between houses (hotspots) (Bejon et al. 2014; Bousema et al. 2012; Mosha et al.~     2014). Even these detailed studies typically ignore the spaces in which people spend time~     outside of their home and where they may acquire infection: schools; places of worship and~     work; forest camps and temporary shelters. Given that many malaria infections in the GMS are~     acquired outside of the home, in areas that are not usually mapped, this information is~     important for developing strategies to prevent transmission and will be crucial for achieving~     elimination.~      Researchers in other substantive areas have already begun mapping the movement patterns of~     study subjects so that exposure to a variety of environmental exposures outside of the home~     can be assessed (Matthews and Yang 2013; Vazquez-Prokopec et al. 2010). Early approaches~     relied on travel surveys or travel diaries, both having bias of unknown magnitude. Modern~     wearable global positioning satellite (GPS) instruments (loggers or trackers) and geographic~     information science (GIS) enable detailed mapping and quantification of human movement~     patterns. Through analysing differences in the movement patterns between humans who do versus~     those that do not acquire infectious diseases, it may be possible to identify a narrower set~     of geographic spaces in which disease transmission is occurring. Public health interventions~     could then target those risk areas.~      Most of these detailed studies have been done in economically developed settings and urban~     environments. Infectious diseases such as malaria remain persistent in resource-poor, rural,~     and remote areas - the very regions that are least likely to be studied with detailed~     approaches (Sachs and Malaney 2002).~   "
36625|NCT03087201|"~     This is a multicentre, randomized, double-blind, placebo controlled, parallel-group, phase~     IIIb trial.~      Patients (≥18 years) with chronic tic disorders and Tourette syndrome will be recruited.~      The objective of the trial is to demonstrate that treatment with the cannabis extract~     nabiximols is superior to placebo in reducing tics and comorbidities in patients with~     Tourette syndrome and chronic tic disorders.~   "
36626|NCT03087188|"~     There are different therapy strategies for patients suffering on obstructive lung disease~     like chronic obstructive pulmonary disease (COPD), and asthma bronchial available. One of~     these strategies includes inhalative drugs, e.g. ß2-mimetics, anticholinergic drugs, or~     glucocorticoids, which are indicated often and which can be used with different inhalation~     devices. Dry powder inhalators, and dosieraerosol are used the most in clinical routine.~     Further strategies in treating obstructive lung disease are innovative systems like Respimat~     or systems with liquid inhalation. However, the success of the therapy depends on the correct~     application technique. In the clinical routine a high error rate was observed. Consequently,~     the initiative of the German league of respiratory tracts published internet-based film~     sequences in order to demonstrate how to use an inhalator correctly. These films are~     available in the internet for everyone and can be watched as often as needed in order to~     improve technique and facilitate training.~      Therefore, in this study we aim to evaluate the following aspects:~        -  amount of wrong applications in ambulant and hospitalized patients (wrong in terms of~          lack of knowledge on how to use the inhalator or incorrect utilization)~        -  amount of correct applications in patients who had first used the inhalator incorrectly~          but improved technique by watching the film sequences~        -  evaluation of learning success within 2 weeks to 2 months (follow-up visit in the~          ambulance)~   "
36627|NCT03087175|"~     NSTE-ACS represents the most frequent indication for coronary angiography and percutaneous~     coronary intervention (PCI) worldwide. PCI permit to reestablished coronary flow but~     effectiveness of PCI within thrombus containing lesions is limited by the risk of occurrence~     of distal embolization and no-reflow phenomenon. Distal embolization lead to coronary~     microcirculation lesions. This complication is related to poor prognosis.~      MGuard stent is a stainless-steel closed cell stent covered with an ultra-thin polymer mesh~     sleeve, which allows to prevent distal embolization during percutaneous coronary intervention~     in ST-segment-elevation myocardial infarction.~      Index of microcirculatory resistance (IMR) is a validated method to assess coronary~     microcirculation.~      Accordingly, the purpose of this study is to demonstrate that MGuard micronet mesh-covered~     stent prevent distal embolization and microvascular reperfusion impairment during primary~     PCI, compared with a bare metal stent (BMS) and drug eluting stent (DES) in patients with~     NSTE-ACS, assessed by Index of microcirculatory resistance.~   "
36628|NCT03087162|"~     New drug regimen for Helicobacter pylori eradication, the investigators compare once daily~     dose dexlansoprazole levofloxacin based quadruple therapy and twice daily dose~     dexlansoprazole levofloxacin quadruple therapy for helicobacter pylori eradication.~   "
36630|NCT03087136|"~     Pediatric Multiple sclerosis (MS) is a chronic inflammatory disease defined by multiple~     episodes of demyelination of the central nervous system (CNS) separated by time and space as~     specified in adults not explained by acute disseminated encephalomyelitis (ADEM). Several~     studies have indicated that at least 5% of MS patients are in the pediatric population, but~     no prospective study was performed in Brazil. There are particular characteristics of~     Pediatric MS that differs from the adult population and have been focus of interest in the~     last years. However, we still lack high evidence data, specially concerning treatment, of~     this age group.~      This is an observational non-interventional multicenter study in pediatric MS patients in~     which participating subjects will be characterized by their clinical, MRI and immunological~     features. In this observational study, we will select 8 MS centers in Brazil to recruit at~     least 100 pediatric patients currently followed on each center with idiopathic inflammatory~     CNS disorders over a 2-year study period. We will collect retrospective and prospective~     clinical and MRI data to determine the proportion of patients who fulfill the International~     Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for MS,7 especially on those below~     10 years where the use of McDonald 2010 criteria is not recommended routinely. Following the~     inclusion on the study, subjects will be followed for at least 2 years.~      All subjects enrolled in this study will have serum collected to test autoantibodies~     including anti-AQP4 and anti-MOG using cell-based assays with transfected cells.8 Pediatric~     patients with positive testing for these autoantibodies will be analyzed separately.~      Exploratory MRI sub-study In 10 patients recruited at Hospital São Lucas PUCRS, we will~     perform an exploratory substudy with advanced MRI using q-space diffusion protocol on a~     3-Tesla MRI (GE Signa HDx 3.0T, General Electric, Milwaukee, WI, USA) and a 8-channel head~     coil to visualize remyelinating brain MS lesions. Normalized leptokurtic diffusion (NLD) data~     will be acquired using diffusion-weighted echo planar imaging. All MRI scans from this~     exploratory study will be performed at the Brain Institute of Rio Grande do Sul (BraIns).~     Only patients with previous brain demyelinating lesions will be included in this exploratory~     sub-study.~   "
36631|NCT03087123|"~     Community based interventions are more acceptable to community members when all participants~     receive the intervention. A 'stepped-wedge' or 'multiple-baseline' design allows for all~     participants to receive the intervention by randomizing participants into conditions defined~     by the length of the baseline period. The primary aim of this pilot study is to gather data~     that will allow the researchers to estimate parameters, such as the appropriate length of the~     baseline period that will allow them to power a larger study. A second key aim is to~     determine if a smartphone intervention that is delivered to parents can increase physical~     activity in their 6-10 year old inactive children.~   "
36632|NCT03087110|"~     This study will investigate the safety of single dose intravenous infusion of cord blood~     cells which were cryopreserved after the birth of a brother or sister to a child with~     cerebral palsy.~   "
36633|NCT03087097|"~     This single-center, randomized, double-blinded trial will compare the safety and efficacy of~     FMT given enema in subjects 18-60 months of age with uncomplicated, non-edematous SAM not~     responsive to standard therapy. Subjects must meet inclusion criteria, no exclusion criteria~     prior to randomization. Subjects will then be randomized by stratified random sampling (by~     age, diarrhea, MUAC and hyponatremia) in a 1:1 ratio at each site to 1 of 2 treatment groups:~        -  FMT by enema: 10mL/kg (maximum 60mL) of donor fecal material will be infused.~        -  Placebo by enema: 10mL/kg (maximum 60mL) of placebo material will be infused.~      Subjects will be evaluated through 56 days (±5) after randomization for primary outcomes~     (safety) as well as secondary outcomes (nutritional, clinical and microbiological response).~     See definition under endpoints/outcome measures above).~      Stool samples will be collected at enrollment and through days 3, 7, 14, 21, 42 and 56.~     Samples will be used for microbiome determination and other exploratory microbiological~     endpoints. An aliquot of donor stool will also be stored for microbiome determination and~     other exploratory microbiological endpoints and assessment of newly acquired infectious~     agents.~   "
36634|NCT03087084|"~     The purpose of this prospective, non-randomized, single-arm, research study is to evaluate~     the accuracy of acutely extracting respiratory rate and tidal volume from implanted cardiac~     device impedance in subjects with heart failure.~      In addition, to assess the feasibility of extracting respiratory rate from device EGM under~     various conditions.~   "
36635|NCT03087071|"~     The goal of this clinical research study is to learn if panitumumab alone or in combination~     with trametinib can help to control advanced colorectal cancer. The safety of these drugs~     will also be studied.~   "
36636|NCT03087058|"~     The purpose of this study is to evaluate the change in serum (blood) potassium levels from~     start of treatment to Day 14, when patiromer is administered at different doses, once daily,~     in children 2 - < 18 years of age with chronic kidney disease (CKD) and hyperkalemia (too~     much potassium in the blood). Another purpose of the study is to evaluate the safety and~     tolerability of patiromer in children 2 - < 18 years of age with CKD and hyperkalemia.~   "
36637|NCT03087045|"~     The purpose of this investigation is to investigate the behavioral manifestations of~     listening effort. Quantifying listening effort based on an easy to measure behavioral metric~     would allow for better understanding of the effort that goes into processing conversational~     speech. The investigators hypothesize that the behavior modifications required to improve the~     signal to noise ratio in increasingly complex listening environments significantly deviates~     from quiet listening environments. Further, the investigators hypothesize that this directly~     contributes to increased listening effort and reduced ability to accurately monitor content~     for everyday conversation.~   "
36638|NCT03087032|"~     The present 24-week, prospective, open-label, randomized, multicenter, parallel group trial~     is carried to investigate and evaluate the effectiveness and safety of adding Liraglutide vs~     insulin Glargine to prandial insulin in type 2 diabetes patients treated with premixed~     Insulin.~   "
36639|NCT03087019|"~     This research study is studying immunotherapy with or without radiation therapy as a possible~     treatment for adenoid cystic carcinoma.~      The immunotherapy involved in this study is:~        -  Pembrolizumab (MK-3475 or KEYTRUDA).~   "
36640|NCT03087006|"~     Patients with dry eye disease (DED) will be randomized to Automatic Self Transcending~     Meditation (ASTM) plus Treatment as Usual (TAU) or TAU alone to assess changes in~     Health-related quality of life (HRQoL). HRQoL is a vital construct focusing on impact of~     health on quality of life. HRQoL data is used in economic evaluations, a component of health~     economics that compares the cost and consequences of alternative courses of action. This~     helps policy-makers make complex financial decisions. Along with HRQoL we will measure~     changes in extent of depression as well as anxiety. Previously published data lacks~     information of HRQoL in patients with DED. Through this study we shall attempt to correlate~     HRQoL in this population and assess if ASTM confers changes in HRQoL along with depressive~     and anxiety symptoms.~   "
36689|NCT03086369|"~     The purpose of this study is to determine the safety and efficacy of nab-paclitaxel and~     gemcitabine with or without olaratumab in the treatment of first-line metastatic pancreatic~     cancer.~   "
36642|NCT03086980|"~     Patients with glaucoma will be randomized to Automatic Self Transcending Meditation (ASTM)~     plus Treatment as Usual (TAU) or TAU alone to assess changes in Health-related quality of~     life (HRQoL). HRQoL is a vital construct focusing on impact of health on quality of life.~     HRQoL data is used in economic evaluations, a component of health economics that compares the~     cost and consequences of alternative courses of action. This helps policy-makers make complex~     financial decisions. Along with HRQoL we will measure changes in extent of depression as well~     as anxiety. Previously published data lacks information of HRQoL in patients with glaucoma.~     Through this study we shall attempt to correlate HRQoL in this population and assess if ASTM~     confers changes in HRQoL along with depressive and anxiety symptoms.~   "
36643|NCT03086967|"~     The Foley catheter is a safe, effective method for cervical ripening. Limited data exists to~     indicate ideal time of placement for optimal cervical ripening prior to induction. The~     proposed study is a randomized control trial to determine if shortening placement from 12 to~     6 hours of foley catheter can decrease time from start of induction to delivery. The~     prediction is that shortening foley bulb placement will result in shorter induction times,~     increased patient satisfaction and decreased length of stay on labor and delivery with~     secondary decreased medical costs.~   "
36644|NCT03086954|"~     This open, single-arm,multicenter 2 phase clinical study will treat the patient who have CD19~     positive lymphoma with an infusion of the patient's own T cells that have been genetically~     modified to express a chimeric antigen receptor(CAR)that will bind to tumour cells modified~     to express the CD19 protein on the cell surface. The study will determine if these modified T~     cells help the body's immune system eliminate tumour cells .The trial will also study the~     safety of treatment for CAR-T, how long CAR-T cells stay in the patient's body and the impact~     on this treatment for survival.~   "
36645|NCT03086941|"~     Aim of the work~      To compare between use of I-gel as a conduit for blind intubation and as a conduit for~     fiberoptic guided intubation in children and also aim to validate the use of I-gel as conduit~     for blind intubation in absence of fiberoptic or lack of experience of its use.~      Objectives:~        -  To validate I-gel use as blind intubating conduit in children.~        -  To Estimate the duration of blind intubation using I-gel and duration of fiberoptic~          guided intubation through I-gel.~      Ethical Considerations~      The study protocol will be approved by the Research Ethics Committee.~   "
36646|NCT03086928|"~     Restoration of anterior teeth using conservative approach allows clinicians to provide~     porcelain laminate veneers with excellent esthetics without extensive tooth structure~     removal. laminate veneers need the use of etch-able ceramics like glass ceramics (E.max) and~     hybrid ceramics (Lava Ultimate). The aim of this study is to compare both e.max and lava~     ultimate veneers clinically.~   "
36647|NCT03086915|"~     In retrospective data search the investigators will identified the percentage of patients~     with muscle relaxants administered during perioperative period. The block reversal, typ of~     drug, percentage of cases with and without reversal will be identified.~   "
36648|NCT03086902|"~     Several reports have shown the utility of PVC ablation with cryo catheters. The aim of this~     study is to compare the outcomes and safety of Cryo vs. RF for PVCs.~   "
36649|NCT03086889|"~     The investigators will conduct a single-blind, randomized controlled trial of 60 patients~     with subacute stroke. Patients will be randomly assigned into a control group and an~     intervention group. The intervention group will participate in immersion VR training for 3~     weeks. The control group will receive for traditional rehabilitation training for 3 weeks.~     Then, the patients will be reevaluated to determine changes in upper extremity function,~     cognitive function, cortical and subcortical activation patterns, and performance of~     activities of daily living after the baseline assessment.~   "
36650|NCT03086876|"~     About 1-2% of the population have a Learning disability (LD). This is a lifelong condition~     characterised by an IQ less than 70, general developmental delay and limitations in day to~     day activities. Children and adults with LD are some of the most under-served groups in~     society, with well documented health disparities and at four times the risk of developing a~     mental disorder. Reports indicate that challenging behaviour, e.g. temper tantrums,~     aggression or self injury, occurs in as many as 40,000 young people under 18 years living in~     England. There is a significant evidence from research in the general population that~     parenting groups which support parents in developing skills to manage such behaviours in~     their child can be helpful. These programmes, if offered to parents early on, may reduce and~     even prevent serious emotional problems and possible criminality from developing in the child~     later in life. Cost benefits are associated with improved health and social outcomes in the~     young person. The National Institute of Health and Care Excellence (NICE) guideline on~     behaviour that challenges reviewed all the available evidence and found very few thoroughly~     researched programmes specifically developed for children and young people with LD and~     challenging behaviour. NICE, therefore, recommended that further research should be~     undertaken to address the lack of evidence based interventions to reduce challenging~     behaviour in the population of young people with LD.~      In this study, we propose to evaluate a programme called level 4 Stepping Stones Triple P~     (SSTP) delivered by trained practitioners to groups of parents of young children aged 30-59~     months with moderate to severe LD . The programme lasts for 9 weeks and has shown positive~     results in small trials outside the UK, indicating that it is a potentially helpful. However,~     it needs to be tested within the UK health system before recommendations can be made to roll~     it out. Level 4 SSTP helps parents understand and manage their child's behaviour and parents~     may benefit from peer support in a group setting. We shall recruit 258 parents who will be~     allocated to one of two groups by chance: one will receive SSTP and treatment as usual and~     the other treatment as usual, a list of resources and the Contact a Family guide to~     challenging behaviour. Treatment as usual includes support and advice by GPs or child~     development teams. We shall use parental reports and observations of child behaviour to~     examine whether SSTP reduces challenging behaviour at four (short term) and 12 (long term)~     months after randomisation. We shall also ask other carergivers' about the child's behaviour,~     the child's and the parent's health related quality of life, difficulties with care, parent~     stress, service use and how the parent has found the intervention using both questionnaires~     and face to face interviews.~      We shall interview the service managers and the therapists about their experience of hosting~     and delivering the intervention. We shall recruit parents to the Parent Advisory Group to~     advise about various aspects of the study, e.g. materials, interview topic guides,~     dissemination. We are a group of researchers and clinicians with expertise in LD, child~     health and early intervention who have conducted several large trials with this population.~      Our trial will last 48 months and will follow all statutory research governance requirements~     to ensure that it is high quality, safe and ethical.~   "
36651|NCT03086863|"~     This is a multicenter, randomized, sham-controlled, patient- and assessor-blinded, and~     parallel trial to explore the effectiveness and safety of electroacupuncture (EA) therapy,~     compared with sham EA, for poststroke shoulder pain.~   "
36652|NCT03086850|"~     Main objective: To assess the effect of the daily physical activity promotion with a~     pedometer during 12 months on the apnea-hypopnea index (AHI) in patients with mild to~     moderate obstructive sleep apnea (OSA).~      Study patients. Subjects 30-80 years old with diagnosis of mild-moderate OSA (AHI: 5-30 and~     predominance of obstructive events [>80%)].~      Design. Randomized, parallel and open-label clinical trial, controlled with conventional~     treatment.~      Intervention: Patients will be randomized (1:1) to control group [treatment and follow-up~     according to conventional clinical practice] or intervention group [in addition to~     conventional treatment and follow-up, the patients will receive a pedometer to measure the~     number of steps walked daily. Based on the cumulative step count for each day and the mean~     value since the last visit, patients will receive a task to increase their steps per day by~     the next appointment according to the next protocol (<6000 steps/day: increase by 3000~     steps/day; 6000 - 10000 steps/day: reach 10000 steps/day; and > 10000 steps/day: maintain or~     increase steps).~      Measurements. At , 12, 24 and 52 weeks of randomization, the following determinations will be~     made: anthropometric characteristics; clinical evaluation (smoking history, sleep symptoms,~     comorbidities, current medication); questionnaires (ESS, FOSQ, SF-12, EuroQoL and iPAZ);~     heart rate and blood pressure; analytical determinations (HbA1c, HOMA index, cholesterol,~     LDL-cholesterol, HDL-cholesterol, triglycerides, homocysteine, NT-proBNP and hsCRP);~     plasmatic biomarkers (8-isoprostane, IL1beta, IL6, IL8 and TNFalpha); and evaluation of daily~     physical activity using an accelerometer.~   "
36653|NCT03086837|"~     Physical inactivity is still a major public health problem. Active transportation i.e.~     walking or cycling for transport can contribute to greater total physical activity. The~     specific aim of this study is to evaluate if a 12-week mobile phone application can increase~     time spent in active transportation (cycling or walking) and in moderate-to-vigorous physical~     activity in Swedish adults aged 20-65 years.~   "
36654|NCT03086824|"~     The purpose of this study is to investigate the safety and effectiveness of subjects~     receiving MR-guided Focused Ultrasound (MRgFUS) treatment for painful bone metastases. This~     study will evaluate treatment response and clinically significant adverse events. Other~     relevant data may be documented as well.~   "
40310|NCT03039101|"~     The purpose of this study is to see if the recruitment of a certain cell type (the alpha 4~     integrin (CD49d) expressing neutrophil) during a nasal allergen challenge can be inhibited by~     pretreatment with an FDA approved leukotriene antagonist (montelukast).~   "
36659|NCT03086759|"~     Osteoarthritis of the knee is a very prevalent disease. However, there are few therapeutic~     options for its patients. Platelet-rich plasma is a treatment option for chronic pain. If~     proven to be effective in its intra-articular use, Platelet-rich plasma may help in the~     treatment of these patients.~      Goal:~      Primary objective: To compare effectiveness in improving pain and function and the~     medium-term tolerance (12 weeks) of intra-articular injection of Platelet-rich plasma versus~     intraarticular injection of triamcinolone hexacetonide in patients with symptomatic primary~     knee osteoarthritis.~      Secondary objective: To compare the medium-term effectiveness of intra-articular injection of~     Platelet-rich plasma versus intra-articular injection of triamcinolone hexacetonide to~     improve synovial hypertrophy and quality of life in these patients.~      Methods: A prospective randomized controlled double-blind study with three groups (each with~     n = 33) of patients with symptomatic osteoarthritis of knees who will receive intra-articular~     infiltration in a single moment. Patients will be allocated to one of three groups: 1)~     Platelet-rich plasma group: patients who will receive plasma; 2) triamcinolone hexacetonide~     Group: patients who will receive 40mg of triamcinolone hexacetonide; And 3) Isotonic saline~     solution group: patients who will receive isotonic saline solution. The patients will be~     evaluated by blind evaluators in 4 assessment times up to 12 weeks of follow-up through~     clinical assessment instruments (rest and movement pain, joint edema, goniometry, clinical~     improvement scale, quality of life questionnaire as the SF36), functional (Womac~     questionnaire, M. Lequesne Functional Knee Index, 6 min walk test, Time up and go test), and~     ultrasound test (quantitative and semiquantitative measurement of synovial hypertrophy and~     semiquantitative Power Doppler).~      Statistics: The following statistical tests will be used according to the need: Student's t~     test, Mann-whitney, Pearson's chi-square test and ANOVA for repeated measures. A statistical~     significance of 5% will be considered.~   "
36660|NCT03086746|"~     To provide insight into why vitamin D levels at baseline predict an adverse outcome including~     hospitalisation, we will establish whether baseline vitamin D levels are an independent~     marker of LV remodelling in patients experiencing an ST segment elevation myocardial~     infarction.~   "
36661|NCT03086733|"~     This is a phase II single centre open label single arm pre-operative window of metformin~     treatment in stage I-IIIa Non small cell lung cancer.~      In which patients will be invited to participate by receiving Metformin treatment during 14~     to 21 days at 850 mg BID until the day before surgery.~      They will be followed closely for any Adverse Events during treatment and 30 days after~     surgery. During treatment there will be no follow up tests except 1 fasting blood glucose at~     week 2 of treatment.~      Survival data will be prospectively gathered after study treatment has ended until death.~   "
36662|NCT03086720|"~     This study will verify the effect of the application of a substance (10% sodium hypoclorite~     -NaOCL) in dentin on noncarious cervical lesions, with the aim of increasing the longevity of~     the restorations performed in this type of lesion.~      The hypothesis of the present study is that the application of deproteinization solution~     after acid etching does not influence the failure rate of the restorations.~   "
36663|NCT03086707|"~     This study intends to evaluate the nasal mucociliary clearance (NMC) by determining the value~     obtained for saccharin transit time (STT) test over the course of 12 hours following a single~     cigarette use in smokers, to compare it relative to never smokers, and to examine the~     relationship between plasma nicotine levels and STT value in smokers and never smokers.~     Safety will also be monitored during the study.~      The planned maximum study duration for a single study participant from Screening through~     completion of study will be 33 days.~   "
36664|NCT03086694|"~     Orthognathic surgery, one kind of Oro-maxillofacial surgery, is a complicate surgery that~     undergoes several hours with nasotracheal intubation general anesthesia. To limit blood loss~     during operation, the patients are often under intentional hypotension. However, the~     intentional hypotension may confuse with hypovolemic induced low blood pressure. The~     hypothesis is using flotrac (to measure stroke volume variation) to keep the patients~     hemodynamics stable under Tridil and propofol infusion and avoid over-infusion of crystalloid~     or colloid and prevent hypovolemia induced postoperative nausea and vomiting.~   "
36665|NCT03086681|"~     A total of 120 patients with pathologically confirmed Locally advanced cervical carcinoma~     were enrolled. Patients were randomly divided into two groups, with 60 patients in each~     group. One group was treated with Concurrent Chemoradiotherapy combined with Endostar and the~     other group was treated with Concurrent Chemoradiotherapy. The short term efficacy and the~     toxic of these treatments were evaluated. The 1-year, 3-year, 5-year overall survival and~     progression-free survival of patients were analyzed. The investigators data may provide an~     alternative option for the treatment of Locally advanced cervical carcinoma with high~     efficacy and low toxicity.~   "
36666|NCT03086668|"~     to compare either using conventional jaw thrust technique or with a novel fingers-hook~     technique to facilitate video-stylet assisted nasotracheal intubation~   "
36667|NCT03086655|"~     Currently available methods to monitor antiretroviral (ARV) adherence to HIV treatment and~     prevention, such as self-report, pill counts, medication electronic monitoring system (MEMS),~     and devices which wirelessly monitor adherence in real-time, have multiple limitations,~     including over-reporting, inability to assess pill ingestion, and size/expense. Our~     multidisciplinary research team at the University of California, San Francisco (UCSF) and in~     India has designed a new adherence-monitoring device called Tel-Me-Box which is small,~     low-cost, rechargeable, inconspicuous, and could be programmed to deliver tailored real-time~     adherence reminders following additional hardware modifications. The aim of this study is to~     modify and validate this discreet Tel-Me-Box (TMB) adherence monitoring and reminder device~     against hair ARV concentrations as a pharmacologic measure of drug ingestion/adherence, a~     measure pioneered and validated by our team, with the expectation that this device and~     intermittent hair monitoring could have widespread utility for HIV and non-HIV adherence~     science, both in India and globally.~   "
36668|NCT03086642|"~     The purpose of this study is to find out which doses of talimogene laherparepvec (T-Vec) can~     be given safely to participants with pancreatic cancer that is either too big to be taken out~     by surgery or has spread to other parts of the body. The study will also see if T-Vec can~     cause tumor shrinkage or prevent its growth.~      The primary objective is to determine the rate of dose limiting toxicity at tested doses of~     talimogene laherparepvec administered endoscopically to pancreatic tumors, and to identify a~     maximum tolerated dose (MTD).~      Secondary exploratory efficacy endpoints include change in longest diameter in the injected~     lesion(s), overall response rate (ORR) per RECIST v1.1 and modified immune-related response~     criteria (mirRC as defined in section 11), progression free survival (PFS) and overall~     survival (OS) at 6, 12, and 24 months.~   "
36690|NCT03086356|"~     The primary objective of the trial is to investigate the pharmacokinetics and~     pharmacodynamics of idarucizumab in Chinese healthy male and female subjects following~     intravenous administration of idarucizumab followed by idarucizumab with 15 minutes interval~     when administered at or close to the steady state of dabigatran.~      Another objective of this trial is to explore the effect idarucizumab on the PK~     (pharmacokinetic(s)) and PD (pharmacodynamic) parameters of dabigatran.~   "
36669|NCT03086629|"~     The Patient Concerns Inventory (PCI) for head and neck cancer (HNC) patients has been~     developed and used largely within the confines of a single clinic setting and has not been~     used routinely with patients in the first year following treatment. Research so far suggests~     it is popular with patients, they would like to continue to use it in clinic and it is~     feasible. Benefits of its routine repeated use is untested, notably its impact on improving~     QOL and in reducing emotional distress, especially within the first year after treatment when~     patients are more likely to benefit from repeated use of the PCI.~      The overarching aim of the proposed research is to explore whether the routine use of the PCI~     in review clinics during the first year following head and neck cancer treatment can improve~     patients quality of life.~      The primary outcome is an improvement in QOL. Secondary outcomes are:~      social-emotional scale, distress thermometer and health economics.~      This will be a pragmatic cluster randomised control trial with consultants randomised to~     either 'using or 'not using' the PCI at clinic. It will involve two centres. 416 patients~     from at least 10 consultant clusters are required to show a clinically meaningful difference~     in the primary outcome.~      Intervention; Patient completion of the PCI and its inclusion into the regular review clinic~     consultation is the 'intervention' and is compared to standard out-patient follow-up. The~     pre-consultation questionnaires and PCI will be used from the first post-treatment clinic~     (i.e. baseline) onwards for one year. Completion of all pre-consultation questionnaires and~     the PCI is by computer (IPAD).~   "
36670|NCT03086616|"~     This is a Phase I and Early Efficacy Study of Convection Enhanced Delivery (CED) of~     irinotecan liposome injection (nal-IRI) Using Real Time Imaging with Gadolinium in Children~     with Diffuse Intrinsic Pontine Glioma who have completed focal radiotherapy~   "
36671|NCT03086603|"~     The study is aimed at observe how spinal anesthesia modifies the hemodynamic state of the~     patient after optimization to preload independence with a Goal Directed Therapy algorithm~     guided by non invasive hemodynamic monitoring with Clearsight.~   "
36672|NCT03086590|"~     To associate a lean mass, peripheral muscle strength, kinematic thoracic-abdominal,~     respiratory metabolic response, mobility and diaphragmatic thickness, verifying its relation~     with the obstruction level of COPD~   "
36673|NCT03086577|"~     Leg ulcers are a significant cause of impaired functional ability and quality of life for~     approximately 1-2 percent of the population in western countries. Although pain seems to be~     one of the most devastating aspects of living with a chronic ulcer, research is limited and~     there is a lack of knowledge about wound-related pain characteristics. Little is known about~     prevalence, pain intensity, qualities, location, temporal fluctuations, to witch degree pain~     impact on physical- and psychosocial functioning, as well as relieving and exacerbating~     factors.~      The overall purpose of this study is to investigate the prevalence and characteristics of~     wound related pain in patients with chronic leg ulcers. More specific research questions are:~     1) What is the prevalence and characteristics of wound related pain in patients suffering~     from various types of persistent ulcers, 2) How do patients with different ulcer diagnoses~     report the quality of the wound related pain, 3) Is there any differences in wound pain~     characteristics among patients with different etiology leg ulcers, 4) How is the pain~     temporal pattern in patients with chronic leg- and foot ulcers, 5) What is the reported~     quality of life in patients with different ulcer diagnosis, and 6) Is there any association~     among pain characteristics, sleep and quality of life in patients with chronic leg/foot~     ulcers? The study has a non-experimental, explorative and descriptive approach. A~     cross-sectional questionnaire design will be used to explore patient's experience of~     wound-related pain.~      The patients will be recruited at the outpatient clinic appointment and home-care nursing in~     Norway. Participants will fill out self-report questionnaires. The battery of questionnaires~     will obtain information about demographic data, pain characteristics, quality of life and~     sleep. Pain characteristics, quality of life and sleep will be assessed by using different~     questionnaires that has demonstrated high validity and reliability. In addition, the temporal~     pattern of pain will be assessed by asking the participants to fill out a form stating~     subjective level of pain (NRS) every hour during a typical day, and to mark times that they~     rest and sleep. Relevant information about the diagnosis/classification of ulcer,~     comorbidities, the ulcer management and pain management will be collected in a clinical~     examination.~   "
36674|NCT03086564|"~     The effect of anti-tumor treatment is not satisfying in HBV-related hepatocellular carcinoma~     (HBV-HCC) for reasons that HBV-HCC carries highly heterogeneous antigens to facilitate cancer~     cells escaping from immune surveillance and constructs an immunosuppressive microenvironment.~     Correspondingly, dendritic cells activated by HBV antigen peptides and HepG2 cell protein~     lysate can efficiently present T cells with antigens of HCC to sensitize their antitumor~     properties meanwhile cyclophosphamide(CY) can effectively improve the microenvironment of~     immunity. Therefore, we put forward a new scientific therapy called Activated~     Dendritic-cells Combined Cyclophosphamide (ADCC) combining with TACE for patients with~     advanced hepatocellular carcinoma to prolong their survival time.~   "
36675|NCT03086551|"~     This study uses a form on non-invasive brain stimulation called transcranial magnetic~     stimulation to understand 1) understand how the brain learns post-stroke and 2) assess~     non-invasive brain stimulation as an addition to current stroke rehabilitation approaches. In~     two study arms the investigators will compare the effect of active transcranial magnetic~     stimulation paired with motor practice with placebo (or sham) transcranial magnetic~     stimulation paired with the same motor practice.~   "
36676|NCT03086538|"~     This study is single center single arm prospective phase II study. In this study, efficacy~     and side effects of pemetrexed as salvage regimen on patients who failed all standard~     chemotherapy and total of 29 patients will be enrolled. Pemetrexed will be continued until~     disease progression is happened.~   "
36677|NCT03086525|"~     Musculoskeletal pain is highly prevalent, disabling, and with high socio-economic costs, with~     many negative effects on quality of life. It affects the ability to perform work, social,~     recreational and domestic tasks, changing the mood and concentration of this population.~     Despite the worldwide prevalence and socioeconomic burden of this condition, a clear~     understanding of its etiology and pathogenesis remains elusive.~      Aims:~      (i) to analyze the possible level of association between fear of pain, fear of movement,~     self-efficacy, and pain acceptance on pain-disability at the start of the study and~     prospectively evaluate its role as a risk factor; (ii) to evaluate the possible role as a~     prognostic factor of fear of pain, fear of movement, self-efficacy and pain acceptance in~     those who develop musculoskeletal pain at follow-up; (iii) explore the possible mediating~     power of fear of movement and self-efficacy in the relationship between pain-disability; (iv)~     investigate what percentage of the variance accounts for beliefs (fear of pain, fear of~     movement, self-efficacy, and acceptance of pain) in predicting the onset and / or maintenance~     of musculoskeletal pain.~   "
36691|NCT03086343|"~     The comparison of safety and efficacy of upadacitinib versus abatacept in participants with~     rheumatoid arthritis on a stable background conventional synthetic Disease Modifying~     Anti-Rheumatic Drug (csDMARD) who have an inadequate response or intolerance to biologic~     DMARDs.~   "
42093|NCT03015753|"~     The proposed study aims to preliminarily test the effects of a 12-week Tai Chi training on~     the prophylaxis of episodic migraine in Chinese women, and to evaluate the feasibility,~     acceptability, compliance and maintenance of Tai Chi exercise among this population.~   "
36678|NCT03086512|"~     The study was designed by the principal investigator, Dr. Alastair Younger, and the St.~     Paul's Hospital Foot and Ankle Research Group, who will conduct the study. The study is being~     funded by Acumed LLC, the manufacturer of the Health Canada approved Acutrak 2® - 7.5 fully~     threaded screw.~      The purpose of this study is to assess and compare the effectiveness of fully threaded screws~     versus partially threaded screws in subtalar fusion, in order to determine the effect of the~     thread configuration on the success of the fusion procedure.~      Efficacy will be assessed primarily by computed tomography (CT) analysis of percent bone~     bridging across the subtalar joint at both 12 and 24 weeks post-op. Outcome scores will also~     be administered to compare general health and foot function between the two groups at~     baseline and at multiple post-op follow-up visits. Additional resource utilization (i.e.~     additional clinic and/or hospital admissions) will also be compared between the two groups~     post-op.~   "
36679|NCT03086499|"~     The primary objective of this study is to describe the relative distances between patient~     clinical profiles (i.e. patient clustering) in multivariate space.~   "
36680|NCT03086486|"~     To evaluate the efficacy, safety and tolerability of various doses and durations of linezolid~     plus bedaquiline and pretomanid after 26 weeks of treatment in participants with either~     pulmonary XDR-TB, pre-XDR-TB, or treatment intolerant or non-responsive MDR-TB.~   "
36681|NCT03086473|"~     This is a clinical trial which will investigate whether administration of caffeine, a~     respiratory stimulant, to preterm babies soon after birth can prevent the need for a~     breathing tube, or intubation. Many preterm babies who require intubation are intubated soon~     after birth, often within the first few hours. If caffeine is given early enough and is~     sufficient to stimulate effective breathing, perhaps these babies may not require intubation.~     Additionally, caffeine may improve blood flow in preterm babies when given soon after birth.~     Approximately half of babies in this study will receive caffeine within two hours after~     birth, and half will receive caffeine 12 hours after birth. The hypothesis is that preterm~     babies who receive caffeine within 2 hours after birth will have a lower incidence of~     intubation than preterm babies who receive caffeine 12 hours after birth. The main secondary~     hypothesis is that caffeine given soon after birth will enhance blood flow in preterm babies.~   "
36682|NCT03086460|"~     The purpose of this study is to evaluate the dose-response of different doses of CHF 1531 on~     lung function and other clinical outcomes, to identify the optimal dose(s) in terms of~     benefit/ risk ratio for further development in the target subject population.~   "
36683|NCT03086447|"~     Randomized, double-masked, 5-visit, bilateral dispensing, parallel group study to demonstrate~     that the investigational contact lens meets the design requirements related to corneal~     staining, lens fit, visual acuity and rotational performance as well as subjective comfort~     and handling. Subjects will wear the contact lenses for a total of 28-36 days.~   "
36684|NCT03086434|"~     This project will evaluate an after-school substance abuse prevention intervention, compared~     to a standard substance abuse education program, targeting 6th grade AI youth in three AI~     communities: Ojibwe/Chippewa in Minnesota, Choctaw in Oklahoma, and Lumbee in North Carolina.~      A community-based participatory research approach will be used to culturally and~     technologically adapt the intervention. A two-condition controlled study will evaluate the~     efficacy of the intervention to increase AI youth Native self-reliance while decreasing AI~     youth substance use involvement. An adult training program second level intervention study~     will also be implemented to train tribal personnel from the three regional tribes on how to~     implement the intervention as a tribal program beyond the study period.~      Effectiveness will be determined by a small partial cross-over randomized trial comparing the~     intervention to a wait-list control condition. Process evaluations will focus on the future~     adoption and implementation of the intervention, and recommendations for sustainable~     adaptations.~   "
36685|NCT03086421|"~     Many children with cancer are diagnosed in early childhood, and as such, will likely miss key~     social experiences such as participation in preschool or kindergarten, playing on~     playgrounds, and other normative experiences. In typically-developing children, it is known~     that these experiences - and the skills that are learned during them - are critical to later~     well-being. Very little is known about the psychological functioning of young children with~     cancer, as studies have predominantly focused on those who are older (at least 8 years of~     age). This study will explicitly assess social functioning in preschool-aged children with~     cancer and follow the development of their social functioning from the end of treatment into~     survivorship.~      The goals of this pilot study are to begin to assess the impact of missed early childhood~     social experiences, as well as the interaction with developing neurocognitive problems.~      PRIMARY OBJECTIVE: Explore the impact of cancer in the central nervous system on social~     functioning of young children (ages 4-6) after completion of therapy.~   "
36686|NCT03086408|"~     The purpose of this study is to investigate whether diagnostic bronchoscopy can be safely and~     potentially more effectively performed without the use of tracheal intubation or a~     supraglottic airway, under completely unobstructed surgical conditions afforded by THRIVE:~     Transnasal Humidified Rapid- Insufflation Ventilatory Exchange. THRIVE provides patient's gas~     exchange through rapid insufflation of high-flow oxygen via specialized nasal cannula.~   "
36687|NCT03086395|"~     Patients with post transplant lymphoproliferative disorder (PTLD) that have been treated with~     at least one type of chemotherapy, but whose lymphoma is not responding or coming back after~     the previous treatment will be asked to participate in this study.~      This clinical trial uses a drug called Obinutuzumab. The Food and Drug Administration (FDA)~     has approved Obinutuzumab for sale in the United States for certain diseases. Obinutuzumab is~     still being studied in clinical trials to learn more about what its side effects are and~     whether or not it is effective in the disease or condition being studied. Obinutuzumab is~     considered an investigational drug in this study~      Obinutuzumab (GA101) is an antibody directed against cluster of differentiation antigen 20~     (CD20). Antibodies are protein that are part of the immune system that can target cancer~     cells. Obinutuzumab sticks to a target called CD20. CD20 is an important molecule on some~     cancer cells (including non-Hodgkin lymphoma) and some normal cells of the immune system.~      This study is being done to test if the study drug has an effect on post transplant~     lymphoproliferative disorder and to see how lymphoma will respond to the study drug.~   "
36688|NCT03086382|"~     The purpose of this study is to demonstrate bioequivalence between the LCM tablet and syrup~     after single oral dosing in healthy Chinese male subjects.~   "
36692|NCT03086330|"~     This trial is conducted in Asia, Europe and North America. The aim of the trial is to compare~     the effect of semaglutide s.c. 1.0 mg once-weekly versus placebo as add-on to sodium glucose~     co-transporter-2 inhibitor (SGLT-2i) monotherapy or in combination with either metformin or~     sulfonylurea on glycaemic control after 30 weeks of treatment in subjects with type 2~     diabetes. Subjects will remain on their pre-trial medication.~   "
36693|NCT03086317|"~     The study is an investigator-initiated trial comparing two different catheters (standard~     versus ultrasound assisted) for the treatment of acute high risk pulmonary embolism (blood~     clots in lung arteries with evidence or heart strain). Patients already planned for the~     procedure will be randomized to standard catheter-directed thrombolysis (CDT) or to~     ultrasound-assisted catheter thrombolysis (USAT). Both catheters are currently used routinely~     in practice for the treatment of pulmonary embolism, but it is not known if USAT is superior~     to standard CDT, the former being much more expensive and more commonly used.~      The purpose of the study is to learn about which catheter-directed therapy is more suitable~     for patients with pulmonary embolism (PE), who are candidates for both standard catheter~     directed therapy (CDT), and ultrasound-assisted catheter directed therapy (USAT), and to~     provide information regarding the cost effectiveness of the two different types of treatment.~     A total of 80 patients are planned to be recruited. All medication administration, procedures~     or in-hospital tests will be performed as routine clinical practice. The study will compare~     short term and long term outcomes: resolution of blood clots on CT scan, right ventricular~     size improvement, quality of life and symptoms at 3 and 12 months, and cost effectiveness.~   "
36694|NCT03086304|"~     Postoperative intestinal obstruction is one of the most common complication of~     gastrointestinal surgery, some research have confirmed that transcutaneous acupoint~     electrical stimulation (TEAS) can promote recovery of gastrointestinal function, reduce the~     incidence of postoperative nausea and vomiting, our goal is to investigate the effectiveness~     of TEAS in reducing the incidence of gastrointestinal obstruction after operation in~     perioperative.~   "
36695|NCT03086291|"~     Simvastatin 5-10mg/kg bid for 7 days and 14 days off treatment for 21 days Cohort 1: 7.5~     mg/kg bid for 7 days 14 days off Cohort 2: 10 mg/kg bid for 7 days 14 days off Cohort 3: ( )~     mg/kg bid for 7 days 14 days off (to be determined based on PK data of cohort 1 and 2) Q 3~     weeks~   "
36696|NCT03086278|"~     AST-008 will be dosed subcutaneously to healthy volunteers in a combined SAD/MAD study to~     evaluate its safety, tolerability, pharmacokinetics and pharmacodynamics.~   "
36697|NCT03086265|"~     The purpose of this study is to investigate whether laser laryngeal surgery can be safely and~     potentially more effectively performed without the use of tracheal intubation or jet~     ventilation, under completely tubeless conditions. The patient's gas exchange will be~     supported by rapid insufflation of high-flow oxygen through specialized nasal cannula: the so~     called Transnasal Humidified Rapid- Insufflation Ventilatory Exchange (THRIVE).~   "
36698|NCT03086252|"~     This pilot study evaluates safety of administration of red blood cell transfusions requested~     by patients based on their symptoms instead of levels of hemoglobin for the treatment of~     chronic anemia in patients with blood disorders.~   "
36699|NCT03086239|"~     This is a Japanese, multicenter, open-label, dose-escalation study. This is the first study~     to assess the safety and tolerability as well as explore the pharmacokinetics,~     pharmacodynamics and antitumor activity of rovalpituzumab tesirine in Japanese participants~     with advanced small cell lung cancer (SCLC).~   "
36700|NCT03086226|"~     This study is a single-center, comparative, randomized, double-blind, parallel-group,~     active-controlled, clinical superiority trial of Fosravuconazole versus Itraconazole combined~     with surgery in subjects with eumycetoma in Sudan.~      There will be three arms in this study: The first arm will be Fosravuconazole 300 mg weekly,~     the second arm will have Fosravuconazole 200 mg weekly and the control arm is the standard~     treatment using itraconazole 400mg daily.~      At 3 months time-point, interim analysis will be done and one of the study arms will be~     dropped according to the drop-the-loser design, based on efficacy or toxicity.~   "
36701|NCT03086213|"~     The aim of this study is to study the safety and effectiveness of the effects on the~     perioperative pain control comparing between the thoracic paravertebral nerve block using the~     camera guided and the intrathoracic intercostals nerve block for the management of~     nonintubated local regional analgesia in uniport thoracoscopic surgery for the undetermined~     solitary nodules patients.~   "
36702|NCT03086200|"~     CCTG 603 is an open-label, two-arm, randomized (1:1) clinical demonstration project to~     determine if brief Motivational Interviewing (MI-B) added to a text-message based adherence~     intervention (iTAB) improves adherence to PrEP among transgender persons.~   "
36703|NCT03086187|"~     11 healthy men used the HEPHAISTOS unloading orthosis in an ambulatory 8 week intervention~     study.~      It greatly reduces calf muscle forces without reducing ground reaction forces.~   "
36704|NCT03086174|"~     This is a phase Ib, open, mono-center, dose-escalation, tolerability and pharmacokinetic~     study evaluating the Recombinant Humanized Anti-PD-1 mAb for Injection in combination with~     Axitinib in patients with advanced kidney cancer and melanoma who have failed in routine~     systemic treatment.~   "
36705|NCT03086161|"~     50-70% of adolescents gain too much weight during pregnancy, and this excess gain~     significantly increases their risk of high postpartum weight retention and long-term obesity.~     In this randomized controlled pilot study, the investigators are evaluating the feasibility~     and acceptability of a relatively brief interpersonal psychotherapy program for reducing~     excess gestational weight gain during adolescent pregnancy. Compared to treatment-as-usual~     prenatal care delivered in an adolescent maternity clinic, the investigators will estimate~     the added benefit of an interpersonal psychotherapy program's effectiveness for reducing~     excess gestational weight gain, improving maternal postpartum insulin sensitivity, and~     decreasing maternal and infant adiposity.~   "
36717|NCT03086005|"~     This study was performed to investigate the effects of metformin on controlled ovarian~     stimulation (COS), in vitro fertilization (IVF) outcomes, pregnancy outcomes, and comparison~     of serum and follicular fluid cytokines and hormones in patients with polycystic ovary~     syndrome (PCOS) undergoing IVF using gonadotropin-releasing hormone(GnRH) antagonist~     protocol.~   "
42106|NCT03015584|"~     This study will use systems biology techniques, especially RNA-seq, to understand cognitive~     impairment after sepsis requiring an intensive care unit (ICU) admission.~   "
36706|NCT03086148|"~     Perioperative depression symptom (PDS) is one of the common mental comorbidity, and~     influences the clinical outcomes and prognosis. However, there is no rapid acting treatment~     to deal with it during the limited hospital stay. This study aims to determine whether~     ketamine could improve the depressive symptom of peirioperative patients. It will also~     examine the safety for administrating ketamine as an antidepressant intraoperatively.~     Meanwhile, it will show if ketamine could improve anxiety, postoperative pain or delirium.~     This trial also will bring great concerns on patients with perioperative mental health and~     explore the measures to improve their psycho-related prognosis.~   "
36707|NCT03086135|"~     To study the initial experience with implanting and fitting the new Bone conduction system in~     patients with conductive, mixed or Single sided Sensorineural deafness.~   "
36708|NCT03086122|"~     The syndrome of obstructive sleep apnea (OSA) is a common condition that affects 2-4% of the~     general population, causing an increase in sympathetic activity, changes in systemic blood~     pressure, and is associated with cardiovascular disease. The pathophysiological mechanisms~     that are altered as a result of the events associated with obstructive sleep apnea~     (hypoxia-reoxygenation, arousals and sleep fragmentation), are associated with an increased~     risk of developing erectile dysfunction in patients with Obstructive Sleep Apnea. Until~     today, the studies linking Erectile Dysfunction with Obstructive Sleep Apnea (OSA) are~     epidemiological studies.~      The alterations in the expression profile of endothelial and cardiovascular dysfunction~     biomarkers and sex hormones disorders that are altered as a result of the events associated~     with OSA are associated to erectile dysfunction development.~      Treatment with continuous positive airway pressure (CPAP) reverses the effects of OSA and~     patients with erectile dysfunction may improve erectile function.~      The primary objective of the study is:~      1. To evaluate the impact of CPAP treatment on erectile dysfunction in OSA patients.~      The secondary objectives are:~        1. To determine the profile of synthesis of different biomarkers related to endothelial~          dysfunction and cardiovascular disorder, which are altered as a result of the syndrome~          of obstructive sleep apnea and its relation to the risk of developing erectile~          dysfunction.~        2. To compare the secretion profile of sex hormones related to control erectile function in~          a group of patients with syndrome of obstructive sleep apnea with and without erectile~          dysfunction.~        3. To assess the prevalence of erectile dysfunction in patients with OSA.~        4. To compare the psychological profile of patients with OSA with and without erectile~          dysfunction in order to detect psychological distress associated with the risk of~          developing erectile dysfunction.~        5. To evaluate the impact of CPAP treatment on the secretion profile of sex hormones~          related to control erectile function in OSA patients.~        6. To evaluate the impact of CPAP treatment on the psychological profile of patients with~          erectile disfunction in OSA patients.~   "
36709|NCT03086109|"~     The purpose of this observational study is to investigate the prevalence and risk factors of~     bone degenerative diseases~   "
36710|NCT03086096|"~     The application of transarterial chemoembolisation (TACE) using LifePearl Microspheres loaded~     with Irinotecan in liver-only or liver-dominant metastatic disease in patients with~     colorectal adenocarcinoma will be observed. The registry has the following objectives:~        1. map the exact indications that the device is being used for and at which stage in~          treatment it is being applied~        2. to assess observed treatment outcomes in terms of safety and efficacy as well as trying~          to determine any predictive response factors~   "
36711|NCT03086083|"~     Comparatively studied the effects of Eye Movement Desensitization and Reprocessing (EMDR)~     bilateral brain stimulation in trauma therapy.~      A randomized, parallel, before-after, blind study was performed.~   "
36712|NCT03086070|"~     The hypothesis of this study is that a gastroesophageal reflux recommended treatment with~     proton pump inhibitor (dose and duration) compared to placebo significantly reduces both the~     signs and symptoms of laryngopharyngeal reﬂux and comorbid chronic rhinosinusitis. Primary~     objective was to determine whether 8 weeks of treatment with omeprazole 20 mg ones daily (OD)~     significantly reduces the signs and symptoms of laryngopharyngeal reﬂux when compared to~     placebo in patients with laryngopharyngeal reﬂux with comorbid chronic rhinosinusitis.~     Secondary objectives were to determine whether 8 weeks of treatment with omeprazole 20 mg OD~     significantly reduces the signs and symptoms of comorbid chronic rhinosinusitis in patients~     with laryngopharyngeal reﬂux when compared to matching placebo; and to investigate the~     association of the severity of signs and symptoms of laryngopharyngeal reﬂux with the ones of~     chronic rhinosinusitis in the same group of patients. The research was carried out as a~     double blind randomized placebo controlled trial. Patients were randomized into two groups in~     an approximate 1:1 ratio using a concealed random sequence. After randomization and initial~     assessment treatment was initialized. Patients on active treatment were given omeprazole 20~     mg once daily half an hour before breakfast for 8 weeks, while those in the placebo group~     were given matching placebo tablets using the same regimen for 8 weeks as the group on the~     active treatment. Patients were reassessed at the end of treatment for signs and symptoms of~     laryngopharyngeal reﬂux and comorbid chronic rhinosinusitis.~   "
36713|NCT03086057|"~     PrEPare for Work is a two-stage randomized controlled pilot trial which utilizes a~     behavioral intervention to optimize the uptake and adherence of Pre-exposure Prophylaxis~     (PrEP) in Male Sex Workers (MSW).~   "
36714|NCT03086044|"~     This is an open-label, pilot safety and efficacy trial for adults who are active on the heart~     or lung transplantation lists and are eligible to receive an organ from an increased risk~     donor who has evidence of active or prior hepatitis C infection (HCV).~   "
36715|NCT03086031|"~     An acquired brain injury (ABI) is a complex injury often followed by a broad range of~     cognitive, physical, emotional, and behavioral disabilities. Because of these disabilities,~     vocational rehabilitation (VR) is a challenging task, however, of great importance, since~     approximately 75% of the patients with ABI are of working age. Thus, standardized clinically~     effective and cost-effective methodologies regarding VR for patients with ABI are highly~     needed.~      This study is an interventional, two-arm, 6-month follow-up, cluster randomized controlled~     trial involving four municipalities in the Zealand Region and the Capital Region of Denmark.~     A total of 84 patients with ABI evenly distributed across four municipalities will be~     included in the study. The patients will randomly be allocated in a 1:1 ratio to the VR~     intervention provided by a specialized Brain Injury Centre or the conventional VR provided by~     the municipalities (usual care). The 6-9 month intervention will consist of individual and~     group therapies as well as a work placement program including supported employment.~     Furthermore, the intervention will include a family intervention program followed up by~     support to one individual family caregiver. The primary outcomes are increased work or study~     rate at 6-month follow-up. Moreover, a budget impact analysis and possibly a cost utility~     analysis of the intervention will be performed The program is one of the first to include a~     comprehensive and target VR intervention including multiple parties such as the~     municipalities, a specialized rehabilitation team, and patients' own family caregivers. If~     this intervention is proven successful when compared to the conventional VR, it will provide~     evidence for a manual-based individualized holistic approach in returning to work after an~     ABI.~      The first hypothesis of the study is that more participants allocated to the VR intervention~     group will have a significant higher employment/study rate (measured in hours) at 6-month~     follow-up when compared to participants receiving the conventional VR program provided by the~     municipalities (control group). The second hypothesis is that health-related quality of life~     (HRQoL) and disability among the participants as well as the HRQoL and caregiver burden among~     the caregivers are significantly improved at the end of the VR intervention and at 6-month~     follow-up when compared to the conventional VR program. Finally, a budget impact and possibly~     a cost utility analysis will be performed.~   "
36716|NCT03086018|"~     The aim of this study is to investigate the performance of the hearing aid under laboratory~     as well as everyday conditions. In addition, the performance data of the hearing aid are~     compared with a Bernafon hearing aid already available on the market.~      The hearing aids are adapted according to the user requirements. The data collected in the~     study is intended to show that the benefit of the hearing aid being examined is identical or~     better than the current CE-marked hearing aid. A further aim is to improve the adaptation of~     the hearing device in such a way that the benefit for people with hearing impairments can be~     increased.~   "
36718|NCT03085992|"~     This study includes patients affected by advanced and resectable rectal adenocarcinoma. It~     provides an induction chemotherapy with FOLFOXIRI regimen plus Bevacizumab followed by~     Chemoradiotherapy plus Bevacizumab. Surgery with total mesorectal incision must be performed~     within 7-9 weeks after this last treatment. The protocol will be evaluate the disease free~     survival at two years. Translational analyses will be performed to show the presence of VEGF~     polymorphism, CD133 surface markers on colorectal CSCs.~   "
36719|NCT03085979|"~     Surgical management of mixed urinary incontinence~   "
36720|NCT03085966|"~     Study of autologous immune cell therapy in combination with the luteinizing hormone releasing~     hormone agonists (LHRH-a) in patients with metastatic castration-resistant prostate cancer~   "
36721|NCT03085953|"~     The Study for Employment Retention of Veterans (SERVe) is a randomized controlled trial,~     available exclusively to Oregon employers of veterans. It is designed to develop and~     scientifically evaluate Veteran-supportive supervisor training (VSST) that may enhance~     retention of veterans, with the goal of improving workplace culture and general well-being to~     our service members. The intervention, applied to workplace supervisors, will be measured by~     experience of veterans, assessing workplace experiences, health, well-being, as well as~     employees' spouse/partners' family experiences, health and well-being, and workplace~     outcomes.~   "
36722|NCT03085940|"~     Rheumatoid arthritis (RA) increase cardiovascular risk and endothelial dysfunction.~     Hydroxychloroquine (HCQ) is expected to improve endothelial dysfunction through some~     metabolic effects. The investigators intend to find the role of HCQ to improve endothelial~     dysfunction in RA patients. This study will also evaluate correlation HOMA-IR (homeostasis~     model assessment-estimated insulin resistance), FFA (free fatty acid) and ox-LDL~     (oxidized-LDL) level change, with endothelial dysfunction improvement.~   "
36723|NCT03085927|"~     Music therapy, a frequently used arts-based therapy, has become standard palliative care in~     many pediatric and adult hospitals; however, few studies have examined the mechanisms by~     which music therapy interventions work. This study investigates behavioral, social, and~     psychological factors that may explain how an Active Music Engagement (AME) intervention~     (i.e., an interactive, music-based play intervention) works to manage emotional distress and~     improve positive health outcomes in parents and young children with cancer during treatment.~     Findings will provide scientific and clinically relevant practice knowledge to guide delivery~     of music therapy as a complementary therapy.~   "
36724|NCT03085914|"~     This is an open-label, nonrandomized, Phase 1/2 study in subjects with advanced or metastatic~     solid tumors. Phase 1 is an assessment to evaluate the safety and tolerability of epacadostat~     when given in combination with pembrolizumab and chemotherapy. Once the recommended doses~     have been confirmed, subjects with advanced or metastatic CRC, PDAC, NSCLC (squamous or~     nonsquamous), UC, SCCHN or any advanced or metastatic solid tumor who progressed on previous~     therapy with a PD-1 or PD-L1 inhibitor will be enrolled in Phase 2.~   "
36725|NCT03085901|"~     This study is to compare the clinical outcome of Precizon toric intraocular lens(IOL) to that~     of Tecnis toric IOL.~   "
36726|NCT03085888|"~     GRAIL is using high-intensity sequencing of circulating cell-free nucleic acids (cfNAs) to~     develop blood tests to detect cancer early. The purpose of this study is to train and~     validate an assay to detect invasive breast cancer in patients undergoing mammography.~   "
36727|NCT03085875|"~     This study will take advantage of the open source framework of ResearchKit developed by Apple~     to bring research directly to participants. Using the ResearchKit platform makes it easier to~     enroll large numbers of participants and carry out real-world health research to answer~     questions important to a broad population.~   "
36728|NCT03085862|"~     Aim. To investigate whether lung ultrasound can be used to detect extravascular lung water~     (EVLW) overload in the intensive care unit early after surgery.~      Methods. This prospective study involved 60 patients without known cardiac or pulmonary~     diseases admitted to the intensive care unit at our hospital after elective abdominal or~     vascular surgery. The inferior vena cava collapsibility index (IVCcl), oxygen partial~     pressure (PaO2) and inspired oxygen pressure (FiO2) ratio (PaO2/FiO2), and appearance of~     B-lines ≤7 mm were determined upon admission to the intensive care unit and at 6, 12, and 24~     h later. Fluid overload was defined as IVCcl ≤ 40% and the presence of B-lines ≤7 mm. Tissue~     oxygenation impairment was defined as a PaO2/FiO2 ratio < 200.~   "
36729|NCT03085849|"~     Primary Objectives~      Dose escalation phase:~      • To estimate the maximum tolerated dose of SGI-110 when given prior to durvalumab and~     tremelimumab, as determined by the rate of DLT~      Dose expansion phase:~      • To estimate the rate of treatment related adverse events for combination therapy with~     SGI-110 (at the MTD), durvalumab, and tremelimumab in order to guide phase 2 trial design~      Secondary Objectives~      Both phases:~        -  To measure changes in expression levels of predicted neoantigens before and after~          epigenetic therapy with SGI-110 by performing WES and RT-PCR on tumor biopsies~        -  To estimate overall response rate (ORR), median duration of response (mDOR), median~          progression-free survival (mPFS), and median overall survival (mOS) with this treatment~   "
36730|NCT03085836|"~     The purpose of this study is to determine the pharmacokinetics (PK) of TAK-438 in healthy~     adult Chinese participants after both single and multiple dose administration.~   "
36731|NCT03085823|"~     The purpose of this study is to observe and evaluate the performance of a Sirolimus-eluting~     Drug Coated Balloon for the treatment of any type of coronary lesions, including native~     vessel disease and in stent restenosis.~   "
36732|NCT03085810|"~     This is a prospective, multicenter, open-label, single-arm, phase 3b study which evaluates~     effectiveness and safety of ocrelizumab in participants with early stage RRMS. The study will~     consist of an open-label treatment period of 192 weeks and follow-up period of at least 48~     weeks.~   "
36758|NCT03085472|"~     The Chongqing intracerebral hemorrhage study is a multi-center, prospective, observational~     study led by professor Qi Li from Chongqing Medical University. Professor Peng Xie will be~     the senior consultant for the study. The Chongqing intracerebral hemorrhage study will focus~     on the epidemiology, natural history, pathogenesis, laboratory, radiological aspects,~     clinical outcomes and the effects of treatment in patients with intracerebral hemorrhage.~      The clinical, laboratory, imaging, genetic and outcome data of patients diagnosed with acute~     intracerebral hemorrhage will be prospectively collected. The prognosis of patients with~     intracerebral hemorrhage will be assessed by using several outcome measure scales at~     different time points.~   "
36733|NCT03085797|"~     Nasal polyps (NP) has long been known as chronic inflammatory disease of the nasal mucosa.~     This disease is characterized by the presence of polyps in the upper nasal cavity,~     originating from within the ostiomeatal complex. The presence of polyps can cause long-term~     symptoms such as prominent nasal obstruction, post-nasal drip, loss of smell, and discharge.~      Mepolizumab (SB240563) is an Immunoglobulin G 1 [IgG1], kappa humanized monoclonal antibody~     (mAB) that blocks human interleukin-5 (hIL-5) from binding to the interleukin-5 (IL-5)~     receptor complex expressed on the eosinophil cell surface and thus inhibits signaling.~     Neutralization of IL-5 with mepolizumab has been shown to reduce blood, sputum and tissue~     eosinophils and hence is assumed to be a treatment option in a number of eosinophilic~     diseases including NP.~      The aim of this randomized, double-blind, parallel group, phase 3 (PhIII) study is to assess~     the clinical efficacy and safety of 100 milligram (mg) subcutaneous (SC) mepolizumab as an~     add on to maintenance treatment in adults with severe bilateral NP. The study will include a~     4-week run in period followed by randomization to a 52-week treatment period. Participants~     will receive mepolizumab 100 mg or placebo SC by the investigator or delegate via a~     pre-filled safety syringe every 4 weeks for 52 weeks. Throughout the entire study period (run~     in + treatment period + follow up), participants will receive a standard of care (SoC) for NP~     which consists of daily mometasone furorate (MF) nasal spray, and if required, saline nasal~     douching, occasional short courses of high dose oral corticosteroids (OCS) and/or~     antibiotics. The treatment period will consist of thirteen, 4-weekly doses of mepolizumab or~     placebo. In addition, up to the first 200 randomized participants will be followed up every~     other month for up to a further 6 months after the Visit 15 (7 months post last dose) in~     order to assess maintenance of response and to validate a physiological model derived from~     the previous Phase 2 study. Approximately 400 participants will be randomized (200~     participants per treatment arm) in to the study. Total duration of the study will be 76 weeks~     for first 200 randomized participants and 52 weeks for remainder of participants who are not~     participating in the 6 months no treatment follow up.~   "
36734|NCT03085784|"~     The ARRT trial will assess the safety and efficacy of 2mg aflibercept for the treatment of~     radiation retinopathy, including maculopathy and optic neuropathy over 52 weeks.~   "
36735|NCT03085771|"~     The general aim of this study is to investigate the influence of systemic administration of~     Desferal (Deferoxamine [DFO]) on the response to hypoxic challenge in patients with diabetes~     mellitus (DM).~      The investigation will elucidate if DFO can restore:~        -  the impaired angiogenetic response to hypoxia in patients with type 1 DM.~        -  the disturbed respiratory and cardiovascular regulation in response to hypoxia in~          patients with DM type 1~   "
36736|NCT03085758|"~     This is a double-blind, placebo-controlled, randomized, multicenter proof of concept and~     dose-finding phase II study using two doses of ADRECIZUMAB in patients with early septic~     shock and a bio-ADM plasma concentration at admission of > 70 pg/ml.~   "
36737|NCT03085745|"~     Writer's cramp (WC) is a form of focal dystonia, a movement disorder characterized by~     sustained or intermittent muscle contractions causing abnormal, often repetitive movements,~     postures, or both. It typically manifests while writing, making handwriting impossible in the~     most severe cases. Treatment can be difficult, but one effective and well-tolerated treatment~     consists in local muscle injections with botulinum toxin. Although clinical improvement seems~     to be related to focal muscle chemodenervation, central plasticity changes may occur. The~     main aim of the study is to characterize and quantify the changes in intrinsic hand muscle~     cortical representations at rest and during isometric contractions of the finger muscles~     before and after treatment with botulinum toxin and the changes in sensorimotor integration~     in patients with writer's cramp.~   "
36738|NCT03085732|"~     The objective of this prospective randomised clinic study is to investigate the effect of~     peritoneal cavity saline irrigation during abdominal hysterectomies on postoperative~     infectious morbidities and gastrointestinal disturbance. The participants will be randomised~     to either an irrigation of abdominal cavity or the control group after vaginal closure.~     Assignment to one of the two treatment groups will be determined using a computer generated~     random numbers. Primary outcome is the rate of postoperative infectious morbidities.~     Secondary outcome is the rate of gastrointestinal disturbances (nausea, vomiting), use of~     antiemetic drugs and pain score in the postoperative period. 100 patients in each treatment~     arm planned.~   "
36739|NCT03085719|"~     This research study is studying immunotherapy in combination with radiation therapy as a~     possible treatment for head & neck cancer that has worsened or spread to another organ or~     part of your body.~      The immunotherapy involved in this study is: MK-3475 (pembrolizumab or KEYTRUDA).~   "
36740|NCT03085706|"~     To assess the safety of peripheral blood mononuclear cell transplantation into the~     subarachnoid space for the treatment of amyotrophic lateral sclerosis.~   "
36741|NCT03085693|"~     Closure of the left atrial appendage in patients with atrial fibrillation and risk for stroke~     is a increasing technology leading to exclusion of the left atrial appendage volume from the~     blood circulation and therefore protects from cardioembolic strokes- It is unclear if the~     volume reduction of the left atrium leads to a change in exercise capacity or Quality of~     life.~   "
36742|NCT03085680|"~     This placebo-controlled RCT tests whether dietary supplementation with curcumin maintains or~     improves cognitive and physical function in older adults who are at high risk of functional~     decline due existing (mild) functional impairments and elevated biomarkers of inflammation~     and explore the association between functional changes and changes in biological indicators~     of active inflammation.~   "
36743|NCT03085667|"~     Closure of the LAA by several devices is a alternative therapy to oral anticoagulation in~     patients with Atrail fibrillation. Nothing is known about the acute influence of a device~     closure of the LAA on the secretion of ANB nad BNP hormones. Therefore aim of our study is to~     measure ANB and BNP levvels before and after Implantation of an LAA closure device.~   "
36744|NCT03085654|"~     To examine whether multiple doses of oxytocin have different effects on behavior and neural~     indices in males with high or low trait anxiety.~   "
36745|NCT03085641|"~     To investigate whether nHFT is an effective treatment for patients with Chronic Heart Failure~     (CHF) and central sleep apnea (CSA).~      This study is a prospective one armed uncontrolled intervention pilot study investigating 4~     weeks of nHFT at home in 10 patients with CHF and CSA.~   "
36746|NCT03085628|"~     The aim of the present study is to examine whether the neuropeptide oxytocin (OXT) influences~     social reward processing and whether the effects are context- and sex-dependent.~   "
36771|NCT03085303|"~     Multicentric, placebo‐controlled, double‐blinded, three‐armed, prospective, randomized~     controlled trial.150 patients diagnosed with atopic dermatitis will be randomized to arm 1~     (irradiation for 30min at 415nm wavelength), arm 2 (irradiation for 30min at 450nm~     wavelength), and arm 3 (irradiation for 30min at low‐dose (placebo)). Irradiation will be~     scheduled 3 times a week for 8 weeks. Patients will be followed up for four weeks after the~     last irradiation.~   "
36747|NCT03085615|"~     The FEDOX trial is a prospective randomized clinical trial exploring oxidative stress as a~     mechanism of harm to explain the negative outcomes found in feeding trials that achieved~     caloric exposure commensurate with the nationally recommended guidelines. Due to its impact~     on energy metabolism, we will also explore low T3 syndrome's relationship to this mechanism.~     Finally, we will explore circadian patterns of diurnal/nocturnal TSH fluctuation as a~     potential biomarker to indicate this mechanism of harm has subsided.~      This 7-day prospective randomized clinical trial is designed to address the following~     specific aims (SA) in ICU patients (n=40) with systemic inflammatory response syndrome.~      SA1) Determine whether provision of enteral nutrition (EN) at 100% of levels in Nationally~     Recommended Guidelines NRG (25-30 kcals/kg, 100%NRG) early in critical illness increases~     reactive oxygen species (ROS) production compared to EN at 40% of NRG levels (10-12 kcals/kg,~     40%NRG). Subjects will be fasted overnight and randomized to receive either 100% NRG or~     40%NRG for 7 days. Plasma F2-isoprostanes will be measured daily and compared between groups~     through repeated measures analysis.~      SA2) Determine if EN at 100%NRG interrupts the critical illness induced low T3 syndrome and~     subsequently further increases the ROS production compared to 40%NRG. Serum thyroid~     parameters (T3, T4, rT3, TSH) with be measured daily and compared between groups as above.~      Mediation analysis will be used to determine the proportion of the effect of nutrition group~     on F2-isoprostane production explained by each thyroid parameter.~      SA3) Determine if the return of diurnal/noctural fluctuations in TSH is associated with~     decreased nutrition-induced ROS production. Plasma TSH will be measured twice per day at 0300~     and 1800hrs to determine TSH fluctuation. The interaction effect between TSH fluctuation and~     nutrition group on F2-isoprostane production will be assessed through repeated measures~     analysis. This study provides vital mechanistic insight into the impact of feeding on~     oxidative stress during the first week of critical illness, represents an important first~     step in determining the safest timing and dosage of nutrition support, and sets the~     foundation for future larger clinical trials on these topics.~   "
36748|NCT03085602|"~     The purpose of this research study is to examine changes in brain regions associated with~     cognitive control and reward processing during behavioral smoking cessation treatment.~   "
36749|NCT03085589|"~     This study aims to adapt a mobile health device (Amulet) for use in older adults. It is the~     second in a series of four research studies whose overarching goal is to conduct a program of~     pilot research aimed at developing and evaluating a technology-assisted wellness intervention~     for older adults with obesity who may or may not live in a rural area.~   "
36750|NCT03085576|"~     A non-interventional, national longitudinal study of atrial fibrillation performed with 91~     cardiologists.~   "
36751|NCT03085563|"~     The objective of this project is to compare the sedative effects of intranasal midazolam~     versus inhaled nitrous oxide (N2O) for minor procedures in the pediatric emergency~     department. The primary outcome will be length of stay (LOS) in the emergency department (ED)~     stay for minor procedures. Secondarily the investigators will compare patient/family and~     provider satisfaction while using either intranasal midazolam or N2O for minimal sedation.~     The investigators hypothesize that the total length of stay for children undergoing minor~     procedures in the ED will be lower for N2O, as compared to intranasal midazolam. The~     investigators also hypothesize that patient/family and provider satisfaction will be higher~     with N2O and adverse effects will not differ between N2O and intranasal midazolam. Patients~     will receive either intranasal midazolam or N2O for minor procedures. Following the~     enrollment period, data will be analyzed and the two will be compared. Total length of stay,~     patient/family and provider satisfaction will be studied.~   "
36752|NCT03085550|"~     Conventional management of diabetic ulcers is associated with slow healing, high costs and~     repeated trips to clinic. Stem cells contained in fat grafts can differentiate into~     pro-healing cells and release growth factors with evidence suggesting a benefit in wound~     healing. Platelet-rich-plasma (PRP), an autologous blood-product, demonstrates pro-healing~     properties through releasing pro-healing factors and regulating angiogenesis. When used~     combination there is evidence of additional wound healing benefits.~      The aim is to investigate the rate of wound healing in diabetic ulcers when treated with~     conventional dressings, fat grafting alone and fat+PRP combination. The secondary aims will~     be to understand the mechanism of the healing process, the health related quality of life and~     patient satisfaction and the cost implications.~      The study is a single-blinded randomised controlled trial of 30 patients with three parallel~     treatment arms. Each patient will be followed up for 12 weeks and the rate and degree of~     wound healing will be assessed. Wound biopsies will be taken at Day 0, week 1 and week 4 and~     will undergo subsequent histological analysis to evaluate the mechanism of healing. The study~     is expected to last two years from recruitment of the first patient and will be conducted at~     Royal Free Hospital and UCL Division of Surgery and Interventional Science.~      The combination of fat+PRP may provide diabetic patients the option of a single treatment~     with improved healing, shorter followup and a reduced cost burden. Validation of the~     mechanism of healing through histological analysis will confirm clinical findings and help~     guide future research.~   "
36753|NCT03085537|"~     The main objective will be to determine the effectiveness of home non-invasive ventilation by~     flow-time and time-pressure curves analysis in a cohort of patients with this treatment by~     digital diagnosis platform.~   "
36754|NCT03085524|"~     The presence of foot symptoms at rest or tissue necrosis in patients with peripheral artery~     disease is a medical urgency and represents a state of critical limb ischemia (CLI) where the~     risk of amputation, in the absence of revascularization, is high. No trial conducted to date~     in peripheral revascularization has determined the effect of diabetes on mechanism of~     revascularization failure. Therefore, this trial represents a unique opportunity to~     investigate the mechanisms by which diabetes affects surgical and endovascular~     revascularization procedures with the long-term goal of improving outcomes in CLI.~   "
36755|NCT03085511|"~     The purpose of this study is to determine if, in presence of a reduced calorie diet, a~     breakfast containing high quality protein source (eggs) would be more effective in reducing~     hunger and increasing feeling of fullness compared to a breakfast containing a lower quality~     of protein, but equal energy density. A previous pilot study with the same endpoints yielded~     borderline significant results; this study has been powered based on that pilot to~     interrogate our hypotheses.~   "
36756|NCT03085498|"~     The study resembles a four-year follow-up on the influence of physical activity and fitness,~     blood pressure, BMI and stress on vascular health in primary schoolchildren. It examines the~     predictive value of retinal vessel diameters for the development of childhood hypertension.~   "
36757|NCT03085485|"~     The study is a Phase 2 Study to establish the safety and efficacy of a drug called Ivacaftor~     (VX-770) in patients with chronic obstructive pulmonary disease (COPD), chronic bronchitis,~     and acquired CFTR dysfunction as detected by sweat chloride analysis. The design is a pilot,~     randomized (3:1, active:placebo), double-blind, placebo-controlled study. Approximately 40~     subjects with COPD will be randomized.~   "
42107|NCT03015571|"~     The aim of the study is to determine whether Narrow Band Imaging(NBI) should be routinely~     used during esophagus inspection at diagnostic gastroscopy.~   "
36759|NCT03085459|"~     A retrospective, observational study was performed about the patients with septic shock who~     admitted into intensive care unit (ICU) from January 1, 2015 to February 29, 2016. The number~     of patients who received empiric antibiotic treatment within first hour after septic shock~     diagnosis were collected. Detailed information about clinical ladder for nursing stuff and~     nursing shift were collected . Clinical ladder for nursing stuff is a new definition based on~     education background and work experience and nurses stuff are classified into four levels. N0~     was defined who got college degree or above, nurse qualification certificate and working time~     less than one year. N1 an N2 were defined as who got nurse qualification certificate and~     working time between 1~3 years and more than three years, respectively. N3 was defined who~     was nurse-in-charge qualification or got nurse practitioner qualification for more than five~     years. Compliance of empiric antibiotic treatment within first hour and evaluate the effect~     of nursing stuff on the compliance were calculated.~   "
36760|NCT03085446|"~     Insomnia is a chronic mental health condition characterized by difficulty initiating and~     maintaining sleep with a prevalence of over 50% in Israeli adults ages 65 and above. It is~     associated with increased risks for chronic illnesses (e.g., cardiovascular disease), poor~     mental health (e.g., anxiety and depression), functional limitations, and cognitive decline.~     Available pharmacological and behavioral treatments focusing on reducing nighttime~     hyper-arousal offer limited success, and it appears that there is no one size fits all~     treatment for late life insomnia. Mounting evidence suggests that sleep is related to~     metabolic status, however, studies on the associations between sleep and dietary patterns are~     surprisingly scarce.~      The ability of gut microbiota to communicate with the brain is emerging as an exciting~     concept in health and disease and provides the rationale for the present project. Findings~     demonstrate that gut microbiota modulates mental capacities such as brain plasticity and~     cognitive functions in older adults, as well as stress related mental illness. The~     composition of the intestinal microbiota in older people (>65 years) differs from the core~     microbiota and diversity levels of younger adults. With age, gut populations of beneficial~     microbes show a marked decline. As diet has been shown to markedly promote microbiota~     biodiversity, it is hypothesized that diet-induced changes in microbiota may provide a novel~     approach for the treatment of mental health. Although insomnia is strongly linked to mental~     health (e.g., depression and anxiety), as well as cognitive and motor performance, the~     effects of diet-induced microbiota alterations, based on individual microbiota composition,~     on late life insomnia is currently unknown.~      The proposed project will be the first to investigate the associations between gut microbiota~     and sleep, and assess the potential of a six-months personalized, diet-induced microbiota~     alterations intervention (PDM), aimed to improve insomnia in older adults. We will also look~     at cognitive, motor and mental health factors as possible mediators in this relationship.~     Specifically, we will test the associations between microbiota composition and sleep quality,~     both cross-sectionally and longitudinally, i.e., following a PDM intervention; evaluate the~     impact of PDM on changes in cognitive, motor and mental health functions; and identify the~     mediating roles of changes in cognitive, motor and mental functioning on the effects of a PDM~     intervention on sleep quality. Findings are expected to improve the quality of life of older~     adults by enhancing their sleep, functional status, mental health and overall wellbeing.~   "
36761|NCT03085433|"~     This is a randomized controlled trial of couples with a history of poor embryo quality~     undergoing a repeat in vitro fertilization (IVF) cycle for unexplained infertility. Couples~     will be randomized to sperm selection by the clinical standard of centrifugation and~     density-gradient processing compared to the microfluidic sperm sorting chip.~   "
36762|NCT03085420|"~     The purpose of this study is to collect information about how often an abnormal heart beat~     happens in children who have been burned.~   "
36763|NCT03085407|"~     In patients with mild gallstone pancreatitis, early cholecystectomy within 48 hours might~     reduce the risk of recurrent gallstone-related complications, compared with the more commonly~     used strategy in our locality of conservative management and delayed cholecystectomy.~     However, evidence to support early cholecystectomy is poor, and concerns exist about an~     increased risk of cholecystectomy-related complications with this approach. In this study, we~     aimed to compare the benefits and harms of early versus delayed cholecystectomy in patients~     with mild biliary pancreatitis.~   "
36764|NCT03085394|"~     Prophylactic use of tranexamic acid to reduce intra and postoperative bleeding in primary~     sleeve gastrectomy procedures will be studied.~   "
36765|NCT03085381|"~     To evaluate the safety and primary immunogenicity of the quadrivalent human papillomavirus~     (types 6, 11, 16, 18) recombinant vaccine (hansenula polymorpha) in Chinese female subjects~     aged 9-45 years.~   "
36766|NCT03085368|"~     This is a randomized controlled trial of HER-2 positive breast cancer patients treated with~     lapatinib and paclitaxel vs herceptin and paclitaxel with sequential and synchronous~     anthracycline~   "
36767|NCT03085355|"~     The purpose of this randomized pragmatic clinical trial is to assess the effectiveness of the~     association of the osteopathic manipulative treatment in individuals with chronic~     non-specific neck pain who receive a exercice program and pain neurocience education.~   "
36768|NCT03085342|"~     As cirrhosis progresses, alteration of hemodynamics develops and decreased portal flow is~     often observed. Since direct measurement of portal pressure (HVPG) is invasive, non-invasive~     methods have drawn a lot of attention. MRI is one of the non-invasive methods and it is able~     to provide multiparametric data in one examination. Herein, we evaluate hepatic fibrosis with~     different stage using multiparametric MRI with emphasis on portal flow measurement.~   "
36769|NCT03085329|"~     This study is designed to test the hypothesis that among infants born at less than 30 weeks,~     weighing less than 1500 g at delivery, and receiving initial respiratory support~     non-invasively or on invasive respiratory support and meeting extubation criteria in the~     first 72 h of life, fewer neonates managed on Seattle--PAP will require endotracheal~     intubation and conventional mechanical ventilation (CMV) than will neonates managed from~     birth on bubble nasal continuous positive airway pressure (Bn-CPAP) using the Fischer- &~     Paykel (FP) device. Neonates on nasal continuous positive airway pressure (CPAP) in the~     delivery room or who are stabilized on mechanical ventilation as their initial form of~     respiratory support and meet our criteria for extubation within 72 h of birth will be~     eligible for randomization and study.~      The primary endpoint of this study is the cumulative incidence of respiratory failure~     requiring intubation that occurs in patients after randomization and before 36 weeks post~     menstrual age (PMA) or discharge, whichever comes first. Presently, the literature supports~     that this age group typically exhibits intubation rates of 50% or more, which is consistent~     with the data from the Nationwide Children's Hospital/Ohio State University (NCH/OSU)~     Neonatal Intensive Care Unit (NICU).~   "
36770|NCT03085316|"~     Standard treatment options for patients who are diagnosed with BVFP include tracheostomy,~     cordotomy, arytenoidectomy, and suture tie-back. These standard treatment options may result~     in permanent damage to the vocal fold, therefore affecting the patient's ability to speak and~     compromising airway protection during swallowing. Additionally, these routine procedures~     cannot provide sufficient airway to permit significant aerobic activity. The goal in~     conducting this early feasibility study is to investigate the use of this device as a~     laryngeal pacemaker to treat BVFP.~   "
36772|NCT03085290|"~     Serum eye drops (SEDs) are used to treat patients with extreme dry eyes and other corneal~     defects. Serum is used in severe ophthalmic cases where conventional eye drops (artificial~     tears) have insufficient effect. The use of SEDs in dry eye patients usually has a rapid~     effect. Most patients claim the effect to be instantaneous, and all symptoms improve within~     48 hours.~      There is evidence suggesting that substances in serum may help in the healing of epithelial~     defects, such as epidermal growth factor, fibroblast growth factor, fibronectin, and/or~     vitamin A. However, the precise serum factor responsible for alleviating the patient's~     complaints is currently not known. Commonly, autologous SEDs are used, but they are replaced~     more and more by allogeneic SEDs prepared from donor serum.~      Allogeneic SED are derived from healthy voluntary, non-remunerated male donors with blood~     group AB. The use of allogeneic SED could provide blood bank controlled quality, a safer~     product in larger quantities that is quickly available for each patient.~      No double-blind randomized trials are known to exist to detect a difference in result between~     the effect of allogeneic SED or autologous SED. This pilot study is intended to obtain~     insight in the ability of autologous and allogeneic SEDs to improve patient dry eye~     sensation. Our hypothesis is that autologous SEDs (in a 1:1 dilution with saline) result in~     an improvement of the patient dry eye sensation, while allogeneic SEDs (in a 1:1 dilution~     with saline) do not.~   "
36773|NCT03085277|"~     Feeding intolerance is a common problem in very preterm infants due to their immature~     digestive system. This intolerance extends the time to full enteral feeding and thereby also~     prolongs the time on parenteral nutrition (PN). Prolonged time to full enteral feeding may~     predispose these infants to a higher risk of growth retardation, infections and organ~     dysfunctions (e.g. liver, brain). Mother's own milk (MM) is considered the optimal nutrition~     for preterm infants and is superior to infant formula (including preterm formula, PF) in~     stimulating gut maturation, feeding tolerance, resistance against necrotizing enterocolitis~     (NEC) and late-onset sepsis (LOS), and long-term neurodevelopmental outcomes. However, MM is~     often absent, or not available in sufficient amounts, during the first days or weeks after~     preterm delivery. Human donor milk (DM) is probably a better supplement to MM than PF, but DM~     is not available for all hospitals. To supplement insufficient MM during the early neonatal~     period in hospital settings with no access to donor milk, we suggest that bovine colostrum~     (BC) may be used instead of PF for very preterm infants during early life. BC, the first milk~     from cows after birth, is a rich source of protein and bioactive components, including~     lactoferrin, lysozyme, lactoperoxidase, immunoglobulins, and various growth factors, such as~     IGF-I and -II, EGFs, and TGF-β. BC has repeatedly been shown to improve gut maturation and~     NEC/LOS resistance in a well-established piglet model of preterm infants. We suggest a~     randomized, controlled trial to investigate the effects of BC vs. PF, supplemented to MM~     during the first 2 weeks, on the time to full enteral feeding in very preterm infants.~   "
36774|NCT03085264|"~     This study focuses on pairing community health workers (CHWs) with patients that are high~     risk for readmission prior to hospital discharge in order to assess differences in hospital~     readmission rates, ED visits, patient satisfaction and provider satisfaction as compared to~     patients without community health worker pairings at discharge.~   "
36775|NCT03085251|"~     The objective of this study is the evaluation of system accuracy based on EN ISO 15197:2015~     (ISO 15197:2013), clause 6.3 in which accuracy requirements and applicable test procedures~     for blood glucose monitoring systems intended for self-monitoring of blood glucose by~     patients are stipulated. ISO 15197:20132 was harmonized with the regulations of the European~     Union as EN ISO 15197:2015. This harmonization had no impact on the requirements and~     procedu¬res in ISO 15197:2013; changes were made to the foreword and an informative annex. In~     this study, system accuracy evaluation will be performed for OneTouch® Verio Flex (LifeScan~     Europe) on behalf of LifeScan Scotland Limited (customer) with three different reagent system~     lots.~   "
36776|NCT03085238|"~     M-Trap is an implantable medical device designed to capture disseminated tumor cells (DTCs).~     It is intended for use in advanced-stage ovarian cancer patients. The study objective is to~     assess the safety and the performance of the M-Trap device.~   "
36777|NCT03085225|"~     A phase Ib trial study of trabectedin when prescribed in combination with durvalumab in~     locally advanced/unresectable soft-tissue sarcoma and ovarian carcinomas.~   "
36778|NCT03085212|"~     The purpose of pilot study application is to build on the investigators' previous work that~     established the prospective association between stress and infertility. Specifically, the~     investigators hope to collect the preliminary data necessary to make them competitive to~     submit a R01 application to NIH for funding of a full-scale randomized controlled trial of an~     internet-based stress management program to examine its efficacy in decreasing stress and~     increasing pregnancy rates among women who have tried to get pregnant for 6-12 months without~     success. The program called Stress Free Now (SFN) was developed at the Cleveland Clinic and~     has been shown to be effective in lowering stress in a variety of populations. The program~     introduces concepts of mindfulness and cognitive-behavioral therapy to assist individuals in~     managing their stress levels. The intervention includes Internet-based interaction, daily~     emails and recommended relaxation practice of at least four days per week. Using targeted~     Facebook Ads and other recruitment modalities, the investigators will randomize 40 women ages~     18-34 who have been trying to conceive for 6-12 months without success. The PI has been~     enrolling women in a similar study using this mechanism and has found it to be an efficient~     and cost-effective method of identifying potentially eligible individuals. Women will be~     randomized to SFN or a wait list control condition and will be followed for up to three~     months post-randomization with weekly journals as they try to conceive. The primary outcome~     of this randomized controlled trial is stress level, as measured by salivary alpha-amylase,~     while the secondary outcome will be pregnancy rate at the end of the three-month follow-up~     period.~   "
36779|NCT03085199|"~     Until now, no prospective clinical trial for duodenal stump leakage after laparoscopic or~     open gastrectomy for gastric cancer patients has been conducted.~      We already introduced a technique of laparoscopic reinforcement suture (LARS) on staple-line~     of duodenal stump using barbed suture for prevention of duodenal stump leakage. Therefore, a~     prospective phase II study was designed for safety of this technique.~   "
42134|NCT03015220|"~     This trial is conducted in Asia. The aim of this trial is to investigate Safety and efficacy~     of oral semaglutide versus dulaglutide both in combination with one OAD (oral antidiabetic~     drug) in Japanese subjects with type 2 diabetes.~   "
36780|NCT03085186|"~     Two year old male with a new diagnosis of Inflammatory Myofibroblastic Tumour. The patient~     presented with 2 months of intermittent fever and 1-2 weeks of abdominal distention and~     constipation. An abdominal mass was palpable on exam and US concerning was for neoplasm of~     abdomen.~      Treatment with Crizotinib will be utilized to reduce the size of the lesion and create more~     optimal tissue plains between vital structures prior to attempted surgical resection would~     greatly reduce potential morbidity for this patient.~   "
36781|NCT03085173|"~     The purpose of this phase I study is to test the safety of different dose levels of specially~     prepared cells collected from the patient called modified T cells. The investigators want~     to find a safe dose of modified T cells for patients with this type of cancer that has~     progressed after standard therapy. The investigators also want to find out what effects these~     modified T cells have on the patient and the cancer.~   "
36782|NCT03085160|"~     Research suggests there is a connection between mood and weight. People who feel stressed or~     depressed are more likely to be overweight than people who don't have these feelings. Some~     individuals turn to food to cope, which can lead to gaining too much weight over time.~     Adolescence is an important time to understand these connections. Patterns of handling stress~     learned during adolescence set the stage for stress management in adulthood. This study is a~     randomized controlled pilot study with 60 adolescents who are at-risk for future, chronic~     obesity. The investigators will test if taking part in a 6-week group program to lower stress~     and improve mood will be helpful to teens at-risk.~   "
36783|NCT03085147|"~     The purpose of this study is to test if an investigational dye, called PARPi-FL, can be used~     to detect this type of cancer. This will be the first time that PARPi-FL is being tried in~     people. First, the investigators will test the safety of PARPi-FL at different doses to find~     out what effects, if any, it has on people. The investigators will also see which amount of~     PARPi-FL is best suited to detect cancers of the mouth and tongue.~   "
36784|NCT03085134|"~     The primary objective of the study is to show that infants with cow milk protein allergy~     (CMPA) fed with a new FSMP infant formula with reduced level of protein & with 2 Human Milk~     Oligosaccharides (HMOs) (test formula) have a growth in line with infants fed with a~     comparable FSMP formula but without HMOs (control formula). The secondary objectives are to~     assess whether consumption of Test formula by CMPA infants (i) reduces medication use and~     risk for infections in particular lower respiratory tract infections/morbidity, (ii) is well~     tolerated and allows for age appropriate growth and (iii) reduces health care costs.~   "
36785|NCT03085121|"~     A prospective study will be performed to compare the clinical outcome after total knee~     arthroplasty (TKA) using two different alignment systems: an extramedullary system versus an~     intramedullary system. The extramedullary femoral alignment system is newly designed. These~     two systems are used to make the distal femoral resection in 100 patients in a random order.~   "
36786|NCT03085108|"~     The main purpose of this cross-sectional study is to generate data to support the~     psychometric properties of the Suicide Ideation and Behavior Assessment Tool (SIBAT) and~     validate its use in participants at imminent risk of suicide.~   "
36787|NCT03085095|"~     The purpose of this study is to determine the benefit and safety of relugolix 120 mg orally~     once daily for 48 weeks on maintaining serum testosterone suppression to castrate levels~     (<=50 ng/dL [1.7 nmol/L] in patients with androgen-sensitive advanced prostate cancer.~   "
36788|NCT03085082|"~     the study is searching if there is a relationship between the blood groups and RH and the~     skeletal malocclusion using the skeletal class I as a control group~   "
36789|NCT03085069|"~     This is an open-label, single-arm, multi-center, phase 2 Study to evaluate SHR-1210(anti-PD-1~     antibody) as second-line therapy in in adult Chinese patients with advanced or metastatic~     non-small cell lung cancer who failed or progressed to prior first-line systemic treatment.~      Enrolled subjects will be assigned to 4 cohorts on the basis of PD-L1 expression in tumor~     cells(<1%, ≥1%-25%, ≥25%-50%, ≥50%) all will be treated with the standard SHR-1210 dose~     (200mg) , Q2W, until documented progressive disease (PD) occurs. Subjects will return to the~     clinic once every two weeks. Radiographic disease assessments will be performed every 6~     weeks.~      The primary study hypothesis is that treatment with SHR-1210 improves Objective Response Rate~     when compare with standard of care (SOC), no matter how much PD-L1 expression in tumor.~   "
36790|NCT03085056|"~     The purpose of this study is to test the safety and tolerability of this treatment~     combination of paclitaxel and trametinib. Additionally, this study aims to to find out what~     effects the combination of paclitaxel and trametinib has on the shrinkage and growth of~     anaplastic thyroid cancer.~   "
36791|NCT03085043|"~     The goal of this clinical research study is to compare 2 different types of magnetic~     resonance imaging (MRI). Researchers will compare diffusion-weighted imaging (a method to~     show how water moves in a certain area) with standard-of-care imaging to learn which method~     is better to check the status of prostate cancer.~      This is an investigational study. The whole-body MRI scan in this study is performed using an~     FDA-approved and commercially available method. Having whole- body MRI with your~     standard-of-care MRI of the pelvis at the same time is investigational.~      Up to 86 participants will be enrolled in this study. All will take part at MD Anderson.~   "
36792|NCT03085030|"~     The aim of the study is to evaluate the effect of antioxidants on IVF outcome in infertile~     patients undergoing IVF who are expected to produce low number of eggs compared to a control~     group. The investigators assumed that the conception rate is higher in those patients taking~     some antioxidants supplementation. The patients will be given antioxidant drug one month~     before starting IVF trial once daily by mouth. Uniform protocol of stimulation will be done~     during the cycle by a type of short protocols known as the antagonist protocol. Egg retrieval~     will be done under anesthesia. pregnancy test will be done 2 weeks after embryo transfer. The~     investigators will also assess the number and quality of eggs on the day of egg pick up. In~     addition, the researchers will assess the number of first and second grade embryos that are~     put on the day of embryo transfer.~   "
36793|NCT03085017|"~     A prospective randomized open-label study that will evaluate the effectiveness of the pliable~     and absorbable bone hemostats (BoneSeal®) on the reduction of bleeding from the sternal bone~     marrow in patients undergoing cardiothoracic surgery.~   "
36794|NCT03085004|"~     The purpose of this study is to evaluate the efficacy of chemotherapeutic pancreatic cyst~     ablation using ethanol lavage followed by the infusion of a single agent chemotherapeutic~     agent (paclitaxel) compared with alcohol free, saline lavage followed by infusion of a~     multi-agent chemotherapeutic cocktail (paclitaxel + gemcitabine) for the ablation of~     pancreatic cystic neoplasms using endoscopic ultrasound fine needle infusion (EUS-FNI) for~     agent delivery. The ultimate purpose os a safe and more effective EUS-FNI , method to~     eliminate there pre cancerous cyst and prevent a significant percentage of pancreatic cancer.~   "
36795|NCT03084991|"~     The purpose of the study is to investigate the clinical outcomes, safety and~     cost-effectiveness of intravascular OCT imaging in patients with STEMI undergoing primary~     PCI.The study will enrolled about 4500 STEMI patients(1500 with OCT and 3000 without OCT~     during primary PCI）in 20 sites of China. The total duration of the study is expected to be 5~     years, 2 years for enrolment and 3 years for total follow up.~   "
36796|NCT03084978|"~     This is a randomized controlled trial investigating the effect of general anesthesia versus~     conscious sedation on operative times in patients undergoing transcatheter aortic valve~     replacement.~   "
36797|NCT03084965|"~     Retrospective Study of Patients With Type 2 Diabetes Mellitus on Dapagliflozin Therapy in~     Taiwan.~   "
36798|NCT03084952|"~     It is a randomized phase II clinical study, unicentre aimed to evaluate the tolerability,~     safety and efficacy of 18-Methoxyoronaridine as a candidate of tegumentary leishmaniasis~     treatment.~   "
36799|NCT03084939|"~     This is a Phase III, randomized, multicenter, two-arm, open-label study designed to evaluate~     the safety and efficacy of trastuzumab emtansine compared with that of lapatinib +~     capecitabine in Chinese participants with HER2-positive, unresectable locally advanced breast~     cancer (LABC) or metastatic breast cancer (MBC) who have received prior trastuzumab-based~     therapy. A total of approximately 350 participants will be enrolled in China. The study will~     consist of 2 stages. Stage 1: Eligible participants will be randomized in a 3:1 ratio to~     receive either trastuzumab emtansine or control (lapatinib + capecitabine). Stage 2: After~     Stage 1 is recruited, eligible patients will be enrolled to receive trastuzumab emtansine~     only.~   "
36800|NCT03084926|"~     This study is investigating a new experimental therapy, MP0274, a DARPin® drug candidate~     targeting HER2. Preclinical studies suggest that MP0274 may provide additional benefit for~     the treatment of HER2-positive cancers. This is the first study of MP0274 in humans and its~     main purpose is to test its safety and tolerability in patients with HER2-positive cancer.~     This study will also examine the blood levels of MP0274 at several escalating dose levels and~     a recommended dose for further development will be determined. The recommended dose will be~     tested in a second part of the study to confirm safety and to further assess the preliminary~     biologic and anti-tumor activity~   "
36801|NCT03084913|"~     This study compared a plant-based, olive oil diet to the diet recommended by the Prostate~     Cancer Foundation for weight loss and improvement in some laboratory biomarkers.~   "
36802|NCT03084900|"~     Investigators propose to study an intervention that will provide patient-centered, automated~     decision support to diabetes providers with the goals of improving adherence to medical~     recommendations (both patients and providers), improving self-management, and ultimately~     improving health outcomes.~   "
36803|NCT03084887|"~     Reduce the common complications incidence about patients placed tissue expansion devices to~     around 5%.~   "
36804|NCT03084874|"~     Patients with COPD are more inactive and more sedentary than subjects of the same age and~     patients with other chronic diseases. This inactivity and sedentary behavior is accentuated~     after hospitalizations due to a COPD exacerbation, and it increases the risk for future~     hospitalizations and mortality. Therefore, there is a need for intervention to promote~     physical activity and to reduce sedentary behavior after these events. The present study aims~     to evaluate the efficacy of a coaching program to promote physical activity and reduce~     sedentary behavior in patients with COPD who have suffered a hospitalization due to a COPD~     exacerbation. Sixty-six COPD patients admitted to the hospital will be recruited during 18~     months. Physical activity, sedentary behaviors, as well as other clinical and functional~     parameters will be evaluated after hospital discharge. Patients will be then randomized to an~     intervention and control group (1:1). The intervention group will receive an individualized~     coaching program. During a motivational interview an experienced physiotherapist will asses~     participant's usual exercise habits, possible barriers and facilitators, self-efficacy and~     motivation to increase physical activity and reduce sedentary time. Based on these data (and~     baseline physical activity/sedentary information) an individualized, progressive program with~     specific goals setting and self-monitoring will be established (patients will be active~     participants and decision makers in this process). The control group will receive the usual~     care during follow-up. Physical activity, sedentary behaviors, as well as the clinical and~     functional variables will be evaluated again at 12 weeks in both patients' groups.~   "
36805|NCT03084861|"~     This is a multicenter, randomized, open-label, two-arms phase I/II, clinical trial, in which~     42 patients will be enrolled with the principal objective to evaluate the efficacy through~     changes in lesion size and, secondary, to evaluate the safety and efficacy through corneal~     sensibility, corneal opacity, visual acuity and complications of Neurotrophic Keratopathy~     (NK). Patients will be randomized 1:1 to receive experimental treatment (cord blood eye~     drops) or conventional treatment (artificial tears and therapeutic contact lens).~   "
36806|NCT03084848|"~     The purpose of this study is to investigate the cognitive and brain effects of inhibitory~     control (IC) training at adolescence.~   "
36807|NCT03084835|"~     This study will evaluate the impact of a proactive, EHR-supported enrollment strategy that~     links LDCT-eligible smokers with an evidence-based intervention comprised of a web-based~     program and integrated text messaging. The goal is to provide actionable findings about how~     to most effectively and cost efficiently promote abstinence in LDCT clinics.~   "
36821|NCT03084653|"~     Several techniques for initial abdominal entry in laparoscopy have been introduced in~     literature. Various guidelines and recommendations are available on this subject, however,~     compliance to these are controversial. The purpose of this study is to evaluate the rationale~     and the process of decision making for first entry technique in laparoscopy.~   "
36808|NCT03084822|"~     Given the importance of healthy lifestyle practices to cardiovascular disease (CVD)~     prevention and the utility of church-based interventions in African-American adults, the~     investigators developed a theory-informed, strategically-planned, health and wellness~     intervention with Rochester, Minnesota (MN) and Twin Cities area (Minneapolis, St. Paul, MN)~     churches with predominately African-American congregations. The objective of the study was to~     partner with churches to implement a multi-component, health education program through the~     use of core educational sessions delivered through a digital-application accessible on demand~     via interactive access on computer tablets and the Internet. The overarching goal was to~     increase the awareness and critical importance of healthy lifestyles for CVD prevention and~     provide support for behavior change.~   "
36809|NCT03084809|"~     Cytokine-induced killer cells (CIK) is an auxiliary antitumor treatment. The investigators~     aim to evaluate the clinical efficacy of chemotherapy combined with CIK in the treatment of~     postoperative colorectal cancer patients. And to provide useful reference for the clinical~     application of CIK in colorectal cancer patients.~   "
36810|NCT03084796|"~     The purpose of this study is to evaluate the dose-response of different doses of CHF 5259~     pMDI on lung function and other clinical outcomes, to identify the optimal dose(s) in terms~     of benefit/ risk ratio for further development in the target subject population.~   "
36811|NCT03084783|"~     Encephalitics is a serious condition in which the brain becomes inflamed (swollen). It~     usually happens as a direct result of virus, such as herpes simplex virus (HSV).~      HSV encephalitis is often treated with the drug acyclovir (an antiviral drug which slows the~     growth and spread of HSV in the body). Despite this however, around 2 out of every 3 people~     will have memory difficulties long term. Dexamethasone is a corticosteroid medication, which~     works by preventing the release of natural chemicals in the body which cause inflammation. It~     is possible that dexamethasone could help to reduce in swelling of the brain may improve the~     recovery of patients with HSV encephalitis. The aim of this study is to find out whether~     treatment with dexamethasone can improve long-term health outcomes in adults with HSV~     Encephalitis.~   "
36812|NCT03084770|"~     The aim of the study is to evaluate the most appropriate management of sporadic asymptomatic~     non-functioning pancreatic neuroendocrine neoplasms (NF-PNEN) ≤ 2 cm. P NF-PNEN management~     will be decided at the hospital and all therapeutics decision will be decided/coordinated by~     the treating physician.~      Patients will be either submitted to surgical resection or to active surveillance.~   "
36813|NCT03084757|"~     The study will evaluate the efficacy of targeted therapy based on tumor molecular profiling~     versus conventional chemotherapy in patients with advanced cancer using each patient as its~     own control. This study is a study involving patients with advanced cancer. All types of~     solid tumors will be allowed in the study.~   "
36814|NCT03084744|"~     To compare the efficacy of schema therapy versus active monitoring for women with chronic~     depression receiving psychiatric care.~   "
36815|NCT03084731|"~     Burden: According to Bangladesh Demographic Health Survey 2014, prevalence of stunting in~     under-five children is 36%. Severe acute malnutrition (SAM) is prevalent in about 3% of them.~     In absolute numbers, about 450,000 children suffer from SAM while several million children~     suffer from moderate acute malnutrition (MAM).~      Knowledge gap: Investigators have already demonstrated that children with SAM have immature~     gut microbiota that is partially corrected with treatment. Through our earlier studies~     conducted in Bangladesh,investigators now also have idea about beneficial microbiota and food~     ingredients that support proliferation of these beneficial microbiota. Which composite food~     is better for children with SAM and MAM is not known.~      Hypothesis (if any): The central hypothesis of our ongoing Breast Milk, Gut Microbiome and~     Immunity (BMMI) initiative proof of concept phase is that healthy growth in infancy and early~     childhood requires normal functional maturation of the gut microbiota. Related hypotheses are~     that (i) persistent defects in the development of this microbial 'organ' are causally related~     to stunting as well as the metabolic, immunologic and cognitive manifestations of~     undernutrition; and (ii) new approaches for durable repair of this microbiota immaturity~     including Microbiota-Directed Complementary Foods (MDCF) will provide a way to improve~     clinical outcomes.~      Objectives:~        1. Test 5 MDCF prototypes and nominate a lead MDCF formulation that has the greatest effect~          in promoting the representation of a broad range of age-discriminatory taxa and that has~          acceptable organoleptic properties. This nominated lead will be advanced to a fully~          powered clinical POC study in children with post-SAM MAM in 2018.~        2. Determine whether once daily administration is as effective as twice daily~          administration of the lead MDCF in repairing microbiota immaturity.~        3. Assess the durability of repair of immaturity by the lead MDCF by including a 4 week~          post-intervention phase in the final pre-POC study design.~        4. Determine what effect enteropathogen burden (determined by PCR-based analysis of fecal~          samples) has on responses of age-discriminatory taxa to MDCFs, and reciprocally, the~          effect of MDCFs on enteropathogen burden.~      Methods:~      Investigators will conduct 3 Pre-POC studies in 12-18 month old children with MAM~     (Weight-for-Length Z-score, WLZ: between <-2 to -3) and stunting (Length-for-Age Z-score,~     LAZ: between <-2 to -3) over the course of approximately two years. The investigators will~     use a stratified randomization procedure based on age (i.e.2 levels: 12-15 months and >15-18~     months) to prevent imbalance between the treatment arms. This study will be undertaken at~     Mirpur area of Dhaka city. The investigators will design and produce 5 MDCF prototypes at the~     icddr,b Food Processing Laboratory in sufficient quantities for clinical studies (3 MDCF~     prototypes for study 1 and 2 MDCF prototypes for study 2). These formulations will be matched~     in energy density and micronutrient content of ready-to-use supplementary foods (RUSFs) used~     for MAM in Bangladesh and other countries, and will meet all other requirements for a~     complementary/supplementary food for 12-18 month old children with MAM and stunting.~   "
36816|NCT03084718|"~     The purpose of this study is to evaluate the dose-response of different doses of CHF 781 pMDI~     on lung function and other clinical outcomes, to identify the optimal dose(s) in terms of~     benefit/ risk ratio for further development in the target patient population.~   "
36817|NCT03084705|"~     The goal of this study is to determine the effectiveness of interactive feedback from a~     wearable device that senses hand function, the Manumeter, in improving upper extremity~     function in a pilot, randomized controlled trial with chronic stroke patients~   "
36818|NCT03084692|"~     The purpose of the study is to determine the feasibility and preliminary efficacy of a~     combined therapeutic yoga and resistance exercise intervention for individuals with lung~     cancer and their caregivers. The investigators aim is to help reduce the fear of exercise by~     tailoring the program to meet the specific needs of the survivor with lung cancer. The~     investigators want to see whether individuals with lung cancer and their caregivers are~     interested in participating in this type of program, and if they are able to attend the~     intervention sessions and complete the program. The investigators also plan to study the~     preliminary effects of therapeutic yoga and resistance exercise on fitness outcomes for both~     individuals with lung cancer and their caregivers.~   "
36819|NCT03084679|"~     The investigators hypothesised that novel MRI metrics derived from myocardium post-gadolinium~     T1 mapping analysis will improve the current knowledge about the role interstitial fibrosis~     and cardiomyocyte hypertrophy in the development of left ventricular (LV) remodelling and~     clinical Heart Failure (HF). The investigators believe that these recently described~     variables will be associated with prognostically important indices in HF development.~   "
36820|NCT03084666|"~     In this study, patients undergoing live donor kidney transplantation will be allocated to the~     control group or remote ischemic preconditioning group (RIPC). RIPC is the utilization of~     short periods of ischemia to provide protection of the myocardium or other organ (i.e.~     kidney) from a subsequent ischemic event. Before allograft implantation, RIPC will be~     accomplished in the recipient and donor by inducing intermittent extremity ischemia through~     intermittent inflation of an extremity tourniquet three times for five-minute intervals with~     five minutes of deflation between inflation periods. The monitored clinical end points will~     include total urine output following kidney reperfusion over five days, plasma creatinine~     declination over five days, initiation of dialysis, and development of graft injury.~     Magnitude of graft injury is the primary endpoint and will be measured using biochemical~     markers, such as, plasma and urinary concentration of neutrophil gelatinase associated~     lipocalin (NGAL), IL-18, and KIM-1. The sample size calculation is based on a projected~     difference of NGAL levels between the two study arms. Hall et al reported a mean NGAL level~     of 49 mg/mL (SD = 37 mg/mL) for a group of patients that had immediate graph function and a~     mean NGAL level of 248 mg/mL in a group of patients with slow graft function. (which Hall~     reference is this) Based on these data, a conservative estimate of a mean difference between~     study groups will be considered 35 mg/mL NGAL. Using these assumptions, an alpha level of~     0.05 and 80% power, a sample size of n= 19 per study group will be calculated. By rejecting~     our null hypothesis, RIPC may serve as a safe, cost-effective protective strategy to prevent~     allograft injury in the clinical setting of live donor kidney transplantation.~   "
42135|NCT03015207|"~     This trial is conducted in The United States of America. The aim of this trial is to~     investigate Safety, Tolerability and Pharmacokinetics (the exposure of the trial drug in the~     body) of NNC0194-0499 in Male Subjects with Overweight or Obesity.~   "
36822|NCT03084640|"~     CMP-001-002 is a Phase 1b study of CMP-001 administered to subjects with advanced cutaneous~     melanoma who are either receiving Pembrolizumab, or who have previously received an~     anti-PD-1/PD-L1 therapy for advanced cutaneous melanoma, and who have not responded (i.e.~     immunotherapy resistant) after at least 4 administrations of anti-PD1/PD-L1 therapy.~      This study will be conducted in two parts:~      Part 1 will consist of a Dose Escalation Phase and a Dose Expansion Phase of CMP-001~        -  Dose Escalation Phase will be conducted to assess and identify a recommended phase 2~          dose (RP2D)~        -  The Dose Expansion Phase is intended to further characterize the safety,~          pharmacodynamics, and preliminary evidence of antitumor activity of the RP2D of CMP-001~          administered SC and IT in combination with Pembrolizumab~      Part 2 will assess the safety and preliminary evidence of antitumor activity of CMP-001,~     administered SC for 2 weekly doses (Prime Phase; W1D1 & W2D1), IT for 4 weekly doses (Prime~     Phase; W3D1, W4D1, W5D1, & W6D1) and SC every 3 weeks thereafter (Boost Phase; W9D1, W12D1,~     etc.) when given in combination with Pembrolizumab~   "
36823|NCT03084627|"~     Pregnancy is associated with an increase in nutrient requirements. During this period, women~     would be keener on adopting healthier behaviors. Thus, pregnancy represents an opportunity to~     improve the nutrient adequacy of the diet of mothers-to-be. This study is a randomized~     controlled trial, which aims at evaluating the efficiency of a tailored dietary advice tool~     in improving the nutrient adequacy of the diet of pregnant women, as measured by the PANDiet.~     Eighty pregnant women will be included in the study and randomized either in the control~     group, or in the intervention group. The control group will receive generic dietary advice~     based on a booklet edited by the French Institute for Health Promotion and Health Education~     (INPES). The intervention group will receive the same generic dietary advice plus tailored~     dietary advice to improve the nutrient adequacy of their observed diets. Dietary intakes will~     be evaluated online using a 3 days food record, at baseline and 6 weeks after patients~     received the booklet and/or the first tailored dietary advice. Thus, the nutrient adequacy of~     the diet could be evaluated before and after the intervention in both groups.~      The dietary follow-up for one patient will last 12 weeks only, but data will be collected at~     delivery.~      Moreover, after, the 12-week dietary follow-up and before their deliveries, 10 participants~     (5 by group) will be contacted to participate in a qualitative interview. This interview will~     aim at understanding barriers and motivators to implement dietary advice (generic and/or~     tailored) in the diet of pregnant women in the study.~   "
36824|NCT03084614|"~     Background:~      When a person is exposed to something that causes an infection, the body sends a type of cell~     called CD8 T cells to attack it. Those cells are also found in breast milk. Nursing mothers~     pass these cells to their child, which helps the child fight infections, too. Researchers~     want to learn more about how CD8 cells work to keep people healthy.~      Objective:~      To learn more about how the human body fights off infections.~      Eligibility:~      People age 18 years and older who either have an infection, are suspected to have an~     infection, or recently got a vaccine.~      The household contacts of these people and people who have not been recently exposed to any~     infection are also needed.~      Design:~      Participants will be screened with a medical and health history and physical exam. They may~     have blood tests.~      The first study visit can be the same day as screening. It can be up to 3 months later. For~     those visits, screening tests will be repeated.~      At the first visit, participants will have blood collected from an arm vein.~      Participants who are breastfeeding may provide a small sample of breast milk. They may~     collect it at home or bring a pumping device to NIH to collect it. NIH can also provide a~     breast pump.~      Participants may be contacted for up to 1 year after the first visit to give samples of blood~     and/or breast milk.~      Up to 4 additional visits, which will each take about 1 hour, may be scheduled.~      A personal physician or local lab can collect blood from participants and ship it to NIH.~     Breast milk cannot be shipped.~   "
36825|NCT03084601|"~     The aim of the current study is to compare a newly introduced material which is a combination~     of triple mix antibiotics paste and anti-hyperlipidemia drug simvastatin, the new material is~     named 3MIX-TATIN & will be compared to triple antibiotic paste for management of necrotic~     primary molars by using lesion sterilization and tissue repair LSTR technique.~   "
36826|NCT03084588|"~     Patients undergoing shoulder surgery may experience moderate-to-severe pain during the first~     2-3 days following the operative procedure. Two methods are used to control pain in the early~     postoperative period. First, an interscalene nerve block (ISB) can be placed prior to surgery~     to block the pain fibers that supply the shoulder. Although an ISB provides effective~     analgesia for several hours after surgery, the block is associated with the potential for~     transient or permanent nerve injury. Furthermore, the ISB can wear off suddenly, resulting in~     the abrupt onset of severe pain. A second method of pain control involves the use of opioids.~     Opioids can provide potent pain relief following surgical procedures. However, the agents~     that are commonly used by anesthesiologists and surgeons only produce pain relief for 2-4~     hours, which leads to fluctuations in the levels of pain control. Recent data suggest that~     the use of a long-acting opioid like methadone in the operating room, which provides~     analgesia for 24-36 hours, may improve pain control after surgery. The aim of this clinical~     trial is to compare postoperative pain scores and analgesic requirements in patients~     randomized to receive either an ISB or methadone at the start of shoulder arthroscopic~     surgery.~   "
36827|NCT03084575|"~     The control of perineal malignant pain is difficult and challenging for pain physicians.~     Different modalities have been tried to treat this complex pain syndrome including~     pharmacotherapy and interventional therapy.~      Neuroaxial phenol rhizolysis is simple and cheap option. However; for patients with pelvic or~     rectal neoplasms and intact bowel and bladder sphincteric functions, there are neurosurgical~     recomendations of selective sacral nerve roots rhizotomy blockade as an alternative to~     chemical saddle rhizotomy.~   "
36897|NCT03083665|"~     The purpose of the study is to evaluate the efficacy of brivaracetam (BRV) compared to~     placebo (PBO) as adjunctive treatment in Asian subjects (>=16 to 80 years of age) with~     partial seizures with or without secondary generalization despite current treatment with 1 or~     2 concomitant antiepileptic drugs (AEDs) and to assess the safety and tolerability of BRV in~     subjects >= 16 years to 80 years of age.~   "
42158|NCT03014908|"~     The aim of this study was to look for discriminating variation in the concentrations of~     small-molecule metabolites in the plasma of T1DM children compared with non-diabetic matched~     controls using proton nuclear magnetic resonance (1H-NMR)-based metabolomics.~   "
36828|NCT03084562|"~     Myocardial perfusion scintigraphy is to evaluate coronary perfusion as well as heart muscle~     function. This examination takes place in two stages, one imaging at rest and one after a~     cardiac stress caused. This stress can be triggered as a first-line stress test. A~     pharmacological stress is proposed when stress test is not possible or contraindicated,~     Several drugs have a marketing authorization in this indication (adenosine, dipyridamole,~     regadenoson, dobutamine).~      Among them, the regadenoson is the most recent molecule. Marketed in France since 2013, it~     would allow a reduction of undesirable effects compared to other agents, especially~     adenosine. It is simple and quick to use thanks to a single dose administration. However, its~     cost is nearly 30 times higher than dipyridamole. In the investigational center, dipyridamole~     is currently the first-line pharmacological stress agent, whereas regadenoson is reserved for~     a limited number of doses, the indication of which must be justified (asthmatic patient or~     with severe COPD). Few studies in the literature specifically compare these two~     pharmacological agents (examination time, cost, tolerance) and the opinion on the use of~     regadenoson in the service is limited.~   "
36829|NCT03084549|"~     Episiotomy is a common obstetric gesture (20 to 30% of deliveries by the low route). In~     postpartum, perineal pains associated with episiotomy are common, about 70% on D7 and~     persistent 13% at 5 months. Most studies of obstetrical analgesia have focussed on pain~     during labor or following a caesarean section. The perineal pain associated with the~     realization of an episiotomy has been much less studied and often undervalued.~      Local ropivacaine has shown its effectiveness in the reduction of postoperative pain in many~     indications (wall surgery, hemorrhoidectomy, infiltration of trocar scars during~     laparoscopy). This product has the advantage of being well tolerated, easy access and~     administration. Three recent studies compared the post-episiotomy analgesic efficacy of local~     ropivacaine versus lidocaine versus placebo and lidocaine versus no infiltration. Two of~     these studies showed statistically significant results. However, they focused on the results~     at 24 and 48 hours and did not evaluate the analgesic efficacy in the medium and long term.~   "
36830|NCT03084536|"~     In this double blinded randomized placebo-controlled trial, 160 subjects scheduled for breast~     surgery involving the axilla will be administered a multimodal pain regimen including~     acetaminophen, dexamethasone, celecoxib, and gabapentin. 80 subjects will also receive a~     Pectoral Nerve blocks I and II (PECS I and II block) preoperatively.~   "
36831|NCT03084523|"~     Cerebrovascular disease is a major source of neural injury and there is an urgent need for~     comprehensive evaluation of these patients. High-resolution MRI (HR-MRI) allows direct~     visualization of intracranial vessel wall pathology in the setting of acute ischemic stroke~     and intracranial aneurysm (intracranial aneurysm rupture.Vessel wall enhancement on HR-MRI~     results from inflammation and has considerable potential as a marker of future stroke risk or~     aneurysm rupture. We will use our HR-MRIvwMRI protocol and other techniques of measuring~     plaque and aneurysms vulnerability, including laboratory markers of abnormal inflammation and~     oxidization, which have been shown to correlate with vulnerable carotid atherosclerosis and~     intracranial aneurysms, but have not been studied in symptomatic ICAS or IA.The unmet need is~     a study validating HR-MRI reliability and the association of vessel-wall enhancement with~     both symptomatic and pro-inflammatory status in patients with cerebrovascular disease.~   "
36832|NCT03084510|"~     To evaluate the safety and effectiveness of the Lotus™ Valve System for transcatheter aortic~     valve replacement (TAVR) in symptomatic Chinese patients with calcific, severe native aortic~     stenosis who are considered at high risk for surgical valve replacement.~   "
36833|NCT03084497|"~     The aim of ths study is to know the effects of infant massage in the maturation of the baby~     with Down syndrome. Scale Psychomotor Development Early Childhood Brunet-Lézine-Revised will~     be used to measure the maturational development of the baby with Down syndrome .~     Investigators will analyze two groups of intervention, the experimental group, in which~     parents will participate and will apply the knowledge learned in the course of Infant Massage~     and control, which does not receive the Infant Massage course during the study. Babies in~     both groups will be evaluated twice, at the beginning of the intervention (pretest) and end~     it after five weeks (posttest). The study population consists of 32 babies with Down syndrome~     between 4 and 8 months old.~   "
36834|NCT03084484|"~     The importance of micronutrients has been extensively reviewed and it was concluded that for~     prevention and treatment of periodontitis daily nutrition should include sufficient~     antioxidants, vitamin D and calcium.~      Up to now there is limited research available investigating the effect of vitamin C~     supplementation on the periodontal condition. Supplementation of vitamins and micronutrients~     has however raised numerous questions on clinical efficacy. Recently, a significant increase~     of medical literature on the effect of nutraceutical dietary aliments on general health has~     been noted.~      the aim of the present study is twofold. The first objective is to investigate the effect of~     twice-daily kiwifruit consumption as sole treatment modality in untreated periodontitis,~     followed after two months by initial periodontal therapy supported by continued kiwifruit~     consumption. The second objective is to investigate the effect of twice daily kiwifruit~     consumption on periodontal and systemic parameters of these periodontitis patients 3 months~     after treatment.~   "
36835|NCT03084471|"~     To evaluate the safety, tolerability, and anti-tumor activity of the combination of~     durvalumab + tremelimumab or durvalumab alone in different solid tumors.~   "
36846|NCT03084328|"~     Vitamin D deficiency is very common in patients with fatty liver disease as evidenced by our~     observations in the Metabolic Liver Clinic and that reported by others. We also observed that~     patients with more severe fatty liver disease had lower Vitamin D concentrations. Others have~     shown that replacing Vitamin D in patients with cirrhosis is effective and even patients with~     Vitamin D replete status have lowering of Vitamin D over time if not supplemented.~      One of the measures of liver injury in NAFLD is the plasma concentration of ALT and we will~     use this to follow patients as is currently done as standard of care. All patients in the~     Metabolic Liver Clinic are being routinely screened for Vitamin D deficiency as standard of~     care and treatment is being started with oral supplementation, but there are not standardized~     protocols to determine success of therapy. We hypothesize that patients with NAFLD with low~     Vitamin D levels will respond appropriately to Vitamin D supplementation for 6 months.~   "
36847|NCT03084315|"~     To determine changes in biomarkers associated with the use of electronic cigarettes among~     African American menthol and nonmenthol smokers.~   "
36836|NCT03084458|"~     Medical device technology for use by patients is gaining popularity. Modern cardiac disease~     management seeks to integrate multiple device technologies and capabilities to optimize~     health outcomes. Fitbit, Inc. manufactures a line of wireless-enabled activity, wearable~     trackers that are used in conjunction with a mobile device. The Fitbit trackers use~     three-dimensional accelerometers to sense and record movement. This technology represents a~     new frontier for patients and their health care providers to understand and track physical~     activity in real time. The primary aim of the current project is to assess whether activity~     feedback using FitBit technology affects implantable cardioverter defibrillator (ICD) patient~     activity level as measured by the ICD accelerometer. The investigators will also examine the~     perceived added value of Fitbit technology to an ICD patient user experience.~      Approximately 50 participants will be recruited. Participants in the experimental group (n =~     25) will use the Fitbit device for 12 weeks. The experimental group will receive fitness~     goals (number of steps per day) to increase activity from a baseline value to a minimum of~     7000 steps per day by week 9 of the intervention. Both groups will receive weekly texts~     messages to encourage activity. Feedback about technology satisfaction, cardiac anxiety,~     cardiac self-care, and health care utilization will be elicited from patients at multiple~     time points. Additional information will be gained about patient decision-making as~     participants may elect to continue Fitbit use beyond the study period; this will allow for~     behavioral evidence of the perceived value of adding this technology.~   "
36837|NCT03084445|"~     Objectives and hypothesis The scale and diversity of chemicals in worldwide use today is~     vast. Many of these chemicals are released into the environment where they are found in air,~     water, soil, house dust, and in the food supply, resulting in exposure to humans.~     Characterizing the extent of exposure and the effects of exposure in vulnerable populations,~     such as pregnant women and children, is of the utmost importance as the chemical structure of~     many of these compounds resembles hormones such as estrogen, testosterone and thyroid~     hormone, affect neurodevelopment and other health effects. Here, we focus on few classes of~     compounds: heavy metals, volatile organic compounds (VOCs), brominated flame retardants~     (PBDEs) and phthalates. We will characterize the extent of exposure to pregnant women and~     their infants in Israel, where biomonitoring studies in the general population are scarce. We~     will also examine selected outcomes in pregnant women and their offspring in relation to~     these compounds, and to establish a biorepository for further studies.~      Specific Aims:~        1. To assess Heavy metals, VOCs, PBDEs and phthalates body burdens through measurement of~          these chemicals in maternal and paternal serum and urine, cord blood, breastmilk and~          neonatal meconium among several representative sub-populations.~        2. To examine associations between exposure to heavy metals, VOCs, PBDEs and phthalates and~          (a) pregnancy complications, (b) anthropometrics at birth (i.e. birth weight adjusted~          for gestational age, ponderal index, head circumference adjusted for gestational age),~          and (c) cryptorchidism incidence, (d) maternal and infant thyroid function.~        3. To establish a bio repository of these media for future studies and to establish follow~          up methods for this cohort to later assess development and growth in the infants,~          toddlers and children.~      Patients and Methods:~      Patients will be recruited from three delivery rooms in Israel: Assaf Harofeh Medical~     Center , Lis (Sorasky) Medical Center and Rambam Medical Center, all together with~     around 21,000 births annually, representing all sub-populations in Israel. 500~     mother-father-infant trios (for a total of 4500) will be recruited.~      When arriving to the delivery room, after signing the informed consent, blood and urine will~     be withdrawn from the mothers and fathers for Heavy metals, VOCs, PBDEs and phthalates~     levels. At the same time thyroid function tests will also be taken from the mothers. After~     delivery, cord blood will be taken, as well as meconium from the neonate. Hair, nails and~     Breastmilk will also be collected. From the mothers The samples will be analyzed for heavy~     metals, VOCs, PBDEs and phthalates. During their stay at the hospital, mothers and fathers~     will fill out a standardized questionnaire regarding life style factors, background~     information, and exposure opportunities. Detailed information on family history, previous and~     present pregnancy, method of delivery, perinatal complications, and pregnancy outcome will be~     recorded from the medical files.~      Expected contribution to environmental health in Israel:~      This will be the first data on sub-populations exposure to Heavy metals, VOCs, PBDEs and~     phthalates in Israel. Neonatal meconium levels will provide important information on~     magnitude of exposure during the last months of pregnancy, and, thus, will provide insights~     into the bioaccumulative nature of these Heavy metals, VOCs, PBDEs and phthalates during~     early stages of human development, important data for future risk assessments. Our~     comprehensive approach will provide detailed information on the status of each subject. Such~     novel knowledge would also lead to the development of preventive and counseling strategies~     for men and women with high BFR and phthalates exposure in order to minimize the risks of~     adverse outcomes. Knowledge transfer strategies are essential in order that the general~     public, health professionals, scientists and policy/law regulators have the appropriate~     knowledge on which to base their understandings and recommendations for the future. In this~     way, the knowledge that is generated will facilitate the development of prevention strategies~     to minimize health risks of Israel population.~   "
36838|NCT03084432|"~     The primary objective was to determine whether caffeine therapy is associated with decreases~     bone mineral content using dual energy x-ray absorptiometry. Secondary objectives were to~     determine whether caffeine therapy is associated with increased incidence of nephrocalcinosis~     or bone fracture.~   "
36839|NCT03084419|"~     Early initiation of treatment for Rheumatoid arthritis (RA) can prevent several of the long~     term problems associated with the condition. However, many RA patients develop lung~     inflammation and scarring, called 'interstitial lung disease' (RA-ILD), contributing to early~     death in 1 in 5 people. There is no proven treatment for these patients and some medications~     for RA can in fact worsen their lung disease. There is an urgent need therefore to find safe~     medications that can not only control RA joint disease, but also prevent progression of~     RA-ILD. Abatacept is an approved drug for treating RA and is used widely. It is a newer RA~     medication, with a unique mechanism of action, and it has been shown to prevent progression~     of joint damage and improve physical function. The investigators aim to assess the safety of~     this medication in patients with RA-ILD and improve our understanding of the mechanism of~     lung damage in rheumatoid disease.~      The investigators will perform a small clinical trial to assess the feasibility of performing~     a larger randomised controlled trial. A total of 30 patients with RA-ILD will be treated with~     abatacept infusions fortnightly for the first month, then every 4 weeks for a total of 20~     weeks. In order to be eligible for the study, a patient must be able to provide written~     informed consent, be aged ≥18 years, have moderate to severe RA joint disease activity (DAS28~     ≥3.2) and have interstitial lung disease that has not responded to or progressed over 6~     months despite conventional immunosuppression. Change in lung function (forced vital~     capacity) at 24 weeks will be evaluated. To assess the mechanisms that may be involved with~     the development of ILD, the investigators will assess the effects of abatacept on biomarkers~     obtained from the blood and the lung (bronchoalveolar lavage), including markers of infection~     (the lung microbiome).~   "
36840|NCT03084406|"~     The pilot test of Centervention-ATOD, a customizable suite of online tools specifically~     designed to support quality implementation and sustainability of any ATOD-EBP within~     real-world service settings, will evaluate whether the product awards additive benefits in~     provider implementation proficiency and efficacy, quality of implementation delivery, and EBP~     (i.e., Free Talk or CHOICE) outcomes compared to traditional implementation methods.~     Additionally, a cost-effectiveness study will be conducted to assess whether the~     implementation support strategy (i.e., Centervention-ATOD) is more cost-effective than~     traditional implementation methods.~   "
36841|NCT03084393|"~     To study on the Postoperative Cognitive Dysfunction: Correlations With the Gene Polymorphism~     and the Concentrations of Plasma Homocysteine, Folic Acid and Vitamin B12. To explore whether~     the gene polymorphism and the concentrations of plasma homocysteine, folic acid and vitamin~     B12 could be used as predictor(s) of POCD and to provide reference for POCD prevention, early~     detection and timely diagnosis and treatment.~   "
36842|NCT03084380|"~     The goal of this clinical trial is to evaluate the safety and efficacy of anti-GPC3~     scFv-41BB-CD3ζ-tEGFR chimeric antigen receptor (CAR)-modified T (CAR-T) cells in treating~     patients with GPC3-positive advanced hepatocellular carcinoma (HCC).~   "
36843|NCT03084367|"~     This is a pilot study designed to assess the relationship between iFR pullback and the~     distribution of coronary atheroma/stenoses as assessed by Quantitative Coronary Angiography~     (QCA) post angiographically successful PCI.~   "
36844|NCT03084354|"~     Background.~      Although a healthy urinary system is a vital aspect in every woman's life, bladder management~     is an aspect of maternity care, which is, or perceived as, being poorly managed by health~     care professionals. Furthermore, although the relationship between childbirth and bladder~     dysfunction is an incontestable fact very well documented in the medical literature, women's~     experiences of bladder care have not been recognized by the evidence, and therefore, no~     research has been developed to address this topic. This fact implies a limited level of~     awareness and degree of implication from women in this matter.~      Research question.~      What are women's experiences, perceptions and knowledge of bladder care during the~     antepartum, intrapartum and postpartum period?~      Aim.~      To explore women's experiences of bladder care during the antepartum, intrapartum and~     postpartum period.~      Design.~      Exploratory, descriptive research study.~      Population.~      Women who have given birth to a singleton, live, term baby between two weeks and six months~     prior the study, and who meet the inclusion and exclusion criteria.~      Methods.~      In-depth semi-structured interviews.~      Sample.~      A purposive sample of eight to sixteen women, with a heterogeneous representation of the~     different modes of birth, will be sought.~      Recruitment.~      Postnatal midwives will act as gatekeepers identifying potential participants and providing~     information packs. Other recruitment resources will include posters and a study website,~     which will be advertised at local maternity groups.~      Data collection.~      Semi-structure interviews to gain a deep understanding of women's experiences of maternity~     bladder care. Interviews will last between thirty minutes to a couple of hours and they will~     be digitally recorded and transcribed verbatim.~      Data Analysis.~      Framework analysis assisted by memoing technique.~      Ethical considerations.~      Ethical approval from the Sponsor and the Health Research Authority will be sought.~   "
36845|NCT03084341|"~     The main objective of this study is to compare the effect and the duration of the~     Neuromuscular Electrical Elongation (NMEE ) technique versus the PNF technique and versus a~     control group, on the extensibility of the hamstrings muscles.~      Hypothesis:~      NMEE of shortened hamstrings muscles in healthy subjects, compared with PNF and control group~     produces a significant increase in hamstrings extensibility.~   "
36858|NCT03084172|"~     Based on clinical evidence based medicine and organizational management model, investigators~     redesign the prevention and treatment of chronic kidney disease of public health system in~     Shanghai China. The investigators hope to find early chronic kidney disease, prevention and~     clinical intervention of orderly combination. The advantages of this system were confirmed by~     comparing the prevalence rate, awareness rate and treatment rate before and after the~     completion of the system.~   "
36848|NCT03084302|"~     The investigators will study sedentary behavior (SED) across pregnancy in young women. We~     hypothesize that SED will increase across pregnancy and that higher SED will be related to~     worse cardiovascular health, specifically elevated blood pressure (BP) and excessive~     gestational weight gain (GWG). Pregnancy is a biologically relevant period during which CVD~     risk factors may develop or worsen, contributing to future CVD. Pregnant women also spend~     most of their day sedentary, which is defined as too much sitting as distinct from too little~     exercise. SED has emerged as a risk factor, independent from moderate-to-vigorous physical~     activity (e.g., exercise), for elevated BP, obesity, diabetes, CVD, and mortality in general~     populations, but there are no recommendations for SED during pregnancy and few studies~     evaluate SED across pregnancy. These few studies are limited by small sample size, lack of~     repeated measures across trimesters, suboptimal SED assessment methodology, and a failure to~     link with clinical outcomes (e.g., BP, GWG). The investigators will address these gaps in a~     prospective study that will measure SED in 130 pregnant women across three trimesters using~     state-of-the-art objective activity monitors capable of measuring min-by-min activity by both~     intensity and posture. We will also measure BP and GWG during each trimester and, further,~     will link to and abstract all prenatal clinic weights and BPs, glucose screening results,~     gestational diabetes, preeclampsia, and adverse birth outcomes. Lastly, with the long-term~     goal of identifying women at high risk of SED during pregnancy and designing effective~     interventions, the investigators will efficiently evaluate correlates and determinants of SED~     which have never been studied during pregnancy.~   "
36849|NCT03084289|"~     The purpose of this study is to assess the safety and immunogenicity of novel routes of~     administration of the candidate malaria vaccines ChAd63 encoding ME-TRAP and MVA encoding~     ME-TRAP.~      30-33 Healthy adult volunteers will be recruited in Oxford.~      All vaccinations will be administered intravenously or subcutaneously. Each volunteer will~     receive a single vaccination of ChAd63 ME-TRAP or MVA ME-TRAP at different doses depending on~     the group.~   "
36850|NCT03084276|"~     Aim: to determine to what extent meal composition influences postprandial sensations~     independently of palatability. The postprandial responses to a low-fat (240 Kcal) versus a~     high-fat (275 Kcal) test meal (150 g humus) with the same physical and organoleptic~     characteristics (taste, smell, colour, texture, consistency, temperature) will be studied on~     a cross-over design. The responses to the meals will be tested on 2 different days.~     Participants (12 non-obese healthy men) will be instructed to eat a standard dinner the day~     before, to consume a standard breakfast at home after overnight fast, and to report to the~     laboratory, where the test meal will be administered 3 h after breakfast. Studies will be~     conducted in a quiet, isolated room with participants sitting on a chair. Perception will be~     measured at 5 min intervals 10 min before and 20 min after ingestion and at 10 min intervals~     up to 60 min after the probe meal.~   "
36851|NCT03084263|"~     The objective of this study is to compare the functional outcomes of patients with ankle~     fractures treated by Arthroscopic assisted Open Reduction Internal Fixation (AORIF) versus~     Open Reduction Internal Fixation (ORIF).~   "
36852|NCT03084250|"~     The CHB subjects who are cirrhosis, will be randomized to two groups.~      The subjects who go into group A will be treated by nucleotide analogue (NA) combination with~     peginterferon alfa-2a,180μg/week for 48 weeks.~      The subjects who go into group B will be treated by nucleotide analogue (NA) only for 48~     weeks.~   "
36853|NCT03084237|"~     This is a Phase III, double-blind, randomized multicenter study to compare the efficacy and~     to evaluate the safety and immunogenicity of HLX02 and European Union (EU)-sourced Herceptin®~     in patients with human epidermal growth factor receptor 2 (HER2)-positive, locally recurrent~     or previously untreated metastatic breast cancer.~   "
36854|NCT03084224|"~     For some neurological and neurodegenerative diseases genetic inheritance is well documented~     (described as Mendelian or multifactorial), but sometimes specific mutations or family~     segregation evidences have not been identified. Considering this scenario, most of the times~     it is impossible or unlikely to identify the responsible gene, or the private mutation, of a~     patient affected by a neurodegenerative disease.~      New technologies such as Next Generation Sequencing (NGS), allow the analysis of hundreds of~     genes in a single experiment. The implementation of these technologies will help to identify~     new genes and new variants associated with neurological diseases. Using this approach,~     several molecular genetic diagnosis will definitely find the needle in a haystack, and will~     be able to be used in the clinical practice.~   "
36855|NCT03084211|"~     Introduction: Current guidelines for treating patients with mild traumatic brain injury~     (MTBI) recommend a period of cognitive rest and gradual return to usual activities with~     avoidance of any activity that exacerbates symptoms. However, recent studies have reported~     prolonged rest beyond 48 hours might hinder MTBI recovery, and there is limited evidence to~     suggest following guidelines has a positive impact on prognosis. Given the paucity of~     effective management strategies to prevent post-concussion syndrome (PCS) and emerging~     evidence of the benefits of exercise in MTBI patients, there is an urgent need for more~     research on the effectiveness of an early exercise intervention in the acute MTBI patient~     population as prevention of PCS.~      Research Question: Among adult (18-64 years) patients presenting to the ED with a discharge~     diagnosis of acute MTBI (defined by the Zurich consensus statement), does prescribing light~     exercise (ie: 30 min daily walking) reduce the proportion of patients with PCS at 30 days,~     compared to standard discharge instructions?~      Methods: This will be a randomized controlled trial of adult (18-64 years) patients~     discharged from an academic ED diagnosed with MTBI occurring within 48 hours of the index ED~     visit. The intervention group will receive discharge instructions prescribing 30 minutes of~     light exercise (ie: walking) and the control group will be instructed to gradually return to~     activities. Discharge instructions will be read by the attending physician or ED nurse.~     Patients will be provided a printed copy of the discharge instructions. Depending on their~     preferences, patients will be contacted by email or by telephone to complete the Rivermead~     Post-Concussion Symptoms Questionnaire (RPQ), a validated, 16 item questionnaire.~      The primary outcome of this study will be the proportion of patients with PCS at 30 days,~     defined as an increase from baseline of ≥ 3 symptoms on the validated RPQ at 1 month.~     Secondary outcomes will include change in RPQ from baseline to 72 hours, 7 days, 14 days, 30~     days post initial ED visit, number of missed days of school or work and repeat visits to a~     healthcare provider. To assess compliance with ED discharge instructions, patients will be~     asked to complete a daily activity journal and will be given fitness tracking devices.~   "
36856|NCT03084198|"~     This study tend to evaluate safety and efficacy of hiHep bioartificial liver support system~     in treating acute liver failure.~   "
36857|NCT03084185|"~     This is a single-center and prospective study to identify specific biomarker in order to~     predict development of decompensation in cirrhotic patients.~      The duration of the study is 36 months and it provides a cohort of 200 patients.~   "
39420|NCT03050710|"~     In this study, eligible subjects with moderate to severe nasolabial folds will be treated~     with Princess® VOLUME Lidocaine and will return for follow-up assessments 2, 4, 24 and 36~     weeks after the treatment. A Touch-up treatment may be done at Week 2, if deemed appropriate~     by the investigator.~   "
36859|NCT03084159|"~     This study will use an adapted education worksheet to support patient-centered chronic kidney~     disease (CKD) communication, shared decision making, and patient engagement and will test its~     impact on intermediate patient modifiable characteristics in a primary care practice with~     patients who have pre-dialysis CKD.~      The study team will enroll up to 50 patients with chronic kidney disease (CKD) from a primary~     care clinic to start. Patients will receive the intervention, which consists of the~     physicians using the education worksheet during appointments with patients, and patients and~     providers will complete surveys about its use and to measure impact on knowledge and other~     areas related to patient outcomes.~      Once initial user testing is complete, the study team plans to submit an amendment to expand~     on this trial and incorporate comparison sites. This will be submitted and receive IRB~     approval prior to participant involvement.~      The study hypothesis is that patients who receive the intervention will have greater~     knowledge about their CKD diagnosis, higher satisfaction with provider communication, and~     higher scores related to managing CKD to keep themselves healthy compared to control~     populations.~   "
36860|NCT03084146|"~     Psoriasis is a common chronic skin disorder that affects over 4 million people. There is no~     cure for psoriasis and treatment is directed at controlling patients' symptoms. The purpose~     of this study is to determine whether psoriasis patients are more likely to have food~     sensitivities than those patients without psoriasis. We will also determine if eliminating~     certain foods from the diet results in a change in psoriasis symptoms.~   "
36861|NCT03084133|"~     The relative risk of colorectal cancer (CRC) is increased in first-degree relatives of~     patients with CRC or advanced adenoma. In the high-risk CCR population defined by a family~     history at the first stage of CRC or advanced adenoma before age 60, total colonoscopy is the~     recommended screening test. In France, the rate of screening colonoscopy in this population~     at high risk of CRC is insufficient, which limits the effectiveness of this targeted~     screening.~      The main reason for this low participation rate is that most patients undergoing RCC or~     advanced adenoma are unaware of the family implications of their diagnosis and therefore~     reluctant to disseminate this information to their patients Related matters. The need for a~     better perception of the personal risk of CRC in first-degree relatives of patients with CRC~     or advanced adenoma, with the expected coronary adherence to increasing screening, requires a~     good understanding of risk through Clear, adapted and comprehensible information that can be~     relayed personally by the case-index.~      The objective of this project is to develop a personalized prevention and screening program~     for the JRC in order to meet the needs of the relatives of the sick. The means of~     intervention that will be implemented respond to the need to better take into account the~     level of CRC risk in a family-based CRC screening and prevention approach adapted to a~     high-risk CRC group characterized by Family history at the first stage of CRC or advanced~     adenoma and, consequently, to improve the information of the subjects concerned by screening~     and prevention of CRC.~      The aim of the case-index education is to induce its intervention with its relatives to~     promote CCR screening. The use of the index case, as a means of providing information to~     relatives, implies an educational and psychological approach, based on evidence, but adapted~     and personalized.~   "
36862|NCT03084120|"~     This study evaluates effect of the Maternal Obesity and/or the By-pass on the Growth and the~     Nutritional Balance of the Child.The data stemming from mothers presenting obesity or an~     overweight during their pregnancy and the data stemming from mothers having had a by-pass~     will be compared with the data stemming from mothers with a normal BMI (Body Mass Index),~     considered as a reference group. It's the same for the data stemming from newborn children.~     The newborn children stemming from groups of obese mothers or in overweight will be compared~     with the data stemming from mothers belonging to the reference group.~   "
36863|NCT03084107|"~     The aim of this project is to create ten smart devices that involve combining an interactive~     art environment with IC technology, arts and health administration. Investigators invited the~     elderly residents of Chang Gung Health and Culture Village to participate in the application~     of these devices, and participants were also requested to complete a technology acceptance~     model (TAM) questionnaire for these smart devices.~   "
36864|NCT03084094|"~     One of the big challenges faced by researchers who act in rehabilitation science is the~     capacity to dispose integrative approaches for its utilization in clinical practice. The~     border profile of a physiotherapy researcher is to be in front of applied research~     amplification in experimental integrative approaches, involving the study of behavioral and~     physiological variables.~      The rehabilitation process transcends the systems physiology and encompasses the cognitive~     behavioral feature of being adapted to the environment that surround us. It is now known by~     the scientific rehabilitation community the necessity for evidence based therapies and even~     more, therapeutic innovation. In both conditions, of health and illness, various options to~     use integrative approaches are today available in physiotherapy, including behavioral and~     physiological profiles of the individuals during physical activities, response to stress and~     in the field of chronic pain.~      It is in the clinical routine of numerous rehabilitation centers the treatment of diseases~     that causes pain, being the leading figure in a physiotherapist work process. The innovative~     study of resources that can alter the pain state of this patients becomes primordial for~     routine clinical use, low cost and easy to apply. The therapeutic treatment for pain offered~     by a physiotherapist need new investigative options based in evidences from the association~     between the neuronal, behavioral and physiological responses where the brain is the central~     organ of this regulation. In this context, become increasingly more necessary the~     construction of investigative approaches in the purpose of reaching the clinical practice, in~     a reduced time lapse, once the great volume of information produced globally does not impact~     in short or medium term in new therapeutic recommendations.~      Among the various chronic painful entities, it is presented the fibromyalgia (FM), painful~     diabetic polyneuropathy and primary dysmenorrhea because of its painful pathogenic complexity~     and its limited therapeutic against pain in rehabilitation process. The 3 painful entities~     presents the central nervous system as main participant of neurogenesis and maintenance of~     the painful state.~      It is primordial importance that rehabilitation science improve methods of non invasive brain~     neuromodulation that allows, through excitation or inhibition of specific cortical areas in~     order to produce pain inhibition, providing a simple and low cost treatment to clinical~     routine. Technological advances and non invasive techniques to modulate brain function has~     been developed, among which transcranial direct current stimulation (tDCS) stands out.~     Basically, electrodes are placed in targeted brain regions that you want to stimulate or~     inhibit. Posteriorly, is applied a continuous electric current (0,4 - 2 mA) for a 3-20~     minutes period, in order to modify cortical excitability. The stimulus of the anodic current~     increases cortical excitability whereas the stimulus of the cathodic current has an~     inhibitory effect.~      Few are the research groups that address the issue of fibromyalgia, painful diabetic~     polyneuropathy and primary dysmenorrhea and the application of tDCS as research focus, being~     a border area for rehabilitation science and great potential in clinical use. Preliminary~     studies associates the use of tDCS with the decrease of painful state, however an approach of~     physical function and behavioral results needs greater investigation.~      The purpose of the presented project is to present the tDCS as a new modality in physical~     rehabilitation for the patient with chronic pain of the 3 entities mentioned above. The study~     proposal is to present behavioral, social and physical results of tDCS application in this~     patients, suggesting a better quality of life and functionality of the individual.~   "
36865|NCT03084081|"~     The purpose of this academic-industrial partnership will compare the CryoPen® and~     thermoablator to traditional CO2-based cryotherapy for the treatment of cervical precancer in~     low and middle income countries (LMICs) and investigate whether the cure rates of cervical~     intraepithelial neoplasia 2 and more severe diagnoses (CIN2+) with these devices are~     non-inferior compared to that of conventional cryotherapy. The results of this study will~     affect other research areas by serving as a springboard to exploring treatment alternatives~     that are amenable to low-resource settings and thus will reach the most vulnerable~     populations.~   "
36866|NCT03084068|"~     To determine the effectiveness of human dehydrated umbilical cord allograft in standard open~     rotator cuff repair as assessed by the American Shoulder and Elbow Surgeons (ASES) score 12~     months post-op.~   "
36867|NCT03084055|"~     Physical activity has many potential mood enhancing benefits, and may be as effective as~     anti-depressants and psychological therapies for treating depression and low mood. However,~     getting people with depression to become more active is challenging. Behavioural Activation~     (BA) is an evidenced based psychotherapeutic treatment that focuses on increasing exposure to~     positive environmental stimuli which could provide an effective delivery mechanism for~     increasing physical activity for people who are more sedentary than the general population.~     The purpose of this study is to examine the feasibility of delivering a theory informed~     online intervention combining physical activity and BA (eMotion) to people with depression,~     and to examine its effects on depressive symptoms and physical activity.~   "
36868|NCT03084042|"~     This study aims to 1) examine common and specific emotional and cognitive dysfunctions~     between Major Depression and generalized anxiety disorder; 2) Examine emotional and cognitive~     dysfunctions between the two disorders and healthy controls; 3) Examine the biomarkers~     predicting successful therapy or not.~   "
36869|NCT03084029|"~     The main focus of this study is to examine oxytocin effects on behavioral and neural indices~     of empathy processing.~   "
36870|NCT03084016|"~     This study aims to assess the feasibility of capturing data on exhaled breath compounds~     during an acute asthma exacerbation. In addition to assessing the feasibility of such a study~     the investigators will collect data on exploratory outcomes including the ability of breath~     biomarkers to distinguish between controlled and exacerbated states and their ability to~     differentiate between triggers of exacerbation.~   "
36871|NCT03084003|"~     The purpose of the study is to examine the effects of almond snacking on metabolic,~     cardiovascular and microbiome profiles in college freshmen.~   "
36872|NCT03083990|"~     To confirm the PK similarity of IBI305 and bevacizumab in healthy volunteers .~   "
40097|NCT03041883|"~     The purpose of this study is to demonstrate the safety and efficacy of the corneal collagen~     crosslinking with riboflavin and ultraviolet A in aim to increase the resistance of the graft~     used as a support for the Boston keratoprosthesis (KPro) type I against corneal melting~     (keratolysis or sterile necrosis).~   "
36873|NCT03083977|"~     Chronic pain is a common ailment in aging populations and often co-occurs with altered~     regulation of the autonomic nervous system. Nociceptive pathways (i.e., those that transmit~     pain signals) are integrated with autonomic circuits throughout the body and therapies that~     are successful in reducing pain concurrently alter autonomic functions, even when they are~     not directly designed to do so. It is possible that interventions that target the autonomic~     circuits that regulate pain responses may help reduce pain in chronic pain sufferers. The~     proposed study will examine whether an intervention that targets the autonomic nervous system~     via filtered music can reduce pain, a hypothesis derived from the Polyvagal Theory.~      The Polyvagal Theory describes how function and structure of the vertebrate autonomic nervous~     system changed during evolution. The theory is named for the vagus, a major cranial nerve~     that regulates bodily state. An evolutionary old branch of this nerve innervates structures~     below the diaphragm and its dysfunction is linked to lower body organ and tissue pain.~     Regulation of the vagus nerve is linked with specific auditory cues based on our evolutionary~     heritage and the physics of the middle ear. This study is designed to test whether processed~     music designed to stimulate vagal function can decrease chronic pain. The Listening Project~     Protocol, the processed music used in this intervention, has previously been shown to~     effectively stimulate the function of the vagus nerve (see stimulus description below).~      Specific Aims:~      Aim I: To examine whether The Listening Project Protocol, a non-invasive audio intervention,~     can be effective for reducing chronic pain in a sample of older adults.~      Hypothesis: Five 1-hour sessions of the Listening Project Protocol will reduce pain~      Aim II: To examine whether increased regulation via the autonomic nervous system accounts for~     the decrease in pain if the intervention is successful.~      Hypothesis: Pain reduction will coincide with improved autonomic function by the myelinated~     vagus nerve (measured by respiratory sinus arrhythmia, see below) as well as decrease in the~     reactivity of autonomic functions in everyday experiences (measured by the Body Perception~     Questionnaire, see below)~   "
36874|NCT03083964|"~     The purpose of this study is to A) capture obesogenic cues that occur in daily life, and B)~     to deliver cue alerts. Investigators hypothesized that A) black women experience more cues,~     B) racial disparities in obesity are reduced in models that adjust for cues, and C) the~     priming arm will achieve a weight loss of 2kg or more. Investigators will explore whether~     racial disparities in weight loss differ between the groups receiving usual care or those~     receiving cues.~   "
36875|NCT03083951|"~     A randomized, controlled clinical trial comparing lymphadenectomy with extended inferior~     mesenteric artery ligation (complete mesocolon excision: which includes lymphoma tissue from~     the origin of the inferior mesenteric vein) with conventional locoregional lymphadenectomy in~     patients undergoing laparoscopic sigmoidectomy for sigmoid cancer.~   "
36876|NCT03083938|"~     Despite the fact that pancreatoduodenectomy is the standard treatment of malignant tumor at~     periampullary area, the morbidity and mortality rate with intra-abdominal collection, post~     pancreatectomy hemorrhage, and delayed gastric emptying, is still high at approximately~     50-60%. The causes of these complications usually come from post-operative pancreatic~     fistula. Nowadays, several methods have been reported to reduce the incidence of pancreatic~     fistula after undergoing pancreatoduodenectomy, such as pancreatic stenting, the use of~     intravenous somatostatin, the use of sealant material and wrapping anastomosis by soft~     tissue.~      Wrapping pancreato-jejunal anastomosis with omentum is not a complicate procedure and~     requires no extra treatment expenses of the patient. It has been reported this technique has~     been applied in the non-randomized controlled trials and their data have significantly shown~     that the technique could reduce pancreatic fistula rate. Therefore, the researchers want to~     conduct an RCT study to compare complication rates between omental roll-up pancreato-jejunal~     anastomosis and non-omental roll-up groups.~   "
36877|NCT03083925|"~     To evaluate the clinical benefits in the patients receiving Viatorr CX over a period of 12~     months of structured Follow-up (before TIPS, at TIPS, 1 week after TIPS, at 6 weeks, 4~     months, 6 months, 9 months, 12 months), regarding clinical endpoints, such as HE,~     readmission, liver injury, cardiac function, response to TIPS and the passive expansion of~     the stents in real life.~   "
36878|NCT03083912|"~     The hypothesis of this study is that the administration of a high-calorie high-protein oral~     nutritional supplement twice a day for three months to elderly malnourished in residents in~     Spain is associated with improved nutritional status, with an increase in body weight of~     between 5 and 8%, and an improvement in functional status, with low incidence of~     complication.~   "
36879|NCT03083899|"~     People with Type 1 diabetes (T1D) are randomized to follow the normal scheduled visit~     procedure in the outpatient clinic OR to have open access to the clinic, i.e. they can get an~     appointment with a nurse or doctor within defined time intervals via telephone, e-mail or~     apps. Patient-reported outcomes, clinical variables (HbA1c, blood pressure etc.) and use of~     human resources (doctors, diabetes-nurses and diet physicians) are monitored.~   "
36880|NCT03083886|"~     Low back and neck pain are among the leading causes of medical visits, lost productivity and~     disability. There is an urgent need to identify effective and efficient ways of helping~     subjects with acute spine pain while guiding practitioners towards high-value care. This~     trial will be a block and cluster-randomized open-label multi-centered pragmatic randomized~     clinical trial comparing healthcare spending and clinical outcomes for subjects with spine~     pain of less than three months' duration, in whom there are no red flag signs or symptoms.~     Subjects will be randomized to one of three treatment strategies: (1) usual primary care~     provider-led care; (2) usual PCP-led care with spine pain treatment directed by the Identify,~     Coordinate, and Enhanced decision making (ICE) care model, and (3) usual PCP-led care with~     spine pain treatment directed by the Individualized Postural Therapy (IPT) care model. Our~     outcomes of interest will be spine-related healthcare utilization at one year as well as pain~     and functionality of the study participants.~   "
36881|NCT03083873|"~     Prospective, multicenter, single-arm, open label, interventional study evaluating adoptive~     cell therapy (ACT) with autologous tumor infiltrating lymphocytes (TIL) infusion (LN-145)~     followed by IL-2 after a non-myeloablative (NMA) lymphodepletion preparative regimen for the~     treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head~     and neck~   "
36882|NCT03083860|"~     Evaluation of migraine management mobile app combined with electrophysiological measurements~     for identification of migraine attack risk and beneficial preventive actions.~   "
36896|NCT03083678|"~     In this phase 2, single arm trial patients with locally advanced or metastatic,~     pathologically proven, EGFR expressing chordoma will be treated with afatinib. Two cohorts of~     patients will be included: 20 first line patients and 20 second or further line patients. The~     treatment will be given in 4 week cycles until disease progression. Median PFS according to~     RECIST 1.1 will be evaluated. The objective is to increase the median PFS ≥ 12 months in~     first-line treatment cohort and ≥ 9 months in later-line treatment cohort. Additional~     exploratory research will be performed, consisting of a pharmacokinetic study and~     translational studies on EGFR pathway activation and signalling on blood and tumor samples.~   "
36883|NCT03083847|"~     Background:~      People get malaria from bites from infected mosquitos. Researchers are studying a vaccine~     strategy. They will give people malaria parasites by injecting them with live infectious~     malaria parasites with antimalarial medications and then see if this strategy prevents~     malaria infection while off antimalarial medications.~      Objective:~      To see if combining a high dose of live, infectious malaria parasites (known as Sanaria PfSPZ~     Challenge) and two FDA approved drugs that kill malaria parasites (pyrimethamine [PYR] OR~     chloroquine [CQ]) is safe and can provide people protection against malaria.~      Eligibility:~      Healthy adults ages 18-50 who:~        -  are not pregnant or breastfeeding or planning on becoming pregnant while in the study~        -  are not infected with HIV, Hepatitis B or Hepatitis C~        -  have reliable early morning access to the NIH Clinical Center~        -  are able to come to the outpatient clinic frequently, sometimes daily~        -  have not been diagnosed with malaria within the past 10 years~      Design:~        -  Participants will be screened with medical history and physical exam. They will have~          heart, blood, and urine tests.~        -  Participants will have blood drawn for tests at most visits.~        -  Participants will keep track of their temperature and symptoms during some sections of~          the study.~        -  Participants will join one part of the study.~      Part 1 is one month:~        -  Participants will get the parasites by an injection into a vein on day 1 and receive~          antimalarial medications.~        -  They will have daily visits on days 7-14~        -  They will take another antimalarial at visits on days 15-17.~        -  The final visit will be on day 29.~      Part 2 is seven months:~        -  For the first 3 months, participants will get the parasite injection into a vein for 3~          injections in total. Each injection will occur once per month while taking an~          antimalarial drug.~        -  They will have daily visits on days 7-14 after the first injection, and on days 7-11~          after the second and third injection.~        -  They will have a final (fourth) injection around month 6 without any antimalarial~          medication.~        -  After this fourth injection, participants may have up to 21 daily visits from day 7~          after injection until end of study.~      Part 3 is one month:~        -  Participants will get the parasites by injection into a vein on day 1 without~          antimalarial medications.~        -  They will have visits almost every day starting day 7 from injection.~        -  They will take an antimalarial medication when they are diagnosed with malaria~        -  They will return for final end of study visit on days 27-29.~   "
36884|NCT03083834|"~     In mitotane treated patients, serum cortisol cannot be used to diagnose hypoadrenalism, since~     mitotane increases cortisol binding globulin levels (CBG), artificially raising total~     cortisol. Salivary free cortisol (SC) is not affected by CBG alterations, and reflects the~     free serum cortisol.~      In the current study, investigators will assess serum and SC responses during low-dose~     cosyntropin stimulation test in healthy volunteers, mitotane-induced hypoadrenal patients on~     steroid replacement therapy and in patients who suffer from hypoadrenlism caused from other~     etiology. Investigators will compare results between groups and try to demonstrate the~     superiority of SC in assessing adrenal function in mitotane treated patients.~   "
36885|NCT03083821|"~     A Pharmacokinetics study of Baraclude in a real world clinical setting in Japan.~   "
36886|NCT03083808|"~     This is a single-arm phase II study of continuation immunotherapy with pembrolizumab~     following initial benefit (CR, PR, or SD ≥ 3 months) with a PD-1 or PD-L1 inhibitor.~   "
36887|NCT03083795|"~     This study will determine the feasibility and effectiveness of a monthly social support group~     along with a weekly peer-to-peer meeting in improving perceived level of social support,~     diabetes distress, and A1c profiles in patients with Type II diabetes mellitus, compared with~     standard care offered at British Columbia Diabetes (BC Diabetes).~   "
36888|NCT03083782|"~     This study aims to evaluate the pharmacokinetics (PK) of apixaban when co-administered with~     cyclosporine and tacrolimus in healthy volunteers. The study participants will receive~     apixaban alone, cyclosporine followed by apixaban and tacrolimus followed by apixaban.~   "
36889|NCT03083769|"~     The purpose of this study is to determine whether functional genetic variants can affect~     tacrolimus dose corrected trough levels and associate with the side effects in Chinese renal~     transplantation and liver transplantation.~   "
36890|NCT03083756|"~     This study validate the usefulness of SIMPLICITY score to characterize the immune status of~     the kidney transplant receiver at two points along its course (the one and six months after~     transplantation), by determination in peripheral blood of various parameters related to~     cellular immunity (count subpopulations of CD3+ (cluster of differentiation 3), CD4+ (cluster~     of differentiation 4) and CD8+( cluster of differentiation 8)), humoral immunity~     (immunoglobulins count) and innate (complement).~   "
36891|NCT03083743|"~     The trial is to evaluate the efficacy and safety of recombinant human Apo-2 ligand in~     treating patients with advanced retreated non-small cell lung cancer~   "
36892|NCT03083730|"~     Atopic dermatitis (eczema) is a chronic inflammatory disease that causes significant~     morbidity and is now known to be associated with cardiovascular disease. Research such as~     this will add to the understanding of the skin as a contributor to systemic inflammation, and~     it is important to clarify whether skin-only treatment can alleviate systemic inflammation,~     and potentially influence cardiovascular risk factors.~   "
36893|NCT03083717|"~     Application of Nanotechnology and Chemical Sensors for Diagnosis of Decompensated Heart~     Failure by Respiratory Samples.~      Breath testing, which links specific volatile molecular biomarkers in exhaled breath to~     medical conditions, is becoming increasingly popular as a non-invasive and potentially~     inexpensive diagnostic method for various diseases. NA-NOSE performs odor detection from~     exhaled breath, thus producing a distinct fingerprint for each mixture of analytes.~      Several studies have been published, stating the advantages of these sensors, leading to~     promising outcomes in several fields.~      The NA-NOSE breath test would be fast (examination and results would be obtained within 5-10~     min), inexpensive, eventually portable (smaller than desktop computer), non-invasive and free~     of any side effects.~   "
36894|NCT03083704|"~     This is a randomized, double-blind, study in healthy volunteers dosed to steady state with~     fXa inhibitors, designed to (1) demonstrate PK/PD comparability between andexanet~     manufactured by the Generation 1 and Generation 2 processes, (2) evaluate the degree to which~     the Generation 2 andexanet reverses fXa-inhibitor-induced anticoagulation in comparison to~     placebo, and (3) evaluate safety of Generation 2 andexanet.~   "
36895|NCT03083691|"~     BIOLUMA is a multicentric non-randomised phase II trial in patients with non-squamous~     non-small cell lung cancer (NSCLC) (Cohort 1) and patients with small-cell lung cancer (SCLC)~     (Cohort 2) after failure of platinum-based first-line therapy. NSCLC patients are treated~     with nivolumab until disease progression and subsequently receive a combination therapy of~     nivolumab and ipilimumab. SCLC patients receive four cycles of nivolumab in combination with~     ipilimumab and subsequent nivolumab monotherapy. Primary endpoint for both cohorts is overall~     response rate of combination therapy.~      Within the diagnostic part tumor biopsies will be analysed. Tumor tissue will be obtained~     before initiation of therapy and after progression on nivolumab monotherapy before addition~     of ipilimumab in Cohort 1 and after completion of the four nivolumab/ipilimumab combination~     cycles before continuation of nivolumab monotherapy in Cohort 2, respectively. Flow cytometry~     of blood samples and microbiome analysis of deep rectal swaps are performed prior to therapy~     as well as during course of treatment.~   "
39894|NCT03044522|"~     This multicenter randomized (block randomization) controlled parallel arm pilot study~     comparing the incorporation vs no incorporation of a Nurse Pain Educator into clinics that~     treat chronic non cancer pain patients with opioid analgesics. Subjects who are either opioid~     naïve or opioid experienced will be enrolled into the study.~   "
36898|NCT03083652|"~     Neuromuscular electrical stimulation (NMES) implemented during the intensive care unit(ICU)~     stay may improve exercise capacity and prevent muscular weakness in critically ill patients~     with respiratory disease. Main objective: To evaluate, in respiratory critically ill~     patients, the effects of a conventional physiotherapy program with or without additional NMES~     applied only during the ICU stay on exercise capacity. Design: Randomized, controlled,~     double-blind clinical trial on patients (>18yo) with diagnosis on admission of acute or acute~     on chronic respiratory disease, on mechanical ventilation (MV) > 72h and expected MV > 24h.~     Intervention: Conventional physiotherapy with or without 30-minutes (5days/week) on~     quadriceps femoris and gluteus maximus. Patients in the control group will follow the same~     protocol but the device will not be activated. Measures: Demographic data, body composition~     through bioelectrical impedance analysis (BIA), and functional capacity before admission~     through Barthel scale will be registered upon inclusion. Exercise capacity through test~     sit-to stand, muscular strength through Medical Research Council (MRC) score and dynamometry,~     body composition through BIA, and functional capacity through Barthel scale will be obtained~     at ICU and hospital discharge.~   "
36899|NCT03083639|"~     The purpose of this study is to determine the bioequivalence of esomeprazole 40 milligram~     (mg) tablets and capsules.~   "
36900|NCT03083626|"~     This current study is intended to be completed under the umbrella of the current GHUCCTS IRB-~     approved study Opioid-Induced Hyperalgesia In Prescription Opioid Abusers: Effects of~     Pregabalin (Lyrica study) (PRO00000669). In this proposed study, 10 healthy male, 10 healthy~     female participants and 5 male, 5 female OIH participants (from the parent Lyrica study), who~     are prescription opioid abusers with chronic pain currently taking Suboxone, will be asked to~     take the cold pressor test at 1, 5, and 9 degrees Celsius and to report the time at which~     pain has completely gone away following each test. The purpose of this study is to examine~     how the water temperature of the cold pressure test might affect the participants' response~     (i.e., the participants pain threshold and pain tolerance) and to see if there is a~     difference in how each participation group is affected.~   "
36901|NCT03083613|"~     This is a single-arm clinical trial.The purpose of this study is to evaluate the efficacy and~     safety of Raltitrexed and Paclitaxel as second-line chemotherapy for patients with~     unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma .The primary~     endpoint of this study is objective response rate.The secondary endpoint of this study is~     safety,progression-free survival and overall survival.~   "
36902|NCT03083600|"~     To evaluate the effectiveness of three different daily doses of plant protein hydrolysates~     versus placebo, when consumed over a 12-week period, at reducing and maintaining glycated~     haemoglobin (HbA1c) levels in a pre-diabetic population (otherwise healthy subjects with~     impaired glucose metabolism).~      To evaluate the effectiveness of three different daily doses of pea or rice protein~     hydrolysates versus placebo, when consumed over a 12-week period on: post-prandial~     glucose/insulin levels (oral glucose tolerance test, fructosamine levels, fasting plasma~     glucose levels, vital signs, physical examinations, weight and blood pressure.~   "
36903|NCT03083587|"~     There is a growing health burden in Sweden and Europe arising from the interrelated sequelae~     of metabolic disorders comprising impaired glucose tolerance (IGT), obesity and T2DM. Obesity~     and inactivity are the main drivers of IGT and T2DM and are responsible for up to 8% of~     health costs and 13% of deaths in Europe, with the risk of co-morbidities rising in parallel~     with increasing body weight. IGT and T2DM are the paradigm of inactivity-related disorders:~     the majority of people who have IGT or T2DM are overweight and inactive, with up to 80% being~     obese. A recent meta-analysis of 42 studies concluded that sedentary time was independently~     associated with a greater risk of T2D, all-cause mortality, cardiovascular disease incidence~     and mortality, and cancer incidence and mortality (breast, colon, colorectal, endometrial and~     epithelial ovarian cancers) (Ann Intern Med. 2015;162:123-32). A recent systematic review of~     trials published up to April 2014 identified 16 separate studies and concluded that there is~     considerable evidence of the positive effects of breaking up prolonged sitting time with~     light-intensity ambulatory physical activity and standing on postprandial metabolic~     parameters, including glucose, insulin and triglyceride levels (Med Sci Sports Exerc.~     2015:47:2053-61). However, to date, all of the published experimental trials describing the~     beneficial effects of breaking up sitting time on metabolic risk markers have been restricted~     to acute exposure periods (1-5 days). We will perform a RCT intervention study, which~     examines the efficacy (clinically relevant responses) and practical implementation of~     low-impact training in sedentary obese individuals during the day.~   "
36904|NCT03083574|"~     The present project is a prospective, multicenter, non-randomized, phase II trial which aims~     to evaluate the clinical impact and the safety of extracorporeal photopheresis (ECP) using~     the Theraflex system in patients with refractory chronic graft versus host disease (cGVHD)~     after any type of hematopoietic stem cell transplantation or after donor lymphocyte infusion.~   "
36905|NCT03083561|"~     The main purpose of this study is to evaluate the safety and tolerability of LY3337641 in~     healthy Japanese and Caucasian participants. The study will also investigate how the body~     processes LY3337641 and the effect of LY3337641 on the body. The study will last up to 4~     weeks for each participant. Screening may occur within 28 days prior to first dose of study~     drug.~   "
36906|NCT03083548|"~     The Nor-Hand study is a hospital-based observational study including 300 patients with~     evidence of hand OA by ultrasound and/or clinical examination. The baseline examination~     (2016-17) consists of functional tests and joint assessment of the hands, medical assessment,~     pain sensitization tests, ultrasound (hands, acromioclavicular joint, hips, knees and feet),~     computer tomography (CT) and Magnetic Resonance Imaging (MRI) of the dominant hand,~     conventional radiographs of the hands and feet, fluorescence optical imaging of the hands,~     collection of blood and urine samples as well as self-reported demographic factors and~     OA-related questionnaires. Two follow-up examinations are planned after 4 (2020-21) and 8~     years (2024-25), respectively. Cross-sectional analyses will be used to investigate~     agreements and associations between different relevant measures at the baseline examination,~     whereas the longitudinal data will be used for evaluation of predictors for clinical~     outcomes.~   "
39895|NCT03044509|"~     1. The primary objective is to improve the sensitivity of novel immunodiagnostic tests for~          detection of TB disease in children.~        2. The secondary objective is to determine biomarkers that discriminate children with TB~          infection and disease.~   "
36907|NCT03083535|"~     Periodontal disease is a multifactorial disease caused by mainly bacterial, genetic,~     immunologically, and environmental factors. Chronic periodontitis, one of the widely~     prevalent forms of periodontal disease, is characterized by loss of attachment apparatus of~     the tooth; it can lead to tooth loss. Many non surgical and surgical approaches have been~     adapted time and again to prevent, intercept, and to treat the various forms of chronic~     periodontitis. But, these treatment modalities are not approachable by all individuals,~     because of the various factors such as: low socioeconomic status, illiteracy, high cost of~     the treatment, no availability of easy and uncomplicated treatment nearby etc. Considering~     these factors, we are still in need of preventive, practical, and affordable treatment~     options specially for the population of underdeveloped and developing countries.~   "
36908|NCT03083522|"~     The Purpose of this trial is to investigate the efficacy and safety of Ojeok-san(OJS) on~     Korean Patients With Cold Hypersensitivity in the Hands~   "
36909|NCT03083509|"~     The aim of this study to increase understanding of physiological and functional perturbations~     following a continuum of exercise stressors.~   "
36910|NCT03083496|"~     This study aims to evaluate the longevity and efficacy of two products potassium~     oxalate-basedin two concentrations, 10% and 5%, by triple randomized blind clinical trial~     (split-mouth) . The desensitization approach (single agent) and the long-term effectiveness~     (baseline, 1 week, 2 weeks, 3 weeks). Data will be collected, tabulated and submitted to~     statistical analysis.~   "
36911|NCT03083483|"~     The purpose of this study is to test the influences of transcranial direct current~     stimulation (tDCS) on the acquisition of laparoscopic surgical skills. For this purpose, the~     investigator will compare variants of tDCS in the first of 2 experiments. The second arm of~     the trial will investigate gaze training in a similar study design. These questions will be~     evaluated using the validated Fundamentals of Laparoscopic Surgery (FLS) module 1, with the~     overall goal of developing a surgical training curriculum that achieves expert level skill in~     an expedited timeframe. This research provides a novel approach to general surgery training~     that has the potential to reduce the amount of time and repetitions required to achieve~     expert laparoscopic skills.~   "
36912|NCT03083470|"~     A Phase 2, randomized, double-blind, dose rising study to determine the safety, tolerability,~     and preliminary efficacy of four concentrations of SOR007 (Uncoated Nanoparticulate~     Paclitaxel) Ointment (SOR007) compared to SOR007 ointment vehicle applied to actinic~     keratosis (AK) lesions on the face twice daily for up to 28 days.~   "
36913|NCT03083457|"~     Low-tidal volume ventilation is arising as a tool to optimize the ventilatory management and~     to improve clinical outcome in patients undergoing general anesthesia for abdominal surgery.~      A recent large randomized controlled trial failed to detect a significant difference between~     two different approaches for ensuring adequate lung recruitment (PEEP=12 cmH2O + scheduled~     recruiting maneuvers vs. PEEP 2 cmH2O) during protective ventilation. Thus, in patients~     undergoing open abdominal surgery and receiving low-tidal volumes, the effects of different~     positive end-expiratory pressure (PEEP) levels and recruiting maneuvers remain to be~     established.~      Design: prospective, cross-over, physiological trial.~      PURPOSE To assess the physiological effects of different PEEP levels with or without~     scheduled recruiting maneuvers in patients undergoing general anesthesia for open abdominal~     surgery and receiving low-tidal volume ventilation.~   "
36914|NCT03083444|"~     To determine if there is an association between Porphyromonas gingivalis infection of dental~     gingiva during primary tooth eruption and thickening of the radial artery intimamedial~     layers. Thickening of these layers in infants could be a promoting factor for later~     development of atherosclerosis.~   "
36915|NCT03083431|"~     Extremely premature infants are at risk of developing a potentially blinding eye disease,~     called retinopathy of prematurity (ROP). Currently available treatment, consisting of laser~     surgery or injection of drugs into the eye balls, may prevent most but not all cases of~     permanent ROP-mediated blindness. Both types of treatment are associated with significant~     costs and side effects. An orally administered drug commonly used to treat hypertension,~     propranolol, may be effective in halting progression of ROP to severe stages, as suggested by~     preliminary data from two small studies. Propranolol has been used for decades not only in~     adult patients but also in newborn infants with heart diseases. Moreover, it has been~     licensed in 2014 for the use in newborn infants with hemangiomas in the European Union,~     Switzerland and the United States. As severe (threshold) ROP is an overall rare disease, the~     effectiveness of propranolol in combating ROP can only be assessed in a large, multicenter~     randomized controlled trial involving hospitals caring for extremely preterm infants of~     diverse origin.~   "
36916|NCT03083418|"~     Chronic Obstructive Pulmonary Disease (COPD) is a common respiratory disease characterized by~     airflow limitation that is progressive and not fully reversible. Patients with acute~     exacerbation of COPD must be hospitalized, as for further increase in airway resistance,~     pulmonary alveolar excessive expansion, diaphragm fatigue and neural respiratory drive. In~     recent years, Pulmonary rehabilitation is recognized as a core component in the comprehensive~     management of COPD, EDP as a means of rehabilitation can alleviate diaphragmatic fatigue,~     improve ventilation function, reduce the neural respiratory drive in patients with COPD~     during hospitalization, but still lack of evidence based medicine. Surface EMGdi can~     accurately evaluate neural respiratory drive, its detection is non-invasive, simple and~     safety .Therefore,Neural respiratory drive by surface EMGdi can be used as an important index~     for evaluating the therapeutic efficacy of AECOPD patients during hospitalization.~      In the present study, about 40 patients with COPD will be recruited as research subjects .And~     the investigators aim to explore the effect of EDP on diaphragmatic function and neural~     respiratory drive in patient with AECOPD.Contrast analysis will be conducted to evaluate the~     effects of EDP on patients with AECOPD, which may provide a reasonable basis for the clinical~     application of EDP to AECOPD patients.~   "
36942|NCT03083067|"~     This is a multi-center, prospective, randomized and standard treatment parallel control~     clinical trial.A total of 764 stable COPD patients according to GOLD will be recruited and~     equally divided into two parallel groups, salvational intervention group (SI group) and~     control group (CT group).On the foundation of basic medicine, inhaled ICS/LABA will be used~     as an intervention drug for patients in SI group on severe air pollution days. It is aimed to~     evaluate whether this novel treatment strategy will decrease the frequency of AECOPD per~     year.~   "
36917|NCT03083405|"~     Sleep apnea is a common and serious health problem in the Polish population. According to~     epidemiological data problem concerns about 7% of the adult population. The most common sleep~     disorder is obstructive sleep apnea (OBS). The consequence of episodes of airway obstruction~     and sleep fragmentation is an inefficient, lack of rest sleep, pathological daytime~     sleepiness, falling asleep involuntarily, awakening with feelings of shortness of breath or~     throttling. The direct consequences of sleep apnea are hypoxia, awakening, increased heart~     rate and increased blood pressure. Frequent complications of obstructive sleep apnea (OSA)~     are hypertension, stroke, cardiac arrhythmia, coronary artery disease, pulmonary hypertension~     and heart failure. An additional problem in patients with sleep apnea is an increased~     incidence of bruxism. It is one of the most common oral parafunctions. Bruxism is a common~     problem; reports of prevalence range from 8-31% in the general population. The most common~     symptoms of bruxism include: hypersensitive teeth, tooth wear, damage to dental restorations~     (e.g. crowns and fillings), damage to periodontal and oral mucosa, masticatory muscle pain~     and headaches. The etiology of bruxism is multifactorial and not fully understood. It can be~     caused by local and general factors. The main general factors may be stress, emotional~     disturbances and mental, neurological, hormonal disorders (eg. Hyperthyroidism),~     gastrointestinal disease, allergies, medications, smoking, sleep disorders and snoring.~     Arousals during the apnea episodes are considered to be a major cause of sleep bruxism. The~     relationship between obstructive sleep apnea and sleep bruxism is still not clearly defined.~     Further research is needed to help explain the relationship between these two phenomena,~     which will enable further therapy in patients with coexisting OSA and sleep bruxism (SB).~   "
36918|NCT03083392|"~     This study is intended to evaluate the efficiency of utilizing dynamic implant valve~     approach (DIVA) system in treating chronic maxillary sinusitis.~   "
36919|NCT03083379|"~     The primary purpose of this study is to determine if there is a significant difference in~     regional distribution of ventilation when comparing eupneic tidal ventilation with Incentive~     Spirometry (I.S.) and EzPAP® lung expansion therapy in healthy adult human subjects.~     Electrical impedance tomography (EIT) will be used to measure regional distribution of~     ventilation during resting tidal ventilation and during lung expansion therapy.~   "
36920|NCT03083366|"~     In the first 3 months after spinal cord injury, patients will be randomized to receive and~     implantable sacral neuromodulator that will stimulate bilateral S3 nerve roots. These~     patients will be compared to those receiving standard neurogenic bladder care. Multiple~     primary and secondary endpoints will be compared based upon urodynamic parameters, quality of~     life measurements, and clinical outcomes.~   "
36921|NCT03083353|"~     The proposed study represents a crucial and important stage in translating basic research to~     strategies for treating nicotine dependence. The investigation addresses an important public~     health issue by testing an intervention - informed by basic research - that may lead to a~     more effective and efficient treatment for smokers. The expected findings should provide~     initial effect size data for the addition of isradipine to an integrated~     psychosocial/behavioral and pharmacological smoking cessation intervention for smokers, and~     thus provide the necessary data for a large-scale follow-up trial.~   "
36922|NCT03083340|"~     The proposed study addresses the potential utility of providing an accessible self-help~     intervention for patients in a medical setting with an estimated diagnosis of MDD.~     Specifically, the study will explore whether a) such an intervention can be effectively~     implemented in a primary care setting and b) patients originally seeking medical attention~     for an orthopedic problem will be willing to seek psychological treatment and, c) improvement~     in depression symptoms will lead to improvement in upper and lower extremity functioning.~   "
36923|NCT03083327|"~     Supplemental prophylactic early parenteral nutrition will be commenced 1 day prior to~     conditioning chemoradiotherapy in patients who are not already malnourished. Supplemental~     parenteral nutrition continues throughout conditioning chemoradiotherapy and stem cell~     transplant.~   "
36924|NCT03083314|"~     This is a pilot study at the National Cancer Institute (INT) of Milan evaluated the~     feasibility of selective axillary dissection (SAD) which preserved the lymphatic drainage of~     the arm. Lymph nodes draining the arm are identified following radiotracer injection and~     lymphoscintigraphy, a technique called axillary reverse mapping (ARM). SAD was found feasible~     in 75% of patients. Furthermore only 9% had BCRL after SAD compared to 33% after axillary~     lymph node dissection (ALND).~   "
36925|NCT03083301|"~     Heart failure is very common and reaches more than 56 million people worldwide. 17 to 45~     percent die in the first year of hospitalization. The most affected populations live in~     Western countries like Europe or the USA.~      It is defined by a set of signs and symptoms such as dyspnea, asthenia, edema or tachycardia~     but must be objectified, preferably by ultrasound. Its basic treatment is based on a~     lifestyle improvement and a reduction of the risk factors (hypertension, dyslipidemia,~     diabetes, ...), as well as an optimal medical treatment based on ACE inhibitors, B-blockers,~     ARA2 (Sartans), spironolactone or digoxin.~      When the optimal treatment is no longer working and that the cardiac desynchronization is~     demonstrated, be it atrio-ventricular, inter-ventricular or intra-ventricular, the patient~     can benefit from a three-probes cardiac resynchronization to resynchronize the two~     ventricles. The classic approach, performed by a cardiologist, is to perform an endovenous~     procedure in order to place the 3 probes under local anesthesia.The first one goes in the~     right atrium, the second one in the right ventricle and the third one goes in the left~     ventricle. It is the placement of this third one that often causes trouble. It is more~     difficult to place since it must pass through the coronary sinus, outside of the heart,~     unlike the first two probes that are placed endocavitary. When the practitioner fails to~     place the probe correctly or obtains inappropriate levels of detection, stimulation, or~     impedance thresholds, a cardiac surgeon must intervene and carry out a mini-thoracotomy.~      The CHU Brugmann Hospital is in favor of a mixed surgical approach. The probes are placed by~     a cardiac surgeon, who first starts by a endo-venous placement under local anesthesia. If~     that approach fails, the local anesthesia can be transformed into general anesthesia at the~     same operative time and a mini-thoracotomy is performed.~      The aim of this study is to evaluate the immediate impact of this surgical management within~     the CHU Brugmann hospital, in patients suffering from cardiac insufficiency despite proper~     medication.The hypothesis is that the mixed surgical approach improves the prognosis of~     cardiac resynchronization.~   "
36926|NCT03083288|"~     Up to 30 evaluable participants with known or suspected breast cancer (BIRADS 5 by imaging)~     will undergo FTT PET/CT imaging before primary surgery or neoadjuvant therapy. Patients~     undergoing neoadjuvant therapy may choose to have a second FTT PET/CT scan after the start of~     therapy (1 days to 3 weeks). FTT PET/CT uptake will be correlated with pathology measures and~     treatment response, in subjects undergoing neoadjuvant therapy~   "
36943|NCT03083054|"~     The main objective of this work is to conduct a clinical study for the development and~     application of a vaccine with autologous dendritic cells submitted to electroporation with~     Wilm's tumor 1 (WT1) messenger ribonucleic acid (mRNA), as an adjuvant treatment of high-risk~     Myelodysplastic Syndromes and Acute Myeloid Leukemia, aiming to delay the progression of the~     disease or its relapse and increase overall and event-free survival.~   "
36948|NCT03082989|"~     Italy is the European country with the minor penetration of FFR as compared to the number of~     percutaneous coronary intervention.~      Accordingly, the Società Italiana di Cardiologia Invasiva (SICI-GISE) conceived and promoted~     a prospective nationwide study to describe the patterns of the use of FFR in an unselected~     real-world population and to to assess the reasons, on clinical decision making, driving~     operators in the use or not of the FFR.~   "
36927|NCT03083275|"~     The age-related loss in skeletal muscle mass is associated with substantial social and~     economic costs as evidenced by impairments in strength, limitations in function, and~     ultimately, physical disability and institutionalization (1-3). Improved knowledge of the~     physiologic mechanisms that mediate impairments in physical functioning is crucial for~     developing effective therapeutic interventions for preserving mobility and independence among~     physically frail adults.~      To date, pharmacodynamic markers that can be used in a clinical trial in mobility-limited~     older adults are limited. Lean body mass measured by dual energy X-ray absorptiometry (DXA)~     is frequently used in early phase clinical development of investigational anabolic drugs.~     Although increase in muscle mass is considered to contribute to increased muscle strength,~     this alone does not completely explain changes in physical performance. Thus, more direct~     pharmacodynamic evidence associated with physical functioning is desired in early phase~     clinical development decision making. Assessments of muscle power and fatigue can address~     this need. The use of such assessments may provide more meaningful information as to the~     pharmacodynamics effects of investigational drugs on muscle parameters.~      This study will serve as a validation study, aiming to 1) examine the effect a 12-week~     resistance program may have on muscle power and fatigue; 2) examine the effect of a 12-week~     resistance exercise program on conventional measures of muscle function; 3) determine the~     relationship between muscle power/fatigue and conventional measures of physical function.~     Data from this study will serve as rationale for potentially including these measures as~     pharmacodynamics markers in studies of novel therapies for skeletal muscle loss and/or~     weakness.~   "
36928|NCT03083262|"~     Dyspareunia, or painful intercourse, is one of the most commonly reported complaints in~     postmenopausal women. One common cause of dyspareunia is vaginal atrophy (VVA), which occurs~     in >50% of postmenopausal women. At the time of menopause, a lack of estrogen thins the~     vaginal mucosa and lessons lubrication, making sex painful. Some women with vaginal atrophy~     will also have high tone pelvic floor dysfunction (HTPFD) (also known as levator spasm).~     Successful treatment of the sexual pain requires treatment of both vaginal atrophy and HTPFD.~      How often vaginal atrophy and HTPFD coexist has not been studied. In fact, the prevalence of~     HTPFD is unknown. This is most likely due to the fact that many clinicians are unaware of its~     existence or how to diagnose or treat it. Also, sexual symptoms tend to be underreported due~     to embarrassment or hesitation to seek care. HTPFD frequently coexists with other conditions~     that cause pain like vaginal atrophy, endometriosis or interstitial cystitis. Treatment~     includes treating both conditions. If only one is treated, then sexual pain is likely to~     continue. There are several available treatments for HTPFD that have been studied including~     physical therapy, botox and intravaginal diazepam.~      This is an area where clinicians may be under treating a condition and limiting the~     possibility of restoring normal sexual function to many women. Treating only vaginal atrophy~     without appropriate evaluation and treatment of HTPFD leaves a cohort of women still~     struggling with sexual pain. With a better understanding of the relationship between HTPFD~     and vaginal atrophy, the investigators hope to bring awareness concerning the importance of~     treating both in restoring normal sexual function.~   "
36929|NCT03083249|"~     Human papillomavirus (HPV) is the most common viral genital tract infection. The majority of~     women and men who are sexually active will be exposed to a strain or strains of the virus.~     While there are hundreds of viral strains, high risk strains are associated cervical and oral~     cancers. According to the Centers for Disease Control (CDC), between 2008 and 2012 there were~     38,793 deaths attributed to HPV related cancers. Vaccinations were created in an attempt to~     prevent infection from the most common high risks strains of HPV. Gardasil/HPV-9 was created~     to help prevent HPV related cancers and warts. The HPV-9 vaccine includes protection from 7~     strains of HPV associated with 74% of HPV related cancers. While Gardasil was approved and~     released in 2006, many men and women have not been vaccinated. A national immunization survey~     in 2011 of teens 13-17 years old noted that only 60% of girls and 40% of boys have received~     at least one vaccination in the series. While complete vaccination series is recommended, a~     recent study found that a single dose of Gardasil when compared to placebo created a higher~     level of serum antibodies in uninfected females.~   "
36930|NCT03083236|"~     The aim of the study is to evaluate the impact of parent based intervention on the language~     of 2 to 3 year old children from socially disadvantaged populations with a clinical diagnosis~     of primary language delay.~   "
36931|NCT03083223|"~     The subjects were placed consecutively in random order in the five different positions by~     drawing lots. Oxygen saturation (SaO2) and vital signs (pulse rate, respiratory rate,~     systolic blood pressure, diastolic blood pressure and body temperature) were measured in each~     position at 10, 25 and 40 minutes.~   "
36932|NCT03083210|"~     Clinical data from uncontrolled retrospective or prospective studies have initially~     demonstrated antiproliferative effects of lanreotide in limited number of patients lanreotide~     Autogel® has recently been approved in more than 40 countries for the treatment of GEP-NET~     patients, this is based on the results of CLARINET study, the largest prospective trial to~     evaluate the antiproliferative effects of lanreotide Autogel® in subjects with nonfunctional~     GEP-NETs. The study enrolled 204 subjects (101 subjects were randomized to lanreotide~     Autogel® group and 103 subjects were randomized to placebo group, came from 14 countries)~     with well or moderately differentiated non-functioning GEP-NETs, including pancreatic and~     gastrointestinal tumors, and defined as having less than 10% of proliferation marker Ki67.~     The study had shown that treatment with lanreotide Autogel® significantly prolonged~     progression-free survival in subjects with GEP-NETs compared to treatment with placebo in the~     primary analysis (median progression-free survival, not reached vs. 18.0 months, P< 0.001 by~     the stratified log-rank test; hazard ratio for progression or death with lanreotide vs.~     placebo, 0.47; 95% confidence interval (CI), 0.30 to 0.73) [5].~      The indication of GEP-NETs granted for lanreotide Autogel® in the USA is for the treatment of~     patients with unresectable, well or moderately differentiated, locally advanced or metastatic~     gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival;~     and in the European Union (EU) is for treatment of grade 1 and a subset of grade 2 (Ki67~     index up to 10%) gastroenteropancreatic neuroendocrine tumors of midgut, pancreatic or~     unknown origin where hindgut sites of origin have been excluded, in adult patients with~     unresectable locally advanced or metastatic disease. The addition of an indication for the~     treatment of patients with GEP-NETs has been approved by more than 15 other authorities~     including in Canada, Australia and some Asian countries, etc.~   "
36944|NCT03083041|"~     This is a multi-center, open-label, Phase II study of intravenous (IV) SHR-1210 at 200mg,q2w~     in combination with Apatinib at two dose levels in subjects with locally advanced or~     metastatic non-small cell lung cancer (NSCLC).~      The study is composed of two parts. Part 1 of the study will determine the safety~     ,tolerability and pharmacokinetics of SHR-1210 in combination with Apatinib.~      Part 2 includes a randomized comparison of Apatinib 250mg/d or 500mg/d plus SHR-1210 .~      Subject's tumors will be screened at baseline for EGFR mutations, EML4-ALK translocation, and~     PD-L1 expression.But positive tumor PD-L1 expression will not be required for enrollment.~   "
36933|NCT03083197|"~     Study type: Randomized Control Treatment Trial~      Study population: Male and female patients with ≥15 years of age and acute scrub typhus~      Duration: 2 years~      Study Design: Prospective, open-label, randomized-controlled treatment trial in patients ≥15~     years old admitted to hospital with acute scrub typhus. Randomization into 3 oral treatment~     arms (each n=59 patients, total n=177): i) 7 days of doxycycline, ii) 3 days of doxycycline,~     and iii) 3 days of azithromycin~      Primary Objective: To evaluate the clinical and microbiological responses in scrub typhus~     patients to three oral treatment regimens: 7 days of doxycycline, 3 days of doxycycline, and~     3 days of azithromycin~      Secondary Objectives:~        1. To perform pharmacokinetic/pharmacodynamics (PK/PD) characterization of the therapeutic~          responses for doxycycline and azithromycin, incl. serial bacterial load measurements.~        2. To define clinical, bacterial, pathophysiological and pharmacological factors associated~          with disease severity, fever-clearance times (FCT), treatment failures and~          relapse/re-infection.~        3. To determine the minimum inhibitory concentrations (MIC) of clinical Orientia~          tsutsugamushi isolates to doxycycline, azithromycin and chloramphenicol, using in vitro~          growth-inhibition assays~        4. To genotype all clinical isolates using whole genome sequencing for comparative~          genomics.~        5. To dissect the natural immune response in scrub typhus, using antigen-specific cellular~          immune and antibody studies, and cytokine profiling~   "
36934|NCT03083184|"~     The purpose of this study is to assessed the efficacy of a combined solution of ethanol (4%)~     and low molecular weight heparins LMWH in preventing tunnelled dialysis catheter infection in~     chronic hemodialysis patients~   "
36935|NCT03083171|"~     In this randomized, double-blind, placebo-controlled study, either a single dose of~     Adrecizumab (0.5, 2.0 or 8.0 mg/kg) or placebo will be administrated to 24 healthy male~     volunteers during experimental endotoxemia.~   "
36936|NCT03083158|"~     Infection and cancer is a major cause of death and morbidity, and may be preventable through~     vaccination. It is not fully understood at the molecular level why some people respond better~     than others to vaccines until now the technology to assess this has not been available. This~     has impaired vaccine development. The overall goal of the Human Vaccines Project is to~     understand the 'rules' of how vaccines work. In this demonstration project the investigators~     will vaccinate healthy adults with hepatitis B vaccine to start to understand better how it~     works, ultimately helping with rational vaccine design in the future.~   "
36937|NCT03083145|"~     The objective of this study is to determine how the protein source and the physical form of~     food consumed at breakfast impact food intake. Research will be conducted by assessing~     feelings of hunger, food preference and blood glucose in healthy adults following the~     ingestion protein-based (animal versus plant) drinks similar calorie and protein content.~   "
36938|NCT03083132|"~     Freezing of gait is a late stage complication of Parkinson's disease in which patients note~     that their feet feel stuck or glued to the ground. This can lead to imbalance and falls and~     the secondary complications that can result from falls such as fractures and~     hospitalizations. While levodopa can help freezing of gait in some patients, it does not help~     in all, and the dose needed to treat freezing may be limited by side effects of the~     medications. Currently there are no treatments targeted towards freezing of gait and the goal~     of this research is to see if Modafinil could be one such drug to help freezing of gait in~     Parkinson's disease.~      20 subjects aged 18 or older with idiopathic Parkinson's disease with freezing of gait will~     be asked to enroll in the study from the patient population in the movement disorders clinic~     at UAMS. Subjects will be assigned randomly 1:1 to an early start and delayed start arm of~     the study. In the early start arm subjects will receive 24 weeks of 50 mg oral daily~     Modafinil while subjects in the delayed start arm will receive 12 weeks of placebo followed~     by 12 weeks of 50 mg oral daily Modafinil. Assessments will be performed prior to initiation~     of medication at the screening visit, as well as at 6 weeks, 12 weeks, 18 weeks and 24 weeks~     of the treatment phase, in addition to 2 weeks after discontinuation of medications. The~     assessments will include questionnaires to determine the frequency and severity of freezing~     of gait, level of mood, anxiety and apathy and quality of life, physical examination and~     tests of cognitive function. Objective assessment of patients walking will be conducted using~     a pressure sensor impregnated mat at each visit.~   "
36939|NCT03083119|"~     In this study, typical cases of coronary heart disease are selected. They will be intervened~     by Xuesaitong soft capsules to investigate efficacy and safety for Coronary Heart disease.~   "
36940|NCT03083093|"~     In this study the investigators will evaluate whether more careful reading (than the current~     standard) of routine computerised tomography pulmonary angiography (CTPA) performed in the~     clinical work-up of suspected (pulmonary embolism (PE) will differentiate patients with acute~     PE from those with more chronic or acute on chronic PE, which could be indicative of the~     presence of chronic thromboembolic pulmonary hypertension (CTEPH)~   "
36941|NCT03083080|"~     Traditionally, video-assisted thoracic surgery is performed under general anesthesia with~     double-lumen endotracheal tube. However, the complications associated with this large tube as~     well as inhalation anesthetics are frequently reported. Therefore, currently there is a trend~     toward non-intubated anesthesia methods for video-assisted thoracic surgery, which includes~     thoracic epidural block, peripheral nerve block, local anesthesia, local combined with~     peripheral nerve block, etc. Thoracic epidural block demands a high technique, but still~     risks catastrophic neurological complications in case of accidental dural puncture. Local~     anesthesia, perhaps more straightforward, however may need supplemental analgesia during~     incision, which will inevitably interrupt surgery and negatively affect the patients. This~     study aims to apply ultrasound guidance during local anesthetic injection for local~     anesthesia-based video assisted thoracic surgery, which helps inject the local anesthetic~     into the key intercostal nerve plane to provide more specific and precise blockade, thus~     avoiding the chance of blind injection. At the same time, ultrasound guidance has the~     potential to reduce the risk of systemic toxicity, prolong the duration of analgesia~     postoperatively, and facilitates postoperative recovery.~   "
36945|NCT03083028|"~     This study will determine whether operative management confers improved short and long−term~     outcomes for patients with isolated AO type 44−B1 distal fibula fractures when compared with~     non−operative management.~   "
36946|NCT03083015|"~     This study compared the efficiency of pulp revascularization and MTA apexification in the~     treatment of patients with necrotic immature anterior teeth.~   "
36949|NCT03082976|"~     A prospective, multi-centre, epidemiological observational study designed to evaluate the~     prevalence of BRCA1 and BRCA2 (BReast CAncer gene) mutations in current and newly diagnosed~     ovarian cancer patients across different countries in the Gulf region. This study will also~     describe the epidemiological features for the disease for the enrolled patients.~   "
36950|NCT03082963|"~     The overall goal of this project is to test the feasibility of performing real-time~     electrogram morphology recurrence (EMR) mapping in patients with persistent atrial~     fibrillation (AF) to locate areas of high electrogram morphology recurrence rate. The~     Investigator believe that the EMR mapping can be integrated into cardiac mapping and used to~     identify potential sites for ablation. Furthermore, this study could help demonstrate the~     efficacy of this technology's ability to terminate or slow AF.~      The Investigator will test this technology on ten subjects undergoing a second ablation~     procedure. The Investigator will map the AF utilizing the EMR to indicate locations of stable~     activity and ablate the area. The Investigator believes that the study could produce acute AF~     termination or AF cycle length slowing. In addition to testing the real-time electrogram~     morphology recurrence mapping, the study would also like to determine the acute effects of~     radiofrequency ablation of areas of high recurrence rates and determine long term freedom~     from AF following ablation of areas of high recurrence rates.~   "
36951|NCT03082950|"~     HPV infections may be responsible for different types of cancer in females. Primary Goal of~     the study was to identify the prevalence of an hpv affiliation in retrospective-prospective~     analysed cohort of patients who suffer from vulvar cancer and their preinvasive lesions.~   "
36952|NCT03082937|"~     The primary objectives of the study are to assess the mass balance recovery after a single~     dose of carbon-14 [14C]-A4250 as a capsule and to provide plasma, urine and faecal samples~     for metabolite profiling and structural identification in healthy male subjects.~   "
36953|NCT03082924|"~     Pulmonary rehabilitation is recognized as a core component of the management of individuals~     with chronic obstructive respiratory disease, which has become first-line treatment besides~     drug therapy. However, in the current clinical evaluation system of pulmonary rehabilitation,~     there is still a lack of simple, objective index,which can be monitored at any time.Neural~     respiratory drive , as an important physiological index, is closely related to the symptoms~     and the severity of the disease. It may be a sensitive indicator to evaluate the~     effectiveness of pulmonary rehabilitation. Surface EMGdi can accurately evaluate neural~     respiratory drive , its detection is non-invasive, simple and safety . In recent years, with~     the development of signal detection and analysis technology, EMG recording is more stable,~     but as the related research samples were low, surface diaphragm EMG has not yet the~     establishment of standardization. Therefore, based on the previous work, the project was~     carried out in a multicenter randomized controlled study,in which the stable stage of COPD~     patients were included in different ways of pulmonary rehabilitation training, a~     comprehensive clinical assessment will be conducted before and after training. Compared with~     the traditional evaluation methods and standard esophageal diaphragmatic electromyography,~     surface EMGdi detect the changes of neural respiratory drive in patients with COPD,that can~     help to explore the application value of surface EMGdi in the assessment of chronic~     obstructive pulmonary disease with pulmonary rehabilitation, to provide a basis for the~     promotion of the diaphragm and the optimization of pulmonary rehabilitation program.~   "
36954|NCT03082911|"~     Objective: To assess the effectiveness of a brief telephone intervention added to an post~     invitation letter in the participation rate to a colorectal cancer screening program.~      Methods: Randomized controlled trial. This study is framed inside the colorectal cancer~     screening program of Catalonia, concretely in the region of Vallès Occidental. This program~     is directed to men and women from 50 to 69 years. The screening test used is the fecal~     immunological test (FIT) that is offered every 2 years. If the screening test is positive, a~     colonoscopy with sedation is offered as a diagnostic test.~   "
36955|NCT03082898|"~     The proposed study is intended to inform the hypotheses that (1) regular dosing of~     exoskeleton walking will provide health benefits to non-ambulatory and poorly-ambulatory~     individuals with SCI, including decreased pain and spasticity, improvements in bowel and~     bladder function, decreased body-mass index (BMI), enhanced well-being; (2) regular dosing of~     exoskeleton walking will facilitate neurological or functional recovery in some individuals~     with SCI, particularly those with incomplete injuries; and (3) the level of mobility enabled~     by a lower limb exoskeleton is commensurate with the walking speeds, distances, and surfaces~     required for community ambulation.~   "
36956|NCT03082885|"~     A randomized controlled trial to evaluate efficacy and safety of Thymosin-α1 administration~     in patients with HBV-related Acute-on-chronic liver failure.~   "
36957|NCT03082872|"~     To introduce a novel external-fixation technique using the combination of K-wires and cement,~     and the objective of this report is also to compare the technique with conventional open~     transfixion pinning.~   "
36958|NCT03082859|"~     Exercise is considered one of the three cornerstones of type 2 diabetes (T2D) care programmes~     (together with diet and medication), yet the majority of individuals with T2D do not achieve~     the minimum recommended levels of physical activity. Two of the key barriers to exercise~     appear to be a 'lack of time' and the high levels of perceived exertion and fatigue. At~     Ulster University, it has recently been demonstrated that a modified high-intensity interval~     training (HIT) intervention, consisting of 10-min of low-intensity cycling interspersed with~     two 20-s 'all-out' sprints (reduced-exertion HIT; REHIT), was effective at improving insulin~     sensitivity in sedentary men over six weeks. Importantly, these benefits were observed~     despite the very low time commitment (just 10-min per session) and relatively low ratings of~     perceived exertion ('somewhat hard'). As REHIT is associated with substantial muscle glycogen~     breakdown, we hypothesise that this exercise mode may also acutely improve glycaemic control~     in patients with T2D. This study will:~        1. Examine the acute impact of REHIT, compared with a no-exercise control, on 24-hour~          glycaemic control under dietary-controlled but otherwise 'free-living' conditions using~          continuous glucose monitoring.~        2. Compare the effects of REHIT with currently recommended levels of aerobic exercise and a~          previously recommended HIT model, both of which have been shown to improve 24-hour~          glycaemic control in T2D.~        3. Collect information on individual's perceptions of each exercise mode through measures~          of affect, motivation, perceived exertion, fatigue, enjoyment and attentional focus.~   "
36959|NCT03082846|"~     Postoperative conventional radiation at 60 Gy/30f is currently still considered the standard~     radiotherapy mode for high-grade gliomas; however, the efficacy is still unsatisfactory.~     Studies in recent years have shown that hypofractionated simultaneous integrated~     boost-intensity modulated radiation therapy (SIB-IMRT) has certain survival benefits over~     other fractionation methods; but, the best hypofractionation mode and its efficacy have not~     been confirmed. The purpose of this study is to investigate the maximum tolerated dose (MTD)~     of hypofractionated SIB-IMRT with stepwise escalating of doses combined with temozolomide~     (TMZ) for the treatment of malignant gliomas.~   "
36960|NCT03082833|"~     Phase II trial of AZD2014 in TSC1/2 mutated or TSC1/2 null GC patients as second-line~     chemotherapy~   "
36961|NCT03082820|"~     The study examines pain-related evoked potentials (PREP) in patients with peripheral nerve~     injuries. Since previous studies found altered latencies and amplitudes of PREP in~     generalized polyneuropathies, e. g. HIV-polyneuropathy and fibromyalgia, this study~     investigates if these alterations are detectable in unilateral peripheral nerve injuries as~     well.~   "
36962|NCT03082807|"~     The present study aimed to determine the effects of negative-calorie diet supplemented with~     exercise, on weight loss and lipid profile, and to compare its efficiency with low-calorie~     diet with exercise among elderly adult men with abnormal weight gain.~   "
36963|NCT03082794|"~     Negative-calorie diet is among the popular dieting guides for weight loss; however, there is~     still little knowledge about this method. The present study aimed to determine the effects of~     negative-calorie diet on weight loss and lipid profile, and to compare its efficiency with~     low-calorie diet in men.~   "
36964|NCT03082781|"~     The present study aimed to determine the effects of negative-calorie diet supplemented with~     exercise, on weight loss and lipid profile, and to compare its efficiency with low-calorie~     diet with exercise among elderly adult women with abnormal weight gain.~   "
36965|NCT03082768|"~     The overall goal of this protocol is to evaluate [18F]MNI-968 (aka PF-06730110) as a D1~     receptor targeted radiopharmaceutical.~   "
36966|NCT03082755|"~     Nighttime agitation in persons with Alzheimer's disease causes patient suffering, distresses~     caregivers, and often results in prescriptions for harmful antipsychotics. Effective~     treatments are lacking because of limited knowledge of the etiology of nighttime agitation.~     The investigators propose a clinical trial to better elucidate whether a sleep disorder,~     restless legs syndrome, may be a mechanism for nighttime agitation, and if treatment with~     gabapentin enacarbil (Horizant®) reduces nighttime agitation, improves sleep, reduces~     restless legs syndrome behaviors, and reduces antipsychotic medications.~   "
36967|NCT03082742|"~     Chronic kidney disease (CKD) patients often have associated systemic hypertension due to~     volume retention, as one of the mechanisms, therefore the use of diuretics is widespread in~     this population. One of the major complications of CKD is mineral and bone metabolism~     disorder (CKD-MBD), which include changes in the levels of calcium, phosphorus, vitamin D~     deficiency, increased circulating levels of fibroblast growth factor (FGF-23) and parathyroid~     hormone (PTH). These alterations are responsible for fractures, cardiovascular disease and~     mortality among patients with CKD. According to diuretic mechanism of action, sometimes~     increasing serum calcium (in the case of furosemide), sometimes decreasing it (in the case of~     thiazide), it is expected that the serum calcium may be altered, even within the range of~     normality, with consequent impact on the levels of PTH. Although most studies have shown that~     the use of thiazide diuretics decreases the risk of fractures, some showed the opposite.~     Similarly, although most studies have shown increased risk of fracture in association to loop~     diuretics use, some have failed in demonstrated this outcome. Only one study, a cohort study~     in a population of CKD, showed that furosemide was directly related to increased calciuria~     and PTH levels and the use of thiazide, in turn, showed completely opposite effect. However,~     certain issues are still not completely solved, for example, the interference of renal~     function itself on calciuria. It is possible that calciuria is not a so simple explanation~     that justifies the PTH levels changes, as no correlation was seen between calciuria and PTH~     levels. Better understanding of the exact relationship between the use of diuretics and the~     impact on CKD-MBD may be an alternative intervention, easily accessible and relatively~     inexpensive. The purpose of this study is to evaluate the impact of diuretic, specifically~     hydrochlorothiazide and furosemide, on bone architecture and mineral metabolism.~   "
36968|NCT03082729|"~     The purpose of the VIP-A study is to determine the effect of apremilast on aortic vascular~     inflammation, cardiometabolic biomarkers and body composition in patients with~     moderate-severe psoriasis.~   "
36969|NCT03082716|"~     Cardioplegic arrest is an essential part of cardiac surgery which aims to allow myocardial~     preservation and minimise myocardial swelling ,while providing a motionless and bloodless~     field ,.Blood cardioplegia has proven its efficacy for several decades and surgeons are still~     preferring to use it for myocardial protection of paediatric cardiac surgery ,although it is~     thought to be more time consuming since it is given with interrupted doses, . Even when~     advancement has came along the field of myocardial protection and cardioplegia solutions with~     the introduction of Bretschneider Histidine-Tryptophan-Ketoglutarate solution ,custodiol ,in~     1970 ,which is given as a single dose and believed to be convenient, simple to deliver , and~     less time consuming . Many Surgeons haven't change their practice possibly due to paucity of~     studies comparing cardioplegia solutions in paediatric cardiac surgery and conflicting~     reports regarding the superiority of different cardioplegia solution.The investigators aim to~     provide evidence that will help paediatric cardiac surgeons to choose the optimal solution~     for their practice .~   "
36970|NCT03082703|"~     This randomized study aims at examining the impact of text messaging in the management of~     non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH), a disease~     frequently associated with obesity and varying components of metabolic syndrome including~     diabetes mellitus, hypertension, and dyslipidemia. With rising incidence of obesity in the~     US, NAFLD and NASH are rapidly increasing with currently the second etiology for liver~     transplantation in the US. The objectives of this protocol are to a) prospectively enroll~     patients with NAFLD and NASH; b) randomize them to receiving text messaging to help manage~     obesity and other components od metabolic syndrome in addition to standard clinical care or~     receiving only standard clinical care; and c) follow up these patients at the end of 3 months~     period for weight loss, blood pressure control, HBA1c, and liver enzymes. The immediate aim~     of this protocol is to develop the pilot data on the usefulness of text messaging in the~     management of NAFLD and NASH. The long-term goals of this research are to establish text~     messaging as a beneficial intervention in the management of weight loss and control of risk~     factors of NAFLD and improve outcomes of these patients with NAFLD and NASH.~   "
37047|NCT03081702|"~     This is a phase I/II study to find the highest dose of hydroxychloroquine that can be given~     safely with itraconazole in patients with advanced platinum-resistant epithelial ovarian~     cancer. The study will also determine the safety, tolerability, and initially determine~     whether the combination is useful in the treatment of patients with advanced~     platinum-resistant epithelial ovarian cancer.~   "
36971|NCT03082690|"~     The purpose of this study is describe the safety and single-dose pharmacokinetics of~     rectally-administered IQP (ImQuest Pharmaceuticals)-0528 (DuoGel) in plasma, rectal tissue~     biopsies, vaginal tissue biopsies, rectal fluid and cervicovaginal fluid as well as to assess~     the luminal distribution of IQP-0528 in the rectum. Sixteen healthy volunteers will receive a~     single rectal dose of DuoGel, followed by blood, tissue and fluid sampling over the following~     72 hours.~   "
36972|NCT03082677|"~     This is a single arm open label phase 2 study evaluating the potential effect of ixazomib on~     the prevention of recurrent or late acute graft-versus-host disease (GVHD) and chronic GVHD~     at 1-year following reduced intensity (RI) or non-myeloablative (NMA) allogeneic~     hematopoietic stem cell transplantation (HSCT) for the treatment of hematologic malignancies.~   "
36973|NCT03082664|"~     This is a randomized controlled trial. Patients with a condition that increases their risk of~     a wound complication will be approached for inclusion in the trial. Each participant agreeing~     to study inclusion will be randomized to either suture alone or to closure of their skin~     incision with suture and then with prophylactic placement of a wound vac (PICO).~   "
36974|NCT03082651|"~     The proposed study will investigate the effect of alternating footwear model and workout-type~     on the occurrence of running-related pain. To achieve this goal participants will be randomly~     assigned into one of four different groups who will perform: 1) the same workout throughout a~     week in the same running shoe model, 2) alternating workout-types throughout the week in the~     same shoe model, 3) the same workout throughout a week in alternating shoe models, and 4)~     alternating workouts in alternating shoes. Participants will be characterized based on body~     alignment, strength, injury and training history. Pain and injury status will be monitored.~   "
36975|NCT03082638|"~     The scientists working on this study want to use blood samples to identify components in~     blood, such as protein, lipids and their breakdown products to determine if they can be used~     for diagnosing Gulf War Illness (GWI). An additional goal is to examine the relationship of~     changes in these markers with the exposures and symptoms associated with GWI.~      The Scientists will also prepare RNA and DNA from the blood samples for genetic analyses of~     certain proteins known to increase the risk for GWI. This information will be one of the~     factors included in the analysis of results from the protein studies.~   "
36976|NCT03082625|"~     Oral magnesium supplementation has been widely used in the treatment of muscle cramps. Muscle~     cramps are common in dialysis patients but are not satisfactorily prevented by oral~     magnesium. Transdermal administration of magnesium has been promoted as a potential treatment~     for muscle cramps but this has not been investigated rigorously. We aim to evaluate the~     effectiveness of transdermal magnesium supplementation in reducing cramp frequency and~     severity. We will recruit current haemodialysis patients who suffer from muscle cramps into a~     randomised, placebo-controlled, cross-over design trial. Each intervention period will last 8~     weeks with a 4-week washout period in between. We will measure muscle cramp frequency,~     duration and severity as the primary outcomes.~   "
36977|NCT03082612|"~     The purpose of this study is to evaluate the feasibility and acceptability of an intervention~     designed to reduce psychological distress among African Americans during treatment for~     cancer. This knowledge will inform a larger test of an intervention tailored to decrease the~     psychological distress experienced among African Americans diagnosed with late-stage cancers.~     Study participants will take part in 4 data collection sessions and also asked to view and~     provide feedback on audio- or video recorded vignettes of African Americans use of hymns to~     reduce psychological distress during the diagnosis and treatment for cancer. Participants~     will also be asked to complete interviews at the 4 time periods which will include~     open-ended, semi-structured interviews, and structured interview questions. This study~     addresses the need to understand the ways in which narrated messages of hope through hymns~     and African American religious song in particular, reduce psychological distress.~   "
36978|NCT03082599|"~     In July 2016, the FDA approved an extended depth of focus (EDOF) IOL (Tecnis Symfony, Abbott~     Medical Optics) helping to improve the sharpness of vision at near, intermediate and far~     distances reducing the need of glasses after cataract surgery. It is available in both a~     non-toric version and a toric version for patients with astigmatism. The difference between~     this lens and the multifocal (MIOL) counterpart is that the EDOF, similarly to a monofocal~     IOL, has one focal point (elongated in the EDOF) while the multifocals have 2 focal points;~     therefore, having less of a halo and glare problem. Pivotal trial results where Symfony was~     compared to a monofocal IOL showed similar uncorrected distance visual acuity (UCDVA), better~     intermediate (77% vs. 34% 20/25 uncorrected intermediate visual acuity - UCIVA) and near~     vision (Symfony patients were able to read two additional, progressively smaller lines~     compared to the monofocal IOL).A One potential disadvantage of the EDOF IOL compared to a~     MIOL is the visual performance at near.B One option to deal with this potential shortcoming~     is to set the non-dominant eye for a small residual myopic error (-0.50 D)C what is referred~     to as nano-vision or mini mono-vision.~   "
36979|NCT03082586|"~     The aim of this trial is to find the maximum tolerable dose of radiation that can be~     delivered combined with chemotherapy (DDP & Paclitaxel) in patients with inoperable or~     medically unresectable esophageal cancer.~   "
36980|NCT03082573|"~     This study will examine the clinical response, cytokine expression and joint imaging after~     addition of Acthar Gel. The hypothesis is that H.P. Acthar Gel is both safe and effective for~     treatment of patients with refractory rheumatoid arthritis (RA) and has different mechanism~     of action than steroids and other DMARDs.~   "
36981|NCT03082560|"~     The study's Primary Objective is to design and validate a grading system for objective and~     accurate assessment of lichen planopilaris.~      Secondary Objectives:~        -  To assess change in symptoms such as pain and itch using a Numeric Rating Scale(NRS)~          scores and quality of life using the Dermatology Life Quality Index (DLQI) scores~        -  To correlate this grading system with patient skin biopsies evaluating disease activity~          on a microscopic level~        -  To correlate this grading system with digital global photography and trichoscopy~   "
36982|NCT03082547|"~     To study the clinical characteristics of headache patients with pericranial myofascial~     trigger points(MTrPs),and to explore the possible pathogenesis of MTrPs,investigators hope to~     find the possible electrical biomarkers for clinical diagnosis and treatment, and to improve~     the effect of headache treatment.~   "
36983|NCT03082534|"~     This is a prospective, multi-center, open-label, non-randomized, multi-arm phase II trial to~     evaluate the efficacy of combination therapy with pembrolizumab and cetuximab for patients~     with recurrent/metastatic HNSCC. There will be four patient cohorts, including a PD-1/PD-L1~     inhibitor-naïve, cetuximab-naïve arm (Cohort 1), a PD-1/PD-L1 inhibitor-refractory,~     cetuximab-naïve arm (Cohort 2), a PD-1/PD-L1 inhibitor-refractory, cetuximab-refractory arm~     (Cohort 3), and a cutaneous HNSCC arm (Cohort 4). A total of 83 patients (33 in Cohort 1, 25~     in Cohort 2, 15 in Cohort 3, and 10 in Cohort 4) will be eligible to enroll. Patients will be~     enrolled at 4 sites: UC San Diego Moores Cancer Center, UC Los Angeles Jonsson Comprehensive~     Cancer Center, University of Michigan Comprehensive Cancer Center, and University of~     Washington Siteman Cancer Center.~   "
36984|NCT03082521|"~     This PAR (participatory action research) study to improve antibiotic prescribing quality in a~     GPC (general practitioner cooperative) during OOH-care (out-of-hours-care) uses a mixed~     methods approach using qualitative as well as quantitative techniques. In a first exploratory~     phase we will work on partnership development and mapping the existing issues. In a second~     phase the focus will be on facilitating change and implementing interventions through PDSA~     (plan do study act) cycles. In a third phase outcomes on prescribing quality during and~     outside office hours will be evaluated. Equally important is the process evaluation and~     theory building on improving antibiotic prescribing through PAR.~   "
36985|NCT03082508|"~     AUGMENT-HF II is a study to evaluate the efficacy and safety of the Algisyl device. The~     purpose of this study is to investigate Algisyl employed as a method of left ventricular~     augmentation and restoration in patients with dilated cardiomyopathy.~      Algisyl will be injected into the myocardium under direct visualization during the surgical~     procedure. Structural abnormalities in the heart are known to play a central role in HF, and~     clinical evidence supports a strong causal relationship between cardiac chamber dilation and~     heart failure. Because dilation, and not contractile dysfunction, appears to be responsible~     for the severity of the disease, the mitigation or prevention of the deleterious structural~     abnormalities of the left ventricle appears to be an important therapeutic target for~     patients with this life threatening illness.~      Hence, a therapy that specifically reduces LV wall stress, targets LV dilatation and LV~     remodeling may offer an important new alternative in the treatment of heart failure. Algisyl~     is being investigated based on evidence that suggests an ability of the implants to reduce~     wall stress, reshape the LV chamber and reduce the LV chamber size as well as prevent the~     progressive ventricular dilation and remodeling associated with HF.~      The physiologic response to progressive exercise using direct measures of ventilation and gas~     exchange via the cardiopulmonary exercise test is an important diagnostic tool in the~     management of the patient with HF, quantifying responses to therapy, and as a reliable~     prognostic utility for predicting outcomes in patients with HF.~      Numerous studies have established the strong association of peak VO2 with mortality and~     morbidity risk in HF. Peak VO2 conceptually is considered an overall global marker of~     cardiopulmonary health and is a reflection of the degree of impairment in ventricular~     function ( the heart's pumping capacity), oxygen delivery and oxygen utilization.~      Hence, employing the change in peak VO2 as a primary endpoint in this clinical study provides~     a strong objective measure that can be interpreted in independent blinded fashion, to~     evaluate the result of the therapeutic intervention and provide an equally strong assessment~     of the prognostic implications for patients in the study.~      This clinical evaluation is intended to provide confirmatory evidence of the effectiveness~     and safety of the device Algisyl in patients with advanced heart failure.~   "
36986|NCT03082495|"~     This study is designed to investigate if aerobic exercise during and after neoadjuvant~     chemoradiotherapy (NACRT) can improve outcomes for rectal cancer patients.~      Rectal cancer patients will be randomly assigned to aerobic exercise or usual care. Patients~     in the aerobic exercise group will be asked to complete 3 supervised high-intensity aerobic~     interval training (HIT) session/week during NACRT and ≥ 150 minutes/week of unsupervised~     aerobic exercise after NACRT.~      Primary hypothesis: aerobic exercise during and after NACRT, compare to usual care, will~     result in significantly better cardiorespiratory fitness.~   "
36987|NCT03082482|"~     The proposed pilot study seeks to address the smoking treatment needs of people living with~     HIV/AIDS (PLWHA) by evaluating the feasibility and preliminary efficacy of a smartphone~     delivered automated video-assisted smoking treatment (AVAST). AVAST will enable smoking~     cessation treatment content to be presented with voice/audio, images, videos, and text in an~     interactive, structured format anytime and anywhere. This automated treatment approach is~     designed to enhance treatment engagement and facilitate abstinence from smoking among PLWHA.~     Participants will be recruited from the University of Oklahoma Health Sciences Center (OUHSC)~     clinics providing care to HIV+ individuals (e.g., the Infectious Diseases Institute).~   "
36988|NCT03082469|"~     Severe acute pancreatitis (SAP) has a mortality of up to 42%. The outcome of SAP is related~     to the development of SIRS and consecutive organ failures. Due to the lack of a causative~     therapy except the removal of bile duct stones, therapy is predominantly symptomatic.~      With regard to a marked inflammatory response (cytokine storm) during the early phase of~     SAP extracorporeal cytokine removal is a promising therapeutic approach.~      This prospective case control study investigates the impact of early extracorporeal cytokine~     adsorption with the CytoSorb®-device on haemodynamics (primary endpoint) and several~     secondary outcomes.~   "
36989|NCT03082456|"~     The molecular breast imaging (MBI) is a potential modality to screen breast cancer. In this~     study, we compare and evaluate the recall rate/diagnostic efficiency of MBI, mammography and~     breast sonography, and aim to determine best ways of breast cancer screening.~   "
36990|NCT03082443|"~     To evaluate the effectiveness of a group intervention in the nutritional profile, in the~     stress and in the quality of life of patients in cardiopulmonary rehabilitation. Method:~     Randomized clinical trial using a semi-structured interview, sociodemographic and~     anthropometric data collection, with 164 participants divided into a control group and~     intervention group, the Food Frequency Questionnaire, the Lipp Adult Stress Symptom Inventory~     (ISSL) ) And the SF-12 Quality of Life Assessment Questionnaire. To verify the difference in~     nutritional profile, stress levels and quality of life between the groups, the chi-square~     test will be used for categorical variables and within each group the comparison between the~     moments will be through the MC Nemar test. In the quantitative variables the evaluation of~     the interaction between group and time will be through Variance Analysis using the design in~     Repeated Measures. Considering a significance level p <0.05. Expected Results: It is believed~     that psychological and nutritional intervention in patients participating in therapeutic~     groups helps them to elaborate questions regarding the difficulties of coping with the~     disease in the daily routine and to understand the importance of lifestyle care and healthy~     habits.~   "
36991|NCT03082430|"~     This monocentric protocol is designed to evaluate the efficacy of therapeutic management of~     symptomatic knee osteoarthritis (resistant to medical first-line treatment) by~     intra-articular injection of autologous PRP prepared in the same procedure and using a~     dedicated CE marked medical device and a validated and reproducible method of preparation~   "
39921|NCT03044171|"~     To investigate the effects of desensitizing agents on the dental bleaching process, testing~     the hypothesis that they may prevent dental sensitivity.~   "
36992|NCT03082417|"~     The PAINFREE (Improving PAIN control following FRactures; towards an Elder-friendly Emergency~     department) Initiative is a patient-centered multifaceted intervention which aims to improve~     pain management in patients 75 years and older presenting with a fracture at 7 Emergency~     Department of participating Montreal hospitals:~        1. Montreal General Hospital~        2. Royal Victoria Hospital~        3. Ste Mary's Hospital~        4. Hôpital de Verdun~        5. Hôpital du Sacré-Coeur de Montréal~        6. Jewish General Hospital~        7. Lakeshore General Hospital~   "
36993|NCT03082404|"~     Chronic kidney disease is a renal injury and progressive and irreversible loss of kidney~     function and in its most advanced stage is called chronic renal failure. Although~     hemodialysis replace some kidney function, patients suffer some alterations characterized by~     uremic syndrome typically expressed by: motor neuropathy and/ or autonomic neuropathy,~     cardiac or musculoskeletal myopathies, peripheral vascular changes, among others. Thereby,~     the the adoption of physical exercise should be encouraged. However, it is known that the~     ability to exercise the subject in hemodialysis is low and they present weakness of the~     peripheral muscular system, including inspiratory muscles. The aim of this study is to assess~     the effects of inspiratory muscle training (IMT) on ventilatory muscle strength and~     functional capacity of patients with chronic kidney disease in hemodialysis. For this the~     following assessments will be performed before and after intervention: six-minute walk test~     to functional capacity; Kidney Disease and Quality of Life - Short Form questionnaire for~     quality of life; flow-mediated dilatation to endothelial function; sit-to-stand test for~     proximal strength of lower limbs. The subjects will be randomized into two groups, IMTG~     (inspiratory muscle training group) and CG (control group). The first will receive the IMT,~     for five weeks, three times a week, during hemodialysis session and the patients will be~     oriented to realize more three days at home. The control group only will be evaluated and~     re-evaluated. Expected results at the end of the protocol with IMT are: increased inspiratory~     muscle strength; longest distance covered on the six-minute walk test; improved quality of~     life; increased muscle strength of the lower limbs; improved endothelial function.~   "
36994|NCT03082391|"~     The purpose of this study is to determine if mesh weight has an impact on postoperative pain,~     ventral hernia recurrence, incidence of deep wound infection, and overall quality of life~     following ventral hernia repair with mesh.~   "
36995|NCT03082378|"~     Recurrence and metastases after microwave ablation(MWA) of hepatocellular carcinoma(HCC) are~     the major factors that influence the survival. Obesity has been reported was significantly~     correlated with increased risk of developing HCC.~      In this study, we will analysis the association of multiple obesity index(waist~     circumference,waist-hip ratio and body mass index) with the prognosis of HCC treated by MWA.~   "
36996|NCT03082365|"~     The patients with chronic kidney disease suffer from many oral problems affecting the quality~     of life. The aim of our study is to assess their oral health to provide the proper management~     and increase their awareness~   "
36997|NCT03082352|"~     The purpose of the study is to compare the bioavailability of a generic product of metoprolol~     with that of a reference product when administered to healthy volunteers under fasting~     conditions. The test product is BF-Metoprolol Tablets 100mg manufactured by Bright Future~     Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited and the~     reference product is Betaloc Tablet 100mg. The plasma kinetic data of metoprolol obtained~     from two formulations will be used to access the interchangeability of the products.~   "
36998|NCT03082339|"~     Scientific and clinical data report about shortening of QTc-interval in patients treated with~     cortisone. Peal et al. analyzed chemical suppression of long QT syndrome (Type 2) in an in~     vivo zebrafish model. Their study revealed that flurandrenolide reproducibly suppressed the~     long QT phenotype via the glucocorticoid signaling pathway. In contrast to treatment with~     dexamethasone and testosterone, treatment with pure mineralocorticoid deoxycorticosterone~     acetate did not suppress long QT phenotype. Knockdown of the glucocorticoid receptor or,~     conversely, of the androgen receptor showed that flurandrenolide acting through the~     glucocorticoid receptor shortens ventricular action potentials. The mechanism is distinct~     from trafficking rescue of the defective zebrafish-ERG channel. The authors discuss that a~     drug normalizing repolarization would be a novel therapeutic tool in long QT syndrome and~     conclude that glucocorticoids could be expected to aid in the acute management of patients~     with long QT syndrome, e.g. in episodes of arrhythmic storm. In addition, corticoid induced~     normalization of the QT interval is reported in a patient with drug-induced prolongation of~     the QTc interval. Brostoff et al. report on a patient suffering from mucocutaneous~     leishmaniasis treated with sodium stibogluconate. During therapy, the QTc interval prolonged~     and returned to normal within 4 days after starting glucocorticoid therapy with prednisolone~     20 mg twice daily.~      Interrogation of the study:~        -  shortens cortisone the QTc-interval?~        -  how long is the interval until shortening of QTc-interval?~        -  is the effect prolonged?~        -  is the effect dose dependend?~   "
36999|NCT03082326|"~     Shock is a common condition in critical care unit (ICU). It is extremely important that the~     patient accepts early goal-directed therapy (EGDT) treatment in the early stage of shock.~     However, several studies failed to demonstrate that the well used variables such as CVP and~     others could direct to a better treatment. In recent years, critical care ultrasound (CCUS)~     has been respected as a reliable noninvasive tool and widely used in ICU practice. With CCUS~     the investigators can accurately acquired the detailed information of the characteristic of~     the hemodynamics and lung pathology (the systole and diastole function, volume status, valve~     insufficiency, lung, edema, consolidation, and pleural effusion, etc.). To the investigators~     knowledge, there is no study investigating the epidemic of such ultrasonic variables and its~     value to predict to outcome. The aim of this study is to investigate the epidemic and the~     prognostic value of CCUS Based Characteristic of Hemodynamic and Lung pathology in Early~     Stage of Shock in patients admitted in ICU.~   "
37000|NCT03082313|"~     The objective is to pilot test the effectiveness of an evidence-based intervention to promote~     positive neurodevelopmental outcomes in infants at risk for developmental delay. The~     intervention promotes movement experience from 3 months to sitting onset.~   "
37303|NCT03078361|"~     The purpose of this study is to conduct 4 focus groups and recruit for 12 participants per~     focus group to explore community members' views about colorectal cancer screening (CRCS)~     processes and perceived benefits and impediments, what information they believe should be~     communicated, communication preferences (style, tone) and perceptions of screenings.~   "
37001|NCT03082300|"~     The objective of this study is to evaluate the bioequivalence of a tablet formulation versus~     a capsule formulation of ASP8273 following a single dose under fasted condition in subjects~     with non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR)~     mutations. The study will also evaluate the safety and tolerability of a tablet formulation~     as a single dose and a capsule formulation as a single and multiple dose of ASP8273 in~     subjects with NSCLC harboring EGFR mutations.~   "
37002|NCT03082287|"~     The ALPCO Calprotectin ELISA is an in vitro diagnostic test intended to quantitatively~     measure concentrations of fecal calprotectin in human stool samples. Calprotectin is a~     protein biomarker of mucosal inflammation. Measurement of calprotectin can aid in the~     diagnosis of Inflammatory Bowel Diseases (IBD), specifically Crohn's Disease (CD) and~     Ulcerative Colitis (UC), as well as aid in the differentiation of IBD from Irritable Bowel~     Syndrome (IBS) when used in conjunction with other diagnostic testing and the total clinical~     picture. This study will estimate the predictive values of a negative (NPV) and positive~     (PPV) test by utilizing the assay outcomes of the ALPCO Calprotectin ELISA.~   "
37003|NCT03082274|"~     Target enrollment is 1000 prospectively enrolled subjects with an initial negative biopsy~     scheduled for repeat biopsy.~      Subjects must have had their negative index prostate biopsy procedure within 30 months of~     being scheduled for their repeat biopsy.~      All enrolled subjects will have all core tissues from the initial negative biopsy blinded and~     tested with the assay.~      All subjects will have serum and plasma samples obtained prior to DRE, and a urine sample~     collected immediately following DRE but in advance of the repeat biopsy; samples will be~     blinded and sent to MDxHealth for evaluation.~   "
37004|NCT03082261|"~     The purpose of the study is to evaluate sustainable pain control utilizing a multiple~     waveform enabled neurostimulator in patients with chronic, intractable pain of the trunk~     and/or limbs.~   "
37005|NCT03082248|"~     Low back pain is a common symptom, which often affects the adult population. Studies show~     that over the past two decades, costs related to spinal surgery have increased significantly,~     leading to speculation about what would be motivating this phenomenon. Although expenses with~     physical therapy treatments and less invasive surgical procedures remained relatively stable,~     the amount spent with more complex spine surgeries increased exponentially until they became~     the procedures with the highest costs in healthcare. The criteria for surgical indication are~     not uniform among surgeons and therefore a study of second opinion in spine surgeries is~     urgently needed. The present study aims to 1) quantify cost-effectiveness of second opinion~     for patients with spinal surgery indication 2) evaluate effectiveness of conservative and~     surgical treatment for degenerative diseases of the lumbar spine 3) define objective criteria~     for indication of conservative and surgical treatment using evidence-based medicine 4)~     evaluate prognosis of biological markers in the follow-up of patients with lumbar affections~     5) evaluate interobserver agreement of physicians in relation to the diagnoses and treatment~     proposals in patients with diseases of the lumbar spine 6) verify effectiveness of patients~     who were operated on, compared to patients who were not operated. A prospective cohort study~     will be conducted, in which patients with an indication of surgical spinal treatment will be~     evaluated for a second opinion. First evaluation diagnoses and indications for patient~     treatment will be compared with the second opinion evaluation. All patients who choose to~     participate on the study will be followed up for a year for evaluations concerning~     cost-effectiveness, pain, quality of life, function and blood biomarkers. The outcomes will~     be compared using linear or generalized mixed models and descriptive analyzes of the study~     population program will be carried out; Statistical agreement will be observed between the~     first and second opinion and also patient acceptance rates for the treatment proposed in the~     second indication, evaluating the validity of the project approach. A five-year budget impact~     analysis will also be carried out, taking into account the population who was eligible for~     treatment according to the admission flow of a private outpatient setting.~   "
37006|NCT03082235|"~     Study E6742-A001-001 is a randomized, double-blind, placebo-controlled, single ascending dose~     study conducted to evaluate the safety, tolerability, pharmacokinetics (PK), and~     pharmacodynamics (PD) of single ascending oral doses of E6742 in healthy adult participants.~   "
37007|NCT03082222|"~     This is a non interventional prospective study. Centers will enroll adult participants with~     partial onset seizures with or without secondary generalisation for whom the clinician has~     decided to initiate eslicarbazepine acetate (ESL) as an adjunctive therapy or monotherapy~     prior to the decision to take part in this study. Participants to be enrolled into the study~     will receive ESL either as an adjunctive therapy to one baseline antiepileptic drug (AED) or~     to at least two baseline AEDs or as monotherapy. Participants will be seen at baseline and at~     a follow-up visit after approximately 6 months to assess retention, efficacy, tolerability,~     quality of life (optional), and cognitive performances (optional).~   "
37008|NCT03082209|"~     This is an open-label, Phase I, dose-escalation study to determine the maximum tolerated dose~     (MTD) and/or recommended phase two dose (RPTD), and evaluate the safety, efficacy, and~     pharmacokinetic (PK) profile of ABBV-621 for participants with previously treated solid~     tumors or hematologic malignancies.~   "
37009|NCT03082196|"~     The purpose of the study is to determine the efficacy of Advantage Anti-Caries Varnish.~     Single-center, double-blind, controlled Phase 2 study with parallel groups of children.~     Subjects will be stratified by early childhood education center and then randomized to~     receive either test varnish or control varnish topically to the teeth. Treatment will be~     administered quarterly for up to 24 months. The primary outcome is surface-level primary~     molar caries increment (d2mfs) at 24- months post baseline.~   "
37010|NCT03082183|"~     The primary objective of this trial is to investigate the relative bioavailability of a~     single dose of BI 425809 when given alone (Reference, B) compared with co-administration~     (Test, A) on the 7th day of a 10-day treatment with rifampicin following oral administration~     in healthy male volunteers.~   "
37011|NCT03082170|"~     The investigators hypothesize that partial robotic tongue base resection surgery and / or~     soft palate surgery, as a treatment for sleep apnea affect the swallowing quality.In order to~     characterize the dysphagia The investigators will locate participants undergoing this surgery~     more than six months ago.The investigators will test their swallowing by fiberoptic~     endoscopic evaluation of swallowing (FEES) and let participants fill out a questionnaire~     regarding swallowing disorders swallowing dysfunction questionnaire (SDQ). Also the~     investigators will use data collected from participants who have undergone this surgery and~     already had these tests due to swallowing complaints.~   "
37012|NCT03082157|"~     Mighty Men is a 6-month faith-based weight-loss intervention for obese African American men~     35-74 years old being conducted in Atlanta, GA.~   "
37032|NCT03081897|"~     In the clinical trial the investigators will observe the impact of regional anesthesia in~     addition to a general anesthesia on the expression of substance P in patients with unilateral~     Head or Neck cancer undergoing unilateral Neck Dissection. The investigators will perform an~     unilateral regional cervical plexus block on the tumor side. The tissue of the tumor side~     will be analysed by immunohistology, measuring the expression of the Substance P.~   "
37013|NCT03082144|"~     It has been proved that concurrent radiotherapy (RT) and intrathecal methotrexate (MTX) for~     leptomeningeal metastases (LM) from solid tumors with adverse prognostic factors showed great~     effectiveness and safety. Cytarabine(Ara-C) is another agent which is commonly used for~     intrathecal chemotherapy. The purpose of the study is to observe the effectiveness and safety~     of concurrent RT and intrathecal chemotherapy for LM from solid tumors. In addition, the~     effectiveness of these two types of agents (MTX and Ara-C) in the concurrent~     chemo-radiotherapy will be compared in this study. This is a randomized controlled, parallel~     group, and phase II clinical trial. The object of this study is newly diagnosis patients with~     leptomeningeal metastases from solid tumors, who will accept the treatment of involved-field~     RT combined with concurrent intrathecal-MTX or intrathecal-Ara-C, respectively. Major~     endpoint is clinical response rate. Secondary endpoints are time to progression,severe~     adverse events and overall survival.~   "
37014|NCT03082131|"~     The objective of this study is to determine the effect of wheat enriched in resistant starch~     (RS) on the generation of fermentation products by the lower gut microbes, the fecal~     microbiota profile, intestinal metabolites, and the glycemic response to a test meal compared~     to regular wheat.~   "
37015|NCT03082118|"~     Single arm study of the Vesair Balloon in postmenopausal women.~   "
37016|NCT03082105|"~     Sufficient oxygenation is critical for completely buried avalanche victims to avoid~     life-threatening consequences during hypoxic exposure. Snow contains a remarkable capacity to~     maintain air availability; it was suspected that the snow physical properties affect the~     development of hypoxia and hypercapnia. The aim of this study was to evaluate the influence~     of different snow physical properties on the development of hypoxia and hypercapnia in~     subjects breathing into an artificial air pocket in snow. Twelve male healthy subjects~     breathed through an airtight face-mask and 40cm tube into an artificial air pocket of 4L.~     Every subject performed three tests on different days with varying snow characteristics.~     Symptoms, gas and cardiovascular parameters were monitored up to 30min. Tests were~     interrupted at SpO2 <75% (primary endpoint); or due to subjective symptoms like dyspnea,~     dizziness, and headache (i.e. related to hypercapnia). Snow density was assessed via standard~     methods and micro-computed tomography (CT) analysis, and permeability and penetration with~     the snow micro-penetrometer (SMP).~   "
37017|NCT03082092|"~     Osteoarthritis of the knee is a common and important condition in our society. Despite~     various anesthetic methods and pain medications, pain after operation still remains as a~     challenge.~      Steroids plays a role in decreasing the inflammatory reaction and stress response from~     surgery.~      This study is to evaluate the use of an additional steroid injection, on top of usual pain~     killers and anesthesia, on the effect of pain control and recovery after total knee~     replacement.~      50 subjects will be recruited, half of them will be randomized to receive a single dose of~     steroid injection before operation while the other half will receive a placebo. All the~     doctors, patients and physiotherapists are not aware of the allocation. Apart from the~     steroid or placebo injection, all the other treatment (eg: surgery, medications,~     rehabilitation protocol etc) will be the same. Doctors and physiotherapists will assess the~     subjects at 24, 30, 48 hours after surgery and upon discharge for their pain relief and~     recovery. Any complications will also be documented.~   "
37018|NCT03082079|"~     Data are currently insufficient to guide the management of very small gastrointestinal~     stromal tumors（GISTs）（< 2 cm) discovered incidentally on endoscopy,this study is designed to~     collect the medical records of patients in different treatment group with long-term follow-up~     data,and attempts to evaluate the usefulness of regular endoscopic~     ultrasound（EUS）surveillance and the necessity,safety and feasibility of endoscopic submucosal~     dissection（ESD）for small GISTs,thus provide evidence for the revision of the guideline.~   "
37019|NCT03082066|"~     Retrospective observational study: Soft tissue and bone diameters are assessed in MRI and CT~     scans of patients. Data is compared with recommendations of intraosseus needle producers to~     assess whether the information provided by the producers can be optimised. Study sites are~     head of humerus bone, distal femur, proximal and distal tibia in accordance with recommended~     intraosseus access sites.~      Primary and secondary outcome parameters will be assessed at one time only, i.e. when the~     patient has received MRI or CT scan for the diagnostic work up of their primary disease. Data~     collection for a given patient in this study can be completed within one session, e.g. 5-10~     minutes. No additional investigation is required for this retrospective study.~   "
37020|NCT03082053|"~     The purpose of this study is to explore safety and efficacy of varlitinib administered as~     monotherapy in Japanese subjects with advanced or metastatic solid tumors, and administered~     as combination with capecitabine in Japanese subjects with advanced or metastatic biliary~     tract cancer. Also to evaluate pharmacokinetics (PK) of varlitinib, capecitabine and its~     metabolite.~   "
37021|NCT03082040|"~     This is a prospective, triple-blinded and randomized controlled trial examining the effects~     of a home-based breathing training assisted with biofeedback on menopausal symptoms and~     autonomic functions among community menopausal women. We also examines whether the changes in~     autonomic functions would be mediators between slow breathing and menopausal symptoms. This~     study will include menopausal women, aged from 45 to 64, who experienced menopausal symptoms.~     Participants will be randomly assigned to either an intervention group (n = 80) or a~     waiting-list control group (n = 80). The intervention group will undergo the home-based~     breathing training 20 minutes twice daily and participants in the control condition will~     participate the same breathing training after a four-week waiting list period. The primary~     outcome measures are menopausal symptoms measured by symptom diaries of menopausal symptoms~     and the Greene Climacteric Scale (GCS). Secondary outcome measures are autonomic functions~     expressed by blood pressure (BP), heart rate (HR) and heart rate variability (HRV).~     Measurements will be taken at baseline, week 4, and week 8.~   "
37022|NCT03082027|"~     Sonographic Assessment of The Median Nerve in Carpal Tunnel Syndrome to assess the surgical~     importance and added value of superficial ultrasonography in assessment of the median nerve~     in CTS.~   "
37023|NCT03082014|"~     Multicentre, multinational, prospective randomised, open-label, 3 sequence crossover phase~     III b clinical trial with blinded endpoint assessment (PROBE-design)~        -  in 75 patients with sporadic small vessel diseases (SVDs) and~        -  in 30 patients with cerebral autosomal dominant arteriopathy with subcortical infarcts~          and leukoencephalopathy (CADASIL)~   "
37024|NCT03082001|"~     Newborn infants in the neonatal intensive care nursery experience multiple, painful tissue~     damaging procedures daily.~      Preterm especially extremely low birth weights and critically ill newborns admitted to a~     Neonatal Intensive Care Unit (NICU) undergo repeated skin-breaking procedures that are~     necessary for their survival. Sucrose is the accepted clinical standard nonpharmacological~     intervention for managing acute procedural pain for these infants.~      However its role in extremely low birth weight infants still need to be addressed. The exact~     dose and concentration of oral sucrose is still not clear.~      When a Medline search was carried out to evaluate the role of two different concentrations~     (12% vs 24%) of oral sucrose in reducing pain in extremely low birth weight babies, very~     limited data was available. Cochrane Systemic Review also indicated that specific attention~     to the efficacy and safety of sucrose administration in extremely low birth weight preterm~     infants needs to be further investigated. More so, no work on this aspect was identified from~     the Indian subcontinent. Hence, the current study was planned with an aim to study the~     effects of 12% and 24% oral sucrose in extremely low birth weight infants during initiation~     of venipuncture and also study the side effects if any associated with these concentrations.~     This is a preliminary work on this topic, the results would therefore need to be interpreted~     with caution. However, the findings and the study design of this work will provide suitable~     platform for future well powered studies on this population.~   "
37025|NCT03081988|"~     1. Retrospective review of old patients~             -  Analysis of prediction factors for concomitant chemo-radiotherapy in locally~               advanced and advanced esophageal cancer from 2005 to 2015~        2. Prospective case-control study: RNA sequencing & miRNA microarray~             -  naive esophageal cancer patients who have a plan to receive concomitant~               chemo-radiotherapy~                  -  acquirement of tissue, blood, clinical information~                  -  isolation of RNA, DNA, serum database of clinical & demographic information~           ***Analysis of mRNA sequencing / miRNA sequencing**** first analysis of RNA sequencing:~          bioinformatician second analysis of RNA sequencing: principle investigator~        3. Experimental set for qPCR (esophageal tissue) study group~        4. TMA for screened exon gene~        5. validation set for qPCR (esophageal tissue)~        6. follow-up of circulating miRNA in blood (baseline blood & post-CCRT blood 3M, 6M, 12M)~        7. Prediction model for CCRT response in esophageal Cancer based on clinical and molecular~          factors~        8. Validate the prediction model.~   "
37026|NCT03081975|"~     The aim of this study is to compare ADR using HD-NBI or HD-WLE during screening and~     surveillance colonoscopies.~   "
37027|NCT03081962|"~     A prospective randomized clinical trial will be performed. Patients will be randomized in 2~     groups. The experimental group will undergo the combined application of intraperitoneal~     irrigation with clindamycin and gentamicin solution, fascial closure with~     Triclosan-impregnated sutures and application of mupirocin ointment over the skin staples, in~     addition to the standard care measures. The control group undergo only the standard care~     measures.~      Incisional surgical-site infection will be investigated.~   "
37028|NCT03081949|"~     Peripartum cardiomyopathy (PPCM) is a global disease with significant morbidity and~     mortality, and Nigeria probably has the highest burden of the disease in the world.~     Unfortunately, much about the disease including its aetiology, epidemiology and treatment is~     not yet well described. This will be a prospective, national, multicenter cohort study,~     conducted in centres in Nigeria. It is expected that approximately 500 patients with PPCM and~     500 apparently healthy pregnant women will be recruited over a 6-month period with follow‐up~     at 3-monthly intervals for 18 months.~   "
37029|NCT03081936|"~     This pilot study primarily aimed to compare effects of breast feeding, A1 versus A2®cow milk~     based formula on alimentation and gastrointestinal digestion. The impact of the study~     products on fecal myeloperoxidase (MPO), short-chain fatty acid (SCFA), secretory~     immunoglobulin A (sIgA) concentration, gastrointestinal tolerance, defecating habit and~     infant growth were also evaluated.~   "
37030|NCT03081923|"~     Background:~      The prognosis of pts who have failed multiple chemotherapy (CT) regimens is quite dismal.~     PD-L1 is frequently expressed by immunohistochemistry (IHC) in germ cell tumors (GCT). D is a~     monoclonal antibody (mAb) that inhibits the binding of PD-L1. T, an anti-CTLA4 mAb, is an~     immunomodulatory therapy. Combination immunotherapy has shown improved activity compared to~     monotherapy. The investigators aimed to investigate the activity of D, alone or in~     combination with T, in chemorefractory GCT.~      Trial Design:~      This is an open-label, randomized, 3-stage, phase 2 study. Pts who have failed ≥2 prior CT~     regimens (including high-dose CT) will be randomized to receive one of the following: D, 1.5~     g via IV infusion q4w, for up to a total of 12 months (13 doses/cycles) alone or with T, 75~     mg IV q4w, starting on week 0, for up to 4 months (4 doses/cycles). Serum tumor markers,~     computed tomography and fluorodeoxyglucose positron emission tomography (FDG-PET) scans will~     be repeated q8 weeks. The primary endpoint is the objective response-rate (ORR=complete~     response or partial response with normal markers). H0: ORR rate ≤10%, H1: ORR ≥25%, type I~     and II error rates at 10%.~      In stage 1, 11 pts will be allocated in each arm. According to Gehan's rule, the trial will~     be terminated whenever no response will be observed. 29 additional pts will be added to each~     arm fulfilling stage 1 criteria. ORR in ≥7 pts will be required. In stage 3, pts from stage~     1-2 of both arms will be retrospectively evaluated for Programmed cell Death Ligand-1(PD-L1)~     IHC. The Ventana PD-L1 IHC assay will be used. In case of negative findings at the end of~     stage 2, if the target benefit is likely to occur only in PD-L1+ pts, further study~     prosecution in accordance with an enrichment strategy will be undertaken.~      In particular, predictive power (PP) will be calculated assuming expansion of PD-L1+ cohorts~     up to a maximum of 60 pts. Each arm will be categorized as not promising (PP<30%) or~     promising (PP ≥30%). The promising one will enter the stage 3. Should both arms be judged~     promising, the one yielding ≥20% PP advantage will be selected; monotherapy will be preferred~     otherwise. Details on the algorithm to be used for PD-L1 IHC in this study will be finalized~     (EudraCT number 2016-001688-35).~   "
37031|NCT03081910|"~     Patients eligible for this study have a type of blood cancer called T-cell leukemia or~     lymphoma (lymph gland cancer).~      The body has different ways of fighting infection and disease. No one way seems perfect for~     fighting cancers. This research study combines two different ways of fighting disease,~     antibodies and T cells, hoping that they will work together. Antibodies are types of proteins~     that protect the body from bacterial and other diseases. T cells, also called T lymphocytes,~     are special infection-fighting blood cells that can kill other cells including tumor cells.~     Both antibodies and T cells have been used to treat patients with cancers; they have shown~     promise, but have not been strong enough to cure most patients.~      T lymphocytes can kill tumor cells but there normally are not enough of them to kill all the~     tumor cells. Some researchers have taken T cells from a person's blood, grown more of them in~     the laboratory and then given them back to the person. The antibody used in this study is~     called anti-CD5. It first came from mice that have developed immunity to human leukemia. This~     antibody sticks to T-cell leukemia or lymphoma cells because of a substance on the outside of~     these cells called CD5. CD5 antibodies have been used to treat people with T-cell leukemia~     and lymphoma. For this study, anti-CD5 has been changed so that instead of floating free in~     the blood it is now joined to the T cells. When an antibody is joined to a T cell in this way~     it is called a chimeric receptor.~      In the laboratory, the investigators have also found that T cells work better if proteins~     that stimulate T cells are also added, such as one called CD28. Adding the CD28 makes the~     cells grow better and last longer in the body, thus giving the cells a better chance of~     killing the leukemia or lymphoma cells.~      In this study investigators are going to attach the CD5 chimeric receptor with CD28 added to~     it to the patient's T cells. The investigators will then test how long the cells last. These~     CD5 chimeric receptor T cells with CD28 are investigational products not approved by the Food~     and Drug Administration .~   "
37033|NCT03081884|"~     This study is for patients who have a high risk of metastatic prostate cancer (cancer that~     has spread outside of the prostate) who are going to have radical prostatectomy. The~     Anti-1-amino-3-[18F]fluorocyclobutyl-1-carboxylic acid (FACBC or Fluciclovine) positron~     emission tomography (PET) scan is a new imaging approach that has promising results in~     showing progression of cancer. The goal of this study is to determine if FACBC PET imaging~     will detect metastatic disease in patients with high risk prostate cancer who have negative~     conventional cross-sectional imaging such as computed tomography (CT) and/or magnetic~     resonance imaging (MRI), as well as bone scan and/or sodium fluoride PET. FACBC PET imaging~     may help detect metastatic prostate cancer in patients with newly diagnosed high risk primary~     prostate cancer and potentially improve staging of the cancer. Additionally, the researchers~     will compare the FACBC uptake in the prostate with uptake of FACBC detected in metastasis.~     They will also analyze and compare the prostate tissue, serum and urine parameters that are~     linked to higher rates of FACBC positivity.~   "
37034|NCT03081871|"~     Risk factors for cardiovascular disease are poorly controlled even for patients who~     frequently visit their physician, leading to large numbers of preventable cardiovascular~     events such as heart attacks and strokes. Research from integrated healthcare systems~     suggests that risk factors can be controlled better and treatment strategies for~     cardiovascular disease can be markedly improved by using a centralized cardiovascular risk~     service (CVRS) managed by pharmacists. The investigators are confident that a~     pharmacist-managed mHealth CVRS can become a strategy in un-integrated healthcare settings to~     markedly reduce cardiovascular events in the United States.~   "
37035|NCT03081858|"~     This is a single-arm, phase 1/2a study of formulated paclitaxel in subjects with low-grade,~     noninvasive papillary carcinoma (stage Ta) of the bladder.~      Part 1 of the study will enroll 6 subjects (3 per cohort) with low-grade, stage Ta~     transitional cell carcinoma (TCC) of the bladder who will receive escalating doses of~     paclitaxel formulated as TSD-001 every 2 weeks for 6 treatments until Dose Limiting Toxicity~     (or until the Maximum Deliverable Dose) is observed (Maximum Tolerated Dose established).~      Part 2 of the study will enroll an additional 10 subjects with low-grade, stage Ta~     (multifocal) TCC of the bladder who will receive weekly TSD-001 for 6 weeks at the highest~     nontoxic dose (i.e., MTD) established in part 1 of the study.~   "
37036|NCT03081845|"~     This is a multiple-sites, double-blinded, randomized, controlled, parallel-designed,~     cross-over study among healthy preschoolers with 5 days consumption of A2 or A1 milk to~     compare the effects on gut inflammation, gastrointestinal symptoms and behavioral well-being.~   "
37037|NCT03081832|"~     The objective of this study is to collect data on tolerance and effects of early treatment~     with oxytocin in children with Prader Willi Syndrome aged from 3 to 4 years and to compare~     these infants with not treated age-matched infants with Prader Willi Syndrome.~   "
37038|NCT03081819|"~     A Phase I study of SH003 for evaluate safe dose range in patients with solid cancer.~      The first dose group receives SH003 for 3 weeks. If the adverse events occur in less than one~     in six participants, the dose is escalated.~      The second dose group receives SH003 for 3 weeks. If the adverse events occur in less than~     one in six participants, the dose is escalated.~      The third dose group receives SH003 for 3 weeks.~   "
37039|NCT03081806|"~     This is a Phase 3, Multicenter, 12-Week, double-blind and 40-Week open label Study to~     Evaluate the Efficacy and Safety of X0002 Spray in relief of the signs and symptoms of~     subjects with Osteoarthritis of the Knee.~   "
37040|NCT03081793|"~     The aim of the study is to the reliability and feasibility of a novel optical heart rate~     monitor in hospital patients. Especially patients with atrial fibrillation are included.~     Patients will be monitored for two hours during routine post-operative care. The data from~     study device will be compared to routine monitoring. The design of the study is a Pilot~     feasibility study.~   "
37041|NCT03081780|"~     This is a Phase I open-label dose escalation study of a single infusion of FATE-NK100 and a~     short course of subcutaneous interleukin-2 (IL-2) administered after lymphodepleting~     chemotherapy (CY/FLU) in subjects with refractory or relapsed acute myelogenous leukemia~     (AML). FATE-NK100 is a natural killer (NK) cell product that is enriched for NK cells with an~     adaptive, or human cytomegalovirus (CMV)-induced, phenotype. The NK cell product is~     comprised of peripheral blood (PB) leukocytes sourced from a related donor~     (HLA-haploidentical or better but not fully HLA-matched) that is seropositive for~     cytomegalovirus (CMV+), and enriched for adaptive NK cells by depletion of CD3+~     (T-lymphocytes) and CD19+ (B-lymphocytes) cells followed by ex-vivo culture expansion.~   "
37042|NCT03081767|"~     The investigators wish to determine if standard and digital PET/CT scanners provide~     equivalent results for disease detection and diagnosis.~   "
37043|NCT03081754|"~     When indicated, a conservative management plan of IUGR was undertaken. Doppler studies were~     performed within the last week before delivery The results of Umbilical artery (UA) Doppler~     velocimetry were categorized as normal , increased , absent, and reversed . Patients were~     admitted for close surveillance in the case of worsening of maternal or fetal conditions~     (e.g. absent or reversed UA blood flow, and severe preeclampsia).~      Tissue samples The general shapes of placentas were assessed. The collected placentas were~     weighed by trimming the membranes and umbilical cord. Then the diameters and thickness of~     placentas were noted. The position of insertion of umbilical cord on the fetal surface of~     placenta was observed. Transverse cuts were made through the maternal surface at a distance~     of 1-2 cm in bread loaf manner and examined for the pale areas. All placentas were immersed~     in 10% formalin overnight and examined on the next day. For each placenta, blocks containing~     cord, membrane and full thickness of villous tissue were prepared. Whole thickness villous~     tissue blocks were obtained from three zones, i)central zone ii) peripheral zone and iii)~     intermediate zone between the first two zones, so as to include all areas of placenta.~      Placental bed biopsies were obtained at Caesarean sections with direct visualization of the~     placental site. Biopsies of at least 1cm were taken. The specimens were fixed in buffered~     formalin. The tissues were processed and stained with Haematoxlyin and Eosin. Microscopic~     study of placenta was carried out utilizing a set of standard criteria for villous and~     intervillous lesions~      Immunohistochemistry Expression of VEGF and CD34 was analyzed in 75 (50 placenta of IUGR and~     25 of control) placental villous tissues.~      Immunostaining was performed by the streptavidin-biotin-peroxidase method. Evaluation of~     immunohistochemical staining To determine the MVD, the stained placental vasculature. Tissue~     sections were initially screened microscopically at low power (100×) to identify the areas of~     highest vascularization (hot spots).~      Evaluation of immunohistochemical staining of VEGF:~   "
37044|NCT03081741|"~     Conduct a prospective study to detect the change of ctDNA of surgical lung cancer patients.~   "
37045|NCT03081728|"~     to put a catheter in interscalene brachial plexus USG guided and give a bolus of drug~     followed by 24 hours continous infusion of drug~   "
37046|NCT03081715|"~     This study will evaluate the safety of PD-1 knockout engineered T cells in treating advanced~     esophageal cancer. Blood samples will also be collected for research purposes.~   "
37048|NCT03081689|"~     Phase II, single-arm, open-label multicenter study that assesses feasibility, safety and~     efficacy of combined neoadjuvant chemotherapy and immunotherapy with Nivolumab 360 mg IV Q3W~     + Paclitaxel 200mg/m2 + Carboplatin AUC 6 IV Q3W in resectable stage IIIA N2-NSCLC adult~     patients followed by adjuvant treatment for 1 year with Nivolumab 240 mg IV Q2W for 4 months~     and Nivolumab 480mg Q4W for 8 months.~   "
37049|NCT03081676|"~     The most prevalent monogenetic diabetic subtype is named maturity onset diabetes of the young~     type (MODY3) or hepatocyte nuclear factor 1α (HNF1A)-diabetes. The aim of this study is to~     evaluate the effects of supra-physiological levels of GIP and GLP-1, respectively, on insulin~     and glucagon secretion at fasting plasma glucose (FPG) and post-prandial PG levels (1.5 ×~     FPG) in patients with HNF1A-diabetes and matched healthy controls treated with or without a~     low dose of glimepiride (sulphonylurea). In addition, we will evaluate the maximal insulin~     and glucagon secretory capacity in both groups.~   "
37050|NCT03081663|"~     This study is a randomized clinical trial comparing standard medial para-patellar total knee~     arthroplasty with a quadriceps sparing mid-vastus approach. Patients who are medically well~     and have a good support structure at home will be randomized to a standard or quadriceps~     sparing surgical approach stratified by type of analgesia (adductor canal block or local~     infiltration). We will compare patient satisfaction and costs from the perspective of the~     Ministry of Health, the institution, society and the patient.~   "
37051|NCT03081650|"~     The primary purpose of this study is to show whether at home usage of the AIRVO warm~     humidifier can potentially reduce the number of exacerbations in patients with significant~     respiratory insufficiency. Eligible participants of the study must have a diagnosis of~     chronic obstructive pulmonary disease (COPD) stage II-IV..~   "
37052|NCT03081637|"~     The risk of recurrence after hepatectomy for hepatocellular carcinoma (HCC) is very high.~     Having a predictive marker of early recurrence (ER) would be desirable to personalize the~     follow-up and possibly develop new targeted therapy. The aim of this study was to test the~     expression of Filamin A (FLNA) in a cohort of patients operated for HCC.~   "
37053|NCT03081624|"~     Beginning school is an important milestone for children. Children's readiness for school~     involves cognitive, physical, and emotional development. While the majority of children born~     preterm are able to transition from preschool to kindergarten with little difficulty, some~     children experience challenges during this time. Factors that negatively influence children's~     success in kindergarten include their age, socioeconomic status, neurological status and~     their ability to interpret sensory information from their environment.~      This study was planned to explain the relationship between the primary school readiness and~     the neurological status of preterm born children.~   "
37054|NCT03081611|"~     Randomized control trial, Ram cannula VS short nasal prongs for delivering Non Invasive~     Positive Pressure Ventilation (NIPPV) for preterm infants~   "
37055|NCT03081598|"~     This is a Phase 2, multi-center, double-blind, placebo-controlled study of the safety and~     effect of PBI-4050 at doses ranging from 400 mg to 1200 mg on relevant biomarkers in subjects~     with inadequately-controlled T2DMS on stable background antidiabetic therapy.~   "
37056|NCT03081585|"~     The aim of this study is to investigate the influence of different metabolic states and~     hormonal satiety signalling on responses in neural reward networks.~   "
37057|NCT03081572|"~     This is a small observational study aimed at observing differences in platelet function in~     HIV patients on abacavir versus tenofovir based anti-HIV drugs. There is some correlation~     between platelet activation and cardiovascular disease- this study will act as a pilot to see~     if platelet activation among abacavir users may explain the correlation between abacavir and~     cardiovascular disease in HIV positive patients.~      This study will enroll 44 participants total; 22 on abacavir-based treatment, 22 on~     tenofovir-based treatment. There is only one study visit which includes a blood draw,~     physical assessment, and review of medical history.~   "
37058|NCT03081559|"~     Transgender women (assigned 'male' at birth but who do not identify as male) are~     disproportionately impacted by HIV and have culturally unique barriers and facilitators to~     engagement in HIV care. Transgender women living with HIV (TWH) are less likely than others~     to take antiretroviral therapy (ART), and those who initiate ART have lower rates of ART~     adherence, lower self-efficacy for integrating ART into daily routines, and report fewer~     positive interactions with health care providers than non-transgender adults. As a result,~     TWH have an almost three-fold higher viral load than non-transgender adults in San Francisco;~     in Los Angeles, TWH are less likely to be virally suppressed than any other behavioral risk~     group. In formative work, the investigators have identified culturally-specific and~     modifiable barriers to HIV treatment engagement among TWH, including prioritization of~     transition-related health care (i.e. hormone therapy) at the expense of HIV treatment,~     avoidance of HIV care settings due to past negative health care experiences, misinformation~     about ART including potential drug interactions with hormones, intensified HIV stigma, low~     levels of social support, and poor coping skills. There are both individual and public health~     consequences to poor engagement in care among TWH stemming from high transmission risk~     factors, including substance abuse, high numbers of sex partners, engagement in sex work, and~     high rates of mental illness. These findings strongly suggest that TWH face unique challenges~     to engaging in and adhering to HIV treatment, and that the public health consequences for~     poor engagement in this population are of grave concern. Interventions to mitigate these~     barriers to engagement in care are critical in efforts to alter the pattern of HIV-related~     disparities that lead to disproportionately poor health outcomes for this highly vulnerable~     and marginalized population. The investigators are conducting a randomized controlled trial~     of a theory-driven, population-specific, piloted intervention to improve engagement in care~     for TWH. Grounded in the investigators' Models of Gender Affirmation and Health Care~     Empowerment, the proposed research is the first to systematically intervene on complex~     barriers to optimal engagement in HIV care for TWH. The investigators have developed and~     piloted the Healthy Divas intervention to optimize engagement in HIV care for TWH at elevated~     risk for treatment failure and consequential morbidity, mortality, and transmission of HIV.~   "
37059|NCT03081546|"~     This study plans to assess the effectiveness of performance-based functional assessments~     (PBFAs) and cognitive assessments in diagnosing Alzheimer's disease in Hispanic/Latino~     populations. The information from this study will be analyzed with data from the Rocky~     Mountain Alzheimer's Disease Center Bio-AD study (NCT02612376).~   "
37068|NCT03081429|"~     With the development of population aging, the incidence of covert stroke and cognitive~     dysfunction gradually increased. Currently, there is still lack of prospective cohort study~     with large sample size on the relationship between perioperative covert stroke and~     postoperative cognitive dysfunction. The investigators will perform a prospective cohort~     study. The aim of the study is to determine whether there is an association between~     perioperative covert stroke and postoperative cognitive dysfunction in elderly patients~     undergoing noncardiac surgery.~   "
37069|NCT03081416|"~     This is a randomized, single-blind, placebo controlled trial to evaluate the efficacy of~     sub-dissociative dose ketamine versus standard care therapy for acute headache management of~     in patients presenting to the emergency department with headache as the chief compliant.~   "
37060|NCT03081533|"~     The task of caring for an individual with Alzheimer's disease is often carried out by elderly~     caregivers who, due to their motor and psychosocial alterations due to the aging process, may~     also be exposed to the development of the frailty syndrome. Therefore, it is necessary to~     promote the engagement and adherence of these caregivers in physical activities. In this~     sense, circle dances have received attention, either as a modality of physical activity or~     therapy, and, although little studied, seem to be an appropriate type of intervention for the~     elderly caregivers. Thus, this study aims to evaluate the effect of 12 weeks of circle dances~     on cognitive, psychological, physical and frailty-related variables in elderly caregivers of~     Alzheimer's patients. It is expected that the practice of circle dances will be able to~     reduce stress levels and depressive symptoms of elderly caregivers; Reduce and / or maintain~     the perception of care overload and improve some functional components such as: mobility;~     balance; muscle strength of legs; walking speed; fatigue and level of physical activity.~   "
37061|NCT03081520|"~     The aim of this study is to examine acute affective responses during and after a series of~     exercise sessions with different intensities in young healthy adults. The study is a~     randomized controlled trial with three different groups (A: moderate continuous training~     (MIT), B: high-intensity aerobe interval training (HAIT), C: high-intensity sprint interval~     training (HIIT)). Healthy adults aged 18-40 years (n=30) will be invited to participate. Each~     participant will perform a VO2max test followed by five session of the randomized type of~     training. The sessions will be completed within two weeks. The participants will complete~     questionnaires regarding exercise motivation (Behavioral Regulation of Exercise~     Questionnaire), mood (Positive and Negative Affect Scale, Profile of Mood States, Visual~     Analogue scale, Self-assessment Manikin Rating Scale) and perceived exhaustion (Borg Ratings~     of Perceived Exertion scale). In addition, blood lactate and heart rate will be obtained~     during and after each session.~   "
37062|NCT03081507|"~     Studies have reported Muslims in the US and NYC face numerous language and healthcare access~     barriers. This is a randomized randomized controlled design will be used to test the efficacy~     of a Patient Navigation (PN) intervention to increase participation in breast and/or cervical~     cancer screening among Muslim women age 40 - 75 years living in NYC. Study participants will~     be randomized to an Lay Health Workers (LHW) led small media intervention arm (SM-LHW) or a~     LHW-led patient navigation plus small media intervention arm (PN-LHW). A specific aim of the~     study is to develop, implement and evaluate the efficacy of a two-arm, randomized control~     trial designed to increase receipt of breast and/or cervical cancer screening among Muslim~     women aged 40 -75 years in New York City (NYC).~   "
37063|NCT03081494|"~     This is a phase Ib study of PDR001 in combination with regorafenib in adult patients with~     previously treated metastatic microsatellite stable (MSS) colorectal cancer. The study will~     assess primarily the safety and tolerability and then the efficacy of PDR001 in combination~     with regorafenib. Particular attention will be paid to the level of activity of study drug~     combinations in CMS4 patients (retrospective analysis).~   "
37064|NCT03081481|"~     The purpose of this study is to determine a safe, effective, and tolerable dose of PRX302 for~     the treatment of low to intermediate risk prostate cancer.~   "
37065|NCT03081468|"~     In current, clinical ophthalmology, a range of specialised testing allows comprehensive~     evaluation of ocular health. These tests have typically evolved over many years to ensure~     their clinical validity. For example, the assessment of visual acuity has traditionally been~     measured with Snellen letter charts from a distance of six metres (20 feet), leading to the~     phrase 20/20 vision. Despite this, the limitations of Snellen testing are well established~     and more sophisticated testing is now available (e.g., logMAR testing using ETDRS (Early~     Treatment Diabetic Retinopathy Study) charts). Many other diagnostic tests have undergone~     similar cycles of refinement, often over extended time periods. Therefore, it should be~     incumbent on any new device to undergo detailed evaluation of its validity (how its~     measurements agree with other testing) and its repeatability (the variability when a further~     measurement is obtained in short time period, by the same operator and under the same~     conditions).~      Binocular OCT extends the application of OCT devices beyond that of simple, cross- sectional~     imaging to a diverse array of diagnostic tests. The binocular design also removes the need~     for additional personnel to perform testing (i.e., the device can be self-operated in an~     automated manner), and allows for novel testing to be performed that is not possible with~     monocular imaging. In particular, binocular OCT devices have the potential to perform~     automated, quantitative pupillary measurements - an entirely novel application for this~     imaging modality.~      This study will assess the validity and repeatability of pupil measurements using binocular~     OCT.~   "
37066|NCT03081455|"~     A prospective, non-interventional study to evaluate the impact of a process engineering~     intervention on screening and testing outcomes for common hereditary cancer syndromes in~     community-based OB/GYN settings.~   "
37067|NCT03081442|"~     Groups of study:~      120 candidates for Cu T 380A IUD insertion were enrolled in the study. They were divided into~     two groups: Group 1: Sixty women received 600 micrograms of misoprostol vaginally as deep as~     possible six hours before IUD insertion.~      Group 2: Sixty women received the placebo vaginally. The placebo and misoprostol were put in~     120 numbered closed envelopes according to the table of random numbers and an envelope was~     allocated to each patient accordingly.~      Methodology:~      All patients were subjected to the following:~      (i) Complete history taking (ii) Proper counseling: (iv) Examination: (v) 600ug misoprostol~     (3tablets Misotac®, ( Sigma Pharmaceutical Industries, Egypt )or placebo were administered~     Vaginally as deep as possible 6 hours before insertion of the IUD by gynecologist .~      (vi) Insertion of IUD: (TCu-380A®,Pregna International Ltd, India ) After full history taken~     , Proper counseling, Informed consent is taken from each patients, examination ( general ,~     abdominal and pelvic )to exclude any pathology .~      A careful bimanual examination was done prior to IUD insertion. The cervix was exposed by~     introducing a vaginal speculum, the cervix and vaginal vault were cleaned with povidone-~     iodine solution.~      The Next step was to sound and measure the depth of the uterus. The IUD was folded into the~     insertion tube immediately prior to insertion. The cervix was grasped with a tenaculum, and~     gently pulled downward to straighten the angle of flection.~      The insertion tube was advanced into the uterus to the correct depth as marked on the tube by~     a sliding plastic flange.~      The outer sheath of the insert was withdrawn a short distance to release the arms of the T~     and was then gently pushed inward again to elevate the opened T against the fundus of uterus~     .~      The inserter tube was then removed. Then strings were cut to project about 2-4 cm from the~     external cervical os.~   "
37236|NCT03079232|"~     OCTAV is a medical device class I, not CE marked, based on a new technique for~     high-resolution imager (cell) internal microstructures of all types of biological tissues in~     vivo or ex vivo, to a depth of penetration 800 .mu.m. It allows to explore the epidermis, the~     dermo-epidermal junction and middle dermis in a totally non-invasive (direct contact with the~     tissue without sampling).~   "
37070|NCT03081403|"~     Sensitive skin is a common problem, with 50% of women and 30% of men in Europe feel they have~     sensitive skin.~      The Quantitative sensory testing (QST) is a physico-psychic method that uses gradients~     stimuli of different modalities to measure a subjective somatosensory response. This allows~     to characterize sensory dysfunction by assessing the participation of small and large nerve~     fibers.~      The aim of this project is to characterize the presence or absence of a neurological disorder~     in patients with sensitive skin. This discovery would be a decisive argument to reinforce the~     suspicion that sensitive skins is linked to a small fiber neuropathy.~   "
37071|NCT03081390|"~     The primary goal of this study is to test the effects of a high-fat, high-carbohydrate mixed~     meal on candidate modulators of cardiovascular disease risk (inflammation, vascular~     reactivity, sympathetic nervous system tone, and response to pain) in young adult women with~     migraine compared with healthy young women. This is study enrolling both cases (women with~     migraine) and controls (women without migraine), with equal numbers of normal weight and~     obese women in each group. Participants will undergo a telephone screening and a single day~     in-person study visit.~   "
37072|NCT03081364|"~     The investigators are providing MRI in patients with non-MRI approved CIED's (Cardiac~     Implanted Electronic Devices)~   "
37073|NCT03081351|"~     This clinical trial is about the survival benefit of extended lymphadenectomy and nerve~     clearance versus standard lymphadenectomy in pancreaticoduodenectomy of pancreatic~     adenocarcinoma，which is a multicenter，prospective，ramdomized clinical trials.~   "
37074|NCT03081338|"~     Amyotrophic Lateral Sclerosis (ALS) or else known as Motor Neurone Disease (MND) is a rapidly~     progressive fatal neurological disease that strikes in the prime of life, and for which there~     is no treatment. The principal aim of management is to maintain quality of life and reduce~     the symptoms of the disease. This requires a multidisciplinary approach using best practice~     for symptom alleviation, including innovation approaches towards maximising quality of life.~     The purpose of this study is to use existing information drawn from partner countries into a~     system of care that is available to people with amyotrophic lateral sclerosis at the correct~     time, in the correct format and in a cost effective manner. This will be achieved by~     collecting details of patient and carer experiences across all stages of from diagnosis to~     end of life, including decision making in the terminal stages of the disease. A health~     economic analysis will help to identify the overall costs of disease management, provide~     models of increased efficiency that preserve and maximize quality of life, and begin to~     develop novel health economic measurement tools for terminal neurological illness. The~     completed project will provide a user-friendly best practice programme for amyotrophic~     lateral sclerosis that can be modified for management of other related degenerative diseases~     of the nervous system.~   "
37075|NCT03081325|"~     Recurrent miscarriage(RM) and recurrent implantation failure (RIF) are clinical challenge for~     clinicians and patients who are desperate for a healthy child.The specific etiology contains~     chromosomal abnormalities, reproductive anatomical abnormalities, endocrine disorders,~     reproductive system infections, autoimmune and environmental factors. However there are still~     50% to 60% RM and RIF which don't have a clear cause,mainly associated with alloimmune~     factors.Among various treatments,lymphocytes active immunotherapy is the most common~     treatment method, and its clinical efficacy is widely recognized although its action~     mechanism is not clear so far.~   "
37076|NCT03081312|"~     This research will determine (a) the unmet needs of family caregivers of adult cancer~     patients and (b) determine the impact on stress, care burden and quality of life.~      A cross-sectional questionnaire methodology will be used to answer the research questions.~     510 family caregivers at different stages of patients' cancer journey will be recruited. The~     study duration is expected to take two years. Research findings will address the knowledge~     gap of caregivers' needs and stress, burden and quality of life and support plans to help~     caregivers.~   "
37077|NCT03081299|"~     This is a prospective descriptive correlational design looking to characterize postoperative~     pain variables across various procedures that historically have significant levels of~     persistent post-surgical pain~   "
37078|NCT03081286|"~     This study evaluates the possible beneficial effect of fat grafting for post mastectomy pain~     syndrome. Half of patients will receive fat grafting and the other half of patients will~     receive sham.~   "
37079|NCT03081273|"~     Corynebacterium spp have been considered as innocuous commensals of human skin, but are now~     accepted as important opportunistic pathogens responsible for various nosocomial infections,~     especially implicating foreign materials. In particular, they accounted for up to 10% of~     prosthetic joint infection (PJI), and are mostly identified in chronic forms of bone and~     joint infections (BJI). However, little is known about the pathophysiological pathway~     implicated in Corynebacterium BJI, species distribution and antimicrobial susceptibility, and~     the management of these difficult-to-treat clinical entities.~      This study aims to report a retrospective cohort of patients with Corynebacterium spp BJI,~     aiming to : i) describe microbiological characteristics of the implicated clinical isolates,~     including species identification and antimicrobial susceptibility (and especially according~     to previous antimicrobial exposure); ii) assess pathophysiological mechanisms associated with~     BJI chronicity, including biofilm formation and bone cell invasion, to better understand~     mechanisms of Corynebacterium spp and to evaluate their ability to distinguished colonizing~     and infective isolates; iii) describe the medical (nature and duration of antimicrobial~     therapy) and surgical management of these patients; and iv) evaluate the patient outcome~     according to this management strategy, and highlight risk factor for treatment failure in~     order to improve patient's management.~   "
37127|NCT03080649|"~     The aim of this study was to evaluate the excavation time, patients´ experiences, pulpal~     reactions and survival of fillings when carious tissue was removed with Er:YAG laser compared~     to rotary bur. A prospective, single-blind, randomized and controlled investigation was~     performed. Patients with at least two primary caries lesions radiographically assessed as the~     same size were recruited. In each patient one cavity was excavated with rotary bur and one~     with Er:YAG laser technique. The time requested for excavation and local anaesthesia were~     measured. The prevalence of postoperative symptoms, pulpal vitality and the quality of~     fillings will be investigated during two years after the excavation occasion.~   "
37237|NCT03079219|"~     The Olanzapine Regimen will be superior to the Standard Regimen, as measured by the~     proportion of patients with Complete Response in the 120 hours following AC chemotherapy.~   "
37080|NCT03081260|"~     Total knee arthroplasty is a frequent surgery in France. It currently represents 70,000~     interventions per year. The total knee prosthesis is also called tri-compartmental because it~     allows articulation between the femur and the tibia but also between the femur and the~     patella.~      The patella belongs to the extensor system. It articulates with the femoral trochlea in which~     it slides. It has an important biomechanical role on the quadriceps strength in addition to~     allowing flexion-extension movements.~      In the case of resurfacing, the joint face of the patella is cut off; A convex polyethylene~     implant is sealed with cement using studs on the same face.~      In case of non-resurfacing, the surgeon leaves in place the cartilage of the patella which~     will be in direct contact with the femoral prosthetic trochlea.~      Both methods have advantages and disadvantages. For some implants, it is recommended to~     resurface the patella because the implant is not very tolerant with the native patella. Other~     implants have been designed to be better adapted to the preservation of patellar cartilage.~      There is currently no evidence that one method is superior to the other on new generation~     implants known as patellar friendly.~      It seems necessary to compare both methods in terms of long-term postsurgery results.~   "
37081|NCT03081247|"~     This is a 12-week chronic-dosing study to assess the efficacy and safety of BGF MDI compared~     to BFF MDI in subjects with moderate to very severe COPD.~   "
37082|NCT03081234|"~     This is an international, multi-center, randomized, double-blinded, placebo-controlled~     clinical study evaluating the efficacy and safety of ribociclib with endocrine therapy as an~     adjuvant treatment in patients with hormone receptor-positive, HER2-negative, intermediate~     risk breast cancer.~   "
37083|NCT03081221|"~     The purpose of this study is to verification of Endotracheal Tube Placement with~     Ultrasonography (USG).~   "
37084|NCT03081208|"~     The primary objective of this study is to confirm the efficacy of a single oral 900mg dose of~     nolasiban to increase the ongoing clinical pregnancy rate at 10 weeks post embryo transfer~     (ET) day.~   "
37085|NCT03081195|"~     The objective of this research study is to examine the implementation of and outcomes~     associated with an evidence-based practice (EBP), specifically Multiple Family Group (MFG)~     targeting youth disruptive behavior challenges and success, through a scale up intervention~     study in Uganda, and two pilot studies that will be conducted in Kenya and Ghana~   "
37086|NCT03081182|"~     The Coordinating and Data Management Center (CDMC) at MD Anderson Cancer will be responsible~     for the coordination and data management for the Pediatric Longitudinal Cohort Study of~     Chronic Pancreatitis (INSPPIRE 2), which is part of the NIH U01 funded Consortium for the~     Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC). All patient~     recruitment will occur at external sites that are a part of the CPDPC. The data management~     systems, auditing, and monitoring effort are supported by the MD Anderson Cancer Center~     Clinical Research Support Center (CRSC).~   "
37087|NCT03081169|"~     This study compares the efficacy and complication rates of early (24 hours) versus late (72~     hours) VTE prophylaxis administration to TBI patients. Patients in both treatment groups will~     be monitored for development of VTE as well as complications from bleeding after commencement~     of VTE prophylaxis.~   "
37088|NCT03081156|"~     This trial is an investigator initiated study involving the use of the AstraZenica Aerophere~     Inhaler (Glycopyrrolate/Formeterol) to determine the effect on exercise tolerance and dynamic~     hyperinflation in patients with chronic obstructive lung disease.~   "
37089|NCT03081143|"~     This clinical trial will evaluate whether it is beneficial in terms of prolongation of~     survival to combine FOLFIRI (standard treatment) with ramucirumab compared to the standard~     treatment of ramucirumab plus paclitaxel in patients with advanced gastric cancer after~     failure of one prior line of palliative chemotherapy. This trial aims to investigate the~     efficacy and safety of ramucirumab plus FOLFIRI (investigational arm A) compared to~     paclitaxel plus ramucirumab (control arm B).~   "
37090|NCT03081130|"~     We will recruit 30 poor ovarian responders and thin endometrium patients, aged 35-45 year~     old, and treat with intravascular laser irradiation of blood (ILIB) via an intravenous~     catheter for irradiation of the blood under a period of 60 minutes for 10 days. We will~     evaluate the number and the quality of oocyte retrieved, endometrium thickness and pregnancy~     rate. The goal of the study is to evaluate whether ILIB is the efficient treatment to improve~     the ovarian response and the clinical outcome of the poor ovarian responders and thin~     endometrium patients.~   "
37091|NCT03081117|"~     Infection with HIV (the virus that causes AIDS) can lead to problems with brain function,~     such as memory, concentration, judgment, and the speed or control of hands and legs.~     Neurologists have called this condition HIV-associated neurocognitive disorder (HAND). This~     research is being done to see if insulin taken through the nose as a spray (intranasal~     insulin) can help people with HIV who are having problems with memory and brain function, or~     HAND.~      Participants will be given either insulin or placebo. A placebo is an inactive substance that~     looks like the study drug, but does not contain study drug. For this research study, the~     placebo will be a clear, saline-based liquid spray that looks like the insulin spray but has~     no insulin. Participants will not be told whether they receive insulin or placebo during the~     study.~      All participants will take the intranasal spray twice a day, about 30 minutes after a meal.~     Participants will use a specialized intranasal drug administration device. The total daily~     dose of insulin is 40 IU split between 20 IU in the morning and 20 IU in the evening.~     Participants will take the intranasal spray for 24 weeks.~      The researchers will record symptoms and side effects during the study. Procedures include~     neurocognitive testing of memory and brain function, two lumbar punctures (spinal taps),~     two MRI brain scans, several blood draws, and clinical assessments.~   "
37128|NCT03080636|"~     The present study compared the acute effects of Sex and exercise mode on subsequent blood~     pressure (BP) and heart rate variability (HRV) responses during daily work in healthy adults.~     All subjects did 3 sessions: aerobic exercise on a treadmill, resistance exercise at the gym~     and a seated control session.~   "
37129|NCT03080623|"~     This study proposed to construct an ultrasound-based diagnostic model for Differentiating~     Malignant Breast Lesion From Benign Lesion. This study contains both retrospective and~     prospective part, which are designed for model construction and independent validation,~     respectively.This study aims to construct an easy-to-use ultrasound-based model, prove the~     efficacy of the model for identifying malignant breast lesion from benign lesion, and finally~     promote the application of this diagnostic model in more clinics.~   "
37092|NCT03081104|"~     The intervention to be evaluated are operative hysteroscopy(group A) and ultrasound guided~     aspiration(group C) and blinded vacuum aspiration(group B).~      For all surgical procedures , surgical antibiotics prophylaxis, misoprostol to dilate cervix,~     and anti adhesion barrier gel will be used. The evacuated retention products will be sent for~     pathological examination.~      Group A: Operative Hystroscopy:~      The procedure will be performed under general anaesthesia with the patient in lithotomy~     position. the cervix is grasped with pozzi forceps and dilated up to hegar 9 to facilitate~     insertion of the hysteroscopy. The uterine cavity will be distended with saline or glycine,~     with a maximum irrigation pressure of 110mmHg. The retained products will be resected from~     top to bottom with surgical resector without electric power. The use of forceps or curettes~     to facilitate the removal of material is permitted. .~      Group B:blinded vacuum aspiration of gestational contents:~      The women were allowed to empty their urinary bladder before induction of anesthesia, After~     positioning the patient appropriately on the operating table, bimanual pelvic examination was~     performed under anesthesia to assess the axis and the size of the uterus. A Sim's speculum~     was inserted into the vagina; the cervix was visualized and grasped using the Vulsellum~     forceps. The cervical canal was dilated gradually with Hegar dilators up to the size~     corresponding to the weeks of gestation. The uterine cavity was evacuated using a plastic~     cannula attached to an electric suction apparatus. Negative pressure of 75 mmHg was used. The~     aspirate was examined to confirm the presence of products of conception. The completeness of~     the evacuation was checked by gentle sharp curettage and final suctioning at the end of~     procedure.~      Group C: Ultrasound guided aspiration curettage :~      same as group B but guided with ultrasound~   "
37093|NCT03081091|"~     Background: Chronic Widespread Pain (CWP) is a multidimensional disorder for which treatment~     as yet remains unsatisfactory. Acupuncture is one of the most sought therapeutic methods when~     it comes to alternative medicine, due to its minimal adverse effects and its ease of use in~     clinical practice. Currently, acupuncture is successfully used in China for the treatment of~     many chronic diseases. The work to be carried out aims to assess the effects of acupuncture~     on pain management and quality of life of people suffering from CWP.~      Methods/design: The study is a single-center, controlled triple-blind prospective study. A~     total of 100 participants will be randomly distributed into two groups, the intervention~     group, which will receive an individualized acupuncture treatment; and control group, which~     will receive sham acupuncture. The treatments performed will be personalized and the~     treatment criteria will be based on the use of the Yuan and Luo points. They will be~     evaluated using a specific measurement system, constituted of the Visual Analogue Scale, The~     Fibromyalgia Impact Questionnaire and The Medical Outcomes Study Sleep Scale. The primary~     outcome measures assess whether acupuncture can bring about a decrease in pain and an~     improvement in the quality of life of people suffering from chronic widespread pain; the~     secondary outcomes assess whether the use of acupuncture leads to improved sleep quality. The~     results obtained will be analysed at 1st, 4th and 8th weeks from the start of treatment.~      Discussion: This technique is aimed to restore some of the imbalances suffered by patients~     affected with CWP and to improve their symptomatology. We expect to observe a significant~     improvement in the pain, quality of life and sleep quality of people affected with CWP. The~     study will be conducted according to the STRICTA guidelines, which lay down the right way to~     proceed when carrying out scientific studies in the field of acupuncture.~   "
37094|NCT03081078|"~     The study will determine whether community-based caring contact via a mobile app connection~     with or without volunteer support in addition to treatment as usual (psychiatric and~     psychosocial treatments) has an effect on suicidal ideation and treatment compliance among~     post-discharge self-harm young adults.~   "
37095|NCT03081065|"~     OBJECTIVES:To assess the effect of the intervention with Mediterranean Diet (MD) supplemented~     with extra virgin olive oil (EVOO) or tree nuts (TN) during 2 years (compared to a control~     group without intervention) on the risk of recurrence of unipolar depressive disorder in~     patients with partial or total remission for unipolar depressive disorder (1). Differences~     between groups in changes in residual symptoms (2), quality of life (QL) (3), biochemical~     parameters (4) and in the risk of medical/psychiatric co-morbidities (5) will be also~     analyzed. Finally, gut microbiota and its changes will be collected and compared between~     groups (6). METHODS: Multicenter clinical trial with 3 arms of intervention (MD+EVOO;~     MD+TN;control) during 2 years. Adults with previous episodes of unipolar depressive disorder~     in partial or total remission stage (determined through Montgomery-Asberg questionnaire and~     MINI interview) will be included. Participants with current depression, psychiatric co-morbid~     disorders or with problems to follow dietary recommendations will be excluded. A recurrence~     ratio of 35% in the MD groups and of 50% in the control group will be considered (Hazard~     Ratio: 0.7). We estimate a sample size of 720 participants (750 to count for losses) (90%~     power and 5% alpha error). Intervention will be performed through postal mail (recipes and~     information), email, phone y new technologies (Web page/mobile app) with periodic contacts~     with psychiatrics and dieticians and postal mail for free EVOO and nuts supply. Information~     from participants will be gathered with validated questionnaires of diet, physical activity,~     QL, or symptoms using postal mail, email, Web page or the phone. The analyses will be~     performed by intention to treat.~   "
37096|NCT03081052|"~     The primary purposes of this study has 2 aims. First, to conduct a clinical investigation to~     determine if iEPO, Veletri® will have similar efficacy in pulmonary vasodilation and have a~     similar impact when compared to iNO, INOMAX® in adult patient who undergo a heart~     transplantation, lung transplantation or implantation of a left ventricular assist device .~     Second, to conduct a cost-capture analysis on the expense each drug incurs per patient.~   "
37097|NCT03081039|"~     Compare the efficacy of adjuvant chemotherapy with Cisplatin or Carboplatin and Gemcitabine~     versus Gemcitabine in patients with resected or ablated intra-hepatic cholangiocarcinoma.~   "
37098|NCT03081026|"~     To assess the risk of lower extremity angular growth deformity following anterior cruciate~     ligament (ACL) reconstructions in young patients who are not yet skeletally mature. The study~     will compare two surgical techniques (physeal sparing vs transphyseal).~   "
37099|NCT03081013|"~     The study aims:~        1. To test the effect of providing social comparison information on increasing physical~          activity among Singaporean adolescents.~        2. To test whether providing social comparison information increases physical activity more~          when it is provided publicly compared to when it is provided anonymously.~   "
37100|NCT03081000|"~     Aims:-~      Primary:~      To identify the incidence of intra-operative and post-operative hypothermia~      Secondary:~      To identify factors contributing to peri-operative hypothermia. To identify current~     anaesthetic practice in peri-operative temperature monitoring, use of active/warming measures~     by anaesthetists in various hospitals.~      To increase awareness of the problem of IPH and guidelines available.~   "
37101|NCT03080987|"~     The primary purpose of this study is to assess the safety and tolerability of JNJ-64179375 in~     Part 1 and 2.~   "
37102|NCT03080974|"~     Compare the efficacy and tolerability of irreversible electroporation in combination with~     Nivolumab in patients with locally advanced pancreatic cancer.~   "
37130|NCT03080610|"~     Spinal anesthesia is commonly used for cesarean section.However, the procedure is still have~     some adverse events such as high spinal block, nerve injuries or postdural puncture headache~     (PDPH).This is a potential complication of neuraxial anesthesia in clinical practice.~      The investigators are curious regarding factors determining the incidence of postdural~     puncture headache in parturients undergoing cesarean section after epidural blood patch.~   "
37103|NCT03080961|"~     Genital herpes has a high prevalence in industrialized as well as developing countries.~      Genital herpes causes genital ulcers, increases risk for acquiring HIV infection, and may be~     transmitted mother to child during birth with possible serious consequences.~      Medical treatments and condoms only partially reduce the risk for transmission from/ to~     sexual partners. Genital herpes transmission despite use of condoms is thought to be due to~     transfer via skin-to-skin contact in unprotected areas, and HSV-2 transmission may be~     enhanced by current shaving habits in the genital area leading to micro lesions (lacerations)~     of the skin.~      VIBLOK™ is a cream designed to impede the passage of viruses, such as HSV-2, across the skin.~     Bench and animal experiments indicate that it can block virus transmission such as HSV-2 over~     80%.~      The objective of the SAFE trial is to assess the safety and performance of VIBLOK in adults~     with HSV-2 infection by comparing virus detection in the extra-genital area before and after~     application of the barrier cream.~   "
37104|NCT03080948|"~     The investigators are doing this study to improve our ability to identify which people with~     many moles on their skin are most likely to develop skin melanoma. The investigators hope to~     identify features of moles that are associated with melanoma risk. The investigators hope to~     use this information to customize and tailor melanoma screening to the individual patient~     based on a better estimate of their individual risk.~   "
37105|NCT03080935|"~     This is a multicenter, open-label extension (OLE) study designed to assess the extended~     long-term safety of evolocumab in subjects who have completed the FOURIER trial (Study~     20110118). Approximately 1600 subjects will be enrolled in this study. This study will~     continue for 260 weeks (approximately 5 years).~   "
37106|NCT03080922|"~     The purpose of this study is to evaluate the safety and efficiency of high dose allogeneic~     mismatched hematopoietic stem cells infusions after normal chemotherapy in patients with~     relapsed/refractory acute myeloid leukemia（AML）.~   "
37107|NCT03080909|"~     A double-blind, randomized crossover design with five arms including four experimental~     conditions and placebo will be applied. After having successfully completed screening~     procedures, eligible participants will be invited to five separate test days. The test days~     cannot be within the same week, however there is no upper limit for days in between, as long~     as the participants remain weight stable and do not change diet or physical activity level.~     Significant changes in diet, physical activity level (evaluated by the sub-investigator) or~     weight change ±3 kg over the course of the study (from screening to completion of the last~     test day) results in exclusion of that subject.~   "
37108|NCT03080896|"~     Using a combination of the video-laryngoscope with the disposable fiber-optic bronchoscope~     (aScope III) is a feasible way to facilitate successful intubation in a timely manner, in~     patients with predicted difficult airway due to tumors in the oral cavity, pharynx or larynx~     To test the hypothesis that combination of video-laryngoscope with the fiber-optic~     bronchoscope is superior to video-laryngoscope alone for intubation of patients with oral~     cavity, pharyngeal or laryngeal pathologies undergoing surgery~   "
37109|NCT03080883|"~     This randomized phase III trial studies the best dose of apixaban and how well it works in~     preventing secondary cancer related blood clots in cancer patients who have completed~     anticoagulation therapy. Apixaban may stop the clotting of blood by blocking some of the~     enzymes needed for blood clotting.~   "
37110|NCT03080870|"~     Music, dance and visual arts are suggested to support health and well-being of older people.~     Intervention studies, however, are scarce. JOY of ART study investigates the effects of~     multicomponent art intervention among older people and ther family caregivers.~   "
37111|NCT03080857|"~     This will be a before-after study, using a prospective cohort to evaluate the use of a~     virtual, patient-centered platform as compared to a historical cohort of patients with atrial~     fibrillation (AF) and if the education and support provided by the platform will reduce~     Emergency Department visits for AF.~   "
37112|NCT03080844|"~     The purpose of this research study is to help determine whether practicing resisting the urge~     to smoke changes brain function or behavior among smokers.~   "
37113|NCT03080831|"~     Prospective randomized double blind phase IV trial studying the efficacy and safety of the~     tonicity of two different perioperative maintenance solutions: an isotonic solution~     containing NaCl 0.9 in glucose 5% with an added 40 mmol/L of potassium or a commercially~     available premixed solution (Glucion 5%) containing a.o. 54 mmol/L of sodium and 26 mmol/L of~     potassium. Both solutions are administered at 27 mL/kg of ideal body weight, as recommended~     by current guidelines (NICE 174) and both solutions are widely used in daily clinical~     practice. The primary hypothesis is that isotonic maintenance solutions lead to more fluid~     retention than hypotonic fluids. Metabolism of both solutions is assessed by sequential~     analysis of urine and serum and clinical parameters.~   "
37114|NCT03080818|"~     This study will determine whether supplementation of probiotic Lactobacillus Rhamnosus GG~     improves psychological status in middle age and older adults through a 12-week, randomized,~     double-blind, placebo-controlled clinical trial. Secondary analyses will be conducted to~     examine the possible benefits of probiotic supplementation on cognitive function and markers~     of physical health.~   "
37115|NCT03080805|"~     Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This~     study is a randomized,open-label,multi-center,active-controlled, parallel design study of the~     combination of pyrotinib and capecitabine versus Lapatinib plus capecitabine in HER2+ MBC~     patients, who have prior received taxane and trastuzumab.Patients will be randomized in a 1:1~     ratio to one of the following treatment arms.Arm A: pyrotinib (400 mg once daily) +~     capecitabine (1000 mg/m^2 twice daily),Arm B: Lapatinib (1250 mg once daily) + capecitabine~     (1000 mg/m^2 twice daily).Patients will receive either arm of therapy until disease~     progression, unacceptable toxicity, or withdrawalof consent.~   "
37116|NCT03080792|"~     The PRESENT-P study is a one-arm exercise intervention study for hematological cancer~     patients prior allogeneic stem cell transplantation (allo-HCT). This pilot study will~     investigate in a prehabilitation approach the safety and feasibility of high-intensity~     exercise program directly prior transplantation.~   "
37131|NCT03080597|"~     The investigators' overall goals are to target (a) pre-exposure prophylaxis (PrEP) uptake by~     addressing access and acceptability and (b) PrEP adherence among Historically Black Colleges~     and Universities (HBCU) students.~   "
37117|NCT03080779|"~     Post Dural Puncture Headache (PDPH) causes significant short-term disability, prevents~     mobilisation, affects childcare activities and results in prolonged hospital stay. Initial~     treatment involves painkillers and if patient fails to respond, an Epidural Blood Patch~     (EBP). EBP involves taking patient's blood and injecting into the epidural space. It is~     generally agreed that PDPH is a self-limiting condition and resolves in two weeks. However~     there is emerging evidence that patients with PDPH could be at an increased risk of~     developing longstanding (chronic) headaches. Retrospective case studies show that between 28~     - 34% of patients who developed PDPH had longstanding headaches at 18 months after the~     insertion of the epidural. There is also recent evidence of new onset low back pain~     developing in patients who have received an epidural blood patch that was performed to treat~     PDPH. Nearly two thirds of patients from a hospital in UK had new onset low back pain after~     they had received epidural blood patch treatment. Presently, there is no prospective clinical~     study evaluating the development of longstanding headaches and new onset low back pain after~     the development of PDPH. Aim of the present study is to evaluate the incidence of~     longstanding headache after accidental dural (ADP) puncture and the incidence of new onset~     low back pain after epidural blood patch treatment.~   "
37118|NCT03080766|"~     Acute myeloid leukemia (AML) is a heterogeneous group of diseases with distinct~     clinicopathologic features sharing in common an abnormal increase in myeloblasts in blood and~     bone marrow (BM). In about 5-10% patients, the myeloblasts exhibit chromosomal abnormalities~     (complex and/or monosomal karyotype, CK/MK*) that are associated with refractoriness to~     conventional chemotherapy and an extremely bad prognosis.~      Standard induction chemotherapy for AML comprises daunorubicin and cytarabine, the 7+3~     regimen. However, treatment is largely ineffective for CK/MK AML with a temporary clearance~     of blasts achieved in only 30-40% cases and the cumulative toxicities resulting from repeated~     courses of chemotherapy have significantly increased the morbidity and mortality risks in~     subsequent allogeneic BMT. Therefore, standard treatment is unsatisfactory and there is an~     unmet clinical need for more effective and less toxic induction regimen.~      Both previous and recent studies showed that 10 day course of decitabine (20 mg/m2/day)~     induced remission in 70-100% patients with CK/MK AML, particularly those with TP53 mutations.~     In this study, patients with CK/MK AML will be treated with decitabine to induce remission.~     Bone marrow examination will be performed after each course until complete clearance of~     blasts or disease progression. Patients achieving CR/CRi (see below) will continue to receive~     4 more courses, after which patients eligible for BMT and for whom donors are available will~     receive curative BMT. We reckon that the time it takes for 4 courses of decitabine will~     suffice for transplantation workup in HK. . Patients ineligible for BMT will continue to~     receive decitabine until leukemia progression. The response rate, leukemia free survival~     (LFS), overall survival (OS) and percentage of patients who can be bridged to BMT will be~     compared with historical 7+3 regimen control.~   "
37119|NCT03080753|"~     The purpose of this study is to determine whether treatment with intersphincteric implants is~     an effective and safe treatment option for patients with anal incontinence~   "
37120|NCT03080740|"~     Randomized, double blind, positive drug parallel comparison, multi-centre clinical trial to~     assess the Efficacy and Safety of Clindamycin palmitate hydrochloride dispersible tablet for~     the treatment of bacterial vaginosis~   "
37121|NCT03080727|"~     The functional assessment of the hip joint is complex and challenging. Reproducible measures~     are necessary to identify changes in the structures and functionality of the hip joint over~     time and to evaluate the outcomes of treatments. A systematic evaluation process is critical~     to evidence-based practice. However, there are few studies investigating the reproducibility~     of these measures such as muscle strength, range of motion (ROM) and hip functionality in~     healthy subjects.~   "
37122|NCT03080714|"~     To Compare the agreement and precision between the Topcon DRI OCT Triton and the 3D OCT-1~     Maestro with RDB.~   "
37123|NCT03080701|"~     The investigators propose to build on the success of the Systems of Support to Increase~     Colorectal Cancer trial (SOS, R01CA121125, Green) and focus on disparity groups who are less~     likely to be current for colorectal cancer (CRC) screening. We will test whether financial~     incentives increases screening uptake and decreases screening disparities. The investigators~     hypothesize that CRC screening rates will be higher in patients offered mailed fecal kits and~     financial incentives than those offered mailed fecal kits alone.~   "
37124|NCT03080688|"~     This study is intended to evaluate performance of the new design sufficiently to support~     performance claims for an FDA 510K submission or ISO technical file. Specifically:~        -  SpO2 value range 70% to 100%~        -  10 or more subjects, at least 3 of dark pigmentation~        -  At least 200 data points~        -  Meeting the following test required by the 2013 FDA Guidance on Pulse Oximeters -~          Premarket Notification Submissions and by ISO 80601-2-61 on Pulse Oximeters:~        -  2013 FDA Guidance on Pulse Oximeters - Premarket Notification Submissions:~             -  4.1. ACCURACY OF PULSE OXIMETERS~             -  4.1.1 IN VIVO TESTING FOR SPO2 ACCURACY UNDER LABORATORY CONDITIONS~        -  ISO 80601-2-61:2011 Annex EE.2 and clause 201.12.1.101.2~             -  201.12.1.101 SpO2 accuracy of pulse oximeter equipment~             -  201.12.1.101.2 Determination of SpO2 accuracy~   "
37125|NCT03080675|"~     To show the efficacy of a 4-year intervention with nutritional blend of ingredients to~     prevent cognitive decline.~   "
37126|NCT03080662|"~     The impact of the reduction of daily physical activity (DPA) in patients with COPD (chronic~     obstructive pulmonary disease) is a highly studied area, due to its impact on the quality of~     life and the clinical evolution of the disease . This fact has multifactorial components: its~     function is naturally diminished with time, and its effects on the loss of physical condition~     (decondition). However, dynamic hyperinflation and respiratory muscular dysfunction,~     especially in patients with more symptomatology, have been identified as those that have the~     most relevant factors that impact on daily physical activity Due to the detrimental effects~     of the pulmonary hyperinflation, the diaphragm is flatter and shorter, being in a position of~     mechanical disadvantage. This contributes to a reduced effort capacity and increase in the~     dyspnea of patients during daily activities.~      Resistance training improves their exercise capacity and reduces dyspnea, however it does not~     improve inspiratory muscle strength. It is for this reason, that specific training of the~     inspiratory muscles, offers special interest in patients with decreased inspiratory muscle~     strength and pulmonary hyperinflation.~   "
37132|NCT03080584|"~     the investigators want to study whether 12 weeks of acupuncture has any effect on AMH and the~     ovarian reserve in women with low ovarian reserve (low responders). AMH is measured before~     and after 12 weeks of acupuncture and the clinical response to controlled ovarian~     hyperstimulation before and after the acupuncture is compared.~   "
37238|NCT03079206|"~     The proposed study intends to compare the outcome of food challenge in hazelnut allergic~     patients with the outcome of basophile activation tests using hazelnut extract and~     components.~   "
37133|NCT03080571|"~     Stroke is a leading cause of morbidity and mortality.Acute ischemia causes irreversible~     damage to neurons and glial cells, leading to functional deficits and chronic sequelae with~     variable degrees of spontaneous recovery of function. Stem cells have been shown to enhance~     recovery through multiple immunomodulatory effects, neoangiogenesis and neurogenesis.~      We conducted a prospective randomised end observer blinded study to evaluate primarily the~     safety of intraarterial autologous stem cells delivered to ipsilateral middle cerebral artery~     in acute and subacute stroke patients (0-15 days post ictus).Secondarily we aimed to evaluate~     the outcome on the basis of clinical evaluation and follow up imaging~   "
37134|NCT03080558|"~     Indocyanine green is a dye, using in surgery to bring out the intraoperative evaluation of~     tissue perfusion.~      After intravenous injection of indocyanine green, using a near infrared light, the~     vascularisation becomes fluorescent.~      In endometriosis disease, the treatment of recto vaginal node can be complicated by~     rectovaginal fistula.~      An abnormal vascularisation related to the surgery would be a risk factor of post operative~     fistulas.~      The aim of this study is to evaluate the rectal and vaginal vascularisation during the~     treatment of a recto vaginal endometriosis nodule with rectal shaving, using indocyanine~     green fluorescence.~   "
37135|NCT03080545|"~     Patients receiving biologic therapy with 5% or less body surface area will receive Enstilar~     topical foam for 16 weeks.~   "
37136|NCT03080532|"~     Despite the strong evidence on health benefits of traditional MeD, not many studies have~     broadly and systematically been made for the potential role and relationship of the MeD in~     the composition of the gut microbiota.~      Furthermore, little is known about the composition of the gut microbiota in individuals with~     defined dietary habits on the Mediterranean pattern.~      This work is aiming at comparatively studying the gut microbiota of three different dietary~     oriented european populations. In particular, biological samples and related information will~     be collected from populations with high adherence to Mediterranean diet (MeD) in Crete -~     Greece and Molise region - Italy. These data will be comparatively assessed with those~     provided by a sample population with high adherence to Western diet in Auvergne - France.~   "
37137|NCT03080519|"~     A multicenter prospective registry planned to recruit more than 5 000 patients with renal~     artery stenosis was carried out in China. This primary purpose of this study was to evaluate~     the safety and efficacy of renal artery revascularization in the real world. The secondary~     purpose was to investigate the etiologic distribution of renal artery stenosis and optimize~     the indications for renal artery revascularization.~   "
37138|NCT03080506|"~     Cesarean delivery is a common obstetrical procedure and is associated with increased maternal~     morbidity and mortality. Pain and limited mobilization are major contributing factors that~     result in delayed functional recovery and complications. Elastic abdominal binder, a wide~     elastic belt that is wore around the patient's abdomen to support surgical incision after~     surgery, has been employed by clinicians for pain relief, wound complications prevention,~     improved pulmonary function, and stabilization. Benefits of the abdominal binder use have not~     been properly examined.~      The aim of this study is to examine the effect of postcesarean elastic abdominal binder use~     on recovery by comparing pain scores and mobility function (through the 6-minute walk test~     [6MWT]) in postcesarean mothers who use versus do not use the elastic abdominal binder to~     support incisional site.~   "
37139|NCT03080493|"~     Women having abortion procedures between 15 weeks 0 days and 23 weeks 6 days gestational age~     on the day of their procedure commonly have dilators placed in their cervix overnight before~     the abortion procedure. The dilators are put in during a pelvic exam in the clinic and after~     women go home they expand slowly overnight to open the cervix before the abortion procedure~     the next day. This can be a painful experience and health care providers often give women~     different kinds of pain medicine to help them.~      The investigators are interested in whether a medicine called gabapentin, which is a~     non-narcotic medicine, could help. Gabapentin is approved by the U.S. Food and Drug~     Administration (FDA) for prevention of seizures and for treating nerve pain and doctors are~     also using it to decrease pain for people having surgical procedures.~      The main goals of our study are to learn about:~        1. Women's pain experience with dilators in their cervix overnight before the abortion~          procedure~        2. How well gabapentin works to decrease women's pain while they have the dilators in their~          cervix~      Women who enroll in the study will get a dose of either gabapentin or placebo (a pill with no~     medicine in it) before their dilators are placed in the clinic. The medication they get~     (gabapentin or placebo) will be chosen by chance, like flipping a coin. Neither the women in~     the study nor the doctors giving them the medication will know which medication they receive~     so the investigators can learn about their pain without being influenced by knowing which~     medication they take. Doctors will be able to find out which medication women got if there is~     an emergency or if it changes their medical care.~      The investigators will communicate with women in real time overnight by text messaging to see~     how much pain they are having in the moment and how much pain medicine they are taking.~      The investigators hypothesize that women who receive gabapentin will have a smaller increase~     in their pain with the dilators than women who receive placebo (a pill with no medicine in~     it).~      The investigators' findings will help doctors understand women's pain experience with~     dilators better and possibly provide a new way of treating pain with gabapentin.~   "
37140|NCT03080480|"~     The purpose of this proposed research is to investigate the efficacy and safety of the~     therapy with pioglitazone for chronic granulomatous disease (CGD) patients severe infection.~   "
37141|NCT03080467|"~     This project is an observational trial investigating wound cosmetic appearance after repair~     of traumatic skin lacerations in the head area of pediatric patients with two different~     approaches to skin closure: sutures versus tissue adhesive. Photographs will be taken at two~     follow-up visits after repair and later assessed by external blinded plastic surgeon using~     standard cosmetic assessment scales. The investigators hypothesize that cosmetic wound~     outcome will be equivalent in these two wound repair treatment options.~   "
37142|NCT03080454|"~     The purpose of this study is to evaluate if 5 consecutive sessions of PathMaker DoubleStim~     treatment, which combines non-invasive stimulation of the spinal cord (tsDCS- trans-spinal~     direct current stimulation) and of the median nerve at the peripheral wrist (pDCS--~     peripheral direct current stimulation), can significantly reduce spasticity of the wrist and~     hand after stroke.~   "
37143|NCT03080441|"~     This is a research study to test the application of FDA-approved, non-invasive device (NICaS)~     that measure the performance of your heart during HD treatment.~   "
37157|NCT03080259|"~     The purpose of this study is to test clinical strategies that pediatric providers may use to~     prevent misuse and diversion of stimulants by their adolescent patients with ADHD.~   "
37158|NCT03080246|"~     The purpose of this study is to look at the effect of strength training in preventing overuse~     injuries in female runners~   "
37239|NCT03079193|"~     Post thyroidectomy laryngeal nerve injuries are frequently encountered specially in total and~     near total thyroidectomy some unilateral injuries are not clinically evident and~     asymptomatic.~      The aim of this study is to compare mandatory versus selective post-thyroidectomy endoscopic~     examination of larynx to detect laryngeal nerve injuries.~   "
37144|NCT03080428|"~     The need/benefit of adjuvant chemotherapy could be negligible for a certain category of~     patient with newly diagnosed unilateral non metastatic breast cancer. Physicians are~     sometimes divided between the administration of adjuvant treatment and no administration when~     the risk of distant relapse at 10 years is around 10% with uncertainty and a theoretical~     benefit of chemotherapy is less than 5% at 10 years according to guidelines in use in the~     center.~      Several genomic tests have been developed this last decade. These tests use a sample of~     breast cancer tissue to analyze the activity of a group of genes. Knowing whether certain~     genes are present or absent, overly active or not active enough, can help physicians predict~     the risk of recurrence.~      In addition to standard pathological characteristics, a genomic test could be helpful in~     making treatment decisions, such as whether or not chemotherapy should be part of the~     treatment plan. First generation prognostic tests are currently widely used worldwide to~     guide decision making regarding adjuvant chemotherapy (OncotypeDX™ Mammaprint®). Prognostic~     tests have reached a level of evidence 1A, with the results of the prospective randomized~     trial Mindact. In the Mindact trial, among women with early-stage breast cancer who were~     at high clinical risk and low genomic risk for recurrence, the receipt of no chemotherapy on~     the basis of the 70-gene signature led to a 5-year rate of survival without distant~     metastasis that was 1.5 percentage points lower than the rate with chemotherapy. Given these~     findings, approximately 46% of women with breast cancer who are at high clinical risk might~     not require chemotherapy. The health-economic value of such signatures in the general~     population of patients with localized breast cancer appears very low at current costs.~      Meanwhile, next generation prognostic signatures have been developed that have integrated~     clinical parameters and suggest high added value beyond all standard and traditional~     characteristics including tumor burden, grade, Estrogen Receptor (ER) and Progesterone~     Receptor (PR), Her2, age and also standard assessment of proliferation.~      In this study, the clinical utility of genomic tests (Endopredict®, Prosigna®, OncotypeDX®,~     Mammaprint® assay) defined as impact on chemotherapy decision in the adjuvant setting in~     patients with ER-positive, Her2-negative early breast cancer with uncertainty on the~     indication of chemotherapy using standard assessments will be compared.~   "
37145|NCT03080415|"~     This is an open, uncontrolled pilot study of thirty chronic HCV infected patients carried out~     at Yassin Abdel Ghaffar Charity Center for Liver Disease and Research. The aim of this study~     is to investigate the safety & efficacy of combined therapy sofosbuvir (SOF) and daclatasvir~     (DCV) for treating HCV Genotype 4 in children aged 8 to 18. Due to previous positive results~     in other clinical studies of this drug it is expected that the drug will have high safety and~     high efficacy. Safety will be measured by checking for adverse effects, while efficacy will~     be measured by Real-Time Quantitative Polymerase Chain Reaction (qPCR) detecting viral~     nucleic acids in blood samples.~   "
37146|NCT03080402|"~     A prospective trial will be used to evaluate the efficacy of prophylactic mechanical~     perturbation training program. 24 female athletes who are regular participants in activities~     that involve cutting, pivoting, jumping, and lateral movements prior to injury who range in~     age from 15-30 year are eligible. Using a prospective risk stratification design, female~     athletes with knee abduction moment (KAM) > 25.25 Nm from drop jump motion analysis will be~     classified as high KAM and will receive 12 sessions of mechanically-driven perturbation~     training and female athletes with KAM < 25.25 Nm from drop jump motion analysis will be~     classified as normal KAM and only participate in baseline performance testing, followed 6~     weeks later by another session of drop jump motion analysis and performance testing.~   "
37147|NCT03080389|"~     There is some evidence to suggest standard urine cultures may not be adequate in identifying~     patients with low grade urinary tract infections. Therefore, there are patients with symptoms~     of frequency and urgency, being misdiagnosed with overactive bladder due to negative urine~     cultures. If this is true, could extended cultures be used to identify the false negative~     patients?~   "
37148|NCT03080376|"~     Aim: To evaluate the impact of a physical exercise Web-based program with or without support~     on body composition, physical fitness and blood pressure values.~      Design: Randomized Controlled Trial. Population: Obese children and adolescents.~   "
37149|NCT03080363|"~     Extracorporeal shockwave lithotripsy (ESWL) is widely used for the treatment of urinary tract~     calculi; however, the vast majority of patients do not tolerate the procedure without~     analgesia and sedation.~      Lots of methods have been tried to control this pain (non-steroidal anti-inflammatory drugs,~     opioids, alpha 2 agonists, transversus abdominis plane block with long-acting local~     anesthetics, paravertebral block, local anesthetics infiltration, lidocaine/prilocaine~     cream).~      The quadratus lumborum block was first described by Blanco. QL block is performed as one of~     the perioperative pain management procedures for abdominal surgery. QL block provides~     anesthesia and analgesia on the anterior and lateral wall of the abdomen.~   "
37150|NCT03080350|"~     The purpose of this study is to determine the non-inferiority of the efficacy for prehospital~     analgesia of sublingual administered fentanyl versus endovenous administered fentanyl for~     patients with limb trauma on the slope~   "
37151|NCT03080337|"~     This study aims to use an innovative and integrated educational curriculum to deliver~     prenatal care and diabetes care for pre-gestational diabetic women from approximately the~     first trimester of pregnancy through delivery and the early postpartum period in a group care~     model. The group care model will be compared to a control group, a traditional, individual~     care model.~   "
37152|NCT03080324|"~     The purpose of this study is to determine the non-inferiority of the efficacy of sublingual~     given fentanyl versus endovenous given fentanyl for patients in the emergency departement.~   "
37153|NCT03080311|"~     APG-1252 is a highly potent Bcl-2 family protein inhibitor, a promising drug candidate which~     shown high binding affinities to Bcl-2, Bcl-xL and Bcl-w. The preclinical studies have shown~     that APG-1252 alone achieves complete and persistent tumor regression in multiple tumor~     xenograft models with a twice weekly or weekly dose-schedule, including SCLC, colon, breast~     and ALL cancer xenografts; achieves strong synergy with the chemotherapeutic agents,~     indicating that APG-1252 may have a broad therapeutic potential for the treatment of human~     cancer as a single agent and in combination with other classes of anticancer drugs. APG-1252~     is intended for the treatment of patients with SCLC or other solid tumors. Upon completion of~     the Phase 1 dose escalation study to establish the maximum tolerated dose (MTD),~     dose-limiting toxicities (DLTs), and/or recommended phase 2 dose (RP2D), several phase Ib/II~     studies will be implemented accordingly.~   "
37154|NCT03080298|"~     This is study of the efficacy, safety and pharmacokinetics of BP101 compared to placebo in~     patients with a decrease or loss of sexual desire.~   "
37155|NCT03080285|"~     This is a study to investigate efficacy of over-glasses patch treatment for amblyopic~     children using visual function improvement and Amblyopia Treatment Index (ATI) changes.~   "
37156|NCT03080272|"~     With this study the investigators want to perform a prospective cross-sectional audit at~     Zealand University Hospital, Koege, Denmark. The aim is to investigate the actual pain~     treatment and outcomes from a representative number of surgical procedures from different~     surgical departments.~   "
37159|NCT03080233|"~     This is a observational validation study. The Stroke Clinical Decision Support Tool (~     InstaDx) , an information technology application will be adapted and developed in accordance~     to evidence based clinical practice guidelines ( Level IA). Neurology Residents will be using~     the InstaDx CDST to improve their diagnostic accuracy and the findings will be validated~     against the review of a stroke subject expert. The study hypothesis is that Clinical Decision~     Support Tool used by neurology residents will have an agreement of >0.77 when compared to~     Stroke Expert (gold standard) in diagnosing type of ischemic stroke.~   "
37160|NCT03080220|"~     The purpose of this study is to investigate the effects of Astym® treatment, The Stick®~     treatment and massage treatment on performance among healthy college athletes and to~     investigate any relationship between functional movement and functional performance.~     Participants will be recruited from Division II, National Association of Intercollegiate~     Athletics (NAIA) basketball and volleyball teams. The participants will be randomized into~     one of three groups: Astym treatment (AT), The Stick treatment (ST) or massage treatment~     (MT). The participant will have baseline measures of vertical jump (VJ), Y-Balance Lower~     Quarter Screen (YBLQ), and a rating of current perceived lower extremity function using a~     visual analog scale (PLEF-VAS). The participants will be treated using either the AT, ST, or~     MT following baseline measures. Immediately following the intervention, a second measurement~     of VJ, YBLQ, and PLEF-VAS will take place. The data will be analyzed using mixed ANOVA tests~     which will be conducted for each dependent variable. In addition, functional movement is~     thought to be related to functional performance. A Pearson Product Correlation analysis will~     be used to understand any relationship between YBLQ and VJ. It is hypothesized that those in~     the AT group will have different percent change in their YBLQ, VJ, and PLEF-VAS compared to~     those in ST and MT groups. It is hypothesized that a correlation between YBLQ and VJ will~     exist. As a result, clinicians could use AT among basketball and volleyball athletes without~     hindering acute performance. Any risks the participants could encounter are minimal.~     Participants may withdraw themselves and their data at any time. The intervention and testing~     are similar to what an athlete would be exposed to during their collegiate career. Any~     participant injured during this study will be referred to their university sports medicine~     staff, health center, or the Indiana Wesleyan University health center.~   "
37161|NCT03080207|"~     At the end of the study, comparative information about the effects of PRP, complex~     decongestive physiotherapy and low level laser on edema volume, range of motion, muscle~     strength, functional capacity and quality of life will be obtained in the treatment of~     patients with lower limb lymphedema.~      Since there is no study about this field in the literature, this study will provide new and~     valuable contributions about treatment of lower extremity lymphedema for the researchers and~     clinicians.~   "
37162|NCT03080194|"~     This is a 12-month open-label randomized controlled study. Patients with schizophrenia and~     violence risk under the government supervision will be enrolled in the study. A~     community-based long-acting antipsychotics-treated management model will be applied to the~     experimental group, which means that professional psychiatrists will provide guidance to~     primary-level mental health workers on the psychotic treatment, and monthly-injected~     long-acting antipsychotic, paliperidone palmitate, will be used in the schizophrenia~     treatment. Every subject in experimental group will be equipped with an intelligent robot~     capable at push-to-talk and push-to-view, allowing the patients and caregivers to contact~     doctors for assistance at any time.~      The subjects in experimental group will be injected with 150mg eq and 100mg eq paliperidone~     palmitate in the deltoid at the 1st and 8th day, and afterwards a flexible dose of~     paliperidone palmitate from 75 to 150mg eq will be administrated monthly according to~     clinical judgement.~      Subjects in control group will be treated with oral antipsychotics or other conventional~     medication.~   "
37163|NCT03080181|"~     Background: Pasireotide treatment is strictly associated with glucose metabolism impairment.~     The aim of the study was to evaluate the effect of pasireotide on β -cell and adipose~     function in patients with Cushing's disease (CD).~      Methods: Clinical and hormonal parameters, insulin secretion, evaluated by homostasis model~     assessment (HOMA-β) and by the area under the curve (AUC2h) of C-peptide during a mixed meal~     tolerance test and insulin sensitivity, evaluated by the euglycemic hyperinsulinemic clamp,~     were evaluated in 12 patients with active CD before and after 12 months of pasireotide.~      Circulating adipokines were evaluated in patients with CD compared to a matched group of 12~     diabetic patients.~   "
37164|NCT03080168|"~     This is a research project looking at whether measuring movements or responses to certain~     questions can help predict suicidal thoughts or actions.~      This project has two parts: The first part will occur while the participant is receiving~     hospitalized at the Bedford VA Hospital. It involves wearing a watch-like device on his/her~     wrist and answering questions or doing tasks to measure mood and other mental health~     symptoms, and suicidal thoughts.~      In the second phase, the investigators will call the participant around 12 months after s/he~     has left the hospital. The investigators will discuss how s/he is doing and if s/he has had~     suicidal thoughts or made suicidal acts.~   "
37165|NCT03080155|"~     The purpose of the study is to assess the effectiveness of MIRA in classifying women with~     dense breast tissue for supplemental breast MRI. To assess the effectiveness of MIRA for~     correctly classifying women with breast cancer and to evaluate the safety of the device.~      In women above 30 years old who are undergoing MRI or are scheduled for image-guided needle~     biopsy due to lesions detected by other imaging modalities.~   "
37166|NCT03080142|"~     This is a prospective randomized study designed to compare the pain control from a single~     shot of liposomal bupivacaine (Exparel) against transversus abominus plane (TAP) catheters~     with ropivicaine bolus in patients undergoing elective colorectal surgery.~   "
37167|NCT03080129|"~     Protein-energy malnutrition (PEM) occurs in 65-90% of patients with liver cirrhosis. Severity~     of malnutrition correlates with progression of liver disease and leads to sarcopenia in~     30-70% of cirrhotic patients. Malnutrition and sarcopenia are associated with an increased~     risk of complications and mortality.~      In cirrhosis the gut microbiome is altered leading to increased gut permeability, bacterial~     translocation and inflammation. Since the microbiome is involved in nutrient uptake and~     metabolism, it is hypothesized that microbiome alterations contribute to sarcopenia. A~     prospective controlled cohort study to investigate the interrelation of microbiome changes~     and sarcopenia in cirrhosis will be conducted. Furthermore the effect of nutritional~     interventions on the microbiome in cirrhosis will be studied. From this study information on~     how the gut microbiome composition and sarcopenia are associated in cirrhosis and if~     modulation of the gut microbiome by nutritional interventions is feasible will be collected.~   "
37207|NCT03079609|"~     This study is to answer the question is there any relationship between viral ( HSV 1 , HSV 2~     , HPV 6/11, CMV, HHV 6 , HHV 8, BKV) or bacterial (Porphyromonas gingivalis, Treponema~     denticola, Tannerella forsythia, Fusobacterium nucleatum) infection and occurrence of~     varicocele in men.~   "
37208|NCT03079596|"~     Enhanced Recovery After Surgery (ERAS) programs have been introduced with purposes of~     reducing the surgical stress response and obtaining optimal recovery after surgery.~   "
37168|NCT03080116|"~     RATIONALE: Neoadjuvant hormonal therapy using luteinizing hormone releasing hormone (LHRH)~     agonists and/or anti-androgens has already demonstrated to downstage primary prostate cancer~     in patients treated by radical prostatectomy without a survival benefit. There is no evidence~     yet of a survival impact of LHRH antagonist (LHRHa) +/- new-generation anti-androgens in this~     setting. Thus novel studies are needed to assess this treatment combination.~      PURPOSE: To assess the difference in treatment antitumor effect between arms by measuring~     pathological tumor volume with minimal residual disease (MRD) following radical prostatectomy~     + pelvic lymph-node dissection (RP + PLND) for intermediate or high-risk prostate cancer~     patients.~   "
37169|NCT03080103|"~     On September the 15th, 2015, Italian surgeons, radiologists and pathologists with a special~     interest and expertise in the diagnosis and management of Acute Appendicitis (AA), met up~     under the auspices of the Italian Society of Hospital Surgeons (ACOI) in Oristano (Italy) to~     constitute the ACTUAA collaborative working group. The main objectives of the working group~     are:~      To create a working basis for analyzing the diagnostic features, treatment modalities and~     outcomes of interest of both the antibiotic-first approach and appendectomy for patients with~     uncomplicated AA.~      To investigate the clinical, laboratory and radiologic modalities adopted for the diagnosis~     To determine the outcomes of patients treated with antibiotics or appendectomy in the short~     and long term periods.~      To compare results according to the type of intervention. To stratify the risk of recurrence~     for patients treated with antibiotics according to clinical, laboratory and radiology~     findings.~      To evaluate the sensibility and specificity of clinical and laboratory scores for the~     diagnosis of uncomplicated AA.~      To identify a subgroup of patients with uncomplicated AA for whom antibiotic treatment can be~     highly effective.~      General study design The study protocol is designed according to the SPIRIT 2013 explanation~     and elaboration: guidance for protocols of clinical trials.~      The study period is estimated to be of 12 month + 12 month of follow-up (with a second~     session of follow-up following 5-years), beginning on 01/04/2017.~      Participants All adult patients (aged over 18 years old) with suspected AA will be admitted~     to the Surgical Department of the nine participating Italian hospitals, where they will be~     studied carefully by the on call surgeon.~      Patients will be then informed of the study protocol and invited to give written consent for~     participation and for sensible data collection for scientific purposes.~      Subsequently, only patients who will undergo diagnostic imaging (as specified later) and from~     whom a written informed consent will be obtained, can be enrolled in the study and registered~     by each Center using a uniform electronic registration form and database.~      General characteristics, medical history, clinical findings, physical investigation, and~     blood tests will be reported in the medical record. Pain will be quantified by Visual~     Analogue Scale (VAS) scoring system before administrating any pain medications and after the~     treatments.~      In order to enter the study, patients will have to undergo diagnostic imaging (US and/or CT~     scan or MRI scan) and only the diagnosis of uncomplicated AA confirmed by diagnostic imaging~     will permit patient enrollment in the study.~      Specific aims of the ACTUAA Study The objective of this prospective non-randomized~     controlled, multicenter, multidisciplinary trial is to compare the antibiotic therapy and~     emergency appendectomy for the treatment of patients with uncomplicated AA(without abscess or~     free perforation), confirmed by US and/or CT or MRI scan. No changes in the daily practice~     regarding the diagnostic, clinical and treatment pathways will be required to the~     participating centers. However, only the patients with uncomplicated AA, confirmed by one of~     the above mentioned radiologic tools will be enrolled in the study. The decision on which of~     the tools are to be adopted will be up to the local lead surgeon.~      Primary Outcome Measure:~      Number of participants with complication-free treatment success, defined as success of the~     initial treatment with uncomplicated course.~      Secondary Outcome Measures:~      Length of hospital stay; Pain evaluation; Time to return to normal activity; Period of~     sick-leave; Complicated appendicitis with peritonitis identified at the time of surgical~     operation; Quality of life as assessed by the Short Form 12-scale (SF-12)~   "
37170|NCT03080090|"~     Cigarette smoking is the leading cause of death and disability in the United States. Although~     smoking has declined since 1964, it is still very common among some groups of people. One~     such group is persons with emotional symptoms and disorders. There has been little success in~     developing treatments for smoking cessation for smokers with affective disturbances.~      Recent work suggests that being sensitive to, and less tolerant of, stress is associated with~     many problems in daily life. People with high 'stress sensitivity' tend to use avoidant~     strategies to cope with their stress, like smoking. Also, people with high levels of stress~     sensitivity report stronger beliefs that smoking will reduce negative feelings. They also~     report having a harder time quitting and in fact, are less successful at doing so. This~     information suggests that stress sensitivity is important to target during smoking cessation~     treatment for smokers with affective vulnerabilities.~      This clinical trial will evaluate a treatment that integrates exercise to reduce stress~     sensitivity among high stress sensitive smokers. It builds directly from our recent work and~     we now seek to adapt it to a more a more accessible and sustainable application. Results will~     provide important information on the benefit of an integrated intervention that could be used~     in the community for smokers at great risk for relapse and who do not benefit from existing~     alternative treatments. This study is the first to test an intervention for stress sensitive~     smokers and has the potential to help at-risk individuals experience quitting success and,~     ultimately, reduce the burden of tobacco-related cancers in Texas.~   "
37171|NCT03080077|"~     This prospective, randomized study is being conducted to evaluate the safety and~     effectiveness of corneal cross-linking (CXL) in patients with keratoconus or post-refractive~     ectasia (post-LASIK or PRK) utilizing two techniques: the standard Epi-Off technique or an~     Epi-On technique that utilizes iontophoresis (I-CXL) to deliver the riboflavin to the cornea~     without need for removal of the corneal epithelium. Patients will be randomized to receive~     CXL treatment with either the Epi-On or Epi-Off technique.~   "
37172|NCT03080064|"~     In this mixed methods study, the investigators assessed the feasibility and acceptability of~     a remote health coach intervention to promote healthful lifestyle behaviors among overweight~     pregnant women. At one northeastern US clinic, the investigators enrolled 30 overweight~     (pre-pregnancy BMI≥25 kg/m2) pregnant women at a median gestation of 12.5 weeks (IQR: 11-15)~     into a one arm intervention trial. The investigators connected participants with a health~     coach to provide behavioral support to help participants adopt or maintain healthy lifestyle~     goals during pregnancy. Health coaches contacted participants by phone every 2-3 weeks to~     monitor goals, and sent emails and text messages to check-in between calls. To assess the~     intervention, participants completed baseline (N=30) and follow-up surveys at the end of the~     intervention (N=26), as well as follow-up phone interviews (N=18).~   "
37173|NCT03080051|"~     The overall goal of this imaging trial is to evaluate [18F]MNI-952 (also known as~     [18F]UCB-K), a tau targeted PET radioligand.~   "
37174|NCT03080038|"~     The purpose of the SQUEEZE Trial is to determine which fluid resuscitation strategy results~     in the best outcomes for children treated for suspected or confirmed septic shock. In this~     study, eligible children will be randomized to either the 'Usual Care Arm' or the 'Fluid~     Sparing Arm'. Children will receive treatment according to current ACCM Septic Shock~     Resuscitation Guidelines, with the assigned resuscitation strategy used to guide~     administration of further fluid boluses as well as the timing of initiation and escalation of~     vasoactive medications to achieve ACCM recommended hemodynamic targets.~   "
37175|NCT03080025|"~     The purpose of this study is to determine how a CBCT® (Cognitively Based Compassion-Training)~     for couples affect aspects of health and especially social interactions in depressed female~     patients and their romantic partners. compare healthy and depressed couples during an~     instructed positive real-time social interaction in the laboratory.~      Furthermore the investigators aim to examine how social behavior and psychobiological~     indicators of health during real-time social interaction in the laboratory might be improved~     through CBCT® for couples.~   "
37176|NCT03080012|"~     In tuberculosis patients, salivary concentrations will be compared to plasma/serum~     concentrations of several anti-tuberculosis drugs. If salivary concentrations correctly~     represent blood concentrations, this non-invasive sampling of saliva could be used for TDM of~     the tested drugs.~   "
37177|NCT03079999|"~     This is a phase II prospective, randomized, double-blind, longitudinal study evaluating~     whether the administration of aspirin can delay or slow tumor growth and maintain or improve~     hearing in VS patients.~   "
37178|NCT03079986|"~     Currently it is unclear whether postoperative chyle leak (CL) after pancreatic surgery~     requires treatment. Thus, the present study aims to compare dietary treatment of CL with~     drain removal despite of persistent CL.~   "
37179|NCT03079973|"~     The objective of this phase III study is to evaluate the efficacy, systemic safety and local~     tolerability of P-3073 (calcipotriene 0.005%) nail solution in patients with mild to moderate~     psoriatic fingernail/s.~   "
37209|NCT03079583|"~     To assess the efficacy of the zinc biofortified rice on plasma zinc concentrations in infants~     from a rural area of Bangladesh.~   "
37210|NCT03079570|"~     The objective of this study is to determine which luminance levels yield maximum differences~     in critical flicker fusion (CFF) scores between younger and older normal subjects.~   "
37211|NCT03079557|"~     This is a pilot testing the feasibility of the 'REpurposing BOtulinum Toxin in Treatment of~     Obesity in Adolescents' trial (ReBOO-trial). The full-scale ReBOO will further investigate~     safety and efficacy of intragastric injections of botulinum toxin A into the antrum area of~     the stomach. These injections will be repeated every six months.~      The study sample will be adolescents with obesity who have not responded to standard~     conservative treatment.~   "
37180|NCT03079960|"~     Deep brain stimulation (DBS) of the subthalamic nucleus (STN) has developed into a standard~     therapy in the refractory stage of Parkinson's disease (PD). Implanted micro- and~     macroelectrodes can be used to derive neural signals from the basal ganglia (BG). Cortical~     signals can be obtained by measurements of the electroencephalogram (EEG) or the~     electrocorticogram (ECoG). Both signal types can be used to characterize the motor system of~     the patient and make it possible to estimate the effectiveness of a currently performed DBS.~     However, the relationship between such neuronal features on the one hand and the DBS~     stimulation parameters or the observable clinical effects on the other hand is very~     individual and varies from patient to patient.~      The aim of the present study is to: (1) determine neuronal characteristics that are~     informative about the clinically relevant motor status of PD patients. (2) The investigation~     and description of the complex non-stationary dynamics of neuronal characteristics as a~     consequence of changing DBS stimulation parameters. (3) The study of the effect of changing~     DBS stimulation parameters on motor performance.~      The three objectives form an important building block for future adaptive closed-loop DBS~     strategies (aDBS). Here, the stimulation parameters are to be adapted in the single-trial and~     depending on the currently detected motor state of the patient. Since this is accessible only~     to a very limited extent, it is to be investigated whether information about the motor state~     can be obtained from the neural features.~   "
37181|NCT03079947|"~     The purpose of this study is to evaluate the effectiveness of circulating DNA from peripheral~     blood for predicting the prognosis and relapse in DLBCL and PTCL patients.~   "
37182|NCT03079934|"~     Evaluation of coronary artery vessel wall healing at different time points in patients~     undergoing implantion of bioresorbable vascular scaffold by using intravascular imaging~   "
37183|NCT03079921|"~     To determine the effect of sympathetic neural and hormonal (epinephrine) input on islet cell~     hormonal responses to insulin-induced hypoglycemia in type 1 diabetic recipients of~     intrahepatic islet transplantation. We hypothesize that α-adrenergic (neural) blockage will~     abolish insulin-mediated suppression of C-peptide, attenuating α-cell glucagon secretion~     during hypoglycemia, and that β-adrenergic (hormonal) blockage will have no effect. Glucose~     counterregulatory responses will be measured during hyperinsulinemic euglycemic-hypoglycemic~     clamps on three occasions with randomized, double-blind administration of the α-adrenergic~     blocker phentolamine, the β-adrenergic blocker propranolol, or placebo. The demonstration of~     neural rather than hormonal regulation of the transplanted islet cell response to~     hypoglycemia is critical for understanding the mechanism for protection from hypoglycemia~     afforded by intrahepatically transplanted.~   "
37184|NCT03079908|"~     Virtual reality surgical simulators (VRSS) are gaining popularity for general surgery~     training, both for conventional laparoscopic and robotically-assisted surgery. Although~     numerous studies have analysed the impact of VRSS training on surgical skills, there is a~     lack of data regarding the comparison of robotic VRSS (RVRSS) and laparoscopic VRSS (LVRSS)~     training on conventional laparoscopic skills among subjects with no prior surgical~     experience. The hypothesis of the present study is that RVRSS could improve conventional~     laparoscopic skills as much as laparoscopic LVRSS among naïve subjects~   "
37185|NCT03079895|"~     This project will study the effectiveness of computerized cognitive behavioral therapy (CBT)~     in reducing depression symptoms. The design is a two-arm randomized controlled trial~     comparing (i) control arm, which is treatment as usual with (ii) treatment arm, which is~     treatment as usual plus computerized CBT. The primary outcome measure is change in depression~     symptom severity. The name of the computerized CBT program to be used in the study is Thrive.~   "
37186|NCT03079882|"~     Ten percent of American adults, more than 20 million people, have chronic kidney disease,~     which in the advanced state of end stage renal disease is most desirably and cost-effectively~     treated by kidney transplantation. However, 20-30% of transplanted kidneys fail in living~     recipients by 10 years, owing largely to insufficient monitoring methods. The goal of the~     proposed research is to improve noninvasive kidney transplant monitoring using a new~     ultrasound-based imaging method called Viscoelastic Response (VisR) ultrasound.~   "
37187|NCT03079869|"~     Transition to Ferric Citrate among Hemodialysis and Peritoneal Dialysis Patients: A Phase 4~     Real World Experience Study from Kaiser Permanente Southern California~   "
37188|NCT03079856|"~     This project will develop a technology-augmented HIV and substance use risk reduction~     intervention for delivery in the Emergency Department, a medical setting where at-risk~     emerging adults who use drugs and engage in HIV-related risk behaviors are likely to present.~   "
37189|NCT03079843|"~     Healthy volunteers will be exposed to ambient air near a roadway under the conditions of with~     and without a facemask and their responses will be evaluated.~   "
37190|NCT03079830|"~     The study evaluates the efficacy of local anesthestic application through the catheter in the~     surgical wound for the postoperative pain relief after minimally invasive aortic valve~     surgery. The patients will be enrolled in two different groups according to the protocol of~     the local anesthetic and saline administration:~        1. group: continous infusion of the local anesthetic plus bolus on demand~        2. group: continous infusion of saline plus bolus on demand For all patients metamizol~          every 12 hours plus bolous of piritramid on demand.~   "
37191|NCT03079817|"~     In past work is has been shown that yoga can be as effective as a standard balance or Tai Chi~     protocol; however, there is an inability to distinguish between the mind and body~     contributions of yoga training. This study will compare an accepted proprioceptive training~     program to a meditation program which concentrates on body awareness in individuals with~     Parkinson's disease.~   "
37192|NCT03079804|"~     The ankle joint is often affected by injuries, especially lateral sprains, often leading to~     chronic instability. Joint mobilization techniques seem to influence the sense of joint~     positioning. The objective of the study is to compare mobilization techniques in the balance~     of athletes with chronic ankle instability. A randomized clinical trial with participants~     allocated in three groups: Talocrural manipulation, mobilization with movement and placebo~     will be assessed in their primary endpoints and secondary balance and dorsiflexion range of~     motion respectively.~   "
37193|NCT03079791|"~     The aim of this study is to use the high resolution of optical coherence tomography to assess~     the prevalence of different types of cardiac allograft vasculopathy (CAV) in cardiac~     transplanted patients and correlate those results with the level of immunosuppression~   "
37194|NCT03079778|"~     Hypothesis: Patients with hepatocellular carcinoma (HCC) have few options if they fail or are~     unable to undertake surgery, transarterial chemoembolization (TACE) and/or chemotherapy.~     Radiation (RT) in a range of doses has been combined with TACE in several case cohort studies~     demonstrating safety and a dramatic improvement in survival. Clearly these trials are subject~     to bias due to non-randomized selection, possible lack of generalizability to Canadian~     patients, and heterogeneous patient populations.~      Objective: Therefore, there is a high priority need to investigate the addition of RT to TACE~     in a randomized fashion to determine if we can improve survival in this rapidly growing poor~     prognosis patient population that have no other options.~      Methodology: TACE eligible patients with HCC will be randomized to TACE alone or TACE plus~     radiation (TACERT). They cannot be eligible for standard treatments such as transplant and~     resection. Primary endpoint will be time-to-intrahepatic-progression. Secondary endpoints~     will be response rate (Modified RECIST criteria), overall survival, local failure,~     extrahepatic failure, toxicity, quality of life and economic feasibility.~   "
37195|NCT03079765|"~     This study evaluates the effects of delivering training services via telehealth to educators~     in rural schools. The investigators hope to increase the accuracy with which educators~     implement functional behavior assessments in schools. During the study, participants will~     receive training on functional behavior assessments at different periods. When one school is~     receiving training, other schools will not be receiving training. The purpose will be to show~     increased accuracy of functional behavior assessments only occur following training.~   "
37196|NCT03079752|"~     The Nurse-Family Partnership, a program of prenatal and infancy home visiting by nurses, has~     been examined in a series of 3 randomized trials since 1977. It has received considerable~     attention in the scientific and public policy communities for its replicated effects on a~     variety of maternal and child health outcomes across these 3 trials, including prenatal~     health, childhood injuries, rates of subsequent pregnancies, inter-birth intervals, as well~     as its long-term effects on maternal life-course, criminal behavior, and 15-year-olds'~     criminal and antisocial behavior in the first trial of the program conducted in Elmira, New~     York.~   "
37197|NCT03079739|"~     Treatment of ischemic myocardium with percutaneous coronary intervention (PCI) in addition to~     optimal medical therapy reduces major adverse cardiac events. However, less than half of~     patients have a noninvasive ischemic evaluation before revascularization. Fractional flow~     reserve (FFR) can determine the hemodynamic significance of a coronary lesion by measuring~     the distal mean coronary and aortic pressures during maximal hyperemia. Previous studies~     conducted principally in stable coronary artery disease (CAD) patients have demonstrated that~     FFR-guided revascularization improves clinical outcomes, quality of life, and~     cost-efficiency. However, the reliability and safety of FFR assessment in different setting~     than stable CAD is unclear. In addition, the majority of studies are performed with the only~     one device. No data are available from other clinically used devices. The HALE BOPP registry~     is an investigator-initiated observational study, designed to prospectively include all~     patients referred for coronary angiography in which at least 1 lesion was evaluated by FFR.~   "
37198|NCT03079726|"~     This is an investigation to examine the correlation and predictive ability of activity~     measures obtained from cardiovascular implantable electrical devices.~   "
37199|NCT03079713|"~     Intravitreal injections are an efficient method of delivering therapeutic levels of~     medications to the posterior segment of the eye. Prior to receiving an injection, there are~     various methods to provide ocular anesthesia. Vibration may have an anti-nociceptive effect~     by directly decreasing the sensitivity of peripheral nociceptors or by reducing signal~     transmission from peripheral nociceptors to the brain with activation of vibratory sensation~     pathways. The purpose of this study is to evaluate the use of a handheld fingertip vibrator~     compared to topical eye drops for pain control while performing intravitreal eye injections.~     A secondary objective of the study is to measure corneal and conjunctiva sensitivity with and~     without activation of the vibrator to the lower lid using a Luneau Cochet-Bonnet~     aesthesiometer.~   "
37200|NCT03079700|"~     Mucosal immunology during helminth infection~   "
37201|NCT03079687|"~     This is an open-label, single-arm, international, multicenter Multiple Patient Expanded~     Access Program (MPEAP). The program is designed to provide treatment access to olaparib~     tablets for patients with platinum-sensitive relapsed high-grade epithelial ovarian,~     fallopian tube or primary peritoneal cancer without other treatment options or eligible for~     an olaparib clinical trials.~   "
37202|NCT03079674|"~     The burden of non-disabling ischemic cerebrovascular events (NICE) is significantly~     increased. In order to achieve accurate risk stratification and effective treatments,~     developing new diagnostic, therapeutic, and prognostic strategies is indispensable. Chinese~     registry of NICE is a national multi-center prospective study aimed to explore the~     epidemiology, new biomarkers, risk factors and prognostic models.~   "
37203|NCT03079661|"~     All COPD patients with a diagnosis of acute exacerbation in emergency room in University~     Hospital of Amiens-Picardie between 01/01/2017 and 31/12/2017. The investigator will collect~     for each patient the home address and the work address. The duration of 1 year was chosen to~     take into account seasonal variations. In parallel, a daily report of the rate of ozone,~     particles (PM2.5 and PM10), dioxide nitrogen but also odours and pollens will be done by ATMO~     Picardie.~   "
37204|NCT03079648|"~     This study was conducted to investigate the effects of daily supplementation of Angelica~     gigas N. extract on improvement of Blood Triglyceride.~   "
37205|NCT03079635|"~     The purpose of this research is to determine if body composition influence the effect of~     breakfast composition on postprandial (post-meal) hunger, metabolic and energy expenditure~     response in normal weight, overweight, and obese young women.~   "
37206|NCT03079622|"~     The study titled, Manual Versus Electric Vacuum Aspiration for Pregnancy Termination Between~     10-14 weeks: A Randomized Trial, is a randomized trial to compare procedure times for manual~     and electric vacuum aspiration for surgical abortion between 10 0/7 and 13 6/7 weeks~     gestation. Women presenting for surgical abortion between 10 0/7 and 13 6/7 weeks gestation~     will be randomized to either undergo manual vacuum aspiration (MVA) or electric vacuum~     aspiration (EVA). The investigators hypothesize that operative times will be increased when~     using manual vacuum aspiration, as compared to electric vacuum aspiration, for surgical~     abortion performed in the late first trimester (10 0/7 and-13 6/7 weeks).~   "
37215|NCT03079505|"~     DANIN study is a randomized, phase 3 clinical trial comparing 'head to head' Nilotinib versus~     Dasatinib as upfront therapy for patient with chronic myeloid leukemia. The efficacy of both~     drugs will be tested by measuring BCR/ABL (BCR-ABL = fusion gene from BCR (breakpoint cluster~     region gene/BCR gene product) and ABL (Abelson proto-oncogene)) using European Leukemia net~     recommendations the study will be conducted in NCCCR (National Center for Cancer Care &~     Research) sample size calculations detailed in the statistic part the clinical hematologist~     will recruit the patients this will include consenting process inclusion and exclusion~     criteria the molecular pathologist will do the molecular testing the clinical research~     coordinator and fellows will do the CRF (Case Report Form) as well as quality of life~     questionnaire and applying the protocol for evaluation of cardiac evaluation Molecular~     monitoring of BCR-ABL1 transcripts to assess treatment response in CML (Chronic Myeloid~     Leukemia).~   "
37216|NCT03079492|"~     Moderate hypothermia has been demonstrated to be the effective treatment for neonates with~     hypoxic-ischemic encephalopathy (HIE). However, few studies reveal the actual alterations in~     physiological parameters (i.e. brain temperature and cerebral blood flow) of neonates~     undergoing cooling, especially for HIE lesions. Therefore, this project aims to utilize the~     magnetic resonance imaging (MRI), i.e. MR thermal imaging and phase contrast MRI to measure~     the changes of these parameters before and during hypothermia; and then make comparisons with~     the routine nasopharyngeal and rectal temperature. All these would provide in vivo~     quantitative data for therapeutic evaluation and promote the optimization.~   "
37217|NCT03079479|"~     Introduction: Total hip arthroplasty has been increasingly used as a means of treating the~     various pathologies of this joint. However, this surgical reconstruction initially brings~     important deficits in subjects submitted, such as: inhibition of muscle strength, limitation~     of range of motion and functional deficit. Therefore, an immediate physiotherapeutic~     treatment is necessary in the short and long term, taking into account both biomechanical~     issues and the quality of life of these individuals.~      Objective: To evaluate the clinical evolution of individuals submitted to total hip~     arthroplasty in the ten year period.~      Method: Twenty individuals submitted to unilateral total hip arthroplasty will be evaluated~     by the medical group of hip surgeries of the Brotherhood of Santa Casa de Misericórdia of São~     Paulo, during a period of ten years. These individuals will undergo a primary clinical~     evaluation and after signing the consent form, will be evaluated functionally with the HARRIS~     HIP SCORE and WHOQOL-bref questionnaires and physically with the analysis of muscular~     strength through manual dynamometry to measure the strength level of the Muscles involved in~     the bilateral coxo-femoral joint, such as abductors, adductors, flexors, extensors, internal~     rotators, external rotators, knee joint, such as extensors and flexors, and ankle, plantar~     flexors. Finally, they will be referred to the kinematic gait analysis, to identify the~     functional characteristics of these individuals, through reflexive markers at specific~     anatomical points, where they will walk for 5 minutes on a treadmill at a speed of 1.5km per~     hour.~   "
37218|NCT03079466|"~     Objective: To analyze the impact of CPAP treatment on cognitive, clinical and quality of life~     domains in patients over 70 years of age with mild-to-moderate OSA~      Primary Outcome: Epworth scale and QSQ domains~      Secondary Outcomes: Neurocognitive variables and CPAP adherence~   "
37219|NCT03079453|"~     A prospective randomized clinical trial that included thirty subjects who underwent~     tonsillectomy. The patients in Group 1 (n:15) were injected with dexamethasone (1 ml, 8 mg)~     through the uvula and soft palate tissue directly before tonsillectomy. Group 2 (n:15)~     patients had tonsillectomy without dexamethasone injection. Patients were examined~     preoperatively and postoperative on the first and fifth days. In this study investigators~     tried an approach of dexamethasone application to reduce uvula edema after tonsillectomy.~   "
37220|NCT03079440|"~     GI tract including pancreas is the one of most common primary sites of neuroendocrine tumors.~     Current grading of neuroendocrine tumors are based on the 2010 WHO classification. This~     classifies grade 3 tumors as the neuroendocrine tumor with mitosis > 20 per 10 high power~     field or Ki-67 labeling index > 20%. Etoposide-based chemotherapy, mostly as the combination~     with cisplatin, has been the mainstay of the treatment for patients with grade 3~     neuroendocrine tumors. However, a recent large retrospective analysis has suggested this~     regimen may not be effective in relatively low Ki-67 labeling index. Therefore, the~     investigators designed a clinical trial testing temozolomide-capecitabine combination, which~     has been mostly investigated in well differentiated (ie., grade 1 or 2) neuroendocrine~     tumors, in patients with grade 3 and low Ki-67 gastroenteropancreatic neuroendocrine tumors.~   "
37221|NCT03079427|"~     There is no proven adjuvant treatment after curative surgical resection in patients with~     cholangiocarcinoma, although previous meta-analysis suggested potential survival benefit of~     adjuvant chemotherapy or radiotherapy in patients with lymph node-positive resected~     cholangiocarcinoma. Despite of lack of level 1 evidence and no data which regimen is optimal,~     adjuvant chemotherapy is widely used in daily practice setting. Based on this background, the~     investigators designed the randomized phase 2 trial comparing capecitabine and gemcitabine~     plus cisplatin in patients with resected lymph node-positive extrahepatic cholangiocarcinoma.~   "
37222|NCT03079414|"~     Sudden cardiac death (SCD) remains a major cause of mortality within developed nations~     despite aggressive efforts to reduce its societal burden. Despite extensive clinical and~     genetic investigations, a subgroup of cardiac arrests remain unexplained, highlighting the~     potential contribution of additional cardiac conditions that may not be identified with~     contemporary diagnostic algorithms. The EPS ARREST study aims to evaluate the role of~     invasive electrophysiology study within this patient population.~   "
37248|NCT03079076|"~     Ultrasound guided thoracolumbar interfascial plane (TLIP) block was first described in 2015~     by Hand et al. TLIP block involves injection of local anesthetics between multifidus and~     longissimus muscles at the third lumbar vertebra level and can block the dorsal rami of~     thoracolumbar nerves. In new approach differently, the investigators made the injection~     between longissimus and iliocostalis muscles with a 15 degree angle from medial to lateral.~      The aim of this study is to determine effectiveness of ultrasound guided thoracolumbar~     interfascial plane (TLIP) block in patients undergoing spinal surgery.~   "
37304|NCT03078348|"~     The purpose of this research study is to compare a new educational material to another widely~     available educational brochure. The goal is to see if the new educational material will~     change knowledge and behaviors about colorectal cancer and colorectal screening.~   "
37223|NCT03079401|"~     Patients under the age of 5, with a diagnosis of hypoplastic left heart syndrome (HLHS),~     unbalanced atrioventricular canal (uAVC), or borderline left heart who are undergoing staged~     LV recruitment following bidirectional Glenn (BDG) or undergoing BDG with plans for LV~     recruitment will be considered for enrollment in this study. Those patients enrolled in the~     study will be randomized to either the experimental arm or control arm of the study. Those~     patients randomized to the experimental arm will receive mesenchymal precursor cells (MPCs)~     injected directly into the LV endocardium during their LV recruitment or BDG procedure. Those~     patients randomized to the control arm will receive normal standard of care during their~     procedure with no injection of MPCs.~      It is believed that injection of MPCs will help improve the chances of those patients with~     single ventricle or borderline left ventricle being converted to biventricular circulation~     which could improve quality of life and longevity over palliation.~   "
37224|NCT03079388|"~     Acute malnutrition in pregnancy is a risk factor for adverse outcomes in mothers and their~     unborn children. Undernutrition during pregnancy can result in maternal complications such as~     life-threatening hemorrhage and hypertensive disorders of pregnancy and infant complications~     such as intrauterine growth retardation, low birth weight, pre-term delivery and poor~     cognitive development. Poor women in the developing world are at heightened risk of~     malnutrition due to inadequate dietary intake and are subject to transmission of a number of~     infections including malaria, intestinal helminths, and genitourinary infections. Food~     interventions for malnutrition may be less effective under conditions with excessive~     inflammation and infection, and especially so during pregnancy. Without specifically~     addressing treatment for infections, undernourished mothers may be less responsive to~     nutritional interventions. The benefits of treating both malnutrition and common infections~     simultaneously remain largely unstudied. This study tests the hypothesis that malnourished~     pregnant women receiving 100 grams per day of a specially formulated ready-to-use~     supplementary food in addition to a combination of 5 anti-infective interventions will have~     greater weight gain in pregnancy and deliver larger, longer infants than women receiving the~     standard of care. The outcome of the pregnancy and maternal nutritional status will be~     followed until 6 months after delivery.~   "
37225|NCT03079375|"~     Background~      It is well known that the transfer of a patient from hospital to the general practitioner is~     related with mistakes in the medication of the patient. A report from 2006 measure the number~     of drug related admissions in Denmark to be 69.000 to 162.000 per year. To reduce these~     mistakes, more and better communication between the health professionals are suggested.~     Furthermore medication reviews made by pharmacist seems to reduce the number of drug related~     readmissions and other drug related issues, which can lead to an economic cost reduction.~      Objective~      The aim of this study is to investigate the impact of medication review and better~     communication between the health professionals after discharge of a patient from hospital to~     the general practitioner. The effect is measured as reducing the number of readmissions and~     number of visits at the emergency department 30 days and 6 month after inclusion of the~     patient.~      Method~      This study was estimated to include 1500 participants. The patients were randomized to one of~     three groups; usual care, basic intervention or extended intervention. The usual care~     received the normal care following the Danish standard procedure. The basic intervention had~     a medication review by a clinical pharmacist during admission.~      The extended interventions group was similar to the basic intervention group plus follow-up~     with the patient, the general practitioner and if relevant the nursing home and pharmacy 1~     week and 6 month after discharge by interview with the clinical pharmacist.~   "
37226|NCT03079362|"~     The study evaluates the anatomical distribution of the assessed Electromyogram (EMG)~     responses ensuring after sensory nerve root stimulation and obtained IOM grading during~     selective dorsal rhizotomy (SDR) with regard to level and, side of the body and gender as~     well as pain management and outcome data.~   "
37227|NCT03079349|"~     To test whether the investigator's educational methodology is associated with increasing~     learning of participants. The investigators second objective is to test the hypothesis that~     learning in an online classroom would result in similar outcomes as the traditional~     classroom.~   "
37228|NCT03079336|"~     Pragmatic randomized controlled trial (expected N = 80) of cognitive-behavioral therapy (CBT)~     to contrast two psychotherapeutic implementation strategies (State-of-the-Art welcome phase~     vs. prolonged focus on sudden changes). Blinded allocation of implementation strategy for~     patients; open label for therapists (no blinding possible), randomized allocation for~     patients, therapist allocation via ABAB-design (crossed-therapist design). Post treatment~     self-reported outcome will be measured based on a latent outcome factor (i. e. outcome~     composite).~   "
37229|NCT03079323|"~     Prospective non-randomized phase 2 trial to study the efficacy of additional elective~     para-aortic RT (PART) in pN1 patients compared to those who were historically treated with~     adjuvant whole pelvic radiotherapy (WPRT) alone.~   "
37230|NCT03079310|"~     Balance and gait impairment increases the risk of falls and contributes to a reduced quality~     of life and shorter survival in Parkinson disease (PD) patients. In preliminary case studies,~     electrical epidural spinal cord stimulation (SCS) has been shown to significantly improve~     gait, postural instability, rigidity, and tremor. Controlled studies for optimizing which~     stimulation settings produce the best clinical response for mobility and gait, and achieving~     these results chronically are all significant unmet needs. Using quantitative laboratory and~     mobile technologies to test a range of stimulation settings, this research study aims to~     determine which SCS parameters or combination of parameters is best suited to effectively~     alleviate disabling symptoms experienced by each PD patient.~   "
37231|NCT03079297|"~     This randomized double-blind placebo-controlled crossover study seeks to evaluate the~     antidepressant effect of L-leucine, an essential amino acid, in patients with Major~     Depressive Disorder (MDD).~   "
37232|NCT03079284|"~     Ten infants undergoing therapeutic hypothermia for hypoxic-ischemic encephalopathy will be~     enrolled in a new protocol that will allow mothers to hold their infants during the~     hypothermia treatment period. This is a safety study that will assess whether or not there is~     an increase in adverse event frequency in infants that are held during hypothermia. Parents~     and NICU nurses will be given a questionnaire after holding is complete investigating their~     feelings on maternal-infant bonding and safety of the holding protocol.~   "
37240|NCT03079180|"~     Tendons are essential structures for transmitting muscle forces to skeletal structures. A~     stiffer tendon will transmit muscle force faster, and then allow faster movement. Moreover,~     tendons are a living tissue and respond to mechanical forces by changing their metabolism as~     well as their structural and mechanical properties. The aim of the present study is to answer~     essential questions remaining unanswered that are necessary in order to optimize physical~     activity with ageing in humans, and thus improve quality of life in elderly. The main~     questions are: What is the minimal training intensity leading to tendon adaptations? What is~     the time-course of tendon adaptations? Does the same loading protocol lead to similar tendon~     adaptations for different tendons (Achilles vs Patellar) and does the same training program~     lead to identical tendon adaptations with age (25yrs vs 75yrs)? To answer these questions,~     tendon architecture and mechanical properties will be investigated in humans of different age~     and applying different training intensities. The kinematic of the tendon adaptations due to~     these different training characteristics will also be investigated. The training protocol~     will be applied on plantar flexors and knee extensors. MRI and ultrasound techniques as well~     as the use of ankle and knee ergometers will allow the quantification of possible~     modifications in tendon architecture and mechanical properties (tendon stiffness and Young's~     Modulus). This will be assessed in vivo, using ultrasound images to assess tendon~     displacement during an incremental maximal contraction.~   "
37241|NCT03079167|"~     Double-blind, placebo controlled Phase III trial of erythropoietin for hypoxic ischaemic~     encephalopathy in infants receiving hypothermia. The study aim is to determine whether Epo in~     conjunction with hypothermia in infants with moderate/severe hypoxic ischaemic encephalopathy~     (HIE) will improve neurodevelopmental outcomes at 2 years of age, without significant adverse~     effects, when compared to hypothermia alone.~   "
37242|NCT03079154|"~     The study is a three-arm intervention, where students are randomly assigned to one of three~     conditions: Teacher-led group-based MBCT, Self-guided MBCT using an audio book, or 'wait~     list' control. Pre-intervention, respondents complete a questionnaire assessing self, values,~     psychological processes related to self, and well-being. Post-intervention, respondents~     complete the same questionnaire, and then take part in a laboratory-based study which~     assesses behaviours related to the variables measured in the questionnaires. We are aiming~     for a sample size of 180 students at Sussex, 60 in each intervention arm.~   "
37243|NCT03079141|"~     Chronic central serous chorioretinopathy (cCSC) is a relatively frequently occurring eye~     disease that is often diagnosed in patients in the professionally active age range. In this~     disease, a subretinal fluid accumulation occurs, due to abnormalities in both the choroid and~     the retinal pigment epithelium. This specific form of macular degeneration can cause~     permanent vision loss, image distortion, and loss of color and contrast vision. An early~     diagnosis and treatment may improve the visual outcome and quality of life.~      To date there is no international consensus on the optimal treatment of cCSC. Many~     retrospective studies suggest that treatment with photodynamic therapy (PDT) is effective in~     chronic CSC. Treatment with oral eplerenone may also be effective in this disease.~      In this proposed prospective randomized controlled trial, cCSC patients will be randomized~     into one of both treatment groups: either half-dose PDT or oral eplerenone treatment. The~     trial is a superiority study, because retrospective studies suggest that PDT treatment may be~     more effective than eplerenone treatment.~      The null hypothesis of the study is that PDT treatment is more effective than eplerenone~     treatment in patients with active cCSC. The alternative hypothesis is that PDT treatment is~     not superior to eplerenone treatment.~      Treatment success will not only be based on characteristics on ophthalmological imaging, but~     also on functional endpoints (both on the outcome of questionnaires, best-corrected visual~     acuity, and microperimetry), which are most important from a patient's perspective.~      The study will take place in 3 large tertiary referral university hospitals in The~     Netherlands that have extensive experience with conducting clinical trials (Academic Medical~     Center (Amsterdam, the Netherlands), Radboud University Medical Center (Nijmegen, the~     Netherlands), and Leiden University Medical Center (Leiden, the Netherlands). Both the~     Radboud University Medical Center and the Leiden University Medical Center have been involved~     in the first prospective randomized controlled trial that is currently conducted in cCSC.~      This study will last 2 years per participant. Each participant will visit the outpatient~     clinic for a maximum number of 6 visits.~      A total number of 107 patients will be included in the trial. Depending on the speed of~     inclusion of patients in this trial, the total duration of this study can be determined.~   "
37244|NCT03079128|"~     There is a body of evidence that has evaluated the effect of Weight Watchers, a commercially~     available weight loss program, on changes in body weight. The current investigation aims to~     add to this body of evidence by providing additional data on changes in body weight and~     enhance the current evidence-base in regards to evaluating other health-related outcomes.~      There is little evidence that demonstrates whether or not the weight loss as a result of the~     Weight Watchers program elicits changes in health-related functional outcomes such as aerobic~     capacity, flexibility, sleep, and other psychological measures. Additionally, within a~     scientific research protocol, measures of adherence and satisfaction will also be evaluated~     evaluated. This study will evaluate these outcomes beyond weight changes achieved across the~     24-week program.~   "
37245|NCT03079115|"~     The purpose is to test whether a short-term, high-dose atorvastatin treatment (80mg once a~     daily (QD) from 3 days before to 3 days after CAS, then 20 mg QD until 30 days after CAS) is~     superior to conventional-dose atorvastatin treatment (20 mg QD from 3 days before to 30 days~     after CAS), in terms of efficacy for prevention of periprocedural ischemic brain damage in~     Chinese patients undergoing CAS.~   "
37246|NCT03079102|"~     Phase II double blind (participants and investigator) placebo controlled randomized (1:1)~     clinical trial of inhaled nitric oxide (iNO) 20 ppm administered over 12h beginning as soon~     as possible but within 4 h of return of spontaneous circulation (ROSC) from out-of-hospital~     cardiac arrest (OHCA). Planned enrollment is 130 subjects over 24 months at University of~     Pittsburgh Medical Center (UPMC) Presbyterian and UPMC Mercy with randomization stratified in~     blocks of 8. Recruitment will be performed under exception from informed consent (EFIC) to~     facilitate early enrollment and treatment. The study will have a pre-specified safety~     analysis at the mid-point (after 1 year or 60 patients whichever occurs first). Subjects will~     be screened by members of the University of Pittsburgh post-cardiac arrest service (PCAS),~     all of whom will serve as the study co-investigators, and the Research Coordinators.~     Notification of inclusion under EFIC will be performed as soon as possible by a member of the~     study team generally to a surrogate as the subjects will be comatose after OHCA.~   "
37247|NCT03079089|"~     Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is the only treatment option~     with a significant chance of healing in lymphoid hematological refractory or multiple~     relapses after chemotherapy. However, all patients with an indication of allo-HSC can not~     benefit because of two limitations: the toxicity of the treatment and graft shortage~     available.~      For patients refractory or in relapses with an indication of allo-HSC, used the combinaison~     of an SET followed by the reduced-intensity allo-HSC (RIC) has shown some interesting~     results.~      A post-transplant immune modulation with prophylactic injections of donor lymphocytes (PDLI)~     showed its effectiveness to decrease the risk of relapse while having a lower toxicity than~     chemotherapy~   "
37249|NCT03079063|"~     The purpose of this multicentre, randomized, double blinded, single dose, two-way cross-over~     study, is to compare the pharmacokinetics (PK) of biosimilar eptacog alfa (activated) with~     Novoseven in 24 patients, adult and children (>12 years), not bleeding, with inherited~     coagulation factor VII (FVII) deficiency (FVII <1%). Patients will be randomized to receive~     either a single dose of eptacog alfa biosimilar 30 μg/kg and one single dose of NovoSeven 30~     μg/kg, or vice versa, with doses separated by a washout period. All patients will be followed~     12 months and will receive biosimilar eptacog alfa, on demand, for every bleeding episode~     that should occur - or - for prophylaxis, with the aim of monitoring of inhibiting antibody~     formation, lack of efficacy and collection of safety data.~      Additional 26 patients with the same inclusions and exclusions criteria will be included in~     this study (for a total 50 patients). These patients will not enter the PK phase of the study~     but they will be followed to receive biosimilar eptacog alfa, on demand, for every bleeding~     episode that should occur during 12 months - or - for prophylaxis, with the aim of monitoring~     of inhibiting antibody formation, lack of efficacy and collection of safety data. The~     modality of treatment with biosimilar eptacog alfa (on demand or prophylaxis) will be decided~     by the Investigator.~   "
37250|NCT03079050|"~     Dexlansoprazole modified release (MR), the R-enantiomer of Lansoprazole, is an FDA approved~     drug (2009) for the management of erosive esophagitis and nonerosive reflux disease 1.~     Dexlansoprazole has a unique dual delayed-release delivery system designed to address unmet~     needs that may accompany traditional proton pump inhibitors, with two separate pH-depended~     release phases, the first in the proximal duodenum and the second in the more distal small~     intestine. This dual release system extends the plasma concentration and pharmacodynamics~     effects beyond those of single-release PPIs, allowing for dosing at any time of the day~     without regard to meals 1. A study conducted by Fass et al. has shown that the use of~     dexlansoprazole MR 30 mg in patients with symptomatic GERD is significantly more effective~     than placebo in improving nocturnal heartburn, reducing GERD-related sleep disturbances, and~     consequently improving work productivity, sleep quality and quality of life 2.~      Because of its pharmacokinetic properties, Dexlansoprazole modified release (MR) may prove~     beneficial in optimizing the management of GERD and the associated burdens that often surface~     after the heavy evening and Suhur meals, such as increased nocturnal symptoms and poor sleep~     quality.~   "
37251|NCT03079037|"~     This study will test the hypothesis that deep brain stimulation (DBS) targeting specific~     changes in oscillatory activity at the site of stimulation will prove superior to continuous~     isochronal DBS thus providing the rationale for development and optimization of closed loop~     paradigms and determine whether the optimal closed-loop biomarker varies across subcortical~     targets, is task dependent, or serves to re-establish a default network that removes an~     underlying disruptive physiological state leading to greater improvement in motor signs and~     task performance.~   "
37252|NCT03079024|"~     The purpose of this study is to determine whether cognitive training exercises can improve~     cognitive functioning in young patients with recent-onset schizophrenia, schizoaffective,~     schizophreniform, and psychosis NOS who are being treated in community mental health~     settings. The investigators will examine the effects of web-based cognitive training~     exercises delivered on a portable laptop computer. The findings will provide valuable~     information on whether cognitive training can improve the cognition and functioning of young~     individuals early in the course of schizophrenia.~   "
37253|NCT03079011|"~     This study is a randomized, open-label, multicentric, phase III trial conducted in patients~     receiving aromatase inhibitor and palbociclib as first line therapy for estrogen receptor~     (ER)-positive HER2-negative metastatic breast cancer and which aims to evaluate, at the onset~     of ESR1 mutations in circulating tumor DNA, the efficacy of a change of the hormone therapy~     (aromatase inhibitor changed to fulvestrant) combined to palbociclib, together with the~     safety of hormone therapy and palbociclib combination in the overall population.~   "
37254|NCT03078998|"~     Juvenile Idiopathic Arthritis (JIA), Cerebral Palsy (CP), and Obstetric Brachial Plexus~     Injury (OBPI) are the most common disorders that cause upper extremity impairments in~     children. Depending on the underlying pathologies, the common symptoms of these disorders are~     the limitations of the upper extremity joint movement angles, muscle imbalance and the~     functional limitations caused by the contracture due to these problems. Daily life activities~     such as feeding, personal care, and self mobility activities that use upper extremity are~     commonly limited with these children. Physical rehabilitation is mostly used to address these~     problems. However, the process of rehabilitation is difficult and lengthy. In addition, most~     of the time, classical rehabilitation is discouraging for many young patients. Employment of~     digital technology has been gaining momentum in addressing the above rehabilitation problems~     among the medical professionals.~      By utilizing exciting new sensor technologies, such as Microsoft Kinect, Nintendo Wii and~     Leap Motion, practical game based rehabilitation applications have been becoming popular.~     Video Based Games (VBG) that adopt the these technologies as Human Computer Interaction (HCI)~     interfaces are recently used successfully for the task of rehabilitation. The Leap Motion~     device, one of the new examples of these technologies, has a very small form factor. It~     includes two near infrared stereoscopic cameras to capture hand images of patients to produce~     3 Dimensional (3D) positions of hand joints at a very fast rate with a sufficient positional~     precision.~      There have been examples that use motion sensor based VBG's for the rehabilitation of~     different types of patient groups. Compared to classical rehabilitation practices, these~     applications provide many advantages such as ease of use, repeatableness, and instantaneous~     measurable feedback. In addition, the young patients involved in these applications~     demonstrated willingness to participate in these activities and they showed considerable~     progress in upper extremity rehabilitation. However, these VBG's were mostly developed for~     general public and it was often suggested to develop VBG's for the specific task of upper~     extremity rehabilitation of children. It is known that upper extremity specific VBG's and~     their applications are very limited both at the global and domestic levels.~      With this project, we plan to design and develop specialized Leap Motion based VBG's for the~     children diagnosed with JIA, CP, and OBPI. These VBG's will be designed to be easy to use and~     motivating for the children. They will automatically lead the patients to correct hand~     exercises and they will provide mechanisms for online performance measurements of the~     patients. The performance results from the patients will be compared with the results from~     the classical rehabilitation applications by the standards of The International~     Classification of Functioning (ICF). These games will provide complete Turkish language~     support for the extended national dissemination of the project outputs.~      The proposed project is inherently a multi disciplinary work that requires very close~     interaction of phisiotherapists, software experts, and HCI specialists and efficient~     application of the these games for the patients. There will be specialized games for each~     disorder. These games will utilize the outputs from the Leap Motion device that will produce~     3D hand joint positions and joint angles. Realistic animations of hand and virtual~     environments will provide a motivating exercise game platform for the patients.The~     performance measurements of the patients will be repeated for each game session. There will~     be game parameters for the game duration, difficulty level, and hand joints in focus. The~     game hand movements will reflect daily life activities for the rehabilitation purposes which~     would make our games different from the general public games. The project findings at end of~     the project on best game usage frequency and durations, the effectiveness of the designed~     VBG's and other results will be shared with the scientific community through publications and~     seminars.~   "
37255|NCT03078985|"~     The purpose of this clinical study is to assess the safety and performance of the Vision-MR~     Ablation Catheter, the primary safety endpoint will measure the rate of serious adverse~     events related to the device or procedure; the primary performance endpoint will measure the~     acute success rate defined as the demonstration of bidirectional cavo-tricuspid isthmus block~     after radiofrequency application in the cavo-tricuspid isthmus; the secondary performance~     endpoint will measure the chronic success rate defined as the freedom of recurrence of type 1~     atrial flutter at three months post-ablation procedure. The study will be a single center~     study conducted at the Leipzig University Hospital Heart Center in Germany. The study~     population will consist of adult patients requiring ablation for type I atrial flutter.~      This is the follow-up study to NCT02699034.~   "
37256|NCT03078972|"~     This study will evaluate how the cardiovascular system interacts with mechanical hearts to~     provide blood flow to the body during exercise. Two aims are proposed: 1) to determine the~     impact of a mechanical heart on exercise pressor reflexes in heart failure patients; and 2)~     to define the primary determinant(s) of exercise capacity in heart failure patients before~     and after device implantation.~   "
37257|NCT03078959|"~     This is an observational retrospective study. The primary objective is to investigate the~     expression and potential prognostic role of Programmed Death Ligand 1 (PD-L1) in tumor~     samples from 350 patients with early stage treatment-naive non-small-cell lung cancer~     (NSCLC).~      Tissue samples were embedded in a tissue microarray. PD-L1 will be studied by~     immunohistochemistry using the SP263 antibody. Stained samples will be evaluated~     independently by two operators. A tumor will be defined as positive when = or >50% of tumor~     cells express the ligand.~      The investigators will investigate the relationship between PD-L1 protein expression and~     overall survival and other clinical characteristics with appropriate statistical methods.~   "
37285|NCT03078595|"~     Von Willebrand disease (VWD) is the most common inherent bleeding disorder resulting in~     prolonged bleeding time. Gingival bleeding is a frequently reported symptom of VWD. However,~     gingival bleeding is also known as a leading symptom of plaque-induced gingivitis and~     untreated periodontal disease. Gingival bleeding in VWD patients may be triggered by gingival~     inflammation and not a genuine symptom. Thus, this study evaluates whether type 2 and 3 VWD~     determines an increased susceptibility to gingival bleeding in response to the oral biofilm.~   "
37258|NCT03078946|"~     This randomized double-blind parallel clinical study was conducted on 60 patients undergoing~     elective cardiac surgery under general anesthesia, at least 60 yr old, ASA I and II, 70-100~     kg body weight and height 160-180 cm. Patients were randomized to: group A=30 patients~     receiving dexmedetomidine infusion (0.4- 0.7 µg /kg/h) or group B= 30 patients receiving~     morphine in a dose of 10-50μg/kg/hr as an analgesic with midazolam in a dose of 0.05mg/kg up~     to 0.2 mg/kg repeated as needed. Titration of the study medications infusions was conducted~     to maintain light sedation (RASS) (-2 to +1). Primary outcome was the prevalence of delirium~     measured daily via Confusion Assessment Method for intensive care. If Delirium and agitation~     occurred: haloperidol 2.5-5 mg IV was given in repeated boluses. Secondary outcomes included~     ventilation time, additional sedation/analgesia, hemodynamics and adverse effects.~   "
37259|NCT03078933|"~     The clinical trial will assess the delivery of Nitric Oxide topically to the diabetic foot~     ulcer wound and the surrounding wound area as it related to wound healing.~      The objective of the study is to assess the Nitric Oxide Therapy treatment time (the number~     of minutes to deliver the treatment) and frequency (number of days per week to treat) to~     determine the most optimal treatment time and frequency to develop a rationale for safety and~     efficacy for the final APT001 clinical study.~   "
37260|NCT03078920|"~     The objective is to investigate the new Naida CROS device in adult recipients including~     chronic phases and to generate some preliminary pre-launch data.~      The formal study objectives are to compare the speech intelligibility in quiet and noise when~     using the CROS device with the Naida CI Q70 processor versus the Naida CI processor alone in~     quiet and noise conditions. Subjects will be tested with and without CROS at the baseline~     visit and then at follow-up visits taking place one month and three months after baseline.~     Subjects will use the new device at home between the first two visits appointments and then~     will only use the Naida CI processor for two additional weeks to better evaluate the handicap~     of not having access to contralateral signal input. There will be four visits to the centre~     in total.~      Subjective feedback will be collected through questionnaire like the APHAB and Speech,~     Spatial and Qualities of Hearing Scale (SSQ). A customised questionnaire focusing usability~     and benefit of the CROS will also be administered.~      Additional interest of the study will be to evaluate any acclimatisation effect with the CROS~     device both objectively and subjectively.~   "
37261|NCT03078907|"~     The primary objective of this study is to evaluate the effect of selexipag on the physical~     activity of patients with pulmonary arterial hypertension (PAH) in their daily life, by using~     a wearable wrist device (actigraph). The actigraph will collect data on daily life physical~     activity in the patient's real environment. In addition, the PAH symptoms and their impacts~     will be assessed by using an electronic patient reported outcome measure in the patient's~     real environment. Patients will be assigned randomly to either selexipag or placebo.~   "
37262|NCT03078894|"~     Tropical diseases are continuously on the rise throughout the world as they are spreading and~     manifesting in various locations globally. The more prominent vector tends to be the mosquito~     after it bites a previously infected host. The viruses of Zika, Chikungunya, and Dengue are~     some of the tropical diseases that are affecting large populations and expanding rapidly.~     Developing countries are at the highest risk because of the lack of preventive methods that~     are customarily demonstrated in developed countries. Sanitation issues complicate the problem~     as contaminated wastewater is ideal for mosquitos to lay eggs. In addition, the organic~     material in the wastewater serve as food for larvae. The purpose of this study is to test~     bodies of waters in Peru and examine if contaminated water is a contributing factor in the~     proportion of the population infected with Zika, Chikanguyna or Dengue.~   "
37263|NCT03078881|"~     This is a Pre-Phase 1 prospective, non-interventional clinical assessment study to evaluate~     Crigler-Najjar syndrome subjects requiring daily phototherapy, aged 1 year and older.~   "
37264|NCT03078868|"~     To determine whether DW-MRI is applicable in the evaluation of post-operative collections,~     and whether utilization of DW-MRI can enhance application of percutaneous drainage and~     prevent unnecessary drainage.~   "
37265|NCT03078855|"~     Despite strong evidence suggesting that vitamin D deficiency is associated with undesirable~     outcomes in patients with numerous cancers, there has never been a thorough study of vitamin~     D treatment in subjects undergoing treatment for cancer. The purpose of this study is to~     evaluate whether modification of vitamin D levels in the blood, through supplementation, can~     improve outcomes.~   "
37266|NCT03078842|"~     Diarrhoea continues to be a major cause of child deaths. Current treatment of acute watery~     diarrhoea includes oral rehydration solution (ORS), zinc and continued feeding. The use of~     zinc is based on a number of studies that showed that zinc reduces the duration and severity~     of diarrhoea. The recommended dose of zinc in 6-59 month old children is 20mg/day for 10-14~     days. This dose is associated with an increased risk of vomiting. No dosing studies are~     available to determine the optimal dose of zinc, which while maintaining the benefits also~     has a low risk of vomiting.~      The investigators will conduct a double-blind randomized controlled trial of three doses of~     zinc (20mg/day, 10mg/day and 5mg/day) in two settings - one in Sub-Saharan Africa and the~     other in South Asia. The study population will be 4500 children with diarrhoea of less than~     72 hours duration who are aged 6-59 months. They will be recruited from outpatient health~     facilities. All enrolled children will receive ORS and continued feeding as recommended by~     the World Health Organization. Those allocated to the standard zinc dose will receive an oral~     dispersible tablet with 20mg zinc daily for 14 days. Those allocated to lower dose zinc will~     receive identical tablets with either 10mg or 5mg zinc daily for 14 days. Enrolled children~     will be followed by until recovery from diarrhoea or 15 days after enrolment, whichever is~     later. In addition, study children will be assessed again at thirty (30), forty-five (45),~     and sixty (60) days to estimate impact on post illness outcomes. Primary outcomes will be~     mean duration of diarrhoea, proportion of episodes that last longer than 5 days, mean number~     of stools and proportion of children with vomiting.~   "
37286|NCT03078582|"~     The purpose of the study is to evaluate the safety and efficacy of RA101495 in patients with~     Paroxysmal Nocturnal Hemoglobinuria (PNH). There will be two groups of patients in the study:~     the first group will include patients who have never received eculizumab for treatment of~     PNH. The second group will include patients who have received treatment with eculizumab for~     at least 6 months prior to the study. Patients will be treated with RA101495 for 12 weeks.~   "
37267|NCT03078829|"~     Background: The QT interval of the electrocardiogram (ECG), corrected for heart rate (QTc),~     is a measure of the duration of ventricular repolarization and is a widely used marker of~     ventricular arrhythmia risk. Testosterone has a shortening effect on QTc length, and the QTc~     interval in males is shorter than in females after the onset of puberty. Transgender female~     adolescents are treated with GnRH agonists or spironolactone that suppress endogenous~     testosterone secretion and might increase the QT interval sufficiently to increase the risk~     for malignant ventricular arrhythmias. There are no current guidelines regarding monitoring~     QTc interval in transgender females undergoing GnRH agonist treatment.~      Objective: To assess the effect of GnRH agonist treatment on QTc interval in transfemale~     youth.~      Methods: A quasi-experimental time series study of transgender female adolescent, seen at~     UCSF Child and Adolescent Gender Center (CAGC) during 2017-2019.~      Specific aims:~      To assess the impact of GnRH agonist treatment on QTc interval length in transgender female~     adolescent~   "
37268|NCT03078816|"~     Dystonia is a movement disorder seen in both children and adults that is characterized by~     sustained or intermittent muscle contractions causing abnormal, often repetitive, movements,~     postures, or both. Secondary dystonia is far more common in pediatric populations than~     primary dystonia, and far more recalcitrant to standard pharmacologic and surgical treatments~     including Deep Brain Stimulation (DBS). There exists a large unmet need to develop new~     therapeutics, treatment strategies, and outcome measures for pediatric secondary dystonia.~      The investigators are proposing to investigate the ventralis oralis posterior nucleus (Vop)~     of the thalamus as a new target for DBS in secondary dystonia. Prior to the development of~     DBS, the main surgical treatment of dystonia was thalamotomy. Although there were many~     different targets in the thalamus, often done in staged procedures, the most common and~     successful targeted nuclei was the Vop, which is traditionally thought to be the pallidal~     receiving area. Previous lesioning of Vop produced improvements in dystonia but intolerable~     side effects, especially when implanted bilaterally. However, given that secondary dystonia~     patients were often reported to have superior results to primary dystonia it is reasonable to~     believe that if the side effects can be modulated, that targeting of the Vop nucleus with DBS~     could be a viable alternative to Globus Pallidus interna (GPi). Given that Deep Brain~     Stimulation is a treatment that is inherently adjustable, it is conceivable that settings on~     the Deep Brain Stimulation could be adjusted to allow for clinical benefit with minimal side~     effects. Indeed, there have been several scattered successful case reports attesting to this~     possibility.~   "
37269|NCT03078803|"~     To determine the efficacy and safety of serial FMT at inducing and maintaining clinical and~     endoscopic response in patients with mild to moderate Crohn's disease~   "
37270|NCT03078790|"~     Preoperative anxiety is a common occurrence for many patients undergoing all types of~     surgery. Patients with a high level of anxiety before surgery have been shown to have~     numerous negative outcomes both intra-operatively and post-operatively. Many studies have~     shown that preoperative psychological interventions that aim to reduce anxiety also result in~     improved post-operative behavioral and clinical recovery. Currently, the most common method~     to treat preoperative anxiety is the administration of a prescription benzodiazepine.~     However, there is limited clinical evidence that supports the use of sedative premedication,~     such as with a benzodiazepine, before surgery. Complementary integrative medical therapies~     including music, massage, guided imagery, and deep breathing have been proposed to minimize~     stress and pain in surgical patients. These therapies are thought to be effective by evoking~     the relaxation response through stimulation of the parasympathetic nervous system and~     engagement of the patient in the healing process. Relaxation and deep breathing,~     particularly, have been shown to reduce pain, anxiety, and tension-anxiety in hospitalized~     patients. Based on this evidence, a guided paced deep breathing module has been proposed to~     reduce preoperative anxiety in patients undergoing gynecological surgery at Mayo Clinic~     Rochester Methodist Hospital. In this study, patients' anxiety will be assessed~     pre-intervention on a 0-10 numeric rating scale, as well as post-intervention and a paired~     t-test will be used to assess effectiveness. Additionally, qualitative questions will be~     administered via a questionnaire post-intervention to gain more insight on the effectiveness~     of the intervention. The feasibility of the intervention in the busy preoperative setting~     will be evaluated by assessing how many times a patient is interrupted while participating in~     the paced deep breathing module. If this module is found to be effective in reducing~     patients' anxiety, it will be implemented into practice so that every patient undergoing~     gynecological surgery, at the institution, will be offered the module preoperatively.~   "
37271|NCT03078777|"~     The Investigators recently completed and published a study that demonstrated that~     fexofenadine pharmacokinetics are significantly altered in dialysis patients (Thomson et al.~     (2015) American Journal of Kidney Diseases 65(4):574-582). In this study, patients were~     studied directly before routine dialysis treatment. Other published literature suggests the~     timing of the dose of some drugs (before or after dialysis) may have a profound impact on the~     drug pharmacokinetics (Nolin et al (2006) 17(9):2363-7). The hypothesis is that compounds~     that accumulate in the blood of patients with kidney failure impact the pharmacokinetics such~     that dosing before or after dialysis produces significantly different blood levels of the~     drug.~   "
37272|NCT03078764|"~     This project explores the feasibility of using automated telephone calls to adult patients~     with type 2 diabetes to improve diabetes self-management in Thailand. This line of work could~     significantly extend Thai nurses' ability to manage this growing epidemic, and ultimately~     reduce the suffering and costs caused by diabetes in Thailand.~   "
37273|NCT03078751|"~     This is an international, multi-center, randomized, double-blinded, placebo-controlled~     clinical study evaluating the efficacy and safety of ribociclib with endocrine therapy as an~     adjuvant treatment in patients with hormone receptor-positive, HER2-negative, high risk~     breast cancer.~   "
37274|NCT03078738|"~     The aim of this first-in-human study is to assess the safety, tolerability, PK and~     exploratory pharmacodynamics (PD) of single and multiple oral ascending doses of OMT-28 in~     healthy male subjects to support further clinical development of OMT-28 in the indication of~     atrial fibrillation (AF) and to obtain data on food and gender effects of OMT-28 to guide~     dosing for Phase II trials.~   "
37275|NCT03078725|"~     A pragmatic, comparative effectiveness trial of glyburide versus metformin.~   "
37287|NCT03078569|"~     This study evaluates the efficacy of pre- IVF treatment with transdermal testosterone to~     enhance ovarian response in poor responders.~      a randomized controlled trial with two groups, treatment group with transdermal testosterone~     before IVF treatment and a control group with no treatment.~   "
37330|NCT03078010|"~     The purpose of this study is to see how different antibiotics affect the community of~     friendly bacteria existing in the intestinal tract (gut). Under normal circumstances, these~     friendly bacteria are not harmful and they help with normal bodily functions such as~     digestion. When these bacteria are absent, several complications may occur, such as~     infections with harmful bacteria or other inflammatory reactions, that can complicate the~     stem cell transplant course. Treatment with antibiotics or chemotherapy is known to kill off~     these friendly bacteria. In this study we compare the effects of different antibiotics on the~     community of friendly bacteria in the gut.~   "
37276|NCT03078712|"~     Septic shock is a highly lethal condition associated with a mortality risk of 30 to 60%.~     Optimizing tissue perfusion and oxygenation is the aim to decrease mortality and morbidity in~     septic shock patients.~      Persistent hyperlactatemia after initial resuscitation is particularly difficult to~     interpret, although optimizing systemic blood flow might reverse ongoing hypoperfusion.~     Nevertheless, if persistent hyperlactatemia is caused by non-hypoperfusion-related~     mechanisms, then sustained efforts aimed at increasing cardiac output (CO) could lead to~     detrimental effects of excessive fluids or inotropes. Another potential alternative~     resuscitation target is peripheral perfusion as assessed by capillary refill time (CRT),~     mottling score or central-to-toe temperature differences. Reversal of abnormal peripheral~     perfusion might represent improvement in tissue hypoperfusion with the advantage of a faster~     recovery than lactate.~      Hypothesis: Peripheral perfusion guided resuscitation in septic shock is associated with~     lower mortality, less organ dysfunctions, less mechanical ventilation (MV), less vasopressor~     load, and less renal replacement therapies than a lactate-targeted resuscitation strategy.~      Main Objective To test if peripheral perfusion targeted resuscitation in septic shock is~     associated with lower 28-day mortality than a lactate targeted resuscitation.~      Design: Multicenter, Parallel Assignment randomized controlled study, conducted under~     supervision of an independent Data Safety Monitoring Board (DSMB).~      Interventions:~        1. Active Comparator- Peripheral Perfusion guided resuscitation~        2. Active Comparator- Lactate guided resuscitation~      Randomization: 1:1 the randomization using a block size of eight will be stratified according~     to participating centers.~      Trial size: 400 randomized patients in 30 ICUs.~   "
37277|NCT03078699|"~     For patients with unresectable or recurrent disease, radiation is routinely administered,~     often in combination with systemic chemotherapy. However, because of wide range of radiation,~     more complications of conventional radiotherapy limit its treatment dose. The local~     recurrence rates of conventional radiotherapy are dissatisfied.Stereotactic body radiation~     therapy(SBRT) well solved the problem above. On the one hand, by improving the single dose,~     it not only shortens the total radiation treatment, but also increases the total dose of~     equivalent biological effects.~   "
37278|NCT03078686|"~     The primary objective of this study is to evaluate the safety and efficacy of the use of a~     biocellular mixture of emulsified adipose-derived tissue stromal vascular fraction (AD-tSVF)~     and high density platelet-rich plasma concentrate (HD- PRP). Additionally, comparison with~     clinical outcomes of adipose-derived cellular Stromal Vascular Fraction (AD-cSVF) + AD-tSVF +~     HD PRP; AD-cSVF + emulsified AD-tSVF + HD- PRP; emulsified AD-tSVF + HD PRP + AD-cSVF;~     AD-cSVF via intravenous infusion in treatment of Scaring Alopecias and Alopecia Areata.~     Control will be served by use of established clinical protocol of using platelet concentrates~     with Matristem Matrix (Acel) injected in the same fashion as the other ARMs within this~     study, and comparative analyses performed at the endpoint of this study.~   "
37279|NCT03078673|"~     Will motor skill- and/or strength training affect technique, work economy and time~     performance in cross-country poling? Competitive cross-country skiers (age 16- 30) will~     perform a 10 weeks training intervention. They will be randomized in one of the following~     three groups: poling specific motor skill training 3 times per week in addition to their~     regular training, maximal strength training 3 times per week in addition to their regular~     training and a control group who only perform their regular training. Pre- and post~     intervention, all participants will perform tests in VO2max (running), VO2max (poling), work~     economy (poling), video and inertial measurement unit (IMU) analyzes of poling technique,~     time performance test (poling), motor skill tests and maximal strength tests.~   "
37280|NCT03078660|"~     An innovative nutritional application (App) entitled MyNutriCart was developed to create a~     list of foods and beverages to help individuals make smart and healthy choices when~     purchasing foods at grocery stores based on the Dietary Guidelines for Americans. This App~     was tested in a pilot trial to evaluate its feasibility, usability, and acceptability for~     making smart and healthy choices when purchasing food in grocery stores and test its~     effectiveness in improving food selection, dietary patterns, and weight status compared with~     the traditional nutritional counseling.~   "
37281|NCT03078647|"~     Clinical Study to Evaluate the Performance of the Profound System for the Treatment of~     Cellulite.~   "
37282|NCT03078634|"~     Randomised controlled trial comparing standard outpatient clinic treatment with~     multi-disciplinary clinic treatment for functional gastrointestinal disorders. Patients will~     be followed up to end of clinic treatment and 12 months beyond the end of treatment.~     Symptoms, quality of life, costs to the healthcare system and psychological outcomes will be~     assessed.~   "
37283|NCT03078621|"~     This study is a single arm, single center trial to study the safety and efficacy of purified~     autologous bone marrow derived stem cells and mesenchymal stem cells for the treatment of~     children with cerebral palsy.~   "
37284|NCT03078608|"~     A cancer diagnosis is extremely stressful, emotionally challenging, and often life-altering~     for both patients and their loved ones. Although more than one-third of patients experience~     distress, doctors are typically at a loss as to how to help patients and their families~     manage these emotional challenges. Mindfulness-based programs, including meditation, are~     offered at major medical centers in the US and have been found to help reduce stress and~     improve quality of life among cancer patients. However, these classes often require 30+ hours~     of in-person instruction over 8 weeks, which is neither practical nor feasible for patients~     undergoing chemotherapy due to side effects and scheduling conflicts.~      This study will test whether an 8-week mobile app-based mindfulness program is accepted and~     useful for patients who have recently received chemotherapy and their loved ones. It will~     also test whether it is feasible to randomize participants into three groups: intervention,~     active control (receiving progressive muscle relaxation through the same app) and a wait list~     control group (will receive the meditation intervention 8 weeks later), so that a future~     study can test whether mindfulness intervention can help reduce stress and improve quality of~     life. Because many Americans own smartphone or tablet, an app that can teach stress reduction~     techniques at home or at infusion clinics has great potential to address emotional needs that~     providers often cannot.~      The study will also include caregivers of patients who have recently received chemotherapy as~     research has shown that caregivers tend to show high levels of stress and depression and~     worse physical health compared to non-caregivers. The negative effects of caregiving are most~     pronounced in caregivers of patients with cancer. However, little support is directed to~     caregivers as most medical attention goes toward the patients. The patient-caregiver~     relationship may serve as a source of mutual support and a surrogate for community, which is~     traditionally considered to be an essential ingredient for sustaining mindfulness practices.~      If this study is successful, it will justify a larger trial to determine if use of a~     mindfulness app is effective in reducing stress and improving quality of life for cancer~     patients and caregivers. If effective, this low-cost stress reduction strategy could be~     distributed and used for all types and stages of cancer patients and their caregivers,~     anywhere, any time, helping to improve the quality of life of the many individuals affected~     by cancer.~   "
39934|NCT03044002|"~     BIOTRONIK 4French for AMBulatory peripheral intervention. A multicenter, controlled trial~     comparing 4French versus 6French femoral access for endovascular treatment of lower-extremity~     peripheral artery disease in an ambulatory setting: BIO4AMB~   "
37288|NCT03078556|"~     This study aims to compare the bioequivalence of two experimental fixed dose combination~     (FDC) tablets versus single entity products of dolutegravir (DTG) and lamivudine (3TC) in~     healthy adult subjects. The study will be carried out in two parts. Part 1 of the study will~     be open label, up to 3 periods design with a wash out period of at least 7 days between~     treatment periods. Subjects will be randomized to receive either single entities or~     formulation 1 FDC of DTG and 3TC in a crossover manner in first 2 periods. The first 16~     subjects who complete the first two treatment periods and consent to continue will receive a~     single dose of FDC formulation 1 tablet administered with a high fat meal for a third~     treatment period. In Part 2 of the study, subjects will be randomized to receive either~     single entities or formulation 2 FDC of DTG and 3TC in a crossover manner in first 2 periods.~     Similarly the first 16 subjects will then receive FDC formulation 2 tablets with high fat~     meal in treatment period 3. Subjects will have a follow-up visit within 7-14 days after the~     last dose of study drug. Approximately 76 healthy subjects will be included in Part 1 of the~     study and if Part 2 of the study is conducted, another 76 healthy subjects will be included.~     The total duration will be approximately 11 weeks.~   "
37289|NCT03078543|"~     The ANTHEM™ Total Knee System is being conducted to demonstrate non-inferiority of 10 year~     implant survivorship in patients undergoing total knee arthroplasty for osteoarthritis~     compared to reported literature~   "
37290|NCT03078530|"~     The overall objective is to determine whether Visbiome will improve~        1. intestinal symptoms of Irritable Bowel Syndrome (IBS) and~        2. non-intestinal symptoms (fatigue, joint pain, insomnia, general stiffness and headache)~          associated with IBS. All of these symptoms are part of the Gulf War (GW) illness.~   "
37291|NCT03078517|"~     Investigators aim to compare two supraglottic airway devices; the i-gel and the newly~     developed laryngeal mask airway protector in terms of airway sealing effect, the insertion~     success rate, and the incidence of complications in anesthetized patients.~   "
37292|NCT03078504|"~     Purpose of this study is to evaluate the short-term hemodynamic effects of changes in blood~     flow rates in critically ill patients receiving continuous renal replacement therapy.~   "
37293|NCT03078491|"~     This is a study to assess the effectiveness of CGM (Continuous Glucose Monitor), enhanced by~     a diabetes management platform (DMP), collectively called enhanced CGM (eCGM), in the care of~     older patients with T1D. The DMP includes an automated data transfer from CGM,~     insulin-delivery devices, and activity tracker to a clinical decision support system (CDS)~     that provides dosing adjustment recommendations based on that data to the healthcare team. In~     addition, the DMP includes on-demand education for patients and caregivers, and an interface~     for communication between providers, patients, and their caregivers.~   "
37294|NCT03078478|"~     This trial is conducted in Europe and North America. The aim of the trial is to compare the~     efficacy and safety of insulin degludec and insulin glargine 300 units/mL in subjects with~     type 2 diabetes mellitus inadequately treated with basal insulin with or without oral~     antidiabetic drugs. Due to change in glycaemic data collection process, this trial is amended~     to allow for a full 36 weeks (maintenance 2 period) of the use of the new process.~   "
37295|NCT03078465|"~     To determine the safety and efficacy of Ticagrelor versus Clopidogrel for the reduction of~     adverse cardiovascular outcomes in patients with high platelet reactivity on clopidogrel~     after successful implantation of coronary drug-eluting stents.~   "
37296|NCT03078452|"~     Since the introduction of the Jamshidi needle in 1971, new advances in bone marrow sampling~     have not been seen. In 2007, a new battery-powered bone marrow biopsy system was developed.~     This technology, using a battery-powered drill to operate the needle accessing the posterior~     iliac bone, was approved by the Food and Drug Administration (FDA) and is currently~     commercially available.~      Few randomized controlled trials (RCTs) have compared the use of the battery-powered bone~     marrow biopsy system to the Jamshidi needle (the traditional manual) method of bone marrow~     sampling. This research study is designed to evaluate the effectiveness of the Jamshidi~     needle compared to the battery-powered bone marrow biopsy system.~      100 participants will be enrolled in this study at Emory University.~   "
37297|NCT03078439|"~     Epipage 2 (epidemiologic study on small-for-gestational-age children) is a nationwide study~     implemented to improve our knowledge of the outcome of preterm children in France. This study~     was launched on March 28, 2011 and includes three groups of preterm children, all born before~     35 weeks: extremely preterm infants (born between 22 and 26 completed weeks of gestation),~     very preterm children (born between 27 and 31 completed weeks) and moderately preterm~     children (born between 32 and 34 completed weeks).~      These children are being studied from their birth up to the age of 12 years. At birth, data~     on maternal and infants' characteristics were collected from medical records. At one and two~     years, questionnaires sent to families and to physicians (at two years only) allowed to~     collect data about the children's life and health.~      At five and a half years, medical and psychological assessments are specifically implemented~     for the study in order to evaluate motor and cognitive disorders in this population.~   "
37298|NCT03078426|"~     High resolution computed tomography (HRCT) plays a major role in the management of idiopathic~     pulmonary fibrosis (IPF) by identifying characteristic lesions of usual interstitial~     pneumonia (UIP). Though HRCT is the standard reference to describe pulmonary structural~     alterations using a non invasive technique, it is nonetheless a radiating exam which provides~     limited functional information regarding inflammation. In this trial, the investigators aimed~     to evaluate whether MRI (Magnetic Resonance Imaging) using ultra-short echotime could be an~     alternative to HRCT in the assessment of the four morphological criteria required to define~     an UIP pattern. The investigators also planned to study the clinical value of the additional~     informations derived from MRI such as contrasts and lung perfusion using functional MRI.~   "
37299|NCT03078413|"~     The investigators proposed to review the exercise tolerance, cardiac function, and quality of~     life in patients born with transposition of the great arteries that have undergone surgery~     with either the Mustard or Senning procedure. Participants will complete a questionnaire. The~     investigators will review the participants' recent cardiac function testing which will assess~     their current health status. These tests include an echocardiogram, a metabolic exercise~     stress test, cardiac imaging, and a 24-hour Holter monitor. This collection of testing~     results will be compared specifically with previously acquired data during the first phases~     of this study (published in 2001 and 2007).~   "
37305|NCT03078335|"~     Babies that get an infection after 3 days of age while in the Neonatal Intensive Care Unit is~     not related to their delivery but to the hospital environment. Preventing these infections~     results in shorter hospital stays for babies, less risk of long term health problems and less~     health care resources required to care for them. Hand washing alone doesn't remove all~     bacteria from the hands of healthcare workers, and studies have shown that infections in~     adults and children admitted to hospital decrease if health care providers use clean, non-~     sterile gloves when treating patients. The main focus of this study will be to find out if~     using gloves when caring for newborns in the NICU is better than washing hands alone.~     McMaster Children's Hospital and The Hospital for Sick Children will be the pilot sites to~     participate in a future larger study where some infants will be cared for using non-sterile~     gloves, and others will be cared for using the standard hand washing method.~   "
37306|NCT03078322|"~     The study will evaluate the safety and efficacy of AV-101.~   "
37307|NCT03078309|"~     Medical Marijuana is used widely, and its effects on the visual system and the function of~     the retina have not been investigated thoroughly. Some evidence suggests that cannabinoids~     may be beneficial in certain degenerative diseases of the retina.~      The purpose of the study is~        1. To determine whether cannabis derivatives affect the visual functions in healthy adults~        2. To examine the effect of cannabis derivatives on the retina of retinitis pigmentosa~          patients~   "
37308|NCT03078296|"~     This study seeks to determine the burnout rate among minimally invasive gynecologic surgeons~     (MIGS) as well as to evaluate other personal, professional, and psychosocial factors~     associated with this condition.~      An anonymous electronic survey will be sent to the American Association of Gynecologic~     Laparoscopists (AAGL) members. The survey will contain items that will inquire about~     socioeconomic background, professional characteristic, and about physical and psychologic~     well-being.~   "
37309|NCT03078283|"~     This is a small-scale study of the effects on microbes in the human gut of adding high-fiber~     snack foods to usual diet. The snack foods are being provided by Mondelez International, Inc.~     Eight pairs of dizygotic twins, discordant or concordant for obesity, will participate in the~     study. They will complete 3 successive experiments in which their regular diet is~     supplemented by consumption, over a 6-week period, of high-fiber snack foods. Each experiment~     will involve (i) two weeks consuming regular diet (fecal sample collected weekly); (ii) one~     week consuming one snack food per day (approximately 7 g fiber, collection of all fecal~     samples), (iii) one week consuming two snack foods per day (approximately 14 g fiber,~     collection of all fecal samples), (iv) four weeks consuming three snack foods per day~     (approximately 20 g fiber, collection of all fecal samples); and (v) two weeks consuming only~     regular diet (weekly collection of fecal sample). For each experiment, participants will also~     provide a fasting blood sample during the free diet phase at the end of the week just before~     initiation of snack consumption, and a fasting blood sample at the end of the last week of~     snack consumption. Participants will also collect one first morning urine sample weekly~     throughout the study. During week 2, participants will also collect first morning urine~     samples for 3 consecutive days. Similarly, they will collect first morning urine samples for~     the last 3 consecutive days of the last week of snack consumption. The study will test the~     effects of the different fiber-rich snacks on the composition and metabolic properties of the~     gut microbial community in lean and obese subjects.~   "
37310|NCT03078270|"~     The goal of this study is to see whether Botox is an effective treatment for social anxiety~     disorder (SAD). Participants will complete two short surveys on depression and anxiety~     symptoms, receive a one-time injection of Botox, and complete the depression and anxiety~     survey 4 weeks after injection and again at 8 weeks after injection.~   "
37311|NCT03078257|"~     Antiplatelet treatment is important for coronary artery disease(CAD) patients .Some patients~     are resistant to antiplatelet treatment based on platelet function tests(PFT).Currently the~     results of PFT are mainly based on the analysis of peripheral blood. instead, adverse~     cardiovascular events in CAD patients may be more directly related to platelet activities in~     the coronary arteries. There's no evidence of system study to prove the PFT of peripheral~     blood can represent the platelet functions in coronary arteries.The purpose of this study is~     to determine the different platelet activities in the blood of peripheral vein (PV),~     peripheral artery (PA), intracoronary artery (IC) in the CAD patients without or with~     different interventions.~      our study is divided into three parts: Part A: To study the different platelet activities in~     the blood of PV, PA, IC in the CAD patients with dual antiplatelet therapy.~      Part B: To explore the different platelet activities of the above three sites in ST-segment~     elevation myocardial infarction (STEMI) patients who are administrated platelet membrane~     glycoprotein Ⅱb/Ⅲa (GPⅡb/Ⅲa) receptor antagonist ( tirofiban ) in PV or IC and dual~     antiplatelet therapy.~      Part C: To explore the different platelet activities of the above three sites in STEMI~     patients who are administrated antiplatelet thrombolysin or placebo in PV and dual~     antiplatelet therapy.~   "
37312|NCT03078244|"~     Project aims to determine the number of individuals with treatment resistant hypertension and~     to define the characteristics of these patients and estimate disease frequency. The study~     will be a retrospective review of medical record data based upon de‐identified information~     and will require no patient contact.~   "
37313|NCT03078231|"~     More than 29 million people in the US are living with diabetes, many of whom will develop~     diabetic retinopathy (DR) or diabetic eye disease (DED), the leading cause of vision loss and~     blindness in working-age adults. Annual eye screening is recommended for all diabetic~     patients since vision loss can be prevented with laser photocoagulation and anti-VEGF~     injections if DR is diagnosed in its early stages. Currently, the number of clinical~     personnel trained for DR screening is orders of magnitude smaller than that needed to screen~     the large, growing diabetic population. Therefore, to meet this large unmet need for DR~     screening, a fully-automated computerized DR screening system is necessary. This study is~     designed to assess the performance of EyeArt, an automated DR screening tool.~   "
37314|NCT03078218|"~     Persistant hypoxemia in the newborn confers, even isolated, an abnormal clinical situation,~     that needs to be addressed for an adequate diagnosis and an optimal treatment.~      If during the first hours of life, hypoxemia is frequent and often transient, beyond that, it~     is necessary to search the various etiological conditions such as a critical congenital heart~     disease (CCHD) or a non cardiac affection (sepsis, anemia, respiratory disease).~      Newborn pulse oximetry screening identifies babies with critical congenital heart disease~     (CCHD) based on the rational that they frequently have a degree of hypoxemia that may be~     clinically undetectable. CCHDs are life-threatening forms of congenital heart disease (CHD)~     occuring in 2-3/1000 live births but accounting for 3%-7.5% of infant deaths.~      Early detection is beneficial because of acute collapse, if not resulting in death, is~     associated with a worse surgical and neurodevelopmental outcome.~      Currently, screening for CCHD involves antenatal ultrasound scanning and post-natal physical~     examination. Although antenatal detection rates have improved over recent years and can be as~     high as 70%-80% in some centers, this is not consistent. Indeed, in Nouvelle Aquitaine~     overall <50% of CCHDs are detected before birth. In addition, up to a third of infants with~     CCHD may be missed on post-natal examination. Pulse oximetry screening can help to close the~     diagnostic gap' that is, increase the detection of babies who slip through the current~     screening net.~      Several large European studies and a subsequent meta-analysis have shown that pulse oximetry~     screening is a highly specific (99.9%) and moderately sensitive (76.5%) test which increases~     CCHD detection rates. The high specificity results in a low false-positive rate 0.05% to~     0.5%. But those babies with a Positive Test, if they may not have CCHD, they may be diagnosed~     with other causes of hypoxemia (congenital pneumonia, sepsis, persistent pulmonary~     hypertension,...). As with CCHD, delayed recognition of these conditions can result in~     postnatal collapse and significant morbidity and mortality. It is also more useful to~     consider these conditions as secondary targets of screening and to remember they constitute~     30%-70% of false positives. In 2011, the US Health and Human Services Secretary recommended~     that pulse oximetry screening for CCHD be added to the Recommended Uniform Screening Panel.~     In Europe, implementation is advanced in such countries as North European Countries, and~     Switzerland. There isn't yet any European guidance. In France, the implementation is limited~     to local and transient experiments. The feasibility, usefulness and cost-effectiveness of~     routine pulse oximetry screening have not been evaluated so far. The French setting has two~     specificities : 1/ the antenatal detection rate is considered to be rather high. 2/ in~     contrast to a lot of other European countries, early discharge from the maternity ward before~     48 hours of life is not common, decreasing the risk of discharging a baby with undiagnosed~     CCHD, but not saving babies from collapse.~      - The Investigators hypothesis is that routine pulse oximetry screening in asymptomatic~     newborns would allow to reduce the incidence of complications related to CCHDs as well as~     those related to non cardiac pathologies for a reasonable cost for the French Health Care~     System.~   "
37419|NCT03076853|"~     The aim of MATRIX-DPRS is to assess the clinical and organizational impacts of the use of the~     medication record, opened, filled and managed by pharmacists (from private office and~     hospital units) by hospital physicians in private and public healthcare establishments~     (volunteers), for three clinical contexts: anaesthesiology visit before surgery, medications~     abuse and emergency hospitalization, medications and elderly hospitalisations.~   "
37315|NCT03078205|"~     Objective: To evaluate the curative effect of TCM multi-channel interventional therapy on~     women with ART Failure; to compare the curative effect of the dual therapy and triple therapy~     on women with ART Failure; to choose the best TCM interventional therapeutic plan.~      Methods: The cases with ART Failure from West China second University Hospital of Sichuan~     University (West China Women's and Children's Hospital of Sichuan University) meeting the~     inclusion criteria were randomly divided into three groups: the dual therapy group, the~     triple therapy group and the control group, compare the natural pregnancy number, the~     condition during the period of secondary IVF-ET and the improvement of the kidney deficiency,~     liver depression and blood stasis syndrome among those three groups.~   "
37316|NCT03078192|"~     This study seeks to deploy several forms of 129Xe MRI contrast as well as emerging~     conventional proton MRI technqiues for imaging lung structure and perfusion. Specifically,~     the 129Xe MRI scans will provide 3D images of ventilation and gas exchange, and spectroscopic~     indices will be evaluated to test gas exchange dynamics with high temporal resolution. The~     conventional 1H MRI scans will include a free-breathing ultra-short echo time (UTE) scan that~     provides images similar to that of a CT scan. In addition, to characterize perfusion and~     vascular dimensions directly, patients will undergo a gadolinium-enhanced perfusion scan.~   "
37317|NCT03078179|"~     The objective of this study is to determine if the presence of bacterias with probiotic~     characteristics (Lactobacillus rhamnosus GG and Bifidobacterium longum) in a commercial milk,~     control some measures that indicate cariogenic processes.~   "
37318|NCT03078166|"~     Heart failure (HF) is a major health problem worldwide but there is no global HF study that~     documents demographics, socioeconomic and clinical factors, diagnostic and management~     patterns, etiology, biomarkers, co-morbidities, treatments, quality of life, barriers to care~     and outcomes in all parts of the world. Such knowledge is essential in the prevention and~     treatment of this global disease. The Global Congestive Heart Failure Registry (G-CHF) is a~     global registry of approximately 20,000-25,000 HF patients enrolled over approximately 5~     years to study these risks and causes of HF.~   "
37319|NCT03078153|"~     The purpose of this study is to determine if social media support and financial incentives~     improve adherence to Truvada as PrEP in African American, Latino and Asian MSM aged 18 to 24~     living in the Washington, DC area who are at high risk for HIV acquisition.~   "
37320|NCT03078140|"~     Pregnant women who attend at our antenatal clinic will random to 2 groups. First will receive~     routine iodine supplementation. The other will receive iodinated pill or only iron~     supplementation base on their urine iodine status.~   "
37321|NCT03078127|"~     This is a pilot study investigating the effectiveness and clinical efficacy of airway~     clearance therapy (ACT) in cystic fibrosis (CF). Enrolled subjects will undergo measurements~     of mucociliary clearance (MCC) and exhaled biomarkers at baseline and after 3 different forms~     of ACT: high frequency chest wall oscillatory vest, oscillatory positive expiratory pressure~     device, and whole-body vibration.~   "
37322|NCT03078114|"~     The purpose of this study is to examine the change of nervous system activity before and~     after spinal manipulation treatment program in people with low back pain.~   "
37323|NCT03078101|"~     This study will be a prospective, clinical pilot study in CKD patients to show whether~     Empagliflozin in addition to ACEi treatment significantly increases Ang 1-7 levels compared~     to ACEi treatment alone.~      Null and alternative hypotheses:~      H0: Empagliflozin in addition to ACEi treatment does not increase Ang 1-7 levels more than~     ACEi treatment alone.~      H1: Empagliflozin in addition to ACEi treatment significantly increases Ang 1-7 levels~     compared to ACEi treatment alone~      Methodology:~      Two groups of 24 chronic kidney disease (CKD) patients, respectively, with and without type 2~     diabetes will be randomized into the study medication or placebo group. The number of~     patients per treatment arms is n = 12. Included and consented patients will be subjected to~     an initial 2-week run-in period for conversion of current RAS blocking medications to ACEi~     therapy with enalapril or ramipril and respective dose titration to 10 mg enalapril 2 x daily~     and 10 mg ramipril 1 x daily. Additional antihypertensive medication will be standardized as~     feasible, with the primary goal of keeping blood pressure as recommended by KDIGO. Following~     the 2-week run-in phase, all study patients will be subjected to blood collection including~     the first RAS quantification (RAS Fingerprint) and assessment of HDL composition, as well as~     urinary analysis and bioimpedance fluid status assessment (BCM measurement). Subsequently,~     patients will be randomized to either receive empagliflozin (at a dose of 10 mg daily) or~     placebo. Subsequently, biweekly study visits including electrolyte and glucose (plasma and~     urine) monitoring as well as BCM measurement will take place. After 12 weeks of study~     medication intake, a concluding study visit will be scheduled for final RAS quantification~     (RAS Fingerprint) and HDL analyses as well as final blood and urinary analysis and BCM~     measurement. Initially, blood and urine will be collected at the clinical visit as part of~     the routine blood obtainment (no additional effort on patients). From these routine~     measurements we will be able to extract information regarding the patient's current CKD stage~     as well as other relevant laboratory parameters (e.g. HbA1c, UACR, etc.). Furthermore, we~     will document the patient's current medication and significant comorbidities.~      Primary analysis variable/endpoint:~      The difference of Ang 1-7 increase from baseline between a 3-month treatment with~     empagliflozin on top of ACEi treatment compared to ACEi treatment alone~      Most important secondary analysis variables/endpoints:~        1. Simultaneous quantitative changes of multiple RAS effector angiotensin levels determined~          by mass-spectrometry~        2. Recurrence of Ang II levels determined by mass-spectrometry~        3. HDL parameters (protein composition of HDL)~        4. Renal parameters (albuminuria reduction measured by urinary albumin-creatinine ratio~          (UACR), renal function (estimated glomerular filtration rate (GFR), serum-creatinine)~        5. Urinary electrolyte levels~        6. Urinary glucose levels~        7. Urinary RAS metabolites (angiotensinogen, ACE and ACE2 levels, ACE2 activity)~        8. Blood pressure determined by ambulatory blood pressure measurements~        9. Body volume determined by bioimpedance fluid status assessment (BCM measurement)~       10. OCR and ECAR in PBMCs determined by Seahorse Flux Analyzer~       11. Assessment of reduction of salt sensitivity by using salt sensitivity test with~          empagliflozin~   "
37324|NCT03078088|"~     The study will be a randomized, cross-over study of THAM followed by saline or saline~     followed by THAM in human non-CF and CF subjects to assess nasal colonization~   "
37325|NCT03078075|"~     This is a double-blind, placebo-controlled, randomized clinical trial evaluating the efficacy~     of extended-release naltrexone plus bupropion as a combination pharmacotherapy for~     methamphetamine use disorder. Participants will be randomly assigned to the active medication~     combination (AMC) group or matching placebo group and will receive medications over the~     course of 12 weeks. Follow-ups will occur in weeks 13 and 16.~   "
37326|NCT03078062|"~     The purpose of this study is to assess the effect of a single-dose of intravenous~     dexamethasone 8 mg on the duration of sensory and motor blockade following spinal anesthesia~     with isobaric bupivacaine.~      The hypothesis of the study is that intravenous dexamethasone will significantly prolong (by~     more than 20 minutes) the duration of spinal anesthesia.~   "
37327|NCT03078049|"~     Rationale: In order to compare the real-world use of commonly prescribed second-line oral~     diabetes therapies, real-world data comparing patients receiving treatment with dapagliflozin~     vs sitagliptin are needed, and limited resource use and cost data exist for patients~     initiating dapagliflozin in the real-world setting.~      Objectives:~      Primary: The primary objective of this study is to compare real-world health care resource~     utilization and costs following treatment with dapagliflozin versus sitagliptin. Secondary:~     The secondary objectives of this study are to assess clinical outcomes and treatment patterns~     among patients receiving treatment with dapagliflozin versus sitagliptin. Study Design:~     Retrospective cohort study. Target Subject Population: Patients receiving treatment with~     either dapagliflozin or sitagliptin will be evaluated.~      Study Variable(s):~      Primary Variables: Health care resource utilization and costs Secondary Variables:~     Demographics measured at the index date, Quan-Charlson Comorbidity score, measured during the~     baseline period, Agency for Healthcare Research and Quality (AHRQ)-based comorbidity~     measures, receipt of other antidiabetic medication classes during the baseline and follow-up~     periods, number and percentage of patients with a diagnosis of obesity during the baseline or~     follow-up periods, treatment patterns during the follow-up period (i.e., index dose, duration~     of treatment, discontinuation, adherence, receipt of additional antidiabetic medication~     classes), HbA1c outcomes (among subgroup of patients with linked laboratory data, sample size~     permitting), renal impairment, hypoglycemia as defined by a claims-based algorithm.~      Statistical Methods: Initial analyses will be descriptive in nature and entail the tabular~     display of mean values, medians, ranges, and standard deviations of continuous variables of~     interest (e.g., patient age) and frequency distributions for categorical variables (e.g.,~     sex, geographic location). Outcomes will be compared between patients receiving dapagliflozin~     versus sitagliptin using univariate tests. Propensity score matching will be undertaken to~     reduce bias in the comparison of patients receiving treatment with dapagliflozin versus~     sitagliptin. Following matching, demographics and baseline characteristics will be assessed~     using standardized differences to determine balance in the post-matched sample. Outcomes will~     be assessed using tests for paired data (paired t-tests, signed rank tests, McNemar's tests).~   "
37328|NCT03078036|"~     BREAKOUT -International Breast Cancer Biomarker, Standard of Care and Real World Outcomes~     Study BREAKOUT is a prospective cross-sectional cohort study of human epidermal growth factor~     receptor 2 negative metastatic breast cancer patients who have started 1st line systemic~     cytotoxic chemotherapy. The study will estimate the prevalence of germline breast cancer~     susceptibility gene in an otherwise unselected population, describe the treatments~     administered and estimate the associated clinical outcomes of overall survival and~     progression-free survival amongst mutation carriers within the context of a low poly ADP~     ribose polymerase inhibitor treatment setting. Other exploratory analyses may be undertaken~     to describe somatic breast cancer susceptibility gene and other homologous recombination~     repair gene mutations.~   "
37329|NCT03078023|"~     Are we able to use the EPO staining technique using the sponge ?~   "
37439|NCT03076580|"~     This is a multi-omics research of Chinese cardiomyopathies patients, aiming to determine~     genetic risk factor and serial biomarkers of cardiomyopathies in diagnosis and prognosis.~   "
37331|NCT03077997|"~     Diabetes distress is a psychological phenomenon associated with the self-management of the~     disease and is characterised by feelings of anxiety, guilt, helplessness, defeat, and~     depression. Research suggests that internet-delivered interventions have the potential to~     increase people's ability to self-manage their symptoms, but whether they are effective is~     largely unknown. This study is designed to investigate the potential effectiveness of an~     internet-delivered intervention for diabetes distress in patients with type 2 diabetes.~   "
37332|NCT03077984|"~     This project is one multi-center, a prospective cohort study, based on 1660 cases of ischemic~     stroke patients with the treatment of 3 months, and 21 months of follow-up observation in~     order to clarify the advantages and characteristics of integrated treatment of traditional~     Chinese medicine sequela of apoplexy; With the formation of curative effect, to highlight the~     advantage of the programme of comprehensive treatment of apoplectic sequela in traditional~     Chinese medicine and its compound preparation; To form a active medical service mode of~     stroke chronic disease management processes, as well as modalities and mechanisms for the~     evaluation of the curative effect.~   "
37333|NCT03077971|"~     This is a feasibility study to evaluate whether it is possible to conduct a larger study to~     evaluate whether providing psychological support to carers of people with MS is effective in~     reducing carer strain. Whilst not all carers experience distress as a result of their caring~     duties, some do. This study is testing the use of Acceptance and Commitment Therapy (ACT) in~     a self-help format. Participants will learn about and use ACT by reading a book provided to~     them by the study. One group will receive the ACT book, another will receive the same book~     alongside weekly telephone support to use the book, and a third group will act as a control~     group and therefore will not have extra support. Participants are allocated to the groups~     based on chance (a computer will decide group allocation). Participants will complete~     questionnaires before group allocation, and then again 3 months after they were allocated to~     a group, and one final time 6 months after group allocation. Those who receive the self-help~     book will get sent chapters each week for 8 weeks. The groups will be compared on scores from~     the questionnaires and complete feedback interviews with a subgroup of those who receive the~     book, to gain feedback about their experiences of the study.~   "
37334|NCT03077958|"~     100 knees with primary osteoarthritis and scheduled for a total knee replacement (TKR) will~     be recruited from our waiting list. The patients will be randomized to become operated with~     the Attune or PFC total knee arthroplasty. Randomisation will be done using envelopes.~     Patients can only participate with one knee.~   "
37335|NCT03077945|"~     1. PURPOSE OF THE STUDY 1.1 Justification The purpose of the project is to examine the~          effect of breathing biofeedback and thoughts about stress on performance under stress~          and cigarette cravings. Smoking rates in the United States have been steadily going down~          over the past 50 years, and now 16.8% of adults smoke (Centers for Disease Control and~          Prevention, 2015). Most smokers try to quit, but end up going back to smoking~          (Garcia-Rodriguez et al., 2013; Piasecki, 2006; Rafful et al., 2013). The reasons people~          go back to smoking may have something to do with stress in their lives, particularly for~          women who smoke. This study wants to see if we can reduce temporary stress and lower~          craving to smoke after stress.~           1.2 Description of the Research Project Approximately 60 adult women will participate in~          the study. Participants must be between 18 and 65 years old, able to read English~          fluently, and must agree to engage in the research procedures (stress protocol,~          physiological assessment, breathing training, questionnaires) to participate. People who~          are taking medications that interfere with physiological assessment are excluded from~          participating including people with: self-identified substance use problems,~          self-identified psychosis, morbid obesity (BMI>40), and people who take anti-cholinergic~          medication, beta blockers, Ritalin, benzodiazepines, tricyclic antidepressants or~          bupropion, varenicline, antipsychotic medication, or nicotine replacement therapy.~          People who have a cardiac rhythm abnormality or major neurological problem are also~          excluded from the study. Also, participants may not participate if they are pregnant or~          color-blind. Participation is strictly voluntary.~        2. PROGRESSION OF THIS STUDY 2.1 Procedures The study visit procedures will take place at~          the Emotion and Psychopathology Laboratory at Rutgers University, located at the Rutgers~          Institute for Health, Healthcare Policy, and Aging Research. Participants will first~          complete some questionnaires and provide some basic information about themselves~          (demographic information, responses to emotion and stress, and smoking history). Next,~          participants will engage in a baseline psychophysiological assessment where~          investigators will examine heart rate, breathing, and blood pressure. Next,~          investigators will either ask participants to sit quietly for 30 minutes while~          completing a computer task and watching short videos, or practice a specific deep~          breathing exercise for 30 minutes. Then participants will do three tasks on a computer.~          The tasks will ask participants to trace different shapes, answer math problems while~          receiving feedback about how they're doing, and identify colors and words on a screen.~          Finally, participants will be asked to sit quietly for 15 minutes before investigators~          remove the psychophysiological recording equipment. One week after the study visit,~          investigators will contact participants via phone to ask them some questions about the~          study visit.~      2.2 Duration of the study This study visit will last approximately 3 hours. Length of the~     visit may vary because each individual may complete procedures at a different pace. The phone~     call after the study visit will last approximately 10-15 minutes.~   "
37336|NCT03077932|"~     The investigators propose to develop a smartphone app (called OFFBup) that will help patients~     manage opioid withdrawal during buprenorphine taper and detoxification. The OFFBup smartphone~     intervention will be a resource patients can access anytime and anywhere. If the OFFBup~     intervention were to be effective in helping patients undergoing buprenorphine detoxification~     by decreasing relapse to illicit drug use, it could be integrated into the standard of care~     of office-based buprenorphine clinical practices, as well as methadone programs, thereby~     having a substantial public health impact.~   "
37337|NCT03077919|"~     This is a multisite, randomized, blinded, sham-procedure-controlled study to evaluate the~     efficacy of right-sided stellate ganglion block (SGB) on the acute symptomatology of Post~     traumatic Stress Disorder (PTSD), evaluated by the Clinician-Administered PTSD Scale (CAPS-5)~     clinical interview at pre-treatment and at 8 weeks. This entry describes the effectiveness~     study.The acceptability study is described in a separate entry.~   "
37338|NCT03077906|"~     Obesity surgery has become commonplace nowadays. This type of surgery is in full swing and~     although it is mostly beneficial for the health of the patient (reduction of cardiovascular~     risks, improvement of self image, reduction of osteo-articular risks, etc...) it is however~     associated with risks. There are several short and long term complications, excluding the~     ones related to the anesthesia and the post-op recovery: fistulas, abcesses, infections,~     dysphagia, risks of endobrachyoesophagus, etc...~      The gastroœsophageal reflux remains by far the most common post-op complaint within patients.~     Patients can experience symptoms as far as 3 years after the surgery. Medical treatment alone~     can in most cases lighten the symptoms. However, in some cases, this treatment fails and~     another type of surgery (bypass) must be undertaken, which is psychologically traumatic for~     the patient.~      This retrospective study will analyze a cohort of patients who underwent bariatric surgery~     (mainly sleeve gastrectomy), in order to identify those at risk of developping~     gastroœsophageal reflux and how this complication can be avoided in pre-op. The study will~     also identify cases of invalidating gastroœsophageal reflux that can be solved by obesity~     surgery.~   "
37339|NCT03077893|"~     A study to demonstrate the effectiveness of PEMF treatment compared to sham treatment in~     changing Vibration Perception Threshold (VPT) and Thermal Sensory (QST) in patients with~     diabetic peripheral neuropathy (DPN) when treatment is administered twice daily through~     120-day period.~   "
37340|NCT03077880|"~     The aim of this observational study is the evaluation of marginal bone remodeling after~     surgical implant placement, correlating the gingival thickness with the bone resorption rate.~   "
37341|NCT03077867|"~     This is set as prospective clinical trial to correlate histologically and radiologically the~     performance of four different bone grafts (synthetic hydroxyapatite alone, synthetic~     hydroxyapatite mixed with polylactic-polyglycolic acid, synthetic hydroxyapatite with i-PRF~     and inorganic bone graft) in the sinus floor elevation technique with lateral approach for~     the treatment of atrophic crests.~   "
37342|NCT03077854|"~     Thoracic radiotherapy (TRT) is a standard curative treatment for locally advanced,~     unresectable non-small cell lung cancer (NSCLC) and limited stage small cell lung cancer~     (SCLC). TRT has been recognized to cause moderate to severe lung injury in a substantial~     portion of patients. Conventional standard curative TRT planning techniques minimize the~     radiation dose to the anatomical lungs, without adaption of regional pulmonary function~     variations. The principal investigator hypothesized that preferential avoidance of functional~     lung during curative TRT may decrease the risk of pulmonary toxicity. Functional lung regions~     are identified using four- dimensional computed tomography for ventilation imaging. This~     randomized, single-blind trial will comprehensively assess the impact of functional lung~     avoidance on pulmonary toxicity, quality of life, and clinical outcome in patients receiving~     curative TRT for locally advanced NSCLC and SCLC.~   "
37343|NCT03077841|"~     The goal of this clinical research study is to learn about the side effects that may occur~     after radiation is given to breast cancer patients for 2 to 2½ weeks at the part of the~     breast where the disease first started. Researchers also want to learn if this treatment can~     help to control the disease and prevent the cancer from coming back in the breast.~      This is an investigational study. Radiation therapy will be delivered using FDA approved and~     commercially available methods. The shorter radiation treatment period is considered~     investigational. The study doctor can explain how radiation is designed to work.~      Up to 150 participants will be enrolled in this multicenter study.~   "
37344|NCT03077828|"~     The purpose of this research study is to evaluate a new drug Pembrolizumab in combination~     with chemotherapy, for Relapsed/Refractory Hodgkin Lymphoma. The chemotherapy regimen is~     called ICE and includes three drugs: ifosfamide, carboplatin, and etoposide. Pembrolizumab~     is currently Food and Drug Administration (FDA) approved for the treatment of some patients~     with melanoma, lung cancer and head and neck cancer, but has not yet been approved for the~     treatment of Relapsed/Refractory Hodgkin Lymphoma. The 'ICE' regimen of chemotherapy is~     currently FDA approved for the treatment of Relapsed/Refractory Hodgkin Lymphoma, but has not~     yet been investigated in combination with pembrolizumab for this disease. For patients who~     have a relapse of their Hodgkin's lymphoma, retreatment with chemotherapy followed by a stem~     cell transplant is recommended. We know that obtaining a complete remission (not able to~     detect any disease on scans) is very important prior to proceeding to the stem cell~     transplant. Patients with negative scans have a lower chance of the disease coming back and a~     higher chance of achieving a long-term cure.~   "
37345|NCT03077815|"~     Arm vein intermittently gripping arm movements, can promote the increased diameter of~     arteriovenous fistula, which enhance the maturity of fistula, the effect of lack of empirical~     research. Objective: this study, randomized controlled study, investigate systematic random~     arm vein pressure and arm movements to arteriovenous fistula in hemodialysis patients improve~     the maturity rate and effectiveness of the diameter. Methods: a prospective comparative study~     randomly assigned.~   "
37346|NCT03077802|"~     The investigators intend to compare the Seldinger technique and modified Seldinger technique~     on success rate and complications during central venous catheterization by a prospective,~     randomized, controlled study. The investigators are planning to compare both techniques in~     both experienced (anesthesiologist board member) and non-experienced practitioners (first and~     second-grade resident).~   "
37347|NCT03077789|"~     Evidence of a relationship between age at discovery of congenital glaucoma and visual acuity~     at 4 years of age.~      The delay in diagnosis is a factor of poor visual acuity. Will justify the implementation of~     information programs with health and education professionals in order to improve the~     functional prognosis of patients with congenital glaucoma.~   "
37348|NCT03077776|"~     A prospective multicentre study which aims to examine the relationship between intratumour~     heterogeneity (ITH) and pathological response to neoadjuvant chemotherapy in patients with~     histological confirmation of triple-negative breast cancer (TNBC) who are eligible for~     neoadjuvant chemotherapy.~   "
37349|NCT03077763|"~     The study is a pharmacodynamic random order cross-over trial investigating the physiological~     effects of intra-arterial infusion of nitrite following a haemolysed autologous blood~     transfusion.~   "
37350|NCT03077750|"~     A Multicenter, Randomized, Double-Blind, Vehicle-Controlled Phase II Study to Evaluate the~     Efficacy, Tolerability, and Safety of Topical VBP-245 in Pediatric Subjects for the Treatment~     of Molluscum Contagiosum (VBP-245-MCV).~   "
37351|NCT03077737|"~     Most smokers, especially those who are poor, do not receive smoking cessation treatment~     during their healthcare visits. This study is evaluating a novel population health management~     intervention for low-income smokers. Automated via an EHR system, which is bidirectionally~     linked with the Illinois Tobacco Quitline, the intervention comprises a mailed letter and~     text messaging designed to motivate low-income patients, most of whom are not ready to quit,~     to accept and use proactive quitline treatment. Increased access to free effective treatment~     via the integration of healthcare systems and state quitline services may be especially~     significant in its impact on low-income smokers who are underserved and who carry a much~     greater burden of tobacco-related disease.~   "
37352|NCT03077724|"~     The purpose of this feasibility study is to obtain pilot data in preparation for an upcoming~     R01 submission. The goals of that submission will be to conduct a clinical trial of n-3~     LCPUFAs for smoking cessation in pregnant women. For this proposal, the investigators will~     develop, test, and refine the recruitment strategy and collect data demonstrating the~     investigators ability to successfully recruit pregnant women who are actively smoking. The~     investigators will collect side effect, tolerability, and adherence data regarding the~     intervention. Finally, the investigators hope to gather preliminary effect size data to allow~     more formal estimates of sample size. The investigators hypothesize that pregnant smokers~     randomized to n-3 LCPUFA supplementation will have higher smoking cessation rates and less~     nicotine cravings compared to women allocated to placebo. The investigators intend to use~     this preliminary data to inform a future randomized, double-blind, placebo-controlled trial~     of n-3 LCPUFA supplementation for tobacco cessation.~   "
37393|NCT03077191|"~     This is an homogeneous, single institution, observational, non -interventional, prospective~     study of 500 patients who will be treated according to the standard protocol of adjuvant~     hypofractionated radiotherapy after breast conserving surgery, with forward-planned~     intensity- modulated radiation therapy (IMRT) to a total dose of 40 Gy/ 15 fr (5 fr/ week, 3~     consecutive weeks). In addition to the regular follow up, the patients will have to respond~     to the quality of life questionnaires (QLQ) of European Organisation for Research and~     Treatment of Cancer (EORTC), general, QLQ- C30, and specific for breast (BR), QLQ- BR23, at~     the first visit, at the end of radiotherapy ant then at the subsequent follow-up visits form~     6 months up to 5 years and a half, to evaluate the quality of life during and after the~     treatment. The study has also a retrospective arm, the evaluation of disease control and~     toxicity results in approximately 1300 patients treated from January 2009, when the~     hypofractionated radiotherapy has been adopted as a standard after breast conserving~     radiotherapy, up to 2016.~   "
37394|NCT03077178|"~     In order to describe functional impact of surgery in elderly patients treated for lower-limb~     soft-tissue sarcoma, the investigators set up this project which aims to identify prognostic~     factors among geriatric and functional assessment.~   "
37353|NCT03077711|"~     Several methods are available for use in the prevention of recurrent urinary tract infections~     (UTIs) over the past few decades. These methods include suppressive antibiotics, estrogen~     cream, methenamine hippurate, d-mannose, cranberry, probiotics, and vitamin C. Of these, the~     majority of the literature is in favor of use of suppressive antibiotics for preventing UTIs.~     However, this data is now about 10 years old. Increasing use of antibiotics over the years~     has lead to increased resistance of bacteria. In addition, long-term antibiotic use has~     several adverse effects, some life-threatening. There is recent literature evaluating the use~     of several of the alternatives to suppressive antibiotics with mixed results. A comparative~     study of the efficacy of methenamine hippurate to suppressive antibiotics is lacking in the~     current literature. Several early partly-randomized trials done with methenamine hippurate~     have shown promising results, but are only as recent as 1987. The primary objective of this~     prospective, randomized study is to determine whether there is a significant difference in~     the prevention of recurrent UTIs when given either methenamine hippurate or daily suppressive~     antibiotics. The secondary objective of this study is to determine how well patients are able~     to tolerate each of these medications and what adverse effects are observed in a given 1 year~     time period. The long-term goals of this study are to find an alternative to using~     suppressive antibiotics, potentially with a lower adverse effect profile and less of the~     dangers of long term antibiotic use. Finding an alternative to suppressive antibiotics would~     also tackle the issue of antibiotic resistance.~   "
37354|NCT03077698|"~     This is an open-label, multi-center, single-arm, two-period Phase 2 study. The study will~     investigate the efficacy of Sodium Cridanimod in conjunction with progestin therapy in a~     population of subjects with recurrent or persistent endometrial cancer, who have failed~     progestin monotherapy or who have been identified as PrR negative. All patients must have~     endometrial cancer PrR status determined from an archival sample at Screening. The PrR status~     (positive or negative) will be determined by central laboratory by IHC testing.~      There are two treatment periods and a follow-up period within the study.~   "
37355|NCT03077685|"~     Open-label, dose-escalating, Phase IIa trial of NanoPac® to treat subjects with locally~     advanced pancreatic adenocarcinoma via direct intratumoral injection.~   "
37356|NCT03077672|"~     Mitochondria are organelles (a specialized subunit of a cell) responsible for providing cells~     with energy. For reasons not yet understood, mitochondria will release their DNA into blood~     in response to cellular injury or cell death.~      With a simple blood draw, investigators can measure the amount of mitochondrial DNA in a~     patient's blood.~      The investigators' hypothesis, is that mitochondrial DNA can be used as a surrogate marker of~     cellular injury to predict patient outcomes. The investigators intend to test their~     hypothesis by measuring mitochondrial DNA in adult patients presenting to the Emergency~     Department with sepsis (a life-threatening condition due to an infection) and observing their~     hospital course.~   "
37357|NCT03077659|"~     Open-label, dose rising, Phase IIa trial of intratumorally-injected NanoPac® 6, 10, or 15~     mg/mL in subjects with prostate cancer scheduled for prostatectomy.~   "
37358|NCT03077646|"~     There is currently no available data regarding using the inpatient setting as an opportunity~     to talk to parents/guardians about firearm safety. The investigators will be doing a~     pre-/post-intervention study to investigate the effect of an intervention (a 5.5 minute Be~     SMART video and written materials developed by the organization Everytown for Gun Safety), on~     parental/legal guardian knowledge, attitudes and practices regarding firearm safety. While~     the American Academy of Pediatrics recommends the safest home for children is one without~     guns, the reality is that there are families with guns in the home. This non-political video~     focuses on ways to keep children safe from firearms.~      The investigators will also investigate any additional effect of physician-delivered~     counseling on parental/guardian knowledge, attitudes and practices regarding gun safety as~     compared to receiving the information solely via video and written materials.~      Participants will be randomized to 1 of 3 groups (intervention, intervention + MD discussion~     and control group). Outcomes will be assessed immediately post intervention and in a 30-day~     follow up phone call.~   "
37359|NCT03077633|"~     A prospective randomized control trial that will compare cervical cerclage plus vaginal~     progesterone to vaginal progesterone along in twin pregnancies complicate by a short cervix~     (</= 15.0mm) between 16w0d to 25w6d.~   "
37360|NCT03077620|"~     The purpose of this study is to change the concentration of amyloid-beta in human~     cerebrospinal fluid (CSF) by modification of sleep efficiency.~   "
37361|NCT03077607|"~     This is a study in patients with advanced solid tumors for the investigation of P-gp~     inhibition and induction on the PK of talazoparib.~   "
37362|NCT03077594|"~     To prospectively assess the functional aspects of the the esophageal squamous epithelial~     barrier and correlate this with tissue inflammation and intercellular space dilation in~     patients who have successfully completed endoscopic radiofrequency ablation versus balloon~     cryotherapy for Barrett's Esophagus related metaplasia.~   "
37363|NCT03077581|"~     This study was conducted to demonstrate post-abdominoplasty analgesic duration consequent to~     three different surgically infiltrated LA techniques; bilateral TAPB, bilateral RSB and~     subcutaneous infiltration using the same volume of 0.25% bupivacaine (40 ml). Pain score,~     total analgesic rescue requests and the total amount of systemic rescue analgesia used in the~     first postoperative day in addition to any detected postoperative complications were also~     recorded.~   "
37395|NCT03077165|"~     Dose-response relationship study of S42909 on leg ulcer healing after oral repeated~     administration in patients with active venous leg ulcer.~   "
37396|NCT03077152|"~     Up to 90% of consulting Acute Exacerbation (AE) of COPD patients are prescribed an~     antibiotic(1).~      Rates of inappropriate antibiotic prescription percentage can be as high as 65%(2).~      Excessive use of antibiotics is correlated with higher prevalence of antimicrobial~     resistance(3). There are insufficient data regarding the overprescribing antibiotics in~     AECOPD in our country.Therefore the investigators aimed to investigate the patients factors~     that are associated with the prescription of antibiotic for inappropriate indication in~     AECOPD.This is an observational cross sectional study.Population: AECOPD patients with~     AB(antibiotic) prescription Exposure: Presence of patient factors, Comparison: Absence of~     Patient factors, Outcome: Prescription of antibiotic for inappropriate indication.~      Sampling:~      Consecutive patients presenting to pharmacy between Monday and Friday. Date between January 1~     2017 to January 1 30 2019. Primary Outcome:Prescription of antibiotic for inappropriate~     indication according to Anthonisen criteria for AECOPD Anthonisen criteria:-Worsening of~     dyspnea~        -  Increased sputum volume~        -  Increased sputum purulent 3/3 →Type 1 or severe AE 2/3 →Type 2 or moderate AE 1/3 →Type~          3 or mild AE AB indicated/useful in Type 1 or severe AE, and Type 2 or moderate AE if~          sputum is purulent The data will be obtained from the database.~      Exposure:~      Patient factors that lead to inappropriate antibiotic prescription (will be considered~     together in analysis due to confounding) FEV1% Age Current smoker Comorbidities (Charlson~     comorbidity index) having Frequent exacerbations (≥2 past year) Use of oral steroids~     Polypharmacy Quality control:Detailed MOP will be developed, A manual for protocol will be~     written and used to inform the pharmacist,Pharmacist will be trained; to speak to~     participants in a neutral manner for written informed consent for the security ID(identity)~     data of the patients,This study will not affect the time period of the participants to access~     his/her drug. The pharmacy will use the questionnaire within the time period planned. A~     checklist for exclusion criteria will be developed. A plan for missing data will be~     developed.~      Null hypothesis:~      Patient factors are not associated with the prescription of antibiotics for inappropriate~     indications in patients with AECOPD~      Alternative hypothesis:~      Patient factors are associated with the prescription of antibiotics for inappropriate~     indications in patients with AECOPD Analysis The data will be analysed using SPSS version~     22.0 The investigators will compare exposure variables between inappropriate and appropriate~     prescription groups Continuous variables - t test or Mann Whitney Binary- chi square test The~     investigators will use logistic regression to measure the associations between patient~     factors and the outcome of prescription of antibiotics for inappropriate indication Sample~     size and power Sample size to estimate CI of 15% around 25 to 50% prevalence of inappropriate~     prescription with p=0.05 and Power 80% Expected proportion0,25 128 0,50 171 Sample size and~     power For logistic regression - estimate 30% prevalence (n=143), or about 42 events . The~     investigators also need 5-10 events for each variable in the model, so this provides~     sufficient power for 4 to 8 factors.~      Limitations This study will just determine an association not causality~      The investigators won't be able to determine if the participant is truthful to the pharmacist~      The history of participants will be assessed from hospitals e-database - potential for~     missing data.~      The Anthonisen criteria for identifying inappropriate AB for AECOPD are still debatable The~     investigators can not modify many of the patient factors, but may be able to identify~     patients at higher risk of inappropriate antibiotics Ethics The project will be submitted to~     the ethical committee of Dr. Suat Seren Chest Disease Hospital Oral and written informed~     consent will be obtained from all subjects The study will be conducted in accordance with~     Good Clinical Practice Guideline Relevance This study will be the first one to evaluate an~     association between patient factors and prescription of antibiotic for inappropriate~     indication in an outpatient clinic of patients with AECOPD in Turkey.~      Subsequent studies should evaluate physician factors prescription of antibiotic for~     inappropriate indication.~   "
37397|NCT03077139|"~     This study is being conducted to determine whether patients with advanced pulmonary~     hypertension when treated with cardiac resynchronization therapy improve hemodynamically~     and/or receive clinical benefit.~   "
37398|NCT03077126|"~     The main purpose of this study is to determine the accuracy and feasibility (possibility) of~     Aixplorer® ShearWave Elastography (SWE™) Ultrasound System (made by SuperSonic Imagine, Inc.)~     for detecting prostate cancer in men undergoing radical prostatectomy.~   "
37399|NCT03077113|"~     This is a prospective study of ventilation image comparison for lung functional information~     incorporation in thoracic cancer treatment planning.~   "
37364|NCT03077568|"~     A randomized controlled trial is needed to strengthen the evidence in the area of web-based~     self-management programs for stress-reduction.~      Aim The aim for the study is to compare the effects of the web-application that supports~     behavior change in stress-management to a waiting list group in persons with perceived~     stress.~      Method This study will have the design of a randomized controlled trial (RCT). The CONSORT~     guidelines will be used for reporting the study.~      Sample: Different sectors in the region will be included. Three different high-schools in~     Västerås City, social services authority in Västerås municipality, a large private company in~     the region, three different clinics within the county council and the municipality of Köping~     have signed the attestation of participation.~      Intervention: The intervention is the program for web-based stress self-management My Stress~     Control.~      Procedure: After informed consent the participants will, during approximately 2-4 months by~     their own go through the web-based program for stress self-management. The waiting-list group~     will also get access to My Stress Control after post-measurements.~      Data-analysis: Descriptive statistics will be used for demographic data. Missing data will be~     replaced as recommended for the different measurements included, commonly by using the mean~     for responded items within the sub scale. Inferential analyses will be conducted by using~     multivariate statistical analysis.~      Drop-out analysis will be conducted by comparing pre-interventions measures for those who~     completed the program with those who did not.~   "
37365|NCT03077555|"~     Quick starting combined oral contraception containing estradiol hemihydrate/nomegestrol~     acetate is effective to inhibit ovulation in healthy reproductive age women and~     non-inferiority to combined oral contraception containing ethinyl estradiol/gestodene.~   "
37366|NCT03077542|"~     Background:~      Peripheral blood stem cell transplantation procedures are used for people with sickle cell~     disease. Researchers want to improve the success and reduce the complications for these~     procedures. This might allow more people to have a transplant.~      Objective:~      To see if a new transplant regime is effective, safe and well tolerated in people with sickle~     cell disease.~      Eligibility:~      Adults at least 18 years old with sickle cell disease and certain complications.~      A relative who is a half tissue match.~      Design:~      Participants will be screened with medical history, physical exam, and blood tests.~     Recipients will also have:~        -  Heart, lung, and mental health tests~        -  Chest x-rays~        -  Bone marrow taken from the pelvic bone~        -  Eyes and teeth checked~      Recipients will have a large central line inserted into a vein for up to 6 months.~      Donors will have their veins tested and have an IV inserted for 1 day or on rare occasions 2~     days.~      Donors will get a drug to activate bone marrow. It will be injected for about 6 days.~      Donors will have at least 1 five-hour procedure where bone marrow stem cells will be~     collected. Blood will be taken from a vein in one arm or in rare cases from a groin vein and~     put through a machine. Some blood will be saved and the rest will be returned. Stem cells~     will be taken from the saved blood in a lab and frozen until ready to give to the recipient.~      Recipients will have:~        -  Stems cells collected and frozen~        -  Hygiene lessons~        -  Bone density scans~        -  Low-dose radiation~        -  Drugs for their immune system~        -  Donor cells infused through their central line~        -  Transfusions~      After about 30 days, recipients will leave the hospital. They must stay near NIH for 3 months~     after the transplant and have frequent visits. After returning home, they will have 8 visits~     over 5 years, then be contacted yearly.~   "
37367|NCT03077529|"~     The population is aging worldwide, concomitant frailty is increased in older age groups.~     Frailty has a strong impact on outcomes of multi-morbidity and daily living, thereby~     negatively influencing quality of life and health care costs. Prevention or delay of onset of~     frailty associated with aging is needed. Dietary intake of galacto-oligosaccharides (GOS) may~     have beneficial effects on microbiota composition and health outcome parameters. As~     microbiota composition and function may be altered in elderly compared to younger adults, it~     will investigated whether the effects of GOS on selected parameters of microbiota and gut~     health differ between elderly versus younger adults. The primary objective of this study is~     to compare the effects of four weeks GOS supplementation on intestinal microbiota composition~     and activity in elderly versus younger adults. Further, this study has four secondary~     objectives. The study conforms to a randomized double-blind placebo-controlled cross-over~     design per age-group. Study populations are human volunteers (male and female), healthy young~     adults of 25-50 years and prefail older adults of 70-85 years old, BMI 20-30 kg/m2. One~     intervention period subjects will receive 7.2 grams of Vivinal® GOS Powder three times daily~     for four weeks. The other intervention period subjects will receive isocaloric placebo~     supplements (5.7 grams maltodextrin) three times daily for four weeks. At the start and end~     of each intervention period, several measurements will take place. There will be a washout~     period of four to five weeks between intervention periods. The main study parameter is the~     change in microbial composition and activity induced by GOS intervention, in younger adults~     and elderly.~   "
37368|NCT03077516|"~     The purpose of this study is to evaluate clinical and patient-reported outcomes at 10 years~     following surgery for a cohort of Mobi-C subjects treated on the IDE/Post Approval studies~   "
37369|NCT03077503|"~     To compare the effect between dexmedetomidine and fentanyl for controlling the hemodynamic~     response to skull pins application~   "
37370|NCT03077490|"~     Comparison of single versus multicenter outcomes for pelvic organ prolapse repair using a~     mesh-capturing device (The Uphold™ Vaginal Support System for apical and vaginal wall~     prolapse - Boston Scientific). 1-2 years follow up study comprison of 112 vs 207 patients.~   "
37371|NCT03077477|"~     This is a Phase 1 study, which will assess the safety, PK, and pharmacodynamics (PD) of~     orally-administered AMXT 1501 dicaprate in normal healthy male volunteers.~      The study is comprised of a total of 8 cohorts; 4 single ascending dose (SAD) cohorts, 1 Food~     Effect (FE) Crossover cohort, and 3 multiple ascending dose (MAD) cohorts. Tablets will be~     administered after an overnight fast (10 hours) with at least 250 mL water. No food will be~     administered (exception for fed subjects, see below) for one hour thereafter.~      Each cohort will have a total 6 subjects: SAD and MAD (2 subjects receiving placebo and 4~     subjects receiving active AMXT 1501 dicaprate); and FE crossover (6 subjects receiving active~     AMXT 1501 dicaprate).~   "
37372|NCT03077464|"~     Healthful eating is a core component of a healthy lifestyle that is associated with lower~     risk of obesity and chronic disease. Although adolescent health promotion programs have been~     extensively evaluated and applied in English-speaking Western developed nations, there is~     very little published literature in the Russian context. Our study seeks to determine the~     relative effectiveness of a healthy lifestyle intervention consisting of nutrition education~     at a Russian camp. Investigators will determine the impact of behaviorally focused nutrition~     education on nutrition knowledge, food choice, attitude, and self-efficacy for healthful~     eating, compared to standard nutrition education.~   "
37373|NCT03077451|"~     This pilot phase II trial studies how well nelfinavir mesylate works in treating patients~     with kaposi sarcoma. Nelfinavir mesylate may stop the growth of tumor cells by blocking some~     of the enzymes needed for cell growth.~   "
37374|NCT03077438|"~     The aim of this trial is to evaluate the immunogenicity and describe the safety of MenACYW~     conjugate vaccine compared to MENVEO® in healthy children 2 to 9 years of age in the United~     States.~      Primary objective:~      - To demonstrate the non-inferiority of the vaccine seroresponse to meningococcal serogroups~     A, C, Y, and W following the administration of a single dose of MenACYW conjugate vaccine~     compared to that observed following the administration of a single dose of MENVEO® in~     children aged 2 to 9 years.~      Secondary objectives:~        -  To compare the hSBA antibody geometric mean titers (GMTs) of meningococcal serogroups A,~          C, Y, and W following the administration of MenACYW conjugate vaccine to those observed~          following the administration of MENVEO® in children 2 to 9 years of age~        -  To evaluate the hSBA antibody GMTs of meningococcal serogroups A, C, Y, and W following~          the administration of MenACYW conjugate vaccine and those observed following the~          administration of MENVEO® in children 2 to 5 years of age, and in children 6 to 9 years~          of age, respectively.~        -  To evaluate the hSBA vaccine seroresponse to meningococcal serogroups A, C, Y, and W~          before and 30 days (+14 days) post-vaccination in children 2 to 5 years of age, and in~          children 6 to 9 years of age, respectively.~      Observational objective:~      - To describe the safety profile of MenACYW conjugate vaccine and that of the licensed~     MENVEO®.~   "
37375|NCT03077425|"~     The CHALO (Child Health Action to Lower Oral Health and Obesity) -- from an Urdu word~     meaning Let's go!—is a multi-level strategy to reduce pediatric obesity and dental caries~     risk in South Asian (SA) children. Obesity and caries are the two most prominent health~     disparities of early childhood. Both caries and obesity: a) disproportionately impact~     low-income children of color, b) share common risk behaviors, i.e., feeding practices, and c)~     can most effectively be reduced or prevented prevention in infancy and early childhood. SA~     immigrant children are at high risk for both. CHALO includes both a randomized controlled~     trial (RCT) aimed at reducing risk behavior, and a Knowledge Translation project to raise~     awareness in SA lay and professional communities regarding child health risks.~   "
37376|NCT03077412|"~     The primary objective of this study is to evaluate the efficacy of filgotinib as compared to~     placebo in establishing combined fistula response at Week 24. Participants will have the~     option to enter a separate long-term extension study if they meet eligibility requirements.~   "
37377|NCT03077399|"~     Development and clinical validation of SCALA, a new rating scale for lateropulsion after~     stroke. A monocentric controlled study including 60 patients post-stroke and 40 patients~     without stroke and/or healthy volunteers..~      In order to analyze the SCALA's content validity, a Delphi-type consensus process will be~     applied prior to clinical validation. The Delphi process, including 20 international experts,~     will give rise to the version of the scale to be tested clinically.~   "
37378|NCT03077386|"~     In Canada, the prevalence of chronic disease is increasing and patients presenting with~     multiple conditions (i.e., multimorbidity) are becoming the norm in primary care. Complex~     treatment regimens such as administration of medications (including insulin), clinical~     monitoring and screening for complications, adherence to dietary and lifestyle changes, and~     decisions about when to seek medical care are challenging. To help people with complex health~     conditions optimize their care and outcomes, community health worker programs have begun to~     be used across the United States and Canada. Existing community health worker programs share~     a common goal of helping patients to overcome modifiable barriers to care to achieve optimal~     outcomes.~      While community health workers may work within a primary health care team, the primary role~     of the community health worker is not clinically oriented, and may be fulfilled by~     laypersons. Depending on the targeted barriers, specific tasks may include one or more of:~     disease education, health system education, assistance with insurance coverage, aid in care~     coordination, and referral to community resources, among others. Herein, the investigators~     aim to evaluate the effectiveness of a community health worker intervention on improving~     acute care utilization among patients with complex chronic disease seen in primary care.~   "
37379|NCT03077373|"~     This study examines the efficacy of individualized counseling letters to reduce systolic~     blood pressure level of ≥ 130 mmHg in individuals aged between 40 and 65 years. The~     computer-generated counseling letter intervention aimed to increase moderate-to-vigorous~     physical activity, to reduce sedentary time, and to achieve smoking abstinence.~   "
37380|NCT03077360|"~     The rationale for the proposed research is that elucidating changes in localized~     diacylglycerol (DAG) and sphingolipid species that predict insulin sensitivity will reveal~     specific localized lipids to target in therapeutics for type 2 diabetes. To attain the~     overall objective, the investigators propose three specific aims: 1. Identify the influence~     of sarcolemmal DAG and sphingolipids on cell signaling and insulin sensitivity before and~     after insulin sensitizing lifestyle interventions. Strong preliminary data shape the~     hypothesis that sarcolemmal 1,2-disaturated DAG and C18:0 ceramide species will decrease~     after insulin sensitizing lifestyle interventions, leading to less Protein kinase C (PKC) and~     Protein phosphatase 2A (PP2A) activation, and enhanced insulin signaling. Skeletal muscle DAG~     and sphingolipid isomers, species, localization, and de novo synthesis will be measured~     before and after diet-induced weight loss or exercise training interventions in obese men and~     women. Insulin sensitivity will be measured using insulin clamps, and muscle lipids using~     Liquid Chromatography Mass Spectrometry (LC/MS). 2. Determine the impact of mitochondrial/ER~     (endoplasmic reticulum) DAG and sphingolipids on mitochondrial function and ER stress in~     vivo, before and after insulin sensitizing lifestyle interventions. The investigators~     hypothesize, again based on preliminary data, that mitochondrial/ER sphingolipids will~     decrease, yet DAG will increase after insulin sensitizing lifestyle interventions, and each~     will associate with increased insulin sensitivity. Changes in sphingolipids will relate to~     increased mitochondrial function, less ER stress, reactive oxygen species (ROS), and~     acyl-carnitine formation, while changes in DAG will relate to increased mitochondrial content~     and dynamics. 3. Identify the effect of exogenous DAG and sphingolipids on mitochondrial~     function in vitro, before and after insulin sensitizing lifestyle interventions. The working~     hypothesis is that DAG and sphingolipids will reduce mitochondrial respiration and increase~     ROS and acyl-carnitine content, but will be attenuated after endurance exercise training. The~     proposed research is innovative because it represents a substantive departure from the status~     quo by addressing cellular compartmentalization of bioactive lipids. The investigators~     contribution will be significant by identifying key species and locations of DAG and~     sphingolipids promoting insulin resistance, as well as mechanisms explaining accumulation~     that could be modified by insulin sensitizing therapeutic interventions.~   "
37400|NCT03077100|"~     To aim of this study is to identify the pathogens and their distribution in the NICU and to~     determine whether empirical antibiotics are suitable for the treatment of sepsis in the unit.~   "
37401|NCT03077087|"~     This is a prospective, descriptive, pilot case series involving patients with significant~     burns who are candidates for reconstruction with Integra®. Subjects would have a small area~     of the wound would, at the time of excision, have the smallest sheet of thin Integra® (125~     cm2) placed and be immediately autografted with a 3:1 meshed split-thickness skin graft. Of~     note, 125 cm2 represents approximately 0.7% of an average sized patient's total body surface~     area, so for even the smallest burns in our proposed trial, this area would represent a small~     portion of the patient's area of injury. The remaining injury areas would be covered with~     standard-thickness Integra® only.~   "
37381|NCT03077347|"~     The purpose of this study is to better understand the neural correlates of cognitive control~     (CC) deficits in schizophrenia and determine how these mechanisms can be modulated by~     transcranial direct current stimulation (tDCS). CC is a critical neurocognitive process that~     is required for flexible, directed thought and action based on goals and intentions.~     Identifying and developing paradigms to improve CC is therefore a mental health priority.~     Current theories of CC postulate that recruitment of the dorsolateral prefrontal cortex~     (DLPFC) is essential for this process by maintaining high-level information that it can then~     use to orchestrate patterns of activation in other brain networks to support optimal~     performance. tDCS is a safe, noninvasive method of modulating regional brain excitability via~     brief (15-20 m) application of a weak (1-2 mA) current. The goal of the proposed experiments~     is to combine tDCS with functional magnetic resonance imaging (fMRI) to test the hypotheses~     that 1) acute tDCS over the DLPFC can improve performance during a CC task (the dot pattern~     expectancy (DPX) variant of the AX-Continuous Performance Task) in schizophrenia patients and~     healthy control subjects, and 2) acute tDCS over the DLPFC can increase recruitment of the~     DLPFC during the DPX. Effects of tDCS on brain functional connectivity (during CC as well as~     during the resting state) will also be examined, as well as effects on an episodic memory~     task. The current study will be the first to use functional magnetic resonance imaging (fMRI)~     to examine the effects of tDCS on the neuronal mechanisms of CC in schizophrenia, and has~     potentially important implications for therapeutic development for this treatment refractory~     yet disabling aspect of the illness.~   "
37382|NCT03077334|"~     The 18F-FDG-PET scan is currently being used for cancer diagnosis, staging, identifying~     hidden metastasis, and assessment of treatment responses in clinical oncology. Although there~     are important studies suggesting potential associations between PET-based parameters and~     oncologic outcomes, the calculation and official documentation of individual PET-based~     parameters might not be routine in clinical practice because these processes usually require~     time- and labor-consuming processes for the radiologists. In this study, the investigators~     prospectively determined clinical 18F-FDG-PET type according to degree of FDG-uptake in~     pancreatic cancer and compare oncologic outcomes between the types.~   "
37383|NCT03077321|"~     This is a randomized clinical trial of the impact of incorporating a peer mentor into a~     primary care based group parenting program on increasing program participation by parents and~     improving program outcomes.~   "
37384|NCT03077308|"~     The overall purpose of this project is to advance understanding of the neurophysiological~     features of Rett syndrome (RTT), MECP2 Duplication (MECP2 Dup) and RTT-related disorders~     (CDKL5, FOXG1) to gain insight into disease pathogenesis, with an emphasis on identifying~     biomarkers of disease evolution and severity. This specific study is intertwined to the core~     study Natural History of Rett Syndrome and Related Disorders (RTT5211), which characterizes~     range of clinical involvement and genotype-phenotype correlations and will provide~     phenotypical data for determining the clinical relevance of the neurophysiologic parameters;~     study subjects here are co- and primarily enrolled in RTT5211. The proposed studies will~     serve as basis of future translational investigations, including further refinement of~     biomarkers, development of outcome measures, and clinical trials per se.~   "
37385|NCT03077295|"~     This weight loss study will investigate the impact of diet composition and meal size (large~     breakfast meals and smaller evening meals) on body weight, energy balance and eating~     behaviour, by altering calorie (meal) distribution.~   "
37386|NCT03077282|"~     To investigate the safety of Prasaprohyai 95% ethanolic extract at doses of 100 mg and 200 mg~     for for 6 weeks. (Clinical Trial phase I)~   "
37387|NCT03077269|"~     The purpose of this study is to understand what happens to platelets and blood clotting~     factors in burn patients over time. This study will also examine the role of microparticles~     (MPs), nanoparticles (NPs), and micro RNA in burns. The investigators will be looking at~     small particles of cells that are released into the blood. These particles have been found to~     be important in a variety of different diseases. The investigators believe that MPs, NPs, and~     micro RNA may play a role in development of inflammation, and infections in burn patients.~     Thus, hopefully, this study will help understand how to minimize transfusions and bleeding in~     burn patients as well as how to reduce inflammation and infections in burn patients.~   "
37388|NCT03077256|"~     This prospective registry was designed as an observational study to ascertain how~     commercially available Burst Products are being used by foot and ankle surgeons performing~     procedures which involve bone grafting, as well as determining relevant patient outcomes.~   "
37389|NCT03077243|"~     The primary objective of this study is to evaluate whether genomic based risk-stratification~     can be used in deciding whether to de-intensify in patients with Human Papillomavirus~     (HPV)-associated Oropharyngeal Squamous Cell Carcinoma (OPSCC) with > 10 pack years smoking~     history. Hypothesis: Patients with HPV-associated OPSCC, > 10 pack years smoking history, and~     non-mutated p53 will have similar 2 year progression-free survival (PFS) as patients with <~     10 pack years smoking history.~   "
37390|NCT03077230|"~     The primary objective of this study is to assess the effect of the decision aid on measures~     of decision-making such as knowledge, screening attitudes, decisional conflict, and screening~     intent.~   "
37391|NCT03077217|"~     Several studies have been showed that rifaximin can improve cognitive functions, driving~     simulator performance and health-related quality of life in patients with minimal hepatic~     encephalopathy. The aim of this prospective randomized open controlled study was to evaluate~     the efficacy and safety of rifaximin at different doses for the treatment of covert hepatic~     encephalopathy.~   "
37392|NCT03077204|"~     The goal of this study is to investigate the efficacy of BIO4 bone matrix in patients~     undergoing 1 or 2-level Anterior Cervical Discectomy and Fusion (ACDF) spine surgery.~     Specifically, the study aims to collect the data for ACDF model utilizing BIO4 with Bio AVS~     Cervical Allograft (with graft window).~   "
37416|NCT03076892|"~     This study aims to compare the efficacy and tolerance of a new photodynamic therapy device~     (PHOS-ISTOS) with the conventional PDT device (Aktilite®) for the treatment of actinic~     keratosis of the scalp~   "
37417|NCT03076879|"~     In order to evaluate the effectiveness of nursing interventions aimed at the early detection~     of cervical cancer, health belief and participation in the screening of women aged 40-55 at~     risk for the purpose of cervical cancer, One-way blind pre-test and post-test randomized~     controlled trial.~   "
37402|NCT03077074|"~     The aim is to profile and elucidate the hormonal and neurological system interaction to food~     related behavior. The stimulus used will include visual and taste (gustatory) stimuli. The~     study will profile induced correlations of metabolic parameters, gut hormones and brain~     region (ROI - regions of interest) activation and interaction. In this study we will use fMRI~     (functional MRI) to compare brain responses in obese, normal-weight and reduced weight~     subjects. The food stimuli will be blocked into specific categories to allow for~     investigation of different responses to alternating energy density foods. The response will~     be tested prior to and following a brief low carbohydrate dietary regimen.~   "
37403|NCT03077061|"~     The project will evaluate the potential benefit of the use of bone replacement graft as an~     adjunct to surgical therapy of peri-implantitis. The project will be conducted as a two-armed~     randomized controlled clinical trial of 5-year duration in 7 clinical centers. 140~     systemically healthy patients diagnosed with peri-implantitis will randomly assigned to be~     treated with or without bone replacement graft. Outcome measures include assessments of~     inflammation, probing depth, recession, radiological parameters and PROMs.~   "
37404|NCT03077048|"~     Supplementation of ketoanalogues of essential amino acids improves the protein quality of~     protein restricted diets without burdening the kidneys. The ketoanalogues are transaminated~     by aminotransferases to the corresponding amino acids by incorporating nitrogen from amino~     groups derived from endogenous amino acid degradation. Therefore, less nitrogen needs to be~     excreted and the kidney's workload is reduced.~      The purpose of the trial is to investigate the impact of Ketosteril® supplementation on A)~     nutritional safety and tolerance of a low protein diet (LPD) (0.6 g protein/kg bodyweight~     (BW)/day)and B) net protein synthesis in pre-dialysis CKD patients.~      Changes of urea in serum and urine will be assessed under controlled metabolic balance~     conditions in non-dialysed CKD patients consuming a LPD supplemented with Ketosteril® at 1~     tablet/5 kg body weight/day compared to the same, isonitrogenous and isocaloric diet without~     Ketosteril®.~      Changes in protein synthesis and degradation at the defined protein intake with or without~     Ketosteril® supplementation will be investigated - based on nitrogen balance, normalized~     protein catabolic rates as well as blood levels of defined proteins as surrogate markers for~     net protein synthesis and anabolic signaling.~   "
37405|NCT03077035|"~     The study was to monitor effectiveness of glass ionomer sealant and resin-based sealant in~     ICDAS, and to evaluat the correlation between ICDAS and DIAGNOdent over 24 months. Over 200~     8-year-old children with at least 2 permanent molar with the International Caries Detection~     and Assessment System (ICDAS) scores 0-4 were placed glass ionomer sealant and resin-based~     sealant split-mouthed randomly, and examined with ICDAS and DIAGNOdent before sealents~     placement and 6, 12 and 24 months after.~   "
37406|NCT03077022|"~     The treatment of femoroacetabular impingement has evolved over the last several years. As the~     number of arthroscopic hip operations has risen over the last few years, so has the level~     controversy in regards to the appropriate initial management. There have been many recent~     advances in clinical diagnosis, advanced imaging techniques, improved indications for surgery~     and improved arthroscopic techniques which have led to improved clinical outcomes, but the~     effectiveness of physical therapy remains unknown.~   "
37407|NCT03077009|"~     This is a study to assess the benefit of sodium hyaluronate (Ostenil) injection for plantaris~     friction syndrome (PFS) associated with midportion Achilles tendinopathy. Functional outcome~     scores will be recorded prior to treatment and at regular intervals up to 2 years. Changes in~     tendon structure will be assessed using ultrasonographic tissue characterisation (UTC). UTC~     will be performed prior to treatment and also at regular intervals up to 6 months following~     injection.~   "
37408|NCT03076996|"~     This study will examine the feasibility and acceptability of an intervention designed to~     improve retention in HIV care services and improve anti-retroviral therapy (ART) adherence~     among adolescents ages 15-19 years living with HIV enrolled in ART services.~   "
37409|NCT03076983|"~     The results of this study will help to define the capability and reliability of PulmoVista~     500 to detect changes in both global and regional ventilation.~   "
37410|NCT03076970|"~     This is a randomized, double-blind, three-period, cross-over study to investigate the effect~     of sumatriptan (Imitrex) 100 mg on the pharmacodynamics and pharmacokinetics of lasmiditan~     200 mg.~   "
37411|NCT03076957|"~     The purpose of this open-label, dose-escalation phase I trial is to evaluate the safety,~     tolerability and pharmacokinetic profiles and to assess the efficacy of CKD-516 Tablet in~     Combination with Irinotecan inj. in Patients with Previously Treated Advanced Colorectal~     Cancer~   "
37412|NCT03076944|"~     The aim of this study is through a double blind randomized clinical trial, evaluate the~     effectiveness of different clinical protocols in the reduction of dentin hypersensitivity.~     The desensitization approach (single agent or associated agents) and the long-term~     effectiveness (baseline, 1 week, 2 weeks, 4 weeks, 12 weeks and 24 weeks) will be evaluated.~     Data will be collected, tabulated and submitted to statistical analysis.~   "
37413|NCT03076931|"~     Objective:~      The purpose of this proposal is to use High Speed Videoendoscopy (HSV) to develop and test an~     imaging biomarker to support diagnosis and predict vibratory outcome after airway~     reconstruction. Our protocol will involve eliciting and recording the following five~     behaviors: (1) hard throat clear; (2) cough; (3) laugh; (4) short multiple phonations; and~     (5) sustained phonation. These HSV recordings will be used to develop the biomarkers.~      Study Design: A prospective cohort study of 60 patients, 36 who will undergo airway~     reconstruction and 24 age matched controls.~      Setting: Center for Pediatric Voice Disorders, Department of Otolaryngology, Cincinnati~     Children's Hospital Medical Center~      Methods: Subjects will undergo a full voice evaluation, including an HSV evaluation protocol,~     at the main study site prior to airway reconstruction, 6 months post and 1 year post surgery.~     Voice evaluation will include aerodynamic, acoustic, and perceptual voice assessments, a~     pediatric voice handicap index questionnaire, videostroboscopy, and HSV. The airway~     evaluation will include airway sizing and calibration.~   "
37414|NCT03076918|"~     This study compares the efficacy and tolerance of a new device (FLEXITHERALIGHT) for~     photodynamic therapy in the treatment of keratosis actinic in comparison of classical PDT~     with Aktilite®.~   "
37415|NCT03076905|"~     Open label evaluation of a single intravenous dose of F901318 to healthy male and female~     subjects with pharmacokinetic and safety and tolerability evaluation.~   "
37420|NCT03076840|"~     The hamstring muscle is an important muscle that affect the performance of almost all~     activities of daily living. Since this muscle is a large muscle that pass across two major~     joints (the hip and knee joint), it is more susceptible to become tight and to lose its~     extensibility. On the other hand, there is no agreement on a standard protocol for the~     treatment of hamstring tightness. Kinesio tape is one of the options for treatment of~     hamstring muscle, it is a safe, passive and non-painful intervention, and if proven to be~     effective it will help individuals especially those with poor compliance and poor tolerance~     to painful stretching exercises. The aim of the present study is to investigate the acute~     effectiveness of Kinesio taping on hamstring muscles extensibility. 96 students with~     hamstring tightness will be recruited from the University of Dammam to participate in this~     prospective experimental study. All participants will be assigned randomly to either a~     Kinesio tape group, Sham tape group and control group. Outcome measures will be the hamstring~     length measurement by using active knee extension test and strength measurement for hamstring~     and quadriceps muscles by using a handheld dynamometer. Outcome measurement will be taken at~     baseline and 15 minutes after the intervention.~   "
37421|NCT03076827|"~     Cortisol is a hormone that increases after trauma or surgery and has circadian rhythm. It has~     a form that is increased in the morning and decreased in the evening. The investigators~     expected to be influenced by circadian rhythm according to the time of operation, and~     compared morning and afternoon surgery.~   "
37422|NCT03076801|"~     This pilot randomized control trial will examine the role of choral singing on psychosocial~     stress and cardiovascular outcomes in patients with ischemic heart disease (IHD). The~     hypothesis is that choral singing will improve psychosocial stress in comparison to the~     control group and this may have an impact on rates of hospitalization, death, myocardial~     infarction and stroke in these patients.~   "
37423|NCT03076788|"~     The uncertainty concerning the onset and the extent of cardiac remodeling in response to~     intensive training hinders medical evaluation by physician. A better knowledge of the~     physiology of cardiac adaptation to training will enable physicians to correctly determine~     whether observed patterns of cardiac remodeling are physiological or pathological. This~     prospective study proposes to assess in a trained-athlete population the cardiac remodeling~     in response to intensive exercise training. This study is observational, we do not interfere~     with athlete's training.~   "
37424|NCT03076775|"~     Annually in the U.S 300,000 neonates are born late preterm, defined as 34 weeks 0 days - 36~     weeks 6 days. The Antenatal Late Preterm Steroids (ALPS) Trial demonstrated that maternal~     treatment with betamethasone in the late preterm period significantly reduces neonatal~     respiratory complications, but also increases neonatal hypoglycemia, compared to placebo.~      This research study will attempt to answer the following primary question: Does a management~     protocol aimed at maintaining maternal euglycemia after ALPS decrease neonatal hypoglycemia,~     compared to usual antepartum care? The research study will also collect information about the~     relationship of timing of delivery after ALPS and neonatal hypoglycemia.~   "
37425|NCT03076762|"~     There is no consensus of the therapeutic efficacy and safety between suburothelial injection~     and trigonal injection of botulinum toxin A (BoNT-A) in treatment of interstitial~     cystitis/bladder pain syndrome (IC/BPS) It is unmet to clarify which injection method is~     superior in clinical efficacy and patient safety. This study was designed in a randomized,~     double-blind trial to test the therapeutic effects and adverse events between intravesical~     BoNTA injection into suburothelium and trigone. The results of this study might provide~     clinical evidence for a better therapeutic regimen of BoNT-A in the treatment of IC/PBS.~   "
37426|NCT03076749|"~     Background: ß-lactam (BL) antibiotics represent the main cause of allergic reactions to~     drugs, inducing both immediate and non-immediate reactions. The diagnosis is well~     established, usually based upon skin tests and drug provocation tests, but cumbersome.~      Objectives: To design predictive models for the diagnosis of BL allergy, based on the~     clinical history of patients with suspicions of allergic reactions to BL.~      Methods: The study included a retrospective phase in which records of patients consulting and~     explored for a suspicion of BL allergy (in the Allergy Unit of the University Hospital of~     Montpellier between September 1996 and September 2012) where used to construct predictive~     models; a prospective phase, in which we performed an external validation of the chosen~     models, in patients with suspicion of BL allergy recruited from 3 allergy centres~     (Montpellier, Nîmes, Narbonne), between March and November 2013. Data related to clinical~     history and allergy work-up results were retrieved and analysed. Logistic regression and~     decision tree method were used to design two models to predict the diagnosis of allergy to~     BL.~   "
37427|NCT03076736|"~     To undertake a pilot study that will evaluate the feasibility and acceptability of procedures~     to inform the design and delivery of a definitive RCT of SPA (which would assess the clinical~     and cost effectiveness of SPA for people with aphasia)~   "
37428|NCT03076723|"~     The purpose of the study is to determine if the so called pulsatility curve, which describes~     the relationship between intracranial pressure (ICP) and ICP pulsatility, can be used to~     predict outcome of treatment, in the form of shunt surgery, in idiopathic normal pressure~     hydrocephalus (INPH) and to guide the adjustment of shunt opening pressure after the surgery.~     The main hypotheses of the study are:~        1. The pulsatility curve may be the best auxiliary test to predict shunt surgery outcome in~          INPH patients. With a fixed shunt opening pressure, the preoperatively assessed~          potential pulse amplitude reduction (determined by analysis of the pulsatility curve)~          predicts postoperative improvement in gait velocity and cognitive functions.~        2. A postoperative pulsatility curve can be used to further optimize ICP pulsatility by~          guiding opening pressure adjustment. Shunt adjustment based on the pulsatility curve~          three months postoperatively will increase improvement, but not complications, compared~          to a shunt with fixed opening pressure.~      Based on these hypotheses, three specific aims for the study have been defined:~        1. To determine if improvement three month after surgery is associated with postoperative~          reduction in pulse amplitude.~        2. To determine if a pulsatility curve obtained preoperatively can predict improvement in~          gait velocity and cognitive functions in INPH patients three months after surgery.~        3. To compare outcome six months after surgery and complications rates between INPH~          patients with a fixed opening pressure versus those where the shunt has been adjusted~          based on the pulsatility curve, three months after the shunt insertion.~   "
37429|NCT03076710|"~     The primary objective of this pilot study is to assess the feasibility of comparing two~     standardized approaches to manage post-operative pain following spine surgery: one approach~     using Patient Controlled Analgesia (PCA) devices to deliver opioid analgesics, and the other~     approach using EXPAREL® infiltration at the site of surgery and nurse-administered opioid~     analgesics.~   "
37430|NCT03076697|"~     To validate new screening instruments for eye disease, increase eye care access in~     underserved communities, and provide a scientifically implemented method to set up programs~     for eye disease screening.~   "
37431|NCT03076684|"~     Increased stiffening of the heart and blood vessels is a predictor of heart disease.~     Stiffening has been found to be greater in women than men, which puts women with poor blood~     sugar control at a greater risk for heart disease than men. In women only, a molecule in the~     blood called uric acid can be elevated due to diets high in fructose consumption and it is~     thought to be a cause of heart and vessel stiffening. From previous research, we have found~     that restricting fructose in the diet lowers uric acid more in women than men. There is also~     a drug that can be used to lower uric acid. These findings suggest a potential approach to~     decrease vessel and heart stiffness in women. The present study will investigate fructose~     restriction in the diet and drug treatment to lower uric acid in the blood and its effects on~     heart disease risk in women compared to men.~   "
37432|NCT03076671|"~     This is a two-center (University of Colorado, University of California San Francisco)~     community-based comparative effectiveness study of outpatient palliative care for Parkinson's~     disease (PD) and related disorders (progressive supranuclear palsy (PSP), corticobasal~     degeneration (CBD), multiple systems atrophy (MSA), Lewy Body Dementia (LBD). It will utilize~     a randomized stepped-wedge design to compare patient and caregiver outcomes between usual~     care in the community versus usual care augmented by palliative training and telemedicine~     support to provide other resources (e.g. social work).~   "
37433|NCT03076658|"~     A study of the skeletal structure and how the structure changes over time. The aim of the~     study is to evaluate the skeleton in 10 year increments to determine an understanding of the~     normal skeleton as a person ages. By using x-ray analysis, a new low dose x-ray system (EOS)~     can be used to evaluate the whole body to see changes in the bone structure over time.~     Subjects will be asked to undertake one x-ray analysis of their whole body skeletal~     structure. There will be 25 male and 25 female subjects per decade. The averaging of the~     measured skeletal parameters will provide information on changes over time generating a~     standardized expectation of general changes in skeletal structure as participants age.~   "
37434|NCT03076645|"~     This study will measure the engagement of people with epilepsy in a mobile phone based~     messaging platform as well as understand if there is an impact on their self-management~   "
37435|NCT03076632|"~     -  People with cervical spinal cord injury (SCI) and amyotrophic lateral sclerosis (ALS)~          have reduced connections in the nerve circuits between the brain and the hands.~          Activating spared nerve circuits is one potential way to improve recovery.~        -  The investigators are testing different combinations of physical wrist and hand~          movements paired with magnetic brain stimulation and electrical spinal cord or nerve~          stimulation to see the effects on nerve transmission to hand muscles.~        -  This is a preliminary study. This study is testing for temporary changes in nerve~          transmission to hand muscles. There is no expectation of long-term benefit from this~          study. If temporary changes are seen in this study, then future studies would focus on~          how to prolong that effect.~   "
37436|NCT03076619|"~     Toxemia of pregnancy is a recognized entity for over 2000 years with its known complications~     and fatality. Nowadays, a most accepted terminology for the following defined syndrome is~     hypertensive disorders in pregnancy given by American College of Obstetrics and Gynecology.~     It is an important cause of maternal and fetal morbidity and mortality. Pregnancy induced~     hypertension (PIH) was classified as gestational hypertension, preeclampsia, severe~     preeclampsia and eclampsia. PIH is a hypertensive disorder in pregnancy that occurs after 20~     weeks of pregnancy in the absence of other causes of elevated blood pressure (BP) (BP >140/90~     mmHg measured two times with at least of 4 hour interval) in combination with generalized~     edema and/or proteinuria (>300 mg per 24 hrs). When there is significant proteinuria it is~     termed as preeclampsia; seizure or coma as a consequence of PIH is termed as eclampsia.~     Preeclampsia was classified into mild and severe preeclampsia.~      Mild eclampsia—BP >140/90 mmHg, proteinuria+, and/or mild edema of legs, Severe~     preeclampsia—BP >160/110 mmHg,proteinuria++ or ++++, headache, cerebral or visual~     disturbances, epigastric pain, impaired liver function tests and increase in serum~     creatinine.~      Proteinuria was tested using dipstick method as +=0.3 gm/L, ++=1 gm/L, and +++=3 gm/L.~      The pathological changes of this disease appear to be related to vascular endothelial~     dysfunction and its consequences (generalized vasospasm and capillary leak). Ocular~     involvement is common in PIH.Common symptoms are blurring of vision, photopsia, scotomas and~     diplopia. Visual symptoms may be the precursor of seizures.Progression of retinal changes~     correlates with progression of PIH and also with the fetal mortality due to similar vascular~     ischemic changes in placenta.Vasospastic manifestations are reversible and the retinal~     vessels rapidly return to normal after delivery. Ophthalmoscope should be rated next to the~     sphygmomanometer as an instrument of diagnostic importance in cases of PIH. Ophthalmoscopy~     does not only helps in diagnosing the disease but repeated observations assist in assessing~     the severity, progress of disease, response to treatment if any and ultimate outcome or~     prognosis.~   "
37437|NCT03076606|"~     Nurses participate to geriatric evaluations for falling patients. For these patients, it is~     recommended to evaluate,especially, visual acuity but this is not currently done because it~     is difficult to systematically combine with an ophthalmologic consultation.~      The HAS french recommendations propose to detect visual acuity deficiency using Monoyer and~     Parinaud scales, without specifying the professional qualification. According to the nurse~     competence decree of State Graduates, sensory disorders screening is a non-vulnerable~     examination, and can be performed by nurses. Therefore, they can use these scales, after~     training.~      We propose to evaluate the correlation between visual acuity scores obtained by nurses in~     geriatric consultations and an ophthalmologist.~      This study should include 204 patients over 65 years, who have fallen at least twice in the~     last 12 months. These patients will benefit from an evaluation by an ophthalmologist, after~     the geriatric consultation.~   "
37438|NCT03076593|"~     GAPcare (Geriatric Acute & Post-acute Care Coordination Program for Fall Prevention) is an~     early stage investigation that surveys older adults who present to the Emergency Department~     for any illness to determine the feasibility of an Emergency Department (ED)-based~     multidisciplinary intervention for preventing recurrent falls in older adults. In this~     observational study, older adults will be approached during routine clinical care in the ED~     and asked about prior falls, prior experiences having falls treated in the inpatient and~     outpatient setting, and the investigators will solicit feedback on potential improvement to~     care in the ED setting for falls.~   "
37440|NCT03076567|"~     Background:~      Stomach cancer is common around the world. The US is a low-risk region. But the 5-year~     survival rate in the US is low. This is because the cancer is usually in a late stage by the~     time it is diagnosed. One way to detect it earlier is to screen many people with a procedure~     called endoscopy. But this may not be feasible in low-risk or developing countries.~     Researchers want to find a biomarker for early-stage disease to help them create an effective~     way of screening. DNA methylation is a chemical modification of DNA. It generates a signal~     for certain cancers, including stomach cancer. Researchers want to find a blood-based DNA~     methylation marker for stomach cancer.~      Objective:~      To study plasma DNA methylation as a potential biomarker for detection of stomach cancer.~      Eligibility:~      Participants from 2 studies already done in China~      Design:~      Researchers will use blood samples from participants in the 2 studies. The blood was~     collected in 1999/2000. They will use samples from some who developed stomach cancer between~     those years and 2006. The other samples will be from some who stayed cancer free in that~     time.~      Participants already gave written informed consent.~      Researchers will take DNA from the samples. They will look for methylation.~   "
37441|NCT03076554|"~     Background:~      Thymoma and thymic carcinoma are cancers originating in the thymus gland. Platinum-based~     chemotherapy is standard treatment for them. But not uncommonly, the disease returns and~     people need more treatment to keep the cancer from growing. The drug Avelumab could help the~     immune system fight cancer.~      Objective:~      To test if avelumab is safe and well-tolerated, and is effective in treating relapsed or~     refractory thymoma and thymic carcinoma.~      Eligibility:~      People ages 18 and older with thymoma or thymic carcinoma that has returned or progressed~     after platinum-containing chemotherapy~      Design:~      Participants will be screened with:~        -  Blood, urine, and heart tests~        -  Scan: They lie in a machine that takes pictures of the body.~        -  Physical exam~        -  Medical history~        -  Biopsy: a needle removes a piece of tumor. Samples can be from a previous procedure,~          although it is desirable to undergo a new biopsy.~      Participants will have treatment in 2-week cycles. They will continue until the side effects~     are not tolerable or their disease gets worse.~      Visits at the following time points are required per protocol:~        -  Every 2 weeks: Participants will get avelumab by infusion in a vein (IV). They will get~          diphenhydramine (benadryl) and acetaminophen (tylenol) by mouth or IV before receiving~          avelumab to decrease the chances of developing a reaction to avelumab. They will have~          blood, urine, and heart tests periodically.~        -  Cycles 4 and 7, then every 6 weeks: Scans will be performed to look for shrinkage or~          growth of tumor.~        -  Cycle 4: Participants will be offered a chance to undergo a biopsy.~        -  2 4 weeks after stopping treatment: Blood, urine, and heart tests will be performed.~          Participants might undergo a scan.~        -  10 weeks after stopping treatment: Blood, urine, and heart tests.~        -  About 6 months after stopping treatment, then every 3 months: Participants will have~          scans andcan allow genetic testing on their blood and tissue samples.~   "
37442|NCT03076541|"~     Periodic leg movements during sleep is associated with microarousals and a stimulation of the~     sympathetic nervous system. The knowledge of this autonomic activation may help understanding~     the increase of cardiac risk observed in elderly. The aim of the study is to evaluate the~     relationship between periodic leg movements severity, age, gender, electromyographic power~     and heart rate response associated with periodic leg movements. Drug-free patients diagnosed~     with periodic leg movements were included. Clinical data and 24-h polysomnography recordings~     were analyzed.~   "
37443|NCT03076528|"~     Among patients with diabetes 35% suffer from chronic renal disease and may require dialysis~     or kidney replacement over time. Furthermore, in diabetics with end stage renal disease~     (ESRD) that require dialysis, the risk of foot complications and amputation is even more~     common, expensive, and devastating. Interestingly, even though incidence of foot ulcers in~     patients with dialysis has been reported to be same as with patients with history of foot~     ulcers; dialysis patients have significantly higher rate of foot amputation.~      The goal of this research is to incorporate an innovative virtually supervised non-weight~     bearing exercise in patients undergoing dialysis to reduce risk of fall and foot ulceration~     by enhancing lower extremity blood flow, joint perception and joint mobility.~      Diabetic patients on hemodialysis at Hamad Medical Company will be recruited and will be~     randomized to either intervention (IG) or control (CG) group and followed for 6 months. The~     intervention group will take part in a 4-week non-weight bearing exercise program twice per~     week at the hemodialysis clinic under the supervision of a qualified research staff member.~     This intervention includes interactive game-based exercises including repetitive ankle and~     foot movements. Wearable sensors will provide real-time visual/auditory feedback from foot~     and ankle position and allowed perception of motor-errors during each motor-action. The~     control group will be instructed to complete a supervised foot and ankle exercise without~     using sensor technology. Changes in balance, gait, and physical activity, incidence of foot~     problems will be compared pre- and post-intervention. In addition, the incident of falls,~     foot ulcers, and limb amputation up to 6 months post intervention will be documented.~     Investigators hypothesize that patients receiving sensor-based exercises will benefit more~     compared to group receiving conventional non-technology training in terms of improving~     functional performance and reducing incidence of foot problems, falls, and limb amputation.~   "
37444|NCT03076515|"~     This is a prospective, randomized, double-blind, sham controlled multi-center trial. Ratio~     between treatment and control groups will be 1:1, stratified by center and use of preventive~     medications.~   "
37445|NCT03076502|"~     This study aims to evaluate the role of ct-DNA, PVT1 and reactive oxygen species (ROS) as~     biomarkers in the diagnosis, treatment and recurrence monitoring of gastrointestinal and~     hepatobiliary pancreatic cancer.~   "
37446|NCT03076489|"~     This study includes an inclusion visit, 2 visits to the Rennes University Hospital and the~     filling of two on-line questionnaires.~      The first visit to the University-Hospital of Rennes, during which a blood sample will be~     taken, morpho-anatomic measures (height, weight, hip and size), impedancemetry and resting~     energy expenditure by indirect calorimetry will be carried out in the Clinical Investigation~     Unit.~      During this visit, the volunteers will also have to bring a sample of urine and faeces~     previously collected at home.~      The two on-line questionnaires (hedonic and caloric evaluation of foods and beverages on~     photos) will have to be completed by the volunteers between the first and the second visit to~     the University-Hospital.~      Finally, the volunteers will go to the University-Hospital of Rennes for the second visit, on~     the Neurinfo platform, during which they will be subjected to a cognitive two-choice test~     based on food and drink pictures, during fMRI. Before and after the fMRI session, an~     assessment of the state of hunger, thirst, and general status of the volunteer will be~     carried out using a numerical scale ranging from 1 to 10.~   "
37447|NCT03076476|"~     Angina and heart attacks are caused by narrowings in the coronary arteries (blood vessels)~     supplying the heart. These narrowings can be opened using a balloon and stent (angioplasty).~     Traditionally, stents are constructed from metal and are permanent. However, newer stents are~     being constructed from carbohydrate polymers (scaffolds), which allow them to reabsorb over~     time leaving no permanent implant. New data has suggested that these scaffolds appear to~     reduce recurrent angina and may alter the blood flow down the artery. However, it is not~     known whether this is due to the scaffolds themselves or the way the scaffolds are inserted.~     In this study we hope to measure the blood flow to the heart and assess changes in that flow~     during stent and scaffold insertion. It is also important to know whether these effects are~     durable and thus, a cohort of patients will return at 3-months to be restudied. These data~     are important to help us understand why blood flow is affected by stent/scaffold selection or~     device implantation technique and whether this results in better long-term outcomes.~   "
37448|NCT03076463|"~     The aim of this is study is to evaluate the long-term effects of grape polyphenols in the~     modulation of markers of metabolic syndrome. Most of the previous works about polyphenols~     have only considered a fraction of polyphenols, i.e., extractable polyphenols. As a~     consequence, an important amount of dietary polyphenols, the so-called non-extractable~     polyphenols are ignored. In contrast, the effect of both extractable and non-extractable~     polyphenols will be considered in this study. Also, studies on the long-term effect of grape~     polyphenol on markers of metabolic syndrome have been mostly conducted in animals, so~     clinical trials on this topic are needed.~   "
37449|NCT03076450|"~     Using lung ultrasound re-aeration score(LUS-RAS) combined with pressure-volume curve(PVC)~     adjust maintain positive end-expiratory pressure(PEEP) after recruitment maneuver, to achieve~     real-time adjustment, reduce ventilation-associated lung injury and the purpose of effective~     lung recruitment.~   "
37450|NCT03076437|"~     Autologous T cells engineered to express an anti-CD19 chimeric antigen receptor (CAR) will be~     infused back to patients with B cell malignancies, including lymphoma and leukemia. The~     patients will be monitored after infusion of anti-CD19 CAR-transduced T cells for adverse~     events, persistence of anti-CD19 CAR-transduced T cells and treatment efficacy.~      Objectives:~      To evaluate the safety and the efficacy of anti-CD19 CAR-transduced T cell therapy for~     patients with B cell malignancies.~      Eligibility:~      Patients between 1 and 80 years of age, who have relapsed or refractory CD19-expressing~     B-cell malignancies (leukemia or lymphoma) that have not responded to standard treatments.~      Patients with a history of allogeneic stem cell transplant who meet all eligibility criteria~     are eligible to participate.~      Patients must have adequate organ functions.~      Design:~      Peripheral blood from patients will be collected for isolation of peripheral blood~     mononuclear cells (PBMCs), which will be transduced with a lentiviral or retroviral vector~     encoding anti-CD19 CAR containing a CD28 or 4-1BB and a CD3 zeta as costimulatory domains.~      Patients will receive a lymphodepleting preconditioning regimen to prepare their immune~     system to accept modified T cells.~      Patients will receive an infusion of their own modified T cells. They will remain in the~     hospital to be monitored for adverse events until they have recovered from the treatment.~      Patients will have frequent follow-up visits to monitor the persistence of modified T cells~     and efficacy of the treatment.~   "
37451|NCT03076424|"~     The purpose of this study is to investigate a persons dietary intake and its effect on the~     gut microbiome and the association of those two variables on weight and glucoregulation.~     Specifically, the investigators will compare the gut microbiota, fasting glucose and insulin,~     c-peptide and hemoglobin A1-c in three groups of subjects: obese patients (BMI ≥ 30 kg/m2)~     with type 2 diabetes mellitus (T2DM), obese patients without T2DM, and normal weight lean~     controls without T2DM. Each patient will also complete a detailed dietary recall (ASA-24) to~     investigate the association with diet, microbiome and weight/glucoregulation.~   "
37452|NCT03076411|"~     This non-interventional, observational study investigates the course of symptoms in patients~     with functional dyspepsia under treatment with a fixed combination of pepsin and amino acid~     hydrochloride over a period of approximately 6 weeks. The change of the Gastrointestinal~     Symptom Score (GIS©) was the primary parameter for the assessment of efficacy and was~     performed at baseline, after 3 and 6 weeks of treatment respectively. Safety measures~     included recording of AEs and physical examination as well as measurement of vital signs. The~     aim was to observe 100 patients during the course of this non-interventional study.~   "
37453|NCT03076398|"~     Normally, anaesthesia personnel make a record patients' information during the surgical~     procedure. Pre and post-operatively, they visit patients to make sure that their customers~     are well informed regarding the whole process and satisfied with the service as well as any~     complications that might be existed.~      The investigators would like to develop an anaesthesia electronic medical record at the point~     of care. The objectives are to record peri-operative patients' information in a real-time~     fashion, manage all administrative tasks as annual reports, and operate data as search engine~     for research and educational purpose.~   "
37454|NCT03076385|"~     This clinical study will assess the safety, tolerability and immunogenicity of VAL-506440 in~     healthy adult subjects.~   "
37455|NCT03076372|"~     MM-310 is a liposomal formulation of a docetaxel prodrug that targets the EphA2 receptor on~     cancer cells. Docetaxel is an approved chemotherapeutic drug.This study is a Phase 1~     open-label study of MM-310 in patients with solid tumors. In the first part of the study,~     MM-310 will be assessed as a monotherapy until a maximum tolerated dose (MTD) is established.~     After an MTD of MM-310 as a monotherapy is established, an expansion cohort and MM-310 in~     combination with other therapies will be assessed.~   "
37456|NCT03076359|"~     The overall goal of this project is to adapt and assess the impact of a traditional healer~     training program/intervention on the adherence, retention, and viral load of HIV infected~     patients newly initiated on anti-retroviral therapy (ART) in rural Mozambique.~   "
37457|NCT03076346|"~     Clozapine has consistently shown to be a superior drug for psychosis in patients who do not~     respond to other treatments, but its mechanism of action remains unknown. The overall goal of~     this study is to examine the functional neural circuitry that underlies successful treatment~     with clozapine, which may lead to the identification of biomarkers that will allow for more~     efficient use of clozapine, as well as additional treatment targets for patients with~     refractory illness.~   "
37458|NCT03076333|"~     Purpose: To assess the utility of PET/MR in assessing response to neoadjuvant radiation~     therapy in the treatment of high grade sarcomas.~      Participants: Adult patients with potentially curable high grade sarcomas that are being~     treated at UNC with neoadjuvant radiation therapy followed by potentially curative surgical~     resection.~      Procedures (methods): Patients who are being treated for potentially curable high grade~     sarcomas with neoadjuvant radiation therapy followed by surgical resection undergo~     pre-treatment, mid-treatment, and post-treatment PET/MR and the response to treatment is~     assessed by evaluating change in size and FDG avidity. Patients then undergo curative intent~     resection and are followed. Their pathology is reviewed for treatment affect as is assessed~     by percent necrosis, size, and resection margins. Patients are followed and assessed for~     recurrence.~   "
37459|NCT03076320|"~     Acne vulgaris is a complex skin disorder involving multiple abnormalities of the~     pilosebaceous unit. Acne is the most common skin disease during puberty and worsens~     throughout adolescence. However, epidemiological studies suggest that acne can arise at any~     age, most frequently affecting individuals between puberty and 30 years of age, with 79%-95%~     of subjects aged between 16 years and 18 years and 80% of subjects between puberty and 30~     years of age. Acne is considered the main reason for consultation with the dermatologist in~     institutional and private clinical practice.~      Clinical features include seborrhoea, non-inflammatory lesions, inflammatory lesions and~     various degrees of scarring. There are many classifications of acne and scarring severity.~     Moderate to severe acne is about 15-20%.~      Facial acne scarring affects both sexes equally and occurs to some degree in up to 95% of~     cases. There is a significant correlation between the initial acne grade and the overall~     severity of scarring at all sites and in both sexes. This would suggest that treatment aimed~     at reducing the severity of acne might reduce the incidence of scarring. Both superficial~     inflammatory acne lesions as well as deep nodular lesions seem capable of producing scars.~      Conventional therapies recommended for the treatment of acne vulgaris include retinoids,~     benzoyl peroxide (BPO), antibiotics, and hormonal therapy. Combination therapy using agents~     with complementary mechanisms provides the opportunity to target multiple pathogenetic causes~     of acne vulgaris.~      The combination in gel with 0.1% adapalene and 2.5% BPO is a once-daily treatment of acne~     vulgaris. In several double- blind, randomized controlled trials (RCTs), the Adapalene-BPO~     (A-BPO) combination therapy applied once daily for 12 weeks significantly reduced the number~     of both inflammatory and non-inflammatory lesions in subjects with moderate acne vulgaris. In~     Mexico there is an available commercial product of this combination (Effezel®; Galderma). The~     limitation of this topical therapy is the low tolerability by patients as they can experiment~     several levels of irritation, erythema, dryness, desquamation, burning, and itching), and~     patients are advised to expect these side effects, which contribute to discontinue therapy if~     it becomes severe.~      On the other hand, 5-methyl-1-phenyl-2-(1h)-pyridone or pirfenidone (PFD) is a wide-spectrum~     antifibrotic drug that modulates diverse cytokines action, involving TGF-β, TNF-α, epidermal~     growth factor, platelet-derived growth factor, VEGF, IGF-1, fibroblast growth factor,~     interferon-γ, interleukin (IL)-1, IL-6, and IL-8 and it has shown promising effects in vitro~     and in vivo settings. Also, PFD has proven effective in the prevention and regression of~     pulmonary fibrosis, peritoneal sclerosis, hepatic cirrhosis, uterine fibromyoma, left~     ventricular fibrosis, renal interstitial fibrosis, and breast capsular contracture in~     experimental models. A recently open phase II clinical trial evaluated the therapeutic use of~     PFD gel in localized scleroderma. Results showed it acts on both the inflammatory and the~     fibrotic phases.~      The other component of Zaxcell is modified-diallyl disulfide oxide (M-DDO) an antimicrobial~     and antiseptic agent, which has been proved in patients with chronic diabetic ulcer as a~     potent germicide and has show to increase the beneficial effect of PFD preventing infections,~     accelerating and improving ulcer resolution. (Observations not published).~      According to this, the investigators believe that Zaxcell (PFD + M-DDO) could play an~     important role in the modulation of inflammatory and scarring process in acne. The~     investigators hypothesis is that PFD in patients with moderate to severe acne modulates~     amplification of the inflammatory response, regulating the inflammasome activation,~     macrophage polarization and its activity in regulating the wound healing process of the skin~     in an early fashion.~      Zaxcell is an innovative gel with a synergetic mode of action that could modulate the~     inflammatory response. Furthermore, has antiseptic properties and regulates the process of~     wound healing, fibrogenic and scarring process. In vitro and in vivo studies provide an~     initial body of evidence on the safety and clinical benefits of PFD, the main component of~     Zaxcell as a promising candidate for the treatment of moderate to severe acne.~   "
39954|NCT03043742|"~     Assess the safety and effectiveness of stem cell application with regard to improvement in~     regional myocardial function in patients receiving Trans-Myocardial Laser Revascularization~     (TMR) and stem cells.~   "
37460|NCT03076307|"~     Patients with Parkinson's disease (PD) are known to be affected by subtle cognitive~     impairment early in the disease course, mostly in the executive field. Procedural motor~     skills, mainly controlled by the basal ganglia associative loop (in particular dorsal caudate~     nucleus) (Rodriguez-Oroz et al., 2009), have also been studied in patients with PD (Schnider~     et al., 1995; Muslimovic et al., 2007; Terpening et al., 2013). However, the correlation of~     dopaminergic 123I-FP-CIT SPECT imaging and cognitive impairment has not been assessed. One~     reason is the absence of reference values for striatal uptake until recently. Last year, the~     investigators established local uptake reference values for DAT imaging based on a large~     cohort of subjects with non-degenerative conditions (Nicastro et al., 2016) and can therefore~     use these values to precisely assess uptake loss in patients with PD.~      With the present study, the investigators expect to enroll patients with early PD for whom a~     123I-FP-CIT SPECT has been previously performed in the center. Subjects will perform a~     specific motor task based on mirror-drawing of star-shaped figures. This will be done by~     inverting the direction of horizontal/vertical computer mouse movements on the screen. Speed~     and error rates will be assessed for patients as well as healthy control subjects.~     Correlation with striatal SPECT uptake, especially caudate nucleus uptake, will be analyzed~     for PD patients. In addition, resting-state EEG will be performed for all subjects. General~     medication and dopaminergic drugs in particular, whenever used, will not be discontinued. For~     all subjects enrolled in the study, cognitive and neurological examination will be performed.~   "
37461|NCT03076294|"~     In this study, the investigators wondered whether the association between high frequency~     repetitive transcranial magnetic stimulation (hf-rTMS) and manual therapy (peripheral and~     central approach) is more effective in reducing pain levels and modulation of cortical~     activity of chronic knee ostearthritis pain subjects than manual therapy alone (usual~     peripheral approach). For this purpose, patients included will be submitted to one session~     with active or sham hf-rTMS followed by a protocol of manual therapy. Besides that another~     active group will have the sequence of interventions exchanged (manual therapy followed by~     hf-rTMS) in order to investigate whether this may influence in the final outcomes.~   "
37462|NCT03076281|"~     This randomized phase II trial studies how well metformin hydrochloride and doxycycline work~     in treating patients with head and neck squamous cell carcinoma that can be removed by~     surgery. Metformin hydrochloride may reduce the metabolic activity of cancer cells and of~     surrounding supportive tissue. Doxycycline may minimize toxic side effects of anti-cancer~     therapy. Giving metformin hydrochloride and doxycycline may work better in treating patients~     with head and neck squamous cell carcinoma.~   "
37463|NCT03076268|"~     Treinta Millones de Palabras- Visitas al Hogar (TMP) is designed to intervene upon mothers'~     knowledge, beliefs, and behavior, which in turn influences their interaction with their~     children, impacting children's development. The investigators will measure change in mothers'~     knowledge, beliefs, and behavior during and after intervention, and measure impacts on~     children's development across major developmental domains. Specifically, the investigators~     will measure mothers'~        1. Knowledge of child language development and the role of parents in that development~        2. Beliefs about the malleability of intelligence and their role in shaping their~          children's intelligence~        3. Interaction with their child, specifically their linguistic input and responsiveness to~          their child's communication~      Concurrently, the investigators will measure children's~        1. Emergent oral language development, in both Spanish and English~        2. Social-emotional development~        3. Math and spatial reasoning skill development~   "
37464|NCT03076255|"~     This pilot clinical trial studies how well head and neck maskless immobilization device works~     in immobilizing patients with intracranial tumors undergoing radiation therapy. Maskless~     immobilization device may help to prevent movement of head during radiation therapy and~     immobilize patients with the same accuracy and reliability as the standard thermoplastic mask~     routinely used for patients with brain tumors receiving radiation therapy.~   "
37465|NCT03076242|"~     This is a prospective research registry and prospective genetic testing cohort study. The~     goal is to collect personal medical and cancer history data, family cancer data, exposure~     history, and biospecimens to support research focused on optimal genetic testing strategies~     for men with prostate cancer with the ultimate goal of informing national guidelines focused~     on genetic evaluation for prostate cancer.~   "
37466|NCT03076229|"~     The purpose of this study is to evaluate the effectiveness of relationship education (RE) for~     individuals and couples participating in Project Harmony.~   "
37467|NCT03076216|"~     To evaluate the safety of OncoSil™ in a patient population undergoing standard chemotherapy~     treatment for pancreatic cancer. This study has been designed to satisfy FDA regulatory~     requirements.~      The clinical investigation will be conducted at approximately 5 sites in the United States~     involving 20 patients.~   "
37468|NCT03076203|"~     This phase Ib trial studies the side effects and best dose of niraparib when given together~     with radium Ra223 dichloride in treating subjects with prostate cancer that keeps growing~     even when the amount of testosterone in the body is reduced to very low levels and has spread~     from the primary site to the bone. Radium Ra 223 dichloride, acts like calcium to target~     cancer in the bones and may deliver radiation directly to the bone tumors, limiting damage to~     the surrounding normal tissue. Niraparib may stop the growth of tumor cells by blocking some~     of the enzymes needed for cell growth. Giving radium Ra 223 dichloride and niraparib may work~     better in treating subjects with hormone-resistant prostate cancer metastatic to the bone.~   "
37478|NCT03076073|"~     The aim of the current study is to evaluate the Patellar tendon and Achilles tendon~     structures among children, adolescents and adults with different weight status. That in order~     to improve our understanding on the impact of acute and overused loads on tendon structure;~     and, in developing strategies to reduce tendon's injuries following physical exercises.~   "
37479|NCT03076060|"~     Ketogenesis is a physiologic phenomenon due to starvation or ketogenic diet (KD), a drastic~     restricted carbohydrate dietary regimen that induces lipid metabolism and ketone body (KB)~     synthesis. We followed, in a dietician clinical setting, a group of migraineurs who randomly~     received a one-month prescription of experimental diet, followed by a one-month of~     carbohydrate progressive reintroduction, then another one-month of experimental diet,~     followed by a one-month of carbohydrate progressive reintroduction. Experimental diets are a~     very-low calorie KD, or an isocaloric non-ketogenic diet.~      Aim of our study is verify if during ketogenesis migraine improves.~   "
37469|NCT03076190|"~     The primary purpose of this study is to determine the feasibility and preliminary efficacy of~     a remote, Internet-based, pre-surgical psychoeducational intervention delivered to patients~     scheduled for breast cancer surgery (compared to an active control group that receives health~     education).~      Aim 1: Determine feasibility, satisfaction, and perceived utility of My Surgical Success.~      Hypothesis 1: For My Surgical Success, the investigators anticipate 50% engagement in the~     study (feasibility). Of those who complete My Surgical Success we expect 80% satisfaction~     ratings, and 80% perceived utility of the information learned.~      Aim 2: Determine group differences in within-subject pain catastrophizing scores (baseline -~     0 to 48 hours before surgery).~      Hypothesis 2: My Surgical Success participants evidence greater reduction in pain~     catastrophizing (measured with the Pain Catastrophizing Scale; PCS) compared to the HE~     Control group.~      Aim 3: Determine group differences in time to post-surgical pain and opioid cessation.~      Hypothesis 3: My Surgical Success participants will evidence quicker time to post-surgical~     pain and opioid cessation compared to the HE Control Group.~      Aim 4: Determine group differences in post-surgical psychological correlates (PROMIS~     Depression, Anxiety, Function, Pain Interference, Sleep Disturbance, Sleep Related~     Impairment, Anger, Fatigue, Global, Distress, and Pain Intensity).~      Hypothesis 4: My Surgical Success participants will evidence greater post-surgical function~     and lower pain related interference compared to the HE Control Group.~      The goal of this research is to advance our understanding regarding the feasibility and~     effectiveness of remote psychoeducation interventions and impact on post-surgical outcomes.~   "
37470|NCT03076177|"~     Purpose of our study is to evaluate effectiveness of Kinesio Taping method for knee~     osteoarthritis. Using simple concealed randomization procedure to form two groups (kinesio~     taping and control-nonspecific taping) of 100 knee osteoarthritis patients in each. 1 month~     all patients (depending on the group they will be allocated to) will receive either kinesio~     taping applications or non-specific taping: 4 applications per subject. Three times: before~     taping, after a month with tapes, and after 1 month without tapes evaluation of knee~     function, mobility, quality of life will be evaluated, including clinical examination of knee~     joint, measurements of knee flexion and extension by goniometer, circumference of leg over~     the knee, in ½ of thigh and in ½ of calf (to evaluate edema); pain will be evaluated by~     questionnaire, patella tendon algometry; force of calf flexors and extensors will be~     evaluated using Lovett manual muscle testing scale, goniometry for knee flexion/extension;~     for mobility, knee function, life quality evaluations - 10 Meter Walk , Five Times Sit to~     Stand Tests will be performed, Knee injury and Osteoarthritis Outcome Score (KOOS) and~     Medical Outcomes Study Short Form 36 2 version (SF-36 2v) questionnaires will be used. Also~     data about the need of analgesic medicament will be collected from subjects.~   "
37471|NCT03076164|"~     The purpose of this study is to determine the safety, tolerability and overall response rate~     of trametinib when given in combination with erlotinib in patients with Stage IV or recurrent~     lung adenocarcinoma that cannot be treated with curative intent.~   "
37472|NCT03076151|"~     Tacrolimus is a calcineurin inhibitor widely used for the prevention of allograft rejection~     in solid organ and bone marrow transplantation. It is characterized by a narrow therapeutic~     index and large inter-individual pharmacokinetic variability. Adoport® is an~     immediate-release formulation of tacrolimus, to be administered twice daily. Because of a~     narrow therapeutic window and a better correlation between pre-dose level and effects than~     between dose and effect, therapeutic drug monitoring (TDM) based on trough whole blood~     tacrolimus concentrations is recommended for Adoport®. TDM helps to minimize the risk of~     acute rejection and the occurrence of adverse effects (mainly nephrotoxicity and, to a lesser~     extent, neurotoxicity).~      As reported in a consensus document from a consortium of European experts on tacrolimus TDM,~     the interdose area-under-the curve (AUC0-12h) is expected to be the best marker of tacrolimus~     exposure. However, tacrolimus monitoring based on full AUC0-12h is difficult to set up in~     routine, due to clinical constraints and the necessity of multiple samples. Calculation of~     the AUC0-12h using Bayesian estimation and a limited sampling strategy, i.e. a few blood~     samples collected during the early phase post-dose would represent an elegant solution, as~     already done for other tacrolimus formulations.~      Furthermore, the pharmacokinetics (PK) of tacrolimus is influenced by a single nucleotide~     polymorphism within intron 3 of cytochrome P450 3A5 (CYP3A5). Patients who carry at least one~     CYP3A5*1 allele are considered to be CYP3A5 expressors (about 12% of the Caucasian~     population, Hapmap project) and thus require a 1.5 to 2-fold higher starting dose than~     CYP3A5*3/*3 carriers to reach the predefined target exposure early after transplantation.~     Although this polymorphism showed no impact on the performance of the Bayesian estimators~     previously developed for other tacrolimus formulation, the patient status for CYP3A5*3 will~     be considered in this pharmacokinetic study as a potential covariate in, or confounding~     factor of, the PK model. Specifically, owing to a 12% frequency in the White European~     population, about 4 patients carriers of the CYP3A5*1 allele are expected in this study; the~     performance of the PK model and Bayesian estimator developed will be specifically evaluated~     in this subgroup.~   "
37473|NCT03076138|"~     The purpose of this study is to evaluate the safety and efficacy of the gene-activated bone~     substitute consisting of octacalcium phosphate and plasmid DNA encoding vascular endothelial~     growth factor (VEGF) for maxillofacial bone regeneration. The patients with congenital and~     acquired maxillofacial bone defects and alveolar ridge atrophy will be enrolled.~   "
37474|NCT03076125|"~     The purpose of this study is to test the efficacy of the Stroke Counseling for Risk Reduction~     (SCORRE) intervention in increasing accuracy of perceived stroke risk and promoting lifestyle~     behavior change to reduce stroke risk in young adult African Americans.~   "
37475|NCT03076112|"~     The objectives of this study are 1) to compare the effect of ipragliflozin 50 mg on~     glucose-lowering effect with sitagliptin 100 mg in patients with type 2 diabetes mellitus,~     whose HbA1c level is ≥ 7.5% with sulfonylurea and metformin, 2) to investigate changes of~     other metabolic and cardiovascular risk factors such as triglyceride, HDL-cholesterol, uric~     acid, blood pressure, and inflammatory markers, 3) to examine changes of body composition~     including fat and muscle mass with volume status.~   "
37476|NCT03076099|"~     Aim of this trial is to study the effect of Dexmedetomidine on post-operative blood pressure~     in patients undergoing brain arteriovenous malformation embolization. The patients were~     randomized allocated to either Dexmedetomidine group or Control group. Patients in~     Dexmedetomidine group will receive intravenous Dexmedetomidine while the control group will~     receive normal saline. Post-operative anti-hypertensive drug, Visual analogue~     score,post-operative analgesics consumption, Quality of Recovery score, Ramsay score, and~     adverse events were recorded.~   "
37477|NCT03076086|"~     The aim of this study is to validate two new biomarkers in sputum samples. These are PiP3~     (phosphoinositolphospat ) and phosphor proteins, representing important proteins within~     inflammatory situations of the lung.~   "
37480|NCT03076047|"~     To understand if a progressive increase in end-tidal carbon dioxide (CO2) levels are~     heralding respiratory difficulties before desaturation measured from capnography in~     obstructive sleep apnea patients.~   "
37481|NCT03076034|"~     The objective of this study is to determine whether a new minimally invasive method for in~     vivo measurement of cortical bone tissue properties can identify those who are at risk for~     fragility fractures of the hip and radius. The investigators hypothesis is that women with~     fragility fractures of the hip and radius have altered cortical bone tissue properties~     compared to non-fracture controls independent of standard clinical tests, such as bone~     mineral density (BMD) by dual-energy x-ray absorptiometry (DXA).~   "
37482|NCT03076021|"~     Specific Aim: To investigate if isotretinoin (13-cis-retinoic acid) administration decreases~     CYP2D6 activity in adolescent patients.~   "
37483|NCT03076008|"~     The investigators plan to perform a prospective observational cohort study of patients~     undergoing MPFL reconstruction for the treatment of episodic patellar instability in the~     absence of significant degenerative disease. The investigators will follow these study~     subjects for a minimum of two years to monitor their functional and clinical outcome.~   "
37484|NCT03075995|"~     Food can make a big difference on the bioavailability of lapatinib in breast cancer~     patients,and fatty food can increase the lapatinib bioavailability.By examine the steady~     blood drug concentration in the same individual at different treatment mode for~     lapatinib,emptiness or taken with fatty food,discuss the best mode of taking lapatinib with~     fatty food.~   "
37485|NCT03075969|"~     The objective of this study is to test the scale structure, reliability, validity and~     responsiveness to change of the QLQ-CML24 in conjuction with the QLQ-C30 for patients~     diagnosed with CML, and to investigate longitudinal relationship between satisfaction with~     information provision and QoL outcomes.~   "
37486|NCT03075956|"~     Estetrol (E4) is being developed in two indications supporting women health care: first E4 is~     combined with a progestin, [drospirenone (DRSP)] and is used as a new combined oral~     contraceptive (COC) for the prevention of pregnancy and secondly, E4 is used alone as new~     hormone replacement therapy (HRT) for the treatment of menopause related symptoms.~      The current clinical trial is designed to collect more detailed information about the PK~     profile, safety and tolerability of different dosages of E4, given orally as a solid tablet.~   "
37487|NCT03075943|"~     The overall goal of this study is to investigate the effects of a daily dietary supplement of~     brown seaweed (2 capsules of InSea2®) on body weight, glycemic control and insulin secretion~     in overweight prediabetic men and women in association with a moderate weight loss~     intervention.~   "
37488|NCT03075930|"~     This is a single centre prospective data registry. In this study atrial conduction~     characteristics of extended surface Electrocardiograms (esECG), biomarkers and genetic~     analysis will be performed before ablation, before discharge and 3 months after catheter~     ablation of atrial fibrillation (AF) and compared to routine clinical follow-up data.~      The objective of this registry is to establish a data registry of patients undergoing~     ablation of AF. Supplementary to the routine clinical diagnostic an esECG and an analysis of~     biomarkers will be performed and compared to clinical and outcome data.~   "
37489|NCT03075917|"~     Allergic rhinitis is a common condition that affects adults as well as children and~     adolescents, often with impaired quality of life. Patients often report a poor level of~     satisfaction with the effectiveness of their treatment and are always looking for more drug~     combinations to improve their symptom. Several tools exist for assessing control of allergic~     rhinitis, but none has been validated in teenagers or in children. A study conducted in 2008,~     resulted in the validation of a self-administered control test of allergic rhinitis (ARCT) in~     patients from 12 years of age. We propose to adapt ARCT adult to pediatric population from 5~     to 11 years old.~   "
37490|NCT03075904|"~     This study is being conducted to evaluate the safety, tolerability, pharmacokinetics (PK),~     pharmacodynamics (PD), immunogenicity, and effects on pemphigus disease activity markers of~     intravenous (IV) SYNT001.~   "
37491|NCT03075891|"~     The main objective of this study is to evaluate the efficacy of Ivermectin 1% topical cream~     associated with Doxycycline 40 mg Modified release (MR) capsules versus Ivermectin 1% topical~     cream associated with Placebo in the treatment of severe Rosacea.~   "
37492|NCT03075878|"~     This study is being conducted to evaluate the safety, tolerability, pharmacokinetics (PK),~     pharmacodynamics (PD), immunogenicity, and effects on warm autoimmune hemolytic anemia~     (WAIHA) disease activity markers of intravenous (IV) SYNT001.~   "
37493|NCT03075865|"~     OmniMax MMF system was designed as a device with faster application/removal time, less~     mucosal tissue overgrowth over the plates and screws, better tolerance for placement over~     prolong periods of time, better patient hygiene and a lower risk for further treatments~     secondary to root damage from the insertion of the screws, compared to the standard of care~     for maxillo-mandibular fixation and other hybrid systems. This clinical trial intends to~     highlight the clinical benefits of the OmniMax MMF system applied to patients undergoing~     repair of uncomplicated mandibular fracture(s) for whom OmniMax MMF system is used as a~     single mean for maxillo-mandibular fixation.~   "
37494|NCT03075852|"~     Prospective, cross-sectional, observational study investigating a three dimensional heads up~     display for retinal surgery and comparing its outcomes and ease of use with the standard~     operative microscope.~   "
37495|NCT03075839|"~     This pilot study will investigate within-person changes in smoking behavior when current~     adult smokers are systematically switched from smoking menthol cigarettes to non-menthol~     cigarettes.~   "
37496|NCT03075826|"~     -  This is an open label single-arm, single-institution stud to evaluate the efficacy and~          safety of SGI-110 in Philadelphia chromosome negative (Ph-) Myeloproliferative Neoplasms~          (MPN) (excluding PV, ET and primary/secondary myelofibrosis). The study will enroll~          approximately 50 patients at the Weill Cornell Medical College.~        -  Enrollment onto this clinical study is expected to be completed in approximately 36~          months. The total study duration will depend on individual response, evidence of disease~          progression and tolerance. Participants will be followed monthly for six months after~          removal from study or until death, whichever occurs first.~      Key eligibility:~        -  Confirmed diagnosis of Ph- MPN and had~        -  No chemotherapy or radiation treatment within 2 weeks prior to study entry.~        -  Subjects meet other protocol-defined criteria related to baseline screening procedures.~   "
37519|NCT03075527|"~     This research study is studying a pair of immunotherapies as a possible treatment for~     malignant pleural mesothelioma.~      The drugs involved in this study are:~        -  Durvalumab~        -  Tremelimumab~   "
37497|NCT03075813|"~     The purpose of this quality improvement study is to measure the effectiveness of surveillance~     using optimized statistical process control (SPC) methods and feedback on rates of surgical~     site infection (SSI) compared to traditional surveillance and feedback.~      The primary objective is to determine if hospital clusters randomized to receive feedback~     from optimized SPC surveillance methods collectively have lower rates of SSI compared to~     hospital clusters randomized to receiving feedback from traditional surveillance methods.~     Secondary objectives are 1) to estimate and compare the number of signals identified using~     optimized SPC methods and traditional surveillance methods; 2) to estimate and compare the~     time and effort required to investigate signals generated using optimized SPC methods and~     traditional surveillance methods; and 3) to estimate the number and proportion of~     false-positive signals identified using optimized SPC methods and traditional surveillance~     methods.~      The Early 2RIS study will be a prospective, multicenter cluster randomized controlled trial~     using stepped wedge design. The active component of the quality improvement study will be~     performed in 29 DICON hospitals over three years, from March 2017 through February 2020.~     Clusters randomized to intervention will receive feedback on increasing rates of SSI~     identified through optimized SPC methods. This intervention is expected to decrease the~     subsequent rate of SSIs by closing the feedback loop on SSI outcomes.~      Participating study hospitals will all be members of DICON, a network of 43 community~     hospitals in North Carolina, South Carolina, Georgia, Florida, and Virginia that provides~     community hospitals access to consultative services from infection prevention experts, data~     analyses and benchmarking, and educational materials designed by faculty from Duke. This~     study is considered part of routine quality improvement measures and a part of previously~     established agreements between DICON and the community hospitals. Data flow and communication~     are outlined in detail in approved protocols determined to be exempt research by the DUHS~     IRB. Briefly, existing clinical data are extracted from participating hospitals' electronic~     medical record into discrete files according to DICON specifications. Then a~     de-identification process removes direct patient identifiers into a limited dataset.~      The majority of data collection will occur through methods already developed and utilized by~     study hospitals. In brief, each hospital routinely submits limited datasets to the DICON~     Surgical Surveillance Database, including the following variables: hospital, type of~     procedure, patient identifier, date of procedure, age, sex, surgeon identifier, start/stop~     times, ASA score, wound class, risk index, SSI (Yes/No), date of infection, type of SSI,~     location at diagnosis and organism. No identifiable patient or surgeon data are transmitted~     to the DICON Surgical Database. Data definitions and data collection methods are standardized~     across DICON hospitals. Following signal adjudication, additional data will be collected in a~     REDCap database to document actions and rationale.~   "
37498|NCT03075800|"~     Integrating Illness Management and Recovery (IMR) into Assertive Community Treatment (ACT)~     has great promise for improving the symptomatic, functional, and recovery outcomes for people~     with Serious Mental Illness (SMI), especially those individuals who have the greatest needs.~     In addition to these positive consumer outcomes, system benefits may also accrue due to more~     rapid graduation of consumers from ACT (with IMR) programs to less intensive levels of care.~     However, before these benefits can be realized, research and development are needed to design~     and pilot test a treatment manual that is feasible and acceptable to consumers and staff for~     integrating IMR and ACT.~   "
37499|NCT03075787|"~     Obstructive sleep apnea is often associated with microarousals and a stimulation of the~     sympathetic nervous system. The knowledge of this autonomic activation may help understanding~     the increase of cardiac risk observed in elderly. The aim of the study is to evaluate the~     relationship between obstructive sleep apnea severity, age, gender and heart rate response~     associated with obstructive sleep apnea. Drug-free patients diagnosed with obstructive sleep~     apneas were included. Clinical data and 24-h polysomnography recordings were analyzed.~   "
37500|NCT03075774|"~     Multicenter prospective observational study, involving all adult patients who underwent~     cardiac surgery with extracorporeal circulation~   "
37501|NCT03075761|"~     'The PACT trial' is randomized pilot trial to demonstrate the feasibility and potential~     effectiveness of a personal fitness tracker to improve adherence to an activity regimen~     following an initial acute DVT in children.~   "
37502|NCT03075748|"~     The outcomes from prior clinical evaluation of the study device, including successfully~     treating 99% (84/85) of the intended target vessels and 96% (27/28) limb patency observed at~     one year, demonstrate the potential benefits of the device. When contrasted with open~     repair's significant complication rates and branch fenestrated device's significant anatomic~     and logistic limitations, the potential risk of the proposed novel graft does not outweigh~     the potential benefit of widened anatomic availability and improved patency rates. Given the~     potential benefits, the investigators feel that it is justified to expose the target patient~     population to the potential risk. The non-clinical testing performed by Medtronic and the~     clinical results reported by Sanford Health show adequate safety of the device to support an~     early feasibility study.~      The investigators would like to perform an early feasibility study under a defined and~     controlled protocol to collect prospective preliminary safety and device functionality data.~     The investigators believe an early feasibility study is most appropriate for this novel~     approach. The limited sample size allows adequate patient data to be collected under a~     controlled protocol without exposing a large patient population to the risk associated with a~     novel device design.~   "
37503|NCT03075735|"~     PROREPAIR is a prospective multicenter observational cohort study of unselected patients with~     metastatic Castration Resistant Prostate Cancer (mCRPC) with unknown germline mutational~     status at study entry and who are candidates to start 1st line treatment with any approved~     survival-prolonging agent.~      The study aims to evaluate the impact of aberrations in DNA-repair genes,(BRCA1, BRCA2, ATM~     and PALB2 and other genes) on cause-specific survival from the diagnosis of the metastatic~     castration resistant status and other outcomes.~   "
37504|NCT03075722|"~     This investigation is designed to evaluate the performance (treatment and leak), comfort~     (subjective feedback), stability (subjective feedback, leak) as well as the participant's~     overall acceptance of the Saturn mask amongst OSA participants. An important factor in this~     investigation will be the testing of our two different seal sizes on the participants (small~     and medium size). A total number of 15 participants who currently use nasal or nasal pillow~     masks will be recruited for the trial. A subset of participants have been selected based on~     their anthropometric measurements collected in previous trials using nasal and nasal pillow~     masks at this site (CIA-103). Participants from previous NZ trials may be recruited into this~     trial with their consent. All the participants will be recruited by WellSleep, Wellington.~      Participants will use the trial mask in home for a period of 7 ± 3 days. Baseline data will~     be collected from the participant during the first visit, the prior 7 days of CPAP usage data~     will be downloaded and stored for our analysis. The participant will use the trial device on~     their usual CPAP/APAP setting and device for the duration of the trial.~      This study will be conducted in accordance with ICH/GCP guidelines. No deviation from the~     protocol will be implemented without prior review and approval of the sponsor except where it~     may be necessary to eliminate an immediate hazard to a research participant. In such case,~     the deviation will be reported to the sponsor as soon as possible.~   "
37575|NCT03074799|"~     To assess implementation of a nurse-led, symptom-based screening program in local,~     decentralized clinics for tuberculosis (TB) screening of child contacts less than 5 years old~     who were exposed to tuberculosis in the home. This will allow nurses in decentralized clinics~     to either start IPT for those asymptomatic patients and refer symptomatic patients for~     evaluation of TB disease and possible antituberculous therapy (ATT).~   "
37505|NCT03075709|"~     Chronic obstructive pulmonary disease (COPD) has substantial economic and human costs. To~     minimize these costs high quality guidelines have been developed. However, development of~     guidelines alone rarely results in changes to practice. One method of integrating guidelines~     into professional practice is the use of clinical pathways (CPWs).~      The investigators are working with local stakeholders to develop CPWs for COPD with the aims~     of improving quality of care and guideline adherence while reducing healthcare utilization.~     The CPWs will utilize several steps including: standardizing diagnostic training,~     implementing and unifying common components of chronic disease care, coordinating the~     provision of education and reconditioning programs, and ensuring disease specific care~     utilizes and delivers evidence-informed practices. In addition, the investigators have worked~     to identify evidence-informed strategies for the implementation of the CPWs. Efforts are~     underway to tailor these implementation strategies for the local context.~      The investigators will conduct a three-year quantitative health services research project~     using an interrupted time series (ITS) design in the form of a multiple baseline approach~     with control groups. The CPW will be implemented in two Saskatchewan health regions~     (experimental groups) and two health regions will act as controls (control groups). The~     experimental and control groups will each contain one urban and one rural health region.~      This project is expected to improve quality of life and reduce healthcare utilization. The~     project will also provide evidence on the effects of CPWs in both urban and rural settings.~     If the pathways are found effective the investigators will work with all stakeholders to~     implement similar CPWs for the remaining health regions in the province.~   "
37506|NCT03075696|"~     This is a Phase I, multicenter, open-label, dose-escalation study designed to evaluate the~     safety, tolerability and pharmacokinetics (PK) of a novel T-Cell bispecific (TCB), RO7082859,~     administered by intravenous (IV) infusion, following the pretreatment administration of a~     one-time, fixed dose of obinutuzumab. The study is divided in 3 parts: dose escalation (Parts~     I and II) and dose expansion (Part III). Single-participant dose-escalation cohorts will be~     used in Part I, followed by conversion to multiple participant dose-escalation cohorts (Part~     II), in order to define a tentative maximum tolerated dose (MTD) or optimal biological dose~     (OBD). The expansion cohorts (Part III) will be initiated when the tentative MTD/OBD is~     defined, to further evaluate the safety, PK and therapeutic activity of RO7082859.~   "
37507|NCT03075683|"~     The main goal is to study the effect of therapist-guided internet-delivered cognitive~     behavioural therapy for insomni comorbid with chronic pain in a clinical sample.~   "
37508|NCT03075670|"~     This trial is conducted in Europe and the United States of America. The aim of this trial is~     to compare the pharmacokinetics (the exposure of the trial drug in the body) of nonacog beta~     pegol (N9-GP) and ALPROLIX® in patients with haemophilia B.~   "
37509|NCT03075657|"~     The proposed study has been planned to evaluate the effect of add-on ramelteon on sleep~     pattern/quality and circadian rhythm disruption in patients with schizophrenia.~   "
37510|NCT03075644|"~     This trial is conducted in Asia. The aim of this trial is to evaluate the safety of once~     weekly dosing of somapacitan (NNC0195-0092) and daily Norditropin® FlexPro® for 52 weeks in~     previously human growth hormone treated Japanese adults with growth hormone deficiency.~   "
37511|NCT03075631|"~     This study is an ancillary of APPRENTICE. This will be the international based study.~   "
37512|NCT03075618|"~     The management of acute pancreatitis is mainly based on expert opinions; large randomized~     controlled trials are missing and novel therapeutic approaches are considered necessary. This~     study will evaluate the current management and outcomes of acute pancreatitis around the~     world.~   "
37513|NCT03075605|"~     This is a prospective case control study that compares the initial immune response with~     severity and outcome in patients with acute pancreatitis.~   "
37514|NCT03075592|"~     This study plans to directly address the problem of post-ERCP pancreatitis to gauge the~     various factors involved in its development and genetic variability in the immune response to~     an isolated pancreatic insult. In addition, the investigators hope to study markers of the~     early immune response to this injury and to develop a risk-assessment model.~   "
37515|NCT03075579|"~     Diurnal profiles of markers of the stress system are increasingly recognized as biomarkers of~     different kinds of depression and related states. They may also serve as markers of treatment~     success. However, this has not yet been studied in attention deficit disorder (ADHD).~     Especially, there is a paucity of research into the effect of ADHD medication on the diurnal~     profiles of cortisol as marker of the hypothalamic pituitary adrenal (HPA) system and of~     amylase as marker of the sympathetic adrenomedullar (SAM) system.~      The investigators propose a within subjects design with probands of a narrow age range (seven~     to ten years of age, same sex: boys only) in order to get first information about whether~     there is an effect of atomoxetine on these diurnal profiles of cortisol and amylase, what~     kind of effect it is and whether this effect is related to treatment success. The~     investigators control for motor activity by using actometer measurements.~   "
37516|NCT03075566|"~     Atherosclerosis is a chronic inflammatory condition, which is associated by the involvement~     of several pathological events, and alteration in the serum levels of pro- and~     anti-inflammatory, and lipid markers.~      The investigators evaluated the contribution of serum biomarkers levels to the pathogenesis~     of coronary artery disease, namely their association with risk factors, clinical~     presentation, extent and severity of atherosclerotic changes accompanying coronary artery~     disease.~   "
37517|NCT03075553|"~     This phase II trial studies how well nivolumab works in treating patients with peripheral~     T-cell lymphoma that has come back after a period of improvement or that does not respond to~     treatment. Monoclonal antibodies, such as nivolumab, may block cancer growth in different~     ways by targeting certain cells.~   "
37518|NCT03075540|"~     Compared to non-Latina Whites, Latinas have a higher prevalence of BRCA1/2 gene mutations but~     lower use of genetic cancer risk assessments services (GCRA). This study will develop and~     assess the impact of a novel culturally targeted media intervention to improve psychosocial~     outcomes and GCRA use in Latinas at-risk of hereditary breast and ovarian cancer. If the~     intervention is proven to be effective in a future randomized controlled trial, the~     intervention can be disseminated to clinics and adapted to other ethnic groups.~   "
37520|NCT03075514|"~     Glioblastoma (GB) is the commonest form of brain cancer in adults. Despite current treatment~     options including surgery, radiotherapy and chemotherapy, overall survival is poor.~     Therefore, other treatment options are being explored and there is increasing interest in the~     possibility of using the ketogenic diet (KD), alongside current treatment options.~      The KD is a high fat, low carbohydrate diet. This encourages the body to use fat (broken down~     to ketones) as its primary energy source, instead of carbohydrate (broken down to glucose, a~     type of sugar). KDs have been considered for use in patients with GB as this type of cancer~     is thought to use glucose as its main energy supply, which is of short supply in this diet.~     Animal studies have shown KDs may make GB more responsive to radiotherapy and chemotherapy~     and could improve survival by slowing the cancer's growth. However, clinical studies are~     needed in humans to assess any possible benefits.~      This trial will see patients randomly assigned to one of two types of KDs; the modified~     ketogenic diet (MKD) and the medium chain triglyceride ketogenic diet (MCT). Both diets~     follow the same high fat, low carbohydrate principles, with the MCT diet requiring the~     patient to take some of the fat as a supplement drink instead of as food. Patients will~     follow the diet for 12 weeks initially. The trial will look to enroll newly diagnosed GB~     patients, from The Walton Centre NHS Foundation Trust over a 12 month period.~      The aim of the trial is to investigate protocol feasibility and patient impact by comparing~     two KDs in an NHS setting, with a view to informing future phase III clinical trials.~   "
37521|NCT03075501|"~     The purpose of the study is to determine how associations between drugs and the places where~     they are experienced influence drug seeking, mood and acute drug responses.~   "
37522|NCT03075488|"~     The study is aimed at evaluating whether ultrasound pre-procedural scan with Accuro may~     reduce needle redirections when performing spinal injection in patients with BMI = or > 30 in~     orthopedic surgery~   "
37523|NCT03075475|"~     This randomized controlled trial evaluates the effectiveness of a psychotherapeutic~     intervention, the Common Elements Treatment Approach (CETA), to address the mental health~     needs of children and adolescents age 8-17 who have been affected by armed conflict in Kachin~     State, Myanmar. The 10-12 week talk-based counseling treatment, delivered by community mental~     health workers, will be evaluated against a wait-list control group. This project follows on~     a recently completed trial of CETA for adult trauma survivors from Myanmar along the~     Thai-Myanmar border which found that CETA was acceptable, accessible, and effective in~     improving mental health and functioning of adults. The investigators hypothesize that the~     intervention will be similarly effective for improving the mental health and functioning of~     children and adolescents.~   "
37524|NCT03075462|"~     Fluzoparib is an oral potent, selective poly-ADP ribose polymerase-1 (PARP-1) and PARP-2~     inhibitor; Apatinib is an oral selective vascular endothelial growth factor receptor (VEGFR)~     inhibitor. This open-label, dose finding phase I trial studies the tolerability and the best~     dose of fluzoparib in combination with apatinib and to see how well these two drugs work~     together in the treatment of patients with recurrent ovarian cancer or triple negative breast~     cancer. The safety and efficacy of fluzoparib in combination with apatinib will be explored.~     Both dose escalation and dose expansion parts are included in this study.~   "
37525|NCT03075449|"~     This study will describe the current medical care given to men who discuss their lower~     urinary tract symptoms with a HCP. It will document the primary reasons for the visit, the~     baseline characteristics of these men, the treatment received, and the practice patterns of~     specifically a primary care physician managing these patients.~   "
37526|NCT03075436|"~     This study is a two-year evaluation investigating the impacts of an enhanced, demand-side~     sanitation and hygiene intervention on sustainable adoption of improved water, sanitation,~     and hygiene (WASH) practices and mental well-being.~   "
37527|NCT03075423|"~     SUNNIFORECAST (Sunitinib vs. Nivolumab + Ipilimumab as First line treatment Of REnal cell~     CAncer of non-clear cell SubTypes) is a Phase II, randomized, open-label investigator~     initiated trial (IIT) of Nivolumab (BMS-936558) combined with Ipilimumab vs standard of care~     in subjects with previously untreated and advanced (unresectable or metastatic) non-clear~     cell renal cell carcinoma (nccRCC).~   "
37528|NCT03075410|"~     GSK3036656 is being developed by GSK for the treatment of tuberculosis (TB). This is the FTIH~     study for GSK3036656 to evaluate the safety, tolerability and PK of single ascending and~     repeat oral doses of GSK3036656 in healthy adult subjects. The results of this study are~     intended to be used to identify appropriate and well-tolerated doses of GSK3036656 to be used~     in further studies. A food effect assessment will also be undertaken to investigate the~     influence of food on the PK of GSK3036656. The study will be conducted in two parts: Part A~     (single dose) and Part B (repeat dose). Up to two cohorts will be included in Part A. 9~     healthy adult subjects will be included in each cohort. Each cohort will participate in up to~     4 treatment (dosing) periods including a food effect treatment period. During each treatment~     period, GSK3036656 will be administered to 6 subjects and placebo will be administered to 3~     subjects. The starting dose in Part A will be 5 milligrams (mg), and the maximum dose will be~     1500 mg. The two cohorts in Part A will be dosed sequentially (i.e., dosing in Cohort 2~     starts after dosing in Cohort 1 is completed). Initially, there will be a 14 day wash out~     period for individual subjects between each dose level. Study progression to Part B from Part~     A will be based on an acceptable safety, tolerability and PK profile in Part A. Part B will~     comprise up to 4 cohorts (Cohorts 3, 4, 5, and 6) each containing 10 (8 active: 2 placebo)~     healthy adult subjects to examine the safety, tolerability and PK of a repeated daily dose of~     GSK3036656 over a period of up to 14 days. Appropriate doses and dose regimens for Part B~     will be selected based on available safety, tolerability and PK data from Part A and/or any~     preceding repeat dose cohorts from Part B. Dividing the total daily dose into 2 or 3 smaller~     doses may be done in both Part A and Part B. Up to 18 subjects will be enrolled into Part A~     and up to 40 subjects will be enrolled into Part B. The total duration of the study for each~     subject recruited into Part A and Part B will be approximately 12 weeks and 8 weeks,~     respectively.~   "
37529|NCT03075397|"~     The objective of our project is to determine the infected seminal cell types and the~     molecular mechanisms involved in HIV cell-associated transmission in the colo-rectal mucosa,~     using conditions as close as possible to real life, i.e. seminal leukocytes and seminal~     plasma from HIV-infected donors and tissue explants~   "
37530|NCT03075384|"~     Many studies show that computer-assisted navigation system have been available to treat~     zygomatic-complex fractures. However, most of them are case reports or clinical experiences~     lacking multiple variables and controlled design. The aim of this study was to evaluate the~     accuracy of the computer-assisted navigation system by a randomized controlled trial with~     multiple variables.~   "
37531|NCT03075371|"~     The goal of the present study is to investigate metabolic gut-brain signaling and the neural~     correlates of distraction from visual food cues in patients with Anorexia nervosa and healthy~     controls.~   "
37584|NCT03074682|"~     The aim of the study is to determine if a new device is more effective in fluid~     administration than devices currently used when resuscitating pediatric patients in septic~     shock. This study will take place in a simulation lab setting and will not include the use of~     patients.~   "
37532|NCT03075358|"~     Endometrial aspiration biopsy has been accepted as a diagnostic procedure of choice for women~     with abnormal uterine bleeding to examine endometrial pathology. The procedure has high~     accuracy comparing to conventional fractional curettage. However, it is associated with~     significant pain during the procedure. In general, there is no specific recommendation~     regarding the proper anesthesia used during the procedure.~      The aim of this study is to examine the effect of lidocaine spray for reducing pain during~     the endometrial aspiration procedure by comparing it with placebo and no intervention.~   "
37533|NCT03075345|"~     Obesity is an 'epidemic' within the UK. Individuals living with obseity are at risk of~     developing cancer, heart problems and dieing. Furthermore, obesity impacts on psychological~     wellbeing via lowered self-efficacy, self-esteem, body image and overall quality of life~     (QoL). A pilot randomised controlled trial (RCT) is proposed to investigate the additional~     benefit of a psychological intervention alongside treatment as usual (TAU) in a weight~     management service. Patients routinely attending an outpatient clinic will be randomised into~     TAU with or without additional acceptance and commitment Therapy (ACT) group based-input and~     their outcomes monitored over time.~   "
37534|NCT03075332|"~     The goal of this study was to evaluate the effect of detraining in the components of physical~     aptitude of people living with HIV/Aids (PVHA).~   "
37535|NCT03075319|"~     Total knee arthroplasty (TKA) is recognized as a successful procedure for treating~     osteoarthritis (OA) of the knee. One important factor that make the successful surgery is the~     degree of knee flexion. Providing more range of motion after TKA impact on the convenience of~     daily of life such as climbing stairs, sitting on the floor particularly in Asian cultures~     which require a lot of ground activities. Data are limited on the added benefits of~     perioperative photograph as motivation for increasing range of motion after TKA.~      Half of participants received perioperative photograph as motivation, while the other half~     did not after total knee arthroplasty.~   "
37536|NCT03075306|"~     The prevalence of overweight and obesity in youth with serious emotional disturbance (SED)~     exceeds the epidemic levels of overweight and obesity for children in the general population.~     Associated cardiovascular (CVD) risk factors such as glucose intolerance, hypertension and~     lipid abnormalities frequently already exist in obese children. Thus, focusing on~     overweight/obesity in youth with SED is critical to prevent their premature CVD. In 2015 the~     American Heart Association called attention to mental illnesses in youth as important risk~     conditions for early CVD and declared the need for transformational change in screening and~     management of overweight and obesity. Despite this, studies of healthy weight interventions~     in youth with SED are noticeably absent, and interventions will likely need to be tailored~     for this population who frequently have impulsivity, oppositional behavior and/or mood~     symptoms. In the general population, successful interventions targeting youth obesity often~     include active parental participation. Community mental health programs serving youth~     typically engage parents as part of routine treatment and therefore provide an unappreciated~     but potentially important opportunity to address overweight and obesity. The objective of~     this study is to design and rigorously test an innovative, scalable healthy weight~     intervention in youth with SED that incorporates parental engagement and provider support.~     The CHAMPION Trial is a two-arm trial partnering with community mental health organizations~     in Maryland. We will perform population-based screening to identify youth with overweight and~     obesity, and recruit and enroll 120 ages 8-18 years with SED with a BMI at or above the~     85th%tile. The study will stratify by sex and site and randomly assign participants to~     receive a) usual care plus educational materials on healthy weight, or b) the 12-month~     CHAMPION intervention with 1) a health coach, a trained mental health program employee, who~     provides healthy lifestyle counseling and support for weight management, a healthy diet and~     increased physical activity incorporating techniques to engage both the youth and parents;~     and 2) support from health providers who will provide basic weight management messages and~     encouragement for behavior change. The intervention's first 6 months will include frequent~     contacts, followed by a 6-month maintenance phase. The primary outcome will be decreased BMI~     z-score compared to control at 12 months; secondary outcomes include waist circumference,~     blood pressure, glucose, lipid levels, quality of life, and psychiatric symptoms at 6 and 12~     mo. Antecedents of CVD begin early in youth, and those with SED are at particularly high~     risk. Breaking this cascade of risk factors leading to premature CVD will require~     capitalizing on the window of opportunity to intervene on overweight and obesity in youth~     with SED. The CHAMPION Trial will test an innovative, yet practical approach that could be~     readily incorporated into overall care of youth with SED.~   "
37537|NCT03075293|"~     The aim of this retrospective study is to determine the percentage of children with~     appendicitis who were given analgesics or opioids in the ER, to reduce their pain.~   "
37538|NCT03075280|"~     To test the benefits of extra high carbohydrate liquid diet uptake 2 hours before ERCP in~     improving patients' early recovery.~   "
37539|NCT03075267|"~     A study to assess the pharmacokinetics and safety of two doses of PT010 and a single dose of~     PT003 in healthy Chinese adult subjects~   "
37540|NCT03075254|"~     Chronic pain and fatigue are characterized by peripheral and central mechanisms including low~     pain thresholds, temporal summation, peripheral and central sensitization. This application~     will focus on central factors of chronic pain and fatigue. Functional brain imaging will be~     used to characterized brain and spinal cord abnormalities that contribute to the mechanisms~     of these disorders.~   "
37541|NCT03075241|"~     The purpose of this study is to determine whether Zolpidem and Zoplicone are efective in the~     treatment of sleep disorders in Alzheimer's disease (AD)~   "
37542|NCT03075228|"~     Rationale: The microbial composition in the small intestine (SI) differs largely from the~     composition in feces. Many physiological processes related to health, such as~     immunoregulation and metabolic programming, mainly take place in the SI. Therefore, the SI,~     from a microbiota perspective, is as relevant as the large intestine. There are indications~     that microbiota composition is different in lean and obese subjects, and is related to~     insulin resistance. However, these indications are mainly based on the analysis of fecal~     samples. Therefore, analysis of the microbiota composition in the more proximal part of the~     gastrointestinal (GI) tract may provide new insights into the microbial species that are~     involved or related to metabolic homeostasis at that location. The IntelliCap® CR system~     offers a minimally invasive tool that is able to collect reliable samples in the SI, as was~     shown by NIZO in a clinical validation study. The main aim of the current study is to explore~     and compare the upper GI microbiota composition in lean and obese subjects, in order to~     generate new leads for development of products that may target the upper GI microbiota~     community or specific species thereof, which may impact the maintenance of metabolic~     homeostasis. This may provide new opportunities for the treatment, reduction or prevention of~     overweight and/or obesity or insulin resistance.~   "
37543|NCT03075215|"~     To learn in a general Cardiac Resynchronization Therapy Defibrillators (CRT-D) population,~     which optimization techniques are used and how effective they are. It will compare 12-month~     response rates among different optimization methods and characterize which selected subject~     subgroups achieve better response than others.~      A subset of SMART Registry subjects will contribute to the NG4 Post Market Clinical Follow Up~     (PMCF) Cohort whose objective is collecting data on the NG4 CRT-D features and device usage~     in a real world setting and monitor long term safety associated with these devices to support~     CE Mark.~   "
37544|NCT03075202|"~     It is well established in the scientific literature that people with schizophrenia smoke~     tobacco cigarettes at rates up to three times that of the general population, relapse more~     frequently, and die an average of 25 years earlier from cigarette smoking and other~     life-style attributable illnesses. Electronic cigarettes (e-cigarettes) are becoming~     increasingly popular with smokers worldwide and new research suggests that e-cigarettes are~     appealing to smokers with schizophrenia. There is a paucity of research focused on the~     experience of smokers with schizophrenia who decide to try an e-cigarette. A well-designed~     prospective-observational study is needed to learn more about the influence of e-cigarette~     use on cigarette smoking behavior and mental and physical health among smokers with~     schizophrenia. In response, the investigators have designed a study titled, Role of an~     electronic cigarette on smoking displacement in smokers with schizophrenia: A prospective~     3-month pilot study (SchizEcig).~   "
37571|NCT03074851|"~     Mass media plays more and more important role in health education, especially in some chronic~     diseases which related closely with the behavior and habits. Past experience tells us that~     with the help of related health education in mass media such as newspaper articles,~     advertisements and videos on television, peoples can change their behaviors and habits in a~     short period of time. But when these educational information were stopped, peoples usually~     return to their original habits. Besides the national policy of the country how to improve~     the long-term health education in the mass media should be considered.This study hopes to~     seek an effective method to keep the mass media long-term focus on health education.~   "
37545|NCT03075189|"~     Up to approximately 38 (unknown drop-out rate) geriatric patients (at least 65 years old) are~     recruited from a Geriatric ward at Slagelse Sygehus. After inclusion and baseline~     measurements, each individual will be randomized into either an intervention or control group~     arranged in blocks of 8 The intervention group (n≤19) will receive protein enriched~     snacks/dishes in the morning and late evening, before bedtime. Moreover, upon discharge the~     intervention group will receive individual dietary counseling focusing on choosing~     protein-rich foods and on protein rich meals. The control group (n≤19) will receive normal~     hospital food without enrichment and no dietary counseling at discharge. In both groups the~     following data will be obtained: recorded protein intake, anthropometric measurements~     (weight, height, body composition estimated with bioimpedance), functional ability (De Morton~     Mobility Index (DEMMI) and Barthels ADL-index), hand grip strength, sarkopenic status~     (SARC-F), quality of life (EQ-5D-3L), length of stay (LOS) and readmissions (within 30 days~     after discharge). During hospitalization food intake will be registered, as well as 24 hour~     recall interviews and food frequency questionnaires will be done at follow-up visits.~      Assessments will be performed at baseline, on the day of discharge and 4 weeks after~     discharge (follow up).~      The primary outcome is change in protein intake from Baseline to 4 weeks after discharge.~      The hypothesis is that serving of individually selected protein enriched snack/dish in the~     morning and before bedtime during hospitalization results in higher protein intake during~     hospitalization and that this experience combined with dietary counseling at discharge,~     results in a higher protein intake at 28 days after discharge. Further, we hypothesize that~     the increased protein intake will affect functional level, hand grip strength, sarcopenic~     status and quality of life in geriatric patients and will lead to shorter LOS and fewer~     readmission frequency.~   "
37546|NCT03075176|"~     This study evaluates the difference in results between eyes that have been treated wavefront~     optimized laser vision correction (either LASIK or Photorefractive Keratectomy) compared to~     eyes treated with topography-guided laser vision correction (either LASIK or Photorefractive~     Keratectomy). Each participant will receive wavefront optimized correction in one eye and~     topography-guided correction in the other.~   "
37547|NCT03075163|"~     This is a single site, prospective, randomized controlled study designed to evaluate the~     impact of acupressure when used as an initial treatment before rescue medications in the~     treatment of post-operative nausea and/or vomiting at UCD.~   "
37548|NCT03075150|"~     This is a prospective, randomized, sequential data collection study to evaluate the ability~     of pleth variability index (PVI) to predict fluid responsiveness in comparison with other~     dynamic parameters including pulse pressure variation (PPV) and stroke volume variation~     (SVV).~   "
37549|NCT03075137|"~     Stroke is a prevalent atherosclerosis vascular disease with high mortality, external counter~     pulsation (ECP) is an approved noninvasive therapy for angina, congestive heart failure,~     myocardial infarction, and cardiogenic shock that augments blood flow to cardiac and systemic~     circuits, which improves the flow volume in the carotid. Though ECP is Ⅱa recommendation for~     stroke management, no multi-center control clinical study has been reported for prognosis of~     stroke. The aim of this study is to evaluate the effect of ECP on stoke. To address this~     assumption, investigators enroll subjects with ischemic stroke and randomized into control or~     ECP group, the ECP intervention will be carried out with a standard protocol which involves~     35 one-hour sessions (5 days a week) for continuous 7 weeks. The primary endpoint is mRS~     score in 3 months, secondary endpoints include NIHSS, BI and MMSE score, recurrence of stroke~     in 3 months, glycolipid metabolism, transcranial doppler (TCD) flow velocities and~     endothelial function.~   "
37550|NCT03075124|"~     Coronary artery disease (CAD) is prevalent worldwide and the leading cause of mortality of~     citizens, external counter pulsation (ECP) has been elucidated that it may release angina~     symptoms and improve the prognosis of CAD, however, no multi-center control clinical study~     has been reported for further recommendation. The aim of this study is to evaluate the effect~     of ECP on CAD. To address this assumption, investigators enroll participants with stable CAD~     and randomize them into control or ECP group, the ECP intervention will be carried out with a~     standard protocol which involves 35 one-hour sessions (5 days a week) for continuous 7 weeks,~     and the follow-up will last for 1 year. The primary endpoint is the 1-year composite~     cardiovascular events (CCE), secondary endpoints include frequency of angina pectoris, heart~     function, biomarkers of arteriosclerosis, exercise tolerance and endothelial function.~   "
37551|NCT03075111|"~     This is a retrospective external field study of a novel in vitro diagnostic (IVD) assay~     (ImmunoXpert™).~      The study will involve reviewing the medical charts of 4500 pediatric patients that were~     tested using ImmunoXpert™ as part of the routine workup for acute febrile illness.~      ImmunoXpert™ uses a computer algorithm to combine immunoassay measurements of three host~     immune proteins (TRAIL, IP-10, and CRP) present in human blood. The test is intended for use~     in conjunction with clinical assessments and other laboratory findings as an aid to~     differentiate bacterial from viral infection.~      Statistical analysis will be performed to compare the diagnostic accuracy of ImmunoXpert™~     with that of current practice lab testing e.g., WBC, CRP, and PCT (whichever were taken as~     part of routine care) and clinical suspicion at time of requisition.~   "
37552|NCT03075098|"~     The aim of this work is to detect the diagnostic accuracy of the intra-oral application of~     colposcope in diagnosing oral dysplastic lesions in comparison to biopsy taking and~     histopathological examination.~   "
37553|NCT03075085|"~     Investigators will pilot test the impact of an enhanced implementation strategy on~     implementation and child health outcomes using continuous formative evaluation. Investigators~     will test the hypothesis that better fidelity to the implementation strategy (WISE) is~     positively related to child outcomes (e.g., child fruit and vegetable intake, BMI).~   "
37554|NCT03075072|"~     This research study is studying two different types of radiation as treatment for brain~     metastases (tumors in the brain that spread from a cancer that originated elsewhere in the~     body)~   "
37555|NCT03075059|"~     1. Determine preoperative and postoperative levels of anxiety for pediatric patients ages~          6-17 related to outpatient surgical intervention using the validated Psychosocial Risk~          Assessment in Pediatrics (PRAP) assessment tool, the State-Trait Anxiety Inventory for~          Adults(STAI-AD), and the State-Trait Anxiety Inventory for Children (STAI-CH)~        2. Determine preoperative and postoperative levels of anxiety for parent/guardian of~          pediatric patients ages 6 - 17 related to outpatient surgical intervention using the~          validate PsychosocialRisk Assessment in Pediatrics (PRAP) assessment tool and the~          State-Trait Anxiety Inventory for Adults (STAI-AD).~        3. Assess if additional Child Life intervention offered pre-operatively to one group~          demonstrates differences in PRAP scores compared to control group~   "
37585|NCT03074669|"~     The main objective of this study is to test the effectiveness of an Internet-delivered~     Acceptance and Commitment Therapy (ACT) program in reducing anxiety symptoms.~   "
37556|NCT03075046|"~     Vulvovaginal candidiasis (CVV) is an infectious process of the female genitourinary tract, an~     important health issue due to the high incidence and difficulties encountered in the~     treatment. Therefore, new therapeutic modalities are sought with the capacity to minimize~     drug side-effects and to reduce recurrent cases. The objective of this stufy is to evaluate~     the clinical and microbiological response of the 405 nm blue light emitting diode in the~     treatment of women with vulvovaginal candidiasis and in women with healthy gentourine~     treatment. A clinical trial was conducted involving 40 women, divided into two groups, the~     first group consisting of women with a confirmed CVV diagnosis and a second group formed by~     women with a healthy genitourinary tract, without symptoms and symptoms of the disease. Both~     groups underwent clinical evaluation and examination with endocervice collection with~     gynecologist before and after a session of application of the Blue Light Emitting Diode of~     405 nm, lasting 4.5 minutes. There will also be an evaluation of the effects of the diary~     through the questionnaire answered before and after the participants' treatment. It is~     expected that the 405 nm blue LED will destroy the CVV fungus demonstrated by laboratory~     examination and also improve the signs and results analyzed by the gynecologist and~     participants.~   "
37557|NCT03075033|"~     Background: Conventional intubation of the trachea and consequent prone positioning of~     anaesthetized patients with cervical spine instability may result in secondary neurological~     injury. Historically, the flexible fiber-optics used to be the chief choice for patients~     presenting with cervical spine instability surgery either with normal, predicted difficult~     airway, or even unanticipated difficult airway. Recently, the rigid optical stylets have~     shown promise in assisting difficult intubations.~      Purpose: The aim of the present study was to compare the efficacy of Shikani optical stylet~     (SOS) with the flexible fiberscope for awake intubation in patients with cervical spine~     instability.~      Methods: Sixty adult patients with a neurosurgical diagnosis of cervical instability or at~     risk of secondary cervical injury, who were planned for awake intubation and self-positioning~     prone, were registered in this study and were randomly categorized into two equal groups~     (thirty patients each), a fiberoptic group and a SOS group, then assessment of coughing and~     gagging during and after intubation, time to intubation, number of attempts for successful~     intubation, haemodynamic parameters, careful examination of the oropharynx to determine any~     lip or mucosal trauma, and eventually the motor function by the ability to move arms and legs~     were assessed after tracheal intubation and after positioning prone.~   "
37558|NCT03075020|"~     To investigate headache score and accompanying symptoms during and after inhalation of carbon~     monoxide.~   "
37559|NCT03075007|"~     This study examines the factors that may drive the relationship between vascular disease and~     Alzheimer's Disease (AD) in a large, longitudinal, multi-ethnic community-based cohort study~     of older adults in northern Manhattan, New York. In past research, the investigators~     demonstrated that accumulation of brain vascular disease is associated with risk for~     development of AD. The study now extends the research to examine how brain vascular disease~     and AD interact. In this pilot study, the investigators will obtain positron emission~     tomography (PET) scans to measure amyloid (one of the protein pathological markers of AD)~     from participants in an ongoing community-based study of aging and dementia (WHICAP). The~     study will include subjects who are already enrolled in the parent project and already~     evaluated at baseline with PET scans. The study plans to obtain 20 amyloid PET scans after a~     5-year interval on the cohort of participants established at baseline. The investigators will~     also conduct transcranial Doppler studies to measure blood flow in the participants with~     amyloid PET scans. The potential benefits to society should be considerable if this study~     reveals new information about risk factors for or contributions to AD.~   "
37560|NCT03074994|"~     Post-operative bleeding in total knee arthroplasty (TKA) can result in hypovolemic shock and~     unnecessity for allogenic blood transfusions. Intravenous and topical tranexamic acid (TXA)~     have been well established in reducing blood loss postoperatively. However, there are lack of~     data on peri-articular TXA injection during TKA. Therefore, the investigators conducted a~     three-arm prospective, randomized, controlled trial to compare the effectiveness of bleeding~     reduction of peri-articular TXA injections, intraarticular TXA injections and control group.~   "
37561|NCT03074981|"~     Difficult to heal wounds are a common and complex medical problem, causing suffer to the~     patients and challenging medical, social and economic burden on the health system. Based on~     data from the western world, it is estimated that in Israel, at any given time, 30 to 60~     thousand patients with difficult to heal wounds. Among diabetics patients, it is estimated~     that 15% to 25% will develop a difficult to heal foot wounds during their live time.~      The medical definition of a difficult to heal wounds is: a wound showing no signs of recovery~     after 4-6 weeks of treatment. Most of these wounds are caused by anaerobic bacteria~     inventions.~      One of the methods for the treatment of difficult to heal wounds is - ROI-RNPT (Regulated~     Oxygen -Enriched & Irrigation Negative Pressure -Assisted Wound Therapy).~      This method creates in the wound a negative pressure in the presence of oxygen and irrigation~     applied directly into the wound bed.~      As part of the wound closure process the investigators will use the external tissue~     expansion. This method under clinical use is exercised by the - Top Closure tension~     relief system (TRS).~      In this study, the investigators intend to investigate whether ROI-NPT system combined with~     TopClosure, is effective for the treatment of difficult to heal wounds, compared with methods~     currently in use.~   "
37562|NCT03074968|"~     This study is designed to examine the effect of benzydamine hydrochloride to postoperative~     sore throat in pediatric patients. We will spray benzydmaine hydrochloride or normal saline~     at oral cavity and the tip of endotracheal tube, than compare the prevalence of postoperative~     sore throat using smartphone application in pediatric patients.~   "
37572|NCT03074838|"~     A controlled un-randomized trial where the inflammatory response in 18 patients admitted for~     TAVI procedure is compared to the inflammatory response in 18 patients admitted for~     conventional surgical valve replacement. Clinical outcomes are recorded and compared between~     the Groups. As a secondary endpoint, the inflammatory response was also compared between the~     patients receiving either transfemoral or trans aortal TAVI.~   "
39211|NCT03053427|"~     The objective of this study is to assess the efficacy of once-daily oral administration of~     Gabapentin enacarbil versus placebo, based on the change in International Restless Legs~     Syndrome Rating Scale (IRLS) score in subjects with moderate-to-severe primary Restless Legs~     Syndrome. This study will also assess the safety of Gabapentin enacarbil.~   "
37563|NCT03074955|"~     Although propofol is widely used as an induction agent for a general anesthesia, it can~     induce a profound hypotension, which leads to the hypo-perfusion of end organs and eventually~     increases morbidities. Theoretically, applying Trendelenburg position (head down and leg up~     position) increases cardiac preloads and cardiac outputs. However, in past researches,~     changing to Trendelenburg position alone is not enough and does not prevent propofol induced~     hypotension. Previous studies proved that leg wrapping effectively prevent hypotension after~     neuraxial anesthesia during Cesarean section. The leg wrapping prevents hypotension by~     increasing vascular resistance of lower extremities. The investigators made a hypothesis that~     applying both Trendelenburg position and leg wrapping prevent propofol induced hypotension~     more effectively than either applying Trendelenburg position only or taking no preventive~     measures.~   "
37564|NCT03074942|"~     Approximately, 5% of the patients with asthma suffer a difficult-to-control severe variant of~     the disease. Despite being treated with inhaled corticosteroids (ICs), long-acting~     β2-agonists (LABA), oral corticosteroids or omalizumab, one or more components of the control~     concept (symptoms, exacerbations, bronchial obstruction) remain to be resolved. Omalizumab~     has been proven to safely reduce asthma exacerbations and to decease symptoms and quality of~     life in severe allergic asthmatics. However, approximately 25% of the treated patients fail~     to respond to this monoclonal antibody. The rest of them show different degrees of response,~     although the rate of asthmatics who achieve control of the disease is unknown because~     clinical trials of omalizumab have been carried out to assess the impact of the drug on~     exacerbations, symptoms or even pulmonary function, but its effect on control was not~     evaluated. Therefore, there is a need to find new therapeutic options for those severe~     asthmatics who remain uncontrolled despite having received all the recommended therapies~     (including omalizumab). Reslizumab is a humanized anti-interleukin-5 (IL-5) monoclonal~     antibody (mAb) that has been recently found to reduce exacerbations and to improve pulmonary~     function and symptoms in patients with severe asthma and high peripheral eosinophil counts.~     It would be important to demonstrate that Reslizumab is able to improve the clinical~     condition of severe asthma patients with no therapeutic options.~   "
37565|NCT03074929|"~     One-third of American children are overweight or obese, leading to an increased risk for~     cardiovascular disease (CVD), early mortality, and other risks throughout their lifespan~     relative to normal weight children. In our pilot work, we found that 67-83% of parents~     underestimate a child's long-term risk of developing cardiovascular disease in adulthood and~     that parents thought their own child's risks were 13-15% lower than those of a typical child~     in their community, even controlling for family health and demographic characteristics.~     Parents were 40 times less likely to predict that their child, rather than a typical child in~     their community, would be overweight or obese in adulthood. These findings suggest that~     parents suffer from optimism bias, the tendency to overestimate one's chances of experiencing~     unlikely positive events. Belief that a child is at increased risk for adverse health~     outcomes in adulthood could be an important motivator for a family to initiate behavior~     changes and vice versa.~      The overall goal of this research is to develop provider-based risk communication approaches~     to motivate parents of obese children to engage in behavior change to protect their children~     from CVD and other obesity-related co-morbidities later in life. Specifically, the~     investigators will:~        1. Develop risk communication methods that providers can use to better convey accurate~          information about a child's health behaviors, obesity status, and future health risks to~          parents.~        2. Using an online experiment, we will evaluate the impact of new risk communication~          methods on parental engagement in behavior change.~        3. Pilot test the feasibility, acceptability, and impact of new risk communication~          approaches in pediatric primary care clinics.~      This work will give pediatricians novel tools to effectively discuss the long-term~     consequences of childhood obesity with parents. The findings from this work will inform an~     interventional trial that will assess the impact of improved risk communication techniques on~     child behavior change and health outcomes.~   "
37566|NCT03074916|"~     The objective of this project is to investigate the subjective and clinical outcome in~     patients at least one year after DIP arthroplasty and compare them to matched patients with~     an arthrodesis.~      The primary endpoint is the satisfaction with the treatment result of in the~     motion-preserving DIP surgery at follow-up.~   "
37567|NCT03074903|"~     Women presenting for contraception will be offered the IUS Skyla and study participation.~     Daily bleeding will be collected for a total of 90 days and correlated with insertion timing~     and baseline endometrial thickness.~   "
37568|NCT03074890|"~     Massive haemorrhage is defined as the necessity of 3 or more packed red blood cells in one~     hour, the transfusion of 10 packed blood cells, the loss of the half of the blood volume, the~     loss of 4-5 cc/kg/h or more, and haemorrhage shock.~      Haemorrhage shock provokes changes in the bloodstream with celular and organic disfunction.~     In many cases massive transfusion is needed to stabilize the vital function. This massive~     transfusion can have serious side effects (infectious and immunologic and no immunologic~     reactions) and increase the morbidity and mortality.~      Massive transfusion protocols improve the survival in severe trauma injury patients. The~     transfusion of fixed rate of packed red blood cells, fresh frozen plasma and platelet~     concentrates have decreased the severity of trauma induced coagulopathy.~      Recently several studies have shown the benefit of massive transfusion protocols with high~     transfusion ratios (1:1:1 RBC:FFP:PLT) in mortality after severe trauma. So early and~     aggressive transfusion improve the outcomes and the resources.~      Massive Transfusion Protocol have been elaborated in the Hospital Universitario de Canarias~     with high transfusion ratios (1:1:1 RBC:FFP:PLT) . The goals of this protocol is to reduce~     the variability in the clinic experience, to reduce the transfusion necessities and to assure~     an safe treatment with blood products.~      So with this study the investigators will evaluate if the goals of this Protocol are followed~     and if the use of this Protocol is really safe and efficient.~   "
37569|NCT03074877|"~     This study is to test the effectiveness of integrating and adapting two National Institute on~     Drug Abuse (NIDA)-funded procedures for use in primary care pediatric clinics serving~     low-income youth: 1)the Youth Risk Index (YRI) and Transmissible Liability Index-Parent~     (TLI-P) nurse and/or research assistant-administered screening tools for high risk of~     substance use (SU) prior to high school and thus also for SUD and 2) the Family Check-Up~     (FCU) - a brief, family-based program to prevent SU/SUD with replicated efficacy.~   "
37570|NCT03074864|"~     The aim of this study is to investigate the efficacy and safety of intercalated combination~     of erlotinib and radiotherapy for patients with EGFR-mutant, unresectable, locally advanced~     NSCLC, and to explore a new treatment strategy for this subset. After Induction by erlotinib,~     local radiotherapy is intercalated, and followed by 24-week erlotinib maintenance.~   "
37573|NCT03074825|"~     Chiauranib may stop the growth of tumor cells by blocking Aurora kinase B（Aurora~     B）、VEGFR/PDGFR/c-Kit、CSF-1R targets.~      This clinical trial is studying the efficacy and safety of chiauranib works in treating~     patients with relapsed or refractory non-Hodgkin's lymphoma, in the meantime, exploring the~     latent biomarkers accompany with chiauranib, as well as the relevancy of which and clinical~     benefit.~   "
37576|NCT03074786|"~     Participants will be randomized (1:1) to one of two sequences of a vaginal ring (VR)~     containing 25mg of dapivirine to be inserted monthly for 24 weeks and 200 mg FTC/300 mg TDF~     oral tablets taken daily for 24 weeks. After completing the randomized sequence of two study~     product use periods, participants will then select between the two study products to use in~     the final 24 weeks of the trial. Participants will be able to choose either or neither study~     product every 4 weeks during the third product use period.~   "
37577|NCT03074773|"~     Anesthetic management for surgery of aortic coarctation needs special care due to severe pain~     during lateral thoracotomy incision, the intraoperative hemodynamic instability related to~     skin incision at lateral thoracotomy, clamping and declamping of the aorta, needs of large~     doses of analgesia perioperative, needs of vasodilators. Also, postoperative care of the~     patients after repair is very important issue. The investigators will compare the effect of~     para-vertebral block with bupivacaine alone or with dexamethasone on Intra and postoperative~     analgesia.~   "
37578|NCT03074760|"~     A major water supply utilized in the Lambayeque region are acequias. Acequias are irrigation~     canals that are utilized by the agriculture industry for the cultivation of consumables.~     Utilization of contaminated water to irrigate consumables can lead to foodborne illnesses.~     Contamination studies on the acequias in the Lambayeque region have not been performed to~     date. The purpose of this study is to test contamination of acequias in 9 districts in~     Lambayeque and determine if a difference in infection rates exists in districts with~     contaminated acequias vs. districts without contaminated acequias for the following diseases:~     H. pylori, Adenovirus, Rotavirus.~   "
37579|NCT03074747|"~     Background: Obstructive sleep apnea (OSA) refers to the apnea and hypopnea caused by upper~     airway obstruction during sleep. Patients are associated with sleep disorders, frequent~     desaturation, hypertension, coronary heart disease, cerebrovascular disease and diabetes. OSA~     prevalence increased in China in recent years. It is estimated that nearly 80% of men and 93%~     of women are not diagnosed for moderate and severe OSA. Anesthesiologists and surgeons paid~     more attention on those high risk patients. The gold standard for OSA diagnosis is apnea and~     hypopnea index (AHI) obtained from polysomnography (PSG). But it is difficult to carry out~     PSG regularly in primary health care institutions in China for its high cost and long waiting~     list. So many OSA questionnaires are developed in Europe and North America, obesity is an~     important risk factor for OSA for them. But in China people have different anatomical~     characteristics, the diagnosis sensitivity and specificity of those methods has not been~     reported in China.~      Methods and Design: Participants for this study will be recruited in Beijing Tongren Hospital~     scheduled for elective surgery under general anesthesia. A total of 1200 adult male patients~     will be enrolled. It is including 3 kinds of persons. 1. To accept PSG monitor in sleep~     center. 2. To receive OSA correction surgery (UPPP). 3. To receive ophthalmological surgery~     under general anesthesia.~      Detailed inquiry and record all medical history. Upper airway assessment will be recorded.~     Preoperative snoring questionnaires will be integrated according to the four questionnaires.~     All patients complete PSG monitor. For patients undergoing surgical treatment, postoperative~     continuous pulse oximetry will be recorded for 24 hours. All postoperative adverse events~     will be recorded.~      The primary endpoint:~      All the patients complete the four snoring questionnaires (ASA, Berlin, STOP and STOP-BANG)~     before PSG test.~      The secondary endpoints:~      PSG monitor will be completed before operation. Medical history, upper airway assessment,~     postoperative 24 hours continuous pulse oximetry monitor and all perioperative adverse events~     will be recorded.~      The purpose is to compare the specificity and sensitivity of four questionnaires to figure~     out OSA. To find suspected OSA patients before operation with one easy-to-use assessment~     questionnaire and direct OSA clinical practice.~   "
37580|NCT03074734|"~     Within the TackSHS project (H2020 project grant agreement No 681040), we will conduct a~     clinical research study, aiming at: i) to measure respiratory health effects when exposed to~     secondhand smoke (SHS) in patients with asthma and Chronic Obstructive Pulmonary Disease~     (COPD); ii) to investigate exposure levels to SHS in smoking areas provided by bars, casinos,~     bingo halls, etc. The study will involve 60 patients (volunteers) in three European~     countries: Hungary, Ireland, and Spain, recruiting 20 patients in each participating country~     (10 COPD and 10 asthma patients).~   "
37581|NCT03074721|"~     The PCI Suite is developed by Philips Medical Systems, a Philips Healthcare company. The~     proposed PCI Suite is a new software package which can be used during coronary interventions.~     The software package includes two sub-packages, known as StentBoost and Cardiac Roadmapping.~      The patient will undergo standard of care medical treatment for his or her cardiac condition.~     During the procedure, the physician may make angiograms for diagnosis and as reference for~     device navigation as part of the standard care. These angiograms will be automatically~     processed in PCI Suite and displayed on fluoroscopy for navigation support. In case a balloon~     catheter is inserted into the coronary arteries, the physician may take cine images as part~     of the standard care. These images can be automatically enhanced in PCI Suite. The primary~     objective of this prospective, mono-center, randomized clinical trial is to evaluate the~     amount of contrast medium used during percutaneous coronary intervention.~   "
37582|NCT03074708|"~     Background:The aim of the study is to value the application of three-dimensional~     visualization and three-dimensional printing in the hepatobiliary and pancreatic~     surgery.Method：From January 2016 to December 2018,the clinical data of 200 patients with the~     hepatobiliary and pancreatic diseases will be collected.All the patients received abdominal~     CT scanning and 3D reconstruction. Then we used the 3D reconstruction model and the 3D~     printed model based on the 3D reconstruction model in the operation planning and the~     operation.The clinical data include operative time, intraoperative blood loss,and~     postoperative complications after surgery.~   "
37583|NCT03074695|"~     The primary purpose of this study is to determine differences in block quality between the~     dural-puncture epidural (DPE) and standard epidural (EPL) techniques for labor analgesia in~     the morbidly obese patient. The investigators hypothesize that when compared to the standard~     EPL, the DPE technique will improve block quality .~      Study participants will be randomized by computer-generated sequence to EPL or DPE arms,~     stratified by class of obesity (BMI < 50 kg/m2 and ≥ 50 kg/m2) and by parity (nulliparous~     versus multiparous). All patients will receive a neuraxial technique in the sitting position~     at L3/4 or L4/5 using loss of resistance to saline. In the DPE group, a 25-g Whitacre needle~     will be used to puncture the dura. In both groups, the epidural catheter will be threaded 5~     cm in the epidural space with an initiation dose of 15 ml of ropivacaine 0.1% with fentanyl~     (2 mcg/ml) over 6 minutes as per standard practice. After the initial loading dose and~     epidural pump is started, the blinded investigator will enter the patient's room to start~     data collection (time 0). Data will be collected for the first 30 minutes of epidural~     placement at 3,6,9,12,15,18 21, and 30 minutes to detect the time to achieve target pain ≤~     1/10, then assessed at standardized times (ever 2 hour) until delivery. Breakthrough pain~     will be managed by a standardized protocol. Other data to be collected will include: catheter~     adjustments and replacements, physician top-ups, asymmetrical block, pain score, motor block,~     sensory level to ice, hypotension, total anesthetic dose required, and PCEA use.~      The primary outcome of this study is block quality defined by a composite of five components:~     (1) asymmetric block after 30 minutes of initiation, (2) top-up interventions, (3) catheter~     adjustments (4) failed catheter requiring replacement, and (5) failed epidural requiring~     general anesthesia or replacement neuraxial anesthesia for emergency cesarean section.~     Secondary outcomes include time to numeric pain rating scale ≤1, maternal adverse events~     (hypotension, fetal bradycardia, PDPH), motor block, duration of second stage of labor, total~     labor epidural time, total anesthetic dose required, PCEA use, and mode of delivery.~      There is no increased risk/safety issue with placing a dural puncture technique than with~     epidural for labor analgesia.~   "
39232|NCT03053154|"~     The purpose of this study is to assess and determine the influence of pelvic inclination on~     sit to stand task in stroke patients.~   "
37586|NCT03074656|"~     Infliximab and other TNF-inhibitors have revolutionised the treatment of several~     immunological inflammatory diseases. Still, more than half of the patients either do not~     respond sufficiently to infliximab therapy or loose efficacy over time. The large individual~     variation in the serum drug concentrations on standard doses and the development of anti-drug~     antibodies are thought to be main reasons for these treatment failures. An individualised~     treatment strategy based on systematic assessments of serum drug concentrations, therapeutic~     drug monitoring, has been proposed as a clinical tool to optimise efficacy of infliximab~     treatment. Therapeutic drug monitoring seems reasonable both from a clinical and an~     economical point of view, but the effectiveness of this treatment strategy still remain to be~     shown. The NOR-DRUM study is planned as a national, randomised controlled multicentre trial~     in two parts aiming to assess the effectiveness of therapeutic drug monitoring in order to~     achieve remission in patients with immunological inflammatory diseases starting infliximab~     treatment (part A) and in order to maintain disease control in patients on maintenance~     infliximab treatment (part B). The results of the NOR-DRUM study will hopefully contribute to~     an implementation of a personalised medicine approach to treatment with infliximab and other~     biological drugs.~   "
37587|NCT03074643|"~     This study will evaluate the effects of diet composition (i.e., amount of protein and~     carbohydrate) during a 6-month weight loss intervention and 12-months of follow-up on~     physical function, muscle mass, and weight loss maintenance in obese older adults.~     Participants will receive either a protein or carbohydrate supplement along with a behavioral~     weight loss intervention.~   "
37588|NCT03074630|"~     Objective: To investigate the effect of 5 weeks dapagliflozin 10 mg once daily treatment on~     glucose and lipid fluxes in patients with type 2 diabetes.~      Study design: Single center single arm (mechanistic) intervention trial.~      Study Population: Male or postmenopausal female patients with type 2 diabetes BMI > 25~     kg/m2and more than 12 weeks a stable dose of metformin treatment > 1500mg, HbA1C ≥6.5% -~     <8.5%, Fasting Plasma Glucose (FPG) <13.2 mmol/l, LDL cholesterol >2.5 mmol/l, willing to~     switch to rosuvastatin 10mg once daily for 4 weeks, and then receive 10 mg dapagliflozin once~     daily orally, for 5 weeks.~      Treatment: After a statin washout fase of 4 weeks, baseline cholesterol synthesis will be~     measured (2H3 Leucine, 2H2O deuterated water). Then, treatment with rosuvastatin 10mg for 4~     weeks will be initiated after which, patients will undergo glucose (2H2enriched glucose) and~     lipid flux (2H3 Leucine, 2H2O deuterated water and oral 1,2,3,4-13C16 - palmitate enrichment~     measurements) followed by 5 weeks treatment with dapagliflozin 10mg once daily. In the final~     week glucose/lipid flux measurements will be repeated.~      Sample Size: 12 DM2 subjects.~      Outcome measures: The primary endpoint is effect of 5 weeks Sodium-Glucose Linked~     co-transporter (SGLT) 2 inhibition on LDL cholesterol synthesis in patients with DM2.~     Secondary endpoints are effect of SGLT2 inhibition on triglyceride and cholesterol fluxes as~     well as (hepatic and peripheral) insulin sensitivity and energy expenditure. Finally, effect~     of SGLT2 inhibition on dietary intake, liver fat content (MRI liver) and fecal microbiome~     will be studied at these timepoints.~   "
37589|NCT03074617|"~     The effect of electromagnetic fields of the latest standard in mobile communication (long~     term evolution, LTE) on sleep is studied in healthy, young individuals.~   "
37590|NCT03074604|"~     The objective of this study is to investigate the value of employing the aortic no-touch~     off-pump coronary artery bypass technique and the practice of carbon dioxide surgical field~     flooding for the prevention of type 1 and 2 neurological injuries following surgical coronary~     revascularization.~   "
37591|NCT03074591|"~     This study addresses, whether treatment with IV iron for patients with heart failure with~     preserved ejection fraction (HFpEF) and iron deficiency (ID), both with or without anaemia,~     can improve exercise capacity as measured by 6-minute walking test (6-MWT) and symptoms while~     being safe~   "
37592|NCT03074578|"~     There is a need for quantify the emotional and neurophysiological perception of verbal~     violence, in order to understand the impact it might have on a subject. This project aims at~     assessing the influence of time, sleep, and people interaction on the perception of verbal~     violence.~   "
37593|NCT03074565|"~     Periodontitis is a chronic oral infection that results in the breakdown of connective tissue~     and alveolar bone that support the teeth. Non-surgical sanative therapy using a combination~     treatment of hand and ultrasonic instrumentation is the primary treatment option for patients~     with periodontitis. However, the hand-held instrumentation requires continuous sharpening for~     optimal outcomes, which introduces tremendous variability as well as a large increase in time~     spent by the treating dental hygienists. Therefore, this study aimed to determine if~     ultrasonic instrumentation alone can provide similar improvements to periodontal outcomes~     compared to ultrasonic plus hand instrumentation.~   "
37594|NCT03074552|"~     Ventilator-associated pneumonia (VAP), is a type of pneumonia that develops more than 48~     hours after endotracheal intubation, is common in intensive care units (ICUs). It is~     estimated to be responsible for 27% to 47% of ICU-acquired infections.~      The pathogenesis of VAP is complex but typically involves colonization of the aerodigestive~     tract with pathogenic bacteria, the formation of biofilms, and microaspiration of~     contaminated secretions. Preventing carriage of potentially pathogenic micro-organisms from~     the aerodigestive tract is an infection control strategy used to reduce the occurrence of~     VAP. One novel intervention is the administration of prophylactic probiotics which restore~     non-pathogenic flora that compete with pathogens, modulate local and systemic immunity, and~     decrease intestinal permeability and thus can be beneficial in preventing nosocomial~     infections in critically ill patients. The role of the probiotics in preventing VAP in~     mechanically ventilated patients is inconclusive. Some evidence indicates that probiotics may~     reduce the incidence of VAP by inhibiting pathogen adhesion, improving gut mucosal barrier~     function, reducing bacterial translocation and up-regulating the immune system. Furthermore,~     guidelines remain inconclusive regarding the role of commensal oropharyngeal flora (COF) as a~     causative agent in VAP, mainly due to a scarcity of studies in this research field. However,~     there is evidence that COF may cause pulmonary infection, mostly in immunocompromised~     patients.~   "
37606|NCT03074396|"~     The investigators developed and used the DialysisNet mobile application for physicians and~     Avatar Beans mobile application for haemodialysis patients. Patient-centred data integration~     and exchange were based on the American Society for Testing and Materials Continuity of Care~     Record standard. The investigators enrolled 10 patients and 4 physicians. Questionnaires to~     evaluate user experience and usefulness were administered before and after use.~   "
37595|NCT03074539|"~     There is evidence for a high prevalence of Sleep Disorder Breathing (SDB) in patients with~     Chronic Thromboembolic Pulmonary Hypertension (CTEPH). Central Sleep Apnea, Cheyne-Stokes~     Breathing and Obstructive Sleep Apnea appear to occur in CTEPH. However, there is no~     information on the impact of CTEPH treatment modalities on concomitant SDB. Furthermore, the~     use of PAP therapy in CTEPH has not yet been investigated. CTEPH is a rare and serious~     disease and there may be a bidirectional association of SDB and CTEPH.~      This study plans to investigate the prevalence of SDB in CTEPH and compare it to datasets of~     large epidemiological studies on SDB. Furthermore, the impact of CTEPH treatment on SDB will~     be analyzed and CTEPH patients for possible PAP treatment will be defined.~   "
37596|NCT03074526|"~     To evaluate the efficacy of Lyophilized amniotic fluid as compared to the Saline Injection,~     placebo control in the treatment of moderate osteoarthritis of the knee.~   "
37597|NCT03074513|"~     The goal of this clinical research study is to learn if atezolizumab and bevacizumab can help~     to control rare solid tumors.~      This is an investigational study. Atezolizumab is FDA approved and commercially available for~     the treatment of metastatic (has spread) non-small cell lung cancer (NSCLC).~      Bevacizumab is FDA approved and commercially available for the treatment of metastatic~     colorectal cancer, metastatic non-squamous NSCLC, metastatic renal cell carcinoma, recurrent~     (has come back after treatment) glioblastoma, cervical cancer, and platinum-resistant (a type~     of chemotherapy) recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer.~      The combination of these drugs to treat the type of cancer you have is considered~     investigational. The study doctor can explain how the study drugs are designed to work.~      Up to 160 participants will be enrolled in this study. All will take part at MD Anderson.~   "
37598|NCT03074500|"~     The aim of this study is to compare the effects of kinesiology taping with exercise, sham~     taping with exercise and exercise alone for lateral epicondylitis.~   "
37599|NCT03074487|"~     During open surgery of a thoraco-abdominal aortic aneurysma (TAAA), diminished blood flow to~     the myelum can result in hypoxia, compromising proper function of the spinal cord.~      Intraoperatively, motor evoked potentials (MEP) are elicited to measure the functional~     integrity of the spinal cord. MEPs have proven to be a reliable marker of spinal cord~     ischemia. Moreover, these potentials react within minutes, which facilitates interventions to~     restore the blood flow. Monitoring intraoperatively with this ancillary test has reduced the~     rate of paraparesis to < 5%. Unfortunately, in the early postoperative period, spinal cord~     vulnerability is high. Therefore, some patients develop paraparesis, not during the surgical~     procedure, but after the surgical procedure. Postoperatively, suboptimal blood flow may lead~     to critical loss of function. This inadequate perfusion results in delayed paraparesis. In~     the postoperative patient, it is not possible to measure MEPs when sedation is decreased, due~     to the high intensity of the electrical stimulus, which is unacceptably painful in the~     unanesthetized or partially anesthetized patient. Therefore ancillary tests are needed which~     can detect spinal cord ischemia postoperatively early, thus preceding the phase with~     clinically overt paraparesis. The test should be reliable and easy to perform for an extended~     period of time (up to several days).~      The purpose of this study is to explore the usefulness of various neurophysiological tests~     regarding accuracy and feasibility for the detection of spinal cord ischemia. In particular,~     to find a diagnostic test which is acceptable for the unanesthetized or partially~     anesthetized patient and therefore can also be performed postoperatively. These tests will be~     examined in fully sedated as well as partially sedated patients.~      The following candidate tests will be examined:~        1. Long loop reflexes (LLR) consisting of F-waves.~        2. Oxygenation measurements of the paraspinal muscles using Near-infrared spectroscopy~          (NIRS).~   "
37600|NCT03074474|"~     The study is designed to demonstrate that the use of OviTex® 1S material for a ventral hernia~     repair leads to the same or a lower percentage of early post-operative complications and true~     hernia recurrences when compared to other types of available meshes. 100 subjects will be~     included from 5-7 participating investigator sites. Within 30 days prior to the hernia repair~     surgery, a baseline visit will be performed during which the patient's eligibility for the~     study will be evaluated. The surgical technique used for the repair will be determined by the~     investigator/surgeon. Additional study data will be collected during the hospital stay, 30~     and 90 days post-operatively and 12 and 24 months post-operatively. At the follow up visits,~     the surgical site will be evaluated by the surgeon, both the surgeon and patient will be~     asked to rate their satisfaction with the repair and the subject will be asked to complete~     two Quality of Life questionnaires.~   "
37601|NCT03074461|"~     CSAR Trial's aim is to determine whether the transverse coloplasty pouch or the side-to-end~     anastomosis as rectal reservoir reconstruction offers the best functional results.~   "
37602|NCT03074448|"~     Poor or inadequate bowel preparation is one of the most common reasons for a repeated or~     failed colonoscopy. Preparation methods shown to be effective include the use of either~     bowel-cleansing devices or oral laxatives. Despite the acceptable effectiveness and safety of~     both bowel-cleansing methods, very few studies have been performed to evaluate which method~     is more effective. The main aim is to perform an observational study followed by propensity~     score modeling to evaluate and compare the quality of bowel preparation with the use of~     Aquanet bowel-cleansing devices versus the use of oral Sodium picosulfate solution. The study~     will involve 314 patients requiring a colonoscopy, between 14 and 90 years of age and with~     more than three bowel movements per week for the past one month. Outcomes of interest being~     the quality of bowel preparation evaluated through the Boston Bowel Preparation (BBP) scale.~     The investigator hypothesized that the bowel preparation with Aquanet bowel-cleansing device~     for colonoscopy will provide a better outcome for the patient than with conventional methods.~   "
37603|NCT03074435|"~     This study evaluates the benefit to use 1) insecticidal paints, 2) larvicides, 3) Ivermectin~     for both human and domestic animals and 4) strengthened Information, Education and~     Communication (IEC) strategy to complement the universal coverage with LLINs through a~     cluster randomized trial.~   "
37604|NCT03074422|"~     In certain neurosurgical procedures, the use of a stereotaxic frame is required. It is then~     possible to set a precise target (depending of the type of the surgery) to be reached by the~     surgeon. The fixation of the stereotactic frame on the awake patient's head is done under~     local anesthesia by screwing the frame directly into the skull. This procedure is reported as~     painful to extremely painful by patients. The objective of this study is to determine~     whether the hypnosis is effective in decreasing the pain perceived by the patient during the~     disposal of the stereotactic frame.~   "
37605|NCT03074409|"~     This study is designed to investigate oxytocin's effects on interoception and whether these~     effects vary as a function of different emotional valence.~   "
39955|NCT03043729|"~     Patients with locally advanced rectal or rectosigmoid cancer staged cT3 CRM-negative with MRI~     will receive 6 cycles of neoadjuvant treatment with mFOLFOX6 (Arm A) vs. mFOLFOX6 +~     aflibercept (Arm B) followed by surgery.~   "
37607|NCT03074383|"~     Ninety-six patients with diabetes will be randomly assigned to maintain standard treatment or~     participate in the Self-Care Multidisciplinary Workshop for Diabetes. The workshop consists~     of individual meetings, with a multidisciplinary team (nurse, pharmacist, nutritionist,~     physical educator and social worker) in which education and self-care topics will be~     approached aiming at the formation of knowledge and skills necessary for patient self-care.~     The workshop will be offered in 3 different modules with 2 to 4 weeks difference between~     them. The variation of glycated hemoglobin as well as aspects associated with self-care,~     adherence and treatment satisfaction will be evaluated at the study entry, 6 and 12 months~     later.~   "
37608|NCT03074370|"~     Evaluation of Smile Esthetics in Orthodontically Treated Adult Female Patients with~     Bimaxillary-dentoalveolar Protrusion.~      A Retrospective Cohort Study.~   "
37609|NCT03074357|"~     This biomarker study is a follow-up to CPLATFRM2201. The goal of CBASICHR0005 is to collect~     another urine sample, interval clinical information, and an optional DNA sample from as many~     of the original 80 patients as possible. This new information will transform the data~     obtained in PLATFRM2201 from a cross-section to a temporal profile, which will (a) further~     enable the identification of biomarkers predictive of faster progression, and (b) satisfy the~     FDA's recommendation to perform natural history studies in rare diseases.~   "
37610|NCT03074344|"~     Background: Dry eye disease (DED) is a common condition causing burden on visual function and~     reducing quality of life. Corticosteroids and/or cyclosporine eye drops are able to improve~     DED symptoms, however, side effects of immune suppression and cost lead patients often to~     suspend treatment. Consequently, is important to identify therapies alleviating DED symptoms.~     A randomized, controlled, single masked study, was performed in 40 patients affected by mild~     to moderate DED, to evaluate efficacy and safety of a collyrium based on cross-linked~     hyaluronic acid (XLHA) added with Coenzyme Q10 (CoQ10) in comparison to an eye drop~     considered a gold standard for tear substitutes, based on hyaluronic acid (HA) 0.15%.~      Methods: eye drops were administered four times a day for 90 days to enrolled subjects~     divided in two groups: group A treated with XLHA+CoQ10, group B treated with HA. Ocular~     Surface Disease Index (OSDI) questionnaire, visual acuity, intraocular pressure (IOP), fundus~     exam, tear break-up time (TBUT), corneal and conjunctival fluorescein staining, corneal~     esthesiometry, corneal confocal microscopy, were performed at different visits until the 90th~     day.~   "
37611|NCT03074331|"~     The primary objectives of this study are to evaluate the efficacy, safety, and tolerability~     of treatment with sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) fixed-dose combination (FDC) for~     12 weeks in adults with chronic hepatitis C virus (HCV) infection.~   "
37612|NCT03074318|"~     This phase I/II studies the side effects of avelumab and trabectedin and how well they work~     in treating patients with leiomyosarcoma or liposarcoma that has spread to other places in~     the body or cannot be removed by surgery. Monoclonal antibodies, such as avelumab, may block~     tumor growth in different ways by targeting certain cells. Drugs used in chemotherapy, such~     as trabectedin, work in different ways to stop the growth of tumor cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. Giving~     avelumab and trabectedin may work better in treating patients with liposarcoma or~     leiomyosarcoma.~   "
37613|NCT03074305|"~     The aim of the study is to compare angiographic outcomes following revascularization using~     drug-eluting balloon (DEB) versus 2nd generation drug-eluting stent (DES) in treatment of~     Bioresorbable Vascular Scaffold Restenosis.~   "
37614|NCT03074292|"~     The aim of the present study is to test a hypothesis assuming that phototherapy might have an~     effect on oxidant/antioxidant status in term and late-preterm neonates with unconjugated~     hyperbilirubinemia.~   "
37615|NCT03074279|"~     Numerous studies over the past decade have shown without any doubt that there is a higher~     mortality risk in patients with epilepsy than in the general population. The cause of death~     may be related to the cause of epilepsy, being directly related to a seizure (status~     epilepticus or sudden unexpected death in epilepsy; SUDEP), a consequence of seizures~     (accidents, etc), other associated pathologies (cancer, cardiovascular disease, ischemic~     heart disease, pneumonia, etc) or an associated disorder (depression or suicide). A SUDEP is~     defined as a sudden, non-traumatic, unexpected death in a patient with epilepsy, not~     necessarily in the presence of witnesses, that is not due to drowning, with or without~     evidence of a seizure, excluding documented status epilepticus and in which a post-mortem~     autopsy reveals no anatomical or toxicological cause of death. Little is known about SUDEP~     and its mechanisms and risk factors.~      This epidemiological study is based on the RSME. The Main objective of this study to identify~     risk factors of SUDEP, in particular night-time supervision and the risks associated with~     anti-epileptic drugs including compliance and drug interactions.~   "
37616|NCT03074266|"~     This study is designed to evaluate and verify the clinical accuracy of the Hemochron® MCS~     7000 Whole Blood Microcoagulation System; a point-of-care, whole blood Activated Clotting~     Time (ACT) measurement in comparison with the Hemochron Signature Elite® Whole Blood~     Microcoagulation System; a 510(k) cleared predicate device. This is a multi-center,~     prospective method comparison, with data to be analyzed separately from each site as well as~     combined for all sites.~   "
37617|NCT03074253|"~     Cardiovascular Imaging and Biomarker Analyses (CIBER) is a single-center, prospective and~     observational study evaluating the expression of novel biomarkers in patients undergoing~     cardiacvascular imaging within clinical routine care. It is aimed to evaluate associations~     with biomarker expressions with ascertained cardiac imaging parameters.~   "
37618|NCT03074240|"~     Compare the ability of the transversus abdominis plane block (TAPB) and rectus sheath block~     (RSB) to provide surgical anesthesia for obese patients undergoing umbilical hernia surgery.~   "
37619|NCT03074227|"~     A Double-blind randomised placebo-controlled pilot study as well as a reversed translational~     part To investigate whether two faecal transplantations from either allogeneic (healthy) or~     autologous (own) donor, administered through a nasoduodenal tube, has beneficial effects on~     irritable bowel syndrome (IBS) symptoms such as abdominal pain frequency and severity.~     Secondary objective is to study microbiota changes in faeces samples.~   "
39956|NCT03043716|"~     Telemonitoring for Positive Airway Pressure (PAP) therapy might help to establish and~     maintain long-term therapy adherence and thus support the beneficial effects of PAP therapy~     on long-term outcomes.~   "
37620|NCT03074214|"~     ST-elevation myocardial infarction (STEMI) has a serious health threaten to population. PCI,~     which can timely restore the blood flow to the ischemic myocardium, is a well-proved measure~     in STEMI management. However, the process of the restoration can induce injury. The~     phenomenon is defined as ischemia/reperfusion (I/R) injury. The studies indicate that I/R~     injury accounts for up to 50% of the final myocardial infarct size. However, previous~     attempts to target known mediators of myocardial I/R injury in patients have been~     disappointing, leading to calls for a reevaluation of factors affecting myocardial I/R injury~     [1]. Arginine vasopressin (AVP), that response to acute illness, is unstable and cleared~     rapidly from the circulation. However, copeptin, the C-terminal portion of provasopressin, is~     released in equimolar amounts to AVP and is easy to determine. So, copeptin can be a~     surrogate marker for AVP secretion. Recently, copeptin was found to serve as a potential~     prognostic biomarker in heart failure and acute myocardial infarction (AMI). AMI can activate~     the AVP axis, which have a causative role in the evolution of heart failure. Increasing~     copeptin was shown to correlate with myocardial remodeling, mortality and morbidity. In~     patients with STEMI, myocardial infarct size is a stronger outcome predictor than LV~     function, and is related to LV remodeling, which often indicates a significant worse~     prognosis after AMI. As the gold standard for characterisation of cardiac structure and~     function, cardiac magnetic resonance (CMR) parameters can serve as surrogate end points in~     clinical trials of STEMI. We hypothesised that plasma copeptin values, tested before and~     after PCI, are related to myocardial infarct size, myocardial function both and outcomes at~     baseline and 6 months follow-up as assessed by CMR in patients with STEMI.~   "
37621|NCT03074201|"~     Prospective Evaluation of the Ability of Spyglass Cholangioscopy to Facilitate Radiation Free~     ERCP for non-complex bile duct stone disease.~   "
37622|NCT03074188|"~     There are severe deficiency of database concerning the oral health status in both~     pre-dialysis and end stage renal disease in Egyptian population. Our aim in the present study~     is to assess the oral health of the chronic kidney disease patients to increase their~     awareness and minimize all the possible risk factors, to achieve a proper management for all~     oral problems.~   "
37623|NCT03074175|"~     Lung cancer is a malignant tumor that causes the highest morbidity and mortality, and the~     main pathological type is non-small cell lung cancer (NSCLC). Most of them present with~     advanced stage at diagnosis. Radiotherapy is an important treatment strategy for advanced~     non-small cell lung cancer. However patients have different responses to radiotherapy due to~     individual differences, thus there is still lacking of sensitive markers to predict treatment~     response at present. Using bioinformatics to process the data and small sample clinical~     trial, our previous study found 5 plasma miRNAs were related to radiosensitivity. The design~     is controlled clinical trial. According to the size of lung lesions, the investigators~     divided the patients into hyperfractionated radiotherapy group（50Gy/11F/2W) with lesion ≤5cm~     in diameter and conventional fractionated radiotherapy group（60Gy/30F/6W）with lesion >5cm in~     diameter.~   "
37624|NCT03074162|"~     The main objective of this study is to assess the relative systemic bioavailability of~     diclofenac in the presence and absence of capsaicin by comparing the systemic bioavailability~     of diclofenac from a combination product (Diclofenac 2% + Capsaicin 0.075% Topical Gel) with~     two diclofenac only products, Diclofenac Mono Gel 2% and Voltarol® 12 Hour Emulgel 2.32% Gel,~     following topical administration.~      In order to examine potential racial differences in pharmacokinetics (PK), the study~     population will be stratified 50:50, Caucasian versus Black people. With respect to the main~     objective, additionally a supportive analysis will be performed to investigate the influence~     of race on the intra-individual bioavailability ratios.~   "
37625|NCT03074149|"~     To gain further insight on the characteristics, management, disease progression and the~     outcomes of patients with IPF, as diagnosed and treated under real-world, clinical practice~     conditions in Greece. More specifically, this registry will be used to: Provide a~     comprehensive clinical picture of IPF, Track access to health care and cost of caring for IPF~     patients over time, Examine the implementation of treatment guidelines used on patients~     diagnosed with IPF, according to the existing diagnosis guidelines, Characterization of~     patients on different treatments. To provide information regarding survival and mortality~     causes, IPF exacerbations as well as IPF patient co-morbidities including myocardial~     infarction, CNS infarction, other arterial thromboembolic events, deep vein thrombosis,~     hemorrhage, gastrointestinal perforation and pulmonary hypertension. Data regarding IPF~     patient hospitalization will be collected and evaluated with regards to potential respiratory~     causes, and there will be documentation of treatment patterns and economic aspects. Patients~     will be followed up for 2 years and information regarding IPF treatment changes since the~     last visit will be collected.~   "
37626|NCT03074136|"~     The pulp necrosis of permanent immature teeth implies the interruption of the root formation~     and apical closure. Diode lasers have been used in many areas of dentistry, with tendency of~     good results in canal and dentine disinfection. The bactericidal effect of high-power lasers~     is based on dose dependent heat generation. Its antimicrobial effectiveness against diverse~     microorganisms has already been demonstrated. Photodynamic therapy (PDT) is a two-step~     therapeutic approach starting with the application of a photosensitizing agent and followed~     by irradiation with light energy that is spectrally matched to activate the drug. The balance~     between disinfection and the creation of an intracanal microenvironment conducive for the~     proliferation of stem cells requires further investigation. Aims of study are to compare the~     time required to obtain the clinical healing and the disappearance of clinical symptoms, and~     absence of periapical radiolucency, by using PDT and diode laser, with standard disinfection~     alone; to assess specificity of microbial load in permanent immature teeth, and root canal~     disinfection ability of PDT and diode laser, in compare with standard disinfection alone.~   "
37627|NCT03074123|"~     Previous study showed that afternoon cosyntropin testing was associated with a sevenfold~     increased likelihood of failing the 1μg test. However, in that study, investigators used a~     20.3 cm plastic tube, which might have led to uncompleted cosyntropin delivery. In ther~     current study investigators will study afternoon 1μg cosyntropin cortisol stimulation using a~     short 2.5 cm tube.~   "
39990|NCT03043274|"~     This study evaluates differences in the extent of myocardial necrosis noted by cardiac MRI in~     patients with ST-elevation myocardial infarction randomized to receive cangrelor during their~     percutaneous coronary intervention and compares them to patients randomized to not receive~     cangrelor.~   "
37628|NCT03074110|"~     Isocapnic hyperventilation (IHV) is a method that shortens time to extubation after~     inhalation anaesthesia by increasing airway carbon dioxide (CO2) during hyperventilation~     (HV). In two experimental studies (mechanical lung model and porcine model) and in a pilot~     study on patients undergoing sevoflurane anaesthesia for major ear-nose-throat (ENT) surgery,~     the investigators evaluated the feasibility of an alternative technique of IHV. By performing~     a prospective, randomised controlled study, the investigators want to further test this~     alternative method for IHV.~   "
37629|NCT03074097|"~     Good quality of postoperative analgesia would lead to attenuate or prevent the adverse~     effects on the common functions of the immune system. We compared the effect of epidural~     analgesia versus rectus sheath block on postoperative pain and proinflammatory cytokines~     following malignant urological surgery.~   "
37630|NCT03074084|"~     This is a non-randomized, prospective, population-based, single-center study designed to~     evaluate conditions resulting emergency admission in patients with abdominal pain.~     Furthermore, we are interested in how many patients are discharged with non-specific~     abdominal pain but later readmitted and diagnosed with a specific diagnosis.~   "
37631|NCT03074071|"~     The study will access whether breast cancer patients and oncologists can become more hopeful~     after participating in a hope enhancement workshop. Several validated tools, Adult Hope~     Scale (AHS), Herth Hope Index (HHI), Maslach Burnout Inventory (MBI) and other quality of~     life parameter surveys, will be administered at specified intervals.~   "
37632|NCT03074058|"~     The primary objective of this study was to establish the bioequivalence of two different~     tablet formulations containing BAY77-1931. The secondary objectives of this study were to~     assess the safety and tolerability, as well as to Investigate the plasma lanthanum~     concentration after BAY 77-1931 ODT 500 mg administration.~   "
37633|NCT03074045|"~     To evaluate user satisfaction in young nulliparous and parous women (18-29 years of age~     [inclusive]), using LCS16 compared to a COC over a period of 12 months.~   "
37634|NCT03074032|"~     This is a PhaseI, open-label study, Dose-Escalation Study, where tolerated doses will be~     escalated to the next doses with the safety, tolerability, and PK being evaluated in~     metastatic castration-resistant prostate cancer (mCRPC) patients. Tumor assessment and PSA~     values will be evaluated during the study as an additional point.~   "
37635|NCT03074019|"~     The purpose of this clinical trial is to assess the efficacy of a novel prebiotic, XOS95, at~     two different dosages, in comparison to a placebo by assessing shifts in microbial~     populations after 8 weeks of supplementation, assessed as changes in abundance of microbial~     populations.~   "
37636|NCT03074006|"~     This is a prospective, open-label, multicenter, phase 1/2 study of TEW-7197 in patients with~     low and intermediate risk of myelodysplastic syndrome (MDS).~   "
37637|NCT03073993|"~     Enteral feeding tubes in newborns are used for feeding preterm and low birth weight babies in~     neonatal intensive care units as they often do not suck effectively owing to lack of~     coordination between sucking, swallowing and breathing due to neurological immaturity and~     delayed gastric emptying.~      The feeding tubes could be inserted by the nasogastric (NG) route or by the orogastric (OG)~     route. Both routes are used in different Neonatal Intensive Care Units (NICUs). Both methods~     are associated with different adverse events.~      Since newborn infants are obligate nose breathers, nasogastric tube (NGT) can lead to partial~     nasal obstruction which might increase airway resistance and work of breathing although they~     are easy to secure to the face than orally placed tubes. Orogastric tubes (OGT), on the other~     hand, may not lead to the potential risk of increased work of breathing associated with NGT~     but are more frequently malpositioned and can loop inside the mouth. Also there is increased~     possibility of apnea and bradycardia due to vagal stimulation.~      Despite so many years of continuing debate, the evidence of superiority of one method over~     another is not proven. Very few studies have tried to look into this matter and there are no~     consensus guidelines. This study is being conducted to compare the rate and type of adverse~     events in OG versus NG feeds in preterm neonates ≤ 32 weeks and postmenstrual age (PMA) ≤ 36~     weeks.~      Preterm neonates born at ≤ 32 weeks with PMA≤ 36 weeks who require feeding tube as a route~     for enteral feeding once they are out of respiratory support ( i.e ventilation or CPAP) are~     eligible candidates. Feeding tube insertion episode (FTIE) is defined as episode of insertion~     of OG or NG tube. FTIE will be randomized into NG or OG routes. Primary outcome is frequency~     of desaturation and bradycardia in each group.~   "
37638|NCT03073980|"~     This research study is being done to compare how effective certain medications are at~     reducing pain after oocyte (egg) retrieval surgery and how effective they are at reducing the~     time between the retrieval and discharge from the hospital. The investigators will compare~     intravenous (IV) acetaminophen (Tylenol) to oral (PO) acetaminophen with IV fentanyl and to~     IV fentanyl only. The investigators also want to find out whether IV acetaminophen can reduce~     a person's need for opioid pain medications (such as morphine) to rescue breakthrough pain.~   "
37639|NCT03073967|"~     Randomized, open-label, multi-center, comparative trial to assess the efficacy and safety in~     immunocompromised subjects with acyclovir resistant mucocutaneous HSV infection, treated with~     pritelivir 100 mg qd (following a loading dose of 400 mg as first dose to rapidly reach~     steady-state plasma concentration) or foscarnet 40 mg/kg iv tid/60mg/kg iv bid.~   "
37640|NCT03073954|"~     General cognitive impairment is highly prevalent in chronic obstructive pulmonary disease~     (COPD) patients. Domain-specific cognitive impairments include deficits in domains such as~     cognitive flexibility, verbal memory, working memory, planning, and psychomotor speed; which~     in general are associated with poor health behaviours, such as infrequent exercising and poor~     diet. Additional cognitive training may reverse these effects. Recent evidence suggests that~     working memory training is linked to self-control and, indirectly, to improved lifestyle~     behaviour including increased physical activity. The investigators hypothesise that enhancing~     cognitive performance through administering specific working memory training not only~     improves cognitive function but that it facilitates better adherence to a more active~     lifestyle and a healthier diet in COPD patients.~   "
37641|NCT03073941|"~     A multicenter, prospective randomized controlled trial comparing the Persona knee system to~     the Nexgen knee system in total knee arthroplasty.~   "
37642|NCT03073928|"~     One hundred and twenty patients will be randomized to Interscalene block or Paracoracoid~     Subscapularis plane block. The study will evaluate the efficacy and duration of blocks in the~     2 groups with regards to postoperative analgesia and degree of respiratory depression.~   "
37803|NCT03071809|"~     The aim of this study is to employ genomic detection methodologies to measure the relative~     amount of tumor-derived nucleic acids in the blood of patients diagnosed with an early stage~     solid tumor who are either commencing, currently undergoing or have completed treatment. This~     approach will allow the investigators to develop a quantitative measure of therapy efficacy~     via the counting of the relative changes in tumor molecules over the course of treatment.~   "
37643|NCT03073915|"~     Patients hospitalized in internal wards are at risk for VTE. The current guidelines recommend~     the use of thromboprophylaxis for 7-10 days among patients who are at increased risk for VTE.~     Yet several retrospective studies have shown that the compliance with this guideline is low.~     Physicians are often reluctant to administer LMWH to their fragile patients mainly because~     they are not convince that the risk associated with such therapy is greater than the risk for~     VTE.~      In the current study, data concerning the use of thromboprophylaxis among patients admitted~     to the medical wards will be collected. The occurrence of bleeding or thrombotic event will~     be evaluated prospectively.~   "
37644|NCT03073902|"~     The detection of tissue PD-L1 immunohistochemistry in Non-small cell lung cancer (NSCLC) has~     an important role in guiding for the treatment of immune detection point. At the same~     time,tissue detection is time-consuming and laborious, liquid biopsy can reflect the~     information of tumor tissue,PD-L1 expression in serum and peripheral blood T cell are~     expected to be simple, rapid, non-invasive means of detection. The project is planned to~     explore the correlation of PD-L1 expression in non-small lung cancer tissue and peripheral~     blood T cell and serum..The investigators have designed to detected the expression levels of~     PD-L1 protein in cancer tissue and detected the expression levels of PD-L1 in peripheral~     blood T cell and serum.By using variance analysis of repeated measures design information.~     Thus exploring the correlation of PD-L1 expression in non-small lung cancer tissue and~     peripheral blood T cell and serum,guiding clinical practice of immunotherapy.~   "
37645|NCT03073889|"~     Forty ASA I or II patients, scheduled for aneurysm clipping were enrolled in this~     prospective, randomized, controlled study. Those patients were randomly divided into 3~     groups: Group B (Scalp nerve block before skin incision n=15), Group I (Scalp infiltration~     before incision n=15), respectively with 0.75% of ropivacaine, and Group C (the control~     group, n=15). Opioids were used to control haemodynamic responses.All patients received the~     same general anesthesia.~      After intubation, in group B, scalp block was performed by blocking the nerves that innervate~     the scalp, including the supraorbital, supratrochlear, zygomaticotemporal, auriculotemporal,~     greater occipital and lesser occipital nerves, and skin along the incision was infiltrated~     with 0.75% ropivacaine (group I, n = 15), respectively. For group C, there is no treatment.~     All patients received the same general anesthesia. The depth of anaesthesia was adjusted to~     maintain a BIS of 40-60. Characteristics of patients were recorded. Heart rate (HR) and mean~     arterial pressure (MAP) were recorded preoperatively, after induction, before skin incision,~     the moment of incision, after skin incision. Plasma levels of IL-6, IL-10, CRP were measured~     before surgery, skin incision,after the surgery. Postoperative pain scores (VAS) for 2, 4, 8,~     12, 24, 48 hours after recovery of consciousness were also recorded. Postoperative~     complications ( nausea, vomiting, infection, and other adverse events) were monitored after~     surgery.~   "
37646|NCT03073876|"~     Acetylcholinesterase inhibitors (AChE-I) comprise a class of drugs used to treat Alzheimer's~     disease (AD), but controversy about their usefulness remains. Modest response rates of~     treated versus placebo groups, small effect sizes with respect to efficacy, drug costs, and~     clinical relevance of the effects are problematic. Standard efficacy measures of efficacy are~     not sufficiently sensitive, and trying to assess cognitive change after 4-6 months of therapy~     confounds the drug effect and the natural progression of the disease.~      Surprisingly, attention has never been included in the assessment of AChE-I drugs. The~     rationale for using attentional measures are that (1) Attentional deficits are recognized as~     a critical cognitive change in the earliest phases of AD; (2) Attentional function is~     directly mediated by the cholinergic system, and responds rapidly to cholinergic~     augmentation, particularly on tasks that tax available attentional capacity are dose~     dependent; and (3) Acetylcholine is depleted in AD. However, the link between attention and~     cholinergic depletion in AD has not been fully explored, especially with regard to response~     to cholinergic treatment.~      The study tests if attentional performance can be a more sensitive marker of response. In a~     longitudinal study we measure attentional, as well as cognitive and behavioral performance in~     de novo AD patients undergoing donepezil treatment. The investigators develop visual~     attentional measures and contrast them to global and domain-specific cognitive scores on~     three occasions (T1) baseline pre-treatment, (T2) after approximately 6 weeks, and (T3) after~     6 months treatment. The T1-to-T2 arm is a double-blind placebo control period, after which~     members of the placebo group start open-label treatment. The assessment at 6 months allows us~     to determine whether the changes seen earlier at T2 can predict patients who respond, or~     determine which measures best predict response.~      We hypothesize that attention measures are more sensitive than standard global measures or~     other cognitive domains and that the change of attentional function can be detected after~     only after approximately 6 weeks treatment.~      Knowledge from this project will facilitate and inform our decisions about individual~     patients undergoing pharmacological treatment.~   "
37647|NCT03073863|"~     Epidemiological studies have shown that serum cholesterol level is correlated with~     Cardiovascular Disease (CVD) risk, and that Cardiovascular Disease (CVD) risk increases with~     increasing LDL cholesterol levels. Fortunately, it has been confirmed that~     cholesterol-lowering therapy is effective in preventing Cardiovascular Disease (CVD), and~     cholesterol lowering with statin therapy is a primary strategy in the prevention of~     Cardiovascular Disease (CVD). Despite the fact that statins reduce both LDL cholesterol and~     future cardiovascular outcome, the association of statin intensity and the achieved level of~     LDL cholesterol with cardiovascular outcome has not been fully elucidated, because statins~     have pleiotropic effect as well as LDL lowering effect.~      The effect of statin on future Cardiovascular (CV) outcome seems to be more associated with~     statin intensity relating pleiotropic effects rather than with achieved LDL cholesterol~     level, because LDL-lowering by inhibition of hepatic cholesterol synthesis is linked to~     reciprocal increment of cholesterol absorption from the intestine.~   "
37648|NCT03073850|"~     The purpose of the study is to investigate the best strategy for long-term stroke prevention~     in patients who have sinus rhythm after a successful catheter ablation for atrial~     fibrillation (AF) and who are at risk of thromboembolic events (CHA2DS2-VASc score ≥2). The~     investigators are going to compare antiplatelet therapy to oral anticoagulation (OAC) with~     different doses of edoxaban (30mg and 60mg).~   "
37649|NCT03073837|"~     This pilot study will utilize the experimental rhinovirus infection model to study changes in~     skin microbiota in relation to skin erythema and soreness.~   "
37650|NCT03073824|"~     An open-label long-term evaluation of a novel intravaginal device in female patients~     experiencing sexual and bladder function issues.~   "
37651|NCT03073811|"~     This research study will be conducted in two parts. The first part will consist of selecting~     appropriate screening and assessment tools for Veterans undergoing elective surgery and~     identifying the number of Veterans who are malnourished and at risk of malnutrition. The~     second portion of the study will be to determine if a protein-enhanced diet before and after~     surgery will improve function and postoperative outcomes and compare the results to an~     education control group.~   "
37652|NCT03073798|"~     Specific Aim: To determine the effectiveness of Roflumilast in improving i) whole right lung~     and ii) peripheral right lung mucociliary clearance (MCC) in patients with COPD and chronic~     bronchitis.~      Hypothesis: Roflumilast increases mucociliary clearance in patients with chronic bronchitis.~      Study Design: This will be a double-blinded, cross-over randomized controlled trial with 1:1~     randomization of 20 individuals with chronic bronchitis. Subjects will undergo baseline MCC~     then will be randomized to either roflumilast or placebo x 4 weeks, then there will be a 4~     week wash-out phase and a second 4 week period of roflumilast/placebo depending on initial~     randomization. MCC will be conducted at baseline and at the end of each 4 week medication~     phase.~   "
37653|NCT03073785|"~     This randomized phase II trial studies how well hypofractionated stereotactic body radiation~     therapy and fluorouracil or capecitabine with or without zoledronic acid work in treating~     patients with pancreatic cancer that has spread from where it started to nearby tissue or~     lymph nodes. Hypofractionated stereotactic body radiation therapy is a specialized radiation~     therapy that sends higher doses of x-rays over a shorter period of time directly to the tumor~     using smaller doses over several days and may cause less damage to normal tissue. Drugs used~     in chemotherapy, such as fluorouracil and capecitabine, work in different ways to stop the~     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Zoledronic acid is used in cancer patients to reduce cancer~     symptoms and may make tumor cells more sensitive to radiation. Giving hypofractionated~     stereotactic body radiation therapy and fluorouracil or capecitabine with or without~     zoledronic acid may work better in treating patients with pancreatic cancer.~   "
37654|NCT03073772|"~     Many patients with exhaustion disorders continue to have significant difficulties with~     attention and memory function which reduce their work ability. This randomized study~     investigates whether the addition of a 12-week period of specific cognitive training or~     physical fitness training could further enhance cognitive function in patients with~     exhaustion disorder participating in a multimodal rehabilitation program.~   "
37655|NCT03073759|"~     This study will be performed in patients with peripheral neuropathy who are walking~     independently, but have complains of balance problems such as recent falls or difficulty~     walking and show reduced vibratory and proprioceptive sensation during routine neurologic~     examination. These patients will be tested for proprioceptive and vibratory threshold at the~     toes and ankles before, during and after receiving anodal direct transcranial cortical~     stimulation (dTCS) over sensory and motor cortices. Subjects will be asked to participate in~     2 sessions.~   "
37656|NCT03073746|"~     There are large differences in knowledge between patients and healthcare providers (i.e.~     physicians, physician assistants and nurse practitioners), and there is a strong interest on~     the part of both industry and academia to reduce the gap in knowledge between patients and~     healthcare providers. Currently, about 1 in 20 searches on Google are health related. Among~     internet users, 72% reported searching for health information, and among persons who use~     mobile phones, 31% of cell phone users and 52% of smartphone users have looked up health or~     medical information. Oftentimes, patients will search on Google or other search engines in~     order to find health conditions that explain their symptoms prior to visiting their~     healthcare provider. With the launch of Google's new health search tools for mobile devices~     (i.e. smartphones, tablets, etc.) it is important to understand how patients use these search~     platforms and what their effects are on clinical encounters. The main objective of this study~     is to understand the accuracy of differential diagnoses generated by Google searching; the~     investigators hypothesize that searching on Google using a tablet or mobile device will be~     more accurate than not using any search tool, and that the new health search experience will~     improve accuracy over the standard search platform.~   "
37657|NCT03073733|"~     This study evaluates the changes in visual function at 12 months following a single injection~     of human retinal progenitor cells compared to sham treated controls in a cohort of adult~     subjects with RP.~   "
37658|NCT03073720|"~     To determine the correlation between bioavailable Vitamin D values and euploid status of the~     embryos in larger size follicles from UAE women undergoing in vitro fertilization procedures.~   "
37659|NCT03073707|"~     Bloodstream infections caused by non-typhoid Salmonella (NTS) are a major killing disease in~     Sub-Saharan Africa. Despite the high case fatality rate, the main reservoir -human, zoonotic~     or environmental- for invasive NTS rests unknown.~      The main objective of this study is to assess~        1. the household environment (household member, cattle and pets, rats) for intestinal~          carriage of NTS and~        2. the household water supply for presence of NTS .~      Households of children with proven NTS invasive infection will be addressed.~   "
37660|NCT03073694|"~     The purpose of this trial is to compare the morbidity and mortality of CRS-HIPEC using~     mitomycin-C versus melphalan for colorectal peritoneal carcinomatosis. Morbidity and~     mortality will measured using the Comprehensive Complication Index (CCI) score, Common~     terminology criteria for adverse events (CTCAE version 4.03), and the Clavien-Dindo~     Classification.~   "
37661|NCT03073681|"~     Patients implanted with the ReSTOR 2.5 multifocal IOL in the dominant eye and the ReSTOR 3.0~     in the non-dominant eye have overall satisfaction and spectacle independence at least~     comparable to that with bilateral implantation of the 3.0 add lens. Glare and haloes and~     other unwanted visual side effects with this mixed combination of lenses is better than with~     bilateral 3.0 lenses.~   "
37662|NCT03073668|"~     The researchers are doing this study to find out whether there will be less increase in~     cardiac filling pressure after the surgeon opens the pericardium (the membrane around the~     heart) than when the pericardium is intact. The researchers want to see whether opening the~     pericardium is an effective way to reduce the blood filling pressures in the heart.~   "
37663|NCT03073655|"~     The aim of the study to investigate the effectiveness KT application with different verbal~     inputs on pain, function and range of motion (ROM) on patient with rotator cuff tear.~   "
37799|NCT03071861|"~     This is a Phase II multicenter placebo-controlled randomized, feasibility/safety trial.~     Infants >34 week gestational age with perinatal acidemia and mild neonatal encephalopathy on~     the modified Sarnat neurologic examination at less than six hours of age. Participants will~     be randomized to receive either one dose of Darbepoetin, or placebo within 24 hours of birth.~     Neurodevelopmental testing (Bayley III and Gross Motor Function Assessment) will be performed~     at 12-18 months of age.~   "
37664|NCT03073642|"~     Fibromyalgia (FM) is a prevalent and disabling disease, that affects mostly women and its~     main characteristic is chronic pain. Several studies have shown that hydrotherapy is~     effective in the improvement of symptoms and quality of life of this population; other~     studies have shown that Pain Therapeutic Education (PTE) is also effective in this sense. PTE~     is one cheap, easy to apply intervention, with very positive results in chronic pain~     situations. However, there is a lack of studies that have shown the effects of this~     intervention on FM. Hence, this study will aim to verify the effectiveness of the~     hydrotherapy and PTE on women with FM. Sixty women will be randomly allocated in two groups:~     hydrotherapy and hydrotherapy + PTE. Before treatment start, the investigators will evaluate~     pain (visual analogue scale, presence of myofascial trigger points and pressure pain~     threshold over the scalene, upper trapezius, infraspinatus, piriformis, iliopsoas and soleus,~     bilaterally), quality of life (Fibromyalgia Impact Questionnaire and medical outcomes study~     36-item short-form health survey), depression (Beck Depression Inventory), anxiety (Beck~     Anxiety Inventory) and sleep quality (Pittsburgh Sleep Quality Index and Epworth Sleepiness~     Scale). Hydrotherapy treatment will last 12 weeks. Women will be evaluated other 3 times:~     after 6 and 12 weeks (treatment middle and end) and 12 weeks after treatment completion~     (follow-up). Women in the hydrotherapy group will receive a folder with explanations on FM.~     Women in the hydrotherapy + PTE will participate of 4 meetings over 12 treatment weeks, in~     which themes like pain physiology, pain chronification and exacerbation and pain~     self-management, as well as information on FM will be approached. Statistical analysis will~     include qualitative and quantitative variable description. Correlation among variables will~     also be analyzed. Level of significance will be set at 5%.~   "
37665|NCT03073629|"~     Millions of Americans seek emergency care for acute shortness of breath, and many undergo~     computerized tomographic pulmonary angiography (CTPA) testing that is negative for acute~     disease. Management of patients with persistent shortness of breath despite normal testing~     continues to pose a challenge for clinicians. Right ventricular (RV) failure is a common~     cause of dyspnea that brings patients to the emergency department (ED), however, it is often~     not considered in the differential diagnosis, remains unrecognized, or patients are not~     properly followed up once diagnosed. Delays in diagnosis and management of RV failure are~     associated with poor outcomes. The investigators propose a novel clinical pathway, which~     entails identifying and enrolling patients with RV failure in the ED, then referring them to~     a specialized cardiovascular clinic where they will receive a standardized evaluation and~     management plan. Our hypothesis is that management of RV failure, through this pathway, will~     improve patient outcomes when compared to standard care. The primary outcome will assess~     1-year unscheduled healthcare visits.~   "
37666|NCT03073616|"~     This study will be conducted to determine the advantages and limitations of sonography~     compared with chest radiography, in the detection of post procedure iatrogenic pneumothorax~     in patients underwent to Pectus Excavatum (PE) with Nuss repair.~   "
37667|NCT03073603|"~     Natural history research in MS suggests that risk of relapses and new Magnetic Resonance~     Imaging (MRI) changes diminish significantly as people age, especially in MS patients 55 or~     older. Thus, the need to continue MS medicines that reduce relapses and new MRI lesions may~     also decrease as people age, especially in those who have not had relapses or MRI scan~     changes for prolonged times. This study plans to learn more about the safety of stopping MS~     medication in this population, as compared to continuing on the medication.~   "
37668|NCT03073590|"~     The current study is aimed at evaluating nutrition interventions to be implemented for~     improving health and nutritional status of female garments workers in 4 selected garment~     factories in Bangladesh. The interventions will attempt to increase either energy intake and~     or iron intake by female garments workers and expected to implement the interventions as~     planned:~        1. Provision of a once weekly iron/folate supplement, and nutritionally improved, daily hot~          lunch including multi-nutrient fortified rice plus a nutrition and health behavior~          change communications (BCC) program in intervention factory compared with a control~          factory which will provide regular lunch meal plus a nutrition and health behavior~          change communications (BCC) program for 10 months~        2. Provision of a twice weekly iron/folate supplement plus a nutrition and health BCC~          program in an intervention factory compared with a control factory with only nutrition~          and health BCC program for 10 months; on the following outcomes:~             -  Prevalence of anemia~             -  Nutrition knowledge and practices as per key messages of the BCC program~             -  Worker satisfaction with the modified lunch and/or iron/folate supplementation, and~               the BCC program~   "
37669|NCT03073577|"~     Islet Transplantation is a procedure used in people with difficult to control Type 1~     Diabetes. Insulin producing cells (islets) are isolated from a deceased donor pancreas. After~     the cells are carefully isolated from the donor pancreas, the islets are transplanted into~     the recipient's liver. These transplanted islets may produce insulin.~      One of the challenges with islet transplant is the death of some of the transplanted islets~     due to inflammation, oxidative stress and exposure to diabetogenic immunosuppressive agents~     associated with islet functional impairment and graft loss, especially linked to the use of~     calcineurin inhibitors, including tacrolimus (Tac).~      Antiaging glycopeptide (PKX-001) is a small, stable, synthetic replica of antifreeze proteins~     (AFPs), which naturally occur in Arctic and Antarctic fish and have been shown protecting~     cells against harmful conditions. PKX-001 is a new drug that has been shown in lab studies to~     help islet cells survive isolation and keep them healthy and functioning. Most importantly,~     animal studies have shown that islets treated with PKX-001 were protected from the~     immunosuppressant (Tac) toxicity and retained their function in animals receiving islet~     transplant.~      This study will involve up to 10 participants from the islet transplant waiting list at the~     Clinical Islet Transplant Program. All participants will receive islets treated with the~     medication PKX-001. PKX-001 will be used only in the islet preservation process, and will not~     be given to participants as medication.~      The purpose of this study is to confirm the safety of transplantation of PKX-001 treated~     islets and to evaluate the cytoprotective capacity of PKX-001 in islet transplantation,~     especially its capacity to protect against Tac induced graft dysfunction.~   "
37670|NCT03073564|"~     The study will evaluate the effect of positive airway expiratory pressure (EPAP) on patients~     with chronic obstructive pulmonary disease (COPD) during submaximal upper limb exercise.~   "
37671|NCT03073551|"~     Gestational diabetes mellitus (GDM) affects up to 3-5% of all pregnancies. When diagnosed~     with GDM, women undergo nutritional counseling, blood sugars monitoring and are encouraged to~     exercise regularly. Women who do not meet therapeutic targets may need to add insulin~     injections. Activity promoting video games are an attractive possibility for improvement of~     exercise compliance. The objective of this study is to determine whether providing women~     recently diagnosed with GDM with a Nintendo Wii™ activity promoting gaming platform will~     increase activity levels, improve glycemic control of sugar levels and decrease the need for~     supplementary insulin treatment.~   "
37672|NCT03073538|"~     Untreated maternal infection with gonorrhea and/or chlamydia can have serious complications~     in pregnancy and the neonatal period. In Ontario, routine screening for these infections is~     done in the first trimester of pregnancy, positive cases are treated with antibiotics, and~     all newborns are given antibiotic eye ointment within 24 hours of birth. Recently, the~     Canadian Pediatric Society recommended stopping universal prophylaxis for newborns, with~     instead, focus on screening and treatment of these infections in pregnancy. Given that these~     infections can occur at any time in pregnancy, and exposure at delivery provides a~     significant risk to infants, more information is needed about the rates of infection~     throughout pregnancy and health-care provider compliance with guidelines to make this change~     without undue risk. With this information optimal timing of testing can be evaluated.~   "
37673|NCT03073525|"~     This is a crossover study of Vigil, Atezolizumab and their combination in patients who have~     tumor harvested at surgery and successful manufacturing of Vigil but are ineligible for~     CL-PTL-119 (the VITAL study) or previously randomized to placebo.~   "
37674|NCT03073512|"~     Preterm birth still remains a major cause of perinatal morbidity and mortality worldwide. The~     exact mechanism stimulating term and preterm births in humans is still unknown.~     Prostaglandins, by mediating cervical ripening and early stimulation of myometrial~     contractions, are likely to play a major role in the parturition process. Much of the unique~     fetal circulation is facilitated by the ductus arteriosus. Patency of the ductus arteriosus~     in utero is primarily maintained via prostaglandins which are highly expressed by smooth~     muscle cells located in the media of the ductus arteriosus. The primary objective of this~     study is to prospectively assess whether any changes in the fetal ductus arteriosus~     parameters exist at 32 weeks' gestation. The secondary objective is to investigate whether~     there is an association between the ductus arteriosus parameters and the time to delivery~     interval at 32 weeks' gestation.~   "
37675|NCT03073499|"~     This pilot study aims to evaluate the sensitivity, variability and responsiveness of a number~     of predefined clinical and psychological outcome measuring tools in an ambulant cancer~     treatment setting (home vs. hospital). The measuring tools will be evaluated in two patient~     cohorts. One cohort is treated as per standard of care at the outpatient hospital, the other~     cohort is receiving (partial) cancer treatment at home. A second objective is to create a~     costs inventory representing total costs for an ambulant treated cancer patient.~   "
37676|NCT03073486|"~     The objectives of this study are to assess the safety and efficacy of Olumacostat Glasaretil~     Gel compared to vehicle in patients with acne vulgaris~   "
37677|NCT03073473|"~     Among patients with advanced (metastatic) cancers, detailed characterizations of the tumor~     utilizing genomic and proteonomic techniques may help guide treatment. It, however, remains~     unclear if these new diagnostic technologies truly influence clinical and economic outcomes.~     This study will evaluate if patients treated according to the results of the NantHealth GPS~     Cancer test achieve optimal outcomes compared to patients whose treatment are discordant with~     GPS Cancer recommendations.~   "
37678|NCT03073460|"~     The exact mechanism stimulating the parturition in humans is still relatively unknown.~     Prostaglandins, by mediating cervical ripening and early stimulation of myometrial~     contractions, are likely to play a major role in the parturition process. Much of the unique~     fetal circulation is facilitated by the ductus arteriosus. Patency of the ductus arteriosus~     in utero is primarily maintained via prostaglandins which are highly expressed by smooth~     muscle cells located in the media of the ductus arteriosus. The aim of the study is to~     prospectively observe fetal ultrasound changes related to the ductus arteriosus. The primary~     objective is to prospectively assess, whether any changes in the fetal ductus arteriosus~     parameters exist at 40 weeks' gestation. The secondary objective is to investigate whether~     there is an association between the ductus arteriosus parameters and the time to delivery~     interval at 40 weeks' gestation.~   "
37679|NCT03073447|"~     MI in elderly women seems to share the same pathophysiology than in men, especially plaque~     rupture associated with conventional risk factors. Therefore the questions is not solved on~     the pathophysiology and specific risk factors in young women whose prognosis is more severe.~     A complete descriptive analysis appears mandatory to understand the peculiarities, including~     not only morphological but also biological explorations as well.~      To date no systematic descriptive analysis has been performed including clinical~     characteristics, cardiac and extra-cardiac morphological exploration and hormonal and~     immunological assays, particularly in young premenopausal women presenting MI.~      This study will provide for the first time a complete analysis, including hormonal assays,~     never made in an acute population.~      The main objective of this clinical study is to systematically pool clinical, morphological~     and biological data of young women (< 50 years) presenting an Acute MI and to assess their~     short-term (in-hospital) and mid-term (12 months) prognosis. The definition of MI is the one~     adopted in the Third definition published in 2012. As such an event occurs in a young~     patient, diagnostic and treatment may vary among centres. The incidence of such cases in each~     centre being low and practice inhomogeneous, no conclusion could be advanced concerning the~     study of associated, indeed predisposing factors.~      The work aims to comprehensively and systematically collect all the clinical and laboratory~     data and the results of the all morphological explorations carried out during the care of~     these young women admitted for acute MI in high-volume centres.~      No additional invasive act, without any direct benefit for the care of patients will be~     realized for research purposes.~      All these examinations, in particular invasive morphological, are more and more integrated in~     the practice of modern interventional cardiology especially for complex or infrequent~     situations, like this setting. They afford accurate diagnosis of coronary disease on one hand~     and on the second hand they determine the causal or at least participating factor.~      A comprehensive and systematic analysis of this particular entity that is MI in young woman,~     would improve our knowledge of this disease and then enable to offer patients a more~     appropriate treatment and monitoring. It is necessary to progress in the understanding of the~     mechanisms of the early onset of coronary artery disease in its most acute and most serious~     presentation and to clearly define the specificities of coronary disease in young women.~     Moreover, a more precise identification of risk factors of MI in a woman under 50 will allow~     a better screening and even introduction of preventive strategies.~   "
37680|NCT03073434|"~     This is a retrospective study involving all patients with a history of renal transplant that~     attended antenatal clinics at various Toronto hospitals and subsequently delivered between~     January 2000 and December 2014.~      The purpose of this study is to describe the incidence of adverse pregnancy-and~     transplant-related outcomes, and report placental ultrasound and placental pathology findings~     in renal transplant recipients with contemporary standards of care in Toronto.~      This study also seeks to determine whether factors such as maternal age,~     transplant-to-pregnancy interval, hypertension, diabetes mellitus, treatment regimens, and~     the primary cause for renal failure are associated with higher risk of adverse pregnancy~     outcomes in renal transplant recipients.~   "
37681|NCT03073421|"~     The Positive Pregnancy Program is an innovative, unique, interprofessional model of care for~     HIV-positive pregnant women. This program has been in place at St. Michael's Hospital for~     five years. This study is important because it will allow for a critical evaluation of the~     Program, and to identify strengths and weaknesses. This will in turn provide the opportunity~     to improve delivery of care for HIV positive women.~   "
37682|NCT03073408|"~     The action of anesthetics such as propofol is not immediate after intravenous administration.~     Delay in pharmacodynamic effect of intravenous drugs is a commonly observed phenomenon in~     total intravenous anesthesia (TIVA). On the other hand, the measure of the clinical effect of~     propofol by EEG processed monitors like the bispectral index (BIS) also requires some~     processing time for the analysis of the recorded signal. Thus, the resulting BIS value~     provided by the monitor is affected by a delay. When a BIS based controller is used, the~     propofol infusion rates are defined using information of the BIS signal available. The delay~     in the BIS signal is an important issue as it can affect the performance of the controller.~     There are scarce contributions to address the delay in automatic administration of~     anesthesia.~      Our proposal to deal with the dead time in the control action of the hypnotic component of~     anesthesia is a proportional-integral (PI) algorithm with a Smith predictor. The aim of this~     study is to evaluate and compare the feasibility and effectiveness of a closed-loop control~     using the Smith predictor versus manual control for propofol administration guided by the~     bispectral index (BIS) in adults patients. The objective is to show that a closed loop~     control can be a useful tool to provide safe and effective intravenous anesthesia and that~     the use of specific controller for delay rejection is a reliable strategy.~   "
37683|NCT03073395|"~     An early phase I study to evaluate the uptake of [68Ga]P16-093 in known or suspected~     metastatic prostate or renal cancer to establish the feasibility of using [68Ga]P16-093 to~     image PSMA expressing cancer. Measurement of the whole body biodistribution of [68Ga]P16-093~     in man to generate human radiation dosimetry data.~   "
37684|NCT03073382|"~     This is a chart review of all patients who have underwent open prenatal repair of fetal~     myelomeningocele. Although prenatal repair is associated with improved neurologic outcomes~     and a decreased need for cerebrospinal fluid shunting after birth, one of the major risks is~     preterm delivery. This study is intended to identify maternal, fetal or intraoperative risk~     factors associated with preterm delivery.~   "
37685|NCT03073369|"~     The purpose of the study is to learn more about how treatment with vitamin D can affect iron~     metabolism and blood levels of hepcidin (hormone controlling iron levels) in people with~     chronic kidney disease (CKD).~      Iron is an essential mineral which is a major component of proteins that carry oxygen in the~     blood. Problems with iron metabolism can lead to low blood levels (anemia), which can~     commonly happen in people with CKD.~      New research over the last decade has uncovered a new hormone called `hepcidin', which is~     made in the liver and released into the blood. Hepcidin controls how much iron is in the~     blood by preventing the absorption of iron from food. Blood levels of hepcidin C are found to~     be high in people with CKD, and a recent small study in people with normal kidney function~     showed that treatment with vitamin D decreased hepcidin levels.~      In this study, investigators would like to examine the effects of vitamin D (Ergocalciferol)~     on iron metabolism and blood levels of hepcidin in individuals with CKD.~   "
37686|NCT03073356|"~     Ketones may have beneficial effects on myocardial metabolism and hemodynamics. In the present~     study, healthy test subjects and patients with heart failure with reduced ejections fraction~     will be investigated in a randomized cross-over design with ketone infusions and placebo.~     Myocardial efficiency and hemodynamics will be evaluated.~   "
37687|NCT03073343|"~     Betaine (trimethyglycine) is a food supplement that is approved for sale in the United States~     without a prescription. In this study, betaine will be provided to patients as a powder that~     can be mixed with aqueous solutions and consumed orally.~   "
37688|NCT03073330|"~     Our study will assess if there is a difference in incidence of gestational diabetes using~     different screening approaches, either using a one-step approach with a 2 hour glucose~     tolerance test or using a two-step approach. Prior studies have proven similar incidences~     including a randomized controlled trial.~   "
37689|NCT03073317|"~     Investigators will test a novel system of integrated care, to promote the use of the WORLD~     HEALTH ORGANIZATION Guidelines for the management of pre-eclampsia and initiate the use of a~     structured risk assessment strategy to reduce the incidence of preterm delivery from~     pre-eclampsia by providing obstetricians with the confidence to safely defer delivery of~     women with pre-eclampsia, identified to be of low risk.~   "
37690|NCT03073304|"~     The primary aim of this study is to investigate the possibility to replace an erythrocyte~     based prime solution with a crystalloid based prime solution while maintaining metabolic~     function. Secondary also to study if potentially reduced immunological influence is obtained~     during hyper thermic isolated limb perfusion with a crystalloid based prime solution.~   "
37691|NCT03073291|"~     The legalization of recreational marijuana use and sales in Alaska, Colorado, Oregon, and~     Washington State is a dramatic change in U.S. substance abuse policy that places a priority~     on developing regulatory and enforcement systems that prevent distribution of retail~     recreational marijuana to minors. Responsible marijuana vendor training, modeled after~     effective responsible alcoholic beverage training, has the potential to help the states~     prevent distribution to minors. This research will produce a responsible marijuana vendor~     training provided by a third party, not the cannabis industry, and test its effectiveness~     with retail recreational marijuana licensees and employees in Colorado, Oregon, and~     Washington State.~   "
37692|NCT03073278|"~     To examine the feasibility, safety and toxicity of focal stereotactic radiation treatment~     (SBRT) for locally recurrent prostate cancer.~   "
37693|NCT03073265|"~     The objective is to demonstrate the performances of STA® - Apixaban Calibrator & STA® -~     Apixaban Control used in combination with STA® - Liquid Anti-Xa to measure apixaban~     concentration in plasma. Anti-Xa results will be compared to LCMS (liquid chromatography -~     mass spectrometry) for validation of the assay. For this study, the anti-Xa assay will be~     performed on fresh samples only.~      The results will be used to complete results obtained previously on frozen samples.~   "
37694|NCT03073252|"~     The primary purpose of this study is to explore the effect of high versus normal egg-based~     protein meals on acute exercise-induced elevated blood pressure.~   "
37800|NCT03071848|"~     This study will evaluate the safety of bevacizumab (Avastin®) combined with standard~     chemotherapy in participant with advanced cervical cancer, with special focus on the~     incidence of gastrointestinal (GI) and genitourinary (GU) fistulas and GI perforations in the~     common practice setting.~   "
37695|NCT03073239|"~     Amyotrophic Lateral Sclerosis (ALS) is a degenerative neuromuscular disease, progressing~     inexorably to respiratory failure, the by involvement of respiratory muscles, the commitment~     with most impact on the prognosis of ALS.~      According to current knowledge, the clinical presentation of the disease is characterized by~     spinal or bulbar involvement, the latter being associated with a worse prognosis.~      There are multiple factors described in the aetiology of ALS, as the successive damage the~     motor neuron, which can happen in high-impact athletes, or exposure to heavy metals. Genetic~     mutations are also described, being associated to a higher prevalence of ALS.~      Data from retrospective studies with ALS populations reveal a prevalence of 4-8 cases per~     100,000 persons. Research carried out in Trás-os-Montes e Alto Douro region (Northeast of~     Portugal) shows a high prevalence of ALS, with near 10 cases per 100,000 persons, with a~     recent increase in the bulbar involvement. The reasons for the high prevalence of ALS in this~     region are unknown.~   "
37696|NCT03073226|"~     Barrett's oesophagus is a condition where the lining of the oesophagus (gullet) wall changes.~     People with Barrett's oesophagus are at risk of developing oesophageal cancer but can have~     regular checkups to detect changes before they progress to cancer. Every two years patients~     with Barrett's are offered examination by passing a fibreoptic tube into the oesophagus~     (gastroscopy) to remove small tissue samples (biopsies), which are examined in the laboratory~     to check for changes.~      Bowel cancer is the third most common cancer in the UK, and the second leading cause of~     cancer deaths. Prevention and early detection are the most effective strategies of dealing~     with bowel cancer. Most cancers develop from benign polyps (growths) in the bowel. Polyps are~     common and have the potential of developing into cancer over the course of many years.~      Patients with a prior diagnosis of Barrett's oesophagus and colonic polyps undergo regular~     endoscopic examinations known as surveillance endoscopies. This is done to detect changes in~     the cells of Barrett's oesophagus or further polyps. Current practice is to capture recorded~     videos of Barrett's surveillance examinations and still images of polyps prior to their~     removal.~      Endoscope technology continues to advance. These newly developed technologies are marketed to~     have claims of superiority in performance over preceding generations often without the back~     up of scientific data but at a significant financial cost. The aim of this study is to use~     endoscopic images and videos recorded as part of routine clinical practice to compare the~     current version of Olympus endoscopes with the new version launched by the company.~   "
37697|NCT03073213|"~     The purpose of the study is to research how much ixekizumab enters the bloodstream and how~     long the body takes to get rid of the drug and the safety of ixekizumab and any side effects~     that might be associated with it. The study has two parts: A single-dose part and~     multiple-dose part. The single dose part of this study will last up to 24 weeks, including~     the screening period. The multiple dose part of this study will last up to 32 weeks including~     the screening period.~   "
37698|NCT03073200|"~     The purpose of this study is to evaluate the safety and efficacy of ixekizumab in pediatric~     participants with moderate-to-severe plaque psoriasis.~   "
37699|NCT03073187|"~     The overall goal of this project is to develop and to preliminarily validate a novel~     intervention to be delivered in the high school setting that integrates two evidence-based,~     school-based interventions for urban adolescents with proven efficacy: (1) Asthma~     Self-Management for Adolescents (ASMA), an intervention for adolescents with uncontrolled~     asthma and (2) the Sleep-Smart Program (Sleep-Smart), which focuses on sleep hygiene and~     behaviors in urban adolescents.~      The aim for Phase I is to develop and integrate school-based interventions to improve asthma~     self-management and sleep hygiene in urban high school students via interviews.~      The aims for Phase II are: (1) to evaluate the feasibility and acceptability of the~     intervention procedures; and (2) to assess the preliminary evidence of the effects of the~     intervention on improving sleep quality in urban high school students with persistent asthma~     over a 2-month follow-up period.~      This record is for Phase I only.~   "
37700|NCT03073174|"~     A previous study, on which this study is based, found that a diet higher in fruits and~     vegetables, beta-carotene, vitamin C, alpha-tocopherol, and fish oils (specifically~     eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)) was positively associated with~     periodontal healing after sanative therapy (NCT02291835). The investigator's next step, in~     the present study, is to determine long-term benefits of sanative therapy in which patients~     have regular maintenance hygiene cleanings on periodontal health. Specifically, the~     relationship between intakes of specific foods, nutrients and supplements with clinical~     periodontal outcomes will be studied.~   "
37701|NCT03073161|"~     Periodontitis is a chronic inflammatory disease that, if untreated, will lead to tooth loss.~     To treat periodontal disease, sanative therapy is used as a first line cost-effective~     strategy to manage periodontal disease and thus prevent tooth loss. Diet is emerging as a~     modifiable factor that may help an individual to more fully respond to treatments such as~     sanative therapy. Dietary flavonoids, abundant in fruits and tea, may be particularly~     beneficial. Patients with moderate to severe chronic generalized periodontitis and undergoing~     sanative therapy will be recruited for the study. Mean clinical attachment loss as well as~     other clinical measures will be assessed at baseline and 8 to 12 weeks following sanative~     therapy to measure periodontal healing. At baseline and follow-up appointment, the following~     will be assessed to examine associations with clinical measures of periodontal healing:~     intakes of macronutrients and micronutrients, fruits, vegetables and tea as well as~     supplement use and salivary markers of inflammation.~   "
37702|NCT03073135|"~     This study aims to evaluate the effectiveness of psychodrama group therapy (PGT) compared~     with supportive group therapy (SGT) for excoriation disorder (ED). Patients will be randomly~     allocated for either PGT or SGT. The Skin Picking Scale Revised (SPS-R) will be the primary~     outcome and emotional regulation measured by the Difficulties in Emotion Regulation Scale~     (DERS) will be evaluated as a potential intermediator. The Clinical Global Impression Scale~     (CGI); Beck Depression Scale (BDI); Beck Anxiety Scale (BAI), and the Social Adjustment Scale~     (EAS) will assess secondary outcomes.~   "
37801|NCT03071835|"~     A comparative study to follow subjects who received stem cell therapies three, five, seven,~     and nine years after their follow-on visit. Subjects will be selected from a pool of previous~     Interdisciplinary Stem Cell Institute trial participants.~   "
37703|NCT03073122|"~     In the landmark Boston Circulatory Arrest Study, neurologic and developmental status was~     measured following infant heart surgery and then prospectively at ages 1, 2.5, 4, 8, and 16~     years, with findings of significant neurocognitive deficits and brain MRI abnormalities~     regardless of operative management. To date, no study has evaluated the neuropsychological~     and neuroimaging antecedents and correlates of well-being in adults with congenital heart~     disease, a population now >1 million and projected to grow at 5% per year. The investigators~     propose to study the Boston cohort at ages 24-29 years to assess the associations of adult~     well-being with childhood and adolescent executive function, other measures of mental health~     and cognitive function, adolescent brain MRI findings, and clinical variables; findings will~     guide the design of interventions in childhood to optimize outcomes in adults with congenital~     heart disease.~   "
37704|NCT03073109|"~     This study is aimed to describe the outcomes related to physical activity, activity of~     disease, quality of life, work productivity and safety in Latin-American patients with~     Rheumatoid Arthritis (RA) treated with tofacitinib or biological DMARDs after failure to~     respond to conventional DMARDs in real-life conditions. This will be a non-interventional,~     hybrid study (prospective and retrospective data collection) comparing tofacitinib to~     biologic DMARD treatments in patients with RA after failure of conventional DMARDs. The~     population will be composed by adult patients over 18 years of age diagnosed with RA and who~     have been prescribed tofacitinib or any biological DMARDs.~   "
37705|NCT03073096|"~     Lymphedema is the build-up of lymph fluid in the body's tissue causing chronic, debilitating~     swelling. This commonly occurs as a result of a disruption of the lymphatic system during~     lymph node dissection surgeries. In melanoma patients, the incidence of lymphedema ranges~     from 5-10% in the arms following an axillary dissection, and 28-40% in the legs following~     groin dissection. LYMPHA (LYmphatic Microsurgical Preventive Healing Approach) is an~     innovative microsurgical technique where blocked lymphatic vessels are drained into the blood~     circulation by surgically creating a shunt between a lymphatic channel and a blood vessel~     called a lymphatic-venous bypass. Recently, LYMPHA has been shown to prevent lymphedema when~     performed at the time of nodal dissection. We propose a prospective pilot study evaluating~     the practice of the LYMPHA technique for the primary prevention lymphedema at The Ottawa~     Hospital. The novel use of the LYMPHA technique holds the potential to prevent lymphedema~     rather than to attempt to treat it once it has already progressed and as a result will not~     only improve the quality of life of the cancer patients, but also decrease health care costs~     associated with treating lymphedema.~   "
37706|NCT03073083|"~     A rupture of the anterior cruciate ligament (ACL) is a severe injury of the knee. The current~     gold Standard treatment for young and active patients with instability, is a surgical ACL~     reconstruction. However, there still is no consensus on which graft is best suited for~     this.The aim of the current multi-center randomized controlled trial was to investigate the~     hypothesis that an anatomic single bundle anterior cruciate ligament reconstruction with a~     (flat) quadriceps tendon autograft is at least as effective as reconstruction of the ruptured~     anterior cruciate ligament with a patella tendon autograft or a hamstringtendon autograft, in~     terms of failure, measured 2 years postoperatively. Failure is defined gedefinieerd as~     pathologicai laxity, complaints of knee instability in the absence of any pathological laxity~     and/or discontinuïty ofthe graft on MRl or arthroscopy.~   "
37707|NCT03073070|"~     HbA1c, a measure of mean blood glucose over the lifespan of a red blood cell (RBC), is a~     marker of increasing importance both for assessing glycemic control in children with known~     diabetes and for the diagnosis of diabetes in children. HbA1c has demonstrated poor~     reliability in diagnosis and management of pediatric diabetes and the most plausible reason~     for this unreliability is that the reference ranges of HbA1c were established based on~     120-day RBC lifespan observed in adults, without considering the RBC lifespan difference~     between children and adults. The proposed studies will for the first time determine RBC~     lifespan in diabetic children~   "
37708|NCT03073057|"~     The purpose of this study is to compare Budesonide/formoterol Easyhaler test products with~     the marketed product Symbicort Turbuhaler in terms of the drug absorbed into the bloodstream.~   "
37709|NCT03073044|"~     The BELA-P-k was translated from Dutch into Italian. Subsequently 102 patients with PD filled~     out the questionnaire~   "
37710|NCT03073031|"~     This study evaluates if melanoma patients who report their side effects to immunotherapy~     weekly by the use of ePRO-CTCAE will experience an overall reduction of grade 3 and 4 events~     with 50% compared to routine monitoring carried out every 3 weeks.~   "
37711|NCT03073018|"~     The Prevention of Renal and Vascular Endstage Disease Intervention Trial (PREVEND IT) was~     designed to determine whether intervention with the angiotensin-converting enzyme (ACE)~     inhibitor fosinopril and/or the hydroxymethylglutaryl coenzyme A reductase inhibitor~     pravastatin reduced cardiovascular and renal events in nonhypertensive,~     nonhypercholesterolemic subjects with microalbuminuria.~   "
37712|NCT03073005|"~     This study will evaluate the performance of a curriculum using medical simulators to train~     patients with advanced heart failure and their caregivers to master the self-management of~     ventricular assist devices (a device implanted into the heart to help circulate the blood).~     The investigators expect this training will improve self-management skills, and reduce~     VAD-related infections and re-hospitalizations. In addition to providing innovative training~     to the patients and their caregivers, the study will advance our knowledge of the effects of~     simulation-based training on patient self-management and safety.~   "
37726|NCT03072823|"~     N-3 polyunsaturated fatty acids(N-3 PUFAs) is important in balancing the immune function and~     physical health by reducing membrane arachidonic acid (AA) and prostaglandin E2 (PGE2)~     synthesis, which might be linked to the somatic manifestations physical morbidity, such as~     Cardiovascular disease in depression. n-3 polyunsaturated fatty acids appears to be a~     promising treatment that is safe, beneficial to patients with Cardiovascular disease and~     depression. In this proposal, investigators aim the test the hypothesis that n-3~     polyunsaturated fatty acids will be more effective than placebo in treating Cardiovascular~     disease patients with major depression after 12 weeks of intervention.~   "
37804|NCT03071796|"~     In this study the investigator will evaluate whether a liquid multivitamin supplement~     influences blood and vital parameters. Furthermore the investigator will establish the~     effects on life quality, mood and perception of stress and will characterize changes on~     immune system.~   "
37713|NCT03072992|"~     The aim of this study is to assess benefits of treatment with intravenous Curcumin® (CUC-01)~     vs placebo, in combination with paclitaxel chemotherapy, and to estimate the risk of adverse~     events in patients with locally advanced and metastatic breast cancer.~      This is a randomized, double-blind, placebo-controlled, two arms parallel group phase 2~     clinical trial:~      Group A, 75 patients, treatment with Curcumin (CUC-01, yellow solution), 300mg i.v. plus i.v.~     Paclitaxel (colorless solution) 80 mg /m2 BS i.e., once weekly for 12 weeks.~      Group B, 75 patients, treatment with Paclitaxel (colorless solution) 80 mg /m2 BS, i.v. plus~     placebo i.v. solution (250 ml, yellow solution for masking/blinding), once weekly for 12~     weeks.~      Primary objective of the study:~      To assess:~        -  Efficacy of combined therapy with Curcumin ®, (CUC-01) and Paclitaxel vs Paclitaxel in~          patients with advanced and metastatic breast cancer in terms of Objective Response Rate~          (ORR) assessed with the Modified Response Evaluation Criteria In Solid Tumours (RECIST).~      Secondary objectives of the study:~      To assess:~        -  The safety of Curcumin+Paclitaxel combination compared to Paclitaxel+placebo treatment~          by assessment of adverse effects.~        -  Quality of life (QOL) in patient treated with Curcumin+Paclitaxel combination compared~          to Paclitaxel+Placebo~        -  Response duration in terms of Progression free survival (PFS), Time to Disease~          Progression (TTP) and Time to treatment failure (TTTF)~   "
37714|NCT03072979|"~     Pre-clinical evidence suggests that radiotherapy reduces tumour-associated vasculature. The~     investigators will conduct a single-arm prospective study to quantify the reduction in tumour~     vasculature post-radiotherapy~   "
37715|NCT03072966|"~     Distress monitoring is an important issue in cancer survivors. However, conventional distress~     screening is very difficult to perform. This study investigates the efficacy of wearable~     device as a tool of distress monitoring in breast cancer survivors.~   "
37716|NCT03072953|"~     The purpose of this Phase 2a, open label, proof-of-concept clinical study is to assess the~     efficacy and safety of etrasimod (APD334) in patients with Pyoderma Gangrenosum.~   "
37717|NCT03072940|"~     Idiopathic rapid eye movement sleep behavior disorder (iRBD) is characterized by nocturnal~     violence, increased muscle tone during REM sleep and the lack of any other neurological~     disease. However, iRBD can precede parkinsonism and dementia by several years. The causes of~     the loss of muscle atonia during REM sleep in these patients are unclear. Using 3 T MRI and~     neuromelanin- sensitive sequences, the signal intensity was previously found to be reduce in~     the locus coeruleus/subcoeruleus area of patients with Parkinson's disease and RBD. Here, the~     investigators aimed at studying the integrity of the locus coeruleus/ subcoeruleus complex~     with neuromelanin-sensitive imaging in 21 patients with iRBD and compared the results with~     those from 21 age- and gender-matched healthy volunteers. All subjects will undergo a~     clinical examination, motor, cognitive, autonomous, psychological, olfactory and color vision~     tests, and rapid eye movement sleep characterization using video-polysomnography and 3 T~     magnetic resonance imaging.~   "
37718|NCT03072927|"~     This prospective longitudinal study will compare incidence rates of Medicare beneficiary~     surgical and minimally invasive intervention post index procedure, as well as harms~     associated with the MILD procedure, at 24 months post-treatment with MILD, tested against a~     control group of similar patients that have had a comparable procedure.~   "
37719|NCT03072914|"~     In the present study, we evaluated whether RIPC with RIPostC reduce the major~     neurocomplication in patients undergoing STA-MCA anastomosis.~   "
37720|NCT03072901|"~     The purpose of the registry was to observe the safety and effectiveness outcomes for subjects~     treated with the EndoBarrier in the post market setting where the product had Conformité~     Européene (CE mark) regulatory approval and in accordance to the approved Indication For Use.~   "
37721|NCT03072888|"~     The purpose of this study is to evaluate the effect of Transcutaneous Electrical Nerve~     Stimulation (TENS) in patients after abdominal hysterectomy surgery.~   "
37722|NCT03072875|"~     The overarching goal of this research is to create a tool that could reduce suicide rates,~     increase delivery of efficacious suicide interventions, and decrease overall costs associated~     with suicidal behaviors. With this in mind, investigators intend to: (1) develop and~     scientifically validate a relational agent for suicidal patients that delivers Collaborative~     Assessment and Management of Suicidality (CAMS), an efficacious and cost-effective~     intervention developed by David Jobes, PhD; and (2) to create an integrated software system~     (CAMS Relational Agent System; CAMS-RAS) that assists medical personnel by synthesizing the~     CAMS intervention findings into an easy-to-interpret report, providing empirically-derived~     clinical decision support; (3) enhances the patient's coping capability by including~     psychoeducational skills training modules for use during and after hospitalization; and (4)~     automates the delivery of caring contacts, an efficacious and brief suicide prevention~     intervention provided after discharge. The focus of participant recruitment will be Emergency~     Departments (EDs), often the initial point of contact and where personnel must make the~     decision whether to hospitalize or discharge the suicidal patient. Investigators will also~     conduct testing in other medical and outpatient mental health settings to ensure public~     health impact and commercial success.~      Phase I project aims include: (1) creating an advisory board to guide the development of~     CAMS-RAS; (2) iteratively design and develop relational agent (Dr. Dave) modeled after the~     gestures, expressions, and mannerisms of CAMS treatment developer, David Jobes, PhD; and (3)~     conduct feasibility tests to determine whether CAMS-RAS is acceptable, easy to use, and liked~     by target end-users: acutely suicidal patients admitted to hospital EDs, psychiatric~     inpatient units, and medical floors for treatment of injuries sustained during a suicide~     attempt; hospital medical personnel, administrators, and other stakeholders including peer~     advocates; and outpatient suicidal patients, clinicians and administrators.~   "
37723|NCT03072862|"~     The purpose of this study is to show that cochlear implant treatment improves the overall~     health related quality of life and general well-being in elderly individuals.~   "
37724|NCT03072849|"~     This study aims to determine whether or not early spirometric detection and management of~     obstructive lung disease with combined fluticasone/azithromycin/montelukast therapy (FAM) can~     attenuate declining lung function, prevent the development of bronchiolitis obliterans, and~     improve patient outcomes following hematopoietic stem cell transplant.~   "
37725|NCT03072836|"~     The FLORACROHN project aims to compare gut microbiota of patients suffering from Crohn's~     disease (CD) associated or not to spondylarthritis (SpA).~      3 groups of patients will be analyzed: patients suffering from CD alone, patients suffering~     from SpA alone, patients suffering from CD and SpA.~      Fecal microbiota will be determined by 16SRNA gene sequencing.~   "
37802|NCT03071822|"~     The PIGLETS regimen was devised to replace the conventional SMILE regimen in management of~     extranodal NK/T cell lymphoma in our institution. It had been three years since the~     introduction of PIGLETS regimen in treatment of NK malignancies. The response rate is~     encouraging, with an overall response rate (ORR) of 90% in NK malignancies. Side effects are~     generally tolerable. The investigator therefore propose the use of PIGLETS on newly diagnosed~     or relapsed/refractory PTCLs.~   "
37727|NCT03072810|"~     This study aims to increase the well-being of individuals with chronic pain through a 4-week~     online positive mindfulness programme. Each module, lasting 4 days, will include a daily~     meditation and focus on a different aspect of positive psychology. This is a quantitative~     study. The independent variable is participation in the programme. The dependent variables~     are: wellbeing, mindfulness, pain severity, pain catastrophising and health quality of life.~     There will be one experimental group who participate in the programme as soon as they are~     recruited. There will be one control group who are put on a 'wait-list' to complete the~     programme after an 8 week wait. Pre and post measures will be taken. Participants are being~     recruited through NHS clinics in London and Oxford, including the Pain Management Centre at~     Oxford University Hospitals (Churchill site) and INPUT at St Thomas's Hospital (which are~     participant identification centres). Participants who hear about the study via other means~     including online or through word of mouth are also being accepted.~   "
37728|NCT03072797|"~     The Beijing Hospital Atherosclerosis Study (BHAS) is a prospective, single-center,~     observational cohort study performed at the Beijing Hospital in Beijing, China. Subjects~     enrolled in this study will be the consecutive patients undergoing coronary angiography in~     the hospital. Blood samples are taken immediately before the angiographic procedure. Clinical~     and angiographic characteristics are recorded. All patients will have routine follow-up at 6~     months and 1 year postprocedure, then yearly thereafter. Follow-up includes mortality,~     myocardial infarction (MI), stroke, rehospitalization, coronary revascularization procedures,~     life styles, and medication use. The primary end point for the study will be the major~     adverse cardiovascular events (MACE), defined as death from any cause, nonfatal myocardial~     infarction, nonfatal stroke and revascularization. This study has been reviewed and approved~     by the Ethics Committee of Beijing Hospital. All enrolled individuals will be received~     written notice of the intended use of their blood samples and provided written consent.~      The major objectives of the BHAS Study are to (1) establish a prospective cohort and a~     biological sample bank in ethnic Chinese with coronary angiography, (2) identify baseline new~     biosignature profiles such as novel biomarkers via metabolomics approach associated with the~     subsequent clinical events, (3) assess the use of molecular profiles from multiple platforms~     (eg, genomics, proteomics, and metabolomics) integrated with readily available clinical~     information for improved risk classification for cardiovascular events, and (4) provide~     clearer understanding of underlying disease processes.~   "
37729|NCT03072784|"~     Does the duration of cardiopulmonary bypass, and aortic cross clamping affects the post~     operative pulmonary function.~   "
37730|NCT03072771|"~     Based on the further need to improve progression-free survival (PFS) and overall survival~     (OS) post autologous stem cell transplant (SCT) for DLBCL, the hematopoietic profile of~     patients following auto-SCT, the activity of blinatumomab in DLBCL and its favorable toxicity~     profile, the investigators propose a pilot study to test blinatumomab as consolidation~     therapy post auto-SCT for patients with DLBCL.~      The investigators hypothesize the blinatumomab consolidation will optimize the effector to~     target (E-T) ratio and aid in the eradication of remaining tumor cells, leading to decreased~     relapse and increased overall survival. In addition, since tumor burden will be at a minimum,~     infusional toxicities including neurologic toxicities may also be limited. The purpose of~     this pilot study is to study the feasibility and tolerability of blinatumomab consolidation~     post auto-SCT for patients with chemo-sensitive DLBCL undergoing auto-SCT.~   "
37731|NCT03072758|"~     Breastfeeding remains the optimal mode of feeding for infants younger than six months.~     Exclusive Breast Feeding (EBF) among HIV-infected mothers has been shown to be associated~     with a sustained and significant reduction in HIV transmission and has the potential to~     reduce infant and under-five mortality.~      Given the considerable authority among men as decision makers in sub-Saharan African, we may~     be witnessing a missed opportunity to engage men in the education, awareness, and~     decision-making for EBF. Understanding the role and impact of male partners on this~     decision-making process require further examination to inform the development of effective~     and sustainable evidence-based interventions to support the initiation and sustainment of~     EBF.~   "
37732|NCT03072745|"~     The aim of the present study is to examine cognitive function in a patient population with~     complex chronic pain to test the hypothesis that insomnia severity on its own predicts~     objective cognitive function, and that a correlation is not better explained by comorbid~     depression or anxiety, morphine equivalent daily dose, or the level of pain itself.~   "
37733|NCT03072732|"~     The purpose of this study is to measure the fluid changes in the body using a device called~     the µ-Cor System, an investigational device. The µ-Cor System will record the fluid changes~     in the body, as well as ECG (electrocardiogram or an electrical tracing of your heart rhythm)~     heart rate, breathing rate, posture and activity at regular intervals.~      The information collected by the µ-Cor System will then be compared to the actual fluid~     removed through dialysis and to the information collected by an FDA (Food and Drug~     Administration) cleared device called ZOE (NonInvasive Medical Technologies), a monitor which~     also measures the fluid changes in the body.~      The objectives of this study are to document any differences in measurement of thoracic~     impedance obtained from the µ-Cor System and the ZOE system. Thoracic impedance is a measure~     of the electrical activity in the chest that varies with changes in body size and~     composition, fluid volume, breathing status and other variables.~      Measurements of the amount of fluid removed during dialysis will also be compared between the~     µ-Cor System, the ZOE system and the actual fluid removed.~      The ability of the µ-Cor System to measure thoracic impedance will be tested by placing the~     device randomly at one of two locations:~        -  Study Arm 1: side location- below left armpit~        -  Study Arm 2: front location - upper front chest~      Both the µ-Cor System and the ZOE System will be worn simultaneously during one dialysis~     session. The ZOE system device is placed on the chest- 2 points: 1 at the base of your neck~     and 1 in your mid chest.~   "
37734|NCT03072719|"~     A randomised, examiner blind, two treatment arm, stratified, parallel design, single-site~     study in subjects with at least two sensitive teeth to compare the efficacy of a test~     dentifrice against that of a control dentifrice in reducing dentinal hypersensitivity.~   "
39991|NCT03043261|"~     EMERGE is a PI-initiated feasibility study that aims to evaluate the accessibility,~     usability, effectiveness and relevance of an integrated psycho-behavioral intervention on~     heart failure patients in order to increase support, outreach and general well-being of these~     patients following hospitalization due to heart failure exacerbation.~   "
37735|NCT03072706|"~     Total hip replacement is one of the most successful surgical procedures of modern times, with~     over 80,000 performed each year in the UK. However, up to 5% of all primary hip replacements~     need to be revised within the first 10 years, and in many cases malposition of the acetabular~     (hip socket) component is implicated in the early failure.~      The standard method of positioning the acetabular component is for the surgeon to be guided~     by a combination of the visible anatomical landmarks within the surgical field, and the wider~     environment of the operating theatre. The advent of 3D printing has led to the development of~     custom-made surgical guides which can be used during surgery, in order to assist the surgeon~     in the positioning of instruments and devices. These surgical guides are manufactured based~     on CT or MRI imaging, and are designed to clearly indicate to the surgeon the desired~     location and orientation of bony cuts and implant positions.~      This study will test the hypothesis that an acetabular alignment guide combined with~     three-dimensional CT-based planning using the Corin OPS™ (Optimised Positioning System),~     provides more accurate component alignment following primary total hip replacement compared~     with the current standard treatment, with the aim of improving patient outcomes and reducing~     the risk of complications of total hip replacement.~   "
37736|NCT03072693|"~     Background: Despite the advances in pharmacological management of heart failure (HF), the~     associated mortality and re-hospitalization for HF remain poor. This is at least partly due~     to suboptimal early discharge care, delayed detection of HF complications, and~     underutilization and under-dosing of evidence-based HF medications. Mobile technology has~     revolutionized inter-personal communication allowing instantaneous, multi-directional, and~     massive data transfer. Nonetheless the potential of these enhanced communications have not~     been fully explored in the management of patients with HF.~      Objective: To explore the potential of state-of-the-art mobile technology for home-based~     remote HF management in order to reduce HF mortality and HF re-hospitalization.~      Study Design: This will be a multicenter, randomized controlled clinical trial in patients~     with HF and reduced left ventricular ejection fraction (LVEF) who are discharged from~     hospital following an episode of acutely decompensated HF. The clinical effectiveness of a~     physician-directed patient self-management strategy based on remotely collected physiological~     data obtained from home-based and wearable devices will be compared with two control groups~     who will receive the home-based remote HF management system without activation or routine~     therapy. In the interventional arm, there will be three modes of home-based HF management:~     (1) Early discharge mode to optimize volume status; (2) Drug escalation mode to ensure the~     utilization of evidence-based medications at the maximum tolerated dose; and (3) Maintenance~     mode to ensure medication compliance and early detection of complications such as acutely~     decompensated HF and atrial fibrillation. The trial will enroll up to 876 patients with LVEF~     <40% who are discharged from hospital after an episode of acutely decompensated HF.~     Randomization to the intervention group or control groups will be in a 1:1:1 ratio with~     follow-up for 1 year. The primary outcome will be a composite of cardiovascular death and HF~     hospitalization within 1 year.~      Summary: DAVID-HF will provide essential information about the role of home-based, remote~     heart failure monitoring that will incorporate instantaneous physician-directed patient-self~     management in the long-term management of HF patients.~   "
37737|NCT03072680|"~     The aim of this study is to analyze the efficacy of several variations of an already~     validated Positive Psychology Intervention (PPI) called Best Possible Self in not flourishing~     population. This will be done through a mobile app specially designed for this aim.~      Concretely, the design will permit to compare the classic intervention (BPS Future), a new~     variation (BPS Past), and a combination of both components (BPS Past+Future).~      Participants will be randomly assigned to one of 3 conditions, in which they will practice~     the intervention for two weeks:~        -  BPS-PAST + BPS FUT condition: Participants will practice BPS Past for one week, and then~          they will switch to BPS future for another week.~        -  BPS-FUT condition: Participants will practice BPS Future for two weeks.~        -  CONTROL condition: Participants will practice DAILY ACTIVITIES for two weeks.~   "
37738|NCT03072667|"~     This is a compassionate use protocol of an investigational new drug (IND). The overall~     purpose of the treatment is to offer alternative treatment to children who developed~     parenteral nutrition-associated liver disease (PNALD) and have not responded positively to~     currently available medical therapies. PNALD develops in newborns dependent on parenteral~     nutrition (PN) and are unable to tolerate adequate enteral feedings to support fluid and~     nutritional fluids; although PN is necessary and life sustaining, it can result in severe~     liver disease.~   "
37739|NCT03072654|"~     The investigators aimed at investigating the effects of thyroidectomy on tracheal anatomy and~     airflow in patients with benign nodular goiter, employing a prospective observational study.~      Magnetic resonance images of the neck and respiratory flow-volume curves were performed prior~     to and six months following surgery. Tracheal and thyroid volumes, smallest cross-sectional~     area of the trachea (SCAT), tracheal narrowing, tracheal deviation and tracheal encirclement~     by the thyroid were evaluated. Through flow-volume curves respiratory function, including~     both in- and expiration, was evaluated.~   "
37740|NCT03072641|"~     The purpose of the study is to determine if probiotic bacteria have a beneficial effect on~     the colon cancer-associated microbiota and epigenetic alterations in colon cancer. Dietary~     supplementation consists of two ProBion Clinica tablets, yielding a daily dose of 1.4 x 10 ˄~     10 Bifidobacterium lactis Bl-04 (ATCC SD5219), 7x10 ˄ 9 Lactobacillus acidophilus NCFM (ATCC~     700396), and 0.63 g inulin.~   "
37741|NCT03072628|"~     Randomized controlled trial of electronic cigarettes with nicotine, without nicotine,~     nicotine inhaler, and sham-control on endothelial function, oxidative stress and sympathetic~     nerve activity~   "
37742|NCT03072615|"~     The aim of our prospective multicenter study was to investigate the prognostic value of the~     acute and long-term changes of liver stiffness in patients receiving a transjugular~     intrahepatic portosystemic shunt (TIPS).~   "
37743|NCT03072602|"~     The purpose of the study is to discover any racial dissimilarity in the response of~     Natriuretic peptide (NP) system to acute metabolic influences such as a high carbohydrate~     challenge~   "
37744|NCT03072589|"~     This study will evaluate the maximum safe dose and duration of regadenoson (Lexiscan) that~     can be given to people who are having a lung transplant. Regadenoson will be given as a~     continuous IV infusion. All participants in the study will receive a regadenoson infusion~     beginning in the operating room during the lung transplant procedure. Participants will be~     assigned a certain dose of regadenoson to be given over a 12 or 24 hour period.~   "
37745|NCT03072576|"~     Consenting adults presenting with signs and symptoms compatible with pulmonary tuberculosis~     will be interviewed for demographic and medical information, and then will be asked to~     provide 3-4 expectorated sputum specimens. In the study laboratory, sputa will be tested~     using conventional and investigational diagnostic tests for tuberculosis and rifampin~     resistance.~   "
37843|NCT03071289|"~     Cervical cancer of early stage is treated mainly by radical resection and (or) radiotherapy.~     And pelvic lymphocyst is one of the most common adverse events of radical resection. The aim~     of this study is to compare observation with radiation on pelvic lymphocyst of cervical~     cancer patients after radical resection, for incidence of adverse events and local recurrence~     rate.~   "
37746|NCT03072563|"~     The cerebro-placental ratio (CPR) is a tool for assessment of fetal wellbeing in the~     management of the growth restricted fetus. CPR is the ratio of the fetal middle cerebral~     artery pulsatility index (PI) to the umbilical artery PI. In Gestational Diabetes (GDM), the~     common finding is of accelerated and asymmetric fetal growth. Pregnancies complicated by GDM~     have an increased risk of certain complications such as preeclampsia, intrauterine demise, CS~     due to fetal distress. These complications have a well known association with fetal growth~     restriction leading to the hypothesis that there exists a subset of diabetic fetuses that~     exhibit a growth restriction phenotype despite not being small for gestational age (<10%).The~     objective of this study is to examine whether the CPR can identify GDM fetuses that are not~     growth restricted but are at increased risk of certain adverse neonatal outcomes. Women with~     singleton pregnancies and a diagnosis of GDM at 24 weeks of gestation and beyond will be~     included. Exclusion criteria are Pre-gestational diabetes, hypertensive disease of pregnancy~     at time of recruitment, fetus with a known major anomaly, fetal EFW < 10%(IUGR). Women who~     consent to the study will have a blinded Doppler assessment of CPR. Clinicians will be~     blinded to these Doppler measurements (unless they are indicated clinically for another~     reason (suspected fetal anemia or IUGR development- and the results will be unblinded and~     reported to the clinicians). Obstetric and neonatal outcomes will be collected prospctively~     via the local BORN database and the patient chart. Local BORN is needed for the registered~     outcomes. Newborns will be divided post-hoc into two groups: A) last CPR <10% B) Last CPR >~     10%. The primary outcome will be a composite outcome consisting of one or more of the~     following: Caesarean section due to suspected fetal distress, 5 minute Apgar <7, Cord~     arterial PH < 7, HIE, NICU admission >24 hours.~   "
37747|NCT03072550|"~     Early feasibility study to determine if a three-treatment protocol with the RenewalNail™~     plasma treatment system over a week will result in mycological cure and/or clear nail growth~     on the treated hallux toe.~   "
37748|NCT03072537|"~     CrescNet is a network of Primary care physicians and pediatricians (n=221) and~     endocrinological treatment centers (n=31), established in Leipzig in 1998, whose aim is to~     improve the early detection of growth disorders. Secondary to this clinical aim,~     epidemiological analyses on secular trends of growth data of children are performed.~   "
37749|NCT03072524|"~     The aim of this study is to develop and validate a simple prehospital stroke scale, which~     would predict the presence of large vessel occlusion (LVO) in patients with acute stroke.~     This study prospectively evaluates the predictive value of a new simple pre-hospital scale~     (FAST PLUS test) for the presence of large vessel occlusion in anterior intracranial~     circulation. The FAST PLUS test consists of two parts: the first is the well-known FAST test,~     which is employed in all possible cases of stroke occurrence. This test consists of the~     following items: Speech (scored 0-1), Facial palsy (0-1), any failure of Arm motor function~     (0-1), and Time (0-1). The second part of FAST PLUS test evaluates only the presence of~     severe arm or leg motor deficit (scored 0-1) and unilateral occurrence of its motor function~     deficit (scored 0-1).~      The FAST PLUS test will be used prospectively at the place of stroke onset by trained medical~     emergency technicians. The first objective of study is to evaluate the sensitivity,~     specificity, and the positive and negative predictive value of the test which relate to the~     presence of occlusion of intracranial artery (intracranial carotid artery, T occlusion and~     occlusion of Middle Cerebral artery segment M1 and M2). CT angiography can only diagnose the~     LVO.~      The second objective of this study is to assess inter-rater variability among stroke~     specialists and emergency technicians, concerning the presence of severe motor arm or leg~     deficit.~      The third objective : After implementation of the FAST TEST to clinical practice, we aim to~     achieve the acceleration of transport time in FAST PLUS positive patients via direct~     transport to Comprehensive Stroke Center to mechanical thrombectomy.~   "
37750|NCT03072511|"~     Cigarette smoking is the leading cause of preventable mortality in the United States, yet~     less than 10% of smokers making a serious quit attempt remain abstinent from cigarettes 1~     year later, and outcomes from gold-standard behavioral interventions leave much room for~     improvement. As such, in the context of a Stage-I randomized controlled trial (RCT), this~     study will examine (1) treatment characteristics and delivery, treatment integrity, dropout,~     and acceptability, (2) smoking outcomes such as lapse, relapse, and abstinence measures, and~     (3) changes decision-making that result from a novel intervention informed by behavioral~     analysis and social cognition.~   "
37751|NCT03072498|"~     The purpose of this study is to collect information and bone marrow, blood, saliva, cheek~     cells and skin to be used in the laboratory to assist the sponsor in identifying a new way of~     treating MDS.~   "
37752|NCT03072485|"~     This is a phase 1 study in healthy adult volunteers to examine the effects of 3 FDA approved~     medications on skin aging when applied in topical form. This is an open label, placebo~     controlled study.~   "
37753|NCT03072472|"~     This study aims to assess the effect, if any, on the adenoma detection rate of BowelScope~     bowel cancer screening flexible sigmoidoscopies by using the Endocuff Vision device.~   "
37754|NCT03072459|"~     A retrospective, multi-center, cohort study with prospective follow-up and comparison to~     historical control~   "
37755|NCT03072446|"~     The purpose of this post-market study is to evaluate UFE agents for the treatment of~     symptomatic uterine fibroids, using Gel-Bead compared to four other commonly used embolic~     agents.~   "
37756|NCT03072433|"~     This cluster-randomized controlled trial will evaluate the effectiveness of a four-day~     hospital-based intervention program for primary caregivers of children with severe~     malnutrition.~   "
37757|NCT03072420|"~     The objectives was to obtain MRI images of the index finger of the subjects without loading~     and with loadings (normal and shear forces from 1 to 4N).~   "
37758|NCT03072407|"~     This was a phase 1, randomized, double-blind, placebo-controlled, sequential parallel group,~     MAD study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of four~     once-weekly subcutaneous doses of PB-119 to subjects with T2DM.~   "
37759|NCT03072394|"~     A randomized clinical trial to test the efficacy of EMLA cream (lidocaine 2.5% and prilocaine~     2.5% in a ratio of 1:1 by weight) in comparison to the established local anesthesia (LA)~     protocol of lidocaine subcutaneous injection, in providing adequate peri-operative local~     anesthesia during transradial coronary angiography.~   "
37778|NCT03072134|"~     Malignant gliomas have a very poor prognosis with median survival measured in months rather~     than years. It is a disease in great need of novel therapeutic approaches. Based on the~     encouraging results of our preclinical studies which demonstrate improved efficacy without~     added toxicity, the paradigm of delivering a novel oncolytic adenovirus via a neural stem~     cell line in combination with radiation and chemotherapy is well-suited for evaluation in~     newly diganosed malignant gliomas. The standard-of-care allows application of virotherapy as~     neoadjuvant therapy and assessment of the cooperative effects with radiation/chemotherapy~     without altering the standard treatment.~   "
37760|NCT03072381|"~     The proposed project will be the first to assess pain- and function-dependent, elbow-specific~     quality of life and in-vivo mechanical properties of common extensor tendons post-treatment~     with PRP in a Level 1, RCT with subject and assessor blinding. The valuable data gained will~     significantly add to the knowledge base of treatment effects of PRP for a chronic~     tendinopathy. Positive findings of PRP compared to control (corticosteroid injection) would~     suggest future larger scale studies to help establish an optimal protocol for the nonsurgical~     management of CLE. Correlating US and shear wave acoustoelastography imaging assessments with~     validated clinical outcomes will provide a powerful tool for future outcomes analyses using a~     non-invasive imaging modality to monitor tissue healing both morphologically as well as~     biomechanically, and may even be used to evaluate injury risk.~   "
37761|NCT03072368|"~     The goal of our study is to examine eye color at birth and the longitudinal change in eye~     color of preterm and full-term newborns.~   "
37762|NCT03072355|"~     Introduction: The exercise performed with elastic tools has been appearing in the current~     scenario as a clinical tool because it presents advantages such as easy handling, low cost~     and safety. However, its use as an assessment tool, specifically for localized muscular~     resistance, is reduced and not standardized. In addition, there are no records of the~     physiological / neurofunctional effects of tests that use such a tool, since it allows a~     differentiated degree of prescription. Objective: To determine the reliability and~     reproducibility of a shoulder abduction resistance test in two tools, elastic tube and~     isokinetic dynamometer. In addition to analyzing the metabolic profile of both comparative~     order and targeting subsequent training prescription. Method: The study will consist of a~     sample of 30 participants and will be carried out in 2 stages, 15 participants will perform~     step 1 and the other 15 will perform step 2. The difference between the steps is the order of~     the tools used to perform the test . Each stage will consist of 5 sessions (Orientation,~     Familiarization 1 and 2, Test and Retest). During the test and retest sessions the~     physiological response of the test will be analyzed. In order to observe the response, will~     be analyzed the lactic anaerobic parameter (lactate concentration), allelic anaerobic~     (post-exercise oxygen uptake analysis - EPOC), aerobic parameter (VO2 values) and~     electromyographic measurements. Will be used the statistical package SPSS Statistics 22.0,~     Pearson's correlation and their respective confidence intervals will indicate the~     relationship between the numerical variables and multivariate models will be constructed by~     means of linear regression. The significance level of 5% will be adopted.~   "
37763|NCT03072342|"~     The investigators wish to assess whether intensive periodontal therapy will reduce the burden~     of chronic periodontal disease and will cause regression or prevent progression of~     atherosclerosis assessed by a surrogate end−point (carotid intima−media thickness) at 24~     months compared to control periodontal therapy.~   "
37764|NCT03072329|"~     The purpose of this study is to check whether the success rate of blind pudendal nerve block~     in penile surgery can be optimized by the search for a motor response during~     neurostimulation.~   "
37765|NCT03072316|"~     The investigators intend to undertake a study to investigate the effect of radiotherapy on~     deep inferior epigastric perforator flap reconstructions (DIEP). Adjuvant post-mastectomy~     radiotherapy (PMRT) is offered to women at high risk of chest wall recurrence. The perceived~     detrimental effect of radiotherapy on an immediate breast reconstruction and the one-off~     nature of autologous reconstruction leads some surgeons to recommend delayed reconstruction~     after mastectomy or to use a temporising implant with a view to planned exchange to~     autologous reconstruction after radiotherapy. However, there remains significant uncertainty~     in the literature about the impact of radiotherapy on autologous reconstructions. This study~     is a mixed methology study using patient reported outcome measures (PROMS), applanation~     tonometry (measure of breast compressibility), semi-structured interviews and 3 dimensional~     photography analysis to compare the aesthetic and impact on quality of life on the following~     groups of patients:~      Patient groups:~        1. Unilateral skin sparing mastectomy (SSM) with immediate DIEP flap reconstruction and~          PMRT (cases)~        2. Unilateral SSM with immediate DIEP flap reconstruction and no PMRT (controls)~        3. Unilateral simple mastectomy, PMRT, and subsequent delayed DIEP flap reconstruction~          (controls)~        4. Unilateral SSM with temporizing implant, PMRT and subsequent conversion to DIEP~          (controls)~   "
37766|NCT03072303|"~     The purpose of this study is to learn about pregnancy outcomes in osteogenesis imperfecta~     (OI). Patients enrolled in the Brittle Bone Disorders (BBD) Contact Registry (CR) will be~     invited via email to participate in this study.~   "
37767|NCT03072290|"~     To compare the effectiveness of different dose of ultrasound guided steroid injection in~     patient with carpal tunnel syndrome, by using clinical and electrophysiological parameters in~     evlauation~   "
37768|NCT03072277|"~     DHANI-2 is an extension to DHANI (NCT01580345) which proposes to extend maternal~     supplementation (DHA or Placebo) from <20 weeks of gestational age through 6 months~     postpartum and infant follow-up through 12 months. Leveraging the RCT design, DHANI-2 aims to~     assess the role of maternal DHA supplementation on infant neurodevelopment and body growth.~     It also intends to enhance the mechanistic understanding by the addition of repeated~     biochemical measures from mother-child dyads.~   "
37779|NCT03072121|"~     The purpose of this study is to determine whether Shexiang Baoxin Pill is effective in the~     treatment of coronary artery disease not amenable to revascularization on the basis of~     western medicine therapy.~   "
37780|NCT03072108|"~     This clinical study evaluates if the oral administration of Bonolive can contribute to the~     improvement of functionnality in healthy elderly people with knee discomfort.~   "
37781|NCT03072095|"~     This randomized controlled pilot study at the Health Annex, Family Practice & Counseling~     Network (FPCN), a community clinic in Southwest Philadelphia, aimed at providing data on the~     feasibility of a mailed FIT approach to CRC screening in a community health setting, and how~     patients respond to text messaging and behavioral economic engagement incentives.~   "
37782|NCT03072082|"~     The purpose of this study is to determine whether Danlou Tablet is effective in the treatment~     of coronary artery disease not amenable to revascularization on the basis of western medicine~     therapy.~   "
40767|NCT03033095|"~     The aim of this trial is the caracterisation of a predicting algorithm of the answering~     response for patients with etanercept treatment in spondyloarthritis disease.~      This algorithm will help to target patients patients who have a risk / benefit important for~     etanercept treatment.~   "
37769|NCT03072264|"~     The literature suggests that Mindfulness Based Intervention may be effective in the treatment~     of anxiety symptoms. The objective of this study is to compare the clinical effectiveness of~     a Mindfulness Based Intervention - the Mind in Body Training (MBT) - with a selective~     serotonin reuptake inhibitor (Fluoxetine) and an active control group (Quality of Life)~     through different biological and clinical outcomes, as well as evaluate some possible~     mechanisms of treatment response. Methods: it is a three armed randomized, controlled~     clinical trial. Participants with General Anxiety Disorder will be recruited. A community~     sample of 192 participants will be randomly allocated to the MBT, Fluoxetine or Quality of~     Life Group. Instruments measuring anxiety, worry and meta-worry symptoms, quality of life,~     acceptance and self-compassion, mindfulness, rumination and emotion regulation will be~     applied. The patients will be submitted to Error Related Negativity (ERN) and Heart Rate~     Variability (HRV) measures. The primary outcome is the effectiveness of MBT compared with~     Fluoxetine and Quality of Life Group in symptomatic outcomes. The secondary outcome are the~     effectiveness os these interventions in emotional regulation process and biological measures~     (ERN and HRV), and the evaluation of BMT mechanisms through possible mediation of treatment~     response for emotional processes like mindfulness, acceptance and self-compassion, biological~     changes (ERN and HRV), and metacognition.~   "
37770|NCT03072251|"~     To assess concerns and barriers for measuring milk intake of breast fed infants using the~     remote food photography method and SmartIntake smartphone application. These data will 1)~     provide support for further development of the Infant RFPM and 2) provide important~     preliminary data in a National Institutes of Health grant application being developed and~     assess the prevalence of exclusive breastfeeding and complementary breastfeeding in the study~     population.~   "
37771|NCT03072238|"~     The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of~     ipatasertib plus abiraterone and prednisone/prednisolone compared with placebo plus~     abiraterone and prednisone/prednisolone in participants with metastatic castrate-resistant~     prostate cancer (mCRPC).~   "
37772|NCT03072225|"~     The investigators want treat Vulnerable plaque of carotid artery with a herbal and insects~     Chinese medicine. Designing a RCT trial to prove the effect and safety.~   "
37773|NCT03072212|"~     We will recruit participants from three tertiary care hospitals in Uganda into an~     observational cohort study of people living with HIV/AIDS (PLWHA) and HIV-uninfected persons~     matched for gender and residency, presenting with CT-confirmed stroke. We will collect socio~     demographic, clinical, laboratory, radiologic, cardiac, and clinical neurologic disease~     measures to investigate the effect of HIV-infection on 1) clinical and radiologic~     presentation, 2) risk factor profiles; and 3) stroke outcomes (death or disability).~   "
37774|NCT03072199|"~     RITA-MI aims to develop of a novel therapeutic concept to target the immune response in~     patients with acute myocardial infarction (MI) by depleting B-cells with a single injection~     of Rituximab which is approved for clinical use in cancer, autoimmune disease and~     inflammatory conditions. The goal is to re-purpose the drug, and translate the discovery into~     benefit for patients at high risk of cardiovascular events. Rituximab is expected to limit~     infarction size and improve the healing process, as complementary to other therapeutic~     strategies.~      The applicants intend to perform a clinical study in patients with acute myocardial~     infarction (MI). The objective is to find the optimal dose (lowest dose with highest~     biological efficacy and best safety profile) for peripheral blood B cell depletion during the~     first 6 days after injection, and selective molecular signatures associated with improved~     heart function through analysis of peripheral blood samples.~      The study rationale is to decrease the inflammatory reaction upon tissue necrosis following~     heart muscle ischemia.~   "
37775|NCT03072173|"~     We intend to study, in depth, the quantitative and qualitative properties of nasal~     respiration in sleep-disordered breathing and sleep apnea and its relation to (CPAP)~     treatment with the final goal of improving patient outcome.~      To do this we will temporarily alter patients' nasal airflow during monitored sleep to lower~     CPAP air pressure, making CPAP treatment more acceptable to the patient. Additionally we plan~     to implement highly advanced computerized modelling in collaboration with the OSASMOD~     research consortium at St. Olavs Hospital/NTNU and SINTEF to predict the results of our~     alterations and ultimately, to use these predictions to improve both the planning and the~     outcomes of nasal surgery.~   "
37776|NCT03072160|"~     Background:~      Medullary thyroid cancer (MTC) is a tumor of the thyroid gland. Surgery is the only current~     treatment to cure it. The drug pembrolizumab (MK-3475) is a new type of cancer therapy. It~     works by allowing the immune system to detect and kill tumor cells.~      Objective:~      To test how pembrolizumab affects people with MTC and if it can offer them clinical benefit.~      Eligibility:~      People ages 18 and older with MTC~      Patients who have recurrent or metastatic MTC, for whom surgery is not a curative option~      Patients with some imaging evidence of MTC~      Patients with minimal symptoms related to MTC~      Design:~      Participants will be screened with:~        -  Medical history~        -  Physical exam~        -  Blood, urine, and heart tests~        -  CT scan or MRI: They lie in a machine that takes pictures of the body.~        -  Bone scan~      Participants will be put in a group based on their treatment history:~        -  Group 1 if they have had an immune stimulating cancer vaccine~        -  Group 2 if they have had no vaccine~      Participants will receive the study drug as a 30-minute IV infusion every 3 weeks. Treatment~     will continue for up to 2 years as long as they tolerate it and their disease does not get~     worse.~      Participants will have physical exams and blood tests on the day of each infusion. They will~     have CT and bone scans every 3 months.~      Participants may save biopsies before treatment and after starting treatment.~      Participants will have a final visit 3-4 weeks after stopping treatment. This will include a~     physical exam and blood and heart tests.~      After this study, participants will can join a long-term follow-up study.~   "
37777|NCT03072147|"~     The purpose of this study is to evaluate teriparatide (TP) as a chondroregenerative therapy~     for human knee osteoarthritis (OA). The central hypothesis to be tested is that TP supports~     structural modification of the joint and improves biomarker, functional and patient-reported~     measures of knee OA.~   "
38724|NCT03059823|"~     The primary goal of this Phase 1 study is to characterize the safety and tolerability of~     INCMGA00012 and establish the maximum tolerated dose (MTD) of INCMGA00012 administered on~     either every two week or every four week schedules of administration among patients with~     solid tumors. Pharmacokinetics, pharmacodynamics, and the anti-tumor activity of INCMGA00012~     will also be assessed.~   "
37783|NCT03072069|"~     Anesthesia in the modern age is at least a two-drug process consisting of an opioid and a~     sedative hypnotic (e.g., fentanyl and propofol in combination, among others). Therefore, it~     is important to understand the interaction pharmacodynamics of these agents as they are used~     clinically. A good method for visualizing the pharmacodynamic interaction behavior of drug~     combinations is through response surface models. Unlike traditional isobolograms that~     represent the concentrations of two agents that combine to produce a single degree of drug~     effect, response surface models characterize the complete spectrum of interaction between two~     or more agents for all possible levels of concentration and effect. The investigators try to~     use the response surface model to evaluate the effect of anesthetic combination of autonomic~     system.~   "
37784|NCT03072056|"~     -  To evaluate the pharmacokinetic (PK) profile of MIN-101 and its metabolites in extensive~          (EM) and poor (PM) metabolizers~        -  To evaluate the relationship between plasma levels of MIN-101 and changes in QT/QTcF~          intervals~        -  To evaluate safety and tolerability of MIN-101.~   "
37785|NCT03072043|"~     The main purpose of this study is to determine the safe and recommended dose of APR-246 in~     combination with azacitidine as well as to see if this combination of therapy improves~     overall survival.~   "
37786|NCT03072030|"~     The purpose of this study is to evaluate immunogenicity, epidemiological efficacy and safety~     of medicinal product GamEvac-Combi - Combined Vector-Based Vaccine against Ebola Virus~     Disease, 0.5 ml+0.5 ml/dose~   "
37787|NCT03072017|"~     Insomnia can be a chronic problem that leads to significant daytime fatigue, stress and~     numerous negative health consequences including depression. Advanced Medical Electronics, in~     partnership with researchers are the University of Pennsylvania, propose developing an~     innovative, non-drug, low-risk, intervention that can be implemented on mobile devices for~     the treatment of insomnia.~   "
37788|NCT03072004|"~     We are going to investigate leprosy patients with neuropathies. This problem can lead to~     changes in nerve function and lead to disability. We will investigate a protocol with LLLT to~     improve pain, inflammation, and to prevent disabilities. We will test two groups, which will~     be divided into control and LLLT treated patients. In this groups we will perform~     quantitative measurements of the following parameters before and after the protocol~     application: electroneuromyography and muscle strength measurements, evaluation of activity~     limitation and risk awareness, evaluation of tactile sensitivity and evaluation of~     temperatures of hands and feet. Averages for all parameters will be compared before and after~     treatment (12 application sessions). We believe that LLLT can become an important alternative~     treatment to improve conduction velocity, tactile sensitivity, temperatures of hands and~     feet, muscle strength and pain, which will prevent nerve damage and disabilities~   "
37789|NCT03071991|"~     Postoperative pain and use of narcotic analgesics after laparoscopic bariatric surgeries are~     problems that need to be solved in terms of patient comfort. We believe that preincisional~     bupivacain injection to the trocar sites will help us for these problems. A study is designed~     focused on reduced postoperative pain and reduced use of narcotic analgesics by preincisional~     bupivacain injection for laparoscopic bariatric patients.~   "
37790|NCT03071978|"~     This study is designed to assess the clinical outcomes of Left-Ventricular (LV) fusion pacing~     compared to Bi-Ventricular (BV) pacing, also known as Cardiac Resynchronization Therapy~     (CRT), in Chinese Heart Failure (HF) population. Specifically, the study will assess the~     changes of cardiac function of each group through 3-month follow up/ 6-month follow up~     compared with original outcomes before aCRT (adaptive Cardiac Resynchronization Therapy)~     implantation. Secondly, the study will assess whether parameters of aCRT that were tested in~     Western population are relevant to parameters of Chinese HF patients.~   "
37791|NCT03071965|"~     This study is a prospective, phase 2 extension study of participants previously enrolled in~     NTMT-01 and of participants enrolled in NTMT-02. This study is designed to evaluate long term~     safety and efficacy of the NT-501 implant in participants previously enrolled in the NTMT-01~     and NTMT-02 protocols.~   "
37792|NCT03071952|"~     The primary objective of this study is to assess the clinical efficacy of AAIR (Atrial-paced~     Atrial-sensed Inhibitory Rate-Modulated) pacing treatment for heart failure (HF) patients~     with chronotropic incompetence (CI) in terms of exercise tolerance and quality of life.~     Specifically, the study will assess the changes in cardiac function associated with changes~     of physical exercise intensity and heart rate in AAIR pacing mode compared with AAI pacing~     mode.~   "
37793|NCT03071939|"~     Schizophrenia is a disease of young adults that affects 1% of the general population.~     According to numerous studies, it has been estimated that between 50% and 80% of patients~     with schizophrenia do not consider to have a mental disorder and are therefore not aware of~     their disorders. A poor degree of insight is associated with poor compliance, a higher number~     of re-hospitalizations, altered social and relational functioning, and a higher number of~     suicides and violent behaviors. This is why insight, which is an essential dimension of~     psychopathology, must be evaluated, as it depends to a large extent on the therapeutic~     alliance, adherence to treatment, likelihood of relapse and prognosis.~   "
37794|NCT03071926|"~     Metronomic PLD in Patients with Primary Endocrine Resistant ABC~   "
37795|NCT03071913|"~     This pilot research trial studies blood brain barrier differences in patients with brain~     tumors undergoing surgery. Studying samples of tissue and blood from patients with brain~     tumors in the laboratory may help doctors to understand how well drugs get into different~     parts of a brain tumor. This may help them to determine which types of drugs may be best for~     treating brain tumors.~   "
37796|NCT03071900|"~     Detection rate and isolation yield of CTC is low in squamous cell carcinoma of head and neck~     (SCCHN) with in vitro approaches rely on limited sample volumes. In this study, we applied a~     new method, the CellCollector, which could capture CTC in vivo from peripheral blood.~   "
37797|NCT03071887|"~     The goal of this study is to refine and pilot the Relaxation Response Resiliency (3RP)~     intervention for women age 50 and over who are living with HIV, a group especially burdened~     by stressors related both to aging and living with chronic disease. The investigators will~     adapt the 3RP resiliency intervention to the needs of this population and conduct preliminary~     testing of the group intervention via an open pilot study.~   "
37798|NCT03071874|"~     This research study is studying a chemotherapy as a possible treatment for Meningiomas~     (recurrent).~      The study intervention involved in this study is:~      --AZD2014 (vistusertib)~   "
37805|NCT03071783|"~     The objective of the clinical investigation is to test whether intra-operative traction force~     feed back during vacuum extraction leads to a significant decrease in incidence of brain~     damage in neonates.~      By randomization, half of the vacuum extraction patients will be assigned to delivery using a~     new intelligent handle for vacuum extractions, and half will be assigned to conventional~     method without traction force measurement.~   "
37806|NCT03071770|"~     The purpose of this Phase I, single-dose, open-label trial is to evaluate the~     pharmacokinetics and safety of ivosidenib (AG-120) in healthy, adult male Japanese and~     Caucasian subjects. The study plans to evaluate 3 cohorts of a single oral dose of ivosidenib~     (AG-120) in Japanese and Caucasian subjects. Pharmacokinetic sampling will take place~     serially through-out the duration of subject participation.~   "
37807|NCT03071757|"~     The primary purpose of this Phase 1, open-label study is to evaluate the safety,~     pharmacokinetics, and preliminary efficacy of ABBV-368 as a monotherapy and in combination~     with nivolumab in participants with locally advanced or metastatic solid tumors. The study~     will consist of 2 parts: ABBV-368 dose escalation and ABBV-368 tumor-specific dose expansion~     (non-small cell lung cancer [NSCLC] cohort and head and neck cancer cohort) .~   "
37808|NCT03071744|"~     Advanced cancer patients often require palliative (pain relieving) radiotherapy to treat~     cancer-related symptoms. The delivery of radiation requires patients to lie still on a hard~     flat surface, which can result in significant acute (intense) pain and/or breakthrough cancer~     pain (sudden sharp or stabbing pain), especially when painful bone metastases are present.~     The current care for most cancer patients receiving radiation is to take an oral (by mouth)~     opioid medication before the radiation treatment. The pain relieving effects of these~     medications can take about one hour and can last for 3 to 6 hours, which does not follow the~     time course of when breakthrough cancer pain occurs.~      Lazanda is a pain medication delivered via an intranasal route and is already approved by the~     U.S. Food and Drug Administration (FDA) for the management of breakthrough cancer pain for~     patients who are already receiving opioids and who can tolerate opioids for the treatment of~     cancer pain. Lazanda is fast-acting and convenient for patients to take. The purpose of this~     study is to assess the change in pain intensity during palliative radiotherapy following~     study treatment with Lazanda. This study will also explore the impact of the study treatment~     on the efficiency in delivering the radiation therapy~   "
37809|NCT03071731|"~     This project is aimed to assess the responsiveness of the Glittre ADL-test and the 1-Minute~     Sit-to-Stand test (1-Minute STST) to acute bronchodilation in patients with COPD. We also aim~     to investigate the physiological and perceptual response to bronchodilation of the Glittre~     ADL-test and the 1-minute STST. The specific objectives are 1)To measure the changes in time~     for completion of the Glittre ADL-test and the number of standing up during the 1-minute STST~     induced by a single dose of nebulized ipratropium bromide/salbutamol sulfate against those~     induced by a placebo in patients with moderate to severe COPD and 2)To compare in patients~     with moderate to severe COPD the CR (minute ventilation (VE), oxygen uptake (VO2), carbon~     dioxide production (VCO2) and heart rate) and symptomatic (dyspnea and leg fatigue~     perception) responses during the Glittre ADL-test and the 1-Minute STST following a single~     dose of ipratropium bromide/salbutamol sulfate or placebo. We suppose among others that the~     Glittre test completion time will be lesser, that the number of repetitions in the 1-Minute~     STST will be higher and symptoms intensity will be lesser among patients with COPD receiving~     bronchodilators.~   "
37810|NCT03071718|"~     Mediterranean diet (Med-D) has been recognized as an intangible cultural heritage by UNESCO~     and was shown to be beneficial for the treatment of obesity, type-2 diabetes and~     cardiovascular diseases. Individuals with the highest adherence to Med-D (classified~     according to Sofi et al., 2010) were characterized by increased levels of specific~     fibre-degrading bacteria, increased faecal levels of short chain fatty acids, and lower~     urinary concentrations of the atherogenic compound TMAO. However, the interplays between~     Med-D and microbial populations in the intestine remain unclear. Moreover, a number of~     clinical conditions like obesity, T2D, and atherosclerosis are associated with dysbiotic~     microbial ecosystems in the gut, i.e., shifts in the structure and function of the~     microbiota, but the characteristic features of dysbiotic gut communities and the impact of~     diet are not very well defined. The present study will evaluate the impact of Med-D on~     cardiometabolic health in human subjects via modification of intestinal microbial communities~     and its impact on health outcomes, mainly related to inflammatory, oxidative and hormonal~     status, in overweight subjects.~   "
37811|NCT03071705|"~     Treatment for patients with mutation in the epidermal growth factor receptor (EGFR) with~     specific domain tyrosine kinase inhibitors (TKIs) has given place to objective clinical~     response, increase in progression-free survival (PFS) compared to cytotoxic chemotherapy.~     However, despite clinical success with different TKIs, most patients eventually develop~     acquired resistance to these agents after an average period of time of 10 months.~      Recently metformin, an oral hypoglycemic agent, has been associated with reduction in the~     global risk of incidence and mortality of different types of cancer, by exercising anti-tumor~     properties. Its role as a chemo-preventive and adjuvant drug in overcoming acquired~     resistance to chemotherapy, target therapy and immunotherapy in NSCLC is still under~     discussion.~      However, preclinical data support the role as an adjuvant drug in the treatment of NSCLC in~     combination with chemotherapy or EGFR-TKIs. This evidence led to examine the effects of~     metformin in combination with EGFR-TKIs in a NSCLC cellular line panel, obtaining a different~     sensibility to the unique use with EGFR-TKIs. The combination of metformin and TKIs reduced~     the colony forming capacity and proliferation, and induced a huge pro-apoptotic effect in~     NSCLC cellular lines and resistance in EGFR-TKIs. This suggests that metformin may reduce the~     resistance to TKIs. A retrospective study in patients from our institution from 2008 to 2014,~     showed significant clinical benefit in patients who used metformin, improving the global~     survival. Based on these considerations, we propose a phase II randomized study to assess the~     effect and safety of metformin in combination with TKIs as second line therapy in patients~     with NSCLC in advanced stages with EGFR mutation.~      The main objective of this study is to assess the progression-free survival period in~     patients with advanced non-small cell lung cancer in treatment with TKIs and metformin versus~     TKI alone.~   "
37812|NCT03071692|"~     The primary objective of the study is to determine whether pemafibrate administered twice~     daily will delay the time to first occurrence of any component of the clinical composite~     endpoint of:~        -  nonfatal Myocardial Infarction (MI)~        -  nonfatal ischemic stroke~        -  hospitalization for unstable angina requiring unplanned coronary revascularization; or~        -  Cardio Vascular (CV) death.~   "
37813|NCT03071679|"~     This study has a randomized, evaluator-blinded, vehicle- controlled study to assess the~     pharmacodynamics of omiganan and omiganan with imiquimod in healthy volunteers.~   "
38725|NCT03059797|"~     To compare the effects and safety of Anlotinib with placebo in patients with small cell lung~     cancer(SCLC).~   "
37814|NCT03071666|"~     Scientific basis: Globally, vitamin B12 deficiency is one of the most common micronutrient~     deficiencies. The only relevant source of vitamin B12 is animal-source foods and poor gut~     function may decrease absorption. Vitamin B12 is crucial for normal cell division and~     differentiation, and necessary for the development and myelination of the central nervous~     system. Deficiency is also associated with impaired fetal and infant growth. In the proposed~     study we will measure the effect of daily oral vitamin B12 supplementation to pregnant women~     on neurodevelopment and growth of their children. We also aim to measure the impact of B12~     supplementation on several other outcomes.~      Study design: Individually randomized double-blind placebo controlled trial in pregnant South~     Asian women at risk of poor vitamin B12 status. Participants will be randomized in a 1:1~     ratio.~      Study participants and site: 600 pregnant women from early pregnancy. Women will be enrolled~     as early as possible, but no later than in week 15 of pregnancy.~      Intervention: Daily administration of 50 µg of vitamin B12 from early pregnancy until 6~     months after birth.~      Comparator: Placebo, identical to the vitamin B12 supplements.~      Outcomes: Primary: (i) neurodevelopment in children measured at 6 and 12 months of age (ii)~     growth in children measured by weight and length at 12 months. Secondary: (i)~     neurodevelopment and cognitive functioning in children at 24 months (ii) gestational age at~     birth, (iii) fetal and infant growth measured by weight and length at birth, after 1 month~     and then at 3, 6, 9, and 24 months, (iv) hemoglobin concentration in children and mothers.~      Relevance for programs and public health: The results from this study can suggest new dietary~     guidelines for South Asian women that again can lead to improved pregnancy outcomes and~     neurodevelopment and cognitive functioning in South Asian children.~   "
37815|NCT03071653|"~     A randomized controlled trial to test the potential safety and efficacy of LCSD in patients~     with heart failure due to non-ischemic and ischemic cardiomyopathy at the University of Cape~     Town. Left Cardiac Sympathetic Denervation (LCSD) is a surgical intervention that modulates~     the autonomic innervation of the cardiac system. This is important because: a] sympathetic~     and parasympathetic tone has a profound effect on the threshold for ventricular~     tachyarrhythmias-the main cause of sudden cardiac death in this population; and b] autonomic~     dysfunction (which is characterized by an imbalance between sympathetic and parasympathetic~     activation), plays an important detrimental role in the pathophysiology and progression of~     heart failure.~   "
37816|NCT03071640|"~     This study is a first part of a larger project aiming at improving the following outcomes in~     older cancer patients receiving external beam radiation therapy (EBRT): quality of life,~     functioning and need for professional help (dependency). To achieve this, the investigators~     will develop and test a geriatric assessment (GA) with management (GAM) intervention~     targeting patients at risk of negative outcomes as defined. The problems and needs that older~     patients experience before, during and after EBRT are poorly described. Furthermore, although~     GA is the recommended approach to assess older cancer patients' vulnerability, very few~     studies have investigated its benefit and feasibility in a radiotherapy setting and there is~     no universal recipe for how an efficient GAM intervention should be applied in this setting.~     Before defining and testing an intervention, the investigators will therefore conduct an~     observational study addressing older patients >= 65 years referred for either palliative or~     curative EBRT. The main objectives are to identify patients at risk for negative outcomes,~     and to test the feasibility of GA in the community service and at a radiotherapy department.~   "
37817|NCT03071627|"~     The main objective of this study is to compare the interpretation of health news items~     reporting results of pre-clinical studies with or without spin (i.e., distortion of research~     results). The news items which reported those studies evaluating the treatment effect either~     in cell culture studies or animal studies, have high number of spin in the headline and text~     and received high online public attention will be selected. Spin will be deleted and will~     rewrite the news items without spin. This sample of news items reporting results of~     pre-clinical studies with and without spin will be interpreted by French-speaking population.~   "
37818|NCT03071614|"~     The main objective of this study is to compare the interpretation of health news items~     reporting results of pre-clinical studies with or without spin (i.e., distortion of research~     results). The news items which reported those studies evaluating the treatment effect either~     in cell culture studies or animal studies, have high number of spin in the headline and text~     and received high online public attention will be selected. Spin will be deleted and will~     rewrite the news items without spin. This sample of news items reporting results of~     pre-clinical studies with and without spin will be interpreted by English-speaking~     population.~   "
37819|NCT03071601|"~     The purpose of this study is to determine if topical analgesia using a lidocaine and~     prilocaine cream improves pain scores compared to the usual local anesthesia using~     subcutaneous 1% lidocaine and adrenalin injected near the laceration.~   "
37820|NCT03071588|"~     The aim of the study is to assess clinically, radiographically and microbiologically a new~     protocol for indirect pulp capping procedures compared to the conventional protocol in~     painful teeth. It was postulated that there is no difference between both protocols in terms~     clinical, radiographical and microbial outcome measure after one year of follow up in painful~     teeth.~   "
37821|NCT03071575|"~     This is an open-label, randomized, 2-arm clinical trial in healthy infants in Bangladesh. The~     primary purpose of the study is to assess the immunogenicity of measles-rubella (MR) vaccine~     when delivered at 6 months. In addition, the study will establish the equality of MR vaccine~     seroconversion administered at 9 months following administration of an earlier MR vaccine~     dose at 6 months of age compared to MR vaccine dose administered at 9 months without previous~     MR vaccination. This study will also provide additional data on safety and tolerance of MR~     vaccine given at 6 months, and impact of maternal antibodies on immunogenicity of MR vaccine~     at 6 months.~        -  Primary objectives:~             1. To assess immunogenicity of MR vaccine at 6 months of age~             2. To assess immunogenicity of MR vaccine at 9 months of age among children without~               prior measles and rubella vaccination, compared with MR vaccine immunogenicity~               among those who had a prior MR vaccination at 6 months of age~        -  Secondary objectives~             1. To assess the frequency of adverse reactions following administration of MR vaccine~               at 6 months~             2. To compare the immunogenicity of the MR vaccine first dose administered at 6 months~               vs at 9 months.~             3. To assess the proportion of mothers with undetectable, detectable and protective~               levels of measles and rubella antibodies~             4. To determine the extent of variation in measles antibodies in women of child~               bearing age in a population with a long standing measles vaccination program~             5. To determine the extent of variation in rubella antibodies in women of child~               bearing age in a population where rubella vaccine have been recently introduced~             6. To determine if variation in antibody levels in infants at 6 months is~               predominately explained by variation in starting antibody levels in the mother in~               this population~             7. To estimate the half-life of decay of measles and rubella antibodies in infants~   "
37844|NCT03071276|"~     This study will be done in two parts: Phase I (NCT02212561) has been completed and published.~     The goal of the Phase I portion of this study was to find the highest tolerable dose of~     selinexor (KPT-330) that can be given to patients with leukemia or myelodysplastic syndrome~     (MDS), when it is combined with fludarabine and cytarabine.~      The Phase II portion of the protocol is reflected in this registration.~      The goal of the Phase II portion of this protocol is to give the highest dose of selinexor~     (KPT-330) in combination with fludarabine/cytarabine that was found in Phase I to be safe for~     children with acute myeloid leukemia (AML). The investigators will examine the effect of this~     combination treatment.~   "
37845|NCT03071263|"~     The purpose of this study is to determine if patiromer treatment in chronic kidney disease~     (CKD) subjects receiving spironolactone for the treatment of resistant hypertension will~     result in more persistent use of spironolactone through prevention of hyperkalemia and lead~     to improved blood pressure control compared with treatment with spironolactone alone~     (placebo).~   "
37822|NCT03071562|"~     Approximately 50% of people living with HIV (and as many as 80% over the age of 50) have~     difficulties with cognitive functions such as memory and thinking that can have a profound~     negative impact on activities of daily living and quality of life. Problems with memory and~     thinking are also associated with forgetting to take anti-retroviral drugs and experiencing~     challenges to balance, walking and mental health (anxiety and depression). There is~     increasing evidence that, in the general population, exercise has positive effects on~     cognition, physical functioning and mental health. Despite the recognition of multiple~     therapeutic benefits of exercise, little attention has been paid to its possible effects on~     cognition in people living with HIV. The purpose of the proposed pilot study is to compare~     the effects of a 12-week, randomly assigned, community-based yoga-mindfulness intervention on~     cognition, balance, walking, mental health and quality of life in 30 people >35 years of age~     living with HIV in the Halifax area. Yoga is of particular interest because it encompasses~     not only the physical but also spiritual, emotional, and mental dimensions of life. As such,~     it has tremendous potential to help stave off some of the devastating consequences of HIV~     infection.~   "
37823|NCT03071549|"~     Acne patients were included in this randomized controlled trial. Each patient received four~     treatment sessions two weeks apart. 20% azelaic acid combined with 20% salicylic acid were~     applied to the one side of the face while 25% trichloroacetic acid was applied to the other~     side. Evaluation was done by counting number of non-inflammatory and inflammatory lesions~     before, after two and after four treatment sessions. The dermoscope was used in evaluating~     the degree of improvement of erythema.~   "
37824|NCT03071536|"~     Furosemide is an old drug that has been used frequently in the postoperative period of kidney~     transplantation, aiming to achieve adequate urine output. There is no previous study that~     directly evaluate the urine response to standardized dose of furosemide in the postoperative~     period. The objective is to measure the urine output after standardized dose of furosemide is~     delivered, as a biomarker to predict the graft function in perioperative period.~   "
37825|NCT03071523|"~     Different augmentation techniques has been proposed to resolve problem of hard and/or soft~     tissue ridge defects to enable dental implant placement. Guided bone regeneration GBR~     procedure is considered as an acceptable reliable surgical procedure for localized ridge~     augmentation. Exposure of the membrane used for the GBR is considered a major disadvantage of~     this procedure. In order to avoid such complication, various flap advancement techniques have~     been proposed such as Periosteal releasing incision,Double-Flap Incision,Coronally advanced~     lingual flap. The study compare between the flap advancement provided by Periosteal releasing~     incision,versus,Coronally advanced lingual flap in the treatment of class 1 ridge defect.~   "
37826|NCT03071510|"~     The objective of the study is to compare Atlas Genetics io® system results with those~     obtained from comparator devices.~   "
37827|NCT03071497|"~     -  In approx. 40% of the incidences anemia is caused by iron deficiency (= ID). In turn,~          preoperative iron-deficiency anemia (= IDA) is associated with an increase in morbidity~          and mortality as well as with the need for a blood transfusion.~        -  A successful preoperative treatment of IDA via iron supplementation requires a timely~          screening of iron deficiency, typically done by analyzing specific blood parameters.~          This however of course requires drawing a blood sample which further reduces the~          patients' blood volume and is in many cases stated as an inconvenient procedure.~        -  Measured in blood zinc protoporphyrin-IX (= ZnPP) is an established parameter to detect~          ID.~        -  This study aims to evaluate a prototype device detecting ZnPP non-invasively in the~          intact oral mucosa of surgical patients.~        -  Results from the non-invasive measurement will be compared to reference measurements of~          ZnPP from residual blood samples (HPLC analysis) as well as to other parameters~          including Hb level and iron profile (MCH [= mean corpuscular hemoglobin], MCV [= mean~          corpuscular volume], ferritin, transferrin, transferrin saturation, soluble transferrin~          receptor, CRP).~   "
37828|NCT03071484|"~     Background: Cognitive deficits are a core symptom of schizophrenia even at the early stages~     of psychosis. To date, there has been reliable evidence that cognitive deficits are~     associated with outcomes in schizophrenia and early treatment could help to reduce the~     prominent disabling cognitive symptomatology which most schizophrenia patients still~     experience persistently. Outcomes in studies of repetitive transcranial magnetic stimulation~     in schizophrenia patients suggest the possibility that application of transcranial~     direct-current stimulation (tDCS) with inhibitory stimulation over the left temporo-parietal~     cortex and excitatory stimulation over the left dorsolateral prefrontal cortex could affect~     positive and negative symptoms, respectively. Positive effects of tDCS have also been~     reported on cognitive symptoms. The present study protocol hypothesis is that the development~     and utilization of potentially effective neuroenhancement tools such as a non-invasive brain~     stimulation technique like tDCS for the treatment and rehabilitation of cognitive impairment~     in early stages of Schizophrenia may contribute to the elucidation of the nature of the~     complex and dynamic processes in the brain during the early stages of the disease, and may~     lead to a better outcome.~      Objectives: The aim of the present study protocol is to evaluate the efficacy of tDCS in the~     treatment of cognitive symptomatology in the early stages of psychosis.~      Methods: Sixty patients in the early stages of psychosis will be randomly allocated to~     receive 20 minutes of active 2-mA tDCS or sham stimulation once a day on 10 consecutive~     weekdays. The anode will be placed over the left dorsolateral prefrontal cortex and the~     cathode over the left temporo-parietal cortex. Neuropsychological and psychiatric assessments~     will be performed at the time of consent (baseline), at 1 and 3 months following the end of~     the intervention (maintenance effect).~   "
37829|NCT03071471|"~     Adolescent idiopathic scoliosis (AIS) is a common disorder of unknown etiology in which the~     vertebrae and discs gradually develop a curvature that is first detected in patients between~     11 and 20 years of age. The deformity is 3-dimensional, with a coronal curve measured from~     radiographs by the Cobb angle .~      The Cobb angle measurement of scoliosis represents the sum of the angular wedging of each~     vertebra and disc between the superior and inferior end vertebrae . Although a small curve is~     well tolerated and does not require treatment, a large curve can progress to the point that~     it is cosmetically unacceptable, interferes with chest wall mechanics, and produces cardiac~     and pulmonary compromises. The natural history of AIS apparently includes 2 stages: the~     initiation of the curve and its subsequent progression. The factors responsible for the~     initiation of the curve are unknown, but the subsequent progression of the curve is clearly~     associated with the adolescent growth spurt . The primary risk factors for progression~     include age at onset and the magnitude of the curve; young patients with large curves are at~     the highest risk .~      Although numerous treatment methods have been recommended for patients with AIS, the only~     accepted treatment includes bracing for skeletally immature patients with curves between 25~     and 40 degrees and operative correction with spinal fusion for patients with curves greater~     than 45 degrees. For many teenagers, the cosmetic and social concerns associated with bracing~     has caused compliance problems with wearing the brace and many patients only wear the brace~     at home . While operative intervention completely corrects the scoliosis or rib hump, it~     eliminates segmental spinal motion, and concentrates stresses at the ends of the fusion~     potentially leading to disc degeneration and back pain.~      Despite satisfactory short-term results of operative instrumentation and fusion, a less~     invasive technique preserving more motion with a smaller scar represents a major improvement.~     Realizing this goal is contingent on treating curves early, before they progress to an~     irreversible deformity, and when there is still enough residual growth and remodeling~     potential.~      ApiFix Ltd has developed a novel implant for less invasive treatment of AIS. The MID-C system~     is designed to correct the deformity step by step along a period of time, giving the skeletal~     and soft tissues time to accommodate any incremental correction.~      The MID-C System inherent benefits are:~        -  Only two screws are used~        -  Incision size is much smaller~        -  Simpler operation with shorter operative time~        -  Less complications (attributed to the three points above).~        -  Minimal spinal mobility loss.~      All the device components are made of materials well accepted in the orthopedic field and are~     fully biocompatible (see Investigator Brochure).~      The unique concept of the system and the materials used may provide favorable results as~     follows: Smaller scare, quicker healing period and better spine mobility over the years.~      This study is designed to demonstrate that the MID-C System is safe and effective.~   "
37830|NCT03071458|"~     The MUTHEC project aims to describe the mutational and transcriptomic landscape of HCC~     treated by curative treatments (resection, radio frequency ablation, transplantation) as well~     as advanced HCC together with the analysis of circulating tumor DNA.~   "
37831|NCT03071445|"~     Adolescent idiopathic scoliosis (AIS) is a common disorder of unknown etiology in which the~     vertebrae and discs gradually develop a curvature that is first detected in patients between~     11 and 20 years of age. The deformity is 3-dimensional, with a coronal curve measured from~     radiographs by the Cobb angle .~      The Cobb angle measurement of scoliosis represents the sum of the angular wedging of each~     vertebra and disc between the superior and inferior end vertebrae . Although a small curve is~     well tolerated and does not require treatment, a large curve can progress to the point that~     it is cosmetically unacceptable, interferes with chest wall mechanics, and produces cardiac~     and pulmonary compromises. The natural history of AIS apparently includes 2 stages: the~     initiation of the curve and its subsequent progression. The factors responsible for the~     initiation of the curve are unknown, but the subsequent progression of the curve is clearly~     associated with the adolescent growth spurt . The primary risk factors for progression~     include age at onset and the magnitude of the curve; young patients with large curves are at~     the highest risk .~      Although numerous treatment methods have been recommended for patients with AIS, the only~     accepted treatment includes bracing for skeletally immature patients with curves between 25~     and 40 degrees and operative correction with spinal fusion for patients with curves greater~     than 45 degrees. For many teenagers, the cosmetic and social concerns associated with bracing~     has caused compliance problems with wearing the brace and many patients only wear the brace~     at home . While operative intervention completely corrects the scoliosis or rib hump, it~     eliminates segmental spinal motion, and concentrates stresses at the ends of the fusion~     potentially leading to disc degeneration and back pain.~      Despite satisfactory short-term results of operative instrumentation and fusion, a less~     invasive technique preserving more motion with a smaller scar represents a major improvement.~     Realizing this goal is contingent on treating curves early, before they progress to an~     irreversible deformity, and when there is still enough residual growth and remodeling~     potential.~      ApiFix Ltd has developed a novel implant for less invasive treatment of AIS. The MID-C system~     is designed to correct the deformity step by step along a period of time, giving the skeletal~     and soft tissues time to accommodate any incremental correction.~      The MID-C System inherent benefits are:~        -  Only two screws are used~        -  Incision size is much smaller~        -  Simpler operation with shorter operative time~        -  Less complications (attributed to the three points above).~        -  Minimal spinal mobility loss.~      All the device components are made of materials well accepted in the orthopedic field and are~     fully biocompatible (see Investigator Brochure).~      The unique concept of the system and the materials used may provide favorable results as~     follows: Smaller scare, quicker healing period and better spine mobility over the years.~      This study is designed to demonstrate that the MID-C System is safe and effective.~   "
37846|NCT03071250|"~     The care for patients receiving total hip and knee arthroplasty at the University of Arkansas~     for Medical Sciences has followed a structured care pathway since July 2015. This system of~     perioperative care has focused on preoperative assessment of medical co-morbidities and risks~     to postoperative functional recovery, anesthetic care focused on postoperative nausea and~     vomiting prevention and optimizing immediate postoperative functional ability, and aggressive~     postoperative physical therapy.~      This is an observational study to look at the outcomes of this program at University of~     Arkansas for Medical Sciences. Areas of focus will be hospital length of stay, postoperative~     narcotic consumption, Visual Analog Scale scores, incidence of postoperative nausea and~     vomiting, and 30-day readmission rates, and health literacy rates.~   "
37847|NCT03071237|"~     Infrapyloric artery(IPA) is of great importance for gastric cancer patients. According to~     previous study, the origin of IPA varies greatly among different studies. This trial aims to~     tell the distribution of IPA origin in Chinese patients.~   "
37832|NCT03071432|"~     Rationale: Complications of chronic hyperglycaemia associated with Diabetes Mellitus type 2~     (DM2) include macro- and microvascular angiopathy. Cerebral Autoregulation (CA), the~     capability of the brain to maintain constant cerebral blood flow (CBF) despite changes in~     blood pressure, is impaired early in DM2 implicating that CBF becomes dependent on blood~     pressure. In addition, 20-60% of all patients with DM2 suffers from cardiovascular autonomic~     neuropathy (CAN) resulting in more unstable blood pressure regulation. In patients without~     DM2 or CAN, induction of anaesthesia results in slightly decreased blood pressure, but~     cerebral perfusion is maintained through CA. In contrast, patients with DM2 and CAN may~     display greater reductions in blood pressure and cerebral perfusion may become jeopardized~     due to impaired CA. This could be an explanation for the increased incidence of stroke in~     patients with DM2.~      Objective:~        1. To study whether peri-operative haemodynamics fluctuate more in patients with DM2 and~          CAN.~        2. To study whether CAN further worsens cerebral perfusion in addition to impaired CA.~      Study design: Prospective, observational cohort trial. Study population: A total of 45~     patients, 30 with DM2 and 15 healthy controls scheduled for elective, non-cardiothoracic~     surgery under general anesthesia and age 18 years and above will be included in the study.~     After inclusion, DM2-patients will be categorized in two groups (both 15 patients): patients~     with and patients without CAN. Given the prevalence of 20-60% CAN, we plan to screen at most~     100 patients and include 15 patients in each study group.~      Intervention (if applicable):~        1. PRE-operative: chart review, short physical examination, autonomic function tests to~          determine the presence of CAN. These tests are simple physiological tests that can be~          performed on a regular ward and involve a Vasalva manoeuvre, 3 minute paced breathing~          with a frequency of 6·min-1 and tests for orthostatic hypotension. Also, we test the~          sensitivity of the cerebral vasculature to CO2 by measuring during one-minute~          hyperventilation and one minute CO2-rebreathing. Continuous blood pressure monitoring~          will be obtained using ccNexfin, a non-invasive monitor that comprises a single~          inflatable finger cuff. Cerebral perfusion will be assessed non-invasively using~          transcranial Doppler attached with a headband to the temporal skin area and~          (non-invasive) measurement of cerebral oxygenation using near-infrared spectroscopy~          (NIRS).~        2. INTRA-operative: we repeat the 3 minute paced breathing test and the CO2-reactivity~          test.~      Main study parameters/endpoints: Between group difference in haemodynamic parameters and~     cerebral perfusion parameters.~   "
37833|NCT03071419|"~     This pilot study evaluates the feasibility and impact of a father-focused childhood obesity~     prevention program on paternal food-related parenting practices, mealtime behaviors and~     father/child nutrition and physical activity behaviors. Half of participants (low-income~     father and child dyads) will receive an intervention immediately while the other half of~     participants will serve as a wait-list control group and receive the intervention at a later~     date.~   "
37834|NCT03071406|"~     The purpose of this study is to test the effectiveness, safety, and tolerability of the drugs~     nivolumab plus ipilimumab with or without the addition of stereotactic body radiation therapy~     (SBRT). Nivolumab is an antibody (a type of human protein) that is being tested to see if it~     will stimulate the body's immune system to work against tumor cells. This study will test an~     investigational use of nivolumab.~   "
37835|NCT03071393|"~     This study will examine if acute intermittent hypoxia (brief episodes of breathing lower~     oxygen), which has been shown to enhance plasticity and motor output, can enhance functional~     outcomes and muscle activation in individuals with spinal cord injury. Our aim is to assess~     breathing, sitting, standing and walking functional ability before and after acute~     intermittent hypoxia, compared to a sham treatment. This information may be useful in~     advancing rehabilitation for people with spinal cord injuries.~   "
37836|NCT03071380|"~     An open label randomized, single dose, two-way crossover bioequivalence study to determine~     the bioequivalence of Rivaroxaban from Repatoxaban 10 mg Tablets (Horus for Pharmaceutical~     Industries, Egypt) and Xarelto® 10 mg Tablets (Janssen Pharm., Licensed from: Bayer~     Healthcare, Germany)~   "
37837|NCT03071367|"~     Multiple studies have shown clinical simulation benefits over classical learning method.~     Research on simulation of airway management has focused on endotracheal intubation training,~     while research on ventilation via facemask is scant. The investigators compared both learning~     methods regarding the acquirement of basic skills for airway management by medical students.~     Students in the clinical simulation group received a 3-hour training on airway management on~     the first day of their 28-day anesthesia rotation, while classical learning did not. On the~     last day of rotation, participants were evaluated based on a validated instrument of scores.~     Primary outcome was airway management scores. Secondary outcomes were rate of success of~     intubation and incidence of complications.~   "
37838|NCT03071354|"~     The investigators propose to conduct a randomized, control trial of~     β-hydroxy-β-methylbutyrate (HMB) supplementation in elderly patients (≥65 years of age) with~     acute respiratory failure, who are identified at high risk for malnutrition by ICU-specific~     nutritional risk scores. Patients will receive either 3g of HMB daily, or control, daily~     until day 28 following randomization (even if discharged).The investigators will measure~     functional outcomes using standard, validated measures prior and after discharge.~   "
37839|NCT03071341|"~     AGT-181 is a fusion protein containing alpha-L-iduronidase that is intended to deliver the~     enzyme peripherally and to the brain, when administered intravenously.~      This is a long term safety and tolerability study of AGT-181 in patients with MPS I who~     completed the previous 26-week study, AGT-181-101. Information on the biological activity of~     the investigational drug will also be collected.~   "
37840|NCT03071328|"~     The purpose of this study is to plan for future clinical trials in patients with Metastatic~     Castration-resistant Prostate Cancer (mCRPC). Diluted iodinated contrast will be injected~     intra-tumorally under CT fluoroscopy guidance into bone, lymph node, and liver metastases in~     subjects with mCRPC, and pre and post-injection CT images will be obtained to determine the~     injection parameters needed for optimal distribution throughout metastases of a given size. A~     biopsy of the metastatic site will also be obtained to validate the expression of CD155 in~     prostate cancer.~   "
37841|NCT03071315|"~     The study compared the effectiveness and cost-effectiveness of two dominant heroin dependence~     treatment approaches: center-based compulsory rehabilitation (CCT) and community-based~     voluntary methadone treatment (MMT) in Hai Phong City, Vietnam. The design was a combined~     retrospective and prospective, non-randomized cohort over three years (with data at five~     time-points). The study was conducted between 2012 and 2015, involving 208 CCT participants~     and 384 MMT participants with heroin dependence.~   "
37842|NCT03071302|"~     Evaluation of tomographic (Pentacam) parameters and genetic parameters of Visual System~     Homeobox 1 (VSX1), Superoxide Dismutase (SOD1), Tissue Inhibitors of Metalloproteinases~     (TIMP3) genes of keratoconus patients diagnosed by clinical exam and topographic pattern.~     Basically we are screening patients that don't have keratoconus that those have keratoconus.~     The pentacam index of corneal curvature, thinnest point, corneal high order aberrations,~     posterior and anterior elevation, corneal densitometry, corneal volume were investigated. To~     analyze the genes, we took corneal epithelium samples of patients submitted to cross linking~     compared to (PRK) Photo Refractive Keratectomy ones. Also will be evaluated the genes of~     peripheral blood.~   "
37851|NCT03071185|"~     The use of free fibular flaps and anterolateral thigh (ALT) flaps for repairing the~     oromandibular defects is well established, whereas few attentions were focused on~     postoperative analgesia for the donor area. The purpose of this trial is to determine if~     using lower limb nerve blocks in patients undergoing free flap-based oromandibular~     reconstruction can significantly decrease use of pain medications and to evaluate the safety~     of lower limb nerve blocks.~      Patients with oromandibular defects who were scheduled for elective reconstructive surgery~     using free fibular or ALT flaps, were divided into two groups in a randomized, single-blind~     fashion. In Group PCA, only intravenous patient controlled analgesia (PCA) was used~     postoperatively. In Group PCA+B, both intravenous PCA and lower limb blocks were used.~     Post-operative narcotic usage, post-operative pain score, post-operative anti-emetic usage,~     vital signs, onset and duration of sensory and motor block, the presence of adverse effects~     such as nausea and vomiting were recorded.~   "
37852|NCT03071172|"~     The aim of this study was to evaluate the efficacy and safety of domestic recombinant human~     follicle stimulating hormone (rhFSH) stimulating ovarian to promote follicular development~     before assisted reproductive technology, which was non-inferiority than that of the imported~     rhFSH.~   "
37853|NCT03071159|"~     Medium-term (6-12 months) evaluation of the use, the identified problems, the usability and~     the effect on the metabolic control of the FreeStyle Flash Libre glucose monitoring system in~     90 children by questionnaires and routine measurement of HbA1c values.~   "
37854|NCT03071146|"~     The medical device being examined in this study is the Bard® LifeStent® 5F Vascular Stent~     System. It is intended for use in patients who suffer from peripheral artery disease (PAD).~     PAD is generally associated with blocked arteries of the legs. The superficial femoral artery~     (SFA) and popliteal artery are common locations for this problem to develop. The patient may~     experience pain or discomfort in the leg that occurs when walking or have other complications~     associated with wound healing. The purpose of this study is to collect information to assess~     the deliverability, clinical utility, safety and effectiveness of the Bard® LifeStent® 5F~     Vascular Stent System.~   "
37855|NCT03071133|"~     An observational, postmarketing commitment following the marketing authorization for DCV Trio~     therapy in Japan~   "
37856|NCT03071120|"~     The goal is to pilot a parent-mediated intervention for feeding challenges in children with~     autism building on our recent research and current successful models already being used. A~     parent-mediated intervention would primarily occur in the home environment, working with the~     parent to establish goals and implement the intervention based on their child's specific~     needs.~   "
37857|NCT03071107|"~     The proposed investigation for this study aims to; 1) understand the prevalence and outcomes~     associated with frailty among haemodialysis patients; 2) ascertain the best frailty~     assessment tool for haemodialysis patients, and; 3) design a clinical study to explore the~     feasibility of facilitating, recruiting and executing a multi-disciplinary clinical and~     psychological intervention to improve frailty status among haemodialysis patients.~      Work package 1: Firstly, there is a need to understand the prevalence and spectrum of frailty~     in a UK haemodialysis cohort and what impact frailty has for haemodialysis patients. To~     investigate this, the investigators will approach every patient on haemodialysis within the~     local catchment of haemodialysis units and, after informed consent, clinically phenotype~     their frailty status (pre- and post-haemodialysis for calculation of variability). The~     frailty phenotyping will encompass a number of frailty assessments (including the Edmonton~     Frail Scale, Clinical Frailty Scale from Rookwood score and Fried Frailty scale) to identify~     the ideal frailty assessment tool. All patients in this observational cohort study will be~     prospectively monitored for clinical/biochemical outcomes using an informatics-based approach~     for up to 60 months.~      Work package 2: Building upon the work conducted in work package 1, work package 2 will aim~     to recruit 50 patients clinically phenotyped with pre-frailty from work package 1 into a~     feasibility study exploring a multi-disciplinary intervention to improve frailty status.~     Eligible patients, after informed consent, will be randomised into active or passive~     intervention. The active intervention will involve a dietitian and physiotherapist who have~     been trained and accredited with cognitive behavior intervention, utilising established~     behavioral intervention frameworks, to deliver a multi-disciplinary clinical intervention~     targeting multiple components of frailty.~      The FITNESS project will therefore answer some important unanswered questions regarding~     frailty among the haemodialysis population and help in the design of a large~     multi-disciplinary intervention study if deemed feasible.~   "
37858|NCT03071094|"~     This is a study to Evaluate the Safety and Efficacy of the Combination of the Oncolytic~     Immunotherapy Pexa-Vec With the PD-1 Receptor Blocking Antibody Nivolumab in the First-line~     Treatment of Advanced Hepatocellular Carcinoma (HCC).~   "
37859|NCT03071081|"~     This study evaluates the safety and tolerability of TOP1288 oral single ascending and~     multiple doses in healthy subjects.~   "
37860|NCT03071068|"~     This study is conducted to evaluate the safety of THR-317 when administered intravitreally~     and to assess the compound's efficacy in improving best-corrected visual acuity (BCVA) and~     reducing central subfield thickness (CST) in subjects with centre-involved diabetic macular~     oedema (DME).~   "
37861|NCT03071055|"~     This is a 24 week open label study to assess the efficacy of bi-weekly ranibizumab for~     patients with retinal fluid due to exudative macular degeneration refractory to monthly~     therapy.~   "
37862|NCT03071042|"~     This study evaluated the tolerance, safety and efficacy of Apatinib plus Docetaxel as the~     second-line treatment in locally advanced or metastatic gastric cancer (including~     Gastroesophageal junction (GEJ) Adenocarcinoma).~   "
37863|NCT03071029|"~     A six-month RCT conducted within 36 health centres throughout urban and rural Nepal. The~     purpose of the RCT is to test the effectiveness of a peer comparison intervention at~     increasing uptake of long-acting reversible contraceptives (LARCs) as a percentage of PAFP~     uptake among clients who receive a safe abortion at a Marie Stopes International Nepal. The~     total sample size will be ~12,000 safe abortion clients. The primary outcome of interest is~     LARCs among safe abortion clients at Marie Stopes Centres in Nepal. The secondary outcome is~     to evaluate the impact of behaviorally designed intervention on the service providers'~     engagement in discussing measures to increase PAFP LARC uptake among women.~   "
37864|NCT03071016|"~     This study is a non-interventional, multicentre, prospective, observational study to be~     conducted at 50 sites in India. The study targets to enrol 2000 patients with 40 patients per~     site. The study will be initiated after obtaining written approval of Independent Ethics~     Committee (IEC) /Institutional Review Board (IRB) and written informed consent of the~     patient.~   "
37920|NCT03070288|"~     The aim of this study was to evaluate the color values of the nasal mucosa, which is easily~     assessable by a direct, non-invasive, objective photographic measurement, for the purpose of~     presenting a diagnostic objective parameter of allergic rhinitis (AR).~      All patients and controls were examined by the same 4 mm 0⁰endoscope and light source, and~     all endoscopic photographs of the septum and both inferior turbinates were taken. Adobe~     Photoshop Elements 7.0 program was used to measure the numerical values of the red-green-blue~     (RGB) color components in endoscopic photographs of the nasal mucosa on the septum and~     inferior turbinates.~   "
37865|NCT03071003|"~     Sensorion are the study sponsor and the objective of this study is to investigate the safety~     and pharmacokinetic (PK) profile of SENS 401 in humans after a single and repeat dose~     administration and to confirm that, there is no interconversion of the (R) enantiomer to the~     (S) enantiomer.~      The study only involves the one drug, referred to as SENS-401.The key objective is to assess~     the safety of SENS 401 after multiple doses in healthy subjects.~      The population who are eligible to take part in the study are healthy male and female,~     non-smoking volunteers, aged between 18 and 50 years, as determined by screening tests at~     Simbec.~      Participation in the trial will last for about 3 weeks (from first screening to final end of~     study visit).~   "
37866|NCT03070990|"~     The objective of this study is to assess the safety, tolerability and pharmacokinetics of~     enfortumab vedotin (ASG-22CE) when administered intravenously to Japanese subjects with~     locally advanced or metastatic urothelial carcinoma. This study will also assess the~     immunogenicity as defined by the incidence of anti-drug antibody (ADA) and anti-tumor~     activity of enfortumab vedotin (ASG-22CE) when administered intravenously to Japanese~     subjects with locally advanced or metastatic urothelial carcinoma.~   "
37867|NCT03070977|"~     Research question and basic idea:~      Interprofessional collaboration is a skill that many health professionals need to develop.~     Interprofessional training offers a way to improve collaboration and patient care. The~     increasing number of psychiatric patients with complex needs, requires mental healthcare~     providers to enhance their skills. It necessitates that healthcare professionals collaborate~     effectively; nevertheless, many have not been trained in an interprofessional environment.~     Health professionals lack sufficient knowledge of other professional roles and competences to~     engage in teamwork. Interprofessional study units have been designed to create an optimal~     learning environment for healthcare students. These study units provide a new environment for~     learning, where students can learn from each other and develop competence in~     interprofessional collaboration. This collaboration gives students from several health~     professions an opportunity to achieve a greater understanding of the overall picture of the~     patient´s life. The limited data available suggest interprofessional collaboration~     interventions can improve health-care processes and outcomes; however, better designed~     studies are needed.~      Objective: Therefore, we will investigate whether placement at a psychiatric study unit~     compared with placement at a standard psychiatric ward improves students´ interprofessional~     skills.~   "
37868|NCT03070964|"~     Prospective, multicenter, phase II clinical trial to determine the efficacy of plitidepsin in~     patients with relapsed/refractory (R/R) angioimmunoblastic Tcell lymphoma (AITL).This is an~     international, multicenter study (with approximately 17 investigative sites).~   "
37869|NCT03070951|"~     The primary objective of this study is to demonstrate the superior efficacy versus placebo of~     OBE2109 alone and in combination with add-back therapy for the reduction of heavy menstrual~     bleeding associated with uterine fibroids in premenopausal women.~   "
37870|NCT03070938|"~     The PuraPly Antimicrobial Wound Matrix (PuraPly AM) case series is a prospective,~     observational study for patients who have received PuraPly AM which consists of a collagen~     sheet coated with polyhexamethylenbiguanide hydrochloride (PHMB) and is intended for the~     management of wounds; no experimental intervention is involved.~   "
37871|NCT03070925|"~     The PuraPly AM case series is a prospective, observational study for patients who have~     received PuraPly AM which consists of a collagen sheet coated with polyhexamethylene~     biguanide hydrochloride (PHMB) and is intended for the management of wounds; no experimental~     intervention is involved.~   "
37872|NCT03070912|"~     ECMO has improved the outcome of heart or respiratory failure and carcinogenic shock and are~     increasingly used. However bleeding complications occurring in up to 50% of patients are~     poorly understood and worsen the overall results. The aim is to investigate the occurence of~     bleeding and its frequency according to the type of ECMO either veno-arterial or veno-venous.~     The investigators also want to assess the relation of bleeding with von Willebrand Factor~     defects.~   "
37873|NCT03070899|"~     The primary objective of this study is to demonstrate the superior efficacy versus placebo of~     OBE2109 alone and in combination with add-back therapy for the reduction of heavy menstrual~     bleeding associated with uterine fibroids in premenopausal women.~   "
37874|NCT03070886|"~     This randomized phase II/III trial studies docetaxel, antiandrogen therapy, and radiation~     therapy to see how well it works compared with antiandrogen therapy and radiation therapy~     alone in treating patients with prostate cancer that has been removed by surgery. Androgen~     can cause the growth of prostate cells. Antihormone therapy may lessen the amount of androgen~     made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink~     tumors. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Giving antiandrogen therapy and radiation therapy with or~     without docetaxel after surgery may kill any remaining tumor cells.~   "
37875|NCT03070873|"~     The investigators designed a prospective study in this article to evaluate the efficacy, the~     life quality and the complications of two different meshes of type I (one is Perigee/Apogee,~     the other is named Gynecare prolift) versus traditional surgery, and also studied the~     influence of some surgical procedures on the prognosis.~   "
37876|NCT03070860|"~     The investigators hypothesize is that in PXE patients, low grade chronic inflammation could~     preceed the molecular and the clinical calcification process.~   "
37877|NCT03070847|"~     The purpose of this study is to determine whether very low dose of preoperative tranexamic~     acid (5mg/kg) is as effective as low dose (10mg/kg) for intraoperational bleeding reduction~     in patients undergoing elective rhinoplasty surgery.~   "
37936|NCT03070080|"~     Fluid administration during and after surgery is an essential part of postoperative care to~     maintain the patients' fluid and biochemical balance. Abdominal surgical procedures are~     associated with dehydration from preoperative fasting, bowel preparation, and intra- and~     postoperative fluid and electrolyte loss. So, perioperative fluid management has been a topic~     of much debate over years and has intensified especially over the past several years.~   "
40358|NCT03038477|"~     This is a two-arm, open-label, phase II study of in adult patients who have successfully~     undergone R0/R1 resection of PDAs following neoadjuvant chemotherapy and completion of~     adjuvant chemotherapy. Within 1-3 months of treatment completion, patients will be enrolled~     and randomized at a 1:1 ratio to receive durvalumab versus observation.~   "
37878|NCT03070834|"~     The risk of venous thromboembolism (VTE) is very high in trauma patients, secondary to tissue~     injury, venous status from immobilization, and thrombophilia. As such, early initiation of~     VTE prophylaxis is essential in this population. The competing risks of life threatening~     hemorrhage and VTE need to be considered very carefully. Potential approaches to VTE~     prophylaxis include pharmacologic means, and mechanical devices. For patients unable to~     receive pharmacologic VTE prophylaxis, retrievable inferior vena cava filters (rIVCFs) may be~     placed until low molecular weight heparin (LMWH) can be initiated, as per guidelines such as~     Eastern Association for the Surgery of Trauma~      The investigators propose a feasibility study to determine whether or not our center can~     insert rIVCFs in at-risk trauma patients expeditiously enough to cause a meaningful reduction~     in the time they are left unprotected to PE.~   "
37879|NCT03070821|"~     The project aims to investigate in patients of Alzheimer's disease in a prodromal state~     (early state of the disease) compared to healthy subjects whether neurofeedback training with~     functional MRI (fMRI) can improve cognitive ability. It is of interest if voluntary~     modulation of brain activation with real-time (rt) fMRI as a novel method affects cognitive~     ability, as well as functional and structural measures of the brain.~      Over the course of the study subjects will learn a real-world footpath. During neurofeedback~     training subjects are then asked to recall this footpath while simultaneously trying to~     modulate their own brain activation based on feedback. Feedback is given about the~     parahippocampal gyrus - a region of the brain associated with episodic and visuo-spatial~     memory, which is known to be affected early by Alzheimer's disease pathology.~      Before and after the training cognitive ability is assessed using neuropsychological tests~     mainly measuring numerous domains of memory.~      The investigators hypothesise that the training leads to an improvement of the trained~     cognitive domain, but also induces changes in brain structure and function.~   "
37880|NCT03070808|"~     The rate of obesity and bariatric surgery is rising steadily. Though Bariatric Surgery~     Influences on aspects such as endocrin analysis, finance, etc are well tested, quantitative~     and quality voice impacts have not been evaluated. The aim of the study is to recruit 50~     patients who underwent bariatric surgery and compare voice quality in each of these patients~     before and after surgery.~   "
37881|NCT03070795|"~     study compares the outcomes of feeding mothers early (4 hours ) after cesarean section~     compared to delayed feeding (on post operation day 1) in terms of gastrointestinal function~     and maternal satisfaction with the feeding schedule.~   "
37882|NCT03070782|"~     This is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to~     evaluate the safety, including tolerability, of ISIS 681257 and to assess the efficacy of~     different doses and dosing regimens of ISIS 681257 for reduction of plasma Lp(a) levels in~     patients with hyperlipoproteinemia(a) and established cardiovascular disease (CVD).~   "
37883|NCT03070769|"~     The aim of our study was to assess the levels of inflammatory biomarkers in a large sample of~     OSA patients and to investigate any correlation between these markers with clinical and~     polysomnographic (PSG) parameters.~      Subjects undergone a PSG for OSA diagnosis were recruited. Patients with known comorbidities~     were excluded from the study. Included patients were grouped according to apnea-hypopnea~     index (AHI) as mild, moderate and severe. Patients with AHI < 5 served as control group.~     Demographic, PSG data, serum levels of hs-C-reactive protein (hs-CRP), fibrinogen,~     erythrocyte sedimentation rate (ESR) and Uric Acid (UA) were measured and compared between~     groups.~   "
37884|NCT03070756|"~     This study implements an extended (post marked) examination of the efficacy of a proactive~     auto-CPAP algorithm, which is based on the forced oscillation technique (FOT) in a sample of~     patients with predominantly obstructive sleep apnea. The auto-CPAP algorithm examined in this~     study is implemented in the medical devices prisma20A and prismaLAB (Löwenstein Medical~     Technology).~   "
37885|NCT03070743|"~     Posterior compression distraction reduction technique （PCDR） in the treatment of Basilar~     invagination associated with atlantoaxial dislocation~   "
37886|NCT03070730|"~     The purpose of this study is to test the hypothesis that patients with non-neuropathic POTS~     will have different responsiveness than patients with neuropathic POTS to direct alpha-1~     adrenoreceptor agonist therapy (droxidopa) and to non-selective beta-adrenoreceptor~     antagonist therapy (atenolol).~      The specific goal of this protocol is to investigate the effect of atenolol and droxidopa on~     cardiovascular autonomic functions such as cardiovagal control, sympathetic nerve activity,~     and sympathetic vascular transduction, systemic hemodynamic response to orthostatic stress~     and on the quality of life in neuropathic and non-neuropathic patients with postural~     tachycardia syndrome (POTS).~      Standardized tests are used to assess cardiovagal control function, sympathetic nerve~     activity, sympathetic vascular transduction, systemic hemodynamic response to head-up tilt~     test and standardized questionnaires to assess the quality of life in patients with POTS.~      The cardiovagal, sympathetic and hemodynamic measurements are performed after and during drug~     administration. To control the effect of medications placebo is used on separate testing~     visits. The order of drugs and placebo is randomized.~   "
37887|NCT03070717|"~     This research project intends to observe patients with high myopia who show pathological~     retinal changes, in order to evaluate more data on the risk factors for developing mCNV~     within this research project population in Germany.~   "
37888|NCT03070704|"~     This study is conducted in Asia. The aim of this study is to evaluate long term safety and~     efficacy in patients with type 2 diabetes mellitus in routine clinical practice in India.~   "
37889|NCT03070691|"~     This 22 week study will assess the efficacy, safety, and tolerability of LDE225 versus~     vehicle when applied topically to basal cell carcinoma (BCC) in patients with NBCCS. Patients~     will treat multiple BCCs for up to 12 weeks. Treatment success is defined as complete~     clinical clearance and complete histological clearance in BCCs.~   "
37890|NCT03070678|"~     Primary Objective:~      To assess the effect of multiple dose mefenamic acid on the pharmacokinetics (PK) of~     sotagliflozin and its metabolite in healthy male and female subjects.~      Secondary Objectives:~        -  To assess total 24 hour urinary glucose excretion (UGE) after 400 mg sotagliflozin alone~          and in combination with mefenamic acid in healthy male and female subjects.~        -  To assess the safety and tolerability of sotagliflozin alone and in combination with~          mefenamic acid in healthy male and female subjects.~   "
37891|NCT03070665|"~     Endoscopic submucosal dissection(ESD) is a prominent minimally invasive operation technique~     for treating early gastrointestinal tumor. But promoting ESD is uneasy because of its~     complications such as postoperative bleeding, perforation and so on. So if we decrease the~     rate of postoperative bleeding, ESD might be better popularized. Some study indicated that~     hypertension was the independent risk factor of postoperative bleeding. Endoscopic center of~     Fudan University Zhongshan Hospital is a rich experienced medical unit in doing ESD operation~     in China. Referring to our experience, if we can use some special methods to find the~     potential bleeding spot which is not obvious during ESD operation and we coagulate it~     precisely, then we may control the risk of postoperative bleeding.~      Based on the above hypothesis, our team designed this study to examine whether increasing~     blood pressure during gastric ESD could help to control the risk of postoperative bleeding.~   "
37892|NCT03070652|"~     Key research question This project addresses the following key research question: What are~     the short and long term effects on child and family outcomes of a universal intervention~     delivered by a Health Visitor addressing the newborn´s behavior in a shared observation with~     the parents (NBO)? The aim is to enhance the parent's sensitivity to their infants' unique~     capacities and thereby create an early parental understanding for the individual infant's~     strengths as well as its needs.~      Hypothesis concerning main outcomes~      Universal Health Visiting with facilitation of the early relationship building introduced by~     the NBO to an intervention group of new families will- when compared to a control group of~     new families who receive health visitor support as usual:~        -  Improve sensitive responsive parenting to the infant's behavior, needs for feeding and~          comfort, and rise understanding of parental influence on the infants' self-regulatory~          capacities~        -  Increase parental confidence and reduce experiences of stress and symptoms of depression~          among new mothers and fathers~        -  Improve the infant's self-regulatory capacities regarding sleep, crying, feeding and~          engaging in social interactions, being more cooperative~        -  Enhance the sensitive early parent/infant relationship~        -  Improve exclusive breastfeeding duration and delay introduction to solid food~      Method The project is formed as a community based randomized trial. The complexity in~     community based intervention research is the existence of two target groups, in this case: 1)~     the primary study population of new parents that receive the supportive intervention and 2)~     the secondary study population of Health Visitors that deliver the supportive intervention.~     The complication of catching the effects in a universal approach will be addressed through a~     variety of outcomes that capture both the aspect and the development of the infant, the~     mother and the father and the interactions.~      Recruitment and randomization Four medium-sized municipalities will join in the trial. To~     avoid side-effects the districts of the Health Visitors in the participating municipalities~     will be regarded as clusters. Because of differences in size and social status of the~     inhabitants in the districts alias the clusters, the clusters will be stratified before they~     are randomized to intervention or comparison group. The randomization procedure will be~     computer based and conducted by an independent person not involved in the study.~      Study population The primary study population is formed by new families, mothers and fathers~     and their infant/s. Substantiated in that we are operating with a community based universal~     intervention with no side effects and we seek to measure the effect in a natural population~     we will have no exclusion criteria except parents or infants affiliated to special treatment~     elsewhere.~      In the study population of new parents there will be subgroups: First time parents will~     represent around 40 %, around 6 % will have given premature birth, 2% twin birth, 10-14% of~     the mothers and 7-8% of the fathers will suffer from birth depression in the postnatal~     period, and 7-20% will have a cultural background other than Danish depending on geographical~     area.~      A random sample of 100 mothers who have received the intervention will be drawn for video~     recording in the middle of the project period after specified characteristic criteria with~     regard to first-time-, depressed- and given premature birth. Afterwards a matched group of~     100 mothers will be selected in the comparison group.~      Data and data-collection Data will be collected from two sources: (1) self-reported data from~     the new parents collected via questionnaire; (2) observational data from video recordings,~     Infant CARE-Index. Questionnaire data will be delivered and collected though an internet~     based system. Participating mothers and fathers will receive separate questionnaires at 1-2~     weeks postpartum (baseline data), 3 months postpartum, 9 months follow-up, 18 months~     follow-up. Videos are recorded at 3 months post-partum (corrected age for premature infants)~     with 3 minutes of unstructured time together; (Infant CARE Index). All data will be linked~     via the Danish Personal Register (CPR) identifier. To minimize bias introduced by data~     collection, data will be collected in the same way and with the same timing in the~     intervention and comparison groups.~      Data Analysis Intention to treat analysis will be used to detect the effect of the community~     based intervention where motivation and participation may vary in both the primary and~     secondary study population. Supplemental analysis will be performed to identify an~     intervention effect for subgroups and marginal groups of parents according to parity, preterm~     delivery, and depression symptoms.~   "
37893|NCT03070639|"~     The specific aims of the study are to: 1) evaluate the impact of the safe sleep intervention~     on parents' knowledge, beliefs, intentions, skills and practices related to creating and~     maintaining a safe sleep environment for their infants during the first four months of life;~     2) describe the characteristics of physician anticipatory guidance about safe sleep and~     identify physician, patient and parent characteristics associated with coverage of the topic~     at the well-child visits; and 3) evaluate the dissemination of the B'more for Healthy Babies~     (BHB)'s safe sleep campaign messages and services among our study participants.~   "
37894|NCT03070626|"~     Administration of preoperative oral carbohydrates are suggested to reduce insulin resistance~     due to surgical stress.~      The aim of this study is to investigate whether preoperative oral carbohydrate loading can~     contribute to lower incidence of postoperative discomfort and to reduce complications in~     elective lung cancer patients undergoing video assisted thorascopic surgery (VATS).~   "
37895|NCT03070613|"~     This is a feasibility study investigating the use of a fluorescently conjugated lectin to~     identify colorectal dysplasia and cancer during colonoscopy and surgery.~   "
37896|NCT03070600|"~     In a region with 15-20% HIV prevalence, an estimated 20% of HIV-uninfected women could have~     HIV exposures in pregnancy. In a theoretical scenario of perfect PrEP coverage, all women at~     risk receive PrEP while no women not at HIV risk receive PrEP (Figure 4). With mandatory PrEP~     given to all women (similar to the approaches used for malaria prophylaxis), all women at~     risk would be covered but many women not at risk receive unnecessary PrEP. Our premise is~     that a targeted PrEP model may be closer to perfect coverage than a universal~     offer/self-select model. Implementing targeted PrEP through strategies that include~     facilitation of partner testing with self-tests could add HIV prevention benefit by~     increasing partner HIV diagnosis and treatment similar to the initiation of PrEP among~     pregnant women. By implementing these strategies and measuring uptake, process, and HIV~     incidence, we can inform the best health systems model for PrEP delivery in pregnancy.~   "
37897|NCT03070587|"~     The purpose of this study is to develop and test a mindfulness and loving-kindness based~     intervention, Positive Affect Training (PAT), to enhance positive affect such as compassion,~     love, and gratitude and reduce symptoms of social anxiety disorder (SAD). PAT involves a~     combination of practicing mindfulness meditation and loving kindness meditation in groups.~     Although PAT has been shown to be effective for dysthymic disorder, one area that remains~     unclear is whether the PAT protocol for SAD can address the social anxiety symptoms in~     Japanese adults with SAD. The goal of the research is to test the initial feasibility and~     efficacy in increasing positive affect and decreasing negative affect in individuals~     recruited from the general community who are social anxious. If PAT is also effective for~     Japanese SAD patients, it could be more cost-effective and noninvasive option to address~     social anxiety disorder.~   "
37898|NCT03070574|"~     Multicenter, multinational, randomized, 3-arm, double-blind, phase II clinical study with~     2400mg Mesalamine, 1200mg Mesalamine or placebo for prevention of neoplasia in Lynch Syndrome~     patients for 2 years.~   "
37899|NCT03070561|"~     Open label, cross-over, local pharmacokinetics study of a sublingual film with peanut extract~     in healthy adults and children~   "
37900|NCT03070548|"~     This study will evaluate the mass balance of talazoparib after a single dose of talazoparib.~   "
37901|NCT03070535|"~     This study involves the collection of cognitive and biomarker responses to HIGH and LOW meals~     in healthy older adults with and without the APOE E4 genotype. Subjects will eat the meal~     after an overnight fast, followed by cognitive testing, spinal fluid and blood collection.~     The HIGH meal will be a meal high in saturated fat and high glycemic index foods vs. LOW meal~     which will be low in saturated fat and low glycemic index foods.~   "
37902|NCT03070522|"~     This will be a 3 year randomized, double blind, placebo controlled trial of 7 days of oral~     prednisone in cystic fibrosis (CF) patients receiving intravenous (IV) antibiotic treatment~     for a pulmonary exacerbation at the Hospital for Sick Children, St Michael's Hospital, St~     Paul's Hospital, British Columbia Children's Hospital, Hotel Dieu Hospital and Ste Justine~     Hospital, Canada. The intervention will be oral prednisone 2 mg/kg/day (max 60 mg) divided~     twice daily for 7 days as an adjunctive therapy for pulmonary exacerbations in CF patients~     who have not recovered their baseline forced expiratory volume in 1 second (FEV1) after 7~     days of IV antibiotic treatment. The primary outcome will be the proportion of subjects who~     achieve >90% of their baseline FEV1 % predicted at day 14 of IV antibiotic treatment for a~     pulmonary exacerbation in each treatment arm.~   "
37903|NCT03070509|"~     This study is being conducted to evaluate how the body absorbs and processes the medication~     lisdexamfetamine (Vyvanse®). Subjects who are 9-15 months post gastric bypass surgery will be~     invited to participate. Non-surgical controls will also be enrolled based on a matching~     criteria to post gastric bypass subjects. Participants will be asked to complete one 12-hour~     study day and complete one 24-hour post dosing blood draw.~   "
37949|NCT03069911|"~     This study evaluates the efficacy of onabotulinumtoxinA (BOTOX®) in the treatment of~     depression associated with Idiopathic Parkinson Disease in adults. As a Randomized Controlled~     Trial, half of the participants will receive onabotulinumtoxinA injections and half will~     receive a placebo saline solution.~   "
40389|NCT03038048|"~     We are comparing the patient experience between the standard 30 g needle to the smaller 33 g~     needle for intravitreal injections of ranabizumab or aflibercept for age related macular~     degeneration, diabetic macular edema, or retina vein occlusions.~   "
37904|NCT03070496|"~     Ischemic heart disease is the leading cause of mortality with 7.2 million of death in~     industrialized countries (WHO data). Myocardial infarction corresponding to acute occlusion~     of a coronary artery is the most brutal form and the more severe ischemic myocardial disease.~     Every year in France, about 60,000 Myocardial infarctions hospitalized, 30,000 are diagnosed~     remotely and 30,000 are revealed by an inaugural sudden death. Although mortality from~     myocardial decreased by 30% over the past decade, the prognosis is pejorative and difficult~     to assess precisely. The management of the patient depends on these factors, and justifies an~     active search on these topics, including the mechanisms of the deleterious ventricular~     remodeling, myocardial inflammation, reperfusion injury which determines in particular the~     evolution to heart failure. Cohorts of patients with myocardial infarction are rare but can~     be very valuable by their clinical, laboratory and imaging well documented. They are the~     source of new hypotheses for research or interventions as well as the quality of care~     assessment tool.~      The main objective of this project is to identify new markers: biological and imaging,~     treatment response and prognosis after acute myocardial infarction.~      Secondary objectives of the HIBISCUS-STEMI cohort to establish a clinical database, completed~     by biological samples and by imaging data that can be used in the following areas:~        -  Descriptive epidemiology of myocardial infarction and myocardial reperfusion~        -  Pharmacoepidemiology and treatments observatory: safety, efficacy, indication of~          treatment in real life, costs~        -  Assessment of the long-term effect of the treatment on the occurrence of heart failure~          and sudden death~        -  Quality of life and personal consequences, family, professional and social myocardial~          infarction~        -  Research of new diagnostic and prognostic biomarkers~        -  Research projects (e.g. risk of developing kidney failure or stroke in patients with~          myocardial infarction compared to the general population).~   "
37905|NCT03070483|"~     Adequate levels of vitamin D are essential for bone health at all ages but low levels of~     vitamin D may also negatively impact other aspects of health such as blood pressure. The~     investigators have previously shown that adults with African ancestry living near the equator~     have much higher levels of vitamin D and higher levels of blood pressure compared to adults~     with African ancestry living in the Chicago area. Multiple clinical trials have examined~     vitamin D supplementation for reducing blood pressure levels but very few studies have~     focused on adults with African ancestry and low vitamin D levels. In addition, most previous~     clinical trials have not addressed calcium intake. While vitamin D may modulate blood~     pressure via its actions on activation of the renin angiotensin aldosterone system, it is~     also possible that vitamin D mediates blood pressure via its effects on gastrointestinal~     calcium absorption. This pilot study is a one arm study, which will assess the safety and~     feasibility of supplementing 15 young adults with African ancestry and low vitamin D levels~     with 5,000 IU of Cholecalciferol (vitamin D3) combined with 1000 mg of elemental calcium~     daily for 3 months. Participants will be recruited from the Maywood Illinois and surrounding~     areas with flyers and brochures. The investigators will also contact previous participants of~     the Modeling the Epidemiologic Study/Vitamin D Ancillary Study by phone and letters. At~     baseline, all participants will have blood pressure measured and will provide a fasting serum~     specimen and a 24-hour urine collection. Calcium, parathyroid hormone level vitamin D will be~     measured in serum specimens and 24-hour urine calcium excretion will be measured. Repeat~     visits will be completed at 6 and 12 weeks of follow-up to again measure resting blood~     pressure and serum calcium and vitamin D levels. The overall goal is to collect pilot data to~     help design a larger trial of vitamin D and calcium supplementation for lowering blood~     pressure in young adults with African ancestry.~   "
37906|NCT03070470|"~     This study will assess whether exposure response analysis of the electrocardiographic QTc and~     J-Tpeakc intervals in Phase 1 clinical pharmacology studies can be used to confirm that drugs~     that predominantly block the potassium channel encoded by the human ether-à-go-go-related~     gene (hERG) with approximately equipotent late sodium and/or calcium block (balanced ion~     channel drugs) do not cause J-Tpeakc prolongation and that drugs that predominantly block~     hERG without late sodium or L-type calcium current block (predominant hERG drugs) cause QTc~     prolongation.~   "
37907|NCT03070457|"~     Evaluate the safety and efficacy of an early discharge protocol (23 hours, overnight stay)~     after scheduled sleeve gastrectomy.~   "
37908|NCT03070444|"~     The purpose of this trial is to evaluate and compare stability after orthodontic treatment~     with an Essix retainer and a bonded cuspid-to-cuspid retainer (CTC), respectively in the~     mandibular arch and longitudinally follow these patients over time up to 5 years. The~     patients' perceptions of the two methods are also evaluated with questionnaires during the~     follow-up period.~      A further aim of this study is to analyze the relationship between diagnosis, treatment~     outcome, treatment time, age at start of treatment and stability with an Essix retainer in~     the maxilla.~      The null hypotheses are:~        -  that there is no difference in retention capacity between Essix retainer and~          cuspid-to-cuspid retainer~        -  that there is no difference in patients' perception between Essix retainer and~          cuspid-to-cuspid retainer~        -  that there is no difference in retention capacity for Essix retainer in the maxilla~          concerning diagnosis before treatment, treatment outcomes, treatment time and age at~          start of treatment~   "
37909|NCT03070431|"~     The major goal of this clinical study is to investigate to which extent high-precision~     radiotherapy (RT) with modern techniques can prevent progression or recurrence of motor~     deficits (weakness) of the legs following RT. In addition, it will be evaluated to which~     extent RT can lead to improvement of motor function, ambulatory status, sensory function and~     sphincter dysfunction, to pain relief and to improvement in quality of life, side effects and~     overall survival. For this purpose 44 patients who will receive modern high-precision RT~     treatment for the metastases on their vertebral bodies will be included into this phase 2~     study. The results of the high-precision RT with a treatment of 5x5 Gray (Gy) in 1 week will~     be compared to data of a historical control group. The data set of the historical control~     group consists of more than 500 patients who received conventional RT with 5x4 Gy. The data~     collected in 1 week treatment will be compared. It is intended to show superiority regarding~     the local progression-free survival (LPFS) for the high-precision RT when compared with the~     conventional RT.~   "
37910|NCT03070418|"~     Femoral cervical fractures fixation with DHS plate throw 3 cm incision and minimum surgical~     trauma.~   "
37911|NCT03070405|"~     The main purpose of this study is to evaluate whether PAS will change the PK parameters of~     tenofovir.~   "
37912|NCT03070392|"~     To evaluate the overall survival of HLA-A*0201 positive adult patients with previously~     untreated advanced UM receiving IMCgp100 compared to Investigator's Choice of dacarbazine,~     ipilimumab, or pembrolizumab.~   "
37913|NCT03070379|"~     At recent, the number of patients who underwent sedated esophagogastroduodenoscopy has been~     on the increase. For such patients, whether topical pharyngeal anesthesia is needed remains~     to be controversial. European Society of Gastrointestinal Endoscopy, European Society of~     Gastroenterology and Endoscopy Nurses and Associates, and the European Society of~     Anaesthesiology Guideline for non-anesthesiologist administration of propofol for GI~     endoscopy have not made any recommendation, because the role of pharyngeal anesthesia during~     propofol sedation for upper digestive endoscopy has not been assessed. Our study aimed at~     investigating whether topical lidocaine pharyngeal anesthesia could benefit patients who~     underwent esophagogastroduodenoscopy under propofol sedation.~   "
37914|NCT03070366|"~     The aim of this study is to evaluate the rate of living patients at 1 year with a quality of~     life criteria (no decrease) and reduced toxicities. This criteria will be compared in both~     groups., A cost effectiveness study is scheduled also.~   "
37915|NCT03070353|"~     A pilot study of Dextran-40 infusion in patients with decompensated cirrhosis presenting with~     AKI~   "
37921|NCT03070275|"~     Systemically healthy volunteers with no active periodontal disease are recruited from~     referrals to the Dept. of Preventive Dentistry, Periodontology and Biology of Implants,~     Aristotle Univ of Thessaloniki for implant therapy. After signing a consent form,~     participants will be randomized into two treatment groups. Group-A (NA=10) will receive~     crestal placement of implants following a two-stage protocol in combination with a biocomplex~     comprising autologous alveolar bone marrow mesenchymal stem cells free of animal derived~     reagents, produced in clean room facilities and seeded into collagen scaffolds enriched with~     autologous fibrin glue. In Group-B (NB=10) implants are placed on the alveolar crest~     following a two-stage protocol and the manufacturer's guidelines. Intra-surgical clinical and~     radiographic assessments are performed at the time of implant placement (T0) and at the~     two-stage surgery (T1). Changes in mucosa thickness, width of keratinized tissues, marginal~     bone and bone thickness at the surgical site will be determined at T0-T1. Groups will be~     further divided into two subgroups based on mucosal thickness of the surgical site at T0~     [thin mucosa (≤2.5mm) for Groups-AI/-BI; thick mucosa (>2.5mm) for Groups-AII/-BII]. A linear~     mixed model for repeated measures will be used for data analyses to determine changes in the~     dimensions of the peri-implant soft and hard tissues, around two stage-implants placed either~     conventionally, or in combination with the biocomplex.~   "
37922|NCT03070262|"~     Caffeic acid can target inhibit GASC1 expression and GASC1 is confirmed to be a new oncogene~     in several cancers including esophageal cancer. This study aims to investigate the efficiency~     and safety of coffeic acid in chinese advanced esophageal squamous cell cancer (ESCC).~   "
37923|NCT03070249|"~     This study will assess compassion fatigue among healthcare providers in a single emergency~     department (ED) using the Professional Quality of Life (ProQoL) scale.~   "
37924|NCT03070236|"~     This research study is evaluating how patients feel physically and emotionally after a prior~     breast biopsy for specific breast conditions (including atypical lesions such as atypical~     ductal hyperplasia (ADH), atypical lobular hyperplasia (ALH), lobular carcinoma in situ~     (LCIS), and/or ductal carcinoma in situ (DCIS))~   "
37925|NCT03070223|"~     Aging with HIV may be related to an earlier development of frailty (weakness) or disability,~     including difficulties in tests of strength or walking speed. Few treatments have been shown~     to prevent or slow these impairments in people with or without HIV. Some studies have~     suggested that the class of drugs called statins (for example, pitavastatin) might be helpful~     in slowing frailty or disability. This might happen by decreasing fat within the muscle or by~     decreasing inflammation markers (substances in the blood that determine how the body reacts~     to infection or irritation) in the blood. Other studies have shown that statins increase the~     risk of muscle aches and pains. This substudy is being done to determine the impact of the~     drug pitavastatin on muscle.~   "
37926|NCT03070210|"~     AIM: To compare pain relief in patients randomly assigned to endoscopic ultrasound-guided~     celiac ganglia block (EUS-CGB) vs standard endoscopic ultrasound-guided celiac plexus block~     (EUS-CPB).~      METHODS: This is a single-center, double-blind, randomized parallel-group study to assess the~     efficacy of EUS-CPB vs. EUS-CGB in patients with painful chronic pancreatitis.~   "
37927|NCT03070197|"~     Approximately 400 Congenital heart disease patients will participate in the research study~     which will include one or more research visits for neurodevelopmental testing, brain MRI, and~     collection of medical history including previously collected genetic sequencing results. The~     investigators will explore the association between genetic variants, neurodevelopmental~     deficits, and brain MRI endophenotype. Analyses will compare groups with and without~     deleterious de novo mutations.~   "
37928|NCT03070184|"~     The purpose of the study is to understand the origins of differential response to~     beta-blockers in African-Americans and may provide insight regarding racial differences in~     cardiovascular risk.~   "
37929|NCT03070171|"~     The primary objective of this trial is to establish the bioequivalence of tablet formulation~     of dabigatran etexilate compared to commercial capsule formulation following oral~     administration under fasted condition.~      The secondary objective is the evaluation and comparison of several pharmacokinetic~     parameters between the treatments.~   "
37930|NCT03070158|"~     This experimental study will determine the effectiveness of nursing intervention the~     attachment promotion to increase the affective bonds between mothers and their premature~     infants. The assignment of the mothers to the control group will receive usual care, the~     mothers will be assigned to intervention group will receive the intervention.~   "
37931|NCT03070145|"~     This research study is evaluating the impact and feasibility of a 12-week brisk walking and~     moderate strength training exercise intervention including a virtual component in men who are~     initiating androgen deprivation therapy (ADT) for prostate cancer~   "
37932|NCT03070132|"~     The primary objective of the study is to evaluate the efficacy of BIIB074 in treating pain~     experienced by participants with trigeminal neuralgia (TN). Secondary objectives of this~     study are to investigate the safety and tolerability of BIIB074 in participants with TN and~     to evaluate the population pharmacokinetics (PK) of BIIB074.~   "
37933|NCT03070119|"~     The primary objective of the study is to evaluate the long-term safety and tolerability of~     BIIB067 in participants with Amyotrophic Lateral Sclerosis Caused by Superoxide Dismutase 1~     Mutation (SOD1-ALS). The secondary objective is to evaluate the pharmacokinetic (PK) profile~     of BIIB067 in participants with SOD1-ALS.~   "
37934|NCT03070106|"~     A Functional Medicine (FM) approach to diabetes care focuses on identifying and treating the~     etiologies for imbalances in the core physiological systems.(1) If underlying triggers and~     imbalances can be identified, the FM approach to addressing root causes(1) can be utilized~     through the use of specialized testing to treat and potentially reverse diabetes. If the FM~     approach is successful, the impact on diabetes disease burden as well as diabetes-associated~     health care costs could be significant. This project will assess the clinical as well as cost~     effectiveness of a FM approach to diabetes care compared to a usual care approach for~     patients with diabetes on insulin for 5 years or less.~   "
37935|NCT03070093|"~     The purpose of this study is to provide expanded access to ASP2215 for subjects with~     FLT3-mutated relapsed or refractory AML or FLT3-mutated AML in composite complete remission~     (CRc) (complete remission [CR], complete remission with incomplete hematologic recovery~     [CRi], complete remission with incomplete platelet recovery [CRp]) with MRD without access to~     comparable or alternative therapy.~   "
37937|NCT03070067|"~     A clinical decision support rule/tool for classification of TIA/mimic that will enable rapid~     detection of ACVS in hyper-acute settings is being developed. Also under development is a~     multi-protein test using mass spectrometry (MS). This test will provide TIA results within an~     hour or two for a fraction of the price of neuroimaging. With guidance provided by this test~     at their disposal, physicians can inform patients whether they can go home safely or whether~     they need further testing. The right patients will receive the right treatment, reduce~     unwarranted imaging risks and costs, and reduce the burden of stroke. The Heart and Stroke~     Foundation will work to ensure that physicians, allied healthcare providers, the public and~     other stakeholders are aware of the outcomes and clinical impacts of this project.~      Further, work is being done to establish the mechanisms to develop a strong phenotype for TIA~     that includes medical imaging (MRI), cardiac monitoring, cognitive assessments, and~     surveillance of health outcomes for extended periods of time.~   "
37938|NCT03070054|"~     The investigator's are conducting a randomized, blinded study to determine if the~     extra-capsular local infiltration analgesic (LIA) administration of 20ml 0.25%~     bupivacaine-epinephrine can improve the postoperative pain management of hip arthroscopy~     patients. Participants will be randomly assigned to the LIA group or non-LIA group prior to~     surgery. Participants, anesthesiologists and PACU nurses will be blinded to group assignment,~     however the surgeon administering the LIA will be unblinded.~   "
37939|NCT03070041|"~     The impact of Baby-friendly Hospital Initiative (BFHI) to breastfeeding, breastfeeding~     counselling and breastfeeding attitudes will be examined in Satakunta Central Hospital,~     Finland. The baseline measurement will be conducted before the implementation of BFHI in 2017~     and second measurement will be conducted in 2019 after the certification process. Both staff~     members and breastfeeding mothers will be recruited in the study. The main outcomes are the~     duration of breastfeeding and breastfeeding attitudes.~   "
37940|NCT03070028|"~     Patients with pilonidal sinus disease will be randomised to two groups (crystallised phenol~     and platelet rich plasma). Sinus healing time, patient satisfaction, complications and~     recurrence rates will be compared.~   "
37941|NCT03070015|"~     The primary purpose of this study (Part A) is to assess changes in body weight and body~     circumference parameters that are achievable after 4 weeks on the Nutrisystem program~     compared to a self-directed diet (i.e. Dietary Approaches to Stop Hypertension or DASH). In~     Part B, subjects on the Nutrisystem program will be given the option to continue the program~     for another 8 weeks.~   "
37942|NCT03070002|"~     The purpose of this study is to look at the amount of cancer cells in the blood of~     participants who are being treated with denosumab. The other purpose is to look at how long~     it takes for cancer to get worse when participants are being treated with denosumab.~     Circulating tumor cells (CTCs) in the blood of patients with metastatic breast cancer (MBC)~     have been associated with shorter survival than when CTCs are absent, especially in patients~     whose cancer has spread to their bones. In this study, we want it see if denosumab (the study~     drug) will decrease the number of CTCs measured in patients with MBC and cancer that has~     spread to their bones. We also plan to get blood from participants to study other research~     markers of interest.~   "
37943|NCT03069989|"~     GSK3008348 is being developed as a treatment for IPF. A first-time-in-human study showed that~     single nebulized doses of 1−3000 micrograms (mcg) GSK3008348 in healthy volunteers were well~     tolerated, with pharmacokinetic (PK) exposures within the defined limits set in the protocol.~     The proposed study is a 2-cohort study of single doses, intended to evaluate the safety,~     tolerability and PK of the drug in participants with IPF not currently treated with~     pirfenidone or nintedanib, and to obtain preliminary information on target engagement. Cohort~     1 will be a 2-period, randomized, double-blind, placebo-controlled group with at least 7 days~     washout between doses, and follow-up period of up to 7-14 days. Cohort 2 is optional. It will~     be designed to further explore safety and to provide additional information on the target~     engagement profile of GSK3008348. The total duration of the study will be up to 62 days.~   "
37944|NCT03069976|"~     Based upon the possible implication of microbiota and abnormal microbial metabolites such as~     altered bile acids, in the pathogenesis of PSC, emerging data suggests that oral antibiotics,~     such as vancomycin and metronidazole, may have therapeutic effects in this overlap syndrome~     or PSC.~      The goal of our study is to evaluate role of antibiotics and microflora in children with~     AIH/PSC overlap syndrome or with PSC alone. The investigators hope to learn what effects oral~     antibiotics has on the bacteria present in stool, and hope to learn to characterize human~     intestinal microbial communities, in children suffering from overlap syndrome or PSC.~      The hypothesis of the investigators is that overlap syndrome and PSC develop due to altered~     microflora and the resulting abnormal bile acids pool. The outcome of overlap syndrome or PSC~     could be affected by presence or absence of RCUH. Antibiotics to correct the microflora may~     result in disease/cholangiopathy remission.~   "
37945|NCT03069963|"~     Primary Objective:~      Pharmacodynamics: assessment by pH metry of the change in gastric pH (antacid activity) of~     Z0063, in comparison to the effect of Gaviscon Double Action Tablets, in healthy adult~     subjects.~      Secondary Objective:~      Safety: assessment of the clinical safety of Z0063, and Gaviscon Double Action Tablets, in~     healthy adult subjects.~   "
37946|NCT03069950|"~     The purpose of this study is to see if patients treated with both regional chemotherapy using~     the HAI pump and intravenous chemotherapy are able to have their liver tumors removed~     surgically (resected), versus treatment with only intravenous chemotherapy.~   "
37947|NCT03069937|"~     The purpose of this study is to look at patient outcomes when docetaxel is started prior to~     ADT with degarelix.~   "
37948|NCT03069924|"~     This research is a randomized smoking cessation trial conducted within and specifically~     personalized for lung cancer screening patients presenting to a lung screening clinic. Novel~     tobacco treatments for this population are critically needed, given the growing population of~     lung screening patients, which will grow dramatically now that lung screening is an approved~     CMS benefit. In the proposed study, we will test a gain-framed messaging intervention~     specifically designed for lung screening patients (vs. unframed messaging), as well as~     evaluating NRT sampling (vs. no medication) at 2 study sites. Our project is designed to be~     translational (in that it can be transferable from our controlled efficacy study to other~     lung screening programs).~   "
37950|NCT03069898|"~     With an emphasis on 12 3-hour group workshops, the TRUE Dads fatherhood intervention program~     focuses on establishing or strengthening three of men's key roles in the family: 1) their~     role as providers, through fostering employment and economic self-sufficiency, 2) their role~     as fathers, in building and maintaining positive engagement with their children, and 3) their~     role in having and keeping a positive relationship with their co-parenting partner (wife,~     intimate partner, or other co-parent). The study is a randomized clinical trial that compares~     participants in a program track with participants a study track (no treatment control group)~     over a one-year period.~   "
37951|NCT03069885|"~     Due to the Danish breast cancer-screening programme and the increased use of genetic~     counselling, Danish women are being diagnosed with breast cancer, or a high lifetime risk of~     developing breast cancer, at a younger age than previously. An increasing proportion of these~     women pursue an immediate breast reconstruction, where the breast is removed and~     reconstructed in a single surgical procedure.~      As some of these women will need to undergo adjuvant cancer therapy after their breast~     surgery, fast recovery is essential in order for the adjuvant therapy not to be delayed. With~     the development of new surgical techniques, the complication rate to the immediate breast~     reconstructions has improved. However, wound-healing issues remain one of the most common~     complications to the surgery with the possibility of delaying the adjuvant therapy and~     diminish the aesthetic result.~      Incisional negative pressure wound therapy (iNPWT), is a new approach for surgical site~     closure. Recently, iNPWT has shown promising results in lowering post-operative~     complications, including wound-healing issues, in other surgical settings. However, iNPWT has~     still not been studied in an immediate breast reconstructive setting.~      The current randomized controlled clinical study will investigate if an iNPWT system, is able~     to provide women seeking an immediate breast reconstruction with faster healing and superior~     aesthetic results compared to the conventional post-operative wound dressings used today. The~     investigators plan to include 60 women, randomized in a 1:1 ratio between iNPWT or~     conventional wound dressing. The primary outcome measure is the time until removal of the~     surgical drains, which corresponds to the healing progression. Secondarily, complications to~     the surgery, assessment of the scar (measured using the Patient and Observer Scar Assessment~     Scale) and patient reported satisfaction with the reconstruction (assessed using the BREAST-Q~     questionnaire) will be performed. Included patients are examined pre-operatively, and at the~     routine controls at four weeks and four months post operatively.~      The results from the current study will elucidate if iNPWT aids wound healing after immediate~     breast reconstruction, which would lead to fewer patients experiencing delays before their~     adjuvant therapy. Furthermore, the results from the aesthetic satisfaction will elucidate if~     iNPWT provides the patients with a better self-reported aesthetic result.~   "
37952|NCT03069872|"~     Background~      Ovarian cancer (OC) is a disease with a poor prognosis due to diagnosis at late stage.~     Early-stage OC presents with non-specific and vague symptoms and therefore OC usually is not~     detected until reaching an advanced stage. From 2008, Danish general practitioners (GPs)~     could urgently refer patients suspected of having OC to standardized cancer patient pathways~     (CPPs). The CPP is designed for women presenting specific signs and alarm symptoms, and is~     supposed to shorten the pathway from suspicion to treatment.~      Hypothesis~      Direct access to fast transvaginal ultrasound (TVU) through general practice is feasible in~     earlier diagnosis of OC.~      Aim~      The aim of this study is to assess the implementation and clinical implications of direct~     referral access to fast TVU through general practice.~      Materials and methods~      The study is a feasibility study and GPs from in Central Denmark Region are offered direct~     access to fast TVU for women aged 40 years or more who present symptoms that could origin~     from OC, but which are not classified as alarm symptoms. The GPs will receive education about~     updated knowledge on OC symptoms and the use of the guideline for earlier diagnosis of OC in~     general practice. The study period is 1 year.~      Perspectives~      There is a great need to test rational strategies for diagnosing OC at an earlier stage in~     order to improve survival. For women who do not fulfil access criteria for the CPP, and for~     whom the main prospect for earlier diagnosis is improved identification of symptomatic OC,~     this study may provide important new knowledge of how to facilitate the diagnostics of OC in~     the future and reduce time to diagnosis and improve survival.~   "
37953|NCT03069859|"~     Postpartum hemorrhage (PPH) occurs in up to one in ten deliveries worldwide and is the~     leading cause of maternal morbidity and mortality. In developing countries 30% of women~     develop PPH because access to a number of treatments is not readily available. Interestingly,~     the rate of PPH and consequently of maternal morbidity has increased significantly even in~     developed nations, such as Canada, over the past decades. This rate is also increasing~     amongst parturients in Ontario. Unfortunately, few effective preventative treatments exist.~      Antifibrinolytic drugs are routinely used to reduce bleeding and the requirement for blood~     transfusions in a wide range of hemorrhagic conditions. The most commonly used~     antifibrinolytic drug is tranexamic acid (TXA). TXA is safe, affordable, with very few side~     effects. The World Health Organization recommended that TXA be used to reduce blood loss in~     several conditions, including in patients with established PPH refractory to conventional~     therapy.However, little is known about the prophylactic use of TXA to prevent PPH.~   "
37954|NCT03069846|"~     The primary objective is to collect emission spectra of normal tissue, pigmented normal~     lesion, benign lesion, SCC, BCC and melanoma to construct the database and validate the~     classifying algorithm.~   "
37955|NCT03069833|"~     An NBI-based diagnosis requires training and experience. We are developing a system of~     computerized image recognition, which can detect possible NBI features of polyps, and provide~     a more objective diagnosis, which allows nonexpert endoscopists to achieve a high diagnostic~     accuracy.~   "
37956|NCT03069820|"~     The most common toxicity of TP (docetaxel and cisplatin) chemotherapy is chemotherapy-induced~     liver injury. However, patients don't always experience same chemotherapy-induced liver~     injury for the same drugs. Therefore, the investigators designed the present study to clarify~     risk factors associated with the development of severe hepatotoxicity after therapy with~     docetaxel and cisplatin for nasopharyngeal carcinoma (NPC).~   "
37957|NCT03069807|"~     This study investigates whether recent migrants to the United Kingdom are more likely to~     complete treatment for Latent Tuberculosis Infection (LTBI) if they are treated in the~     community (by General Practitioners/Family Doctors and pharmacists) than in a hospital TB~     clinic.~   "
37958|NCT03069794|"~     Many studies are in favour of the importance of the rachis on the postural balance of the~     body.It is possible to study the upright posture by determining the center of pressure using~     a platform of strength.The spinal surgery have two objectives ,mechanic and neurologic .By~     deformation correction and stabilizing vertebral stages via arthrodesis, it seems to~     hypothesize that surgery can modify postural balance.~      This study aim to evaluate spinal surgery effect on posture using that plaftorm .~   "
38034|NCT03068806|"~     This is a research study designed to examine how the psychiatric illness called schizophrenia~     affects brain function and thinking abilities such as attention and memory during simple~     computer-based tasks, and how measures of brain function are related to performance. We do~     this by looking at brain activity using electroencephalography (EEG) and magnetic resonance~     imaging (MRI). We compare participants' results to the activity in their brain as well as~     clinical measures and questionnaires also completed during this study.~   "
37959|NCT03069781|"~     The maintenance of skeletal muscle mass and function is critical for healthy aging. Muscle~     loss with disuse, termed muscle disuse muscle atrophy, leads to impaired functional capacity,~     the onset of insulin resistance, as well as a heightened risk for morbidity and mortality.~     With advancing age there is a chronic wasting of muscle. This is especially true in women,~     where rapid rates of decline in muscle mass and greater anabolic resistance are experienced~     around the time of menopause, despite higher protein synthesis rates. As women have a longer~     life expectancy, they are particularly venerable to age-related frailty and morbidity.~      Skeletal muscle protein turnover serves to maintain the optimal function of proteins and also~     provides plasticity of the tissue during altered demands such as during increased loading or~     unloading of the muscle. Reduced periods of physical activity also have a similar, albeit~     milder, impact on skeletal muscle and most, people will likely experience multiple bouts of~     skeletal muscle disuse during their lifetime from which some, particularly older adult women,~     will fail to fully recover. Thus, muscle disuse atrophy is a significant and continuing~     problem as reclamation of lost muscle mass, strength/function, and potentially metabolic~     health (particularly insulin-induced glucose disposal), following disuse is oftentimes~     incomplete and may be further exacerbated after menopause.~      Previous evidence has demonstrated that in the loss of muscle mass is less pronounced in~     post-menopausal women when receiving hormone replacement therapy. Skeletal muscle has~     estrogen-β-receptors on the cell membrane, in the cytoplasm and on the nuclear membrane, and~     therefore a direct mechanistic link between low estrogen levels and a decrease MPS.~     Interestingly, despite higher rates of protein synthesis, older women still lose muscle mass~     with advancing age. It has been suggested that the negative muscle protein balance is due to~     an enhanced rate of MPB. Insulin is a potent inhibitor of MPB and estrogen has been shown to~     enhance insulin sensitivity in skeletal muscle. However, to our knowledge, no study has~     examined the efficacy of estrogen supplementation to attenuate the losses of skeletal muscle~     mass and function during a period of disuse. The findings of this investigation may yield~     critical data for those who wish to combat skeletal muscle disuse atrophy, particularly after~     menopause.~   "
37960|NCT03069768|"~     The primary aim of this study is to conduct a 60-patient feasibility, acceptability, and~     preliminary efficacy study of mSMART (Mobile App based Personalized Solutions and Tools for~     Medication Adherence of Rx Pill), a smartphone application (app) for improving medication~     adherence among substance users. The investigators will compare 2 groups of cigarette smokers~     undergoing a quit attempt with varenicline (Chantix): a) an experimental group using the~     mSMART app on their smartphone and a MEMS Cap (Medication Event Monitoring System, a smart~     pillbox that will a record a date and time-stamped medication event whenever pill box is~     opened and closed, and thus allow for primary measurement of medication adherence) and b) a~     control group using the MEMS Cap and mobile web-based surveys on their smartphone.~   "
37961|NCT03069755|"~     This study aims to estimate the perioperative mortality rate in adult trauma patients~     undergoing acute surgery as well as the association between type of acute surgery and~     perioperative mortality in university hospitals in urban India.~   "
37962|NCT03069742|"~     The purpose of this randomized controlled trial (RCT) is to evaluate a decision support~     website (RealRisks) designed to inform patients about breast cancer prevention options. It is~     coupled with a physician-centered (BNAV) decision support website as part of clinical~     workflow in the primary care setting. The investigators hypothesize that improving accuracy~     of breast cancer risk perception and understanding of the risks and benefits of breast cancer~     risk lowering drugs, also known as chemoprevention, will increase the uptake of~     chemoprevention in the primary care setting.~   "
37963|NCT03069729|"~     The goal of this research is to develop better tools for diagnosing illness of the feet and~     legs of people who have diabetes. Investigators will use thermal videos of the foot to aid in~     the refinement of a system designed to detect signs of diabetic peripheral neuropathy (DPN).~     The team of investigators will also look at diabetic eye disease and how it might relate to~     diabetic foot disease.~   "
37964|NCT03069716|"~     This study proposes the use of a mobile health intervention (utilizing a smart phone app) to~     encourage increased exercise in PAH patients. The study will be a randomized trial to examine~     feasibility of an mHealth (mobile device) Fitbit Charge HR and cell phone application~     intervention to improve step counts and increase participants activity level as compared to~     no intervention. The Fitbit Charge Heart Rate (HR) monitors activity and the cell phone~     application provides encouragement notifications to half the subjects while the other half do~     not receive encouragements.~   "
37965|NCT03069703|"~     The study hypothesis is that a reinforced pneumococcal combined vaccine strategy in~     patients with ANCA-associated vasculitides treated with rituximab will induce a better immune~     response than the current standard regimen, with an acceptable safety profile.~      This study therefore aims at evaluating the immunogenicity and safety of two reinforced~     innovative pneumococcal vaccine regimen [one double dose at day0 and one double dose at day7~     or a quadruple dose of 13-valent anti-pneumococcal conjugate vaccine (PCV13) followed by one~     dose of 23-valent unconjugated vaccine (PPV23) at month 5], compared to the standard regimen~     (one dose of PCV13 followed by one dose of PPV23 at month 5), in patients with~     ANCA-associated vasculitides receiving rituximab therapy.~   "
37966|NCT03069690|"~     This study will evaluate the impact of different combinations of intervention as a function~     of gestational weight gain in pregnant woman. Participants will be randomized at two points~     during the study. Participants will first be randomized at enrollment to receive study~     intervention during pregnancy or treatment as usual. Participants will also be randomized~     just before delivery to receive intervention postpartum or treatment as usual.~   "
37967|NCT03069677|"~     The purpose of this study is to determine if there are differences in anxiety scores, heart~     rate, blood pressure, and oxygen status when using sedation medication versus music while~     undergoing a peripheral nerve block before your surgery.~   "
37968|NCT03069664|"~     Patients with pancreatic cancer often suffer from chronic abdominal pain, weight loss and~     decreased quality of life. The patients also often need pancreatic enzyme supplements. In~     this prospective study the aim is to see whether patients undergoing palliative pancreatic~     duct drainage will experience less chronic abdominal pain and a higher quality of life than~     patients with the same diagnosis without the procedure. The study also investigates whether~     the nutritional state of the patients with palliative stents remains better than in the~     control group.~   "
38035|NCT03068793|"~     The purpose of this study is to examine the nature of reward processing dysfunctions in~     schizophrenia using neuroimaging techniques that capture in vivo brain functioning, such as~     EEG and fMRI.~   "
38229|NCT03066271|"~     The aim of this study is to evaluate the feasibility and the effect of daily, individual,~     supervised and structured exercise training before radiotherapy in patients diagnosed with~     Non-Small Cell Lung Cancer. Primary outcome is maximal oxygen uptake (VO2peak). The~     hypotheses are that patients who undergo daily exercise training will increase VO2peak,~     functional capacity (measured by 6-minute walk test (6MWD)) and lung function (forced expired~     volume in one second (FEV1)).~   "
37969|NCT03069651|"~     Cystic fibrosis (CF) is the most common fatal inherited condition in Caucasians, causing~     recurrent chest infections (pulmonary exacerbations). People with CF experiencing pulmonary~     exacerbation often require a 14day course of intravenous antibiotics and this treatment can~     either be delivered in hospital or in the community. Patients admitted to hospital are seen~     regularly by members of the CF multidisciplinary team (MDT), including doctors, nurses,~     dieticians and physiotherapists. This allows patients' progress to be closely monitored and~     also gives patients the opportunity to discuss any concerns or questions. In contrast,~     patients receiving IV antibiotics in the community are only seen by the MDT at the beginning~     and end of their 14 day course of IV antibiotics. Although CF nurses often visit patients on~     12 occasions during the course of treatment, patients are not routinely reassessed by the~     rest of the MDT. There is therefore less opportunity for the MDT to adjust patients'~     treatment and for patients to communicate with the MDT.~      We therefore aim to study whether patients receiving IV antibiotics in the community benefit~     from monitoring their own oxygen saturations and lung function, as well as taking part in~     twice-weekly videoconferences with the MDT ('virtual care'). We expect that this will enable~     the MDT to to assess patients' progress more closely and allow patients to communicate with~     the MDT more easily. We will assess whether this improves patients' experience of their care~     and whether this translates into improvements in health and economic outcomes.~      One hundred subjects will be recruited over a 12month period, with 50 subjects allocated to~     'virtual care' and 50 subjects allocated to 'routine care'. Subjects receiving 'routine care'~     will receive usual clinical care.~      The research team are well placed to perform the study because we are part of a large CF~     centre with an excellent record in clinical research.~   "
37970|NCT03069638|"~     The main objective of this study is to evaluate the effectivity of intranasal dexmedetomidine~     sedation during intra-articular injection therapy. Intranasal dexmedetomidine is compared~     with dinitrous oxide (N2O) which has already been proven safe and effective sedation method~     during painful procedures in pediatric patients.~      In earlier studies the median VAS during intra-articular corticosteroid injections with~     patients receiving nitrous oxide has been 3 (Uziel et al 2008). Study hypothesis is that with~     intranasal dexmedetomidine sedation the VAS pain levels will be 1 unit lower.~   "
37971|NCT03069625|"~     Cystic fibrosis (CF) is a chronic hereditary respiratory disease. Exercise testing is part of~     CF patients regular assessment.~      Cardio-Pulmonary Exercise Testing (CPET) is currently considered as the gold standard to~     assess physical capacities. However, simple field tests are emerging. These tests are easier~     to perform especially in a population of CF children and adolescents.~      The 1minute Sit-To-Stand test have recently been evaluated in CF adults. This test correlates~     with maximal oxygen consumption during CPET.~      The investigators hypothesized that this test also correlates with 6-Minute Walking distance~     (during a 6-min Walk Test), quadriceps strength, respiratory muscles strength and~     health-related quality of life.~   "
37972|NCT03069612|"~     Cannabis use during adolescence represents a significant risk factor for the development of~     psychosis including schizophrenia. Moreover, cannabis is the most commonly used drug among~     patients with an existing psychotic disorder. An estimated 25% of patients with psychosis~     reportedly meet the criteria of a cannabis use disorder particularly among younger patients~     experiencing their first episode. Cannabis use significantly exacerbates symptomatology~     resulting in an increased duration of the first hospitalization visit, number of hospital~     readmissions, and overall reduced functional outcome. Discovering novel strategies to treat~     the underlying pathophysiology of cannabis dependence early in the disorder may translate~     into improved functional outcome. Working memory deficits have been shown to predict relapse~     in the first-year of psychosis and is modulated with cannabis use. Repetitive transcranial~     magnetic stimulation (rTMS) targeted to the dorsolateral prefrontal cortex (DLPFC) has shown~     tremendous promise for the treatment of both tobacco dependence and working memory impairment~     in patients with psychosis possibly through the modulation of gamma (30-50 Hz) oscillations.~     The proposed study will therefore evaluate the effect of rTMS on abstinence, working memory~     performance, and gamma oscillations through a randomized, double-blind, placebo-controlled~     28-day longitudinal abstinence study design in patients with early psychosis. It will further~     explore if baseline performance and gamma oscillations predict abstinence in response to~     rTMS. It is hypothesized that active compared to sham rTMS will improve abstinence rates and~     improve working memory performance through the modulation of gamma oscillations.~   "
37973|NCT03069599|"~     The aim of this project is to describe the differential immunologic responses of patients who~     undergo in situ IRE, margin accentuation IRE with surgical resection of the primary tumor,~     and surgical resection of the primary tumor only. The primary hypothesis is that IRE induces~     a long and sustained activation of the cell-mediated immune system, which is distinct from~     the immune response after surgical resection only. The primary endpoint of this study is the~     comparison of the CD4+/CD8+ ratio as an indicator of antitumor immunity both longitudinally~     within a group after the intervention and over time between the three groups. CD4+/CD8+ ratio~     will be measured preoperatively and at postoperative days 1, 7, 42, and 180. As a secondary~     outcome, additional measurements will be taken to more specifically characterize the immune~     response based on peripheral blood samples. Flow cytometry will be used to quantify cell~     subsets, and ELISA will be used to measure cytokine levels , at the same time-points as for~     the primary outcome. Each group of patients as described above will consist of 10 consecutive~     pancreatic cancer patients. Patients aged 18 or older with resectable, borderline resectable,~     or locally advanced pancreatic cancer will be included. Patients with locally advanced~     disease will undergo 3 months of preoperative chemotherapy with monitoring to exclude~     metastatic disease. Main exclusion criteria are cardiac conduction abnormalities and signs of~     distant metastasis.~   "
37974|NCT03069586|"~     The investigators want to test the hypothesis that the addition of a recruitment manoeuvre to~     a low pressure pneumoperitoneum will lead to an additional reduction in postoperative pain.~     Therefore the investigators will conduct a prospective randomized controlled, single blind~     trial.~   "
37975|NCT03069573|"~     The purpose of this study is to find out some potential biomarkers for the Eosinophilic~     Esophagitis (EoE) in pediatric patients through the prospective clinical characterization and~     assessment of samples collected during the diagnostic process~   "
37976|NCT03069560|"~     Assessment of the feasibility of a monitoring device by SMS in which messages are sent by the~     caregiver after a suicidal act.~   "
38063|NCT03068429|"~     24 OCD patients and 24 healthy subjects will be submitted to a two-day fear conditioning~     paradigm during acquisition of functional magnetic resonance imaging (fMRI). OCD patients~     will be submitted to the paradigm at two timepoints: baseline and 4 weeks after treatment~     initiation with sertraline up to 200mg/day or maximum tolerated dosage. OCD patients are~     expected to demonstrate worsened extinction retention compared to healthy subjects at~     baseline. Sertraline treatment is expected to improve extinction retention compared to~     baseline and to normalize the brain regions being recruited with the conditioned stimuli~     presented during the recall phase.~   "
37977|NCT03069547|"~     Patellofemoral Pain (PFP) is a common knee problem, primarily affecting adolescents and young~     adults. PFP is characterised by significant retropatellar and/or peripatellar pain and~     impairment of function and quality of daily life. Exercise therapy is unequivocally~     recommended as a core component of the management of PFP. Different exercise types (e.g.~     quadriceps strengthening, hip strengthening and functional/neuromuscular exercises) have been~     investigated, with knee and hip strengthening exercises as the most common and recommended~     types. These exercises approaches produce similar small to moderate effects on pain and~     physical function. However, the PFP population is very heterogeneous and~     one-size-fits-all-approaches presumably are sub-optimal because the heterogeneity is~     ignored. The heterogeneity probably explains the overall limited beneficial effects of~     exercise, and the lack of differences in direct comparisons of different exercise types. In~     that sense, it is not unlikely that certain patient characteristics may predict outcome~     success of either a hip training program or a training program that focus on the quadriceps~     but this remains to be shown.~      This study has two aims:~        1. To assess the comparative effectiveness of two different exercise programs (Quadricep~          Exercise [QE] vs. Hip Exercise [HE]) on self-reported pain and function in individuals~          with PFP.~        2. To explore candidate patient characteristics that predict differential responses to the~          two exercise programs (QE vs HE) on self-reported pain and physical function in~          individuals with PFP.~      According to the study aims we pursue the following hypothesis:~      - QE and HE have equivalent efficacy on self-reported pain after 12 weeks of treatment in~     patients with PFP.~      The second study aim is to explore possible candidate patient characteristics that may~     associate with differential outcomes. As this is exploratory, the pursuit of this aim is~     hypothesis-free.~   "
37978|NCT03069534|"~     Multidrug-resistant tuberculosis (MDR-TB) has emerged as a challenge worldwide. Few studies~     have prospectively reported outcomes in patients with pulmonary MDR-TB treated with~     adjunctive immunotherapy combined to standard chemotherapy. We aimed to assess whether~     immunotherapy with Interleukin(IL)-2 enhanced the clinical and immune effects of treatment on~     MDR-TB patients.We performed a multicentre prospective cohort study extend all over Jiangsu~     province in China. Two groups were generated based on the adjunctive rhIL-2 therapy during 24~     months regiman. Bacteriological and imaging data were followed during 24 months with cure~     rates analysed.~   "
37979|NCT03069521|"~     Prospective, feasibility study to evaluate the safety of the EndoArt™ for treatment of 12~     subjects suffering from corneal edema. Followed up for 12 months.~   "
37980|NCT03069508|"~     This study is a phase IIa open label pilot study of up to six months treatment with clemizole~     hydrochloride (200 mg vs. 300 mg vs. 400 vs. 500 mg mg) given orally TID to subjects with~     hepatocellular carcinoma that are either awaiting transplantation or have an unresectable~     lesion.~   "
37981|NCT03069495|"~     This study evaluates blood type 2 innate lymphoid cells in participants with mild to moderate~     asthma and participants with chronic urticaria as compared to healthy adult participants.~   "
37982|NCT03069482|"~     Quitting smoking has important health benefits for people with serious mental illness, more~     than half of whom are smokers. Smoking reductions in this population, in turn, could~     contribute to saving billions of dollars in healthcare expenditures.~      Finding ways to deliver more effective and wider reaching smoking cessation interventions to~     individuals with serious mental illness is a pressing priority. Smartphone apps are a wide~     reaching technology that could provide a viable platform to deliver smoking cessation~     interventions for individuals with serious mental illness.~      However, do smoking cessation apps need to be tailored for people with serious mental illness~     to ensure their success? Or can providers simply use standard and freely available smoking~     cessation mobile health treatments designed for the general population? Furthermore, is it~     feasible to conduct mHealth trials in this population?~      Therefore, this trial will test whether (1) a tailored smoking cessation app for people with~     serious mental illness results in higher levels of engagement with smoking cessation content~     as compared to an app designed for the general population and (2) smoking cessation mHealth~     trials can be feasibly conducted in this population.~   "
37983|NCT03069469|"~     This is a multicenter, open-label Phase 1 study of DCC-3014 in patients with advanced~     malignancies, featuring solid tumors, but will also enroll select patients with acute myeloid~     leukemia (AML), myelodysplastic syndrome (MDS), acute lymphocytic leukemia (ALL), or chronic~     lymphocytic leukemia (CLL). There will be an Escalation Phase and an Expansion Phase in this~     study~   "
37984|NCT03069456|"~     The investigators want to compare the performance of anesthetic depth monitoring for sedation~     (ADMS) to the bispectral index (BIS) as electroencephalographic measures of sevoflurane~     effect using two combined sigmoidal Emax models via population pharmacodynamic approach.~   "
37985|NCT03069443|"~     This Study evaluates the effect of 20 weeks of isometric handgrip (IHG) home training in~     adults aged 50 years or more. Half of the participants will serve as a control group and will~     only receive hypertension-guidelines on lifestyle changes.~   "
37986|NCT03069430|"~     This study is being conducted to test an intervention for children and adolescents ages 8-17~     years with sickle cell disease and their families. In the first phase of this study, key~     informant interviews are being conducted with health care providers and children ages 8-17~     with sickle cell disease and their primary caregivers. Participants are asked to review the~     intervention and provide feedback that will inform revision to the intervention.~   "
37987|NCT03069417|"~     The main aim is to conduct a pilot field test of a group-based depression and adherence~     counseling intervention with HIV-infected women in the perinatal period. Participants will be~     HIV-infected women living in KwaZulu-Natal, South Africa.~   "
37988|NCT03069404|"~     The investigation is a multi-year observational study following the completion of the~     open-label, single dose Phase I/II study involving transplantation of allogeneic HuCNS-SC~     cells into 12 subjects with thoracic spinal cord injury.~      Subjects will be monitored at routine intervals for safety and preliminary efficacy for 5~     years post-transplantation of the Phase I/II investigation CL-N02-SC.~   "
37989|NCT03069391|"~     This study is intended to clarify the benefits to brain health and thinking processes that~     result from different forms of exercise. In particular, this study will investigate the~     possible benefits of physical exercise (such as pedaling an under-table stationary~     elliptical) or mental exercise (such as playing a videogame on a portable tablet), or~     combining these activities together (as in the iPACES™ exergame).~   "
37990|NCT03069378|"~     The purpose of this study is to determine how well the combination of therapy of talimogene~     laherparepvec (T-VEC) and pembrolizumab works in the treatment of patients with sarcoma.~   "
37991|NCT03069365|"~     This Phase 3b, open-label, non-randomized study will evaluate the efficacy and safety of~     Glecaprevir/Pibrentasvir (GLE/PIB) for 8, 12, or 16 weeks in in participants with chronic~     hepatitis C virus (HCV) genotype (GT) 1 - 6 infection with or without compensated liver~     cirrhosis and with chronic renal impairment in both HCV treatment-naïve and prior~     treatment-experienced participants.~   "
37992|NCT03069352|"~     Acute Myeloid Leukaemia (AML) is an aggressive and rare cancer of myeloid cells (a white~     blood cell responsible for fighting infections). Successful treatment of AML is dependent on~     what subtype of AML the patient has, and the age of the patient when diagnosed.~      Venetoclax is an experimental drug that kills cancer cells by blocking a protein (part of a~     cell) that allows cancer cells to stay alive. This study is designed to see if adding~     venetoclax to cytarabine works better than cytarabine on its own.~      This is a Phase 3, randomized, double-blind (treatment unknown to patients and doctors),~     placebo-controlled, multicenter study in patients with AML who are 18 or more years old and~     have not been treated before. Patients who take part in this study should not be suitable for~     intensive induction chemotherapy (usual starting treatment). Abbvie is funding this study~     which will take place at approximately 125 hospitals globally and enrol approximately 175~     patients. In this study, 2/3 of patients will receive venetoclax every day with cytarabine~     and the remaining 1/3 will receive placebo (dummy) tablets with azacitidine.~      Patients will continue to have study visits and receive treatment for as long as they are~     having a clinical benefit. The effect of the treatment on AML will be checked by taking~     blood, bone marrow, scans, measuring side effects and by completing health questionnaires.~     Blood and bone marrow tests will be completed to see why some people respond better than~     others. Additional blood tests will be completed for genetic factors and to see how long the~     drug remains in the body.~   "
37993|NCT03069339|"~     Study Design: Open labeled randomized controlled trial. The study will be conducted on~     patients attending outpatient or admitted to admitted to Department of Hepatology from~     January 2017 to December 2018 at ILBS, New Delhi~   "
37994|NCT03069326|"~     The purpose of this study is to test any good and bad effects of the study drugs called~     ruxolitinib and thalidomide. Ruxolitinib and thalidomide could shrink the cancer, but it~     could also cause side effects.~   "
37995|NCT03069313|"~     Significant Aromatase Inhibitor-associated toxicity, affects as many as 50% of patients with~     breast cancer leading to early discontinuation of this life-saving cancer treatment. No~     effective pharmacologic therapy has yet been identified for management of these symptoms, as~     many patients do not experience relief of symptoms with analgesic therapy. Vitamin B12,~     whether as injection or oral forms, has been used as a naturopathic product to provide relief~     for joint pain caused by arthritis. This effect has not been studied in the setting of~     Aromatase Inhibitor-Associated Musculoskeletal Symptoms (AIMSS).~   "
37996|NCT03069300|"~     Recent data have suggested that monocyte oxidative burst defect is associated with the~     development of infection in patients with severe alcoholic hepatitis. One report found~     reduced 28 day mortality in patients treated with N-acetylcysteine combined with prednisolone~     when compared to prednisolone alone. The current study seeks to reveal whether the mechanism~     by which NAC reduces susceptibility to infection is through improvement of phagocyte~     oxidative burst.~   "
37997|NCT03069287|"~     The aim of this study is to assess the effects of integrating family caregiver support into~     cancer clinical trials on the well-being of the caregiver, the care-recipient and on the~     cancer clinical trial system.~   "
37998|NCT03069274|"~     The prevalence of overweight and obesity in children have increased in recent years and this~     has been associated with replacing plain water intake by sugar-sweetened beverages.~      Because of this, the objective of the present study was to evaluate the impact of a~     school-based intervention that aimed to replace sugar-sweetened beverages by water.~      A randomized community trial including 314 children aged 9-11 years from three public schools~     of the State of Hidalgo, Mexico was performed. Schools were randomized to intervention (two~     schools from municipality of Apan; six classes with 146 participants) or control group (one~     school from municipality of Emiliano Zapata; six classes with 168 participants) and followed~     during 6 months. Intervention included to place water filters at school and classroom lessons~     to increase water consumption and decreasing sugar-sweetened beverages.~   "
37999|NCT03069261|"~     The purpose of this study is to identify and compare complication rates between autologous~     breast reconstruction techniques with and without the inclusion on intraoperative indocyanine~     green (ICG) angiography.~   "
38000|NCT03069248|"~     This is a non-comparative, prospective, non-randomized single centre phase II clinical trial~     of Rituximab and alpha interferon immunotherapy following autologous stem cell transplant in~     patients with relapsed follicular lymphoma conducted at Toronto Sunnybrook Regional Cancer~     Centre/Sunnybrook and Women's Health Sciences Centre.~   "
38001|NCT03069235|"~     This study evaluates strategies aimed at promoting exclusive breast feeding for 6 months~     followed by continued breastfeeding for the next 6 months with introduction of complementary~     foods among HIV infected women in a resource limited setting.~   "
38002|NCT03069222|"~     This study will apply novel magnetic resonance imaging (MRI) techniques to investigation of~     spinal cord injury (SCI) to learn how nerve fibers repair and neural cells regain ability to~     control muscle during the rehabilitation. The information gained will be helpful for~     physicians to make more accurate diagnosis of SCI, predict injury recovery and movement~     restoration, and develop more effective treatment plans.~   "
38003|NCT03069209|"~     This is an open label, single arm, single center investigation to assess the safety and~     efficacy of purified adult autologous bone marrow derived specific populations of stem cells~     and mesenchymal stem cells injected into the ovaries (intraovarian injection), through a 12~     week follow-up period. The investigators' chosen model of study is based on increasing the~     efficiency of the approach by choosing an autologous model which preserves the genetic~     composition of an individual that is vital in infertility conditions. Additionally the~     approach involves transplanting a combination of specific purified stem cell types which all~     aid in ovarian function recovery.~   "
38064|NCT03068416|"~     Treatment of patients with B cell lymphoma or leukemia with two doses of CD19-targeting~     chimeric antigen receptor (CAR) T cells to evaluate for safety and efficacy.~   "
38251|NCT03065972|"~     This will be a prospective, single institution, parallel-group, single-blinded,~     randomized-controlled, two-arm, effectiveness study comparing autologous arteriovenous~     fistula versus hemodialysis access grafts in the elderly. The target sample size will include~     enrollment of 270 patients over a period of 5 years. The creation of an autologous~     arteriovenous fistula or placement of a hemodialysis access graft constitutes the two arms of~     the study.~   "
38004|NCT03069196|"~     Due to early diagnosis (<20yrs of age) of Type 1 Diabetes, patients face longer duration of~     disease and greater glycemic exposure which makes them more vulnerable towards chronic~     complications. The aim of this study is to investigate the prevalence and incidence of micro~     and macro-vascular, pulmonary complications and patterns of growth failure in approximately~     500 Type 1 Diabetes patients enrolled at Diabetes Unit, King Edward Memorial Hospital~     Research Centre. Then follow up of 100 participants who are above 15 years of age at baseline~     will be done after 2 years to document incidence and progression of complications. This will~     contribute in assessing the public health burden of complications of Type 1 Diabetes.~      Factors associated with prevalence of complications will be investigated. This risk factor~     analysis could aid in further modifying current prevention and treatment recommendations of~     these complications. Results of this study could modify current clinical practice.~   "
38005|NCT03069183|"~     Total hip replacement (THR) is a common and major surgical procedure performed in elderly~     patients with significant comorbidities. Optimizing a patient's anesthetic and analgesic~     modalities could play a significant role in minimizing the risk of adverse events in the~     perioperative period and potentially shorten time to discharge and recovery.~      Establishing a safe and effective post-operative analgesic plan is of central importance to~     successful THR anesthesia care. The application of ultrasound visualization has improved the~     efficacy of the fascia iliaca compartment block (FICB). However, ultrasound-guided~     suprainguinal FICB has not yet been evaluated clinically in a large trial as a method of~     providing post-operative analgesia following THR.~      The investigators hypothesize that by performing the suprainguinal fascia iliaca block with~     ultrasound, it will be possible to achieve superior and more reliable analgesia in the first~     24 hours than without a block.~   "
38006|NCT03069170|"~     Until now, there is no effective approach to stop the progression of multiple sclerosis and~     stimulate re-myelination. Autologous stem cell transplantation shows hope and is quickly~     developing as an alternative therapy. We propose the use of autologous bone marrow-derived~     specific stem cell populations and mesenchymal stem cell transplantation (BM-MSC) associated~     with immuno-modulation to treat patients with relapsing-remitting MS (RRMS).~   "
38007|NCT03069157|"~     Atelectasis is a side effect of general anesthesia which can be found in all types of~     interventions and patients of all ages.1-3 The reported incidence of anesthesia- induced~     atelectasis in children varies, ranging from 12 to 42% in sedated and nonintubated patients~     5, 6 and from 68 to 100% in children with general anesthesia with tracheal intubation or~     laryngeal mask.~      The aim of this work is to evaluate the effect of lung recruitment on anesthesia induced~     atelectasis using intraoperative lung ultrasound.~      Objectives~        -  To determine the effect of recruitment on anesthesia induced atelectasis using lung~          ultrasound.~        -  To Estimate the change of Pao2 with anesthesia induced lung atelectasis.~        -  To Estimate the change of Pao2 with lung recruitment.~        -  To evaluate the feasibility of use of lung ultrasound as a tool to guide optimum lung~          recruitment.~   "
38008|NCT03069144|"~     Psoriasis, the most prevalent autoimmune disease in the U.S., manifests with plaque type~     psoriasis vulgaris with lesions localized to the scalp, postauricular region, face, diaper~     area, elbows, and knees. Inadequately controlled disease is common and a significant cause of~     extensive psychological and clinical morbidity in children. In addition, the safety and~     tolerability issues of common treatments for psoriasis including topical corticosteroids,~     calcipotriol, oral cytotoxic drugs, and biologic agents are especially problematic in~     patients that limit their use. Identification of therapies with high efficacy and safety~     profiles suitable for patients with psoriasis is therefore an area of critical unmet need.~     Haus Bioceuticals has developed a topical treatment for psoriasis denoted HAT1 (based on~     ingredients that have established clinical benefit), and further have demonstrated that HAT1~     is safe and profoundly effective in the treatment of psoriasis. This study is aimed to~     further evaluate the efficacy and safety of HAT1 compared to commonly used calcipotriol in~     patients with mild to moderate chronic plaque psoriasis.~   "
38009|NCT03069131|"~     We wish to perform a multicenter, double-blind RCT with two parallel-group stratified on the~     center, comparing rifaximin to no rifaximin (placebo) for the primary prophylaxis of SBP in~     'severe' cirrhotic patients with large ascites. The primary outcome will be the 12-month~     survival.~   "
38010|NCT03069118|"~     Individuals indicating risky substance use are randomly assigned either to a three-month~     online intervention on the Workit Health platform or a waitlist/treatment as usual. Those~     randomized to treatment will report reduced consumption of alcohol and other drugs and higher~     quality of life at study conclusion.~   "
38011|NCT03069105|"~     This study will look at caregiver burden and the coping behavior of caregivers of patients~     with cancer. Through this study, the investigators will identify the relationship between~     cognitive dysfunction (measured as a proxy rating by the caregiver), resilience, social~     support, cognitive appraisal, coping behavior, and caregiver burden, anxiety, and depression~     among family caregivers of patients with cancer.~   "
38012|NCT03069092|"~     As the leading cause of death, cardiovascular disease (CVD) accounts for about one-third of~     U.S. mortality. Physical inactivity, one of the main CVD risk factors, causes 6% of coronary~     heart disease worldwide. The American Heart Association has identified cardiovascular health~     behaviors including smoking, obesity, diet, and aerobic exercise; however, resistance~     exercise was not included due to the limited evidence of its efficacy. Comparatively, the~     cardiovascular benefits of aerobic training have been well-documented whereas the independent~     and additive benefits of resistance training on cardiovascular health have not been~     established. Thus, this project is aimed to answer one of the most common questions about~     exercise and health:What type or combination of exercise is most effective for CVD~     prevention? This project will significantly contribute to developing more effective CVD~     prevention approaches, advancing more comprehensive physical activity guidelines, and~     providing important insights and novel opportunities for the future science of physical~     activity and health.~   "
38252|NCT03065959|"~     The purpose of this study is to investigate the effect of CK-2127107 versus placebo on~     skeletal muscle fatigue assessed as change from baseline versus 14 days of treatment in sum~     of peak torque during isokinetic knee extensions.~      This study will also assess the effects of CK-2127107 on physical performance via a short~     physical performance battery (SPPB), stair-climb test and 6 minute walk test.~   "
38013|NCT03069079|"~     Title: Investigation of neutrophil defects associated with periodontal disease and tooth loss~     in children. A clinical study.~      Objectives: The primary objective of this study is:~        -  To investigate presence of periodontal disease and response to periodontal treatment in~          children affected by neutrophil defects~      The secondary objectives of this study are:~        -  To investigate presence of other dental diseases in children affected by neutrophil~          defects~        -  To assess oral microbiological and inflammatory parameters in children affected by~          neutrophil defects~      Primary outcomes: The primary outcomes are (a) presence of periodontal disease as assessed by~     clinical factors: probing pocket depth, attachment level, bleeding on probing and~     radiographic bone loss) (b) microbiological and host response factors: detected in~     periodontal pockets and gingival crevicular fluid and (c) response to treatment~      Study sample: Children affected by neutrophil defects and meeting outlined inclusion and~     exclusion criteria~      Number of participants: 50 children~      Study design: This is a longitudinal treatment study. All participants will attend for 4-7~     visits during the study as outlined below:~        -  Screening visit (visit 1): consent procedure, dental examination, saliva and plaque~          sampling~        -  Baseline visit (visit 2):, detailed periodontal examination, dental radiographs,~          sampling of gingival crevicular fluid and, if appropriate scaling, polishing and oral~          hygiene instructions~        -  Non-surgical periodontal treatment (visit 3A to 3D, max 4 sessions): oral hygiene~          instructions and supra- and sub-gingival debridement (under local anaesthesia if~          necessary)~        -  Follow-up Visit (visit 4, 4th to 7th visit) (six months following treatment): detailed~          dental examination, oral hygiene instructions, sampling of saliva, subgingival plaque~          and gingival crevicular fluid, tooth scaling and polishing.~   "
38014|NCT03069066|"~     Treatment of patients with in-stent restenosis (ISR) remains a challenge. This study will~     assess the efficacy of Bioresorbable Vascular Scaffolds (BVS) (Abbott Vascular) in the~     treatment of patients suffering from ISR after scoring balloon pre-dilatation.~   "
38015|NCT03069053|"~     Objectives- to find out whether a correlation exists between denudation of urothelium and~     diagnosic delay in patients with BPS / IC, secondary aim was to search a correlation between~     impact of symptoms evaluated with ICSI-ICPI and number of comorbid conditions associated with~     BPS-IC.~      Patients and Methods- Fifty-seven consecutive patients underwent cystoscopy under anaesthesia~     to classify those cases suspected of BPS/IC. As for the evaluation of the ICSI-ICPI scores we~     considered significant relevant values those ≥ 12. Patients underwent cystoscopy with~     hydrodistension under general (90%) or locoregional anaesthesia. Bladder biopsies were taken,~     including detrusor muscle, from those areas with the most apparent bladder wall lesions. All~     biopsies were then fixed in 4% formalin and sent to the Pathologist for examination.~   "
38016|NCT03069040|"~     Cervical cancer in young patients increased significantly in recent years, and early surgical~     treatment for patients with 5 years of survival rate is as high as 90%, But the traditional~     extensive hysterectomy (RH) caused by intraoperative pelvic autonomic nerve may damage the~     bladder and rectum and the incidence of complications such as sexual dysfunction is nearly~     25% to 80%, thus seriously affect the patient's quality of life.Pelvic autonomic nerve~     preservation system of extensive hysterectomy (NSRH) can decrease the complications of above,~     but at home and abroad mainly adopts pulling the urine tube time, determination methods of~     residual urine volume, bladder function are studied in only a few scholars urine flow~     mechanics method is applied to carry on objective appraisal limited cases of postoperative~     bladder function, and the anorectal function damage ，we can use the anorectal dynamics to get~     objective index of anorectal function .overall research lack of large sample research of~     dynamic system. No objective index to evaluate the anorectal function In the early stage of~     the study, we have conducted about uterine ligament, sacral ligaments and nerve distribution~     of the bladder cervix vaginal ligament of experimental research, provide the neural anatomy~     basis for NSRH operation, and based on research for innovative operation scheme is put~     forward.Proposed on the basis of the above research, this study adopt the internationally~     used - urine flow mechanics, the method for evaluating the bladder function of NSRH, RH, two~     kinds of the injured function of bladder surgery patients before and after operation of~     comparative study, the change of dynamic assessment before and after surgery in patients with~     bladder function,and the anorectal function dameage and than provide the basis for further~     treatment.~   "
38017|NCT03069027|"~     Emergence agitation following general anaesthesia may lead to serious complications like~     self-extubation or removal of catheters, which can lead to hypoxia, aspiration pneumonia,~     bleeding or reoperation. Nose surgery is associated with a higher incidence of emergence~     agitation. The investigators planned to evaluate the efficacy of external nasal nerve block~     in prevention of postoperative agitation following external nasal surgeries under general~     anesthesia(GA).~   "
38018|NCT03069014|"~     The purpose of this study is to determine the safety of 2 doses of LM11A-31-BHS in 180~     patients with Alzheimer's Disease versus placebo and to access biomarker and clinical~     exploratory endpoints of LM11A-31-BHS~   "
38019|NCT03069001|"~     This prospective study was conducted at Ain Shams University Hospital, Internal Medicine,~     Hepatology and Gastroenterology Department, and Tropical Medicine Department.~      To compare the efficacy of the combination of sofosbuvir and simeprevir for 12 weeks with the~     combination of sofosbuvir and ribavirin for 24 weeks in Egyptian patients with HCV-related~     Child A cirrhosis.~   "
38020|NCT03068988|"~     The prospective randomized clinical study investigating the effect of mesenchymal stem cells~     on tendon healing. The objective of the study is to demonstrate the effect of concentrated~     bone marrow stem cells ( MSCs ) to the healing of sutured tendon of the supraspinatus muscle~     in comparison to the same procedure performed without MSCs. We have postulated the hypothesis~     that MSCs enhance the healing of the sutured supraspinatus tendon to its humeral footprint.~   "
38021|NCT03068975|"~     To evaluate the efficacy and safety of Alvimopan(12 mg) in recovery of bowel function in an~     emergency trauma setting without the pre-operative dosage in patients that will receive~     abdominal surgery.~   "
38022|NCT03068962|"~     Dietary nitrate have been shown to have health benefits including lowering blood pressure~     (Hobbs et al, 2012), improving endothelial function and inhibiting platelet aggregation in~     healthy humans (Lidder & Webb, 2013). The main sources of dietary nitrate in the human diet~     are vegetables such as beetroot. Nitrates are converted to nitrites then nitric oxide (NO),~     following their reduction by commensal oral bacteria and those residing in the~     gastrointestinal tract (Hord, Tang, & Bryan, 2009; Lidder & Webb, 2013). A recent study has~     shown following elimination of oral bacteria by the use of a chlorhexidine based antiseptic~     mouthwash, the conversion of nitrate to nitrite is prevented and this is accompanied by a~     statistically significant increase in blood pressure in normotensive subjects (Kapil et al.,~     2013). To date, very few studies have investigated the potential role of these oral bacteria~     in control of blood pressure and if there are any inter and intra-individual differences in~     bacterial composition.~   "
38023|NCT03068949|"~     This study will evaluate in detail the way that the immune system responds to three different~     kinds of flu shots that are licensed in the United States.~   "
38024|NCT03068936|"~     Nasopharyngeal carcinoma has high incidence in the southern China, especially in Guangdong~     Province. In the world, the standardized morbidity has reached 30/10 million in men while in~     women, about 13/10 million. At present, the incidence of nasopharyngeal carcinoma in China~     accounted for more than 80% of the world. The cancer-related deaths is in the eighth, which~     is a serious threat to our people's health and life. A recent multi-center phase II study of~     stage II nasopharyngeal carcinoma showed that: compared with Intensity Modulation~     Radiotherapy (IMRT) plus cisplatin, the 3 year local control rate, regional control rate,~     distant metastasis-free survival rate and disease-specific survival rate of IMRT were~     similar, but the side effects of radiotherapy alone group were lower.~      Based on the results of the phase II clinical study, the investigators designed this phase~     III clinical study, with the aim to compared the efficacy and toxicity of these two treatment~     programs. And finally to provide sufficient evidence for the treatment of stage II~     nasopharyngeal carcinoma.~   "
38025|NCT03068923|"~     'The TOP Study' is a prospective cohort study whose main objective is to develop better~     prognostic biomarkers and identify children at risk of adverse thrombotic outcomes very early~     in the course after an initial venous thromboembolic events (VTE). The study will compare~     biomarkers in children that develop poor VTE outcomes (such as recurrence, postthrombotic~     syndrome and post PE impairment ) after an initial VTE with those that do not develop such~     outcomes.~   "
38026|NCT03068910|"~     This study will address a hypothesis that, in late pubertal girls with hyperandrogenemia,~     androgens antagonize progesterone's ability to suppress waking LH pulse frequency. All~     participants will receive 4 doses of progesterone; half of participants will be pretreated~     with androgen receptor blockade (spironolactone, 50 mg twice daily), while the other half~     will be pretreated with placebo (twice daily).~   "
38027|NCT03068897|"~     This is a randomized study, based in emergency departments, in which the investigators~     determine the utility of adding various skeletal muscle relaxants to standard therapy, which~     consists of ibuprofen and an educational session. Patients will be enrolled at the time of an~     emergency visit and followed for three months to determine outcomes.~   "
38028|NCT03068884|"~     Behavioural or cognitive flexibility (BF) is an essential ability which allows an organism to~     adaptively change responses in accordance with feedback of results. In humans, this ability~     is disrupted among those who suffer a variety of neurological and psychiatric conditions~     including Parkinson's disease, schizophrenia, addiction, obsessive compulsive disorder and~     autism. Additionally, there is evidence of substantial individual differences in BF within~     the healthy population.~      Two known neurobiological mechanisms which relate to BF performance are variation in dopamine~     (DA) and serotonin (SE) function. One particular brain regions which has been heavily~     implicated in BF is the prefrontal cortex (PFC), with the dorsolateral PFC receiving a~     largely DA innervation and the dorsomedial PFC a SE input. Studies have demonstrated that~     damage to parts of PFC including the orbitofrontal cortex (OFC), for example, impairs~     reversal learning (a form of BF) whereas lesions of the dorsolateral PFC affect attentional~     set-shifting (another measure of BF).~      In humans, putative augmentation of DA efflux via administration of the DA and norepinephrine~     precursor tyrosine has been shown to improve task-switching performance, and inhibitory~     control suggesting a causal role of DA in regulating BF. Similarly, putative depletion of~     serotonin neurotransmission via tryptophan depletion procedures has been shown to reduce the~     BOLD response during performance monitoring and increase perseverative behaviour.~      One important strategy (in humans) to observe whether the PFC is causally involved in BF~     performance, is by reversible electrical stimulation of the PFC, so that PFC cells could be~     inhibited or excited while a participant is performing a BF task. In recent years, several~     laboratories have taken advantage of a relatively new technology known as transcranial direct~     current stimulation (tDCS) to study the relationship between brain function and behaviour.~     Using this technique, increases or decreases in cortical excitability are partly determined~     by the polarity of the stimulation; increases occur under the anode electrode whereas~     decreases occur under the negatively charged cathode.~      Using this approach, several studies have shown that anodal and cathodal stimulation over the~     PFC can have a number of effects on BF performance, with general improvements during anodal~     stimulation and impairments during cathodal. If this is the case, one important step that~     remains to be understood is whether dopamine and serotonin are causally related to these~     outcomes when neurons of the dLPFC/dMPFC are either excited or inhibited via tDCS.~      Thus, the specific novelty of this study rests in combining a psychopharmacological approach~     (i.e. tyrosine/tryptophan loading) with selective neuroanatomical (i.e.~     dorsolateral/dorsomedial prefrontal cortex) inhibition of cells via tDCS while participants~     are performing BF tasks. By doing so, we will be able to establish whether increased~     dopaminergic/serotonergic output to the PFC is a necessary requirement for BF performance.~   "
38029|NCT03068871|"~     participants will be randomized into one of three groups: 3-session CET intervention,~     3-session ACT intervention, or Waiting List group. Each weekly session will last up to 2~     hours and 10 participants will be assigned to each group. There will be two cohorts, with 30~     participants in each cohort. The Waiting List group will receive the CET intervention after~     the groups have completed theirs.~   "
38030|NCT03068858|"~     The SYNTAX score (SS) has been recommended by clinical guideline and appropriate use criteria~     for coronary revascularization (CR) to provide guidance on optimal treatment strategies for~     patients with stable coronary artery diseases (CAD). However, discrepancy in SS between~     angiographic core lab (ACL) and cardiologists has been found. Whether the misestimate will~     lead to inappropriate CR and whether a SS intervention will improve CR appropriateness in~     patients with stable CAD remain unknown.~      Thus, our study aims at evaluating whether a real-time feedback from ACL rightafter the~     angiographies will improve CR appropriateness. A before-and-after controlled trial was~     designed. In the first period of time, stable CAD patients undergoing elective coronary~     angiographies with at least one coronary lesion stenosis ≥ 50% from one Chinese cardiac~     center will be continuously recruited as the control group. In the second period, eligible~     patients will be recruited continuously and a real-time SS category feedback from ACL~     rightafter the angiography will be given to the cardiologists. Appropriateness of treatment~     strategies in two groups will be analyzed to determine whether a real-time SS feedback can~     improve the treatment appropriateness. The appropriateness of treatment strategies will be~     adjudicated by Chinese version appropriate use criteria for CR.~   "
38031|NCT03068845|"~     The purpose of this randomised clinical trial is to evaluate the efficacy of drug-eluting~     balloon compared to conventional balloon in balloon-assisted maturation of non-maturing~     arteriovenous fistula in adult renal failure patients.~   "
38032|NCT03068832|"~     The early clinical development paradigm for chemotherapeutic agents has significantly~     influenced the development of therapeutic cancer vaccines. However, there are major~     differences between these two classes of therapeutics that have important implications for~     early clinical development. Specifically, the phase 1 concept of dose escalation to find a~     maximum-tolerated dose does not apply to most therapeutic cancer vaccines. Most therapeutic~     cancer vaccines are associated with minimal toxicity at a range that is feasible to~     manufacture or administer, and there is little reason to believe that the maximum-tolerated~     dose is the most effective dose.~      In a recent article from the biostatistics literature, Simon et al. write that the initial~     clinical trial of many new vaccines will not be a toxicity or dose-ranging trial but rather~     will involve administration of a fixed dose of vaccine … in most cases the dose selected will~     be based on preclinical findings or practical considerations. Using several dose levels in~     the initial study to find the minimal active dose or to characterize the dose-activity~     relationship is generally not realistic.~      Consistent with these recommendations, the general philosophy of the phase 1 clinical trial~     is to facilitate a prompt preliminary evaluation of the safety and immunogenicity of the~     personalized synthetic long peptide vaccine strategy. The proposed clinical trial will test a~     fixed dose of vaccine. There is considerable experience with the synthetic long peptide~     vaccine platform. The synthetic long peptide vaccine platform has an excellent safety~     profile, and the optimal dose appears to be based on practical considerations (solubility of~     the peptide). The dose to be tested in the proposed clinical trial is consistent with other~     similar cancer vaccine trials that have been recently completed or are currently ongoing. The~     sample size (n=10-20) will provide a reasonably reliable estimate of the safety and~     immunogenicity of the vaccine.~   "
38033|NCT03068819|"~     Donor Lymphocyte Infusion (DLI) following salvage chemotherapy is the one of the most widely~     used treatment approaches in patients who relapse after allogeneic hematopoietic cell~     transplant (allo-HCT). However, the complete remission (CR) rates and long term survival~     remain very poor in these patients and, therefore, there is an unmet need to develop more~     effective treatment approaches in patients who relapse after allo-HCT.~      Based on the initial promising results with our ongoing cytokine-induced memory-like (CIML)~     natural killer (NK) cell trial, the investigators hypothesize that combining the CIML NK~     cells with DLI approach will significantly enhance the graft versus leukemia and therefore~     potentially provide potentially curative therapy for these patients with otherwise extremely~     poor prognosis. Combining CIML NK cells with the DLI platform will also potentially allow~     these adoptively transferred cells to persist for longer duration as they should not be~     rejected by donor T cells as the CIML NK cells are derived from the same donor. The use of~     CIML NK cells is unlikely to lead to excessive graft versus host disease (GVHD) as previous~     studies have not been associated with excessive GVHD rates.~   "
42268|NCT03013478|"~     To conduct an 8-week randomized trial evaluating the feasibility and efficacy of adding~     CBT4CBT to treatment as usual in a community based primary care program in a population of 60~     individuals who meet current DSM criteria for substance use disorder other than nicotine.~   "
38036|NCT03068780|"~     This is a Phase III, Efficacy and Safety Study of Oleogel-S10 in Participants with Inherited~     Epidermolysis Bullosa (EB).~      EB is a rare group of genetic skin fragility disorders characterised by blistering of the~     skin in response to minor injury. In most cases, onset of EB is at birth or shortly after.~     All participants affected by any type of EB share the main characteristic of repeatedly~     developing painful wounds that take days to months to heal. Current treatment of EB is~     primarily preventative and supportive including protection from mechanical forces by avoiding~     rubbing, early treatment of wounds to prevent infections, and protection of the wound with~     adequate non-adhesive dressings to enable healing.~      Oleogel-S10 was authorised in 2016 in the European Union for treatment of partial thickness~     wounds in adults under the brand name Episalvan®. The active pharmaceutical ingredient in~     Oleogel-S10 is a refined birch bark extract, quantified to 72 to 88% betulin.~      This clinical study of Oleogel-S10 in patients with inherited EB has been initiated to~     investigate whether Oleogel-S10 is effective for treatment of EB wounds and safe in the long~     term use.~      Oleogel-S10 will be compared to a vehicle gel placebo. The placebo is an identical looking~     sunflower oil gel that does not contain any active substance. The participant will receive~     either Oleogel-S10 or vehicle gel for a double-blind study phase of 90 days. The probability~     that the participant will receive Oleogel-S10 is 50%, which means that they have a 1 in 2~     chance of receiving Oleogel-S10. However, in the follow-up phase of the study all~     participants will be treated with Oleogel S10 for a period of 24 months.~      This clinical study will be performed in several countries; in total, about 164 participants~     are expected to participate.~   "
38037|NCT03068767|"~     300 HBV carriers with inadequate serum vitamin D levels were randomized to two groups: one is~     supplied with vitamin D and another without as controls. The markers of HBV replication were~     compared before and after treatment.~   "
38038|NCT03068754|"~     This is a multicenter, multiple dose study to examine the effect of H.P. Acthar® (Acthar) on~     functional decline in adult subjects with amyotrophic lateral sclerosis (ALS).~   "
38039|NCT03068741|"~     Sepsis occurs when a serious infection - most commonly infection of the lungs, urinary~     system, or blood - leads to acute organ failure. It is a common, expensive, and frequently~     lethal condition. A growing body of evidence suggests that early recognition and treatment of~     sepsis can improve survival.~      Unfortunately, many patients with sepsis do not receive key therapies until physicians~     working in Emergency Departments have assessed them - often introducing marked delays. It is~     estimated that one‐half of patients with sepsis are treated and transported to hospital by~     paramedics. This allows paramedics a unique opportunity to provide early treatment at the~     initial point of patient contact, thereby decreasing the time to treatment for these~     critically ill patients. This randomized controlled trial will evaluate whether prompt~     recognition followed by early antibiotics and/or intravenous fluids delivered by paramedics~     in the field leads to improved survival, compared to usual care, for patients who are~     transported to the hospital with sepsis.~   "
38040|NCT03068728|"~     This study is a prospective comparison between absorbable hemostatic agents as a group and~     the body's natural hemostatic ability without aid of therapy in patients undergoing bilateral~     sinus surgery with or without septoplasty.~   "
38041|NCT03068715|"~     This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial~     magnetic stimulation device for treatment-resistant depression. In a double-blind fashion,~     half the participants will receive accelerated theta-burst stimulation while half will~     receive sham treatment.~   "
38042|NCT03068702|"~     Sickle cell maculopathy was sparingly mentioned in the literature before despite the fact~     that sickle cell disease or sickle cell trait is common in people of many areas of the world.~     This study shows that OCTA is a very valuable, non invasive, office procedure that may well~     be used in diagnosing this disease.~   "
38043|NCT03068689|"~     Remote Ischaemic PreConditioning (RIPC) is performed prior to partial nephrectomy.~     Postoperative calprotectin dynamics and Blood Oxygen-Level-Dependent (BOLD) MRI are used to~     to demonstrate the potential renoprotective effect of RIPC~   "
38044|NCT03068676|"~     The current study is an open feasibility trial with the aim of providing a description of the~     factors associated with the implementation of an iCBT platform into an existing treatment~     framework in a primary care setting. The trial will examine the factors surrounding~     implementation, such as the experience of primary care practitioners and the online~     supporters, the recruitment process, and attitudes towards the overall implementation of the~     interventions. Patients presenting to the primary care setting will be screened using~     standard depression and anxiety measures, and where appropriate, will be referred to an iCBT~     intervention for either depression or anxiety, with support from trained staff. Analyses will~     be conducted on outcome measures to examine changes in symptom severity as patients progress~     through the intervention. Patient satisfaction data will also be collected to establish~     patient acceptability of the intervention. [Note: Recruitment is ONLY open to patients at~     Ohio Family Practice Center]~   "
38045|NCT03068663|"~     The subject is to study the lung microbiota and the one of upper airways (UAs) (much less~     studied than the intestinal microbiota) in 40 patients having lung cancer. 20 patients~     undergo only surgical treatment, while other half receives also chemotherapy. The idea is to~     explore changes in microbiota of the lung, upper UAs and intestine, and potentially find~     associations between them. These results will serve us as a base for the future study,~     focused on manipulation of the microbiota by prebiotics, probiotics or symbiotics and its~     effect on anti-cancer treatment tolerance and effectiveness.~   "
38046|NCT03068650|"~     Celldex endeavors to make investigational products available to patients with~     life-threatening diseases who have exhausted other treatment options and where there is a~     reasonable expectation of benefit over risk. Requests for expanded access to rindopepimut in~     patients with EGFRvlll expressing recurrent glioblastoma will be considered.~   "
38047|NCT03068637|"~     The overarching objective of this study is to evaluate the feasibility, usability, and~     acceptability of an abbreviated, tablet-based geriatric assessment in a population of older~     adults with multiple myeloma.~   "
38285|NCT03065530|"~     Nervous, anxiety, fear and other psychological reactions always appears in parturients during~     cesarean section. This study intends to investigate the effectiveness and safety of~     dexmedetomidine combined with butorphanol tartrate for postoperative analgesia and~     breastfeeding after caesarean section.~   "
38048|NCT03068624|"~     This clinical research study is divided into 2 parts: leukapheresis and treatment. In the~     leukapheresis part, white blood cells called T cells will be collected from you to be made~     into specialized CD8+T cells. To make specialized CD8+T cells, researchers separate out T~     cells from blood and treat them so they are able to target melanoma cells. The blood cells~     are then given back to the patient in the treatment part of the study. This is known as~     adoptive T cell transfer or adoptive T cell therapy.~      This consent form is for the treatment part of the study.~      The goal of this clinical research study is to learn about the safety of giving CD8+T cells~     with cyclophosphamide, and IL-2 (aldesleukin) to patients with uveal melanoma that is~     metastatic (has spread). Some participants will also receive ipilimumab. Researchers also~     want to learn if this combination can help to control the disease.~      This is an investigational study. Specialized CD8+T cells are not FDA approved or~     commercially available. They are currently being used for research purposes only.~     Cyclophosphamide, ipilimumab, and aldesleukin are FDA approved and commercially available for~     the treatment of uveal melanoma.~      Up to 30 participants will be enrolled in this study. All will take part at MD Anderson.~   "
38049|NCT03068611|"~     The overall objective of this project is to develop and pilot-test a web-based smoking~     cessation program that specifically addresses heavy drinking (HD). The project builds upon a~     well-established, free evidence-based smoking cessation website, BecomeAnEX.org (EX), which~     is supported by Truth Initiative, a national non-profit public health organization, and its~     research arm, the Schroeder Institute. Investigators will develop an alternative version of~     BecomenAnEX that will include detailed content on alcohol's relation to smoking relapse,~     health effects of alcohol (including moderate drinking recommendations) along with related~     worksheets, feedback materials, and links to resources for drinking. Once a version of~     BecomeAnEX is developed that specifically addresses HD (called EX-HD), the investigators will~     conduct a one-arm open pilot of the site with 30 HD smokers recruited from newly registered~     BecomeAnEX users. The study will gather participant feedback on the site as well as site use~     metrics (e.g., number of logins, number of pages viewed, use of interactive components) and~     will revise EX-HD in response to this feedback in preparation for Stage 1b work. Stage 1b~     will use the updated EX-HD version to run a small scale randomized clinical trial where 120~     participants will be randomly assigned to the standard version of BecomeAnEX or to EX-HD.~   "
38050|NCT03068598|"~     Promising results have shown that interventions to reduce insomnia diminish suicidal~     ideation. A better understanding of the bidirectional mechanism between sleep disturbances~     and suicide behavior will allow the design of tailored interventions to prevent suicide~     attempts.~      Significance of the proposed study for the field The aim of the present is to assess the~     feasibility and the acceptability of sleep tracking monitoring in a sample of suicide~     attempters. The investigator hypothesize that sleep monitoring using a connected object is~     feasable and acceptable by patients.~   "
38051|NCT03068585|"~     In 2010, we completed a phase 1 to 2a clinical trial of pCMV-vegf165 in patients with chronic~     lower limb ischemia (stage 2a to 3 according to Fontaine classification modified by A. V.~     Pokrovsky) who were not suitable for reconstructive surgery or endovascular treatment. This~     study demonstrated the safety, feasibility, and short-term(3 months) efficacy of pCMV-vegf165~     gene transfer,12,13which lead to conducting a phase 2b to 3 multicenter clinical trial. The~     study was conducted under the control of the Russian Ministry of Health and was completed in~     2011. Patients enrolled in the study were subjected to a 6-month~   "
38052|NCT03068572|"~     Linked color imaging(LCI),a new system for endoscopy modality,creates clear and bright~     endoscopic images by using short-wavelength narrow-band laser light combined with white laser~     light on the basis of magnifying blue laser imaging(BLI) technology.LCI makes red areas~     appear redder and white areas appear whiter.Thus,it is easier to recognize a slight~     difference in color of the mucosa.This is a study to assess the effectiveness of LCI for~     diagnosing esophageal minimal endoscopic lesions and Los Angeles classification system when~     compared to conventional white-light endoscopy (WLI).Gastroesophageal reflux disease(GERD) is~     a common disease that be defined as a condition which develops when the reflux of stomach~     contents cause troublesome symptoms and/or complications.Esophageal injury was classified~     according to the Los Angeles classification system,Non-erosive reflux disease(NERD) is~     defined by the presence of troublesome reflux-associated symptoms and the absence of mucosal~     breaks at endoscopy,which includes minimal change oesophagitis and no endoscopic~     abnormalities.LCI improved the visualization of the squamocolumnar junction (SCJ) by~     enhancing the contrast,mucosa minimal changes could be seen more easily and clearly with LCI~     than with standard white-light endoscopy.By comparing White-light endoscopy and LCI,it will~     show if there is any comparable advantage to using one or the other for lesion detection.~   "
38053|NCT03068559|"~     The aim of the present prospective study was to assess dysphagia (occurrence, severity,~     length) in head and neck cancer (HNC), from diagnosis to 18 months after their first line~     treatment regardless of the treatment. The investigators have complied with the pre-listed~     clusters.~      For this purpose, pursuant to consensus on the dysphagia assessment, the investigators used~     the Deglutition Handicap Index (DHI) questionnaire (Silbergleit 2012) for dysphagia screening~     and patient's self-perception. This was the only questionnaire validated in French evaluating~     the swallowing function by the patient (Woizard 2006).~      Clinical evaluation according to NCI-CTCAE v4.0 criteria and objective measures of swallowing~     function were also recorded and compared to DHI results.~   "
38071|NCT03068325|"~     This study seeks to examine feasibility, acceptability, safety, and preliminary efficacy of~     trauma-focused Equine-Assisted Therapy (EAT) for veterans with posttraumatic stress disorder~     (PTSD). While several well-studied, validated treatments for PTSD exist, some individuals~     find these treatments ill-suited, ineffective, or undesirable. EAT is an alternative therapy~     widely used by organizations, such as PATH International Equine Services, that endorse its~     effectiveness for treating a variety of mental health issues. These claims have drawn~     criticism because the published research contains glaring methodological flaws, making it~     difficult to assess how effective these therapies actually are (Anestis et al., 2014).~     Equine-assisted therapies present a unique treatment modality that might effectively treat~     PTSD, particularly for individuals who have difficulty with other treatment modalities. In~     EAT, a psychotherapist and equine specialist work together to help the patients negotiate~     interactions with a horse using structured interventions or activities.~   "
38054|NCT03068546|"~     Background:~      The human biome is the collection of microbial genes found in and on the body. It has been~     associated with many health conditions. But certain factors might affect the findings from~     microbiome studies. These include collection method, lab handling, and data processing.~     Researchers want to test the effect of long-term storage in a freezer on two oral sample~     collections methods. These methods are OMNIgene ORAL and Scope mouthwash.~      Objective:~      To test the effect of long-term freezing on the oral microbiome measured from OMNIgene ORAL~     and Scope mouthwash.~      Eligibility:~      Employees of the National Cancer Institute who:~        -  Are age 18 or older~        -  Have not used antibiotics in the past 3 months~      Design:~      Participants will have 6 visits within 2 weeks. At visit 1 they will complete a questionnaire~     about health and lifestyle. All visits last 15-30 minutes and include:~        -  1-2 saliva samples using OMNIgene ORAL: They will spit in a collector.~        -  1-2 Scope samples: They will gargle with Scope mouthwash and spit in a cup.~        -  Questions about how well they followed the preparation procedures~      Participants will follow preparation procedures: For 12 hours before each visit, they must~     not:~        -  Brush their teeth~        -  Floss~        -  Use mouthwash~        -  Eat or drink anything other than water~        -  Chew gum~        -  Consume throat lozenges or candies~        -  Smoke or chew tobacco~      Participants samples will be stored in a freezer. They will get data about their oral~     microbiome if they wish.~   "
38055|NCT03068533|"~     Dentinal hypersensitivity [DH] is a common condition in daily practice, especially in~     patients who have abrasion, attrition, gingival recession and erosion of teeth. It can affect~     individuals in the age range of 20-50 years.In a recent systematic review, it was reported~     that no gold standard treatment modality for dentin hypersensitivity has been established~     Thus there is a need to evaluate new formulations in different settings and in different~     populations and to compare those to commonly used agents seeking better results in pain~     relief for our patients. Studies showed that dentifrice formulations containing 8% arginine~     in combination with calcium carbonate and fluoride have the ability to plug dentinal tubules,~     by clumping of both arginine and calcium carbonate that bind with the negatively charged~     dentin . Aim of the study is to clinically evaluate toothpaste containing 8% arginine,~     calcium carbonate, and sodium mono-fluorophosphate, in comparison to toothpaste, containing~     8% strontium acetate and NaF on the relief of DH in chronic periodontitis patients.~   "
38056|NCT03068520|"~     PET-MRI scanning regarding amino acid metabolic profile, functional and morphological details~     will be performed on set intervals to patients with brain tumor & brain metastases in order~     to try to optimize the study protocol, distinguish between pseudo-response to anti-angiogenic~     therapy and tumor progression, and most importantly try to distinguish between progressive~     tumor and treatment related effects.3 cohort of patients will be included in the study.~   "
38057|NCT03068507|"~     The process of enhancing an individual's functional capacity to optimize physiologic reserves~     before an operation to withstand the stress of surgery has been coined prehabilitation. This~     is a prospective randomized controlled trail, designed to explore if the patients who take~     thoracoscopic lobectomy for lung cancer will benefit from family trimodal prehabilitation~     strategy. Trimodal prehabilitation includes exercise, nutrition supplement and physiology~     management preoperatively. It starts from the day that patients decide to take the surgery~     until the day before surgery, lasting 2~3 week in our hospital. And we follow-up patients~     until 8 weeks after surgery to investigate if trimodal prehabilitation strategy can improve~     the postoperative functional recovery，reduce complications and improve prognosis.~   "
38058|NCT03068494|"~     The COBIS III registry is a multi-center, real-world registry of 2nd generation drug-eluting~     stenting in coronary bifurcation lesions in South Korea. From 31 major coronary intervention~     centers in Korea, a total of 3,000 patients (anticipated) will be enrolled in this database~     between January 2010 and December 2014.~      The aim of the study was to investigate long-term clinical results and predictors of adverse~     outcomes after percutaneous coronary intervention with 2nd generation drug-eluting stents for~     coronary bifurcation lesions in South Korea.~   "
38059|NCT03068481|"~     The purpose of this study in healthy adult males is to investigate safety and~     pharmacokinetics of single and multiple oral doses of KDT-3594.~      The purpose of this study in patients with Parkinson's disease is to investigate safety and~     pharmacokinetics of single and multiple oral doses of KDT-3594. The exploratory efficacy of~     KDT-3594 will also be investigated.~   "
38060|NCT03068468|"~     The Primary objective of the study is to evaluate the efficacy of BIIB092, compared to~     placebo, as measured by a change from baseline in the PSP Rating Scale (PSPRS) at Week 52 and~     to assess the safety and tolerability of BIIB092, relative to placebo, by measuring the~     frequency of deaths, SAEs, AEs leading to discontinuation, and Grade 3 & 4 laboratory~     abnormalities.~      The Secondary objective of the study is to evaluate the efficacy of BIIB092, compared to~     placebo, as measured by a change in baseline in the Movement Disorder Society (MDS)-sponsored~     revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II at Week 52, to~     evaluate the efficacy of BIIB092, compared to placebo, as measured by the Clinical Global~     Impression of Change (CGI-C) at Week 52, to evaluate the efficacy of BIIB092, compared to~     placebo, as measured by a change in baseline in the Repeatable Battery for the Assessment of~     Neuropsychological Disease Severity (RBANS) at Week 52 and to assess the impact of BIIB092 on~     quality of life, relative to placebo, as measured by change from baseline on the Progressive~     Supranuclear Palsy Quality of Life scale (PSP-QoL) at Week 52.~   "
38061|NCT03068455|"~     The purpose of this study is to determine whether an investigational immunotherapy Nivolumab,~     when combined with Ipilimumab, is more effective than Nivolumab by itself, in delaying the~     return of cancer in patients who have had a complete surgical removal of stage IIIb/c/d or~     stage IV Melanoma~   "
38062|NCT03068442|"~     The invesigators propose a clinical study on patients undergoing carotid surgery~     (endarterectomy). The invesigators will determine carotid artery imaging features associated~     with (1) vessel wall inflammation, (2) downstream brain inflammation, and (3) cognitive~     benefit from surgery. This project will uncover links between inflamed carotid plaque and~     downstream brain inflammation. The invesigators will also determine carotid plaque imaging~     features predicting cognitive benefit from carotid surgery.~   "
38072|NCT03068312|"~     This study will evaluate the efficacy of ivacaftor treatment in subjects with CF 6 years of~     age and older who have a 3849 + 10KB C→T or D1152H CFTR mutation.~   "
38065|NCT03068403|"~     In recent years the concept of organ sparing treatment in rectal cancer was introduced for~     selected good responders after neo-adjuvant treatment. In these patients replacement of the~     standard of care total mesorectal excision (TME) by transanal endoscopic microsurgery (TEM)~     or omission of surgery after chemoradiation (CRT) was proposed. Before organ sparing~     treatments could be applied in clinical practice a reliable patient selection procedure has~     to be available as only good treatment responders after neo-adjuvant therapy are candidates~     for such adapted therapy. Different imaging modalities have been studied for their ability to~     distinguish good treatment responders from others. Examples of such imaging modalities with~     some promising results regarding response assessment are fludeoxyglucosepositron emission~     tomography (FDG-PET), T2-weighted magnetic resonance imaging (T2w-MRI), dynamic contrast~     enhanced magnetic resonance imaging and diffusion weighted MR imaging (DW-MRI). Besides these~     modalities dynamic contrast enhanced ultrasound (D-CEUS) is a new modality used for tissue~     characterization and therapy response assessment in several tumor locations, like liver~     tumors and breast cancer. D-CEUS reflect tissue vascular perfusion. For rectal cancer, the~     value of D-CEUS for pathological response prediction and assessment has never been assessed.~     Therefore, in this study we assessed D-CEUS to predict and assess pathological response in~     rectal cancer after neo-adjuvant CRT.~   "
38066|NCT03068390|"~     The investigators are testing a two-group, randomized, controlled trial with 280 primary~     caregivers of adult patients with a chronic illness to test the efficacy of the Rural~     Intervention for Caregivers' Heart Health (RICHH). Immediate (4-month) and long-term~     (12-month) effects of the RICHH intervention on CVD risk factors, self-management behaviors,~     and depressive symptoms will be compared to usual care. The investigators also will test the~     moderating effect of gender on intervention outcomes, given the many differences between male~     and female caregivers.~      Specific Aim 1: To determine effects of the RICHH intervention on the primary outcomes of CVD~     risk factors (i.e., lipid profile, body mass index, and blood pressure) at 4 and 12 months.~      Hypotheses 1: The intervention group will have better lipid profile, body mass index, and~     blood pressure outcomes than the usual care group at 4 and 12 months.~      Specific Aim 2: To determine effects of the RICHH intervention on self-management behaviors~     (i.e., diet quality, physical activity level, and self-report adherence to specific CVD~     health behaviors).~      Hypotheses 2: The intervention group will have better diet quality, higher physical activity~     levels, and better adherence to specific CVD health behaviors than the usual care group at 4~     and 12 months.~      Specific Aim 3: To determine effects of RICHH on depressive symptoms at 4 and 12 months.~      Hypotheses 3: Caregivers receiving the intervention will have lower levels of depressive~     symptoms than caregivers receiving usual care at 4 and 12 months.~      Specific Aim 4: To evaluate whether intervention effects on outcomes will differ by~     caregivers' gender.~      Hypotheses 4: Effects will be stronger for male compared to female caregivers at 4 and 12~     months.~      Impact: The proposed study will have a substantial impact on caregivers' cardiovascular~     health and quality of life because it will provide needed CVD risk prevention, and health~     promotion to rural caregivers living in distressed environments where CVD risk reduction and~     self-management is difficult. The intervention holds the potential to produce major~     improvements in health among caregivers living in rural environments in the US.~   "
38067|NCT03068377|"~     Objectives:To determine LYC-001e's influences on ocular blood flow Ocular blood flow has been~     implicated as a parameter relevant to eye health and involved in the disease process of~     several ophthalmic pathologies including AMD, glaucoma, and diabetes We hypothesis that~     LYC-001e will increase measures of ocular blood flow in healthy individuals~      Methods: This is a single-phase, randomized, parallel, double blind , comparative study of~     LYC-001e versus placebo on ocular blood vessels in healthy individuals.~   "
38068|NCT03068364|"~     Risk stratification of hypertensive patients includes assessment of traditional~     cardiovascular risk factors and subclinical target organ damages particularly left~     ventricular hypertrophy (LVH).~      LVH may routinely screened by transthoracic echocardiography by measuring the left~     ventricular mass (LVM).~      However, transthoracic echocardiography suffers from several pitfalls: poor reproducibility,~     technical limitations and unavailability at a first evaluation by general practitioners.~      Other biomarkers may be particularly helpful in hypertension risk stratification. The~     amplitude of the R wave in aVL lead is a simple validated ECG parameters of LVH and a strong~     predictor of cardiovascular events and mortality.~      Plasma N-terminal pro Brain Natriuretic Peptide (NT-proBNP) is also strongly related to LVM~     and is an independent predictor of all-cause mortality in hypertension.~      The main objective of our study is to determine the additive prognostic value of R wave in~     aVL and NT proBNP on all-cause and cardiovascular mortality.~      Secondary objectives are to determine the addition prognostic value of NT-proBNP and R wave~     in aVL combined in comparison to each marker taken into account~      This study will include 1600 patients who had a work-up of their hypertension in the~     Cardiology Department of Croix-Rousse Hospital (Hospices Civils de Lyon, Lyon, France) from~     January 1997 to January 2014.~      Their data will be collected in an Access database; their vital status will be obtained by~     the INSEE unit CépiDC.~   "
38069|NCT03068351|"~     This is a Phase Ib, open-label, multicenter, global study designed to assess the safety and~     tolerability of RO6870810 as monotherapy and in combination with daratumumab in participants~     with relapsed/refractory multiple myeloma. Each treatment cycle will be 21 days in length.~     There are two parts to this study. A dose-escalation phase (Part I) will be used to evaluate~     the safety and tolerability and dose limiting toxicities, and to establish the maximum~     tolerated dose/optimum biological dose of RO6870810 when given as monotherapy or in~     combination with daratumumab. A dose-expansion phase (Part II) will further characterize the~     safety, tolerability and activity of RO6870810 as monotherapy or in combination with~     daratumumab at the defined expansion dose-levels.~   "
38070|NCT03068338|"~     The research team's aim is to investigate the effects of the team's soft robotic socks in~     providing assisted ankle dorsiflexion-plantarflexion and promoting venous blood flow in~     stroke patients. Specifically, the investigators intend to 1) observe the development of~     joint contracture in terms of the range of motion of the ankle joint given the use of the~     device 2) monitor the presence of blood clots in the deep veins using compression Duplex~     ultrasonography given the use of the sock device.~      The investigators hypothesize that a soft robotics approach can provide compliant actuation~     to simulate natural ankle dorsiflexion and plantarflexion, which will consequently promote~     blood circulation in the lower leg of stroke patients who have not previously developed ankle~     joint contracture. This will prevent the occurrence of DVT and movement in the ankle joint~     will alleviate stiffness. This robotic sock intervention is to prevent the development of~     ankle joint contracture so established ankle contractures will be excluded from this study.~   "
38114|NCT03067766|"~     This pilot clinical trial studies how well comic art creation works as supportive care in~     cancer patients and caregivers. Participating in a comic art creation workshop may help~     patients and their family members or friends share their medical experience through~     storytelling and drawings in a way that can, but does not have to, reflect the real world. It~     may also help improve emotional wellbeing and communication in cancer patients and~     caregivers.~   "
38115|NCT03067753|"~     Monosialoganglioside Ganglioside in Cerebral Radiation Necrosis~   "
38302|NCT03065309|"~     This study will find the median effective dose of remifentanil for rapid sequence intubation~     which avoids bradycardia and hypotension~   "
38073|NCT03068299|"~     This research aims to analyze the effects of senior dance on the cognition, frailty, and~     burden in elderly caregivers of rural communities. This is a randomized clinical trial to be~     conducted with a sample of 58 elderly caregivers residing in rural communities. Data~     collection will be performed in the homes of the elderly and/or in the dependencies of the~     Family Health units (USFs - primary health care systems). They will answer Socio-demographic~     characterization instrument, ACE-R Battery, and electroencephalography for cognitive~     evaluation, five Fragility criteria proposed by Fried et al and Zarit Burden Inventory. The~     dance protocol will be applied to the experimental group (n=29) in the USFs and the control~     group (n=29) will receive health care, including guidance on health care and practices. The~     protocols include 24 interventions, 60 minutes each, weekly, during 6 months. Analysis of~     effects comparisons will be conducted between groups and be comparing baseline with final~     measurements. Dance intervention is expected to exert important positive effects on all study~     variables (cognitive performance, fragility assessment, and caregiver burden), compared to~     the group. The intervention of the control group is expected to exert positive effects on~     some variables of the study (mainly, caregiver burden).~   "
38074|NCT03068286|"~     SilverCloud provides internet-delivered interventions for depression and anxiety in NHS~     Mental Health Services. The interventions have proved successful in the management of~     depression and anxiety for clients presenting to mental health services, with recovery rates~     exceeding the national standard. Recently SilverCloud has embarked on tailoring the~     interventions for patients with long-term conditions including COPD, pain and diabetes. The~     purpose of the customisation is to make the interventions more meaningful and relevant to~     patients with LTCs, but all the while having the same goal of addressing depression and~     anxiety disorders. In doing so it would be expected that individuals might be in a better~     position to effectively self-manage their LTC. The current study, therefore, seeks to assess~     the possible effectiveness of implementing customised internet-delivered interventions for~     depression and anxiety for people with long-term conditions presenting to NHS mental health~     services.~   "
38075|NCT03068273|"~     This program will provide patients with type 1 and high risk type 2 diabetes the safest~     hospitalization by using wireless continuous glucose monitoring devices (CGM) to track their~     glucose parameters in real-time similar to other continuously monitored vital signs. The CGM~     will inform a team of health professionals who will monitor the patients' progress,~     communicate recommendations, and be available for discussion when recommended targets are not~     achieved. Health teams will utilize sensor results in addition to existing electronic medical~     records data to evaluate progress and manage care.~   "
38076|NCT03068260|"~     ECS is a very common procedure. A 1-year retrospective survey revealed a vast opioid~     consumption among the new mothers of approximately (mean±SD) 35±25 mg of oral morphine in the~     first 24 postoperative hours despite a multimodal analgesic regimen. The adverse effects of~     morphine are well known and include postoperative nausea and vomiting (PONV), itching,~     fatigue, constipation, confusion, respiratory depression and delayed mobilization. These~     adverse effects are unsound for the new mothers as well as the breast-fed, newborn children.~     This study aims to evaluate the efficacy of bilateral Transmuscular Quadratus Lumborum (TQL)~     block in reducing postoperative morphine consumption and pain.~   "
38077|NCT03068247|"~     The primary study intent is to examine biological mechanisms associated with acute and~     chronic treatment responses in major depressive disorder (MDD). It is hypothesized that~     treatment responsiveness, representing endogenous opioid system function, will be associated~     with acute improvements in mood state over a 10-week treatment trial in MDD. Potential (bio)~     markers of treatment effects will be tested against psychophysical responses to placebo and~     active treatments.~   "
38078|NCT03068234|"~     This study is to evaluate the efficacy and safety of an antifibrotic agent, pirfenidone as~     treatment of systemic sclerosis. The primary outcome of this study is improvement of skin~     fibrosis.~   "
38079|NCT03068221|"~     The Poly Cystic Ovary Syndrome (PCOS), is one of the most common reasons for subfertility,~     oligomenorrhea and amenorrhea. With the occurrence of 6-20% of the general adult women~     population. One of the main criteria of this syndrome is a hyper androgenic state.~      More than 50% of women who have PCOS are overweight. In the teenage population, PCOS is~     common in 5-10% of teenage girls. A recent research has shown that elite athlete teenage~     girls have higher serum androgen levels, especially in anaerobic types of sport.~      The purpose of this experiment is to examine the reaction of teenage PCOS overweight girls~     towards anaerobic exercise. To determine if their hyperandrogenic state is more adapted to~     excel in anaerobic exercise compared to teenage overweight girls without PCOS.~   "
38080|NCT03068208|"~     Efficacy of Methylene blue mediated Photodynamic therapy for primary localized cutaneous~     amyloidosis treatment in Asians, pilot study.~   "
38081|NCT03068195|"~     The purpose of this study is to determine whether microwave ablation is more effective in the~     treatment of simple renal cysts than conventional laparoscopic decortication.~   "
38082|NCT03068182|"~     Cardiovascular response to exercise affects the capacity of all body organs depending upon~     intensity, duration and mode of exercises. The aim was to compare acute effects of arm crank~     with treadmill moderate intensity exercises on heart rate variability in normal participants.~   "
38083|NCT03068169|"~     Cardiovascular diseases (CVD) are associated with high healthcare costs, as well as are a~     leading cause of mortality and hospitalizations. The main challenge for today's researchers~     is to develop new technologies, which may help to improve diagnosis of CVD, thereby reducing~     healthcare costs and quality of patients' lives. Non-invasive wearable electronics offer new~     capabilities for the diagnosis and management of patients with CVD. Several reports with~     wearable electronics have been published, in which achieved very positive results with high~     accuracy. Aim of our study is to show utility of biomedical shirt-based ECG monitoring of~     patients with CVD in different clinical situations using Nuubo® ECG (nECG) system.~   "
38084|NCT03068156|"~     Efficacy of 308-nm excimer laser for primary localized cutaneous amyloidosis treatment in~     Asians, pilot study.~   "
38125|NCT03067623|"~     The goal of this interventional study is to evaluate the increasing in endometrial thickening~     after the intrauterine infusion of 0,5-1 ml of autologous Platelet-Rich Plasma (PRP) and the~     implantation rate in women with thin endometrium undergoing Embryo-transfer, in order to~     propose a novel therapeutic approach for women with an endometrium < 7 mm unresponsive to~     standard treatments.~   "
38085|NCT03068143|"~     This prospective observational study is designed to investigate the relationship between~     brain temperature, axillary temperature, rectal temperature, and bladder temperature of~     postoperative patients with brain trauma, and the relationship between brain temperature and~     prognosis. This study is conducted based on the following important assumptions. First, brain~     temperature of postoperative patients with brain trauma should be higher than the axillary~     temperature, rectal temperature and bladder temperature. Second, the consistency of brain~     temperature and bladder temperature is better than the consistency of brain temperature and~     axillary temperature, as well as that of brain temperature and rectal temperature. Third,~     brain temperature can help clinicians to predict the prognosis of patients with brain trauma.~     Therefore, brain temperature monitoring is significant in postoperative intensive care and~     treatment of patients with brain trauma.~   "
38086|NCT03068130|"~     This extended access study will assess the long-term safety and tolerability of bardoxolone~     methyl in qualified patients with pulmonary hypertension (PH) who previously participated in~     controlled clinical studies with bardoxolone methyl.~   "
38087|NCT03068117|"~     Patients with malignant pleural mesothelioma (MPM) frequently have significant physical~     symptoms, with up to 92% of patients complaining of three or more symptoms at presentation.~     Such symptom scores are similar to those reported in advanced non small cell lung cancer~     (NSCLC) and have been demonstrated to correlate with interference with activity and worse~     quality of life (QOL). Several studies have reported that baseline Quality of Life (QOL) is a~     significant prognostic factor for survival in NSCLC patients. In 2010, a non-blinded~     randomised controlled trial of 151 patients in the United States (US) demonstrated an~     improved QOL, fewer depressive symptoms and improved survival with early, regular specialist~     palliative care team (SPCT) involvement in addition to their routine care.~      The RESPECT-Meso study will examine the effect on quality of life following early Specialist~     Palliative Care (SPC) involvement for Regular Early Symptom Control Treatment (RESSCT) in~     addition to routine care in patients with newly diagnosed MPM in the United Kingdom (UK).~   "
38088|NCT03068104|"~     This study aims to estimate the difference between predicted and provided massive transfusion~     in adult trauma patients admitted to university hospitals in urban India.~   "
38089|NCT03068091|"~     The purpose of this study is to determine whether patient with ILD have altered lung~     compliance on chest CT before they have macroscopic structural changes on CT.~   "
38090|NCT03068078|"~     Further studies are needed to establish the optimal diet for treating T2D.~      The investigators wishes to investigate whether a low carbohydrate diet, high in~     monounsaturated fats (LCD) will affect cardiovascular function, metabolism and the liver.~      135 participants with T2D, will be following either a LCD, or a regular diabetes diet (RDD)~     for 6 months. Measurements and investigations will be performed at baseline and after 6~     months.~   "
38091|NCT03068065|"~     This was a 24-week single-center, open-label, parallel controlled group comparing gliclazide,~     liraglutide, and metformin effects on diabetes with nonalcoholic fatty liver disease.~   "
38092|NCT03068052|"~     This is an RCT among UPHS employees between ages 50-64 comparing no incentive and a~     loss-framed incentive for completing cancer health risk assessment. Those eligible will~     receive the phone number for direct colonoscopy scheduling, with the incentive arm receiving~     an additional unconditional incentive. The primary outcome is completion of screening~     colonoscopy. Secondary outcomes include scheduling of colonoscopy and completion of risk~     assessment.~   "
38093|NCT03068039|"~     Breakfast porridges made from milled grains are commonly eaten worldwide. Traditionally~     different grains are used in different countries. For example, oats are more common in the~     Anglo-Saxon countries whilst millet is very common in parts of India and Africa. However the~     nutritional value of different grains and their potential effects on the body may vary~     dramatically: for example the effect on blood sugar, on how fast the stomach empties after~     eating and how full people may feel.~      RESEARCH QUESTION: The investigators think that a pearl millet breakfast will cause a smaller~     rise in blood sugar compared with an oat breakfast containing the same number of calories.~     The investigators also think that there will be a difference in how full people feel and how~     fast their stomach will empty. These 2 breakfasts will be fed to each one of 26 healthy~     volunteers, one week apart. A safe medical imaging method (MRI) will be used to look at how~     quickly the breakfast empty from the stomach and how this affects the small bowel. Blood~     glucose levels will be measured using a finger prick test (the same as used by diabetics) and~     some small blood samples will be taken from a vein in the arm to measure the chemicals~     released by the gut after feeding gut hormones.~   "
38094|NCT03068026|"~     People with COPD have more air in their lungs than other people (this problem with high lung~     volumes is called hyperinflation). Unfortunately this is unhelpful as breathing at higher~     lung volumes requires more effort and contributes to breathlessness. When anyone exercises,~     they breathe more quickly. People with COPD have narrowed airways, which makes breathing out~     difficult. When they breathe more quickly they may not be able to breathe out fully before~     they need to take the next breath in. This means that the volume of air in their lungs tends~     to increase further during exercise, which makes breathing even more difficult. This problem~     is called dynamic hyperinflation.~      Pulmonary rehabilitation is one of the most helpful interventions for people with COPD and~     most of the benefit gained is from exercise. Anything that helps people increase the amount~     of exercise they can perform should lead to further improvements.~      Non-invasive positive pressure ventilation is a method of supporting a person's normal~     breathing. The ventilator delivers a flow of air at low pressure as you breathe out, which~     helps patients to breathe out more completely. The device also detects when patients start to~     breathe in and delivers a stronger flow of air at a higher pressure, helping them to take a~     deeper breath in. Previous research studies have shown that when people with COPD use~     non-invasive ventilation during exercise they are able to exercise for longer and are less~     breathless. The purpose of this study is to assess whether a new portable non-invasive~     ventilation device, called the VitaBreath, helps people with COPD recover from breathlessness~     during the exercise breaks more quickly (by reducing dynamic hyperinflation, described~     above) and to exercise for longer overall. The VitaBreath device is small and light, weighing~     0.5 kilograms (just over one pound). It is handheld and battery powered.~   "
38126|NCT03067610|"~     Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either~     cisplatin, cetuximab, or carboplatin-paclitaxel)~   "
38127|NCT03067597|"~     To demonstrate the efficacy of controlled-release dinoprostone vaginal insert (DVI) for~     cervical ripening success (either Bishop Score (BS) ≥7 or vaginal delivery) within 12 hours~     of vaginal insert administration.~   "
38303|NCT03065296|"~     This project will encompass an evaluation of the educational value of having evidence based~     home exercise protocols available for family medicine residents in regard to the prescription~     of home exercise treatment for common musculoskeletal conditions. Investigators will be~     evaluating resident knowledge on home exercise prescription as well as their level of comfort~     in educating their patients before and after a series of didactic sessions and implementation~     of exercise protocols.~   "
38095|NCT03068013|"~     Background: Patients with advanced cancer suffer from a variety of psycho-social symptoms~     that impair quality of life and may benefit from psychotherapeutic treatment. We describe~     here the methodology of a randomized controlled trial to test the efficacy of a novel and~     brief semi-structured psychotherapeutic intervention, called Managing Cancer and Living~     Meaningfully (CALM), originally developed in Canada and now cross-culturally tested in Italy.~      Methods/Design: The study is a single-blinded randomized controlled trial with 2 conditions:~     CALM intervention versus nonspecific supportive intervention (SPI) and assessments at~     baseline, 3 and 6 months. The site is the Program on Psycho-Oncology and Psychiatry in~     Palliative Care, University of Ferrara and Integrated Department of Mental Health, S. Anna~     University Hospital, in Ferrara, Italy. Eligibility criteria include: ≥ 18 years of age;~     Italian fluency; no cognitive impairment; and diagnosis of advanced cancer. The intervention~     consists of 12 sessions , following the CALM manual and allowing for flexibility to meet~     individual patients' needs. It is delivered over a 3-6-month period and provides reflective~     space for patients (and their primary caregivers) to address 4 main domains: symptom~     management and communication with health care providers; changes in self and relations with~     close others; sense of meaning and purpose; and the future and mortality. The primary outcome~     is depression and the primary endpoint is at 3 months. Secondary outcomes include~     demoralization, generalized anxiety, death anxiety, spiritual well-being, quality of life,~     attachment security, posttraumatic growth, communication with partners, and satisfaction with~     clinical interactions.~      Discussion: This trial is being conducted to determine the feasibility and benefit of CALM in~     an Italian cancer setting. The intervention has potential cross-national relevance and, if~     shown to be effective, has the potential to be disseminated as a new approach in oncology to~     relieve distress and promote psychological well-being in patients with advanced cancer.~   "
38096|NCT03068000|"~     There will be a three-month intervention with two groups: judo training and ball games, twice~     a week, for 50 minutes. The sample will consist of children and adolescents with low~     socioeconomic status, participants of a philanthropic institution, aged between 6 and 15~     years, who will be randomized in the two groups mentioned above. Motor skills, physical~     fitness, cardiovascular parameters and questionnaire assessing socioeconomic status, quality~     of life, physical activity level, screen time, sleep quality, back pain, food intake and body~     image dissatisfaction will be evaluated.~   "
38097|NCT03067987|"~     Renova- Erectile Dysfunction (ED) is a Linear Shockwaves (LISW) device which incorporates a~     unique shockwave transducer operable to deliver shockwaves to a treated region. Shockwaves~     are aimed at the left and right corpora cavernosa and the crura. The study is aimed at~     determining the safety and effectiveness of this new type LISW in the relief of erectile~     dysfunction.~      HYPOTHESIS Alternate Hypothesis (HA): Active Treatment groups will show a >2-point increase~     in the IIEF-EF score from baseline for mild erectile dysfunction, and >5 points for moderate~     erectile dysfunction and will show significant change.~      Null Hypothesis (HO): There is no difference from baseline and after-treatment in Treatment~     groups for alleviating erectile dysfunction measured using International Index of Erectile~     Function score (IIEF-EF).~      Primary Efficacy Objective: To evaluate change of International Index of Erectile Function~     score Questionnaire score from baseline to follow-ups 1, 3 and 6 months' post treatment.~      Secondary Objectives:To study sexual activity improvement leading to optimal penetration at~     follow-ups according to:~        -  SEP- Sexual Encounter Profile Questionnaire.~        -  GAQ- Global Assessment Questionnaire.~        -  EHS- Erection Hardness Score.~   "
38098|NCT03067974|"~     The purpose of this study is to evaluate the feasibility of intranasal ketamine for adequate~     sedation of children undergoing minor procedures in the Emergency Department. An intranasal~     dose of 10mg/kg will be used in patients requiring procedural sedation. The investigators~     hypothesize that this dose of intranasal ketamine will be able to provide adequate sedation~     and analgesia for the physician to successfully complete the planned diagnostic or~     therapeutic intervention (Pediatr Emer Care 2012;28: 767-70). The primary endpoint will be~     successful sedation, as defined by the ability to complete the planned procedure without~     rescue medication, which includes re-dosing of the same medication.~   "
38099|NCT03067961|"~     Typhoid fever results from infection with a bacterium called Salmonella Typhi and is a major~     cause of illness worldwide. It is estimated to infect 20-25 million people every year and can~     affect people of all ages, but is particularly common in young children. The disease is~     spread through contaminated food and water, and efforts to improve water quality, sanitation~     and hygiene will likely go a long way to reducing the global burden of disease.~     Unfortunately, improving access to clean water and sanitation improvements is very costly and~     difficult to implement on a large scale. Vaccination against typhoid fever is likely to be a~     cost-effective way of reducing the global disease burden. There are two vaccines currently~     available against typhoid fever. Whilst these vaccines provide some protection against~     disease (in the region of 50-70%) these vaccines are less effective in young children, who~     are the population group at highest risk of disease. In order to develop a new generation of~     typhoid vaccines it is important to have a more complete understanding of how the bacterium~     causes disease. In this study, the investigators are aiming to understand more about the~     Salmonella Typhi bacteria and how it causes disease. In particular, the investigators aim to~     study the importance of a toxin produced by the typhoid bacteria, called the typhoid toxin.~     The typhoid toxin has only recently been discovered. It is made only by the typhoid bacteria~     and closely related bacteria, such as paratyphoid. From studies done in the laboratory, there~     is evidence that the typhoid toxin is important in causing typhoid disease. It is thought~     that the typhoid toxin might be important in causing symptoms of typhoid disease, however the~     exact role of the typhoid toxin during infection in humans hasn't been studied before.~     Studying this might impact on the design new vaccines against typhoid.~      In this study, the investigators will be undertaking a 'challenge' with two strains of the~     typhoid bacteria (Salmonella Typhi). This involves exposing participants to live Salmonella~     Typhi under defined circumstances, by asking them to swallow a solution that contains the~     bacteria. After the challenge the investigators closely monitor participants for a period of~     at least two weeks and the investigators will then treat participants with antibiotics as~     soon as they are diagnosed with typhoid disease. The investigators are interested in~     comparing the response to challenge between two strains of the typhoid bacteria that differ~     in the production of the typhoid toxin. This process has been undertaken by participants in~     previous Oxford Vaccine Group studies since 2011.~   "
38100|NCT03067948|"~     This research is a feasibility pilot of an intervention to respond to positive screening~     tests for mental health(MH) and substance use (SU) captured through the Patient Reported~     Outcomes questionnaires (PROs). The PROs are currently performed in the clinic, however, the~     results are neither reviewed with patients nor transmitted to providers. This pilot assesses~     the feasibility of moving the PROs into the clinical realm by having patients review the PRO~     results, identifying an issue to discuss at the patient's next HIV primary care visit, and~     determining whether this process increases discussion of MH and SU disorders in the~     subsequent clinical visit and/or increases referrals to MH and/or SU treatment.~   "
38101|NCT03067935|"~     Celldex endeavors to make investigational products available to patients with~     life-threatening diseases who have exhausted other treatment options and where there is a~     reasonable expectation of benefit over risk. Requests for expanded access to glembatumumab~     vedotin in patients with gpNMB expressing triple negative breast cancer will be considered.~   "
38151|NCT03067285|"~     A phase IV, multicentre, randomised, open-label, pilot clinical trial designed to evaluate~     HIV-infected, aviremic patients who receive treatment with the combination of DTG/3TC/ABC and~     who have neuropsychiatric adverse effects that, in the opinion of the investigators, may be~     related to taking DTG/3TC/ABC, if they improve after switching antiretroviral therapy to the~     combination of ELV/COBI/FTC/TAF.~   "
38102|NCT03067922|"~     Breast cancer is the most common cancer in women in India and accounts for 27% of all cancers~     in women. Incidence rises in early thirties, peaks at 50-64 years. Approximately 48% are~     below 50 years of age. Most present when symptoms develop, so are 2B and beyond. Treatment~     depends on the stage of the disease. Surgical removal of the tumour is part of the treatment~     attempting a cure.~      Simple mastectomy involves removal of breast tissue without axillary lymph node dissection or~     removal of chest wall muscles. Radical mastectomy involves removal of the entire breast,~     skin, pectoralis major and minor muscles and ipsilateral axillary lymph nodes. Modified~     radical mastectomy involves removal of the breast and ipsilateral axillary lymph nodes. The~     pectoralis muscle is preserved. Breast conserving surgery involves removal of tumour with or~     without axillary dissection. The extent of surgery tells us about the nerve damage, local~     tissue handling. For example operating in upper and outer quadrant of breast and axilla~     increases nerve handling in that particular region. Local radiation also plays a role.~      Persistent pain after mastectomy was first reported in the 1970s by Wood and defined by~     International Association for Study of Pain (IASP) as pain in the anterior aspect of the~     thorax, axilla, and/or upper half of the arm beginning after mastectomy or quadrantectomy and~     persisting for more than three months after surgery and known as Postmastectomy pain Syndrome~     (PMPS). It is a common problem, with a 25- 60% incidence. The pain is described as burning or~     tenderness with paroxysms of lancinating, shock-like pain, and also described by some as~     dysesthesia (perception of non noxious stimuli as painful). Risk factors for PMPS include~     age, raised Body mass index (BMI), severity of postoperative pain, type of surgery,~     susceptibility to pain with a history of other pains such as headache and dysmenorrhoea.~     Axillary hematoma and postoperative radiotherapy have also been implicated in the development~     of PMPS.~      Tata Memorial Hospital, is a tertiary cancer institute in India. Around 4000 patients with~     suspected breast cancers register annually at the hospital and approximately 2800 breast~     cancer surgeries are performed yearly. Very few studies on PMPS in Indian population exist.~     We therefore plan to identify the incidence of PMPS in our patients and also the severity of~     pain along with its impact on daily function and quality of life~   "
38103|NCT03067909|"~     Hundreds of thousands patients undergo implantation or replacement of cardiac implantable~     electronic devices (CIEDs) annually in Europe, and up to 50% of these subjects receive~     antiplatelet agents or oral anticoagulants. Antithrombotic therapy increases the risk of~     developing pocket hematoma which in turn is associated with an increased risk of potentially~     fatal device-related infections when clinically significant. Aim of the registry is to~     retrospectively (pilot local registry in Tuscany) and prospectively (multicenter national~     registry in Italy) investigate the different strategies for the management of antithrombotic~     therapy and the related complication rates (1-month and 12-months) in patients undergoing~     CIED surgery in a real-world setting. The registry will also provide data on the economic~     impact of different management strategies and complications.~   "
38104|NCT03067896|"~     Regional anesthesia has become more popular in cesarean deliveries because most of the~     parturients prefer being awake during the birth process. In addition, regional anesthesia may~     be a safer method than general. In spinal anesthesia local anesthetics alone may not be~     enough for an effective postoperative analgesia and hemodynamic stability of the patient wich~     is crucial during cesarean section. So far many adjuvants have been used to augment the~     analgesia produced by intrathecal local anesthetics and to reduce their adverse effects .~      Various intrathecal adjuvants to local anaesthetics have found to improve the quality and~     extend duration of spinal block. Prolongation of duration of spinal block is desirable both~     for long procedures and for postoperative pain relief. Efficacy and safty of intrathecal~     magnesium as analgesic adjuvant has been tested by several clinical trails in recent~     years.Antinociceptive effect of magnesium appears to be relevant for the management of~     chronic and post operative pain. These effects are primarily based on regulation of calcium~     influx in to the cell. Magnesium blocks calcium influx and non competitively antagonizes NMDA~     channels. NMDA receptor signelling plays an impartent in determining the duration of acute~     pain3).) addition of magnesium to spinal anaesthesia improved postoperative analgesia in~     orthopedic setting. addition of intrathecal magnesium sulfate to 10 mg bupivacaine plus 25µg~     fentanyl prolonged spinal anaesthesia in patients undergoing lower extremity surgery.~      Dexmedetomidine is a highly selective 2-adrenergic agonist which has been used as~     pre-medication and as an adjuvant to general anesthesia.Dexmedetomidine have several~     beneficial actions during perioperative period. They decrease sympathetic tone with~     attenuation of the neuroendocrine and haemodynamic response to anaesthesia and surgery,~     reduce anaesthetic and opiod requirement, cause sedation and analgesia. Dexmedetomidine was~     first introduced into clinical practice as a short term intravenous sedative in intensive~     care. Like any other adjuvant dexmedetomidine is not free from adverse effects. Use of~     dexmedetomidine is often associated with a decrease in heart rate and blood~     pressure.Dexmedetomidine was used to enhance the analgesic property of local anaesthetics~     like lidocaine bupivacaine and ropivacaine. In vivo and in vitro studies indicated that these~     local anaesthetics had significant neurotoxicity. Dexmedetomidine showed protective or growth~     promoting properties in tissues, including nerve cells from cortex. Intrathecal~     dexmedetomidine has a neuroprotective effect similar to methylprednisolone.~      The mechanism by which intrathecal alpha 2-adrenergic agonists prolong the motor and sensory~     block of local anesthetics is not clear. It may be an additive or synergistic effect~     secondary to the different mechanisms of action of local anesthetic and alpha 2 adrenergic~     agonist. The local anesthetics act by blocking sodium channels, whereas the alpha 2~     adrenergic agonist acts by binding to pre synapyic C fibre and post synaptic dorsal horn~     neurons. Intrathecal alpha 2 adrenergic agonist produce analgesia by depressing the realease~     of C fibre transmission by hyperpolarization of post synaptic dorsal horn neurons. Li et al~     observed that Glutamate is involved in excitatory neurotransmission nociception and plays an~     essential role in relaying noxious stimuli in the spinal cord. Intrathecal injection of alpha~     2 adrenergic agonists produces potent antinociceptive effects by altering spinal~     neurotransmitter release and effectively treats acute pain.~   "
38105|NCT03067883|"~     To evaluate efficacy and safety of Ombitasvir, paritaprevir, and ritonavir plus ribavirin~     based therapy for chronic hepatitis C with or without compensated cirrhosis in haemodialysis~     patients.~   "
38106|NCT03067870|"~     Rheumatoid arthritis is a chronic systemic disease, which is characterized by chronic~     inflammation in the synovial tissue. Rheumatoid arthritis ultimately results in the~     destruction of cartilage, bone and ligaments and joint deformity. The underlying hypothesis~     is that autologous bone marrow-derived mesenchymal and specific populations of stem cells has~     anti-inflammatory and regenerative effects and thus potentially alleviates the progression of~     rheumatoid arthritis. The study is to explore the safety and efficacy of BM-SC~     transplantation in treatment of rheumatoid arthritis.~   "
38107|NCT03067857|"~     Herein, the investigators study the safety and efficacy of transplanting purified autologous~     bone marrow-derived stem cells transplanted via the intrathecal route by interventional~     radiology and the intravenous route.~   "
38108|NCT03067844|"~     Coronary artery disease (CAD) is the most frequent cause of mortality in the industrialized~     world. Hypercholesterolemia is a major risk factor for the development and progression of~     CAD. While statins currently represent the first-line, gold-standard therapy for primary and~     secondary prevention of cardiovascular morbidity and mortality, nearly 50% of patients in~     Europe and Canada treated with statins do not achieve their target levels of low-density~     lipoprotein cholesterol (LDL-C) or cannot tolerate effective statin doses.~      Recently, a growing number of studies of PCSK9 inhibitors in a wide spectrum of patients with~     hyperlipidemia on or off lipid-lowering therapy, familial hypercholesterolemia, and statin~     intolerance demonstrated consistent, profound, and sustained reductions in LDL-C with greater~     magnitude of reduction as compared with high-dose statin regimens. However, the effects of~     PCSK9 inhibition on coronary plaque morphology remain unknown.~      This study will investigate the effect of the PCSK9 inhibitor alirocumab in patients with~     acute myocardial infarction undergoing percutaneous coronary intervention (PCI) in the~     infarct-related artery and receiving guideline-recommended high-intensity statin therapy. A~     serial, multivessel, intravascular ultrasound, near-infrared spectroscopy and optical~     coherence tomography imaging study will be performed to determine the change in plaque volume~     at week 52. A total of 220 patients will be enrolled in the study and randomized in a 1:1~     ratio to either alirocumab or placebo.~   "
38109|NCT03067831|"~     This study is single arm, single center trial to study the safety and efficacy of bone~     marrow-derived autologous specific populations of stem cells and mesenchymal stem cells for~     the treatment of Duchenne Muscular Dystrophy (DMD).~   "
38110|NCT03067818|"~     This study examines the effect of non-invasive brain stimulation targeting different brain~     areas on movement of the affected arm post-stroke. Participants will receive stimulation to~     each of 3 different brain areas combined with a session of arm exercise.~   "
38111|NCT03067805|"~     The aim is to evoke romantic jealousy between couples and investigate whether oxytocin has~     effect on it.~   "
38112|NCT03067792|"~     Patients diagnosis with inoperable gastric cancers are treated with palliative chemotherapy.~      Palliative chemotherapy had proven to be better overall survivals and quality of life in~     unresectable advanced gastric cancer. NCCN guideline suggested two or three drug cytotoxic~     regimen as a first line therapy. But response rate of those regimens is about 50 percent.~     Disappointingly most of cases are about to experience progression of disease.~      Second line regimens of palliative chemotherapy are also have shown its efficacy and~     recommended within patients with better performance status. But There is still lack of~     evidences in gastric cancer patients second line chemotherapy. Several phase II trial those~     subjects are 2nd line palliative chemotherapy in gastric cancer had suggested that~     irinotecan, taxane, oxaliplatin, oral fluorouracil.Investigator assessed whether cisplatin in~     combination with paclitaxel would increase response rate in patient previously treated for~     advanced gastric cancer compared with FOFIRI regimen.~   "
38113|NCT03067779|"~     This study is looking to improve the safety of patients with chronic kidney disease via~     education provided on a mobile tablet. This study will additionally examine if electronic~     tools, such as mobile tablets, can help.~   "
38116|NCT03067740|"~     Fifty two children of American Society of Anesthesiologists (ASA) physical status I and II,~     aged 8-14 years old, of both gender, with suspected acute appendicitis scheduled for~     laparoscopic appendicectomy, were included in this study. Patients were randomized into group~     (B) and group (BD) with a 1:1 allocation ratio.At the end of surgery, and after peritoneal~     lavage, those patients who were allocated to B group (bupivacaine group; n = 26) received~     bupivacaine 0.25% intraperitoneally at a dose of 2 mg/kg followed by 5 ml normal saline.~     However, in group BD (bupivacaine, Dexmedetomidine group; n = 26), bupivacaine 0.25% at a~     dose of 2mg/kg was instilled intraperitoneally followed by dexmedetomidine 1mcg/kg diluted in~     5 ml normal saline. In the postoperative period, assessments were made for pain and sedation~     on awakening in PACU (0 time) and at 2, 4, 6, 12,and 24 h. Abdominal and/or shoulder pain was~     assessed on the 10-cm Visual Analog Scale (VAS). Sedation was assessed using the Ramsay~     sedation score. Also the occurrence of nausea or vomiting was recorded . The time from~     extubation to the first administration of pethidine was registered. The consumption of~     postoperative analgesia was recorded. Side effects of the study drugs were assessed and~     recorded by the ward nurses for 24h postoperatively. Possible complications such as~     respiratory depression, allergic reactions, local anaesthetic toxicity,dizziness, , headache,~     were recorded and managed accordingly. Duration of surgery and length of stay in PACU were~     noted. Before discharge to home, length of stay in the hospital was recorded and parent's~     satisfaction was assessed using the 7‑point Likert scale~   "
38117|NCT03067727|"~     To demonstrate the efficacy of dinoprostone vaginal insert (DVI) for cervical ripening~     success (either bishop score (BS) ≥7 or vaginal delivery) within 12 hours of vaginal insert~     administration~   "
38118|NCT03067714|"~     With the rising prevalence of allergic diseases and the subsequent risk of developing other~     immune-related disorders, primary prevention of allergy has become a major priority. It is~     generally acknowledged that breastfeeding is one of the main pillars in allergy prevention.~     Infant formulas based on hydrolysed proteins have been developed to be used by infants at~     increased risk of developing allergy in case a mother is unable or chooses not to breastfeed~     her infant. It has recently been demonstrated that the gut microbiota composition and~     microbiota activity of infants receiving an infant formula based on partially hydrolysed~     proteins, supplemented with oligosaccharides, is more similar to breastfed infants than to~     infants receiving standard cow's milk formula, demonstrated by increased levels of~     bifidobacteria. However the interaction between microbial changes impacted by an~     hypoallergenic concept and its influence on early life immune development should be further~     explored. The aim of the present study is therefore to investigate the bifidogenic effect of~     a hypoallergenic formula supplemented with prebiotics and probiotics compared to standard~     infant formula in infants at increased risk of developing allergic disease. This study will~     secondary assess the effects of this concept on the development of allergic manifestations up~     to the age of 12 months, which will be verified in a separate clinical study MAESTRO as~     primary outcome. Furthermore, the effects on growth and safety will be studied.~   "
38119|NCT03067701|"~     In healthy young adults 18-39 years of age, the investigators will determine if intermittent~     inhalation a 0.1% CO, from a 1-liter bag once every minute for 30-40 minutes, at a level that~     approaches the CO boost with hookah smoking, augments endothelial function, thus implicating~     CO as the major endothelial vasodilator substance in hookah smoke.~      Rationale: Our group has demonstrated (PRO36547) that in contrast to cigarette smoking,~     hookah smoking (tobacco heated with charcoal) acutely augments, rather than impairs, brachial~     artery FMD. Importantly, our data strongly implicate—but do not prove—that the augmentation~     in FMD is caused by CO. Therefore; the investigators would like to extend the scientific~     priority of this work by directly investigating cause and effect of CO breathing (similar~     levels than ones obtained after hookah smoking) on brachial artery FMD.~   "
38120|NCT03067688|"~     Randomized, double-blind, active-controlled, multicenter phase 3 trial to evaluate efficacy~     and safety of co-administrated temisartan/amlodipine and rosuvastatin in subjects with~     hypertension and hyperlipidemia.~   "
38121|NCT03067675|"~     The objective of this study is to collect OCT measurement data on normal healthy eyes.~   "
38122|NCT03067662|"~     A few, small randomized controlled trials have investigated the effects of exercise on blood~     glucose levels in women with gestational diabetes (GDM), with inconsistent results.~      To assess the effects of supervised exercise in women with GDM, 48 women with gestational~     diabetes, diagnosed between the 18th and 28th week of gestation, will be recruited, after~     exclusion of subjects with contraindications to exercise. These subjects will be randomly~     assigned to two groups: structured exercise intervention or standard care.~      Women in the intervention group will perform low intensity aerobic exercise three times per~     week at 30% HRR (heart rate reserve), under continuous heart rate monitoring. Duration of~     each session will progress from 26 minutes the first week to 40 minutes (increasing 2~     min/week). Women in the control group will receive standard diet and physical exercise~     recommendations.~      In all women, clinical, metabolic and anthropometric features will be assessed before, during~     and at the end of the study. Newborn data will also be collected.~   "
38123|NCT03067649|"~     The primary purpose of this study was to test whether conducting a brief motivational~     interview that focused on perceived barriers to treatment seeking would increase the~     likelihood that a parent with psychiatric problems would seek treatment for themselves.~   "
38124|NCT03067636|"~     Following the realisation that many aspects of the way we live our life, such as our diet,~     activity levels, and amount of screen time, can have a potent impact on mental health and~     brain functioning 'lifestyle' based interventions have become topical in medical research. In~     particular, much scientific attention has been devoted to the impact of physical exercise and~     various stress reduction techniques on mood disorders. We aim to extend this work and~     investigate their impact on compulsivity.~      We will do this by conducting a pilot proof-of-principal intervention study. The study will~     compare the impact of eight-weeks of:~        1. regular physical exercise + stress management activity A,~        2. regular physical exercise + stress management activity B,~        3. lifestyle as usual.~      The participant cohort will be adults who endorse mild-moderate behavioural compulsivity on~     one of the following domains:~        -  drinking alcohol~        -  gambling~        -  eating~        -  washing or cleaning~        -  checking~        -  ordering or arranging objects~   "
38128|NCT03067584|"~     Familial aggregation is well recognized in some cancers. Though a number of familial cancer~     predisposition syndromes have been described, the nature of inherited genetic alterations in~     patients with a strong history of familial cancer is currently unknown, as is the case with~     childhood acute lymphoblastic leukemia (ALL).~      The investigators are seeking to learn more about what causes leukemia and why some people~     and families may be at a higher risk of developing this disease. By understanding the origin~     of the disease, better treatments may be identified for patients with leukemia.~      PRIMARY OBJECTIVE: To identify variants in genes that are inherited, have altered gene~     structure and/or function, and influence the risk of developing acute lymphoblastic leukemia~     (ALL) and other cancers.~      SECONDARY OBJECTIVE: To collect demographic, clinical and laboratory information including~     detailed family cancer history and response of cancers to therapy for correlation with the~     primary objective.~   "
38129|NCT03067571|"~     The goal of this clinical research study is to learn if daratumumab can help to control acute~     myelogenous leukemia (AML) or high-risk myelodysplastic syndrome (MDS) that is refractory~     (does not respond to treatment) or relapsed (comes back after being treated).~      The safety of this drug will also be studied.~      This is an investigational study. Daratumumab is FDA approved and commercially available for~     treatment of multiple myeloma (MM). It is considered investigational to use it as treatment~     for AML or MDS.~      The study doctor can explain how the study drug is designed to work.~      Up to 36 patients will take part in this study. All will be enrolled at MD Anderson.~   "
38130|NCT03067558|"~     Pneumonia is the leading infectious cause of death among children under 5 years of age~     globally. Many pneumonia deaths result from late care seeking and inappropriate treatment due~     to misdiagnosis of symptoms. The United Nations Children's Fund's (UNICEF's) Acute~     Respiratory Infection Diagnostic Aids (ARIDA) project aims to introduce automated respiratory~     rate (RR) counting aids for use by frontline health workers in resource limited community~     settings and health facilities. These RR counting aids aim to offer improved accuracy,~     effectiveness and acceptability compared to current practices for counting and classifying RR~     to detect fast breathing pneumonia.~      The general aim of the controlled accuracy study is to understand whether the ARIDA test~     device accurately measures RR in children under 5 years of age with cough and/or difficult~     breathing. It is a cross-sectional, prospective study in a controlled setting comprising~     three types of device evaluations:~        1. The accuracy of the ARIDA test device in measuring RR in young infants 0 to <2months,~          children 2 to <12 months and 12 to 59 months when compared to a video panel reference~          standard will be established through the first evaluation.~        2. The consistency of the ARIDA test device will be established by determining the level of~          agreement between the measures of RR for two ARIDA test devices when used on the same~          child at the same time in those aged 2 to <12 months and 12 to 59 months through the~          second evaluation.~        3. A third evaluation on a different group of normal-breathing children aged 2 to 59 months~          will assess RR fluctuation over time due to ARIDA test device attachment.~      Evaluations 1 and 2 for accuracy and consistency will also be undertaken with expert~     clinicians (EC) conducting a manual RR count to further the evidence base around the~     performance of current standard practice in a controlled setting.~      The study is a cross-sectional, prospective study and will be conducted in paediatric in and~     outpatient departments Saint Paul's Hospital and Millennium Medical Collage in Addis Ababa,~     Ethiopia.~   "
38131|NCT03067545|"~     This project aims to investigate whether an increase in step rate can be used to reduce pain~     and injury causing movement patterns in runners who are currently experiencing achilles~     tendonopathy, iliotibial band syndrome, patellofemoral pain syndrome and medial tibial stress~     syndrome.~      Many injuries have been reported to share similar injury causing movement patterns. For~     example iliotibial band syndrome and patellofemoral pain syndrome have been reported to be~     caused by increased side to side drop of the pelvis and inward movement of the hip.~      Gait retraining is a method of changing the way people run in order to change movement~     patterns.Increasing step rate may present a gait retraining method that does not pose further~     injury risks and can be used across multiple different injury populations. Studies have shown~     increasing step rate can reduce frontal plane movement patterns at the pelvis, hip and foot~     as well as reducing sagittal plane joint angles such as ankle dorsiflexion. Based on the~     changes in movement patterns increasing step rate has been recommended as an intervention for~     the treatment of patellofemoral pain syndrome, medial tibial stress syndrome, iliotibial band~     syndrome and achilles tendonopathy. Therefore this study aims to investigate whether an~     increase in step rate can reduce pain and change injury causing mechanics in runners~     currently running with patellofemoral pain syndrome, iliotibial band syndrome, medial tibial~     stress syndrome or achilles tendinopathy.~      The aim of the project is to use a simple gait intervention, increasing step rate to~     investigate if this technique change can reduce pain immediately, at short term follow up and~     long term follow up. The project will also look at whether an increased step rate can be~     maintained at follow up and whether this changes movement patterns proposed to be the cause~     of injury.~      Runners will be recruited from local running clubs and competitions using poster~     advertisement at running clubs and emailed to running clubs~   "
38132|NCT03067532|"~     To overcome the obstacles of endoscopic surgery, the da vinci surgical robot system was~     applied to the various surgery area . And the complete understanding and practice of the~     robotic system is very important condition for successful robotic surgery.~      Investigator developed a home made robotic surgery simulator for novice robotic surgeons. And~     investigator want to study about the ability of home made robotic surgery simulator versus~     existing robotic simulation system.~   "
38133|NCT03067519|"~     Fast Track Surgery (FTS) was started in colorectal surgery, but was later applied to other~     surgical fields. Core elements include epidural or regional anaesthesia, perioperative fluid~     management, minimally invasive surgical techniques, pain control, and early mobilization and~     feeding. Beneficial effects of FTS include reduced costs, early hospital discharge, and~     increased availability of hospital beds.The main aim of this study was to explore the~     efficacy of FTS in the Rwandan surgical setting and to demonstrate the benefits of FTS.~      it is study comparing the management of surgical patients using traditional management and~     fast track surgery. the study was done on patients undergoing elective abdominal surgery only~   "
38134|NCT03067506|"~     The purpose of this study is to evaluate feasibility and compliance with a novel method for~     assessing mood and cognition in participants with major depressive disorder (MDD).~   "
38135|NCT03067493|"~     RAMEC is a phase II, multi-center, randomized trial with a safety test. There will be a~     safety test to establish the safety and tolerability of Neo-MASCT treatment and assess the~     immune response to the treatment.The randomized trial will assess DFS and immune response.~   "
38136|NCT03067480|"~     To determine whether 3-month versus 6-month professional CGM utilization improves time spent~     in target range of 70-140mg/dl in patients with poorly controlled T2DM not treated with~     insulin.~   "
38137|NCT03067467|"~     This is a non-randomized, purely observational, feasibility study to detect metabolic changes~     in patients with brain malignancy using a novel hyperpolarized [1-13C]pyruvate MRSI.~   "
38152|NCT03067272|"~     Prospective, multi-center, pilot study to evaluate the safety of the FemBloc™ Permanent~     Contraceptive System for female sterilization in preventing pregnancy.~   "
38153|NCT03067259|"~     The objective of this study will be to estimate the incidence of postoperative cognitive~     dysfunction (DCPO) in patients over 65 years of age, undergoing surgical / anesthetic~     procedures and in patients who will not undergo surgical / anesthetic. The patients will be~     taken from the Hospital Italiano de Buenos Aires.~   "
38154|NCT03067246|"~     A study comparing two second generation supraglottic Airway devices, the VBM intubating~     laryngeal tube and the I-Gel.~   "
38155|NCT03067233|"~     To develop and validate a reliable automatic analysis of the signals recorded during a~     polysomnography.~   "
38138|NCT03067454|"~     Spiral metacarpal fractures (metacarpal II-V) can be treated conservatively or with~     operation. With minimal displacement this fracture is usually treated with immobilisation or~     early mobilisation. With appreciable displacement especially any malrotation the patient~     usually is treated with an operation. This usually includes an open reduction of the fracture~     and fixation with plates and screws or just screws. Even if this is an standard procedure~     both mild and severe complications have been reported. New studies have shown that even~     displaced fractures can be treated with early mobilization. In those cases the fractures may~     heal with some shortening but very good function. An advantage of early mobilization is that~     the patient avoids the risk of an operation and the costs for the treatment are decreased~     markedly. The study is designed to answer the question if early mobilization is not inferior~     to operative treatment but with lower costs and without any operation related risks.~   "
38139|NCT03067441|"~     The purpose of this study is to see if bempedoic acid (ETC-1002) is safe and well-tolerated~     in patients with high cardiovascular risk and elevated LDL cholesterol that is not adequately~     controlled by their current therapy.~   "
38140|NCT03067428|"~     Nonalcoholic fatty liver disease (NAFLD) is an emerging health problem as it can lead to end~     stage liver failure and cardiovascular complications. Diet play an important role in the~     development of NAFLD. Many studies have addressed the effects of added fructose on NAFLD. To~     date, little attention has been paid to the effects of a diet devoid of fructose. Therefore,~     the investigators aim to study the effects of fructose restriction on hepatic fat~     accumulation and vascular function using a double-blind randomized placebo-controlled design.~   "
38141|NCT03067415|"~     Exploratory trial to evaluate the efficacy and safety of D565H twice daily versus D565 once~     daily.~   "
38142|NCT03067402|"~     The ROSSTAR trial is a pragmatic trial that will directly compare the strategies of routine~     and selective stress imaging testing (with radionuclide imaging (RNI)) late after PCI or CABG~     in asymptomatic patients. The study will be a single center trial based at the Jewish General~     Hospital (JGH), a McGill University teaching hospital (Montreal, Quebec). A total of 1100~     patients who are either >5 years post-CABG or >2 years post-PCI will be randomized. Half of~     the patients will be randomized to a routine RNI testing, and the other half to selective RNI~     testing.~   "
38143|NCT03067389|"~     A prospective, non-interventional study in women 18 to 84 years of age. Subjects will provide~     a sample for genetic testing and information about their medical and family history. The~     results of the genetic test will be combined with clinical data to validate a method of~     predicting breast cancer risk.~   "
38144|NCT03067376|"~     The study was designed to evaluate how CORT125134 is taken up, broken down and removed from~     the body when given as an oral capsule to healthy subjects.~   "
38145|NCT03067363|"~     This is the first in human study of MOR107. It is a 2 part, single centre, double-blind,~     randomised, placebo-controlled study in healthy male subjects. Part 1 is a single ascending~     dose study, and Part 2 is a parallel group, dose range finding study in healthy male subjects~     on a low sodium diet.~   "
38146|NCT03067350|"~     Hypothesis: A pharmacogenetic score integrating both CYP3A genotypes could be influence~     initial trough voriconazole plasma concentrations and thus useful to adapt a priori~     voriconazole dosing in order to get adequate voriconazole exposure as possible after starting~     treatment.~      Main Objective: To determine predictive value of a combined pharmacogenetic score on onset of~     trough voriconazole plasma concentration inferior than lower therapeutic target.~   "
38147|NCT03067337|"~     Introduction and Research Problem:~      The aim of this project is to evaluate and compare two full coronal restorations on primary~     posterior molars over a period of 3, 6 and 12 months in terms of restoration failure,~     marginal integrity, proximal contact, secondary caries, occlusion and gingival response. The~     restorations types are Stainless Steel Crowns (SSC) and NuSmile Zirconia Crowns (Nu/ZR).~      Materials and Methods:~      Children attending the King Abdulaziz University, Faculty of Dentistry (KAUFD) clinics who~     need restorations will be screened for inclusion criteria till 120 teeth are recruited (60~     teeth for SSC restorations and 60 for Nu/ZR restorations). Split mouth technique will be used~     to ensure equalizing variables for both groups, each patient will have side restored with SSC~     and the opposite side will be restored with Nu/ZR crowns.~      Randomization will be done using Statistical Package for the Social Sciences (SPSS) software~     version 20.0 (Armonk, New York; International Business Machines Corporation (IBM Corp) for~     each age group separately with a uniform random variable generation. A simple descriptive~     statistics will be used for analysis and a T-Tests with Wilcoxon Signed-Rank will be used.~     Level of significance will be set at (α = 0.05) and level of confidence at (95%).~   "
38148|NCT03067324|"~     Islet quality control after pancreatic islets isolation process is insufficient. The Islet~     Chip study proposes to develop a bio-sensor that will allow a multi-parametric analysis of~     islet graft based on measurement of islet membrane electric potential.~   "
38149|NCT03067311|"~     To test the feasibility of a clinical trial implementing I-CAT, a novel therapeutic~     intervention combining strategies to improve stress reactivity and increase meaningful~     coping, as well as a range of possible proximal (e.g. autonomic, endocrine, immune indices of~     stress reactivity, symptom severity) and distal measures (function, relapse, quality of life)~     for 40 people with first episode psychosis in the context of a small randomized controlled~     trial.~   "
38150|NCT03067298|"~     Preterm birth (PTB), preeclampsia (PE), fetal growth restriction (FGR) and intra-uterine~     fetal death (IUFD) constitutes the main causes of perinatal morbidity and mortality and are~     called Great Obstetrical Syndromes. Algorithms to predict those outcomes have been~     developed by combining maternal characteristics (history, age, BMI, blood pressure),~     biochemical (sFlt-1, β-hCG, PlGF, AFP) and sonographic (uterine artery Doppler, 3D of~     placenta, cervical length, nasal bone measurement, nuchal translucency) markers. Another~     prospective observational study (PREDICTION study NCT 02189148) is also ongoing, which aims~     to validate those algorithms at the first trimester of pregnancy.~      Recent data suggest that repeating the same measurements later in pregnancy could improve the~     detection rates, allowing closer monitoring of high-risk patients and potential therapeutics~     under investigation. The current study (PREDICTION2) is an ancillary study of PREDICTION and~     aims at validating the use of these markers in a combined iterative manner in the prediction~     of preeclampsia and other obstetrical outcomes.~   "
38157|NCT03067207|"~     This study will seek to compare the effect of a mindfulness meditation program for~     adolescents with chronic illness delivered either in person or via an online platform. The~     8-week program will combine meditation practices, breathing exercises and group discussions.~     Participants will be recruited from different general and specialized clinics at the Hospital~     for Sick Children and will be allocated to either an in-person or the online group through a~     random process (like tossing a coin). The study will aim to recruit 60 participants ages~     13-18. Each participant will provide data through research questionnaires, recorded~     interviews and saliva samples.~   "
38158|NCT03067194|"~     The purpose of this study is to evaluate efficacy and safety of Celecoxib capsule in hand~     osteoarthritis patients.~   "
38159|NCT03067181|"~     This partially randomized phase III trial studies how well active surveillance, bleomycin,~     carboplatin, etoposide, or cisplatin work in treating pediatric and adult patients with germ~     cell tumors. Active surveillance may help doctors to monitor subjects with low risk germ cell~     tumors after their tumor is removed. Drugs used in chemotherapy, such as bleomycin,~     carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading.~   "
38160|NCT03067168|"~     To determine if levator muscle block with bupivacaine improves postoperative pain control~     relative to placebo controls among women undergoing prolapse surgery involving a posterior~     colporrhaphy. Improvement is defined as no less than a 25% lower total pain score on a ten~     point numerical pain scale.~   "
38161|NCT03067155|"~     Viral infections remain an important cause of morbidity and mortality after allogeneic stem~     cell transplantation (SCT), especially after myelo-ablative conditioning and if the donor is~     antigen-mismatched or haplo-identical.. In the described setting the patient's own immune~     system has been destroyed by the necessary highly immuno- and myelo-ablative conditioning and~     all memory against infections has been deleted. Therefore, there is a high risk for several~     viral infections and other infectious organisms.Both primary viral infections and~     reactivations can occur, and patients can become refractory to antiviral treatments, or in~     some cases an adequate antiviral treatment is unavailable or too toxic. In this study, the~     investigators will target CMV, as refractory CMV infection and disease is accompanied by an~     extremely high mortality rate and therefore the development of new treatment approaches is~     required. Despite the available antiviral drugs, a considerable number of patients are facing~     an insufficient control of CMV reactivation after SCT. Because reconstitution of CMV-specific~     T cells confer protection against the development of CMV disease after SCT, attempts have~     been made to restore antiviral immunity by direct infusion of CMV-specific T cells. Most~     clinical cellular immunotherapy protocols for CMV treatment have used CMV-specific cytotoxic~     CD8+ T-cell lines generated by repetitive in vitro stimulation with CMV antigens with~     success. Despite the proven efficacy, use of cellular therapy in the clinic has been limited,~     because the approach is time and labor consuming and requires specialized facility allowing~     handling of the therapeutic cells according to good manufacturing practice. In addition, no~     sustained response was seen after adoptive transfer that involved only cytotoxic CD8+ T~     cells. This phenomenon is supported by the fact that recall responses to latent infections~     depend on the presence of CD4+ T cells to help cytotoxic CD8+ T cells. An alternative~     approach for the transfer of T-cell immunity is the isolation of Ag-specific T cells ex vivo~     from the blood of CMV seropositive donors, based on interferon γ (IFN-γ) secretion of T cells~     after in vitro stimulation with viral Ag, resulting in a combination of CD4+ T helper and~     cytotoxic CD8+ CMV specific T cells. Using this strategy, a short-term ex vivo protocol was~     developed for the isolation of pp65 (CMV immunodominant protein)-specific T cells. Since~     then, several centers have used this protocol in the clinic, infusing low numbers of~     pp65-specific T cells, that were able to restore protective T-cell immunity against CMV in a~     post SCT setting in patients with refractory CMV disease or viremia. For this protocol the~     investigators have set up and validated this method of CMV-specific T-cell generation in the~     Ghent University Hospital and the investigators will make it available for other Belgian~     transplant centers.~   "
38162|NCT03067142|"~     The purpose of this study is to identify unique urine protein markers of Primary~     Hyperoxaluria type 1 (PH1) compared to healthy controls. Urine protein markers can be~     identified by proteomic analyses in which proteins are processed in a lab to break them~     down into smaller building blocks. Using analytical chemistry techniques and specialized~     equipment many proteins can be identified and measured. Most proteins are found in healthy~     living cells while subtle changes in these proteins or the presence of different markers~     reflect abnormal processes and patterns of disease. When identified in disease, protein~     biomarkers can help to determine if a disease responds to new types of therapies. In this~     study, changes in urine proteomic patterns over time, their association with change in~     estimated (calculated) kidney filtering function, and the relative risk for progression of~     PH1 will be determined. Additionally, as part of the study, the investigators will measure~     urinary proteins and peptides that are markers of kidney tissue protection (for healthy~     healing of the kidneys from ongoing damage from high urine oxalate levels, oxalate crystals~     and stones) to establish if and when these markers are prospectively decreased in PH1 urine.~     Longitudinal studies of urine proteomics may assist in identifying the mechanisms behind~     PH1-related progression of kidney failure and might contribute important information towards~     future identification and development of effective therapies to slow or prevent kidney~     failure in PH1.~   "
38163|NCT03067129|"~     An open-label study to assess the pharmacokinetics (PK), safety, and efficacy of glecaprevir~     (GLE)/pibrentasvir (PIB) in pediatric participants divided into 4 age groups: 3 to < 6, 6 to~     < 9, 9 to < 12, and 12 to < 18 years of age. Within each age group, some participants will be~     enrolled for intensive pharmacokinetics (IPK) to characterize the PK of a particular age~     group and the remainder of participants will be enrolled for the evaluation of safety and~     efficacy of each age group. Intensive PK sampling is designed to allow for dose adjustment,~     based on available PK and clinical data to achieve therapeutic exposures that have been safe~     and efficacious in adults.~      Part 1 of the study will enroll participants into Cohort 1; Cohort 1 will include~     participants who are in 12 to < 18 years of age who can swallow the adult formulation of~     GLE/PIB. Part 2 of the study will enroll participants in the remaining age groups into~     Cohorts 2, 3, and 4; participants in these cohorts will receive the pediatric formulation of~     GLE/PIB. All participants will receive GLE/PIB for 8, 12, or 16 weeks depending on their~     hepatitis C virus (HCV) genotype, cirrhosis, and prior treatment experience status.~   "
38164|NCT03067116|"~     Determine balance changes during pregnancy~   "
38175|NCT03066973|"~     This study aimed to assess the efficacy of breathing exercises (BE) during the second stage~     of labor for maternal pain, duration of labor and first-minute APGAR score. This is a~     randomized controlled trial that compares nulliparous pregnant in the second stage of labor~     instructed regarding BE with a control group (CG) that received standard care service. It was~     conducted at Nenehatun Obstetric and Gynecology Hospital between May-June 2016, in Erzurum.~     One session of BE training were given to pregnant in intervention group (IG). Visual Analog~     Scale (VAS) was performed to identify perception of pain to all pregnant during the second~     stage of birth. Time of the second stage was recorded as second (sec), and first minute APGAR~     scores were recorded. Significance was set at p<0.05.~   "
38165|NCT03067103|"~     Adenotonsillectomy is one of the most common ambulatory surgical procedures performed to~     children. Tonsillectomy or adenotonsillectomy have a high incidence of postoperative pain.~     There is still debate about the optimal analgesia for this common surgical procedure.~     Different methods have been described and used to reduce pain including; improved~     intraoperative anesthetic pain regimens, use of corticosteroids, adjustment of surgical~     technique, and intraoperative local anesthetic injection. Intraoperative local anesthetic is~     a preventive or preemptive analgesia which is the analgesia given before painful stimuli to~     prevent the subsequent pain. The main goal of the preventive analgesia is the pain relief~     with minimum side effects. The role of local anesthetic infiltration in the reduction of~     postadenotonsillectomy pain is still controversial. The objective of this study is to~     investigate and compare the effectiveness of preincisional peritonsillar infiltration of~     ketamine and tramadol for post-operative pain on children following adenotonsillectomy. This~     is prospective, double-blinded randomized study.~   "
38166|NCT03067090|"~     Osteoarthritis (OA) causes degradation and deformities of joints, including knees, hips,~     hands, and feet. Approximately more than 55% of populations above 45 years and more than 70%~     of population above 70 years will develop OA in at least one joint. The symptoms are~     dominated by pain but also stiffness and swelling occur. There is currently no cure for OA,~     and the ultimate treatment is joint replacement surgery. However, there is an unmet need to~     identify other treatment options that may delay or avoid surgery.~      Aquamid Reconstruction (AR) is a polyacrylamide hydrogel (PAAG) which is a non-degradable,~     highly visco-elastic synthetic gel, which is atoxic with durable effect and~     tissue-compatibility and well tolerated by mammal tissue by allowing in vivo vessel and~     fibrous in-growth. Experimental studies supported by histopathological observations have~     shown that AR exerts its effect via integration over time within the soft tissues, through a~     combination of vessel in-growth and molecular water exchange. Intra-articular injection of AR~     is expected to provide permanent pain relief and improve the functional ability through a~     cushioning or padding effect on the joint and thereby reduce symptoms and improve patients'~     quality of life.~      The purpose of this study is to obtain information of the safety and effectiveness of AR in~     patients with OA of the knee.~   "
38167|NCT03067077|"~     Subjects will undergo SMILE surgery in one eye and LASIK surgery in their other eye to~     correct myopia.~   "
38168|NCT03067064|"~     The purpose of this study is to find out the prevalence of molar incisor hypomineralization~     among a group of Egyptian children~   "
38169|NCT03067051|"~     The rationale for the study is to obtain safety data as well as to establish dose parameters~     for the SpectraCure P18 System with IDOSE®, with verteporfin for injection (VFI) as~     photosensitizer for the treatment of recurrent prostate cancer.~   "
38170|NCT03067038|"~     Laparoscopic cholecystectomy (LC) became the standard treatment for symptomatic gallbladder~     disease. Single incision laparoscopic surgery (SILS) was developed with the aim of reducing~     the invasiveness of conventional laparoscopy. The aim of this study was to compare the~     clinical outcome of single-incision laparoscopic cholecystectomy (SILC) with three port~     laparoscopic cholecystectomy (TPLC).~   "
38171|NCT03067025|"~     Most youth with MS experience symptoms such as depression and fatigue. In addition, cognitive~     issues, especially with attention and memory occur frequently. However, little is known about~     interventions that might work to improve these symptoms. In other work, the investigators~     have shown that higher levels of physical activity are associated with lower levels of~     depression and fatigue. Importantly, sleep problems are frequently encountered in youth with~     MS, and were seen in 60% of surveyed youth with MS in the investigators preliminary work.~     Modifiable lifestyle factors such as sleep and physical activity (PA) may play a key role in~     ameliorating common symptoms in pediatric MS. However, sleep has not been objectively~     described in pediatric MS, and the relationship between PA and sleep is poorly understood.~     This study aims to address these gaps.~   "
38172|NCT03067012|"~     The metabolic effect of oncometabolic surgery (long limb Roux-en Y reconstruction) for early~     gastric cancer patients has been revealed in a few pilot studies. However, the nutritional~     safety has not been dealt with in previous literatures. This is a prospective pilot study for~     evaluating the nutritional safety and metabolic benefits of oncometabolic surgery for obese~     early gastric cancer patients.~   "
38173|NCT03066999|"~     The Center for Disease Control and Prevention (CDC) reports that one in four patients~     hospitalized in the United States is catheterized to void the bladder or monitor urinary~     output. In the male population, Dr. Singh, an urologist estimates that about 20% of~     catheterizations are difficult. Driving a catheter blindly, guessing whether to push the~     catheter forward or manipulate it to get around a point of resistance leads to the risk of~     injury which increases the more the catheter is manipulated. Additional adverse events~     include: urosepsis, UTI and bladder perforation. The standard of care treatment for patients~     with difficult urinary catheterization (DUC) is to proceed with a cystoscopic catheter~     placement or suprapubic tube placement.~      PercuVision has the only Foley catheter with a micro-endoscope for visualization and~     navigation of the urethra for nurses and other qualified health care professionals. Moreover,~     it allows urologists to place a guidewire under direct vision rather than calling for a~     flexible cystoscope which is considered a minor procedure.~      In this study, the investigators plan on assessing the effectiveness and ease of use of the~     PercuVision DirectVision® System device.~   "
38174|NCT03066986|"~     The purpose of this study is to assess the potential use of delta-inulin as an adjuvant to~     facilitate the desired immune response to Jack Jumper Ant (JJA) venom with a lower dose of~     venom, thus reducing adverse reactions, venom requirements and costs of treatment.~     Specifically we aim to compare outcomes of in-hospital JJA sting challenges and JJA venom~     specific IgE, and IgG4 responses to semi-rush JJA VIT at maintenance doses of 25 and 50 mcg~     of JJA venom, with and without delta-inulin adjuvant.~   "
38176|NCT03066960|"~     The researchers are planning a two-center double blind, sham-controlled randomized trial (N:~     44) to assess the long term efficacy of RF neurotomy of cervical medial branches. Patients~     with chronic neck pain who are found eligible and achieve >75% pain relief to predictive test~     blocks, can be included. Demographic and clinical data will be recorded at baseline while~     primary and secondary outcome measurements are recollected after 3, 6, 9 and 12 months.~     Primary outcome measurements include self reported neck function (NDI) and pain relief.~     Regression analyses will be used to identify how >75% pain relief of a two blocks predicts~     response to RF neurotomy.~   "
38177|NCT03066947|"~     This is a single arm, open label study of SV-BR-1-GM, a targeted immunotherapy for breast~     cancer. Eligible patients will have histological confirmation of breast cancer with recurrent~     and/or metastatic lesions. The treatment regimen includes a pre-treatment with low-dose~     cyclophosphamide 2-3 days before the inoculation; inoculation in 4 sites on the thighs and~     upper back; and post-treatment inoculation of Interferon-alpha-2b into the sites of~     inoculation ~2 and ~4 days after the inoculation. These is repeated every 2 weeks for one~     month (3 treatments), then monthly for up to one year. Standard tumor assessments are~     performed at baseline and then every 2-3 months.~   "
38178|NCT03066934|"~     Noninvasive ventilation (NIV) is an alternative form of ventilatory support in critical care~     encompassing different modes of ventilation such as continuous positive airway pressure~     (CPAP), bilevel positive airway pressure (BiPAP) and high flow nasal cannula ventilation.~     Although numerous studies on adults exit in literature, the aspects of this ventilatory~     support is limited in pediatric age groups. Early recognition of respiratory failure and~     initiation of NIV in a pediatric patient would positively affect prognosis by avoiding~     certain complications of endotracheal intubation and mechanical ventilation and adds certain~     advantages. Decreasing re-intubation rates for the ones who are extubated but necessitating~     further oxygen support is another advantage of NIV. Although numerous studies on adults exit~     in literature, the aspects of this ventilatory support is limited in pediatric age groups.~     Besides, success as well as failure and complication rates in pediatric age groups vary~     extensively. This multi-centered, prospective cohort study is planned to observe the~     epidemiologic perspectives of study group within underlying problems, success rates between~     different age groups, complication and re-intubation rates and finally its' effect on~     prognosis and long term survival in a year period. Hence we believe results of this study~     would allow us to improve our knowledge on using this technique, applying different modes and~     parameters appropriately and design criteria to guide clinician in deciding which group of~     patients would benefit from NIV techniques.~   "
38179|NCT03066921|"~     Previous studies found that lactic acid bacteria could inhibit the activity of the~     performance of aristolochic acids (AAs) and improve apoptosis of proximal tubular epithelial~     cells (NRK-52E) and renal fibrosis on rats. The aim of this study is to assessment a novel~     health food of lactic acid bacteria for preventing renal dysfunction and replacing or~     assisting conventional drug treatment. This study in 300 hemodialysis patients with dialysis~     quality assessment index (KT/V, urea reduction ratio (URR), albumin, prealbumin, Hb, CRP…)~     screened for more than three months, and the stability of the situation in dialysis patients.~     They will be divided into two groups in order to conduct ergonomic assessments. One group~     maintains their original diet and medicine. The other group will take the novel lactic acid~     bacteria and placebo (1x1011 cfu/3±0.2 g/bag) in every morning and evening after their meals.~     The effect of 0, 6, 12, 18, 24 weeks of the novel lactic acid bacteria will be assessed after~     starvation for 4 weeks. Group C was the control group did not give any test samples, but~     continued to observe. The overall goal of the aforementioned study is to develop a novel food~     product of lactic acid bacteria which can improve dialysis quality for hemodialysis patients.~     The investigators hope that this novel product can get a patent and be commercialized.~   "
38180|NCT03066908|"~     A prospective, single arm, multicenter study designed to demonstrate that the Sinopsys®~     Lacrimal Stent can safely create transcaruncular access to the ethmoid sinus to enable sinus~     irrigation and reduce symptoms in patients with moderate to severe chronic rhinosinusitis.~   "
38181|NCT03066895|"~     This is a pilot, randomized, safety and efficacy study of an investigational device (i.e.~     BabyGentleStick™; BGS, Actuated Medical, Inc). The primary study objectives are to obtain~     subject feedback, assess device performance; and ascertain potential harm in healthy adult~     volunteers.~   "
38182|NCT03066882|"~     Negative-calorie diet is among the popular dieting guides for weight loss; however, there is~     still little knowledge about this method. The present study aimed to determine the effects of~     negative-calorie diet on weight loss and lipid profile, and to compare its efficiency with~     low-calorie diet.~   "
38183|NCT03066869|"~     The purpose of this study is to evaluate the short- and long-term efficacy and safety of~     Acthar for the treatment of adults with non-infectious retinal vasculitis.~   "
38184|NCT03066856|"~     Insulin-like growth factor I (IGF-I) and other markers of insulin resistance (IRm) might~     modulate the penetrance of BRCA genes mutation.~      The investigators have designed a demonstration project with BRCA mutation carriers (with or~     without a previous diagnosis of breast cancer) to test:~        1. whether a lifestyle intervention significantly reduceIGF-I and the other IRm (randomized~          trial).~        2. whether mutation carriers with a previous diagnosis of breast cancer have higher IRm~          than carriers without breast cancer (case-controlstudy).~        3. whether IRm and their change over time affect subsequent breast cancer incidence and~          prognosis (cohort follow-up).~      The investigators expect to significantly reduce IGF-I and IRm, to find that BRCA mutation~     carriers with a previous breast cancer have higher IRm levels, and, in the long term, that~     women with persistent higher IRm levels have higher penetrance and worst prognosis.~      Confirming a significant reduction of IRm and the impact of their levels on prognosis would~     help to develop primary prevention recommendations for high risk families.~   "
38185|NCT03066843|"~     This is a randomized clinical trial evaluating blue light 5-aminolevulinic acid (ALA)~     photodynamic therapy with different incubation times for the treatment of actinic keratosis.~      Subjects who are interested in participating, currently living in the Chicago metropolitan~     area, and meet inclusion and exclusion criteria will be enrolled in the study. Subjects will~     be randomized to either 1) zero time ALA incubation or 2) 1 hour ALA incubation. Demographic~     and health data will be collected prior to treatment initiation. Three visits will be~     conducted: screening, treatment, and follow up visit at 8 weeks.~      This study is a pilot study designed to determine feasibility of this procedure.~   "
38200|NCT03066648|"~     To characterize the safety and tolerability of PDR001 and/or MBG453 in combination with~     decitabine in relapsed/refractory AML patients, de novo AML patients who are not candidates~     for standard induction therapy, or high risk MDS patients, and to identify recommended doses~     for future studies.~   "
38304|NCT03065283|"~     The aim of this study was to evaluate the immediate effects of diaphragmatic release~     techniques on posterior chain flexibility and lumbar spine amplitude. Respiratory muscle~     strength and chest cavity mobility in healthy women.~   "
38186|NCT03066830|"~     Primary Objective:~      To demonstrate the superiority of sotagliflozin 400 mg versus placebo on Hemoglobin A1c~     (HbA1c) reduction at Week 26 in patients with type 2 diabetes (T2D) who have inadequate~     glycemic control with a sulfonylurea alone or in combination with metformin.~      Secondary Objectives:~        -  To compare sotagliflozin 400 mg versus placebo based on:~        -  Change from baseline in fasting plasma glucose (FPG).~        -  Change from baseline in systolic blood pressure (SBP) for patients with baseline SBP~          ≥130 mm Hg.~        -  Change from baseline in SBP for all patients.~        -  Change from baseline in body weight.~        -  Proportion of patients with HbA1c <6.5% and <7.0%.~        -  To evaluate the safety of sotagliflozin 400 mg versus placebo throughout the 79-week~          trial.~   "
38187|NCT03066817|"~     Although vitamin D is known to play a major role in multiple organ functions in healthy~     adults, including bone homeostasis, its role in the unique population of orthopaedic~     polytrauma patients has not been well described. The aim of this therapeutic randomized~     placebo-controlled feasibility study is to determine the effect of vitamin D supplementation~     initiated on admission on patients' 25(OH)-D level, bone turnover markers, and clinical~     outcomes in a cohort of adult orthopaedic polytrauma patients. Polytrauma patients with one~     or more orthopaedic injuries admitted to an urban Level I trauma center will be screened for~     eligibility based upon strict inclusion and exclusion criteria. Sixty patients meeting the~     criteria will be consented, enrolled and randomized in a 1:1 ratio to intervention and~     control (placebo) arm. Baseline 25(OH)-D and bone turnover marker levels will be drawn for~     all the patients on admission, and the intervention arm will receive a one-time dose of~     ergocalciferol (Vitamin D2) 400,000 IU shortly after enrollment. The labs will be repeated 7~     days after the initial draw or at discharge, whichever occurs first. Patients' daily~     immobilization status, baseline characteristics and clinical outcomes will be recorded.~     Statistical methods will be used to assess whether there is a difference in 25(OH)-D and bone~     turnover markers levels associated with the intervention.~   "
38188|NCT03066804|"~     The purpose of this study is to demonstrate the superiority of LCZ696 over individualized~     medical therapy for comorbidities in reducing N-terminal pro-brain natriuretic peptide~     (NT-proBNP) and improving HF symptoms and functional capacity in patients with heart failure~     with preserved ejection fraction (HFpEF).~   "
38189|NCT03066791|"~     A noticeably increasing number of patients are asking for naturally based extracts and~     ingredients as supplementary dermatologic remedies. Patients are seeking natural and~     cost-effective skin care alternatives in place of prescription medications and procedures.~     Our study will evaluate the effects of oral curcumin and turmeric on sebum production in~     healthy subjects.~   "
38190|NCT03066778|"~     The purpose of this study is to assess the safety and efficacy of pembrolizumab plus standard~     of care (SOC) chemotherapy (etoposide/platinum [EP]) in participants with newly diagnosed~     extensive stage small cell lung cancer (ES-SCLC) who have not previously received systemic~     therapy for this malignancy.~      The primary study hypotheses are that pembrolizumab+EP prolongs Progression-free Survival~     (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by blinded~     independent central review (BICR) and Overall Survival (OS) compared with placebo+EP in adult~     participants with ES-SCLC.~   "
38191|NCT03066765|"~     Study of tongue implant for treatment of obstructive sleep apnea~   "
38192|NCT03066752|"~     Up to 65% of patients with multiple sclerosis (MS) experience cognitive dysfunction.~     Diminution of mental capacity has a pervasive and profound impact on their quality of life.~     Subtle changes in white matter predict cognitive changes in these patients but how this~     disrupts brain function remains unclear. Development of effective therapeutics to restore~     normal cognition hinges on elucidating these functional changes. The investigators seek to~     uncover the patho-physiological basis for cognitive decline in MS. The investigators~     hypothesize that cognitive decline originates from disrupted gamma oscillations and that~     gamma oscillations are disrupted by molecular changes triggered by demyelination.~   "
38193|NCT03066739|"~     The purpose of this study is to evaluate whether using ultra-low dose naloxone, an opioid~     antagonist, has the potential to block remifentanil-induced hyperalgesia and tolerance~     following surgery.~      There are 3 study groups: (1) low dose remifentanil (LO, 0.1 micrograms/kg/mL), (2) high dose~     remifentanil (0.4 mg) combined with placebo (HI, 0.4 micrograms/kg/mL), or (3) high dose~     remifentanil (0.4 mg) combined with ultra-low dose naloxone (HN, 0.004 micrograms/kg/mL~     naloxone).~      The hypothesis of the study is that occurrence of remifentanil-induced hyperalgesia (low~     score in mechanical pain threshold) in the HN group will be lower than in the HI group.~   "
38194|NCT03066726|"~     Ultrasound Doppler studies are used during pregnancy to help manage pregnancies complicated~     by fetal growth restriction. The cerebroplacental ratio may predict adverse outcomes in low~     risk pregnancies. In a prospective study, the investigators will examine whether fetuses with~     an abnormal CPR at or near term are at increased risk for being delivered by cesarean,~   "
38195|NCT03066713|"~     Assess the impact of high antioxidant potato products on postprandial glycemic response and~     subsequent appetite and food intake.~   "
38196|NCT03066700|"~     This is a retrospective study to identify the prognostic factors of the good outcomes in~     patients who presented with upper GI bleeding from tumor and received Hemospray via endoscopy~     for hemostatic control. The good outcomes were assessed by immediate hemostasis, rebleeding~     at 72 hours as well as 7, 14 and 30 days following presentation at initial bleeding episode~     and also 6-month survival rate.~   "
38197|NCT03066687|"~     The primary purpose of this study is to evaluate the effect of food on the relative~     bioavailability of a single 9 milligram (mg) oral dose of erdafitinib in healthy~     participants.~   "
38198|NCT03066674|"~     Low back pain (LBP) is one of most prevalent types of musculoskeletal pain and is strongly~     related to disability. The McKenzie method is one of most popular treatment options for LBP.~      The objectives of this study are to determine the effect of the hands-on McKenzie program on~     pain, disability, spine mobility, and posture deviations in subjects with derangement low~     back pain.~   "
38199|NCT03066661|"~     Expanded access to entrectinib will be given to patients with cancers harboring NTRK1/2/3,~     ROS1, or ALK gene fusions who do not qualify for participation in, or who are otherwise~     unable to access, an ongoing clinical trial for entrectinib.~   "
38201|NCT03066635|"~     Cluster headache (CH) is the most common of the trigeminal autonomic cephalalgias and one of~     the most severe pains known to man, having a large impact on the sufferer's quality of life.~     A parasympathetic dysfunction in CH has been suggested. The sphenopalatine ganglion has been~     a target for treatment of primary headache disorders for more than a century but there are~     several anatomic and physiologic studies that suggest that another cranial parasympathetic~     ganglion, the otic ganglion (OG), might be also relevant in CH. In this study OG will be~     blocked with botulinum toxin type A in a pilot study in 10 patients with chronic cluster~     headache. Recruitment of patients will be solely in Norway. There is no data available to~     determine the correct dosage of botulinum toxin. A similar neural structure that has been~     blocked with botulinum toxin in humans is the sphenopalatine ganglion. The investigators~     injected 10 patients suffering from intractable chronic cluster headache with botulinum toxin~     in the sphenopalatine ganglion. 5 patients were given 25 IU and 5 patients were given 50 IU.~     Even though the number of treated patients is low, there did not appear to be differences in~     the adverse events profile between those who received 25 Iu and those who received 50 IU. The~     investigators also previously injected 25 IU botulinum toxin towards the sphenopalatine~     ganglion bilaterally (i.e. 25 IU in each side) in 10 patients suffering from intractable~     chronic migraine. Doses of up to 25 IU have been injected in structures adjacent to the otic~     ganglion, for instance in dystonia towards the lateral pterygoid muscle. Thus it was decided~     for this study on injection towards the otic ganglion, to explore the safety of 12.5 and 25~     IU of botulinum toxin.~   "
38202|NCT03066622|"~     This trial is a prospective, randomized, feasibility trial with the primary aim of comparing~     how well oral rapidly dissolving olanzapine controls primary headache pain when compared to~     the current treatment strategies used in emergency departments which often require~     intravenous or intramuscular medications.~   "
38203|NCT03066609|"~     The purpose of this study is to determine if secukinumab is effective and safe in the~     treatment of plaque type psoriasis~   "
38204|NCT03066596|"~     The overall goal of this research study is to test the effectiveness of a multifaceted and~     multi-level prompting intervention in a real world urban primary care office setting on~     improving provider-delivered guideline-based asthma care and reducing asthma morbidity among~     urban children with persistent or uncontrolled asthma.~   "
38205|NCT03066583|"~     This study will compare meniscal healing augmented or without augmentation with platelet rich~     plasma in primary meniscal tear treatment (prolotherapy). The assessments will include~     validated, disease specific, patient oriented outcome measures. Results of this study will~     help ascertain whether platelet rich plasma may improve meniscal healing rates.~   "
38206|NCT03066570|"~     Objective: To investigate the effects of a cognitive behavioural intervention targeting~     specific fears in patients with painful diabetic neuropathy, on physical activity and quality~     of life.~   "
38207|NCT03066557|"~     Hepatocellular carcinoma (HCC) is the most common primary malignant tumor of the liver. It is~     lack of effective drugs for systemic treatment of HCC. Currently, Sorafenib is the only~     choice approved by FDA for advanced HCC, although it prolongs the survival for less than 3~     months. The treatment of advanced HCC still has a long way to go.~      At present, the relevant phase II and phase III clinical studies of apatinib on advanced HCC~     are ongoing. Based on our important discovery of previous clinical studies, we intend to~     enlarge the sample size and make further observation for the efficacy and safety of apatinib~     in patients with advanced HCC.~   "
38208|NCT03066544|"~     The main goal of this study is to determine whether it is possible - in the setup of routine~     clinical care - to identify in individual patients who are clear responders to drug X, common~     denominators that are absent in individual patients who are non-responders to the same drug,~     and vice versa. All currently available knowledge about migraine pathophysiology will be~     utilized, using as much time as is needed to ask as many questions as are necessary, in an~     attempt to profile clear responders and clear non-responders.~   "
38209|NCT03066531|"~     The purpose of the present study is to compare an Acceptance and Commitment Therapy (ACT)~     group intervention and a Cognitive Behavioral Therapy (CBT) group in a sample of obese~     individuals with respect to mid-term outcome.~   "
38210|NCT03066518|"~     Introduction: Patients with dementia may suffer from poor sleep quality. Disturbance in the~     metabolism melatonin may have a role in the pathogenesis of sleep-wake cycle alterations in~     dementia.~      Objective: To evaluate the efficacy of low dose exogenous melatonin in improving sleep~     quality.~      Design: A single-center randomized, double-blinded, placebo-controlled study carried out on~     outpatients with dementia and sleep alterations.~      Participants: The investigators calculated a 40 individuals aged 65 years or over with a~     diagnosis of mild-moderate dementia (Clinical Dementia Rating 1-2).~      Intervention: Patients were randomized to receive either 5 mg of melatonin or placebo every~     night for 8 weeks.~      Measurements: The primary outcome was sleep quality according to the Pittsburgh Sleep Quality~     Index (PSQI).~   "
38211|NCT03066505|"~     This pilot study is a randomized, double-blind, sham-controlled study designed to evaluate~     the efficacy of Magnetic EEG/ECG-Guided Resonance Therapy (MeRT) in college students with~     ADHD. A total of 40 subjects will be treated.~   "
38212|NCT03066492|"~     This randomized controlled trial examines the effects of a transitional care clinic for~     high-risk patients at an academic medical center who had no trusted medical home. The trial~     will provide the first reliable evaluation of the Northwestern Transitional Care Clinic /~     Follow Up Clinic's (NFC) impact on re-admissions, care coordination, and costs. This research~     will allow us to assess the value of the NFC and similar models of care for providing a more~     coordinated care approach that results in better treatment outcomes for urban poor~     populations.~      It is hypothesized that NFC patients will have fewer 90-day re-hospitalizations and are more~     likely to have a usual source of primary care 6 months after discharge.~   "
38213|NCT03066479|"~     This study is to evaluate a commercial tool on the market (Fitbit®) that also quantifies~     sleep. No one has studied how pediatric patients perform with it and how accurate it is in~     measuring their quality of sleep. This study will use the obstructive sleep apnea (OSA)~     questionnaire completed by parents and Fitbit® together and evaluate how they perform against~     the polysomnography (PSG).~   "
42269|NCT03013465|"~     The objectives of the study are 1) to determine the influence of daily consumption of~     well-cooked broccoli on plasma and urinary glucosinolate metabolites, and 2) to determine~     inflammatory marker changes consistent with decreased cancer risk.~   "
38214|NCT03066466|"~     Chronic Graft Versus Host Disease (GVHD) is one of the most challenging complications in long~     term survivors of allogeneic stem cell transplantation. As the number of allogeneic stem cell~     transplantations rises annually, the incidence of chronic GVHD rates have also increased due~     to a variety of factors including but not limited to increasing use of peripheral blood stem~     cell (PBSC) grafts, increasing age of both donors and recipients, and increased use of~     matched unrelated donors. One study showed much lower than traditional acute GHVD rate and~     chronic GHVD which is similar with historical rates when atorvastatin was administered~     prophylactically to both the donors as well as recipients of matched related allogeneic stem~     cell transplantation, lead to the interest in further examining the role of Atorvastatin in~     relation to the development of GVHD. The investigator hypothesize that the administration of~     atorvastatin in recipients of matched unrelated allogeneic stem cell transplantation, a group~     with known higher incidence of chronic GHVD, would be a safe and effective method to reduce~     the incidence of chronic GVHD. Matched related allogeneic stem cell transplantation~     recipients will not be included in this study due to their significantly lower GVHD rates.~     The definition and monitoring of our primary endpoint of GVHD is well established in clinical~     trials in allogeneic stem cell transplantations and the investiagor will utilize the National~     Institutes of Health (NIH) Staging System for the diagnosis and severity assessment of~     chronic GVHD as well the recommendations from the NIH Consensus Conference for the conduct of~     clinical trials in chronic GVHD.~      Several secondary endpoints will be examined as defined below and include standard~     complementary data in the examination of clinical trials in chronic GVHD again as laid out by~     the NIH Consensus Conference for conduct of clinical trials in chronic GHVD.~   "
38215|NCT03066453|"~     The aim of this study is to investigate the efficacy of antibiotic therapy with any~     antibiotic (IV) and IV (Nebcin®) tobramycin for 5 days followed by Solution for nebuliser~     inhalation (Tobi®) for 9 days and antibiotic cures using 14 days of tobramycin IV. In the~     case of positive results, the reduction of the duration of IV treatment of tobramycin from 14~     days to 5 days would limit the risk of toxicity.~   "
38216|NCT03066440|"~     Objectives: Intravenous (IV) fluid administration is a fundamental component of diabetic~     ketoacidosis (DKA) treatment. Normal saline (NS), the most common IV fluid used in DKA~     management, contains more chloride than human blood. Excessive amounts of chloride have been~     shown to cause a detrimental metabolic acidosis. Other IV fluids have more physiologic~     chloride levels, such as lactated ringers (LR). This study will compare the rates of~     hyperchloremic metabolic acidosis in children treated with NS to those treated with LR to~     determine the effect on overall length of acidosis and length of stay in the hospital or~     intensive care unit.~      Design: Single-center, double blinded, randomized controlled trial.~      Subjects: Children aged 0 to 18 years who present with diabetic ketoacidosis and require~     pediatric intensive care unit admission. Patients with evidence of shock, multi-organ failure~     or clinically significant cerebral edema will be excluded. The projected study population~     will be 104 patients, 52 in each arm.~      Interventions: Patients will be enrolled within 1 hour of presentation to the emergency room~     or pediatric intensive care unit if transferred directly from another facility. They will be~     randomized to receive intravenous fluids containing 0.9% saline or lactated ringers. All~     patients will be treated using the institutional DKA protocol with the content of the~     intravenous fluids being the only difference in treatment between arms. Study intervention~     lasts until the end of the acute management of DKA.~      Planned measurements and study outcomes: The primary study outcome will be duration of~     metabolic acidosis. Resolution of metabolic acidosis will be defined in three ways: 1.~     Normalization of the ketosis; 2. Normalization of the serum pH; 3. Normalization of the serum~     bicarbonate level. Secondary outcomes will include length of stay in the pediatric intensive~     care unit and length of stay in the hospital. All outcomes will be correlated with the~     overall chloride load given via intravenous fluids during DKA management. Regression~     modelling will control for any baseline differences between the groups in regards to severity~     of DKA, and if newly diagnosed or poorly controlled diabetes mellitus.~   "
38217|NCT03066427|"~     The therapeutic scenario of metastatic renal cancer is undergoing a new revolution with the~     appearance of a novel therapeutic strategy after the antiangiogenic treatments, that is the~     immunotherapy, in addition to the approval of new active drugs in the following lines of~     treatment.~      There are currently two phase III trials in the first line of treatment in metastatic renal~     cancer that include different combinations of treatment based on immunotherapy. If results of~     these studies were positive, the therapeutic algorithm would be modified so that the~     remaining drugs would have to be repositioned within the therapeutic decision scheme.~      Sunitinib has previously demonstrated its benefit in patients who had failed to prior~     treatment with cytokines, so it is likely to continue to be effective in patients who have~     become resistant to treatment with new drugs based on immune checkpoint blockade.~      This phase II study is developed to evaluate the activity of sunitinib after treatment with~     immunotherapy-based regimens that are currently being developed within phase III clinical~     trials.~   "
38218|NCT03066414|"~     OBJECTIVES: To investigate whether respiratory variations of the inferior vena cava (ΔIVC)~     and internal jugular vein (ΔIJV) diameters during standardized breathing (ΔIVCST and ΔIJVST)~     increase after a therapeutic bleeding in spontaneously breathing and non-obese patients with~     genetic hemochromatosis.~      DESIGN: Prospective, monocentric study in the EFS Nord-de-France blood center.~      PATIENTS: Non-obese patients with genetic hemochromatosis undergoing a therapeutic bleeding.~      INTERVENTIONS: Ultrasound measures and collected clinical parameters before and after a~     therapeutic bleeding, during a standardized respiratory maneuver.~      MAIN OUTCOME AND MEASURES: The primary endpoint was the ΔIVCST change induced by a 300 to~     500ml therapeutic bleeding. It measured the minimal and maximal IVC and IJV diameters during~     a standardized respiratory maneuver. ΔIVCST and ΔIJVST were calculated as follows: [(maximal~     diameter - minimal diameter)/maximal diameter].100.~   "
38219|NCT03066401|"~     OBJECTIVES: To investigate whether respiratory variations of the inferior vena cava (ΔIVC)~     and internal jugular vein (ΔIJV) diameters during standardized breathing (ΔIVCST and ΔIJVST)~     increase after a therapeutic bleeding in spontaneously breathing and obese patients with~     dysmetabolic hyperferricemia.~      DESIGN: Prospective, monocentric study in the EFS Nord-de-France blood center.~      PATIENTS: Obese patients with dysmetabolic hyperferricemia undergoing a therapeutic bleeding.~      INTERVENTIONS: The investigators performed ultrasound measures and collected clinical~     parameters before and after a therapeutic bleeding, during a standardized respiratory~     maneuver.~      MAIN OUTCOME AND MEASURES: The primary endpoint was the ΔIVCST change induced by a 300 to~     500ml therapeutic bleeding. The investigators measured the minimal and maximal IVC and IJV~     diameters during a standardized respiratory maneuver. ΔIVCST and ΔIJVST were calculated as~     follows: [(maximal diameter - minimal diameter)/maximal diameter].100.~   "
38227|NCT03066297|"~     The investigatros hypothesized that selection of surgical procedure according to the~     pre-defined institutional decision-making algorithm will not compromise the treatment~     outcomes including overall survival and disease-free survival in participants with clinical~     stage IA non-small cell lung cancer.~      The purpose of this study is to determine the outcome of participants with clinical stage IA~     NSCLC treated by 3 types of surgical resection (wide wedge resection, segmentectomy, or~     lobectomy) according to the institutional decision-making algorithm~      The investigators are planning to enroll 1,000 participants who meet the pre-defined~     eligibility criteria over 5 years.~   "
38364|NCT03064503|"~     In normal ageing, the impact of myocardial fibrosis on myocardial function is unclear as~     diastolic function is reported to change according to age. The objective is to explore the~     relationship between myocardial function changes, with local (T1 and diffusion) fibrosis~     measures with Magnetic Resonance Imaging (MRI) as well as global measures of fibrosis (skin~     auto-fluorescence and collagen blood-biomarkers).~   "
38220|NCT03066388|"~     It has been well established that only 40 to 60% of the patients hospitalized for~     inflammatory response syndrome (SIRS) positively respond to volume expansion (VE). The fluid~     responsiveness is usually estimated by assessing VE-induced change in stroke volume (SV). To~     guide prescriptions and possibly avoid deleterious effects of inappropriate VE, several~     clinical studies demonstrated that invasive dynamic indices based on heart-lung interactions~     permit an accurate prediction of the hemodynamic effects induced by VE.~      Mechanical ventilation induces cyclic changes in intrathoracic and transpulmonary pressures~     that transiently affect venous return, right and left ventricular preload, resulting in~     pronounced cyclic changes in SV in preload-dependent, but not in preload-independent~     patients. These cyclic changes in SV can be evaluated by the cyclic changes in arterial pulse~     pressure. Several studies have shown that pulse pressure variation is able to predict fluid~     responsiveness in patients in the operating room and intensive care unit (ICU).~      However, this technique requires percutaneous arterial catheterization, which is associated~     with several rare but serious complications (thrombosis, infections, pseudoaneurysm,hematoma,~     and bleeding).~      A method for assessing noninvasive arterial blood pressure using an electropneumatic control~     loop was introduced by Penaz in 1973. Briefly, the blood volume in a finger is measured and~     kept constant by applying corresponding external pressure. The continuously changing external~     pressure needed to keep the volume constant directly corresponds to the arterial pressure~     and, therefore can be used as continuous measurement of arterial blood pressure. Numerous~     studies evaluating the accuracy of this technology, e.g., Finapres™ (Ohmeda Monitoring~     Systems, Englewood, CO), and more recently of the Infinity CNAP™ SmartPod (Dräger Medical AG~     & Co.KG, Lübeck, Germany).~      The basic operating principle of the CNAP™ is similar to the Finapres™, but CNAP™ uses~     multiple control loops. It has recently been shown that CNAP provides real-time estimates of~     mean arterial blood pressure (MAP) comparable with those measured by an invasive~     intraarterial catheter system during general anaesthesia.~      The accuracy of the measures and the respiratory variations in pulse pressure obtained with~     the CNAP system have not yet been studied in ICU.~   "
38221|NCT03066375|"~     Objectives: To investigate whether respiratory variations of inferior vena cava diameters~     (cIVC) predict fluid responsiveness in spontaneously breathing patients with septic acute~     circulatory failure and irregular heartbeats.~      Design: Prospective, bicentric study, intensive care units.~      Patients and measures: Spontaneously breathing patients with sepsis and clinical signs of~     acute circulatory failure are included. A positive response to fluid loading (FL) is defined~     as an increase of the stroke volume (SV) >10%. The investigators measured the minimum~     inspiratory and maximum expiratory diameters of the IVC (idIVC and edIVC) during standardized~     (st) and unstandardized (ns) breathing. The investigators calculated cIVCst and cIVCns before~     a 500ml-colloid FL.~   "
38222|NCT03066362|"~     Hypovolemia and acute circulatory failure affects more than 60% of patients hospitalized in~     intensive care or resuscitation. The volume expansion (VE) by fluid replacement therapy is~     the first treatment improve circulatory function. However, too much VE can be harmful. So,~     the use of dynamic predictive indicators of fluid responsiveness is recommended in patients~     with sepsis.In patients with spontaneous ventilation, few studies have evaluated these~     parameters. In mechanical ventilation, indices based on the respiratory variation of the~     diameters of vena cava have been studied and validated to predict the response to VE. However~     there is no similar study in spontaneously breathing patients without ventilatory support.~     The investigators hypothesize that the respiratory variations in the IVC diameters and~     femoral artery flow during standardized respiratory cycles are predictive factors of fluid~     responsiveness in spontaneously breathing patients with sepsis, acute circulatory failure,~     and regular cardiac rhythm.~   "
38223|NCT03066349|"~     Patients who undergo in vitro fertilization with or without intracytoplasmic sperm injection~     (IVF / ICSI) often experience an impact on their quality of life and emotional maladjustment~     to treatment and outcome. Multiple contributors to this negative impact have been identified,~     including interference with professional activities, expenses related to fertility treatment~     and hormonal side effects. In-vitro maturation (IVM) of human oocytes obtained from minimally~     stimulated or unstimulated ovaries offers a more patient friendly treatment option than the~     conventional ovarian stimulation protocols for Assisted Reproductive Technology (ART)~     treatment. Historically, IVM has been offered to women with increased ovarian response~     (so-called high responders), typically women with polycystic ovaries (PCO/PCOS), who are at~     increased risk for ovarian hyperstimulation syndrome (OHSS) if conventional ART protocols are~     used. IVM treatment programs are characterised by a minimal administration of fertility~     hormones, are less disruptive to patients' daily life through a reduced need for hormonal and~     ultrasound monitoring, avoid a range of minor and major complications because of the reduced~     hormonal burden of this procedure, and aim to reduce the total cost for of infertility~     treatment.~      To facilitate the application of IVM as a treatment that can potentially improve the overall~     patient experience, a study comparing the psychological impact of a conventional ovarian~     stimulation protocol versus an IVM protocol will be conducted; furthermore, a study~     investigating the differences in quality of life between the two subgroups will also be~     performed.~      Socio-demographic data, medical characteristics and the following questionnaires will be~     collected: Specific questions for patients with fertility problems (FertiQol); Hospital~     Anxiety and Depression Scale (HAD) and an instrument to measure side effects designed by the~     research group. The study group (IVF patients and IVM patients) will be evaluated at three~     predefined time points: at intake, after oocyte collection and when the outcome after the~     first embryo transfer is known.~      Descriptive analysis, intergroup comparisons and explanatory/predictive model of the~     dependent variables (quality of life, emotional adjustment) will be performed.~   "
38224|NCT03066336|"~     The purpose of this study is to determine whether low level laser therapy (LLLT) using the~     Erchonia LunulaLaser device is effective in clearing toenails with onychomycosis.~   "
38225|NCT03066323|"~     This study is designed as a randomized, single blind (data evaluation), placebo controlled,~     full cross-over study and conducted in 166 (including 10% drop out) males and females, aged ≥~     18 and ≤ 65 and waist circumference of >80 cm for women and >94 cm for men (indicating~     increased risk of metabolic complications (WHO)) and having a sedentary lifestyle. Subjects~     will receive rice with a tea extract and rice without a tea extract.~      There will be three visits to the test facility: one screening visit and two intervention~     visits. During the intervention visits venous blood samples will be collected for the~     analysis of plasma glucose (t = -30m, -5m, 15m, 30m, 45m, 1h, 1h 30m, 2h and 3h, relative to~     the start of rice consumption ) and serum insulin (t = -5m, 30m, 1h, 2h and 3h).~      Between the two intervention visits subjects have an interval of one week. This interval is~     required to minimize subject discomfort from repeated blood sampling.~   "
38226|NCT03066310|"~     DNA biomarkers in urine are important diagnostic and prognostic indicators for bladder~     cancer. Many genetic alterations have been identified in the urinary DNA. However, not all~     bladder tumors harbor mutations in the most commonly altered oncogenes. Thus, to reach~     satisfactory sensitivity and specificity a new diagnostic test should include multiple~     biomarkers. The investigators will conduct a prospective evaluation of a panel of mutations~     in urine-DNA test for the detection of urothelial bladder carcinoma in patients with gross~     hematuria for cystoscope.~   "
38228|NCT03066284|"~     Using qualitative method; a qualitative case study using semi-structured interviews to~     explore patients' experiences. Study population of insulin pump patients aged 11-18 years old~     will be recruited from pediatrics with T1D at Dasman Diabetes Institute; who started using~     CSII at least one year ago and their parents. Semi-structured interviews will be recorded and~     then transcribed word by word. Data analysis will be performed using an inductive thematic~     approach.~   "
38230|NCT03066258|"~     Excessive vascular endothelial growth factor (VEGF) plays a key part in promoting~     neovascularization and edema in neovascular (wet) age-related macular degeneration (nAMD).~     VEGF inhibitors (anti-VEGF), including ranibizumab (LUCENTIS®, Genentech) and aflibercept~     (EYLEA®, Regeneron), have been shown to be safe and effective for treating nAMD and have~     demonstrated improvement in vision. However, anti-VEGF therapy is administered frequently via~     intravitreal injection and can be a significant burden to the patients. RGX-314 is a~     recombinant adeno-associated virus (AAV) gene therapy vector carrying a coding sequence for a~     soluble anti-VEGF protein. The long-term, stable delivery of this therapeutic protein~     following a 1 time gene therapy treatment for nAMD could potentially reduce the treatment~     burden of currently available therapies while maintaining vision with a favorable~     benefit:risk profile.~   "
38231|NCT03066245|"~     Patients qualified for this study are those diagnosed with ABCs and failed to be treated with~     other forms of classical therapies. In which, these patients will be engrafted with~     biodegradable scaffolds seeded with Mesenchymal Stem Cells (MSCs) supplemented with Platelet~     lysate.~   "
38232|NCT03066232|"~     Study the prevalence of delirium among old persons with home-nursing care living in the~     community. By recruiting the persons in a stable phase, the investigators wish to study the~     influence of an episode of delirium upon further cognitive and physical function.~   "
38233|NCT03066219|"~     The objective of this study is to compare the safety and efficacy of BRM421 Ophthalmic~     Solution to placebo for the treatment of the signs and symptoms of dry eye.~   "
38234|NCT03066206|"~     The goal of this clinical research study is to learn if poziotinib can help to control~     EGFR-positive non-small cell lung cancer (NSCLC) that is locally advanced or metastatic (has~     spread). EGFR-positive NSCLC means that there is a mutation (a type of genetic change) on the~     EGFR gene.~      The safety of poziotinib will also be studied.~      This is an investigational study. Poziotinib is not FDA approved or commercially available.~     It is being used for research purposes only. The study doctor can explain how the study drug~     is designed to work.~      Up to 80 participants will be enrolled in this study. All will take part at MD Anderson.~   "
38235|NCT03066193|"~     This is an investigator-initiated proof of concept study with the purpose to examine the~     safety, tolerability and feasibility of Dronabinol (synthetic Δ9-THC) and PEA for the~     treatment of adults with Tourette syndrome.~   "
38236|NCT03066180|"~     This is a prospective, pilot clinical study involving two study groups. This study is~     designed to demonstrate that the study treatment meets primary efficacy and safety endpoints.~     The treatment involves radiofrequency treatment to address symptoms of stress urinary~     incontinence.~      After receiving the study treatment, subjects will be followed out to 12 months~     post-treatment. At the Screening Visit, and at each designated follow-up timepoint, subjects~     will be asked to complete a variety of questionnaires, provide a patient diary, and undergo~     an objective assessment for urine loss.~   "
38237|NCT03066167|"~     This study validates 3 well known dysphagia scores for dysphagia due to malignancies of the~     oesophagus and gastro-oesophageal junction and to the Swedish language.~   "
38238|NCT03066154|"~     The optimal treatment for HRPC patients has not yet been established. Recent trials suggest a~     benefit from early treatment with docetaxel in the castration-sensitive setting, with an~     improvement in failure free survival in high risk and metastatic patients and increase in~     overall survival in the metastatic hormone-sensitive group. In these recent randomized~     controlled trials, patients were treated with hormonal therapy and radiotherapy and adjuvant~     docetaxel, assuming that early systemic treatment for high risk or metastatic disease could~     delay progression in patients with aggressive primary tumor characteristics.~      With the fact that docetaxel is a known radiosensitizer, combined modality treatment with~     docetaxel during the radiotherapy could also lead to better local control and reduction of~     local recurrence. Several phase I and II studies have been done in HRPC patients, to evaluate~     the combination of high dose radiotherapy and concurrent weekly infusions with docetaxel.~      Oral administration of docetaxel has many advantages above intravenously administered drugs~     for patients. Besides the higher patient convenience, possibly longer treatment duration can~     be achieved due to better safety. Frequently occurring toxicities of intravenously~     administered docetaxel, such as neutropenia, hypersensitivity reactions and peripheral~     polyneuropathy have rarely been observed with the oral docetaxel formulation ModraDoc006/r.~      The primary aim of the N15DOP study is to determine the maximum tolerable dose (MTD) of~     ModraDoc006/r when given in a weekly bidaily schedule in combined modality with high dose~     intensity radiotherapy and hormonal therapy in castration-sensitive prostate cancer patients~     with high risk disease, including positive lymph nodes.~   "
38239|NCT03066141|"~     It is widely accepted that coronary artery disease (CAD) is related to a high mortality. It~     is predicted that an increase of approximately 21.3 million cardiovascular events and 7.7~     million cardiovascular deaths over 2010 to 2030 in China.1 Male sex, diabetes mellitus,~     hypertension, hypercholesterolemia, obesity and smoking are all traditionally considered as~     risk factors for CAD. In recent decades, tremendous progress toward the prevention and~     treatment of traditional cardiovascular risk factors have helped decrease the morbidity and~     mortality from CAD, but the condition remains a major public health challenge worldwide.~     Looking into the other potential risk factors (OSA) for CAD, it may help to develop~     additional preventative strategies and further reduce the incidence and mortality of CAD.~   "
38249|NCT03065998|"~     The aim of this study is examining the combination of two FDA approved drugs, Opipramol and~     baclofen, which may increase rehabilitation from psychoactive substances. Previous studies~     have indicated a connection of sigma-1 receptor to cocaine abuse and raised the possibility~     that these receptors as mediators of drug craving . However previous studies showed partial~     efficacy with no significant relapse in relapse rates. The same is true for the use of~     GABAb-1 receptor antagonist. Opipramol is a selective agonist for sigma-1 receptor. It is~     clinically used as an antidepressant and anxiolytic agent. Moreover, previous open and~     controlled trials indicated that the GABAb-1 antagonist baclofen partial efficacy in~     suppressing withdrawal symptoms in alcohol addicts and cocaine. Our studies in an animal~     model for addiction have shown a significant effect of the combine treatment of the indicated~     medications both in decreasing relapse and increase of -number of respondents.~   "
42270|NCT03013452|"~     In this study, investigating two modes of chest physiotherapy on lung clearance index (LCI),~     50 patients with bronchiectasis will be randomized to either oPEP or autogenic drainage.~   "
38240|NCT03066128|"~     Effective management of patients on antiretroviral therapy (ART) is essential to improve~     clinical outcomes and prevent HIV transmission, but monitoring life-long ART for over 15~     million HIV-infected people has become a challenge, particularly in low- and middle-income~     countries (LMICs). As programs continue to focus on identifying HIV-infected people and~     starting ART at higher CD4 thresholds, HIV providers have been overburdened, which has~     resulted in falling retention rates. As ART coverage scales up to include millions more~     people, additional strain will be placed on HIV clinicians and laboratories to manage stable~     patients on chronic ART. Implementing point-of-care HIV VL testing to enable task shifting to~     nurses for chronic HIV care may help mitigate these burdens. Point-of-care Viral Load (VL)~     testing is intended to differentiate patients who are potentially failing on their ART, so~     that they can be referred to the next level of care for possible ART regiment change, from~     patients who are virally suppressed on ART and can be managed by nurses. The investigator's~     scientific objective is to test the clinical equivalence and reduced cost of implementing a~     model for chronic HIV care that uses a point-of-care HIV VL assay to enable streamlined care~     and task shifting among healthcare workers at an urban clinic in South Africa. The central~     hypothesis is that rapid HIV VL testing, implemented by nurses, is an effective and~     cost-efficient strategy for management of chronic HIV infection in the majority of patients,~     thereby allowing more resources to be directed at the minority of patients who need greater~     attention. This work is innovative because it uses a randomized evaluation of an~     implementation model that combines a novel diagnostic point-of-care test with streamlined~     care and task shifting among healthcare workers compared to standard of care for chronic HIV~     care in a resource-limited setting. This randomized trial will then form the basis of a~     larger, multicountry proposal to demonstrate the clinical equivalence and cost-effectiveness~     of implementing an integrated point-of-care HIV VL testing and streamlined care model for~     chronic HIV care in LMICs. If nurses using clinic-based HIV VL testing are cost-effective for~     achieving both viral suppression and retention in care among patients on ART, then~     implementation of this chronic HIV care model would alleviate the strain on existing HIV~     providers and laboratories in LMICs.~   "
38241|NCT03066115|"~     Elucidating cerebrovascular control mechanisms during physiologic stress may help identify~     novel therapeutic targets aimed at preventing or reducing the impact of cerebrovascular~     disease. The physiological stressors of hypoxia and hypercapnia will be utilized to elicit~     increases in cerebral blood flow (CBF), and intravenously infused drugs will allow for the~     testing of potential mechanisms of cerebrovascular control. Specifically, the contributions~     of nitric oxide synthase (NOS), cyclooxygenase (COX), and reactive oxygen species (ROS) to~     hypoxic and hypercapnic increases in CBF will be examined. The concept that these mechanisms~     interact in a compensatory fashion to ensure adequate CBF during both hypoxia and hypercapnia~     will also be tested.~      ~25 young, healthy men and women will be tested at rest and during hypoxia and hypercapnia.~     Subjects will participate in two randomized, counterbalanced study visits under the following~     conditions: inhibition of NOS, NOS-COX, and NOS-COX-ROS or inhibition of COX, COX-NOS,~     COX-NOS-ROS. During hypoxia, arterial oxygen saturation will be lowered to 80% and end-tidal~     carbon dioxide will be maintained at basal levels. During hypercapnia arterial carbon dioxide~     will be increased ~10 mmHg above basal levels and arterial oxygen saturation will be~     maintained. Blood flow velocity will be measured with transcranial Doppler ultrasound in the~     anterior (middle cerebral artery; MCA) and posterior (basilar artery; BA) circulations as a~     surrogate for CBF.~      It is hypothesized that both NOS and COX independently contribute to hypoxic and hypercapnic~     vasodilation in the MCA and BA, combined NOS-COX contribute to hypoxic and hypercapnic~     vasodilation in MCA and BA to a greater extent than either NOS or COX alone, and NOS-COX-ROS~     contribute to hypoxic and hypercapnic vasodilation in the MCA and BA to a greater extent than~     NOS-COX.~   "
38242|NCT03066102|"~     The aims of this study are to investigate the effects of scapular muscle fatigue on scapular~     joint position sense and neuromuscular performance (scapular muscle strength, the kinematics~     data and muscle activity of shoulder during scaption (arm elevation in the scapular plane)).~     The investigators hypothesize that scapular muscle fatigue would increase scapular reposition~     error and affect neuromuscular performance of the scapular during scaption.~   "
38243|NCT03066089|"~     This study is an open label, two armed trial evaluating the safety and efficacy of Fenfuro~     capsule twice daily for 90 days in 100 patients with type 2 diabetes that will be conducted~     in single center in India. The primary outcome measures will be the determination of decrease~     in plasma glucose levels from baseline to last visit. The secondary outcome will be the~     determination of safety of Fenfuro capsule in type 2 diabetic subjects.~   "
38244|NCT03066076|"~     Introduction: Graves disease (GD) is characterized by thyrotoxicosis and goiter, arising~     through circulating autoantibodies that bind to and stimulate the thyroid hormone receptor~     (TSHR). Graves' ophthalmopathy (GO) is characterized by inflammation, expansion of the~     extraocular muscles and an increase in retroorbital fat. There are currently three forms of~     therapies offered: anti-thyroid drugs (ATD) (thionamides), radioactive iodine (RAI) and total~     thyroidectomy (Tx). There is currently no consensus on the treatment of Grave's disease and~     GO.~      Objective: To examine the difference in the outcome of GO in patients with moderate-to-severe~     GO, who receive Tx versus further ATD after suffering their first relapse of GO or in which~     GO stays the same following the initial decrease in ATD therapy after 6 months.~      Methods: This prospective randomized clinical trial with observer blinded analysis will~     analyze 60 patients with moderate-to-severe GO who receive Tx versus ATD without surgery.~     Main outcome variables include: muscle index measurements via ultrasound and thyroid antibody~     levels. Additional outcome variables include: CAScore/NOSPECS score, superonasal index~     measurements via ultrasound and quality of life score.~   "
38245|NCT03066050|"~     This study is a continuation of two previous studies --- the Severe Ischemic Mitral~     Regurgitation (SMR) Trial (NCT00807040) and the Moderate Ischemic Mitral regurgitation (MMR)~     Trial (NCT00806988) --- to learn more about patients' health 5-10 years after their mitral~     valve surgeries. The investigators will collect long-term health information on SMR and MMR~     trial participants using electronic medical records, patient and/or family input, public~     records, and healthcare- and vital status-related databases.~   "
38246|NCT03066037|"~     There is a significant debate whether local infiltration techniques may be a method to treat~     complicated chronic pain syndromes, e.g. refractory headache. Until now there is a lack of~     evidence regarding efficacy of this treatment especially in long term follow up. Similarly,~     indication and management are under debate. Aim of this trial is to analyse pain scores~     during first treatment with anaesthesiological infiltration series.~   "
38247|NCT03066024|"~     As part of the clinical routine of the Department of Anesthesiology and Intensive Care~     Medicine CVK/CCM in the Charité - University Medicine Berlin intraoperative~     electroencephalography data and clinical routine data are recorded and evaluated in surgical~     children and adolescents according to different age groups.~   "
38248|NCT03066011|"~     The purpose of this study is to describe representative real-world patterns of care for the~     management of invasive fungal infections (IFIs), including invasive mold infection (IMI).~     Specifically, the study goals are to examine real world patient characteristics and treatment~     patterns, associated healthcare resource utilization, and outcomes associated with use of~     mold-active triazoles (MATs) to treat invasive fungal infections (IFIs).~   "
38250|NCT03065985|"~     This study will assess if endoscopic ultrasound radiofrequency application in patients with~     inoperable pancreatic cancer and chemotherapy confers survival benefit when compared to~     patients receiving best medical care and chemotherapy .~   "
40427|NCT03037554|"~     A home-based, sham-controlled, double-blind, crossover study evaluating the effects of~     wearing sleepwear with lateralized thermal characteristics on subjective and objective sleep~     measures, proximal skin temperature, and sternal skin moisture in menopausal women~     complaining of sleep disturbance and vasomotor symptoms.~   "
38253|NCT03065946|"~     Unconscious survivors of cardiac arrest who are treated with intravenous therapeutic~     hypothermia for 24 hours will be assessed after 12 hours for appropriateness to be woken~     early and extubated whilst continuing to receive therapeutic hypothermia. Sedation will be~     reduced/stopped at 12 hours to enable a comprehensive neurological assessment utilising a~     multimodal approach.~      Providing the patient is clinically stable with no adverse neurological signs the patient~     will be extubated. Patients who remain unconscious will be reviewed 6 hourly for neurological~     recovery and their suitability to be extubated in line with standard practice.~   "
38254|NCT03065933|"~     The investigators plan to to study an extended-release form of clonidine, which the~     investigators hope will be even better tolerated than the immediate-release form, as an~     antimanic agent. Subjects will receive an extended-release form of clonidine in addition to~     their usual medication regimen on the second day of this three-day study. Rating scales, a~     record of sleep, and a questionnaire of adverse effects will be recorded on each of the 3~     days. Any medication changes made by the attending psychiatrist and prns administered will be~     recorded throughout the study.~   "
38255|NCT03065920|"~     This study is a prospective observational multicentre cohort study of asthma patients in~     Eastern Africa whose objectives will be; The primary objective of this project is to identify~     and characterize severe asthma in Eastern Africa in order to understand its demographic,~     clinical, physiologic, pathologic, genomic and immunologic determinants.~      Secondary objective(s) are; Compare the annual healthcare utilisation (HCU) (emergency room~     visits, hospitalization including admission to critical care units and unscheduled outpatient~     clinic or office visits), exacerbation, quality of life and mortality rates of severe and~     not- severe asthma patients Determine the factors associated with the asthma HCU events,~     quality of life, exacerbations and mortality The study will enroll 1676 patients aged between~     12 and 70 years and follow up each patient for up to one year.~   "
38256|NCT03065907|"~     The purpose of this research is to collect preliminary data in preparation for conducting a~     randomized clinical trial to determine the relative effectiveness of vision rehabilitation in~     improving overall visual ability (primary aim) and reducing depression (secondary aim) in~     patients receiving anti-VEGF therapy for neovascular age-related macular degeneration~     integrated over time.~   "
38257|NCT03065894|"~     This study aims to examine patient outcomes following risk stratification for low back pain~     in Family Medicine combined with either matched physical therapy (PT - i.e.,~     stratified-specific PT) treatments or current treatment in primary care across The University~     of Vermont Health Network.~   "
38258|NCT03065881|"~     The primary objective of this study is to collect electroretinogram ERG measurements from~     visually normal and abnormal subjects using the FDA cleared RETeval device (K142567). Data~     from the visually normal subjects will be used to create reference intervals for the device.~     Secondary objectives of the study are to provide ERG waveforms representative of disease~     states encountered and to analyze how well an ERG detects the various disease states~     encountered.~   "
38259|NCT03065868|"~     Evaluation of the effect of H. pylori eradication on regression of H. pylori-related gastric~     polyp (Ranomized controlled trial)~        1. Study design: open labeled RCT~        2. Study group H. pylori eradication group (N=30), non-eradication group (N=30)~        3. Treatment plan~             1. Baseline EGD~                : 0.5-1cm sized polyp - bx & CLO test (antrum & body)~                ==> if H. pylori positive and eligible patients, randomization~             2. Triple therapy~             3. UBT (4week after eradication)~             4. Follow-up EGD: gross finding, CLO test~        4. Evaluation of polyp regression~             1. disappear~             2. regression over 50% (size, number)~             3. no change or increase (size, number)~   "
38260|NCT03065855|"~     Traditionally these catheters are retained for 7 days, because a higher incidence of urinary~     retention is related to early removal of the urinary catheter. However, recently Enhanced~     Recovery After Surgery presents that urinary catheters placed via the urethra can be~     withdrawn 48 hours after colon/rectal surgery in patients receiving epidural pain relief，but~     there is no clear data on the incidence of urine retention.Longer retaining time of urethral~     catheter would induce the urinary tract infection while early removal of urethral catheter is~     considered to develop acute retention of urine due to lack of sensation when the bladder is~     full. Taking the comfort and mobility for faster rehabilitation of patients into account, the~     investigators aim at obtain the optimal removal time of urinary catheter after after~     laparoscopic anterior resection of the rectum~   "
38261|NCT03065842|"~     In many low-income countries, unsafe abortion is recognized as a leading cause of maternal~     morbidity and mortality. Social stigma surrounding abortion and contraceptive use plays a~     critical role in the social, medical, and legal marginalization of abortion and contraceptive~     services. Though this stigma is pervasive and threatens women's health, it is not well~     understood how it can be reduced. The Stigmatizing Attitudes, Beliefs and Actions Scale~     (SABAS) was designed in 2013, to measure abortion stigma at individual and community level.~     Objective: I) to conceptualize abortion stigma among; health care providers, secondary school~     teachers and students, and II) to determine if a school based intervention targeting stigma~     specifically faced by girls when accessing abortion and contraceptive services, compared to~     usual standards, will decrease related stigma and increase contraceptive use among students,~     who are sexually active. Design, Setting, Participants: I) Focus group discussions (FGD) with~     service providers at YFC (n=12), secondary school teachers (n=16) and secondary school~     students (n=20), and II) a quasi-experimental pre- and post-intervention study, targeting 800~     secondary school students (14-20 y), in Kisumu, Kenya. Two schools will be cluster-randomised~     into one interventions unit (n=400 students) and one control unit (n=400 students), according~     to the study site, size and academic standards of school. The region is chosen because of its~     low rate of contraceptive use and high rate of unsafe abortion. Standard deviation is the~     measure of dispersion or variability in the data. The sample size of 400 is based on a~     previous study and will give a power of 80% to detect differences (95% Cl) between the two~     groups (sample size and power will be re-calculated after baseline and take into account~     variability (SD) in the data). Intervention: An abortion- and contraceptive-use stigma~     reduction intervention (1-month program), capturing negative stereotypes about women that are~     associated with abortion and contraceptive use. Main Outcome (re-calculated after baseline):~     Abortion-stigma reduction. Secondary outcome: Contraceptive-use stigma reduction. Measured at~     baseline (pre-test), and post-test at 1- and 12-months, by using the validated SABA-scale.~     Analyses: Qualitative content analysis and repeated measures, ANOVA.~      Funded by: The Swedish Research Council for Health, Working Life and Welfare 2015-01194, and~     The Swedish Research Council 2016-05670~   "
38316|NCT03065127|"~     Freezing of gait (FOG) is arguably one of the most debilitating motor symptoms experienced by~     individuals with Parkinson's disease (PD). FOG may be caused by an overload of cognitive,~     limbic, and sensorimotor system activity in the basal ganglia. Therefore, the purpose of this~     study is to evaluate cognitive, limbic, and sensorimotor therapies in individuals with FOG.~     Participants in this study will undergo all three types of treatments in a randomized~     counterbalanced order. Each treatment will occur in 1 hour sessions, twice weekly for a~     period of 4 weeks.~   "
38262|NCT03065829|"~     For family members of chronically critically ill (CCI) patients, an ICU admission marks a~     significant milestone in the patient's illness trajectory that highlights the onset of end~     of-life issues and an abrupt need for family members to assume the caregiver role for the~     first time. Assuming the caregiver role can have devastating and longstanding health~     consequences for family members, which can impair their ability to sustain caregiving~     behaviors for a CCI patient. The unrelenting psychological distress perceived by caregivers~     of CCI patients is linked to significant reductions in their self-management and health~     outcomes.~      The purpose of this study is to evaluate a theoretically-derived Adaptive SenSor-Based~     Intervention for Caregiver Self-ManagemenT (ASSIST) intervention compared to an attention~     control condition for first time caregivers of CCI patients discharged to an extended care~     facility. One group will be exposed to the ASSIST intervention and will wear the sensor-based~     technology for 30 days and receive a daily dose of MMT. Biophysical sensor data (blood~     pressure, heart-rate variability, pedometry, and actigraphy) will be continuously acquired~     and analyzed using anomaly detection and machine learning techniques to vary the dose~     intensity (number of doses per day) of the two components of ASSIST adding a real-time,~     adaptive feature to promote caregiver self-management. The other group will wear the~     sensor-based technology for 30 days but will not receive the daily dose of MMT. The~     investigators will randomly assign participants to each group.~   "
38263|NCT03065816|"~     Primary Objective:~      Pharmacodynamics: assessment and comparison by gamma scintigraphy of the gastric retention of~     alginate rafts (raft performance) of Z0063 to the effect of Gaviscon Double Action Tablets,~     in healthy adult subjects.~      Secondary Objective:~      Safety: assessment of the clinical safety of Z0063 versus Gaviscon Double Action tablets, in~     healthy adult subjects.~   "
38264|NCT03065803|"~     Introduction and evaluation of a new technique for socket preservation involving internal~     expansion of the buccal plate of the extraction socket using internal flapless corticotomy~     and bone grafting the extraction socket with application of bioresorbable membrane~     biomaterials in comparison with the conventional guided bone regeneration technique for a~     conventional socket preservation method hoping to maintain or improve hard and soft tissue~     contour of the alveolar ridge post tooth extraction.~   "
38265|NCT03065790|"~     Adult patients with non-Hodgkin lymphoma who will be treated with lenalidomide will undergo~     FDG PET/CT scan as an early evaluation of response to therapy. Changes in FDG uptake will be~     correlated response and long term outcomes.~   "
38266|NCT03065777|"~     Assessment of postoperative pain after root canal treatment using different rotary systems.~   "
38267|NCT03065764|"~     After a screening phase of up to 42 days, eligible subjects will undergo two whole body~     immuno-PET scans with a non-therapeutic tracer dose (2 mg) of 89Zr-pembrolizumab; one with~     and one without a preceding cold therapeutic dose of pembrolizumab. For the first 3~     patients, PET scans will be obtained at 1, 72 and 120 hours post tracer injection to~     determine the optimal scan time point and to perform biodistribution measurements and~     dosimetry. All subsequent patients receive only 1 PET scan post-injection (i.e. two PET~     scans). The optimal time point is expected to be at day 5 post-injection. Pembrolizumab~     treatment will continue every three weeks until two years of therapy have been administered,~     disease progression, or unacceptable adverse event(s).~   "
38268|NCT03065751|"~     Sepsis is defined by the occurrence of a systemic inflammatory response syndrome (SIRS) in~     the context of infection. Unfortunately, its incidence appears to be rising, and the~     mortality of septic shock remains extraordinary high (> 60%). Death in sepsis arises from~     shock and multi organ dysfunction that are - at least in part - triggered by an inadequate~     response of the host's immune system to the infection. Given the injurious role of 1) this~     overwhelming immune response and 2) the consumption of protective plasmatic factors (e.g. vWF~     cleaving proteases, hemostatic factors etc.) while the disease is progressing the~     investigators hypothesize that early therapeutic plasma exchange (TPE) in the most severely~     ill individuals might improve hemodynamics, oxygenation and ultimately survival. This~     therapeutic strategy combines 2 major aspects in 1 procedure: 1. removal of harmful~     circulating molecules and 2. replacement of protective plasma proteins. The investigators~     designed the EXCHANGE trial to analyze in a randomized fashion the benefit of TPE as an~     add-on treatment to state of the art standard sepsis care. Only patients with early septic~     shock (< 12 hrs) and high catecholamine doses (noradrenaline > 0.4 ug/kg bodyweight/min) will~     be included. Those in the treatment group will receive 3 TPEs within three consecutive days.~     The primary outcome is 28-day all cause mortality. To show an assumed reduction from 60% to~     45% in the experimental group, a sample size of 173 patients per group has been calculated.~     The overall sample size is therefore n=346. The recruitment period is 3 years (+3 months~     observation) and will be performed in 11 national centers in Germany. Secondary endpoints~     (including hemodynamics, oxygenation, coagulation, and microcirculation) will be assessed on~     day 1, 2, 3 before and after TPE and on day 4, 5, 7 and 14.~      Project management and data monitoring will be organized by the Hanover Clinical Trial Center~     and biostatistics including a web-based randomization will be performed by the Institute of~     biometrics (Prof. Koch) at Hannover Medical School.~      The investigators hope to demonstrate a potential benefit of an additive treatment approach~     to improve the outcome of patients suffering from an under-recognized but deadly disease.~   "
38269|NCT03065738|"~     Effect Of Reduction Osteotomy On Gap Balancing During Total Knee Replacement For Severe Varus~     Deformity~   "
38270|NCT03065725|"~     The aim of this study is to examine if late FDG-PET/CT images after intravenous FDG injection~     has a higher sensitivity and specificity in detecting local lymph node metastases in patients~     with muscle invasive BC than FDG-PET/CT images 60 minutes after FDG injection. The latter~     procedure has been used routinely until now.~   "
38271|NCT03065712|"~     This study will formally address the hypothesis that FES-PET/CT measurement of ER expression~     predicts clinical benefit of first-line endocrine therapy in newly diagnosed ER+ metastatic~     breast cancer patients and establishes the repeatability of FES PET/CT.~   "
38272|NCT03065699|"~     The First-In-Man study is a multi-centre, randomised, controlled, study to generate data for~     the evaluation of safety and performance of DIALIVE Liver Dialysis Device in 24 evaluable~     patients with Acute on Chronic Liver Failure (ACLF) versus standard of care (SOC).~   "
38273|NCT03065686|"~     Despite significant progress made in identification on numerous genes and gene pathways~     critical for craniofacial development, several approaches, ie mutation screening of specific~     candidates, association studies and even genome-wide scans have largely failed to reveal the~     molecular basis of NS human clefting. Moreover, the efficiency of Whole Exome Sequencing~     -WES- was proven. The efficiency of WES was proven by the identification of the genes causing~     Freeman Sheldon and Miller's syndrome, followed by several others. In the Picardy region,~     management and follow-up of orofacial cleft patients are well-organised by a~     multidisciplinary team in the university hospital of Amiens. The investigators therefore~     decided to perform whole exome sequencing (WES) on precisely phenotyped non-syndromic CL/P~     patients followed in our center.~   "
38274|NCT03065673|"~     Purpose: This study will determine the effectiveness of the use of desensitivity gels prior~     in office bleaching on risk and intensity of tooth sensitivity caused by in-office bleaching~     using 35% hydrogen peroxide. Materials and Methods: Fifty patients will be selected for this~     triple-blind, randomized, cross-over, placebo-controlled clinical trial. 10 minutes prior to~     bleaching procedure, patients will receive the potassium oxalate 5% desensitivity gel and~     placebo application on vestibular surface. The whitening treatment with 35% hydrogen peroxide~     will be carried out in two sessions with a 7-day interval. Tooth sensitivity will be assessed~     before, during and 24 hours after the procedure using analog visual and verbal scales. Color~     alteration will be assessed by a Classical guide scale. Relative risk to sensitivity will be~     calculated and adjusted by session; while comparison of overall risk will performed by~     McNemar's test. Data on the sensitivity level for both scales and color shade will be~     subjected to the Friedman, Wilcoxon and Mann-Whitney tests, respectively (α = 0.05)~   "
38275|NCT03065660|"~     Miscarriage is the most common complication of pregnancy. As many as 15-25% of pregnancies~     end in miscarriage, and the number of miscarriages in England is estimated to be~     approximately 125,000 per year. Miscarriage often brings not only physical pain, bleeding and~     risks of infection, but also psychological impacts on women and their families. This study~     will focus on women whose pregnancy sac remains inside the womb (known as a missed~     miscarriage) and opt for medical management of their miscarriage up to 13+6 weeks of~     pregnancy. NICE currently recommends that a drug called misoprostol (a vaginal pessary or~     oral tablet that makes the womb contract) should be used in the medical treatment of~     miscarriage. However, there is evidence to suggest that combining this drug with mifepristone~     (an oral tablet that reduces pregnancy hormones) may be more effective in treating~     miscarriage. Therefore, to test this in a clinical trial, participants will be allocated at~     random to receive either mifepristone followed by misoprostol, or a dummy drug (placebo)~     followed by misoprostol. Neither the participants nor the researchers will know what~     allocation is decided, which is necessary to test the treatments fairly. The main outcome of~     interest will be whether miscarriage is complete within 7 days of randomisation. If~     miscarriage is not complete then further treatment (more tablets or surgery) will be offered.~     A number of other key outcomes, such as the need for an operation, will also be assessed. We~     will also study the views and experience of the participants regarding the tablet treatment.~      We anticipate that 710 women will be required to take part in the study to answer this~     question with confidence. We estimate that we would be able to recruit this many women in two~     years.~   "
38276|NCT03065647|"~     In the U.S. alone, over 300,000 people per year have sudden out-of-hospital cardiac arrest~     (OHCA), and less than 1 out of 10 survive. The current standard practice for treating OHCA is~     to perform cardiopulmonary resuscitation (CPR) and Advanced Cardiovascular Life Support~     (ACLS) at the scene until either the heart is restarted or resuscitation efforts are~     considered hopeless and discontinued. An alternative strategy for those with refractory OHCA~     is expedited transport with ongoing mechanical CPR to an Emergency Department capable of~     performing extracorporeal cardiopulmonary resuscitation (ECPR). The purpose of study is to~     test if this strategy is feasible and beneficial.~   "
38277|NCT03065634|"~     Based on a randomized controlled trial, the manualized group intervention Return to work and~     living healthy after head and neck cancer (RELIANCE) for head and neck cancer survivors will~     be tested against a non-manualized control intervention (social counseling) in order to~     evaluate the efficacy of the RELIANCE intervention compared to the control condition. The~     study design includes two phases, the initial study phase (pilot study) and the intervention~     study (RCT). The aim of the pilot study is to implement and ensure the necessary standardized~     procedures for the implementation of patient recruitment and interventions. In the randomized~     controlled trial, potential participants are assigned to the intervention group or to the~     control group.~   "
38278|NCT03065621|"~     This is an open-label, single arm, phase 2 trial that will include pre or post-menopausal~     female subjects, that have ER-positive, HER2-negative early breast cancer. Subject will~     receive 4 cycles of palbociclib 125 mg (each cycle of palbociclib consists of treatment from~     D1 to D21 followed by a week of rest) combined with endocrine therapy given continuously~     (each cycle of endocrine therapy consists of treatment from D1 to D28).~      The endocrine therapy will be determined according to the menopausal status of the subject~     evaluated at the study screening.~   "
38279|NCT03065608|"~     Temporomandibular joints dysfunction is a functional disorder concern with the abnormal~     functioning of the muscles of the stomatognathic system, temporomandibular joints involved in~     the dynamic movements of the jaw and surrounding structures.~      The aim of the study was to compare the level of C-reactive protein in patients with pain and~     painless form of temporomandibular joints dysfunction.~   "
38280|NCT03065595|"~     This study is a double-blind randomized controlled trial comparing the effect of~     Ophiocephalus striatus extract in elderly patients with malnutrition. The measured outcomes~     are the level of IGF-1, albumin, and MNA score.~   "
38281|NCT03065582|"~     Visible light is known to induce pigmentation in darker skin types. The investigators aim to~     study the effects of visible light on the skin after topical application of sunscreen plus~     antioxidant.~   "
38282|NCT03065569|"~     A trial comparing outcomes for different epidural techniques in labour analgesia~   "
38283|NCT03065556|"~     This Phase 2 study (Study 203) has been designed to determine and compare the efficacy and~     safety of 188-0551 Solution and Vehicle Solution applied twice daily for up to four weeks in~     subjects with plaque psoriasis. Subjects will be instructed to apply the test article~     (188-0551 Solution or Vehicle Solution) to all psoriasis plaques within the designated~     Treatment Area twice daily for four weeks (Study Day 29), unless the investigator verifies~     the subject's psoriasis has cleared at Day 15, then test article application will be for 2~     weeks (Study Day 15).~   "
38284|NCT03065543|"~     A study conducted to evaluate the efficacy of lipid-lowering therapy in patients with high~     and very high risk treated by interventional cardiology. Study endpoints:~        1. Achievement of the target LDL-C at 1-year follow-up LDL-C <70 mg / dl in the group of~          very high-risk and LDL-C <100 mg / dL in high-risk patients~        2. Assessment of the lipid profile of the severity of coronary artery disease in patients~          undergoing invasive diagnosis of coronary artery disease~        3. Evaluation of trends in the treatment of lipid-lowering in patients in different years~   "
42271|NCT03013439|"~     The trial is an open-label, 4 cohorts, sequential, dose-escalating, single dose trial.~   "
38286|NCT03065517|"~     The goal of this Phase II Small Business Innovation Research (SBIR) is to develop, evaluate,~     and commercialize a linked parent-youth mobile app system, VillageWhere, to support the key~     treatment targets of evidence-based treatments for youth with conduct disorders: clear~     parental expectations, parental monitoring, discipline consistency, and parental support,~     while simultaneously cultivating intrinsic motivation in youth toward prosocial behaviors.~     When used in conjunction with an evidence-based treatment for delinquent youth, VillageWhere~     could help reduce treatment length and cost. When provided in non-evidence-based clinical~     settings, VillageWhere may increase access to state-of-the-art clinical techniques to those~     who might not otherwise receive them. Investigators will conduct usability and acceptability~     tests of new features with target-end-users (youth and their parents) and key stakeholders~     (i.e., probation officers, clinic administrators). Once usability and acceptability is~     achieved, investigators will conduct a 16-week randomized controlled trial (RCT) comparing~     VillageWhere to an attention-control (placebo) mobile app. We expect that across four time~     points, VillageWhere use will result in greater improvements in parent management practices~     and youth autonomy support, parent-youth communication and connectedness, youth intrinsic~     motivation for positive behavior, and youth conduct problems than the placebo. The RCT will~     occur with 100 parent-youth dyads recruited from various treatment and probation settings,~     and represent clinically-significant conduct-problems of various clinically-significant~     severity levels.~   "
38287|NCT03065504|"~     A noticeably increasing number of patients are asking for naturally based extracts and~     ingredients as supplementary dermatologic remedies. Patients are seeking natural and~     cost-effective skin care alternatives in place of prescription medications and procedures.~     This study will isolate the effects of oral turmeric and assess a combination tablet that~     includes turmeric on sebum production in healthy subjects.~   "
38288|NCT03065491|"~     A large body of evidence confirm the cholesterol lowering effect of red yeast rice,~     phytosterols and L-tyrosol. Because their mechanisms of action mime the ones of chemical~     statins and cholesterol absorption inhibitors, it is plausible that their association will~     provide a more relevant (and safe) LDL cholesterolemia reduction.~   "
38289|NCT03065478|"~     The objective of this observational study is to evaluate the effectiveness of the dietary~     supplementation OnLife in improving signs and symptoms of chemotherapy-induced peripheral~     neuropathy (CIPN) in adult patients who have finished adjuvant oxaliplatin-containing regimen~     (colon cancer) or adjuvant paclitaxel regimen (breast cancer). Furthermore, patient-reported~     outcomes (PROs) and concomitant medication used for the treatment of neuropathic pain will be~     assessed.~   "
38290|NCT03065465|"~     The primary specific aim is to perform a randomized controlled trial (RCT) to compare the~     rebleeding rates and other clinical outcomes of severe, refractory or recurrent non-variceal~     upper GI hemorrhage (NVUGIH) with a new over-the-scope hemoclipping device (OVESCO) versus~     standard endoscopic hemostasis.~   "
38291|NCT03065452|"~     Lumbar stenosis (LSS) is the most frequent degenerative lumbar disease and is the most~     frequent indication for spinal surgery. When non-invasive treatments fail, decompression~     surgery is the gold standard therapy for the majority of patients and generally improves~     symptoms.~      However, few studies have investigated the improvement in posture (radiological parameters)~     after surgery. In lumbar stenosis, patients may present a forward leaning posture (to relieve~     pain), which is responsible for sagittal imbalance.~      The aim of this prospective study was to evaluate the repercussions of decompression surgery~     on sagittal balance and to compare these with aux clinical results. investigators included~     patients operated on for isolated lumbar canal stenosis.~   "
38292|NCT03065439|"~     Purpose This trial study the association between SBT subgroups and postural stability. It is~     theorized that cognitive impairment is more pronounced among patients in SBT group three~     compared to SBT group one and two. Therefore, it is hypothesized that challenging patients'~     balance will have a greater impact on the postural sway among patients in SBT group three~     compared to SBT group one and two in conditions where sensory information is reduced and~     cognitive load is increased.~   "
38293|NCT03065426|"~     This is a prospective, 24-month, longitudinal study of patients planning to undergo bariatric~     surgery (Roux-en-Y Gastric Bypass or Sleeve Gastrectomy) in which we aim to identify~     correlates and predictors of observed weight loss trajectories following bariatric surgery.~     This approach will expand current knowledge by examining the combined impact of empirically~     supported behavioral and biological data in a large sample over time. Intensive measurement~     of problematic eating behaviors, mood, and compliance with diet and exercise regimens~     post-surgery will be analyzed in the context of lterations in parallel with, or in response~     to, changes observed in the gut microbiota. Identifying these post-surgical predictors of~     weight loss and comorbidity resolution will allow for the development of individualized~     interventions to optimize surgery-related outcomes.~   "
38294|NCT03065413|"~     Prospective study. Starting from 2014 all newly appointed 1st year cadets in Naval Academies~     will be enrolled until the class of 2025.~      Physical examination, food frequency questionnaire, physical activity questionnaire,~     anxiety/depression questionnaire, medical history will be filled out at first interview.~      Specific blood tests will be performed. Every participant will be interviewed every three~     years and will complete the same questionnaires.~      Follow up period is determined ten years after last class enrollment~   "
38305|NCT03065270|"~     During pregnancy, pregnant women adopt an atypical pattern position with the intention to~     maintain stability and balance.These postural changes can cause instability at the level of~     the sacroiliac joint with painful condition during pregnancy and postpartum.~      40 % of women have postpartum lumbopelvic instability. In 17 % of cases the lumbopelvic pain~     is perpetuated.~      Another alteration influenced by the gestational status and progress of labor is urinary~     incontinence (UI).~      The mechanism developed by Masai Barefoot Technology (MBT) provides an unstable base. Some~     studies reviewed, indicate that this shoe increases muscle activity, contributes to the~     decrease of joint overload and thereby, decreases pain.~      Objective To compare the efficacy of shoes with unstable sole MBT®, over the use of~     conventional sports shoes, in primiparous women with lumbopelvic postpartum pain.~      Material and Methods Randomized clinical trial. 24 postpartum women from the Gynecology~     Service of the Hospital Universitario Madrid Chiron were included in the study.~      The subjects were randomly divided into experimental and control group.~   "
38295|NCT03065400|"~     The purpose of this study is to test the effectiveness of a drug called pembrolizumab in~     patients with Myeloproliferative Neoplasm (MPN); chronic phase (MF-CP), accelerated phase~     (MPN-AP), or blast phase (MF-BP). Myelofibrosis neoplasm (MPN) is a group of diseases of the~     bone marrow in which excessive cells are produced.~      Pembrolizumab also known as Keytruda is a drug that has recently been approved in the United~     Stated by the Food and Drug Administration (FDA) for the treatment of patients with~     unresectable or metastatic melanoma and disease progression. Pembrolizumab is experimental in~     the treatment of MPN. The researchers want to find out what effects, good and /or bad it has~     on participants and the disease.~      Participants qualify to take part in this research study if have been diagnosed with a MPN~     blood disorder called myelofibrosis (MF). Accelerated (10-19% blasts in the blood or bone~     marrow) and blast phase (>20% blasts in the blood or bone marrow) MPN has been a difficult~     disease to treat. The term blasts refers to immature cells found in the bone marrow. They~     are not fully developed, and therefore, do not yet carry out any particular function within~     the body.~      Funds for conducting this research are provided by Merck and Company, the manufacturer of the~     study drug pembrolizumab.~   "
38296|NCT03065387|"~     There are 2 parts to this clinical research study: Part 1 (dose escalation) and Part 2~     (expansion).~      The goal of Part 1 of this study is to find the highest tolerable dose of neratinib in~     combination with everolimus, Ibrance (palbociclib), or trametinib that can be given to~     patients who have advanced cancer with a specific mutation (EGFR, HER2, HER3, or HER4).~      The goal of Part 2 of this study is to learn if the dose of neratinib in combination with~     everolimus, Ibrance (palbociclib), or trametinib found in Part 1 can help to control advanced~     cancer in patients who have a specific mutation.~      The safety of this drug will also be studied in both parts of the study.~      This is an investigational study. Neratinib is FDA approved and commercially available for~     the treatment of certain early-stage HER2-positive breast cancer. Everolimus is commercially~     available and FDA approved for the treatment of several disease types, including breast~     cancer and renal cell carcinoma. Palbociclib is commercially available and FDA approved for~     the treatment of ER-positive, HER2-negative breast cancer. Trametinib is commercially~     available and FDA approved for the treatment of melanoma with BRAF V600E or V600K mutations.~     The use of this combination to treat advanced cancer with a specific mutation is~     investigational.~      The study doctor can explain how the study drug is designed to work.~      Up to 120 participants will be enrolled in this study. All will take part at MD Anderson.~   "
38297|NCT03065374|"~     This study will evaluate the safety and tolerability of IMM-529 together with standard of~     care (SOC) in patients with Clostridium-difficile Infection.~   "
38298|NCT03065361|"~     The purpose of this study was to assess the handgrip strength; fine motor skills; and hand~     sensitivity of Brazilian children and adolescents with Chronic Kidney Diseases (CKD). The~     sample was composed by 42 children and adolescents, 21 on hemodialysis (group A) and the~     other 21 acted as the control group (group B). The performance of both groups was compared.~     The outcome measures included Jebsen-Taylor Hand Function Test, the Semmes Weinstein~     monofilaments test and Jamar Dynamometer.~   "
38299|NCT03065348|"~     Major surgery in the elderly and frail patient is a challenge. Optimal perioperative~     management is essential for outcome and survival. There is a need for improved~     multidisciplinary approach to improve postoperative outcome in this patient population at~     high risk for postoperative morbidity and mortality. Here the investigators will evaluate the~     implementation of a multimodal prehabilitation program including optimization of nutrition~     (protein and carbohydrate loading), optimization of preoperative hydration and the use of~     regional anesthesia during cystectomy and urinary diversion in a series old frail patients~     and compared/matched them to a historical series of similar patients in terms of early return~     of quality of life using the Convalescence and Recovery Evaluation (CARE) instrument,~     cognition, and postoperative morbidity.~      The importance of patient-reported health status is well recognized and is a facet of~     healthcare quality. In addition it is a valuable means for quantitatively measuring the~     implication of technology adoption for the patient, who typically judges the efficacy of a~     surgical procedure by whether it improves quality of life.~      The objective of this study is to evaluate the implementation of a multimodal prehabilitation~     program in a series old frail patients and compared them to a historical series of similar~     frail patients in terms of early return of quality of life, cognition, and postoperative~     morbidity. The importance of patient-reported health status is well recognized and is a facet~     of healthcare quality. In addition it is a valuable means for quantitatively measuring the~     implication of technology adoption for the patient, who typically judges the efficacy of a~     surgical procedure by whether it improves quality of life.~   "
38300|NCT03065335|"~     Background:~      Most medications that treat depression take weeks or months to work. Researchers want to~     develop fast-acting treatments. One dose of ketamine has a rapid antidepressant effect. For~     most people, this lasts a week or less. Repeated doses of ketamine may help maintain this~     effect.~      Objective:~      Main Study: To study the effects of ketamine in treating depression.~      Ketamine Metabolites Substudy: To study how ketamine effects brain chemistry.~      To study how ketamine effects the brain. This is done by looking at metabolites, which are~     created when a drug is broken down.~      Eligibility:~      Main Study: People ages 18-65 with major depressive disorder and healthy volunteers~      Ketamine Metabolites Substudy: Healthy volunteers ages 18-65~      Design:~      Main Study:~      Participants will be screened in another study, with:~        -  Medical and psychiatric history~        -  Psychiatric and physical exam~        -  Blood, urine, and heart tests~      Participants will be inpatients at NIH for 4 phases totaling 14-20 weeks.~      Phase I (2-7 weeks):~        -  Gradually stop current medications~        -  MRI: Participants lie and perform tasks in a machine that takes pictures of the body.~        -  Mood and thinking tests~        -  Blood and urine tests~        -  Sleep test: Monitors on the skin record brain waves, breathing, heart rate, and movement~          during sleep.~        -  Transcranial magnetic stimulation: A coil on the scalp gives an electrical current that~          affects brain activity.~        -  Stress tests: Electrodes on the skin measure reactions to loud noises or electric~          shocks.~      Phase I tests are repeated in Phases II and III and in the final visit.~      Phase II (4-5 weeks):~        -  4 weekly IV infusions of ketamine or a placebo during an MRI or MEG. For the MEG, a cone~          over the head records brain activity.~      Phase III (optional):~        -  8 infusions of ketamine over 4 weeks~      Phase IV (optional):~        -  Symptoms monitoring for 4 weeks~        -  Participants will have a final visit. They will be offered standard treatment at NIH for~          up to 2 months.~      Ketamine Metabolites Substudy:~      Participants will be screened in another study, with:~        -  Medical and psychiatric history~        -  Psychiatric and physical exam~        -  Blood, urine, and heart tests~      Participants will be inpatients at NIH for 4 days.~      Study Procedures:~      Mood and thinking tests~      Blood and urine tests~      1 infusion of ketamine~      Spinal tap and spinal catheter: Used to get samples of cerebrospinal fluid (CSF). This is a~     fluid that moves around and within the brain and spinal cord. Studying CSF will help us learn~     how ketamine effects brain chemistry~   "
38301|NCT03065322|"~     Women with PCOS and OSA, compared to women with PCOS only, have more severe clinical and~     biochemical features of PCOS and impaired QoL. This is an observational cross-sectional study~     in a secondary care PCOS clinic in the WISDEM Centre, University Hospital Coventry.~      The primary aim of this study is to examine the relationship between OSA and impaired QoL in~     women with PCOS. Study secondary outcomes are to examine the relationship between OSA and the~     clinical and biochemical features in women with PCOS.~   "
38306|NCT03065257|"~     This is a retrospective and prospective multicenter registry to collect long-term data (1~     year) on patients who have or will undergo Endoscopic resection such as EMR, ESD, EFTR, STER,~     etc. within the gastrointestinal tract for endoscopic treatment of early gastrointestinal~     neoplasms involving the resection of the superficial layers, mucosa and submucosa, of the~     tract wall.~      Subjects will be consented for medical chart review.~      The purpose of this retrospective and prospective registry is to assess long term data on~     efficacy, safety and clinical outcome of Endoscopic Resection within the gastrointestinal~     tract (1 year).~      The registry will evaluate efficacy, technical feasibility, clinical outcome, safety profile~     and overall clinical management through medical chart review. The procedures the~     investigators are evaluating are all clinically indicated and will not be prescribed to~     someone to participate in this registry study.~   "
38307|NCT03065244|"~     Kawasaki disease (KD) is a self-limited illness that affects the heart blood vessels~     (coronary arteries) of infants and children and is now the most common cause of acquired~     heart disease in children. A mixture of proteins from human blood (Intravenous~     immunoglobulin, IVIG) is a treatment that reduces the rate of the major complication of the~     disease: a bulging of the wall of the coronary arteries called an aneurysm. However, 10-20%~     of children are resistant to this treatment and the fever returns. These children have the~     highest rates of aneurysm formation and thus should be treated aggressively. Unfortunately,~     there are no guidelines for the best secondary treatment for these resistant patients because~     the problem has never been adequately studied. Most physicians choose either a second~     infusion of IVIG or an engineered antibody called infliximab that inactivates a molecule that~     promotes inflammation. This trial will randomize (assign by chance like the flip of a coin)~     IVIG-resistant patients to receive either a second IVIG infusion or infliximab and the~     response to treatment will be compared to learn which treatment stops the fever the fastest.~     In addition, parents and caregivers will provide observations about their child's response to~     the different treatments.~   "
38308|NCT03065231|"~     Vasospasm is a common complication after rupture of intracranial aneurysms causing~     devastating neurologic deficits and death. Vasospasm has been directly associated with the~     amount of subarachnoid blood inside the basal cisterns. Prior literature has attempted to~     refine treatment of ruptured intracranial aneurysms but does not have clear guidelines on the~     optimal method to drain subarachnoid blood. Two methods, extraventricular drain (EVD) and~     lumbar drain (LD) have been compared retrospectively yet remain controversial as to which~     method is optimal in reducing subarachnoid blood and preventing vasospasm. This study would~     be a prospective randomized trial in which patients would be assigned to EVD or LD and~     observed to see if one method of intervention is associated with preventing clinical~     vasospasm, decreasing subarachnoid blood, shortening overall ICU stay, and reducing the need~     for a permanent ventriculoperitoneal shunt. The conclusions of this study may identify an~     optimal treatment modality to benefit all future patients with ruptured intracranial~     aneurysms.~   "
38309|NCT03065218|"~     This study is being done to see if the radioisotope 99mTc sestamibi scans can locate what is~     causing the elevated serum thyroglobulin in persons with differentiated thyroid cancer who~     have elevated serum thyroglobulin levels and negative diagnostic imaging tests.~      This is for patients with:~        -  Elevated suppressed or stimulated thyroglobulin level (Tg) > 10 ng/ml with or WITHOUT~          thyroglobulin antibodies ,~        -  All NEGATIVE standard diagnostic clinical imaging studies (NSDCIS) = negative ultrasound~          (US), diagnostic radioiodine scan (DRS), chest-x-ray (CXR), computer tomography with or~          without contrast (CT), and 18F-Fluoro-deoxyglucose positron emission computer tomography~          scan (18F-FDG PET) within the last 12 mos.~        -  If EDCIS (extensive diagnostic clinical imaging studies of 18F-sodium fluoride positron~          emission computer tomography scan (18F NaF PET) or 99mTc methylene diphosphonate bone~          scan (99mTc MDP), AND negative brain CT or magnetic resonance (MR) are performed, these~          are also negative.~      Voluntary patients will have sestamibi scan performed in 4 phases:~      Phase 1: receive an injection into their vein of a radioisotope called 99mTc sestamibi.~      Phase 2: wait for 60 to 90 minutes in a waiting room~      Phase 3: imaged lying face up on an imaging table while a camera passes around you from the~     top of the head to approximately the level of knees. This requires approximately 45 minutes~      Phase 4: images will be reviewed by the nuclear medicine physician. This will take ~10-15~     minutes. If additional images are required to clarify an image, then additional images of~     that area will be performed on the same camera or an alternate camera. As earlier, the~     additional images performed lying face up. These images require ~20-45 minutes. The patient~     will then be released.~      The risk of this study is considered very low, and the potential benefits to the patient are~     considered very high.~   "
38310|NCT03065205|"~     To determine if an asthma navigator is helpful in improving communication between care~     providers and improving patient adherence to asthma medications after an asthma exacerbation.~   "
38311|NCT03065192|"~     Safety and efficacy of AADC gene transfer in participants with Parkinson's disease.~   "
38312|NCT03065179|"~     This is a multi-institution, single-arm phase II study to determine the safety and efficacy~     of SBRT (up to 2 metastatic sites preferentially lung, mediastinum or bone in combination of~     nivolumab and ipilimumab in patients with metastatic renal cell carcinoma(with a clear-cell~     component and at least 1 measurable metastatic lesion that is not being irradiated).~   "
38313|NCT03065166|"~     This study assesses the acute effects of dried Cabernet grape intake on vascular function and~     platelet reactivity in postmenopausal women. Previous studies from this lab and others have~     demonstrated acute effects on vascular function and platelet reactivity from phenolic-rich~     food sources. Postmenopausal women are suggested as the study group, as they are likely to~     have compromised vascular function due to the loss of protective estrogen, and have been the~     study group for past and present research projects in this lab.~   "
38314|NCT03065153|"~     The aim is to investigate the biomechanical interaction between trunk and gait performance in~     both healthy and stroke subjects. People after stroke often have an impaired trunk function,~     resulting in balance and gait disorders. Pathological movement patterns after stroke can be~     compared with normative data as motion capture systems provide more sensitive data to explore~     the interaction between trunk performance and gait in contrast to the clinical measures used~     in literature.~   "
38315|NCT03065140|"~     Early research found that high levels of fat within muscle meant poorer control of blood~     sugar. However, more recent research has shown that athletes have similar levels of fat~     within muscle, but in contrast, they have very good control of blood sugar. The investigators~     are not sure why this is and want to find out if the fat within muscle can be changed to~     improve blood sugar control, as good blood sugar control reduces the risk of heart disease,~     diabetes and stroke.~   "
38333|NCT03064906|"~     To assess the safety and performance of the Insulet AP (artificial pancreas) system, using~     the Omnipod® insulin management system, Dexcom G4 Share® AP System and personalized model~     predictive control algorithm in adults with type 1 diabetes consuming high fat meals and~     undertaking moderate intensity exercise.~   "
38317|NCT03065114|"~     Preimplantational genetic screen (PGS) is tool for diagnosis of embryo chromosome abnormality~     before transfer. Under this tool, patients with a family history of genetic disease or~     special genetic disease could avoid to produce chromosomal abnormalities of the next~     pregnant. This study is a retrospective study, data collection from 2001 Jan. to 2015. Nov.~     Patients underwent PGS and data including the couples age, infertility factors, stimulation~     protocols, medicine records, embryo quality records and blood tests were collected in this~     study. Analysis the relationship between outcomes of PGS, clinical outcomes and embryo~     quality is performed and further to find a diagnosis reference for clinical care.~   "
38318|NCT03065101|"~     The purpose of this study is to compare the Trigen InterTAN Intramedullary nail to Sliding~     Hip Screws in AO/OTA 31-A1 and A2 intertrochanteric hip fractures.~   "
38319|NCT03065088|"~     The feasibility randomised controlled trial is part of the EU funded project PreventIT~     (2016-2018) responding to the Horizon 2020, Personalised health and care (PHC), call PHC-21:~     Advancing active and healthy ageing with ICT: Early risk detection and intervention. The~     PreventIT project focuses on a new behaviour change activity approach for young older adults~     (61-70 years of age) with an overall aim of early prevention of functional decline and to~     empower people to take care of their own health.~   "
38320|NCT03065075|"~     To determine if phenazopyridine reduces the rate of postoperative urinary retention after~     pelvic organ prolapse surgery.~   "
38321|NCT03065062|"~     This research study is studying a combination of drugs as a possible treatment for cancer~     that might have a specific change in the phosphatidylinositol-3 phosphate (PI3K) pathway.~   "
38322|NCT03065049|"~     The primary aim of this study is to develop a feasible, acceptable, and effective multilevel~     physical activity (PA) intervention that addresses both individual and interpersonal factors~     that can be easily scalable and delivered in the context of a methadone clinic. To do so, the~     investigators will train methadone maintenance treatment (MMT) patients who are already~     engaging in PA at public health recommended levels to deliver a group-based PA intervention~     to physically inactive MMT patients at a large community-based methadone clinic. Through the~     development of interpersonal relationships and social support, the investigators expect that~     MMT peers who have successfully navigated challenges associated with PA in this population~     (i.e. depression, smoking, triggers for drug use in environment) will help physically~     inactive MMT patients increase self-efficacy and motivation for initiating and sustaining PA.~   "
38323|NCT03065036|"~     The purpose of this study is to evaluate the ocular hypotensive effect of the Hydrus Aqueous~     Implant (Standard and Low-Profile), as determined by the change in IOP from baseline~     (preoperative) and change in the number of glaucoma medications from baseline.~   "
38324|NCT03065023|"~     This is a Phase I/II multicenter, first-in-human open-label, dose escalation study to~     evaluate the safety, tolerability, and anti-tumor activity of intratumoral/intralesional~     injections of RGT100-PEI in subjects with selected advanced or recurrent tumors.~   "
38325|NCT03065010|"~     A Multicenter Open-label Non-comparative 2-Stage Phase 1a/1b Study to Assess the Safety and~     Pharmacokinetics of Oral BCD-115 (JSC BIOCAD, Russia) in Combination with Endocrine Therapy~     in Women with ER(+) HER2(-) Local Advanced and Metastatic Breast Cancer~   "
38326|NCT03064997|"~     Prebiotics are known as substances affecting beneficially the organism by restoring the~     intestinal microbiota balance, stabilizing the intestinal barrier and modulating the~     endocrine and immune functions. In many persons suffering from celiac disease (CD), despite a~     gluten-free diet (GFD), an impaired intestinal barrier functionality, accompanied by altered~     intestinal microbiota and ongoing intestinal inflammation is observed. For these reasons,~     prebiotic could be a promising and low-risk adjuvant in the dietetic management of CD. It was~     hypothesize that prebiotic preparation Synergy 1 consumed by CD children as a supplement of a~     GFD will affect beneficial the intestinal permeability and intestinal microbiota without side~     effects.~   "
38327|NCT03064984|"~     Topical preparations (eye drops) derived from the blood have become a relatively common~     treatment for more advanced forms of keratopathy. The purpose of this study is to evaluate~     the effect of two blood components from donors (serum cord blood and serum from adult subject~     donor peripheral blood) in the treatment of severe keratopathies.~   "
38328|NCT03064971|"~     This study proposes to test the value of a culturally specific program for African American~     smokers to quit smoking.~   "
38329|NCT03064958|"~     The investigators aim to conduct a 3-period randomized controlled crossover study to~     investigate the postprandial effects of a high fat meal with spice on endothelial function,~     lipids/lipoproteins, immune function and plasma markers of antioxidants and oxidative stress.~     Metabolomic profiling will also be conducted. In random order, participants will consume~     either a high fat meal (1000kcal, 45g fat) or a high fat meal containing 2g of spice or a~     high fat meal containing 6g of spice. Between each treatment there will be a washout period~     of at least 3 days. It is hypothesized that consumption of a high fat meal with spice will~     attenuate postprandial endothelial impairment and triglyceride levels in a dose response~     manner compared with a high fat meal.~   "
38330|NCT03064945|"~     This is a randomized, controlled, multi-center, single-arm, crossover, double-blind clinical~     study assessing the Livia Transcutaneous Electrical Nerve Stimulation (TENS) in women~     suffering from dysmenorrhea. The study will be conducted at community clinics. Advertisement~     will be used to publish and promote recruitment.~      The study will include 3 visits: Screening visit and two consecutive visits each one after~     monthly menstrual period. Treatment will be self-administrated and during the study, the~     subjects will be requested to complete home diaries.~   "
38331|NCT03064932|"~     This study is a randomized 3-period crossover, controlled feeding study designed to evaluate~     the effects of the most commonly consumed spices in the U.S. on CVD risk factors,~     inflammation & immune function, and diet satisfaction in participants at risk for CVD.~   "
38332|NCT03064919|"~     The purpose of this multi-year project is to develop an evidence-based curriculum for~     teaching preschool children to eat in response to internal hunger and fullness signals. There~     are currently no validated methods for teaching children these basic skills, despite the fact~     that doing so is necessary to prevent the development of obesity.~   "
38334|NCT03064893|"~     Breast reconstruction after mastectomy has been shown to provide psychosocial benefits to~     breast cancer patients and is considered an integral part of breast cancer treatment. In~     general, breast reconstruction can be accomplished using the patients own tissues or~     implantable prosthetic devices. Various acellular dermal matrices (ADMs) are offered on the~     market and the costs vary widely despite very similar qualities. The two most commonly used~     ADM products in North America by far are Dermacell and Alloderm. The difference between the~     two products include a) level of sterility, with Dermacell being sterilized to 10-9 while~     Alloderm is sterilized to 10-6 and b) the consistency and thickness of the biologic material~     and c) a significant different in cost ($2200 CAD vs $3600, respectively). Each product has~     shown to be safe and effective. As such, clinical equipoise exists. This will be a pragmatic~     trial to evaluate Dermacell with Alloderm in a head to head randomized fashion, with regards~     to the postoperative complications, namely infection, seroma formation (as measured by drain~     duration and output), loss of implant, incidence of revisional surgery and capsular~     contracture.~   "
38335|NCT03064880|"~     Intraoperative goal-directed fluid therapy (GDFT) is proposed to improve the outcomes of~     patients undergoing major surgery. In the GDFT algorithm, the employment of fluid bolus plays~     a crucial role. Dynamic fluid responsiveness parameters, such as stroke volume (SV) response~     to fluid infusion, are precise fluid indicators that specifically determine patient volume~     status and are helpful for clinicians to determine the appropriate time for fluid bolus. In~     this study, we compared two fluid strategies guided by SV response, namely maximization and~     nonmaximization protocols, during intraoperative GDFT for patients undergoing thoracic~     surgery requiring one-lung ventilation. Clinical outcomes and perioperative changes in serum~     biomarkers of oxidative injury were compared between the two groups as the primary and~     secondary outcomes respectively.~   "
38336|NCT03064867|"~     The purpose of this study is to determine the correct dose and safety of adding a new cancer~     drug, venetoclax, to a standard combination of chemotherapy drugs as a second treatment for~     relapsed/refractory DLBCL. In this study, venetoclax will be added to RICE (rituximab,~     ifosfamide, carboplatin, etoposide), a common set to cancer drugs used as a second line~     treatment for relapsed/refractory DLBCL.~      Venetoclax, is a new targeted anti-cancer drug, which works by mimicking a particular protein~     produced by the tumor and interrupting its normal processes, ultimately causing the tumor~     cells to die. Adding venetoclax to the standard RICE regimen is believed to increase the~     chance of getting cancer into remission.~      Venetoclax is experimental because it is not approved by the Food and Drug Administration~     (FDA) for the treatment of relapsed/refractory DLBCL. Venetoclax has been FDA approved for~     use in patients with chronic lymphocytic leukemia (CLL).~   "
38337|NCT03064854|"~     The primary purpose of this study is to establish the maximum tolerated dose (MTD) and/or~     recommended dose for expansion (RDE) of PDR001 when administered in combination with~     platinum-doublet chemotherapy in treatment naive patients with PD-L1 unselected, advanced~     NSCLC, and to estimate the preliminary anti-tumor activity of PDR001 in combination with~     platinum-doublet chemotherapy in this patient population.~   "
38338|NCT03064841|"~     This is a multi-centre, cross-sectional, non-interventional study assessing blood glucose~     target attainment, anti-hyperglycaemic treatment pattern and the clinical characteristics in~     older outpatients with T2DM in hospitals of China. This study is designed to collect~     information of older T2DM patients in a real life setting~   "
38339|NCT03064828|"~     This preliminary clinical trial aims to evaluate the performance of the low-dose CT~     colonoscopy (CTC) with computer aided detection (CAD) on polyps detection compared with~     optical colonoscopy (OC), and explore the possible clinical routine for integrated use of CT~     colonoscopy and optical colonoscopy OC in colorectal cancer screening.~   "
38340|NCT03064815|"~     Inflammatory bowel disease is clinically associated with spondylarthropathies in 5-15% of~     cases. Protocol colonoscopic assessment demonstrated asymptomatic inflammation characteristic~     of Crohn's disease in up to 1/3 of SpA patients. Videocapsule endoscopy is a superior~     diagnostic tool to detect small bowel mucosal pathology. However, it has been infrequently~     used to evaluate bowel inflammation in spondylarthropathies. This study compared the accuracy~     of videocapsule endoscopy to standard ileocolonoscopy for the detection of inflammatory bowel~     lesions in patients with spondylarthropathies, and to describe the clinical and laboratory~     predictors of small bowel inflammation in this cohort.~   "
38341|NCT03064802|"~     A multicenter patient registry was created with aim of documenting how spine and~     neurosurgeons are utilizing Burst Biologics products along with patient outcomes. These~     include radiographic measures such as fusion outcome, instrumentation integrity, and clinical~     outcomes (symptom and function improvement) based on surgeon and patient based outcome~     assessments.~   "
38342|NCT03064789|"~     Epidemiological study about the clinical and microbiological progress in subjects under~     treatment for a severe vulvovaginal candidiases episody~   "
38343|NCT03064776|"~     m-RESIST is an m-health intervention program aimed to develop, test and evaluate a tool to~     allow patients suffering from treatment-resistant schizophrenia to self-manage their~     condition. This may facilitate acceptance and involvement of patients with their own~     treatment, as well as of caregivers. Moreover this programme could provide a new tool to the~     psychiatrist, psychologists working together with other health care professionals, to better~     monitor patients, through a personalised and optimised therapeutic process.~      The present document corresponds to the pilot field-trials phase included in a three year~     European research project, co-funded by the Horizon 2020 Framework Programme of the European~     Union (grant agreement nº 643552). This document summarises the protocol of the whole~     therapeutic process, specifying all the procedures included in the program. This protocol~     will be implemented in three countries: Israel, Hungary and Spain, in order to test~     acceptability, usability, satisfaction and changes in the quality of life reported by the~     end-users.~   "
38344|NCT03064763|"~     No formal statistical hypothesis will be tested for safety endpoints in this trial. Based on~     the well tolerated safety profile from a global phase 3 study, it is hypothesized that~     talimogene laherparepvec will be safe and well tolerated in Japanese subjects with~     unresectable Stage IIIB-IVM1c melanoma. A DRR is hypothesized to be consistent with results~     from the global phase 3 study~   "
38345|NCT03064750|"~     The lifetime risk for a woman to undergo surgery for either vaginal prolapse or urinary~     incontinence is high. There are many different surgical techniques for treatment of prolapse,~     but there is a lack of knowledge about factors that contribute to objective result and~     patient satisfaction after surgery.~      The aim of the study is to investigate factors that could be related related to patient~     satisfaction and objective result such as pelvic floor muscle contractility/strength and~     muscle injury, objective measures of prolapse and women's symptoms. This study will~     investigate whether systematic pelvic floor exercise and life style advise before surgery can~     improve outcomes after surgery for either vaginal prolapse. Another aim is to determine an~     ultrasound scale for measure of pelvic floor muscle contraction.~   "
38346|NCT03064737|"~     Legionnaires' disease (LD) is a relatively common pneumonia in France (1200 cases/year), 98%~     of cases are hospitalized and 40% require intensive care unit (ICU) admission. Risk factors~     that may predispose to acquisition of LD are well known. Some studies suggest that genetic~     factor may also enhance susceptibility to LD.~      The mortality rate remains high (10% to 33% in ICUs) despite improved diagnostic and~     therapeutic management of patients. Few prospective studies have assessed the factors~     associated with LD outcomes, particularly death, and most of them involved a limited number~     of patients.~      In a multicentre cohort study, the investigators recently identified risk factors associated~     with higher mortality such as female sex, age, ICU stay, renal failure, corticosteroid~     treatment and enhanced pro-inflammatory status, as assessed by higher C-reactive protein~     level (PMID: 22005914). Other factors are suspected but their involvement has not been~     formally demonstrated including a high infectious bacterial load, particular virulence of~     Legionella strain, and an in vivo selection of mutants resistant to prescribed antibiotics.~     Disease progression is highly variable from one patient to another, and usually remains~     unpredictable. There are no objective criteria to predict the prognosis of these patients.~      The clinical course of patients with LD remains difficult to predict because no predictive~     biomarkers have yet been characterized and the demonstration of the presence of mutants to~     antibiotics in vivo has never been done.~      The main objective of the study is to correlate the L. pneumophila load (detected by PCR) to~     the clinical outcome of the LD infection. Clinical severity will measured by the SOFA score~     (Sepsis -Related Organ Failure Assessment) or the PELOD score (Pediatric Logistic Organ~     Dysfunction).~      Secondary objectives are to identify new host and bacterial biomarkers associated with poor~     outcome of LD.~   "
38347|NCT03064724|"~     This pilot project examined the feasibility of an multilingual interactive video education~     intervention an interactive Mobile Doctor intervention (iMD) to promote patient-provider~     discussion on tobacco use for Korean- and Vietnamese-speaking male patients at primary care~     settings.~   "
38348|NCT03064711|"~     Background: Early diagnosis of respiratory impairment in Post-Polio (PPS) patients may delay~     respiratory decline and future need of invasive respiratory aids.~      Objectives: To compare pulmonary function measures, maximal respiratory pressure and activity~     levels and fatigue of respiratory muscles between patients with PPS and healthy controls.~      Design: Cross-sectional study. Setting: Hadassah physical medicine and rehabilitation~     department, Jerusalem. Patients: Patients with PPS (N=12; 6 males; age 62.1±11.6 years) able~     to walk for 6 minutes without human assistance; age-matched healthy subjects (N=12; 4 males;~     age 62.2±6.5 years).~      Intervention: None. Measurements: A body plethysmograph was used to quantify forced~     expiratory volume in the first second of a forced expiratory maneuver, vital capacity, slow~     vital capacity, Residual Volume (RV), Total Lung Capacity (TLC), and Thoracic Gas Volume~     (TGV). Also, RV to TLC ratio is calculated. A manometer was used to measure Maximal~     Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP). A spirometer was used to~     measure Maximal Voluntary Ventilation (MVV). Surface electromyography (sEMG) recorded~     diaphragmatic muscle activity during rest and while performing MVV.~   "
38349|NCT03064698|"~     In uncomplicated pregnancies, the uterine spiral arteries undergo a series of structural~     changes that result in a low resistance in the uterine arteries as pregnancy progresses.~      In many pregnancies complicated with preeclampsia, growth restriction and other placental~     related complication, the described change does not occur. In pregnancies at high risk for~     placental complications, doppler measurement of Uterine artery flow has been shown to be a~     reliable predictor of complications.~      Postpartum there is a reversal of vascular changes seen in normal pregnancies. It is unclear~     if there is a full reversal of these changes in complicated pregnancies with abnormal flow~     during pregnancy.~      The investigators hypothesize that Doppler uterine artery measurements after complicated~     pregnancies will show some abnormality compared to doppler measurements following~     uncomplicated pregnancies.~   "
38350|NCT03064685|"~     Objective: the aim of this study is to identify risk factors associated with the development~     of pyogenic liver abscesses (PLA) in adult liver recipients (ALR) and to describe the~     experience of the Hospital Italiano de Buenos Aires (HIBA) in the diagnosis and therapeutic~     management of these patients.~      Background: adult liver recipients differ from the general population with PLA as they~     exhibit: reconstructed biliary anatomy, recurrent hospitalizations, regular performance~     status and are subjected to immunosuppression. However, the scientific evidence regarding PLA~     developed in transplanted organs is still scarce and the management of this disease continues~     to be based on experience in non-transplanted patients.~      Methods: between 1996 and 2016, 879 adult patients underwent liver transplantation (LT) at~     our institution. Patients who developed PLA after LT (cases) and controls are matched~     according to the time from transplant to abscess in a 1 to 5 relation. The investigators~     performed a logistic regression model to establish PLA risk factors considering clusters for~     matched cases and controls. Independent risk factors will be identified using multivariate~     regression analysis.~   "
38351|NCT03064672|"~     This prospective cohort study aims to determine whether maternal and neonatal outcomes are~     affected by GBS carrier status in women undergoing transcervical balloon catheter insertion.~   "
38352|NCT03064659|"~     During general anesthesia, functional residual capacity (FRC) is reduced. If the FRC is lower~     than the minimum volume required to maintain the opening of the airways, there is a~     derecruitment of the lung parenchyma, leading to the phenomenon of expiratory flow limitation~     (EFL).~      The Driving Pressure (DP) is the difference between the plateau pressure (Pplateau) and the~     Positive End-Expiratory Pressure (PEEP), and estimates the lung strain.~      The incidence of EFL and the importance of DP are not known in adult cardiac surgery, so it's~     necessary a study to assess both. The primary end-point of the study is to evaluate the~     correlation of DP and EFL with PPCs in adult cardiac surgery. The secondary end-point of the~     study is to evaluate: the mechanical ventilation time, the length of ICU and hospital stay,~     the rehospitalization and mortality.~      It will be a prospective, observational, non-pharmacological study. It will enroll 200~     patients undergoing elective adult cardiac surgery.~   "
38353|NCT03064646|"~     PRONAR trial aims to assess if treatment with organ preservation in stage II and III rectal~     cancer after a complete or almost complete response to neoadjuvant treatment is feasible and~     safe in our environment.~      The main objective of this project is to implement the organ preservation strategy in the~     treatment of rectal cancer in our environment within a clinical study that allows the~     analysis of its results in terms of survival.~      The secondary objective is to assess local relapse, distant relapse and quality of life.~   "
38354|NCT03064633|"~     The transversus abdominis plane (TAP) block is most often used to provide surgical anesthesia~     for minor, superficial procedures on the lower abdominal wall, or postoperative analgesia for~     procedures below the umbilicus providing anesthesia to the ipsilateral lower abdomen below~     the umbilicus.~      In a recent meta-analysis, the TAP block was shown to reduce the need for postoperative~     opioid use, increase the time to the first request for further analgesia, and provide more~     effective pain relief, while decreasing opioid-related side effects such as sedation and~     postoperative nausea and vomiting. The provision of effective postoperative analgesia is of~     key importance to facilitate early ambulation and prevention of postoperative morbidity. The~     analgesic regimen needs to meet the goals of providing safe, effective analgesia, with~     minimal side effects. Many additives to local anesthetics used to prolong the duration of~     analgesia for peripheral nerve blocks have been studied as dexamethasone, dexmedetomidine~     Dexmedetomidine is a lipophilic α2 agonist derivative with a higher affinity for α2-receptors~     than clonidine (α2: α1 specificity ratio is 200:1 for clonidine and 1600:1 for~     dexmedetomidine). It has sedative, analgesic, and sympatholytic effects that blunt many of~     the cardiovascular responses seen during the perioperative period. Animal and human studies~     have shown safety and efficacy of adding dexmedetomidine to local anesthetics in various~     regional anesthetic procedures. The addition of dexmedetomidine to bupivacaine in TAP block~     achieves better local anesthesia and provides better pain control postoperatively without any~     major side-effects.~      Dexamethasone is a systemic glucocorticoid that improves the quality of recovery after~     surgery by reducing pain, nausea, and vomiting. When added to local anesthetics as an~     adjuvant in peripheral blocks, it prolongs the analgesia time. Mechanism of action may be~     through the anti-inflammatory action, the increase of the local efficiency, and to slow down~     of the absorption.~      Objective:~      The objective is to compare and evaluate efficacy and safety of dexmedetomidine and~     dexamethasone as a local anesthetic adjuvant to bupivacaine in ultrasound-guided TAP block~     for patients scheduled for total abdominal hysterectomies.~   "
38355|NCT03064620|"~     Objective: PCV effects on S. pneumoniae and S. aureus carriage in a population based study.~     The major specific aims:~        1. To compare different PCV vaccination policies, by cross-sectional repeated surveillance~          of closely related populations living in regions with different vaccination policies.~        2. To compare the epidemiology, predictors and outcomes of antibiotic resistant S. aureus~          and S. pneumoniae in different regions of the PICR.~      Study design: Annual / Biannual cross-sectional surveillance of nasal S. aureus carriage and~     nasopharyngeal S. pneumoniae carriage in children and one of their parents.~   "
38356|NCT03064607|"~     The purpose of the study is to quantify biomarkers of neural damage in neonates exposed to~     varying levels of volatile anesthetic in utero.~   "
38357|NCT03064594|"~     This retrospective study is to find out the best way to treat patient with cornual pregnancy~     in the aspect of further pregnancy outcome.~   "
38358|NCT03064581|"~     This community-based randomized trial tested the effects of a social support intervention to~     increase Chamorro, Samoan, and Tongan women's Pap test behavior and social support among~     their male spouses or significant others in Southern California.~   "
38359|NCT03064568|"~     Purpose is to identify if misoprostol in addition to local vasopressin decreases blood loss~     when compared to vasopressin alone, which is our current practice at this time. The study~     will be double-blinded with neither the patient nor the researcher knowing whether the~     placebo or the misoprostol was given. We will monitor patients for decrease in hemoglobin and~     hematocrit, need for transfusion, and operative time among other measures of perioperative~     morbidity to see if the addition of misoprostol makes a significant difference. We will also~     observe patients to see if there are any side effects of misoprostol that make its use~     undesirable.~   "
38360|NCT03064555|"~     Chronic kidney disease (CKD) affects between 5-10% of the world's population, equating to~     ~740 million people worldwide. End stage renal disease (ESRD) is the result of a progressive~     loss of kidney function where the patient requires dialysis to replace the typical functions~     of the kidney. The quality of life of these individuals can be poor as a result of various~     complications associated with CKD (e.g. heart disease, diabetes, muscle wastage, decreased~     fitness). In an attempt to combat reduced physical fitness, many studies have applied long~     term exercise programmes. However, the body's response to exercise in people with CKD is not~     well understood and a set of guidelines that informs safe and effective exercise prescription~     is lacking.~   "
38361|NCT03064542|"~     To determine how thyroid status regulates the relationship between brown adipose tissue (BAT)~     volume/activity, white adipose tissue (WAT) partitioning and basal metabolic rate (BMR) in~     hyperthyroid patients transitioning to euthyroidism via antithyroid drugs.~      To compare euthyroid outcomes (BAT, WAT, BMR, body composition, body weight and insulin~     resistance) achieved by hypothalamus-pituitary-thyroid (HPT) set point vs. normal ranges of~     plasma free thyroxine 4 (FT4) and throxine stimulating hormone (TSH).~   "
38362|NCT03064529|"~     The present study aims to establish the feasibility of the clinical use of 3-axis~     accelerometers to measure physical activity in hospitalized children after elective surgery.~   "
38363|NCT03064516|"~     Objective: To evaluate the immediate and mediate outcomes of endocrowns and onlay ceramic~     restorations with glass fiber pin in endodontically treated teeth. Material and methods: A~     randomized controlled clinical trial, a double-blind (patient and examiner) is conducted by~     two trained and calibrated operators who perform all restorative procedures. The restorations~     are evaluated longitudinally by a blind and calibrated examiner using the USPHS. A total of~     34 patients will be randomly assigned to each group for a total of 68 patients. The~     randomization sequence will be generated (www.sealedenvelope.com) and to ensure the~     confidentiality of the allocation, this will be used opaque, sealed and numbered envelopes in~     series. These will be kept with an independent researcher for the moment of inclusion of the~     subjects. In the group of onlays, the teeth receive a fiberglass pin in the main root canal~     and composite resin filling. In the group of endocrown, only the restoration fill the pulp~     chamber. The parts are milled in IPS e-max CAD (Ivoclar Vivadent) and cemented with the~     Multilink cementation system (Ivoclar Vivadent). The immediate clinical (focused in~     restoration and patient) and mediate (radiographic and clinical) outcomes will be compared~     between the groups. Survival and success rates will be defined in 6, 12 and 24 months.~     Survival will be established by Kaplan-Meier survival curve and log-rank can be conducted to~     identify as variables associated with as failures over time. Multivariate analysis with the~     Cox regression models will be condutcted for the determination of failure predictors. For all~     analyzes, the significance value will be adjusted to 5%.~   "
38365|NCT03064490|"~     This is a single-institution, prospective phase II trial with an initial safety run-in to~     evaluate the efficacy and safety of neoadjuvant pembrolizumab combined with chemoradiotherapy~     and adjuvant pembrolizumab in patients with locally advanced esophageal and gastric cancers~     (EGC). Chemoradiation therapy (45Gy in 25 fractions with concurrent, weekly carboplatin [AUC~     2] and paclitaxel [50mg/m2 of BSA]) with three cycles of pembrolizumab will be administered~     as neoadjuvant therapy. These patients will also receive three cycles of adjuvant~     pembrolizumab after surgical resection~   "
38366|NCT03064477|"~     The present randomized, controlled trial will compare the cost-efficacy and acceptability of~     the Unified Protocol in group format against traditional individual Cognitive Behavioral~     Treatment in a sample of patients with emotional disorders. Ultimately, the goal of the~     current study is to explore whether the Unified Protocol in group format can be a~     cost-effective psychological intervention for emotional disorders in the Spanish National~     Health System, that is, one that generates long-lasting changes in symptoms, while reducing~     both direct and indirect economic costs associated with the treatment of emotional disorders.~   "
38367|NCT03064464|"~     Community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA), strains of MRSA~     that are able to infect otherwise healthy people outside of hospital settings, emerged in the~     late 1990s and have recently arisen in many countries around the globe. CA-MRSA strains are~     usually distinguished from their HA-MRSA counterparts by the following characteristics:~     Firstly, CA-MRSA strains are usually susceptible to non-lactam antibiotics. Secondly, CA-MRSA~     harbors type IV and V SCCmec elements, which are shorter than the traditional type I, II, and~     III SCCmec elements found in HA-MRSA strains. Thirdly, certain successful clones are~     associated with outbreaks of CA-MRSA infections reported in specific geographical locations.~     For example, ST1 and ST8 isolates are mostly reported in the USA and Canada, ST80 isolates~     are commonly found in Europe, and ST59 isolates are encountered in the Asia-Pacific region.~     Notably, all these characteristics have substantial limitations for discriminating CA-MRSA~     isolates due to their complex backgrounds. Although there were more and more studies of~     CA-MRSA in European countries and the US, few national epidemiological data were available~     about China. In this study, we investigated the epidemiological, clinical and molecular~     characteristics of CA-MRSA isolates recovered in Chinese hospitals, in order to understand~     the changing epidemiology of MRSA in China.~   "
38368|NCT03064451|"~     The primary purpose of this study is to assess the effectiveness of using CARTOFINDER™ maps~     created by the RHYTHMFINDER-192 catheter and the CARTOFINDER™ Algorithm to terminate~     persistent atrial fibrillation (PsAF) to either Normal Sinus Rhythm or Atrial Tachycardia~     compared to pulmonary vein isolation (PVI) in treating PsAF. The RHYTHMFINDER-192 catheter is~     investigational, while the CARTOFINDER™ system is CE marked in Europe.~      All subjects with persistent AF who are scheduled to undergo a clinically indicated ablation~     procedure for management of their persistent AF will be the target population for screening.~     The study will enroll approximately 40-70 subjects. Subjects will undergo CARTOFINDER™ guided~     ablation (CFGA) followed by PVI. Subjects will have follow-up visits at 7 days, 3, 6 and 12~     months postprocedure.~   "
38369|NCT03064438|"~     The study evaluates the safety, efficacy and tolerability of ACCU-D1 when applied twice daily~     for 12 weeks in adult patients with moderate to severe acne rosacea. Two thirds of~     participants will receive ACCU-D1 while one third will receive vehicle control.~   "
38370|NCT03064425|"~     There is great variability in susceptibility from one person to another, and less than one in~     a hundred sexual exposures to HIV results in infection. In addition, some recent trial of~     methods to prevent HIV - including vaccines and microbicides - have actually increased HIV~     acquisition among trial participants for reasons that we do not fully understand. While we~     know that immune differences in the genital lining are an important determinant of whether a~     person is infected after a sexual HIV exposure, we don't know enough about these differences~     to be able to accurately assess a person's individual HIV risk. Therefore, the development of~     safe and non-invasive laboratory tests to estimate a person's susceptibility in the genital~     tract would be useful in clinical studies of new HIV prevention tools.~   "
38371|NCT03064412|"~     Androgens are important sex steroids in women. Androgens influence protein synthesis and~     muscle growth, are involved in maturation of the reproductive organs, have a fat reducing~     effect , have a negative effect on the serum lipid profile, and may also increase insulin~     resistance and coagulation activity. The role of androgens in women is not clear. This study~     is aimed at learning about the amount of androgen and its actions in pregnant women. This~     study is also looking to see if there are specific patient factors (such as genetics) that~     change the amount of androgen and its activity.~   "
38372|NCT03064399|"~     To study the clinical efficacy of microfracture combined with lateral ligament repairment for~     cartilage lesions of talus through the comparison between microfracture with and without~     lateral ligament repairment.~   "
38373|NCT03064386|"~     To compare the clinical efficacy of open reduction and internal fixation (ORIF) with plate~     and screw for postieror malleolar fractures.~   "
38374|NCT03064373|"~     Staphylococcus aureus (SA) is a significant cause of community and hospital acquired~     infections. SA is carried by approximately 30% of healthy adults. Similar carriage rates have~     been reported in very young infants and newborns. Previous studies have suggested that the~     source of SA carriage in young children is SA carried by their mothers. Possible modes of~     transmission from mother to child are transmission during passage through a colonized birth~     canal, through lactation and/or close contact.~      We aim to 1) Define the route of transmission between mother and newborn. 2) Assess the~     dynamics of S. aureus carriage during the first years of life and specifically determine risk~     factors for becoming a persistent carrier of S. aureus~   "
38375|NCT03064360|"~     Usual care may not identify subtle clinical changes that precede a major adverse~     cardiovascular event (MACE). Therefore investigators will explore the effectiveness of using~     biomarkers, patient reported outcomes (PROs), and patient reported informatics (PRIs) as~     predictors to a MACE event.~   "
38376|NCT03064347|"~     This study will evaluate whether enteric-coated nutrients increase some glucose and~     regulating hormone levels, glucose tolerance and satiety in overweight and obese individuals~     with type 2 diabetes.~   "
38377|NCT03064334|"~     In order to assess patients' concerns and other quality of life aspects, post-total knee~     arthroplasty (TKA) requires further assessment tools, more than controlled experiments~     testing defined isolated variables. Qualitative research offers useful methods to explicate~     the complexity and deeper meaning of patient experiences and outcomes post-TKA. Qualitative~     methods facilitate the collection of in-depth experiences and perceptions from individuals~     about a specific phenomenon which, in this case, is outcomes post-TKA. Specifically, a~     phenomenological approach allows for the collection of diverse and unique patient experiences~     and outcomes post-TKA .~      The focus of this project is using focus groups to explore poorly understood areas, such as~     outcomes and experiences post-TKA, in order to generate useful findings and hypotheses.~   "
38378|NCT03064321|"~     This study will test the effect of the an insomnia intervention with cognitive behavioral~     treatment delivered via web compared with an information control group on glucose control and~     self management behavioral in a sample of persons with type 2 diabetes (T2DM).~   "
38379|NCT03064308|"~     The primary aim of this study is to establish if it is possible for patients who have~     undergone major body surgery to complete a home based exercise training program and complete~     the assessments required to measure physical and cognitive function. If the investigators can~     establish that it is feasible to complete the training and test's then further research can~     follow using these methods to determine whether it is possible to improve the physical~     function of older patients undergoing major abdominal surgery in the period following surgery~     by using a simple exercise regimen that can be carried out at home. By targeting physical~     function in this way the investigators hope to determine if it is a method for improving~     frailty and well being. In turn it may also have a positive impact on health service~     provision.~   "
38380|NCT03064295|"~     This study hopes to provide significant technical improvement in a Myocardial Blood Flow~     (MBF) cardiac magnetic resonance (CMR) quantification technique to address challenges and~     technical limitations for MBF CMR. By developing and validating novel techniques to improve~     first-pass perfusion (FPP) cardiac MR, we propose to increase diagnostic accuracy by~     minimizing false positives and false negatives, allow for better evaluation and accurate~     quantification of total ischemic burden and reduce image and motion-induced artifacts.~      The broad, long-term objective of the proposed project is to improve the prognosis of~     patients with myocardial ischemia caused by coronary artery disease (CAD) or coronary~     microvascular dysfunction (CMD).~   "
38381|NCT03064282|"~     Treatment of patients with prostatic hyperplasia with topical papaverine.~   "
38382|NCT03064269|"~     This study will evaluates the safety and efficacy of Chimeric antigen receptor T cells~     (CAR-T) in treating central nervous system B-cell acute lymphocytic leukemia.~   "
38383|NCT03064256|"~     This study compared the changes in the cardiovascular, hemodynamic and metabolic variables of~     hypertensive patients who received aerobic physical training with intensity determined by the~     protocol of double non-exhaustive efforts (DENE) with that of patients who received routine~     outpatient care 12 weeks after Entry into the study. 63 men and women participated in the~     study and were allocated in the intervention group (n = 42) and control group (n = 21).The~     following were performed: Cardiopulmonary exercise test (TECP) for evaluation of peak oxygen~     consumption (VO2peak), oxygen pulse and double product; DENE protocol for the determination~     of the intensity of the training. It was obtained the recording of the intervals between~     consecutive heart beats (iRR) to evaluate the autonomic modulation of the heart rate. Body~     mass index, waist circumference (AC), hip circumference (CQ) and Waist / hip ratio (WHR) were~     measured.~   "
38384|NCT03064243|"~     Apatinib is a kind of innovative medicines approved by China Food and Drug~     Administration（CFDA）, which was researched by Jiangsu Hengrui Pharmaceutical Co., Ltd.~     Apatinib is a kinase inhibitor of receptor tyrosine with VEGFR2. The protocol is to explore~     Apatinib for the effectiveness of advanced soft tissue sarcoma and safety.~   "
38385|NCT03064230|"~     The Female Athlete Triad is a medical condition often observed in physically active girls and~     women, and involves 3 components: (1) low energy availability with or without disordered~     eating, (2) menstrual dysfunction, and (3) low bone mineral density. An early intervention is~     essential to prevent its progression to serious endpoints including clinical eating~     disorders, amenorrhea, and osteoporosis that can affect the quality of life of these patients~     and even compromise the athletic performance.~      All patients, aged between 14 and 40 years, who met the inclusion and exclusion criteria,~     were prospectively enrolled in this observational study and were divided into two groups:~     Athletes agonists (Experimental Group or Group A) and women who do not perform agonistic~     sports (Control Group or Group B). In both groups of patients, the investigators administered~     two types of questionnaires: a standardized quality of Life questionnaire, validated in~     Italian (SF-12) and a screening questionnaire recommended by the Female Athlete Triad Expert~     Panel.~   "
38386|NCT03064217|"~     Crown lengthening surgery is done when a tooth needs to be fixed with a crown. Sometimes, not~     enough of the tooth sticks out above the gum to support a crown. This can happen when a tooth~     breaks off at the gum line, or when a crown or filling falls out of a tooth and there is~     decay underneath. To place a crown, the dentist needs to expose more of the tooth. This is~     done by removing some gum tissue or bone.~      After surgery, the area will heal in about three months. Then, making a crown can begin. This~     healing period often delays the delivery a final crown. This study is investing a way to make~     the final impression at the surgery to expedite the delivery of a final crown.~   "
38387|NCT03064204|"~     The purpose of this study is to help us understand how HIV and/or Anti-Retroviral Therapy~     (ART) may predispose individuals to Obstructive Sleep Apnea (OSA). The traditional risk~     factors for OSA are weight and age. However, people living with HIV on ART seem to have OSA~     even when they are thin and young. The study involves a detailed physiological sleep study~     and an MRI of the head and neck to understand the underlying cause of OSA in those with and~     without HIV.~   "
38388|NCT03064191|"~     Is to evaluate the influence of the calcium hydroxide / chlorhexidine combination and calcium~     hydroxide alone as an intra-canal medication in postoperative flare-up in two visits~     endodontic retreatment cases~   "
40768|NCT03033082|"~     Erectile Dysfunction (ED), previously known as sexual impotence, is defined as the persistent~     inability to obtain and/or maintain a penile erection that is hard enough for satisfactory~     sexual intercourse. The number of reported patients with ED is increasing and it is becoming~     a real medical problem.~   "
38389|NCT03064178|"~     This study had the following aims: i. to determine the relationship between anticipated pain~     and actual pain experienced following periodontal surgery; and ii. determine the factors that~     predict the amount of pain and the amount of pain medication use following periodontal~     surgery.~      It was hypothesized that experienced pain will be significantly less than anticipated pain.~     It was also hypothesized that the following factors will affect pain experienced: sex, type~     of surgery, nervousness, anticipated pain, sedation, age, smoking status, supplement use and~     pain pill usage. It was hypothesized that the following factors will affect pain pill usage:~     sex, type of surgery, nervousness, anticipated pain, sedation, age, smoking status,~     supplement use, and actual pain.~   "
38390|NCT03064165|"~     The study investigates the effect of an obturator nerve block on the postoperative pain and~     opioid consumption after total hip replacement.~   "
38391|NCT03064152|"~     The aim of this study is to evaluate the impact of a rotational thromboelastometry~     (ROTEM®)-based transfusion protocol during postpartum hemorrhage (PPH) after vaginal or~     cesarean delivery. Maternal transfusion requirement, quantitative blood loss (QBL), need for~     intensive care unit (ICU) admission, and length of hospital stay will be evaluated. The~     utilization of ROTEM® for transfusion management will identify patients who develop early~     coagulation changes such as hypofibrinogenemia or disseminated intravascular coagulation. Our~     hypothesis is that earlier identification and directed therapy of such coagulation changes~     will lower overall transfusion requirement (packed red blood cells, fresh frozen plasma,~     fibrinogen concentrate, cryoprecipitate, or other product), reduce the need for ICU~     admission, and shorten length of hospital stay. A cost analysis will be performed.~   "
38392|NCT03064139|"~     This study evaluates the feasibility of a mindful walking intervention for management of knee~     osteoarthritis. Half of the participants will receive the mindful walking intervention while~     the other half will receive education on osteoarthritis management.~   "
38393|NCT03064126|"~     To evaluate the safety and effectiveness of the Ranger™ Paclitaxel Coated Balloon for~     treating lesions located in the superficial femoral and proximal popliteal arteries~     (SFA/PPA).~   "
38394|NCT03064113|"~     Thirty-two subjects diagnosed with COPD were enrolled, received each study treatment and~     completed the follow-up assessments. During each of the four study periods, subjects were~     admitted to the clinic on Day -1 and housed overnight until after the last spirometry~     measurement. Serial pulmonary function tests were performed and PK (pharmacokinetics) samples~     collected up to 25 hours. Subjects were discharged from the clinic on Day 2 after~     evaluations.~   "
38395|NCT03064100|"~     The purpose of this study is to collect data to support decisions made by BioFire regarding~     assay development, panel composition, and intended use for the final FilmArray CSI reagent~     pouch. The study will utilize whole blood and/or plasma obtained from pediatric patients~     under 18 years of age that present with acute fever.~   "
38396|NCT03064087|"~     The VALHUDES study is a Diagnostic Test Accuracy study that aims to document the clinical~     accuracy of hrHPV testing on urine samples, collected under standardised and optimised~     conditions, and on two types of vaginal self-samples and compare results with those from~     matching samples taken by a clinician.~   "
38397|NCT03064074|"~     Osteogenesis Imperfecta (OI) is a rare disorder that causes bones to break easily. People~     with OI may have broken bones with little or no trauma, dentinogenesis imperfecta (DI), and,~     in adult years, hearing loss. OI can range from very severe to very mild. The current~     standard-of-care for severe types of OI involves the use of IV medications (bisphosphonates)~     and surgery to put rods in bones to strengthen them. These therapies, although often~     life-saving, are new and very little is known about their long-term effects on bone and other~     body systems.~      Transforming growth factor beta (TGF-β) is a protein important in bone formation.~     Fresolimumab is an antibody that can silence TGF-β . In studies with mice with OI, it has~     been shown that silencing TGF-β can lead to higher bone mass, quality and strength. The~     purpose of this study is to determine if fresolimumab is safe in the treatment of OI.~   "
38398|NCT03064061|"~     The primary objective of this study is to evaluate the impact of a session of virtual reality~     (VR) with the objective of lowering the anxiety level on the clinical pregnancy rate~     following an In-vitro fertilisation (IVF) procedure. Indeed, anxiety in relation to~     infertility happens frequently and over time, can become stressful for our patients. This~     level of stress influences the effect of the infertility treatment. Reducing anxiety levels~     could promote the ability of the patients to face this stress and promote a greater chance of~     pregnancy in that context.~   "
38399|NCT03064048|"~     This is a study involving a dietary supplement. Patients with argininosuccinate lyase~     deficiency (ASLD) will be randomly assigned to receive either a nitric oxide dietary~     supplement or placebo for 24 weeks, and then crossed-over to receive the other treatment for~     24 weeks. The investigators will assess the effects of the supplement in domains of general~     cognition, memory, executive functioning, and fine motor functioning in individuals with~     ASLD.~   "
38400|NCT03064035|"~     The goal of this study is to determine if a fixed dose of 4-factor prothrombin complex~     concentrate (4FPCC) is as effective as the current standard of care. 4FPCC is used to reverse~     the effects of warfarin when a patient has emergent bleeding. The investigators hope that~     this study will help doctors treat patients quicker in the future. In addition, it may be~     cheaper for patients and hospitals. This is the same medication the doctor would use to~     reverse warfarin's effects, but at a lower dose.~      Hypothesis: A fixed dose of 4FPCC will be comparable to FDA-approved variable dosing for~     reversal of warfarin-induced anticoagulation (defined as an international normalized ratio~     [INR] ≤ 1.5) in patients with an INR ≥2 experiencing an emergent bleed or requiring emergent~     surgery.~   "
38401|NCT03064022|"~     The purpose of this study is to improve health professionals understanding of preterm infant~     growth patterns, and to determine if early growth patterns predict risks of adverse metabolic~     outcomes.~   "
38402|NCT03064009|"~     To determine if there is a relationship between people with open fractures and the season and~     location of where the injury occurred and the infections they develop~   "
39554|NCT03048942|"~     90 patients with HER2 negative breast cancer will be randomised to receive 18 weeks of~     chemotherapy treatment, either 6 cycles of 3 weekly Cabazitaxel or 6 cycles of weekly~     Paclitaxel to determine the difference in progression free survival between the 2 groups. If~     results at that stage suggest a potential benefit then the trial will be developed further to~     accrue 70 more patients.~   "
38403|NCT03063996|"~     The primary aim of this study is to determine if the insertion of a peripheral Internal~     Jugular (IJ) catheter is faster than a standard of care intravenous (IV)access in patients~     with difficult access. The secondary aims of this study examine patient discomfort between~     standard IV insertion vs. peripheral IV insertion as well as a comparison of complication~     rates between the two methods of insertion. Support for the peripheral IV procedure could~     provide an option for the thousands of Emergency Department (ED) patients who daily encounter~     the situation of difficult IV access and the numerous needle pokes that accompany it. Using~     this procedure may result in greater patient satisfaction and reduced complication rates.~   "
38404|NCT03063983|"~     Preclinical models show that a daily antiangiogenic regimen at low-dose may be effective~     against chemotherapy-resistant tumors. The aim of this study is to evaluate the efficacy of~     maintenance therapy with continuous oral cyclophosphamide and methotrexate in patients with~     high grade, operable, metastatic osteosarcoma (OST) of the extremities. The primary end point~     is event-free survival (EFS) from randomization~   "
38405|NCT03063970|"~     Stroke is the major cause of complex adult disability in the UK. Upper limb impairment~     contributes to disability and fewer than 15% of survivors regain full arm and hand function~     by 6 months. Consequently, many stroke survivors have difficulties with activities of daily~     living where good upper limb and hand function is required. Upper limb impairment also~     predicts quality of life and independent functioning after stroke. It is therefore vital that~     effective therapeutic interventions to improve upper limb recovery are found.~      Various therapeutic interventions to improve arm recovery after stroke have been proposed,~     however although effective in some circumstances, many have been proven as unacceptable and~     unfeasible in usual rehabilitation practice. The aim of this study is to evaluate the~     acceptability and feasibility of Dynamic Lycra Orthoses (DLO), as an adjunct to usual UL~     rehabilitation and to examine the magnitude, direction and variability of any effects on~     upper limb impairment and functioning.~      This inexpensive, commercially available, CE marked, tailor-made lycra sleeve garment is worn~     for up to 8 hours a day and during rehabilitation therapy. The DLO has not been extensively~     studies in stroke rehabilitation, but existing evidence suggests that the garment may enhance~     sensory feedback and correct upper limb movement and positioning, facilitating conditions for~     recovery without the need for direct therapist supervision. It may therefore augment the~     effects of standard dose of Occupational Therapy and Physiotherapy, and self-directed~     practice.~      This is a feasibility, randomised, controlled trial. Using 2:1 randomisation, We will recruit~     and randomise 60 participants with mild, moderate and severe UL impairment who have been~     admitted to Ninewells Hospital or Perth Royal Infirmary, Tayside, Scotland with a stroke~     affecting the upper limb to receive usual care or usual care plus the DLO. The DLO will be~     worn daily for up to 8 hours over 8 weeks. A blinded rater will collect outcomes data~     examining upper limb functioning, strength, dexterity, sensation, use of the arm for daily~     functioning and quality of life at the end of the intervention and at follow-up eight weeks~     later. Data relating to duration and frequency of DLO wear, proportion of eligible~     participants, and those willing to be randomised, drop-outs and losses to follow-up will also~     be recorded to assess feasibility of a full-scale trial.~   "
38406|NCT03063957|"~     The goal of this study is to establish a prospective observational cohort of adult patients~     with microscopic colitis and collect clinical information and specimens over the course of~     their treatment. This information will be used in order to establish a patient registry with~     detailed clinical data and a specimen repository for future research as well as to~     specifically identify genetic and molecular characteristics associated with microscopic~     colitis.~   "
38407|NCT03063944|"~     This phase I trial studies the side effects and best dose of STAT inhibitor OPB-111077 when~     given together with decitabine in treating patients with acute myeloid leukemia that does not~     respond to treatment or is newly diagnosed and ineligible for intensive chemotherapy. STAT~     inhibitor OPB-111077 and decitabine may stop the growth of cancer cells by blocking some of~     the enzymes needed for cell growth.~   "
38408|NCT03063931|"~     In breast cancer patients undergoing a mastectomy, the aim of this study is to evaluate if~     the magnesium administered for 6 weeks starting two weeks before the surgery induces a~     decrease of pain intensity one month post-mastectomy compared to the placebo group.~   "
38409|NCT03063918|"~     This pilot clinical trial studies how well personalized dietary intervention works in~     managing bowel dysfunction and improving quality of life in stage I-III rectosigmoid cancer~     survivors. Personalized dietary intervention may help people understand bowel symptoms,~     identify helpful and troublesome foods for bowel symptoms, adjust diets and food preparation~     based on food triggers, and coach on healthy diet recommendations after cancer treatment.~   "
38410|NCT03063905|"~     Evidence to support the effectiveness of ongoing opioid therapy for the treatment of chronic~     non-malignant pain is lacking. In fact, data suggest that patient outcomes improve when~     tapered off opioid analgesics. To better understand the role opioid therapy plays in the~     experience of pain, we will study measured pain sensitivity in opioid dependent patients over~     the course of and 3 months following a standardized opioid taper. By isolating the effect of~     opioid taper in patients without pain, preliminary evidence of effect size can be used to~     guide clinicians treating patients with chronic pain.~   "
38411|NCT03063892|"~     Tranexamic Acid (TXA) is an antifibrolytic medication used in total hip and knee arthroplasty~     to reduce the need for intraoperative and postoperative blood transfusions. Limited research~     is available on its use in hip fracture patients. We hypothesize that the use of TXA~     preoperatively, perioperatively, and postoperatively will decrease blood loss and need for~     blood transfusion postoperatively.~   "
38412|NCT03063879|"~     Sofosbuvir is the base of most treatment regimens for hepatitis C. In patients with renal~     failure the blood level of one of its metabolites (GS-331007) rises up to 20 folds. Although~     no particular adverse event has been linked to this metabolite sofosbuvir is not recommended~     for patients with renal failure mainly because of lack of data. Nevertheless there are~     anecdotal reports and small studies proving the safety of sofosbuvir in renal failure. This~     study addresses this lack of information by evaluating the safety and efficacy of sofosbuvir~     and daclatasvir in treating hepatitis C in 200 patients with renal failure.~   "
38413|NCT03063866|"~     Gastrointestinal endoscopy is a frequent procedure in the patients with advanced liver~     disease. It requires variable degree of sedation ranging from minimal sedation to general~     anesthesia aiming for relieving pain, anxiety, and bad memories of the procedure.~      In conscious sedation, patients are able to make purposeful responses to auditory and tactile~     clues, with maintenance of ventilatory and circulatory stability. while, in deep sedation,~     patients respond only to painful stimuli, and airway support is frequently required. At the~     level of general anesthesia, patients are unresponsive, and airway support is mandatory.~   "
38414|NCT03063853|"~     The optimal choice of skin closure at cesarean delivery has not yet been determined. This~     study aim to study the wound complications and scar healing after Surgical staples removal at~     postoperative day 4 and day 8 .~      A randomized control trial.~   "
40769|NCT03033069|"~     To evaluate the safety, efficacy and tolerability of brexpiprazole (with placebo) as~     monotherapy or combination therapy (Zoloft) in adults with PTSD.~   "
38415|NCT03063840|"~     Liver cancer including primary hepatocellular carcinoma (HCC) and metastatic liver cancers is~     one the most common malignancies in the world. Over 10000 new cases per year are diagnosed in~     Taiwan. Despite the many treatment options, the prognosis of HCC remains dismal. More than~     8000 people died of this cancer every year in Taiwan. A majority (70% to 85%) of patients~     present with advanced or unresectable disease. In contrast, small liver cancers can be cured~     with an appreciable frequency. Five-year disease-free survival exceeding 50% has been~     reported for surgical resection, and for the inoperable patients who do not have vascular~     invasion or extrahepatic spread. Radiofrequency ablation (RFA) is recommended as an~     alternative curative therapy. However, the main drawback of RFA is its limitation to tumor~     size and location. The tumors larger than 5 cm in diameter or located adjacent to vessels,~     could not be ablated completely sometimes. Microwave ablation (MWA) can ablate tumor by~     higher temperature than RFA, so is supposed not to be diminished by adjacent vessels.~   "
38416|NCT03063827|"~     This study investigated the changes in urothelial dysfunction and sensory protein expression~     in the bladder urothelium with time after onabotulinumtoxin injection in spinal cord injured~     (SCI) patients. The investigators planned to enroll 30 chronic SCI patient with neurogenic~     detrusor overactivity and urinary incontinence were treated with a single injection of 200 U~     onabotulinumtoxinA at the detrusor. Video urodynamic studies and bladder mucosal biopsies~     were performed at baseline, 3 months, and 6 months after treatment. Bladder tissues will be~     investigated for urothelial barrier and inflammation proteins as well as sensory proteins by~     Western blotting, between SCI patients and 10 controls, as well as successful and failed~     treatment groups. This study will explore the therapeutic efficacy of a single injection of~     200 U onabotulinumtoxinA on neurogenic detrusor overactivity and the changes of urothelial~     sensory proteins in SCI patients with successful and failed treatment outcome.~   "
38417|NCT03063814|"~     Therefore, the aim of the present study was to evaluate neuromuscular characteristics~     observed during a single bout of selected and validated injury preventive exercises~     instructed by an app (in accordance with 'Get set - Train smarter') versus gold standard~     instruction, supervision and feedback provided on-site by an expert. The present evaluation~     targets a population of female football and handball players without any previous exposure to~     injury prevention training.~   "
38418|NCT03063801|"~     Surgeries of heart disease in adulthood can happen in two specific contexts:~        -  either for an asymptomatic anomaly, possibly coupled with the onset of symptoms later in~          life and tardily diagnosed and surgically managed~        -  either for a malformation treated in childhood and requiring a new intervention in~          adulthood. In recent years, the number of adult patients with congenital heart disease~          has been steadily increasing. Advances in diagnostic techniques and surgical treatments~          have enabled many children to reach adulthood. The number of these patients is now~          higher than the number of children with congenital heart disease. The number of these~          patients having had surgery in adulthood is also increasing.~      Congenital cardiopathies are numerous, ranging from simpler pathologies such as~     inter-auricular or inter-ventricular communication, to much more complex pathologies such as~     situations of univentricular hearts. The surgical treatments of these congenital heart~     diseases are classified into three groups: initial palliative surgery, initial curative~     surgery or iterative surgery. Palliative surgery aims to improve the clinical tolerance of~     the patient to the conditions of his pathology or to prevent complications. The curative~     surgery restores the physiological circulation, the iterative surgery treats a complication~     or a degeneration appearing after a curative surgery.~      Patients undergoing cardiac surgery frequently receive blood products transfusions during the~     preoperative, intraoperative, or postoperative periods. Several observational studies have~     shown that in cardiac surgery, the transfusion of blood derivatives is associated with an~     increase in post-operative morbidity and mortality.~      The objective of this study is to analyze the predictive factors of transfusion in congenital~     patients operated in adulthood at Brugmann University Hospital, depending on the type of~     surgery applied (palliative, curative or iterative). The secondary objective will be to~     assess whether there are any differences with the predictive factors identified in~     non-congenital patients undergoing cardiac surgery, which could potentially alter the~     transfusion approach in congenital patients.~   "
38419|NCT03063788|"~     Radiolabelling broadly neutralizing anti-HIV antibody 3BNC117 with a Copper-64 radio isotope~     for infusion into people with HIV followed by MRI/PET scanning to detect HIV in vivo.~   "
38420|NCT03063775|"~     It is planned to evaluate if a porcine collagen matrix (Mucograft Seal) is offering~     comparable results to free gingival grafts (FGG) in post-extraction tissue preservation. If~     so, this would provide a substantial benefit to the patient as the second intervention on the~     palate and the subsequent morbidity of the donor site is omitted.~   "
38421|NCT03063762|"~     This is an open-label, multi-center, randomized, Phase 1b, adaptive, clinical study to assess~     the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary therapeutic~     activity of RO6874281 in combination with atezolizumab with/without bevacizumab in~     participants with unresectable advanced and/or metastatic RCC. The study will consist of~     dose-escalation part and extension part.~   "
38422|NCT03063749|"~     To observe the continued performance of the Medtronic Resolute Onyx™ Zotarolimus-Eluting~     Coronary Stent System in a real-world more-comer population.~   "
38423|NCT03063736|"~     The primary objective of this pilot study to evaluate the safety of low dose Entolimod in~     normal, healthy, non-patient normals. This clinical trial in 40 normal humans compares a~     single dose of 4 ug Td (2 ug of TT and 2 ug of diphtheria toxoid + 3000 ug of alum with or~     without entolimod. Subjects will be randomized to: Td alone (n=15) and Td+ entolimod (n=25).~     The investigators expect that Td + entolimod will double the anti-TT and anti-diphtheria AB~     levels over Td alone.~   "
38424|NCT03063723|"~     Recently,surprisingly and unexpectedly increased aggressiveness and high rates of HCC~     recurrence (28%(16/58) and 29%(17/59), respectively) have been reported in patients who~     cleared HCV with DAAs after achieving a complete response to resection or local ablation~     within only 6 months of therapy. The authors hypothesized that the rapid eradication of HCV~     and control of liver inflammation would impact anti-tumoral immune control, which in turn~     might contribute to the neoplastic cells proliferation. Conversely, three independent~     prospective French cohorts failed to reveal an increased risk of HCC recurrence after DAAs~     treatment in CHC patients after receiving curative cancer treatments.Although the impact of~     DAAs treatment on the rate of HCC occurrence or recurrence still remain unclear, it would be~     more important to pay attention to the immunological changes of CHC patients treated with~     DAAs.Up to now, little was known about the immunological changes of chronic hepatitis C (CHC)~     patients treated with direct-acting antiviral agents (DAAs), here we try to explore the~     effect of antiviral treatment of CHC patients with DAAs on the frequency of monocytes, NK~     cells and cytokines that promote their activation.~   "
38560|NCT03061955|"~     The objective of this study is to evaluate the safety and efficacy of concurrent~     administration of influenza vaccine in patients receiving anti-PD1 immunotherapy (nivolumab~     or pembrolizumab). This will be a prospective observational study, aiming to assess patient~     tolerance of treatment, adverse events (incidence, grade, need for hospitalization),~     incidence of influenza infections, and seroconversion rates.~   "
38425|NCT03063710|"~     This is a single-arm, open label, expanded access program to provide access to olaparib~     tablets for relapsed high-grade epithelial ovarian cancer patients (including patients with~     primary peritoneal and / or fallopian tube cancer) with BRCA mutations (documented mutation~     in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious [known or~     predicted to be detrimental/lead to loss of function]) who have responded following platinum~     based chemotherapy.~      Patients may continue to receive study treatment until disease progression as assessed by the~     investigator according to local standard clinical practice or any other discontinuation~     criteria are met.~   "
38426|NCT03063697|"~     The purpose of this study is to Evaluate the Safety of DILATREND SR Cap. in Korean Patients~     with Essential hypertension, Chronic stable angina and Congestive heart failure for 52 weeks.~   "
38427|NCT03063684|"~     The study will examine the effects of fractional/pixel CO2 laser treatment in vaginal atrophy~     and in vulvar lichen sclerosus by means of histological and immuno-histochemical~     characterization of the epithelial layers and markers of tissue aging. The tissue~     characterization will be performed by biopsies of the vaginal or vulvar tissue at three~     different points of time: prior to treatment, two weeks after the third and last treatment,~     and one year after the last treatment.~   "
38428|NCT03063671|"~     This study investigate the effect of addition dexmedetomidine, ketamine or their combination~     to bupivacaine in thoracic epidural analgesia on acute postoperative pain after breast cancer~     surgery.~   "
38429|NCT03063658|"~     This study will evaluate two different analgesic regimen used for acute postoperative pain.~   "
38430|NCT03063645|"~     To compare serum ketone body (i.e., total ketones, β hydroxybutyrate, and estimate of~     acetoacetate) levels after single dose administration of AC-1202 and 2 doses of AC-SD-01.~   "
38431|NCT03063632|"~     This phase II trial studies how well pembrolizumab and interferon gamma-1b work in treating~     patients with stage IB-IVB mycosis fungoides and sezary syndrome that has come back or has~     not responded to previous treatment. Monoclonal antibodies, such as pembrolizumab, may~     interfere with the ability of cancer cells to grow and spread. Interferon gamma-1b may boost~     the immune system activity. Giving pembrolizumab and interferon gamma-1b together may work~     better in treating patients with stage IB-IVB mycosis fungoides and sezary syndrome.~   "
38432|NCT03063619|"~     This randomized phase II trial studies how well afimoxifene works in reducing the risk of~     breast cancer in women with mammographically dense breast. Estrogen can cause the growth of~     breast cancer cells. Hormone therapy using afimoxifene may fight breast cancer by blocking~     the use of estrogen by the tumor cells.~   "
38433|NCT03063606|"~     This study will test the effectiveness of cognitive-behavioral therapy as a specialist~     treatment for binge eating disorder (BED) in patients with obesity. This is a controlled test~     of whether, amongst non-responders to acute treatments, cognitive-behavioral therapy augments~     on-going blinded pharmacotherapy (either naltrexone/bupropion or placebo), compared with no~     additional behavioral treatment .~   "
38434|NCT03063593|"~     Study Title UK Post-Market Clinical Follow-Up Of The INFINITY® Total Ankle System Study~     Design Prospective, multi-site, multi-year post-market clinical follow-up study Study Group~     Primary/Unilateral and/or bilateral Total Ankle Arthroplasty subjects implanted with~     INFINITY® Total Ankle System Number of Subjects 500 with 10 sites~   "
38435|NCT03063580|"~     Primary Objective:~      To evaluate the effects of rifampicin on the pharmacokinetics (PK) of sotagliflozin and its~     metabolite in healthy male and female subjects.~      Secondary Objectives:~        -  To assess total 24-hour urinary glucose excretion (UGE) after a dose of sotagliflozin~          400 mg, alone and with rifampicin, in healthy male and female subjects.~        -  To assess the safety and tolerability of single dose sotagliflozin with and without~          rifampicin in healthy male and female subjects.~   "
38436|NCT03063567|"~     Obstructive sleep apnea (OSA) is a prevalent disease, and one that is associated with~     significant negative impact on long-term survival. There is convincing evidence that~     treatment of OSA can improve outcome in patients with cardiovascular disease, improve blood~     pressure and blood glucose control, and improve the overall metabolic syndrome. Treatment is~     usually with continuous positive airway pressure (CPAP). However, many patients face problems~     with their CPAP interfaces, affecting their compliance and response to treatment. Proper mask~     fit is important in decreasing air leak and increasing comfort, thus leading to better~     compliance. Currently, the choice of interfaces depends mainly on the experience of the sleep~     disorder unit (SDU) technicians. Unsuitable choice of interface not only affects response to~     treatment but also increases medical costs when interfaces need to be replaced to better~     fitting ones. It is thus important to develop selection criteria to objectively guide the SDU~     technicians in choosing the suitable interfaces. The objective of this study is to study the~     facial profile of patients and look for predictive indices that can be used to objectively~     guide the choice of appropriate interfaces. Frontal and side profile photographs of patients~     will be taken and facial measurements will be recorded. Patients will then be given a one~     monthly trial of each of the 3 interfaces (nasal masks, oronasal masks, nasal cushions) in a~     randomised order. The patients' subjective perception of each of the interface will be~     assessed and patients will nominate their preferred interface at the end of the trial. The~     amount of leak and the hours of adherence for each type of interface will also be analysed. A~     multinomial logistic regression analysis will then be done to look for facial measurements~     that will predict the interface that patients will be most satisfied with.~      Hypothesis That measurement of facial structures and clinical features will be able to~     predict the best-fit CPAP interface for each patient.~      Study Objective~        -  To determine anthropometric facial measurements and clinical factors important in~          achieving a good interface fit for each patient~        -  To derive a prediction rule or equation that will be able to accurately predict which~          interface a patient should be prescribed~   "
38437|NCT03063554|"~     This Endoscopic Ultrasound guided Biliary Drainage (EUS-BD) vs. Endoscopic Retrograde~     Cholangiopancreatography (ERCP-TP) trial (BILPAL) is a randomized controlled multicenter~     trial that will provide evidence whether or not traditional ERCP biliary drainage is to be~     performed in patients with obstruction in bile duct due to unresectable pancreatic head or~     periampullary tumor.~   "
38438|NCT03063541|"~     Purpose of this study is to assess the hypothesis that a strategy with acetylsalicylic acid~     (ASA) 100 mg/day, intensive blood pressure treatment (targeted systolic blood pressure below~     120 mmHg), and a blood pressure measuring device reduces the risk of aneurysm rupture or~     growth compared with standard care (i.e. no ASA, blood pressure management according to~     standard blood pressure management, no blood pressure measuring device)~   "
38466|NCT03063177|"~     This study evaluate the relationships between spinal manipulative therapy dosage (speed and~     peak force), the resulting modulation of thoracic spinal stiffness and changes in the~     clinical status in participants with chronic thoracic pain. Participants will attend four~     sessions of one hour over 2 weeks. During session 1 to 3, participants will receive one of~     three different spinal manipulative therapy dosages based on their group assignment and~     preceded and followed by the measurement of their thoracic spinal stiffness. Session 4 will~     include spinal stiffness measurement and clinical status evaluation through questionnaires.~   "
38439|NCT03063528|"~     This proposal is part of a broader research agenda that posits healthy gestational weight~     gain (GWG) may be achieved through behavioral intervention and may potentially reduce adverse~     maternal and infant health outcomes associated with excessive weight gain during pregnancy.~     The purpose of this study is to examine the use of a mobile application (mobile app) and~     mobile website for encouraging and maintaining healthy behaviors such as healthy eating,~     regular exercise, and stress management and reduction during pregnancy. The study will~     include collaborative group-based health behavior challenges for pregnant women living in the~     United States. The study will test the effectiveness of the intervention on improving~     maternal health behaviors. The proposed research project will examine if an intervention~     targeting healthy eating and exercise leads to significantly less weight gained during~     pregnancy versus a comparison group that receives stress reduction and management content.~   "
38440|NCT03063515|"~     The investigator will examine the effect of a single dose of pyridostigmine, AchE inhibitor~     on insulin secretion in healthy subjects. Each subject will undergo an intravenous glucose~     tolerance test (IVGTT) where IV glucose will be administered and the glucose excursion and~     insulin secretion response will be evaluated by measuring insulin and glucose at different~     time points. The test will be carried out twice, once without and once with the~     administration of a single dose of Pyridostigmine on two separate days. The investigator~     hypothesizes that inhibiting AChE will potentiate insulin secretion.~   "
38441|NCT03063502|"~     This study evaluates how urine handling conditions can affect the concentrations of ~1,000~     urine metabolites and attempts to quantify the degree of attenuation and/or potential bias in~     epidemiologic associations that may result from less than optimal sample handling conditions.~   "
38442|NCT03063489|"~     Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat~     Ocular Instillations of Loteprednol Etabonate Ophthalmic Gel, in Normal Healthy Volunteers~   "
38443|NCT03063476|"~     This sub-study aims to assess the effect and breakdown of lysine administration, specifically~     examining whether it leads to increased plasma 2-AAA in healthy humans.~   "
38444|NCT03063463|"~     Currently there are no existing data to determine why some achalasia patients lose weight~     while others do not. The purpose of this study is to gather data from patients diagnosed with~     achalasia to determine if differences may be identified between those who lose weight and~     those who do not that would help us better understand the mechanism of weight loss in this~     population.~   "
38445|NCT03063450|"~     The UK has the highest incidence of mesothelioma. The incidence has risen by 497% since the~     late 1970's and is increasing worldwide due to continued mining and use of asbestos. For~     patients with mesothelioma who have relapsed after taking pemetrexed and cisplatin, there is~     currently no standard treatment, making this an urgent unmet need. Recent trials in this area~     have not found an effective treatment that improves overall survival.~      Following a debate in the House of Lords, a national survey assessing the research priorities~     in mesothelioma found that 'exploiting the potential of immunotherapy' was a top priority.~     This trial was designed in response to that survey. It uses the immunotherapy agent nivolumab~     which blocks programmed cell death 1 (PD-1) receptor on activated T-cells (a type of white~     blood cell forming part of the immune system). Early research has found a dependency of~     mesothelioma on the PD-1 checkpoint. By attaching to PD-1, nivolumab blocks its action~     (checkpoint inhibition), preventing it from turning off the T-cell, and therefore allowing~     the immune system to work. PD-1 checkpoint inhibition has revolutionised the treatment of~     melanoma and it is hoped to be as effective in mesothelioma.~      This trial is a randomised, double blind placebo controlled trial of patients with~     mesothelioma who are third relapse following a platinum based chemotherapy treatment.~     Patients will be randomised in a 2:1 ratio (nivolumab: placebo).~      336 patients will be recruited from 25 UK centres over a four-year period with the last~     patient having a minimum of 6 months follow up. All patients will be on treatment for 12~     months unless they progress or withdrawal prior to this. Clinic visits will occur every 12~     weeks, mirroring standard care. Data following progression will be obtained from the NHS~     Information Centre.~   "
38446|NCT03063437|"~     The objective of this study is to provide preliminary insight into the safety and efficacy of~     fecal microbiota transplantation (FMT) for the eradication of gastrointestinal carriage of~     vancomycin-resistant Enterococcus.~   "
38447|NCT03063424|"~     The diagnosis of exercise-induced bronchospasm (EIB) is difficult. The metacholine challenge~     test is not enough specific for the diagnosis of EIB. The exercise challenge test on a cycle~     ergometer is often use to diagnose this condition. This test has very high specificity, but~     not enough sensibility because the ventilation achieved during this test is often not big~     enough to induce a bronchospasm, especially in trained athletes. Eucapnic voluntary~     hyperventilation (EVH) is the recommended test of the Olympic National committee to establish~     the diagnosis of EIB, but there are no study comparing the sensibility and specificity of the~     cycle ergometer challenge test and the isocapnic hyperventilation in an establish population~     of asthmatics. The investigators assume that the sensitivity and specificity of EVH are~     higher than those of the cycle ergometer for the diagnosis of EIB in a population of~     asthmatics with symptoms suggestive of bronchospasm on exertion. In a population of~     asthmatics with exercise symptoms, what is the sensitivity and specificity of EVH and~     exercise challenge on a cycle ergometer for the diagnosis of EIB?~   "
38448|NCT03063411|"~     This study will test whether a short training program - designed to improve memory and~     attention skills - will benefit mathematical reasoning in preschoolers from a range of~     socio-economic backgrounds. The investigators will test how long any benefits last for and~     whether any intervention effects are greater for children from disadvantaged backgrounds. The~     aim is to test interventions that aim to close the achievement gap by improving skills known~     to underpin academic skills, at an age children may benefit most from training.~   "
38449|NCT03063398|"~     This study is a proposed a comprehensive prospective assessment of exocrine pancreatic~     insufficiency (EPI), nutritional status, and quality of life (QOL) during the early~     re-feeding phase, at 3 months, and 12 months following an AP attack.~   "
38467|NCT03063164|"~     Comparing LASIK outcomes using two femtosecond lasers~   "
38561|NCT03061942|"~     The purpose of this study is to assess the effect of synovectomy on clinical outcomes of~     arthroscopic rotator cuff repair.~   "
38450|NCT03063385|"~     Latino adolescents are at high risk for HIV/AIDS, other sexually transmitted infections~     (STIs), and unintended pregnancies. Puerto Rican adolescents, in particular, experience~     disparities in these areas, yet few adolescent and even fewer parent interventions have been~     developed to address these important issues with this underserved population.~     Parent-adolescent programs are an effective approach to reduce adolescent sexual risk~     behavior and associated negative consequences. A web-based parent communication intervention~     provides an opportunity to strengthen and enhance programs that are designed for adolescents~     by providing additional support for safer sex decisions, and to increase parents' access to~     sexual health education programs by decreasing barriers that keep them from participating in~     these interventions (e.g., low cost, can be viewed privately, at parents convenience,~     minimizes competing time with work and family). The purpose of this proposed study is to~     evaluate a brief theoretically informed (i.e., Ecodevelopmental Theory, Theory of Reasoned~     Action/Planned Behavior, Social Cognitive Theory 1-6), culturally appropriate, and~     linguistically tailored web-based parental communication program, Cuídalos (Take care of~     them), designed to improve parent-adolescent sexual communication and reduce adolescent~     sexual risk behavior. Recent findings from an NIH funded R21 randomized control trial (RCT)~     testing a brief computer-based version of the Cuídalos program indicated that the program~     increased parent-adolescent general communication and sexual risk communication with English~     and Spanish speaking U.S. Latinos. Further, despite limited or no previous computer use,~     parents reported they liked and learned from the program, and that it was easy to use and~     accessible.~   "
38451|NCT03063372|"~     Medical students and residents have high rates of mental distress and burnout related to the~     intellectual and time demands of their training. Research shows that physiological stress on~     the body can be a result of fatigue and high stress work, and is associated with experiences~     related to mental distress. Pomegranate is a fruit that is known to contain a variety of~     antioxidant substances that can reduce physiological stress. This study will look at the~     potential for pomegranate supplementation to reduce physiological stress and improve~     well-being in medical students and residents.~   "
38452|NCT03063359|"~     Acute tramatic pain is one of main reasons for consultation in pediatric emergency~     departments.~      To manage pain quickly and effectively must be a primary outcome of the emergency department.~     However, pediatric emergency department are sometimes criticized for inadequate and delayed~     initiation analgesia . Indeed, several studies have shown the inadequacy between the~     intensity of the pain evaluated by the care team and the therapeutic management of it.~      The ideal analgesic must have a rapid onset of action, have a powerful analgesic effect, have~     few side effects and can be administered quickly and painlessly. That's why, the main outcome~     of this study is to assess the non inferiority of a treatment by intranasal Fentanyl vs~     morphine sulfate (oral use) in children with traumatic pain on arrival to pediatric emergency~     department.~   "
38453|NCT03063346|"~     Overtraining is a real problem for (semi-)professional athletes. Overtraining is often caused~     by the bodies' lack of ability to recover between training. In addition, during high~     intensity training reactive oxygen species are formed up to 20 fold compared to resting~     values. This causes increased muscle tissue damage after intense exercise, which slows down~     recovery. Improving recovery may increase an athlete's ability to reach higher training~     volumes resulting in establishing a higher performance plateau.~      It is known that hydrolyzed proteins have a positive effect on muscle protein synthesis due~     to its faster absorption rate. Therefore, it is hypothesized that a known protein hydrolysate~     may have positive effects on strength recovery.~   "
38454|NCT03063333|"~     Coping-oriented hypnotic suggestions aimed at reducing pain catastrophizing was shown to~     reduce pain in people with chronic tension-type headache and experimental pain in healthy~     volunteers during hypnosis (Kjøgx et al., 2016). However, the duration of the effect on pain~     post-hypnosis is unknown.~      The aim is to investigate the durational effect of a single session of coping-oriented~     hypnotic suggestions on chronic pain in patients with spinal cord injury. If effective for a~     longer period post-hypnosis, this form of hypnosis may provide an alternative to medicine or~     may be used in conjunction with lower medicine dosages.~      Methods: 75 patients with spinal cord injury and pain is randomized into one of three~     conditions; coping-oriented hypnosis plus current treatment, neutral hypnosis plus current~     treatment or current treatment only. Pain intensity, coping strategies, pain catastrophizing,~     anxiety and depression is assessed before intervention and over a period of 14 days~     post-intervention.~   "
38455|NCT03063320|"~     A 3-period randomized cross-over, controlled feeding study will be conducted to determine the~     effect of chronic spice consumption on postprandial vascular function. Participants will~     consume three test diets containing different amounts of spice. Each treatment period will~     last for 4 weeks. After each diet period a meal test will be conducted. Participants will~     consume a meal with a spice content corresponding to the diet period they have just~     completed. Endothelial function will be measured at 2 and 4 hours after meal consumption.~     Blood samples will also be taken during the 4 hours after meal consumption for measurement of~     lipids, immune and inflammatory markers.~   "
38456|NCT03063307|"~     The present study aims to evaluate, through a controlled clinical randomized study,the~     effectiveness of silver diamine fluoride in arresting dentin caries lesions in primary molars~     when compared to atraumatic restorative treatment.~   "
38457|NCT03063294|"~     The Coordination Toolkit and Coaching (CTAC) project aims to disseminate strategies for~     coordination of care for high-risk Veterans via an online toolkit, while evaluating the~     benefits of adding a distance-coaching strategy to assist sites with deploying the toolkit's~     tools. The project's focus is on care coordination across outpatient settings.~      This multi-site project provides: 1) An online toolkit to support better care coordination~     for vulnerable patients visiting primary care, 2) Random assignment of participating clinics~     to either a toolkit or a combined toolkit/distance coaching strategy, and 3) A quality~     improvement approach with plan-do-study-act cycles of improvement, designed to support~     clinics in a locally initiated effort.~      The project is recruiting clinics with the goal of improving Veteran experience of care (as~     measured by a survey called the Hassles Scale), communication and coordination between~     primary care providers and specialists, and use of acute care services.~   "
38458|NCT03063281|"~     Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by the~     production of multiple autoantibodies. The prevalence and significance of antibodies against~     Ficolin-2 have not been yet investigated. The aims of this study were to determine the~     prevalence of anti-ficolin-2 antibodies among SLE patients and to investigate their potential~     as diagnostic and/or prognostic biomarkers in SLE.~      This study is a secondary phase of a serum sample analysis done in early 2015 in order to~     determine the prevalence of anti-ficolin-2 antibodies among the same cohort as the previously~     declared study (ClinicalTrials.gov ID: NCT02625831; Unique Protocol ID: 1841851v0).~      In this retrospective study, clinical data were obtained from medical files and blood samples~     were selected from preexisting biological collection. SLE patients (n=165) were informed and~     did not objected, they were matched to healthy controls (n=48). Disease activity was~     determined according to the SLEDAI score. Anti-ficolin-2 antibodies levels were measured in~     sera by ELISA and correlated to previously obtained Anti-ficolin-3, Anti-ficolin-2,~     anti-dsDNA and anti-C1q antibodies levels.~      The titer of anti-ficolin-2 antibodies was correlated with the SLEDAI score (p<0.0001). The~     presence of anti-ficolin-2 antibodies was associated with anti-ficolin-3 antibodies, anti-C1q~     and anti-dsDNA antibodies.~      Interestingly, the combination of anti-ficolin-3, anti-ficolin-2 and anti-C1q antibodies~     demonstrated higher specificity than any other traditional biomarker.~      These results suggest that anti-ficolin-3 and anti-ficolin-2 antibodies could be useful for~     the diagnosis of active nephritis in SLE patients.~   "
38459|NCT03063268|"~     The goal of this project is to develop and evaluate a novel, electronic informed consent~     application for research involving electronic health record (EHR) data. In response to NIH~     RFA-OD-15-002, this study addresses research using clinical records and data, including the~     issues of the appropriate content and duration of informed consent and patient preferences~     about research use of clinical information. This study will design an electronic consent~     application intended to improve patients' satisfaction with and understanding of consent for~     research using their EHR data. The electronic application will provide interactive~     functionality that creates a virtual, patient-centered discussion with patients about~     research that uses EHR data. Also, to correct potential misconceptions and increase~     informedness, the application will present trust-enhancing messages that highlight facts~     about research regulations, researcher training, and data protections. This study (Specific~     Aim 2 of the linked study protocol) will compare the effectiveness of the interactive,~     trust-enhanced consent application to an interactive consent and standard consent (no~     interactivity, no trust- enhancement) using a randomized trial of the three consents with 750~     adults in a network of family medicine practices. Primary outcomes will be satisfaction with~     the consent decision and understanding of the consent content. This application will allow~     patients to learn more about clinical research and make informed choices about whether or not~     they want their health records and data to be used for research. This first phase of this~     project (IRB#:201500678) was innovative because it created a virtual, patient-centered~     discussion about research using EHR data. Moreover, this project produced a consent~     application that clinicians and researchers will use in this phase (Phase two) of the trial~     as an ethically sound and practical tool for consenting patients, in a clinical setting, for~     research involving EHRs. Overall, this study will improve understanding of how to best give~     patients information about research that uses their health records and data. With this~     understanding, this study will develop a new computer application that patients can use in~     their doctors' offices. This application will allow patients to learn more about clinical~     research and make informed choices about whether or not they want their health records and~     data to be used for research.~   "
38460|NCT03063255|"~     Patients diagnosed with posterolateral bladder tumors will be invited to participate in the~     study. Subjects will be randomized to receive an ultrasound-guided obturator block or a~     neuromuscular blocking agent after the induction of general anesthesia in an attempt to block~     the obturator reflex during surgery.~   "
38461|NCT03063242|"~     The study will determine whether administration of sargramostim will improve myeloid~     dendritic cell deficiency in various study groups, including healthy subjects and patients~     with chronic kidney disease, including those with kidney transplants.~   "
38462|NCT03063229|"~     Islet transplantation may be appropriate in up to 10% of adults with Type 1 diabetes who~     suffer repeated episodes of hypoglycaemia with severely impaired awareness of hypoglycaemia~     (IAH) (1). Our Scotland-wide islet transplant programme performed its first transplant in~     February 2011 and 30 islet transplants have followed in 18 recipients. Following islet~     transplantation we have observed improved glycaemic control in all subjects. When metabolic~     control is improved with exogenous insulin, weight gain is common (2). In our transplant~     recipients significant reductions in bodyweight and fat mass with no significant reduction in~     total caloric intake pre- versus post-transplantation has been observed. We hypothesise that~     energy expenditure is increased post-transplantation leading to weight loss and diminished~     fat mass. The mechanisms that may be implicated include increased activity energy~     expenditure, increased resting energy expenditure (REE) and, or, increased post-prandial~     thermogenesis (PPT= the energy expended after a meal) secondary to increased portal~     circulation of insulin being partially or fully restored, and diminished circulating systemic~     insulin concentrations with a decreased propensity for storing fat. The aim of this study is~     to understand the mechanism of weight loss and body compositional changes by detailed~     examination of energy intake and energy expenditure in transplant recipients along with~     control subjects listed for insulin-pump therapy and glucose tolerant controls. These~     detailed studies are lacking in islet transplantation and are important as they will reveal~     how physiology is altered post-transplantation, if peripheral hyperinsulinaemia (insulin-pump~     subjects and pre-transplant subjects) negatively affects energy expenditure and how~     quantitative measures such as activity energy expenditure, diet and quality-of-life measures~     such as fear of hypoglycaemia alter post-transplant. This will lead to the improved~     management of patients with hypoglycaemia and IAH.~   "
38463|NCT03063216|"~     The purpose of this study is to evaluate the long-term visual outcome of the cataract surgery~     using a large-scale and comprehensive database of pediatric cataract patients, including~     congenital and traumatic cataract. We will further investigate into the various genetic and~     environmental factors that may contribute to the pathogenesis of pediatric cataract.~   "
38464|NCT03063203|"~     In this study, the investigators seek to determine whether decitabine therapy can improve~     outcomes, specifically overall survival this selected subset of acute myeloid leukemia (AML)~     patients with the poorest prognosis based on refractoriness to induction treatment and high~     risk genetic mutations.~   "
38465|NCT03063190|"~     Restless leg syndrome (RLS) is sleep disorder characterized by an unpleasant feeling in the~     lower limbs, which can be accompanied by paresthesias, and need for urgent movement of the~     legs. Its diagnosis is clinical, based on an International Committee of the Study of RLS~     (International Restless Legs Syndrome Study) questionnaire. Its prevalence is about 5-15% in~     the general population, being twice as frequent in women and with a tendency to increase~     incidence with aging. In the chronic kidney disease (CKD) population, mainly in patients on~     dialysis, the prevalence increases by up to 70%. Vitamin D deficiency is associated with RLS~     and active vitamin D supplementation seems to improve RLS and severity. It is seems, studies~     on the role of vitamin D supplementation in CKD population are missing. The~     clinical-scientific hypothesis of this study is that replacement of vitamin D~     (cholecalciferol) will improve the symptoms of RLS. As parathyroidectomy can relieve RLS, the~     aim of researchers is to randomize patients with CKD on dialysis to receive cholecalciferol~     or placebo in 2 distinct groups: secondary hyperparathyroidism and adynamic bone disease.~   "
38497|NCT03062774|"~     This is an open label, multiple dose study, pharmacokinetic and pharmacodynamics studies will~     be performed at the same time with tolerability study. Three dose arms are designed, 12~     subjects will be enrolled in each arm, will equal number of males and females.~   "
38583|NCT03061656|"~     The purpose of this study is to evaluate the efficacy and toxicity of tandem HDCT/ASCT~     including high-dose 131I-metaiodobenzylguanidine (MIBG) treatment. In the present study, a~     single arm trial of tandem HDCT/ASCT will be carried out.~   "
38468|NCT03063151|"~     The aim of the study is to investigate the capacity of post-stroke individual (study group)~     to modulate their EMG muscle activation pattern (MAP) compared to healthy individuals~     (control group), and to correlate these capacities with their motor impairments. Twenty~     post-stroke individuals and 12 healthy individuals will participate in this study. each~     participant will carry out hand-reaching movements in multiple directions, monitored by an~     EMG device. The modulation of the EMG signal will be compared between groups in terms of~     EMG-MAP and in terms of muscle-synergies. Additionally the MAPs and synergies of the study~     group will be correlated with their Fugl-Meyer (FM) assessment scores. Analysis of the muscle~     synergies underlying the EMG signal will be carried out by the Non-negative Matrix~     Factorization (NMF) algorithm.~   "
38469|NCT03063138|"~     The aim of the study is to evaluate the intra- and inter-rater variability of wound~     measurements using the 3D camera and to compare with standard measurement methods (2D image~     method and gel injection). Forty-eight patients with wounds of various sizes are measured by~     four clinicians. Each wound is measured twice with the 3D camera, once by 2D image method and~     once by gel injection into wound cavity by two clinicians.~   "
38470|NCT03063125|"~     The purpose of this study is to examine the relationship between testosterone level changes~     around the time of radical cystectomy.~   "
38471|NCT03063112|"~     The study compares between the efficacy, safety and impact on the quality of life of~     radiofrequency thermocoagulation and chemical neurolysis of bilateral thoracic splanchnic~     nerves in the management of refractory pain which developed in patients suffering from upper~     abdominal cancer.~   "
38472|NCT03063099|"~     A pilot study to evaluate changes in hip function and pain in patients with osteoarthritis~     receiving the ReNu™ Hip Injection.~   "
38473|NCT03063086|"~     The purpose of this study is to assess peak FEV1 of two doses of QVM149 compared to a~     fixed-dose combination of salmeterol/fluticasone (50/500μg b.i.d.) and to characterize the~     respective 24 hour bronchodilator effect profiles in patients with asthma. Data from this~     study will complement lung function data obtained in the pivotal QVM149 phase 3 program by~     assessing the bronchodilatory effect of QVM149 at multiple time-points over an entire dosing~     interval of 24 hours.~   "
38474|NCT03063073|"~     The Pecs block (pectoral nerves block) is an easy and reliable superficial block inspired by~     the infraclavicular block approach and the intercostal abdominis plane blocks . Many~     additives were used in combination with local anesthetics in Pecs block to prolong the~     postoperative analgesia (fentanyl, dexmedetomidine).~   "
38475|NCT03063060|"~     Post-operative hypocalcaemia following total thyroidectomy is a well-known complication and~     becoming a major area of research.~      Many factors are assumed to increase the incidence of post-thyroidectomy hypocalcaemia, but~     the impact of vitamin D deficiency remains uncertain.~      Since results so far were inconclusive, the goal in this study is to significantly determine~     the relation between those two factors.~      This study is the first to deal with this issue through patients who underwent total~     thyroidectomy that was performed by the same surgeon and the same surgical technique.~      A retrospective evaluation study of patients who underwent total thyroidectomy at the head~     and neck unit of the Otorhinolaryngology department at our institution between January 2013~     and October 2016.~      A total number of 60 patients underwent total thyroidectomy with available vitamin D levels~     before surgery, as well as pre and post-operative PTH and calcium levels.~      Pre-operative vitamin D and PTH levels were checked within a maximum of one month duration~     before surgery.~      All patients were operated by the same surgeon -Dr. Galit Avior-, with the same surgical~     technique.~      The study involves access to the patients files and admission reports. In addition the~     investigators would like to be able to call the patients in order to ask them whether Vitamin~     D deficiency was corrected or not before their surgery, and If it was corrected then when~     exactly.~   "
38476|NCT03063047|"~     This study will evaluate exposure to tar and nicotine from two menthol cigarette products~     and provide a basis for comparing mouth-level exposure when smokers smoke the two cigarette~     products. Mouth-level exposure is the measurement of substance trapped in the cigarette butt~     after smoking the cigarette.~      Other purposes of this study are to:~        -  Compare the plasma cotinine, a byproduct of your body's processing of nicotine, levels~          found in users after smoking each of two different cigarettes.~        -  Find out the daily mouth-level exposure to cigarette tar and nicotine from smoking~          each of two different cigarettes in adult smokers.~        -  Determine if certain measures of nicotine dependence change based on the type of~          cigarette smoked~        -  To compare product liking and intent to use it again.~   "
38477|NCT03063034|"~     This study will evaluate exposure to tar and nicotine from two menthol cigarette products~     and provide a basis for comparing mouth-level exposure when smokers smoke the two cigarette~     products. Mouth-level exposure is the measurement of substance trapped in the cigarette butt~     after smoking the cigarette.~      Other purposes of this study are to:~        -  Compare the plasma cotinine, a byproduct of your body's processing of nicotine, levels~          found in users after smoking each of two different cigarettes.~        -  Find out the daily mouth-level exposure to cigarette tar and nicotine from smoking~          each of two different cigarettes in adult smokers.~        -  Determine if certain measures of nicotine dependence change based on the type of~          cigarette smoked~        -  To compare product liking and intent to use it again.~   "
38517|NCT03062514|"~     Children with refractory epilepsy who are candidates for a treatment with vagus nerve~     stimulation will be prospectively randomized into 2 arms. Vagus nerve stimulation parameters~     are programmed and adjusted during outpatient clinic visits, within the normal clinical~     practice.~   "
38518|NCT03062501|"~     This study will investigate the safety, tolerability and potential for the use of up to three~     daily doses of 30-40 mg/kg HU (daily) upon hospitalization for painful vaso-occlusive crises~     .~   "
38519|NCT03062488|"~     The purpose of this study is to compare the incidence of EA in pediatric patients undergoing~     minor ENT surgery under Sevoflurane and compare opioid-only based intra-operative analgesia~     to multi-modal analgesia consisting of opioid and IV acetaminophen or PO acetaminophen~     regimen using a validated and standardized EA measurement tool, the Pediatric Anesthesia~     Emergence Delirium (PAED) scale. The post operative pain scores will be measured in all~     patients by post-op recovery staff using FLACC Score/Wong-Baker FACES (patients 24 months up~     to 7 years of age) or Numeric Pain Score for patients 7 years of age. The pre-operative,~     surgery, anesthesia and post-operative staff will be all blinded.~   "
38478|NCT03063021|"~     Retinitis Pigmentosa (RP) is a devastating eye disease and at present there are no known~     treatment options that can alter the rate of vision loss. In a series of studies in animal~     models, the effects of exposing cones in the periphery of the retina to a large excess of~     oxygen results in progressive oxidative damage to cone photoreceptors and cone cell death.~     Compared to control patients, those with RP showed significant reduction in the reduced to~     oxidized glutathione ratio (GSH/GSSG) in aqueous humor and a significant increase in protein~     carbonyl content. This demonstration of oxidative stress and oxidative damage in the eyes of~     patients with RP, suggests that oxidative damage-induced cone cell death in animal models of~     RP may translate to humans with RP and support the hypotheses that (1) potent antioxidants~     will promote cone survival and function in patients with RP and (2) aqueous GSH/GSSG ratio~     and carbonyl content on proteins provide useful biomarkers of disease activity in this~     patient population. Orally administered N-Acetylcysteine (NAC) has been found to be a~     particularly effective antioxidant that promotes prolonged cone survival and maintenance of~     cone function in a mouse model of RP. There is good rationale to test the effect of NAC in~     patients with RP. The first step is to do test different dosing regimens to identify the~     lowest dose that is able restore aqueous GSH/GSSG ratio and reduce carbonyl adducts on~     aqueous proteins.~      In patients with Idiopathic Pulmonary Fibrosis, polymorphisms within the TOLLIP gene were~     found to influence outcomes of NAC-treated patients. The product of the TOLLIP gene,~     toll-interacting protein, is an inhibitory adaptor protein downstream of toll-like receptors,~     mediators of innate and adaptive immunity. The identification of the influence of TOLLIP~     polymorphisms on the effect of NAC in Idiopathic Pulmonary Fibrosis provides rationale for~     collecting DNA and genotyping the same single nucleotide polymorphisms (SNPs) in the current~     trial. In addition to this candidate gene genetic analysis, patient RNA will be collected and~     banked for future transcriptome analysis. The rationale for this is to identify gene~     expression changes that modify disease progression in RP. There is substantial variability in~     rate of progression among patients with RP. A patient who loses all vision early in life can~     have a sibling with the same mutation who maintains vision into advanced age. This suggests~     that modifier genes can have a major impact on cone survival. This study will test the~     hypothesis that the level of expression of gene products that contribute to the antioxidant~     defense system may influence cone cell death and hence the rate of loss of visual field. It~     is also possible that gene expression differences may contribute to differences in response~     to NAC. For these reasons collecting RNA samples from patients will allow next generation~     sequencing in the future to understand the transcriptome background on which the study~     intervention has been performed.~   "
38479|NCT03063008|"~     Clinical outcome with regard to oswestry disability index and lumbar fusion rate after~     implantation of titanium coated PEEK cage and common PEEK cage~   "
38480|NCT03062995|"~     With the rising prevalence of allergic diseases and the subsequent risk of developing other~     immune-related disorders, primary prevention of allergy has become a major priority. It is~     generally acknowledged that breastfeeding is one of the main pillars in allergy prevention.~     Infant formulas based on hydrolysed proteins have been developed to be used by infants at~     increased risk of developing allergy in case a mother is unable or chooses not to breastfeed~     her infant. The effect of hydrolysed formula in allergy prevention has been examined in many~     studies, from which it can be concluded that currently there is not sufficient evidence to~     support hydrolysed protein over intact protein for allergy risk reduction. Moreover, several~     clinical trials support the suggestion of supplementation of pre and/or probiotics for the~     reduction of eczema development, recognized by international authorities. The present study~     (MAESTRO) investigates the preventive effect of a hypoallergenic concept combining several~     nutritional approaches related to preventive strategies: partially hydrolysed protein formula~     supplemented with prebiotics and probiotics. The aim of the present study is to investigate~     the efficacy, growth and safety of this concept compared to standard (intact protein) infant~     formula on the development of allergic manifestations up to the age of 12 months in infants~     at increased risk of developing allergy.~   "
38481|NCT03062982|"~     This study evaluates the food-effect of one-dose Fluzoparib in healthy subjects. The~     participants receive Fluzoparib 120mg in fed state in Period 1 followed by administration of~     Fluzoparib 120mg in fasted state in Period 2.~   "
38482|NCT03062969|"~     Shortly after the implementation of Comprehensive Chromosome Screening (CCS) techniques for~     Preimplantation Genetic Screening (PGS) came the transition in biopsy timing. Trophectoderm~     biopsy is meant to overcome the limitations of cleavage stage biopsy and single cell~     analysis.~   "
38483|NCT03062956|"~     Up to 72 healthy volunteers will be given a single dose of MYK-491 or placebo and be~     monitored for safety and tolerability over a 7 day period.~   "
38484|NCT03062943|"~     This trial is conducted locally. The aim of this trial is assess the efficacy and a favorable~     benefit-risk ratio for nintedanib in the treatment of LAM at the dose of 150 mg bid~   "
38485|NCT03062930|"~     Stroke survivors with severe contralesional paresis often have substantial control and~     coordination deficits in the non-paretic arm. Because this arm must serve as the primary~     controller, these deficits can be functionally devastating. The investigators now hypothesize~     that the combination of severe paresis (Upper Extremity Fugl-Meyer Score ≤35) and persistent~     motor deficits in the non-paretic arm limits functional independence in chronic stroke~     survivors. The investigators predict that remediation, focused on the non-paretic arm should~     improve functional independence. The investigators propose a randomized study design with two~     tracts, two periods and four assessments. The investigators envision this study as the first~     step in establishing the basis for a rehabilitation approach that focuses on remediation of~     BOTH arms, which constitutes a substantial change from current remediation protocols focused~     only on the contralesional arm.~   "
38486|NCT03062917|"~     This study will compare the novel methods of NS and BS with the standard technique of~     nasophayngeal aspiration (NPA) and routine ETT suction. We shall assess the samples for~     diagnosis of RSV, viral load and immune responses in the airways of babies with RSV~     infection. We shall also assess the genetics of babies included in this study, to see if they~     may be vulnerable to RSV infection.~   "
38487|NCT03062904|"~     There exists a physiological limitation of the expiratory flows because of the physical~     properties of the bronchial tree (flexible bronchial walls in a complex architecture~     subjected to variations of pressure and volume). For a given lung, in a given state, for each~     pulmonary volume there is a corresponding Maximum Expiratory Flow (MEF). In healthy subject,~     the bronchial smooth muscles have a basal tonicity which is not negligible. If the tonicity~     is increased, this generally leads to a reduction in MEF. If it is decreased, MEF rather~     tends to increase, there are healthy individuals for whom the inhibition of the contraction~     of the bronchial smooth muscles by inhalation of bronchodilatator leads to a reduction in the~     MEF: this is called paradoxical effect. When this reduction exists, it appears it occurs at~     low pulmonary volumes (approximately 50% for a volume of less than 25% of the CV). Under this~     circumstance, it seems that the basal tonicity of the bronchial smooth muscles would fight~     against the expiratory collapse of the bronchi, and this would happen especially for distal~     bronchi, for low pulmonary volume and for forceful expiration. The existence of such a~     phenomenon would be in favour of a stiffening role of the bronchial smooth muscles. The~     bronchial smooth muscles would not be only harmful cells causing of the asthma attacks.~   "
38488|NCT03062891|"~     Insomnia occurs frequently causing a substantial burden to society (1). Historically,~     insomnia has been considered as secondary to a handful of other psychiatric disorders, such~     as depression and anxiety - but it is now clear that this disorder is associated with a wide~     range of psychiatric conditions and may actually precede and predict their development and~     severity (e.g. 2). Treating insomnia has been posited to hold the promise of reducing or~     preventing the development of co-morbid problems - although this possibility needs to be~     rigorously tested.~      Cognitive behavioural therapy (CBT) is an effective treatment for disturbed sleep,~     specifically insomnia, in adults (3) and is recommended by NICE for the management of~     long-term sleep problems. This treatment is more accessible than ever before given recent~     ground-breaking internet initiatives - such as the Sleepio programme (see:~     https://www.sleepio.com/home/), which was developed by one of the collaborators (Colin Espie)~     and has yielded encouraging results (4).~      Despite the importance of CBT for treating disturbed sleep and the finding that it leads to a~     good outcome for the majority of sufferers, some people fail to respond to this treatment.~     For example, research cited on the Sleepio website notes that around 70% of those with even~     very long term sleep difficulties experience long-term improvements from the treatment,~     meaning that 30% do not (see 4). Understanding more about who does and does not respond holds~     the promise of improving or tailoring treatments for insomnia.~      The study proposed here builds on recent work by one of the researchers who has been~     exploring demographic (5), clinical (e.g. 6) and most uniquely genetic (e.g. 7); and~     epigenetic (e.g. 8) predictors of psychological treatment response (coining the term~     Therapygenetics, see, 7). While these predictors are individually only likely to explain a~     small proportion of the variance of treatment outcome, understanding these multiple risks and~     their interaction is the best way to consider this issue. The study addressed here is a pilot~     study, necessary to demonstrate feasibility of utilising a sleep intervention application in~     an unselected sample of young adults, prior to applying for grant funding to undertake a~     larger but similar behavioural genetics study in the future.~      The main aim of this pilot study is to test the feasibility of the study design, by~     investigating whether unselected participants show an improvement in sleep quality after~     taking the intervention. Participation and drop out rates as well acceptability of the~     intervention in a non-clinical population will also be investigated.~      Research Questions:~        1. Does the online CBT intervention improve sleep quality in a non-clinical, unselected~          sample?~        2. How feasible is it to run this study on a non-clinical sample? This will include~          investigating response rate, participant drop-out, and treatment accessibility.~           The investigators will also offer perform preliminary investigations into:~        3. Does improving sleep quality have implications for associated phenotypes? Specifically~          the investigators will examine symptoms of anxiety, depression, attention-deficit~          hyperactivity disorder (ADHD), psychosis, and well-being.~        4. Which demographic, clinical, genetic, and epigenetic factors predict treatment outcome~          for sleep problems?~      Research questions 3) and 4) will be primary aims in the main study, but will constitute~     secondary aims in the pilot study as there won't be the statistical power to fully address~     these questions.~   "
38489|NCT03062878|"~     The overall goal of this project is to determine the effects of anti-cancer chemotherapy on~     reflex control of blood pressure and vascular function. Recent data have demonstrated that~     cardiovascular disease-related mortality is the 2nd cause of morbidity and mortality for~     7-year cancer survivors treated with chemotherapy. This anti-cancer treatment-mediated~     cardiotoxicity is a progressive process that begins at the molecular level, progresses to~     myocardial injury and left ventricular dysfunction, cumulating as heart failure and~     cardiovascular disease-related mortality. In parallel to these cardiac-specific changes,~     chemotherapy has also been shown to increase the risk for vascular-related abnormalities.~     However, the impact of adjuvant treatments on the function and structure of the peripheral~     vascular system remains poorly understood. With normal aging, two of the most important~     vascular adaptations to arteries, which strongly contribute to the increased risk of~     vascular-related and general cardiovascular disease, are an increase in large artery~     stiffness and dysfunction of the vascular endothelium. Therefore, the overall goal of this~     project is to determine the effects of anthracycline-based chemotherapy on large and small~     artery function and structure. The central hypothesis is that this type of cancer therapy~     results in negative vascular consequences as determined by non-invasive evaluation of~     spontaneous blood pressure control, carotid artery stiffness, and vascular~     endothelium-dependent vasodilation.~      This observational study is designed to increase our understanding of the vascular changes~     that occur during and following anti-cancer chemotherapy and provide insight into new methods~     that will decrease cardiovascular disease risk in those treated for cancer.~   "
38490|NCT03062865|"~     Rheumatoid arthritis (RA) is a complex and multifactorial autoimmune disease. The biological~     treatments that are currently available for the treatment of RA are the TNF-alpha inhibitors.~     Tumor necrosis factor (TNF) is a dominant cytokine in the inflammatory process of rheumatoid~     arthritis. The anti-TNFs were the first to enter the market, and they revolutionised the~     prognoses of patients with RA. They remain the most common first-line biotherapy and are the~     most used at this time.~      The French Society of Rheumatologists intends to coordinate a prospective national registry~     study for this follow-up.~      This registry will include 1500 RA patients from the start of treatment with anti-TNF-α and~     then followed for 5 years, regardless of the therapeutic modifications occurring thereafter.~      This registry is an observational, multicentre, longitudinal, prospective registry study The~     objectives of this registry is to contribute 1) to evaluate the therapeutic management of~     patients; and 2) to improve this therapeutic management.~   "
38491|NCT03062852|"~     Serious medication administration errors are common in hospitals and nurse's interruptions~     during medication preparation and administration is associated with errors. Various~     interventions were developed to help prevention of errors such as visual intervention.~     Investigators aimed to study the effect of a medication safety vest to reduce medication~     errors. The vest serves as a visible signal to inform others that the nurse is preparing and~     administering medications and should not be disturbed. Patients and visitors are provided~     with an informational flyer to inform them about the use of medication safety vests.~      The hypothesis is that the vest will reduce nurse's interruptions during medication~     preparation and administration, and ultimately reduce medication errors.~      The study is a randomized controlled trial in 30 care units of four hospitals in France. Each~     unit will be randomized in either the control group or the experimental group using the~     medication safety vest. Nurses of the unit will be selected at random to determine who will~     be observed during the administration rounds.The observation method will be used to evaluate~     the error rates in the 2 groups. The number of interruptions and error rates will be~     evaluated.~   "
38492|NCT03062839|"~     This study aims to evaluate the effect of melatonin supplementation as adjuvant treatment in~     ADHD in adults.~   "
38493|NCT03062826|"~     This protocol describes a perspective,multicenter study intended to test the hypothesis that~     patients with STEMI caused by plaque rupture or plaque erosion without obstructive stenosis~     (diameter stenosis <70%) can be stabilized by effective antithrombotic treatment without~     stent implantation, thereby avoiding both early and late complications related to~     percutaneous coronary intervention (PCI).~      Patients with STEMI within 12 hours will be included for screening. Thrombus aspiration will~     be performed in patients with large thrombus burden and TIMI flow grade less than 2 to~     restore blood flow. OCT will be used to assess the underlying mechanism including plaque~     rupture, erosion, calcified nodule, and other uncommon reasons.~   "
38494|NCT03062813|"~     This study was to evaluate the efficacy and safety of Tacrolimus combined with entecavir~     antiviral therapy for HBV-associated glomerulonephritis in china. Tacrolimus combined with~     entecavir rapidly and effectively induced remission of HBV-GN in Chinese adults. Meanwhile,~     Tacrolimus may have a synergistic antiviral effect with entecavir. The study protocol was~     reviewed and approved by Guangdong General Hospital's Ethic Committee, and all participants~     provided written informed consents. The study will be a prospective,~     randomized,controlled,single-blind, multi-centre, withdrawal study conducted by Guangdong~     general hospital, Guangdong Academy of Medical Sciences.there will be two phases, phase 1,~     Screening and enrolling 112 HBV-GN patients about one year,and phase 2, ongoing follow-up for~     24 weeks.The data of all patients will be recorded in the HBV-GN electronic database.Before~     the randomisation, All patients will receive entecavir routine antiviral therapy for two~     weeks.And then they will be randomized to two different group,the treatment group: Tacrolimus~     combined with entecavir antiviral therapy,the control group: The Tacrolimus placebo and~     entecavir antiviral therapy. The Tacrolimus target trough concentration was 5-10 ng/mL during~     the therapy. The primary outcome variables were the number of patients who reached complete~     or partial remission (CR or PR) after the 25 week-treatment. CR was deﬁned as <0.3 g/24 h~     proteinuria (UPCR<300mg/g.cr) or lower plus stable renal function (eGFR>50 ml/min/1.73 m2)~     and PR as proteinuria 0.3-3.0 g/24 h (UPCR 300-3000mg/g.cr) and 50% lower than baseline~     proteinuria plus stable renal function. Secondary outcome variables: 1) The number of~     patients who reached complete or partial remission (CR or PR) after the 13 week-treatment. 2)~     Serum creatinine (SCr) increased 2 times the baseline levels or 50% lower than the baseline~     eGFR(according to chronic kidney disease-EPI (CKD-EPI) )after the 25 week-treatment. 3)Serum~     HBV DNA was undetectable(HBV DNA<500copies/ml) at the end of 25 week-treatment. 4) The number~     of patients who present acute kidney injury at the end of 25 week-treatment.~   "
38495|NCT03062800|"~     The study for innovative strategies is warranted in the treatment of advanced non-squamous~     NSCLC with epidermal growth factor receptor wild-type or unknown mutation status because the~     outcomes remain unsatisfactory for most patients. Maintenance treatment after first-line~     chemotherapy is a very interesting strategy that has been largely investigated in the last~     years. This study is to evaluate the efficacy and toxicity of thalidomide in combination with~     chemotherapy and as maintenance treatment in patients with advanced non-squamous NSCLC.~   "
38496|NCT03062787|"~     It is a post-license, multicenter, randomized, single blind, controlled study comparing a~     single injection of Cingal® (study arm) with a single injection of Monovisc® (control arm).~   "
38584|NCT03061643|"~     Study of Biweekly Docetaxel plus Androgen-Deprivation Therapy (ADT) in Patients with~     Previously-Untreated, Metastatic, Prostatic Adenocarcinoma~   "
38498|NCT03062761|"~     It is universally accepted that the best nutrition for a new-born infant is breast milk.~     Breast milk provides a complete set of nutrients to support growth and development of~     children in early life, including components that have a beneficial effect on gut health and~     the body's ability to defend itself against infectious organisms and other invaders (immune~     system).However, it may occur that a mother is unable to breastfeed her child, or chooses not~     to breastfeed. In such cases, an infant formula inspired by breast milk is the best~     alternative. Research is done to optimize milk formula for infants. One of these formulas~     contains 'partially hydrolyzed' proteins instead of intact proteins, meaning the proteins in~     this formula are broken down into smaller pieces. These smaller pieces of protein make the~     milk more suitable for consumption by infants at risk of developing cow's milk allergy. These~     types of partially hydrolyzed protein formulas have been on the market for several years, in~     particular for children with a family risk of allergy. So far, no safety related issues have~     been reported. It is also known that weight gain of infants receiving partially hydrolyzed~     proteins in general is appropriate according to the World Health Organisation growth~     standards.~      The main purpose of the TENUTO study is to demonstrate that infants who receive a specific~     partially hydrolyzed protein infant formula for the first 4 months of life have a similar~     weight gain compared to infants receiving standard infant formula with intact proteins. A~     group of infants who receive breast milk only is also included for comparison.~   "
38499|NCT03062748|"~     The purpose of the study is to compare the relative contribution of systemic inflammation vs.~     Obstructive Sleep Apnea (OSA) severity (as measured by Apnea Hypopnea Index) in predicting~     cardiovascular and metabolic aberrations associated with mild-to-moderate obstructive sleep~     apnea.~   "
38500|NCT03062735|"~     This study is a randomized controlled trial on the efficacy of inspiratory muscle training on~     swimming performance, airway dysfunction and perceived breathlessness in elite swimmers.~   "
38501|NCT03062722|"~     Prospective controlled clinical trial in which a minimally invasive microsurgical approach~     was used following the keyhole principle in 55 patients and 65 hands under local anesthesia~     and ambulatory strategy. All patients included in the study had an average of 3 months~     disease course and were considered refractory to conservative treatment. Patients were~     evaluated with stringent inclusion criteria with the Levine severity and functional status~     scale with a 2 year follow-up. Descriptive outcomes on the efficiency of this procedure are~     reported.~   "
38502|NCT03062709|"~     This study aims to assess the feasibility of using an intervention for environmental smoke~     exposure in children that uses cotinine testing results with written materials and telephone~     counseling for a potential future study of parents whose children are admitted with~     respiratory illnesses to The Barbara Bush Children's Hospital in Portland, Maine.~   "
38503|NCT03062696|"~     The primary aim of this study is to pilot cognitive behavioral therapy (CBT-RD) for 10~     individuals ages 10 and older who have rumination disorder~   "
38504|NCT03062683|"~     The investigators compared the serum lactate, serum prolactin and serum creatine kinase~     concentrations following convulsive and non-convulsive syncopes. The aim of the study was to~     investigate their importance as diagnostic markers in transient loss of consciousness.~   "
38505|NCT03062670|"~     Through this research we intend to evaluate whether a team-based care delivery approach using~     daily huddles is effective in improving caregiver and patient outcomes in primary care~     setting. This approach is expected to not only lead to effective primary care delivery~     outcomes, but also result in greater team morale, reduced burnout, and a higher rate of~     innovation.~   "
38506|NCT03062657|"~     This clinical study will assess the metal concentrations present in the blood serum of~     patients who receive surgical treatment with the PRESTIGE LP™ Cervical Disc at two contiguous~     cervical levels from C3-C7. The information obtained from this clinical investigation will be~     used to support the post market surveillance for a PMA supplement for the PRESTIGE LP™~     Cervical Disc implanted at two contiguous levels.~   "
38507|NCT03062644|"~     The MR308-3502 study is a multicenter double-blind, randomised, placebo- and active~     comparator-controlled study in female subjects to evaluate the efficacy and safety of MR308~     with acute pain after TAH or STAH (total or subtotal abdominal hysterectomy).~   "
38508|NCT03062631|"~     Congenital myasthenia and LEMS are potentially lethal disorder, which, even with careful~     management, significantly impedes participation in normal daily functions. Currently approved~     therapies have had little impact on promoting a normal quality of life activity in these~     patients. The goal is to systematically examine the effect of 3,4-DAP on the natural course~     of this disease and to gain additional experience in titrating 3,4-DAP with other available~     therapies to maximize clinical function and development in this patient population.~      The specific aim of this study is to evaluate the use of 3,4 Diaminopyridine (DAP) on~     selected patients proven by genetic or serum antibody testing to have Congenital Myasthenic~     Syndrome (CMS) or Lambert-Eaton Myasthenic Syndrome (LEMS). We will evaluate the patient for~     CMS or LEMS, prescribe 3,4 DAP, and then clinically evaluate the response.~   "
38509|NCT03062618|"~     This study consists of three parts: single oral dose escalation in healthy volunteers (Part~     A), and multiple oral dose escalations in healthy volunteers (Part B) and in participants~     with chronic plaque psoriasis (Part C)~   "
38520|NCT03062475|"~     Gestational diabetes mellitus(GDM) is a commom complication during pregnancy and associated~     with various adverse pregnancy outcomes for both the mother and her offspring. Imoportantly,~     with the gradual opening of a two-child policy, more and more Chinese women of reproductive~     age enter pregnancy have a history of GDM. Our previous study showed that regular exercise~     commenced in early pregnancy is effective in reducing the risk of developing GDM in Chinese~     overweight and obese pregant women. Thus, in this study, we want to evaluate the effect of~     lifestyle intervention with detailed information on how to eat and how to diet in preventing~     the recurrence of GDM.~   "
38557|NCT03061994|"~     This study aims to 1)characterize the differentially expressed metabolites between~     cardiomyopathy patients and healthy controls,2)identify the specific biomarkers associated~     with outcomes or risk evaluation in patients with different cardiomyopathies in a follow-up~     of a cohort and 3)to determine whether differentially expressed may affect the pathological~     process of cardiomyopathies . Standardized protocols will be used for the assessment of~     medical history and examinations, laboratory biomarkers, and the collection of blood plasma.~   "
38510|NCT03062605|"~     The purpose of the study is to determine the effect of a two-step mouth rinsing procedure on~     reducing the germs (mutans Streptococci) that cause tooth decay. We hope that the two-step~     mouth rinse (0.3% NaOCl followed by 10% Povidone Iodine) decreases the tooth causing germs~     better than the one-step mouth rinse (10% Povidone Iodine). The mouth rinse for both~     treatment groups is done only once at the beginning of the study after the initial saliva~     samples are taken, and before a detailed examination of the teeth and gums. It is~     hypothesized that the treatment group receiving the NaOCl and Povidone iodine will have~     significantly lower microbial counts than the control group (Povidone iodine) because the~     NaOCl will disrupt the microbial biofilm and make the Povidone iodine more effective in~     decreasing the microbes in the biofilm. Microbial counts are made from Salivary samples taken~     from participants at baseline, one week, one month, two months and three months. The samples~     are tested by two commercial methods for determining microbial counts. The CariScreen Test is~     a rapid bioluminescence assay that quantitates the total number of all of the organisms~     present. The CRT test requires a culture media that is specific for the two germs (S. mutans~     and Lactobacillus) strongly associated with tooth decay. The results of the CRT Test are read~     after three days of incubation.~   "
38511|NCT03062592|"~     Several free fatty acids receptors (FFARs) have been discovered. These have been implicated~     in metabolic processes and inflammation. Consequently, these receptors have attracted~     interest as targets for the treatment of metabolic and inflammatory diseases, including~     obesity and T2D. Two of these FFARs (FFAR1, FFAR4), which is activated by specific free fatty~     acids (FFAs), is expressed on enteroendocrine cells, pancreatic beta-cells and adipocytes.~     They have been linked to 1) increased GLP-1 secretion and hence the incretin-mediated~     increase in glucose-stimulated insulin secretion (GSIS) and suppression of glucagon~     secretion, 2) a direct positive effect on GSIS, 3) reduced inflammation and 4) improved~     insulin sensitivity. These functions and the abundance of fatty acids in food suggests that~     FFARs can be considered as nutrient sensing regulators of metabolism. Roux-en-Y gastric~     bypass (RYGB), frequently results in immediate beneficial effects on glucose metabolism and~     often complete remission of T2D. This may in part be explained by increased GLP-1 levels~     after surgery. It appears that the effect depends on nutrient delivery directly to the lower~     parts of the small intestine. It is possible that the RYGB effects are partly due to~     enteroendocrine stimulation of FFAR1 and perhaps FFAR4 by direct nutrient delivery, i.e. FFA~     release in the lower intestines. Pinolenic acid from pine nuts has been shown to be a potent~     dual FFAR1/FFAR4 agonist.~      Based on these findings we have planned a number of human intervention studies in order to~     investigate 1) the optimal oral formulation of pine nut oil 2) whether we can mimic the~     beneficial effects observed after RYGB, 2) if we can increase meal-related GLP-1 secretion by~     stimulating FFAR1/FFAR4 on enteroendocrine cells causing improved GSIS and increased satiety~     and 3) enhancement of GSIS by directly stimulating FFAR1 (and perhaps FFAR4) on beta-cells.~   "
38512|NCT03062579|"~     Neuromyelitis Optica Spectrum Disorder (NMOSD) is a severe inflammatory disease of the~     central nervous system characterized by relapsing optic neuritis and longitudinal extensive~     transverse myelitis. The specific autoantibody against aquaporin 4 (AQP4-ab) has been~     suggested to contribute to the pathogenesis of the disease. Peripheral blood plasma cells are~     a major source of AQP4-ab. Previous studies have observed increased IL-6 levels in serum and~     cerebrospinal fluid of patients with NMOSD, particularly during relapses. Exogenous~     interleukin (IL)-6 promotes the survival of plasma cells and their production of AQP4-ab in~     vitro. And blockade of IL-6 receptor signaling by an anti-IL-6 receptor antibody reduces the~     survival of plasma cells in vitro. Tocilizumab (ACTEMRA®), a humanized monoclonal antibody~     against the IL-6 receptor, has shown beneficial clinical effects in some patients with NMOSD~     when concomitant immunosuppressive medications were administered. However, the long-lasting~     biological effects of preceding immunotherapies such as rituximab might overlap with the~     subsequent tocilizumab therapy. To reduce the side effects of concomitant treatments to large~     extent and verify the beneficial effects of tocilizumab, we evaluate the safety and efficacy~     of tocilizumab as monotherapy in patients with NMOSD.~   "
38513|NCT03062566|"~     The PreTBI III study aims to investigate the prognostic potential of prehospital and repeated~     in-hospital S100B, NSE and GFAP measurements as predictors of neurological outcome in~     patients suffering severe TBI. Knowledge on prehospital S100B, GFAP and NSE levels as~     predictors of neurological outcome and mortality may underline the potential of a~     point-of-care analysis. Possibly, the early biomarker levels may contributed to accurate~     monitoring of biomarker dynamics and hereby support neurosurgeons and anaesthetists in the~     clinical decision-making regarding treatment and level of care offered to the patient.~      Hypotheses:~        1. Prehospital S100B level is a significant predictor of unfavourable neurological outcome~          (dichotomized disability rating scale (DRS) and glasgow outcome scale extended (GOS-E)~          measures) in severe TBI patients.~        2. Prehospital GFAP level is a significant predictor of unfavourable neurological outcome~          (dichotomized DRS and GOSE measures) in severe TBI patients.~        3. Prehospital NSE level is a significant predictor of unfavourable neurological outcome~          (dichotomized DRS and GOSE measures) in severe TBI patients.~        4. combined panel of prehospital S100B, GFAP and NSE levels is a significant predictor of~          unfavourable neurological outcome (dichotomized DRS and GOSE measures) in severe TBI~          patients.~        5. Unfavourable neurological outcome (dichotomized DRS and GOSE measures) in severe TBI~          patients can be predicted by dynamics in repeated measurements of S100B, GFAP and NSE.~   "
38514|NCT03062553|"~     The proposed study aims to use a form of neuromodulation, known as transcranial alternating~     current stimulation (tACS), to improve the effectiveness of the metacognitive training (MCT)~     program for treatment of delusions in schizophrenia. tACS is a non-invasive brain stimulation~     method utilizing weak electrical currents applied to the head to influence neural firing~     (Antal & Paulus, 2013). Brain regions implicated in delusional thinking will be targeted in~     the hopes of promoting thinking patterns that will allow participants to question delusional~     beliefs, reducing the severity of delusions and increasing the positive effects of MCT~     (Whitman et al., in press; Whitman, Minz & Woodward, 2013). Electroencephalogram (EEG) and~     behavioural assessments will be used to measure treatment effects.~   "
38515|NCT03062540|"~     This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose~     study that will investigate the efficacy and safety of 5.6 mg TNX-102 SL (2 x 2.8 mg~     tablets)—a sublingual formulation of cyclobenzaprine. Following successful screening and~     randomization, eligible patients will have a telephonic visit at week 2 and then return~     regularly to the study clinic for monthly visits for assessments of efficacy and safety.~   "
38516|NCT03062527|"~     The purpose of the present study was to assess the influence of low vs moderate glycemic~     index of a 3-week diet on aerobic capacity, endurance performance and body mass and~     composition in endurance-trained athletes in a randomized, controlled crossover trial.~   "
38585|NCT03061630|"~     Previously-untreated, high-risk (>T3 and/or N+) muscle-invasive bladder cancer (MIBC)~     cisplatin 60 mg/m2 on day 1 and gemcitabine 1000 mg/m2 on days 1, 8 and 15. On day 1~   "
38521|NCT03062462|"~     With the widespread use of clopidogrel, resistance to clopidogrel has been attracting~     increasing attention, and emerged as a new challenge adversely affecting patients clinical~     risk and outcome. Clopidogrel resistance means that blood platelets show little or no~     response to clopidogrel. It is closely associated with increased risk of serious~     cardiovascular events, seriously affects the prognosis of patients, and brings difficulties~     to clinical treatment.~      Guideline recommendations on the use of dual antiplatelet therapy have been formulated that~     ticagrelor 90 mg twice daily plus aspirin in preference to clopidogrel 75mg daily plus~     aspirin for ACS patients. Recent study found that ticagrelor 90mg twice a day orally could~     significantly reduce the occurrence of clopidogrel resistance and adverse cardiovascular~     events. The previous studies have reported that half-dose ticagrelor had the similar~     inhibitory effect on platelet aggregation as the standard-dose ticagrelor, which was~     significantly stronger than that in the clopidogrel group. But it is still not very clear~     that the effect of low-dose ticagrelor on platelet function in patients with clopidogrel~     resistance and coronary heart disease.~      Therefore, we performed this randomized, single-blind clinical trial to observe the effects~     of low-dose ticagrelor and double standard-dose clopidogrel on platelet aggregation and~     prognosis in clopidogrel resistance's patients with coronary heart disease.~   "
38522|NCT03062449|"~     This is a Phase IIa, randomized, double-blind, placebo controlled trial. Subjects for~     participation in this study will be identified by the Investigator based on their Clinical~     Dementia Rating score which will be completed as part of standard practice. Patients meeting~     the criteria for early Alzheimer's disease will be considered for study participation, with~     the Investigator taking the additional inclusion/exclusion criteria into consideration. Up to~     40 subjects will be enrolled. Subjects participating in the study will be randomized to~     receive either gummies containing L-Serine or placebo gummies, with the Investigator and~     study staff blinded to the group assignments.~   "
38523|NCT03062436|"~     Patients with chronic myeloid leukemia (CML) are conventionally put on life long therapy with~     tyrosine kinase inhibitor drugs (Imatinib mesylate in India). Patients who achieve a deep~     molecular response which has been sustained for at least three years, can be taken off the~     drug therapy. Thereafter a close monitoring is required to monitor their disease relapse. In~     case there is evidence of disease recurrence on highly sensitive molecular assays, their drug~     therapy is restarted. The study aims to identify proportion of patients who can be kept off~     drug therapy in a state of sustained molecular remission.~   "
38524|NCT03062423|"~     Comparative randomized, single dose, three way three sequence two treatment partial replicate~     crossover open-label study to determine the bioequivalence of Sofosbuvir from Sofodelevier~     400 mg F.C.T (Al-debeiky pharma, Egypt) versus Sovaldi 400 mg Tablets (Gilead Sciences,~     Canada)~   "
38525|NCT03062410|"~     Physician mainly use RECIST progression-free survival (PFS) and NCI CTCAE safety as a guide~     to evaluate treatment efficiency. In contrast Health Related Quality of Life (HRQOL)~     assessment is often restricted to clinical trial. It could be of particular interest to~     evaluate HRQOL in daily clinical practice in order to adequately choose and manage first line~     therapy, especially since HRQOL at diagnosis was shown to be a prognostic factor of overall~     survival in advanced or metastatic renal cell carcinoma (mRCC). A systematic collection in~     daily clinical practice of the HRQoL data using standardized questionnaires could strengthen~     management of symptoms : improve symptom control, improve patient-clinician communication,~     satisfaction with care and well-being of the patient and in fine the overall survival.~      The objective of the QUANARIE Study is to assess the feasibility of HRQOL assessment in daily~     clinical practice for patients with mRCC treated with tyrosine kinase inhibitor (TKI) using~     electronic patient reported outcome (PRO).~      Indeed, the goal is to make the HRQoL data accessible and exploitable in real time to~     clinicians, to help medical professionals to optimize their practices by adopting a holistic~     and personalized approach based on patient reported outcomet.~   "
38526|NCT03062397|"~     Clinical Trial to Evaluate the Efficacy and Safety of JPI-289 in Patients With Acute Ischemic~     Stroke~   "
38527|NCT03062384|"~     The purpose of this study is to evaluate if the use of a yeast-selenium supplement (AT-001)~     is safe in elderly subjects who do not have dementia, and further, to see if the supplement~     improves tests that are related to brain health.~   "
38528|NCT03062371|"~     Play encourages the development of a child's social and cognitive skills. Playgroups are~     interactive environments that facilitate these developmental abilities and provide~     opportunities for parents to engage with their children. A lack of play can have negative~     effects on a child's development and may result in a decline in social participation.~      Objective: The purpose of this research is to investigate if children between the ages of 15~     months and 5 years old demonstrate improved levels of playfulness, social- emotional growth,~     and participation through playgroup intervention, provided in various settings in the~     community. Investigators will also examine the impact that these playgroups have on~     participating caregiver's confidence levels in regards to their abilities in taking their~     child/children on outings in the community.~      Method: A quasi-experimental stepped-wedge design with one way cross-over will be used. This~     study will look at the effectiveness of all playgroups, and then determine differences in the~     three groups: 25 pairs will be in a control standard of care early intervention playgroup, 25~     pairs will take part in a occupational therapy led playgroup,and 25 pairs will be~     participating in a standard of care early intervention playgroup with additional occupational~     therapy support. The control site will be the same site as the support playgroup (cross-over,~     wait-list). The Test of Playfulness will measure child playfulness, the Social Profile and~     Assessment of Preschool Children's Participation play sub scale will determine child~     participation, the Devereux Early Childhood Assessment will determine social emotional~     growth, and the Parenting Sense of Competence Scale will determine the caregiver sense of~     competence. Mean differences will be analyzed using a mixed analysis of variance to determine~     significant changes over time for each group. We hypothesize that playgroups will have a~     significant effect on child playfulness, social-emotional growth, participation, and parent~     competence.~   "
38529|NCT03062358|"~     The purpose of this study is to determine the efficacy and safety of pembrolizumab or placebo~     given with best supportive care (BSC) in Asian participants with previously systemically~     treated advanced hepatocellular carcinoma (HCC). The primary hypothesis of this study is that~     overall survival is prolonged in participants who receive pembrolizumab compared to those who~     receive placebo.~   "
38556|NCT03062007|"~     This study will evaluate the safety and tolerability of BI-CON-02 in patients with~     HER2-positive metastatic breast cancer, previously treated with trastuzumab The clinical~     trial protocol for BI-CON-02 prescribes a start dose of 0,3 mg/kg. After the Data and Safety~     Monitoring Committee evaluates the data of tolerability and safety of BI-CON-02, received~     during 3 weeks of investigational product therapy (Week 3, Day 1) and approves, extra doses~     can be used.~      Once the safety of investigational product is confirmed, the dose will be increased in the~     subsequent cohorts. Planned doses - 0,3 mg/kg; 0,6 mg/kg; 1,2 mg/kg; 2,4 mg/kg; 3,6 mg/kg and~     4,8 mg/kg.~   "
38530|NCT03062345|"~     Virtual reality is a video game in which a person and their real-time movements are~     represented on a screen in a virtual environment. This study will compare the use of~     multi-user virtual reality (VR) to single-user VR to determine if either provides superior~     engagement in upper extremity therapy and greater motivation to perform repetitive training.~      Stroke survivors will participate in a longitudinal study in which they will have the~     opportunity to perform rehabilitative training with multi-user VR and single-user VR modes in~     their homes. They will use each mode for 2 weeks, completing 4 session per week, each session~     is 1 hour long. Upper extremity motor control, level of engagement, and active range of~     motion will be assessed at time points during the intervention period.~      Subject evaluations will take place before the intervention, at the midpoint of intervention~     (between switching from multi-user to single-user modes, or vice versa), and at the end of~     the intervention.~      The investigators hope to address two aims:~      Aim 1: To determine if the use in-home multi-user virtual reality treatment results in~     greater engagement in therapy compared with in-home single user virtual reality treatment.~      Aim 2: To determine if in-home virtual reality treatment results in greater practice~      The investigators hypothesize that stroke survivors will be more engaged in therapy when~     training with the multi-user VR system and this will translate into greater practice.~   "
38531|NCT03062332|"~     Background: The gut microbiome is emerging as an important factor in regulating mental health~     yet it remains unclear what the target should be for psychiatric treatment. Investigators aim~     at elucidating the complement of the gut microbiome community for individuals with Major~     Depressive disorder (MDD) and Bipolar disorder (BD) relative to controls, and test for~     relationships with symptoms.~      Methods: Investigators prospect to recruit subjects including patients and controls amount to~     240. All subjects will be collected for blood and stool samples,assessed by clinical scales.~     Finally, analyzing the correlation among the metabolon in blood, microbiota in stool and~     clinical scales to obtain the possible interaction between diseases and gut microbiota.~   "
38532|NCT03062319|"~     The Purpose of this open-label randomized controlled multicenter trial is to evaluate the~     efficacy and safety of mono-drug therapy with oral anticoagulant compared to combination~     therapy with antiplatelet drug, in ischemic stroke patients with non-valvular atrial~     fibrillation and atherothrombosis.~   "
38533|NCT03062306|"~     In recent years, monitorizations during Cardiopulmonary Resuscitation (CPR) are inadequate to~     show the sufficiency of cerebral oxygenation. During CPR, insufficient chest compressions~     have critical importance for neurological results and life quality after the return of~     spontaneous circulation (ROSC).~   "
38534|NCT03062293|"~     The aim of this study is to investigate if six-weeks of exercise intervention, 3 times per~     week on the Functional Re-adaptive Exercise Device (FRED) reduces non-specific mechanical low~     back pain in adults ages 18-60.~   "
38535|NCT03062280|"~     Subjects completing study DIUR-005 and those who have already completed study DIUR-003 will~     be offered the opportunity either to continue Chronocort® therapy or to switch from their~     current glucocorticoid therapy to Chronocort® in this open-label study.~   "
38536|NCT03062267|"~     Testing an mHealth mobile interventionist texting program on illness management.~   "
38537|NCT03062254|"~     Broadly, the objective of this study is to evaluate the fractional decline of intensity of~     tracer uptake measured by SUVmax on 68Ga-PSMA PET/CT in bone metastases from prostate cancer~     following treatment with radium-223 as a surrogate marker for tumor cell killing.~   "
38538|NCT03062241|"~     The aim of the study is to evaluate the impact of cryoablation of atrial fibrillation in~     patients with severe chronic heart failure (CHF) on long term outcome of CHF and efficacy~     (endurance) of the procedure itself. The study hypothesis is that cryoablation in eligible~     patients with CHF and ICD/CRT (implantable cardioverter defibrillator / cardiac~     resynchronization therapy) implants reduce the number of recurrent CHF hospitalizations,~     mortality, need for mechanical support of LV (left ventricle) and heart transplant (primary~     endpoint) at 1 year observation in comparison to traditional (pharmacological) treatment..~   "
38539|NCT03062228|"~     This study was designed and conducted in an effort to establish a comparison group for the~     Ghana PrenaBelt Trial (NTC02379728). The Ghana PrenaBelt Trial examined the effect, on birth~     weight, of a belt-like device to help pregnant women to avoid sleeping on their back during~     sleep in the third trimester. This study will seek to establish the typical birth weight of~     babies born to a cohort of healthy pregnant Ghanian women who are similar in characteristics~     to the women in the Ghana PrenaBelt Trial but who have not been educated to avoid back sleep~     during pregnancy nor have received a device to prevent back sleep.~   "
38540|NCT03062215|"~     The study seeks to evaluate the efficacy of a culturally adapted internet-delivered treatment~     for depression in Colombia. The research involves two studies: (a) the cultural adaptation of~     the Space from Depression cognitive-behavioural internet-delivered programme, and (b) the~     implementation of the culturally adapted intervention using a randomised controlled trial~     methodology. The study will be a first contribution of a culturally adapted low-intensity~     internet-delivered intervention with Latin Americans.~   "
38541|NCT03062202|"~     This study will explore the potential impacts of internet-delivered cognitive behavioural~     therapy (ICBT) at step 3 of the IAPT model. To do this, interventions administered as a~     prequel to face-to-face therapy will be analysed and compared based on their impacts in~     regards to access, outcomes (psychological) and costs. A qualitative segment will also be~     conducted in order to investigate the acceptability and usability of the platform for~     clinicians and the possibility of developing a therapeutic alliance through an online medium.~   "
38542|NCT03062189|"~     The purpose of this study was to assess drinking habits and patterns of alcohol consumption,~     smoking habits, use of illicit drugs and the prevalence of binge drinking and alcohol use~     disorders among Italian young students. Furthermore to investigate the correlation between~     binge drinking and alcohol use disorders.~   "
38543|NCT03062176|"~     Interleukin-1 blockade for the treatment of heart failure in patients with advanced chronic~     kidney disease (End-stage renal disease and Heart fAilure - Anakinra Remodeling Trial) is a~     Phase 2, single-arm trial designed to estimate the effect of anakinra, a recombinant human~     Interleukin-1 (IL-1) receptor antagonist, on cardiorespiratory fitness in patients with~     advanced chronic kidney disease and heart failure.~   "
38544|NCT03062163|"~     To evaluate the lipolysis effect of resveratrol and lipoic acid transdermal patch in~     overweight volunteers~   "
38545|NCT03062150|"~     The steroid hormone cortisol is released in response to stress and acts in the central~     nervous system upon glucocorticoid (GR) and mineralocorticoid receptors (MR). GR are widely~     distributed across the brain while MR are predominantly expressed in the hippocampus and~     prefrontal cortex - two brain areas closely related to memory and executive function.~     Stimulation of MR leads to an increase of glutamate that act on glutamatergic NMDA receptors~     in the hippocampus and prefrontal cortex. In previous studies, the investigators have shown~     that fludrocortisone, a mineralocorticoid receptor (MR) agonist, improves memory and~     executive function in depressed patients and healthy controls. However, depressed patients~     not only exhibit cognitive deficits in traditional neuropsychological domains such as memory~     or executive function. In addition, there are depression-specific alterations such as~     cognitive bias and deficits in social cognition, two clinically highly relevant areas.~     Therefore, the specific aims of this renewal proposal are two-fold:~        -  To examine whether beneficial effects of fludrocortisone in depressed patients can be~          extended to depression-specific cognitive bias and to social cognition~        -  To determine whether beneficial effects of fludrocortisone depend on NMDA-receptor~          function and whether these beneficial effects can be enhanced by NMDA receptor~          stimulation.~      The investigators hypothesize that fludrocortisone will improve cognitive bias and social~     cognition in depressed patients and that its beneficial effects depend on the NMDA receptor.~     Therefore, the investigators further hypothesize that the effects of fludrocortisone can be~     enhanced by co-administration of the partial NMDA receptor agonist D-cycloserine.~      The study not only advances current knowledge by further examining the mechanism of action by~     which MR stimulation exerts beneficial effects on cognition but extends these effects to~     depression-specific cognitive bias and alterations in social cognition. Furthermore, a~     potential interaction between MR and NMDA receptors is highly clinically relevant given the~     promising results with NMDA receptor antagonists in the treatment of major depression.~   "
38546|NCT03062137|"~     An observational comparison of different locations of saturation measurements during Flexible~     Bronchoscopy~   "
38547|NCT03062124|"~     Intraductal papillary mucinous neoplasms (IPMN) have a potential to develop into a malignant~     disease with varying severity. Decision making on when and how to make a therapeutic~     intervention is not simple. Endoscopic equipment that can enter the pancreatic duct itself~     can provide the much needed additional information on the cystic condition. Visual~     inspection, direct visual guided biopsies from the target and the cytology of the flushing~     fluid of the pancreatic duct may be helpful in the decision making process of when and how to~     treat the condition. We study whether SpyGlass pancreatoscopy brings accuracy to the~     diagnostic process concerning IPMNs and does it provide additional information to help make~     decisions about therapeutical interventions. We also document complications related to the~     procedure itself in the following weeks after the procedure.~   "
38548|NCT03062111|"~     Benign prostatic hyperplasia (BPH) refers to the proliferation of smooth muscle and~     epithelial cells of the prostate gland. The enlarged gland has the potential to result in~     lower urinary tract symptoms (LUTS) secondary to either bladder outlet obstruction or~     increased muscle tone and resistance, or both.~      For decades transurethral resection of the prostate (TURP) has been the gold standard for~     treatment of symptomatic BPH that is refractory to nonoperative management. This is a~     surgical intervention aimed to reduce the size of the prostate gland. However, over the past~     fifteen years, many alternative therapies have been introduced including laser enucleation of~     the prostate (LEP). LEP has numerous advantages including decreased blood loss and length of~     hospital stay as well as increased effectiveness and safety for large prostate gland sizes~     (>80g).~   "
38549|NCT03062098|"~     This trial seeks to improve ultrasound imaging during embryo transfer in IVF by using a~     small, high resolution ultrasound probe used routinely for cardiac imaging in children.~   "
38550|NCT03062085|"~     The purpose of this study is to evaluate the long-term visual outcome of the cataract surgery~     using a large-scale and comprehensive database of high myopic cataract and age-related~     cataract patients. The investigators will further investigate into the various genetic and~     environmental factors that may contribute to the pathogenesis of high myopic cataract.~   "
38551|NCT03062072|"~     To assess chemotherapy related hyperglycemia in non-diabetic patients, the investigators will~     assess the incidence of hyperglycemia and analyze co-medications and risk factors.~   "
38552|NCT03062059|"~     The aim of this study is to evaluate the effectiveness and safety of intravesical gemcitabine~     instillation during operation to prevent intravesical recurrence after radical~     nephroureterectomy in upper urinary tract urothelial carcinoma.~   "
38553|NCT03062046|"~     The purpose of this study is to assess the safety, acute and long term effectiveness, during~     standard RF ablation procedures while using Ablation Index and VISITAG™ software in~     combination with a Thermocool SmartTouch® (ST) or SmartTouch Surroundflow® (STSF) catheter.~     Furthermore, the role of Ablation Index and VISITAG™ workflow in creating contiguous ablation~     lines is assessed. The study is a prospective, non-randomized, post-market clinical~     evaluation. Up to 330 patients will be included in this study. All patients who qualify based~     on the study specific requirements will be invited to participate. The total duration of the~     study is estimated to be about 24 months (12 months enrollment period and 12 months of follow~     up). The clinical investigation population include subjects undergoing RF ablation for~     treatment of drug resistant symptomatic paroxysmal AF. Prior to enrollment in the clinical~     investigation, all subjects must meet the inclusion/exclusion criteria and are suitable~     candidates for enrollment in a clinical investigation in the opinion of the investigator.~     Subjects must have failed at least one antiarrhythmic drug (AAD) (Type I or III, including~     β-blocker) as evidenced by recurrent or are intolerant of the AAD.~   "
38554|NCT03062033|"~     Prospective study to quantify the prevalence of possible tardive dyskinesia (TD) in~     outpatient psychiatry practices in the United States (US), as well as to describe the~     associated disease burden in a cohort of patients with one or more psychiatric disorders and~     a cumulative lifetime exposure to antipsychotic medication of three months or more.~   "
38555|NCT03062020|"~     The QUIPP tool integrates information of obstetrical history, quantitative fetal fibronectin~     (qfFN) and cervical length to predict the risk of sPTB in asymptomatic high-risk women.~      The aim of this study is to evaluate the QUIPP tool in our setting in order to optimize the~     management of women at high risk for sPTB and to validate in a randomized clinical trial,~     whether the use of QUIPP improves efficiently the management of our asymptomatic high-risk~     women when it is compared with the current clinical management.~      Design: Randomized controlled trial. Inclusion criteria: Asymptomatic singleton pregnancies~     18,0-22,6 weeks at high-risk for sPTB. Sample size: According to a non-inferiority analysis,~     129 pregnant women will be needed for each arm.~      Methodology: Patient selection and who consent to participate in the study will be randomized~     into two arms: a) Intervention group: QUIPP tool will be used to select and manage patients~     attending our PBPC: high-risk patients will be followed-up in our PBPC and low-risk patients~     will be discharged from PBPC and managed in a low-risk unit. b) Control group: Women will be~     managed according to current clinical practice.~      Main Outcome: sPTB <34,0 and <37,0 weeks of gestation. Secondary Outcomes: Pregnancy outcomes~     and a neonatal composite morbidity. Expected Results: Perinatal outcomes are similar in the~     intervention and control group although the intervention group using the QUIPP tool required~     less medical resources.~   "
38562|NCT03061929|"~     Nutritional profile of mother's milk is influenced by various factors including~     environmental, dietary and nutritional status of the mother. Given the huge diversity noted~     in nutritional status and ethnic dietary patterns in Indian population, including pregnant~     and lactating mothers, it can be conceivably predicted to have an influence on milk~     composition. With the lack of recent literature addressing these, it is vital to understand~     and update the influence if any, of nutritional status and dietary patterns on nutritional~     quality of human milk. The proposed Human milk analysis clinical study in Indian mothers is~     aimed to achieve a more recent and updated database of nutritional profile of Indian mother's~     milk considering the dietary and regional influences and demographic differences which can~     play a key role in levels of nutrients in mother's milk. In order to incorporate the varied~     dietary patterns, milk samples will be collected from mothers recruited from 8 sites across~     the country and analysed for important nutrient levels.~   "
38563|NCT03061916|"~     Chlorhexidine is the most potent chemotherapeutic agent against mutans streptococci and~     dental caries, however, the incidence of side effects such as teeth discoloration, staining~     of restorations, undesirable taste, discoloration of tongue, dryness and burning sensation in~     the mouth discourage patients to use this mouth wash. Natural products are now preferred by a~     large proportion of the population and have been reported to possess antimicrobial~     activity.These products have recently been shown to be a good alternative to synthetic~     chemical substances for caries prevention like Cinnamon and Ginger. The aim of this study is~     to compare the antimicrobial effects of aqueous extracts of cinnamon 20% and ginger 20% in~     comparison to chlorhexidine gluconate 0.2% on oral streptococcus mutans~   "
38564|NCT03061903|"~     High risk patients who receive direct anterior approach total hip arthroplasty are more~     likely to experience wound complications. The purpose of this study is to determine whether~     the usage of closed incision negative pressure dressings decreases the risk of wound~     complication compared to standard dressings. Patients who decide to participate in the study~     will be randomized to one of the two dressing prior to surgery and will leave the operating~     room with one of the treating dressings. Patient will be monitored 90 days after surgery for~     wound complications and pictures of the wounds will be taken. The patients course of~     treatment besides being randomized to one of the two dressings will be identical to any other~     patient received a Direct Anterior Approach for Total Hip Arthroplasty (DAA THA).~      The primary outcome measure will be uneventful wound healing (requiring no intervention)~     versus the occurrence of wound complications (wound drainage, breakdown, necrosis,~     dehiscence, superficial or deep infection) requiring additional intervention. Intervention~     will be defined as any attempt of the surgeon to improve wound healing (in-office~     debridement, topical ointment, aspiration, antibiotic therapy, or return to the OR for the~     wound). Secondary outcome measures will include duration of wound healing delay, length of~     hospital stay, number of days of antibiotic therapy, and direct and estimated indirect costs.~   "
38565|NCT03061890|"~     The DINE study will test the hypothesis that potentially avoidable NICU-based exposures~     contribute to the neuro-cognitive and somatic impairments prevalent among NICU graduates.~     This hypothesis is drawn from the documented impact of phthalate exposure on early~     development in term-born children, and the acknowledged presence of these toxic chemicals in~     the NICU. Third trimester in utero exposure to phthalates have been linked to poorer~     childhood performance in cognition, motor function, attention, hyperactivity and social~     behavior. Phthalate exposure is also associated with altered onset of puberty and asthma. The~     multi-site cohort and approach will clarify the role of NICU-based phthalate exposure on~     high-prevalence clinical outcomes.~   "
38566|NCT03061877|"~     Anxiety and depression are highly prevalent in people with rheumatoid arthritis (RA).This~     study is to investigate the effect of anxiety and depression on treatment response in people~     with RA using observational longitudinal study design.~   "
38567|NCT03061864|"~     Pregnant women who are at risk of delivering their infants in the periviable period can~     suffer a large amount of stress and anxiety. Moreover, many women feel a loss of control over~     their own pregnancy. There is some evidence that more counseling and planning can help reduce~     maternal stress and anxiety. Patients at risk of delivering in the periviable period will be~     randomized to either receive standard counselling or to complete the periviable birth plan.~   "
38568|NCT03061851|"~     The patients with type 2 diabetes who underwent routine hypoglycemic agents and insulin~     therapy were evaluated for 48 weeks with maltose software.~   "
38569|NCT03061838|"~     This is a multicenter, double-blind, randomized clinical study of safety, tolerability,~     pharmacokinetics and pharmacodynamics of biosimilar drug Ritumax® compared to original drug~     MabThera® in patients with rheumatoid arthritis, receiving stable doses of Methotrexate.~      At Week -2, after signing the Patient Information Sheet and Informed Consent Form, patients~     with rheumatoid arthritis receiving stable doses of Methotrexate (10-25 mg per week orally or~     parenterally) will pass screening procedures.~      Patients meeting all the inclusion/exclusion criteria will be invited to the investigational~     site for Visit 2 (Week 0) to be randomized into one of two treatment arms:~        -  Ritumax® 1000 mg х 2 intravenous infusions~        -  MabThera® 1000 mg х 2 intravenous infusions After being assigned to the treatment arm~          patients will receive a course of study treatment, including two i/v infusions at 14-day~          interval: at Week 0 and Week 2.~      After that, patients will be followed up for the next 22 weeks. Safety, pharmacokinetic and~     pharmacodynamic parameters will be monitored at this visits.~   "
38570|NCT03061825|"~     The purpose of this study is to evaluate the clinical performance of the Zenith Alpha™~     Abdominal Endovascular Graft for the treatment of abdominal aortic or aorto-iliac aneurysm.~   "
38571|NCT03061812|"~     The purpose of this randomized, open-label, 2-arm, Phase 3 study is to assess the assess the~     efficacy, safety and tolerability of rovalpituzumab tesirine versus topotecan in participants~     with advanced or metastatic Small Cell Lung Cancer (SCLC) with high levels of delta-like~     protein 3 (DLL3) and who have first disease progression during or following front-line~     platinum-based chemotherapy.~   "
38586|NCT03061617|"~     It is controversial as to which ventilation mode is better in one-lung ventilation(OLV),~     volume controlled ventilation(VCV) or pressure controlled ventilation(PCV). This study was~     designed to figure out if there was any difference between these two modes on oxygenation and~     postoperative complications under the condition of protective ventilation(PV).~   "
38572|NCT03061799|"~     In women, as the age increases, ovarian function is lost, resulting in the deficiency of~     female hormones, resulting in menopause, in which menstruation is permanently lost. The~     average age of menopause in Korean women is 49.7 years old, which is equivalent to 22.3% of~     the total female population. In addition, the increase in the number of women who experience~     early menopause due to environmental factors such as stress as a result of the increase in~     the number of women entering the society is also a major cause of the expansion of the market~     for menopausal women's health functional foods. Women's menopausal symptoms have been~     regarded as a natural process for everyone, but with the recent interest in health and the~     results of related studies, the perception that menopausal symptom management is necessary~     has spread.~      In traditional medicine of far east asia, danggui (Angelica gigas Nakai), taeunggung (Cnidium~     Rhizome), and broilers (Cinnamon bark) have been commonly used for postmenopausal symptoms~     improvement. However, scientific evidence for these foods are lacking. Therefore, in this~     study the investigators tried to examine the efficacy and safety of extracts of angelica~     gigas nakai, cnidium rhizome, and cinnamon bark in postmenopausal symptoms. This study is~     designed as double-blinded placebo control study.~   "
38573|NCT03061786|"~     Acute kidney injury (AKI) is a common clinical syndrome, especially in the hospital patients.~     AKI is recognized as an important risk factor for incident chronic kidney disease,~     accelerated progression to end-stage renal disease,and increased risk of short-term and~     long-term mortality.This study is to observe the prognosis of hospitalized patients with AKI~     in China.~   "
38574|NCT03061773|"~     The treatment of breast cancer at any given time can be through surgery, as well as adjuvant~     treatments (radiotherapy, chemotherapy and hormone therapy) alone or together. And with this~     the patient tends to lose weight, he becomes depressed, resulting in an increasingly~     debilitating picture. Therefore, the present study aims to investigate the relationship~     between physical exercise and its effects on quality of life in patients with breast cancer,~     those who underwent surgery for at least 6 months, patients who are still with the Tumor~     using the adjuvant treatments submitted to physical exercises and not submitted. The sample~     will consist of 25 to 50 female patients aged 18 to 75 years. Patients will be submitted to~     the initial quality of life evaluation (SF - 36 reduced version, Anxiety and depression (HAD~     Scale), Fatigue (Piper Fatigue Scale), Pain (Brief Inventory of Pain), Body Composition~     (Bioimpedance BYODINAMICS 450 ) And oxidative stress markers (oxidized and reduced~     glutathione, TBARS / MDA, Myeloperoxidase and Creatinine), inflammatory markers (IL1, IL6,~     IL8, IL10, MCP-1 and TNF-α), hormones Estrogen, progesterone), blood test (complete blood~     count) 24 hour food recall (24hs food recall), and perform the maximum repetition test to~     find the initial workload that will be adjusted every 4 weeks with the evaluation of the load~     and Completing the 12 weeks of training will be reevaluated following the initial evaluation.~     The data collected will be treated statistically with an α=5% using the software Stata 12.0.~   "
38575|NCT03061760|"~     This study is designed to evaluate men before radical prostatectomy for the incidence of~     Overactive Bladder (OAB), as well as urge urine incontinence (UUI) development after the~     surgery. Patients will be evaluated for signs of OAB and for signs of Bladder Outlet~     Obstruction (BOO). Afterwards they will be divided into four observational groups. Follow up~     period is designed to be 12 months.~   "
38576|NCT03061747|"~     Multicentric, observational, retrospective registry including patients underwent implantable~     device implantation (pacemaker or ICD) for any indication in the period from 2009 to 2016,~     followed by remote monitoring. The aims of the registry are to evaluate the occurrence of~     atrial arrhythmias, of hospitalizations, and the mortality during a long-term follow-up.~   "
38577|NCT03061734|"~     This proof -of-concept study compares ALLOD-2 to its individual components and to placebo.~      The investigational product (ALLOD-2), is a combination of two marketed drugs. Both drugs are~     used at a much lower doses than the doses used for the approved indications.~      The combination is a First-in-Class drug due to its new and unique mechanism of action.~   "
38578|NCT03061721|"~     This is a randomized, double-blind, placebo-controlled study in up to 104 patients with a~     diagnosis of NAFLD and/or NASH. The study will be conducted over a period of up to 22 weeks~     and will include an optional Prescreening, Screening (Days -35 to -7) Phase, a 16-week~     Treatment Phase following randomization on Day 1. Patients will be randomly assigned in a~     ratio of 1:1:1:1 to receive Saroglitazar Magnesium 1mg or 2 mg or 4 mg or matching placebo~     once daily in the morning before breakfast for 16 Weeks. The primary endpoint of the study is~     percentage change from baseline in serum ALT levels at Week 16 in the Saroglitazar Magnesium~     groups as compared to the placebo group.~   "
38579|NCT03061708|"~     Phase II trial of AZD2014 in RICTOR amplified or overexpressed GC patients as second-line~     chemotherapy AZD2014 50mg BD continuous schedule of a 28 day cycle~   "
38580|NCT03061695|"~     This observation study is to evaluate the application of the spectral analysis and~     characteristic parameters of digitized respiratory sounds in the confirmation of the position~     of the balloon of endobronchial blockers~   "
38581|NCT03061682|"~     Age related macular degeneration (AMD) is the leading cause of vision loss in patients older~     than 55 years old. AMD can present as dry AMD or wet AMD. In most cases AMD affects both eyes~     although in many cases it's asymmetrical as far as severity. Some patients require low vision~     aids to continue their daily life tasks. In the past a few attempts were made to use low~     vision intraocular lenses with corrective glasses without enough success. In addition~     telescopic and prismatic lenses were also tried. The difficulties with these lenses included~     low field of vision, unsatisfactory magnification, complicated surgical technique and high~     complication rates.~      Recently an add on lens was designed for the sulcus for implantation in pseudophakic AMD~     patients. The add on lens doubles the magnification of the central image dependent on the~     reading distance and the anatomy of the eye.~      The lens is acrylic hydrophobic and designed for implantation in the sulcus either in~     pseudophakic patients or in addition to an intraocular lens implanted during a routine~     cataract surgery. The lens is 13 mm wide with 4 symmetric haptics. The lens has 1.5 mm~     central part of 10 diopters and the rest of the lens has no optical power.~      Our purpose is to study implantation of the lenses in AMD patients to improve their reading~     ability and to improve their daily living.~   "
38582|NCT03061669|"~     Respiratory monitoring during right heart catheterization to differentiate between various~     types of pulmonary hypertension; The effects of the cardiovascular system on the lung~     mechanical properties.~   "
38587|NCT03061604|"~     INTRODUCTION Acute variceal bleeding (AVB) is a severe complication of portal hypertension in~     patients with liver cirrhosis. The primary therapy includes the administration of vasoactive~     drugs, antibiotics and endoscopic therapy; preferably esophageal banding ligation (EBL)~     and/or cyanoacrylate injection when bleeding occurs from gastric varices.~      In this context, the idea is to assess Hemospray (Cook Medical, Winston-Salem, NC) as an~     initial therapy in patients with massive bleeding as a temporary bridge until definitive~     treatment could be instituted.~      The data generated from the pilot study performed between Erasme hospital, ULB and TBRI ,~     Cairo showed that adding Hemospray as early as possible in the management steps could~     increase the bleeding control rate up to 95 % at 24 hours.~      OBJECTIVE The primary efficacy objective of this study is to assess the efficacy of Hemospray~     in combination with standard of care (SOC) medical treatment compared to the efficacy of SOC~     in the Control Arm in patient with acute variceal bleeding in cirrhotic patient.~      The primary safety objective of this study is to evaluate the safety of Hemospray when used~     in combination with SOC compared to SOC in the Control Arm.~      1.1. Secondary:~        -  To evaluate the effect of timing of Hemospray treatment on the outcomes of bleeding~          patients~        -  To evaluate the adverse effects on both therapeutic regimens (SAEs and clinically~          significant AEs).~   "
38588|NCT03061591|"~     A Phase 2, randomized, double blind, placebo controlled trial for the effectivness of~     wholistic turmeric supplementation on polyp burden mong patients with Familial Adenomatouse~     Polyposis (FAP). Fourty Patients will be randomly assigned in a 1:1 ratio to recieve~     treatment with 8 capsuls (2*4 capsuls/day) of wholistic Turmeric capsules (Pukka herbs) or~     placebo for six months.~   "
38589|NCT03061578|"~     The study consists of 3 study visits to the clinic over at least 9 days. Visit 1 - the~     medical screening visit: subjects will undergo informed consent and will be tested for signs~     and symptoms of Dry Eye Syndrome (DES) including measurements by the TFI.~      Upon conclusion of the screening for DES, the subjects will be divided to the different~     categories: NDE, LDDE and ADDE. For ADDE and LDDE subjects the eye fitting the worst DES~     inclusion criteria will be designated as the study eye. For the NDE subjects the best eye~     will be designated as the study eye.~      During Visit 2 and 3, the TFI measurement and other clinical study endpoint procedures will~     be only conducted on the study eye. The safety endpoint procedures will still be conducted on~     both eyes individually throughout the study. Subjects will be queried for adverse events~     (AEs) at all visits.~      Visit 2 - after two days washout period subject will return for the LH-EEC test. Signs and~     symptoms of dry eye will be recorded before entering the LH-EEC, during the 120 min stay in~     the LH-EEC and at the conclusion of the day.~      Visit 3 - after 7 days washout period subject will return for the last test. The third day~     procedure is identical to the second day, with the addition of: following LH-EEC exit,~     subjects will have a health check and study check out procedures conducted.~      Statistical Analysis:~      Data will be summarized with respect to baseline characteristics, efficacy variables and~     safety variables. Summary statistics will include the number of observations (N), mean,~     standard deviation (SD), median, minimum and maximum values for continuous variables and~     frequencies and percentages for categorical variables.~      Missing values will not be replaced or imputed, i.e., no interpolation or extrapolation will~     be applied to missing values.~      Safety data will be listed and summarized by group (NDE, ADDE, and LDDE).~   "
38590|NCT03061565|"~     Traumatic brain injury is catastrophic event that commonly require treatment in an intensive~     care unit. Management is mainly supportive aiming at avoiding hypoxia, hypotension,~     hypoglycaemia and increased intracerebral pressure. Thus far efforts to find a specific~     pharmacologic therapies have been disappointing. Recently it was demonstrated that~     recombinant erythropoietin has been found to decrease mortality at six months from injury but~     without significantly improving functional neurological outcome (GOSe). Whether this survival~     benefit of EPO is sustained beyond 6 months is unknown.~      In the current study survival data will be collected centrally and patients alive or person~     responsible will be invited to participate in an evaluation of neurological function and~     quality of life. Factors associated with time to death as well as factors associated with~     long term quality of life will be determined with statistical methods.~   "
38591|NCT03061552|"~     Determination of dry weight in patients with end-stage renal disease treated with~     hemodialysis is an unmet challenge in clinical nephrology. Current methods are imprecise, and~     thus many patients are hype- or hypovolemic, and suffer respective consequences such as~     hypertension, pulmonary congestion, cardiac hypertrophy, chronic dehydration, hypotension and~     shock.~      Several techniques have been proposed to asses hydration status in dialysis patient, among~     them measurement of bioimpedance and biochemical markers. Sonographic measurement of the~     inferior vena cava diameter (IVCD) is a method under investigation for assessing hydration~     status. It is available, inexpensive and efficient, yet operator-dependent. In a~     single-center, blinded and controlled trial it has been shown to improve clinical outcomes in~     patients receiving hemodialysis.~      In this study, we aim to assess the applicability and clinical utility of this method in our~     dialysis units. A crossover design is intended to examine the effect of IVCD measurement on~     quality of life and rate of hemodynamic adversities as compared with traditional estimation~     of dry weight.~   "
38592|NCT03061539|"~     The primary objective is to test the following hypothesis: Patients with metastatic castrate~     resistant prostate cancer that have progressed following at least one line of therapy and~     have an immunogenic signature will respond to combined PD-1 and CTLA4 inhibition.~   "
38593|NCT03061526|"~     Retinal vessel occlusions might lead to ischemia of the inner retina, more severe so in~     artery occlusions. Intracellular edema may develop and decrease transparency of those layers,~     showing retinal edema. In spectral domain optical coherence tomography (SD-OCT) retinal~     reflectivity changes as a result of retinal edema. The investigators examine the reflectivity~     changes of different retinal layers between healthy eyes and eyes with retinal artery~     occlusion and ischemic or non-ischemic vein occlusions. Aim of the study is to evaluate~     whether those changes can be used to measure the level of ischemia in the inner retina.~   "
38594|NCT03061513|"~     The purpose of this study is to find out whether ubiquinol is well tolerated, can affect the~     symptoms of Parkinson's Disease and change the energy levels in the brain. Subjects will be~     randomized to taking ubiquinol or placebo and will have a neurological evaluation, magnetic~     resonance spectroscopy (MRS) and blood test for biological markers taken during the study.~   "
38595|NCT03061500|"~     An observational, prospective study whose main objective is to measure the value of~     Pro-adrenomedullin as a prognostic marker and predictor of mortality in patients with~     intra-abdominal sepsis after damage control surgery.~   "
38650|NCT03060785|"~     This is an open-label, steady-state study of Tenofovir (TFV) and Emtricitabine (FTC)~     pharmacokinetics (PK) in transgender women taking feminizing hormones. Half of the~     participants will be transgender women on feminizing hormones, the other half will be male~     volunteers not taking any hormone therapy.~   "
38596|NCT03061487|"~     The altered balance between the proteinases and their tissue inhibitors (TIMPS) is one of the~     pathogenetical mechanism of the aneurysmatic connective tissue degeneration. The increasement~     of protease, collagenase and elastase activity results indeed in a dramatic drop of collagen~     and elastin tissue and serum levels.Matrix Metalloproteinases (MMPs) are a group of~     proteolytic enzymes that along with their specific and non-specific inhibitors modulate the~     extracellular matrix composition. Recent studies have suggested an interesting role of~     microRNAs (miRNAs) in the regulation mechanisms of inflammation.~      The aim of our study is to analyse the influence of statin treatment on aneurysmatic disease~     by monitoring MMPs and miRNAs in aneurysmatic wall tissue and MMps blood levels.~   "
38597|NCT03061474|"~     The purpose of this research study is to test whether nicotinamide, also known as vitamin B3~     or niacinamide, taken in high doses, can reduce phosphorylation of tau (the protein that~     accumulates in neurofibrillary tangles) in people with Mild Cognitive Impairment or mild~     Alzheimer's disease (AD) dementia.~   "
38598|NCT03061461|"~     This study tests the hypothesis that radial extracorporeal shock wave therapy (rESWT) as~     performed by Zoech (JATROS Orthop 2009;(1):46-47) is effective and safe in treatment of~     chronic soft tissue wounds, and is statistically significantly more effective than~     sham-treatment of chronic soft tissue wounds.~   "
38599|NCT03061448|"~     The purpose of this study is examine if an internet-based exposure therapy based on~     inhibitory learning is feasible, acceptable and effective in reducing panic symptoms amongst~     patients who suffer from panic disorder and agoraphobia.~   "
38600|NCT03061435|"~     Almost half of all women will develop an HPV infection in their lifetime. While most~     infections are naturally asymptomatic or cleared by the immune system, some persist and can~     lead to the development of cervical, vulvar, or anal lesions and eventually cancer. Screening~     regimens for these lesions are currently only in place for the cervix through regular Pap~     tests. These Pap tests usually involve an examination of the vulva -however, no screening~     procedures exist for anal cancer for women. Several studies have suggested that women with~     existing gynecological lesions are more likely to develop anal lesions and anal cancer. Here~     the investigators propose a multi-center study which seeks to screen for and treat anal~     cancer in women over the age of 40 with vulvar lesions and a stable immune system. The~     investigators will achieve this through performing anal Pap smears on eligible women and~     conducting High Resolution Anoscopy (HRA) and appropriate treatment procedures on those with~     abnormal anal cells. With enough evidence, there may be an indication to establish regular~     anal cancer screening measures in this potentially underserved population.~      Hypothesis: The investigators hypothesize that at least 40% of women with vulvar cancer or~     VIN2/3 will have abnormal anal cytology. 35% of the population will be hrHPV DNA positive and~     11% will additionally have AIN2/3. This prospective study may lay the groundwork for routine~     anal screening regimens in Ontario and help shift health policy to treat this population.~   "
38601|NCT03061422|"~     36 eligible participants will be randomly divided into three groups (n=12) according to the~     tested chewing gum (A), where (A1) represents participants exposed to xylitol chewing gum,~     (A2) represents participants exposed to bicarbonate and xylitol chewing gum and (A3)~     represents control group where participants are exposed to paraffin pellet chewing. The pH of~     saliva will be evaluated according to time in relation to the gum chewing (T) where (T0)~     represent the pH before chewing, (T1) represent 5 minutes after gum chewing at fixed time of~     the day (in the morning from 10 to 11 am).~      Direct benefit of the research to the human volunteer:~      It is important for high caries risk patients to decrease caries susceptibility as this will~     eventually decrease their dental treatments and subsequently the treatment cost.~      Scientific value and social benefits:~      This study will benefit the dentist as the main goal of a dentist is to prevent rather than~     cure. Also, it will decrease the restorative work carried out by dentist and save this time~     for educating more patients about caries prevention methods.~      Expected risk to the human subjects:~      Allergic reactions due to any of the components of the materials used which is rare to occur.~   "
38602|NCT03061409|"~     Nutrient intake through diet and nutritional supplements are critical determinants of plasma~     nutrient status. In addition, untoward drug-nutrient can contribute to nutritional~     inadequacy. Among medications used by the elderly in the US, diuretics, metformin, and proton~     pump inhibitors (PPIs) are ranked among the most commonly prescribed. Use of these~     medications is variously associated with inadequate status of many micronutrients, e.g.,~     vitamins B1, B9 (folate), B12, C, and thiamine and the minerals calcium, iron, potassium,~     magnesium, and zinc. While diets rich in whole grains, fruits, and vegetables can help~     decrease the risk for micronutrient inadequacy in older adults using one or more of these~     drugs, supplementation may prove more effective to restoring and/or enhancing their nutrient~     status. When compared to a placebo, investigators hypothesize that a~     multivitamin-multi-mineral (MVM) supplement will improve nutritional status in older adults~     at increased risk of micronutrient inadequacy induced by drugs commonly used by this~     population, specifically diuretics, metformin, and PPIs. Investigators also hypothesize that~     MVM supplementation will beneficially modify selected biomarkers or biochemical pathways of~     cellular function/health. To test these hypotheses, investigators will conduct a randomized~     clinical trial by pursuing the following specific aims: 1) To determine the extent by which~     MVM supplementation (compared to placebo) will increase the plasma status of vitamins B12, C,~     D, folic acid, and thiamine and the minerals iron, magnesium, potassium, and zinc; 2) To~     quantify indices of 'metabolic health' including one or more of the following biomarkers:~     glutathione/oxidized glutathione (GSH/GSSG ratio), ubiquinol/ubiquinone, malondialdehyde~     (MDA), asymmetric dimethyl arginine (ADMA), selected cytokines and chemokines, homocysteine,~     methylmalonic acid (MMA).~   "
38603|NCT03061396|"~     The purpose of this study is to clarify whether the matching acupoints are more effective~     than a single point by electro-acupuncture in the management of chemotherapy-induced nausea~     and vomiting.~   "
38604|NCT03061383|"~     This is a randomized, triple-blind, placebo-controlled study. 51 subjects with a confirmed~     diagnosis of dentin hypersensitivity were randomized to one of three treatments: Arginine~     based toothpaste, strontium acetate based toothpaste , or placebo. Treatment will be done at~     baseline then patients will use the toothpaste at home twice per day by using soft bristled~     tooth brush and the given dentifrice using modified stillmans method as explained by~     examiner. Standard test stimuli is calibrated short blast of air syringe, will be applied to~     sensitive dentin surfaces. Subjects recorded the intensity of sensitivity in response to~     stimulus on a visual analog scale at baseline, and after 1 week, 2 weeks and 3 months.~   "
38726|NCT03059784|"~     High rates of recurrent cardiovascular events and readmission after percutaneous coronary~     intervention (PCI) are important issues. Guidelines emphasize rehabilitation and secondary~     prevention. But many patients are lack of effective management after PCI.This study is aimed~     to examine the effect of mobile application (APP)-based multifaceted management on the~     improvement of long-term care after PCI.~   "
38605|NCT03061370|"~     In line with improvements in oncologic outcome for patients with esophageal cancer, the~     attritional impact of curative treatment with respect to functional status and health-related~     quality of life (HR-QL) in survivorship is increasingly an important focus. Functional~     recovery after surgery for esophageal cancer is commonly confounded by anorexia and early~     satiety, which may reduce oral nutrient intake with consequent malnutrition and weight loss.~     One in three disease-free patients has more than fifteen percent body weight loss at three~     years after esophagectomy.~      The ESPEN Special Interest Group on cachexia-anorexia in chronic wasting diseases has defined~     sarcopenia as skeletal muscle index (SMI) of ≤39 cm2/m2 for women and ≤55cm2/m2 for men,~     while similar cut-off points have been validated in upper gastrointestinal and respiratory~     malignancies (less than 38.5 cm2/m2 for women and 52.4 cm2/m2 for men). The European Working~     Group on Sarcopenia in Older People (EWGSOP) additionally recommends that assessment should~     also include determination of muscle function, for example gait speed or grip strength, where~     possible.~      The presence of sarcopenia is associated with increase treatment-associated morbidity,~     impaired HR-QL, reduced physical and role functioning, and increased pain scores in older~     adults. In addition, a previous longitudinal study demonstrated that the decline in HR-QL~     over a six year period in older adults was accelerated in the presence of sarcopenia. As~     such, sarcopenia may represent a modifiable barrier to recovery and subsequent retention of~     HR-QL and functional status, and may reinforce a persistent illness identity, among patients~     following potentially curative treatment for esophageal cancer.~   "
38606|NCT03061357|"~     This project was to examine the effects of incorporating modern wearable technology into the~     credit-based Physical Activity Instructional Program for promoting habitual levels of~     physical activity among college students.~   "
38607|NCT03061344|"~     Study Objectives The current definitive treatment options for urethral stricture disease~     include endoscopic urethrotomy known as Direct Vision Internal Urethrotomy (DVIU) or open~     reconstruction known as urethroplasty (1-6). The purpose of this study is to determine~     feasibility of endoscopic-only repair of urethral stricture or bladder neck contracture using~     a combination of existing surgical techniques of internal urethrotomy (or bladder neck~     incision) augmented by buccal mucosal graft.~   "
38608|NCT03061331|"~     This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, crossover study~     that will evaluate the efficacy of LUM/IVA in subjects with CF 12 years of age and older who~     have at least one A455E mutation.~   "
38609|NCT03061318|"~     A clinical trial is proposed, to clinically validate the diagnostic performance of a new~     genetic test developed in Chile. It will determine the nature of thyroid nodules that have~     been informed as indeterminate by cytology through a fine needle aspiration (FNA).~      The Genetic Classifier for Indeterminate Thyroid Nodules is a quantitative gene expression~     test, that combines the results for a panel of 10 biomarkers (CXCR3, CCR3, CXCl10, CK19,~     TIMP1, CLDN1, CAR, XB130, HO-1 and CCR7), to generate a single number score. It is indicated~     on patients with a thyroid nodule informed by cytology as indeterminate (Bethesda III and IV,~     according to The Bethesda System for Reporting Thyroid Cytopathology). This test would be~     used by taking a sample with a fine needle aspiration (FNA) and thus, being able to predict,~     with high accuracy, benign nodules that do not require surgery.~   "
38610|NCT03061305|"~     Many patients are treated for advanced cancer without knowledge of underlying molecular~     features that might indicate FDA approved therapies or potential eligibility for~     biomarker-selected clinical trials. Strata Oncology is initiating the Strata Trial~     (STR-001-001) with the primary goal of understanding the proportion of subjects available for~     clinical trials and approved targeted therapies in advanced cancer while assessing the~     feasibility of using a large-scale NGS screening program to match subjects for eligibility~     assessments in clinical trials and/or for approved targeted therapies. The Strata Trial does~     not require additional procedures but rather uses surplus, or leftover tumor specimens for~     molecular profiling.~   "
38611|NCT03061292|"~     Implantation of cardiac implantable electronic devices are generally carried out using~     intermittent intravenous conscious sedation combined with local anaesthesia. The main~     advantage of this technique is in avoiding the potential risks of general anaesthesia.~     However, the use of this Sedation - Local Anaesthesia technique is not without complications.~     Peri -procedural hypoxaemia and hypotension are well recognised complications of this~     technique.~      The pectoral nerves (Pecs) blocks are novel techniques to block the pectoral,~     intercostobrachial, third to sixth intercostals, and the long thoracic nerves. PECS block~     targets the lateral and median pectoral nerves at an interfascial plane between the~     pectoralis major and minor muscles.~      A case report by Fujiwara et al has described the use of this technique to provide good~     analgesia during and after these implantation procedures surgery. Pectoral nerves block along~     with minimal sedation has been used as a safe technique in our local set up as well.~      Hence, we propose a randomized, single center, controlled trial on patients undergoing~     cardiac implantable electronic device implantation with local anaesthesia and sedation with~     and without Pectoral Nerve Block.~   "
38612|NCT03061279|"~     The purpose of this study is assess the safety and efficacy of Acutrak headless screws in~     comparison to other fixation methods (traditional headed screws, plates, and wires) used in~     the treatment of medial malleolus fracture of the ankle joint.~      The investigators hope to learn the following objectives from this study~        1. Prospectively establish equivalence with respect to fracture union rate after Acutrak~          headless compression screw fixation when compared to other fixation methods for medial~          malleolus fractures.~        2. Prospectively establish equivalence with respect Patient Reported Outcome Measurement~          Information System (PROMIS) scores after Acutrak headless compression screw fixation~          when compared to other fixation methods for medial malleolus fractures.~        3. Prospectively establish superiority with respect to hardware related pain after Acutrak~          headless compression screw fixation when compared to other fixation methods for medial~          malleolus fractures.~        4. Prospectively establish superiority with respect to the hardware removal rate after~          Acutrak headless compression screw fixation when compared to other fixation methods for~          medial malleolus fractures.~      Patients scheduled for open reduction and internal fixation for medial malleolus fracture by~     using Acutrak headless screw or any other method will be asked to enroll by the attending~     physician, and those patients will be asked to consent to the study. Patients will be~     randomized by sealed envelope to surgical fixation with traditional headed screws, plates,~     and wires or Acutrak headless compression screws. At the time of randomization, the fracture~     pattern and severity, past medical history and medications, and demographic data will be~     documented. After operative fixation, patients will receive routine fracture follow-up with a~     clinical evaluation for tenderness, radiographs to evaluate stability and union, and complete~     the PROMIS and Visual Analogue Pain Scale (VAS) scores to 2 weeks, 6 weeks, 3 months, 6~     months, 1 year, and 2 years after surgical fixation~   "
38727|NCT03059771|"~     Motivation deficits are a strong determinant of poor functional outcomes in people with~     schizophrenia. Mobile interventions are a promising approach to improving these deficits, as~     they can provide frequent cues and reinforcements that support goal-directed behavior. The~     primary aims of this study are to conduct a pilot study using a randomized design to 1) Test~     the feasibility and acceptability of a personalized mobile text message intervention, Mobile~     Enhancement of Motivation in Schizophrenia (MEMS) and to 2) Test the preliminary~     effectiveness of MEMS compared to a control condition.~   "
38613|NCT03061266|"~     This study will be a randomized controlled trial aimed at examining the effectiveness of the~     in e-health education on shared care program for patients with type 2 diabetes mellitus~     (T2DM). The experiment will be conducted over 1 year at a regional hospital in Taiwan. The~     research subjects will be excluded 160 patients with T2DM. Subjects assigned to an~     experimental group will receive the integrated care program, whereas those assigned to a~     control group will receive routine care. The membership of e-health education on shared care~     program is established by different type's professionals including diabetes physicians,~     pharmacists, dietitians and diabetes health teacher. Glycated hemoglobin (HbA1c) of subjects~     in both groups will be measured at three time points including 1 month before the experiment,~     and 2 and 5 months after the experiment. The self-management conditions and quality of life~     of the subjects will be also recorded using relevant scales.~   "
38614|NCT03061253|"~     The large current uptake of e-cigarettes (2.8 million U.K. users in 2016; 26), the continuous~     involvement of e-cigarettes (which potentially affects their contents as well), the~     uncertainty about their medium- and longer-term effects, and the need to promote smoking~     cessation as means of reducing Cardiovascular disease, dictate that more research is urgently~     needed. Research exploring the impact of e-cigarettes on cardiovascular function/ health has~     been requested by the European Parliament, the British Medical Association, regulatory~     agencies, clinicians and researchers, as there is currently no consensus within the smoking~     cessation community as to the potential impact of e-cigarettes. With e-cigarettes being~     successful in replacing traditional cigarettes (i.e. up to 42% within a month), such studies~     should not only be efficacy-focused, but should also explore the physiological effects of~     e-cigarettes, as preliminary work in the field is contrasting and limited, in both the acute-~     and longer-term timeframe. Furthermore, as e-cigarettes are not simple nicotine-based~     products, the general public, researchers and government agencies cannot rely on the existing~     research exploring the effects of nicotine on the cardio-vasculature (e.g. coronary and~     peripheral vasoconstriction, intravascular inflammation and deregulation of cardiac autonomic~     function as well as inhibition of microcirculation). Thus, the lack of direct evidence -~     which would clarify the degree of safety of e-cigarettes for the user's vascular system and~     determine their longer-term cardiovascular disease risk - increases the need for research in~     the field.~      Such studies will supply in-depth information to service-users and policy-makers, especially~     as the recently-initiated U.K.'s Medicines and Healthcare Products Regulatory Agency~     validation of e-cigarettes will increase likelihood of their introduction in smoking~     cessation clinics.~      This study will bridge the existing knowledge gap and inform the general public, the~     scientific and the smoking cessation community in respect to the physiological (e.g.~     cardiovascular health) and participants' experience of both nicotine-inclusive and~     nicotine-free, e-cigarettes (when combined with behavioural change support) and compare it~     against a currently NHS-applied smoking cessation pathway that combines Nicotine Replacement~     Therapy and behavioural change support. This will allow future research to advance and~     optimize the pharmacological treatment of tobacco and nicotine dependence, by taking into~     consideration the study's physiological and Health Economics' findings.~   "
38615|NCT03061240|"~     This study is the second phase of a research project called Smart Pain Assessment Tool based~     on Internet-of-Things. During the course of this project, a smart pain assessment tool (SPA)~     to detect and assess pain employing behavioural and physiologic indicators will be developed.~     We aim to assess pain based on changes in electromyographic (EMG) activity in facial muscles,~     i.e. changes in facial expressions and simultaneously use physiologic signs such as heart~     rate, respiratory rate and galvanic skin response as adjuvant measures to develop an~     algorithm for pain assessment in critically ill patients.~   "
38616|NCT03061227|"~     The investigators previously characterized a phenotype with non-suppressed glucagon at 120~     minutes after standardized oral glucose load. This phenotype is associated with healthy~     metabolic traits such as lower BMI, higher insulin sensitivity and lower liver fat content.~     Glucagon is a pleiotropic hormone that, besides its main action on increasing endogenous~     glucose production, also reduces appetite and increases basal energy expenditure. The aims of~     this study are to i. detect functional differences in the appetite-related central nervous~     system (CNS) areas between the suppressed and non-suppressed glucagon phenotype ii. mimick~     the non-suppressed glucagon phenotype in those participants who suppress glucagon by~     administering a very-low-dose glucagon infusion and retest them.~   "
38617|NCT03061214|"~     This trial is conducted in Africa, Asia, Europe and South America. The aim of the trial is to~     compare the effect of once-weekly dosing of two dose levels of semaglutide versus sitagliptin~     100 mg once-daily on glycaemic control after 30 weeks of treatment. Subjects will remain on~     their stable pre-trial metformin.~   "
38618|NCT03061201|"~     The purpose of the study is to evaluate the safety, tolerability and time-course profile of~     FVIII activity levels with adaptive doses of SB-525.~   "
38619|NCT03061188|"~     The purpose of this research study is to determine the highest and safest dose of the~     experimental drug veliparib when combined with nivolumab. We will also study how safely this~     combination of medication can be given in advanced cancer and lymphoma and benefits of~     receiving this therapy. Nivolumab is currently approved in certain cancers such as melanoma,~     lung cancer and kidney cancer. Veliparib is not yet approved for use in the United States,~     and is considered experimental. Veliparib inhibits (blocks) the activity of the enzyme PARP.~     This blocking activity may prevent the cancer cell from repairing itself and resume growing.~     Nivolumab increases T cells in your immune system, which allows your immune system to attack~     the cancer. We think the combination of these drugs will be more effective against your~     cancer.~   "
38620|NCT03061175|"~     This pilot randomized clinical trial studies how well a web-based decision aid works in~     improving informed decisions in patients with stage 0-IIIA breast cancer considering~     contralateral prophylactic mastectomy. A web-based decision aid may help doctors determine~     how patients make decisions about whether or not to have contralateral prophylactic~     mastectomy.~   "
38621|NCT03061162|"~     This phase II trial studies the side effects and response of pulsed low dose rate radiation~     therapy in treating gastric cancer patients with peritoneal metastasis.~   "
38622|NCT03061149|"~     Carpal tunnel syndrome is considered to be the most common entrapment neuropathy.~     Conservative treatment is recommended in the mild and moderate stage of CTS. The aim of this~     trial is to evaluate the effectiveness of physical therapy modalities in carpal tunnel~     syndrome.~   "
38623|NCT03061136|"~     Cognitive deficits are some of the most prominent and disabling symptoms of schizophrenia.~     Evidence suggests that schizophrenia involves alterations to the functioning of a neural~     system under the control of a brain chemical called GABA. The present project will compare~     the effects of low-dose clonazepam (at a sub-sedating dose) to placebo, for effects on GABA-~     modulated brain activity measured by EEG, and associated cognitive processes in people who~     have schizophrenia.~   "
40167|NCT03040960|"~     The most commonly identified organism for Surgical Site Infection (SSI) in orthopedic surgery~     is Staphylococcus aureus but risk factors for mono microbial S.aureus SSI are not well-known.~     The aim of this study was to evaluated the incidence rate of S. aureus SSI over the years and~     risk factors of these infections in a french University Hospital.~   "
38624|NCT03061123|"~     The risk of stroke is markedly elevated in patients with atrial fibrillation (AF). Oral~     anticoagulation (OAC) is indicated in individuals with moderate and high risk of stroke to~     the disadvantage of an increased burden from bleeding. Adequate knowledge of this disorder~     and understanding the benefits and hazards of antithrombotic treatment are essential to~     incorporate patient´s values and preferences in these decisions. This will further improve~     acceptance of recommended therapy and augment compliance with OAC.~      The objective of this investigation is to compare patient´s perceptions and physician´s~     assessments of benefits and risks of OAC.~   "
38625|NCT03061110|"~     Prospective, single center, double armed, randomized treatment with observation only~     (standard of care) control group. Subjects receiving study treatment will have 6 months of~     study follow-up. Stromal vascular fraction (SVF), an adipose-derived tissue preparation, will~     be injected into salivary glands to determine safety and efficacy to restore saliva~     production in head and neck cancer patients with chronic xerostomia resulting from radiation~     therapy.~   "
38626|NCT03061097|"~     This study, a Randomized controlled trial of Autologous microbiome reconstitution to prevent~     Colonization by antibiotic rEsistant bacteria (RACE), seeks to investigate the safety,~     feasibility and the role of autologous fecal microbiota transplantation (FMT) for the~     prevention of antibiotic resistant bacteria (ARB) through microbiome restoration.~   "
38627|NCT03061084|"~     A transitional Urology database was created in parallel with National Spina Bifida registry~     to follow patients with complex congenital urogenital anomalies and be able to prospectively~     evaluate them. The investigators obtained the standardized questionnaires to collect~     long-term data regarding patients' genitourinary status including urine and fecal continence,~     sexuality, fertility, and pelvic health.~   "
38628|NCT03061071|"~     This study is a prospective, multi-center, randomized crossover of the NightBalance SPT~     compared to APAP for the treatment of Positional Obstructive Sleep Apnea (POSA).~   "
38629|NCT03061058|"~     Tumor messenger ribonucleic acid (mRNA) expression levels may have a promising role as~     potential predictive biomarkers for chemotherapy.~      Peritoneal carcinomatosis appears to be the most common pattern of metastasis or recurrence~     and is associated with poor prognosis in gastric cancer patients. Intraperitoneal~     chemotherapy is widely accepted strategy in the treatment of peritoneal dissemination.~      In this study, our aim is to evaluate the impact of individualized selection of~     chemotherapeutics and intraperitoneal combined with system chemotherapy on overall survival,~     disease free survival, response rate, and safety of advanced gastric cancer patients.~   "
38630|NCT03061045|"~     The aim of the proposed project is therefore to utilize the CEUS technique to assess cerebral~     perfusion changes before and after ventricular shunting in neonatal cases of PHH. The~     expectation of the proposed project is to validate statistically significant cerebral~     perfusion differences before and after shunting in neonates with PHH, as a preliminary~     feasibility study prior to conducting a large scale, prospective clinical trial incorporating~     therapeutic interventions using the CEUS technique.~   "
38631|NCT03061032|"~     Hepatitis C virus (HCV) infection with around 0.5% and 2.2% prevalence in Iran and world is~     one of the public health problems resulting in chronic liver disease, cirrhosis and~     hepatocellular carcinoma. All cases of chronic HCV infections are candidates of treatment to~     prevent advanced liver diseases. The previous Pegylated-interferon and Ribavirin therapy was~     not efficient in all cases and results in numerous number of side-effects. Introduction of~     direct acting antiviral agents (DAAs) such as Sofosbuvir and Ledipasvir make the eradication~     of HCV possible however these regimens are not affordable and available in developing~     countries. The generic DAAs are manufactured in many of these countries such as Iran to~     provide the treatment with reasonable price.~   "
38632|NCT03061019|"~     Myofunctional therapy has been shown to be effectively reduce symptoms of paediatric sleep~     apnea. As the effectiveness of reeducation relies on parental involvement and child's~     compliance, the investigator's research question was to evaluate two methods of myofunctional~     therapy (daily oral exercices versus a flexible oral appliance, both in combination with~     nasal hygiene), compared to nasal hygiene alone (control group).~   "
38633|NCT03061006|"~     Patients will be screened at Intermountain Medical Center and at Intermountain-affiliated~     anticoagulation clinics in the Salt Lake City region. Patients with non-valvular atrial~     fibrillation will be considered for study. After written informed consent is obtained,~     subjects who meet eligibility criteria will be randomized 1:1 to 2 treatment arms: Group 1:~     Dabigatran etexilate (150 mg BID if CrCL > 30 mL/min, or 75 mg BID if CrCL > 15 to 30 mL/min~     or per USPI; and Group 2: Warfarin (Dose-adjusted (INR 2.0 - 3.0). Assessment of kidney~     function every 6 months will be done for Group 1. Standard warfarin follow-up and education,~     based upon system criteria, will be done for Group 2. All subjects will be followed for 24~     months, and will be assessed at 1-week, then 3-, 6-, 12-, 18- and 24-months~     post-anticoagulation visits as well as other visits deem necessary for clinical care. All~     subjects will undergo protocol-specified laboratory tests and will complete 6 standard,~     validated questionnaires at each follow-up visit following the week 1 visit, except at the~     3-month visit when only one questionnaire will be administered. To determine brain volume and~     characteristic changes representative of micro-bleeding, the first 10 subjects in each~     treatment group who are willing and able to undergo the procedure will participate in a MRI~     sub-study. The cranial MRI will be done at baseline and at 24-months post-anticoagulation on~     this sub-group.~   "
38634|NCT03060993|"~     A growing body of physiological evidence now exists to support a potential role for inhaled~     cannabis in the medical management of adults with chronic obstructive pulmonary disease~     (COPD), particularly as it may related to improving pulmonary function, alleviating the~     symptom of breathlessness and improving exercise endurance. The purpose of this randomized~     double-blind crossover trials is to evaluate the efficacy and physiological mechanism(s) of~     action of inhaled vaporized cannabis targeted to relief of physical activity-related~     breathlessness and exercise endurance in symptomatic patients with severe-to-very severe~     COPD.~   "
38635|NCT03060980|"~     A Phase 3b, open-label, randomized, multicenter, efficacy, safety, and tolerability study of~     ITCA 650 compared to Empagliflozin and to Glimepiride, as add-on therapy to Metformin in~     patients with Type 2 diabetes.~   "
40179|NCT03040804|"~     To establish the safety of radiotherapy in the treatment of advanced hidradenitis~     suppurativa. Patients will receive radiotherapy treatment over one week and then they will be~     followed for the next three months.~   "
38636|NCT03060967|"~     Major depression is a frequent psychiatric disorder with an estimated lifetime prevalence of~     16-17% in the general population. Although its pathophysiology is not completely understood,~     a large body of literature pleads for a causative role of disturbances in reward processes,~     referring to: i) the hedonic sensation (i.e. liking) defined by the pleasure felt after~     exposure to appetitive stimuli, and ii) the motivation (i.e. wanting) represented by the~     ability to initiate and maintain behavioral responses oriented toward appetitive stimuli. the~     investigators have therefore developed and tested a new experimental computer-based and~     easy-to-use test intended to provide an objective and quantitative measurement of both~     hedonic and motivational states in humans. According to the task, the subjects are asked to~     view and to compare two stimuli, an appetitive one (food pictures) and its devalued~     counterpart (food pictures in greyscale), at each trial, assessing either the size (task A)~     or the duration of presentation (task B). From these considerations, the present project aims~     at using our novel tool to: i) assess the hedonic and motivational state in subjects with~     major depression, ii) compare their responses with healthy volunteers. The present project~     should demonstrate that the behavioral tests validated in our laboratory are relevant~     experimental tools for the diagnostic/clinical assessment and for the phenotypic~     characterization of depressed patients. The application of the test in the therapeutic~     context could add further information about the efficacy and relevance of the chosen therapy.~   "
38637|NCT03060954|"~     Interventional, Multicentre, controlled, randomized, single blind, twoarmed non-inferiority~     trial~   "
38638|NCT03060941|"~     A randomized multi-component physical activity intervention for breast cancer survivors.~   "
38639|NCT03060928|"~     Evaluation of clinical and radiological outcomes in patients undergoing Arthroscopic Rotator~     Cuff Repair with standard treatment compared to patients receiving biological stimulation~     with micro-perforations or with the combination of micro-perforations and use of Artelon®~     Tissue Reinforcement, a synthetic device based on degradable polyurethaneurea.~      The investigators believe that this kind of tendon-to-bone healing stimulation with the two~     proposed methods can increase the repair quality by significantly decreasing the lesion~     recurrence rate (currently described for 15% of patients) and can improve various parameters~     such as pain, range of motion and strength, thereby hastening the return to daily activities~     and psycho-physical well-being.~   "
38640|NCT03060915|"~     Those patient's that come to the sleep unit and that accept to participate in the study will~     undergo a polysomnography with the extra of an actigraphy placed in their no dominant arm~     wrist. The outcomes that will be analyzed are:~      Time in bed, assumed sleep time, wake time, sleep efficiency, sleep latency, light's~     on/light's off~   "
38641|NCT03060902|"~     Offspring of mothers with Borderline Personality Disorder (BPD) are at serious risk for~     developing mental illness at every stage of their life, and yet little is known about how~     this risk is transmitted. This study will leverage Dialectical Behavior Therapy Skills as an~     experimental intervention to determine if preschool emotion regulation develops more rapidly~     as a result of improvements in mothers' ability to regulate her own emotions. The knowledge~     from this study will identify a modifiable pathway by which maternal BPD places offspring at~     risk for later mental disorders and will quantify how much improvement in children's ability~     to regulate their emotions can be achieved by treating mothers alone.~   "
38642|NCT03060889|"~     Tranexamic Acid Use in Elective Cesarean Section for Women With Placenta Previa~   "
38643|NCT03060876|"~     This register study collects data of patients with proximal humerus and humerus shaft~     fractures to monitor the healing process by assessing shoulder function and quality of life~     according to the treatment method (operative or conservative management).~   "
38644|NCT03060863|"~     The goal of this project is to measure childhood self-regulation targets known to be~     associated with obesity risk and poor adherence to medical regimens and to assess whether~     intervening on these mechanisms can improve self-regulation. The investigators will do so in~     a pre-existing cohort of low-income school-age children.~   "
38645|NCT03060850|"~     This is an open label, dose escalation, phase I study to determine the recommended Phase 2~     dose (PR2D) by assessing the DLT, safety and efficacy of AC0010 in patients with B-cell~     lymphoma.~   "
38646|NCT03060837|"~     In patients undergoing RIRS for kidney stone, we aim to show the effect of single lung~     ventilation with a double lumen tube on operative (operation scope duration, perforation,~     hemorrhage, etc. complications) and postoperative parameters (stone-free rates, complications~     like postoperative hemorrhage and fever, hospital stay, etc.) and to show changes in renal~     stone position during simultaneous normal ventilation and single lung ventilation.~   "
38647|NCT03060824|"~     During the use of Cardiopulmonary Bypass (CPB) for cardiac surgery there is an instant~     mixture of the patient's blood and the fluid needed to fill the extracorporeal circuit before~     use. This will change the composition of the body fluids. This study aims to plot these~     changes in regard to particle concentration (osmolality).~   "
38648|NCT03060811|"~     Trimethylamine N-oxide (TMAO) is a small organic compound naturally present in fish and~     seefood or generated by the bacterial breakdown of dietary phosphatidylcholine and~     carnitine-containing foods within the human gut microbiome. Elevated serum TMAO was~     previously reported to be associated with an elevated risk for cardiovascular events.~      Aim of this study was to investigate the association between plasma levels of TMAO with the~     Mediterranean diet in a cohort of healthy adults.~   "
38649|NCT03060798|"~     General anesthesia can affect tissue oxygen saturation and microcirculatory reactivity.~     However, the differences in microcirculation caused by anesthetic methods have not been well~     studied. Near-infrared spectroscopy (NIRS) measures peripheral tissue oxygen saturation~     noninvasively and can be used in conjunction with vascular occlusion (VOT) experiments. The~     purpose of this study was to examine the changes in NIRS derived tissue oxygen saturation~     (StO2) and microcirculatory reactivity by VOT after inhalation anesthesia in healthy~     population.~      This prospective, observational study will be performed on 57 healthy patients who had~     undergone elective surgery under volatile general anesthesia. The investigators measure StO2~     and microvascular reactivity using NIRS combined with vascular occlusion test (VOT). The~     parameters were performed twice per patient, before and after the induction of anesthesia.~      Occlusion slope and recovery slope during VOT will be compared before and after anesthesia.~     Moreover, the changes depend on the age will be analyzed.~   "
38651|NCT03060772|"~     This study is a single center, open-label, randomized clinical trial to determine the effect~     of pioglitazone (PIO) treatment on alveolar macrophage immune function, redox stress, and~     NADPH oxidase expression in outpatient alcoholic subjects. The researchers will recruit a~     cohort of otherwise healthy patients with an alcoholic use disorder from the Substance Abuse~     Treatment Program at the Atlanta Veterans Affairs (VA) Medical Center and randomize them to~     receive the usual treatment for two to four weeks or to the usual treatment plus PIO~     treatment for two to four weeks. There will also be a healthy control group (matched on age,~     gender, and smoking status) that will receive no treatment. To measure the effect of~     pioglitazone, participants will undergo a bronchoscopy before taking the study drug and then~     again 2-4 weeks later to look for changes. The bronchoscopy will allow researchers to obtain~     fluid from the lungs to see how well their immune cells respond to bacteria by determining~     phagocytic capacity.~   "
38652|NCT03060759|"~     This prospective study will randomize 1:1 people living with multiple sclerosis-associated~     fatigue to one of two spectra of light therapy. Each participant will be asked to use the~     light box twice daily at home or at the workplace at preset hours during the day for a total~     of four weeks. Participants will be asked to record their fatigue on standard measurement~     scales before, during, and after the use of the light therapy box. The investigators~     anticipate a reduction in self-reported fatigue following the use of the light box therapy of~     a particular spectrum of light among people living with multiple sclerosis.~   "
38653|NCT03060746|"~     The primary objective is to obtain stool samples from pre-therapy subjects already undergoing~     evaluation for an H. pylori infection by upper esophagogastroduodenoscopy (EGD) and gastric~     biopsy.~   "
38654|NCT03060733|"~     The primary objective is to obtain stool samples from post-therapy subjects already~     undergoing evaluation for an H. pylori infection by upper esophagogastroduodenoscopy (EGD)~     and gastric biopsy.~   "
38655|NCT03060720|"~     This research study is looking at people with cancer of the pancreas to find clinical factors~     that can explain the presence of genetic mutations~   "
38656|NCT03060707|"~     The research is to find out whether continuous infusion of rocuronium requires more or less~     amount of rocuronium, per kilogram and per hour, than bolus administered rocuronium during~     noncardiac surgery.~   "
38657|NCT03060694|"~     The purpose of this study is to compare the severity of NAFLD in diabetic patients to that in~     non-diabetic patients.~   "
38658|NCT03060681|"~     The most commonly used technique to anesthetize patients scheduled for thoracic or lumbar~     spine surgery is general anesthesia. Analgesic techniques vary from the use of neuraxial~     techniques like epidural, intrathecal, or caudal analgesia, nerve root infiltration to the~     use of systemic opioids, Paracetamol, non-steroidal anti-inflammatory drugs (NSAID), steroids~     and gabapentinoids .~      In 2015, a promising regional analgesia technique was reported, that targets the dorsal,~     rather than ventral, rami of the thoracolumbar nerves as they pass through the paraspinal~     musculature, and called this a thoracolumbar interfacial plane block (TLIP).~   "
38659|NCT03060668|"~     In this prospective randomized controlled trial the investigators intend to compare the use~     of a nutritional therapy based on caloric intake determined by indirect calorimetry and a~     high protein intake (2.0 to 2.2 g/kg/day) with a nutritional regimen based on 25 Kcal/kg/day~     and protein intake usually recommended to critically ill patients (1.4 to 1.5 grams/kg/day).~   "
38660|NCT03060655|"~     The different proportion samples of PLGA-Mg were made in this study. Then, they would be~     placed in the femoral condyle of the New Zealand rabbits. The appropriate proportion of~     PLGA-Mg is obtained after the experiment, which will be used to make the plate or screw to~     fix the fragments. Then, the clinical role for bone will be assessed.~   "
38661|NCT03060642|"~     This study aims to elucidate the relationship between the microbiome, inflammation, and the~     microenvironment in Barrett's esophagus (BE) and esophageal adenocarcinoma (EAC), with the~     end goal of developing a non-endoscopic testing strategy based on pathogenic factors to~     identify patients at highest risk for EAC. To accomplish this the investigators will enroll~     100 patients with known BE (50 with dysplasia or EAC) and 50 subjects without BE undergoing~     upper endoscopy. Prior to endoscopy each subject will undergo three minimally invasive~     potential screening and surveillance tests: saliva (oral microbiome), breath test (exhaled~     volatile organic compounds), and tethered capsule sponge sampling (methylated DNA markers).~     The study will evaluate these novel tests in combination with clinical and anthropometric~     factors to describe an optimal strategy for BE screening and monitoring.~   "
38662|NCT03060629|"~     The primary purpose of this study is to assess the preventive vaccine efficacy (VE), safety~     and tolerability of a heterologous prime/boost regimen utilizing Ad26.Mos4.HIV and~     aluminum-phosphate adjuvanted Clade C gp140 for the prevention of Human Immuno Virus (HIV)~     infection in HIV-seronegative women residing in sub-Saharan Africa from confirmed HIV-1~     infections diagnosed between the Month 7 and Month 24 visits.~   "
38663|NCT03060616|"~     The principal manifestation of hemorrhoidal disease is bleeding; however the severity~     evaluation is today based on prolapsus (Goligher classification) and bleeding factor is not~     included.~      Even if there was some rare score including bleeding in literature , none of them were~     validated.~      The aim of the study is first validation of bleeding score .~   "
38664|NCT03060603|"~     The purpose of this study to assess the proliferative effects of erythropoetin on human~     endometrium tissue by measuring the endometrial thickness, uterine artery and subendometrial~     blood flow in postmenopausal women.~   "
38678|NCT03060421|"~     As the use of Aquamid Reconstruction as an intraarticular device on humans is a relatively~     novel treatment, it is relevant to assess the safety profile of the device in a safety study~     to evaluate the safety of the device.~      This is a retrospective single center cohort study of patients with osteoarthritis of the~     knee(s) that have been treated for knee OA referred to a clinical evaluation at our~     department.~      The study consists of one clinical visit, at which the patients medical history will be taken~     and upon informed consent adverse events data is collected from medical records.~      The study is retrospective.~   "
40908|NCT03031262|"~     In this open-label, randomized, prospective clinical trial, CBF acute myeloid leukemia (AML)~     patients who have reached CR are randomised into two groups and receive high-dose cytarabine~     (HDAC) or high-dose cytarabine plus chidamide.The safety and efficacy of chidamide is~     evaluated.~   "
38665|NCT03060590|"~     Background. In advanced chronic kidney disease (CKD), multiple metabolic and nutritional~     abnormalities may contribute to the impairment of skeletal muscle mass and function thus~     predisposing patients to the condition of sarcopenia. Herein, we aim to investigate the~     association of uremic toxins and sacropenia. In addition, the prevalence and mortality~     predictive power of sarcopenia, defined by different methods, in a cohort of hemodialysis~     patients.~      Methods. We plan to evaluate 300 HD patients. Sarcopenia was defined as reduced muscle~     function assessed by handgrip strength (HGS <30th percentile of a population-based reference~     adjusted for sex and age) plus diminished muscle mass assessed by different methods: (i)~     midarm muscle circumference (MAMC) <90% of reference value (A), (ii) muscle wasting by DEXA~     (B) and (iii) reduced skeletal muscle mass index (<10.76 kg/m² men; <6.76 kg/m² women)~     estimated by bioelectrical impedance analysis (BIA) (C). Serum levels of 3 established uremic~     toxins such as indoxyl sulfate, p-cresol and hippuric acid will be measured. Besides, various~     relevant inflammatory markers will also be assessed. Patients will be followed for up to 3~     years for all-cause mortality.~   "
38666|NCT03060577|"~     ORION-3 is a Phase II, open-label, non-randomized, active comparator extension trial to~     assess the efficacy, safety, and tolerability of long-term dosing of inclisiran and~     evolocumab given as subcutaneous injections in participants with high cardiovascular risk and~     elevated low-density lipoprotein cholesterol (LDL-C).~   "
38667|NCT03060564|"~     To evaluate patient function, radiographic changes and complication rates of acute~     coracoclavicular (CC) joint reconstruction with and without the use of tendon graft as an~     augmentation to repair.~   "
38668|NCT03060551|"~     This study outlines the safety of the autologous SVF cells injection in the hands of patients~     with SSc. Preliminary assessments at 6 months will suggest potential efficacy needing~     confirmation in a randomised placebo-controlled trial on a larger population~   "
38669|NCT03060538|"~     This is a Phase Ib, randomized, blinded, placebo-controlled, multiple ascending−dose study of~     the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) effects of BFKB8488A~     in participants with Type 2 diabetes mellitus. A maximum of approximately 140 participants~     will be enrolled across multiple sites in the United States. Participants will be randomly~     assigned to receive study drug (active BFKB8488A or placebo). The study will consist of a~     screening period (up to 8 weeks), a 12-week treatment period, and a 6-week follow-up period.~     Participants may come to clinic for an optional pre-screening visit.~   "
38670|NCT03060525|"~     The purpose of the Deaf Weight Wise 2.0 (DWW 2.0) study is to test an evidence-based,~     comprehensive program to modify obesity-related health behaviors with Deaf people ages 21 to~     70 who use American Sign Language (ASL) as their primary language. Participants will be~     randomized to one of four arms: immediate intervention vs. intervention delayed one year, and~     in-person group intervention vs. individual intervention delivered via videophone. The~     investigators' primary hypothesis is that participants in the immediate DWW 2.0 intervention~     will increase their physical activity and reduce their caloric intake and body weight~     compared with those in the delayed intervention group (no intervention yet).~   "
38671|NCT03060512|"~     The purpose of this study is to determine whether patients with opioid induced constipation~     prefer treatment with naloxegol (Movantik) or with Polyethylene Glycol 3350.~   "
38672|NCT03060499|"~     Protocol Synopsis~      Protocol title: Post thyroidectomy myocardial function Purpose: Evaluation of the effects of~     total thyroidectomy on myocardial function Design: Prospective, single-center, cohort study~     Patient Population: Male or female subjects 18 years of age or older who are scheduled for~     total thyroidectomy No. of Subjects: 50 patients, estimated up to 12 months to enroll~     Duration of Treatment: Operation Duration of Follow-up: After discharge, the patients will be~     re-evaluated at three (3), six (6) and twelve (12) months in the outpatient clinic.~      Endpoints: To evaluate the changes in the myocardial function after the removal of the~     thyroid gland.~   "
38673|NCT03060486|"~     Blood contamination, such as apical microleakage, of root canal during preparation can be a~     major problem in endodontics. The purpose of this investigation was to evaluate the~     hemostatic properties of sulfonic/sulfuric acid solution used during root canal therapy in~     teeth with irreversible pulpitis.~   "
38674|NCT03060473|"~     Preterm premature rupture of membranes (PPROM) complicates 4% of pregnancies annually. This~     pregnancy complication is a major contributor to preterm births and results in neonatal~     morbidity and mortality. The current standard of care for PPROM subjects between the~     gestational age of 24 weeks and 0 days and 33 weeks and 6 days, is to administer ampicillin~     and erythromycin for a total of 7 days. Erythromycin can cause GI upset and some subjects do~     not tolerate this regimen over the course of 7 days. In addition, there is a national~     shortage of erythromycin, and published expert opinion proposed to use a second-generation~     macrolide (azithromycin) instead of erythromycin. Azithromycin can be taken once daily, is~     cheaper than erythromycin and has less GI upset adverse effects. The investigators' objective~     is to compare the effectiveness of the 2 regimens in prolonging pregnancy after PPROM. The~     investigators' working hypothesis is that there is no measurable difference in the primary~     outcome between the group randomized to the azithromycin regimen versus the group randomized~     to the erythromycin regimen.~   "
38675|NCT03060460|"~     The study evaluates whether routine use of ultrasound for sheath insertion during radial or~     femoral angiography or angioplasty has any impact on: number of punctures, patient~     discomfort, procedural length, successfull procedure or ideal vessel puncture.~   "
38676|NCT03060447|"~     The primary objective of this study is to evaluate the safety and tolerability of a 10-dose~     regimen of vesatolimod in HIV-1 infected controllers on antiretroviral treatment (ART) and~     during analytical treatment interruption (ATI) following vesatolimod dosing.~   "
38677|NCT03060434|"~     The objective of this prospective controlled crossover study is to evaluate the efficacy and~     safety of pentoxifylline per os (800 mg daily) in the management of lumbar radiculopathy~   "
38679|NCT03060408|"~     In this retrospective cohort study, the investigators reviewed and analyzed the electronic~     medical records of consecutive patients who underwent distal pancreatectomy either via~     laparotomy or laparoscopy. Intraoperative fluid administration amount, postoperative~     complications, length of hospital stay, and readmission rate were evaluated. The total fluid~     amounts were calculated using the sum of colloids multiplied by 1.5 or 2.0 and crystalloids.~   "
38680|NCT03060395|"~     There is increasing evidence that a number of people experience moderate milk intolerance~     characterised by increased gas production, bloating and abdominal cramp, which can neither be~     attributed to lactose intolerance, nor to milk protein allergy. Milk digestion can lead to~     the formation of bioactive peptides, one of which derived from a mutated gene variant (A1)~     coding for milk beta-casein has been associated with increased gastrointestinal inflammation~     and poor gastrointestinal function. In this study, we hypothesise that consumption of~     non-mutated A2 milk will improve gastrointestinal symptoms in non-lactose milk intolerant~     individuals.~   "
38681|NCT03060382|"~     The investigators randomly divided the knee osteoarthritis patients met the inclusive~     criteria into two groups (study group and control group). Placement of balanced buttress~     absorbable spacer and total knee arthroplasty were conducted. The clinical outcome of two~     groups were compared in this study.~   "
38682|NCT03060369|"~     This pilot study aims to examine the relationship between continuously measured CareGuide™~     muscle oxygen saturation (SmO2), tissue pH and data provided from standard monitoring~     techniques during the care of subjects with suspected established (Cohort A) or emerging~     (Cohort B) shock in the intensive care unit (ICU).~   "
38683|NCT03060356|"~     This is a pilot study to evaluate feasibility, safety, and preliminary evidence of efficacy~     for intravenously administered, RNA electroporated autologous T cells expressing MET chimeric~     antigen receptors with tandem TCRζ and 4-1BB (TCRζ /4-1BB) co-stimulatory domains (referred~     to as RNA CART-cMET) in patients with advanced melanoma or breast carcinoma.~   "
38684|NCT03060343|"~     A single-center, open-label pilot study to determine the safety, tolerance and engraftment~     potential of zeushield cytotoxic T lymphocytes in subjects with PD-L1+ positive non-small~     cell lung cancer.~   "
38685|NCT03060330|"~     Obstructed defecation syndrome (ODS) is a common problem in women. Rectal prolapse and~     rectocoele are frequently identified in patients with ODS. Surgery is the only definite~     treatment for those patients and is preferably performed minimally invasive. The most used~     procedures are laparoscopic ventral mesh rectopexy (LVMR) and stapled trans-anal rectal~     resection (STARR). However, high-level prospective studies on treatment strategies for ODS~     currently are lacking and, thus, no consensus exist regarding the optimal treatment for~     patients with ODS. This study aimed to compare LVMR alone and LVMR combined with STARR~     evaluating functional and anatomical results.~   "
38686|NCT03060317|"~     The purpose of this study is to validate Russian version of Coma Recovery Scale - Revised and~     to assess its psychometric properties.~   "
38687|NCT03060304|"~     Cryopreservation of embryos created during fresh IVF cycles provides a less expensive and~     time-intensive opportunity for pregnancy. Ideal endometrium thickness is the key point to~     optimization FET cycle. Researches show that when endometrial thickness is less than 7mm,~     pregnancy rate dropped significantly. Tamoxifen has been reported to be oestrogenic on the~     lower genital tract. Several study on intrauterine insemination or ovulation induction~     suggest that tamoxifen may be a promising alternative for patients with thin endometrium.~     Based on this ,we want to evaluate the effects of tamoxifen on endometrial thickness and~     pregnancy outcome in women who failed to develop an adequate endometrial thickness in~     previous frozen embryo transfer cycle twice or even more times and willing to have another~     attempt.~   "
38688|NCT03060291|"~     The purpose of this study is to develop and evaluate the effectiveness of a web-based version~     of the Family Check-up (FCU). The FCU is a school-based family-centered intervention that has~     been developed over the past 20 years and tested across the United States with diverse~     populations. It focuses on enhancing parenting skills and family management in early~     adolescence. The FCU has been shown to be highly effective at reducing adolescent problem~     behavior, achievement problems, depression, and substance use over an extended period of~     time.~      In the original FCU, parents complete an assessment that evaluates family strengths and~     challenges. They then receive feedback from a family consultant about how their data compare~     to other families with children of the same age. As part of this feedback session, the~     consultant helps motivate parents to make changes at home that will positively impact their~     child and family overall. Parents and consultants decide together which child behaviors they~     most want to see change. The consultant then works with parents to enhance relevant parenting~     and family management skills.~      Despite the demonstrated effectiveness of this intervention, few schools have the resources~     and staffing to implement it without substantial support. It seems, then, that schools would~     benefit from an online package that requires fewer school resources to implement. The~     FCU-Online is designed to incorporate the successful components of the original FCU while~     reducing the burden on schools. And, because it is accessed online, parents can utilize this~     resource at a time and location convenient to them.~      In this study, 300 families will be randomly assigned to one of three conditions: a web/~     mobile-only version of the FCU, a web/mobile + coach version, or middle school as usual.~     Research on mental health interventions delivered over the internet suggests that a coach or~     in-person contact enhances outcomes. However, programs that require no coaching or~     in-person contact are cheaper and easier for schools to deliver. Therefore, a web/~     mobile-only version may allow more schools to deliver the intervention to a greater number of~     families and children. Thus, investigators will test the relative effectiveness of a coach~     version versus an online-only version at improving key parenting skills. It is predicted that~     changes in parenting will lead to reductions in risk behavior, such as problem behavior at~     school and substance use.~   "
38689|NCT03060278|"~     The proposed pilot study seeks to address the smoking cessation treatment needs of~     underserved smokers with limited resources by evaluating the feasibility and preliminary~     efficacy of a smartphone delivered automated video-assisted smoking treatment (AVAST). AVAST~     will enable smoking cessation treatment content to be presented with voice/audio, images,~     videos, and text in an interactive, structured format anytime and anywhere. Participants will~     be recruited from the Urban Mission, a non-profit food and resource center that serves~     approximately 20,000 people each year in the Oklahoma City metro area.~   "
38690|NCT03060265|"~     Protective analgesia in caesarean section using intravenous paracetamol: A prospective~     randomised controlled trial. Cesarean section a common surgical procedure in women. The~     parturients undergoing CS experience severe to moderate postoperative pain. Pain relief is~     very important to the patient as it causes discomfort which affects hemodynamic~     intraoperative and increases the risk of postoperative complications. Analgesia is crucial to~     postoperative recovery.~      Aims: To investigate the efficacy of combined administration of paracetamol, as protective~     multimodal analgesia, and standard spinal anesthesia in the reduction of postoperative pain~     following cesarean section.~      Sixty adult Parturients undergoing CS will participate in a single-centered, randomized,~     double-blinded, placebo-controlled trial divided into 2 groups 30 each. The intervention~     group will receive 1 gr of intravenous paracetamol in 100 ml normal saline only 15 minutes~     prior to spinal anesthesia induction. The control group will receive 100 ml normal saline IV~     identical in size and shape and manner to the experimental group, 15 minutes prior to~     induction of spinal anesthesia. We will measure postoperative Visual Analog Scale (VAS) pain~     score, postoperative time to analgesia in PACU and number of postoperative analgesic doses~     within 24 hours.~   "
38694|NCT03060213|"~     Subjective well-being refers to people's level of satisfaction with life as a whole and with~     multiple dimensions within it. Interventions that promote subjective well-being are important~     because there is evidence that physical health, mental health, substance use and health care~     costs may be related to subjective well-being. This randomized controlled trial will evaluate~     an online intervention, named Fun For Wellness (FFW), designed to promote well-being skills~     and self-efficacy in six domains of life: interpersonal, community, occupational, physical,~     psychological, and economic (I COPPE). The Usual Care (UC) control group will be wait-listed.~     Five hundred (500) community-based adult patient participants will be enrolled. We~     hypothesize that compared to the UC group, intervention group participants will show greater~     improvement in their overall subjective well-being, domain-specific well-being,~     health-related quality of life, and well-being self-efficacy.~   "
38695|NCT03060200|"~     The aim of this study is to test a newly developed app, firmly grounded in Cognitive~     Behavioural Therapy (CBT) theory of depression, to determine primarily if this app is~     clinically useful in decreasing moderate depressive symptoms when compared with an active~     placebo. Additionally, we are interested in the app's potential to contribute to the~     reduction of general negative affect, increasing positive affect, and boosting satisfaction~     with life. Last, but not least, we aim to verify if the usage of the tested app can modify~     depressogenic cognitions.~   "
38696|NCT03060187|"~     The purpose of this observational study is to evaluate the usefulness of Kansas University~     airway exam score (KU score) in predicting difficulty of placement of a breathing tube into~     the windpipe.~   "
38697|NCT03060174|"~     Postoperative cognitive dysfunction describes a condition where cognitive functions such as~     attention, perception, concentration, learning, abstract thinking and problem solving are~     impaired postoperatively. These changes can be resolved after weeks and months, but in some~     cases may be permanent.~      The aetiology is multifactorial. One risk factor for developing POCD is the occurrence of~     postoperative delirium.~      A total of 638 consecutive patients will be enrolled in the study. Patients will be followed~     up at 7 days, 3 months and 1 year postoperatively. The cognitive function will be tested and~     compared to tests done before surgery. Postoperatively (from the day of operation until the~     7th day and except of day 6) the grade of sedation; agitation; signs of delirium; pain;~     cardiac; respiratory; renal and infectious complications will be recorded.~      As possible influencing factors, the investigators will document diagnosed depression;~     comorbidities; intraoperative blood loss; length of hospital stay; 1-year-mortality; number~     of operations/anaesthetics undergone after the initial operation.~      Parameters that could trigger either depressive symptoms, neurocognitive dysfunction,~     anxiety, fatigue or lack of concentration will be recorded. These include: anaemia,~     hypercalcaemia, thyroidal gland hormones, electrolytes, creatinine, urea, glomerular~     filtration rate, cortisone therapy and adrenal cortical insufficiency.~   "
38698|NCT03060161|"~     Introduction: The epidemiological transition is one of the factors related to the increase in~     the prevalence of chronic noncommunicable diseases (CNCD), such as cardiovascular diseases,~     diabetes and cancer. Among the risks of risk to the development of CNCD are obesity, smoking,~     alcoholism, sedentary lifestyle and inadequate eating habits, with the last two levels having~     a high impact on gender and disease progression. Objectives: To promote healthy eating habits~     and to combat physical inactivity through nutritional monitoring and regular physical~     exercise, using a competition to stimulate adherence of the institution's employees. Methods:~     The present project is in agreement with the longitudinal study with the work of evaluation~     (anthropometric, body composition, laboratory and food consumption), in the eats of the times~     (at the beginning and end of the four-month intervention period). According to nutritional~     monitoring and individual guidance on regular physical exercise practice over a period of 12~     weeks. Weight reduction, body fat reduction, changes in working methods and eating habits,~     and the relationship to routine physical activity after the intervention period, and are~     retested after six months. Expected results: Reduction of sedentary lifestyle, weight loss~     and body fat, improvement of eating habits, quality of life without working environment and~     health condition of the participants.~   "
38699|NCT03060148|"~     Previous studies have shown that spinal cord stimulation (SCS) may improve cardiac output and~     decrease the risk of ischemic ventricular arrhythmia in animal model and its safety profile~     in human trial. The purposes of this study are to evaluate the feasibility, treatment~     efficacy and safety of SCS in patients with severe symptomatic heart failure (HF).~   "
38700|NCT03060135|"~     There are a number of popular, freely available online interventions targeting hazardous~     alcohol consumption. Unfortunately, most have limited or no published evidence regarding~     their efficacy. Of particular interest is the intervention, 'Hello Sunday Morning.' The~     current project proposes to evaluate its' efficacy employing a RCT, using The Check Your~     Drinking intervention as an active comparator in the trial.~      Participants will be recruited through Amazon's MTurk crowdsourcing platform. Potential~     participants identified as problem drinkers based on an initial survey will be invited to~     complete another survey in 6 months time. Those who agree to be followed-up will be assigned~     by chance to be asked versus not asked to access one of the interventions and then~     recontacted 6 months later to ask about their drinking and their impressions of the online~     intervention. The primary hypothesis to be tested is that participants receiving access to~     any of the online interventions will report a greater level of reduction in number of drinks~     in a typical week between the baseline survey and six-month follow-up as compared to~     participants in the control condition.~   "
38701|NCT03060122|"~     This study will be aimed at assessing the feasibility of a dual-device treatment prior to a~     rehabilitation session for an orthopaedic injury requiring immobilization, and its impact on~     improving outcomes and decreasing the risk for development of neuropathic pain. The~     investigators will evaluate the clinical feasibility and effectiveness of incorporating the~     Alpha-Stim and Inter-X treatment into a standard rehabilitation protocol to address risk~     factors associated with the development of neuropathic pain (i.e., pain, range of motion, and~     skin temperature) as well as its impact on reduced pain medication.~   "
38702|NCT03060109|"~     The purpose of this study is to collect fresh whole blood within 12 hours from suspected mild~     head injury (Glasgow Coma Scale score 13-15) from subjects over the age of 18, to help verify~     that both UCH-L1 and GFAP can be detected with the Philips Minicare POC diagnostic test~     platform.~   "
38703|NCT03060096|"~     Mental health issues in post-treatment adult cancer survivors are associated with multiple~     adverse outcomes and may represent a cancer health disparity for rural survivors. The purpose~     of this study is to test a stepped-care approach tailored to symptom severity based on recent~     American Society of Clinical Oncology guidelines for reducing emotional distress (anxiety~     and/or depressive symptoms) and improving secondary outcomes (sleep disturbance, fatigue,~     fear of recurrence, quality of life) in rural, post-treatment cancer survivors in community~     oncology settings and to examine intervention costs. The resultant intervention will have~     great potential for widespread dissemination since it will be manualized, delivered by~     telephone, and comprised of modules to allow customized treatments for individuals with~     different cancer types.~   "
38704|NCT03060083|"~     The FDA recently gained the authority to regulate the nicotine content of cigarettes. Prior~     research suggests that smokers who switch to very low nicotine content (VLNC) cigarettes~     experience reduced addiction to nicotine and are more likely to quit smoking. Currently, the~     most common method for smokers to reduce their nicotine intake is to reduce their number of~     cigarettes per day (CPD). No research has compared reducing smokers' nicotine intake by~     switching to VLNC cigarettes vs by reducing CPD with regard to decreasing dependence or~     quitting; thus the investigators will examine the two strategies by randomizing smokers to 1)~     switch to VLNC cigarettes or 2) reduce CPD. In addition, all smokers will use the nicotine~     patch to help them reduce their nicotine intake.~   "
38705|NCT03060070|"~     Comparing the analgesic effects of ketamine and dexmedetomidine when added to local~     anesthetic in TAP block for postoperative analgesia after lower abdominal cancer surgery.~   "
38706|NCT03060057|"~     The purpose of this study is to evaluate both short and long term clinical performance and~     safety of the commercially available U2 Knee™ System.~   "
38707|NCT03060044|"~     Pharmacokinetic study comparing Salmeterol/fluticasone Easyhaler products and Seretide Diskus~     50/500 µg/inhalation; a randomised, open, single centre, single dose, crossover study in~     healthy subjects~   "
38708|NCT03060031|"~     This experiment will explore the joint effects of social information, social support,~     associative learning, and oxytocin on the development of placebo analgesia. The investigators~     predict that socially transmitted placebo effects will be enhanced by nasal administration of~     oxytocin, whereas associative learning effects on pain will not be altered by this~     pharmacological manipulation~   "
38709|NCT03060018|"~     Partial blood oxygen and carbon dioxide pressures obtained in critical ill neonates by~     transcutaneous sensors will be compared to respective values obtained by medically indicated~     arterial and capillary blood gas analyses. The influence of blood withdrawal method, sensor~     operational temperature and application time, presence of cyanotic heart malformations and/or~     intra or extra cardiac right to left shunt, vasoactive drugs, elevated non-conjugated~     bilirubin, and skin and soft tissue oedema, skin colour and perfusion conditions will be~     elucidated as well as sensor`s safety. Study duration will be 48 hours with sensors applied~     and additional 4 hours of further surveillance for thermal injury.~   "
38710|NCT03060005|"~     The investigators hypothesize that the dry eye caused by SS may include the evaporative type,~     resulting from the MGD. Furthermore, the investigators hypothesize that both pSS and sSS are~     associated with MGD.To test our hypothesis, we conducted a prospective clinical study in~     patients with SS (both pSS and sSS) and MGD, and the normal population All subjects were~     matched for both age and gender and assessed for tear function and ocular surface signs and~     symptoms.~   "
38711|NCT03059992|"~     This is a multicenter, open label, non-comparator, single arm study to evaluate the efficacy~     and safety of SCY-078 in patients ≥ 18 years of age with a documented fungal disease that has~     been intolerant or refractory (rIFI) to Standard of Care (SoC) antifungal treatment.~   "
38712|NCT03059979|"~     This is a 12 week double-blind randomized placebo controlled trial in which 30 patients with~     very early SSc, fulfilling the Very Early Diagnosis Of Systemic Sclerosis (VEDOSS) criteria~     (9) will be randomized in a 2:1 fashion to receive intravenous methylprednisolone or placebo.~     Three-day treatment courses are given at week 0, week 4 and week 8. The final assessment is~     at week 12, and patients will be followed up to one year after baseline~   "
38713|NCT03059966|"~     The purpose of this study was the evaluation of inflammatory and healing profile after root~     coverage using of Enamel Matrix Derivative. 16 volunteers were selected and submitted to root~     coverage surgery with subepithelial connective tissue graft, with and without enamel matrix~     derivative. The patient screening was based in the following inclusion criteria: bilateral~     recessions in maxillary anterior homologous teeth with aesthetical complaining ou~     hypersensitivity, non-smokers, healthy and no use of any medication that compromises~     periodontal health or healing. The split-mouth randomized model was followed in relation to~     test and control sites. The following clinical parameters were analyzed at baseline and~     6-month post-surgery: recession height, recession width, width of keratinized tissue, probing~     depth, clinical attachment level, and gingival thickness. In addition to the surgical~     analysis, evaluations of the following inflammatory markers were performed: IL-1β, IL -1RA,~     IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL12, IL-13, IL-15, IL-17, EOTAXIN, FGF,~     GCSF, GMCSF, IFN-y, IP-10, MCP-1, MIP 1a, PDGF-bb, MIP 1b, RANTES, TNF-α e VEGF. These~     evaluations were performed at baseline, 7 and 14 days after surgery.~   "
38728|NCT03059758|"~     Most studies to date that have examined the factors underlying math achievement in children~     have focused on basic numerical knowledge. Yet, math skills are clearly not limited to basic~     numerical knowledge and recent behavioral studies suggest a relationship between math and~     deductive reasoning skills. The goal of this study is to determine the neural mediators of~     this relationship using functional magnetic resonance imaging. The investigators will ask~     children from 8 to 14 to complete a standardized math achievement test, and measure their~     brain activity while they process deductive arguments. The investigators will then correlate~     brain activity during reasoning to individual math skills to identify the brain regions in~     which activity during reasoning is modulated by math skill.~   "
38729|NCT03059745|"~     Comparing the use of surgical robotics during a Cholecystectomy, comparing different~     platforms and approaches (multi port verses single port).~   "
41766|NCT03020043|"~     Invasive hemodynamic monitoring in advanced heart failure patients is a relative new option.~     In order to investigate the impact of remote telemonitoring of pulmonary artery pressures on~     mortality and morbidity in a routine clinical setting in germany, the investigators initiated~     this Frankfurt registry.~   "
38714|NCT03059953|"~     For patients with moderate plaque psoriasis who are intolerable to, have a contraindication~     to or have failed classical systemic treatments, the current commonly employed management~     strategy encompasses treatment with biologic agents. The direct and indirect costs of~     biologic treatment, accruing, among others, from the high drug acquisition and administration~     costs, the required baseline safety screening and subsequent routine monitoring as well as~     the potential loss of patients' working hours constitute a significant financial burden on~     the public healthcare system. In light of the above evidence, it appears that in routine care~     apremilast may fulfill an important gap in the treatment armamentarium of psoriasis by~     providing a promising treatment option to be employed prior to biologics, which has~     demonstrated efficacy even in hard-to-treat areas such as the scalp, nails, palms and soles,~     and has a limited manageable safety profile, while being more convenient and cost-effective~     than biologics.~      In view of the scarcity of real-world evidence regarding the impact of apremilast on the~     patients' health-related quality of life (HRQoL) and extent and severity of the disease, and~     under the consideration that the moderate psoriasis patient {defined as [10<body surface area~     (BSA)<20 or 10<psoriasis area severity index (PASI)<20] and 10<dermatology quality of life~     index (DLQI)<20}, naïve to biologic treatment was likely underrepresented in the pivotal~     ESTEEM trials since approximately 30% of the enrolled patients had been previously treated~     with biologic therapy, 28-30% had a baseline PASI score >20, and 48-52% had a BSA >20%, this~     study represents an attempt to examine the impact of apremilast in routine clinical practice~     settings in Greece on the patient with moderate plaque psoriasis when this therapeutic~     strategy precedes biologics in the treatment algorithm.~      Specifically, the present study aims to generate novel real-world evidence on the effect of~     apremilast treatment in biologic treatment naïve patients with moderate plaque psoriasis in~     terms of the patients' HRQoL, patient-perceived benefits of therapy, treatment response rate,~     and impact on nail, scalp and palmoplantar psoriatic involvement and severity of pruritus,~     while concurrently assessing apremilast survival rate and cost per PASI-75 responder in the~     routine clinical practice of Greece.~   "
38715|NCT03059940|"~     The goal of this clinical research study is to offer lung cancer screenings to smokers who~     want to change their smoking behaviors. All eligible participants will receive smoking~     cessation counseling and may be offered at least one form of smoking cessation drug.~     Different forms of counseling (the delivery of counseling and access to counseling) will be~     compared.~      This is an investigational study. Participants on this study will not be prescribed smoking~     drugs directly by the study staff. However, participants in this study may or may not receive~     smoking cessation drugs, depending on what the provider thinks is in the participants best~     interest. All smoking cessation drugs being used are FDA approved and commercially available.~     It is investigational to compare the different forms of counseling participants receive.~      Up to 1260 participants will be enrolled in this study. All will take part at MD Anderson.~   "
38716|NCT03059927|"~     The purpose of this study is to compare three prosthesis designs to compare three prosthesis~     designs for total knee arthroplasty and determine the best option for patients in need of a~     knee replacement.~   "
38717|NCT03059914|"~     The purpose of this investigator-initiated study is to compare new bone formation through~     histomorphometric analysis following maxillary sinus augmentation using two different bone~     graft materials. A total of twenty, sinus augmentation via a lateral approach will be~     performed for subjects requiring sinus augmentation for implant placement and randomly~     divided into 2 groups. These subjects will receive one of two different bone graft materials:~     1) Anorganic bovine bone matrix- InterOss (Group A), 2) Anorganic bovine bone matrix- Bio-oss~     (Group B). At the time of implant placement (eight months after the sinus augmentation~     procedure), two bone biopsies will be collected from augmented site for the histomorphometric~     analysis. The percentage of vital bone will be measured and analyzed statistically, also the~     following will be measured: percentage of non-vital bone, percentage of non-bone material~     (xenograft), and the percentage of connective tissue.~   "
38718|NCT03059901|"~     Despite numerous interventions designed to increase physical activity, few are specifically~     tailored to Latinas, a population where higher rates of obesity, diabetes, and other chronic~     diseases are present. This proposed smartphone app will use location-based services to~     connect Latinas with one another in order to improve walking habits by increasing social~     support and decreasing perceived barriers, both of which are known to play a role in physical~     activity behaviors. In this Phase I research, surveys of potential end-users will determine~     interest in the app and focus groups will help shape a prototype of the app, which will be~     developed and tested to determine feasibility and functionality for a randomized Phase II~     intervention.~   "
38719|NCT03059888|"~     This pilot research study is being done to see if the drug abatacept (Orencia ®) will be~     helpful in treating patients with myasthenia gravis (MG) who do not respond satisfactorily to~     other drugs that are used to suppress the immune system. Abatacept has been successful in~     treating experimental MG in laboratory animals, and this study is to determine its~     effectiveness in patients with MG.~   "
38720|NCT03059875|"~     The risk of diagnosis of cancer increases with age, especially breast cancer in elderly~     women. Elderly population is heterogeneous, regarding physiological reserves, comorbidities,~     disability and geriatric conditions. Comprehensive geriatric assessment (CGA) is a~     multidimensional approach to determine geriatric profile, in helping the therapeutic~     strategy. In-patients with diagnosis of cancer are screened with the FOG (oncology geriatric~     filter), to identify vulnerable subjects who may benefit from CGA. This scale of ten~     questions includes geriatric domains such as functional status, nutrition, mood, cognitive~     abilities and comorbidities. In elderly patients with breast cancer considered as fit~     (FOG=0), CGA is not necessary before adjuvant treatment. In vulnerable patients (FOG ≤ 1 and~     < 3), CGA is held in routine to discuss the adjuvant therapy feasibility. Patients with FOG ≥~     4 underwent CGA if palliative care is considered.~      Patients in the intermediate group (FOG 1-3) are randomized to determine time of CGA, before~     or after surgery.~      The aims of this study are to assess the outcomes regarding the time of CGA, in elderly~     female patients with breast cancer management, and to define the optimal place of CGA in care~     pathway.~   "
38721|NCT03059862|"~     This study evaluates the role of dietary L-tryptophan, an essential amino acid, in the~     activation of a specific cellular component: the aryl hydrocarbon receptor.~   "
38722|NCT03059849|"~     To examine whether a temporary three month increase in adalimumab dosing will prevent relapse~     in patients with inflammatory bowel disease in clinical remission who have elevated~     calprotectin.~   "
38723|NCT03059836|"~     This study will examine the influence of n3 PUFA supplementation on the rate of muscle~     atrophy in women undergoing 2 weeks of unilateral limb immobilization. Assessments in~     skeletal muscle strength and skeletal muscle volume will also me made before, after and in~     recovery from immobilization.~   "
41258|NCT03026686|"~     This is a retrospective chart review of women who labored and delivered in a single health~     care center. From that large group the investigators will evaluate women who were re-admitted~     in the post partum period for a hypertensive disorder. The study will also look at~     Controls, a group of women with similar risk factors but did not require readmission.~   "
38730|NCT03059732|"~     The differences in patient's clinicopathological characteristic between high and low~     prevalence of gastric cancer region should be further examined to elucidate factors that~     associate with poor survival rate of patients with gastric cancer. Therefore, this study~     aimed to evaluate characteristics of patients with gastric adenocarcinoma and factors~     associated with different outcome in Thailand and Japan to find a clue to improve patients'~     survival in low prevalence country such as Thailand.~      This is a retrospective cohort study. It was conducted at King Chulalongkorn Memorial~     Hospital, Thailand and Osaka Medical Center for Cancer and Cardiovascular Disease, Japan.~     Eligible cases were selected by using standardized search protocols: formal computer searches~     of all patients seen at out-patient clinic and/or hospitalized for gastric cancer between~     2010 and 2014.Two physicians, who were informed the definition of each variable, individually~     reviewed chart of patients.~   "
38731|NCT03059719|"~     This is a randomized, opened, positive drug-controlled (Exenatide, Byetta), sequential~     parallel group, multiple dose study to evaluate the safety, tolerability, pharmacokinetics~     and pharmacodynamics of twelve once-weekly subcutaneous doses of PB-119 to subjects with type~     2 diabetes mellitus (T2DM).~   "
38732|NCT03059706|"~     This study evaluates the efficacy of intra-articular administration of RegenoGel-OSP™ to~     treat pain and the safety and efficacy on subject's activity and quality of life following~     arthroscopic surgery due to degenerative or traumatic meniscal tear. adult subjects will be~     randomized and sequentially assigned to RegenoGel-OSP™ or placebo treatment on a 1:1 basis.~   "
38733|NCT03059693|"~     Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by a disturbance~     of epidermal-barrier function that results in intensely pruritic subacute and chronic~     eczematous plaques. As the most common cause of chronic inflammatory skin diseases, AD is a~     major cause of morbidity and suffering, affecting upto 30% of children, and increasing in~     prevalence throughout the world. It is estimated that the direct cost of AD in the US alone~     ranged from $0.9 billion to $3.8 billion every year. The current therapy of AD is reactive,~     where the flares are treated through symptomatic management with topical corticosteroids and~     calcineurin inhibitors. Given that these medications have long-term side-effects, and given~     the chronically relapsing immunopathogenic nature of AD, there is an imperative need for~     safer anti-inflammatory medications. Haus Bioceuticals (Haus) has developed a topical~     treatment for eczema/atopic dermatitis (AD) denoted HAT1, and have demonstrated that HAT1 is~     safe and profoundly effective in the treatment of AD, controlling signs and symptoms in 85%~     of patients with AD. This study is aimed to further evaluate the potential of developing HAT1~     as an integral part of AD therapy.~   "
38734|NCT03059680|"~     This study evaluates the safety and physiologic effects of increasing dietary potassium~     intake in individuals with heart failure.~   "
38735|NCT03059667|"~     Chemotherapy still constitutes the backbone of small-cell lung cancer (SCLC) therapy,~     particularly in the extensive disease (ED) stage (ED-SCLC). Despite the fact that a~     substantial complete response rate could be achieved in SCLC patients receiving etoposide -~     cisplatin doublet, cure remains the exception. Overall survival in patients receiving this~     combination is 10 months and progression free survival 6.3 months. At time of progression two~     options are hitherto accepted: reinduction of carboplatin - etoposide doublet or, for~     patients unfit for reinduction, topotecan single-drug regimen. However, in both clinical~     cases, median survival hardly achieves 33 weeks. Consistent data using anti - PDL1~     (Programmed death-ligand 1) or anti PD1 (programmed cell death 1) antibodies suggest that~     they are active as single drug regimens in many malignant diseases. Taking into account the~     rich tumor infiltrating lymphocyte in pathological specimens of SCLC, we can hypothesize that~     experimental use of ATEZOLIZUMAB (MPDL3280A) in patients is ethical pending that it~     demonstrates activity in the second line setting.~   "
38736|NCT03059654|"~     To evaluate the usefulness of ultrasound-guided percutaneous dilatation tracheostomy PCT in~     obese patients.~   "
38737|NCT03059641|"~     To evaluate the concordance of sensitizing mutations detected between paired plasma and~     tissue samples; the correlation between the clonal status of sensitizing mutations and~     targeted therapy response; and the prognostic impact of the relative abundance of sensitizing~     / resistance mutations.~   "
38738|NCT03059628|"~     BTI (Brief Therapeutic Intervention) motivates individuals admitted to ED (Emergency~     Department) for acute intoxication to take actions to prevent further alcohol-related issues.~     The present project aims at underpinning this intervention by actively involving patients in~     the monitoring of their alcohol-related risk following discharge. While several web-based~     preventive interventions towards alcohol already exist, the repeated delivering of PNF~     (Personalized Normative Feedback) using mobile technology after a BTI constitutes a novel~     approach to reduce alcohol-related harms. Investigators propose to test the effect of a~     mobile PNF following a BTI delivered by a psychologist during an ED visit for alcohol~     intoxication. The mobile PNF will be additionally delivered once a month in the 6-months~     period after discharge, and once every two months in the following 6-month period, via a~     smartphone application connected to a central server. The study will include 18-26 years old~     adults, as this population includes most active students and is often lost to follow-up after~     ED visits; and aims the reduction of heavy drinking occasions, as this issue account for most~     of alcohol-related ED visits in this population.~   "
38739|NCT03059615|"~     This is a Phase 2a, Open-label, one arm study in which the eligible patients will be treated~     with IV Nerofe, three times a week in 28 days cycles (up to 12 cycles).~      Evaluation will include safety procedures, blood level of study drug in certain time points,~     immune system response and tests checking the mechanism of the drug action.~   "
38740|NCT03059602|"~     The purpose of this study is to describe the biopsychosocial impact of caregivers in patients~     undergoing total knee arthroplasty, total hip arthroplasty, and cervical/thoracic/lumbar~     spine surgery.Defining such impacts may offer opportunities to enhance caregiver capability~     to provide care following surgery on a loved one.~   "
38741|NCT03059589|"~     The purpose of this patient registry is to demonstrate safety and efficacy of food oral~     immunotherapy in food allergic patients. Factors that lead to adverse reactions will be~     identified. The frequency of rescue epinephrine use will be recorded.~   "
41259|NCT03026673|"~     Chart review of women who have delivered an infant in a single health care system to~     determine if NSAID use increases blood pressures in the postpartum period.~   "
38742|NCT03059576|"~     The purpose of this investigation is to assess the role of the genetic and environmental~     factor on circadian system, in free living conditions by the use of a female twin population.~     With the results from this study, the investigators expect to advance in the understanding of~     the role of the endogenicity of the circadian system variables such as temperature, activity,~     sleep and timing of food intake as the main cause of the coincidence of the rhythms. However,~     the investigators expected that some parameters are still dependent on environment to a~     relevant extent and, hence, amenable to change through external interventions.~   "
38743|NCT03059563|"~     While deficits in dopamine D2-type receptor availability have been linked to substance use~     disorders, higher availability associates with better behavioral treatment outcomes for~     stimulant dependence and resilience to addiction. Varenicline has been shown to upregulate~     D2-type receptors in drug-naive rats, and could be a useful therapeutic approach for the~     treatment of addictive disorders in humans.~      The purpose of the study is to assess the relationship between varenicline, dopamine~     signaling (specifically, D2-type receptor availability), functional connectivity within~     corticostriatal circuitry, genetic markers associated with smoking and methamphetamine abuse,~     and measures of cognitive performance.~      The investigators hypothesize that varenicline but not placebo will upregulate (increase)~     striatal dopamine D2-type receptor availability and improve cognition, and that the change in~     availability will correlate with the change in cognition. The investigators also hypothesize~     that varenicline but not placebo treatment will repair dysregulated connectivity between the~     striatum and prefrontal cortex observed in methamphetamine users, and will correlate with the~     change in cognition.~      The study design consists of two positron emission tomography (PET) and functional magnetic~     resonance imaging (fMRI) scans to measure dopamine D2-type receptor availability and~     functional connectivity between the prefrontal cortex and striatum, two cognitive testing~     sessions including a battery of tests assessing working memory, declarative memory, sustained~     attention, inhibitory control, and reward-based decision making. Following eligibility~     screening, thirty six methamphetamine users will be enrolled and tested/scanned once prior to~     initiation of varenicline or placebo treatment and then again after completion of treatment.~   "
38744|NCT03059550|"~     Because prevalence of glucose metabolism disorders is high in patients with coronary disease,~     the Oral Glucose Tolerance Test (OGTT) is recommended in all patients without diabetes after~     an acute coronary syndrome (ACS). However, there are some concerns about its performance in~     clinical practice. The aim of our study was to evaluate, after an acute coronary syndrome~     (ACS), the feasibility and efficacy of the OGTT in a cardiac rehabilitation (CR) center in~     comparison with its real application in the whole French population.~   "
38745|NCT03059537|"~     This study aims to validate a possible diagnostic test for bile acid diarrhoea prospectively~     compared to the SeHCAT scintigraphy. Fasting participants are given a standard meal and 1,250~     mg chenodeoxycholic acid. The investigators measure fasting FGF19, bile acids species~     including 7-alpha-CHO and serial blood samples after the stimulation.~   "
38746|NCT03059524|"~     The objectives are to:~        1. validate a panel of tissue-specific miRNAs that are differentially expressed in the~          plasma of patients with and without multiple organ failure.~        2. investigate the dysregulation of circulating miRNA panel and their prognostic and~          predictive values in clinical outcomes in identifying patients at high risk for~          mortality and multiple organ failure.~      This trial involves peripheral blood sampling from subjects at their earliest presentation~     and remaining stays in the hospitalization in the emergency department. The investigators~     will develop panels of miRNAs that are specific indicator of early onset of major organ~     failures, and correlate clinical outcomes with these miRNAs.~   "
38747|NCT03059511|"~     To assess pharmacokinetics parameters for nalbuphine after intravenous and intranasal~     administration in infants. Also effect on pain score: Neonatal Infant Pain Score (NIPS) and~     safety will be evaluated with summary of Adverse Events.~      Inclusion criteria are: Infants 29 days-3 months, minimum Body weight 3.0 kg, Indications:~     septical work up.~      Exclusion criteria are: Infants who were born prematurely (before 37 weeks gestation), known~     kidney or liver disease, known chronic illness.~   "
38748|NCT03059498|"~     The purpose of this study is to determine peak plasma bupivacaine concentrations in a similar~     fashion for PECS I/II blocks. The investigators hypothesis is that the mean peak plasma~     levels for patients undergoing PECS I/II blocks will be less than the levels reported to~     cause early neurotoxicity of [2.2 (0.9) micrograms/ml]6 in patients receiving intravenous~     bupivacaine infusions.~   "
38749|NCT03059485|"~     This research study is studying a cancer vaccine called Dendritic Cell/AML Fusion vaccine~     (DC/AML vaccine) as a possible treatment for Acute Myelogenous Leukemia (AML).~      The interventions involved in this study are:~      -Dendritic Cell/AML Fusion vaccine (DC/AML vaccine)~   "
38750|NCT03059472|"~     Strong Hearts for New York is a research study which aims to reduce cardiovascular disease~     (CVD), improve quality of life, and reduce CVD related health care costs in rural~     communities. Our aim is to better understand how changes in lifestyle can affect the health~     of rural women and others in their communities.~   "
38761|NCT03059329|"~     The objective of this study is to identify the following in adult epilepsy participants with~     partial-onset seizures (with or without secondary generalized seizures) or primary~     generalized Tonic-clonic seizures who receive long-term treatment with Fycompa:~        1. unknown adverse drug reactions (ADRs);~        2. occurrence of ADRs;~        3. factors that are likely to affect safety and efficacy;~        4. occurrence of dizziness, balance disorders, ataxia, muscle relaxation-related adverse~          events, and falls as priority investigation items;~        5. occurrence of psychiatric adverse events as priority investigation items (eg,~          aggression).~   "
38762|NCT03059316|"~     Controlled hypotension has been used as a mean of reducing intraoperative blood loss and~     better visualization of the surgical field in nasal surgeries. Perfusion index has been~     considered a useful tool for monitoring changes in peripheral perfusion using Masimo set and~     serum lactate for central perfusion. Many medications were used to induce hypotension. In~     this study we will compare the effects of tridil and labetalol on the perfusion.~   "
41260|NCT03026660|"~     The purpose of this study is to determine the effects of Moringa Oleifera on the structure~     and function of bone in post-menopausal women ingesting 1000 mg of Moringa Oleifera daily for~     12 weeks.~   "
38751|NCT03059459|"~     Several studies have demonstrated the association between atmospheric pollution and chronic~     respiratory diseases. The magnitude of this association and its dependence of local factors~     are still unknown in Argentina, particularly for obstructive lung diseases like asthma and~     chronic obstructive pulmonary disease (COPD). The objective of this study is to assess the~     effect of atmospheric pollution due to particulate matter (PM) on asthma and COPD~     exacerbations in adults. A prospective cohort study will be carried out in patients attending~     the pulmonary service of a public hospital located in San Nicolas, Buenos Aires province,~     Argentina. Patients will be followed for 12 months after recruitment. The outcome variables~     will be the frequency of hospitalizations or emergency department consults for asthma or COPD~     exacerbations and related conditions, and the impact of COPD on a person's life as measured~     by the COPD assessment test (CAT) questionnaire. The exposure will be the pollution level in~     the particular address, measuring PM10 concentrations with portable equipment. Other~     variables as air temperature, humidity, and individual patient risk factors will be~     considered as potential confounders or effect modifiers. The associations will be estimated~     through regression models, i.e. logistic and Poisson regressions and recurrent event survival~     analysis. The results of this study should provide elements to estimate the risk of chronic~     respiratory diseases associated with atmospheric pollution, and to evaluate strategies for~     risk assessment in the local community.~   "
38752|NCT03059446|"~     This rollover study will provide open-label treatment with cenicriviroc and will assess the~     long-term safety of continued treatment with cenicriviroc in participants who participated in~     the CENTAUR study 652-2-203 [NCT02217475].~   "
38753|NCT03059433|"~     Advancement via Individual Determination (AVID) is a college preparatory program that~     provides a unique opportunity to determine whether schools can reduce substance use by~     re-grouping at-risk students with high-performing students, while providing additional~     academic and emotional support. Operating in 4,837 K-12th grade schools worldwide and across~     45 US states, this widely-disseminated program targets students from groups traditionally~     underrepresented in higher education who are currently performing in the academic middle~     (i.e., a 2.0-3.5 grade point average). AVID removes these students from typical classrooms~     and exposes them to a peer network in which academic performance and positive social norms~     are valued. In addition, by strengthening the student/teacher relationship, AVID expands~     students' networks of supportive adults. For low-income minority students in the academic~     middle, relatively small investments in prevention might significantly impact their academic~     and health trajectories. AVID capitalizes on a moment when social networks are in flux—the~     transition to high school—to shift these students' trajectories.~      This study is a longitudinal, randomized pilot evaluation of AVID among low-income minority~     adolescents entering high school, comparing academic performance and drug use, as well as~     other risky behaviors, over 3 years. Although social networks are hypothesized to have a~     strong influence on behavior, few studies have tried to re-wire networks to change behaviors.~     This study will provide a clearer understanding of whether schools can intentionally shape~     networks and whether these changes can reduce substance use. This study will also explore~     important mechanistic questions about whether and how AVID changes peer networks and~     relationships with teachers, whether those changes lead to improvements in academic and~     behavioral outcomes and, if so, what the relative importance of peer versus adult network~     changes are.~   "
38754|NCT03059420|"~     The purpose of this study is to identify genes associated with impaired development and~     function of the cranial nerves and brainstem, which may result in misalignment of the eyes~     (strabismus) and related conditions.~   "
38755|NCT03059407|"~     Young children with known or suspected heart disease frequently have difficulty cooperating~     with a clinically ordered echocardiogram. Current distraction techniques vary in efficacy.~     There have been no studies examining the use of animal assisted therapy to improve~     echocardiogram quality and completeness, as well as the patient/parent experience.~      Hypotheses:~        1. The presence and interaction of therapy dogs with young children undergoing~          echocardiography in a clinical setting will result in more complete and higher quality~          echocardiograms compared to standard distraction techniques.~        2. Parents will report higher visit satisfaction scores and greater exam comfort for their~          children for echocardiograms performed with the aid of canine assisted therapy compared~          to use of standard distraction techniques.~      Study Activities and Population Group:~      Pilot Phase: Introduction of trained therapy dogs (approved by the Pets at Duke Therapy~     Program) for 10 echocardiograms to observe canine-patient interactions and determine best~     practices for inclusion of dog/handler team into the echocardiogram protocol.~      Study Phase: 150 subjects ages will be selected from all children ages 1 to 5 years~     presenting for clinically ordered echocardiograms during the study time period. Subjects will~     be assigned into one of three groups: 1) Canine assisted therapy only; 2) Canine assisted~     therapy plus standard distraction techniques; and 3) Standard distraction techniques only.~     Echocardiography reviewers will be blinded to subject study group and will assign quality and~     completeness score based on validated criteria. Parental satisfaction will be assessed using~     validated survey tools.~      Data analysis and risk/safety issues:~      All subjects will be assigned a random subject ID, with the only link to PHI stored in a Duke~     Redcap database. Statistical testing will be performed with the assistance of Tracy Spears~     (biostatistician in DCRI) who has assisted with development of testing tools. There are no~     physical risks associated with the echocardiogram portion of the study, and very minimal~     risks with the therapy dog portion of the study. Please see Pets at Duke policy included in~     study documents. There is a potential loss of confidentiality, although the only link between~     subject ID and PHI will be stored in a Duke Recap database.~   "
38756|NCT03059394|"~     The aim of the study is to evaluate the psychometric properties (content and construct~     validity, reliability, measurements error, as well as possible floor and ceiling effects) of~     both the assessments MMT8 and the myositis activity profile in patients with IM.~   "
38757|NCT03059381|"~     The objective of this study is to identify the following in adolescent epilepsy participants~     with partial-onset seizures (with or without secondary generalized seizures) or primary~     generalized Tonic-clonic seizures who receive long-term treatment with Fycompa:~        1. unknown adverse drug reactions (ADRs);~        2. occurrence of ADRs;~        3. factors that are likely to affect safety and efficacy;~        4. occurrence of dizziness, balance disorders, ataxia, muscle relaxation-related adverse~          events, and falls as priority investigation items;~        5. occurrence of psychiatric adverse events as priority investigation items (eg,~          aggression).~   "
38758|NCT03059368|"~     To construct a self-designed plate fixation device for posterior cruciate ligament~     reconstruction, aim to verify its advantages on anatomical knee stability, so as to achieve~     fracture healing and keep tension after posterior cruciate ligament reconstruction.~   "
38759|NCT03059355|"~     This study is to compare the safety and efficacy of UCMSCs and BMMSCs administered~     intravenously in patients to evaluate cytokine suppression in patients with chronic~     inflammation. Cells administered via intravenous infusion (IV) and will be tested in 37~     patients in two phases (Pilot and Randomized).~   "
38760|NCT03059342|"~     Purpose: The aim of this study is to assess the short- and midterm evolution of self-care and~     functional mobility after multilevel surgery in children and adolescents with spastic~     diplegic cerebral palsy and to identify which factors could have an impact on these outcomes.~      Methods: Thirty-four participants were included. All participants will be evaluated before~     surgery, at 9 weeks, 6,12,18, 24, 36 and 60 months. Self-care was assessed with the Pediatric~     Evaluation of Disability Inventory-NL (PEDI-NL). The Mobility Questionnaire47 (MobQues47) and~     Functional Mobility Scale (FMS) were used to measure functional mobility. Interactions~     between CP, personal and environmental characteristics and evolution in time were assessed.~   "
38803|NCT03058783|"~     Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic~     Dermatitis in Pediatric and Adult Subjects~   "
38763|NCT03059303|"~     The purpose of this study is to assess the relative bioavailability of single-dose Simeprevir~     (SMV), Odalasvir (ODV), and AL-335 when administered as a fixed-dose combination (FDC)~     compared with the single agents when administered together, and to assess the effect of~     multiple-dose lansoprazole and omeprazole on the single-dose pharmacokinetics (PK) of SMV,~     ODV, and AL-335 when administered as an FDC.~   "
38764|NCT03059290|"~     this prospective in vivo randomized clinical is to evaluate the post operative pain~     (incidence ,degree and duration) with multiple full rotation file (protaper next ®) and~     single full rotation file (Neolix®) in treating maxillary and mandibular anterior and~     premolar with chronic pulpitis .Together with our aim from this trial ; we are trying to~     provide an evidence for the dentists in order to provide the best quality service with the~     least expenses and thus gaining the patients' trust and saving time, money and effort.~   "
38765|NCT03059277|"~     The purpose of this study is to determine the efficacy of intravitreal aflibercept injections~     administered in a treat and extend fashion in eyes that have persistent center involved~     diabetic macular edema following at least 4 intravitreal injections of 0.3 mg ranibizumab~     over 24 weeks.~   "
38766|NCT03059264|"~     Congenital Myotonic Dystrophy (CDM) is a multi-systemic, dominantly inherited disorder caused~     by a trinucleotide repeat expansion (CTGn) in the DMPK gene. CDM occurs when the CTGn~     increases between the adult myotonic dystrophy type-1 (DM1) parent and the child. Children~     with CDM present at birth with respiratory insufficiency, talipes equinovarus, feeding~     difficulties and hypotonia. There is a 30% mortality rate in the first year of life. As~     children grow, they are at risk for intellectual impairment, autistic features,~     gastrointestinal symptoms, and motor delay.~      The investigators will enroll children with CDM between ages 0-15 with visits at baseline and~     one year to evaluate appropriate physical functional outcomes, cognitive function and quality~     of life over time. Functional outcome measures will be correlated with potential biomarkers~     in the children. Completion of these specific aims will extend the understanding of disease~     progression in CDM and will provide the requisite information for successful therapeutic~     trials in children with DM.~   "
38767|NCT03059251|"~     This observational study aims to study the effectiveness and safety of Obinutuzumab in common~     clinical practice settings in Argentina. The study population comprises all patients with~     chronic lymphocytic leukemia (CLL) that have received the indication for treatment with~     Obinutuzumab as per routine clinical practice.~   "
38768|NCT03059238|"~     This phase III, randomized, prospective clinical study, aiming to compare the analgesic~     effects of celecoxib, parecoxib, and oxycodone in patients with inoperable hepatic carcinoma~     undergoing TACE procedure in postoperative pain control.~   "
38769|NCT03059225|"~     The refinement of repetitive transcranial magnetic stimulation (rTMS) has highlighted its~     merit in terms of learning programs as a treatment for aftereffect augmentation.~     Nevertheless, the efficacy of synchronous rTMS protocol integrated with computer-integrated~     speech training is not well understood. It is also not clear regarding the efficacy of~     compound bi-hemispheric stimulation protocol. The aim of the study is to investigate language~     response to these new strategies and to determine the longevity of the therapeutic outcome.~     Advanced MR neuroimaging techniques, such as fMRI and DTI, are powerful tools to evaluate the~     concomitant nervous changes after rTMS treatment on aphasic patients. The knowledge from fMRI~     and DTI microstructural evolution provides insight into underlined mechanism operating the~     language improvement.~   "
38770|NCT03059212|"~     Ten sessions of repetitive transcranial magnetic stimulation yield ability to upregulate the~     function of primary motor cortex and prefrontal cortex that play key roles in motor and~     frontal memory processing is hypothesized in this study.~   "
38771|NCT03059199|"~     The purpose of this research is to implement and evaluate the feasibility of the HAT- TRICK~     Program, a gender- sensitive intervention program targeting physical activity, healthy eating~     and connectedness in men living in the Okanagan Region, BC.~   "
38772|NCT03059186|"~     The primary aim of the proposed research is to investigate the extent to which a one-week~     online gratitude intervention can improve levels of wellbeing in individuals living with~     Inflammatory Bowel Disease (IBD). A secondary aim was to investigate the extent to which~     dispositional gratitude influences levels of coping and wellbeing and to what extent this~     mediates the effect of the intervention. Participants with IBD will be randomized to either~     treatment or control group. Participants will complete measures pre- and post- intervention,~     and follow-up (eight weeks) measuring: gratitude (state and trait), illness severity, mood,~     stress and coping.~   "
38773|NCT03059173|"~     The main objective will be to check if MyoInositol (MYO) reduces the total resistance rate to~     Clomiphene Citrate (CC). For this, our study will be controlled, randomized and double~     blinded. It will include patients with PCOS (polycystic ovary syndrome, defined by the~     Rotterdam criteria) who wish to become pregnant and are eligible to simple ovulation~     induction by CC. Half of them will receive MYO + folic acid (FA) in addition to the CC, while~     the other half will receive a placebo containing only FA in addition to the CC. The MYO~     supplementation will be initiated at least one month before taking CC and will be continued~     throughout this treatment until pregnancy or before switching to another type of treatment~     for ovulation induction if no pregnancy is obtained after 6 ovulatory cycles.~   "
38774|NCT03059160|"~     This is a single-center, exploratory, open-label study in 10 girls diagnosed with Rett~     Syndrome. The study will consist of the following 4 parts: Screening/Baseline run-in,~     Titration/Dose-Setting, Treatment, and Washout/Follow-up.~   "
38775|NCT03059147|"~     2.1 Primary Objectives~        1. To determine the maximum tolerated dose (MTD) or maximum recommended dose of SF1126 in~          adult patients with advanced (unresectable or metastatic) HCC and Child-Pugh A or~          Child-Pugh B7 cirrhosis.~        2. To determine the recommended phase II dose of SF1126 in patients with advanced~          (unresectable or metastatic) HCC and Child-Pugh A or Child-Pugh B7 cirrhosis.~      2.2 Secondary Objectives~        1. To describe the safety and tolerability of SF1126 in adult patients with underlying~          liver disease by ongoing evaluation of adverse events.~        2. To determine pharmacokinetics in HCC patients.~        3. To assess the effect of SF1126 on progression-free survival and overall survival.~      2.3 Endpoints~      Primary Endpoint~      The primary endpoint is the rate of dose limiting toxicities (DLTs) at within 56 days of~     starting treatment, and the maximum tolerated dose or maximum recommended dose of SF1126.~   "
38776|NCT03059134|"~     This clinical trial compared the therapeutic effects and adverse events (AEs) in overactive~     bladder (OAB) patients receiving different combination of mirabegron and antimuscarinics.~      Methods: This is a prospective randomized study. OAB patients received mirabegron 25 mg (M25)~     daily for one month (1M) and then were randomized as group 1: to continue M25, group 2: to~     mirabegron 50 mg, group 3: to shift to solifenacin 5 mg (S5) and group 4: to combine M25 and~     S5 for further 2 months (totally 3 months, 3M). Efficacy and AEs were evaluated. At the end~     of 3M, the preferred option for future treatment was investigated.~   "
38777|NCT03059121|"~     In this observational study, the investigators will examine the changes in body composition~     in HIV-infected subjects before and after initiation of HIV treatment, and look at the~     correlations with changes in cardiometabolic indices such as endothelial function and~     coronary calcium scoring.~   "
38778|NCT03059108|"~     The trial is designed as a consecutive enrollment prospective one-center study. A minimum of~     30 patients will be included in the study. At implant installation, the implant will be~     randomized to one of the groups (Control: conventional loading, 8 weeks; Test: early loading,~     4 weeks). Samples of peri-implant crevicular fluid (PICF) and intrasulcular plaque will be~     collected at -14, 0 (Baseline: prosthesis delivery), 7 days and 1, 3, 6, 12 months.~     Prosthesis will be fabricated and delivered as usual, i.e., approximately two weeks after the~     impressions are taken.~   "
38779|NCT03059095|"~     The study rationale is to analyze the extent to which adult U.S. or non U.S. veterans or~     active duty military personnel who participate in the Yoga for Men (YfM) online Yoga and~     meditation classes report changes in symptoms of psychological trauma, depression, anxiety,~     stress, sleep quality, and pain. The serial measurement of symptom status over a 12-month~     period will provide information on the trajectory of change in symptom status, as well as~     insight into the extent to which this program may be an effective modality for veterans and~     service members who are experiencing symptoms of psychological trauma, depression, anxiety,~     stress, sleep quality, and pain. The purpose of this study is to evaluate whether the~     existing YfM online program is helpful to study qualifying veterans with symptoms of PTSD and~     related conditions.~   "
38780|NCT03059082|"~     Excessive alcohol consumption is common in patients admitted to the intensive care unit~     (ICU). Among patients who survive an ICU admission, excessive alcohol consumption is~     associated with a higher risk of being admitted the hospital. In this study, the~     Investigators will compare an intervention designed to address excessive drinking in ICU~     survivors to usual care. This intervention combines motivational interviewing (MI) and shared~     decision making (SDM). MI and SDM share several core components including the development of~     a therapeutic alliance and promotion of autonomy. MI can be employed in the context of~     motivating a patient to change their drinking. Once this decision has been made, SDM can be~     employed to help a patient decide amongst multiple reasonable treatment options. The~     Investigators long-term goal is to test whether MI-SDM is better than usual care and whether~     multiple sessions of MI-SDM are better than a single session. This pilot clinical trial will~     demonstrate the feasibility of conducting a larger efficacy study to test these hypotheses.~   "
38781|NCT03059069|"~     The aim of this study is to investigate the effect of Gliatamin (chonline alphoscerate) on~     depressive mood in type 2 diabetes patients and demonstrate the impact of improved depressive~     mood could be influence the patient's quality of life and glycemic control.~   "
38782|NCT03059056|"~     Project PI (Principal Investigator): Dr Bassam Mahfouz Ayoub, Ph.D., Lecturer of~     Pharmaceutical Chemistry, The British University in Egypt.~      Study Design The proposed study will consider the pharmacokinetic evaluation of empagliflozin~     after administration to Egyptian volunteers and the results will be compared with the other~     reported ethnic populations. The FDA recognizes that standard methods of defining racial~     subgroups are necessary to compare results across pharmacokinetic studies, and to assess~     potential subgroup differences. The design of the study is open labeled, randomized, one~     treatment, one period, single dose pharmacokinetic study.~   "
38783|NCT03059043|"~     This study evaluates the safety and efficacy of a viscoelastic-free method for Implantable~     Collamer Lens(ICL) implantation to treat high myopia. Subjects were randomly assigned either~     to the new method group or to the control group which uses the standard method for~     implantation. The post-operative data are collected for analysis.~   "
38784|NCT03059030|"~     Evaluate the safety and efficacy of Yttrium-90 (90Y) radioembolization for the management of~     thrombocytopenia.~   "
38785|NCT03059017|"~     The relative bioavailability of different salbutamol sulphate inhaler formulations will be~     studied in healthy male subjects according to the ethical regulations of World Medical~     Association Declaration of Helsinki (1996) after the approval of the ethical committee,~     Faculty of Pharmacy, The British University in Egypt.~   "
38786|NCT03059004|"~     Knee osteoarthritis is a disabling problem affecting over 15 million adults in the United~     States. Many people who have knee arthritis also experience painful meniscal tears. There are~     a number of different treatments that can be used to manage meniscal tears in the presence of~     knee arthritis. Treatments include surgically removing the damaged part of the meniscus;~     strengthening exercises to improve pain and function; manual therapy including massage and~     mobilization; acupuncture; and others. The combination of surgery and exercise therapy was~     long thought to be the best treatment. However, recent studies have shown that surgery~     followed by physical therapy is no more effective than physical therapy by itself.~      While physical therapy alone has been shown to result in similar pain relief as arthroscopic~     surgery, researchers have not yet done studies to determine what type of physical therapy is~     best for people with knee arthritis and meniscal tears. In the TeMPO Trial, we will be~     comparing 4 different, non-operative physical therapy regimens in order to gain a better~     understanding of how physical therapy works and what regimen will best reduce pain and~     improve function in persons with meniscal tear and osteoarthritis. The four arms in this~     randomized trial will contain different combinations of therapeutic treatments including~     in-clinic therapist-supervised exercise, in-clinic topical therapies, and exercises to be~     completed at home. Subjects in three of the arms will also receive motivational SMS (text)~     messages intended to improve adherence to the home exercise regimen.~      TeMPO is designed as a randomized controlled trial. Participants will be assigned randomly to~     one of the four arms. All arms include therapies that have been previously shown to work in~     clinical settings. One arm also contains some placebo treatments. The placebo treatments will~     help us to understand what aspects of physical therapy actually make people feel better.~      Our hypothesis is that subjects in the arm that includes in-clinic physical therapy and a~     home exercise regimen will experience more pain relief than subjects in each of the other~     arms. Also, we expect that subjects in the arm that receives the home exercise regimen and~     SMS messages will experience more pain relief than subjects in the arm that receives home~     exercise without the SMS messages.~   "
38804|NCT03058770|"~     A prospective, randomized double-blind clinical trial will be conducted to determine the~     effect of a sensorimotor retraining program on the sensory and functional recovery of the~     paretic lower limb of subjects with chronic sequelae from stroke.~   "
38805|NCT03058757|"~     The aim of this study is to evaluate the effectiveness and safety of neoadjuvant intravesical~     mitomycin-C instillation in non-muscle invasive bladder cancer patients~   "
38787|NCT03058991|"~     The purpose of the current proposal is to investigate the extent to which interventions~     designed to improve cognitive (working memory) and emotional (distress tolerance) regulatory~     processes enhance the effectiveness of standard no-smoking informational interventions.~     Emotional and cognitive dysregulation increases the likelihood of smoking and makes it~     particularly challenging to benefit from standard interventions. Working memory and~     associated deficits make it more difficult for individuals to utilize information from~     interventions, make judicious decisions regarding the cost and benefits of smoking, and to~     resist targeted advertising. In addition, disruptions in emotion regulatory capacities~     increase the probability of using cigarettes as a coping mechanism to self-regulate negative~     affect and stress. Individuals with affective disturbances smoke at higher rates and have~     more difficulties quitting, and are more likely to smoke as a way to reduce negative affect.~     The goal of the current project is to generate new insights and new approaches to smoking~     prevention among low-SES youth by investigating (1) the influence of known SES-related~     deficits in working memory and affect regulation on proximal measures of smoking risk, and~     (2) the potential for targeted interventions to reverse these risks. Specifically, the~     investigators examine the influence of working memory training and distress tolerance~     (mindfulness) interventions on cognitive/affective targets placing individuals at risk for~     smoking initiation and maintenance.~      The specific aims of this study are therefore to investigate:~        1. The feasibility and acceptability of school- and community-based brief interventions~          targeting working memory and distress tolerance in a diverse sample of low SES~          adolescents.~        2. The effects of working memory and distress tolerance interventions, relative to a~          standard informational intervention alone, on specific cognitive-affective targets—delay~          discounting and distress tolerance--relevant to cigarette smoking initiation and~          maintenance.~        3. The impact of cognitive /affective target activation on proximal measures of smoking~          risk/behavior and related health outcomes following intervention.~   "
38788|NCT03058978|"~     The study will evaluate how the ovaries may be functioning while using the the~     Implanon®/Nexplanon® during the three years beyond the FDA approved duration. Ovarian~     function will be assessed with weekly serum progesterone levels. Participants will undergo~     weekly venipuncture for a total of four draws. Participants will be followed for 30 days.~   "
38789|NCT03058965|"~     The overall goal of this imaging trial is to evaluate [18F]MNI-958, a tau targeted PET~     radioligand, in individuals with Alzheimer's disease (AD), Progressive Supranuclear Palsy~     (PSP), and healthy volunteers (HV).~   "
38790|NCT03058952|"~     This study is a randomized clinical trial measuring outcomes up to 6-months~     post-intervention. The objective of this study is to evaluate outcomes of two different group~     interventions for Veterans with Chronic Multisymptom Illness (CMI). The interventions to be~     compared are Mindfulness-Based Stress Reduction and an adapted version of the Chronic Disease~     Self-Management Program (aCDSMP) for Veterans experiencing symptoms of Chronic Multi-Symptom~     Illness (CMI) - musculoskeletal pain, fatigue, and cognitive failures - especially those who~     were deployed to Gulf War I. Hypothesis One (re: Outcomes): Participants randomized to the~     adapted Chronic Disease Self-Management Program (aCDSMP) will derive benefit for the primary~     outcomes, but with smaller effects than the participants randomized to Mindfulness-Based~     Stress Reduction (MBSR). The investigators hypothesize that Veterans randomized to MBSR will~     report greater reductions in each of the three primary outcome measures (pain, fatigue, and~     cognitive failures) at 6-month follow-up as compared to aCDSMP. Hypothesis Two (re:~     Acceptability): MBSR will be an acceptable and satisfactory program for Veterans with CMI, as~     measured by attendance rates, a self-report measure of satisfaction, and qualitative~     interviews. The investigators hypothesize that Veterans with CMI randomized to MBSR will~     report greater satisfaction with care than their peers randomized to aCDSMP.~   "
38791|NCT03058939|"~     This is a two-stage phase II study with a single arm design. It will be conducted in women~     with breast cancer with stages IIA to IIIC (defined by AJCC 2009 classification) of all~     histological subtypes. All patients will receive 16 doses of paclitaxel; three breast~     ultrasound tests and tumor pathologic response evaluation will be used to assess the response~     to treatment.~   "
38792|NCT03058926|"~     The data management systems, auditing, and monitoring effort are supported by the MD Anderson~     Cancer Center Clinical Research Support Center (CRSC). The The Coordination and Data~     Management Center (CDMC) will provide high quality, efficient and consistent leadership and~     services in all aspects of data quality and assurance; data harmonization and management;~     while providing assistance to the projects in disseminating and interpreting those data. The~     CDMC PI will provide statistical (study design, analysis plans, data analysis, and~     interpretation), data management, and data monitoring/auditing (data quality assurance and~     harmonization) expertise for the proposed projects. The Cancer Center will have access to~     identifiable data from studies; analysis of this data will not be conducted under this~     protocol. Any future analysis conducted on data or specimens as part of CPDPC protocols will~     be conducted under a separate IRB approved data or lab protocol.~      The CDMC will leverage existing support, infrastructure, and resources from the Data~     Management and Coordinating Center for the Global Cancer Early Detection and the clinical~     expertise of the Division of Pathology/Lab Medicine at MDACC.~   "
38793|NCT03058913|"~     This registry is created under the sponsorship of the Outpatient Endovascular and~     Interventional Society (OEIS) to monitor the clinical course and treatment outcomes of~     patients undergoing office-based endovascular procedures.~   "
38794|NCT03058900|"~     An abnormal intestinal microbiota may be the mediator of the common inflammatory pathways~     seen in psoriatic arthritis. This study will explore clinical aspects associated with~     modifying the intestinal microbiota by infusing fecal donor microbiota into the small~     intestine of psoriatic arthritis patients with a minimum of three swollen joints despite at~     least three months of methotrexate treatment.~   "
38795|NCT03058887|"~     Systemic sclerosis (SSc) is a multisystem connective tissue disease characterised by vascular~     abnormalities and fibrosis, including those of the skin and can be categorised as either~     Limited cutaneous scleroderma or Diffuse cutaneous scleroderma. It is estimated that more~     than 90% of patients with SSc experience Raynaud's phenomenon (RP) at regular intervals~     during the course of their disease. Approximately 50% of patients with SSc develop severe~     digital ischaemia and/or ulceration which seems to be painful, difficult to heal, susceptible~     to infections and heavily influences quality of life and increases SSc-related disability.~      Medical treatment is commonly used as an effective first line approach in the NHS policy when~     uncontrolled RP attacks emerge. However, considering the short-term side effects (oedema,~     headaches, heart palpitations, dizziness and constipation) but also the long-term side~     effects of nifedipine (heart dysfunction and increased cardiovascular risk) as well as the~     financial cost of this approach, alternative approaches with less side effects and less cost~     implications are warranted.~      An alternative approach would be to implement a programme of therapeutic exercise that would~     be suitable for this patient group. To the investigators knowledge the efficacy of exercise~     on microcirculation in RP has not been previously examined. In this regard, high intensity~     interval training (HIIT) has come to prominence over the last years for its effectiveness in~     inducing greater improvements in vascular function than moderate intensity continuous~     training. Due to the variation in HIIT protocols evidence is limited to support which~     protocol is the most effective in SSc patients. Moreover, it should be noted that the chief~     aim of the research project is to encourage long-term adherence to physical activity and~     rehabilitation programmes in these patients which might be beneficial for the vascular~     function. A short HIIT protocol (30seconds/passive recovery) may elicit more favourable~     patient reported satisfaction /enjoyment levels compared to other longer exercise duration~     protocols. A short HIIT protocol (30seconds/passive recovery) has demonstrated to be well~     tolerated, preferred protocol with a low perception of effort, patient comfort and with a~     longer time spent at high percentage of V̇O2peak than a longer HIIT protocol with active~     recovery phases in chronic heart failure patients. More recent evidence supports this notion;~     when enjoyment levels in an overweight/obese cohort were examined after a short HIIT~     protocol.~      Although it is known that HIIT is capable to improve vascular function and potentially the~     microcirculatory parameters, evidence is scarce regarding the mode of exercise that will be~     more effective on digital microcirculation where the RP attacks are present in SSc patients.~     Assumptions could be made that utilising an upper-body exercise would potentially be more~     beneficial for the digital microcirculation rather than lower-body exercise where the working~     muscles promote the blood flow in the lower limbs. Hence, the differential effects that may~     occur by the upper- and lower-limb exercise on the digital microcirculation in SSc patients~     should be examined.~      Resistance training (RT) alone has shown significant improvements in the function of the~     vasculature; moreover, a combination of aerobic and RT have shown both in the past and~     recently important enhances in the vascular function and microcirculation. However, the~     limited number of studies have investigated the effects of RT on vasculature bespeaks a lack~     of concrete evidence. Moreover, to the investigators knowledge the effects of combined~     exercise (RT and aerobic exercise) utilising a HIIT protocol and RT on microcirculation has~     yet to be examined.~      Aims:~      The primary aim of the present study is to examine the feasibility of exercise in patients~     with Systemic Sclerosis experiencing Raynaud's Phenomenon.~   "
38796|NCT03058874|"~     The most common co-morbidity accompanying Chronic Kidney Disease (CKD) is hypertension, which~     appears in approximately 80% of all patients with renal dysfunction, whereas its prevalence~     in general population is remarkably lower appearing in approximately 30% of adults.Defining~     hypertension in ESRD patients under maintenance dialysis is a challenging procedure.~     Ambulatory blood pressure monitoring (ABPM) is considered the gold standard for the~     diagnosis of hypertension in hemodialysis patients over the last years. The major~     pathophysiologic mechanism underlying hypertension development in patients with ESRD under~     hemodialysis is water and sodium overload.~      Identifying an accurate and objective method of dry weight evaluation has been a matter of~     intensive nephrology research for more than two decades. Assessment of the water balance in~     hemodialysis patients on the basis of common clinical criteria (e.g. leg or face swelling or~     signs of lung congestion) is a subjective method with limited reliability, despite its~     widespread use. Recently, a novel technique has been developed to quantify water excess by~     conducting an ultrasound lung scan. Pilot studies have shown significant changes in lung~     water in hemodialysis patients according to body weight changes during interdialytic days and~     dialysis sessions. Moreover, results from previous studies indicate significant benefits from~     dry weight probing with regards to blood pressure (BP).~      The clinical application of a lung-ultrasound-based volume control strategy in hemodialysis~     patients is currently being tested by the randomized study entitled Lung water by ultrasound~     guided treatment to prevent death and cardiovascular complications in high risk end stage~     renal disease patients with cardiomyopathy (The LUST Study). This clinical trial aims at~     evaluating whether the use of the number of US-B lines could be used as a biomarker to guide~     a per-protocol intensification of ultrafiltration (UF) in order to reduce volume overload,~     improve cardiac function and prolong survival.~      Cardiovascular disease in patients with CKD is attributed to a spectrum of structural and~     functional alterations of the large and the small branches of the arterial tree. The most~     important process in patients with advanced CKD is that of arteriosclerosis, which is~     developed in parallel to atherosclerosis and is typically associated with impaired cushioning~     function of the aorta and the large conduit arteries. Accelerated arterial stiffening is~     involved in the development of isolated systolic hypertension, left ventricular hypertrophy~     (LVH) and congestive heart failure (CHF), which predispose to arrhythmias and sudden cardiac~     death. In the context of the phenomenon of aortic-to-brachial BP amplification, systolic BP~     (SBP) and pulse pressure (PP) conventionally measured at the level of brachial artery are~     higher than the relevant pressures in the ascending aorta. Due to extreme elevation of~     arterial stiffness, BP amplification is disturbed in patients with ESRD. Prospective cohort~     studies have demonstrated that elevated central PP, wave reflections and arterial stiffness,~     as well as, reduced PP amplification represent strong and independent predictors of all-cause~     and cardiovascular mortality in hemodialysis patients. On this basis, estimation of central~     BP indices appears as an important tool towards optimisation of cardiovascular risk~     stratification in ESRD as well as in other diseased populations.~      Until recently, available devices for ABPM evaluated BP levels only at the level of brachial~     artery. The newly developed Mobil-O-Graph NG (IEM, Stolberg, Germany) provides the ability to~     monitor central aortic pressure and indices of vascular resistance, such as wave reflections~     (augmentation index, AIx) and arterial stiffness (pulse wave velocity, PWV).This device has~     recently been validated in hemodialysis patients and showed comparable performance with the~     widely used tonometric SphygmoCor device (ArtCor, Sydney, Australia). Accumulated evidence~     over central BP and PWV in hemodialysis patients derives mostly from studies that included~     only static pre-dialysis and post-dialysis measurements. However, variations of BP levels~     during intra- and interdialytic intervals combined with the superiority of aortic BP~     measurements, as analysed above, indicate that ambulatory monitoring of central BP is the~     best available method.~      This study aims for the first time to evaluate the outcome of a treatment strategy for dry~     weight probing, based on volume overload quantification with lung ultrasound, on 24-hour~     aortic systolic BP and arterial stiffness in hemodialysis hypertensive patients.~      This is a Lust Sub-Study. Additional information can be found at: NCT02310061.~   "
38797|NCT03058861|"~     The project is designed to assess Adverse Childhood Experiences (ACEs) and test a parenting~     intervention in pediatric primary care.~   "
38798|NCT03058848|"~     To evaluate the acceptability, tolerance and effect on metabolic control of PKU Start, a new~     Phe free protein substitute for the dietary management of PKU in infants from birth.~   "
38799|NCT03058835|"~     The overall aim of this study is to assess attitudes toward PrEP, feasibility of Truvada PrEP~     procurement through the established access procedures, and adherence to Truvada PrEP among US~     women at risk for HIV acquisition.~   "
38800|NCT03058822|"~     A Phase 1, relative bioavailability study of BMS-931699 from prefilled syringe compared to~     drug in vial~   "
38801|NCT03058809|"~     This study will access the safety and efficacy of the Viatar™ Oncopheresis System to remove a~     meaningful quantity of circulating tumor cells from the blood of subjects' with breast, colon~     or prostate solid tumor cancers in a single treatment. CTC reduction will be measured as the~     change in circulating tumor cells as determined before and after treatment.~   "
38802|NCT03058796|"~     Determine if adding a video game component to an electrical stimulation therapy improves hand~     function in stroke patients~   "
38807|NCT03058731|"~     This is a prospective, case-matched, systematic follow up of up to 70 pre-existing patients~     whom underwent paraesophageal hernia repair between June 1, 2012 and September 30, 2016.~     Patients whom are willing to participate in the study will be asked to return for a one time~     follow up visit to reassess for hiatal hernia recurrence both symptomatically and~     radiologically to compare the efficacy of the use of MatriStem Surgical Matrix (ACell) mesh~     to other biologic meshes.~   "
38808|NCT03058718|"~     To explore effectiveness of procalcitonin-guided antibiotic therapy in acute exacerbations of~     bronchiectasis, and to explore the clinical value of procalcitonin in bronchiectasis.~   "
38809|NCT03058705|"~     The primary outcome of this study is to determine the minimal dwell time needed for adequate~     detection of hexaminolevinulate HCL avid tumors using protoporphyrin IX (PpIX) near infrared~     fluorescence (NIRF).~   "
38810|NCT03058692|"~     This is a Phase II randomized, double-blind, placebo-controlled trial in 120 males and~     non-pregnant females, 18 to 49 years old, inclusive, who are in good health and meet all~     eligibility criteria. This clinical trial will be conducted at 3 United States sites and is~     designed to assess the safety, reactogenicity, and immunogenicity of two priming doses of~     M-001 followed by a seasonal quadrivalent inactivated influenza vaccine (IIV4). The duration~     of this trial for each subject will be approximately 7 months. The entire study duration will~     be approximately 24 months. The primary objectives are: 1) To assess the safety as measured~     by vaccine related adverse events, reactogenicity, and laboratory adverse events of two doses~     of M-001 vaccine, each dose administered approximately 21 days apart; and 2) To assess the T~     cell responses to M-001 component peptides following two doses of M-001.~   "
38811|NCT03058679|"~     This protocol is designed to compare the effectiveness of two dietary interventions for~     patients with Crohn's disease (CD): the Specific Carbohydrate Diet (SCD) and a Mediterranean~     style diet (MSD) that has been demonstrated to have numerous other health benefits. The two~     diets will be compared in terms of their ability to resolve both the symptoms and bowel~     inflammation that characterize this debilitating disease.~   "
38812|NCT03058666|"~     Study to test the hypothesis that aerosolized Infasurf can decrease the need for intubation~     and instillation of liquid surfactant to the airway.~   "
38813|NCT03058653|"~     On the Intensive Care Unit doctors give a lot of fluid to patients in order to improve their~     blood pressure, amount of urine made or to let doctors stop drugs that are needed to keep~     blood pressure up. Doctors normally give patients 500ml of fluid over 25 minutes as standard,~     however it is very difficult to know if giving those fluids and how much fluid will help (it~     does in some but not others). If a person gets too much fluid this can also cause problems~     such as fluid in lungs, poor kidney function, or swelling in the limbs.~      The LidCo Rapid monitor lets the Intensive Care Unit (ICU) team know the amount of blood the~     heart pushes out with each beat (Stroke volume). It works by following the tracing off the~     arterial line (Blood pressure monitor) that has been inserted as part of the standard care of~     a patient on the ICU. It does not need any other invasive procedures or drug administration~     to work.~      This study is using this monitor to see if it can identify a method of improving the~     administration of intravenous fluids on the Intensive Care Unit. The study is looking to see~     if it can identify whether giving a small amount of fluid first identifies people who will~     benefit from more fluid and those that won't.~   "
38814|NCT03058640|"~     This randomized control study will investigate the health outcomes of adolescents with Down~     Syndrome who participate in a karate class as measured by ALPHA fitness testing and various~     PROMIS parent proxy questionnaires to assess participants mobility, physical activity, and~     overall affect.~   "
38815|NCT03058627|"~     The aim of this study is to evaluate the effect of routine FFR-guided complete~     revascularization with PCI compared to conservative management in patients with concomitant~     coronary artery disease who are undergoing TAVI.~   "
38816|NCT03058614|"~     This study will be a randomized controlled study comparing the use of two clinical management~     strategies in nephrostomy tube management following percutaneous nephrolithotomy (PCNL). The~     first strategy entails using contrast-enhanced ultrasound (CEUS) to evaluate the renal~     collecting system (1). This is a new imaging approach applying ultrasound machines with~     special software in combination with intraluminal ultrasound contrast agent (Lumason)~     injection, which is an FDA-approved ultrasound contrast agent (2). The second strategy is a~     nephrostomy tube capping trial combined with low dose non-contrast computed tomography (CT)~     scan, one of the most frequently utilized clinical management strategies currently used in~     clinical practice (3).~   "
38817|NCT03058601|"~     Cohort study using data from Clinical Practice Research Datalink (CPRD). The study cohort~     includes all patients who received at least one prescription for ticagrelor for the first~     time between December 2010 and March 2015, following ACS. Patient baseline characteristics~     will be described: (Age, Gender, Body Mass Index, Smoking status, Sociodemographic status),~     type of ACS and interventions, CV history and comorbidities, bleeding and respiratory~     history.~      The following outcomes will be examined: Incidence of vascular events (composite MI, Stroke,~     vascular death, specific vascular event and all cause death), incidence of bleeding and~     incidence of dysponea. Time to event for vascular events, bleeding and dyspnoea.~   "
38818|NCT03058588|"~     The aim of this study is to look for predisposing mutations in patients and relatives~     affected by AML and MDS with familial history of myeloid or, less frequently, lymphoid~     malignancies. Taking advantage of a next generation sequencing (NGS) platform, screening for~     known and unknown mutations potentially associated with the disease will be done. The~     screening will be performed on affected and unaffected family members, in order to outline~     new pedigrees that either validate previous findings or constitute novel discoveries.~   "
38819|NCT03058575|"~     This is a randomized, 2-period crossover study aimed at assessing the effect of taking a food~     supplement containing a blend of microbial accessible carbohydrates on the diversity of the~     gut microbiome. Impacts to the skin, scalp and oral microbiomes; blood inflammatory~     biomarkers; quality and quantity of sleep; gastrointestinal quality of life; bowel habits,~     and facial skin features will also be evaluated.~   "
41008|NCT03029962|"~     The purpose of this study is to finalize and rigorously evaluate Girl2Girl, a novel text~     messaging-based teenage pregnancy prevention (TPP) program designed specifically for LGB~     women ages 14-18 years, nation-wide. The guiding theoretical model is the~     Information-Motivation-Behavioral Skills (IMB) Model, which has been used extensively and is~     associated with increases in TPP behavior.~   "
38820|NCT03058562|"~     The study will investigate the effects and the safety of a single-dose of ABX-1431 HCl on~     tics and other symptoms of Tourette Syndrome.~      During part 1 (periods 1 and 2) each patient will receive study drug once and placebo once.~      Patients who complete part 1 with adequate clinical safety will be offered the option to~     participate in part 2 (periods 3 and 4) and again willl receive study drug once and placebo~     once where, in contrast to part 1, administration will take place with a standard high fat~     meal.~   "
38821|NCT03058549|"~     This study investigates the effectiveness of a program to strengthen the relationships of~     disadvantaged expectant couples, and to increase co-parenting, father involvement, and~     economic stability. Couples are randomly assigned to Family Expectations or a control group,~     and assessed at baseline and one year.~   "
38822|NCT03058536|"~     The aim of this randomized control trial is to determine wheter cervical pessary plus vaginal~     progesterone (400mg) reduce preterm birth less than 34 weeks of gestacion and improve~     perinatal outcome, among women presenting asyntomatic short cervix, in twin pregnancy.~   "
38823|NCT03058523|"~     Infants have an inborn preference for sweet and umami flavours and dislike sour and bitter,~     but there is evidence that sensory experiences beginning early in development can modify~     these preferences in favour ultimately of healthier food choices. Babies are first exposed to~     flavour in utero and then later through breast/formula milk. This can be manipulated to~     influence liking and consumption of individual foods with specific high-intensity flavours~     postnatally. There are no prospective studies evaluating the impact of increasing maternal~     fruit and vegetable intake during late pregnancy on a child's subsequent acceptance of fruit~     and vegetables, particularly those with a sour/bitter taste. The hypothesis is that an~     intervention to increase maternal intake of fruit and vegetables in late pregnancy will~     enhance fetal flavour exposure and make infants more likely to accept a wide variety of fruit~     and vegetables in childhood. Before testing this hypothesis, the investigators need to~     evaluate the general acceptance and taste profile of the fruit and vegetable formats that we~     intend to offer to pregnant women.~   "
38824|NCT03058510|"~     ORBID-OA is a single-center, observational study in 30 patients with stable coronary artery~     disease.~      The aim of the study is to analyze the outcomes of main vessel stenting on side branch in~     calcified bifurcation lesion and identify preprocedural predictors of side branch~     complication by utilizing two-dimensional (2D) and three-dimensional (3D) frequency domain~     optical coherence tomography (FD-OCT).~   "
38825|NCT03058497|"~     To ascertain whether home-based nocturnal TLA usage over a 12 month period can reduce~     exacerbations and improve asthma control and quality of life as compared to placebo, whilst~     being cost-effective and acceptable to adults with poorly-controlled, severe allergic asthma.~   "
38826|NCT03058484|"~     The investigators implemented and evaluated a pilot program in Shinyanga Region, Tanzania to~     bring prevention of HIV services to communities using community health workers (CHWs). The~     intervention aimed to integrate community-based maternal and child health services with HIV~     prevention, treatment, and care—bridging the gap between women and facility, and enhancing~     the potential benefits of Option B+. Option B+ is the current World Health Organization~     recommendation for prevention of mother-to-child transmission, but its success in sub-Saharan~     Africa may be threatened by overburdened clinics and staff. Consequently, paraprofessionals~     like CHWs can be key partners in the delivery and/or enhancement of health services in the~     community.~      The study focuses on whether this approach: increases retention in care; improves adherence~     to antiretrovirals (ARVs); or improves the number of women initiating antiretroviral therapy~     and the timing of initiation. Investigators hypothesize improvements along primary and~     secondary outcome indicators in the treatment group. This evaluation helps illuminate both~     the impact and feasibility of the intervention, and the role that CHWs may play in the~     elimination of mother-to-child transmission services.~   "
38827|NCT03058471|"~     This is a single center, prospective, randomized controlled open label trial with a one sided~     cross over design to compare the efficacy of initiating Methotrexate(Mtx) in early post~     Chikungunya induced arthritis (4-12 weeks after onset) with Non Steroidal Anti inflammatory~     Drugs(NSAID) alone.~   "
38828|NCT03058458|"~     The purpose of this study is to assess the safety, tolerability and pharmacokinetics of~     different single and repeat doses of PIN201104 in healthy volunteers and in patients with~     asthma.~   "
38829|NCT03058445|"~     Using an ultrasound echocardiography , we will measure the time to turbulance T2T from~     injecting saline into the central venous catheter CVC to the appeareance of turbulance on the~     screen using an MMode. The T2T will be compared with Chest X Ray CXR measured distance from~     the tip of the CVC to the carina.~      We are trying to evaluate if there is a significant correlation between the two measurements.~   "
38830|NCT03058432|"~     Concurrent Chemotherapy for Elderly Patients With Locoregionally Advanced Nasopharyngeal~     Carcinoma~   "
38831|NCT03058419|"~     The main purpose of this study is to determine the potential inhibitory/inducing effects of~     JNJ-54175446 after single and repeated dosing on the single-dose pharmacokinetics (PK) of a~     cocktail, containing selective probes of cytochrome P450 (CYP) enzymes (CYP3A4/A5, CYP2C9,~     CYP1A2, CYP2D6, CYP2B6, and CYP2C19) in healthy adult subjects.~   "
38832|NCT03058406|"~     The purpose of this study is to understand safety and efficacy in participants with soft~     tissue sarcomas.~   "
38833|NCT03058393|"~     The goal of this study is to analyze patient:provider communication surrounding the~     discussion of difficult clinical conversations such as knee replacement options. This study~     will also examine how using the teach-back communication technique can improve communication~     between patients and providers. Orthopedic residents, fellows, physician assistants, and~     attendings that agree to participate will be consented. Patients, who are likely to engage in~     a difficult clinical conversation, such as those who have a clinical indication for a Total~     Knee Replacement or a Partial Knee Replacement, will be recruited from participating~     providers clinical schedules. Patient:provider interactions will be recorded and then the~     providers will attend a 1 hour education lecture about how to use teach-back. After attending~     the lecture, additional patient:provider interactions will be recorded and analyzed via a~     qualitative approach. Additionally, providers will participate in a semi-structured interview~     to capture their perceptions of teach-back and what challenges and benefits they may derive~     from using it.~   "
38834|NCT03058380|"~     The primary objectives of this study are to apply best-practice stated-preference methods to~     quantify patient preferences for benefit-risk tradeoffs associated with arthroplasty~     treatment options for end-stage osteoarthritis of the knee. Duke will develop and administer~     stated-preference surveys to adult patients (Ages 40-80) with knee pain to collect preference~     data, estimate the relative importance of treatment features and outcomes, and estimate~     maximum acceptable risks for given benefits and minimum acceptable benefits for given harms.~     This study proposal describes plans for the patient stated-preference survey.~   "
38835|NCT03058367|"~     This study is to evaluate the benefit and tolerability of two dosages of IQP-AE-103 (990mg~     and 1980mg daily) in reducing body weight in overweight and moderately obese subjects~   "
38836|NCT03058354|"~     Propofol is a commonly used anaesthetic with rapid recovery and less side effects and total~     intravenous anaesthesia (TIVA) with propofol is a common technique now. The reduction on~     certain serum pro- inflammatory cytokines may lead to more smooth post- surgical recovery.~      Recent case report proved the analgesic effect of propofol infusion. However other animal and~     clinical studies showed controversial result.~      The aim of this retrospective study is to investigate the postoperative analgesic effects and~     side effects of intraoperative TIVA with propofol in patient undergoing surgery at Queen Mary~     Hospital, Hong Kong between 2014 to 2016.~   "
38837|NCT03058341|"~     Propofol is one of the most commonly used intravenous anaesthetic drugs both for induction~     and maintenance of general anaesthesia. Some of the advantages of total intravenous~     anaesthesia (TIVA) with propofol include reduced nausea and vomiting, reduced atmospheric~     pollution, better wake up profile and a more favourable intracranial physiology. However, the~     need for a reliable intravenous access, specialized pumps, pain on injection and potential~     concerns regarding awareness are some reasons that preclude more common use.~      Postoperative dental pain produces an inflammatory pain model. Since propofol has~     anti-inflammatory effects, it may have significant analgesic effects in patients undergoing~     dental surgery. To the best of our knowledge, there are no randomized controlled trials~     comparing the effects of TIVA propofol and inhalational anaesthetic on postoperative dental~     pain. The aim of this study is to investigate the effect of TIVA propofol on postoperative~     pain scores, analgesic consumption, and adverse effects in patients undergoing dental~     surgery. This will help determine whether propofol may be a useful analgesic adjunct in~     dental surgery.~   "
38838|NCT03058328|"~     The purpose of this study is to describe numerical and functional changes in the white blood~     cell efter surgical trauma. Further, observed immune cell changes correlate to heart rate~     variability and cognitive function will be assessed.~   "
38839|NCT03058315|"~     The main purpose of the study is to investigate the importance of patients' beliefs regarding~     staying active despite low back pain, among patients referred from general practice to~     secondary care treatment in Denmark. It is hypothesised that patients believing that staying~     active will help them recover will have higher odds of a 30%-improvement in The Roland Morris~     Disability score after 52 weeks compared to patients disagreeing that staying active will~     lead to better recovery.~   "
38840|NCT03058302|"~     This project aims to contribute to the development of a community mental health care system~     while directly serving the conflict affected population in east Ukraine. This project is~     being supported by USAID's Victims of Torture Fund. In the Spring of 2015, the Johns Hopkins~     University (JHU) Applied Mental Health Research Group (AMHR) was invited to make a site visit~     to Ukraine with USAID to make an initial assessment of current mental health problems,~     service capacities, and treatment need. AMHR and USAID were requested by community-based~     partners to provide training and support in evidence based trauma treatment for people~     affected by war and displacement. Extensive conflict within the borders of Ukraine is a new~     experience for most Ukrainians, and local psychologists and psychotherapists were not~     prepared for wide-spread need or trained in appropriate methods of treatment for affected~     populations. JHU and USAID began activities in Ukraine in June 2015 and have identified the~     counseling intervention, Common Elements Treatment Approach (CETA), as appropriate and~     relevant for this context. Community providers from the three trial sites (Kyiv, Kharkiv, and~     Zaporizhia) have been trained in CETA as counselors and local supervisors.~      An ongoing training and supervision model (Apprenticeship Model) is being implemented in the~     three study sites. These three sites contain significant numbers of military veterans~     (demobilized soldiers from the ongoing conflict) and internally displaced persons (IDPs).~     Adult IDPs and Veterans from the three study sites will be recruited and screened to identify~     those with elevated depression and/or posttraumatic stress symptoms and impaired functioning.~     This study will be conducted as a 3-armed randomized controlled trial. This study will test~     to see if both the long and a short version of CETA are effective compared to a wait-control~     condition.~   "
38841|NCT03058289|"~     This study evaluates the intratumoral administration of escalating doses of a novel,~     experimental drug, INT230-6. The study is being conducted in patients with several types of~     refractory cancers including those at the surface of the skin (melanoma, head and neck,~     lymphoma, breast) and tumors within the body such (pancreatic, colon, liver, lung, etc.).~     Sponsor also plans to test INT230-6 in combination with anti-PD-1 antibodies.~   "
38842|NCT03058276|"~     This experimental research studies the efficacy of two different treatments for inhibitory~     control improvement in alcohol-dependent individuals, one consisting of Retrieval-Extinction~     Learning ( alcohol AAT Task) and the other consisting in rTMS of the right dorsolateral~     prefrontal cortex.~   "
38843|NCT03058263|"~     This study aimed to evaluate the effect of Neostigmine partial dose towards neuromuscular~     blockade of rocuronium~   "
38844|NCT03058250|"~     This is a prospective randomized controlled trial looking at the utility of intraoperative~     transesophageal echocardiography (TEE) on clinical outcomes after radical cystectomy.~     Patients in the control group will have standard of care, patients in the TEE group will have~     standard of care and TEE monitoring throughout. Intraoperative and postoperative variables,~     such time to extubation, postoperative cardiac and pulmonary complications, intraoperative~     fluid and vasopressor use will be assessed.~   "
38845|NCT03058237|"~     Part 1~        -  To evaluate the pharmacokinetic (PK) profile of Arbaclofen Placarbil (AP) and R-baclofen~          following dosing of Arbaclofen Placarbil Modified Release (MR) Prototype A Tablet and~          Arbaclofen Placarbil MR Prototype B Tablet in healthy subjects~        -  To determine the relative bioavailability of AP and R-baclofen following dosing of~          Arbaclofen Placarbil MR Prototype A Tablet and Arbaclofen Placarbil MR Prototype B~          Tablet compared to the reference Arbaclofen Placarbil Sustained Release (SR) Tablets~          (low dose)~        -  To determine the relative bioavailability and PK of AP and R-baclofen following dosing~          of the selected MR prototype formulation(s) in the presence of beverage~        -  To provide additional information on the safety and tolerability of single doses of AP~      Part 2~        -  To evaluate the PK profile of AP and R-baclofen following dosing of Arbaclofen Placarbil~          MR Prototype Tablets in healthy subjects~        -  To determine the relative bioavailability and PK of AP and R-baclofen following dosing~          of Arbaclofen Placarbil MR Prototype Tablets compared to the reference Arbaclofen~          Placarbil Immediate Release (IR) Capsule~        -  To provide additional information on the safety and tolerability of single doses of AP~        -  To determine the relative bioavailability and PK of AP and R-baclofen following dosing~          of a selected MR prototype formulation in the fed state (optional)~        -  To explore a possible in vitro in vivo correlation/relationship (IVIVC/IVIVR) for the~          Arbaclofen Placarbil MR Prototype Tablet Formulations~      Part 3~        -  To determine the relative bioavailability of the selected Arbaclofen Placarbil MR~          Prototype Tablet in the presence of either beverage or food and/or~        -  To evaluate the PK profile (dose proportionality) of AP and R-baclofen following dosing~          of the selected Arbaclofen Placarbil MR Prototype A + B Tablet at different dose levels~          in healthy subjects~        -  To provide additional information on the safety and tolerability of single doses of AP~   "
38846|NCT03058224|"~     This is a randomized, double-blind, placebo-controlled exploratory trial to investigate~     efficacy and safety of food supplement IGN-ES001 in patients with chronic widespread pain~     (CWP) with or without fibromyalgia (FM).~   "
38847|NCT03058211|"~     Hypothesis: The novo cardiovascular events (CVE)in patients with severe community-acquired~     pneumonia (CAP) are frequent (17%) and could be associated with both direct pneumococcal~     myocardial invasion, toxin delivery (pneumolysin) or different biomarkers (histones,~     NETs(neutrophil extracellular traps), IL (Interleukin)-1b,h-Fabp (heart-Fatty acid bindding~     protein) ).The CVE frequency and its impact on outcome in patients without prior heart~     disease (CP) has not been studied.~      Objectives:1) To determine the incidence of myocardian injury (MI) and CVE in patients with~     CAP without CP evaluated by non-invasive techniques (Echocardiograph and MRI) and biomarkers~     levels (Tn-I (Troponin I), h-Fabp, NT-proBNP (N-terminal pro-brain natriuretic peptide)~     histones, NETs, IL 1b); 2) To assess if DMA and CVE are related to the etiology and their~     impact on outcome , 3) To investigate the presence of myocardial scarring by MRI and its~     relationship with etiology and MI, and 4) To identify prognostic factors of DMA and CVE to~     determine level of risk.~   "
38848|NCT03058198|"~     The epidermal growth factor receptor variant Ⅲ(EGFR vⅢ) is commonly detected in high-grade~     gliomas, which is also an important epitope in EGFR-targeted therapies and correlated to poor~     prognosis. However, detection of this mutant usually needs resected tumor samples. For biopsy~     samples, test results may not represent the EGFR vⅢ status of the whole tumor tissues because~     of the heterogeneity of tumor. It is also not applicable for patients who are not suitable~     for surgical procedure due to the tumor location or patients' general conditions. Because of~     the importance of the epidermal growth factor receptor (EGFR) signal pathway in oncogenesis,~     maintenance, and progression of high grade glioma, there has been an intense effort to~     develop noninvasive molecular imaging approach for the selection and monitoring of~     EGFR-targeted therapies.~      Based on investigators' previous study, investigators plan to perform PET scanning on the~     participants with high grade gliomas after the injection of the second generation of EGFR~     tracer ,89Zr-ABT806, which can be specifically binded to EGFR vⅢ . After fusing the PET and~     MRI images, investigators precisely obtain the tissue from thehot-spot on the PET image~     through multimodal-neuronavigation-guided tumor biopsy. EGFRvⅢ status will be detected by~     molecular methods to analyze the correlation with the 89Zr-ABT806 PET image qualitatively and~     quantitatively. Investigators' final goal is to detect EGFR vⅢ by noninvasive molecular~     imaging procedure for the clinical outcome prediction and the selection of EGFR-targeted~     therapies.~   "
38849|NCT03058185|"~     Laminopathies and emerinopathies are complex group of rare disorders due to mutations in~     A-type lamins (LMNA) and Emerin (EMD) genes. Among them, disorders affecting skeletal and/or~     cardiac muscles are the most frequent clinical manifestations, with cardiac disease being a~     major cause of death. Remarkable progress has been made in the description of the clinical~     and genetic spectrum of these diseases since the 1990's. Until now, precise~     phenotype/genotype relations remain elusive. As for several other neuromuscular disorders,~     apart from symptomatic treatments, there is currently no specific treatment to prevent or~     slow down the progression of the disease. The OPALE registry is a multicentre web-based~     registry dedicated to laminopathy and emerinopathy French patients. OPALE has been approved~     by ethical and regulatory authorities. Its main inclusion criteria is the presence of a~     proven pathogenic LMNA and/or EMD gene mutation.~      The OPALE objectives are to provide a tool allowing detailed capture of patient genetic,~     neurological, cardiological, endocrinological and respiratory assessments, in order to allow~     i) precise disease natural history, ii) evaluation of different disease complication~     frequency and iii) identification of prognosis factors.~   "
38850|NCT03058172|"~     The aim of this research project is to better understand the reciprocal influence of visual~     and olfactory systems on cerebral activity evoked by odors and visual stimuli. Given the~     importance of olfacto-visual learning in expert situations, the degree of expertise in~     olfaction will also be considered. In addition, the investigators will try to better~     understand the differences between expert and non-expert populations in olfaction through~     different levels of approach: sensory, genetic and cerebral. To achieve this, the~     investigators will use psychophysical tests, genetic analyzes and a non-invasive technique,~     functional magnetic resonance imaging (fMRI) to measure the brain activity of human subjects~     - novices or experts in olfaction - in response to different visual and olfactory stimuli.~   "
38851|NCT03058159|"~     The aim of the study is to investigate the functional connectivity between the brain regions~     of the default mode network before and after a 40 min nap slot in the afternoon. The~     hypothesis is that connectivity between brain regions will be decreased after the nap as~     compared to before the nap.~   "
38852|NCT03058146|"~     Physical activity interventions with older adults can improve brain health; however most~     interventions have been performed in gym-like settings that reach a small sector of the~     senior population. Since not everyone can access a gym, it is important to study whether~     brisk walking in real world environments can also help brain health. This study will use~     mobile health devices to help older adults independently walk for brain health, thus~     representing a critical step towards the dissemination of physical activity intervention~     programs aimed at preserving cognitive function in aging.~   "
38853|NCT03058133|"~     Bayesian models of perception represent a promising approach to describe information~     processing by the brain. Predictive coding hypothesizes a process in which top-down~     expectations are continuously compared across multiple hierarchical levels with bottom-up~     sensory inputs and the differences or error signals are propagated in a bottom-up direction.~     The investigators hypothesize that strong expectations, are best investigated in expert~     processes such as face and voice recognition in humans. Individuals in complex social systems~     need to extract socially relevant information in a fast and efficient manner; hence, the~     majority of humans constitute face, voice and gender experts. Nevertheless, linking such~     combined abilities to brain activity with regards to the predictive coding hypothesis has not~     been attempted.Our results suggest asymmetric contributions of visual and auditory signals to~     the gender classification task. This sensitive psychophysical procedure is implemented in a~     decoding approach using fMRI and multi-voxel pattern analysis (MVPA). The investigators plan~     to test whether cortical areas implicated in processing auditory and visual gender signals~     show similar asymmetries.~   "
38854|NCT03058120|"~     This was a prospective randomized, controlled trial designed to quantify the reduction in~     cost and length of stay of early discharge of emergency department patients evaluated for~     acute myocardial infarction, who are deemed to be low risk based on a modified HEART score (a~     score that incorporates troponin biomarker, ecg, patient characteristics, and physician~     clinical judgment).~   "
38855|NCT03058107|"~     Cancer is a worldwide spread disease with high prevalence and incidence, often of poor~     prognosis because it is typically diagnosed in an advanced stage. Another reason for this~     prognosis is the presence of malnutrition, on the one hand because of a diminished intake~     (due to anorexia), and on the other hand because of tumor-induced hypercatabolism. The result~     is a pathological state of the body called cachexia, generally defined as a weight loss >~     5% during the last 6 months before diagnosis. It had already been demonstrated that correct~     nutrition in such patients can limit morbidity, while promoting progression-free survival as~     well as well-being. The pilot study, previously performed by the investigators, was the first~     to suggest that Nutrition Therapy, based on the ESPEN guidelines and resting energy~     expenditure measured by indirect calorimetry, can promote overall survival. The aim of this~     project is to validate these preliminary results in a larger RCT (randomized controlled~     double-blind trial), to promote Nutrition Therapy as a novel modality in its own right in the~     treatment of cancer, rather than being merely supportive.~   "
38856|NCT03058094|"~     A Phase III, Open-Label, Randomized Multicenter Study to Compare AC0010 and~     Pemetrexed/Cisplatin in Patients With Advanced NSCLC Who Have Progressed Following Prior EGFR~     TKI.~   "
38857|NCT03058081|"~     Early pulmonary rehabilitation is recommended after an episode of severe exacerbation of~     chronic obstructive pulmonary disease (COPD). However, its implementation is challenging~     particularly as regard exercise training. High flow ventilation in reducing work of breathing~     and dyspnea may improve exercise tolerance. The aim of this study is to carry out the acute~     effect of high flow nasal cannula on exercise endurance in post-exacerbation copd patients~   "
38858|NCT03058068|"~     A Safety Run-In will be followed by a Double-Blinded Randomized Phase. All subjects shall~     meet the inclusion/exclusion criteria, and will be evaluated prior to the scheduled infusion~     to establish baseline.~      There will be 3 subjects in the safety run-in phase and 15 subjects in the double-blinded~     phase.~   "
38859|NCT03058055|"~     The BEST study will investigate the feasibility of cognitive interventions in a randomized,~     placebo-controlled, clinical trial. The investigators will recruit 45 cognitively normal~     subjects and engage them in one of three cohorts over an 8 week period, including active~     reading vs. origami study arms and a placebo group without structured cognitive intervention.~   "
38860|NCT03058042|"~     The objective of this study is to compare the effect of outpatient pelvic floor muscle~     training versus home pelvic floor muscle training in the treatment of stress urinary~     incontinence. The hypothesis of this study is that home pelvic floor muscle training is as~     effective as outpatient pelvic floor muscle training for the treatment of stress urinary~     incontinence.~   "
38861|NCT03058029|"~     A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Assessing the Effect of~     Gelesis200 on Body Weight in Overweight and Obese Subjects without or with Type 2 Diabetes~   "
38862|NCT03058016|"~     This clinical study is designed to evaluate the providing of a computational prediction~     engine for optimization of personalized nutrition~      Personalized recommendations for effective diet, lifestyle and activities based on the~     patient's parameters measurements and reactions will be provided on a bi-weekly basis, all~     Lab tests and dietician control will be performed twice a month.~   "
38863|NCT03058003|"~     To investigate the use of balance as a screening tool for Central Sensitization, a condition~     of the nervous system that is associated with the development and maintenance of chronic~     pain. This is done by comparing the scores of a gold standard screening tool (the Central~     Sensitization Inventory) with balance data.~   "
38864|NCT03057990|"~     This is a phase I study designed to assess the maximum tolerated dose (MTD) of pyrimethamine~     and provide the recommended Phase 2 dose (RP2D) for the treatment of intermediate/high-risk~     MDS that is refractory to or relapsed after treatment with azanucleosides.~   "
38865|NCT03057977|"~     The aim of the study is to investigate the safety and efficacy of empagliflozin versus~     placebo on top of guideline-directed medical therapy in patients with heart failure with~     reduced ejection fraction.~   "
38866|NCT03057964|"~     This is a two part study to evaluate the efficacy of early combined PDL (pulsed dye laser)~     and fractional photothermolysis in the cosmetic improvement of post surgical scars.All~     subjects will be offered at the time of the dermatologic procedure, an option to treat the~     post surgical scars with early combined PDL and fractional photothermolysis.~      Part A is a non-randomized study design and subjects will have the choice of whether or not~     they will receive treatment. In part B, subjects will be randomized in a 2:1 treatment vs.~     control design.~      The experimental group will have a total of 6 visits: 1 standard of care suture removal~     visit, 3 treatment visits and 2 follow up visits. The control group will have 3 visits: 1~     standard of care suture removal visit and 2 follow up visits.~      Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion~     criteria will be considered for enrollment.~      This study is a pilot study designed to determine feasibility of this procedure.~   "
38867|NCT03057951|"~     The aim of the study is to evaluate efficacy and safety of empagliflozin versus placebo on~     top of guideline-directed medical therapy in patients with heart failure with preserved~     ejection fraction~   "
38868|NCT03057938|"~     Phase II, open-label clinical trial with a medicinal product. A total of 30 subjects will be~     included in the study.~      All participants will receive a single intravenous dose of 300 MBq of FBB. A 20-minute PET~     image should be acquired starting at approximately 90 minutes after intravenous injection of~     FBB.~      The present proposal aims are: to assess safety of a single dose of FBB followed by PET scan~     in individuals with subjective cognitive decline (SCD), to determine the number of SCD~     subjects with positive visual FBB-PET scan, to determine the number of SCD subjects with~     positive standardized uptake value ratios (SUVRs) of FBB-PET scan and to explore the cortical~     pattern of amyloid deposition in SCD subjects.~   "
38869|NCT03057925|"~     Percutaneous microwave ablation(MWA) was reported as an effective modality for the management~     of thyroid nodules(TNs). This study aims to validate MWA as a feasible approach for patients~     with TNs for whom surgery is contraindicated or refused. Two groups of subjects with TNs(one~     group to treat with MWA and the other group to receive regular ultrasonic follow-up without~     any treatment) will be evaluated in term of TN volume, ultrasonic image and clinical~     symptoms.~   "
38870|NCT03057912|"~     This is an open-label and triple cohort study of the safety and efficacy of TALEN and~     CRISPR/Cas9 to possibly treat HPV Persistency and human cervical intraepithelial~     neoplasiaⅠwithout invasion.~   "
38871|NCT03057899|"~     Objective: The aim of this study was to investigate the efficacy and safety of a mixed~     extract of fenugreek seed and Lespedeza cuneata (TFG) for the treatment of testosterone~     deficiency syndrome (TDS).~      Design: Patients were instructed to take a placebo capsule or 200 mg TFG capsule twice per~     day for 8 weeks.~      Outcome measures: The primary efficacy variable was the change from baseline in the Aging~     Males' Symptoms scale (AMS), as well as levels of serum total testosterone and free~     testosterone. Secondary efficacy measurements included changes from baseline in the number of~     'yes' answers on the Androgen Deficiency in the Aging Male questionnaire (ADAM), levels of~     serum total cholesterol, HDL-C, LDL-C, triglyceride, perceived stress scale (PSS-10), all~     domain scores of the International Index of Erectile Function (IIEF), as well as changes in~     body composition.~   "
38872|NCT03057886|"~     This study compares the use of the SPOT ON thermometer with the oral, esophageal in~     participants submitted to general and the oral thermometer to spinal anesthesia, from the pre~     op, intra and post op stages, evaluating the accuracy of this new monitor against the already~     consecrated one by literature. The Investigators will analyze in three different types of~     anesthesia (general, spinal and pediatric population).~   "
38873|NCT03057873|"~     The objective of this study is to investigate the effect of a high protein, high fiber~     dietary supplement on weight and fat loss in healthy overweight adults. Half of participants~     will receive a high protein, high fiber supplement twice a day for 12 weeks, and half of the~     subjects will receive a placebo (that contains the same amount of calories as the supplement)~     twice a day for 12 weeks.~   "
38874|NCT03057860|"~     Atopic dermatitis (AD) constitutes significant burden to patients, families, and healthcare~     systems.~      About 60% of all patients with AD are adults. Patients with moderate-to-severe AD cannot be~     sufficiently controlled with topical treatments alone and require intermittent or continuous~     treatment with systemic immunomodulating agents or UV-therapy.~      Systematic reviews indicate that although 12 different interventions for moderate-to-severe~     AD have been studied in clinical trials, strong recommendations are only possible for the~     short-term use of cyclosporin A (CSA).~      Methodological limitations in the majority of trials such as the choice of non-validated~     outcomes and outcomes that are not most relevant to patients prevent evidence-based clinical~     decision making.~      Pharmaceutical treatment of patients suffering from AD is diverse and frequently not in line~     with the current guidelines (for example S2-guideline in Germany).~      Systemic anti-inflammatory and immune-modulatory therapies include several conventional~     immunosuppressive agents such as glucocorticosteroids, CSA, methotrexate (MTX), azathioprine~     (AZA), interferon-gamma (IFN-γ), intravenous immunoglobulins (IVIG), and mycophenolate~     mofetil (MMF) or mycophenolate acid. Dupilumab is the first biologic treatment for AD with~     very promising results in clinical trials. Other biologic treatments are currently being~     developed for the treatment of moderate-to-severe AD.~      Large head-to-head trials are missing so that long-term effectiveness of systemic~     interventions for moderate-to-severe AD is speculative.~      In this situation, clinical registries can provide valuable information for evidence-based~     clinical decision making.~      Objectives: Establishment of a national evidence-based clinical registry and research network~     with the following objectives:~        1. Characterization of medical care and pharmaceutical therapies of adults suffering from~          moderate-to-severe AD. The perspective of the patient (utility, treatment goals, quality~          of life, and treatment satisfaction), sequence of treatments, and change of treatments~          will be a primary focus.~        2. Investigation of comparative effectiveness, tolerability and safety of systemic~          therapies for moderate-to-severe AD.~        3. Development of a platform for further investigations, such as pragmatic clinical trials,~          epidemiologic studies, outcomes research, immunologic and molecular research (given~          approval of responsible ethics commission).~   "
38875|NCT03057847|"~     Incorporating HCV treatment into opioid maintenance treatment program clinical protocols is~     an innovative health care delivery model that has been associated with improved HCV treatment~     uptake in non-pregnant, drug-using populations. This medical home approach would combine~     HCV and opioid maintenance treatment into one treatment regimen and incorporate the expertise~     of obstetricians, hepatologists, substance abuse treatment providers and pediatricians into~     one comprehensive clinical care model. The purpose of this study is to evaluate the~     feasibility/acceptability of a combined, peripartum HCV and opioid maintenance treatment~     program on adherence to HCV treatment regimens and evaluate the rate of IVDU recidivism, HCV~     reinfection and health related QOL in women with OUD during the first postpartum year.~      The protocol involves three separate study phases. All 3 study phases will occur with support~     from hepatology providers at Magee-Womens Hospital. Phase 1 involves screening, enrollment~     and a baseline assessment of liver function, HCV infection (genotype, viral load) and blood~     and urine studies in HCV-infected patients during pregnancy. In Phase 2, subjects will~     undergo 12 weeks of sofosbuvir/velpatasvir therapy initiated at 2 weeks postpartum.~     Feasibility/acceptability and adherence to sofosbuvir/velpatasvir will be assessed at 4, 8~     and 12 weeks of therapy. In Phase 3, subjects will continue to be followed for 15 months~     after treatment completion. Treatment effectiveness and SVR will be evaluated at 3 months and~     rates of IVDU recidivism, HCV reinfection and patient centered outcomes such as health~     related quality of life (QOL) will be assessed at 6, 9 and 12 months following treatment~     completion.~   "
38876|NCT03057834|"~     Investigators plan a prospective cohort study with an adaptive design based on physical~     function status. The design will involve tracking the number of women recruited with physical~     function impairment and those without any functional impairment. Investigators aim to recruit~     similar numbers of women in each group. If investigators find unequal numbers, they will~     adapt recruit strategies based on a woman's functional status.~   "
38877|NCT03057821|"~     The investigator's plan to determine whether pre-operative skin preparation with hydrogen~     peroxide alters rates of P acnes culture positivity. They hypothesize that pre-operative skin~     preparation with hydrogen peroxide will reduce rates of P acnes culture positivity.~   "
38878|NCT03057808|"~     The purpose of this study is to enroll approximately 450 subjects to see if a behavioral~     weight management program is successful in helping military female personnel who are pregnant~     or post-partum to manage their weight during and after their pregnancy.~   "
38879|NCT03057795|"~     This phase II trial studies how well nivolumab and brentuximab vedotin work after stem cell~     transplant in treating patients with high-risk classical Hodgkin lymphoma that has come back~     or does not respond to treatment. Monoclonal antibodies, such as nivolumab and brentuximab~     vedotin, may interfere with the ability of cancer cells to grow and spread.~   "
38880|NCT03057782|"~     It is difficult to assess pain and agitation in the NICU population because for a multitude~     of reasons including the pre-verbal nature of the patient population, the atypical pain~     response of premature infants, and the use of muscle relaxing medications that exclude motor~     response in pain assessments. Current assessment tools are based on physical exam and vital~     signs. The investigators propose to study the role of EEG and palmar conductance (PD) as~     additional tools in the assessment of pain and agitation~   "
41261|NCT03026647|"~     Retrospective chart review evaluating different suture types on surgical outcomes for~     cesarean delivery and vaginal birth after cesarean delivery outcomes when different sutures~     are used.~   "
38881|NCT03057769|"~     Acute pancreatitis is the most common and feared complication of ERCP, occurring after 1% to~     30% of procedures. It accounts for substantial morbidity and represents a substantial cost to~     health-care systems. European Society of Gastrointestinal Endoscopy and Japanese Society of~     Hepato-Biliary-Pancreatic surgery guidelines and recently large-scale RCT recommended routine~     use of NSAIDs indomethacin rectally before ERCP. Nonsteroidal anti-inflammatory drugs~     (NSAIDs) have been shown to inhibit prostaglandin synthesis, phospholipase A2 activity, and~     neutrophil/endothelial cell attachment, which is believed to play a key role in the~     pathogenesis of acute pancreatitis.~      Other possible mechanisms have been suggested in the occurrence of pancreatitis. Papillary~     edema caused by manipulations during cannulation or endoscopic treatment has received the~     most attention. The papillary edema may cause temporary outflow obstruction of pancreatic~     juice, and then increase ductal pressure, resulting in the occurrence of pancreatitis.~     Topical application of epinephrine on the papilla may reduce papillary edema by decreasing~     capillary permeability or by relaxing the sphincter of Oddi. A meta-analysis (including 2~     existing RCTs and post-hoc analysis of our previous study) of papillary epinephrine spraying~     compared with saline spraying or no intervention indicates a potential relative risk~     reduction of PEP (RR 0.34, 95%CI 0.19-0.61). Papillary epinephrine spraying may be an~     inexpensive and convenient alternative for prevention of post-ERCP pancreatitis. A large~     pragmatic RCT to determine whether routine using papillary epinephrine spraying can reduce~     post-ERCP pancreatitis is needed.~   "
38882|NCT03057756|"~     The principal objective is to evaluate a cure rate and number of adverse events of with~     confirmed multidrug-resistant tuberculosis patient treated with a 9months regimen.~   "
38883|NCT03057743|"~     Pilot study using [18F]ISO-1 PET/CT to image sigma-2 receptor binding in metastatic breast~     cancer. Correlate baseline uptake and change in uptake after therapy with time to progression~     and standard and experimental pathology assays of biopsy or surgical tissue. The target~     population is up to 30 adult patients at least 18 years, with at least one site of disease~     outside the liver by at least one type of standard imaging.~   "
38884|NCT03057730|"~     Gingival recession is a common defect among the American population. It is also a major cause~     for root decay, hypersensitivity, contributes to tooth mobility and low self-esteem.~     Acellular dermal matrix, a human-derived grafting material has been put on the market for the~     treatment of gingival recession. Treating gingival recession with this material has been a~     validated treatment option for years.~      However, treatment outcomes in two patient populations, namely those with thin biotypes and~     those with thick biotypes, has not been investigated. This study will observe the primary~     treatment outcomes in the two patient groups at 5 time points - 3 months, 6 months and 12~     months post-surgery to observe short term outcomes; additional 24 months and 48 months~     post-surgery to observe long term outcomes.~   "
38885|NCT03057717|"~     Administration of corticosteroids is standard practice for pregnant patients at risk of~     preterm labour to reduce the risk of neonatal respiratory distress syndrome, intraventricular~     hemorrhage, necrotizing enterocolitis and neonatal mortality. However, there is an unknown~     effect of antenatal steroids on both fetal and neonatal immune function. The purpose of this~     study is to demonstrate the effect of antenatal steroids on the size of the fetal thymus~     gland.~   "
38886|NCT03057704|"~     Intravenous lidocaine is commonly given through an intravenous (IV) line prior to injection~     of propofol to reduce the amount of pain during propofol injection. The investigators want to~     study if giving the lidocaine through the IV while the forearm on the same limb has a~     tourniquet applied to it to prevent washing out of the lidocaine prior to propofol~     injection helps reduce propofol injection pain.~   "
38887|NCT03057691|"~     The purpose of this study is to evaluate how major depressive disorder or generalized anxiety~     disorder could effect the prognosis of the patients post-ACS after PCI and whether the~     treatment or improvement of depression and anxiety could improve their prognosis.~   "
38888|NCT03057678|"~     Otologic surgery often involves a mastoidectomy to safely access the inner ear. In this~     procedure, a portion of the mastoid part of the temporal bone is removed. The surgery is~     lengthy and challenging because many critical structures are embedded in the mastoid and are~     difficult to identify and accurately remove with a surgical drill. In previous work, the~     investigators developed a compact, bone-attached robot to automate mastoidectomy drilling for~     translabyrinthine acoustic neuroma removal (TANR). The robot does not attach directly to the~     bone. Instead, a rigid surgical fixture which the investigators call a prepositioning frame~     (PPF) is attached to the temporal bone, and the robot attaches to the PPF. Attaching the~     robot to the participant eliminates the need for an expensive image guidance system to~     compensate for participant motion, but requires a compact robot with a limited range of~     motion. The PPF supports the robot on the head such that a planned mastoidectomy volume is~     within the robot's range of motion. In this study, the investigators plan to test the PPF by~     attaching it to ten participants. By processing an intraoperative CT scan of the attached~     PPF, the investigators will measure the percentage of each planned mastoidectomy that would~     be reachable if the robot were attached. The investigators will also measure the time~     required to attach the PPF. The data the investigators acquire will enable further~     improvements to the PPF design, which would be advantageous before proceeding to robotic~     drilling experiments.~   "
38889|NCT03057665|"~     The goal of this study is the evaluation of an atomic magnetometer that is practical for~     human biomagnetism studies. The investigators have built a device that has the necessary~     sensitivity, and will be testing it on a small number of adults and approximately 30 healthy~     pregnant subjects, in preparation for beginning pre-clinical studies of high-risk~     pregnancies.~   "
38890|NCT03057652|"~     The purpose of this study is to develop an algorithmic-based evaluation and treatment~     approach for wearable robotic exoskeleton (WRE) gait training for patients with neurological~     conditions.~   "
38891|NCT03057639|"~     This research trial studies the Adolescent and Young Adult (AYA) Cancers Clinical Model in~     evaluating clinical, psychosocial, and health economic factors in adolescent and young adult~     patients with cancer. Studying the Adolescent and Young Adult Cancers Clinical Model may help~     doctors learn more about the effect of the AYA services on patient care, including clinical~     (nurse navigation), psychosocial (social work), and economic (financial) areas.~   "
38893|NCT03057613|"~     A small group of skin cancers of the head and neck, called resected cutaneous squamous~     carcinomas, are more aggressive than most cancers of this type, even after being treated with~     standard therapy. This trial will use stronger treatment to look at the safety and~     effectiveness (efficacy) of combining a drug called Pembrolizumab with radiation after a~     cancer has already been treated to suppress secondary tumor formation in high risk cutaneous~     squamous cell cancer of the head and neck.~      Primary Objective To assess safety by looking at the people with dose limiting responses~   "
38894|NCT03057600|"~     CX-839-007 is an open-label Phase 2 study of the combination of CB-839 with paclitaxel in~     patients of African ancestry and non-African ancestry with advanced triple negative breast~     cancer. Multiple single-arm cohorts will be enrolled in which 800 mg BID CB-839 will be~     administered in combination with the full approved dose of paclitaxel.~   "
38895|NCT03057587|"~     This study will be an observational, prospective trial that will measure the cerebral~     oxygenation of infants scheduled to undergo general anesthesia at Boston Children's Hospital.~   "
38896|NCT03057574|"~     This study aims to record Efficacy, Safety and tolerability of Gonapure® prescribed for~     female subjects with infertility Undergoing IVF/ICSI~   "
38897|NCT03057561|"~     This project is designed to demonstrate equivalence of Dotarem enhanced LGE-CMR (late~     gadolinium enhancement cardiac MRI) with Magnevist enhanced LGE-CMR from the standpoint of~     visual image quality, quantitative image quality, and association with clinical outcomes.~   "
38898|NCT03057548|"~     The purpose of this study it to learn whether pulmonary vein isolation (PVI) along with~     ablation of the posterior left atrial wall (PLAW) will reduce the likelihood of atrial~     fibrillation (AF) recurrence in patients with persistent or long-standing persistent AF one~     year after an ablation procedure in comparison to a PVI ablation procedure, alone.~      The investigator hypothesizes that the combination of PVI plus PLAW isolation will result in~     a reduction in recurrence of atrial arrhythmias at one year after ablation.~   "
38899|NCT03057535|"~     An abnormally high V̇E/V̇CO2 response to exercise is a key pathophysiological feature of~     patients with chronic cardiopulmonary disease that is associated with adverse health~     outcomes. It follows that any intervention capable of decreasing the V̇E/V̇CO2 response to~     exercise has the potential to improve clinical and/or patient-reported outcomes. The~     investigators of this trial will compare the effects of orally administered sodium chloride~     (4 g, placebo) and sodium bicarbonate (0.3 g/kg of body mass) on ventilation, breathing~     pattern, dynamic operating lung volume, gas exhange, cardiovascular, metabolic and symptom~     parameters during symptom-limited, high-intensity, constant-work-rate cycle exercise testing~     in healthy adults aged 20-40 years.~   "
38900|NCT03057522|"~     This will be a pilot study to determine if a 6 week home training program can increase~     preferred step rate (cadence) in recreational runners. Increase in step rate has been~     correlated with decreased stress at lower limb joints in runners. This has the potential of~     decreasing overuse injuries in this population.~      Research participants will have their preferred cadence evaluated at the beginning of the~     study. The athletes will be randomly assigned to two groups. One group will continue to train~     without intervention and the other group will train at a cadence of 10% higher than their~     preferred step rate.~      At the end of 6 weeks the participants will have their preferred cadence reevaluated using~     the same method as pre-participation cadence was determined.~      The investigators hypothesis the preferred running cadence of recreational runners following~     the intervention will be 5-10% greater than prior to the intervention and the increased~     cadence will be maintained for 6 months following the intervention.~   "
38901|NCT03057509|"~     This research study is designed to evaluate a type of scan called Ga-68-DOTA-TOC positron~     emission tomography (PET) scanning as a way of assessing carcinoid tumors.~   "
38902|NCT03057496|"~     This study evaluates a novel collision warning device to help people with severe vision~     impairment or blindness avoid collisions with obstacles. The main hypothesis to be tested is~     that the device reduces the number of collisions with obstacles in everyday activities.~   "
38903|NCT03057483|"~     Rationale and background: Since 2013, IB has been performing passive pharmacovigilance~     activities related to TIV. Objetive: To implement an active surveillance study as part of our~     pharmacovigilance plan while passive surveillance activities will continue. Pharmacovigilance~     data on TIV, via active surveillance, is being implemented in response to WHO requirements~     for pre-qualification of TIV.~      Study Design: This is a prospective cohort study. Population: Target groups for vaccination~     defined by The National Immunization Program of Brazil: children between six months and five~     years old; pregnant women; postpartum women (mothers until 45 days after birth); healthcare~     workers; and elderly (people over 60 years old). Study Size: A total of 900 individuals (300~     health care workers, 300 elderly, 100 pregnant women, 100 post-partum women and 100 children~     between six months and five years old), presenting for immunization with IB TIV, and who~     agree to participate after providing Informed Consent.~      Data Analyses: Descriptive approaches will be used to meet the defined objectives described~     in the protocol, as well as formal statistical tests when appropriate.~   "
38904|NCT03057470|"~     The overall objective of this study is to investigate the glycemic response of a 0%, 50%,~     100% and 150% bolus insulin correction (based on personal insulin correction factor) of~     post-exercise hyperglycemia in physically active adults with type 1 diabetes (T1D) using~     multiple daily injections (MDI) in a controlled, but clinically representative, experimental~     setting.~   "
38931|NCT03057119|"~     Substance misuse is a common problem among HIV+ individuals. Research suggests that a~     Screening, Brief Intervention, and Treatment (SBIRT) model can be effective in reducing~     substance misuse in the general older adult population; however these findings have not been~     verified in the more vulnerable HIV+ older adult population. The present study seeks to~     address the problem of substance misuse in older HIV+ adults by piloting a SBIRT model for~     older HIV+ adults in a in a primary care setting. Individual reductions in alcohol and drug~     use can have significant effects on public health and safety when observed over a large~     population at risk for substance use problems. With wider dissemination statewide, a~     relatively low-cost intervention such as SBIRT could offer demonstrated benefits in this~     population.~   "
43066|NCT03003065|"~     In this study, we hope to evaluate the safety of PDT using temoporfin plus endoscopic stents~     in patients with inoperable bile duct cancers. In addition as a preliminary study we sought~     to determine if the treatment can reduce tumor volume in the short term.~   "
38905|NCT03057457|"~     The NGAL TestTM is a particle-enhanced turbidimetric immunoassay for the quantitative~     determination of neutrophil gelatinase-associated lipocalin (NGAL) in human EDTA plasma for~     testing on automated clinical chemistry analyzer.~      The First Indication for Use: An NGAL test result above the assay cutoff as an aid in the~     risk assessment for the development of stage II or III acute kidney injury (AKI) within 1 day~     of patient assessment in patients in the intensive care unit (ICU) who are hypotensive~     (MAP<70 mmHg) and/or receiving vasopressor support. Second Indication for Use: In patents~     with stage II or III AKI, NGAL measurement aids in the risk assessment of the development of~     persistent (≥2 days) stage 2 or 3 AKI.~      The Primary Objective for this clinical trial is to validate that the NGAL test using a~     cutoff of 140 ng/ml shows clinical performance in predicting the development of moderate or~     severe acute kidney injury within 1 day. The Secondary Objective is to validate that the NGAL~     test shows clinical performance in predicting persistent moderate or severe acute kidney~     injury during any contiguous 2 day interval.~      It is anticipated that up to 20 Clinical Sites in US will participate in the trial. The study~     sites will recruit consecutive patients meeting the inclusion and exclusion criteria who are~     admitted to hospital in an ICU or critical care setting. Patients will receive their clinical~     standard of care including standard laboratory and other testing as requested by each~     subject's physician.~   "
38906|NCT03057444|"~     The aim of the study is to investigate, if resistant starch type III increases~     butyrate-producing bacteria in the gut of (pre-) diabetic subjects. Diabetic blood parameters~     are also of interest.~   "
38907|NCT03057431|"~     The investigators plan to assess the efficacy of standard and low dose HCTZ treatment in the~     recurrence prevention of calcium-containing kidney stones. More specifically, the~     investigators aim to assess the dose-response relationship for three different dosages of~     HCTZ.~      Study intervention: HCTZ 12.5 mg, 25 mg or 50 mg once daily per os for 24 or 36 months. In~     addition, all patients in HCTZ treatment arms will receive state-of-the-art non-pharmacologic~     recommendations for stone prevention according to current guidelines.~      Control intervention: Placebo once daily per os for 24 to 36 months. In addition, all~     patients in the placebo arm will receive state-of-the-art non-pharmacologic recommendations~     for stone prevention according to current guidelines.~   "
38908|NCT03057418|"~     This is an open-label study of safety, tolerability, pharmacokinetics and pharmacodynamics of~     Auriхim multiple doses in patients with recurrent/ refractory В-cell, CD20-positive~     non-Hodgkin lymphoma of low tumor grade or with follicular lymphoma, as well as in patients~     non-treated before for В-cell, CD20-positive non-Hodgkin lymphoma of low tumor grade.~      The study will be carried out in 4-6 Russian and Belarussian sites. The study will be~     consisted of screening period, induction (obligatory) phase and supporting (non-obligatory)~     phase of the investigational therapy and post-treatment follow-up period.~   "
38909|NCT03057405|"~     Background Correction of post traumatic and post-ablative orbita defects remains a challenge~     for the maxillofacial surgeon. The purpose of such intervention is the restoration of both~     function and aesthetics by anatomical reconstruction of the bony orbitawalls, with attention~     to the orbitavolume. Unfortunately, the results of such interventions today are still~     somewhat unpredictable.~      The aim of this study is to determine whether 3D virtual planning combined with~     intra-operative navigation can increase the predictability of the outcome in function and~     aesthetics.~      Study design Retrospective study. Demographic data, diagnostic and surgical parameters will~     be collected of all patients undergoing orbital surgery between 01/01/2012 and 31/12/2016 at~     the department. Pre- en postoperative orbit volume will be determined based on CT-analysis in~     Brainlab software, and compared to the non-defected orbit.~   "
38910|NCT03057392|"~     Immersion to the neck before and during hemodialysis session may increase intravascular~     volume, potentiate the ability to ultrafiltrate excess water, with less symptoms of shock,~     muscle crumps etc.~      The aim of the present study is to compare blood volume, hemodynamic and endocrine parameters~     of chronic ESRD patients undergoing forth dialysis session in water immersion vs. control~     regular session.~   "
38911|NCT03057379|"~     The overarching goal of this study is to evaluate the effectiveness, cost-effectiveness and~     sustainability of utilizing statewide Immunization Information Systems (IIS) to conduct~     centralized reminder/recall (R/R) to improve Human Papiloma Virus (HPV) vaccination rates~     among adolescents ages 11-17.~   "
38912|NCT03057366|"~     The purpose of this study is to assess the mass balance (that is, cumulative excretion of~     total radioactivity [TRA] in urine and feces) of pevonedistat following a single 1-hour~     infusion of 25 milligram per square meter (mg/m^2) [14C]-pevonedistat intravenous (IV)~     solution containing approximately 60 to 85 microcurie (mCi) (approximately 2.22-3.145~     megabecquerel [MBq]) of TRA in participants with advanced solid tumors in Part A.~   "
38913|NCT03057353|"~     To measure ligamentum flavum thickness in patients with different nationalities, sexes,~     heights, ages, and weights from Xinjiang Uygur Autonomous Region of China with CT, explore~     the correlation between various factors and ligamentum flavum thickness, provide reference~     for pedicle screw placement and lumbar decompression surgery, develop individualized surgical~     programs, and can effectively reduce the incidence of unnecessary postoperative complications~     induced by misplacement.~   "
38932|NCT03057106|"~     Durvalumab is a new type of drug for many kinds of cancer. It is considered immunotherapy~     and not chemotherapy. Laboratory tests show that it works by allowing the immune system to~     detect cancer and reactivate the immune response. This may help to slow down the growth of~     cancer or may cause cancer cells to die. Durvalumab has been shown to shrink tumours in~     animals and has been studied in more than 5000 people and seems promising.~      Tremelimumab is a new type of drug for various types of cancers. It works in a similar way to~     durvalumab and may improve the effect of durvalumab. Tremelimumab may also help slow the~     growth of the cancer cells or may cause cancer cells to die. It has been shown to shrink~     tumours in animals and has been studied in over 1200 people and seems promising.~   "
38933|NCT03057093|"~     Study was performed to identify ECG criteria for unmasking of subjects with NSTEMI at~     elevated risk.~   "
39233|NCT03053141|"~     The objective of the RHAPSODY study is to evaluate the performance of new software features~     in subjects undergoing standard of care catheter-based endocardial mapping for atrial or~     ventricular tachyarrhythmias using a commercial Rhythmia Mapping System. Results from this~     study will be used to guide development and refinement of new software features that may be~     implemented in future commercial software releases.~   "
38914|NCT03057340|"~     Malignant tumor has become the leading cause of death in humans, and the number one killer in~     malignant tumor is the lung cancer. Intensifying environmental pollution comes with rising of~     the incidence of lung cancer and the high mortality,what's the worst that the 5-year survival~     rate is only about 15%, accounting for first place in the malignant tumors, Exploiting for~     novel antitumor technology and products comes to arrest growing attention of the governments~     and businesses because of the uneffectively curbing of tumor threat to people's life and~     health on conventional three treatments (surgery, radiotherapy and chemotherapy). Biological~     and immunotherapy was voted to one of the ten big breakthrough in 2013 by Science magazine,~     and considered as a new development direction for cancer treatment in the 21st century.~      The existing immune treatment mainly includes: adoptive immune therapy, tumor vaccine~     therapy, immune checkpoint-antibody therapy and other auxiliary therapy, and the adoptive~     immunotherapy was researched and developeded former in addition the most mature treatment~     among these therapies.~      Recently, Dr Hu Hong - Ming's team put forward an innovative cancer treatment strategy: using~     of autophagy role to capture tumor antigen for preparation of tumor vaccine. In this~     strategy, the blocking proteasome activity of in vitro cultured tumor cells dealed with~     Bortezomib (proteasome inhibitors) causes enrichment of short-lived protein (SLiPs) and~     misfolded proteins (DRiPs) in autophagosome,called DRibbles corpuscle. Tumor vaccine maded~     from collecting these DRibbles corpuscle preparation as, also known as the DRibble vaccine.~      At present, clinical research has been carried out about Dribble liver cancer vaccine unit~     with DC - CIK therapy in liver cancer in the second hospital of Nanjing nearly four years,and~     more than 300 cases has been completed. Clinical research results show that Dribble vaccine~     has good security, producing stronger immune response compared with the DC-CIK therapy alone.~     But it is still no cognization for the efficacy and safety of DC-CIK joint DRibble lung~     cancer vaccine in China, whether it is better than the current DC - CIK immune therapy,~     needed for further clinical research and expected to provide a better immune treatment for~     NSCLC patients.~   "
38915|NCT03057327|"~     The proposed study is a pilot and feasibility study designed to develop materials to enhance~     early detection of melanomas among women at risk to develop melanoma due to indoor tanning,~     having a family history of melanoma or a personal history of melanoma.~      The hypothesis of this study is that women, who are engaged in health promotion by having~     mammograms, will be able to assess the personal relevance of skin self-examination (SSE), be~     interested in learning about SSE and able to implement SSE while they are partially disrobed~     in the privacy of the changing room in the mammogram facility.~   "
38916|NCT03057314|"~     To improve the function and welfare of late stage solid cancer subjects by:~        -  enabling subjects to benefit from a potentially promising drug under development~        -  assessing initial evidence of improvement in Pain VAS score~        -  assessing initial improvement in Performance Status (PS)~        -  assessing initial improvement in oxygen saturation whenever it is feasible~   "
38917|NCT03057301|"~     Worldwide, glaucoma is the most common cause of irreversible blindness. The major risk factor~     is raised pressure within the eye (intraocular pressure, IOP). IOP is typically measured~     using Goldman applanation tonometry (GAT). This involves instilling anaesthetic eye drops and~     using a probe to contact the cornea and obtain a pressure measurement. A major disadvantage~     of GAT is that only limited numbers of pressure measurements can be obtained, whereas IOP is~     known to vary throughout the day and in ¾ of people is highest during the night. The result~     is that clinicians have poor understanding of patient's 24 hour IOPs and the effect that this~     might have on their glaucoma. This is a serious limitation as the treatment of glaucoma~     depends on lowering IOP.~      Recently a new device has become available, designed specifically for home IOP monitoring.~     The iCare HOME tonometer is a CE marked commercial device~     (http://www.icaretonometer.com/products/icare-home-tonometer/) that can be used to gain~     insight into 24-hour IOP fluctuations. We wish to determine the feasibility of home IOP~     monitoring using this device. The iCare HOME tonometer depends on the patient performing~     self-tonometry. Testing one's own IOP may be technically difficult and it is likely that~     large numbers of patients will struggle with this.~   "
38918|NCT03057288|"~     It is a multicenter prospective observational study including consecutive patients with~     esophageal tumor or rectum with indication for radiotherapy~      The main objective of this study is to evaluate the feasibility of fiducial markers placement~     under EUS guidance. The evaluation criteria are:~        -  Success rate evaluation of the placement of two markers : one in the upper part of the~          tumor and one in the lower part. Success of the procedure will be evaluated by the~          endoscopist at the end of the procedure. Pictures of the markers will objectify the good~          placement of the markers.~        -  Complications (early within 24 hours and late complications) such as pain, bleeding,~          perforation, infection, migration of the markers~        -  The length of the procedure~        -  The costs (procedure, hospitalization)~        -  The clinical efficacy, by studying the decrease of the estimated target volume, the~          decrease of the dose delivered to the healthy tissue and the improvement of positioning~          of the irradiation beams by the radiotherapy technician~        -  The presence of the markers at the end of the radiotherapy~   "
38919|NCT03057275|"~     To study the equivalence of the Monica Novii™ Patch System in patients admitted for~     threatened pre-term labor and for pre-term labor & delivery from 32 +0 weeks gestation by~     determining the equivalence of the Novii™ Patch System in monitoring Fetal Heart Rate (FHR),~     Maternal Heart Rate (MHR) and Uterine Contractions (UC) to Doppler FHR, tocodynamometer~     (TOCO) UC and photo plethysmograph MHR FDA approved predicates.~   "
38920|NCT03057262|"~     Intra-articular temporomandibular disorders are often related to pain in the area of~     temporomandibular joint, ear and temple. The aim of the study was to investigate the~     efficiency of anterior repositioning splints for the management of pain related to~     temporomandibular joint disc displacement with reduction.~   "
38921|NCT03057249|"~     The purpose of this study is to evaluate the consequences of 3 selected surgical procedures~     on abdominal wall perfusion in order to help to reduce postoperative complication related to~     inadequate tissue perfusion. The selected surgical procedures are a) abdominoplasty, b)~     breast reconstruction with a free flap from the lower abdomen and c) endovascular stenting of~     an abdominal aorta aneurism. These operations are all standard surgical procedures frequently~     performed at the University Hospital of North Norway, Tromsø. The abdominal wall perfusion~     will be evaluated with the use of Dynamic Infrared Thermography (DIRT).~   "
38922|NCT03057236|"~     This is a pilot feasibility study of a small randomized controlled trial (RCT)design to~     evaluate participation in a Cognitive Behavioral Coping Skills (CBCS) group intervention~     versus standard of care in patients with hepatitis C undergoing antiviral treatment. The~     primary objectives are to (1) examine effect size (ES) estimates of key outcomes to provide~     essential data to inform a larger efficacy trial, (2) determine whether clinically~     significant improvements occurred in any key outcomes, and (3) evaluate study feasibility and~     patient acceptability. Study findings will inform a larger efficacy study of the CBCS-HCV.~   "
38923|NCT03057223|"~     Medical titanium plates are routinely used in fixing mobilized bone segments in jaw~     surgeries. Generally these plates are commercialized with standard construction~     specifications. Thus they should be repeatedly bended and arched to match the contour of~     anchored jaw bones before located in place and fastened by screws. To prevent stress fatigue~     induced by plate bending and improve structural design, we utilized the three-dimensional~     printing technique and developed a new production procedure in fabricating customized~     titanium plates according to each patient's specific skeletal contours and dimensions derived~     from medical imaging data. In general, the three-dimensional printing of customized implants~     are expected to facilitate surgical operation, reduce application duration and improve~     precise restoration.~      Up until now, the application of three-dimensional printing of titanium fixation plates in~     jaw surgery has been available only at two centers globally. The published preliminary work~     have proved the prospect of customized titanium plates in promoting mandibular reconstruction~     surgery and upper maxilla orthognathic surgery though their printed titanium plates looked~     rather bulky and the sample sizes were small and there is still lack of qualified randomized~     controlled trials between the printed and the conventional titanium plates. To better benefit~     from the burgeoning use of three-dimensional printing in health care, it is imperative to~     conduct a feasibility study in exploring the application of three-dimensional printing of~     titanium fixation plates in jaw surgery based on our patients.~      The aim of the study is to conduct a case series study focusing on the feasibility and safety~     of applying three-dimensional printed titanium plates in jaw reconstruction surgery and~     orthognathic surgery. The outcome measures include the success rate, potential adverse events~     and accuracy. A sample size of 48 subjects will be recruited prospectively. Considering the~     facts that titanium plates are widely used in jaw surgery and our unit is the largest oral~     and maxillofacial surgery center in Hong Kong, the well-designed customized titanium plate is~     therefore with great potential benefit for the patients in our population. Furthermore, the~     well-developed three-dimensional manufacturing protocol could also be applied in other~     relevant medical areas and push forward the personalized medicine era in the future.~   "
38924|NCT03057210|"~     Introduction: Post-exercise recovery techniques have been extensively investigated in order~     to optimize the restoration of various body functions and consequently of performance.~     Massage represents approximately 45% of the time spent by a sports physiotherapist in the~     field, however, their mechanisms are not well established and studies present divergent~     results in the literature.~      Objectives: The objective of this study is to analyze and compare the effects of massage when~     applied immediately or 1 hour after physical exertion, on functional, clinical and metabolic~     variables.~      Design: A cross-over randomized clinical trial.~      Participants: Forty men aged 18 to 30 years, healthy and that fulfilling the eligibility~     criteria.~      Procedures: Participants will be randomized into five groups (n = 8 per group): (GA, GB, GC,~     GD and GE), which will perform the 5 stages of the study at randomized times, one stage per~     session. Stage 1: control; Stage 2: Participants will receive the massage protocol; Stage 3:~     physical exercise protocol; Stage 4: Participants will perform the physical exercise protocol~     and immediately after, will receive the massage; Stage 5: Participants will perform the~     physical exercise protocol and 1 hour after the end of the exercise they will receive the~     massage. Sessions will occur with a 1-week interval between them.~      Measurements. The primary outcome measures will be measured 2h after the start of each stage,~     and the secondary outcome measures will be measured at specific times during each stage. The~     primary outcome includes measures of functional performance, and the measures of secondary~     outcome includes clinical and metabolic variables.~   "
38925|NCT03057197|"~     Caudal epidural injections have been commonly performed in patients with low back pain and~     radiculopathy. Conventional caudal epidural injections, which the needle is advanced into the~     sacral canal, present a potential risk of penetration of the epidural venous plexus or dura.~     The investigators hypothesized that a new caudal injection technique, which the needle only~     penetrates the sacrococcygeal ligament without being inserted into the sacral canal, might~     represent a safe alternative, with a lower incidence of intravascular injections and~     patient's discomfort during the procedure than the conventional technique. The study is~     designed to investigate the influence of the depth of the inserted needle on successful~     epidurogram and clinical outcome in caudal epidural injections under the ultrasound and~     digital subtraction angiography.~   "
38926|NCT03057184|"~     Adult Day Care Centers (ADCC) offer important relief and rest services for family caregivers.~     However, some caregivers report that behavioral and psychological symptoms of dementia (BPSD)~     arise when they prepare dependents for the ADC, especially when they have dementia. This~     issue increases stress for caregivers and contributes to a worsening of their mental health~     and quality of life. The present study evaluates the effectiveness of a behavioral~     intervention program aimed at reducing the reluctance of the dependent to attend the ADCC. We~     hope that reducing resistance will have a positive influence on the mental health of~     caregivers.~   "
38927|NCT03057171|"~     Helicobacter pylori (H.pylori) is a major human pathogenic bacterium in gastric mucosa which~     is linked to the development of gastritis, peptic ulcer disease, mucosa-associated lymphoid~     tissue lymphoma and gastric cancer. However the regulatory mechanism of H.pylori-induced~     immune response is not clear. Long non-coding RNA (lncRNA) has recently emerged as key~     post-transcriptional regulators of gene expression, differentiation. The investigators had a~     preliminary results which THRIL (TNFα and hnRNPL related immunoregulatory lincRNA) and~     PACER(p50-associated COX-2 extragenic RNA) played a potential role in H.pylori induced~     inflammatory cascade. However, there wasn't a previous study about expression of THRIL, PACER~     in a human tissue. Therefore, the investigators aimed to evaluate the expression of THRIL,~     PACER in patients with gastrointestinal disease according to H.pylori infection.~   "
38928|NCT03057158|"~     Millions of women suffer from overactive bladder, and the changes in bladder function affect~     their quality of life. The study team believes that it needs to be better understand why~     women get overactive bladder in the first place so that better treatments can eventually be~     offered.~      The purpose of this study is to determine why women with insulin resistance are more likely~     to get overactive bladder. Overactive bladder is a type of bladder control problem that can~     cause some women to have bladder leakage. This problem is more common in women with diabetes~     and pre-diabetes, but it isn't known why.~   "
38929|NCT03057145|"~     This research study is studying a combination of targeted therapies as a possible treatment~     for Advanced Solid Tumors.~      The study interventions involved in this study are:~        -  LY2606368~        -  Olaparib~   "
38930|NCT03057132|"~     The objective of this pilot study is to evaluate the feasibility, safety and efficacy of 3M™~     Cavilon™ Advanced Skin Protectant when used in the management of damaged skin exposed to~     caustic body fluids from an ostomy, drain site or fistula.~   "
39012|NCT03056066|"~     The purpose of this study is to assess the accuracy of FRC and airway resistance calculate~     values of Spircare device as compared to the conventional body plethysmograph in healthy~     adults and patients with obstructive and restrictive pulmonary diseases/disorders.~   "
39013|NCT03056053|"~     The main study objective is to assess the content validity and the psychometric~     characteristics of the Insomnia Daytime Symptoms and Impacts Questionnaire™ (IDSIQ™).~   "
38934|NCT03057080|"~     The aim of our study was to evaluate the technical and clinical effectiveness of PTA in the~     management of ischemic foot ulcers. All consecutive patients presenting with a foot ulcer at~     the outpatient Vascular surgery clinic of our hospital were evaluated. If non-invasive~     parameters suggested peripheral arterial disease (PAD) anatomic imaging (CTA and/or DSA) was~     performed and a PTA was carried out when feasible during the same session. All patients were~     followed until healing, amputation, death, or for at least two years. Short-term and~     long-term clinical success of PTA was evaluated based on ulcer size and appearance. Patients~     with worsening ulcers after PTA underwent bypass grafting or amputation.~   "
38935|NCT03057067|"~     Results of recent systematic reviews suggest favorable results of embolization for the~     treatment of Pelvic Congestion Syndrome (PCS) compared with pre-procedure symptoms for~     several outcomes, including pain reduction, overall patient satisfaction, and technical~     feasibility. Reported complication rates appears relatively low.~      Pelvic vein embolization is a relatively new technology and the results may provide~     background for an evidence based decision to offer embolization of pelvic varicosities for~     women with PCS in Norway.~   "
38936|NCT03057054|"~     This randomized clinical trial studies how well Lactobacillus plantarum works in preventing~     acute graft versus host disease in children undergoing donor stem cell transplant.~     Lactobacillus plantarum may help prevent the development of gastrointestinal graft versus~     host disease in children, adolescents, and young adults undergoing donor stem cell~     transplant.~   "
38937|NCT03057041|"~     Intranasal fentanyl has been found to be safe and effective in the reduction of pain among~     pediatric and adult populations. The investigators hypothesize that patients who receive 100~     mcg of intranasal fentanyl for pain control before first-trimester uterine aspiration will~     report lower pain scores than those who receive placebo. The investigators will test this~     hypothesis using a randomized, double-blind, placebo-controlled trial comparing pain reported~     during uterine aspiration between patients who receive either intranasal fentanyl or~     intranasal saline prior to the procedure.~   "
38938|NCT03057028|"~     Pulmonary arterial hypertension (PAH) can result in right ventricular failure and death.~     Anakinra has been used in patients with left sided heart failure, and the present study looks~     to determine if anakinra is safe and effective in patients with PAH. To accomplish this goal,~     we plan to evaluate for exercise improvement (as assessed by cardiopulmonary exercise~     testing) in 10 patients with PAH on anakinra.~   "
38939|NCT03057015|"~     Total knee arthroplasty (knee replacement) is a common orthopedic procedure for~     osteoarthritis. This procedure is performed either under general anesthesia or spinal~     anesthesia; after the procedure in the recovery room, these patients undergo adductor canal~     block, which is a nerve block to provide 8-14 hours of postoperative pain control. For this~     nerve block, 15-20 ml of local anesthetic is combined with adjuvant medications to improve~     the quality of pain control as well as the duration of pain relief. The primary local~     anesthetic used for adductor canal block is ropivacaine, and the commonly used adjuvants are~     epinephrine and dexamethasone.~      There is conflicting data available in the literature regarding efficacy of addition of~     clonidine to the local anesthetic injection in peripheral nerve blocks, and there is no data~     assessing the efficacy of this medication in adductor canal blocks.~      Once the consent process is completed, patients are enrolled in two arms. Upon conclusion of~     surgery, a sealed and coded envelope with either clonidine or the placebo syringe will be~     given to the acute pain service staff performing the nerve block. This will be mixed with~     local anesthetic solution and injected in the adductor canal under ultrasound guidance.~      The primary outcome measure will be the duration of analgesia, which will be assessed as the~     time interval between placement of adductor canal block to the first request of opioid~     analgesic by patients (which will be obtained from hospital electronic medical records).~     Secondary outcomes will include:~        1. Duration of sensory block, which will be assessed as the time interval between injection~          of local anesthetic and report of postoperative pain of 3 or more on an 11 point scale~          (0=no pain; 10= worst pain imaginable) by the patient (this will be assessed every 4~          hours).~        2. Duration of motor block, which will be assessed as the time interval between the onset~          of motor block to complete recovery of motor block by assessing straight leg raise~          strength (this will be assessed every 4 hours).~        3. Cumulative 24 and 48 hour opioid analgesic use.~        4. Post-block pain scores, evaluated by an 11 point pain score (0-10), which will be done~          every 15 minutes for the first hour after surgery and every 4 hours thereafter for 24~          hours.~   "
38940|NCT03057002|"~     In this study the investigators propose to detect early mitochondrial metabolic changes in~     the heart in patients with a positive genotype and phenotype for Hypertrophic Cardiomyopathy~     (HCM) using a novel hyperpolarized [1-13C]pyruvate Magnetic Resonance Imaging (MRI)~     methodology.~   "
38941|NCT03056989|"~     Ascending dose, 7-day, open label safety trial of SPX-101 Inhalation Solution in adult~     subjects with cystic fibrosis.~   "
38942|NCT03056976|"~     The aim of this study is to assess the cost-effectiveness of the mandibular overdenture~     retained by one and two implants and the mandibular fixed prosthesis retained by four~     implants, based on a randomized clinical trial.~   "
38943|NCT03056963|"~     The purpose of this study is to examine the efficacy of a guided imagery paradigm for~     reducing negative ways of thinking about the self. There will be at least 60 participants~     enrolled at the University of Texas at Austin. Participants will be randomly selected to~     receive one of two types of trainings, each over the course of two weeks. Participants will~     undergo the training exercises at home. The training exercises will help them to think~     differently about themselves.~      Participants will be able to determine if they are eligible, and then participate, by filling~     out a screening questionnaire online.~   "
38944|NCT03056950|"~     Occlusion training, resistance exercise performed with a specialized venous tourniquet, leads~     to beneficial changes in muscle strength at low resistance and minimal stress on the nearby~     joint. This novel resistance training has the potential to greatly improve muscle strength~     gains in individuals who are unable, for medical reasons, to perform the high resistance~     exercises typically required to improve strength. Our study will examine the effect of this~     technique on strength recovery following distal radius fracture treated with cast~     immobilization (non-operatively). The primary objective of the intervention is to achieve~     accelerated recovery of forearm, wrist and hand function as assessed using measures such as~     grip/pinch strength, validated questionnaires, and functional outcome testing. Occlusion~     training can potentially serve as a specialty intervention for rehabilitation patients,~     reduce the cost of care, and improve the treatment options for both patients and providers.~   "
38945|NCT03056937|"~     The hypothesis of this study is that reductions in body weight could improve inspiratory~     muscle function attenuating the inspiratory metaboreflex in metabolically healthy obese~     individuals and obese individuals with metabolic syndrome.~   "
39014|NCT03056040|"~     The purpose of this study is to assess ALXN1210 compared to eculizumab in adult patients with~     PNH who are clinically stable on eculizumab for at least 6 months~   "
39015|NCT03056027|"~     Patients scheduled to undergo laparoscopic preperitoneal or open inguinal hernia repair will~     be evaluated by means of scrotal/testicular ecocolordoppler ultrasound investigation before~     and after surgery in order to rule out the potential impact of the surgical procedure on~     testicular arterial and venous blood flow~   "
38946|NCT03056924|"~     Patients with Crohn's disease (CD) and ulcerative colitis (UC) are often treated with~     medications that suppress the immune system. These patients are therefore at increased risk~     for developing infections, such as influenza, pneumonia, and hepatitis B, which may be~     prevented by vaccination. While awareness is increasing among gastroenterologists of the~     importance of vaccinations in the IBD patient, there continues to be some question of the~     effectiveness of vaccination in immunosuppressed patients. It has been previously shown that~     patients on immunosuppressive therapy with certain biologic medications (the TNF-blockers:~     infliximab and adalimumab) had an impaired immune response to vaccination as compared to~     healthy controls, as the mechanism of immunosuppression for these agents is systemic.~     Vedolizumab, a biologic medication for CD and UC approved in May 2014, targets the α4β7~     integrin, a key component of gut immunity, and as such it has been hypothesized that with~     this agent effects are gut specific. There is limited data that suggests that in healthy~     patients given vedolizumab do not have an altered response to parentally administered~     vaccines, however there are no studies in the CD and UC population describing this.~     Additionally, IBD patients treated with vedolizumab are frequently also on concomitant~     therapy with an immunomodulator (6-mercaptopurine, azathioprine, or methotrexate), and these~     patients ability to mount an immune response has not been demonstrated.~   "
38947|NCT03056911|"~     The aim of the study is to evaluate the clinical effects of Ozone-oxygen therapy as~     therapeutic substance for nucleolysis application in the patients with cervical disc hernia~     who had chronic pain and weakness on the neck, shoulders and arms~   "
38948|NCT03056898|"~     Health professionals attending the American Association for Family Physicians (AAFP) meeting~     at the Orlando Convention Center, Sept 21-23, 2016 who visit the DSM Nutritional Products Inc~     booth will be invited to complete an omega-3 dietary intake survey and have a drop of blood~     taken by finger stick by a health professional for blood fatty acid analysis. Dried blood~     samples on filter paper will be sent to an outside laboratory (OmegaQuant LLC) for analysis.~     Within 2 weeks, participants will receive an Omega-3 Index Test report by email from~     OmegaQuant LLC. After removing personal information, OmegaQuant LLC will share blood fatty~     acid and omega-3 dietary intake results with the sponsor.~   "
38949|NCT03056885|"~     This study evaluates the local cytokine inflammatory response during one lung ventilation in~     patients undergoing pulmonary lobectomy or wedge resection. We compare two different~     ventilation strategies: a conventional strategy with a protective strategy.~   "
38950|NCT03056872|"~     Alcohol dependence is among the most common and costly public health problems affecting the~     nation. Among individuals with alcohol use disorder (AUD), those with (vs. without) a~     co-occurring anxiety disorder (AnxD) are as much as twice as likely to relapse in the months~     following AUD treatment. Dysregulation of biological stress-mood systems predict and~     correlate with AUD relapse and AnxD symptomatology. In contrast, stress system re-regulation~     correlates with improved AUD treatment outcomes but has not been examined with respect to AUD~     recovery and relapse in co-occurring AUD+AnxD.~   "
38951|NCT03056859|"~     This is a single-arm observational trial of a device (Compass Vascular Access, Centurion~     Medical Products, Williamston MI). The device is a compact, sterile, single-use extravascular~     blood pressure transducer. This pressure measurement aids in confirmation of appropriate~     venous access. The investigators plan to enroll 40 consenting patients with BMI ≥35 who~     require central venous catheterization for clinical reasons independent of the existence of~     this study. The primary outcome is operator satisfaction.~   "
38952|NCT03056846|"~     The purpose of this research study is to evaluate the effect of a daily supplement of~     probiotics (Lactobacillus gasseri KS-13, Bifidobacterium bifidum G9-1, Bifidobacterium longum~     MM-2) on stress-associated gastrointestinal function in university students during the time~     of semester exams.~   "
38953|NCT03056833|"~     Investigators hypothesize that concurrent ribociclib treatment and chemotherapy will enhance~     the response to platinum-based therapy and maintenance therapy will slow ovarian cancer tumor~     growth leading to prolongation in progression free survival.~   "
38954|NCT03056820|"~     The purpose of this study is to compare the effect of the 25° head-up position versus the 55°~     head-up position on tolerable apnea time (TAT) after induction of general anesthesia in~     patients with a body mass index (BMI) of 30-40.~   "
38955|NCT03056807|"~     The purpose of this study is to compare the effect of the 25° head-up position versus the 55°~     head-up position on tolerable apneic time (TAT) in bariatric patients scheduled for~     laparoscopic adjustable gastric band surgery following maximum preoxygenation and~     rapid-sequence induction (RSI) of anesthesia.~   "
38956|NCT03056794|"~     Children and adults with pyruvate dehydrogenase complex (PDC) deficiency are participating in~     a research study seeking to better understand the genetic causes, symptoms, usefulness of~     current treatments, and outcomes for these disorders. The research project involves~     completing a questionnaire about the individual or family's medical history and experiences~     with PDC deficiency, review of medical records by the researchers, and in some cases,~     advanced genetic testing. A blood draw will be requested, and an optional skin biopsy is part~     of the study for some participants.~   "
38957|NCT03056781|"~     The purpose of this research is to understand how the emotions of people with different~     mental health concerns (e.g., people with schizophrenia, people with major depressive~     disorder) differ from individuals without mental health concerns. A large body of literature~     suggests that people with mental illnesses have emotional abnormalities compared to healthy~     individuals, but a number of these abnormalities are not well understood. For example, often~     people with schizophrenia report on questionnaires that they experience fewer pleasant~     emotions when talking with other people, but some evidence suggests these individuals report~     a similar amount of pleasant emotion when they are actually engaged in a pleasant activity.~     Thus, it is unclear the extent to which reports of emotional abnormalities extend to a more~     real-world setting. In the tasks in the current proposal, participants will engage in a~     series of tasks designed to assess their emotional functioning. These tasks involve viewing~     emotional stimuli on the computer, engaging in social interactions, and consuming small~     amounts of food. In all tasks, participants will make ratings of their experiences of~     pleasure (and displeasure). We will then compare the experiences of patient groups to those~     of healthy individuals to test how emotional ratings might differ across these tasks.~   "
38958|NCT03056768|"~     Objectives: 1-year multidomain health promotion on prevention of physical and cognitive~     decline for community-living older people.~      Design:~      Methods: Randomized controlled trial~      Setting:~      Five cities(Taipei, Taichung, Kaohsiung, Kinmen, I-Lan) in Taiwan Participants: age 65 or~     older community-dwelling prefrail or frail adults Intervention: 1-year multidomain health~     promotion (physical, cognitive, nutritional intervention)~      Measurements:~      Primary outcome includes frailty status and cognitive performance. Secondary outcomes include~     depressive symptoms, nutrition assessment, and functional capacity; All the variables were~     measured at 0, 6, 12 months. The effect of intervention was investigated by~     intention-to-treat analysis.~   "
38959|NCT03056755|"~     Efficacy and safety of treatment with alpelisib plus endocrine therapy in patients with HR+,~     HER2-negative aBC, with PIK3CA mutations, whose disease has progressed on or after CDK 4/6~     treatment with an aromatase inhibitor (AI) or fulvestrant~   "
38960|NCT03056742|"~     This study is being conducted as an extension of the phase II clinical trial~     SRPL/CLI/10-11/001 (NCT01484574). The CDSCO has recommended flexibility for continued~     clinical study in consultation with ICMR, as per recommendation of Cellular biology based~     therapeutic drug evaluation committee (CBBTDEC).~   "
38961|NCT03056729|"~     The primary objective of the study is to evaluate the safety and tolerability of~     single-ascending intravenous (IV) infusions of BIIB076 in healthy volunteers and participants~     with Alzheimer's disease (AD). A secondary objective of the study for both healthy volunteers~     and participants with AD is to assess the serum pharmacokinetic(s) (PK) profile of BIIB076~     after single-dose administration. Another secondary objective is to evaluate the~     immunogenicity of BIIB076 in serum after single-dose administration.~   "
38962|NCT03056716|"~     In thoracic surgery, it is usual to place apical and basal drains for complete drainage of~     air and fluid out of the pleural cavity. The routinely used drains are mainly made of~     plastic. Recently silastic drains of smaller size are used without any complication. The~     investigators designed a prospective randomized trial to compare the draining properties of~     the two types of drains following various resections in thoracic surgery.~   "
38963|NCT03056703|"~     The primary objective of this study is to compare the bioavailability of a single dose of a~     new 1000 mg fast release ASA (acetylsalicylic acid) tablet with that of two tablets of a~     commercially available 500 mg fast release tablet and to test for bioequivalence of the new~     versus the commercial product in healthy adult subjects.~   "
38964|NCT03056690|"~     The purpose of this study is to assess analgesic efficacy of ASP0819 relative to placebo as~     well as the safety and tolerability.~      This study will also assess treatment differences in physical function as well as the~     improvements in overall subject status (e.g., fibromyalgia symptoms and global functioning)~     of ASP0819 relative to placebo.~   "
38965|NCT03056677|"~     After meals, the level of glucose rises in the circulation. In some individuals who are~     overweight and older, blood glucose can rise to levels which can damage tissues and cause~     health problems. Usually the hormone insulin, released from the pancreas, effectively lowers~     blood glucose. However, in overweight and older people insulin is less effective. Certain~     foods can lower the rise in blood glucose, particularly proteins. This works by increasing~     the release of a hormone from the gut called Glucagon-Like Peptide 1 (GLP-1), which in turn~     increases the release of insulin. A Component of milk left over after cheese making, termed~     Whey protein, is particularly good at releasing GLP-1. Whey protein is used as a food~     additive and taken as a supplement to help build muscle. Whey protein is a mixture of~     proteins which the investigators have modified to be more effective at lowering blood~     glucose. Using laboratory tests the investigators identified a protein present in Whey that~     does not increase levels of GLP-1 and removed it. It's removal raises the levels of other~     proteins which are more effective. In this study, the investigators would like to test the~     effectiveness of the modified whey protein. To do this, 30 older, overweight volunteers~     will be recruited and given the modified whey protein, a normal whey protein or a mixture of~     amino acids and then a breakfast meal to raise their blood glucose levels. These drinks will~     be given in a randomised sequence 1 week apart. On each visit, blood samples to measure blood~     glucose and related hormone levels will be taken. As GLP-1 can also have an effect on~     appetite, the investigators will measure the effect of the modified whey protein on~     subsequent appetite in the volunteers by asking them how hungry they feel.~   "
38966|NCT03056664|"~     Here investigators will carry out this phase II clinical trial to explore a effective~     therapeutic regimen of MSC in the Crohn's perianal fistula.~   "
38967|NCT03056651|"~     The Day-Care Unit for Patients With Refractory Heart Failure (DayCare-HF) is an observational~     study on selected patients with advanced refractory heart failure. The purpose of the study~     was to examine the comprehensive management of HF in the day-care unit in terms of the safety~     and its impact on the rehospitalization and mortality rates in patients with advanced~     refractory HF.~   "
38968|NCT03056638|"~     Stereotactic body radiation therapy (SBRT) is a very precise form of radiation therapy that~     allows the physician to deliver more radiation dose in a single session. Because of this, the~     number of radiation sessions can be reduced from the typical 45-48 sessions, as in~     conventional daily session radiation, to 5 sessions given every other day over a week and a~     half. Giving the radiation at a higher dose during each treatment may be more effective in~     killing the prostate cancer cells than the standard way of using external radiation therapy~     where a small amount of radiation is given over many sessions.~      Androgen Deprivation Therapy (ADT) or hormonal therapy is one of the methods to treat~     intermediate risk prostate cancer. This therapy works by reducing the level of testosterone~     and stopping them from affecting your cancer. The ADT used in this study is known as~     Degarelix. Degarelix is an approved medication that reduces the body's production of~     testosterone; this medication is usually given to all men with intermediate risk prostate~     cancer getting external radiation.~      This study is a randomized study to find out whether combining stereotactic (also known as~     precision) radiation to the prostate cancer combined with a short course of Degarelix will~     result in a greater likelihood of killing the cancer in the prostate compared to stereotactic~     radiation therapy given alone. It has been shown that the combination of radiation with~     medications that interfere with testosterone production and its effects makes prostate cancer~     cells more sensitive to the radiation.~   "
38969|NCT03056625|"~     Vitamin A deficiency (VAD) remains a public health problem that occurs in children and women.~     WHO estimates that 190 million preschool age children (under five years of age) and 19.1~     million pregnant women have inadequate concentrations of retinol . VAD may increase risk of~     morbidity and mortality during childhood, pregnancy and postpartum period . In developing~     countries, vitamin A status in lactating women is not optimal. Even in the United States,~     vitamin A status of low income pregnant women is marginal. Therefore, women of reproductive~     age are at risk of vitamin A depletion which compromises the vitamin A status of breastfed~     infants. Vitamin A is transferred to milk from both retinol binding protein bound and~     chylomicron associated vitamin A carriers. Because of teratogenicity of vitamin A, the~     transfer of vitamin A from pregnant mother to the fetus is carefully controlled. This results~     in all infants born with very low stores of vitamin A . Therefore human milk is still the~     best vitamin A source for infants. The concentration of vitamin A in breast milk is highest~     in the first 21 days postpartum (colostrum in the first 4-6 days and transitional milk in the~     next 7-21 days). Breast milk vitamin A concentrations and an infant's vitamin A status are~     based on maternal dietary intake. Breast milk retinol concentrations are a useful tool and a~     unique indicator for lactating women and represents extrapolations of vitamin A status of~     breastfed infant.~      In high risk vitamin A deficiency areas, prior recommendation for lactating women was to give~     two doses of 200,000 IU vitamin A within 6 weeks post-delivery . However, the lack of impact~     evidence of this regimen led to the WHO's withdrawal of such recommendation as a public~     health policy .~      Food-based intervention has been regarded as a sustainable approach to improve population~     vitamin A status. Most recently, vitamin A-depleted sows fed high-provitamin A carotenoid~     maize resulted in significant increase in liver stores in nursing piglets and significant~     higher milk retinol concentrations than sows fed white maize that given a high-dose vitamin A~     supplement .~      Previous efforts to fortify staples or common vehicles with vitamin A offer promising~     solution to prevention of vitamin A deficiency in vulnerable population . Food fortified with~     vitamin A has potentials to improve women's vitamin A status and to increase the vitamin A~     concentrations of breast milk . Rice as the most important staple food in Thailand,~     represents the culture of consumption and lifestyle of Thai people . Recent study in Thai~     school children fed with extruded rice grains fortified with zinc, iron and vitamin A every~     weekday for 2 months, significantly increased liver stores of vitamin A, as assessed with a~     stable isotope technique . Likewise, fortification of rice with vitamin A may also benefit~     mothers during lactation.~      The outcomes of this study will be useful to guide the promotion of food-based strategies to~     improve vitamin A status of mother and infant during lactation.~   "
38970|NCT03056612|"~     The aim of this study is to assess prospectively the critical period prior to the development~     of Acute-on-Chronic Liver Failure (ACLF) (1), to uncover mechanistic and pathophysiological~     processes associated with the development and clinical course of ACLF (2) and to identify the~     precipitating events of ACLF (3).~   "
38971|NCT03056599|"~     This is a feasibility study in patients with localized or metastatic soft tissue sarcoma~     undergoing surgery to determine how sarcoma in situ responds to injected microdoses of~     anti-cancer therapeutics.~   "
38972|NCT03056586|"~     Genital prolapse is a common complain. 30-40% of women will complain of uterine prolapse or~     cystocele or rectocele, or mixed. About half of them will require surgical repair for the~     prolapse, with or without hysterectomy. Of these patients about 30-40% will have recurrence~     of the prolapse, which in some cases requires second operation.~      In this study the investigators want to investigate whether a vaginal pessary inserting in~     the end of the primary surgery, for 4 weeks, will reduce the recurrence rate.~   "
38973|NCT03056573|"~     Expand the indication of the Portico TF Delivery System and obtain approval of the~     Alternative Access Delivery System~   "
38974|NCT03056560|"~     This study will evaluate an innovative video bystander program, which has the potential to be~     implemented broadly and cost-effectively across college campuses. Half of the participants~     will receive the video bystander program, and the other half will not.~   "
38975|NCT03056547|"~     To explore biological mechanisms in human model of induced dyspnea, in order to remove the~     source of dyspnoea, to modify cerebral impact and to allow the development of targeted~     therapies.~   "
38976|NCT03056534|"~     R3 Delta Post-Approval Study U.S.~   "
38977|NCT03056521|"~     Patients are randomized into 2 groups. The intervention group which receives preoperative~     counseling about pain and a control group which does not receive this counseling.~      The patients are followed up looking at pain scores and pain experience and satisfaction with~     pain management for 2 days post operative.~   "
38978|NCT03056508|"~     This study will explore the impact of an exercise and nutrition (EX+NUTR) , relative to~     exercise alone (EX) intervention, on brain structure and function as well as blood biomarkers~     in older adults with subjective cognitive decline (SCD) and vascular risk factors. The~     overall hypotheses are that a combined EX+NUTR, relative to EX, intervention will evoke more~     positive changes in brain structure (e.g. hippocampal volume), neural activity (e.g. task~     associated functional activations monitored through fMRI), and cognitive performance. These~     changes will be associated with an improved metabolic profile, reductions in inflammatory~     cytokines and oxidative burden, and greater intervention compliance.~   "
38979|NCT03056495|"~     This Clinical Trial is an open, non-randomized Phase Ib study to determine the maximal~     tolerable dose (MTD) of Vorinostat in Alzheimer disease (AD) patients between (including) 55~     and 90 years with mild symptoms. The MTD in this study is defined as the dose that leads to~     maximum toxicity with Common Toxicity Criteria (CTC) grade 1 symptoms.The safety and~     tolerability of Vorinostat in this group of study participants should be tested.~   "
38980|NCT03056482|"~     Cannabis Hyperemesis Syndrome (CHS) has become a well-documented syndrome since 2004 and is~     expected to increase in prevalence with continuing liberalization of marijuana and~     recognition of the disease. Regardless of whether the association with heavy cannabis use is~     recognized, there is well-documented resistance to traditional anti-emetic treatment. Given~     promising reports of the use of intravenous haloperidol, a randomized controlled trial~     comparing it to the commonly administered anti-emetic ondansetron will contribute to the~     management of CHS~   "
38981|NCT03056469|"~     This study investigates if integration of patient-reported outcomes in the follow-up of~     patients with newly diagnosed, not curable, chronic hematological cancer changes the number~     and kind of supportive care interventions. Furthermore, this study investigates if the~     patients feel that they are more involved in a positive way when patient-reported outcomes~     are integrated in the follow-up of their cancer.~   "
38982|NCT03056456|"~     The study will be conducted in participants with type 1 diabetes mellitus to investigate how~     the human body processes LY900014, a new blood sugar lowering insulin, and its effect on~     blood sugar levels when it is delivered via an insulin pump. Side effects and tolerability~     will be documented. The study will last about 4 to 11 weeks for each participant.~   "
38983|NCT03056443|"~     The study aimed to examine the effect of Continuous Positive Airway Pressure (CPAP)~     initiation for newly diagnosed obstructive sleep apnea (OSA) in hospitalized heart failure~     patients on reducing 30-day hospital readmission rate through a clinical trial.~   "
38984|NCT03056430|"~     The purpose of this study is to determine whether intensive slackline training improves~     spatial orientation abilities, balancing skills and causes neuroplasticity in related brain~     cortical regions.~   "
38985|NCT03056417|"~     The current project will use the Complete Health Improvement Program (CHIP) as an~     intervention for patients with chronic pain. CHIP is a nationally recognized program that~     encourages a diet of whole plant-based foods, moderate exercise, stress reduction, and social~     support. Patients with chronic pain who enroll in CHIP classes will be monitored and compared~     to patients with chronic pain who are not enrolled in CHIP classes. It is hypothesized that~     patients who complete CHIP will have increased telomerase activity and longer relative~     telomere length at follow-up when compared to those who do not enroll in the program.~     Chromosomes consist of DNA that contains the genetic makeup of an individual; and telomeres~     are the caps on these chromosomes that protect them from damage. Telomere shortening occurs~     normally with aging and once they are too short to replicate cellular death occurs.~     Telomerase is a ribonucleic protein that counterbalances this shortening by extending the~     ends of chromosomes. Research has shown that patients with chronic pain may have shorter~     telomeres relative to others of the same age. This study will investigate this association~     further.~   "
38986|NCT03056404|"~     This study aims at identifying bird proteins useful for diagnostic tests to determine the~     cause of Bird Fancier's Lung (BFL).~   "
38987|NCT03056391|"~     Acute kidney injury is a common complication of severe Plasmodium knowlesi malaria, and an~     important contributor to mortality.~      The exact pathogenic mechanisms of AKI in knowlesi malaria are not known, however it is~     hypothesised that haemolysis of red blood cells and subsequent release of cell-free~     haemoglobin leads to oxidative stress and lipid peroxidation in the renal tubules.~      A novel mechanism of paracetamol was recently demonstrated, showing that paracetamol acts as~     a potent inhibitor of hemoprotein-catalyzed lipid peroxidation. In a proof of concept trial,~     paracetamol at therapeutic levels was shown to significantly decrease oxidative kidney injury~     and improve renal function by inhibiting the hemoprotein-catalyzed lipid peroxidation in a~     rat model of rhabdomyolysis-induced renal injury.~      The investigators hypothesize that this novel inhibitory mechanism of paracetamol may provide~     renal protection in adults with knowlesi malaria by reducing the hemoprotein-induced lipid~     peroxidation that occurs in haemolytic conditions. As there is currently no consensus that~     exists concerning adequate medical treatment for severe malaria complicated by intravascular~     haemolysis and AKI, the potential application of paracetamol would be of benefit, especially~     as it is safe and widely available.~   "
38988|NCT03056378|"~     The purpose of the study is to determine the safety of pooled red blood cells (RBCs) compared~     to standard leukoreduced RBC products stored in additive solution. The primary objective is~     to determine if there is no significant difference in transfusion associated adverse events~     in POOLED-RBCs compared to standard RBC product groups. Secondarily to determine if there are~     no significant differences in new antibody and new positive direct antiglobulin test (DAT)~     formation in the POOLED-RBCs compared to standard RBC product groups.~   "
38989|NCT03056365|"~     The SAMBA study aims to assess the safety and cost comparison of the management of outpatient~     alcohol detoxification, between an advanced nurse protocol on the one hand (experimental~     group), and a GP-based treatment on the other hand (standard-of-care group).~      In the advanced nurse (AN) group, nurses manage alcohol detox using a predefined protocol~     based on both the Cushman and CIWA-Ar scales. Depending on the Cushman and CIWA-Ar scores,~     which are calculated at every consultation, advanced nurse can adjust the diazepam dosing. In~     case of any serious adverse event or uncontrolled withdrawal complication, an addiction~     specialist stands in back-up and can be appealed to decide whether the outpatient detox can~     be continued or whether the patient has to be hospitalized. In the GP group, GPs can manage~     patients as they wish.~   "
38990|NCT03056352|"~     Post-traumatic headache is common. We are determining short and longer-term outcomes among~     patients treated for post-traumatic headache with IV metoclopramide.~   "
38991|NCT03056339|"~     The goal of this clinical research study is to learn if giving genetically changed immune~     cells, called CAR-NK cells, after chemotherapy will improve the disease in stem cell~     transplant patients with relapsed (has returned) and/or refractory (has not responded to~     treatment) B-cell lymphoma or leukemia. Also, researchers want to find the highest tolerable~     dose of CAR-NK cells to give to patients with relapsed or refractory B-cell lymphoma or~     leukemia. The safety of this treatment will also be studied.~      This is an investigational study. The making of and infusion of genetically changed NK cells~     and the drug AP1903 (if you receive it, explained below) are not FDA approved or commercially~     available for use in this type of disease. They are currently being used for research~     purposes only. The chemotherapy drugs in this study (fludarabine, cyclophosphamide, and~     mesna) are commercially available and FDA approved.~      Up to 36 patients will take part in this study. All will be enrolled at MD Anderson.~   "
38992|NCT03056326|"~     Human Neutrophil Elastase (HNE) plays a pivotal role in innate immunity and in neutrophilic~     lung inflammation that characterized many diseases. CHF 6333 is a potent and 24h-durable~     inhibitor of HNE, developed as Dry Powder Inhaler (DPI) formulation. This study is designed~     to investigate the tolerability, safety and pharmacokinetics of inhaled CHF6333 DPI in~     healthy male subjects.~      The study will comprise two parts:~      Part 1 will consist of two alternated cohorts of healthy male subjects to assess the safety,~     tolerability and pharmacokinetics of Single Ascending Dose (SAD) of CHF6333.~      Part 2 will consist of four sequential cohorts of healthy male subjects to assess the safety,~     tolerability and pharmacokinetics of Multiple Ascending Dose (MAD) of CHF6333~   "
38993|NCT03056313|"~     The duration of labor is decisive for maternal and fetal health. Poor progression often~     results in tired mothers, bad experience, delivery complications and a demand for cesarean~     section in next pregnancy. Proactive support of labor is a method originally from the~     Netherlands.~      The main idea is to define start of active labor earlier than the traditional 3-4 cm opening~     of the cervix and regular contractions to be cervix < 0.5 cm in length, and 1 cm opening and~     painful contractions. From this point, it is expected to be a progress of 1cm/hour opening of~     cervix. If not, progress is supported by amniotomy or stimulation of contractions.~      This method is embraced by several clinics with great enthusiasm. However, there are no~     randomized controlled trials to prove that this method is better than others.~   "
38994|NCT03056300|"~     The primary objective of this trial is to demonstrate the effectiveness of the powered~     vascular stapler for transection of the pulmonary artery (PA) and pulmonary vein (PV) during~     Video-Assisted Thoracoscopic Lobectomy.~   "
38995|NCT03056287|"~     This project will assess the effects of aerobic exercise training (AET), repetitive~     transcranial magnetic stimulation (rTMS) or their combination on depressive severity as well~     as locomotor function in persons with post-stroke depression (PSD). Both AET and rTMS are~     established stand-alone treatments for non-stroke related depression, though neither has been~     adequately studied post-stroke. Furthermore, substantive research indicates that AET improves~     post-stroke locomotor function, thus offering a novel approach for treating PSD as well as an~     established vehicle to study the effects of PSD on response to rehabilitation.~      The purpose of this project is to determine the impact of AET, rTMS and their combination~     (AET+rTMS) treatments on post-stroke depressive symptoms and locomotor function so as to~     guide the development of a future clinical trial. A total of 40 depressed post-stroke~     subjects will be randomly assigned to one of four groups 1) AET; 2) rTMS; 3) combined AET and~     rTMS (AET+rTMS) or 4) control (sham rTMS) group (n=10 per condition; equally distributed with~     mild and moderate MDD). Further, an additional 10 non-depressed post-stroke subjects will~     complete 8 weeks of AET so as to allow us to determine the effects of PSD on response to~     training (Aim 2). Training (AET, rTMS and AET+rTMS) will take place over an 8-week period,~     three times per week on non-consecutive days. Measures of depression (HRSD17) as well as~     self-selected walking speed (SSWS) will be performed prior to the initial treatment session~     of each week as well as 8 weeks following cessation of treatment. Additional measures of~     locomotor function (walking endurance and amount of daily community stepping) will be~     assessed prior to training (pre), following 4 weeks of training (mid), upon completion of 8~     weeks of training (post) as well as 8 weeks following cessation of training (follow-up),~     allowing determination of the efficacy (and persistence) of training on these outcomes.~   "
38996|NCT03056274|"~     This is a pilot study aimed at comparing the effect of metformin versus ursodeoxycholic acid~     in women with intrahepatic cholestasis in pregnancy. The study will be conducted in three NHS~     hospital sites, over an 18 month period.~   "
38997|NCT03056261|"~     Sixty neonates and infants will be enrolled and randomised into two groups of n=30 each . For~     their surgical procedures, one group general (GA) anaesthesia the second group will receive a~     combined general and epidural anaesthesia (CGEA).~      Anaesthetic technique:~      Patients in the GA group will be induced with intravenous propofol (2-4 mg.kg-1) and fentanyl~     (2-4 µg.kg-1) and will receive rocuronium bromide (0.5 mg.kg-1) to facilitate endotracheal~     intubation. Anaesthesia will be maintained with sevoflurane (2-3%) in an air/oxygen mixture~     as well as intravenous fentanyl as required.~      In the (CGEA) 0.5 ml.kg-1 of 0.25% bupivacaine will be injected into the epidural catheter,~     followed by a continuous infusion of 0.1% bupivacaine at a rate of 0.2 mg.kg-1.hr-1 for up to~     48 hours postoperatively. Assessment of anaesthetic efficacy will be measured Intraoperative~     care vital signs. And will continuously be monitored with a Datex AS/3 (Engestrom®, Helsinki,~     Finland) monitor.~      The use of antibiotic prophylaxis will be determined by the degree of bowel contamination~     during surgery, with the commonest regimen consisting of penicillin, gentamicin and~     metronidazole will be administered. Antibiotics will be continued for 36-48 hours~     postoperatively to prevent infection arising from the disturbed bowel flora.~      Postoperative care, following surgery, will be conducted. The feeding volume will be~     increased in steps as long as the volume of regurgitated fluid will be less than 20% of the~     administered breast milk or formula volume. Full feeding will define as oral tolerance of at~     least 80% of daily maintenance volume. In cases of abdominal distension or vomiting, feeding~     will withheld until symptom resolution. The nasogastric tube will be removed on bowel~     function restoration The CRIES score will be use to assess the severity and duration of~     postoperative pain during the patients' NICU stay. If the CRIES score is ≥4, fentanyl will be~     continuously intravenously infused in both study group. Fentanyl will be also administered to~     CGEA patients who experienced pain despite a continuous epidural infusion at 1-5 µg.kg-1.h-1.~     The amount of fentanyl required for adequate postoperative pain relief will be recorded in~     both groups.~   "
38998|NCT03056248|"~     A growing body of pre-clinical evidence suggests that glycogen synthase kinase 3β (GSKβ) is~     implicated in the development and progression of acute kidney injury (AKI). Lithium is a~     naturally occurring standard inhibitor of GSKβ. The purpose of this study is to examined if~     low dose lithium carbonate is able to reduce the incidence of AKI in patients undergoing~     cardiac surgery who are placed on cardiopulmonary bypass during surgery. We hypothesize that~     low dose lithium might reduce the incidence and duration of AKI in patients undergoing~     cardiac surgery who are on cardiopulmonary bypass.~   "
38999|NCT03056235|"~     The study is designed to evaluate the efficacy of two formulations of a cross-linked~     tropoelastin matrix given the product codes ELAPR002f and ELAPR002g (collectively referred to~     as ELAPR or ELAPR002) for the treatment of rolling atrophic acne scars when administered as~     intradermal implants.~   "
39000|NCT03056222|"~     The aim of the study is to compare the acute procedure and safety outcomes as well as long~     term clinical outcomes of 2 groups of patients treated with the HeartLight® Endoscopically~     Guided Laser Ablation (EGLA) or a commercially available Contact Force Sensing Irrigated~     Radiofrequency (RF) Ablation Catheter plus, at the operator's discretion, 3D~     Electroanatomical Mapping (EAM) for the treatment of Paroxysmal Atrial Fibrillation (PAF).~   "
39001|NCT03056209|"~     The purpose of this First In Human study is to investigate the safety and tolerability of~     KL1333 after a single oral dose and to investigate the pharmacokinetic characteristics of~     KL1333 after a single oral dose.~   "
39002|NCT03056196|"~     Introduction~      Undiagnosed deep vein thrombosis (DVT) can lead to significant morbidity and mortality,~     including death from DVT-associated massive pulmonary embolism (PE). While several validated~     clinical prediction rules, blood test and imaging modalities exist to investigate a potential~     DVT, there is currently a lack of rapid, accessible and reliable methods to exclude the~     possibility of DVT without resorting to formal venous duplex scanning.~      Currently, the use in the ED of a validated clinical prediction rule combined with~     high-sensitivity D-dimer test has a poor predictive value, as 75-90% of patients suspected of~     DVT have a negative formal venous duplex scan.~      Compression bedside ultrasound has however recently been shown to be a safe, rapid and~     accurate method for the diagnosis of proximal DVT in the emergency department with a high~     sensitivity and specificity (combined sensitivity and specificity of 96.1% and 96.8%,~     respectively1).~      Research Question~      In the present study, the investigators will primarily assess whether two-site compression~     POCUS combined with a negative age-adjusted D-dimer test can accurately rule out DVT in ED~     patients regardless of the Wells criteria.~      Methods~      This is a single-center, prospective, observational study carried out over one year in the~     Emergency Department of the Jewish General Hospital in Montreal, Quebec. The investigators~     aim to enroll a convenience sample of 475 patients aged 18 years and older presenting to the~     ED with symptoms suggestive of a DVT. All enrolled patients will receive the standard of care~     required for a lower leg DVT presentation. After calculating Patients DVT risk using modified~     wells criteria, all patients will undergo POCUS for DVT followed by a D-dimer test. Based on~     their results, patients will either undergo formal duplex scanning, or will be discharged~     without further testing and receive a three-month phone follow-up.~      A true negative lower leg DVT will be defined as follows:~        1. Negative follow-up phone questionnaire for patients who were sent home with no formal~          duplex venous scanning.~        2. Negative formal duplex venous scanning for patients who were deemed likely to have lower~          leg DVT using the Wells score, with a negative D-dimer and POCUS~      Age-adjusted DVT was added to account for below knee DVT and avoid the need for patients to~     return for fellow up duplex study in 1 week.~      To estimate our technique's sensitivity with a 4% margin of error with 95% confidence~     intervals, 92 confirmed DVT patients are needed. The investigators expect to recruit a total~     475 patients within one-year period at the JGH (95 DVT-positive patients and 380 DVT-negative~     patients).~      Impact~      The use of compression bedside ultrasound with a negative age-adjusted D-dimer test to rule~     out DVT in the ED may accelerate the decision regarding patient disposition and significantly~     decrease the length of patient stay in the ED. In addition, it may help avoid unnecessary~     medical interventions and diagnostic tests, thus representing potential quality of care and~     cost-saving improvements as well.~   "
39003|NCT03056183|"~     Aim 1: To collect data on a Depression Care Transition (DCT) program's association with~     self-care behaviors as measured by medication adherence and clinic visit attendance, after~     discharge. Hypothesis 1: Compared with usual care, patients who receive the DCT intervention~     will have significantly greater medication adherence and clinic visit attendance, at 30, 90,~     and 365 days after discharge.~      Aim 2: To collect data on DCT's association with clinical/health outcomes as measured by~     depression severity, functional status, and overall physical and mental health, after~     discharge. Hypothesis 2: Compared with usual care, patients who receive the DCT intervention~     will have significantly larger improvements in depression severity, functional status, and~     overall physical & mental health at 30, 90, and 365 days after discharge.~      Aim 3: To collect data on DCT's association with utilization outcomes as measured by~     readmissions, length of subsequent hospital stays, and cost of care, after discharge.~     Hypothesis 3: Compared with usual care, patients who receive the DCT intervention will have~     significantly lower hospital readmissions, shortened length of subsequent hospital stays and~     lower cost of care, at 30, 90, and 365 days of discharge.~      Leading the research team are a psychiatrist (Dr. IsHak - PI) and a hospitalist (Dr. Nuckols~     - Co-I) with an advanced and well-established track record of health services~     research/scholarship in the fields of depression, outcome measurement, and economic~     implications of improving the quality and safety of health care.~   "
39004|NCT03056170|"~     tDCS is a technique emerging as a prospective therapy for neurologic, psychiatric and~     addictive disorders. Specifically, fronto-temporal tDCS, with anodal stimulation over the~     left dorsolateral prefrontal cortex (DLPFC) and cathodal stimulation over the left~     temporo-parietal junction (TPJ), has been reported to reduce treatment-resistant auditory~     hallucinations (AH), negative symptoms and insight of the illness in schizophrenia. However,~     despite an increasing use in clinical settings, tDCS suffers from limitations, especially~     regarding the strength and the duration of therapeutic effects.~      Some imaging reports suggest that tDCS effects are not restricted to the brain areas located~     under the electrodes, but spread through distributed cortical networks functionally connected~     with the targets and reach subcortical areas. Overall, these studies suggest that tDCS~     modulates functional connectivity within and across resting-state networks and brain~     activity. However, these effects are currently described at different levels depending on the~     imaging technique used. Moreover, the majority of studies have focused on motor cortex~     stimulation, while the specific effects of fronto-temporal tDCS are scarce. Finally, effects~     of the stimulation applied online are rarely inspected.~      According to the therapeutic effects of fronto-temporal tDCS on schizophrenia and the~     dopaminergic pathophysiological hypothesis of schizophrenia, the effect of fronto-temporal~     tDCS on dopaminergic transmission is of major interest. As the cortex is densely connected~     with basal ganglia areas, tDCS effects are probably capable to reach subcortical dopaminergic~     areas. Indeed, recent fMRI studies highlighted subcortical effects of tDCS applied at the~     cortical level including modulations of cortico-striatal and thalamo-cortical functional~     connectivity. In addition, some studies suggest that cortical stimulation by other~     approaches, such as transcranial magnetic stimulation (rTMS) modulates dopaminergic~     transmission. However, tDCS effects on dopaminergic transmission have been investigated only~     indirectly.~      Finally, information about biological effects of tDCS is scattered and creating a coherent~     ensemble is a mandatory and critical step to understand the mechanisms of action of tDCS.~      According to the hypothesis that fronto-temporal tDCS modulates brain activity, connectivity~     and dopaminergic transmission, the aim of this project is to reveal the combined~     neurobiological impact of an online single session of fronto-temporal tDCS in a unique~     experiment by developing a simultaneous multimodal imaging approach (PET-MRI). The online~     implementation of the stimulation will allow deciphering changes induced during and after~     stimulation. As a first step before investigating patients with schizophrenia, healthy~     subjects will be involved in the present study.~      The distributed changes will be explored at rest through:~        -  Spontaneous functional connectivity assessed by functional magnetic resonance imagery~          (fMRI).~        -  Brain activity assessed by cerebral blood flow quantitatively and directly measured by~          arterial spin labelling (ASL).~        -  Connectivity assessed by diffusion tensor imaging (DTI).~        -  Specific and localized dopaminergic transmission evaluated by positron emission~          tomography (PET) using dopaminergic D2 subtype receptor availability via [11C]raclopride~          binding.~      The pioneering aspects of the project are to use an innovative simultaneous multimodal~     imaging system, adopt the tDCS montage used in our validated therapeutic context and apply~     tDCS online. We expect that our unique approach will provide an imaging biomarker essential~     to improve our understanding of:~        1. the normal brain and further deficient mechanisms underlying schizophrenia as well as~          neurological disorders.~        2. neurobiological effects of tDCS in order to:~             -  Bring key element of the proof of concept of tDCS~             -  Optimize tDCS in a therapeutic context~             -  Suggest a marker of the therapeutic response~   "
39016|NCT03056014|"~     Dietary supplementation with antioxidant vitamins, such as Vitamin C and Vitamin E, reduces~     malformation rates in embryos of diabetic animals. However, human trials exploring the~     benefits of these antioxidant vitamins have produced unsatisfactory results in trials~     designed to alleviating diabetic retinopathy, cardiovascular disease, and preeclampsia in~     pregnancies. The investigators hypothesize that more potent, and better-targeted~     antioxidants, such as N-acetylcysteine (NAC) and Polyunsaturated Fatty Acids(PUFA), will be~     successful in preventing birth defects in the offspring of women with diabetes.~   "
39017|NCT03056001|"~     The purpose of this study is to evaluate the safety, tolerability and efficacy of doxorubicin~     in combination with pembrolizumab in subjects with metastatic or unresectable soft tissue~     sarcoma. Based on previous studies, pembrolizumab may be an effective study treatment.~   "
39005|NCT03056157|"~     The aim of this study is to determine the efficacy of Adaptive Disclosure for Moral Injury~     and Loss (AD-MIL), a combat-specific psychotherapy for war-related PTSD stemming from Moral~     Injury (MI) and traumatic loss (TL) with Iraq and Afghanistan War Veterans with PTSD. AD-MIL~     will be compared to Present Centered Therapy (PCT). AD-MIL is a modified version of Adaptive~     Disclosure (AD), which has been modified and extended to solely treat MI and TL by targeting~     psychological and behavioral obstacles to occupational, relationship, and family functioning,~     as well as quality of life. PCT is a manualized evidenced-based PTSD treatment used in~     several large-scale PTSD trials. The primary end-point is psychosocial functioning~     (improvements in social, educational and occupational functions and improvements in quality~     of life). Secondary end-points include PTSD, depression, and shame and guilt. The~     investigators will also explore the impact of AD-MIL on anger and aggressive behaviors,~     suicidal ideation, and alcohol abuse.~   "
39006|NCT03056144|"~     Spinal muscular atrophy (SMA) are one of the common physical disabilities in childhood. For~     SMA, progressive muscle weakness and early fatigue hamper the mobility of the sufferers.~     Osteopenia is common for this population group due to poor bone growth and muscle disuse. As~     a result, non-traumatic related fractures and bone pain are common. Recently, whole body~     vibration therapy (WBVT) has been proven to improve bone health and muscle function in~     healthy adults and post-menopausal women. Among the limited studies on the WBVT for children~     with muscular dystrophies, promising results have been shown on gross motor function,~     balance, and muscle strength and the WBVT appears to be safe for children with SMA.~      The present pilot study is designed to investigate if WBVT is safe and feasible for~     individuals with SMA and if WBVT can improve muscle function, functional abilities, postural~     control and bone mineral density in children with SMA. Convenience samples of 10 individuals~     with SMA type III will be recruited. The participants will receive the WBVT of 25 Hertz and a~     peak-to-peak amplitude of 4mm for a session of about 18 minutes, 3 days per week for 4 weeks.~     Assessment will be performed at the baseline and the completion of the intervention to~     examine the muscle function, functional abilities, postural control and bone mineral density~     of the participants.~      It is anticipated that the outcomes of this pilot study for SMA may show if this intervention~     is safe, feasible and beneficial for children with SMA type III regarding to muscle function,~     functional abilities, postural control and bone mineral content and if there may be any~     related practical issues of this intervention to this population group. The outcomes also~     provide research evidence to clinicians if this intervention should be recommended to~     individuals of similar problems.~   "
39007|NCT03056131|"~     Tension Type Headache (TTH) is a frecuent type of headache disorder (about 1 person in 5~     worldwide). Individuals with TTH typically present pericraneal tenderness and an increased~     cervical muscle tone.~      The most common treatment in primary care consists mainly on analgesic medication. However,~     different techniques of manual therapy have been shown to be effective in the treatment of~     these patients. Diacutaneous fibrolysis shows clinical benefits in relieving symptoms of~     tension type headache, but there is no scientific evidence that analyzes this effects.~      The hypothesis of this study was that adding treatment with diacutaneous fibrolysis to the~     usual conservative treatment has beneficial effects on different variables of the headache.~      The aim of the study was to assess the effect of diacutaneous fibrolisis on intensity,~     frequency, duration of headache and cervical function in patients with tension type headache.~      A randomized controlled clinical trial has been designed to evaluate the effectiveness of~     diacutaneous fibrolysis technique compared to usual general practicioner care in patientes~     with tension type headache.~      The study protocol has been approved by the Clinical Research Ethics Committee from the~     Aragon Community and all patients provided written consent.~      Eighty-two people with clinical diagnosis of TTH were randomized into a intervention group or~     a control group. Intervention group received three sessions of Diacutaneous Fibrolysis, while~     control group was advised to maintain their usual pharmacologic treatment. Pain intensity~     (VAS), frecuency, location, cervical range of motion, head forward position and pressure pain~     thresholds (PPTs) were measured at baseline, postintervention, and 1 month follow-up after~     treatment. The Spanish version of the HIT-6 Questionnaire was used to measure~     disability/function at baseline and follow-up.~   "
39008|NCT03056118|"~     Investigators try to assess the safety of 6-months or 12-months maintenance of dual~     antiplatelet therapy (DAPT, aspirin + clopidogrel) in patients undergoing percutaneous~     coronary intervention using the Zotarolimus-eluting, Resolute Integrity™ stent (Medtronic~     Vascular Inc, Santa Rosa, CA) or the BioMatrix™ stent (Biosensors. Singapore).~   "
39009|NCT03056105|"~     The purpose of this study was to examine how participation in a 1 month intensive Insight~     (vipassana) Meditation retreat (a) affects biological markers of cellular aging, social~     affiliation, and inflammation, which are important for physical health, longevity, and~     behavior, and (b) to relate observed biological changes to baseline levels and changes in~     psychological traits, which may underlie improvements in personal adaptive functioning.~   "
39010|NCT03056092|"~     Objective: To determine the association between baseline aqueous cytokine levels and~     treatment intervals for patients under a variable dosing regimen with intravitreal~     ranibizumab in patients with neovascular age-related macular degeneration (nAMD), macular~     edema secondary to retinal vein occlusion (RVO) and diabetic macular edema (DME).~      Methods: A prospective, single-centre study will be performed containing 3 sub-studies~     according to each study population: nAMD, macular edema secondary to RVO and DME. Inclusion~     criteria are: patients followed at St. Michael's Hospital with the diagnosis of nAMD, macular~     edema secondary to RVO or DME. Patients will be excluded if visual acuity is worse than~     counting fingers, with macular pathologies causing any structural changes to the retina, have~     received anti-VEGF injections or photocoagulation therapy 6 months prior to study,~     intraocular surgery 3 months prior to study, any history of vitreoretinal surgery or ocular~     inflammation in the study eye, use of systemic or topical anti-inflammatory or steroids,~     patients on dialysis for renal failure, allergy to the study drug or fluorescein, <18 years~     old, women who are pregnant. All patients will be treated with ranibizumab intravitreal~     injections on a variable dosing regimen: Patients with DME will be examined monthly and~     receive mandatory injection for the first three months (baseline, weeks 4 and 8). Afterwards,~     they will continue to be seen monthly and the need for new injections will be decided upon~     the clinical findings at each visit. An anterior chamber (AC) tap will be done if an~     injection is required at the visit. Patients with nAMD and RVO will be examined monthly and~     receive mandatory injection for the first three months. From weeks 12 until 72 (month 18),~     the visits will be scheduled at increasing 2-weeks intervals based on the stability of the~     ocular condition and response to treatment. At each visit, an injection and AC tap will be~     performed. The maximum interval in between injections is 12 weeks. If the disease becomes~     unstable, the interval in between injections is shortened and, once it stabilizes, the~     treatment frequency is extended again. In all patients, baseline aqueous humour specimens~     will be obtained prior to the first ranibizumab intravitreal injection and follow-up samples~     will be taken immediately prior to subsequent injections based on the treatment regimens for~     cytokine analysis in the end of the follow-up.~   "
39011|NCT03056079|"~     Objective: To determine the association between baseline aqueous cytokine levels and~     treatment intervals for patients under a variable dosing regimen with intravitreal~     aflibercept in patients with neovascular age-related macular degeneration (nAMD), macular~     edema secondary to retinal vein occlusion (RVO) and diabetic macular edema (DME).~      Methods: A prospective, single-centre study will be performed containing 3 sub-studies~     according to each study population: nAMD, macular edema secondary to RVO and DME. Inclusion~     criteria are: patients followed at St. Michael's Hospital with the diagnosis of nAMD, macular~     edema secondary to RVO or DME. Patients will be excluded if visual acuity is worse than~     counting fingers, with macular pathologies causing any structural changes to the retina, have~     received anti-VEGF injections or photocoagulation therapy 6 months prior to study,~     intraocular surgery 3 months prior to study, any history of vitreoretinal surgery or ocular~     inflammation in the study eye, use of systemic or topical anti-inflammatory or steroids,~     patients on dialysis for renal failure, allergy to the study drug or fluorescein, <18 years~     old, women who are pregnant. All patients will be treated with aflibercept intravitreal~     injections on a variable dosing regimen: Patients with DME will be examined monthly and~     receive mandatory injection for the first three months (baseline, weeks 4 and 8). Afterwards,~     they will continue to be seen monthly and the need for new injections will be decided upon~     the clinical findings at each visit. An anterior chamber (AC) tap will be done if an~     injection is required at the visit. Patients with nAMD and RVO will be examined monthly and~     receive mandatory injection for the first three months. From weeks 12 until 72 (month 18),~     the visits will be scheduled at increasing 2-weeks intervals based on the stability of the~     ocular condition and response to treatment. At each visit, an injection and AC tap will be~     performed. The maximum interval in between injections is 12 weeks. If the disease becomes~     unstable, the interval in between injections is shortened and, once it stabilizes, the~     treatment frequency is extended again. In all patients, baseline aqueous humour specimens~     will be obtained prior to the first aflibercept intravitreal injection and follow-up samples~     will be taken immediately prior to subsequent injections based on the treatment regimens for~     cytokine analysis in the end of the follow-up.~   "
39018|NCT03055988|"~     The objectives of the study are to explore the effect of treatment with tiotropium +~     olodaterol fixed dose combination (FDC) compared to fluticasone propionate + salmeterol FDC~     on:~        -  reversal of left ventricular diastolic dysfunction assessed with cardiac magnetic~          resonance (CMR) imaging,~        -  measures of arterial stiffness assessed by CMR and pulse wave analysis (PWA),~        -  reduction of hyperinflation assessed with body plethysmography and~        -  post dose spirometry.~   "
39019|NCT03055975|"~     Sampling of accessed root canals with endodontic paper points during treatment and~     immediately pre-obturation of endodontic root canals was carried out.~   "
39020|NCT03055962|"~     Study E2609-J081-014 is a single-center, randomized, double-blind, placebo-controlled study~     conducted to evaluate the safety and tolerability of multiple oral doses of E2609 50~     milligrams (mg), administered once daily for 14 days, in healthy Japanese participants aged~     50 to 85 years.~   "
39021|NCT03055949|"~     The purpose of this study is to determine whether an early rehabilitation program in surgical~     intensive care unit is safe and effective in preventing critical care illness and intensive~     care unit acquired weakness.~   "
39022|NCT03055936|"~     This is a phase I PK study in healthy males.~   "
39023|NCT03055923|"~     This Pilot study evaluates the use of a new device called Inflammacheck and whether it can~     consistently measure hydrogen peroxide levels in exhaled breath condensate. It will also~     assess whether exhaled breath condensate hydrogen peroxide levels as measured by~     Inflammacheck can differentiate people with asthma and COPD from healthy individuals.~   "
39024|NCT03055910|"~     The Fractional Flow Reserve Fax Registry is an investigator-initiated, real-world registry to~     analyze the use of fractional flow reserve (FFR) measurements in clinical practice in cardiac~     catheterization laboratories in Germany. The registry aims to collect the data of 2000~     patients who underwent FFR recordings for clinical reasons. The main outcome parameter is the~     frequency of coronary revascularization following FFR. Secondary outcome parameters include~     the distribution of quantitative FFR results in clinical practice, the influence of~     intracoronary versus intravenous adenosine on the distribution of FFR results, the rate of~     complications as a result of FFR measurements, the average number of FFR wires needed per~     patient. Since the study will include a large number of patients who undergo i.c.~     administration of adenosine and a large number of patients who undergo i.v. administration of~     adenosine, it will be possible to analyze whether the route of adenosine administration is an~     independent predictor of the FFR result.~   "
39025|NCT03055884|"~     The purpose of this study is to investigate whether it is possible to accelerate learning and~     improve associative memory performance in healthy subjects, by (1) applying transcranial~     Direct Current Stimulation (tDCS) during a verbal paired-associate learning task and by (2)~     optimizing the learning method with repeated retrieval practice.~   "
39026|NCT03055871|"~     The purpose of this study is to examine physical activity habit formation in parents and if~     this can increase moderate to vigorous physical activity behavior in their children over six~     months.The Primary Research Question is:~      Does the habit formation condition result in increased moderate-vigorous intensity physical~     activity of the child compared to the control (education) and education + planning conditions~     at six months? Hypothesis: Child physical activity will be higher for the habit formation~     condition in comparison to the more standard physical activity education and planning~     conditions at six months.~   "
39027|NCT03055858|"~     The ADO II AS Study is a single arm, prospective, multicenter, nonrandomized, open-label~     study to characterize the safety and effectiveness of the ADO II AS device in patients with a~     patent ductus arteriosus (PDA). Subjects will be implanted with the ADO II AS device using a~     transcatheter femoral vessel approach under fluoroscopic and echocardiographic guidance.~      To account for subject dropout, up to 50 subjects will be enrolled in this clinical~     investigation. The clinical investigation will be conducted at up to 10 centers in the United~     States.~      Subjects participating in this clinical investigation will be followed for 3 years. The~     expected duration of enrollment is 18 months. The total duration of the clinical~     investigation is expected to be 4.5 years.~   "
39028|NCT03055845|"~     A phase I, randomized, double-blinded, placebo-controlled, single ascending dose study to~     investigate the safety, local tolerability and transformation of nucleus pulposus following~     intradiscal injection of STA363 or placebo in patients with discogenic low back pain.~      15 patients will participate in either of 3 dose groups, each comprising 5 patients:~        -  Group 1: STA363 dose 1 (3 patients) or placebo (2 patients)~        -  Group 2: STA363 dose 2 (3 patients) or placebo (2 patients)~        -  Group 3: STA363 dose 3 (3 patients) or placebo (2 patients)~   "
39029|NCT03055819|"~     The LIFT study will document the first clinical use of the ZiftLift Tissue Anchor in a~     browlift for patients with age-related brow ptosis. It is a single arm, open label~     multicenter study, to evaluate the safety and efficacy of the Zift Lift System. Up to 20~     subjects in up to 3 sites will be enrolled in this study. Data from this trial will be used~     to confirm the device safety and efficacy and provide inputs to further refine the device~     design and procedure technique for future device iterations~   "
39030|NCT03055806|"~     A Phase 2b, 8-week, double-blind, placebo-controlled, parallel group study to evaluate the~     effect of 3 different dose levels of IX-01 on IELT and patient-reported outcome in men with~     lifelong PE.~      Men with self-reported lifelong PE (International Society for Sexual Medicine (ISSM)~     definition) and in stable heterosexual relationship will undergo a 4-week run-in period~     during which they will be asked to attempt intercourse at least 4 times. Men with IELT ≤ 1~     minute on at least 75% of attempts at intercourse during the no-treatment run-in period will~     be randomized for the double-blind phase of the study.~      In the double-blind phase of the study, men will be asked to take study drug 1 to 6 hours~     prior to sexual activity. Men and partners will be asked to attempt intercourse a minimum of~     8 times during the 8 week double-blind study treatment. The patient or partner will record~     the IELT on each occasion by use of a stopwatch.~   "
39057|NCT03055442|"~     Considering the importance assumed by follicular microenvironment for a proper oocyte~     development, this study is a prospective observational clinical trial which aims to evaluate~     whether the embryo blastocyst quality may be affected by different Myo-inositol (MI) and~     D-chiro-inositol (DCI) levels in the follicular fluid (FF) of the aspired oocytes. The study~     includes egg donors and egg receiving couples participating in the oocyte donation program.~     MI/DCI is calculated in FF and related with blastocyst grade.~   "
39031|NCT03055793|"~     The greater efficacy of combination therapy led to the development of fixed combination~     devices which simultaneously carry both glucocorticosteroid and a LABA (eg stable~     combinations of fluticasone-salmeterol, budesonide-formoterol).~      Fixed combinations are easier to use for patients, potentially increasing compliance, and~     ensure that the LABA always accompanied by glycocorticosteroeides1. From the available~     combinations of the combination of budesonide-formoterol can be used both in maintenance~     therapy and for the relief of symptoms due to the rapid onset of action of formoterol~     compared with salmeterol. Both components of budesonide-formoterol combination when~     administered on demand contribute to strengthening protection from severe exacerbations in~     patients receiving combination therapy for maintenance, and enable improvement of asthma~     control at relatively low doses of ICS.~   "
39032|NCT03055780|"~     The aim of this study was to determine the diagnostic accuracy of SURECardio CT-FFR to detect~     functionally significant coronary stenosis.~   "
39033|NCT03055767|"~     The purpose of the research is to examine the outcomes of pediatric patients receiving~     Botulinum toxin type A (Botox ®) for the treatment of migraine. There is limited literature~     on the effectiveness of Botox ® in the treatment of chronic neurological pain in pediatric~     patients, specifically in the treatment of migraines.~   "
39034|NCT03055754|"~     Bariatric surgery procedures have consistently been demonstrated to reduce long-term~     co-morbidities and mortality. Despite its benefits, weight regain is common, usually~     initiating around two years after the initial procedure, the underlying mechanism often being~     an enlargement of the anastomosis diameter for the Roux-en-Y gastric bypass. Although a~     reduction in the anastomosis diameter has been reported in association with endoscopic argon~     plasma coagulation, to our knowledge this therapy has not been formally tested in a~     randomized controlled trial. the objective of this study is to conduct a randomized, parallel~     controlled trial comparing endoscopic argon plasma coagulation to reduce the enlargement of~     the anastomosis diameter for the Roux-en-Y gastric bypass versus control with an initial~     diagnostic endoscopic followed by observation. The investigators hypothesize that the argon~     coagulation arm will achieve greater weight reduction, with a low incidence of adverse~     events.~   "
39035|NCT03055741|"~     The objective of this study is to evaluate the efficacy and safety of DHP1401 in patients~     with mild-moderate Alzheimer's disease treated with donepezil~   "
39036|NCT03055728|"~     The purpose of this study is to determine if the rapid antigen detection test for Group A~     streptococcal pharyngitis diagnosis might yield higher rates of false positive results in~     patients who have been treated for GAS pharyngitis within 28 days of the test.~   "
39037|NCT03055715|"~     The aim of the study is to retrospectively monitor the 'gross tumor volume' (GTV) before~     initiation of radiotherapy and its changes during radiotherapy and to correlate them with~     retrospectively recorded patient data, as well as with prognostic and therapeutic outcome~     after definite radiotherapy of locally advanced NSCLC in stage UICC III.~   "
39038|NCT03055702|"~     A randomized controlled trial of patients with type 2 diabetes mellitus with multiple~     appointments into short message service group and control group. The attendance rate of these~     two groups of patients will be compared.~   "
39039|NCT03055689|"~     This trial will evaluate the efficacy in colon cleansing of a nurse-led educational telephone~     intervention 24-48 hours before a colonoscopy, in selected participants with a previous~     inadequate bowel preparation.~   "
39040|NCT03055676|"~     The aim of this randomized prospective multicenter study is to demonstrate the hypothesis~     that early removal of drain can reduce the incidence of pancreatic fistula and~     intra-abdominal infection after pancreaticoduodenectomy , when compared with later removal of~     drain.~   "
39041|NCT03055663|"~     During spinal anesthesia, sedation is performed using intravenous sedative for the patient's~     comfort and appropriate surgical environment. However, side effects of medications such as~     respiratory depression, hypotension, bradycardia and desaturation cannot be avoided.~     Recently, there have been developed a virtual reality experience equipment and a variety of~     virtual reality programs including visuo-haptic computer technology. There have been clinical~     studies that apply this technology to the pain medicine, sedation and medical education.~     However, no study has been reported for the purpose of replacing sedation during spinal~     anesthesia.~      Therefore, we attempt to evaluate the efficacy and safety of sedation using virtual reality~     meditation program during spinal anesthesia for urologic surgery.~   "
39042|NCT03055637|"~     Evaluation of the incidence of palatal fistula in Furlow double-opposing z-plasty versus~     two-flap palatoplasty for cleft palate repair.~   "
39043|NCT03055624|"~     Investigator-initiated study to evaluate the safety and efficacy of prostate artery~     embolization for the treatment lower urinary tract symptoms in patients with benign prostatic~     hyperplasia~   "
39044|NCT03055611|"~     Elocta (rFVIIIFc) and Alprolix (rFIXFc) are recombinant extended half-life coagulation factor~     products. The purpose of this non-interventional study is to describe the real-world usage~     and effectiveness of Elocta and Alprolix in the prophylactic treatment of haemophilia A and~     B.~   "
39045|NCT03055598|"~     This research study is for participants that have End Stage Renal Disease (ESRD). ESRD is the~     last stage of chronic kidney disease. Anemia is very common in ESRD patients and require~     erythropoiesis-stimulating agents (ESAs) for treatment. Anemia happens when there are not~     enough red blood cells in your body. ESAs work by helping the bone marrow to produce red~     blood cells. There are two ESAs licensed for the treatment of anemia of CKD in the Unites~     States: epoetin alfa and darbopoetin alfa. ESA therapy is considered safe. However, major~     adverse effects should be acknowledged, including an increased risk of death, thromboembolic~     complications, stroke, heart attack, aplastic anemia, tumor progression, and others. To~     minimize risks of these adverse events, careful monitoring of hemoglobin levels, along with~     adjustment of ESA dosing, to maintain the lowest hemoglobin level clinically needed is~     recommended.~      Ferric Citrate, also called Auryxia, is an iron-based phosphate binder that may decrease ESA~     usage while maintaining hemoglobin levels. Phosphate binders are medications used to reduce~     the body's absorption of phosphate. In a prior study, it was seen that some laboratory~     values, such as iron levels, changed positively in response to Auryxia. In this study we want~     to see if using Auryxia will cause a change in laboratory values and lower the use of ESAs in~     ESRD patients.~   "
39046|NCT03055585|"~     This cluster randomised trial will evaluate the efficacy of Wolbachia-infected Aedes aegytpi~     mosquitoes in reducing dengue cases in Yogyakarta City, Indonesia~   "
39047|NCT03055572|"~     Persons with a loss of sense of smell, who agree to participate in this study, will be~     assigned to one of three groups: two groups will have smell training and the third group will~     not do smell training. Participants assigned to one of the smell training groups will be~     asked to smell four different odors in rotation for five minutes two times per day, a total~     of 10 minutes of participation per day, for 12 weeks. One smell training group will be given~     odors made of fragrance oils to use for smell training. The other smell training group will~     be given odors made of essential oils to use. Participants in all groups will continue taking~     all medications and nasal rinses for sinusitis as prescribed by their doctor.~   "
39048|NCT03055559|"~     The haemoglobin level of the patients with iron deficiency should be increased clinical~     relevant after 12 weeks treatment with GlobiFer Forte.~   "
39049|NCT03055546|"~     The aim is to examine whether intranasal oxytocin will influence the individuals' emotion~     regulation ability and related neural mechanisms.~   "
39050|NCT03055533|"~     Headsprout is a commercially available computer-based reading program that teaches children~     fundamental reading skills, including phonics, fluency, and comprehension. The Headsprout~     reading intervention has been shown to be effective with children with various levels of~     reading skills, but it has not been rigorously tested in children with autism spectrum~     disorder (ASD). The purpose of this study is to evaluate the effectiveness of Headsprout in a~     pilot sample of 18 children with ASD and reading delays to serve as a foundation for a~     larger, future randomized clinical trial (RCT).~      Eighteen participants will be included in the study and randomly assigned to one of two~     groups; the first group will immediately receive treatment with the Headsprout reading~     program and the second treatment group will receive treatment after 12 weeks. Treatment~     sessions will occur for one to two hours, two to four days a week, for twelve weeks. The~     participants who do not receive treatment immediately will be asked to come in for reading~     assessments periodically throughout their wait time.~   "
39051|NCT03055520|"~     A randomized placebo-controlled trial of arithmetic training (with the Kumon Method) as an~     errorless learning method for improvement of cognition in schizophrenia. Outpatients were~     included after signing an informed consent. The trial consisted of 48 sessions of arithmetic~     training (twice a week, for 6 months) or placebo (nonspecific recreation, 48 sessions). The~     patients were evaluated with a neuropsychological battery at baseline, after 6 months (end of~     intervention) and after 12 months after baseline. The Positive and Negative Syndrome Scale~     (PANSS) and the Personal and Social Performance scale (PSP) were applied at baseline, after 6~     months (end of intervention) and 12 months after baseline. Primary outcome was the~     performance on three cognitive domains (attention, executive functions and working memory).~   "
39052|NCT03055507|"~     Endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS) is a common procedure in the~     US, with about 250,000 cases performed annually. Currently, there is no consensus,~     evidence-based post-operative pain regimen; with the majority of practitioners opting for a~     combination of acetaminophen and narcotics for pain control. Most rhinologists avoid NSAIDs~     due to decreased platelet aggregation and the theoretical risk of increased post-operative~     bleeding. No studies to date have evaluated the use of ibuprofen in CRS patients following~     ESS. Additionally, there is a lack of information regarding the average narcotic requirement~     following ESS.~      The purpose of this pilot prospective cohort study is to evaluate the use of narcotics in~     sinus surgery and the effect of ibuprofen in the non-packed nose following ESS. This~     investigation will help to gain understanding of current opioid use in post-op sinus patients~     and assess the safety and effectiveness of post-operative ibuprofen administration on pain.~     The investigators aim to quantify the average narcotic use following ESS, as well as evaluate~     the effect of the addition of ibuprofen to the standard analgesic regimen on pain scores and~     post-operative epistaxis. The investigators hypothesize that the use of ibuprofen will~     decrease pain scores on a 10-cm visual analogue scale when compared with individuals who do~     not use ibuprofen post-operatively, this will lead to decreased opioid use in the~     post-operative period. Additionally, the investigators hypothesize no increase in~     post-operative bleeding rates, again based on a 10-cm visual analogue scale and bleeding~     events.~      In summary, this will be the first study to the investigators knowledge to examine the effect~     of post-operative ibuprofen use and its effects on opioid use, as well as pain and epistaxis~     outcomes, in ESS. By performing this pilot prospective cohort study, the investigators will~     be equipped to design and perform the optimal prospective, randomized study evaluating the~     effect of NSAID in ESS during the post-operative period. The overarching goal of this~     investigation is to decrease opioid use in post-operative pain control following ESS.~   "
39053|NCT03055494|"~     This study will provide a comparison of secukinumab to placebo with respect to skin~     inflammation as measured by skin exams in comparison to skin biopsies, adipose tissue and~     blood sample analyses.~   "
39054|NCT03055481|"~     The aim of this trial is to show that the low irradiance level is not worse than the high~     irradiance level in the phototherapy for neonatal jaundice.~   "
39055|NCT03055468|"~     Introduction: The prevalence of Diabetes Mellitus (DM) is on the rise the world over. About~     30% of DM patients suffer from Depression. Depression in DM patients is associated with~     adverse outcomes including poor medication adherence, poor glycaemic control, and early~     death. In resource constrained sub-Saharan Africa (SSA) clinics where patient volumes are~     high and staff shortages rife, peer support has been suggested as a means of delivering~     psychosocial care for persons with chronic illnesses in order to improve patient's outcomes.~     However, little has been done to examine the efficacy of peer support on clinical outcomes.~      Project aims: The main study objective will be developing a peer support model of depression~     care for patients with DM and testing its efficacy on clinical outcomes.~      Methods: This study will employ both qualitative and quantitative measures. First, the~     investigators will present the peer support model to health workers within the DM clinic, and~     ask them about the feasibility of using such a model for DM patients with depression. The~     investigators will then identify 10 DM patients with major depression and initiate them on~     antidepressants. Once the patients are in clinical remission, the investigators will~     interview them to assess their perceptions about the feasibility of using peer support for DM~     patients newly diagnosed with depression. The investigators will also interview health care~     workers and hospital administrators to assess their perception about using peer support~     within the clinics, and potential barriers that need to be addressed before implementation of~     the model.~      Based on the data from the qualitative interviews, the investigators will refine and adapt~     the peer support model, and then train 10 DM patients who have received antidepressants and~     are in clinical remission to deliver peer support to newly diagnosed patients with~     depression. Newly diagnosed depressed patients will be randomly assigned to receive either~     antidepressants plus peer support (n=65) or antidepressants alone (n=65). Study participants~     will be followed for 48 weeks and assessed for, glycaemic control, depression severity,~     mental illness stigma, depression treatment uptake and adherence.~      Result: the investigators anticipate that the findings about the efficacy of peer support on~     DM and depression outcomes will be useful in generating data about effect sizes necessary for~     calculating a sample size for a cluster randomized trial (CRT).~   "
39056|NCT03055455|"~     In critically ill children with severe sepsis, neurophysiologic derangements often proceed~     undetected and can lead to irreversible brain injury causing neurocognitive and behavioral~     deficits. The etiology of these impairments is unclear, however, it is likely that some of~     this neural injury is preventable. The overarching goal for this study is to show that acute~     acquired structural and microstructural brain injury occurs in critically ill children with~     severe sepsis, and that this injury is related to neuropsychological deficits and impaired~     cerebral autoregulation (CAR). Subjects will complete Magnetic resonance (MR) imaging within~     2-10 days of recognition of their severe sepsis. Subjects will undergo serial interrogation~     of CAR for up to 10 days. CAR will be determined by the correlation of arterial blood~     pressure with middle cerebral artery flow velocity measured by transcranial doppler~     ultrasonography and cerebral oximetry derived from near-infrared spectroscopy. Subjects will~     also participate in a neuropsychological evaluation 6 months after enrollment to evaluate~     multiple domains of behavior and cognition.~   "
39058|NCT03055429|"~     The mission of corrections is to provide custody, control and care for incarcerated~     individuals. United States prisons are required by constitutional law to provide adequate~     care for growing numbers of older inmates who will likely spend their final days in prison.~     This Phase II project focuses on the correct users accessing correct learning strategies in~     the correct setting (i.e., interdisciplinary prison staff accessing high quality products~     designed to educate and lead practice change initiatives within the walls of prisons), by~     continuing research and development of a learning system that promotes an integrated systems~     approach to enhancing the care of the aged and dying in prisons.~   "
39059|NCT03055416|"~     African American men are at risk of developing chronic disease partly due to low levels of~     regular physical activity. Studies have been effective in increasing physical activity levels~     in African American men; however for the health benefits of exercise to be maintained~     continued physical activity is necessary. The purpose of the current study is to develop a~     mobile phone application for African American men that will help them maintain their physical~     activity levels.~   "
39060|NCT03055403|"~     This Phase I first-in-human is designed to evaluate the safety, tolerability and~     pharmacokinetics of single ascending doses of M201-A administered by single continuous~     intravenous injection in Healthy Japanese subjects.~   "
39061|NCT03055390|"~     A case control trial Patients who meet the inclusion criteria were asked to participate in~     the study and a written consent was obtained from each patient after explaining thoroughly~     the nature and the scope of the study.~      Patients were divided into three equal groups:~      Group A: included 40 pregnant patients. They received two ml of normal saline intravenously~     as a placebo.~      Group B: included 40 pregnant patients. They received (20mg) hyoscine butylbromide (one ml~     HBB+ one ml saline) intravenously.~      Group C: included 40 pregnant patients .They received two ml (40 mg) hyoscine butylbromide~     intravenously (HBB).~   "
39062|NCT03055377|"~     This is a 12-week randomized, placebo-controlled trial of N-acetylcysteine for cannabis use~     disorder (CUD) in youth (N=192). Participants will be randomized to double-blind NAC or PBO,~     yielding two equally-allocated treatment groups. All participants will receive brief weekly~     cannabis cessation counseling and medication management. The primary efficacy outcome will be~     the proportion of negative urine cannabinoid tests during the 12-week active treatment,~     compared between groups.~   "
39063|NCT03055364|"~     In this study, the investigators propose to evaluate cognitive function and determine the~     feasibility of neurocognitive assessment using a select CogState test battery in patients~     with primary intracranial malignancies receiving photon- or proton-based cranial irradiation~     with curative intent. The investigators will use the CogState software to quantify changes in~     verbal learning, memory, and executive function over the initial months and years following~     radiation treatment. Cognitive changes and temporal patterns of function will be compared to~     baseline performance for each patient. Data regarding cognitive function, fatigue, quality of~     life, and standard patient reported outcomes will be collected to characterize the daily~     impact of treatment. In addition, observed outcomes will be correlated with dosimetry values,~     radiation dose volumes, and anatomic dose distribution.~   "
39064|NCT03055351|"~     Stop&Go is an intervention program aimed at promoting a healthy and physically active~     lifestyle for patients requiring inpatient detoxification treatment. The program includes two~     different phases. Phase I is aimed at understanding the variables related with adherence to~     healthy lifestyle interventions. Phase II will use the knowledge obtained in Phase I to~     develop and evaluate an intervention based on Self-determination theory to promote healthy~     and physically active lifestyles for patients admitted to an inpatient detoxification centre.~     The Stop&Go intervention is hypothesized to help patients move towards a healthy lifestyle~     and thus, may bring about changes in patients' (1) knowledge acquired, (2) indicators of~     healthy habits (e.g., exercise motivation) and (3) psychological well-being and ill-being.~   "
39065|NCT03055338|"~     This will be a randomized, placebo-controlled, parallel-group, multi-site, double-blind trial~     of MK-8189 compared with placebo, using Risperidone as an active control. The participants~     will be adult subjects experiencing an acute episode of schizophrenia, according to the~     criteria specified in the Diagnostic and Statistical Manual of Mental Disorders, 5th ed.~     (DSM-5). This study will be up to 7 weeks in duration, with up to 7 site visits for each~     participant. The study will consist of a Screening/tapering period (up to one week long), a~     4-week treatment period, and a 14-day follow-up period. The primary objective will be to~     assess symptoms of schizophrenia at 4 weeks, and to assess safety and tolerability during~     treatment and post-treatment follow-up. The secondary objective will be to assess the~     severity of schizophrenia at 4 weeks. The primary hypothesis is that MK-8189 is superior to~     placebo in reducing the overall symptoms of schizophrenia as assessed by the mean change from~     baseline in the Positive and Negative Syndrome Scale (PANSS) total score after 4 weeks of~     treatment.~   "
39066|NCT03055325|"~     The aim is to map the inflammatory response after surgery and further investigate the~     mechanisms by which inflammation is regulated. The inflammatory cascade is pivotal in~     protecting organisms against invading pathogens and in enabling healing of damaged tissues,~     yet the cascade itself may be harmful to the organism when excessive (e g septic chock).~      The increased immune-reactivity after trauma, such as surgery, is furthermore associated with~     post-operative declines in memory and learning capacity, a condition likely related to the~     notion of sickness behavior. The effects on the brain after surgery and the associated~     neuro-immune crosstalk will now be investigated with focus on changes in immune reactivity in~     peripheral blood after surgery.~   "
39067|NCT03055312|"~     Compare the efficacy of bicalutamide with conventional chemotherapy (Treatment of Physician's~     Choice,TPC) in first-line treatment of AR positive metastatic triple negative breast~   "
39068|NCT03055299|"~     The goal of the COMprehensive EXercise (COMEX) pilot study is to test feasibility,~     tolerability and adherence of this novel video-based intra-dialytic chair exercise program~     for hemodialysis patients over 3 months.~   "
39069|NCT03055286|"~     This is a multicenter (S. Korea/US), Phase Ib, open-label, dose-finding study to assess~     safety, PK, PD, and preliminary efficacy of CWP232291 administered in combination with ara-C~     in subjects with relapsed or refractory AML.~      The primary objectives in phase 2a is to assess the efficacy of CWP232291 administered in~     combination with cytarabine (response rate complete remission [RR-CR]/complete remission with~     incomplete blood count recovery [CRi]/partial remission [PR]).~   "
39070|NCT03055273|"~     This research is being done to find out the best ways to help people with end stage kidney~     disease take care of their daily lives and improve their social functioning.~      Investigators want to learn whether services in the Community Aging in Place, Advancing~     Better Living for Elders (CAPABLE) study such as help with medications, muscle strengthening,~     balance training, pain management, changes to houses and improved social support can be~     tailored to fit the needs of older adults with kidney disease to help improve their ability~     to balance, walk, and take care of themselves.~      People aged 60 years and older who have end stage kidney disease and have been receiving~     dialyses for at least 6 months, may join.~   "
39071|NCT03055260|"~     The particpant will complete baseline testing by measuring subjects' quadriceps muscle~     thickness (cm) via ultrasound technology, as well as have them complete a one repetition~     maximum (1RM) test on the leg press machine and an isometric knee extension using a~     dynamometer - strength measures will be calculated for both right and left legs. After~     baseline testing, subjects will complete 6 weeks of the testing protocol that will consist of~     leg press exercises at 30% of their 1RM. Subjects will be randomized to either wear a cuff~     that partially restricts blood flow to the limb (Study Group), or to wear a cuff that does~     not restrict blood flow (Control Group). Exercises will be completed 2x/week and will take~     approximately 10 total minutes (5 for warm up, 5 for testing protocol) per session. After 6~     weeks, muscle thickness, leg press 1RM, and quadriceps extension strength will be re-tested~     and compared to the initial measurements.~   "
39072|NCT03055247|"~     This is a phase II exploratory study conducted to evaluate the safety and efficacy of the~     combination of Ibuprofen, G-CSF and Plerixafor as stem cell mobilization regimen in patients~     affected by X-CGD.~   "
39073|NCT03055234|"~     This is a multicenter, randomized (2:1; oral treprostinil:placebo), double-blind,~     placebo-controlled event-driven (time to pulmonary hypertension [PH] clinical worsening)~     study in subjects with PH associated with sickle cell disease (SCD). Once enrolled, subjects~     will be evaluated at Weeks 6, 12, 24, and then every 12 weeks for the duration of the study.~     Subjects will be permitted to enter a 48-week open-label extension period if they experience~     a PH clinical worsening event.~   "
39074|NCT03055221|"~     This was an open-label extension of Study RIV-PH-402, TRUST-1: Treprostinil for Untreated~     Symptomatic Pulmonary Arterial Hypertension (PAH) Trial. Subjects who completed Study~     RIV-PH-402 were eligible to enroll.~   "
39075|NCT03055208|"~     Gamma GBM is a single-arm phase II trial that prospectively measures the progression-free~     survival time after addition of an early gamma knife boost to areas of residual tumor to~     standard-of-care (surgery, chemo-radiotherapy, chemotherapy).~   "
39076|NCT03055195|"~     Mepolizumab is a humanized Immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that acts on~     Interleukin-5 (IL-5), which is responsible for the growth and differentiation, recruitment,~     activation, and survival of eosinophils; thereby reducing the production and survival of~     eosinophils which may be therapeutic in subjects with atopic dermatitis (AD). This study will~     investigate the efficacy and safety of mepolizumab (100 milligram [mg] subcutaneous [SC]~     administered every 4 weeks) compared with placebo in adult subjects with moderate to severe~     atopic dermatitis (AD). Subjects will be randomized 1:1 to either placebo SC or mepolizumab~     SC. The study will comprise of a pre-screening period of up to approximately 4 weeks, a~     screening period of up to 2 weeks, followed by a 16-Week study treatment period (16 weeks~     with the last dose of study treatment at Week 12) and follow-up period of up to 4-week. The~     total duration of subject participation will be approximately 26 weeks. (Note: For subjects,~     who may need to stop treatment with a biologic, the total Pre-Screening and Screening period~     may last up to 20 weeks and total duration of participation in the study may be up to 40~     weeks).~   "
39077|NCT03055182|"~     The study evaluate paraspinal aerobic metabolism of chronic low back pain patients and~     healthy people during an original and standardized isokinetic protocol.~      The aim of this study is to determine a potential alteration of muscular aerobic metabolism~     in low back pain patients, in order to establish the underlying cause of pain and muscular~     fatigability characterizing low back pain patients. Then, the aim is to determine if~     functional rehabilitation program can improve it.~      the unit of care have access to metabolic adaptations in measuring the muscular oxygenation~     and the pulmonary oxygen consumption, using near infrared spectroscopy and gas analyser.~   "
39078|NCT03055169|"~     This study evaluates the link between genetic polymorphisms as r7903146, rs12255372 of TCF7L2~     gene and the risk of developing hyperglycemia during Intensive care unit stay~   "
39079|NCT03055156|"~     The purpose of the study is to evaluate effects of high rebound mattress toppers (i.e.,~     airweave®) on sleep and sleep-related symptoms.~      The study will compare effects of use of high rebound mattress toppers versus use of low~     rebound mattress toppers on sleep and sleep related symptoms and core body temperature during~     diagnostic sleep studies.~   "
39080|NCT03055143|"~     This was a randomized, multi centre, open label, two treatment, two period, two sequence,~     single dose, crossover study, with at least 28 days washout between doses, conducted under~     fed (normal breakfast) conditions.~   "
39081|NCT03055130|"~     The associations between female inflammatory bowel disease (IBD) patients and human papilloma~     virus (HPV) infection and cervical neoplasia (dysplasia or cancer) were unclear. Especially~     there was no data for Chinese IBD population. So we investigated the incidence and risk~     factors of HPV infection and cervical neoplasia (dysplasia or cancer) in female IBD patient.~   "
39082|NCT03055117|"~     Degenerative shoulder disorders are frequent in the Danish population and often cause~     disability and sick leave. After hospital discharge patients are often referred to~     physiotherapy rehabilitation as part of the treatment, and it is often assumed that~     one-on-one sessions will yield better results than group-based sessions, because individual~     needs can be better meet and targeted~      The project aims to evaluate the effect and cost-effectiveness of group- based exercise~     rehabilitation as compared to individual exercise rehabilitation in patients with~     degenerative shoulder disorders.~   "
39119|NCT03054623|"~     Our study seeks to define the effect of each component of the distal revascularization~     interval ligation (DRIL) procedure on the in vivo distal blood pressure of patients with~     ischemic steal, and to determine whether the interval ligation component of the DRIL~     procedure is necessary or not.~   "
39083|NCT03055104|"~     Severe malnutrition can be seen as a low BMI, great weight loss, and even low levels of~     micronutrients. Current studies on severe malnutrition are mainly in patient with anorexia~     nervosa. The refeeding phase of these high-risk patients bears a further threat to health and~     potentially fatal complications (such as refeeding syndrome, infection and severe~     arrhythmia). The objective of this study is to investigate complications due to refeeding of~     patients with severe malnutrition, as well as their mortality rate, establish and modify the~     guideline for management of severe malnutrition in Peking University Third Hospital.~   "
39084|NCT03055091|"~     This is a randomized controlled trial of regular daily use of xylitol (or birch sugar), a~     natural sweetener that has antimicrobial properties, for the prevention of acute otitis media~     (AOM, primary outcome) as well as upper respiratory tract infections and dental caries (the~     two secondary outcomes) in preschool aged children. This trial will be conducted through the~     TARGet Kids! research network.~   "
39085|NCT03055078|"~     This study is to evaluate the safety and efficacy of Umbilical Cord Derived Mesenchymal Stem~     Cells transplantation in aplastic anemia.~   "
39086|NCT03055065|"~     The objectives of this study is to assess the characteristics and frequency of adenovirus~     conjunctivitis in a population of male and female patients from one year of age who present~     signs and symptoms of acute conjunctivitis.~   "
39087|NCT03055052|"~     This study evaluates the effects of infant formula with higher protein level and improved fat~     blend on growth and feeding tolerance in preterm infants. Half of the subjects will receive a~     standard infant formula, while the other half will receive a infant formula with a higher~     protein level and improved fat blend.~   "
39088|NCT03055039|"~     The nociceptif system of the newborn child is functional from 22 to 23 weeks of pregnancy.~     During the delivery the baby is exposed to multiple exterior factors and he is capable to~     memorize the pain .Recent epidemiologic studies showed that the coverage of pain was~     insuffcient and also an increase of analgesic means. Normally the pain coverage have to be~     managed and group every painful gesture. In fact all these recommandations are not followed~     by medical team.~      The aim of the study is to evaluate the prevalence of this type of pain as to set up an~     adequate coverage.~   "
39089|NCT03055026|"~     Rivaroxaban or placebo for extended antithrombotic prophylaxis after laparoscopic surgery for~     colorectal cancer: a randomized, double blind, placebo-controlled study.~   "
39090|NCT03055013|"~     This randomized phase III trial compares nephrectomy (surgery to remove a kidney or part of a~     kidney) with or without nivolumab in treating patients with kidney cancer that is limited to~     a certain part of the body (localized). Monoclonal antibodies, such as nivolumab, may~     interfere with the ability of tumor cells to grow and spread. Giving nivolumab before~     nephrectomy may make the tumor smaller and reduce the amount of normal tissue that needs to~     be removed, and after nephrectomy to increase survival. It is not yet known whether nivolumab~     and nephrectomy is more effective than nephrectomy alone in treating patients with kidney~     cancer.~   "
39091|NCT03055000|"~     Background:~      Mosquitos carry diseases that cause major health problems and death worldwide. The AGS-v~     vaccine targets proteins in mosquito saliva. This may help prevent many mosquito-borne~     diseases. It might also reduce the lifespan of the mosquito that bites the vaccinated person.~      Objective:~      To see if the AGS-v vaccine is safe in humans and how it affects the immune system.~      Eligibility:~      Healthy adults ages 18-50~      Design:~      Participants will be screened another study.~      Participants will be randomly assigned to get either the vaccine with a booster vaccine, the~     vaccine without the booster, or a placebo. These are given through a needle in the upper arm.~      Participants will have visits that include medical history, physical exam, and blood and~     urine tests:~      Baseline: They will get the vaccine and be monitored for 2 hours.~      Follow-up visits 1 and 2 weeks after baseline.~      Visit 3 weeks after baseline: They will get the booster and be monitored for 2 hours.~      Follow-up visits 1 and 2 weeks after booster visit.~      Visit 3-5 weeks after booster visit: This includes mosquito feeding. Mosquitos grown in the~     lab will be allowed to bite the arm. Blood will be drawn 4 times in the 3 hours after the~     feeding.~      Phone follow-up a few days after the mosquito feeding.~      After the feeding visit, 5 follow-up visits about every 2 months~      Participants will keep a symptom diary for 7 days after each vaccine. They will record their~     temperature. They will measure any redness around the injection site. They will document and~     if possible photograph any mosquito bites they get.~   "
39092|NCT03054987|"~     The purpose of this study is to compare the rates of adverse events between patients~     undergoing Endoscopic Ultrasound- guided biliary drainage and Endoscopic Retrograde~     Cholangiopancreatography for distal malignant biliary obstruction.~   "
39093|NCT03054974|"~     The purpose of this study is to determine the effectiveness,safety and Input-output ratio of~     chinese traditional treatment in spasm after stroke,both in massage and herbal medicine~     bathing.~   "
39094|NCT03054961|"~     The purpose of this pilot study is to describe the relationship of regional cerebral oximetry~     and cytoximetry, measured using near-infrared spectroscopy, with seizure activity in the~     periictal period in children with epilepsy.~   "
39095|NCT03054948|"~     Soybean oil based IV fat emulsion (IVFE) has been one of the sole sources of IVFE in the US.~     Soybean oil based IVFE has higher ratio of omega-6 to omega-3 fatty acids and can be~     associated with a number of complications including inflammation, abnormal liver function~     tests (reflecting steatosis, cholestasis, etc.), and metabolic abnormalities. Recently the~     FDA has approved SMOFlipid which contains a mixture of soybean oil, medium chain~     triglycerides, olive oil, and fish oil. It provides a more positive ratio of omega-3 to~     omega-6 fatty acids and has been shown in short term trials to be beneficial in cases of~     intolerance to soybean oil IVFE. This study is designed to investigate the impact of~     SMOFlipid in prolonged use.~   "
39096|NCT03054935|"~     The aim of this study is to investigate the effect disease activity on resting energy~     expenditure (REE), body composition, inflammatory markers, food intake and quality of life in~     subjects affected by Crohn's Disease (CD)~   "
39165|NCT03054025|"~     This pilot clinical trial studies how well a smart phone application works in increasing~     physical activity in breast cancer survivors. A smart phone application that increases~     physical activity may help reduce the likelihood of cancer coming back in breast cancer~     survivors.~   "
39097|NCT03054922|"~     During major surgical procedures, intravascular volume is maintained with the administration~     of isotonic fluids such as Lactated Ringers (LR), Normal Saline (NS) or Normosol-R. All three~     of these fluids are in common clinical use for this purpose. As large volumes of NS may~     result in a dilutional acidosis and an increasing base deficit, it may cloud clinical~     decision making when resuscitative efforts are guided by acid-base status on routine arterial~     blood gas analysis. This is a prospective, randomized study to evaluate changes in acid-base~     and electrolyte (sodium, potassium, calcium) status with the use of various isotonic fluids~     for intraoperative resuscitation.~   "
39098|NCT03054909|"~     This is a single center, randomized phase II study of an IL-15Rα-Fc super-agonist complex~     (ALT-803) given as maintenance therapy after the completion of 1st line IV/IP chemotherapy~     for the treatment of advanced ovarian, fallopian tube, and primary peritoneal cancer.~   "
39099|NCT03054896|"~     This research study is evaluating the combination of a study drug, venetoclax, and a standard~     chemotherapy regimen, EPOCH-R, as a possible treatment for Richter's Syndrome.~      The drugs involved in this study are:~        -  Venetoclax~        -  EPOCH-R:~        -  Etoposide~        -  Prednisone~        -  Vincristine Sulfate (Oncovin)~        -  Cyclophosphamide~        -  Doxorubicin Hydrochloride (Hydroxydaunomycin)~        -  Rituximab~   "
39100|NCT03054883|"~     This is an observational study aimed to analyze the effectiveness of treatment of patients~     with newly dg. mantle cell lymphoma not eligible for high-dose therapy and autologous stem~     cell transplantation. Scheme of treatment: alternating cycles of R-CHOP (rituximab,~     cyclophosphamide, hydroxydaunomycin, oncovin, prednison) and R-AraC (rituximab, cytarabin):~     R-CHOP / R-AraC / R-CHOP / R-AraC / R-CHOP / R-AraC. The study was proposed based on the~     previously published data in the younger patients, which demonstrated improved outcome after~     implementation of Ara-C into induction.~   "
39101|NCT03054870|"~     Phase 3 within-subject non-inferiority trial of Technegas ventilation imaging compared to~     Xenon-133 (Xe-133) ventilation imaging to demonstrate the non-inferiority of Technegas~     compared to Xe-133 ventilation studies with respect to subject pulmonary ventilatory~     distribution. Subjects will undergo site-specific standard of care (SOC) Xe-133 imaging per~     medical needs followed by Technegas ventilation imaging per study protocol.~   "
39102|NCT03054857|"~     Objective: The aim of this study was to determine the effect of dexmedetomidine in reducing~     postoperative cognitive dysfunction (POCD) in cardiac surgical patients which use~     cardiopulmonary bypass machine (CPB).~      Materials and Methods: This study was double-blinded, randomized controlled trial. Patients~     scheduled for elective CPB facilitated cardiac surgery were randomly assigned in two groups,~     dexmedetomidine group (DEX) or control group. The cognitive tests (MoCA test and Short bless~     test) were done before the operation, 48 hours, and 7 days postoperatively. POCD was defined~     as a decline of 1SD of baseline score in any test. Arterial blood sample were analyzed for~     IL-6, IL-10, TNF-alpha and hs-CRP before induction (T0), after separation from CPB (T1),~     arrival at ICU (T2) and 24-hour after surgery (T3). Primary outcome was the incidence of POCD~     and the secondary outcomes were inflammatory response, other postoperative complications, ICU~     and hospital stay.~   "
39103|NCT03054844|"~     Intranasal (IN) midazolam is an anxiolytic that is commonly used in the pediatric population~     for procedural anxiolysis in the emergency department (ED) setting to facilitate painful and~     distressing procedures, such as laceration repairs. Intranasal midazolam is both effective~     and safe in children. However, due to the acidic nature of midazolam, there is a burning~     sensation that is associated with the intranasal administration of midazolam. The use of IN~     lidocaine has been shown to decrease the pain associated with the administration of IN~     midazolam and other acidic solutions. The IN lidocaine can be given as a premedication~     (PREMED), where it is sprayed in the nares first to provide topical anesthesia, and then~     followed by the administration of the IN midazolam. Lidocaine can also be given concurrently~     with the IN midazolam (PREMIX), where it is mixed with the midazolam and then the combined~     mixture administered. Both methods have been shown to be effective in decreasing the pain~     associated with the intranasal administration of acidic solutions, such as midazolam,~     although the PREMIX method could have the advantage of requiring less number of sprays, and~     be tolerated better by children. Although both methods have been shown to work, it is not~     known if the PREMIX method is non-inferior to the PREMED method for decreasing pain and~     distress associated with administering IN midazolam. Therefore, the investigators aim to~     determine if the PREMIX method is non-inferior to the PREMED method of using lidocaine to~     decrease the pain and distress associated with the administration of IN midazolam in~     children.~   "
39104|NCT03054831|"~     Oxycodone is an oral opioid analgesic that is most commonly prescribed for the management of~     pain in post-operative patients at Boston Children's Hospital. Oxycodone has been widely used~     in adults and children to relieve post-operative pain. However, its pharmacokinetics (what it~     does in the body) and pharmacodynamics (how it works) have not been well established in~     children. Some children, because of their specific genetic make-up, may metabolize the drug~     more quickly and therefore may be at risk for more side effects in the commonly prescribed~     dose. The investigators would like to find out more about how general anesthesia (GA) effects~     how this drug is absorbed, metabolized and excreted in children. In order to study these~     aspects, the investigators would like to give oxycodone to surgical patients (group one will~     receive oxycodone at the beginning of GA and group two will receive oxycodone at the end of~     GA) at Boston Children's Hospital then measure its metabolic activity and also perform a~     specific genetic analysis.~   "
39105|NCT03054818|"~     This is a post-marketing drug safety monitoring study in a prospective manner, and data~     collection will be performed in a registration-follow-up manner. Safety information about~     patients who have received intravitreal injection of Conbercept Ophthalmic Injection in~     medical institutions involved in the study during research will be actively monitored without~     intervening in diagnosis and treatment. All patients enrolled will be followed up for one~     year.~   "
39106|NCT03054805|"~     To compare the differences of fecal microflora between constipated and non-constipated~     healthy children, and evaluate the efficacy of probiotics in reducing symptoms of~     constipation and the influence of intestinal microflora in children with functional~     constipation.~   "
44624|NCT02982720|"~     This is an open-label, single-arm, multicenter Phase II safety and efficacy study of~     combination therapy with pembrolizumab and Sylatron (Peginterferon alpha-2b) in patients with~     advanced cholangiocarcinoma who have progressed on or cannot tolerate frontline chemotherapy.~   "
39107|NCT03054792|"~     This study will test the feasibility of using novel/existing imaging technologies focused on~     hypoxia measurements to determine response to therapy in pediatric soft tissue sarcomas as~     a pilot study. Specifically, the investigators will compare the sensitivity of Blood Oxygen~     Level Dependent [BOLD], Diffusion-Weighted [DW] MRI, Magnetic Resonance Spectroscopy (MRS)~     and 18F-FAZA PET-MRI with that of conventional MRI to detect measurement changes between the~     start and completion of neoadjuvant therapy (response to therapy) in children and~     adolescents (7-18 years) with suspicion of sarcoma tumors. Clinicians and scientists may use~     results of the proposed hypoxia-imaging surrogate markers to adjust/modify therapeutic~     schemes to patients on a personalized basis.~   "
39108|NCT03054779|"~     Building on the findings from the investigators previous study, COMIT I, the purpose of the~     COMIT II study is to supplement the DEXA measurement of body composition with a supplementary~     DEXA measurement of visceral adipose tissue and to specifically target the impact of oleic~     acid consumption on body composition as the primary objective. COMIT II also will include~     analysis of fatty acid ethanolamines (FAEs) and their precursors to elucidate the mechanisms~     by which canola oil may be modifying body composition, measurement of endothelial function,~     inflammatory, adiposity and insulin sensitivity biomarkers, and genetic analyses.~   "
39109|NCT03054766|"~     To investigate the efficacy of laser photocoagulation combined with ranibizumab intravitreal~     injection in macular edema (ME) secondary to branch retinal vein occlusion (BRVO) in long~     term.~   "
39110|NCT03054753|"~     The postoperative shoulder rehabilitation in an abduction brace after rotator cuff~     reconstruction of the shoulder is crucial for a successful healing of the reconstruction.~      In this study the investigators want to analyse the abduction brace-wearing time using a~     electronic sensor, which is implanted in the abduction brace. The participants will be~     informed about the sensor after completion of the abduction brace rehabilitation 6 weeks~     postoperatively.~   "
39111|NCT03054740|"~     The primary purpose of this study is to determine if by offering a vapocoolant (cold spray)~     to hospital outpatients prior to an intravenous catheter (IV) insertion will increase patient~     satisfaction of IV insertion as well as determine if pain of insertion is decreased.~   "
39112|NCT03054727|"~     Post-thrombotic syndrome (PTS) is a frequent and burdensome complication of deep-vein~     thrombosis (DVT). In the absence of curative treatment of established PTS, its management is~     based on the prevention of its occurrence thanks to anticoagulants and compression stockings.~      So far, predictors of disabling PTS are unknown precluding from optimally selecting patients~     for invasive (early thrombus removal) or innovative/expensive treatments. In addition, little~     is known on the incidence of PTS in the very long-term.~      Objectives: To assess, 12 years after a symptomatic venous thromboembolic (VTE) event,~     Primary objective: incidence and severity of PTS after a lower limb DVT.~      Main Secondary objectives:~        1. Incidence and severity of PTS according to VTE initial presentation (isolated distal~          DVT, isolated proximal DVT, PE + DVT).~        2. Incidence and risk factors of disabling PTS Methods: Very long-term follow-up (12 years)~          of patients recruited in the large, multicentre, prospective, observational OPTIMEV~          study for a suspicion of VTE confirmed or ruled out with objective tests (Clinical~          Trials NCT00670540).~      All patients with a DVT, an isolated PE and a random selection of controls (VTE - patients~     without any history of VTE after the 3 years of follow-up) will first benefit from a~     phone-PTS assessment. Those patients presenting at least a mild venous insufficiency and a~     selection of controls will undergo a clinical follow-up visit with clinical and Compleat~     Ultra Sound (CUS) assessment of PTS/venous insufficiency and an assessment of quality of~     life.~      Perspectives: Improving our knowledge of PTS' incidence and predictors and of the impact of~     usual treatment. Better selecting patients eligible for invasive/innovative/expensive~     preventative procedures.~   "
39113|NCT03054714|"~     Prospective, randomized Study of tunneled cuffed hemodialysis catheter removal and delayed~     replacement, versus exchange over a guidewire to treat catheter related blood stream~     infection~   "
39114|NCT03054701|"~     Patellofemoral pain (PFP) is highly prevalent in both adolescent and adult populations and as~     much as 91% of those affected experience ongoing knee pain for up to 20 years after the~     initial diagnosis.~      Exercise-based treatment focusing on strengthening the muscles around the hip and knee is~     usually effective when treating patient with PFP. However, this approach has proven~     ineffective in a subgroup of females who have suffered from PFP for multiple years.~      This group was found to have a significantly lower tolerance for pressure stimuli compared to~     healthy controls. This indicating that central mechanisms within the nervous system rather~     than the problem being the knee itself.~      Exercising a non-painful muscle distant to a painful part of the body has previously been~     effective in deceasing pain in affected area. This mechanism has been investigated in~     patients with long-standing musculoskeletal pain as well as healthy populations.~      Related research has suggested that a possible link between patients perception of painful~     stimuli an the pain-reducing effect of exercise exists. As such, patients witch experienced a~     pain reducing effect of exercise was found to be able to tolerate more pain than before the~     intervention.~      The aim of this study is to assess if exercising a distant non-painful muscle around the hip~     has a larger acute pain-reducing effect on knee pain compared to knee specific exercises in~     female patients with long-standing PFP.~   "
39115|NCT03054688|"~     Comparison of 24 hours blood pressure measurement with puls-transit time versus cuffs.~   "
39116|NCT03054675|"~     Aim of this study was to prospectively investigate the correlation between postoperative~     spirometry values and pulmonary complications after anatomic lung resections. In addition,~     the investigators compared postoperative pulmonary function changes between open and~     minimally invasive approaches.~   "
39117|NCT03054662|"~     This study aims to make an inventory of the condition and care of patients with haemophilia~     and carriers for haemophilia in Ivory Coast and to promote the use non substitutive~     strategies that are not costly and available in Ivory Coast, to improve the management of~     haemophilia in this country. The purpose of this project is to evaluate the extent to which~     the active promotion of these various measures will improve the care of patients with~     haemophilia and carriers in Ivory Coast.~   "
39118|NCT03054636|"~     The Short term Perfusion Angiography (SPA) study is designed to collect 2D Perfusion data~     from Critical Limb Ischemia (CLI) endovascular (interventional) procedures for information on~     device performance in a real-world setting.~   "
39120|NCT03054610|"~     Plantar fasciitis is the most common cause of plantar heel pain and is commonly present in~     people 40 years of age or older, overweight, sedentary or with intense physical activity. It~     is caused by the over-stretching of the plantar fascia, which is a band of connective tissue~     that extends to the base of the phalanges. This produces micro-tears more commonly in its~     origin in the medial tuberosity of the calcaneus which causes an inflammatory process and~     pain. This pain usually occurs when the person gets up in the morning after sleeping or after~     sitting for a long time. That is when the fascia is stretched after being in a contraction~     position.~      There are a great variety of treatments for this pathology, of these, one of the most common~     is the use of intralesional steroids, which a weighing that reduces symptomatology in many~     cases also has undesirable effects such as subcutaneous fat atrophy, rupture of the plantar~     fascia, peripheral nerve injury, muscle damage and stress fractures. Other treatments are~     extracorporeal shock waves, application of platelet-rich plasma and application of botulinum~     toxin A intralesional. All of them are accompanied by insoles, night splints and stretching~     exercises of the Achilles tendon and the plantar fascia.~      Recent studies have shown that the application of botulinum toxin A intralesional in patients~     with plantar fasciitis helps to improve the symptomatology to decrease pain in both intensity~     and presentation time. Decreased inflammation of the plantar fascia has also been~     demonstrated. This is the sale of the usual form of action of the botulinum toxin, which is~     applied regularly in the muscles to block the release of acetylcholine in the neuromuscular~     plaque and obtain its relaxation and not directly in the pain points. We believe that the~     botulinum toxin can be applied intralesional currently, since there is information that the~     toxin has analgesic and anti-inflammatory effect and not just muscle relaxation.~      The aim of our work demonstrate that the use of botulinum toxin A and intralesional~     stretching exercises is superior to intralesional steroids and stretching trying to establish~     a safer and less painful therapy avoiding complications prior to the application of steroid~     application.~   "
39121|NCT03054597|"~     Children in the United States watch an average of twenty-eight hours of television and play~     around thirteen hours of video games per week. The objective of this experiment was to see if~     a specific eye exercises could strengthen the eye muscles and improve the peripheral vision~     range of children and adults.~   "
39122|NCT03054584|"~     The objective of this protocol is to further elucidate the genetic mutations that drive~     melanocytic nevi (benign melanocytic neoplasms, moles). This will be performed by whole~     genome, whole exome, or targeted sequencing of de-identified specimens.~      Herein, the investigators plan to isolate DNA from de-identified skin biopsy specimens and~     blood samples:~        1. From melanocytic nevi collected by skin biopsy (a shave or punch biopsy). A part of the~          tissue will be submitted for routine diagnostic dermatopathology and investigational~          histomorphologic and immunohistochemical analysis.~        2. From corresponding normal tissue (blood). DNA isolated from blood will be used as a~          normal control when analyzing sequencing data to identify somatic mutations in lesional~          tissue.~   "
39123|NCT03054571|"~     This investigation seeks to build upon existing evidence that a relationship exists between~     body mass and timing and the number of erupted teeth.~   "
39124|NCT03054558|"~     Patients with history of two or more recurrent pregnancy loss (RPL) and no history of living~     babies who had performed all investigations for recurrent miscarriage (RM) including :~     laboratory investigation ,trans vaginal ultrasound (TVS) ,autoimmune work up and hystroscopy~     and all results were free,will be scheduled for three dimensional trans-vaginal ultrasound~     (3D TVS) in the midluteal phase for measuring the impedance of uterine artery blood flow( by~     two dimensional Power Doppler TVS).Also by using 3D power Doppler the sub-endometrial blood~     flow will be assessed. In addition to the thickness of Junctional Zone (JZ) by using coronal~     view of 3 D TVS. To be compared with patients who had at least one full term living baby~     through normal vaginal delivery with no history of early pregnancy loss.~   "
39125|NCT03054545|"~     This study is to evaluate the efficacy and safety of a novel chemical synthetic agent~     iguratimod as treatment of refractory lupus nephritis. All subjects should have at least one~     failed immunosuppressive treatment and suffer active nephritis at the screening stage. The~     study period is 52 week. All the subject will receive therapy of iguratimod combined with~     steroids.~   "
39126|NCT03054532|"~     This is a multi-center, open-label, phase II study of durvalumab in combination with~     lenalidomide for treatment of relapsed/refractory NK/T-cell lymphoma (NKTCL). The study will~     employ a 2-stage Simon Optimal design with 80% power and type 1 error rate (significance~     level) of 5%. Stage 1 will involve 8 patients and will require at least 2 patients to achieve~     the primary end point of overall response in order to proceed onto to stage 2, which will~     have a target enrolment of 14 patients.~   "
39127|NCT03054519|"~     The PERMET trial will determine whether metformin daily for six months improves six-minute~     walk performance in individuals with peripheral artery disease compared to placebo.~   "
39128|NCT03054506|"~     Constipation is a common gastrointestinal motility disorder that is often chronic, negatively~     affects patients' daily lives. Constipation occurs when bowel movements become difficult or~     less frequent.This study is being done to study the effectiveness of the hydrogel capsule,~     CSP01, compared to the active control (carboxymethylcellulose) and placebo (non-medicine~     sugar pill), to relieve constipation among subjects with chronic idiopathic constipation~     (CIC) or with irritable bowel syndrome with constipation (IBS-C).~   "
39129|NCT03054493|"~     1. Prevalence of non-nutritive sucking habits (NNSH) in a group of Egyptian children aged~          3-8 years old in Giza Governorate.~        2. Assessment of factors associated with NNSH.~   "
39130|NCT03054480|"~     Because of the limiting data about an efficacy and safety of fractional radiofrequency for~     the treatment of hyperhidrosis, this study aim to compare clinical efficacy by Hyperhidrosis~     Disease Severity Score (HDSS) between Fractional Microneedle Radiofrequency device and~     intradermal Botulinum toxin type A injection for the treatment of primary axillary~     hyperhidrosis. The secondary objectives to determine the improvement change of iodine starch~     test, total amount of sweat production by trans-epidermal water loss (TEWL), patient's~     satisfaction and their quality of life by Dermatology Life Quality Index and side effect~     between the groups.~   "
39131|NCT03054467|"~     The aim of the present study is to compare the effects of CCB and CCB+ high dose of statin~     therapy on the symptoms, function, and quality of life assessed by validated angina-specific~     questionnaire (Short-form Seattle Angina Questionnaire (SAQ-7)), endothelial function as~     measured by FMD of the brachial artery, endothelial progenitor cells (EPC) and coronary flow~     reserve (CFR) in patients with VSA.~   "
39207|NCT03053479|"~     Pelvic organ prolapse, POP, is a common health problem affecting up to 40% of women. Very~     little is known about the factors associated with surgical failure. Studies have identified a~     variety of risk factors: younger age, high body mass index and advanced preoperative prolapse~     (grade III-IV) have been associated with an increased risk of reoperation in some studies.~     According to some studies patients had poorer anatomical outcome after traditional repairs~     but were able to enjoy the same quality of life as after transvaginal mesh surgery or~     laparoscopic sacrocolpopexy. The purpose of this study is to assess and compare the efficacy~     of these three procedures in a randomized controlled trial.~   "
39132|NCT03054454|"~     Observational studies clearly show that people with diabetes and end-stage kidney failure~     have an increased risk of foot ulceration and leg amputation. However, there is very little~     evidence on addressing this problem.~      Diabetes foot care teams have been shown to reduce hospital admissions, length of stay and~     leg amputation in people with diabetes. Since their introduction at The James Cook University~     Hospital (JCUH) major diabetes-related leg amputation rates have fallen by 86 percent (1995~     to 2010).~      People with diabetes and end-stage kidney failure require haemodialysis (blood cleaning) 3~     times per week for several hours each time. This time commitment makes it difficult to attend~     other clinical appointments. An audit at JCUH shows that this population fails to attend the~     normal diabetes foot services.~      This project aims to reduce the incidence of foot disease in people with diabetes and~     end-stage kidney failure on dialysis. The investigators will set up a podiatry-led~     intervention within the dialysis unit to prevent and promptly treat foot disease in this~     population. This will involve foot risk assessment, risk reduction and treatment during~     dialysis. The intervention will involve diabetes consultants, podiatrists, vascular and~     orthopaedic surgeons . In this way the investigators hope to reduce leg amputation, hospital~     admission, procedures to unblock arteries and death in this high risk group.~      The study will run in the dialysis unit at JCUH. Patients will be divided into two groups:~     those attending for dialysis on a Monday, Wednesday and Friday will form the treatment group~     and those attending on a Tuesday, Thursday and Saturday will continue to be managed as at~     present. The investigators will collect data from patient health care records looking in~     particular at leg amputations, hospital admissions due to foot problems, foot surgery and~     operations to unblock arteries.~   "
39133|NCT03054441|"~     In hemiplegia quantitatively measurement of the asymmetry in the use of upper limbs could~     overcome the limitation of many outcome measures in which scores are dependent on the~     experience and training of the therapist. The main aim of this study was to determine the~     validity of Actigraph GXT3+ to measure asymmetry in the use of the two upper limbs during the~     Assisting Hand Assessment (AHA) in children, adolescents and young with hemiplegia aged 5-19~     years, compared to age-matched typically developing subjects (TD).~   "
39134|NCT03054428|"~     To demonstrate the efficacy of dupilumab as a monotherapy in patients ≥12 years to <18 years~     of age with moderate-to-severe atopic dermatitis (AD)~   "
39135|NCT03054415|"~     This study aims to assess the phenotype of the enteric nervous system (enteric neurons) in~     healthy subjects.~      The enteric nervous system (ENS) is composed by enteric neurons and enteric glial cells.~     There is a cross-talk between ENS and the intestinal epithelial barrier (IEB). ENS and IEB~     together constitute the neuronal-glial-epithelial unit. This unit has a key role in gut~     functions. The characteristics and the phenotype of the ENS also change according to age and~     environmental factors. Similar study is ongoing for patients with Spina Bifida. Anorectal~     data and phenotype of the neuronal-glial-epithelial unit in healthy subjects is required to~     assess abnormality of these items in patients with neurological disease including Spina~     Bifida.~   "
39136|NCT03054402|"~     This study is a first in human study that will investigate the safety, tolerability and~     pharmacokinetics and explore the pharmacodynamics of ascending single doses of BAY1834845~     using a placebo controlled, randomized, single center design.~   "
39137|NCT03054389|"~     The purpose of this study is to seek to understand the patient's perspective around deciding~     to participate in a clinical trial for a Hemophilia therapy~   "
39138|NCT03054376|"~     The study includes healthy young habitually active subjects. All subjects are subjected to~     two weeks of immobilization of one leg followed by four weeks of training of both legs. The~     subjects are randomized to either one-leg training of the non-immobilized leg during the~     two-week immobilization period or to no training of the non-immobilized leg during the~     immobilization period. Measures include skeletal muscle morphology, markers of angiogenesis~     and apoptosis, muscle metabolic markers, vascular function, vascular proteins and~     performance.~   "
39139|NCT03054363|"~     This is a multicenter run-in phase Ib / roll-over phase II study of triple targeted drug~     combination (HER2-targeted small molecule inhibitor tucatinib, CDK4/6 inhibitor palbociclib~     and aromatase inhibitor letrozole) as a first or second line of therapy in patients with~     metastatic hormone receptor positive and HER2-positive breast cancer.~   "
39140|NCT03054350|"~     This is a Phase 2, randomized, double-blind, placebo-controlled, dose-finding study to assess~     the efficacy, safety, tolerability, PK, and PD of orally administered vadadustat in Japanese~     subjects with anemia secondary to DD-CKD.~   "
39141|NCT03054337|"~     This is a Phase 2, randomized, double-blind, placebo-controlled, dose-finding study to assess~     the efficacy, safety, tolerability, PK, and PD of orally administered vadadustat in Japanese~     subjects with anemia secondary to NDD-CKD.~   "
39142|NCT03054324|"~     Coronary fraction flow reserve (FFR), the ratio of the mean coronary pressure distal to a~     coronary stenosis to the mean aortic pressure during maximal coronary blood flow (hyperemia),~     defines the hemodynamic significance of coronary artery narrowing. Noninvasive assessment of~     FFR via a combination of computational fluid dynamics (CFD) and coronary CT angiography CCTA~     (the so-called FFRCT) has potential. Coronary computed tomographic angiography is a~     noninvasive test for diagnosis of anatomic coronary stenosis (i.e., narrowing of a blood~     vessel). A new analytical model of FFR from the general Bernoulli equation (conservation of~     energy) (FFRB) is simple and has potential. A collaborator group has recently developed a new~     analytical model to quantify pressure drop, and hence FFR, based on lesion dimensions (i.e.,~     the cross-section area along the lesion and the length of lesion) and coronary flow, with no~     empirical parameters. The investigators hypothesize that this new model will allow~     quantification of FFR (FFRB) in a cohort of human patients with intermediate coronary~     stenosis. The study will compare FFRB with invasive FFR measurements from invasive coronary~     angiography (ICAG).~   "
39166|NCT03054012|"~     Background:~      Functional and aesthetic reconstruction of mandibular defects due to tumour invasion,~     osteoradio- or chemonecrosis or trauma are challenging. Surgeons aim to achieve a good~     anatomic and symmetric reconstruction with stable occlusion and condylar position.~     Classically this was obtained by (pre)bending a reconstruction plate, and providing~     osteotomies at the vascularized free flap. Today there is the availability of CAD-CAM~     software enabling a preoperative planning based on 3D models. This computer-assisted surgery~     (CAS) procedure is said to improve accuracy of the postoperative result, as well as a reduce~     ischemia time. However, there is a need for objective analysis of the accuracy of CAS, as~     well as the effective reduction in operating time and financial implication.~      Study design:~      Retrospective study.~      All patients undergoing bony reconstruction by free vascularised flap between January 2013~     and August 2016 will be included. Accuracy will be measured between the planned and actual~     result, through segmentation of the mandible in Brainlab software. Parameters regarding~     ischemic time and financial cost will be obtained from the medical files.~   "
39167|NCT03053999|"~     The study aims to identify predictors of disease in patients with hyperparathyroidism (HPTH)~     who undergo surgery.~   "
39143|NCT03054311|"~     Lifestyle Matters is an occupational approach to healthy ageing, which helps older people to~     get the most out of life. The intervention is based on an American model of health promotion~     called Lifestyle Redesign. This was found to be highly effective in enhancing the physical~     and mental health, occupational functioning and life satisfaction of community living older~     adults in Los Angeles, USA.~      Weekly group meetings provide older people with the space, time and opportunity to share~     their experiences. Through a process of peer exchange and guidance, participants have the~     opportunity to reflect upon the range of activities that they engage with. They are then~     helped to begin to understand how these activities might impact on their health and~     well-being. However this approach alone cannot meet the complex needs of individual older~     people, and their specific and personal concerns. In recognition of this, the programme also~     includes monthly individual sessions with one of the group facilitators. The older person in~     partnership with the facilitator identifies a tailored programme to meet their individual~     needs, including the means by which they might work towards their personal goals. The~     individual programme is updated and refreshed in subsequent meetings over the months.~      During 2004/5 researchers at Sheffield Hallam University in partnership with other~     researchers in York and Leeds, and clinical colleagues in Sheffield explored the feasibility~     of delivering this intervention to older people living in the UK. The project was funded~     through the Sheffield Health and Social Research Consortium. The summary below is an account~     of the process and outcomes of delivering a Lifestyle Matters programme to two groups of~     community living older people during 2004/5.~   "
39144|NCT03054298|"~     Phase I study to establish safety and feasibility of intravenous or intrapleural administered~     lentiviral transduced huCART-meso cells with or without lymphodepletion. Intravenous~     administration of huCART-meso cells is planned with or without cyclophosphamide as~     lymphodepleting chemotherapy.~   "
39145|NCT03054285|"~     The primary objective of this study is to prospectively assess in randomized fashion whether~     short term anti-seizure prophylaxis in traumatic brain injured patients decreases the~     incidence of seizures in the early post-injury period. A secondary objective is to evaluate~     whether there are differences in mortality, hospital length of stay, functional outcome at~     hospital discharge, hospital cost, discharge status (home, rehabilitation facility, etc.) for~     patients who receive and do not receive anti-seizure prophylaxis.~   "
39146|NCT03054272|"~     Using eye-tracking technology, the aim of this observational study is to compare the visual~     interests between attending physicians and residents watching a Cannot Intubate/Cannot~     Oxygenate (CICO) scripted and simulated scenario~   "
39147|NCT03054259|"~     This is a feasibility study to test a new trial design for an important drug in Systemic~     Lupus Erythematosus (SLE or lupus).~      SLE is an autoimmune disease. The immune system attacks the body's own tissues, any part of~     the body may be affected, but most commonly lupus causes a rash and arthritis, this affects~     patients' quality of life.~      Lupus is usually treated with steroids or drugs that suppress the immune system. Although~     these help, many patients don't respond well enough and there is also concern for long term~     side effects. There is a new type of treatment called biologics. These target individual~     cells or molecules rather than the whole immune system and may be more effective with fewer~     side-effects. B cells are a part of the immune system that are known to play a role in lupus.~     There is already a biologic that removes these, called rituximab. In rheumatoid arthritis and~     vasculitis (similar to lupus), rituximab has been proven to be effective in clinical trials.~     However, in lupus clinical trials it did not seem to show any benefit. But many doctors and~     patients found that rituximab is effective, but the trials couldn't show this because of the~     way the drug's effects were measured. Therefore it is important that we test whether it truly~     is effective for lupus.~      In this 6 month clinical study the investigators will look at lupus patients who have skin~     disease and arthritis as these are very common and randomise them to receive either rituximab~     or a placebo. Patients will have a careful clinical examination and undergo different methods~     to measure the effectiveness of the treatment. There are new versions to rituximab called~     biosimilars. In this study biosimilar GP2013 will be used.~      If this trial is successful a larger definitive study will be designed based on its results.~   "
39148|NCT03054246|"~     The study is aimed to investigate if chewing side preference (CSP) can be used as another~     indicator of hemispheric laterality in healthy adults. Healthy volunteers with no oral/dental~     problems with Angle I occlusion relationship and without any missing teeth will be included~     in the study. The CSP will be determined with the visual analog scale (VAS), which is the~     highly reliable method. Laterality test will be used to determine the preferred side for~     hands, feet, ears and eyes.~   "
39149|NCT03054233|"~     The study aimed to compare successful spinal needle insertion between obese and non-obese~     pregnant women in crossed leg sitting position undergoing cesarean section~   "
39150|NCT03054220|"~     CYP2D6 is characterized by a huge variability in the general population, mainly because of~     genetic polymorphism and drug-drug interactions (DDIs). CYP2D6 genotype is known to have an~     impact on the extent of DDIs. Indeed several studies have pointed out differential DDIs~     extent according to CYP2D6 genotype. The terms phenoconversion and phenotype switch are both~     used to describe the phenomenon by which a given subject changes his phenotype to another due~     external influence such as DDIs. When given a sufficiently strong CYP2D6 inhibitor, the~     phenotype of an individual with no mutant allele (extensive metabolizer, EM) of CYP2D6 can be~     modified to a poor metabolizer (PM) phenotype. This vulnerability is also thought to be~     dependent on CYP2D6 genotype. Various combinations of alleles predict an EM genotype, which~     represents about 60 to 70% of the general population. The aim of the study is to determine~     whether the presence of genetic mutation in CYP2D6 has an impact on DDIs involving the CYP2D6~     enzyme. Our interest focuses on CYP2D6 EM carriers of two fully functional alleles and~     carriers of one non-functional and one functional allele. In order to elucidate this~     question, CYP2D6 activity will be measured on healthy volunteers by administration of single~     low doses of dextromethorphan and tramadol in presence or not of duloxetine and paroxetine,~     two known CYP2D6 inhibitors.~   "
39208|NCT03053466|"~     The purpose of this study is to determine the safety, tolerability, and recommended dose of~     CBT-501 in individuals with advanced or relapsed or recurrent solid tumors.~   "
44625|NCT02982707|"~     A single oral dose of BMS-986177administered to subjects of mild hepatic impairment, moderate~     hepatic impairment and healthy matched subjects to evaluate pharmacokinetics, safety, and~     tolerability in these subjects~   "
39151|NCT03054207|"~     HIV patients are at particular risk to develop cardiovascular disease (CVD) as they exhibit~     multiple risk factors by the nature of their pathology. In addition, the long term exposition~     to antiretroviral drugs has been associated to an increased risk for CVD. HIV patients can~     thus potentially receive antiplatelet therapy concomitantly with their antiretroviral~     treatment. Clopidogrel and prasugrel are thienopyridine antiplatelet agents indicated to~     prevent the recurrence of ischemic events after coronary arteries stenting. These pro-drugs~     are mainly bioactivated by cytochromes P450 (CYP) 3A and 2B6 for prasugrel and CYP2C19, CYP3A~     and CYP2B6 for clopidogrel. Ritonavir is commonly used to boost the bioavailability of~     other HIV drugs through inhibition of CYP3A4 as well as CYP2B6 and CYP2C9. This interaction~     could therefore reduce clopidogrel and prasugrel efficacy by reducing the formation of their~     active metabolites. The aim of the present study is to assess the potential drug-drug~     interaction between clopidogrel/prasugrel and ritonavir. Two groups of 12 male subjects will~     be constituted (12 HIV patients under ritonavir boosted therapy and 12 healthy volunteers) in~     a randomized cross-over clinical trial. All subjects will also be genotyped for the CYP2C19.~     The pharmacokinetics of clopidogrel active metabolite and prasugrel active metabolite will be~     assessed. Furthermore, the pharmacodynamic response will be evaluated by two gold standard~     platelet inhibition tests, namely VAsodilator-Stimulated Phosphoprotein Assay (VASP) and~     VerifyNow® assays. The primary endpoint of this study is to compare the pharmacodynamic~     response to clopidogrel and prasugrel in HIV patients to that of healthy volunteers.~   "
39152|NCT03054194|"~     Study E2730-A001-001 is a first-in-human, sequential ascending single dose,~     placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics (PK) of a~     single oral dose of E2730 in healthy participants.~   "
39153|NCT03054181|"~     Long-term observational study on the utilisation and outcomes of HyQvia (a product consisting~     of recombinant human hyaluronidase and a human normal immunoglobulin 10% solution) under~     everyday clinical practice conditions.~   "
39154|NCT03054168|"~     This study evaluates the effect of increase in testosterone levels in older males and the~     effects of decrease in testosterone levels in young males on muscle protein synthesis.~   "
39155|NCT03054155|"~     Patients with bilateral hidradenitis in the axilla, groin and/or inframammary will be treated~     on one side with the Alexandrite hair removal laser. The other side will serve as the~     control.~   "
39156|NCT03054142|"~     Acute kidney injury (AKI) is a common clinical syndrome, especially patients in the hospital.~     AKI has become a huge medical burden in China. Little information is available about this~     disease burden in our country. The investigators aimed to evaluate the burden of AKI and to~     analyze the related risk factors.~   "
39157|NCT03054129|"~     The purpose of the study is to determine whether balance training is effective in patients~     with rotator cuff disease.~   "
39158|NCT03054116|"~     In a prospective, observational study the investigators compared resistance values measured~     using the airway perturbation device (APD) to impulse oscillometry and spirometry. The~     investigators also created reference equations for normal APD resistance ranges using the~     data from clinically normal volunteers.~   "
39159|NCT03054103|"~     Background: Phacoemulsification is the most common surgical procedure performed in the United~     States and European Union and sedation is commonly used during phacoemulsification to help~     alleviate patient anxiety and prevent the patient from interfering with the procedure. The~     investigators have administered ketamine in addition to midazolam in this regard. To study~     the effectiveness of this technique, The investigators proposed a study to determine if~     adding low-dose ketamine to midazolam has any beneficial (or negative) effects on operating~     conditions, patient satisfaction, and recovery during and after unilateral~     phacoemulsification procedures performed using topical anesthesia and intravenous (IV)~     conscious sedation.~      Methods: In a free-standing Outpatient Surgery Center, the investigators conducted a~     randomized, double-masked, 3-arm, prospective comparison of IV midazolam only vs. midazolam~     with ketamine 5 mg IV vs. midazolam with ketamine 10 mg IV. The investigators then measured a~     single surgeon's assessment of surgical conditions, self-reported patient satisfaction,~     postoperative pain score, and duration of postoperative stay. The investigators also analyzed~     the dose of midazolam required to meet subjective anxiolysis in each group.~   "
39160|NCT03054090|"~     Most care for chronic conditions is provided by primary care clinicians. Although Virginia~     ranks 4th among the 50 states in average income, it ranks 27th in mortality due to heart~     attacks and strokes. The scope and focus of this project will materially improve the rates of~     screening and treatment of risk factors for heart attacks and strokes, and will give primary~     care clinicians the tools and training to improve the care of other chronic illnesses and the~     delivery of preventive services.~   "
39161|NCT03054077|"~     This is a small pilot, feasibility study designed as a quality improvement project. The~     purpose is to identify anxiety in children aged 4-12 years who will receive a sedated~     procedure and to see if the use of an iPad as a focused activity will decrease the level of~     anxiety through a small randomized control trial in the Children's Perioperative Unit.~   "
39162|NCT03054064|"~     The purpose of this study is to evaluate the safety and effectiveness of the Indego~     exoskeleton as a gait training tool for individuals with hemiplegia due to Cerebrovascular~     Accident (CVA).~   "
39163|NCT03054051|"~     This project will test the feasibility of an electronic game to prevent HIV among African~     preadolescents, delivered via inexpensive Android smart phones. In order to collect~     feasibility data for a future randomized controlled trial, this study involves the~     pilot-testing of the intervention with a sample of young people in Nyanza region, Kenya,~     where 11.4% of young women ages 15-24 are HIV-infected. This feasibility study will be~     carried out with the Kenya Medical Research Institute (KEMRI).~   "
39164|NCT03054038|"~     This phase I trial studies the side effects and best dose of afatinib and necitumumab and to~     see how well they work in treating patients with EGFR mutation positive non-small cell lung~     cancer that has spread to other places in the body. Afatinib may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as~     necitumumab, may interfere with the ability of tumor cells to grow and spread. Giving~     afatinib and necitumumab may work better in treating patients with EGFR mutation positive~     non-small cell lung cancer.~   "
39168|NCT03053986|"~     Apple polyphenols are mostly acknowledged for their hypoglycaemic properties, but represent~     an apple active fraction with many pharmacological functions. The study aim was to examine~     their effect on uricemia and endothelial function in a sample of overweight subjects. This~     was a two-phases study. The in vitro experiment aimed to evaluate the apple polyphenols'~     ability to lower uric acid in comparison with allopurinol. The in vivo study consisted in a~     randomized, double-blind, parallel placebo-controlled clinical trial involving 62 overweight~     volunteers with suboptimal values of fasting plasma glucose (100 mg/dL≤FPG≤125 mg/dL),~     randomized to be treated with 300 mg apple polyphenols or placebo for 8 weeks.~   "
39169|NCT03053973|"~     Rationale:~      Application of long-term non-invasive ventilation (NIV) in chronic obstructive pulmonary~     disease (COPD) patients with chronic hypercapnic respiratory failure (CHRF) has recently been~     shown to improve outcomes. However, the mechanism behind these improvements are unknown. We~     hypothesize that NIV stabilizes FEV1 via beneficial effects on inflammation and repair~     pathways in patients with COPD. In the present study we aim to investigate, in COPD patients~     with CHRF,~        1. change in FEV1 after 3 months nocturnal NIV in stable hypercapnic COPD patients as~          compared to standard care~        2. the relationship between FEV1 change and modification of systemic and airway~          inflammation and remodelling, lung hyperinflation, and airway morphology.~        3. predictors of a favourable response to chronic NIV in COPD patients with CHRF. Study~          design: multicentre randomised controlled study investigating the effects of NIV on~          airway morphology, airway inflammation and remodelling in hypercapnic COPD patients~          including a control group that will postpone the initiation of NIV for 3 months. In~          addition we will investigate how patient demographics, patient and disease~          characteristics and systemic and airway inflammation predict the response to chronic NIV~          in severe stable COPD. To do this, all patients will be followed for 6 months after NIV~          initiation.~      Main study parameters/endpoints: The main endpoint is the change FEV1 after 3 months.~     Furthermore, as we recognise that FEV1 might not be the most important patient-related~     outcome, we will assess which parameters affect health-related quality of life after 3 and 6~     months.~   "
39170|NCT03053960|"~     This clinical trial studies how well helical computed tomography (CT), positron emission~     tomography (PET)/CT, magnetic resonance imaging (MRI), and cone beam computed tomography~     (CBCT) work alone or in combination in predicting whether tumor cells have spread to the jaw~     bone (jaw invasion) in patients with oral cancer. Imaging, such as helical CT, PET/CT, MRI,~     and CBCT, may help find out how far cancer has spread. Accurate prediction of the presence or~     absence of jaw invasion may help create a better surgical treatment plan for patients with~     oral cancer.~   "
39171|NCT03053947|"~     Lacerations are one of most common trauma in children presenting to the emergency department~     (ED). Currently, there are wide variations regarding sedation and analgesia practices when~     suture are required. Even though topical anesthesia is very useful to reduce pain, it does~     not obviate the use of pharmacologic agents to decrease stress in anxious children undergoing~     laceration repairs in the ED.~      There is a growing interest in the intranasal (IN) route of administration in the pediatric~     population. It bypasses the first hepatic passage and thus provides medications direct access~     to the systemic circulation leading to higher and faster serum concentrations than would the~     oral route. Also, intravenous (IV) cannulation can be avoided reducing the pain associated~     with it and the need for nursing time and procedure delay. IN fentanyl and midazolam are two~     agents that can be combined for this procedure, but respiratory depression is a feared~     adverse effects. Ketamine is the most commonly used IV agent for procedural sedation, and can~     offer potent analgesia and sedation while maintaining respiratory drive and protective airway~     reflexes. Few studies have evaluated IN ketamine for procedural sedation. There is a wide~     range of dosing reported from 3 to 9 mg/kg. This raises the question as what is the lowest~     possible dosage that can be used to successfully repairs laceration in children with minimal~     restrain and no adverse events, as described by the Pediatric Emergency Research Canada~     (PERC)/ Pediatric Emergency Care Applied Research Network (PECARN) consensus.~   "
39172|NCT03053934|"~     The objective of the study is to establish whether online video counselling is at least~     equally acceptable and equally as effective to clients and clinicians of the Veterans and~     Veterans Families Counselling Service (VVCS) as in-person counselling. If this is confirmed~     by the evaluation then online video counselling can be made more widely available to support~     the veteran and ex-service community, especially for those who may otherwise be unable to~     attend therapy and for clients who would prefer such web-based services over in-person~     sessions.~   "
39173|NCT03053921|"~     Aim of the study was to evaluate the clinical efficacy of placental membrane with coronally~     advanced flap in covering single and multiple Miller's class I and II gingival recession~     defects.~   "
39174|NCT03053908|"~     Alzheimer's disease (AD) is a common neurodegenerative disease characterized by the~     accumulation of amyloid plaques and neurofibrillary tangles. Current consensus is that the AD~     pathological process begins decades before clinical symptoms occur. This long preclinical~     phase of AD might first become detectable in middle-age as deposits of hyperphosphorylated~     tau (P-tau) in the transentorhinal cortex and subcortical nuclei such as the locus coeruleus~     (LC) and the nucleus basalis of Meynert. There is strong preliminary evidence showing that~     cerebrospinal fluid (CSF) levels of orexin-A (OxA) are associated with increased P-tau~     (r=.52, p<.01) and total-tau (T-tau) (r=.42, p<.01) in cognitively normal older adults (mean~     age: 69.6±8.6 years).~      This study poses that onset of tauopathy in the LC results in down regulation of orexin~     receptors, leading to a homeostatic increase of OxA production by the hypothalamus, which~     results in changes in core body temperature (CBT) and sleep disruption that cause further~     neurodegeneration. This hypothesis will be tested by demonstrating that increases in CSF~     P-tau are associated in vivo with tau PET uptake, and that tau binding in the LC is~     associated with increases in CSF OxA (Aim 1); and second, by analyzing the downstream~     consequences of increased central nervous system (CNS) OxA on sleep architecture and CBT (Aim~     2). To test these hypotheses, 19 older adults (age 55-75) balanced by sex, will first perform~     a full clinical evaluation and PET-MRI where Tau burden will be analyzed by PET-MR using~     18F-MK6240 (visits 1-2). Subjects will later undergo 7 days of actigraphy followed by~     nocturnal polysomnography (NPSG) for 2 consecutive nights (N1-2) during which we will measure~     CBT (visits 3-4). A morning lumbar puncture (LP) will be performed after N2 to obtain CSF.~   "
39175|NCT03053895|"~     DECIDE (Bedside versus Operating Room Burr-Hole DrainagE of ChronIc SubDural HEmatoma)~      CSDH is an abnormal collection of blood between the layers of the brain causing brain tissue~     compression leading to neurological complications. One of the most common risk factors~     contributing to CSDH is head trauma, which is usually in the form of a minor head injury.~     Older individuals are at increased risk of CSDH due to brain atrophy that occurs with~     advancing age as well as their tendency to fall and sustain minor head traumas. Chronic~     alcoholics are also at increased risk as alcoholism also leads to brain atrophy, increased~     risk of falls, and liver failure which results in increased bleeding risk. Also many drugs~     used today like anticoagulants, antithrombotics, and antiplatelets for certain health~     conditions are other common risk factors for CSDH.~      The overall goal of this multi-centered trial in the USA and Canada is to assess the surgical~     management of chronic subdural hematoma (CSDH) and to demonstrate the effectiveness of~     bedside drainage and its safety as it bypasses the perioperative risk associated with~     anesthetic especially among the elderly.~      Adult patients with a clear indication for CSDH drainage will be randomly assigned to one of~     two procedures. One group will receive the twist drill procedure which can be performed at~     the bedside. The second group will undergo the burr-hole drainage procedure in the operating~     room usually under general anesthetic. Typically, the twist drill procedure can occur sooner~     as the operating room and Anesthetist are not required. Reoccurrence of the CSDH will be~     assessed over a period of 6 months following drainage. Timing of procedure, risk of~     infection, adverse side effects and neurological functioning will also be measured.~      Over a 3 year study period, 486 eligible patients (243 patients per arm) will be enrolled.~     Patients > 18 years with confirmed diagnosis of symptomatic CSDH will be provided one of the~     two procedures and will be followed for study outcomes at 1, 3 and 6 months following the~     procedure.~      Primary analysis will be to compare the surgical procedures, assessing the recurrence rate of~     CSDH within 6 months of initial CSDH drainage.~      The ultimate goal of this study is to standardize bedside drainage as the treatment of choice~     for CSDH management.~      This trial is important in the ongoing search for more efficient and safe intervention~     strategies.~   "
39176|NCT03053882|"~     Background:~      Herbal remedies can have the role of prevention and control of bad breath Since in the~     previous studies, therapeutic and antibacterial effect of green tea and peppermint had been~     proven .we studied and compared the effects of green tea and peppermint mouthwashes on~     halitosis.~      Materials and Methods:~      This single-blind clinical trial study with cross over design total of 88 volunteer dental~     students who complained bad breath and had organoleptic score (>= 2) and higher average test~     scores were enrolled. The students were divided randomly into two groups Green Tea -~     Peppermint were assigned. Organoleptic test in the baseline, on the 7 day, 14 and 21 measured~     after rinsing the mouthwashes .As well as the satisfaction of both plants on the last day was~     considered. Data analysis was performed using tests; Wilcoxon signed rank test, Mann Whithney~     u, GEE (Generalized Estimating Equation -ordinal logistic regression).~   "
39177|NCT03053869|"~     The purpose of this two-centre pilot research study is to establish the feasibility of~     conducting a full trial that seeks to determine if a cardiac anesthesia policy that uses~     alternatives to benzodiazepine medications is better at preventing delirium after cardiac~     surgery when compared with a cardiac anesthesia policy that uses benzodiazepine medications.~   "
39178|NCT03053856|"~     This is a single arm, single center phase II study of adjuvant pembrolizumab in N2 positive~     non-small cell lung cancer (NSCLC) patients treated with neoadjuvant concurrent~     chemoradiotherapy followed by curative resection. Patients will receive pembrolizumab 200 mg~     every 3 weeks for up to 24 months.~      The primary objective of this study is to assess the efficacy of adjuvant pembrolizumab~     treatment in terms of disease-free survival (DFS; per Response Evaluation Criteria In Solid~     Tumors (RECIST) 1.1 as assessed by the investigator).~      The baseline assessment is part of the screening procedures and should be performed within 0~     to 14 days before the start of study drug. The imaging modalities used for RECIST 1.1~     assessment will be CT of chest or PET-CT if indicated. Follow-up chest CT for all patients~     will be assessed every 12 weeks for the first year, every 16 weeks for the second year, every~     6 months for the third year, and every year thereafter. In subjects who discontinued study~     therapy without documented recurrence, every effort should be made to continue monitoring~     their disease status.~      If an unscheduled assessment is performed, and the patient has not progressed, every attempt~     should be made to perform the subsequent assessments at their scheduled visits. RECIST 1.1~     scans will be analyzed by the investigator on site; a central review will not be conducted.~      Following completion or discontinuation of study drug, patients will enter a follow-up~     period.~      Once a patient has had objective relapse recorded and has discontinued study drug, the~     patient will be followed for survival status every 3 months until death, withdrawal of~     consent or the end of the study.~      Patients will also be requested to provide tumor samples from diagnostic (obtained before~     neoadjuvant CCRT) and surgical specimens for exploratory biomarker study. Sample provision is~     not optional, subject to a specific consent.~   "
39179|NCT03053843|"~     Background: Atrial fibrillation (AF) is the most frequent cardiac arrhythmia and represents a~     high priority public health problem, as in a few decades it will become a possibly~     unsustainable load for the national health system. Preventive and therapeutic strategies~     based on the best possible scientific evidence are required. Ablation therapy, despite being~     the most effective approach, is associated with a 30-35% arrhythmic recurrence rate. An~     intervention with Mediterranean diet and extra virgin olive oil (EVOO) has proven effective~     in primary prevention and reduced the incidence of AF in high-risk subjects in a recent,~     large, randomized trial (PREDIMED).~      Methods: Parallel, randomized, multicenter nutritional intervention trial in 640 patients~     with AF treated with catheter ablation. Two groups will be randomized in a 1:1 ratio: 1)~     intervention with Mediterranean diet and EVOO; 2) usual care (control group). The primary~     objective will be the incidence of atrial tachyarrhythmias for two years after ablation. At~     least 190 recurrences are expected after 2 years (median) of follow-up. A relative risk of~     0.7 is assumed and statistical power of 80%. Follow-up visits will be scheduled at 3, 6, 12,~     18 and 24 months. In addition to the in-person visits, event monitors will be used to~     document episodes. Dietary intervention will be carried out by nutritionists who will use~     methods adapted from the PREDIMED trial with contacts every 2 months. 1 liter of EVOO per~     week will be provided for free in the intervention arm. Inflammatory markers will be analyzed~     in both groups during follow-up. Cox models will be used to estimate adjusted hazard ratios.~   "
39180|NCT03053830|"~     Medically healthy Veterans ages 21-75 that have been diagnosed with Depression will get up to~     6 treatments of Ketamine infusions, weekly. After treatment is completed, follow up will~     occur at 1 month, 3 months, and 6 months after completion of infusions to evaluate the longer~     term effects of ketamine.~   "
39181|NCT03053817|"~     Exercise programs that combine resistance exercise with aerobic training yield optimal health~     benefits for people with HIV. The global aim of this study is to contribute evidence for the~     impact potential of a comprehensive exercise program on brain health in people with HIV.~      This study is part of a larger project based upon a cohort multiple randomized controlled~     design. Within a fully characterized cohort which is followed over time, people meeting the~     specific criteria for an exercise intervention will be identified. The sample will be~     randomly selected to receive the intervention; the remaining eligible persons will serve as~     controls. The intervention group will receive a 45 minute structured exercise program 3 times~     a week consisting of aerobic exercise and resistance training for a total of 12 weeks.~   "
39182|NCT03053804|"~     It is a study that hypothesize that MR/PET can have better information than current CT image~     study, about the medical or surgical treatment outcome of lung cancer~   "
39183|NCT03053791|"~     Spinal cord injuries are anatomically mostly incomplete, showing tissue bridges of the spinal~     cord at the injury site. Of the 60% functionally incomplete patients, about half face a life~     in the wheelchair. Besides conventional rehabilitation, no prominsing further treatment~     options exist. One of the most plastic systems involved in locomotion is the pontomedullary~     reticulospinal tract, which is the oldest locomotor command system existing in most~     vertebrates, including primates. Muscle activation patterns for limb movements are programmed~     in the spinal cord and have to be activated and coordinated through commands from the so~     called mesencephalic locomotor region (MLR). The MLR consists of nerve cells in the lower~     mesencephalic tegmentum sending uni- and bilateral signals through the medullary~     reticulospinal tracts. Classical physiological studies showed that electrical stimulation of~     the MLR induce locomotion. For the first time this approach was transferred and recently~     published in a model of induced incomplete spinal cord injury by the Schwab group. Rats~     severly impaired in motor hindlimb control with only 10-20% spared white matter, recovered~     with fully functional weight bearing locomotion under MLR deep brain stimulation (DBS). Even~     rats with only 2-10% spared white matter regained weight supporting stepping. DBS is a~     clinical standard treatment option in patients with movement disorders but does not relieve~     all symptoms. Therefore, small studies of MLR stimulations have been safely used in~     Parkinsonian patients showing freezing of gait and frequent falls with variable results. In a~     translational approach, we aim at performing a multidisciplinary phase one clinical trial~     with 5 patients and incomplete spinal cord injury. With the means of our established~     universitary setup for DBS treatments the operations will be performed unilaterally under~     local anaesthesia in the Division of Neurosurgery, USZ, with perioperative~     electrophysiological recordings, clinical assessments and gait analysis under test~     stimulation in the Spinal Cord Injury Center Balgrist.~   "
39184|NCT03053778|"~     This study aims to investigate the effect of an intervention consisting of early,~     individualised outpatient follow-up after heart valve surgery on unplanned readmissions and~     death within 180-days after discharge.~      Furthermore, Health economics and health-related quality of life will be investigated.~   "
39185|NCT03053765|"~     The study is designed to develop and validate an instrument to measure quality and adherence~     to IPT for research and training purposes. The measure is now being used to evaluate training~     in IPT.~   "
39186|NCT03053752|"~     Sleep disorders are among the non-motor signs more common in Parkinson's disease (PD). This~     case series evaluated the effects of Transcutaneous Electrical Nerve Stimulation (TENS) on~     acupoints in the self-assessment of sleep in 14 PD patients classified between stages 1 and 3~     of Hoehn and Yahr original (HY). Patients were assessed using the Sleep Scale for Parkinson's~     Disease (PDSS) and subjected to treatment with eight TENS sessions on acupoints, with the~     current Burst. We used the paired sample t-test, considering p ≤ 0.05.~   "
39187|NCT03053739|"~     The study will be carried out on 50 consecutive consenting patients of systemic sclerosis~     with PAH recruited from outpatient department of internal medicine and rheumatology clinic of~     PGIMER, Chandigarh, India It is a single centre double blind randomised controlled trial~     evaluating the effect of upfront dual therapy (sildenafil and bosentan) vs monotherapy~     (sildenafil) Participants will be randomised in 1:1 ratio to one of treatment arms. Placebo~     and PDE-5 inhibitors 20 mg BD to 60 mg if patient tolerates the drug well to one study arm~     and PDE-5 inhibitors plus ER antagonist 62.5 to max of 125 to other study group~   "
39188|NCT03053726|"~     In the VFS paradigm the stimulation frequency was set to alternate between high and low~     frequencies, where the frequency of stimulation or frequency combinations can be changed~     instantaneously according to damage of the moment rhythms. Variable frequency stimulation is~     a novel dynamic therapy which breaks through the existing single high-frequency stimulation~     paradigms. It is the world's first VFS therapy for the brain.~   "
39189|NCT03053713|"~     The Mediterranean Diet Pattern (MDP) has been shown to have beneficial effects on the~     intestinal bacteria and the immune system in diseases like cancer and diabetes. The aim of~     this study is to determine if a MDP will have an impact on symptoms, intestinal bacteria and~     the immune system in Ulcerative Colitis (UC). Symptoms, blood and stool will be examined to~     determine if the MDP results in changes to the intestinal bacteria or immune system.~   "
39190|NCT03053700|"~     This is an interventional and prospective study. The study is designed to evaluate the~     additional benefits of a combination of IPL treatment and local application of Bromonide~     0.33% gel in the treatment of erythematotelangiectatic (ETR) and papulopustular (PPR).~   "
39191|NCT03053687|"~     The Proposed study is a double blind, randomized, placebo controlled study The aim of the~     study is to evaluate the effect of combined Growth Hormone (GH) treatment & nutritional~     formula supplementation versus GH & placebo on growth parameters in 64 children with Isolated~     Growth Hormone Deficiency (IGHD) after the 2nd year of GH treatment.~      In this trial GH is a background treatment (non-investigational medicinal product.~     Participants may be treated with any of the commercial GH products approved in Israel for the~     indication of IGHD.~      Participants will be randomly assigned either to the intervention group or the placebo~     control group. Randomization for the two study groups will be made in a ratio of 1:1. Both~     participants and study team will be blinded to the type of treatment that each patient will~     receive during the study. The randomization will be done according to gender and tanner~     stage.~      Participants in the intervention groups will be treated with the study formulas and~     participants in the control group will be treated with a placebo low caloric formulas (Powder~     added to water) The study will continue for 6 months of intervention versus active placebo,~     with additional 6 months (an extension period), in which participants at both groups, the~     intervention and the placebo, will be offered to continue their participation in the study~     with the active study supplement.~   "
39192|NCT03053674|"~     The aim of this study is to determine whether an explanation to parents for the need for~     post-partum influenza vaccination will influence their compliance.~   "
39193|NCT03053661|"~     The IRECT trial is a non-interventional, prospective clinical trial using modern immune~     monitoring techniques over the course of the standard of care for HNSCC. The dynamics of~     host/tumor immune interactions during the conventional standard treatment will be analyzed to~     find the most promising target antigen and to develop a strategy how and when specific~     immunotherapy should be added to the current treatment schedule.~      The results from this trial will help to understand how state of the art treatment can be~     complemented using cancer-testis antigen specific vaccines and immune-modulating drugs to~     improve the outcome of head and neck cancer patients.~   "
39209|NCT03053453|"~     The purpose of this study will be to evaluate and compare patients undergoing total knee~     arthroplasty (TKA) with sensor guidance versus that of a standard technique. Each patient~     will be assessed for the difference between passive, soft tissue controlled, pressure balance~     and muscle activated pressure balance.~   "
39210|NCT03053440|"~     This study is to evaluate the safety, efficacy and clinical benefit of BGB-3111 vs ibrutinib~     in subjects with MYD88 Mutation Waldenström's Macroglobulinemia.~   "
39194|NCT03053648|"~     Abstract~      Objectives: To explore the clinical effects of self-acupressure for treating insomnia~     delivered by a training course.~      Hypothesis: Subjects who have participated in the self-acupressure training course will have~     greater improvement in insomnia symptoms and daytime impairment than the sleep hygiene~     education control group at 4 and 8 weeks.~      Design and subjects: A pilot randomized controlled trial. Subjects with insomnia will be~     recruited from the community. 30 subjects will be randomized to self-acupressure and sleep~     hygiene education control groups in a 1: 1 ratio. Study instrument: Insomnia Severity Index~     (ISI) will be used to assess insomnia symptoms and daytime impairment.~      Interventions: Subjects in the self-acupressure group will attend two training sessions to~     learn self-acupressure and will practice self-acupressure every night for 4 weeks; subjects~     in the sleep hygiene education control group will receive two training sessions to learn~     sleep hygiene practice.~      Main outcome measures: The primary outcome measure is the ISI score. Other measures include~     sleep parameters using subjective sleep diary, Hospital Anxiety and Depression Scale, and~     SF-6D at 4 and 8 weeks. Acceptability and sustainability of self-acupressure will also be~     evaluated.~      Data Analysis: Differences in the questionnaire scores, subjective sleep parameters will be~     examined using a mixed-effects model.~   "
39195|NCT03053635|"~     This is a phase Ib, open-label, single-arm, single-center study conducted in Canada. Subjects~     with NMIBC (Ta, T1, and/or Tis) who are not candidates for or have refused radical cystectomy~     will be eligible for participation in the study. Bacillus Calmette-Guerin (BCG) intolerance~     or refractory disease are defined as inability to tolerate or failure to achieve a~     tumour-free state after at least one induction (a minimum of 5 instillations) followed by~     either a second induction (a minimum of 5 instillations) or at least 2 maintenance~     instillations. Subjects experiencing disease relapse within 12 months or less after finishing~     the second course of BCG therapy are also considered refractory. The study will consist of 2~     phases. In the first phase, 3 subjects will receive PDT (TLC-3200 System) employing 0.35~     mg/cm^2 (maximum recommended starting dose) TLD1433. If treatment with the maximum~     recommended starting dose does not raise significant safety concerns as determined by the~     safety monitoring committee, an additional 6 subjects will receive PDT with 0.70 mg/cm^2~     (therapeutic dose) TLD1433.~   "
39196|NCT03053622|"~     This study is conducted to compare how much mirikizumab, in two different formulations, is~     absorbed into the bloodstream and how long the body takes to get rid of it, when given as an~     injection under the skin or into the veins. Side effects of the injection will be collected.~     Each participant will be in the study for about 18 weeks, including screening.~   "
39197|NCT03053609|"~     Cardiorespiratory and gastroesophageal reflux events often coexist in infants in Neonatal~     Intensive Care Unit (NICU) thus leading to drugs over-prescription and delayed discharge.~      Through cardiorespiratory and pH-impedance monitoring this study aims to evaluate the~     temporal association between gastroesophageal reflux (GER) and cardiorespiratory (CR) events~     in a large number of infants with gastroesophageal reflux disease (GERD) and CR symptoms and,~     whether this association is significant, to clarify the impact of GER on CR events.~   "
39198|NCT03053596|"~     The main purpose of this registry is to assess liver toxicity, treatment efficacy, and safety~     of DEB-TACE using anthracyclin loaded LifePearls for treatment of patients with unresectable~     hepatocellular carcinoma allocated to TACE treatment.~   "
39199|NCT03053583|"~     The purpose of this study is to compare straight blades in obtaining best glottic view in~     children. The investigators will compare size 1 Classical Miller, size 1 Wis-Hipple, and size~     1 C-MAC straight blades in young children.~   "
39200|NCT03053570|"~     The purpose of this study is to perform a prospective, randomised study investigating the~     safety and efficacy of cryoballoon catheter ablation compared with radiofrequency~     ablation(contact force), in the treatment of persistent AF.~   "
39201|NCT03053557|"~     This study aims to test a new device called the Social Skills Coach that is being created to~     help mental health consumers with social skills and community functioning. People diagnosed~     with schizophrenia and clinicians will be included as participants in this study. Mental~     health consumers (diagnosed with schizophrenia) will be randomly assigned to either test the~     new device or to participate in a social skills training course. Data will be collected from~     participants through surveys before participants either use the device or participate the~     course and afterwards. Individual interviews will be conducted with a sub sample of mental~     health consumers and clinicians. The study looks to test the credibility and acceptability of~     the new device to help mental health consumers and clinicians. it will also influence future~     research.~   "
39202|NCT03053544|"~     This study is a phase II, single arm, controlled, open label internal pilot.~   "
39203|NCT03053531|"~     The Hearing Resources and Outcomes in the Emergency Department Pilot (HERO-ED Pilot), gathers~     preliminary data and hones procedures and measures, prior to undertaking HERO-ED. Since the~     HERO-ED Pilot does not involve random assignment (no control group), it will not test device~     effectiveness. However, the HERO-ED Pilot will test device acceptability and use. It will~     also provide preliminary data on, and allow us to fine-tune, the measures of effectiveness~     that we plan to use in HERO-ED~   "
39204|NCT03053518|"~     This is an initial validation study of the Personal Nutrition Project (PNP) algorithm in a~     North American population with recently diagnosed Type 2 Diabetes (T2D). This is a 2-stage,~     single-group feeding study in 20 individuals, including 10 participants managed with~     lifestyle alone, and 10 managed with lifestyle plus metformin.~   "
39205|NCT03053505|"~     This study is a two-arm, interventional, prospective, open-label, multi-center clinical trial~     with randomized and non-randomized study groups to evaluate the safety and effectiveness of~     faecal microbiota transplantation (FMT) for the treatment of adult patients suffering from~     primary or recurrent Clostridium difficile infection (CDI), using a novel, standardized~     microbiota transplantation system.~   "
39206|NCT03053492|"~     This study has 2 parts: In one part of this study, people with stroke will either play a~     custom designed computer game for stroke rehabilitation called Duck Duck Punch or an off the~     shelf computer game with their weaker arm 3 times per week for 6 weeks. Evaluations will~     determine whether or not one computer game improved arm movement more than the other. In the~     second part of the study, people with stroke, caregivers of people with stroke and stroke~     rehabilitation therapists will meet in several focus groups to design a useful and~     informative Duck Duck Punch performance report.~   "
39212|NCT03053414|"~     Inflammatory bowel disease (IBD), which includes ulcerative colitis (UC) and Crohn's disease~     (CD), are chronic relapsing inflammatory conditions of the gastrointestinal tract. IBD is~     thought to result from a complex interaction between genetic, immune, microbial and~     environmental factors. There is emerging data suggesting Vitamin D may not only play a role~     in bone health but may also be involved in gut health as well. While there are guidelines~     regarding the recommending doses of Vitamin D for supplementation and maintenance in bone~     health, these strategies are unknown in those with inflammatory bowel disease. The~     investigators seek to determine a dosing strategy for this population using doses within the~     recommended guidelines for bone health.~   "
39213|NCT03053401|"~     Both Ultrasound guided Adductor Canal Block ( ACB) and Femoral Nerve Block (FNB) has been~     used to provide postoperative analgesia for knee surgeries. To the investigators' knowledge,~     no comparison has been made between these blocks in relation to postoperative quadriceps~     muscle strength, or duration and quality of postoperative analgesia for arthroscopic ACL~     repair in pediatrics. If ACB provides postoperative analgesia after arthroscopic knee surgery~     comparable to FNB, it has the potential to improve the postoperative outcome as it will lead~     to less quadriceps muscle weakness and early mobilization, both of which are very important~     in the early postoperative period.~   "
39214|NCT03053388|"~     Double blind, randomized multi-center, evaluation of the efficacy, safety and tolerability of~     Nitric Oxide (NO) given intermittently via inhalation to subjects with acute bronchiolitis.~      Bronchiolitis is defined as an infection of the small airways. It is also the most common~     manifestation of acute lower respiratory infection (ALRI) in early infancy, and is the~     leading cause of global child mortality.~      Nitric Oxide (NO) has been shown to play a critical role in various biological functions,~     including in the vasodilatation of smooth muscle, neurotransmission, regulation of wound~     healing and during immune responses to infection with a microbicidal action directed toward~     various organisms. In the airways, NO is considered to play a key role in the innate immune~     system in which the first-line of host defense against microbes is built.~      The beneficial effect of NO has been shown in different diseases with several options of~     doses and regimens; newborn with primary pulmonary hypertension showed improvement in~     oxygenation after 30 minutes of NO treatment at 10-20 ppm, while subjects with adult~     respiratory distress syndrome demonstrated clinical improvement during NO treatment at 18 and~     36 ppm.~      In vitro studies suggested that NO, in part per million (ppm) concentrations, possesses~     antimicrobial and anti-viral activity against a wide variety of phyla including bacteria,~     viruses, helminthes and parasites.~      Safety and tolerability of 160 ppm NO given intermittently via inhalation were shown in a~     phase II study performed on 2-12 month infants hospitalized with bronchiolitis. According to~     data no difference in the proportion of adverse events and serious adverse events were~     detected between subjects treated with NO and subjects treated with standard supportive~     treatment.~      In this study the investigators wish to assess the efficacy of 160 ppm NO given~     intermittently via inhalation to 0-12 months-old infants hospitalized due to acute~     bronchiolitis.~      Primary objective: Asses the difference in hospital Length of Stay (LOS) between subjects~     treated with 160 ppm NO combined with standard supportive treatment and subjects treated with~     standard supportive treatment.~      Secondary objectives: Asses the difference in the time required to achieve clinical~     improvement, a clinical score ≤5 (Modified Tal score) between subjects treated with 160 ppm~     NO combined with standard supportive treatment and subjects treated with standard supportive~     treatment. Assess the difference in the time required to achieve sustained 92% oxygen~     saturation in room air between subjects treated with 160 ppm NO combined with standard~     supportive treatment and subjects treated with standard supportive treatment. Characterize~     the safety and tolerability of 160 ppm NO intermittent inhalation treatment as measure by the~     rate of adverse events.~      In this prospective double-blind, randomized multi-Center study the investigators will enroll~     up to 120 (no less than 80) subjects aged 0-12 months-old, diagnosed with acute bronchiolitis~     and requiring in-patient hospitalization.~      Enrolled subjects will be randomized into 2 groups. Group 1 -Treatment group - Will receive~     160 ppm NO given intermittent via inhalation in addition to standard treatment for up to 5~     days. Group 2 - will receive ongoing inhalation of the standard treatment for up to 5 days.~     Between study and after completing all study inhalations the subject will continue to receive~     the standard treatment. Oxygen (O2), NO, nitrogen dioxide (NO2) and fraction of inspired~     oxygen (FiO2) delivered to the patient will be continuously monitored.~      Treatment administration: Treatment blindness will be kept by separating between un-blinded~     team members (giving the actual treatment) and blinded team members, and by hiding the NO~     container and all study related equipment behind a curtain.~      All subjects will return for follow-up visits on day 14(+5), 21(+5) days and will be~     contacted on day 30 (+5) from day of admission to the department.~   "
39215|NCT03053375|"~     This study will examine the effects of a portable of pulsed electromagnetic field (PEMF)~     device (MD Cure, Aerotel, USA) compared with a sham device on patient-reported outcomes of~     pain and function in patients with either acute/subacute or chronic low back pain (LBP).~   "
39216|NCT03053362|"~     The purpose of this study is to evaluate the sensitivity of the THINC-it tool, in measuring~     change in cognitive deficits in individuals with MDD after receiving vortioxetine.~      Vortioxetine is used in this study as an antidepressant to improve mood, cognition and~     quality of life. Cognition refers to intellectual functions such as thinking,~     understanding, learning and remembering. Vortioxetine is approved by Health Canada for the~     treatment of MDD. In addition, vortioxetine has been reported to have a beneficial effect on~     cognitive areas such as executive function, attention/speed of processing, and memory, that~     are commonly affected negatively by MDD. Vortioxetine is recognized by Health Authorities in~     the EU and many other countries as having a benefit on cognitive dysfunction (loss of~     intellectual functions) in patients with MDD.Cognitive dysfunction is a highly persistent,~     pervasive and progressive abnormality in young adults (i.e., 18-65 years) with MDD.~      It has also been shown that among adults with MDD who are gainfully employed, measures of~     cognition are a greater determinant of overall workplace performance than is total depression~     symptom severity. Several lines of evidence indicate that cognitive deficits that persist~     between episodes of depression are critical determinants of functional recovery in the~     workplace. The functional implications associated with cognitive impairment provide the~     impetus for systematic evaluation, measurement and assessment of the domains of cognition~     expected to be impaired in this patient population.~      To date, no measurement tool has been sufficiently validated and/or determined to be~     sensitive to the cognitive deficits in younger adults with MDD. Major limitations of~     available comprehensive psychometric tools include relative lack of availability, cost, lack~     of access to most healthcare providers, and above all else, the lengthy time to administer.~     Moreover, the need for a psychometrist to interpret the results adds to the complexity and~     the costliness of such an endeavor.~      It is imperative that any tool recommended for clinical utility be aligned with the busy~     nature of a high-volume clinical practice. The ideal gold standard tool for assessing the~     presence of cognitive dysfunction in MDD in the clinical environment should include, but not~     be limited to, features such as good conceptual coverage of cognitive domains affected in~     MDD, good sensitivity and reliability, and it should be relatively uninfluenced by culture~     effects and practice effects. The tool would also need to be brief, easy to administer and~     interpret, and complement busy clinical practice.~      It is anticipated that the THINC-it tool will be free of charge and downloadable from the~     THINC-it website for use in the primary care and specialty setting. The THINC-it tool will be~     accessible via computers/tablets, will take 20 minutes to self-administer in a clinical~     setting, and the performance results will be immediately available.~   "
39217|NCT03053349|"~     Ex Vivo Lung Perfusion (EVLP) appears to be an effective strategy to expand the lung donor~     pool by better evaluation and reconditioning of non standard grafts. Today, EVLP is clinical~     practice at the most active transplant centers in North America and Europe.~      The aim of this observational prospective monocentric study is to prove the safety and~     efficacy of EVLP performed in the setting of Bergamo lung transplant program.~      A statistically estimated sample size would not fit with the small numbers of Italian lung~     transplant activity, so the investigators decided to enrol 10 consecutive recipients of~     grafts subjected to EVLP.~      Non standard grafts from Brain Dead Donors (BDD) and Donors after Cardiac Death (DCD) and~     standard grafts that will undergo prolonged cold ischemic time will be selected for EVLP.~      The donor lung procurement operation will be done in the usual manner. The EVLP procedure~     will be performed in the operating theater of Papa Giovanni XXIII Hospital. The investigators~     decided to adopt Toronto protocol since it involves some lung protective strategies. EVLP~     will proceed over a period of at least 4 and not more than 6 hours.~      After 60, 120, 180 and 240 minutes from the start of EVLP the following parameters will be~     evaluated:~        -  ratio of the partial pressure of arterial oxygen to fraction of inspired oxygen~          (PO2/FiO2, mmHg)~        -  Pulmonary Vascular Resistance (PVR, dine*s/cm5)~        -  Peak Inspiratory Pressure (PIP, cmH2O) and mean airways Pressure (Pawm, cmH2O)~        -  dynamic lung Compliance (Cpldyn, ml/ cmH2O)~        -  ΔPO2 = pulmonary vein PO2 - pulmonary artery PO2 (mmHg). Moreover, after 60 and 240~          minutes from the start of EVLP a graft X-ray and a bronchoscopy will be performed.~      The lung graft will be accepted for transplantation if, after 240 minutes from the start of~     EVLP, the following conditions are fulfilled:~        -  PO2/FiO2 >350 mmHg~        -  stability or reduction of PVR compared with the measurement at the baseline assessment~          time point~        -  stability or reduction of PIP and Pawm compared with the measurement at the baseline~          assessment time point~        -  stable or better Cpldyn compared with the measurement at the baseline assessment time~          point~        -  ΔPO2 >400 mmHg~        -  improvement of X-ray imaging compared with that at the baseline assessment time point~        -  exclusion of oedema and purulent secretions by bronchoscopy. After transplantation the~          recipients will be followed-up for 1 year according to a scheduled timetable.~      Data about the EVLP and transplant procedure and about the characteristics of donors and~     recipients will be collected in a dedicated electronic Case report form (eCRF) according to~     Good Clinical Practice.~   "
39218|NCT03053336|"~     The aim of this study is to investigate the effect of using new app-based technology to~     improve self-care, compared to usual care in patients with type 2 diabetes. The hypothesis is~     that the intervention, i.e. using the new technology, will have a greater positive effect on~     physical activity levels and outcomes of HbA1c than usual care.~   "
39219|NCT03053323|"~     The purpose of the Preconception and Pregnancy Obesity Treatment and Prevention Among Women~     with A History of Depression preliminary study is to provide a lifestyle intervention for~     women with a history of depression who are trying to conceive or are pregnant in order to~     prevent excessive pre-pregnancy weights, avoid excessive gestational weight gain, and to~     improve other markers of metabolic health. The treatment program consists of 10 private~     sessions with a trained clinician at no cost to participants.~   "
39234|NCT03053128|"~     Coronary heart disease (CHD) is a public health care challenge. There are three types of~     treatment for CHD, medication, percutaneous coronary intervention (PCI) and coronary artery~     bypass graft (CABG). However, some end-stage CHD patients lost the chance to get those~     treatment. Cardiac shock wave therapy (CSWT) is a new developed therapy for these patients,~     which is used in tens of countries all over the world. Safety, invasiveness, effectiveness is~     its advantage. Ischemia condition can be improved after CSWT. There are only three cities in~     China run the program of CSWT, which are Kunming, Beijing and Shanghai. The investigators~     designed a randomized double-blind study to evaluate the effectiveness and safety of CSWT.~   "
41009|NCT03029949|"~     The purpose of this study is to examine the effectiveness of acceptance and commitment~     therapy with vestibular rehabilitation in addition to clinical management for chronic~     dizziness, in comparison with treatment-as-usual(TAU) which is self-treatment vestibular~     rehabilitation in addition to clinical management for chronic dizziness.~   "
39220|NCT03053310|"~     Background Approximately half of head and neck cancer patients are 65 years or older at~     diagnosis. Treatment decisions in this older HNCA population are challenging, because of the~     lack of evidence-based guidelines. Surgery is often the treatment of choice in a HNCA setting~     where curative treatment is intended. Though chronological age per se has not been reported~     as a contraindication for surgery, data are limited and often the result of retrospective~     studies. Measurement of functional age, through a comprehensive geriatric assessment, has~     been suggested by several international cancer organizations to be a better prognostic~     indicator. At the divisions of maxillofacial surgery and otorhinolaryngology, a geriatric~     assessment is part of routine preoperative staging for patients of 70 years old or older.~      Objectives The investigators aim to determine the value of G8 to predict 30-day postoperative~     comorbidity in an older HNCA population undergoing elective curative surgery. Moreover, they~     aim to examine the vulnerability profile of patients undergoing elective head and neck~     surgery for an oncology diagnosis.~      Study design All patients of 70 years and older, presenting at the divisions of maxillofacial~     surgery and otorhinolaryngology for curative surgery of a solid head and neck tumour undergo~     a geriatric consult as part of routine preoperative staging. The presence of postoperative~     morbidity and mortality within the first 30 days after surgery will be collected as a primary~     endpoint.~      At 30±10 days postoperative, all patients will be re-evaluated with the G8 and the CGA.~     Patient' quality of life will also be re-examined within 30 days postoperative and again at 6~     and 12 months postoperative.~      Conclusion There is still no consensus whether older HNCA patients should receive a different~     treatment compared to younger patients. Data related to the vulnerability profile of older~     patients requiring HN surgery, and the predictive value of geriatric screening for~     postoperative morbidity could enable better patient selection in the future.~   "
39221|NCT03053297|"~     This is an observational cohort study of patients with locally advanced or metastatic NSCLC~     (non-small cell lung cancer).~      Patients will be recruited from participating sites in Europe, Asia, and Canada. The study~     will include 2 patient cohorts.~   "
39222|NCT03053284|"~     This is a small controlled pilot study to assess the effect of subcutaneous pasireotide on~     preventing hypoglycemia due to hyperinsulinism, including congenital hyperinsulinism and~     insulinoma.~   "
39223|NCT03053271|"~     This is a Phase 2 multicenter, randomized, double-blind, placebo controlled study of ATR-101~     to evaluate the efficacy and safety of orally-administered ATR-101 in adults with endogenous~     Cushing's syndrome. Following wash-out, all eligible subjects will undergo a 6-week~     open-label dose escalation with ATR-101. Subjects who continue to be eligible will then~     undergo a 4-week randomized withdrawal period. It is anticipated that the overall duration of~     the study per subject will range from approximately 14-20 weeks.~   "
39224|NCT03053258|"~     Breath samples from patients with Ventilator Acquired Pneumonia (VAP) will be analyzed to~     identify Volatile Organic Compounds (VOC) that have been specifically associated with VAP in~     previous animal models.~      Primary outcome measures will include the assessment of the zNose Diagnostic Breath Analysis~     System in the early detection of VOC's associated with VAP.~   "
39225|NCT03053245|"~     The m-CCRP randomized controlled trial will evaluate the efficacy of a collaborative critical~     care recovery program from acute respiratory failure (ARF) survivors in accomplishing the~     Institute of Healthcare Improvement's triple aims of better health, better care, at lower~     cost.~      Primary Aim:~      To assess the efficacy of m-CCRP in improving the QOL of ARF survivors compared to attention~     control at twelve months post hospital discharge.~      Secondary Aims:~        1. To evaluate the efficacy of m-CCRP in improving cognitive, physical, and psychological~          function of ARF survivors at twelve months post hospital discharge when compared to~          attention control.~        2. To evaluate the efficacy of m‐CCRP in reducing health‐care utilization, defined as time~          from enrollment to emergency department visits and/or hospital re-admission, by ARF~          survivors as compared to attention control at twelve months post hospital discharge.~   "
39226|NCT03053232|"~     Nowadays, endoscopic techniques have been applied for diagnosing and treating a variety of~     gastrointestinal diseases, such as endoscopic submucosal dissection (ESD) and endoscopic~     mucosal resection (EMR)technique for removing early gastrointestinal mucosal cancers.~     Endoscopic procedure associated gastrointestinal perforation is one of the the most severe~     complications, which is associated with high morality and needs timely detection and~     effective treatment in clinical practice.Over 90% procedure associated gastrointestinal~     perforation occurs immediately within 24 h after endoscopic procedure.Endoclips have been~     widely used in closing the immediate gastrointestinal perforations, but the location of the~     endoclips could influence the effective rate, limiting its application. In addition, multiple~     endoclips should be placed under endoscopy for a relatively large perforation, which could~     increase the medical cost and the procedure time. At recent, a new purse string suture device~     (LeoMed, China) has been developed by us and introduced to the clinicalmanagement of such~     patients with procedure associated gastrointestinal perforations. Clinical data validated~     that the usage of this new purse string suture in treating immediate procedure associated~     perforations was greatly convenient and effective with very low reoperation rate and~     postoperative complication rate. A specially designed loop was equipped in this device, which~     could be tightened under endoscopy. Thus, compared with the placement of endoclips, this~     device could be more convenient and effective in completely closing the gastrointestinal~     perforations.This study will test whether purse string suture device will increase the~     effectiveness of closingimmediate procedure associated gastrointestinal perforationsunder~     endoscopyin a randomized controlled trialby comparing the use of purse string suture~     deviceand endoclips.~   "
39227|NCT03053219|"~     The purpose of this study is to evaluate safety and efficacy of male Patients With Advanced~     NSCLC who participant in [14C] AC0010 ADME.~   "
39228|NCT03053206|"~     One-third to one-half of patients with AML relapse and in general relapsed AML patients have~     a poor prognosis. The treatment of relapsed AML consists of induction chemotherapy followed~     by Allogenic Stem Cell Transplant (ASCT). However, at present there is no standard salvage~     chemotherapy regimen for relapsed AML, as no study has shown any one regimen to be~     significantly superior. Anthracyclines, Fludarabine, Etoposide and cytarabineare active~     agents in AMLand have been used as monotherapy and in combination in refractory and relapsed~     AML patients. According to previous studies the present CR rate of different regimens ranges~     from 50-70%. A retrospective analysis (unpublished) conducted at IRCH, AIIMS on relapsed AML~     patients treated with ADE (Cytarabine, Daunorubicin and Etoposide) chemotherapy showed the CR~     rates of approximately 70%. Therefore, we have planned this study to test the efficacy and~     toxicity of ADE induction chemotherapy in relapsed AML patients in a prospective manner.~   "
39229|NCT03053193|"~     The FLEX Registry will be implemented to operate as a large-scale, population based,~     prospective registry. All patients with stage I to III breast cancer who receive MammaPrint®~     and BluePrint testing on a primary breast tumor are eligible for entry into the FLEX~     Registry, which is intended to enable additional study arms at low incremental effort and~     cost. FLEX Registry will utilize an adaptive design, where additional targeted substudies and~     arms can be added after the initial study is opened.~   "
39230|NCT03053180|"~     This prospective, multi-center, observational study is designed to assess the real world~     effectiveness and safety of paritaprevir/r - ombitasvir with dasabuvir (3DAA [direct-acting~     antiviral agent] ABBVIE REGIMEN) without ribavirin (RBV) in participants with chronic~     hepatitis C virus (HCV) genotype 1b (GT1b) infection and compensated liver cirrhosis in~     Russia.~   "
39231|NCT03053167|"~     Irinotecan and raltitrexed are active against advanced colorectal cancer (ACC), act through~     different mechanisms, and have only partially overlapping toxicity profiles. The purpose of~     this study is to evaluate efficacy and safety of irinotecan plus raltitrexed as second-line~     treatment in advanced colorectal cancer patients.~   "
39235|NCT03053115|"~     The aim of the study is to evaluate the peripheral tissue response to the combined~     administration of levothyroxine (LT4) and liothyronine (LT3) in hypothyroid patients with~     residual thyroid function virtually absent (thyroidectomized). Cases will be treated with~     LT4+LT3, at personalized doses according to clinical guidelines and respecting the circadian~     rhythmicity of LT3 and the physiological T3/T4 ratio. Controls will be treated with LT4 and~     placebo. Treatment duration: 24 weeks.~      The primary endpoint will be the peripheral effect of thyroid hormones, measuring tissue~     markers levels, such as thyroid stimulating hormone(TSH), sex hormone binding globulin~     (SHBG), total cholesterol, LDL cholesterol, lipoprotein A, osteocalcin, urinary~     N-telopeptide, ferritin, myoglobin, creatine kinase, glucose 6 phosphate dehydrogenases,~     angiotensin-converting enzyme (ACE). The secondary endpoints are bone and metabolic~     modifications, evaluated by DEXA, quality of life, tissue specific miRNA expression,~     polymorphisms of genes involved in thyroid hormones metabolism.~   "
39236|NCT03053102|"~     The purpose of this study is to determine the safety and effectiveness of ACH-0144471 in~     currently untreated patients with PNH. This study is designed to include 4 to 12 patients.~   "
39237|NCT03053089|"~     AGT-181 is a fusion protein containing alpha-L-iduronidase that is intended to deliver the~     enzyme peripherally and to the brain, when administered intravenously. This is a safety and~     tolerability study to obtain safety and exposure data as well as information on the~     biological activity of the investigational drug.~      This is a two-stage, sequential, single and multi-dose study of AGT-181 in patients with MPS~     I. The first stage will be an open-label, single-dose, dose-escalation cohort study and the~     second stage will be an open-label, multi dose, adaptive dose escalation cohort study.~   "
39238|NCT03053076|"~     To study the safety and efficacy of Autologous Umbilical Cord Blood Mononuclear Cells~     transfusion on clinical outcome in preterm infants~   "
39239|NCT03053063|"~     The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can~     cause fibrosis regression and reduce associated complications in adults with cirrhosis due to~     NASH.~   "
39240|NCT03053050|"~     The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can~     cause fibrosis regression and reduce progression to cirrhosis and associated complications in~     adults with NASH and bridging (F3) fibrosis.~   "
39241|NCT03053037|"~     This study is looking into two different ways to perform a root canal treatment. The study~     will look at differences and compare the two different treatment options over a 2-year~     period.More specifically, this study evaluates a small skinny root canal shape compared to~     a larger broad root canal shape and if this affects the success of the root canal~     treatment. Both types of treatment are standard of care and aim to treat the infection inside~     your tooth. When a tooth is infected with bacteria, we can see a dark area on the radiograph~     around the roots of the infected tooth. If this dark area becomes smaller or goes away~     completely after root canal treatment and you do not feel any pain or other symptoms, then we~     know that the treatment was successful and there is no need for further treatment on this~     tooth. To measure the size of the dark area around the tooth (i.e. volume) before and after~     the treatment we will need to take two limited volume three-dimensional radiographs (cone~     beam computed tomography-CBCT), one prior to treatment and one at two years after the root~     canal treatment is completed. These radiographs are more accurate in detecting changes in~     lesion size than the regular periapical radiographs. We will assess the changes in lesion~     volume for all teeth included in the study and that will help us find differences in success~     between the two root canal treatment protocols, We are specifically looking for persons that~     have been diagnosed with a necrotic permanent mandibular molar with an evident radiographic~     lesion (i.e. dark area around the tooth) that can be retained in the mouth with root canal~     treatment and permanent restoration. This study place participants in different treatment~     groups after randomization. Randomization means that you are placed by chance (like flipping~     a coin) into a treatment group. For this study, there are two treatment groups (protocol) and~     they are listed below.~      Protocol 1: Group S: Root canal treatment will be performed in 2-visits using hand files and~     rotary instruments to a final canal shape of size #25.~      Protocol 2: Group L: Root canal treatment will be performed in 2-visits using hand files and~     rotary instruments to a final canal shape of size #35~   "
39242|NCT03053024|"~     The purpose of the study (retrospective and prospective) is to describe participant and~     disease characteristics and treatment pattern of Bortezomib treated mantle cell lymphoma~     (MCL) participants in China.~   "
39243|NCT03053011|"~     As part of developing a relay alarm project, the aim of the study is to test a sleeper's~     capability to wake up via a vibrating alarm around the wrist (vibrating bracelet).~   "
39244|NCT03052998|"~     Many studies have reported an association between epilepsy, including Nodding Syndrome (NS),~     and onchocerciasis (river blindness). A high prevalence of epilepsy has been noted~     particularly in onchocerciasis hyperendemic areas where onchocerciasis is not or~     insufficiently controlled with mass Ivermectin distribution. There is evidence that~     increasing the coverage of Ivermectin reduces the incidence of epilepsy and anecdotal~     evidence suggests a reduction in seizure frequency in onchocerciasis associated epilepsy~     (OAE) patients who receive Ivermectin. Finding an alternative treatment for epilepsy in these~     patients will have major consequences.~      Objective~      To assess whether Ivermectin treatment decreases the frequency of seizures and leads to~     seizure freedom in OAE patients, including patients with NS. If we are able to demonstrate~     such an effect this would be an extra argument that Onchocerciasis is causing epilepsy and~     that therefore we should increase our efforts to eliminate onchocerciasis.~      Methods~      We will conduct a randomized clinical trial in the Democratic Republic of Congo (DRC) to~     compare seizure freedom in onchocerciasis infested epilepsy patients who receive immediate~     Ivermectin treatment with delayed (after four months) Ivermectin treatment. All participants~     will simultaneously receive anti-epileptic drugs (AEDs) according to local guidelines for~     epilepsy treatment. The primary endpoint is seizure freedom defined as no seizures during the~     fourth month of follow-up. Secondary endpoint is significant (>50%) seizure reduction~     compared to baseline seizure frequency. Reduction of seizures will be compared between~     Ivermectin and non-Ivermectin arms.~      Current status~      Start of enrolment is planned from March 2017 and we expect to have enrolled all 110~     participants by August 2017. Results are expected early 2018.~      Discussion~      If Ivermectin treatment, in addition to AEDs, is able to lead to seizure freedom or~     significantly reduces seizure frequency in OAE patients this will have major consequences for~     epilepsy treatment in Onchocerciasis endemic regions. Ivermectin is donated for free, and in~     non Loa-Loa endemic regions has negligible side effects. Reducing the burden of epilepsy will~     have a major impact on quality of life and socio-economic status of families with affected~     members in Africa.~   "
39245|NCT03052985|"~     Observatory of Materiovigilance After Surgery of Urinary Incontinence or Prolapse in Women~     Implantable medical devices (meshes) used in pelvic organ prolapse surgery (genital prolapse,~     rectal prolapse), or incontinence surgery may be source of severe complications.~   "
39246|NCT03052972|"~     This study is designed to assess the imaging characteristics of Flortaucipir (18F-AV-1451) in~     subjects who participated in the Biomarkers of Cognitive Decline Among Normal Individuals~     (BIOCARD) study at Johns Hopkins University.~   "
39279|NCT03052543|"~     This pilot study is being conducted to determine whether the intraoperative presence of a~     Bispectral Index Monitor (BIS), a non-invasive monitor, affects the perioperative and~     postoperative indices and outcomes. The BIS monitor is an adhesive sensor that is applied to~     the forehead to monitor EEG waves. This monitor is not a Standard of Care Monitor, yet in~     adult and pediatric studies it has been shown to decrease time to emergence, decrease~     volatile anesthesia requirement, decrease recovery time and in some cases, decrease~     post-operative morbidity (REFS). The effect on intra-operative and post-operative parameters,~     when BIS is present but not specifically designated to be used as a monitor to guide~     anesthesia delivery, has not been specifically examined. This will be the first pediatric~     study which applies BIS on all patients and randomizes the anesthesiologists to either be or~     not be privy to seeing the BIS values during intra-operative period.~   "
39247|NCT03052959|"~     The BETTER intervention consists of supportive meetings between a specially trained~     prevention practitioner nurse and individuals aged 40-64 years to review recommended chronic~     disease prevention and screening activities (CDPS). The prevention practitioner nurse will~     assist participants to identify goals for accomplishing CDPS activities in the next 6 months.~     Promotion, recruitment of participants and delivery of the BETTER intervention will be~     adapted to meet the needs of the residents through the use of participatory research methods~     and community engagement strategies. The study population consists of individuals aged 40-64~     years living in 10 designated areas or clusters within Durham Region in Oshawa and Whitby.~      Objectives:~        1. Help people in the designated areas identify personal goals related to chronic disease~          prevention and screening activities.~        2. Evaluate whether the prevention practitioner was effective in helping people achieve~          their goals and explore whether this type of intervention could work in other settings.~        3. Share what the investigators learn with government and other public health units in~          Ontario and across Canada.~      Some clusters will receive the BETTER intervention right away and other clusters will be in a~     wait-list control group to receive the intervention 6 months later. Our main outcome is the~     change in a score that considers the number of preventive health items a person has achieved~     during the 6 months. The investigators will also be doing in-depth interviews and focus~     groups with health care providers, community organizations and people who live in the~     designated areas to understand whether the primary practitioner was effective.~   "
39248|NCT03052946|"~     Randomized trial with a estimated number of 60 patients with mild or moderate anal~     incontinence at the clinic Physiology of the Hospital das Clínicas of the Medical School of~     the University of São Paulo (HC-FMUSP).~        -  Exclusion criteria: symptoms of anal incontinence for less than six months, with severe~          anal incontinence, associated external anal sphincter damage, past pelvic radiotherapy,~          evidence of perineal sepsis, rectal prolapse, anorectal cancer, inflammatory bowel~          disease, malignant disease Congenital formation, scleroderma, Parkinson's disease,~          immunosuppression and ongoing gestation. In addition, those patients who do not agree to~          participate in the survey will be excluded.~        -  The study will have 4 phases: preoperative, surgical, recent postoperative and later~          postoperative~   "
39249|NCT03052933|"~     COPGEM (Copanlisib and Gemcitabine)chemotherapy regimen is proposed as the salvage treatment~     for relapsed or refractory peripheral T-cell or NK/T-cell lymphomas in this study protocol,~     which would be expected to be feasible and effective in this group of patients.~      Copanlisib (BAY 80-6946), a highly selective and potent class-1 PI3K inhibitor with~     sub-nanomolar IC50s against PI3Kα and PI3Kδ, has demonstrated activity in~     relapsed/refractory, aggressive NHLs, suggesting an ORR of 50% for T-cell lymphomas.~      Gemcitabine has demonstrated clinical antitumor activity against PTCLs including NK/T-cell~     lymphomas both as single-agent (ORR 30-50%) and in combination therapy, with limited~     extramedullary toxicities.~      Considering the evidence of activity for both agents against PTCLs, the investigators propose~     that targeted therapy with copanlisib in combination with gemcitabine will exhibit early~     elimination of rapidly growing tumor cells and be a rational therapeutic modality for use in~     relapsed or refractory PTCLs, if the overlapping toxicities can be managed.~   "
39250|NCT03052920|"~     This longitudinal study evaluates the possible benefit of cochlear implantation in the poor~     ear of adults with asymmetric hearing loss who continue to use a hearing aid in the better~     hearing ear.~   "
39251|NCT03052907|"~     The investigators will expand BSPan's reach and sustainability by systematizing how to enable~     counties to assume responsibility for one or two of the components while Moncrief/uTSW~     continues to provide centralized financial review and reimbursement as the Texas BCCS~     contractor. The investigators will prospectively identify which counties have the necessary~     program capacity, then test whether implementation of BSPan tailored to a county's capacity~     and local needs can lead to equivalent program success in an additional 12 rural counties.~     Findings will be used to develop a model by which BSPan benefits can be brought to rural~     communities across the country.~      The investigators will use a readiness assessment criteria (RaC) to gauge county capacity and~     readiness for BSPan program implementation. The goal of our evaluation is to demonstrate~     whether a regional decentralized delivery (hub-and-spoke) model can be sustained and increase~     program reach to underserved rural women. The RaC tool serves two purposes: 1) to determine~     county capacity and 2) harness program data to facilitate communication during operations~     between a central BSPan hub and each county partner (spokes).~      Our evaluation will analyze county training and implementation of BSPan program components,~     and comprehensive screening processes of the hub and spoke model. The investigators will use~     county site visits and selected interviews of participants and staff to gain insight into~     factors at the participant and county levels that facilitate adoption and implementation of~     comprehensive screening processes, in conjunction with key quantitative metrics and process~     outcomes.~      The investigators will apply the Glasgow Re-aiM model to guide our evaluation of BSPan~     program component implementation in each county. Re-aiM specifies dimensions at the~     participant and organizational levels. Dimensions are defined as the intervention's: 1) Reach~     into the target population, 2) effectiveness in modifying risk, 3) adoption by target~     settings, 4) consistent implementation, and 5) Maintenance of its effects among participants~     and target settings. our mixed-methods approach will enable focus at both the individual and~     organizational levels and has been successfully used to assess other similar screening and~     health promotion programs.~   "
39252|NCT03052894|"~     The objective of this study is to determine the accuracy of a hydraulically coupled twitch~     monitor compared to the EMG twitch monitor in current use to measure the extent of~     neuromuscular blockade in patients undergoing general anesthesia.~   "
39253|NCT03052881|"~     The purpose of the study is to determine whether use of a robotic system improves the~     precision and therefore safety of high precision steps in retinal surgery. Two common~     surgical scenarios (ERM/ILM peel and sub retinal haemorrhage displacement surgery) that~     require a high degree of precision to avoid damage to the retina have been chosen for this~     trial. These steps also have been selected because they allow a clearly definable outcome~     measure e.g. time taken to complete a specific step in the operation. The main issue here is~     that the patients will be undergoing this procedure regardless of enrolment in the trial -~     the only difference being that for study participants the surgeon will perform parts of the~     operation with the assistance of the robot.~   "
39254|NCT03052868|"~     Data for this study will be obtained from the University of Texas Southwestern Medical Center~     Simmons Comprehensive Cancer Center. Participants will be recruited through Simmons Cancer~     Center. One hundred female breast cancer patients who have completed adjuvant chemotherapy~     will be enrolled. In order to reach this number, it is estimated that up to 125 eligible~     participants will need to be recruited. The study will last approximately two years.~     Participants will undergo one cognitive testing session, and each subject's total~     participation time will last no more than two hours.~   "
41081|NCT03029013|"~     The study is the single arm and single center clinical trials，We conduct the phase II~     clinical trial to further explore the efficacy and safety of Apatinib and chemotherapy~     sequential treatment with advanced recurrence of metastatic cervical cancer~   "
39255|NCT03052855|"~     Suicidal behaviors (SB) are a major health problem in France : 10 000 suicides and 220 000~     suicide attempts every year. SB management is therefore a major public health issue.~      Evidence associated dysregulation of the serotonergic system and the~     hypothalamic-pituitary-adrenal axis to vulnerability to SB. Recent data point to linke these~     abnormalities with neuroinflammatory clues, glutamatergic function and neuronal plasticity.~     There is a need to better understand the physiopathology and develop diagnostic and~     therapeutic tools in SB.~      The investigators hypothesize that increased peripheral biomarkers of inflammation would~     correlate to a disturbance of the cerebral metabolites, such as glutamate and NAA, especially~     in suicidal patients.~      Our aim is to compare rates of cerebral metabolites, in particular the complex~     glutamine/glutamate, in cerebral areas involved in suicidal vulnerability (the anterior~     cingulate cortex and the orbito-frontal cortex) between person with unipolar disorder with~     and without suicidal attempt.~   "
39256|NCT03052842|"~     Single-blind study to evaluate whether C16G2 Strip administered in multiple doses can~     effectively kill the bacteria in the oral cavity that cause dental caries..~   "
39257|NCT03052829|"~     The benefits of regular physical activity are well-established. Furthermore, the~     investigators have previously shown that in a population of patients with implanted~     pacemakers, those who exercise more than 2 hours daily have improved survival compared with~     those who exercise less than 2 hours daily. In this study, the aim f the investigators is to~     determine whether the offering subjects with pacemakers who have low levels of physical~     activity at baseline counseling to increase physical activity levels is effective as measured~     by their implanted device as well as by an external pacemaker.~      The investigators seek to enroll about 30 patients into a 6-month 1:1 randomized~     interventional trial comparing the levels of physical activity in 2 groups, those who receive~     physical activity counseling versus usual care. The activity levels will be measured with~     external pedometers and with accelerometers embedded within the pacemaker device.~   "
39258|NCT03052816|"~     The purpose of this randomized controlled trial is to determine whether, ICE-T, a novel~     multimodal postoperative pain regimen composed of around the clock ice packs, toradol, and~     tylenol, has improved pain control intake compared to the standard postoperative pain regimen~     in patients undergoing vaginal pelvic floor reconstructive surgery.~   "
39259|NCT03052803|"~     The aim of the study is to compare different devices available to measure fractional flow~     reserve (FFR) in coronary arteries.~   "
39260|NCT03052790|"~     The purpose of this study is to compare the outcomes and accuracy of implant positioning in~     robotic assisted total knee arthroplasty with traditional manually instrumented total knee~     arthroplasty.~   "
39261|NCT03052777|"~     This study evaluates the impact of a 12-week theory-based exercise telephone counselling~     program (versus a self-directed exercise group) on closing the exercise intention-behavior~     gap in a sample of hematologic cancer survivors.~   "
39262|NCT03052764|"~     This study will evaluate the efficacy and safety of onabotulinumtoxinA 100 U (BOTOX®),~     compared to placebo, when injected into the bladder using an alternative injection paradigm~     in reducing the number of daily urinary incontinence episodes in patients with overactive~     bladder (OAB) and urinary incontinence whose symptoms have not been adequately managed with~     an anticholinergic.~   "
39263|NCT03052751|"~     The purpose of the study is to evaluate the clinical efficacy of UCB7665 as a~     chronic-intermittent treatment in subjects with generalized myasthenia gravis (MG) who are~     classified as moderate to severe.~   "
39264|NCT03052738|"~     This study proposes to do a prospective observational cohort study evaluating the quality of~     life (QOL) of children with Central Nervous System (CNS) tumors and their families who choose~     to self-medicate with marijuana-derived products while undergoing treatment at Children's~     Hospital Colorado (CHCO).~   "
39265|NCT03052725|"~     This is a multicenter, open-label (OL) extension study to obtain additional long-term safety~     data for subcutaneous (sc) administration of reslizumab treatment administered at a fixed~     dose of 110 mg in patients 12 years of age and older with severe eosinophilic asthma who~     completed the treatment period of a placebo-controlled Phase 3 trial of sc reslizumab. The~     study consists of a screening/baseline visit followed by a 36-week OL treatment period and a~     15-week follow-up period.~   "
39266|NCT03052712|"~     The role of disorders of socio-emotional processes in cerebral diseases such as Alzheimer's~     disease, frontal temporal dementia, Parkinson's disease, Huntington's disease, traumatic~     brain injury, stroke, focal lesions, has been recognized recently. Social cognition refers to~     a large group of emotional and cognitive abilities regulating inter-individuals relationships~     and it includes mainly theory of mind, emotional information processing and empathy. However,~     assessment of socio-emotional processes is still largely based on experimental tests that are~     not validated for clinical purpose. In addition their long duration of administration is not~     adapted to clinical examination. Finally these tests have not been standardized and~     normalized in French-speaking population.~   "
39267|NCT03052699|"~     This database has for objective to include the medical data of patients which underwent a~     vaginal Cesarean Section in our establishment. This collection will allow to determine the~     risk factors of the maternal morbi-mortality and to estimate the long-term results~   "
39268|NCT03052686|"~     This study has for objective to collect medical data from patients with uterine rupture at~     the childbirth.~   "
39280|NCT03052530|"~     A prospective, open label, multi-center, single arm, observational study designed to evaluate~     the acute safety and device procedural success of the Sapphire II PRO 1.0 and 1.25 mm PTCA~     dilatation catheters in subjects with stenotic coronary arteries or bypass grafts during~     percutaneous coronary intervention.~      Sixty (60) subjects will be treated at up to 5 U.S. sites with the Sapphire II PRO diameters~     1.0 and 1.25 mm PTCA dilatation catheters to pre-dilate coronary arteries or bypass grafts~     during their index procedure. All subjects will be screened according to the protocol~     inclusion and exclusion criteria and will be followed through hospital discharge.~   "
39281|NCT03052517|"~     This study is a 2-treatment period, randomized, multicenter parallel-group study. The overall~     purpose of this study is to provide long- term safety data for fevipiprant (QAW039) (Dose 1~     and Dose 2), compared with placebo, when added to the Global Initiative for Asthma (GINA)~     steps 3, 4, and 5 standard-of-care (SoC) asthma therapy (GINA 2016), in patients with~     moderate-to- severe asthma.~   "
39269|NCT03052673|"~     The surgical interventions for treating morbid obesity, i.e. bypass procedure and sleeve~     gastrectomy are collectively covered under the term `bariatric surgery`. The growth of~     bariatric surgery has seen consonant development of anaesthesia techniques so as to ensure~     patient safety and facilitate post-surgery outcome. Conventionally, balanced general~     anaesthesia techniques routinely use opioids peri-operatively for intra-operative~     haemodynamic homeostasis and postoperative pain relief. However, since the morbidly obese~     patients have high prevalence of obstructive sleep apnea(OSA) and other co-morbidities the~     same technique when employed in the morbidly obese patients hampers early and intermediate~     postoperative recovery due to the occurrence of side effects, such as, sedation, PONV,~     respiratory depression, depressed GI-mobility. The above stated side effects, have lead to~     increased propensity for postoperative cardiac and pulmonary complications. Obese patients~     are more vulnerable and sensitive to the narcotics and sedatives, these drugs need to be~     employed judiciously in these patients. On the other hand, the reduction in opioid use may~     result in acute post-operative pain that may limit post-surgery rehabilitation. Therefore, we~     need to minimise opioid use and employ some other drugs which besides having analgesia, has a~     opioid-sparing effect also.~      Ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, has analgesic properties in~     sub-anaesthetic doses. When used in low dose (0.2mg/kg), it is an analgesic,~     anti-hyperalgesic, and prevents development of opioid tolerance. On a conceptual basis, a key~     advantage of ketamine is that it can reduces post-operative pain and use of opioid when used~     per-operatively. Therefore, a regimen which avoid or minimise use of opioid is likely to~     decrease opioid-related postoperative morbidity in these patients undergoing bariatric~     surgery.In view of the above, a clinical research is highly desirable to study techniques to~     decrease the use of opioids in obese surgical patients.This prospective randomised two-arm~     study aims to assess the effect of low-dose ketamine on postoperative pain relief and~     opioid-sparing ability in obese patients undergoing bariatric surgery.~   "
39270|NCT03052660|"~     We aim to assess, if placebo compared to preoperative administration of midazolam in elderly~     patients is equal in regard to the global postoperative patient satisfaction~   "
39271|NCT03052647|"~     The objective of this study was to compare the an adhesive latch device ( Dermaclip) to~     subcuticular skin closure at the time of cesarean section. Currently, no studies exist~     comparing these two closure techniques. The hypothesis is dermaclip closure is faster than~     subcuticular closure. The null hypothesis is there is no difference in closure times. There~     is a study (see reference at bottom) that compares staples closure to subcuticular closure,~     but none comparing subcuticular to dermaclip closure. Dermaclip device is easily deployed and~     is expected to be as fast as staples closure compared to subcuticular as noted in the prior~     study referenced below.~   "
39272|NCT03052634|"~     A significance,safety and pharmacokinetic of open-label and multicentric Phase Ib/II Study of~     RC48-ADC Administered Intravenously to Subjects With HER2-Positive in Advanced Breast Cancer~   "
39273|NCT03052621|"~     Locally advance breast cancer and extensive locoregional recurrence are still considered as~     complexity of reconstruction. Although previous studies concluded that omental transposition~     was considerably indicated in poor vascularity in irradiated tissue, secondary infection and~     large defect become the obstacles of local tissue flaps. While some centres showed the~     excellent healing of omental transposition. Meanwhile, many studies showed the preferable~     outcome in escalating radiotherapy in term of locoregional control. In the investigators'~     institute, omental transposition in breast cancer has been developed for twenty years. The~     only institute in Thailand enhanced using this procedure in order to closure of large primary~     breast cancer and chest wall recurrence. This procedure is undertaken by single surgeon (Dr.~     K.J.). The investigators' protocol of omental transposition is including preoperative~     chemotherapy, preoperative accelerated radiation up to 80 Gy, approval of breast cancer~     centre committee, and meticulous wound care including vacuum assisted wound dressing,~     non-adhesive dressing. As a result, survival time could be improved.~   "
39274|NCT03052608|"~     A phase 3 study to demonstrate whether lorlatinib given as monotherapy is superior to~     crizotinib alone in prolonging the progression-free survival in advanced ALK-positive NSCLC~     patients who are treatment naïve and to compare lorlatinib to crizotinib with respect to~     overall survival in the same population~   "
39275|NCT03052595|"~     Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central~     nervous system (CNS) and is one of the most common neurological diseases, often leading to~     disability of the patients. The MS pathogenesis includes vascular and inflammatory~     components, however recently also the role of mitochondrial dysfunction being a hot topic in~     neurodegeneration.~   "
39276|NCT03052582|"~     The aim of the project is to investigate the effects in humans of a daily intake of whole~     milk compared to skimmed milk primarily and secondarily respectively on:~        -  Blood lipids: total-, LDL-, and HDL-cholesterol and triglycerides~        -  Risk markers of diabetes type 2: plasma glucose and insulin~   "
39277|NCT03052569|"~     Expanded access to RXDX-105 will be given to patients with cancers harboring RET alterations~     who have not received TKIs that target RET alterations, who do not qualify for participation~     in, or who are otherwise unable to access, an ongoing clinical trial for RXDX-105.~   "
39278|NCT03052556|"~     Background The main risk factor for cervical cancer is the infection by human papillomavirus~     (HPV), with several intermediate steps between HPV infection and cervical cancer. Cervical~     screening with pap smear test and HPV vaccination are effective preventions. A high frequency~     of HPV carriage and of cervical dysplasia have been described in transplanted women.~      The majority of women with cystic fibrosis reach adulthood and some will face~     transplantation. Particular attention should therefore be paid to cervical screening.~     However, low adherence to screening recommendations was noted. In addition, preliminary data~     has found a high frequency of abnormal smears and of inflammatory aspect of the cervix in~     women with cystic fibrosis.~      Objectives of the study The main objective of the study is to determine the prevalence of HPV~     carriage in a cohort of women with cystic fibrosis~      The secondary objectives are:~        -  To study the factors associated with the prevalence of HPV (transplantation, smoking,~          age at first intercourse, number of sexual partners in the year, contraception,~          gravidity and parity, HPV vaccination)~        -  To describe and to compare with data in the general population, in hospital-based~          population, (and with data in transplanted population for transplanted women)~             1. the prevalence of HPV (and of different genotypes) infection, of cervical~               dysplasia, of vulvar/vaginal/cervical condylomatosis~             2. the rate of HPV persistence (> 12 months), the mean time of HPV clearance; rates of~               spontaneous regression / persistence / worsening of cervical dysplasia~      Study design:~      The study will last 24 months. Includable patients are adult women, transplanted or not,~     followed at Lyon CRCM. Included women will attend a consultation with a gynaecologist. Pap~     smear test (liquid phase cytology) and genomic DNA microarray assay enabling the detection of~     35 different HPV genotypes will be performed.~      Patients with an initial abnormal pap smear or a positive HPV test will be monitored:~        -  In case of an abnormal smear and / or positive HPV test, pap smear and HPV testing will~          be renewed every 6 months during the study period~        -  In case of an abnormal smear:~      Atypical squamous cells of undetermined significance (ASC-US) : the attitude will depend on~     the result of the HPV test Atypical squamous cells - cannot exclude HSI L (ASC-H), Low-grade~     squamous intraepithelial lesion (LSIL), High-grade squamous intraepithelial lesion (HSIL),~     Atypical glandular cell of undetermined significance (AGUS) , Atypical glandular cells (AGC)~     , Adenoma carcinoma in situ (AIS), carcinoma: a colposcopy will be systematically performed~      Expected results This study will help to determine the frequency of HPV infection and the~     pathogenic power of HPV in non-transplanted and in transplanted women with cystic fibrosis~     This data will help to sensitize health professionals on the importance of gynecological care~     and regular cervical screening, and on the importance of HPV vaccination.~      In case of a high frequency of genital diseases linked to HPV, recommendations on~     gynecological monitoring procedures for women with cystic fibrosis could evolve.~   "
39290|NCT03052400|"~     Randomized, double blind, placebo-controlled clinical trial examining the efficacy and safety~     of mifepristone 600 mg daily in male subjects with type 2 diabetes mellitus, not associated~     with Cushing's syndrome~   "
39291|NCT03052387|"~     Using autogenous Chin block for vertical augmentation with simultaneous implant placement at~     anterior maxilla region comparing between the Onlay and Inlay grafting techniques.~   "
39282|NCT03052504|"~     The study will examine which differences there are in comorbidity and complications collected~     retrospectively from medical records compared with data collected prospectively in two groups~     of patients undergoing either radical cystectomy or radical nephrectomy.~      Hypothesis is that he prevalence of registered comorbidity and minor complications in~     patients who have undergone radical cystectomy or nephrectomy, will increase if the data~     collection is focused and prospective, compared with retrospectively collected data.~      The study will be conducted as a single-blind randomized controlled trial. Patients included~     in the study will be randomized to either control or intervention in the ratio 1:1. There are~     two groups of patients: Patients admitted to radical cystectomy and patients admitted to~     radical nephrectomy, due to cancer.~   "
39283|NCT03052491|"~     This open-label field trial evaluates the effects of treatment with a multi-pathway dietary~     supplement (Stem Cell 100+) that has been commercially available for several years. The~     objective of the intervention trial is to determine if normal subjects over 35 years of age~     experience any observable health benefits from the dietary supplement as to their blood~     pressure, pulse rate, blood cholesterol, lung capacity, stress levels, or self reported~     changes in markers of overall health and life expectancy.~   "
39284|NCT03052478|"~     There is no accepted standard therapy for patients with advanced gastric cancer who have~     progressed during or after second-line therapy. The role of 3rd line treatment in advanced~     gastric cancer has not been proven.~      As a novel target of gastric cancer, SMO overexpression is chosen in this study, and the~     investigators plan this study to evaluate the efficacy and safety of vismodegib in gastric~     cancer. The doses of vismodegib are based on trials of basal cell carcinoma.~   "
39285|NCT03052465|"~     Crohn's disease (CD) is becoming more common. One of the main features of this disease is~     weight loss and malnutrition with symptoms such as tummy aches and bloating. These problems~     have a strong negative effect on the patients' quality of life but the causes of these~     problems are not well understood. Enteroendocrine cells are nutrient sensors in the bowel~     that secrete special chemicals (called hormones) that control appetite and the movements all~     the gut. The investigators think that this control mechanism goes wrong in Crohn's patients~     and they have set off to do more research on this. Looking at the inside work of the gut has~     always been difficult and at times unpleasant for patients, however recent developments in~     magnetic resonance imaging (MRI) are allowing the investigators to study the workings of the~     gut in greater detail and without discomfort for the patients.~      Our main objective is to investigate the difference in small bowel motility between CD~     patients with active ileal disease and healthy volunteers.~   "
39286|NCT03052452|"~     The proposed My Nutritional Health (MNH) app is a unique tool for consumers interested in~     tracking their food intake and linking diet to symptoms.~      The investigators will test this app for developmental purposes among a sample of 100~     participants who are patients of dieticians at Cedars-Sinai Medical Center (CSMC) and the~     University of Michigan (UM) with varying presentation of GI symptoms and suspected food~     intolerances. The MNH app will be used as a data collection platform for this study and can~     be utilized by any device supporting iOS (tablets, ipads, iphones, and Android. The~     investigators will use the data collected in the app testing to develop population level FAST~     scores.~      The MNH app includes two integrated functions:~        1. Patient Symptom and Food Consumption Reporting~        2. FAST Score calculation It is important to note that, per this protocol, the MNH app will~          only be evaluated for developmental purposes. It is currently not meant to serve as a~          diagnostic tool, nor to provide referrals for patients with food and symptom patterns~          that may suggest a food intolerance. In this respect, our test app is not governed by~          FDA or other regulatory bodies, as it does not make diagnoses or offer specific~          guidance. The purpose of this study is only to develop normative scoring distributions~          of FAST within the context of patients visiting GI dieticians as part of routine care.~   "
39287|NCT03052439|"~     Irritable bowel syndrome (IBS) is the most common gastrointestinal disease, affecting 12% of~     the US population and up to 20% of the population worldwide. This is a condition that is~     diagnosed based on specific symptoms of altered bowel habits and abdominal pain, as well as~     the exclusion of select other GI diseases. IBS not only causes constipation, diarrhea,~     abdominal cramping, and bloating, it also significantly affects quality of life, overall~     functioning, and work productivity.~      The cause of IBS is likely multifactorial, which makes it a difficult disease to treat.~     However, patients often associate their IBS symptoms with eating a meal. Up to 90% of IBS~     patients restrict their diet to prevent or improve their symptoms, and patients are~     increasingly interested in more holistic approaches to disease management. At present, the~     most persuasive evidence that dietary changes can treat IBS supports a diet low in~     fermentable carbohydrates (the low FODMAP (fermentable oligo, di, and monosaccharides and~     polyols) diet). This diet, which is low in certain carbohydrates, has been shown to improve~     IBS symptoms (particularly abdominal pain and bloating), but can be difficult to follow and~     quite restrictive. In addition, this diet is not meant to be used as a maintenance diet;~     patients undergo an elimination phase followed by a reintroduction phase of specific~     carbohydrate groups as they monitor their symptoms. From the results of our proposed study,~     the study team hopes to arrive at a modified, less -restrictive version of the low FODMAP~     diet that is equally effective, and also create a standard protocol that patients can use~     during this reintroduction phase.~      Patients with IBS will be recruited into a 13-week trial that would help determine the~     optimal way in which high FODMAP foods should be introduced. After consent, patients would~     start on a low FODMAP diet for 14 days, and if their symptoms improve, they would be invited~     to continue in the study. For 7 days prior to the reintroduction of individual FODMAPs,~     patients will ingest 1daily servings of a low FODMAP nutrition drink to validate the low~     FODMAP content of this dietary supplement. If patients do not experience a flare of symptoms~     with the supplement, they enter the reintroduction period. During this period, subjects would~     introduce different groups of FODMAPs in a blinded fashion while remaining on an otherwise~     low FODMAP diet while monitoring their IBS symptoms. At the end of the study period, subjects~     would be informed of the FODMAPs to which they were sensitive and would meet with a~     dietitian. At the completion of the study, the investigators would compile the data and~     determine which FODMAPs were mostly likely to exacerbate IBS symptoms, thus providing the~     construct for a modified low FODMAP diet, or low FODMAP-Light. It is hoped that this~     modified, less restrictive version of the low FODMAP diet would be equally effective for the~     majority of IBS patients.~   "
39288|NCT03052426|"~     The aim of this study is to combat the growing global health issue of sedentary behavior and~     the associated health consequences of prolonged sitting in the workplace. The population of~     desk-based workers makes up a relatively large population and are an important target for~     this health promoting initiative with a focus on improving posture, encouraging movement, and~     fostering a more active and healthy business community. It's important to recognize that~     occupational therapy practitioners can contribute to community health promotion/disease~     prevention programs by the skill-set of practitioners to understand habits and routines that~     influence the adoption and maintenance of healthy behaviors.~   "
39289|NCT03052413|"~     The objective of this study is to assess the safety and effectiveness of a nutraceutical~     supplement for the treatment of hair loss and thinning in females over the course of six~     months of continuous daily use.~   "
39292|NCT03052374|"~     Postpartum depression (PPD) is a major public health issue. Known as the thief that steals~     motherhood since symptoms obstruct a mother's capacity for understanding and enjoying her~     baby, PPD affects approximately 1 in 5 moms. Built via serve and return interactions (e.g.~     baby smiles, mom smiles back), sensitive and responsive exchanges are the foundation for~     healthy child development but are diminished by PPD, resulting in interactions that place~     children at risk for behavioural and cognitive problems. Infants perceive PPD as stressful;~     stressors stimulate the brain's hypothalamic pituitary adrenal axis (HPA) and trigger stress~     hormone (cortisol) release, which, in turn, negatively affects developing infant brains by~     decreasing brain volume. Infants' critical periods of brain development are vulnerable to~     long-term effects of cortisol, explaining some of the problematic developmental outcomes~     observed in children of depressed mothers.~      How can the investigators support depressed mothers and their infants? Successfully treating~     PPD does not always benefit mother-child relationships; however, this research builds on a~     successful pilot that demonstrated that nurse-guided video feedback improved mother-infant~     interactions in the context of PPD. By improving interaction quality, depressed mothers may~     be motivated to engage in more play and, in turn, infants who appear interested and ready to~     interact are more likely to elicit positive, enjoyable experiences from mothers. Building on~     the pilot, the investigators will trial the effectiveness of VID-KIDS (Video-Feedback~     Interaction Guidance for Improving Interactions Between Depressed Mothers and their Infants)~     on maternal-infant interaction and infant cortisol patterns as well as infant development,~     maternal symptoms of depression and anxiety, and parenting self-efficacy. If successful,~     future aims are to 1) integrate VID-KIDS into existing services of Calgary Public Health; and~     2) commercialize VID-KIDS for dissemination.~   "
39293|NCT03052361|"~     The investigators aim to assess whether ondansetron given at triage can reduce the number of~     patients requiring emergency department observation in children with acute gastroenteritis.~     The investigators will also assess the improvement of patient comfort and total length of~     stay~   "
39294|NCT03052348|"~     Atopic dermatitis (AD) is a chronic, relapsing inflammatory skin disease that occurs most~     commonly during early infancy and childhood. It is frequently associated with abnormalities~     in skin barrier function, allergen sensitization and recurrent skin infections. AD is a major~     public health problem worldwide, with prevalence in children of 10-20% and 2-5% of the~     general population. The skin of AD patients is susceptible to colonization and infection with~     Staphylococcus aureus (SA )which contribute significantly to the severity of the clinical~     manifestations of eczema, triggering a vicious cycle.~      Fusidic Acid (FA) cream is a topical antibiotic widely used in the treatment of skin and soft~     tissue infections and infected atopic dermatitis. However in recent years, the emergence of~     drug-resistant organisms, e.g. Methicillin- resistant Staphylococcus aureus (MRSA) has led to~     scrutiny of antibiotic use. Prolonged use of topical FA has been linked with emergence of~     FA-resistant Staphylococcus aureus (FRSA) . Fusidic acid is a natural antibiotic, extracted~     from cultures of Fusidium coccineum, which has a powerful antibacterial action. Topical use~     of Fusidic acid is fully in line with therapeutic strategies that recommend the use of an~     antibiotic with the narrowest activity spectrum to minimize the risk of resistance. In AD~     with infected lesions, combined treatment with antibiotic and steroid demonstrates greater~     efficacy over the use of steroid.~      Trial Design: A three-center, double blind, randomized ,phase II , parallel group, efficacy~     trial.~      Type of Intervention: A triple compounded cream containing a topical antibiotic , topical~     steroid and moisturizer.~      Type of control: Active control containing a double compounded cream comprising a topical~     steroid and moisturizer .~      Study population and Setting: A sample of 78 subjects will be recruited from Red Cross~     Children's Hospital , Nelson Mandela Academic Hospital and King Edward Hospital Estimated~     duration of trial: 12 months. Duration of participation: Each subject will participate in the~     trial for a maximum of 140 days.~      Primary endpoint: reduction in SCORAD scores; frequency of clinical flares for AD and~     improvement in the quality of life at 140 days.~      The benefit of this trial is that it provides a simple and effective approach to the~     management of atopic eczema.~   "
39295|NCT03052335|"~     Main objective is to improve colorectal cancer (CRC) screening programme in the Czech~     Republic and decrease the disease incidence and mortality. The secondary aim is to verify the~     effectiveness of incorporation of the new minimally invasive device in the prevention~     programme.~   "
39296|NCT03052322|"~     The purpose of this study is to compare the efficacy, safety and immunogenicity of MSB11022~     and Humira® in adult subjects with rheumatoid arthritis.~   "
39297|NCT03052309|"~     The purpose of the BIOLUX P-III BENELUX Registry is to further investigate the safety and~     clinical performance of the Passeo-18 Lux Drug Coated Ballon when used in daily clinical~     practice for the treatment of isolated atherosclerotic lesion (vessel narrowing) in popliteal~     arteries~   "
39298|NCT03052296|"~     The purpose of the BIOLUX P-III Spain registry is to further investigate the safety and~     clinical performance of the Passeo-18 Lux Drug Coated Balloon in the treatment of long~     atherosclerotic femoropoliteal artery lesions in daily clinical practice~   "
39299|NCT03052283|"~     Development, validation and evaluation of a new multimodal questionnaire to assess and~     quantify the abdominal involvement in patients with the inherited life shortening multi-organ~     disease Cystic fibrosis.~   "
39300|NCT03052270|"~     1. This will be a randomized prospective and open-label study with no placebo control or~          blinding of the participants and the research team members. The study is to compare the~          effectiveness of vaginal progesterone versus combination of vaginal progesterone and~          Arabin cervical pessary in the prevention of preterm delivery among patients with~          incidental shortened cervical length.~        2. As part of standard clinical care, all pregnant patients usually have cervical length~          measurements at the mid-trimester during the anatomy scan from 18 to 24 weeks with the~          GE ultrasound Volusion 8 using the vaginal probe.~             1. Patients with short cervix will be counseled and offered the opportunity to~               participate in the study.~             2. All participants will be taught how to use the vaginal progesterone once daily~               prior to bedtime. In addition, those in the combination group will have the~               cervical pessary placed in the clinic right away or within a week if they request~               for more time to brood over their diagnosis and weigh on the option of inserting~               Arabin pessary.~             3. All participants will be followed up in the high-risk obstetric clinic as per~               standard prenatal care. Frequency of follow up visits will be individualized~               depending on patient's need and comorbidities. , Participants will be requested to~               bring the remnant of the vaginal progesterone to the clinic to assess compliance.~             4. Participants in the study will continue their prenatal care with UIC high-risk~               obstetric clinic until delivery.~             5. The study recruitment will occur for a period of 2 years starting from November~               2016 to October 2018 or until all the anticipated numbers of study subjects have~               been attained.~             6. There will be 10 % over-sampling to cater for those who will drop out from the~               study or loss to follow up after randomization, and those who delivered in another~               hospital.~             7. Participants will have access to one of the investigators or the high- risk clinic~               nurse for any complaints related to their conditions.~             8. Participants can opt out at any stage of the study if they do not want to continue~               further or if there are any adverse effects.~   "
39301|NCT03052257|"~     The proposed study is a randomized controlled trial enrolling Veterans with medically treated~     glaucoma who report less than 100% adherence to the prescribed glaucoma therapy. Participants~     will be randomized to receive either a one-on-one session with a member of the research team~     discussing the disease process and strategies for administering eye drops (intervention) or a~     one-on-one session with a member of the research team discussing general eye health~     (control). All participants will be provided with a smart bottle to house their glaucoma~     medications. The smart bottle records the date and time that the bottle is opened. For~     participants in the intervention arm only, a reminder function will be activated. The~     proportion or prescribed doses taken according to the monitor will be compared for the two~     groups.~   "
39302|NCT03052244|"~     Transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) will be~     applied for patient who suffer from neuropathic pain following spinal cord injury The tDCS~     treatment will be coupled with a video of a man walking (creating a visual illusion) in order~     to enhance functional ability and reduce pain~   "
39303|NCT03052231|"~     Real-world adherence to inhaled and oral therapies for cystic fibrosis (CF) patients remains~     discouragingly low, ranging between 31-53% for inhaled antibiotics and 41-72% for hypertonic~     saline. Programs to enhance adherence, including comprehensive behavioral interventions with~     adolescents, have met with mixed success. Advances in therapy, treatment delivery systems,~     and data capture technology offer the potential for enhancing adherence by providing~     immediate and more frequent feedback to the patient regarding his or her fidelity to the~     prescribed treatment regimen. The investigators propose to evaluate a systematic yet~     technically simple approach to linking treatment and feedback components to enhance adherence~     in a real-work CF clinic setting that treats a significant minority patient population.~      This is the first trial assessing the impact of a collaborative active intervention program~     of a multi disciplinary team in improving adherence to specific chronic medications and~     improving clinical outcomes in CF patients. The PI has implemented the texting service~     (Caremessage.org) with COPD and diabetes patients. The content will be modified to provide~     both English and Spanish language content relevant to these participants and their standard~     treatment protocols.~   "
39304|NCT03052218|"~     Pupillometry will be performed before administration of tramadol, at T0 and then 1 to twice~     per hour in children having received tramadol as a pain killer as part of his/her routine~     care.~      Pupillometry measurement will be correlate to CYP2D6 phenotype and CYP2D6 genetic score~   "
39305|NCT03052205|"~     This is a Phase 1b study that incorporates dose expansion cohorts to further evaluate~     promising clinical or biological activity.~   "
39306|NCT03052192|"~     In this study, the investigators will investigate and characterize acute medical patients in~     order to optimize patient courses in the acute care departments, especially with regard to~     polypharmacy and undernourishment. In addition, the investigators will investigate underlying~     immunological mechanisms of chronic inflammation and biological aging in this population to~     improve the current knowledge and possibilities for preventing chronic diseases and acute~     hospitalization.~   "
39307|NCT03052179|"~     Oral Lichen Planus (OLP) is an inflammatory disease of mucosal and skin with unknown~     etiology. The prevalence rate in England is reported to be between 1-2.4%. OLP contributed to~     around 40% of all visits or 1,200 appointments in 2014 at the Eastman Dental Hospital. Pain,~     discomfort, long-standing use of medications, lesion recurrence and adverse side effects of~     therapy are commonly associated with OLP, eventually leading to a significant reduction in a~     patient quality of life. In addition, there is also increased risk of developing oral cancer~     in patients with OLP. The current gold standard treatment for OLP is corticosteroid, which~     can result in adverse side effects including increased risk of infections and skin cancer,~     reduced systemic immune system, and hepatotoxicity with long-term usage.~      Alternatively, a probiotic food supplement, VSL#3, has shown evidence of been able to induce~     and maintain remission in Intestinal Bowel Disease (IBD), with no adverse effect a part than~     bloating, reported. Additionally, a preliminary report shown that probiotics treatment in~     Behcet's disease and Recurrent Aphthous Stomatitis (RAS) lesion resulted in reducing the~     number of oral ulcerations and subjective relief of oral discomfort.~      Investigator designed a clinical trial with 30 participants allocated to one of two~     interventions, VSL#3 or placebo. Individuals with biopsy-confirmed OLP who experience painful~     symptoms will be recruited from a single site research site (Eastman Dental Hospital (EDH)).~     Either the active VSL#3 or the placebo, provided by Ferring Pharmaceuticals Limited, will be~     consume twice a day over a 30 days period. Questionnaires that will determine pain levels,~     disease activity and quality of life will be completed before the study begins, on days 15,~     30 and 30 days after the last supplement intake. In addition saliva and blood samples will be~     taken before therapy begin, at 30 days of therapy, and 30 days after the last supplement~     intake. The levels of pro-inflammatory cytokines and the oral microbiota will be investigated~     using these samples. A blinded clinician will assess the clinical effects between groups of~     active VSL #3 and placebo and the results will analyze by statistician.~   "
39308|NCT03052166|"~     Brief Summary: The QT Ultrasound system is an automated scanner which transmits pulsed~     ultrasound plane waves through the breast, as well as collects reflected ultrasound output.~     As the patient lays prone on a table, the breast is submerged in a warm water bath. The~     transmitter and receiver assembly moves around the suspended breast to record data for~     successive sub-volumes of targeted tissue. More than 2000 elements in the curvilinear~     transducer's array encircle the breast to gather data from the tissue structures of the~     breast, from nipple to chest wall. Information gathered from this automated QT scan~     encompasses the entire breast which is currently not commercially available using any other~     ultrasound technology.~   "
39309|NCT03052153|"~     This study will evaluate if an association exists between levels of blood flow through the~     pulmonary veins and the incidence of graft dysfunction post operatively.~   "
39310|NCT03052140|"~     Single-blind, randomised, single centre, 2-way crossover study to collect post-market~     clinical follow-up data on the CE-marked Lamelleye dry eye drops medical device.~   "
39311|NCT03052127|"~     The primary objective is to assess the safety, immunogenicity and preliminary efficacy of one~     of three dose levels and repeat dose regimens of Light-activated AU-011 and one or two laser~     applications for the treatment of subjects with primary choroidal melanoma.~   "
39312|NCT03052114|"~     The purpose of this study is to determine if Electrical Impedance Tomography (EIT) can~     produce reproducible and accurate images in people with stroke or head injury compared to~     existing standards such as MRI, CT.~      Electrical Impedance Tomography is a relatively new medical imaging method, which has the~     potential to provide novel images of brain function. It is fast, portable, safe and~     inexpensive, but currently has a relatively poor spatial resolution. It produces images of~     the internal electrical impedance of a subject with stroke or head injury using rings of ECG~     like electrodes on the skin. EIT recording will take place as early as possible, usually~     within 24 hours of admission. Following completion of the recording, the EIT images will~     subsequently be analysed and compared to other imaging data for accuracy.~   "
39313|NCT03052101|"~     The aim of this study is to conduct survey-based assessments for the safety of air travel in~     patients with pulmonary Langerhans cell histiocytosis (PLCH). The study will enroll patients~     through the clinic network at Rare Lung Disease Consortium (RLDC) and through the~     Histiocytosis Association website. Patients will have access to the questionnaire via REDCap~     (an online data management system) and each patient will be provided with a link to complete~     the survey. The investigators plan on enrolling approximately 200 patients with PLCH for the~     purpose of this study. Secondary aims of this study include further characterization of the~     clinical aspects of disease and to establish a contact registry for these patients, in order~     to facilitate future studies.~   "
41832|NCT03019172|"~     RCT to evaluate the safety and efficacy of Lactobacillus reuteri DSM 16666 & Lactobacillus~     reuteri DSM 17938 to significantly modify the frequency of clinical or bacteriological cure~     in women with non complicated acute cystitis who receive probiotics for 12 days compared with~     the frequency in women who receive placebo.~   "
39314|NCT03052088|"~     This is a prospective clinical validation study of a novel regulatory approved (CE-IVD)~     diagnostic assay called ImmunoXpert™ that will enroll 1222 pediatric patients. The study aims~     to externally validate the tool's diagnostic accuracy and estimate the potential improvement~     in health and economic outcomes following the usage of ImmunoXpert™. Additionally,~     statistical analysis will be performed to compare ImmunoXpert™ accuracy to current practice~     lab testing (e.g. WBC, CRP, and PCT) and clinical suspicion at time of requisition. Enrolled~     patients will be managed according to the current standard of care and per standard~     institutional procedures.~   "
39315|NCT03052075|"~     The primary objective of this study is to estimate the percent change in baseline bone~     mineral density (BMD) starting at one year after parathyroidectomy and all the following~     available dates in patients presenting with primary hyperparathyroidism. The secondary~     objective is to identify patient factors associated with change in BMD.~   "
39316|NCT03052062|"~     The objectives of this clinical study are to determine the tolerance of dietary supplement~     Lipidrive through the evaluation of several parameters :~        -  Various blood biological parameters~        -  Urinary parameters~        -  Hemodynamic indicators~        -  Cardiac function~        -  Anthropometric variables~   "
39317|NCT03052049|"~     This is an open-labeled, non-randomized feasibility study to evaluate the safety of prostate~     artery embolization (PAE) for the treatment of lower urinary tract symptoms attributed to~     benign prostatic hyperplasia (BPH).~   "
39318|NCT03052036|"~     SENIOR-RITA is a multicentre prospective open-label trial randomizing patients presenting~     with type 1 NSTEMI aged ≥75 years between invasive and conservative treatment strategies, to~     compare time to cardiovascular death or non-fatal MI within one year from randomization.~   "
39319|NCT03052023|"~     This study designed to compare the new laparoscopic dual approach to inguinal hernia repair~     with trans-abdominal preperitoneal (TAPP) and lichtenstein repair (open procedure)~   "
39320|NCT03052010|"~     An implementation project to scale-up delivery of antiretroviral-based HIV-1 prevention~     methods to Kenyan HIV-1 serodiscordant couples in HIV-1 care centers. Pre-exposure~     prophylaxis (PrEP) as a bridge to antiretroviral therapy (ART) HIV-1 prevention strategy will~     be introduced into 24 public HIV-1 care centers in central and western Kenya according to~     national guidelines using a stepped wedge design, stratified by region.~   "
39321|NCT03051997|"~     The purpose of this study is to test a prize-based contingency management intervention for~     increasing caregiver engagement in juvenile drug court and adolescent drug treatment, and for~     achieving the ultimate outcomes of reduced substance use and delinquent behavior among drug~     court-involved youth.~   "
39322|NCT03051984|"~     Total knee replacement, or arthroplasty, is the final clinical intervention available to~     relieve pain and functional limitations related to advanced stage knee osteoarthritis.~     Despite its beneficial effects, the early post-surgical period is characterized by the~     erosion of lower extremity muscle size and strength that cause further disability and slow~     functional recovery. While the detrimental effects of this period on muscle are widely~     recognized, the mechanisms underlying these adaptations are poorly understood and there are~     currently no widely-accepted clinical interventions to counter them~   "
39323|NCT03051971|"~     Delivery of inhaled short-acting bronchodilators (SABD) is standard of care in the emergency~     department (ED) for exacerbation of COPD, the goal of such being rapid reversal of airflow~     obstruction. However, current guidelines for the delivery of SABDs in spontaneously breathing~     patients make no distinction whether these medications should be delivered via metered dose~     inhaler (MDI) or jet nebulizer (JN), the specific medication delivery device having no~     significant effect on hospital admission or reversal of flow obstruction. However,~     advancements in nebulizer design, namely FDA-approved vibrating mesh technology, have~     demonstrated significant improvements relative to JNs and metered dose inhalers in efficiency~     and amount of drug delivered in in vivo and in vitro studies. Currently there are no clinical~     trials comparing the use of vibrating mesh nebulizers (VMN) to JNs and their effect on~     clinically important outcomes. This prospective randomized controlled pilot trial seeks to~     determine if there are differences in hospital admission due to COPD when a vibrating mesh~     nebulizer is used versus a jet nebulizer.~   "
39324|NCT03051958|"~     Atopic dermatitis (AD) is highly prevalent and leads to suffering for the individual,~     increased risk of depressive symptoms and anxiety, and high societal costs. A few~     psychological treatment have been tested for AD, but to our knowledge none of them have been~     built on recently developed methods for optimizing exposure treatment. In addition, access to~     psychological treatment is limited and there is a need for new methods that could be easily~     disseminated. One possible solution to this problem is to deliver psychological treatment via~     the Internet, which has been tested in more than 100 randomized trials with good results for~     other clinical disorders than AD. The aim of this study was to test the effects of~     Internet-delivered mindfulness and exposure treatment (I-MET) for AD in a randomized~     controlled trial. We hypothesized that I-MET would lead to larger reductions of AD symptoms~     as well as psychological symptoms compared to treatment as usual.~   "
39325|NCT03051945|"~     Demonstrate the acute effects of ketamine on endogenous µ-opioid neurotransmission in humans.~   "
39326|NCT03051932|"~     This is a single-center, randomized, double-blind, placebo-controlled trial. A total of 100~     patients, 50 per treatment arm, undergoing minimally invasive thoracic surgery will be~     randomized 1:1 across 2 treatment arms: Ofiramev® (acetaminophen) injection 1,000 mg (100 mL)~     plus patient-controlled analgesia (PCA) and 100 mL placebo plus PCA.~   "
39327|NCT03051919|"~     Laparoscopic sleeve gastrectomy is a technically simple popular bariatric operation with~     acceptable results. Leaks can occur in long staple lines; therefore, variable reinforcement~     methods are used.~   "
39337|NCT03051789|"~     A 4-armed cluster randomised controlled trial conducted among secondary schoolgirls in Siaya,~     western Kenya, where clusters are the unit of allocation and schoolgirls the unit of~     measurement. The overall aim of the trial is to inform evidence-based policy to develop~     intervention programmes which improve adolescent girls' health, school equity and~     life-chances. The primary objective is to determine the impact of menstrual cups or cash~     transfer alone, or in combination, compared against controls, on a composite of deleterious~     outcomes (HIV, HSV-2 infection, and school dropout) over 3 schoolyears follow-up.~   "
39328|NCT03051906|"~     In over 60% of cases, squamous cell carcinoma of the head and neck (SCCHN) is discovered at a~     loco-regionally advanced stage that requires a combined multimodal strategy in order to~     pursue a curative intent. Bonner et al demonstrated that the combination of radiation (RT)~     with Cetuximab (CTX), a chimeric mouse IgG1 monoclonal anti-EGFR antibody, results in better~     median locoregional control and overall survival compared with RT alone without an increased~     rate of > G3 acute toxicity or detrimental effect on compliance and quality of life. However,~     subsequent negative trials (RTOG 0522) led to the hypothesis that in unselected patient~     populations the benefit of CTX may be diluted due to the molecular heterogeneity of SSCHN.~     Moreover, the absence of biomarkers predictive of response to anti-EGFR treatment may in part~     be explained by the observation that other factors play a role in favoring its anticancer~     effect, namely immunologic mechanisms. It has been demonstrated that SCCHN is an~     immunosuppressive disease characterized by prominent immuno-escape mechanisms, such as~     induction of a tumor-permissive cytokine profile and qualitative/quantitative lymphocyte~     deficiencies, occurrence of anergy in major immune effector cells and poor antigen~     presentation. Given these observations, it has been postulated that SCCHN may benefit from~     immunotherapeutic strategies, primarily aimed at PD-L1/PD1 checkpoint blockade. Segal et al~     (Asco 2015) reported preliminary results on the use of Durvalumab in pretreated patients with~     recurrent/metastatic SCCHN. Durvalumab is a humanized monoclonal IgG1 antibody that blocks~     PD-L1 binding to PD-1 and CD80 with high affinity and selectivity, thereby promoting activity~     of tumor-specific effector T cells and global anti-tumor immune response. Out of 64 treated~     patients, 51 patients were available for the preliminary efficacy analysis: promisingly, the~     overall response rate was 12% (25% in PD-L1 positive patients). To date, no clinical trial,~     specifically designed for SCCHN, testing PD-L1 targeted agents has been completed, nor have~     been initiated combination strategies of CTX, RT and PD1/PD-L1 antibodies in the curative~     setting. Taken all data together, a strong rationale may support the combination of~     Durvalumab, anti-EGFR therapy such as CTX and RT in order to revert the SCCHN-induced immune~     suppression and maximize treatment efficacy, ultimately through enhanced, CTX-mediated immune~     mechanisms and maximized RT-specific cytotoxicity.~   "
39329|NCT03051893|"~     This was an open label, randomised, single dose study, comprising Part A (undertaken in two~     separate three-period crossover cohorts denoted as A1 and A2) and Part B (undertaken in one~     four-period crossover cohort), to evaluate the PK of Chronocort® in healthy male volunteers.~     The washout interval in both Part A and Part B was 1-week in between each treatment period.~   "
39330|NCT03051880|"~     The purpose of this study is to evaluate the preventive efficacy of topical EGF cream for~     dermatologic adverse events related to EGFR inhibitors.~   "
39331|NCT03051867|"~     The purpose of the present study is to understand the effect of pregnancy on vitamin D~     metabolism and requirements as well as the modulatory role of the placenta in vitamin D~     metabolism during pregnancy. In addition, a human placental cell culture model will be~     employed to examine vitamin D metabolic flux in human trophoblast cells. The impact of~     maternal vitamin D status on maternal and fetal bone health during gestation will also be~     examined.~   "
39332|NCT03051854|"~     Beside the home, the school is often the second important setting for the development and~     education of children and adolescents. Students spend a large part of their life at school.~     However, there is recurrent occurrence of violence against children and of harsh discipline~     measures used in home and school settings. These may result into negative consequences.~     Hence, prevention strategies against the use of harsh discipline use in schools become a~     priority.~      In the baseline of this study the investigators will therefore examine the prevalence and~     consequences of violence against children in Southwestern Uganda. The study will be conducted~     in schools and common disciplinary measures used by teachers, and the perceptions of~     teachers' and students' in relation to commonly used and experienced disciplinary measures we~     will be investigated.~      In the second phase, the investigators then will implement and assess the effectiveness of an~     intervention aimed at reducing the use of harsh and violent disciplinary measures in schools.~     ICC-T training in the long-term aims at fostering better relations amongst students and~     teachers. Based on feasibility studies, ICC-T intervention is expected to result into better~     teacher-student relationships, change in teachers' attitudes and behaviors concerning the use~     of violent disciplinary measures in the school setting.~   "
39333|NCT03051841|"~     This study is to determine the maximum tolerated dose(MTD), dose limiting toxicity(DLT),~     safety and pharmacokinetics(PK) profile of a single agent CKD-581 injection in Combination~     with Bortezomib and Dexamethasone in patients with Previously Treated Multiple Myeloma.~   "
39334|NCT03051828|"~     The data collection of physical evaluations after regular practice of the fencing at patients~     having surgically been treated for breast cancer highlighted encouraging results both on the~     functional drawing, and on the improvement of the quality of life.~   "
39335|NCT03051815|"~     Apart from obesity, craniofacial factors are well recognized in the pathogenesis of~     obstructive sleep apnea (OSA) and are likely to play an important role in influencing the~     response to weight loss. The prevalence of OSA syndrome is as common among the middle-aged~     Hong Kong Chinese populations as the Caucasians, despite our Chinese patients having much~     lower body mass index (BMI). From previous work on ethnic comparison, for the same degree of~     OSA severity, Caucasians were more overweight, whereas Chinese exhibited more craniofacial~     bony restriction. Cephalometric measurements based on lateral radiograph of the upper airway~     have shown that a shorter distance between maxillary projection from the cranial base, a~     smaller posterior airway space, less mandibular protrusion, a narrower space between the hard~     palate and cranial base, and a more caudally placed hyoid bone predispose to a higher~     apnea-hypopnea index (AHI). A recent study shown that a shorter mandibular length as measured~     by lateral cephalometry was associated with a greater fall in AHI after weight loss. Another~     study using craniofacial computed tomography (CT) scans to evaluate the maxillomandibular~     bony volume found that craniofacial restriction influenced the relationship between weight~     loss and OSA improvement. Collectively, these studies suggest that the effect on AHI with~     weight loss is likely to be more pronounced in those with a smaller craniofacial skeleton.~     However, the effect of the craniofacial restriction on the degree of rebound in OSA following~     weight gain after the weight loss intervention is unknown.~      The study aims to investigate the change in weight and OSA severity following cessation of a~     lifestyle modification program (LMP) and examine the relationship between craniofacial~     restriction and the degree of OSA reoccurrence.~   "
39336|NCT03051802|"~     The scope of this clinical trial is to assess the clinical feasibility of this procedure,~     optimize the protocol and perform an initial comparison of the positional accuracy of~     navigated endoscopy and applicator insertion versus the standard of care 2D fluoroscopy~     protocol.~   "
39396|NCT03051022|"~     The study aimed to compare the effectivity of dexamethasone 8 mg and morphine 2 mg as an~     adjuvant to epidural bupivacaine 0,125% 12,5mg for post-operative analgesia in lower~     extremities.~   "
39397|NCT03051009|"~     Demonstrate the safety and tolerability of desmopressin ODT during long-term treatment of~     subjects with nocturia due to nocturnal polyuria, for up to 1 year~   "
39338|NCT03051776|"~     Breast cancer-related lymphedema (BCRL) tends to become chronic and progressive. Current~     therapies have modest results for this condition. Compression garments (CG) prevent the~     worsening of lymphedema and even improve it, during periods between treatments of physical~     therapy. Kinesio Taping(KT) is being recently used for lymphedema, although little evidence~     backs it. The aim of this study is to compare the reduction of lymphedema volume with both~     therapies.~   "
39339|NCT03051763|"~     The aim of this study is to 1) descriptively report possible in flight events and 2) to~     provide regression analysis if the number of events are statistically significant in their~     prevalence and thus are useful in finding possible parameters in echocardiography, right~     heart catheterization, laboratory findings, spiroergometry as well as six minute walk test to~     produce a risk assessment for possible expected in flight adverse events as well as a~     recommendation concerning the need of supplemental oxygen for each individual patient.~      The investigators therefore want to find out:~        1. In which subgroup (if applicable) of PH patients in flight adverse events are more~          frequent.~        2. Whether there are parameters (from blood samples, blood gas analysis, World Health~          Organization-Functional Class (WHO-FC), Six Minute Walk (SMW), echocardiography, right~          heart catheter (RHC)) that are able to predict in flight need for additional oxygen~          and/or possible adverse events.~   "
39340|NCT03051750|"~     This crossover study compares two different treatment techniques for Breast Cancer-Related~     Lymphedema: 1. Complex Physical Therapy plus Pressotherapy.~      2. Kinesio Taping.~   "
39341|NCT03051737|"~     The main objective of this retrospective study is to validate a prediction system of~     emergencies department (ED) attendance on a wide range of time and the need for~     hospitalization, at various levels of perimeter (with all emergency departments or one ED in~     particular), with all patients or with one sub-group of patients (age, gravity, care).~   "
39342|NCT03051724|"~     Obstructive sleep apnea is a very frequent syndrome and Continuous Positive Airway Pressure~     (CPAP) is the gold standard treatment. Nevertheless, obtaining the sufficient compliance is~     complex. New communication technologies and the current health challenges, such as aging and~     high health care costs have encouraged the interest in new strategies.~      As showed recently, telemedicine is an alternative (Isetta, Thorax 2015) in patients that use~     internet and mobile technologies usually. However, there is a significant percentage of~     patients that does not use Internet and mobile technologies, only the 58% of patients over 65~     years uses them (Dorsey, NEJM 2016). Although evidence regarding telemedicine is conflicting,~     it suggest that it's applicability depends in patient's characteristics and it is necessary~     to personalize it to make it safe and effective (Takahashi, Arch Intern Med 2012). That's why~     the investigators believe that the next step should be to choose those patient's that doesn't~     use Internet or mobile technologies and to verify the applicability of a telematic system~     that could facilitate the extra hospital management of this patient's.~      The aim of the study is to evaluate the telematic management of various outcomes that are~     emitted by CPAP machine, and by an app where the patient's will answer different questions~     regarding their treatment during the three months of study period.~   "
39343|NCT03051711|"~     To evaluate the effect of GBT440 on oxygen saturation at rest and exercise, under hypoxic~     conditions, at Day 15 compared to Baseline.~   "
39344|NCT03051698|"~     The purpose of this proof-of-concept study is to determine the effect of Intestinal~     Microbiota Depletion or Intravenous Administration of C1-inhibitor on Inflammation and~     Coagulation after Bronchial Instillation of House Dust Mite Allergen and Lipopolysaccharide~     in Allergic Asthma Patients~   "
39345|NCT03051685|"~     Crossover study to compare the BA of DFN-15 at 3 different doses versus the comparator to~     determine dose-proportionality of DFN-15 in healthy volunteers under fasting conditions~   "
39346|NCT03051672|"~     This research study is studying radiation therapy in combination with an immunotherapy as a~     possible treatment for metastatic hormone receptor (HR) positive, HER2-negative breast~     cancer.~      The interventions involved in this study are:~        -  Palliative Radiotherapy~        -  Pembrolizumab~   "
39347|NCT03051659|"~     This research study is exploring chemotherapy in combination with immunotherapy (a therapy~     that uses the body's own immune system to control cancer) as a possible treatment for~     metastatic hormone receptor positive breast cancer.~   "
39348|NCT03051646|"~     Exercise has many benefits for people with multiple sclerosis (MS), such as improved physical~     symptoms, mood, fatigue, and cognition. However, many people with MS refrain from exercising~     because of the discomfort of exhaustion and overheating that they experience. This study~     investigates the use of aspirin before exercise as a treatment to reduce overheating and~     exhaustion, thereby availing many more people with MS the opportunity to benefit from~     exercise.~      The investigators recently published the first-ever report of elevated body temperature in~     relapsing-remitting MS (RRMS) patients relative to healthy controls, and elevated temperature~     was linked to worse fatigue. This finding that body temperature is elevated and linked to~     fatigue in RRMS lays the groundwork for a paradigm shift in our understanding and treatment~     of fatigue. That is, the focus shifts from exogenous to endogenous temperature, and from~     stimulant medication to cooling treatments.~      A recent study comparing healthy adults to adults with MS showed that whereas exercise~     increased body temperature in both groups, only in the MS group was it correlated with~     exhaustion. The reason for this may relate to the elevation in resting body temperature in~     relapsing-remitting MS (RRMS) patients relative to healthy controls. The finding is~     clinically meaningful, as elevated body temperature was correlated with worse fatigue in~     patients. Exercise Aim: To determine whether pretreatment with ASA (compared to placebo:~     within subject crossover design) before exercise results in improved exercise performance~     (i.e., increased time-to-exhaustion). The investigators hypothesize that participants will~     tolerate exercise for longer after taking ASA than placebo. This hypothesis is based on a)~     demonstrated efficacy of antipyretic for reducing body temperature during exercise in healthy~     controls, b) demonstrated efficacy of antipyretic for reducing fatigue in non-exercising MS~     patients, and c) demonstrated efficacy of elaborate (unblinded) cooling treatments (e.g.,~     cooling garments, cooling hand chamber) for improving exercise performance in MS patients.~     Note that this project is especially important for MS patients, who have a disease-specific~     body temperature elevation and sensitivity to heat (i.e., Uhthoff's).~   "
39349|NCT03051633|"~     The goal of this project is to test the effectiveness of a successful anti-drug~     communications campaign (Be Under your Own Influence) to lower substance use among AI 7th~     graders. The campaign uses messages that support youths' personal autonomy and future~     aspirations, and these messages are delivered to 7th graders using high school students. Our~     goal is to develop a turnkey package for the broader population of AI youth and schools and~     to develop components that can incorporate flexibility and creativity in their delivery.~   "
39350|NCT03051620|"~     The study is a cohort study comprising 140 patients with osteoporosis stopping treatment with~     alendronate. The study will contribute with new knowledge about biochemical markers of bone~     turnover as predictors of bone loss after stopping treatment with alendronate.~   "
39351|NCT03051607|"~     Phase 3, international, multicenter, open-label 12 month safety study.~   "
39352|NCT03051594|"~     1. Three dentinal carious lesions will be chosen in this study and will be in the same~          patient.~        2. Using local anaesthesia and rubber dam, the operative field will disinfected with 1%~          hypochlorite, and the dentine lesions should be exposed with a high-speed diamond bur by~          removing covering enamel.~        3. Before the excavation dentine samples are collected for baseline bacteriological~          assessment .~        4. Excavation will be carried out using new slow speed round burs and hand excavators.~        5. The excavation end point of one cavity will be determined using visual tactile method.~          The two other cavities will be inspected with fluorescent camera or caries detector dye~          (CDD) methods to determine excavation endpoint respectively.~        6. After excavation, dentine samples from the three cavities will be collected using a~          sterile excavator for the bacteriological assessment.~             -  Number of visits & follow up period: all procedures will be done at the same visit~               and there is no follow up period.~      Direct benefit of the research to the human volunteer: to determine the excavation endpoint~     to ensure complete caries removal and prevent it's recurrence in the future.~      Scientific value and social benefits: to reach the best method to determine the excavation~     endpoint.~      Expected risk to the human subjects: the ordinary side effects associated with any~     restorative treatment and no of the study variable has side effect on the patient and in case~     of any side effect due to the restorative treatment, the participant will directly contact~     the operator.~   "
39353|NCT03051581|"~     The purpose of this study is to evaluate whether 18F-FDG PET/CT-based prognostic model of~     PTCL can predict disease progression~   "
39354|NCT03051568|"~     The purpose of this study is to evaluate whether a semi-quantitative interpretation using the~     liver SUVmax as reference can better interpret 18F-FDG PET/CT and predict disease progression~     during chemotherapy or survival in PTCL.~   "
39355|NCT03051555|"~     The purpose of this study is to evaluate whether 18F-FDG PET/CT-based prognostic model of~     NK/T-cell lymphoma can predict disease progression~   "
39356|NCT03051542|"~     The purpose of this study is to evaluate whether a semi-quantitative interpretation using the~     liver SUVmax as reference can better interpret 18F- FDG PET/CT and predict disease~     progression during chemotherapy or survival in NK/T-cell lymphoma.~   "
39357|NCT03051529|"~     This study was conducted on 24 patients who have ischemic dilated cardiomyopathy, underwent~     non cardiac surgery in the lower half of the body under the effect of combined spinal~     epidural anesthesia at Assiut university hospital. Intraoperative Hemodynamic monitoring~     including invasive blood pressure, heart rate, and CVP was established, in addition to pre~     and postoperative, 12 lead ECG, echocardiography, and venous sampling for Brain natriuretic~     peptide measurement were done .~      This study tried to assess the safety of this anesthetic technique on such group of cardiac~     patients along over the hospital stay period and up to 6 months postoperatively, in addition~     to the predictability of Brain natriuretic peptide as a cardiac biomarker regarding to the~     major adverse cardiac events and cardiac mortality for these group of patients .~   "
39358|NCT03051516|"~     This randomized phase IV trial studies how well human papillomavirus (HPV) vaccine therapy~     works in interrupting progression in patients with high-grade vulvar or anal lesions.~     Vaccines made from HPV peptides or antigens may help the body build an effective immune~     response to kill tumor cells and decrease the chance of vulvar or anal lesions to progress or~     come back.~   "
39359|NCT03051503|"~     to determine the safety, efficacy and tolerability of transdermal fentanyl in patients~     undergoing mastectomy, as well as the postoperative consumption of analgesic.~   "
39360|NCT03051490|"~     Liprotamase powder is a non-porcine, soluble and stable mixture of biotechnology-derived~     lipase, protease, and amylase digestive enzymes. The purpose of the present study is to to~     evaluate the non-inferiority of liprotamase compared with porcine-derived, enterically-coated~     pancreatic enzyme replacement therapy (PERT). The primary efficacy endpoint of the study will~     be comparative efficacy measured as the change from baseline in the coefficient of fat~     absorption (CFA) in Cystic Fibrosis patients with exocrine pancreatic insufficiency (EPI).~   "
39361|NCT03051477|"~     This study will seek to determine the safety and toxicity profile as well as the maximum~     tolerated dose of Helixor® M in patients with advanced solid tumors.~   "
39362|NCT03051464|"~     A randomized study of 40 patients. Patients with a clinical T2-3 N0 rectal cancer will be~     randomized to two arms (arm A: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or~     Xeloda chemotherapy) and an external beam boost of 9 Gy compared to arm B: standard~     chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a~     brachytherapy boost of 30 Gy in 3 fractions).~   "
39363|NCT03051451|"~     Clinical trial, multicenter, double-blind, placebo-controlled, comparative of three parallel~     groups, randomized treatment to assess the efficacy and safety using a fixed dose combination~     of metformin hydrochloride with fluoxetine as adjunctive treatment in patient with obesity or~     overweight in order to generate new knowledge and give a greater number of therapeutic~     options to the clinicians, one group will receive metformin 1700 mg and 40 mg of fluoxetine;~     Another group will receive metformin 1000 mg with 40 mg of fluoxetine, and a third group~     called control will receive placebo.~      The above described treatments will be administered according to the Dosage Schedule The~     three groups will receive tablets of physical characteristics equal to the reference drug to~     preserve the blinding.~   "
39364|NCT03051438|"~     Uniportal video-assisted thoracoscopic surgery (VATS) lobectomy has emerged as a promising~     and exciting approach for minimally invasive thoracic surgery. However, nearly all reported~     uniportal VATS lobectomies have been performed via the intercostal route, and chest wall~     trauma has still occurred. Here,the investigators undertook novel uniportal VATS technique~     involving a subxiphoid route for pulmonary lobectomies to evaluate the feasibility and~     advantages.~   "
39365|NCT03051425|"~     To investigate the impact of consuming dairy yogurt on immun function including natural~     killer (NK) cell activity, circulating levels of cytokines, and immunoglobulin (Ig) in~     elderly.~   "
39418|NCT03050736|"~     The purpose of this Phase 2, open-label, single-arm study is to determine the safety and the~     maximal tolerated dose (MTD) of VAL-083 in combination with a standard of care radiation~     regimen when used to treat newly diagnosed GBM in patients with unmethylated promoter of the~     methylguanine-DNA methyltransferase (uMGMT) gene. Pharmacokinetic (PK) properties will be~     explored and tumor responses to treatment will be evaluated.~   "
39366|NCT03051412|"~     Patellofemoral pain (PFP) is a highly prevalent musculoskeletal condition in adult females,~     which is associated with decreased quality of life and physical activity levels. PFP is~     highly persistent, with up to 50% of adolescents reporting persistent pain at both one and~     two year follow-ups. Previous research has demonstrated altered pain sensitivity in in older~     individuals with chronic pain, however, less is known about this in conditions such as PFP,~     which is common in younger populations. Additionally it is unknown if these characteristics~     return to similar values as healthy controls, when symptoms resolve.~      The aim of this study will be to compare pain sensitivity in individuals with PFP, compared~     to those with a previous history of PFP who currently are pain-free, and a control group with~     no history of knee pain.~   "
39367|NCT03051399|"~     Previous in vitro studies suggest that EpiCor is well fermented in the colon and has~     prebiotic potential. The repeated long-term administration of low doses of EpiCor in the~     Simulator of the Human Intestinal Microbial Ecosystem (SHIME) has shown that this product is~     able to induce gradual changes in the colonic environment by: i) being selectively fermented,~     leading to butyrate increase in the colon; ii) stimulating Lactobacilli growth in the lumen~     and adherence to the mucosal surface, and iii) decreasing potential pathogens. In addition,~     the fermentation-derived metabolites produced in the colon were shown to potentially benefit~     the host by decreasing cytokine levels in vitro. As a result, the investigators hypothesize~     that EpiCor may help to improve bowel function and generally contribute to enhanced gut~     health. Therefore, this pilot study is intended to assess the effects of long-term~     administration of EpiCor on a population with mild symptoms of intestinal dysfunction.~      The primary objective of this exploratory pilot study is to assess the effect of long term~     administration of EpiCor on bowel function and gastrointestinal well-being, by means of~     validated questionnaires.~      This study has 4 secondary objectives: 1) The first secondary objective of this study is to~     assess the protective effects of EpiCor on intestinal barrier function, by performing a gut~     sugar permeability test in combination with indomethacin challenge; 2) The second secondary~     objective is to assess the effects of EpiCor on intestinal barrier function, by measuring~     blood Zonulin and endotoxin levels in combination with indomethacin challenge; 3) The third~     secondary objective of this study is to assess the prebiotic properties of EpiCor by~     collecting fecal samples. The microbial community composition, lactate and SCFA profiles and~     proteolytic activity markers in feces will be determined. Proteolytic activity markers will~     also be measured in urine samples; 4) The fourth secondary objective of this study is to~     assess the effects of EpiCor on local and systemic immune system performance by measuring~     secretory IgA levels in feces and cytokines in blood.~   "
39368|NCT03051386|"~     The purpose of this study is to evaluate the safety and immunogenicity of VEE vaccine, Live,~     Attenuated, dried TC-83, NDBR 102, Lot 4, Run 3, and collect data on the incidence of~     occupational VEE virus infection in vaccinated personnel.~   "
39369|NCT03051373|"~     Gemcitabine plus cisplatin have been the most studied and used anticancer agents in patients~     with local advanced and/or metastatic transitional cell carcinoma of urothelial tract even if~     clinical benefits and survival remains limited.~      The purpose of this study is to test in a randomized trial enrolling patients for comparing~     the efficacy and safety of nab-paclitaxel plus S-1 with Gemcitabine plus cisplatin, in order~     to determine the most promising agents as the first line treatment of advanced and/or~     metastatic transitional cell carcinoma of urothelial tract.~   "
39370|NCT03051360|"~     Investigators plan evaluate whether PCSK9 inhibitors, a medication that can lower~     lipoprotein(a) and control dyslipidemia, can inhibit the progression of aortic stenosis,~     through a randomized controlled trial.~   "
39371|NCT03051347|"~     This is designated to validate patient-reported outcomes (PRO) measures in itch-specific~     pediatric skin conditions, such as atopic dermatitis, and examine the ability of a modified~     stigma instrument to assess the severity and type of stigma experienced in atopic dermatitis~     and other potentially stigmatizing conditions.~   "
39372|NCT03051334|"~     This study sought to evaluate changes in ascending aorta size after transcatheter aortic~     valve replacement (TAVR) in patients with bicuspid aortic valve (BiAV) compared with patients~     with tricuspid aortic valve (TAV).~   "
39373|NCT03051321|"~     The inability to independently manage perineal hygiene after toileting is a common issue for~     those in assisted living and nursing home environments. It is associated with skin breakdown~     (dermatitis), increased nursing costs, and loss of patient self-esteem and independence.~     Water-based toileting has been evaluated as a possible adjunct to patient care, but its~     uptake has been limited by ineffective cleansing and drying.~      40 subjects with limitations in independent capacity for perineal hygiene that require~     assistance with toileting will be recruited from a continued care retirement center. Subjects~     will be assessed for incontinence, and skin breakdown or irritation. Subjects will be~     provided a Wellness Toilet System, cleanser, and, if needed, zinc oxide barrier spray to be~     applied in cases of dermatitis.~      Investigators hypothesize that subjects given the device will remain more independent, with~     higher quality of life. Secondary hypotheses are that subjects will experience improved~     relationships with their caregivers, and that active dermatitis will be treated in those~     already with the condition, and prevented in those at risk.~   "
39374|NCT03051308|"~     Compare the functionality of new parathyroid transport solution (NPTS) with University of~     Wisconsin Solution (UW) on parathyroid glands. Also assess its effects on cell viability,~     parathormone (PTH) secretion, calcium-sensing receptor (CaSR) and vitamin D receptor (VDR)~     levels during cold ischemia.~   "
39375|NCT03051295|"~     There is little evidence on how best to present diagnostic and treatment effect information~     to dentists and whether this makes any difference to their understanding of the information~     given and clinical management. The objective of this study is to assess the influence of~     different formats for presenting diagnostic test results and treatment efficacy on dentists'~     understanding and on their reported clinical management. The hypothesis is that presenting~     diagnostic test and treatment effectiveness results using natural frequencies influences the~     threshold for treatment and improves interpretation of tests results compared to conditional~     probabilities and percentage differences. A group of dentists recruited from postgraduate~     courses were randomized to two of four arms, being two arms of a hypothetical realistic~     diagnostic scenario (a) and two arms of a hypothetical realistic treatment scenario (b): a1)~     diagnostic test results presented in conditional probabilities; a2) diagnostic test results~     presented in natural frequencies; b1) treatment efficacy presented in percentages; b2)~     treatment efficacy presented in natural frequencies. The main outcome measures were the~     correct answer as to whether disease was actually present (post-test probability) and the~     correct answer as the number of patients that would benefit from the treatment (efficacy).~     Secondary outcome measures included the decision whether to treat or not treat the~     hypothetical patient.~   "
39419|NCT03050723|"~     In this study, eligible patients with the medical indications (facial lipoatrophy,~     morphological asymmetry of the face, or debilitating scars) will be treated with Princess®~     FILLER, and then will return for follow-up assessments 2, 4 and 24 weeks after the treatment.~     A touch-up treatment may be done 2 weeks after the treatment.~   "
39376|NCT03051282|"~     Angiotensin-converting enzyme inhibitors (ACEIs) are among the most frequently prescribed~     medications worldwide for the treatment of essential hypertension, left ventricular systolic~     dysfunction, acute myocardial infarction, and prevention of the progression of diabetic~     nephropathy. However, the outcome of ACEI treatment varies significantly between individuals~     and selected populations. Suboptimal response, therapeutic failure, and significant side~     effects are commonly documented in patients receiving ACEI therapy. Approximately 80% of the~     ACEIs available for use in the US are synthesized as esterified prodrugs in order to improve~     otherwise poor oral bioavailability of the active molecule. The activation of ACEI prodrugs~     primarily occurs in the liver via metabolic de-esterification of the parent drug. The~     critical activation step is essential in delivering a successful therapeutic outcome since~     the active metabolites are approximately 10-1000 times more potent relative to their~     respective parent compounds. Carboxylesterase 1 (CES1), the most abundant hydrolase in the~     liver, is responsible for the activation of ACEI prodrugs in humans. Marked interindividual~     variability in CES1 expression and activity has been documented, which results in varied~     therapeutic efficacy and tolerability of many drugs serving as substrates of CES1. Genetic~     variation of CES1 is considered to be a major factor contributing to variability in CES1~     function. The study team proposes to conduct a multiple-dose healthy volunteer study to~     evaluate the impact of CES1 genetic variation on the activation, pharmacokinetics, and~     pharmacodynamics of enalapril, a model ACEI prodrug activated by CES1. The completion of this~     study will represent a major step towards the establishment of an evidence base from which a~     more individualized use of ACEI prodrugs can emerge.~   "
39377|NCT03051269|"~     In a phase I protocol to primarily investigate the safety of using calcium combined with~     electroporation on recurrent head and neck cancers. Secondly, to evaluate tumour response on~     PET/MRI (positron emission tomography/magnetic resonance imaging), clinical evaluation,~     biopsies. Thirdly, to evaluate the effect of calcium electroporation compared to~     electrochemotherapy as well as the patients life-of-quality through questionnaires, EORTC QLQ~     C-30 and H&N35 (european organisation for research and treatment of cancer).~   "
39378|NCT03051256|"~     This a Phase 2a, multicenter, randomized, double-blind, placebo controlled 3 arm study to~     assess the safety and tolerability of multiple oral doses of REL-1017 25 mg and 50 mg as~     adjunctive therapy in the treatment of patients diagnosed with major depressive disorder~     (MDD). The patients will be adults with MDD who are diagnosed with a current MDE who have~     experienced an inadequate response to 1 to 3 courses of treatment with an antidepressant~     medication. This population will provide the opportunity to compare the safety and efficacy~     effects of treatment with an approved antidepressant in conjunction with REL-1017 versus the~     effects of an antidepressant alone. This study includes in-patient and out-patient periods.~   "
39379|NCT03051243|"~     Prospective, open labels, randomized study. A total of 60 admitted patient between 18 and 85~     years old with known with history of DM for more than 3 months and an average of two~     consecutive blood glucose levels above 180 mg/dl (after stopping all previous oral~     antidiabetic and insulin on admission) will be enrolled Patient will be randomized to a 1:1~     ratio in two treatment groups regimens- linagliptin (trajenta) once daily combined with basal~     insulin at bed time (glargine Lantus; sanofi) and basal bolus insulin with glargine once~     daily and glulisine (Apidra; sanifi) before meals.~      Patient will be discharged according to discharged protocol. Follow-up visits will take place~     at 3 and 6 months post discharged.~   "
39380|NCT03051230|"~     Introduction: Ovarian hyperstimulation syndrome (OHSS) is an iatrogenic phenomenon, poorly~     understood and difficult to predict, complicating intense ovarian stimulation cycle. The most~     severe symptoms, which associate vascular permeability disorders and hypercoagulability,~     occur in 0.2 to 1% of the cases and often require intensive care.~      Activation of endothelial, platelet, erythrocyte or leukocyte cells trigger the release of~     small specific vesicles, called microparticles, used as markers.~      Classically leading to endothelial dysfunction and hypercoagulability, the endothelial~     activation phenomenon could constitute the main cause of OHSS or help predict its severity,~     as established for various other diseases (cerebral stroke, infarct and lupus…). However, so~     far, this endothelial activation role has never been studied.~      Objectives:~      Evaluate the serum level of microparticles as a predictor of adverse outcomes; correlate it~     to hypercoagulability and changes of endothelial permeability associated with this syndrome.~      Methodology: Prospective Pilote Cohort study, evaluating before and throughout the ovarian~     stimulation cycle (6 samples/patient), the serum modulation of:~        -  Endothelial activation markers (endothelial-derived microparticles, E-selectin)~        -  Procoagulant markers (microparticles from platelet, erythrocyte or leukocyte origin, Von~          Willbrand factor, thrombin-antithrombin complex, prothrombin fragment 1+2)~        -  Endothelial disjunction marker (soluble CD 146) A group of 50 patients will be assessed~          Techniques: Flow cytometry for measurement of microparticles expressing non specific~          (Annexin V) and cell specific surface determinants (CD 31, CD 41, CD 45 or glycophorin~          A). Use of commercial kits for other serum markers.~   "
39381|NCT03051217|"~     The purpose of this study is to demonstrate the efficacy and safety of Certolizumab Pegol~     (CZP) in the treatment of moderate to severe chronic plaque Psoriasis (PSO) in Japanese~     subjects.~   "
39382|NCT03051204|"~     Study Aims:~      To analyze stool specimens to test and validate the CalproLab assay against the predicate~     PhiCal in order to determine performance characteristics.~      And to correlate Calpro levels to the gut microbiome composition.~   "
39383|NCT03051191|"~     Subjects with cardiovascular diseases (CVD) have higher incidence of cancers compared to~     general population. The investigators hypothesized that shared molecular mechanism play a~     pivotal role in the pathogenesis of CVD including heart failure (HF) and cancers. To address~     this hypothesis, the investigators are going to explore the expression pattern of micro RNA~     (miRNA) and cell free DNA (cfDNA) derived from host, gut microbiota and gut microbiota~     composition extensively in patients with or without CVD, non-ischemic HF (NIHF), and cancers.~     The participants will be recruited from the outpatient clinic in Sakakibara Heart Institute~     or Japanese Foundation for Cancer Research. By comparing the expression pattern of miRNA,~     cfDNA, or gut microbiota composition, the investigators are seeking to find the pathogenic~     mechanisms shared by those diseases.~   "
39398|NCT03050996|"~     Urinary continence recovery remains one of the most bothersome side effect of modern radical~     prostate surgery and several technical modifications, especially in Robotic assisted radical~     prostatectomy procedures, have been reported in order to improve early urinary continence~     recovery.~      With the aim to improve the urinary continence recovery after robotic prostatectomy, we~     evaluate the impact of the use of a 6-branch retropubic suburethral autologous sling, created~     and placed during the procedure, in association with intraoperative evaluation of the~     retrograde leak point pressure by means of retrograde perfusion sphincterometry for proper~     sling tensioning.~   "
39384|NCT03051178|"~     The purpose of this study is evaluate the effectiveness and safety of a possible new~     treatment for Essential Tremor (ET) using external wearable sensors, which have the~     capability of recording acceleration and Electromyography (EMG). This therapy is called~     Responsive Deep Brain Stimulation (R-DBS). R-DBS systems will communicate with a computer,~     and apply stimulation when the computer detects patterns associated with tremor. This~     detection will suppress pathological activity and improve or alleviate the tremor.~      Currently, DBS is approved for the treatment of ET; however, stimulation is delivered~     continuously even when tremor or other symptoms are absent. Continuous DBS can lead to~     unwanted side effects such as stuttering and gait\balance problems. On the other hand, R-DBS~     will turn on only if activity associated with ET from the external sensors is detected.~   "
39385|NCT03051165|"~     This study will evaluate the effect of hypoglossal nerve stimulation (HGNS) on different~     measures of cardiovascular function in patients with obstructive sleep apnea (OSA). People~     with OSA who have undergone implantation of the hypoglossal nerve stimulator at the study~     site will be told about the study at their 2-week post-operative appointment. Those who~     decide to participate will have blood drawn and vascular function measurements taken before~     HGNS activation, during treatment, and after a temporary treatment withdrawal period.~     Following the 30-day period of treatment withdrawal, the HGNS therapy will be reactivated.~   "
39386|NCT03051152|"~     Background: Literature often shows limited and discordant data regarding the prognostic value~     of age in gastric-cancer patients. Generally, disease-specific survival does not seem to be~     worse in the elderly when compared with younger patients, and therefore gastrectomy with~     extended lymphadenectomy for non-early tumors is considered the standard surgical therapy~     for all of operable patients, despite any age- or comorbidity-related limitations. Recent~     trials reported a survival benefit for extended nodal dissection compared with the more~     limited method, but some Authors found age (and comorbidities) to be a relevant predictor of~     postoperative complications, conditioning the safety of the surgical procedure itself.~      Methods/Design: The LELEGA Trial (Limited versus Extended Lymphadenectomy in high risk~     Elderly with Gastric Adenocarcinoma) is a randomized, clinical multicenter trial. All~     patients >75 years and with Charlson Comorbidity Score >5 with resectable M0 gastric cancer~     are eligible for inclusion and randomization. The primary endpoint is 5-year Disease-Specific~     Survival (DSS). Secondary endpoints include 5-year Overall Survival (OS) and postoperative~     complications classified according to Clavien-Dindo. Assuming an alpha (two-sided) of 5%, 232~     patients per group are necessary to achieve an 80% power to detect a 13% survival difference~     (from 56% to 69%) between groups.~      Discussion: LELEGA trial is a prospective, multicenter randomized study to define optimal~     extent of lymphadenectomy (extended versus limited) in elderly and high-comorbidity gastric~     cancer patients.~   "
39387|NCT03051139|"~     The primary objective of this study is to evaluate whether a multi-component implementation~     strategy/quality improvement intervention comprised of 1) clinical decision support that~     couples a natural language processing (NLP) acute respiratory distress syndrome (ARDS)~     recognition tool with a clinician alert system, and 2) audit and feedback improves the~     implementation of low tidal volume ventilation (LTVV) for patients with the acute respiratory~     distress syndrome (ARDS). This will be accomplished with a cluster randomized controlled~     trial comparing the implementation strategy to usual care~   "
39388|NCT03051126|"~     To develop a tissue bank library for patients with parathyroid disease who have undergone~     surgery and/or biopsy, and/or who may undergo surgical intervention at M. D. Anderson Cancer~     Center or outside centers, and/or all patients seen through the Parathyroid Center at~     participating sites, whether or not the patients undergo treatment for their disease. The~     tissue bank will contain both normal parathyroid tissue and diseased tissue, and will provide~     a resource for the ongoing study of parathyroid disease and management.~   "
39389|NCT03051113|"~     Neuromas are frequent after trauma and surgery, including amputation and can be identified by~     high-resolution ultrasound. The role of neuromas as the cause of neuropathic pain is~     uncertain. In this observational cohort study, the investigators wish to explore if the~     prevalence of neuromas are higher in patients with pain after peripheral nerve injury and~     amputation, than in patients with the same conditions but without pain.~   "
39390|NCT03051100|"~     The purpose of this study is to determine if triplet therapy with bempedoic acid (ETC-1002)~     180mg, ezetimibe 10mg, and atorvastatin 20mg is effective and safe versus placebo in patients~     with elevated LDL cholesterol.~   "
39391|NCT03051087|"~     to compare and evaluate the efficacy and safety of Ganilever PFS and Orgalutran® in~     infertility women for assisted reproductive technologies~   "
39392|NCT03051074|"~     The studies proposed in this protocol aim to explore the anxiolytic properties of floating as~     it relates to the central and autonomic nervous system.~   "
39393|NCT03051061|"~     The optimal antithrombotic treatment for Coronary Heart disease (CHD) patients combined with~     Atrial Fibrillation (AF) is unresolved at present. Although the European and American~     guidelines have given a hand for us, there is absence of real-world data on the safety and~     efficacy of antithrombotic therapy in Asian populations. Only a few clinical trials are~     available to guide difficult decision on antithrombotic therapy in patients with combined AF~     and CHD，the investigators highlight the need for the rapid development of clinical trials to~     close the large gaps in evidence. This research aims to know the real-world use of~     antithrombotic treatment and clinical prognosis in Coronary Heart Disease patients~     complicated with Atrial Fibrillation.~   "
39394|NCT03051048|"~     Acute myocardial infarction (AMI) pose a pool clinical outcome to men and women whom~     treatment was delayed. However, reperfusion time was limited in previous studies. To evaluate~     the system delay and clinical outcomes among Chinese patients with AMI, consecutive inpatient~     case prospectively collected from 1999 to 2016. Basic data and innovative evidence will~     accelerate evidence-based clinical practice and policy making, and improve AMI patients~     outcomes finally.~   "
39395|NCT03051035|"~     This phase 1 first-in-human (FIH) dose escalation study will determine the maximum tolerated~     dose (MTD) of KO-947 in subjects with locally advanced unresectable or metastatic, relapsed~     and/or refractory, non-hematological malignancies. If an MTD cannot be identified, a~     recommended phase 2 dose (RP2D) will be determined. In addition, two tumor specific extension~     cohorts may be conducted to further characterize the safety and tolerability of KO-947 and~     provide preliminary evidence of anti-tumor activity.~   "
39401|NCT03050957|"~     Oropharyngeal dysphagia (OD) is the most frequent digestive disorder in older people (>70~     years) and has been recently recognized as a geriatric syndrome. The main features of OD are:~     a high prevalence and severe complications either related with the decreased swallowing~     efficacy with 45% prevalence of malnutrition or due to decreased swallowing safety with 50%~     prevalence of aspiration pneumonia that increases hospital stay by 100% and leads to a 50% of~     mortality rate. However, there is no specific pharmacologic treatment for OD in older~     patients yet. Treatments are now evolving from compensation to active treatments aiming to~     restore the swallowing dysfunction and some groups have been looking for new therapeutic~     strategies. The main goal of this study is to evaluate the effect of administering menthol in~     bolus on the swallowing response in elderly and neurogenic patients with OD. In addition,~     this study will also assess the side effects of this pharmacological strategy.~   "
39402|NCT03050944|"~     Infertility affects one of every six couples and one out of ten couples may seek fertility~     treatment such as ovulation induction and assisted reproductive technologies. With respect to~     diet, several dietary factors, i.e. micro-, macro-nutrients and individual food groups, have~     been associated with the risk of subfertility; however, more information is needed on the~     role of dietary factors in reproductive functions. However, evidence concerning the~     association between dietary patterns, such as the Mediterranean diet (MD) pattern, and~     fertility is scarce. The aim of this study is to investigate the relationship between~     preconception dietary patterns, especially the MD pattern, and in vitro fertilization (IVF)~     outcomes, as well as adiponectin and follistatin concentrations in the plasma and follicular~     fluid of women undergoing IVF treatment. Blood and follicular fluid adiponectin and~     follistatin concentrations will be measured on each day of the ovarian stimulation protocol.~     Main IVF treatment outcomes are fertilization rate, oocyte and embryo quality, implantation,~     clinical pregnancy and live birth rates.~   "
39403|NCT03050931|"~     The purpose of this study is to determine if Electrical Impedance Tomography (EIT) can~     produce reproducible and accurate images in people with epilepsy compared to existing~     standards such as MRI, CT or EEG.~      Electrical Impedance Tomography is a relatively new medical imaging method, which has the~     potential to provide novel images of brain function. It is fast, portable, safe and~     inexpensive, but currently has a relatively poor spatial resolution. It produces images of~     the internal electrical impedance of a subject with epilepsy using rings of ECG like~     electrodes on the skin, intracranial electrode mats or deep electrodes implemented surgically~     as part of clinical assessment. EIT recording will take place in parallel with the routine~     recording on the ward. Following completion of the recording, the EIT images will~     subsequently be analysed and compared to other imaging data for accuracy.~   "
39404|NCT03050918|"~     The goal of this project is to quantify the impact of post-hospital discharge follow-up phone~     calls on hospital readmission, ED visits, patient satisfaction, and mortality in a general~     medicine inpatient population. We will obtain exploratory information on patient sub-groups~     at high risk for hospital readmission and on those experiencing high benefit from the~     follow-up phone call intervention. In addition, we will obtain data on discharge plan~     implementation assistance needed to support a successful transition from inpatient to~     outpatient care among those reached by the intervention phone call.~   "
39405|NCT03050905|"~     HCV infection is one of the most prevalent etiologies for liver cirrhosis and hepatocellular~     carcinoma. HCV is highly heterogeneous, with seven confirmed major genotypes. Each genotype~     displays a different geographic distribution.~      Since different HCV genotypes react differently on available antiviral therapies, the correct~     identification of HCV genotype serves as a marker of responsiveness and an indicator for~     duration of treatment.~      The recombinant HCV genotype 2k/1b was first described in Saint Petersburg in 2002.~      A sequencing strategy led to the detection of HCV genotype 2k/1b. However, clinical~     laboratories often use the VERSANT HCV Genotype 2.0 Assay for routine HCV genotyping. This~     assay may potentially misclassify these HCV strains as genotype 2a/2c. Based on these~     findings, the number of patients with 2k/1b may be underestimated.~      AbbVie's IFN-free regimen for the treatment of chronic HCV genotype 1b infection includes 3~     DAAs with distinct mechanisms of action and non-overlapping resistance pattern to target HCV~     proteins essential for viral replication. The high efficacy of the 3D regimen was proven in~     registration clinical trials and RW for 1b population.~      3D regimen has not been evaluated for patients with HCV genotype 2K/1B. Primary Objective~      • Evaluate the efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir (3D) in an~     interferon-free treatment regimen as assessed by SVR in adult patients with HCV 2k/1b.~      Study Design:~      .The study will include 1 group. Patients with HCV GT 2k1b will be treated according to label~     recommendation as for GT1b (with and without cirrhosis) for 12 weeks. All subjects will~     receive Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir. Subjects will be assessed for~     antiviral response, clinical outcomes, patient reported adverse events and presence and~     emergence of resistance associated variants. Subjects will be followed for up to 12 weeks of~     treatment and extra 24 weeks of follow up. Scheduled visits will include: physician~     assessment and blood tests including HCV resistance mutations.~   "
39406|NCT03050892|"~     Evaluate the association between donor soluble protein ST2 (sST2) serum levels and 30-day~     recipient mortality in order to improve graft screening.~   "
39407|NCT03050879|"~     The purpose of this study is to explore the clinical outcomes of Indocyanine Green Tracer~     using in laparoscopic gastrectomy with lymph node dissection for gastric~     adenocarcinoma（cT1-4a, N-/+, M0）.~   "
39408|NCT03050866|"~     After failure on docetaxel, which has been the standard first line therapy for patients with~     metastatic castration-resistant prostate cancer (mCRPC), several treatment options are~     currently available.~      In retrospective studies, resistance has been described to two of the treatment options,~     enzalutamide and abiraterone, when a splice variant of the Androgen Receptor (AR-V7) is~     present on circulating tumor cells (CTCs). The investigators hypothesize that patients with~     AR-V7 positive CTCs do have a meaningful response to cabazitaxel.~   "
39409|NCT03050853|"~     This study will evaluate behavioral and psychological appeal, toxicity, and effect of~     e-cigarettes on smoking behavior and nicotine addiction in chronic smokers with serious~     mental illness (SMI) who have failed to quit smoking. A total of 240 participants will be~     enrolled and randomly assigned to either receive a supply of e-cigarettes for 8 weeks plus~     assessments (baseline & weeks 2, 4, 6, 8, 13, & 26) or assessments only. This single-blinded~     study will provide e-cigarettes and instructions on their safe use. Level of appeal will be~     inferred from carefully assessed use of e-cigarettes and reduction in combustible tobacco.~     Qualitative data will also be collected from participants assigned to e-cigarettes, given~     that unanticipated issues will almost certainly arise in connection with e-cigarette use that~     can only be captured within a qualitative debriefing at the conclusion of participants' time~     in the study.~   "
41833|NCT03019159|"~     The objective of the study is to determine whether tele-consulting for the follow up of~     patients with renal failure under peritoneal dialysis would not increase the risk of~     experiencing a severe adverse event~   "
39410|NCT03050840|"~     Obesity [Body mass index (BMI kg/m2 ≥ 95th percentile)] affects 1 in 5 adolescents in the~     United States, with 13 million suffering from severe obesity (BMI ≥ 120% > 95th percentile or~     ≥ 35 mg/kg2). Adolescents are able to lose weight with behavioral changes in diet and~     physical activity, but change in these behaviors requires self-monitoring and support, and~     weight loss is not always successful.~      Parent involvement and parent weight-loss can help their children to lose weight and~     successfully change their behavior. Guidance from pediatricians can also help to facilitate~     weight loss among obese adolescents. That said, treatment of obesity through behavior change~     within the time constraints of a Pediatric practice visit is limited by treatment adherence~     and clinic visit attendance. Therefore, finding cost-effective, timely, methods to keep~     adolescents with severe obesity engaged in therapy outside of standard practice is a critical~     need.~      The effects of monetary incentives through games (gamification), and a comprehensive remote~     digital monitoring system on sleep, physical activity, and dietary intake, has been~     successful in adults, but has not been tested in adolescents with obesity.~   "
39411|NCT03050827|"~     Investigators propose a placebo controlled, double blinded study to examine efficacy of~     topical Gelnique 3%TM (3% oxybutynin) daily for 20 weeks) in improving IENF density in type 2~     diabetic subjects with established peripheral neuropathy. This site most clearly demonstrated~     efficacy of topiramate in reversing IENF loss within 18 weeks in our prior study. Subjects~     will also undergo quantitative sensory testing (QST) and assays of laser Doppler skin blood~     flow (SkBF), neuropathy total symptom score (NTSS-6), and quality of life (Norfolk QOL-DN),~     along with standard measures of physiology and fasting blood chemistry. Subjects with IENF~     loss of between 20-75% of normative values and thus amenable to therapy-induced recovery,~     will be randomized into placebo (N=30) or active drug (N=30) arms and instructed in how to~     apply 84 mg Gelnique 3%TM or hydrogel placebo to cover a 2 in2 region of skin adjacent to the~     initial biopsy site, as per the manufacturers instructions (http://www.gelnique.com/gel3/).~     Treatment will continue daily for 20 weeks, with monthly phone calls to monitor compliance.~     After 20 weeks, subjects will return for a second series of measurements and 3 mm skin biopsy~     from the treated region of skin.~   "
39412|NCT03050814|"~     Background:~      Colorectal cancer is a common cancer in the U.S. It causes the second most cancer-related~     deaths. The drug avelumab and vaccine Ad-CEA together help the immune system fight cancer.~      Objective:~      To test if avelumab and Ad-CEA plus standard therapy treats colorectal cancer that has spread~     to other sites better than standard therapy alone.~      Eligibility:~      People ages 18 and older with untreated colorectal cancer that has spread in the body~      Design:~      Participants will be screened with:~      Test to see if their cancer has a certain deficiency~      Blood, urine, and heart tests~      Scans~      Medical history~      Physical exam~      Tumor sample. This can be from a previous procedure.~      A small group of participants will get Ad-CEA and avelumab plus standard therapy. This is~     FOLFOX plus bevacizumab for up to 24 weeks then capecitabine plus bevacizumab.~      The others will have treatment in 2-week cycles. They will be Arm A or B:~      Arm A: FOLFOX and bevacizumab by IV days 1 and 2 for 12 cycles. After that, capecitabine by~     mouth twice a day and bevacizumab by IV on day 1.~      Arm B: Ad-CEA injection every 2-12 weeks. Avelumab by IV on day 1 of each cycle. FOLFOX and~     bevacizumab by IV days 2 and 3 for 12 cycles. Then, capecitabine by mouth twice a day and~     bevacizumab through IV on day 2.~      Participants will repeat screening tests during the study.~      Participants will be treated until their disease gets worse or they have bad side effects.~     Arm A participants can join Arm B. They will have a visit 4 5 weeks after they stop therapy.~   "
39413|NCT03050801|"~     Background:~      Traumatic brain injury (TBI) damages the connections between brain cells. This can lead to~     problems like memory loss. Repetitive transcranial magnetic stimulation (rTMS) can help~     improve connections between brain areas in healthy people. Researchers want to see if it can~     be useful in patients with memory problems after TBI.~      Objective:~      To see how repetitive transcranial magnetic stimulation can be used to improve the~     connections between parts of the brain and whether this will lead to changes in memory.~      Eligibility:~      Adults 18-50 years old with TBI who can speak and write in English.~      Healthy volunteers the same age and English ability.~      Design:~      Participants will be screened with a neurological exam and may have a urine pregnancy test.~      Participants with TBI will have 7-15 visits. Healthy volunteers will have 2-8.~      At the visits, participants will have all or some of the following:~        -  MRI for about 1 hour. They will lie in a machine that takes pictures in a magnetic~          field. They will do some memory tasks.~        -  Memory and attention tasks with pictures and with a computer~        -  Questions about their mental state and well-being~        -  TMS: A wire coil is held on the scalp and a short electrical current passes through it.~          Participants will hear a click and feel a pulling or twitch. They may be asked to make~          simple movements. rTMS is repeated magnetic pulses in short bursts. They will have this~          for about 20 minutes.~      A week after the last visit, some participants will return for a memory test.~   "
39414|NCT03050788|"~     The investigators propose to evaluate a novel diagnostic approach for Kaposi's sarcoma (KS)~     that may be eventually deployed with portable, point-of-care techniques. This approach~     features confocal microscopy. The investigators will compare this new approach with the gold~     standard of histology from a traditional skin punch biopsy (which is standard of care) to~     determine the sensitivity and specificity of portable confocal microscopy in diagnosing KS.~   "
39415|NCT03050775|"~     The purpose of this study is to evaluate patients' temperatures after using one of two~     ventilator circuits (breathing systems): the ANAPOD™ Heat and Humidification System (ANAPOD™~     system) or the standard ventilator circuit with a heat-moisture exchanger (standard~     ventilator). The ANAPOD™ system will provide additional heat and humidity to patients through~     their breathing tube while the standard ventilator will not. The investigators are doing this~     research study to find out if the ventilator circuit providing additional heat and humidity~     will keep patients warmer during surgery and after surgery.~   "
39416|NCT03050762|"~     The goal of this data review study is to collect data to learn more about thyroid,~     parathyroid, and adrenal disease.~   "
39417|NCT03050749|"~     In this study, eligible patients with the medical indications (facial lipoatrophy,~     morphological asymmetry of the face, or debilitating scars) will be treated with Princess®~     VOLUME, and then will return for follow-up assessments 2, 4, 24, and 36 weeks after the~     treatment. A touch-up treatment may be done 2 weeks after the treatment if deemed appropriate~     by the Investigator.~   "
39421|NCT03050684|"~     Investigators will use dinoprostone(Propess TM) for cervix ripening and labor induction in~     term pregnant women.Vaginal pH base is achieved with the effect of hormones in pregnancy and~     associated with this, vaginal infections rates increase. With the vaginal application of~     Propess, the preparate remains in the vagina for a long time, with controlled~     release,creating a film layer against bacteria and especially fungal infections and it was~     thought that this could be a reason for unsuccessful birth induction by preventing release of~     this ovule.~      The aim of this study is to observe whether or not the rate of caesareans with the indication~     of unsuccessful induction was reduced in patients by reducing the density of vaginal bacteria~     and fungi with vaginal lavage and thereby increasing the effect of the drug and decreasing~     the rate of unsuccessful inductions.~   "
39422|NCT03050671|"~     This study aims to compare two different external calf compression devices applied in healthy~     individuals. These devices are commonly used in medical care in order to prevent the~     formation of blood clots, for example during immobilization after surgery. We aim to confirm~     the effects of external cyclic compression on healing and blood clotting and also to identify~     the one which is more effective.~   "
39423|NCT03050658|"~     Atopic dermatitis (AD) is a chronic allergic skin disease with onset in early childhood and~     increasing prevalence in Westernized countries. Current well newborn guidelines for washing~     babies with soap were adopted by U.S. hospitals in the 1970s, before the rise in prevalence~     of allergic disease and AD (also called eczema). Increased transepidermal water-loss (TEWL)~     in newborn skin at 2 days of life was recently identified as a predictor of AD and allergy~     development by age 2 years. Risk for AD in babies was also linked to decreased skin~     colonization with certain skin microflora, such as staphylococcal organisms. Together, these~     data raise the question of whether newborn skincare guidelines have the potential to modify a~     baby's risk for allergy development. Our current practice of washing babies with soap may~     alter TEWL or other natural factors in skin that protect babies from development of AD and~     allergy. More knowledge is needed about the impact of infant skincare practices on allergy~     development.~      The objective of this pilot study is to determine the impact of a baby's first bath on~     his/her transepidermal water loss (TEWL) and skin microflora. Study procedures will include~     collection of TEWL measurements and skin swabs for skin microflora analysis pre/post first~     bath in healthy term newborns at UVA. This data will serve as preliminary data for future~     studies.~   "
39424|NCT03050645|"~     Women with previous Gestational Diabetes Mellitus (GDM) are characterized by several~     metabolic abnormalities i.e. insulin resistance, beta-cell dysfunction and increased risk of~     later Diabetes Mellitus (DM). These latent disorders of glucose metabolism are demasked by~     the metabolic stress of pregnancy and as a routine, clinical assessment and measurement of~     HbA1c in addition to an oral glucose tolerance test (OGTT) is offered 3 months post partum.~      In this study, women with previous GDM and a control group matched on age, time of birth and~     BMI around 8 years after pregnancy will be investigated. Information from pregnancy and post~     partum examination (GDM only) will be used to identify risk factors for later development of~     DM. Further, life-style factors and mental health according to diabetes status will be~     studied.~   "
39425|NCT03050632|"~     The investigators are interested about the degree to which individuals can persist with~     individualized treatment goals when their cues (external such as food, or internal such as~     anxiety) are high for impulsive/maladaptive behavior (e.g., purging, not eating, etc.). The~     investigators want to find specific high-difficulty situations in which to assess whether~     participants remain mindful of the big picture and are willing to work toward therapeutic~     goals. Also, the investigators want to rate the participants degree of success (e.g.,~     proportion of calories eaten) assessed more objectively.~      The theory is that working memory capacity (WMC) modulates the ability to keep longer-term~     goals in mind when faced by current stress/temptations. For example, the ability to control~     drinking when one has an implicit urge to drink is predicted by WMC. The ability to apply a~     novel emotional regulation skill at a time of stress is also predicted by WMC. Indeed, the~     generic ability to pursue goals in the future (as assessed by the discounting of the value of~     future goals) is reliably predicted by WMC. There is also evidence that activation of brain~     regions associated with WMC (by direct activation of the dorsolateral prefrontal cortex via~     transcranial magnetic stimulation (TMS), or by having a person complete a relevant cognitive~     task) improves delay discounting.~      Accordingly, the investigators are proposing a study that both assesses the link between WMC~     and relevant the clinical measures noted above, as well as changes in these measures~     following activation of WM with a cognitive prime (WM task). The overall design calls for an~     initial WMC assessment, followed by randomization to complete 3 days of a WM prime and then 3~     days of a no prime group, or vice versa. The investigators then assess the clinical outcomes~     noted above across the following 6 days, with a WM prime first or no prime first occurring~     prior to the targeted behaviors. The investigators will prime WM prior to participant's~     evening meal, with the WM intervention offered during the free time before this meal.~   "
39426|NCT03050619|"~     Empagliflozin, a sodium glucose cotransporter 2 (SGLT-2) inhibitor, was launched in the~     United Kingdom (UK) in August 2014. It can be expected that patients initiating empagliflozin~     may differ in their characteristics from patients initiating other glucose lowering drugs~     (GLDs) that have been on the market longer (e.g. patients may have poorer glucose control).~     Therefore, the proposed study aims to characterize patients with T2DM in the UK initiating~     empagliflozin in terms of baseline characteristics, concomitant medications, and~     comorbidities compared to patients with type 2 diabetes mellitus (T2DM) initiating other~     SGLT-2 inhibitors or other non-insulin GLDs. Due to the mode of action, some patients taking~     empagliflozin have experienced weight loss in clinical trials. A theoretical possibility~     exists that empagliflozin may be used by patients without T2DM. Therefore, this study also~     aims to assess the potential off-label use of empagliflozin compared to other non-insulin~     GLDs.~   "
39427|NCT03050606|"~     Fibromyalgia is a rheumatologic disease characterized by generalized chronic pain,~     hyperalgesia and allodynia. Physical exercises are recommended as the first choice of~     non-pharmacological therapy. Thus, the purpose of this study is to evaluate the effectiveness~     and cost-effectiveness of modified Pilates method exercises compared to aerobic exercises in~     the treatment of patients with fibromyalgia. The hypothesis is that Pilates exercises will be~     as effective as aerobic exercise in the improvement of clinical outcomes, and that this~     improvement will be maintained over the medium to long term. It is also expected that aerobic~     exercises will be more cost-effective.~   "
39428|NCT03050593|"~     The investigators wish to test a hypothesis that patients with HFpEF have different~     characteristics on echo, cardiac MRI and plasma protein & chemical profiles compared to HFrEF~     and healthy volunteers.~   "
41082|NCT03029000|"~     A, multi-center, open-label, single-arm clinical study to assess effects of a 5-day regimen~     of 10 μg/kg of tbo-filgrastim administered sc daily on the mobilization of CD34+ cells in at~     least 60 healthy male and female donors. The pharmacokinetics, pharmacodynamics, safety,~     tolerability, and immunogenicity of tbo-filgrastim will be assessed .~   "
39429|NCT03050580|"~     This is cluster randomized control trial, that aims to evaluate the effectiveness of the~     treatment group model for abused women in enhancing their self-esteem and reducing the level~     of depression, in three shelters for abused women of Po Leung Kuk (a social service~     organization in Hong Kong). It is hypothesized that subjects in the Treatment Group would~     report significant improvement in self-esteem, social support, quality of life; reduction in~     the level of depression, symptoms of Posttraumatic Stress Disorder at 3 months after service~     delivery.~   "
39430|NCT03050567|"~     Hardening of the neck vessels (carotid arteries) caused by fatty deposits called 'plaques' is~     a common cause of strokes. Over time plaques can burst or may lead to a severe narrowing~     (stenosis) of the neck artery. When plaques burst, small clots or fatty particles (called~     microemboli) break off, block brain vessels and lead to a stroke. Researchers have an~     incomplete understanding of the processes that cause hardening of the arteries, development~     of small clots and are unable to predict who will have a stroke. At present, the only~     ultrasound scan that evaluates circulation in the head and detects these small clots is~     called the Transcranial Doppler ultrasound. The aim of the study is to test this simple~     ultrasound technique to see if it can detect signals that may correspond to these small clots~     or fatty particles. The other objective is to see how repeatable the ultrasound technique is.~     This may help to identify patients with hardened neck arteries who are at higher risk of a~     recurrent stroke. This could also potentially improve patients selection to a targeted~     surgical or future novel pharmacological therapy.~   "
39431|NCT03050554|"~     The purpose of the study is to determine whether avelumab has an effect on cancer and body in~     combination with SBRT, a standard treatment for early stage non-small cell lung cancer~     (NSCLC).~      Avelumab is considered experimental because it is not approved by the United States (U.S.)~     Food and Drug Administration (FDA) for the treatment of cancer. It is a type of drug called a~     monoclonal antibody (a type of protein). Monoclonal antibodies are made to recognize, target~     and bind to specific proteins on the cells that make up your tissues. Avelumab is designed to~     block the interaction between PD-1, a known immune checkpoint, and PD-L1. By blocking this~     interaction, the immune system may be stimulated, allowing it to more effectively recognize~     and attack the cancer.~      Stereotactic Body Radiation Therapy (SBRT) is a type of radiation that uses precise targeting~     to deliver a high dose of radiation to the tumor over a short period of time. A positioning~     cushion such as Vac-lok will be used during radiation treatment that is custom made. This~     custom mold forms to the contours of the subjects body to allow for proper positioning~     comfort and stability.~   "
39432|NCT03050541|"~     The purpose of this study is to examine the effects of MDMA on encoding and retrieval of~     emotional and social memories in healthy young adults. The study will explore the effects on~     memory retrieval when the drug is administered 1) before encoding, and 2) before retrieval.~   "
39433|NCT03050528|"~     The aim of this study is to evaluate the effectiveness of a combined Exercise and Acceptance~     and Commitment Therapy (ACT) programme, compared to a standalone supervised exercise~     intervention for patients with chronic pain. Chronic pain is a common problem, which can have~     a significant impact on quality of life. While there are many treatments available for~     chronic pain, research has shown that improvements are often modest and short-term.~      Exercise therapy is known to be helpful for many chronic conditions and is recommended in~     clinical guidelines for the management of chronic pain. Acceptance and Commitment Therapy~     (ACT) is a form of psychological therapy, which focuses on improvement of function, rather~     than symptom reduction. There is an emphasis on psychological flexibility, values and~     mindfulness. This approach may be well suited to chronic pain, where symptoms can be beyond a~     person's control, but there is a need for further research, particularly with regards to~     combining ACT with a physical intervention.~      This study will take place in a Dublin University hospital. Patients will be randomly~     allocated to a combined exercise and ACT treatment group or a standalone exercise group. Both~     groups will have weekly treatment for eight weeks and will be assessed before and after~     treatment, and again twelve weeks later. Questionnaires will be used to measure the effects~     of the treatment on the degree to which pain interferes with various aspects of daily life.~     Activity trackers will be worn to measure daily physical activity levels. A purposeful sample~     of participants from both groups will also be invited to participate in a qualitative study~     following treatment.~   "
39434|NCT03050515|"~     Recurrent urinary tract infections are quickly becoming a public health obstacle in our aging~     population. Almost 50% of women have at least one urinary tract infection in their lifetime;~     following this first infection, there is a 25-35% chance that she will have another infection~     in the subsequent 3-6 months. With each documented infection, a patient receives anywhere~     from a three to seven day course of antibiotics for treatment. Repeated courses of~     antibiotics often lead to the development of multi-drug resistant infections that are~     difficult to treat with our arsenal of oral medications. It is theorized that most, if not~     all, urinary tract infections are caused by bacteria from the gastrointestinal tract. If~     there is a generalized gut dysbiosis due to repeated courses of oral antibiotics, it will~     likely be difficult to ever adequately treat repeat urinary tract infections. This same~     theory led to the development and utilization of fecal microbiota transplantation in the~     treatment of refractory Clostridium difficile diarrhea. There are now several studies that~     have reported on the efficacy of fecal transplantation in the treatment of C.difficile~     infections as well as the correction of gut dysbiosis. Given this positive response in~     treatment of refractory infectious diarrhea, the investigators propose that the correction of~     gut dysbiosis can also treat refractory recurrent urinary tract infections. Therefore, the~     investigators propose this pilot study to determine the effectiveness of fecal~     transplantation in the treatment of refractory, recurrent urinary tract infections.~   "
39451|NCT03050294|"~     Psoriasis and atopic dermatitis are chronic inflammatory disease that account for a~     significant amount of patients in most dermatological practices. Topical corticosteroid~     agents are often prescribed for treatment of both these conditions, especially when they are~     localized rather than wide spread. The development of resistance to treatment is termed~     tachyphylaxis. Poor adherence, rather than down regulation of receptors, may be the primary~     cause of tachyphylaxis to topical corticosteroids. The primary objective of the study is to~     determine, under conditions designed to assure good adherence, whether topical 0.25%~     desoximetasone spray improves clinical outcomes in patients who have resistant inflammatory~     skin disease defined by failure of previous topical steroid treatment.~   "
39435|NCT03050502|"~     Chest injuries are common in patients with polytrauma and are responsible for approximate 25%~     of all trauma-related mortalities. Traumatic injuries to the thorax often result in the~     accumulation of blood within the chest (i.e. a hemothorax (HTX)). The management of HTX~     remains a clinical dilemma when the volume of blood is small to moderate and the patient is~     hemodynamically stable. The East American Association of Trauma guidelines suggest that all~     HTXs should be considered for chest tube drainage. However, a prospective observational study~     suggested small to moderate HTXs could be absorbed without intervention. Although HTXs are~     effectively managed with chest tube drainage of the blood (i.e. tube thoracostomy), this~     intervention is associated with numerous potential major complications, including injury and~     infection in up to 22% of patients. The purpose of this study is therefore to conduct a~     randomized controlled study to compare patients with traumatic HTX managed by chest tube~     drain or expectant management (close monitoring), to determine when a chest tube is needed~     and when it is not to treat hemothoraces. The results from this study will inform the care of~     future trauma patients who present with this common injury throughout the globe.~   "
39436|NCT03050489|"~     Assessment of myocardial ischemic-reperfusion injury during off- and on- pump CABG.~   "
39437|NCT03050476|"~     Study should demonstrate that alkaline phosphatase reduces the incidence and extent of acute~     kidney injury after cardiopulmonary bypass (CPB) as defined by the AKIN criteria.~   "
39438|NCT03050463|"~     The investigators hope to gain a better understanding of the influence of affect reactivity~     and regulation on the decision of newly diagnosed breast cancer patients to choose bilateral~     mastectomy. The information gained can help develop an intervention to enable management of~     cancer-related anxiety by non-surgical means.~   "
39439|NCT03050450|"~     Independently, both lenalidomide and vorinostat have shown promising activity in pediatric~     central nervous system tumors. These are both agents that are not typically part of~     first-line studies, although both agents are of serious interest and are currently in~     clinical trials for further investigation. This study is to evaluate the combination of~     lenalidomide and vorinostat in high grade or progressive central nervous system tumors in~     children.~   "
39440|NCT03050437|"~     It has not been established whether platinum-based doublets is better than single agent~     chemotherapy in EGFR mutant NSCLC patients who failed first-line EGFR TKI.~      In this prospective trial, the investigators try to evaluate whether the progression-free~     survival of pemetrexed/cisplatin (PC) regimen is longer than that of pemetrexed single(P)~     regimen in NSCLC patients who have progressed after first line treatment of EGFR-TKI.~   "
39441|NCT03050424|"~     This phase II single centre, double blind, placebo-controlled, randomised trial aims to test~     the hypothesis that intravenous iron improves exercise performance in Chronic Obstructive~     Pulmonary Disease (COPD) as measured by constant rate cycle ergometry.~   "
39442|NCT03050411|"~     Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs), including gefitinib~     demonstrate excellent effect on the treatment of non-small cell lung cancer (NSCLC) patients~     with EGFR mutations. However, patients who are initially sensitive to the drugs eventually~     become resistance. Apatinib is a highly selective VEGFR2 inhibitor and reduces the~     angiogenesis of tumor efficiently. In this study, the investigators aim to explore the~     efficacy and reasonable dosage of apatinib combining with EGFR-TKI in advanced non-squamous~     non-small cell lung cancer with EGFR-TKI resistance.~   "
39443|NCT03050398|"~     This study will allow for the collection of tumor tissue samples to better understand~     relevant mutations and the mechanisms responsible for resistance to treatment.~   "
39444|NCT03050385|"~     The purpose of this study is to explore whether active transcranial direct current~     stimulation during cognitive rehabilitation tasks can boost cognitive enhancement without~     severe side effects in mild cognitive impairment or mild dementia patients.~   "
39445|NCT03050372|"~     Participants will be recruited and screened through ongoing studies in the sleep and anxiety~     disorders clinic. Participants with insomnia will be consented to complete several~     questionnaires, undergo a brief physical exam, provide a urinalysis, and undergo 5 nights of~     active or sham Low Field Magnetic Stimulation (LFMS) followed by an overnight sleep study.~     Each of the two treatment conditions (active versus sham) will be conducted on two~     consecutive nights. There will be no more than 7 days between the adaptation night and the~     first treatment condition and no more than 7 nights between each of the two-night treatment~     conditions . Thus, each participant who completes the full study will spend a total of 5~     nights in the sleep laboratory and the time interval from the first adaptation night to~     completion of the study may range from 5-19 days for any particular individual.~   "
39446|NCT03050359|"~     The purpose of this study is to demonstrate the non-inferior efficacy of TAK-438 versus~     lansoprazole in the treatment of participants with duodenal ulcer.~   "
39447|NCT03050346|"~     This is a clinical trial to test the clinical feasibility and safety of a novel CMR protocol,~     combined with a specific breathing maneuver to identify myocardial regions exposed to severe~     coronary artery stenosis.~   "
39448|NCT03050333|"~     An observational, prospective, multicentre and international study. This will be a~     non-interventional study to evaluate the efficacy and safety of endoscopic resection of~     gastrointestinal lesions and to determine what are the factors related to complications, and~     to describe these lesions according to the different morphologic and histologic~     classifications.~   "
39449|NCT03050320|"~     The purpose of this study is to examine the impact of an OA-specific aerobic and~     strengthening exercise program, delivered within the workplace, on mobility, pain, physical~     capacity, and resilience among workers with knee or hip OA as well as those with no joint~     pain. The investigators hypothesize that exercise designed for OA, delivered at work, will~     improve all of these outcomes.~   "
39450|NCT03050307|"~     The purpose of this study is to demonstrate the non-inferior efficacy of TAK-438 versus~     lansoprazole in the treatment of participants with gastric ulcer.~   "
39463|NCT03050138|"~     The primary objective in this cross-sectional study is to assess the prevalence of~     post-thrombotic syndrome (PTS) in the two treatment arms of the RE-COVER studies (warfarin~     versus dabigatran). PTS will be assessed by the recently developed Patient Reported Villalta~     (PRV) Score.~      Secondary objectives: to assess in both treatment arms the~        1. Prevalence of recurrent venous thromboembolism (VTE) after the discontinuation of study~          treatment.~        2. Prevalence of PTS determined by the standard Villalta score.~        3. Health related Quality of Life (HRQoL).~   "
39452|NCT03050281|"~     Background: The use of simulation and cadaveric laboratory training are highly beneficial for~     faculty and advanced trainees, but its usefulness for third-year medical students rotating~     through OB-GYN or general surgery is unknown.~      Objective: To determine if a two-day intensive, cost-effective review of procedural skills~     and anatomy using the simulation laboratory and cadaver-based dissection improves performance~     of third-year medical students on the National Board of Medical Examiners (NBME) Shelf and~     USMLE Step 2 board examination and during pre- and post-test demonstrations.~      Significance: If proven effective, implementation of a short, inexpensive, and comprehensive~     course highlighting anatomical and procedural skills during the third year of medical school~     could be implemented.~      Design Methods: The investigators will conduct a 1:1 randomization of third-year medical~     students rotating at all Mayo sites (Jacksonville, Rochester, and Scottsdale). The students~     will either participate in traditional education (N=20) as is currently taking place or~     traditional education plus cadaver-based/simulation-based learning (N=20). Third-year medical~     students rotating in OB-GYN or surgery will be eligible to enroll.~      Anticipated Outcomes: Knowledge-based examination results as well as performance outcomes~     will be improved and procedural skills and overall satisfaction will be increased.~   "
39453|NCT03050268|"~     NOTE: This is a research study and is not meant to be a substitute for clinical genetic~     testing. Families may never receive results from the study or may receive results many years~     from the time they enroll. If you are interested in clinical testing please consider seeing a~     local genetic counselor or other genetics professional. If you have already had clinical~     genetic testing and meet eligibility criteria for this study as shown in the Eligibility~     Section, you may enroll regardless of the results of your clinical genetic testing.~      While it is well recognized that hereditary factors contribute to the development of a subset~     of human cancers, the cause for many cancers remains unknown. The application of next~     generation sequencing (NGS) technologies has expanded knowledge in the field of hereditary~     cancer predisposition. Currently, more than 100 cancer predisposing genes have been~     identified, and it is now estimated that approximately 10% of all cancer patients have an~     underlying genetic predisposition.~      The purpose of this protocol is to identify novel cancer predisposing genes and/or genetic~     variants. For this study, the investigators will establish a Data Registry linked to a~     Repository of biological samples. Health information, blood samples and occasionally leftover~     tumor samples will be collected from individuals with familial cancer. The investigators will~     use NGS approaches to find changes in genes that may be important in the development of~     familial cancer. The information gained from this study may provide new and better ways to~     diagnose and care for people with hereditary cancer.~      PRIMARY OBJECTIVE:~        -  Establish a registry of families with clustering of cancer in which clinical data are~          linked to a repository of cryopreserved blood cells, germline DNA, and tumor tissues~          from the proband and other family members.~      SECONDARY OBJECTIVE:~        -  Identify novel cancer predisposing genes and/or genetic variants in families with~          clustering of cancer for which the underlying genetic basis is unknown.~   "
39454|NCT03050255|"~     Although exercise-induced desaturation is frequently observed in patients with idiopathic~     pulmonary fibrosis (IPF) short-term effects of supplemental oxygen during walking have not~     been investigated yet. Given, that walking ability is the most important activity of daily~     life, the aim of our study is to investigate the effects of supplemental oxygen on endurance~     walking capacity in hypoxemic IPF patients. In this study patients will perform 3 endurance~     shuttle walk tests (ESWTs) at 85% of their individual peak performance using medical air~     (=compressed room air, 2 liters/minute), 2 liters/minute oxygen, 4 liters/minute Oxygen in a~     double-blinded fashion and random order.~      Since there are only limited pharmacological treatment options for IPF patients, this study~     may help to provide novel information about the short-term effects of supplemental oxygen.~     Furthermore it may help to investigate possibilities to optimize oxygen therapy in order to~     facilitate patients´ participation in activities of daily life and not at least to improve~     patients´ quality of life.~   "
39455|NCT03050242|"~     This study is intended to evaluate the efficacy and safety of glycopyrrolate as an~     antisialagogue prior to intubation with the rigid-videostylet(Optiscope®) in the general~     anesthesia settings. Upper airway secretions limit the use of the videostylet during during~     endotracheal intubation. Therefore, in this study, patients will be allocated to either of~     the two groups according to the administration of glycopyrrolate and the effect of~     glycopyrrolate in reducing oral secretions will be assessed by the observer while intubating~     with the rigid-videostylet. The efficacy of the antisialagogic effect on the view during~     endotracheal intubation will be evaluated.~   "
39456|NCT03050229|"~     To explore the beneficial effects of 'empagliflozin + ARB' in comparison with 'placebo + ARB'~     on the reduction of nocturnal blood pressure in T2DM with hypertension~   "
39457|NCT03050216|"~     This is a multi-institutional Simon's optimal two-stage phase II trial of CD3/CD19 depleted,~     ALT-803 activated, haploidentical donor NK cells and subcutaneous ALT-803 given after~     lymphodepleting chemotherapy (CY/FLU) for the treatment of refractory or released acute~     myelogenous leukemia (AML).~   "
39458|NCT03050203|"~     Recent evidence suggests the efficacy of custom pack procedure on the operators reduction~     time and on the contamination risk due to the opening of many sterile packs. Nevertheless~     ,the studies available are sponsored by the industry and their results are very few. The aim~     of this study is to evaluate the correlation and reliability of spine surgery custom pack~     efficacy in adult patients obtained in the reduction of surgery time, relative risks, and~     materials wasted compared with the standard surgical field procedure practice .~   "
39459|NCT03050190|"~     The study will evaluate safety and efficacy of a 4th generation chimeric antigen receptor~     gene-modified T cells targeting CD19 (4SCAR19) for patients with B cell malignancies.~     Clinical response and development of a standardized lentiviral vector and cell production~     protocol will be investigated. This is a phase I/II trial enrolling patients from multiple~     clinical centers.~   "
39460|NCT03050177|"~     The study design is an Open-Label，Randomized, Single-Dose, 2-way Crossover Bioequivalence~     Study. During each session, the subjects will be administered a single dose of 250mg~     Gefitinib Tablet (one Gefitinib Tablet 250mg of Hunan Kelun or one Iressa® Tablet 250mg of~     AstraZeneca) under fed conditions.~   "
39461|NCT03050164|"~     The study design is an Open-Label，Randomized, Single-Dose, 2-way Crossover Bioequivalence~     Study. During each session, the subjects will be administered a single dose of 250mg~     Gefitinib Tablet (one Gefitinib Tablet 250mg of Hunan Kelun or one Iressa® Tablet 250mg of~     AstraZeneca) under fasting conditions.~   "
39462|NCT03050151|"~     To collect data on actual-use to assess technical performance and user injections of~     dupilumab auto-injection device by patients with atopic dermatitis (AD).~   "
39464|NCT03050125|"~     This pilot study will investigate the impact of sterile saline drops that are formulated at~     hypo-osmolar levels on CL comfort in comparison to an iso-osmolar drop, in a group of~     symptomatic CL wearers.~   "
39465|NCT03050112|"~     Adults with a congenital heart disease, having undergone a surgical intervention or a re-do~     surgery in adulthood, are a growing group of subjects in the general population. This~     increase is explained by improved medical and surgical techniques, with a better survival~     rate as outcome.~      There is nowadays a growing interest in the quality of life of this group of subjects.~     However, studies give contradictory results. This can be explained on one hand by the vast~     majority of pathologies within this population, and on the other hand by the absence of a~     cardio-specific tool for quality of life measurement.~      The MacNew questionnaire is cardio-specific. It allows an evaluation of the quality of life~     based on the exploration of three domains: physical, emotional and social.~      The aim of this study is:~        -  to evaluate the quality of life of these patients, by using the MacNew questionnaire~        -  to explore the needs in terms of prevention, treatment and multi-disciplinary follow-up~        -  to assess the mortality within this group of patients.~   "
39466|NCT03050099|"~     A multi-protein test using mass spectrometry (MS) for multiplexed protein quantitation is~     being developed. This test and the accompanying decision-aid software will provide Transient~     Ischemic Attack (TIA) results rapidly for a fraction of the price of neuroimaging. With~     guidance provided by this test, Emergency Department (ED) physicians can manage medical~     imaging questions such as the use of Computed Tomography Angiography (CTA) prior to ED~     discharge and appropriate (timely) referral to stroke clinics for consultation and follow-up~     care. The right patients will receive the right treatment, reduce unwarranted imaging risks~     and costs, and reduce the burden of stroke.~   "
39467|NCT03050086|"~     An open label feasibility study using BPX-04 topical minocycline gel in papulopustular~     rosacea.~   "
39468|NCT03050073|"~     A chinese study shows that chinese population eyes with a primary angle closure have a~     greater choroidal thickness than normal eyes.The increase of choroidal thickness would be~     associated to this primary angle closure.~   "
39469|NCT03050060|"~     This phase II trial studies how well image guided hypofractionated radiation therapy works~     with nelfinavir mesylate, pembrolizumab, nivolumab, and atezolizumab in treating patients~     with melanoma, lung cancer, or kidney cancer that has spread. Hypofractionated radiation~     therapy delivers higher doses of radiation therapy over a shorter period of time and may kill~     more tumor cells and have fewer side effects. Nelfinavir mesylate may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies,~     such as pembrolizumab, nivolumab and atezolizumab, may interfere with the ability of tumor~     cells to grow and spread. Giving hypofractionated radiation therapy, nelfinavir mesylate,~     pembrolizumab, nivolumab and atezolizumab may work better in treating patients with melanoma,~     lung, or kidney cancer.~   "
39470|NCT03050047|"~     A Multicenter Open-Label Single-Arm Multi-Cohort Phase I Study of Pharmacokinetics,~     Pharmacodynamics, Safety, and Immunogenicity of BCD-100 (JSC BIOCAD, Russia) in Patients with~     Advanced Solid Tumors~   "
39471|NCT03050034|"~     The present study was planned to provide clinical data on the impact of acute and critically~     ill patients in Internal Medicine Unit activity and economic data enabling to quantify the~     relative cost of acute patients management during ordinary hospitalization. In these~     critically ill complex patients the vital parameters continuous monitoring could help in~     improving the quality of care. Therefore, the study will check how the wireless continuous~     monitoring in acute selected patients is able to reduce major complications improving the~     patient's outcome and the quality of care and reducing costs compared to traditional~     monitoring performed at regular intervals by the nursing staff.~   "
39472|NCT03050021|"~     Delirium is characterized by changes in mental status, inattension, disorganized thinking,~     and altered consciousness. Prevalence of delirium in critically ill patients has varied from~     20~80% depending on the severity of illness. Despite its high prevalence, delirium is often~     under-recognized by clinicians due to the difficulties in diagnosis and no interest. Delirium~     is associated with increased mechanical ventilation days, hospital length of stay, and~     mortality. The purpose of this study is to analyze the prevalence of delirium and risk~     factors for delirium in critically ill surgical patients.~   "
39473|NCT03050008|"~     Despite the advantages already demonstrated by FLACS, these surgeries still require~     ultrasonic devices for fragmentation of the lens. The ultrasonic energy used during~     phacoemulsification may induce complications such as reduction of endothelial cells and~     corneal edema. In this sense, it would be beneficial to develop surgical techniques that~     eliminate the need for ultrasound. The group of surgeons of Alfredo Tranjan Ophthalmic~     Center, recently developed a surgical technique of cataract that optimizes the use of the~     laser, eliminating the need for ultrasound during the surgical procedure. Thus, the~     crystalline fragmentation process does not involve ultrasound being performed by the laser~     itself. It is expected that this procedure will reduce the complexity of cataract surgery,~     and be safer in terms of potential corneal lesions. The present study intends to evaluate the~     benefit and safety of FLACS without use of ultrasound (USFREE), compared to traditional~     phacoemulsification surgery using ultrasound in patients with senile cataract. In this sense,~     it is intended to primarily compare the volume of balanced saline solution (BSS) between~     surgeries.~   "
39483|NCT03049878|"~     Objectives:~      The aim of this study was to determine the effectiveness of preoperative administration of~     single-dose of paracetamol-codeine, in the relieving of acute post-operative pain after the~     surgical removal of an impacted mandibular third molar.~      Materials and Methods:~      The study cohort consisted of 32 Caucasian outpatients, giving a total of 64 bilateral~     symmetrical impacted mandibles. Patients were randomized in two experimental groups to~     receive a preoperative oral dose of paracetamol-codeine (analgesic group) or a placebo~     (placebo group) at the first and second surgeries. Study participants were asked to record~     pain intensity scores during the operation and the next 2 days, the time of the first request~     for rescue analgesic, and the total number of postoperative-supplement paracetamol-codeine~     tablets.~   "
39484|NCT03049865|"~     The principal aim is to assess if a simple test, the time it takes to walk 10 meters for a~     patient about to be discharged after a hospital stay for an acute illness, is related to the~     risk of readmission.~   "
39485|NCT03049852|"~     1. CBT-001 administered three times daily (TID) for 4 weeks has an acceptable safety~          profile when used in pterygium patients~        2. CBT-001 administered TID for 4 weeks is more effective than the vehicle in reducing~          pterygium vascularity and inhibiting pterygium lesion growth~        3. CBT-001 administered as topical ocular dosing displays negligible systemic drug exposure~   "
39474|NCT03049995|"~     Background: Stress echocardiography (SE) has an established role in evidence-based~     guidelines, but recently the breadth and variety of applications has extended well beyond~     coronary artery disease (CAD). Purpose: To establish a prospective research study of SE~     applications, in and beyond CAD, also considering a variety of signs in addition to regional~     wall motion abnormalities. Methods: In a prospective, multicenter, international,~     observational study design, > 100 certified high-volume SE labs will be networked with an~     organized system of clinical, laboratory and imaging data collection at the time of physical~     or pharmacological SE, with structured follow-up information. The study is endorsed by the~     Italian Society of Echocardiography and organized in 10 subprojects focusing on: contractile~     reserve for prediction of cardiac resynchronization or medical therapy response; stress~     B-lines in heart failure; hypertrophic cardiomyopathy; heart failure with preserved ejection~     fraction; mitral regurgitation after either transcatheter or surgical aortic valve~     replacement; outdoor SE in extreme physiology; right ventricular contractile reserve in~     repaired tetralogy of Fallot; suspected or initial pulmonary arterial hypertension; coronary~     flow velocity, left ventricular elastance reserve and B-lines in known or suspected CAD;~     identification of subclinical familial disease in phenotype-negative healthy relatives of~     inherited disease (such as hypertrophic cardiomyopathy). Expected Results:To collect about~     10,000 patients over a 5-year period (2016-2020), with sample sizes ranging from 5,000 for~     known or suspected CAD to around 250 for hypertrophic cardiomyopathy or repaired Fallot. This~     data base will allow to investigate technical questions such as feasibility and~     reproducibility of various SE parameters and to assess their prognostic value in different~     clinical scenarios. Conclusions: The study will create the cultural, informatic and~     scientific infrastructure connecting high-volume, accredited SE labs, to obtain original~     safety, feasibility, and outcome data in evidence-poor diagnostic fields, also outside the~     established core application of SE in CAD based on regional wall motion abnormalities. The~     study will standardize procedures, validate emerging signs, and integrate the new information~     with established knowledge, helping to build a next-generation SE lab without inner walls.~   "
39475|NCT03049982|"~     The purpose of the study is to test the workflow of an auto-titrating mandibular positioner~     in its intended setting. Participants with obstructive sleep apnea will use the device to~     determine their eligibility for oral appliance therapy and provide feedback on usability of~     the device.~   "
39476|NCT03049969|"~     The proposed study will test the feasibility and tolerability of transcranial direct current~     stimulation (tDCS) added to a cognitive remediation program in n=100 adults. For 20 cognitive~     remediation sessions, participants will receive 20 minutes of active tDCS stimulation (up to~     2.0 mA, dorsolateral prefrontal cortex or DLPFC montage) while they complete the cognitive~     training tasks.~   "
39477|NCT03049956|"~     Myasthenia gravis is an autoimmune disorder of neuromuscular transmission, characterized by~     fluctuating muscle weakness and fatigability. In isolated ocular myasthenia, when only the~     extraocular muscles are involved, most common ancillary tests, such as acetylcholine receptor~     autoantibodies and repetitive nerve stimulation, are often negative.~      A simple, quick and non-invasive test for ocular myasthenia based on ocular vestibular evoked~     myogenic potentials (oVEMP) was recently developed.~      The main goal of the study is to validate repetitive oVEMP stimulation in a blinded~     diagnostic accuracy study in order to facilitate early and accurate diagnosis of ocular~     myasthenia.~   "
39478|NCT03049943|"~     The aim of this study was to compare the effects of different wave lengths of LLLT on~     salivation in participants suffering from hyposalivation.~      This study included 30 participants whose major salivary glands were treated with low~     intensity diode laser BTL2000 (Medical Technologies, s.r.o., Czech Republic) during 10~     consecutive days. Patients were randomly assigned in two groups, each of 15 patients, and~     treated with LLLT of 830 nm and LLLT of 685 nm, respectively. The whole unstimulated and~     stimulated saliva was measured each day during 10 days, before and after laser treatment and~     10th day after treatment was ended.~   "
39479|NCT03049930|"~     The purpose of this study is to determine whether a low-dose ketamine infusion can be used as~     the main intra-operative analgesic in different burn patients, and thereby reduce the total~     intra-operative opioid requirement. Secondary objectives are to determine whether this~     low-dose ketamine infusion will lengthen the amount of time to the first narcotic given in~     the recovery room or ICU, and whether pain scores for awake patients will be lower~     post-operatively.~   "
39480|NCT03049917|"~     The purpose of this study is to determine whether giving small financial incentives will~     motivate parents to test their children for HIV.~   "
39481|NCT03049904|"~     This is a pilot study of the feasibility of the virtually reality, online, culturally~     grounded HIV prevention intervention for Native American men who have sex with men. The~     project will include 90 Native American men who have sex with men (MSM) from across the~     continental United States as well as Alaska and Hawaii.~      The investigators will use a randomized clinical trial with a waitlist control condition to~     evaluate the intervention's impact on HIV / Sexually Transmitted Infections (STI) testing~     behavior, condom use, and substance use harm reduction. Specifically, investigators will ask~     participants to spend 3 weeks exploring a virtual reality environment hosted in the Second~     Life® platform. The island consists of 3 levels: Learning Level, Skills building level, and~     Experiential level.~      In the Learning level the participant's avatar will have the opportunity to attend up to 2~     free Motivational Interviewing sessions to establish their goals for their time on the~     island. Additionally, they will explore 4 learning paths each covering a knowledge objective:~     HIV Testing, Condom Use & Condom Use Negotiation, Safer Sex, and Harm Reduction. Each path~     will present knowledge via videos, interactive games, stories, and teachings. After~     completing level 1, participants will move on to the Skills building level. Here participants~     will have the opportunity to role play scenarios (e.g., obtaining an HIV test, requesting~     PrEP from their doctor, negotiating condom use) with pre-program virtual actors. All~     scenarios are based on the knowledge gained in the Learning Level. Participants will also~     engage on mini-quests for additional knowledge and in-world rewards. Finally, in the third~     level participants will be able to practice the skills learned in interactions with other~     participants' avatars.~      If efficacious, this online HIV prevention intervention has the potential for widespread~     dissemination and could be particularly helpful for rural and reservation-based Native MSM~     who often have difficulty accessing services and support.~   "
39482|NCT03049891|"~     The decentralization study will describe children taking antiretroviral therapy (ART) at a~     larger health facility in the Eastern Cape province of South Africa, between the years of~     2004-2013. The study will be conducted at Dora Nginza Hospital (DNH). The study will measure~     how many children stay in care and how many die, as well as their health status. The study~     will also compare whether children do better if they stay in care a large hospitals or if~     they get health care at smaller clinics. A second part of the study will find children in the~     community who have stopped coming for health care and find out what happened to them and what~     their health status is.~   "
39486|NCT03049839|"~     The main aim of this study is to evaluate the feasibility and effectiveness of a program for~     modifying lifestyles for diabetes prevention type 2 and control cardio-metabolic risk factors~     in adults with different categories of risk from the primary health care strategy.~      The project will show the effect of these interventions for the first time in people With~     different risk of developing type 2 diabetes throughout the life in populations living in~     Colombia Located in 2 different cities, one of them in the interior of the country (districts~     of Bogota) and another in the north coast (districts of Barranquilla) .~   "
39487|NCT03049826|"~     Background: There are few studies about nutrition to children and adolescents with cancer,~     and in particular during stem cell transplantation (SCT). Studies from other countries~     suggest that malnutrition is common on admission; the situation decline during treatment and~     may persist for a long time.~      Aim: This project aims to improve the nutritional therapy to children being treated for~     cancer and children undergoing stem cell transplantation~   "
39488|NCT03049813|"~     This is a randomized controlled trial to evaluate the community-based effectiveness of~     virtual reality job interview training (VR-JIT). Northwestern University is partnering with~     Thresholds Inc. to evaluate the effectiveness of VR-JIT at improving interviewing skills and~     access to employment. In addition, we will evaluate the cost effectiveness of VR-JIT and the~     process for implementing VR-JIT at Thresholds.~   "
39489|NCT03049800|"~     The purpose of this study is to perform longitudinal high-resolution 7T MRI in participants~     with first-episode psychosis (FEP) enrolled in our ongoing randomized controlled clinical~     trial (RCT) of cognitive training. The investigators seek to determine whether a 12-week~     course of intensive cognitive training of auditory processing in young FEP patients delivered~     remotely as a stand-alone treatment is neuroprotective against neural tissue loss in auditory~     cortex (superior temporal gyrus, STG), and possibly in other cortical regions. The~     investigators will also observe the effects of training on white matter integrity in the~     brain.~   "
39490|NCT03049787|"~     This study aims to evaluate physical therapy (standard of care) and home exercise vs. home~     exercise alone for the treatment of adhesive capsulitis.~   "
39491|NCT03049774|"~     The aim of this retrospective study is to review and describe the safety and the efficacy of~     recombinant human interleukin-11 (I) i (Baijieyi), using information already recorded in 20~     medical records, The time periods include May 8th of 2008 to december 31st of 2016.~   "
39492|NCT03049761|"~     Evaluation of the Safety of a Water Flosser on Gingival and Epithelial Tissue at Different~     Pressure Settings~   "
39493|NCT03049748|"~     The purpose of this study is to evaluate the use of VAD Care App in an out-patient mechanical~     circulatory support program. The specific aim for this pilot study is to obtain preliminary~     efficacy data of the VAD Care App as a self-management tool for patients with long-term~     LVADs. A randomized control trial will be employed to establish preliminary estimates of the~     effects of the App on the following outcomes: (1) patients' and caregivers' self-efficacy and~     (2) adherence to the LVAD care regimen; (3) LVAD-related complications and health care~     utilization [e.g., hospital re-admission]; and (4) the patients' overall health status and~     (5) quality of life. The duration of the study is 6 months.~   "
39494|NCT03049735|"~     The purpose of this study is to determine the benefit and safety of relugolix 40 mg once~     daily co-administered with low dose estradiol and norethindrone acetate compared with placebo~     for 24 weeks on heavy menstrual bleeding associated with uterine fibroids. Additionally, this~     study is designed to evaluate the benefit of relugolix 40 mg once daily for 12 weeks followed~     by 12 weeks of relugolix 40 mg once daily co-administered with low dose estradiol and~     norethindrone acetate compared with placebo for 24 weeks in the same population.~   "
39495|NCT03049722|"~     The purpose of this study is to collect clinical data for the development and evaluation of a~     new device feature for automatic AV-delay (AVD) optimization.~   "
39496|NCT03049709|"~     There is growing evidence that central blood pressure is a better predictor of hypertensive~     end-organ damage and cardiovascular outcome than routine brachial readings.~      The investigators aimed to evaluate the accuracy of a novel device for the non-invasive~     determination of central blood pressure based on automated oscillometric radial pulse wave~     analysis.~   "
39497|NCT03049696|"~     The primary objective of the study is to determine whether participation in a pre-bariatric~     surgery physical activity and behavior modification/education program (ENCOURAGEING START)~     that is tailored to the unique needs of obese bariatric surgery patients, improves physical~     fitness, surgical outcomes, patient health and quality of life. Short- (one year) and long-~     (five year) term outcomes will be compared to matched historical controls (1:1) based on age,~     gender, and body mass index (BMI) from the existing Manitoba Centre for Metabolic and~     Bariatric Surgery (CMBS) database. Our findings will determine whether a pre-bariatric~     surgery physical activity and behavior modification/education program results in improve~     surgical and patient outcomes and inform the development of evidence-based physical activity~     (PA) guidelines for bariatric surgery patients and improved CMBS program delivery.~   "
39498|NCT03049683|"~     To lower the threshold for clinical application by reducing the testing time for recording~     vestibular-evoked myogenic potentials (VEMPs), we evaluated whether a simultaneous recording~     of ocular and cervical VEMPs after unilateral or bilateral stimulation can be achieved~     without a loss in diagnostic sensitivity.~   "
39499|NCT03049670|"~     Klorsept is a debridement solution of necrotic infected tissue promoting wound healing. The~     aim of this study is to elaborate the effectiveness and safety of this solution.~   "
39500|NCT03049657|"~     Clinical trial with an European Community marked medical device in patients with ischemic~     heart disease and clinical indication of coronary revascularization with drug-eluting stent.~      Clinical follow-up will be done according to this way: first month telephone or face-to-face~     interview and at 6 ± 1 month an Angiography follow up + OCT (optical coherence tomography)~      A randomized clinical trial to compare the efficacy of Angiolite Stent versus a~     second-generation drug-eluting stent such as Xience stent.(non-inferiority design)~   "
39501|NCT03049644|"~     Mechanical diagnosis and treatment (MDT) and Manual Therapy (MT) have both demonstrated~     efficacy in the management of CLBP. The use of a Point of Care (POC) design in this study~     will allow for comparison of these two treatment modalities in a clinical setting. The~     purpose of this study is to demonstrate the feasibility of recruiting, enrolling and~     collecting outcome data on CLBP patients utilizing the POC methodology.~   "
39502|NCT03049631|"~     The primary objective aims are to assess the effects of regular consumption of red~     raspberries (RRB) with and without fructooligosaccharide (FOS) on the composition of the gut~     microbiota after 4 week intake and in parallel characterize plasma and urine metabolite~     profiles examining qualitative and quantitative intervention associated changes.~   "
41849|NCT03018938|"~     The purpose of this study is to compare the effectiveness of basal insulin analog and insulin~     analog mid mixture in Chinese participants with type 2 diabetes mellitus.~   "
39503|NCT03049618|"~     This phase IIa trial studies how well recombinant EphB4-HSA fusion protein and pembrolizumab~     work in treating patients with non-small cell lung cancer that has spread to other places in~     the body or head and neck squamous cell cancer that has come back or spread to other places~     in the body. Recombinant EphB4-HSA fusion protein may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as~     pembrolizumab, may interfere with the ability of cancer cells to grow and spread. Giving~     recombinant EphB4-HSA fusion protein and pembrolizumab may work better in treating patients~     with non-small cell lung or head and neck squamous cell cancer.~   "
39504|NCT03049605|"~     This study are to:~        -  Evaluate effect of magnetic therapy on peripheral neuropathy in diabetic patients.~        -  Evaluate effect of laser therapy on peripheral neuropathy in diabetic patients.~        -  Compare effects of magnetic therapy with that of laser therapy on peripheral neuropathy~          in diabetic patients.~   "
39505|NCT03049592|"~     High-risk obstetrical patient Intervention to promote Birth Interval Spacing utilizing the~     Contraceptive CHOICE project script to reduce Unintended Subsequent pregnancies (HIBISCUS) is~     a collaborative study utilizing qualitative methods to assess the acceptability including a~     family planning specialist's postpartum contraception counseling during and after prenatal~     care among Latina obstetric women with pre-gestational diabetes. The investigators will~     compare the effectiveness of HIBISCUS versus usual contraceptive counseling on Long-Acting~     Reversible Contraception (LARC) use at 3 months postpartum.~   "
39506|NCT03049579|"~     The purpose of this study is to investigate the effects of a probiotic supplementation on~     adult volunteers with having caught the common cold more than 4 times in the past year. This~     study is a single center, double-blind, randomized, controlled, parallel-designed,~     prospective trial. Subjects received a probiotic drink containing probiotics of Lactobacillus~     paracasei (108 colony forming units (CFU)/ml), Lactobacilluscasei431® (108CFU/ml) and~     Lactobacillus fermentiumPCC® (106CFU/ml) or an identical placebo without probiotics for a~     12-week study period.~      The incidence of flue and cold during the study period were compared between study groups.~      Blood and fecal samples were collected at baseline and at the end of the intervention. Fecal~     samples were collected for the secretory immunoglobulin A (sIgA) analysis. Blood sample was~     drawn for interferon γ (IFN-γ), interleukin 4 (IL-4), interleukin 10 (IL-10), immunoglobulin~     A (IgA), immunoglobulin G (IgG) and immunoglobulin M (IgM) analysis.~   "
39507|NCT03049566|"~     This study aims to assess independent factors associated with the clinical decision to~     discontinue ASA preoperatively in patients undergoing elective non-cardiac surgery.~   "
39508|NCT03049553|"~     In Denmark, the first birth cohorts of women offered HPV-vaccination as girls are entering~     the cervical screening program. These women are expected to be better protected against~     cervical cancer. It has not yet been decided how to screen these women.~      This method study will investigate a possible screening scheme that could provide a reduced~     burden of screening for HPV-vaccinated birth cohorts.~   "
39509|NCT03049540|"~     This study assesses in a double-blind, randomized, placebo-controlled multi-center pilot~     trial the effect of PDE-5 inhibition with Tadalafil on right ventricle size and function,~     exercise capacity and neurohumoral activation in adults with congenital heart disease and a~     right ventricle in subaortic position over a 3-year follow-up period.~   "
39510|NCT03049527|"~     The objective of this research project is to investigate specific behaviors and exposures~     related to sugarcane work and their association with non-communicable diseases, specifically~     Chronic Kidney Disease of Unknown Origin (CKDu) among sugarcane workers in Guatemala. Over~     the course of the 6-month sugarcane harvest the investigators will assess risk factors for~     declining kidney function, and also changes in biomarkers of kidney function pre and post~     work shift of field and factory workers and their possible relationships with dehydration and~     heat stress. The investigators will also evaluate the effectiveness of an intervention aimed~     at increasing hydration and reducing heat stress. Finally the investigators will measure~     biomarkers of exposure and environmental samples for heavy metals, agrochemicals, and~     infectious disease (Leptospira).~   "
39511|NCT03049514|"~     Central retinal artery occlusions (CRAO) are the equivalent of an ischemic stroke (IS) at the~     retinal level. They share the same risk factors and common pathology. Their incidence is~     lower (8.5 / 100,000) and the functional prognosis is unfavorable in 80% of cases with visual~     acuity (VA) <1/10. The diagnosis of an CRAO is clinically based on the sudden occurrence of a~     decrease in deep visual acuity with fundamentally signs of reactive ischemia. There is no~     data on early retinal arterial recanalization after CRAO, nor on the relationship between~     early recanalization (spontaneous or post-thrombolysis) and visual prognosis.~   "
39512|NCT03049501|"~     The prevalence of family caregivers is projected to increase in concert with the projected~     increase in number of AD patients. The focus of the study is to gather systematic data on the~     acceptability and efficacy of a unique technology-based, culturally- tailored psycho-social~     intervention program that targets ethnically/culturally diverse family caregivers of patients~     with Alzheimer's Disease. The overall goal of the project is to improve the lives of family~     caregivers as well as their ability to provide care to their loved one and to reduce~     disparities in access to needed services and support among caregiver populations.~   "
39513|NCT03049488|"~     Background:~      RSV is a virus that infects the lungs and breathing passages. Healthy adults who are infected~     generally have mild cold symptoms for a week or two. But it can also be serious, especially~     for infants and older adults. It can be spread by direct or indirect contact with respiratory~     secretions. Researchers want to study a new vaccine to prevent RSV.~      Objective:~      To see if a vaccine for RSV is safe and if it causes side effects.~      Eligibility:~      Healthy adults 18-50 years old~      Design:~      Participants will be screened in a different protocol.~      Participants will have 13 visits over 1 year.~      Some participants will receive just vaccine. Some will receive vaccine mixed with alum, which~     could make the body respond to the vaccine better.~      All will receive their dose by injection in the upper arm. They will receive two doses, one~     at the beginning of the study and another 12 weeks later.~      Participants will be watched for 1 hour after injection. They will be called 1 day after.~      They will keep track of their temperature and side effects for 7 days after.~      Participants will receive a ruler to measure any changes on their skin at the injection site.~      At all visits, participants will be checked for health changes or problems. They may have~     blood drawn.~      At some visits, participants will have samples taken from their nose and mouth.~   "
39514|NCT03049475|"~     Background:~      Sickle Cell Disease (SCD) is a blood disorder that occurs mainly in people of African~     descent. Researchers want to learn more about the painful attacks and complications~     associated with SCD. They want to look for a relationship between SCD and specific changes in~     the blood. They want to study the role of genetics, inflammation, and blood clotting factors~     in SCD. They will do this with blood samples collected during an acute painful attack and in~     between attacks.~      Objective:~      To learn more about the painful attacks and complications associated with SCD.~      Eligibility:~      People ages 18-80 with SCD or who are healthy Africans or African Americans without SCD~      Design:~        -  Participants will be screened with medical history and physical exam.~        -  Healthy participants will have one visit.~        -  Participants with SCD will have their first visit when they are not having a pain~          attack. They will have their next visit during a pain attack. About 3-4 months after~          this attack, they will have a final visit.~        -  Visits will include a physical exam, and blood and urine tests.~        -  Participants may have their blood samples used for genetic testing for research.~   "
39515|NCT03049462|"~     Background:~      Brown adipose tissue (BAT) is a type of fat in the body. It may prevent weight gain, improve~     insulin sensitivity, and reduce fatty liver. Researchers want to see if BAT helps the body~     burn energy.~      Objective:~      To learn more about how BAT works to burn energy.~      Eligibility:~      Healthy people ages 18-40 with a body mass index between 18 and 40~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Blood, urine, and heart tests~      Dietitian interview~      Participants will have an overnight baseline visit. This includes:~      Repeats of screening tests~      Exercise test~      Scans. For one scan, a radioactive substance is injected into the arm.~      FSIVGIT: An IV is inserted into veins in the right and left arms. Glucose and insulin are~     injected in one arm. Blood glucose and insulin levels are measured from the other.~      Metabolic suite: Participants stay 18 19 hours in a room that measures their metabolic rate.~     Monitors on the body measure heart rate, movement, and temperature.~      Optional fat biopsy: A small piece of tissue is removed with a needle.~      Participants will take 2-4 pills daily for 4 weeks. All women will take the drug mirabegron.~     Men will be randomly get either the drug or a placebo.~      All participants will have a visit after 2 weeks of the pills. They will repeat the screening~     tests.~      Participants will have an overnight visit 2 weeks later. They will repeat the baseline tests.~      Participants will keep food and medication diaries.~      Participants will have a follow-up visit 2 weeks after stopping the pills. This includes~     heart tests.~   "
39516|NCT03049449|"~     Background:~        -  Improved treatments for a variety of treatment-resistant, CD30-expressing malignancies~          including Hodgkin lymphoma, anaplastic large cell lymphoma, and other CD30- expressing~          lymphomas are needed.~        -  T cells can be genetically modified to express chimeric antigen receptors (CARs) that~          specifically target malignancy-associated antigens.~        -  Autologous T cells genetically modified to express CARs targeting the B-cell antigen~          CD19 have caused complete remissions in a small number of patients with lymphoma. These~          results demonstrate that CAR-expressing T cells can have anti-lymphoma activity in~          humans.~        -  CD30 expression can be easily detected by immunohistochemistry on lymphoma cells, which~          allows selection of CD30-expressing malignancies for treatment.~        -  CD30 is not known to be expressed by normal cells except for a small number of activated~          lymphocytes.~        -  We have constructed a novel fully-human anti-CD30 CAR that can specifically recognize~          CD30-expressing target cells in vitro and eradicate CD30-expressing tumors in mice.~        -  This particular CAR has not been tested before in humans.~        -  Possible toxicities include cytokine-associated toxicities such as fever, hypotension,~          and neurological toxicities. Elimination of a small number of normal activated~          lymphocytes is possible, and unknown toxicities are also possible.~      Objectives:~      Primary~      -Determine the safety and feasibility of administering T-cells expressing a novel fullyhuman~     anti-CD30 CAR to patients with advanced CD30-expresssing lymphomas.~      Eligibility:~        -  Patients must have Hodgkin lymphoma, anaplastic large cell lymphoma, peripheral T-cell~          lymphoma not otherwise specified, diffuse large B-cell lymphoma not otherwise specified,~          primary mediastinal B-cell lymphoma, grey zone lymphoma, enteropathyassociated T-cell~          lymphoma, or extranodal NK/T-cell lymphoma, nasal type~        -  Patients must have malignancy that is both measurable on a CT scan with a largest~          diameter of at least 1.5 cm and possessing increased metabolic activity detectable by~          PET scan. Alternatively patients with lymphoma detected by flow cytometry of bone marrow~      are eligible.~        -  Patients must have a creatinine of 1.4 mg/dL or less and a normal cardiac ejection~          fraction.~        -  An ECOG performance status of 0-1 is required.~        -  No active infections are allowed including any history of HIV, hepatitis B, or hepatitis~          C. At the time of protocol enrollment patients must be seronegative for CMV by antibody~          testing or must have a negative blood CMV PCR.~        -  Absolute neutrophil count greater than or equal to 1000/micro L, platelet count greater~          than or equal to 45,000/micro L, hemoglobin greater than or equal to 8g/dL~        -  Serum ALT and AST less or equal to 3 times the upper limit of the institutional normal~          unless liver involvement by malignancy is demonstrated.~        -  At least 14 days must elapse between the time of any prior systemic treatment (including~          corticosteroids) and initiation of protocol enrollment.~        -  Clear CD30 expression must be detected on 75% or more of malignant cells from either~          bone marrow or lymphoma mass by flow cytometry or immunohistochemistry. The patient s~          malignancy will need to be assessed for CD30 expression by flow cytometry or~          immunohistochemistry performed at the NIH. If unstained, paraffin-embedded bone marrow~          or lymphoma sections are available from prior biopsies, these can be used to determine~          CD30 expression by immunohistochemistry; otherwise, patients will need to come to the~          NIH for a biopsy to determine CD30 expression. The sample for CD30 expression can come~          from a biopsy obtained at any time before enrollment, unless the patient has received a~          prior anti-CD30 monoclonal antibody, in which case the sample must come from a biopsy~          following completion of the most recent anti-CD30 monoclonal antibody treatment.~        -  Eligible patients with Hodgkin lymphoma must fulfill one of the following criteria: 1)~          have received two prior therapies, one of which must be an autologous stem cell~          transplant, or 2) have received three prior lines of therapy. Eligible patients with any~          of the listed peripheral T cell lymphomas or non-Hodgkin lymphomas must have received~          two lines of prior therapy, at least one of which must contain cytotoxic~      chemotherapyPatients with diffuse large B-cell lymphoma or primary mediastinal B-cell~     lymphoma must have received 2 prior treatment regimens at least 1 of which included an~     anthracycline and an anti-CD20 monoclonal antibody.~        -  Patients who have never had an allogeneic hematopoietic stem cell transplant as well as~          patients who have had an HLA-matched sibling or a 8/8 HLA-matched unrelated donor or~          8/8-matched related (not HLA-identical) hematopoietic stem cell transplant are~          potentially eligible.~        -  Women who are pregnant or plan to become pregnant will be excluded.~      Design...~   "
39517|NCT03049436|"~     Physical activity has demonstrated efficacy in cancer prevention and improves quality of life~     and outcome in cancer survivors. Patients undergoing chemotherapy, especially those with~     advanced disease, may have symptoms leading to inactivity. Adapted physical activity (APA)~     among those patients could improve their tolerance to the treatment, and thereby their~     quality of life. APA could be beneficial to patients with curable disease as well as patients~     undergoing palliative chemotherapy. Some studies suggest that fighting against loss of muscle~     mass could lead to a survival benefit. However, APA is not established in daily practice and~     has not yet been evaluated in a chemotherapy ambulatory care unit.~      Primary aim of the study is to assess feasibility of an APA program in a chemotherapy~     ambulatory care unit of digestive, lung, hematological and dermatological cancers Secondary~     aim is to measure the impact of an APA program on fatigue, anxiety, depression and handgrip~     strength in patients beginning chemotherapy or targeted therapy for a digestive, lung,~     hematological or dermatological cancer, of any stage.~   "
39518|NCT03049423|"~     To compare the results of multi-position MRI scans for ankle ligaments and tendons to clarify~     how to obtain imaging data of different ankle ligaments and define severity of injuries to~     calculate the rate of correct diagnosis, thereby developing a reasonable surgical treatment~     in clinical practice.~   "
39519|NCT03049410|"~     This is a prospective multicentre randomised controlled trial comparing the outcomes from~     Intracorporeal RARC (iRARC) with open radical cystectomy (ORC) in patients with bladder~     cancer. The study will recruit patients with non-muscle invasive bladder cancer (NMIBC) or~     muscle invasive bladder cancer (MIBC) who have selected radical cystectomy for the treatment~     of bladder cancer. The time of interest for measurement of the primary outcomes will be 90~     days post-surgery.~      Eligible patients will include those receiving neo-adjuvant chemotherapy (typically~     gemcitabine and cisplatin) and those having either an ileal conduit or a neo-bladder~     reconstruction.~      Patients who have selected radical cystectomy after appropriate counselling and following a~     specialist multi-disciplinary team (SMDT) recommendation, will be approached and asked to~     consent for this study.~      Consenting participants will be randomised 1:1 to either iRARC or ORC. Patients will be~     followed for a minimum of 90 days post-surgery.~      The study will be conducted in NHS Trusts designated as Cancer Centres. Patients will be~     stratified by~        -  Type of urinary diversion (Continent diversion or ileal conduit)~        -  Performance status~        -  Centre Trial assessments will be conducted at baseline (before surgery), whilst~          participants are on admission and then 5, 12, 24 weeks and 1 year post surgery.~   "
39520|NCT03049397|"~     This pilot clinical trial studies how well the Enhancing Connections program improves family~     adjustment in patients with incurable cancer. Participating in an educational program with a~     co-parent to learn about ways to talk to a child about cancer may help parents and co-parents~     support their child with the parent's cancer and may help families communicate and function~     better.~   "
39521|NCT03049384|"~     Cancer-related fatigue (CRF) is a common and distressing symptom of cancer and/or cancer~     treatment that can persist for months or years in cancer survivors. Exercise is beneficial~     for the management of CRF, and general exercise guidelines for cancer survivors are~     available. However, exercise interventions have not been tailored to alleviate CRF in~     fatigued cancer survivors, and thus the potential to alleviate CRF may not have been~     realized. The primary aim of this research is to investigate the effect of a traditional vs.~     tailored 12-week exercise intervention on self-reported CRF severity.~   "
39722|NCT03046758|"~     The objective of this trial is to evaluate the safety of the intraperitoneal administration~     of the combination of fosfomycin, metronidazole, and granulocyte-macrophage~     colony-stimulating factor (GM-CSF) in patients undergoing surgery for uncomplicated~     appendicitis. Further, in a sub-trial the aim is to investigate the plasma concentrations of~     fosfomycin and metronidazole after intraperitoneal administration.~   "
39522|NCT03049371|"~     The current study will explore behavioral, surgical and biological neovaginal and rectal HIV~     transmission risks and feasibility of collection of blood and ano-genital samples (rectal,~     genital and neo-vaginal, including urine) for microbiological, immunological and cytological~     characterization in the context of antiretroviral chemoprophylaxis for the prevention of HIV~     infection in TGW. This includes the feasibility of home self-collection of ano-genital~     samples prior to habitual cleansing of the anatomical collection site.~   "
39523|NCT03049358|"~     This randomized phase I trial studies how well olfactory training works in improving sense of~     smell after radiation therapy in patients with paranasal sinus or nasopharyngeal cancer.~     Olfactory training may improve smell function after radiation therapy in patients with~     paranasal sinus or nasopharyngeal cancer.~   "
39524|NCT03049345|"~     Gastric cancer has an incidence in North America of over 24,000 new cases annually, of which~     approximately 15% are diagnosed at an early stage. Standard of care for early gastric cancer~     (EGC) treatment has historically included anatomical resection with regional lymphadenectomy.~     However, with the recent emergence of organ-sparing techniques, select patients with a very~     low risk of lymph node metastases are able to avoid anatomical resection and its inherent~     short and long term consequences. Despite this advance, EGC patients with high risk features~     continue to require anatomical resection to achieve adequate lymph node staging, despite the~     fact that 75-95% of these patients ultimately are found to have node negative disease. Due to~     the inadequacy of standard imaging modalities to reliably detect nodal metastases in EGC~     patients, sentinel lymph node sampling for gastric cancer was developed using principals~     similar to those used broadly for breast and melanoma patients. Early reports from Asia~     suggest this technique has very high success rates, accuracy and sensitivity, however it has~     never been verified in a North American context. This study aims to test SLN sampling for~     North American gastric cancer patients at a high volume regional treatment centre, with an~     aim to expand the application of organ sparing resection to EGC patients.~      This project aims to determine the sensitivity and accuracy of sentinel lymph node sampling~     for early gastric cancer patients at a high volume, North American, tertiary care centre.~   "
39525|NCT03049332|"~     This project is to develop a culturally sensitive and feasible self- and family-management~     intervention that will assist HIV+ Chinese women and their families to manage the illness and~     improve quality of life and clinical outcomes.~   "
39526|NCT03049319|"~     Psoriasis affects 2-3% of the American population. While a wide variety of therapies~     currently exist, including topical corticosteroids and Vit D analogs, oral immunosuppressant~     and retinoid agents a better understanding of phototherapy is needed. Given the prevalence of~     localized psoriasis and dissatisfaction with treatment, investigation of localized treatment~     should be a priority for researchers with goals to improve the current standard of care.~   "
39527|NCT03049306|"~     The primary objective in this study is to test whether propranolol lowers glucose and free~     fatty acid levels during sleep in obstructive sleep apnea (OSA), and preserves vascular~     function (EndoPAT) versus placebo. The secondary objective is to test whether propranolol~     influences sleep quality, architecture, and hemodynamics in OSA. OSA will be elicited by~     temporarily discontinuing CPAP therapy in patients with a history OSA accustomed to CPAP~     therapy (CPAP withdrawal).~   "
39528|NCT03049293|"~     To determine the impact of Midazolam levels in follicular fluid on morpho-kinetics and~     morpho-genetics.~      The reason to measure Midazolam levels in larger size follicles in this study is to maximize~     the chances to get a mature oocyte and therefore develop into a potential embryo to be~     analyzed.~   "
39529|NCT03049267|"~     Study design: A double-blind randomised placebo-controlled trial~      Intervention: Randomized placebo controlled treatment of 20 HS patients of which fifteen~     patients will be randomized to apremilast and five patients to placebo. The total duration of~     the treatment period per subject is 16 weeks.~      Primary objectives: To evaluate the expression profile of inflammatory cytokines in HS~     lesional skin at week four (t=4) and week sixteen (t=16):~        -  of patients receiving apremilast compared to placebo;~        -  within both groups relative to baseline (t=0).~      Secondary objectives:~        -  To prospectively evaluate the clinical efficacy of apremilast.~        -  To assess the effect of apremilast on patient reported outcomes measures.~        -  To assess the short-term safety and tolerability of apremilast in patients with~          hidradenitis suppurativa.~   "
39530|NCT03049254|"~     Arrhythmogenic ventricular cardiomyopathy (AVC) is a genetic condition which affects the~     heart and can lead to heart failure and rhythm problems, of which, sudden cardiac arrest or~     death is the most tragic and dangerous. Diagnosis and screening of blood-relatives is very~     difficult as the disease process can be subtle, but sufficient enough, so that the first~     event is sudden death.~      The Mayo Clinic AVC Registry is a collaboration between Mayo Clinic, Rochester, USA and~     Papworth Hospital, Cambridge University Hospitals, Cambridge, UK. The investigators aim to~     enroll patients with a history of AVC or sudden cardiac death which may be due to AVC, from~     the US and UK. Family members who are blood-relatives will also be invited, including those~     who do not have the condition. Data collected include symptoms, ECG, echocardiographic, MRI,~     Holter, loop recorder, biopsies, exercise stress testing, blood, buccal and saliva samples.~      Objectives of the study:~        1. Discover new genes or altered genes (variants) which cause AVC~        2. Identify biomarkers which predict (2a) disease onset, (2b) disease progression, (2c) and~          the likelihood of arrhythmia (ventricular, supra-ventricular and atrial fibrillation)~        3. Correlate genotype with phenotype in confirmed cases of AVC followed longitudinally~          using clinical, electrocardiographic and imaging data.~        4. Characterize desmosomal changes in buccal mucosal cells with genotype and validate with~          gold-standard endomyocardial biopsies~   "
39551|NCT03048981|"~     Many patients undergoing surgery use naturopathic drugs, including fish oil. Fish oil has~     been reported to increase bleeding in patients through inhibiting platelet aggregation and~     prolonging of clot formation time. The Swedish Medical Products Agency recommends that~     patients stop taking the naturopathic medicines including fish oil two weeks prior planed~     surgery. The aim of this study is to examine the effects of fish oil given to healthy~     volunteers using point of care coagulation assessment and flow dependent Cellix instrument~     before and after intake of fish oil.~   "
39531|NCT03049241|"~     Potential factors involved in neuromuscular fatigue were classified into two categories: 1)~     central factors involving the central nervous system and neural pathways, and 2) peripheral~     factors occurring within the muscle beyond the neuromuscular junction. In adults, it has been~     shown that peripheral factors contribute to a large part of the fatigue induced by repeated~     maximal contractions. However in children, central factors could account for the development~     of fatigue to a greater extent. Force-generating capacity and musculotendinous stiffness~     could be two of the discriminatory factors accounting for the differences in the~     neuromuscular fatigue between children and adults.~      Force production capacity and musculotendinous stiffness vary as function of muscle length.~     Naturally, they could differ depending on the muscle groups studied. The main aim of the~     present protocol is to compare the effect of knee extensors and ankle plantarflexors length~     on the development and aetiology of neuromuscular fatigue, in children and adults. The~     investigators formulated the hypotheses that at short muscle length force and low~     musculotendinous stiffness, differences in force between children and adults would be~     reduced. Thus neuromuscular fatigue development and aetiology would be similar between both~     groups. The results of the present protocol will allow to better understanding of the~     aetiology of neuromuscular fatigue in children and help improving training or rehabilitation~     programs.~   "
39532|NCT03049228|"~     It has been suggested that mitochondrial dysfunction might play a role in the development of~     diabetic cardiomyopathy. From animal studies, it has been suggested that an altered PPAR and~     PGC1 expression is involved in the reduced cardiac mitochondrial function, however human data~     on cardiac mitochondrial function and PPAR regulation is scarce. The latter is due to the~     fact that there is no validated measurement for assessing cardiac mitochondrial function~     non-invasively in vivo. It has been suggested that measuring PCr/ATP ratio with 31P-MRS in~     the heart reflects cardiac mitochondrial function. However, so far no direct validation of~     this method has been performed. The aim of this study will be to validate in vivo 31P-MRS~     with ex vivo measurements of mitochondrial function. To this end, the hypothesis is that in~     vivo 31P-MRS is a valid method for measuring cardiac mitochondrial function when compared~     with ex vivo mitochondrial respirometry.~   "
39533|NCT03049215|"~     The study hypothesis is that placement of LAMS plus an overlapping double pigtail stent for~     endoscopic transmural drainage of PFCs with solid debris will result in improved drainage and~     require fewer endoscopic interventions compared to placement of LAMS alone.~   "
39534|NCT03049202|"~     Obstructive lung disease is an increasing global health problem of pandemic proportions, with~     COPD alone affecting >10% of the population. Smoking is the main and most well studies risk~     factor for developing COPD. However, chronic airway obstruction also in never-smoking~     populations has recently been recognized as an increasing health problem.~      In the clinical segment (PI: Prof. C. Magnus Skold), 1000 subjects from the Swedish national~     SCAPIS study will be clinically well characterized in one of the six Swedish University~     Hospital Respiratory clinics (clinical site PIs: Anders Andersson, Leif Bjermer, Anders~     Blomberg, Christer Janson, Lennart Persson, Magnus Skold). This first screening includes all~     never-smokers with COPD identified in the SCAPIS study. A subset of 300 subjects from the~     groups of Healthy never-smokers, current-smokers with normal lung function, current-smokers~     with COPD, ex-smokers with COPD, and never-smokers with COPD will be selected for the~     Bronchoscopy segment, were sampling will be performed from a number of anatomical locations,~     including bronchial biopsies, airway epithelial brushings, and bronchoalveolar lavage. Serum,~     plasma, and urine samples will also be collected.~      In the systems medicine segment (PI: Assoc. prof Asa M. Wheelock), alterations at the~     epigenetic, mRNA, microRNA, proteome, metabolome and microbiome level will be performed from~     multiple lung compartments (airway epithelium, alveolar macrophages, exosomes, and~     bronchoalveolar exudates). By means of biostatistics and bioinformatics approaches, specific~     mediators and molecular pathways critical in the pathological mechanisms of obstructive lung~     disease related to never-smoker disease phenotypes will be identified.~      In the immunohistochemistry segment (PI: Prof. Jonas Erjefalt), a number of molecules of~     relevance for disease pathology will be investigated in bronchial biopsies collected from the~     300 subjects in the Bronchoscopy segment.~   "
39535|NCT03049189|"~     The purpose of the study is to evaluate efficacy and safety of Peptide Receptor Radionuclide~     Therapy (PRRT) with 177Lu-Edotreotide compared to targeted molecular therapy with Everolimus~     in patients with inoperable, progressive, somatostatin receptor-positive (SSTR+),~     neuroendocrine tumours of gastroenteric or pancreatic origin (GEP-NET).~   "
39536|NCT03049176|"~     This is a prospective, non-randomized, open-label study to look at the uptake, adherence to,~     and impact of pre-exposure prophylaxis (PrEP), antiretroviral therapy (ART), semen washing,~     and vaginal insemination to prevent HIV among HIV-discordant couples attempting conception in~     Zimbabwe.~   "
39537|NCT03049163|"~     Routine anesthesia methods for vitrectomy surgery include retrobulbar and peribulbar~     anesthesia. However, both methods have potential complications that can vary from minor to~     severe.~      Vitrectomy surgery for vitreous floaters is widely considered straighter forward than other~     vitreoretinal surgeries.~      Hence, the investigators compared the effect of topical anesthesia (with eye drops) and~     retrobulbar anesthesia for 27-gauge par plana vitrectomy for symptomatic vitreous floaters.~   "
39538|NCT03049150|"~     To determine whether MALDI, a type of Mass-Spectometry, can use protein pattern detection~     within urine to predict postoperative (after an operation) kidney damage in adults who have~     undergone emergency hip fracture surgery?~   "
39539|NCT03049137|"~     Using bone ring grafts with simultaneous implant placement after three-dimensional~     augmentation of severely defective bone ridges using computer-guided surgical templates. The~     study compares accuracy effectiveness by mimics software~   "
39552|NCT03048968|"~     The purpose of this study was to investigate the effects of the new wearable hip assist~     robot, gait enhancing mechatronic system (GEMS) developed by Samsung Advanced Institute of~     Technology (Samsung Electronics Co, Ltd., Korea) on gait, sit-to-stand movement and brain~     activity in elderly adults and stroke patients.~   "
39553|NCT03048955|"~     PURPOSE: The primary purpose of this study is to demonstrate that the Composite Clinical~     Success of the study group receiving the Superion® IDS is not inferior to the success rate~     observed in the study group treated by direct decompression at 60 months follow-up.~     Secondarily, the trial is intended to establish that Composite Clinical Success of the study~     group receiving the Superion® IDS at 24 months is not inferior to the success rate observed~     at 24 months in patients treated with the Superion® IDS in the original IDE trial. Thirdly,~     the trial is intended to establish that Composite Clinical Success of the population~     receiving the Superion® IDS in this trial at 24 months is not inferior to the success rate~     observed at 24 months in patients treated with direct decompression.~   "
39749|NCT03046407|"~     This project intends to transplant human embryonic stem cells derived retinal pigment~     epitheliums into subretinal space of patients to treat dry age-related macular~     degeneration(dry-AMD).And we will assess the safety and efficacy of RPE transplants to treat~     dry AMD.~   "
39540|NCT03049124|"~     Currently, there is no clear indication if exercise is safe and if it confers health benefits~     for adults undergoing preoperative neoadjuvant chemoradiation for rectal cancer - a~     population who may have limited exercise tolerance and who may be at an increased risk for~     adverse events associated with exercise. In this prospective single-arm feasibility trial, we~     aim to examine the safety and feasibility of a 12-week exercise intervention for adults~     undergoing preoperative neoadjuvant chemoradiation for rectal cancer to inform the~     development of a large-scale randomized controlled trial that will assess the efficacy of~     exercise administered during preoperative neoadjuvant chemoradiation for rectal cancer.~     Adults diagnosed with rectal cancer and scheduled for preoperative neoadjuvant chemoradiation~     will be recruited over a 12-month period into a supervised exercise intervention consisting~     of aerobic and strength training to be done 3 times per week. Feasibility, safety,~     patient-reported outcomes, and physical tests will be performed pre-intervention and~     post-intervention. This study will provide data on the feasibility of an exercise~     intervention and will help determine if it is safe to progress with a large-scale randomized~     controlled trial to test the benefits of exercise for adults undergoing preoperative~     neoadjuvant chemoradiation for rectal cancer. It will also provide initial estimates of the~     parameters for patient-reported outcomes, which are required to calculate the sample size for~     the large-scale randomized controlled trial to ensure it is sufficiently powered.~   "
39541|NCT03049111|"~     This study is designed to identify Dermatophagoides farinae, or Der f, sensitive asthmatics~     who demonstrate a late phase asthmatic response after Der f inhalation. These subjects may be~     invited to participate in a planned future study investigating novel asthma treatments.~   "
39542|NCT03049098|"~     The aim of this observational study is to compare the visual interests between residents in~     high-fidelity simulation practice~   "
39543|NCT03049085|"~     Effect of Preoperative Aspirin in patients undergoing Off-pump Coronary Artery Bypass~     Grafting. A double-blind, placebo-controlled, randomized trial.~   "
39544|NCT03049072|"~     The purpose of the study is the prospective and standardized data collection of patients~     treated with ion therapy at MedAustron.~   "
39545|NCT03049059|"~     A Comparative study for Efficacy and Safety Between 4% hydroquinone cream with or without~     Fractional Picosecond 1,064 nm Laser for the Treatment of Dermal or Mixed Type Melasma~   "
39546|NCT03049046|"~     Approximately 21 subjects with amyotrophic lateral sclerosis (ALS) will be randomized (6 to~     1) to receive by mouth seven morning doses of CC100 or placebo for 7 days. Subjects are~     required to stay in the Clinic for approximately 9 hours following the first and last dose.~     Subjects will also have a mid-week clinic visit and will be contacted by phone within 3 to 5~     days after the last dose.~      Funding Source - FDA OOPD~   "
39547|NCT03049033|"~     Parkinson's Disease (PD) is defined by characteristic motor symptoms including slow~     movements, small movements, difficulty with movement initiation and disruptions in timing.~     Besides gross motor symptoms, fine motor impairments in PD cause difficulties with everyday~     tasks such as writing, self-care, and fine object manipulation. These activity limitations~     can lead to disability, social isolation, and a reduced quality of life. In a series of~     breakthrough studies Michael Thaut and colleagues developed Neurologic Music Therapy (NMT)~     and found it can address many gross motor impairments and improve gait and balance. The~     underlying idea is that rhythm is the essential component relating music specifically to~     motor behavior. The mechanism of action is called rhythmic entrainment where one system's~     motion or signal frequency entrains the frequency of another system. The effect of NMT on~     fine motor function has not been investigated yet. Music activities are important in the~     lives of many older adults. Notably, the use of music has been associated with increased~     well-being for older adults, as it fosters social connection and mood regulation.~     Furthermore, many musical activities have limited physical demands, making them attainable~     for individuals who are living with mobility impairments or other physical restrictions.~     Based on the literature and the investigators preliminary studies, the investigators propose~     to test the efficacy of Neurologic Music Therapy in comparison to Occupational Therapy (OT)~     as standards of care on adults in the Parkinson's spectrum. The investigators have defined a~     working plan using different musical instruments and growing tempo to specifically improve~     fine motor movements.~   "
39548|NCT03049020|"~     Based on a prospective study, to evaluate how pre-operative pelvic floor status - the~     presence of injury to the musculus levator ani - may influence the results of laparoscopic~     sacrocolpopexy. The investigators hope to confirm or disprove the hypothesis that the~     presence of such injury increases the risk of post-operative prolapse recurrence~   "
39549|NCT03049007|"~     Psychological distress is a natural reaction following the death of a loved one.~     Nevertheless, research has shown that for a significant minority of bereaved individuals the~     grieving process is complicated. Instead of decreasing, these individuals experience an~     intense grief reaction that becomes abnormally persistent and increasingly debilitating~     across time. It has been suggested that this intense, persistent grief reaction meets~     criteria to be considered a distinct mental disorder. Prolonged grief disorder (PGD) has been~     proposed to capture this condition and is expected to be included in the forthcoming ICD-11.~     The proposed project aims to prepare healthcare services to use the diagnosis of prolonged~     grief disorder (PGD) by determining the frequency of PDG in a population sample of bereaved~     spouses and their adult children. It will also identify early predictors of PGD and common~     trajectories of natural and prolonged grief. The mapping of grief trajectories may turn out~     to be a potential prognostic tool to identify individuals with high versus low risk of~     developing PGD.~   "
39550|NCT03048994|"~     Severe sepsis is a common condition with high mortality and morbidity. A previous~     meta-analysis has demonstrated the safety of glutamine supplementation with suggestion of~     mortality and morbidity benefits in critically ill patients. But there is lack of evidence to~     recommend the use of intravenous glutamine supplementation in this population group. A~     randomized controlled trial which is adequately powered will resolve this issue and can be~     included in future international nutrition guidelines for the critically ill. This pilot~     study is done prior to a proposed local multi-center study to investigate the effects of~     glutamine supplementation.~   "
39785|NCT03045939|"~     This study will evaluate the insertion of double balloon device (DBD) for cervical ripening~     for 12 h vs 6 hours.~   "
39555|NCT03048929|"~     The overall goals of this study are to examine the relationship between chronic inflammation~     and threat and reward sensitivity, and to determine the effects of acute inflammation on~     threat sensitivity, in individuals with and without moderate to severe PTSD symptoms. The~     investigators will first conduct an observational study to examine the relationship between~     chronic inflammation and neural and behavioral measures of threat sensitivity. Then, the~     investigators will conduct a randomized, double-blind, placebo-controlled, between-subjects~     study to examine the effects of acute inflammation on neural and behavioral measures of~     threat sensitivity.~   "
39556|NCT03048916|"~     Dysphagia after stroke is associated to increased pulmonary complications and mortality. The~     swallowing therapies could decrease the pulmonary complications and improve the quality of~     life after stroke. The swallowing therapies include dietary modifications, thermal~     stimulation, compensatory positions, and oropharyngeal muscle stimulation. Most researchers~     used clinical assessments and videofluoroscopy to evaluate the effect of the swallowing~     therapies. Some authors performed functional magnetic resonance imaging (fMRI) to investigate~     the brain neuroactivity during swallowing with tasks in normal adults and unilateral~     hemispheric stroke patients. The aim of this study is to explore the effect of swallowing~     therapies not only in clinical swallowing function but also brain plasticity of acute stroke~     patients with dysphagia by videofluoroscopy and fMRI.~   "
39557|NCT03048903|"~     Random grouping by computer, divided into two groups, a group of rhubarb treatment group,~     another group for the placebo group.~   "
39558|NCT03048890|"~     VascTrac is a mobile medical application that tracks users' physical activity levels in order~     to predict endovascular failure of patients with Peripheral Artery Disease.~   "
39559|NCT03048877|"~     Radioactive iodine-refractory differentiated thyroid cancer (RAIR-DTC) is a great challenge~     in the treatment of thyroid cancer. Tyrosine kinase inhibitors (TKIs), like sorafenib and~     lenvatinib which have been approved by food and drug administration (FDA), could not be~     affordable for most of the Chinese patients. Apatinib is a highly selective VEGFR2 inhibitor~     and reduces the angiogenesis of tumor efficiently, which had been proven effective in many~     solid tumors, is a Chinese domestic TKI targeting vascular endothelial growth factor receptor~     (VEGFR). A phase II study aims to assess the efficacy and safety of apatinib in RAIR-DTC was~     enrolled 20 patients, and 10 of them had obtained a shout-term efficacy,the study demonstrate~     the peculiar potential in treatment of RAIR-DTC. In this study, the investigators aim to~     further explore the efficacy and safety of apatinib in RAIR-DTC.~   "
39560|NCT03048864|"~     The purpose of this study is to determine if kidney stone patients who should have received~     metabolic tests (urine collection over 24-hours that determines the composition of urine)~     based on Canadian Urologic Association (CUA) guidelines did in fact receive them, and if~     these results were explained to them by their doctor.~   "
39561|NCT03048851|"~     Immediate and maintaining Efficacy of new protocols in the treatment of upper limb~     dysfunctions in patients with cerebral palsy.~   "
39562|NCT03048838|"~     Epidemiological studies have attributed the source of many new HIV and STI infections among~     MSM to primary partners. Despite recent emphasis on couples-based interventions, efficacious~     interventions for Latino male couples have yet to be tested. The proposed study builds on the~     PI's post-doctoral research in which he adapted evidence based intervention for Black MSM~     couples, Connect `n Unite, for Latino male couples using methodologically rigorous adaptation~     procedures. The adapted intervention, Conectado Latinos en Parejas (CLP) expands the~     prevention alternatives offered in previous interventions by incorporating biomedical~     prevention methods such as pre-exposure prophylaxis (PrEP), promoting engagement in care,~     adherence to treatment regimens and viral suppression (TasP) and encouraging routine HIV~     testing if appropriate given the couple's serostatus. The investigators will conduct a~     randomized control trial (RCT) to examine whether participants assigned to CLP report an~     increase in the proportion of HIV protected anal sex acts (operationalized as using condoms,~     PrEP, TasP) compared to those assigned to a Wellness Promotion (WP) time matched attention~     control. The investigators will recruit 150 Latino male couples from the Philadelphia MSA and~     randomly assign them to CLP or WP. Participants will complete ACASIs to assess behavioral and~     psychosocial factors and be tested for sexually transmitted infections (STI) at baseline, 3~     and 6 month post intervention. The investigators will conduct optional HIV/STI testing at~     baseline, 3, and 6 month post intervention. The primary study activities will be conducted at~     a large Latino serving CBO in North Philadelphia. To our knowledge, this study will be the~     first to examine the impact of a couple-based intervention to increase HIV protected anal sex~     acts for Latino male couples capable of being scaled up and replicated in various communities~     to provide continuous support and protection for this heavily impacted group.~   "
39563|NCT03048825|"~     The CLEAR SYNERGY trial will study the long term effects of treatments following PCI to treat~     ST elevation myocardial infarction. These treatments address both the culprit artery (PCI~     with SYNERGY Stent) as well as the non-culprit arteries (randomization to routine colchicine~     and spironolactone).~   "
39564|NCT03048812|"~     Dental implants are often the preferred treatment option and in some clinical scenarios they~     are considered the standard of care to restore missing or damaged teeth, due to the~     limitations of conventional treatments. For fully edentulous subjects, conventional~     tissue-supported dentures in some cases are associated with severe subjective complaints and~     difficult adaptation, mainly the mandibular denture, resulting in limited function and~     detrimental effects on oral health-related quality of life, especially for older patients.~     The use of implants to retain a mandibular denture (overdenture) has been recommended as a~     suitable and low-cost alternative to improve denture stability, with positive effects on oral~     comfort and function. The two-implant mandibular overdenture has been considered an effective~     design to achieve clinical benefits for patients. However, the main problem facing~     two-implant overdenture is the high cost of implantation and the relative complexity of the~     surgical intervention, so the use of a single midline implant to retain a mandibular~     overdenture was suggested as a more viable solution for reducing costs and complexity of~     treatment with similar benefits compared to solutions with higher number of implants.~     Nevertheless, there are few studies that compared the performance of different retention~     systems and their effects on patient-centered outcomes, such as satisfaction with the~     dentures, oral health-related quality of life, individual preferences and other subjective~     ratings of clinical outcomes. Thus, the aim of this randomized clinical trial with a~     crossover design is to investigate the changes in clinical and patient-reported outcomes~     following the use of different retention systems for a single implant-retained mandibular~     overdenture Hypothesis: it was hypothesized that clinical and patient-reported outcomes of a~     single-implant mandibular overdenture is dependent on the type of retention system, and~     patients have distinct preferences in relation to different attachments~   "
39571|NCT03048721|"~     Transcriptomics is the study of how RNA is expressed under specific conditions.~     Transcriptomic analyses of lesional skin biopsies can be a useful way to track how a patient~     responds to a drug and separate out drug responders from non-responders. However, biopsies~     are painful, carry risk of bleeding infections and scarring. A non-invasive approach, such as~     tape-harvesting, to obtain transcriptomic data from psoriatic skin would increase our~     capabilities to monitor patients on treatment and potentially help us predict if the drug~     will be effective sooner. However, it is not known how well tape-harvesting can capture~     transcriptomic changes that are occurring in psoriatic skin. The purpose of this study is to~     address how well tape-harvesting captures the transcriptomic changes that are occurring in~     psoriatic skin.~   "
39565|NCT03048799|"~     Post-prostatectomy urinary incontinence (IUPP) is a difficult to treat complication that~     causes a profound negative impact on the individual's quality of life, as well as seriously~     disrupts the physician-patient relationship and is a substantial public health problem .~     Urinary incontinence (UI) can occur both in the treatment of benign prostatic hyperplasia~     (BPH) and in the treatment of prostate cancer.~      In the treatment of benign disease, this complication is associated with a very low~     prevalence, initially of 9% and about 1% in 12 months postoperatively. In radical~     prostatectomy, the prevalence is higher, varying from 2% to 87%, depending on the populations~     and sites studied, the definitions used, the different methodologies employed in the~     evaluation of incontinence, and also the different degrees of intensity of the disease .~     Several authors have evaluated the incidence of incontinence after robotic radical~     prostatectomy, open and laparoscopically. With these techniques, the reported total UI~     incidence varies from 4% to 40% .~      With the high prevalence of IUPP, accelerating the recovery of urinary control is an~     important priority for patients and their caregivers, and the search for effective and~     low-risk treatments is a constant. Thus, the possibility of treatment with the radiofrequency~     (RF) feature arises.~   "
39566|NCT03048786|"~     Despite the availability of a variety of effective treatments for smoking cessation, uptake~     of treatments is low. The increasing use of smartphone technology presents an exceptional~     opportunity to expand access to low-cost smoking cessation services. In this pilot study, the~     investigators will use a text-messaging platform to test peer mentoring for smoking~     cessation, delivered by former smokers. While peer mentoring is a common approach to health~     behavior change, it has rarely been used to maximum effect by smoking cessation programs. The~     text-messaging platform serves as the basis for a randomized controlled trial to test the~     effectiveness of peer mentoring for smoking cessation.~      This pilot will include approximately 200 U.S. adult smokers who will be randomly assigned to~     a peer mentor or not. Participants in the control group will receive automated text messages~     used in SmokefreeTXT, a nationwide text-messaging service sponsored by the National Cancer~     Institute (NCI) in which users receive one to five automated messages per day for up to eight~     weeks. Smokers in the intervention group will receive a modified version of the same~     automated messages from SmokefreeTXT, but with additional personalized messages from an~     assigned peer mentor. Mentors will provide responses to specific questions or comments a~     smoker may have after receiving the automated messages.~      The intervention will last 8 weeks. The study includes primary outcomes to measure the~     acceptability, engagement, user experience, and early efficacy of the intervention.~   "
39567|NCT03048773|"~     Knee osteoarthritis is a common disease that causes joint pain, stiffness, and movement~     limitation. Nearly 50% in those 75 years and above are affected. In Taiwan, the reported~     prevalence was more than 6000 per year. The cause of pain is joint instability and structure~     changed, including hyaline articular cartilage lost, bony remodeling, capsular stretching and~     periartcular muscle weakness. Current guidelines for treatment of symptomatic knee~     osteoarthritis include exercise, anti-inflammatory drugs, transcutaneous electrical~     stimulation(TENS) and magnetic fields(MF) which reduce pain and improve the patient's quality~     of life.~      However, conservative therapies and oral supplements have been evaluated but are without~     clear efficacy. Prolotherapy is an injection therapy for chronic musculoskeletal pain. One of~     the hypotheses is stimulating local healing and current study demonstrated clinical benefit~     for pain and improvement of function. The effects of multi-point injections were more~     pronounced in several studies than single-point injection.~      Extracorporeal shock wave is common treatment for kidney stones, has been widely used in soft~     tissue diseases, such as calcified tendon lesions and plantar fasciitis. The theory of~     extracorporeal shock wave is energy of high-frequency vibration caused destruction of stones~     and other hard material and by increasing the rate of vascular regeneration in the injured~     area and increasing the rate of autologous tissue repair, possible biological processes~     include increased mesenchymal stem cell proliferation and differentiation, slowing the~     inflammatory response and antimicrobial efficacy. Current studies have shown equivalent~     clinical outcomes on calcific rotator cuff tendinopathy among extracorporeal shock wave~     therapy, sono-guided acupuncture and arthroscopic surgery and the extracorporeal shock wave~     has the advantage of non-invasive treatment.~      Taking the advantages of non-invasive treatment of extracorporeal shockwave. We want to~     design a randomized control trial by multi-point shockwave therapy and physical therapy~     compared with placebo shockwave therapy and physical therapy. Two randomized controlled trial~     (RCT) reported improvement in outcomes in response to shockwave therapy but were not~     methodologically rigorous. The investigators therefore conducted a two-arm RCT to assess the~     hypothesis that adults with symptomatic knee pain receiving shockwave therapy will report~     greater improvement in knee-related quality-of-life than sham shockwave therapy.~   "
39568|NCT03048760|"~     The Christie NHS Foundation Trust is one of seven sites worldwide within the Atlantic~     consortium that is developing the Elekta MR-Linac (MRL) prior to commercial release at the~     end of 2017. The MRL allows MR images of patients to be acquired before, during and following~     radiotherapy (RT). One area where The Christie is taking the lead within the consortium is~     the application of the MRL for lung imaging and treatment, an area where MRI has hardly been~     used.~      MRI scans provide greater soft tissue contrast than CT scans which can aid in the accurate~     delineation of organs at risk (OAR) and tumour target volumes for MRL and routine treatment.~     In addition, MRI can provide real time imaging which can aid in the accurate motion~     characterisation of these volumes. The addition of functional diffusion weighted imaging~     (DWI) has also proven to be useful in the discrimination of malignant from benign lesions;~     for lymph node detection and for the differentiation of tumour from atelectasis.~      Auto-contouring has the potential to speed workflows at various points in the clinical~     pathway. This may be inter-patient contour propagation used pre-treatment for plan creation,~     or may be during online or offline adaptive workflows propagating contours through imaging~     acquired as treatment progresses. In collaboration with industry the investigators will be~     testing such algorithms on these images retrospectively.~      In addition, the investigators would also like to evaluate patients' experiences of CT and~     MRI scans and determine which scanning method is preferred. Other studies have explored~     patient experiences of MRI compared to CT but not in the lung cancer patient population.~   "
39569|NCT03048747|"~     The objective of this study is to investigate the efficacy and safety of tolvaptan based on~     the change in serum sodium concentration following administration of tolvaptan oral tablets~     at 7.5 to 60 mg/day for up to 30 days in patients with hyponatremia in the SIADH.~   "
39570|NCT03048734|"~     This study to obtain pilot data on Nocturnal Hypertension and Nocturia. In Dr. Victor's~     current NIH grant (Cut Your Pressure Too: The LA Barbershop Blood Pressure Study) the results~     show that uncontrolled systolic hypertension is independent determinantal of nocturia in~     African American men.~      We now went to pursue this correlation by designing a new NIH grant Proposal to determine~     whether replacing short acting with long acting drugs and dosing them at bed time rather than~     in the morning will:~      A. Lower the systolic Blood pressure during sleep B. Improve Nocturia and results in better~     sleep quality. The results suggest that short acting hydrochlorothiazide may contribute to~     nocturia in some patients.~   "
39572|NCT03048708|"~     This study is expected to provide novel data regarding potential structural and functional~     changes of the thyroid gland in morbidly obese adults following significant weight loss~     through bariatric surgery. These data will complement evidence from epidemiological studies~     regarding the association of obesity and alterations in thyroid function. Potentially this~     study may justify further longer-term studies regarding the effects of weight gain and/or~     weight loss on the morphology of the thyroid gland and could help to form recommendations~     regarding follow-up investigations for the thyroid in morbidly obese patients.~   "
39573|NCT03048695|"~     About 85% of patients with schizophrenia have cognitive impairments, executive functions~     being particularly affected. Executive dysfunction, and cognitive deficits in general, are~     important predictors of functional outcomes, including social problem solving, activities of~     daily living, life satisfaction, and the ability to return to work or school.The main~     objective of the current study is to examine the efficacy of group-based Goal Management~     Training (GMT) for patients with broad schizophrenia spectrum disorders or high risk~     individuals with executive deficits. The short term goals are to investigate whether GMT can~     improve participants' ability to organize and achieve goals in everyday life in addition to~     improving aspects of emotional health. A long-term goal would be to establish an evidence~     base for nonpharmacological interventions for patients with broad schizophrenia spectrum~     disorders or high risk for schizophrenia. Main research questions: (1) Does a RCT with GMT~     delivered to patients with broad schizophrenia spectrum disorders or high risk for~     schizophrenia result in improved executive functioning, measured by self-reported and/or~     objective measures of executive functions? (2) Does GMT result in improved goal attainment in~     everyday life, social- and real world functioning? (3) Does GMT have a positive impact on the~     patients' emotional health? (4) Are there specific characteristics in patients with broad~     schizophrenia spectrum disorders or high risk for schizophrenia that are associated with~     better treatment benefit from GMT?~   "
39574|NCT03048682|"~     This study is a randomized controlled trial designed to assess the rate of failure of voiding~     trials in the early and late post-operative period within patients who underwent outpatient~     pelvic floor surgery that failed initial same day voiding trials.~   "
39575|NCT03048669|"~     Despite the rapid adoption of the World Health Organization's 2013 guidelines, many children~     continue to be infected with HIV perinatally because of sub-optimal adherence to the~     continuum of HIV care in maternal and child health clinics (MCH). To achieve the UNAIDS goal~     eliminating mother-to-child HIV transmission, multiple, adaptive interventions will need to~     be implemented to improve adherence to the HIV continuum. The aim of this open label,~     parallel groups, randomized controlled trial is to evaluate the effectiveness of Continuous~     Quality Improvement (CQI) interventions implemented at facility and health district level to~     improve retention in care and virological suppression through 24 months postpartum among~     pregnant and breastfeeding women receiving ART in MCH clinics in Kinshasa, Democratic~     Republic of Congo. Prior to randomization, the current monitoring and evaluation system will~     be strengthen to enable collection of high quality individual patient-level data necessary~     for the timely production of indicators and monitoring of program outcomes to inform CQI~     interventions. Following randomization, in health districts randomized to CQI, quality~     improvement (QI) teams will be established at the district level and at MCH clinics level.~     For 18 months, QI teams will be brought together quarterly to identified key bottlenecks in~     the care delivery system using data from the monitoring system, develop an action plan to~     address those bottlenecks, and implement the action plan at the level of their district or~     clinics. If proven to be effective, CQI as designed here, could be scaled up rapidly in DRC~     and other resource-limited settings to accelerate progress towards the goal of an AIDS free~     generation.~   "
39576|NCT03048656|"~     The structural leg-length inequality caused by the shortening of a segment of an extremity,~     results in an altered position of lower limb joints, the pelvis and the spine in static as~     well as dynamic conditions. That may induce a disturbance of the postural control.~      The objective of this study is to investigate the effect of the structural LLD on the control~     of the posture.~   "
39577|NCT03048643|"~     Hospitalizations for severe infections associated with opioid use disorder (OUD), such as~     infective endocarditis (IE), have doubled in the US over the past decade and are frequently~     prolonged and resource-intensive. Once medically stabilized, persons with IE but without drug~     use typically enroll in outpatient parenteral antibiotic therapy (OPAT), while persons with~     IE and OUD are kept in the hospital for the duration of therapy (often 6 weeks or more)~     largely due to concerns of ongoing drug use. Unfortunately, hospitalization for IE with OUD~     infrequently includes evidence-based medication-assisted treatment (MAT) with buprenorphine~     or methadone to address the OUD, despite the strong evidence that MAT decreases illicit drug~     use and mortality. Enrolling hospitalized persons with IE due to OUD into comprehensive MAT~     (i.e., buprenorphine + counseling) while inpatient, and providing an intensive transitional~     outpatient care program supporting MAT, may support provision of outpatient IV antibiotic~     therapy and be cost effective. The primary aim of this pilot randomized clinical trial is to~     evaluate the equivalence of current practice plus buprenorphine (keeping patients with IE due~     to opioid use disorder in the hospital for the full duration of antibiotic treatment)~     compared to OPAT plus buprenorphine (discharge with outpatient treatment once medically~     stable).~   "
39578|NCT03048630|"~     In this intervention study, the investigators engage Vietnamese American nail salon owners to~     train workers within their salons on how to reduce workplace chemical exposures. The~     long-term goal of the study is to reduce toxic chemical exposures in nail salons and promote~     worker health and safety in this vulnerable worker population.~   "
39579|NCT03048617|"~     This is an observational study of patients with Primary Mitochondrial Disease with either~     signs or symptoms suggestive of myopathy. The Investigator will identify potential patients~     through existing medical records and one on-site visit.~   "
39580|NCT03048604|"~     The study is designed as a prospective, open-label, multicentre, non-randomized, single arm~     treatment study to assess the safety, performance and initial efficacy trends of the GenioTM~     System in patients with Obstructive Sleep Apnoea (OSA).~   "
39581|NCT03048591|"~     Through the research to confirm the effectiveness and safety of using electroacupuncture in~     the treatment of chemotherapy-induced peripheral neuropathy.~   "
39582|NCT03048578|"~     This is a randomized, double-blinded, placebo-controlled trial of liraglutide versus placebo~     over a follow-up period of 12 months in patients at least 18 months following Roux-en-Y~     gastric bypass (RYGB) who are experiencing weight regain. This study will assess the efficacy~     of liraglutide in improving cardiometabolic risk profile (as indicated by serum lipids,~     HbA1c, and waist circumference) and quality of life (as assessed by PHQ-9 (Patient Health~     Questionnaire), versus placebo in patients at least 18 months following RYGB who are~     experiencing weight regain as well as the safety of liraglutide in this patient population.~   "
39583|NCT03048565|"~     This is a pilot feasibility study testing a mindfulness based intervention with caregivers of~     people with chronic illnesses~   "
39584|NCT03048552|"~     Developed from adapting and combining two evidence-based programs, Project CONNECT (a~     linkage-to-services program that targets barriers within the probation and substance abuse~     treatment systems) and TIES (a program that teaches family engagement skills to providers),~     Family CONNECT is a linkage-to-services program that targets both family and system-level~     factors to increase youth use of and retention in substance use services. Using Linkage~     Specialists embedded within probation departments, Family CONNECT will be implemented in two~     NYS probation departments. This proposed study will evaluate the impact of Family CONNECT on~     (1) youth referral from probation to substance abuse treatment, (2) youth and family~     engagement in substance abuse treatment, (3) youth enrollment/retention in substance abuse~     treatment, and (4) youth substance use and recidivism. This study will also identify family~     and probation organizational factors influencing Family CONNECT implementation in probation~     settings. 50 (+2 pre-pilot) caregiver-youth dyads and up to 36 probation officers will be~     recruited as participants in the study. Caregiver-youth dyads will be evaluated at baseline,~     2 and 6 months; probation officers at baseline, 6, 12, and 18 months; linkage specialists at~     baseline, 6, 12, and 18 months. Counts of youth referred, youth who start treatment, and~     youth retained in treatment will be obtained from the juvenile justice agency at~     pre-implementation, baseline, 2 and 6 months, counts of youth recidivism will be obtained at~     2 and 6 months.~   "
39585|NCT03048539|"~     The purpose of this study is to determine the quality of life of transoral endoscopic~     thyroidectomy compare with open thyroidectomy, Furthermore, postoperative complication will~     be assessed, also.~   "
39586|NCT03048526|"~     Patients with mild to moderate dry eye disease will be randomized to receive either~     NovaTears® or Hydrabak® eye drops as control.~   "
39587|NCT03048513|"~     Melioidosis in head and neck was observed including clinical presentation, diagnosis with~     titer, and result of treatment.~   "
39588|NCT03048500|"~     The purpose of this study is to find the benefits of combining nivolumab with metformin in~     advanced non-small cell lung cancer with and without prior treatment with immunotherapy. We~     will also be looking at the safety of the combination. Nivolumab is currently approved in~     certain cancers such as melanoma, lung cancer and kidney cancer. Metformin is approved by the~     US Food and Drug Administration (FDA) to treat diabetes. In this study, Metformin is being~     used to treat cancer. This use is not approved by the FDA; therefore, in this study, it is~     considered experimental. Experimental means the U.S. FDA has not approved the drug for use in~     your type of cancer. Nivolumab is an antibody (a human protein that sticks to a part of the~     tumor and/or immune cells) designed to allow the body's immune system to work against tumor~     cells. It is believed that metformin has immune modifying properties, meaning it can boost~     your immune system. As a result, it may help certain cancer treatments, known as~     immunotherapy, to work better.~   "
39589|NCT03048487|"~     A retrospective study of protein intake and needs as well as outcomes in critically ill adult~     patients. Data will be collected for up to 7 days of ICU stay.~   "
39590|NCT03048474|"~     This is a prospective, monocenter, single arm, phase II trial in 33 patients with~     unresectable MPM, who experience disease progression or recurrence after at least one~     previous line of platinum-based systemic treatment.~      Nivolumab will be administered at a fixed dose of 240 mg every 2 week. Nivolumab will be~     given in combination with ipilimumab on week 1, 7, 13 and 19 and will be administered prior~     to the infusion of ipilimumab. Ipilimumab will be administered at the dose of 1 mg/Kg.The~     patients will receive nivolumab monotherapy on week 3, 5, 9, 11, 15 and 17. From week 21~     thereafter, Nivolumab will be then administered every 2 weeks for a maximum period of 2 years~     or until disease progression or unacceptable toxicity occurs.~   "
39591|NCT03048461|"~     The purpose of this study is to evaluate the effect of autologous platelet-rich plasma (PRP)~     in the treatment of androgenetic alopecia.~      This is a randomized clinical trial to evaluate the effect of autologous platelet rich plasma~     in subjects with moderate androgenetic alopecia. Approximately 30 subjects will be randomized~     into the study. The study is designed as an 18-month study consisting of 2 phases. This study~     was a pilot study designed to determine feasibility of this procedure.~      Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion~     criteria will be considered for enrollment.~   "
39592|NCT03048448|"~     This study will characterize the pharmacokinetics (PK) of QAW039 after a single oral dose of~     QAW039 in patients with hepatic impairment compared to healthy matched control subjects.~   "
39615|NCT03048149|"~     This study is retrospective. It focuses on hazelnut allergic patients with a clinical history~     and a positive specific immunoglobulin E (sIgE) against hazelnut and its recombinants that~     have followed a hazelnut oral tolerance induction at the allergy Unit of Saint Vincent~     Hospital of Lille (France) since 2011.~   "
39616|NCT03048136|"~     A Study to Evaluate Safety in Participants with Chemotherapy-naïve Stage IV or Recurrent~     Non-small Cell Lung Cancer Treated With Nivolumab in Combination with Ipilimumab~   "
39617|NCT03048123|"~     The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion~     chemotherapy (HAIC) compared with transarterial chemoembolization (TACE) in patients with~     large and unresectable hepatocellular carcinoma staged BCLC A/B.~   "
39618|NCT03048110|"~     Evaluate the effect of a probe CYP3A4 inhibitor and inducer on the pharmacokinetics of~     BAY1841788 (ODM-201)~   "
39786|NCT03045926|"~     The main purpose of this study is to assess the concentration of elemental impurities in~     blood and urine after chronic administration of Smecta® in subjects with chronic functional~     diarrhoea. For exploratory purposes, the potential effects of diosmectite on bowel microbiote~     composition will be investigated.~   "
39593|NCT03048435|"~     Concurrent chemo-radiotherapy followed by intracavitary brachytherapy is standard of care for~     patients with locally advanced cervical cancer. Although curative, this treatment is~     challenging and leaves a significant proportion of women with severe toxicity, negatively~     impacting their quality of life. Although most recover over time, a proportion of women do~     not. Therefore, evaluation of quality of life becomes increasingly more important as cancer~     specific outcomes improve. One such method is through patient-reported outcomes (PROs),~     defined as any report coming directly from the patient about a health condition and its~     treatment. This prospective multi-institutional study, involving the Princess Margaret (PM),~     Odette Regional Cancer Centre(ORCC) and Royal Victoria Regional Health Center (RVH), will~     assess to feasibility and acceptability of integrating a cervical cancer specific PRO~     measurement tool into clinical practice. Cervical cancer patients coming for follow-up~     appointments will be asked to complete the EORTC QLQ-CX24, a validated cervical cancer~     specific PRO questionnaire. At the end of the study period, Feedback Forms will be completed~     by participating patients and health care providers to obtain their perspectives regarding~     the feasibility and acceptability of incorporating the instrument into clinical practice.~     Future directions include designing an electronic platform and expanding its use in cervical~     cancer clinics provincially and nationally. The data collected should help identify~     disease-related symptoms, treatment-related toxicities, facilitate patient-physician~     communication, shared treatment planning and target intervention strategies.~   "
39594|NCT03048422|"~     The purpose of this study is to compare the virologic efficacy and safety of three~     antiretroviral (ARV) regimens in HIV-1-infected pregnant women and to compare the safety of~     these regimens for their infants.~   "
39595|NCT03048409|"~     A retrospective chart review to assess feeding tolerance in adults who had been switched from~     an intact protein formula to a peptide-based formula due to feeding intolerance in a complex~     continuing care facility.~   "
39596|NCT03048396|"~     Transplantation of an uterus~   "
39597|NCT03048383|"~     The purpose of this study is to compare the effectiveness of three commercially available~     botulinum toxin neuromodulators in the treatment of facial synkinesis using patient reported~     outcome measures.~   "
39598|NCT03048370|"~     This study aims to determine if individuals with schizophrenia have greater reactivity to~     vestibular stimulation than healthy controls. The physiological response of vestibular~     stimulation will be assessed with electronystagmography, which provides a measure of the~     intensity of the nystagmus via PSPV. Positive results would suggest greater vestibular system~     reactivity to vestibular stimulation may be a biomarker of schizophrenia.~     Pathophysiologically, increased vestibular reactivity to vestibular stimulation may reflect~     abnormal vestibular function or impaired central suppression of the vestibular ocular reflex.~   "
39599|NCT03048357|"~     Observational comparison on Incidence of Pressure Injury between the Freedom Bed Automated~     Continuous lateral Rotation Therapy System and Manual Caregiver Re-positioning every 2 hours~     on a standard Hospital Bed.~   "
39600|NCT03048344|"~     Part 1 will be conducted as an open-label, non-randomized, non-placebo-controlled dose~     escalation study using pre-specified doses. Subjects with the following advanced~     hematological disorders and no available therapies, and who satisfy all inclusion/exclusion~     criteria will be enrolled. The purpose is to identify the recommended dose of oral ORH-2014~     in subjects with advanced hematological disorders.~      Part 2 will be an expansion phase conducted as a single-arm, open-label study to further~     evaluate the safety and tolerability of ORH-2014 at the maximum tolerated dose (MTD) or~     recommended dose determined from Part 1 in the fasted state. Subjects with the same disease~     types as in Part 1 will be enrolled. All subjects will receive oral ORH-2014, in the fasted~     state, at the recommended dose for an initial period of up to 12 weeks. The purpose is to~     evaluate the safety and tolerability of oral ORH-2014 in a population of subjects with~     advanced hematological disorders when administered at the recommended dose.~   "
39601|NCT03048331|"~     FES is a common and established method in the rehabilitation of persons with spinal cord~     injury (SCI). Some known effects of FES were investigated in several studies e.g. avoiding~     disuse and denervation atrophy, improving muscle force, power output and endurance changing~     muscle fibre type, increasing cross sectional area of muscle, increasing muscle mass,~     activation of nerve sprouting, reducing spasticity and motor learning.~      Most of the studies investigated the impact of FES in the lower limbs. For the upper~     extremities fewer studies exist. However, it is supposed that the effects of FES are similar.~      In the rehabilitation of persons with tetraplegia, FES, especially the stimulation of the~     upper extremities triggered by electromyography (EMG) is an established method to generally~     improve hand and arm function. However, none of those studies has investigated the effect of~     FES in combination with reconstructive tetraplegia hand surgery. Improved muscle strength is~     supposed to improve the functional outcome in participation. Additionally, FES could increase~     the motor learning process. Supported by the clinical observation we hypothesize that FES has~     a positive influence on the outcome of surgical reconstruction of tendon and/or nerve~     transfers.~   "
39602|NCT03048318|"~     Arterial flushing is a standard recommendation in deceased donor liver transplantation but~     not in living donor liver transplantation due to the risk of arterial intimal injury and~     short cold ischaemia time. There is recent evidence on benefit of retrograde arterial~     perfusion using hepatic venous occlusion and its benefits on post transplant cholestasis.~     However there is no data on antegrade arterial flushing.~   "
39603|NCT03048305|"~     The investigators collect nasopharyngeal epithelium samples from healthy individuals and~     analyze for biomarkers compared with tumor tissues from another clinical research project.~     The goal of this study is to identify molecular biomarkers for prediction of nasopharyngeal~     carcinoma.~   "
39627|NCT03047993|"~     The goal of this clinical research study is to learn if CB-839 given in combination with~     azacitidine can help to control the disease in patients with myelodysplastic syndrome (MDS).~     The safety of this drug combination will also be studied.~      This is an investigational study. CB-839 is not FDA approved or commercially available. It is~     currently being used for research purposes only. Azacitidine is FDA approved and commercially~     available for the treatment of MDS. Its use in combination with CB-839 is investigational.~     The study doctor can explain how the study drugs are designed to work.~      Up to 46 participants will be enrolled on this study. All will take part at MD Anderson.~   "
39604|NCT03048292|"~     Endovascular treatment has recently become the recommended therapy for acute stroke after the~     publication of five randomized trials (MR CLEAN1, ESCAPE2, EXTEND IA3, SWIFT PRIME4,~     REVASCAT5) in 2015 that demonstrate its efficacy. Hospitals need to adapt to these updated~     stroke care guidelines, and many hospitals are not appropriately equipped for~     neurointerventional procedures. Decreased time to treatment is associated with favorable~     clinical outcomes, and best practices to optimize workflow between comprehensive stroke~     centers and secondary hospitals have become an important area of study. This prospective~     study is being conducted on acute stroke cases within the Mount Sinai Health System from 1~     June 2016 up until 31 December 2018. The researchers would like to evaluate how variable~     methods of interventional service delivery for acute stroke affect clinical measures and~     outcomes.~      More specifically, the researchers are conducting this study in order to determine whether~     outcomes of neurointervention for large vessel occlusion in stroke, for patients presenting~     to and receiving treatment at a comprehensive stroke center, will be superior to that~     delivered by a mobilized intervention team at a central satellite hospital. In particular,~     the hypothesis is that factors affecting outcome include presentation to secondary hospital,~     delays with transfer including traffic conditions and time of day, and the acquisition of~     complex imaging within secondary hospitals.~   "
39605|NCT03048279|"~     Objectives:~      To contribute new and prospective data to our existing database library for patients with~     MEN1 and MEN2 at The University of Texas M.D. Anderson Cancer Center.~   "
39606|NCT03048266|"~     Objectives:~      The aim of the present study is to assess the significance of metabolomics and genetics in~     diagnosing and survival evaluation for pNET in the periodic follow-up of MEN1 patients.~      Aim 1: To evaluate the relationship of serum global metabolic profiles with subsequent~     development of aggressive PNET and evaluate patients survival in a nested case-control study~     of MEN1 patients who have developed aggressive PNETs (cases) and MEN1 patients who have~     developed non-aggressive PNETs (controls).~      Aim 2: Validate the top serum metabolites identified from Aim 1 in MEN1 patients who have~     developed aggressive PNETs and MEN1 patients who have developed non-aggressive PNETs, using a~     targeted metabolomics approach.~      Aim 3: Prospectively identify the potential miRNA biomarkers of serum with miRNA sequencing~     in MEN1 patients who have developed aggressive PNETs (cases) and MEN1 patients who have~     developed non-aggressive PNETs (controls).~      Aim 4: Validate the potential miRNA biomarkers identified from Aim 1 in MEN1 patients who~     have developed aggressive PNETs and in MEN1 patients who have developed non-aggressive PNETs,~     using a targeted qRT-PCR approach (in serums), as well as to see the relationship of~     potential miRNA biomarkers with patients survival.~   "
39607|NCT03048253|"~     Recombinant human GM-CSF herpes simplex virus injection (OrienX010) is a genetically~     engineered from Chinese patients oral separation of wild type 1 herpes simplex virus (HSV) as~     the carrier insert GM-CSF gene therapy drug.After gene recombination technology successively~     removing ICP34.5, ICP47 and insert the deactivation ICP6 gene, and at the site of the~     original ICP34.5 insert guided by IE promoter of hCMV human gm-csf gene.The drug after tumor~     site local injections of dosing, on the one hand, because of the soluble tumor~     characteristics of herpes simplex virus, reconstructing it after HSV-1 virus carrier at the~     injection site specific soluble tumor kill tumor cells;Viral vector expressed in tumor~     site, on the other hand, to produce high concentrations of GM-CSF enhance the antitumor~     immune function, play beside the destruction effect, have inhibition effect on the distant~     metastases.~   "
39608|NCT03048240|"~     The study pilot evaluate the feasibility of a 5-ALA- PpIX (protoporhyrin IX) mediated~     per-PDT protocol in patients with glioblastoma accessible for complete surgical removal of~     contrast. This treatment will be carried out in addition to the current reference treatment~     of glioblastoma: maximum resection surgery followed by radiochemotherapy according to the~     protocol Stupp~   "
39609|NCT03048227|"~     During this study, we propose to assess the utility of Continuous Glucose Measurements (CGM)~     in a group of Type 1 diabetic patients treated with an implanted insulin pump. Patients will~     participate in two period of 3 months separated by a 3 months washout. During one period,~     they will use CGM to adapt their insulin therapy while during the other period, they will~     manage their diabetes with their usual capillary blood glucose meter. We except to observe an~     increase of time spent in glucose safe range when using CGM.~   "
39610|NCT03048214|"~     This study aims to investigate whether infraclavicular nerve block improves acute~     postoperative pain after distal radial fracture surgery.~   "
39611|NCT03048201|"~     The primary objective of this study is to obtain long-term implant survivorship (out to 10~     years) and to assess clinical, patient-reported outcome measures, and radiographic data for~     the commercially available Physica system.~   "
39612|NCT03048188|"~     Treatment strategies of II. degree burn wounds and split-skin grafted III. degree burn wounds~     aim at reducing infection and improving reepithelialization. The aim of this study is to~     evaluate time to reepithelialization, pain, microbiology and handling of manuka honey~     dressings with second-degree burn wounds and split-skin grafted burn wounds.~   "
39613|NCT03048175|"~     Third molar (wisdom teeth) extraction is one of the most frequent intervention in dentistry.~     Nevertheless, little is known about the level of general body inflammation of subjects with~     impacted or semi-impacted third molars. Moreover, The possible effects of surgical removal of~     wisdom teeth on the overall health are not known.~      Thus, a study in which 40 subjects has been designed. Twenty subjects were affected by~     bilateral wisdom tooth pathology necessitating for extraction of both teeth. Control group~     comprised 20 subjects with absence of wisdom teeth or completely erupted wisdom teeth without~     pathology associated to or history of previous extraction of both wisdom teeth.~      In both groups a medical and dental examination will be performed at the baseline and 3~     months after baseline for the control group or after the second third molar extraction in the~     control group. Blood will be also withdrawn to assess systemic inflammation and other~     systemic parameters.~      Parameter were evaluated via high sensitive c reactive protein (CRP), lipids, fibrinogen,~     oxidative stress and endothelial function analysis.~   "
39614|NCT03048162|"~     This study is aimed to assess the effects of intravenously administered three fluid types on~     perfusion index and pulse variability index in patients during preoperative period. Patients~     will be randomly divided into three groups. Baseline, 5th, 10th, 15th, 20th, 25th and 30th~     min non-invasive blood pressure, oxygen saturation, heart rate, room temperature, perfusion~     index and pulse variability index will be measured and recorded.~   "
39619|NCT03048097|"~     In this this investigation, 15 subjects with a high probability of cardiac sarcoidosis based~     on clinical criteria and abnormal cardiac FDG uptake on initial, clinically indicted FDG PET~     study will be considered for this study. The study will test the following Aims:~      Aim 1. Effect of FDG incubation time on visual and quantitative interpretation of FDG uptake.~      Changes in incubation time can affect imaging target:background ratios and study~     sensitivity/specificity. For the study-directed exam, all patients will undergo sequential~     cardiacfocused FDG-PET imaging at 90 and 120 minutes after injection of FDG. Imaging~     variables will be evaluated as below.~      Aim 2. Reproducibility of FDG and Rb82 PET findings on sequential imaging. It is unknown~     whether FDG-positive imaging findings in cardiac sarcoidosis are reproducible. All patients~     will undergo study-directed FDG-PET/CT with MPI imaging within approximately 2 weeks from~     initial clinical scan.~   "
39620|NCT03048084|"~     Currently, treatment with a specific anti-epileptic drug mainly depends on the physicians'~     preference, as there are no studies supporting the use of one specific anticonvulsant in~     glioma patients. The overall aim of this randomized controlled trial is to directly compare~     the effectiveness of treatment with levetiracetam or valproic acid in glioma patients with a~     first seizure.~   "
39621|NCT03048071|"~     Congenital heart diseases are nowadays frequently treated in newborns. These congenital heart~     defects can directly affect the right ventricular ejection tract (RVOT), or sometimes~     indirectly, when the left ventricular ejection tract (LVOT) is replaced by the ROVT in a Ross~     operation. Originally introduced by Ross and Somerville in 1966, the reconstruction of ROVT~     by valved homografts is since then widely used.Pulmonary and aortic homografts then~     constituted the gold standard in conduit replacement between the right ventricle and the~     pulmonary artery (VD-AP).~      The increasing demand for homografts currently induces a shortage and unmet demands. This~     lack of availability, and the durability of homografts in young patients, has encouraged the~     search for alternative conducts.For example, in 1999, Medtronic® put a bovine jugular vein~     xenograft (VJB) on the market, the Contegra® conduct, as alternative for the homograft for~     RVOT reconstruction. This duct naturally has a central valve with three valvules, and there~     is on both sides of the valve a generous duct length allowing unique adaptation options. This~     conduit, however, is not perfect.~      Whether using Contegra® ducts or homografts, replacement is inevitable. The aim of this study~     is to compare operative morbidity and mortality when replacing Contegra® or homograft.~   "
39622|NCT03048058|"~     An investigator-blinded, prospective, 6 month study of subjects with persistent erythema~     associated with active rosacea will be conducted in 20 subjects aged 18 years and older. All~     subjects will receive standard-of-care brimonidine topical gel, 0.33% with instructions to~     apply it once daily per package insert. Adherence will be assessed using weekly internet~     surveys to document how often the medication is being used, as well as reminders about~     rosacea triggers and general use of brimonidine.~   "
39623|NCT03048045|"~     Patients who had had systematic periodontal treatment (antiinfective treatment with~     subgingival debridement under local anaesthesia and if required periodontal surgery) at the~     Dept. of Periodontology starting from October 2004 are re-examined 10 years +/- 12 months~     after accomplishment of active periodontal therapy (re-evaluation 1 or 2, start of supportive~     periodontal treatment) until 100 patients have been enroled. Radiographs (periapicals or~     panoramics) from start of treatment should be available.~   "
39624|NCT03048032|"~     LEDA (Lithuanian Echocardiography study of Dyspnea in Acute settings) is a prospective~     observational cohort multicenter clinical study. Project is carried out by Vilnius University~     together with a partner Lithuanian University of Health Sciences, in conjunction with a~     research protocol of international GREAT consortium (Global Research on Acute Conditions~     Team). The aim of this project is to find the specific novel biomarkers of acute heart~     failure (AHF), to evaluate their diagnostic and prognostic role in association with~     echocardiographic parameters of AHF. Primary endpoint is 1-year all-cause mortality and~     rehospitalization. Secondary endpoints are 1) in-hospital all-cause mortality 2)~     post-discharge 1 and 3 month all-cause mortality and rehospitalization 3) post-discharge 1~     and 3 month cardiovascular mortality and rehospitalization 4) one-year cardiovascular~     mortality and rehospitalization.~      During the project a sizeable national database (2000 Lithuanian patients) will be integrated~     into database of GREAT network. Novel cardiac biomarkers together with ultrasound parameters~     of right ventricular (RV) function are in the focus of the study. During the acute phase of~     heart failure, up to 15 novel cardiac, vascular, renal impairment and inflammation biomarkers~     in plasma samples will be investigated in Lithuania and France (INSERM laboratory). Plasma~     samples will be taken during 4 hours after admission and frozen at -80ºC to allow batch~     analysis. The extensive evaluation of innovative ultrasound parameters of right ventricular~     structure and function will be performed in the early hospitalization period, along with~     standard echocardiography examination. The first database of AHF patients in Lithuania will~     provide demographic data and trends of morbidity and mortality, as well as analysis of~     diagnostic and prognostic value of novel biomarkers and echocardiography parameters in the~     Baltic region. Quantitative parameters of RV systolic function and deformation will be~     measured. It is expected that optimal use of novel biomarkers and reproducible~     echocardiography parameters in the setting of emergency and critical care would reduce~     unnecessary hospitalizations, cost and hospital length of stay without decrease in the~     quality of diagnostics and treatment. An estimation of correlation of echocardiographic~     parameters and biomarkers could help create an accurate algorithm for risk stratification and~     diagnosis of AHF in an emergency setting.~   "
39625|NCT03048019|"~     Immediate potent inhibition of platelet function is critical for the prevention of~     periprocedural ischemic event occurrences in high risk N-ST segment elevation myocardial~     infarction (NSTEMI) in patients undergoing percutaneous coronary intervention (PCI).~     Currently, dual antiplatelet therapy with aspirin and an oral P2Y12 receptor blocker (with~     loading doses) is widely used for PCI. However, immediate, potent and reversible inhibition~     of platelet aggregation is not possible even with the newer oral agents, prasugrel and~     ticagrelor. Therefore, an intravenously administered GPIIb/IIIa receptor inhibitor~     (tirofiban) or P2Y12 receptor blocker (cangrelor) with fast onset and offset of actions will~     provide more desired antiplatelet effects in the setting of PCI. This study will measure and~     compare the anti-platelet effects of Tirofiban and Cangrelor in patients presenting with~     N-STEMI and undergoing PCI.~   "
39626|NCT03048006|"~     Guerbet conducted a non-interventional post-marketing surveillance study on its Magnetic~     Resonance Imaging (MRI) contrast agent Dotarem (gadoteric acid/gadoterate meglumine). The aim~     of this study, which was conducted in accordance with section 67, paragraph 6 of the German~     drug regulation, Arzneimittelgesetz, was to gain additional insights into the diagnostic~     efficacy, reliability and safety of Dotarem in routine practice using the most up-to-date MRI~     techniques and application methods.~   "
39628|NCT03047980|"~     The purpose of this research study is to gain a preliminary understanding of the safety of~     sirolimus in Sturge-Weber syndrome (SWS) and determine best outcomes to be used to assess the~     utility of sirolimus for the treatment of cognitive impairments related to Sturge-Weber~     syndrome.~   "
39787|NCT03045913|"~     This registry is a clinical post-market evaluation of the Genoss DES in subjects requiring~     coronary revascularization with Drug Eluting Stents (DES).~   "
39629|NCT03047967|"~     Despite public campaigns to prevent cigarette smoking, it's about 20% of women who keep on~     smoking during pregnancy, exposing their fetus to prenatal tobacco adverse effects. Although~     environnemental tobacco smoke exposure effects are well known, consequences of prenatal~     tobacco smoke exposure (PTSE) need better caracterization. Previous animal study from our~     group have shown, in prenatal nicotine exposed mouse pups, alterations in tracheal epithelial~     structure similar to those observed in KO α7-nAChR mouse pups. These findings support the~     hypothesis that α7-nAChR are involved in the process of deleterious effects of tobacco~     smoking on respiratory epithelium development. The purpose of the present clinical study is~     to compare PTSE neonates with controls according to lung function and respiratory epithelial~     functionality. At the age of 3 days, small respiratory epithelium fragments will be obtained~     from gentle nasal brushing performed under antalgic premedication according to the method we~     previously published. Epithelium samples will be used for in vitro studies of α7-nAChR and~     CFTR functionality. Between the ages of 2 and 6 weeks, lung function testing will be~     performed, by means of baby-body plethysmography.~   "
39630|NCT03047954|"~     The objective of this pilot double-blind study was to evaluate the efficacy and the safety of~     Broncho-Vaxom 1 capsule (3.5 mg) per day for 9 months compared to placebo on the evolution of~     the disease in children suffering from Atopic Dermatitis (AD).~   "
39631|NCT03047941|"~     The 4 following scores have been proposed to detect OSA (Obstructive Sleep Apnea): DES-OSA,~     STOP-Bang, P-SAP, and OSA50.~      The aim of this study is to evaluate the optimal cutoff value of these four scores to detect~     specifically serve OSA patients with hypoxemia.~   "
39632|NCT03047928|"~     Combination therapy is becoming more and more general in the treatment of oncological~     diseases. In this clinical trial combination the standard immunotherapeutic treatment; the~     programmed death 1 (PD-1) regulatory antibody Nivolumab and a peptide vaccine consisting of~     programmed death ligand 1 (PD-L1) and Indoleamine 2,3-dioxygenase (IDO) peptides will be~     tested in patients with metastatic melanoma. Patients will be treated with Nivolumab every~     second week as long as there is clinical benefit. The PD-L1/IDO peptide vaccine is given from~     start of Nivolumab and every second week for the first 6 vaccines and thereafter every fourth~     week up to 1 year.~   "
39633|NCT03047915|"~     This will be a randomized controlled study evaluating the effect of a music-listening~     intervention compared to standard care (control) during patient visit to the emergency~     department (ED). Randomization will be done with consecutive sealed envelopes.~      Data collection will be prospective with administration of the State Trait Anxiety Inventory~     and collection of physiologic parameters (pain level, heart rate, blood pressure).~     Retrospective data will also be collected for covariate analysis (age, race/ethnicity,~     emergency severity index (ESI), pain medications administered during the ED visit, pain~     scores throughout ED visit, chief complaint, and ED discharge diagnosis).~   "
39634|NCT03047902|"~     This is an exploratory randomised matched cohort pilot study. It is hypothesised that~     adolescents (aged 13-16 years) with asthma attending a secondary care outpatient asthma~     clinic, will disclose their smoking status to a doctor or nurse, if questioned alone without~     a parent present and if advised that they will have biological validation of their smoking~     status using a carbon monoxide monitor. It is a study of 30 subjects, who will be recruited~     over a period of 6 months.~   "
39635|NCT03047889|"~     To study the epidemiological trends and characteristics for advanced breast cancer patients,~     to analyze these trends and report the results~   "
39636|NCT03047876|"~     Many neonates and infants who undergo complex cardiac surgery are affected by neurological~     developmental delays. Whilst catastrophic events are immediately identifiable from clinical~     examination or by macro changes on MRI or CT scans, smaller changes are often not immediately~     visible or detected.~      This is an observational pilot study examining brain vascular reaction to hypothermic~     circulatory arrest with antegrade cerebral perfusion and neuro-protection techniques during~     aortic arch surgery in neonates and infants. A combination of duplex ultrasound and~     transcranial doppler will be used to record in-depth information on the cerebrovascular~     changes that occur during the entire length of the surgical procedure and during the early~     postoperative period. The proposed techniques and equipment are non-invasive and are in use~     clinically to evaluate brain perfusion in a similar age group.~      During aortic arch surgery, the patient's body and brain temperature is reduced to values~     between 18 and 24 degrees centigrade in order to decrease metabolic demand that provides a~     form of metabolic protection. However, there is no consensus within the clinical community~     regarding the optimal temperature at which to perform surgery. Moreover, in order to improve~     cerebral perfusion, the brain is perfused via the right internal carotid artery with cold~     blood. At Alder Hey Children Hospital, this surgery is undertaken by the three surgeons but,~     due to clinical preference, differs in relation to the temperature at which surgery is~     undertaken. This provides the opportunity to observe the impact of different temperatures on~     cerebral vascular reactivity in neonates and young infants The arguments for future~     comparisons and a larger randomised study will be made based on the information gained from~     this observational study.~   "
39637|NCT03047863|"~     The purpose of this study is to evaluate the therapeutic efficacy of topical EGF cream for~     dermatologic adverse events related to EGFR inhibitors.~   "
39638|NCT03047850|"~     Delta Pulse Pressure and Delta Down have been validated in surgery upon closed chest. This~     study aim to evaluate the influence of sternotomy on the value of Delta Pulse Pressure and~     Delta Down.~   "
39650|NCT03047694|"~     Lexical semantic disorders are described in Alzheimer's disease, and their incidence in~     everyday life is important to the extent that these disorders affect expression and~     comprehension.~      Providing a tactile tablet stimulation, independent and complementary to speech therapy,~     could help to maintain certain abilities and reinforce the feeling of autonomy of the~     patients.~   "
39651|NCT03047681|"~     An association between mast cells and outcomes of patients undergoing transcatheter aortic~     valve replacement (TAVR) has not been studied to our knowledge. We aim to characterize~     tryptase levels dynamics during TAVR; Demonstrate whether tryptase level post-TAVR can be~     used as a prognostic marker.~   "
39788|NCT03045900|"~     There is a deficiency in literature which compares the blending effect and color matching of~     translucent shade bulk-fill resin composite with shaded bulk-fill resin composite. So in this~     research color matching and blending effect will be instrumentally measured the by a~     spectrophotometer. A visual assessment also will be done in-vivo and ex-vivo.~   "
39639|NCT03047837|"~     Epidemiological studies and cardiovascular prevention trials have shown that low-dose aspirin~     (ASA) can inhibit colorectal cancer (CRC) incidence and mortality, including inhibition of~     distant metastases. Metformin (MET) has also been associated with decreased CRC incidence and~     mortality in meta-analyses of epidemiological studies in diabetics and has been shown to~     decrease by 40% colorectal adenoma recurrence in a randomized trial. Recent studies have~     shown that ASA is an inhibitor of mTOR/S6K1 and an activator of AMPK, targeting regulators of~     intracellular energy homeostasis and metabolism, and that the combination of ASA and MET,~     another AMPK activator and S6K1 inhibitor, has a striking additive effect on AMPK activation~     and mTOR inhibition, with increased autophagy and decreased cell growth in CRC cell lines.~     While both drugs are being tested as single agents, their combination has not been tested in~     trials.~      This is a randomized, placebo-controlled, double blind, 2x2 biomarker trial of ASA and MET to~     test the activity of either agent alone and the potential synergism of their combination on a~     set of surrogate biomarkers of colorectal carcinogenesis. After surgery 160 patients with~     stage I-III colon cancer will randomly be assigned in a four-arm trial to either ASA, 100 mg~     day, MET 850 mg bid, their combination, or placebo for one year. The primary endpoint~     biomarker is the change, defined as the difference between pre- and post-treatment expression~     of nuclear factor kappa-B (NFκB), in the unaffected mucosa of proximal and distal colon~     obtained by multiple biopsies in two paired colonoscopies one year apart. Additional~     biomarkers will include: 1) the genomic profile of candidate genes, pathways, and overall~     genomic patterns in tissue biopsies by genome wide gene expression arrays; 2) the IHC~     expression of tissue pS6K, p53, beta-catenin, PI3K; 3) the associations of mutations and SNPs~     with treatment response by next generation sequencing of primary tumors; 4) the measurement~     of circulating IL-6, CRP and VEGF and 5) plasma and colonic MET concentrations and their~     correlation with biomarker profiles.~   "
39640|NCT03047824|"~     After providing written informed consent, the first 20 Subjects meeting Inclusion/Exclusion~     Criteria will be consecutively enrolled in the Standard of Care cohort. The moderate~     treatment cohort will then be consecutively enrolled, followed by the tight glycemic control~     cohort.~      After sensor insertion, baseline evaluations including APACHE II, SOFA, and laboratory~     evaluations will be determined.~      Subjects enrolled in the standard of care cohort will be treated according to the~     institution's protocol for measuring glucose and managing insulin. These subjects will be~     monitored on a GlucoClear System but they will not be managed based on the values or trends~     of the GlucoClear system.~      Subjects enrolled in the treatment cohorts will be monitored and managed with a special~     version of the GlucoClear continuous monitoring system. This system contains the GlucoClear~     Insulin Dosing Algorithm providing insulin dosing recommendations to enable the clinician to~     manage patient glucose within pre-specified target levels. These recommendations are~     presented on screen for a clinical professional to approve or override.~      Subjects in the moderate treatment cohort will have their glucose managed in the range of 120~     - 180 mg/dl. Subjects in the tight glycemic control treatment cohort will be managed in the~     range of 80 - 120 mg/dl.~      After discharge from the ICU, subjects will followed for adverse events and mortality at 30~     days, either by telephone contact or office visit.~   "
39641|NCT03047811|"~     The study of targeted NY-ESO-1 T cell receptor (TCR) genetic modified autologous T cells~     treatment of advanced solid tumors~        1. The main purpose - security and ORR;~        2. A secondary purpose - median progression-free surial;1 year, 2 years, total 5 years~          survival rate;The quality of life.~   "
39642|NCT03047798|"~     This study aims to evaluate the effect of novel mouthrinse formulations containing bamboo~     salt, magnolia bark and centella asiatica extracts on gingivitis and dental plaque.~     Participants uses mouthrinses which contain bamboo salt, magnolia bark and centella asiatica~     extracts and the same participants will also use placebo for tooth brushing by cross-over~     design.~   "
39643|NCT03047785|"~     Currently when defining the upper limit of normal (ULN) or 99th percentile of a troponin~     assay manufacturer's use a healthy population traditionally aged 18-40. The 99th percentile~     value is the recommended value to use when diagnosing patients with an acute myocardial~     infarction. With the advent of the new highly sensitive troponin assays it has become clear~     that many patients have a troponin level above the 99th percentile when they have not~     suffered a myocardial infarction. We believe part of the problem with interpreting the the~     troponin values for patients is that the 99th percentile value which determines the ULN has~     been derived from population that is very different to the hospital population of patients.~     This study aims to demonstrate what the 99th percentile is for the population of people who~     use the hospital services who are traditionally older and have more comorbidities when~     compared to the population traditionally used to define the 99th percentile of a troponin~     assay.~   "
39644|NCT03047772|"~     The benefit of current stem cell transplantation therapy for myocardial infarction is limited~     by low survival rate for stem cell. The purpose of this study is to test whether intensive~     Atorvastatin therapy can improve the outcome of patients with impaired left ventricle~     function after acute myocardial infarction who underwent intracoronary transfer of autologous~     bone marrow mesenchymal stem cells.~   "
39645|NCT03047759|"~     Comparison of Two interdental cleaning devices on plaque removal, gingivitis and bleeding.~   "
39646|NCT03047746|"~     This is a single arm pilot study using TCR alpha/beta+ T cell-depleted peripheral blood stem~     cells (PBSC) from closely matched unrelated donors or partially matched/haploidentical~     related donors for hematopoietic stem cell transplant (HSCT) in patients with acquired and~     inherited bone marrow failure (BMF) syndromes.~   "
39647|NCT03047733|"~     OBJECTIVE: To investigate the efficacy of the cyclic on-off treatment compared to the~     conventional continuous excimer laser treatment.~      DESIGN: A randomized, controlled, split-body, non-inferiority study. SETTING: The trial was~     performed in two tertiary health care centers in Korea.~      PARTICIPANT: Twelve patients (16 pairs of lesions) with stable symmetric vitiligo less than 5~     years' disease duration were enrolled.~      INTERVENSION: The paired symmetric vitiliginous lesions were randomized to either the~     continuous or the cyclic on-off treatment. All lesions were treated twice weekly for 9-month:~     continuously, or cyclically with 2-month treatment and 1-month intermission (total 3 cycles).~     Topical tacrolimus was applied throughout the trial.~      OUTCOME MEASURES: The repigmentation was assessed using an image analysis program with~     clinical photographs. The primary outcome was mean difference of repigmentation rates and the~     non-inferiority margin was set at 10%. During intermission period, the clinical changes such~     as loss of repigmentation or worsening of the vitiligo lesions were assessed.~   "
39648|NCT03047720|"~     This study is a simple effectiveness trial to determine if the Lully Sleep Guardian has any~     effect on benign nocturnal enuresis.~   "
39649|NCT03047707|"~     The purpose of this multi-center prospective study is to evaluate the diagnostic performance~     of S-Shearwave, a newly developed ultrasound shear wave elastography, for the assessment of~     hepatic fibrosis.~   "
39652|NCT03047668|"~     Basic treatment of type 2 diabetes should focus on diet, physical activity and lifestyle.~     Nevertheless, in early and late stage of T2DM, lifestyle intervention is mostly substituted~     by pharmacological intervention, although lifestyle modification and dietary treatment would~     be favourable.~      The researchers therefore investigate dietary strategies such as low-carb and very-low calory~     diets regarding their potential to improve metabolism and body weight in (mostly) long-term~     T2DM patients. This core comparison is dealt with in the DiNA-D study (published elsewhere).~      POLYPHEM targets specific dietary approach to preserve the achieved metabolic improvements~     from DiNA-D phase 1. Nutritional factors will be PUFAs and BCAAs.~   "
39653|NCT03047655|"~     A growing number of cross-sectional studies is investigated the role of the human lipidome as~     a new biomarker for metabolic diseases. However, data on this issue is still sparse and~     especially interventional data is not available up to now.~      GesundLeben will provide data on 100 human subjects with metabolic syndrome, undergoing~     distinct types of lifestyle intervention for 6 weeks. Standardized metabolic assessment will~     be covered with routine laboratory parameters and oral glucose tolerance test as well as~     non-radiologic anthropometric measurements.~   "
39654|NCT03047642|"~     This project aims to evaluate the performance characteristics of rapid tests to differentiate~     bacterial from non-bacterial infection in febrile adults and children presenting at OPDs~     (outpatient departments) i.e.(fever triage assays) in three LMICs. The evaluation will~     include a different commercial biomarker combinations as well as individual biomarkers to~     assess their individual or combined value in the target population. Markers will be evaluated~     onsite in ELISA or RDT format, as appropriate. Further, this study aims to contribute to a~     centralized biobank of well-characterized specimens for use by IVD companies and academic~     institutions for the development and evaluation of emerging assays.~   "
39655|NCT03047629|"~     This is a Phase 1/2a study to assess the safety, tolerability, pharmacokinetics, and~     pharmacodynamics of an orally-administered medication to relieve symptoms of constipation~     associated with Parkinson's Disease. Ten patients will be enrolled in Phase 1, and will be~     studied over an 8-12 week period. Forty patients will be enrolled in Phase 2, and will be~     studied over an 8-10 week period. All subjects will receive the study drug during one of the~     observational periods of the study.~   "
39656|NCT03047616|"~     Several immune checkpoint inhibitors targeting the PD-1 pathway have been developed with~     clinical trials showing an approximately 20% durable response in unselected patients with~     advanced non-small cell lung cancer (NSCLC). At the moment, no clear biomarker exists to~     accurately predict anti-PD1/PDL1 tumor responsiveness. The goal of this study is to broadly~     discover and evaluate the utility of blood based biomarkers for use in measuring and~     predicting response to immunotherapy in patients with lung cancer.~   "
39657|NCT03047603|"~     The incidence of Hepatocellular carcinoma (HCC) is increasing worldwide. However, most of HCC~     cases were at advanced stage when the diagnosis established.Early diagnosis improves the~     prognosis.The study is intended to evaluate the diagnostic efficiency of Protein Induced by~     Vitamin K Absence or antagonist-II(PIVKA-II). This study is a international multicenter study~     joined by several hospitals in China,Singapore,Thailand and Vietnam. Participants including~     healthy control,HCC,metastatic liver cancer,Hepatitis B virus(HBV) and liver cirrhosis are~     consecutively recruited into the cohort. All the serum samples are collected before any~     treatments and will be tested in single center in order to decrease bias. Serum samples were~     tested for PIVKA-II,alpha-fetoprotein and biochemical indexes including alanine~     aminotransferase(ALT),aspartate aminotransferase(AST),gamma-glutamyl~     transferase(GGT),alpha-l-fucosidase(AFU),etc.~   "
39658|NCT03047590|"~     This study will evaluate adherence to four types of walking programs. Participants will be~     randomized to walking programs that included either (1) affect-based exercise intensity, (2)~     self-selected (or choice-based) exercise intensity, (3) heart-rate based exercise~     intensity, or (4) heart-rate guided exercise intensity with the emphasis on affective~     benefits.~   "
39659|NCT03047577|"~     Patients non-electively admitted to intensive care units (ICUs) will be screened for~     eligibility. The investigators will include adult patients with risk level alcohol use,~     defined by AUDIT-C score (>5 for females, >6 for males). Informed consent will be obtained~     from the patient in the end or shortly after the ICU treatment, when they have regained~     sufficient cognitive function. 600 patients will be randomized to receive either routine~     treatment or a brief intervention (BI). The BI includes a 20 minute discussion with~     pre-educated study personnel, option to discussion with a social worker and written material.~     Primary outcome measure is the amount of alcohol used during the preceding week (g/week), at~     6 and 12 months after study entry. The information will be obtained 1)in an interview by a~     study team member blinded for the intervention arm at 6 months 2) A letter of a telephone~     interview at 12 months. AUDIT score, EQ-5D and mortality will also be recorded.~   "
39660|NCT03047564|"~     Metal ion release from metal implants may have side effects. It can be reduced by coating of~     the implant. This study compares coated and uncoated TKA.~   "
39661|NCT03047551|"~     The investigator will perform a multicenter, randomized controlled trial in practices that~     routinely use transvaginal sonography (TVS) to compare how often clinicians order additional~     testing prior to medical abortion after the use of either TVS or transabdominal ultrasound~     (TAS) in medical abortion eligibility assessment. Women will be randomized to receive either~     TVS or TAS prior to medical abortion. We anticipate enrolling 800 patients receiving care~     from about 30 providers over 6-8 months.~      The primary study outcome will be the proportion of women that requires additional evaluation~     after sonography, prior to determination of medical abortion eligibility. The second primary~     outcome will be patient satisfaction, determined by a patient satisfaction questionnaire~     utilizing a visual analog scale.~   "
39662|NCT03047538|"~     The aim of this study is to compare the effect of fixed and free combination of~     atorvastatin/perindopril/amlodipine on blood pressure and lipid levels.~   "
39682|NCT03047278|"~     This study aims to investigate the influence of the glycemic control of type 2 diabetes (DM2)~     and of cetirizine (OCT2 inhibitor) on gabapentin kinetics disposition and~     pharmacokinetics-pharmacodynamics (PK-PD) in patients with neuropathic pain. Thus,~     non-diabetic patients (Control Group, n=10), patients with controlled diabetes (n=10) and~     patients with uncontrolled diabetes (n=10), all with neuropathic pain of intensity ≥ 4 in~     pain visual analog scale (0-10) are being investigated.~   "
39663|NCT03047525|"~     Background: Combinations of Dendritic and Cytokine-induced Killer Cells (DC-CIK) and~     Cytokine-induced Killer Cells (CIK) treatment may enhance the immune response and stop cancer~     cells from growing. The investigators suppose that DC-CIK combined with CIK treatment will~     improve the prognosis of advanced solid tumors.~      Objective: Phase II clinical trial to investigate the efficacy of concurrent chemotherapy~     with DC-CIK and CIK treatment in patients with treatment-refractory solid tumors.~      Study treatment:~      Patients in group A will receive 4 cycles of CIK treatments and 4 cycles of DC-CIK treatments~     within 8 months. Patients in group B will have no immunotherapy . chemotherapy are available~     in both groups.~   "
39664|NCT03047512|"~     Major depression is a highly prevalent and severe mental disease that negatively alters the~     lives of people, their families, and their social environment.~      Organizations that promote mental health policies have recognized the potential of new~     information technologies for the prevention and treatment of mental disorders. In this~     direction, information and communication technologies (ICTs) generate opportunities for~     increasing patient well-being through the use of on-line software. Such programs often~     include interactivity, self-monitoring, information materials (sometimes in multimedia~     format), and exercises on problem solving, recognition and challenging of dysfunctional~     thoughts, scheduling of activities, behavioral experiments, and other psycho-educational~     activities.~      In Colombia, there are few preventive mental health interventions scientifically oriented and~     seeking to demonstrate efficacy in context.~      The purpose of this study is to determine whether an internet-based program is effective to~     prevent and to intervene early the depression in adolescents between 11 and 20 years of age~     in 2 schools in the Antioquia Region, Colombia.~   "
39665|NCT03047499|"~     Evaluation of the effect of botulinum toxin type-A injection prior to surgical correction of~     complete unilateral cleftlip repair by modified millard cheiloplasty~   "
39666|NCT03047486|"~     The reference treatment of the type 1 diabetes is intensified insulin therapy by insulin~     pump. The CGM (continuous glucose monitoring) is a technology available for a decade, which~     allows the continuous measure of interstitial glucose rate. The results are available in real~     time to the user, who can so use them to optimize the adjustment of its treatment by insulin~     pump. Since a few years, several research programs aim for finalizing an automated system~     using the data of real time interstitial glucose to adjust automatically, via an algorithm,~     the release of insulin by the pump. This type of closed-loop system is for the moment only~     experimental, not still widely available in routine. On the other hand, rudimentary~     regulation systems partially automated already exist and can be used in common clinical~     practice. One of these systems, Smartguard ®, allows this type of regulation to decrease the~     hypoglycemic risk of the patients treated by insulin pump. It is indeed a hypo minimizer~     which interrupts the basal output when the algorithm embarked on the pump determines thanks~     to the CGM data what a hypoglycemia risks to occur in the 30 minutes. The efficiency of this~     system to reduce hypoglycemias was proved by several studies in pediatric and adult~     populations of subjects with DT1 (Diabetes Care on 2015; 38:1197-1204. J Diabetes Sci~     Technol. 2016 May 20. Pii: 1932296816645119). However, to date, there are no published data~     concerning the method of use of this system (sensor et pump initial configuration; patient~     education), nor the evolution of the sensor and pump parameters during the use.~      The aim of this observationnelle study is to collect the data of efficiency, safety and use~     of the system Smartguard ® in common clinical practice in an adult population of subjects~     DT1.~   "
39667|NCT03047473|"~     This is a safety and tolerability study looking at the addition of avelumab, an immune~     checkpoint inhibitor, to standard therapy of temozolomide and radiotherapy in patients with~     newly diagnosed glioblastoma multiforme.~      All patients will be receiving active therapy. Patients will begin the avelumab within 3~     weeks of finishing their radiotherapy. Avelumab will be given at a dose of 10mg/kg IV every 2~     weeks concomitantly with the monthly temozolomide. Avelumab will be continued for a total of~     52 weeks.~   "
39668|NCT03047460|"~     The establishment of a biomarker(s) that can predict a clinical response to therapy over the~     course of a 1-2 year clinical trial is critical for the expeditious development of treatments~     for Multiple Sclerosis (MS). Identification of this biomarker would enable shorter and~     smaller clinical trials resulting in the faster development of much needed treatments for MS,~     specifically neuro-reparative therapies. The etiology of disease progression is conduction~     block, demyelination and axonal degeneration. Evoked potentials provide a direct assessment~     of the underlying etiologies of disease progression in MS. They are a functional assessment~     of multiple pathways, including visual, motor and sensory, evaluating the integrity of myelin~     and axons.~      The variability of motor evoked potentials (MEP) measures has limited multimodal evoked~     potential (mmEP) use in international, multicenter clinical trials. MEP evaluation does~     significantly contribute to the predictive value of mmEP's. Recent advances in technology and~     establishment of standardized protocols for MEP reduces the variability associated with this~     procedure. The objective of this study is to evaluate the reliability and feasibility of MEP~     and SSEP in an international, multicenter trial so that mmEP can be further evaluated as a~     biomarker for disease progression. The rationale for this study is to explore the feasibility~     and reliability of MEP's and somatosensory evoked potentials (SSEP's) in a multicenter~     clinical trial for potential use as a biomarker that can predict clinical~     progression/improvement in international clinical trials evaluating remyelinating therapies.~      Study Objectives and Endpoints:~      Objective:~      The primary objective of the study is to evaluate the feasibility and test-retest reliability~     of MEP's and (SSEP's) in a multicenter clinical trial in healthy subjects and subjects with~     MS.~      Endpoints:~      The primary reliability endpoint will be the intraclass correlation coefficient (ICC) of the~     following evoked potential parameters~      Motor Evoked parameters that will be measured:~        -  MEP latency~        -  Central motor conduction time (CMCT) root latency methods~        -  MEP amplitude~        -  MEP amplitude to compound motor amplitude ratio (MEP-M ratio) for the right and left~          abductor digiti minimi (ADM) and the right and left tibialis anterior (TA)~        -  Somatosensory evoked potential parameters will include Evoked potential latencies for~          both upper and lower limbs bilaterally.~      Study Design:~      This multinational, multicenter study will be conducted in healthy adult volunteers and MS~     patients to establish the feasibility and reliability of mmEP's. A total of 40 subjects, 10~     (5 healthy and 5 MS) from each of the 4 sites will be enrolled.~      The study will consist of two visits, 1-30 days apart, during which subjects will be screened~     to confirm eligibility and will complete all specified study assessments.~      Study Locations:~      Canada, Germany, Switzerland and Italy, with 1 site in each country.~      Number of Planned Subjects:~      A minimum of 40 subjects are planned for this study. Subjects who withdraw from the study~     prior to completion of the second visit may be replaced at the discretion of the~     investigator.~      Study Population:~      This study will be conducted in subjects 25 to 58 years of age, inclusive, who are either~     healthy volunteers (HV) or have been diagnosed with clinically definite MS who have a~     detectable lesion by MEP or SSEP.~      Study Groups:~      Two groups, healthy volunteers and clinically definite MS will be included.~      Duration of Study Participation:~      Study duration for each subject will be two visits, the second visit schedule >24 hours-30~     days from the first visit~      Criteria for Evaluation:~      Key Study Assessments:~      Electrophysiological. MEP's and SSEPs will be measured in both upper and lower limbs~     bilaterally. All studies will be read locally and reviewed by a blinded reader at another~     center. The ICC of every measured evoked potential parameter will be determined on both the~     central and local reads.~   "
39669|NCT03047447|"~     Original research article entitled Induced and Controlled Dietary Ketosis as a Regulator of~     Obesity and Metabolic Syndrome by Madeline Gibas for consideration for publication in a~     clinical journal. This research manuscript builds on previous landmark studies that report~     that major weight and fat mass loss in type II (T2D) patients who were fed a very low~     carbohydrate, ketogenic diet. In this manuscript, the investigators outline our research~     study that showed statistically significant (p < 0.05) changes over time in hemoglobin A1c,~     weight, BMI, body fat percentage and ketones for patients with metabolic syndrome who were~     fed a very low carbohydrate diet, ketogenic diet.~   "
39670|NCT03047434|"~     2.1Purpose: The purpose of this study is to describe the chronology of postoperative pain in~     patients undergoing shoulder, knee, ankle arthroscopy. Further, within this population the~     predictive validity of the Defense and Veterans Pain Rating Scale will be assessed for~     persistent post surgical pain.~      2.2 Research Design: This is a prospective descriptive correlational design looking to~     characterize postoperative pain variables across various procedures that historically have~     significant levels of persistent post-surgical pain. Further, bivariate correlations at~     different time points will be examined to see how DVPRS along with Pain Assessment Screening~     Tool and Outcomes Registry (PASTOR) correlates with other measures.~      2.3 Methodology/Technical Approach A total goal of 250 participants will be queried regarding~     their postoperative pain experience following shoulder arthroscopy and knee arthroscopy.~     Descriptive multidimensional tools (the DVPRS and the electronic Pain Assessment Screening~     Tool and Outcomes Registry (PASTOR)) will be used preoperative either during their~     preoperative surgical visit or the day of surgery and extending to 6 months postoperatively.~     As these tools have been utilized in previous studies for the prediction of persistent post~     surgical pain, the DVPRS will additionally be evaluated for its predictive validity as it is~     a short, easy-to-administer, bedside tool.~   "
39671|NCT03047421|"~     DES-OSA and P-SAP scores have been validated to detect OSA (Obstructive Sleep Apnea).~      One item of P-SAP and DES-OSA is the measurement of neck circumference. The aim of this study~     is to compare the influence of different methods of neck circumference measurement in the~     accuracy of DES-OSA and P-SAP scores to detect OSA.~   "
39683|NCT03047265|"~     This is a Phase II Randomized Trial to Compare Paclitaxel combined with DDP Plus Concurrent~     Chemoradiotherapy With DDP Plus Concurrent Chemoradiotherapy in Patients With Locoregionally~     Advanced Nasopharyngeal Carcinoma~   "
39672|NCT03047408|"~     About 60% of Parkinson's Disease (PD) patients have REM sleep Behavior Disorder (RBD), a~     parasomnia characterized by partial or complete loss of REM sleep muscle atonia and~     dream-enacting behaviors, usually associated to vivid dreams. The REM Sleep without atonia is~     the polysomnographic hallmark of RBD, and its quantification is necessary for the diagnosis.~      RBD in PD is believed to be a marker of a more widespread degenerative process and a marker~     of malignant phenotype. Therefore, PD patients with RBD (PD-RBD) are more severely impaired~     in both motor and non-motor domains, compared to those without RBD, with an increased risk of~     dementia. However, little is know about the relationship between the evolution of RBD, clinic~     and video-polysomnographic, and the progression of PD. Besides, an improvement of RBD~     symptoms is anecdotally reported in PD patients over time. Longitudinal evaluation of RBD in~     PD, assessed by questionnaires, led to controversial results, but so far, no longitudinal~     vPSG study has been performed in PD-RBD population.~      Thus, the main objective of this study is to longitudinally evaluate clinical and~     video-polysomnographic features of RBD, including measure of REM Sleep without atonia, in~     patients with PD-RBD, after three years from the diagnosis of RBD, in order to ascertain~     whether RBD features remain stable over time. The possible remission of RBD with the~     progression of PD would question indeed its reliability as prognostic bio-marker.~   "
39673|NCT03047395|"~     The purpose of this study is to investigate the long-term safety and efficacy of risankizumab~     in the treatment of moderate to severe chronic plaque psoriasis.~   "
39674|NCT03047382|"~     Around a third of patients who develop acute kidney injury (AKI) do so after a hospital~     admission (hospital-acquired - HA-AKI).~      The primary aim of the study is to prospectively test whether introducing a complex~     intervention (a 'care package' - comprising a clinical prediction rule incorporating an~     electronic alert which generates a checklist for patient management to relevant health~     professionals) can identify patients on admission to hospital who are at risk of developing~     HA-AKI, highlight the need for closer monitoring and allow putative preventative measures to~     be put in place.~      The investigators will introduce the care package in one acute hospital and evaluate its~     effectiveness in reducing HA-AKI and its associated morbidity, over ten months, compared to a~     sister hospital within the same Trust (which will act as a control site). The investigators~     will extend evaluation for a further ten months to assess sustainability on the first site~     and introduce the package at the control hospital to assess generalisability. The primary aim~     is reducing HA-AKI, but secondary aims will include improved outcomes associated with HA-AKI,~     management of patients already with AKI on admission to hospital (whose care may also benefit~     from the checklist) and a cost-effectiveness analysis.~   "
39675|NCT03047369|"~     This is an observational designed to:~        -  Aim 1: Define novel homogeneous groups of patients with unclassified leukodystrophy and~          work toward finding the cause of these disorders;~        -  Aim 2: Assess the validity and utility of next-generation sequencing in the diagnosis of~          leukodystrophies;~        -  Aim 3: Establish disease mechanisms in selected known leukodystrophies;~        -  Aim 4: Track current care and natural history of these patients to define the~          longitudinal course and determinants of outcomes in these disorders.~      These objectives will be achieved by collecting, and subsequently analyzing, data and samples~     in a longitudinal fashion across leukodystrophies.~   "
39676|NCT03047356|"~     A trial that tests whether implementation intentions improve sleep among adoelescents.~   "
39677|NCT03047343|"~     Pulmonary artery strapping is a surgical technique aimed at providing a palliative treatment~     to newborns suffering from congenital heart defects, characterized by an increase in blood~     flow and pulmonary blood pressure.~      The intervention consists of placing a band around the pulmonary artery. This band causes an~     artificial stenosis, therefore inducing a reduction of the pulmonary arterial pressure. It~     acts as a first step, preparing the ground for a future definitive repair intervention.~      It is mainly used in the context of septal defects, atrio-ventricular canal defects or~     uni-ventricular hearts.~      The complications linked to strapping include, among others, the erosion of the band in the~     artery lumen, its migration and the obstruction of the pulmonary artery, a pulmonary valvular~     insufficiency, the obstruction of the coronary artery and an ineffective strapping.~      The early mortality rate of pulmonary artery strapping after 1980 varies between 1.8% and~     13.6%, while strapping readjustment rates oscillate around 20%. It is assumed that the~     mortality is linked to the nature of the cardial malformation (uni-ventricular or~     bi-ventricular) rather than the procedure itself.~      This retrospective study aims to evaluate the intra-hospital and extra-hospital mortality~     rate of pulmonary artery strapping, as well as the readjustment rate within two groups of~     patients: those benefiting from an uni-ventricular cardiac reparation and those benefiting~     from a bi-ventricular cardiac reparation. The aim is to determine the short term mortality~     rate of the intervention and the incidence of complications within the hospital, within the~     two groups.~   "
39678|NCT03047330|"~     This study aims to investigate the impact of menopause-related sleep fragmentation on~     metabolic biomarkers of body fat gain. The investigators hypothesize that experimental sleep~     fragmentation will result in an adverse leptin response as a metabolic biomarker for body fat~     gain.~   "
39679|NCT03047317|"~     This is an open label study of MABp1 in six healthy volunteers. Participants will receive a~     single infusion of MABp1 at the 7.5 mg/kg IV dose. Participants will undergo blood sampling~     for pK analysis at 15 times points during the course of 2 weeks (pre-infusion, 0.5 hr, 1 hr,~     1.5 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 12 hr, 24 hr, 48 hr, 96 hr, 192 hr, and 336 hr). In~     addition to pharmacokinetic data, participants will be monitored for the development of~     treatment emergent adverse events.~   "
39680|NCT03047304|"~     Magnesium is a known treatment for neuroprotection in preterm labor before 32 week of~     gestation. High concentration of Magnesium in the blood stream known as cause of conduction~     abnormalities and ECG changes such us prolonged QT, QRS and PR in about. The goal of our work~     is to evaluate the PR intervals in embryos after maternal treatment with magnesium during~     preterm labor.~   "
39681|NCT03047291|"~     Evaluate clinically and microbiologically the effect of the oral probiotic Lactobacillus~     reuteri Prodentis (PerioBalance®, Sunstar, Switzerland) on implants with mucositis or~     periimplantitis, as a coadjuvant treatment of mechanical therapy.~   "
39684|NCT03047252|"~     The study was designed to compare the outcomes of a home-based rehabilitation program using a~     novel kinematic biofeedback system in the rehabilitation after total knee replacement.~      This system allows the patients to perform independent rehabilitation sessions at home, under~     remote monitoring from the clinical team.~      The investigators hypothesize that the clinical outcomes of a home-based rehabilitation~     program will be at least similar to the outcomes of a traditional home-based rehabilitation~     with face-to-face sessions.~      This is a randomized controlled trial with active comparator. Patients will be enrolled~     pre-operatively and divided into 2 groups: experimental group and conventional rehabilitation~     group. Both groups will perform 8 weeks of rehabilitation starting between day 7 and 10 after~     surgery.~      The experimental group will perform daily rehabilitation sessions at home using the system,~     under remote monitoring from a physical therapist. The conventional rehabilitation group will~     perform 1h rehabilitation sessions 3 times a week, at home, given by a physical therapist.~      Outcomes will be measured at weeks 4 and 8 and then at 3 and 6 months. The primary outcome is~     the change in performance in the Timed-up-and-Go (TUG) test in comparison with the~     pre-operative score. Secondary outcomes will be measured in terms of: b) Knee Osteoarthritis~     Outcome Score); c) range of motion of the knee joint (flexion/extension);~   "
39685|NCT03047239|"~     Baseline 24-hour SENSIMED Triggerfish (TF) recordings as well as functional and structural~     vision tests measured prospectively every 3 months over a 2-year period, will be used to~     model TF's ability to serve as a risk factor for individual progression rates.~   "
39686|NCT03047226|"~     The purpose of this study is to determine the proportion of patients diagnosed with Lynch~     syndrome in colorectal cancer patients with the loss of staining by immunohistochemistry~     (IHC) of any of the mismatch repair (MMR) proteins. Besides, this study aims to test the~     specificity and the sensitivity of detecting microsatellite instability (MSI) by~     next-generation sequencing, and to find out the consistency between IHC and MSI in colorectal~     cancer patients in China. In addition, researchers want to analyze the clinical~     characteristics and germline mutation of Lynch syndrome in Chinese population.~   "
39687|NCT03047213|"~     This pilot phase II trial studies how well sapanisertib works in treating patients with~     bladder cancer that has spread from where it started to nearby tissue or lymph nodes (locally~     advanced) or other places in the body (metastatic) with tuberous sclerosis (TSC)1 and/or TSC2~     mutations (changes in deoxyribonucleic acid [DNA]). Sapanisertib may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth.~   "
39688|NCT03047200|"~     The purpose of this study is to further test islet cell transplant in patients who have had a~     kidney transplant. This study will also evaluate the safety and effectiveness of the~     anti-rejection medications used to prevent rejection after your islet cell transplant.~   "
39689|NCT03047187|"~     Objectives:~        1. To examine the ability of ACLR patients at discharge from rehabilitation to perform a~          single-hop for distance.~        2. To examine isometric muscle strength of ACLR patients at discharge from rehabilitation.~        3. To examine ACLR patients' self-reported knee function at discharge from rehabilitation~        4. To assess the psychological factors for ACLR patients at discharge from rehabilitation.~        5. To correlate single-hop for distance with self-reported knee function, strength and~          psychological factors for ACLR patients at discharge from rehabilitation to discover~          whether any of these factors can predict the others.~   "
39690|NCT03047174|"~     The aim for the present study named RAREST (RAdiotherapy RElated Skin Toxicity) is to compare~     the new dressing with the standard skin care. 168 patients receiving radiotherapy alone or~     radiochemotherapy for locally advanced head-and-neck cancer will be included. The primary aim~     is to investigate the rate of patients experiencing severe, stressful radiation dermatitis.~     The skin status will daily be inspected and assessed by specially trained doctors and nursing~     staff.~      It is expected that the new self-adhesive dressing is superior to standard care with respect~     to prevention of grade ≥2 radiation dermatitis in patients receiving radiotherapy or~     radio(chemo)therapy for a head-and-neck tumor. Thus, the dressing would be well qualified to~     become a new standard procedure at the skin care of patients with a head-neck tumor.~   "
39691|NCT03047161|"~     Fetal research and clinical practice has been hampered by a lack of suitable investigational~     techniques. Currently, ultrasound is the only widely used method of studying fetal anatomy~     and physiology, but it has significant limitations for assessment of cardiac rhythm. The~     proposed study will allow the investigators to evaluate fetal magnetocardiography (fMCG) as a~     new tool for the study of normal and abnormal fetal heart rate and rhythm.~   "
39692|NCT03047148|"~     Early post-anesthesia status of patients emerging from surgery encompasses vital respiratory~     and hemodynamic parameters as well as subjective signs of well-being such as absence of~     nausea, vomiting and a low pain level. This investigation intends to compare the rate of~     postoperative complications in the 2 groups from pair matched patient records after regional~     anesthesia with otherwise similar patients after general anesthesia.~   "
39693|NCT03047135|"~     Olaparib has demonstrated preliminary efficacy in metastatic castration-resistant prostate~     cancer. In a trial of 49 evaluable patients treated with olaparib, 11 / 49 experienced a PSA~     response, and every patient with a radiographic response also had a PSA5 response.~      Ten of 11 responders had mutations in DNA repair genes. While PARP inhibition is showing~     promise in these initial studies, reserving its use for end-stage patients may not be the~     optimal timing for olaparib therapy in some patients. In addition, PARP enzymes function in~     roles beyond DNA repair, and specifically for prostate cancer are involved transcriptional~     regulation of the androgen receptor. PARP inhibition has not been tested in earlier disease~     states for prostate cancer.~   "
39719|NCT03046797|"~     In this study, fiberoptic intubation through Boussignac valve, while ventilation of morbidly~     obese patients is maintained through the ventilator, will be studied. Researchers suggest~     that the technique will allow more time for intubation trial rather than conventional~     techniques of intubation without ventilation. the Primary outcome will be the decrease of~     desaturation events during intubation. Secondary variables will include; stress response to~     intubation, the incidence of hypercapnia, hemodynamic response to intubation, successful~     intubation, the time required to intubation and operator satisfaction.~   "
39720|NCT03046784|"~     This prospective and observational trial over 55 pregnant women (third trimester) compares~     non invasive haemodynamic monitoring using Nexfin technology and ultrasonography technic~   "
39694|NCT03047122|"~     Mammography is considered the standard imaging method for breast cancer screening, and is~     known to result in reduced mortality from breast cancer. However, the diagnostic yield of~     mammography depends particularly on breast tissue density, with sensitivity as low as 30-48%~     in dense-breast women. Ultrasound is an attractive adjunct imaging method to mammography as~     it is widely accessible, relatively inexpensive and well-tolerated by patients. The addition~     of hand-held ultrasound to mammography has been demonstrated to significantly increase breast~     cancer detection in women with dense breasts. It is however dependent on the expertise and~     skill of the operator.~      In recent years, the FDA has approved the use of the automated breast ultrasound (ABUS) for~     use in screening of women with dense breast. Unlike handheld ultrasound, the ABUS is~     relatively simple to use, necessitating less technical training, and results in higher~     reproducibility.~      The research aim is to evaluation of automated breast ultrasound (ABUS) regarding the~     detection and classification of breast lesions, compared to hand-held ultrasound, according~     to the American College of Radiology Breast Imaging-Reporting and Data System (BI-RADS)~     classification. The investigator will also evaluate parameters regarding patients' comfort,~     workflow, and duration of image interpretation.~   "
39695|NCT03047109|"~     Spinal anesthesia is widely used as the procedure of choice for cesarean delivery. In~     comparison to epidural anesthesia it is faster, easier to perform, patients are more~     comfortable, complication rates are lower, and it is more cost effective. Spinal anesthesia~     is an accepted technique in elective cesarean sections. However, hypotension, resulted from~     sympathectomy is a common problem, especially in pregnant women.~      Spinal block causes peripheral vasodilation and venous pooling, which may result in maternal~     hypotension. Maternal hypotension after spinal anesthesia for cesarean delivery, without~     prophylactic measures, has a very high incidence (80%-100%). Even though highly investigated,~     spinal induced hypotension remains a major concern, and it has been referred to as the Holy~     Grail of obstetric anesthesia. The detrimental effects of the spinal induced hypotension are~     maternal and fetal. Maternal effects are nausea, vomiting and dizziness. Hypotension results~     in reduced uterine and intervillous blood flow with potential fetal hypoxia and acidosis.~      Treatment and prevention of hypotension has been the subject of much investigation and~     controversy. Prophylactic measures include: 1) left lateral tilt, 2) fluid preload, 3)~     vasopressors,4) low dose spinal anesthesia. A 15° left lateral tilt is used routinely during~     cesarean section, to prevent aorto-caval compression, however it is not sufficient as a sole~     method. Left uterine displacement is achieved by tilting the operating table or by placing a~     wedge under the woman's hip. Aorto-caval compression also may increase the spread of spinal~     anesthesia. Among the non-pharmacological interventions studied to minimize the incidence of~     hypotension sitting the patient up for up to 7 min after CSE anesthesia for cesarean section~     reduced intraoperative ephedrine requirement without affecting the success of the spinal~     anesthetic. In contrast, sitting up for 9 min resulted in the need for rescue epidural~     anesthesia without additional benefit.~      Phenylephrine Treatment of vascular failure in shock, shock-like states, drug-induced~     hypotension or hypersensitivity; correction of paroxysmal supraventricular tachycardia;~     prolongation of spinal anesthesia; vasoconstriction in regional analgesia; maintenance of~     adequate level of BP during spinal and inhalation anesthesia. It has a number of important~     attributes for treating spinal hypotension: (i) as an alpha-adrenergic agonist, its mechanism~     of action directly addresses the decrease in systemic vascular resistance following spinal~     anesthesia;(ii) phenylephrine has a faster onset of action compared with ephedrine; (iii)~     ephedrine is associated with a ﬁve-fold increased risk of fetal acidosis; and (iv) ephedrine~     is more likely to cross the placenta and increase concentrations of lactate, glucose, and~     catecholamines in the fetal circulation compared with phenylephrine. However, phenylephrine~     used alone may be accompanied by maternal bradycardia and does not beneﬁt from widespread~     clinical experience, as does ephedrine do. Thus, phenylephrine has not yet become popular,~     particularly for prophylactic use. Clinical experience suggests that phenylephrine may be~     useful in addition to ephedrine when the latter fails to correct hypotension.~      Ephedrine sulphate is a potent sympathomimetic that stimulates both α and β receptors and has~     clinical uses related to both actions. Its peripheral actions, which it owes in part to the~     release of norepinephrine, simulate responses that are obtained when adrenergic nerves are~     stimulated. These include an increase in blood pressure, stimulation of heart muscle,~     constriction of arterioles.~   "
39696|NCT03047096|"~     The aim of present study is to to investigate whether the combined injection of HA and CS was~     superior than HA alone in the treatment of knee OA.~   "
39697|NCT03047083|"~     The purpose of this study is to retrospectively evaluate the treatment patterns and~     AML-related key healthcare resource use among AML patients, stratified by FLT3 mutation~     status, intensive chemotherapy (IC) eligibility, and relapsed or refractory (R/R) status.~   "
39698|NCT03047070|"~     Functional endoscopic sinus surgery (FESS) is a commonly performed procedure. It is known~     that bleeding during FESS can affect directly to the visibility of safe landmarks and~     surgical outcomes.~   "
39699|NCT03047057|"~     Radical cystectomy (RC) remains the gold standard for treatment of patients with muscle~     invasive bladder cancer, or recurrent high grade non-muscle invasive bladder cancer.~     Nowadays, enhanced recovery pathway is used to decrease morbidity and improve acute~     rehabilitation after RC. Postoperative ileus is the most frequent reason for prolonged~     hospital stay following cystectomy.~   "
39700|NCT03047044|"~     The postoperative pain of lumbar fusion surgery is very severe that it is necessary to use~     additional analgesics as well as a patient controlled analgesia (PCA). The most common pain~     control method of this surgery is the intravenous (IV) PCA. but, if it is relatively~     insufficient amount of narcotic analgesics ,in the case of IV PCA, may be failed to reduce~     the pain intensity effectively. Consequently, it may result in the a lot of rescue analgesics~     requirement, which leads to the adverse effects in patients who are very sensitive to~     narcotic analgesics. In addition, the patient's satisfaction to the PCA may be low compared~     with that of expected. For the recently released PCA instrument 'PAINSTOP', the investigators~     can specify the mode setting including total volume, flow rate (basal rate) per hour, bolus~     dose, and lock out time (LOT). Furthermore, this device can be set to optimize basal infusion~     (B.I), which is a new mode, so that the administered rate and amount of drug can be increased~     or decreased according to the patient's use of bolus button. Therefore, this PCA device can~     be implemented to the conventional mode, and added the function of automatically controlling~     the basal rate and administered amount of drug according to the use demand of the patient.~     However, since there are few studies related to this new mode of PCA, more research is needed~     in patients with postoperative pain.~   "
39701|NCT03047031|"~     This is an active surveillance study to monitor the real world safety of nintedanib in Indian~     patients with Idiopathic Pulmonary Fibrosis. The safety of nintedanib has been assessed in~     clinical trials. Since only 20 patients from India were enrolled in the INPULSIS trials, the~     safety data on Indian patients is limited. In this active surveillance, the safety of~     nintedanib in IPF patients will be examined in Indian real world setting~   "
39702|NCT03047018|"~     The purpose of this study is to determine if a program can help children with autism who are~     overweight. Specifically, this study will look to see if changes in a child's eating habits~     and exercise can help with weight loss. Investigators also want to see how parents feel about~     the program and if they will complete the entire program.~      Twenty children with autism spectrum disorder (ASD) who are also overweight will participate~     in this study at the Marcus Autism Center. All children who enroll will receive the The~     Changing Health in Autism through Nutrition, Getting fit and Expanding variety (CHANGE)~     program. This involves 16 sessions over six months. After the six months, participants will~     come back every month for three months for a follow up visit. Therefore the study will last a~     total of nine months.~      An optional sub-study will also be conducted where participants will provide stool samples in~     order to assess their gut microbiome. Participation in this study is optional and will in no~     way affect participation in the primary study.~   "
39703|NCT03047005|"~     This study will test the effectiveness and relative efficacy of naltrexone/bupropion~     medication as a maintenance therapy for the treatment of binge eating disorder (BED) in~     patients with obesity. This is a controlled test of whether, amongst responders to acute~     treatments, naltrexone/bupropion medication results in superior maintenance and longer-term~     outcomes compared with placebo.~   "
39704|NCT03046992|"~     YH25448 is an oral, highly potent, mutant-selective and irreversible EGFR Tyrosine-kinase~     inhibitors (TKIs) targets both the T790M mutation and activating EGFR mutations while sparing~     wild type-EGFR. YH25448 is expected to beneficial for the NSCLC patients with brain~     metastasis due to good blood brain barrier (BBB) penetration property as well as for the~     treatment of primary lung lesion and extracranial lesions. This study will be conducted to~     evaluate the safety, tolerability and efficacy of YH25448 in locally advanced or metastatic~     NSCLC patients with EGFR mutations.~   "
39705|NCT03046979|"~     The purpose of this study is to evaluate the efficacy and safety of apatinib in patients with~     advanced HCC.~   "
39706|NCT03046966|"~     This study evaluates a new approach to the instruction of pediatric residents in the skill of~     neonatal intubation. Half of the participants will receive focused simulation training and~     cognitive instruction while the other half will not. The collected data from both groups will~     be compared.~   "
39707|NCT03046953|"~     The AVAIL-T trial is a trial to find out how effective avelumab is at treating patients with~     primary T-cell lymphoma that is refratory to or has relapsed following initial treatment.~   "
39708|NCT03046940|"~     The experiment aims at investigating whether the doctor-patient communication has an~     influence on patients' willingness to take medication. Patients' attitude towards the~     medication is manipulated via a critical film sequence. Afterwards patients of the two~     experimental groups have a communication with one of the investigators of the study. Patients~     are told that the investigator is a medical doctor. The doctors either communicate in a~     patient-centered or doctor-centered style with the patient. Patients in the control group do~     not have the possibility to talk to a medical doctor. Afterwards patients are offered the~     aforementioned pill that is supposed to be a cognitive enhancer (actually placebo pill). Pill~     intake is voluntary. The investigators hypothesize that patients in the experimental group~     with the patient-centered style of communication are more likely to take the pill than~     patients in the experimental group with the doctor-centered style of communication or~     patients in the control group.~   "
39709|NCT03046927|"~     This project is designed to study the role of vitamin D supplementation on the honeymoon~     phase of type 1 diabetes in children who are on standardized insulin treatment. The results~     could lead to significant changes in the approach to the early phase of type 1 diabetes with~     a strong emphasis on prolonging the honeymoon phase by using vitamin D and maintaining these~     patients on a standardized insulin regimen. The overall goal is to reduce the long-term~     complications of type 1 diabetes.~   "
39710|NCT03046914|"~     Allopurinol-induced severe cutaneous adverse reaction (SCAR) is a rare but fatal condition.~     Previous reports have reported that HLA-B*5801 is an important genetic risk factor~     significantly associated with the development of allopurinol-induced SCAR. However, there has~     been no prospective study to prove the clinical efficacy of a HLA-B*5801 screening before~     administration of allopurinol in predicting allopurinol-induced SCAR. The purpose of this~     prospective study is to test our hypothesis that a pre-screening of HLA-B*5801 will~     significantly reduce the risk of allopurinol-induced SCAR development compared to the~     historical control.~   "
39711|NCT03046901|"~     The purpose of the study is to investigate the safety and efficacy of oral vancomycin in~     patients with recurrent Primary Sclerosing Cholangitis (PSC) after liver transplantation. The~     primary endpoint is looking at the effect of the drug on liver function tests, an important~     surrogate of PSC disease activity at 12 weeks on treatment. Secondary endpoints include a~     decrease in liver function tests at 1 year, changes in bilirubin and adverse events.~     Effective treatment at the onset of PSC recurrence may lead to decreases in disease~     progression, recurrent liver failure, and repeat liver transplantation.~   "
39712|NCT03046888|"~     Prospectively randomized study in patients with renal pelvic stones who are candidate to~     standard PCNL procedure. One to one, controlled clinical trial. Patients will be randomly~     allocated into two groups, 20 patients in each group. Group A will be scheduled to receive~     routine standard PCNL. Group B will be scheduled to receive Robot assisted pyelolethotomy.~   "
39713|NCT03046875|"~     To determine the biophysical impact of biophysical Impact of Transcutaneous Spinal Cord~     Stimulation (TSCS) within a single session. We hypothesize that subjects will demonstrate~     increased volitional muscle strength with TSCS. This will be assessed by isokinetic strength~     testing of post-injury dominant-side knee extension. Subjects will be tested in both~     Transcutaneous Spinal Cord Stimulation and sham conditions.~   "
39714|NCT03046862|"~     <Research Hypothesis> The dynamics of immune systems by cytotoxic chemotherapy and its~     changes by combination with immuno-oncology agents will be uncovered.~      The combination of Durvalumab/Tremelimumab with gemcitabine/cisplatin chemotherapy is~     feasible and efficacious in chemo-naïve biliary tract cancer.~      <Purpose of the study> To assess the effect of Durvalumab/Tremelimumab in combination with~     gemcitabine/cisplatin on response rate (RR) in chemo-naïve advanced biliary tract cancer~     patients.~   "
39715|NCT03046849|"~     The purpose of this study is to find out the proportion of patients diagnosed with Lynch~     syndrome in colorectal cacner patients meeting Chinese Lynch syndrome criteria. Besides, this~     study is aimed to analyze the clinical characteristics and germline mutation of Lynch~     syndrome in Chinese population.~   "
39716|NCT03046836|"~     Alcohol use disorders (AUD) and intimate partner aggression (IPA) frequently co-occur. There~     are significant health and economic burdens associated with AUD and co-occurring IPA, and~     little empirical data to guide treatment efforts. The neuropeptide oxytocin may help mitigate~     both AUD and IPA. However, clinical data examining oxytocin's effects on human aggression is~     scant. The proposed study is designed to address these gaps in the literature by utilizing a~     human laboratory paradigm to test the effects of oxytocin on craving and aggression among~     couples with AUD and co-occurring IPA.~   "
39717|NCT03046823|"~     The study aims to:~        1. Characterize coronary artery disease (CAD) using CT Angiography (CTA) and scaling power~          law in 100 patients with obesity~        2. Characterize cardiac remodeling using curvedness-based MRI in 100 patients with obesity~        3. Compare the differences of cardiac and vascular remodeling in patients with metabolic~          syndrome and those without~   "
39718|NCT03046810|"~     Incontinence and the skin irritation (dermatitis) associated with it are common problems.~     Treatment of dermatitis is effective, but requires effective cleaning and application of a~     barrier substance to prevent further contact between urine or feces and the skin. Water based~     cleansing with the addition of a pH balanced cleanser is more effective than standard~     abrasive cleansing with paper or a cloth, and is better tolerated by those with skin~     irritation. Zinc oxide based barriers effectively promote healing and prevent further skin~     damage. Spray forms are less cumbersome and generally preferred, but are difficult to for the~     patient to apply independently given the challenge of accessing the perineum.~      40 patients, recruited from 3 specialty pelvic floor centers and 1 assisted living center~     will be provided a device that cleans, dries, and applies zinc oxide barrier spray with each~     use of the toilet. Dermatitis will be evaluated at the beginning of the study, and at weeks~     1, 2 and 6 by medical staff using a standard scale (The Kennedy Scale).Quality of life will~     be measured using a visual analog scale derived from the quality of life in incontinence~     scale.~      The investigators hypothesize that the device will 1) effectively treat incontinence~     associated dermatitis, 2) prevent recurrence, and 3) be preferred over standard treatment.~   "
39721|NCT03046771|"~     Hypothesis: 'Transport PLUS,' a low cost, easily generalizable intervention performed by~     Emergency Medical Technicians while transporting a patient home from the hospital, can~     improve transitions of care and improve patient safety following hospitalization as measured~     by decreased rates of falls and reduced rates of return to the hospital.~   "
39723|NCT03046745|"~     This study is a multi-center, prospective cohort study which are planned to enroll the 6000~     patients who diagnosed the primary gastric cancer and 12,000 healthy normal cohort~     participants for 5 years. All participants who enrolled in this registry, the participants~     were questioned by the gastric cancer survey and the serum and tissue of these participants~     were analyzed.~      The main aim of this study is~        1. To evaluate the optimal interval of endoscopic screening for early detection of gastric~          cancer and risk factors in Korean.~        2. To evaluate the diagnostic validity of serum biomarker (combining pepsinogen, H pylori~          IgG Antibody, and TFF3) as a screening test for detection of GC in Korean.~   "
39724|NCT03046732|"~     Patients with End Stage Kidney Disease (ESKD) require Renal Replacement Therapy (RRT) in~     order to survive, be it dialysis or kidney transplantation (KT). Of the two modalities, KT~     has been associated with better quality of life (QOL) [1-3], reduced morbidity and~     mortality[4, 5], and reduced healthcare costs[6]. Studies in the US have shown that patients~     receiving tailored transplant education were more likely to complete the transplant~     evaluation [9, 14, 15]. For instance, patients receiving the Explore Transplant (ET)~     education program designed by Dr. Waterman, were more knowledgeable about KT and more likely~     to complete KT evaluation than control patients. Currently, there is a lack of standardized~     KT education in Ontario. Traditional approaches have been insufficient in providing the~     necessary education and information to enable patients to make an informed decision about~     their care. To address this issue, the study will assess the impact of kidney transplant~     related education using the Explore Transplant Ontario (ETO) education program on kidney~     transplant-related knowledge and on readiness to consider KT, readiness to consider living~     donor KT, and wait list/referral rates in patients undergoing maintenance hemodialysis.~      In order to comprehensively measure this impact, 5 variables will be explored.~        1. Readiness to consider DDKT~        2. Readiness to consider LDKT~        3. KT related knowledge in patients~        4. Proportion of patients waitlisted or undergoing KT workup at 6 and 12 months after~          administration of ETO~        5. Proportion of patients who have identified at least one potential living donor at 6 and~          12 months after administration of ETO~      The hypotheses are as follows:~        1. Readiness to consider DDKT will be higher in the intervention group compared to the~          control group at follow up.~        2. Readiness to consider LDKT will be higher in the intervention group compared to the~          control group at follow up.~        3. The KT related knowledge of the patients will be higher in the intervention group~          compared to the control group at follow up.~        4. The proportion of patients waitlisted or undergoing KT workup at 6 and 12 month after~          the KT education will be higher in the intervention group compared to the control~          group.~        5. The proportion of patients who have at least one potential living donor at 6 and 12~          month after the KT education will be higher in the intervention group compared to the~          control group.~   "
39725|NCT03046719|"~     The study aimed to investigate the effectivity of bupivacaine 0,5% as post-operative~     analgesia in intravitreal silicone evacutaion surgery~   "
39726|NCT03046706|"~     The accepted recommendation after removal of vocal cord lesion is voice rest.This~     recommendation leads to great tension among the patients, loss of working days and need to~     practice speech therapy.The investigators hypothesize that voice rest after surgery does not~     affect the quality of the patient's voice. The investigators will divide the patients into 2~     groups: the first group will be instructed for a postoperative voice rest and the second~     group will not. Later the investigators will compare the results and conclude whether voice~     rest had any significance.~   "
39727|NCT03046693|"~     Clinical trial.gov~      Brief summary :~      Non-arteritic anterior ischemic optic neuropathy (NAION) is an optic neuropathy due to acute~     or subacute ischemic event of anterior optic nerve axons retrolaminar part that was~     vascularized by posterior ciliary brevis artery. The incidence of ischemia will be followed~     by axonal edema and causing compartment syndrome and heighten the incidence of ischemic.~      In NAION, the main pathology occurs at the level of the optical nerve, the axons of retinal~     ganglion cells. Initial damage is on the optic disc ischemia resulting hypoxic injury of~     axons and manifest as disc edema. Axonal edema cause disturbances of retrograde axonal~     transport of neurotrophic factors, especially brain derived neurotrophic factor, to the~     retinal ganglion cells. This will trigger a secondary toxicity and apoptosis. In addition,~     the presence of oxidative stress, calcium influx and mitochondrial damage will also triggers~     apoptosis. After the apoptosis of retinal ganglion cells, there was a thinning of the retinal~     nerve fiber layer (RNFL) through Wallerian degeneration. Thinning of the RNFL will manifest~     as visual field defects and the decline in visual acuity in patients with chronic phase~     NAION.~      Though NAION include disease entity that has long existed, but until now, there has been no~     evidence-based study on medical or surgical procedures that is effective enough to overcome~     NAION. The main treatment is to manage the risk factor such as hypertension, dyslipidemia,~     diabetes mellitus, hypercoagulable state. In general, if the patient is in the acute phase~     (edema of optic nerve head), methylprednisolone administration may be considered, but if the~     patient is already on chronic phase (atrophy disc) which generally occurs 6-11 weeks after~     the onset, then steroids are no longer indicated. Neuroprotective agent was considered as~     treatment in NAION given primary pathology NAION is the retinal ganglion cell axons. Among~     the various neuroprotective substance, Citidine diphosphocoline (CDP-choline~     5'-diphosphocholine or Citicoline) is a therapeutic option NAION.~      Citicoline is an endogenous mononucleotide consisting of ribose, cytosine, pyrophosphate, and~     choline. Citicoline is a component intermediates in the synthesis of phospholipids in cell~     membranes, ie phosphatidylcholine. Exogenous citicoline administered orally or intravenously,~     will be split into citidine and choline. Citicoline via oral administration can be absorbed~     completely and have a similar bioavailability in the blood compared to parenteral~     administration such as intravenous. Once absorbed, citicoline will be distributed throughout~     the body and enter the blood-brain barrier and the blood retinal barrier penetrate into the~     central nervous system. If there is damage to neurons, exogenous citicoline will participate~     in the synthesis of phospholipids in the neuronal cell membrane. Some studies show that~     citicoline may have a neuroprotective effect on retinal ganglion cells and supporting~     regeneration of damaged neurons in vitro. Previous research on the citicoline effect in~     chronic phase NAION give satisfactory results. Dopaminergic neurotransmitter systems known to~     occur in vast numbers in the retina and post-retinal visual pathway. Retinal ganglion cells~     using certain subtypes of dopamine as a means of communication with the visual cortex. Rejdak~     et al in animal models showed that citicoline administration could improve and strengthen the~     dopamine transmission in the retina. Citicoline also a safe medicine, without serious adverse~     effect.~      Electroretinogram (ERG) is a tool to measure the function of the retina. ERG examination can~     measure electrical changes in the retina after light stimulus. ERG examination that can~     detect changes in the activity of retinal ganglion cell is a pattern ERG. Spectral-domain~     optical coherence tomography is a tool that can measure the thickness of retinal ganglion~     cells.~      Thinning of the RNFL will manifest as visual field defects in patients with NAION. The~     typical visual field defects of NAION is altitudinal defects associated with segmental edema~     optic nerve head.~      Based on these descriptions question arises whether the citicoline supplementation can repair~     damage to the neurons of the retina, especially the retinal ganglion cells, in NAION~     resulting in improved retinal function which can be judged from the improvement of the value~     of the amplitude of the wave of P50 and N95 in the examination pattern ERG (PERG) when~     compared with placebo ? In addition whether citicoline supplementation can increase the~     thickness of retinal ganglion cells assessed using SD-OCT? Does citicoline supplementation~     give the effect of improving visual field defects in patients with NAION?~   "
39728|NCT03046680|"~     Hypertension is a multifactorial clinical condition, it may not cause symptoms and its~     diagnosis is often delayed. And even when it is diagnosed early, some patients cannot manage~     an adequate blood pressure.~      There are several hypotheses for the non-control of blood pressure, among them the difficulty~     of lifestyle change, irregular treatment with antihypertensive drugs, non-individualized~     treatment. Studies haven shown that tools such as multiprofessional team and hypertension~     leagues are important strategies to obtain a better outcome in the hypertension treatment,~     but new approaches are still necessary. Health Coaching is an individualized form of~     follow-up, promoting better adherence, better nutrition, smoking cessation, regular physical~     exercise and regular use of drugs, thus reducing cardiovascular mortality.~   "
39729|NCT03046667|"~     The project is a randomized, 2-way, blinded parallel trial in which 56 healthy adults of both~     genders with frequent occurrence of stomach trouble.This intervention trial with 6 weeks of~     daily intake β-glucans will be carried out with a beverage containing β-glucans and a control~     beverage without β-glucans. The primary aim is to investigate whether β-glucans from barley~     has an effect on stomach and intestinal health, including stool volume and frequency.~     Microbiota, concentrations of short chain fatty acids (butyrate, propionate, acetate),~     calprotectin, and energy and fat content in feces. Furthermore, blood pressure and exhaled~     hydrogen and methane, before and after the intervention, subjective perception of~     gastrointestinal problems and digestion as well as the participants' attitudes towards~     functional foods are measured using Visual Analog Scale (VAS).~      Further, specific metabolites of β-glucans in urine (exploratory endpoint) and certain toxic~     metabolites from the microbiota using metabolite profiling (metabolomics) are also analyzed~   "
39730|NCT03046654|"~     Cervical cerclage is an obstetric intervention used in women with poor obstetric histories.~     After recruiting the participant, Trans vaginal sonography will be used to examine cervical~     length and funneling. In addition vaginal examination will be performed to evaluate the~     cervix. After placing the cerclage, the participant will be invited every 4 weeks for a~     follow up evaluation session in order to examine the cervix and cerclage position. .~   "
39731|NCT03046641|"~     Duration of exercise is an important factor among the medical guides for weight loss.~     However, there is still little knowledge about other its models in middle-aged and older men.~     The present study aimed to determine the effects of the interval training on weight loss and~     lipid profile, and to compare its efficiency with the continuous training.~   "
39732|NCT03046628|"~     The aim of this study is to test the feasibility of using polarised green laser and CMOS~     camera in order to assess the tissue perfusion of lower extremity ulcers in patients~     suffering from diabetic foot by comparing this method with the percutaneous tissue oxygen~     tension examination which is currently the gold standard examination.~   "
39733|NCT03046615|"~     For procedures involving proximity to the nerves responsible for eye movement, the need to~     monitor eye movement exists. The current solution is to place needles in the muscles~     surrounding the eye. The Investigators have invented a non-invasive electrode and software~     designed to monitor eye movements non-invasively. The electrode is placed on the skin on the~     corner of the eye and using the natural dipole of the eye, detects the horizontal and~     vertical movements of the eye. The Investigators would like to prove efficacy compared to the~     standard monitoring.~   "
39734|NCT03046602|"~     The transfer of newborn child from Intensive Care Unit to maternity is very stressfull for~     parents.This anxiety could have repercussion on parents adaptation on their new environment,~     on parent's role and also on their relaional interaction with the baby. As StJoseph hospital~     receives an important number of premature babies, the neonatology service aim to evaluate the~     real life experience of mothers during the transfer to set up improvement axes with hospital~     departments upstream.~   "
39735|NCT03046589|"~     Primary Objectives:~        1. To determine the safety and tolerability of single and multiple oral doses of DP13 in~          healthy male subjects~        2. To assess the pharmacodynamics of single and multiple ascending oral doses as well as~          dosing regimen of DP13 on suppression of serum aldosterone in healthy male subjects~      Secondary Objectives:~        1. To determine the single and multiple oral dose pharmacokinetics of DP13 in healthy male~          subjects~        2. To determine the dose-dependent pharmacodynamic selectivity of DP13 in healthy male~          subjects~   "
39736|NCT03046576|"~     Increased plasma DPP4 activity (DPP4a) could predict both subclinical and new-onset~     atherosclerosis, and our previous study has found that the DPP4a was significantly lower in~     MI patients compared with patients having chest pain or unstable angina alone, and DPP4a is~     associated with no-reflow and major bleeding events in STEMI patients during hospital stay.~     As no-reflow phenomenon and major bleeding events independently associates with a worse~     in-hospital and long-term prognosis. One may speculate that the DPP4a is associated with~     long-term follow-up adverse cardiovascular events in these patients.The hypothesis was tested~     in this study.~   "
39737|NCT03046563|"~     Experimental research design with two-group repeated-measure design. Experimental group was~     pressing the Hegu (LI 4), Zusanli (ST 36) , Tianshu(ST 25) and abdominal massage for eight~     minutes total, press once in the morning and afternoon, seven days total and two days for~     follow the trail. Control group was pressing sham ponits. Research tools to self~     semi-structured questionnaire collected data on patient's diet, activity, medication,~     defecation patterns, subjective defecation feelingauscultation bowel sounds like.~   "
39738|NCT03046550|"~     This study evaluates the safety and pharmacokinetics of NTM-1634 in healthy subjects.~   "
39739|NCT03046537|"~     Detection of metabolic state of women with polycystic ovary using NA-Nose.~   "
39740|NCT03046524|"~     Objectives:~        1. Identify the clinical characteristics of parathyroid (PTH) cancer and PTH atypical~          neoplasms~        2. Investigate if PTH carcinoma and atypical neoplasm present a biological behaviour and~          have a different impact on the health of the patients~   "
39741|NCT03046511|"~     An intraperitoneal implanted catheter is always necessary to perform Peritoneal Dialysis.~     Catheter insertion has been associated with infectious complication such as Exit Site~     Infection (ESI), Tunnel Infection and Peritonitis. The last one may lead to loss of the~     technique because the need of catheter removal. Most of international guidelines recommends~     the use of prophylactic antibiotics. Different protocols has been used, mostly intravenous~     single injection before the procedure. For the last 25 years our unit gives a single~     intraperitoneal dose of Cefazolin immediately after the catheter insertion. The aim of this~     study is compare the effect of a pre- operative IV dose os Cefazolin with a post- procedure~     intraperitoneal single dose administration of the same drug.~   "
39742|NCT03046498|"~     Integration of Diabetes Prevention Program (DPP) and Diabetes Self Management Program (DSMP)~     into WellConnect.~   "
39743|NCT03046485|"~     120 Patients with visual acuity <6/12 will be randomized to receive either usual care or~     participate in a 6-week, 2 hour 'Living with Vision Loss' program led by trained leaders. We~     hypothesize that a structured self-management low-vision rehabilitation program provides a~     greater improvement in participation in daily activities, and improves quality of life in~     vision-impaired people compared to the provision of the usual low vision rehabilitation~     services. We also plan to document barriers that prevent patients with low vision (visual~     acuity <6/12) from participating in self-management course.~   "
39744|NCT03046472|"~     Background: Life time prevalence of Low Back Pain among Children and Adolescent ranges from~     32% to 66%. This prevalence gets higher with age and among 17 years old it`s equal to~     prevalence among adults. Previous episode of Low Back pain is a predicting risk factor to the~     next one, hence we should do preventative care at a young age, even before the first attack~     occur. Poor posture was found as one of the risk factors for Low Back Pain in children.~     Adolescence with neutral posture had less prevalence of Low Back Pain then those with poor~     posture. Prolong slouch sitting was associated with Low Back Pain. Prevention education~     programs, focusing on knowledge, did not show effective change in posture behavior. Hence,~     the researchers concluded that it`s better if they focus on exercise.~      Research Goal: comparison between physical therapy treatment for good posture once a week~     versus once a month, on postural behavior, thorax curve angle and Low Back Pain.~      Research type: randomize, Interventional, blinded. Methods and Procedures Population: the~     study will include 50 children and adolescents age 10-18 years suffering from poor back~     posture, with or without Low Back Pain.~      Procedure: The study will consist of two groups: both groups will get personal meeting once a~     month and a program of exercising at home every day. Treatment group will have in addition~     group meeting once a week and control group not. The intervention program will include~     physical awareness and practice for good posture, and exercises for flexibility, strength and~     muscle endurance.~      Measurement tools:Digital Inclinometer for measuring thorax curve angle. Postural observation~     for measuring postural habits. Back pain and postural habits questionnaire for measuring~     postural knowledge and habits of participant, including demographic data. Parents'~     questionnaire for measuring parents' knowledge and ideas.~      Research hypothesis: postural behavior, thorax curve angle and Low Back Pain will get better~     in both groups but more in the treatment group.~   "
39745|NCT03046459|"~     This is an open-label, single ascending dose study to characterize the safety and PK/PD~     profile of IV BNZ132-1-40, a novel peptide inhibitor of multiple cytokines in the IL-2~     family.~   "
39746|NCT03046446|"~     This is an Open-label Study to Assess the Safety of Repeat Dose of FX006 Administered to~     Patients with Osteoarthritis of the Knee~   "
39747|NCT03046433|"~     This study is a multicenter and prospective cohort study of children diagnosed with asthma.~     Clinical symptoms and signs, quality of life, blood test, and lung function were detected~     every three months. FeNO detection, chest imaging, and induced sputum smear were detected~     when necessary. Biological samples will be collected when recruiting and finishing follow-up.~   "
39748|NCT03046420|"~     This study is exploratory in nature and seeks to describe hypertension diagnosis and~     management among patients in long-term care (LTC) facilities.~      Specifically, the primary objective is to:~      • Identify LTC patients who are diagnosed with hypertension and assess the management and~     different outcomes of proper control of BP regarding to incidence of falls, cognitive~     decline, kidney diseases, cardiovascular diseases and incidence of cerebrovascular accidents~      The secondary objectives are to:~      Describe treatment patterns of hypertension in LTC facilities~        -  Identify patients who are receiving non-pharmacological treatment and effectiveness of~          this modality of treatment.~        -  Identify different classes of drugs used to treat hypertension in patients staying at~          LTC facility~        -  Identify different drug adverse effects encountered by patients receiving medical~          treatment.~        -  Identify patients who achieved normal blood pressure according to current guidelines~   "
39750|NCT03046394|"~     One Solid Ankle Cushion Heel (SACH) and two Dynamic Elastic Response (DER) prosthetic feet~     will be tried six times in random order by the patient. The patient will be an active~     prosthetic foot user who walks several kilometers per day and was amputated at the~     trans-tibial level because of injury. Gait pattern will be rated in comparison with the~     patient's previous prosthetic foot by a physiatrist, physiotherapist, prosthetist and the~     patient. One-leg standing and 10-meter walking tests will also be performed.~   "
39751|NCT03046381|"~     Schnitzler's Syndrome (SchS) is a late-onset multifactorial autoinflammatory disease~     characterized by chronic urticarial skin lesions and a monoclonal gammopathy usually~     belonging to the immunoglobulin M (IgM) or IgG class. Symptoms associated with SchS are~     recurrent fever attacks, bone and muscle pain, arthralgia or arthritis, fatigue and~     lymphadenopathy. SchS is a rare disease with approximately 300 cases reported in the~     literature. The nature of SchS is chronic without known reports about spontaneous remissions.~     Disease onset occurs around the age of 50. About 15% of patients eventually develop a~     lymphoproliferative disorder, most often Waldenström's macroglobulinemia. The pathogenesis of~     SchS is still not well defined. Functional ex vivo studies showed excessive cytokine~     production (IL-1ß, IL-6 and IL-18) of peripheral blood monocytes (PBMCs) in SchS as compared~     to healthy controls. In addition to excessive IL-6 secretion from PBMCs IL-6 has repeatedly~     been reported to be elevated in the serum of SchS patients too. As IL-6 plays a major role in~     the development of multiple myeloma, IL-6 may also be associated with the formation of~     lymphoproliferative disorders in SchS.~      Until now, there is no approved standard therapy available for the treatment of SchS.~     Non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, and other immunosuppressive~     agents have been reported to provide variable relief from symptoms of bone pain and~     arthralgia. Case reports and small studies about successful treatment of SchS with anti-IL-1~     blockers (anakinra, rilonacept and canakinumab) accumulate. However, there have been complete~     and partial treatment failures to anti-IL-1 blockade in SchS. In these patients, anti-IL-6~     treatment (tocilizumab [TCZ]) demonstrated to be very effective in reducing the clinical~     symptoms and inflammation markers in SchS. TCZ treatment has proved to be very effective,~     well-tolerated and safe in other acquired autoinflammatory disorders, systemic juvenile~     idiopathic arthritis (sJIA) and adult-onset Still's disease that share many clinical features~     (rash, fever, joint involvement, lymphadenopathy, fatigue) and excessive cytokine production~     with SchS. The study consists of a run-in baseline period of 1-4 weeks followed by an~     open-label 20-week TCZ treatment phase with weekly s.c. injections (TCZ 162mg), followed by~     an optional study extension up to a total of 1 year with ongoing once weekly TCZ 162mg~     injections and a 4 week period of follow-up.~   "
39752|NCT03046368|"~     Several studies indicate that a survey that adapts personalized design features achieves~     higher participation rates. A feature can be a personalized cover letter which appears more~     relevant and interesting for the sample member. In the spirit of adaptive design, this study~     seeks to establish whether it can be advantageous for participation overall to use cover~     letters with targeted content and whether the effect on participation of different versions~     of the cover letter varies in sample subgroups in order to optimize design features in future~     surveys.~   "
39753|NCT03046355|"~     The goal of the study is to determine whether labor induction at 37 weeks of pregnancy can~     improve the baby's health at birth when compared with delivery at a later point in the~     pregnancy.~   "
39754|NCT03046342|"~     Comparison of clinical and laboratory diagnosis for cause of Gastroenteritis(GE) depending on~     the clinical manifestation.Identifying the sources of viral, bacterial and parasitic GE in~     Pediatric population of Qatar~   "
39755|NCT03046329|"~     The overarching objective of this study is to evaluate the symptom assessment and management~     behaviors used by multiple myeloma (MM) providers for alignment with evidence-based~     practices, and to explore changes in these symptom care behaviors from baseline to following~     use of the Carevive Care Planning System (CPS). The overarching goal of the larger program of~     research is to evaluate the impact of the platform on symptom assessment and management~     strategies with individuals receiving treatment for multiple myeloma. The current study is~     focused on determining feasibility of research methods and effect size finding so as to~     gather the requisite data needed to design fully powered hypothesis testing studies.~   "
39756|NCT03046316|"~     This is an open randomized control clinical study, which aims to investigate the overall~     benefit and safety of consolidative therapy in advanced NSCLC (stage III/IV) patients , who~     do not progress after front line systemic therapy (chemotherapy or target therapy).~   "
39757|NCT03046303|"~     This study is a prospective, single-center, randomized controlled trial. The study protocol~     was approved by the Ethics Committee at the First Hospital of Jilin University.ERAS is~     combined with the laprascopic gastrectomy to assess the efficacy and safety in patients with~     advanced gastric carcinoma.The hospitalized patients were randomly divided into ERAS group~     and conventional pathway group . Inter-group differences were evaluated for clinical recovery~     index, economic indicators, length of hospital stay, 3 years to 5 years long-term survival,~     etc.~   "
39758|NCT03046290|"~     The authors study the efficacy of the pudendal versus penile block for the relief of~     postoperative pain in children receiving ambulatory circumcision.~      In this prospective, double-blind, randomized, parallel-arm trial, 60 children recruited~     during the anesthesia consultation will be allocated a general anesthesia with a pudendal~     block (PUD group) or a penile block (PEN group).~      Each block will be made with equal parts lidocaine 1% and ropivacaine 0.75% (0.3 ml/kg).~   "
39759|NCT03046277|"~     Evaluation of acute kidney injury, renal recovery and development of chronic kidney disease~     in patients undergoing lung transplantation~   "
39760|NCT03046264|"~     There is growing evidence that central blood pressure is a better predictor of hypertensive~     end-organ damage and cardiovascular outcome than routine brachial readings.~      The investigators aimed to evaluate the accuracy of a novel device for the non-invasive~     determination of central blood pressure based on automated oscillometric radial pulse wave~     analysis.~   "
39761|NCT03046251|"~     The purpose of this study is to evaluate if monthly natalizumab, initiated after delivery, is~     effective in preventing postpartum relapses.~   "
39762|NCT03046238|"~     To Evaluate the effect of addition of Dexmedetomedine to ultrasound guided modified Pecs~     block on post operative analgesia & stress response in patient undergoing modified radical~     mastectomy.~   "
39763|NCT03046225|"~     Total knee arthroplasty (TKA) consists of a surgical replacement of this joint by a~     prosthesis, and it is mainly carried out in cases of knee osteoarthrosis. In the~     postoperative period of TKA, the pain is intense and limits the mobility of patients, so the~     analgesia is one of the goals of the physical therapy. One of the alternatives available for~     pain management is the transcutaneous electrical nerve stimulation (TENS), characterized by~     the application of an electric pulsed current through electrodes positioned on the skin.~     Therefore, the present study aims to evaluate the acute effects of TENS associated with~     conventional physical therapy compared with conventional physical therapy on the pain level,~     knee range of motion and administration of morphine in the rehabilitation of patients after~     TKA.~   "
39764|NCT03046212|"~     Transcutaneous electrical nerve stimulation (TENS) is characterized by the application of an~     electric pulsed current through electrodes positioned on the skin. It can be an alternative~     for pain management after surgery for total hip arthroplasty (THA), since it is a safe and~     cost-effective therapeutic tool, allowing the patient to move early due to pain relief.~     Therefore, the study aims to evaluate the acute effects of TENS associated with standard~     physical therapy compared with standard physical therapy on the intensity of pain, hip range~     of motion and morphine consumption in the rehabilitation of patients after THA.~   "
39765|NCT03046199|"~     Chronic obstructive pulmonary disease (COPD) is a common chronic disease with a significant~     medical and economic impact. Its prevalence is increasing and is estimated at 7.5% of people~     over 40 in France. COPD is responsible for a significant impairment of quality of life and~     was the 3rd leading cause of death in the world in 2010 when it was 4th place 20 years ago.~      However, about 75% of patients with COPD are not diagnosed. Spirometry is the only~     examination for the diagnosis of COPD. Patients identified at risk for COPD are~     insufficiently using spirometry and general practitioners (GPs) underestimate the severity of~     COPD when they do not practice spirometry in their patients. COPD is often diagnosed too~     late, the disease being discovered at the stage of complications requiring hospitalization.~     The underdiagnosis is mainly due to poor knowledge of patients, their difficulty in accessing~     a specialist performing spirometry, their reluctance to perform spirometry, and the~     insufficient involvement of general practitioners.~      Currently in France, targeted screening for COPD and diagnosis in primary care is a major~     challenge. The international (GOLD 2014) and French (HAS 2014) recommendations do not~     indicate a systematic screening in the general population for COPD but advocate targeted~     screening of patients by five questions to identify risk factors and symptoms of COPD. The~     presence of at least one of these factors in an adult over the age of 40 requires spirometry.~      Recent studies suggest the relevance of finding primary care variables for smoking and~     respiratory symptoms in order to identify new cases of COPD.~      However, the impact of the use of these questionnaires on the prevalence of diagnoses of COPD~     in general practice has not been demonstrated. Moreover, the heterogeneity of the provision~     of care according to the territories limits a fast or easy access (distance) to the~     spirometry.~      It is therefore necessary to evaluate in primary care the interest of a targeted screening of~     COPD and the interest of a coordination of care for the realization of a spirometry, in order~     to improve the rate of diagnosis of the disease.~   "
39766|NCT03046186|"~     After gastric sleeve patients undergo a substantial weight loss, but the physiological~     mechanisms behind the weight loss is not fully elucidated. Studies suggest that gut-hormone~     secretion is altered comparable to what is also seen after Roux-en-Y gastric bypass, however~     to which extent is not fully established and furthermore, the mechanisms behind an altered~     secretion are unclear. The purpose of this study is to investigate absorption and~     postprandial metabolism of glucose and protein in addition to gut hormonal responses after~     gastric sleeve compared with a group of un-operated subjects machted on sex, age and BMI.~     Furter, a group of Roux-en-Y gastric bypass operated patients matched on pre-operative BMI,~     current BMI, sex and age will be included for comparison.~   "
39767|NCT03046173|"~     To investigate the effects of concentrated growth factors applied in maxillary sinus floor~     elevation via a lateral window approach with simultaneous implant placement on repair of bone~     defects and new bone formation.~   "
39768|NCT03046160|"~     Background: Dyskinesia has been referred to as a major manifestation of affected muscle~     performance and neuromuscular control of the scapular stabilizers. Alterations around the~     scapula with muscular imbalances could facilitate or emphasize dysfunction in its surrounding~     structures through compressive and shear stresses created by abnormal pull through~     attachments. No studies have investigated the effect of scapular mobilization with movement~     on neck mobility and pain. Objective: To quantify the effects of utilizing a scapular~     mobilization with movement on cervical pain and range of motion as compared to conventional~     treatment under the presence of scapular dyskinesia. Design: an experimental case-control~     study. Setting: Dammam Medical Complex. Methods: thirty-four patients with chronic~     non-specific neck pain. Participants will be allocated to one of two groups: experimental~     group where treatment will involve conventional and manual interventions or the control group~     where treatment will consist of the conventional approach only. The manual intervention will~     consist of a sustained corrective scapular glide during neck movement in all directions.~     Measurements will include: Visual Analog Scale, pressure pain threshold, neck range of~     motion, scapular rotation measure and Neck Disability Index. Statistical analysis: all will~     be done using SPSS version 22.0 for Mac. Means and standard deviations will be given as~     descriptive statistics. Paired t-test will be used to study the effects of scapulothoracic~     mobilization and exercises on neck range of motion and pain intensity. Independent t-test~     will be used to compare the effects of the two interventions on pain intensity Key words:~     Pressure pain threshold; Scapula; Intervention, Manual therapy, mobilization.~   "
39769|NCT03046147|"~     Bone mineral density (BMD) is decreased after Roux-en-Y gastric bypass (RYGB) but whether~     RYGB induces changes in BMD beyond adaptation to major weight loss is not known. We aim to~     investigate BMD changes in weight bearing (hip, lumbal columna) and in non-weight bearing~     (forearm) regions before and after maximal weight loss at 1 year and after weight~     stabilisation at 4 years after RYGB. Moreover, plasma markers of bone turnover will be~     studied at fasting and during oral glucose tolerance test.~   "
39770|NCT03046134|"~     Chronic obstructive pulmonary disease (COPD) is one of the leading causes of morbidity and~     mortality worldwide. By 2030, COPD is expected to be the fourth main cause of death.~     Community-acquired pneumonia (CAP) represents not only a frequent complication but also a~     deadly cause in COPD patients. Inhaled corticosteroids, which are frequently used among COPD~     patients increase the risk for pneumonia. The effect of pneumococcal conjugate vaccine 13~     (PCV13) on the prevention of pneumococcal pneumonia among COPD patients in Korean population~     has not been studied yet.~      Several factors such as multi-lobar pneumonia, Pseudomonas aeruginosa pneumonia, and high~     pneumonia severity are related to poor outcome of patients with COPD and pneumonia. Prior~     pneumococcal vaccine has a beneficial effect on outcomes of pneumonia with COPD patients.~     However, the effects of pneumococcal vaccine on the clinical outcome of COPD patients were~     evaluated mainly on 23-valent pneumococcal polysaccharide vaccine (PPV23). The beneficial~     effects of PPV23 rapidly fade out after inoculation, which is more prominent in old age~     group. In this sense, PPV23 vaccine is not sufficient in preventing pneumococcal diseases in~     COPD patients because COPD is the disease of old ages and mortality rate increases~     exponentially with advancing age. Pneumococcal conjugate vaccine 13 (PCV13) can overcome the~     waning phenomenon by the production of memory B cells. Although PCV13 is expected to be the~     best option for the prevention of pneumococcal pneumonia in COPD patients, there are few~     available studies supporting it.~      In this study, we will conduct prospective, multi-center trial with the collaboration of~     Korean pulmonologists in five university-affiliated hospitals. In this study, we will~     evaluate influenza and pneumococcal vaccination status, the pathogen distribution, pneumonia~     severity, and clinical outcomes of hospitalized pneumonia patients with COPD.~      If successfully accomplished, this study will enhance the awareness of the preventive use of~     PCV13 in COPD patients among Korean pulmonologists and, most importantly, it will lead to~     protection of more COPD patients from pneumococcal pneumonia, one of the most frequent and~     deadly complication.~   "
39829|NCT03045367|"~     This study evaluates the safety and efficacy simultaneous, trans-conjunctival, 25-Gauge~     vitrectomy and phacoemulsification with intraocular lens implant in patients with~     metamorphopsia and visual impairment due to idiopathic epiretinal membrane and cataract. All~     30 patients recruited underwent complete ocular examination, visual acuity measurement with~     ETDRS, metamorphopsia assessment with M-Charts and Metamorphometry® and foveal thickness~     evaluation by sd-OCT preoperatively, at 30, 90, 180 days postoperatively.~   "
39771|NCT03046121|"~     This study will address the effectiveness of Family-centered Function Focused Care (Fam-FFC).~     Fam-FFC is a theoretically-based approach to care in which family caregivers partner with~     nurses to prevent functional decline and other complications related to hospitalization in~     older adults with Alzheimer's disease and related dementias. A systematic care pathway~     promotes information-sharing and decision-making that promotes physical activity, function,~     and cognitive stimulation during the hospitalization and immediate post-acute period. Our~     goal in this work is to establish a practical and effective way to optimize function and~     physical activity; decrease neuropsychiatric symptoms, delirium, and depression; prevent~     avoidable post-acute care dependency; and prevent unnecessary rehospitalizations and~     long-stay nursing home admissions, while mitigating family caregiver strain and burden.~   "
39772|NCT03046108|"~     The aim of this work trial is to compare the effectiveness of blind and ultrasound guided~     injection for Morton neuroma in order to determine which is more appropriate as the initial~     procedure in conservative treatment~   "
39773|NCT03046095|"~     It is well known that periods of weight training lead to increases in skeletal muscle size~     and strength. In contrast, periods of inactivity such as bed rest or immobilization result in~     losses of skeletal muscle size and strength. However, individuals experience variable~     magnitudes of muscle size change in response to changes in mechanical tension, such that~     certain individuals experience large changes in muscle mass whereas others do not. What is~     not currently known, and will be the primary goal of the present investigation, is to~     determine whether individuals who gain the most muscle mass with exercise training also lose~     the most muscle when they are immobilized. The investigators hypothesize that individuals who~     gain the most muscle with training will also lose the most with immobilization.~   "
39774|NCT03046082|"~     Observation of prescription usage of anaerobic antibiotics for patients admitted to the ICU~     with pneumonia.~   "
39775|NCT03046069|"~     Three main classes of inhaled treatment exist for chronic obstructive pulmonary disease~     (COPD): Beta2-adrenergic agonists (which may be short (SABA) or long (LABA) acting),~     long-acting muscarinic acetylcholine receptor antagonists (LAMA), and inhaled corticosteroids~     (ICS). For subjects at higher risk of exacerbation, treatment with all these three classes of~     medication is recommended. This study aims to explore the potential utility of a device~     called single inhaler triple combination or fluticasone furoate/ umeclidinium/ vilanterol~     (FF/UMEC/VI) inhaler containing all three groups of compound. This is a mixed methods study~     with a qualitative phase and a quantitative Discrete Choice Experiment (DCE) phase and will~     be conducted in four stages: qualitative concept elicitation, DCE development, DCE piloting~     and testing, and conduct of the DCE. The study will conducted in the United Kingdom (UK),~     United States (US) and Germany and approximately 573 subjects with COPD will be included.~   "
39776|NCT03046056|"~     The primary objective of this study is to evaluate the efficacy of filgotinib, when compared~     to placebo, in establishing clinical remission in participants with Crohn's disease involving~     the small bowel. Participants will have the option to enter a separate long-term extension~     study if they meet eligibility requirements.~   "
39777|NCT03046043|"~     The purpose of this study is to evaluate the efficacy of additional ablation targeting~     complex fractionated atrial electrogram area within low voltage zone identified by high~     resolution mapping in patients with persistent atrial fibrillation.~   "
39778|NCT03046030|"~     The aim of this proposal is to investigate brain response and connectivity changes evoked by~     video-guided acupuncture imagery treatment (VGAIT) and verum and sham acupuncture in healthy~     and patient populations to elucidate the underlying brain mechanisms of mind-body~     interaction, imagery, and acupuncture.~   "
39779|NCT03046017|"~     Chronic low back pain patients aged 21 to 60 needed for a research study of the effects of~     transcranial direct current stimulation (tDCS) on the analgesic effects of lidocaine cream as~     measured by functional Magnetic Resonance Imaging (fMRI). Study will be conducted on nine~     separate days not requiring an overnight stay in the hospital.~   "
39780|NCT03046004|"~     The aim of this study is to assess the effect of receiving information about the benefits and~     harms of mammography screening on informed choice, decisional conflict, intention to~     participate in the Early Detection of Breast Cancer Program (EDBCP), and satisfaction. The~     primary outcome is informed choice about breast screening (adequate knowledge, and~     consistency between attitudes and intentions). The sample of participants is composed by 400~     women from Catalonia and the Canary Islands (Spain) who will receive their first invitation~     to participate in the EDBCP of the Public Health Service in a period of 2-4 months.~   "
39781|NCT03045991|"~     The purpose of this study is to determine the treatment effects of sequential combination of~     aerobic exercise and cognitive training on cognitive function, physiological markers, daily~     function, physical function, social participation and quality of life in stroke patients with~     cognitive decline.~   "
39782|NCT03045978|"~     To study the role of ghrelin, leptin, adiponectin, neuropeptide Y (NPY), orexin A, IGF-1,~     IGFBP-1, IGFBP-3, and corticotrophin-releasing hormone (CRH) in the nutritional status in~     children with feeding difficulty, and further to evaluate their regulation with feeding~     difficulties (anorexia, picky eating behavior, feeding disorders with concurrent medical~     conditions).~   "
39783|NCT03045965|"~     HOPPSA is a register based randomized controlled trial (R-RCT), with the objective to examine~     if opportunistic salpingectomy compared with no salpingectomy, at the time of hysterectomy~     for a benign reason~        -  has no increased risk of complications~        -  has no negative side effects on ovarian function and subsequent cardiovascular disease~          or incidence of fractures~        -  implies reduced risk of subsequent ovarian cancer Randomization and follow-up will be~          conducted within national registers.~   "
39784|NCT03045952|"~     Ultrasound-guided percutaneous MWA of liver cancer is a relatively new technique with~     favorable long-term outcomes.Butthe results are mainly from single center reports.A larger~     scale data need to be analyzed to evaluate the technique. This study is designed to~     investigated the efficacy of cooled-tip microwave ablation (MWA) for primary liver cancer~     (PLC) and analyzed the prognostic factors on a multicenter database.Between January 2013 and~     December 2018, all the PLC patients underwent ultrasound-guided percutaneous cooled-tip MWA~     as a primary treatment will be enrolled from at least ten Chinese institutions with different~     levels of MWA experience. All the patients will be closely followed up until June 2019.~     Clinicopathologic data, recurrence and survival estimates, complications and~     prognosis-relative factors will be measured.~   "
39789|NCT03045887|"~     This study is the first administration of GSK2292767 to humans. The study will evaluate the~     safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and repeat~     inhaled doses of GSK2292767 in healthy smokers. This study is intended to provide sufficient~     confidence in the safety of the molecule and preliminary information on target engagement to~     allow progression to further repeat dose and proof of mechanism studies. This is a two part,~     single site, randomized, double-blind (sponsor open), placebo controlled study. Part A will~     consist of two 3-period interlocking cohorts to evaluate the safety, tolerability and~     pharmacokinetics of ascending single doses of GSK2292767 administered as a dry powder~     inhalation. Part B is planned to follow Part A and progression will be based on an acceptable~     safety, tolerability and pharmacokinetic profiles. Subjects will receive repeat doses of~     GSK2292767 once daily for 14 days during Part B.~   "
39790|NCT03045874|"~     The purpose of this study is to conduct community-engaged research (CEnR) with families and~     pediatric providers caring for the children in those families to address the following~     specific aims:~        1. Examine parents' knowledge and perceptions about their 6-36 month old children's sleep~          and objective characteristics of sleep, including (1a) self-reported and~          actigraph-recorded characteristics of sleep, sleep habits, and difficulty; (1b) the~          contributions of sleep habits and individual, family, community, cultural/social, and~          health-related factors to sleep characteristics and sleep difficulty; (1c) consequences~          of sleep difficulty; (1d) successful and unsuccessful strategies used to promote~          children's sleep and sleep habits; (1e) preferences regarding sleep promotion~          interventions for their children; and perceptions of the optimal timing to begin sleep~          promotion intervention~        2. Examine pediatric primary care providers' perceptions about (2a) the importance of sleep~          and sleep habits for 6-36 month old children; (2b) factors that contribute to sleep~          habits and sleep difficulty; (2c) successful and unsuccessful approaches to promote~          healthy sleep habits, adequate duration and good quality sleep and assessment and~          management of sleep difficulty in young children within the context of their families;~          and (2c) barriers, facilitators, and preferences regarding sleep-promoting interventions~          for families with young children;~        3. Collaborate with families and providers to use the information obtained in Aims 1 and 2~          to develop and refine a feasible, relevant, and acceptable sleep promotion program,~          including procedures, protocols, patient materials, intervention fidelity plans, and~          delivery methods.~   "
39791|NCT03045861|"~     GSK2838232 is a novel HIV-1 maturation inhibitor (MI) that is being developed for the~     treatment of HIV-1 infection in combination with other antiretroviral therapy (ART). This~     study will be a 10-day monotherapy, open-label, adaptive, dose ranging, repeat-dose study.~     This study will be conducted in two Parts (Part A and Part B) consisting single daily doses~     of GSK2838232 and Cobicistat from Day 1 to Day 10. This proof of concept open-label study~     will be aimed to characterize the acute antiviral activity, pharmacokinetics (PK), the~     relationship between PK and antiviral activity, and safety of GSK2838232/cobi administered~     across a range of doses over 10 days in HIV-1 infected patients. A cohort of 10 subjects will~     be studied in Part I followed by interim (go/no-go) analysis of Part A data. On completion of~     an interim analysis of part A data, further cohorts of 8 subjects will then be studied in~     Part B in a parallel design in two or more cohorts (depending upon the data obtained in Part~     A). Approximately 34 HIV-1 infected treatment-naive subjects will be enrolled during the~     study. Subjects in both parts will have a screening visit within 30 days prior to first dose~     and a follow-up visit 7-14 days after the last dose. Maximum duration of study participation~     will be approximately 6 Weeks.~   "
39792|NCT03045848|"~     LEADERS-FREE trial demonstrated the safety and efficacy of polymer-free drug-coated stent~     (Biofreedom, Biosensors International Technologies, Singapore) in patients with high bleeding~     risk. But, there are limited clinical evidences for extending these findings to generalized~     patients who are eligible to PCI. Therefore, the purpose of this registry is to evaluate the~     safety and efficacy of Biofreedom stent in patients with coronary artery disease.~   "
39793|NCT03045835|"~     Baska mask is a new novel supraglottic airway device with many salient features. The~     investigators aim to determine the benefit of BASKA mask as an effective airway device for~     laparoscopic surgery, and whether it can even substitute endotracheal intubation, in order to~     smoothen the surgery and anaesthesia process as well as reduce perioperative complications.~   "
39794|NCT03045822|"~     There are an increase number of patients with cardiac implantable electronic devices (CIEDs)~     such as pacemakers (PM) and implantable cardioverter-defibrillators (ICDs) worldwide. The~     current medical practice guidelines warn on performing bioimpedance analysis (BIA) in this~     group of patients to avoid any electromagnetic interference. These recommendations restrict~     the use of BIA in many patients with heart failure in whom BIA might be of great interest in~     detecting peripheral congestion and in guidance of treatment. However, it is not well known~     whether BIA can affect the function of cardiac devices. Investigators aimed to test the~     incidence of electromagnetic interference between BIA and CIEDs.~   "
39795|NCT03045809|"~     The current standard of care for urogenital infections in Rwanda is syndromic management.~     Many urogenital infections are asymptomatic and therefore completely missed, and the~     management of vaginal discharge syndrome is known to be suboptimal. The primary objective of~     this study is to evaluate whether it is feasible to improve urogenital infection care in high~     risk women in Kigali, Rwanda, using point of care (POC) diagnostic testing for HIV,~     Trichomonas vaginalis (TV), and bacterial vaginosis (BV) in all women; POC testing for~     Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT), and syphilis in pregnant women and~     women assessed to be at high risk for these infections using a risk scoring questionnaire;~     and management of vaginal candidiasis, urinary tract infection (UTI), genital ulcers/inguinal~     bubos, and lower abdominal pain in women reporting relevant symptoms. The secondary~     objectives of this study are 1) to evaluate the performance and 2) cost effectiveness of the~     POC tests for CT/NG, TV and BV; and 3) to obtain the opinions of Rwandan stakeholders.~   "
39830|NCT03045354|"~     The purpose of this study is to determine the effect of carbohydrates of familiar breakfast~     meals on glycemic response, subjective appetite, and food intake in normal weight (NW) and~     overweight or obese (OW/OB) children.~   "
39796|NCT03045796|"~     Previous research has shown that many patients with kidney failure undergoing chronic~     hemodialysis (HD) have a very low venous oxygen concentration, which may further decrease~     during dialysis treatments. This may be due to a variety of factors including anemia,~     compromised pulmonary function, and chronic fluid volume overload. Previous studies have~     shown that low venous oxygen concentrations may increase the risk of cardiovascular events,~     cognitive deficits, and mortality in HD patients.~      The purpose of this study is to identify patients with hypoxemia during HD treatments and~     characterize the extent of and implications of their hypoxemia. Specifically, the~     investigators aim to examine the relationship between central venous oxygen concentration and~     hemodynamic changes during dialysis treatment. The investigators will evaluate the~     relationship between cardiac output as measured by the Task Force Monitor and central venous~     oxygen saturation as measured by the Crit-Line Monitor and Wrist0x2 in HD patient. Data from~     this study will provide insight into potential mechanisms responsible for side effects~     associated with dialysis treatment, such as drops in blood pressure and cognitive~     dysfunction.~   "
39797|NCT03045783|"~     The purpose of the study is to evaluate the efficacy and safety of prophylactic use of~     antibiotics in endoscopic injection of tissue adhesive in gastric varices.~   "
39798|NCT03045770|"~     The aim of this study was to compare the efficacy and safety of mFOLFOX, mFOLFIRI and FOLFPTX~     as first-line treatment in AGC or EGJA.~   "
39799|NCT03045757|"~     The overall goal of this study is to describe the oral motor skills of neonates born with~     congenital heart defects, both before and after cardiac surgery, and to evaluate current~     measures of feeding motor skills and feeding readiness in this population using the Neonatal~     Oral Motor Assessment Scale (NOMAS) and the Infant Driven Feeding Scale.~      The specific aims are to:~        1. Describe the oral motor skills of infants with CHD before surgery as compared with~          normal full-term newborn (>37 weeks) using the NOMAS~        2. Describe the oral motor skills of infants with CHD after surgery as compared with those~          same infants before surgery using the NOMAS.~        3. Determine if the current Infant Driven Feeding Readiness Scale appropriately identifies~          which children with CHD are ready for oral feeding. (A. Feeding Readiness Scale, B.~          Quality of Nippling Scale at the 1st post- operative feeding evaluation)~        4. Describe the unique characteristics of oral motor skills in infants with CHD (ie. Wide~          jaw excursions, poor latch, etc.) Our hypothesis is that infants with CHD will have~          dysfunctional sucking patterns before surgical repair as compared to normal newborns.~          This dysfunctional sucking pattern in infants with CHD will have worsened post-surgery~          as compared to pre-surgery. In addition, the Infant Driven Feeding Scale will be~          utilized to predict that many infants with CHD will not be ready for oral feedings,~          however most of those patients will go on to successfully take oral feedings.~   "
39800|NCT03045744|"~     The investigators have recently shown in two pilot incomplete SCI patients that long-term~     paired associative stimulation is capable of restoring voluntary control over some paralyzed~     muscles and enhancing motor output in the weak muscles (1). In this study, the investigators~     will administer long-term paired associative stimulation to incomplete SCI patients in a~     long-term manner, keeping each patient in the study for as long as continuous improvement is~     observed.~   "
39801|NCT03045731|"~     The purpose of this study is to establish an ultrasound mathematical model using acoustic~     radiation force impulse (ARFI) and contrast-enhanced ultrasonography (CEUS) for diagnosing~     the status of renal allografts.~   "
39802|NCT03045718|"~     The objective of this study is to determine whether horticultural therapy would improve the~     psychological well-being older adults who are at risk of memory (cognitive) decline. 100~     elderly subjects who are at risk of cognitive decline will be randomized into the active~     horticultural therapy or to the waitlist control group. Sessions will be conducted weekly for~     9 months, and participants will be assessed at 3 time-points: at the start of the study, at 3~     months and at 9 months.~      It is hypothesized that participants who undergo horticultural therapy will perform better on~     neuropsychological tests when compared to control, and that they will have improved~     psychological well-being and functional outcomes.~   "
39803|NCT03045705|"~     In the current study the investigators wish to evaluate the effect the doctors and midwives~     in the delivery room have on the timing and modality of analgesia chosen by the participants.~     The participants will be randomly divided into 2 groups. Both groups will be advised of the~     different modalities of analgesia available during labor. One group will be managed in the~     delivery room the same as if not part of the study, meaning the doctors and midwives will~     treat the participants the way they usually do regarding analgesia. The second group of~     participants will not be asked by the doctors and midwives about analgesia at all but will be~     able to receive analgesia by a modality of choice at the timing of choice.~   "
39804|NCT03045692|"~     The aim of the study is to determine if colistin dosage adjustment using 4hr CrCl contribute~     to better clinical outcomes compared with drug dosage adjustment using eGFR in critical ill~     patients. In control group, colistin maintenance dosage will be decided using serum~     creatinine based eGFR (in ml/min). In study group, colistin maintenance dosage will be~     decided using 4hr CrCl.~   "
39805|NCT03045679|"~     The aim of this prospective randomized controlled trial is to compare the two procedures~     One-anastomosis gastric Bypass/Mini-gastric Bypass (OAGB/MGB) and Roux-en Y gastric bypass~     (RYGB) in relation to intraoperative and postoperative complications (classification of~     Clavien-Dindo), mortality, metabolic impact (remission of type 2 diabetes mellitus,~     hypertonus, gastro-esophageal reflux disease, sleep apnea, dyslipidemia, quality of life,~     operation time, postoperative excess weight loss, malnutrition and re-do/revisonal surgery.~   "
39806|NCT03045666|"~     48 patients, over the age of 18, with pulmonary arterial hypertension (PAH) classified as WHO~     III-IV, that are all stable under Macitentan therapy ( medication for treating PAH patients),~     will be recruited to the study through the pulmonary hypertension (PH) clinic at Soroka~     Medical Center. The patients will be randomly divided into an intervention group, which will~     exercise twice a week for 12 weeks, supervised by physiotherapists, and a control group,~     which will only receive the medication. Tests will be performed before the beginning of the~     intervention program, 6 weeks after it has begun, at the end of the 12 week program, and 3~     months after finishing the program.~   "
39807|NCT03045653|"~     Background: Endocrine therapy is an effective and safe treatment for hormone receptor~     positive breast cancer. Unfortunately , endocrine treatment resistance occurs and there is an~     urgent need for treatment alternative. Laboratory researches and clinical case reports~     indicate that hormone receptor-high expressed breast cancer patients may potentially benefit~     from high-dose Tamoxifen or high-dose Tamoxifen plus chemotherapy , providing a new option~     for treatment strategy.~      Aim: To explore the efficacy and safety of high-dose Tamoxifen to advanced hormone~     receptor-high expressed endocrine therapy resisted breast cancer.~      Methods: Eligible patients will be treated with tamoxifen 100 mg/d or high-dose Tamoxifen(100~     mg/d ) plus chemotherapy. Blood and tumor samples will be obtained from the patients.~      Primary endpoint: clinical benefit rate at 16 weeks(CBR)~   "
39808|NCT03045640|"~     Study activities were carried out to adapt and test a family-strengthening intervention to~     improve child development outcomes among families facing adversity in Rwanda.~   "
39809|NCT03045627|"~     Most of patients with acute myeloid leukemia (AML) are elder and have poor prognosis despite~     induction chemotherapy.The regimen of cytarabine(Ara-C), aclarubicin and G-CSF (CAG regimen )~     has been widely used in China for the treatment of acute myeloid leukemia (AML). Strategies~     to reduce the toxicity associated with intensive chemotherapy include the attenuated doses of~     standard regimens and myeloid growth factors. Granulocyte colony-stimulating factor(G-CSF) is~     efective in the prophylaxis and management of chemotherapy-induced neutropenia，but requires~     daily administration because of its short half-life． Pegylated granulocyte colony-stimulating~     factor (PEG-G-CSF )is a long-acting reagent that permits less frequent injection．The project~     is undertaken by Qilu Hospital of Shandong University and other well-known hospitals in~     China.In order to report the efficacy and safety of PEG-G-CSF combined with Ara-C and~     aclarubicin for the treatment of Acute Myeloid Leukemia, compared to the regimen of Ara-C,~     aclarubicin and G-CSF (CAG ).~   "
39810|NCT03045614|"~     Evaluation of the prevalence of kidney disease, hemodynamic predictors and long-term renal~     outcome in patients with pulmonary hypertension.~   "
39811|NCT03045601|"~     Invasive coronary angiography is currently considered gold standard in the assessment of~     coronary artery disease although the method has limitations. Most importantly invasive~     angiography only depicts coronary anatomy without determining its physiological significance~     i.e the likelihood that the stenosis impedes oxygen delivery to the heart muscle. Fractional~     flow reserve (FFR) is a catheterization technique for assessing the physiological~     significance of a coronary artery lesion during invasive coronary angiography. Coronary~     computed tomographic angiography (CCTA) is a noninvasive imaging test that has become an~     alternative route to diagnosis for patients with suspected coronary artery disease.~     Computational fluid dynamics combined with anatomical models based on CCTA scans allows~     determination of coronary flow and pressure, and has emerged as a promising diagnostic~     modality called CT-FFR. In this Project New Mathematical algorithms are developed for~     computation of CT-FFR. The main objective of this study is to determine the diagnostic~     accuracy of CT-FFR values obtained by the new method compared with invasive coronary~     angiography with fractional flow reserve and state-of-the-art dobutamin stress~     echocardiography.~   "
39812|NCT03045588|"~     The investigators will examine the long-term effects of a combined training and diet~     intervention that, acutely, increases fat oxidation during exercise. This is done with a 4~     week intervention study with moderately trained cyclists. Performance is tested pre and post~     intervention and muscle biopsies are obtained.~   "
39813|NCT03045575|"~     This is a prospective observational study designed to determine the feasibility and~     acceptability of objectively measuring physical activity, sedentary time, and sleep using the~     Fitbit Charge HR wristband. 50 patients who have been diagnosed with breast cancer and are~     planning to initiate chemotherapy will be invited to participate in this study, and we will~     measure general and breast-specific quality-of-life using PROMIS measures for 3-6 months~     after completion of chemotherapy.~   "
39814|NCT03045562|"~     To evaluate the influence of Salvianolate injection on myocardial microcirculation perfusion~     in subjects with STEMI who underwent primary PCI~   "
39815|NCT03045549|"~     The study was designed to compare the clinical outcomes of a home-based rehabilitation~     program using a novel digital biofeedback system against conventional home-based~     rehabilitation after total hip replacement This system allows the patients to perform~     independent rehabilitation sessions at home, under remote monitoring from the clinical team.~     The investigators hypothesise that the clinical outcomes of a home-based rehabilitation~     program will be at least similar to the outcomes of a traditional home-based rehabilitation~     with face-to-face sessions. This is a randomised controlled trial with active comparator.~     Patients will be enrolled pre-operatively and then divided into 2 groups: experimental group~     and conventional rehabilitation group. Both groups will perform an 8-week rehabilitation~     program starting between day 7 and 10 aftersurgery.~      The experimental group will perform daily exercise sessions at home using the system, under~     remote monitoring from a physical therapist. The conventional rehabilitation group will~     perform 3 home-based rehabilitation sessions per week, each with 1h duration, given by a~     physical therapist.~      Outcomes will be measured at weeks 4 and 8 and then at 3 and 6 months. The primary outcome is~     the change in patient performance measured by the Timed-up-and-Go (TUG) test between in~     comparison with the pre-operative score. Secondary outcomes will be measured in terms of: a)~     Hip Osteoarthritis Outcome Score (HOOS); b) range of motion of the hip joint (lying~     flexion/abduction; standing flexion/adbuction/hyperextension)~   "
39816|NCT03045536|"~     Several surgical options for the reconstruction of massive bone defects have been described~     and include biologic methods with autografts and allografts, and the use of tumor~     endoprostheses (total femoral replacement, TFR). Several types of modular TFR are available,~     but nevertheless unpredictable outcomes and high complication rates have been described from~     most authors. The aim of the present study was to compare complication rates after TFR~     performed with modular total femur prosthesis MML (Fa. ESKA/Orthodynamics) in patients with~     and without malignant disease.~   "
39831|NCT03045341|"~     This study will test the effectiveness and relative efficacy of behavioral and pharmacologic~     treatments, alone and in combination, for the treatment of binge eating disorder (BED) in~     patients with obesity. This is an acute treatment comparing behavioral weight loss alone or~     in combination with naltrexone/bupropion medication.~   "
39817|NCT03045523|"~     This clinical study is a phase IIa, multi-center, randomized, double-blind,~     placebo-controlled, parallel group study to evaluate two doses of orally administered~     GLPG2222 in adult subjects with a confirmed diagnosis of CF harbouring one F508del CFTR~     mutation and a second gating (class III) mutation and on stable treatment with ivacaftor.~      Up to 35 evaluable subjects are planned to be included in the study. Eligible subjects must~     be on stable treatment with physician prescribed ivacaftor (Kalydeco®) for at least 28 days~     at the baseline visit. They will be randomized in a 2:2:1 ratio to receive one of two active~     doses of GLPG2222 (150 mg q.d. or 300 mg q.d.) or placebo q.d. administered for 29 days.~     Subjects will be in the study for a minimum of 6 weeks and a maximum of 10 weeks, from~     screening until the follow-up visit.~   "
39818|NCT03045510|"~     Myelodysplastic syndrome (MDS) is widely recognized as a clonal hematopoietic stem cell~     disorder. Decitabine has been approved for the treatment of all subtypes of myelodysplastic~     syndrome (MDS). However, the use of decitabine is often limited by its severe toxicity~     represented by myelosuppression even at relatively low doses. In lower-risk patients~     (including IPSS low and int-1 risk groups), treatment mainly aims at improving cytopenias,~     especially anemia. However, although several drugs may improve anemia, sometimes durably,~     most of lower risk MDS eventually require red blood cell (RBC) transfusions during their~     disease course. Long term RBC transfusions lead to iron overload mainly due to an increase in~     reticulo-endothelial iron recycling.Cardiac, liver and endocrine (diabetes mellitus)~     dysfunction due to iron overload and often leading to fatal outcome has been reported in~     heavily transfused lower risk MDS patients.~      To date, the optimal regimen for decitabine treatment is not well established. In this study,~     we perform a prospective analysis to explore the decitabine schedule for the treatment of~     lower risk myelodysplastic syndrome patients with transfusion dependent.~   "
39819|NCT03045497|"~     This pilot clinical trial compares the use of contrast-enhanced ultrasound to~     contrast-enhanced magnetic response imaging (MRI), the current clinical standard, in~     predicting treatment response in patients with liver cancer receiving transarterial~     chemoembolization with drug eluting beads. Comparing results of diagnostic procedures before~     and after transarterial chemoembolization may help doctors predict a patient's response to~     treatment and help plan the best treatment. It is not yet known if contrast-enhanced~     ultrasound works better than contrast-enhanced MRI in predicting treatment response in~     patients with liver cancer.~   "
39820|NCT03045484|"~     Background:Although concurrent chemoradiotherapy is effective for improving disease-free~     survival and overall survival in patients with locally advanced nasopharyngeal carcinoma.~     However,the oral mucositis pain evoked by the chemoradiotherapy itself reduces food intake~     and frequently halts the treatment. Thus, pain control is an important problem in~     chemoradiotherapy for nasopharyngeal carcinoma.We performed to examine whether early~     induction of low-dose, opioid from moderate pain reduced total dose of Oxycodone during~     chemoradiotherapy, while improves the quality of life and reduce weight loss.~      Objective:Present clinical trial to investigate the early introduction of opioids suppressed~     the transient increase in the numeric rating scales(NRS) score for pain and compared with~     conventional treatment.~      Methodology:The subjects will recruit 70 patients who were hospitalized for nasopharyngeal~     carcinoma. 70 patients were divided into two groups, depending on whether the pain was~     moderate or severe when an opioid was introduced.Differences between groups were compared~     using T test protected least significant difference for one-factor analysis of variance. All~     statistical analyses were performed using SPSS(Statistic Package for Social Science)~     software.P-values < 0.05 were considered statistically significant.~   "
39821|NCT03045471|"~     1. Compare the efficacy of R-EPOCH and R-CHOP regimen for patients with AIDS associated CD20+~     diffuse large B lymphoma; 2. Compare the safety of R-EPOCH and R-CHOP regimen for patients~     with AIDS associated CD20+ diffuse large B lymphoma.~   "
39822|NCT03045458|"~     The present study was compared the level of alveolar bone loss, clinical parameters and IL-1β~     in PICF in one- or two-stage surgical procedures. Half of the patients were performed tissue~     level implant while other half were performed bone level implant.~   "
39823|NCT03045445|"~     Hypothesis: double low-dose protocol provide better lesion conspicuity than standard protocol~     CT in patients at high-risk of HCC.~      patients who are scheduled for CECT for HCC diagnosis or surveillance are eligible for this~     study and allocated to either standard protocol or double-low dose protocol using spectral CT~     with low radiation dose and low dose of contrast media, within clinically accpetable range.~   "
39824|NCT03045432|"~     Several factors associated with the hemiplegic shoulder pain after stroke includes rotator~     cuff injury, bicipital tendonitis, impingement, spasticity, limited external rotation of~     shoulder joint, adhesive capsulitis, shoulder subluxation, shoulder hand syndrome, and~     brachial/axillary neuropathy. In this study, the investigators aim to usie high frequency~     ultrasound to evaluate the relationship between stroke patients with poor shoulder motor~     function and shoulder tendon injury. Also, assumed that performing passive range of motion~     and positioning training might prevent tendon injury of shoulder and hemiplegic shoulder pain~     in either acute or chronic stage of stroke.~   "
39825|NCT03045419|"~     It would be valuable to evaluate whether gadoxetic acid-enhanced liver MRI would provide~     additional value for characterizing atypical or small (1~2cm) hepatic nodules at CT and to~     reduce the necessity of biopsy in patients with high risk of HCC.~      Therefore, the purpose of this study is to evaluate added value of gadoxetic acid-enhanced~     MRI for diagnosis of HCC in patients with small (10-19mm) or atypical hepatic nodules at CT.~   "
39826|NCT03045406|"~     Apixaban for the treatment of venous thromboembolism in patients with cancer: a prospective~     randomized open blinded end-point (PROBE) study~   "
39827|NCT03045393|"~     The main purpose of this study is to determine how 2 doses mirvetuximab soravtansine affects~     the amount and activity of folate receptor alpha proteins in tumor cells of patients who have~     completed standard neoadjuvant treatment and are scheduled to have their tumors surgically~     removed.~   "
39828|NCT03045380|"~     The study was designed to investigate the effect of video games based physical activity~     training on upper extremity functions, walking, balance and cognitive functions in persons~     with multiple sclerosis (MS). For this aim, the participants with MS will be divided into~     three groups: game based physical activity training, conventional rehabilitation, and no~     intervention groups. The experimental groups will receive therapy sessions once a week for 8~     weeks. The no intervention group will receive no intervention, they will be assessed at~     baseline and after 8 weeks.~   "
39835|NCT03045289|"~     This research will examine the feasibility of conducting a strict whole-food, plant-based~     dietary intervention in women with stable metastatic breast cancer currently undergoing~     conventional treatments. In addition, this research will provide preliminary data on dietary~     intakes and the effect of plant-based nutrition on numerous outcomes reflecting cancer~     prognosis and overall health using advanced imaging, various blood biomarkers linked to~     cancer progression, and numerous symptom questionnaires.~   "
39836|NCT03045276|"~     The purpose of this study is to determine the effectiveness of behavioral feedback plus~     economic incentives to promote treatment adherence among a large diverse population of~     adolescents and young adults (AYA) with kidney transplant (KT) or spina bifida (SB).~   "
39837|NCT03045263|"~     The purpose of this study is to evaluate the application of a modified version of PRT~     designed specifically as a parent-training model via telemedicine, with the goal of~     increasing access to empirically validated care. The project will feature an 18-week trial of~     parent training PRT via telemedicine in 12 cognitively able 3- to 6-year-old children with~     ASD. Intervention will focus on enhancing the following developmental skills: expressive and~     receptive language, play, and social interaction. Outcome measures will address changes in~     the aforementioned domains during structured observation and standardized assessment.~   "
39838|NCT03045250|"~     Assessing the use of corneal confocal microscopy to evaluate for early neuropathy changes in~     subjects with Type 1 Diabetes.~   "
39839|NCT03045237|"~     Healthy Bellies is an intervention program with pregnant women, based on the promotion of~     healthy lifestyles. It aims to evaluate the impact of the program in the health of both~     pregnant and newborn. This trial is being conducted with pregnant women, divided into control~     and intervention group. Are performed 3 assessment periods: 1 - beginning of the program; 2 -~     postpartum; 3 - 1 month after delivery. The intervention group has a program of 3 weekly~     physical exercise classes and the control group has the basic information that is usually~     provided by health professionals. With this program, it is expected to contribute with~     evidence to the best practice in the field of interventions in pregnancy and improve health~     outcomes of both pregnant and newborn.~   "
39840|NCT03045224|"~     The PTA-Registry (PTA-REG) is a prospective health services research registry to monitor and~     follow-up patients with peripheral arterial disease undergoing endovascular peripheral~     intervention. The PTA-REG has an interdisciplinary approach: cardiologists, angiologists, and~     radiologists contributed actively to this registry.~   "
39841|NCT03045211|"~     When postural imbalance and gait difficulties emerge in subjects with Parkinson disease,~     patients are typically referred for a number of physical therapy sessions. However, there is~     a critical gap in clinical practice on what to do once patients have completed their therapy~     sessions. To fill this gap, the study team has developed a standing table with a tabletop~     system that encourages weight shifting during upright standing (dynamic standing table),~     and therefore may be a unique means to increase daily physical activity by integrating the~     system with routine desktop activities of daily living. The purpose of this study is to~     determine whether a post-physical therapy in-home physical activity program using the dynamic~     standing table (as an adjunct to post-physical therapy standard of care—weekly physical~     activity group sessions) is effective in sustaining the mobility benefits of physical therapy~     in individuals with Parkinson disease.~   "
39842|NCT03045198|"~     In collaboration with Dr.Birgit Alteheld, Institute of Nutrional Sciences of the university~     of Bonn, Germany the following effect is explored: Effect of a 4 week therapy with AZT on~     synthesis of lipoproteins as well as Docosahexaen and other fatty acids in patients with~     Cystic Fibrosis (CF). Moreover proinflammatory cytokines in blood and sputum are of interest.~   "
39843|NCT03045185|"~     Aim: The aim of this prospective study was to evaluate the treatment outcomes of regenerative~     endodontic technique (RET) for the management of traumatised non-vital immature teeth in~     children. Methodology: This study aims to recruit 25-30 healthy children with traumatised~     non-vital immature upper incisors to be treated with bi-antibiotic regenerative endodontic~     technique. Patients will be reviewed clinically at 3m,6m,9m,12m,2y,and 3 years and~     radiographically at 3m,9m, 2y,and 3 years. One operator will undertake all treatments,~     clinical reviews and standardised radiographic exposures. Radiographic analysis will be~     carried out by two calibrated experienced clinicians. Standardised photographs will be taken~     at 3m,12m,2y,and 3 years and crown colour changes will be assessed using a standardised~     validated methodology.~   "
39844|NCT03045172|"~     Lichen sclerosus (LS) is a skin condition of the external genitals (vulva) of women. LS~     causes vulvar itching, pain, and burning. In addition, LS causes scarring of the vulva which~     may cause significant sexual dysfunction or pain. Lastly, 4-6% of women with LS will develop~     vulvar cancer.~      The current gold standard treatment for lichen sclerosus is potent steroids creams. When~     used correctly, steroid creams help to decrease the symptoms of itching and burning and can~     prevent further vulvar scarring. In addition, proper treatment reverses the underlying~     inflammation of LS, and may lower the risk of getting cancer. While useful, steroid creams~     may have serious side effects that include thinning of the skin, fungal infections, and~     lowering the immune system.~      Platelet-rich plasma (PRP) is a platelet concentrate that helps to speed up tissue healing,~     without serious side effects, in a very wide range of medical conditions such as diabetic~     foot ulcers, muscle injury, tendon injury, and in a variety of cosmetic procedures. The PRP~     works because of its high level of proteins that help with wound healing. It is also apparent~     from the majority of published studies that PRP therapy has minimal risk of scar tissue~     formation or significant bad side effects.~      Recently, there was an exploratory study of twelve subjects that used PRP for the study~     treatment of lichen sclerosus. While this study showed good success, the study was limited~     because of its small size and lack of placebo (a drug or study treatment that contains no~     active ingredient) control.~   "
39845|NCT03045159|"~     The purpose of this research is to evaluate the efficacy of the Strong Families Strong Forces~     Parenting Program compared to a parental self-care (Strong Parents) condition in a sample of~     150 Active Duty Families with children ages birth to 5 years.~   "
39846|NCT03045146|"~     FRench Acute cerebral multimodal imaging to select patient for MEchanical thrombectomy is a~     prospective multi-center study to determine if multimodal imaging could identify patients who~     may and those who may not benefit from an endovascular clot removal procedure within 6 hours~     after stroke onset.~   "
39847|NCT03045133|"~     Introduction. Despite the advantages associated with the use of remifentanil during total~     intravenous anesthesia (TIVA), it has been observed a frequent difficulty in the control of~     postoperative pain due to the risk of developing hyperalgesia and acute tolerance associated~     with the administration of this opioid. There is evidence that NMDA receptors are involved in~     the development of these changes. Methadone is an opioid that exhibits analgesic potency~     similar to that of morphine but has NMDA antagonist activity and longer duration of action as~     additional features. The objective of the study was to evaluate the quality of recovery~     (QoR40) of patients undergoing TIVA for laparoscopic cholecystectomy and who received~     morphine or methadone to control postoperative pain. Methods. Patients aged 18 to 65 years,~     physical status ASA I and II, submitted to total venous anesthesia (propofol and~     remifentanil) for laparoscopic cholecystectomy and eligible to participate in this~     prospective and randomized clinical study will be evaluated. After induction of anesthesia,~     patients will receive a solution containing 0.1 mg.kg-1 morphine (MF group) or 0.1 mg.kg-1~     methadone (MT group). Data on the presence of pain, nausea, vomiting, tremor, drowsiness,~     presence of SpO2 <92%, even with O2 face mask (5 L.min-1) and length of stay will be recorded~     at PACU. The pain will be evaluated every 15 minutes on a verbal numerical scale (ENV) from 0~     to 10. E.v. morphine 0.1 mg.kg-1 (MF group) or methadone 0.1 mg.kg-1 (MT group) will be~     administered every 15 minutes to obtain the score below 3. After discharge from the PACU, all~     patients will receive intravenous ketoprofen every 12 hours and dipyrone every 6 hours. For~     cases where the patient considers the analgesic regimen insufficient, tramadol (100 mg) will~     be administered intravenously at 8-hour intervals. The consumption of analgesics, the~     intensity of pain, the occurrence of nausea, vomiting and other complications in the ward~     will be recorded. The application of the questionnaire (QoR40) will be performed in the ward~     the morning after the surgery by a medical student.~   "
39848|NCT03045120|"~     This non-interventional, prospective study will characterize the impact of three approved~     first and second generation BCR-ABL1 tyrosine kinase inhibitors on cardiovascular and~     metabolic risk factors in chronic phase CML (CP-CML) patients who are TKI naive and~     initiating first-line TKIs in routine clinical practice in the US. All treatment decisions~     will be determined at the discretion of the treating physician(s) and data identifying the~     cardiovascular and metabolic risk factors will be collected. Additional fasting blood samples~     (collected following 8 hours of fasting) will be collected during standard of care~     (SOC)/routine office visits. Additional research imaging will be performed and will be~     reviewed by core imaging laboratory. As the study is collecting data on management of CML,~     this study will not influence the prescribing or management practices at participating sites.~   "
39849|NCT03045107|"~     During the last few years, the laparoscopic right colectomy with intracorporeal ileocolic~     anastomosis (IIA) has been proposed as an alternative to laparoscopic right colectomy with~     extracorporeal ileocolic anastomosis (EIA) for the treatment of right colon tumors. However,~     the level of evidence coming from the currently available literature is low, based on the~     results of a few small and heterogeneous retrospective non-randomized studies. A randomised~     controlled trial is warranted to challenge these two procedures. The aim of this randomized~     controlled trial is to assess the outcomes after IIA or EIA after laparoscopic right~     colectomy for right colon tumors.~   "
39850|NCT03045094|"~     This study evaluates the effect of head and neck movement in children on endotracheal tube~     (ETT) tip displacement undergoing head-and-neck surgeries. The tube-tip displacement will be~     measured using flexible fiberoptic bronchoscope.~   "
39851|NCT03045081|"~     To develop and test a web-based patient empowerment platform, PainTracker Self-Manager~     (PTSM), that can support integrated multimodal care in a variety of specialty and primary~     care settings. The investigators will adapt PainTracker, a web-based outcome and treatment~     tracking tool already deployed in multiple University of Washington clinics to create the~     PTSM self-management tool that helps assess, engage, activate, and support patients' efforts~     to self-manage their chronic pain in collaboration with their clinicians. PTSM design will be~     based on 4-phase patient engagement strategy derived from Acceptance and Commitment Therapy.~     Phase 1 focuses on achieving consensus on the clinical problem definition, treatment goals~     and timeline. Phase 2 focuses on promoting values-based action and acceptance of pain. Phase~     3 focuses on providing skills in chronic pain self-management with close monitoring of~     patient reported outcomes and actigraphy. Phase 4 focuses on providing autonomy support to~     promote maintenance of self-management behaviors. Phase 5 involves generating a patient~     registry with the above data for use in quality improvement research. The investigators will~     engage patients, providers and investigators in designing PTSM, reviewing prototypes, and~     conducting usability testing. In a 6-month clinical trial, the investigators will compare 50~     intervention patients from the UW Center for Pain Relief who receive PTSM to 50 historical~     control patients who have received the basic PainTracker. The primary outcome will be chronic~     pain self-efficacy, with secondary outcomes of: chronic pain acceptance, perceived efficacy~     in physician-patient interactions, and patient and provider satisfaction. Development of the~     PTSM platform will support the dissemination of the multimodal interdisciplinary care for~     chronic pain that is recommended in the National Pain Strategy, and may help chronic pain~     care meet the goals of the Triple Aim: better patient experience, better patient outcomes,~     with lower costs.~   "
39852|NCT03045068|"~     Hypothesis:~      Dilutional thrombocytopenia after cardiopulmonary bypass (CPB) is universal and~     administration of donor apheresis platelets just prior to termination of bypass will assist~     in early correction of coagulopathy, early hemostasis and lesser donor exposure of blood~     products after cardiac surgery.~      Background:~      What is the Problem? - Bleeding, Transfusion and Outcomes~        1. Excessive bleeding after neonatal cardiac surgery has been independently associated with~          increased adverse events, morbidity and mortality.1,2 Bleeding after neonatal open-heart~          surgery has multiple etiologies such as immaturity of the building blocks of~          coagulation, effects of deep hypothermia, longer CPB times, altered flow states and~          dilutional state induced by being on CPB leading to low platelet count, low platelet~          function, low fibrinogen levels, altered fibrinogen polymerization, complement~          activation, etc.2,3 The strongest predictor of transfusion after cardiopulmonary bypass~          in children was deemed to be the CPB circuit volume and the effect of hemodilution.4~        2. The dilutional coagulopathy after neonatal CPB requires intense damage control~          resuscitation with massive transfusion of platelets, packed red blood cells (PRBC),~          cryoprecipitate, fresh frozen plasma (FFP) and supplemental factor concentrates. In a~          previous study at this institution (IRB# HSC-MS-13-0647), we have shown that in neonates~          undergoing open-heart surgery there was a significant drop in platelet counts after~          bypass (71% change, baseline= 268 ± 90, Post CPB= 76 ± 27, 109/L). Associated with this~          drop , the average intraoperative transfusion load in neonates undergoing cardiac~          surgery with CPB at our institution constitutes of PRBC= 63± 43 ml/kg, FFP=51± 21 ml/kg,~          cryoprecipitate =12+6 ml/kg, platelets = 28 +16 ml/kg and cell-saver =27± 10 ml/kg. In~          addition 72% of these patients were exposed to a 3-factor prothrombin complex~          concentrate (Bebulin®). Although this throw the kitchen sink approach is effective in~          achieving hemostasis, it comes with significant effects on post CPB hemodynamics,~          constantly changing hematocrit, variable blood volume with inability to achieve steady~          state inotropic state affecting cardiac output, oxygen delivery and adding to pulmonary~          hypertension.~      Overall, having higher platelet counts at the time of weaning from cardiopulmonary bypass has~     distinct advantages of reducing transfusions and improving outcomes.~   "
39865|NCT03044899|"~     STUDY OBJECTIVE To confirm the incidence of in-hospital postoperative complications in adult~     surgical patients in Africa.~      STUDY DESIGN Seven day, African national multi-centre prospective observational cohort study~     of adult (≥18 years) patients undergoing surgery. Patients will be followed up for a maximum~     of 30 days. We will follow the original International Surgical Outcomes Study (ISOS) study~     design.~      The primary outcome is in-hospital postoperative complications in adult surgical patients in~     Africa. Secondary outcomes include in-hospital mortality and the relationship between~     postoperative complications and postoperative mortality.~      The intention is to present a representative sample of surgical outcomes across all African~     countries. This study will run between February and March 2016.~   "
39866|NCT03044886|"~     The object of the study was to evaluate the direct effect of high dose vitamin D~     supplementation on chronic periodontitis, and suggest the recommended dose for clinic use.~   "
39853|NCT03045055|"~     Ischemic stroke, which is due to the occlusion of a cerebral blood vessel, comprises nearly~     90% of all strokes. Currently, reperfusion of the salvageable tissue via thrombolytic drug or~     endovascular treatment is the most effective strategy to reduce brain damage. However, after~     recanalizing the occluded vessels, subsequent reperfusion injury is inevitable. It may not~     only weaken the therapeutic effects of timely reperfusion but also impede patients' recovery.~     Moreover, thousands of neuroprotective drugs effective in experimental models have been~     proved to be unsuccessful in clinical trials. Therefore, effective strategies are urgently~     needed to prevent and treat cerebral reperfusion injury and further improve the prognosis of~     acute ischemic stroke.~      Researchers applied remote ischemic conditioning to mouse model of focal cerebral reperfusion~     injury and found that it could reduce cerebral infarct size. And clinical researches~     demonstrated that remote ischemic conditioning was an effective strategy to improve cerebral~     perfusion and prevent recurrent stroke in patients with ischemic stroke. However, whether~     remote ischemic conditioning is safe and effective in protecting patients with large-vessel~     ischemic stroke and undergoing endovascular treatment is still unclear. The investigators'~     hypothesis is that RIC is a safe and effective strategy to reduce brain injuries in stroke~     patients undergoing endovascular treatment.~   "
39854|NCT03045042|"~     This study aims to analyze serum and plasma samples from patients with late onset Pompe~     disease treated and not treated with enzyme replacement therapy (ERT) to identify microRNA~     that could be specific of the disease. The investigators will correlate the concentration of~     these microRNA with several muscle function tests and quantitative muscle MRI to know whether~     they are good biomarkers of progression.~   "
39855|NCT03045029|"~     This is a prospective, observational, multicenter, patient registry to observe and assess the~     real-world use and tolerability of Orenitram (treprostinil). Patients who are newly initiated~     on Orenitram for the treatment of pulmonary arterial hypertension (PAH) or who transition~     from another prostacyclin therapy will be evaluated for 52 weeks to observe dosing regimens,~     titration schedules, prostacyclin-related adverse events (AEs), and clinical outcomes of~     interest.~   "
39856|NCT03045016|"~     After a traumatic event such as an accident or an assault, victims may experience intense~     stress symptoms that may evolve into post-traumatic stress disorder (PTSD). It is a~     frequent and serious pathology, which can be complicated by depression, addiction or suicide.~     Few means are available to prevent PTSD in people who have just undergone trauma. Prazosin is~     an antihypertensive drug that blocks α1 adrenaline receptors which could help to stop the~     vicious circle of stress and prevent the development of the disease. The objective of this~     study is to demonstrate the efficacy of prazosin to prevent PTSD in patients who visit an~     emergency department after trauma.~   "
39857|NCT03045003|"~     The aim of this phase II study is to test by feasibility and efficacy of two~     interprofessional supportive care interventions with different intensities to facilitate~     resilience in patients and thereby to reduce their unmet supportive care needs.~   "
39858|NCT03044990|"~     Several epidemiologic studies reported that patients with renal insufficiency might have~     increased cardiovascular disease-related mortality rates after Percutaneous coronary~     intervention (PCI) . The increased risk in this population may be related to the less use of~     standard guideline-based treatment and the resulting inability to perform PCI effectively.~     Recently, with the technology improvement and the progress in clinical trials, Chinese~     guidelines have made new recommendations about the patients with acute coronary syndrome(ACS)~     in different states of renal function. However, scant epidemiologic information exists on the~     prognosis of those patients, especially in Henan. And there is still some uncertainty whether~     those patients are using the latest guideline recommended treatment.~      This multicenter, prospective, observational study is aimed to evaluate the long prognosis in~     patients with acute coronary syndrome complicated with renal insufficiency, and to analysis~     its related factors that influence the outcomes.~   "
39859|NCT03044977|"~     This study is designed to identify the best tolerated doses of [131]Iodine-MIBG and~     [90]Yttrium-DOTATOC when co-administered to treat midgut neuroendocrine tumors. These drugs~     (131I-MIBG, 90Y-DOTATOC) are radioactive drugs, known as radionuclide therapy. Currently, the~     safest and best tolerated doses of these drugs (when combined together) is unknown.~   "
39860|NCT03044964|"~     The post-marketing study is designed to evaluate the activity level and exercise tolerance of~     patients with deferred percutaneous intervention due to FFR (fractional flow reserve) greater~     or equal to 0.81 and treatment with Ranolazine versus placebo.~   "
39861|NCT03044951|"~     It's a multi-center, prospective, randomized, controlled clinical trial of cryoballoon versus~     radiofrequency ablation for paroxysmal atrial fibrillation.~   "
39862|NCT03044938|"~     Contextualization: Exercise is a common triggers of bronchospasm in patients with asthma and~     healthy subjects. To prevent these symptoms frequently they have to use Short-Acting~     Beta2-Agonists. However, the cardiovascular effects of salbutamol during and after exercise~     remain poorly known.~      Objective: To evaluate the effect of salbutamol on heart rate and blood pressure during~     exercise in patients with moderate or severe asthma and healthy individuals.~      Methods: A randomized, double-blind, crossover study will be conducted which 13 individuals~     with moderate or severe persistent asthma and 13 healthy individuals aged between 20 to 59~     years.~      Patients will perform a maximal effort test on 2 nonconsecutive days, with either 400mcg~     Salbutamol or 4 placebo puffs. The order of use of placebo or salbutamol will be drawn.~     During the protocol, heart rate, blood pressure, perception of exertion and peak expiratory~     flow will be monitored.~   "
39863|NCT03044925|"~     Compare the safety and efficacy of remote magnetic navigation-guided ablation and~     cryoablation for patients with persistent atrial fibrillation.~   "
39864|NCT03044912|"~     Recent phase III trials have confirmed the efficacy and safety of mirabegron in the treatment~     of overactive bladder (OAB) in Europeans, Australians, North Americans, Japanese and Asians.~     Whether mirabegron 25mg or 50mg should be used as the first line treatment for OAB has not~     been determined yet. The dose effectiveness relationship between 25mg and 50mg mirabegron has~     also not been investigated yet. Hence, investigators have conducted this post marketing study~     in order to evaluate the efficacy and safety between mirabegron 25mg and 50mg in Taiwanese~     people with symptoms of OAB.~   "
39867|NCT03044873|"~     The study is to assess the effect of coadministration of multiple doses of BMS-986165 on the~     systemic exposure of rosuvastatin in healthy participants.~   "
39870|NCT03044834|"~     Pleuropulmonary blastoma is a rare embryonic malignant tumour that remains the most frequent~     malignant tumour of the lung in childhood. The International Pleuro pulmonary Blastoma~     Registry (IPPB) found only 220 cases in 2009 and 350 in 2015. In France, 20 cases were~     identified in 2009.~      Three histologies are described: type 1 purely cystic, type 2 combined and type 3 solid.~     Median age at diagnostic is 12 months, 35 months and 41 months respectively. Evolution is~     possible from type 1 to type 2 or 3 in 10% of the cases.~      Since 2009, DICER 1 mutations research is proposed systematically to all families.~      PPB symptoms are usually non-specific. Diagnostic is evoked when imaging work up shows~     bubbles or solid lesions, and confirmed by pathological analysis. However the diagnosis can~     be difficult because of the proximity with congenital cystic adenomatoid malformation.~      The French society of paediatric oncology recommends surgery at first instance. PPB type 1~     remains a problem because some are still misdiagnosed as CCAM, a benign lesion. Chemotherapy~     depends on the PPB type and the quality of the resection. There is a real interest to analyse~     the French series.~      The prognosis of type 2 and 3 is low with a 5 years survival rate of 45-60%, whereas type 1~     survival rate is 91%. The French experience reports a 100% survival rate in type 1 and 48% in~     type 2 and 3. Other prognostic factors are initial size of the tumour, extra pulmonary~     invasion and quality of surgery.~      Early local relapses are possible and late ones concern more often type 2 and 3 with more~     cerebral metastasis.~      In 2009, the french cases were collected, but no update has been performed since. The aim of~     this retrospective review of the cases since 2000, is to audit the care of PPB patients in~     France and update the French rare tumour database.~      Evoking PPB diagnosis is difficult when imaging shows a neonatal cystic lesion. There are no~     radiologic criteria in the literature that differentiate congenital pulmonary cystic lesion~     and PPB type 1. Radiological presentation is however overlapping. Another aim of this study~     will be to look for a predictive sign of type 1 PPB.~   "
39871|NCT03044821|"~     Spina bifida is a neurological abnormality characterized by an opening in the skin and~     exposure of the spinal cord on the back of the baby at the time of birth. The complete~     closure and separation of the spinal cord from the skin occurs in the first month of~     pregnancy.~      This form of spina bifida is associated with leg weakness, sensation loss, and bowel and~     bladder incontinence. The majority of patients (>80%) also develop increased fluid in the~     brain, called hydrocephalus, and require additional surgery to treat this problem. Standard~     treatment of myelomeningocele (MMC) involves closing the opening in the back within the first~     3 days of life. The surgery releases the spinal cord from the skin and brings the skin edges~     together to prevent infection and injury to the exposed nerves. Of note, this type of surgery~     does not improve function.~      The investigators want to study the open in-utero fetal surgery technique in patients who are~     candidates for the standard open fetal repair technique but have a pre-pregnancy BMI of~     35.0-40.0. The latter is a reason for exclusion for open fetal repair in most centers in the~     United States.~   "
39872|NCT03044808|"~     Single center double blind randomised controlled trial. 60 subjects. Giving lidocaine IV or~     saline to patients due to robot assisted colorectal surgery. Primary outcome is cumulative~     morphine consumption at 24 hours.~   "
39873|NCT03044795|"~     In tumors with a defect in the homologous recombination (HR) pathway, double-strand break~     repair is partly impaired. Patients with HR deficient tumors benefit from therapies that~     induce DNA lesions requiring HR for repair. These therapies include platinum compounds and~     inhibitors of the enzyme PARP-1. At this moment, selection for PARP inhibitor treatment~     relies on detection of germ-line or somatic mutations in the HR pathway genes BRCA1 or BRCA2.~     However, not all HR deficient tumors have a BRCA gene mutation, the BRCA genes can also be~     silenced by promoter methylation. Moreover, the HR pathway can be defective due to mutations~     in other HR genes. In addition, the presence of a BRCA gene mutation does not guarantee~     defective HR since mutations in other genes (e.g. TP53BP1) can restore HR despite the~     presence of a BRCA1 mutation. Since all patients with tumors that are HR deficient may~     benefit from PARP inhibition, better tools are required to identify these patients. Recently,~     a functional ex vivo test for HR deficiency (the RAD51 assay) became available for clinical~     use. The RAD51 assay can identify patients with functional defects in HR-repair and may~     predict which cancer patients are likely to benefit from PARP inhibition. The purpose of this~     study is to investigate whether the RAD51 assay can select patients who will benefit from~     treatment with the PARP-inhibitor veliparib.~   "
39874|NCT03044782|"~     The purpose of the current project is twofold; first to determine what personal, historical,~     logistical, and environmental factors preclude women from obtaining medical care for CCCA~     hair loss. Because damage from CCCA is irreversible, early identification and treatment is~     paramount to limiting the negative ramifications of the disease. Second, to investigate how~     CCCA hair loss, a common occurrence in the Black population, can be a significant~     psychological impediment to lives of affected Black women. Based on previous research on the~     psychosocial impact of generalized hair loss in Black women, it is fair to consider that CCCA~     hair loss also leads to problems with self-esteem and participation in daily life activities.~     This research, the first of its kind, will add to existing knowledge of CCCA by investigating~     the quality of life and barriers to care of patients with this condition. The goal of this~     study is to illuminate what stands in the way of secondary and tertiary prevention of CCCA~     patients and tailor treatment strategies to address their needs. The results of this study~     will be instrumental in modifying dermatology resident training, adding to existing~     dermatology management guidelines, and even developing public health advocacy programming.~   "
39875|NCT03044769|"~     Congenital lung anomalies include different pathologies such as congenital cystic adenomatoid~     malformation, pulmonary sequestration, bronchial atresia, emphysema, bronchogenic cyst. They~     concern less than 1/10000 births and their physiopathological origin is still poorly~     understood. The main goal of this project is to pool the cases from different swiss centers~     on a prospective cohort study, first to increase knowledge of clinical and radiological~     evolution and their correlation with histological data, and second to analyse the~     pathological embryological mechanism underlying these malformations.~   "
39876|NCT03044756|"~     Omitting the GnRH antagonist on the day of the trigger can be cost effective and more~     convenient to the women. We will study the impact of omitting the antagonist dose in a~     prospective randomized trial~   "
39877|NCT03044743|"~     This study will evaluate the safety of PD-1 knockout EBV-CTL cells in treating EBV~     (Epstein-Barr virus) positive advanced stage malignancies. Blood samples will also be~     collected for research purposes.~   "
39893|NCT03044535|"~     The purpose of this study is to develop a measurement system to assess adjustment to~     mechanical circulatory support (MCS) (also referred to as a ventricular assist device [VAD])~     and health-related quality of life (HRQOL) in patients with advanced heart failure who~     receive a VAD. This investigators refer to this measurement system as Mechanical Circulatory~     Support: Adjustment and Quality of Life (MCS A-QOL).~   "
39878|NCT03044730|"~     The purpose of this study is to see whether a combination of two different drugs -~     pembrolizumab and capecitabine - is safe, and if it might be effective in treating triple~     negative and hormone-refractory breast cancer. Pembrolizumab is a type of drug that contains~     an antibody. Antibodies are the part of your immune system that finds things that don't~     belong in your body, such as bacteria or viruses. The antibody in pembrolizumab finds and~     blocks a protein, which allows your immune system to target and destroy cancer cells.~     Pembrolizumab is Food and Drug Administration (FDA) approved for other types of cancer. It is~     not approved for breast cancer, meaning that it is an experimental or investigational~     treatment. Capecitabine is a type of chemotherapy pill that is a standard treatment and~     FDA-approved for breast cancer. It stops the cancer cells from being able to multiply.~   "
39879|NCT03044717|"~     The purpose of this research study is to assess comfort of cardiology fellows and faculty~     with nutrition and its role in cardiovascular disease and to determine if increasing~     education in this arena will change clinical practice.~   "
39880|NCT03044704|"~     The study is a prospective-observational, explorative single-centre cohort study aimed to~     examine the influence of hemodynamic and geometric parameters on the progression of~     atherosclerotic alterations in peripheral vessels (carotids, femoral artery). Atherosclerotic~     alterations (IMT, plaque volume) will be measured with a ultrasound (IMT measurements and 3D~     quantitative plaque volumetry) and magnetic resonance imaging (MRI). Geometric parameters~     (e.g. carotid/femoral bifurcation angle, carotid/femoral bifurcation area) are assessed with~     magnetic resonance imaging (MRI) and also 3D ultrasonography.~      A total of 100 patients with an asymmetrical plaque distribution in carotid and femoral~     arteries will be tested. Only patients who are already enrolled in the Correlation of~     Artherosclerotic Plaque Volume and Intima Media Thickness With Soluble P-selectin~     (NCT01895725) and who are tested prior for an asymmetrical plaque distribution will be~     included in this study. MRI will be performed once whereas ultrasound imaging will be be~     repeated once per year (up to five times) to assess changes in these parameters over time.~     Also plasma samples will be collected once yearly and tested for traditional and novel~     cardiovascular risk factors.~      The primary endpoint of the planned study will be the correlation between geometrical and~     hemodynamic parameters as stated above and the progression of atherosclerosis as measured by~     plaque volume and IMT in the carotid and femoral arteries, respectively.~      Secondary endpoints will include the correlation of geometrical and hemodynamic parameters~     with established (hypertension, smoking, diabetes, dyslipidemia) and novel risk factors~     (hsCRP, P-selectin, cholesteryl ester transfer protein (CETP), intercellular adhesion~     molecule-1 (ICAM-1), CETP TaqIb polymorphism), with cardiovascular event rate, plaque~     localization, plaque morphology and the additional predictive value of geometrical parameters~     compared to an established risk score (SCORE card).~   "
39881|NCT03044691|"~     The primary purpose of our study is to conduct a pilot, practice-based intervention focused~     on increasing adherence to the 6As for youth ages 11 through 17 years. The 6As are: (1)~     Anticipate (future use), (2) Ask (about tobacco use), (3) Advise (advise the patient to~     quit using tobacco), (4) Assess (the patient's readiness to quit using tobacco), (5)~     Assist (by setting a quit date, providing materials on quitting tobacco, providing tobacco~     cessation medications, and referring the patient for additional services and/or counseling) ,~     and (6) Arrange (by re-contacting the patient after their quit date and arranging a~     follow-up visit).~   "
39882|NCT03044678|"~     This study was designed to conceptualize a school-based prevention program or childhood~     anxiety.~   "
39883|NCT03044665|"~     The clinical efficacy of LDL-lowering therapy have been proven with strong evidences and more~     emphasized. However, there are also growing concerns that high-intensity statin would be~     related to increased risk of adverse effects. In addition, there was an inconsistency of~     efficacy of statin according to ethnic population. Asian population showed more profound LDL~     reduction not only from high potent statin but from moderate to low potent statin.~     Conventional strategies for lowering LDL-cholesterol was focused on statins, therefore~     doubling of previously described dose of statin would be common way in patients with~     inadequate lowering LDL-cholesterol level. Additive ezetimibe will also an alternative~     strategy not only to lower LDL-cholesterol level and also to reduce the need of dosage of~     high-intensity statin to fulfill sufficient LDL-cholesterol lowering effect. We will evaluate~     whether additive ezetimibe with rosuvastatin will have comparable clinical efficacy in terms~     of clinical outcomes and goal attainment of LDL-C compared to rosuvastatin monotherapy.~   "
39884|NCT03044652|"~     The aim of the study is to gain further experience with regard to the performance of the~     medical device WO2085 Moisturising Cream in comparison to a cream with 0.1% estriol.~   "
39885|NCT03044639|"~     The randomized, double-blind, multi-centric study performed in four parallel groups to~     compare all lipid emulsions, which can be used as a part of PN. Patients with home parenteral~     nutrition due to stable intestinal failure, were randomly assigned to receive parenteral~     nutrition with one the following lipid emulsions:~        -  Long-chained triglycerides (LCT group)~        -  Medium/ long-chained triglycerides MCT/LCT (50:50, MCT/LCT group))~        -  Olive oil/ LCT (80:20, OO group))~        -  SMOFlipid (Omega-3/ olive oil/ MCT/ LCT, SMOF group)~   "
39886|NCT03044626|"~     AIO-YMO/TRK-0415 (FORCE) is a Phase 2, open-label of nivolumab, patients with metastatic~     non-squamous NSCLC with the necessity of radiotherapy of a metastatic site (e.g. bone) in~     2nd-line or 3rd-line treatment for study group A and patients with metastatic non-squamous~     NSCLC without the necessity of radiotherapy in 2nd-line or 3rd-line treatment for study Group~     B.~   "
39887|NCT03044613|"~     Anti-PD-1 (nivolumab) or Anti-PD-1/CTLA-4 (ipilimumab) administration in the pre-operative~     setting and nivolumab combined with chemoradiation will be safe and feasible in patients with~     resectable distal esophageal/gastroesophageal junction cancer and will change cellular and~     molecular characteristics of the tumor microenvironment that will improve survival.~   "
39888|NCT03044600|"~     Objectives:~        1. To better define the differences in molecular genetics of parathyroid tumors in patients~          with MEN1, single gland parathyroid disease in patients less than 50 years old and~          single gland disease in patients greater than 50 years old.~        2. To better define the incidence of HRPT2 mutation in young patients with primary~          hyperparathyroidism and determine whether routine testing in these patients is~          indicated.~   "
39889|NCT03044587|"~     AIO-YMO/HEP-0315 (NIFE) is an open label, non-comparative, randomized, multicenter phase II~     trial~   "
39890|NCT03044574|"~     The aim of the study is to evaluate efficacy and safety of VTE prophylaxis by the combination~     of graduated compression stockings (GCS), standard doses of low-molecular-weight heparins~     (LMWH) and sequential compression device (SCD) in the mixed group of surgical patients at~     high and extremely high risk for venous thromboembolism.~   "
39891|NCT03044561|"~     The aim of this study is to evaluate the effect of sildenafil citrate on endometrial~     development in women with history of recurrent implantation failure after IVF~   "
39896|NCT03044496|"~     Peripheral regional anesthesia induces a sympathectomy-like effect with neurovascular changes~     causing increased arterial blood flow and venodilatation .~      Near-infrared spectroscopy (NIRS) can be applied to different kinds of tissue providing~     oxygen saturation by detecting the absorption and reflection of near-infrared light .~      The effect on peripheral tissue oxygenation in patients undergoing arteriovenous fistula~     revision has not yet been examined. We postulate an increase in tissue oxygenation by~     sympathicolysis caused by peripheral regional anesthesia that might be the reason for~     beneficial outcome. The aim of our study was to demonstrate the effect of a supraclavicular~     plexus block in this group of patients.~   "
39897|NCT03044483|"~     When infection strikes, the body's immune system reacts by producing chemicals in the~     bloodstream and changes in white blood cells to attack the infecting organism (bacteria,~     viruses or other organisms) and prevent it spreading. This is termed the 'inflammatory~     response'. Though beneficial in fighting infection, this response can sometimes be excessive,~     causing harmful effects on body organs. This is termed the 'systemic inflammatory response~     syndrome' and when linked to infection is termed 'sepsis'.~      Previous research has shown that in patients who have sepsis, the small blood vessels~     supplying oxygen and nutrients to muscles and other organs (the microcirculation) become~     abnormal and do not function as they would in health. However, it is difficult to assess the~     function of microcirculation in clinical practice, and we want to find new, easier ways of~     doing so.~      The aim of this study is to test a new method for assessing the function of these small blood~     vessels, by directly visualising them using a highly sensitive microscope, the size of a pen,~     placed under the tongue. By understanding the flow of blood in these vessels in healthy~     individuals, we will gain a better understanding of how these vessels are affected in~     illness.~   "
39898|NCT03044470|"~     AIM : To determine the efficacy of cold saline irrigation in reduction of post operative pain~     following root canal therapy.~      METHODOLOGY : Forty patients requiring root canal treatment on permanent single rooted teeth~     were included. The patients were assigned randomly into two groups of 20 patients each. The~     teeth in Group1 (n = 20) were irrigated using normal saline solution, whilst those in Group 2~     (n = 20) were irrigated with cold saline solution stored at 4 degrees centigrade. A Heft~     Parker visual analog scale was used to measure pre-operative pain and post-obturation pain at~     12, 24,48 and 72 hours after obturation. Chi square tests and Mann Whitney U tests were used~     for statistical analysis.~   "
39899|NCT03044457|"~     A new operation technique was established (reversed gap technique for implantation of total~     knee arthroplasties. Based on the encouraging results of a pilot study, the clinical outcome~     shall be evaluated using the conventional gap technique as control in a RCT study.~   "
39900|NCT03044444|"~     In this study, the effect of citrus extract on exercise performance will be investigated. The~     study consists of three groups: one group will receive a high dose citrus extract, one group~     will receive a low dose citrus extract and the last group will receive a placebo. After four~     and eight weeks the effects on performance are measured through a Triple Wingate cycling~     test, handgrip strength, vertical jump and 1600m run trial. It is expected that exercise~     performance will increase in the citrus extract groups, compared to the placebo group.~   "
39901|NCT03044431|"~     The purpose of the Lung Institute is to collect and isolate a patient's own cells and~     platelet rich plasma (PRP) and deliver the product back to the patient the same day. Lung~     Institute's treatment is limited to self-funded patients with chronic lung disease- chronic~     obstructive pulmonary disease (COPD) and restrictive lung diseases such as pulmonary fibrosis~     (PF) and interstitial lung disease (ILD). The patient's cells and platelet rich plasma are~     harvested through venous or bone marrow collection techniques.~      The hypothesized outcomes of therapy are safety and minimization of adverse events, a~     perceived improvement in the patient's lung condition (to be determined by their perceived~     quality of life), an improvement in the FEV1 among COPD patients, the ability to reduce~     supplemental oxygen use, the ability to function well without the use of rescue inhalers,~     reduction of secondary pulmonary infections, reduction in emergency room visits and~     exacerbations related to their disease.~   "
39902|NCT03044418|"~     The study examines the special endotracheal laser tube during anesthesia of endolaryngeal~     laser surgery.~   "
39903|NCT03044405|"~     The aims of the study are:~        1. To evaluate the feasibility of echocardiography monitoring in postoperative unit;~        2. To assess diagnostic value of different focussed echocardiography parameters to define~          fluid responsiveness for non-cardiac hypotensive spontaneously breathing patients after~          major abdominal surgery.~   "
39904|NCT03044392|"~     The current standard of practice for the maintenance of epidural analgesia is through use of~     a continuous infusion pump. Enhanced technology now supports the use of programmed~     intermittent bolus (PIEB) administration. This novel drug delivery system provides small~     boluses of local anesthetic and opioid at programmed intervals. Several studies suggest that~     administration of PIEB allows a more extensive spread of local anesthetic in the epidural~     space and provides superior labour analgesia compared to traditional continuous epidural~     infusions. PIEB is associated with lower anesthetic consumption, a shorter second stage of~     labour and greater patient satisfaction.~      The authors are focusing on a PIEB setting known as the Next Bolus. Next Bolus (NB)~     determines when the first PIEB bolus is given after the initiation of the epidural and~     starting the PIEB pump. Currently we set this to be 15-45 minutes. In an attempt to optimize~     resources, authors hope to determine the optimal NB interval that will provide adequate~     analgesia but limit overall drug consumption. An optimally timed next bolus should minimize~     drug costs and limit nurse and physician intervention by decreasing the need for manual~     boluses.Increased local anesthetic consumption can cause undesirable side effects such as~     itchiness, decreased blood pressure and motor blockade. By assigning patients to receive the~     NB at 15, 30 or 45 minutes the authors hope to find the interval that provides analgesia~     while minimizing side effects, improving patient safety. If the bolus is given too late then~     there may be increased pain, less patient satisfaction, and the need for more analgesia in~     the form of Patient Controlled Epidural Anesthesia or a manual bolus.The authors hope that~     determining the NB will result in an institutional change to improve patient outcomes and~     facilitate knowledge transfer. This information will be the first available research to help~     guide other obstetrical centres using PIEB technology in determining the optimal NB interval.~   "
39905|NCT03044379|"~     Dapivirine Gel Rectal Safety and PK Study~   "
39906|NCT03044366|"~     Anesthesia management of preterm infants is challenging for the anesthesiologist. Because of~     rudimentary build, many medical and physical problems have shown in treatment of disease such~     as complications, airway problems, temperature disregulation and deficient drug metabolism.~     This retrospective study evaluates the perioperative management and postoperative course in~     premature infants undergoing diode laser photocoagulation (DLP) for retinopathy of~     prematurity (ROP).~   "
39907|NCT03044353|"~     The study is intended to evaluate whether monthly repeated courses of administration of~     GSK2315698 followed by GSK2398852 is associated with a reduction in cardiac amyloid load in~     patients with cardiac amyloidosis, monitored by cardiac magnetic resonance imaging (CMR) and~     echocardiography (ECHO), and whether this is associated with an improvement in cardiac~     function. Cohort 1 is transthyretin cardiomyopathy (ATTR-CM) , cohort 2 is patients with~     immunoglobulin light chain (AL) systemic amyloidosis at greater than 6 months post~     chemotherapy, cohort 3 newly diagnosed AL systemic amyloidosis undergoing chemotherapy.~     Primary objectives for the study are assessment of reduction in cardiac amyloid load after~     repeated administrations of Anti-SAP treatment as evaluated by CMR in all study groups and~     assessment of safety & tolerability of repeated administration of Anti-SAP treatment,~     including compatibility with chemotherapy treatment in patients with AL systemic amyloidosis.~     This is an open label, non-randomised, three-group, monthly repeat Anti-SAP treatment study~     in systemic amyloidosis patients with cardiac dysfunction caused by cardiac amyloidosis.~     Subjects will receive up to 6 courses of Anti-SAP treatment. Maximum total duration for a~     subject in the study is approximately 18 months.~   "
39908|NCT03044340|"~     Erythromelalgy (EM) is a vascular syndrome very rare affecting the feet. This disease evolve~     by crisis when the feet extremities become red hot and painful. There are several types of EM~     but this study concern the adult primitive form. For a long time, the physiopathology was not~     described but now we know that there is a vascular form, with microcirculatory dysfunction~     and a neurologic form with small fibers neuropathy. The diagnostic of neurologic form is~     based on clinical evaluation (DN4 questionnaire, UENS scale...) and an electromyography.~     Thermotest, a medical device which measure the thermic sensitivity is used to quantify~     neuropathy. More recently Sudoscan, a device measuring cutaneous impedance to chloride ions~     detect small nervous fiber in diabetic patients with good correlation with Thermotest.~      The purpose of this study is to analyze the vascular side and the neurologic side on patients~     consulting for Erythromelalgy.~   "
39909|NCT03044327|"~     The aim of this study is to further profile and develop the Lipopolysaccharide, endotoxin~     (LPS) challenge models (both by instillation and inhalation) by investigating the utility of~     various non-invasive monitoring methods.~   "
39910|NCT03044314|"~     This study will compare the clinical efficacy of inhaled iloprost as an invasive, selective~     vasodilator in the cardiac catheterization laboratory in patients with pulmonary hypertension~     to the gold standard of inhaled nitric oxide. It will also examine whether echocardiographic~     estimates of response to inhaled iloprost can predict responsiveness to invasive vasodilator~     testing in patients with pulmonary hypertension.~   "
39911|NCT03044301|"~     The aim of this study is to evaluate the performance of the ZENEO needle free device in~     subcutaneous functioning limits (low performance limit and high performance limit) and for~     intramuscular injections.~   "
39912|NCT03044288|"~     The study investigates the impact real output has on peristomal skin covered by a newly~     developed adhesive and a standard adhesive~   "
39913|NCT03044275|"~     The study investigates the impact real output has on peristomal skin covered by a newly~     developed adhesive with topfilm and a standard adhesive with a topfilm.~   "
39914|NCT03044262|"~     The study investigates the impact real output has on peristomal skin covered by a newly~     developed adhesive and a standard adhesive~   "
39915|NCT03044249|"~     A ten-week study to assess MP-101 in Dementia-Related Psychosis and/or Agitation and~     Aggression~   "
39916|NCT03044236|"~     To examine and compare the effect of a novel stretching technique and traditional stretching~     on glenohumeral range of motion, strength, maximum voluntary contraction, pain, and subject~     satisfaction in overhead athletes with glenohumeral internal rotation deficits through a~     randomized clinical study.~   "
39917|NCT03044223|"~     The present study focuses on patients with Pseudomonas aeruginosa (PSA) sepsis. The aim of~     the present study is to find out whether the M1 (pro-inflammatory) or M2 (anti-inflammatory)~     phenotype predominates in blood monocytes in critically ill patients with PSA-sepsis, and~     whether the severity of sepsis and outcome is associated with distinct monocyte phenotype and~     function.~   "
39918|NCT03044210|"~     Cockayne syndrome (CS) is related to defective DNA transcription and/or repair and belongs to~     the family of Nucleotide Excision Repair. It is an autosomal recessive multisystemic disorder~     characterized by mental retardation, microcephaly, severe growth failure with lipoatrophia,~     sensorial impairment, cutaneous photosensitivity, dental decay, enophtalmios. The disease is~     progressive causing severe impairments but there's currently no therapeutics for the disease.~      Growth failure, feeding difficulties and lipoatrophia are prognostic keys of CS but~     physiopathology is unknown.~      According to preliminary assays, our goal is to test the hypothesis that cachexia is due to~     hypometabolism. We also want to test the potential link between this basal metabolism~     modification and mitochondrial dysfunction and somatotrope axis, and correlation between the~     basal metabolism degree and global severity of the disease.~   "
39919|NCT03044197|"~     Prostate biopsies are currently the gold standard for the diagnosis of prostate cancer. Many~     biopsies, however, are unnecessary or cannot detect significant prostate cancer (PCa). With~     multi-parametric magnetic resonance imaging (mpMRI) we now potentially have a way of~     increasing the detection of detecting clinically significant prostate cancer (csPCa) while~     decreasing the detection of non-significant PCa.~   "
39920|NCT03044184|"~     This study aims to explore the effectiveness of tranexamic acid (also known as trans amine or~     TXA) in reducing hematoma expansion in patients with hemorrhagic stroke when given in the~     acute phase.~      METHODOLOGY~      This will be a Phase III, parallel-group double-blind randomised placebo control trial.~     Patients allocated to the control group will receive standard care for hemorrhagic stroke~     according to the 2015 American Heart Association guidelines. Patients allocated to the~     intervention group will receive, in addition to standard care, a loading dose of intravenous~     TXA 1gm within 3 hours of symptom onset followed by a 1gm maintenance dose over 8 hours.~     Timing and dosing are in accordance to previous established study protocols. Patients in the~     intervention group will only receive a single treatment course of TXA.~      Study subjects will be identified by either the on-duty clinicians from the Department of~     Neurosurgery of this institution or by the study investigators. Should the patient meet study~     eligibility criteria consent will be obtained either from the patient or from his/her next of~     kin. 1:1 block randomization will be performed by a remote internet randomization service by~     accessing a website. Patients allocated to the intervention arm will have 1gm of TXA added to~     100ml of normal saline (0.9%) infused over 10 minutes as a loading dose. This is then~     followed by a maintenance dose of 1gm of TXA in 500ml of intravenous isotonic solution~     infused at 120mg/hour (60ml/hour) for 8 hours. Patient's allocated to the control arm will~     have an equal volume of normal saline (0.9%) infused as a placebo. The patient and the~     outcome assessor will be blinded to study group allocation.~      The primary endpoint of this study will be to assess the percentage change in brain blood~     clot volume by computed tomography brain scans on admission, 6 hours later, at 24 hours and~     at 1 week.~   "
39922|NCT03044158|"~     The study proposes to conduct a pragmatic, parallel cluster-randomized trial with nested~     mixed methods, health economic and modeling studies to evaluate the effectiveness,~     implementation and costs of the intervention strategy relative to standard TB diagnostic~     evaluation at community health centers that are part of Xpert referral networks in Uganda.~     The effectiveness of the intervention strategy will be assessed using routine data collected~     as part of mandatory reporting to the Uganda NTLP on consecutive patients who present to~     participating health centers during the 2-year trial period and meet eligibility criteria.~     Selected patients and providers who provide informed consent will also be surveyed,~     interviewed, and/or participate in focus groups to identify reasons for its success or~     failure across study sites (Aim 2), and to collect relevant cost data for cost-effectiveness~     analyses (Aim 3).~   "
39923|NCT03044145|"~     This study consists of two projects:~      Project 1: The study team will create and refine the CFI-EA by enrolling 3 clinicians and~     9-12 patients to test the CFI-EA's feasibility and acceptability from patient and clinician~     feedback in a pre-pilot trial. The study team will first train clinicians in the CFI-EA by~     reading over the CFI-EA treatment manual and practicing how they can use it in behavioral~     simulations, and then check whether participants think they can do it (feasibility) and like~     it (acceptability) through standard measures. Following this the study team will revise the~     CFI-EA based on their feedback for the comparative open trial in Phase 2.~      Project 2: The study team will test the revised CFI-EA against treatment as usual in a pilot~     trial. 3 clinicians and 12-15 patients will be enrolled in each arm. As before, the study~     team will first train clinicians in the revised CFI-EA by reading over the CFI-EA treatment~     manual and practicing how they can use it in behavioral simulations. Then, the study team~     will check whether participants think they can do it (feasibility) and like it~     (acceptability) through standard measures, and in addition will also explore any initial~     effects on communication behaviors among patients and clinicians and treatment engagement~     based on treatment retention.~      The specific aims are:~      For Project 1:~        1. To pretest the CFI-EA intervention in a mental health setting through a pre-pilot open~          trial that explores communication mechanisms of action in terms of communication~          behavior and cultural content, and~        2. To revise the CFI-EA intervention based on patient and clinician feedback on its~          feasibility and acceptability.~      As real-world community stakeholders for whom the CFI-EA is being developed, patients and~     clinicians can provide helpful perspectives on how the CFI-EA can help clinicians tailor~     treatment plans around patient cultural views and treatment preferences to keep patients in~     care. The CFI-EA will be revised around areas of maximal agreement among patients and~     clinicians with the help of health disparities and communication experts.~      For Project 2:~        1. To test the revised CFI-EA's feasibility and acceptability among patients and clinicians~          in a pilot open trial against treatment as usual, and~        2. To explore the relationship between the revised CFI-EA's effects on patient-clinician~          communication and treatment engagement.~      The study team hypothesize that clinicians using the revised CFI-EA will show more positive~     communication behaviors compared to clinicians delivering treatment as usual and that CFI-EA~     patients will stay in treatment longer. Communication behaviors will be assessed through~     communication analysis techniques such as the Roter Interaction Analysis System.~   "
39924|NCT03044132|"~     This is a prospective, multicenter, clinical research trial evaluating the clinical outcomes~     of DermACELL AWM in dermal regeneration.~   "
39925|NCT03044119|"~     The Primary Objectives of the present study are :~        -  To Evaluate the effect of platelet rich fibrin matrix (PRFM) and peripheral blood~          mesenchymal stem cells (PBMSCs) on implant stability.~        -  To Compare the effect of platelet rich fibrin matrix (PRFM) alone to peripheral blood~          mesenchymal stem cells (PBMSCs) embedded in platelet rich fibrin matrix (PRFM) on~          implant stability.~   "
39926|NCT03044106|"~     Purpose: To conduct a pilot study of the effect of Cranial Laser Reflex Technique (CLRT)~     compared with sham laser on hamstring muscle flexibility, strength, and pain pressure~     threshold.~      Participants: Active, young adults ages 18 to 35.~      Procedures: In a single, blinded crossover fashion, subjects will complete three functional~     hamstring tests after CLRT and after sham laser treatment. Subjects will also complete~     questionnaires to assess their expectations and perceptions of the interventions.~   "
39927|NCT03044093|"~     Mifepristone and Misoprostol Compared With Misoprostol Alone for Second Trimester Abortion -~     a Double Blinded Randomized Controlled Trial~   "
39928|NCT03044080|"~     Clinical randomized clinical trial to assess the effectiveness on walking speed of repeated~     use of botulinum neurotoxin type A (BoNT/A)in the post-stroke spastic equinovarus foot in~     three successive infiltrations at 6-month intervals, checking if the sustainability of the~     effect is greater in incobotulinumtoxin A (Xeomin®) than in onabotulinumtoxinA (Botox®).~   "
39929|NCT03044067|"~     Fibromyalgia is one of the main causes of chronic musculoskeletal widespread pain. This~     condition presents a global prevalence of 2.7%, and it is more prevalent in women (with a~     female to male ratio of 3:1) over 50 years of age with low education level and low~     socioeconomic status, living in rural areas. High direct medical costs and significant~     indirect costs of this condition can't be ignored.~   "
39930|NCT03044054|"~     This study evaluates the efficacy and the safety of the HIFU for the treatment of breast~     fibroadenoma.~   "
39931|NCT03044041|"~     The purpose of this study is to compare blood loss between using low dose (500 mg) and high~     dose (3 g) topical intra-articular tranexamic acid after total knee arthroplasty in~     double-blind RCT~   "
39932|NCT03044028|"~     The current standard for rehabilitation after TKA consists of guided exercise therapy for up~     to 12 weeks after surgery. This includes inpatient, home, and outpatient therapy. The surgery~     and rehabilitation are highly successful at reducing or eliminating pain experienced~     preoperatively. However, quadriceps femoris muscle (QFM) strength, overall function, and knee~     range of motion are often worse than preoperative levels for as long as 6 months after~     surgery and in some cases may persist for many years after that. Such quadriceps strength~     impairments after TKA have been largely attributed to voluntary activation deficits and can~     lead to a decrease in functional performance such as decreased gait speed, decreased balance~     which can lead to falls, and decreased stair climbing & chair rise abilities.~      Since therapy alone does not adequately restore or improve upon the preoperative functional~     capabilities in a consistent and timely manner, it has been suggested that NMES used~     adjunctively with postoperative rehabilitation will alleviate the quadriceps muscle~     activation deficits. Early NMES use after TKA has been shown to: reduce knee extensor lag,~     increase walking speed, and improve QFM strength, knee range of motion, and function.~     However, NMES initiated one month after TKA did not lead to improved QFM strength or function~     beyond the standard benefits gained from exercise alone, thus suggesting that the timing of~     NMES application after TKA is important.~      It has previously been shown that preoperative QFM strength is predictive of postoperative~     function [6] but the benefit of prehabilitation remains in question. To date, there has only~     been one pilot study assessing the benefits of NMES when initiated preoperatively. This study~     only included 14 patients (9 NMES, 5 control) but was able to show that preoperative NMES~     usage may lead to greater QFM strength gains after TKA. Therefore, it will be important to~     assess the benefits of NMES both preoperatively and postoperatively in order to determine how~     it will be most beneficial to TKA patients.~   "
39933|NCT03044015|"~     BACKGROUND Recent evidence has been published about the effectiveness for the secondary~     prevention of osteoporotic fractures (OF) of the hospital-based fracture liaison services.~      AIM To assess the effectiveness of a primary care based intervention in the secondary~     prevention of OF.~      METHODOLOGY Prospective study of random clusters, defined at the primary-care trust (PCT)~     level. Total study follow-up 3 years. Sample size 1800 patients.~      DESCRIPTION To launch a defined strategy for the identification of OF. To carry out a primary~     care based intervention about lifestyle, diet and drug prescription, if needed, with an~     intensive follow-up in the intervention PCT vs treatment as usual in the control branch.~      ANALYSIS As the outcome are the new OF, a survival analysis will be done. Risk factors will~     be analyzed through Cox proportional hazard regression model stratified by age groups.~      Outcomes :~        -  new OF ratio in intervention vs control areas.~        -  maintenance of the adherence to the pharmacological and non pharmacological~          interventions proposed~        -  assessment of cost-effectivity of the intervention~   "
39935|NCT03043989|"~     This clinical trial is being conducted to recommend a safe and tolerable phase 2 dose of~     docetaxel or cabazitaxel when combined with clarithromycin in men who have developed~     castrate-resistant prostate cancer.~      In the castrate-resistant setting, resistance to taxane therapy inevitably develops. Men who~     develop resistance to taxanes have a very poor prognosis, and few treatment options.~      It is believed that CYP enzymes contribute to docetaxel and cabazitaxel resistance in~     metastatic prostate cancer, and this resistance can be mitigated through pharmacologic CYP~     inhibition. In this study a potent CYP3A inhibitor, clarithromycin, will be co-administered~     concurrently with either docetaxel or cabazitaxel, whose systemic metabolism is dependent of~     CYP3A4, with the intent to overcome resistance to taxanes.~   "
39936|NCT03043976|"~     This study will collect information about physical activity in patients affected by pulmonary~     hypertension, through a specific device that can be worn on the wrist, and which measures~     daily step count. The purpose of the study is to demonstrate whether providing patients with~     their daily step count can increase their levels of daily activity if they have some basic~     targets to achieve. Investigators also wish to compare the effects of this approach in~     increasing daily physical activity, with the benefit gained when a drug therapy for pulmonary~     hypertension is initiated, in patients that have just been diagnosed.~   "
39937|NCT03043963|"~     The main purpose of this study is to learn about the influence of two different behavioral~     interventions (lasting 8 weeks) involving sleep for lowering blood pressure, and to study the~     mechanisms involved. There is research evidence that healthy sleep promotes heart-health and~     may decrease blood pressure, and that sensitivity to insufficient or disrupted sleep may be~     influenced by sex. This research will compare two interventions that are each designed to~     improve sleep health, and will investigate sex differences in response. The project includes~     3 in-hospital stays with biological measurements to evaluate the underlying mechanisms~     associated with the effectiveness of two different blood pressure lowering behavioral~     interventions.~   "
39938|NCT03043950|"~     A safety and efficacy study of first line therapy with Vectibix® in combination with~     irinotecan, 5‑fluorouracil, and folinic acid (FOLFIRI) to validate a prognostic score in~     adult patients with RAS wild-type metastatic colorectal cancer in a real world setting~     (VALIDATE)~   "
39939|NCT03043937|"~     The aim of this work is to demonstrate the variation of cardiac diseases among pregnant~     ladies in our localities, detect maternal & fetal complications and to predict the risk~     factors for poor maternal, fetal & neonatal outcomes~   "
39940|NCT03043924|"~     The aim to evaluate whether activation of the hypothalamic-pituitary-gonadal axis in PCOS is~     associated with transient microstructural and metabolic changes in the female hypothalamus~     using MRI approaches to assess water diffusion and measure proton magnetic resonance spectra.~   "
39941|NCT03043911|"~     The investigator intend to perform an observational study, by adding Respiratory Rate~     monitoring to an already existing Patient SafetyNet system with SpO2 (Oxygen Saturation) and~     PR (Pulse Rate) monitoring. RRa will be blinded to the clinicians and all RRa alarms will be~     deactivated. Retrospective analysis of the observational data collected will be utilized to~     evaluate the potential benefits of additional continuous respiratory rate monitoring.~   "
39942|NCT03043898|"~     This study addresses the question, how does sound propagate from a source in the chest to the~     chest wall? Using sound recorded at the chest as a diagnostic technique has the advantage of~     being non-invasive and non-radioactive, but compared to other techniques it cannot currently~     differentiate well between different diseases. Our aim is to improve our ability to~     differentiate between different diseases using sound recorded at the chest by improving our~     fundamental understanding of mechanisms by which sound propagates through the chest.~      Examples of conditions that could be diagnosed using audible lung sounds are bronchomalacia,~     asthma, lung cancer, interstitial lung disease and chronic obstructive pulmonary disease. The~     methodology of the study will be to place a sound source at a known location in the chest and~     measure the acoustic response on the chest wall with a microphone array.~      The sound source will be created by playing sound down the working channel of a bronchoscope~     and located anatomically using direct imaging. By placing a sound source inside the chest we~     will be able to generate an acoustic map of the chest and test the relative importance of~     different propagation mechanisms. This will be an advance on previous work, which placed a~     sound source at the mouth.~      Subjects will be selected for the study by asking patients undergoing a bronchoscopy~     procedure whether they would be willing to take part in the experiment in addition to their~     standard procedure.~      Procedures will take place in the Bronchoscopy Unit at Addenbrooke's hospital in Cambridge.~     The Unit runs regional speciality clinics in severe chronic obstructive pulmonary disease,~     asthma, lung cancer, bronchomalacia and interstitial lung disease and has a nationally~     significant interventional bronchoscopy service.~      A subsidiary part of the study will collect sound recordings from healthy volunteers and~     patients with common respiratory diseases using the same microphone array. This is to create~     a database of lung sounds and quantify inter-subject variability.~      The study will last approximately 30 months.~   "
39943|NCT03043885|"~     Improved predictability and quality of bone healing after a tooth is removed is clinically~     relevant, in that, it improves our ability to achieve successful implant placement at~     edentulous sites. Currently, a variety of grafting materials and biologic agents are utilized~     clinically to improve bone healing and provide sufficient dimensions of bone to support a~     dental implant. Platelet rich fibrin (PRF) is one such product that can be used for this~     application. PRF is a concentrated blood product attained from the patient's own blood~     consisting of a natural bioscaffold with integrated growth factors capable of sustained~     release. Once processed, PRF is implanted back into the patient at the wound or defect site~     to encourage healing. The literature regarding PRF is currently dominated by heterogeneous~     applications of PRF for reparative and regenerative therapies without a consensus of its~     clinical efficacy and appropriate application. In this clinical study, PRF will be evaluated~     to ascertain its clinical efficacy in improving bone formation and alveolar dimensional~     stability after tooth extraction. A classic bone grafting material used for this purpose,~     freeze dried bone allograft (FDBA), will be incorporated with the PRF or compared directly to~     PRF alone. It is hypothesized that the natural scaffold and incorporated growth factors of~     PRF augmented with the solubility resistance of FDBA will function as an ideal bioscaffold to~     promote bone healing to a greater extent compared to PRF, FDBA, or blood clot alone.~   "
39944|NCT03043872|"~     This is a phase III, randomized, open-label, multicenter, global study to determine the~     efficacy and safety of combining durvalumab ± tremelimumab with platinum based chemotherapy~     (EP) followed by durvalumab ± tremelimumab maintenance therapy versus EP alone as first-line~     treatment in patients with extensive-stage small-cell lung cancer.~   "
39992|NCT03043248|"~     This study comprises 2 cohorts, and in each cohort, the study will be conducted as an~     open-label add-on study.~      The purpose of the study is to investigate the pharmacokinetics of each substrate in~     concomitant administration of a single dose of the P-glycoprotein substrate digoxin (Cohort~     A) or the CYP3A4 substrate midazolam (Cohort B) during repeated administration of TRK-700 in~     healthy adult males.~   "
39945|NCT03043859|"~     In Canada, there is a growing burden of type 2 diabetes (T2D). Approaches to implement~     nutrition recommendations and promote sustainable eating behaviours are required. The~     investigating research team developed an educational curriculum that includes practical~     information about Eating Well with Canada's Food Guide, portion control and food label~     reading. The research team also developed a cookbook, Pure Prairie Eating Plan which~     translates the Canadian Diabetes Association Clinical Practice Guidelines into a practical~     menu plan with recipes, grocery lists and cooking tips. These resources promote behaviour~     change and skill development to independently manage diabetes. These resources have been~     successfully employed in a clinical study trial conducted at the University of Alberta and in~     a pilot project at the community (Pure Prairie Living Program -PPLP), and showed beneficial~     effects in management of diabetes among participants. The objective of this study is to~     implement and evaluate the PPLP in a community level, to promote healthy lifestyle among~     people with T2D in the general community. To meet the study objective, 60 adult participants~     with diagnosed T2D will be recruited from three different primary care networks (total of 180~     participants) and at each site 30 participants will be randomized into the education~     intervention (PPLP) and 30 will be the wait-listed controls (CON) receiving usual care. PPLP~     participants will attend 5, biweekly education sessions and a grocery store tour scheduled~     over a period of 3 months.The benefits of the lifestyle intervention on physiological~     indicators (BMI, Haemoglobin A1C, blood lipids, blood pressure) and lifestyle choices~     (adherence to dietary recommendations, self-efficacy and participation in physical activity)~     will be examined.~   "
39946|NCT03043846|"~     This is a not interventional, pragmatic, prospective, randomized (cluster) study to evaluate~     the potential benefit of a Treat to Target approach in comparison to routine treatment (i.e.~     usual care) in patients with axial spondyloarthritis.~   "
39947|NCT03043833|"~     This study represents Phase II of a research program involving an international collaboration~     with Macquarie University (Sydney, Australia) to implement an Internet-based cognitive~     behavior therapy for the treatment of anxiety and depression in French-speaking Canadians~     from the Atlantic Provinces.~      The primary objective is to establish the clinical efficacy of a French-Canadian self-guided~     format version of the Wellbeing Course by conducting a randomized-control trial where an~     experimental group will be compared to a waitlist control group. A secondary objective is to~     demonstrate the course's acceptability through participants' satisfaction with the course.~   "
39948|NCT03043820|"~     There is increasing clinical and molecular evidence for the role of hormones and specifically~     estrogen and its receptor in schizophrenia. A selective estrogen receptor modulator,~     raloxifene, stimulates estrogen-like activity in brain and can improve cognition in older~     adults. The present study will test the extent to which adjunctive raloxifene treatment~     improved cognition and reduced symptoms in young to middle-age men and women with~     schizophrenia.~      154 patients with a schizophrenia spectrum disorder will be recruited in a multicenter~     twelve-week, randomized, double-blind, placebo-controlled, parallel trial of adjunctive 120mg~     raloxifene treatment in addition to their usual antipsychotic medications.~      The investigators hypothesize that daily treatment with raloxifene 120 milligrams (mg) in~     addition to antipsychotic treatment improves cognition, reduces psychotic symptoms, increases~     social and personal functioning and reduces health care costs, as compared to placebo.~   "
39949|NCT03043807|"~     To assess the safety of treating men with oligometastatic prostate cancer with the following~     therapy: (1st) Systemic chemo-hormonal therapy with up to 6-months (~24 weeks) of adjuvant~     androgen deprivation and up to 6 cycles of chemotherapy, (2nd) definitive local tumor control~     with adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to~     oligometastatic lesions. The men will receive a total of 2 years of androgen deprivation.~     Androgen blockade will be the same throughout the course of treatment.~   "
39950|NCT03043794|"~     This is a Phase II trial of preoperative stereotactic radiation to the breast for low risk~     breast cancer.~   "
39951|NCT03043781|"~     This study evaluates the use of intermittent epidural boluses compared to continuous infusion~     in maintaining epidural pain relief in labor.~      The medicine solution used contains, in addition to bupivacain and fentanyl, adrenalin in~     both groups.~   "
39952|NCT03043768|"~     In Parkinson's disease (PD), alpha-synuclein accumulation in cutaneous autonomic pilomotor~     and sudomotor nerve fibers has been linked to autonomic nervous system disturbances even in~     the early stages of the disease. The investigators recently introduced a non-invasive~     technique to assess autonomic adrenergic fiber function using the quantitative pilomotor~     axon-reflex test (QPART). In the present study the investigators aim to assess the~     association between alpha-synuclein mediated structural autonomic nerve fiber damage and~     nerve function in PD, elucidate the role of neuropathy progression during the early disease~     stages, and test reproducibility and external validity of pilomotor function assessment using~     quantitative pilomotor axon-reflex test (QPART) and sudomotor function via quantitative~     direct and indirect test of sudomotor function (QDIRT).~      A prospective controlled study will be conducted in four sites (Dresden, Germany; Berlin,~     Germany; Budapest, Hungary; Boston, USA). A total of 52 male and female patients with~     idiopathic PD (Hoehn&Yahr 1-2) and 52 age- and sex-matched healthy controls will be~     recruited. Pilomotor function will be evaluated after iontophoresis of phenylephrine on the~     dorsal forearm to elicit a cutaneous axon-reflex mediated response (goosebumps). Silicone~     impressions of the stimulated area will be obtained, scanned and quantified for pilomotor~     muscle impressions by number, impression size and area of axon-reflex pilomotor erection~     spread. Sudomotor function will be evaluated after axon-reflex stimulation via iontophoresis~     of acetylcholine on the dorsal forearm. Stained sweat droplets will be captured using~     repeated digital photography and will be quantified over time for droplet number and~     axon-reflex spread. Sympathetic skin responses following deep inspiration will be analyzed~     using skin conductance quantification. Testing and evaluation of autonomic and motor symptoms~     will be performed at baseline, after 2 weeks, 1 year, 2 years and 3 years. Skin biopsies will~     be obtained at baseline and after 3 years and will be analyzed for nerve fiber density and~     alpha-synuclein accumulation.~      The investigators expect that this study will unveil whether progression of autonomic nerve~     dysfunction assessed via pilomotor and sudomotor axon-reflex tests is related to progression~     of autonomic symptom severity and alpha-synuclein deposition in PD. Additionally, potential~     applications of the used techniques include interventional studies evaluating~     disease-modifying approaches and clinical assessment of autonomic dysfunction in patients~     with PD.~   "
39953|NCT03043755|"~     Propose to evaluate efficacy of association between US guide parasternal block and pectorals~     nerves block (PECS) as anesthetic option for breast surgery (medial quadrantectomy and simple~     mastectomy).~      All patients undergoing medial quadrantectomy and simple mastectomy in 6 months period will~     be observed.~      All patients receive: US guide parasternal block at T4 and T6 space with 6ml of ropivacaine~     0,75% and PECS type 2 block performed with 24ml of ropivacaine 0,75%.~      During surgery patients receive light sedation with continuous infusion of propofol~      Will be observed:~      Additional local anesthetic infiltration from surgeon. Pain at rest and during movement~     quantified as Numerical Rating Scores (0-10) during the first 12 hours postoperatively.~      Eventual side effects such as nausea/vomiting.~   "
39957|NCT03043703|"~     Detecting mild forms of obstructive sleep apnea (OSA) easily and efficiently might help to~     identify and improve care for patients suffering from wake reactions at night. The AirSense~     10 for Her is able to detect respiratory effort related arousals (RERAs) through changes in~     the flow of air. The algorithm of the AirSense 10 will be compared with scoring via~     polysomnography (PSG). 129 patients shall be observed in a sleep facility under suboptimal~     Treatment (i.e. low pressure) with positive airway pressure (PAP) therapy.~   "
39958|NCT03043690|"~     This study is a pooled statistical analysis of the data from 2 studies concerning efficacy of~     ammonium-succinate based dietary supplement. In both studies group 1 took the~     ammonium-succinate based dietary supplement and the group 2 took placebo.~   "
39959|NCT03043677|"~     To characterize circulating DC subsets from healthy controls and IBD patients and to assess,~     following an ex vivo challenge, the effect of anti-TNF (infliximab, adalimumab and~     golimumab), anti-p40 -IL-12/IL-23- (ustekinumab) and anti-α4β7 (vedolizumab) immunomodulators~     on both the GI production of soluble immune mediators and the mucosal capacity to alter the~     recruitment capacity of circulating DC subsets. It is expected that such approach will~     provide further information on the action mechanisms of such therapies on IBD patients,~     allowing a better understanding of the pathophysiology of this disease and the identification~     of tissue-specific therapeutic targets, thus avoiding collateral problems associated with~     systemic immunomodulation.~   "
39960|NCT03043664|"~     This study is for patients with non-resectable, recurrent, or metastatic well or moderately~     differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NETs).~      The study will be conducted in two stages: 1) Safety Run-In and 2) Expanded Cohort.~        1. Safety run-in: The first stage will include a safety run-in of 6 patients treated with~          pembrolizumab 200 mg intravenous (IV) every 3 weeks and lanreotide depot 90mg~          subcutaneous (SQ) every 3 weeks. Up to 6 patients at the Duke Cancer Institute will be~          accrued at the starting dose level. If one or less subject meets treatment-related~          discontinuation criteria (as specified in the protocol) during Cycle 1, then the study~          will proceed to the second stage, Expanded Cohort.~        2. Expanded Cohort: Patients will be treated with pembrolizumab 200mg IV every 3 weeks and~          lanreotide depot 90mg SQ every 3 weeks as determined by the Safety Run-In Cohort.~   "
39961|NCT03043651|"~     This is an open-label study to evaluate the safety of continued therapy with oral~     treprostinil in subjects who have completed Study TDE-HF-301. This study will provide~     long-term, open-label data regarding the effect of continued long-term oral treprostinil~     therapy for the treatment of pulmonary hypertension (PH) associated with heart failure with~     preserved ejection fraction (HFpEF). Subject visits will occur at Baseline, Weeks 6, 12, 18,~     24, and every 12 weeks thereafter until either oral treprostinil becomes commercially~     available to treat PH associated with HFpEF or the study is discontinued by the Sponsor.~   "
39962|NCT03043638|"~     The aim of this study was to evaluate the effectiveness of platelet rich plasma (PRP)~     combined with coronally advanced flap plus acellular dermal matrix application (CAF+ADM) in~     the treatment of multiple adjacent gingival recessions (MAGRs).~      12 patients with 84 Miller Class I or II recession defects were participated. Sites were~     randomly assigned into CAF+ADM+PRP or CAF+ADM groups. Gingival recession depth (GRD),~     recession width (GRW), width of keratinized tissue (WKT), creeping attachment (CRA), root~     coverage (RC) as well as plaque index, gingival index, probing depth (PD), and clinical~     attachment level (CAL) were recorded at baseline and 3rd,6th and 12th months postoperatively.~     The data were analyzed statistically.~   "
39963|NCT03043625|"~     Background: Non-specific neck pain (NS-NP) is characterized by pain in structures located in~     the region between the superior nuchal line and the spinal process of the first thoracic~     vertebra, without association with any specific systemic disease provided by multifactorial~     and/or little known causes.~      Objective: The objective of the present study will be to verify the clinical effects of MV~     through visceral nociceptive inhibition in NS-NP patients with functional dyspepsia.~      Methods: In this study sixty NS-NP patients with functional dyspepsia (age: 18 and 50 years)~     will be randomized in into two groups: visceral manipulation group (VMG) (n =30) and control~     group (CG) (n =30). The VMG will be treated with visceral manipulation to the stomach and~     liver wile CG received placebo treatment. The immediate effects and 7 days after treatment~     will be evaluated through pain, cervical range, and electromyographic activity of the upper~     trapezius.~   "
39964|NCT03043612|"~     The purpose of this study is to evaluate the feasibility of the Cook Ureteral Stent to reduce~     post-stent placement pain and urinary symptoms in patients following ureteroscopy for~     urolithiasis.~   "
39965|NCT03043599|"~     The purpose of the safety run in Phase I portion of this study is to confirm the recommended~     Phase II dose of ipilimumab and nivolumab among participants treated with combined thoracic~     radiation therapy (30 Gy in 10 fractions) and nivolumab/ipilimumab following standard~     treatment with 4-6 cycles of platinum-based chemotherapy.~      The purpose of the Phase II portion of this study is to estimate the 6-month Progression Free~     Survival (PFS) rate among participants treated with ipilimumab and nivolumab with thoracic~     radiation therapy (30 Gy in 10 fractions) after standard treatment with 4 to 6 cycles of~     platinum based chemotherapy.~   "
39966|NCT03043586|"~     This is a human, prospective and retrospective, single-center study of patients who have~     undergone treatment for acromegaly in New York City since 1981. The project will~     characterize, among other factors, the treatment methods received by patients, who~     administered the treatments and the success of this therapy in terms of biochemical control.~   "
39967|NCT03043573|"~     The present collaborative R01 study, between Cornell and Johns Hopkins, aims to compare~     Problem Adaptation Therapy for Mild Cognitively Impaired Older Adults (PATH-MCI) vs.~     Supportive Therapy for Cognitively Impaired Older Adults (ST-CI) in improving cognitive,~     affective, and functioning outcomes.~   "
39968|NCT03043560|"~     This project is designed to examine the neuronal KCNQ2/3 potassium (K+) channel subtype as a~     novel treatment target for mood disorders through the administration of the KCNQ-selective~     channel opener ezogabine (Potiga, GlaxoSmithKline; FDA-approved for the treatment of seizure~     disorders).~   "
39969|NCT03043547|"~     is an open label, randomized, multicenter phase II trial~   "
41850|NCT03018925|"~     This study aims to characterize the changes on intestinal microbiota pattern associated with~     the use of golimumab in order to determine if intestinal microbiota markers may correlate~     with golimumab therapeutic effect in patients naïve & non-naïve to anti-TNF treatment~   "
39970|NCT03043534|"~     This will be a randomized investigator blinded study of 40 men age 20-60 (inclusive) with~     symptoms of mild-moderate PFB based on Investigator Global Assessment (IGA). Subjects will be~     divided into two groups: the Control group of 20 subjects and the Experimental group of 20~     Subjects. Subjects will be seen at Screening/Baseline, and 6 weeks.~      All subjects will use their normal razors and shave products during the six week study. The~     Experimental group of subjects will also be given the study product Pre-Shave Gel and~     Cleansing Brush.~   "
39971|NCT03043521|"~     The purpose of this study is to compare and evaluate impact on pharmacodynamic~     characteristics of CJ-12420 and dexlansoprazole with evening dosing in healthy male~     volunteers~   "
39972|NCT03043508|"~     OBJECTIVES:~      The primary objective of this study is to evaluate the effect of estrogen on the development~     of the PNET in MEN1 patients.~      The secondary objective is to evaluate the overall survival and disease specific survival in~     patients who have confirmed MEN1 with or without PNET and a pancreatic neuroendocrine tumor~     in relation to their hormone status. The secondary objective is to evaluate clinicopathologic~     features in relation to hormone status.~   "
39973|NCT03043495|"~     A dose-ranging study to test various doses of Dexamethasone (2, 4 & 8 mg) to be used as an~     adjuvant to Local anesthetic drugs in ultrasound guided low volume Supraclavicular brachial~     plexus block to find the best balance between valuable effects (mainly duration of analgesic~     Effect) and side-effects (mainly increased random blood sugar levels)~   "
39974|NCT03043482|"~     The purpose of the study is to evaluate the safety, tolerability, and PK following single and~     multiple ascending dose administration of VS-105 in healthy subjects and patients with~     chronic kidney disease stage 5D (CKD-5D) on hemodialysis.~   "
39975|NCT03043469|"~     Dysfunctional breathing (DB) is a respiratory condition characterised by an abnormal~     breathing pattern, among other complaints, that can occur either in the absence of other~     pathophysiology (primary DB), e.g. anxiety-related factors, or secondary to cardiopulmonary~     disease (secondary DB), e.g. asthma. As a consequence, patients may experience breathlessness~     and present with periods of increased ventilation or erratic breathing, interspersed with~     episodes of breath holding or deep sighs. In addition to respiratory symptoms, DB also~     generates non- respiratory symptoms (e.g. dizziness and increased heart rate). It is~     estimated 1 in 10 people in the United Kingdom (UK) have DB. However, DB remains poorly~     understood, with no standardised approach to diagnosis and assessment.~      The purposes of this study are:~      Study 1) To identify physiological, functional and psychological characteristics of~     participants with DB compared to healthy participants.~      Firstly, symptoms, lung function, respiratory gas analysis, exercise capacity, respiratory~     muscle function, respiratory motion, level of physical activity, quality of life and anxiety~     & depression scores will be assessed in 20 participants with primary DB, 20 with secondary DB~     and compared to 20 healthy participants.~      Study 2) To develop an assessment tool based on physiological, functional or psychological~     variables found to be different between any of the 3 groups in Study 1.~      In order to do that, 54 people with DB (between primary and secondary) and 27 people~     presenting with breathlessness secondary to restrictive lung disease will be assessed.~     Analysis of these data will determine whether these variables can be used as a diagnostic~     tool capable of distinguishing DB from restrictive lung diseases characterised by~     breathlessness.~      The recruitment period will be 1-2 years, with an individual participation of 9 days; 1-day~     on site testing, plus 7-day home activity monitoring, and 1 day to return the activity~     monitor (which will happen whenever the participant needs to return to the site).~   "
39976|NCT03043456|"~     In this research, the investigators are comparing the new thermoplastic material side by side~     with the conventional poly methyl methacrylate for fully edentulous patients measuring their~     satisfaction and microbiological count.~   "
39977|NCT03043443|"~     A double blind Randomized Controlled Trial with two arms will be used. Subjects with Alcohol~     use disorder and sleep problems will be recruited and assigned randomly to the active~     treatment Melatonin or Placebo arms. All subjects will be assessed at baseline for~     demographics. Sleeping problems will be the primary outcome of the study, and it will be~     measured by the Pittsburgh sleep quality index (PSQI) scale.~   "
39978|NCT03043430|"~     Investigators plan to conduct a randomized, double-blinded, controlled study among pediatric~     patients requiring minor procedures in the Emergency Department setting. Patients will be~     randomized to one of two arms of intranasal treatments: ketamine 1.0 mg/kg (K) or midazolam~     0.3 mg/kg (M). The primary outcome will be change in anxiety using the Modified Yale~     Preoperative Anxiety Scale (mYPAS).~   "
39979|NCT03043417|"~     This project is measuring the effectiveness of an anti-stigma intervention among primary care~     providers. Both staff and clients will be asked to complete survey data in order to measure~     the effectiveness. This is a randomized control trial in that three health centres will~     receive the intervention and three will not. Results will determine if this intervention~     reduces stigma among staff toward people with a mental health problem and/or substance use~     problem.~   "
39980|NCT03043404|"~     To confirm the acute performance and safety of the Lotus™ Valve Flex System for transcatheter~     aortic valve replacement (TAVR) in symptomatic patients with severe calcific aortic stenosis~     who are considered high risk for surgical valve replacement.~   "
39981|NCT03043391|"~     The purpose of the study is to confirm the safety of the selected dose and potential toxicity~     of oncolytic poliovirus (PV) immunotherapy with PVSRIPO for pediatric patients with recurrent~     WHO grade III or IV malignant glioma, but evidence for efficacy will also be sought. The~     primary objective is to confirm the safety of the selected dose of PVSRIPO when delivered~     intracerebrally by convection-enhanced delivery (CED) in children with recurrent WHO Grade~     III malignant glioma (anaplastic astrocytoma, anaplastic oligoastrocytoma, anaplastic~     oligodendroglioma, anaplastic pleomorphic xanthoastrocytoma) or WHO Grade IV malignant glioma~     (glioblastoma, gliosarcoma). A secondary objective is to estimate overall survival (OS) in~     this population.~   "
39982|NCT03043378|"~     The goal of this research study is to learn how frequently cancer patients in the Supportive~     Care Center have chronic, non-malignant pain. Chronic, non-malignant pain is pain that is~     neither related to cancer nor its treatment and lasts beyond the normal tissue healing time~     of 3 months.~   "
40039|NCT03042637|"~     The management of steroid-resistant nephrotic syndrome (SRNS) remains a persistent problem~     for investigators in part because of the wide array of pathogenic mechanisms that contribute~     to these disorders as well as the lack of adequately powered, controlled trials. While~     glucocorticoids remain the primary therapy for many forms of protein uric glomerular~     diseases, prolonged use is associated with significant morbidities including steroid induced~     diabetes, metabolic bone disease, and excessive weight gain.~   "
41083|NCT03028987|"~     The purpose of this study is provide a better understanding of the adaptive immune response~     to the licensed flu vaccines. The investigators hope the information learned from this study~     will help identify and describe important factors of influenza immunity especially of or~     specific proteins associated with the T-cell immune response.~   "
39983|NCT03043365|"~     Background:~      Fish oils are known to be beneficial to health and believed to be cardio-protective. Omega-3~     fatty acid is the most known fish oil available in the market. LCMUFA (long-chain~     monounsaturated fatty acids) is also a fish oil but it is derived from fish that consumes a~     diet rich in omega-11 fatty acid. Researchers want to study omega-11 fatty acid enriched fish~     oil and understand it s effect on cardiovascular health.~      Objective:~      To understand the effects of LCMUFA from fish oil on cardiovascular health.~      Eligibility:~      Healthy volunteers ages 18 and older with no history of cardiovascular disease~      Design:~      Participants will be screened with:~        -  Medical history~        -  Physical exam~        -  Fasting blood and urine tests~        -  Optional stool sample~        -  Questions about their diet, exercise, and the types of medicines and dietary supplements~          they take~        -  7-day food diary~        -  Cardio-Ankle Vascular Index (CAVI): Blood pressure is taken in the arms and legs. The~          heart is monitored.~        -  After the screening visit, participants will take 4 gel capsules, 3 times a day after~          meals, for 8-10 weeks.~        -  Electrocardiogram (EKG)~      Participants will have 3 additional visits. All include repeats of the screening tests.~      Visit 2 is 8 weeks after the screening visit. Participants will stop taking the capsules for~     8 weeks after this visit.~      Visit 3 is at least 16 weeks after starting the supplement. Participants will take 4~     capsules, 3 times a day after meals, for 8 weeks after this visit.~      Visit 4 is 8 weeks after starting the second supplement.~   "
39984|NCT03043352|"~     HYPOTHESIS:~      Investigators hypothesize that by provision of care at household level in a community through~     lady health workers will as effective (recovery rate, burden of SAM, cost effective,~     coverage) as through health care providers at facility level. OBJECTIVES~        1. To evaluate the effectiveness (rate of recovery, burden & coverage), of SAM standard~          management of children 06-59 months delivered at household level by first level health~          care providers (Lady health workers) compared with the standard CMAM program delivered~          at health facility by Govt./ACF staff.~        2. To evaluate the cost effectiveness of treatment of SAM provided by LHWs at community~          level versus treatment delivered at health facility by Govt/ACF staff.~      STUDY DESIGN:~      Cluster randomized controlled trial~      SAMPLE SIZE & RANDOMIZATION:~      Investigators took 6% prevalence to calculate the sample size with an expected reduction of~     20%. A sample size of 3 clusters per group with 150 individuals per cluster is needed. STUDY~     METHODOLOGY Intervention (Group A): LHWs will identify and treat all cases of severe acute~     malnutrition (SAM) as per the study eligibility criteria (MUAC < 11.5 cm) and manage all~     cases of SAM without complications at home following the national CMAM guidelines. Control~     (Group B): LHWs will identify SAM as per the CMAM guidelines (MUAC < 11.5 cm) and will refer~     all cases to the health facility (ACF) for further management and counselling by health~     workers at facility.~   "
39985|NCT03043339|"~     This is a hypothesis-generating pilot study. The intent is to model the impact of~     perioperative practices on the intestinal microbiome and possibly associate these conditions~     with the final microbiome status (e.g., number of resistance genes and diversity associated~     with perioperative practices and preoperative microbiome status). Participants will include~     individuals who are having surgery to either receive or donate a kidney. To determine the~     diversity change of the intestinal microbiota over time, rectal swabs will be collected~     before surgery and at several time points after surgery, with the last swab collected 30 days~     after surgery.~      This pilot study is to obtain preliminary data to support the rationale and design for a~     subsequent clinical trial. This study is designed to understand the intestinal microbiota~     diversity in the setting of renal transplant surgery and the clinical significance of~     antibiotic use and the associated resistome (collection of all antibiotic resistance genes~     and precursors within a sample).~   "
39986|NCT03043326|"~     The purpose of the study is to evaluating the acceptability, use and adherence of a~     pre-exposure prophylaxis (PrEP) program using the co-formulation tenofovir disoproxil~     fumarate 300 mg/emtricitabine 200 mg (TDF/FTC) administered daily by mouth, at four health~     facilities and one community-based organization providing health care services for MSM and~     transgender women.~      This is an Observational, longitudinal, multicenter, open-label study to evaluate the~     acceptability, use and adherence to TDF/FTC-based PrEP in volunteer men who have sex with men~     and transgender women at substantial high risk of acquiring HIV, who were prescribed for PrEP~     , following the clinical guidelines to prevent HIV infection of the U.S. Centers for Disease~     Control and Prevention (2014) and the World Health Organization (2015).~      Follow-up: Participants will be followed for 96 weeks (approximately two years) after the~     start of prophylactic treatment.~      Implementation Target Population: Adults (≥18 years of age), without HIV infection diagnosis,~     and who were prescribed with PrEP and have a substantial risk of acquiring HIV infection~     according to the international guidelines for HIV prevention.~      Sample Size: 1,000 participants~      Implementation Sites:~        1. Asociación Civil Impacta Salud y Educación, Barranco study site~        2. Asociación Civil Impacta Salud y Educación, San Miguel study site~        3. Asociación Civil Selva Amazónica, ACSA study site~        4. Asociación Vía Libre, Vía Libre study site~        5. Espacio Común, Epicentro study site~      Primary Objectives:~        1. Describing the acceptability and its socio-demographic and sexual behavior correlates~          for the use of PrEP.~        2. Evaluate the persistence of the use of PrEP and its correlates with risk behaviors~        3. Evaluating the adherence to the PrEP using self-reporting and pill counts~      Secondary Objectives:~        1. Describing the changes over time in risky sexual behavior among study participants.~        2. Describing the number of participants who acquire HIV infection.~        3. Evaluate the deviation of the indication of use of PrEP through self- reporting of its~          sale or sharing with third parties.~   "
39987|NCT03043313|"~     This phase II trial studies how well the HER2 inhibitor tucatinib (ONT-380, ARRY-380) works~     in combination with trastuzumab in treating patients with HER2-positive (HER2+) metastatic~     colorectal cancer (CRC). Tucatinib may stop the growth of tumor cells by blocking HER2, a~     receptor needed for cell growth in patients with HER2+ tumors. Monoclonal antibodies, such as~     trastuzumab, may interfere with the ability of HER2+ tumor cells to grow and spread. Giving~     tucatinib and trastuzumab in combination may work better in treating patients with HER2+~     metastatic CRC.~   "
39988|NCT03043300|"~     This prospective, observational pilot study is designed to assess feasibility, refine the~     target population, and quickly test qualitative and quantitative changes in the microbiome~     after short-term travel to South or Southeast Asia, regions where rates of travelers'~     diarrhea and intestinal colonization with antimicrobial resistant bacteria are highest.~      To measure the diversity change of the intestinal microbiota, participants will complete a~     questionnaire and provide a stool specimen at three different time points: prior to~     traveling, two weeks after returning from traveling, and 14 weeks after returning from~     traveling.~   "
39989|NCT03043287|"~     This study is a retrospective chart review of patients treated with onabotulinumtoxinA~     (BOTOX®) for idiopathic overactive bladder (OAB) and will determine voiding efficiency (VE)~     cutoff ratios that predict post-procedure urinary retention requiring catheterization.~   "
39993|NCT03043235|"~     This research study will examine how ethnic/racial background, body composition (%body fat),~     and the location of body fat affect the ability of the hormone insulin to promote uptake of~     blood sugar in persons who are 19 to 45 years of age. When insulin is ineffective in~     promoting blood sugar uptake, this condition is termed insulin resistance. Insulin~     resistance plays a major role in the development of chronic metabolic diseases (such as type~     2 diabetes, cardiovascular disease, and cancer), many of which differ with race. Previous~     studies suggest that insulin resistance is higher in African-Americans (AA) vs.~     European-Americans (EA). However, results from these studies remain unclear due to different~     testing measures used for insulin resistance as well as differences in body fat between~     individuals. Results from this research study may help explain why insulin resistance differs~     with genetic background and may guide development of personalized treatment strategies with~     implications for several chronic metabolic diseases (e.g., type 2 diabetes, cardiovascular~     disease, and cancer).~   "
39994|NCT03043222|"~     For ageing men, Health related quality of life ( HRQoL) is challenged by two common issues:~     the onset of bothersome urinary symptoms attributable to prostate enlargement and diminishing~     ability to maintain normal sexual activity and function; both issues are important to men,~     yet often the treatment of the former has adverse effects on the latter. Current medical and~     surgical treatments offer symptomatic improvement of urinary symptoms. However long recovery~     times, degradation of sexual function and incontinence may negatively affect a patient's QoL.~      Prostatic urethral lift (PUL) and prostate artery embolization (PAE) represent two evolving~     techniques with contrasting mechanisms of action (mechanical decompression vs angiographic~     embolization). Both are minimally invasive, yield relief of urinary symptoms and have similar~     safety profiles. More importantly neither causes degradation of sexual function or urinary~     continence. Although multiple studies are being reported on PUL and PAE alike, currently~     there are no prospective clinical trials comparing these two technologies. We aim to~     prospectively evaluate and compare HRQol outcomes of PUL and PAE. Results of this study could~     have a great impact on patient outcomes in men opting for minimally invasive, sexual function~     sparing treatment options for symptom relief from prostate enlargement.~   "
39995|NCT03043209|"~     Investigators aim to use comparative exome and/or genome sequencing to discover causative~     molecular lesions for phenotypes hypothesized to be caused by somatic mutations. For this~     study, investigators have targeted hypertrophic cardiomyopathy.~   "
39996|NCT03043196|"~     The purpose of the present study was to evaluate the effects of subgingival delivery of~     Rosuvastatin gel as an adjunct to scaling and root planing in Smokers With Chronic~     Periodontitis (CP) patients.~   "
39997|NCT03043183|"~     This study is a prospective, single-center, randomized controlled trial. The study protocol~     was approved by the Ethics Committee at the First Hospital of Jilin University.The~     perioperation nutritional status will be assessed in gastric cancer patients within ERAS~     protocols.The ERAS patients were randomly divided into perioperational nutrition support~     group and conventional pathway group . Inter-group differences were evaluated for nutritional~     index,clinical recovery index, complications etc.~   "
39998|NCT03043170|"~     Background to the research Patients present to Emergency Departments (ED) with a spectrum of~     illness, many of which are life- threatening. The body has the ability to compensate in the~     early stages when things go wrong so that on the surface patients do not appear as sick as~     they really are. Under-diagnosis of severity of illness leads to under-treatment, unnecessary~     mortality, and unnecessary hospital costs. Earlier diagnosis and consequent treatment will~     result in prudent healthcare, cost-benefit and better patient outcomes.~      Evaluating the true underlying patient haemodynamics such as cardiac output, cardiac power~     and peripheral pressures gives vital clues to the hidden seriousness of illness and is a~     guide to better management. Few EDs in the world assess such haemodynamics. After evaluating~     a haemodynamic protocol one centre in Australia was able to reduce its death rate for septic~     shock at 30 days from 38% to 7%. We would like to evaluate whether the same would occur if~     applied across EDs in Wales. However, before we can do that we need to strengthen our~     understanding of haemodynamics, and of relevant protocols and non-invasive devices that help~     us to acquire such information.~      Study Design After ethics and institutional approval is obtained from we will conduct a~     prospective, single-centre, cohort study on 354 adult patients with possible shock associated~     with an acute illness or injury who present to the Emergency Department of the University~     Hospital of Wales, and follow them up for 7 days. 354 is a credible number to confirm that~     the strategy works.~      Written consent will be obtained either from the patient or a relative wherever possible but~     a waiver of consent apply to patients who, because of confusion, unconsciousness or severe~     disability, may be unable to give consent. In these cases, consent will first be sought from~     a second doctor and/or nurse. Thereafter, consent will be obtained from the patient or a~     relative as soon as practically possible.~      What you hope to discover~      We expect to discover that:~        -  Uscom variables predict 7-day survival and ICU admission~        -  Uscom variables improve the detection and classification of shock~        -  The LiPS definition can be improved.~        -  The objective definition is better than doctors experience~        -  Patients have a good experience and are satisfied with care~   "
39999|NCT03043157|"~     This is an adaptative study where each participant's rocuronium dose will depend on the~     previous patient's response, being higher if it was not enough and lower if it was more than~     enough.~   "
40000|NCT03043144|"~     Malnutrition is an important complication of advanced kidney disease and impairment in smell~     and taste may affect nutritional status. This study will examine the association between~     impairment in smell and taste and nutritional and functional markers among patients with end~     stage renal disease, as well as risk factors for smell and taste impairment.~   "
40001|NCT03043131|"~     Metabolic acidosis is a frequent problem in cardiopulmonary bypass. The cause is poorly~     understood, but it appears to be multifactorial. It is assumed to be result of hypoperfusion~     with resultant lactatemia. And other theories include bicarbonate dilution to excessive~     proton activity and diluting fluid.The main three contributors for the development of~     metabolic acidosis are stress of anaesthesia, surgery and Cardio Pulmonary Bypass(CPB)~     prime.Even after research discussion and debate, there is no agreement upon ideal prime.The~     literature is extensive, comparing different types of colloids, colloids versus crystalloids,~     synthetic versus organic, and inclusion of numerous additions in an attempt to make a grossly~     unphysiological state the least disruptive to the body as possible~   "
40065|NCT03042299|"~     The purpose of this study is to evaluate the bio-equivalence of a single oral administration~     of TAK-536 pediatric formulation (granules) in comparison with a TAK-536 commercial~     formulation in Japanese healthy adult male participants in an open label, 2-period,~     2-treatment, cross-over design.~   "
41084|NCT03028974|"~     The purpose of the study is to get a better understanding of the natural and adaptive immune~     response to the flu virus and to compare the immune cell responses to FDA-licensed flu~     vaccines in nasal mucosal cells and in blood.~   "
40002|NCT03043118|"~     Studies have shown that when exposed to a variety of food and flavor options people tend to~     consume more than when only one item is presented. This strategy has been used to increase~     vegetable intake in adults and during snacktime in children. Increasing vegetable consumption~     in children is important because higher vegetable intake has been associated with reduced~     risk of disease and because vegetables can help prevent weight gain by lowering the energy~     density of a meal. The purpose of this study was to investigate the effects of using herb and~     spice blends to create flavor variety in carrots as a model vegetable in a laboratory test~     meal. We predict that children will consume more vegetables and that the energy density of~     the meal will be lower when a variety of seasoned carrots are presented in comparison to a~     single flavor. A secondary goal of the study was to determine other influences that may~     predict children's liking and intake of seasoned vegetables, such as previous exposure,~     infant feeding practices, and genetic bitter sensitivity.~   "
40003|NCT03043105|"~     To explore the effectiveness and safety of thalidomide, cyclophosphamide and prednisone (TCP~     regimen) in newly diagnosed Multicentric Castleman's disease (MCD) patients.~   "
40004|NCT03043092|"~     Transcranial Doppler ultrasound is bedside tool use to assess cerebral blood perfusion in~     critically ill patients. We sought to conduct a prospective, single centre study aiming to~     determine whether chronic vascular diseases may be a confounder in transcranial Doppler~     ultrasound assessment in critically ill patients.~   "
40005|NCT03043079|"~     Quantitative radiographic imaging holds promise as a novel and innovative strategy to assess~     ventral hernia patients. Assessing abdominal wall changes surrounding ventral hernia using~     shear wave velocity values measured with ultrasound will identify features of the abdominal~     wall that differ between healthy volunteers and subjects scheduled to have ventral hernia~     repair. Through the use of ultrasound including shear wave velocity measurements, the~     abdominal wall of 25 subjects scheduled to have ventral hernia repair will be compared to~     those of 35 healthy volunteers. The ultrasound measurements will elucidate if ventral hernia~     affects abdominal wall elasticity and effect surgical outcomes.~   "
40006|NCT03043066|"~     To compare the effect of non-surgical periodontal therapy with or without systemic~     administration of amoxicillin and metronidazole on the concentration of serum levels of~     TRAP-5b in patients with generalized chronic periodontitis.~   "
40007|NCT03043053|"~     This is a randomized, double blind, placebo-controlled study of the effects of intranasal~     oxytocin in obese adults, ages 18-45 years old. Subjects will be randomized to receive of~     intranasal oxytocin or placebo (3 sprays per nostril, 4 times per day) for 8 weeks. Study~     visits include screening to determine eligibility, a 2-part baseline visit, and visits every~     2 weeks thereafter until week 14, with a safety follow-up visit 6 weeks after the last dose~     of study drug. Study procedures include behavioral, metabolic, neuroimaging, and endocrine~     assessments.~   "
40008|NCT03043040|"~     This is a multicenter controlled intervention study that aims to assess the efficacy of a~     telephone follow-up program for the prevention of suicidal behavior in adults discharged from~     general hospitals after a suicide attempt.~      The hypothesis is that the implementation of this program is associated with reduced rates of~     suicide reattempts in these patients and also with delayed reattempts in them.~   "
40009|NCT03043027|"~     Percutaneous nephrostolithotomy (PCNL) is a common endoscopic procedure performed for upper~     urinary tract calculus disease. Despite being minimally invasive, it is associated with~     significant postoperative pain, often necessitating inpatient hospitalization and narcotic~     pain medications. Additionally, one of a number of catheters is often left protruding from~     the access tract for a period of time following the procedure, adding to patient discomfort.~     Attempts have been made to study peri-tubular or access tract analgesic installation, which~     have shown promise.1-2 However, no studies, to our knowledge, have examined the use of~     liposomal bupivacaine preparations in this regard. In this study we hope to prospectively~     analyze the use of liposomal bupivacaine injected to the access tract site at the time of~     PCNL and determine its effects on postoperative narcotic requirement and pain scores.~      Patients presenting for PCNL will be randomized to either the liposomal bupivacaine or usual~     care, which involves no injection of local anesthesia. Patients will then be followed during~     their inpatient stay. Total narcotic requirement (in milligrams) and pain scores (using~     Wong-Baker FACES rating scale) will be compared.3 Typical postoperative care and discharge~     criteria will not change during the course of this study.~   "
40010|NCT03043014|"~     Surgical abortion is one of the most frequently surgery of women in the world. 43 millions~     are annually performed in the world.~      90% of the abortions are performed during the first trimester of pregnancy before 13 weeks.~     Legal surgical abortion during the first trimester of pregnancy is a low risk intervention~     with a mortality rate lower than 1/100 000 abortions, with a risk of complications from 0.3 %~     to 3.4 %.~   "
40011|NCT03043001|"~     Since memantine may not only inhibit overactivity of microglial cell, but also repair the~     damaged neurons and neurogenesis through activation of astroglial cell and release of~     neurotrophic factors, the investigators propose that the neurotrophic effect of memantine may~     benefit neurodegenerative diseases including bipolar disorders (BP) and alcohol dependence.~     In the current study, the investigator will investigate whether add-on memantine at a dose of~     5 mg/day has a beneficial effect on BP comorbid with alcohol dependence.~   "
40012|NCT03042988|"~     Patients with autonomic failure are characterized by disabling orthostatic hypotension (low~     blood pressure on standing), and at least half of them also have high blood pressure while~     lying down (supine hypertension). Exposure to heat, such as in hot environments, often~     worsens their orthostatic hypotension. The causes of this are not fully understood. The~     purpose of this study is to evaluate whether applying local heat over the abdomen of patients~     with autonomic failure and supine hypertension during the night would decrease their~     nocturnal high blood pressure while lying down. This will help us better understand the~     mechanisms underlying this phenomenon, and may be of use in the treatment of supine~     hypertension.~   "
40084|NCT03042052|"~     Aims of this study were to assess the long-term outcomes of detrusor injection of~     OnabotulinumtoxinA (Botox® injection) associated with clean intermittent-catheterization~     (CIC) for the treatment of neurogenic detrusor overactivity (NDO) and to identify risk~     factors for failure.~   "
40013|NCT03042975|"~     The contribution of genetic risk factors to the development of focal dystonias is evident.~     However, understanding of how variations in the causative gene expression lead to variations~     in brain abnormalities in different phenotypes of dystonia (e.g., familial, sporadic) remains~     limited. The research program of the investigators is set to determine the relationship~     between brain changes and genetic risk factors in spasmodic dysphonia (or laryngeal~     dystonia). The researchers use a novel approach of combined imaging genetics, next-generation~     DNA sequencing, and clinico-behavioral testing. The use of a cross-disciplinary approach as a~     tool for discovery of the mediating neural mechanisms that bridge the gap from DNA sequence~     to pathophysiology of dystonia holds a promise for the understanding of the mechanistic~     aspects of brain function affected by risk gene variants, which can be used reliably for~     discovery of associated genes and neural integrity markers for this disorder. The expected~     outcome of this study may lead to better clinical management of this disorder, including its~     improved detection, accurate diagnosis, and assessment of the risk to develop spasmodic~     dysphonia in family members.~   "
40014|NCT03042962|"~     Task-specific focal dystonias are characterized by selective activation of dystonic movements~     during performance of highly learned motor tasks, such as writing or playing a musical~     instrument. To date, there is only limited knowledge about the distinct neural abnormalities~     that lead to the development of task-specificity in focal dystonias, which affect similar~     muscle groups but result in different clinical manifestations, such as writer's cramp vs.~     pianist's dystonia or spasmodic dysphonia vs. singer's dystonia. Our goal is to dissect the~     pathophysiological mechanisms underlying the phenomenon of task specificity in isolated focal~     dystonias using multi-level brain network analysis in conjunction with neuropathological~     examination of postmortem brain tissue from patients with dystonia. Rather than viewing these~     disorders as interesting curiosities, understanding the biology of task-specific activation~     of motor programs is central to understanding dystonia.~   "
40015|NCT03042949|"~     An assesment of an optical system that measures blood pressure on the finger -Elfor 1 device.~     The system is based on a small optical sensor that emits coherent light into the skin and~     collects the reflected light from the red blood cells in the blood vessels in the skin under~     the sensor. The sensor is able to detect the pulse wave and blood pressure can be measured.~      The investigators plan to measure blood pressure with the new sensor in patients who are~     attending the Hypertension Clinic at Meir Hospital or are undergoing hemodialysis to validate~     the sensor.~   "
40016|NCT03042936|"~     The purpose of this study is to test the effectiveness of an out-of-school diabetes~     prevention program for youth (ages 7-15) with a family history of pre-diabetes or type 2~     diabetes.~   "
40017|NCT03042923|"~     The objective of this project will be to determine whether patients with a surgical diagnosis~     of endometriosis have impaired intestinal permeability as compared with healthy controls.~     This would suggest the presence of an environmentally triggered and intestinally mediated~     association in the etiology of endometriosis. This would be a proof of concept trial to~     establish whether there is in fact a relationship worthy of future research.~   "
40018|NCT03042910|"~     This study is designed to evaluate the effects of talazoparib on cardiac repolarization in~     patients with advanced solid tumors with no available standard treatment options.~   "
40019|NCT03042897|"~     This pilot clinical trial studies exercise and diet intervention in promoting weight loss in~     obese patients with stage I endometrial cancer. Exercise and diet may cause weight loss and~     minimize the risk of gynecologic surgery related to being overweight in patients with~     endometrial cancer.~   "
40020|NCT03042884|"~     The goal of this research study is to learn how useful a wearable exercise tracker watch is~     to monitor your physical activity.~      This is an investigational study.~      Up to 100 participants will be enrolled in this study. All will take part at MD Anderson.~   "
40021|NCT03042871|"~     The purpose of this study is to compare the efficacy (times of injection, change of visual~     acuity and Cva/ I) and safety (macular visual function and choroidal thickness) of different~     dosing of ranibizumab intravitreal injection (1+PRN vs. 3+PRN) in treating with pathological~     myopia choroidal neovascularization (PM-CNV).~   "
40022|NCT03042858|"~     This will be a multi-center prospective observational study of all patients who undergo~     laparoscopic pyloromyotomy. Subjects who have PPV will be followed up to just before their~     18th birthday through annual phone calls or emails to determine the incidence and timing of~     subsequent inguinal hernia.~   "
40023|NCT03042845|"~     The investigators aim to assess safety and efficiency of Tiger II (5Fr; Terumo Interventional~     Systems, Somerset, New Jersey) vs Judkins (5Fr; 3.5L/4R, Medtronic Co) catheters, in coronary~     angiography via the right transradial route. This is a prospective, randomized, two-centre,~     study of parallel design. Consecutive patients with acute coronary syndrome (ACS), eligible~     for non-urgent coronary angiography, are randomized after successful cannulation of right~     radial artery and informed consent to either Tigger II or Judkins 3.5L/4R catheters.~   "
40024|NCT03042832|"~     This study will test the effects of the Leadership and Organizational Change for~     Implementation (LOCI) intervention in facilitating evidence-based practice (EBP)~     implementation in substance use disorder (SUD) and HIV services settings. LOCI improves~     implementation leadership and organizational support to develop strategic climate for EBP~     implementation. Greater efficiency and effectiveness of EBP implementation will improve the~     public health impact of evidence-based health and allied healthcare innovations and lead to~     greater effectiveness of SUD and HIV services.~      Project Terms:~   "
40025|NCT03042819|"~     This is a phase 1b study of investigational drug selinexor in combination with doxorubicin in~     patients with locally advanced or metastatic soft tissue sarcoma. The purpose of this study~     is to determine how safe and tolerable the combination is, as well as the best dose of the~     study drugs in this patient population.~      Selinexor (also called KPT-330), works by trapping tumor suppressor proteins within the~     cell and thus causing the cancer cells to die or stop growing.~   "
40121|NCT03041571|"~     A qualitative study assessing the impact of early narrative medicine practice on Medical~     Honors Program (MHP) students' attitudes regarding patient-centered interactions, through~     interviewing patients with chronic or life-limiting illnesses to obtain their illness~     stories.~      MHP students will develop a patient narrative for the patients interviewed. These narratives~     will be edited by the patient, and, with the permission of the patients, may be published as~     a collection of stories.~   "
40026|NCT03042806|"~     Patients affected from Chronic Obstructive Pulmonary Disease (COPD) benefit from pulmonary~     rehabilitation in terms of exercise capacity, symptoms and health-related quality of life~     whereas the effect on physical activity is still not clear. Some studies have investigated~     the effect of exercise training on daily physical activity. However, there is considerable~     variability in study findings, data are discordant and the effect of exercise training on~     physical activity is unclear. There are probably a number of reasons to account for this.~      First of all, the choice of the method for evaluating physical activity. Although direct~     observation, double-labelled water and calorimetry are considered the gold standard for~     assessing physical activity, they are too time consuming and expensive to be used in large~     population studies .The Physical Activity (PA) of patients with COPD can be assessed using~     questionnaires. A variety of questionnaires exist that capture different aspects of physical~     activity such as amount, type, intensity, symptom experience and limitations in the~     performance of ''activities of daily life''. Up to now, it still does not exist an instrument~     that evaluates the physical activity of COPD patients in Italian language that takes in~     account Italian people' lifestyle. Since this is strongly influenced by the environment,~     cultural and social conditions in which we live, it is essential to have an instrument~     specifically tailored for the population under study.~      Aim of this study is to validate the Maugeri Physical Activity questionnaire (MaPAct) in COPD~     patients pointing to assess self-perceived physical activity.~   "
40027|NCT03042793|"~     Title: Vaccination with PD-L1 peptide with Montanide against multiple myeloma after high dose~     chemotherapy with stem cell support. A phase I first-in-human study.~      Hypothesis: In this trial the investigators assess a new immunotherapeutic strategy targeting~     the immune checkpoint molecule PD-L1 to investigate the potential of vaccination against~     PD-L1 as a possible anticancer target.~   "
40028|NCT03042780|"~     The purpose of this study is evaluate the efficacy and safety of FOLFIRINOX in patients with~     gastroenteropancreatic high-grade neuroendocrine carcinomas.~      This is a prospective Phase II open-label trial, stratifying gastroenteropancreatic high~     grade neuroendocrine carcinomas participants equally into two cohorts (first-line versus~     beyond first-line).~   "
40029|NCT03042767|"~     The main objective of this pilot study is to evaluate whether 12 weeks of IMM-124E in~     children with nonalcoholic fatty liver disease (NAFLD) in combination with standard of care~     treatment will decrease inflammation in the liver as measured by alanine transaminase (ALT).~     Specifically, investigators will measure percent change in ALT from Week 0 to Week 12 in~     treatment compared to placebo.~   "
40030|NCT03042754|"~     Early diagnosis can contribute to good treatment outcomes and isolate infection control.~   "
40031|NCT03042741|"~     Atherosclerosis vaccine, V6, has been through two small-scale Phase II open label clinical~     trials. It has shown significant improvement in lipid profile in patients with overweight or~     obesity~   "
40032|NCT03042728|"~     In this study the investigators hypothesize that the presence of a Mayo Clinic certified~     therapy dog will provide additional benefits above typical therapy for patients suffering~     from fibromyalgia currently enrolled in the Mayo Clinic Fibromyalgia Program.~   "
40033|NCT03042715|"~     This research study is evaluating a psychological intervention for caregivers of patients~     undergoing stem cell transplantation.~      Phase 1 will include a qualitative phase to refine the intervention to specifically target~     the needs of caregivers~      Phase 2 of the trial will transition to an interventional randomization clinical trial~   "
40034|NCT03042702|"~     Cellceutix has developed Kevetrin (thioureidobutyronitrile), belonging to an~     anti-proliferative p53 activator pharmacological class, for the treatment of cancer.~     Nonclinical studies have demonstrated that Kevetrin induces apoptosis by activation of wild~     type p53 and induces apoptosis in mutant p53 cells by degradation of oncogenic mutant p53.~      In this Phase 2 study, two different short-term treatment regimens of Kevetrin will be~     evaluated for safety, tolerability, changes in biomarkers/objective tumor response, and to~     evaluate the pharmacokinetics of Kevetrin when administered to subjects with~     platinum-resistant/refractory ovarian cancer.~   "
40035|NCT03042689|"~     This research study is studying a drug as a possible treatment for advanced myeloid~     malignancies including AML (acute myeloid leukemia), MDS (myelodysplastic syndrome) and MPN~     (myeloproliferative neoplasms)~      The intervention involved in this study is:~      -Regorafenib (Stivarga)~   "
40036|NCT03042676|"~     Allogeneic hematopoietic stem cell transplantation (HSCT) is capable of definitive cure of~     acute leukemias. The most important post-transplant complication is graft vs host disease~     (GVHD) which can be substantially decreased by the addition of anti-T lymphocyte globulin~     (ATG-Grafalon) to the standard GVHD prophylaxis (cyclosporin and methotrexate) without any~     increase in relapses and infections (Kroger et al NEJM 2016, ClinicalTrials.gov number,~     NCT00678275). In the ATG_familystudy (prospective, randomised, multicenter study) a decrease~     in the incidence of chronic GVHD (from 67.8% to 32.2%) was observed after the addition of ATG~     (10 mg/kg for three days ,from day -3 to -1) to the standard GVHD prophylaxis in the setting~     of acute leukemias in any remission, receiving peripheral blood stem cells from an HLA~     identical sibling donor after myeloablative preparative regimen. In particular, the GVHD~     extensive form was reduced from 52.4% to 7.6%. The study has been closed in 2014 with a~     minimum follow up of 2 years from transplant. The investigators would like to evaluate the~     longer term follow up of this study.~   "
40037|NCT03042663|"~     To evaluate the value of US-guided Stellate ganglion block for improving radial arterial~     blood flow and peripheral perfusion in Septic shock patients on vasopressor support with an~     indwelling radial arterial cannula, which can result in reduced incidence premature failure~     of the catheter (due to vasospasm or thrombosis) and incidence of ischemic complications in~     the cannulated arm.~   "
40038|NCT03042650|"~     The purpose of this study is to determine if Intensive Referral Intervention increases~     motivation to quit cigarette smoking and quitting-related behaviors in probationers and also~     to determine if Intensive Referral Intervention improves short-term substance use outcomes in~     probationers with substance use disorder.~   "
40122|NCT03041558|"~     This project will evaluate the implementation and efficacy of a domestic violence~     intervention module for parents receiving child welfare home visitation services.~   "
40040|NCT03042624|"~     This trial aims at evaluating the efficacy of a fermented rice flour for the treatment of~     atopic dermatitis (AD).~      The fermented rice flour, obtained from Lactobacillus paracasei CBA L74 (Heinz Italia SpA,~     Latina, Italy), does not contain live bacteria. Lactobacillus paracasei CBA L74 belongs to~     the list of microorganisms with qualified presumption of safety compiled by the European Food~     Safety Authority (EFSA), is tested for the absence of antibiotic resistance genes in~     accordance with EFSA, and is genetically characterized by repetitive extragenic palindromic~     polymerase chain reaction.~      Using a repeated-measure cohort design, the investigators have recently shown that the~     administration of a fermented-rice flour obtained from Lactobacillus paracasei CBA L74 was~     associated with a decrease of the score for atopic dermatitis (SCORAD) in children with AD.~      The present randomized, double-blind, controlled trial is aimed at testing whether the~     fermented rice flour obtained from Lactobacillus paracasei CBA L74 is effective in reducing~     SCORAD in children with moderate to severe AD using placebo as comparator.~   "
40041|NCT03042611|"~     The purpose of this study is to evaluate the clinical benefit and safety of Apatinib plus~     Best Supportive Care in comparison to Placebo plus Best Supportive Care in patients with~     advanced or metastatic gastric cancer~   "
40042|NCT03042598|"~     Investigators intend to determine if the use of Biphasic Cuirass Ventilation (BCV) improves~     patient safety (avoiding hypoxia) during emergency rapid sequence intubation .~   "
40043|NCT03042585|"~     Most participants with a relapsed or refractory non-Hodgkin's lymphoma that receive an~     autologous transplant are likely to suffer a relapse because standard myeloablative~     preparative regimens are unable to produce a cure. The majority of these participants do not~     have a stem cell donor available, are too frail to undergo an allogeneic transplant, or~     refuse an allograft. Historically these participants with high risk non-Hodgkin's lymphoma~     have had a very poor outcome.~      To take advantage of the low transplant related mortality associated with an autologous~     transplantation, the investigators propose modifying the preparative regimen to make it more~     effective without increasing toxicity. By increasing the dose of radiation while~     administering the protective growth factor palifermin (Kepivance), the investigators hope to~     decrease the risk of relapse without increasing transplant related mortality.~      Three prospective randomized trials have studied different radiation schemes as a part of the~     TBI and cytoxan preparative regimen prior to allogeneic transplantation for patients with AML~     or CML. As a group these trials showed that higher doses of TBI in these older studies~     decreased the risk of relapse at the expense of VOD, GVHD, and CMV. Three retrospective~     studies have also postulated that higher dose radiation led to less risk of relapse.~   "
40044|NCT03042572|"~     The primary objective of this trial is to investigate whether intramuscular administration of~     allogeneic mesenchymal stromal cells (MSC) is safe and potentially effective, assessed as a~     composite outcome of mortality, limb status, clinical status (Rutherford classification) and~     pain score (visual analogue scale), in patients with no-option severe limb ischemia (SLI).~      The investigators will conduct a double-blind, placebo-controlled randomized clinical trial~     to investigate the effect of allogeneic bone marrow(BM)-derived MSC in patients with SLI, who~     are not eligible for conventional surgical or endovascular therapies. The investigators~     intend to include 60 patients, who will be randomized to undergo 30 intramuscular injections~     with either BM-MSC (30 injection sites with 5*10^6 MSCs each) or placebo in the lower leg of~     the ischemic extremity. Primary outcome i.e. therapy success, a composite outcome considering~     mortality, limb status, clinical status (Rutherford classification) and changes in pain~     score, will be assessed at six months.~   "
40045|NCT03042559|"~     To compare the effect of Protonics knee brace and Hamstring Resisted Exercise (HRE) on~     anterior pelvic tilt, hip internal rotation and adduction, and knee pain in subjects with~     Patellofemoral pain symptoms (PFPS) and examine the reliability and validity of self-report~     patellofemoral disability index (PDI) as a measure of functional performance in subjects with~     PFPS.~   "
40046|NCT03042546|"~     Investigators will compare antibiotic impregnated Calcium sulfate versus PMMA versus nothing~     in these sub-segmental bone defects.~   "
40047|NCT03042533|"~     The investigators will compare the three methods of seating a tibial nail - Backslapping or~     Backslapping with Dynamic Locking or Internal Compression.~   "
40048|NCT03042520|"~     Primary Objective:~      To evaluate the long-term outcomes including liver related morbidity, mortality and~     hepatocellular carcinoma (HCC) development as compared to those of historical control with~     interferon(IFN)-based treatment.~      Secondary Objective:~        1. To access liver fibrosis progression/regression in CHC patients after sofosbuvir-based~          treatment.~        2. To investigate the long-term outcomes of extrahepatic manifestations of the~          sofosbuvir-based treated cohort as compared to their pretreatment status.~   "
40049|NCT03042507|"~     Analysis of data from the recently completed NIH Child Comprehensive Behavioral Intervention~     for Tics (CBIT) study found a manualized behavioral treatment approach strongly superior to~     psychoeducation/supportive therapy for reducing tic severity in 9-16 year-old youths with TS~     or other Chronic Tic Disorders. Buoyed by the success of the NIH study, the research group~     now seeks to extend and disseminate the CBIT treatment through the systematic adaptation of~     the CBIT protocol for use across a broader range of ages and treatment settings.~      The goal of the this project is to develop a downward extension of the CBIT therapist guide~     and parent workbook for use in 4-8 year old children with chronic tics. The revised CBIT-JR~     manual/workbook will be pilot tested in five children at each of the three study sites (UCLA,~     UWM, Weill Cornell) in order to provide initial data regarding treatment feasibility and~     acceptability as well as our ability to implement the new intervention, along with relevant~     quality control procedures, consistently across sites. These pilot data will then be used to~     seek R01 support for a larger controlled multisite trial examining the efficacy of CBIT-JR.~      Although arguably more complex than a single-site design, we have opted for a multsite study~     in order: 1) to take advantage of the established productive collaborative relationship and~     collective expertise in childhood tic disorders and psychosocial treatment development across~     our three sites, 2) to collect the proposed feasibility data in a much shorter period of time~     than otherwise possible, and as noted above 3) to demonstrate the cross-site portability of~     the treatment - which will be necessary if we are to obtain subsequent funding for a~     larger-scale efficacy trial.~   "
40050|NCT03042494|"~     In recent years, the importance of the gut microbiota to human health has been demonstrated.~     In adulthood, the microbial profile is relatively stable, yet can be transiently altered by~     factors such as diet or antibiotic treatment. Such changes may be beneficial, as gut~     microbiota has been shown to differ in normal versus disease states including inflammatory~     bowel disease, obesity, type 2 diabetes and fatty liver disease. Given this relationship,~     there is intense interest in designing interventions that positively influence the gut~     microbial profile. Prebiotics are non-digestible, fermentable oligo- and polysaccharides that~     alter the colonic environment in favour of health-promoting bacterial species, such as~     bifidobacteria which selectively ferment prebiotics. Given the ability of prebiotics to~     beneficially alter the microbial profile, there is a need to identify the dosing requirements~     to positively modulate the gut microbiota. This study will test the effect of two doses of~     prebiotic on gut microbiota taxonomy and diversity.~   "
40051|NCT03042481|"~     Pegylated-interferon (Peg-IFN) α-2a, entecavir (ETV) and tenofovir disoproxil fumarate (TDF)~     are current recommended first-line antiviral therapies for chronic hepatitis B (CHB).~     Compared with Peg-IFN therapy, nucleot(s)ide analogue (NUC) therapy has the advantages of~     having a potent antiviral effect, and good tolerance without side effect. The long-term~     safety and efficacy of ETV and TDF therapy had also been identified. However, poor durability~     of the effectiveness after stopping NUC therapy are encountered in the majority of patients.~     Previous study identified a high HBV relapse rate of over 50% in HBeAg- positive CHB patients~     treated with lamivudine. A recent study investigating the post-treatment durability of ETV~     showed that higher to 45.3% of the HBeAg-negative CHB patients happened a clinical relapse~     within 1-year after stopping ETV therapy. TDF is another recommended first line NUC with high~     potency and high genetic barrier. Although the efficacy of long-term TDF therapy had been~     identified, there is lack of data regarding the off-therapy response in CHB patients with TDF~     therapy currently. Only a small scale of patients treated with TDF were included in a recent~     study investigating off-therapy relapse in non-cirrhotic HBeAg-negative CHB patients after~     greater than 4 years of NUC therapy. In addition, the factors associated with off-therapy~     response are also still uncertain.~      The investigators plan to enrolled 400 CHB patients who had received oral antiviral therapy~     ETV or TDF and achieved the Asia Pacific association of the study of liver (APASL) criteria~     of stopping NUC therapy. The aims of the study are to investigate the rate of HBV relapse~     including virological and clinical relapse in all and between patients with ETV and TDF~     therapy, and to identify the predictive factors of relapse.~   "
40052|NCT03042468|"~     The purpose of this study is to find the highest dose level of the study drug, 177Lu-PSMA-617~     that can be given without severe side effects for advanced prostate cancer.~   "
40053|NCT03042455|"~     This study was designed to establish the clinical evidence for effect of Robot-Assisted upper~     arm training and Repetitive Transcranial Magnetic Stimulation on upper limb function of~     subacute stroke patients.~        -  Purpose : to elucidate the effect of Robot-Assisted upper arm training and Repetitive~          Transcranial Magnetic Stimulation on upper limb function of stroke patients compared to~          conventional occupational therapy~        -  Subjects : total 99 patients with stroke whose upper limb functions are impaired~        -  Intervention : 4 weeks of therapy (5 days per week)~        -  Studies : upper limb functional assessment (FMA, MFT, WMFT), computerized motion~          analysis~        -  Evaluation plan : 1) pre-intervention, 2) post-2 weeks of intervention, 3) post-4 weeks~          of intervention, 4) 4 weeks after end of intervention~   "
40054|NCT03042442|"~     The purpose of this study is to determine the interrelationship between cachexia, neural~     invasion and diabetes in patients with pancreatic cancer. Thus the investigators propose to~     identify the protein expression levels of Activin and Midkine in plasma of patients with~     different stages of pancreatic adenocarcinoma compared with healthy patients and to evaluate~     the possible correlation with diabetes, tumor size and tumor stage.~   "
40055|NCT03042429|"~     Improvement of event free survival of high-risk neuroblastoma patients by introduction of two~     additional topotecan containing chemotherapy cycles into the multimodal standard treatment~     (induction chemotherapy, myeloablative therapy, radiation, surgery as indicated, and~     consolidation therapy).~   "
40056|NCT03042416|"~     Single centre prospective cohort phase III study of 18F-DOPA PET/CT imaging in specific~     patient populations:~        1. Pediatric patients with congenital hyperinsulinism~        2. Pediatric patients with neuroblastoma~        3. Pediatric or Adult patients with suspected extra-pancreatic neuroendocrine tumor~        4. Adult patients with a clinical suspicion of Parkinson's disease~        5. Pediatric or Adult patients with primary brain tumors~      This study will evaluate the biodistribution and safety of 18F-DOPA produced at the Edmonton~     PET Centre.~   "
40057|NCT03042403|"~     This study aims to Analyze and compere the hemodynamic and respiratory variables before,~     during and after the applying of technic as well as evaluate respiratory pressures generated~     during applying of this same technic and correlate them with the effort noticed by device~     user.~   "
40058|NCT03042390|"~     This is a retrospective observational study of patients who have taken a regimen containing~     DRV / c at least 24 weeks prior to study initiation~   "
40059|NCT03042377|"~     The purpose of this randomized clinical trial was to evaluate the incidence of postoperative~     pain after retreatment using different techniques. Patients whom need retreatment were~     included. The presence of postoperative pain was assessed after retreatment cases at 1, 6,~     12, 24 and 48 hrs.~   "
40060|NCT03042364|"~     This study investigates the impact of endometrial scratching on endometrial secretion, when~     correlated to pregnancy.~   "
40061|NCT03042351|"~     Non invasive study to improve the urinary incontinence, through pelvic floor muscles~     exercises~   "
40062|NCT03042338|"~     Feasibility study of Central Executive Training (CET) for ADHD. The goal of the current~     project is to develop and assess the feasibility, acceptability, engagement, and usability of~     a novel, central executive (CE) working memory training intervention.~   "
40063|NCT03042325|"~     The purpose of this study is to evaluate the safety and efficacy of alogliptin tablets when~     given as monotherapy or add on therapy in participants who are on standard care for~     management of Type 2 Diabetes Mellitus (T2DM).~   "
40064|NCT03042312|"~     Studies will assess safety and efficacy of 177Lu-PSMA-617 in patients with metastatic~     castration resistant prostate cancer.~   "
40066|NCT03042286|"~     To find out the pharmacokinetic and genetic risk factors involved in muscular side effects~     (myalgia) associated with statin therapy. To learn better ways of identifying risk factors~     associated with muscle side effects during statin therapy. To perform laboratory analysis to~     identify factors predicting future outcomes. The genetic material, in combination with other~     medical information and blood tests, will be available to researchers studying genetic and~     other factors that contribute to myalgia caused in some patient population on statin~     medication.~      Patients on statin are selected for this study. This study will recruit 1500 subjects from~     National heart Centre Singapore over a period of 2.5 years.~      Participation in the full study includes the donation of genetic material. However, subjects~     have the option of not having blood subjected to genetic analysis and still participate in~     the study. In this case, blood samples will only be analyzed for the statin drug content.~   "
40067|NCT03042273|"~     This clinical trial is a Phase 2, multicenter, placebo-controlled, double-blind, parallel-arm~     study to evaluate the efficacy and safety of High Strength Cranberry (500mg Pacran®) in~     preventing UTI (cystitis) in women with a history of recurrent UTI (rUTI).~   "
40068|NCT03042260|"~     The purpose of this study is to determine whether trimethoprim/sulfamethoxazole is effective~     in preventing serious infectious complications (those that require hospitalization or lead to~     death) in patients with lupus erythematosus that receive intermediate or high dose steroids.~   "
40069|NCT03042247|"~     According to the most recent guidelines, total-body imaging techniques are an indispensable~     element in the staging and post-treatment re-evaluation in patients with lymphoma.~     Fluorodeoxyglucose-positron emission tomography/computed tomography (FDG-PET/CT) is the~     gold-standard for the assessment of the disease in these patients. The use of alternative~     methods, without radiation, such as whole-body magnetic resonance imaging (MRI), could be a~     valid alternative; this would result an advantage, considering the young age of the majority~     of patients at diagnosis and the need to undergo to serial assessments. The recent~     introduction of combined PET total body MRI (PET/MRI) offers the possibility to integrate~     morphological information with the high resolution of MRI with the metabolic activity of PET,~     through the uptake of FDG, for a more accurate definition of the extent of disease in~     patients with lymphoma.~   "
40070|NCT03042234|"~     According to the literature, high-intensity interval training (HIIT) emerges as a potential~     training strategy capable of promoting positive adaptations to the health of obese children~     and adolescents, as it demands less execution time (less volume) and can be considered~     motivationally, More attractive to this audience. However, few studies have adopted the~     anaerobic threshold concept and high intensity interval cardiorespiratory training to~     evaluate the oxidation of energetic substrates during and after physical activity in obese~     adolescents with and without insulin resistance.~      In this context, this study aims to analyze the effects of high intensity interval training~     on lipid and glycemic profile, cardiorespiratory parameters, metabolism of substrates, and~     functional capacity of obese adolescents with and without insulin resistance.~   "
40071|NCT03042221|"~     A comparison of baseline tumor characteristics in oncogene-driven cancers to tumor~     characteristics after early response to Tyrosine Kinase Inhibitor (TKI) targeted treatment~     will allow identification of early adaptive mechanisms of cell survival. This will facilitate~     targeting and termination of these survival/ resistance pathways before they develop with~     rational combinations of therapeutic agents to improve outcomes.~   "
40072|NCT03042208|"~     Research suggests that when one spouse loses weight, the other spouse does too. This study~     will examine whether a ripple effect is observed in untreated spouses and children of~     individuals participating in a nationally available weight loss program. Participants will be~     randomly assigned to either receive Weight Watchers immediately or at the end of a 6-month~     waiting period. Participants and untreated spouses (and any children in the home) will be~     assessed at baseline, 3, and 6 months.~   "
40073|NCT03042195|"~     The purpose of the study is to examine whether postoperative nutrition with endeavours of~     100% coverage of the patient's estimated energy and protein needs, can reduce the incidence~     of postoperative complications.~   "
40074|NCT03042182|"~     Cholangiocarcinoma (CCA) is a malignant neoplasm originating from the epithelial cells lining~     the intra- or extrahepatic biliary ducts. It is the second-most common liver cancer, after~     hepatocellular carcinoma (HCC). About 6,000 people in the United States develop bile duct~     cancer each year. One-year survival is less than 25% and no effective and safe systemic~     treatments are currently available. Last year the completion of open-label phase 2 trial~     (NCT02256514) of hepcortespenlisimut-L (V5) has been reported, which has shown that two-third~     of Mongolian patients with advanced HCC had a favorable clinical response, including complete~     remissions and with overall survival over 90% after 1 year. So far a few patients with CCA~     were treated with V5, but it appeared that their response rate was somewhat inferior to~     patients with HCC since two (both with hemochromatosis) out six patients died within 6~     months. In one patient who had improved clinically, the improvement was correlated with~     decrease in CA19-9 tumor marker, but no marker profile information is available in regard to~     other CCA patients. As V5 tablets are made from pooled blood of patients with HCC, in theory,~     they will be not very useful to patients with CCA. The goal of this project is to manufacture~     an immunotherapeutic formulation made from pooled heat- and chemically-inactivated blood from~     donors with CCA and initiate pilot open-label trial in 20 cholangiocarcinoma patients. This~     clinical trial will be conducted in collaboration with the National Cancer Center.~   "
40093|NCT03041935|"~     Surgical intervention to treat undescended testis is a very common pediatric surgical~     procedure, often performed using an inguinal incision or subscrotal incision approach.~     Children who undergo orchiopexy can suffer from a significant degree of discomfort~     postoperatively. The investigators are evaluating the effectiveness of an ultrasound guided~     caudal-epidural (CE) block to an US guided ilioinguinal/iliohypogastric (IIG/IHG) nerve block~     in achieving post operative analgesia following a orchiopexy repair. It is hypothesized that~     US guided IIG/IHG nerve block leads to more effective pain control post-operatively while in~     hospital relative to an US guided CE block for orchiopexy surgery.~   "
40094|NCT03041922|"~     Estimation of Changes in Soft Tissues Elasticity in Buttocks in lying down and sitting~     positions by using ultrasound device. the elasticity of fat and muscle tissues will be~     measured.~      May ultrasound exam helps to predict the development of pressure ulcers in buttocks due to~     continuous sitting.~   "
40075|NCT03042169|"~     Due to the late onset of symptoms, gastric cancer is frequently diagnosed at an advanced~     stage and therefore in an incurable situation.~      Standard treatment for these patients is palliative chemotherapy, combining 2 or 3 drugs~     (Wagner et al) However chemotherapy efficacy remains insufficient, while exposing patients to~     severe toxicity.~      Taking into account the low complication rates of gastric surgery today, chemotherapy alone~     therefore may not be sufficient for stage IV gastric cancer patients.~      The purpose of palliative gastrectomy is to relieve the symptoms associated with cancer, to~     prevent subsequent tumour complications which are likely to occur, and to improve quality of~     life. In addition reducing the tumour burden, may be associated with a prolonged survival~     time.~      This study is designed as a multicentre trial. Patients with diagnosis of a primary stage IV~     gastric adenocarcinoma who are willing to participate in the trial will be randomized to the~     surgical (gastric resection with peri-operative chemotherapy) or the control (chemotherapy~     only) group.~      Primary objective will be overall survival and secondary objectives will be quality of life,~     progression free survival, surgical related postoperative morbidity and mortality,~     chemotherapy related toxicities, overall duration of hospitalization and number of~     interventional palliative procedures~   "
40076|NCT03042156|"~     Immunotherapy includes a class of medication called checkpoint inhibitors, which are a~     relatively new medication therapy for many types of cancer which are metastatic, meaning it~     has spread to other parts of the body.Immune therapy medication may be given safely with~     radiation treatment, and in rare cases it may even make radiotherapy more effective. When~     radiation therapy is given in the palliative setting it is given to treat pain/discomfort~     and not necessarily shrink or get rid of the tumour. Palliative radiotherapy may be given for~     many reasons, but common examples include painful bone or liver tumours, brain metastases, or~     symptoms from a chest tumour such as feeling breathless, cough, or bleeding. Palliative~     radiotherapy is usually given in smaller amounts and less frequently than other types of~     radiation therapy. Because checkpoint inhibitors are relatively new there is not a huge~     amount of evidence looking at how patients respond when the treatments are combined, or in~     which patients immune therapy may make radiation therapy even more effective. This study is~     looking at the way patients who are on or about to start immune therapy and who have been~     recommended for palliative radiotherapy, respond to the combination of these two treatments.~      The purpose of this study is to describe the treatment outcomes in patients with cancer that~     has spread who are managed with a combination of immune therapy medication and radiotherapy.~     This research is being done because there is limited information about the outcomes of~     combined immune therapy and radiotherapy treatment from a patient's perspective, but also in~     terms of which patients may have a better response to combined treatment. In particular, the~     study aims to describe how combined treatment affects cancer not only in the area where~     radiotherapy is given, but also outside the part of the body that receives radiotherapy~     (which is called abscopal effect).~   "
40077|NCT03042143|"~     Acute Respiratory Distress Syndrome (ARDS) causes the lungs to fail due to the collection of~     fluid in the lungs (pulmonary oedema). ARDS is common in severely ill patients in Intensive~     Care Units and is associated with a high mortality and a high morbidity in those who survive.~     There is a large economic burden with direct healthcare costs, but also indirectly due to the~     impact on the carer and patient through the patients inability to return to full time~     employment. There is little evidence for effective drug (pharmacological) treatment for ARDS.~     There is increasing information that mesenchymal stem cells (MSCs) might be important in~     treating ARDS. REALIST will investigate if a single infusion of MSCs will help in the~     treatment of ARDS. The first step will be to first of all determine what dose of MSCs is safe~     and then divide patients suffering from ARDS into two groups, one of which will get MSCs and~     the other a harmless dummy (or placebo) infusion, who will then be followed up to determine~     if lung function improves. If effective this may lead to further research to determine if~     MSCs are effective in patients with ARDS. This project will also provide new information~     about mechanisms in the development of ARDS leading, potentially, to other new treatments~   "
40078|NCT03042130|"~     Patients with congestive heart failure, grade 3-4, in addition to the standard care, will be~     randomized 1:1. The study group will receive 2 doses of IV iron (Iron carboxymaltose). The~     control group will receive standard of care alone. The study will test for the effects of the~     additional IV iron on the symptoms, clinical picture and quality of life of the treated~     patients.~   "
40079|NCT03042117|"~     Cardiovascular disease is one of the leading causes of death in the United States and the~     world. Many interventions relating to prevention have been emphasized as more risk factors~     for this devastating disease are discovered. Periodontal disease is known to have a close~     association with cardiovascular disease, but its role as a risk factor is still not well~     understood. Inflammation is a driving force in both of these diseases, creating a potential~     bridge between the two. Specifically, periodontal disease can cause an inflammatory reaction~     in the body, which may predispose or even directly contribute to atheroma formation in the~     coronary arteries. In this study, the investigators will study the link between the~     inflammatory state of the body and will search for a correlation with levels of coronary~     artery disease and periodontal disease. Inflammatory markers such as high-sensitivity~     C-reactive protein (hs-CRP), erythrocyte sedimentation rate (ESR), and immunoglobulin G (IgG)~     levels in the patient's blood will be analyzed and correlated to clinical attachment loss~     measured via pocket depth measurement, the distance from the gingival margin to the base of~     the pocket. A definitive link between these disease processes will allow preventive measures~     to be taken earlier to prevent this lifelong disease.~   "
40080|NCT03042104|"~     This clinical trial is a prospective, randomized, controlled, multi-center study. Patients~     will be randomized 1:1 to receive either transcatheter aortic valve replacement (TAVR) with~     the Edwards SAPIEN 3 THV or clinical surveillance. Patients will be stratified by whether or~     not they are able to perform a treadmill stress test. Patients who have a positive stress~     test will be followed in a registry to collect data on subsequent treatment and mortality, as~     applicable.~   "
40081|NCT03042091|"~     This randomized clinical trial studies how well neomycin and metronidazole hydrochloride with~     or without polyethylene glycol work in reducing infection in patients undergoing elective~     colorectal surgery. Polyethylene glycol, may draw water from the body into the colon,~     flushing out the contents of the colon. Antibiotics, like neomycin and metronidazole~     hydrochloride, may stop bacteria from growing. It is not yet known whether it's better to~     give preoperative neomycin and metronidazole hydrochloride with or without polyethylene~     glycol in reducing surgical site infection after colorectal surgery.~   "
40082|NCT03042078|"~     This study is aimed to compare the feasibility, safety and efficacy of a zero-fluoroscopic~     approach using Ensite NavX with conventional fluoroscopic approach using Ensite NavX plus~     fluoroscopy for the ablation of paroxysmal supraventricular tachycardia.~   "
40083|NCT03042065|"~     Controlled trial of nebulized salbutamol using jet nebulizer or vibrating mesh technology in~     children presenting with acute moderate to severe asthma.~   "
40085|NCT03042039|"~     CareWell will enable the delivery of integrated healthcare to frail elderly patients in a~     pilot setting through comprehensive multidisciplinary integrated care programmes where the~     role of ICTs can foster the coordination and patient centered delivery care. Carewell will~     focus in particular complex, multi-morbid elderly patients, who the patients most in need of~     health and social care resources (35% the total cost of Health Care System) and more complex~     interventions due to their frailty and comorbidities (health and social care coordination,~     monitoring, self-management of the patient and informal care giver). ICT platforms and~     communication channels that allow sharing information between healthcare and social care~     professionals involved in the delivery care of these patients, facilitating their~     coordination, increasing their resoluteness and avoiding duplicities when tackling patients´~     diagnostic, therapeutic, rehabilitation or monitoring needs. Additionally, ICT-based~     platforms can improve the adherence to treatment, enhance self-care and increase patient~     awareness about their health status , as well as, improve the empowerment of informal~     caregivers, who usually take care of these patients.~      According to this, it is hypothesized that the benefit of integrated care programmes based on~     (1) integrated care coordination and (2) patient empowerment & home support pathways~     supported by ICT is greater and essential for these patients. Care pathways will cut across~     organisational boundaries and will activate the most appropriate resources across the entire~     spectrum of healthcare and social care services available for both scheduled and emergency~     care. CareWell aims to scale up the services in pioneer regions and share their approach,~     learning from and supporting the other pilot sites which are at different levels of maturity~     in respect to designing, developing and implementing new ways of providing integrated care~     services.~   "
40086|NCT03042026|"~     We will compare the features of 3D stereophotography of acromegaly patients with that of~     healthy people. We hope to develop a computerized model to help screening acromegaly patients~     for early detection and treatment.~   "
40087|NCT03042013|"~     The purpose of the study is to evaluate long-term safety and tolerability of continuous~     treatment with ASP8273 in subjects who are participating in an Astellas-sponsored ASP8273~     study which has completed, at a minimum, the primary analysis or have completed the~     individual study evaluation period and for whom the investigator feels the subject may have~     potential to continue to derive clinical benefit from treatment with ASP8273.~   "
40088|NCT03042000|"~     At present, the combined modality treatment of preoperative neoadjuvant chemoradiotherapy~     (NCRT) followed by radical surgery has become the standard of care for the locally advanced~     mid/low rectal cancer, having been proved to substantially improve the local control of the~     disease, whereas not being able to improve the long-term survival. According to present~     clinical practice guidelines, all patients with cT3-4N0M0 or cTanyN1-2M0 mid/low rectal~     cancer are recommended to undergo the preoperative long-term radiotherapy with concurrent 5FU~     based chemotherapy, followed by the radical resection of the tumor. After surgery, adjuvant~     chemotherapy (ACT) is recommended for all these patients without considering the~     postoperative pathological results. Recently, however, some authors proposed that different~     strategy of combined modality therapy should be applied in different patients according to~     their risk of relapse, instead of using the uniform NCRT strategy. In this research, on the~     basis of investigator's previous clinical practice and researches, investigators plan to~     stratify the patients with cT3-4N0M0 or cTanyN1-2M0 mid/low rectal cancer into several~     subgroups according to tumor stages and the risk of relapse. Different therapeutic strategy~     will be applied in different groups, at the aim of improving the overall therapeutic effects,~     as well as reducing the treatment adverse effects.~      This research consists of four trials.~   "
40089|NCT03041987|"~     This study aimed to explore underlying mechanisms of chronic kidney disease progression and~     its association with adverse consequences. It will enroll approximately 5000 pre-dialysis~     chronic kidney disease patients aged between 18 and 74 years in mainland China and follow-up~     for at least 5 years. Questionnaires, anthropometric measures, laboratory tests, and~     biomaterials will be collected at baseline and annually. The principal clinical outcomes of~     the study consist of renal disease events, cardiovascular events, and death.~   "
40090|NCT03041974|"~     During storage, red blood cells (RBCs) undergo changes collectively termed Storage lesions.~     these changes may have an impact of the outcomes of transfused patients. One of these changes~     is the release of microparticles by RBCs and other blood cells types. The aim of the study is~     to (1) quantify red cell- and platelet-derived microparticles in RBC concentrates, and (2)~     evaluate the impact of transfused microparticles (MPs) on survival and post-transfusion~     complications in critical care patients participating in the ABLE trial (ISRCTN44878718).~   "
40091|NCT03041961|"~     There is an increasing interest in the effects of various food derived polyphenols on~     vascular function. Arguably the most well-established vascular benefits are attributed to~     flavanols from cocoa beans and this has been supported by a successful health claim through~     the European Food Safely Authority in 2012. Berry fruits are another rich source of~     polyphenols that have vasoactive properties, and there is a growing body of research~     exploring these effects in various berries (blueberries, cranberries, strawberries) and other~     fruit products with similar polyphenol composition. A key (poly)phenol in berries and other~     fruits believed to provide much of the benefit is anthocyanins. When given as an isolated~     extract, 320 mg anthocyanins have been found to improve blood vessel function both acutely~     and in response to chronic consumption over 12 weeks.~      Aronia berries are a native North American berry with high naturally occurring anthocyanins~     among other polyphenols. Based on their polyphenol composition, there is growing interest in~     the potential for Aronia berries to elicit health promoting cardio-metabolic effects.~     Specifically, Aronia berry extracts, which provide a concentrated source of polyphenols, may~     improve blood vessel function.~      Thus, the primary focus of this project is to evaluate the effects of Aronia berry extracts~     of differing polyphenol dose on vascular endothelial function.~   "
40092|NCT03041948|"~     Surgical intervention to treat a inguinal hernia is a very common pediatric surgical~     procedure, often performed using an inguinal incision. Children who undergo hernia repair can~     suffer from a significant degree of discomfort postoperatively. The investigators are~     evaluating the effectiveness of an ultrasound guided caudal-epidural (CE) block to an US~     guided ilioinguinal/iliohypogastric (IIG/IHG) nerve block in achieving post operative~     analgesia following a hernia repair. It is hypothesized that US guided IIG/IHG nerve block~     leads to more effective pain control post-operatively while in hospital relative to an US~     guided CE block for inguinal hernia surgery.~   "
40095|NCT03041909|"~     This is an open label, single arm study which will enroll up to 16 subjects with SCD who~     previously participated in the GBT440-001 study.~      Dosing of study drug will be for 2 to 6 months, depending on subject's dose assignment in the~     last administration of study drug in GBT440-001.~      The primary objective of the study is to evaluate the safety and tolerability of up to a~     total of 6 months dosing of subjects with SCD who participated in the GBT440-001 study.~   "
40098|NCT03041870|"~     Previous studies have already revealed the involvement of the serotoninergic system in the~     social behavior process. For example, more serotonin (5HT) was found in dominant male adult~     monkeys. Little is known about the serotoninergic implication in human's social behavior. The~     project aims to clarify the role of the serotoninergic system in social behavior in relation~     to the process of social hierarchical information. In order to determine how serotoninergic~     system is involved, the investigator will use a new technic TEP-fMRI. This technic allows us~     to measure the brain activity and the serotoninergic transporter occupancy (using the~     [C11]-DASB) at the same time. The current study aims to investigate whether serotonin~     transporter (5-HTT) activity correlates with the neural response (BOLD) during the detection~     of social dominance in facial expressions or other measures of social information processing.~     Blood sample, SLC6A4 (allele coding for the 5HT transporter) genotyping and~     neuropsychological questionnaires will give at the investigator more information and allow to~     investigate whether performance on social information processing is modulated by personality~     trait and genotype.~   "
40099|NCT03041857|"~     The objective of this research project is to perform a comparative study on the in vivo~     kinematics of the GMK Sphere prosthesis in comparison to the conventional GMK PS Fixed~     Bearing TKA as well as to the GMK UC Mobile Bearing during level walking, stair descent and~     downhill walking by means of videofluoroscopy.~   "
40100|NCT03041844|"~     The purpose of this study is to evaluate the effect of low frequency, low intensity~     ultrasound treatment on wound healing and health-related quality of life with a randomized~     clinical trial of patients with venous ulcers or diabetic ulcers.~   "
40101|NCT03041831|"~     This qualitative study seeks to assess whether mobile health technologies are helpful for~     older adults. It is the first in a series of four studies whose overarching goal is to~     conduct a program of pilot research aimed at developing and evaluating a technology-assisted~     wellness intervention for older adults with obesity who may or may not live in a rural area.~   "
40102|NCT03041818|"~     The purpose of this study is to develop healing riding algorithm applicable in rural riding~     centers and to apply this to children with cerebral palsy.~   "
40103|NCT03041805|"~     The aim of the study is to make a validation of Caprini score in patients undergoing varicose~     veins surgery, especially endovascular procedures (endovascular laser treatment - EVLT,~     radiofrequency ablation - RFA, ultrasound-guided foam sclerotherapy - USFS) and to identify~     patients with elevated risk of postoperative venous thromboembolism (VTE) who will benefit~     from prophylactic anticoagulation.~   "
40104|NCT03041792|"~     This will be a randomized, double blind, placebo controlled, 2 arm, parallel group,~     methodology study to assess the effect of 6 weeks of liraglutide administration on food~     intake in obese subjects.~   "
40105|NCT03041779|"~     To assess the prevalence of pain score for perineum pain following childbirth followed by~     phase 2 study to assess the analgesic effectiveness of acetaminophen and diclofenac rectal~     suppository in postpartum perineum pain secondary to perineal trauma.~   "
40106|NCT03041766|"~     The clinical trial phase 2a is designed to assess the safety of the active ingredient~     (protein + adjuvant) and secondarily its immunogenicity in healthy male adults from 18 to 49~     years of age with a history of infection with intestinal and urinary schistosomiasis, living~     in the Valley of the Senegal River, a highly endemic area for schistosomiasis. Two arms in~     the study will test different doses of GLA-SE adjuvant (2.5 and 5 μg). This phase IIA in~     adults is considered to be a preliminary step in safety before starting trials in children in~     endemic areas to S. mansoni or S. haematobium, target population of the vaccine.~   "
40107|NCT03041753|"~     Background: stroke is a major cause of death and disability. Intravenous thrombolysis and~     mechanical thrombectomy are able to re-open occluded vessels and save the ischemic tissue~     from death. However, recanalization of the occluded vessel may trigger activation of~     detrimental molecular pathways and exacerbate blood brain barrier (BBB) disruption,~     eventually determining hemorrhagic transformation (HT) or cerebral edema (CE), causing the~     so-called reperfusion injury. There is increasing evidence that a number of factors~     measurable as circulating biomarkers, particularly metalloproteinases (MMP), contribute to~     reperfusion brain injury. Preliminary data show that BBB disruption can be traced in vivo by~     Computed Tomography Perfusion (CTP) imaging. The aim of this study is to evaluate the effects~     of circulating and imaging biomarkers in relation to reperfusion injury.~      Methods: consecutive patients presenting with acute ischemic stroke in the anterior~     circulation territory, scoring≥7 on NIHSS, candidates to intravenous thrombolysis or to~     endovascular treatment, will be enrolled in one hospital centre. Circulating levels of pro-,~     anti-inflammatory, immunomodulatory factors, metalloproteinases and their~     inductors/inhibitors, factors of endothelial dysfunction and fibrin resistance to lysis will~     be measured in blood samples taken from each patients pre-thrombolysis and 24 hours after~     thrombolysis. Biomarker levels will be studied in relation to CTP measures of BBB~     permeability and in relation to imaging signs of reperfusion injury after acute~     interventions, such as hemorrhagic transformation and cerebral edema.~      Results: enrollment started on October 2015. As of January 2017, 70 patients have been~     included. Results are expected by the end of 2018 with an estimated sample size of 140~     patients. Using a definite protocol, a prospective collection of data, and an adequate number~     of patients assuring statistically powered data, this study will integrate clinical~     information with imaging and biological factors involved in reperfusion injury after cerebral~     ischemia.~   "
40108|NCT03041740|"~     The primary study objective is to assess the safety and feasibility of PFOB as a liquid~     breathing medium for up to ten days in subjects with severe Bronchopulmonary Dysplasia (BPD).~   "
40109|NCT03041727|"~     The study purpose is to compare the effects of Fascial Manipulation added to standard~     exercises protocol versus the simple exercises protocol.~   "
40118|NCT03041610|"~     A multicenter randomized controlled trial, with follow-up at 6 and 12 months. Physically~     inactive participants with chronic heart failure with reduced ejection fraction will be~     randomly assigned to intervention or control arms.~      The six-month intervention will consist of an individualized pedometer-based walking program~     with weekly step goals, monthly face-to-face sessions with the physician, and monthly~     telephone calls with the research nurse. The intervention will be based on effective~     behavioral principles (goal setting, self-monitoring, personalized feedback).~      The primary outcome is the change in 6-minute walk distance at 6 months. Secondary outcomes~     include changes in serum biomarkers levels, pulmonary congestion assessed by ultrasound,~     average daily step count measured by accelerometry, anthropometric measures, symptoms of~     depression, health-related quality of life, self-efficacy, and MAGGIC Risk Score.~   "
40119|NCT03041597|"~     To prospectively monitor the survival rate of Ankylos® dental implants, comparing delayed~     versus immediate loading, using abutments with the SynCone® concept for implant-supported~     detachable dental prosthesis (ISDDP) in the edentulous upper jaw.~   "
40120|NCT03041584|"~     To assess implant outcomes, both clinical and radiological, in a randomized study on guided~     implant placement after 3-year follow-up, compared to non-guided treatment.~   "
40110|NCT03041714|"~     Background:~      Essential tremor is when a person has tremor, but no other neurological symptoms. Dystonic~     tremor is when a person also has dystonia. Dystonia is a condition in which muscle~     contraction causes changes in posture. Researchers do not fully know what areas of the brain~     cause these tremors, or how the types differ. They also do not know what tests can identify~     the differences.~      Objective:~      To look at differences between essential tremor and dystonic tremor.~      Eligibility:~      People ages 18 and older with or without tremor~      Design:~      Participants will be screened with medical history, physical exam, and urine tests. Those~     with tremor will complete questionnaires about how tremor affects them.~      The screening and study visits can be done on the same day or on separate days.~      Participants will have 1 or 2 study visits. These include magnetic resonance imaging (MRI)~     and tremor testing.~      For MRI, participants will lie on a table that slides in and out of a cylinder that takes~     pictures. Sensors on the skin measure breathing, heart rate, and muscle activity. This takes~     about 2 hours.~      Tremor testing will include transcranial magnetic stimulation (TMS), electrical stimulation~     of the fingers, doing a movement task, and recording of tremor movements. For TMS, two wire~     coils will be held on the scalp and a brief magnetic field will be produced. A brief~     electrical current will pass through the coils. For the other tests, small sticky pad~     electrodes will be put on the skin. Participants will move their hand when they hear a sound.~     They will get weak electrical shocks to their fingers. These tests will take 3-4 hours.~      Participants can take part in either or both parts of the study.~   "
40111|NCT03041701|"~     Background:~      Rhabdomyosarcoma (RMS) is the most common soft tissue sarcoma of childhood. Two types are~     embryonal RMS (ERMS) and alveolar RMS (ARMS). Dasatinib may block over-expression of a~     certain enzyme. Ganitumab may block a certain growth factor, which might suppress tumor~     growth. This drug combination may help slow tumor growth in people with ERMS and ARMS.~      Objective:~      To see if dasatinib combined with ganitumab is safe and shrinks or slows the growth of tumors~     in people with ERMS and ARMS.~      Eligibility:~      People any age who have ERMS or ARMS that did not respond to previous treatment and who can~     swallow tablets~      Design:~      Participants will be screened with:~        -  Medical history~        -  Physical exam~        -  Blood, urine, and heart tests~        -  Scans/x-rays~        -  Tissue sample: This can be from previous surgery or biopsy.~        -  Optional biopsy: A small piece of the tumor is removed with a needle.~      Participants will be asked to co-enroll in another protocol.~      Participants will get a drug interaction handout and wallet card that show what foods and~     medications to avoid.~      Participants will be treated in cycles. The first cycle is 35 days and the rest are 28 days.~     Participants will take dasatinib by mouth daily. They will get ganitumab through an IV every~     2 weeks. They will have a physical exam every 1-2 weeks, and urine and heart tests before~     most cycles.~      Participants will continue treatment as long as they do not have severe side effects or their~     tumors do not get worse.~      After ending treatment, participants will have a visit. This includes repeats of the~     screening tests.~   "
40112|NCT03041688|"~     This phase Ib trial studies the side effects and best dose of murine double minute chromosome~     2 (MDM2) inhibitor AMG-232 when given together with decitabine in treating patients with~     acute myeloid leukemia that has come back, does not respond to treatment, or is newly~     diagnosed. MDM2 inhibitor AMG-232 may stop the growth of cancer cells by blocking some of the~     enzymes needed for cell growth. Drugs used in chemotherapy, such as decitabine, work in~     different ways to stop the growth of cancer cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Giving MDM2 inhibitor AMG-232~     together and decitabine together may work better in treating patients with acute myeloid~     leukemia.~   "
40113|NCT03041675|"~     Ileus occurs from hypomotility of the gastrointestinal tract. Causes of Paralytic ileus~     include post-operation, stroke, and bed-ridden for a long time. Medicine treatment is less~     and less effective over time. Some study revealed that Moxibustion and Acupuncture are~     effective in Paralytic ileus. Investigators try to find other treatment except of medicine.~     Laser Acupuncture is a safe and non-invasive choice. This study is to evaluate effect of~     Laser Acupuncture on Paralytic ileus.~   "
40114|NCT03041662|"~     This observational study of a national cohort of 600 Swedish PSC patients include yearly~     MR/MRCP, biobanking of serum, plasma and blood, followup clinical data (interventions,~     symptoms, labs, colonoscopy). The aim is to collect a well characterized cohort of PSC~     patients and provide future possibilities to evaluate biomarkers for prognosis and early~     cancer detection.~   "
40115|NCT03041649|"~     The objective of this study is to compare two low profile balloon gastrostomy button enteral~     feeding devices, both currently used as standard of medical care. The investigators aim to~     compare family preference and rate of complications between the two devices in a prospective~     cohort of children. This is the first step in comparing initial and long-term outcomes along~     with the need for seeking medical advice for gastrostomy site-related complications.~      The secondary aim of this study is to follow this population long term (4 years) to document~     the prevalence of: granulation tissue, infection, skin breakdown, and how long the~     gastrostomy tube balloon remains functional (does not lose water).~   "
40116|NCT03041636|"~     The goal of this clinical research study is to learn if Jakafi (ruxolitinib) can delay, lower~     the amount of therapy you may need in the future, or possibly eliminate the need for future~     therapy in recently diagnosed chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma~     (SLL) patients.~      This is an investigational study. Ruxolitinib is FDA approved and commercially available for~     the treatment of myelofibrosis (MF). It is considered investigational to use ruxolitinib to~     treat CLL/SLL. The study doctor can explain how the study drug is designed to work.~      Up to 40 participants will take part in this study. All will be enrolled at MD Anderson.~   "
40117|NCT03041623|"~     An objective of JIPS Registry is to examine disease behavior of idiopathic interstitial~     pneumonias (IIPs), considering classification, background, and diagnostic methods based on~     American Thoracic Society (ATS)/ European Respiratory Society(ERS) /Japanese Respiratory~     Society (JRS)/ Latin American Thoracic Association (ALAT) guidelines for diagnosis and the~     ATS/ERS classification of 2002 and 2013.~   "
40144|NCT03041259|"~     A Phase I/IIa Dose-Escalation Study Evaluating the Safety, Tolerability and Efficacy of~     Rejuveinix in Combination With Standard Interventional Therapy for Critical Limb Ischemia~     Patients with Rutherford Class 4, 5 and 6 Disease~   "
40123|NCT03041545|"~     Physical activity during chemotherapy has been shown to increase patient health and wellbeing~     as well as improve outcomes in breast cancer patients. The primary aim of this project is to~     determine the feasibility of incorporating wearable sensors into clinical care by having~     breast cancer patients, undergoing chemotherapy, wear a commercially available monitor~     (Fitbit) that tracks physical activity, sleep, and heart rate monitor.~   "
40124|NCT03041532|"~     Colorectal cancer (CRC) is the most common tumor and the second leading cause of death in the~     Western world. The decrease in incidence and mortality by CRC in the population undergoing~     screening has been observed. Colonoscopy is the recommended method for detecting tumors in~     early stages, as well as identifying and resecting adenomatous polyps, which are the~     precursor lesions of most CRCs. Colonoscopy should be of high quality to decrease incidence~     and mortality by CRC and avoid interval cancer. The literature shows that colonoscopy does~     not prevent right colon lesions in the same way as the left colon lesions, with most of the~     interval cancers located in the right colon. Studies published so far show an increase in the~     adenomas detection rate (ADT) in the right colon in a second visualization of this segment~     and an increase between 2 and 10% if this second examination is performed with the proximal~     retroflexion maneuver .Retroflexion is a safe maneuver in expert endoscopists. The aim of our~     study is to evaluate the ADT in right colon by means of a second visualization by performing~     proximal retroflexion or second frontal visualization at random in the CCR screening~     population.~   "
40125|NCT03041519|"~     This study is intended to compare the feasibility, safety and efficacy of a zero-fluoroscopy~     approach using Ensite NavX as the only imaging modality with conventional fluoroscopic~     approach for the catheter ablation of idiopathic ventricular arrhythmias; conventional~     fluoroscopic approach use fluoroscopy plus Ensite NavX or plus Carto as the imaging modality.~   "
40126|NCT03041506|"~     Shoulder dislocation is the most common joint dislocation presented to the emergency room~     (ER) and reduction by medical team is always needed. Shoulder dislocation and reduction are~     often very painful and require some form of sedation, pain relief and muscle relaxation for~     reduction maneuvers. Several sedation protocols for reduction maneuver are described in the~     literature, and each institution is guided by its own protocol to optimize patient comfort~     and safety. At the Tel Aviv Medical Centre (TLVMC) ER sedation with ketamine and midazolam~     are the mainstay form of sedation for shoulder dislocation reduction.~      Sedation is not without risk, it is time consuming for the medical staff, and need personal~     supervision. Sedation under busy ER conditions can cause a burden to the medical team which~     can end up in treatment insufficiency and patient safety failure.~      Ultrasound (US) guided interscalene block (ISCB) for shoulder surgery was found to be an~     effective method for perioperative analgesia. However, there is limited data on performance~     of US guided ISCB for shoulder dislocation reduction and its comparison to other analgesic~     modalities Both techniques (block and sedation) for shoulder dislocation procedure are being~     performed for two years at the TLVMC, however no study was done to evaluate these two~     analgesic modalities.~      The current study compares sedation vs. US guided ISCB for the treatment of shoulder~     dislocation in the ER at the TLVMC.~      Study objective:~      Comparison of two common analgesic methods, Sedation vs. US guided ISCB, for shoulder~     dislocation reduction in our institution.~      Study design:~      This is a prospective, randomized, interventional, open-label study with two arms- Sedation~     group and US guided ISCB group. The sedation will be conducted by the orthopedic surgeon who~     is certified to perform sedation and the US guided ISCB will be conducted by a certified~     anesthesiologist.~      Primary outcome:~      Time frame measured from the beginning of reduction procedure until readiness for dismissal~     from the ER according to the physician decision.~      Secondary outcomes [short list]:~      Visual Analogue Score (VAS), patient satisfaction, complications, US guided ISCB and sedation~     failure rate, overall reduction success rate, readmission rate to the ER, daily activity~     level measured by Quick DASH (Disabilities of Arm, Shoulder and Hand) outcome measure.~   "
40127|NCT03041493|"~     The goal is find out if the use of Electronic cigarettes (EC) leads to the same changes that~     we see in blood vessels of traditional cigarettes (TC) users. The investigators will also~     enroll non-smokers as controls, against which they will measure changes in blood vessels in~     TC and EC users.~   "
40128|NCT03041480|"~     To assess the association between periodontal parameters, serum lipid profile and Lp-PLA2~     level in systemically healthy Chronic Periodontitis subjects and healthy controls.~   "
40129|NCT03041454|"~     The purpose of this project is to identify and use our knowledge on the barriers and~     facilitators to using systematic reviews (SR) by health care managers (HCM) and policy~     markers (PM) to develop and test a novel format for presentation of SR for HCM and PM. We~     will invite HCM and PM from hospitals and regional authorities in Ontario, Alberta, and~     British Columbia to participate in a randomized-control trial. Participants will receive a~     link to an online consent survey, and then be randomly allocated to receive access to a novel~     SR or its traditional presentation. There is no time limit to completing the task, and~     participants are able to save their responses and finish later. Participants are able to~     withdraw from the study by not completing the task.~   "
40130|NCT03041441|"~     The purpose of this study is to estimate the intracranial pressure (ICP, the pressure in your~     head) in subjects with intracranial hypotension (a condition caused by leakage of the fluid~     that surrounds your brain and spine) using non-invasive magnetic resonance imaging (MRI)~     techniques, and to determine whether changes in estimated ICP are seen after treatment of~     this condition.~   "
40131|NCT03041428|"~     Mechanical ventilation, in spite of being a life-saving technique, can also induce lung~     injury (VILI) mediated by an inflammatory response, thus having a profound impact in the~     course of critically ill patients. Ventilatory strategies aimed to minimize this VILI have~     reduced mortality rates. Patients suffering cardiogenic pulmonary edema may need venoarterial~     extracorporeal oxygenation, at the same time they are being mechanically ventilated. The~     objective of this study is to analyze changes induced by the use of utraprotective~     ventilatory strategies in the inflammatory lung response of these patients and their impact~     on outcomes.~   "
40132|NCT03041415|"~     While low-income midlife and older adults are disproportionately affected by chronic diseases~     that can be alleviated by regular physical activity, few physical activity programs have been~     developed specifically with their needs in mind. Those programs that are available typically~     do not address the recognized local environmental factors that can impact physical activity.~     This research aims to evaluate the added effects on two-year physical activity levels of a~     novel citizen science neighborhood engagement program (called Our Voice) when combined with~     an evidence-based, individually-focused physical activity program (Active Living Every Day),~     relative to the individually-focused program alone. The programs will be delivered in~     affordable housing settings, and represent a potentially scalable means for promoting~     physical activity across broader income groups in the US.~   "
40156|NCT03041103|"~     Acceptability and tolerance of a new food product in adults and children.~   "
41851|NCT03018912|"~     Sleep disorders are commonly under-recognized in the primary care setting and available~     screening tools are often are limited. The study inestigators hypothesize that the use of a~     novel subjective sleep vital sign (VS) will improve recognition of patients with sleep~     disorders and can be utilized to track outcomes to sleep therapy.~   "
40133|NCT03041402|"~     Non invasive ventilation (NIV) is generally delivered by pneumatically triggered and~     cycled-off Pressure Support (PSP) through a facial mask. Compared to PSP, Neurally Adjusted~     Ventilatory Assist (NAVA), which is the only ventilatory mode using a non-pneumatic signal,~     i.e., diaphragm electrical activity (EAdi), to trigger and drive ventilator assistance,~     improves patient-ventilator interaction. A specific setting to generate neurally controlled~     Pressure Support (PSN) was recently proposed for delivering NIV by helmet. The investigators~     here compare PSN with PSP and NAVA during NIV by facial mask, with respect to arterial blood~     gases (ABGs), patient comfort, and patient-ventilator interaction and synchrony.~      Three 30-minute trials of NIV were randomly delivered to 14 patients immediately after~     extubation to prevent post-extubation respiratory failure: 1) PSP, with an inspiratory~     support ≥8 cmH2O; 2) NAVA, adjusting the NAVA level to achieve a comparable peak EAdi~     (EAdipeak) as during PSP; 3) PSN, setting the NAVA level at 15 cmH2O/mcV with an upper airway~     pressure (Paw) limit such to obtain the same overall Paw applied during PSP. We assessed~     EAdipeak, ABGs, peak inspiratory flow (PIF), time to reach PIF (PIFtime), pressure-time~     product of the first 300 (PTP300-index) and 500 (PTP500-index) milliseconds after initiation~     of patient effort, patient comfort, inspiratory trigger delay (DelayTR-insp), and the rate of~     asynchrony, as assessed by the Asynchrony Index (AI%).~   "
40134|NCT03041389|"~     The therapeutic options are limited in Parkinson's Disease (PD) patients with insomnia and~     are often based on pharmacological treatments. It has been shown that the cognitive~     behavioral therapy can be effective in primary insomnia. To the investigators knowledge, the~     effect of computerized cognitive behavioural therapy on insomnia in PD has not been evaluated~     before. The aim of this study is to demonstrate the beneficial effects of 6-weeks of~     computerized cognitive behavioural therapy on clinical and sleep variables of insomnia in~     Parkinson's disease patients.~   "
40135|NCT03041376|"~     A multicenter randomized controlled trial, with follow-up at 6 and 12 months. Physically~     inactive participants with chronic heart failure with preserved or mid-range ejection~     fraction will be randomly assigned to intervention or control arms.~      The six-month intervention will consist of an individualized pedometer-based walking program~     with weekly step goals, monthly face-to-face sessions with the physician, and monthly~     telephone calls with the research nurse. The intervention will be based on effective~     behavioral principles (goal setting, self-monitoring, personalized feedback).~      The primary outcome is the change in 6-minute walk distance at 6 months. Secondary outcomes~     include changes in serum biomarkers levels, pulmonary congestion assessed by ultrasound,~     average daily step count measured by accelerometry, anthropometric measures, symptoms of~     depression, health-related quality of life, self-efficacy, and MAGGIC Risk Score.~   "
40136|NCT03041363|"~     To determine the maximum tolerated dose (MTD), as a percentage of calories consumed, of~     triheptanoin (C7 oil; C7) in a pediatric and adult patient population genetically diagnosed~     with glucose transporter type 1 deficiency disorder (G1D).~   "
40137|NCT03041350|"~     Direct medical control using video conferencing capabilities of smartphones has never been~     conducted in out-of-hospital cardiac arrest patients. This study was conducted to investigate~     its feasibility and treatment effectiveness in out-of-hospital cardiac arrest (OHCA) patients~     using a real-time smartphone video call.~   "
40138|NCT03041337|"~     The aim of this registry will be to compare the pathophysiological response of the morphology~     and function of the right heart and pulmonary circulation assessed with resting and~     stress-echocardiography in patients with various cardiovascular diseases, to compare them to~     healthy individuals. The physiological response in healthy individuals as well as elite~     athletes, defined as athletes participating at national and international competitions, will~     also be evaluated. Patients will be enrolled both prospectively as well as retrospectively~     and the will be evaluated by resting and stress echocardiography, which are part of the~     routine clinical practice.~      All clinical outcome measures will be collected as part of routine examinations. The~     measurements will include systolic and diastolic pump function of the right and left~     ventricles and other echocardiographic parameters. Moreover, a comparison of these parameters~     among different groups will be performed. Other optional assessments will include: exercise~     capacity assessed with 6-minute walking distance, World Health Organization functional class~     (WHO functional class), peak oxygen uptake assessed by spiroergometry. Patients will be~     evaluated at baseline and each year with the aforementioned procedures according to the sites~     clinical routine.~   "
40139|NCT03041324|"~     The purpose of the study is to evaluate the safety, tolerability and effect on leukocyte and~     plasma Iduronate 2-Sulfatase (IDS) enzyme activity of ascending doses of SB-913. SB-913 is an~     intravenously delivered Zinc Finger Nuclease (ZFN) Therapeutic for genome editing. It inserts~     a correct copy of the IDS gene into the Albumin locus in hepatocytes with the goal of~     lifelong therapeutic production of the IDS enzyme.~   "
40140|NCT03041311|"~     This is a study to investigate the potential clinical benefit of trilaciclib (G1T28) in~     preserving the bone marrow and the immune system, and enhancing antitumor efficacy when~     administered with carboplatin, etoposide, and atezolizumab (E/P/A) therapy in first line~     treatment for patients with newly diagnosed extensive-stage SCLC.~      The study is a randomized, double-blinded, placebo-controlled design. The study will include~     3 study phases: Screening Phase,Treatment Phase (induction part + maintenance part), and~     Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study~     treatment and completes at the Post-Treatment Visit. Approximately, 100 patients will be~     enrolled in the study.~   "
40141|NCT03041298|"~     Guerbet conducted a non-interventional post-marketing surveillance study on its Magnetic~     Resonance Imaging (MRI) contrast agent Dotarem (gadoteric acid/gadoterate meglumine) from~     September 2011 to December 2013. The aim of this study, which was conducted in accordance~     with section 67, paragraph 6 of the German drug regulation, Arzneimittelgesetz, was to~     generate additional data on the diagnostic efficacy, reliability and safety of Dotarem in~     Magnetic Resonance (MR) mammography.~   "
40142|NCT03041285|"~     The aim of the study is to determine the toxicity of Idronoxil (NOX66) when used in~     combination with palliative radiotherapy for metastatic prostate cancer~   "
40143|NCT03041272|"~     The purpose of this study is to identify the incidence rate and characteristics of aggressive~     behavior perpetrated by patients and visitors in inpatient medical units and to understand~     the role of missed care events, professional quality of life and self-efficacy in~     relationship to aggressive events.~   "
40145|NCT03041246|"~     Pregnancy and vaginal delivery are considered as the main risk factors for damage to the~     pelvic floor. There are various ways to measure the strength of the pelvic floor and to~     evaluate functional problems. Manual mobilization of the pelvic floor is a well-known~     treatment modality, however, ample knowledge exists on the efficacy of physiotherapy and~     exercise for improvement of pelvic floor function and strength. The aim of this study is to~     analyze the influence of pelvic floor fascial mobilization (PFFM) technique on the function~     and strength of the pelvic floor muscles as well as parameters presumed to be influenced by~     the strength of the pelvic floor in pregnant women.~   "
40146|NCT03041233|"~     The purpose of this registry is to assess the performance and clinical effectiveness of a~     combination of SJM mapping and ablation products in the treatment of subjects with atrial~     fibrillation (AF).~   "
40147|NCT03041220|"~     Retrospective chart review using both out patient and inpatient records of obese patients~     (BMI of 30 or greater) who have had a cesarean section since the year 2009. We will evaluate~     the patient's BMI, their skin incision type at time of c-section, their co-morbidities,~     number of previous c-sections and post partum follow up for wound infection, wound separation~     and wound breakdown. We will also review operative notes to evaluate blood loss, length of~     surgery and complications during surgery. We will obtain maternal characteristics and~     information about the pregnancy.~   "
40148|NCT03041207|"~     This is a prospective study with three specific aims: (1) To convene a consensus conference~     to develop a guideline for antibiotic use in infants (age < 3 yrs) with suspected~     ventilator-associated infection; (2) To evaluate outcomes before and after implementation of~     the antibiotic guideline; (3) To evaluate changes in the tracheal microbiome over the course~     of mechanical ventilation~   "
40149|NCT03041194|"~     This is a pilot study on subjects who suffer from Interstitial Cystitis (IC) to assess the~     dietary affects on urine pH in relation to their symptoms. The goal of this pilot study is to~     determine which foods/beverages affect urinary pH and exacerbate patient's symptoms.~   "
40150|NCT03041181|"~     This is a randomized phase II study assessing the activity of single agent chemotherapy~     combined with nivolumab (Arm A) compared to single agent chemotherapy alone (Arm B) in~     squamous or non-squamous NSCLC subjects with primary resistance to prior PD-1 or PDL-1~     inhibitor. The single agent chemotherapy chosen is at the discretion of the site investigator~     and may include pemetrexed, gemcitabine or taxotere. Institutional standards should be used~     for administration of the single agent chemotherapy. For both treatment arms, 21 days equals~     1 cycle of therapy and subjects will be eligible to continue treatment until progressive~     disease by RECIST v1.1 or unacceptable toxicity.~      Upon registration, subjects will be randomized in a 1:1 ratio to either treatment with single~     agent chemotherapy or single agent chemotherapy in combination with nivolumab. Randomization~     is un-blinded and open-label; therefore there will be no placebo treatment for subjects~     randomized to single agent chemotherapy~   "
40151|NCT03041168|"~     The proposed study is evaluating a novel technology, Carotid Stenotic Scan (CSS), developed~     by the sponsor, CVR Global. Study Design. This is a prospective cohort study that will~     compare a new application of a technology, the CSS device, to reference standards for~     assessment of carotid disease.~   "
40152|NCT03041155|"~     The research protocol is a Randomized Clinical Trial that has the effectiveness of a given~     respiratory muscle training protocol over the indicative variables: Pulmonary function;~     Markers of oxidative stress and inflammation, endothelial markers and Quality of life in~     patients with chronic kidney disease undergoing hemodialysis. According to the Investigators,~     this topic was proposed since it is known that several pulmonary complications occur as a~     consequence of chronic kidney disease due to uremic myopathy. Therefore, the hypothesis is~     that the application of a respiratory muscle training protocol will contribute positively~     pulmonary functionality and a decrease in oxidative stress and inflammation in chronic kidney~     patients, consequently, will bring improvement in the quality of life for these patients. The~     Patients will be divided into two groups: control group - No intervention of the Muscular~     Training (CG) And Intervention Group (GI). The intervention protocol will be composed of~     respiratory muscle training And lasts for two (2) months, with three (3) visits per week. It~     will be carried out through Threshold PeP appliance. The twelve (12) first training sessions~     will have a total duration of 30 minutes 15 minutes with inspiratory load of 20 cmH2O and 15~     minutes with expiratory load of 20 CmH 2 O; and the others (12) twelve sessions will last 40~     minutes each, with 20 minutes with an inspiratory load of 20 CmH2O and 20 minutes with~     expiratory load of 20 cmH2O. The variables evaluated will be: muscular strength Respiratory~     (maximum inspiratory pressure and maximum expiratory pressure - Pimáx and Pemáx); Lung~     function (Slow Vital Capacity - CVL, forced expiratory volume in the first minute - VEF1,~     Vital Capacity Forced - CVF and Maximum Voluntary Ventilation - VVM); Serum levels of~     oxidative stress markers, endothelial markers and endothelin.~   "
40153|NCT03041142|"~     Obesity has been considered as one of the primary factors for the development of pathologies~     and cardiovascular risk factors. In the child it has been mediator for the development of~     these comorbidities still in childhood, in the adolescence and more strongly in the adult~     age, at the time of most cardiovascular events with death records. Objective: To analyze the~     effects of an interdisciplinary intervention program on the cardiovascular risk factors of~     overweight and obese children. Methods: It was conducted a physical activity program,~     nutritional and psychological orientations, lasting ten weeks with overweighed children and~     their mothers. Thirty-three children with BMI considered overweight and obese participated in~     the study, they were divided into two groups, experimental (n=14) and control (n=19).~     Physical activities occurred 3 times a week with children and once a week with mothers.~     Nutritional and psychological counseling occurred once a week with both children and mothers.~     BMI, waist circumference, waist-height ratio, percentage of fat, cardiorespiratory fitness,~     systolic and diastolic blood pressure, lipid profile, glucose, left ventricular mass, daily~     energy intake and parental perception of children's weight were analyzed. For the statistical~     analysis it was first verified the normality of the data by the Shappiro Wilk test, with the~     variables that presented normality the possible differences were verified through the Anova~     test of mixed design with the post hoc of Bonferroni, for the normal variables, but that~     presented significant difference in the initial moment of the research, it was resorted to~     the Ancova, finally, for the non-normal variables the U tests of Mann Whitney and Wilcoxon.~   "
40154|NCT03041129|"~     The Investigators will measure if hepatic glucose metabolism is upregulated towards de novo~     lipogenesis (DNL) via multiple intrahepatic pathways in obese girls with PCOS and hepatic~     steatosis (HS), compared to PCOS without HS and obese controls without HS. HS will be~     correlated to relative post-prandial hyperglycemia. Post-prandial hyperglycemia will be worse~     or remain unchanged in youth treated with oral contraceptives and better with metformin.~   "
40155|NCT03041116|"~     This study will investigate whether fosmetpantotenate (RE-024), a phosphopantothenate~     replacement therapy, is safe and effective in treating patients with Pantothenate~     Kinase-Associated Neurodegeneration (PKAN).~   "
40157|NCT03041090|"~     PET (Positron Emission Tomography) images are used to help make patient management decisions~     in staging and treatment assessment, often after a cancer diagnosis.~      Improper injections of PET tracers (dye) may occur approximately 15% of the time. This is~     known as extravasation or infiltration, and it compromises the doctor's ability to read the~     PET image. Often, the site where the tracer is injected into the vein (usually in the inside~     of the elbow) are not in the images taken, so reading physicians are unaware that an~     extravasation or infiltration has occurred.~      Technology exists to capture time activity curves (amount of tracer in a location over a~     period of time) during the PET tracer uptake period (usually once the tracer is injected, the~     tracer circulates for 60 minutes prior to images), which can enable physicians to accurately~     detect extravasations and infiltration. This information is currently unavailable to~     physicians reading routine PET/CT (computed tomography) scans.~      Time activity curves information gathered from these sensors during the circulation period~     appear to match the brief pictures taken approximately 70 minutes after the tracer injection.~      This study will determine if these time activity curves correspond to PET images of the~     injection site taken during the tracer uptake period. If time activity curves correspond to~     PET images, they can be used to determine if the tracer was properly injected. If there was~     an improper injection, clinicians can be alerted to this fact and interpret the image with~     this additional information.~   "
40158|NCT03041077|"~     Joint discomfort is reported by 32% of U.S. adults, and increases with age. The knee is the~     most common site of joint discomfort regardless of age. Nearly half of people with knee joint~     discomfort use natural supplements to alleviate symptoms, but more research is needed to~     determine their effectiveness. In a previous study, we measured the effect of 8-weeks~     ingestion of a commercialized joint support dietary supplement (InstaflexTM Joint Support,~     Direct Digital, Charlotte, NC) compared to placebo on joint discomfort, stiffness, and~     function in adults with self-reported joint discomfort. This study will be repeated using~     Instaflex Advanced, with a longer 12-week time period. The Instaflex Advanced supplement~     includes six products: turmeric, resveratrol, Boswellia serrata, collagen, hyaluronic acid,~     and black pepper extract. This unique blend may improve joint function and increase mobility,~     but has not yet been tested in humans using a randomized, double-blinded, placebo-controlled~     research design. The primary purpose of this study is to assess the effect of 12-weeks~     ingestion of the Instaflex Advanced supplement compared to placebo in improving knee function~     in adults with self-reported knee joint discomfort.~   "
40159|NCT03041064|"~     This is a randomized, double-blinded, single-center, split body and split face, multiple~     natural sunlight exposure evaluation of two marketed sunscreens under actual use conditions~     in healthy volunteers. Eligible subjects will be randomized to two treatment randomization~     groups: Left SPF (Sun Protection Factor) 100+/Right SPF 50+ or Left SPF 50+/Right SPF 100+.~     Assessment of erythema and pigmentation will be performed at baseline and after all natural~     sunlight exposure periods which will occur on at the same beach location over the course of 5~     consecutive days. Subjects will be suspended from further natural light exposure periods~     following the observation of sunburn at any exposed body site.~   "
40160|NCT03041051|"~     The purpose of this study is to determine the effect of a combined vaccination schedule of~     the 13-valent pneumococcal conjugate (PCV13) and 23valent plain polysaccharide vaccine~     (PPV23) on the establishment of immunological memory in HIV-infected adults on ART.~   "
40161|NCT03041038|"~     The ichthyoses are a group of lifelong genetic disorders which share characteristics of~     generalized skin thickening, scaling and underlying cutaneous inflammation. There are no~     therapies based on growing understanding of what causes the disease. However, there have been~     recent discoveries of marked elevations in expression of interleukin-17A (IL-17A) and~     IL-17-related cytokines in the skin of individuals with ichthyosis, which may explain the~     inflammation. Investigators propose that IL-17-targeting therapeutics will safely suppress~     the inflammation and possibly the other features of ichthyosis, improving quality of life.~   "
40162|NCT03041025|"~     GSK2330811 is a humanized monoclonal antibody which is in development for systemic sclerosis~     (SSc), a rare autoimmune disease with high morbidity and mortality. Currently, there are no~     approved disease modifying therapies and it is an area of high unmet medical need. GSK2330811~     has been shown to bind and neutralize Oncostatin M (OSM) that has been associated with~     fibrosis, vasculopathy and inflammation in a number of diseases. This multi-center,~     randomized, double-blind (sponsor open), placebo controlled, proof of mechanism study will be~     the first study to evaluate the safety, tolerability, pharmacokinetics (PK) and~     pharmacodynamics (PD) of repeat subcutaneous (SC) doses of GSK2330811 in male and female~     participants with diffuse cutaneous SSc (dcSSc). Participants with active disease and a~     disease duration of <= 60 months will be enrolled. Approximately 24 to 40 participants will~     be randomized across two sequential cohorts. Cohort 1 will evaluate a repeat-dose predicted~     to provide sub-maximal inhibition of OSM, leading to a dose escalation decision. Cohort 1 is~     planned to consist of at least 4 participants, randomized such that 3 participants will~     receive GSK2330811 100 milligram (mg) and 1 will receive placebo. Cohort 2 is planned to~     consist of at least 20 participants, randomized such that participants will receive~     GSK2330811 300 mg and placebo in a 3:1 ratio respectively. The duration of the study is up to~     34 weeks including a screening period of up to 6 weeks, treatment period of 12 weeks and~     follow-up period of 16 weeks.~   "
40163|NCT03041012|"~     To evaluate the effect of early viral reactivation by latency reversing agents (LRA) and/or~     administration of potent broadly neutralizing antibodies (bNAb) on the size of the latent~     HIV-1 reservoir in treatment naïve HIV-1 patients initiating antiretroviral therapy (ART)~   "
40164|NCT03040999|"~     The purpose of this study is to determine the efficacy and safety of pembrolizumab given~     concomitantly with chemoradiation (CRT) and as maintenance therapy versus placebo plus CRT in~     participants with locally advanced head and neck squamous cell carcinoma (LA HNSCC). The~     primary hypothesis is that pembrolizumab in combination with CRT is superior to placebo in~     combination with CRT with respect to event-free survival (EFS) per Response Evaluation~     Criteria in Solid Tumors (RECIST) version 1.1 by blinded independent central review (BICR).~   "
40165|NCT03040986|"~     This phase II trial studies how well selumetinib sulfate works in treating patients with~     pancreatic cancer with KRAS G12R mutations that has spread from where it started to nearby~     tissue or lymph nodes or other places in the body. Selumetinib sulfate may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth.~   "
40168|NCT03040947|"~     The purpose of this study is to develop imaging protocols when using cardiovascular magnetic~     resonance (CMR) to assess cardiac functions, morphology and tissue characterization. The~     National Heart Research Institute Singapore (NHRIS) houses two dedicated CMR scanners to~     support the numerous investigator initiated projects in patients with various cardiac~     pathologists. By optimizing novel CMR sequences used in these studies, scanning time can be~     shortened for patients with underlying cardiac diseases.~   "
40169|NCT03040934|"~     This study is a prospective, multi-center, open-label, randomized controlled clinical~     trial,aims to assess the safety and effectiveness of the Firehawk™ sirolimus target-eluting~     coronary stent system with abluminal grooves containing a biodegradable polymer (Firehawk™)~     comparing the XIENCE everolimus-eluting coronary stent system in the treatment of subjects~     with total coronary occlusion lesion(s).~   "
40170|NCT03040921|"~     This prospective nonrandomized multicenter phase I study, will evaluate the feasibility of~     performing uterine transposition before chemoradiation for rectal cancer and uterine~     reimplantation after the treatment.~   "
40171|NCT03040908|"~     The 6-minute walk (6MWT) test is used in adults and children affected by a wide range of~     chronic diseases to evaluate their sub-maximal exercise capacity. It reflects the global~     response of various physiological systems (respiratory, cardio-vascular, neurologic,~     metabolic and musculosquelettic) in a situation simulating a daily life activity. In children~     with sickle cell disease, the 6MWT is correlated with a low level of hemoglobin, a low level~     of fetal hemoglobin and low red cell deformability. Our team previously reported that in a~     population of children with sickle cell disease, highly treated with hydroxyurea, the sole~     factor which was independently linked to the 6MWT was the presence of silence infarct.~      As the cardio-vascular and cerebro-vascular injury in sickle cell disease are directly~     correlated with hemolysis, the investigators aim to evaluate a) the clinical relevance of~     endothelial and inflammation parameters and new hemolysis markers and b) if the presence of~     silent infarct and the 6MWT are correlated with this biological markers.~      This cross-sectional study will include sickle cell disease patients regularly followed for~     more than 5 years at Hôpital Universitaire des Enfants Reine Fabiola, Centre Hospitalier~     Universitaire (CHU)-Brugmann, Centre Hospitalier Etterbeek-Ixelles, CHU Saint-Pierre,~     Cliniques Universitaires Saint-Luc (Bruxelles, Belgium). Inclusion criteria are: sickle cell~     disease (SS, Sbeta°, SC, Sbeta+), age range : 6 to 25 years, signed informed consent.~     Exclusion criteria are: transplanted patients, inability to perform the 6MWT (severe~     cognitive disability, femoral osteonecrosis with functional impairment), hospitalization and/~     or transfusion in the last 3 months for acute event.~      Demographic data and clinical data will be retrospectively recorded. Blood test and 6MWT will~     be performed in steady state. Studied analysis will be: coagulation factors, free hemoglobin,~     Pro-B type natriuretic peptide (Pro-BNP), High sensitivity C reactive protein (HS-CRP),~     Intercellular Adhesion Molecule (ICAM), Vascular Cell Adhesion Molecule (VCAM) and Selectins.~      With this study, the investigators expect to validate new predictive markers for~     cardio-vascular or cerebrovascular injury and to identify patients at high risk to develop~     these complications.~   "
40172|NCT03040895|"~     This study evaluate if a parental guidance programme based on the International Child~     Development Programme (ICDP) offered to the general Norwegian population, has an effect on~     caregivers, the relationship between caregiver and child, and on children's Development.~   "
40173|NCT03040882|"~     The post-operative treatment of pediatric patients operated for the correction of flat foot,~     sees today the use of preformed leg-foot splint (Walker) as an alternative to the application~     of plaster casts. The change of the immobilization system has led to the appearance of~     problems of tolerability in particular in the skin. The problems persist also after placing a~     polyurethane foam dress at the heel in the immediate postoperative period. The aim of this~     study is to evaluate the effectiveness of a cotton sock applied inside the leg-foot splint in~     children operated vs the Elastic Compression Wraps in reducing the incidence of cutaneous~     lesions.~   "
40174|NCT03040869|"~     Coronary heart disease (CHD) is the leading global cause of human death. Over the past~     decade, level of overall diagnosis and treatment of CHD has been greatly improved due to the~     progression of clinical research and development of technical means and the mortality of CHD~     has decreased by nearly 50% in western countries [1]. However, there are surveys shows that~     with the improvement of living standards and changes in lifestyle, the incidence of CHD is~     still rising in China and other developing countries, and the prevalence trend is obvious~     younger [2]. The so-called young CHD, generally refers to the age at onset of CHD is less~     than or equal to 45 years. Compared with other age-group CHD, young CHD has the following~     characteristics: 1. Genetic factors have a stronger effect at younger onset ages, and~     incidence with obvious familial aggregation[3]; 2 Often with the onset of acute coronary~     syndrome, presumably may be associated with strong inflammation of the lesion; 3. Two~     extremes often exists in coronary lesions: mild or no atherosclerosis and severe~     triple-vessel disease; 4 Rapid progression of atherosclerotic lesions, stent restenosis in~     the same site repeated after interventional treatment, rapid progress of lesion in~     non-intervention site;5 Surgical mortality is low in regardless of interventional therapy or~     bypass surgery, but the rate of revascularization is significantly higher in following 10~     years.~   "
40175|NCT03040856|"~     Omega-3 fatty acids are good fats, and are among the most important nutrients lacking in~     Western diets today. The average person in developing countries consumes less than 100 mg of~     DHA daily. With increasing awareness of the importance of DHA, many people realize that they~     need to make a change in their diet by adding DHA-rich foods or supplements.~      The aim of this study is to learn the effect of different supplementations from the omega 3~     group on the maternal and fetal fatty acid profile during pregnancy and to study their~     epigenetic influence.~   "
40176|NCT03040843|"~     Altered mental status (AMS) is common in older patients. However there is a lack of~     standardization in the definition and documentation of this compliant. Different perception~     of AMS can cause negative impact on interpretation and obtaining scientific data. Although~     definition of AMS is so complicated, clinical documentation can be detected in these patients~     with AMS.~   "
40177|NCT03040830|"~     The study aims to know whether starting progesterone luteal support in intra cytoplasmic~     sperm injection (ICSI) cycles on the day of ovum pickup affects the degree of difficulty of~     embryo transfer compared with starting luteal support on day of embryo transfer~   "
40178|NCT03040817|"~     Diabetic gastroparesis, postsurgical gastroparesis, idiopathic gastroparesis and primary~     pyloric stenosis are debilitating gastrointestinal motility disorder. However, there is~     limited medical therapeutic options for these diseases. Gastric peroral endoscopic~     pyloromyotomy (G-POEM) is an emerging novel endoscopic technique which is reported as a~     minimally invasive therapy. But so far, the efficacy and safety of G-POEM on these diseases~     are rarely explored. So, there is a cooperative group composed of five clinical centers for~     clinical research in G-POEM.~   "
40180|NCT03040791|"~     Prostate Cancer (PC) is the most frequent cancer in men, accounting for 21% of new cases of~     cancer in men in the United States. Among the four most incident tumors (breast, lung and~     colorectal cancer); prostate cancer is the only that does not have any predictive biomarker~     to guide the treatment. Even though the molecular heterogeneity of PC is well-documented,~     treatment has not been molecularly stratified and the need for genetic prognostic and~     predictive markers is critical.~      DNA repair defects (DRD), mainly in the Homologous Recombination (HR) pathway (such as BRCA1,~     BRCA2, ATM and CHEK2) are emerging as potential biomarkers in prostate cancer. It is well~     known BRCA1 and BRCA2 carriers have better Progression-Free Survival (PFS) and Overall~     Survival (OS) than non-carriers in ovarian cancer. Differently than ovarian tumors that BRCA~     mutations provides a good prognosis, PC patients who harbor HR defects have a higher Gleason~     score 6, an increased risk of recurrence and poor prognosis. The predictive role of DRD in PC~     was demonstrated in a recent trial using Olaparib, a PARP inhibitor, in DRD carriers. This~     trial showed 88% of response rate with Olaparib, a PARP inhibitor that acts in HR pathway by~     synthetic lethality.~      Recent data demonstrated important association between HR deficient high-grade serous ovarian~     cancer (HGSOC), high neoantigen load and high expression of PD-1/PD-L1 compared with HR~     proficient HGSOCs 10. This study showed that BRCA1 and BRCA2 mutations increase the number of~     tumor-infiltrating lymphocytes (TILs) and confer a better prognosis. The unprecedented~     success of immunotherapy in malignant disorders has provided evidence that the patient's~     immune system can be improved to attack established tumors, mainly melanoma, non-small cell~     lung cancer and kidney cancer. A high mutational burden increases the likelihood of the~     development of specific neoepitopes that would confer clinical benefit from CTLA-4 and PD-1~     blockade.~      These data showed that specific DNA repair defects increase the mutational burden, the~     expression of PD-1/PD-L1 and TILs; and could improve the response to immunotherapy in cancer.~     This rationale was already tested in a trial that evaluated the PD-1 checkpoint inhibitor~     Pembrolizumab in mismatch-repair deficient patients, a kind of DNA repair defect by~     definition. This important trial showed that this DRD predicted clinical benefit of immune~     checkpoint blockade in many types of cancer, especially colorectal cancer.~   "
40181|NCT03040778|"~     The overall purpose of this project is to answer the following clinical question: Among~     Medication-Related Osteonecrosis of the Jaw (MRONJ) patients, do those who are treated with~     the Pentoxifylline and Tocopherol (PENTO) regimen and standard of care, when compared to~     those treated with standard of care alone, have decreased areas of exposed bone after one~     year of treatment?~   "
40182|NCT03040765|"~     This study is to compare the two medications Denosumab and Zoledronic Acid For Patients With~     Beta Thalassemia Major Induced Osteoporosis. Patients with B-thalassemia major induce~     osteoporosis will undergo baseline assessment of the bone densitometry by Dual-energy X-ray~     absorptiometry scan as a standard of care by the radiology department, then a blood test for~     bone specific Alkaline phosphatase and type-1 Carboxy Telopeptide will be measured by the~     chemistry lab.~      Patients with B-Thalassemia Major induced osteoporosis, who are 18 years of age or more and~     willing to participate in the study will be enrolled after consenting by the primary~     investigator in hematology outpatient clinic. Patients with osteoporosis will receive one of~     the two medications, at the end of the year Dual-energy X-ray absorptiometry scan will be~     done to compare the response of the two medications. The potential risks include the~     drug-related side effects~   "
40183|NCT03040752|"~     A randomized controlled double blinded study included 200 women with preterm contractions.~     After successful arrest of contractions women were randomized into 2 equal groups: GI women~     received nifedipine 20 mg tablets twice daily and GII women received Ritodrine 5 mg tablets~     every 6 hours. The primary outcome was gestational age at delivery and the secondary outcomes~     include episodes of recurrent preterm labor, mode of delivery, maternal side effects and~     neonatal outcome~   "
40184|NCT03040739|"~     Acetabulum fracture are high energy trauma in young people as it can be the result of a~     simple fall in elder people. This fracture generates an incongruity between acetabulum and~     femoral head. So surgery is recognized as the best treatment even if technically difficult~     because of the the complexity of anatomy.Navigation is widely used in orthopaedic surgery .~      The aim of the study is to evaluate the effect of peroperative navigation system on reduction~     of the acetabulum articular surface~   "
40185|NCT03040726|"~     The goal of this clinical research study is to learn if netupitant/palonosetron can help to~     decrease chronic nausea and vomiting in patients with cancer. The safety of the study drug~     will also be studied.~      Some participants will receive the study drug and some will receive a placebo. A placebo is~     not a drug. It looks like the study drug but is not designed to treat any disease or illness.~     It is designed to be compared with a study drug to learn if the study drug has any real~     effect.~      This is an investigational study. Netupitant/palonosetron is FDA approved and commercially~     available to help prevent short-term nausea and vomiting. Giving it to patients with chronic~     nausea and vomiting is investigational.~      The study doctor can explain how the study drug is designed to work.~      Up to 42 participants will be enrolled in this study. All will take part at MD Anderson.~   "
40186|NCT03040713|"~     This study is designed to assess the usefulness of 18F-AV-1451 in Positron Emission~     Tomography imaging for subjects diagnosed with Frontotemporal Dementia.~   "
40187|NCT03040700|"~     The FAMOUS Trial is a single-center, prospective, randomized study aimed to compare three~     different strategies (clinical, anatomical, or functional) in preventing MACE after CABG. A~     total of 600 patients will be included and followed for 5 years. Patients will be randomly~     allocated (1:1:1) in one of the three follow-up strategies. Patients in the clinical arm will~     be followed by regular medical visits only every 6 months; patients in the functional arm~     will undergo a myocardial perfusion scan, and those in the anatomical arm will be subjected~     to a coronary CT. Non-invasive tests will be performed per protocol and regardless symptoms~     every 2 years after the first year post-surgery. The primary outcome will be the incidence of~     death, acute myocardial infarction or myocardial revascularization.~   "
40188|NCT03040687|"~     Enterotoxigenic Escherichia coli (ETEC) is a major cause of diarrhea worldwide. Vaccines and~     therapeutics are under development to prevent ETEC disease in children and travelers. One~     approach is to use passive protection (antibodies) to prevent infection. The purpose of this~     study are to assess the safety of serum-derived bovine immunoglobulins in healthy adult~     subjects when orally administered and to estimate protective efficacy of those preparations~     against moderate-severe diarrhea upon challenge with the ETEC strain B7A.~   "
40206|NCT03040453|"~     Local ablative treatment of Hepatocellular Carcinoma is performed primary on patients not~     eligible for liver transplant or liver resection. At our Hospital two different methods are~     used: Microwave ablation, where the tumor cells are heated up and killed, and Irreversible~     electroporation, where the tumor cells are exposed to an electrical field and nano-pores are~     formed in the cell membranes and the cells go into apoptosis (programed cell death).~      Previous studies have shown effects on the immune system after ablative therapies.~      The purpose of this study is to compare the immunological response after the wo different~     methods of killing the tumor cells.~   "
40189|NCT03040674|"~     The purpose of the Lung Institute is to collect and isolate a patient's own cells and~     platelet rich plasma (PRP) and deliver the product back to the patient same-day. Lung~     Institute's treatment is limited to self- funded patients with chronic lung disease - chronic~     obstructive pulmonary disease (COPD) and interstitial lung disease (ILD). The patient's cells~     and platelet rich plasma are collected through venous or bone marrow harvesting techniques.~      The hypothesized outcomes of Lung Institute therapy are safety and minimization of adverse~     events, a perceived improvement in the patient's lung condition (to be determined by their~     ability to be more physically active; walking greater distances with or without oxygen and~     improved quality of life scales), an improvement in the FEV1 among COPD patients, the ability~     to reduce their use of oxygen and possibly to stop it., the ability to function well without~     the use of rescue inhalers, reduction or ceasing of secondary pulmonary infections, reduction~     in emergency room visits and exacerbations related to their disease.~   "
40190|NCT03040661|"~     Patients who undergo ablation for AF typically have 2 sheaths placed in each groin, including~     a large sheath when the Cryo Balloon is used for pulmonary vein isolation. During the~     procedure, heparin is administered to maintain a target ACT > 300 seconds. At the conclusion~     of the procedure, the venous sheaths are removed and hemostasis is obtained. There are at~     least 2 ways of obtaining hemostasis after venous access. In the manual hemostasis approach,~     an ACT is checked and protamine is administered. The ACT is rechecked 20 later, and if < 220~     msec, the sheaths are pulled and hemostasis is achieved with manual pressure (Manual~     Hemostasis Group). Another approach is to place a Figure of 8 suture around the sheaths in~     each groin to achieve hemostasis as the sheaths are removed, and therefore obviate the need~     for assessment of the ACT, protamine administration, and manual pressure (Figure of 8 Group).~   "
40191|NCT03040648|"~     Transforaminal epidural block (TFEB) with local anesthetics and steroid is effective to treat~     spinal radicular pain. However, inadvertent intravascular injection can lead to severe~     neurologic complications. Digital subtraction angiography (DSA) during epidural block might~     increase the detection rate of intravascular penetration, compared to real-time fluoroscopy~     (RTF). But, DSA has disadvantages, such as additional radiation exposure to physicians and~     participants and the high cost of the new and upgraded fluoroscopic equipment. In this study,~     it was designed to compare DSA and RTF for detection of intravascular penetration in the same~     participant who underwent cervical TFEB.~      The investigators prospectively examined the participants who received cervical TFEB. The~     needle position was confirmed using biplanar fluoroscopy and 2 ml of nonionic contrast media~     was injected at the rate of 0.5 ml/sec under RTF. Thirty seconds later, 2 ml of nonionic~     contrast media was injected at the rate of 0.5 ml/sec under DSA.~   "
40192|NCT03040635|"~     This is a randomized, placebo-controlled study to investigate the safety, tolerability,~     pharmacokinetics and pharmacodynamics of single oral doses of RO7034067 in healthy Japanese~     participants.~   "
40193|NCT03040622|"~     This study will evaluate thrombogenicity in patients undergoing left atrial appendage closure~     using the WATCHMAN device. Parameters of thrombosis and platelet function, as well as other~     bio-markers, will be measure before, during, and after WATCHMAN implantation at several~     follow up visits.~   "
40194|NCT03040609|"~     The main objective of this study is to develop and validate a visio-behavioral scale of~     visual abilities for subjects with profound multiple intellectual disabilities.~      The secondary objectives of the study are:~        -  to validate the structure of the scale.~        -  to evaluate the reproducibility of scale with the intra- and inter-examiners, and the~          influence of the different professions of examiners.~        -  to evaluate the feasibility of visio-behavioral scale.~        -  to evaluate the sensitivity to change.~        -  to study the uniformity of use of the scale depending on the type of patients (age,~          disability level, pathology).~        -  to study the prevalence of the visual disorder in profound multiple intellectual~          disabilities subjects.~   "
40195|NCT03040596|"~     Voice disorders are the most common communication disorder across the lifespan and vocal fold~     nodules are the most frequent pathology affecting voice in children. The goal of the present~     study is to determine the safety and feasibility of a short-course of inhaled corticosteroids~     in addition to standard voice therapy for treating vocal fold nodules.~   "
40196|NCT03040583|"~     The ASSESS national multi-center prospective cohort (Assessment of Systemic complications~     (Signs) and Evolution in Sjögren's Syndrome SS) was set up in 2006 thanks to a grant of the~     French Ministry of Health. Fifteen centers for autoimmune diseases consecutively included~     consecutive patients with Primary Sjögren's Syndrome pSS fulfilling American-European~     Consensus Criteria (AECG) between 2006 and 2009. The study was approved by the Ethics~     Committee of Bichat Hospital in 2006. All patients gave their informed written consent. This~     study was followed for 5 years with the grant of the French Ministry of Health and this study~     will be extended for 20 years by French Society of Rheumatology (SFR). On an annual basis for~     a duration of 20 years, a thorough standardized paper case report form (CRF) was filled~     prospectively by clinicians.~   "
40197|NCT03040570|"~     A feasibility study to determine if it is possible to perform a safe, adequately powered, and~     affordable multi-centre study in critically ill children comparing current practice of~     liberal targets for systemic oxygen levels with more conservative targets.~   "
40205|NCT03040466|"~     Reusable flexible ureteroscopes are widely used to treat various upper urinary tract diseases~     including urinary stones. However, they require a long turnover time between procedures~     because of the sterilization process. Moreover, repeated use of a scope ultimately~     deteriorates its image quality which leads to a high maintenance cost in the long-term. A~     disposable digital flexible ureteroscope was released in the United States in January 2016,~     offering an improved image resolution, new scope performance characteristics with every case,~     and no need for sterilization and repair. Preliminary data from our center has demonstrated~     that disposable scopes shorten operative time by 25% compared to reusable fiberoptic scope~     and are associated with a 2/3 reduction in procedural complication rate. Therefore, treatment~     with disposable scopes may be more effective for patients and facilitate cost management~     within the hospital.~      Here, we propose a three-armed, prospective randomized study, comparing treatment outcomes~     between disposable digital, reusable fiberoptic, and reusable digital flexible ureteroscopes.~   "
40207|NCT03040440|"~     The purpose of this study was to compare the cuff pressure between cylindrical and TaperGuard~     endotracheal tube during laparoscopic cholecystectomy.~   "
40198|NCT03040557|"~     The plantar fasciitis (PF), most frequent injury of the musculoskeletal system, is the main~     cause of heel pain and functional disability. The mechanical stress, stretching of plantar~     fascia consequently the overload on the feet, is a major intrinsic causes the onset of FP,~     especially when exposed to repetitive activities, such as walking. Another extrinsic~     etiologic factor of great influence is inadequate shoes that can lead to a deterioration and~     progression of the disease. One of the great difficulties of their conservative treatment is~     long rehabilitation period, lasting on average 10 to 18 months. Among them, the insoles stand~     out as one of the effective mechanical treatments to improve the immediate pain symptoms, in~     the short term. Other literary evidence, not specific to FP, has shown the benefits, the~     short and long term, a flexible footwear promotes more flexible feet and overload reduction.~     Objective: Verify therapeutic effect in the long term, a flexible footwear and low cost and~     orthopedic insole on the clinical aspect, functional and biomechanics of the gait of women~     with acute FP and chronic with presence of heel spur. It will be conducted a randomized~     controlled trial with blinded evaluator, in which 75 women with plantar fasciitis will be~     randomized and allocated to the intervention group with flexible footwear (GIC, acute n=15~     and chronic=15) or the intervention group with orthopedic insole (GIP, acute n=15 and chronic~     n=15) or control group (CG, n=15). The intervention will have duration six months, six hours~     a day, seven days a week (42 hours/week). For all groups will be allowed to use pain~     medication support (paracetamol 500 mg) with a maximum dose of two grams daily. The primary~     outcome will be the symptom of pain verified by visual analogue scale (VAS), and the~     secondary: the inability to areas of the feet by the total score of the FFI (Foot Function~     Index), health feet by FHSQ-Br questionnaire (Foot Health Questionnaire Status), the distance~     traveled by the six-minute walk test (6MWT), paracetamol consumption and the joint angles of~     the lower limbs, plantar pressure and ground reaction force during gait. The effects of time~     (Start, 3 and 6 months), group (GIC and GIP CG) and interaction (time and group) are~     calculated by means of ANOVA case-wise two factors. A 5% alpha to significant differences and~     Cohen coefficient for describing the size effect of the intervention is assumed.~   "
40199|NCT03040544|"~     Background: Laparoscopic surgical procedures have become increasingly established in~     operative medicine. They require special motor, haptic, and spatial-visual skills to perform~     the interventions safely and effectively. The basic skills are often learned in the operating~     room on the patient. This is economically inefficient and can be improved with regard to~     patient safety. Against the background of this problem, various simulators were developed in~     order to train laparoscopic basic skills outside the surgery. The Lübecker Toolbox (LTB)~     curriculum is a video-based trainer, which - unlike the other trainees on the market - has~     standardized and validated exercises with concrete targets, based on the skills of experts in~     minimally invasive surgery (MIC). Against the background of different, non-validated training~     programs and simulators with ambiguous objectives, it is not known how training programs and~     simulators improve the skills of the advanced physicians in performing laparoscopic-assisted~     operations. An evidence of effectiveness in the practice transfer could have a considerable~     relevance with regard to the integration of the training programs into the specialist~     doctoral training.~      Aim of the study: The aim of the study is to investigate whether physicians in the first~     years of further education are able to improve laparoscopic skills required to perform~     laparoscopic operations, if they have successfully completed the LTB curriculum.~      In the prospective study, the subjects are randomized into two groups, one group completing~     the LTB curriculum after the first own laparoscopic cholecystectomy and the other not. After~     2 months, both groups will perform their first laparoscopic cholecystectomy again. The~     laparoscopic video recordings will be analysed and compared using the Global Operational~     Assessment of Laparoscopic Skill (GOALS) score.~   "
40200|NCT03040531|"~     Prolonged glucocorticoid therapy affects bone fragility, cardiovascular health, glucidic and~     lipidic metabolism, thyroid and brain function. Glucocorticoid-induced osteoporosis is~     characterized by low bone turnover and fractures, which occur in 30-50% of patients.~     Glucocorticoids affect predominantly cancellous or trabecular bone, increasing the risk of~     vertebral fractures, which may be asymptomatic and occur early during the first months of~     glucocorticoid treatment. Genistein exerts biological effects by several potential~     mechanisms. Besides protective effects on bone loss, genistein reduces cardiovascular risk~     markers, improves endothelial function and ameliorates glucose and lipid metabolism. This~     study is aimed at demonstrating genistein efficacy in glucocorticoid-induced osteoporosis in~     a cohort of caucasian post-menopausal women.~   "
40201|NCT03040518|"~     In 2014, 24% of UK men were obese. However men rarely participate in weight loss programmes.~     This study looks at whether two interventions which show promise can help obese men lose~     weight and keep it off.~      INTERVENTION 1: Sending text messages to a mobile phone. These will be written as though they~     come from other men who are also losing weight and include 'how to do it' diet and physical~     activity tips, combined with friendly humour and support.~      INTERVENTION 2: The same texts plus promising men money at the start contingent on weight~     loss achievement. The money will vary over a year according to whether weight targets are~     met. This is called an endowment incentive and is based on research showing that modest~     payment helps people change their diet and physical activity. At the 3, 6 and 12 month~     weighing appointments, men will have the option of continuing with the original weight loss~     targets of 5%, 10% and 10% or setting lower targets of 5% of body weight at 6 months and 5%~     at 12 months. This is to maintain motivation and hope for men who do not meet the more~     ambitious weight loss targets.~      This study examines if the texts work better with incentives than alone. Both interventions~     are delivered from a computer and have potential to reach large numbers, including men who~     don't use health services. This work is done together with obese men and a charity for men to~     help us find the best ways to deliver the interventions to as many men as possible, including~     men in difficult life situations.~      This study will examine whether it is acceptable and feasible to randomise obese men to three~     groups: texts only; texts and incentive; or to a 'control group' who wait a year and then get~     the texts for 3 months. The feasibility of recruiting 105 obese men from two regions of~     Scotland will be assessed. Half of the men will get an invitation letter from their GP. The~     other half will be approached in the community, given information about the study and invited~     to take part. Men can take part if their waist circumference is 40 inches and more or their~     Body Mass Index is 30 or higher. The study examines how long it takes to find 105 obese men~     who want to take part, how many come back to suitable venues at 3, 6 and 12 months to get~     weighed and answer questions about their quality of life, lifestyle and motivation. At the~     end participants will report about their experiences of weight loss and of being in the~     study.~   "
40202|NCT03040505|"~     The aim of the study is to investigate temporal organization of future thinking in patients~     with schizophrenia. Patients and control participants will be asked to envision and briefly~     describe ten personal future events using a cue-words list. Then they will be asked to~     describe everything that came to their minds (i.e. to think aloud) while they attempted to~     determine when an event will likely occur. The investigators will compare the proportion of~     several predefined strategies mentioned by the two groups of participants to locate future~     events in time. The investigators predict that patients will envision less personal future~     events and will rely to a lesser extent on strategies to locate events in time, than control~     participants.~   "
40203|NCT03040492|"~     The purpose of this study is to discover whether certain Vitamin D Receptor (VDR) gene~     polymorphisms are associated with an increased risk of cutaneous basal cell carcinoma (BCC)~     and/or cutaneous squamous cell carcinoma (SCC) in an Alabama population. Participant~     demographic information such as physical characteristics (e.g., ethnicity), family history,~     and cancer diagnosis will be collected in order to determine if there are relationships~     between the gene polymorphisms, cancer diagnosis, and these characteristics.~   "
40204|NCT03040479|"~     This is a multicenter, open-label, non-randomized, parallel-group, single dose study. This~     study will enroll up to 24 participants and will include 2 hepatic impaired participant~     groups and one group of control participants with normal hepatic function.~   "
40208|NCT03040427|"~     The investigators postulate that F-18 florbetapir will show improved detection of cardiac~     amyloidosis over conventional non-invasive imaging techniques, particularly in early disease.~   "
40209|NCT03040414|"~     Adolescents and young adults with type 1 diabetes often have a difficult time achieving good~     glucose control which is so important in reducing the risk for diabetes complications.~     Despite the use of multiple daily injections or insulin pumps and glucose sensors there is~     still a need for many individuals to further improve glucose levels but do so without causing~     low blood glucose levels (hypoglycemia) or adding to the daily burden of living with~     diabetes. Today an insulin pump can receive glucose readings from a continuous glucose~     monitor and adjust the insulin delivery up or down in an attempt to keep glucose levels in a~     more optimal range. These systems are called hybrid closed loop meaning while much of the~     insulin delivery is automated the patient still interacts regularly with the system~     particularly to help determine the insulin dose to deliver to cover a meal. Results of early~     studies using hybrid closed loop systems in adolescents and adults with type 1 diabetes are~     very encouraging. This study will compare the FDA-approved hybrid closed loop system by~     Medtronic (670G) to a next-generation Medtronic system programmed to further improve glucose~     control, particularly around mealtime, which is currently one of the biggest challenges with~     all hybrid closed loop systems. One hundred adolescents and young adults (ages 14-30) will~     test each system for three months in a crossover fashion. The investigators will compare how~     effective each hybrid closed loop system is at preventing high blood glucose readings during~     day. The investigators will also evaluate the safety of each system and how participants~     adjust to the daily use of the technology.~   "
40210|NCT03040401|"~     Enrolled subjects will receive histamine dihydrochloride (HDC; Ceplene®) and/or IL-2~     (Proleukin®) subcutaneously (s.c.) twice daily (BID) in 3-week periods followed by 3- or 6~     week rest periods.~      All subjects will be assigned to one of three consecutive cohorts, each comprising five~     patients.~      Cohort 1 will receive HDC without IL-2 for the first treatment cycle, to enable the~     assessment of short-term impact of HDC alone on clonal and immunological markers. For all~     remaining cycles the combination of HDC and IL-2 will be given.~      Cohort 2 will receive the combination of Ceplene and Proleukin in all cycles. After all~     patients in cohorts 1 and 2 have completed 4 treatment cycles, immunological and clinical~     response and toxicity will be evaluated. On the basis of the results for the first 4 cycles~     of cohorts 1 and 2, a third cohort of 5 patients will be enrolled receiving either the~     combination of HDC/IL-2 or HDC alone.~      In case of a beneficial response* after 4 cycles, treatment may be continued to a total of 10~     cycles. Treatment cycles 5-10 will comprise 3 weeks of treatment and 6-week rest periods.~      IL-2 will be administered s.c., 1 µg/kg (=16400 IU/kg) body weight twice daily (BID) during~     treatment periods. Ceplene® will be administered s.c. 0.5 mg BID after IL-2. The patient or a~     family member/significant other will be instructed to administer injections of both study~     drugs to allow safe treatment at home.~   "
40211|NCT03040388|"~     The main purpose of this study is to determine whether electroconvulsive therapy (ECT) causes~     any structural or functional brain changes and thus indicating its mechanism of action. The~     second aim is to find predictors of an immediate response, sustained remission, relapse and~     side-effects. Thirdly, this study aims to explore whether ECT causes any changes in~     blood-brain barriers permeability and whether these changes correlate to memory problems. The~     fourth objective is to examine whether ECT causes any brain tissue damage.~   "
40212|NCT03040375|"~     Undernutrition and poor cognitive development affect many children under 5 in developing~     countries, who are exposed to multiple risk factors including poverty, malnutrition, poor~     health, and unstimulating home environments. The optimum development and growth of young~     children requires affection and responsiveness from the mother/caregiver, cognitive~     stimulation, good nutrition and infection control. In Bangladesh, stimulation at home is~     generally poor and contributes to children's poorer development. It is important to show that~     psychosocial stimulation programmes through home visits integrated into the feeding~     programmes can benefit children's growth and development. This study will help to fill this~     evidence gap about effective interventions to improve infant and young child growth and~     development in Bangladesh. Considering the high prevalence of undernutrition and low~     prevalence of stimulating environments in Bangladesh, it is important to show evidence that~     integrating infant feeding counselling and psychosocial stimulation activities result in~     optimum child growth & development. To determine if combined infant feeding counselling and~     psychosocial stimulation programme (promoting mothers positive parenting) starting in the 3rd~     trimester of pregnancy, further improves: children's cognitive, motor and language~     development along with growth and mothers' child rearing and child-feeding knowledge and~     practices compared to peer counselling alone or usual health messages only. We used a~     community-based CRCT to examine the impact of a peer counselling infant feeding education~     program with psychosocial stimulation starting in the third trimester of pregnancy to one~     year after delivery, to improve child growth and cognition, language, behaviour and~     psychomotor development compared to a control group receiving usual health messages. The~     outcome assessments were made on a cohort of infant-mother dyads measured at baseline and at~     follow up visits. Outcome assessments were conducted with all the mother-infant pairs~     recruited in the community clusters in the study, with an expected total of 334 mother-infant~     dyads (167 in each treatment group).The main outcomes are children's growth, cognition,~     language, behaviour and psychomotor development~   "
40213|NCT03040362|"~     This study will be an open-label, nonrandomized, absorption, metabolism, and excretion study~     of [14C]-lasmiditan administered as a 200-milligrams (mg) (approximately 100~     microcuries[µCi]) oral solution to 8 healthy males and females, following at least a 10 hour~     fast from food to assess the pharmacokinetics (PK), metabolism, and routes and extent of~     elimination of a single oral dose of 200 mg (approximately 100 µCi) [14C] lasmiditan in~     healthy males and females.~   "
40214|NCT03040349|"~     The overall aim of the TiTAN Greece & Cyprus project is to expand the Global Bridges Tobacco~     Treatment Training Network in the WHO Europe region through a focus on primary health care~     providers in Greece and Cyprus. A robust evaluation will be conducted alongside the TiTAN~     program. A pre-post evaluation will be used to examine the impact on the TiTAN program on:~        1. Provider engagement (number of providers attending training), number of local champions;~        2. Provider knowledge, beliefs, perceived behavioral control, and intentions related to the~          delivery of tobacco treatment;~        3. Rates of evidence-based tobacco treatments (5As) are delivered to patients who smoke;~        4. Provider satisfaction with training program, resources, and network outreach activity~          and areas for improvement; and~        5. Estimates on the impact on patient-level outcomes including number of patient quit~          smoking at 1 and 3-month follow-up.~      All PHC providers will be surveyed before and after the intervention program is delivered. We~     will randomly select a sub-sample of providers and will survey patients from their practice~     before and after the intervention program in order to validate changes in 5As delivery.~     Qualitative interviews will be completed with a sub-sample of providers at the end of year 1.~   "
40311|NCT03039088|"~     This is a prospective observational national (France) study with 2 visits 3 months apart~     (baseline and 12 weeks after TNF alpha blockers initiation). The objective of recruitment is~     500 SpA patients (diagnosis according to their treating rheumatologist) initiating a TNF~     alpha blocker.~      The main objective of the study is to evaluate the impact of a concomitant fibromyalgia on~     the anti-TNF treatment effect in axial Spondyloarthritis in both anti-TNF naïve and~     pre-exposed patients.~   "
40215|NCT03040336|"~     Frail Veterans are at increased risk for poor surgical outcomes, and as the Veteran~     population grows older and more frail, there is a critical need to identify effective~     strategies for reducing surgical risks for these patients. Prior research shows that~     inter-disciplinary rehabilitation strategies deployed after surgery enhance recovery and~     improve outcomes by building strength and improving nutrition. We believe that similar~     improvements may be obtained by using similar interventions before surgery to prehabilitate~     patients' capacity to tolerate the stress of surgery. The proposed research will examine the~     feasibility of a new, prehabilitation intervention aimed at improving postoperative surgical~     outcomes through preoperative exercise training and nutritional supplementation. Findings~     from the study will inform the design of a larger randomized controlled trial of the~     prehabilitation intervention. If proven effective, prehabilitation could benefit as many as~     42,000 frail Veterans who are scheduled for major elective surgery each year.~   "
40216|NCT03040323|"~     The investigators plan to compare complication and success rates between two methods of~     ultrasound guidance for biopsy of liver lesions, contrast-enhanced and the current protocol~     without contrast.~   "
40217|NCT03040310|"~     The prevalence and disability associated with discogenic low back pain are significant, and~     there is a general lack of widely accepted conservative treatments for the condition. A~     majority of previous studies that have assessed the efficacy of self-directed exercise-based~     rehabilitation programs did not include comprehensive metrics to confirm whether participants~     actually participated in the exercises prescribed. In this pilot study, the investigators~     hope to determine whether proxies of compliance with a daily, self-directed rehabilitation~     program for discogenic low back pain are correlated with participant-reported improvements in~     pain and function. The feasibility of a mobile interface designed to help patients with~     chronic low back pain track the daily management of their conditions will also be evaluated.~   "
40218|NCT03040297|"~     The study investigates if there are benefits (better oxygenation, minimized work of breath)~     from the parallel oxygenation with Tracheal Gas Insufflation and T-piece, in order to provide~     respiratory support in tracheostomized patients and avoid mechanical ventilation.~   "
40219|NCT03040284|"~     In patients at risk of increased intracranial pressure (ICP), ICP measurements require~     invasive transducers, usually with insertion of a catheter into the cranium, or through a~     spinal tap. These invasive modalities involve risks and pain and they can be done only in~     specialized care units, with a high associated cost.~      A novel method for detecting changes in ICP has developed recently. The auditory hair cells~     emit sounds and electric signals in response to sound, which can be easily detected and~     measured non-invasively with the help of a microphone probe placed in the external ear canal~     or regular electrodes. Indeed, the cochlear aqueduct connects the cerebrospinal fluid (CSF)~     spaces to the inner ear in such a way that ICP and inner-ear fluid pressure equalize within~     seconds.~      The evaluation of intracranial hypertension by increased ICP (invasive) is not systematically~     used after aneurysmal subarachnoid hemorrhage. It is then detected by using routine clinical~     signs of hydrocephalus or another disorder of cerebrospinal liquid flow, in combination with~     a standard imaging method (TDM).~      The measurement of noninvasive ICP could allow earlier detection of hydrocephalus or another~     disorder of cerebrospinal liquid flow, and evaluate whether the increase in ICP precedes~     patient clinical worsening and / or imaging.~   "
40220|NCT03040271|"~     Evaluate the feasibility and effectiveness of a multi-component school-based intervention to~     promote healthy eating and physical activity with school children ages 9 to 11 years in~     Lebanon.~   "
40221|NCT03040258|"~     Evaluate the feasibility and effectiveness of a multi-component school-based intervention to~     promote healthy eating and physical activity with school children ages 9 to 11 years in~     Lebanon.~   "
40222|NCT03040245|"~     Whiplash trauma and the resulting whiplash associated disorders have been the subject of much~     attention in the scientific literature and remain a major public health problem.~      The most commonly encountered symptoms are neck pain, headache, low back pain, shoulder pain,~     as well as visual impairment. It is not unusual for neck pain to become chronic, and when~     this occurs, there may be serious consequences on a social, professional and financial level.~      Even though the role of the initial episode should not be ignored, progression to chronic~     pain is probably multifactorial and, like non-specific low back pain, psycho-social factors,~     and in particular patient fears and belief, seem to play a relevant role, as do environmental~     factors. The professional consensus is that it is useful to provide targeted information at~     an early stage in whiplash settings in order to reduce mistaken fears and beliefs. A~     preliminary study enabled the investigators to validate a French version of an information~     booklet that draws on validated data from evidence-based medicine. The booklet was Le guide~     du coup de fouet cervical, the French version of The Whiplash Book. This study showed that~     fears and beliefs were considerably high in a population without neck problems who were~     working in hospitals. It also revealed that simply providing information could help lessen~     them.~      Management following whiplash injury can make use of the recommendations as published in the~     literature. Healthcare professionals must reassure and educate their patients that~     post-traumatic pain is normal, and that they need to remain active and maintain physical~     activity in order to improve their prognosis.~      Only very few studies have evaluated the adherence of physicians or healthcare professionals~     to the guidelines and to ways of changing their approach to treatment.~      The main aim of this study was to determine what fears and beliefs physicians have about the~     consequences of whiplash. The secondary aim was to measure the impact of a validated~     information booklet on emergency physicians' approach to management following a whiplash~     injury.~   "
40223|NCT03040232|"~     The purpose of this study is to identify predictors of future injury and disability following~     LPD. The investigators' long term goal is to improve longitudinal outcomes of athletes with~     LPD following surgical and non-surgical management. Currently, there is limited information~     available to clinicians regarding appropriate criteria for returning athletes to sports~     participation following LPD. The evidence produced by this study will provide necessary~     information to develop appropriate rehabilitation strategies that may reduce the risk for~     future patellar instability and associated patellofemoral joint dysfunction and pain.~   "
40224|NCT03040219|"~     Folic acid as a appetizer in primary malnutrition~   "
40225|NCT03040206|"~     This study is to investigate the prognostic significance of enhanced International Prognostic~     Index (NCCN-IPI) and post-treatment PET results in patients with newly diagnosed nodal~     peripheral T-cell lymphoma (PTCL), and establish a risk stratification model for nodal PTCL~     patients.~   "
40312|NCT03039075|"~     Metformin hydrochloride sustained-release tablets made in Conquer pharmaceutical co., LTD is~     approved by China Food And Drug Administration (cFDA). Whether its efficacy and safety are~     equal to Glucophage is unclear.~   "
40313|NCT03039062|"~     This is an open , multicenter, interventional clinical trial to conform the role of of~     miR-122 a real-time detection biomarker of drug-induced liver injury by chemotherapy.~   "
40226|NCT03040193|"~     Flexible bronchoscopy is one of the most widely performed procedures for diagnosis of various~     bronchopulmonary diseases. Most patients tolerate the procedure well although cough is often~     reported as a distressing symptom. It is likely that the acceptance of bronchoscopy would be~     significantly improved with control of cough. Use of sedation during bronchoscopy has been~     reported to improve procedure tolerance. However, awake(no sedation) bronchoscopy is~     routinely performed at many centres including ours.~      Topical lignocaine is administered during bronchoscopy for local anaesthesia. There is~     limited literature on the efficacy of lignocaine delivered with the nebulized route during~     awake flexible bronchoscopy. This study would help to determine the utility of nebulized~     lignocaine in airway anaesthesia during flexible bronchoscopy.~   "
40227|NCT03040180|"~     The purpose of this study is to evaluate the efficacy and safety of neoadjuvant~     electrochemotherapy on locally advanced rectal cancer (UICC II-III) in an intended curative~     clinical setting, using an endoscopic electroporation device (EndoVE).~   "
40228|NCT03040167|"~     The pectoral block is a recently developed regional anesthetic technique that can be used for~     the treatment of postoperative pain after breast surgery. Injection of local anesthetic~     between the major and the minor pectoral muscles is defined as the pectoral (PEC) 1 block.~     This block has not been well characterized in terms of its blocking effects on motor and~     sensitive nerves (medial and lateral pectoral nerves and intercostal nerves). This clinical~     trial is divided into two sections: a volunteer study and a patient study.~      For the volunteer study, the aim is to assess the sensory territory affected by injection of~     local anesthetics through a PEC 1 block and to assess motor function in terms of strength of~     adduction of the affected limb using a dynamometer.~      In a prospective, randomized, controlled and double blind study, the aim is to assess the~     postoperative pain relieving properties of the PEC 1 block in patients undergoing bilateral~     breast augmentation surgery.~   "
40229|NCT03040154|"~     The objective of this community-based randomized controlled trial is to evaluate the outcomes~     of a theory-based parent engagement intervention (i.e., culturally-tailored video) aimed at~     promoting the participation of Filipino parents and grandparents in an evidence-based~     preventive parenting intervention.~   "
40230|NCT03040141|"~     This study is to compare the efficacy and safety of VIS410 in combination with oseltamivir vs~     oseltamivir alone in severely ill subjects with influenza A infection requiring oxygen~     support.~   "
40231|NCT03040128|"~     To date, no neuroprotective drugs have demonstrated clinical efficacy in intracerebral~     hemorrhage (ICH). This study will use intravenous (IV) minocycline in ICH to evaluate for (1)~     safety/ tolerability and (2) evaluate for clinical efficacy~   "
40232|NCT03040115|"~     The aim of this study is to conduct survey-based assessments for the safety of air travel in~     patients with Birt-Hogg-Dube syndrome (BHD). The study will enroll patients through the~     clinic network at Rare Lung Disease Consortium (RLDC) and through the BHD foundation website.~     Patients will have access to the questionnaire via REDCap (an online data management system)~     and each patient will be provided with a link to complete the survey. The investigators plan~     on enrolling approximately 100 patients with BHD for the purpose of this study. Secondary~     aims of this study include further characterization of the clinical aspects of disease and to~     establish a contact registry for these patients, in order to facilitate future studies.~   "
40233|NCT03040102|"~     The purpose of this research study is to compare two ways to educate patients with cancer and~     their caregivers about hospice care services~   "
40234|NCT03040089|"~     This is a prospective, multi-center, split-face, controlled clinical trial that aims to~     investigate the efficacy and safety of picosecond, neodymium-doped yttrium aluminum garnet~     laser laser therapy on patients with melasma, compared with 2% hydroquinone cream. The trial~     will be performed by two Korean institutions on 45 subjects.~   "
40235|NCT03040076|"~     The purpose of this study to test a computerized treatment designed to help people with high~     levels of emotional eating, which is when people eat to cope with negative emotions and/or~     stressful situations. The investigators are interested in comparing two different ways of~     coping with negative emotions, relaxation training or training in how to think differently~     about such situations. Additionally, the researchers' study seeks to understand more about~     the psychological factors that may contribute to someone having difficulty with emotional~     eating.~   "
40236|NCT03040063|"~     Use of endovascular techniques - implantation of a peripheral stent graft and a peripheral~     flexible stent to isolate the sac of the popliteal artery aneurysm from the circulation and~     subsequent topical application of a thrombolytic (rtPA) to restore patency of the lower leg~     blood stream - will lead to a comparable or better outcome in treatment of patients with the~     popliteal artery aneurysm and acute critical limb ischaemia, compared to currently prevailing~     use of surgical treatment.~   "
40237|NCT03040050|"~     The study is a randomized controlled trial. Subjects are randomly assigned 1:1 to receive~     either rapid multiplex qPCR (intervention) prior to standard of care prostate biopsy or~     standard of care (control) prostate biopsy. The subjects will have a rectal culture swab~     performed prior to the prostate biopsy. One rectal culture swab will be used for rapid~     multiplex qPCR and the other swab will be sent to microbiology for a standard culture. The~     subjects randomized to the intervention group will have the qPCR results shared with the~     physician to determine if additional standard of care antibiotics are needed at time of~     standard of care prostate biopsy. The subjects randomized to the control group will not have~     the qPCR results shared with the physician to determine if additional standard of care~     antibiotics are needed at time of standard of care prostate biopsy. Approximately, 10 days~     after the prostate biopsy, the research staff will conduct a chart review and/or telephone~     call to ask about any prostate biopsy infections and complications.~   "
40238|NCT03040037|"~     This is a prospective registry of atrial fibrillation cryoablation in the Russian Federation.~     This study is observational, prospective, multicenter, open-label~   "
40239|NCT03040024|"~     The goal of this prospective randomized double blinded placebo controlled study is to~     investigate if a single dose of ketamine in addition to standard anesthesia will reduce the~     risk of delirium in otolaryngeal cancer patients postoperatively. Ketamine's effect on~     post-operative pain and opioid use will be measured as well. Electroencephalogram (EEG) will~     be utilized during the surgical procedure to evaluate its potential as a possible predictive~     device for delirium.~   "
40240|NCT03040011|"~     To test the hypothesis that preoperative injections along the levator ani muscles and~     pudendal nerve with bupivacaine and dexamethasone improve pain control after vaginal apical~     reconstructive surgery. A three-arm, double-blinded, randomized controlled trial of a total~     of 75 women will be performed.~      The study population will be adult women (>18 years of age) with uterovaginal or vaginal~     vault prolapse who have been scheduled for native tissue vaginal reconstructive surgery which~     includes an apical support procedure. Participants will be enrolled prior to surgery. The~     procedure will involved four injection sites: the bilateral levator ani muscles via a~     transobturator approach and bilateral pudendal nerves via a transvaginal approach. Random~     assignment will occur to one of three study arms: combined arm (20 milliliters~     bupivacaine/dexamethasone solution divided between the 4 injection sites), bupivacaine arm~     (20 milliliters bupivacaine divided between the 4 injection sites), or placebo arm (20~     milliliters saline divided between the 4 injection sites).~   "
40241|NCT03039998|"~     The main objective of project is to compare validity of sampling methods performed routinely~     (bronchial secretion, stomach content, oropharyngeal smear) for determination of etiological~     agent responsible for hospital-acquired pneumonia (HAP) in critically ill patients to~     bronchoscopy-assisted protected brush method. Evaluation of the present clinical praxis using~     bronchial secretion sampling in HAP diagnostics and detection of the most common etiological~     agents in patients with HAP are other priorities of the project. Aiming to confirm or exclude~     the diagnosis of HAP, determine the sources and possible routes of bacterial pathogens~     transmission molecular biology analysis of etiological agents is performed. Finally,~     percentage of HAP etiological agents resistant to initial empiric antibiotic therapy will be~     observed.~   "
40242|NCT03039985|"~     The aim of the study is to evaluate the complication rate of 2 types of all-ceramic crowns in~     patients with or without bruxism.~   "
40243|NCT03039972|"~     Cross-sectional evaluation of hydration status and kidney function in patients with pulmonary~     hypertension~   "
40244|NCT03039959|"~     Evaluation of renal function in patients with pulmonary hypertension undergoing right heart~     catheterization~   "
40245|NCT03039946|"~     The aim of this study is to compare hemodynamic variables and outcome in patients undergoing~     laparoscopic and/or robotic elective abdominal surgery. Patients will receive either an~     automated closed-loop goal-directed fluid therapy (GDFT) guided by non-invasive flow~     monitoring or a restrictive fluid therapy of 4ml/kg/h.~   "
40246|NCT03039933|"~     The overall objective and Primary Aim of this Limited Competition: Small Grant Program (R03)~     is to address the critical need of identifying and decreasing fear of hypoglycemia, which~     will be accomplished by conducting a pilot randomized clinical trial to evaluate the efficacy~     of Blood Glucose Awareness Training, which has been adapted for, but never evaluated in~     adolescents with Type 1 Diabetes (T1D) and their parents.~   "
40247|NCT03039920|"~     Electronic cigarette is proposed as a bridge to smoking cessation. In this study we examine~     its effects on aortic elasticity, glycocalyx integrity, and exhaled carbon monoxide (CO)~     concentration, both acutely and after 1 month of use.~   "
40248|NCT03039907|"~     The main purpose of this study is to examine the factors that allow patients that undergo~     total knee arthroplasty to return to recreational sports and/or work activities, and to~     achieve recommended physical activity levels.~   "
40249|NCT03039894|"~     School engagement is associated with children's long-term health and success. Students who~     are engaged in school have better academic outcomes and lower rates of risky health~     behaviors. The investigators partnered with Alliance College-Ready Middle Academy 12~     (Alliance 12), a charter school in Los Angeles, to develop the gradebook game, an~     intervention that aims to improve academic achievement, peer support, and school engagement.~     The game involves frequent feedback on students' school performance, team-based competition~     aligned with the school mission, and peer mentorship by team captains. For the 2016-2017~     academic year, the investigators will assist Alliance 12 in implementing the gradebook game~     in two of its five 6th grade homerooms. The investigators plan to evaluate whether the game,~     as hypothesized, is effective in increasing school engagement, including academic performance~     and positive behavior.~      In order to conduct this evaluation, the investigators plan to enroll 6th grade students by~     obtaining parental consent and student assent at the beginning of the school year. Students~     will be enrolled for the entire 2016-2017 academic year. All study procedures except for~     parental recruitment will occur during the school day. Participation in the study involves~     completing 2 student surveys and permitting the collection and analysis of student data from~     the online gradebook and behavior system. The investigators plan to use an interrupted time~     series design that will analyze student gradebook and behavior data at multiple time points~     before and after the game starts. The surveys will be completed at the beginning and end of~     the study period. Surveys will include measures of self-reported school engagement, age,~     gender, race/ethnicity, primary language at home, social and emotional well-being, social~     status, and peer support. Surveys will be administered via iPad.~      If the pilot study demonstrates that the gradebook game is effective in promoting school~     engagement and academic achievement, it is anticipated that it could be widely adopted and~     more rigorously evaluated in a larger study. Because the gradebook game is a low-resource~     intervention, it could easily and sustainably be replicated, providing a much-needed tool for~     schools with low engagement.~   "
40250|NCT03039881|"~     This observational study investigates the validity and utility of a new, non-significant~     risk, FDA approved respiratory monitor, ExSpiron, in the perioperative course of patients~     undergoing elective surgery under general anesthesia. The study patients will be monitored~     before, during and after surgery, in post-anaesthesia care unit (PACU) and recovery room for~     the first post-operative night. The physiologic data will not be used or influence the~     standard of care for subjects. It is anticipated that this monitor may be able to improve~     perioperative care in the future.~   "
40251|NCT03039868|"~     SLC6A14 may serve as a biomarker for cervical dysplasia or cervical cancer.~   "
40252|NCT03039855|"~     To evaluate the safety and performance of the Neovasc Tiara Mitral Transcatheter Heart Valve~     with the Tiara Transapical Delivery System.~   "
40268|NCT03039647|"~     Premature and accelerated brain aging trajectories have been observed among people with~     metabolic dysfunction, but mechanisms of these altered trajectories are not understood.~     Insulin resistance (IR) is known to change with age and affect cognition in older and elderly~     adults as well as in patients with mood disorders. The main purpose of the study is to~     describe the developmental trajectory of cognitive and neural biomarkers across the spectrum~     of metabolic dysfunction in overweight/obese adults younger than 50 years of age. The~     innovative study design will allow the investigators to examine cognitive outcome development~     over a 25-year span without an investment into the longitudinal observation of changes in~     cognition and neural function.~   "
40269|NCT03039634|"~     This study evaluates the safety, effectiveness, and maintenance of effect of a novel topical~     silver particle solution (Sienna 755.1100, 810.1100, or 1064.1100) used in conjunction with a~     laser for the treatment of Acne Vulgaris.~   "
40253|NCT03039842|"~     This is a research clinical trial of double-blind, stratified randomized, parallel group,~     two-centre study. It will be conducted in a total of 250~300 male and female subjects from~     the Department of Psychiatry at National Cheng Kung University Hospital. Eligible subjects~     will be psychiatric out- and in-patients, aged between 18~65 years old, who have psychiatric~     evaluation with clinically suspected of having bipolar II disorder and fulfill the inclusion~     and exclusion criteria. The add-on double-blind study treatment with dextromethorphan/place~     will commence at randomization for while patients continue open-label valproate. Subjects~     will be enrolled for 12 weeks double-blind add-on treatment and randomly assigned to (1) 30mg~     dextromethorphan+valproate, (2) 5mg memantine+valproate, (3)~     dextromethorphan+memantine+valproate or (4) placebo+valproate. Concomitant benzodiazepine~     medication (preferably up to 8mg lorazepam) may be used for daytime sedation, agitation or~     insomnia during the study. For the consideration of the less influence to immune-system,~     resperidone 1-3mg/daily and fluoxetine maximum 20mg/daily will be chose. We will measure the~     treatment response and side effect to clarify the curative effect of DM and memantine add-on~     therapy to valproate in the treatment of bipolar disorders. This study is being performed to~     investigate the possibly significant beneficial effects on the subtypes of bipolar disorders~     psychopathology.~   "
40254|NCT03039829|"~     This study will aim to determine whether ingesting creatine nitrate (CrN) at higher doses~     will differentially affect hemodynamic variables compared to a placebo.~   "
40255|NCT03039816|"~     Background: A nasally applied cellulose powder is increasingly used in many countries as a~     remedy for allergic rhinitis. In 2009, a 4-week study in birch pollen-allergic children~     showed a reduction in nasal symptoms. The best effect occurred on days with lower pollen~     counts. The present study in grass pollen-allergic adults used the same basic design.~     Methods: In May 2013, a double-blind, placebo-controlled study was conducted in 108 patients~     with allergic rhinitis due to grass pollen (18-40 years of age). SMS on mobile phones were~     used as reminders of treatment and reporting of symptom scores.~   "
40256|NCT03039803|"~     In recent decades, the rate of cesarean section delivery has steadily increased worldwide~     ranging at 30% of deliveries, thus long-term risks after cesarean section need to be~     evaluated. Postoperative risks include, among others, uterine scar rupture and placental~     complications such as placenta previa and accreta- complications, which are possibly~     associated with uterine scar dehiscence.~      The prevalence of lower-segment uterine scar deficiency has previously been described as 63%.~     One recent systematic review and meta analysis investigated closure techniques of low~     transverse cesarean. No significant difference in risk of uterine scar defect comparing~     single layer versus double layer closure could be detected (RR 0.53), whereas in women with~     single layer closure, a lower residual myo-metrial thickness was observed (-2.6mm). However,~     the authors do conclude that data is insufficient to determine the risk of uterine rupture,~     dehiscence or gynecological outcomes due to insufficient power of available studies. A~     recently published Randomized Controlled Trial concluded that double-layer closure with~     unlocked first layer showed a better scar healing than locked single layer.~      The investigators main objective is to identify if single-layer suture of the uterus during~     cesarean section results in a higher rate of cesarean scar deficiency than double-layer~     suture.~      Interventions~      Single- layer versus double- layer uterine closure Two different techniques of uterine~     closure in cesarean section will be compared: single- layer versus double- layer continuous~     uterotomy suture.~      Standardized transvaginal sonography~      Transvaginal ultrasound examination is carried out by one expert sonographer. The ultrasound~     machine used for all examinations is GE Voluson E10.~      Primary outcome: CS scar deficiency visualized in transvaginal ultrasound at 3 months after~     CS (yes/no).~      Secondary outcome: Myometrial thickness at the site of uterine scar (mm).~   "
40257|NCT03039790|"~     The purpose of this study is to evaluate descriptively the long-term immunogenicity of at~     least 1 Norovirus GI.1/GII.4 bivalent VLP vaccine (NoV) vaccine administration.~   "
40258|NCT03039777|"~     Hemodialysis patients frequently develop catheter-related blood stream bacteremia (CRBSI).~     Procalcitonin is a marker of sepsis in bacterial infection. this study for detection of its~     role as a surrogacy marker in CRBSI.~   "
40259|NCT03039764|"~     To evaluate the effects of virtual reality-based rehabilitation (Neofect Glove) for newly~     diagnosed cognitively intact adult dominant hemisphere stroke patients with paresis of their~     hand in supplementation with conventional occupational therapy to assess whether it improves~     motor function and speed recovery during inpatient rehabilitation versus conventional~     occupational therapy alone. Also, what impact does this have on quality of life.~   "
40260|NCT03039751|"~     The purpose of the study is to evaluate the safety and efficacy of catheter mediated~     endocardial adenovirus-mediated vascular endothelial growth factor-D (AdVEGF-D) regenerative~     gene transfer in patients with refractory angina to whom revascularisation cannot be~     performed.~   "
40261|NCT03039738|"~     The purpose of the study is to evaluate the impact of surveillance monitoring versus~     telemetry monitoring on clinical, healthcare economics, resource utilization, and qualitative~     outcomes.~   "
40262|NCT03039725|"~     Retrospective study to assess a single Clinic on Immunization Practices (ACIP)~     recommendations for hepatitis A, hepatitis B, influenza, tetanus/diphtheria/pertussis, HPV~     and pneumococcal disease~   "
40263|NCT03039712|"~     The primary purpose of the study is to meet the CMS mandated Coverage with Evidence~     Development requirement in the National Coverage Determination for Leadless Pacemakers as~     they apply to Medtronic Micra devices. The study uses administrative claims data of the~     Medicare population implanted with single-chamber ventricular pacemakers~   "
40264|NCT03039699|"~     The purpose of this study is to obtain additional data on efficacy and safety of Ergoferon in~     the treatment of viral intestinal infections in inpatient children~   "
40265|NCT03039686|"~     This is a multi-center, randomized, double-blind, placebo-controlled study to assess the~     efficacy, safety and tolerability of two different weekly doses of BMS-986089 in ambulatory~     boys with Duchenne Muscular Dystrophy (DMD).~   "
40266|NCT03039673|"~     MIROCALS is a phase II study of ld-IL-2 as a therapeutic agent for ALS. A randomized (1:1),~     placebo-controlled, double-blind, parallel group trial will be carried out to assess ld-IL-2~     safety and clinical efficacy on survival and functional decline in newly diagnosed ALS~     patients treated for 18 months. Randomization will be stratified according to (i) country (n~     = 2 levels: UK, France) and (ii) site of onset (n= 2 levels: bulbar vs limb onset).~      The primary objective to evaluate the clinical efficacy and safety of the experimental drug~     (ld IL-2) over an 18 months period in order to establish the proof of concept (PoC) that~     modifying immune responses through the enhancement of regulatory T cells modifies the rate of~     ALS disease progression.~   "
40267|NCT03039660|"~     This study aims to investigate the feasibility and efficacy of online student wellness~     courses for improving medical student mental health and well-being.~   "
40271|NCT03039608|"~     The method of esophageal endoscopic submucosal dissection (ESD) to remove superficial~     esophageal neoplasms has gained widespread acceptance as an alternative to surgery recently~     these years especially in Asian countries. However, besides of perforation and bleeding,~     another complication postoperative esophageal stricture is frequently observed after the~     removal of large-sized esophageal neoplasms by ESD. Dysphagia caused by postoperative~     stricture substantially decreases the patient's quality of life, requiring further therapy.~     Although the exact incidence is unknown, esophageal stricture is supposed to be related to~     the extent of the circumference being resected. In previous study by Ono et al，it is reported~     that 90% of patients with lesions of circumferential extension of more than three-fourths~     experienced postoperative stricture after esophageal ESD. There were some reported studies~     exploring new ways to prevent esophageal stricture after ESD, such as oral prednisolone and~     local corticosteroid injection. Corticosteroids can inhibit not only collagen synthesis but~     also enhance collagen breakdown, thereby inhibiting stricture formation. Some studies reveled~     that just oral prednisolone oral is effective option for the prevention of post-ESD~     stricture. However, most of the reported studies were non RCTs with small sample. In the~     primary study, the investigators search a new method of combination of both oral and local~     injection to prevent esophageal stricture，as a result，stricture at 8 weeks after ESD was~     found in 19 of 36 patients in the no corticosteroid group but only 4 of 34 in the~     corticosteroid group. Unfortunately，the study was also retrospective. So, the investigators~     plan to undertake a prospective, randomized controlled trial to evaluate the prophylactic~     effects of combination of local steroid injection with oral steroid administration for~     esophageal stenoses complicating extensive ESD.~   "
40272|NCT03039595|"~     Early rectal cancer can be removed by minimally-invasive surgery, and the standard~     pathological assessment of the removed tumour gives valuable information about how advanced~     the tumour is. This gives an indication of how likely the cancer is to recur, so doctors and~     patient can decide on the most appropriate further treatment and follow-up. However there is~     still much uncertainty in these predictions about recurrence. This study will assess two~     further pathology tests, ploidy and stroma ratio in the tumour, by correlating the results~     with outcome. This will determine whether these two tests provide additional value in~     predicting outcome. If so, clinicians would be better able to advise patients with early~     rectal cancer about their prognosis and further management.~   "
40273|NCT03039582|"~     Anovaginal distance measured by palpation and perineal ultrasound are similar.~   "
40274|NCT03039569|"~     In this proposed project the investigators will (1) examine the impact of diabetes~     self-management education using text messaging on increasing awareness of CVD risk~     perception, dietary intake, physical activity, diabetes self-management, and quality of life~     among adults with type 2 diabetes; and (2) determine whether diabetes self-management~     education using text messages improve HA1C among adults with Type 2 diabetes. The study~     sample will include 100 adult type 2 diabetes patients (30 years or older). The recruited~     adult type 2 diabetes patients will be randomly assigned into the intervention group (50~     participants) and control group (50 participants). The intervention group will receive 3~     messages weekly consisting of nutrition education and diabetes self-management information~     and skills for 3 months (12 weeks). The messages will consist of information on how to~     increase fruits and vegetables and reduce high-fat and sugary foods intake, increase the~     availability of fruits and vegetables and reduce high-fat and sugary foods in the home,~     strategies to increase diabetes self-management skills, and awareness of cardiovascular~     disease risk perception and knowledge. The text messages will be derived from the American~     Association of Diabetes Educator (AADE) handouts (Reducing Risks, Monitoring, Healthy~     Coping, Problem Solving, Taking Medication, Healthy Eating, and Exercise) Text~     messages will be positive and motivating and will include a link to a specific AADE7 handout~     that allows participants to open and retrieve the specific AADE7 handout. The control group~     will not receive text messages. The participants (both intervention and control group) will~     complete surveys at baseline (before study begins) and at the conclusion of the study (at~     three month of the intervention) about their dietary and lifestyle habits, diabetes self-care~     management, awareness of cardiovascular diseases, home food environment and quality of life.~     We will also collect patient's self-report Hemoglobin A1C values at baseline and at the~     conclusion of the study (at three month of the intervention). If test effective, the proposed~     text messaging intervention will help type 2 diabetes patients to manage diabetes and have a~     healthier lifestyle.~   "
40275|NCT03039556|"~     This study investigates the effects of two weeks of reduced daily ambulation and a subsequent~     return to normal physical activity on metabolic health of older adults.~   "
40276|NCT03039543|"~     Transurethral resection of the bladder tumor (TURB) for bladder tumor excision is the~     mainstream treatment. However, the beneficial effects of sugammadex after general anesthesia~     for TURB have not been thoroughly evaluated. Investigators hypothesized that deep NMB and the~     use of sugammadex as a reversal agent may be associated with better endoscopic surgical~     condition and recovery profile compared with moderate NMB during TURB.~      This study was designed to compare patients with deep neuromuscular blockade (NMB) with~     moderate NMB during transurethral resection of the bladder tumor (TURB) in terms of surgical~     condition and postoperative recovery.~   "
40277|NCT03039530|"~     Postpartum depression (PPD) affects over 14,000 women in Ontario each year and can have~     profound effects on mothers, their children, and their families. The cost of one case of PPD~     exceeds $150,000, a significant proportion of which is related to its impact on offspring.~     However, difficulties accessing preferred treatments (e.g., psychotherapy) result in fewer~     than 15% of women receiving care. While Public Health Units have played an important role in~     PPD detection in Ontario, Public Health Nurses (PHNs) currently lack the skills to deliver~     evidence-based treatment to women. Cognitive Behavioural Therapy (CBT) delivered in group~     format is effective for treating depression in the perinatal period, and as PHNs are often~     the first point of contact for women experiencing PPD, with specialized training it is likely~     that they can deliver high-quality CBT.~      The primary objective of this study is to determine if PHNs can be trained to deliver group~     Cognitive Behavioral Therapy (CBT) to acutely treat PPD, reduce relapse and recurrence,~     improve mother-infant attachment and parenting and optimize infant emotional functioning.~   "
40278|NCT03039517|"~     This is a two arm, prospective, single center, randomized clinical trial. Subjects will be~     randomly assigned into one of two groups using block randomization technique in a 1:1 ratio.~     The control group will receive care using elastic compression stocking and the intervention~     group will use the ACTitouch device. Stratified randomization will occur based on whether the~     Deep Vein Thrombosis (DVT) has iliac or non-iliac involvement. Subjects will be followed for~     2 years with clinic visits occurring at 1, 3, 6, 12, and 24 months.~   "
40279|NCT03039504|"~     This is a randomized, double blind, placebo-controlled, comparative, prospective study~     (clinical evaluation) of the effectiveness and safety of dietary supplement Potensa in men~     with mild to moderate erectile dysfunction.~   "
40314|NCT03039049|"~     Purpose:The aim of this project is to prospectively determine whether a single dose of~     GnRH-agonist administered at the time of implantation increases or not the reproductive~     outcome in patients undergoing in vitro fertilization ( IVF)/ intracytoplasmatic sperm~     injection(ICSI) triggered by a GnRH-agonist followed by a small bolus of human chorionic~     gonadotropin (hCG 1500 IU) the day of oocyte retrieval.~   "
40328|NCT03038867|"~     The investigators are conducting a placebo-controlled, randomized control trial with~     duloxetine in healthy, fertile men not previously on any antidepressants. Participants will~     be randomized to either the duloxetine or placebo groups for 6 weeks. The investigators will~     assess changes in sperm DNA fragmentation at 0, 2, 6, 8, and 10 weeks. Other outcomes~     measured will include semen parameters (sperm concentration, motility, morphology), hormone~     levels (testosterone, estrogen, prolactin, LH, FSH), and sexual function (IIEF and MSHQ)~     surveys.~   "
40280|NCT03039491|"~     The investigators hypothesized that pneumococcal vaccination with either the 23-valent~     pneumococcal polysaccharide vaccine PPV-23 (Pneumovax-23) alone or the 13-valent pneumococcal~     conjugate vaccine PCV-13 (Prevnar-13) followed by PPV-23 results in a similar antibody~     levels/functional antibody activity and induce similar pneumococcal polysaccharide~     (PPS)-specific B cell response in HIV positive individuals > 50 years of age, HIV positive~     individuals 21-40 years of age as compared to HIV negative > 50 years of age. The~     investigators immunized the study groups HIV+ persons >50, HIV+ persons 21-40 and controls~     (HIV negative) with PCV 13 followed by PPV23 and HIV>50 with PPV alone and examined immune~     responses to polysaccharide (PPS) 23 (F),14, 3, 7 (F) and 19 (A) using polysaccharide~     specific ELISA and opsonophagocytic assays (OPA). Pre- and post-immunization peripheral blood~     samples were obtained. Extensive B cell phenotype analysis using fluorescent antibodies was~     used to characterize PPS-labeled B cells. Specific phenotypes were correlated with antibody~     levels and OPA and compared to populations immunized with PPV~   "
40281|NCT03039478|"~     Xylitol and erythritol have become increasingly popular as sugar substitutes in the food~     industry. Both substances are freely available. While glucose ingestion stimulates satiation~     hormone secretion in the gut and slows down gastric emptying, artificial sweeteners such as~     aspartame, sucralose and acesulfame-K have no such effect. However, acute intake of 50g~     xylitol or 75g erythritol in 300mL tap water leads to a marked increase in the satiation~     hormones and induces a significant retardation in gastric emptying. The concentrations used~     to Show this effect were rather high (50g xylitol and 75g erythritol) and led to bloating and~     diarrhea in 60-70% of all subjects two hours after administration. The aim of the present~     study is to find an effective concentration of xylitol and erythritol still stimulating~     satiation hormone release without any gastrointestinal adverse events.~   "
40282|NCT03039465|"~     This study is being conducted at Healthcare Global Enterprises Ltd to evaluate the role of a~     novel Tracheo-Esophageal voice Prosthesis for total laryngectomy +/- partial pharyngectomy~     patients. 30 patients will be enrolled as an inpatient or outpatient.~      Patients who are planned to undergo total laryngectomy +/- pharyngectomy surgery and~     trachea-esophageal puncture procedure.(for primary TEP insertion) or patients who have~     undergone total laryngectomy > 6weeks prior and are suitable candidates for secondary TEP~     insertion would be recruited to the study. Insertion of the TEP will be done in primary~     setting or secondary setting. Patients, who are undergoing primary TEP insertion, will be~     evaluated for speech/ voice at an interval of 6 weeks, 12 weeks and 6 months after the~     procedure. Patients who are undergoing secondary TEP insertion to be evaluated on the same~     day of the procedure along with evaluation at an interval of 6 weeks, 12 weeks and 6 months.~     All the patients will be evaluated clinically for a fluid leak (through and around the TEP)~     on the same days of voice analysis by giving test feeds under supervision.~   "
40283|NCT03039452|"~     Purpose: The purpose of this study will be to examine the feasibility and acceptability of a~     6-week high intensity interval training (HIIT) program in patients with knee OA symptoms~     ranging from mild to severe. A secondary purpose will be to evaluated changes in whole body~     metabolism induced by 6-weeks of HIIT.~      Participants: Fifteen patients (age 40-70 yrs; BMI 20-35 kg/m²) with symptomatic knee OA~      Procedures (methods): All participants will be assigned to the single-arm of the study in~     which all participants will receive 6 weeks of HIIT, delivered twice per week. Outcomes will~     be assessed at baseline and 6 weeks. The primary outcome will evaluate tolerability,~     feasibility, acceptability, compliance, and adherence to the HIIT program. Secondary outcomes~     will include whole body metabolism markers, inflammation, and a set of physical function~     including knee osteoarthritis symptomatic burden and pain, cardiorespiratory fitness,~     isometric knee extensor and flexor strength (factors associated with physical function and~     symptomatic knee OA progression), and body composition.~   "
40284|NCT03039439|"~     This is a pilot biomarker study designed to compare frequencies of mutations between groups~     of malignant, benign and normal tissue or blood of patients with parathyroid disease and~     identify the potential genes showing molecular aberrations as other types of cancer.~   "
40285|NCT03039426|"~     This randomized controlled trial, compared postoperative pain score in patient undergoing~     cesarean delivery between bupivacaine peritoneal and subcutaneous infiltration and diclofenac~     intramuscular injection~   "
40286|NCT03039413|"~     This pilot clinical trial studies how well copper Cu-64 TP3805 positron emission tomography~     (PET)/computed tomography (CT) works in imaging patients with urothelial cancer undergoing~     surgery or biopsy. Radioactive tracers, such as copper Cu-64 TP3805, may bind to tumor cells.~     PET/CT imaging performed with copper Cu-64 TP3805 may be a better way to detect urothelial~     cancer.~   "
40287|NCT03039400|"~     Physical activity is a crucial component to wellness and is associated with multiple health~     benefits. Persons with MS may find it challenging to participate in regular physical activity~     or exercise, which is activity done to improve health and/or fitness. This research will test~     an innovative web-based intervention to help persons with moderate-to-severe disability~     manage their condition through a maintenance exercise program with specialized~     physiotherapist guidance and support. The researchers will examine adherence to the web-based~     physiotherapy program compared to standard physiotherapy care. Forty-five people with MS will~     be randomly assigned to the web group or standard care group at a rate of 2:1. Participants~     in the web group will receive supported and individualized web-based physiotherapy.~     Participants in the standard care group will receive a written exercise program. Regular~     participation (adherence) in the exercise programs will be evaluated in both groups over six~     months. The research will also examine participant satisfaction with the programs, safety, MS~     symptoms, and physical function. A web-based approach may be widely accessible to persons~     with MS in their own homes and could support long-term participation in physical activity~     important to wellness.~   "
40326|NCT03038893|"~     This is a Clinical Trial on the use of Point Of Care Ultrasound for the diagnosis of deep~     venous thrombosis (DVT) and its effect on length of hospital stay. 25 participants with~     suspicion of DVT according to Wells Criteria were randomized to one of two groups: Point of~     Care Ultrasound and Echo Doppler Ultrasound (POCUS + EDUS), and the control group was~     submitted only to the Echo Doppler Ultrasound (EDUS). The primary outcome was hospital stay.~   "
40329|NCT03038854|"~     The purpose of this study is to determine the nutritional and cognitive effects of consuming~     Growing Up Milks (GUMs) and cow's milk.~   "
40288|NCT03039387|"~     Deficient cognitive control (CC) and the use of dysfunctional emotion regulation strategies~     (ERS) are both central characteristics of major depression. Both are associated with reduced~     activity of the dorsolateral prefrontal cortex (dlPFC). Transcranial direct current~     stimulation (tDCS) is a safe, simple and effective non-invasive method to modulate the~     cortical excitability. The goal of this randomized, sham-controlled, double blind clinical~     trial is to examine the effect of transcranial direct current stimulation (tDCS) on the CC~     and ERS in depressed patients compared to healthy subjects. Overall, the study will include~     44 participants (22 depressed Patients and 22 healthy subjects). Each participant will~     complete a CC task while receiving sham tDCS in one session and anodal tDCS in the other~     session (counterbalanced). Afterwards the ERS 'rumination' will be measured during a resting~     phase by means of a questionnaire and psychophysiological measures (heart rate variability).~     The investigators hypothesize (a) an amelioration of CC by anodal tDCS and (b) a reduced use~     of the dysfunctional emotion regulation strategy 'rumination' after anodal tDCS. Overall this~     experiment will provide new and reliable data for the development of new treatment methods.~   "
40289|NCT03039374|"~     There is around 60 000 births annually in Finland. Around 1-5% of all vaginal deliveries in~     Finland complicate in a Grade III- IV perineal tear. Because the diagnosis of a sphincter~     lesion after birth can be challenging the total amount of women having obtained a sphincter~     lesion could be even grater.~      The aim of our study is to compare different tools in the diagnosis of obstetric anal~     sphincter injury. In doing so the investigators hope to achieve early diagnosis of this~     pathology and thus facilitate early treatment of a possible sphincter defect.~   "
40290|NCT03039361|"~     The purpose of this study is to assess the efficacy of Equine Assisted Psychotherapy on PTSD~     symptoms in veterans with PTSD as compared with existing care.~      The investigators' hypothesis is: EAP Participants' will experience decreased PTSD symptoms~     following participation in a 6-week Equine Assisted Psychotherapy program.~   "
40291|NCT03039348|"~     The purpose of this study is to investigate the factors influencing the decision about breast~     reconstruction after breast amputation for breast cancer.~      The study will be conducted at the University Hospital in Brussels using only a~     questionnaire. The results might help us to evaluate and improve the satisfaction among~     patients about the received information and guidance.~   "
40292|NCT03039335|"~     The objective of this study is to prospectively assess whether there is any interval between~     first symptom and initial diagnosis that is experienced by patients with newly diagnosed~     alpha-1 antitrypsin deficiency (AATD) and then to assess whether this diagnostic interval is~     associated with worsened clinical status at the time of initial diagnosis.~   "
40293|NCT03039322|"~     This case-control study was conducted on 90 patients who were equally divided into two~     groups. Group 1 included 45 patients with HCV-related chronic liver disease without clinical~     or radiological evidence of HCC (control group), and Group 2 included 45 patients diagnosed~     to have HCC by Triphasic abdominal CT (patient group). Serum AFP and GP73 were measured using~     ELISA technique~   "
40294|NCT03039309|"~     Multicentre cohort study on the use of endoscopic submucosal dissection for the treatment of~     early gastrointestinal neoplasia.~   "
40295|NCT03039296|"~     In this prospective observational trial the effect of the Endoscopic rhizotomy microinvasive~     therapy should be examined in (approximately 150) adult patients with low back pain positive~     for facet joint pain component.~   "
40296|NCT03039283|"~     The aim of this retrospective study is to collect and assess hearing performance data that~     have been measured by five clinics in Germany as part of their clinical routine in recipients~     implanted with a commercial CI532.~   "
40297|NCT03039270|"~     This randomized, controlled clinical trial, triple-blind, split-mouth type was conducted~     aiming to assess the absolute risk of sensitivity with and without sonic activation of a~     desensitizing gel previously to the in-office bleaching in adults.~   "
40298|NCT03039257|"~     The primary objective of this study is to establish that single dose vitamin A~     supplementation is feasible and safe in pediatric and young adult bone marrow transplant~     recipients until day +30 (± 7 days) after hematopoietic stem cell transplantation.~   "
40299|NCT03039244|"~     The study proposes to assess the effect of multiple applications of antimicrobial~     Photodynamic Therapy (aPDT) as an adjunct to non-surgical periodontal treatment (nsPT) in~     smokers without use of antibiotics. Twenty smokers with a clinical diagnosis of chronic~     periodontitis will be treated in a split-mouth design study to either aPDT associated with~     scaling and root planing (SRP) or SRP only. aPDT will be performed by using a laser light~     source with 690 nm wavelength associated with a phenothiazine photosensitizer. The~     applications will occur in four episodes (at days 0, 2, 7 and 14). All patients will be~     monitored for 90 days. Plaque index, probing depth, clinical attachment level and bleeding on~     probing will be performed at baseline (pre-intervention period) and 30 and 90 days after the~     (nsPT). Subgingival plaque samples will be collected (at baseline and 30 and 90 days after~     the nsPT) and the counts of 40 subgingival species will be determined using DNA-DNA~     checkerboard hybridization. Gingival crevicular fluid samples will be collected (at Day 0,~     14, 30 and 90 after the nsPT) and the levels of Interleukin 1 beta, Interleukin 10 and Tumor~     Necrosis Factor alpha (Luminex) will be evaluated. Salivary cotinine levels will also be~     evaluated at baseline. Data obtained will be statistically analyzed.~   "
40300|NCT03039231|"~     This study will test the efficacy of the Freespira Breathing System in adults with post~     traumatic stress disorder (PTSD).~   "
40301|NCT03039218|"~     This protocol allows for treatment of 100 men in two groups (placebo and active treatment) of~     22-70 years of age with mild (IIEF EF of 17 to 25 at baseline) vasculogenic erectile~     dysfunction of at least 6 months duration with low intensity extracorporeal shock wave~     therapy utilizing the Dornier Aries 2 device.~   "
40327|NCT03038880|"~     This is a Phase II, multicenter, randomized, active comparator-controlled, 52-week study to~     investigate the efficacy, safety and pharmacokinetics of RO6867461 (RG7716) administered with~     extended dosing regimens in treatment-naive participants with nAMD. Only one eye will be~     chosen as the study eye.~   "
41262|NCT03026634|"~     Sleep-disordered breathing is believed to appear at a high prevalence in end-stage heart~     failure patients and the presence of sleep-disordered breathing has been associated with~     increased mortality. This study is designed to investigate prevalence and dynamics of~     sleep-disordered breathing in end-stage heart failure patients pre and post heart~     transplantation.~   "
40302|NCT03039205|"~     About 35% of patients hospitalized with Acute Coronary Syndromes (ACS) have some degree of~     renal dysfunction. Chronic kidney disease (CKD) is not only associated to worse prognosis in~     ACS patients, but leads also to an increased risk of bleeding, which may importantly~     influence the risk-benefit ratio of antiplatelet therapy in this population. The responsible~     mechanisms for increased rate of ischemic events in this population are not completely~     elucidated.~      Antiplatelet therapy is of paramount importance in the treatment of ACS, but its benefit in~     CKD patients is not well established. This population is often excluded or underrepresented~     in large clinical trials, and the indication of antiplatelet therapy is often extrapolated~     from studies in patients with preserved renal function. In recent meta-analysis, Palmer et~     al. sought to evaluate the benefits and risks of antiplatelet agents in patients with CKD and~     concluded that in patients with ACS or scheduled for angioplasty already taking aspirin, the~     addition of clopidogrel or glycoprotein IIb / IIIa inhibitors have little or no impact in~     reducing the incidence of myocardial infarction, death or need for revascularization.~      In the PLATO trial, ticagrelor (a new reversible inhibitor of P2Y12 receptor with faster~     onset of action and greater platelet inhibition) was compared to clopidogrel in patients with~     high risk ACS and was associated to a 16% risk reduction on the occurrence of death from~     vascular causes, myocardial infarction, or stroke. In a pre-specified sub-analysis, data from~     patients with CKD were compared to those obtained from the population with normal renal~     function and suggests that the benefit of ticagrelor may be even greater in patients with~     CKD. Two hypotheses were considered to explain these results:~        1. Greater and more consistent platelet inhibition achieved with ticagrelor would be more~          effective in reducing ischemic events in this population at increased thrombotic risk;~        2. Pleiotropic effects of ticagrelor besides inhibition of the P2Y12 receptor. Ticagrelor~          might be associated with an elevation in serum levels of adenosine. This could improve~          myocardial perfusion through coronary vasodilation, and this effect would be more~          pronounced in patients with renal dysfunction.~      This project aims to validate (or not) these hypotheses, analyzing platelet aggregation and~     circulating adenosine levels in patients taking dual antiplatelet therapy with aspirin and~     clopidogrel or ticagrelor.~   "
40303|NCT03039192|"~     The purpose of the study is to evaluate the efficacy of intranasal esketamine 84 milligram~     (mg) compared with intranasal placebo in addition to comprehensive standard of care in~     reducing the symptoms of Major Depressive Disorder (MDD), including suicidal ideation, in~     participants who are assessed to be at imminent risk for suicide, as measured by the change~     from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) total score at 24~     hours post first dose.~   "
40304|NCT03039179|"~     The post-operative treatment of pediatric patients operated for the correction of flat foot,~     sees today the use of preformed leg-foot splint (Walker) as an alternative to the application~     of plaster casts. The change of the immobilization system has led to the appearance of~     problems of tolerability in particular in the skin. The aim of the study is to assess whether~     by placing a polyurethane foam dress at the heel in the immediate postoperative period until~     removal of the Walker, the rate of skin lesion and pain is reduced.~   "
40305|NCT03039166|"~     the investigators hypothesize that hub alteration occurs both in diffuse diseases (MS, AD) as~     well as in more 'network specific' diseases (Parkinson, ALS, Epilepsy). This could impact on~     functional dysfunction not directly related to each disease, but that could induce common~     syndrome such as cognitive impairment observed in Parkinson, partial epilepsy or ALS.~      The objective here is to test this hypothesis and provides better understandings on~     pathophysiological processes affecting those highly connected regions in 'diffuse' and~     'focal' neurological diseases.~      The ultimate goal is to identify new clinical targets for trans-nosological approaches (DBS,~     cognitive rehabilitation ...).~      Practically, the investigators will explore 200 patients classified in 5 cohorts of 40~     patients suffering for MS, AD, Parkinson, ALS, Epilepsy, using the last advanced methods to~     assess structural and functional brain connectivity implemented on the human 7T MR scanner~     equipping the CEMEREM (CHU Timone, Marseille, only 50 similar MR scanners worldwide).~      In addition to high resolution diffusion MRI and rs-fMRI, metabolic and ionic (sodium)~     mapping will complement the MR protocol to characterize the pathophysiological processes of~     hub injury. Sixty healthy controls will also be explored wih the same protocol for normal~     database.~      The proposal aims at characterizing and comparing from a morphological-functional point of~     view, the hub regions of patients suffering from these five diseases, to demonstrate the~     pertinence to preserve hub integrity as a major therapeutic target whatever the disease.~   "
40306|NCT03039153|"~     From the point of view of nursing to know exactly the different risk factors for the onset of~     pressure ulcers is very important as it allows to accurately orient preventive care~     interventions.~      All the variable that could influence the development of pressure ulcer in patients~     undergoing knee replacement surgery are identified and collected: age, sex, body max index,~     risk to develop Pressure Ulcer (braden score), treatment to prevent pressure ulcers (typology~     of the devices used, such as air mattresses with alternating or static pressure, heel drains,~     frequency of mobilization carried out by both the patient care), management of eventual~     incontinence (use of diapers, urinary catheter), type of anesthesia, type of analgesia,~     length of stay, the ASA physical status classification system (ASA score), comorbidity,~     cancer, use of devices for controlling the position of the operated limb (foam valve), the~     number of physical therapy sessions actually carried out.~   "
40307|NCT03039140|"~     This clinical trial studies a cardiac rehabilitation program in improving cardiorespiratory~     fitness in stage 0-III breast cancer survivors. Cardiovascular disease is the leading cause~     of death of women in both the general population and the breast cancer survivor population.~     There are many risk factors common to both heart disease and breast cancer development,~     including physical inactivity. A cardiac rehabilitation program may help improve~     cardiorespiratory fitness, reduce cardiovascular disease risk factors, and improve quality of~     life among breast cancer survivors.~   "
40308|NCT03039127|"~     Thermotherapy is a technology aiming at destroying tissue, for example tumor tissue.~     Immunostimulating Interstitial Laser Thermotherapy (imILT) is a specific form of~     thermotherapy, which, in addition to destroying tumor tissue, has been optimized to cause a~     tumor specific immunologic response. In laboratory animals the imILT method has also been~     shown to induce a so called abscopal effect. This means that when one tumor is treated with~     imILT other, untreated, tumors also decrease in size. The immunologic response has previously~     been characterized in breast cancer patients after receiving imILT treatment , and presumed~     abscopal effects induced by imILT have also been described in a malignant melanoma patient.~      The purpose of this trial is to investigate the functionality and safety of the imILT~     treatment method in patients diagnosed with breast cancer.~      The treatment method has successfully been used for treatment of patients with breast cancer~     and malignant melanoma. Treatment of breast cancer patients caused an increase of cytotoxic T~     lymphocytes in the treated tumor, as well as activated dendritic cells at the tumor border.~     Regulatory T lymphocytes decreased in the regional lymph nodes.~      This trial is explorative, prospective, open and non-randomized. Five breast cancer patients~     will be treated in this trial, which is estimated to be carried out during a time period of 9~     months.~   "
40315|NCT03039036|"~     Amniotomy (breaking the bag of water) is commonly used in the induction of labor. However,~     the timing is highly variable. The purpose of this study is to determine if first time~     mothers undergoing induction of labor with a Foley catheter experience a decrease in their~     labor time when undergoing early amniotomy (breaking the bag of water within 1 hour of Foley~     catheter removal) than when undergoing delayed amniotomy (breaking the bag of water at least~     4 hours after Foley catheter removal). Other aims include the relationship between timing of~     amniotomy and cesarean section, postpartum hemorrhage, intrauterine infection, neonatal Apgar~     score <7 at 5 minutes, neonatal need for intensive care.~      The investigators hypothesize that induction of labor with Foley catheters followed by early~     amniotomy will result in a decreased duration of labor compared to those who undergo delayed~     amniotomy.~   "
40316|NCT03039023|"~     The investigators are interested in learning more about choline, a nutrient required by the~     body. The body does make some choline, but it does not make enough to support health and the~     rest must be acquired through diet. Eggs, and especially egg yolks, are a major dietary~     source of choline. Choline can also be given as a dietary supplement. Ingestion of choline~     supplements has been linked to an increased concentration of a compound called TMAO~     (trimethylamine N-oxide). Elevated TMAO levels have been linked to higher heart disease risk.~     With this study, the investigators hope to learn whether there is a difference in the way~     your body responds to the ingestion of a choline supplement versus the choline found within~     eggs.~   "
40317|NCT03039010|"~     Swedish Quality Registry for dental health care (SKaPa) is a national registry that has since~     year 2008 gathered dental data. The data is automatically extracted from the patients'~     electronical dental data records. A vast majority of the public dental health care clinics~     deliver data on a daily basis (SKaPa, 2013). SKaPa has the purpose to improve and develop the~     quality of care and patient outcomes for both prevention and reparative/restorative methods~     concerning caries and periodontal disease. For children and adolescents, it is above all~     information related to dental caries that is collected (SKaPa, 2013). So far, SKaPa has~     published seven annual reports. In the report for year 2013 a limited information about the~     status of children was given, due to uncertainty in the quality of the information that is~     passed on to SKaPa (SKaPa, 2013). There is therefore a need to examine the validity of the~     data supplied to SKaPa.~      Tooth decay is the most common disease in children and adolescents that often lead to~     invasive interventions and pain. There are reports of great social disparities in dental~     health in children and adolescents in Sweden (The National Board of Health and Welfare,~     Socialstyrelsen, 2013). Because tooth decay is a common disease in children, it is important~     to be able to monitor the occurrence of the disease and also examine how it differs across~     various groups of children and adolescents. This is now possible through the several~     registries that are available in the dental and health care. Register-based research will be~     an important tool to ensure that children and adolescents receive oral health and dental care~     on the same premise as others, provided the data in the registries are valid. Furthermore,~     register-based research is important for development and quality assurance of dental care.~   "
40318|NCT03038997|"~     To evaluate cardiac MRI and/or serum biomarkers for detecting cardiac cardiac toxicity in~     children who received anthracycline based chemotherapy (ABC).~   "
40319|NCT03038984|"~     This study is a side protocol/extension of 10 years of ClinicalTrials.gov ID: NCT02492555.~     The purpose of this study is to determine if the IBD patients doing home monitoring~     (screening themselves on demand (OD) or every 3 months) have relative reduced rates of~     colectomies, resections, mortalities and cancer after 11 years of web monitoring. The IBD~     patients are self-monitoring by web apps consisting of a short disease activity questionnaire~     (DA) and fecal calprotectin (FC) on any smart phone.~   "
40320|NCT03038971|"~     A safety study conducted on subjects ≥16 years old evaluating the safety of 4 intralymphatic~     injections of 2 different dose levels of the investigational short and tall ragweed product.~     Biomarkers will be assessed at baseline and at multiple time points post-treatment.~   "
40321|NCT03038958|"~     This study compares intrathecal 1% plain chloroprocaine with intrathecal 2% hyperbaric~     prilocaine for patients undergoing ambulatory knee arthroscopy in terms of efficacy and side~     effects~   "
40322|NCT03038945|"~     Total laparoscopic hysterectomy is a procedure that is performed each time more often. One of~     the problems described for this procedure has to do with the closure of the vaginal vault,~     increased surgical time when suture laparoscopically, complications such as dehiscence of the~     dome, infections, hematomas and dyspareunia. A prospective study will be conducted to compare~     two different techniques for closure of the vaginal vault.~   "
40323|NCT03038932|"~     Atopic dermatitis, also called eczema, is a disease with dry, scaly, itchy skin. Those with~     atopic dermatitis may have complications from skin infections such as eczema herpeticum after~     herpes simplex virus (HSV) infection. Symptoms of eczema herpeticum include fever and~     clusters of itchy blisters which crust over and form sores. Although exposure to HSV is~     widespread, most people clear the virus and only a subset of individuals with atopic~     dermatitis develop eczema herpeticum.~      The purpose of this study is to determine why some individuals with atopic dermatitis are at~     higher risk for recurrent skin infections with HSV. The study team will compare how people~     with atopic dermatitis with a history of recurrent eczema herpeticum, people with atopic~     dermatitis without a history of eczema herpeticum, and people without atopic dermatitis~     respond to HSV.~   "
40324|NCT03038919|"~     The researchers intend to investigate possible anabolic effects of bi-weekly exogenous~     testosterone administration during intensive care unit (ICU) stay for up to 8 weeks. Control~     group will receive standard ICU management and will also be followed during ICU stay.~   "
40325|NCT03038906|"~     The proposed work will determine the effect of neuromuscular blockade on physical function~     and recovery in patients with ARDS. The investigators will conduct a prospective ancillary~     study at five PETAL clinical centers that will evaluate the neuromuscular structure and~     function of ROSE (Reevaluation of Systemic Early Neuromuscular Blockade) patients during and~     after critical illness, including in-person assessments at 6 months after hospital discharge.~     The investigators hypothesize that patients randomized to NMB will have an increase in~     ICU-acquired neuromuscular dysfunction during and after critical illness.~   "
40330|NCT03038841|"~     To test the potential and acceptance of wireless activity tracking in palliative care~     patients leaving hospital care. Explorative study, collaboration project of the Clinic of~     Radiation-Oncology, University Hospital Zurich and the Wearable Computing Laboratory, Swiss~     Federal Institut of Technology. Patients receive a tracking bracelet and a smart phone in~     order to gather objective physical activity parameters as step count, sleep duration, heart~     rate, social activity patterns (e.g. making calls) as well as subjective ratings of pain and~     distress. Quality of life (QoL) will be captured by paper questionnaire. Correlations between~     patients' physical activity patterns and the pain and distress level assessed from electronic~     scales as well as QoL-questionnaire will be performed. Acceptance will be evaluated by~     quantitative questionnaires and interviews. The proposed study is meant to be preparatory~     work for an intervention study to test the effect of wireless monitoring of palliative care~     patients on fostering early interventions for symptom relief and support of QoL.~   "
40331|NCT03038828|"~     Study is a dose escalation study. Fifteen patients will be enrolled in 2 treatment cohorts.~     Five participants (cohort A) will be treated with 200IU Multikine daily, 5 days/week for 2~     weeks, off 2 weeks, then again 5 days/week for 2 weeks. If no serious adverse events are~     noted in cohort A patients, ten participants will be treated in cohort B. Cohort B~     participants will be treated the same as cohort A participants except that dose will be~     increased to 400IU Multikine per day.~   "
40332|NCT03038815|"~     After an ankle injury like distorsions, fractures or arthrodeses, or congenital defects ankle~     support limit the range of motion in the joint, help pain relief, control loading of the~     injured tissues and promote recovery of a normal gait pattern. Gait analysis is applied in~     orthopedics, sport science and rehabilitation. Numerous measure systems and methods enable~     accurate analysis of human movement.~      The study is set to describe and compare the gait analysis of two modifiable stability boots~     (Ortho® Tri-Phase and the VACOped®) on the standard walking parameters during two conditions~     (level and ramp walking) in healthy adults and draw comparisons with a control indoor shoe.~   "
40333|NCT03038802|"~     This is a pilot study to determine the safety and efficacy of a novel adjuvanted hepatitis B~     virus (HBV) vaccine formulated as a potential therapeutic vaccine against chronic HBV~     infection. An ongoing human clinical trial of this HBV vaccine in a prophylactic setting has~     confirmed this vaccine to be more effective at inducing seroconversion as measured by~     development of Hepatitis B surface antibody (HBsAb) in poor responder subjects than the~     standard alum-adjuvanted HBV vaccine, providing promise that this new vaccine may also be~     able to induce HBV viral control and/or seroconversion in chronically infected subjects~   "
40334|NCT03038789|"~     This is a local, prospective, non-interventional, regulatory postmarketing surveillance~     study. Adult patients with type 2 diabetes mellitus who are initiating Xigduo XR as indicated~     by the Ministry of Food and Drug Safety (MFDS) will be included.~   "
40335|NCT03038776|"~     Recombinant H7 (rH7) vaccine has been shown to be poorly immunogenic in previous human~     clinical trials. This study will test approaches to improve the immunogenicity of H7 vaccine,~     namely use of a three dose regimen, use of a modified H7 HA sequence from which the Tregitope~     has been removed (rH7m), and inclusion of delta inulin adjuvant adjuvant in the vaccine~   "
40336|NCT03038763|"~     The investigators aim to determine the prevalence of hepatitis C in the adult children of~     female baby boomers. During the years baby boomers were becoming pregnant, hepatitis C~     testing was either not available or was not standard of care. Because of this, participants'~     children may be unaware of participants' risk of hepatitis C.~   "
40337|NCT03038750|"~     The risk of cardiovascular disease is determined by the complex interplay between an~     individual's genetic make-up, lifestyle, and the environment. We are investigating three~     potential genetic risk factors in this observational, cross-sectional, epidemiology pilot~     study to investigate if and how functional variants identified in large-scale genome wide~     association studies can explain a predisposition to cardiovascular disease. By determining~     the molecular mechanisms that are regulated at the EDNRA, PNPLA3 and PROCR CVD risk loci, we~     hope to translate findings from this study into the clinical setting for better diagnosis,~     prevention and treatment for patients suffering with cardiovascular disease. Volunteers will~     enter into one of the study's three arms based on their genotype: EDNRA locus (Arm 1), PNPLA3~     locus (Arm 2), or PROCR locus (Arm 3).~      Members of the Cambridge Bioresource who match for the target alleles will be invited to~     participate and will enter into one of the three study arms. All study assessment visits will~     take place at Addenbrooke's Hospital in collaboration with the University of Cambridge.~      Volunteers will participate in the study for a maximum of 12 months and depending on study~     arm they are assigned to, they will complete procedures including a medical, demographic and~     lifestyle factors questionnaire; height, weight and body fat assessments; in addition to~     blood pressure/heart rate measurements. Minimally invasive procedures including forearm blood~     flow and venepuncture will be performed to assess the primary objectives of the study.~      The hypothesis for arm 1 is that the genetic variant we are investigating at the EDNRA gene~     locus alters the function of the endothelin receptor A leading to an increased risk of~     coronary artery disease and large artery stroke.~      For study arm 2, we hypothesize that the genetic variant we are investigating in PNPLA3 will~     increase the risk of Non-alcoholic fatty liver disease but reduce the risk of Coronary Heart~     Disease.~      For study arm 3, we hypothesize that the genetic variant we are investigating in the PROCR~     locus triggers molecular events that potentially increase the risk of Venous~     Thrombosis/Venous Thromboembolism nut reducing blood pressure. Furthermore we aim to~     investigate the anti-inflammatory effects to see if there is an effect on explaining reduced~     risk of CHD.~      This study is funded from the BHF Cambridge Center of Excellence and the Wellcome Trust~     Institutional Strategic Support Fund.~   "
40338|NCT03038737|"~     The aim of the present study is to evaluate the biting force of upper removable partial~     denture constructed from two different flexible thermoplastic materials.~   "
40339|NCT03038724|"~     A randomised, single-blind study (the study investigator will not know which arm each patient~     is assigned to) conducted to examine the most effective strategy for conducting HIV testing~     in the Emergency Department (ED) using an electronic tablet. The study will take place in the~     ED at Lausanne University Hospital (LUH) between August and December 2015 in the context of~     the Masters project of a medical student studying at the Faculty of Medicine at Lausanne~     University.~   "
40340|NCT03038711|"~     The purpose of this study is to understand if multiple oral doses of BMS-986166 are safe and~     well tolerated in healthy patients.~   "
40356|NCT03038503|"~     The ICU mortality rate of patients with septic shock was still high upto 54.1%.In first 6~     hours of resuscitation, the goals of resuscitation in sepsis shock after adequate fluid~     resuscitation is MAP ≥65 mmHg. In refractory septic shock patient, prolong shock correlate~     with poor outcome due to multiple organ failure. Alternative vasopressor in septic shock with~     catecholamine resistance has been studied such as terlipressin, methylene blue~        -  Terlipressin (TP) mediate vasoconstriction via V1 receptors coupled to phospholipase C,~          and increases intracellular Ca2+ concentration~        -  Methylene blue (MB) directly inhibits nitric oxide synthase (NOS) by inhibit the enzyme~          guanylate cyclase (GC)~   "
40341|NCT03038698|"~     Pulmonary function testing is the most widely used tool for the diagnosis, severity~     assessment, management, risk factor categorization and follow-up of individuals with chronic~     lung disease. Africa has a high burden of infectious respiratory diseases which include~     tuberculosis, asthma and human immunodeficiency virus-related lung disease. Coupled with this~     is an increasing burden of non-communicable respiratory diseases; which include chronic~     obstructive pulmonary disease, emphysema, bronchiectasis and asthma. A proviso to the use of~     lung function testing is the determination of normal values; which are determined for age,~     gender, height and ethnicity for the relevant population. It is well recognised that the~     comparison of an individual patients' results to an ethnically inappropriate population may~     lead to the under or -over diagnosis of disease, inappropriate treatments and result in~     increased burden on individuals, their families and the healthcare system.~      The investigators therefore propose to conduct a prospective well-designed study to include a~     representative sample of both adults and children (4000); to verify the validity of the~     retrospective pilot data, in a South African population.~   "
40342|NCT03038685|"~     The Belgian Stroke Council initiated a project to improve risk factor control and medication~     adherence in ischemic stroke patients by developing an individualized in-hospital initiated~     and post- discharge, digital coaching program addition to standard practice (strokecoach.be).~   "
40343|NCT03038672|"~     This randomized phase II trial studies how well nivolumab with or without varlilumab works in~     treating patients with aggressive B-cell lymphomas that have come back or do not respond to~     treatment. Monoclonal antibodies, such as varlilumab and nivolumab, may work by stimulating~     the immune system to attack cancer tumor cells.~   "
40344|NCT03038659|"~     Erectile dysfunction.~   "
40345|NCT03038646|"~     -  To evaluate the pharmacokinetic (PK) profiles of MIN-l0l following administration of~          modified release (MR) formulations of MIN-l0l in healthy male and female subjects~        -  To select 1 MR formulation for use in fed state~        -  To evaluate the effect of food on the bioavailability of MIN-l0l selected MR formulation~   "
40346|NCT03038633|"~     This is a Phase 1 clinical trial designed to evaluate the safety and tolerability of a novel~     medical food utilizing a nutritional strain of yeast for management of Iron Deficiency~     Anemia.~   "
40347|NCT03038620|"~     This study is a clinical study to investigate the efficacy of liraglutide compared to placebo~     in reducing visceral adiposity measured by MRI in overweight or obese subjects at high risk~     for cardiovascular disease after 40 weeks on-treatment.~   "
40348|NCT03038607|"~     Intrauterine growth restriction refers to a fetus that has failed to get a specific measures~     by a gestational age. Asymmetric type of Intrauterine growth restriction is known by normal~     sized head with smaller abdomen.It is important to recognize the growth restricted fetuses,~     because these fetuses may have fetal or neonatal complications.~      When blood flow is increased, the oxygen and nutrients will deliver good to the fetus. The~     role of low-dose aspirin therapy in management of intrauterine growth restriction is~     controversial. It has been used, in many studies, in prevention of intrauterine growth~     restriction especially in women at high risk of pre-eclampsia or obstetrical antiphospholipid~     syndrome.~   "
40349|NCT03038594|"~     The investigators have previously demonstrated that burn injury causes severe muscle wasting,~     weight and height retardation, and systemic protein catabolism in pediatric and adult burned~     patients. The persistent loss of muscle impairs the quality of life of the burned patients,~     and it also delays autonomy and reintegration into the community. In 2009, the investigators~     showed that the daily injection of recombinant human growth hormone (GH) for nine months post~     discharge significantly increased height and weight, as well as lean body mass, in pediatric~     burned subjects. Our long-term goal is to improve the quality of life of burn patients by~     preventing height, weight, and muscle loss that may occur from severe protein catabolism. The~     objectives of this application are to a) attenuate height and weight in burned patients with~     the administration of GH, b) prevent or reverse loss of muscle and strength in these~     patients, and c) collect pilot data about cardiopulmonary parameters, scar assessments, and~     muscle metabolism. Our central hypothesis is that the administration of GH will restore~     depleted levels of growth hormone and will lead to prevention of lean body mass loss and bone~     mineral content, improve rehabilitation, and accelerate reintegration of severely burned~     patients. The investigators will administer either placebo or GH (daily subcutaneous~     injections of 0.05 mg/kg/day of GH [somatropin, Genotropin, Pfizer, New York, NY] to adult~     burn subjects (n=31 per group, 18-85 years, >30% total body surface burns) for nine months~     beginning one week prior to discharge. Both groups will be studied for a total of two years.~     The following aims will be tested: 1) determine the effects of GH supplementation on body~     composition, such as lean body mass loss, muscle strength, and exercise endurance; and 2)~     assess whether rehabilitation and subsequent reintegration of severely burned patients into~     society can be accelerated. Investigators will measure changes in lean body mass, muscle~     strength and exercise endurance during the acute hospital stay, discharge, and long-term~     follow-up visits (6, 12, 18, and 24 months after burn), as well as secondary endpoints such~     as cardiopulmonary variables, hypertrophic scar development, muscle protein synthesis and~     breakdown rates, quality of life questionnaires, and concentrations of relevant hormones,~     cytokines, and oxidative stress markers.~   "
40350|NCT03038581|"~     Self-inflicted wrist injuries require special psychiatric knowledge and tactical skills.~     There is no protocol for treating such injuries. We analyze self-inflicted wrist injuries and~     compare them to traumatic wrist injuries.~   "
40351|NCT03038568|"~     The purpose of the study is to see how measurements of tumor differences vary with slight~     changes in CT scan parameters. Reproducible radiomic features can be extracted for abdominal~     tumors, and specifically colorectal liver metastases, imaged with clinical CT scanners even~     in the setting of variable scan parameters and variable contrast timing. Participants will be~     consented to undergo an additional CT of their abdomen.~   "
40352|NCT03038555|"~     Preeclampsia (PE) is one of a common type of hypertensive disorder complicating pregnancy~     (HDCP). It is a class of clinical syndromes which shows relevant symptoms, hypertension and~     proteinuria after 20 weeks pregnant as main characteristic, and may accompany with fetal~     anomaly and systemic multi-system organs damage. Several complications, such as eclamptic~     seizures, coma, intracranial hemorrhage (ICH), cardiac failure, pneumonedema, hepatic~     failure, kidney failure, placental abruption and disseminated intravascular coagulation~     (DIC), may be threat to the life of the mother as well as fetal. Thus, the disease is one of~     the core issues that cause the maternal and perinatal death. Morbidity of PE is approximately~     3% to 5%. Morbidity has significant differences between different populations. According to~     the data, from 1995 to 2004, HDCP morbidity in four hospitals in Guangzhou was 5.78%, and in~     the HDCP, mild preeclampsia and severe preeclampsia were accounted for 72.22% and 27.78%~     respectively. Meanwhile, HDCP morbidity decreased from 9.4% (1984 to 1989) to 5.57% (1989 to~     1998).~      In 1996, the American Congress of Obstetricians and Gynecologists (ACOG) gave new~     classification of HDCP based on the characteristic of disease symptoms, divide into five~     groups; gestational hypertension, preeclampsia, eclampsia, chronic hypertension complicated~     with preeclampsia and chronic hypertension. The pathogenesis of PE remains unclear so far.~     The frequent sight is that PE caused by multiple reactions by a number of factors affect.~     Physiologically, mainly altered of PE is increased blood viscosity and systemic vascular~     spasm which cause hypoxic-ischemic of multiple key organs, such as the placenta, kidney,~     liver and brain. The research theory includes abnormal trophoblast invasion, immune response~     abnormal or increase, genetic susceptibility, coagulation disorders or thrombophilia,~     abnormal angiogenesis, endothelial cell damage, abnormal levels of carbonic oxide, increase~     of oxygen radical, abnormal metabolism of calcium ion, heterotrophia and so on. However,~     there are numbers of epidemiologic study have analyzed high risk factor of PE which provides~     significant medical evidence of prevention, early diagnosis and early treatment for PE, there~     is only little study focus on susceptibility gene and pathogenic genetic variation. Nowadays,~     there are numerous clinical phenotype are considered to exist, different phenotype gives~     different inheritance and epigenetics. Thus, our group will examine the onset of type and~     characteristics of PE by a retrospective cohort study to discuss if susceptibility gene and~     pathogenic genetic variation were existing in PE patients, also to find the relativity~     between clinical phenotype and genotype. Moreover, this study is trying to reach the effect~     of PE on the patients' health as well as their children. Thus, can predict the health status~     of PE patients and their children, and so can prevent (avoid or delay) of the patients from~     late complications and disease in their children.~   "
40353|NCT03038542|"~     This study evaluates a text messaging intervention through a smokers' quitline. Smokers will~     either receive 30 weeks of tailored, gain-framed text messages or 30 weeks of tailored,~     standard care text messages, both combined with standard quitline treatment. We hypothesize~     that the gain-framed text message intervention will increase cessation rates at 30 weeks as~     compared to standard care text messages.~   "
40354|NCT03038529|"~     Cost Intradiscal injection of ozone-oxygen mixture (O3-O2) which offers a rapid onset~     amelioration of symptoms, with a sustained duration pain relief in low back pain.~      Does change of injection approach make a difference?~   "
40355|NCT03038516|"~     To test the hypothesis that vitamin D treatment during 12 weeks to palliative cancer patients~     can decrease opioid consumption, fatigue and infectious burden and increase quality of life.~   "
40357|NCT03038490|"~     To investigate whether an oral nutritional supplement of a mixture of arginine, glutamine and~     HMB for a maximum period of four weeks is more beneficial than the standard dietary approach~     to the healing of pressure ulcers, and to examine whether the use of it can reduce admissions~     and length of hospitalizations for these patients.~   "
40359|NCT03038464|"~     The two-stage protocol is gold standard in terms of infection control treating prosthetic~     joint infections of total hip and total knee arthroplasty. The antibiotic pause for~     diagnostic reasons before reconstruction (stage two) is discussed concerning persistence of~     infection and development of resistant bacterial strains. Serological markers and synovial~     analysis are common use to exclude persistence of infection.~      The investigators therefore asked 1) is the serological testing of c-reactive protein and~     leukocytes a valuable tool to predict a persistence of infection and 2) what is the role of~     synovial aspiration of PMMA Spacers on hip and knee joints.~   "
40360|NCT03038451|"~     s-amlodipine besylate 2,5 mg tablet will be administered to patients have not received any~     hypertension treatment before or have received any of anti-hypertensive mono-therapy for the~     first four weeks of treatment. By increasing dose, s-amlodipine besylate 5 mg tablet will be~     administered for the last four weeks (4-8 weeks).~   "
40361|NCT03038425|"~     This is a randomized, double-blinded pilot study to determine whether patients undergoing~     ambulatory total knee arthroplasty (TKA) using a subvastus approach benefit from the addition~     of a continuous adductor canal nerve block (cACB) catheter along with an existing multimodal~     approach to postoperative analgesia. Outcomes include the 15-item Quality of Recovery Scale~     (QoR-15) (Miles 2016), pain scores, opioid consumption, opioid-free days, functional outcome~     as measured by the Time Up and Go (TUG) test, patient satisfaction, patient's rating of~     catheter effectiveness, and complications.~   "
40362|NCT03038412|"~     The purpose of this study was to evaluate the applicability of auto-fluorescence imaging~     system to detect and quantify caries and dental plaque. Participants were advised to rinse~     their mouth with distilled water to exclude any chance of fluorescence from food debris. A~     well trained physicist majored in optical spectroscopy captured auto-fluorescence images of~     buccal aspects of two maxillary central incisors and occlusal aspects of four first molars~     from each patient in a dark room. Then they chewed a disclosing agent to assess the Quigley~     Hein plaque index modified by Turesky of each tooth. Furthermore, participants were also~     required to brush their teeth for 3min, then International Caries Detection and Assessment~     System（ICDAS）codes of relevant teeth to evaluate degrees of caries were recorded by an~     experienced dentist using a mouth mirror and explorer. The Spearman rank correlation~     coefficient between colorimetric parameters of fluorescence image and the plaque index and~     ICDAS code were calculated to evaluate the sensitivity and specificity of auto-fluorescence~     imaging system.~   "
40363|NCT03038399|"~     This long-term extension study is an open-label, multiple‑dose study to evaluate the~     long‑term safety, tolerability, efficacy and PD of vamorolone administered once daily by~     liquid oral suspension over a Treatment Period of 24 months to young boys with DMD who~     participated in the VBP15‑002 Phase IIa and VBP15-003 Phase IIa extension core studies.~   "
40364|NCT03038386|"~     Rationale: Gout is a disease with growing incidence and complexity due to increased life~     expectancy, co-morbidity and medication. The disease can be diagnosed by microscopy,~     demonstrating monosodium uric acid (MSU) in synovial fluid of the affected joint or in tophi~     (subcutaneous or peritendinous MSU depositions). In daily practice, however, the diagnosis is~     difficult to ascertain due to sampling error (no synovial fluid acquired because the needle~     was not exactly placed in the affected joint, or the location of the gout might have been~     extra-articular e.g. around tendons) or to a different cause of acute arthritis (e.g.~     infection, reactive arthritis). Recently, Dual Energy CT scan has become available. This~     technique allows the visualization and quantification of MSU. Although imaging modalities~     such as DECT show promise in the classification of gout, the studies to date have been small~     and have primarily involved people with established disease.~      A study with cross-sectional design in which patients for whom the clinical questions does~     this patient have gout? are referred for participation may contribute to assess the value of~     DECT scan in diagnosing acute arthritis caused by gout.~      Objective: Assessment of value of DECT scan in diagnosing acute arthritis, caused by gout.~      Study design: Prospective Study population: Patients with acute mono or oligo arthritis~     without prior diagnosis, the rheumatologist has an indication for diagnostic needle~     aspiration.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: In current daily practice, patients with acute mono- or oligo-arthritis without~     prior diagnosis undergo a diagnostic aspiration of the affected joint. This can be done by~     blind aspiration or ultra sound guided aspiration depending on the judgement of the~     rheumatologist. The aspirated synovial fluid is then assessed by polarized microscopy to~     detect MSU crystals. The diagnostic value of DECT in acute gout attacks had not yet been~     established and is therefore not used in daily practice. In this study all patients undergo~     DECT scan to assess the value of DECT scan in diagnosing acute arthritis caused by gout. If~     the DECT scan demonstrates MSU depositions and the diagnosis of gout was not ascertained~     prior to DECT scanning by MSU crystals in the synovial fluid, then additional ultrasound~     guided aspiration will take place, with knowledge of DECT results, followed by repeat~     microscopy~   "
40365|NCT03038373|"~     The main aim of this study is to elucidate the mechanism of the remission of type 2 diabetes~     in the morbid obese patients after laparoscopic sleeve gastrectomy.~   "
40366|NCT03038360|"~     CardioSAVE is a prospective 12-month controlled longitudinal study for the validation of a~     novel predictive model and a diagnostic tool, for the risk stratification of AMI patients~     undergoing PCI, with a one year follow-up.~   "
40367|NCT03038347|"~     The purpose of this study is to determine whether a web-based training program with~     text-based information as well as practical exercises can improve cross-cultural competencies~     in therapists.~   "
40368|NCT03038334|"~     This study is to examine the possible effect of supplementing Magnesium sulfate on patients~     with Alzheimer Disease (AD) in controlling or reducing the amount of amyloid present in the~     brain, and increasing cognitive ability in individuals that have amyloid deposits.~   "
40369|NCT03038321|"~     Compare the different supposed clinical treatment of side effects associated with~     intravesical BCG by levofloxacin (quinolones) vs solifenacin (selective anti-muscarinic) vs~     lornoxicam (NSAID)~   "
40370|NCT03038308|"~     The purpose of this study is to evaluate the use of the non-ergoline dopamine agonist~     ropinirole for the treatment of hyperprolactinemia in patients with idiopathic~     hyperprolactinemia and prolactinomas.~   "
40371|NCT03038295|"~     The purpose of this study is to evaluate the safety and efficacy of oral/local propranolol in~     preterm newborns who diagnosed as early phase of retinopathy of prematurity (ROP).~   "
40372|NCT03038282|"~     The effect of Chromium to improve glucose levels in Alzheimer Disease (AD) is controversial.~     The hypothesis of the study is to evaluate the effect of supplementing the AD individuals~     with Chromium combined with exercise and assessing the effect of the supplementation on~     glucose metabolism.~   "
40373|NCT03038269|"~     The purpose of this study is to improve arm function in adults with hemiplegic cerebral~     palsy. Participants will receive transcranial direct current stimulation (or sham) in~     combination with upper extremity robotic therapy.~   "
40374|NCT03038256|"~     The purpose of this study was to evaluate the effect of concurrent capecitabine-based~     long-term radiotherapy followed by 4 cycles XELOX pre- a delayed TME compared with 6 cycles~     XELOX post- a Regular Timing TME in patients with high-risk rectal cancer defined by MRI.~   "
40375|NCT03038243|"~     This is a research study about an experimental (investigational) oral inactivated whole cell~     Shigella flexneri 2a killed vaccine (Sf2aWC) and an adjuvant called dmLT. Sf2aWC is a killed~     vaccine that is being made to prevent disease from Shigella., which causes bloody, watery~     diarrhea. An adjuvant is something that is added to a vaccine to make it work better. The~     purpose of the study is to see if the vaccine will protect people from Shigella infection~     with or without an adjuvant called dmLT. About 72 healthy adults, ages 18-45, will~     participate in this study. The study will compare 2 different vaccination groups and 1~     control group. Volunteers have an equal chance to be in any of the 3 groups. Study procedures~     include: stool samples, blood samples and documenting side effects. Participants will be~     involved in study related procedures for about 6 months.~   "
40376|NCT03038230|"~     This is a First-in-Human, single arm, open-label, multi-national study designed to determine~     the safety, tolerability and preliminary efficacy of MCLA 117.~   "
40377|NCT03038217|"~     In this study, we aim to investigate the value of circulating tumor DNA (ctDNA) analysis in~     the diagnosis, treatment, and surveillance of patients with surgically resectable colorectal~     cancer, by performing serial analysis of ctDNA, next-generation sequencing of surgical~     specimens, and observation of patients undergoing radical resection of the tumor with or~     without adjuvant chemo- and/or radiotherapy.~   "
40378|NCT03038204|"~     Recent publications show that an adjunctive subvalvular repair during mitral annuloplasty for~     secondary mitral regurgitation effective in preventing recurrent regurgitation. One of these~     procedures is the papillary muscles approximation. However, the safety and the positive~     impact of this method are still in doubt.~   "
40379|NCT03038191|"~     Epilepsy is a group of neurological disorders characterized by propensity for spontaneous~     epileptic seizures. Epileptic seizures are the result of excessive and abnormal nerve cell~     activity in the brain. About 0.7-1% of the world population suffers from seizures. The most~     common treatment is based on seizure medications that enables about 2/3 of the patients to~     control their seizures. However, about 20 million patients worldwide, suffer from~     unpredictable seizures without remedy, and are resistant to medication.~      In this study EEG and other physiologic signals are collected using wearable sensors, from~     Epilepsy patients who are at risk of experiencing seizures. The collected signals will be~     used for developing algorithms that may identify pre-seizure and seizure related periods.~   "
40380|NCT03038178|"~     The proposed study will assess the efficacy, safety and tolerability of once daily dosing of~     Liposomal-Amikacin for Inhalation (LAI) 590 mg for 12 months plus standard of care (SOC)~     mycobacterial multi-drug regimen in accordance with the 2007 ATS/ IDSA guidelines, for~     treatment of mycobacterium abscessus lung disease.~   "
40381|NCT03038165|"~     While the exact pathogenesis of Intradialytic hypertension remains to be determined, several~     mechanisms were proposed to be involved. The main factors to determine the arterial blood~     pressure are the peripheral vascular resistance and cardiac output. The assumption is that~     the increase of blood pressure is related to the increase in peripheral vascular resistance~     during the dialysis session, due to fluid removal and fast reduction of the intravascular~     volume reduction.~      Using the NICAS device (Non-Invasive Cardiac System), the hemodynamic profile in patients~     with intradialytic hypertension will be evaluated~   "
40382|NCT03038152|"~     The goal of this clinical research study is to learn more about the safety and effectiveness~     of a marker called Magseed that is used to help participant's doctor locate lymph nodes that~     contain cancer under participant's arm during surgery. The Magseed marker is a small metallic~     marker (smaller than a grain of rice) which is placed in or near the lymph node by~     participant's radiologist.~      This is an investigational study. The Magseed marker has been FDA approved to locate breast~     tumors. It is investigational to use the marker to locate lymph nodes that contain cancer so~     that the doctor can remove them.~      Up to 50 participants will take part in this study. All will be enrolled at MD Anderson.~   "
40383|NCT03038139|"~     The purpose of this study is to investigate the changes of spinal muscle activation in~     cervical, thoracic and lumbar segments for subjects with forward head posture (FHP) after~     application of two correction programs; a conventional one including cervical and thoracic~     spine, and a second program involving lumbosacral segment.~   "
40384|NCT03038126|"~     Home telehealth monitoring of veterans with chronic kidney disease, with a disease management~     protocol and safety-specific decision support, will increase the detection of adverse safety~     events, and in turn, reduce the need for urgent health resource utilization and associated~     poor outcomes.~   "
40385|NCT03038113|"~     This randomized study will be conducted in two parts to evaluate the safety, tolerability,~     pharmacodynamics, and pharmacokinetics of subcutaneous administration of RO7062931. Part 1~     will include only healthy participants and Part 2 will include only participants with chronic~     hepatitis B (CHB). Part 1 is an adaptive, single-ascending dose study with an adaptive~     dose-escalating schedule to determine the best dose to be evaluated in participants with CHB.~     Part 2 is an adaptive, parallel multiple-dose study comprised of two sub-parts which will be~     used to further refine the dose and dosing regimen.~   "
40386|NCT03038100|"~     This is a Phase III, global, double-blind, 2-arm randomized study designed to compare the~     efficacy and safety of atezolizumab + paclitaxel + carboplatin + bevacizumab versus placebo +~     paclitaxel + carboplatin + bevacizumab. Study participants will have Stage 3 or 4 ovarian~     cancer (OC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) with macroscopic~     residual disease postoperatively (i.e., after primary tumor reductive surgery) or who will~     undergo neoadjuvant therapy followed by interval surgery.~   "
40387|NCT03038087|"~     The purpose of this research study is to find out whether a device for monitoring bleeding in~     patients with acute hemorrhagic stroke will show similar findings as CT scans performed to~     evaluate the stroke.~   "
40388|NCT03038061|"~     Position of diaphragm in the region of electrical impedance tomography measurement is to be~     determined by ultrasound in approx. 20 patients undergoing laparoscopic surgery. Data are to~     be obtained at three phases at supine horizontal position (during spontaneous breathing, at~     mechanically ventilated patient under general anesthesia with muscle relaxation and at~     mechanically ventilated patient under general anesthesia with muscle relaxation during~     insufflation of carbon dioxide into the peritoneal cavity to achieve exposure during~     laparoscopic surgery).~   "
40390|NCT03038035|"~     MLC601 (Neuroaid) is a Traditional Chinese Medicine (TCM) having neuroprotective and~     neuroproliferative properties in cellular and animal models of brain injury. It contains 9~     herbal and 5 non-herbal components. MLC901 (Neuroaid II), a simplified formula of MLC601,~     containing only the 9 herbal components yet showing the same efficacy has become available.~      This study is carried out to find out if NEUROAID II (MLC901) is safe to be taken together~     with other established medicines for Alzheimer's disease and whether NEUROAID II (MLC901)~     helps in slowing down the Alzheimer's disease progression.~      This study will be a 6-month randomized, double-blind, placebo-controlled trial, followed by~     an open extension study in which all subjects who completed the main 6 month trial~     (irrespective of treatment allocation) will be offered open-labelled MLC901 for another 6~     months.~   "
40391|NCT03038022|"~     The primary objective of this study is to determine the effect of once-daily oral MGL-3196 on~     the percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients~     with Heterozygous Familial Hypercholesterolemia (HeFH).~   "
40392|NCT03038009|"~     The purpose of this study is to determine whether 12-month prophylactic treatment with~     pantoprazole is superior to 1-month therapy without major cardiovascular events (MACE)~     increased significantly, in prevention of dual antiplatelet therapy (DAPT)-induced upper~     gastrointestinal (GI) mucosal injury after coronary artery bypass graft (CABG) surgery. The~     potentially serious harm of DAPT on gastroduodenal mucosa will be assessed by~     esophagogastroduodenoscopy (EGD).~   "
40393|NCT03037996|"~     Annually, the Department of Anesthesiology, Siriraj hospital has responsibilities to take~     care of more than 50,000 patients peri-operatively. According to Maslow's hierarchy of needs;~     human's pleasure is classified as physiological, safety, belonging, esteem and~     self-actualization. Since defining and measuring quality of healthcare service is an~     inevitable challenge for all institutes in medical fields, a questionnaire is developed to~     assess the quality of all services. The Siriraj Anesthesia Quality Assessment Questionnaire~     (Si-2-AQ), a simply 40-item tool in seven dimensions, comprises Accessibility and~     convenience, Communication and Information, Process of care, Technical Quality, Psychological~     support, Physical support and Royalty.~   "
40394|NCT03037983|"~     The purpose of this study is to determine whether repetitive transcranial magnetic~     stimulation (rTMS) is effective in remediating cognitive deficits while also improving~     functionality in Veterans with schizophrenia.~   "
40395|NCT03037970|"~     ABSOLVE Biologic Wound Matrix is a combination of recombinant human platelet-derived growth~     factor BB homodimer (rhPDGF-BB) and a bovine type I collagen wound dressing matrix. ABSOLVE~     is under development for the treatment of chronic and acute wounds. This study investigates~     the safety and efficacy of ABSOLVE in chronic diabetic foot ulcers (DFUs).~   "
40396|NCT03037957|"~     A multi-center evaluation to assess the diagnostic sensitivity and specificity of the ARIES~     Group A Strep Assay will be established through a method comparison using prospectively~     collected, de-identified, clinical samples collected during the enrollment period.~   "
40397|NCT03037944|"~     This study aims to compare the efficacy of LNG - IUD (Levonorgestrel releasing intrauterine~     device) Versus Low dose COCs (combined oral contraceptive pills) on management of heavy~     menstrual bleeding and Dysmenorrhea caused by Adenomyosis.~   "
40398|NCT03037931|"~     The primary objective of this study is to determine the efficacy and safety of iron therapy~     using intravenous (IV) ferric carboxymaltose (FCM), relative to placebo, in the treatment of~     participants in heart failure with iron deficiency and with a reduced ejection fraction.~   "
40399|NCT03037918|"~     Participants will be randomly allocated to either Yakult ingestion or a control group. For~     the first 20 days, subjects will consume their normal diet (keeping a detailed food diary~     throughout). On days 21-28 they will switch to a high-fat/high-calorie diet.~      The investigators hypothesise that consuming a high-fat, high-energy diet for 7 days will~     alter the composition of the gut microbiota and induce metabolic endotoxaemia / systemic~     inflammation as well as decreasing whole body insulin sensitivity (as we have shown~     previously). In contrast, the investigators hypothesise that consuming Yakult for 21 days~     before and 7 days throughout the high-fat diet will maintain a favourable gut microbiota and~     prevent metabolic endotoxaemia / systemic inflammation and thus maintain insulin action /~     insulin sensitivity.~   "
40400|NCT03037905|"~     Anxiety prior to surgery is an expected emotion. Research has not been conducted on methods~     to reduce anxiety in the operating room itself. STERIS Corporation has developed an automated~     surgical suite environmental system, called SignatureSuite™, that controls the level of~     lighting, images on OR monitors, and ambient background audio via preset, computerized~     automation for use before and after anesthesia. This study aims to determine if this new type~     of operating room environment decreases anxiety, as measured by patient responses on anxiety~     visual analog scales, heart rate, systolic blood pressure, and postoperative analgesic use.~     The proposed study will be a two-arm, randomized controlled trial comparing anxiety levels~     for patients that have thyroid or parathyroid surgery in the SignatureSuite room at Cleveland~     Clinic Marymount Hospital versus the standard operating room environment. Randomization will~     occur at the surgeon level. There will be a maximum 100 patients divided equally between the~     experimental and control arms of the study.~   "
40410|NCT03037775|"~     It is intended to examine 50 healthy volunteers aged 18 - 60 years. 12-hour abstinence from~     tobacco smoke, alcohol or coffee before the experiment will be required. The exclusion~     criteria are medical history of stroke, coronary artery disease, chronic heart failure,~     hypertension, peripheral vascular disease, atrial fibrillation, polyneuropathy, obesity (BMI>~     30 kg/m2), the current active disease (eg. viral infection). Test subjects will actively~     inhale for 10 minutes tobacco or the e-cigarette smoke with nicotine fluid (18 mg/ml) or~     fluid without nicotine for 10 minutes. The study protocol involves random allocation to~     groups exposed to electronic or traditional cigarette smoke in cross-over scheme. The primary~     endpoint is the maximum change in heart rate compared to mean values prior to exposure.~     Secondary end points is the maximum change in the measured parameters (hemodynamic and~     autonomic values) compared to the average values before exposure. The measurements will be~     performed using the Task Force Monitor system for non-invasive measurement of hemodynamic~     parameters and the assessment of autonomic function. Adrenergic activity will be tested with~     microneurography. A periodic analysis is planned after examining 15 and 35 patients.~   "
40401|NCT03037892|"~     Colonoscopy is one of the most commonly performed outpatient procedure for diagnosis and~     treatment of lower gastrointestinal tract disorders. It has been largely accepted as an~     effective tool for colorectal cancer(CRC) screening, given its ability to detect and remove~     identified polyps. Increased colonoscopy utilization is associated with the observed decline~     in the incidence of CRC and its diagnosis at earlier stages. Diagnostic and therapeutic~     colonoscopy can successfully be performed using moderate sedation in the ambulatory setting.~     Techniques of sedation must guarantee the comfort and safety of patients, and at the same~     time allow a rapid turnover of patients.. An anaesthetic agent with rapid onset and offset of~     action, and convenient titration of anaesthetic/analgesic depth as well as rapid recovery to~     enable discharge from the endoscopy unit as soon as possible would be ideal as most such~     procedures are performed in the Non-Operating Room Anaesthesia(NORA) settings.~      There is recent interest in the use of Remifentanil, in endoscopic units as it might have~     advantages over other drugs because of its profound analgesic effects, rapid onset and offset~     time and rapid titration to the individual patient's requirements and intermittent pain~     during colonoscopy.~      The aim of this randomized study is to test the hypothesis that a colonoscopy of good quality~     in terms of pain relief, patient comfort and discharge times with less cardiorespiratory side~     effects can be performed using Remifentanil as a sole agent as compared with the standard~     midazolam/fentanyl protocol. The second group combining Remifentanil with Midazolam is taken~     to evaluate if there is any advantage of adding an anxiolytic amnesic drug as used in the~     standard Midazolam/Fentanyl Protocol.~   "
40402|NCT03037879|"~     Multiple studies in the spinal cord injury (SCI) population have documented deficits in~     learning and memory (LM) and processing speed (PS) that adversely impact daily life and the~     ability to benefit from rehabilitation. The investigators have previously attributed the~     cognitive deficits demonstrated in the SCI population to low blood pressure (BP) and cerebral~     blood flow (CBF) and are currently conducting a study to determine the effect of a 30-day~     elevation in BP (using midodrine hydrochloride - an alpha agonist) on CBF and cognitive~     performance compared to placebo in hypotensive individuals with SCI. In addition, the~     investigators believe that cognitive behavior therapy (CBT) may improve cognition independent~     of changes in BP and CBF in individuals with SCI. The current randomized clinical trial (RCT)~     will examine the efficacy of 2 treatment protocols shown to be effective in improving~     cognitive performance in other neurologically impaired populations for use in persons with~     SCI demonstrating (1) LM impairment and/or (2) PS impairment on objective measures of~     cognitive functioning during a complete Neuropsychological assessment. Two methods of outcome~     assessment will be used to examine treatment impact: (1) a traditional Neuropsychological~     assessment (NP) and (2) an assessment of global functioning (AGF) composed of broader outcome~     measures that examine the impact of the treatment on everyday life activities. In this way,~     the investigators will be able to objectively evaluate the presence or absence of changes in~     memory performance through a NP assessment, while also evaluating the impact of this~     treatment protocol on everyday life through the AGF. While most studies evaluating the~     efficacy of cognitive retraining usually employ a pre- and post-training evaluation, such~     evaluations have been criticized for their lack of ecological validity (i.e., real world~     generalizability). The present design allows the assessment of the efficacy of these~     treatment techniques within an SCI population using traditional measures, as well as the~     assessment of the impact that treatment has on everyday life. The investigators will~     additionally evaluate the long-term efficacy by including a 6-month post-treatment follow-up.~     Few studies examine long-term effects, but given the time, labor and expense involved, it is~     critical to demonstrate long-term efficacy.~   "
40403|NCT03037866|"~     This project is designed to address the urgent need for an effective primary prevention~     approach to the problem of sexual violence among college students. The project involves~     developing, feasibility testing, and testing for effectiveness an innovative new approach to~     the primary prevention of sexual violence, alcohol, and drug abuse among college students~     utilizing both online e-learning and small group facilitator-led intervention modalities. The~     intervention is an adaptation of the successful evidence-based substance abuse and violence~     prevention approach called Life Skills Training (LST). The adapted intervention is designed~     to address the relationship between sexual violence and substance abuse; positively change~     social norms surrounding alcohol/drug abuse and sexual violence; train bystanders to identify~     and appropriately respond to problematic situations; and build social, self-regulation, and~     relationship skills through interactive learning and behavioral rehearsal scenarios. At the~     conclusion of the study, the investigators expect to be able to widely disseminate and market~     a new evidence-based primary prevention intervention for sexual violence for use in a variety~     of higher educational settings.~   "
40404|NCT03037853|"~     The goal is the constitution of a statistical atlas of the human being morphology~     variability.~      This work would be a significant step forward in the field of anatomy and biomechanical~     simulation.~   "
40405|NCT03037840|"~     Studies have shown that tumor specific amplitude-modulated frequencies of radiofrequency~     electromagnetic fields that is associated with biofeedback upon exposure to in cancer~     patients. However, such discovery in other cancer patients are rare. And whether tumor~     specific frequencies can be found in Asian cancer patients remains unclear. The purpose of~     this study is to detect the tumor specific frequencies of Asian cancer patients in vivo.~   "
40406|NCT03037827|"~     A multicenter clinical randomized controlled trial, comparing of three different regimens of~     endovenous laser ablation with equal linear endovenous energy density in patients with~     insufficiency of the great saphenous vein (GSV). The linear endovenous energy density (LEED)~     is the main value for standardization EVLA. From many studies, it is known the optimum value~     of the LEED. However, the same LEED may be obtained by varying the ratio between the laser~     power and the fiber pullback speed. Power decrease can allow to reduce the incidence of~     adverse effects of endovenous laser ablation, but keep high efficiency.~   "
40407|NCT03037814|"~     The purpose of this study is to evaluate and compare the clinical performance of dental~     restorative materials in Class II cavities of primary molar teeth~   "
40408|NCT03037801|"~     Prospective randomized study of patients admitted to the Pediatric Intensive Care Unit~     suffering from Bronchiolitis and are supported on Non Invasive Positive Pressure Ventilation.~     The patient population will be divided into two groups, one group will receive conventional~     treatment and the other group will receive conventional treatment and three times a day of~     physiotherapy using Intrapulmonary Percussive Ventilation.~   "
40409|NCT03037788|"~     The aim of the study is to assess the safety, tolerability, pharmacokinetics (PK) and~     efficacy of escalating concentrations of GPB in subjects with axillary hyperhidrosis.~   "
40425|NCT03037580|"~     This is a multicenter, randomized (1:1; oral treprostinil to placebo), double-blind,~     placebo-controlled study in subjects with World Health Organization (WHO) Group 2 pulmonary~     hypertension (PH) associated with heart failure with preserved ejection fraction (HFpEF).~     Once randomized, subjects will take the initial dose of study drug at the study site on the~     day of randomization. Subjects will return to the study site for visits scheduled at Weeks 6,~     12, 18, and 24. The treatment phase of the study will last approximately 24 weeks.~   "
40411|NCT03037762|"~     Neurogenic dysphagia is one of the most frequent and prognostically relevant neurological~     deficits in a variety of disorders, such as stroke, parkinsonism and advanced neuromuscular~     diseases. Flexible endoscopic evaluation of swallowing (FEES) is now probably the most~     frequently used tool for objective dysphagia assessment in Germany. It allows evaluation of~     the efficacy and safety of swallowing, determination of appropriate feeding strategies and~     assessment of the efficacy of different swallowing manoeuvres. The literature furthermore~     indicates that FEES is a safe and well-tolerated procedure. The FEES-Registry aims at~     evaluating findings and side effects of FEES in a heterogeneous collective of patients with~     neurogenic dysphagia.~   "
40412|NCT03037749|"~     Intimate partner violence (IPV) is a serious public health problem costing $8.3 billion per~     year with over $6 billion in direct medical and mental health costs alone. Alcohol is present~     in most incidents of IPV, and contributes to more frequent and severe IPV incidents. These~     facts, coupled with the fact that there are no effective interventions for IPV, make~     understanding mechanisms through which alcohol is associated with IPV critical.~   "
40413|NCT03037736|"~     This is a randomized controlled trial of postoperative bevacizumab or 5-fluorouracil~     subconjunctival injections vs placebo for the recurrence of pterygia after excision using~     conjunctival autograft.~   "
40414|NCT03037723|"~     Radiation therapy to the breast has remained a standard practice for breast conserving~     therapy. Because of the location of the heart and lungs when patients are positioned face-up,~     whole breast radiation therapy has been reported to increase the risk of damage to the heart~     a few years after treatment until at least 20 years after exposure, and may affect~     cardiovascular mortality. Also, patients receiving whole breast radiation therapy are at an~     increased risk for development of secondary lung malignancies. Recent studies have~     demonstrated a significant reduction in dose to the heart and lungs when treated in the~     face-down position. Similarly, correcting for the movement of breathing (respiratory gating)~     in the face-up position has also become an available option for reducing unwanted dose to the~     heart and lungs, particularly in left sided breast cancers. No study to date has compared~     these newer organ-sparing techniques head-to-head for early stage breast cancer.~      It is institutional policy to perform CT simulation in left-sided breast cancer patients with~     and without the respiratory gating (this is one CT scan), in the face-up position. It is also~     standard of care to perform the face-down CT simulation in large breasted women. Both of~     these simulations are meant to reduce the exposure of the heart and lungs to radiation.~      In this study, all left-sided breast cancer patients that consent will receive face-up CT~     simulation with and without gating AND face-down CT simulation, regardless of breast size;~     thus, each patient is their own control.~      The treating physician will determine which of the two simulations, if any, offers better~     protection to each patients' heart and lungs. Two dosimetrists will be required to~     independently verify planned dosimetry with all treatment setups. Treatment will be planned~     in standard fashion using the best of the two plans.~   "
40415|NCT03037710|"~     This is a multi-center, non-randomized, non-interventional study to evaluate the accuracy of~     a remote monitoring and analytical platform for prediction of heart failure exacerbation. The~     platform acquires continuous multivariate vital signs from HF patients using a new ambulatory~     wearable (attached by an adhesive) multi-sensor device and analyzes the data using a novel~     machine learning algorithm.~   "
40416|NCT03037697|"~     The aim of this study will be to evaluate the effect of TheraTogs orthotic undergarment and~     strapping system on increasing axial stability that will reflect on improving balance and~     walking performance in children with dyskinetic cerebral palsy.~   "
40417|NCT03037684|"~     The aim of the study is to evaluate voltage gated sodium channel (NaV1.7) dependent pain~     phenomena in neuropathic pain and chronic postoperative pain.~   "
40418|NCT03037671|"~     This study is designed to determine feasibility of using a continuous glucose monitor in~     pediatric, adolescent and young adult hematopoietic stem cell transplant (HSCT) recipients,~     and to identify the incidence and risk factors for malglycemia in primary admission for~     pediatric, adolescent and young adult HSCT patients as well as to characterize the~     relationship between outcomes and malglycemia in this population.~   "
40419|NCT03037658|"~     In this study, the investigators will test responsiveness of young, middle-aged, and older~     adults to a range of incentives, some of which provide rewards for the individual~     participants and others that offer rewards to other people or groups. The investigators~     hypothesize that incentives are differentially effective for different age groups.~   "
40420|NCT03037645|"~     Phase 1b (Dose Escalation) in primarily CLL/SLL patients will evaluate safety and~     pharmacology of self-administered twice a day oral doses beginning at 25 mg/dose for 4 weeks~     with succeeding cohorts at escalating doses until establishing dose limiting toxicity or,~     recommended Phase 2 dose. Patient data will be assessed before authorizing dose escalation~     cohorts. Phase 2 (Cohort Expansion) will follow in cohorts using the recommended dose to~     explore clinical activity, safety, pharmacology of SNS-062 (vecabrutinib) as monotherapy.~   "
40421|NCT03037632|"~     The aims of the DCM Precision Medicine Study are to test the hypothesis that DCM has~     substantial genetic basis and to evaluate the effectiveness of a family communication~     intervention in improving the uptake and impact of family member clinical screening.~   "
40422|NCT03037619|"~     Patients undergoing knee replacement typically report improved health-related quality of~     life, increased physical function, and reduced pain. Despite these improvements, physical~     activity levels remain unchanged, or only minimally increase from pre-operative levels, yet~     do not reach the same level of activity observed among healthy populations. Knee replacement~     patients often expect their activity levels and function to improve following surgery, but~     the majority of patients' activity levels 5 years post-operatively did not meet their~     pre-operative expectations. Even though improvements are observed in pain and function,~     reasons for the maintenance of low levels of activity are unknown. Technology has the~     potential to increase physical activity levels in these patients, particularly as 81% of knee~     replacement patients in our recent study had a smartphone, and 40% were willing to wear a~     wrist-worn physical activity monitor. As the average age of knee replacement continues to~     decrease, we anticipate that the percent of patients with a smartphone and willingness to~     wear an activity monitor will increase. In addition to technology, social support is~     associated with greater outcomes following knee replacement. Thus, wearing a wrist-worn~     physical activity monitor and providing additional opportunities for social support via the~     technology may increase physical activity levels in these patients. The current pilot study~     aims to gain preliminary data on the influence of wearables and social support on physical~     activity in knee replacement patients following surgery. Specifically, we aim to recruit 20~     patients who will be randomized to one of two conditions: Fitbit vs. Fitbit+Support.~     Participants in the Fitbit group will receive a Fitbit and be encouraged to wear it for 4~     months. Participants in the Fitbit+Support group will be asked to identify a buddy. Both~     the participant and buddy will be given a Fitbit and they will be asked to friend each~     other via Fitbit and wear the monitor for 4 months.~   "
40423|NCT03037606|"~     It is planned to compare the efficacy and safety of rabeprazole 50 mg DDR (dual delayed~     release) capsules versus rabeprazole 20 mg enteric coated tablets administered once daily in~     patients with Gastroesophageal Reflux Disease (GERD).~   "
40424|NCT03037593|"~     Demonstrate dose-dependent relationship between vitamin D supplementation and rates of~     gestational diabetes.~   "
40426|NCT03037567|"~     The purpose of this study is to examine the acceptability and efficacy of a modified Weight~     Watchers program over 24 weeks. Assessments will be conducted at 0, 3, and 6 months.~   "
40428|NCT03037541|"~     Carac 0.5% cream is approved for daily topical treatment of AK's for up to four weeks as~     tolerated, though local irritation often occurs within the first week of treatment and~     increases in a dose-dependent manner. In this study, the investigators will examine the~     combination of standard cryosurgery treatment followed by a shortened course of topical~     fluorouracil cram. The investigators anticipate that a one week treatment course will~     maintain overall effectiveness when combined with previous cryosurgery, but will reduce the~     overall adverse effects of topical therapy due to the reduced treatment time and the presence~     of fewer baseline lesions to treat. This treatment approach may provide a more acceptable~     risk/benefit ratio option for patients with more extensive disease and simplify standard~     combination treatment options. The primary objective is to evaluate the efficacy of~     combination cryosurgery and 5-fluorouracil0.5% cream, compared to combination cryosurgery and~     placebo in the treatment of actinic keratosis lesions. The efficacy of this combination~     therapy will be evaluated by assessing AK lesion clearance. The primary efficacy parameter~     will be 10% clearance of all AK lesions from treatment initiation to end-of-treatment.~   "
40429|NCT03037528|"~     The goal of the research is to optimize an online and mobile multicomponent 12-month diet and~     lifestyle intervention for improving the blood glucose control of individuals with type 2~     diabetes.~   "
40430|NCT03037515|"~     The purpose of this project is to compare the effectiveness of two different but well~     accepted routes of administration of tranexamic acid in order to reduce blood loss and need~     for transfusion in patients undergoing lumbar spine surgery. Specifically, this study seeks~     to identify if intravenous tranexamic acid is superior to oral tranexamic acid in reducing~     blood loss and need for transfusion.~   "
40431|NCT03037502|"~     If the investigators are to adequately address the health needs of African American and~     Latino men, both culture and gender must be considered when developing and implementing~     strategies to increase their healthy eating and physical activity and decrease tobacco~     use.The aim of this project is to develop and test gendered, culturally and contextually~     relevant messages that will be used in a future, web- based tailored intervention to~     encourage tobacco cessation and increase healthy eating and physical activity in African~     American men. This study is part of a larger research agenda that for a decade has focused on~     understanding and reducing chronic disease risk among African American and Latino men.~     Because men are more likely than women to engage in over 30 behaviors known to increase their~     risk of injury, morbidity, and mortality, improving men's health requires understanding the~     social and cultural factors that help explain sex differences in health. Operationalizing~     gender in individually-tailored health communications has great potential to unlock the~     potential of health communications and interventions to engage and improve the health of men~     and particularly African American and Latino men. To date, no community-based intervention~     has produced clinically significant improvements in weight loss, healthy eating or physical~     activity in Latino and African American men. It also is unclear how technology can be used to~     promote these behaviors in this population. Thus, there is a need to develop healthy eating,~     physical activity and weight loss interventions specifically targeted and tailored to African~     American and Latino men that explores the utility of technology. This intervention content~     and focus represents a novel strategy to promote health equity by using technology-based~     health care innovations to improve healthy eating and active living by addressing a root~     cause of unhealthy behavior in men: notions of manhood. The investigators focus on gender and~     manhood because they are under-explored factors that shape men's health behaviors.~   "
40432|NCT03037489|"~     This is a multicentre, open-label, one-arm Phase II extension study to evaluate the safety~     and tolerability of MIV-711 in patients with knee joint osteoarthritis (OA).~   "
40433|NCT03037476|"~     This research will adapt an evidence based intervention for alcohol and other drugs and~     evaluate its efficacy on Prescription Stimulant Medication (PSM) misuse in web-based and~     in-person formats for use with college students who have misused PSMs.~   "
40434|NCT03037463|"~     The purpose of this study is to assess whether tear secretion in patients with Parkinson's~     disease will be altered to exhibit a characteristic or diagnostic biomarker profile, that~     will be reflected in changes in the protein composition of tear fluid, which can be measured~     relatively easily, cost-effectively, and non-invasively. Tear fluid samples will be collected~     from Parkinson's patients, and through biochemical assays, the profile of proteins in tears~     will be characterized and compared to that from control subjects. The profiles will be~     analyzed with respect to any differences between Parkinson's patients and control subjects.~     If differences appear, the levels of these potential biomarkers in Parkinson's patients will~     be compared to the severity of their disease.~   "
40435|NCT03037450|"~     Neurotrophic keratitis (NK) is a degenerative disease of the cornea due to the impairment of~     the nasociliary branch of the ophthalmic nerve. Reduced corneal sensation lead to several~     corneal lesions including spontaneous ulcerations, delayed wound healing, corneal scarring,~     neovascularization, thinning, perforation or infection. An important and permanent visual~     loss of is frequently associated with the condition. NK can be congenital or acquired. Its~     acquired forms can be due to traumatic, infectious (herpes, zoster), neoplastic or iatrogenic~     causes. There is currently no specific medical treatment. Surgical reconstruction techniques~     of sensory neurotizations have recently been described in young patients suffering traumatic,~     congenital or neoplastic NK using supratrochlear nerves as the sensory donor nerves and sural~     nerve as healthy graft. A neurotization involves the transfer of a healthy donor nerve~     segment into a tissue to reestablish either motor or sensory innervation. The aim of the~     present study is to assess the outcomes of a novel sensory neurotization technique for the~     treatment of severe NK in adult patients (Stages 2 and 3 of Mackie classification). Corneal~     neurotizations will be performed using either ipsilateral supraorbital nerve as donor nerve~     (direct neurotization) or contralateral supraorbital nerve as donor nerve and a segment of~     the lateral antebrachial cutaneous nerve as graft. Small-size skin incisions (less than 3~     centimeters) will be made in one or both eyebrow and an endoscopic device will help the~     surgeons to localize and dissect the supraorbital nerve. Donor nerves or graft will be~     sutured to the neurotrophic corneas. Adult patients with unilateral NK due to infectious,~     traumatic or iatrogenic causes will be included.~   "
40436|NCT03037437|"~     The PI is studying if sorafenib/hydroxychloroquine (HCQ) will have improved efficacy when~     compared to sorafenib alone and in patients progressing of sorafenib the addition of HCQ~     would lead to disease stability in patients with advanced hepatocellular cancer (HCC).~   "
40460|NCT03037125|"~     Split crest technique is a technique for horizontal bone augmentation used in case of narrow~     alveolar ridges as an alternative to the more aggressive techniques such as onlay bone~     grafting, guided bone regeneration (GBR) and distraction osteogenesis~      The study goal is to evaluate whether if there will be any benefit of using platelet rich~     fibrin (PRF) with the split crest technique regarding bone width gain and healing response in~     comparison with split crest technique alone, where PRF is considered an autologous, growth~     factor containing material which is easy to collect and is of low cost.~   "
40437|NCT03037424|"~     This is a pragmatic, prospective, multi-center, randomized, active-control, single-blinded,~     non-inferiority phase 3 trial in adult cardiac surgical patients. Up to 12 Canadian hospitals~     will participate, and the trial will require up to 2 years for patient recruitment.~      Twelve-hundred bleeding adult cardiac surgical patients who require fibrinogen~     supplementation due to acquired hypofibrinogenemia after CPB will be included. Patients will~     be randomized to receive equivalent doses of either fibrinogen concentrate (Octafibrin) or~     cryoprecipitate when the blood bank receives the first order for fibrinogen supplementation~     and deems it to be in accordance with accepted clinical standards. Thereafter, patients will~     be treated according to their assigned group each time fibrinogen supplementation is ordered~     during the treatment period (24 hours after termination of CPB). No other aspects of care~     will be modified.~      The primary efficacy outcome will be the number of Allogeneic blood products (ABP) (red blood~     cells [RBCs], pooled or apheresis platelets, and plasma) administered during the first 24~     hours after termination of CPB. Safety outcomes will be measured for the first 28 days after~     surgery, which is the duration of participation of each patient in the trial. Comparisons~     will be by intention-to-treat (ITT) (primary) and per-protocol (PP) analysis. One interim~     analysis will be conducted after 600 patients have been treated to determine whether the~     study should be terminated for safety reasons, demonstrated non-inferiority or futility~     reasons.~   "
40438|NCT03037411|"~     The REGAL study is a European, prospective, multi-center Post-Market Clinical Follow-up~     (PMCF) trial providing additional data including health economics data to support the use of~     the ELUVIA stent in the treatment of lesions located in the femoropopliteal arteries.~   "
40439|NCT03037398|"~     The objective of this study is to evaluate the performance of novel DBS programming methods~     compared to traditional programming methods.~   "
40440|NCT03037385|"~     This is a Phase 1, open-label, first-in-human study designed to evaluate the safety,~     tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antineoplastic~     activity of BLU-667 administered orally in patients with NSCLC, thyroid cancer and other~     solid tumors.~   "
40441|NCT03037372|"~     This study will determine whether 36 months of daily atorvastatin or rosuvastatin have~     equivalent effects in reduction of immune activation, inflammation and immune aging, when~     given as adjunct therapy among patients receiving antiretroviral therapy in an African cohort~   "
40442|NCT03037359|"~     This is a safety study to evaluate the risk of low blood pressure in subjects with Primary~     Immune Deficiency disorder (PID) treated with Bivigam™ or another commercial product under~     real world conditions. No study medication will be provided to subjects in this study. Study~     physicians will make all treatment decisions according to their usual practice and will~     provide prescriptions for his/her subjects, as appropriate. The only addition is the~     collection and structured documentation of data generated through usual practice.~   "
40443|NCT03037346|"~     The goal of this research study is to learn how well MD Anderson helps patients and their~     families select and prepare an MPOA. Researchers want to find out if social work counseling~     and education help to increase the number of patients who complete MPOA documents. They also~     want to study how counseling and education affects attitudes about medical decision-making,~     and willingness to take part in these kinds of conversations for patients and their family~     members and/or caregivers.~      This is an investigational study. Reviewing your medical record and completing a set of~     surveys at your new patient appointment and again 3 months later is the only part of this~     study that is considered investigational.~      Up to 180 patient and caregiver pairs will take part in this study. All will be enrolled at~     MD Anderson.~   "
40444|NCT03037333|"~     A lot of questions about use of temporary transvenous pacing still remain obscure and there~     is no effective comparison between use of fluoroscopy versus electrocardiogram/echocardiogram~     in patients with bradicardias. The aim of the study is to evaluate how long does it take to~     start the correct cardiac stimulation with transvenous pacing in patients with bradicardias~     comparing use of fluoroscopy versus electrocardiogram/echocardiogram and compare rates of~     complications between two methods.~   "
40445|NCT03037320|"~     Comparison of Coronally advanced flap with semilunar vestibular incision technique for root~     coverage in patients with multiple gingival recession in maxillary teeth.~   "
40446|NCT03037307|"~     The objective of this study will be to compare bite force (BF) measurements over a 12-hour~     period of a currently marketed denture adhesive cream based on carbomer technology (test),~     with a positive control and a negative/no treatment control.~   "
40447|NCT03037294|"~     Rationale: Osteoarthritis (OA) of the knee is a common cause of pain and disability,~     especially in people over the age of 65. In the current health care system both conservative~     (e.g. intra-articular injections with corticosteroids) and surgical (total knee replacement,~     TKR) treatment are applied. Although frequently used, certain effects of these treatments on~     protein metabolism remain unclear. It is well known that maintenance of different tissues is~     determined by a dynamic balance between protein synthesis and breakdown rates, with temporary~     changes in either protein synthesis or breakdown allowing net protein accretion or loss.~     However, intra-articular injections with corticosteroids as a conservative treatment are~     thought to have several negative consequences thereby potentially affecting protein~     metabolism of different musculoskeletal tissues. In addition, though protein supplementation~     has shown to be an effective nutritional strategy in stimulating muscle protein synthesis, it~     remains unclear to what extent other musculoskeletal tissues are able to respond to dietary~     protein supplementation. Therefore, the current study assesses the impact of intra-articular~     corticosteroid injections and preoperative protein supplementation on protein synthesis in~     different musculoskeletal tissues of the knee.~      Objective: To investigate the effect of preoperative protein supplementation and~     corticosteroid injections on Hoffa's fat pad, synovium, tendon, bone, muscle, ligament,~     menisci, and cartilage protein synthesis of the OA knee.~      Study design: Randomized, parallel (three groups) study design. Each of the two intervention~     groups will be compared to the control group separately.~      Study population: 36 adults (45-75 y) with OA of the knee undergoing TKR. Intervention:~     Intra-articular injection of betamethasone (2ml; 4mg/ml) and bupivacaine (8ml; 5mg/ml) or~     daily 40 g of pre-sleep protein two weeks before TKR, or no intervention.~      Main study parameters/endpoints: Primary study parameters include protein synthesis rates and~     enrichments of Hoffa's fat pad, synovium, tendon, bone, muscle, ligament, menisci, and~     cartilage. Secondary parameters include whole-body protein synthesis, breakdown, oxidation,~     and net balance.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: The risks involved in participating in this study are minimal. There are no~     potential effects known for the ingestion of protein. The corticosteroid injection is~     standard care in conservative treatment of osteoarthritis. Risks are small and limited to the~     knee itself, such as cartilage degeneration or joint destruction. Muscle biopsies and tissue~     collection will be performed during the surgical procedure.~   "
40498|NCT03036631|"~     The Ideal Sedation for Stroke Thrombectomy (ISST) registry will answer the key questions~     whether sedation with intubation and paralytics is feasible and whether it delays the time to~     recanalization in comparison with conscious sedation alone. As a pilot registry, it is~     anticipated to enroll 40 acute stroke patients requiring mechanical thrombectomy over 12-18~     months. Following enrollment, data will be collected prospectively from medical records and~     from patients' visits.~   "
40448|NCT03037281|"~     Nociceptin is a protein found in the body, with a number of functions in the central nervous~     system, blood vessels and the gut. There is evidence that it may have a role in controlling~     the immune response to infection, and may act as a link between the brain and immune system.~      In infection, or after surgery, there is an increase in nociceptin, and subjects greater~     elevations of nociceptin have a poorer outcome. There is evidence that cells of the immune~     system may produce nociceptin, although it is not yet known which cells are capable of~     producing it, and what switches on production.~      This study aims to determine~        1. Which cells of the immune system can produce nociceptin~        2. If there is a difference in the ability to produce nociceptin between healthy volunteers~          and patients with severe infections~   "
40449|NCT03037268|"~     1. Establish the quality of fundus images produced by plenoptic ophthalmoscopy using the~          grading system proposed and utilized in the Fundus Photography versus Ophthalmoscopy~          Trials Outcomes in the Emergency Department (FOTO-ED) Study.~        2. Determine diagnostic utility of plenoptic ophthalmoscopy images by comparing masked~          image reviewers' quality measurements and findings to images obtained with a~          commercially available ocular fundus camera and documented exam findings~   "
40450|NCT03037255|"~     This study aims to determine the extent to which pre-existing long-term conditions are~     associated with survival following a heart attack (acute myocardial infarction) using~     observational data from the UK's national heart attack register.~   "
40451|NCT03037242|"~     The results of this study will optimize the care for patients with a meniscus root tear.~     Surgeons will be able to determine if MRR (meniscus root repair) with transtibial pullout~     technique is an effective treatment and will identify potential risk factors for poor~     clinical outcomes. In addition, investigators will determine if MRR is successful in delaying~     the radiographic progression of arthritis in the involved compartment.~   "
40452|NCT03037229|"~     Is the Smartphone ECG (electrocardiogram) an acceptable replacement for a standard ECG in the~     identification of STEMI (ST Elevation Myocardial Infarction).~   "
40453|NCT03037216|"~     The purpose of this study is to find out whether exercise training leads to changes in the~     blood that are produced by exercised muscles and if these changes produce new hormones that~     affect the body's regulation of sugar and body weight.~   "
40454|NCT03037203|"~     This study is a 4-week, multicenter, randomized, double-blind, placebo-controlled, ascending~     dose, 4-period crossover study designed to evaluate the safety, tolerability, efficacy, and~     PK of JZP-110 (75, 150, and 300 mg) in the treatment of excessive sleepiness in adult~     subjects with idiopathic PD.~   "
40455|NCT03037190|"~     The overall aim of this project is to investigate whether a gluten free diet after the onset~     of type 1 diabetes (T1D) can better preserve the remaining beta cell mass and at the same~     time prevent the development of Celiac Disease (CD) in these patients.~      Specific aims~      • To study whether gluten free diet during one year after the onset of diabetes influence the~     appearance and duration of clinical remission in children with Type 1 diabetes.~      New data show that a gluten free diet is beneficial concerning the insulin production after~     the onset of diabetes. The investigators want to investigate if gluten is a triggering~     protein for the destruction of the beta cell function after the onset of diabetes by~     comparing children who have a normal diet compared to children with a gluten free diet during~     one year after the onset of the disease.~        -  To study whether a gluten free diet during one year after the onset of diabetes prevent~          the development of Celiac Disease in these children and the impact of having two~          diseases It is known that it is almost 10 times more common that children with Type 1~          Diabetes (IDDM) develop Celiac Disease (CD) than the general population and that most of~          these children (6-7 %) develop CD after the onset of Diabetes and within 5 years. Based~          on our new data that CD is preventable to some extent the investigators plan to perform~          randomized controlled studies if it is possible to prevent or postpone CD by means after~          the onset of IDDM.~        -  To investigate the impact of gluten free diet on the regulation of autoimmune responses~          The investigators will test the hypothesis that gluten free diet in children with recent~          onset T1D will implement immune regulation and inhibit the activation of potentially~          autoreactive T cells.~   "
40456|NCT03037177|"~     Mediastinal grey zone lymphoma, B cell lymphomas with intermediate features between classical~     Hodgkin lymphoma and primary mediastinal B cell lymphoma, are not well described in the~     literature. Investigators report the clinical characteristics and outcomes of a large~     retrospective series of 99 cases centrally reviewed by a panel of hematopathologists, with a~     consensus established for the diagnosis.~   "
40457|NCT03037164|"~     Stage A: To evaluate the safety and efficacy of the INTERCEPT Blood System for Red Blood~     Cells Pathogen Reduction Treatment (PRT) in comparison to conventional RBCs in adult patients~     who require RBC transfusion support.~      Stage B: To provide early access to the INTERCEPT pathogen reduction system for RBC in~     regions where a substantial proportion of the population has been infected or is at risk of~     infection by the Zika virus (ZIKV), and the risk of asymptomatic infection among qualified~     blood donors is recognized. Besides the reduction of risk of transfusion transmitted ZIKV,~     the intent of the study is also to reduce the risk of transfusion-transmitted infections~     (TTI) in general, including transfusion related sepsis and other emerging or concurrent~     endemic pathogens (e.g. Dengue and Chikungunya), and to reduce the risk of TA-GVHD.~      As part of this treatment use study, additional data will be provided on the safety of~     INTERCEPT-treated RBCs (IBS RBCs) supplied for routine clinical transfusion practice.~   "
40458|NCT03037151|"~     This study will evaluate the safety and efficacy of combination treatment with grazoprevir +~     elbasvir for compensated cirrhotic participants with chronic genotype 1 (GT1) and genotype 6~     (GT6) hepatitis C virus (HCV) infection with or without human immunodeficiency virus (HIV)~     infection.~   "
40459|NCT03037138|"~     Hemodialysis patients frequently complain of postdialysis fatigue and washed-out feeling. The~     aim of this study is to use blood flow rate (BFR) profiling to mitigate postdialysis~     washed-out state.~   "
40566|NCT03035747|"~     Ongoing registration of patients with varicose veins disease treated by means of conventional~     surgery, endovenous thermal ablations, sclerotherapy, non-tumescent non-thermal methods~   "
40567|NCT03035734|"~     Open label, randomized, 4-period crossover study with single doses of BMS-986141 given to~     healthy female subjects of non-childbearing potential and healthy males.~   "
40461|NCT03037112|"~     Antibiotic overuse and misuse contributes to the development of antibiotic resistant~     infections and adverse drug reactions. The majority of all antibiotic prescribing occurs in~     outpatient settings; most of which are for respiratory illnesses. It is estimated that 50% of~     these prescriptions are unnecessary. The most important factor that leads to overprescribing~     is inadequate parent-provider communication. This study will recruit providers and eligible~     parents of children 1-5 years of age. Parents in both arms will receive identical brief~     antibiotic education via tablet computers. Providers will be randomized to the~     parent-provider education or communication skills intervention arm and trained accordingly.~     Parent data will be collected via a tablet computer RedCap survey administered in the exam~     room prior and immediately following the child's visit. Additional data will be garnered from~     the medical record (antibiotic prescribing) and a 2-week follow-up telephone call with~     parents (re-visits and adverse drug reactions).~   "
40462|NCT03037099|"~     The main purpose of this study is to examine the effectiveness of enhanced GI-targeted~     nutrition education on dietary behaviour and intakes among adults with type 2 diabetes.~     Sixty-six eligible participants will be randomized into two equal groups using a pragmatic~     randomized controlled trial design.~   "
40463|NCT03037086|"~     MEDI-APEX is a non-interventional, retrospective, cohort study to characterize PD-L1~     expression and to assess the clinical characteristics and outcomes among NSCLC patients~   "
40464|NCT03037073|"~     For >60 years, succinylcholine is still being administered as a selective relaxant for rapid~     sequence intubation by anesthesiologists in many countries. It has been shown to possess~     unique features such as low cost, fast-acting, short half-life, safe metabolites, and causing~     excellent muscle relaxation for intubation. It has many side effects as well. Postoperative~     myalgia (POM), with an incidence rate of ~41%-92%, is one of the most common side effects of~     this drug and can take several days to cause significant discomfort in patients. However, its~     effect is felt more in the throat, neck, shoulder, and abdominal muscles and is common among~     patients with outpatient surgery. Due to its unknown real context of pathogenesis and in an~     effort to reduce the incidence and severity of succinylcholine-induced myalgia, various~     medications including nondepolarizing muscle relaxants, benzodiazepines, magnesium sulfate,~     opioids, gabapentin, and nonsteroidal anti-inflammatory drugs have been tested, with varying~     degrees of success.~      Duloxetine is an US Food and Drug Administration-approved analgesic used for various pain~     syndromes, including diabetic peripheral neuropathy and fibromyalgia. The underlying~     mechanism for duloxetine against these pain syndromes remains unclear, but it may involve~     three major central nervous system (CNS) targets: (1) serotonin transporter (Ki, 4.6 nM), (2)~     norepinephrine transporter (Ki, 16 nM), and (3) dopamine transporter (Ki, 370 nM). In the~     past, the antidepressant action was often thought to be the primary mechanism for its~     analgesic efficacy. This theory was addressed later by Path Analysis, and the result showed~     that duloxetine affects pain directly rather than indirectly through mood improvement. In~     addition to these multiple CNS targets, duloxetine, like the antidepressant amitriptyline and~     the local anesthetic bupivacaine, blocks voltage-gated Na+ channels. Because neuronal Na+~     channels are present in both CNS and peripheral nervous systems, such a finding expands the~     possible analgesic action and locus of duloxetine.~   "
40465|NCT03037060|"~     There is a need to better understand the mechanisms underlying alcohol use and dependence in~     order to advance the clinical treatment of alcohol dependence. Here, the investigators will~     use Positron Emission Tomography to determine if there is an up-regulation of D3 receptors in~     the brains of subjects with alcohol use disorders. The investigators will also investigate~     the relationship between D3 binding and major phenotypes associated with alcohol use~     disorders, namely: alcohol cue induced craving and motivation to self-administer alcohol in~     the laboratory.~   "
40466|NCT03037047|"~     This parallel, double blind, randomized, controlled, multi-center study will evaluate the~     efficacy and safety of salvianolate injection in elderly patients with unstable angina~     pectoris.~   "
40467|NCT03037034|"~     Endoscopic submucosal tumor resection using biopsy forceps was performed for 11 consecutive~     patients who had clinical indications for lesion removal. Following the injection around a~     submucosal tumor, the adjacent mucosa or submucosa was grasped with the forceps and pulled~     away to form a tent. The tissue was dissected using an electrocoagulating current. In~     brief, the tumor was dissected from the muscularis propria layer and then carefully removed~     using forceps. Demographic data, indication for intervention, safety of the procedure and~     follow‐up will be assessed.~   "
40468|NCT03037021|"~     The overall goal of this proposed project is to 1) increase co-management between sickle cell~     specialists and primary care providers (PCP's); 2) increase the use of hydroxyurea (HU) which~     prevents Vaso-Occlusive Episode (VOE), EDs and subsequent hospitalizations, and death; 3)~     identify and link patients not receiving primary or SCD specialty care to care, and 4) shift~     healthcare use from EDs and hospitalizations to primary and specialty co-management. Many~     persons with SCD experience a poor quality of life, serious medical complications and~     frequent painful events that require treatment from SCD specialty care, primary care and~     emergency department (ED) providers. There are two dominating models of care in the United~     States; neither are ideal. Many people with SCD have all of their healthcare needs addressed~     by sickle cell specialists who do not typically provide primary care and are often~     geographically distant from the patients' home. Other sickle cell patients receive all of~     their care in EDs. Both models are inadequate and result in an alarmingly high number of ED~     visits for many patients. Current care models are neither cost efficient nor promoting~     optimal patient outcomes. To improve outcomes, the investigators will implement a new model~     of care for SCD using nurse care managers, web based-interactive algorithms, and test if~     additional patient provided coaching can improve outcomes.~   "
40469|NCT03037008|"~     Prospective study to evaluate a new technique. Comparison of perineal sonography in men~     before and after radical prostatectomy and in incontinent men after radical prostatectomy~     before and after operative treatment with male sling and comparison with pre- and~     postoperative functional MRI~      Inclusion / Exclusion criteria: Inclusion: male, elder than 18years, planned RALP or history~     of RALP and PPSUI (Post Prostatectomy Stress Urinary Incontinence).~      Exclusion: Patients with history of urinary incontinence before radical prostatectomy.~     Patients with history of radiotherapy in the pelvis. Other diseases involving pelvic floor.~   "
40568|NCT03035721|"~     This study aimed to evaluate the tolerance and safety of a low-protein formula in healthy~     full-term infants by investigating effects on growth and gastrointestinal tolerance and by~     identifying any adverse effects.~   "
40569|NCT03035708|"~     This study is a double-blind, randomized, placebo-controlled, parallel group, two-site study~     designed to assess the effects of varenicline as compared with placebo on responses to in~     vivo alcohol cue exposure in the human laboratory setting.~   "
40470|NCT03036995|"~     Vitiligo is a depigmentation disorder affecting 0.5 to 2% of the general population. It is an~     acquired pigmentary disorder of the skin and mucous membranes that is characterized by~     circumscribed, depigmented macules and patches. Apremilast is a phosphosdiesterase 4 (PDE4)~     inhibitor that showed efficacy and very good tolerance in rheumatoid arthritis and psoriasis.~     Apremilast induces a potent activation of the cyclic AMP (cAMP) pathway leading to~     anti-inflammatory effect by decreasing the response of Th1 and Th17 lymphocytes.~     Interestingly, the cAMP pathway is also well demonstrated to be the main pathway for~     promoting melanogenesis and for inducing the differentiation and the proliferation of~     melanocytes. The principal aims is to compare, after 24 weeks of treatment, the efficacy of~     Apremilast at the label dosage in combination therapy with narrow band UVB versus placebo~     therapy with narrow band UVB for repigmentation in patients with non-segmental vitiligo.~     Patients with non-segmental vitiligo with BSA > 10% and patient with Vitiligo stable or~     slowly progressive for 3 months , seeking for treatment in the Department of Dermatology,~     University Hospital of Nice, France will be recruited into the study. The Patients are seen~     in consultation by the investigator, selection criteria are checked. All patients will~     receive full body narrow UVB treatment, twice weekly sessions of narrow UVB for 24 weeks.~      From W24 to W48~        -  All responders* will receive narrow UVB treatment according the French clinical use~          i.e.twice weekly sessions of narrowband UVB for 24 weeks.~        -  All responders* will be randomized to receive either apremilast** 30mg BID or placebo.~             -  Response is defined as an increase of at least 30 % in the VASI score at W24~               compare to baseline **Responders initially randomized in the placebo arm will~               benefit of the titration At week 24, the non responders patients will stop the~               treatment and the study after the 4 weeks observationnal follow-up (W28).~      Observational Follow-up Phase - W48 to W52 Four-week Observational Follow-up Phase for all~     subjects who complete the study (responders and non responders) or discontinue the study~     early.~   "
40471|NCT03036982|"~     This study will assess whether adaption of the Asthma Control Test (ACT) and childhood Asthma~     Control Test (cACT) for mobile devices improves rate of completion and improves control of~     asthma in children and adolescents~   "
40472|NCT03036969|"~     EPICS-8: Reasons for Emergency Department utilization by patients with non-urgent conditions:~      Emergency Departments (EDs) are an important interface between primary and secondary health~     care sectors in Germany. The number of outpatient visits in the ED´s is still increasing. The~     reasons for ED utilization by patients with non-urgent conditions are nearly unknown in~     Germany and will be investigated in this project.~   "
40473|NCT03036956|"~     The Precious study is likely to help determine the frequency (percentage) of subclinical~     hypothyroidism among pregnant women in Pakistan It will also help to determine the risk~     factors for developing subclinical hypothyroidism during pregnancy~   "
40474|NCT03036943|"~     The purpose of this study is to find out what a new amino acid-based PET agent, fluciclovine~     (18F), can tell us about breast cancer biology (how it grows and develops), and quantify the~     differences in fluciclovine (18F) uptake between breast cancer subtypes. This will inform~     further work to investigate its use in breast cancer management.~   "
40475|NCT03036930|"~     This phase II trial studies how well a nonavalent human papillomavirus vaccine works in~     preventing human papillomavirus-related cancer in adult women prior to living donor kidney~     transplantation. Vaccines made from peptides of human papillomavirus may help the body build~     an effective immune response to kill tumor cells. Giving booster vaccinations may make a~     stronger immune response and prevent or delay the recurrence of cancer.~   "
40476|NCT03036917|"~     This study aims to investigate the cognitive function of patients in the opioid reduction~     programme at the multidisciplinary pain centre at Zealand University Hospital Køge.~      The patients will be tested before, halfway through, and after the programme.~   "
40477|NCT03036904|"~     This is a phase I, open label, single-arm, multi-center, dose-finding study of venetoclax in~     combination with DA-EPOCH-R in patients with aggressive B-Cell Lymphomas.~   "
40478|NCT03036891|"~     The objective of this study is to evaluate the effects of naloxegol (a peripheral mu-opioid~     receptor antagonist [PAMORA]) in opioid-related gastroparesis on 1) symptoms of~     gastroparesis; 2) gastric emptying; and 3) pain control. The endpoints will be gastroparesis~     symptoms (PAGI-SYM), gastric emptying (GEBT), and pain control (McGill Pain Inventory). The~     hypothesis to be tested is that naloxegol improves symptoms of gastroparesis in patients who~     are taking opioids as well as improves their gastric emptying while maintaining control of~     patient's pain. This study will entail an initial double-blind, randomized,~     placebo-controlled, 4-week treatment period of naloxegol vs placebo in patients with~     opioid-related gastroparesis followed by a 4-week open label period to demonstrate the~     improvement in symptoms and gastric emptying with naloxegol.~   "
40479|NCT03036878|"~     To evaluate the use of ReNu™ allograft for the augmentation of marrow stimulation for~     osteochondral lesions~   "
40480|NCT03036865|"~     Study BOS161721-01 is a randomized, single center, double-blind, placebo-controlled trial~     conducted to study the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of single~     ascending intravenous (IV) and subcutaneous (SC) doses of BOS161721 or placebo in healthy~     adult male and female participants.~   "
40481|NCT03036852|"~     The primary objectives of this study are to evaluate safety, efficacy and tolerability of~     treatment with sofosbuvir (Sovaldi®)/velpatasvir (Epclusa®; SOF/VEL) for 12 weeks in adults~     with chronic hepatitis C virus (HCV) infection who are on dialysis for End Stage Renal~     Disease (ESRD).~   "
40482|NCT03036839|"~     The primary objectives of this study are to evaluate the safety, efficacy and tolerability of~     treatment with ledipasvir/sofosbuvir (LDV/SOF) in adults with chronic hepatitis C virus (HCV)~     infection who are on dialysis for End Stage Renal Disease (ESRD).~   "
40483|NCT03036826|"~     Adequate dosing of antiinfective therapy in critically ill patients with impaired or lost~     renal function and continuous renal replacement therapy is nearly impossible without~     measuring the drug concentration in blood samples. In many hospitals that is not an option.~     The investigators aim to show, that computer based calculation can avoid over- or~     under-dosing.~   "
40484|NCT03036813|"~     A Phase 3, Double-blind, Randomized, Placebo-controlled, Multicenter Study of GBT440~     Administered Orally to Patients With Sickle Cell Disease~   "
40485|NCT03036800|"~     A two year, parallel, two group, open-label, real-world randomised controlled trial (RCT)~     design for subjects with severe and complex obesity who are referred to a Tier 3 or~     equivalent specialist weight management/obesity service. Participants will be randomised to~     receive 1) standard care (obesity-specialist care), or 2) targeted prescribing pathway~     (obesity-specialist care plus targeted use of Liraglutide 3.0mg [LIRA 3mg] with pre-specified~     stopping rules for the medication). The aim of the study is to compare the effectiveness,~     budget impact, and cost-effectiveness between the two groups in a real-world setting among~     otherwise largely unselected patients.~   "
40486|NCT03036787|"~     Infant born preterm have an increased risk of adverse long-term developmental outcomes.The~     risk associated with preterm birth increase as gestational age decreases, and vulnerability~     remains in extremely- very preterm (<32 weeks) and moderate- late preterm (>32 weeks). There~     are many studies in the literature showed that the prevalence of developmental delay~     increases with premature birth. However, there is no study in the literature investigates~     long term follow up motor and cognitive development in subgroups of preterm infants . Hence~     the aim of this study is to evaluate the differences in motor and cognitive development in~     moderate-late (>32 weeks) and extremely-very preterm infants.~   "
40487|NCT03036774|"~     The main objective is to compare the frequency of a  full stomach  in diabetic patients~     compared with a control population, all the patients having followed the instructions of~     preoperative fast.~   "
40488|NCT03036761|"~     The aim of the study is to show that auriculotherapy decreases the number of days with~     painful episodes of migraine and headache after 3 months of treatment~   "
40489|NCT03036748|"~     The aim of this study is to determine if amiloride, a diuretic drug, is capable of increasing~     renal salt excretion, lowering blood pressure and inhibiting uPA in kidney transplant~     recipients with proteinuria compared to normoalbuminuric transplant patients.~   "
40490|NCT03036735|"~     The study is designed to evaluate if addition of the steroid to the spacer / stent will~     improve healing after endoscopic sinus surgery (ESS) compared to spacer without drug.~   "
40491|NCT03036722|"~     This proposed randomized double blinded, placebo-controlled, parallel trial; with two arms,~     in females aged 50-70 years, volunteers will be postmenopausal with a BMI between 25-35~     kg/m2. This study aims to determine the benefits of phytoestrogen-rich flaxseeds on~     decreasing bone turnover in postmenopausal women aged over 50 years.~   "
40492|NCT03036709|"~     This is a placebo-controlled clinical trial of VRC01 administration and analytic treatment~     interruption (ATI) in adults who began antiretroviral therapy (ART) during early acute HIV~     infection (Fiebig stage I to III). Eligible volunteers will be randomized in a 3:1 ratio to~     either VRC01 or placebo, with randomization stratified by Fiebig stage. Volunteers who are~     receiving ART with a non-nucleoside reverse transcriptase inhibitor (NNRTI) will undergo 4~     weeks of protease inhibitor (PI) substitution for their NNRTI prior to randomization. ATI~     will begin the day of the first dose of either VRC01 or placebo. Participants will be~     monitored closely for HIV viremia and other pre-defined criteria for ART resumption.~     Administration of the study agent (VRC01) every three weeks will be discontinued after 24~     weeks or if ART is resumed, whichever occurs first. Volunteers who remain virally suppressed~     without laboratory or clinical indication for ART resumption at 24 weeks will continue~     intensive monitoring for ART resumption criteria for an additional 24 weeks, during which~     time no VRC01 or placebo will be administered.~   "
40493|NCT03036696|"~     Interview pregnant and breastfeeding mothers in the Gainesville, FL area to optimize;~     clinical study recruitment and retention, patient-centered outcomes, and stool collection~     procedures.~   "
40494|NCT03036683|"~     This study investigates the effect of upregulating prefrontal cortex activity on risk-taking,~     and antisocial and aggressive behavior in violent offenders. In the double-blind, randomized~     controlled trial, using a within-subject crossover design, each participant will undergo~     anodal transcranial direct current stimulation of the right dorsolateral prefrontal cortex~     and sham stimulation. After each stimulation session, neural activity and behavioral~     responses to tasks assessing risk-taking and aggressive behavior will be recorded. The effect~     of tDCS on violent offenders will also be assessed in comparison to age and gender-matched~     healthy controls.~   "
40495|NCT03036670|"~     EGPA (Eosinophilic Granulomatosis with Polyangiitis, previously Churg-Strauss syndrome) is a~     rare vasculitis, characterised by asthma, rhinosinusitis and eosinophilia. There has~     previously been confusion around diagnostic criteria, with multiple sets of classification~     criteria being used inappropriately for diagnosis. The ERS formed a taskforce to produce~     specific diagnostic criteria, and these divided the Churg-Strauss Syndrome cohort into two~     groups - vasculitic EGPA and tissular Hypereosinophilic Asthma with Systemic Manifestations~     (HASM). It is not known if the groups separated by the diagnostic criteria are also separated~     in clinical symptomatology, or if their disease course varies, and this could have~     significant impact on management and further research.~   "
40496|NCT03036657|"~     Thus study aims to characterize the local, nerve-specific effects of acupuncture on the~     median and ulnar nerves in the forearm, using nerve conduction studies and quantitative~     sensory testing. All participant will have carpal tunnel syndrome and the affected median~     nerve will be compared to the healthy ulnar nerve. Additionally, we aim to compare the local,~     nerve-specific effect of manual acupuncture to that of low-frequency electroacupuncture and~     of high-frequency electroacupuncture.~   "
40497|NCT03036644|"~     Background: Electronic cigarettes (e-cigarettes) are battery-powered devices heating a liquid~     (e-liquid) composed of propylene glycol and/or vegetable glycerin, and most commonly,~     nicotine to form an aerosol (vapor) that is inhaled (i.e. vaped). Scarce and conflicting~     data are available regarding the cardiovascular toxicity of e-cigarettes. We wish to~     determine the acute effects of propylene glycol/vegetable glycerin and nicotine vaporization~     at high temperature in comparison to tobacco cigarette smoking on several advanced~     cardiovascular parameters in healthy chronic e-cigarettes users and tobacco smokers.~     Furthermore, a large range of plasma, urine and respiratory oxidative stress markers will be~     quantified. By this way, we aim to demonstrate that e-cigarettes-induced systemic oxidative~     stress could be linked to cardiovascular toxicity. To the best of our knowledge, this is the~     first project that evaluates the effects of e-cigarettes vaping in comparison to tobacco~     cigarette smoking on the cardiovascular system in relation to vaporization temperature,~     nicotine delivery and oxidative stress.~      Aims of the study: This study tests the following hypotheses: 1) acute high temperature~     vaporization of propylene glycol and vegetable glycerin has no deleterious effects on~     cardiovascular parameters in comparison to tobacco smoking; 2) Tobacco smoking rises plasma~     and urine oxidative stress biomarkers. On the contrary, acute and chronic e-cigarettes vaping~     don't rise these biomarkers. At a cellular level, plasma of smokers but not vapers increases~     superoxide anion production.~   "
40570|NCT03035695|"~     The aim of this study was to evaluate the efficacy and safety to use external haemostatic~     between Axiostat® (Chitosan haemostatic dressing) and conventional cotton gauze dressing as a~     pre hospital acute hemorrhagic control in trauma in ambulance settings.~   "
40499|NCT03036618|"~     Quinoa is possible alternative to wheat, corn and rice due to its high nutritional value and~     possible properties against cardiovascular diseases and for improving gut health. There are~     some animal studies to suggest that some important class of compounds like fibre,~     antioxidants and protein, found naturally in quinoa, have beneficial effects against markers~     of cardiovascular diseases. However, the effects of quinoa on humans has rarely been~     investigated. This study will investigate the effects of daily consumption of quinoa for four~     weeks on markers of cardiovascular risk, including blood cholesterol and resting blood~     pressure, and on gut health in a randomised cross-over study design.~   "
40500|NCT03036605|"~     Nasal packing is frequently applied after nasal surgery. Nasal packing reduces epistaxis,~     prevents septal hematoma and stabilizes nasal septum. Nasal mucosa is quite sensitive to~     pain, therefore the most common problems after surgery are postoperative pain and anxiety~     during removal of the nasal packing. Lots of methods have been tried to control this pain~     (non-steroidal anti-inflammatory drugs, nerve blockade with long-acting local anesthetics,~     local anesthetics infiltration into nasal packing).~      Glucocorticoids have been used as an adjuvant in the management of acute postoperative pain.~     Perineural dexamethasone as an adjuvant for the single-injection nerve block can prolong~     analgesia and reduce opioid-requiring after surgery. Furthermore dexamethasone reduces~     postoperative nausea and vomiting incidance.~   "
40501|NCT03036592|"~     The purpose of this investigation is to assess the role of melatonin receptor 1B (MTNR1B)~     single nucleotide polymorphism (SNP)*food timing interaction on glucose control in the~     deleterious effect in a vulnerable population with regular exposure to concurrent high~     melatonin and food intake as late night eaters (those having dinner within 2.5 h before their~     usual bed time). With the results from this study, we expect to advance our understanding of~     the role of endogenous melatonin on glucose metabolism in late night eaters and carriers of~     the MTNR1B risk allele, with potential implications on the guidelines to mitigate risk of~     type 2 diabetes in late night eaters and carriers of the MTNR1B risk allele.~   "
40502|NCT03036579|"~     This investigation will be a clinical trial to study the performance of a newly developed~     high strength ceramic material for crowns. The ceramic has been approved by the FDA for~     patient treatment. A computer technique will be used to fabricate the crowns in a single~     appointment without the need for a temporary crown or second appointment. Two adhesive resin~     cement techniques will be used to hold the crown to the tooth and they will be evaluated for~     creating sensitivity to the tooth. The purpose of the study is to measure how well the high~     strength crowns function over an extended period of time.~   "
40503|NCT03036566|"~     This investigation will be a clinical trial to study the performance of a high strength~     ceramic material for bridges to replace missing teeth. The ceramic material has been approved~     by the FDA for patient treatment. A computer technique will be used to make the bridges. The~     bridges will be cemented using an adhesive resin cement (MultiLink Automix/Ivoclar). The~     bridges are planned be evaluated for clinical performance at 6 months, 1 year, 2 years, 3~     years, and if funding permits, 4 years, and 5 years. The purpose of the study is to measure~     how well the high strength bridges function over an extended period of time.~   "
40504|NCT03036553|"~     Chronic musculoskeletal pain (CMP) is highly prevalent, disabling, and with high~     socio-economic costs, with many negative effects on quality of life. CMP affects the ability~     to perform work, social, recreational and domestic tasks, changing the mood and concentration~     of this population. Despite the worldwide prevalence and socioeconomic burden of CMP, a clear~     understanding of its etiology and pathogenesis remains elusive.~      Aims:~      (i) to analyze the possible level of association between pain-related fear, fear of movement,~     self-efficacy, and pain acceptance with pain intensity and disability at the start of the~     study and prospectively evaluate its predictive function; (ii) to evaluate the possible~     mediating role of fear of movement and self-efficacy in the relationship between~     pain-disability in patients with CMP.~   "
40505|NCT03036540|"~     The patients admitted in hospital who had midline catheter inserted in upper limb are~     followed-up for the presence of complications related to catheter introductions. The symptoms~     and signs of upper limb thrombosis are recorded. The diagnosis is confirmed by sonography~     examination. In the selected group of asymptomatic patients sonography examination is done 8~     to 10 days after cathether insertion in order to detect the incidence of the asymptomatic~     thrombosis~   "
40506|NCT03036527|"~     Bladder and sexual dysfunction consistently ranks as one of the top disorders affecting~     quality of life after spinal cord injury. The insights of how activity-based training affects~     bladder function may prove to be useful to other patient populations with bladder and sexual~     dysfunction such as multiple sclerosis, Parkinson's, and stroke, as well as stimulate~     investigations of training's effects within other systems such as bowel dysfunction.~     Locomotor training could help promote functional recovery and any insights gained from these~     studies will enhance further investigation of the effect of bladder functioning after spinal~     cord injury. In addition, as suggested by a study of one of our initial participants, a~     reduction in the use and/or dosage of medication to enhance sexual function is a possible~     outcome, medications which carry risks and side effects.~   "
40507|NCT03036514|"~     In this study, numeric rating scale (NRS) and side effects are measured after usage of a~     sublingual sufentanil tablet system (SSTS) in comparison to intravenous patient controlled~     analgesia (PCIA).~   "
40508|NCT03036501|"~     This is an open-label, non-randomized study investigating the excretion balance, PK and~     metabolism of a single oral dose of [14C]-labeled RO7034067 in healthy male participants.~     This study will assess the characterize mass balance, routes and rates of elimination of~     [14C]-labeled RO7034067, using conventional analytical methods and assess the~     pharmacokinetics of total drug related [14C]-radioactivity, RO7034067 and its metabolite(s).~   "
40571|NCT03035682|"~     The purpose of this study is to determine the impact a mobile health application has on~     adherence to a physical therapy home exercise program and its effect on functional outcomes.~   "
40572|NCT03035669|"~     The present study will investigate the effects of a mindfulness training on emotion~     regulation and social cognition, using several psychological, behavioral, psychophysiological~     and neuroimaging methods.~   "
42159|NCT03014895|"~     The study (E3112/CP1) is a single-center, randomized, double-blind, placebo-controlled,~     single intravenous ascending dose study conducted in Japanese healthy adult males to evaluate~     the pharmacokinetics (PK), safety, and immunogenicity of E3112 following a single intravenous~     dose of E3112.~   "
40509|NCT03036488|"~     The purpose of this study is to evaluate the efficacy and safety of pembrolizumab (MK-3475)~     plus chemotherapy vs placebo plus chemotherapy as neoadjuvant therapy and pembrolizumab vs~     placebo as adjuvant therapy in participants who have triple negative breast cancer (TNBC).~      After a screening phase of approximately 28 days, each participant will receive neoadjuvant~     study treatment (Pembrolizumab + Chemotherapy OR Placebo + Chemotherapy) based on the~     randomization schedule for approximately 24 weeks (8 cycles). Each participant will then~     undergo definitive surgery 3-6 weeks after conclusion of the last cycle of the neoadjuvant~     study treatment. After definitive surgery, each participant will receive adjuvant study~     treatment (Pembrolizumab OR Placebo) for approximately 27 weeks (9 cycles). Following~     adjuvant study treatment, each participant will be monitored for safety, survival and disease~     recurrence.~      The primary study hypothesis is that pembrolizumab is superior to placebo, in combination~     with chemotherapy, as measured by the rate of Pathological Complete Response (pCR) and/or~     Event-free Survival (EFS), in participants with locally advanced TNBC.~   "
40510|NCT03036475|"~     The aim of this study is to evaluate a new method for the localization of breast cancer~     sentinel lymph node using Sienna+® and Sentimag® detection in comparison to our standard~     techniques with radio-isotopes.~   "
40511|NCT03036462|"~     The purpose of this study is to determine whether intravenous iron supplementation using~     ferric carboxymaltosis (FCM) reduces hospitalisation and mortality in patients with iron~     deficiency and heart failure.~   "
40512|NCT03036449|"~     The purpose of this study is to determine whether an educational program for caregivers~     associated with convenient tools is effective to reduce medication preparation and~     administration errors in the Neonatal Intensive Care Units (NICU).~   "
40513|NCT03036436|"~     Participants will take part in a 12 week intervention, with at least one follow up at 24 +/-~     2 weeks. Each participant will be provided with support, motivation and professional guidance~     about improving physical activity (PA) levels and will be given a commercially available PA~     tracker. The PA tracker will also include a smartphone or web-based application, where~     participants can upload their exercise performed each day, and keep up to date with their~     goals using their smartphone or by logging on to their computer. The aim of the study is to~     find out how useful and effective technology with support from a healthcare professional is~     in helping cancer survivors to become more physically active.~      This study will measure objective PA levels of the participants at the start of the study and~     at the end. The acceptability of using this intervention to promote PA in cancer survivors~     will also be investigated.~   "
40514|NCT03036423|"~     The purpose of this study is to test whether certain brain training activities can promote~     cognitive, emotional, and physical health in caregivers of a spouse with dementia. Numerous~     studies show that family dementia caregiving can be stressful, and can increase mental and~     physical health risks. This study aims to understand how to reduce those risks.~   "
40515|NCT03036410|"~     Communication on telephone is challenging for people with hearing loss. For hearing aid~     users, for instance, the inventions for improving speech intelligibility on the phone range~     from an integrated tele coil and individual hearing programs to specially designed phone~     devices. No formal studies involving these devices have been carried out with CI users.~      Thus, this comparative study includes hearing aid as well as CI and bimodal users to evaluate~     different hearing solutions for communication on telephone in terms of intelligibility and~     ease of use.~   "
40516|NCT03036397|"~     Background:~      Arginine vasopressin (AVP) is a hormone made in the body. It can make negative feelings~     stronger. The way AVP is regulated may be abnormal in people who have mood and anxiety~     disorders. SRX246 is a new drug that can block a receptor for AVP on brain cells. Researchers~     want to study how this drug affects the way people respond to threat and anxiety.~      Objectives:~      To see if the new drug SRX246 affects how people respond to the threat of an unpleasant~     shock.~      Eligibility:~      Healthy adults ages 21-50~      Design:~      Participants will be screened in another protocol.~      Participants will have 4 visits over 4 weeks.~      At visit 1, participants will have small electrodes taped to their arm to give shocks.~     Electrodes on the arm, chest, and face will measure sweat, heart rate, and blinking.~     Participants will hear loud noises and get test shocks for about 15 minutes.~      At the other 3 visits, participants will have some or all of these tests:~        -  Blood and urine tests~        -  Heart tests~        -  Suicide screen~      At each visit, participants will answer questions about their mood and anxiety. They will~     identify emotions in pictures. They will have shock testing for 40 minutes: they will hear~     loud sounds through headphones and get shocks.~      Participants will take the study pill 2 times a day for a week after visit 1 and a week after~     visit 3. One week it will be SRX246. The other week it will be a placebo.~      Participants may be contacted daily to remind them to take the medicine.~      Participants will have either a follow-up visit or follow-up phone call.~   "
40517|NCT03036384|"~     Hyperbaric bupivacaine 0.5% associated with opioids is the local anesthetic the most commonly~     used for spinal injection in cesarean section. Nevertheless, its use often results in a long~     duration of motor nerve block and a haemodynamical instability. Recently developped, the~     Prilocaine, with its new 2% hyperbaric formulation, seems to offer a good alternative for~     hyperbaric bupivicaine. A first study has determined the ED95 of hyperbaric prilocaine 2% for~     intrathecal anesthesia in scheduled cesarean delivery. As opioid adjuvants potentiate the~     effect of the local anesthetics while decreasing their dose-related side effects, the aim of~     this study is to determine the ED95 of hyperbaric prilocain 2% with sufentanyl for scheduled~     cesarean delivery under spinal anesthesia,by using the Continual Reassessment Method (CRM)~   "
40518|NCT03036371|"~     The goal of this pilot study is to test the procedural aspects of the behavioral tests and~     the exercise components of the study. This includes establishing typical scores for anxiety~     patients in these behavioral tests, and administering and coaching anxiety patients in an~     at-home exercise regimen. This pilot study will produce the information necessary to design a~     larger future study including both patients and healthy control participants.~   "
40519|NCT03036358|"~     The effect of teledermatology on length of hospital admission, length of stay, 30 day~     readmission rate, and antibiotic use in patients presenting with cellulitis vs~     pseudocellulitis in an academic emergency department setting.~   "
40520|NCT03036345|"~     Surgery to the shoulder may be performed with patients seated upright in a position known as~     the Beach Chair Position (BCP). This position has certain advantages compared to~     alternative surgical positions (e.g. side lying) in some situations. However, it has been~     found that surgery in the BCP can temporarily decrease the amount of oxygen in the brain as a~     result of the combined effects of gravity and anaesthesia. This can result in complications~     following surgery such as some memory loss and confusion. Rarely, more serious complications~     have been reported in the past including death and stroke.~      Due to these reported complications the use of cerebral oximetry during shoulder surgery in~     the BCP has become more common. Before and during surgery, a monitor placed on the patients~     forehead measures the amount of oxygen present in the brain to help control this to an~     acceptable level. A number of monitors are now commercially available. Two monitors are~     commonly discussed in the literature; the INVOS™ 5100 and the FORE-SIGHT® machines. However,~     the actual relationship between the supply of oxygen to the brain during surgery and the~     chance of later developing problems with memory and thinking (known as post operative~     cognitive decline - POCD) is not clear. It is also not known if one monitor is more accurate~     than another at predicting these complications.~      Therefore, the main aim of this study is to examine the relationship between cerebral oxygen~     levels during shoulder surgery and the incidence of POCD (i.e. problems with memory and~     thinking). A second aim is to compare the INVOS™ 5100 and FORE-SIGHT® monitors ability to~     measure cerebral oxygen and cerebral desaturation events (CDEs) as well as the importance of~     other key clinical variables (e.g. blood pressure, nausea, body fat etc).~   "
40521|NCT03036332|"~     The present study aimed to determine the effects of 16 weeks of aerobic interval training on~     quality of life and a set of clinical biomarkers.~   "
40522|NCT03036319|"~     As individuals grow older, a number of factors can reduce our cognitive (or thinking)~     abilities such as normal aging, neurodegenerative diseases, and cardiovascular disease.~     This study will evaluate whether cognitive rehabilitation and transcranial electrical~     stimulation (TES) can improve cognitive abilities. Cognitive rehabilitation refers to methods~     that are used to improve tasks people have trouble doing in everyday life. Transcranial~     electrical stimulation uses small amounts of electricity to try to alter brain functioning.~     These approaches may help improve cognitive abilities like attention, learning, memory,~     finding words, and problem solving as well as everyday functioning. The goal of this study is~     to identify how to best use these methods, either alone or in combination.~   "
40523|NCT03036306|"~     The purpose of this study is to assess the safety and local tolerability of two different~     concentrations of of SCX-001 cream, as compared to placebo, when topically applied twice a~     day for 21 days to artificially induced dermal wounds in healthy volunteers. In addition, the~     absorption and elimination of profiles of this topically applied product will be determined~     through pharmacokinetic sampling. Assessments for effect of SCX-001 vs. placebo will be done~     but are considered exploratory.~   "
40524|NCT03036293|"~     The purposes of this study are:~        -  To further examine the efficacy and safety of Tenoten® in the treatment of anxiety in~          patients with somatoform, stress-related and other neurotic disorders.~        -  To compare the efficacy of two dosing regimens of Tenoten® (4 tablets daily vs.8 tablets~          daily, both for 12 weeks) in the treatment of anxiety in patients with somatoform,~          stress-related and other neurotic disorders.~   "
40525|NCT03036280|"~     The name of this trial is MissionAD2. This 24-month treatment, multicenter, double-blind,~     placebo-controlled, parallel group, Phase 3 study in participants with Early Alzheimer's~     Disease (EAD) including mild cognitive impairment (MCI) due to AD/Prodromal AD and the early~     stages of mild AD will be conducted to evaluate the efficacy and safety of elenbecestat~     (proposed international nonproprietary name [pINN]) (E2609).~   "
40526|NCT03036267|"~     Asthma rates are high and asthma control is greatly reduced in Black, Medicaid-insured~     adults, due in part to their poor adherence to inhaled corticosteroids (ICS), which in turn~     may be due to erroneous health beliefs about asthma and negative beliefs regarding ICS. A~     brief shared decision-making intervention for use by primary care providers in Federally~     Qualified Health Centers (FQHCs) has the potential to be a novel avenue to greatly improve~     asthma control in this high-risk patient group.~   "
40527|NCT03036254|"~     An urgent need exists to identify effective interventions to arrest or reverse dementia and~     cognitive loss at its earliest stages. The proposed pilot randomized clinical trial will~     investigate the short and long-term effects of hyperbaric oxygen therapy on cognitive~     functioning, cerebral blood flow, and glucose uptake in diabetic elderly with mild cognitive~     impairment. and provide the basis for a large-scale multi-center study of hyperbaric oxygen~     therapy effects on cognition in diabetes. The potential to preserve, or even enhance,~     cognition in elderly at high risk of cognitive decline and dementia has major implications~     for the affected individuals and their support systems that bear the social and financial~     burdens of long-term caregiving.~   "
40528|NCT03036241|"~     The purpose of this study is to determine whether the use of drug-eluting balloons is~     effective in the treatment of (re)stenosis in dialysis fistulae.~   "
40529|NCT03036228|"~     The primary objective of this study is to determine safety and tolerability of Karonudib for~     the treatment of cancer.~      Secondary objectives are to determine a recommended RP2D and schedule for further development~     of Karonudib, to determine the pharmacokinetics of Karonudib, to look for evidence of~     treatment efficacy. Overall survival will also be recorded.~   "
40530|NCT03036215|"~     The purpose of this pilot project is to determine the feasibility and acceptability of~     proposed methods for a subsequent clinical trial of a tailored self-management program (PACT)~     designed to decrease pain in participants with temporomandibular disorders (TMD). The PACT~     program is a personalized program of exercise and behavioral changes implemented through a~     web-based program supported by a health coach. For this feasibility and acceptability study,~     80 adults with TMD pain will be randomized either to the PACT program or to traditional~     self-care.~   "
40531|NCT03036202|"~     To determine the pharmacokinetics of epinephrine during cardiac arrest.~   "
40532|NCT03036189|"~     This is a group randomized trial of an intervention to improve chronic illness~     self-management.~   "
42243|NCT03013803|"~     Required for Advisory Committee for Borderline Substances (ACBS) approval. Aim of this study~     is to access the palatability, compliance and GI-tolerance of Nutricomp® Drink Plus Fibre to~     show that it is acceptable for patients in the United Kingdom.~   "
40533|NCT03036176|"~     Children with severe acute malnutrition (SAM) are at serious risks that compromise their~     growth and development. Studies have shown the benefits of psychosocial intervention in~     mitigating the negative consequences of SAM. However, such intervention studies have targeted~     the critical period in child development and thus focused on children under three years of~     age. Dietary rehabilitation is usually included as part of the intervention package.~     Moreover, these young children in such studies customarily obtain more care than older ones~     and have access to breast milk, more frequent interaction with mother and other caregivers in~     the family. Therefore, effects of psychosocial interventions targeting such age groups may be~     different for older children. Much is not known if children older than three years of benefit~     from similar interventions, and if family-based psychomotor/psychosocial intervention can~     benefit SAM children in low income contexts such as Ethiopia where access to balanced diet~     remains hardly possible. In Ethiopia, one of the poorest countries in the world, many~     children are admitted to hospital for treatment due to SAM. The nutritional rehabilitation~     unit at hospitals provide dietary treatment to the SAM children who are also treated for~     related illnesses and complications. Once discharged from hospital, however, the SAM children~     return to the same poor home environments with inadequate care and unbalanced diets. The main~     objective of this study was to evaluate the effect of play-based family-centered~     psychomotor/psychosocial stimulation on linear growth, nutritional status and developmental~     outcomes of under-six SAM children in the Jimma Zone, south west Ethiopia. This was done by~     randomly assigning the SAM children admitted to Jimma University's Specialized Referral~     Teaching Hospital into control and intervention groups. Both groups were receiving the~     routine medical and dietary treatment services. The intervention group additionally received~     play-based psychomotor/psychosocial stimulation. Caregivers, supported by periodic visits~     made to their homes, continued the simulation. Measurements were taken after six months of~     home follow-up. It was hypothesized that the intervention would significantly improve some of~     the developmental skills of these children, and that the effect may be age-dependent.~   "
40534|NCT03036163|"~     Open-label prospective non-comparative safety, tolerability and pharmacokinetics ascending~     dose randomized cohort study of PBTZ169 (capsules 40 mg) in fasted healthy volunteers after~     single and multiple oral administration~   "
40535|NCT03036150|"~     The purpose of this study is to evaluate the effect of dapagliflozin on renal outcomes and~     cardiovascular mortality in patients with chronic kidney disease~   "
40536|NCT03036137|"~     Relating the electroencephalogram findings of patients with tinnitus before and after a~     therapeutic modality is still scarce in the literature, especially with neuromodulatory~     methods, more specifically with Transcranial Direct Current Stimulation - tDCS. This study is~     a double blind, sham-controlled clinical trial aiming investigate the impact of tDCS on~     patterns of brain electrical activity in patients with chronic tinnitus. 36 volunteers with~     tinnitus will be allocated randomly in 2 groups: the first (n = 18) will receive anodic tDCS~     in the temporoparietal left area and cathode in the right dorsolateral prefrontal cortex and~     the second group (n = 18) correspond to the sham group. In addition, healthy individuals (n =~     18) will be recruited for comparative purposes of brain electrical activity with and without~     tinnitus, totaling 54 participants. Patients with tinnitus will receive transcranial direct~     current stimulation for 20 minutes for 5 consecutive days (1 week) and will be assessed~     before and after intervention by electroencephalogram, Acuphenometry, Visual Analogue Scale -~     VAS and questionnaire Tinnitus Handicap Inventory- THI. Follow-up of volunteers will also be~     performed after 1 month of the end of treatment with tDCS.~   "
40537|NCT03036124|"~     The purpose of this study is to evaluate the effect of dapagliflozin on the incidence of~     worsening heart failure or cardiovascular death in patients with chronic heart failure with~     reduced ejection fraction.~   "
40538|NCT03036111|"~     Trimebutine acts through smooth muscle relaxation. It is presumed that the topical~     application of trimebutine after hemorrhoidectomy may help relieve pain after the procedure~     by relaxing the internal anal sphincter spasm.~   "
40539|NCT03036098|"~     The purpose of this study is to determine whether an investigational immunotherapy nivolumab~     in combination with ipilimumab or in combination with standard of care chemotherapy is more~     effective than standard of care chemotherapy alone in treating patients with previously~     untreated inoperable or metastatic urothelial cancer.~   "
40540|NCT03036085|"~     The aims of the study are to compare the effectiveness and postoperative outcomes of~     liposomal bupivacaine vs plain bupivacaine following video-assisted thoracoscopic surgery.~     The investigators' hypothesis is that liposomal bupivacaine will decrease the postoperative~     pain and will be associated with more favorable postoperative outcomes when compared to plain~     bupivacaine following video-assisted thoracoscopic surgery.~   "
40541|NCT03036072|"~     This is an unblinded, single center, randomized study of infants with congenital heart~     disease undergoing cardiopulmonary bypass surgery, randomized to either the delayed rewarming~     intervention or to the standard of care (strict normothermia).~   "
40542|NCT03036059|"~     The Global Program for the Elimination of Lymphatic Filariasis (GPELF) has been in operation~     sing the year 2000, with the aim of eliminating the disease by the year 2020, following 5-6~     rounds of effective annual Mass Drug Administration (MDA). The treatment regimen is~     Ivermectin (IVM) in combination with Diethylcarbamazine (DEC) or Albendazole (ALB). In Ghana,~     MDA has been undertaken since 2001. While the disease has been eliminated in many areas,~     transmission has persisted in some implementation units that had experienced 15 or more~     rounds of MDA. Alternative intervention strategies, including twice yearly MDA and sleeping~     under insecticidal nets have significantly accelerated transmission interruption in some~     settings of high transmission intensity. Thus, it is evident that new intervention strategies~     could eliminate residual infection in areas of persistent transmission and speed up the LF~     elimination process. This study therefore seeks to test the hypothesis that biannual~     treatment of LF endemic communities will accelerate interruption of LF transmission.~      Two cluster randomized trials will be implemented in LF endemic communities in Ghana. The~     interventions will be yearly or twice-yearly MDA delivered to entire endemic communities.~     Allocation to study group will be by clusters identified using the prevalence of LF. Clusters~     will be randomised to one of two groups: receiving either (1) annual treatment with IVM+ALB;~     (2) annual MDA with IVM +ALB, followed by an additional MDA 6 months later. The primary~     outcome measure is the prevalence of LF infection, assessed by four cross-sectional surveys.~     Entomological assessments will also be undertaken to evaluate the transmission intensity of~     the disease in the study clusters. Costs and cost-effectiveness will be evaluated. Among a~     random subsample of participants, microfilaria prevalence will be assessed longitudinally. A~     nested process evaluation, using semi-structured interviews, focus group discussions and a~     stakeholder analysis, will investigate the community acceptability, feasibility and scale-up~     of each delivery system.~   "
40543|NCT03036046|"~     Non-randomized, multi-centre, open label, uncontrolled, multiple dose, phase IIa study.~      A total of 18 patients diagnosed with acute myeloid leukaemia (AML) scheduled for~     chemotherapy and expected to be neutropenic (<500 Absolute neutrophil count (ANC)/µl) for >10~     days will be treated. F901318 will be given in conjunction with fluconazole or posaconzaole~     in order to assess safe treatment regimens for both combinations.~   "
40544|NCT03036033|"~     This study evaluates the safety, feasibility and usability of a SaeboGlove rehabilitation~     device in the treatment of patients who have reduced ability to open their hand due to~     weakness after an acute stroke.~   "
40585|NCT03035500|"~     This clinical trial studies how well a long-term follow-up works in patients with prostate~     cancer after surgery. Long-term follow-up data may serve as a resource to help ask clinical~     questions, describe health-related quality of life and long-term complications related, and~     facilitate future studies focusing on interventions to improve health status and~     health-related quality of life in prostate cancer survivors.~   "
40545|NCT03036020|"~     The main aim of the NASPP study is to assess the efficacy and safety of the prehospital~     diagnosis of stroke using the Norwegian stroke ambulance concept. NASPP aims to demonstrate~     that anesthesiologists trained in pre-hospital critical care may perform acute stroke~     diagnostics by clinical assessment and CT scan interpretation and integrating these skills in~     the already existing organizational frame of the Norwegian prehospital EMS system.~      NASPP will systematically explore the Norwegian model of prehospital acute stroke diagnostics~     prior to the implementation of prehospital thrombolytic stroke treatment. NASSP will equip a~     regular ambulance staffed with a specially trained anesthesiologist and a specialized nurse.~     NASPP will perform the clinical part of the study in close co-operation with Østfold~     Hospital, Fredrikstad.~   "
40546|NCT03036007|"~     Background: Patients suffering residual disability after anterior decompression and fusion~     (ACDF) surgery for cervical disc disease may be prescribed physical activity (PPA) or~     neck-specific exercises (NSE). Currently, we lack data for the success of either approach.~     There is also a knowledge-gap concerning the use of internet-based care for chronic neck~     pain, inclusive of cervical disc disease. The scarcity of these data, and the high proportion~     of patients with various degrees of incapacity following ACDF, warrants increased efforts to~     investigate and improve cost-effective rehabilitation.~      Objective: To investigate the effectiveness of a structured, internet-based NSE program,~     versus PPA following ACDF surgery.~      Methods: This is a prospective, randomised, experimental, longitudinal multicentre study,~     that includes 140 patients with residual disability (≥30% on the Neck Disability Index; NDI)~     following ACDF for radiculopathy due to cervical disc disease. Patient recruitment occurs~     following attendance at routine clinical appointments, scheduled for 3-months post-surgery.~     Patients are then randomised to one of two groups (70 patients/group), scheduled for a~     3-month treatment of either internet-based NSE or PPA. Questionnaires on background data,~     pain and discomfort, physical and mental capacity, satisfaction with care, and health and~     workplace factors are completed, with physical measurements of neck-related function~     performed by independent test leaders blinded to randomisation. Measurements are performed at~     inclusion, after the 3-month treatments (end of treatment), and at a 2-year follow-up.~     Radiography will be completed at the 2-year follow-up. Preoperative data will be collected~     from the Swedish Spine Registry (Swespine). Data on healthcare consumption, drug use, and~     sick leave will be requested from the relevant national registers.~   "
40547|NCT03035994|"~     Altered loading is a causative factor for the development of knee osteoarthritis following~     anterior cruciate ligament reconstruction (ACLR), and real-time biofeedback may be an~     effective intervention to manipulate altered mechanical loading about the knee. The purpose~     of this study is to 1) determine if ACLR participants are able to acquire and retain various~     loading patterns using real-time biofeedback, 2) determine the effect of altered loading on~     lower extremity biomechanics during walking gait, and 3) determine the effect of altered~     loading on biochemical markers of collagen turnover and inflammation during walking gait.~   "
40548|NCT03035981|"~     Glycemic carbohydrates are associated with metabolic disturbances, such as type II diabetes,~     due to rapid digestion of starch into glucose. The specific properties of starch within these~     foods has been studied for the purpose of slowing their digestion rate and improving related~     physiological outcomes, such as gastric emptying rate. The current study investigated the~     relationship among starch digestion, gastric emptying rate and satiety in white and brown~     rice.~   "
40549|NCT03035968|"~     Stroke is the major cause for permanent disability in adults. It is still unclear, which~     physiotherapeutic approaches are most effective. The Bobath-concept is one of the most widely~     used approaches in stroke rehabilitation within the western world, although several studies~     have failed to demonstrate superiority and showed partially even inferiority compared to~     other physiotherapy approaches. The Vojta therapy is based on a completely different approach~     - the reflex locomotion. However to date no study has been performed for stroke. We designed~     a randomized clinical trial (RCT) to compare Vojta and conventional physiotherapy in patients~     with acute ischemic (AIS) or hemorrhagic stroke (ICH). This RCT will be the first trial to~     investigate improvement of postural control due to Vojta therapy in early rehabilitation of~     stroke patients, which is a very new approach in stroke-rehabilitation.~   "
40550|NCT03035955|"~     The purpose of this study is to measure the effects of azelaic acid on Demodex folliculorum~     counts and disease condition via a split face design in approximately twenty patients with~     mild to moderate rosacea. The investigators hypothesize that treatment of rosacea with~     azelaic acid will lead to a decreased Demodex folliculorum count as well as an improvement in~     lesion count and redness.~   "
40551|NCT03035942|"~     The aim of this study is to evaluate not only the occurrence of side effects, but the quality~     of the recovery (QoR-40 Questionnaire) of patients submitted to spinal anesthesia with~     administration of low doses (0.1 mg) of intrathecal morphine for the surgical treatment of~     fractures in one of the lower limbs and who will receive prophylactic ondansetron (4mg),~     dexamethasone (8mg) or placebo.~   "
40552|NCT03035929|"~     In this pilot study, the investigators will determine the response of the natriuretic peptide~     (NP) hormone system after a dose of intravenous dexamethasone (a steroid medication). The~     goal of the proposed project is to generate preliminary data that will be used to develop~     power calculations, inform cutoff ranges, and inform the timing of the NP response for larger~     subsequent studies aimed at developing a diagnostic test for NP deficiency, which has~     important implications for cardiometabolic risk. The investigators propose a pilot study in~     10 healthy lean individuals.~      Aim: To determine the range of distribution and time course of natriuretic peptide (NP)~     responses to a single dose of dexamethasone IV 4 mg in healthy lean individuals.~      Hypothesis: Determination of the NP responses (the range and time course of changes in NP~     levels) to dexamethasone in 10 healthy individuals will inform the time course and frequency~     of blood sampling in a definitive prospective study designed to understand the diagnostic~     values/cutoffs of a diagnostic test, as well as enable investigators to perform a sample size~     calculation for a definitive prospective study.~   "
40553|NCT03035916|"~     This study evaluates the effect of transversus abdominis plane(TAP) block combined with~     general anesthesia on perioperative stress response in patients undergoing radical~     gastrectomy. One third of participants will receive TAP block combined with general~     anesthesia, another one third of participants will receive epidural anesthesia combined with~     general anesthesia, while the rest will receive only general anesthesia.~   "
40554|NCT03035903|"~     The goal of this clinical protocol is to perform a randomized crossover study to determine~     the energy cost of holding the MedGem® device above a person's normal resting metabolic rate~     (RMR) compared to not holding the MedGem® device.~   "
40555|NCT03035890|"~     This study includes the additional use of radiation therapy in combination immunotherapy in~     order to determine whether the radiation may improve the response of non-small cell lung~     cancer to immunotherapy and to monitor any side effects.~   "
40556|NCT03035877|"~     This study's purpose is to examine the effectiveness of a promising intervention for emerging~     adults (EAs) with alcohol and other drug (AOD) abuse and justice involvement in achieving the~     ultimate outcome of reduced criminal activity. The study will also examine that effect on~     intermediate outcomes as follows: 1) reduced AOD use; 2) greater gainful activity (increased~     educational success, employment and housing stability; decreased antisocial peer involvement~     and relationship conflict); 3) and greater improvement in self-regulation (self-efficacy,~     goal directedness and responsibility taking). The intervention to be tested is Multisystemic~     Therapy-Emerging Adults (MST-EA). MST-EA is an adaptation of MST, a well-established,~     effective intervention for antisocial behavior in adolescents.~   "
40557|NCT03035864|"~     The proposed phase II study is a single-centre, randomized, double masked, parallel arm,~     vehicle-controlled trial, designed to evaluate the preliminary efficacy and safety of rhNGF~     eye drops at 20 µg/ml concentration administered six times daily for 8 weeks in patients who~     underwent cataract and corneal refractive surgery, both known to damage the corneal sensory~     nerve plexus.~      After confirmation of inclusion and exclusion criteria all eligible patients will be~     randomized at 2:1 ratio to rhNGF or vehicle control treatment with 8 weeks of study~     treatments administration with 4 weeks Follow-up.~   "
40558|NCT03035851|"~     The estimated annual cost of dementia in Canada is $15 billion, with a projected cumulative~     economic burden of $800 billion by 2038. Effective prevention of dementia at a population~     level will need to include lifestyle factors such as promoting higher levels of physical~     activity. Physical inactivity is a modifiable risk factor for Alzheimer disease (AD) and~     cognitive decline, but the mechanisms by which physical activity exerts its protective effect~     on the brain remain unknown. Motivated by the need to develop strategies to prevent and treat~     AD and related dementias (ADRD), the investigators' overall research goal is to discover why~     the aging brain develops ADRD. To achieve this goal the investigators adopt a translational~     physiology approach (i.e., study of physiology from molecule/cell to population) to~     investigate how exercise improves cognitive performance, and the underlying mechanisms by~     which exercise prevents and/or slows down age-related declines in brain health and cognition.~     This approach allows the investigators to determine how physiological function is related to~     ADRD, with important implications for health. The investigators' prior work demonstrated a~     significant relationship between fitness, vascular regulation and cognition in older adults~     free of overt disease. These findings have implications for vascular cognitive impairment and~     ADRD, in which hypoperfusion and dysregulation of cerebral blood flow are thought to be~     important pathophysiological factors. The investigators' central hypothesis is that regular~     aerobic exercise mitigates age-related decreases in vascular function and cerebrovascular~     reserve, which in turn benefits cognition. Work by the investigators and others has provided~     the necessary data justifying a randomized controlled trial to evaluate the role of exercise~     in the prevention of ADRD.~      The investigators are well equipped to undertake this trial; the investigators have dedicated~     institutional support and necessary expertise in vascular regulation, cognition, aging,~     neuroimaging and genetics.~      The overall objective of this proposal is to test an exercise intervention for secondary~     prevention of ADRD in adults between 50 and 80 years old who are at increased risk for ADRD~     (with memory impairment symptoms but without dementia). The rationale for this trial is the~     urgent need for dementia prevention: an exercise intervention, which harnesses a~     translational physiology framework, holds such promise. The investigators will conduct this~     trial to determine the effects of aerobic exercise on the development of age-associated~     cognitive decline and dementia. The exercise intervention is designed with input from Alberta~     Health Services, the universal healthcare provider for Albertans, so that the intervention~     can be readily adopted into clinical practice if this trial is successful. The trial will~     address three specific aims.~      SPECIFIC AIM 1: Determine the independent effect of exercise on cognitive performance in~     previously inactive older adults at increased risk of ADRD. The investigators hypothesize~     that participants randomized to our six-month aerobic exercise intervention will perform~     better on cognitive tests, compared to control participants randomized to a stretching-toning~     exercise group.~      SPECIFIC AIM 2: Determine underlying biological mechanisms that influence cognitive~     performance after exercise training. The investigators hypothesize that exercise improves~     cognition due to changes at molecular/cellular (biomarkers), vascular (cerebral blood flow,~     cerebrovascular reserve), anatomical and functional (neuroimaging), and behavioural (sleep~     quality) levels. Further, the investigators hypothesize that ADRD-specific genetic risk~     scores, reflective of targeted genetic variants, moderate exercise-related cognitive and~     brain outcomes.~      SPECIFIC AIM 3: Determine the extent to which changes in cognition, resting cerebral blood~     flow and cerebrovascular reserve persist 12 months after participants complete a 6-month~     exercise training intervention. The investigators hypothesize that the effects of improved~     aerobic fitness will be maintained over time as a function of persistent lifestyle changes~     and behavioural support programs. This trial will provide evidence needed to make clinical~     recommendations for exercise programs in adults at risk for ADRD, with the goal of preventing~     dementia. Given the investigators' extensive stakeholder input, this intervention will be~     easily translated to other jurisdictions. This research into the mechanisms of effect for~     exercise will identify patient subgroups most likely to benefit, surrogate outcome markers~     for use in future trials to refine intervention dose/duration, and new therapeutic targets~     for future interventions.~   "
40559|NCT03035838|"~     Traumatic brain (TBI) injury is the major cause of morbidity and mortality worldwide~     especially in population under 40 years of age and has a significant socioeconomic impact.~     TBI results from the head impacting with an object or from acceleration/deceleration forces~     that produce vigorous movement of the brain within the skull, with the resultant mechanical~     forces potentially damaging neurones and blood vessels and causing irreversible, primary~     brain injury. Primary injury leads to activation of cellular and molecular responses which~     lead to disruption of the blood-brain barrier causing the brain to swell. As the intracranial~     space is not expandable (i.e. is fixed), this swelling leads to increase in intracranial~     pressure (ICP) compromising blood supply to the rest of the brain leading to secondary brain~     injury. As we are unable to reverse the primary injury, current protocols use supportive~     measures to control the ICP and ensure optimal blood supply to the brain in an attempt to~     minimize secondary injury. Our understanding of the factors involved in the initiation and~     propagation of brain swelling in TBI is growing and the role of neuroinflammatory cytokines~     in this process is increasingly recognized. In preclinical models of TBI, a specific~     inflammatory cytokine termed substance P (SP) is found to be associated with blood-brain~     barrier disruption and development of brain oedema in the immediate phase following injury.~     The aim of this study is to examine the role of SP in the genesis of cerebral oedema and~     elevation of ICP and thus secondary injury following human TBI. This would be achieved by~     blocking SP function with a SP receptor antagonist Fosaprepitant (IVEMEND®, Merck) in the~     first 24 hours following TBI and then continuously measuring ICP and assessing the evolvement~     of TBI using magnetic resonance imaging.~   "
40560|NCT03035825|"~     This randomized control trial aims to investigate the efficacy of oral moisturizing jelly in~     head and neck cancer patients with xerostomia.~   "
40561|NCT03035812|"~     Metabolic acidosis recovers a wide range of diseases in which an oral alkalinization could be~     useful. This therapeutic intervention has been said to increase extracellular volume leading~     to rising blood pressure. No prospective data has been published in clinical routine. Here,~     investigators propose to follow patients in which an oral alkalinization is indicated: blood~     pressure, body weight, and a clinical evaluation of the extracellular compartment will be~     performed at the beginning and during the follow-up of participants. The principal criterion~     of evaluation will be the variation in the extracellular compartment.~   "
40562|NCT03035799|"~     This pilot study proposes to gain a better understanding of the health benefits of the~     popular paleo-diet in patients with irritable bowel syndrome (IBS) and explore underlying~     mechanisms of benefit.~   "
40563|NCT03035786|"~     This is a survey of airway codes, which are emergency mobile phone requests for anaesthetic~     help to manage acute airway crises in the hospital (out of theatre, out of Surgical Intensive~     Care Unit, SICU).~      The anaesthetists are doctors trained in advance airway management. Patients in the hospital~     may suffer airway crises e.g. airway obstruction or need for tracheal intubation (insertion~     of breathing tube) for various reasons. The on call SICU anaesthetists responds to the airway~     code by attending the patient in need and managing the patient at their own discretion.~      Airway management will depend on the anaesthetist's knowledge, skills and experience. it will~     also depend on the available airway equipment.~      We plan to evaluate airway codes for a 24 month period. Parameters include: type of incident;~     patient factors (including airway assessment); type of equipment used; anaesthetic drugs~     used; airway management chosen by the attending anaesthetist; and, airway complications.~   "
40564|NCT03035773|"~     OBJECTIVE: The purpose of this study is to identify an SCP process that is patient-centered,~     effective in promoting appropriate survivorship care and can be successfully implemented for~     patients with different types of cancer who are being treated in a broad range of clinical~     settings. There is a need for research related to SCP that prioritizes outcomes that are most~     highly valued by patients, caregivers and clinical stakeholders.~   "
40565|NCT03035760|"~     This Phase I study is an open label multiple ascending dose evaluation of the safety and PK~     of oxfendazole (3, 7.5, or 15 mg/kg) given orally daily to healthy adult men and nonpregnant~     women aged 18-45 followed by a single dose cross over trial evaluating the safety and~     pharmacokinetics of a single dose of oxfendazole (3 mg/kg) given following an 8 hour fast or~     following a high fat meal. The study duration will be approximately 12 months with each~     subject participation lasting approximately 6 weeks. In the multiple ascending dose~     evaluation, between 8 and 24 subjects will be enrolled; each dose group will be comprised of~     eight volunteers. To enhance safety, one sentinel subject will be dosed for five days and~     monitored for 7 days from the time of the first dose for predefined adverse events. If there~     are no predefined safety events, a second sentinel subject will be enrolled and followed for~     a total of 7 days. If there are no predefined safety signals identified for either of these~     two sentinel subjects, the remaining subjects in the group will be enrolled. After all eight~     subjects have completed the 10 day follow up period, an electronic safety review of the~     electronic data will be performed. If none of the predefined safety events have occurred DMID~     will approve enrollment into the second dose group (7.5 mg/kg oxfendazole daily x 5 days) and~     will be monitored for a total of 7 days each for predefined adverse events prior to enrolling~     the remaining subjects in the group. After the 10 day follow up period has been completed for~     group 2, an electronic safety review will be completed and if no predefined events have~     occurred two sequential subjects (one at a time with 7 days between each subject) will be~     enrolled into the third dose group (15 mg/kg oxfendazole daily x 5 days) and will be~     monitored for a total of 7 days each for predefined safety events prior to enrolling the~     remaining subjects in the group. In the food effects evaluation, 12 subjects will be enrolled~     into the single dose cross over group where half of the subjects will initially receive a~     single dose of 3 mg/kg of oxfendazole following an 8 hour fast and the other half will~     receive a single dose of 3 mg/kg of oxfendazole following a high fat meal. Subjects will then~     cross over to receive a single dose following a high fat breakfast or fasting period (water~     is permitted). All subjects will have received a dose of oxfendazole following both a fasting~     period and a meal. The primary objectives are: 1) To assess the safety of oxfendazole~     administered daily for five days; and 2) To assess the safety of oxfendazole administered as~     a single dose with or without food.~   "
40573|NCT03035656|"~     The following is a double blinded, randomized controlled clinical trial to test the~     hypothesis that a single epidural injection of Ropivaciane® intra operatively will:1) Single~     intra-operative epidural injection of Ropivaciane® will result in decreased postoperative~     pain and opioid use in both minimally invasive (MIS) and open lumbar fusion patients; 2)~     Decreased postoperative pain will lead to improved clinical outcomes; and 3) Elucidate if~     there are differences in pain management between MIS and open surgical procedures. The~     proposed study will add novel information to current knowledge by 1) exploring of the effects~     of intra-operative single epidural injection analgesic on patients receiving MIS compared to~     open surgery, and 2) investigate potential immediate and short-term functional improvements~     gained from intra-operative single injection of Ropivaciane®.~   "
40574|NCT03035643|"~     This study is for participants who have been diagnosed with an acute aortic~     dissection/intramural hematoma (also known as a DeBakey I or Stanford type A dissection/~     intramural hematoma). In a healthy aorta (the vessel that supplies blood to most of the body)~     the blood flows freely through the main lumen (a space inside the vessel where blood flows).~     The participants involved in this study have a tear that has separated the inner layer of the~     aorta wall and created a secondary channel (false lumen) in addition to the main channel~     (true lumen). The blood is now flowing through both channels.~      The purpose of this study is to investigate the feasibility and safety of the AMDS (stent).~     The use of this device may allow healing of the false lumen (separated channel). If the AMDS~     together with conventional surgery is effective, it is believed that this could lead to the~     repair of the dissection (tear) in the treated aorta,~   "
40575|NCT03035630|"~     This is an open label, randomized phase II trial. Eligible subjects will be randomized in a~     1:1 ratio and stratified for known prognostics variables to one of two first-line medication~     treatment arms. Once disease progression has been documented, and following a required~     inter-line washout period, subjects will receive either second-line medication treatment or~     discontinue treatment, per discretion of treating investigator.~   "
40576|NCT03035617|"~     Early post-operative pain and discomfort after laparoscopic repair remains a concern for~     patients requiring hospital stay and parenteral narcotic analgesics . This quite often proves~     to be a hindrance in early ambulation, enhances patient discomfort and prevents early~     discharge from hospital.~      Local anesthetics infiltration at wound site after various procedures is known to be~     effective in reducing immediate post-operative pain , . In case of laparoscopic ventral~     hernia repair, delivering local anesthetic at site of mesh application can be achieved by~     soaking the mesh in local anesthetic solution before application. To date there is no~     evidence regarding impact of soaking mesh in bupivacaine solution before application in case~     of laparoscopic ventral hernia repair.~      OBJECTIVE:~      Primary Objective:~      To evaluate impact of impregnating mesh in .5% bupivacaine solution as compared to normal~     saline solution on post-operative pain after laparoscopic ventral hernia repair.~      Secondary Objective:~      To evaluate impact of impregnating mesh in .5% bupivacaine solution as compared to saline~     solution on length of hospital stay after laparoscopic ventral hernia repair.~      Study Sample:~      Patients with uncomplicated ventral abdominal wall hernia presenting at general surgery~     clinics of AKUH Karachi who are planned to undergo laparoscopic repair and meet eligibility~     criteria of inclusion into trial.~      SETTINGS:~      Study will be conducted in General Surgery Section of Aga Khan University Hospital, Karachi.~      Patients will be evaluated in clinic at the time of presentation regarding eligibility to~     participate in study. Written informed consent will be taken in clinic. A copy of the consent~     form will be handed over to the patient. Clinical Trial Unit will be informed of the~     scheduled date and time of the operation. Allocation will be done by the staff at clinical~     trial unit which will be kept undisclosed to the investigators, patients and outcome~     assessors. Clinical Trial Unit will provide the solution for soaking mesh in coded form~     according to treatment arm allocation. After the operation first assessment of pain will be~     done six hours post-operatively using VAS. Second assessment will be done at twenty four~     hours from end of operation. This assessment will be done directly if patient is admitted in~     the hospital or will be done on telephone if patient is discharged home.~      FOLLOW UP:~      Pain assessment will be done using visual analogue scale (VAS). This is validated score to~     measure level of pain. It ranges from zero to ten. Score of 0 means no pain and score of ten~     means worst pain one can ever have. Score will be assessed at 6 and 24 hours from procedure.~   "
40577|NCT03035604|"~     The goal of this research study is to learn about ways to check for malnutrition (loss of~     weight/appetite that may result in health problems) that is due to cancer or cancer~     treatment.~      This is an investigational study.~      Up to 284 participants will be enrolled in this study. All will take part at MD Anderson.~   "
40578|NCT03035591|"~     This is a first-in-man study to assess the safety and tolerability and to characterise the~     pharmacokinetics of ODM-207.~   "
40579|NCT03035578|"~     This research aims to study what the baby's body does with morphine and how morphine works in~     the baby's body. One hundred newborn babies will be enrolled in this study. With a better~     understanding of the drug doctors and nurses will have more information and better administer~     the drug in case of pain, stress or discomfort.~   "
40580|NCT03035565|"~     Cognitive Intervention to Improve Memory in Heart Failure patients~   "
40581|NCT03035552|"~     The purpose of this study is to determine if intensive training of Non-Nutritive Suck (NNS)~     using contingent positive reinforcement with mother's voice can improve the feeding outcomes~     of infants with congenital heart defect (CHD) at high risk for oral motor problems.~   "
40582|NCT03035539|"~     The purpose of this study is to investigate whether a rehabilitation programme can improve~     the quality of life and reduce morbidity in patients with atrial fibrillation.~      In addition, the study will map the economic costs and benefits of such a rehabilitation~     programme.~   "
40583|NCT03035526|"~     In this study, our aim is to show the relation between sex hormones and PAT and to confirm~     whether PAT is associated with coronary artery calcification (CAC) in different testosterone~     levels in the males.~   "
40584|NCT03035513|"~     Continuous Spikes and Waves during Sleep (CSWS) is a rare paediatric epileptic~     encephalopathy. Even if the correlation between the severity of the epilepsy and the~     cognitive consequences is well established, the mechanisms involved in epileptic cognitive~     degradation are complex and poorly understood. In CSWS, there are many arguments for the~     implication of cortical and subcortical cerebral structures. Among them the thalamus seems to~     play a crucial role. In fact it is strongly implicated in the sleep and this function is~     determining for learning. Moreover, it is part of the propagation pathway of generalized~     forms of epilepsy like absences in animal studies. Unfortunately there is no animal model for~     CSWS to confirm this theory. In human studies, few cases are caused by thalamic injuries but~     most of the time conventional MRI is normal. Despite few literature on CSWS, some studies~     reported abnormal functional connectivity especially in the thalamus.~      The investigators hypothesize that the first utilisation of diffusion tensor imaging (DTI)~     and tractography will be useful in CSWS to confirm the implication of a~     cortico-thalamo-cortical network showing an abnormal structural connectivity. The~     investigators will try to determinate if a particular thalamic nucleus is concerned and~     demonstrate a link between the disease severity (duration and cognitive consequences) and the~     importance of structural abnormalities.~      Using resting state functional MRI (fMRI), the investigators will also try to investigate the~     default mode network. Its implication was also suggested in the literature.~   "
40586|NCT03035487|"~     The investigational protocol describes a small case series designed to compare three imaging~     modalities for use in visualizing prostate cancer.~      The three modalities to be tested are: transrectal micro-ultrasound , and conventional~     resolution transrectal ultrasound (LR-TRUS) (both as implemented on ExactVu, the~     multi-frequency novel micro-ultrasound system under investigation), and multi-parametric MRI~     (mpMRI).~      These modalities will be used for guiding systematic (standard, random, extended sextant)~     plus image-guided targeted prostate biopsies among men with known cancer and an indication~     for prostate biopsy.~      In the case of mpMRI, biopsy will be performed under micro-ultrasound guidance with the~     radiology report used for targeting.~   "
40587|NCT03035474|"~     CONNECT-HF is a large-scale, pragmatic, cluster-randomized clinical trial to evaluate the~     effect of a customized, multifaceted, health system-level quality-improvement (QI) program~     compared with usual care on heart failure (HF) outcomes and HF quality-of-care metrics.~   "
40588|NCT03035461|"~     Age-related macular degeneration (AMD) is the leading cause of blindness in the elderly~     population of the industrialized world. AMD is a progressive degenerative disease affecting~     the central area of the retina, responsible for distinct vision. Vision loss arises from~     aberrant new vessel growth which causes the accumulation of blood or fluid within the~     retina's thickness and eventually leads to permanent scarring. The two major forms of AMD are~     exudative, or neovascular or wet, and non-exudative, or dry.~      Vascular endothelial growth factor (VEGF) represents the key modulator of the angiogenetic~     process and is involved in the pathophysiology of AMD. Anti VEGF therapies are used to treat~     wet-AMD.~      After diagnosis and explanations of the practionner, the patients and their close relatives~     have still frequently many questions about the intravitreal injections, the prognosis, the~     risk of visual impairment, etc. Few teams have studied the modalities of diagnosis~     announcement and the understanding of the patients on the disease course.~      The aim of this study is to evaluate the feelings after the AMD diagnosis announcement as~     well as the understanding of the possibilities of treatment and the clinical surveillance.~   "
40589|NCT03035448|"~     The goal of this research study is to learn about advanced cancer patients' preferences about~     how psychology services are introduced.~      This is an investigational study.~      Up to 110 participants will be enrolled in this study. All will take part at MD Anderson.~   "
40590|NCT03035435|"~     In the last years, a lot of surgical fast track programs (SFTP) have been created and~     developed. This is due to the steady growing number of interventions on knee and hip; after~     the surgical treatment, a period of physical rehabilitation (PR) is established to be useful~     and effective, it usually takes 2-3 weeks. The recovery of strength, range of motion (ROM),~     independence, the reduction of pain and disability are the aims of PR. With the SFTP and a~     specific rehabilitation program named fast track rehabilitation (FTR) these times can be~     reduced. First of all because the length of stay (LOS) it's also caused by organizational~     problems of the hospitals, not only for the factors related to the patient. It's already been~     demonstrated that an early mobilization decreases the risk of thromboembolic complications~     and of pain, furthermore an early rehabilitation increase the patient autonomy and reduces~     the lost of residual abilities. Moreover a PR program studied for fast track patient will~     reduce minimum by a 50% the LOS in hospital, decreasing so the sanitary efforts that are~     always a problem for all the countries. The aim of this study is therefore to propose a fast~     track rehabilitation program based on an 8 days program for hip and knee arthroplasty being~     operated with an SFTP.~   "
40591|NCT03035422|"~     Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is the only treatment option~     with a significant chance of healing in acute myeloid leukemia (AML) or refractory multiple~     relapses after chemotherapy. However, all patients with an indication of allo-HSC can not~     benefit because of two limitations: the toxicity of the treatment and graft shortage~     available.~   "
40592|NCT03035409|"~     The goal of this clinical research study is to learn if anamorelin can help to decrease~     cancer-related fatigue in patients with advanced cancer.~      The safety of this drug in combination with physical activity will also be studied.~      This is an investigational study. Anamorelin is not FDA approved or commercially available.~     Its use in combination with physical activity is investigational. The study doctor can~     explain how the study drug is designed to work.~      Up to 38 participants will be enrolled in this study. All will take part at MD Anderson.~   "
40593|NCT03035396|"~     The primary objective of this study is device feasibility of the Diassess Influenza A and B~     Test~   "
40594|NCT03035383|"~     Thyroidectomy for large thyroid tumor poses a problem of cosmetics, especially in terms of~     wide post-operative scar and prominent neck wrinkles. In this manuscript, we performed~     purse-string suture for the first time for the closure of skin defect after thyroidectomy of~     large thyroid tumors which resulted in better cosmetics as compared to the conventional~     suturing method.~   "
40595|NCT03035370|"~     The study is a Phase I, first in human, monocenter study, aiming at assessing the safety and~     immunogenicity of a genetically detoxified pertussis toxin (PT) when administered via the~     cutaneous route with Viaskin patches to healthy volunteers at 2 different doses of 25 mcg or~     50 mcg PT protein compared to Viaskin placebo.~      Two cohorts of 30 subjects will be successively enrolled. Safety of the product will be~     assessed throughout the 10-week study and its immunogenicity will be assessed at regular~     intervals with collection of blood samples for immunological analyses.~      Four weeks after the second Viaskin application (at Day 42 of the study), all subjects will~     receive a dose of diphtheria-tetanus-pertussis vaccine (Boostrix® dTpa) to ensure the optimal~     recall of their immunity against pertussis.~   "
40596|NCT03035357|"~     The goal of this clinical research study is to learn about biomarker changes in patients who~     have primary prostate cancer after receiving Darzalex (daratumumab) and then have a~     prostatectomy (the surgical removal of the prostate) as part of their standard care.~     Biomarkers are found in the blood/tissue and may be related to your reaction to the study~     drug.~   "
40597|NCT03035344|"~     Study of the intermediate metabolism in children diagnosed with ALL compared to healthy~     matched controls.~   "
40610|NCT03035162|"~     The aim of the present study is to evaluate the possible effect of using dual-tDCS combined~     with conventional physical therapy on lower limb function in stroke patients.~   "
40598|NCT03035331|"~     This phase I/II trial studies the best dose and side effects of dendritic cell therapy,~     cryosurgery and pembrolizumab in treating patients with non-Hodgkin lymphoma. Vaccines, such~     as dendritic cell therapy made from a person's tumor cells and white blood cells may help the~     body build an effective immune response to kill tumor cells. Cryosurgery kills cancer cells~     by freezing them. Monoclonal antibodies, such as pembrolizumab, may interfere with the~     ability of tumor cells to grow and spread. Giving dendritic cell therapy, cryosurgery and~     pembrolizumab may work better at treating non-Hodgkin lymphoma.~   "
40599|NCT03035305|"~     SMC LNS Mali is a interventional matched-pair clustered cohort carried out between August and~     November 2017 in 18 health areas in Kolokani Circle, Koulikoro region, Mali.~      The objective of this study is to determine whether the association SMC and LNS reduces the~     number of confirmed malaria cases among children 6-59 months during the monthly SMC~     distribution sessions.~   "
40600|NCT03035292|"~     Sensitivity and specificity of current screening methods for congenital cataracts in neonates~     is poor. This results in delayed diagnosis and management which can decrease the visual~     prognosis following cataract surgery. It also results in many false positives with resultant~     unnecessary healthcare costs in specialist paediatric ophthalmology services. The~     investigator has developed a new digital technique to improve the accuracy of screening for~     congenital cataract and this study will compare this new test with the current test~     performed.~   "
40601|NCT03035279|"~     This is a multicenter, open-label, Phase 1 study of SC-006 given as a single agent and in~     combination with ABBV-181 in participants with advanced colorectal cancer (CRC), and consists~     of Part A (single agent SC-006 dose regimen finding), followed by Part B (single agent SC-006~     dose expansion), and Part C (SC-006 and ABBV-181 combination escalation and expansion). Part~     A (dose regimen finding) will involve dose escalation and possible dose interval modification~     to define the maximum tolerated dose (MTD) and/or recommended Part B dose and schedule. Part~     B (dose expansion) will enroll additional participants who will be treated with a study drug~     dose at or below the MTD determined in Part A. Part C is dose escalation of SC-006 and fixed~     dose of ABBV-181 in combination. Recommended dose cohort of SC-006 with ABBV-181 will be~     expanded.~   "
40602|NCT03035266|"~     The investigators will compare differences in quadriceps strength, leg girth, and functional~     outcome scores between two groups of patients after weeks 6 and 12 as well as 6 months~     following meniscus or articular cartilage repair/restoration requiring 6 weeks of non-weight~     bearing or limited weight bearing status in a brace at 0° degrees of knee extension. One~     group will receive BFR with standard post-operative rehabilitation for 12 weeks followed by~     the standard protocol progression for the remainder of the treatment program. The other group~     will receive standard post-operative rehabilitation without BFR for the duration of treatment~     program.~   "
40603|NCT03035253|"~     The purpose of this study is to test the safety and efficacy of an experimental drug,~     OMP-305B83, when given in combination with FOLFIRI. OMP-305B83 is a humanized bispecific~     monoclonal antibody and was developed to target cancer stem cells. Based on preclinical~     studies, it is believed that OMP-305B83 may block the growth of cancer stem cells and may~     also impair the productive growth of new blood vessels, which tumors need to grow and spread.~      The study is sponsored by OncoMed Pharmaceuticals, which is referred to as OncoMed or the~     Sponsor.~   "
40604|NCT03035240|"~     The purpose of this prospective, randomized, controlled three-year study is to compare the~     effect of a year-long financial education program versus usual care on health outcomes in~     single mother low income households.~   "
40605|NCT03035227|"~     The purpose of this study is to test if catheter ablation is better than medication therapy~     at treating arrhythmias originating from the upper and/or lower chambers of the heart in~     order to allow the heart to beat properly.~   "
40606|NCT03035214|"~     Most preterm babies require supplemental oxygen for a variable period of time, up to several~     weeks or months after birth. The aim of oxygen therapy is to achieve adequate oxygen supply~     to the tissues without causing oxygen toxicity and oxidative stress. The current routine~     monitoring relies on oxygen saturation by pulse oximetry without identifying the underlying~     pathology, as lung parenchyma and pulmonary vascular disease can be contributed in~     pathophysiology at variable degrees.~      Steroids usage for prevention of Bronchopulmonary dysplasia also has been shown to have~     adverse neurodevelopmental outcome. Available data are conflicting and inconclusive;~     clinicians must use their own clinical judgment to balance the adverse effects of~     Bronchopulmonary dysplasia with the potential adverse effects of treatments for each~     individual patient. Very low birth weight infants who remain on mechanical ventilation after~     1 to 2 weeks of age are at very high risk of developing Bronchopulmonary dysplasia.~      When considering corticosteroid therapy for such an infant, clinicians might conclude that~     the risks of a short course of glucocorticoid therapy to prevent Bronchopulmonary dysplasia~     are warranted.~   "
40607|NCT03035201|"~     The parent trial (COcoa Supplement and Multivitamin Outcomes Study, COSMOS; NCT02422745) is a~     randomized clinical trial of cocoa extract supplement (containing a total of 600 mg/d~     flavanols, including 80 mg. (-)-epicatechins), and a standard multivitamin supplement to~     reduce the risk of cardiovascular disease and cancer among men aged 60 years and older and~     women aged 65 years and older. A cognitive ancillary study (COSMOS-Mind) is being conducted~     among men and women, 65 years and older, who are enrolled in COSMOS and will examine whether~     the cocoa extract supplement or the multivitamin supplement improves cognitive function and~     reduces risk of cognitive impairment, including AD and other related types of dementia.~   "
40608|NCT03035188|"~     In this study patients with resectable basal cell carcinoma (BCC) who usually undergo surgery~     without prior anticancer treatment will be treated with antitumor medication. But since BCC~     is mainly localized in clearly visible regions of the body, as e.g. the face, there is also a~     need to reduce scars as a consequence of surgery which will be accomplished by neoadjuvant~     therapy.~      The used medication - vismodegib - displays controllable adverse events and shows a good~     efficacy for reduction of BCC lesions. It is expected that the neoadjuvant setting will lead~     to minor surgical intervention thus minimising surgical risks and scars for the patients.~   "
40609|NCT03035175|"~     This study examines the effectiveness of utilizing video laryngoscopy to give real-time~     guidance during neonatal intubations to improve residents' success at performing intubations.~   "
40611|NCT03035149|"~     Dyspnea is a common complaint in obese patients. The mechanisms behind this dyspnea and the~     effects of weight loss on dyspnea are not completely understood. The objectives of this study~     were to examine the relationships between exercise parameters and dyspnea in obesity and~     assess the effects of weight loss.~      The investigators compared pulmonary function, exercise performance and dyspnea in 34~     patients with abdominal obesity and metabolic syndrome (MS) against 34 age and sex-matched~     controls. The study also assessed within-group changes in physiology and symptoms in a subset~     of patients following participation in a weight management program.~      Because obesity is a heterogeneous condition, with variable genetic associations,~     co-morbidities and distributions of adipose tissue, the study focused on patients with~     abdominal obesity who met diagnostic criteria for metabolic syndrome.~   "
40612|NCT03035136|"~     Retrospective analysis on colonoscopies in the endoscopy unit of the Lyell McEwin Hospital.~   "
40613|NCT03035123|"~     The EduStra-HF study will examine the impact of an intensive therapeutic education on~     patients discharged from hospital after an episode of acute heart failure (HF).~      Patients will be randomized into two groups: one will receive usual care monitoring and one~     will receive a specific educational monitoring programme for 1 year.~      All patients will meet with a specialized therapeutic education nurse before discharge.~      The effect of the intensive education on HF rehospitalization and quality of life will be~     examined.~   "
40614|NCT03035110|"~     The current research is being undertaken as part of a professional doctorate in clinical~     psychology, which aims to evaluate the feasibility of a group programme to address self-harm~     within 23 days, to provide evidence for a controlled trial. The intervention will include~     four group sessions conducted over 2 weeks, based on Dialectical Behavioural Therapy.~     Specifically the aims are to determine 1) means and a standard deviation for two pre and post~     treatment outcome measures in order to estimate sample size for the main study, 2) the need~     for an inpatient intervention for self-harm measured by number of participants eligible and~     accepting of the treatment, 3) retention of participants for 4 groups given the predicted~     short stays of patients on wards, and 4) the acceptability of the research process for this~     client group through feedback.~   "
40615|NCT03035097|"~     The purpose of this research study is to establish a research database and biorepository for~     patients at National Jewish Health (NJH) who served in Operation Iraqi Freedom (OIF) or~     Operation Enduring Freedom (OEF). This study will also include civilian contractors who~     worked as part of these military operations in Iraq or Afghanistan. The biorepository would~     store blood samples obtained from these patients during a clinic visit. The research database~     would store prospectively and retrospectively collected clinical and exposure data that would~     enable us to comprehensively characterize each case.~   "
40616|NCT03035084|"~     Several studies have demonstrated that D2 treatment is associated with a decrease in 25(OH)D3~     level and therefore have proposed that D3 would be preferable in term of raising total~     25(OH)D level. The investigators postulate that the D2 treatment-associated decrease in~     25(OH)D3 level may be related to an increase in total 25(OH)D level rather than being~     specific to D2 treatment, and thus there would be a D3 treatment-associated decrease in~     25(OH)D2 level.~      The investigators plan to conduct a double-blind placebo-controlled trial to examine the~     effect of D3 treatment on 25(OH)D2 level and the effect of D2 treatment on 25(OH)D3 leve~   "
40617|NCT03035071|"~     The MIOMIE trial is a prospective randomized controlled study comparing open and laparoscopic~     gastric tube formation in Ivor Lewis esophagectomy. Aim of this trial was to compare the~     minimally invasive approach with the standard open procedure regarding morbidity and~     mortality.~   "
40618|NCT03035058|"~     The purpose of this study is to evaluate the efficacy and safety of vedolizumab intravenous~     (IV) in non-end-stage primary sclerosing cholangitis (PSC) participants with underlying~     inflammatory bowel disease (IBD).~   "
40619|NCT03035045|"~     This randomized controlled trial, compares perioperative and postoperative pain score by~     using visual analog scale in pregnant women undergoing amniocentesis. The experimental group~     will be given oral paracetamol premedication whereas the controlled group will be given oral~     placebo premedication.~   "
40620|NCT03035032|"~     The objective of this study is to evaluate the safety, efficacy, and impact on quality of~     life (QoL) of ELIGARD® in hormone-dependent prostate cancer patients in Asia.~   "
40621|NCT03035019|"~     Stress and anxiety can worsen quality of life in patients seen in primary care practices.~     This project is set in UPMC primary care practices (CMI) to evaluate how the availability of~     a virtual stress management program can help patients reduce stress and anxiety and improve~     their quality of life. The project will analyze the efficacy of the virtual stress management~     program at these practices so that it can then be utilized effectively in other medical~     settings where it can be offered as a part of clinical care to reduce stress and anxiety and~     improve the quality of life of medical patients who could benefit from a reduction in stress.~     This research is being piloted at these sites in the hopes of publishing results that show~     that it can be implemented in other practices throughout the country.~      Additionally, at other UPMC CMI primary care sites, de-identified data will be collected in~     order to serve as a comparison.~   "
40622|NCT03035006|"~     This is a phase I/II dose-escalation study of lipotecan based concurrent chemoradiotherapy in~     hepatocellular carcinoma with portal vein tumor thrombosis.~   "
40623|NCT03034993|"~     The purpose of this study is to determine if an automated text message intervention is~     beneficial for homeless patients in reducing their hospital visits, increasing their primary~     care appointments, and help them increase medication adherence.~   "
40632|NCT03034850|"~     Cytoreductive surgery (CRS) with hyperthermic intraperitoneal peroperative chemotherapy~     (HIPEC), indicated for patients with peritoneal metastases from digestive or gynecological~     malignancies alike, demonstrates a considerable impact on hemostatic metabolism, both on~     platelet and on coagulation level. The potential hemostatic interference in CRS and HIPEC is~     phase dependent. This study demonstrates the combined use of ROTEM (rotational~     thromboelastometry), PACT (platelet activation test) and CAT (thrombin generation test)~     assays during CRS and HIPEC with a follow-up of 7 days postoperative.~   "
41263|NCT03026621|"~     The purpose of this study is to determine whether or not 'Restore' lignite extract mineral~     supplement impacts the microbiome composition of the mouth and gut. Additionally, participant~     urine samples will be examined to determine whether or not 'Restore' mineral supplement~     impacts the composition urine biomarkers and toxins.~   "
40624|NCT03034980|"~     Coronary artery disease (CAD) is associated with high mortality worldwide. Narrowing of the~     coronary arteries can cause an acute myocardial infarction. Patient with cardiac ischemia are~     often treated with percutaneous coronary intervention (PCI) or coronary artery bypass~     grafting (CABG). Following hospitalisation, the patients are offered to attend a classical~     rehabilitation program with moderate exercise intensity. Current exercise program for cardiac~     rehabilitation has proven to reduce cardiovascular risk factors 1. Is it possible to improve~     the exercise capacity and risk profile even more if the exercise program includes more~     vigorous training? The program starts one week after the cardiac incident (AMI, PCI or CABG)~     and takes 12 weeks to complete. Patients with heart failure and valvular disease are~     excluded. First ventilatory threshold (VT1) and second ventilatory threshold (VT2) are~     determined during cycloerometry. VT2 reflects aerobic-anaerobic transition and therefore the~     aerobic functional capacity2. Exercise load reached at VT2 is used to determine the training~     load during rehabilitation.~      The research goal is to investigate the influence of training intensity on the exercise~     capacity and risk profile of CAD patients.~   "
40625|NCT03034967|"~     Danirixin (DNX) is a selective CXC chemokine receptor (CXCR2) antagonist being developed as a~     potential anti-inflammatory agent for the treatment of COPD. This is a Phase 2, randomized,~     double-blind (Sponsor Open) study. The primary objective of the study is to evaluate the~     clinical activity and safety of danirixin compared with placebo in participants with COPD.~     Following baseline assessments collected over a 7 day period participants will be randomized~     (1:1:1:1:1:1) to receive one of five dose strengths of danirixin (5 milligram [mg], 10 mg, 25~     mg, 35 mg and 50 mg) or placebo. Study treatment will be administered orally twice daily for~     24 weeks. Participants will continue with their standard of care inhaled medications (i.e.~     long acting bronchodilators with or without inhaled corticosteroids) while receiving study~     treatment. Follow up will continue up to 28 days post last dose. Approximately 700~     participants will be screened with a target of 540 participants completing 24 weeks of~     treatment and key study assessments.~   "
40626|NCT03034954|"~     As we age, a number of factors can reduce our cognitive (or thinking) abilities. This study~     will evaluate whether transcranial electrical stimulation (TES), which uses small amounts of~     electricity to modulate brain functioning, can improve cognitive abilities. Here, the effects~     of TES on working memory, learning, and memory, will be evaluated in a group of healthy older~     adults.~   "
40627|NCT03034941|"~     The aim of this study was to evaluate the impact of short-term weight reduction achieved with~     12-week intervention with metformin alone or in combination with liraglutide on oocyte~     maturity and embryo quality in infertile obese PCOS population.~   "
40628|NCT03034915|"~     COPD is characterized by an airflow limitation, which is not fully reversible, usually~     progressive and accompanied by chronic cough, sputum production and dyspnea, which can be a~     major cause of disability and anxiety associated with the disease. In addition, COPD is~     associated with poor health-related quality of life (HRQoL). Pharmacologic therapy is used to~     improve lung function, reduce symptoms, reduce the frequency and severity of exacerbations,~     and also to improve health status and exercise tolerance.~      This is a multi-center, randomized, double blind, double dummy, 3-arm parallel group study to~     compare umeclidinium/vilanterol (62.5/25 microgram [mcg], once daily), umeclidinium (62.5~     mcg, once daily), and salmeterol (50 mg, twice daily) in male and female subjects with COPD.~     The primary purpose of this study is to demonstrate improvements in lung function for~     subjects treated with UMEC/VI compared with UMEC for 24 weeks.~      Approximately 2424 subjects will be randomized across 3 parallel arms in 1:1:1 ratio.~     Subjects will be stratified based on long-acting bronchodilator usage during the run-in~     period (none, one or 2 long-acting bronchodilators per day). Subjects will receive either~     UMEC/VI inhalation powder (62.5/25 microgram [mcg] once daily) administered via the ELLIPTA®~     dry powder inhaler (DPI) and placebo twice daily via DISKUS® DPI; or UMEC (62.5 mcg once~     daily) administered via the ELLIPTA DPI and placebo twice daily via DISKUS DPI or salmeterol~     (50 mcg twice daily [BID]) administered via the DISKUS DPI and placebo once daily via ELLIPTA~     DPI. The duration of the study will be 29 to 31 weeks including a pre-screening period of 2~     weeks, run-in period of 4 weeks, treatment period of 24 weeks and follow-up period of 1 week.~      ELLIPTA and DISKUS are trademarks of GSK group of companies.~   "
40629|NCT03034889|"~     The infantile brain has to pass essential, mayor steps in the first 36 months of life. During~     that period of development it is particularly vulnerable to toxic, exogenic influences. This~     study wants to review the long-term effects of children who were exposed to anesthesia in the~     first three years of their life. Therefore the investigators will examine children at age of~     4-10 that were exposed to anesthesia and compare their neurocognitive capacity to children~     who did not have any exposure to anesthesia. The investigators plan on measuring the~     intelligence quotient using standardized tests which will be performed by a trained~     psychologist. In addition there will be a questionnaire concerning behavioral characteristics~     and educational development which is filled by the parents. The exposed children will be~     recruited from our preexisting database, the control group will be recruited from~     practitioners and the pediatric walk-in-clinic.~   "
40630|NCT03034876|"~     Acute Kidney Injury is common in critically ill children and is associated with high~     morbidity and mortality in pediatric intensive care unit. The serum creatinine is still a~     gold standard test for diagnosis of AKI, but it rises after 1 to 3 days of injury . However,~     Neutrophil Gelatinase-Associated Lipocalcin (NGAL) is an emerging biomarker in identifying~     AKI at an early stages, which may in future help us in promptly instituting reno-protective~     interventions like avoidance of nephrotoxic exposure and contrast agents, maintenance of~     euvolemia and perfusion pressure which will not only preventing kidney from further failing,~     decrease the use of very expensive and complicated renal supportive therapy like continuous~     renal replacement therapy (CRRT) as well as in decreasing morbidity and mortality related to~     AKI.~   "
40631|NCT03034863|"~     The management of suicide risk is a pressing national public health issue especially among~     Veterans, and there exist no guidelines of how best to involve family members in this effort.~     This proposal will integrate family and couples communication skills training with suicide~     safety planning. The goal is for the sharing of Veteran suicide safety plans with family~     members and the construction of a parallel family member safety plan, in efforts to mobilize~     and support family involvement.~   "
40633|NCT03034837|"~     Eruption of the first permanent molar is the earliest in our oral cavity, leading to a high~     occurrence of dental caries in its pits and fissures. Early prevention of pit and fissure~     caries in this tooth is therefore of great importance for the preservation of a healthy~     dentition in one's life long time.~      It has been shown that sealing the occlusal surface with pit and fissure sealant is a highly~     effective method to prevent pit and fissure caries. It has also been shown that the~     performance of sealing pits and fissures by glass ionomer materia l (the high viscosity,~     classification type 2 GIC material) using finger press method used in the atraumatic~     restoration method is as significant as that of using the traditional resin sealant material~     and technique.~      The purpose of this study is to evaluate the long-term cost-effectiveness performance of the~     two sealing materials in the prevention of pits and fissures caries in young permanent molars~     of schoolchildren in a dental public health program to be held in primary schools. The~     findings will provide valuable information for decision making on the election of proper~     material and method for use in dental public program, especially for child population in the~     rural or social-economically deprived areas.~   "
40634|NCT03034824|"~     The aim of our study is to determine the interleukin-1βeta (IL-1β), interleukin-8 (IL-8) and~     tumor necrosis factor-αlfa (Tnf-α) levels in gingival crevicular fluid (GCF) and clinical~     periodontal parameters following the treatment with~     Erbium,Chromium:Yttrium-Scandium-Gallium-Garnet (Er,Cr:YSGG) and diode lasers in adjunct to~     scaling and root planing (SRP) in patients with generalized aggressive periodontitis (GAgP).~     Twenty-six patients with GAgP (n=26) were enrolled in the study. The study was designed as a~     split-mouth study. In each patient, three quadrants were randomly determined as~     SRP-control, SRP+Er,Cr:YSGG and SRP+Diode laser. Clinical periodontal measurements were~     recorded at the baseline and third month after the treatment. Cytokines levels in GCF were~     determined by enzyme-linked immunosorbent assay (ELISA).~   "
40635|NCT03034811|"~     The primary objective of this study is to obtain implant survivorship and clinical outcomes~     data for the commercially available Persona Partial Knee System.~   "
40636|NCT03034798|"~     The purpose of the study is to determine the effects of insulin suspension at start of~     exercise in individuals with type 1 diabetes. A total of 3 sessions will be required for this~     project. The first will be a familiarization session that requires completed informed~     consent, anthropometric measurements (height, weight, body fat percentage), questionnaires,~     and a test of maximal aerobic fitness. The remaining 2 sessions will be steady-state aerobic~     exercise as well as circuit exercise.~   "
40637|NCT03034785|"~     The morbidities associated with very low birth weight (VLBW) infants constitute a major~     health problem and a significant emotional and financial burden for families and our nation.~     The key to reducing this burden is early diagnosis. This research will be the first step~     towards intervention for cerebral growth and long-term neurodevelopmental morbidities of VLBW~     infants.~      The proposed research is to design and fabricate a new technological innovation in wearable~     soft-sensors, called flexi-mitts, for measuring force modulation and joint angles of the hand~     (wrist and fingers) of toddlers. Building upon the investigators' ongoing work, they plan to~     engineer stretchable electronics for safe, toddler-scaled flexi-mitts to measure planning and~     force modulation. Additionally, the investigators plan to have the parent/guardian wear the~     gloves so they can determine the relative contributions of the child and the adult to the~     child's learning. In the same way that the adult assists learning to walk, they may assist in~     learning during play. The force data may be analyzed in the same way as the child's data.~      The investigators' new flexi-mitt technology has the potential to provide a new diagnostic~     technology and the development of clinical assessment norms. With additional trials of the~     technology in large numbers of young children, it may be possible for clinicians and day care~     providers to eventually make measurements of planning and force modulation in play settings.~   "
40638|NCT03034772|"~     A previous pilot study demonstrated that commonly available glaucoma drops~     (dorzolamide-timolol) might decrease the amount of chronic swelling in patient with wet~     age-related macular degeneration who have been receiving anti-vascular endothelial growth~     factor (VEGF) injections. This will be a larger study where subjects are randomly assigned to~     receive the glaucoma drops or a placebo (artificial tears) in order to confirm whether this~     previous finding is valid. Subjects will continue to receive the normally scheduled anti-VEGF~     injections at regular intervals as done prior to enrollment. The only addition to the regimen~     will be the daily use of eye drops (dorzolamide-timolol or artificial tears) twice daily for~     the duration of the study. At the end of the study, the swelling in the retina will be~     compared to the amount before starting the drops to see if there is any difference between~     the group using dorzolamide-timolol versus artificial tears.~   "
40639|NCT03034759|"~     We aim to test the efficacy of a new method for determining individual insulin sensitivity~     (IS) based on sensor-augmented-insulin pump (SAP) data in order to customize the insulin to~     carbohydrate ratio (CR) in adolescents with type 1 diabetes (T1D).~      To date, the individual insulin sensitivity (IS) could only be investigated by intensive and~     invasive research techniques that are not feasible to perform in an outpatient setting for~     pediatric patients with diabetes.~      Recently published studies have demonstrated the efficacy of an algorithm to calculate the~     patient specific insulin sensitivity to customize the CR for adult patients with T1D. The~     algorithm has been validated in adult patients, however not yet investigated in the pediatric~     population with T1D.~      The aims of our study are:~        1. to customize the CR of pediatric subjects with T1D using the individualized insulin~          sensitivity index (ISind) to improve post-prandial blood glucose control after a~          standard meal.~        2. to test, under free living condition (at home), the efficacy of the customized CR in~          improving post-prandial glycemic control for pediatric subjects with T1D.~      This approach would have at least two potential benefits for pediatric patients with T1D:~        1. To provide a non-invasive tool for individualizing their home insulin therapy;~        2. To offer a reliable instrument for adjusting the meal bolus of the current hybrid closed~          loop (HCL) systems to account for the inter-subject variability in insulin action.~   "
40662|NCT03034460|"~     Exploratory, multi-center, randomised, investigator-blinded, vehicle controlled study using~     intra-individual comparison involving subjects with acne vulgaris on face to evaluate the~     efficacy of CD5024 1% cream over a 6-week treatment period compared to its vehicle.~   "
40640|NCT03034746|"~     Emerging literature suggests that vascular factors might be involved in the pathogenesis of~     Alzheimer's disease (AD). Other recent studies demonstrate the positive effects of physical~     activity on cognitive and behavioral disturbances of patients with AD. Therefore, it has been~     postulated that exercise enchantment in cerebral circulation is the physiological mechanism~     that link physical exercise and reduction of AD symptoms. Consequently, a program of physical~     activity could be considered one approach to counteract dementia by improving cerebrovascular~     health.~      However at this moment, it is not clear if the progressive brain vascular dysfunction and~     hypoperfusion, associated with the β-amyloid deposition, might be reversed or stabilized by~     an exercise intervention.~      The aim of this study is to assess, in patients with AD, the influence of physical exercise,~     compared to cognitive stimulation, on:~        -  Cognitive function;~        -  Independence in daily living and behavioral symptoms;~        -  Vascular function Finally, to investigate the physiological processes on the basis of~          the motor parameters' changes, the performances of the patients will be compared with~          the performances of healthy young and old subjects.~      MAIN OBJECTIVE: Investigate, in patients with Mild Cognitive Impairment (MCI) and AD, the~     effects of a physical activity program, or cognitive stimulation on global cognitive~     function.~      SECONDARY OBJECTIVES: Investigate the effects of the two treatments on:~        -  cognitive and motor performances,~        -  independence in activities of daily living,~        -  behavioral symptoms,~        -  peripheral vascular function.~   "
40641|NCT03034733|"~     The purpose of this study is to examine, if a single-dose of dexamethasone given during the~     operation, alleviates pain after knee replacement surgery.~   "
40642|NCT03034720|"~     SPECIFIC AIMS~      While post-concussive symptoms following sports-related concussion are typically transient~     and resolve spontaneously within two weeks of concussive injury, 14% or more of youth who~     sustain concussion experience significant morbidity that can persist well beyond the normal~     disease course.Furthermore, post-concussive symptoms commonly co-occur with affective~     symptoms including depression and anxiety which when present can prolong recovery from~     primary post-concussive symptoms. Together, persistent physical and psychological symptoms~     confer protracted functional impairment and create a significant burden for affected youth,~     their family, and school. Currently, there are no evidence-based guidelines to inform~     treatment of persistent post-concussive symptoms in youth and adolescents.~      In response to the dearth of evidence-based treatment approaches for youth with persistent~     post-concussive symptoms, the investigators developed a novel collaborative care treatment~     model that simultaneously targets post-concussive symptoms and co-occurring depression and~     anxiety. Athletes and their family members receive patient navigator care management services~     that bridge post-injury care across acute care, specialist and primary care health service~     delivery sectors, in addition to cognitive behavioral psychotherapy. Patients who remain~     symptomatic after initial treatment efforts receive stepped-up care that may include~     psychopharmacologic consultation. The Investigators have demonstrated feasibility of the~     intervention model through a pilot randomized-control trial of 49 adolescents with persistent~     post-concussive symptoms recruited from a regional children's hospital. Participants assigned~     to the intervention condition demonstrated significant and clinically-meaningful reductions~     in post-concussive and depressive symptoms as well as health-related quality of life as~     compared to adolescents in the usual care arm of the trial.~      The proposed study will expand upon the pilot trial in order to further develop, implement,~     and test the impact of an innovative collaborative care approach tailored to the needs of a~     patient population who currently have no evidence-based options. The investigators propose a~     broad reach intervention strategy that is designed to be readily implemented in acute,~     specialty and primary care medical settings, as well as over the telephone. The investigators~     will conduct a randomized comparative effectiveness trial with 200 youth, ages 11-18,~     suffering from ≥ 3 post-concussive symptoms at least 1 month after their sports-related~     injury. Athletes will be randomized to collaborative care (intervention) or post-sports~     injury care as usual (control group) conditions. The study is designed with the following~     aims:~      Aim 1. To determine the effectiveness of a stepped-collaborative care intervention model in~     reducing post-concussive and co-occurring psychological symptoms in youth with persistent~     post-concussive symptoms after sports-related concussion H1: Youth receiving a collaborative~     care intervention will demonstrate clinically and statistically significant reductions in~     post-concussive symptoms, depressive and anxiety symptoms over the course of the 12-month~     study, compared to usual care control group athletes Aim 2. To examine the effectiveness of~     the intervention in improving function and health-related quality of life amongst youth with~     persistent symptoms after sports-related concussion H2: Adolescents who receive a~     collaborative care intervention will exhibit a clinically meaningful improvement in function~     and health-related quality life Exploratory Aim 3. To explore differences in school~     performance between groups H3: Adolescents who receive the collaborative care intervention~     will receive individualized treatment and community resource linkages which will improve~     their school performance as compared to adolescents receiving treatment as usual~      IMPACT: By broadly targeting the constellation of post-concussive physical and psychological~     symptoms and integrating care amongst primary care, pediatric sub-specialist, and behavioral~     health providers, the collaborative care health services intervention could accelerate the~     rate of recovery from persistent post-concussive symptoms and attenuate the degree and~     duration of disability during adolescence, a critical period for healthy development.~     Validation of this treatment through a scaled up clinical trial will serve as a foundation~     for broader dissemination of this collaborative care treatment model. The multidisciplinary~     sports concussion research team will simultaneously work nationally and internationally to~     ensure study results are expediently translated into effective policy for youth athletes~     suffering from enduring symptoms and functional impairments in the wake of sports-related~     concussions.~   "
40643|NCT03034707|"~     The B vitamin biotin is widely available as an over the counter supplement, often advertised~     and used to promote health of hair, skin and nails. Commercially available over the counter~     biotin supplements contain dose ranges up to 10 mg/day (ie 333 times higher than the~     recommended dietary allowance). The biotin molecule is also sometimes used as part of the lab~     technology to measure hormone and protein levels in the blood. It is possible that high doses~     of ingested biotin may interfere with accurate hormone or protein measurement using biotin~     related in vitro measurement systems. Such interference, if present, could lead to~     misdiagnosis. The study will analyze laboratory levels obtained with streptavidin-biotin~     assay systems while ingesting biotin in currently available high dose supplements. The data~     will be compared to measurements obtained prior to and one week after stopping the biotin~     supplement.~   "
40644|NCT03034694|"~     The effect of teledermatology on length of hospital admission, length of stay, 30 day~     readmission rate, and antibiotic use in patients presenting with cellulitis vs~     pseudocellulitis in an academic emergency department setting.~   "
40645|NCT03034681|"~     This pilot pre-post quasi-experimental study evaluates for the first time the effectiveness~     of Vojta Therapy in treating lumbosciatic and compares it with the transcutaneous electrical~     nerve stimulation (TENS) procedure. Patients who agree will be distributed alternately in~     order of arrival to a Physiotherapy Unit, in such a way that half of the sample will be~     treated using TENS and the other half with Vojta.~   "
40646|NCT03034668|"~     Purpose: To evaluate the acute and chronic effects of a botanical supplement on strength,~     muscle function, and lean body mass~      Participants: The acute phase will include 30 participants, and the chronic phase will~     include 84 participants. All participants must be healthy recreationally active males between~     the ages of 18 and 35 years.~      Procedures (methods):~      Acute phase: Participants will complete three testing visits as part of as part of a~     cross-over design, during which strength and muscle function will be assessed prior to and~     following consumption of a supplement. The experimental supplement is a blend of the~     botanical extracts; treatment arms will include a full dose (FULL; 350 mg capsule), half dose~     (HALF; 175 mg plus maltodextrin), or placebo (PLA; maltodextrin).~      Chronic phase: Body composition, muscle cross-sectional area, a complete blood count and~     metabolic panel, subjective surveys, and strength will be measured prior to and following an~     8-week supervised resistance training program, in conjunction with daily supplementation of~     FULL, HALF, or PLA.~   "
40647|NCT03034655|"~     The aim of this study is to evaluate and compare the effectiveness of vestibular~     rehabilitation developed using computerized dynamic posturography or a mobile posturographic~     system with vibrotactile stimulation, to improve the balance in older people and reduce the~     number of falls.~   "
40648|NCT03034642|"~     The long-term goals of this study are (a) to understand the biological underpinnings for the~     increased incidence of community-acquired pneumonia in patients with chronic obstructive~     pulmonary disease (COPD) who are treated with inhaled corticosteroids; and (b) to develop~     novel therapies to treated this problem using over-expression of micro-RNAs (miRNAs).~   "
40649|NCT03034629|"~     The overall goal of this proposed study is to assess the reliability of plasticity measured~     by transcranial magnetic stimulation (TMS) interleaved with intermittent theta-burst~     stimulation plasticity measures and to assess the influence of an acute bout of aerobic~     exercise on TMS plasticity measures.~   "
40650|NCT03034616|"~     The OLIVA device will enable to perform shallow slashes on the ovarian cortex in patients~     undergoing oophorectomy. Prior to the resection of the ovary from the pedicle we will perform~     5 parallel slashes 3 cm long. following oophorectomy investigation by the pathologist as to~     the depth of cuts and proximity to blood vessels and later.~   "
40651|NCT03034603|"~     This triple-blinded randomized placebo control trial aims to investigate the safety and~     efficacy of Nutri-PEITC jelly, a functional food, in head and neck cancer patients. The~     primary outcome measure includes adverse events and health-related quality of life. The~     secondary outcome includes tumor response and functional status.~   "
40652|NCT03034590|"~     This study will translate an English case definition of poststroke fatigue and validate it~     against the Multidimensional Fatigue Questionnaire-20 and the Fatigue Severity Scale~   "
40687|NCT03034135|"~     This study of DSF-Cu in combination with TMZ for recurrent GBM will evaluate the antitumor~     effect in patients who have recurrent GBM. Patients will take DSF-Cu daily during their~     routine standard of care with TMZ therapy for approximately 6 months. Patients will be~     evaluated for response every 8 weeks. Patients will be followed up 2 years after the last~     dose of DSF-Cu.~   "
40688|NCT03034122|"~     The aim of the study is to establish if caffeine consumption is associated with the evolution~     of the disease in premanifest HD.~   "
40653|NCT03034577|"~     Trial summary: deep neuromuscular block is proposed as a technique to improve operative~     conditions for laparoscopy. Early clinical data would suggest that there may also be patient~     benefits beyond the operative period related to lower intra-abdominal pressure, and improved~     surgical exposure. In order to safely conduct deep neuromuscular blockade, it is essential to~     use Sugammadex to reverse the neuromuscular block. Conventional practice is to provide~     moderate neuromuscular block and reverse with neostigmine. It is not possible to safely~     reverse deep neuromuscular block using neostogmine, as the majority of block must have worn~     off for neostigmine to be effective. in order to identify whether deep neuromuscular block~     improves quality of recovery after surgery, the investigators will conduct a randomised trial~     of deep versus moderate neuromuscular block, whilst minimising variance in other anaesthetic~     techniques and drugs used. the outcome measured will be the post-operative quality of~     recovery over multiple time periods using the Postoperative Quality of Recovery Scale~     (PostopQRS). 350 patients will be enrolled over 4 centres.~   "
40654|NCT03034564|"~     This is a randomized, double-blind, placebo-controlled trial comparing droxidopa to placebo~     for fatigue in Parkinson's Disease. The primary outcome measure is change in the Parkinson's~     Disease Fatigue Scale, a 16-item scale that measures the physical effects of fatigue as well~     as the impact of fatigue on daily functioning and activities, including socialization.~     Secondary outcomes are the PDQ-39, a 39-item self-report questionnaire assessing Parkinson's~     disease-specific health related quality over the last month in 8 different dimensions of~     function and well-being, and the Epworth Sleepiness Scale, a questionnaire querying 8~     situations for which the subject will rate the likelihood of falling asleep. There will be a~     screening visit (SC), baseline visit (BL), 2 clinic visits at 6 and 12 weeks (V01, V02), and~     telephone contact at 4 weeks and 8 weeks (T1, T2). In-person visits will include review of~     informed consent, concomitant medication review, adverse event review, pill counts, vital~     signs (including supine blood pressure), and outcome measurements. Telephone visits will~     include review of informed consent, concomitant medication review, and adverse event review.~   "
40655|NCT03034551|"~     The goal of this study is to test the efficacy of a financial incentives-based telehealth~     intervention to reduce 30- and 90-day heart failure (HF) readmissions by tracking and~     increasing adherence to patient self-care - specifically by incentivizing adherence to~     prescribed cardiac medication regimen and daily self-weighing. Patients randomized to the~     treatment arm will be given a cellular-connected scale to use at home, as well as a mobile~     app on their smartphone that tracks their adherence to daily self-weighing through the scale~     and cardiac medications via patient photo submission. The health care team will intervene if~     a sudden increase in weight is detected (2 lbs/day or 5 lbs/week). Financial incentives of~     $150 are offered for full adherence over 90 days. Each day where the patient does not step on~     the scale and complete a medication check-in will result in a deduction of $2 per day from~     the incentive amount to be paid out. The control group will receive the usual discharge~     instructions as prescribed by their health care team.~   "
40656|NCT03034538|"~     In this 12-week, open-label pilot study, the investigators will enroll 20 subjects with~     Parkinson's Disease to determine if two doses of Zonisamide are tolerable and demonstrate~     clinical benefit for Dyskinesias. The primary outcome measure is tolerability, as determined~     by number of subjects able to complete the study on their originally assigned dosage.~     Secondary outcome measures will use the Unified Dyskinesia Rating Scale (UDysRS), comprised~     of an Objective Section and a Historical Section, to compare baseline to 6 and 12-week~     measurements. Additional analysis of the effect of Zonisamide on quality of life will be~     measured by the Parkinson's Disease Quality of Life Questionnaire (PDQ-39).~   "
40657|NCT03034525|"~     Acute pulmonary embolism (APE) is a common disease, which involves significant morbidity and~     mortality. The clinical presentation of APE has many faces but it is acceptable to suspect~     this disease when the patient presenting with at least one of the following: shortness of~     breath, pleuritic chest pain, cough, sub-febrile fever or hemoptysis.~      The relationship between syncope and APE is not entirely clear. Prandoni et al conducted a~     systematic process for the exclusion / confirmation of APE all patients hospitalized for a~     first investigation of syncope. In this study APE was diagnosed in about 17% of the patients.~     In 12.7% of patients with an alternative explanation for syncope APE was diagnosed.~     Interestingly, 25% of the patients had no other manifestation of pulmonary embolism apart~     from the syncope itself.~      According to the updated clinical guidelines, APE should not be routinely tested as an~     etiology for syncope and not systematically excluded. According to the new data presented by~     Prandoni et al, this means that a significant percentage of patients hospitalized for an~     investigation of syncope are discharged when they are suffering from APE (in most cases~     probably an event of unprovoked pulmonary embolism) without treatment with anticoagulants,~     making them particularly prone to PE recurrence.~      Aim. To examine the incidence of pulmonary embolism (Pulmonary Embolism, PE), and VTE (venous~     thromboembolism, VTE) in patients hospitalized for a first investigation of syncope.~   "
40658|NCT03034512|"~     This is a natural history study of Alpers Huttenlocher Syndrome. Patients will be followed~     over time to assess clinical symptoms for the purpose of expanding knowledge of this disorder~     in the medical community.~   "
40659|NCT03034499|"~     A prospective randomized controlled study intended to compare the efficacy of 2 methods of~     robotic assisted sacrocolpopexy for the repair of vaginal apex prolapse:~        1. Via single-port.~        2. Via multi-port.~   "
40660|NCT03034486|"~     This study is a single sequence, 3-period, multiple-dose study to evaluate the~     pharmacokinetics of D565 and the drug effect of D565 on pharmacokinetic characteristics of~     D930 in healthy male volunteers.~   "
40661|NCT03034473|"~     The objective of the TransValid-KFO179/GRCSG-Trial-A is the validation of potential~     biomarkers. These are predictive (Prediction of probability of response to a certain therapy)~     / prognostic (predicting long-term outcome) microarray-based gene expression signatures and~     immunohistochemically evaluated biomarkers. The evaluation was done within the KFO179~     (www.kfo179.de) - the validation is implemented in this trial.~      Therefore tumor material of patients undergoing standard radiochemotherapy will be analyzed~     from pretreatment biopsies an residual tissue from the resection specimen after surgery. This~     validation and the biomaterial asservation will be incorporated into clinical routine in all~     participating centers as a model for the treatment of solid tumors. The obtained biomarkers~     with a predictive and prognostic power will be used to develop an algorithm to predict~     patients at high risk of local and distant cancer recurrence.~   "
40663|NCT03034447|"~     Asthma and sleep apnea are both respiratory diseases and one can worsen the other. Those who~     suffer from asthma have a higher risk of sleep apnea and sleep apnea can make the asthma more~     difficult to control.~      As girls usually have a more severe asthma than boys, the investigators believe that girls~     have a higher risk of sleep apnea.~      To test if asthmatic girls have more sleep apnea than boys, the investigators are going to~     ask them questions regarding asthma and sleep symptoms (such as snore) and the investigators~     are going test the lung function and how many times they stop breathing during the sleep. The~     sleep test is going to be performed in children's home.~      In children, having sleep apnea can make the asthmatic stay in the hospital 30% more when~     they have an asthma attack. We also are going to look if sleep apnea increases the number of~     hospitalizations and asthma attacks in the past 12 months.~   "
40664|NCT03034434|"~     Patients after vaginal delivery will undergo 3 trans-vaginal ultrasounds in order to examine~     the process of cervical recuperation post delivery.~   "
40665|NCT03034421|"~     Endoscopic valve therapy is an effective therapy for patients with severe emphysema and low~     interlobar collateral ventilation. Although, valve therapy is a minimal-invasive treatment~     approach, it is associated with complications the most common of which is pneumothorax with a~     rate of 18-25%. Modifying post-operative medical care including bed rest for 48 hours after~     valve implantation may reduce the risk of post-interventional pneumothorax.~   "
40666|NCT03034408|"~     Impulsivity is a central feature of addiction. Nalmefen is an authorized treatment for~     alcohol addiction. Baclofen has empathically been advocated to have some efficacy in this~     indication. The aim of the present study is to test the effect of Nalmefene and Baclofen on~     impulsivity.~      Primary study objective: To examine the effect of Nalmefene and Baclofen on impulsivity (as~     measured by the Stop Signal Task) in subjects with alcohol use disorder and healthy control~     subjects.~      Main secondary study objectives: To examine the effect of Nalmefene and Baclofen on risk~     taking (as measured by the Balloon Analogue Risk Task) and on the preference for small~     immediate rewards over large delayed rewards (as measured by the Delay Discounting Task). To~     compare subjects with alcohol use disorder and healthy control subjects on these tasks.~      Primary study outcome: Stop-signal reaction time in the Stop-Signal Task Main secondary study~     outcomes: Equivalence point in the Delay-Discounting Task and Average number of pumps~     delivered in the Balloon Analogue Risk Task~      Study Design: Randomized, placebo control, cross-over, single-dose~   "
40667|NCT03034395|"~     This is a randomized non-blinded pilot study for patients with melanoma staging cT2N0M0 who~     are candidates for surgical resection. The primary objective is to determine the feasibility~     of randomizing participants with cT2N0M0 malignant melanoma to surgical treatment with 1cm~     versus 2cm margins. Study will try to determine overall survival for cT2N0M0 malignant~     melanoma after surgical treatment with 1cm versus 2cm margins.~   "
40668|NCT03034382|"~     the aim of this study is to evaluate the duration of analgesia when either morphine or~     nalbuphine or both are used as adjuvants in sonar guided interscalene brachial plexus block~     for arthroscopic rotator cuff repair.~   "
40669|NCT03034369|"~     The goal of this study is to identify outcomes associated with Behavioral Health Integration~     (BHI) that matter to patients, to compare changes in outcome over time to measure the impact~     of different BHI models on different patients, and to create and maintain an Integration~     Learning Collaborative.~   "
40670|NCT03034356|"~     This study plans to learn more about the effects of levetiracetam (LEV) on brain activity and~     cognition in schizophrenia and schizoaffective disorder. Levetiracetam is an anti-seizure~     drug, also called an anticonvulsant.~   "
40671|NCT03034343|"~     The aim of this study is to assess and compare a mindfulness low-intensity (4 weeks)~     psychological intervention for the treatment of depression in Primary Care between different~     groups: a mindfulness intervention applied face to face in group format, a control group that~     will receive treatment as usual (TAU) consisting of medical treatment and the same~     mindfulness intervention applied by Information and Communication Technologies (ICTs). The~     principal hypothesis is that face to face intervention will be more effective than TAU~   "
40672|NCT03034330|"~     This study intends to develop a family-based care management intervention with primary aims~     to provide time-limited support for family caregivers affected by stroke and to empower~     caregivers through enhancing the family adaptation and functioning and increasing their~     capacity of stroke care. The objectives include:~        1. To examine the effectiveness of the proposed family-based intervention to improve~          family, caregiver, and service outcome.~        2. To examine the cost-effectiveness of the proposed family intervention.~      It is hypothesized that comparing to the control group, the experimental group participants~     will have more and significant outcome.~   "
40673|NCT03034317|"~     The purpose of this research study is to collect more information about the use, safety, and~     effectiveness of the NeuRx DPS® in ALS patients.~   "
40674|NCT03034304|"~     The purpose of this study is to determine whether the MASCT-I alone and in combination with~     chemotherapy drug are safe and effective in the treatment of advanced bladder cancer and soft~     tissue sarcoma~   "
40689|NCT03034109|"~     The purpose of this study is to test the effects of tDCS (Transcranial Direct Current~     Stimulation) on stroke patients with working memory problems.~   "
40690|NCT03034096|"~     This is a large pragmatic multicenter trial comparing maintenance of general anesthesia with~     total intravenous anesthesia using propofol versus volatile agent (sevoflurane, isoflurane,~     or desflurane) during cancer surgery. The primary endpoint is all-cause mortality.~   "
40691|NCT03034083|"~     The purpose of this study is to determine whether the healthy marriage and relationship~     education program Elevate: Taking Your Relationship to the Next Level results in improved~     couple, parenting, and co-parenting behaviors that lead to reduced child abuse/neglect~     potential.~   "
40692|NCT03034070|"~     This study will assess and compare the diagnostic performances and image quality of two WB 3D~     T1-weighted MR imaging sequences for bone and node staging in patients with prostate cancer :~     the FSE sequence and a gradient echo (GE) sequence. The latter sequence's main feature is its~     acquisition time of approximately 1.5 minutes, compared to 18 min for the FSE sequence,~     reducing the exam's acquisition time, patient discomfort and increasing machine availability.~   "
40693|NCT03034057|"~     A one-year evaluation of Sayana Press self injection in women of reproductive age in the~     United Kingdom (UK).~   "
40675|NCT03034291|"~     Metabolic syndrome (MS) is a clinical entity that includes several disorders that predispose~     to imbalance in lipid metabolism: hypertension, insulin resistance, hypertriglyceridemia,~     obesity and low levels of high density lipoprotein. The SM itself has a great impact on~     morbidity and mortality and is also related to increased cerebrovascular risk and Diabetes~     Mellitus 2 (DM2). In Colombia, DM2 is one of the 10 leading causes of illness and death in~     people over 45 years. It is accepted that insulin resistance is a stage that precedes the~     onset of DM2, but there are few alternatives to reverse it or prevent its progression to~     diabetes.~      The control of insulin resistance requires increased physical activity, reduced body weight~     and changes in eating patterns, measures that are not easily adopted in modern Western~     society.~      There is evidence of the effect of chocolate consumption on increasing insulin sensitivity in~     both hypertensive diabetic patients as well as in normal individuals, apparently because of~     the ability of cocoa polyphenols to increase the bioavailability of nitric oxide, Formation~     of reactive species of oxine, optimizing carbohydrate metabolism and modulating~     insulin-related cellular signaling events.~      A prospective, double-blind, placebo-controlled, double-blind clinical trial evaluating the~     effect of 50 g of chocolate with 70% cocoa solids, which contributes at least 430 mg of~     polyphenols, is conducted for 8 weeks in The reduction of insulin resistance defined by the~     reduction of the HOMA-IR index. In addition, there was an increase in arterial reactivity in~     non-diabetic individuals with central obesity and insulin resistance. Likewise, to infer the~     effect of this food intervention in the modification of the total cardiometabolic risk of the~     participants.~   "
40676|NCT03034278|"~     The primary objective of this study is to better understand post-discharge utilization of~     prescribed opioid analgesic medications following surgery. A secondary objective of this~     study is to gain a better understanding of prevailing modes of storage for opioid~     medications.~   "
40677|NCT03034265|"~     The purpose of this study is to determine the concentrations and variabilities of urinary~     exosomal sodium channels and plasma angiotensins in patients with difficult-to-treat arterial~     hypertension and to investigate their dependency on clinical parameters and sampling~     conditions.~   "
40678|NCT03034252|"~     Retrospective Evaluation of Survival after Liposarcoma~   "
40679|NCT03034239|"~     Purpose: to study the effect of insect protein on performance and hypertrophy during 8 weeks~     of resistance training.~      Hypothesis: Insect protein supplementation enhances the effect of resistance training on~     muscle mass and muscle strength.~      Primary outcome: Muscle hypertrophy and muscle strength~      Design: Two groups of healthy young men (age: 18-30 years) with resistance training~     experience, but no structural resistance training performed for the last 12 months.~     Randomized controlled intervention study +/- insect protein (placebo group ingest isocaloric~     carbohydrate). Both groups perform 8 weeks of progressive resistance training (4/week) aiming~     to induce muscle hypertrophy.~   "
40680|NCT03034226|"~     This study compares the hypoglycemic counter regulatory response in type 1 diabetics and in~     healthy control subjects with and without antecedent hypoglycemia~   "
40681|NCT03034213|"~     The hypothesis for this study is complex incisional hernia repair using the separation of~     components technique reinforced with retrorectus placement of Gentrix™ Surgical Matrix will~     lead to fewer incisional hernia recurrences and fewer wound complications compared to the~     same incisional hernia repair techniques reinforced with other prosthetic or~     biologically-derived mesh.~   "
40682|NCT03034200|"~     The purpose of this study is to learn if a new drug, ONC201 can make tumors become smaller or~     go away completely. Investigators also want to learn if ONC201 can prevent new deposits of~     cancer from appearing in new places in participants (metastases). A phase 2 study of ONC201~     in PC-PG (pheochromocytoma-paraganglioma) and other neuroendocrine tumors will determine~     whether inhibition of DRD2 (a member of the dopamine receptor family) is safe in~     neuroendocrine cancers including PC-PG.~      ONC201 is an investigational (experimental) agent and has a favorable safety profile in phase~     1 and early phase 2 clinical trials in advanced cancers. This study design has been chosen to~     see whether ONC201 is associated with reduction of anti-hypertension medications, safety and~     significant efficacy against neuroendocrine tumors, especially PC-PG.~   "
40683|NCT03034187|"~     The goal is to gain insight in the development and course of the toxicity after a curative~     treatment of prostate cancer~   "
40684|NCT03034174|"~     The objective of this study is to describe the pharmacokinetics of tigecycline in critically~     ill patients receiving continuous venovenous haemodialysis (CVVHD) and to evaluate the~     frequency of pharmacokinetic/pharmacodynamic target attainment with high dosing strategy (200~     mg loading dose and 100 mg/12h).~   "
40685|NCT03034161|"~     40 patients total with pressure ulcers with a decubitus pressure ulcer will be included in~     this study. Ten patients with a Stage I, II, III, and IV decubitus pressure ulcer will be~     included to be analyzed with a thermal imaging camera. Thermal imaging of the various stages~     of pressure ulcer will be analyzed to determine if a recognizable pattern of thermal~     distribution can be identified which can then be applied to identify patients at risk of~     developing pressure ulcers at an earlier stage in their hospital course.~   "
40686|NCT03034148|"~     In human purified platelets, only thrombin, and not the other platelet agonists, leads to a~     transient activation of the protein kinase activated by AMP (AMPK) and to phosphorylation of~     its bona fide substrate, ACC on its Ser79. ACC phosphorylation (P-ACC) can be an~     interesting marker of thrombin action on platelets. Indeed platelet and coagulation~     interplay, though undoubtedly present in atherosclerosis and atherothrombosis, remains~     difficult to assess. Our group showed that atherosclerotic mice (SRBI/Apolipoprotein E~     knock-out) had higher platelet P-ACC compared to corresponding control mice (C57BL6). In~     agreement with these data, preliminary results showed increased platelet P-ACC in a small~     cohort of patients admitted for coronary angiogram, with demonstrated coronary artery disease~     (CAD).~      In the light of our preliminary results, we sought to analyze platelet P-ACC in a large~     prospective clinical trial (ACCTHEROMA) in patients admitted for coronary angiogram. The aim~     of the study is to compare platelet P-ACC in platelets of patients with CAD and more~     particularly in unstable CAD patients to non-CAD patients. This study could potentially~     identify patients at high risk of future ischemic cardiovascular events, because of a higher~     level of thrombin generation.~   "
40694|NCT03034044|"~     This study aims to observe the safety and efficacy of the Xyntha Solofuse prefilled syringe~     in the setting of routine practice. The primary objective is to detect medically significant~     events (factor VIII inhibitor). The secondary objective is to observe the overall efficacy~     and safety of the Xyntha Solofuse prefilled syringe including serious adverse events. In this~     open-label, non-comparative, observational, non-interventional, retrospective and~     multi-center study, post-marketing surveillance data will be collected retrospectively for up~     to 6 months from the initial administration day of the Xyntha Solofuse prefilled syringe~     injected into patients who have been administered the Xyntha Solofuse prefilled syringe.~      As specified in the product approval issued by the Ministry of Food and Drug Safety, the~     study will be conducted for 4 years from the approval date. At least 600 study subjects will~     be enrolled in this study to meet the MFDS requirements. Although 600 is the assigned number~     of study subjects, the number of cases will be adjusted considering the actual number of~     enrolled subjects after the study start day.~   "
40695|NCT03034031|"~     This project will combine the data collected from structural and functional MRI scans and~     neuropsychology performance post-TBI in children. Patients will be followed for a year, in~     order to examine the brain and cognitive recovery post head injury.~   "
40696|NCT03034018|"~     The aim of this study is to determine the effect of suvorexant on insomnia symptoms in peri-~     and postmenopausal women who are experiencing sleep difficulties related to nighttime hot~     flashes.~   "
40697|NCT03034005|"~     This study aims to assess the effect of inhaled corticosteroids (ICS) on airway smooth muscle~     (ASM) Na+, K+ pumps in patients with asthma.We wish to investigate differences in Na+, K+~     pump content in healthy versus asthmatic patients, whether a reduction in airway~     hyper-responsiveness observed in asthmatic patients treated with ICS is attributable to an~     increase in Na+, K+ pump content in ASM cells and compare this in patients with~     non-eosinophilic asthma versus eosinophilic asthma.~   "
40698|NCT03033992|"~     This feasibility trial studies how well the Optune device works in treating younger patients~     with recurrent/refractory/progressive supratentorial malignant glioma and ependymoma. The~     TTFields generated by Optune device may inhibit the growth of tumor.~   "
40699|NCT03033979|"~     The investigators conclude that use of the LMA ProSealTM for prolonged procedures is~     feasible. In principle, it should be safer and more effective than the LMA ClassicTM provided~     basic guidelines are followed.~   "
40700|NCT03033966|"~     Cerebral hypoperfusion and hypoxia are the major determinants of neurological outcomes~     following acute brain injury as proved in Traumatic Brain Injury/Sub Arachnoid Haemhorrhage~     literature. How the brain injury affects cerebral oxygenation in patients with CVT is not~     currently known. Some of the factors that can affect cerebral oxygenation in patients with~     CVT are Hemoglobin, PO2, PCO2, Cerebral Perfusion Pressure (or MAP) and change in~     Intracranial Pressure after Decompressive Craniectomy. This study is designed to study how~     these factors affect cerebral oxygenation and impact of Decompressive Craniectomy on the~     cerebral oxygenation.~   "
40701|NCT03033953|"~     The aim of this study is to investigate the long term adaptations to 11 (elderly) or 12~     (young) weeks of strength training when supplemented with native whey or milk. The~     investigators hypothesize that native whey will give greater increases in muscle hypertrophy~     and strength than milk.~   "
40702|NCT03033940|"~     The primary objective is to quantify and compare the three-dimensional kinematics of the~     cruciate retaining (CR), fixed bearing ATTUNETM TKA to the kinematics of the PFC Sigma Curved~     CR Fixed Bearing TKA (both DePuy Synthes, Johnson and Johnson) during daily activities.~      The secondary objective is to describe the kinematics in terms of range of motion, patterns~     of anterior-posterior motion of the nearest medial and lateral points (posterior femoral~     rollback) and tibio-femoral internal/external rotation as well as the kinetics during daily~     activities, such as level gait, a deep knee bend (only ATTUNETM subjects), sitting down onto~     a chair, standing up from a chair and stair descent by means of video-fluoroscopy.~      Furthermore, the encoded data will be handed over to DePuy Synthes (Johnson and Johnson) and~     to the Center for Orthopaedic Engineering of the University of Denver, where it will be used~     within a musculoskeletal model with the aim of simulating tibiofemoral contact mechanics and~     changes in the musculoskeletal system due to the TKA.~   "
40703|NCT03033927|"~     The purpose of this phase II study is to develop a test to predict response of pancreatic~     cancer to different chemotherapy regimens.~   "
40704|NCT03033914|"~     The aim of this study is to improve the chance of cure for people with higher risk Hodgkin~     lymphoma. The purpose of the Phase I study is to test any good and bad effects of the study~     drug called Nivolumab when combined with ABVD for the front-line treatment of HL.The purpose~     of this Phase II study is to test whether including nivolumab in treatment for untreated~     Hodgkin lymphoma can improve the chance of cure for patients with abnormal PET scans after 2~     cycles of ABVD.~   "
40705|NCT03033901|"~     Background: Sleep disorders, including sleep apnea, are common after traumatic brain injury~     and affect recovery and negatively influence participation in rehabilitation. Sleep apnea is~     a breathing problem while persons sleep and causes further brain damage and problems with~     thinking, daily functioning, and overall health. Earlier diagnosis and treatment is important~     for TBI survivors to maximize the recovery process. There is little information that guides~     TBI doctors on how to identify sleep apnea during inpatient TBI rehabilitation, a phase in~     which people experience the potential for a rapid pace of improvement. The Agency for~     Healthcare Research has highlighted gaps in best methods for identifying sleep apnea and~     separately in helping consumers with TBI rehabilitation choices. Partnering with survivors,~     caregivers, and administrators, investigators developed this study to compare sleep apnea~     screening and diagnostic tools in TBI rehabilitation settings. This information will provide~     clinicians, providers, and patients with the best information for early identification of~     sleep apnea to remove negative influence on the pace of recovery in early phases after TBI.~      The Goal: Investigators will compare existing screening (Aim 1) and diagnostic tools (Aim 2)~     in TBI patients undergoing inpatient rehabilitation. For the second aim, investigators will~     determine if a more accessible diagnostic test is sufficient to diagnose sleep apnea compared~     to the traditional method used which is less accessible to consumers. If the more accessible~     test is good enough, this will increase recognition of this problem and increase patient~     access to earlier sleep apnea treatment.~      Stakeholders and Products. TBI survivors, caregivers, researchers, and policymakers working~     together on this study helped develop the study questions. Idea exchanges included ways to~     reach clinicians and TBI survivors/caregivers via existing educational programming and online~     tools for consumers such as fact sheets and patient/caregiver-focused videos. Other~     traditional methods will include targeting professional magazines, conferences, and research~     journals that reach professionals working with TBI survivors and their families at the time~     of admission to rehabilitation and during the recovery process. This study will occur at~     rehabilitation hospitals around the country who enroll TBI survivors into a lifetime study~     called the TBI Model System funded by the Dept. of Health and Human Services and VA.~   "
41264|NCT03026608|"~     The Green Car Evaluation was designed to test the impact of the Veggie Van mobile produce~     market on access to healthy food and fruit and vegetable intake in 12 lower-income~     communities using a cluster-randomized design.~   "
40706|NCT03033888|"~     The long-term goal is to build a sustainable, community-based outreach program to promote~     cervical cancer screening among women living with HIV (WLH), thereby reducing related~     morbidity and mortality. The strategy for achieving this goal is to develop an intervention~     incorporating health literacy approaches and principles of community-based participatory~     research. Health literacy is a relatively new concept that has been applied mainly toward~     identifying high-risk individuals rather than toward changing health behaviors and outcomes.~     The proposed intervention is the first to integrate health literacy into educating WLH to~     promote cervical cancer screening. Community Health Workers (CHW) support has also rarely~     been incorporated into cancer screening interventions targeting WLH, making the proposed~     intervention a uniquely comprehensive approach. Building on recent successful testing by the~     investigators of a health literacy-focused intervention to promote cervical cancer screening~     in recent immigrant women, the investigators will test whether health literacy-focused~     interventions delivered by trained CHWs will be effective in promoting health literacy and~     increasing Pap test rates in a new population, WLH. The investigators hypothesize that,~     compared to WLH in the control group, WLH who receive the health literacy-focused CHW~     intervention will demonstrate: (1) higher rates of Pap test, (2) greater levels of health~     literacy, (3) higher levels of cervical cancer knowledge, and (4) higher self-efficacy.~   "
40707|NCT03033875|"~     The purpose of this study is to test the psychoeducational program Tele-Savvy. Tele-Savvy~     is an internet based, group education program developed from an in person program called~     Savvy Caregiver. Participants will be randomly assigned to either the Tele-Savvy group~     (receiving only the Tele-Savvy education) or the Healthy Living Education Program (receiving~     healthy lifestyle education and then Tele-Savvy education 6 months later). Each program takes~     43 days to complete.~   "
40708|NCT03033862|"~     Platelet activation and aggregation, intrinsic thrombogenicity, and biomarkers (fibrinogen,~     C-reactive protein, platelet endothelial cell adhesion molecule, von Willebrand factor,~     p-selectin) will be measured and compared following the implantation of Bioreabsorbable~     Vascular Scaffolds and Drug Eluting Stents.~   "
40709|NCT03033849|"~     The user performance evaluation shows whether people with diabetes are able to obtain~     accurate measurement results with a blood glucose monitoring system. In this study, user~     performance evaluation will be performed for Contour® Next One (Ascensia Diabetes Care GmbH),~     Accu-Chek® Aviva Connect (Roche Diabetes Care GmbH), FreeStyle Freedom Lite (Abbott Diabetes~     Care Inc.), OneTouch® Verio (LifeScan Europe) and GlucoMen® areo A. Menarini Diagnostics~     S.r.l. (based on ISO 15197:2013; EN ISO 15197:2015, clause 8.~      For each BGMS, measurement procedures for user performance evaluation will be performed with~     1 test meter and 1 reagent system lot by the study subjects.~      The same meter and an additional test meter will be used for double measurements performed by~     study personnel (with the same reagent system lot used by subjects).~   "
40710|NCT03033836|"~     Prospective, open, single-arm trial of dolutegravir-tenofovir and emtricitabine or lamivudine~     (DTG-TDF-FTC or 3TC) in antiretroviral (ART) naïve HIV transgender women (TGW).~      The primary objective of this pilot study is to determine the retention in care of TGW~     treated with DTG-TDF-FTC or 3TC~      Secondary objectives:~        -  To evaluate the efficacy of the antiretroviral regimen at week 48 ;~        -  To describe the safety and tolerability of this regimen;~        -  To evaluate adherence across 48 weeks;~        -  To determine the patient satisfaction with this regimen;~        -  To identify individual, social and contextual factors associated with adherence and~          retention.~   "
40711|NCT03033823|"~     This study examine the efficacy of oral magnesium supplementation as an adjuvant therapy for~     decreasing intensity of alcohol withdrawal symptoms among inpatients requiring~     pharmacological treatment of their AWS. This double blind randomized multicenter clinical~     trial planned to treat half of participants as usal plus placebo and the other half as usual~     plus magnesium.~   "
40712|NCT03033810|"~     The study will compare two invasive methods (FFR -fractional flow reserve and~     iFR—instantaneous wave free ratio) for assessment of hemodynamic impact of coronary stenosis~     on myocardial perfusion. There is a very good correlation between these methods for the~     assessment of hemodynamic significance in a broad spectrum of lesions. However, this~     correlation decreases significantly near the cut off points for each method. The~     investigators will try to find possible explanations for these differences by detailed~     morphology assessment of coronary stenosis using optical coherence tomography (OCT), analysis~     of gene polymorphisms that play a role in vasodilatation, and by shear stress analysis. The~     head-to-head comparison between FFR and iFR is not simple, because there is no gold~     standard for assessment of hemodynamic significance. Studies comparing these methods have~     used hyperemic stenosis resistance (HSR). For this kind of measurement it is necessary to~     measure the speed of blood flow. This is usually done by a Doppler analysis of flow.~     Unfortunately, the Doppler signal can yield many artificial or erroneous indicators, and~     obtaining a good quality signal is frequently time-consuming. These are the reasons that HSR~     has not been used in routine practice. The investigators have developed a new console and~     software that can provide real time analysis of the Doppler signal. It allows us to easily~     measure HSR, and to differentiate between the FFR and iFR measures through intrabeat analysis~     of microvascular resistance (lowest microvascular resistance is an essential condition for~     proper pressure measurement). Using this tool, it is possible to automatically identify the~     point of lowest microvascular resistance during each cardiac beat. The pressure gradient can~     then be measured at that point. This approach can eliminate almost all uncertainties in~     assessment of the pressure gradient produced by coronary stenosis. This tool can potentially~     improve the existing methods used to precisely reveal a significant stenosis. This should~     increase the number of hemodynamic guided procedures.~   "
40713|NCT03033797|"~     Background: Games using motion capture from webcam have become increasingly popular. A~     population that lacks much stimulus in the teaching-learning process has under-explored the~     benefits of this kind of games: The Intellectually Disabled. The aim of this study is to~     analyse the effectiveness of games with virtual reality in the total reaction time. Method: A~     convenience sample of 165 Intellectually Disabled participants will have their performance~     measured using a virtual reality game. The intervention is to play two different games twice,~     in two sessions with an interval of, at least, seven days between the sessions. Participants~     will be randomized between two raters, both master students.~   "
40714|NCT03033784|"~     The main goal of the study is to look at the effects of intranasal oxytocin on the brain in~     Autism Spectrum Disorder (ASD). Oxytocin is a hormone that exists naturally in the body and~     the brain. It affects a wide range of social behaviors and emotions. Investigators also seek~     to study how the effects of oxytocin treatment can be affected by genetic, immune and~     environmental factors.~   "
40909|NCT03031249|"~     In this open-label, randomized, prospective clinical trial, nucleophosmin-1(NPM1) mutated~     acute myeloid leukemia (AML) patients who have reached CR are randomized into two groups.The~     control group receive high-dose cytarabine(HDAC) regimen while the experimental group receive~     high dose of cytarabine plus tretinoin(ATRA) and arsenic trioxide(ATO) treatment.The safety~     and efficacy of ATRA and ATO is evaluated.~   "
40715|NCT03033771|"~     Dragon Study Europe is an international, multicenter, prospective, non-randomized study. It~     is designed to evaluate safety and performance of the MFM for the treatment of chronic type B~     aortic dissection. About 35 patients in up to 11 countries will be enrolled and screened per~     the protocol-required inclusion, exclusion criteria, in order to obtain 30 completed~     patients. For early demonstration of safety and performance, an interim analysis report will~     be performed after all patients included will complete their 6-month follow-up.~      The study purpose is to determine the safety and performance of the MFM for the endovascular~     treatment of chronic type B aortic dissection. It should be noted that the MFM has CE mark~     approval for aortic and peripheral artery aneurysms treatment.~   "
40716|NCT03033758|"~     This study will be conducted in Greek population. The patients who will be selected for study~     enrollment will receive inhaled combination of budesonide and formoterol fumarate dihydrate~     at doses 100 / 6mcg, 200 / 6mcg, 400/12 mcg through Elpenhlaler® device. The study end points~     will be efficacy and safety in patients with asthma.Additional study objectives will be~     quality of life, patient satisfaction, severe exacerbation and comorbidities.~   "
40717|NCT03033745|"~     This multicenter, open-label, parallel-arm, non-randomized study is designed to evaluate~     safety and tolerability of higher infusion parameters of IgPro20 in subjects with primary~     immunodeficiency (PID). A total of 45 subjects (including at least 14 [30%] pediatric~     subjects ≤ 17 years of age and at least 9 [20%] obese subjects with body mass index [BMI] of~     ≥30 kg/m2) with confirmed PID will be evaluated in the study. The study will include three~     cohorts of 15 subjects each as follows: i) Pump-Assisted Volume Cohort (weekly infusions),~     volume per injection site of 25 mL up to 50 mL, ii) Pump Assisted Flow Rate Cohort (weekly~     infusions), flow rate per injection site of 25 mL/hour up to 100 mL/hour, iii) Manual Push~     Flow Rate Cohort (2 to 7 infusions per week), flow rate per injection site of 25 to 30~     mL/hour up to 120 mL/hour (equivalent of approximately 0.5 mL/minute up to 2 mL/minute). Each~     cohort will test 3 infusion parameter levels (4 for the pump-assisted flow rate cohort),~     repeated at least 4 times over a duration of 12 weeks (16 weeks for the flow rate cohort).~     After 4 infusion weeks at each level, qualifying subjects (responders) will switch to the~     next infusion parameter level (eg, from 25 to 50 mL/h). During the study, the weekly dose~     will remain unchanged (as prescribed by treating physician, usually within 100-200 mg/kg per~     week range); only the respective infusion parameter under evaluation will change.~   "
40718|NCT03033732|"~     This trial evaluates two standard of care treatments for opioid addiction: methadone and~     buprenorphine/naloxone. In order to improve patient care, the study will address real-world~     treatment conditions, including strict regulations for methadone dosing (i.e. initially~     dispensed daily at the pharmacy until stabilisation) vs. flexible take-home dosing for~     buprenorphine/naloxone. The OPTIMA study is designed with the intention to support~     patient-provider decision-making and evaluate health related outcomes with the overall aim of~     improving treatment outcomes through enhancing patient-centered approaches in clinical care.~   "
40719|NCT03033719|"~     The purpose of this study is to compare the postoperative global morbidity between patients~     who have been operated on for a colon cancer by laparotomy and those operated on by~     laparoscopy~   "
40720|NCT03033706|"~     Pulse pressure variation (PPV) to standard fluid management (4ml/Kg/hr) in patients~     undergoing supratentorial mass excision. The investigators hypothesize that in these~     procedures, goal-directed fluid therapy (GDT) might improve brain relaxation, and patient~     hemodynamics intra and postoperatively.~   "
40721|NCT03033693|"~     Recent studies have shown that deep anesthesia is associated with poor outcome. There is~     still lack of randomized controlled trials with large sample size on the effect of depth of~     anesthesia on the postoperative outcomes in patients undergoing brain tumor resection. The~     investigators are performing a randomized and parallel group trial. The aim of the study is~     to determine whether there is a causal relationship between the depth of anesthesia and~     postoperative clinical outcome in patients undergoing supratentorial tumor surgery.~   "
40722|NCT03033680|"~     The specific aims of the study are:~      Primary: To determine the presence and regional distribution of microglial activation, as~     assessed by [F-18]PBR06 PET, in subjects with MSA as compared to healthy controls, at~     baseline and at 9 months follow-up.~      Secondary:~      To assess the relationship between microglial activation and clinical progression at baseline~     and follow-up.~      Hypothesis: Our working hypothesis is that there is microglial activation in Multiple System~     Atrophy and that the presence and regional distribution of microglial activation is different~     in MSA versus healthy controls and correlates with disease severity and comorbidities.~   "
40723|NCT03033667|"~     Comparative study between conventional fasting versus overnight infusion of lipid or~     carbohydrate on free fatty acids and insulin in obese patients undergoing elective first time~     on-pump coronary artery bypass grafting.~   "
40724|NCT03033654|"~     The investigators aim to investigate how much two consecutive applications of sunscreen~     before sun exposure can increase the quantities of sunscreen applied and decrease the skin~     area left without sunscreen compared to a single application. Volunteers wearing swimwear~     applied sunscreen in a laboratory environment twice and had pictures taken in black light~     before and after. As sunscreens absorb black light the darkness of the skin increased with~     increasing amounts of sunscreen applied. The investigators conducted a standard curve~     establishing a link between picture darkness and applied sunscreen quantity. Participants~     were asked to apply sunscreen the way they would normally do but two consecutive times. No~     other advice was given. The level of protection was determined by picture analysis as~     measurements of darkness of selected skin sites as well as the percentages of skin area left~     without sunscreen in different body regions and in total.~   "
40725|NCT03033641|"~     The purpose of this feasibility study is to further explore characteristics of ablation~     targets identified by CARTOFINDER 4D LAT Algorithm in subjects with persistent atrial~     fibrillation and to assess the acute outcome of CARTOFINDER Guided Ablation in terms of the~     termination of atrial fibrillation to either Normal Sinus Rhythm or Atrial Tachycardia.~   "
40726|NCT03033628|"~     The aim of this study is to compare pain during maxillary infiltration local anesthesia~     injection with the aid of DentalVibe comfort system in comparison to maxillary infiltration~     injection alone in pediatric dental patients.~   "
40727|NCT03033615|"~     This study will compare the quality of CT images acquired with very low-dose radiation and~     processed with commercially available software vs. PixelShine processed images. It would~     potentially allow imaging facilities to acquire CT scans using lower doses of radiation~     without sacrificing clarity of CT images. Acquiring high quality CT images with low-dose~     radiation has the potential to enhance patient safety and has significant implications in~     imaging practices.~   "
40728|NCT03033602|"~     The primary goal of this study is to examine whether a brief treatment approach for PTSD is~     equally efficacious in the treatment of active duty service members relative to a first line~     treatment approach that requires much greater treatment dose.~   "
40729|NCT03033589|"~     All patients over the age of 16 undergoing primary or revision anterior cruciate ligament~     reconstruction with the use of bone-patellar-bone autograft are eligible for the study.~     Patients will be randomized pre-operatively to receive either an adductor canal nerve block~     (single injection) or a femoral nerve block (single injection). Post-operatively, the primary~     outcome measures of pain level using visual analog scale as well as narcotic and non-narcotic~     analgesic requirements will be measured.~   "
40730|NCT03033576|"~     This randomized phase II trial studies how well ipilimumab with or without nivolumab work in~     treating patients with melanoma that is stage IV or stage III and cannot be removed by~     surgery. Monoclonal antibodies, such as ipilimumab and nivolumab, may interfere with the~     ability of tumor cells to grow and spread.~   "
40731|NCT03033563|"~     The study is retrospective to compare ICSI outcome of patients with cryptozoospermia or~     severe oligozoospermia after use of ejaculated versus extracted testicular sperms in~     different cycles for the same patient.~   "
40732|NCT03033550|"~     The purpose of this study is to determine whether a mobile health educational intervention~     for Human PapillomaVirus (HPV) Vaccination promotion and cervical cancer screening in Primary~     Care settings is a feasible behavioral intervention to integrate as a primary and secondary~     cervical cancer prevention approach.Study Design: The investigators will conduct an open~     feasibility proof-of-concept trial using a single experimental group with all subjects~     receiving the behavioral intervention being studied.~      Outcome measures. The primary outcome of interest is receipt of the first dose and completion~     of the three-dose series of HPV vaccine within 6 month of intervention, this will be~     evaluated by Electronic medical review review.~   "
40733|NCT03033537|"~     Introduction: Erectile dysfunction is a common condition with a significant effect on quality~     of life. Verapamil is calcium channel blocker of the phenyl alkylamine class which relaxes~     the tone of the smooth muscles lining blood vessels, leading to their dilatation.~   "
40734|NCT03033524|"~     Study Design - Multicenter, open-label, 3 arms, stepwise, phase Ⅱa clinical trial~      Study objective:~        1. Primary - To evaluate the safety of TTAC-0001 in patients with recurrent glioblastoma.~        2. Secondary - To determine the efficacy of TTAC-0001 in patients with recurrent~          glioblastoma.~        3. Exploratory~             -  To evaluate pharmacokinetic (PK) parameters of TTAC-0001 in patients with recurrent~               glioblastoma~             -  To evaluate pharmacodynamic (PD) parameters by clinical biomarker test~      Study Methodology~      Patients will be sequentially enrolled from the 1st arm. An enrollment criterion to the next~     arm is defined as no patients in the previous treatment arm showing grade ≥3 of hemangioma or~     other Dose Limiting Toxicities (DLT). A safety review committee (SRC) will convene to~     determine the patient's safety with a decision on enrollment into the next arm or change in~     dosing frequency of study drug in the above case.~      A patient who is withdrawn from the study before the completion of the 1st cycle can be~     replaced with another patient. Patients will be treated for up to 1 year, unless a cause for~     termination occurs, such as progression of disease (PD) or the withdrawal of consent.~   "
40735|NCT03033511|"~     This is a Phase 3, randomized, double-blind, placebo-controlled, multinational, and~     multicenter study to evaluate the efficacy of rovalpituzumab tesirine as maintenance therapy~     following first-line platinum-based chemotherapy.~   "
40736|NCT03033498|"~     The purpose of the study is to assess the safety, tolerability, and pharmacokinetics of~     single, ascending doses of ABBV-951 administered as a subcutaneous bolus infusion followed by~     a continuous subcutaneous infusion in subjects with Parkinson's disease.~   "
40737|NCT03033485|"~     The purpose of this study is to assess the dosimetric properties of the positron emission~     tomography (PET) imaging probe 18F labeled Picolinamide (18F-P3BZA) and preliminarily~     evaluate its diagnosis value in melanoma patients.~   "
40738|NCT03033472|"~     The aim of this prospective, randomized, placebo controlled study is to evaluate the effect~     of clindamycin on post-operative pain and swelling in adult patient with symptomatic apical~     periodontitis.~   "
40739|NCT03033459|"~     Breastfeeding is good for the health of both mother and baby, but many women do not~     breastfeed, or do not breastfeed for as long as they would like. The purpose of this study is~     to compare two types of interventions on how they impact breastfeeding. The interventions~     will be given during the third trimester of pregnancy, and the intervention is individual~     (i.e., one therapist and one participant). The first intervention is Motivational~     Interviewing, a type of counseling. The second intervention, or control group, is education~     on how babies grow and develop. There general aims of this study are to compare women in the~     Motivational Interviewing group and control group on how they plan to feed their babies, how~     much they learn about and their opinions about breastfeeding, and how much they learn about~     how babies grow and develop. In addition, the groups will be compared as to whether they~     start breastfeeding, and how they are feeding their baby when the baby is one month old.~   "
40740|NCT03033446|"~     The purpose of this study is to evaluate the effect of liver-localised radioembolization and~     nivolumab on liver cancer.~   "
40741|NCT03033433|"~     An Open-Label Phase I Study to Assess the Safety and Tolerability Profile of Three Escalating~     Doses of DCB-DM101 in Healthy Volunteers and Optimum Dose of DCB-DM101 as Add-on Treatment in~     Type 2 Diabetes Mellitus (T2DM) Patients~   "
40765|NCT03033121|"~     Growth hormone (GH) treatment in patients with GH deficiency (GHD) is commonly administered~     daily, although the pulsatile GH secretion is unlikely to be achieved and this regimen is~     often not complied. The auxological effect of three injections per week (TIW) regimen is~     controversial, while the metabolic effects were never evaluated in children. The objective of~     this study was to evaluate whether two different regimens of weekly injections could lead to~     similar auxological and metabolic effects in children with GHD.~   "
40742|NCT03033420|"~     Unipolar and bipolar disorder combined account for nearly half of all morbidity and mortality~     due to mental and substance use disorders, and burden society with the highest health care~     costs of all psychiatric and neurological disorders. Among these, costs due to psychiatric~     hospitalization is a major burden. Smartphones comprise an innovative and unique platform for~     monitoring and treatment of depression and mania.~      The RADMIS trials use a randomized controlled single-blind parallel-group design. Patients~     with unipolar or bipolar disorder discharged from psychiatric hospitals in The Capital Region~     of Denmark are invited to participate. Patients are at discharge from the psychiatric~     hospitals randomized, separately according to psychiatric diagnosis (thus, the RADMIS trial~     consists of two separate trials according to diagnosis, bipolar disorder or unipolar~     disorder), to: 1) a smartphone-based monitoring system including a) an integrated feedback~     loop between patients and clinicians and b) context-aware CBT modules (intervention group) or~     2) treatment-as-usual (control group) for a 6-months trial period. The trial is started in~     March 2017. The outcomes are 1) differences in the number and duration of re-admissions~     between the intervention group and the control group (primary), 2) differences in severity of~     depressive and manic symptoms (manic symptoms only for patients with bipolar disorder);~     differences in psychosocial functioning; and differences in number of affective episodes~     between the intervention group and the control group (secondary), and 3) differences in~     perceived stress, quality of life, self-rated depressive symptoms, self-rated manic symptoms~     (only for patients with bipolar disorder), recovery, empowerment, adherence to medication,~     well-being, ruminations, worrying, and satisfaction between the intervention group and the~     control group (tertiary).~   "
40743|NCT03033407|"~     The aim of this study is to investigate whether adding tailored mobile coaching system to~     present community primary care for diabetes management would result in better glycemic~     control and other diabetes-related outcomes in adult patients with type 2 diabetes, compared~     with maintaining usual diabetes management only.~   "
40744|NCT03033394|"~     Currently in the UK, TDM is routinely performed for aminoglycosides and glycopeptide~     antimicrobial agents, given fears over the narrow therapeutic window of these agents and the~     serious adverse events associated with toxicity. However, in critical care the role of TDM~     for optimisation of therapy has been demonstrated to help optimise dosing of patients who~     tend to have variable pharmacokinetic parameters (J. A. Roberts et al,). This is of growing~     importance given that low concentrations of antimicrobial agents, below a micro-organisms~     minimum inhibitory concentration (MIC) is believed to be a major driver of AMR. The~     investigators set out to explore whether similar observations in PK-PD target variability are~     currently being observed across the secondary care setting (outside of critical care) and~     whether these appear to be impacting on clinical outcomes.~   "
40745|NCT03033381|"~     Here, investigators aimed to evaluate the effect of inguinal operations performed with a~     modified Ferguson technique upon testicular volume and blood flow. This study involved 23~     patients receiving surgery for inguinal hernia, hydrocele, and cord cyst. The color Doppler~     ultrasound (CDUS) was used to assess testicular volume and blood flow before and after a~     modified Ferguson technique surgery. The pre- and postoperative testicular volume and blood~     flow were compared with the contralateral testes. Statistical Package for the Social Sciences~     (SPSS) software was used to statistically analyze the data arising; the Mann-Whitney U test~     and Friedman test were used to compare samples, and P < 0.05 was accepted as statistically~     significant.~   "
40746|NCT03033368|"~     To describe the immunologic and virologic outcomes (HIV RNA, CD4) following switching from~     EFV to RPV in virologically suppressed adolescents~   "
40747|NCT03033355|"~     The purpose of this prospective research study is to evaluate higher neural changes following~     intradetrusor injection of Botulinum toxin-A (BTX-A) in patients with Multiple Sclerosis~     (MS). Concurrent Urodynamic and Functional Magnetic Resonance (fMRI) data will be recorded~     pre- and post- intravesical injection of BTX-A in patients with Multiple Sclerosis (MS) and~     neurogenic detrusor activity (NDO).~      Other objectives are to evaluate the role of urinary biomarkers such as brain-derived~     neurotropic factor (BDNF) and nerve growth factor (NGF) associated with bladder overactivity~     and, to determine whether the common validated urgency questionnaires correlate with fMRI~     findings and urinary biomarker concentration pre- and post- BTX-A injection in patients with~     MS and NDO.~   "
40748|NCT03033342|"~     A phase one study of the safety, tolerability, and pharmacokinetics of a new oxazolidinone~     antibiotic. Cohorts of healthy adults (female and male) will participate in:~      single dose escalation study of increasing doses of MRX-4 given by mouth others will~     participate in multiple dose escalation cohorts of MRX-4 given twice daily by mouth.~      other cohorts of subjects will participate in the study to evaluate the impact of concomitant~     food or Omeprazole on safety, tolerability and pharmacokinetics of MRX-4~   "
40749|NCT03033329|"~     A Phase 1 study of the safety, tolerability, and pharmacokinetics of a new oxazolidinone~     antibiotic. In Part 1 cohorts of healthy adults will participate in a single dose escalation~     study of increasing intravenous doses of MRX-4. In Part 2 cohorts of healthy adults will~     participate in a multiple dose escalation study of increasing intravenous doses of MRX-4~     given twice daily for ten days. Part 3 is a crossover study of oral MRX-4 versus a comparable~     intravenous dose of MRX-4 to determine bioavailability.~   "
40750|NCT03033316|"~     Oncocort Dexamethasone sodium phosphate encapsulated in so-called 'long-circulating'~     PEGylated liposomes is in development with the prospect of providing enhanced and prolonged~     lesion uptake of dexamethasone and therefore increased therapeutic benefit over existing~     formulations of dexamethasone in Multiple Myeloma. The current trial is a first-in-man study~     with Oncocort monotherapy with the objective to assess safety, tolerability, efficacy and~     dose response after short-term treatment with repeated infusions.~   "
40751|NCT03033303|"~     The purpose of this study is to test see the combined effects of the study drug called~     Humanized 3F8 (Hu3F8) when used with granulocyte-macrophage colony stimulating factor~     (GM-CSF). Hu3F8 plus GM-CSF could prevent your neuroblastoma from growing, but it could also~     cause side effects.~   "
40752|NCT03033290|"~     Allergic rhinitis is an importance disease in Taiwan with its high incidence about 20-30% and~     gradually increased annually. However, symptom relapse still bothered the majority of~     patients though there were certain advances in western medicine. In addition, side effects of~     western medicine, such as lethargy, mouth dryness were noted. Traditional Chinese medicine,~     especially qi-tonifying regimen has been used and proved benefit to the allergic diseases by~     many researchers.This study will provide the evidences of gut microbiota changes and~     immune-modulatory effects of BZYQT for the treatment of allergic rhinitis.~   "
40753|NCT03033277|"~     There is a high incidence of women suffering from Primary Ovarian Insufficiency (POI). One of~     the most common treatments for POI is hormone replacement therapy (HRT), but HRT doesn't work~     well, and it has been shown to increase the risk of blood clots in the veins, ovarian cancer,~     and breast cancer. The ability of MSCs to differentiate into oocyte-like cells has been~     previously documented. Herein the purpose of this work is to evaluate the therapeutic~     potential of cell therapy in women suffering from POI.~   "
40754|NCT03033264|"~     Women with a BMI>30 and women with a BMI<30 will be divided in a randomized controlled manor~     to 4 groups depending on the mode of labor induction and BMI value:~        1. Dinoprostone in women with a BMI>30.~        2. Dinoprostone in women with a BMI<30.~        3. Cervical ripening balloon in women with a BMI>30.~        4. Cervical ripening balloon in women with a BMI<30. The subjects will be followed until~          labor, and information regarding the success of induction, mode of delivery and time of~          delivery will be collected from patients` electronic files.~   "
40755|NCT03033251|"~     Chronic obstructive lung disease is a disabling disease that affects people usually after~     several years of smoke tobacco exposure and affects millions of patients worldwide. The~     disease is marked by multiples episode of worsening, termed exacerbations necessitating~     frequent hospitalizations. During these exacerbations, patients present breathless, and in~     the most severe cases, are admitted to an Intensive Care Unit (ICU) for respiratory~     assistance. Currently, respiratory assistance is provided by a ventilator via a oronasal mask~     (referred to non-invasive ventilation, NIV), that helps patients to cope with their~     breathless. The mask is not always well tolerated and the ventilator sessions are delivered~     intermittently. In the past decade, a new technique that provides air-oxygen with high flow~     has been developed. This technique, called High Flow via Nasal Cannula (HFNC) can deliver~     from 21 to 100% heated and humidified air-oxygen at a high flow of gas via simple nasal~     cannula. Recent studies have shown that the technique is very efficient to treat patients~     presenting with acute respiratory failure who don't have any underlying chronic pulmonary~     disease. Whether the technique would be also efficient in patients with COLD presenting with~     severe exacerbations has not yet been demonstrated. Since HFNC does not require any mask, it~     is thought that the comfort of the patient would be much better in comparison to NIV and~     could potentially help to treat many patients with the disease. The objective of the present~     study is to study the physiological effect of HFNC as compared to NIV in patients with severe~     exacerbations of COPD and to show that it is non-inferior to NIV.~   "
40756|NCT03033238|"~     The purpose of this study is to investigate opportunities for prevention and treatment of~     knee osteoarthritis (OA) by evaluating potentially modifiable risk factors for disease and~     poor pain and physical function outcomes especially among those with early or mild knee~     symptoms. The goal of the study is to find novel strategies to prevent disease at an early~     stage and to limit the impact of disease once it has occurred.~   "
40757|NCT03033225|"~     The goal of project is to target of locally advanced pancreatic cancer (LAPC) with a~     photodynamic therapy (PDT) to evaluate response of tumor.~   "
40758|NCT03033212|"~     This investigation will assess how the timing and type of rehabilitation after a~     transforaminal lumbar interbody fusion will affect the efficacy of the surgical procedure.~     The efficacy of the procedure will be evaluated through patients' quality of life, measured~     by health-related quality of life questionnaires up to 24 months following the procedure.~     These measures will be compared to the patients' baseline value.~   "
40759|NCT03033199|"~     Primary immune thrombocytopenia (ITP) is an acquired autoimmune bleeding disorder, accounting~     for about 1/3 of clinical hemorrhagic diseases. Loss of immune tolerance leading to increased~     platelet destruction and decreased platelet production is the main pathogenesis of ITP.~     Dysbiosis of the gut microbiota was found in many autoimmune diseases like rheumatic~     arthritis(RA),inflammatory bowel disease(IBD),multiple sclerosis and probiotic treatment or~     fecal microbiota transplantation(FMT) which can regulate the gut microbiota has good clinical~     efficacy in those disorders. One ITP patient with ulcerative colitis(UC) was treated with FMT~     and got progressive but significant increase in platelet level and lasted for several years.~   "
40760|NCT03033186|"~     Metastatic (HR-positive, HER2-negative) breast cancer (BC), advanced or unresectable~     neuroendocrine tumours of pancreatic (pNET), gastrointestinal or lung origin and metastatic~     renal cell carcinoma (mRCC) are diseases with poor outcome. Everolimus increases patients'~     median progression-free survival (PFS) with 4.6 months in metastatic BC (mBC), 7 months in~     (p)NET and 3 months in mRCC. However, serious adverse events (AEs) occur frequently. This~     reduces effectiveness of everolimus, because AEs are managed with dose reductions, treatment~     interruptions or even complete discontinuation of everolimus.~      Therapeutic-drug-monitoring (TDM) is used to adjust the prescribed daily dose, to maintain~     effective everolimus whole blood concentrations, with the lowest possible risk of AEs. While~     everolimus TDM has been common in transplantation medicine, it has not been implemented in~     oncology.~      The importance of TDM in oncology is supported by previous research which showed that a~     2-fold increased everolimus whole blood trough concentration was associated with a short-term~     risk of grade ≥ 3 pneumonitis, stomatitis and metabolic events. Moreover, an~     exposure-toxicity relationship of everolimus in patients with thyroid cancer was observed,~     since initial everolimus concentrations could be associated with early toxicity (< 12 weeks,~     e.g. stomatitis). However, the association between initial everolimus measurements and~     long-term AEs (≥12 weeks, e.g. pneumonitis, anorexia and anemia) of any grade and the need~     for everolimus dose reductions could not be made. Since levels ±>18 µg/L were associated with~     toxicity, the investigators assume that the upper therapeutic window of everolimus in the~     oncologic setting will be ±18 µg/L. Similarly, a tendency to improved PFS and overall~     survival was observed when Cmin in steady state was above 14.1 μg/L. This seems to be the~     lower limit of the therapeutic window.~      Before consensus about the feasibility of everolimus TDM in the oncologic setting can be~     achieved, a number of questions (the knowledge gaps) need to be answered: 1. It is unknown~     whether everolimus whole blood trough levels (over time) predict long-term AEs. 2. The~     optimal concentration range for everolimus, with the treatment of mBC, mRCC, or (p)NET is~     unknown, especially the upper limit associated with toxicity. 3. It is unknown what~     everolimus concentration level is associated with the need for everolimus dose reductions.~   "
40761|NCT03033173|"~     An innovative diagnostic ultrasound method for carpal tunnel syndrome was proposed and~     compared between carpal tunnel syndrome patients and healthy volunteers.~   "
40762|NCT03033160|"~     The specific aim of this protocol is to determine whether vaginal estrogen is an effective~     treatment for asymptomatic microscopic hematuria in postmenopausal women. The investigators~     hypothesize that women who use vaginal estrogen for three months will be more likely to have~     resolution of their asymptomatic microscopic hematuria compared with women who do not use~     vaginal estrogen.~   "
40763|NCT03033147|"~     The aim of this prospective, randomized, placebo controlled study is to evaluate the effect~     of a single preoperative dose of amoxicillin/clavulanic acid combination on post-operative~     pain and swelling in adult patient with symptomatic apical periodontitis.~   "
40764|NCT03033134|"~     The purpose of this study is to confirm the safety and effectiveness of the BSJ003W in~     Japanese patients with non-valvular atrial fibrillation at increased risk of thromboembolism~     in Japanese Clinical environment~   "
40766|NCT03033108|"~     This is a pharmacodynamics study of emixustat hydrochloride in subjects with macular atrophy~     secondary to Stargardt disease.~   "
40922|NCT03031080|"~     The BOND study is a prospective, randomised single blinded controlled trial to assess the~     effect of night splinting in patients who have had collagenase injection and manipulation~     therapy for Dupuytren's Contracture.~   "
40770|NCT03033056|"~     Anxiety disorders are among the most prevalent, costly, and disabling mental illnesses. One~     central, yet largely understudied, abnormality in anxiety disorders is the heightened~     tendency to display fear and avoidance in reaction to benign or safe events that resemble~     feared situations. The current project maps brain circuits associated with this abnormality~     in order to contribute to future brain-based diagnosis and treatments for clinical anxiety.~   "
40771|NCT03033043|"~     This clinical trial is a prospective, multicenter, non-blinded, non-randomized study designed~     to assess the RelayPro thoracic endografts in the treatment of acute, complicated type B~     aortic dissection. The primary endpoint will measure all-cause mortality at 30 days~     post-procedure.~   "
40772|NCT03033030|"~     Breast cancer remains a worldwide big killer with a rate of deaths compared with newly~     diagnosed cases not lower than 20%. Mammography is the primary imaging modality for the early~     detection of clinically occult breast cancer. Mammography is established as the primary~     investigation for population-based breast cancer screening. Advances in mammographic~     technique regarding both hardware and software applications are still not sufficient to~     overcome mammography's limitation with regard to both sensitivity and specificity. Depending~     on several factors, such as age and breast density, mammography screening is associated with~     a false-negative rate of 10-20 %.~      Digital Breast Tomosynthesis (TS) is a novel technique that is able to study the breast using~     3D reconstructions of the tissue from multiple low-dose digital mammographic images acquired~     in several planes in a 15 to 50 degree angle. This process aims at a increasing the number of~     lesion visible due to the reduction of overlapping breast tissue.~      In TS, to overcome these limitations, a digital mammography (DM) unit is modified to allow~     the X-ray tube to move through a proscribed arc of excursion acquiring a fixed number of~     discrete projection images while the breast remains in compression. The individual projection~     images are extremely low in dose, so the composite dose incurred during a TS acquisition may~     be similar to that of a standard 2D mammography. The radiologically dense breasts are~     associated with decreased sensitivity of mammography, both in the clinical and screening~     setting as well as its established association with breast cancer risk. The systematic~     application of ultrasound (US) in women with radiologically dense breasts and negative~     mammogram has been shown to be associated with an additional cancer detection rate [7,8,9].~     Incremental ultrasound detection of cancer may be considered in the range of 0.27% to 0.52%~     of ultrasound-screened women in different density categories [10]. In addition, the main~     limitation of US in breast screening is represented by false- positive findings. These~     findings result in additional investigation or unnecessary surgical biopsy [10].~   "
40773|NCT03033017|"~     This is a two-center study of 30 HIV-infected participants who have been on antiretroviral~     therapy (ART) for at least two years.~      Participants will be asked to undergo LN and GALT biopsies both before and after a closely~     monitored analytic treatment interruption (ATI).~   "
40774|NCT03033004|"~     Sixty healthy subjects aged between 18 and 50 will be randomly allocated into three treatment~     groups: Conventional Cryolipolysis, Contrast Cryolipolysis or Recovery Reperfusion~     Cryolipolysis. The region will be treated according to the individual need, in the region of~     abdomen and flanks. Assessments of body composition will be performed at baseline and 30, 60~     and 90 days after randomization. Blood collections will also be performed at baseline and~     between 14 and 21 days after randomization for evaluation of lipid profile and liver~     function.~   "
40775|NCT03032991|"~     The prospective multicenter study GD-Brain provides a better knowledge on the basis of~     neurological impairment in children born to mothers with gestational diabetes (GDM). GDM~     modifies placental structure and affect materno-fetal nutrient transfer. Docosahexaenoic acid~     (DHA) play an important role on neurodevelopment, and it is reduced in venous cord blood of~     newborns born to GDM. In previous studies, we have already demonstrated impaired DHA fetal~     levels not only using label fatty acids with stable isotopes administrated to pregnant women,~     but also in observational studies in GDM as the prevention of obesity study (PREOBE study) in~     Granada and other similar study in Murcia. The impaired cord DHA levels were associated to~     disturbed neurodevelopment in these children during the first year of life. However, it is~     uncertain the mechanisms underlying this impaired materno-fetal DHA transfer and implications~     for later life.~      The recent publication in Nature Journal of a selective transmembrane carrier for DHA in~     brain named major facilitator superfamily domain 2a (MFSD2a) open new expectations. We~     detected disturbed MFSD2a levels in placentas from GDM which could be due to structural~     problems in this organ; inflammation, oxidation and metabolic changes related to diabetes~     might affect MFSD2a activity. Moreover, it is difficult to know whether disturbed MFSD2a~     levels in placenta may also indicate altered levels of this carrier in the brain from~     children born to GDM mothers, which could contribute to neurodevelopment impairment in these~     subjects. Recent studies also indicate that obesity alters the biosynthesis of eicosanoids~     derived from DHA, with a decrease of protectins and resolvin of D-series, which have powerful~     anti-inflammatory properties.~      The main aim of this study is to analyse potential differences on neurodevelopment, and brain~     structure and functioning, in children 8 years old born to GDM respect to those born to~     healthy normoweight mothers, as well as to identify early biomarkers consistently related to~     neurodevelopment from early stages of life.~   "
40776|NCT03032978|"~     Clinical and microbiological evaluation of Calcium silicate versus Calcium hydroxide in~     two-step indirect pulp treatment: Randomized clinical trial~   "
40777|NCT03032965|"~     The purpose of this study is to determine if additional ablation during the first procedure~     as the result of the ability to medically induce quiet atrial arrhythmias will improve~     clinical outcome in patients with atrial fibrillation thus decreasing the need for additional~     ablation procedures.~   "
40778|NCT03032952|"~     This was a 12-week, parallel randomised controlled trial, including a 6-week follow-up. The~     trial compared a group of university students (N = 84) receiving a mobile CBT application~     intervention (Feel Stress Free) to a wait-list control group (N = 84) receiving no~     intervention. Participants were asked to complete the Hospital Anxiety and Depression Scale~     (HADS) and the Patient Health Questionnaire (PHQ-9) at baseline (as part of the screening~     questionnaire) and then fortnightly for the 12 weeks. Although blinding was not possible~     owing to the nature of a wait list control group, researchers did not have any face-to-face~     contact with the participants, as recruitment and participation in the study was entirely~     completed online.~   "
40779|NCT03032939|"~     Intraoperative stress responses (vasoconstriction and changes in heart rate) and~     postoperative pain can be monitored using photoplethysmography (PPG). PPG measures changes in~     tissue volume noninvasively. Therefore it can measure acute changes in arterial diameter~     (vasoconstriction). PPG signal has two components, AC and DC. Effects of noxious~     stimuli-induced stress responses (vasoconstriction) have not been studied on the DC component~     of PPG. The aim of this study was to investigate the effect of a known noxious stimulus~     (endotracheal intubation) on both the AC and DC components of PPG.~   "
40780|NCT03032926|"~     The goal of this proposed study is to identify a potential biobehavioral marker of CBT~     outcome in the most common child and adolescent anxiety disorders, including separation~     anxiety disorder (SAD), social phobia (SoP), and generalized anxiety disorder (GAD), and to~     replicate in a clinical sample the previous finding from animal and non-clinical human~     samples that a difference exists in extinction learning across development.~   "
40971|NCT03030443|"~     This study will use semi-structured interviews with participants in a prospective cohort~     study to explore women's experiences of pain and preferences in pain management during first~     trimester surgical abortion to create a more patient centered experience. We will analyze two~     study cohorts of women undergoing first trimester surgical abortion: women choosing oral~     anesthesia and women choosing nitrous oxide.~   "
40781|NCT03032913|"~     The proposal aims at determining whether liquid biopsy approaches are valid in the diagnosis~     of pancreatic cancer. Step1 will test 3 CTC isolation methods and analyse by flow cytometry~     the presence of onco-exosomes in the culture media of pancreatic cell lines. Step 2 will~     examine the diagnostic accuracy of these blood tumor elements for the diagnosis of cancer of~     patients with PDAC suspicion or recent diagnosis and their value for disease monitoring.~   "
40782|NCT03032900|"~     This study aims to describe incidence of right ventricular dysfunction after major lung~     resection with echocardiography criteria.~   "
40783|NCT03032887|"~     The rate of infectious diseases (amnioninfection syndrome (AIS), fetal inflammatory response~     syndrome (FIRS), early-onset neonatal sepsis (EONS)) in perinatal care / neonatology is~     steadily rising in Germany. The hands of the staff and visitors are the most important~     transmission vehicle of pathogens. Hence hand hygiene is one of the most important measures~     for the prevention of hospital infections. The different measures of hand hygiene serve to~     protect against the spread of contamination of the skin with obligate or potentially~     pathogenic pathogens. Since the use of antibiotics is generally only possible to a limited~     extent (especially in pregnant women and neonates in perinatal care centers) the primary~     prophylactic measures are of great importance.~      While the importance of hand disinfection in the staff has been undisputed, there is no data~     on the rate of hand disinfection for visitors of perinatal care centers. Visitor at these~     stations are common non-compliant persons (especially children!). On the other hand, pregnant~     women and young mothers and newborn babies are exposed to a large number of visitors~     compared to other stations.~      The investigators examine whether special measures (such as voice prompts) have a positive~     effect on the rate of performed hand disinfections or consecutively on the infection rate.~   "
40784|NCT03032874|"~     Patient age 45 year old and above who presented with rectal bleeding at three tertiary~     hospitals in South West Nigeria were invited for colonoscopy. The clinical information of the~     patients and the colonoscopy data were analyzed~   "
40785|NCT03032861|"~     This study aimed investigate the chronic effect of orange juice consumption on gut microbiota~     and in the bioavailability of flavanones and metabolites by feces, blood and urine analysis.~   "
40786|NCT03032848|"~     To evaluate the difference of three vaginal estrogens creams comparative with placebo on~     improvement of hormonal cytology, local and systemic climacteric complaints, as well as its~     endometrial security.~   "
40787|NCT03032835|"~     Calciphylaxis, a vascular calcification disorder, is a rare and serious disorder~     characterized by calcification of dermal arterioles.~      There are significant gaps in the understanding of the pathophysiology and risk factors for~     calciphylaxis. At present, there is no effective treatment. Uncertain pathobiology, rare~     incidence and lack of collaborative approach have been some of the major limiting factors~     towards treating calciphylaxis.~      The Partners Calciphylaxis Biorepository (PCB) aims to address these gaps within~     calciphylaxis research by utilizing existing and, when necessary, developing new~     infrastructure to support the consent of patients and the collection of dedicated samples for~     a calciphylaxis repository.~   "
40788|NCT03032822|"~     At the Ohio State University, and across the country, surgical patients admitted to the~     hospital are over-prescribed a significant amount of opioid medications upon discharge to~     home. Recent studies reveal that a large percentage of patients prescribed opioid medications~     after surgery have approximately half of the prescribed medication left over. This study aims~     to evaluate reported opioid use after surgery in patients undergoing cystectomy in order to~     better approach the issue with current opioid use and abuse trends while still providing~     adequate medical care and pain management to patients.~   "
40789|NCT03032809|"~     The aims of this study are to optimize MR imaging and MR angiography sequences and image~     reconstruction for 3T magnetic resonance imaging system scanners, which are already used in~     the clinical environment on patients with or with suspected intracranial vasculopathies.~     Improvements in these areas will have positive implications for medical diagnosis and~     treatment.~   "
40790|NCT03032796|"~     The primary goal of this project is to evidence potential synergistic benefits on cognitive~     control processes using a video game (Body-Brain Trainer, or BBT) that integrates cognitive~     and physical challenges in a complimentary fashion. Healthy adults will be recruited for a~     longitudinal experiment and randomly assigned to one of four study groups to mechanistically~     tease apart the possible presence of any synergistic effects on cognitive abilities through~     the combination of cognitive & physical challenges.~   "
40791|NCT03032783|"~     This phase II trial studies the how well donor stem cell transplant works in treating~     patients with high risk hematologic malignancies. Giving total-body irradiation and~     chemotherapy before a donor stem cell transplant helps stop the growth of cells in the bone~     marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop~     the patient's immune system from rejecting the donor's stem cells. When the healthy stem~     cells from a donor are infused into the patient they may help the patient's bone marrow make~     stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may~     also replace the patient's immune cells and help destroy any remaining cancer cells.~   "
40792|NCT03032770|"~     Placenta accreta is a substantially life threatening condition and one of the causes of~     maternal morbidity and mortality in the world. According to study done in United Kingdom, The~     estimated incidence of placenta accreta/increta/percreta was 1.7 per 10,000 maternities~     overall and 577 per 10,000 in women with both a previous cesarean delivery and placenta~     previa. in a tertiary south Italian center, The incidence increased from 0.12% during the~     1970s, to 0.31% during the 2000s.While in United States of America, the prevalence of~     placenta accreta was 3.7 per 1000 deliveries.~   "
40839|NCT03032159|"~     Text2Breathe (T2B) is a randomized controlled trial aimed at improving communication between~     parents and their children's' primary care providers about asthma. The overarching goal of~     this study is to reduce disparities among a population with high rates of pediatric asthma~     morbidity. The investigators are testing the efficacy of a short message service~     (SMS)-enhanced health communication (HC) intervention (Text2Breathe) designed to equip~     urban, low-income parents with tools for communicating effectively with their children's~     primary care provider (PCP).~   "
40972|NCT03030430|"~     The purpose of this study is to establish PK similarity in the treatment of BAT1706 and~     comparators.~   "
40793|NCT03032757|"~     Age-associated loss of muscle mass, termed sarcopenia, is strongly associated with functional~     impairment and physical disability in the elderly. Maintenance or growth of muscle mass is~     mainly driven by increased muscle protein synthesis (i.e. the generation of new muscle~     protein) in response to exercise and feeding. However, several investigations have shown that~     elderly individuals have a blunted protein synthetic response following protein intake. This~     inability of the elderly to properly respond to growth stimuli has been termed anabolic~     resistance and plays a significant role in the development of sarcopenia. However, the~     precise mechanisms underpinning anabolic resistance are unknown.~      It is well established that muscle protein synthesis at the molecular level is regulated by a~     cellular protein complex called mTORC1. When exposed to a growth stimulus, mTORC1 has been~     shown to associate with lysosomes, i.e. the intracellular organelles responsible for the~     breakdown of cellular proteins, and subsequently moving towards the cell periphery.~      This movement of lysosome-associated mTORC1 within the cell is believed to be vital for the~     activation of protein synthesis, as inhibition of lysosomal movement blunts mTORC1 activation~     in response to amino acids. Thus, dysregulation of lysosomal movement in ageing muscle may~     represent an underlying mechanism in the development of anabolic resistance. However, this~     area of research is unexplored in the context of human skeletal muscle. The investigators~     hypothesize that dysregulation of lysosomal movement plays a central role in the development~     of age-associated skeletal muscle anabolic resistance.~   "
40794|NCT03032744|"~     Project IMPACT is a school-based health center intervention program that institutes~     guideline-based chronic asthma care and provides supervised administration with daily~     preventive asthma medications to improve asthma symptoms and lung function, reduce emergency~     visits, and decrease missed days of school among children from communities with health~     disparities.~   "
40795|NCT03032731|"~     Many healthy lifestyle interventions have been developed to help people change their activity~     and diet, lose weight and thus reduce their risk of developing type 2 diabetes (T2DM) and~     cardiovascular disorders (CVD). However, these interventions often fail to engage their~     target audience, which undermines their effectiveness in changing behaviour and health~     outcomes.~      The purpose of this study is to investigate the efficacy of a self-directed, website-based~     intervention to promote physical activity and healthy dietary behaviours. The intervention~     frames health information from a novel perspective, which our previous work has indicated can~     help to promote interest in the health information and improve attitudes, self-efficacy and~     motivation towards physical activity and healthy dietary behaviours.~      The intervention comprises a website of information resources and personal recording areas to~     set goals and monitor activity and diet, weekly emails and pedometers. In this trial we aim~     to see whether the intervention has any impact on people's physical activity and diet, as~     well as their risk of developing CVD and T2DM. The intervention will be compared with a~     control condition in which participants will be shown standard resources available on NHS~     websites. Overweight/obese (BMI 25 - 39.5) males and females aged 35-74 years will be~     recruited from the community. The active intervention will last 6 weeks (during this period~     participants will receive weekly emails from the research team) and there will be a 6-week~     follow-up phase (in which participants will still have access to the website but contact from~     the research team). Activity, diet, disease risk markers and psychological antecedents of~     behaviour will be assessed at baseline, post-intervention (6-weeks) and post follow-up (12-~     weeks).~   "
40796|NCT03032718|"~     Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and clinically~     meaningful side effect of cancer treatment. It is induced by neurotoxic chemotherapeutic~     agents, causing severe sensory and/or motor deficits such as pain, altered sensation, reduced~     or absent reflexes, muscle weakness, reduced balance control, insecure gait, and higher risk~     of falling. It is associated with significant disability and poor recovery, not only reducing~     patients' autonomy and quality of life but also limiting medical cancer therapy, which~     subsequently may affect the clinical outcome and compromise survival. To date, CIPN cannot be~     prevented and approved and effective treatment options are lacking.~      Promising results regarding CIPN have recently been achieved with exercise. Own preliminary~     work revealed that patients profit from sensorimotor training (SMT), experiencing significant~     relief from CIPN induced symptoms. In a pilot study we therefore also evaluated whole body~     vibration training, a further neuromuscular stimulating exercise intervention. Results~     suggest that whole body vibration (WBV) is not only feasible and safe for neuropathic cancer~     patients but can attenuate motor and sensory deficits.~      We therefore propose a two-armed, multicenter, randomized controlled trial (RCT with a~     follow-up period), including 44 patients with neurologically confirmed CIPN, in order to~     evaluate the effects of WBV on the relevant symptoms of CIPN. Primary endpoint is the patient~     reported reduction of CIPN-related symptoms (FACT-GOG-Ntx). Secondary endpoints will include~     compound muscle action potentials, distal motor latency, conduction velocity, and F-waves~     from the tibial and peroneal nerve as well as antidromic sensory nerve conduction studies of~     the sural nerve, feasibility, non-invasive electromyographic (EMG) activity of mm. tibialis~     anterior, soleus, gastrocnemius medialis, rectus femoris, vastus medialis and biceps femoris,~     peripheral deep sensitivity, proprioception, balance control as well as pain, quality of life~     and the level of physical activity. Patients will be assessed before and after a 12 week~     intervention and again after 12 weeks of follow-up. Interim tests will be performed 6 weeks~     into the intervention as well as every 3 weeks during the follow-up.~      We hypothesize that individually tailored whole body vibration training will reduce relevant~     symptoms of CIPN. Our results could contribute to improve supportive care in oncology,~     thereby enhancing patients' quality of life and coincidentally enabling the optimal medical~     therapy.~   "
40797|NCT03032705|"~     The purpose of this study is to compare esthetic, functional and biological properties of two~     restoration materials used to fill cavities. One material is called Filtek™ Supreme which~     is a traditional tooth colored resin composite that is placed in the cavity in layers and~     hardened with UV light. The second material is called SonicFill™ 2, which is a bulk fill~     composite that uses an ultrasonic hand piece to change the material from a solid into a~     liquid in order to place it into the cavity. This material can be placed in the cavity in 1~     layer, and is hardened using UV light. Both materials have been FDA approved as~     non-significant risk devices for filling cavities.~      In each subject, one tooth with a cavity will be randomly selected to receive one filling~     material, and a second tooth with a cavity will be randomly selected to receive the second~     material. The fillings will be observed over a two year period to determine clinical~     acceptability.~   "
40858|NCT03031912|"~     This is a randomized, placebo-controlled, multi-site, double-blind trial of V920~     (rVSVΔG-ZEBOV-GP) Ebola Virus vaccine candidate in subjects with HIV infection to be~     conducted in conformance with Good Clinical Practices. The study will take place at 2~     Canadian sites (Centre Hospitalier de l'Université de Montréal and Ottawa General Hospital)~     and 2 African sites (Centre MURAZ, Burkina Faso and Centre Hospitalier National Aristide Le~     Dantec, Dakar, Senegal). The Duration of Study: 365 days for each participant not including~     screening.~   "
40798|NCT03032692|"~     The study was designed to evaluate the impact of a novel kinematic biofeedback system - SWORD~     - in the motor performance of patients after stroke. The SWORD system combines inertial~     motion trackers and a mobile app, allowing digitization of patient motion and providing~     real-time audiovisual biofeedback.~      The investigators hypothesize that the biofeedback feedback provided by the SWORD system~     improves patient performance, defined as an increase in the number of correct movements.~      The design of the study is a cross-over randomized clinical trial. Patients will be~     randomized into two groups. Both will perform two separate sessions consisting of one~     exercise - shoulder flexion with elbow flexion at 90 degrees - for 4 minutes in both~     experimental settings: with and without biofeedback. Group 1 will perform the exercise with~     biofeedback first and without biofeedback after, with an interval >24h. Group 2 will perform~     the exercise in the opposite order. The SWORD system will be used to record movement data in~     both sessions, but the feedback was only active in one of them.~   "
40799|NCT03032679|"~     After Institutional Review Board approval, adult patients scheduled for total knee~     arthroplasty (TKA) will be enrolled into the study after obtaining informed consent over a 24~     month period. Interim analyses of cases who have completed the 6 month follow up as on 31st~     October, 2017 will be analyzed as part of the co- principle investigator's thesis. All~     consenting patients will be assessed for pain preoperatively, the first 3 post-operative~     days, at 1, 4 and 6 months from the date of surgery. Pain scores will be assessed using the~     Numerical Rating Scale during the 3 postoperative days. Pain will be managed by the Acute~     Pain Service team as per standard protocols.~      The Brief pain inventory (BPI) (short form with translations, obtained with permission from~     MD Anderson), which assesses pain severity and its impact on daily functions will be~     administered to the patient in a language familiar to them, preoperatively, at 1, 4 and 6~     months postoperatively.~      The Musculoskeletal Tumour Society Score (MSTS) which evaluates the functional condition~     (impairment) after completed tumour treatment will be estimated at the end of 6 months from~     the date of surgery The painDETECT questionnaire (PD-Q) a quick, simple and reliable~     screening tool to identify the likelihood of a neuropathic pain component in patients and~     validated in various languages including Hindi and Marathi will be administered~     preoperatively and at 1, 4 and 6 months after surgery.~      Details of postoperative chemotherapy and radiation will also be obtained from patient's~     notes and the electronic medical record. If the patient cannot follow up at the said~     intervals, the pain scores would be obtained telephonically and the BPI and PD-Q forms in~     prepaid envelopes would be given to them at discharge which they would have to duly fill in~     and post them to the given address at the appropriate intervals if they cannot visit the pain~     clinic. At the 6th month of follow up, they would be requested to visit the pain clinic for~     an assessment of MSTS score and completing the BPI and PD-Q.~      INCLUSION CRITERIA:-~        -  Adult patients above 18 years of age, undergoing TKR~        -  Literate: able to read and write in at least one of the following languages English,~          Hindi and Marathi~        -  Willing to fill forms and post them and/or answer questions on phone~      EXCLUSION CRITERIA:-~        -  Refusal of consent~        -  Cognitively impaired~        -  Revision TKRs (including cases with wound wash and nail spacer cementing)~   "
40800|NCT03032666|"~     Sustained Viral Response following 12-week therapy (SVR 12) with sofosbuvir/ledipasvir in~     transfusion-dependent patients with HCV genotype 1-6~      Secondary Objective(s):~      Assessment of transfusion requirements Adverse events Efficacy in treatment-naïve vs.~     relapsers vs. null responders Efficacy in patients with advanced fibrosis/cirrhosis vs. F1,~     F2 by elastography~   "
40801|NCT03032653|"~     This single-centre historical control group comparative study will compare outcomes of~     surgically-treated rotational ankle fractures and the current routine practice of early~     protected weightbearing and range of motion with immediate unprotected weightbearing as~     tolerated and range of motion after ankle open reduction and internal fixation.~   "
40802|NCT03032640|"~     The purpose of this study is to collect data to examine whether short-term consumption of~     non-caloric artificial sweeteners (NCASs), such as saccharin, can lead to changes in blood~     sugar levels and in the composition of the bacteria in the large intestine.~   "
40803|NCT03032627|"~     The purpose of the research is to help researchers understand changes in metabolism in~     patients that develop heart failure.~   "
40804|NCT03032614|"~     This is a phase II clinical trial of the combination of carboplatin, eribulin, and Veliparib.~   "
40805|NCT03032601|"~     Multiple Sclerosis (MS) is a disease in which the myelin surrounding the nerve cells is~     damaged which affects functioning. MS usually is treated with medications designed to reduce~     the occurrence of future MS events. Evidence suggests that an important part of the disease~     process is damage to the myelin and brain caused by too much oxygen (sometimes called~     oxidative stress) or too much inflammation (or swelling).~      The overall goal of this study will be to determine whether NAC will help to support cerebral~     function in patients with Multiple Sclerosis (MS). This PET-MRI study will utilize FDG PET to~     measure cerebral metabolism, along with MRI analysis, to measure metabolism and structural~     effects of NAC in patients with MS.~   "
40806|NCT03032588|"~     The main purpose of this study is to assess the safety and tolerability of a single dose of~     JNJ-64152348, inactivated poliovirus vaccine produced from Sabin poliovirus strains on PER.C6~     cells (sIPV) in healthy adults, using conventional inactivated poliovirus vaccine produced~     from Salk poliovirus strains (cIPV) as reference.~   "
40807|NCT03032575|"~     1. To determine the prevalence and incidence of anal HSIL and associated risk factors among~     MSM who initiate ART during AHI.~   "
40808|NCT03032562|"~     Using an extensive set of both volitional and non-volitional tests of respiratory muscle~     function and strength it is the aim of this study to~        -  identify disease-specific patterns of respiratory muscle impairment in different NMD and~          COPD~        -  establish which set of tests is predictive of sleep-disordered breathing or daytime~          hypercapnia in patients with NMD or COPD, respectively.~        -  to investigate the decline of respiratory muscle function in patients with progressive~          NMD and COPD along with sleep studies and capnography~   "
40809|NCT03032549|"~     This study will examine a Ready to Drink (RTD) supplement.~   "
40810|NCT03032536|"~     This is an open-label, randomized, multi-part study to evaluate the relative oral~     bioavailability of a tablet formulation of AL-3778 (formerly NVR 3-778) administered under~     fasted and fed conditions (Parts 1 and 2) and the drug-drug interaction between AL-3778 and~     entecavir or tenofovir disoproxil fumarate (Part 3).~   "
40811|NCT03032523|"~     Hypoglycemia is the most common metabolic problem faced after birth. The investigators will~     be studying the utility of using a continuous glucose monitoring(CGM) system to more closely~     monitor low blood sugars in newborns. The investigators will evaluate the number of~     hypoglycemic events detected using CGM and compare it to those detected using current~     standard of care screening methods.~   "
40812|NCT03032510|"~     The purpose of this study is to assess the efficacy, safety, and pharmacokinetics of~     eravacycline compared to ertapenem in treating participants with complicated urinary tract~     infections (cUTI).~   "
40813|NCT03032497|"~     The feasibility study proposed here will primarily examine the sensitivity of an~     electroencephalogram (EEG)-based Brain Computer Interface (BCI) in detecting significant~     differences in brain signals in patients with chronic low back pain (N=10), lower limb pain~     (N=10) and healthy controls (N=10) through perceived movements via a video and during actual~     movements. The BCI device has been approved for use in previous trials (e.g. NNI-IRB/07/001,~     DSRB Domain D/09/608, DSRB Domain D/10/072) and the safety and effectiveness of this~     non-invasive EEG-based BCI device validated through these trials. However, the validation has~     not been specific to its use in pain. Related to the primary objective of the study, we will~     develop and validate an adaptive and participant-specific pain detection and analysis program~     by exploring and identifying discriminative and robust patterns in spontaneous EEG from our~     study sample.~      For the secondary objective, we will develop and validate a BCI and computer based pain and~     attention diversion training system with interactive audio-visual feedbacks for Phase 2 of~     the study. These feedbacks will inform the user about the current brain activation level and~     attention level, and guide the user in learning to modulate the EEG characteristics and~     develop skills to manage attention to alleviate perceived fear-related pains. The BCI system~     captures EEG signals and decodes the underlying brain states in relation to cognition and~     fear-related pain perception. Such decoded brain states are then presented to the participant~     in visual or other form to guide the participant to learn to regulate the brain states~     towards better pain management. For example, the participant may over a few sessions learn to~     focus on the visual feedback while inhibiting the brain function activity in relation to~     fear-related pain perception. With practice, the user is encouraged to achieve brain activity~     modulation without external feedback so fear-related pain can be reduced in realistic~     situations.~   "
40814|NCT03032484|"~     Randomized phase 2 study TVB-2640 in combination with Bevacizumab versus Bevacizumab alone.~   "
40815|NCT03032471|"~     The primary objective of this multicenter observational study is to determine the effect size~     of the relationship between DCI and neuropsychological impairment 14-28 days and 3 months~     after aSAH.~      Secondary objectives are the feasibility to administer and the validity of the MoCA in an~     intensive care unit setting, as well as the test/retest reliability of the MoCA in patients~     with acute brain damage in absence of aSAH.~   "
40816|NCT03032458|"~     A randomised prospective trial comparing the efficacy of pethidine, Ketorolac, and Xylocaine~     gel as analgesics for pain control in shockwave lithotripsy.~   "
40817|NCT03032445|"~     Athletes who are participating in the Keys100 Ultramarathon event in Key West, FL are~     eligible, based on inclusion criteria, to participate in this research study that is seeking~     to determine whether supplementation of beer (alcohol) immediately following a long distance~     ultramarathon race can positively impact exercise-associated hyponatremia [EAH].~   "
40818|NCT03032432|"~     The purpose of this study is to determine if patients with shoulder pain and MRI-confirmed~     rotator cuff tendinosis, will have their pain and function improved when treated with daily~     use of a dynamic elastic garment along with a corticosteroid injection, when compared to~     those patients who receive a corticosteroid injection alone. To our knowledge this is the~     first study to evaluate the use of a dynamic elastic garment on shoulders.~        -  Group A: Control group, will receive and ultrasound-guided corticosteroid injection~          alone.~        -  Group B: Intervention, ultrasound-guided corticosteroid injection and scheduled use of a~          dynamic elastic garment.~      Up to 60 patients will participate and be randomized in this study, both male and female~     between the ages of 18 to 89 years of age. Subjects will complete a few forms; SF-36, ASES,~     Simple Shoulder test, these will take place at the initial visit and Then again at your 4~     week and 6 week visit.~      This is a single center study, investigator initiated. 60 subjects will participate in the~     study at Loma Linda University.~   "
40819|NCT03032419|"~     The trial is a phase III, non-inferiority, observer-blind, randomised, controlled,~     multicentre clinical trial with 2 parallel groups: IPV-Al SSI (investigational vaccine) and~     IPV SSI (reference vaccine)~   "
40820|NCT03032406|"~     To evaluate the feasibility of administering HCQ, EVE or the combination in patients who have~     completed primary therapy for breast cancer and harbor bone marrow disseminated tumor cells.~   "
40821|NCT03032393|"~     This study determines the effects of posture on time up and go test. Half of the subjects~     will assume a high-power posture, while the other half will assume a low-power posture.~   "
40822|NCT03032380|"~     To compare all-cause mortality at Day 14 in participants receiving S-649266 with participants~     receiving the comparator, meropenem, in adults with hospital-acquired bacterial pneumonia~     (HABP), ventilator-associated bacterial pneumonia (VABP), or healthcare-associated bacterial~     pneumonia (HCABP) caused by Gram-negative pathogens.~   "
40823|NCT03032367|"~     This is a randomized, open-label, cross-over study comparing the bioequivalence of~     bedaquiline administered in whole tablet form versus bedaquiline administered in crushed~     (experimental) form in healthy adult volunteers.~   "
40824|NCT03032354|"~     They are major genera of bacteria that make up the colon flora in human, constitute~     intestinal microbial homeostasis, inhibit growth of pathogens, improve the gut mucosal~     barrier and modulate local and systemic immune responses. Changes in gut microbiota can~     influence the immune system by increasing gut permeability, intestinal inflammation, and~     impaired oral tolerance in type 1 diabetes.Taken together, the data imply that~     bacteriotherapy may potentially be used as a tool to modulate the immune system for~     preventing islet destruction. Supplementation of Lactobacillus rhamnosus GG and~     Bifidobacterium lactis BB12 improved blood glucose control in normoglycaemic pregnant women~     and reduced the frequency of gestational diabetes mellitus~      Aim of the study:~      The effect of Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12 on beta-cell~     function in children with newly diagnosed type 1 diabetes: a randomized, double blind,~     placebo-controlled trial.~      Primary end point:~      Area under the curve (AUC) of c-peptide level during during fasting and at 30,60,90,120 min~     following the start of the meal~      Intervention:~      Included patients will be randomly assigned to receive a combination of Lactobacillus~     rhamnosus GG and Bifidobacterium lactis BB12 (Probiotics Group ) or placebo (Placebo Group )~     during six months.~      The expected results:~      Beneficial effect of Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12 on beta-cell~     function shown in the properly performed, methodologically accurate study would create a~     rationale for its routine use in patients with newly diagnosed type 1 diabetes.~   "
40859|NCT03031899|"~     Abstract~      Objective:~      To study the diagnostic efficiency of Rose Bengal with Toluidine blue in detecting the biopsy~     sites and thus establish an accurate diagnosis in oral premalignant lesions.~      Materials and method:~      In our study 27 patients with 41 lesions were included. Since one patient had not quit the~     habit in the two weeks following initial examination and another lesion disappeared in the~     waiting period, 2 patients (3 lesions) were not included in the study. Out of 38 lesions~     diagnosed based on clinical criteria, 32 were leukoplakia, 5 lichen planus and 1 SCC. After~     initial examination they were subjected to Rose Bengal and Toluidine blue stain. If stained~     positive they were subjected to biopsy.~   "
40825|NCT03032341|"~     The purpose of this research study is to find out if mobility (the ability to move around)~     can be reliably assessed by having the family or care giver caregiver take a video based test~     for the patient. If this study shows that mobility can be assessed by family or caregiver,~     this information can be used in situations where mobility cannot be measured directly in~     patients. A total of 60 patients and 60 family/caregivers at Wake Forest Baptist Medical~     Center will take part in this study. Patients physical function will be assessed using a test~     that uses short movie clips to assess mobility. Patients will be asked to watch ten short~     (~10 seconds each) movie clips that describe various tasks such as climbing up hills or~     walking and estimate if they can perform the tasks. The familymember/caregiver will be also~     asked to answer the questions on behalf of the patient. The family member/caregiver will be~     asked to return to take the same test in the next 1-14 days. The patient will be in the study~     for one day. There is no intervention, this is observational.~   "
40826|NCT03032328|"~     In previous work the investigator identified a group of children between the ages of 10-18~     years whose diagnostic workup for chronic nausea unexplained by conventional diagnostic tests~     has unexpectedly revealed underlying cardiovascular instability manifesting as orthostatic~     intolerance, primary defined as postural orthostatic tachycardia syndrome (POTS) (88%). While~     this is an atypical initial presentation for orthostatic intolerance in general, the~     investigator believes that the cardiovascular problem is serious and represents a cause of~     the nausea in a majority of these individuals, as treatment of the POTS with fludrocortisone~     reduced the symptoms of nausea. While fludrocortisone treatment abrogates the fall in~     baroreflex sensitivity (BRS) during tilt in part, it did not completely correct the~     tachycardia symptoms or the BRS suppression during HUT. Furthermore it caused an elevation in~     MAP in supine position, which may lead to future cardiovascular problems such as early onset~     hypertension and cardiac hypertrophy. This argues for a different treatment approach. The~     investigator presents preliminary data in this application revealing that OI subjects tend to~     have lower 25-hydroxy vitamin D (25(OH)D) compared to non OI subjects.~   "
40827|NCT03032315|"~     randomized, open-label, single dose, replicate crossover clinical trial to compare the~     pharmacokinetics of TAH(80/10/12.5) tablet in comparison to the co-administration of~     telmisartan, amlodipine and hydrochlorothiazide in healthy male volunteers~   "
40828|NCT03032302|"~     Traumatic brain injury (TBI) refers to neuronal damage occurring as the result of an external~     force being applied to brain tissue. In the United Kingdom annual figures (2013-2014) show~     449,000 hospital admittances with a diagnosis of head injury with males up to five times more~     likely to sustain a head injury than females. Traumatic brain injury (TBI) causes life-long~     disability, with no significant reduction in life expectancy, affecting a diverse range of~     cognitive and social functions including memory, task planning and execution, impulse~     control, social interactions, personality changes and depression. Following traumatic brain~     injury acquired deficits can lead to problems with resumption of aspects of daily life,~     particularly in terms of returning to work and interpersonal relationships.~      The initial injury triggers a secondary cascade of metabolic, neurochemical and cellular~     changes within the brain, primarily aimed at limiting damage and stimulating repair.~     Paradoxically prolonged secondary cascade mechanisms, including haemorrhage, oedema,~     neuroinflammation and axonal injury, results in exacerbation of deficits observed. The~     heterogeneous on-going nature of the secondary cascade presents clinicians with opportunities~     to intervene in an attempt to limit neuronal damage. A large body of nutritional research has~     been focused on addressing the hypermetabolic and catabolic states created by secondary~     cascade processes in the acute stage. Addressing these demands has played a significant role~     in reducing mortality and infection rates following head injury, however there has not been~     the same depth of research investigating the post-acute period (once individuals are~     discharged from hospital).~   "
40829|NCT03032289|"~     This study aims to investigate the association between active transport and the incidence of~     acute myocardial infarction in England.~   "
40830|NCT03032276|"~     Primary objective of the study is to measure the impact of a comprehensive package of~     interventions introduced by the Safe Motherhood Promotion and Newborn Survival project on~     neonatal mortality in three Upazila of Chandpur district, Bangladesh~   "
40831|NCT03032263|"~     Nasal intubation is frequently used for dental procedures to promote an unimpeded view of the~     oral cavity. A nasal RAE endotracheal tube is longer than a standard oral endotracheal tube~     (ETT) and it is shaped so that end of the tube which attaches to the ventilator exits upward~     toward the forehead. This unique shape ensures that the tube will not interfere with surgical~     exposure of the oral cavity and mandible. The nasal RAE ETT can be placed in the trachea~     using either direct laryngoscopy (DL) or video laryngoscopy (C-Mac) . Sometimes this is~     possible without an adjuvant, but frequently a pair of specially shaped forceps, known as~     Magill forceps, is required to guide the distal tip of the Nasal RAE into the glottis due to~     the curvature of these ETT. Magill forceps are introduced into the mouth and are used to~     grasp the distal end of the Nasal RAE and direct it into the glottis. Contrary to what the~     current literature suggests, it has been our experience that nasal intubations using the~     C-Mac frequently do not require the use of Magill forceps at nearly the same rate as DL. This~     technique may improve the time and ease to intubation because of not having to use the Magill~     forceps. The use of Magill forceps can be awkward for the clinician, with poor visualization~     due to obstruction of the view by this tool in the airway, and small working space within the~     posterior oropharynx. For these reasons, the possibility of not having to use Magill forceps~     because the investigators are using a C-Mac as the only tool to intubate is a potentially~     inviting one.~   "
40832|NCT03032250|"~     This pilot clinical trial studies how well Prepare to Care kit works in improving caregiver~     support in patients with stage I-IV head and neck cancer. Prepare to Care kit may increase~     knowledge about head and neck cancer and enhance stress-management skills.~   "
40860|NCT03031886|"~     Purpose: This study is carried out to determine the effect of GI on 24 hour blood glucose~     profiles and energy regulation in Asians when fed a normal diet modulated with sweeteners.~   "
40981|NCT03030313|"~     Assess the feasibility of using remote respiration rate monitoring as a component of home~     care, how respiration rate data may be used in combination with other data to potentially~     improve response to symptoms, and to generate data to inform the endpoints and effect sizes~     of future studies.~   "
40833|NCT03032237|"~     Rationale: Undernutrition risk among community-dwelling older adults in developed countries~     is shown to be around 24%. Increasing protein intake is a strategy that is feasible as well~     as efficacious to reduce undernutrition in community-dwelling older adults. A promising~     strategy to increase protein intake among older adults, is to offer dietary solutions with~     normal foods that fit their current daily eating patterns. For this reason, home-delivered~     protein-rich readymade meals and protein-rich dairy products will be studied in this~     research.~      Objective: The primary objective is to study the effectiveness of commercially available~     protein-rich readymade meals and protein-rich dairy products in increasing protein intake of~     older adults who use a meal-delivery service to a level of 1.2 g/kg bodyweight/d. Secondary~     objectives include: studying effects of these meals and dairy products on total daily energy~     intake. Further, studying the acceptance of and compliance to the meals and dairy products.~      Study design: The study will be performed as a single-blind randomized, controlled, four-week~     trial in a real-life setting: in community-dwelling older adults' own homes.~      Study population: The target group of this study are community-dwelling older adults who use~     a meal-delivery service.~      Intervention: Both groups will receive readymade meals for each day during 4 weeks. They will~     also receive dairy products to freely consume during the intervention period. The~     intervention groups receives protein-rich meals and protein-rich dairy products, the control~     receives standard meals and food products.~      Main study parameters/endpoints: Difference in daily protein intake between intervention and~     control group. Secondary parameters: energy intake and acceptance (liking).~   "
40834|NCT03032224|"~     The occurrence of dysphagia is a well-known early feature of esophageal cancer that may~     reduce caloric intake and thus cause weight loss. Sarcopenia is considered to be a~     consequence of such involuntary nutritional restriction. The prevalence of sarcopenia in~     patients with esophageal cancer before and after surgery is not well known and its possible~     consequences have been debated.~      Aim: The aim of this study was to prospectively explore body composition and function in a~     cohort of patients with esophageal cancer before and after surgery with curative intent. In~     particular, to investigate the prevalence and development of sarcopenia and body composition~     as a consequence to surgery for esophageal cancer and the possible relation to morbidity,~     length of stay and quality of life (QoL).~      Methods: In a cohort of 76 patients who had esophageal- or cardia-cancer and were planned for~     surgery with a curative intent, data on body-composition measured with bioimpedance, working~     capacity (cardiac stress test), grip strength and QoL (European Organisation for Research and~     Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ)-C30 version 3.0) were~     prospectively collected. Data regarding dysphagia was derived from an esophagus related~     quality of life form (EORTC QLQ-OES18). Data on tumour stage and type, complications, length~     of stay and preoperative weight loss were collected from medical charts.~   "
40835|NCT03032211|"~     1. Summary of Clinical Investigation~      A summary of the clinical investigation is provided below and includes the primary objective~     of the study, the safety and feasibility endpoints, the number of subjects to be enrolled,~     the study duration, the subject follow-up and the inclusion/exclusion criteria.~        1. Primary Objective~           The primary objective of the study is to evaluate the safety and feasibility of the~          alfapump® System indication for use in the management of fluid in NYHA Class III and~          ambulatory NYHA Class IV heart failure patients who have an eGFR of > 15 to < 60~          mL/min/1.73m2.~        2. Study Endpoints~             1. Primary Safety Endpoint~                The primary safety endpoint will be an assessment of the occurrence of adverse~               events (AEs) and serious adverse events (SAEs) related to:~                  1. Surgical implant of the alfapump®~                  2. Device malfunctions~                  3. Dialysate infusion~             2. Secondary Safety Endpoints~                The secondary endpoint will be an assessment of:~                  1. Time to first hospitalization related to fluid management after the activation~                    of the alfapump® System and initiation of dialysate infusion has occurred~                  2. Rate of occurrence of re-hospitalizations related to fluid management~                  3. All-cause mortality~             3. Assessment of Feasibility for Fluid Management in Heart Failure Indication The~               feasibility of the alfapump® System for management of fluid in NYHA Class III and~               ambulatory NYHA Class IV heart failure patients with renal dysfunction will be~               assessed by the net fluid balance as measured by the ability of the alfapump®~               System to move more fluid to the bladder than dialysate instilled.~   "
40836|NCT03032198|"~     Thyroid Feasibility Study~   "
40837|NCT03032185|"~     Introduction: Menopause is the last menstrual period, it is a natural phenomenon to all~     women. Postmenopausal, some women may experience unpleasant symptoms such as hot flushes,~     urogenital pain, headache and pains in the musculoskeletal system. That happens due to the~     decreased ovarian hormone secretion and changes in the autonomic system. Pain is also caused~     by a complex autonomic activity. For pain management, a therapeutic electrical stimulation of~     the peripheral nervous system promotes modulation of nociceptive incentives and release of~     endogenous opioids. According to reviewed studies, the use of transcutaneous electrical nerve~     stimulation (TENS), by directly stimulating the central nervous system, has presented results~     of manipulation of the autonomic system, being observed change in heart rate and cognitive~     improvement in dementia. Given this possibility, the present study aims to investigate~     whether the use of Transcutaneous Electrical Nerve Stimulation in low frequency can generate~     autonomic and psychophysical changes in healthy postmenopausal women.~      Objective: To evaluate the effectiveness of Transcutaneous Electrical Nerve Stimulation on~     autonomic and psychophysical parameters in postmenopausal women.~      Methods: randomized, crossover, double-blind. A sample of thirty patients will be selected~     according to inclusion and exclusion criteria previously established. The autonomic and~     psychophysical functions will be evaluated by Quantitative Sensory Testing and Conditioned~     Pain Modulation (pain thresholds to heat and modulation of conditioned pain, respectively),~     as well as scales to evaluate catastrophism and sleep quality (by scale of Pittsburgh Sleep~     Quality Index). After application of the scales, the participants will be subject to active~     Ttranscutaneous Electrical Nerve Stimulation session or sham with a fortnight washout as~     randomization. All the research subjects will be invited to participate in the study and sign~     an Informed Consent and Informed (ICI). This study will be registered in the Clinical Trials.~   "
40838|NCT03032172|"~     This is a multi-center, exploratory, non-comparative and open-label study to investigate the~     safety, tolerability, pharmacokinetic (PK) and PK/pharmacodynamic (PD) relationship of~     RO7034067 in adults and children with Type 2 and Type 3 Spinal Muscular Atrophy (SMA) who~     have been previously enrolled in a study with a survival of motor neuron 2 (SMN2)-targeting~     therapy.~   "
40982|NCT03030300|"~     To evaluate the long-term remission rate of short-term intensive insulin (STII) therapy in~     newly diagnosed type 2 diabetes outpatients and investigate the predictors contributing to~     the remission rate.~   "
40840|NCT03032146|"~     The aim of this study is to examine the contribution of a cardiac rehabilitation program on~     the active participation in daily life six months after an acute coronary event.~      100 patients will be recruited for the study, 3-10 months after a myocardial infarction and~     hospitalization in the Emek Medical Center in Afula, Israel.~      50 patients recruited for the study who had participated in cardiac rehabilitation will be~     the experimental group. 50 patients who have not participated in rehabilitation- will be the~     control group. The groups will be matched for diagnosis, sex and age. Sociodemographic data~     on patients will be taken from the medical records of the cardiology department and the~     Cardiac Rehabilitation Institute of the Emek Medical Center..~      Course of study: Participants will sign an informed consent form and fill out questionnaires~     that evaluate active participation in the community. In addition, the physical function and~     muscle strength of the participants will be evaluated with designated tests. The duration of~     each meeting will be 60 minutes.~      HYPOTHESES~        1. Patients who participate in a cardiac rehabilitation program will exhibit higher indices~          of participation in the community than patients who do not participate.~        2. Patients who participate in a cardiac rehabilitation program will display higher levels~          of physical activity when compared with patients who do not participate.~   "
40841|NCT03032133|"~     Patients are randomized to receive pain control after Total Knee Arthroplasty with either a~     regional pain catheter or a local intraarticular pain catheter. Pain, analgetic use and~     mobility is asessed.~   "
40842|NCT03032120|"~     This study aimed investigated the acute intake effect of fresh-squeezed orange juice (FOJ),~     processed orange juice (POJ), and an isoenergetic orange-flavored drink (control) on~     postprandial response of blood serum biomarkers (glucose, insulin, leptin and adiponectin),~     anti-oxidatant status, and prospective food intake in lean and obese subjects.~   "
40843|NCT03032107|"~     This research study is studying a combination of drugs as a possible treatment for metastatic~     breast cancer.~      The interventions involved in this study are:~        -  Pembrolizumab~        -  Trastuzumab emtansine (also called T-DM1)~   "
40844|NCT03032094|"~     The purpose of this study is to test if the thickness of the graft taken from the roof of the~     mouth, has a significant effect on the amount of attached tissue and the amount of root~     coverage that are attained when treating a single tooth with gingival recession.~   "
40845|NCT03032081|"~     The investigators will assess the efficacy and safety of utilizing high-intensity interval~     training in stable heart failure patients on functional outcomes. Specifically, an assessment~     of baseline peak oxygen uptake and peak cardiac output will be assessed before and 8 weeks~     after intense interval training. Measurements of quality of life will be assessed before and~     after training as well as the number of arrhythmic events before and after training. The~     control group will be a group that will follow a moderate exercise training protocol over a~     similar period.~   "
40846|NCT03032068|"~     Home monitoring technologies have recently emerged in many different areas of healthcare.~     These technologies are being used to provide rehabilitation to patients, and to prevent,~     identify, and manage complications. The investigators are proposing a method to monitor and~     communicate with patients during the first 12 weeks after total knee arthroplasty (TKA) using~     an electronic home-based patient monitoring system with unique connectivity capabilities and~     prescriptive controls. The investigators will prospectively, electronically capture range of~     motion and gait parameters at specified intervals using Bluetooth sensors worn by the~     patient. The unique in-home patient monitoring platform will be utilized by 10 TKA patients~     once they return home following surgery. The investigators hypothesize that the use of an~     internet based home patient monitoring technology platform will reliably provide information~     related to the patients' pain and function and enhance patient feedback and communication~     after TKA. The hypothesis will be tested with the following aim: 1) To test the reliability~     of all technology utilized within the patient's home including but not limited to the~     sensors, the communication controller, the patient interface (Android tablet) and the~     internet by prospectively comparing between data collected through the home monitoring~     technology and traditional clinical measurements taken during physical therapy and surgical~     follow-up visits.~   "
40847|NCT03032055|"~     Vaso-Occlusive Crisis (VOC), the most common manifestation of sickle cell disease (SCD), is~     the first cause of death, particularly when complicated by an acute chest syndrome (ACS).~      The PRESEV score could help the physicians to better manage VOC and could be used for future~     therapeutic trials. This predictive score of secondary ACS has to be validated in a~     multicenter international study.~   "
40848|NCT03032042|"~     Molecular testing of the gut microbiome and enteric pathogens is rapidly moving beyond~     targeted PCR testing to next generation sequencing techniques. In addition, the current state~     of monitoring for soil-transmitted helminth infections is moving increasingly from~     microscopic techniques to molecular techniques. The targeted PCR test for soil transmitted~     helminth diagnosis has been validated on stool samples, but not rectal swabs. Bulk stool~     samples are logistically challenging and time-intensive to collect, thus participation is~     often far from optimal. Rectal swabs are more efficient and may result in higher~     participation. In this study, children will be randomized to either albendazole,~     azithromycin, or both drugs, after which both rectal swabs and bulk stool samples will be~     collected. The investigators will compare the PCR test for soil transmitted helminth~     infections using both the rectal swabs and the bulk stool samples. In addition, the~     investigators will analyze the gut microbiome of the children using next generation~     sequencing techniques to gain insight into effects of mass drug administration.~   "
40849|NCT03032029|"~     The European ASV Registry (short name) will investigate the use of Adaptive Servo-Ventilation~     in non-heart failure conditions. The purpose is to examine the effects of ASV on quality of~     life, daytime symptoms and sleep, to describe usage patterns of ASV with regards to patient~     characteristics and to document adverse events related to therapy for a therapy safety~     analysis. A pilot phase will enrol at least 200 patients to test the feasibility of the~     registry. After the pilot phase will be completed and an intermediate data analysis had been~     performed, the registry will be expanded over several countries across Europe with the goal~     of enrolling up to 1000 patients over a period of 5 years.~   "
41265|NCT03026595|"~     Depression is considered to be the most common neuropsychiatric disturbance of PD. In this~     study, investigators will summarize the treatment profile of PD depression to see if PD~     depression is properly treated according to guideline.~   "
40850|NCT03032016|"~     Following the licencing of a new drug, Defitelio®, indicated for the treatment of severe~     Veno-Occlusive Disease of the liver (sVOD), a rare but serious complication of haematopoietic~     stem cell transplantation (HSCT), the pharmaceutical company that manufactures Defitelio®~     (Gentium, a Jazz Pharmaceuticals Company) - as a specific obligation (SOB) - has been~     required by PRAC (Pharmacovigilance Risk Assessment Committee) to set up a disease registry~     to collect safety and outcome data, and to assess patterns of utilization of Defitelio® in~     the post-approval setting. This registry is a Post Authorization Safety Study (PASS), which~     is being coordinated through the European Society for Blood and Marrow Transplantation~     (EBMT). Following appropriate consent, data from patients who undergo haematopoietic stem~     cell transplantation are routinely collected at the local centre for the EBMT database. For~     this study, the sites are being asked to collect additional anonymised clinical data from~     patients who develop this complication or who have been treated with Defitelio® for other~     reasons than sVOD. The study simply requires collection of data which is already recorded in~     the patient charts, but not routinely collected.~      The study DOES NOT involve decisions about treatment, which are clinical decisions, but~     merely collection of data for patients who develop this complication, whether or not they~     receive treatment and for patients who are treated with Defitelio® for any other reasons.~   "
40851|NCT03032003|"~     To investigate if oral administration of 240mg PAC of cranberries can reduce the number of~     episodes of acute bacterial cystitis and improve general QoL in women with recurrent~     bacterial cystitis. In addition, the effect on vagina and rectal flora will studied and the~     adverse effect profile of the drug will be reported.~      Women with ≥3 symptomatic episodes of lower UTIs at the previous year will be recruited from~     the outpatient population who present to their family physician or specialist with~     symptomatic recurrent UTI. Informed consent will be obtained from all patients and they will~     be divided in groups according to their age. Urinary culture, vaginal and rectal swab will be~     taken from all the patients. Antibiotic treatment will be prescribed (using the drug of~     choice according to the urine culture and the treating physician choice). Subsequently, they~     will be randomized to receive combined antibiotic treatment with one capsule of Cysticlean~     240mg PAC two times per day or antibiotic treatment with placebo. At 14th day post treatment~     and after a negative urinary culture patients will continue to receive per os, daily, one~     capsule of Cysticlean 240mg at bed time for 12 months or placebo respectively.~      Study visits will occur at 3rd, 6th , 9th and 12th month treatment phase. A urine collection,~     vaginal swabs and rectal swab will be taken at study entry and at the month 3, 6, 9 and 12~     visits.~      Participants will be asked about medication usage, any side effects they may be experiencing~     at each study visit. If participants develop a UTI at any time during the study, they will be~     asked to visit the study site within 24 hours.~   "
40852|NCT03031990|"~     Psychological stress and its sources differ among the population and can be reduced in~     various ways. The practice of yoga has been shown to be an effective stress reducing agent.~     IVF processes have also been shown to increase stress levels, particularly in patients with~     multiple failed IVF cycles. Less is known about stress levels in patients undergoing elective~     egg freezing for fertility preservation. The investigators demonstrated in a pilot project~     that yoga postures with a yoga focused discussion session decreases stress in infertility~     patients compared to controls. The goal of this study is to further explore the capability of~     yoga practice to reduce stress in a specific subset of infertility patients, those with a~     history of at least one failed IVF cycle and those undergoing elective oocyte~     cryopreservation. Additionally, the investigators are aiming to understand which aspect of~     the intervention (discussion vs. yoga) had the most impact and whether route of~     administration of the intervention (in person vs online) effects results.~   "
40853|NCT03031977|"~     The aim of the present study was to evaluate the effect of visceral mobilization on symptoms~     of functional constipation and static balance in stroke survivors.~   "
40854|NCT03031964|"~     This study will evaluate patients receiving a multihole revision acetabular implant for total~     hip arthroplasty (THA) and will be followed for 10 years to collect data on survivorship of~     the implanted prosthesis.~   "
40855|NCT03031951|"~     Given the lack of support for lifestyle management in post-career and considering the high~     rates of physical inactivity and overweight in former elite athletes, the aim of this~     research project is to analyze the efficacy and effectiveness of a lifestyle intervention in~     former athletes.~   "
40856|NCT03031938|"~     A4091065 is a multicenter, prospective, cohort study with enhance physical an~     neurodevelopmental surveillance to characterize the outcomes related to the development of~     infants up to the age of 15 months who were potentially exposed to tanezumab, placebo or~     comparator via maternal exposure or in utero in any tanezumb study.~   "
40857|NCT03031925|"~     There is substantial clinical and biological intra and inter-patient variability in SLE.~     Vascular, renal and neurologic deficiency can be organ-threatening or even life-threatening,~     leading to increased morbidity and mortality.~      Thus, biomarkers of disease activity and prognosis are required for regular follow-up of SLE~     patients.~      Implication of Toll-like Receptors (TLRs) in SLE has been extensively studied in mice models~     and humans. Self nuclear antigens bind to TLRs which are located on the surface of dendritic~     cells, B-cells, and endothelial cells, leading to production of pro-inflammatory cytokines~     and pathologic autoantibodies involved in organ dysfunction of SLE patients. Moreover, TLR~     expression in SLE is significantly higher and significantly correlated with disease activity.~      Annexin A2 (ANXA2) is a member of the annexins superfamily which exists as a monomer or~     heterotetramer and is implicated in several biological processes. Most notably, it binds to~     ẞ2GP1/anti-ẞ2GP1 antibodies and mediates endothelial cell activation via a TLR4 signaling~     pathway, highlighting its key role in Antiphospholipid Syndrome (APS) frequently associated~     with SLE.~      ANXA2 is also involved in the physiopathology of SLE. Anti-DNA autoantibodies can bind with~     ANXA2 expressed on mesangial cells in lupus nephritis. Besides, a french study carried out in~     Amiens' University Hospital showed that vascular lesions in lupus nephritis were associated~     with a significant increase in vascular expression of ANXA2.~   "
41105|NCT03028701|"~     The overall objective is to asses the bronchodilator effect of single dose of~     Formoterol/Budesonide 12/400 mcg fixed combination delivered via Discair® in patients with~     COPD.~      Spirometric measurements (FEV1, FVC) will be performed for a period of 12 h at 12 different~     times: pretreatment (prior to the first dose) and posttreatment (15. min, 30. min, 1 hr, 2~     hr, 3 hr, 4 hr, 5 hr, 6 hr, 8 hr, 10 hr ve 12 hr).~   "
40861|NCT03031873|"~     Brain arteriovenous malformations are abnormal communications between brain arteries and~     veins with an intervening tangle of abnormal arteries (nidus). Brain AVMs may be asymptomatic~     or symptomatic, presenting with acute hemorrhage or neurological symptoms. Brain AVMs that~     have not bled carry a yearly risk of intracranial hemorrhage of approximately 4% (Ondra et~     al.).~      The management is multidisciplinary involving neurosurgeons, interventional~     neuroradiologists, radiation physicians, neurologists and allied health care personnel.~     Patients may be treated with open neurosurgery, endovascular embolization, radiation therapy~     or any combination of these treatments. The goal of the treatment is to eliminate the brain~     AVM while preserving normal flow to the surrounding normal arteries. This involves~     obliteration of the shunting of blood via the AVM arteries to veins by a variety of~     treatments. The treatment regimen is individualized dependent on natural history, the~     angioarchitecture, location, risk of treatment(s) and patient wishes.~   "
40862|NCT03031860|"~     Cough strength score will give true prediction of Extubation outcome~   "
40863|NCT03031847|"~     This pilot will enroll 50 HF patients (age ≥ 75 years) undergoing CRT device implantation at~     the hospitals of the University of Pittsburgh Medical Center, Duke University, Ohio State~     University, and the VA Pittsburgh Healthcare System. Patients will be randomized to CRT-P~     versus CRT-D and followed until study end. Rates of patient screening, enrollment,~     randomization, and retention as well as cost of care will be examined. The results of this~     pilot study will inform the design of a large pivotal non-inferiority trial and will be~     necessary for its success. Patients who refuse participation in the randomized pilot trial~     will be asked to enroll in a prospective observational cohort. Characteristics of patients~     who choose CRT-P vs. CRT-D will be compared and patients' level of satisfaction with their~     device decision will be measured.~   "
40864|NCT03031834|"~     Patients with diabetes mellitus and definite autonomic and peripheral neuropathy were~     randomized to receive quinapril or no treatment for 2 years.~   "
40865|NCT03031821|"~     This is a multi-centre, double-blind, randomized phase III trial comparing metformin to~     placebo in patients with advanced prostate cancer starting intermittent androgen deprivation~     therapy.~   "
40866|NCT03031808|"~     When a surgical procedure is performed under general anesthesia, the Airways are often~     secured With an endotracheal tube. Some patients experience sore throat thereafter. Studies~     have shown a reduction of these side effects when by use of muscle relaxants or a lidocain~     spray prior to the intubation. At Ostfold Hospital Trust, the investigators use one of the~     two methods or nothing. These methods will be studied systematically.~      Heart rate and blood pressure rise during the intubation procedure. The investigators will~     also study the differences between the groups.~   "
40867|NCT03031795|"~     Ketorolac is a non-steroidal anti-inflammatory drug (NSAID), similar to ibuprofen but it is~     used to treat more severe pain. Ketorolac (Trade name: Toradol) is typically used after~     surgical procedures. When taken orally, it should not cause sedation. The purpose of this~     study is to determine if oral ketorolac is effective at reducing pain during IUD placement~     versus a placebo tablet.~   "
40868|NCT03031782|"~     This is a double-blind, placebo-controlled, event-driven randomized withdrawal study to~     investigate the efficacy and safety of secukinumab treatment in the Juvenile Idiopathic~     Arthritis (JIA) categories of Juvenile Psoriatic Arthritis (JPsA) and Enthesitis-related~     Arthritis (ERA). The study is divided into 3 parts (plus a post-treatment follow-up period)~     consisting of open-label, single-arm active treatment in Treatment Periods 1 and 3 and a~     randomized, double-blind, placebo controlled, event-driven withdrawal design in Treatment~     Period 2.~   "
40869|NCT03031769|"~     An observational, multinational, cross sectional study to describe 24-hs symptoms, physical~     activity and their relationship in stable COPD patients in Europe~   "
40870|NCT03031756|"~     The aim of this clinical study was to evaluate the clinical efficacy of using perio flow~     adjunctively with mechanical instrumentation on periodontal parameters and halitosis.~      Sixty patients who presented with 4-6-mm probing pocket depth (PPD) were recruited for the~     study. Patients were randomly assigned to glycine powder air-polishing (GPAP) or control~     groups. For both groups PPDscores were recorded at the baseline and 1 month. Volatile sulphur~     compound (VSC) values were measured by a halimeter at the baseline, immediately after~     treatment, and at 7 days, 14 days and 1 month.~   "
40871|NCT03031743|"~     This is a nested case-control study within an ongoing rotavirus vaccine immunogenicity trial~     in Karachi, Pakistan. The primary study aim is to compare the fecal microbiota composition~     and diversity of infants who do (control) and do not (case) demonstrate immune seroconversion~     to rotavirus vaccination. The infants will be matched for vaccination dose, age and~     breast-feeding practices.~   "
40872|NCT03031730|"~     This phase I trial studies the side effects and best dose of MDM2 inhibitor AMG-232 when~     given together with carfilzomib, lenalidomide, and dexamethasone in treating patient with~     multiple myeloma that has come back of has not responded to previous treatment. Drugs used in~     chemotherapy, such as MDM2 inhibitor AMG-232, carfilzomib, lenalidomide, and dexamethasone,~     work in different ways to stop the growth of cancer cells, either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading.~   "
40873|NCT03031717|"~     Portal vein thrombosis (PVT) is defined as an obstruction of the portal vein. The prevalence~     of PVT is 10-25% and incidence is about 16% in cirrhotic patients. PVT leads to increased~     intrahepatic resistance, decreased portal velocities, splanchnic vasodilatation, and stagnant~     flow.~      Portal vein recanalization (PVR) with transjugular intrahepatic portosystemic shunt (TIPS) is~     aimed at restoring main portal vein (PV) flow in chronic PVT. In this study, we will review~     the safety and outcomes of this approach.~   "
40885|NCT03031561|"~     This clinical trial studies a new type of ultrasound technique, MicroPure, in detecting~     breast microcalcifications in patients undergoing biopsy for a breast abnormality. Ultrasound~     sends sound waves into the body, and the sound waves reflected back are interpreted by the~     machine into a grayscale image. MicroPure uses a filter that adjusts the brightness and gives~     color to the ultrasound images, which may allow doctors to better identify~     microcalcifications. Microcalcifications are tiny deposits of calcium in the breast that~     cannot be felt but can be detected by imaging. A group of microcalcifications may indicate~     that cancer is present.~   "
40874|NCT03031704|"~     Sporadic duodenal adenomas are rare. As they are highly pre neoplastic, they should be~     removed and endoscopic mucosectomy is recommended during digestive endoscopy. However, this~     technique, albeit less dangerous than surgery, is associated with complications such as~     haemorrhages, perforations, and more relapse than that can be observed for colorectal~     adenomas. As no prospective data have been published this French multicenter study aim to~     analyze results of this technique under standardized and secured procedure.~      All investigators are expert in therapeutic endoscopy in tertiary centers and are member of a~     group of clinical researcher involved in that field ( GRAPHE  (Groupe de Recherche et~     d'Action des Praticiens Hospitaliers en Endoscopie interventionnelle). Results are highly~     expected among the international society of gastroenterologists who need to confirm the~     efficacy of endoscopy and define optimal conditions for performing adenomas resection in this~     location Primary End Point is the two years recurrence rate. Secondary End Points are~     frequency and type of complication after standardized endoscopic mucosectomy of duodenal~     adenomas, frequency and type of complications after a second endoscopic mucosectomy and~     patient's characteristics Patients with sporadic duodenal adenomas larger than 5 mm requiring~     endoscopic mucosectomy will be included. Non-inclusion criteria concern patients with~     previous endoscopic resection, lesion involving the major papilla, sub mucosal lesions,~     familial adenomatous polyposis and use of antiplatelet agent during the five last days.~      Hundred and twenty patients will be included and followed 2 years after mucosectomy.~   "
40875|NCT03031691|"~     A Phase 1b Dose Escalation Study of the Safety and Pharmacodynamics of Brontictuzumab in~     Combination with Chemotherapy for Subjects with Previously Treated Metastatic Colorectal~     Cancer.~   "
40876|NCT03031678|"~     The MED-EL EAS Extended Follow-up Study is an extended follow-up of the subjects who were~     enrolled in the pivotal study to assess long-term safety and device performance.~   "
40877|NCT03031665|"~     Using an innovative multi-modal imaging approach, this study investigates the role of the~     neurochemical gamma-aminobutyric acid (GABA), brain activity, as well as hormones in~     understanding sex differences in Major Depressive Disorder (MDD). Further, the investigators~     will link these markers to symptoms of depression.~   "
40878|NCT03031652|"~     Charts of 142 patients who underwent standard phacoemulsification under topical anesthesia~     between March and August 2016 were reviewed. The pain during phacoemulsification and 1 h~     after surgery was assessed and compared using a visual analog scale.~   "
40879|NCT03031639|"~     The endoscopic thyroidectomy approach is gaining popularity in the surgical field. This~     registry tries to collect the outcomes including quality of life and complication for both~     endoscopic and conventional thyroidectomy methods.~   "
40880|NCT03031626|"~     The aim of this study is to determine if treatment with Medical Air (21% oxygen in room air)~     compared to supplemental oxygen (100% oxygen) will lead to similar improvements in the~     central apnea-hypopnea index (CAHI) for infants with Prader-Willi Syndrome.~      Despite the vast amount of research investigating the cause of central sleep apnea, there~     remain gaps in knowledge, lending to further research efforts. The decision to compare oxygen~     to medical air is based on several theorized mechanisms. The first of which is the~     supposition that provision of medical air may act as an arousal stimulus for the~     hypothalamus, thereby preventing sleep disordered breathing. Secondly, the hypercapnic~     challenge performed by Livingston et al demonstrated a delayed hypercapneic arousal response~     in PWS subjects despite simultaneous hyperoxia, leading us to question if therapeutic oxygen~     really plays a significant role in treating CSA. Lastly, the delivery of medical air via~     nasal prongs may provide sufficient arousal to terminate the cycle of events leading to~     central apnea, as described by Urquhart et al.~      A deeper understanding of central sleep apnea is essential to ameliorating its adverse~     sequelae, which include symptoms of ADHD, impaired attention, behavioral problems, and~     academic difficulties.~   "
40881|NCT03031613|"~     To investigate the effects of positive end-expiratory pressure (PEEP) on the intracerebral~     pressure (ICP) and intraocular pressure (IOP) in patients undergoing robot assisted~     laparoscopic radical prostatectomy (RALRP)~   "
40882|NCT03031600|"~     The objective of this study is to determine the accuracy of estimating patient blood volume~     using field-expedient point-of-care measurement of hematocrit before and after hemodilution~     with a standardized volume of intravenous solution, in comparison to determining patient~     blood volume by radiodilution. A total of 33 healthy adult male subjects aged 18-35 years~     will undergo determination of blood volume in a fixed order: first by radiodilution, then by~     hemodilution. Blood volume as measured by radiodilution will be correlated with blood volume~     as estimated with hemodilution to assess the potential validity of hemodilution as means of~     estimating blood volume.~   "
40883|NCT03031587|"~     Radiofrequency ablation is the primary treatment for atrial and ventricular arrhythmias~     resistant to medication. However, the absence of assessment of injury creation during~     radiofrequency application is an important issue. One of the objectives of the Institut~     Hospitalo-Universitaire (IHU) Liryc (l'Institut de Rythmologie et Modélisation Cardiaque) is~     to improve ablation procedures by radiofrequency of cardiac arrhythmias. This is based on~     thermometric imaging by Magnetic Resonance Imaging (MRI) which allows a real time~     visualization of tissue temperature in all the myocardium with sufficient spatial and~     temporal resolution to characterize the induced thermal lesion. Today, investigators have~     developed and validated a new method for cardiac thermometry, associating rapid MRI~     acquisition technique (4 to 5 slices per heart beat) with online image reconstruction and~     correction algorithms against residual motion, magnetic susceptibility, drift of the magnetic~     field, etc... Recent preclinical studies showed a precision of 1°Celsius in the myocardium,~     largely sufficient to characterize a thermal treatment induced by radiofrequency where~     typical temperature rises of 40°C are observed during ablation. Temporal evolution of the~     temperature in each pixel provides access to calculation of the accumulated thermal dose that~     is a relevant indicator of the induced necrosis.~      This imaging method must now be evaluated in humans in order to test its robustness under~     real conditions (presence of arrhythmias, corpulent patients, etc…) and to optimize~     acquisition parameters and image processing. The aim of this research is thus to obtain~     specific MRI sequence of images of patients, on which will be evaluated the different~     algorithms of reconstruction and processing for temperature imaging. This study is a~     mandatory step in the perspective of future clinical treatments of cardiac arrhythmia under~     MRI.~   "
40884|NCT03031574|"~     The purpose of the study is to evaluate the effect of food, gender, and age on the~     single-dose pharmacokinetics (PK) of SUVN-D4010.~   "
40886|NCT03031548|"~     Chest X-ray and/or fluoroscopy is not routinely used in the OR to confirm endotracheal tube~     (ETT) placement by anesthesiologists. Multiple studies have shown that ~19% of all~     intubations result in inappropriate ETT placement. An adult study has shown that ultrasound~     point-of-care is superior to auscultation in determining the location of ETT. This study aims~     to determine if point-of-care is useful in determining ETT position in children.~   "
40887|NCT03031535|"~     The purpose of the study is to investigate the drug octreotide acetate in a new intranasal~     formulation and compare it to the FDA-approved subcutaneous (SC) injection formulation. The~     two octreotide acetate formulations will be evaluated following separate administrations for~     safety and tolerability including any side effects, the speed at which the drug is absorbed~     and eliminated in the body, and the ability of the drug to lower the levels of growth hormone~     (GH) and insulin-like growth factor 1 (IGF-1).~   "
40888|NCT03031522|"~     The investigators developed 18F-IRS as a targeted molecular imaging agent for noninvasive and~     repeatable detecting EGFR-activating mutational status.~   "
40889|NCT03031509|"~     The purpose of this study is to evaluate the efficacy and safety of human amniotic epithelial~     cells transplant in nonunion of limb fracture patients.~   "
40890|NCT03031496|"~     The combination of the diuretics amiloride hydrochloride (HCl) and hydrochlorothiazide (HCTZ)~     (GSK3542503) is indicated for the treatment of hypertension, congestive heart failure and~     hepatic cirrhosis with ascites and edema. This first time in human (FTIH) study is aimed to~     determine whether the test product GSK3542503 is bioequivalent to the reference (ref)~     hydrochlorothiazide 50 milligram (mg)/amiloride hydrochlorothiazide 5 mg in healthy adult~     participants under fasting conditions based on pharmacokinetic (PK) endpoints. This is a~     phase I, open label, balanced, randomized, single dose, two-way crossover study, enroling~     approximately 42 healthy participants at a single center. Study participants will be~     randomized to one of two treatment sequences (A-B or B-A) in accordance with the~     randomization schedule. A single dose of one of the two treatments A (Test: GSK3542503, a~     hydrochlorothiazide 50 mg and amiloride hydrochloride 5 mg fixed dose combination) or B~     (Reference: Moduretic, a hydrochlorothiazide 50 mg and amiloride hydrochloride 5 mg fixed~     dose combination), will be administered on Day 1, in each treatment period. Each participant~     will participate in both treatment periods and receive a single dose of each treatment. The~     treatment periods will be separated by a washout period of at least 7 days and no more than~     14 days. The total duration in the study for each participant is expected to be 5 to 7 weeks,~     from screening to his or her last visit. A maximum of 42 participants will be randomized such~     that at least 32 evaluable participants complete the study.~   "
40891|NCT03031483|"~     Patients with lymphoid tissue lymphoma mucosa-associated (MALT) for which the standard~     treatments with radiotherapy, chemotherapy and / or immunotherapy show lack of efficacy~   "
40892|NCT03031470|"~     Liver transplantation is currently the treatment of choice for end-stage liver cirrhosis of~     different origin, as well as for a number of inborn metabolism disorders and liver tumors.~     The need to perform a liver transplantation is high and amounts to 10 - 20 patients per 1~     million population per year.~      Experimental and clinical evidence demonstrate the harmful short and long-term effects of~     ischemia-reperfusion injury (IRI) of the donor organ on the outcome of the intervention~     performed. Severe manifestations of IRI of the liver transplant (LT) is one of the main~     reasons for the increased length of hospitalization, the high cost of treating patients~     during the post- surgery period, the development of persistent early allograft dysfunction or~     loss, frequent crises of acute rejection, acute renal and multiple organ failure, and~     mortality of the operated patients.~      This pilot clinical study is designed to evaluate the efficacy and safety of Reparixin, which~     is a new, potent and specific inhibitor of chemokine CXCL8 (Interleukin-8), as an agent to~     prevent early allograft dysfunction caused by ischemia-reperfusion injury in patients~     undergoing orthotopic liver transplantation.~   "
40893|NCT03031457|"~     Venous thromboembolism (VTE) encompasses pulmonary embolism (PE) and deep venous thrombosis~     (DVT) and continues to be a major patient safety issue after reconstructive plastic surgery.~     Significant morbidity and mortality is associated with VTE events. This disease entity~     represents the most common cause of preventable in-hospital death as evidenced by over~     100,000 annual VTE-related deaths in the U.S. The associated economic burden is substantial,~     with annual costs to the U.S. healthcare system in excess of $7 billion.~      Cancer patients have been identified as a particularly vulnerable patient population. Of~     these, breast cancer patients represent the largest group treated by plastic surgeons. An~     increasing number of breast reconstructions are performed in the U.S. with a documented 35%~     increase in the annual number of breast reconstructions since 2000. Over 106,000 breast~     reconstructions were performed in 2015 alone.~      Of all reconstructive modalities, autologous breast reconstruction using abdominal flaps is~     associated with the highest risk for VTE. We believe that a key element rendering these~     patients susceptible to postoperative VTE is inadequate duration of chemoprophylaxis. This is~     supported by the observation that VTE risk remains elevated for up to 12 weeks~     postoperatively. We hypothesize that lower extremity deep venous system stasis is a~     procedure-specific key contributing factor to postoperative VTE risk.~      This study examines the duration of postoperative lower extremity venous stasis to identify~     patients who might benefit from extended chemoprophylaxis. We will use Duplex imaging~     technology to examine the lower extremity deep venous system preoperatively, on postoperative~     day 1, and on the day of discharge to determine if patients display radiographic evidence of~     lower extremity venous stasis at the time of hospital discharge.~      A better understanding of pathophysiologic mechanisms that contribute to the development of~     VTE as well as surgical means that reduce VTE risk factors have the potential to optimize VTE~     prophylaxis, thus, favorably impacting clinical outcome in a large patient population.~   "
40894|NCT03031444|"~     This study was designed to analyze the prognosis and recurrence predictive factors of high~     risk patients (Clinical Risk Score≥3) of resectable colorectal liver metastasis.~      The efficacy of perioperative chemotherapy plus cetuximab and chemotherapy alone was compared~     for these patients.~   "
40895|NCT03031431|"~     Hypothermia contributes to a significant portion of neonatal deaths. Kangaroo mother care~     (KMC) is a safe and effective method of warming; however, it is not always feasible, and not~     possible in settings such as resuscitation or clinical instability. Electric warmers are the~     standard of care in developed countries, but are extremely costly, complicated with risk of~     causing both hypo and hyperthermia with misuse, and often not feasible in settings without~     stable electricity. Through a multi-institutional collaboration, the investigators have~     developed an electricity-free infant warmer. After laboratory based prototype testing for~     safety and efficacy, the investigators aim to study the supervised use of the warmer under~     routine implementation conditions in a resource-limited setting.~   "
40896|NCT03031418|"~     The purpose of this research study is investigate a new and validated urine test which~     predicts the likelihood of high grade prostate cancer on an initial prostate biopsy The~     current protocol has two objectives; one is to further assess and evaluate the performance of~     the urine test in men already scheduled for initial prostate needle biopsy (cohort (group) 1)~     and two, to evaluate how the results of the urine test influences the decision process for~     determining whether to perform a prostate biopsy (cohort (group) 2).~   "
40897|NCT03031405|"~     The purpose of the study is to examine whether oxytocin and oxytocin receptor gene~     polymorphism affect the development of intrusive memories, a cardinal symptom of PTSD.~   "
40898|NCT03031392|"~     Bleeding on probing demonstrated to have high specificity with certain level of sensitivity~     to detect periodontal disease. Again, understanding the weak hemidesmosome attachment to the~     implant surface is imperative to discern on the probe penetration extent and subsequent~     bleeding. In the presence of inflammation, bleeding should be present indicating high~     sensitivity when probing deeper sites; nevertheless the lack thereof in healthy condition~     does not seem to translate high specificity. In this sense, it is noteworthy to mention that~     the mucogingival shift after implant placement often decreases the presence of keratinized~     mucosa, triggering a greater inflammatory condition on the peri-implant tissues. Thereupon,~     bleeding on probing, although might reliably indicate presence of disease, it does not seem~     to be a suitable diagnostic parameter. On the other side, suppuration characterizes the~     necrosis of peri-implant tissues, being rich in polymorphonuclear cells and as such, a~     sensitive indicator of bone turnover. In this sense, it must be noted that, if detected in~     early stages where bone resorption has not occurred yet, it might be a consequence of a~     foreign body reaction (i.e., residual cement or floss).~      Therefore, in the diagnosis of peri-implantitis, radiographic examination must be always~     incorporated to the clinical assessment as the 'gold standard'. Hence, the aim of this~     case-control study was to assess the diagnostic accuracy of peri-implantitis-related clinical~     parameters compared to otherwise healthy dental implants.~   "
40899|NCT03031379|"~     Randomized controlled trial assessing the safety and benefits of shortening preoperative~     fasts on intubated ICU patients undergoing tracheotomy.~   "
40900|NCT03031366|"~     TIPS creation has been widely used to treat the complications associated with portal~     hypertension. In association with increased operator experience and the ongoing development~     of imaging modalities, the rate of major complications associated with TIPS has decreased~     significantly in the past decades. However, the passage of a curved needle from the hepatic~     vein into the portal vein still remains a challenging and time-consuming part of the~     procedure and is associated with puncture-related complications that are potentially~     fatal.Three-dimensional roadmap guidance has been widely applied in various interventions.~     The aim of the present study is to prospectively assess the feasibility and efficacy of~     real-time 3D roadmap guidance during TIPS creation.~   "
40901|NCT03031353|"~     Neonatal respiratory distress may occur in either term or preterm newborns with a higher~     relative risk in preterm, and whether born vaginally or through caesarean section, but in a~     higher percentage after elective caesarean section whose rate is rising.~      Prostaglandins may be given about one hour before an elective caesarean section after~     excluding the presence of contraindication to their use to decrease the neonatal respiratory~     diseases and thus, the number of children who suffered from bronchopulmonary dysplasia that~     occurs frequently in children who had previously TTN will diminish.~   "
40902|NCT03031340|"~     To see if the administration of 3 dosses of pregabalin (1 dose preoperative, 2 doses~     postoperative) will reduce the postoperative opiate requirements of patients undergoing~     spinal fusion surgeries of two or more vertebrae.~   "
40903|NCT03031327|"~     A 2 week randomized (1:1:1), controlled, double-masked, parallel group, pre-market study.~      Patients with ocular discomfort following refractive surgery procedure (within 6 months from~     enrollment into the investigation) will be evaluated at baseline (Day 1), at Week 2 (day 15±2~     days) and at Week 3 follow-up visit (day 22±2, or early exit).~   "
40904|NCT03031314|"~     Barbed suture use has been gaining increased acceptance and has been reported to offer~     potential advantages in wound closure of hip and knee replacement surgeries.~      The goal of this study is to compare joint replacement patient outcomes who receive a~     knotless barbed suture versus a traditional suture (randomized into two arms). The~     traditional suture used at our joint replacement program is defined as: interrupted sutures~     to close the retinaculum followed by running monocryl sutures for skin closure. Both knotless~     barbed suture and the traditional sutures have similar suture size.~      Patient outcomes examined will be patient range of motion (recorded daily) and complications~     with wound healing (evaluated periodically in-person at post-operative visits).~      Secondary outcomes examined will include wound drainage on dressings by surface area and~     weight, as well as the wound cosmesis and perceived presence of subcutaneous surgical knots.~   "
40905|NCT03031301|"~     The study is a prospective, adaptive, multicenter, randomized, double-blind, Sham-controlled~     study, to evaluate the efficacy and safety of the Vibrant Capsule in relieving constipation~     in subjects with functional constipation.~      Two arms will be assessed:~        -  Vibrant Capsule administered 5 times per week~        -  Sham Capsule administered 5 times per week~      Subjects will follow a 2 weeks baseline period and then take the Vibrant Capsule for a~     treatment period of 8 weeks.~      Data reporting will be done on an electronic Case Report Form (eCRF) and an eDiary.~      Subjects will be asked to refrain from taking any medication or supplement to relieve their~     constipation, during the entire study period.~      After the 14 days of run-in period, the subjects will return and eligibility will be~     re-assessed. Subjects will be trained on how to use the base unit and will swallow the first~     capsule on site the day of baseline visit. They will activate and ingest the rest of the~     capsules at home by themselves, using the base unit.~      Subjects will be instructed to complete a simple subject eDiary each day throughout the~     duration of the study. A final visit will take place at the end of the 8 week treatment~     period.~      Subjects will receive phone calls at least once a week and subject compliance will be~     monitored during the 8 weeks of the study.~   "
40906|NCT03031288|"~     Aim of the study is to evaluate the effects of vented base bottles on respiration-swallow~     patterns and on gastroesophageal refluxes in preterm infants with clinical suspect of~     gastroesophageal reflux disease (GERD).~      In this crossover-randomized study, we compared the effects of standard feeding bottles (A)~     versus vented base feeding bottles (B) on a group of patients with at least 2 clinical GERD~     symptoms. 24 hours of synchronized cardiorespiratory (CR) and Esophageal Multichannel~     intraluminal impedance (MII/pH) monitoring were evaluated for each patient. During this~     period, patients were fed alternatively with feeding bottle A and B.~   "
40907|NCT03031275|"~     Follow-up after treatment with Extracorporeal Membrane Oxygenation (ECMO) at the ECMO Center~     Karolinska.~      Patients: adult survivors treated with ECMO for severe refractory respiratory failure at~     least 5 years earlier.~      Investigations: brain and pulmonary radiographic morphology, cognitive testing, pulmonary~     function testing, exercise tolerance, quality of life and mood disorder screening.~   "
40910|NCT03031236|"~     Background (brief):~        1. Burden: The uniqueness of each child is tremendously influenced by interaction between~          nature and nurture during critical period of brain development that promotes foundation~          of brain architecture through neuronal connections.~        2. Knowledge gap: Young children in Bangladesh are prone to multiple physiological and~          psycho-social risk factors e.g. poverty, maltreatment, malnutrition, disease, parental~          illiteracy, maternal depression and lack of stimulation, all of which are preventable.~          Little is reported about any comprehensive package of development that addresses most of~          these early childhood risks and promotes optimum early childhood development (ECD).~        3. Relevance: The aim of this study is to develop and evaluate an integrated, low cost, and~          feasible center based approach that focuses on positive parenting of children during~          early life that will promote early stimulation, minimize childhood maltreatment, boost~          up of maternal self-esteem and healthy thinking and improve health and nutritional (HN)~          status of children.~      Hypothesis (if any):~      This integrated intervention will promote maternal child-care practices and mental health~     that will finally improve their children's growth, micro-nutrient status, early brain~     development compared to control group.~      Objectives:~      To see the effect of an integrated intervention (ECD + HN) on growth, micro-nutrient status,~     child development along with effect on maternal child-care practices and mental health.~      Methods:~      Randomly selected 2 groups will be identified as intervention and control (150 mothers'~     from15 clusters in each group). Mothers of 8-23 months old children living in slums and~     practice harsh child-disciplining will be identified as study population. The mothers of~     intervention (ECD+HN) group will receive fortnightly group sessions for 11 months that will~     include combined messages on a) psycho-social stimulation, b) positive parenting to prevent~     child maltreatment and c) cognitive behavioral therapy (CBT) for positive thinking, d) health~     and nutrition messages and e) 15 micro-nutrient sprinkle supplement.(90 sachets of over 6~     month-period). The control group will only receive the usual health messages provided by the~     government.~      Outcome measures/variables:~        -  Children's cognitive, motor, language and socio-emotional development; anthropometry;~          hemoglobin and micro-nutrient status (serum vitamin B12, iron and folic acid)~        -  Mother s' parenting practices, depressive symptoms, self-esteem and child-maltreatment.~   "
40911|NCT03031223|"~     Spinal cord injuries have become increasingly frequent due mainly to the increase in urban~     violence. The growing number of automobile collisions and violence-related events merits~     particular attention, as such occurrences can lead to death or disability stemming from a~     spinal injury. The severity of the consequences depends on the location affected and degree~     of destruction of afferent and efferent spinal cord pathways, with higher, more extensive~     injuries leading to less physical fitness and functional independence. Unfortunately, injured~     neurons of the central nervous system are unable to regenerate following a spinal injury and~     spinal cord regeneration is therefore a major challenge to researchers in the fields of~     neuroscience and neurologia. Upon receiving an external stimulus, the central nervous system~     is believed to adapt and reorganize itself using mechanisms to compensate for neuronal loss~     and promote, even if partially, the remodeling of remaining synaptic connections, leading to~     new neuronal sprouting. Low-level laser therapy (LLLT) has proven to be a possible option for~     the stimulation of the repair process in the central nervous system. It is plausible that~     this type of therapy can offer the same benefits previously established in other types of~     tissues, the stimulation of bone formation, neovascularization and the regeneration of~     peripheral nerves. Research groups have investigated the efficacy of LLLT for the treatment~     of spinal cord injuries and have demonstrated that laser therapy administered simultaneously~     to an injured sciatic nerve and corresponding segment of the spinal cord accelerates the~     regeneration process of the injured peripheral nerve.~   "
40912|NCT03031210|"~     The aim of this study will be to evaluate whether a twice-daily antibiotic regimen is~     non-inferior to a thrice-daily regimen for the treatment of non-severe community acquired~     pneumonia in children presenting at a paediatric Emergency Department (ED).~   "
40913|NCT03031197|"~     The small RCT will assess feasibility, acceptability, and impact of a real-time intervention~     on ART adherence and clinical outcomes for HIV-positive adolescents. All subjects will use a~     wireless pill container (WPC) to monitor adherence. Intervention subjects will receive a~     personalized triggered reminder (cellphone message/call or bottle-based flash/alarm) when~     they miss a dose, and engage in monthly counseling sessions informed by their adherence data.~     Comparison subjects will receive usual care and an offer of counseling at monthly clinic~     visits.~   "
40914|NCT03031184|"~     This clinical trial evaluates whether Mirtazapine or Carbamazepine are more effective than~     placebo in treating agitation in people with dementia. The trial will assess the safety,~     clinical and cost effectiveness of each treatment. Participants will be randomised to receive~     one of the treatments for 12 weeks and will be followed up for up to one year, in this~     blinded trial.~   "
40915|NCT03031171|"~     The goal of the project is to increase colorectal cancer screening within the priority~     population of female and male adults age 50 to 85 in Northern Nevada. A successful~     community-based cancer patient navigator program will be modified in partnership with the~     community into a multi-level screening intervention.~   "
40916|NCT03031158|"~     Low back pain (LBP) is extremely common in older adults and is associated with a host of~     negative consequences, including decreased physical function and increased healthcare~     utilization. Among older adults with LBP, hip impairments indicative of hip joint disease are~     more prevalent and associated with greater disability than among older adults without LBP.~     This study will investigate a novel intervention designed to improve LBP-related disability~     by combining a typical spine-focused exercise program with a hip-focused intervention.~   "
40917|NCT03031145|"~     The purpose of this pilot study is to evaluate allergen-induced nasal airway inflammation~     following nasal application of felis domesticus, or cat, extract in e-cigarette users,~     cigarette smokers, and non-smokers.~   "
40918|NCT03031132|"~     The purpose of this study is to examine the effects of breakfast skipping (SKIP) vs. the~     consumption of a high protein solid (HP-S) breakfast vs. the consumption of a high protein~     beverage (HP-B) breakfast on daily appetite control, food cravings, food intake, and sleep~     quality in young adults.~   "
40919|NCT03031119|"~     Part A will investigate the safety, tolerability, PK and PD of PF-06835919 administered for~     14 days in a multiple ascending dose design. Part B will assess the effect of PF-06835919~     co-administration at low and high doses on the PK of atorvastatin in a single cohort.~   "
40920|NCT03031106|"~     The aim of this study is to adjust and test an existing internet-based tool for collecting~     patient-reported outcome measures and to use the internet-based tool in an multidisciplinary~     follow-up of patients treated for malignant hematological diseases. The patient-reported~     outcome measurements will be used in describing the patients' health-related quality of life~     (HRQoL) and to investigate whether the HRQol will increase due to participation in~     multidisciplinary follow-up.~   "
40921|NCT03031093|"~     This study has the objective to clarify the factors that directly influence the effectiveness~     of inhaled drug deposition in obese patients with chronic obstructive pulmonary disease~     (COPD) and suggest the use of High Flow Nasal Cannula (HFNC) during their inhalation therapy.~   "
40923|NCT03031067|"~     One of the major challenge in the field of organ transplantation is the shortage of donor~     organs. Many patients waiting for organ transplantation die during the waiting time and many~     patients wait for organ transplantation many years with a detrimental effect on their quality~     of life, and increasing morbidity and the costs related to. Effective strategies, which~     safely extends the donor pool, are therefore advocated. During the last 20 years the two main~     policies to gain this purpose were the living donation and the utilization of extended~     donor's criteria (ECD). These donors are supposed to yield a lower outcome than the~     conventional donors and many research protocols were developed to reduce the preservation~     injury (PI) and PI-related complications. Static cold storage (SCS) has been the standard~     technique in clinical practice for liver and kidney preservation using particular solutions~     (Wisconsin, Custodiol and Celsior) able to prevent cellular swelling. Recently, graft~     preservation with hypothermic machine perfusion (HMP) is developing, because it seems to~     improve early graft function due to increased tissue ATP concentrations upon reperfusion and~     due to the continual flush of the microcirculation which removes waste products.~      The addition of oxygen during the perfusion represents an innovation in the methods of~     preservation in approved clinical setting seems to add further improvements of the graft. The~     present study was designed in order to assess the impact of hypothermic oxygenated perfusion~     (PIO) of marginal human kidney and liver compared with SCS.~   "
40924|NCT03031054|"~     Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with~     involving compression of the median nerve in the carpal tunnel. Rather than other progressive~     disease, CTS is characterized by remission and recurrence. The hydrodissection could decrease~     the entrapment of nerve to restore blood supply. In addition, the hyaluronic acid was proved~     to decrease adhension of soft tissue and nerve during operation. The investigators design a~     randomized, double-blind, controlled trial to assess the effect after ultrasound-guided~     hydrodissection with hyaluronic acid in patients with CTS.~   "
40925|NCT03031041|"~     Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with~     involving compression of the median nerve in the carpal tunnel. Rather than other progressive~     disease, CTS is characterized by remission and recurrence. The hydrodissection could decrease~     the entrapment of nerve to restore blood supply. Despite the hydrodissection was pervasively~     used in clinical practice, current researches contain small participant without control group~     or randomized leading to foreseeable selection bias. The investigators design a randomized,~     double-blind, controlled trial to assess the effect of different method of ultrasound-guided~     hydrodissection in patients with CTS.~   "
40926|NCT03031028|"~     This study will consider the effectiveness of the ketogenic diet (high-fat, low-carbohydrate,~     and moderate protein) in treating epilepsy. Investigators enroll a group of eligible~     epileptic children and adolescent who have been referred from epilepsy center to our clinic~     and prescribe them ketogenic diet.~   "
40927|NCT03031015|"~     To introduce a novel external-fixation technique using the combination of K-wires and cement.~     For comparison, we also included another group of patients who were treated using a mini~     plate and screw system. Bone healing, range of motion of the fingers, costs of treatments,~     and patient satisfaction were assessed.~   "
40928|NCT03031002|"~     Patients with anxiety disorders oftentimes express fear responses to more than only one~     fear-inducing object. The principal aim of this study is to examine whether the beneficial~     effects of exposure on fear reduction in spider phobia can extend to stimuli which are~     conceptually similar to spiders (i.e. cockroaches), but have never been presented during the~     respective treatment.~   "
40929|NCT03030989|"~     This study evaluates the use of 2% CHG washcloths in an outpatient setting for adults after~     hematopoietic stem cell transplant in prevention of central line associated blood stream~     infections. Half of the participants will use 2% CHG washcloths and other half will use~     placebo washcloths.~   "
40930|NCT03030976|"~     CAR-T therapy was therefore proposed and has been recently used for cancer treatment. It has~     been hailed for its promising remission rates after early stage clinical trials for acute~     lymphoblastic leukemia. However, CAR-T therapy is seldom used for autoimmune diseases.~     Researchers only use it for the treatment of multiple sclerosis (MS, an autoimmune disease of~     the central nervous system). SLE is a kind of autoimmune diseases which involving multiple~     systems, organs and with the present of a variety of autoantibodies. In the conventional~     treatment options, SLE could be treated with chemotherapy drugs or hormone drugs. But~     chemotherapy and hormone drugs could barely cured SLE. And now, chimeric antigen receptor~     modified T cell infusion maybe an effective treatment to solve these problems. The~     investigators use a 2nd CAR- T with the optimized hinge and transmembrane domain to treat~     patients with SLE. The purpose of this study is to assess the safety and efficacy of this 2nd~     CAR-T cells in the treatment of SLE.~   "
40931|NCT03030963|"~     Ventilator mode change was associated with decrease in blood loss during posterior lumbar~     interbody fusion (PLIF) due to decrease in the peak inspiratory pressure (PIP). The purpose~     of this study was to determine the effect of equal ratio ventilation (ERV), which sets the~     I:E ratio of the ventilator to 1:1 during volume controlled ventilaiton, on surgical blood~     loss during PLIF. Investigators hypothesized that ERV would decrease surgical blood loss due~     to decrease in the PIP.~   "
40932|NCT03030950|"~     This study is designed to explore the effects of peri-neural dexmedetomidine on the duration~     and motor sparing potentials of adductor canal block in adult patients undergoing~     arthroscopic medical meniscectomy in the setting of multimodal analgesia. The investigators~     ultimate goal is to increase the postoperative analgesic time and to preserve quadriceps~     muscle strength to promote safe and early ambulation.~   "
40933|NCT03030937|"~     The purpose of this study is to determine whether apatinib plus irinotecan can improve~     progression free survival compared with single irinotecan in patients with advanced gastric~     cancer or adenocarcinoma of esophagogastric junction who failed one lines of chemotherapy.~   "
40934|NCT03030924|"~     This study is prospectively enrolling a cohort of adolescent patients who present to the~     Emergency Department with acute suicidality.~   "
40935|NCT03030911|"~     The aim of this study is to compare the effect of dexmedetomidine on resting energy~     expenditure in relation to the midazolam in critically ill patients using indirect~     calorimetry~   "
40936|NCT03030898|"~     The idea of this work came during a carotid surgery, when we noticed a respiratory variation~     of the right internal jugular vein. Also, because of the interest of evaluating the preload~     dependence during an intervention or reanimation where it is difficult to access the other~     monitoring methods . The aim of the study was to test the hypothesis that respiratory changes~     in right internal jugular vein diameter are similar to respiratory changes in superior and~     inferior vena cava in mechanically ventilated patients and therefore help to predict fluid~     responsiveness.~   "
40937|NCT03030885|"~     The main purpose of this study to determine the safety of an experimental medicine called~     131I-MIP-1095. 131I-MIP-1095 is an investigational drug, meaning it has not been approved by~     the U.S. Food & Drug Administration (FDA).~   "
40938|NCT03030872|"~     The objective of this study is to compare the diagnostic value of MR DSC-Perfusion (Perfusion~     Module), MR DWI (Diffusion Module) and MR DTI (Diffusion Module) in CARESTREAM Vue PACS~     (investigational device) to the Olea Sphere PACS with Perfusion and DWI Modules (predicate~     device). Therefore, there will be several separate objectives depending on the type of~     acquisition:~   "
40939|NCT03030859|"~     This randomized pilot clinical trial studies how well the self-care program works in head and~     neck cancer survivors with lymphedema and fibrosis. A self-care program may promote self-care~     activities for managing chronic swelling and tough/tight tissues in the head and neck region.~   "
40940|NCT03030846|"~     The purpose of this study was to evaluate the effects of stabilization exercises on pain,~     disability and pelvic floor muscles function in patients with lumbopelvic pain.~   "
40941|NCT03030833|"~     The purpose of the study is to assess device performance in the presence of carbon monoxide.~   "
40942|NCT03030820|"~     This will be a prospective study of cirrhotics and healthy controls comparing their oral~     microbiota, endotoxemia and systemic inflammation at baseline and at 30 days after clinically~     indicated systematic oral cleansing and interventions as well as 3-month hospitalizations~     post-cleaning.~   "
40943|NCT03030807|"~     The investigation serves the identification of pulmonary hypertension (PH) among patients~     with hypersensitivity pneumonitis (HP). The exact prevalence of PH in HP is unknown. Data~     from South America indicate that the prevalence of pre-capillary PH amongst patients with HP~     is higher than 20%. There are no reliable data from Europe so far. According to the~     investigators previous analysis, more than 400 HP patients have participated in pulmonary~     rehabilitation at least once in the past 10 years at Klinikum Bad Gleichenberg~     (Rehabilitation Center for Agricultural Workers in Austria). This collective of patients is~     to be invited to participate in the study.~      A diagnostic algorithm will be applied in the clinical trial, in the case of clinical~     suspicion the diagnosis of PH will be confirmed by right heart catheterization. Besides the~     determination of the prevalence of PH in patients with HP the investigators aim to assess the~     reliability of non-invasive methods (e.g. Echocardiography, ECG...) to predict PH.~   "
40944|NCT03030794|"~     This study aims to assess the effect of repetitive transcranial magnetic stimulation (rTMS)~     on Gulf War illness related headaches and pain.~   "
40945|NCT03030781|"~     Specific and objective guidelines for choosing endobronchial tube size for main-stem~     intubation in pediatric patients are lacking. The objective criteria for choosing an ETT size~     for OLV are likely to increase the safety and success. The primary aims of this study were to~     define the relationship between cricoid and mainstem bronchi (right and left) in children of~     various ages and to determine the effects of age, height and weight.~   "
40946|NCT03030768|"~     The greatest burden of the HIV-1 epidemic lies in sub-Saharan Africa, where a substantial~     proportion of infections occur in long-term heterosexual HIV-1 serodiscordant partnerships.~     Such couples face a difficult dilemma when considering their desire to have children: forego~     condom use, attempt to conceive and risk HIV-1 transmission or continue condom use and~     relinquish their childbearing desires. Based on evidence from rigorous clinical trials~     demonstrating the strong efficacy of individual interventions for HIV-1 prevention and~     formative work with HIV-1 serodiscordant couples and clinicians with expertise in HIV-1~     prevention and reproductive health in the Kenyan context, this study pilots a safer~     conception intervention that focuses on antiretrovirals (as antiretroviral therapy [ART]~     taken by the HIV-1 infected partner and pre-exposure prophylaxis [PrEP] taken by the HIV-1~     uninfected partner) and timed condomless sex. Additional strategies for couples include~     diagnosis and treatment of STIs and male circumcision.~      mHealth tools, including SMS and mobile applications are novel and very popular among Kenyans~     to ease the burden of addressing health problems. This safer conception intervention~     incorporates mHealth tools to improve couples' experiences tracking fertility indicators and~     communicating with providers about their readiness to practice safer conception. SMS surveys~     to collect daily information from women about their fertility signs and SMS messages are used~     to reinforce HIV-1 prevention, including condom use for couples during periods that do not~     have a high likelihood of fertility. An in-clinic mobile application is used to improve~     clinician-patient counseling and assessments of couple readiness to practice safer~     conception. To inform future engagement of mHealth tools, the investigators will~     prospectively evaluate clinician and patient experiences using SMS surveys and the tablet~     application. Couples with immediate fertility intentions will be followed longitudinally,~     allowing careful tracking of pregnancy and HIV-1 incidence. The study takes place in Thika,~     Kenya.~   "
40947|NCT03030755|"~     The goal of this research is to develop measurement tools and simulation technology for~     characterizing and predicting individual responses to corneal treatments and for advancing~     understanding of corneal ectasia risk factors. Patients who either 1) have keratoconus and~     are being evaluated for corneal crosslinking or 2) have refractive error and are being~     evaluated for refractive surgery procedures such as LASIK will have their eyes imaged to~     assess their mechanical properties and will have computational simulations performed to~     predict the response to treatment. One aim of the study is to test the hypothesis that~     computational models can predict the cornea's shape changes within clinically acceptable~     limits of error.~   "
40948|NCT03030742|"~     This study seeks to investigate the prescribing patterns and patient utilization of opioid~     pain medication in the postpartum setting. Postpartum women will be surveyed prior to~     hospital discharge and again at 2-4 weeks postpartum in order to assess the number of opioid~     tablets they used (in relation to the number prescribed), pain satisfaction, and~     storage/disposal of any remaining opioid tablets.~   "
40949|NCT03030729|"~     Comparison between retinal measurements, done by the RT (Retinal Thickness) imaging and a~     commercial OCT (Optical Coherence Tomography)~   "
40983|NCT03030287|"~     The purpose of this study is to test the efficacy and safety of an experimental drug,~     OMP-305B83, when given in combination with paclitaxel. OMP-305B83 is a humanized monoclonal~     antibody and was developed to target cancer stem cells. Based on preclinical studies, it is~     believed that OMP-305B83 may block the growth of cancer stem cells and may also impair the~     productive growth of new blood vessels, which tumors need to grow and spread.~   "
40950|NCT03030716|"~     Tannins are known to inhibit iron absorption through formation of insoluble tannin-mineral~     complexes, and have thus been termed 'antinutritional.' Despite this, there is evidence that~     adaptation to similar antinutritional factors is possible when consumed over time.~     Limitations in current studies include short (single meal) duration, and use of incongruent~     tannin types from the condensed tannins that are commonly consumed. If adaptation to tannins~     does happen, it may be due to salivary proline-rich proteins, which have been found to be~     protective of iron status in animal models. The primary objectives of this study are: 1) To~     determine whether condensed tannins impact iron bioavailability or status when consumed in~     multi-dose, multiple daily supplements and 2) to test whether salivary protein production may~     impact iron bioavailability with tannin supplementation. Secondary objectives included~     assessment of the reliability of astringency as a measure of salivary protein production and~     iron absorption.~      The study has been conducted in an iron absorption study of 11 women, aged 18-35 years old,~     to determine iron bioavailability with supplementation of 0.03, 0.25, and 1.5 g 95%~     proanthocyanidin rich grape seed extract before and after regular, three times daily~     supplementation for four weeks. Each participant consumed all three concentrations of~     supplement over the 26-week study, with a two-week washout between interventions. Direct iron~     absorption was measured using area under the curve. Iron status was measured by changes in~     hemoglobin and ferritin, and was adjusted by participant c-reactive protein levels. Salivary~     samples were collected before and after supplement consumption during meal challenges, and~     analyzed on HPLC. Astringency testing was conducted at the end of each meal challenge. Iron~     absorption and status markers were analyzed by ANOVA, and mixed-modeling followed by pairwise~     comparison by least significant differences. Pearson's correlations were used to correlated~     salivary proteins and astringency with iron bioavailability.~      The present study will provide important information regarding the approximate influence of~     condensed tannin consumption on iron bioavailability and storage over time, at different~     doses. Data will also help to delineate possible physiological mechanisms underlying tannin~     adaptation and possible ways to detect individuals who better adapt than others.~   "
40951|NCT03030703|"~     Phytic acid is a known inhibitor of iron bioavailability, although long term studies have~     suggested possibly exaggerated findings compared to single meal studies, pointing to phytic~     acid adaptation over time. Salivary proline-rich proteins have been found to reduce~     tannin-iron chelation, but studies have not explored changes in salivary proteins that may~     result in phytic acid adaptation. The primary objectives of this study are: 1) To determine~     whether phytic acid impacts iron bioavailability or status when consumed over time 2) to test~     whether salivary protein production may impact iron bioavailability with phytic acid~     supplementation, and 3) to explore in vitro phytic acid salivary binding. Secondary~     objectives included assessment of the reliability of astringency as a measure of salivary~     protein production and iron absorption.~      The study was conducted in an iron absorption study of 7 women, aged 18-35 years old, to~     determine iron bioavailability with supplementation of 350 mg phytic acid before and after~     regular, three times daily supplementation for four weeks. Direct iron absorption was~     measured using area under the curve. Iron status was measured by changes in hemoglobin and~     ferritin, and was adjusted by participant c-reactive protein levels. Salivary samples were~     collected before and after supplement consumption during meal challenges, and analyzed on~     HPLC and by ELISA. Astringency testing was conducted at the end of each meal challenge. In~     vitro saliva-phytic acid modeling was explored on HPLC, MALDI-TOF, and ELISA. Iron absorption~     and status markers were analyzed by ANOVA, and mixed-modeling followed by pairwise comparison~     by least significant differences. Pearson's correlations were used to correlated salivary~     proteins and astringency with iron bioavailability.~      The present study will provide important information regarding the approximate influence of~     phytic acid consumption on iron bioavailability and storage over time in regards to salivary~     proteins. It will also give context to the role of salivary proteins with phytic acid~     consumption over time. Data will also help to delineate possible physiological mechanisms~     underlying phytic acid adaptation and possible ways to detect individuals who better adapt~     than others.~   "
40952|NCT03030690|"~     This study will evaluate the clinical performance of glass carbomer cement restorations in~     restoring proximal lesions in primary molars compared to that of resin modified glass ionomer~     cement and composite resin restorations. Teeth will be randomly assigned to one of the three~     restoration groups and the restorations will be evaluated clinically and radiographically~     every six months.~   "
40953|NCT03030677|"~     The investigators are trying to establish an easy technique for insertion of a catheter for~     continuous infusion while performing pectoral type 2 (serratus) block, as a post operative~     pain controlling measure for cases undergoing simple mastectomy, using ultrasound guidence~   "
40954|NCT03030664|"~     A randomized, multicenter, placebo-controlled, double blind study in two parallel groups~     testing the efficacy of daily oral supplementation with the probiotic L.reuteri DSM17938~     compared to placebo in increasing the number of spontaneous bowel movements in infants and~     children with functional constipation.~   "
40955|NCT03030651|"~     The purpose of this study is to develop and test Breastfeeding Education and Support~     Intervention for improving timely initiation and Exclusive Breastfeeding rate.~      Infant mortality rates are still high in Ethiopia. Breastfeeding (BF) is regarded as the~     simplest and least expensive strategy for reduction of infant mortality rates. Ethiopia does~     not meet the international recommendation for exclusive breastfeeding (EBF) for the first six~     months of life. Community-based educational and support interventions provided prenatally and~     postnatally are effective in increasing BF rates. However, there is paucity of such~     information in Ethiopia.~   "
40956|NCT03030638|"~     This study aims to characterise the use of single-agent olodaterol and single-agent~     indacaterol, the only marketed LABAs authorised for COPD, but not for asthma, in clinical~     practice.~   "
40957|NCT03030625|"~     The aim of this study was to determine the efficacy and safety of the implementation of a~     program of  image-guided focal Intensification dose to intraprostatic dominant lesion  in~     men with localized prostate cancer (PCa) of intermediate and high risk (criteria NCCN)~     eligible to receive radiotherapy in the Department of Radiation Oncology of HUP within the~     established dose escalation protocol with intensity modulated image-guided radiotherapy (IMRT~     / IGRT).~   "
40958|NCT03030612|"~     The purpose of this Phase I/II study is to investigate the safety and tolerability (Phase I)~     and the efficacy/clinical benefits (Phase II, proof-of-concept) of ARGX-110 in combination~     with standard doses of azacytidine (AZA) in subjects with previously untreated acute myeloid~     leukemia (AML) or high risk myelodysplastic syndrome (MDS) who are eligible for AZA~     treatment.~   "
40959|NCT03030599|"~     This is a double-blind, placebo-controlled, randomized-withdrawal, multicenter study of the~     efficacy and safety of JZP-258.~   "
40960|NCT03030586|"~     The objective of the ADDIA clinical Proof-of-Performance study is to validate the performance~     of ADDIA' blood biomarkers for diagnosis of Alzheimer's disease.~      ADDIA clinical study is a multi-centre, non-interventional, prospective, proof-of-performance~     study with only one visit.~      About 800 well-characterized subjects will be recruited into 3 groups in 2:1:1 ratio, namely~     patients with Alzheimer's disease (AD), patients with non-AD neurodegenerative disease (NAD)~     and 200 control subjects (healthy as compared to their age).~        -  400 patients with Alzheimer's disease (AD): 200 patients with mild AD, 200 patients with~          moderate-to-severe AD,~        -  200 patients with non-Alzheimer's neurodegenerative diseases (NAD),~        -  200 controls (healthy as compared to their age).~   "
40961|NCT03030573|"~     The investigators developed a new surgical technique in order to reconstruct the bile duct~     with the round ligament~   "
40962|NCT03030560|"~     Spinal fusion is a painful surgery, and control of postoperative pain is difficult. Several~     studies have indicated that appropriate pain treatment protocols reduce postoperative~     morbidity, improve the results of the surgery, and decrease hospital costs~   "
40963|NCT03030547|"~     To evaluate physical activity levels and factors associated with physical activity levels in~     adult patients with muscle diseases.~   "
40964|NCT03030534|"~     The purpose of this study is to adopt an operational research approach that seeks to design,~     develop and pilot-test the health-promotion lifestyle model that will enhance~     health-promoting behaviour and lifestyle modification of university staff in Nigeria. The~     following are the hypotheses of the study:~        1. There will be a significant difference in the pre and post intervention practices of~          health promoting lifestyle behaviours (behaviour specific cognition and affect) of NOUN~          staff~        2. There will be significant association between the health promoting lifestyle behaviours~          (behavioural outcome) and health status of NOUN staff~        3. There will be a significant difference in the pre-and post-intervention health promoting~          lifestyle behaviours (behavioural outcome) of staff of NOUN~        4. There will be a significant difference in the pre-and post-intervention health status~          measure (specific health measurement indicators) of staff of NOUN~   "
40965|NCT03030521|"~     Aortic dissection is defined as the separation of aortic medial lamellae. It is unknown why~     some aortic dissection are limited in extent while other aortic dissection extend~     extensively. The investigators hypothesize that the medial layers are separated as a result~     of the uneven dilation and dislocation of the inner and outer layers, and if this hypothesis~     is ture, dilation is necessary to the development of aortic dissection. In this study, an in~     vitro experiment was performed to test whether dilation is essential to the development of~     aortic dissection.~      Participants will be recruited from patients with aortic repair surgery in Wuhan Asian Heart~     Hospital. A piece of aortic wall will be dissected to reconstruct aorta during operation.~     Firstly, the dissected aortic wall is sampled for routine pathological examination. Secondly,~     the remaining tissue is cut into a 2cm by 2cm sheet, then an incision was made on the inner~     surface of the tissue sheet. The outer 0.5mm media will not be incised. Thirdly, the tissue~     sheet is used to seal a hole in a syringe with the incision faced inside, and tissue sheet of~     the experimental group was bound by a band to restrict its dilation in the next step.~     Fourthly, the syringe is filled with blue stain, and a mechanical test is performed. Fifthly,~     for the experimental group, the band is removed, and the syringe is filled with red stain.~     The mechanical test is performed again. Finally, the tissue sheet is released and cut into~     several parts to show whether the inner and outer media layers are separated by the blue~     stain or the red stain.~   "
40966|NCT03030508|"~     At present, chemotherapy is widely used in the adjuvant treatment of colorectal cancer~     patients after surgery. Capecitabine is one of the main chemotherapeutic drugs. But the~     effect is not good enough, the adverse reaction is serious, and the individual differences~     were significant. The present study shows that these problems are related to the differences~     in the exposure of capecitabine and its metabolites in different patients. The genetic~     biomarkers for capecitabine include DRD, MTHFR and TYMS. Mutations in these genes directly~     affect the expression of metabolic enzymes involved in capecitabine and control the~     concentration of capecitabine and its metabolites. However, these markers have been obtained~     through clinical trials in the United States, and their role in predicting the effectiveness~     or safety of capecitabine and its metabolites has not been validated in Chinese cancer~     patients.The study was based on a case study of patients with colorectal cancer in China, and~     capecitabine as the primary postoperative chemotherapy regimen to verify whether the~     available biomarkers can be used to predict the effectiveness and safety of capecitabine. To~     clarify the effect of capecitabine on endogenous metabolites, and to study the mechanism of~     its effect, so as to discover new biomarkers.~   "
40967|NCT03030495|"~     1. To compare the risk of atherosclerotic lesion progression and subsequent~          patient-oriented composite outcomes (all-cause mortality, any MI, or any Ischemia-driven~          repeat revascularization) between deferred lesions with or without over microvascular~          disease, defined as physiological classification~        2. To explore independent predictors of atherosclerotic lesion progression in deferred~          lesions based on fractional flow reserve-guided strategy and treated by contemporary~          medical treatment~   "
40968|NCT03030482|"~     Anxiety is a common problem encountered in a about 43 % of critically ill patients. Its~     occurrence can be related to several causes, mainly dominated by invasive procedures.~      anxiety management is typically based on a combination of prevention, evaluation, and~     therapeutic agents. However, it appears important to develop adjuvant approaches. Touch~     massage is one of them and that has been evaluated in various medical conditions.~      The aim of our study is to evaluate the anxiolytic effect of touch massage in critically ill~     patients during potentially painful nursing procedures.~   "
40969|NCT03030469|"~     The goal of this research is to investigate the impact of changing opioid analgesic~     prescribing defaults on the quantity of opioids prescribed for acute non-cancer pain in adult~     dentistry settings. We will change prescribing defaults for select short-acting opioid~     analgesics including immediate release oxycodone and hydrocodone as well as codeine and~     tramadol, including their co-formulations with acetaminophen. In a cluster-randomized trial~     of three Montefiore Medical Center dentistry sites, we will evaluate the impact of this~     intervention on patient-level outcomes using 18 months of data (6 months pre-intervention and~     12 months post-intervention).~   "
40970|NCT03030456|"~     This study is a randomized clinical trial that has as objective to evaluate the effects of~     training with a vibratory platform on body composition, muscular strength functional~     capacity, flexibility and biochemical profile on elderly women. It will be done in the city~     of Santa Cruz do Sul, Rio Grande do Sul, with elderly women between the ages of 60 and 80~     years-old, within the municipal limits and nearby areas selected randomly by a brown envelope~     in which a note will be stating if they belong to the control or vibratory platform group, in~     which the participant will be receiving whole body vibrations on the platform. The recruiting~     will be done by the institution through e-mail or by public call.~      Women will be evaluated through anamesis. On the evaluation, a questionaire will be applied,~     in order to evaluate if they don´t have counterindications for the vibratory platform. They~     will be evaluated in their general health, socio-economical status, and history of physical~     activity. Participants will have their doubts cleared about the study, and a written consent~     will be signed. Before the intervention with whole body vibrations, nutritional and physical~     activity aspects will be evaluated. The treatment period on the vibratory platform will be of~     8 weeks, before and after it, anthropometrical, biochemical, strength, flexibility, palmar~     prehension strength, metabolic basal load, and functional capacity measurements will be~     taken. Before and after every session on the vibratory platform, heart rate, respiratory~     rate, arterial pressure, and peripheric oxygen saturation will be evaluated. The~     interventional procedure will be done with a vibratory platform (Power Plate®, model my7™,~     UK) with a frequency of 30 - 40 Hz, with low (2mm) or high (4mm) amplitude. Training will~     last 8 weeks with 3 sessions per week, lasting between 30 seconds and 1 minute of training,~     and 30 seconds to 1 minute of rest, with the subject positioned in orthosis with a knee~     flexion of 15° and a feet width distance of 20 cm. The frequency will be of 35 Hz and the~     amplitude of 2 mm.~      The study aims to contribute with reducing the body mass index and body fat percentage, to~     improve the lean mass, palmar prehension strength, muscular strength on the lower limbs and~     flexibility, also obtaining better biochemical profiles after the training period.~   "
40973|NCT03030417|"~     Background:~      The new drug LMP744 damages DNA. This causes cell death. Researchers want to see if it can~     treat certain kinds of cancer. They want to understand how the drug works and how it affects~     the body.~      Objective:~      To test the safety of LMP744 and find out the dose of the drug that can be safely given to~     humans.~      Eligibility:~      Adults at least 18 years old who have metastatic solid tumors or lymphoma, which have~     progressed after other treatment.~      Design:~      Participants will be screened with:~        -  Vital signs taken~        -  Blood and urine tests~        -  Heart tests~        -  Scans or ultrasound~      Some participants will have a tumor sample taken 2 times. A small piece of tumor is removed~     by a small needle. A scan or ultrasound will guide the process.~      The study will be done in 28-day cycles.~      Each cycle, participants will get the study drug in a vein for 60 minutes once a day for 5~     days.~      For day 1 of cycle 1, participants will be admitted to the clinic and have blood and urine~     taken several times.~      At the beginning of each cycle, participants will have a clinic visit and repeat some~     screening tests. They will also do this twice in the middle of cycle 1 and once in the middle~     of cycle 2.~      After participants stop taking the study drug, they will be followed for 30 days. They may~     give blood samples. They will be contacted by phone to see how they are doing.~   "
40974|NCT03030404|"~     Background:~      Gastric cancers are cancers of the stomach. Hereditary ones are passed from parent to child.~     Researchers want to gather data about hereditary gastric cancers. They want to learn about~     changes these cause in the body and about the genes involved.~      Objective:~      -To gather data about hereditary gastric cancer.~      Eligibility:~        -  People at least 2 years old with personal or family history with a hereditary gastric~          cancer.~        -  People at least 2 years old with gene changes that lead to such cancer or a lesion that~          may be hereditary.~      Design:~        -  Participants will be screened in a separate protocol.~        -  Participants will have:~             -  Physical exam~             -  Medical history~             -  Blood tests~             -  Scans~             -  Photos of skin lesions and other findings~             -  Gynecology consultation for women~             -  Cheek swab (some participants)~        -  For some participants, their relatives will be asked to join the study.~        -  Some participants will be asked to allow the study to get stored tissue samples for~          relatives who have died.~        -  Some samples will be sent to outside labs. All personal data will be protected. Samples~          will be destroyed when the study ends.~        -  Participants will get the results of genetic testing.~        -  Participants who cannot come to the NIH clinic may just give a cheek swab and have~          genetic testing done.~        -  Some participants will be contacted for more testing.~   "
40975|NCT03030391|"~     Background:~      The new drug 18F-PF-06445974 has a little radioactivity. This can be seen by a positron~     emission tomography (PET) scan. The drug helps researchers see a protein, PDE4B, in the~     brain. Looking at PDE4B in the living brain might show how it is involved in psychiatric and~     neurological disorders. One part of the study will look at how the study drug is distributed~     in the brain. Another part will study how brain measures vary.~      Objectives:~      To measure the protein PDE4B in the brain. To test how a new radioactive chemical,~     18F-PF-06445974, is distributed in the body.~      Eligibility:~      Healthy adults ages 18 and older~      Design:~      Participants will have 1-3 visits over a year. Each will be 2-5 hours.~      Women will have a pregnancy test each time.~   "
40976|NCT03030378|"~     This phase I trial studies the side effects and best dose of pembrolizumab and recombinant~     interleukin-12 in treating patients with solid tumors. Monoclonal antibodies, such as~     pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Recombinant~     interleukin-12 may kill tumor cells by blocking blood flow to the tumor and by stimulating~     white blood cells to kill tumor cells. Giving pembrolizumab and recombinant interleukin-12~     may work better in treating patients with solid tumors.~   "
40977|NCT03030365|"~     Despite the high prevalence of Alzheimer's disease (AD), its underlying mechanisms remain~     poorly understood. An emerging body of evidence supports disorientation as an early marker~     for AD-related neurodegeneration. In this study we intend to collect, coregister and analyze~     Positron Emission Tomography (PET) and , functional and structural magnetic resonance imaging~     (MRI, fMRI) data from AD-spectrum patients to establish orientation as core disturbance in~     AD.~   "
40978|NCT03030352|"~     The objectives of the How-to parenting program are 1) to improve optimal parenting style, and~     2) to foster children mental health (i.e. decrease in internalized and externalized problems,~     and well-being). The investigators expect that parents assigned to experimental groups will~     show improvements in parenting over time (i.e improvements in parental affiliation, parental~     structure and parental attitude toward autonomy), whereas parents in control groups will not~     show such improvements (i.e., stable or declining parenting quality). The investigators also~     expect children of parents in experimental groups to experience improvements in child mental~     health (i.e., fewer internalized and externalized psychological problems and increased~     well-being), whereas children whose parents are on the wait list will not show improvements~     over time (i.e., stable or deteriorating mental health and well-being).~   "
40979|NCT03030339|"~     The goal of this study is to assess whether children 12-18 months of age who are exposed to~     multiple large-scale vitamin A programs, and who are likely to have vitamin A intakes above~     the tolerable upper intake level (UL), have higher total body vitamin A stores and biomarkers~     of excessive vitamin A status, compared to children 12-18 months of age who have adequate~     vitamin A intake.~   "
40980|NCT03030326|"~     Twenty patients with a history of treatment, within the past year, of both asthma and either~     depression or an anxiety disorder will be recruited for this study. Patients will be~     recruited from their doctors and from advertisements. The investigators will randomly assign~     patients to two groups, using a crossover design. One group will first receive three months~     with four biweekly sessions of heart rate variability biofeedback treatment, and then will be~     followed for three months with a daily symptom diary. The other group will first be followed~     for three months, and then given the three months of treatment. In both treatment and~     following procedures, patients will receive psychophysiological testing sessions at the~     beginning and end of the three month period. The investigators will assess symptoms of~     asthma, anxiety, and depression as well as pulmonary function and will measure heart rate~     (from electrodes on the wrists), respiration (through a belt around the waist), end tidal~     carbon dioxide (through a cannula in the nose).~   "
40985|NCT03030261|"~     Based on the need to improve outcomes post second autologous stem cell transplant (ASCT) for~     multiple myeloma (MM) and the benefits seen of maintenance treatment following initial ASCT,~     the natural next step is to evaluate maintenance/continuation therapy following second ASCT.~      Pomalidomide is active against MM cells refractory to both bortezomib and lenalidomide,~     making it an ideal choice for continuation therapy following second ASCT. Adding elotuzumab~     may increase efficacy and also the durability of responses which is essential to improving~     outcomes following second ASCT.~   "
40986|NCT03030248|"~     There is good evidence that randomizing C. difficile NAAT(+), toxin(-) patients to~     non-treatment represents an ethically tolerable risk-benefit, even in cancer patients and~     hematopoetic stem cell transplant (HSCT) recipients. Actually, detection of free toxin in the~     stool was the standard of care for the diagnosis of C. difficile infection (CDI) from 1983~     through 2010. Since then, NAAT became the standard diagnostic test for over 60% of US~     hospitals (National Healthcare Safety Network, unpublished data). However, there is growing~     evidence that symptomatic patients who are NAAT(+), toxin(-) have outcomes similar to~     patients who are NAAT(-), toxin(-); some of these outcomes include 30-day mortality, ICU~     admission, and hospital readmission triggered by C. difficile. Furthermore, the United~     Kingdom has successfully used a similar two step diagnostic algorithm with a confirmatory~     toxin EIA since 2012.~      The adverse health consequences resulting from antibiotic overtreatment of NAAT(+), toxin(-)~     patients may be particularly important in transplant recipients. The usual treatment~     prescribed for CDI at the Froedtert Memorial Lutheran Hospital is oral vancomycin. While this~     drug has excellent activity against C. difficile and commonly suppresses its growth to~     non-detection, it does not eradicate carriage and its use results in marked and prolonged~     disruption of the lower intestinal microbiota. Meanwhile, the degree of lower intestinal~     microbiota disruption at the time of HSCT engraftment has been demonstrated to be an~     independent predictor (controlling for other markers of underlying disease) of overall and~     transplant-related 3-year mortality.14 In addition, recent findings suggest that bone marrow~     suppressive effects of antibiotics, in this case potentially unnecessary oral vancomycin~     (which is not appreciably absorbed), may be solely mediated via microbiota disruption. All~     these data supports the notion that antibiotic treatment of NAAT(+), toxin(-) C. difficile~     patients might have significant negative repercussions without a clear clinical benefit.~   "
40987|NCT03030235|"~     The primary purpose of this study is to evaluate the impact of dapagliflozin, as compared~     with placebo, on heart failure, disease specific biomarkers, symptoms, health status and~     quality of life in patients with type 2 diabetes or prediabetes and chronic heart failure~     with preserved systolic function.~   "
40988|NCT03030222|"~     The primary purpose of this trial is to evaluate the impact of empagliflozin, as compared~     with placebo, on hemodynamic parameters (pulmonary artery diastolic pressure) in patients~     with type 2 diabetes and heart failure (reduced or preserved ejection fraction, ischemic or~     non-ischemic etiology) who already have a CardioMEMs device implanted for non-study related~     clinical reasons.~   "
40989|NCT03030209|"~     Glucose homeostasis changes after distal pancreatectomy are not well understood. This study~     aim to identify the incidence of and risk factors for, a change in glucose homeostasis in~     patients who underwent distal pancreatic resection.~   "
40990|NCT03030196|"~     To determine the significance of systemic RANKL inhibition for male reproduction, conducting~     a clinical controlled randomized double blinded intervention study on infertile men, to~     investigating whether Denosumab (Prolia) can increase semen quality and to investigate what~     subgroup of infertile men that might benefit from treatment.~   "
40991|NCT03030183|"~     The purpose of the study is to evaluate the safety and efficacy of RA101495 in patients with~     Paroxysmal Nocturnal Hemoglobinuria (PNH) who have an inadequate response to eculizumab.~     Patients will be treated with RA101495 for 12 weeks.~   "
40992|NCT03030170|"~     Despite an improvement regarding morbidity and mortality since 30 years, especially in expert~     centers, pancreatic surgery remains currently associated to a significant postoperative~     morbidity reaching more than 60%. Regarding distal pancreatectomy (DP), the main complication~     following surgery is the occurrence of postoperative pancreatic fistula (PF) which may be~     able to lead an increased risk of bleeding, gastroparesis and finally a longer hospital~     stays. The main risk factors associated to the occurrence of pancreatic fistula are~     represented by the texture of the pancreatic parenchyma (soft pancreas) and the caliber of~     the main pancreatic duct (<3mm). Looking for new means of reducing the occurrence of~     pancreatic fistula is a priority in pancreatic surgery and a genuine public health issue.~     Currently, no formal recommendations concerning the optimal technical for closure of the~     distal stump in DP are available. In fact, manual closing by elective suturing or stapling of~     the main pancreatic duct give similar results. The use of a reinforcing stapling potentially~     represents a simple way to decrease the occurrence of pancreatic fistula and requires~     evaluation by a prospective randomized study.~   "
40993|NCT03030157|"~     Up to 30-40% of the patients may develop bladder recurrance after radical nephroureterectomy~     for primary upper tract urothelial carcinoma. Bladder tumor needs transurethral resection,~     which is associated with costs of treatment and potential poor prognosis. Although several~     randomized controlled trial have shown that prophylactic intravesical chemotherapy could~     prevent bladder tumor recurrence, the optimal schedule and duration of treatment are unkown.~     The investigators want to determine the efficiacy of single instillation versus long-term~     intravesical instillation of pirarubicin for bladder recurrence after radical~     nephrouretectomy for primary upper tract urothelial carcinoma.~   "
40994|NCT03030144|"~     The international literature emphasizes the vast benefits of the effective implementation of~     evidence based nursing recommendations in improving patient care processes and enhancing~     health outcomes. The key role of nurses in the prevention, treatment and care of incontinence~     is highlighted. Studies have shown that UI is a neglected nursing care problem in Austria~     e.g. regarding diagnosis and nursing interventions. Nursing recommendations may enhance the~     frequency of diagnosis, the use of nursing interventions as well as decrease the frequency of~     daily UI in nursing home residents. Beside that little is known about nursing recommendations~     implementation regarding urinary incontinence in the nursing home setting, especially in the~     Austrian context.~      The aim of this study is to measure the effectiveness of the implementation of evidence based~     nursing recommendations regarding UI in Austrian nursing homes.~   "
41085|NCT03028961|"~     The purpose of the proposed research study is to evaluate whether bone marrow transplant~     patients prefer the Stanford letter advance care planning tool to the standard Advance~     directive.~      Completion of advance care planning prior to BMT is very important, but not often done. The~     investigators believe that the Stanford Letter will be preferred by patients and will allow~     them to feel more comfortable and share more of their wishes with family members and the~     medical team.~   "
40995|NCT03030131|"~     Lung cancer is still the leading cause of cancer related-deaths worldwide, with an overall~     all-stage 5-year survival of approximately 17%. The primary treatment of early stage (I-IIIA)~     NSCLC is curative surgery. Although patients treated with curative surgery have a better~     prognosis, the 5-year survival for patients treated with surgery alone remains low, ranging~     from 67% (stage IA) to 23% (stage IIIA). Several randomized trials comparing postoperative~     chemotherapy versus no chemotherapy have shown a significant overall survival benefit from~     postoperative chemotherapy in completely resected patients with NSCLC stage II and IIIA.~     Likewise other randomized trials have demonstrated preoperative chemotherapy improves~     survival and recently the analyses also based on individual patients data of 15 randomized~     trials showed a significant benefit of preoperative chemotherapy on survival with the same~     survival improvement of 5% at 5 years. Then, neoadjuvant chemotherapy has also become~     accepted in many countries.~      Targeting of PD-1 receptors and its ligand PD-L1, and inhibiting their engagement is an~     attractive therapeutic option in the early stage NSCLC, which may reactivate host immune~     responses and enable longterm tumor control.~   "
40996|NCT03030118|"~     This project is a multicenter, randomized, placebo-controlled, double-blind clinical trial~     that is designed to test whether treating patients who are at risk for development of lupus~     with hydroxychloroquine can slow accumulation of disease features. Effects on clinical~     progression of symptoms, patient-reported outcomes and changes in the immune markers of~     response will be measured and toxicity of the treatment will be assessed. This trial is a~     first step in testing a prevention strategy for lupus.~   "
40997|NCT03030105|"~     This is a Phase 1, randomized, double-blind, placebo-controlled, 6-period crossover study to~     evaluate the effects of BPN14770 10 mg and 50 mg in reversing scopolamine-induced cognitive~     impairment in healthy volunteers. A positive control, donepezil 10 mg, will be included, and~     additivity of BPN14770 50 mg to donepezil 10 mg in reversing scopolamine effects will also be~     evaluated.~   "
40998|NCT03030092|"~     One group will receive today's standard rehabilitation program following hip fracture~     surgery. The intervention group will have maximal strength training incorporated in their~     program. It consists of 3 training sessions per week for 8 weeks, where 4-5 repetitions over~     4 sets for leg press and abduction resistance exercise at 85% of maximal strength is carried~     out. Oxygen consumption of walking, muscle mass, strength, balance and bone density will be~     compared between the groups following the 8-week rehabilitation period.~   "
40999|NCT03030079|"~     The goal of this pilot study is to assess the effectiveness of an electrical stimulation~     therapy option for the treatment of chronic phantom limb pain in upper or lower limb~     amputees. This therapy has been previously used for sports and joint injuries and is marketed~     for relaxation of muscle spasms, re-education of muscle action, prevention of disuse atrophy,~     increased local blood circulation, and maintaining or increasing range of motion. The~     investigators would like to explore the idea that physically exercising the muscles of the~     residual limb and increasing blood flow to the site of amputation through the promotion of~     motor contraction using electrical stimulation decreases chronic phantom limb pain.~   "
41000|NCT03030066|"~     This is a study to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics~     (PD) and anti-tumor activity of DS-1001b in patients with gliomas that harbor IDH1-R132~     mutations.~   "
41001|NCT03030053|"~     A double-blind, randomised, controlled, parallel arm chronic intervention trial with healthy~     older adults will be conducted to determine the effect of a flavonoid-rich supplement on~     cognitive function, peripheral arterial health and brain mechanisms. It is predicted that~     chronic flavonoid supplementation will result in cognitive benefits and that these may be due~     to beneficial effects of flavonoids on vascular and brain function.~   "
41002|NCT03030040|"~     This study examines whether a mindfulness-based self-help book is effective at reducing~     healthcare workers' levels of stress and improving their wellbeing.~   "
41003|NCT03030027|"~     The purpose of the present study is to examine the effects of perspective-taking reappraisals~     on the well-being of adult-child dementia caregivers.~   "
41004|NCT03030014|"~     assess the effect of dental educational program on oral hygiene among institutionalized~     hearing impaired and mute children in Cairo, Egypt.~   "
41005|NCT03030001|"~     This is a single-arm, open-label, one center, dose escalation clinical study, to determine~     the safety and efficacy of infusion of autologous T cells engineered to express immune~     checkpoint antibody and chimeric antigen receptor targeting mesothelin in adult patients with~     mesothelin positive, recurrent or refractory malignant tumors.~   "
41006|NCT03029988|"~     Estimation of the concordance of Tc 99m localization in liver metastases from colorectal~     carcinoma using SPECT/CT imaging and abdominal FDG (PET)/CT imaging per subject.~   "
41007|NCT03029975|"~     Humans lose muscle and strength as they get older. Further, ageing is accompanied by loss in~     cognitive function. It is not quite clear why this happens; however, it is known that the~     loss of muscle and strength can increase risk for physical and mental health risks and impair~     the ability of older people to remain physically independent. Weight lifting and proper~     nutrition, particularly eating high quality protein at the proper time and quantity, may help~     prevent these losses when a person gets older. To determine if regular beef consumption as~     part of a higher protein diet aids the muscle adaptive response to resistance training and~     improvements in cognition, seventy healthy individuals will be recruited to lift weights 3~     times a week for 10 weeks. One group (n=36) will consume the Recommended Dietary Allowance~     (RDA) for protein (0.8g/kg/day), while the other group (n=36) will consume an amount twice~     the RDA (1.6g/kg/day), which is in agreement with recommendations from the American College~     of Sports Medicine. Participants will have their muscle strength tested and samples of blood~     and muscles will be collected before and after training to determine how the muscle adaptive~     response to resistance exercise is affected by higher protein intake. In addition,~     participants will undergo cognitive assessments at baseline and follow-up to determine the~     influence of improving muscle strength on attention and memory. Overall, the investigators~     proposed study will use sensitive methodology to determine if providing protein above the RDA~     and at optimal times during the day in combination with a weight lifting program can help~     make someone stronger and build larger muscles than someone consuming the RDA, as well as~     what processes may be responsible for helping the muscles to get bigger and stronger.~   "
41010|NCT03029936|"~     Obesity and asthma share changes that may begin in the fetal development phase. The~     endophenotype obesity-asthma presents as main characteristic a pattern of inflammatory~     response different from the habitual Th2 profile of cytokines. In these obese patients,~     possible changes in the diaphragm muscle can directly influence the dynamics of pulmonary~     ventilation significantly.~      Due to the importance of the diaphragm in pulmonary ventilation, this study will be performed~     to verify possible alteration in the excursion and diaphragmatic thickness of adolescents~     with endophenotype obesity-asthma. In parallel, the possible underlying etiopathogenic~     substrate of this endophenotype will be explored through the dosing of muscle enzymes and~     inflammatory cytokines and obesity hormones.~   "
41011|NCT03029923|"~     Quitting smoking following acute coronary syndrome can reduce mortality up to 50%. However,~     depression and smoking are highly co-morbid and depressed mood may interfere with cessation~     and independently predicts mortality. Thus, a single, integrated treatment for both smoking~     and depression could be highly effective in reducing post-acute coronary syndrome mortality.~     Behavioral Activation (BA) is a well established treatment for depression and has recently~     shown promise as a treatment for smoking cessation. The investigators systematically~     developed an intervention integrating gold standard smoking cessation counseling with~     existing BA based mood management techniques for post-ACS smokers; Behavioral Activation~     Treatment for Cardiac Smokers (BAT-CS).~      Objective: For this R56 the investigators will conduct a vanguard trial to pilot all methods,~     materials, and systems for the later fully powered BAT-CS vs. attention control trial. The~     investigators will enroll up to 36 smokers with ACS and randomize them to 12 weeks of BAT-CS~     or an attention control (Health and Wellness Education). Both groups will be offered the~     nicotine patch if medically safe.~   "
41012|NCT03029910|"~     The purpose of this study is to determine the effectiveness of eccentric exercise combined~     with vibration or cryotherapy in Achilles tendon pathology.~      The investigators hypothesis is that the combined eccentric exercise is better than the~     results presented by the exclusive eccentric exercise.~      This intervention differs from the classic studies in that we maintain the intensity~     throughout the treatment.~   "
41013|NCT03029897|"~     Adverse drug reactions are collected exhaustively during the experimental development phase~     of the drug, but the trial population is not representative. In post-marketing authorization,~     the use in the real life of medicines requires to specify the profile of adverse effects~     through pharmacovigilance. However, in clinical practice, under-reporting of adverse drug~     reactions prevents a satisfactory knowledge of the risks. For example, in the multiple~     sclerosis (MS) patients population in 2015, only 1 case of congestive flushing was reported~     by physicians, none by patients, for approximately 7,800 patients treated with Tecfidera®~     dimethyl-fumarate, while trials reported 39% of flush.~      The investigators propose a study measuring the impact of the deployment of e-reporting to~     patients in a population suffering from multiple sclerosis in initiation of first line drug~     therapy. The study design will be a randomized controlled trial. Twenty-four direct or~     indirect partner centers of the OFSEP will be randomized in 2 arms (1 standard arm without~     intervention, and one interventional arm), Each arm including 6 CHU, 3 CHG and 3 liberal~     neurologists. CHUs will include 10 patients in 6 months, and CHGs and liberal neurologists 5~     patients, a total of 180 patients will be included. The expected duration of this study is 12~     months, 6 months of inclusion of patients, and one 6-month follow-up period for each patient.~     At 1 month (+/- 15 days) of the follow-up period of each patient, a questionnaire will be~     made by telephone call to each patient.~      The study is part of the pharmacovigilance system in place in France and aims to improve its~     efficiency by increasing declarations and therefore earlier detection of signals in order to~     prevent and minimize risks.~      The comparison of the two arms should make it possible to decide on the usefulness of~     national support for e-reporting, while respecting a good integration with the French~     pharmacovigilance system.~   "
41014|NCT03029884|"~     This study evaluates invasive deep brain stimulation (DBS) in the treatment of three types of~     chronic neuropathic pain, i) Post Stroke pain syndrome ii) Phantom Limb pain and iii) Spinal~     Cord Injury Pain. Participants will be implanted with recording / stimulation electrodes in~     pain-related circuits of the brain. Relief of pain symptoms with stimulation will be studied~     in both groups. It is hypothesized that neural signals will correlate with pain states and~     that DBS can disrupt these pain states in both groups, perhaps with differences in underlying~     neural mechanisms for pain relief.~   "
41015|NCT03029871|"~     The primary objective of this phase 1 trial is to determine the dose-dependent toxicity and~     maximum tolerated dose (MTD) of oncolytic adenovirus-mediated cytotoxic gene therapy in~     combination with SBRT in medically inoperable stage I/IIA (T1A - T2B) NSCLC. To accomplish~     this objective, 9 subjects will be enrolled in the study. We hypothesize that the combined~     treatment will demonstrate acceptable toxicity, and that it will be feasible to quantify~     adenovirus-mediated HSV-1 TK gene expression in the lung by PET. This phase 1 trial will lay~     the foundation for a follow-up phase 2 trial designed to examine efficacy.~   "
41016|NCT03029858|"~     The study will investigate whether PD-L1 and other immuno-markers will be influenced by~     osimertinib treatment in advanced epidermal growth factor receptor （EGFR）T790M positive~     advanced NSCLC patients. In addition, we will explore whether PD-L1 and other immuno-markers~     can predict the safety and efficacy of subsequent use of immune checkpoint inhibitors at the~     time of PD due to osimertinib resistance.~   "
41017|NCT03029845|"~     The purpose of the study to evaluate the feasibility of using low dose propranolol for people~     with fibromyalgia.~   "
41018|NCT03029832|"~     This is a Phase II, multicenter, randomized, placebo-controlled, double-blind study to~     evaluate the safety and efficacy of MOXR0916 in combination with atezolizumab versus placebo~     and atezolizumab in participants with locally advanced or metastatic urothelial carcinoma~     (UC) who have not received prior systemic therapy in the locally advanced/metastatic setting~     and who are ineligible to receive cisplatin-based therapy.~   "
41019|NCT03029819|"~     The purpose of this study is to investigate text messaging as a way to enhance~     mindfulness-based treatment for smoking cessation.~   "
41020|NCT03029806|"~     The purpose of this study is to investigate the role dietary salt plays in epigenetic~     regulation of blood pressure, focusing on the salt-sensitive regulatory enzyme~     Lysine-specific demethylase 1.~   "
41021|NCT03029793|"~     The purpose of this study is to determine whether combination of molecular and biomarkers~     with functional imaging can predict pathologic response and clinical outcomes in squamous~     esophageal cancer patients who undergo trimodality therapy which includes neoadjuvant~     chemoradiotherapy and surgery~   "
41022|NCT03029780|"~     The purpose of this study is to evaluate safety and efficacy of different administration~     regimens of nivolumab plus ipilimumab in subjects with renal cell carcinoma.~   "
41023|NCT03029767|"~     Hypertension is the most common risk factor for development of stroke, congestive heart~     failure chronic kidney disease, and coronary artery disease in Sub Saharan Africa. The~     prevalence of hypertension will increase by 2025 in most parts of the world including~     Ethiopia according to World Health Organization.~      Physical inactivity has been identified as a stronger predictor of chronic diseases such as~     hypertension. Exercise as a lifestyle modification is beneficial to a wide variety of health~     conditions, specific to hypertension; the benefits of exercise have been promoted by a number~     of organizations and agencies including World Health Organization.~      According to the knowledge of the investigator there are no research works in relation to~     aerobic and resistance exercise effects among hypertensive patients generally in Ethiopia,~     and particularly in the area selected for the present research. Therefore the aim of this~     study is to assess the effect of aerobic and resistance exercises on selected anthropometric,~     biochemical and physiological variables among hypertensive patients in Hawassa University~     Referral Hospital.~   "
41024|NCT03029754|"~     The investigators wish to determine whether passive leg raise allows for easier peripheral~     vascular access in the pediatric population. The investigators hypothesize that pediatric~     anesthesiologists will have higher rates of successful intravenous catheterization in~     children where a passive leg raise is employed.~   "
41025|NCT03029741|"~     The Sponsor is developing the study drug, AZD0284, for the potential treatment of Plaque~     psoriasis. Psoriasis is a skin condition that causes red, flaky, crusty patches of skin~     covered with silvery scales. It occurs when skin cells are replaced more quickly than usual.~     The seriousness of psoriasis varies greatly from person to person. For some people it is a~     minor irritation, but for others it can have a major impact on their quality of life. .~      The purpose of the study is to determine how much of AZD0284 is taken up by the body. The~     safety and tolerability of the drug will also be assessed. It is hoped that the study drug~     will improve the management of psoriasis.~   "
41026|NCT03029728|"~     Development of a new mass spectrometry based biomarker for the early and sensitive diagnosis~     of hereditary angioedema disease type 1 from plasma~   "
41027|NCT03029715|"~     Background: Laparoscopic sleeve gastrectomy is commonly done with total intravenous~     anaesthesia (TIVA) or balanced anaesthesia using intravenous and an inhalation agent. It is~     still unclear which anaesthesia regimen is better for this group of patients. The present~     study was carried out to compare the use of inhalation anaesthesia technique using desflurane~     and TIVA using propofol and dexmedetomidine.~      Methods: This randomized controlled trial was carried out on 100 morbidly obese patients~     undergoing laparoscopic sleeve gastrectomy. The patients were randomized into two equal~     groups, inhalational group and TIVA group for anaesthesia maintenance. All patients received~     general anaesthesia and induced with propofol, remifentanil and cis-atracurium. In inhalation~     group, anaesthesia was maintained by desflurane in oxygen air mixture while in TIVA group~     anaesthesia was maintained by intravenous propofol and dexmedetomidine infusion.~     Intra-operative vital signs and anaesthesia recovery time were recorded. Post-operative~     nausea, vomiting, pain score, analgesic consumption, the onset of bowel movement, and~     post-anaesthetic care unit (PACU) stay were studied for both groups.~   "
41028|NCT03029702|"~     Gestational diabetes (GDM) is a significant clinical and public health burden, affecting over~     400,000 pregnant women in the United States each year. Without adequate treatment, women with~     GDM and their infants are at risk for substantial morbidity. Because of this, experts~     recommend treatment focused on normalization of hyperglycemia to improve outcomes. However,~     providers have limited capacity to predict which treatment will achieve glycemic goals. This~     results in a choice based on provider and patient preference and a trial and error approach,~     which can create delays in glycemic control within the short (8-10 weeks) window between~     diagnosis and delivery. Maternal and fetal morbidity may be related to a mismatch between~     glycemic pathophysiology and the mechanism of action of glucose-lowering agents. In fact, GDM~     is heterogeneous, with predominant insulin resistance (IR) in 50%, insulin secretion deficit~     (ISD) in 30%, and a combination of both in 20% of women as underlying mechanisms of~     hyperglycemia. This variation in GDM pathophysiology and clinical outcomes supports the use~     of an individualized treatment approach. The overall goal of this project is to investigate~     an individualized treatment approach for GDM where treatment is based on each woman's GDM~     mechanism. The study will employ the same treatment in both arms, but choice of treatment~     will differ based on study arm (matched or unmatched to GDM mechanism).~   "
41029|NCT03029689|"~     The project presented here will be the first prospective, randomized evaluation of the effect~     of ART on the structure and function of the gut microbiome. This study provides a unique~     opportunity to understand the benefits of ART with high intestinal penetration on the gut~     microbiome. It is thus a key study to understand the bidirectional interactions between the~     microbiome and the host in people living with HIV/AIDS.~   "
41030|NCT03029676|"~     This study evaluates the influence of premedication on cognitive functions in patients~     undergoing transurethral resection of bladder tumor under spinal anesthesia. The aims of~     premedication are anxiolysis, analgesia and the reduction of perioperative risk among the~     patients with comorbidities. The patients will be randomly allocated to receive premedication~     either with opioid solely or with benzodiazepine combined with opioid. The anesthetic~     technique is standardized.~   "
41031|NCT03029663|"~     This is a prospective study enrolling consecutive patients who undergo transurethral~     resection of the bladder tumour (TURBT) aimed at determination of a safety of the procedure.~     Study end-points are incidence, severity and predictive factors of surgical complications.~     The study secondary aim is a validation of Clavien Dindo scoring system for reporting~     complication of TURBT.~   "
41032|NCT03029650|"~     The study to be performed will utilize already FDA-approved marketed products in healthy~     adults for the purpose to generate data for establishing rate of drug delivery of Transderm~     Scop® TDDS (transdermal drug delivery system) in healthy adults and to ensure safety of~     individuals utilizing these types of products.~   "
41086|NCT03028948|"~     This clinical trial studies how well an interactive tailored website works in promoting sun~     protection and skin self-check behaviors in patients with stage 0-III melanoma. An~     internet-based program may help individuals to perform skin self-checks and engage in sun~     protection behaviors.~   "
41033|NCT03029637|"~     Tooth replacement is a significant issue in the World. Such replacement is considered~     important by patients to improve aesthetics, function and quality of life. Tooth replacement~     is therefore a significant issue. Resin-bonded bridges (RBBs) are conservative and~     cost-effective tooth replacement option that involves minimal tooth preparation and are~     secured in place with an adhesive cement by bonding to the outer enamel layer of the tooth.~     Clinical reports of these prostheses at the University of Hong Kong shows some of the highest~     success rate and greatest longevity in the dental literature. However, a problem with this~     type of prosthesis in that it still needs some tooth preparation to accommodate the framework~     thickness of the bridge. In some patients with tooth wear, this may mean cutting through the~     enamel crown down into dentine which will weaken the tooth. In light of the tooth preparation~     some patients will refuse this treatment, in particular patients with dental drill phobias.~      The aim of this study is to investigate RBBs with tooth preparation and with no tooth~     preparation for the replacement of single missing teeth in a randomized controlled trial.~     However, a significant consequence of a no preparation RBB will mean that after cementation~     the prosthesis will interfere with the patient's bite, making the bridge prosthesis stand~     high. This will take time for the patient's original occlusion to re-establish itself by the~     movement of the tooth supporting the bridge. Despite the success of supra-occluding~     restoration has been reported in some studies, currently neither no preparation nor~     supraoccluding dental bridges are the standard of care for general dental practitioners and~     have not been reported on as a clinical trial in the literature. Most symptoms reported for~     supraoccluding restorations were transient and are reversible. The findings of this research~     will have significant impact on the teaching and practice for clinical prosthodontics and~     patient care worldwide. Patients will have a dental prosthesis that requires no dental~     drilling, no local anaesthetic and will have a stronger tooth supporting the bridge that~     should have greater longevity. More patients, in particular phobic patients will therefore~     seek treatment for tooth replacement with this conservative treatment option.~   "
41034|NCT03029624|"~     The study is a single arm, prospective study of the safety and effectiveness of the Valencia~     Technologies eCoin System to stimulate the tibial nerve for the treatment of patients with~     refractory urgency urinary incontinence.~   "
41035|NCT03029611|"~     This phase II trial studies how well pUMVC3-IGFBP2 plasmid deoxyribonucleic acid (DNA)~     vaccine (IGFBP-2 vaccine) and combination chemotherapy work in treating patients with stage~     III-IV ovarian, fallopian tube, or primary peritoneal cancer undergoing surgery. IGFBP-2 is a~     protein found in the blood and tumor cells of most who have been diagnosed with ovarian~     cancer. Too much IGFBP-2 has been associated with more invasive disease. Vaccines made from~     DNA may help the body build an effective immune response to kill tumor cells that express~     IGFBP-2. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Giving IGFBP-2 vaccine and combination~     chemotherapy may work better in treating patients with stage III-IV ovarian, fallopian tube,~     or primary peritoneal cancer undergoing surgery.~   "
41036|NCT03029598|"~     This phase I/II trial studies how well pembrolizumab and carboplatin work in treating~     patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back or has~     not responded to previous treatment. Monoclonal antibodies, such as pembrolizumab, may~     interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy,~     such as carboplatin, work in different ways to stop the growth of tumor cells, either by~     killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving~     pembrolizumab and carboplatin may work better in treating patients with ovarian, fallopian~     tube, or primary peritoneal cancer.~   "
41037|NCT03029585|"~     This study will evaluate NanoPac® administered intraperitoneally (IP) immediately~     post-cytoreductive surgery, followed by standard of care (SOC) intravenous (IV) chemotherapy,~     in women with ovarian cancer. The study will compare IP NanoPac® (plus IV chemotherapy) with~     SOC IV chemotherapy alone.~   "
41038|NCT03029572|"~     An intervention study design in 90 obese patients will be used. Nutritional, metabolic and~     psychological status as well as gut microbiota will be evaluated before gastric bypass and 6~     months post surgery. During this period of 6 months, all patients will receive a specific~     diet according to recommendation with regard to bariatric surgery.~      Subjects will be than randomized in 2 sub-groups:~      A. patients receiving a standard healthy diet without micro-nutriments' supplementation; B.~     patients receiving a healthy diet and probiotics, minerals, aminoacids, omega-3 acids vitamin~     and mineral supplementation~   "
41039|NCT03029559|"~     Rehabilitation approaches introduce a stimulus to a motor system, with the goal to enhance~     motor function to patients. For example, exposure to brief and intermittent episodes of mild~     hypoxia has shown to strengthen synaptic pathways to respiratory and skeletal muscle motor~     neurons. In humans with spinal cord injury, exposure to intermittent hypoxia (IH) alone or in~     combination with rehabilitative strategies has shown enhanced motor function. Another~     strategy known as inspiratory threshold loading, which involves breathing against pressure~     threshold loads, results in improved inspiratory muscle strength. Although there is evidence~     supporting the use of IH alone or in combination with other rehabilitative strategies in~     improving motor function in humans, the impact of exposure to IH or IH with inspiratory~     threshold loading on inspiratory muscle function and ventilation in humans is unknown.~   "
41040|NCT03029546|"~     The investigator's main objective is to analyze the effects of a routine prenatal care~     screening tool (glucola test for gestational diabetes) on maternal inflammation through~     assessment of maternal circulatory biomarkers and blood pressure. Improving knowledge about~     routine prenatal care and how a variety of screening factors affect maternal physiology~     allows the investigators to be educated and informed when caring for mothers with medical~     co-morbidities.~        -  Determine if an acute glucose load (50g) is associated with an in-vivo and in-vitro~          increase in the concentration of Advanced Glycation End Products (AGEP's) that, in turn,~          can impact vascular endothelial reactivity and induce an acute increase in blood~          pressure. Previous studies generated in the investigators' laboratory showed that~          circulating soluble Receptor for Advanced Glycation End Products (sRAGE) and Tumor~          Necrosis Factor (TNF)-a (mediator of acute inflammation) are considered markers of the~          extent of maternal RAGE activation and/or systemic inflammation, respectively.~        -  Determine how an acute glucose load (50g) at the time of normal screening for~          gestational diabetes induces an acute increase in the level of sRAGE and TNF-a. If the~          investigators' hypothesis is confirmed, the investigators will have strong confirmation~          of the involvement of glycation products and TNF-a in generating the acute negative~          clinical symptoms of women experiencing a glucose tolerance test, such as headache,~          nausea, sweating, and bloating.~   "
41041|NCT03029533|"~     The purpose of this study is to evaluate the pharmacokinetic characteristics and safety of~     DWJ108J (leuprolide acetate) and Leuplin DPS Inj administered subcutaneously in patients with~     prostate cancer~   "
41126|NCT03028428|"~     In this study, researchers want to determine the safety of MSCs that a patient can tolerate~     without causing side effects. Moreover researchers will also be looking at the function of~     the knee over time, which may give them some insight on the usefulness of MSCs as a treatment~     option.~   "
41042|NCT03029520|"~     The aim of this study was to evaluate and compare postoperative pain and overextension of~     root canal filling after root canal treatment using a carrier-based obturation system and two~     different sealers.~      In this prospective randomized clinical trial, 160 mandibular premolars and molars in 160~     patients were treated. Patients with vital and devital teeth were assigned to four groups~     using a randomized block design with block sizes of 10 patients each. The groups were~     composed of devital teeth with periapical lesions treated with iRoot SP sealer, vital teeth~     treated with iRoot SP sealer, devital teeth with periapical lesions treated with AH Plus~     sealer, and vital teeth treated with AH Plus sealer. In single visits, a single operator~     prepared root canals and filled them with sealer using the carrier-based obturation~     technique. Radiographs were taken and obturation length was recorded. Patients recorded pain~     scores use of Visual Analogue Scale and frequency of analgesic intake at baseline and 0-6,~     6-12, 12-24, and 24-72 h..~   "
41043|NCT03029507|"~     The proposed study is a cohort-randomized controlled trial of Acceptance and Commitment~     Therapy-enhanced ShipShape (ACT+SS) compared to the standard ShipShape-only program, for~     overweight or obese Navy personnel.~   "
41044|NCT03029494|"~     The objective of this study is to quantify salivary oxidative stress biomarkers in patients~     with temporomandibular disorders and to quantify recently isolated endogenous peptide~     opiorphin in saliva of these patients. As chronic exposure to stress may cause hyperalgesia~     as a result of the stress response in the hypothalamic-pituitary-adrenal axis, aim is to test~     this as an underlying mechanism by correlating opiorphin and oxidative stress markers to~     salivary cortisol levels. The aim is to assess the association of oxidative stress salivary~     biomarkers with muscle and joint pain and to measure opiorphin, a potential biomarker of~     different pathological states.~   "
41045|NCT03029481|"~     Despite improvements in outcomes for patients with localized Ewing sarcoma, patients with~     relapsed metastatic Ewing sarcoma continue to have poor outcomes with current chemotherapy~     options. A large body of preclinical data supports a role for IGF-1R inhibition in the~     treatment of Ewing sarcoma.~      More recently, clinical trials of IGF-1R monoclonal antibodies have demonstrated single-~     agent activity in patients with relapsed Ewing sarcoma. Ganitumab (AMG 479) is a fully human~     monoclonal antibody directed against IGF-1R. We are proposing this single-agent expanded~     access IND to provide our patient the opportunity to benefit from this treatment after having~     developed progressive disease after multiple lines of prior therapy.~   "
41046|NCT03029468|"~     The primary aim of this study is to test the feasibility and acceptability of implementing a~     multimedia computerized cognitive behavioral therapy (cCBT) program for reducing SCD pain~     symptoms in a single-arm pilot pragmatic clinical trial. The investigators will recruit 40~     SCD patients with chronic pain and/or on chronic opioid pain treatment and randomize them 3:1~     to two groups (cCBT and e-Education respectively), randomizing unevenly in order to best~     gather feasibility data for the cCBT. Both groups will use a mobile app to track daily~     pain/mood. The cCBT group will receive sessions of the CALM-SCD program to complete via~     mobile device and will have weekly follow-up with a care coach. The Education group will~     receive online education modules to complete via mobile device and will also have weekly~     follow-up with a care coach. The primary outcomes of the trial include feasibility~     (recruitment, retention, provider and patient feedback) and acceptability (sessions~     completed) of the CALM-SCD program.~   "
41047|NCT03029455|"~     Evaluate the safety and tolerability of VX-659 in healthy subjects~   "
41048|NCT03029442|"~     The purpose of this study is to determine the usefulness of a drug, denosumab, to prevent the~     loss of bone in participants legs due to SCI. This drug is FDA approved to treat osteoporosis~     in women after menopause who have an increased risk for fractures, to treat women receiving~     certain treatments for breast cancer who have an increased risk of fractures, and to treat~     bone loss in men receiving certain treatments for prostate cancer who have increased risk for~     fractures. This drug is considered experimental for the purpose of this study. Study~     participation will last for approximately 12 months (6 study visits total), visits will range~     from1-4.5 hours depending on the number of tests that need to be completed. The study is a~     double-blinded placebo trail in which the participant will be randomly assigned to on of two~     groups, Denosumab injections or placebo - inactive salt solution injections.~   "
41049|NCT03029429|"~     Pseudohypoparathyroidism is a genetic disorder with limited treatment options. Patients have~     early-onset obesity, short stature and increased risk of type 2 diabetes. This phase 2~     clinical trial will test the efficacy of theophylline, a phosphodiesterase inhibitor, in~     pseudohypoparathyroidism. The investigators hypothesize that theophylline will cause weight~     loss, improve glucose tolerance and slow growth plate closure in children and young adults.~   "
41050|NCT03029416|"~     30 Gy single fraction of SBRT for lung metastases will result in comparable oncologic~     outcomes to 18Gy in three fractions (or dosing to a BED </-100Gy at the discretion of the~     radiation oncologist) with respect to disease control and toxicity.~   "
41051|NCT03029403|"~     This is a phase 2 study whose purpose is to see whether the combination of of pembrolizumab,~     DPX-Survivac vaccine and low-dose cyclophosphamide has anti-tumor activity in patients with~     advanced epithelial ovarian, fallopian tube or primary peritoneal cancer.~      DPX-Survivac is an investigational vaccine. A vaccine is a substance that is often given to~     stimulate the body's immune system (the structure and processes in the body that protects~     against harmful substances) to help prevent against certain diseases. DPX-Survivac is a~     vaccine that may teach the immune system to recognize cancer cells and to kill them.~      Pembrolizumab is a drug that is approved for the treatment of a certain type of melanoma (a~     type of skin cancer) and non-small cell lung cancer. Pembrolizumab blocks the function of a~     protein called programmed cell death receptor-1 (PD-1). PD-1 works by keeping the immune~     system from destroying cancer cells. Stopping PD-1 from working may help the immune system to~     fight cancer cells.~      Cyclophosphamide is chemotherapy drug that is approved for the treatment of various cancers~     alone and in combination with other drugs.~   "
41087|NCT03028935|"~     This pilot clinical trial studies how well an evidence-based exercise and nutrition program~     adapted for Latinas works in improving physical activity and dietary behavior in non-active,~     overweight, or obese rural Latinas. An exercise and nutrition program may reduce the risk for~     developing certain cancers, obesity, and chronic health conditions in Latinas who are~     non-active, overweight, or obese.~   "
41052|NCT03029390|"~     Pre diabetes (PD) is a term that refers to alterations in glucose homeostasis, including~     impaired fasting glucose (IFG), Imparied glucose tolerance (IGT) or both, involving a higher~     risk to develop type 2 diabetes mellitus (T2DM) in 10 years.~      The efficacy of pharmacotherapy in the prevention of diabetes in adults with prediabetes has~     been demonstrated, the first line of pharmacology treatment is metformin, on the other hand,~     the traditional Chinese and Ayurverica medicine offer potential active substances for the~     treatment of hyperglucemia like berberine.~      Berberine is an extract with hypoglycemic effects in animal models as well as in clinical~     trials in type 2 diabetes mellitus even compared to metformin, for this reason comparing it's~     activity against metformin in prediabetes would provide impact information on a new~     alternative treatment and compare with the standard pharmacological treatment.~      The aim of the study evaluate the effect of administration of berberine versus metaformine on~     glycemic control, insulin secretion and insulin sensitivity in patients with pre diabetes.~      The investigators hypothesis is that the administration of berberine versus metformin~     modifies glycemic control, insulin sensitivity and insulin secretion in patients with~     prediabetes.~   "
41053|NCT03029377|"~     The objective of this study is to measure sympathetic nervous system function and stress~     responses in patients with clinically documented and self-reported chronic fatigue that is~     worsened by stress, compared to healthy controls. Baseline norepinephrine (NE) levels and~     stress-induced NE levels in patients who fulfill criteria for Chronic Fatigue Syndrome (CFS)~     and who self-identify with stress induced worsening fatigue, will be compared to data from~     normal individuals pre and post-stress.~   "
41054|NCT03029364|"~     The ability to upregulate fat oxidation at appropriate times such as during fasting, low to~     moderate intensity exercise and after a high fat meal, is popularly advocated. This is~     presumably due to the perception that a high capacity to utilise fat may improve (ultra)~     endurance performance and help in the regulation of body fat and metabolic diseases. In~     accordance, impaired fat use at rest has been associated with obesity and insulin resistance~     (Kelley et al., 1999). However, there is inconclusive and / or a lack of systematic evidence,~     especially in a large diverse range of adults, exploring:~        1. Whether whole body fat use during exercise is altered in individuals with overweight or~          obesity compared to lean individuals~        2. Whether whole body fat use at rest and during exercise is associated with prospective~          changes in body composition~        3. The intra-individual variability in whole-body fat use at rest and during exercise~        4. Physiological, metabolic, lifestyle and genetic characteristics that are associated with~          whole-body fat use at rest and during exercise~      Therefore, the objectives of this study are three-fold:~        1. To explore whether whole body fat use is associated with body composition and~          prospective changes in body composition~        2. To explore associations between whole-body fat use and physiological, metabolic,~          lifestyle and genetic variables~        3. To assess the intra-individual variability of whole-body fat use.~      This study is an observational, exploratory cross-sectional and prospective study. A wide~     range of 'healthy' and 'at-risk of metabolic disease' adults will be recruited.~      Participants will be asked to visit a laboratory at the University of Bath three times. Visit~     1 is a screening and study familiarisation visit. Visits 2 and 3 are to be completed within~     7-14 days and involve lifestyle monitoring (dietary and physical activity), a one-off urine~     and blood sample, assessment of fuel use at rest and during exercise (the latter through an~     incremental graded cycling exercise test to exhaustion). Body composition will be analysed~     via a dual-energy x-ray absorptiometry (DEXA) scan in addition to an optional skeletal muscle~     and / or fat tissue biopsy at either visit 2 or visit 3. Participants will also be offered an~     optional approx. 6-month follow-up session (Visit 4) that will involve body composition~     analysis via a DEXA scan.~   "
41055|NCT03029351|"~     This is a prospective study to evaluate effect of Exenatide extended release treatment for 1~     year on albuminuria levels in T2DM patients with micro- and macroalbuminuria compared to~     placebo.~   "
41056|NCT03029338|"~     In this single-center, open-label, no control, prospective clinical trial, a total of 10~     relapsed or refractory CD19 positive B-cell Non-Hodgkin Lymphoma (NHL) patients will be~     enrolled.CD19 CAR T cells(total dose of 2×10^6/kg-1×10^7/kg) will be intravenously infused to~     patient in a three-day split-dose regimen: 10% on day 0, 30% on day 1 and 60% on day 2. The~     purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells~     in patients with relapsed or refractory CD19 positive B-cell lymphoma.~   "
41057|NCT03029325|"~     Investigators use a genome-wide approach within a case-control design to identify SNPs that~     show evidence of association with lung cancer risk and survival.~   "
41058|NCT03029312|"~     Children with osteogenesis imperfecta (OI) have impaired bone strength, fractures, weak~     muscles and limited mobility. Mild to moderate forms of OI (type 1 and 4) may benefit from~     muscle training that leads to secondary improvement in bone strength (osteogenic treatment).~     Recent studies in children with cerebral palsy but also OI suggest that Whole Body Vibration~     Training (WBVT) improves mobility and also bone strength. No randomized controlled trials~     exist in OI children. This randomized controlled pilot study assesses the effect of 5 months~     WBVT (2 x 9min/day) on muscle function, mobility, bone structure and density. 24 children >5~     years with OI type 1 and 4 with limited mobility (CHAQ Score ≥0.13) will be randomized into a~     WBVT group and a control group matched by gender and pubertal stage. Main outcome measure is~     the change in tibial volumetric BMD, secondary outcomes include a variety of bone, mobility~     and dynamic muscle function variables.~   "
41059|NCT03029299|"~     BioFire Diagnostics, LLC (BioFire; a bioMerieux company), has developed a multiplexed~     molecular-based in vitro diagnostic platform for infectious disease testing known as the~     FilmArray. The FilmArray Respiratory Panel (RP) EZ is a test designed for use with the~     FilmArray 2.0 EZ Configuration instrument that identifies common bacterial and viral~     microorganisms associated with respiratory tract infections from a nasopharyngeal swab (NPS)~     specimen collected in viral transport media (VTM). The RP EZ was granted CLIA-waived~     classification by the FDA in October 2016 and is the first highly-multiplexed molecular test~     to receive this designation.~      The purpose of this study is to measure patient outcomes following implementation of the RP~     EZ test and to also gather data about physician office workflow and user interactions with~     the device. These data will be used to understand how the adoption of such tests may~     influence patient care in the CLIA-waived setting.~   "
41060|NCT03029286|"~     This trial will test a decision support web based intervention for women at increased risk~     for breast cancer due to breast density and other risk factors (age, race/ethnicity, family~     history of breast cancer, history of prior breast biopsies), and to consider MRI and/or~     chemoprevention to manage their breast cancer risk.~   "
41088|NCT03028922|"~     This clinical investigation is a prospective, multi-centre study to evaluate bone gain after~     horizontal augmentation using creos xenogain bone graft substitute. Patients included in the~     study are in need of a GBR procedure prior to implant placement in the premolar and posterior~     region of the mandible.~   "
41089|NCT03028909|"~     The purposes of this study are to determine if MEDI8852 administered with standard of care~     (oseltamivir) will reduce the time to normalization of respiratory function for adults who~     are hospitalized with influenza caused by Type A strains and to determine if MEDI8852 has an~     acceptable safety profile in adults who are hospitalized with influenza caused by Type A~     strains.~   "
41061|NCT03029273|"~     TCR-T cell therapy experienced a breakthrough for treating tumors in recent years. Phase I /~     II trial of NY-ESO-1-specific TCR-T treatment for synovial sarcoma and melanoma conducted by~     the Rosenberg team at the National Cancer Institute showed that 61% Synovial cell sarcoma and~     55% melanoma had therapeutic responses. Another report of a phase I / II clinical trial for~     multiple myeloma showed that 20 patients received high affinity anti-NY-ESO-1 and LAGE-1~     specific TCR-T treatment, 16 of them (80%) had the average progression-free survival of 19.1~     months with minor side effect. These achievements indicate that TCR-T cell therapy can target~     a variety of tumors including solid tumors without any severe side effects found in CAR-T~     trials.~      This study is mainly focused on tumor testis antigen (Cancer-Testis Antigen), because it is~     not expressed in normal cells. NY-ESO-1 antigen is commonly expressed in 10-50% of melanoma,~     lung, liver, esophageal, breast, prostate, bladder, thyroid and ovarian cancer cases, 60% of~     multiple myeloma cases, and 70-80% of synovial cell sarcoma. Approximately 700,000 new cases~     of lung cancer are identified each year in China, 70% of them die within one to two years~     after diagnosis due to the lack of effective treatment. To address that unmet needs, our~     TCR-T treatment targets non-small cell lung cancer with NY-ESO-1 antigen expression.~      This study will investigate the safety and tolerability of TAEST16001 (TAEST: TCR Affinity~     Enhancing Specific T cell Therapy, autologous T cells transduced with affinity enhanced~     NY-ESO-1 TCR) cell therapy in subjects with NSCLC who have received prior therapy for their~     disease but their disease has progressed or relapsed.~   "
41062|NCT03029260|"~     This study aims to compare the effect of tension neural mobilization versus sliding neural~     mobilization of the peroneal nerve on the heat and cold threshold, on pressure pain threshold~     and on flexibility both in the dominant lower limb (subjected to mobilization) and the~     non-dominant lower limb (not subjected to mobilization) in healthy young participants.~   "
41063|NCT03029247|"~     This will be an open-label, randomized, parallel-group study in hemodialysis-dependent (HD)~     subjects with anemia associated with chronic kidney disease (CKD), designed to compare the~     effects of daprodustat to epoetin alfa on blood pressure (BP).~      After a 4-week screening and a 4-week erythropoesis-stimulating agent (ESA) washout period,~     on Day 1 subjects will be randomized 1:1 and stratified by prior ESA dose before they undergo~     Acute Challenge 1, a single dose challenge to compare the acute effects on BP of the highest~     planned once-daily maintenance dose of daprodustat (24 milligrams [mg]) to the highest~     starting dose of epoetin alfa (100 international units [IU]/kilograms [kg]). This will be~     followed by an 8-week hemoglobin (Hgb)-maintenance period, where doses of either daprodustat~     or epoetin alfa will be administered and adjusted. At the end of Hgb maintenance period, on~     Day 57 an Acute Challenge (number 2) will be repeated utilizing the same treatment as of~     Acute Challenge 1; there will be a follow-up visit within 14+/-3 days after completing~     treatment. The total duration of subject involvement is up to 18 weeks (Screening to~     Follow-up).~   "
41064|NCT03029234|"~     The purpose of this study is to evaluate the safety, tolerability and overall response rate~     of carfilzomib in combination with dexamethasone for the treatment of multiple myeloma in~     China.~   "
41065|NCT03029221|"~     This project evaluates Real Relationships, a program provided by the Children's Aid Society~     (CAS) in Clearfield County, and funded through the DHHS Healthy Marriage (and Responsible~     Fatherhood) program. Research questions focus on recruitment and retention of participants,~     and short- and long-term participant outcomes associated with different formats for offering~     the program.~   "
41066|NCT03029208|"~     The purpose of this multi-center study is to evaluate the efficacy and safety of daprodustat~     in subjects with anemia associated with CKD.~   "
41067|NCT03029195|"~     The cleft lip and palate (CLP) is the commonest craniofacial anomaly worldwide. Nasoalveolar~     molding (NAM) therapy has emerged in the management of CLP as an early presurgical~     intervention to provide symmetry to severely deformed nasal cartilage, achieve projection to~     the flattened nasal tip, provide nonsurgical elevation for the columella, improve alignment~     of the alveolar ridge, reduce the cleft gap and it could significantly reduce the number of~     secondary surgeries. Despite that NAM therapy is becoming the treatment option for early~     cleft care, there is growing debate about its efficacy due to lack of quantitative assessment~     of these findings. To provide the highest levels of clinical evidence on NAM therapy, there~     has been international call for Randomized Controlled Clinical Trials.~      Statement of the problem: lack of quantitative data about the efficacy of the NAM therapy for~     unilateral CLP.~      Aim of the study: is to develop a standardized non-invasive quantitative assessment for two~     different techniques of the NAM therapy in Egyptian infants that involves 3D laser~     scanning/CAD analysis for maxillary geometry, and nasal anthropometric analysis.~      Methods Trial design: Prospective randomized controlled clinical trial (RCT). Settings: The~     RCT will be performed through two phases; (Phase I: A controlled pre and post-RCT that will~     be designed for the quantitative evaluation of the NAM therapy on the maxillary geometry),~     and (Phase II: A post-test RCT will be designed for the quantitative evaluation of the NAM~     therapy on the nasal anthropometry and comparing the outcome with the nasal anthropometry~     that will be performed to age matched Egyptian norms).~      Participants: 30 Egyptian infants with nonsyndromic UCLP will be randomly allocated to study~     groups (Group I, n=15) that will undergo NAM therapy before the primary surgical repair, and~     control group (n=15) that will undergo the primary surgical repair without NAM therapy. And~     15 Egyptian infants will act as norm group.~      Follow-up: (phase I- T0: before NAM, T1: after 1 month and T2: before surgery). (Phase II-~     T0: 10 days after surgery, and T1: 6 months after surgery).~   "
41068|NCT03029182|"~     The study will evaluate the utility of hypoxic exercise training to improve cardiovascular~     and metabolic health among obese breast cancer survivors. While participants exercise, a~     lower fraction of inspired oxygen will be used to simulate a higher altitude. This approach~     removes the mechanical strain needed to sustain moderate-to-vigorous exercise intensity which~     is believed to support exercise tolerance. Participants are randomized to either the~     treatment (walking+simulated-altitude) or control (walking under normoxic conditions).~   "
41069|NCT03029169|"~     Arrhythmias accompany septic shock in increased rates than in other ICU cohorts and their~     presence and management are related to patient´s prognosis. 1c class antiarrhythmics are~     seldom administered in intensive care due to a dose dependent toxicity published in case~     reports and unfavourable outcome reported in a few prospective trials done on cardiology~     patients. The papers on 1c class antiarrhythmics do not take into consideration a complex~     haemodynamic assessment using echocardiography. The authors have recently presented a~     retrospective study on SV arrhythmias in septic shock patients demonstrating favourable~     effect and safety of propafenone which showed higher antiarrhythmic efficacy than amiodarone.~   "
41090|NCT03028896|"~     The 90° rotation technique is known to improve the success rate of conventional LMA but its~     effect in LMA FlexibleTM is not known. We tried to find if 90° rotation technique could~     increase the first attempt success rate of the insertion of LMA FlexibleTM compared to~     standard technique.~   "
41091|NCT03028883|"~     In this retrospective cohort study, we plan to examine the relationship between buprenorphine~     dose adjustments, gestational age, urine buprenorphine levels and the rate of neonatal~     abstinence syndrome in opioid-maintained pregnant women~   "
41070|NCT03029156|"~     Background: The bronchodilator therapy is an essential component of the management of asthma~     exacerbation. The delivery of bronchodilators to the lungs in asthma exacerbations is usually~     achieved through nebulization (creating small particles to be inhaled). The commonly used~     nebulizer device is a small volume jet nebulizer which has not been consistently reliable in~     delivering bronchodilator therapy. The Aeroneb nebulizer device is a FDA approved device~     which produces consistently respirable sized particles which could potentially result in~     better bronchodilator effect than the standard jet nebulizer.~      Aim: To study whether the Aeroneb nebulizer is more effective than a small volume jet~     nebulizer in delivering bronchodilators during a severe asthma exacerbation.~      Experimental design: Patients will be randomized (like a flip of a coin) to receive~     bronchodilator therapy as per the emergency room protocol either via small volume jet~     nebulizer or Aeroneb nebulizer.~      Subjects: Adult patients between age of 18 and 55 years who present to the emergency room~     with severe asthma exacerbation with peak expiratory flow rate <50% of predicted.~      Study procedure: When enrolled in the study and after randomization, we will then collect~     data that is standard for the hospital like heart rate, blood pressure and breathing indices~     and also some non-routine things like some scoring scales for shortness of breath and serial~     measurements of peak expiratory flow rate. We anticipate that the Aeroneb device will be more~     effective in delivering bronchodilator medication and thus more effective in managing asthma~     exacerbations.~   "
41071|NCT03029143|"~     The purpose of this study is to investigate the effect of vedolizumab intravenous (IV) dose~     optimization on mucosal healing compared with the standard vedolizumab IV dosing regimen at~     Week 30 in participants with ulcerative colitis (UC) and high vedolizumab clearance, based on~     a Week 5 predefined serum vedolizumab concentration threshold (< 50 µg/mL) and who are Week 6~     non-responders.~   "
41072|NCT03029130|"~     This study evaluates the use of extending time of continual urinary drainage (using~     transurethral foley catheter) for patients with early failures of vesicovaginal fistula~     repairs. Half of those included will be randomized to replacement of foley catheter for a~     length of 14 additional days, while the other half will be discharged (no intervention). Both~     groups will be examined for outcomes at 3 months post-repair.~   "
41073|NCT03029117|"~     It's prospective Cohort study to compare maternal and fetal outcomes in pregnant females~     between corrected and uncorrected rheumatic valve lesions~   "
41074|NCT03029104|"~     This study will assess changes in visual acuity and corneal symmetry after corneal collagen~     cross-linking (CXL) of asymmetric corneas.~   "
41075|NCT03029091|"~     The purpose of this study is to test the safety and effectiveness of Losartan potassium in~     subjects with Eosinophilic Esophagitis (EoE), both those with a connective tissue disorder~     (CTD) and those without a CTD.~   "
41076|NCT03029078|"~     Our trial try to eradicate digestive tract colonization of patient harboring Extreme Drug~     Resistant (XDR) bacteria by performing a fecal transplantation.~   "
41077|NCT03029065|"~     This study aimed to detect cell free DNA (cfDNA) in the cerebrospinal fluid and plasma, and~     to determine whether cfDNA can be used for concomitant diagnosis to improve the treatment~     efficacy and prognosis of patients with brain (meningeal) metastasis by monitoring~     tumor-related genetic mutations in cfDNA in the plasma and cerebrospinal fluid.~   "
41078|NCT03029052|"~     Patient's discharge from hospital is associated with iatrogenic events for 12 to 17% of~     patients. This risk may be linked with discontinuity of care between hospital physicians and~     Primary Care Physician (PCP). The investigators aim to assess in this study the impact of~     medication reconciliation at discharge associated with a patient's counseling session, both~     provided by a pharmacist, on patient's care after discharge. To demonstrate the interest of~     medication reconciliation at discharge we expect a reduction by 15% of the number of~     prescription changes not maintained by the PCP after discharge.~   "
41079|NCT03029039|"~     Sepsis represents a serious public health issue characterized by a complex inflammatory~     response. In addition to their hemostatic role, platelets display inflammatory functions by~     secreting a variety of immunomodulatory factors and interacting with circulating immune~     cells. The investigators postulate that, in severe sepsis, platelets become activated and~     release amounts of different soluble inflammatory molecules that contribute to~     sepsis-associated inflammation. First, the investigators propose to assess whether severe~     sepsis impairs the ability of platelets to release soluble CD40L (sCD40L), an powerful~     platelet-derived immunomodulatory molecule, in ICU patients with S. aureus documented~     infection, ICU patients with documented infection involving other bacterial species, compared~     to ICU patients with inflammation of noninfectious origin and healthy blood donors. Then, the~     investigators wish to assess whether the bacterial species affects the release of platelet~     sCD40L and by an extensive screening of platelet soluble factors, the investigators propose~     to set up profiles of inflammatory molecules associated with the type of infection. Finally,~     the investigators will analyze platelets' activation state and their association with~     circulating immune, according to the type of infection. Therefore, this project is expected~     to assess to which extent the platelet inflammatory function is super-activated in severe~     sepsis and to identify new platelet-related biomarkers of sepsis.~   "
41080|NCT03029026|"~     Aortic stenosis (AS) is the most common valvular heart disease. Once symptomatic with severe~     AS, outcome is poor unless the valve is replaced surgically or via transcatheter aortic valve~     replacement (TAVR). Transthyretin amyloid (ATTR) deposits are common in the heart muscle in~     up to 25% of octogenarians, and after an asymptomatic period of unknown duration, cause overt~     heart failure and arrhythmias in a proportion of cases. The prevalence and impact of covert~     ATTR amyloidosis in elderly individuals with AS are unknown. Detection would avoid~     misdiagnosis, guide treatment and, potentially, improve outcomes. Recent data have shown that~     echocardiography, cardiovascular magnetic resonance (CMR), computed tomography (CT), and DPD~     scintigraphy, can identify ATTR amyloid deposits, but the clinical performance of these~     various tests is unknown.~      This study will investigate elderly patients with symptomatic severe AS using imaging to~     explore ATTR amyloid in AS and determine its prevalence and impact on outcome.~      The investigators aim to recruit a total of 250 patients aged 75 or older being considered~     for intervention for severe AS. The prevalence of cardiac amyloid will be assessed in three~     arms (sAVR, TAVI and medical therapy, with a likely patient ratio of 50:150:50), using five~     investigation modalities - all cohorts (echocardiography and DPD scintigraphy); sAVR cohort~     (biopsy and CMR); TAVI cohort (EqCT); medical therapy only cohort (as per work-up/trial prior~     to no intervention decision).~      The primary outcome measure is patient mortality. Secondary outcomes measures are major~     adverse cardiovascular events, length of stay, pacemaker implantation, ECV measured by EqCT~     and CMR.~      Follow up will be at 1-year with clinical echocardiogram (for sAVR and TAVI patients) and/or~     telephone interview for all patients (if not carried out in person at the time of the~     echocardiogram).~   "
41093|NCT03028857|"~     The goal is to determine if providing a nutritional supplement, phosphatidylcholine, to~     pregnant women improves early brain development with improved brain-related development~     during the first four years of life. Participating pregnant women will receive either~     phosphatidylcholine or a placebo from approximately 16 weeks gestation through birth. The~     primary outcome is the child's behavior at four years of age as reported by the primary~     caregiver. Secondary outcomes include motor development, socio-emotional development,~     language development, and cognitive development. Potential contributors beyond the~     supplement, including maternal stress and placental function will also be assessed.~   "
41094|NCT03028844|"~     Randomised Crossover Trial in Preterm Infants less than 32 weeks to assess Music therapy and~     sucrose versus sucrose on stress~   "
41095|NCT03028831|"~     Alaska native people (AN) have the highest recorded incidence and death rate from colon~     cancer in the world (>90:100,000). We hypothesize that the AN, despite their high consumption~     of anti-inflammatory and antineoplastic n-3 fish oils, are at increased risk of colon cancer~     because of colonic butyrate deficiency resulting from their remarkably low consumption of~     fiber-containing foods. We hypothesize that fiber supplementation of their usual diet will~     result in a bloom of butyrate producing microbes in the colon, resulting in increased~     butyrate production, which will suppress their high microbial secondary bile acid production,~     antagonize the actions of other food (smoked fish) and environmental carcinogens (tobacco,~     alcohol), and interact with the high circulating levels of n-3 fish oils to suppress colonic~     inflammation and cancer risk. In order to investigate this, we will conduct a randomized~     double-blinded 4-week clinical trial in up to 100 randomizable healthy, middle-aged AN~     undergoing screening colonoscopy, with the objective of obtaining 60 completed interventions.~     The interventions will consist of either a high-dose soluble fiber supplement given as a~     drink, together with their usual diet which currently contains about 15g total fiber/d, or to~     a control digestible starch drink plus their usual diet. The primary endpoint will be a~     clinically significant reduction in Ki67 proliferative colonic mucosal biomarkers of cancer~     risk. Microbiome and metabolome mechanisms responsible for the anticipated changes in mucosal~     biomarkers will also be investigated. Our results in extreme risk AN will be further~     evaluated by comparison to similar measurements previously made in minimal risk rural~     Africans and intermediate risk African Americans. Our results will be used to provide the~     scientific basis for a definitive large-scale high-fiber supplementation study (to achieve~     >50g total fiber/d) to suppress adenomatous polyp recurrence following colonoscopy.~   "
41096|NCT03028818|"~     To inform the feasibility of conducting a study to test different temperature thresholds at~     which clinicians deliver interventions to reduce fever (i.e. antipyretic interventions) in~     critically ill children with fever due to infection.~   "
41097|NCT03028805|"~     This is a fully automated randomized trial with two randomization branch-points. The first is~     inclusion of disease-specific orders in the admission orders based on a predictive model~     using real-time data. The second is the use of dynamic orders that are end-user tested rather~     than static orders designed by a committee. The primary hypothesis is that automatic~     inclusion of disease specific orders with admission orders will improve adherence to~     guidelines for patients with COPD. The secondary hypothesis is that clinical and operational~     outcomes will improve, thereby improving value.~   "
41098|NCT03028792|"~     This study aims to test the efficacy and feasibility of administering a computerized~     attention training program targeting clinical levels of anxiety in Latino youth between the~     ages of 8-17. 52 youth from Imperial County, a rural and predominantly Latino region, will be~     randomized to receive either 1) a 12-session attention modification program (AMP) or 2) an~     attention condition program (non-active treatment). Clinical assessment of symptom severity~     will be conducted before, during, and after treatment. We hypothesize that at the end of~     treatment, children who receive the active intervention (AMP) will show (1) decreased~     attention bias to anxiety-related triggers using an independent measure of attention bias to~     assess change and (b) reduced anxiety severity. We also hypothesize that this study will be~     feasible, tolerable, acceptable, and safe in this underserved sample of Latino youth. This~     study is an initial step towards demonstrating the feasibility of implementing a novel~     computerized attention training program in anxiety in underserved community samples.~   "
41099|NCT03028779|"~     Implementation of Fast-track surgery for total hip replacement and total knee replacement and~     evaluation of the risks and benefits for the patients.~   "
41100|NCT03028766|"~     This trial is to determine what dose of a drug called AZD1775 can safely be given in~     combination with cisplatin before surgery and with chemo-radiotherapy after surgery in~     patients with Head and Neck Cancer. The Investigators will also get some preliminary~     information regarding the effectiveness of this combined treatment.~   "
41101|NCT03028753|"~     The investigators are trying to determine if using a bladder scanner (type of ultrasound) to~     check how much urine is left in the bladder is the same as checking that volume with a~     catheter (tube that goes into your bladder to drain urine). After urogynecologic surgery, the~     investigators perform a voiding trial. Water is put into the participant's bladder through~     the catheter (tube draining your bladder). The catheter is then removed and the participant~     is asked to empty their bladder. After that, the investigators will use the bladder scanner~     (ultrasound) to see how much urine is left in the participant's bladder. After the~     ultrasound, the investigators will pass a very small catheter (tube) into the bladder to take~     out the remaining urine. The investigators will then compare the amount obtained from the~     catheter to the ultrasound amount. This will also help the investigators to figure out if~     they need to check how much urine is left in a patient's bladder after the voiding trial.~   "
41102|NCT03028740|"~     The AURORA study will be conducted to confirm the efficacy and safety of cenicriviroc (CVC)~     for the treatment of liver fibrosis in adult subjects with NASH.~   "
41103|NCT03028727|"~     Laser therapy has been proposed as a novel treatment option in controlling subgingival~     microorganisms. This randomized controlled clinical trial evaluates the effect of 980nm diode~     laser as an adjunct to scaling and root planing (SRP) in the management of chronic~     periodontitis (CP).~   "
41104|NCT03028714|"~     Metabolic risk factors, such as central obesity, increase the risk of chronic diseases in~     adulthood and are prevalent in many university students. Increasing the knowledge about~     healthy nutrition and physical activity can positively impact students' lifestyle and prevent~     weight gain. This study aims to investigate the impact of online educational methods on~     nutrition knowledge, dietary habits, BMI, and physical activity in a sample of university~     students in the UK. Anthropometric measurements will be assessed and questionnaires will be~     completed at the beginning and at the end of the study. Written consent will be sought, the~     voluntary nature of participation will be emphasized while anonymity and confidentiality will~     be strictly maintained.~   "
41106|NCT03028688|"~     Millions of patients undergo upper GI endoscopy in the United States each year. A large~     number of these patients have anesthesia to assist with their comfort during the procedure.~     The majority of patients do not have a protected airway during the procedure, meaning there~     is no endotracheal tube. Instead the current standard of care is to give supplementary oxygen~     via nasal cannula. Because patients are deeply sedated or have general anesthesia there is a~     risk for low oxygen saturation during the procedure, which presents a significant patient~     safety issue. The purpose of the clinical trial is compare the current anesthesia standard of~     care against high flow nasal cannula oxygen delivery during anesthesia. The investigator's~     hypothesis is that high flow nasal cannula oxygen delivery will decrease the frequency with~     which patients experience hypoxemia during anesthesia for upper GI endoscopy.~   "
41107|NCT03028675|"~     Twenty subjects (10 patients and 10 age-matched control volunteers) will be recruited for~     this study. MRI scans will take place on a 3T MRI Scanner (Skyra or Prisma, Siemens Medical~     Solutions) located at The NYU Center for Biomedical Imaging. MRI scans will consist of a~     1-hour brain scan for both patients and controls. In the first 6 months of the study,~     investigators will develop and test a uMT-based APT imaging for brain tissue pH measurement~     and use a hypercapnia paradigm to validate the tissue pH changes between breathing room air~     and 5% CO2 (by increasing tissue acidity) inhalation. With implementation of hypercapnia MRI,~     pH-weighted imaging will be validated for its robustness and reproducibility.~   "
41108|NCT03028662|"~     This is an experimental study in which the efficacy of three psychophysiological intervention~     modalities based on retrieval-extinction procedures is analyzed.~   "
41109|NCT03028649|"~     The purpose of this study was to verify the effect of 12-week with β-hydroxy-β-methylbutyrate~     (HMB) and a placebo (PLA) supplementation on body composition, anaerobic and aerobic~     capacity, as well as concentrations of the selected biochemical blood markers in trained~     athletes, in a randomised, double-blind, placebo-controlled crossover trial.~   "
41110|NCT03028636|"~     A prospective, open label post market registry to collect Patient Reported Outcomes in an~     online data capture registry, maintained by Pelvalon, of women with fecal incontinence~     exiting the LIBERATE study (NCT02428595) continuing to use the Eclipse System for bowel~     control.~   "
41111|NCT03028623|"~     The objective of this study is to evaluate the feasibility and safety of salpingectomy versus~     standard tubal ligation in women undergoing surgical sterilization at the time of a planned~     cesarean delivery. Salpingectomy is currently being investigated as a potential strategy for~     ovarian cancer prevention. While this procedure is currently performed during hysterectomies,~     its feasibility at the time of cesarean delivery is not well established.~      This randomized, prospective clinical trial will compare the two sterilization methods to~     demonstrate that salpingectomy compared with standard tubal ligation at the time of cesarean~     delivery will not result in increased operative time, blood loss or other complications. This~     study is necessary to promote salpingectomy as a standard sterilization method during~     cesarean deliveries.~   "
41112|NCT03028610|"~     Prospective, interventional, single-center, longitudinal, single-arm pilot study to evaluate~     pregnancies following the Acessa™ treatment of uterine myomas in women who desire future~     childbearing~   "
41113|NCT03028597|"~     The objective of this study is to reduce the effects of stereotype threat on the adherence of~     African American patients with hypertension.~      The specific aims of this study, which employs a values affirmation intervention, are to:~        1. Compare the effects of the values-affirmation exercise to a control condition on~          antihypertensive medication adherence in African American patients with uncontrolled~          hypertension across three clinical settings,~        2. Compare the effects of the values-affirmation exercise on antihypertensive medication~          adherence in African American patients and white patients with uncontrolled hypertension~          and similar socioeconomic characteristics, and~        3. Evaluate the intervention for widespread dissemination using the RE-AIM (reach,~          effectiveness, adoption, implementation and maintenance) framework~   "
41114|NCT03028584|"~     This is a two part observational study evaluating the feasibility of implementing an~     EHR-based model within a community oncology practice.~   "
41115|NCT03028571|"~     The investigators will test the null hypothesis that there will be no changes in the~     insulin-mediated suppression of endogenous glucose production (EGP) in response to autonomic~     blockade. To test this hypothesis, the investigators propose to determine the role of the~     autonomic nervous system in hepatic insulin resistance.~   "
41116|NCT03028558|"~     Electronic cigarettes (EC) are battery powered nicotine delivery devices that aerosolize~     nicotine and other flavor constituents. Despite the increasing use of EC, little attention~     has been paid to their possible adverse effects on human health. Theoretically, the risk~     relates to nicotine per se and/or the propellants or contaminants in the EC aerosol. The~     hypothesis underlying the proposal is that chronic EC smoking disorders the biology of the~     oral epithelium, the first cell population exposed to inhaled EC vapors. Using a~     cross-sectional, cohort-comparison of EC smokers compared to age-, gender- and~     ethnicity-matched never smokers, the investigators propose to assess the oral epithelium~     obtained by punch biopsy or brushing from 100 EC smokers and 25 nonsmoker controls. The EC~     study cohort will be restricted to young adults (age 21-35 yr) with no prior history of~     tobacco smoking, but who have smoked EC for >6 months.~   "
41127|NCT03028415|"~     To demonstrate that AMPLEX is non-inferior to autogenous bone graft (ABG) for bone fusion in~     a population indicated for single, double, or triple hindfoot arthrodesis or ankle~     arthrodesis surgery with supplemental graft material.~   "
41128|NCT03028402|"~     This study aims to determine to what extent patient-specific factors, iatrogenic factors, and~     biomechanical factors influence cervical spine mechanics after single-level and two-level~     arthrodesis.~   "
41129|NCT03028389|"~     To investigate whether limb remote ischemic preconditioning (LRIP) could safely decrease the~     incidence of delirium in elderly patients after non-cardiac surgery.~   "
41243|NCT03026881|"~     Fluzoparib is an oral potent, selective PARP-1 and PARP-2 inhibitor; Apatinib is an oral~     selective VEGFR inhibitor. This open-label, dose finding phase I trial studies the~     tolerability and the best dose of Fluzoparib in combination with apatinib and paclitaxel and~     to see how well this three drugs work together in the treatment of patients with recurrent~     and metastatic gastric cancer who progress following first-line therapy. The safety and~     efficacy of fluzoparib in combination with apatinib and paclitaxel will be explored.~   "
41117|NCT03028545|"~     In the recent context of deinstitutionalization and longitudinal studies pointing to a large~     number of positive long-term outcommes for people affected by a psychiatric disorder~     (schizophrenia, bipolar disorder, eating disorder, severe personality disorder, etc.), the~     possibility of overcoming the consequences of a psychiatric pathology emerges as a solid~     fact. Therefore, the existence of this possibility calls for the identification of the~     determinants underlying of the various outcomes over time of those affected by a severe~     psychiatric disorder, in particular those likely to underpin the most positive developments.~      While it is well known from a medical point of view that certain dimensions affect the~     prognosis of persons affected by a severe psychiatric disorder (such as the persistence of~     negative symptoms or cognitive disorders in schizophrenic disorders), prognosis from a purely~     medical perspective (and putting aside the role of the person and his environment) seems to~     be able to account only for a modest proportion of the prognosis of people affected by a~     serious psychiatric disorder.~      It is this fact that has gradually led to the emergence of complementary models capable of~     enriching the understanding of the determinants of the future of people affected by a severe~     psychiatric disorder, in particular models inviting to separate becoming of the person from~     the  psychiatric disorder to take into account the personal role of the person in his or~     her own healing. This perspective is the recovery perspective.~      Recovery process is defined as a personal trajectory which includes the person's experiences~     and the reactions of his / her environment following the installation of a psychiatric~     disorder, which can support a mode of release of the status of psychiatric patient.~     Recovery thus implies an approach underpinned by the understanding of the human response to~     pathology (Noiseux) and, one might add, of its environment.~      This definition of recovery is also subjective because it is tied to very personal~     experiences and related to the person's own norms as to what it means to be re-established.~     The subject engages in a long, progressive process, without return to the previous state. In~     a dynamic response to an equilibrium perturbed by the disease, we are interested in restoring~     a new equilibrium rather than the factor triggering its loss. Recovery is seen as a~     trajectory punctuated by decisive moments on a background of progressive change, this process~     oscillates between awareness, ambivalence and forward shift.~      However, while these studies point to a number of crucial dimensions involved in the recovery~     of a severe psychiatric disorder, one of the important limitations of these studies is the~     distance from any psychopathological consideration, thus setting aside the possibility of~     specific processes of recovery depending of the pathology. The identification of recurrent~     experiential logics specific to the various psychiatric disorders therefore appears to be an~     important field of investigation. It would potentially be able to guide the development of~     new therapeutic devices based on the recovery model.~   "
41118|NCT03028532|"~     Clomiphene (Clomid) is a drug FDA approved to treat female infertility, however, it is often~     used by men in an off-label setting to both treat male infertility and in a multitude of~     sports disciplines to increase performance.~      Study Objectives:~        -  Determine detection windows for clomiphene and its metabolites in urine following a~          medium-term administration~        -  Understand the effect of clomiphene administration on luteinizing hormone (LH),~          follicle-stimulating hormone (FSH), and serum testosterone (T) concentrations in a~          longitudinal manner~        -  Identify changes in current steroidal module of Athlete Biological Passport~   "
41119|NCT03028519|"~     This study will evaluate serum vitamin D (25(OH)D) and serum leptin levels at the time of~     diagnosis of ovarian, primary peritoneal, and/or fallopian tube cancer as well as vitamin D~     receptor mutation status (FokI SNP genotype). The study will evaluate the impact of vitamin D~     repletion on serum vitamin D levels, serum leptin levels, and treatment-related morbidity in~     these patients.~   "
41120|NCT03028506|"~     The purpose of the proposed study is to assess the distribution of carbohydrates and fat in~     the diet of women with type 1 diabetes during pregnancy. More specifically, it will look at~     the distribution of carbohydrate in the diet during weeks 29-32 of pregnancy. The~     carbohydrate distribution and fat content of the meal will be compared to maternal glucose~     control, preprandial glucose levels, and the percentile for weight of the infant at birth. In~     addition, each meal and snack will be classified as low-moderate fat or high fat.~   "
41121|NCT03028493|"~     This study serves to test a previously evaluated falls prevention intervention recommended by~     the Centers for Disease Control and Prevention, entitled the Study of Accidental Falls in the~     Elderly (SAFE) Health Behavior and Exercise Intervention, to evaluate if the intervention is~     accessible to older adults with low vision receiving services from the Southeastern Blind~     Rehabilitation Center (SBRC). This study also serves to pilot a version of the SAFE~     intervention that has been adapted to be accessible for individuals with low vision at SBRC.~   "
41122|NCT03028480|"~     This study is a special drug use investigation program of NUCALA (a brand name for~     Mepolizumab) administered subcutaneously (SC). In this study the information regarding the~     safety and effectiveness of long term use of NUCALA after subcutaneous injection will be~     collected from Asthma subjects in daily clinical practice. The observation period per subject~     will be 52 weeks from the initiation of NUCALA treatment with follow-up investigation for 2~     years after the observation period. NUCALA is a registered trademark of the GlaxoSmithKline~     [GSK] group of companies~   "
41123|NCT03028467|"~     This is a randomized, double-blind, parallel group, 3 dosage level, placebo-controlled, Phase~     1/2 study designed to evaluate the pharmacokinetics, safety, tolerability, and efficacy of~     the monoclonal antibody GSK3196165, in Japanese subjects with active moderate-severe~     rheumatoid arthritis (RA) despite treatment with methotrexate(MTX). The subjects will receive~     GSK3196165 in combination with methotrexate therapy for the 12 weeks of treatment period.~     Approximately 55 subjects will be screened to achieve 40 randomized subjects, so as to have~     approximately 10 subjects in each treatment group.~   "
41124|NCT03028454|"~     The objective of the study is to determine whether five days of ginger (Zingiber officinale)~     supplementation is effective at reducing muscle soreness and improving muscle function~     following downhill running. Long-distance running is often associated with acute muscle pain,~     swelling, and reduced muscle functioning, and consequently, many runners utilize~     non-steroidal anti-inflammatory drugs (NSAID). NSAID use is associated with gastrointestinal~     side-effects such as stomach discomfort, nausea, dyspepsia, asymptomatic ulcers, and~     symptomatic ulcers that, although rare, can be fatal. Ginger is a botanical compound that is~     Generally Recognized as Safe by the Food and Drug Administration (FDA). Evidence from~     osteoarthritis, dysmenorrhea, and resistance-training models indicate that ginger is~     effective at reducing general pain and muscle soreness. Therefore, this study will supplement~     60 runners with roughly 1.5 g/day of ginger root or a placebo for 2 days prior to, the day~     of, and 2 days after downhill running. Participants will be evaluated for muscle soreness and~     function before and after the downhill run.~   "
41125|NCT03028441|"~     This study is a randomized, double-blinded, Phase 1, placebo- controlled, and dose comparison~     trial to evaluate the safety, immunogenicity and schedule of MV-CHIK. Two dosage levels and 3~     immunization schedules will be evaluated. This study will enroll up to 180 healthy subjects~     aged 18 to 45 years.Study duration is approximately 22 months. Subject participation duration~     is approximately 8-13 months. The primary objectives are to evaluate the safety and~     tolerability of 5 x 10^4 TCID50 and 5 x 10^5 TCID50 MV-CHIK and placebo following two~     consecutive intramuscular injections and to assess the CHIKV serum plaque reduction~     neutralization test (PRNT50) antibody responses to 5 x 10^4 TCID50, 5 x 10^5 TCID50 of~     MV-CHIK or placebo on day 29 following the first dose.~   "
41130|NCT03028376|"~     The PreTBI II study aims to investigate the diagnostic potential of prehospital S100B and~     GFAP measurements in prediction of need for neurosurgical observation and/or intervention in~     moderate TBI patients, to rule-in high-risk patients. Ultimately to select patients who will~     benefit from neuro surgical expertise in specialized departments and thereby possibly better~     patient outcome. Hopefully also minimize treatment delay, secure optimal resource consumption~     and streamline patient courses by predicting the presence of neurotrauma.~      Hypotheses:~        1. A prehospital serum S100B level > 0,10 microgram/L and expectedly above a certain and~          currently unknown cut-off value indicates the need for neurosurgical observation and/or~          intervention in moderate TBI patients.~        2. A prehospital serum GFAP level above a certain and currently unknown cut-off value can~          significantly predict a need for urgent neurosurgical observation and/or intervention in~          moderate TBI patients.~        3. Biomarker dynamics between prehospital and in-hospital biomarker values of S100B and~          GFAP can significantly predict a need for urgent neurosurgical observation and/or~          intervention.~        4. Biomarker dynamics between prehospital and in-hospital biomarker values of S100B and~          GFAP can significantly predict hospital course and outcome of patients with moderate~          TBI.~   "
41131|NCT03028363|"~     The objectives of this study are to assess the safety and efficacy of Olumacostat Glasaretil~     Gel compared to vehicle in patients with acne vulgaris~   "
41132|NCT03028350|"~     The purpose of this phase 2 study is to assess the safety and efficacy of oral ifetroban for~     the treatment of aspirin-exacerbated respiratory disease (AERD). AERD is a disease that~     involves asthma, recurring nasal polyps, and respiratory reactions to aspirin and other~     nonsteroidal anti-inflammatory drugs.~   "
41133|NCT03028337|"~     The goal of this clinical research study is to learn whether delivering spine radiosurgery in~     a single large dose is better than delivering spine radiosurgery over 3 smaller doses.~      Researchers also want to learn about the effects of a single dose on participant's symptoms,~     pain, and quality-of-life.~   "
41134|NCT03028324|"~     The purpose of this study is to assess the influence of transcranial magnetic stimulation~     (TMS) on speech performance in individuals with primary progressive apraxia of speech.~   "
41135|NCT03028311|"~     You are being asked to take part in this study because you have liver cancer or cancer that~     has spread to the liver are scheduled for SIR-Spheres treatment (Yttrium-90 radioembolization~     treatment).~      The goal of this clinical research study is to learn about the safety of giving SIR-Spheres~     treatment to patients with liver cancer in the same session rather than over 2 sessions,~     which is the standard of care.~      This is an investigational study. The SIR-Spheres is delivered using FDA approved and~     commercially available methods. It is investigational to learn if the procedure can be safely~     performed in a single session.~      Up to 12 participants will be enrolled in this study. All will take part at MD Anderson.~   "
41136|NCT03028298|"~     Each year, approximately 30,000 people in the United States suffer an intra-cranial~     hemorrhage due to aneurysmal rupture. Of those surviving the initial event, up to 40% will go~     on to have further neurological injury secondary to stroke (delayed cerebral ischemia) caused~     by constriction of blood vessels (i.e. vasospasm). Previous studies have shown that the~     medication sildenafil, given intravenously, improves vasospasm, but has an associated degree~     of hypotension. The degree of hypotension was well within safety thresholds for these~     patients.~      Sildenafil is a medication that strongly inhibits the protein phosphodiesterase-V (PDE-V).~     The hypothesis for this study is that oral sildenafil will also improve vasospasm, but does~     not result in as much hypotension. Specifically, the investigators look to show that~     comparable doses of oral sildenafil produces the same degree of PDE-V inhibition as an~     intravenous dose while the degree of hypotension is reduced. Additionally, using measurements~     of cerebral blood flow regulation acquired using transcranial Doppler ultrasound, the~     investigators look to show that oral sildenafil produces the same degree of improvement in~     vasospasm and blood flow regulation.~   "
41137|NCT03028285|"~     Unifusol (R) is a solution of arginine sodium succinate for intravenous infusions. Its~     effects include vasodilation, protection of inner layer of blood vessels and improvement of~     blood viscosity. The present phase I study is aimed to evaluate the safety and tolerability~     of Unifusol infusions in healthy volunteers.~   "
41138|NCT03028272|"~     The trial seeks to provide evidence that the Skye ActiveBarrier provides similar surgical and~     functional outcomes as fascia when used for tympanoplasties while offering benefits including~     reduced operative time, better patient satisfaction, and fewer complications.~   "
41139|NCT03028259|"~     A retrospective data review of 243 pregnant women (≤32 wks gestational age), dtat collected~     prior to 5/18/2014, with GDM, or T2DM, and their infants (until discharge from the hospital,~     typically up to 1 week after deliver) will be conducted. These women are of any age and all~     ethnic backgrounds delivering at St. Mary's Health Center.~   "
41140|NCT03028246|"~     The goal of this prospective, non-randomized, single-arm, feasibility study is to develop~     data to evaluate the safety and feasibility of ExAblate 4000 treatment of benign intracranial~     tumors which require clinical intervention in pediatric and young adult subjects.~      Indication of Use: Ablation of benign intracranial tumors in children and young adults which~     are ExAblate accessible.~   "
41141|NCT03028233|"~     The study will test the impact of a community health worker (CHW)-delivered intervention~     aimed at helping families overcome barriers to childhood obesity prevention. Barriers include~     social, environmental, and family issues.~      This intervention will be compared to a control condition consisting of a community health~     worker (CHW)-delivered intervention aimed at helping families improve positive parenting~     skills.~   "
41152|NCT03028090|"~     This study was to gather real-time ECG data through the use of the SHERLOCK 3CG™ Tip~     Confirmation System (TCS), an electrocardiogram (ECG)-based peripherally-inserted central~     catheter (PICC) tip confirmation technology. The study was to promote the development of a~     software package (MODUS) that can accurately define the maximum P-wave on an ECG waveform.~     All study participants received PICCs as their standard of care.~   "
41153|NCT03028077|"~     This study was conducted to investigate the effects of daily supplementation of GS-3K8 or~     GINst15 on acute respiratory illness (ARI) in healthy subjects.~   "
41244|NCT03026868|"~     The novel plate could be used to manage acetabular fractures involving quadrilateral surface~     and posterior column, which may lower the intraoperative blood loss and reduce complication~     rate.~   "
41142|NCT03028220|"~     Good glucose control in type 1 diabetes is associated with a reduced risk of diabetes~     complications and self monitoring of glucose levels is an important component of achieving~     and maintaining glucose control. Continuous glucose monitoring (CGM) improves overall glucose~     control in all age groups when used continuously, and reduces the incidence of low blood~     glucose (hypoglycaemia) in people with good glucose control. Hypoglycaemia is one of the~     commonest metabolic complications of type 1 diabetes and, if it occurs frequently, people can~     become less aware of it. This reduced aware of hypoglycaemia has significant risks including~     seizures, coma and even death, and has an impact on people's ability to drive and function.~      The Abbott Libre intermittent glucose monitoring system provides up to 8 hours of~     retrospective continuous glucose monitoring data to users when the monitor is waved in~     proximity with the sensor. In contrast to realtime CGM the Libre system sensor is used for 14~     days and is non-adjunctive (does not require calibration to capillary blood glucose).~      This clinical study proposes to assess the impact of Libre on frequency, duration and~     severity of hypoglycaemia, compared with the Dexcom G5 realtime CGM and will focus on people~     with impaired awareness of hypoglycaemia.~   "
41143|NCT03028207|"~     Chronic Obstructive Pulmonary Disease (COPD) is a major cause of morbidity and mortality~     worldwide and hence, estimating its prevalence is important. Since 2007, there are few data~     on the prevalence of COPD in the general population in Spain. The main objective of this~     epidemiological observational study is to estimate the prevalence of COPD in residents of~     Spain among the population over 40 years of age. The subjects will be distributed in two~     groups depending on the presence and absence of COPD. The study will have a single visit in~     which a brief interview will take place and subjects will need to complete the medical tests~     the case report form with a series of questionnaires. No drugs will be administered in this~     study.~   "
41144|NCT03028194|"~     Use of Postpartum uterine curettage in reducing hospitalization time or in improving the~     clinical evolution of the patient with preeclampsia/eclampsia.~   "
41145|NCT03028181|"~     The study aims to assess and analyze some selected antioxidants and laboratory parameters~     during hospitalization of the patients with acute pancreatitis. It will allow to better~     understanding of the mechanisms of disease and the development of better diagnostic,~     treatment and monitoring.~      It is an observational diagnostic study and does not involve any additional administration of~     medicinal substances, modification of treatment or dropping the use of routine methods of~     treatment of a disease. The study procedure includes detailed personal medical history as~     separate document like as a routine medical interview, and three times taking a small amount~     of venous blood (together about 15 ml), in the first, third, and seventh day of~     hospitalization (in the case of longer hospital treatment).~   "
41146|NCT03028168|"~     Current therapies for heart failure (HF) bring together strategies to improve quality of life~     and exercise tolerance, as well as to reduce morbidity and mortality. Some HF patients~     present changes in the musculoskeletal system and inspiratory muscle weakness, which may be~     restored by inspiratory muscle training, thus increasing respiratory muscle strength and~     endurance, maximum oxygen consumption (VO2), functional capacity, respiratory responses to~     exercise, and quality of life. Yoga therapies have been shown to improve quality of life,~     inflammatory markers, and VO2 peak in HF patients, mostly with reduced ejection fraction~     (HFrEF). However, the effect of different yoga breathing techniques in patients with HF with~     preserved ejection fraction (HFpEF) has yet to be assessed.~   "
41147|NCT03028155|"~     Colorectal Cancer (CRC) is the third most common cancer and the fourth most common cause of~     cancer-related death worldwide. CRC frequently gives rise to transcoelomic spread of tumor~     cells in the peritoneal cavity, which ultimately leads to Peritoneal Carcinomatosis (PC). A~     new loco-regional treatment modality combines Cytoreductive Surgery (CRS) and Hyperthermic~     Intraperitoneal Peroperative Chemotherapy (HIPEC). The current HIPEC dosing regimens for the~     treatment of colorectal PC can be divided into body surface area (BSA)-based protocols and~     concentration-based protocols. Most groups currently use a drug dose based on calculated BSA~     (mg/m2) in analogy to systemic chemotherapy regimens. These regimens take BSA as a measure~     for the effective contact area, represented as the peritoneal surface in the formula for dose~     intensification. However, an imperfect correlation exists between actual peritoneal surface~     area and calculated BSA. Sex differences, but also altered pathophysiological characteristics~     or frequent complications in patients (ascites) are responsible for differences in peritoneal~     surface areas, which in turn affect absorption characteristics. This takes us away from the~     initial homogenous drug concentration desired, increasing the variability in the systemic and~     tumor exposure to the drug. Pharmacokinetic changes induced by the volume of chemotherapy~     solution with constant drug dose, administered intraperitoneally, have already been reported.~     This resulted in less precise predictions of the toxicity associated with the treatment. By~     contrast, some groups use a totally different dosimetry regimen based on concentration. From~     a pharmacologic point of view, the big advantage of a concentration-based system is that the~     residual tumor nodules after CRS are exposed to a constant diffusional force and, thus,~     cytotoxicity. Unfortunately the prize to be paid for a better prediction of the efficacy of~     the IP chemotherapy is a high unpredictability of the levels of plasmatic cancer chemotherapy~     and, thus, toxicity. This randomised non-blinded phase III clinical trial will be the first~     trial to pharmacologically evaluate the two dosing regimens, BSA-based and~     concentration-based, both applied as standard of care in current practice.~   "
41148|NCT03028142|"~     This is a phase II, randomised, double blind, placebo controlled, complete block, three way~     crossover study to investigate treatment with nebulised RPL554 and tiotropium together in~     patients with moderate to severe chronic obstructive pulmonary disease (COPD). The purpose of~     this study is to assess the bronchodilator effect (opening of the airways) of RPL554 when~     used in combination with a long acting anti-muscarinic receptor antagonist (tiotropium)~     whilst dosing the RPL554 to steady state blood levels. It is planned to randomise up to 30~     patients to have 24 evaluable patients at one study centre. In each treatment period,~     patients will receive an open label dose of tiotropium from a dry power inhaler (DPI)~     followed immediately by a double blind dose of either RPL554 6mg, 1.5mg or placebo (depending~     on treatment sequence) from a nebuliser in the morning on Day 1, Day 2 and Day 3. The dose of~     RPL554 or placebo will be repeated in the evening on Day 1 and Day 2; there will not be an~     evening dose on Day 3.~   "
41149|NCT03028129|"~     The purpose of this study is to determine if the isoniazid is effective in the prevention of~     tuberculosis in a prison population, exposed to the high endemicity of the disease.~   "
41150|NCT03028116|"~     The study is a single centre, phase I, double-blind, randomized, placebo-controlled trial~     that explored the safety and immunogenicity of single dose a allantoic split inactivated~     seasonal influenza vaccine in healthy adults.~   "
41151|NCT03028103|"~     This is a Phase 1, open-label, two-part, safety, PK, and activity study designed to~     characterize the DDI potential of tazemetostat. Tazemetostat will be taken orally BID~     continuously in 28-day cycles in both study parts.~   "
41154|NCT03028064|"~     Acute upper gastrointestinal bleeding (AUGIB) is a common medical emergency. In an ageing~     population, antiplatelet drugs are increasingly being prescribed for treatment and~     prophylaxis against cardiovascular thrombo-embolic events. In many patients, platelet~     dysfunction mostly acquired is the principal cause of bleeding. To clinicians, the management~     of patients on antiplatelet drugs or anticoagulants is a challenge. One has to carefully~     balance the bleeding against thrombo-embolic risks. Therefore measuring platelet function~     should be integral in the management plan. A quantitative measurement allows titration of~     platelet function in accordance with bleeding or thromboembolic risk. Platelet function has~     not been studied in a large cohort of patients with acute upper gastrointestinal bleeding. As~     a first step, the study will determine if platelet dysfunction is associated with clinical~     outcome. In this prospective, observational single centre cohort study of consecutive~     patients with overt signs of acute upper gastrointestinal bleeding, their platelet function~     by point of care tests (light transmittance aggregometry, verify now p2y12,the platelet~     function analysis system (PFA-100) upon their admissions. Patients will be followed up for 30~     days after trial enrollment. The primary endpoint is defined as significant bleeding that~     requires interventions (endoscopic, radiologic or surgery). Secondary end points include~     cardio- and cerebrovascular thrombo-embolic events and all cause deaths. A receiver operating~     characteristic (ROC) curve analysis is calculated for each point-of-care test to evaluate if~     individual test can distinguish between patients with and without primary end point. This~     study aims to evaluate the capability of platelet function tests to predict clinical outcome~     in patients with AUGIB. Logistic regression models will then be built in search for~     independent correlates to the primary and secondary endpoints and to adjust for confounding~     variables.~   "
41155|NCT03028051|"~     Chronic pain, life style factors and quality of life (KROKIETA) is a multicenter study that~     aims to analyze life style factors, socioeconomic and psychometric properties, metabolic~     problems, drug use, quality of life and biochemical variables in chronic non-cancer pain~     patients. The life style factors will be compared to those of normal population. At baseline,~     the study patients fill in questionnaires (A-E), the patients´ weight, length, waist and~     blood pressure are measured, pain-related factors are recorded and blood samples taken.~     Changes in the quality of life of the study patients will be evaluated by questionnaires~     during follow-up at 2 years and 5 years.~   "
41156|NCT03028038|"~     The purpose of this study is to determine if the injection of Platelet-rich plasma (PRP) is~     effective in reducing alveolar bone loss that happens after each rapid maxillary expansion~     (RME) on the buccal aspect of the posterior teeth.~      16 patients with a skeletal maxillary constriction aged between 10-16 years old will get into~     orthodontic treatment to widen the maxilla using Hyrax appliance.~      An amount of patient blood will be withdrawn and centrifuged to get PRP. Then the PRP will be~     injected in one half of each patient mouth in a split-mouth design, beneath the buccal~     periosteal of the first molars and first premolars, the halves will be chosen randomly.~      High resolution CBCT images will be taken before and after orthodontic treatment to analyze~     buccal bone thickness and height changes.~   "
41157|NCT03028025|"~     The primary objectives of this study are to evaluate the performance of StatSeal Advanced~     used in conjunction with the TR Band (SSA) as compared to the TR Band without SSA (TRB)~     relative to: the incidence of peri-procedural radial artery occlusion (RAO) at discharge or~     24 hours, whichever occurs first, and the Time to Hemostasis (TTH).~   "
41158|NCT03028012|"~     Hypothesis~      The main hypothesis of this study is that anti-inflammatory medications (ketorolac or~     dexamethasone) will provide longer-lasting and greater pain relief than just lidocaine in~     trigger point injections where a local twitch response is evoked at the time of the~     injection.~      Purpose/Specific Aims~      The primary objective of this study is to compare the efficacy of three substances used in~     TPIs with a LTR identified at the time of the injection: a CS (dexamethasone), a NSAID~     (ketorolac), or only a local anesthetic (lidocaine).~   "
41159|NCT03027999|"~     Rheumatoid arthritis (RA) is a progressive disease that affects mainly small and medium~     joints and, in the absence of appropriate background therapy, leads to progressive joint~     destruction, functional, psychological, social and occupational repercussions.~      Several biomedicine treat this pathology, including rituximab (RTX). It is recommended to~     evaluate the therapeutic response to RTX and re-administer it from the 24th week when the~     goal of remission has not been achieved. However, the optimal modality for reprocessing~     remains to be determined.~      To this end, different approaches have been explored, such as lymphocyte typing or ultrasound~     monitoring. The pace of these examinations, however, remains wide and their cost is not~     negligible. This is why we propose here to explore the track of a tight follow-up nurse~     DAS28.~      The hypothesis is that a tight nursing follow-up can detect the symptomatic recovery earlier~     than the current medical follow-up.~      The hypothesis is that a tight nursing follow-up can detect the symptomatic recovery earlier~     than the current medical follow-up~   "
41160|NCT03027986|"~     Urinary incontinence (UI) is defined by the International Continence Society as any~     involuntary loss of urine complained by the patient. The anatomical and histological~     specificities of the pelvic floor muscles (PFM) give them a key role in the control of~     urination but also in the control of postural stability. These activities are involuntary~     automatisms and the mechanisms that lead to post-prostatectomy stress urinary incontinence~     are not only due to the loss of voluntary contraction of the pelvic floor muscles. The~     mechanisms that lead to UI are more complex and may involve the loss of efficacy of all deep~     muscle stabilizing lumbo-pelvic region. Rehabilitation of pelvic floor muscles is recommended~     in the treatment of urinary incontinence after prostatectomy (Grade A), but there is a lack~     of evidence to define the best treatment regimen for PFM rehabilitation.~      Two kinds of PFM rehabilitation are are commonly practiced by specialized physiotherapists.~        -  The first one is made in individual box, in supine position. By analytic contractions of~          the PFM, (exercises of Kegel type) +/- associated with an instrumental biofeedback. This~          method used voluntary contractions of MPP.~        -  The second is realized in various positions following a gravity progression, in~          individual and /or common room. This technique aims to restore a stabilization of the~          entire lumbo-pelvic region by postural recruitment involving synergistic contractions of~          the PFM.~      These trials propose to compare these two rehabilitation programs on populations with~     postoperative follow-up of more than 12 months.~      We chose to objectify the urine leaks with the pad test (weighing of the protections urinary~     over a period of 3 times 24h) which will be our main evaluation criterion. The home test pad~     of 3 times in 24 hours has been used by numerous studies and its reproducibility and~     reliability are established.~      Urinary incontinence is a recognized factor of sedentary lifestyle, fatigue, impaired mental~     health and decreased of physical fitness. We therefore wish to observe these parameters for~     each of our two randomized groups~   "
41161|NCT03027973|"~     This study compares two treatments for the management of heavy menstrual bleeding, ulipristal~     acetate (UPA) and tranexamic acid (TEA), on health-related quality of life. Half of the~     participants will receive UPA and a placebo, and the other half will receive TEA and a~     placebo.~   "
41162|NCT03027960|"~     The investigators propose a small pilot proof of concept study to not only prove the~     existence of, but also probe the mechanisms underlying cardio-renal effects of empagliflozin~     in patients with heart failure. The investigators propose a 50 patient randomized,~     double-blind, placebo-controlled crossover study with patients with stable HF, type II~     diabetes and an eGFR >45ml/min/1.73 m2 who are chronically receiving loop diuretics.~   "
41163|NCT03027947|"~     The goals of this study are to provide sensory information to amputees and reduce phantom~     limb pain via electrical stimulation of the lumbar spinal cord and spinal nerves. The spinal~     nerves convey sensory information from peripheral nerves to higher order centers in the~     brain. These structures still remain intact after amputation and electrical stimulation of~     the dorsal spinal nerves in individuals with intact limbs and amputees has been demonstrated~     to generate paresthetic sensory percepts referred to portions of the distal limb. Further,~     there is recent evidence that careful modulation of stimulation parameters can convert~     paresthetic sensations to more naturalistic ones when stimulating peripheral nerves in~     amputees. However, it is currently unclear whether it is possible to achieve this same~     conversion when stimulating the spinal nerves, and if those naturalistic sensations can have~     positive effects on phantom limb pain. As a first step towards those goals, in this study,~     the investigators will quantify the sensations generated by electrical stimulation of the~     spinal nerves, study the relationship between stimulation parameters and the quality of those~     sensations, measure changes in control of a prosthesis with sensory stimulation, and quantify~     the effects of that stimulation on the perception of the phantom limb and any associated~     pain.~   "
41164|NCT03027934|"~     The overall objective of this study is to assess P2Y12 inhibition ex vivo in blood samples~     obtained from diabetic subjects who will be administered one of the two P2Y12 antagonists in~     a cross-over design.~   "
41165|NCT03027921|"~     The diagnosis of liver fibrosis lesions remains an important issue in patients with chronic~     liver diseases. The early detection of fibrosis is important for determining disease~     progression and postponing the evolution of chronic hepatitis into cirrhosis via the~     implementation of prompt and specific treatment. However, as chronic liver disease can remain~     asymptomatic for a long time, numerous cirrhotic patients are diagnosed belatedly, when~     life-threatening complications start appearing.~      Noninvasive methods for liver fibrosis diagnosis have been developed over the last decade. In~     this setting, blood fibrosis tests and transient elastography have been shown to be accurate,~     and are now commonly used as first-intention tests for liver fibrosis diagnosis in chronic~     liver diseases. However, these tests are usually performed by a hepatologist to whom the~     patient has been referred following the appearance of symptoms suggestive of chronic liver~     disease. Thus the number of patient diagnosed early by these new tools, that is in the period~     before symptoms start appearing and during which preventative measures may be particularly~     beneficial, remains quite low in relation to the prevalence of the disease. This prevalence~     has been estimated to 0.5 to 2.8 % in general population.~      Many studies have identified the value of hemodynamic and morphological ultrasound parameter~     in providing information on liver fibrosis degree. Moreover, abdominal ultrasound is widely~     used for various symptoms, and thus could be an excellent way to detect patients with signs~     evoking liver fibrosis or cirrhosis, who could then be referred to a liver specialist for~     confirmation of the diagnosis by blood fibrosis tests and/or transient elastography. To be~     feasible during a nonspecific US examination, and by any radiologist, these signs should be~     easy and quick to collect. Addition of a quick measure of hepatic stiffness could increase~     the screening interest of ultrasound examination.~      The main aim of the present study was thus to validate 3 simple US signs in patients referred~     for ultrasound abdominal examination for reasons other than suspicion of liver disease.~   "
41166|NCT03027908|"~     This study is a double-blind, randomised, parallel group efficacy study. A minimum of 240~     healthy female and male participants aged over 18 years will participate. The participants~     will be randomised into two groups. Participants will be randomly assigned to the test groups~     according the allocation table prepared by the Statistician.~      Participants will be enrolled on to the study according to the inclusion/exclusion criteria.~     After enrollment participants will have their teeth cleaned using a professional prophylaxis~     polish by the study hygienist. The participants will then be provided with a standard~     cosmetic silica fluoride toothpaste and a toothbrush to use at home, twice a day for up to~     four weeks. After this time, they will return to the test site and have the baseline dental~     assessments. Participants will then be randomly allocated to one of the two test products~     which they will use at home, twice a day for the duration of the study. Dental assessments~     will be conducted after 13 and 26 weeks of product use at the study site.~   "
41167|NCT03027895|"~     The purpose of this study is to compare the effect of lumen-apposing metal stent (LAMS) and~     double pigtail plastic stents (DPPSs) on the drainage of pancreatic walled-off necrosis~     (WON), mainly to observe the efficacy and safety of LAMS for WON.~   "
41168|NCT03027882|"~     The purpose of this study is to examine the inter/intra rater reliability as well as the~     validity of the Swing Test in asymptomatic adults . In addition, this study will examine if~     there are musculoskeletal predictors to the movement quality of the swing test.~      The Swing Test is a movement test used by physical therapists to identify movement problems~     during a simulated running stride~   "
41169|NCT03027869|"~     Healthy volunteers will be recruited. All subjects will be tested a battery of~     neuropsychological tests, then undergo fluorodeoxyglucose-positron emission tomography (PET)~     and magnetic resonance imaging (MRI). During the PET and MRI, they will be stimulated with~     transcranial direct current stimulation (tDCS) for 15 minutes. Half of subjects will receive~     real tDCS and the other half will receive sham tDCS.~   "
41170|NCT03027856|"~     The purpose of this study is to investigate the feasibility and safety of the Magmaris BRS~     for treatment of coronary bifurcation lesions.~   "
41171|NCT03027843|"~     Assisted reproduction treatment in patients with low ovarian reserve is a big difficult~     clinical problem. Growth hormone (GH) is crucial in the development of follicles since~     preantral follicle to ovulation and can promote steroid hormones and gamete formation,~     increase the granular cell sensitivity,and inhibition of follicular atresia. Latest research~     shows that GH can improve egg quality through regulating mitochondrial function of the~     oocytes and increase the rate of embryo euploid. It becomes a new argument in that promotion~     of clinical pregnancy rate in assisted reproduction treatment. GH applied in the field of~     assisted reproduction 30 years experience of applicable people, but drug dosage, drug~     intervention time continue to explore. 2015 China assisted reproductive stimulate ovulation~     medicine expert consensus recommend joint GH for poor ovarian response, repeated implantation~     failure patients and older patients assisted fertility treatment, but not on the specific use~     time limit, the daily dose of drugs and curative effect. How to maximize growth hormone~     potential advantage in improving the egg quality bothers the clinical doctors. We had a~     self-controlled retrospective analyses in growth hormone application and found that the~     average daily injections of GH dose 2 iu for 45 days can significantly improve the embryo~     quality in patients with low ovarian reaction. And now long-acting recombinant human growth~     hormone is available, which make it convenient for patients. A forward-looking experimental~     is expected to answer clinical practical problems and provide proper GH regimen for low~     ovarian responder.~   "
41172|NCT03027830|"~     Even in the era of drug-eluting stents, bifurcation lesions remain one of the most~     challenging lesion subsets in coronary intervention practice. This study was performed to~     evaluate the functional outcomes of pressure wires (IFR)-guided jailed side-branch~     intervention strategy.~   "
41173|NCT03027817|"~     Positioning a patient in prone position under anaesthesia significantly alters cardiovascular~     physiology. Cervical myelopathy patients are known to have autonomic dysfunction. Such~     patients when positioned in prone position under anaesthesia carry a higher risk of~     developing hemodynamic changes and this can compromise spinal cord perfusion.~      This prospective observational study was conducted on 30 patients with cervical myelopathy~     who underwent surgery in prone position at NIMHANS, Bangalore hospital. The non invasive~     cardiac output monitor (NICOM, Cheetah Medicals) was used to record various hemodynamic~     parameters. The hemodynamic parameters were recorded at baseline, post induction, post~     intubation, prior to prone position, post prone position, and every five minutes thereafter~     upto 20mins.~      The hemodynamic parameters that were recorded using the NICOM monitor:~        -  HR - Heart rate (beats /min)~        -  NIBP - non invasive blood pressure (mmHg)~        -  MAP - mean arterial pressure(mmHg)~        -  CO - cardiac output (l/min)~        -  CI - cardiac index (l/min/m2)~        -  SV - Stroke volume (ml/beat)~        -  SVV -stroke volume variability (%)~        -  TPR - total peripheral resistance (dynes. sec/cm5)~   "
41174|NCT03027804|"~     A large multicentric registry to obtain data to analyse the pulmonary autograft (PA) failure~     phenomenon and feed more complex biomechanical models to be integrated with clinical imaging~     with the final aim to predict Ross operation's outcomes and define strategies to ameliorate~     its results.~   "
41175|NCT03027791|"~     Subjects will participate in a 12-week church-based intervention with five separate~     components: 1) participation in weekly group sessions; 2) daily use of Fitbit activity~     tracker; 3) daily, twice a day blood pressure monitoring; 4) daily online food tracking; and~     5) daily use of VR at home (starting at week 6). Participants will also receive phone~     contacts from nurse coaches (twice a week during the first 4 weeks, then once a week for the~     remaining 8 weeks), who will answer questions and provide support.~   "
41176|NCT03027778|"~     The purpose of this pilot study is to evaluate 1) the effect of intradialytic pedaling~     exercise on arterial stiffness and other arterial hemodynamic parameters over 4 months, and~     2) the longer-term effect of pedaling on arterial stiffness and other arterial hemodynamic~     parameters 4 months after finishing the exercise intervention (8 months after study~     initiation).~      The investigators also aim to examine the impact of intradialytic pedaling exercise on~     general health, anthropometric measures, physical function, and routine laboratory blood~     markers as secondary outcome measures, as well as to assess feasibility, safety and adverse~     events associated with the intradialytic pedalling exercise.~      Recruitment of more participants in the future will be considered if warranted.~   "
41177|NCT03027765|"~     The purpose of the study is~        -  To determine the Prevalence of constructed space maintainers at Pediatric Dentistry and~          Dental Public Health Department, Faculty of Oral and Dental Medicine, Cairo University.~        -  To assess the knowledge, attitude and awareness of constructed space maintainers for~          pediatric patients' guardians at Pediatric Dentistry and Dental Public Health~          Department, Faculty of Oral and Dental Medicine, Cairo University.~      and~      - To assess the knowledge, attitude and practice of pediatric dentists towards use of space~     maintainers in children, at Pediatric Dentistry and Dental Public Health Department, Faculty~     of Oral and Dental Medicine, Cairo University.~   "
41178|NCT03027752|"~     Comparison of two methods for revascularization of the bifurcation of common carotid artery:~     carotid endarterectomy with longitudinal incision carotid endarterectomy patch angioplasty~     compared with new technique of carotid endarterectomy with autoarterial remodeling of~     bifurcation of the common carotid artery~   "
41179|NCT03027739|"~     CART-19 cells has emerged as a powerful targeted immunotherapy, showing striking responses in~     highly refractory CD19+ acute lymphoblastic leukemia (ALL). This study aims to assess the~     safety and toxicity of CART-19 cells to patients who are refractory or at highest risk of~     relapse as defined by MRD+ status.~   "
41180|NCT03027726|"~     Background: The global pandemic obesity has led to increased risk for prediabetes and type 2~     diabetes (T2D).~      Objectives: (i) To evaluate the effect of a 22 weeks multidisciplinary intervention program~     including exercise on T2D risk in pre-adolescents with high risk to develop T2D, and (ii) To~     identify the profile of microRNA in circulating exosomes and in blood peripheral mononuclear~     cells in pre-adolescents with high risk to develop T2D and its response to a~     multidisciplinary intervention program including exercise.~   "
41181|NCT03027713|"~     The purpose of this study is to describe the diaphragm electromyographic activity (Edi) in~     healthy lung patients due to obtain a reference to guide the weaning in those patients~   "
41182|NCT03027700|"~     The goal of this study is to learn more about liver fibrosis and methods to detect it. We~     will evaluate and compare multiple MRI based measures of liver fibrosis in subjects with and~     without liver disease.~   "
41183|NCT03027687|"~     Bilateral (left cathodal/ right anodal) transcranial Direct Current Stimulation (tDCS) over~     the dorsolateral prefrontal cortex (DLPFC) seems to reduce craving and to increase the time~     till smoking the first cigarette after the intervention. More interesting however, is to~     study whether actual cigarette consumption decreases after repetitive tDCS. The current study~     will explore this by means of EMA in a large sample of 60 smokers. Participants will receive~     twice daily sessions of real tDCS or sham for three days in one week. Furthermore,~     electrophysiological responses (ERPs) will be measured at baseline, one day after the last~     tDCS session and at three months follow up to study the working mechanism behind the effects~     of tDCS.~   "
41184|NCT03027674|"~     Objective: To compare the efficacy of topical 10% nifedipine versus 5% sildenafil in patients~     with secondary Raynaud's phenomenon (RP).~      Methods: A randomized, double-blind, placebo-controlled pilot study took place in 10 patients~     with secondary RP. Topical 10% nifedipine on one hand and 5% sildenafil on the other hand~     were applied. The thumbs didn't receive any cream and served as a control group. The primary~     outcome was the improvement of blood flow and vessel diameter of the digital arteries~     measured by high frequency color Doppler ultrasound before and 1 hour after treatment.~   "
41240|NCT03026920|"~     It was reported that satisfactory postoperative outcome was difficult to obtain for the~     pelvic or acetabular fracture in old people. The less invasive surgical method was conducted~     in this study. Then, the clinical results were compared with the patients treated using~     traditional methods to assess the less invasive method.~   "
41241|NCT03026907|"~     The purpose of this study is to compare the efficacy of alitretinoin and azathioprine in the~     treatment of patients with severe chronic non-hyperkeratotic hand eczema.~   "
41185|NCT03027661|"~     This is a prospective randomized controlled trial in which patients that are scheduled to~     undergo a laparoscopic hysterectomy would be allocated to one of two groups: Paracervical~     block with local anesthetic (bupivacaine 0.5%), or placebo. This would be achieved using~     block randomization. The intervention would be performed after the patient is under general~     anesthesia, prior to starting the surgery. Patients would be consented in the office or~     preoperative area (before receiving sedatives). As far as the intervention itself, it would~     consist of injecting 5 mL of 0.5% bupivacaine into the cervical stroma at 3 and 9 o'clock,~     which is standard technique for para-cervical block. The remainder of the procedure will then~     continue in a regular fashion. Alternatively, patients in the control group will be injected~     with 5 mL of normal saline. The surgeon would be blinded as to patient allocation. Research~     staff will have previously prepared the formulations (saline or bupivacaine) and have sent~     them to the operating room prior to beginning the procedure depending on assigned group. At~     the end of the case, pain will be assessed using a visual analogue scale with a range from 0~     to 10 by one of the researches who will also be blinded to the group. This will be done at 30~     and 60 minutes after surgical stop time. Additional pain control in the postanesthesia care~     unit (PACU) will be standardized to all patients.~      Hypothesis:~      Performing a para-cervical block with local anesthetic prior to a laparoscopic hysterectomy~     significantly reduces pain after the procedure~   "
41186|NCT03027648|"~     Objective: To investigate the effects of levonorgestrel-releasing intrauterine system~     (LNG-IUS) for symptomatic adenomyosis.~      Methods: From December, 2006 to December, 2014, symptomatic patients of adenomyosis diagnosed~     (with dysmenorrhea and/or menorrhea) by transvaginal ultrasound in outpatient or inpatient~     clinics of Peking Union Medical College Hospital were given the treatment of LNG-IUS. Before~     and after placement of LNG-IUS, during each following period, all the parameters were~     recorded prospectively, including carrying status of IUS, symptoms and scores of~     dysmenorrhea, menstruation scores, biochemical indicators, physical parameters, menstruation~     patterns and adverse effects.~      Primary outcome measures: symptoms and scores of dysmenorrhea and menorrhea~      Second outcome measures: carrying status of IUS~   "
41187|NCT03027635|"~     Insertion of a tunnelated peritoneal catheter (PleurX) allows repeated intermittent small~     volume fluid drainage at home. The treatment may improve the management of ascites and have a~     beneficial effect on the quality of life.~      This study aims to evaluate the beneficial and harmful effects of the peritoneal catheter~     (PleurX) versus repeated large volume paracentesis for patients with cirrhosis and diuretic~     resistant ascites.~      The trial is an investigator initiated, randomised, single blind, parallel arm, controlled~     trial.~      Tunnelated peritoneal (PleurX) catheter versus large volume paracentesis. All patients will~     receive ciprofloxacin to prevent spontaneous bacterial peritonitis.~      We will include 32 adult patients with cirrhosis Duration of trial 18 months. The total~     duration of follow up is six months. The primary outcome is paracentesis free survival.~   "
41188|NCT03027622|"~     The complications that could occur during or after the extraction of the mandibular third~     molar teeth with pericoronitis affect patient's life quality considerably. Various scales are~     used to reveal how much the life quality of patients is affected this treatment. The aim of~     this study is to identify the long term life quality of patients through the OHIP-14 TR scale~     without removing the mandibular third molar teeth with mild pericoronitis.~   "
41189|NCT03027609|"~     Prospective, double-blind, randomized assessment of the efficacy, safety and pharmacokinetic~     of Aerucin® as adjunct treatment (in addition to standard of care antibiotics) for pneumonia~     caused by P. aeruginosa.~   "
41190|NCT03027596|"~     Burned skin areas, which were initially vital, can be irreversibly damaged by wound~     progression. The aim of the present study is to evaluate the feasibility of ischemic~     conditioning to reduce secondary wound progression.~   "
41191|NCT03027583|"~     This trial is a single-site, randomised, double blind, placebo-controlled, two-armed~     parallel-group trial in healthy adult volunteers. The trial will investigate the effect of~     oral supplementation of a probiotic strain on the ability to attenuate exercise-induced~     deterioration of intestinal barrier function and gastrointestinal symptoms.~   "
41192|NCT03027570|"~     80 children aged 5-13, BMI≥85%, will be recruited to a program for the treatment of~     overweight children.The intervention group will use the app Just Dance Now and The control~     group will be exposed to the usual program without the app. Measurements will be performed at~     the beginning of the program, the end and 3 months after completion of the intervention.~   "
41193|NCT03027557|"~     The only known cure for primary hyperparathyroidism is surgical removal of one or more~     parathyroid glands. Some patients however, do not fulfill criteria for surgery or do not want~     to undergo a procedure due to fear of the associated risks. Therefore a medical alternative~     is warranted.~      This study aims to evaluate the effects of Denosumab alone, and in combination with~     Cinacalcet, as a medical treatment for patients suffering from primary hyperparathyroidism,~     with mild osteoporosis. To the best of our knowledge no previously reported randomized~     controlled trial has investigated the use of denosumab in primary hyperparathyroidism.~      60 patients will be enrolled in three different treatment-groups: 20 receiving both Denosumab~     and Cinacalcet, 20 Denosumab and placebo and 20 placebo and placebo. Patients included do not~     meet the criteria for, or have no wish for a surgical procedure.~      By combining the two drugs, this study could possibly contribute to the discovery of a~     realistic medical alternative to surgery. It is expected that the therapy will be able to~     both control s-calcium and s-intact parathyroid hormone (iPTH), and simultaneously enhance~     bone-structure. The therapy thus has the potential of preventing fractures and possibly other~     long-term effects of primary hyperparathyroidism such as formation of kidney stones, and~     coronary calcification. Another objective of this project is to investigate whether the~     combined therapy can facilitate an actual reset of the Calcium-sensing receptor, and thereby~     de facto cure the disease.~   "
41194|NCT03027544|"~     This clinical trial was designed to investigate the efficiency and toxicity of tomotherapy~     for refractory brain metastases.~   "
41195|NCT03027531|"~     This study is a randomized controlled trial to test acceptability, feasibility and~     preliminary efficacy of an interactive computer-based intervention with individualized~     feedback to promote sexual health in adolescents and young adults with assessment of~     behavioral and biomarker outcomes.~   "
41196|NCT03027518|"~     The purpose of this study is to explore the efficacy and feasibility of an integrated,~     prescriptive, and trackable wellness intervention combining five wellness elements including~     exercise, mindfulness, sleep, social connectedness, and nutrition in Beloit College students.~     This program is called WILD 5 Wellness: A 30-Day Intervention. Results for this study will~     be quantified through the use of standardized self-report questionnaires administered prior~     to and after students complete the WILD 5 program (Group 1) or 30 days of inactive~     participation (Group 2), and again approximately 30 days later when the initially inactive~     group (Group 2) will have just completed their active participation in the WILD 5 program and~     the first WILD 5 group (Group 1) will be approximately 30 days out from completion of their~     WILD 5 active portion. Data will be collected to evaluate participants' adherence and~     response to each element of WILD 5, a 5-pronged 30-day wellness intervention. It is expected~     that this 30-day integrated, prescriptive, and trackable program will be found to be an~     efficacious wellness intervention for Beloit College students as compared to the control~     (inactive) group of students not participating in the Active program.~   "
41197|NCT03027505|"~     MUAC only is a non-inferiority trial with external control carried out between January 2017~     and December 2017 in the Yako district (northern region), Burkina Faso.~      The objective of this study is to evaluate an integrated protocol for acute malnourished~     children without medical complication. The hypotheses of the integrated protocol include :~        1. A global treatment of acute malnutrition (moderate and severe) with a single treatment~          (RUTF) would improve the functioning of the program through early identification of~          acutely malnourished children, while achieving a better coverage and using a single~          supply chain.~        2. A gradual reduction of RUTF dosage according to a child's MUAC status could~          significantly increase the number of children on treatment without increasing overall~          RUTF quantity while maintaining similar recovery rates.~   "
41198|NCT03027492|"~     In the last few years, a new clinical entity has emerged which includes patients who consider~     themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though~     they do not have celiac disease (CD) or wheat allergy. This clinical condition has been named~     non-celiac gluten sensitivity (NCGS), although in a recent article, the investigators~     suggested the term non-celiac wheat sensitivity (NCWS), because it is not known to date~     what component of wheat actually causes the symptoms. The clinical picture of NCWS is~     characterized by combined gastrointestinal (bloating, abdominal pain, diarrhea and/or~     constipation, nausea, epigastric pain, gastroesophageal reflux, aphthous stomatitis) and very~     different extra-intestinal and systemic manifestations (headache, depression, anxiety, 'foggy~     mind,' tiredness, dermatitis or skin rash, fibromyalgia-like joint/muscle pain, leg or arm~     numbness, and anemia). Nowadays, there no data about a possible relationship between~     gynaecological disorders and food ingestion and food allergy/intolerance. Therefore, the aims~     of the present study are to investigate 1) the prevalence and characteristics of~     gynaecological disorders in NCWS patients compared to CD and irritable bowel syndrome (IBS)~     controls, and 2) the modification of such disorders in NCWS patients after a gluten~     (wheat)-free diet.~   "
41199|NCT03027479|"~     the aim is to study skeletal muscle metabolism alterations métaboliques associated with~     weight loss in women with ovarian and/or endometrial cancer according to BMI.~   "
41200|NCT03027466|"~     Background:~      Quitting smoking is hard. It is easy to relapse. Smokers may think of temptation to smoke as~     a threat if they think it suggests that they are unable to meet the challenges of stopping.~     When people feel such a threat to their sense of self-identity, they may get defensive. They~     may want to downplay the importance of quitting. This could make them try to quit less.~     Self-affirmation is a process of focusing on strengths and values. This can offset threats to~     the self and promote healthier behavior.~      Objective:~      To explore people s values, smoking attitudes, and smoking behavior.~      Eligibility:~      People ages 18 and older who smoke~      Design:~      The study takes place entirely on a mobile device.~      Participants will give their age, gender, data about their smoking habits, and desired quit~     date.~      Then they will get different texts about quitting.~      Participants will answer follow-up surveys 1 and 3 months later.~   "
41201|NCT03027453|"~     The B-SPATIAL-Registry will provide a tool of quality assessment for stroke specific~     Treatments such as endovascular treatment. It will also enable the participating hospitals to~     compare the quality of care of their facility. At the same time, B-SPATIAL will provide an~     opportunity of scientific evaluation of new therapeutic procedures or specific treatments in~     stroke (i.e. reversal of oral anticoagulation in intracerebral hemorrhage or intravenous~     thrombolysis), not sufficiently investigated so far. Finally, the B-SPATIAL Registry will~     allow for an identification of key quality indicators that assure valid quality assessment~     aiming at a reduced documentation load for future quality management.~   "
41202|NCT03027440|"~     Background:~      Suicide rates are rising. In 2013, it was the third leading cause of death in children ages~     10-14. It was the second leading cause of death for ages 15-24. Many risk factors for suicide~     have been found. But it is hard to predict. Evidence is growing that some factors that may~     make people vulnerable to suicide can be identified before birth or in early childhood.~     Researchers want to study vulnerability to suicide. They want to look at different kinds of~     development. These include prenatal, social, behavioral, cognitive, and neurologic. They will~     do this by linking data from the United States Collaborate Perinatal Project (CPP) to the~     National Death Index (NDI). The CPP data are from about 50,000 children born to mothers who~     enrolled in the 1960s. The CPP observed and examined about 60,000 pregnancies. Then it~     followed the babies from when they were born through age 7. The CPP collected data on things~     like family and medical history, economic status, and behavior. The NDI has data on the date~     and cause of death.~      Objective:~      To link data from the CPP to the NDI in order to study certain precursors to suicide.~      Eligibility:~      Children born to women who enrolled in the CPP in 1959 1966 and known to be alive at age 7~      Design:~      Data on children from the CPP will be submitted electronically to the NDI. It will be~     encrypted and data from the NDI will be deidentified to protect confidentiality. It will then~     be merged with existing CPP data. Researchers will analyze the data.~   "
41242|NCT03026894|"~     To investigate the residual ridge resorption at anterior and posterior maxillary and~     posterior mandibular ridges among conventional complete dentures and implant overdenture~     wearers, and determine its association with the relative occlusal forces distribution,~     treatment groups and other patient variables.~   "
41203|NCT03027427|"~     Background:~      Certain stomach cancers are rare, but they have high mortality rates. Researchers want to~     learn more about gastric (stomach) tumors. In this study, they want to collect data from~     people who have stomach cancer or are at risk to get it. This data will be used to see if the~     people can be in other studies.~      Objective:~      To study tissue from stomach tumors and find people eligible for more studies on gastric~     cancer.~      Eligibility:~      Adults at least 18 years old who have or may have stomach cancer, lesions that may be related~     to stomach cancer, or an inherited disorder that leads to stomach cancer.~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Blood and urine tests~      Heart tests~      Scans or ultrasound.~      For the scans, participants lie in a machine that takes pictures. For some scans, they will~     swallow or be injected with a small amount of radioactive material. Special cameras will show~     the material in the body.~      Tumor sample taken with a needle or surgery~      Some participants will have an endoscopy. A long, flexible tube with a camera will be~     inserted through the mouth into the stomach. The tube will collect tissue from the stomach.~      Some participants may have follow-up visits. Some may be invited to join other studies.~     Others will be contacted by phone to see how they are doing.~   "
41204|NCT03027414|"~     Background:~      Researchers want to better understand brain processes related to fear and anxiety. They want~     to find out if transcranial magnetic stimulation (TMS), a type of brain stimulation, can~     reduce anxiety.~      Objective:~      To see how TMS affects fear and anxiety through memory and attention tasks.~      Eligibility:~      Healthy people ages 18-50 who are right-handed~      Design:~      Participants will be screened through another protocol.~      Participants in the pilot study will have 1 visit. This includes:~      Urine tests~      Questionnaires about mood and thinking~      Shock and startle workup: Electrodes are taped to the wrists or fingers. Participants will be~     shocked to find out what level of shock is uncomfortable but tolerable. They will hear loud,~     sudden noises through headphones.~      TMS: A coil is held on the scalp. A magnetic field stimulates the brain. Sometimes they might~     receive fake TMS. This feels the same as real TMS. They will perform simple tasks.~     Participants in the main study will have 2 visits within 2 weeks.~      The first visit includes:~      Urine tests~      Questionnaires about mood and thinking~      MRI: Participants lie on a table that slides into a scanner. They will be in the scanner~     about 1 hour. A computer screen in the scanner will tell them to perform simple tasks.~      The second visit includes:~      Shock and startle workup~      TMS~   "
41205|NCT03027401|"~     Background:~      Saliva, blood, tissue, and cancer contain DNA. DNA makes the instruction book for the cells~     in the body. Cancer is caused by changes in DNA that affect cell function. Researchers want~     to test DNA of people with tumors. They want to look for genetic changes in tumors that could~     be targets for treatment. Because DNA can change as cancer changes, more testing may be done~     at different times.~      Objectives:~      To find the DNA changes in cancer that may help guide treatment. To collect samples and data~     to be used in future studies.~      Eligibility:~      People any age with cancer or a pre-cancerous tumor~      Design:~        -  Participants will be screened with a medical history, physical exam, and blood tests.~          Participants will give a sample of their tumor. This is usually from a previous~          procedure. Participants will give a saliva or blood sample. They cannot eat, drink,~          smoke, or chew gum for 30 minutes before giving saliva. They will spit about 1 teaspoon~          of saliva into a tube.~        -  Some participants may have a punch biopsy instead. A small instrument will take a small~          piece of skin.~        -  Researchers will collect data from participants medical records.~        -  Participants will answer questions about their family health history. They will also~          answer questions about their views on the study, including possible unexpected results.~        -  Extra blood or tissue samples may be taken at other times during the participants'~          treatment. All samples will be saved in secure ClinOmics freezers to be used in future~          studies.~        -  Participants will be told by their doctors if any test results affect their health or~          their cancer treatment.~   "
41206|NCT03027388|"~     Background:~      The brain is separated from the rest of the blood stream by the blood-brain barrier. This is~     like a filter that protects the brain. But is also a challenge when medicines need to get~     into the brain. Researchers want to give the new drug LB100 to people before brain tumor~     surgery. They will measure how much LB100 is in the blood and how much gets into the brain.~     This may help with the use of LB100 to treat brain tumors in the future.~      Objective:~      To see if LB100 can pass into the brain.~      Eligibility:~      People at least 18 years old with a brain tumor that requires surgery~      Design:~      Participants will be screened with:~      Physical exam~      Medical history~      Blood tests~      Neurosurgery evaluation~      Scans~      Heart tests~      Tumor sample. This can be from a previous procedure.~      Participants will have their brain surgery at the Clinical Center.~      Participants will get a dose of the study drug through a plastic tube in a vein for 2 hours~     during surgery.~      Participants will have blood taken 7 times in the 8 hours after getting the study drug.~      Tumor samples will be taken during surgery.~      Participants will have a heart test after getting the study drug. Sticky pads on the skin~     will measure electrical activity of the heart.~      Two weeks after leaving the hospital, participants will have a follow-up visit. They will~     have a physical exam and blood tests.~      One month after surgery, they will be contacted in person or by phone to see how they are~     doing.~   "
41207|NCT03027375|"~     This trial will assess the efficacy and safety of QSG in CHF.~   "
41208|NCT03027362|"~     The goals of this study are: 1) to investigate the efficacy of combining ketamine with~     intensive cognitive behavioral therapy (CBT) to sustain the antidepressant effects of~     ketamine; and 2) to determine ketamine's delayed effects on learning and memory, and to~     explore the relationship between any ketamine-induced changes in learning and memory and~     duration of antidepressant efficacy, with and without CBT augmentation. Subjects with a~     diagnosis of MDD who are treatment-resistant to at least 2 antidepressants and have chosen to~     pursue clinical ketamine treatment at Yale Psychiatric Hospital will be recruited for the~     study.~   "
41245|NCT03026855|"~     The purpose of this study is to evaluate the safety and efficacy of autologous PRP injection~     in combination with topical application of PRP gel in treating chronic or non-healing ulcers~     on lower extremity using a rapid, intra-operative, point-of-care technology at the patient's~     bedside.~   "
41209|NCT03027349|"~     Background:~      Primary hyperparathyroidism (PHPT) is often overlooked and underdiagnosed. At present the~     diagnosis of PHPT remains challenging and is based on serum calcium (Ca) and PTH.~      As serum Ca and phosphorous (P) are inversely related in PHPT, the Ca/P ratio might be~     considered a good candidate tool in the diagnosis of PHPT.~      AIM: The aim of this study is to investigate the diagnostic value of the Ca/P ratio in the~     diagnosis of PHPT.~      Study design: Retrospective, observational, cross-sectional, case-control clinical trial will~     be carried out.~      Biochemical measurements will include PTH, Vitamin D, serum Ca, P, albumin, and creatinine.~   "
41210|NCT03027336|"~     The overall objective of the study is to assess the efficacy of Coleosoma formulation~     (fermented red rice, berberine and chitosan) in reducing non-HDL cholesterol in dyslipidemic~     patients.~   "
41211|NCT03027323|"~     Undifferentiated hypotension is a medical emergency where a patient's blood pressure drops to~     critical levels due to several possible reasons. The medical staff treating the patient will~     need to find out the reason for your drop in blood pressure as soon as possible. When~     treating low blood pressure, the medical staff typically performs a procedure called central~     venous cannulation (CVC). CVC involves accessing a large vein (usually the subclavian under~     the collarbone) by inserting a needle into the vein. By doing this, the medical staff can~     measure the pressures in the patient's veins or give medicine to the patient while they are~     in the hospital.~      The purpose of this study is to compare the time needed to complete CVC using the AxoTrack~     device to CVC guided by landmarks on a patient's body. The investigators expect that there~     will be a maximum of 30 patients enrolled in this study.~   "
41212|NCT03027310|"~     Background:~      Researchers have some data on how the brain controls movement and why some people have~     tremor. But the causes of tremor are not fully known. Researchers want to study people with~     tremor to learn about changes in the brain and possible causes of tremor.~      Objective:~      To better understand how the brain controls movement, learn more about tremor, and train~     movement disorder specialists.~      Eligibility:~      People ages 18 and older with a diagnosed tremor syndrome~      Healthy volunteers ages 18 and older~      Design:~      Participants will be screened with:~        -  Medical history~        -  Physical exam~        -  Urine tests~        -  Clinical rating scales~        -  Health questions~        -  They may have electromyography (EMG) or accelerometry. Sensors or electrodes taped to~          the skin measure movement.~      Participation lasts up to 1 year.~      Some participants will have a visit to examine their tremor more. They may have rating~     scales, EMG, and drawing and writing tests.~      Participants will be in 1 or more substudies. These will require up to 7 visits. Visits could~     include the following:~        -  EMG with accelerometry~        -  Small electrodes taped on the body give small electric shocks that stimulate nerves.~        -  MRI: Participants lie on a table that slides into a cylinder that takes pictures of the~          body while they do simple tasks.~        -  Small electrodes on the scalp record brain waves.~        -  A cone with detectors on the head measures brain activity while participants do tasks.~        -  A wire coil held on the scalp gives an electrical current that affects brain activity.~        -  Tests for thinking, memory, smell, hearing, or vision~        -  Electrodes on the head give a weak electrical current that affects brain activity.~        -  Photographs or videos of movement~      Participant data may be shared with other researchers.~   "
41213|NCT03027284|"~     The main purpose of this study is to evaluate tolerability of merestinib monotherapy or in~     combination with other anti-cancer agents in Japanese participants with advanced and/or~     metastatic cancer.~   "
41214|NCT03027258|"~     The investigators propose to adopt sustainable community networks (in this case churches) to~     implement an integrated community-based screening that incorporates mobile health technology~     (mHealth) to make prenatal test results available at the point-of-delivery to guide medical~     management.~   "
41215|NCT03027245|"~     Study E7389-M044-504 is an observational, post-authorization, single-arm, prospective,~     multicenter cohort study conducted to characterize and determine the incidence of~     eribulin-induced peripheral neuropathy (PN), and the frequency and time to resolution of~     eribulin-induced PN in participants treated with eribulin in a real-life setting for locally~     advanced or metastatic breast cancer following one or two prior chemotherapeutic regimens for~     advanced disease.~   "
41216|NCT03027232|"~     The protocol is to draw peripheral blood from healthy volunteers for in vitro studies. The~     aims of these in vitro studies are to determine the cellular and intracellular mechanisms by~     which hypertonic saline and ATP release regulate neutrophil and lymphocyte functions.~   "
41217|NCT03027219|"~     We aim to evaluate the flow change of arterial anastomosis site during free flap surgery in~     diabetic patients.~   "
41218|NCT03027206|"~     Objective to evaluate the effects of vibration techniques and acceleration of expiratory flow~     on pain parameters in preterm infants diagnosed with pneumonia hospitalized in the Intensive~     Care Unit and Neonatal Intermediate Care Unit. The Method is a descriptive and interventional~     study, in which 28 PTNB were randomly divided into two groups: Group 1 submitted to the~     vibration technique and Group 2 - to the acceleration of the expiratory flow, both techniques~     were applied in an interval of up to ten minutes, for Three consecutive days. The pain~     indicators were evaluated according to the PIPP scale in three moments. For statistical~     analysis, the Friedman tests and Variance Analysis were applied, the level of significance~     adopted was 5%.~   "
41219|NCT03027193|"~     A phase I dose escalation study to assess the safety and immunogenicity of the candidate~     vaccine ChAdOx2 HAV in healthy volunteers.~      Volunteers will be recruited and vaccinated in Oxford, England.~      All vaccinations will be administered intramuscularly. Three different doses will be tested~     (5x10^9 vp, 2.5x10^10 vp and 5x10^10vp).~      The total duration of the study will be 52 weeks from the day of enrolment for all~     volunteers.~   "
41220|NCT03027180|"~     Question: What level of noninvasive positive airway pressure is able to expand the lungs of~     people with pleural drainage? Design: Cross-sectional, experimental and randomized study.~     Participants: Four consecutive people with pleural effusion drained within 24 hours, with~     controlled pain and without contraindications to use of noninvasive positive pressure.~     Intervention: Each person will be randomly subjected to three levels of noninvasive positive~     airway pressure: 0 (zero), 4 and 15 cmH2O for evaluation via chest computed tomography.~     Outcome measures: Lung area.~   "
41221|NCT03027167|"~     The Purpose is to compare the safety and efficacy of the use of aspirin(ASA) with medical~     compression devices versus aspirin alone for venous thromboprophylaxis following knee and hip~     arthroplasty.~   "
41222|NCT03027154|"~     In this clinical research,48 cases TB (Tuberculosis patients) participants and 48 cases~     non-TB participants with lung disease who all meet the standard are divided into different~     groups through a randomized and blind method. Every subject inject intradermally ESAT6-CFP10~     and TB-PPD (tuberculin purified protein derivative) in different arms of the same person by~     blind method. Specific gama-interferon (γ-IFN) detection is needed before the~     injection.Measure the induration and (or) redness of longitudinal diameter size and~     transverse diameter vernier caliper by vernier caliper after injection 24h, 48h and 72h. At~     the same time, we observe all kind of adverse events in order to assess the safety of drug.~   "
41223|NCT03027141|"~     The purpose of the proposed study is to use functional magnetic resonance imaging (fMRI) to~     investigate how a change in facial appearance is initially represented in brain circuits and~     then alters over time, as the new face becomes recognized as me.~      Investigators will try to identify areas of the brain responsible for processing and storing~     information about self-facial recognition; Examine how these areas of the brain respond to~     images of self and non-self and; Investigate how the brain responds, over time, to~     changes in facial recognition, particularly at time points: i) prior to facial injury, ii)~     post-injury but prior to facial transplantation, and iii) after receiving facial~     transplantation.~   "
41224|NCT03027128|"~     The purpose of this study is to determine whether haNK™ for Infusion is safe and effective in~     the treatment of metastatic or locally advanced solid tumors.~   "
41225|NCT03027115|"~     Investigating whether pre-operative treatment with a selective alpha1-adrenoceptor antagonist~     affects the likelihood of male patients developing post-operative urinary retention following~     hernia repair.~   "
41226|NCT03027102|"~     This study aims to determine the safety and toxicity of incremental doses of Double Negative~     T (DNT) cells in human subjects with high risk acute myeloid leukemia (AML). DNT cells are~     mature T lymphocytes that comprise ~1% of white blood cells in humans. Injection of DNTs from~     healthy donors has been demonstrated to be effective against AML cells. DNT cells will be~     collected from healthy volunteers and injected into patients.~   "
41227|NCT03027089|"~     Aspergillus-specific IgG assays for the diagnosis of chronic pulmonary aspergillosis (CPA)~   "
41228|NCT03027076|"~     This research is being done to learn more about the bacteria that live in the genito-urinary~     tract in subjects with urologic chronic pelvic pain syndrome (UCPPS).~   "
41229|NCT03027063|"~     This research is being done to determine whether exercise while receiving doxorubicin or~     Adriamycin chemotherapy for breast cancer can reduce the cardio-toxic effects of this~     treatment on the heart and improve other outcomes related to cancer such as tumor markers,~     nausea, fatigue and the ability to tolerate chemotherapy.~   "
41230|NCT03027050|"~     It was aimed to evaluate the contributions of T-PRF treatment combined with open flap~     debridement on biological markers in GCF and periodontal outcomes in chronic periodontitis~     patients. 29 patients (58 sites) with chronic periodontitis were treated either with~     autologous T-PRF with OFD or OFD alone. GCF growth factor levels and relative RANKL/OPG ratio~     at baseline and 2, 4 and 6 weeks postoperatively were analyzed, and clinical parameters such~     as probing depth (PD), relative attachment level (RAL) and gingival margin level (GML) at~     baseline and 9 months after surgery were compromised.~   "
41231|NCT03027037|"~     This study, funded by the John Templeton Foundation, will examine birth and the early~     postpartum period (BEPP) as a transformative life experience that may shift women's~     experience of emotion in such ways as to a) support enhanced other-oriented emotions and b)~     underlie risk or resilience from psychopathology.~   "
41232|NCT03027024|"~     This is a prospective, non-randomised, controlled, single-surgeon, single-center post-market~     clinical follow up study whereby patient undergoing routine cataract surgery will have~     bilateral implantation of a recently introduced TGA (Therapeutics Goods Authority, Australia)~     approved trifocal intraocular lens FineVision Evo (PhysIOL, Liège, Belgium). The primary and~     secondary effectiveness data for visual acuity, defocus curves, contrast sensitivity and any~     adverse events will be collected.~   "
41233|NCT03027011|"~     This is a randomized controlled trial designed to test an intervention (Remote ischemic~     preconditioning) in patients undergoing carotid endarterectomy (CEA).Remote ischemic~     preconditioning(RIPC) with transient upper limb ischemia/reperfusion is a novel, simple,~     cost-free,non-pharmacological and non-invasive strategy.The purpose of this study is to~     evaluate the effects of Remote Ischaemic Preconditioning on perioperative ischaemic injury in~     patients undergoing carotid endarterectomy compared to control intervention.The outcomes of~     interest include neurocognitive function,clinical outcomes,and biomarkers of brain injury.~   "
41234|NCT03026998|"~     The purpose of this study is to assess the benefit of MR screening for asymptomatic head &~     neck (or CNS) second primary cancers occurring in hereditary retinoblastoma patients~     previously treated by external beam radiation therapy (EBRT).~   "
41235|NCT03026985|"~     The purpose of this study is to describe the changes in quadriceps muscle size and quality~     over the first 10 days on extracorporeal membrane oxygenation (ECMO) using ultrasound~     imaging. This study will also examine the relationship between those changes and muscle~     strength and level of physical function at day 10 and day 20 after ECMO commencement.~   "
41236|NCT03026972|"~     There are four populations in Recombinant Mycobacterium tuberculosis Vaccine Freeze-dried~     (AEC/BC02) phase I clinical research. The clinical study adopt open research design.~      Population I have 25 subjects who received Tuberculin purified protein derivative(TB-PPD)~     skin test and specific gamma-interferon (γ-IFN)detection whose results are both negative~     ;Population II have 30 subjects who received Tuberculin purified protein derivative(TB-PPD)~     and ESAT6-CFP10 skin test in different arms , specific gamma-interferon (γ-IFN) detection~     whose results are all negative.We call polulation III as uninfected TB PPD positve~     population.This group screened 30 subjects whose ESAT6-CFP10 skin test and specific~     gamma-interferon (γ-IFN)detection results are both negative,but Tuberculin purified protein~     derivative(TB-PPD) skin test positive.50 subjects whose three kinds of detection results are~     all positive γ-IFN,TB-PPD and ESAT6-CFP10 ) are named as population IV.~      After filtrating, injecting of population I start firstly.After ensure the safety of the~     population I,the population II～polulation IV carry out in turn the implementation at the same~     time.~   "
41237|NCT03026959|"~     There is preliminary empirical support for the use of mindfulness interventions during the~     perinatal period; suggesting that mindfulness training may be an effective treatment approach~     for reducing depression and anxiety symptoms during pregnancy and reducing anxiety, stress,~     and psychological distress during the postpartum period. To extend on these findings, the~     purpose of this research is to evaluate the effectiveness of a brief mindfulness-based~     program in protecting maternal mental health and well-being using a randomized controlled~     trial.~   "
41238|NCT03026946|"~     The purpose of this study is to compare the efficacy of alitretinoin and cyclosporine in the~     treatment of patients with severe recurrent vesicular hand eczema.~   "
41239|NCT03026933|"~     To examine variation rate of Non-HDL with KI1107 comparison Rosuvastatin monotherapy.~   "
41246|NCT03026842|"~     Acute myeloid leukemia (AML) is the most common hematological malignancies in adult patients~     with leukemia, and t(8;21) AML accounts for a substantial proportion of AML. AML patients~     with t(8;21) possess a favorable outcome and 3 - 4 course high dose cytarabine (3 g/m2) is~     the standard consolidation therapy for these patients with a 5-year overall survival~     approximately 60%. In China, intermediate dose cytarabine (1 - 2 g/m2) is used for~     consolidation therapy due to toxicities. After 3 - 4 course cytarabine consolidation,~     maintenance therapy is performed with conventional chemotherapy with a 5-year overall~     survival approximately 60% as well. However, continuous chemotherapy may cause toxicities and~     inhibit patients' immune response. Exploring new drug for maintenance therapy is urgently~     needed. Decitabine has a potent ability to inhibit proliferation and induce apoptosis of~     AML1-ETO positive leukemia cell line. Furthermore, the immunomodulatory effect of decitabine~     was also reported by several studies. In this study, the investigators plan to carry out a~     prospective, multicenter, randomized, controlled trail to compare decitabine versus~     conventional chemotherapy for maintenance therapy of patients with AML with t(8;21). Results~     of this trial may optimize the treatment for AML patients with t(8;21) in the setting of~     intermediate dose cytarabine consolidation.~   "
41247|NCT03026829|"~     The aim of this exploratory study is to evaluate the use and effectiveness of sound therapy~     for tinnitus relief in cochlear implant users with tinnitus. The sound therapy is a~     combination of tinnitus counselling and sound enrichment with the Cochlear Active Relief from~     Tinnitus (CART) firmware.~   "
41248|NCT03026816|"~     This study will evaluate a method to optimize parameter settings in epidural spinal cord~     stimulation used to recover lower extremity volitional movement. The study will also~     characterize improvement in autonomic function (such as blood pressure control) and other~     functions related to spinal cord injury.~   "
41249|NCT03026803|"~     This phase II trial is studying how well giving oxaliplatin and capecitabine together works~     in treating patients with liver cancer.~   "
41250|NCT03026790|"~     Background and significance: Treatment with opioid pain medications (like hydrocodone and~     morphine) is common for severe pain, but studies show these medications may not always help~     and can cause serious problems. High daily doses of opioids can be especially unsafe. To help~     patients with chronic pain have better quality of life and avoid medication toxicity, health~     care teams need to manage pain while helping patients reduce opioid medication doses to safer~     levels.~   "
41251|NCT03026777|"~     Endotracheal intubation is common in the care of critically ill patients. Complications of~     airway management in this setting are frequently encountered and may be associated with an~     increased risk of death. The prevention of complications during urgent and emergent~     endotracheal intubation is a key focus for airway management research. Post-intubation~     hypotension (PIH), a common complication of endotracheal intubation in the critically ill,~     may be prevented by a bolus of intravenous fluid prior to the start of the procedure, but~     this approach has not been examined in a prospective trial. There are no randomized trials of~     intravenous fluid administration to prevent PIH in critically ill adults. The investigators~     propose a randomized trial of fluid loading to prevent PIH in critically ill adults.~   "
41252|NCT03026764|"~     This study is a pragmatic randomized clinical trial comparing standard inpatient total hip~     arthroplasty with same day discharge. Patients who are medically well and have a good support~     structure at home will be randomized to inpatient or same day discharge. The investigators~     will compare patient costs from the perspective of the Ministry of Health, the institution,~     society and the patient. The investigators will also record complications, patient~     satisfaction, functional ability and quality of life.~   "
41253|NCT03026751|"~     10% of the cases referred to the specialist diagnostic haemato-pathology service at RMH are~     for cytopenias.~      The hypothesis to be tested is that a proportion of patients with idiopathic cytopenias have~     mutations in myelodysplasic syndrome (MDS)-associated genes. The investigators will sequence~     a panel of known MDS-associated genes in patient material (bone marrow and blood) that is~     sent routinely to the diagnostic service where conventional techniques have failed to~     establish a clear diagnosis. 200 patients with idiopathic cytopenia will be followed up to~     determine their survival, blood counts and development of acute leukaemia and other~     haematological malignancies. The clinical outcomes will be correlated with any mutations~     detected.~   "
41254|NCT03026738|"~     Aim of this work is to compare results between Laparoscopic Anterior Mesh Rectopexy and~     Laparoscopic Posterior Mesh Rectopexy for patients with rectal prolapse by assessment of~     operative time, intraoperative blood loss , intraoperative organ injury, overall length of~     hospital stay, recurrence,and improvement of incontinence and constipation.~   "
41255|NCT03026725|"~     Teeth sensitivity is the most popular symptom when using At-Home tooth whitening. Tri calcium~     phosphate containing pastes may affect the efficacy and postoperative sensitivity associated~     with At-Home vital tooth whitening using 20% carbamide peroxide~   "
41256|NCT03026712|"~     The two cerebral hemispheres find themselves in a state of balanced mutual inhibition. A~     stroke with involvement of motor function leads to a reduced excitability in affected~     hemisphere M1 and to an increased excitability of contralateral M1. Stroke therefore might~     impair interhemispheric balance, leading to a decreased inhibition of contralesional~     hemisphere by ipsilesional hemisphere and, in turn, to an increased inhibition of~     ipsilesional hemisphere by contralesional hemisphere. Permanence of healthy hemisphere~     hyperactivation in chronic phase after stroke is usually index of little functional recovery~     and is correlated with a greater ipsilateral structural damage.~      Robot-mediated physical therapy is an innovative rehabilitation technique that is effective~     in stroke patients. In this study, the investigators will add a non-invasive brain~     stimulation protocol with Transcranial stimulation with direct current (tDCS) to the robotic~     treatment in chronic stroke patients. tDCS is a non-invasive brain stimulation technique that~     is able to modulate cortical excitability. The hypothesis is that dual t-DCS (ipsilesional~     excitation and concomitant contralesional inhibition) could restore interhemispheric balance~     improving the benefits of robotic therapy with Armeo Power®.~   "
41257|NCT03026699|"~     The purpose of the study is to learn more about neuro-oncology caregivers' quality of life~     and how friends and families help neuro-oncology cancer caregivers at different times during~     treatment.~   "
41266|NCT03026582|"~     Objectives: To assess the predictive value of IUS in children with IBD.~      Design: A prospective longitudinal cohort study.~      Setting: Institute of Gastroenterology, Nutrition and Liver Diseases, Schneider Children's~     Hospital.~      Participants: Children 2 years to 17 years (up to 200 patients) who have been diagnosed with~     either CD or UC.~      Main outcome measures: The changes in bowel wall thickness, assessed by IUS, during 2-year~     follow-up according to therapeutic regimen.~      Secondary outcome measures: Correlation of sonographic measures to clinical disease indices,~     serum inflammatory and other laboratory markers, fecal calprotectin, endoscopic and other~     radiologic measures performed as part of routine care.~   "
41267|NCT03026569|"~     This study aimed to verify whether orange juice, source of citrus flavonoids and vitamin C,~     may contribute to the treatment of patients with chronic hepatitis C.~   "
41268|NCT03026556|"~     The purpose of this study is to assess the safety and effectiveness of newly initiated~     dabigatran among patients diagnosed with non valvular atrial fibrillation (NVAF) in~     comparison to newly initiated rivaroxaban users and newly initiated apixaban users~   "
41269|NCT03026543|"~     This prospective, blinded, randomized clinical trial investigates the effect on postoperative~     pain and nausea, when performing a ventilator-piloted PRM at the end of a laparoscopic~     cholecystectomy.~   "
41270|NCT03026530|"~     The purpose of this prospective, blinded, randomized clinical trial is to investigate whether~     a ventilator-piloted PRM at the end of laparoscopic bariatric surgery could reduce overall~     postoperative pain and nausea.~   "
41271|NCT03026517|"~     The purpose of this study is to test whether it is safe to give phenformin with the standard~     drug combination of dabrafenib + trametinib. The combination of dabrafenib plus trametinib is~     a standard treatment for patients with metastatic melanoma whose melanoma has a mutation in a~     gene called BRAF.~   "
41272|NCT03026504|"~     This study will evaluate the safety and effectiveness of baricitinib in the treatment of~     giant cell arteritis. All participants will be taking prednisone at the start of the study.~     The prednisone will be reduced according to a standardized tapering schedule while~     participants continue to take one tablet of baricitinib daily for 52 weeks.~   "
41273|NCT03026491|"~     The investigators aim to evaluate chewing function in children with repaired esophageal~     atresia-tracheoesophageal fistula (EA-TEF). Patients with repaired EA-TEF will be evaluated~     for age, sex, type of atresia. Each child will be required to bite and chew a standardized~     biscuit. Chewing function will be scored with the Karaduman Chewing Performance Scale (KCPS).~     The International Dysphagia Diet Standardisation Initiative (IDDSI) will be used to determine~     the tolerated food texture of children.~   "
41274|NCT03026478|"~     Oral Lichen Planus (OLP) is an autoimmune, chronic inflammatory mucocutaneous disease~     characterized by pain and burning sensation. The major types of OLP are the following:~     reticular, atrophic, erosive-ulcerative, bullous and pigmentous form.Its etiology remains~     unclear. The presence of auto-cytotoxic T cell clones in the lesions suggests the role of~     autoimmunity. Numerous treatment options of OLP include topical and systemic agents depending~     on severity of lesions . Topical corticosteroids abide the mainstay of therapy,and are widely~     accepted as the primary treatment of choice.Hence this study is designed to evaluate and~     compare the clinical efficacy of topical Clobetasol 0.05% in orabase and Betamethasone 0.05%~     in orabase in combination with Clotrimazole 1% in the management of symptomatic Oral Lichen~     Planus.~   "
41275|NCT03026465|"~     The objective of the present study is to determine the relation between vascular injury~     induced by the stent and strut thickness.~   "
41276|NCT03026452|"~     To evaluate the safety and efficacy of ultrasonography (US) -guided radiofrequency ablation~     for liver tumors, the investigators used preoperative and postoperative~     US/CEUS(contrast-enhanced ultrasonography)/CT/MRI to assess lesions, and laboratory tests~     including the tumor markers to evaluate the general condition of patients. Intraoperative~     US/CEUS/CT would be applied to monitor ablation lesions.~   "
41277|NCT03026439|"~     The aim of this study is to determine if presence of dyspnea identifies differences in the~     6-min walk test performance among smokers with normal or mild spirometric obstruction,~     accounting for the confounding effect of heart failure on dyspnea with stress~     echocardiography.~   "
41278|NCT03026426|"~     Background: Depression is a common comorbidity of physical chronic diseases such as diabetes~     and/or hypertension and constitutes an important public health problem. It correlates~     negatively with the patients' quality of life and self-care, as well as compliance with~     medical treatment. In low- and middle-income countries depression often goes unrecognized and~     untreated, and there are limited human resources to treat depression and other mental~     problems.~      Aim: The present study aims to test a 6-week low-intensity psychological intervention (CONEMO~     - CONtrol EMOcional) delivered by a smartphone application to people with depressive symptoms~     and co-morbid diabetes and/or hypertension recruited in primary health care centers and~     public hospitals in Lima, Peru.~   "
41279|NCT03026413|"~     To compare the efficacy and safety of circumferential pulmonary vein isolation without~     contact force with the pulmonary vein antrum modification for patients of paroxysmal atrial~     fibrillation.~   "
41280|NCT03026400|"~     While some studies have suggested that subumbilical and transumbilical incisions have a~     similar clinical efficiency and safety, no study has yet evaluated their respective impact on~     patient's postoperative aesthetic satisfaction.~      The objective of this randomised trial is to compare patient's postoperative aesthetic~     satisfaction depending on the type of incision which is performed during surgeries.~   "
41308|NCT03026036|"~     This study investigates stress-related signaling of glutamate and dopamine within the~     reward-processing circuit in Major Depressive Disorder (MDD), and whether they can be used to~     predict depressive symptoms in the future. This will be achieved through various neuroimaging~     tools (MRS, fMRI, PET), behavioral tasks, and a naturalistic follow-up design.~   "
41309|NCT03026023|"~     This is a proof of concept, single center study for the donation of HCV-positive hearts to~     HCV negative recipient patients, with preemptive, interventional treatment with 12-16 weeks~     of grazoprevir and elbasvir (with or without ribavirin) to prevent HCV transmission upon~     transplantation.~   "
42244|NCT03013790|"~     The investigators are studying the use of Melatonin in non-ventilated patients over the age~     of 65. Primary endpoint will be assesments of delirium, with secondary endpoints to include~     length of stay, use of anti-psychotic medications, and mortality~   "
41281|NCT03026387|"~     Suicidal behavior (SB) is a major public health problem in France, with over 10,000 suicides~     (6th in the EU28) and 220,000 suicide attempts (SA) per year. These data seem underestimated~     by 20%. A large percentage of men (6%) and women (9%) in France made at least one lifetime~     SA. In addition, SBs are common among young people and are the second leading cause of death~     among 15-44 year-olds. The interaction of multiple factors in SB complicates the creation of~     predictive models. These are currently imprecise and prevent the development of consensual~     recommendations for the management of suicidal patients.~      Most suicide attempters are evaluated in the emergency room where it is imperative to~     identify people with a high risk of relapse. Risk assessment is generally based on the~     experience of the practitioner who uses psychometric scales as support for clinical~     decisions. This assessment could be improved and supplemented by other sources of~     information. Thus, we aim to develop a short and specific tool that combines:~        1. Neurocognitive measures carried out using computer software on domains strongly~          associated with SB: impulsivity, affective dysregulation, alterations in decision-making~          (risky choices), selective attention and verbal fluency.~        2. Clinical and psychological assessment including the most predictive items of future SA:~          life events (environment) and personality traits (vulnerability). Suicide attempters~          will be assessed for SB and suicidal ideation in the emergency department. These~          measures will be repeated during a 12-month follow-up. We will use the data obtained to~          provide a more accurate measure of risk.~   "
41282|NCT03026374|"~     Breast cancer is the most prevalent cancer in women and annually accounts for 10% of new~     malignancies worldwide. In mainland China, approximately 169,000 females are diagnosed with~     breast cancer every year and constitute 12.25% of the breast cancer incidents worldwide.~     Additionally, 30% of early breast cancer turns metastatic, which is often incurable.~     Different from women with early breast cancer, women with metastatic breast cancer(MBC)must~     receive lifelong treatment, experience higher levels of emotional/physical distress, and feel~     frequent uncertainty about their health/possible death. They are also challenged to manage~     distressing adverse effects induced by different adjuvant treatments and experience heavy~     self-care demands during the transition period from being a patient to being a survivor.~     Thus, specific interventions to help women with metastatic breast cancer to recover from this~     traumatic event have been designed, and one of these is supportive-expressive group~     therapy(SEGT).SEGT has been found to achieve improvement in anxiety, depression, quality of~     life (QoL), family functioning, and satisfaction with treatment. However, the effect of SEGT~     on survival is inconsistent. Initial studies examining SEGT have reported a mean survival~     advantage of 18 months, however, these findings could not later be replicated.Yet, no study~     has reported a survival disadvantage for those given SEGT. In addition, we found no published~     articles on the application of SEGT among women with MBC in China. Owing to this dearth of~     previous research, it is unclear whether this therapy would exhibit positive effects within~     Chinese culture. Thus, we developed a Be Resilient to Breast Cancer(BRBC) program that is~     culturally tailored for Chinese females with MBC. This program was adapted from SEGT and is~     designed to increase resilience(defined as the capacity to bounce back after encountering a~     traumatic event) and QoL, decrease emotional and physical distress(allostatic load), and~     eventually prolong longevity. To better adapt to Chinese culture, we added education hosted~     by professional staff (e.g., clinical psychologists, dietician, Chinese medicine~     practitioner, etc.)in an effort to foster self-efficacy to combat symptoms (such as pain,~     fatigue, intrusive thoughts, etc.) through knowledge and technics (such as breath control,~     meditation, etc.),and to help patients gain a sense of control in their life. Second, trained~     mentors, who were breast cancer survivors themselves, were added to the group discussion to~     create non-hierarchical, reciprocal relationships through the sharing of experiences with~     those facing similar challenges. These mentors also provided women with first-hand~     information about treatment and offered suggestions to combat barriers to recovery.~   "
41283|NCT03026361|"~     The aim of this study was to examine molecular alterations on the protein level in lesions of~     oral lichen planus (OLP), oral squamous cell carcinoma (OSCC) and healthy mucosa. Global~     protein profiling methods based on liquid chromatography coupled to mass spectrometry were~     used, with a special emphasis on evaluation of deregulated extracellular matrix molecules~     expression, as well as on analyses of insulin-like growtg factor 2 (IG2F) and insulin-like~     growth factor 2 receptor (IGFR2) expression in healthy mucosa, OLP and OSCC tissues by~     comparative semiquantitative immunohistochemistry.~      Mass spectrometry based proteomics profiling of healthy mucosa, OLP and OSCC tissues (and~     accompanied histologically unaltered tissues, respectively) identified 55 extracellular~     matrix proteins. Twenty among identified proteins were common to all groups of samples.~     Statistically significant difference between final IGF2 and IGF2R IRS scores in favour to~     IGF2R may further corroborate the IG2FR antitumor role in OLP and OSCC where it acts as a~     negative regulator of IGF2 activity.~   "
41284|NCT03026348|"~     This is a randomized, observer-blind, trial in clinically-stable older adults. Up to 300~     eligible older adults 60 through 80 years of age will be enrolled at a 1:1 ratio into~     multiple dose/formulation treatment arms. Safety and immunogenicity data through Day 56 will~     be used to select a vaccine candidate to potentially evaluate in a Part 2 study. Proportions~     of subjects in various strata will not be pre-specified and the goal will be to achieve an~     approximately equal distribution of subjects with these characteristics across the treatment~     groups. Serology measures consistent with the study outcomes will be reported.~   "
41285|NCT03026335|"~     The purpose of the study is to use existing school resources and improve identification,~     referral and local support for children that exhibit exposure to childhood trauma resulting~     from environmental violence in Belize City. The Ministry of Education has identified the~     goals of the project to reduce violent behaviors in primary school children and supporting~     those children that have been exposed to violence or other malicious behavior that would~     inhibit normal school functioning. In addition, the MOE is supporting additional resources~     and data collection for a comprehensive evaluation of student behavior and academic~     performance.~   "
41286|NCT03026322|"~     Complications are common during endotracheal intubation of critically ill adults. Manual~     ventilation between induction and intubation (bag-valve-mask ventilation) has been proposed~     as a means of preventing hypoxemia, the most common complication of intubation outside the~     operating room. Safety and efficacy data, however, are lacking. PreVent is a randomized trial~     comparing manual ventilation between induction and laryngoscopy to no manual ventilation~     between induction an laryngoscopy during endotracheal intubation of critically ill adults.~     The primary efficacy endpoint will be the lowest arterial oxygen saturation. The primary~     safety endpoints will be the lowest oxygen saturation, highest fraction of inspired oxygen,~     and highest positive end-expiratory pressure in the 24 hours after the procedure.~   "
41287|NCT03026309|"~     Main objectives: Comparing levels of F-DOPA reuptake rate as an indicator for Dopamine~     metabolism of un-medicated Depressed patients to healthy individuals in the Mesocorticolimbic~     System (VTA-NAc-PFC) and assessing structural differences between the two groups in the~     Hippocampus, Hypothalamic-Pituitary gland and Mesocorticolimbic System (VTA-NAc-PFC) and~     resting state fMRI.~      Secondary objectives: 1. Comparing the differences of DNA Methylation in the plasma and serum~     of patients compared to healthy controls. 2.Assessing the correlation between symptoms'~     severity score (evaluated based on Hamilton Rating Scale) at base line and 6 months following~     treatmnt to PET 18F-DOPA uptake repertoire in the Mesocorticolimbic System, structural~     measurements and DNA Methylation.~      Methodology: Study Design: A prospective, pilot study. 30 un medicated Depressed patients and~     30 Healthy volunteers will perform a [18F] FDOPA PET/MRI scans following a HAM-D~     questionnaire (Hamilton rating scale of depression) and blood tests.~      PET-MR (Biograph mMR, Siemens AG, Erlangen, Germany) scans will be performed using the tracer~     of dopamine precursor 3,4-dihydroxy-6-[18F]-fluoro-l-phenylalanine ([18F] FDOPA) that~     reflects L-dopa transport, L-aromatic amino acid decarboxylase activity, vesicular uptake and~     the number of dopamine nerve terminals. Measurements of dynamic F-DOPA parameters (Ki) and~     quantitative measurements of static F-DOPA ( SUVmax and SUVmean) will be performed in the~     ventral tagmental area (VTA), nucleus accombens (NAc) and pre-frontal cortex (PFC)which~     comprise the Mesocorticolimbic System, bilaterally. MRI sequences of T1, T2 3D measurements~     (assessing Volume) of the hippocampus, Hypothalamic-Pituitary gland and Mesocorticolimbic~     system, DTI measurements in the mesocorticolimbic dopaminergic tract and BOLD (resting-state~     f-MRI) in those brain networks. whole genome DNA Methylation from whole blood will be~     performed.~      To date there is no quantative standard of care evaluation tool that serves psychiatrists~     when assigning medication for newly diagnosed depressed patients. The manner in which~     medications are assigned are threw symptom evaluation and trial and error. Only a third of~     the patients achieve remission after the first line of treatment. SSRI's are most common type~     of medication used to treat Major Depression today. One third of patients remains un~     responsive even after the fourth line of treatment (of different types of medications). Anti~     depression medications way of action requires time to reach its effect and in many patients~     with no avail or even causing symptom's severity. The PET-MR multimodality imaging tool~     offers a cutting edge technology ideally fitted to measure brain disorders. The use of F-DOPA~     radio-ligand with the PET-MR constitutes a novelty in the imaging of the depressed brain.~     Dopamine is one of three of the monoamine neurotransmitters targeted by anti-depressive~     medication, sharing metabolistic agents. dopamine has been proven to be connected to the~     processing of emotion, motivation, hedonism and reward threw its action in the~     Meso-cortico-limbic system. Epigenetics is a regulatory system that determines gene~     expression. It is heritable in the one hand and reacts to environmental changes on the other.~     It has been shown to be involved in psychiatric disorders.~      PET-MR scans will be performed. DNA samples will be extracted from subject's whole blood~     samples taken prior to scans. Then it will be analyzed for whole genome DNA methylation.~     Taken together this novelty imaging technique and epigenetic mapping of peripheral markers~     can be used to better understand and personalize anti-depressive treatment compatibility.~   "
41288|NCT03026296|"~     A Healthy Life Center (HLC, 'Frisklivssentrale') is a public community-based health service~     providing lifestyle support programs for physical activity, smoking cessation and diet, to~     inhabitants with increased risk for development of non-communicable diseases. HLCs intention~     is to reach physically inactive people who need guidance to get more physically active, and~     offer them a lifestyle program for three months or more.~      The main aim of this study is to study whether the HLCs, organized according to the Norwegian~     Directorate of Health`s guidelines for municipal healthy life centers, affects the~     participants short term (3 months) and long term (15 months) physical activity level. Also~     changes in diet, tobacco use, health related quality of life, physical fitness,~     anthropometry, self-efficacy, motivation, drug use, use of health services and work~     participation will be assessed. Secondary aim is to study whether there are any moderators,~     such as HLCs capacity, expertise, and collaboration with other services, that have~     significance for participants' change. Also it will be studied whether the HLCs result in~     larger changes in some subgroups (e.g. socioeconomic) of participants than in others.~   "
41310|NCT03026010|"~     The aim of the study is to check standard screening blood pressure in the arm and central~     blood pressure, the blood pressure at the heart in pregnant women. The standard brachial~     pressure is routinely monitored throughout pregnancy, however it is not sensitive enough to~     distinguish preeclampsia from other types of hypertension or to predict preeclampsia in those~     at risk. Central aortic pressure monitoring has become a valuable clinical tool and~     preliminary studies suggest that measuring of central blood pressure may be better predictor~     of preeclampsia. It is non invasive and doesn't require undressing. It involves using a~     standard blood pressure cuff placed around the thigh, checking carotid pulse and pressure~     with an ultrasound and taking measurements of the person neck to torso. With this knowledge~     it will be a useful screening tool to identify these patients at higher risk and hopefully~     lead to closer monitoring, earlier treatment and reduced morbidity and mortality~   "
41289|NCT03026283|"~     Coronary Computed Tomography Angiogram (CCTA) is a non-invasive imaging modality that has~     high sensitivity and negative predictive value for the detection of coronary artery disease~     (CAD). The main limitations of CCTA are its poor specificity and positive predictive value,~     as well as its inherent lack of physiologically relevant data on hemodynamic significance of~     coronary stenosis, a data that is provided either by non-invasive stress tests such as~     myocardial perfusion imaging (MPI) or invasively by measurement of the Fractional Flow~     Reserve (FFR). Recent advances in computational fluid dynamic techniques applied to standard~     CCTA are now emerging as powerful tools for virtual measurement of FFR from CCTA imaging~     (CT-FFR). These techniques correlate well with invasively measured FFR [1-4]. The primary~     purpose of this study is to evaluate the incremental benefit CT-FFR as compared to CCTA in~     triaging chest pain patients in outpatient settings who are found to have obstructive CAD~     upon CCTA (> 30% and < 90% stenosis). Invasive FFR and short term clinical outcomes (90 days)~     will be correlated with each diagnostic modality in order to evaluate positive and negative~     predictive value of each when used incrementally with CCTA.~      Patients will undergo a CCTA, as part of routine care. If the patient consents to participate~     in the study and is found to have coronary stenosis of 30% to 90%, based on the~     cardiologist's reading, the CCTA study will be sent to HeartFlow, a vendor that will provide~     a computerized FFR reading, based on the CCTA study. If the noninvasive FFR diagnosis~     indicates obstructive disease, the patient will undergo cardiac catheterization with invasive~     FFR.~      As CCTA utilization increases, the need to train additional imaging specialists will~     increase. This study will assess the capability of FFR-CT to enhance performance on both~     negative and positive predictive value for less experienced readers by providing feedback~     based on CT-FFR evaluation. CCTA readers will be grouped in two categories: those with more~     than 10 years reading experience and those with less than 10 years reading experience. Each~     CCTA will be read by a less experienced and a more experienced reader. Results from each~     reader will be correlated with each other and with the CT-FFR and invasive FFR results.~   "
41290|NCT03026270|"~     Effect of therapeutical paraffin wax bath in the malleability of burned skin~   "
41291|NCT03026257|"~     The purpose of this study is to evaluate worn AIR OPTIX® plus HYDRAGLYDE® (AOHG) lenses~     cleaned and disinfected with HYDRAGLYDE® containing lens solutions compared to each of the~     control habitual silicone hydrogel (SiHy) lenses cleaned and disinfected with habitual~     multi-purpose solution (MPS) for cholesterol uptake.~   "
41292|NCT03026244|"~     Rationale: The immune system in the ageing population becomes compromised with age (termed~     Immunosenescence). Therefore, elderly people have a decreased ability to respond to~     infection and vaccination. Furthermore, many of the health issues associated with ageing are~     linked to inflammation (Inflammaging). It has been suggested that this compromised immune~     function is in part due to reduced Toll-like receptor (TLR) function, which is part of the~     innate immune system. Milk and dairy based products have been shown to have beneficial~     effects on inflammation and immunity. This effect may be mediated via support of the innate~     immune response and promotes TLR7 signaling in in vitro assays (unpublished observation).~     Also prebiotics have been suggested to influence markers of innate immune function.~     Furthermore, TLR function has been suggested to be correlated to vitamin D status. Therefore,~     in the current pilot study, the potential of milk protein, prebiotics and vitamin D to~     support innate immune function in elderly will be investigated.~      Objective: Aim of the current study is to evaluate the effect of milk protein on the innate~     immune response in elderly in a pilot study. Furthermore, support of this effect by~     prebiotics and Vitamin D will be studied.~      Study design: The study will be a double-blind placebo-controlled pilot study. Study~     population: Healthy female elderly subjects of 65-85 years of age. Intervention: Period 1:~     Milk protein or placebo. Period 2: Milk protein + prebiotics or placebo. Period 3: Milk~     protein + prebiotics + Vitamin D or placebo.~   "
41293|NCT03026231|"~     The purpose of this study is to characterize the intestinal flora in subjects with~     Parkinson's Disease (PD) and to determine safety and trends in improvements in diversity of~     colonic microbiome following fecal microbiota transplantation.~   "
41294|NCT03026218|"~     A critical variation in the provision of prenatal care to women with GDM is the need to keep~     patients engaged with their care between visits by tracking glucose levels using finger~     sticks and making dietary and other lifestyle modifications to keep these levels at or close~     to normal. Multiple studies have demonstrated that the use of mobile devices can improve~     medical outcomes. In order to keep patients engaged between appointments and improve~     self-care/lifestyle, we will study the use of a glucose monitoring system with nutrition~     therapy called GlucoseMama(GM). GM is a mobile app on the iOS system that individuals with~     GDM will use to tract blood sugars and number of carbs consumed. In addition, it will give~     the user positive feedback and rewards for using the system. This model of group care with~     mobile phone monitoring and reminders for women with GDM has not been previously studied. A~     randomized control trial is purposed to determine if this approach improves patient care. The~     investigators hypothesize that group prenatal care along with inter-session mobile therapy~     will increase dietary compliance and therefore reduce the number of individuals requiring~     pharmacologic therapy and improve neonatal outcomes during pregnancy. Group prenatal care~     (GPC) will provide a community foundation to improve learning and increase the motivation of~     patients to learn and change. This motivation will be further strengthened by the use of the~     GlucoseMama monitoring system which will provide each patient with glucose tracking and~     individualized nutritional support.~   "
41295|NCT03026205|"~     This is a single center study to evaluate the pharmacokinetics of ARMS-I a formulation that~     incorporates cetylpyridinium chloride (CPC), administered once as a single dose of three~     sprays orally, followed by multiple dosing (3x daily oral sprays) over days 3-6 and then a~     repeat pharmacokinetic study during the final oral dose administered as the first dose on day~     7 to ascertain CPC accumulation.~   "
41296|NCT03026192|"~     Using cerebral and renal near infrared spectroscopy monitoring to determine PDA closure in~     preterm infants after completing medical treatment for a hemodynamically significant PDA.~   "
41297|NCT03026179|"~     To determine if a brief primary care intervention can educate under-resourced and minority~     parents about discipline in a way that is culturally sensitive.~   "
41298|NCT03026166|"~     The purpose of this multicenter, Phase 1/2, open-label, study is to assess the safety and~     efficacy of rovalpituzumab tesirine administered in combination with nivolumab or nivolumab~     and ipilimumab in participants with extensive-stage small cell lung cancer (SCLC).~   "
41311|NCT03025997|"~     This study evaluates the ability of encapsulation of orally applied lipids in a yoghurt snack~     to modify ad libitum food intake and satiety, without GI symptoms. Every subject receives two~     treatments (active, and placebo) on two different days, following a randomized cross-over~     design.~   "
41478|NCT03023800|"~     Macular schisis associated with macular detachment is a one of the complications of high~     myopia. There is controversy in the primary treatment for this situation. This study will~     compare the effects of macular buckling + gas injection versus vitrectomy + internal limiting~     membrane peeling + gas tamponade in a cohort of highly myopic eyes with macular retinal~     detachment associated with macular schisis.~   "
41299|NCT03026153|"~     Biologics are used to treat conditions such as moderate-to-severe psoriasis, a chronic~     condition that impairs quality of life as much or more than other major medical conditions.~     Biopharmaceuticals are medications which are are isolated from biological sources including~     microorganisms, animals or humans. These medications generally function to decrease~     inflammation or disrupt the inflammatory cycle. Patients are often apprehensive about~     choosing a biologic medication over other options due to anxiety regarding the need for~     regular injections, leaving the patient undertreated and continuing to suffer with psoriasis.~     Reducing fears of injections may improve adherence to treatment and may improve treatment~     outcomes. Fear of injection is inherently subjective and may be easily modified. Anchoring is~     the tendency for humans to rely on a specific value when making decisions and to make~     judgments relative to that value. Patients who have never taken an injection will~     subjectively view the idea of taking an injection relative to the not taking any injection~     baseline. This comparison is scary and represents a considerable hurdle to taking a new~     injectable medication that may be otherwise optimal for their treatment. Resetting the anchor~     may be all that is needed to help patients overcome fear of injection. The objective is to~     assess whether patients offered a once monthly injectable biologic would be more likely to~     accept that biologic medication if they are first counseled about a daily injection.~   "
41300|NCT03026140|"~     In this exploratory study, patients with stage 1-3 adenocarcinoma of the colon with no signs~     of distant metastases will be treated with short-term immunotherapy + COX2-inhibitors. This~     treatment will be given during the window period until surgical resection of the tumor. The~     duration of treatment will be approximately 6 weeks.~   "
41301|NCT03026127|"~     The goal of this project is to refine and test a novel emotion-regulation based psychosocial~     intervention designed to reduce suicide risk in middle-aged and older adults (50-90 years~     old) who have been discharged after a suicide-related hospitalization (i.e. for suicidal~     ideation or suicide attempt). Suicide rates in this group are alarmingly high, and reducing~     suicide rates in at-risk populations is a major NIMH priority.~   "
41302|NCT03026114|"~     About 50% of all patients suffering from HF exhibit a reduced ejection fraction (EF ≤ 40%),~     termed HFrEF. The others may be classified into HF with midrange EF (HFmrEF, EF = 40-50%) or~     preserved ejection fraction (HFpEF, EF ≥ 50%).~      Up to now, there are no large scale studies evaluating patients with HFmrEF and/or HFpEF in~     Turkey. Scarce data are available in the middle-east populations in general and Turkish~     patients in particular, who have different etiology, ethnic, cultural backgrounds and risk~     factors from those patients in the West. The aim of this study was to study Turkish patients~     with HFmrEF and HFpEF, and define their clinical characteristics and the signs and symptoms~     of heart failure, echocardiographic findings and medications at admission. With this national~     study, we will evaluate how recommendations of most recent European guidelines regarding~     pharmacological and non-pharmacological treatments are adopted in clinical practice. We will~     also evaluate the prevalence of the clinical profiles of patients with HFmrEF and HFpEF,~     according to the definitions proposed by the European Society of Cardiology, and to~     investigate their appropriateness in characterizing patients with different clinical~     presentations and needs.~      Assessed outcomes included the causes of decompensation, use of medications, care quality~     indicators.~   "
41303|NCT03026101|"~     Migraine is the most common headache disorder, prevalent in 18% of females and 6% of males.~     Emergency room visits, physician consults, hospitalizations, medications, and indirect costs~     such as lost work days and decreased productivity place the global economic burden of~     migraines at over 20 billion dollars. It is prevalent in 28 million people in the US alone.~     Symptoms include unilateral, throbbing, debilitating headache pain accompanied by nausea,~     vomiting, photophobia, and phonophobia. Upwards of 75% of migraine patients have reduced~     functionability, have lost time at work, and 1/3 of patients require bed rest to manage the~     symptoms. The health-related impact on quality of life was comparable with that experienced~     by patients with congestive heart failure, hypertension, or diabetes.~      While the burden of migraines on our society is clear, the pathophysiology of migraines~     remains largely unknown. The trigeminovascular system, including the external and internal~     carotid arteries and their associated sensory fibers which subserve the head have long been~     implicated in the pain and cutaneous allodynia experienced by migraine patients. Wolff in~     1953, was the first to posit that migraine headache pain is the caused by dilation or~     circumferential expansion of the extracranial carotid artery. He demonstrated that~     migraineurs had twice the pulse amplitude in their external carotid arteries compared to~     control subjects and these changes were directly correlated to migraine symptoms. In a 2008~     study, randomized migraineurs received nitroglycerin via peripheral IV or placebo for 20~     minutes prior to obtaining magnetic resonance angiography (MRA). Nitroglycerin, a potent~     dilator of blood vessels, reliably induced migraine-like pain in up to 80% of patients, and~     transient dilation of vessels of up to nearly 40%, mostly in the extracranial vessels.~     Sumatriptan's efficacy in migraine relief provides further evidence for this theory, as it is~     a selective extracranial vessel constrictor which does not cross the blood brain barrier.~      The goal of this current work is to utilize the direct, real-time angiography, which provides~     a high resolution map of vasculature, and demonstrate changes in vessel flow in patients who~     have migraine headache attacks. This information may guide therapeutic interventions in the~     future in order to better treat these migraine patients.~   "
41304|NCT03026088|"~     This is a single-arm, open label, interventional, multi-center, phase IV pilot study.~   "
41305|NCT03026075|"~     The study is multi-center study ,planned as a single arm, open trial, aimed at evaluating the~     performance and safety of a colon cleansing device during a colonoscopy procedure in a poorly~     prepared colons.~      Total of 47 subjects are planned to be enrolled at 3 clinical sites (1 in Germany and 2 in~     the Netherlands).~      Subjects who meet the eligibility criteria will be screened for study participation at a~     baseline visit(visit 1). Subject who is eligible to the study will required to follow a~     specific preparation instruction starting 2 days prior to the colonoscopy with the Motus~     Cleansing System (MCS) procedure.~      Following the procedure a telephone follow-up will be conducted at 48 hours (± 24 hours) and~     14 days (± 3 days) post MCS procedure to assess patient well-being and capture any Adverse~     Events (AE).~   "
41306|NCT03026062|"~     The goal of this clinical research study is to test 2 types of dosing schedules of~     tremelimumab and durvalumab to learn if one is more effective in patients with high-grade,~     platinum-resistant epithelial ovarian, peritoneal, or fallopian tube cancer. The safety of~     the dosing schedules will also be studied.~      This is an investigational study. Neither durvalumab nor tremelimumab are FDA approved or~     commercially available for the types of cancer in this study. They are currently being used~     for research purposes only in these diseases. The study doctor can explain how the study~     drugs are designed to work.~      Up to 115 participants will have screening tests to learn if they are eligible to take part~     in this study. Up to 100 participants that are found eligible will be enrolled in this study.~     All will take part at MD Anderson.~   "
41307|NCT03026049|"~     Patients will be randomised between deep venous stenting or conservative management~   "
41312|NCT03025984|"~     Diabetes is a common complication of pregnancy that increases risks for both the mother and~     baby. Poorly controlled diabetes has been associated with very large babies, congenital heart~     defects, stillbirth, birth trauma, and maternal infections among other complications.~     Patients with diabetes in pregnancy require more frequent prenatal visits and fetal~     evaluation, and must shoulder the burden of mastering management of a complicated care~     regimen. With the ever-expanding world of technology, more healthcare practices are using~     cell phones, texting, and social media to interact with patients. Use of this technology has~     been successful in management of chronic diseases and as reminder systems. The investigators~     propose a randomized clinical trial to investigate patient adherence to recommended care~     regimen after intervention of a text message reminder and education system.~   "
41313|NCT03025971|"~     A prospective, multicenter, nonrandomized, single-arm, controlled target value study,~     designed to include no less than 82 patients in at least two (2) clinical centers in China.~   "
41314|NCT03025958|"~     Radiation Plus Concurrent Nimotuzumab in Elderly Patients With Locoregionally Advanced~     Nasopharyngeal Carcinoma~   "
41315|NCT03025945|"~     Prospective, randomized, double-masked, placebo-controlled clinical study to define the~     effective use of a topical non-steroidal anti-inflammatory drug added to topical steroid use~     after uncomplicated phacoemulsification for the prevention of pseudophakic cystoid macular~     edema.~   "
41316|NCT03025932|"~     Patients who underwent laparoscopic repair of large hiatal hernias and anterior~     fundoplication with mesh are examined for their recurrence rate one year after surgery.~   "
41317|NCT03025919|"~     Evaluation of using 2h-UG combined with FPG, AGEsP alone or in combination with FPG in~     diabetes screening in Chinese natural population~   "
41318|NCT03025906|"~     Although generalized convulsive status epilepticus (GCSE) is a life-threatening emergency,~     evidence-based data to guide initial drug treatment choices are lacking in the Chinese~     population. The investigators conduct this prospective randomized controlled trial to~     evaluate the relative efficacy and safety of intravenous (IV) phenobarbital (PB) and~     valproate (VPA) in patients with GCSE.~   "
41319|NCT03025893|"~     In this study the investigators will evaluate the effect of high-dose, intermittent sunitinib~     versus treatment with lomustine in patients with recurrent glioblastoma multiforme. The~     investigators hypothesize that sunitinib, when given in a high-dose, intermittent schedule,~     will achieve adequate concentration levels in the tumor and will, besides its anti-angiogenic~     properties, inhibit gliomagenesis by inhibition of multiple kinases.~   "
41320|NCT03025880|"~     Study Design and Treatment:~      This is a multicenter phase II trial, with an initial exploratory run-in-phase, to evaluate~     the efficacy and safety of pembrolizumab in combination with gemcitabine in patients with~     HER2-negative ABC that have previously received anthracyclines and taxanes (unless clinically~     contraindicated). In hormone receptor positive patients, previous treatment with 2 or more~     lines of hormone therapy will also be required. Patients must have at least one measurable~     lesion that can be accurately assessed at baseline and is suitable for repeated assessment by~     CT, MRI or plan X-ray. Approximately 53 patients (up to a maximum of 65 patients depending on~     the results of the run-in-phase) will be included in this trial.~   "
41321|NCT03025867|"~     This is an expanded access program (EAP) for eligible patients with Recurrent Ovarian Cancer.~      This program is designed to provide access to niraparib prior to approval by the US Food and~     Drug Administration (FDA).~      To be eligible, patients with Recurrent Ovarian Cancer following a partial (PR) or complete~     response (CR) to their most recent platinum-based chemotherapy and must have experienced a PR~     or CR after the penultimate (next to last) platinum-based chemotherapy for at least 6 months~     without disease progression after this chemotherapy.~   "
41322|NCT03025854|"~     The purpose of this clinical research project is to explore potential biomarkers and validate~     the predictive and prognostic value of molecular signature in nasopharyngeal carcinoma.~   "
41323|NCT03025841|"~     Pneumonia is the most frequent infection in critically ill patients and remains a significant~     challenge to intensivists world-wide due to persisting high mortality and morbidity.~     Compelling evidence suggests that appropriate antibiotic therapy remains the most important~     intervention to improve patients' outcome, including the administration of a suitable~     molecule at an optimized dosage regimen. A vast array of pathophysiological changes can occur~     in critically ill patients that can complicate antibiotic dosing. Knowledge of the~     pharmacokinetic and pharmacodynamic properties of the antibiotics used for the management of~     critically ill patients is essential for selecting the antibiotic dosing regimens, which will~     optimize patient outcomes. Changes in volume of distribution (Vd) and clearance (CL) of~     antibiotics have been noted in these patients, which may affect the antibiotic concentration~     at the target site. It follows that the pharmacodynamic parameters that determine antibiotic~     efficacy, which can vary between antibiotic classes, may also be affected. Optimization of~     these parameters is necessary to maximize the rate of response through patient recovery and~     minimized antibiotic resistance.~      In a multicenter observational study in critically ill patients with normal plasma renal~     indices at admission, about 65% of patients manifested augmented creatinine clearance on at~     least one occasion in the first seven study days. Augmented creatinine clearance may~     significantly impact drug pharmacokinetics for a variety of renally eliminated~     pharmaceuticals (such as low-molecular weight heparins, aminoglycosides, glycopeptides, and~     β-lactams), leading to subtherapeutic concentrations and potentially adverse clinical~     outcomes. Currently little data exist that describe the consequences of augmented creatinine~     clearance on antibiotics PK.~      Ceftaroline (600 mg bid) is a cephalosporin with expanded gram-positive activity, including~     MRSA and penicillin-resistant streptococcus, which was approved by the US Food and Drug~     Administration (FDA) on October 29, 2010 for the treatment of acute bacterial SSSIs and~     community-acquired bacterial pneumonia. Ceftaroline showed also good activity against some of~     the common gram-negative respiratory pathogens (eg, Haemophilus influenzae, Moraxella~     catarrhalis, Neisseria meningitidis, and Pasteurella multocida). However, it does not display~     clinically relevant activity against Pseudomonas aeruginosa, Stenotrophomonas maltophilia, or~     Acinetobacter baumannii. Ceftaroline also lacks activity against gram-negative organisms with~     extended-spectrum β-lactamases. Importantly, because ceftaroline appears to induce AmpC~     β-lactamases despite MIC values in susceptible range, ittheoretically should be avoided in~     gram-negative bacteria known to harbor inducible AmpC β-lactamases (eg, Serratia, Proteus,~     Citrobacter, Morganella, Enterobacter, Providencia, and P. aeruginosa). In patients,~     ceftaroline is given as a prodrug, ceftaroline fosamil. After intravenous administration, the~     prodrug is rapidly transformed by plasma phosphatase enzymes to its bioactive metabolite. The~     pharmacokinetics of ceftaroline has been evaluated in single and multiple dose studies in~     healthy volunteers, in subjects with various degrees of renal impairment and in healthy~     elderly subjects. The volume of distribution is equal to 20.3 L, which corresponds to~     extracellular fluid volume. The protein binding is low (20%). The main route of elimination~     is via renal excretion, with a clearance estimated to160 mL/min close to the creatinine~     clearance. The elimination half-live is 2.6 h in adults with normal renal function.~     Unfortunately, no PK study has been performed in infected critically ill patients with~     augmented creatinine clearance. The best PK-PD index predicting drug efficacy is %Time>CMI. A~     bacteriostatic effect is achieved when free drug concentrations exceed the MIC for 30 to 40%~     of the dose administration interval (30 to 40%T>MIC). Near maximum organism kill is achieved~     at 50 to 60%T>MIC (30%T>MIC for Staphylococcus aureus).~      This project aims to characterize ceftaroline PK in patients with early-onset pneumonia and~     augmented creatinine clearance. The choice of ceftaroline is justified by its spectrum~     suitable for micro-organisms commonly encountered in early onset pneumonia, including~     methicillin-resistant Staphylococcus aureus. Secondary main objective is to predict the~     probably of reaching PK-PD targets using Monte Carlo simulations under various scenario in~     order to identify optimal ceftaroline administration schemes in critical care patients with~     various degrees of renal impairment.~   "
41324|NCT03025828|"~     The purpose of this study is to evaluate the effect of adrenocorticotropic hormone (ACTH,~     Acthar) on the loss of proteins in the urine (proteinuria) in patients with membranous~     nephropathy. Acthar is a hormone that stimulates steroid production from small glands above~     the kidneys. It has direct protective effects on the kidney and is currently approved by the~     FDA to treat kidney disorders associated with proteins in the urine, but the mechanisms of~     action are not entirely understood and will be studied in the present trial.~   "
41325|NCT03025815|"~     The purpose of this study is to determine whether oral stimulation program are effective to~     improve oral feeding efficiency. The sample size estimated in 74 preterm, randomized~     classification of the subjects into to experimental and a control group.~   "
41326|NCT03025802|"~     The FAPIC project will develop a diagnostic system that will identify pathogens and~     charachterize virulence and resistance. A prospective study will be performed in which blood~     samples will be collected of patients with suspected sepsis in order to evaluate the~     diagnostic system. In routine care, blood is drawn of these patients for culture in order to~     identify the causative pathogen. This process takes 3-5 days. During the study, one extra~     blood sample will be collected with the same venipuncture, with each blood culture.~     Afterwards, routine diagnosis by blood culture is followed. Blood samples will be send to the~     research laboratories for determination of sensitivity and specificity. The system will not~     be used in the clinic.~   "
41327|NCT03025789|"~     This study evaluates the effectiveness of fexinidazole administered to patients with g-HAT at~     all stages of the disease. The aim of the present study is to provide additional information~     on the effectiveness and safety of fexinidazole and to assess its use under conditions as~     close as possible to those in real life, both in patients treated on an out-patient basis and~     in the hospital setting, depending on clinical status~   "
41348|NCT03025516|"~     This will be a prospective, multicentre study conducted to evaluate the diagnostic accuracy~     of two TB breath-based technologies independently of the manufacturers. Assay error and~     failure rates and device operational characteristics will also be assessed during this study.~     Participants will be enrolled in this study in line with FIND sample banking activities.~     Results from index tests will not be used to make clinical decisions. Participation in this~     study will not alter the standard of care.~   "
41479|NCT03023787|"~     To evaluate the safety and tolerability of Hepalatide(L47) and characterize the clinical~     pharmacokinetics in healthy volunteers.~   "
41328|NCT03025776|"~     To further develop interventions, the investigators need a better understanding of which task~     requirements (i.e. size or weight of object, location in workspace, etc.) drive a person~     after stroke to use 2 hands (as opposed to 1), and how the severity of their injury impacts~     this relationship and compare this to reaching in age-matched healthy controls subjects. A~     better understanding of this relationship will promote more informed development of~     rehabilitative interventions. This study proposes to explore in people after stroke and~     healthy controls: i.) how specific functional tasks requirements relate to 1 vs. 2 handed~     use, and ii.) how stroke severity impacts this arm use. We are proposing to study 15~     individuals more than 6 months after stroke in the CSU Motor Behavior Lab for a two x 3 hour~     session of task-related reaching in sitting and 33 age matched (double sample size) healthy~     controls. The investigators will systematically vary task requirements (i.e. object size or~     weight, location in workspace, etc.), and record use of 1 versus 2 hands using videotaping as~     well as recording of quality of arm movement (kinematics) and muscle activity (EMG) in both~     arms.~   "
41329|NCT03025763|"~     Craniosynostosis (CS) is a common malformation occurring in ~4 per 10,000 live births in~     which the sutures between skull bones close too early, causing long-term problems with brain~     and skull growth. Infants with CS typically require extensive surgical treatment and may~     experience many perioperative complications, including hemorrhage and re-synostosis. Even~     with successful surgery, children can experience developmental and learning disabilities or~     vision problems. Most often, CS appears as isolated nonsyndromic CS (NSC). Of the several~     subtypes of CS, unilateral or bilateral fusion of the coronal suture is the second most~     common form of CS accounting for 20-30% of all NSC cases. The etiology of coronal NSC (cNSC)~     is not well understood, although the published literature suggests that it is a~     multifactorial condition. About 5-14% of coronal craniosynostosis patients have a positive~     family history, with a specific genetic etiology identified in >25% of cNSC cases, suggesting~     a strong genetic component in the pathogenesis of this birth defect. The causes for cNSC and~     its phenotypic heterogeneity remain largely unknown. An international team of investigators~     will generate large genomic and gene expression datasets on samples from patients with cNSC.~     State-of-the-art imaging, genetic, and developmental and systems biology approaches will be~     used to quantitatively model novel pathways and networks involved in the development of cNSC.~     Novel variant-, gene- and network-level analyses will be performed on the genomic data~     obtained from cNSC cases, their relatives, and controls to identify novel variants and~     genetic regions associated with cNCS. Quantitative, analytical, and functional validations of~     these predictions will provide insights into the etiology and possible therapeutic targets~     for CS and potentially other bone-related disorders.~   "
41330|NCT03025750|"~     The trial is a phase III, non-inferiority, observer-blind, randomised, active controlled,~     multicentre clinical trial with 2 parallel groups: IPV-Al SSI (investigational vaccine) and~     IPV SSI (comparator vaccine). The vaccines will be administered at 2, 4 and 6 months of age.~   "
41331|NCT03025737|"~     The aim of the present proposal is to investigate the development of distinct morphological,~     functional, biochemical and molecular aspects of short- and long-term sport-induced changes~     in the heart, to get a better understanding on the (patho)physiology of athlete's heart. The~     main goal of our research is to deepen our knowledge on the proper differentiation between~     beneficial (physiological) and harmful (pathological) consequences of professional sport,~     thereby effectively preventing potential cardiovascular complications of athletes.~   "
41332|NCT03025724|"~     This pilot study will evaluate the effectiveness of using photodynamic therapy for treatment~     of cutaneous squamous cell in situ (SCCis). Our hypothesis is that PDT will be effective for~     treating SCCis. This study will also secondarily evaluate the tolerability of using~     photodynamic therapy for treatment of SCCis.~      Investigators plan to enroll 40 subjects with biopsy proven SCCis. Exclusion criteria include~     lesion in high-risk site (head, neck, hands, feet), previous severe adverse reaction to~     topical 20% aminolevulinic acid (Kerastick), previous severe adverse reaction to blue light~     (BLU-U), allergy to Tegaderm, primary or secondary immunosuppression, history of > 6 skin~     cancers in the past year, photosensitizing condition such as lupus, or sensitivity to~     porphyrins.~      Age, gender, size, and location of the SCCis will be recorded. All subjects will receive~     surgical treatment of their SCCis. The control group will undergo a surgical excision of the~     tumor. After the excision, subjects will be asked to fill out a satisfaction survey. The~     intervention group will receive PDT plus surgical treatment. Photographs of the lesion will~     be taken at each study visit. Subjects in the intervention group will then undergo the study~     procedure of application of topical 20% 5-ALA (Levulan Kerastick; DUSA Pharmaceuticals) to~     the SCCis. At 3-5 weeks after the initial treatment, the subject will repeat the 3-hour ALA~     incubation and blue light exposure. At 6 months after the last treatment, subjects in the~     intervention group will return for clinical follow-up and surgical excision of the lesion.~     After excision, the specimen will be sent for processing by pathology and subjects will be~     asked to fill out a satisfaction visual analog scale. All slides will be read by a~     board-certified dermatopathologist. Side effects will also be monitored using the same graded~     scale described previously. Mild adverse events that have been associated with PDT, including~     erythema, skin crusting, superficial blistering, hypopigmentation, and hyperpigmentation.~     These reactions usually occur during or immediately after the PDT treatment.~   "
41333|NCT03025711|"~     The overall study objective is to evaluate the effectiveness and safety of Trastuzumab~     emtansine (T-DM1) and Pertuzumab under real-world disease conditions in the Spain, and~     specifically in patients treated under compassionate use or early access program~   "
41334|NCT03025698|"~     This is a phase II, open label, multi-center, intra-patient dose escalation study to~     characterize the pharmacokinetics after oral administration of eltrombopag in combination~     with immunosuppressive therapy in pediatric patients with previously untreated or~     relapsed/refractory severe aplastic anemia or recurrent aplastic anemia.~      All patients will be treated with eltrombopag for the 26-week Treatment Period, followed by a~     52-week Follow-Up Period. Patients who have been previously untreated with immunosuppressive~     therapy will be treated according to the standard of care, hATG/cyclosporine, in addition to~     eltrombopag. Patients with relapsed/refractory SAA or recurrent AA will be enrolled into one~     of two treatment options: hATG/cyclosporine plus eltrombopag or cyclosporine plus~     eltrombopag, depending on prior treatment with immunosuppressive therapy.~      After initiating treatment with eltrombopag, patients will have their dose assessed and~     modified as tolerated, until the targeted platelet count or maximum dose is achieved.~     Pharmacokinetic assessments will be performed at time points intended to capture steady state~     PK of the starting dose and highest dose achieved.~      Upon completion of the Treatment and Follow-Up Periods, all patients will be offered the~     opportunity to enroll in an additional 3 year Long Term Follow-Up Period.~   "
41335|NCT03025685|"~     Adequate support is required for challenging percutaneous coronary interventions (PCI). The~     TransRadial Ultra Support Technique (TRUST technique) is a new support technique that~     provides active support by deep pass of the coronary wire into the heart cavities (left~     ventricle-LV, right ventricle-RV) or aorta.~   "
41349|NCT03025503|"~     This study will examine the use of nipple stimulation for cervical ripening in women who~     present to the labor and delivery ward after their water has broken but have a~     contraindication to prostaglandins.~   "
41480|NCT03023774|"~     Evaluate the effectiveness of granulocyte colony-stimulating factor (GCSF) in the treatment~     of thin endometrium or in women with recurrent implantation failure in ICSI cycles~   "
41336|NCT03025672|"~     Clostridium difficile is the first cause of nosocomial infectious diarrhea, due to its mode~     of transmission and its resistance in the environment.~      Nosocomiality is defined by the apparition of an infection 48 hours after the patient's~     hospitalization. Clostridium difficile contamination occurs oro-fecally and is transmitted~     directly through the hand or from the contaminated environment (during care or not). By~     implementing prevention and optimal treatment, nosocomial infections are preventable.~      A clostridium difficile infection causes an additional cost of patient care for the hospital.~     This additional cost is principally due to the increase of the length of the stay. It varies~     according to patient risk factors,and also according to the reason of the hospitalization and~     can vary from 300 euros (~317$) to more than 25.000 euros (26.460$).~      By determining the increase in the length of the stay and the additional cost due to a~     clostridium difficile infection in the GHICL (Groupement des Hôpitaux de l'Institut~     Catholique de Lille), prevention will be valued and measures against those infections should~     be easier to set up.~      The main objective of this study is to evaluate the additional cost of an infection by~     clostridium difficile.~   "
41337|NCT03025659|"~     This is a single-center, observational study. Investigators aim to characterize the~     metabolism of lactate in children over the first forty-eight hours following cardiac surgery.~     Blood samples will be obtained up to 12 timepoints. Samples will be analyzed for~     concentration of pyruvate. Results will be compared to standard of care laboratory results~     for lactate and other direct and indirect measures of cardiac output.~   "
41338|NCT03025646|"~     Background (brief):~      The global burden of depression accounts for 2.5% of global DALYs, and in South Asia the~     estimate is 13.3 % of DALYs per 100,000 populations. Mothers of children with Autism Spectrum~     Disorder (ASD) have reported higher level of depression than mothers of children with other~     developmental disorder and the prevalence of ASD is high in Asian countries. In Bangladesh~     16% of adults suffer from depression and a recent study conducted in Bangladesh has~     documented a high prevalence of depression among mothers of children with ASD (45%). Mothers~     are the life time care givers of children with ASD, and a high burden of depression is likely~     negatively impact on the ability of the mothers to provide care to children at home. Mental~     health is not addressed in Bangladesh and there is scarcity of qualified providers.~      Objectives:~      The investigators propose to pilot the feasibility of a package intervention including~     implementation of mental health care and home based training program for the mothers of~     children with ASD integrated in the regular activities of the special schools that offer ASD~     care in Dhaka city in Bangladesh.~      Methods:~      The study will be conducted in 2 selected special schools over 15 months. In the first stage,~     the investigators will set up the study in two schools and identify various stakeholders for~     qualitative assessment of the barriers of implementing the intervention at the institutional~     level, individual level, family level, provider level, policy maker level and at the level of~     the state. Research staff will identify mothers 18 years of age or older who has a child with~     ASD between 3 and 17 years of age enrolled in the school. Following consent, data collector~     will obtain data and assess current major depressive episode (MDE) of the eligible mothers~     following a standard diagnostic tool (SCID-I). All mothers diagnosed as having MDE will be~     invited to participate in the intervention (intervention mothers) and the investigators will~     assess the performances in children with ASD by applying ASD Diagnostic Check-list (ADCL).~      In the second stage, investigators will implement interventions over 4-6 months, including~     (a) implementing mental health care services at the selected schools targeting the~     intervention mothers, and (b) organizing training sessions of the intervention mothers for~     supporting child care at home for enhancing child performances. Every month a psychiatrist~     will visit each school for providing necessary advice and treatment to the intervention~     mothers or suggest referral to hospital care, if necessary.~      One special educator will be deployed at each school who will organize structured training~     sessions for educating the intervention mothers by using BCC materials developed and~     validated by icddr,b in the local setting. The special educators will conduct multiple group~     sessions including 5-8 mothers in each group for covering the 6 modules over 2 weeks time,~     and follow up intervention mothers at home every month for conducting refresher's training,~     documenting the need of additional training supports, and linking mother with an ASD expert~     for helping mothers taking a decision.~      In stage 3, investigators will conduct post intervention qualitative survey with various~     stakeholders who would be involved with implementing the intervention and participated in the~     baseline qualitative survey. End line assessment will be conducted of current major~     depressive episode (MDE) among all mothers and assess the performance of the children of~     intervention mothers in order to assess the impact of the training at home.~      Outcome measures/variables:~      The primary outcome of the study is to assess the feasibility of institutionalizing the~     combined intervention of mental health care supports and the home based training program of~     the mothers who would be diagnosed as having major current major depressive episode. The~     primary outcome will be assessed by obtaining the perspectives of various stakeholders. The~     following parameters will be assessed for measuring feasibility of the proposed intervention.~      Acceptability, Adaptability, Demands, Practicality, Implementation, Integration~      The secondary outcomes will include estimating the impact of the combined interventions on~     the prevalence rate of maternal depression (MDE), individual performances of children, and~     cost of intervention. Adaptation of the proposed strategy, if feasible will help the mothers~     of children with ASD become skilled workforces for filling in the gap of the special~     educators in resource poor settings, and extension of these services to more children with~     ASD.~   "
41339|NCT03025633|"~     Radiotherapy uses high doses of x-rays directed at tumours to kill them, an unfortunate side~     effect is healthy surrounding tissue will receive some of the x-ray dose and is damaged.~     Approximately 22% of radiotherapy patients receive treatment to cure prostate cancer. The~     technique used requires patients to maintain full bladder and empty bowel because they are~     next to the prostate, the aim of radiotherapy planning is to minimise the radiation dose~     received to healthy organs and tissues as this will reduce side effects. PEARL is commercial~     interactive PC software that shows realistic and functional 3D models of Linac's (machines~     that deliver radiotherapy treatment). Using PEARL it's possible to display realistic patient~     treatments including how an individual would be laid on a treatment couch and how the machine~     will move and sound during treatment. Additionally PEARL provides the opportunity to look~     inside the body to view internal anatomy and show where the radiotherapy treatment is~     directed.~      Information prior to treatment in radiotherapy is normally given verbally one to one. The~     investigators believe this information can be more easily understood if PEARL is used in~     conjunction with this verbal exchange. PEARL gives visual and audio representation of the~     treatment experience, and demonstrates the reasons behind required preparations.~      Research aim is to demonstrate patients who receive information using PEARL have greater~     understanding, reduced anxiety and reduced radiation dose. This will be tested using two~     groups of patients receiving radiotherapy to the prostate. Group A - Verbal information,~     Group B - Verbal information and PEARL demonstration. Data collection is via patient~     questionnaires and review of Cone Beam Computer Tomography (CBCT) images that are taken prior~     to each radiotherapy treatment as standard practice. CBCT's are used to locate the treatment~     area and assess bladder and bowel status and ensure all of these are suitable to deliver~     treatment accurately.~   "
41340|NCT03025620|"~     The purpose of this study is to evaluate the antiatherogenic and anti-inflammatory potential~     of an adequate intake of alpha-linolenic acid in elderly.~   "
41341|NCT03025607|"~     Type 2 diabetes mellitus (T2DM) can be prevented through weight loss and increased physical~     activity, yet its prevalence continues to rise. This trend may be due in part to low rates of~     participation in evidence-based lifestyle change programs such as the Diabetes Prevention~     Program (DPP). New strategies are needed to promote healthy behaviors among individuals at~     risk for T2DM, and mobile health technologies may be an effective and scalable approach to~     achieve this. One promising tool is JOOL Health, a mobile phone-based application that~     leverages principles from Self-Determination Theory to help individuals understand how~     certain behaviors (e.g. sleep, diet, physical activity) influence their ability to pursue~     their core values and purpose in life. Through personalized messaging and feedback, JOOL~     Health aims to increase autonomous motivation, a form of motivation closely associated with~     the initiation and maintenance of healthy behaviors.~      In this mixed methods pilot randomized controlled trial, the investigators will test whether~     the JOOL Health mobile phone-based application -- used alone and in conjunction with other~     mobile health technologies to track weight and physical activity -- can increase autonomous~     motivation to prevent type 2 diabetes mellitus (T2DM) among individuals with prediabetes who~     previously declined participation in a Diabetes Prevention Program (DPP).~   "
41342|NCT03025594|"~     The aim of this study is to demostrate the eficcacy in pain control management after total~     knee arthroplasty of Gonyautoxin. Local administration during surgery of Gonyautoxin before~     wound closure can achieved better pain control and lower morphin use during hospital stay~     compared to local administration of chirocaine, ketorolac and epinephrine~   "
41343|NCT03025581|"~     Premature Rupture of Membranes (PROM) is defined as the rupture of membranes before the onset~     of regular uterine contractions.~      PROM occurs in approximately 10% of all pregnancies (ranging from 2.7% to 17%), with 60% to~     80% of cases occurring at term. Approximately 90% of patients' experience PROM enter~     spontaneous labor within 24 hours, but disagreement exists among health care providers on the~     optimal management of women with PROM, particularly the need for and timing of inductions.~      Nipple stimulation is a non-medical natural method for induction of labor. Previous studies~     demonstrated its effectiveness for initiating labor within 72 hours in women with favorable~     cervices. The actual mechanism by which such a technique results in cervical ripening is not~     well understood.~      In this study, we aim to assess the effectiveness of nipple stimulation in gravid women with~     term PROM choosing expectant management.~   "
41344|NCT03025568|"~     Evaluation of the retention of upper removable partial denture constructed from two different~     flexible thermoplastic materials.(BRE-FLEX and PEEK).~   "
41345|NCT03025555|"~     Evaluation the patient satisfaction and dimensional stability of upper removable partial~     denture constructed from two different flexible thermoplastic materials.(BRE-FLEX and PEEK).~   "
41346|NCT03025542|"~     This is a Phase 2a, multicenter, randomized, subject-blind, investigator-blind, study to~     investigate the pharmacokinetics (PK), pharmacodynamics (PD), and safety of bimekizumab in~     adult subjects with moderate to severe chronic plaque psoriasis~   "
41347|NCT03025529|"~     The main purpose of this study is to see if transcranial magnetic stimulation (TMS) can be~     used to help study brain function in healthy people and in those with neurological diseases~     like essential tremor. This portion of the study is being done to establish the optimal~     methods for stimulating the brain to measure its responses.~   "
41481|NCT03023761|"~     In this clinical trial investigators aimed to evaluate Post endodontic re-treatment pain~     after irradiation of low level laser therapy~   "
41352|NCT03025464|"~     Obstructive sleep apnea (OSA) is the most common type of sleep apnea. The marketplace~     currently does not have an affordable, easy-to-use, over-the-counter, home-based OSA~     screening device. An affordable, available, FDA-approved and easy-to-use over-the-counter OSA~     screening tool would allow greater screening of at-risk individuals, especially in~     underserved communities with low socioeconomic status, hopefully encouraging a greater~     proportion of such individuals to seek treatment for their condition. Over the past year,~     this investigative team has engineered a small screening device (Zerify®) for OSA and~     obtained preliminary evidence of its efficacy in a clinical population under a~     NIMHD-sponsored Phase I STTR award. Phase I Specific Aims 1 and 2 focused on developing a~     small (1.5 x 2.5 x 0.2 inches) semiconductor sensor that could store sound/motion data,~     transfer these data to a computer, and detect non-clinical simulated apnea events with a~     specificity and specificity exceeding 90%. Phase I Specific Aim 3 established the preliminary~     psychometric performance data of the screening device in a clinical sample of 52 patients~     (13% African American, 6% Asian, 4% Mixed or Other Race) against gold-standard~     polysomnography. Phase II proposal aims to optimize the engineered hardware and associated~     OSA algorithms, create a patient companion app and wireless healthcare provider dashboard,~     and compare the efficacy of this screening device to the most commonly utilized sleep apnea~     screener, the home sleep apnea test (HSAT).~   "
41353|NCT03025451|"~     Data from participants in Athens CHIP classes from May 2011 to present will be analyzed to~     evaluate the differences in outcomes based on: 1) gender, 2) age, 3) whether a household~     member participated in the class with them.~      Participants had health screens before and after completing the class. The data from the~     health screens that will be utilized for comparison will include: body mass index (BMI),~     blood pressure, and fasting blood sugar and lipid levels.~   "
41354|NCT03025438|"~     Cytological diagnosis of hepatic angiosarcoma by fine-needle aspiration (FNA) or imprint~     cytology is difficult due not only to its various cytomorphologic features but also clinical~     rarity. Vasoformative features, such as pseudo-acini, branching pseudo-capillary structure,~     and intracytoplasmic lumina, are clues to achieve the diagnosis. But these features are not~     always present. In order to find clues for cytological diagnosis of angiosarcoma, we~     collected cases of hepatic angiosarcoma to study their cytological features. And then~     compared these features with those in their histopathological biopsy or resection.~   "
41355|NCT03025425|"~     An uncontrolled feasibility study on using mouth piece ventilation in palliation of dyspnea~     in subjects with acute exacerbation of COPD without acute hypercapnic respiratory failure.~     Subjects are recruited from the local respiratory ward. The main outcomes are the compliance~     of the subjects with the treatment and alleviation of dyspnea during the treatment period.~   "
41356|NCT03025412|"~     Exercise is a preferred treatment modality for mid-portion achilles tendinopathy. Despite~     this, as many as 44 % of achilles tendinopathy patients do not respond to exercise treatment.~      Surgery for midportion achilles tendinopathy has for many years been done as an open~     procedure. New knowledge resulted in a variety of minimally invasive procedures and the~     development of endoscopic surgery.~      In this study, the effect of non-open surgery and conservative treatment (physiotherapy and~     exercises) will be compared.~   "
41357|NCT03025399|"~     This study include 384 Participants with diabetic non-proliferative retinopathy~      Design Method: Randomized, double blind, placebo controlled and multicenter clinical study.~     Participants treatment for 48 weeks, and main aimed to evaluate the therapeutic effect of~     tang wang prescription improve degree of retinal microvascular disease of patients with~     diabetic non-proliferative retinopathy.~   "
41358|NCT03025386|"~     A cochlear implant is a device for the rehabilitation of severe to profound hearing loss.~     Despite the standardization of surgical procedures and rehabilitation, speech discrimination~     performance varied significantly in cochlear implant users and could be improved by early~     individualized cares. However, there is no objective method yet to evaluate phonemes~     discrimination, especially in infants, which account for more than half of the indications~     for implantation. In electroencephalography (EEG), it is possible to highlight the~     discrimination of auditory stimuli studying the wave of MisMatch Negativity (MMN). In this~     work, this study propose to use the MMN as an objective vocal audiometry method to evaluate~     the ability to discriminate phonemes, the smallest units of oral language, in adult cochlear~     implant users.~   "
41359|NCT03025373|"~     An observational study will be conducted in the ICU (Intensive care unit) including patients~     with heart surgery (< 5 days) and prolonged ICU stay (> 5 days). Patients will receive 5 min~     Virtual reality stimulation per day. A modified version of the Oculus Rift VR glasses~     (Facebook inc., USA) with stereoscopic vision and stereo sound will be used to present the~     virtual world to patients. An integrated eye tracker will measure oculomotor responses that~     will be synchronized with the physiological data recording. All participants will undergo~     neuropsychological testing after ICU stay, and after a three-months follow-up. Quality of~     life prior to the ICU stay will be enquired from relatives. Main outcome variable is the~     explorative behaviour (attention). Secondary outcomes are the quality of life and cognitive~     functioning.~   "
41360|NCT03025360|"~     Larotrectinib (LOXO-101) expanded access is for patients with cancer with a NTRK1, NTRK2, or~     NTRK3 gene fusion who are ineligible for an ongoing larotrectinib (LOXO-101) clinical trial~     or have other considerations that prevent access to larotrectinib (LOXO-101) through an~     existing clinical trial. Expanded access is intended to treat individual patients with~     different types of cancers with a NTRK gene fusion.~   "
41361|NCT03025347|"~     Using a database of individuals with FTO genetic data, the study aims to assess the appetite,~     energy intake and gut hormone responses to a bout of moderate- to high intensity exercise in~     individuals with genetic variations in the FTO gene.~   "
41394|NCT03024905|"~     The purpose of this trial is to establish if several interventions will help women in rural~     Tanzania access health care services during pregnancy and at the time of delivery. The~     interventions include education about the importance of attending antenatal care visits with~     nurses and facility deliveries, a voucher for transport to access the health facility at the~     time of delivery, and supplies to be used either at the health facility, or on route if the~     women does not make it to the health facility.~   "
41494|NCT03023592|"~     A single-center, self-control, open-label study of efficacy and safety of Iguratimod in~     patients with Sjögren's Syndrome~   "
41362|NCT03025334|"~     Parkinson's disease (PD) has been classically regarded as a movement disorder, so earlier~     work has focused on treating motor symptoms only. As PD patients now have longer life~     expectancy, the relatively slowly progressing cognitive deficits (compared to their motor~     deficits) have become one of the major challenges. Approximately 80% of PD patients~     eventually become demented. Therefore cognitive dysfunction is one of the most significant~     factors affecting the quality of life of patients with PD. While dementia in Parkinson's~     disease is routinely treated by cholinesterase inhibitors (e.g., donepezil and rivastigmine),~     their efficacy on mild cognitive impairment found in non-demented PD is questionable.~     Alternative approaches have been proposed including transcranial direct current stimulation~     (tDCS) but no consensus has been reached. This can be attributed mainly to: (1) imprecise~     knowledge of the underlying functional circuitry mediating this disease manifestation and (2)~     inter-individual variability. Here, the investigators will utilize a novel personalized~     network analysis approach to elucidate on the underlying mechanisms of the effect of tDCS on~     cognitive dysfunction in non-demented PD patients.~      It has been well documented that the caudate nucleus plays an important role in cognitive~     dysfunction found in PD. In the investigators' preliminary resting-state functional magnetic~     resonance imaging (fMRI) study, they have shown that the connectivity of the right caudate~     nucleus is correlated to cognitive status of PD patients measured by the Montreal Cognitive~     Assessment (MoCA). The investigators hypothesize that tDCS on the left and/or right~     dorsolateral prefrontal cortex may restore the functional connectivity of the right caudate~     nucleus which may in turn improve patients' cognitive performance.~   "
41363|NCT03025321|"~     Repetitive bilateral (left cathodal/ right anodal) transcranial Direct Current Stimulation~     (tDCS) over the dorsolateral prefrontal cortex (DLPFC) seems to reduce craving and relapse~     risk. However, little is known about the relapse rates in cocaine addiction after tDCS,~     despite the need for new treatment interventions to reduce the high relapse rates in cocaine~     addiction. The investigators aim to explore the effects of repetitive tDCS in a larger sample~     (N=80) of cocaine addicted patients on number of relapse days after three months. In~     addition, the underlying working mechanism will be explored (e.g. cognitive control~     functioning). Ecological momentary assessment (EMA) will be used to measure relapse, craving~     and mood since retrospective self-reports seem to be less reliable in this respect.~   "
41364|NCT03025308|"~     The primary objective of this study is to evaluate the long-term safety and tolerability of~     filgotinib in participants who have completed one of the parent studies of filgotinib in~     rheumatoid arthritis (RA).~   "
41365|NCT03025295|"~     The current study is designed to investigate the difference of plasma orexin A levels between~     Dexmedetomidine group and controlled group at emergence time from total intravenous~     anesthesia who will undergo elective lumbar surgery.~   "
41366|NCT03025282|"~     This is an exploratory, single-centre, investigator blinded, randomized, controlled,~     intra-individual study, involving subjects with psoriasis vulgaris.~      The objective is to evaluate, in a modified Dumas-Scholtz psoriasis mini-zone test, the~     safety and efficacy of CD10367 solution at 1% and 3% after a 3-week treatment period of once~     daily application.~   "
41367|NCT03025269|"~     This is a Phase IV, prospective, open-label, single-center, observational, longitudinal,~     single blinded study. The investigators will examine the effects of Ocrelizumab on cognitive,~     patient reported outcomes (PROs), quality of life (QoL), multiple sclerosis functional~     composite (MSFC), working status and magnetic resonance imaging (MRI) outcomes across 12 and~     24 months.~   "
41368|NCT03025256|"~     This clinical research study consists of 2 phases: dose escalation (Phase 1) and dose~     expansion (Phase 2).~      The goal of Phase 1 of this research study is to find the highest tolerable dose level of~     nivolumab that can be given both by intravenous (IV) infusion and intrathecal (IT) injection~     to patients with leptomeningeal disease (LMD). IV infusions are given by vein, while IT~     injections are given directly into the cerebrospinal fluid (CSF).~      The goal of Phase 2 of this research study is to learn if the highest tolerable dose level~     combination found during Phase 1 can help to control the disease.~      The safety of the drug combination will also be studied in both phases.~      This is an investigational study. Nivolumab is FDA approved and commercially available for~     the treatment of several types of cancer. Its use in LMD is considered investigational. The~     method of injecting nivolumab into the CSF is investigational. The study doctor can explain~     how the study drug is designed to work.~      Up to 30 participants will be enrolled in this study. All will take part at MD Anderson.~   "
41369|NCT03025243|"~     The purpose of this study is to evaluate the effect of printing layer thickness on accuracy~     of computer aided surgical guide~   "
41370|NCT03025230|"~     Hypothesis The application of intramuscular electrostimulation will be more effectiveness~     than the dry needling in myofascial trigger points treatment.~      Objetives:~      To determine the effectiveness of intramuscular electrostimulation in the treatment of~     trigger points of the levator scapula muscle for the improvement of pain in mechanical~     cervicalgia.~      Participants: Subjects with diagnosed of myofascial pain syndrome in cervical region and~     active trigger points in levator scapulae muscle, randomly assigned to experimental or~     control group.~      Intervention: Control group: one session of dry needling in active trigger points;~     experimental group: one session of intramuscular stimulation in active trigger points.~      Main Outcomes Measures: Pain, pressure pain threshold (PPT), active cervical range of motion~     and strength muscle . The measures will be taken before, after and one week after the~     interventions.~   "
41371|NCT03025217|"~     The investigators aim to develop, pilot and evaluate a new Total Lifestyle Coaching (TLC)~     program, that will address both information and behavior-change aspects of nutrition~     education for patients whose body mass index (BMI) exceeds 25.~   "
41408|NCT03024723|"~     The mechanism of Upper airway obstruction (UAO) during anesthesia shares many similarities~     with the upper airway obstruction observed during obstructive sleep apnea (OSA). Nasal~     continuous positive airway pressure (nCPAP) via nasal mask (NM) can maintain the airway~     patent with near 100% success in patients with OSA. Obesity is a major risk factors for~     obstructive sleep apnea and obese patients have a higher prevalence of UAO during anesthesia.~     The investigators hypotheses that nCPAP should eliminate airway obstruction in obese patients~     under anesthesia. The investigators propose to test this hypothesis and determine the~     efficacy of nCPAP on maintaining airway patency in obese patients who require general~     anesthesia compared with CPAP administering face mask.~   "
41372|NCT03025204|"~     Approaches and objectives related to the treatment of patients with aggressive periodontitis~     are not markedly different compared patients with the chronic form. However, the large bone~     loss related to young age in this aggressive form, justify a well-founded strategy, intending~     to further stabilization of disease progression. For this, should make use of regenerative~     therapies in the advanced stages of treatment. Noteworthy is the use of proteins derived from~     the enamel matrix (EMD) in patients with chronic periodontitis, but there is little evidence~     about the effects of this material in aggressive periodontitis. Thus, the present study aims~     to evaluate the use of EMD in patients with aggressive periodontitis, comparing them to~     individuals with chronic periodontitis. Will then be selected 45 subjects, among patients~     with generalized chronic periodontitis (GCP) and generalized aggressive periodontitis (GAP),~     with one or more intra-bony defects in radiographic examination, with a minimum size of 4 mm~     deep and 2 mm horizontal, associated with a probing depth (PD) ≥6mm, to be treated according~     to the groups: GAP+OFD (n = 15) GAP patients which will receive open flap debridement;~     GAP+OFD/EMD (n=15) GAP patients which will receive open flap debridement and application of~     EMD; GCP+OFD/EMD (n=15) GCP patients which will receive open flap debridement and application~     of EMD. Clinical evaluations will be performed at baseline, 3, 6 months and 1 year after. At~     baseline, 7, 15, 45 days, 3, 6 months and 1 year after will be collect samples of gingival~     fluid to detect bone markers by Luminex / MAGpix technology. For the periods baseline, 3, 6~     months and 1 year will be collected subgingival biofilm for the detection and quantification~     of periodontal pathogens by real-PCR. Will still be carried x-rays on baseline, 6 months and~     1 year after, and questionnaires about patient satisfaction and perception of therapy at~     baseline, 7 days and 6 months. To compare the parameters evaluated, ANOVA, Tukey, chi-square,~     Spearman and Person tests will be used (α = 5%).~   "
41373|NCT03025191|"~     The purpose of this study is to adapt an existing couples-level HIV prevention intervention~     for community populations (CONNECT I/II; PI: El-Bassel) to enable implementation among~     couples affected by incarceration (PRISON CONNECT) and pilot test its feasibility and~     acceptability among men incarcerated in the Connecticut Department of Correction (CTDOC) and~     their community-dwelling committed female partners.~   "
41374|NCT03025178|"~     We previously performed a study to create formula for the optimal insertion depth of left~     internal jugular vein catheter in infant, which was registered at cris.nih.go.kr. We found~     that two calculation methods using height and the distance between landmarks (0.11 × height~     (cm) + 0.19 and 1.02 × I-A-B (cm) + 1.55, where I was insertion point of needle, A was the~     most prominent point of the sternal head of the left clavicle, and B was the midpoint of the~     perpendicular line drawn between the sternal head of the right clavicle and an imaginary line~     between the nipples) were clinically feasible to determine the insertion depth of left~     internal jugular vein catheter. In this study, we will compare the actual insertion depth~     with the insertion depth determined from above two calculation methods in other 46 infants.~   "
41375|NCT03025165|"~     The purpose of this study is to compare the virological and clinical outcomes of patients~     participating in community models of ART delivery to the standard of care in an urban setting~     in Zambia.~   "
41376|NCT03025152|"~     This trial aims to determine whether Hou Gu Mi Xi is an effective treatment for improving~     symptoms and indicators in patients with spleen qi deficiency and radical gastrectomy for~     gastric cancer.~   "
41377|NCT03025139|"~     This randomized phase III trial studies how well mindfulness meditation or survivorship~     education work in improving behavioral symptoms in younger stage 0-III breast cancer~     survivors. Behavioral interventions, such as mindfulness meditation, use techniques to help~     patients change the way they react to environmental triggers that may cause a negative~     reaction. Survivorship education after treatment may reduce stress and improve the well-being~     and quality of life of patients with breast cancer. Mindfulness meditation or survivorship~     education may help improve the health behaviors of younger breast cancer survivors.~   "
41378|NCT03025126|"~     Congenital or acquired neurological disorders could lead to consistent motor and cognitive~     disabilities. The continuity and persistency of a tailored home rehabilitation protocol after~     recovery is crucial to prevent disease aggravation or relapses. The integration of a~     web-based new technology in home rehabilitation programme can constitute a functional low~     cost resource by offering patients off-line (and on-line) monitoring and by proposing new~     motivating ways of rehabilitation through high tech tools such as serious games.~   "
41379|NCT03025113|"~     The purpose of this study is to evaluate the safety and efficacy of an association with one~     anti-inflammatory and one muscle relaxant agent compared to the one muscle relaxant agent~     isolated in the treatment of osteomuscular pain in adults.~   "
41380|NCT03025100|"~     Guideline directed use of pharmacologic Venous thromboembolism (VTE) prophylaxis emphasizes~     mobility evaluation. Mobility is a key component of risk stratification. Poor mobility~     evaluation by providers may be a significant barrier to appropriate use of VTE prophylaxis.~     The investigators aim is to propose to determine whether level of mobility during~     hospitalization is being used to influence use and duration of VTE prophylaxis among~     medically ill hospitalized elders. To achieve this aim, the investigator will collect~     prospective observational data to objectively measure inpatient mobility using patient~     mounted accelerometers during patient hospital stays.~      The investigator's goal is to improve the appropriateness of use of VTE prophylaxis among~     those in which the risks of harm may outweigh the benefit. Results from this study will~     provide important insights about use of risk assessment, and the relationship between patient~     mobility and VTE prophylaxis. These results are critical to understanding how to take the~     next steps toward improving the appropriate use and safety of anticoagulants in hospitalized~     older adults. Information from this study could be used in future proposals to study~     interventions to ultimately improve hospital practice in the care of older adults.~   "
41381|NCT03025087|"~     The purpose of this study is to determine whether hydroxychloroquine decreases the relative~     leakage of the brain barrier after surgery.~   "
41382|NCT03025074|"~     The purpose of establishing a biorepository is to provide high quality specimens (serum,~     plasma, buffy coat and liver tissue) for future researchers who are studying the effects that~     fatty liver and viral diseases have on the liver.~   "
41420|NCT03024567|"~     To perform a randomized, double-blind clinical study on the effects of an increased salt~     intake on metabolic, cardiovascular and immunological parameters and the gut microbiota~   "
41421|NCT03024554|"~     To determine the safety and efficacy of the BMFM® kit in the use for the endovascular~     treatment of aortic aneurysms involving iliac arteries. The BMFM® kit is an adaptation of the~     aortic MFM® to the aortoiliac bifurcation morphology. It should be noted that the aortic MFM®~     has CE mark approval for the aortic aneurysm treatment.~   "
41530|NCT03023124|"~     Phase II randomized study for the comparison of trabectedin versus doxorubicin plus~     dacarbazine in patients with advanced solitary fibrous tumor~   "
41383|NCT03025061|"~     Within-day and Between-day Repeatability of the Breath Pattern in Healthy Children and in~     Children With Moderate or Severe Asthma is an observational prospective study in outpatient~     clinic of Pediatric Allergology & Pulmonology (PAP) within the Institute of Biomedicine and~     Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (IBIM CNR),~     Italy.~      The electronic nose (E-nose) has been proposed as a novel, non-invasive tool to evaluate the~     level of airway inflammation for different respiratory diseases, especially in children. To~     date, there are no data on the within-day and the between-day repeatability of the breath~     pattern in healthy children and in children with moderate or severe asthma.~      The breath pattern will be analyzed by collecting, for each child, three samples of the~     breath through the E-nose. Within-day repeatability will be assessed using two consecutive~     measurements (the second one after 30 minutes). Between-day repeatability will be assessed~     using a third measurement repeated after 7 days.~      The study is expected to provide information about the accuracy of E-nose measurements for a~     child population.~   "
41384|NCT03025048|"~     People with spinal cord injury are at increased risk for overweight and obesity, type 2~     diabetes, cardiovascular disease and decreased quality of life compared With able bodied.~      This pilot aims to assess the impact of a nutrition intervention that combines several~     methods to help people change their lifestyle.~      The pilot project combines individual interviews and personal lifestyle goals (diet) with~     group classes for people with long-standing spinal cord injury.~      In addition to nutrition theory and practical exercises for diet-planning, motivational~     interviewing and mindfullness are incorporated into the course. The course is~     interdisciplinary, but is led primarily by a dietitian. Data is collected before the course~     starts and right after the 9-week course ends. The measurements involves self-perceived~     quality of life, food diary, weight, waist circumference and body composition (measured by~     BIA and DXA).~   "
41385|NCT03025035|"~     This trial will evaluate the use of immunotherapy in a population with incurable advanced~     breast cancer associated with a germline BRCA mutation. The main objective is to examine~     overall response rate of pembrolizumab (immunotherapy) single agent therapy in advanced~     BRCA-mutated breast cancer.~   "
41386|NCT03025022|"~     The objective of this study is to evaluate the absorption, distribution, metabolism, and~     excretion (ADME) of 14C-JNJ-42847922 in healthy subjects after a single oral dose of 40~     milligram (mg) 14C-JNJ-42847922 containing maximally 100 MicroCurie. Safety and tolerability~     will also be assessed.~   "
41387|NCT03025009|"~     The main purpose of this study is to investigate the side effects related to LY3192767 when~     given as an injection under the skin to healthy participants. Blood tests will be done to~     check how much LY3192767 is absorbed into the bloodstream, how long it takes for the body to~     get rid of it, and how it affects blood sugar levels. The study has two parts: Part A and~     Part B. Each participant will enroll in one part. For each participant, Part A will last up~     to about 32 days after last dose and Part B will last up to about 49 days after last dose.~     Screening must be completed prior to study start.~   "
41388|NCT03024996|"~     This is a Phase III, multicenter, randomized, placebo-controlled, double-blind study to~     evaluate the efficacy and safety of atezolizumab versus placebo in participants with RCC who~     are at high risk of disease recurrence following nephrectomy.~   "
41389|NCT03024983|"~     Carbohydrate-based products can influence the post-prandial glycemic response differently~     based on their ability to be digested, absorbed and to affect rises in plasma glucose. Pasta~     is one of the major carbohydrate-rich foods consumed in Italy. Studies from the literature~     describe a lower glycemic response after the consumption of pasta compared with other~     wheat-based products, such as bread. Among the factors affecting post-prandial glycemia after~     consumption of carbohydrate-based products, the technological process represents a central~     one.In fact, the different technological processes alter the food matrix which can affect the~     post-prandial metabolism of glucose differently. Thus, the present study aims at~     investigating the effect induced by the principal steps of the process of pasta production on~     the reduction of post-prandial glycemic response (post-prandial glucose, insulin, GLP-1, GIP~     plasma concentrations).~   "
41390|NCT03024957|"~     this work aims to investigate the effect of intrathecal administration of Morphine,~     Dexmedetomidine or both in combination on cellular immunity and cytokine production in~     patients undergoing major abdominal cancer surgeries.~   "
41391|NCT03024944|"~     The purpose of this project is to study brain imaging of a substance called tau, which is~     found in brains of persons with Alzheimer's disease, using the Tau binder, 18F-THK-5351, for~     live imaging of tau in the brain. The main goal of this proposal is to study whether diabetes~     status (type 2 diabetes [referred to as diabetes] and pre-diabetes, compared with normal~     glucose tolerance [NGT]), is associated with increased tau accumulation in the brain, one of~     the culprits of Alzheimer's disease, in a community-based group of middle aged~     Caribbean-Hispanics with a mean age of 63 years. The investigators propose to conduct tau~     positron emission tomography (PET) imaging in 30 middle aged Hispanics.~   "
41392|NCT03024931|"~     Severe burn patients are some of the most challenging critically ill patients with an extreme~     and continuous state of physiological stress. Patients tends to stay for a long period of~     time in intensive care unit to treat burns as well as dealing with complications that arises~     from the initial burns injury. Severe burns patients are notoriously known to loose weight.~     The word 'catabolism' is used medically. This theory of catabolism after a trauma was~     hypothesised in 1942 by Professor Curthberston and based on animal models. Since this date,~     despite medical technological advancement, there has been no research that confirms Professor~     Curthberston's theory. Investigators still do not know the exact mechanism by which the body~     changes from conserving energy to becoming catabolic. Furthermore, it remains unclear whether~     this change in catabolism is necessary to heal from burns injury.~      This theoretical catabolism in burns patients is currently treated with nutritional~     supplement, use of medications including beta-blockers (suppresses heart rate and decreases~     blood pressure) and oxandrolone (formula which is similar to testosterone to build up~     muscles).~      There are evidences to suggest that increase in weight loss worsens the outcome in burns~     injury. Both overfeeding or underfeeding patients can be detrimental. In this research, the~     exact changes in metabolic rate will be measured in the first 72 hours of the study using a~     calorimetry machine. In addition to the metabolic rate, the response to the heart, liver,~     kidneys and hormonal levels will be measured. By looking into these dynamic changes the~     investigator will be able to elucidate whether there is a real increase in metabolic rate. If~     there is, the investigator would also be able to tell the response of different organs and~     whether there are any hormones that could be responsible to inflicting the metabolic changes.~   "
41393|NCT03024918|"~     This is an observational study in 3 cohorts of monochorionic diamniotic (MCDA) twins. The aim~     of the study is to assess whether unequal placental sharing can be predicted in pregnancy and~     whether it is predictive of pregnancy outcome.~   "
41395|NCT03024892|"~     The investigators will collect the pre-operative medical history and arrange physical~     examination, life quality evaluation, blood and biochemical test. The Patients with acute~     cholecytitis, gallstone or gallbladder polyp without interventional treatment or~     cholecystitis after percurtaneus gallbladder drainage(PTGBD) were involved in this study.~     Four laparoscopic ports were introduced and the pneumoperitoneum (12mmHg) was established. In~     study group , ICG was give by intra-gallbladder injection or systemic injection, the~     cholecystectomy were performed . In control group, no ICG was given and traditional~     cholecystectomy were performed. A near-infrared optimized laparoscope was used to detect the~     ICG fluorescence signal arising from gallbladder , cystic duct and common bile duct before~     cholecystectomy in study group. According to the enhancement of ICG, the cholecystectomy was~     started from cystic duct in Calot's triangle.Time to gallbladder removed was recorded.~     Conversion rate, post-operative morbidity and mortality will be recorded as well .~   "
41396|NCT03024879|"~     In this study, the investigators aimed at evaluating the role of motilin in the regulation of~     food intake. Motilin, a gastrointestinal hormone, is a hunger signal in healthy volunteers~     and is significantly increased in obese patients. Its role in food intake regulation might~     contribute to the pathogenesis of obesity.~   "
41397|NCT03024866|"~     This is a retrospective-prospective study design. Patients who completed treatment~     approximately 3 years (range of 2-4 years) at time of IRB approval of this study will be~     identified and any existing data in the patient's record will be collected in addition to~     conducting office visits for long-term follow-up.~   "
41398|NCT03024853|"~     The aim of this study is to analyze the efficacy of several variations of an already~     validated Positive Psychology Intervention (PPI) called Best Possible Self, using Information~     and Communication Technologies (ICT) in general population. Participants are randomly~     assigned to one of 4 conditions: BPS PAST condition, BPS PRESENT condition, BPS FUTURE~     condition, and CONTROL condition (daily activities).~   "
41399|NCT03024840|"~     To study the effect of different anaesthetic methods on pediatric neurocognitive development~     and cerebral injury during pediatric living related liver transplantation .~   "
41400|NCT03024827|"~     This study will assess the safety and tolerability of a cannabidiol-enriched Cannabis Herbal~     Extract in a small group of children with refractory epileptic encephalopathy. The dosage of~     Cannabis Herbal Extract will be gradually increased over a four month time period.~   "
41401|NCT03024814|"~     The purpose of this study is to determine whether acetaminophen is effective in prevention or~     reducing the severity of IVH in premature infants.~   "
41402|NCT03024801|"~     To analyze the effectiveness of intra-articular injection of autologous PRP on knee cartilage~     repair and evaluating functional recovery of the knee joint in knee cartilage injury~     patients.~   "
41403|NCT03024788|"~     Study of the correlation between AGEsP and HbA1c and diabetic retinopathy prevalence:~     determination of cut-off value of AGEsP and HbA1c in type 2 diabetes diagnosis in China~   "
41404|NCT03024775|"~     Non-celiac gluten sensitivity (NCGS) is a condition where intestinal and extraintestinal~     symptoms are triggered by gluten ingestion in the absence of celiac disease and wheat~     allergy. Despite the great interest in NCGS, much remains unknown about the pathogenesis.~     Some studies seem to suggest that wheat components other than gluten (i.e. amylase/trypsine~     inhibitors, ATIs) can cause the symptoms, and therefore the term non-celiac wheat~     sensitivity (NCWS) has been proposed instead of NCGS. It is believed that this condition is~     worldwide increasing, due to the evolution of wheat breeding (i.e. consumption of wheats with~     high gluten content), and that ancient wheats are better tolerated by NCWS patients than the~     modern ones. Therefore, the aim of the study is to determine whether the common belief~     regarding the fact that ancient wheats are better tolerated by NCWS patients than the modern~     ones is confirmed by scientific data, and to identify the wheat kernel components triggering~     this pathology. The availability of wheat materials with opposite characteristics, such as~     the period of development (ancient vs. modern), or the technological properties (cultivars~     with weak glutens vs. strong gluten), or the presence/absence of specific ATIs polypeptides,~     will allow to define the role played by these factors. Therefore, the study has two~     objectives: 1) extraction and testing of total kernel proteins, in order to evaluate the~     inflammatory response to gluten and non-gluten proteins by peripheral blood mononuclear cells~     (PBMC) and immunocytes extracted by the rectal mucosa of NCWS patients and healthy control~     subjects, and 2) clinically testing two wheat genotypes, selected on the basis of the~     previous in vitro studies, showing the highest and the lowest in vitro inflammatory response,~     in order to verify their effect in triggering NCWS symptoms.~   "
41405|NCT03024762|"~     The Active Search for Pediatric HIV/AIDS (ASPA) aims at assessing the acceptability,~     feasibility and effectiveness of the targeted provider-initiated-testing and counseling~     (tPITC) in comparison with the blanket provider-initiated-testing and counseling (bPITC)~     among children and adolescents in Cameroon. The new knowledge generated will inform~     programming of more suitable strategies to identify HIV-infected children and adolescents and~     this will contribute to reducing the current global gap in HIV treatment among this~     subpopulation group.~   "
41406|NCT03024749|"~     Spinal arteriovenous fistulas (AVFs) and arteriovenous malformations (AVMs) are complex~     neurosurgical lesions that are very challenging to manage. Spinal vascular malformations~     account for 3%-4% of all intradural spinal cord mass lesions. Over the last few decades our~     understanding of these lesions has dramatically increased thanks to neuroimaging technology~     (e.g. spinal angiography and indocyanine green angiography). Various treatment modalities~     including conservative observation, endovascular embolization, microsurgical resection,~     radiation therapy, and combined therapies have been reported. The treatment for these AVMs~     and AVFs depends on their location, the type of malformation, the area of the spine involved,~     and the condition of the patient at the time of treatment. Due to the rarity of these spinal~     vascular lesions, reports of their management and outcomes have been limited to small series~     and case reports. And the rates of obliteration and outcomes are not satisfactory, especially~     the spinal AVMs. Spinal vascular lesions are rare but represent a formidable challenge for~     the treating neurosurgeon.The purpose of this study is to establish multimodality treatment~     mode and evaluate the anatomical cure rate and functional preservation rate.~   "
41407|NCT03024736|"~     In this retrospective chart review, the investigators plan to analyze the effects of~     buprenorphine compared to methadone in opioid-maintained pregnant women. The investigators~     will evaluate both maternal and neonatal outcomes, with a primary outcome of infant hospital~     length of stay. The investigators will evaluate patients receiving care in a single setting.~   "
41429|NCT03024450|"~     Trastuzumab plus chemotherapy is an effective therapy in HER2 positive advanced gastric~     cancer (AGC). However, the efficacy of routine trastuzumab therapy and its association with~     clinicopathologic factors remain unclear. The object of the study is to determine whether the~     addition of trastuzumab to first-line chemotherapy improves efficacy compared with~     chemotherapy alone in HER2 positive AGC.~   "
41409|NCT03024710|"~     Infant feeding practices and nutritional status among children is interrelated and link is~     well established. Incidence of malnutrition sharply rises during 6-9 months of age in most of~     the developing countries which coincide with the period of complimentary feeding (CF). This~     prospective randomized trial will be implemented in ongoing health and demographic~     surveillance system of Matlab, ICDDR,B and will be nested into an ongoing maternal and child~     health services area. Area of community health workers (four blocks) will be divided into two~     pairs and each pair will be randomly assigned into intervention or control groups. The~     eligible and consented mother-infant newborn will be recruited either into an intervention or~     control groups based on the areas of the paired block. The mothers and family members of the~     intervention area will receive intensive counseling on complementary feeding practices~     through community health workers. In total about 360 mother-infant pair will be recruited in~     the study for each site. Data on children's anthropometry (weight and lengths), information~     on complementary feeding practices and related covariates will be collected through trained~     research staffs. Data will be evaluated on reduction of burden of malnutrition (stunting,~     underweight, wasting) and complimentary feeding index between intervention and control~     groups.~   "
41410|NCT03024697|"~     In this proposed study, the investigators are looking to conduct a prospective, randomised,~     double-blind, non-inferiority trial, to study single-shot pectoral plane (PECs) blocks versus~     continuous local anaesthetic infusion analgesia versus a combination of PECs blocks and local~     anaesthetic infusion analgesia, when it comes to providing analgesia for most forms of breast~     surgery.~      Breast surgery is common, and the optimal form of analgesia is currently unknown. Techniques~     involving local anaesthetic, such as pectoral plane (PECs) blocks and infusion pumps, are~     growing in popularity, as they reduce the amount of opioid medications used. Opioids are~     associated with nausea, vomiting, low blood pressure, drowsiness and constipation, and as~     such, opioid-sparing analgesic regimens postoperatively are becoming more common. These~     regimens will typically involve paracetamol, a NSAID (non-steroidal anti-inflammatory drug),~     and a local anaesthetic technique.~      Pectoral plane blocks involve a once-off injection of local anaesthetic at two locations~     within the chest wall, typically done after the patient undergoes general anaesthesia, but~     before the commencement of surgery. Local anaesthetic infusion pumps involve the insertion of~     a catheter into the wound at the end of surgery, before the patient emerges from general~     anaesthesia, that constantly emit local anaesthetic over a defined period of time. Each~     technique is considered extremely safe, and is considered acceptable as a form of pain relief~     in patients undergoing breast surgery.~      There are no published works comparing pectoral plane blocks with local anaesthetic infusion~     pump analgesia, and the investigators see a gap in the knowledge base that can be addressed.~     This study will allow efficacy, safety and cost of the three techniques to be compared. The~     investigators feel the study design is robust, and statistical analysis based on previously~     published works in the area of postoperative analgesia has allowed the study to be powered~     appropriately.~      Patients undergoing breast surgery are a vulnerable group, and this is recognised via the~     provision of a comprehensive Patient Information Leaflet and a commitment to respecting the~     process of Informed Consent. The investigators also recognise this is a stressful period in a~     woman's life, and the study will be conducted in a sensitive and compassionate manner.~      The study has been designed to be prospective, randomised, and double-blinded. The~     anaesthetic will be standardised in relation to analgesic and anti-emetic agents~     administered, in order to minimise variables. Chronic post-surgical pain is a growing area of~     research, and the follow-up telephone interview at 3-months will allow investigation of this.~      A Data Record Form will be utilised for data collection, which will subsequently be analysed~     statistically. Data will be handled sensitively, securely, and by the minimum number of~     researchers. A plan is in place for destruction of data at an appropriate time.~      While there will be no direct benefit to participants, including monetary considerations,~     this research study will add to the knowledge-base surrounding analgesia for breast surgery.~   "
41411|NCT03024684|"~     The purpose of this study is to evaluate whether statin could prevent recurrence of~     hepatocellular carcinoma after curative treatment~   "
41412|NCT03024671|"~     The dermatological testing of cosmetic products which are new on the market, or existing~     products with novel formulations is common and a useful procedure, yet necessary to alleviate~     common irritants and contact allergic reactions. Cosmetic products contain a range of~     substances that may be considered as potential irritants or contact allergens. In order to~     estimate that risk, cosmetics are tested by applying patch tests.~   "
41413|NCT03024658|"~     Background: Positive end expiratory pressure (PEEP) at the time of induction increases~     oxygenation by preventing lung atelectasis. However, PEEP may not prove beneficial in all~     cases. Factors affecting the action of PEEP have not been elucidated well and remain~     controversial. Pulmonary vasculature has direct bearing on the action of PEEP as has been~     proven in previous studies. Thus this study was planned to evaluate the action of PEEP on the~     basis of pulmonary artery systolic pressure (PASP) which is non invasive and easily measured~     by trans-thoracic echocardiography.~      Methodology: This Randomized prospective study comprised of 70 morbidly obese patients, ASA~     grade II or III, aged 20-65 years with BMI > 40kg/m2, scheduled for elective laparoscopic~     bariatric surgery. Ten patients had to be excluded. Thus a total of 60 patients participated~     in the study. Thirty patients received no PEEP at the time of induction while other 30~     patients were given a PEEP of 10cm of H2O. Serial ABG samples were taken pre operatively, at~     the time of intubation, 5 min after intubation and 10 min after intubation. Patients were~     then divided into four groups on the basis of PASP value of ≤ 30 mm Hg with and without PEEP~     or > 30 mm Hg~   "
41414|NCT03024645|"~     The main goal of the research is to apply and evaluate the web-based preventive intervention~     (the Be a Mom program), in terms of its efficacy, acceptability and feasibility (user's~     adherence, dropout), and user's satisfaction. Prior to the randomized controlled trial (RCT),~     the investigators will conduct a pilot trial to evaluate the preliminary version of the Be a~     Mom program in high-risk women (random assignment to the intervention or to the control~     condition).~      The RCT will be a three-arm prevention trial. Women who have had a child during the prior~     month will be enrolled in the study. A minimum number of 1000 women will be enrolled in the~     study. After agreeing to participate in the study, the women will be screened for the~     presence of risk factors for PPD and early-onset PPD symptoms (using self-report~     questionnaires) by a researcher (licensed psychologist). In case of a negative screen,~     women's participation in the study will end. In case of a positive screen (high-risk women),~     women will be randomly assigned to one of the conditions: the Be a Mom program, the Be a Mom~     program with partner (the partner will be invited to assist the program with the woman), or~     the control condition. The sample will be recruited at the maternities of Coimbra University~     Hospitals-CHUC, EPE.~      Participation in the study will last 11 months. The Be a Mom program will last 5 weeks.~     Participants in both conditions will be invited by the researchers via email to complete~     baseline, post-intervention and follow-up (4-months and 12-months after childbirth)~     assessments. Assessments will include self-report questionnaires to assess several indicators~     (e.g., depressive and anxiety symptoms, dyadic adjustment, mother-child bonding, and maternal~     confidence), mechanisms that may be involved in the treatment response (e.g., negative~     automatic thoughts, psychological flexibility, emotional regulation) and user's acceptability~     and satisfaction.~   "
41415|NCT03024632|"~     This is a retrospective chart review. The purpose is to look at the outcomes for women and~     newborns who decided to attempt a trial of labor after 3 or more previous cesarean sections.~   "
41416|NCT03024619|"~     This is a pilot study to assess the correlation between urinary pH and Interstitial Cystitis~     (IC) pain, with emphasis placed on exploring the type and severity of pain.~   "
41417|NCT03024606|"~     The investigators propose an 18-month, randomized, open-label evaluation of the impact of~     texting to pregnant, underserved, cigarette smokers on smoking cessation rates. Patients will~     be eligible if they have a confirmed pregnancy, are English speaking, at least 18 years of~     age, are in the preparation stage of change and willing to set a quit date within 30 days and~     before 35 weeks gestation, and have a cellular phone that is capable of receiving text~     messages. Patients will be randomized to either the texting group or control group. A~     baseline carbon monoxide level will be obtained. The patient, regardless of group, will have~     the standard of care smoking cessation visit. If the pharmacist, physician, and patient deem~     that pharmacotherapy is appropriate, patient will receive nicotine replacement therapy~     patches or bupropion free of charge in 2-week intervals. Patients in the intervention group~     will receive text messages focused on smoking cessation and pregnancy. Patients will be seen~     on a bi-weekly schedule to obtain additional vouchers for patches or for bupropion, meet with~     the pharmacist, and complete a carbon monoxide exhalation test. These visits will be~     continued until the pharmacotherapy course is complete.~   "
41418|NCT03024593|"~     The purpose of the current study is to examine the effects of health-related internet use on~     affect, health anxiety and symptom severity in individuals with pathological levels of health~     anxiety. The present randomized controlled study compares an online medical searching~     condition with a waiting (i.e. non-searching) condition to manipulate the attentional focus.~     After an induction of health anxiety using the Autobiographical Emotional Memory Task the~     participants in the searching condition go online and search for subjectively relevant health~     information (external focus of attention). Individuals in the waiting (i.e. non-searching)~     condition are requested to do nothing and not to distract themselves (internal focus of~     attention).~   "
41419|NCT03024580|"~     This pilot trial evaluates in vivo megestrol acetate (MA) modulation of steroidal receptors~     in advanced breast cancer.~   "
41422|NCT03024541|"~     Anticholinergic and sedative drugs are frequently prescribed to older people, despite their~     negative impact on older people's physical and cognitive function. To estimate the cumulative~     exposure to anticholinergic and sedative drugs, Hilmer et al. published the Drug Burden Index~     (DBI) in 2007. The present study aims to complement previous study findings showing higher~     DBI values to be associated with physical and cognitive impairment. Most previously conducted~     studies of the DBI were either cross-sectional or were longitudinal but with short~     follow-ups. Furthermore, it remains unknown whether higher DBI values carry extra risks for~     patients with dementia. Finally, relatively little is known about the stability of DBI values~     over time. The current project therefore aims to examine (1) longitudinal relationships~     between long-term cumulative exposure to anticholinergic and sedative drugs as measured with~     the DBI and cognitive and physical function, (2) to examine interaction effects between DBI~     exposure and dementia, and (3) to examine trajectories of DBI exposure, i.e. DBI exposure~     remaining stable, declining, increasing or fluctuating over time. These project aims will be~     studied with longitudinal data from eligible participants > 60 years from the LASA study with~     participants being followed-up during two decades, and the longitudinal data from the~     InterRAI consortium. Various clinical outcomes regarding cognitive and physical function will~     be studied. Data will be analysed with generalised linear mixed models and Latent Class~     Growth Analysis.~   "
41423|NCT03024528|"~     Pain experienced by critically ill patients is a major problem affecting nearly 50% of the~     patients. Assessing pain in critically ill patients is a challenge even in an intensive care~     unit (ICU) with a minimal opioid-based sedation protocol. In patients who are unable to~     self-report pain, behavioural scales are used, such as CPOT - Critical Care Pain Observation~     Tool.~      Aim: The aim of this study was to validate the Polish version of a behavioural pain~     assessment method - CPOT in an ICU with a minimal sedation protocol (opioid-based) versus~     self-report pain using Numeric rating scale (NRS) in both delirious and non-delirious~     patients (assessed using Confusion Assessment Method for ICU, CAM-ICU).~      Method: A prospective observational cohort study will include 70 patients. The patients will~     be observed during a non-nociceptive procedure (wash of an arm) and a nociceptive procedure~     (turning). Patients will be observed 5 minutes before, during, and 15 min after the two~     interventions (six assessments). Each CPOT assessment will be carried out by two observers~     blinded to each other. To validate the Polish CPOT translation calculations of interrater~     reliability, criterion validity and discriminant validity will be performed.~   "
41424|NCT03024515|"~     Pain is a common symptom that is experienced by patients with advanced cancer. Whilst mild~     pain can usually be controlled with simple analgesics, more severe pain may require~     initiation of opioid analgesics. The World Health Organization (WHO) has developed a specific~     guideline for titration of analgesics. Known as the WHO Pain Ladder, patients who have severe~     pain despite non-opioid and weak opioid analgesics are advised to step up to level 3 -~     Strong Opioids. Morphine is the most common opioid strong analgesic prescribed in Hong~     Kong. To the best of our knowledge, there is no formal opioid pain control guideline~     developed for cancer patients in Hong Kong. The prescription practices of various physicians~     who treat advance cancer patients, including oncologists and palliative care physicians have~     never been audited or standardized.~      Furthermore, there are inherent issues with the administration of oral morphine. Currently,~     only one fixed concentration is available in a liquid formulation. Patients are known to have~     difficulties in receiving the appropriate dose. Accurate measurement of the volume required~     is extremely difficult, and many a times patients will report to have spilled the oral~     morphine during decanting, or will report that they have not been taking adequate doses~     because they are worried that they will decant too much into a spoon or syringe and overdose~     themselves.~      Oxycodone is a semisynthetic strong opioid analgesic, which has recently been introduced to~     Hong Kong. It is formulated as a capsule, and again, 2 preparations (sustained-release~     (Oxycontin) and immediate release (Oxycodone IR)) are available. Inherent advantages include~     ease of administration; different groups have previously reported less adverse effects and~     better treatment compliance. However, to date, there has been no prospective 'head-to-head'~     comparison have ever been carried out comparing this with the traditional, well-accepted~     methods.~      The purpose of this study is to assess whether or not the use of Oxycontin and Oxycodone IR~     may be superior to traditional medication choices and schedules in terms of time required for~     onset of pain control, the side effect profile, patients' tolerability and compliance to~     treatment. Interestingly, through this randomized open-label prospective study, we also aim~     to capture information on current opioid prescription practices by clinicians who manage~     patients with advanced cancers, which will be useful for us to consider the establishment of~     territory-wide treatment guidelines at a later juncture.~   "
41425|NCT03024502|"~     The present study aims to evaluate the safety of two mucoadhesive gels containing a propolis~     standardized extract identified as EPP-AF, with 1 and 2% of propolis. The efficacy studies~     with both propolis gels will be performed in comparison with clotrimazole cream in patients~     presenting vulvovaginal candidiasis.~   "
41426|NCT03024489|"~     Cyclin D kinase 4 (CDK4) is a key regulator of the G1-S transition in the cell cycle.~     Alterations in CDK4-cyclin D-retinoblastoma (Rb) pathway may lead to carcinogenesis in many~     cancers. Several mechanisms have been described: (i) Amplification or overexpression of~     cyclin D1, (ii) Amplification of CDK4, (iii) Activating mutation of CDK4, and (iv) Loss of~     the CDK4 inhibitor, p16 (CDKN2A). Human Papilloma Virus (HPV) plays a major role in squamous~     cell carcinoma of head and neck (SCCHN) carcinogenesis. It induces many alterations in the~     CDK4-Cyclin D-Rb and apoptotic pathways such as up-regulation of p16, loss of Rb and p53~     functions. A novel therapy for HPV-negative SCCHN is clearly an unmet medical need.~      Palbococlib (PD 0332991) is an orally active, highly selective inhibitor of the CDK4/6 with~     ability to block Rb phosphorylation in the low nanomolar range. The most advanced development~     is in a treatment of metastatic breast cancer. In addition, palbociclib showed a~     radiosensitization property. Since combination of cetuximab and radiation improved PFS and~     overall survival (OS) in locally advanced unresectable SCCHN when compared with radiation~     alone, these provide a strong rationale to evaluate a combination of palbociclib, cetuximab,~     and radiation for locally advanced unresectable SCCHN. Because many genetic alterations in~     SCCHN significantly involve in the CDK4-cyclin D-Rb pathway, predictive biomarker(s) of~     palbociclib in this combination will be explored.~      Thus, the investogators propose a non-randomized, dose escalation, phase I study designed to~     determine the maximum tolerated dose (MTD) and toxicity of palbociclib, cetuximab, and IMRT~     for locally advanced unresectable SCCHN.~   "
41427|NCT03024476|"~     BOSS-Trial I is a phase 2 clinical trial with the following objectives;~        1. to prove the feasibility of a Bluetooth-equipped sphygmomanometer system in real-world~          clinical practice and wireless connection to the main server;~        2. to prove the feasibility of the BP management strategy, including the pre-specified BP~          range, BP management algorithm, and behavioral; and~        3. to gather information for the phase 3 trial including BP variability indices and their~          potentials as a treatment guidance.~   "
41428|NCT03024463|"~     In addition to axillary lymph node (ALN), internal mammary lymph node (IMLN) chain is also~     the first-echelon nodal drainage site for metastasis and it provides important prognostic~     information in breast cancer patients. However, decision about local treatment of IMLN is~     still being made based on ALN status. The 2016 National Comprehensive Cancer Network~     Guidelines recommend internal mammary lymph node irradiation for patients with more than 4~     positive ALNs (category 1), and strongly consider irradiation for patients with 1 to 3~     positive ALNs (category 2A). Therefore, there will be patients in positive ALN subgroup who~     just face complications of an unnecessary radiation to IMLN and there will be patients in~     negative ALN subgroup who do not receive adjuvant radiation therapy they really need. Thus,~     these inclusion criteria of National Comprehensive Cancer Network might lead to~     over-treatment and under-treatment. Internal mammary sentinel lymph node biopsy (IM-SLNB)~     provides a less invasive method of assessing the IMLN than surgical dissection. However, low~     visualization rate of IM-SLN has been a restriction of IM-SLNB. A modified radiotracer~     injection technique was established in our previous study. This technique could significantly~     improve the IM-SLN detection rate. The investigators have validated the accurate of the~     hypothesis and the modified radiotracer injection technique in the previous study.~      For axillary sentinel lymph node biopsy, the success rate and the accuracy are the most~     important technical indicators. The relatively lower false-negative rate is a precondition~     for the widely application of SLNB. Axillary SLNB needs to be accomplished with the~     cooperation of multi-disciplinary teamwork, including the breast surgery, the radiologist,~     the nuclear medicine doctor and the pathologist, in order to obtain a better success rate and~     a lower false-negative rate. Our previous studies confirmed that the modified radiotracer~     injection technique can greatly improve the IM-SLN detection rate. However, whether the~     IM-SLNB based on the modified radiotracer injection technique has a low false negative rate~     or not still need to be confirmed by a further validation research.~      Furthermore，recently, the investigators propose that if IM-SLN is the only metastatic lymph~     node and there would be no positive node else in IMLN chain, the radiotherapy and its~     associated complications could be avoided in these patients. On the other hand, if there is~     the presence of metastatic non-sentinel lymph node (NSLN) in IMLN chain after IM-SLNB, it is~     important to predict the risk of IM-NSLN metastasis in IM-SLN positive patients. As there is~     currently no such model, a predictive model for IM-SLN positive patients to avoid~     radiotherapy is needed in this situation. Therefore, a new study will be conducted to verify~     the issues above.~      In the current study, all the participants (18~70 years of age) would have the preoperative~     pathology of invasive breast cancer and positive fine-needle aspiration result in their~     clinical or ultrasonic suspicious axillary lymph node. 99mTc-labeled sulfur colloid was~     injected into the parenchyma under the ultrasound guidance 3 to 18 hours before surgery. Two~     syringes of 9.25 to 18.5MBq 99mTc-labeled sulfur colloid in 0.5 to 0.7mL volume were injected~     at the 6 and 12 o'clock positions 0.5 to 1.0 cm from areola (about 2.0~4.0 cm from the~     nipple). IM-SLNB was performed in all participants with IMSLN visualized on preoperative~     lymphoscintigraphy and/or detected by the intra-operative gamma probe. All hotspots in the~     internal mammary basin were harvested and intra-operative identification of the IM-SLN was~     based on gamma probe detection. The IM-SLN was sectioned along the long axis into two blocks~     and all blocks were tested by the frozen section and the touch imprint cytology~     intra-operatively. Those participants with positive intra-operative results received IMLN~     dissection. Finally, all the IM-SLN blocks and IM-NSLN dissected were assessed~     post-operatively by H&E and Cytokeratin 19 stained immunohistochemistry. The conclusion would~     be drawn through the results mentioned above.~   "
41430|NCT03024437|"~     This study will assess the immunomodulatory activity of entinostat in patients with advanced~     renal cell carcinoma receiving the PD-L1 inhibitor atezolizumab. The overall hypothesis is~     that entinostat will increase the immune response and anti-tumor effect induced by the PD-L1~     inhibition by suppressing Treg function. We have chosen renal cell carcinoma that has been~     reported to respond to PD1/PD-L 1 inhibition. The schedule of entinostat is based on our~     previous experience with this agent. Based on our working hypothesis that low dose HDAC~     inhibitors will have a suppressive function on Tregs but not on T effector cells, the~     starting dose of entinostat will be 1 mg and will be escalated up to 5 mg rather than the 10~     mg dose. The combination also with bevacizumab will provide an effective VEGF inhibition that~     may potentiate the immune response and anti-tumor effect induced by atezolizumab. The~     proposed dose and schedule for atezolizumab and bevacizumab has been shown to be well~     tolerated in prior Phase/I/II studies and is currently tested in a Phase III randomized study~     in patients with renal cell carcinoma with sunitinib as a control arm. The highest proposed~     dose level for entinostat (5 mg) represents 50% of the recommended Phase II dose for this~     compound as a single agent.~   "
41431|NCT03024424|"~     The goals of this study are:~      To assess the impact of genetic testing based on how it alters behaviors, to assess the~     utility of serum biomarker measurement in combination with genetic testing, to assess the~     utility of genetic counseling in personal analysis of risk for age-related macular~     degeneration (AMD), and to assess the impact of presymptomatic genetic testing for choroidal~     neovascularization (CNV).~   "
41432|NCT03024411|"~     Data are lacking regarding the use of music and video games for the management of pain in~     labor. Pregnant women that are scheduled for labor induction with Foley bulb after 37 weeks~     will be approached for participation in the study. Patients will be randomized to a~     music/video games group and a non-music/video games group. Those randomized to group with~     music/video games will be given an iPod for those purposes.The primary outcome will be the~     time for patients to request pain medications after Foley bulb placement. The two groups will~     be compared for differences in pain outcomes.~   "
41433|NCT03024398|"~     Selective lymphadenectomy Sentinel (LSS). This technique is already well established in~     breast cancer and melanoma and more recently in vulvar and cervical cancer.~      Compared to lymphadenectomy, it has several theoretical advantages:~        -  this is a sensitive technique with a detection rate of> 90% and a false negative rate of~          <5%.~        -  the anatomopathological techniques used (immunohistochemistry with anti-cytokeratin~          antibodies, serial sections) are more sensitive than the standard histological analysis~          of lymphadenectomy, which allows an improvement in the detection of metastases~          (micro-metastases, isolated tumor cells). In the SENTI-ENDO study, it was possible to~          detect lymph node metastases in 11% of patients with low-risk endometrial cancer and in~          15% of intermediate-risk patients.~        -  it avoids short-term and long-term operative and post-operative morbidity of~          lymphadenectomy.~      Early studies of LSS in endometrial cancer demonstrated superior efficacy of the colorimetric~     method coupled with the Technetium 99m isotopic method with an overall detection rate of 78%~     [95% CI: 73-84]. The fluorescent green of indocyanine appears to give better results with an~     overall detection rate of 94% and a bilateral detection rate of 80%.~      It seemed useful to take stock of this technique using this new dye.~   "
41434|NCT03024385|"~     This model will utilize tools from the IMPLICIT (Interventions to Minimize Preterm and Low~     Birth Weight Infant through Continuous Quality Improvement Techniques) Network (collaboration~     of academic family medicine providers). The project involves assessing maternal risk~     behaviors that significantly affect subsequent birth outcomes: specifically smoking~     cessation, maternal depression, family planning and preconception folic acid supplementation~     during well child (WCC) visits. There is evidence that screening mothers for depression can~     be done at WCC. Data from IMPLCIT network has demonstrated increased screening and referral~     rates as well as decreased rates of prematurity. This is the first collaborative effort~     between Pediatrics and Family Medicine.~   "
41435|NCT03024372|"~     The purpose of this study is to investigate a promising strategy to improve maturation and~     patency rates following creation of AV fistulas and assess whether an anastomosis performed~     with Anastoclips (interrupted, nonpenetrating) would produce better maturation and/or patency~     than one performed with conventional suturing techniques.~   "
41436|NCT03024359|"~     Considering the high prevalence of obesity its comorbidities in Brazil and in the world,~     different therapeutic measures have been suggested. It is currently known that brown/beige~     adipose tissue plays an important role in body weight control and there is strong evidence~     that its activity is inversely associated with obesity and metabolic diseases. Recent studies~     have shown an important role foods and nutrients in the activation of brown/beige adipose~     tissue, almost exclusively in animal models. The benefits of monounsaturated fatty acids to~     metabolism have been described in several studies, however, the effects of consuming large~     amounts of olive oil in the activity of brown/beige adipose tissue in humans have not been~     explored. The aim of the study is to evaluate the impact of the consumption of large amounts~     of extra virgin olive oil in the activity of brown/beige adipose tissue in lean and obese~     humans. This will be a clinical trial with a total duration of 4 weeks. Obese and controls~     (normal weight) participants will undergo a dietary intervention for 4 weeks with extra~     virgin olive oil. Before and after the intervention period several data will be collected:~     dietary intake and physical activity data, evaluation of brown/beige adipose tissue (with~     18F-fluorodeoxyglucose positron emission tomography and magnetic resonance imaging -~     PET/RMI), assessment of body composition (DXA), lipid profile and inflammatory markers as~     well as hypothalamic inflammation (functional magnetic resonance imaging) and brown adipose~     tissue biopsies in a subsample of 20 participants. The data will be expressed as mean and~     standard deviation and the variables compared by the Student t test or ANOVA for repeated~     measures.~   "
41437|NCT03024333|"~     This study is aimed to establish and identify the normal pattern of swallowing sounds and~     analyze swallowing sounds of different textured foods and viscous liquids in healthy subjects~     to provide clinical evidence to update dysphagia patients' food.~   "
41462|NCT03024008|"~     The purpose of this clinical study is to evaluate the safety and the efficacy of BonoFill-II~     as an autologous bone-regenerating graft in the reconstruction of deficient bone in two~     clinical indications:~        1. Long bone extra-articular comminuted fracture~        2. Large bone defect or gap incapable of self-regeneration~   "
41438|NCT03024320|"~     The study uses a theory-driven eHealth platform and innovative physical activity (PA) program~     referred to as movement-to-music (M2M) to deliver a customized, home-based PA intervention~     for adults with physical disability (PWD). Participants will be recruited through a large~     physical medicine and rehabilitation network of clinics specializing in treating patients~     with physical disability. Clinicians and their patients will be cluster randomized to one of~     three groups: a) M2M; b) M2M plus social networking (M2Mplus); and c) attention control (AC).~     Participants will be followed for 48 weeks to obtain objective measures on physical activity,~     fitness and self-reported measures on health at four time points. Participant physicians will~     receive information on their patients' progress (i.e., adherence and outcomes) across the~     48-week study period. The study will compare the effectiveness of M2M and M2Mplus in~     increasing physical activity and adherence compared to the AC group, estimate the~     improvements in health of M2M and M2Mplus compared to the AC group, and examine the mediators~     and moderators of the hypothesized treatment effect to understand for whom and how the~     intervention is effective. This multi-level, scalability study will strengthen our~     understanding of the potential benefits of eHealth to eliminate barriers to PA participation~     among PWD.~   "
41439|NCT03024307|"~     This is a randomised trial on the efficacy of an Outpatient Pharmacy Clinical Services~     Program (OPCSP) on adherence and clinical outcomes among patients with rheumatic diseases.The~     purpose of this study is to evaluate:~        1. rates of medication adherence in the OPCSP program compared with usual care in an~          integrated health care system.~        2. total direct costs and clinical outcomes in the OPCSP program compared with usual care~          in an integrated health care system.~   "
41440|NCT03024294|"~     The goal of this study is to create a unified SOP for care of subjects undergoing VATS~     lobectomy and segmentectomy by members of the Division of Thoracic Surgery. Other academic~     centers have created standardized algorithms for the care of their subjects and this enables~     the centers to determine which subjects can be placed on an accelerated pathway to discharge~     and which cannot. Some of these SOPS dictate uniform treatment algorithms with reduction in~     what may be unnecessary tests to simplify patient care and likely accelerate them towards~     safe and more timely discharge from the hospital.~   "
41441|NCT03024281|"~     Primary objectives:~        1. To investigate the prevalence of azole resistance in Aspergillus clinical isolates~          collected in participating hospitals in Taiwan~        2. To investigate the prevalence of azole resistance in Aspergillus environmental isolates~          in Taiwan~        3. To characterize the molecular mechanisms of azole resistance in Aspergillus isolates in~          Taiwan~        4. To investigate the clonality of Aspergillus clinical and environmental isolates in~          Taiwan~        5. To describe the genetic relationships between local resistant strains with global~          strains~      Secondary objective:~        1. To describe the clinical characteristics and treatment outcome of patients with proven~          or probable invasive aspergillosis~        2. To evaluate the clinical impact of azole resistance in patients with proven or probable~          invasive aspergillosis in a case-control study~   "
41442|NCT03024268|"~     Aim of this prospective trial is to assess the hemodynamic effects of a MitraClip procedure~     caused iatrogenic arterial septal defect (iASD) and the functional changes after~     interventional iASD closure in a randomized setting.~   "
41443|NCT03024255|"~     This study is being conducted to assess the safety and efficacy of 3 concentrations of~     BBI-4000 and vehicle (4 treatment arms), applied for the treatment of axillary hyperhidrosis.~   "
41444|NCT03024242|"~     Bivalve vaginal speculum insertion is a basic final step of vaginal examination.~     Unfortunately, it can't be inserted in young girls, virgins, nulliparous women with narrow~     vagina, women with vaginismus or patients with a history of previous vaginal surgery. In such~     cases, the value of vaginoscopy (examination of the vagina without speculum) is evident.~     Indications of vaginoscopy are expanding. In addition to confirmation of suspected vaginal~     masses or polypi diagnosis, it can be used to diagnose laceration of the vaginal wall in~     girls due to foreign body , traumatic injuries or sexual abuse. In a systematic review, the~     effectiveness and feasibility of using hysteroscopy for exploration of the immature genital~     tract (vaginoscopy) were documented.It may help in the diagnosis and treatment of gynecologic~     disorders in adolescent patients with an intact hymen, limited vaginal access, or a narrow~     vagina. Another recent systematic review highlighted the importance of Vagino-hysteroscopy as~     an easy way to gain access to the cervical canal and an important tool with which to diagnose~     and treat vaginal lesions.~      In practice, we notice leakage of excessive irrigating fluid per vagina with poor~     visualization during vaginoscopy. To the best of our knowledge, no study addressed a solution~     to improve visualization and success of vaginoscopic surgery. This study aims to test~     feasibility and doctor satisfaction of performing conventional diagnostic vaginoscopy if~     compared to tight diagnostic vaginoscopy and success on performing tight vaginoscopic surgery~     in patients with vaginal or cervical lesions.~   "
41445|NCT03024229|"~     When the kidneys are perfused on perfusion machines before transplantation, the resistance~     parameters as well as the histological score on the pre-implantation biopsy participate in~     the evaluation of the quality of the graft. The metabolomic profile of the infusion fluid~     could provide additional evidence.~   "
41446|NCT03024216|"~     The purpose of the study is to compare the safety and tolerability of sequential atezolizumab~     followed by sipuleucel-T (Arm 1) vs. sipuleucel-T followed by atezolizumab (Arm 2) in~     patients who have asymptomatic or minimally symptomatic metastatic CRPC, not previously~     treated with docetaxel or cabazitaxel.~   "
41447|NCT03024203|"~     Cognitive remediation (CR) is the best treatment to improve neurocognitive abilities for~     individuals with psychosis, however, there is no gold standard method of cognitive~     remediation available. Cognitive training refers to the training component of CR in which~     people practice computerized exercises that train specific cognitive abilities. There is no~     agreed upon approach within the field as to the type of training that is most effective with~     some studies, training higher level cognitive abilities, some training perceptual abilities,~     and others training general cognitive skills. This study will directly compare two competing~     methods of cognitive training on measures of neurophysiology, neurocognition, functional~     competence, and real-world functional performance.~   "
41552|NCT03022838|"~     Sporadic and chronic dietary consumption of caffeine has substantial biological effects on~     the nervous system. The effects on migraine are at large not known. In this study we want to~     assess the effects of caffeine withdrawal on migraine.~   "
41448|NCT03024190|"~     Poststroke spasticity (PSS) is one of the common complications in stroke patients who had a~     brain injury leading to limbs weakness and impaired coordination between agonist and~     antagonist contraction. PSS leads some physical impairments and functional deficits. The~     clinical managements for PSS are stretching and range of motion (ROM) exercises,~     antispasticity splint, neuromuscular electrical stimulation, oral medications, local~     injection with phenol or botulism, or surgery. Recently, some investigators tried to use~     Kinesiotaping (KT) for spasticity management or postural control. They found some benefits in~     walking ability and upper extremity function facilitation after stroke.~      40 subacute stroke patients with hemiplegia would be enrolled in this study. These 40~     patients will be randomly divided into the experimental and control groups. In experimental~     group (n=20), the patients will perform combined KT and 15- min stretching exercise for upper~     extremity twice daily and regular rehabilitation program for 3 weeks. In the control group~     (n=20), the patients will perform 15- min stretching exercise for upper extremity twice daily~     and regular rehabilitation program for 3 weeks. Before intervention, immediately and 2 week~     post intervention, all patients will receive associated physical examinations, hand function~     evaluations, and sonography.~   "
41449|NCT03024177|"~     This is a randomized, double-blind, placebo-controlled study of vapendavir treatment of~     laboratory-confirmed and symptomatic HRV infection of the upper respiratory tract in~     allogeneic and autologous stem cell transplant subjects. The aim of this study is to evaluate~     the effect of vapendavir on laboratory-confirmed HRV upper-respiratory tract infection in~     HSCT patients, as measured by viral load changes, worsening of upper respiratory tract~     infection (URTI) to lower respiratory tract infection (LRTI), duration of clinical symptoms,~     the occurrence of supplemental oxygen use, duration of viral shedding, hospital admission and~     duration of hospitalization, incidence of secondary bacterial infection, and mortality rates.~     Additionally, the safety and tolerability of vapendavir, and the vapendavir plasma levels~     achieved in the HSCT population, and the profile of viral resistance development will also be~     assessed.~   "
41450|NCT03024164|"~     This is a multi-center, prospective,continuous registry study. The investigators will include~     3000 young adult (18-45 years old) patients with confirmed first-ever acute ischemic stroke~     in China. The main purpose of this study is to build the study cohort of young ischemic~     stroke patients in China, and to compare the prognosis and stroke recurrence of young~     patients with different ischemic stroke subtypes. Secondary objectives are trying to find~     biomarkers of stroke recurrence.~   "
41451|NCT03024151|"~     The goal of this research is to compare the effects on psychological distress between T4 mono~     replacement group and T4/T3 combination replacement group after total thyroidectomy in~     thyroid cancer patients.~        1. Subjects:~             -  Psychologically distressed patients, such as depression, anxiety, and fatigue~               patient after total thyroidectomy with thyroid cancer are considered for~               participation. Screening of distress after total thyroidectomy is used HADS~               (Hospital Anxiety and Depression Scale) ≥ 8 for depression or anxiety, and MDASI-F~               (MD Anderson Symptom Inventory -Fatigue) ≥ 4 for fatigue.~        2. Randomization:~             -  Using the table of random sampling numbers, patients assign to T4 mono replacement~               group or T4/T3 combination replacement group.~        3. Evaluation for distress:~             -  Assessment will be made baseline, 4 weeks, 12 weeks and 24 weeks to investigate~               change of psychological distress (depression, anxiety, and fatigue). Level of~               distress after thyroidectomy will determine using Hospital Anxiety and Depression~               Scale (HADS), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI) for~               depression or anxiety, and Brief Fatigue Inventory (BFI) for fatigue.~   "
41452|NCT03024138|"~     Radiotherapy (combined with chemotherapy) is increasingly applied in the curative treatment~     of tumours located in the thoracic region (esophageal cancer, lung cancer, breast cancer, and~     (non) Hodgkin lymphoma). Accurate radiotherapy planning and delivery is essential for the~     treatment to be effective. However, this accuracy is compromised by tumour and organ motion.~     Radiotherapy treatment planning is typically performed on a planning-CT scan recorded several~     days prior to commencement of radiotherapy. Inter-fraction set up variations and organ motion~     during treatment can lead to differences between the calculated dose distribution on the~     planning-CT and the radiation dose actually received by the tumour and normal organs.~     Accurate assessment of these effects is essential to determine optimal margins in order to~     irradiate the tumour adequately while minimizing the dose to the organs at risk (OARs).~      In the near future, patients with esophageal cancer, lung cancer, breast cancer and (non)~     Hodgkin lymphoma are excellent candidates for proton beam therapy (PBT), which enables marked~     reductions of the radiation dose to the OARs and thus decreasing the risk of radiation~     induced cardiac and lung toxicity. However, for PBT using pencil beam scanning (PBS),~     knowledge of tumour and organ motion will be even more important. The potential major~     advantages of PBS for tumours in the thoracic region are challenged by the respiratory motion~     of the tumour, breast, esophagus, diaphragm, heart, stomach, and lungs. Setup errors and~     inter- and intra-fraction organ motion cause geometric displacement of the tumours and normal~     tissues, which can cause underdosage of the target volumes and overdosage of the organs at~     risk. Furthermore, it can result in changes in tissue densities in the beam path, which can~     alter the position of the Bragg peaks and lead to distorted dose distributions. If pencil~     beam scanning techniques are used to treat moving tumours, there is interplay between the~     dynamic pencil beam delivery and target motion. This phenomenon can cause additional~     deterioration of the delivered dose distribution, usually manifesting as significant local~     under and/or over dosage. It is therefore essential to incorporate motion-related~     uncertainties during treatment planning.~      The main objective of this study is to evaluate the impact of inter-fraction tumour and organ~     motion - while taking into account intra-fraction movements appropriately - on photon and~     proton radiotherapy treatment planning in order to yield robust intensity modulated photon~     and/or proton treatment plans.~      Objective: To evaluate the impact of inter-fraction tumour and organ geometrical dislocation~     for moving tumours on photon and proton radiotherapy treatment plans in order to create~     robust intensity modulated photon- and/or proton treatment plans.~      Study design: Pilot-study (80 patients).~      Study population: Patients with esophageal cancer (EC), (non) small cell lung cancer~     ((N)SCLC) stage III, breast cancer, or (non) Hodgkin lymphoma who will be treated with~     radiotherapy (with or without chemotherapy) with curative intent.~      Intervention (if applicable): Not applicable.~      Main study parameters/endpoints: Robustness parameters (homogeneity index; coverage of~     clinical target volume), dose to organs at risk (OARs), such as the heart (mean heart dose,~     MHD) and the lungs (mean lung dose, MLD).~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: During the radiotherapy treatment course, patients will undergo weekly repeat~     planning CT scans in treatment position without contrast agents in order to evaluate the~     impact of inter-fraction tumour and organ motion.~      Furthermore, additional CBCTs are collected after 10 radiotherapy fractions to assess the~     intra-fraction motion.~      The additional radiation dose of these 3-6 4D-CT's and 10 CBCTs is low (4-6 x 25-30mSv + 10 x~     7mSv results in an effective dose < 250mSv) compared to the therapeutic radiation dose~     (40-60Gy). The risks are therefore negligible and the burden is low.~   "
41453|NCT03024125|"~     This study evaluates the effect of different types of diets (high and normal protein) on lean~     and fat mass, and strength in postmenopausal women practitioners of resistance exercise. Two~     groups will be created: high protein (1.2 protein g/body mass/day) and normal protein (0.8~     protein g/body mass/day). The same training will be performed for both groups.~   "
41454|NCT03024112|"~     The Investigators goal was to study the effect of high flow nasal cannula oxygen (HFNC) on~     the rate of post-operative pulmonary complications in thoracic surgical patients. The~     Investigators hypothesis is that prophylactic HFNC oxygen, as compared to standard oxygen~     treatment, will reduce the incidence of postoperative pulmonary complications, improve~     post-operative pulmonary function, and reduce Intensive Care Unit (ICU) and hospital length~     of stay.~   "
41455|NCT03024099|"~     The hippotherapy is considered a therapeutic modality that provides numerous benefits in the~     rehabilitation process and has often been recommended by doctors for children with cerebral~     palsy. Despite being in frank ascent, this therapy still lacks scientific evidence.~     Objectives: To analyze and compare the effects of hippotherapy program, often 1 or 2 days a~     week in gross motor function, trunk balance and functional performance of children with~     cerebral palsy.~   "
41456|NCT03024086|"~     The purpose of this study is to evaluate the Efficacy and Safety of DWJ1252 in treatment of~     Functional Dyspepsia.~   "
41457|NCT03024073|"~     Patients who underwent presbyopic correction with bilateral bifocal intraocular lenses~     implantation are supposed to have sufficient uncorrected vision capacity for activities of~     daily living (ADLs) that require near vision acuity (NV), (ie. book reading). However, it is~     known that light intensity and temperature has a great impact on near vision capacity.~     Primary objective of this study is to identify the optimal task lighting conditions (in terms~     of light intensity and temperature) for ADLs that demand near vision acuity for a sample oa~     patients who underwent presbyopic correction with bilateral bifocal intraocular lenses~     implantation~   "
41458|NCT03024060|"~     The purpose of this study is to prove the safety and efficacy of Levulan Kerastick~     (aminolevulinic acid HCl) for Topical Solution 20% followed by 10 J/cm2 of blue light~     delivered at 10 mW/cm2 or 20 mW/cm2 in the treatment of multiple actinic keratosis on the~     face or balding scalp (the Treatment Area), utilizing a 14-18 hour incubation period.~   "
41459|NCT03024047|"~     Background:~      Disturbances of the heart's atrioventricular conduction - AV-block - may show by shortness of~     breath, fainting or sudden death. If AV-block is diagnosed in time pacemaker therapy may be~     lifesaving.~      AV-block in younger can be seen along with structural or ischemic heart disease, congenital~     heart disease (incl. congenital AV-block) storage disorders, specific muscle diseases,~     sarcoidosis, Borrelia infection or drug intoxication. AV-block in younger can also be seen in~     conditions, primarily localized to the AV-node without other cardiac disease at diagnosis.~      This form of AV-block is often hereditary and can be seen in families where relatives have~     another types of heart disease in form of fore example, cardiomyopathy, ion channel disease~     or sudden death. The different forms of presentation are due to the same gene mutation being~     expressed differently within the same family. Thus, early onset of AV-block (<50 years) may~     indicate hereditary AV-conduction disorder but it can also be the first manifestation of~     severe ion channel disease or cardiomyopathy.~      Denmark has annually over 50 individuals <50 years treated with pacemaker due to advanced~     AV-block. There have been no overall figures regarding the causes of advanced AV-block, and~     therefore no systematic approach to diagnosing this group of patients. Furthermore, the~     prevalence of individuals with a genetic cause of AV-block is unknown and presumably an often~     overlooked diagnosis among younger patients with advanced AV-blok. There are no data on~     disease progression after diagnosis, and therefore there is no evidence-based knowledge about~     how these patients should be followed after diagnosis.~      With modern gene technology, a range of new, yet unknown genes with potentially pathogenic~     mutations is likely to be identified. Identification of such genes, and the development of a~     strategy for systematic approach to diagnose younger patients with AV-block, will enable~     presymptomatic genetic screening of relatives and implementation of evidence-based,~     preventive treatment with pacemaker and/or medical treatment for heart failure based on a~     specific genetic predisposition for development of AV-block with or without heart failure.~      Hypotheses:~      In a significant proportion of younger patients with advanced AV-block the underlying cause~     is unknown.~      Objective:~      To investigate the prevalence and causes of advanced AV-block in younger patients in Denmark~     and describe the current diagnostics.~      Method:~      The study is a cross sectional study. The patients for this study are identified from Danish~     Pacemaker and ICD Register. The investigators will review medical records and obtain clinical~     information and test results (see detailed description).~      Perspectives:~      This study is the first part of a large study of AV-block in younger patients in Denmark. The~     overall goal, is to increase knowledge about the causes of and disease progression after the~     diagnosis of advanced AV-block in young patients which could lead to a significant~     improvement in the treatment of this patient group and may lead to a customized choice of~     pacemaker type in the future and perhaps additional medical treatment in this patient group.~     This could potentially lead to a reduction in both their morbidity mortality.~   "
41460|NCT03024034|"~     The purpose of this study is to determine the safety and tolerability of up to 6 different~     single ascending oral doses of TP-271, ranging from 25 mg to 300 mg, in healthy adult male or~     female subjects.~   "
41461|NCT03024021|"~     This study is designed to assess the effect of cerebral oxygen saturation as an early~     predictor of neurological outcomes in patients undergoing therapeutic hypothermia after~     cardiac arrest~   "
41463|NCT03023995|"~     Over the years, numerous surgical techniques such as free autografts and pedicle grafts have~     been introduced to correct gingival recession defects. Combination grafts with either~     autografts or allografts, and newer concepts of guided tissue regeneration (GTR), platelet~     concentrates, etc., were developed more recently to correct mucogingival defects. The use of~     PRF in various surgical procedures such as degree II furcations, intrabony defects, sinus~     floor segmentation during implant placement and on facial plastic surgeries have shown~     promising results. However to our knowledge, till this study was completed, no studies have~     been reported with the clinical outcomes of autologous platelet rich fibrin membrane for the~     treatment of localized gingival recession defects.~      Hence, this study was designed to compare coronally advanced flap with platelet rich fibrin~     membrane versus subepithelial connective tissue graft in treatment of Miller's Class I and~     Class II gingival recession defects.~   "
41464|NCT03023982|"~     A new conceptual regional anesthesia the PECs II block (modified pectoral and serratus nerves~     block) has been described for pain control after thoracic surgery, one of the indications to~     perform this method is analgesia for surgeries or procedures involving lateral chest wall~   "
41465|NCT03023969|"~     Low back pain is very common problem, variable modalities have been introduced to control~     such problem. One of the emerging modalities is the ozone - oxygen (O2-O3 ) mixture that~     could reduce the herniation disk size and inflammation.~   "
41466|NCT03023956|"~     From April ,2014 to April 2015,31 patients with fractures of the proximal humerus were~     treated in our hospital. According to anatomic neck fractures (ANF) and surgical neck~     fractures (SNF), we divided the patients into two groups. All the patients were followed at~     least 1 year.~   "
41467|NCT03023943|"~     The research design will be single group pretest-posttest design. The subject will be~     instructed to position the knee joint to a position previously set by the experimenter.~     Intervention will be 10 minutes of GT1 instrument application at anterior thigh using sweep~     technique.~   "
41468|NCT03023930|"~     The purpose of this study is to evaluate the impact of (1) Implementation Facilitation (IF)~     on rates of provision of Emergency Department (ED)-initiated buprenorphine/naloxone (BUP)~     treatment with referral for ongoing medication-assisted treatment (MAT) and the (2)~     effectiveness of IF on patient engagement in formal addiction treatment at 30 days.~   "
41469|NCT03023917|"~     The overall objective of the present study is to examine the effects of umbilical cord~     milking at birth in preterm infants to prevent and decrease anemia using a multi-center~     prospective randomized controlled trial comparing immediate cord clamping (standard at~     present) with umbilical cord milking.~   "
41470|NCT03023904|"~     This phase II trial studies how well nivolumab works in treating patients with stage IV lung~     cancer or that has come back after initial treatment who has high mutation loads. Monoclonal~     antibodies, such as nivolumab, may block tumor growth in different ways by targeting certain~     cells.~   "
41471|NCT03023891|"~     This study evaluates the effect of acute administration of oral prednisone in white blood~     cells counts and glucose tolerance and the relationship of these measures with changes in~     gene expression in healthy volunteers. White blood cells counts, glucose tolerance and gene~     expression will be study before and after prednisone administration.~   "
41472|NCT03023878|"~     A phase 2, multicenter, open-label, single arm clinical trial in adult subjects with newly~     diagnosed aggressive high-risk DLBCL.~   "
41473|NCT03023865|"~     The treatment of long gap esophageal atresia (LGEA) in neonates is one of the most~     challenging congenital malformations in neonatal surgery. Usually the proximal and distal~     segments of the esophagus are too far apart, which leads to primary anastomosis abandoned.~     Thus various techniques have been used including Circular and spiral myotomies、Foker and~     Kimura elongation and gastrointestinal replacement. They are being widely used but bring more~     complications and less effectiveness. And considering about the absence of definite guideline~     for the diagnosis and treatment of LGEA worldwide, We prepare to use a preoperative staged~     stress function procedure for elongation of the proximal and distal segments, then to obtain~     an exact evaluation of the pouch status to achieve an individualized protocol of diagnosis~     and treatment utilizing the native esophagus to establish esophageal continuity for patients~     with LGEA.~   "
41474|NCT03023852|"~     The purpose of this study is to assess the rate and extent of absorption of JNJ63623872~     following administration of a single oral dose of 2*300 milligram (mg) given as 2 concept~     single agent tablet formulations compared to the administration of 2*300 mg JNJ63623872~     reference tablets, under fasted conditions in healthy adult participants and to assess the~     rate and extent of absorption of JNJ63623872 and oseltamivir following administration of a~     single oral dose of 2*300 mg/37.5 mg JNJ63623872/ oseltamivir given as a concept fixed dose~     combination (FDC) tablet formulation compared to the coadministration of 2*300 mg JNJ63623872~     tablets (reference formulation) and 1*75 mg oseltamivir capsule, under fasted conditions in~     healthy adult participants.~   "
41475|NCT03023839|"~     Delirium is very common in intensive care unit (ICU) patients and leads to poor outcomes.~     There is little information on delirium in injured patients however. This study determined~     the incidence and risk factors for delirium in severely injured patients.~   "
41476|NCT03023826|"~     The purposes of this study are to determine:~        -  If there are any differences in the way LY3202626 is handled by the body when taken in~          two different forms~        -  Whether a high fat meal affects the way the body handles LY3202626~        -  How well tolerated LY3202626 is~      There are three (3) study periods for all participants. Participants will be admitted to the~     clinical research unit (CRU) each period and will be discharged from the CRU following the~     completion of 2 overnight stays and up to 36 hours after dosing with LY3202626.~      The study will last about 50 days, not including screening.~   "
41477|NCT03023813|"~     The primary objective of this study is to help patients compare the benefits of various~     preventive care services, based on their individual risk factors (such as smoking status,~     obesity, high blood pressure, high cholesterol, etc.). Tailored decision aids will be~     provided to each participant during primary care appointments to facilitate discussion~     between the participant and his/her provider regarding prioritizing preventive service~     recommendations.~   "
42565|NCT03009604|"~     Mechanical bowel preparation aims to decrease the volume fecal content in the colon, which~     thereby decreases the total colony count of bacteria, thus, decreasing peritoneal~     contamination in case of bowel injury, improving the access to the surgical field and~     facilitating intraoperative bowel manipulation~   "
41482|NCT03023748|"~     This study aims to provide intravenous paritcalcitol treatment for the sick and poor~     hemodialysis patients with severe secondary hyperparathyroidism (SHPT) resistant to existing~     vitamin D analogs therapy or with hypercalcemia precluding the use of existing vitamin D~     analogs.~      The study aims to evaluate the effect of paricalcitol on control of SHPT, biochemical~     parameters of chronic kidney disease-mineral bone disease, cardiac parameters, vascular~     calcification and stiffness parameters and nutrition status in patients receiving chronic~     hemodialysis treatment.~   "
41483|NCT03023735|"~     The goal of this study is to better understand how clinicians give genetic risk information~     to patients from multi-ethnic groups and how patients understand this information and~     remember it and act upon it. In addition investigators want to know how to better communicate~     with patients about complex health issues across the health literacy divide and communication~     gap that exists between doctors and their patients.~   "
41484|NCT03023722|"~     The primary objective of this study is to:~      -Test the activity/response rate per RECIST 1.1 criteria of anetumab ravtansine in patients~     with advanced pancreatic cancer who stain for mesothelin expression~      The secondary objectives of this study are to:~        -  Time to Progression (TTP) defined as time from study treatment to RECIST 1.1~          progression, or death (others going off study will be censored)~        -  Toxicity in pancreatic cancer patients (at 6.5 mg/kg dose)~   "
41485|NCT03023709|"~     The investigators collected blood and lymphoid tissues routinely discarded during surgery~     from adults after a routine seasonal influenza vaccination to determine how immune memory~     develops at the actual site of infection, and how immunization may alter this process.~   "
41486|NCT03023696|"~     C5 palsy (C5P) is a well-known, although rare complication of cervical spine decompression~     surgery. In severe forms, C5P causes debilitating upper extremity weakness involving the~     deltoids and/or biceps brachii muscles, ultimately diminishing these patients' quality of~     life. Furthermore, about half of patients with C5P present with sensory deficits and/or~     intractable pain in addition to the muscle weakness.~      Prophylactic bilateral foraminotomy at the C5 level during cervical decompression surgery has~     been studied recently with the hope that it will minimize the risk of developing a C5 nerve~     root palsy postoperatively. Although the current literature provides some support for this~     claim, there are insufficient data establishing this technique as a proven measure to reduce~     the incidence of C5P. In the present study, we seek to evaluate the effect of bilateral~     foraminotomy on postoperative C5P incidence rates.~      Bilateral foraminotomy has been correlated with a reduced risk of developing C5P following~     cervical decompression surgery, but an identical foraminotomy procedure has never been~     applied in a randomized manner to all qualifying patients in a study. Additionally,~     prophylactic foraminotomy has only been prospectively studied during laminoplasty. In the~     proposed study, bilateral foraminotomy will be randomized to patients receiving cervical~     decompression surgery (laminoplasty, laminectomy, fusion). This is a multicenter randomized~     trial, including the following sites: Cleveland Clinic, Columbia University Medical Center,~     and University of Southern California Spine Center. Patients undergoing cervical~     decompression surgery will be consented and enrolled if they meet the inclusion and exclusion~     criteria. Subsequently, incidence of C5P will be monitored to determine efficacy of~     prophylactic C5 bilateral foraminotomy during cervical decompression.~   "
41487|NCT03023683|"~     The purpose of the study is to investigate and compare the human immune response in~     epithelial cells of the nasopharyngeal mucosa and in blood to live, attenuated influenza~     vaccine (LAIV) in adults and in children.~   "
41488|NCT03023670|"~     The lung is at risk for ischemic insults during total cardiopulmonary bypass because lung~     perfusion is maintained solely by the bronchial arterial system~   "
41489|NCT03023657|"~     Severe brain injuries lead to disorders of consciousness after coma. During this awakening~     period, detection of arousal is critical to the adaptation of medical strategy, but global~     paralysis, including facial expression, make the clinical assessment very difficult.~     Emotional facial expressions are a significant part of this clinical assessment. They are~     both a landmark of the internal state of the patient (comfort versus discomfort) and a~     landmark of the relational level with his environment. Visible emotional facial expression is~     a large temporal phenomenon lasting a couple of seconds, while a microexpression is barely~     noticeable and very brief. These micro expressions are usually produced when one tried to~     voluntary hide emotional expressions. In this study, we hypothesize that some patients~     awakening from coma could still produce microexpression before being able to produce visible~     emotional facial expressions. This ability to produce micro-expression could be an early~     landmark of relational awakening in severe brain lesions.~   "
41490|NCT03023644|"~     Each year, approximately 1 child in every 100 is born with Congenital Heart Disease (CHD),~     making it the most common birth defect. With recent medical advances, more children with CHD~     survive early open-heart surgery, so that there are now 2 to 3 million adult survivors with~     CHD. These survivors face challenges in terms of their cognitive and behavioral development.~     For many, the limitations affect their academic achievement, social adaption and, ultimately,~     their quality of life. Among the most disabling limitations are those that pertain to the~     ability to maintain attention, plan and organize activities, regulate emotions, and develop~     problem-solving strategies. Collectively, these are referred to as executive functions (EF)~     because they are higher-order abilities that enable one to coordinate complex behaviors.~     Additionally, impaired EF also underlie mental health disorders. In spite of the abundance of~     evidence that children with CHD struggle with EF, there is little to offer them in the way of~     evidence-based interventions to prevent or mitigate these problems.~      The investigators propose to conduct the first randomized trial to evaluate the efficacy of~     an intervention, the Cogmed Working Memory Program, in improving the neurodevelopmental~     outcomes of children with critical CHD after infant open-heart surgery. Children who meet~     eligibility criteria and who agree to participate will be randomly assigned to an~     intervention or control group. Children in the intervention group will complete 25 35-40~     minute sessions of Cogmed training, spread over for 5 weeks. This Program is a set of~     home-based, child-friendly, computerized activities. The control group will receive the~     standard of care for children with CHD. Children's scores on EF and related~     neurodevelopmental tests will be evaluated before the intervention group completes Cogmed~     training, at the conclusion of their training, and 3 months later. The latter assessment will~     indicate whether any gains in EF skills of the children in the intervention group are~     sustained after training. Parents and teachers will also complete questionnaires about~     children's EF, attention, and social behaviors to determine whether training affects~     behaviors of the intervention group at home and in school. The investigators will also~     identify the medical and surgical characteristics of children who benefit most from Cogmed~     training. This information will be helpful in targeting the intervention most efficiently in~     the future.~   "
41491|NCT03023631|"~     The goal of this clinical research study is to learn if Gardasil (the HPV vaccine) can~     prevent HPV infection and HPV-related disease when given to blood cancer patients who have~     received a stem cell transplant.~   "
41492|NCT03023618|"~     In this before and after study we will investigate the potential benefit on postoperative~     outcomes of a guided fluid therapy with a stroke volume optimization . The NICE protocol has~     been applied by means of EV1000 monitor and arterial waveform analysis ( Flotrac - Edwards).~     In the postoperative period overall complications, as well as exitus , will be analyzed and~     compared with those of a control group underwent the same surgical interventions, with a~     standard hemodynamic monitoring.~   "
41493|NCT03023605|"~     The purpose of this study is to analyze the clinical impact of an educational intervention on~     adherence to Clinical Practice Guidelines in an Emergency Department (ED), by using a~     standardized training, for improving diagnostic sensibility and reducing unnecessary scans,~     adverse effects and stays in the ED.~   "
41495|NCT03023579|"~     PURPOSE: The investigators estimated the reliability, standard error of measurement (SEM),~     and minimum detectable change (MDC) of the star excursion balance test (SEBT) in children~     with cerebral palsy (CP).~      METHODS: Eight children with CP (four boys and four girls, sixteen legs) participated in this~     study. Each child carried out the SEBT and was assessed by two examiners. To determine~     intra-rater reliability, the investigators calculated the intra-class correlation coefficient~     (ICC) model (3,3). The investigators also calculated the ICC model (2,3) to determine the~     inter-rater reliability.~   "
41496|NCT03023566|"~     The goal of this study is to evaluate safety and efficacy of Dotarem enhanced MRI in~     pediatric and neonatal population who are referred for contrast enhanced MRI at Phoenix~     Children's Hospital.~   "
41497|NCT03023553|"~     This study will examine the immune responses to the seasonal influenza vaccine in single~     cells of the nasal passages when compared with cells in circulating blood.~   "
41498|NCT03023540|"~     All randomised patients with Charcot-Marie-Tooth Type 1A (CMT1A) who completed the primary~     study CLN-PXT3003-02, i.e. treatment with PXT3003 or placebo, will be eligible to continue in~     the extension study CLN-PXT3003-03.~      Patients randomised to PXT3003 dose 1 or placebo in the primary study (CLN-PXT3003-02) will~     continue in the extension study on PXT3003 dose 1 (5 mL). Patients randomised to PXT3003 dose~     2 (5 mL) in the primary study (CLN-PXT3003-02) will continue in the extension study on~     PXT3003 twice dose 1 (2x5 mL).~      Patients previously randomised to PXT3003 dose 1 (5 mL) in the extension study~     (CLN-PXT3003-03) before September 18th 2017 will continue on dose 1 (5 mL). Patients~     previously randomised to PXT3003 dose 2 (5 mL) in the extension study (CLN-PXT3003-03) before~     September 18th 2017 will continue on PXT3003 twice dose 1 (2x5 mL).~   "
41499|NCT03023527|"~     This is an open-label, non-randomized Phase 1 study evaluating the role of two regimens:~      A) Nivolumab in combination with Pomalidomide and low dose dexamethasone and B) Nivolumab +~     Elotuzumab + Pomalidomide + dexamethasone in the treatment of relapse or refractory multiple~     myeloma patients.~      The study will be performed in 10 sites in Spain. First, the MTD for the Nivo-Pom-Dex~     combination will be determined using a 3+3 scheme. Once the MTD has been determined both~     Regimes (A and B) will be open for full accrual and patients will be included in an~     alternating way in both regimes simultaneously. In the case that an unacceptable toxicity was~     seen in the Lead-in phase (Nivolumab + Pomalidomide + low dose dexamethasone), the other~     phase would not be open.~      A safety analysis by an internal review committee will be performed once the first six~     patients included in the regimen B have completed the first two cycles.~      The main purpose of the study is to analyze the proportion of subjects, with refractory or~     relapsed multiple myeloma, receiving the combination Nivo-Pom-dex or Nivo-Pom-dex-Elo~     experience one or more haematological and non haematological SAE (grade 3 or higher).~      Additionally, other~      Research Hypothesis:~      The combination of nivolumab with pomalidomide and dexamethasone will demonstrate adequate~     safety and tolerability to permit further testing of these combinations in subjects with~     multiple myeloma. The addition of elotuzumab to nivolumab, pomalidomide and dexamethasone~     will not change the safety profile.~      Duration of Study:~      The study will remain open for enrolment for 15 months (estimated), or until the planned~     total number of 40 subjects is reached if this happens first.~      The follow-up of the last recruited patient will be up to 3 years, being the Final analyses~     performed 1,5 years after the last patient is included.~      Study Population:~      Male and female adult patients with Multiple Myeloma in first or subsequent relapses,~     previously exposed to both a proteasome inhibitor and a IMID (Lenalidomide). Patients may be~     exposed, relapsed or refractory to Lenalidomide.~   "
41500|NCT03023514|"~     Alpha-Lipoic Acid (ALA) is a natural molecule that can make a significant contribution to the~     success of embryo implantation phase, because it exerts, directly or indirectly, an~     immunomodulatory activity. ALA has the ability to regenerate antioxidants molecules that~     facilitate embryo implantation, and to stimulate the production of local mediators useful for~     implantation. This study is a prospective clinical trial and aims to evaluate the~     reproductive outcomes of Italian couples following oocyte donation fresh cycles when~     receiving per os tablets of lipoic acid. Indeed, the control group had only the standard~     treatment (vaginal progesterone), whereas the study group, in addition to that, received ALA~     (300 mg, 2 times per day) by oral route, from the day of donors oocyte pick up until the~     pregnancy test. If the childbearing occurred, treatment continued until the 8th week of~     pregnancy. Primary outcome of the study is the implantation rate while the positive hCG rate,~     the clinical pregnancy rate, the miscarriage rate and the live-birth rate are secondary~     outcomes .~   "
41501|NCT03023501|"~     The evidence regarding effects of pain modulator like gabapentin on postoperative pain after~     sleeve gastrctomy is sparse. Gabapentin has anti-hyperalgesic and postoperative~     opioid-sparing properties.This study will highlight the effectiveness of preoperative use of~     gabapentin for postoperative pain management in morbidly obese patients.~   "
41502|NCT03023488|"~     Aim of this study is to investigate the effects of increased intrarenal pressure during~     flexible ureteroscopy on renal blood flow.~      Patients undergoing flexible ureteroscopy (F-URS) and laser lithotripsy for kidney stones~     according to European Association of Urology (EAU) guidelines on Urolithiasis will be~     included in the study after having signed an informed consent form. The pre- and~     post-operative evaluation and management will be performed according to EAU Guidelines on~     Urolithiasis. Additionally, as a non-invasive test, bilateral renal power Doppler US will be~     performed to patients pre- and post-operatively. The pre-operative Doppler US will be~     performed 2 days prior to surgery and the post-operative Doppler US will be performed in the~     first 24 hours following surgery. The changes on blood flow in renal artery and arcuate~     artery will be recorded.~   "
41503|NCT03023475|"~     Endoscopic radial artery harvesting in coronary bypass surgery is routinely performed by the~     investigators. In this study, the investigators want to compare the MiFusion TLS2 (Endotrust~     GmbH, Germany) device to the LigaSure Maryland Jaw (Medtronic, USA). The vessel harvesting is~     performed in the standard fashion according to the institutional routine. The patients are~     randomized preoperatively to one of the devices. The proximal end of the radial artery will~     be preserved and deep-frozen for histological assessment. Endothelial integrity will be~     investigated using Hematoxylin-Eosin, CD31 and endothelial nitrogen monoxide synthase.~   "
41504|NCT03023462|"~     One of the most common complications after hernia repair is postoperative and chronic pain.~     TAP (transverse abdominis plain) block is a recommended multimodal method of reducing~     postoperative pain in laparoscopic and open inguinal hernia repair. The objective of this~     study is to determine whether the use of a perioperative echo guided unilateral TAP block has~     a superior effect on postoperative pain after laparoscopic inguinal repair compared to the a~     Quadratus Lumborum 3 Block with a long acting local anesthetic.~   "
41560|NCT03022734|"~     The purpose of this study is the increase of resection rate of primary cancer in rectal after~     short course radiotherapy without interrupt chemotherapy schedule during the period of~     chemotherapy. Radiation therapy is followed by additional chemotherapy to prevent the~     progression of systemic metastasis, and to reduce the incidence of rectal carcinoma including~     metastasis.~   "
41505|NCT03023449|"~     This study is a non-randomized, Phase 2 clinical trial designed to measure the cerebral blood~     flow (CBF) response to inhaled nitric oxide in acute ischemic stroke patients and healthy~     subjects. The monitoring is a 35 minute session during which cerebral hemodynamics will be~     monitored with both diffuse correlation spectroscopy (DCS) and transcranial doppler~     ultrasonography (TCD) while blood pressure, heart rate, cardiac output, respiratory rate, end~     oxygen saturation, and inhaled nitric oxide (NO)/nitrogen dioxide (NO2) concentration, are~     continuously monitored.~   "
41506|NCT03023436|"~     This study evaluates the survival benefit and safety of cytoreductive surgery(CRS) combined~     with HIPEC and chemotherapy in gastric cancer with peritoneal metastasis.~   "
41507|NCT03023423|"~     The purpose of the study is to compare the overall response rate (ORR) in non-small cell lung~     cancer (NSCLC) participants treated with daratumumab in combination with atezolizumab versus~     atezolizumab alone.~   "
41508|NCT03023410|"~     This study will attempt to draw relationships between the soft-tissue related complications~     contributing to early TKA revision and the loading and positional patterns from~     intraoperative tibial trial sensors. The data from the sensors may enable the surgeon to~     address such soft-tissue abnormalities that may otherwise be unknown during traditional total~     knee revision procedures. The utilization of sensors should in theory, help diagnose the~     potential causes attributing to soft-tissue imbalance and may lead to a decreased need for an~     all component revision. Furthermore, the economic implications from converting a total~     revision to a partial revision could have a profound effect to the patient and healthcare~     provider such as decreased rehabilitation regimes and opportunity for cost savings. Eligible~     revision patients who agree to participate will be followed for a period of 12 months~     following the revision procedure. Patient reported outcomes measures (PROM) such as the 2011~     Knee Society Score (KSS) and the Veterans Rand 12-Item Health Survey (VR-12) will be~     collected at baseline (pre-operatively) and at 6 weeks, 6 months and 12 months~     post-procedure. All outcomes will be scored to observe changes from baseline at 12-months.~     Cost-analyses of sensor-assisted revision TKA will be performed to include OR costs, facility~     and physician fees, as well as payments to post-acute collaborators such as SNFs, rehab~     hospitals, PT and home care providers. A quantitative analysis of commercial payer claims /~     usage data (e.g., CMS Medpar data) will be used to examine costs associated with traditional~     revision TKA procedures.~   "
41509|NCT03023397|"~     The purpose of this pilot study is to evaluate allergen-induced nasal airway inflammation~     following nasal application of Dermatophagoides farinae (Der f), or house dust mite, extract~     in e-cigarette users, cigarette smokers, and non-smokers.~   "
41510|NCT03023384|"~     Create a network of institutions in developing countries that will perform AML diagnosis,~     risk classification, treatment, supportive care and follow-up evaluation according to a~     common protocol and will register data using common clinical research forms (CRFs) in a~     single database and available on the internet.~   "
41511|NCT03023371|"~     The aim of this study is to establish a nation-wide cohort study of IgG4-related disease~     (IgG4-RD) in China.~      Methods: All the patients fulfilling diagnostic criteria of IgG4-RD (2011) would be enrolled~     from multi-centers around China. A online database system has been established.~      Endpoints: The primary endpoint is to investigate the clinical manifestations of Chinese~     IgG4-RD patients; the secondary endpoints including the demographic features,laboratory~     characteristics, immunological tests, imaging and pathological features, in addition, the~     treatment and prognosis of the disease.~   "
41512|NCT03023358|"~     The prognosis for Peripheral T cell lymphomas (PTCL) remains poor in comparison to B cell~     NHL. This is largely due to lower response rates and less durable responses to standard~     combination chemotherapy regimens such as CHOP. Whether CDOP plus Chidamide can improve the~     prognosis for PTCL.~   "
41513|NCT03023345|"~     The purpose of this study is to determine if trans-rectal microwave ablation of the index~     tumor of patients with low-risk prostate cancer is sufficiently precise and safe, using~     MRI-transrectal ultrasound image registration.~   "
41514|NCT03023332|"~     How do varying levels of participation in selecting self-management interventions (ranging~     from no input into the selection to selection based on need or preference) affect health~     risks and physical and mental health over time in family caregivers of persons with bipolar~     disorder? Caregivers will be randomized to: 1) a control group (no intervention); 2)~     education (usual care); 3) self-management intervention based on need (SM-need); or 4)~     self-management intervention of their preference (SM-preference).~   "
41515|NCT03023319|"~     This study will determine the maximum-tolerated dose (MTD) for oral bosutinib when used in~     combination with pemetrexed. The MTD is the highest dose of bosutinib with pemetrexed that~     can be given without causing severe side effects. This study will also test the safety of~     this combination and see what effects (good or bad) it has on participants and their cancer.~   "
41516|NCT03023306|"~     Female patients aged between 20 and 70 years, ASA physical status I-II, and scheduled for~     thyroidectomy under general anaesthesia will be enrolled in the study.~      Patients will be randomized to the preemptive group to receive an antiemetic regime the day~     before surgery or to the intraoperative group to receive the same antiemetic drugs in the~     same doses intraoperatively.~      In the operating room standard monitoring and a standardized anesthetic technique will be~     implemented in all patients. Nausea, vomiting, retching and PONV (cumulative) will be~     recorded immediately after extubation and six hourly thereafter for the first 24 hours. Pain~     scores assessed by VAS (verbal analogue scale) will be recorded at the same time points.~     Also, if patients received fluids and solid food by mouth.~   "
41517|NCT03023293|"~     The purpose of this study is to clarify the relationship between n-3 PUFA and irisin in~     regulating the glucose metabolism in GDM patients.~   "
41518|NCT03023280|"~     Symptomatic heterotopic gastric mucosa also known as cervical inlet patch (CIP) may be~     present in varying shapes and causes symptoms of laryngopharyngeal reflux like globus~     sensations, hoarseness and chronic cough. Unfortunately, argon plasma coagulation, standard~     treatment of small symptomatic CIP, is limited for large heterotopic gastric mucosa due to~     concerns of stricture formation. Therefore, the investigators aimed to investigate the effect~     of radiofrequency ablation (RFA), a novel minimal-invasive ablation method, in the treatment~     of large symptomatic CIP.~   "
41519|NCT03023267|"~     The current study will investigate the combination of the two modalities in a mixed-methods~     design, in order to provide comprehensive knowledge regarding the effects of family-centered~     MT during KC, on premature-infants' autonomic nervous system stability (measured by~     parasympathetic tone, physiological vital signs and behavioral states); Parents' anxiety~     levels; And parents' unique experiences of the intervention. Additionally, the study will~     analyze separately mothers and fathers to elucidate similar and different effects~   "
41520|NCT03023254|"~     To assess the benefit of the Avène hydrotherapy in subjects with pruritic plaque psoriasis~   "
41521|NCT03023241|"~     To identify new, simple and reliable biomarkers for bladder pain syndrome/interstitial~     cystitis (BPS/IC) for diagnosis of this disease.~   "
41522|NCT03023228|"~     A learner-centered diabetes survival skills self-management education program was provided to~     adults with uncontrolled diabetes in the hospital and generated preliminary evidence of~     impact on medication adherence and a trend toward reduction in hospital and emergency~     department admissions.~   "
41523|NCT03023215|"~     The goal of this behavioral research study is to learn if taking part in guided relaxation~     programs helps to reduce anxiety and pain during stereotactic breast biopsy. The study will~     also examine whether the guided relaxation programs change brain activity, heart rate, and~     blood pressure.~   "
41524|NCT03023202|"~     This study seeks to evaluate the clinical utility of the Precision Medicine Molecular Tumor~     Board, and to track patient outcomes.~   "
41525|NCT03023189|"~     Upper digestive bleeding. Upper gastrointestinal haemorrhage is a common cause of~     decompensated cirrhosis and is associated with a high mortality rate among cirrhotic~     patients. Its leading cause is the rupture of gastro-esophageal varices due to portal~     hypertension. In cirrhotic patients, the management of acute gastrointestinal haemorrhage is~     challenging as they often present with coagulation (or haemostasis abnormalities)~     abnormalities such as hyperfibrinolysis, especially when the cirrhosis is decompensated.~     Beyond life support measures, therapeutic modalities of upper gastrointestinal bleeding rely~     on both endoscopic and pharmacological interventions. Tranexamic acid (TA) is an~     antifibrinolytic that may help control the bleeding in this setting, as it showed an~     unquestionable benefit in other indications. TA has previously been studied in both upper~     gastrointestinal haemorrhage from any causes and in liver transplantation of cirrhotic~     patients. However, there is a lack of data to conclude on its effectiveness (or efficiency)~     in the early treatment of acute bleeding in cirrhotic patients.~      Investigators hypothesize that, when given early, TA would be beneficial for cirrhotic~     patients presenting with acute upper gastrointestinal haemorrhage , by controlling the~     haemorrhage, avoiding rebleeding episodes and reducing mortality within 5 days after its~     administration. Moreover, TA could prevent early cirrhosis complications (such as hepatic~     encephalopathy, sepsis and ascites liquid infection, hepatorenal syndrome), could reduce~     indications to transjugular portosystemic shunt (TIPS), shorten the length of stay in~     intensive care unit and the length of hospitalization, and decrease late relapses and~     one-year mortality.~   "
41526|NCT03023176|"~     This study will investigate markers, mechanisms and define general predictors for~     immunological health by comparing influenza vaccine responses in monozygotic and dizygotic~     twins.~   "
41527|NCT03023163|"~     The general population is aging, today 12% of the United States population is older than 65~     and it is estimated that by 2020 the number of people in the United States older than 65 will~     outnumber children younger than 5. As the general population ages, the spinal cord injury~     (SCI) population is also aging and it is estimated that 14% is older than 60. Although~     persons with SCI are living longer, life expectancy remains below that of the general~     population with cardiovascular and cerebrovascular diseases accounting for more than 25% of~     all deaths since 1995. Similar to findings in the general population, BP dysregulation may~     impact cognitive function, and investigators reported poorer performance on tasks of memory~     and attention processing in hypotensive individuals with SCI compared to a normotensive SCI~     cohort. Thus, it is imperative that investigators work to minimize the impact of cognitive~     deficits on these aspects of life quality in persons with SCI as they age. Therefore the~     goals of this study are: Study 1) to compare cardiovascular, cerebrovascular and cognitive~     function and fMRI between older individuals with SCI (50-75 years) and older age-matched~     controls and Study 2) to determine 3-5 year longitudinal changes in cardiovascular,~     cerebrovascular and cognitive function and fMRI in relatively young individuals with SCI~     (28-54 years) compared to relatively young age-matched controls.~   "
41528|NCT03023150|"~     This study will be the first study to use ischemic preconditioning (IPC) as an intervention~     to improve stroke rehabilitation. IPC is a well studied, well tolerated intervention which~     has been shown to improve regional blood flow, motor neuron excitability and muscle function~     in multiple patient groups and in young, healthy subjects. Because IPC targets three~     physiological systems which are all affected by stroke, we hypothesize that repeated bouts of~     IPC during the first days to months following stroke (when the majority of recovery occurs)~     will make traditional rehabilitation strategies more effective.~   "
41529|NCT03023137|"~     This study is part of a big one aiming to evaluate how lifestyle interventions during~     pregnancy affect obstetric results, neonatal metabolism and the intelligence of the offspring~     (study not yet completed). Data regarding obstetric and neonatal results were entered in~     NCT01409382, but we decided to split results in two for the sake of clarity.~      A cohort of women with early pregnancy losses without antiphospholipid antibodies was~     selected for two reasons. One is that these women follow strictly the recommendadtions. The~     second is that no medication has been shown to increase the rate of take-home babies in women~     with early miscarriages who test negative for antiphospholipid antibodies. We decided to~     focus on the fibrinolytic system because trophoblast migration and placental vasculogenesis~     and angiogenesis depend on plasmin-dependent extracellular matrix remodeling. Plasminogen~     activator inhibitor (PAI)-1 inhibits the generation of plasmin. Since both glucose and~     insulin increase PAI-1 synthesis, hyperglycemia itself, or by stimulating insulin production,~     reduces plasmin generation, which may impair placentation.~      Abnormalities in glucose metabolism may be also deleterious to embryos by causing epigenetic~     changes. Chromosomal abnormalities are considered an important cause of early pregnancy~     losses.~      Several lines of evidence lend support to the hypothesis that carbohydrate metabolism~     abnormalities contribute to the pathogenesis of recurrent early pregnancy losses. One is that~     of the pregnancies of the women with polycystic ovary syndrome, around 30 and 50% end with~     first-trimester miscarriages. Hyperinsulinemia is a prevalent feature of the syndrome, and~     interventions proven effective in reducing insulin levels, such as metformin, have been shown~     to reduce the rate of early miscarriages. The other is that patients with body mass index of~     ≥25 kg/m2 have significantly higher odds of early miscarriage, regardless of the method of~     conception.~      The investigator's hypothesis was that a balanced diet combined to regular exercise, by~     improving glucose homeostasis, would increase the take-home baby rate in women with~     consecutive early miscarriages. Moderate exercises are usually well tolerated not only by the~     mother, but also by the fetus, as indicated by tests of fetal well-being, including umbilical~     artery systolic to diastolic ratio.~   "
41531|NCT03023111|"~     Cutaneous leishmaniasis (CL) standard treatment is done with parenteral pentavalent antimony~     (Sbv) at the dose of 15-20mg / kg per day for 20 days. However, therapeutic failure has been~     described in up to 50% of patients, and the long period of 60 to 90 days required for healing~     of the ulcerated lesion indicate the need for alternative drugs. Currently the alternatives~     include other parenteral drugs such as pentamidine and amphotericin B, whose use is limited~     either by toxicity or because, as with Sbv, the parenteral route hinders adherence and~     regularity of treatment in the rural area. Recent studies by our group indicate that oral~     miltefosine is the most effective drug for the treatment of patients with CL caused by L.~     (V.) guyanensis and L. (V.) braziliensis in Brazil, with a cure rate of 71.4% and 75%~     respectively. CL pathogenesis is associated with intense inflammatory infiltrate and tissue~     damage. Previous trials associating GM-CSF to Sbv improved the cure rate of CL caused by L.~     (V.) braziliensis. The objective of this trial is to evaluate the therapeutic response to the~     use of miltefosine associated to GM-CSF in the treatment of CL caused by L. (V.) braziliensis~     in an endemic region in Bahia and Ceará, and by L. (V.) guyanensis in the Amazon region.~   "
41532|NCT03023098|"~     The purpose of this study is to determine whether the use of drug-eluting balloons is~     effective in the treatment of (re)stenosis in bypass vein grafts.~   "
41533|NCT03023085|"~     The objective of this study is to evaluate the safety and efficacy of BLI4700 as a bowel~     preparation prior to colonoscopy in adult patients.~   "
41534|NCT03023072|"~     The purpose of this study is to determine if the sponsor's Incontinence Product reduces~     patient exposure time to a wet and/or soiled incontinence pad.~   "
41535|NCT03023059|"~     From 3 large patient databases, patients diagnosed with AMD who have never taken~     levodopa(L-DOPA) containing medications have a mean age of diagnosis at 71 years. Patients~     who have been treated with L-DOPA containing medications have a mean age of diagnosis of AMD~     at 79 years.~      L-DOPA binds to GPR143 in the retinal pigment epithelium, and releases PEDF, which protects~     the retina and downregulates VEGF, which is the cause of neovascularization.~      The Investigators will evaluate the safety and tolerability of carbidopa-levodopa in patients~     with Neovascular AMD, and measure the effects on visual acuity and retinal abnormalities due~     to wet (neovascular) AMD.~      The Investigators will evaluate the safety and tolerability of carbidopa-levodopa in patients~     with Neovascular AMD who are already on treatment with anti-VEGF intraocular injections, and~     measure the effects on visual acuity, retinal abnormalities due to wet AMD, and document~     the number of anti-VEGF injections required during the study.~   "
41536|NCT03023046|"~     This phase II trial studies how well etoposide, prednisone, vincristine sulfate,~     cyclophosphamide, and doxorubicin (DA-EPOCH) works in treating patients with acute~     lymphoblastic leukemia or lymphoblastic lymphoma. Drugs used in chemotherapy, such as~     etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin, work in~     different ways to stop the growth of cancer cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading.~   "
41537|NCT03023033|"~     The goal of this proposed intervention study is to increase the proportion of HIV positive~     and HIV negative pregnant women who deliver in a facility, the proportion of HIV exposed~     infants (HEI) who receive nevirapine (NVP) within 48 hours of delivery, and the proportion of~     HEI who are bled for HIV polymerase chain reaction (PCR) deoxyribonucleic acid (DNA) testing~     within 8 weeks of age.~   "
41538|NCT03023020|"~     The study compares two lengths of medication therapy (a shortened versus a prolonged dual~     antiplatelet therapy) in order to prevent thrombus (blood cloth) formation after the~     successfully treatment for coronary heart disease with a drug covered stent (metallic tube).~      This comparison will be done in patients who, compared to the average patient, are more~     likely to suffer from complications on antiplatelet therapy (bleeding). Both durations are~     within the current medical recommendations. The aim of this study is to help improve further~     standard antiplatelet duration guidelines.~   "
41539|NCT03023007|"~     A non-randomized, mono-centric, prospective interventional study that will assess the~     efficacy of the loco-regional anesthesia PECS on the rate of chronic pain, 6 month after a~     patient will have either received a mastectomy or a mastectomy associated with axillary nodes~     dissection, and/or a reconstruction by prosthesis.~   "
41540|NCT03022994|"~     Recently it has been reported that a consistent percentage of the general population consider~     themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though~     they do not have CD or wheat allergy. This clinical condition has been named Non-Celiac~     Gluten Sensitivity' (NCGS). In a previous paper the investigators suggested the term~     'Non-Celiac Wheat Sensitivity' (NCWS), since it is not known what component of wheat causes~     the symptoms in NCGS patients, and the investigators also showed that these patients had a~     high frequency of coexistent multiple food hypersensitivity. Nowadays only few data are~     available on the histological characteristic of duodenal and rectal biopsies of NCWS~     patients. The researchers have just demonstrated a significant eosinophils infiltration of~     the duodenal and colon mucosa, and a significant infiltration of CD45+/CD3-CD14- cells in the~     rectal mucosa of NCWS patients upon wheat challenge, thus configuring a diffuse~     gastrointestinal inflammatory/immunologic pattern. The aims of the present study are: 1) to~     investigate the histological characteristics in duodenal and rectal biopsies between NCWS and~     irritable bowel syndrome (IBS) patients, and 2) to evaluate which site (i.e. duodenal or~     rectal) shows inflammatory/allergic features useful for NCWS histological diagnosis.~   "
41541|NCT03022981|"~     This study will have 2 parts: Pharmacokinetics (PK) Lead-in Phase and the Treatment Phase.~      The primary objective of the PK Lead-in Phase is to evaluate the steady state PK and confirm~     the dose of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in pediatric~     participants with chronic hepatitis C virus (HCV) infection.~      The primary objective of the Treatment Phase is to evaluate the safety and tolerability of~     SOF/VEL for 12 weeks in pediatric participants with chronic HCV.~   "
41561|NCT03022721|"~     The prospective observational study entitled Heidelberg Study on Diabetes and Complications~     is designed to Monitor the presence and development of diabetic complications in type 1 and~     type 2 diabetic patients, as well as pre-diabetics. Mail Goal is to detect new metabolic~     mechanisms or new risk factors for the development of diabetic complications in order to~     identify risk-subgroups. Non-diabetic controls will be enrolled for reference and comparison.~   "
41542|NCT03022968|"~     Recently revised Alzheimer Disease (AD) diagnostic1described nonamnestic presentations: 1/~     language presentation (logopenic progressive aphasia) 2/ visuospatial presentation (posterior~     cortical atrophy or PCA) and 3/ executive dysfunction. AD pathological changes may precede~     the clinical diagnosis of dementia of AD type for a while2. Biomarkers have been developed:~     biomarkers of brain amyloid-beta (Aß) (CerebroSpinal Fluid CSF concentration ßamyloid,~     molecular imaging with amyloid targeted PET ligands), biomarkers of neural degeneration (MRI~     hippocampal volume, regional metabolism as assessed by PET with [18F]-FDG) and may be used to~     made early detection of the neuropathology associated with AD Even if CSF biomarkers (tau,~     p-tau and β amyloïd are interesting to improve diagnosis of AD, they cannot provide~     topographic information. PET tau imaging seems to be promise to evaluate quantitative and~     spatial assessment of tau lesions both in AD and fronto-temporal lobar dementia.~      The hypothesis of the research is that it exists a different regional pattern of tracer~     retention across brain regions according to clinical symptoms : temporal for logopenic~     aphasia and occipital for posterior cortical atrophy.~   "
41543|NCT03022955|"~     This is a randomized, controlled, 2x2 cross-over study to assess the effects of cocoa solids~     on gastrointestinal transit, post-prandial sensation and well-being. Additionally functional~     brain imaging will be applied to identify regions of brain that are activated or inactivated~     by cocoa ingestion. Healthy subjects will be recruited and randomized to receive either dark~     chocolate (70% cocoa solids) or white chocolate (0% cocoa solids) in addition to their normal~     diet in randomized order. Reference standard methodology will be applied to measure gastric~     emptying, oro-caecal and colonic transit time. Dark and white chocolate (100g, ~500kcal, ~50%~     fat) will be consumed with radio-opaque markers on three consecutive days. On the third day~     chocolate ingestion will be followed by measurements of postprandial brain activity using~     FDG-Positron Emission Tomography. Additionally colonic transit will be assessed based on the~     number and distribution of radio-opaque markers in the colon. On the fourth day gastric~     emptying and oro-caecal transit time will be assessed by scintigraphy after ingestion of a~     dark or white chocolate mousse test meal (both 150g, ~500kcal, ~50% fat). During both~     interventional studies pre- and post-prandial satiety and dyspeptic symptoms, well-being and~     mood will be recorded. Additionally, validated questionnaires will assess digestive comfort~     and well-bring at the end of each study day. These results will deliver comprehensive~     information about the effects of cocoa on gastrointestinal transit and sensation.~   "
41544|NCT03022942|"~     To evaluate the acute and chronic effects of costal mobilization techniques and diaphragmatic~     release in chest cavity kinematics, diaphragmatic mobility and functional capacity in~     patients with chronic obstructive pulmonary disease~   "
41545|NCT03022929|"~     Inappropriate antibiotic use is a major public health concern. Excessive exposure to~     antibiotics results in emergence and spread of drug-resistant bacteria, potentially avoidable~     adverse drug reactions, and increased healthcare utilization and cost. As antibiotic~     prescribing in emergency departments and urgent care centers remains unchecked, national~     professional organizations including the Infectious Diseases Society of America (IDSA) and~     the Society for Healthcare Epidemiology (SHEA), and an Executive Order from the President of~     the United States, recommend expansion of antimicrobial stewardship to these ambulatory care~     settings. The goal of antimicrobial stewardship is to effectively promote judicious~     antibiotic use in all healthcare settings, yet stewardship programs have not achieved their~     potential in terms of either reach or effectiveness. Reach has been limited by implementation~     mostly in inpatient settings; at the same time, recent critical experiments in behavioral~     science suggest that the effectiveness of existing stewardship programs could be greatly~     augmented through inclusion of behavioral nudges, benchmarked audit and feedback, and~     peer-to-peer comparisons.~   "
41546|NCT03022916|"~     A recent publication using cadaver nails suggests that Jublia application has a negative~     effect on nail polish texture.~   "
41547|NCT03022903|"~     This research study will evaluate the safety and efficacy of using blue light photodynamic~     therapy (PDT) for treating toenail fungal infections.~   "
41548|NCT03022890|"~     The Specific Aims of this treatment development research are:~      To conduct a pilot randomized clinical trial (n = 40) of hatha yoga vs. a health education~     group (attention control) for persons with chronic pain who are taking methadone maintenance~     therapy (MMT) or bupreonorphine (BUP) for opioid use disorder maintenance treatment.~     Participants will be enrolled in the active intervention for 3 months, and then be followed~     for 6 months afterwards. Investigators' aims are:~        1. To assess feasibility and acceptability of both the yoga class and the health education~          control group. Investigators will assess credibility of the assigned intervention and~          expectancy for improvement for both groups at baseline, program satisfaction following~          program participation, participant adherence (class attendance rate and amount of home~          practice corresponding to assigned study arm), and instructor fidelity to the manuals.~          Investigators will conduct structured interviews following program participation to~          understand specific aspects of both programs considered attractive, useful, or not~          useful; we will solicit suggestions for improvements as well.~        2. To assess safety, investigators will track all adverse events in a structured fashion.~          Investigators do not expect to see any serious adverse events definitely or probably~          related to study participation.~        3. To assess feasibility of research procedures, investigators have benchmarks for~          recruitment rate, retention for study assessments, and reliability of instructor~          fidelity measures.~   "
41549|NCT03022877|"~     In the proposed project the investigators want to assess whether the approach of the~     post-conditioning by Levosimendan in patients with acute STEMI is safe and reproducible, can~     be used with a positive influence on the outcomes with respect to myocardial damage, cardiac~     left ventricular remodeling, myocardial function, the occurrence of cardiac events and~     quality of life.~   "
41550|NCT03022864|"~     Postoperative pain is an ideal model for study on acute pain changing into chronic pain. The~     functional imaging of magnetic resonance can reflect the extent and character of pain exactly~     and the structural imaging of it can be a sign of the change. By analyzing fMRI results of~     participants with acute pain and following them up for three months, the investigators expect~     to find objective indicators for acute pain changing into chronic pain and give preventive~     analgesia for people with high risk of chronic pain.~   "
41551|NCT03022851|"~     This study aims to investigate safety and efficacy of Occlutech® AFR device in patients with~     severe pulmonary hypertension (PH).~   "
41553|NCT03022825|"~     This is a Phase II, open-label, single-arm, multicenter study of intravesical BCG plus~     ALT-803 in patients with BCG unresponsive high grade non-muscle invasive bladder cancer~     (NMIBC). All patients treated in the study will receive via a urinary catheter in the~     bladder, BCG plus ALT-803 weekly for 6 consecutive weeks (initial induction treatment~     period). After the first disease assessment, eligible patients will receive either a 3-week~     maintenance course or a 6-week re-induction course (second treatment period) at Month 3.~     Eligible patients will continue to receive maintenance treatment in the third treatment~     period at Months 6, 9, 12, and 18. The study duration is 24 months.~   "
41554|NCT03022812|"~     Neck pain is fourth among the most common conditions worldwide associated with longer periods~     of living with disability. Annually, about 30 000 people in Sweden undergo a whiplash trauma~     (WAD), and half of those individuals will develop chronic problems with high costs for the~     individual and society. Evidence for chronic WAD treatment is scarce, although neck-specific~     training at a physiotherapy clinic (2 times a week for 3 months) has demonstrated good~     results. A more efficient, flexible rehabilitation with reduced waiting times and lower costs~     is needed, ideally replacing lengthy on-site treatment series by health care providers.~     Internet-based care has proven to be a viable alternative to personal care meetings for a~     variety of diseases and interventions, but studies are lacking on Internet-based~     interventions for individuals with chronic neck problems. The purpose of this study is to~     investigate if A) neck-specific training delivered through Internet-based care differs from~     B) a longer series of treatments at a physiotherapy clinic regarding, e.g., work ability,~     sick-leave and disability. This prospective, randomized study involves 140 participants.~     Measurement is done at baseline, 3 months (end of treatment), and 15 months (12 months after~     end of treatment in the study) and will include ratings of work ability, sick-leave, work~     presenteeism, disability, pain, health, satisfaction with care, quality of life, and~     cost-effectiveness. The study results may contribute to the development of a more effective~     rehabilitation, flexible and equal care, shorter waiting times, increased availability and~     lower costs for health care and society. The program can be implemented on a broader scale in~     neck pain patients.~   "
41555|NCT03022799|"~     This first in human, single-center, randomized, placebo-controlled, double blind, sequential~     group Phase 1 study in healthy subjects will be conducted to evaluate the safety,~     tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) following the escalation of~     single and multiple doses of KM-819.~      The study will consist of 2 parts. In Part A, up to 5 cohorts of young adult male subjects,~     and 1 single dose cohort of elderly male or post menopausal female subjects will receive~     escalating single doses of KM-819. The food effect will be investigated in one of the single~     dose cohorts of young adult male subjects, who will be crossed-over to the fed condition.~     Once the dose level is selected for the crossed-over to the fed condition and elderly~     subjects, the protocol will be amended to specify the dose level. In Part B, up to 4 cohorts~     of healthy young adult male subjects and 1 multiple dose cohort of elderly male or post~     menopausal female subjects will receive escalating multiple doses of KM-819. Part B will be~     conducted after completion of all cohorts of young adult male subjects in Part A.~      Dose escalation to the next level will be determined using safety, tolerability, and PK data~     of the previous cohort.~      Part A, Single Ascending Dose (SAD) Up to 40 healthy young adult male subjects and 8 healthy~     elderly male or post menopausal female subjects will be enrolled and randomized to receive~     either KM-819 or placebo.~      Each of the 5 dose escalation cohorts consists of 8 healthy young adult male subjects; 6~     subjects will receive 10, 30, 100, 200, or 400 mg of KM-819 and 2 subjects will receive~     placebo. In each single dose cohort, dosing of subjects will be sentinel, i.e., 2 subjects~     will be dosed on the first day (1 subject will receive active treatment and 1 subject will~     receive placebo) and the remaining 6 subjects will be dosed at least 24 hours after the first~     2 subjects.~      Cohorts will be dosed sequentially with escalating doses. One of the cohorts will be~     crossed-over to the fed condition to assess the effect of food as decided by Investigator and~     Sponsor during the study after completion of the 2nd dose cohort (30 mg).~      Eight elderly male or post-menopausal female subjects will be enrolled into an additional~     cohort; 6 subjects will receive KM-819 at a dose level not exceeding the highest dose tested~     in the young adult male cohorts and 2 subjects will receive placebo.~      Part A consists of a Screening period of up to 28 days, and a 3 day Confinement period when~     subjects are hospitalized for study activities. Subjects are required to return for~     outpatient visits on Day 4, 7 and for the Follow up Visit on Day 14. The cohort that~     crossed-over to the fed condition will undergo the same procedure up to the Outpatient Visit~     on Day 4. Subjects will be confined for 3 days for the second time, and are required to~     return for outpatient Visit 5 (Day 4), Visit 6 (Day 7), and for a Follow up Visit 7 (Day 14).~      Part B, Multiple Ascending Dose (MAD) Up to 32 healthy young adult male subjects and 8~     healthy elderly male or post menopausal female subjects will be enrolled and randomized to~     receive either KM-819 or placebo.~      Each of the 4 dose escalation cohorts consists of 8 healthy young adult male subjects; 6~     subjects will receive 30, 100, 200, or 400 mg of KM-819 once a day (QD) for 7 days and 2~     subjects will receive placebo. Cohorts will be dosed sequentially with escalating doses.~      Eight elderly male or post-menopausal female subjects will be enrolled into an additional~     cohort; 6 subjects will receive KM-819 at a dose level not exceeding the highest dose tested~     in the young adult male cohorts and 2 subjects will receive placebo.~   "
41556|NCT03022786|"~     Explore the unmet needs of patients admitted to the hospital for severely inflamed skin of~     the lower legs, often described as 'bilateral cellulitis. These patients usually have~     intractable lower extremity edema, stasis dermatitis and sometimes allergic contact~     dermatitis rather than an infectious process; readmission is common. Investigators will~     create patient and provider education materials to align dermatological, home health, and~     other resources and measure reduction in hospital re-admission rate and length of stay.~   "
41557|NCT03022773|"~     The purpose of this study is to understand the role of nutrition and its effects on the eye~     and other tissues. The investigators propose to study this by validating and correlating~     various non-invasive measurement methods of carotenoid concentrations in the human eye and~     skin tissue.~      A secondary objective is to correlate blood levels of carotenoids on a sub-set of~     participants.~   "
41558|NCT03022760|"~     The aim of this project is to develop a model for return to work (RTW) for patients sick~     listed due to stress related mental disorders, which takes into account each patient's~     specific situation; includes the workplace, and is well adapted to the Swedish primary care~     setting.~      In late 2016, general practitioners (GPs) and rehabilitation coordinators at both public and~     private primary care centers will be offered a one-day training about work and workability~     for patients with stress related mental disorders. Also, the participants will be trained in~     a specific method that includes the patient's employer early in the rehabilitation process~      The project has a quasi-experimental and longitudinal design. The intervention will be~     conducted on 15 different primary care centers, which will be matched with a comparison~     group. Return to work for 500 patients will be analyzed using registry data, 6, 12 and 18~     months after sick-listing. The hypothesis is that patients who are sick-listed at primary~     care centers that completely or partially implemented the specific method on average will~     return earlier to work than patients sick-listed at primary care centers that did not~     implement the method.~      Alongside studying if the intervention has an effect on the patients' RTW over time, the~     investigators aim to investigate the mechanisms explaining the effects and the individual and~     organizational level (primary care units) circumstances necessary for these mechanisms to be~     triggered. To gain deeper knowledge about mechanisms and context, the investigators will~     conduct interviews with the treatment staff and collect registry data about the primary care~     units.~   "
41559|NCT03022747|"~     The study will investigate, in children with acute lymphoblastic leukemia during maintenance~     treatment, if addition of allopurinol to conventional oral 6-mercaptopurine and methotrexate~     therapy, affects erythrocyte concentrations of 6-thioguanine and 6 methylmercaptopurine. The~     effect on hematological and liver toxicity parameters in blood will also be investigated as~     well as clinical toxicity.~   "
41562|NCT03022708|"~     This is a multi-center prospective, single-arm, non-randomized, open label study to assess~     feasibility of the Xeltis Bioabsorbable Pulmonary Valved Conduit in subjects requiring Right~     Ventricular Outflow Tract correction or reconstruction due to congenital heart malformations.~   "
41564|NCT03022682|"~     Obesity affects over one third of US adults (>72 million, with BMI ≥30 kg/m2), and the~     proportion of US adults with BMI ≥40 kg/m2 has doubled in the last 20 years. Obesity is~     associated with increased mortality through its linkage to comorbidities including diabetes,~     hypertension, dyslipidemia, osteoarthritis, sleep apnea and psychosocial disturbances. Given~     its prevalence, impact on morbidity and mortality, and economic cost, limiting the spread of~     obesity and its consequences is one of the most important problems of our time.~   "
41565|NCT03022669|"~     The purpose of this study is to determine whether text messages/messaging (TM) or a mobile~     application (app), compared with an educational website-control provided to all Veterans, can~     improve adherence to antiplatelet therapy among patients following acute coronary syndrome or~     percutaneous coronary intervention (ACS/PCI).~   "
41566|NCT03022656|"~     Brace treatment is the most effective non-surgical method for the treatment of Adolescent~     idiopathic scoliosis (AIS). The goal of bracing is to stop the curve progression during the~     high risk period of the adolescent growth spurt. A spinal brace is a hard plastic shell with~     pressure pads installed inside the liner to provide mechanical support to the curvature of~     the spine. It is a big commitment for adolescents to wear a brace because it is physically~     restrictive, uncomfortable and draws unwanted attention. Therefore, it is very important to~     make the brace treatment as effective as possible to get patient buy-in to compromise their~     lifestyle by wearing a brace. Patients' belief in the treatment outcomes is also a factor to~     attain their compliance.~      This randomized clinical study will investigate if the effectiveness of brace treatment can~     be maximized by combining ultrasound imaging assistance during brace design with the smart~     brace to automatically maintain corrective brace pressures at the optimum level during the~     whole treatment period.~   "
41567|NCT03022643|"~     Behavioral and biological rhythms are essential for health. No study evaluated behavioral~     rhythm or rhythm regulation in chronic pain and how this impacts functioning. The objective~     of this study is to gather preliminary data, focusing on the role of behavioral rhythms in~     the cardinal clinical symptoms of chronic pain (i.e., sleep, fatigue, and mood).~     Additionally, this study will provide preliminary data for the feasibility and acceptability~     of the therapeutic approach aiming to strengthen behavioral rhythms for patients with chronic~     pain.~   "
41568|NCT03022630|"~     The purpose of this study is to evaluate, through a randomized controlled trial, the impact~     of integrated comprehensive palliative care services on time to first hospital readmission~     and other hospital utilization outcomes, quality of life, and patient/caregiver outcomes. The~     intervention includes comprehensive, standardized palliative care services for adult~     hepatology cirrhosis patients for which prognosis is poor.~   "
41569|NCT03022617|"~     Psoriasis vulgaris is a common inflammatory condition of the skin that results in scaly red~     itchy plaques. In addition to affecting the skin, psoriasis can also cause disease in the~     finger and toe nails. The most characteristic nail findings associated with nail psoriasis~     are nail pitting, onycholysis with a rim of erythema, and oil spots. Because nail psoriasis~     causes a substantial disease burden for patients, it is critical that safe and effective~     treatments are found for this specific type of psoriasis. Unfortunately, nail psoriasis is~     often difficult to treat.~      Apremilast is an orally available small molecule inhibitor of phosphodiesterase 4 (PDE4) that~     is FDA approved for the treatment of psoriasis and psoriatic arthritis. Apremilast has shown~     promising results for treating psoriatic arthritis and nail disease; however more data is~     needed regarding its effect on nail psoriasis (Kavanaugh, et al). We hypothesize that~     apremilast will prove to be highly effective in treating nail psoriasis. We propose to~     conduct an open label clinical trial to investigate the efficacy and tolerability of~     apremilast in treating nail psoriasis, where we will follow the package insert guidelines for~     treating patients with apremilast.~   "
41570|NCT03022604|"~     This study is assessing the effects of a pre-workout dietary supplement.~   "
41571|NCT03022591|"~     This is a retrospective chart review. The purpose of this study will be to look at the~     outcomes of twin pregnancies diagnosed with short cervix along with the intervention~     (treatment) that these patients received.~   "
41572|NCT03022578|"~     You are being asked to take part in this study because you have glioblastoma or anaplastic~     astrocytoma (AA) that has relapsed (come back) after treatment and the study doctor thinks~     that it is in your best interest to receive chemotherapy for the disease. Additionally, the~     study doctor thinks it may be in your best interest to also have a surgical procedure called~     laser interstitial thermal therapy (LITT). LITT is a minimally invasive (using small~     incisions) surgery method that uses lasers to destroy tumor cells.~      For the procedure, the study doctor uses the NeuroBlate system to perform LITT in combination~     with MRIs and software models to focus the lasers on affected brain cells.~      The goal of this clinical research study is to learn if the NeuroBlate system in combination~     with lomustine can help to control glioblastoma or anaplastic astrocytoma (AA) that has~     returned after treatment. The safety of the combination will also be studied.~      This is an investigational study. The NeuroBlate system is FDA approved and commercially~     available for different types of brain surgery. Lomustine is FDA approved and commercially~     available for the treatment of brain tumors. LITT using the NeuroBlate System in combination~     with lomustine for the treatment of glioblastoma is investigational.~      The study doctor can describe how the study drug and procedure are designed to work.~      Up to 34 participants will be enrolled in this study. All will take part at MD Anderson.~   "
41573|NCT03022565|"~     This proof-of-concept study will evaluate the ability of vorinostat to induce the~     transformation of Class 2 uveal melanoma cells into a cell phenotype that resembles normal~     melanocytes.~   "
41574|NCT03022552|"~     This prospective observational cohort study, will investigate the platelet phenotype,~     platelet genetic composition, and role of platelets as effector cells in women with~     myocardial infarction (MINOCA or MI-CAD) and controls. This study, which will take place at~     NYU and Bellevue Medical Center, may have concurrent enrollment with the HARP Main Imaging~     (NCT02914483) and HARP Stress Ancillary Studies (NCT02270359). Additionally, a group of age~     and race matched disease controls 'CATH-NOCA' composed of women with stable angina referred~     for cardiac catheterization, will be enrolled. Blood obtained during the initial~     catheterization, 2 months post-MI, and following the stress study (for those participants~     enrolled in the stress study) will be utilized for platelet testing.~   "
41575|NCT03022539|"~     Radiotherapy (combined with chemotherapy) is commonly used in the curative treatment of~     pelvic tumours, such as in cervical, vulvar and anal cancer. In these patients, cure rates~     are high but may be associated with significant treatment-related toxicities, especially~     dermatologic, gastrointestinal, genitourinary and hematologic toxicity.~      Accurate treatment planning and dose delivery is essential for radiotherapy in order to be~     effective in terms of local tumour control and to reduce radiation-induced side effects.~     However, accuracy is challenged by tumour and organ motion from fraction to fraction~     (interfraction movements). At present, radiotherapy treatment planning is typically performed~     on one planning-CT scan which is performed before the start of the treatment. However,~     interfraction set up variations and organ motions can lead to differences between the~     calculated dose distribution on the planning-CT and the radiation dose actually received by~     the tumour and normal organs (actual given dose). Current photon radiotherapy of the pelvic~     area is relatively insensitive to these changes and margins from CTV to PTV ensures an~     adequate dose coverage of the tumour area. Despite newer techniques in photon therapy, like~     intensity modulated radiotherapy (IMRT), critical organs still receive a substantial amount~     of dose leading to clinically relevant acute and late side effects. With proton beam therapy,~     the amount of radiation dose to the organs at risk can be significantly reduced.~      For proton beam therapy (PBT) however, knowledge of tumour and organ motion will be more~     important. The major potential advantages of PBT for tumours in the pelvic area in terms of~     prevention of radiation-induced side effects are challenged by differences in bladder volume,~     rectal filling and air gaps especially in the small bowel, sigmoid and rectum. Setup errors~     and organ motion cause geometric displacement of the tumours and normal tissues, which~     deteriorates the dose gradients from target volume to normal tissue. Furthermore, it can~     result in changes in tissue densities in the beam path, which can alter the position of the~     Bragg peaks, in turn leading to distorted dose distributions, usually manifesting as~     significant local under and/or over dosage.~      In this study, the investigators want to evaluate the impact of inter and intrafractional~     tumour and organ motion on photon and proton radiotherapy treatment planning in order to~     create robust intensity modulated photon- and/or proton treatment plans (IMRT, IMPT) with the~     final aim to lower treatment related toxicity.~      Objective: To explore the extent of inter- and intrafraction anatomical changes of the tumour~     and surrounding normal tissues, throughout the full course of treatment, and to subsequently~     assess the impact of these changes on the nominal planned dose. This information is required~     to design robust treatment plans (photon and/or proton) that will ensure optimal local tumour~     control while reducing toxicity.~      Study design: Pilot-study (40 patients).~      Study population: Patients with cervical, vulvar or anal cancer, who are planned for~     radiotherapy (with or without chemotherapy) with curative intent.~      Intervention (if applicable): Not applicable.~      Main study parameters/endpoints: Robustness parameters (homogeneity index; coverage of~     clinical target volume), dose to organs at risk (OARs), such as the small bowel, rectum,~     bladder and bone marrow.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: During the radiotherapy treatment course, patients will undergo weekly repeat~     planning CT scans without contrast agents in order to evaluate the impact of intra and~     inter-fraction tumour and organ motion.~      The additional radiation dose of these 5 extra CT's is relatively low (5 x 8 mSv, plus 1 x 22~     mSv for the 4D CT scan) in relation to the therapeutic radiation dose (50.4-85 Gy). The risks~     are therefore negligible and the burden is low.~   "
41576|NCT03022526|"~     The purpose of this pilot prospective randomized control trial is to compare the initiation~     of labor epidural analgesia by combined spinal epidural vs. epidural for the influence on~     risk for postpartum depression symptoms. Investigators will randomize women to the receipt of~     CSE or E during labor, after measuring baseline psychological, psychosocial, and~     psychophysical factors related to pain and depression. The immediate research goals are to~     understand whether the association between labor pain and PPD is modifiable through the use~     of tailored anesthetic techniques.~   "
41577|NCT03022513|"~     Recently it has been reported that a consistent percentage of the general population consider~     themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though~     they do not have CD or wheat allergy. This clinical condition has been named Non-Celiac~     Gluten Sensitivity' (NCGS). In a previous paper the investigators suggested the term~     'Non-Celiac Wheat Sensitivity' (NCWS), since it is not known what component of wheat causes~     the symptoms in NCGS patients, and the investigators also showed that these patients had a~     high frequency of coexistent multiple food hypersensitivity. The clinical picture of NCWS is~     characterized by combined gastrointestinal (bloating, abdominal pain, diarrhea and/or~     constipation, nausea, epigastric pain, gastroesophageal reflux, aphthous stomatitis) and~     extra-intestinal and/or systemic manifestations (headache, depression, anxiety, 'foggy mind,'~     tiredness, dermatitis or skin rash, fibromyalgia-like joint/muscle pain, leg or arm numbness,~     and anemia). Nowadays no data are available on the characteristic of 'rheumatologic' symptoms~     of NCWS patients. Therefore, the aims of the present study are: 1) to investigate the~     prevalence of fibromyalgia-like joint/muscle pain in NCWS patient, 2) to search for possible~     ultrasonographic alterations (i.e. synovitis) of hands and feet joints of NCWS patients, and~     3) to evaluate modification of fibromyalgia-like joint/muscle pain in NCWS patients after a~     gluten free diet period of almost 6 months.~   "
41578|NCT03022500|"~     To understand efficacy of Durvalumab(MEDI4736)+ Tremelimumab in Metastatic/relapsed pulmonary~     sarcomatoid carcinoma~   "
41579|NCT03022487|"~     This is a prospective open label single blinded multi-centre observational study involving a~     study group of patients already undergoing implantable cardioverter-defibrillator~     (ICD)(including Cardiac resynchronisation therapy device (CRT-D)) implant. A standard~     30-minute electrophysiological (EP) cardiac stimulation protocol will be performed at the end~     of the ICD implant at baseline. This EP test will be performed whilst measuring a 12-lead ECG~     and will be correlated with event rates to establish their effectiveness in predicting~     arrhythmia risk. The minimum follow up period should be 18 months and maximum of 3 years,~     which is how long the study is funded for. This study is not randomised as all study patients~     will be receiving the EP study performed at baseline. A minimum of 440 patients will be~     recruited to document event data at standard clinical ICD follow up intervals - equating to a~     maximum of 6 visits. Blinding will be maintained at the core lab were the ECG analysis will~     be performed by a nominated researcher who will not have details of patient health status.~   "
41580|NCT03022474|"~     Early life interventions for childhood obesity may provide substantial benefits. Most~     existing studies aimed at school children have reported limited effectiveness, however few~     have targeted preschool children. This study aimed to pilot procedures for a multifaceted,~     culturally appropriate intervention for preschool children and to provide a preliminary~     assessment of effectiveness of the intervention.~   "
41581|NCT03022461|"~     The purpose of this clinical investigation is to report the long term survival and incidence~     of adverse events in the patients who were implanted with HM3 in the CE Mark Study and~     continue to be ongoing with the HeartMate 3 LVAS after the CE Mark Study 2 year follow-up.~      The study will be a single arm, prospective, multi-center, non-blinded and non-randomized~     study, intended to report on the long term use of the HeartMate 3 LVAS in those patients that~     completed the 2-year follow-up in the HeartMate 3 CE Mark study.~   "
41582|NCT03022448|"~     The aim of the non-interventional study is to prospectively collect and analyze data on the~     geriatric assessment of patients undergoing systemic 1st line therapy with trabectedin with~     focus on patients who have been assessed by the treating physician as being unsuited to~     receive standard chemotherapy with anthracyclines and / or ifosfamide.~      Trabectedin will be used according to the local SmPC. Modification of the treatment schedule~     should follow the standard medical practice at the discretion of the treating physician and~     is not part of this Observational Plan.~   "
41583|NCT03022435|"~     This study will investigate markers, mechanisms and define general predictors for~     immunological health by comparing influenza vaccine responses in monozygotic and dizygotic~     twins.~   "
41584|NCT03022422|"~     This study will investigate markers, mechanisms and define general predictors for~     immunological health by comparing influenza vaccine responses in monozygotic and dizygotic~     twins.~   "
41585|NCT03022409|"~     This biomarker window basket study has been designed with the intent of assessing the effects~     of different agents in both tumour tissue and peripheral samples to further inform optimal~     combinations of DDR agents with immuno-oncology (IO) therapies and the suitable sequencing~     and relative timing of these therapies.~      In the first instance 2 DDR agents will be assessed as monotherapy. Based on emerging data~     additional arms may be incorporated to evaluate other DDR agents and/or DDR and immunotherapy~     agents in combination or in series.~      The primary objective of the study is to investigate immune activation due to DDR inhibition~     by monitoring the induction of TH1/IFNg response in tumours of patients treated with study~     investigational agent(s)~   "
41586|NCT03022396|"~     This study will investigate response to influenza vaccines in monozygotic and dizygotic twins~     of different ages.~   "
41587|NCT03022383|"~     To determine optimal cut-off value for the TopQ cut-off on the DRI OCT Triton plus~   "
41588|NCT03022370|"~     This study evaluates whether the behavioural/structural interventions of Stepping Stones and~     Creating Futures can reduce the incidence of intimate partner violence in urban informal~     settlements amongst young people. Half the participants will receive the interventions, while~     the other half will be in a control wait-list, only receiving the intervention after final~     data collection.~   "
41589|NCT03022357|"~     Prospective observational study to compare sensitivity of 3T functional Magnetic Resonance~     Imaging (3T fMRI) at diagnosing Parkinson's Disease (PD) against the benchmark DaTScan~     diagnostic test and clinical diagnosis at follow up.~   "
41590|NCT03022344|"~     However, there is only very sparse information regarding the atherosclerotic burden and~     cardiovascular biomarkers in the early stages of type-2 diabetes, as the vast majority of~     studies have concerned diabetes populations with more than 5 years average diabetes age or~     high-risk subgroups, who at inclusion already had atherosclerotic disease manifestations.~      Consequently, this study aims on evaluating the occurrence of early-stage subclinical~     atherosclerosis in newly diagnosed type-2 diabetes with special emphasis on coronary plaque~     characteristics by modern imaging techniques. These findings will be compared to the~     functional status of various peripheral arterial segments and biomarkers in the~     cross-sectional part of this study. The 5-year follow-up study intends to describe~     relationships between these selected measures for general atherosclerotic involvement and the~     progression of the coronary atherosclerotic burden by contemporary techniques.~   "
41591|NCT03022331|"~     The term 'aortitis' refers to inflammation of the aorta. Aortitis is known to occur in a~     variety of vasculitides and connective tissue diseases, such as giant cell arteritis (GCA),~     Takayasu arteritis (TAK), rheumatoid arthritis, and spondyloarthropathies, among others. This~     study will establish a longitudinal cohort for these diseases.~   "
41592|NCT03022318|"~     From 3 large patient databases, patients diagnosed with AMD who have never taken~     levodopa(L-DOPA) containing medications have a mean age of diagnosis at 71 years. Patients~     who have been treated with L-DOPA containing medications have a mean age of diagnosis of AMD~     at 79 years.~      L-DOPA binds to GPR143 in the retinal pigment epithelium, and releases PEDF, which protects~     the retina and downregulates VEGF, which is the cause of neovascularization.~      The Investigators will evaluate the safety and tolerability of carbidopa-levodopa in patients~     with Neovascular AMD, and measure the effects on visual acuity and retinal abnormalities due~     to wet (neovascular) AMD.~   "
41593|NCT03022305|"~     The investigators hypothesize that neuromuscular realignment of the pelvis bones will be more~     effective in improving range of motion and torque production at the shoulder joint than~     traditional exercises for improving hip internal rotation and adduction range of motion.~   "
41594|NCT03022292|"~     A study investigating the ability of OCTA imaging technology to identify and analyze~     untreated type 1, 2, and 3 neovascular membrane lesions in treatment naive patients with~     exudative macular degeneration, as well as investigating the ability of the OCTA imaging~     technology to evaluate the treatment outcomes of Intravitreal Aflibercept Injection in~     neovascular lesions associated with macular degeneration.~      This study is utilizing a new, FDA approved, non-standard of care technology (OCT-Angiography~     by Optovue) to image and evaluate the treatment outcomes of using standard of care~     Intravitreal Aflibercept Injections for their approved use in patients diagnosed with~     neovascular AMD who are naive to previous Anti-VEGF therapies.~   "
41595|NCT03022279|"~     The objective of this study is to compare transversus abdominis plane (TAP) blocks to local~     wound infiltration (LWI) in terms of postoperative pain control in pediatric patients~     undergoing elective laparoscopic cholecystectomy. Our hypothesis is that TAP blocks will be~     superior to LWI for postoperative pain control resulting in decreased use of opioid /~     narcotic pain medication and decreased pain scored in the immediate 24-hour postoperative~     period. The rationale is that determining the effect of analgesia in this pediatric~     population is important to optimize clinical care.~   "
41596|NCT03022266|"~     The proposed study is a pilot randomized clinical trial (RCT). Participants in the~     intervention arm will participate in a 90-day adherence promotion program based on the theory~     of behavioral economics and administered through the Wellth mobile phone application.~     Subjects will be provided a CleverCap® Lite BLE C035 smart pill bottle (electronic monitoring~     (EM), device) containing a 90-day supply of aspirin (90 pills) and those in the intervention~     arm will be offered $150 for app-based medication check-ins, which consist of uploading daily~     photos of pills at the time of administration through the Wellth app. Subjects will have $2~     deducted from total rewards for each day that a medication check-in is missed. Subjects in~     the control arm will receive usual care and be monitored with the same EM device types used~     in the intervention arm.~   "
41597|NCT03022253|"~     Patent ductus arteriosus (PDA) is a common problem in preterm babies. Recently there have~     been various studies for and against an association between thrombocytopenia and PDA. A~     meta-analysis published in 2015 showed a marginally significant positive association between~     PDA and thrombocytopenia but these were all observational studies and there are no randomized~     controlled trials (RCT) on it. The investigators decided to conduct an RCT to determine~     whether liberal platelet transfusion criteria achieve earlier PDA closure rates than standard~     restrictive platelet transfusion criteria among thrombocytopenic preterm neonates (<35 weeks'~     gestation) with hemodynamically significant PDA presenting within the first 14 days of life.~     The investigators primary objective is to determine whether liberal platelet transfusion~     criteria achieve earlier PDA closure rates within 120 hours compared to standard restrictive~     platelet transfusion criteria among thrombocytopenic preterm neonates (<35 weeks' gestation)~     with hemodynamically significant PDA presenting within the first 14 days of life.~      The investigators will stratify the study population based on platelet count, i.e < 50000 and~     50000-100000 per microlitre, and will randomly allocate participants to control and~     intervention group. Babies in the intervention group will receive platelet transfusion to~     maintain the platelet count above 100,000 per microlitre. Babies in control group will~     receive platelets only when clinically indicated and as per current standard indications. The~     investigators will perform an echocardiogram at baseline to document a hemodynamically~     significant PDA (hsPDA) and then serially to look for the closure of PDA. Medical management~     of PDA will be as per unit policy. The investigators will follow the baby till PDA closes or~     120 hours post randomization.~   "
41609|NCT03022097|"~     This is a multiple dose, randomised, parallel, double blind, double dummy, multicentre and~     multinational Phase III study to determine the efficacy and safety of Aclidinium~     bromide/Formoterol fumarate compared with individual components and placebo and Aclidinium~     bromide compared with Placebo when administered to patients with stable Chronic Obstructive~     Pulmonary Disease (COPD).~   "
41610|NCT03022084|"~     The purpose of this study is to determine if a novel sound-based therapy in comparison to~     standard of care (cognitive behavioral therapy) results in reducing tinnitus-related effects~     for people with bothersome tinnitus.~   "
41598|NCT03022240|"~     The demand for magnetic resonance imaging (MRI) in pediatric patients is increasing due to~     its use in medical diagnosis and surveillance. Pediatric patients often require general~     anesthesia (GA) for MRI due to the need for prolonged immobility during the scanning process~     to obtain high quality images. Two widely used anesthetic techniques for pediatric MRIs are~     volatile-based anesthesia using sevoflurane and total intravenous anesthesia (TIVA) using~     propofol. Concerns have been raised regarding the potential neurotoxic effects of anesthetics~     on the developing brain. Within the animal literature, there is emerging evidence to suggest~     that both sevoflurane and propofol may cause inflammation, impacting brain cell survival and~     connections, thereby contributing to possible cognitive dysfunction. However, given the~     challenges in extrapolating the animal data to humans, and the relatively limited human~     cohort studies examining the long-term effects of anesthesia exposure, there is inadequate~     information available to make informed clinical decisions regarding the choice of optimal~     anesthetic agents for MRI in children. Therefore, this study will uniquely examine the~     mechanisms of two widely used anesthetics and their short and long-term impact on~     developmental outcomes in healthy children.~   "
41599|NCT03022227|"~     Cochlear implants (CIs) are medical devices now widely used in persons with severe to~     profound hearing loss. After a six month to one-year period following implantation, adults~     typically reach optimal fitting parameters, which lead to a stabilized hearing performance~     with their CI. At this stage, they usually enter a routine clinical after-care program, which~     involves regular appointmentsattheir CI center. Such visits aim at identifying any~     complication, which can be medical (abnormal cutaneous healing evolution) and/or device~     related, as well as any declinein performance (possibly related to the former). In France,~     the HAS (French Health Authority) recommends CI users tobe seen around threetimes a year~     during the second and third years after implantation, and then annually. While the schedule~     of appointments remains dependent on centers' practices, there is some kind of consensus~     about the minimal content of a long-term follow-up session:medical consultation, CI external~     parts checking, free field aided tonal audiometry, fitting adjustments if necessary,speech~     understanding assessments.~      Our center (CRIC) is one of the biggest French CI implant centers approved by the HAS,~     providing after-care for no less than 750 CI users, most of whomhave entered their long-term~     follow-up period. For some, attending follow-up appointments may need several hours, require~     taking a half-day off work, and entail travel expenses. Some patients may also have~     associated disabilities making it difficultto reach the center.Moreover, although the cohort~     of patients has increased over the years, the number of trained professionals and the~     clinical care infrastructures have not evolved proportionally. As a consequence, there is a~     need to reduce the number of routine visits, to allow more scope for complex cases andto~     efficiently identify issues.~      Remote consultation seems to address all the points listed above. However, it appears that~     little has been doneto develop remote after-care for cochlear implant recipients. Published~     studies mainly focus on the fitting aspects.~      The development of telemedicine has become one of the key priorities of the French government~     over the past few years, and it is now feasible thanks to the development of high speed~     connections (ADSL, mobile internet, high definition transmissions). Promoting telemedicine~     has several goals, the main one being to extend health care services to underserved patients~     in remote locations; it also allows some medical units to be freed upand to reserve~     infrastructures and professionals for patients requesting critical care. Of course,~     telemedicine is also meant to save costs.~      The objectif of this protocole is to evaluate the feasibility of telemedicine applied to~     adult cochlear implant users' follow-up by comparing the data of the medical consultation and~     speech therapy assessment, carried out in the CRIC service and videoconferencing when the~     patient is home, using his computer equipment to communicate with the CRIC.~   "
41600|NCT03022214|"~     Since 1948, health has been defined as a state of complete physical, mental and social~     well-being, and not merely the absence of disease and infirmity . However, a growing school~     of thought suggests that health represents an ability to be adaptable and flexible in~     response to daily stressors. It has been proposed that instead, the view of health should be~     towards the ability to adapt and self-manage in the face of social, physical and emotional~     challenges, which has been termed resilience.~      The theory of resilience relates health to the body's capacity to manage daily stressors~     (such as physical activity or oxidative fluctuations) that challenge homeostasis, with the~     return to homeostasis resulting from several physiological stress responses. Although this is~     an all-encompassing model, and the effects of pathogens and other stress factors are also~     relevant, this study will centre on the physiological aspects on this theory, focussing on~     the disruption through exercise.~   "
41601|NCT03022201|"~     This study will evaluate the therapeutic efficacy and safety of DA-9701 with domperidone in~     patients with Parkinson's disease~   "
41602|NCT03022188|"~     Neuroendocrine tumors (NETs) and carcinomas account for 10-15 % of all pancreatic~     incidentalomas. The management of pancreatic NETs depends on tumor stage and on presence or~     not of hormonal syndrome. The therapeutic approach for hormonally functional tumor, or large~     tumor (> 2 cm) with local, vascular or lymph nodes invasion, highly suggestive of malignancy,~     or in presence of metastasis, is well admitted: surgery is indicated or should be discussed.~     However, the attitude is less consensual for small (≤ 2 cm) non-functioning (NF) and~     non-metastatic lesions. In English, American or French recommendations, systematic surgical~     resection with lymphadenectomy is currently recommended in all medically fit patients. The~     follow-up (FU) is possible for tumors <2 cm (T1) located in the pancreatic head and for which~     enucleation is not feasible. Several recently published retrospective studies discuss the~     non- surgical management of the small NF incidentally detected pancreatic NETs (IPNETs) and~     highlight the necessity of developing guidelines for management of these patients. A strict~     correlation between tumor size and malignancy of these tumors was demonstrated in the~     single-center retrospective Italian study of Bettini and col., which included all patients~     with NF PNETs who underwent curative (R0) resection during 18 years. In the group of 51~     patients with small size of T (2 cm or less), incidentally discovered, the majority of lesion~     was benign, and the authors concluded that follow-up can be proposed in patients with~     incidentally discovered NF PNETs ≤ 2 cm. However in despite of small size and asymptomatic~     character of the tumor, the rate of malignancy of NF IPNETs ≤ 2 cm was estimated to be 24 %~     (in 18% and 6% of cases, uncertain behaviour and carcinoma were present). Given the inherent~     morbidities associated with pancreatic surgery, a risk-benefit calculation may favour~     surveillance rather than surgery in highly selected patients. Thus, a better understanding of~     NF IPNETs and identification of their prognostic factors can be of help to select a subgroup~     of patients who could benefit from a long-term surveillance rather than a systematic surgical~     resection. Clearly, large prospective trials are needed to validate this approach.~   "
41603|NCT03022175|"~     The purpose of this study is to assess the safety and tolerability of single and multiple~     intravenous doses of SPR741 when administered to healthy adult volunteers.~   "
41604|NCT03022162|"~     Since its introduction in the 1970s, Paclitaxel has been used as an effective anticancer~     agent against lung, breast, ovarian, leukopenia and liver cancer. But, Paclitaxel-induced~     peripheral neuropathy is the major dose-limiting side effect of paclitaxel.Paclitaxel induced~     peripheral neuropathy most commonly presents as~        1. Pain~        2. Burning,~        3. Tingling (pins and needles feeling) or electric/shock-like pain,~        4. Hyperalgesia,~        5. Allodynia,~        6. Increased sensitivity to cold or heat These symptoms are classically seen symmetrically~          in the distal extremities (glove and stocking distribution).~      Most adverse effects associated with chemotherapy are ameliorated after cessation of the~     therapy, but CIPN may persist in the longterm, with 30 % patients having CIPN related~     symptoms beyond 6 months after completion of chemotherapy7.Understanding the epidemiology of~     neuropathic pain in breast cancer patients has high clinical and public health significance.~   "
41605|NCT03022149|"~     The purpose of this study is to determine whether the remote ischemic preconditioning are~     effective in the treatment of mild to moderate vascular dementia.~   "
41606|NCT03022136|"~     Significant differences exist among various dermatome maps. In addition, there were no~     anatomical landmarks to evaluate the dermatome at the back. The investigators aim to map the~     sensory innervations of lower thoracic nerves and find the dorsal landmarks to evaluate~     sensory innervations by epidural block. Patients undergoing urological surgery will receive~     epidural block. Fifty patients with superior border of complete sensory loss to ice from T9~     to T12 (anterior median line) will be included in this study. The sensory loss to ice will be~     evaluated at midclavicular line, anterior axillary line, posterior axillary line, scapular~     line and posterior median line. The level of vertebrae will be identified and marked by~     ultrasound. The superior border of complete sensory loss to ice from anterior median line to~     posterior median line will be recorded for every patient. The dermatome map of T9 to T12 will~     be drawn. The landmarks of sensory innervations at posterior median line will be established~     using vertebrae.~   "
41607|NCT03022123|"~     270 untreated patients, age between 18 and 65 years , with diffuse large B-cell lymphoma~     (B-DLCL) were treated with a pegylated liposomal doxorubicin (PL-doxorubicin) modiﬁed~     CHOP-rituximab regimen. PL-doxorubicin 35-40 mg/m(2)and epirubicin 70mg/m(2) were given in~     combination with standard dosage of prednisone, vincristine, cyclophosphamide, rituximab~     (according to CHOP-R regimen) every 21 days for six courses.~   "
41608|NCT03022110|"~     The purpose of this study is to compare the effect of lumen-apposing metal stent (LAMS) and~     traditional plastic stent on the drainage of pancreatic pseudocyst, mainly to observe the~     cyst recurrence rate of 12 months after treatment.~   "
41611|NCT03022071|"~     Background: Major depressive disorder (MDD) is a prevalent psychiatric condition associated~     with significant disability, mortality and economic burden. MDD is ranked fourth in terms of~     disease burden as defined by the World Health Organization (2001). Cognitive Behavioral~     Therapy (CBT) and Psychodynamic Psychotherapy (PDT) are found to be equally effective for~     patients with depression. However, many patients do not respond sufficiently to treatment and~     relapse rates are high. To be able to offer individualized treatment, a clinically important~     question is therefore whether some patients profit more from one of the two therapies. At~     present little is known on which patient characteristics (moderators) may be associated with~     differential outcomes of CBT and PDT and through what kind of therapeutic processes and~     mechanisms (mediators) improvements occur in each therapy mode. There are actually only~     theoretical assumptions sparsely supported by research findings on what moderates and~     mediates the treatment effects of CBT and PDT.~      Aims: The overall aim of this project is to examine putative moderators and mediators in CBT~     and PDT and develop more basic knowledge about their impact on outcomes of psychotherapy for~     patients with MDD.~      Methods and study design: The study is a randomized clinical trial. One hundred patients will~     be randomized to one of two treatment conditions. The patients will be treated over 28 weeks~     with either CBT (one weekly session over 16 weeks and 3 booster sessions (monthly) during the~     rest of the 28 week study period) or PDT (one weekly session in 28 weeks). The patients will~     be evaluated at baseline, during therapy, at the end of therapy, and at follow-up~     investigations 1 and 3 years after treatment termination. The outcome measures comprise a~     large range of clinical and process variables, including assessment tools measuring specific~     preselected putative moderators and mediators.~      Discussion: The clinical outcome of this trial may guide clinicians to decide what kind of~     treatment should be offered the individual patient. Moreover, it will shed light on what kind~     of mechanisms in psychotherapy that is followed by symptom improvement and increased~     psychosocial functioning.~   "
41612|NCT03022058|"~     The EarEEG system is a novel non-invasive, unobstructed and discrete method for recording EEG~     in which the signal is recorded using dry-contact electrodes embedded on a customised ear~     piece. One intended medical indication of the EarEEG system is the detection of~     hypoglycaemia-induced changes in the EEG in patients with type 1 diabetes. Currently, no~     studies exist investigating the detection of hypoglycaemic episodes by use of ear electrodes.~     While a finger prick test accurately measures the blood glucose level, it does not provide~     continuous measurements, and hence it is unreliable as a hypoglycaemia alarm. Recent studies~     have indicated that the use of continuous glucose monitoring (CGM) reduces the risk of severe~     hypoglycaemia. However, some find these devices troublesome to use and utilisation of CGM has~     remained limited to date. Observational data show that only a small percentage of patients~     with type 1 diabetes are using CGM on an ongoing basis. Thus, there is a medical need for a~     reliable hypoglycaemia detection device which is easy and convenient to use.~      This clinical study aims at investigating the feasibility of measuring hypoglycaemia induced~     changes in the EEG by use of the EarEEG system.~   "
41613|NCT03022045|"~     The purpose of this study is to investigate the safety and efficacy of two different dose~     regimens of risankizumab for Japanese subjects with generalized pustular psoriasis (GPP) or~     erythrodermic psoriasis (EP).~   "
41614|NCT03022032|"~     This research study is evaluating a new smartphone application named the Helping Our~     Patients Excel (HOPE) app with Fitbit devices. The HOPE app was designed to learn about~     improving quality of life~   "
41615|NCT03022019|"~     Rationale:~      Autologous epidermal cell suspension grafting is an effective method of surgical treatment in~     vitiligo, which is suitable for treating large areas with good cosmetic results. The~     RenovaCell Autologous Cell Harvesting Device (Avita Medical Europe Limited, Cambridge, UK)~     (previous name: ReCell) is a device which, compared to other forms of autologous epidermal~     cell suspension grafting, is easier in use showing similar results. Efficacy and safety of~     the ReCell device was proven in segmental vitiligo and piebaldism. However, the efficacy in~     non-segmental vitiligo is not yet confirmed in randomized controlled trials. The~     investigators hypothesize that grafting using the ReNovaCell device in combination with~     standard of care is also effective in stable non-segmental vitiligo and more effective than~     standard of care alone.~      Objective:~      Primary: to assess the efficacy and safety of ReNovaCell grafting combined with 311 nm UVB~     therapy and topical anti-inflammatory therapy for the treatment of stable non-segmental~     vitiligo. Secondary: to assess, satisfaction, cosmetic acceptability, noticeability and~     persistence of repigmentation after ReNovaCell transplantation.~      Study design: Prospective, observer-blinded, randomised, within subject, controlled, study.~      Study population: 20 patients ≥ 18 years with stable non-segmental vitiligo receiving~     standard of care (311 nm UVB therapy and topical anti-inflammatory therapy) for at least 6~     months at the Netherlands Institute for Pigment Disorders (NIPD) at the Academic Medical~     Centre, University of Amsterdam.~      Intervention: In patients already receiving standard of care (311 nm UVB therapy + topical~     anti-inflammatory therapy) 2 comparable depigmented regions are randomised to receive~     ReNovaCell grafting or no grafting. Standard of care will be given according to the standard~     treatment protocol of our institute.~      Main study parameters/endpoints:~      Primary outcome:~      Objective assessment of the degree of repigmentation three and six months after ReNovaCell~     grafting with a digital image analysis system. To assess the pigmentation, the contours of~     pigmentation are copied on a transparent sheet before, three and six months after treatment,~     after which the sheets are scanned and digital image analysis is used to compute the affected~     surface. By comparing pre- and post-treatment pictures, the relative surface showing~     repigmentation expressed as percentage of the selected treated patch is computed.~      Secondary outcomes:~        -  Patient Reported Outcomes: satisfaction, cosmetic acceptability, noticeability~        -  General patient assessed outcome per treatment region on a scale from 0-3 (poor,~          moderate, good or excellent).~        -  Visual assessment of percentage repigmentation by blinded observer and color match to~          normal skin~        -  Visual assessment of side effects per treatment region (hyperpigmentation,~          hypopigmentation and scarring on a scale from 0-3) by a blinded investigator.~        -  A small amount of the suspension of the included patients and the redundant lesional~          punchgrafts of all patients will be used for flow cytometric analyses of the cellular~          composition of the grafted cell suspension, and expression analysis of melanin~          synthesis-related genes. These data will be correlated to the clinical data.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: As the study involves large depigmented lesions, which are too large to treat in~     regular surgical treatment (punch grafting), patients will not miss any regular treatment.~     The time investment for the patient will be approximately 20 minutes for the punchgrafting~     session, 75 minutes for the cell suspension grafting session and 15 minutes for the three~     follow-up visits. Two of the five visits are part of the standard of care UVB follow-up~     regimen and are therefore not additional due to the study. Infection in the grafted area or~     the donor site may occur but is very rare; the risk of mild textural changes in the donor~     site is moderate. Hyperpigmentation of the treated area does occur often, although this~     improves over time in most cases. In case of improvement of the depigmentation, patients may~     receive another treatment for the (contralateral) untreated side.~   "
41616|NCT03022006|"~     The number of hemodialysis patients with chronic renal failure in Japan exceeds 0.3 million~     and is showing an increasing trend. The rate of infection with hepatitis C virus (HCV) is~     high in hemodialysis patients, and it has been revealed that the prognosis is poorer in~     HCV-infected hemodialysis patients compared to uninfected patients; therefore, aggressive~     therapeutic intervention is required.Investigator previously reported the efficacy and safety~     of a NS5A inhibitor; daclatasvir and a HCV protease inhibitor; asunaprevir combination~     therapy for Japanese dialysis patients with genotype 1 HCV infection. However, the duration~     of the treatment is 24 week, which is quite longer than current standard 12 week therapy .~      elbasvir/grazoprevir combination therapy is oral anti-HCV 12 week therapy without the use of~     IFN/ribavirin, and a good therapeutic effect has been reported in Japanese phase II studies .~     Of note is that these drugs are metabolized mainly in the liver and thus they can be used in~     patients with chronic renal failure. Recently, David Roth et al reported that the efficacy~     and safety of elbasvir/grazoprevir combination therapy for patients with hepatitis C virus~     genotype 1 infection and stage 4-5 chronic kidney disease. In this report, they revealed that~     elbasvir/grazoprevir combination therapy could achieve SVR rate of 99% in the modified full~     analysis set.~      However, no adequate clinical investigation has been performed in Japan, thus far concerning~     the therapeutic effect and safety of elbasvir/grazoprevir combination therapy in Japanese~     hemodialysis patients.~   "
41617|NCT03021993|"~     The purpose of this study is to look at the effectiveness of nivolumab in patients with oral~     cavity cancer (OCC) who are about to undergo surgery.~   "
41618|NCT03021980|"~     This study will evaluate the effectiveness of SuperFIT, an integrative lifestyle intervention~     for preschool children. It will consist of both an preschool component and a family component~     and is aimed at increasing healthy nutrition and physical activity. Half of the participating~     preschools will implement SuperFIT, while the other half of the preschools will continue as~     usual.~   "
41619|NCT03021967|"~     Hospitals, doctors and caregivers, who take care of increasingly heavy patients, are faced~     with ever more complex situations, particularly in the case of severe, progressive, and~     incurable pathologies.~      Thanks to their willingness and expertise, these care providers try to guarantee the~     continuity and quality of care for both patients and patients in a palliative situation.~     Nevertheless, these same actors testify to the complexity they encounter in the care of~     patients in advanced or terminal stages, especially since the concept of palliative care,~     which was often erroneously reduced during the Any end of life and therefore death, remains a~     source of questions, contradictions, even resistances.~      In this context, how do physicians and caregivers appropriate palliative care? How do they~     react to the complexity and intensity of certain situations? Do they have specific~     expectations of help or support in the face of certain difficulties? Are there actions to be~     carried out and developed to make the aid given to these actors of the palliative approach~     more efficient?~      These are the topics that the HUS palliative care service proposes to explore through a study~     of physicians and caregivers working in HUS services for adult patients with LISP.~   "
41620|NCT03021954|"~     This study aims to see if platelet rich plasma (PRP) have beneficial effect on the repair of~     pelvic floor muscle damage in primipara. Therefore, this double blinded randomized clinical~     trial compares the pelvic floor muscle repair in primipara following labor between the~     interventional group who received intramuscular PRP injection in levator ani muscle and the~     control group, as assessed by ultrasonography, perineometry, and biomarker assessments.~   "
41621|NCT03021941|"~     In August of 2014, the FDA approved ELELYSO for long-term enzyme replacement therapy (ERT)~     for pediatric subjects with a confirmed diagnosis of Type 1 Gaucher disease. The recommended~     dosage for treatment-naïve adult and pediatric subjects 4 years of age and older is 60 units~     per kg of body weight administered every other week as a 60 to 120 minute intravenous~     infusion. As a postmarketing commitment, the Sponsor agreed to evaluate the pharmacokinetics~     (PK), pharmacodynamics (PD), and safety of Elelyso (taliglucerase alfa) in pediatric subjects~     with Type 1 Gaucher Disease. in at least 5 subjects with body weight less than 15 kg; at~     least 5 subjects with body weight 15 to less than 20 kg; and at least 5 subjects with body~     weight of 20-25 kg with Type 1 Gaucher disease dosed at 60 units/kg every other week.~      When applicable, PD measurements for children enrolled in the PK study may be obtained~     through the taliglucerase alfa registry (PMR 1895-5) and will include organ volumes (spleen~     and liver), hematological values (hemoglobin and platelets) as well as growth (height and~     weight) data. Safety data, including any serious hypersensitivity reactions, such as~     anaphylaxis, as well as changes in antibody status (ie, detection and titers of binding and~     neutralizing antibodies, and detection of IgE antibodies), will also be collected through the~     taliglucerase alfa registry.~   "
41622|NCT03021928|"~     Title:~      Optimal Delay Time to Initiate Anticoagulation after Ischemic Stroke in Atrial Fibrillation~     (START): a pragmatic, adaptive randomized clinical trial.~      Primary Objective:~      • To determine the optimal time to initiate anticoagulation with a Non-Vitamin K Oral~     Anticoagulant (NOAC) after ischemic stroke in patients with non-valvular atrial fibrillation.~      Secondary Objectives:~        -  To compare the rates of primary adverse outcomes in a per protocol analysis~        -  To compare 30 day clinical outcomes by the modified Rankin scale among the~          time-to-treatment groups~        -  To compare 90 day clinical outcomes by the modified Rankin scale among the~          time-to-treatment groups~        -  To explore the optimal timing in subgroups of age, sex, outcome category, and NOAC~          choice~   "
41623|NCT03021915|"~     This is a single center, prospective, controlled pilot safety research study. The primary~     objective of this research study is to assess the safety with the use of the OvaPrime~     procedure in women who are diagnosed with either primary ovarian insufficiency (POI) or poor~     ovarian response (POR).~      A maximum of ninety-five (95) subjects will be enrolled consisting of a minimum of thirty~     (30) POI subjects and a minimum of fifty (50) POR to achieve the target sample size of 70~     Modified Intent-to-Treat (mITT) subjects as the primary analysis population. Each subject~     shall have one ovary exposed to the EggPC cells while the contralateral ovary is exposed to~     the EggPC vehicle as a means to have each subject serve as their own control. Results between~     the treatment and control ovary will be examined for relevant endpoints such as antral~     follicle counts.~      The duration of the research study is estimated at approximately 6 years total, for the~     period spanning enrollment (estimated at approximately six months), eight months to the last~     hyperstimulation and through completion of 5-year follow-up (main study protocol with one~     year primary endpoint and LTFU sub-study which extends to 5 additional years).~   "
41624|NCT03021902|"~     This study proposes a novel early intervention combining Intravenous (IV) amino acids plus~     in-bed cycle ergometry exercise to improve physical outcomes in critically ill patients. The~     investigators hypothesize that this innovative approach will improve short-term physical~     functioning outcomes (primary outcome), as well as amino acid metabolism, body composition,~     and patient-reported outcomes at 6-month follow-up.~   "
41625|NCT03021889|"~     Introduction: Prolonged use of antiretroviral therapy is associated with metabolic and bodily~     changes such as lipodystrophy, diabetes mellitus, insulin resistance and dyslipidemia latter~     being associated with a higher chance of cardiovascular events and death.~      Objective: To evaluate the effect of nutritional therapy in dyslipidemic adolescents living~     with HIV / AIDS in antiretroviral therapy.~      Method: This is a randomized clinical trial with young people 13-19 years in outpatient~     treatment in a general hospital to present dyslipidemia. The intervention group received~     nutritional counseling for 12 weeks and weekly flights to nutritional counseling. The control~     group received standard care consisting of medical care. Demographic, clinical, nutritional~     variables, food surveys and lipid profiles were collected at baseline and at the end of the~     study for both groups.~   "
41626|NCT03021876|"~     L-carnitine is synthesized from lysine and methionine. Postmortem concentrations of carnitine~     in liver, muscle, heart, kidney, and brain averaged only one-fourth to one-third those in~     corresponding tissues of eight normally nourished non-hepatic patients who died after an~     acute illness of a 1-3-day duration. In the recent years, it has been reported that sirtuin 3~     (SIRT3) is protective against acute kidney injury (AKI) and suggest that enhancing SIRT3 to~     improve mitochondrial dynamics has potential as a strategy for improving outcomes of renal~     injury. In the current study, it is the first clinical interventional research whether~     L-carnitine corrects ammonia metabolism associated with liver injury in hepatectomized~     patients.~   "
41627|NCT03021863|"~     Questionnaires are frequently used in online research, however recruiting, and completion~     rates of online participants from a variety of cultures and demographic backgrounds can be~     challenging. The challenge is greater in an online cohort because there is no way to observe~     the participant beyond what is contributed online. Poor recruiting and completion can result~     in underpowered research that may not be representative of the sample population. This can~     trigger an increase in costs as the recruitment period may have to be extended until sample~     size is reached. When recruiting and completion rates are inadequate studies may have to be~     terminated and the answer to the research question can remain unknown.~      To mitigate these challenges, reminder emails are sent to questionnaire respondents. There is~     uncertainty about how the tone of the email reminder affects the proportion of recruitment~     rates.~      A nested randomized trial will be used to test the intervention of tone delivery in survey~     email reminders to establish an evidence base. This study (ResponseQT) proposes to link with~     the anticipated 20,000 person international cohort study, (How Frequently and in What Format~     are Research Trial Results Disseminated to Participants: A Survey of Trialists (ResponseQT)~     to explore the evidence of effect for the research question, Does the tone of a survey email~     reminder affect the proportion of survey participants recruited. The population will consist~     of researchers who have published a clinical trial indexed in Pub Med in 2014-15.The~     intervention is the tone of questionnaire email reminders and the outcomes will be the~     proportion of participants recruited after invitation (partial plus complete responses)~     following reminder 1 and 2.~   "
41629|NCT03021837|"~     This study will look at blood sugar levels in pregnant women who have been given a~     glucocorticoid (steroid) medication to enhance fetal lung maturity. The findings will help~     determine the likelihood, predictive value, adverse effects, response of patients diagnosed~     with gestational diabetes and time course of blood sugar elevation following steroids.~   "
41630|NCT03021824|"~     An assessment of early management of moderate-severe ARDS in the United States, including~     ventilator management and use of rescue therapy.~   "
41631|NCT03021811|"~     Multi-center, prospective, interventional, uncontrolled open-label study evaluating the~     real-life use of KLOX LumiHeal BioPhotonic System in chronic wounds management (venous leg~     ulcers, diabetic foot ulcers, pressure ulcers).~   "
41632|NCT03021798|"~     The SARA-OBS is a single arm phase 2 clinical trial, with no investigational product and no~     therapeutic intervention that will be conducted in three European countries, (Belgium, France~     and Italy), and in the US.~      300 community dwelling older adults (men or women≥65 years) reporting loss of physical~     function and at risk of mobility disability, will undergo mobility functional evaluation and~     Dual-energy X-ray Absorptiometry DXA scan for body composition determination twice, at~     six-month interval.~      Participants aged ≥ 65 years complaining of poor physical function will be selected to~     perform SPPB (Short Physical Performance Battery)tests. Those with SPPB scores ≤ 8/12 will be~     selected to perform body composition analysis with DXA Scan. Participants with ALM/BMI <~     0.789 in men and 0.512 in women will be included. The investigational phase will comprise two~     main visits: the inclusion visit and the 6-month visit. Both the 6-minute walk distance test~     and the 400-metre walking test will be administered at the main visits. Patient Reported~     Outcomes (PROs) will be completed by the patients at the same visits.~   "
41633|NCT03021785|"~     This is a multicenter, open-label study to evaluate the safety, pharmacokinetics,~     immunogenicity, and preliminary efficacy of multiple intravitreal injection TK001 in patients~     with AMD. It consists of core study (12 weeks) and extension study (40 weeks).~   "
41634|NCT03021772|"~     Intravenous regional anesthesia (IVRA) is described firstly in 1908 by August Bier. It is~     simple, safe, reliable, less cost, efficient method in forearm surgery. The advantage of this~     method has fast return of motor and sensory function which enables patients for earlier~     discharge. However, this method has disadvantages such as tourniquet pain, insufficient~     muscle relaxation and postoperative analgesia.~      Lidocaine inhibits action potential propagation within neuronal tissue by binding to~     receptors in Na+ channels located on the nerve cell membrane. Lidocaine IVRA is safe and~     effective and is associated with a rapid onset (4.5 minutes) of anesthesia after injection~     and termination of analgesia (5.8 ± 0.5 minutes) once the tourniquet is deflated.~      Neostigmine is a typical cholinesterase inhibitor. It increases the level of acetylcholine~     (Ach) and indirectly stimulates both nicotinic and muscarinic receptors. In anesthesia,~     neostigmine is a drug that has been used for reversal of residual neuromuscular block.~     Administration of neostigmine by intrathecal and epidural routes has been found to cause~     analgesia by inhibition of the breakdown of Ach in the spinal cord.~      Dexamethasone is commonly used in anesthesia to prevent postoperative nausea and vomiting~     (PONV). Two recent meta-analyses have documented that dexamethasone also reduced~     postoperative pain and opioid requirement. Intravenous dexamethasone has also been shown to~     improve postoperative pain control in patients receiving spinal or epidural morphine.~      Hong et al reported that intravenous dexamethasone in combination with a caudal block with~     ropivacaine prolonged the duration of postoperative analgesia without adverse effects in~     children undergoing orchidopexy. So the investigators expect that addition of dexamethasone~     or neostigmine will affect duration and postoperative analgesia in bier block.~   "
41635|NCT03021759|"~     In this study, the investigators will conduct a pragmatic, cluster-randomized, controlled~     trial to evaluate an active choice intervention with and without social comparison feedback~     to increase physician statin prescribing rates for eligible patients.~   "
41636|NCT03021746|"~     To understand the effectiveness of three approaches to address diabetes self-management~     support compared to enhanced usual care in church-based settings.~   "
41637|NCT03021733|"~     This project will involve planning and implementing a two-arm prospective pragmatic cohort~     clinical trial in patients with known rotator cuff tears.~   "
41638|NCT03021720|"~     Randomized trial comparing uterine fibroid embolization patient satisfaction and quality of~     life with femoral versus radial arterial access~   "
41639|NCT03021694|"~     The importance of protein in nutrition is momentous to ones health. Dietary proteins are~     essentially nutritional because they contain amino acids, which the body uses to build its~     own proteins, as well as other molecules that are essential for life. Protein when consumed,~     travels through your digestive system and is absorbed. They then enter the blood for~     transport to bodily tissues, and therefore, can be detected by blood sampling. There are~     differing amounts of each amino acid found in different types of protein supplements. Certain~     amino acids (the essential amino acids) are helping in stimulating muscle growth and helping~     to maintain muscle mass and function. It is important to understand how quickly these amino~     acids can be detected in your blood as well as how they affect blood glucose (blood sugar)~     and insulin activity. Understanding the effects of protein type on changes in levels of blood~     amino acids, glucose and insulin will provide helpful insight for the suggestion of~     supplement use.~   "
41640|NCT03021681|"~     Chronic obstructive pulmonary disease(COPD)is characterized by recurrent cough, expectoration~     and asthma, and eventually develop chronic pulmonary heart disease ,chronic respiratory~     failure and even death. The current clinical treatments for these patients are symptomatic~     treatment cannot solve the problem of the damaged lung structure fundamentally. Recent~     studies show that bronchial basement the layer of cells is a kind of cells in the bronchial~     epithelial basal layer position, the specific expression of Krt5 antigen with the~     regeneration and repair of lung function , these cells have the activity similar to adult~     tissue stem cells. Its division and migration are more active and can continue to produce new~     cells to complement the death of other types of epithelial cells with functional plasticity~     which can be used to direct repair the bronchial and alveolar structures. It has been proved~     that bronchial basal cell transplantation can repair the damaged lungs of experimental~     animals . The bronchial basal cells from autologous tissue, so there is no immune rejection~     problem. Also because the bronchial basal cells derived from adult tissues which is a part of~     the body, so there is no risk of a tumor (in animal experiments, In animal experiments,~     bronchial basal cells transtracheal input 100 times in human dose still no tumor formation).~     In the early stage, patients with COPD (2 cases), bronchiectasis (2 cases) and interstitial~     lung disease (1 case) received the treatment, and the overall effect was good. Diseases were~     alleviated and recovered to some different extend.The study was to brush bronchial basal~     cells through fiberbronchoscopy in COPD patients and cultured in vitro, and then through the~     bronchoscope transfusion to the lesion site. To preliminary evaluate the efficacy and safety~     of autologous bronchial basal cells in the treatment of chronic obstructive pulmonary~     disease.~   "
41667|NCT03021330|"~     In this open-label, randomized, prospective clinical trial, newly-diagnosed AML patients will~     be randomized into 2 groups. In the experimental arm, patients receive DA induction regimen~     with intermediate dose of cytarabine. In the control arm, patients receive DA regimen with~     standard dose of cytarabine.The efficacy of induction therapy containing intermediate dose of~     cytarabine is evaluated and adverse events associated with treatment are recorded.The primary~     end point is overall survival.~   "
41641|NCT03021668|"~     Although outcomes of pancreaticoduodenectomy have improved, it remains a procedure with a~     high perioperative complication rate. Surgical site infection is one of the most common~     complications after pancreaticoduodenectomy. In a retrospective review of all patients who~     underwent pancreaticoduodenectomy at Johns Hopkins between 9/2011 and 8/2014, a total of 679~     patients, 30-day surgical site infection was observed in 16.7%. By univariate analysis,~     perioperative blood transfusion, operative time greater than 7 hours, preoperative~     chemotherapy and/or radiation, bile stent, absence of a superficial wound vacuum closure~     device, and vascular resection were associated with surgical site infection (all, p<0.05). On~     multivariable analysis, pre-operative bile stent/drain and neoadjuvant chemotherapy were~     independent predictors of surgical site infection (all, p<0.001). Studies in colorectal~     patients have found an estimated cost of up to $1400 per patient secondary to prolonged~     hospitalization, wound care, and wound complications in patients with procedures complicated~     by a surgical site infection. Furthermore, in another study of 1144 patients undergoing~     pancreaticoduodenectomy between 1995 and 2011 at Johns Hopkins Hospital, post-operative~     complications delayed time to adjuvant therapy, decreased median survival.~      The hypothesis of the investigator(s) is that placement of Prevena Peel & Place Dressing~     using the standard Acelity vacuum dressing after suture on patients undergoing~     pancreaticoduodenectomy at highest risk of infection will result in a significant decrease in~     surgical site infection rate. The investigator(s) plan to perform a randomized control trial~     where the patients who have had pre-operative bile stent/drain placement and/or neoadjuvant~     chemotherapy will undergo closure with Prevena Peel & Place Dressing using the standard~     Acelity vacuum dressing after suture versus standard closure. The investigator(s) will then~     follow the participant(s) for 30 days postoperatively to determine surgical site infection~     and other perioperative complication rate.~   "
41642|NCT03021655|"~     This study is a 3-arm randomized controlled trial including: (1) Adventure-based training~     intervention group, (2) WhatsApp intervention group and (3) Control group.~   "
41643|NCT03021642|"~     This is a Phase I, open label, randomized, crossover trial to investigate the relative~     bioavailability of tepotinib in healthy volunteers. Twenty-four volunteers will be randomized~     to one of the two treatment sequences: Sequence A: test, reference, Sequence B: reference,~     test. The reference treatment refers to the current Phase II film-coated tablet (5 * 100~     milligram (mg) tepotinib film-coated tablets) and the test treatment to the new Phase III~     film-coated tablet (1 * 500 mg film-coated tepotinib tablet).~   "
41644|NCT03021629|"~     Vitamin D deficiency is known to be significantly associated with high myopia. This study~     investigated the vitamin D status in patients with high myopia and primary open-angle~     glaucoma, in order to understand the relationship between high myopia and the development of~     primary open-angle glaucoma.110 primary open-angle glaucoma patients, 110 high myopia~     patients and 110 age-matched people in the Han population were enrolled. Serum levels of 1a,~     25-Dihydroxyvitamin D3 were measured by an enzyme-linked immuno-absorbent assay.Vitamin D~     receptor polymorphic analysis was studied by polymerase chain reaction-restriction fragment~     length polymorphism technique.~   "
41645|NCT03021616|"~     This study will determine the cardiovascular effects of energy drink consumption in healthy~     individuals through electrocardiogram (ECG), central blood pressure assessment, and ROTEM®~     analysis.~   "
41646|NCT03021603|"~     Aims. This paper describes the study protocol of a manualized brief positive intervention~     (BHI). In addition, it reports the on the modification of a hope intervention based on the~     theoretical proposition - hope theory, and its feasibility when applying to palliative cancer~     and non-cancer patients.~      Background. Hope was found to account for therapeutic changes in clients with depressive~     symptoms or chronic pain. Nevertheless, little is known about the integration of such active~     ingredients to brief and low intensity psycho-therapeutic interventions to patients receiving~     palliative care were not adequately tested.~      Design. The study included two stages: (1) manual development, and (2) a single blinded~     randomized controlled trial.~      Methods. Participants will be randomly assigned in equal number into either the brief hope~     intervention or the controlled arm on completion of the baseline assessment. Participants of~     the intervention group will be receiving the four-week intervention, while those allocated to~     the control arm will be receiving the routine care and social chats. The intervention is a~     manualized program that consists of four sessions at weekly intervals (two face to face~     sessions and two telephone follow up in between). The core content is modified from an eight~     sessions hope therapy. Expert panel feedback and trial on targeted populations were~     completed. Four participants received the program to determine its acceptability prior to~     feasibility testing. The process and practical considerations were evaluated to allow~     refinement of the program and to ensure the quality of intervention.~      Outcome measures comprise of changes in state hope score and the depression scores measured~     respectively by State Hope Scale and Centre for Epidemiological Study Depression Scale. The~     secondary outcomes are the common signs and symptoms in cancer patients measured by The~     Condensed Memorial Symptom Assessment Scale. Data collection will be done prior to the~     intervention (baseline), immediately and one month after the intervention. Additional use of~     qualitative interview to explore their experiences in the intervention, including~     satisfaction with the intervention and the treatment fidelity will be conducted.~   "
41647|NCT03021590|"~     Comparison Efficacy of 14-day Concomitant therapy between levofloxacin and Clarithromycin on~     the Eradication of Helicobacter Pylori in Syrian population~   "
41648|NCT03021577|"~     The investigators hypothesize that the orbital atherectomy system (OAS), a newer generation~     atherectomy device, reduces the incidence of microcirculatory compromise as compared to older~     generation rotational atherectomy (RA) due to differences in the mechanism of~     athero-ablation.~   "
41649|NCT03021564|"~     Unexpected cardiac arrest involves approximately 0.5 to 5% of patients admitted in Intensive~     Care Unit (ICU). Even if they have a technical environment conducive to prompt diagnosis and~     prompt treatment, patients hospitalized in ICU suffer from chronic illnesses and organ~     failure(s) that obscure the prognosis of cardiac arrest. Although extra cardiac arrhythmias~     or intra-hospital arrests are the subject of numerous publications, few studies specifically~     focus on unexpected cardiac arrest in ICU (none in France). The objective of our work is to~     produce a prospective epidemiological description of unexpected cardiac arrest in in French~     ICUs.~   "
41650|NCT03021551|"~     This is a prospective, observational, clinical study designed to evaluate the clinical~     utility of the Oxygen Reserve Index (ORI) as an early warning for arterial hemoglobin~     desaturation during the induction of general anesthesia and tracheal intubation in obese~     patients undergoing elective surgical procedures.~   "
41651|NCT03021538|"~     This study seeks to compare outcomes of 2 different methods of cardiopulmonary support during~     lung transplant surgeries.~   "
41652|NCT03021525|"~     To evaluate the impact of perioperative, algorithm driven, hemodynamic therapy based on~     individualized fluid and cardiac output optimization on postoperative moderate and severe~     complications in patients undergoing major abdominal surgery including visceral, urological,~     and gynecological operations.~      In the proposed study, hemodynamic therapy is tailored individually to each patient, based on~     individual preload optimization by the functional parameter pulse pressure variation (PPV)~     and based on an individually titrated goal of cardiac index. The proposed study therefore~     further develops the concept of hemodynamic goal-directed therapy to individually set goals~     and is designed to assess its impact on morbidity and mortality.~   "
41699|NCT03020914|"~     Patients will be randomly assigned to either one of two groups:~        1. Standard of care sedation~        2. Audiovisual distraction during surgery and in the recovery room using video goggles and~          headphones; patients can choose a movie from a preexisting library~      Monitoring and anesthesia regimen will be standardized~   "
41653|NCT03021512|"~     Patients who underwent bilateral bifocal or trifocal lenses implantation for presbyopia~     correction with monofocal intraocular lenses implantation are supposed to have sufficient~     uncorrected vision capacity for activities of daily living (ADLs) that require: a) distant~     vision (DV), (ie. driving), b) intermediate vision (IV), (ie. computer word processing), c)~     near vision (NV), (ie. book reading). Primary objective of the study is the comparison in a~     series of ADLs of two cohorts of patients (group 1: subjects with bilateral bifocal lenses~     implantation, group 2: subjects with bilateral trifocal lenses implantation)~   "
41654|NCT03021499|"~     The purpose of this study is to assess the efficacy of voclosporin compared with placebo in~     achieving renal response after 52 weeks of therapy in subjects with active lupus nephritis.~   "
41655|NCT03021486|"~     The goal of this clinical research study is to learn if chlorpromazine, high-dose~     haloperidol, or a combination of the 2 drugs can help to control the symptoms of delirium~     (loss of contact with reality) in patients with advanced cancer who did not respond to~     low-dose haloperidol. High-dose haloperidol doses are usually about 2-4 times the size of~     low-dose haloperidol.~      In addition, researchers want to learn if treating patients with these drugs can help to~     lessen any distress that their caregivers may be having.~      The safety of these drugs will also be studied.~      This is an investigational study. Both chlorpromazine and haloperidol are FDA approved and~     commercially available for the treatment of bipolar disorder and psychotic disorders. Their~     use to help control delirium is investigational. The study doctor can explain how the study~     drugs are designed to work.~      Up to 54 patients will take part in this study. All will be enrolled at MD Anderson.~   "
41656|NCT03021473|"~     This is a prospective, non-blinded, non-randomized, non-interventional study of the Oxygen~     Reserve Index (ORI) in a clinical setting. It is designed to evaluate the potential clinical~     utility of the ORI as an early warning of impending arterial oxygen desaturation and collect~     additional data characterizing the correlations with arterial blood oxygen content.~   "
41657|NCT03021460|"~     This phase II trial studies how well pembrolizumab and ibrutinib work in treating patients~     with stage III-IV melanoma that cannot be removed by surgery. Monoclonal antibodies, such as~     pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Ibrutinib~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~     Giving pembrolizumab and ibrutinib may work better in treating patients with melanoma.~   "
41658|NCT03021447|"~     Postoperative pain is a significant postoperative problem and it could be persistent if~     proper management is not provided. However, each patient shows different intensity of pain~     and different sensitivity to analgesics even if they underwent same procedures. Therefore, it~     would be useful to find the way to predict the postoperative pain sensitivity.~      Propofol, a popular anesthetic agent, induces pain during injection, which can not completely~     prevented by opioid or lidocaine in some patients. This is considered to be related to~     patient's pain sensitivity and it might be associated with postoperative pain sensitivity.~      Therefore, the relation of propofol injection pain and postoperative pain intensity will be~     explored.~   "
41659|NCT03021434|"~     The present study is a cluster randomized control trial of low-cost microbiological water~     test kits in rural and peri-urban communities in the Kanpur region of Uttar Pradesh, India.~   "
41660|NCT03021421|"~     Purpose: This prospective, randomised, controlled, single-blind, multicentre study was~     designed to investigate the effects of peripheral nerve block methods (applied using~     unilateral spinal anaesthesia [USA] on elderly patients scheduled to undergo total knee~     arthroplasty) on perioperative haemodynamic parameters and the postoperative analgesia~     period.~      Materials and Methods: Sixty patients in the American Society of Anesthesiologists (ASA)~     Physical Status II-III group were randomly divided into two groups. Spinal anaesthesia was~     performed in the USA group, in the lateral position through the intervertebral space, with 2~     ml of hyperbaric bupivacaine (L4-L5 or L3-L4); 0.5% bupivacaine hydrochloride and 2%~     lidocaine were combined for the psoas compartment-sciatic (PCS) group, and the mixture was~     used for psoas compartment block (PCB) and sciatic nerve block. The haemodynamic parameters~     were recorded every 5 minutes until the end of the preoperative and perioperative operation~     periods and postoperative first analgesic application time.~   "
41661|NCT03021408|"~     Evaluation of the effectiveness of three different approaches for the rehabilitation of gait~     in patients with PD within a multidisciplinary, intensive rehabilitation treatment (MIRT).~   "
41662|NCT03021395|"~     In this open-label, prospective clinical trial, the investigators enrolled acute myeloid~     leukemia (AML) patients after consolidation therapy. Patients with minimal residual disease~     (MRD) receive decitabine treatment if patients do not receive stem cell transplantation. The~     MRD clearance rate is the primary outcome to measure the efficacy of decitabine regimen.~   "
41663|NCT03021382|"~     The objective of this study is to evaluate the precision of semi-automated lumen boundary~     identification from coronary computed tomography angiography (cCTA) by current version of~     HeartFlow software and the impact on fractional flow reserve (FFRCT) by using optical~     coherence tomography (OCT) as reference standard.~   "
41664|NCT03021369|"~     The digital pleural drainage system Topaz+ by Medela is compared to the analogue system~     Atrium OCEAN by Maquet in patients undergoing cardiac surgery.~      The study is prospectively randomized with an all-comer setup. The patients are randomly~     selected for one of the systems. The surgery is performed in the standard fashion and chest~     tubes are placed routinely by the surgeon depending on the type of surgery. A retrosternal 32~     French drain is placed in every patient and pericardial and/or pleural drains are optional.~      The postoperative course does not vary from the clinical standard and the chest tubes are~     removed according to institutional standard. The clinical data about fluid amount, time of~     removal, air leaks, tamponade are routinely collected in a digital patient documentation~     system.~   "
41665|NCT03021356|"~     The hemodynamic performance of two supraannular aortic xenografts (Trifecta, St. Jude Medical~     and Perimount Magna Ease, Edwards Lifescience) will be compared using rest- and stress~     echocardiography in a randomized prospective study. Furthermore, the prostheses' influence on~     postoperative outcome will be compared using spiroergometry, quality of life questionnaire~     and heart failure biomarkers.~   "
41666|NCT03021343|"~     This study evaluates the role of colchicine in the prevention of atrial fibrillation in~     patients undergoing open heart surgery. Half of participants will receive colchicine and the~     other half will not~   "
41668|NCT03021317|"~     ACTHAR is a FDA approved drug for MS relapses. The purpose of the study is to examine the~     efficacy of this agent in improving relapses as measured by advanced MRI and laboratory~     techniques:~        1. Advanced serial MRI studies on patients during and after an acute MS relapse. MRI will~          be performed at baseline, 1 month after the 1st dose of ACTHAR, and months 3, 6, and 12.~          ACTHAR will be administered for 10 days. Patients will start ACTHAR within 48 hours of~          relapse assessment.~        2. Serial immune assays on patients during and after an acute MS relapse. Serum and blood~          samples with be collected at baseline, last day of ACTHAR (day 10 of therapy), 1 month~          post 1st dose, and months 3 and 6.~   "
41669|NCT03021304|"~     This study is aimed to assess the correct real-world use of a safety syringe for the repeat~     self-administration of mepolizumab SC. This Phase III study will be an open-label,~     single-arm, repeat-dose, multi-centre study of mepolizumab liquid drug product in a safety~     syringe (100 milligrams [mg]) administered subcutaneously (SC) every 4 weeks (3 doses) in~     subjects with severe eosinophilic asthma. Subjects will receive 100 mg mepolizumab SC as a~     single injection that is self-administered in the thigh, abdomen or administered in the upper~     arm (caregiver only). Each subject will participate in the study for up to 18 weeks including~     pre-screening visit, a screening visit and a 12-week treatment period which concludes with~     end of study assessments (Visit 5) 4 weeks after the last dose of mepolizumab. Approximately~     55 Subjects will be enrolled in the study.~   "
41670|NCT03021291|"~     This study is designed to assess the effect of Gelesis100 on body weight after an additional~     exposure of 24 weeks in subjects who completed the 24-week treatment period, and had at least~     3% weight loss, in the Gelesis Loss Of Weight GLOW, NCT02307279) study.~   "
41671|NCT03021278|"~     The purpose of this study is to determine whether experimentally induced acute low back pain~     might lead to alteration in lumbar tactile acuity measured in region affected by pain~     compared to pain-free side and pain-free controls.~   "
41672|NCT03021265|"~     Study to evaluate real-world safety, effectiveness and appropriate use of Micatrio®~     Combination Tablets treatment in patients with hypertension~   "
41673|NCT03021252|"~     Clinical randomized clinical trial to assess the effectiveness of incorporating inspiratory~     and expiratory muscle training (IEMT) in the rehabilitation of stroke patients with dysphagia~     in terms of functional outcomes, comorbidities, survival and quality of life.~      This project also incorporates a longitudinal study to assess the clinical impact of~     dysphagia on body composition and nutritional status in stroke patients.~   "
41674|NCT03021239|"~     The main purpose of this study is to compare Echo-guided testing to the Hemodynamic-Echo Ramp~     Tests to determine which method of testing provides better information for adjusting pump~     speed and medical treatment for Left Ventricular Assist Device (LVAD) patients. Better~     adjustments may provide better quality of life, exercise tolerance and reduced unwanted~     cardiac events over a 6-month period.~   "
41675|NCT03021226|"~     The Brothers United Fatherhood Program (BUFP) will be conducting an evaluation that builds on~     literature and existing research from the healthy marriage/responsible fatherhood initiatives~     developed by ACF over the last 10 years, in particular the Supporting Healthy Marriage~     Program initiative that established a randomized clinical trial. The Brothers United~     Fatherhood Program will provide important data to expand the area of fatherhood development~     with the target population. This program is funded through an initiative of the~     Administration for Children and Families, Office of Family Assistance (OFA).~      The study is intended to measure if the identified interventions improve the well-being and~     relationship between targeted participants and their families. The study intends to focus on~     the following outcomes:~        -  Demonstrate increased intake & knowledge of systems that help fathers~        -  Improvement in knowledge of employment & learn new opportunities for economic mobility~        -  Improvement communication & empathy skills towards partner~        -  Increase in understanding of healthy marriage & its value to fathers~        -  Demonstrate an understanding of financial planning~        -  Demonstrate improved conflict resolution, behavior patterns, including those leading to~          domestic violence~        -  Increase in reports of improved adult & child relationships~        -  Demonstrate an increase job readiness skills such as employment preparedness & career~          direction~   "
41676|NCT03021213|"~     Enhanced external counterpulsation (EECP) is an outpatient coronary artery disease (CAD)~     therapy that involves the cyclical inflation/deflation of cuffs wrapped around the lower~     extremities. However, the possible benefits of EECP in patients with heart failure (HF) (New~     York Heart Association [NYHA] classes II to IV) and cardiomyopathy are unclear.~   "
41677|NCT03021200|"~     The use of fluorescence for real-time evaluation of organ and tissue vascularization and~     lymph node anatomy is a recent technology with potential for the surgical treatment of~     cancer. The real-time analysis of tissue vascularization allows immediate identification to~     the surgeon of areas with greater or lesser blood circulation, favoring surgical decision~     making and prevention of complications related to tissue ischemia (necrosis, dehiscences and~     infections). It is a technology with potential application in the areas of Digestive Surgery,~     Repairing Plastic Surgery in Oncology, Head and Neck Surgery. In addition, fluorescence can~     be used as a method to identify lymph node structures of interest in the oncological~     treatment of patients with urologic, gynecological and digestive tumors.~      Introduced by Pestana et al. In the late 2000s, the perfusion mapping system through~     intraoperative indocyanine assisted laser angiography (SPY Elite System © LifeCell Corp.,~     Branchburg, N.J.) had its initial application in repairing surgery after breast cancer~     treatment. The method proved to be useful in the prevention of ischemic and infectious~     complications in cancer surgery. Pestana, in a prospective clinical series of 29~     microsurgical flaps used in several reconstructions, observed a single case of partial loss~     of the flap, the present technology having a relevant role in intraoperative decision making.~     In the same year, Newman et al. The first application of the system in breast reconstruction~     surgery. In an initial series of 10 consecutive cases of reconstruction with microsurgical~     flaps, in 4 cases the system allowed the intraoperative identification of areas of low~     perfusion, thus changing the surgical procedure. According to the authors, there was a 95%~     correlation between indocyanine laser assisted and subsequent development of mastectomy skin~     necrosis, with sensitivity of 100% and specificity of 91%. Similarly, Murray et al. Evaluated~     the intraoperative perfusion, however, of the areola-papillary complex in patients submitted~     to subcutaneous mastectomies with satisfactory results in terms of predictability of~     cutaneous circulation. Other authors in larger clinical series and evaluating other~     procedures have observed valid results in terms of prevention of complications.~      Vascular perfusion of anastomoses and fistulas following bowel surgery for cancer remain a~     serious and common complication. These fistulas can be caused by insufficient perfusion of~     the intestinal anastomosis. Intraoperative angiography with indocyanine assisted laser can be~     used to visualize the blood perfusion following intravenous injection of the indocyanine~     green contrast. Several groups reported the ability to assess blood perfusion of the~     anastomotic area after bowel surgery. Although they studied retrospectively, Kudszus and~     colleagues described a reduction in the risk of revision due to fistula in 60% of patients~     whose anastomosis was examined using laser fluorescence angiography compared to historically~     paired patients without this method. The same principle can be used to evaluate the tubulized~     stomach to be transposed to the cervical region after subtotal esophagectomy.~      Currently, fluorescence-guided sentinel lymph node mapping has been studied in breast cancer~     as well as investigative character in colorectal cancer, skin cancer, cervical cancer, vulvar~     cancer, head and neck, lung cancer, penile cancer, cancer Endometrial cancer, gastric cancer~     and esophageal cancer.~      These early studies demonstrated the feasibility of this methodology during surgery.~     Comparison of laser fluorescence images on blue dyes indicate that fluorescence images can~     replace blue dyes because they exceed them due to increased tissue penetration depth and~     absence of staining in the patient and cleaning of the operative field.~      To date, there are no clinical studies involving intraoperative perfusion mapping and~     identification of lymph node structures with the SPY Elite System © system or other platforms~     (Pinpoint or Firefly) in Brazil that evaluate the Brazilian population. In an objective way~     the influence of this technology as predictive in the better or worse evolution of the~     oncologic surgery as well as in the prevention of the local ischemic complications by means~     of intraopeal change of conduct~   "
41678|NCT03021187|"~     This trial is conducted globally. The aim of the trial is to investigate the efficacy and~     safety of oral semaglutide versus placebo in subjects with Type 2 Diabetes Mellitus treated~     with insulin. All subjects should continue their pre-trial insulin therapy (basal,~     basal-bolus or premixed regimen including combinations of soluble insulins) throughout the~     trial. Subjects treated with metformin in addition to insulin treatment must continue their~     metformin treatment throughout the entire trial.~   "
41679|NCT03021174|"~     This is a feasibility pilot study to initiate a research program to assess the effects of~     exercise on chemotherapy-induced peripheral neuropathy (numbness, tingling, and pain in the~     hands and feet).~   "
41680|NCT03021161|"~     This project will be test the effect of probiotics on occupational allergic sensitization,~     respiratory symptoms and bronchial hyperresponsiveness in workers or students that develop~     respiratory symptoms exposed to laboratory animals, i.e., small rodents.~   "
41700|NCT03020901|"~     1. Primary study endpoint Security Effectiveness~        2. Secondary study endpoint Extensive use of population characteristics Clinical drug~          characteristics appropriate crowd characteristics Adverse reactions susceptible~          population characteristics Reveal rare, new, unanticipated and long-term adverse drug~          reactions bacterial resistance Explore the advantages of teicoplanin in combination with~          other antimicrobial agents Explore the opportunistic use of teicoplanin for injection~   "
41701|NCT03020888|"~     The purpose of this post-marketing study is to provide prospective evidence that the Magseed~     and Sentimag® is effective for lesion localization in patients undergoing surgical excision~     of a breast lesion and to summarize measures of product safety and performance.~   "
41681|NCT03021148|"~     It has been reported that a consistent percentage of the general population consider~     themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though~     they do not have celiac disease or wheat allergy. This clinical condition has been named~     Non-Celiac Gluten Sensitivity' (NCGS). In a previous paper the investigators suggested the~     term 'Non-Celiac Wheat Sensitivity' (NCWS), since it is not known what component of wheat~     causes the symptoms in NCGS patients, and the investigators also showed that these patients~     had a high frequency of coexistent multiple food hypersensitivity. To our knowledge, there~     are very few studies which assessed the prevalence of self-reported gluten-related symptoms~     in the community and analyze diagnostic outcomes in those referred to secondary~     gastrointestinal care. In one of these, performed in UK, the authors showed that~     gluten-related symptoms are self-reported by 13% of the population, with 3.7% consuming a~     gluten-free diet, despite only 0.8% being aware that they have a formal diagnosis of celiac~     disease. Of those patients presenting to the gastroenterology department, the majority do not~     have CD but NCWS. No data are available for boys and girls. Therefore, the aims of this study~     were 1) to determine the prevalence of self-perceived gluten-sensitivity in a population of~     high-school students, and 2) to evaluate the demographic and clinical differences between~     students self-reporting gluten sensitivity and students not reporting food hypersensitivity.~   "
41682|NCT03021135|"~     Randomized, comparative and prospective study between Conventional Endoscopic Mucosal~     Resection for the removal of flat or sessile colorectal lesions without previous attempt to~     resection.~   "
41683|NCT03021122|"~     The investigators recruit nurses working in 5 swiss Pediatric Emergency Departments or~     divisions to prepare continuous infusions of vasoactive drugs during a simulation-based~     pediatric CPR cardiac arrest scenario. According to randomization, nurses will have to~     prepare and deliver vasoactive drugs following their current conventional methods or by the~     aim of a mobile tablet application called PedAMINES™. PedAMINES™ is designed to support them~     step-by-step from order to delivery of these drugs.~        1. Primary outcome will be to measure in each allocation group the number of medication~          dosage errors committed during each drug preparation sequence until injection.~        2. Secondary outcome will be to measure the time to drug preparation (TDP) and time to drug~          delivery (TDD).~   "
41684|NCT03021109|"~     The purpose of the study is assessment of volume status by bedside ultrasound in children~     with acute gastroenteritis~   "
41685|NCT03021096|"~     This study aims to identify the timeline of pain following total shoulder replacement with~     the goal of developing data for a subsequent randomized trial. The investigators believe that~     with using HSS's current protocol, many patients have postoperative pain that is no worse~     than their preoperative pain. Previous HSS anesthesia protocols for total shoulder~     arthroplasty patients have not formally followed patients past their hospital discharge, and~     the investigators believe that some patients do experience moderate to severe subacute~     postoperative pain. Therefore, this study's primary outcome is to look at the numeric pain~     scores at 14 days after surgery. Future studies will look at measures of preventing bruising~     and subsequent pain after shoulder replacement.~   "
41686|NCT03021083|"~     The treatment of postoperative pain continues to be a challenge after posterior spinal~     fusions. There is considerable evidence demonstrating that a multi-modality approach~     including patient controlled analgesia (PCA) with opioids for postoperative pain management~     compared to conventional opioid analgesia provides a greater analgesic effect even when the~     amount of opioids consumed is similar between both groups. However, the PCA modality is often~     discontinued prior to all the patients' pain needs being met. The IONSYS system uses the~     concept of PCA-delivered narcotics and may be used for postoperative pain management.~   "
41687|NCT03021070|"~     Antenatal care (ANC), facility delivery and postnatal care (PNC) are proven strategies that~     can tackle the high burden of maternal and child mortality and morbidity currently witnessed~     in sub-Saharan Africa. However very few pregnant women utilize these services. This study~     aims to assess the impact, cost-effectiveness, and scalability of conditional cash transfers~     (CCTs) to promote increased and uninterrupted contact between pregnant women and the formal~     healthcare system in Siaya County, Kenya.~      The study is a cluster randomized controlled trial with the intervention being a conditional~     cash transfer to women each time they honour their health appointments for ANC, facility~     birth and PNC visits until their new-borns reach 1 year of age. Study participants are~     pregnant women identified during their first ANC visit (n = 7200), and their subsequent~     new-borns. Mothers and their children are followed up throughout their health visits and at 3~     additional time points. Trial clusters are 48 public primary health facilities, (24 in the~     intervention arm and 24 in the control arm).~      The primary outcomes are: a) proportion of all eligible ANC visits made during pregnancy; b)~     delivery at health facility; c) proportion of all eligible PNC visits honoured; d) proportion~     of referrals honoured during pregnancy and postnatal period; e) proportion of child~     immunizations received. Secondary outcomes include; health screening and infection control,~     live birth, maternal and child survival 48 hours after delivery, exclusive breastfeeding,~     birth spacing and self-rated wellness of mother and new-born at respective time points.~      Primary outcomes will be measured through abstraction of health records at the health~     facilities attended by the women during the trial period and supplemented by data collection~     using an electronic based system that comprises of a card and reader system installed at~     recruited study facilities. Secondary data will be abstracted from the women's medical~     records at the health facilities and supplemented by telephone surveys administered at three~     time-points over the course of the study. Additional quantitative and qualitative data will~     be collected through questionnaires and phone interviews for process and economic~     evaluations.~      This trial will contribute to evidence on effectiveness and cost-effectiveness of conditional~     cash transfers in facilitating health visits and promoting maternal and child health in Kenya~     and other similar contexts.~   "
41688|NCT03021057|"~     Conventional chemotherapeutic regimens designed for aggressive B-cell lymphomas are generally~     less effective when applied to mature T-cell or NK-cell lymphomas. The treatment outcome for~     relapsed or refractory disease is especially poor.~      This is a single centre, prospective, non-randomized, open-label, phase II study to evaluate~     the efficacy of pembrolizumab in patients with relapsed or refractory mature T-cell or~     NK-cell lymphomas. Patients will receive pembrolizumab 200mg i.v. once every 3 weeks until~     disease progression or unacceptable toxicity.~      A baseline radiological assessment by positron emission tomography / computed tomography~     (PET/CT) scan is obtained before commencement of treatment. Tumor response and progression~     are evaluated by physical examination, standard laboratory tests, and PET/CT scan according~     to standard criteria. Standard response criteria for non-Hodgkin lymphomas are used for~     assessment . PET/CT scan will be done at week 12, week 24, week 36 and every 18 weeks~     thereafter.~   "
41715|NCT03020706|"~     The purpose of this study is to evaluate the effect of magnesium sulphate on~     neostigmine-induced reversal of neuromuscular block by rocuronium~   "
41716|NCT03020693|"~     This study evaluates the effectiveness of an electrostimulation treatment with TENS using a~     needle and a surface electrode combined with an exercise program to fasciitis plantar. Half~     participants will receive invasive electrostimulation (TENS using a needle) and exercises~     while the other half will receive electrostimulation placebo and exercises.~   "
41689|NCT03021044|"~     RATIONALE AND OBJECTIVE OF THE STUDY~      Patients with low functional capacity (frail patients) with cardiovascular disease, in~     particular those undergoing invasive procedures or suffering from coronary artery disease,~     have a much higher adverse events, death and re-hospitalizations. and complications,~     suggesting the need for a more accurate functional stratification and a more careful~     evaluation of the risk/benefit ratio of some invasive procedures. An early and ad hoc~     physical activity intervention could be improve functional autonomy of these patients early~     after discharge with benefit on long-term outcome. The present study is performed to assess~     the impact, evaluated by Short Physical Performance Battery (SPPB), of a program of physical~     activity early after discharge in elderly patients aged 75 years and older with low physical~     performance.~      This is an interventional, multicenter, prospective, randomized, phase III study. The present~     study is expected to enroll elderly patients admitted to hospital for acute coronary syndrome~     undergoing percutaneous coronary angioplasty and stratified with SPPB score predischarge. At~     the moment of discharge there will be a screening: patients with SPPB score 0-2 o 10-12 will~     be exclusively followed up by clinical visit every year. Patients with SPPB score 3-9 will be~     evaluated during the inclusion visit when SPPB will be repeated. If SPPB score will be 0-3 or~     10-12, patients will be considered screening failure and will be followed up by clinical~     visit; patients with SPPB score between 4 to 9 will be randomized to standard of care (see~     below) or to an ad hoc physical activity program (see below). The aim of the study is to~     demonstrate 6 months later an improvement in the SPPB score (at least 1 point) in patients~     randomized to physical activity intervention versus patients randomized to standard of care.~     All patients will be evaluated until 3 years after randomization.~   "
41690|NCT03021031|"~     The goal of this project is to provide comprehensive longitudinal assessments of a cohort of~     PD patients before, during, and after DBS surgery, including neurological,~     neurophysiological, and neuropsychological data.~   "
41691|NCT03021018|"~     The purpose of this study is to assess the efficacy of intravenous brivaracetam (BRV)~     compared to intravenous lorazepam (LZP) in subjects with epilepsy undergoing Epilepsy~     Monitoring Unit (EMU) evaluation who experience seizures that require prompt treatment.~   "
41692|NCT03021005|"~     The proposed pilot research has three aims: 1) to determine the feasibility and acceptability~     of provision of HIV self-testing kit in order to increase uptake and engagement of HIV~     testing among emergency department patients who decline conventional emergency department HIV~     testing and to increase the engagement of HIV testing at a regular basis for those with an~     increased risk for HIV (the index participants); 2) to determine the uptake and engagement of~     HIV testing by provision of HIV self-testing kit; and 3) to determine the feasibility and~     acceptability of HIV self-testing kit referral among partners or peers of the index~     participants.~      The investigators will conduct a pilot randomized study at Johns Hopkins Hospital emergency~     department on (1) patients who decline routine HIV testing offer and (2) patients who are at~     an increased risk for HIV. The consented patient will be randomized to HIV self-testing kit~     group which the investigators will provide a free Food and Drug Administration-approved HIV~     self-testing home kit for the participant to take it home or to reference group which the~     investigators will not provide the self-testing kit. Consented patients in both groups will~     fill out a short survey regarding their socio-demographic information as well as their~     experience and perceptions regarding HIV testing. For patients who are in the HIV~     self-testing kit group, they will be asked if they would like to take a free HIV self-testing~     home kit home. Participants in this group will also receive information regarding how to~     access I Want The Kit website to report the completion of HIV self-testing at home. For~     patients who are in the reference group, a standard pamphlet regarding the importance of HIV~     testing and HIV testing venues in Baltimore City used by emergency department-based HIV~     testing program will be provided to the patients.~      Follow-up questionnaires will inquire regarding the patient's experience regarding HIV~     testing since their index visit.~      When the participants in the HIV self-testing kit group in Aim 1, they will also be provided~     5 referral cards for their partners and peers for them to request a free HIV self-testing kit~     from the I Want The Kit website. At the 1-month phone follow-up, the investigators will ask~     participants if they are able to give the referral cards to their partner(s) or friend(s),~     how they think if their partner(s) and/or friend(s) will request an HIV self-testing kit from~     the I Want The Kit website.~   "
41693|NCT03020992|"~     The purpose of the study is to demonstrate the effect of Certolizumab Pegol (CZP) treatment~     on the reduction of Anterior Uveitis (AU) flares in subjects with active axial~     Spondyloarthritis (axSpA) and a documented history of AU~   "
41694|NCT03020979|"~     Malignant ascites is a severe complication of many types of human cancer. Animal and clinical~     analyses have shown that angiogenesis plays a critical role in the formation of malignant~     ascites. Therefore, drugs such as apatinib that target angiogenesis may control the~     development of malignant ascites. The study is to evaluate the efficacy and safety of~     apatinib in patients with refractory malignant ascites.~   "
41695|NCT03020966|"~     The purpose of this study is to determine how well two different methods of administrating~     Tylenol reduce pain and improve patient satisfaction after total hip replacement (THR)~     surgery. The methods of administration are orally, via a pill that is to be swallowed, and~     intravenously. Our aim is to determine whether oral or intravenous administration of Tylenol~     will reduce opioid consumption and opioid-related side effects after THR.~   "
41696|NCT03020953|"~     Purpose: to study the effect of estrogen replacement on muscle hypertrophy in response to 12~     weeks resistance training in postmenopausal women Hypothesis: Transdermal administration of~     17-β estradiol enhance the anabolic effect of resistance training on muscle mass, strength in~     postmenopausal women Primary outcome: Muscle hypertrophy (muscle CSA, muscle fiber type~     specific CSA) Secondary outcome: Messenger RiboNucleic Acid (mRNA)(real-time PCR), protein~     (western blotting), satellite cell proliferation and activation, Strength, functional test,~     muscle protein synthese.~      Design: Two groups of healthy postmenopausal women (½-5 years after menopause) who have not~     performed regular resistance exercise (<1 times per week) the last two years. Randomized,~     controlled intervention study +/- transdermal administration of estrogen (17-β estradiol).~     Both groups perform 12 weeks of supervised progressive resistance training (3/week) aiming to~     induce muscle hypertrophy in the legs.~   "
41697|NCT03020940|"~     1. National, large-scale, standardized, standardized, real-world research;~        2. Prospective, single - arm open, non - interventional, registration, multi - center~          clinical study;~        3. in the use of cefuroxime axetil dispersible tablets in the hospital, according to the~          principle of voluntary selection of 200;~        4. registration of the use of cefuroxime axetil dispersion tablets patients;~        5. Target sample size of 100,000 cases;~        6. Exemption from informed consent for ethical review applications;~        7. Antibiotic drug safety re-evaluation of large data.~   "
41698|NCT03020927|"~     The purpose of this study is to examine whether adding a parent education component to an~     existing intervention (Reciprocal Imitation Training) results in improved outcomes for~     children with Autism Spectrum Disorder. Reciprocal Imitation Training (RIT) is a behavioral~     intervention designed to improve spontaneous imitation skills in young children with Autism~     Spectrum Disorder (ASD). Previous research suggests that it can be effective when used by~     trained therapists, teachers, siblings, and parents of children with ASD. However, it is~     unclear to what extent training parents to use RIT strategies in the home environment may~     enhance outcomes, compared to having therapists implement RIT individually with the child.~     The study will compare two different versions of RIT for young children with ASD: (1) two~     60-minute weekly sessions of therapist-implemented RIT and (2) one weekly 60-minute session~     of therapist-implemented RIT and one weekly 60-minute session of parent education about using~     RIT in the home environment. The investigators will examine child and family outcomes between~     these two intervention types. Outcomes examined will include: (1) spontaneous and prompted~     imitation skills in the child with ASD, (2) social communication skills in the child with~     ASD, (3) parent stress, and (4) parent and child behaviors during parent-child play~     interactions.~   "
41702|NCT03020875|"~     The United States is currently experiencing an explosive opioid epidemic. In 2014 alone,~     28,647 Americans died from an opioid associated overdose; the annual death toll has increased~     by over 300% since 2000. The epidemic poses a complex scenario for physicians administering~     treatment for postoperative pain, as opioids are key analgesic agents in treating moderate to~     severe pain. In order to reduce the patients risk for long term opioid use and the associated~     side effects, physicians have begun shifting to multimodal analgesic approaches to treat~     postoperative pain. These approaches have been found to be similarly efficacious, while also~     reducing opioid usage and associated side effects, such as: nausea, vomiting, and ileus.~      This study proposes a multimodal analgesic approach, which the investigators believe will~     reduce short and long term opioid usage, the associated side effects, and the financial~     burden. Intravenous acetaminophen is an effective medication for both primary and adjunctive~     pain management, however its use is limited by a high cost to perceived benefit ratio. Oral~     acetaminophen is a relatively inexpensive option, although perhaps less effective than the IV~     option, and also often not feasible to utilize in the immediate post-operative period when~     patients are unable to safely swallow pills. The hypothesis of this investigation is to~     understand if adding intravenous acetaminophen to the perioperative care regimen after lumbar~     spinal surgery will result in improved pain management in the perioperative period while~     decreasing opioid usage and related complications.~   "
41703|NCT03020862|"~     The purpose is to evaluate exercise performance in patients with Chronic Obstructive~     Pulmonary Disease (COPD) after supplementing with higher doses of dietary NO3-, compared to~     previous studies, as beetroot juice for seven days. The secondary purpose is to evaluate~     oxygen consumption of submaximal cycling, amendments in blood pressure, and physical activity~     level.~   "
41704|NCT03020849|"~     In this retrospective and prospective study, the aim is to determine a score for predicting a~     fibrinogen <1.5g/L (corresponding to European threshold of Directors recommendations of~     fibrinogen concentrates)~   "
41705|NCT03020836|"~     Investigators conducted a clinic-based study to determine the magnitude of uncontrolled~     hypertension and current smoking in eye doctor's offices and sought to determine if referral~     to care results in actions taken by the patient.~   "
41706|NCT03020823|"~     The aim of this study is to evaluate the efficacy and safety of i.v. infusion for 24-hour of~     SCB01A in subjects with squamous cell carcinoma of head and neck who have failed previous~     platinum based therapies.~   "
41707|NCT03020810|"~     This is a single patient expanded access, compassionate and non-emergency use study that~     provides patients with severe asthma, who do not qualify for ongoing clinical trials with~     dupilumab, access to this investigational treatment.~   "
41708|NCT03020797|"~     This is a pilot trial to test perampanel (Fycompa; Eisai, Inc.) in ALS patients. The~     investigators will focus on safety and preliminary signs of efficacy. Perampanel is approved~     by the FDA for treatment of seizures in patients with epilepsy. In this study, perampanel~     will be used off-label for adults with ALS at an oral medication dose on the low end of the~     recommended dose range for epilepsy. This study will consist of two treatments arms:~     perampanel and matching placebo randomized at a 1:1 ratio. Subjects will receive medication~     for 9 months.~   "
41709|NCT03020784|"~     Safety, Tolerability and Pharmacokinetics of PF-06818883~   "
41710|NCT03020771|"~     This study covers the first trial of the Crimean-Congo Hemorrhagic fever virus (CKKA) vaccine~     on humans (healthy volunteers), which has been developed in Turkey and has completed~     preclinical toxicology studies to be performed on experimental animals. Also, this study is a~     Phase I, randomized, double-blind, national, single-center, placebo-controlled study that is~     designed to evaluate the safety and efficacy of the CKKA vaccine. A total of 60 (12 + 48)~     healthy male and/or female volunteers will be participating in this study, and the study is~     planned to last approximately one year.~   "
41711|NCT03020758|"~     This is a 2-period randomized crossover study with free-living subjects on self-selected~     diets. The objective of this study is to compare the effects of ¾ cup of a blend of dried~     plums, figs, dates and raisins (DPFDR) with an isocaloric and macronutrient matched snack~     food on blood pressure, vascular health and lipids and lipoproteins in 50 participants who~     are representative of the U.S. population and at risk for cardiovascular disease~     (overweight/obese, elevated LDL-cholesterol, prehypertension, and/or prediabetes).~      The investigators hypothesize that the inclusion of DPFDR in the diet will decrease blood~     pressure and LDL-cholesterol, and improve artery function (assessed by standard blood~     pressure measure, 24 hr ambulatory blood pressure, central blood pressure and arterial~     stiffness) compared to the control group and baseline.~   "
41712|NCT03020745|"~     GSK3389404 is being developed for the treatment of CHB virus infection. The development goal~     for GSK3389404 is the establishment of a finite duration treatment that results in sustained~     suppression of hepatitis B virus (HBV) replication and viral antigen production after~     cessation of all treatments for CHB due to the restoration of a functional immune response in~     the absence of high antigen levels. This study is a multicenter, randomized double-Blind~     (sponsor un-blinded in Part 1), Placebo-controlled Study which will evaluate the safety,~     tolerability, PK, and PD profile of GSK3389404 in subjects with CHB and aim to establish~     proof-of-mechanism. The study will be conducted in two parts. Part 1 plans to enroll subjects~     primarily from the Asia-pacific region, including Japan and will be conducted as a single~     ascending dose (SAD) study with 5 planned cohorts ranging from 30 milligram (mg) to a maximum~     of 240 mg GSK3389404. Within each cohort, subjects will be randomized to receive either~     GSK3389404 or placebo in a 3:1 ratio. Cohorts A, B, C, C1, and D will be conducted in a~     sequential fashion; Cohort C1 is an optional cohort and may be dosed after Cohort C or in~     parallel with Cohort D. Part 2 will be conducted as a multiple-dose, dose-ranging study.~     Subjects will be randomized to different parallel dose levels and regimens or placebo. The~     dose levels of Part 2 will be selected after a review of Part 1 safety, Pharmacokinetic (PK)~     and Pharmacodynamic (PD) data. The treatments selected are 60 mg GSK3389404 weekly, 120 mg~     GSK3389404 bi-weekly, 120 mg GSK3389404 weekly or placebo. An optional Japanese part-2~     sub-study is planned. The total study duration for part 1 including screening, treatment, and~     post-treatment follow-up, will not be expected to exceed 13 weeks for each subject and for~     part 2, including screening, treatment and post-treatment follow-up, will not be expected to~     exceed 65 weeks for each subject.~   "
41713|NCT03020732|"~     Platelet concentrates(PC) are used in the field of periodontology and implantology for the~     content necessary key cells and growth factors to accelerate healing and to provide~     regeneration. Concentrated Growth Factors(CGF) is defined as an innovative method or a new~     generation PC. The purpose of this clinical study was to evaluate the clinical effectiveness~     of Concentrated Growth Factor(CGF) membrane with coronally advanced flap(CAF) procedure's and~     subepithelial connective tissue graft(SCTG) with CAF in the treatment of multiple Miller~     class I gingival recessions (GR).~   "
41714|NCT03020719|"~     The purpose of this randomized, placebo-controlled (Phase II) study will be to further~     evaluate the effects of oral glutathione on growth in children with CF.~   "
41717|NCT03020680|"~     Coenzyme Q10 (or CoQ10) is a marketed supplement in US even though it can be synthesized in~     the body via complicated biochemical pathways. It exists in both reduced and oxidized states,~     namely ubiquinol and ubiquinone, respectively. It is commonly present in all cell membranes.~     The main function of CoQ10 is to participate in energy production. Further, the reduced form~     of CoQ10, ubiquinol, is appreciated as an important lipophilic antioxidant to protect free~     radical induced damages to DNA, lipid, and proteins. Given that older adults have increased~     production of free radicals, suboptimal antioxidant defenses toward free radicals, and a~     decreased capability to replenish utilized CoQ10, CoQ10 supplementation can be one of~     feasible ways to increase CoQ10 status in order adults. Most supplements available for~     consumers are in the oxidized form. While the ubiquinol form is also available, whether the~     reduced form will be more effective to replenish CoQ10 status in older subjects remains to be~     explored. Thus, investigators aimed to examine whether ubiquinol will be more effectively~     absorbed in older adults with a low antioxidant defense status. To pursue this aim,~     investigators will conduct a double blind, randomized, crossover design trail with 5 study~     visits (1 screening visit and 4 study visits). Ten older men (>55 y, BMI: 25-5 kg/m2) with a~     compromised antioxidant defenses will be recruited and complete the trial. Eligible subjects~     will be randomized to receive 200 mg/d ubiquinol or ubiquinone for 2 weeks with 2-week~     washout between crossover. Ubiquinol and ubiquinone in plasma and immune cells in blood will~     be assessed to reveal whether the reduced form, ubiquinol, is more absorbable than the~     oxidized form, ubiquinone in older adults.~   "
41718|NCT03020667|"~     The objectives and endpoints of this study will be analyzed in the study population of adults~     legally authorized to buy tobacco products. The study will describe the patterns of use of~     tobacco and nicotine containing products and self-reported health outcomes and health related~     events in CC (Cigarette) smokers and IQOS users in Japan.~      Note: The initial study record (posted to ClinicalTrials.gov) included a clinical sub-study~     designed to estimate population level differences in the biomarkers of exposure and clinical~     risk endpoints between iQOS users, CC smokers and never-smokers. However, due to low~     recruitment and retention of subjects, the clinical sub-study was terminated in May 2017 and~     the main study was terminated in March 2018. The study protocol was updated to remove the~     clinical sub-study objectives. This version of the study reflects the latest version of the~     updated study protocol.~   "
41719|NCT03020654|"~     This study investigates the use of virtual environments presented on a head mounted display~     for the rehabilitation of those suffering with visual vertigo.~      The control group and treatment groups will be presented with two different sets of~     environments and be given the same head and eye exercises to complete within the environment.~     They will also be provided with at home exercises to complete.~   "
41720|NCT03020641|"~     The investigators hypothesized that applying a low intraperitoneal pressure pneumoperitoneum~     (≤ 8mmHg) during laparoscopic cholecystectomy, the adverse impact on the surgical peritoneal~     environment (measured as gene expression of extracellular matrix, adhesion and inflammatory~     cytokine as well as oxidative stress response and apoptotic index), can be minimized and~     probably clinical outcomes might be better.~   "
41721|NCT03020628|"~     This study is a multi-center, randomized, double-blind Phase III Clinical trial. The purpose~     of this study is to assess the immunogenicity and safety of the quadrivalent cell~     culture-derived influenza vaccine compare to the trivalent cell culture-derived influenza~     vaccine in children aged 6~35 months.~   "
41722|NCT03020615|"~     This is a pilot study, single-blind, randomized, multicenter, therapeutic clinical trial~     designed to evaluate the feasibility of enrolling infants and toddlers (9 months to 36~     months) with sickle cell anemia (SCA; HbSS or HbSβ^0thalassemia), regardless of disease~     severity, to a therapeutic trial. A prior clinical trial at St. Jude Children's Research~     Hospital (SJCRH) (BABYHUG, NCT01783990) demonstrated that a fixed dose (20 mg/kg/day) of~     hydroxyurea was safe and effective in decreasing SCA-related complications in very young~     children (9-18 months), and largely due to these findings, hydroxyurea is recommended to be~     offered to all children (≥9 months old) with SCA, independent of disease severity.~     Nevertheless, children in the treatment arm of BABYHUG continued to experience vaso-occlusive~     symptoms and to incur organ damage. In clinical trials of older children with SCA,~     intensification of hydroxyurea to a maximum tolerated dosage (MTD), defined by mild to~     moderate myelosuppression, may be associated with improved laboratory parameters compared to~     fixed lower-dosing, but the clinical benefits gained from dose intensification have not been~     described. Therefore, in this trial, children in the standard treatment arm will receive a~     fixed dose of hydroxyurea (20 mg/kg/day), and participants in the experimental arm will~     receive hydroxyurea intensified to MTD, defined by a goal absolute neutrophil count (ANC) of~     1500-3000 cells/µL. This trial aims to establish a multicenter infrastructure that will~     identify, enroll and randomize very young children (9-36 months) to receive fixed dose versus~     intensified-dose hydroxyurea in a single blinded manner, and to obtain prospective pilot data~     comparing the clinical and laboratory outcomes between the treatment arms to facilitate~     design of a definitive phase III trial.~   "
41723|NCT03020602|"~     This phase I trial studies the side effects and best dose of ubidecarenone injectable~     nanosuspension (BPM31510) in treating patients with high-grade glioma (anaplastic astrocytoma~     or glioblastoma) that has come back and have been previously treated with bevacizumab.~     BPM31510 may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth.~   "
41724|NCT03020589|"~     Objective: Investigate the direct correlation of CYP3A5 genotype with tacrolimus trough~     levels and clinical outcomes. The primary endpoint of this study is to evaluate the~     proportion of patients reaching target levels (8-10 ng/mL) on Day 3 and Day 7 after kidney~     transplantation.~   "
41750|NCT03020251|"~     This randomized controlled trial will evaluate the effect of a preoperative rehabilitation~     program at home in patients resected for lung cancer, comparing a control group (C group)~     receiving only chest physiotherapy and a rehabilitation group (R group) receiving both a~     training program at home and chest physiotherapy~   "
41831|NCT03019185|"~     This international, multi-center, Phase 2/3 trial will study the safety, tolerability, and~     efficacy of bardoxolone methyl in qualified patients with Alport syndrome. The Phase 2~     portion of the trial will be open-label and enroll up to 30 patients. The Phase 3 portion of~     the trial will be double-blind, randomized, placebo-controlled and will enroll up to 180~     patients.~   "
41725|NCT03020576|"~     Weakness is a major cause of disability in stroke survivors. Rehabilitation techniques are~     often not effective in restoring full function of the upper limb. Specifically, many~     individuals remain with weakness in the hand, preventing its return to full use.~      Robotic therapies have been developed as exercise tools for stroke survivors. Devices, such~     as the InMotion2, have been shown to be useful in restoring some motor function in the upper~     limb. However, most existing devices designed to be used with the upper limb have primarily~     been developed to treat the shoulder, elbow and wrist. They have not specifically addressed~     hand function.~      Tyromotion, Inc. has developed the Amadeo, which is primarily intended to provide~     rehabilitation for patients with neurological or orthopedic deficits in hand function.~     Initial clinical testing has demonstrated the practicality of using this device in a~     population of stroke survivors, although further research is needed to better understand the~     usefulness of the Amadeo device as compared with conventional rehabilitation methods. The~     purpose of this study was to compare results of training with the Amadeo device or training~     with conventional therapies.~      A total of 28 subjects from two separate sites participated in the study and underwent~     baseline testing of upper limb motor and sensory performance and function. Subjects were then~     assigned to one of two treatment groups with a 50:50 chance of being in either group. One~     group underwent training with the Amadeo device and the other group underwent training with~     conventional therapy. All training sessions were 60 minutes in duration, three days/week for~     eight weeks (24 total sessions). Subjects were reassessed on completion of the training~     program.~   "
41726|NCT03020563|"~     To determine whether liposomal bupivacaine wound infiltration decreases pain scores and~     narcotic use when compared to bupivacaine alone after open reduction internal fixation of~     midshaft clavicle fractures.~   "
41727|NCT03020550|"~     This is a pilot study measuring physiologic and behavioral correlates of symptom severity in~     adult patients with gastroesophageal reflux disease (GERD).~   "
41728|NCT03020537|"~     In this exploratory study, investigators will be looking at immune response differences~     between age groups and between the two different vaccines given to identical twins and~     vaccine-naive young adults.~   "
41729|NCT03020524|"~     A single cohort, open-label pilot study of the safety and tolerability of a single infusion~     of autologous CD4+ T-cells genetically modified with an HR2, C34-peptide conjugated to the~     CXCR4 N-terminus using a lentiviral vector in HIV-infected subjects. This is a first in human~     study of C34-CXCR4 T cells~   "
41730|NCT03020511|"~     Recently it has been reported that a consistent percentage of the general population consider~     themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though~     they do not have celiac disease or wheat allergy. This clinical condition has been named~     Non-Celiac Gluten Sensitivity' (NCGS). In a previous paper the investigators suggested the~     term 'Non-Celiac Wheat Sensitivity' (NCWS), since it is not known what component of wheat~     causes the symptoms in NCGS patients, and the investigators also showed that these patients~     had a high frequency of coexistent multiple food hypersensitivity. It is also believed that~     this condition is worldwide increasing, due to the evolution of wheat breeding (i.e.~     consumption of wheats with high gluten content), and that ancient wheat flour varieties are~     better tolerated by NCWS patients than the modern ones. This effect could be related to a~     lower immunogenic stimulation of the ancient wheat than the modern ones. The aim of the study~     is to evaluate the effect of a diet based on ancient grains in a closed community (i.e.~     nuns from enclosed religious order) as regard to 1) main haematochemical parameters and~     vitamins, 2) intestinal microbiota (bacterial flora), and 3) cytokines production from~     peripheral blood mononuclear cells (PBMC), before and after the diet period (30 days) with~     ancient grains.~   "
41731|NCT03020498|"~     In this exploratory study, investigators will be looking at immune response differences~     between age groups and between the two different influenza vaccines given to identical twins,~     vaccine-naive young adults and elderly participants.~   "
41732|NCT03020485|"~     The objective of this study is to determine the glycaemic effect of isomaltulose and sucrose~     in Chinese, Indian, Malay, and Caucasian individuals. The current study will provide~     important information on the potential health benefits of isomaltulose consumption in Asian~     population. It will also reveal how the three main ethnicities in Singapore respond to~     isomaltulose and whether the response differs from the Caucasians.~   "
41733|NCT03020472|"~     This pilot study will investigate B-cell responses following vaccination with live,~     attenuated influenza vaccine (LAIV) in healthy children 2 years of age from blood samples~     taken at designated time points before and after vaccination.~   "
41734|NCT03020459|"~     To compare the morphologic and functional outcomes of internal limiting membrane~     peeling-reposition versus peeling in idiopathic macular holes~   "
41735|NCT03020446|"~     To follow the effectiveness of Sorbion Dressing in the treatment of highly exuding venous leg~     ulcers.~   "
41736|NCT03020433|"~     The investigators ultimate goal is to personalize brain stimulation for stroke so outcomes of~     the upper limb can be maximized for each individual patient. Several groups including the~     investigators have recently theorized that personalizing stimulation so as to selectively~     stimulate iM1 in mild, and cPMd in patients with greater severity would help generalize~     benefits of stimulation. The investigator premise that variances in expressions of plasticity~     can explain how to best stratify patients for robust, personalized stimulation.~   "
41737|NCT03020420|"~     This study tries to prove that Cicatricell cream significantly reduces scarring with better~     wound appearance as compared to no treatment.~   "
41738|NCT03020407|"~     The primary aim of this study is to evaluate the 30-day mortality outcome of the septic shock~     patients who are treated with ultrasound-assisted fluid management using change of the~     inferior vene cava (IVC) diameter during respiratory phases in the first 6 hours compared~     with those treated with usual-care strategy.~   "
41739|NCT03020394|"~     Preliminary studies have shown that NPPV can avoid tracheal intubation in 40% to 60% patients~     who have severe exacerbation of COPD. Recently, large-scale comparative effectiveness~     research (CER) also found that compared with invasive ventilation, NPPV can reduce mortality~     rates. But there's no high-quality clinical studies which can confirm this. Therefore,~     investigators believe that NPPV can avoid intubation in patients with severe exacerbation of~     COPD in ICU with perfect monitoring conditions and reasonable human resource allocation, in~     order to reduce IMV-related complications and improve patients' outcomes.~   "
41740|NCT03020381|"~     Motor slowing and cognitive slowing are more prevalent as we age. Importantly, the presence~     of both in an older person increases their risk of having dementia by ten times. Currently,~     there are no clinically meaningful predictors of progression to dementia in people with mild~     cognitive impairment (MCI). The main hypothesis is that subtle variations in gait while~     performing a simple cognitive task is a reliable, easy to perform, and feasible methodology~     to detect those older adults at higher risk of progression to dementia and also, at higher~     risk of further mobility decline and falls.~      Rationale. The Canadian population is aging. According to recent estimates, the proportion of~     the population aged 65 and older will increase rapidly from 13% in 2005 to 25% by 2031. This~     increase in proportion is accompanied by a considerable amount of disability and subsequent~     dependency which has major effects on both the quality of life of older adults and their~     caregivers, and on the Canadian health care system. An important goal of geriatric medicine~     is to reduce the gap between life expectancy and disability-free life expectancy by reducing~     disability and dependency in the later years of life. A substantial portion of this~     disability stems from two major geriatric syndromes: cognitive impairment and mobility~     limitation. The ultimate manifestations of these syndromes are dementia and falls.~     Interestingly, these manifestations often coexist in elderly people: falling is a common~     geriatric syndrome affecting about a third of older adults each year, and dementia affects~     about a third of Canadians aged 80 and over. Together, dementia and falls are responsible for~     much of the discomfort, disability, and health care utilization in older adults and each will~     become more prevalent as older Canadians are expected to number approximately $9 million by~     2031. The combined direct cost of dementia and falls for the Canadian Health System is over~     $4.9 billion per year.~      Establishing reliable and easy to obtain predictors to accurately identify MCI patients at~     highest risk of progressing to dementia is essential first, to determine who will benefit~     from additional and/or invasive testing and second, to implement preventative strategies,~     including cognitive training, physical exercises, and aggressive vascular risk factors~     correction to delay progression. Even a modest one-year delay in dementia incidence could~     save Canada $109 billion over 30 years.~   "
41741|NCT03020368|"~     In this trial the investigators want to prove the efficacy and safety of a one-time topical~     leech application at patients with symptomatic primary arthrosis of the first carpometacarpal~     joint in comparison to the standard therapy with topical diclofenac.~   "
41742|NCT03020355|"~     Comparison of effectiveness of placental blood drainage after spontaneous vaginal delivery in~     decreasing the duration, blood loss,and complications of the third stage, against no drainage~     of placental blood.~   "
41743|NCT03020342|"~     Early stage HCC is treated by curative surgical resection or by local ablation (such as~     radio-frequency) as the current standard of care. The complete removal of clinical visible~     HCC is then confirmed by imaging by MRI or CT, or by a decline of tumor marker (AFP or~     PIVKA). However, despite an apparent complete removal of the HCC, those post-curative~     patients frequently develop tumor recurrence at a rate ranging 10-50% within the first year.~     The high rate of early HCC recurrence indicated a minimal residual HCC after the curative~     therapies in a significant proportion of patients. A better and more specific biomarker for~     detecting the residual HCC will improve the patients' prognosis prediction and therapeutic~     plan.~      To detect the minimal residual HCC, a biomarker unique to the tumor is needed. Currently, the~     cell-free circulating DNA carrying tumor-specific somatic mutations has been advocated as a~     promising one. It has been applied to investigate the tumor responses or resistances to~     cancer therapy. However, currently it is restricted to detect or follow only large advanced~     cancer, because of the difficulty in separating or enriching the cfDNA with tumor-specific~     mutations from the cfDNA from normal cells. In this project, the investigators proposed that~     one class of somatic mutation in HBV-related HCC, namely the insertion mutagenesis by~     integrated HBV DNA, could be adopted to circumvent this difficulty. HBV DNA integration has~     been found in the chromosomes of about 90% of HBV-related HCC and the integration site is~     unique to individual HCC. The HBV-host junction DNA fragment from one HCC is therefore a~     tumor-specific biomarker. Such fragments can be released into the circulation as cell-free~     circulating DNAs, and the detection of the HBV-host chimera DNAs in the circulation is a~     reliable evidence for the presence of the tumor in the patient. Therefore the cf circulating~     HBV-host chimera DNA is proposed to assay any minimal residual HCC after curative therapies.~   "
41744|NCT03020329|"~     1. To see the effect if a combination of induction chemotherapy followed by chemoradiotherapy~     works in treating children with advanced nasopharyngeal carcinoma(NPC).~   "
41745|NCT03020316|"~     This study will be a pilot prospective randomized study of using a peer mentor with or~     without transcendental meditation as compared to usual care for women with newly diagnosed~     heart disease (coronary artery disease or CAD). The study is designed to explore the effect~     of these interventions on medication adherence and a number of additional outcomes. The~     results of this pilot study will be used in the design of larger future trials.~      The targeted population is for adult women with a new diagnosis of CAD made on the basis of a~     myocardial infarction or a coronary revascularization procedure requiring inpatient~     hospitalization at the New York-Presbyterian Hospital.~      The overall hypothesis of this proposal is that the addition of a peer mentor to usual care~     will improve self-reported medication adherence for women with newly diagnosed CAD as~     compared with usual care. The further addition of meditation sessions will provide further~     incremental benefit to medication adherence.~   "
41746|NCT03020303|"~     Individuals receiving dialysis are at risk of heart failure and heart related death. There is~     an urgent need for treatments that reduce the risk of these problems in patients that require~     dialysis.~      Spironolactone is a pill used to prevent heart failure and related deaths in patients that do~     not require dialysis. It works by blocking a hormone (aldosterone) in your body that causes~     high blood pressure and can damage the heart. Although spironolactone is very effective in~     patients that do not require dialysis, we do not know if spironolactone is effective in~     dialysis patients. Our research will help determine if spironolactone reduces heart failure~     and heart related deaths in dialysis patients.~      The purpose of this study is to determine if spironolactone reduces death or hospitalization~     for heart failure and is well tolerated in patients that require dialysis.~   "
41747|NCT03020290|"~     Endovascular treatment with stenting is currently used in the treatment of femoro-popliteal~     lesions. This technique tends to extend to lesions for which the gold standard remains until~     now the open surgery treatment (lesions TASC C and D).~      The primary objective of the study was to evaluate the clinical efficacy at 12 months of the~     SuperA stent (Abbott) in the treatment of long de novo atherosclerotic lesions TASC C and D~     in patients with symptomatic peripheral arterial disease. The secondary objectives are to~     evaluate the clinical effectiveness of the SuperA stent at 24 months, according to clinical,~     morphological and haemodynamic criteria, the possible influence of calcifications and the~     quality of life of patients.~      The SuperA stent treatment is not specifically provided for by the Protocol but is carried~     out within the framework of the care. This study is an observationnal study.~   "
41748|NCT03020277|"~     This is a prospective, longitudinal, exploratory, open study with a 6-month follow-up period~     to explore via a specific Smartphone© application the evolution of a child's behavior over 6~     months and the (psychological and social) effects of these changes on the family.~   "
41749|NCT03020264|"~     Diabetes is a chronic and progressive disease that affects nearly 3.5 million people in~     France.~      Currently the investigators are seeing an aging of the population explained by the increase~     in life expectancy and thus an increasing incidence of diabetes in the elderly. However, the~     frequency of hypoglycemia in older vulnerable patients remains poorly characterized~   "
41751|NCT03020238|"~     Background: Radical hysterectomy is an important therapy for early cervical cancer.~     Disfunction of urinary dynamics is the most common postoperative adverse effects, which had~     negative impact on patients' quality of life. Nerve sparing radical hysterectomy (NSRH) could~     reserve inferior hypogastric plexus (IHP) innervating bladder, hence improving postoperative~     urinary dynamics. Furthermore impact of different energy instruments on urinary dynamic isn't~     clear.~      Objectives: This study is to compare urinary dynamics before and after NSRH, and to analyze~     the difference between BiClamp forcep (BiClamp® forcep, ERBE Elektromedizin, GmbH, Tuebingen,~     Germany) and water jet (ERBEJET®2) about the effects of dissecting IHP.~      Study population: Cervical cancer of FIGO IB stage, among which 120 cases are enrolled to~     randomly allocated to BiClamp group or water jet group.~      Intervention: Patients accept NSRH which all will be accomplished by Professor Ming Wu.~      Methods: All surgical patients are accessed via urinary dynamics before and four months after~     NSRH. On the 14th day after surgeries, urinary catheter will be removed and residual urine~     volume (RUV) will be measured. For patients of RUV > 100 ml, urinary catheter will be~     replaced.~      Primary study endpoint: the successful rate of removing urinary catheter on the 14th day~     after NSRH.~      Secondary study endpoint: urinary dynamics four months after NSRH.~   "
41752|NCT03020225|"~     The investigators aim to test the protein bioavailability of new specific developed strain of~     duckweed [Wolffia globose, Mankai] , an aquatic plant, which might serve as a protein source~     and contains all the 9 essential and the 6 conditional amino acids. The investigators will~     randomize 36 participants to consume equivalent protein (30gr) content of 3 whole foods~     items: 1. White cheese (animal protein source, as a reference); 2. Green peas, intact, cooked~     (plant protein source); 3. Wolffia globosa (Mankai), intact, cooked (plant protein source).~     The foods will be consumed in the morning, following 12h fasting. The foods will be provided~     with 250ml mineral water and the blood follow-up frame will be for 3 hours. Primary outcome:~     Blood amino acid profile.~   "
41753|NCT03020212|"~     A clinical, prospective, randomized controlled trial to determine the effect of prescribing~     oxygen in a group of COPD (chronic pulmonary disease) patients with PaO2 (arterial oxygen~     tension) ≥50 and ≤55 mmHg who do not have erythrocytosis or pulmonary hypertension on~     echocardiogram (which are considered manifestations of chronic hypoxia)~   "
41754|NCT03020199|"~     The purpose of this study is to determine whether early intervention with subcutaneous (s.c.)~     secukinumab 300 mg in patients with new-onset moderate to severe plaque psoriasis may lead to~     prolonged symptom free periods by preventing reactivation of old lesions or ultimately~     totally hindering the occurrence of new lesions, i.e., changing the natural course of the~     disease (Main Study).~   "
41755|NCT03020186|"~     Mediterranean (MED) diet, richer in plants/seeds (and dietary polyphenols) and low in~     processed meat (green-MED diet) may have a pronounced beneficial effect on age-related~     declines that begin in middle age, reflected by changes in adiposity, cognitive function, and~     cardiometabolic risk. The investigators hypothesize that long-term intake of this diet will~     significantly potentiate the effects of a healthy lifestyle (physical activity and~     Mediterranean diet), constituting a powerful strategy to halt or even reverse the progression~     of several age-related processes related to adiposity, cardiometabolic health and cognition.~     The investigators further hypothesize that lifestyle intervention might modify the gut~     microbiota profile and that autologous fecal microbiota supplement derived from the time of~     maximal weight loss might halt the expected subsequent regain phase.~   "
41756|NCT03020173|"~     This study aims to discover the connection between BMI and oocyte and granulosa~     consistencies.~   "
41757|NCT03020160|"~     This multicenter, open-label, non-randomized study will assess the efficacy, safety,~     pharmacokinetics, and pharmacodynamics of emicizumab administered at a dose of 6 milligrams~     per kilogram (mg/kg) every 4 weeks in participants with hemophilia A with or without~     inhibitors against factor VIII (FVIII). The study consists of 2 parts: a pharmacokinetic (PK)~     run-in part followed by an expansion part.~   "
41758|NCT03020147|"~     The Randomized Control Trail included 4,172 low-birth weight children between February 2008~     and September 2013 in Bissau. The children who were included in the RCT and who are living in~     the Bandim Health Project study area will be visited. The study assistants will ask about the~     health of the child and of both parents. Furthermore, Bacille Calmette-Guerin (BCG) scar~     status of both child and parents will be checked.~   "
41759|NCT03020134|"~     The purpose of this study is to evaluate the Pharmacokinetics and safety of Ravidasvir in~     Combination with Ritonavir-boosted Danoprevir in Single and Multiple doses in Healthy~     Participants~   "
41760|NCT03020121|"~     The purpose of the study is to compare the results of the Becton Dickinson (BD) Human~     Papilloma Virus (HPV) Assay on the Viper LT instrument from Liquid-based cytology media~     diluted in HPV diluent to adjudicated histology results from biopsy.~   "
41761|NCT03020108|"~     The study population will comprise of 90 women age varying between 15-55 years, those are~     candidate for laparoscopic surgery due to definition of >4 cm endometrioma or any other~     benign ovarian cysts such as mature teratoma or simple serous cysts on ultrasound~     examination, chronic pelvic pain, infertility. The blood samples will be drawn for analysis~     of serum biomarkers.~   "
41762|NCT03020095|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of Ravidasvir~     (ASC16) in combination with Ritonavir-boosted Danoprevir(ASC08) and Ribavirin in~     treatment-naive no-cirrhotic Taiwanese patients who have chronic hepatitis C genotype1.~   "
41763|NCT03020082|"~     The purpose of this study is to evaluate the efficacy and safety of Ritonavir-boosted ASC08~     (Danoprevir) in Combination with Peg-IFN and RBV in Treatment-Naive Non-Cirrhotic Patients~     Who Have Chronic Hepatitis Genotype 1.~   "
41764|NCT03020069|"~     The purpose of this study is to determine that continuous glucose monitoring systems (CGMS)~     with intensive real time feedback about diabetes management from medical staff to the patient~     will affect motivation and/or behavior, in adolescents with poorly controlled type 1~     diabetes. Investigators hypothesize that short-term CGMS use with feedback (and/or lack~     thereof) and patients' sense of self-efficacy~   "
41765|NCT03020056|"~     This is a randomized controlled trial to investigate the effect of cataract surgery on the~     household socioeconomic status of cataract patients in rural area of Southern China.~   "
41767|NCT03020030|"~     Acute lymphoblastic leukemia (ALL) is the most common cancer diagnosed in children. The~     cancer comes from a cell in the blood called a lymphocyte. Normal lymphocytes are produced in~     the bone marrow (along with other blood cells) and help fight infections. In ALL, the~     cancerous lymphocytes are called lymphoblasts. They do not help fight infection and crowd out~     the normal blood cells in the bone marrow so that the body cannot make enough normal blood~     cells. ALL is always fatal if it is not treated. With current treatments, most children and~     adolescents with this disease will be cured.~      The standard treatment for ALL involves about 2 years of chemotherapy. The drugs that are~     used, and the doses of the drugs, are similar but not identical for all children and~     adolescents with ALL. Some children and adolescents receive stronger treatment, especially~     during the first several months. A number of factors are used to decide how strong the~     treatment should be to give the best chance for cure. These factors are called risk~     factors. This trial is studying the use of a new, updated set of risk factors to decide how~     strong the treatment will be. The study also will test a new way of dosing a chemotherapy~     drug called pegaspargase (which is part of the standard treatment for ALL) based on checking~     levels of the drug in the blood and adjusting the dose based on the levels.~   "
41768|NCT03020017|"~     The purpose of this research study is to evaluate the safety of the study drug, NU-0129,~     based on Spherical Nucleic Acid (SNA) platform when infused in patients with recurrent~     glioblastoma multiforme or gliosarcoma. The SNA consists of nucleic acids arranged on the~     surface of a small spherical gold nanoparticle. This is a first-in-human trial to determine~     the safety of NU-0129. NU-0129 can cross the blood brain barrier (a filtering mechanism that~     carry blood to the brain). Once within the tumor, the nucleic acid component is able to~     target a gene called Bcl2L12 that is present in glioblastoma multiforme, and is associated~     with tumor growth. This gene prevents tumor cells from apoptosis, which is the process of~     programmed cell death, thus promoting tumor growth. Researchers think that targeting the~     Bcl2L12 gene with NU-0129 will help stop cancer cells from growing.~   "
41769|NCT03020004|"~     The purpose of this study is to evaluate the Efficacy, Safety and Pharmacokinetics of~     Ritonavir-boosted Danoprevir (ASC08) in Combination with Peg-IFN and RBV in Treatment-Naive~     Non-Cirrhotic Patients Who Have Chronic Hepatitis Genotype 1.~   "
41770|NCT03019991|"~     The purpose of this study is to evaluate the Pharmacokinetics of Danoprevir in single dose~     (100mg QD on day 1, day 4 and day 14) and Ritonavir-boosted Danoprevir (100mg QD on day 4 and~     day 14) in single and multiple doses (100mg BID on day 5 -day 13) in healthy volunteers.~   "
41771|NCT03019978|"~     The proposed study will include an analysis of data for residents of Pennsylvania who are age~     21 and older, have a diagnosis of Autism Spectrum Disorder (ASD), and are enrolled in the~     Commonwealth's Adult Community Autism Program (ACAP). The individuals enrolled in the program~     will be administered a standardized assessment battery quarterly for two years. The proposed~     study will analyze the data gathered during each of the assessment periods in order to aid in~     service/treatment planning, assess for individual improvements, and ultimately measure~     treatment outcomes.~   "
41772|NCT03019965|"~     This study evaluates the efficacy and safety of the administration of betalactam antibiotics~     in prolonged infusion compared to intermittent infusion in children with sepsis. Half of~     participants will receive piperacillin/tazobactam, imipenem or meropenem in continuous or~     extended infusion, while the other half will receive piperacillin/tazobactam, imipenem or~     meropenem in intermittent infusion.~   "
41773|NCT03019952|"~     An analysis of data for adolescents and young adults diagnosed with Autism Spectrum Disorders~     (ASDs) who are evaluated as part of the Care Coordination, Assessment, and Responsive~     Engagement for transition-aged adolescents (t-CARE) program which replaced the former Autism~     Life Care Model (ALCM), which was a clinical program implemented between Fall 2014 and April~     2016. The individuals enrolled in the program will be administered a standardized assessment~     battery during each visit with the care coordinator or study coordinator. The proposed study~     will analyze data gathered during each of the assessment periods in order to check the~     efficacy and viability of the protocol.~   "
41774|NCT03019939|"~     You are being asked to take part in this study because you have acute myeloid leukemia (AML)~     or myelodysplastic syndrome (MDS) and are about to begin treatment for the same.~      Acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) and their treatment may weaken~     your immune system and may make you more likely to develop invasive fungal infections (IFIs).~      The goal of this clinical research study is to learn if isavuconazole can help prevent~     invasive aspergillosis (IA) and other IFIs in patients with AML/MDS. The safety of this drug~     will also be studied.~      This is an investigational study. Isavuconazole is FDA and commercially available for the~     treatment of IA and mucormycosis. It is considered investigational to use isavuconazole for~     the prevention of IFIs. The study doctor can explain how the study drug is designed to work.~      Up to 100 participants will be enrolled in this study. All will take part at MD Anderson.~   "
41775|NCT03019926|"~     A poor therapeutic observance is described between 3 and 76% cases in systemic lupus. It is~     associated with an increased risk of relapses, hospitalizations, morbidity and poor renal~     prognosis.~      New treatment protocols exist and are indicated in second intention in case of good~     compliance. An assessment of therapeutic adherence is therefore essential.~      Patients with systemic lupus diagnosed for at least 6 months, or skin lupus, who have been~     prescribed with Plaquenil (hydroxychloroquine), will be included in the study.~      The study primary objective is to determine risk factors for non-observance~      The secondary objectives are to:~        -  Measure the observance rate of patients with systemic lupus in Martinique.~        -  Describe the parameters that influence observance: evaluation of the disease and~          associated comorbidities, psychosocial assessment, assessment of the doctor-patient~          relationship, evaluation of the disease representations.~   "
41790|NCT03019731|"~     This research is being done to determine whether a home-based behavioral therapy can be~     successfully used to treat tics in children with Tourette syndrome (TS). Behavioral therapy~     administered by a trained therapist has been shown to be helpful in reducing tics in children~     with Tourette syndrome. In this study, the investigators want to determine whether an~     instructional video can provide parents of children with TS with the tools necessary to~     successfully use behavioral therapy at home. The investigators also want to determine the~     effectiveness of home-based behavioral therapy as compared to improvement achieved when the~     therapy is provided by a trained therapist.~   "
41776|NCT03019913|"~     Muscle wasting is a significant problem in critically ill patients, with reported losses of a~     half to three percent per day over the first ten days (for an average 70kg person this~     equates to 3 to 20kg of muscle loss). Low skeletal muscle mass at admission to the intensive~     care unit (ICU) and the loss of lean tissue have been associated with negative clinical~     outcomes, including increased incidence of infections, length of stay, mortality and muscle~     weakness. It is therefore crucial that technology is utilised to: 1) identify ICU patients~     with low muscularity on admission, 2) to help understand the factors impacting muscle loss~     and to 3) assess the effectiveness of interventions aimed at maintaining skeletal muscle mass~     in this population.~      The measurement of lean body mass in patients admitted to the ICU is challenging however, due~     to the large fluid shifts that occur in this population and logistical issues in moving~     patients to specialised machinery for body composition analysis. Currently, there is no~     validated method for accurately assessing a patient's muscle mass at the bedside in the~     intensive care setting. It is therefore important to investigate the accuracy, feasibility~     and reliability of bedside methods such as subjective physical assessment of muscle mass, mid~     arm muscle circumference, ultrasound and bioimpedance analysis to assess muscularity in this~     population who are primarily bedbound. In order to do this, a critical comparison is required~     between these methods and muscularity assessed by a reference body composition method, such~     computed tomography (CT) image analysis. Briefly, quantification of skeletal muscle at the~     abdomen area utilising abdominal CT images has been shown to be highly representative of~     whole body skeletal muscle volume.~      We wish to conduct a pilot, feasibility study (n= 50), which will recruit patients who have a~     CT scan (containing abdomen area), performed for clinical purposes. Our primary aim will be~     to investigate whether muscularity assessed with non-invasive bedside methods (ultrasound,~     bioimpedance analysis, SGA physical assessment, mid arm muscle circumference) are correlated~     with skeletal muscle mass quantified by a reference method (CT image analysis).~   "
41777|NCT03019900|"~     The purpose of this study is to describe current practice on red blood cell transfusion in~     critically ill patients of intensive care units located in high altitude areas~   "
41778|NCT03019887|"~     To reduce antipsychotics to under 1000mg in patients with schizophrenia taking more than~     1000mg/day and to evaluate relationship between relapse and cognitive function.~   "
41779|NCT03019874|"~     The main focus of this observational study is to analyze the possible effects of cranberry~     dietary supplements on the intestinal microbiota in women with recurrent uncomplicated~     urinary tract infections. In a secondary analysis the possible influence of the microbiota~     changes on the recurrence frequency in the follow-up should be analyzed.~   "
41780|NCT03019861|"~     The main goal of this randomized, controlled clinical pilot study is to evaluate the efficacy~     of an individual Ayurvedic nutritional counseling (according to tradition) compared to an~     individual conventional dietary advice (according to the German Nutrition Society - DGE) in~     patients with irritable bowel syndrome. It is to be investigated whether nutritional therapy~     elements, which patients can self-implement independently in the home environment, can~     achieve sustainable therapy effects.~   "
41781|NCT03019848|"~     The purpose of this study is to determine if the oral supplementation with curcumin reduces~     proteinuria, improves the redox and pro-inflammatory state in patients with chronic kidney~     disease associated to Diabetes mellitus.~   "
41782|NCT03019835|"~     The antagonism of neuromuscular blocking agents (NMBA) (or curares), as well as the~     antagonism of other drugs used in anesthesia, is a major challenge for the speciality.~      Residual paralysis is indeed a risk factor for post-operative morbidity and mortality and~     antagonization of curares at the end of the procedure is associated with a reduction in~     mortality .~      Its use should be as large as possible and its contraindications are extremely rare.~      The antagonism of the NMBA reduces the duration of the neuromuscular block and the~     complications that are associated .~      In this study, the investigators use mivacurium (or Mivacron) as non-depolarizing curare and~     neostigmine as an antagonist.~      Neostigmine reduces the duration of the neuromuscular block induced by mivacurium, By~     reducing the breakdown of acetylcholine, neostigmine induces an increase in acetylcholine in~     the synaptic cleft which competes for the same binding site as nondepolarizing neuromuscular~     blocking agents, and reverses the neuromuscular blockade.~      But the use of neostigmine in current practice is not very widespread in this clinical~     situation.~      The reduction in the duration of the block is significant in comparison with a spontaneous~     recovery .~      Moreover, spontaneous recovery is not always complete and sometimes very long.~      Nevertheless, its action is effective and this study could support this use but also specify~     the duration and the quality of the return to normal of the neuromuscular transmission.~   "
41783|NCT03019822|"~     The study will test the effect of dopamine, serotonin, and direct 5-HT2A receptor stimulation~     on empathy, mood perception, and amygdala activity to fearful stimuli. In addition, we~     predict associations between subjective effects/alterations in emotion processing tests and~     functional imaging (fMRI) activity.~   "
41784|NCT03019809|"~     Treatment Study to assess of safety and efficiency of conditioning with Plerixafor and G-CSF~     as additional agents for prevention of graft failure after transplantation with TCR~     alpha/beta grafts depletion in patient with Wiskott-Aldrich syndrome.~   "
41785|NCT03019796|"~     To analyze the effects of different exercise training modalities (continuous, intervallic,~     and resistance training) on cardiorespiratory and metabolic fitness of metabolic syndrome~     patients when this training interacts with their habitual medication.~   "
41786|NCT03019783|"~     The investigators hypothesize that older subjects with HIV randomly assigned to atazanavir~     will have increased bilirubin levels, reduced oxidative stress, and improved flow-mediated,~     endothelium-dependent vasodilation compared to subjects not switched to atazanavir.~   "
41787|NCT03019770|"~     The purpose of this study is to test a clinical Decision Aid that will help patients and~     providers determine if pre-exposure prophylaxis (PrEP) is the right decision. The Decision~     Aid will be tested in both clinical and non-clinical settings with 80 patient-provider dyads.~     The investigators hypothesize that the use of the Decision Aid will reduce patient decisional~     conflict. The investigators predict that it will increase patient and provider knowledge of~     and intent to initiate PrEP.~   "
41788|NCT03019757|"~     The study is designed to characterize the clinical, neuropsychological, polysomnographic, and~     neuroimaging findings among subjects with Alzheimer's disease, Lewy Body dementia, and~     Parkinsons' Disease.~   "
41789|NCT03019744|"~     Goal of the present study is to evaluate the efficacy of Myoelectrically-controlled~     Functional Electrical Stimulation (MeCFES) for the rehabilitation of upper limb in~     post-stroke patients. MeCFES-assisted rehabilitation will be compared with usual care~     rehabilitation of upper limb. It is hypothesized that that applying MeCFES in rehabilitation~     to assist normal arm movements during rehabilitation of the upper limb in persons with stroke~     will improve the movement quality and success and thus induce recovery at the body functions~     level (impairment) and the activity level (disability) of the International Classification of~     Function (ICF) superior to that induced by usual care rehabilitation.~   "
41791|NCT03019718|"~     The purpose of this study is to implement the internet-based aftercare program 'GSA-Online~     plus' in several rehabilitation clinics with patients of different indications~     (psychosomatic, orthopedic and cardiovascular diseases). 'GSA-Online plus' is an~     internet-based aftercare program for patients with work-related problems or anxieties facing~     return to work after longterm sickness absence and inpatient rehabilitation. The patients~     have access to various exploratory and motivational videos on the study website until their~     inpatient rehabilitation ends. Afterwards, they start a 12-week writing intervention based on~     a psychotherapeutic concept, the psychodynamic 'Core Conflictual Relationship Theme Method~     (CCRT)'. Patients write weekly online diary entries which are answered by anonymous online~     therapists usually within 24 hours. In a previous randomised controlled trial the efficacy of~     the intervention was determined, whereas the current study focuses on the implementation and~     realization in a naturalistic setting (effectiveness).~   "
41792|NCT03019705|"~     The purpose of the current explorative study is to examine the effects of health-related~     internet use in individuals with pathological health anxiety using ambulatory assessment. In~     a naturalistic setting participants answer over a seven-day period questionnaires about their~     health-related internet use and its effects on affect, health anxiety and symptom severity in~     their usual daily lives.~   "
41793|NCT03019692|"~     Intraventricular hemorrhage (IVH) is the most commonly recognized cerebral lesion on~     ultrasound in extremely preterm infants. Papile classification is commonly used to grade the~     severity of IVH. Grade III-IV IVH and other lesions noted on ultrasound including~     periventricular leukomalacia (pvl) porencephaly, and ventriculomegaly are well Documented to~     be associated with adverse neurodevelopmental outcomes.~      However, the true impact of lower-grade IVH on the neurodevelopment of these extreme preterm~     infants has not been well described.~      Also Neurodevelopmental outcome for neonatal non-traumatic Intra Cranial Hemorrhage (ICH) is~     not well established.~      The aim of this study is to look retrospectively at babies with neonatal IVH or ICH and~     follow their radiological, cognitive, motor and functional outcomes.~      The study will focus on postnatal files, and on images performed as part of the child's~     follow-up during hospitalization and after discharge.~   "
41794|NCT03019679|"~     In this study the investigators aimed to investigate whether there is a relation between~     polycystic ovary syndrome and serum endocan levels.~   "
41795|NCT03019666|"~     This is a phase I trial with pilot expansion of HLA-haploidentical or HLA-mismatched related~     donor nicotinamide expanded-natural killer (NAM-NK) cell based therapy for patients with~     relapsed or refractory multiple myeloma (MM) or relapsed/refractory CD20-positive non-Hodgkin~     lymphoma (NHL). The primary endpoint of the study is to determine the maximum tolerated dose~     (MTD) of NAM-NK cells while maintaining safety.~   "
41796|NCT03019653|"~     The purpose of this study is to look at kidney function and hormonal function in patients~     with a history of heart failure and kidney dysfunction, and to see how the use of a new drug,~     ANX-042, affects those functions.~   "
41797|NCT03019640|"~     The goal of this clinical research study is to learn about the safety of giving immune cells~     called natural killer (NK) cells with chemotherapy and a stem cell transplant to patients~     with non-Hodgkin's lymphoma. Participants will receive an autologous stem cell transplant (a~     transplant of your own bone marrow or blood cells).~      Immune system cells (such as NK cells) are made by the body to attack foreign or cancerous~     cells. Researchers believe that the NK cells you receive from the donor may react against the~     non-Hodgkin's lymphoma cells in your body, which may help to control the disease.~      The NK cells will be separated from a donor's umbilical cord blood. These separated NK cells~     will then be grown in the lab to increase the number of NK cells that can be given to you by~     vein. If certain types of unwanted T cells are growing too much, an investigational device~     called a CliniMACS system will be used to filter out the unwanted T cells using a magnet.~      This is an investigational study. The way researchers process the NK cells is~     investigational. It is currently being used for research purposes only.~      The study drugs (carmustine, cytarabine, etoposide, lenalidomide, melphalan, and rituximab)~     are FDA approved and commercial available. Their use to prepare your body before an NK cell~     infusion is investigational.~      The study doctor can explain how the study therapy is designed to work.~      Up to 40 participants will be enrolled in this study. All will take part at MD Anderson.~   "
41798|NCT03019627|"~     The phase II study is a single-center, randomized, double-masked, parallel-arm,~     vehicle-controlled trial, designed to evaluate the safety and efficacy of Recombinant Human~     Nerve Growth Factor (rhNGF) eye drops at 20 μg/ml concentration administered six times daily~     for 8 weeks in patients with dry eye.~   "
41799|NCT03019614|"~     This was an open label, randomized, single dose, three period crossover pharmacokinetic study~     of Chronocort® in 30 healthy male volunteers. The study was conducted in smaller sub groups~     (Group 1, n=18 and Group 2, n=12).~   "
41800|NCT03019601|"~     A specific organized program utilizing peers in the PMTCT clinic who provide family planning~     information and support to HIV infected mothers was compared to providing standard family~     planning messages currently used in the clinic.~   "
41801|NCT03019588|"~     The study will compare the efficacy and safety of treatment with pembrolizumab (MK-3475)~     versus paclitaxel in Asian, programmed death-ligand 1 (PD-L1) positive participants with~     advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who have progressed after~     failure of any combination chemotherapy containing a platinum and a fluoropyrimidine agent.~      The primary study hypotheses are that pembrolizumab prolongs Overall Survival (OS) compared~     to paclitaxel and that pembrolizumab prolongs Progression-free Survival (PFS) per Response~     Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) assessed by blinded central~     radiologists' review compared to paclitaxel.~   "
41802|NCT03019575|"~     The purpose of the study is to investigate whether corifollitropin alfa (MK-8962),~     administered in combination with human chorionic gonadotropin (hCG), increases the testicular~     volume in adolescent males aged 14 to <18. In addition, the study will evaluate participants~     for the development of corifollitropin alfa antibodies over the course of 64 weeks of~     treatment.~   "
41803|NCT03019562|"~     Oxycodone is one of the most widely used opioids for pain treatment. Many studies~     demonstrated good efficacy of oxycodone on postoperative pain. In this study, we assess the~     efficacy and side effects of bolus intravenous of oxycodone injection compared to those of~     fentanyl in patients after total hip replacement surgery.~   "
41804|NCT03019549|"~     The purpose of this study is to evaluate the effect of lanabecestat on rosuvastatin. The~     amount of rosuvastatin in the blood will be compared, when taken alone, and then when taken~     with lanabecestat. The amount of lanabecestat that gets into the bloodstream will be~     measured. Information about any side effects that may occur will also be collected.~      Participants will be on study for 21 days with a follow-up at least 7 days afterwards.~      Screening will be undertaken within 45 days prior to enrollment.~   "
41805|NCT03019536|"~     The study involves repeated doses of LY3303560 given by injection for 25 weeks. The study~     will examine how safe repeated doses of LY3303560 are, whether they cause side effects in~     participants with mild cognitive impairment or Alzheimer's Disease, and how LY3303560 is~     handled by the body and acts in the body. This study will last up to 64 weeks, not including~     screening. Screening is required within 90 days prior to the start of the study.~   "
41806|NCT03019523|"~     This is a cross-over design study in which subjects arrived to the lab and were assigned a~     supplement to ingest. Prior to ingestion subjects completed baseline reaction time testing~     along with a questionnaire. Thirty minutes after ingestion subjects filled out the same~     questionnaire, completed a reaction time test, followed by a series of dynamic exercises.~     After the last exercise was finished subjects filled out the questionnaire, completed another~     reaction time test and repeated the series of dynamic exercises. Following the exercises,~     subjects filled out the questionnaire and completed a fourth round of reaction time testing.~     In total subjects would complete 2 rounds of dynamic exercises and 4 rounds of reaction time~     testing with heart rate being recorded before and after the dynamic exercise rounds. Subjects~     were told to wash-out for 7 days and return to the lab to complete the same testing but on~     the alternative supplement.~   "
41807|NCT03019510|"~     Morning hyperglycemia plays a role in the future development of insulin resistance and type 2~     diabetes (T2D) (8) and is associated with numerous microvascular and cardiovascular~     complications and renal disease. These augmented morning glucose levels are due to an~     elevated endogenous glucose production (EGP), as a result of a loss of coordination between~     glucose levels and insulin secretion, and possibly hyperglucagonemia during the overnight~     period. Exercise stimulates glucose uptake and increases insulin sensitivity acutely, and may~     be the best lifestyle intervention to minimize the nocturnal rise in glucose levels.~     Prescription of the timing of exercise relative to a meal and/or to the overnight period may~     be particularly critical for individuals that have impaired fasting glucose (IFG) levels.~     Surprisingly little is known about the overnight period when elevated EGP and the synchrony~     between glucose and c-peptide/glucagon levels becomes disturbed. This novel study will~     provide insight into the hormonal/metabolic milieu of a dinner meal, the evening and~     overnight period that occurs in non-obese, OB and OB+IFG individuals; it will also establish~     if the timing of exercise can attenuate nocturnal glucose elevations, and if this is~     associated with improved hormonal synchrony. This project will compare EGP, β-cell function~     and hormonal responses between morning and evening exercise on the postprandial and overnight~     period in obese individuals with/without IFG levels. Fifty-four subjects will be studied~     during the evening meal (EGP and β-cell function), postprandially and through the overnight~     period (1600-0700 h), allowing us to examine some of the potential mechanisms for the~     elevation in overnight glucose levels. This is the first study that will examine this issue~     from pre-dinner through the night while previous studies have only examined chronically~     fasted individuals and this study will lay the groundwork for understanding the pathology of~     the predawn phenomena in OB+IFG individuals. These potentially translational findings may~     impact the efficiency of physician communication to patients concerning exercise. These~     investigators are one of the few groups that study subjects through the overnight period and~     have the facilities and capability to do this research.~   "
41808|NCT03019497|"~     The purpose of this study is to evaluate the efficacy of a form of cognitive behavioral~     therapy (CBT) in a population of individuals with PTSD and common related problems~     (depression, anxiety or sleep disorders, pain, psychosocial stressors, low social support,~     substance use disorder). Half of the participants will receive a cognitive behavioral therapy~     with specific modules for the treatment of related problems (CBT-E) and the other half of~     participants will receive therapy without specific modules (CBT-C).~      The main assumption is that participants treated in the CBT-E condition will present a lower~     level of symptom intensity of PTSD and a higher remission rate than those in the CBT-C~     condition during the post-treatment assessment. As a secondary objective, an analysis of the~     different parameters of effectiveness of the two forms of CBT (e.g., average number of~     sessions required to reach remission, treatment strategies used) will be performed.~   "
41809|NCT03019484|"~     The aim of the study was to evaluate the effectiveness of a breastfeeding self-efficacy~     promotion intervention. More specifically our objectives were to: explore changes in~     self-efficacy following the intervention; explore changes in the initiation and maintenance~     of breastfeeding following the intervention.~   "
41810|NCT03019471|"~     The investigators aim to collect tumor DNA out of blood of cancer patients. If this is~     successful this could lead to the development of a cancer test in blood in the future, which~     is less invasive than current diagnostic methods.~   "
41811|NCT03019458|"~     To see whether MINGO, a food supplement, will be able to lessen the drastic weight loss seen~     among X-linked Dystonia Parkinsonism patients.~   "
41812|NCT03019432|"~     In this study, the researchers will investigate whether the E-effect is present in stroke~     subjects both on the subjective visual and postural vertical test. In addition, researchers~     will investigate the impact of the loss of different sensory information sources on the~     sensory reweighting strategies and perception of verticality by measuring the effect of~     somatosensory loss on the E-effect.~   "
41813|NCT03019419|"~     To investigate the safety and the efficacy of perampanel in patients with sporadic~     amyotrophic lateral sclerosis~   "
41814|NCT03019406|"~     Primary Objective:~      To evaluate the safety profile of neoGAA in patients with infantile-onset Pompe disease~     (IOPD) previously treated with alglucosidase alfa.~      Secondary Objective:~      To characterize the pharmacokinetic profile of neoGAA and to evaluate the preliminary~     efficacy of neoGAA in comparison to alglucosidase alfa.~   "
41815|NCT03019393|"~     This study aims to evaluate the effect of red meat intake on occurrence of non-transferrin~     bound iron (NTBI)~   "
41816|NCT03019380|"~     Wondertip is a silicone single use device with a coil end, designed for the purpose of~     evacuating impacted cerumen of external ear canals. This trial aims at testing the safety and~     efficacy of this device. The participating investigators will be ENT doctors with the skill~     of examining the treating ear problems.~   "
41817|NCT03019367|"~     This study is being done to find out whether umbilical cord milking (UCM) is at least as good~     as or better than delayed cord clamping (DCC) to reduce bleeding in the brain or prevent~     death in premature newborns. The investigators will study short and long term outcomes of~     infants delivered before 32 weeks gestation that receive either UCM or DCC.~   "
41818|NCT03019354|"~     In general anesthesia, gas exchange was altered by shunt and uneven ventilation perfusion~     ratios. Lung atelectasis was a cause of impaired oxygenation. High-flow nasal cannula oxygen~     therapy delivers adequately heated and humidified medical gas at up to 60 L/min of flow. It~     has physiological effects: reduction of anatomical dead space, positive end expiratory~     pressure (PEEP) effect, constant fraction of inspired oxygen, and good humidification. The~     hypothesis of this study is using high-flow nasal oxygen in intravenous general anesthesia~     could improve lung function and prevent lung atelectasis.~   "
41819|NCT03019341|"~     The prevalence of nausea and vomiting after the administration of non-ionic contrast media~     has rarely been assessed. Thus, the aim of our study is to evaluate the prevalence and risk~     factors of nausea and vomiting after the exposure to the non-ionic contrast media for~     computed tomography examinations in adults.~   "
41820|NCT03019328|"~     The recent finding that early introduction of peanut can prevent ~70-90% of peanut allergy is~     a major step towards prevention of food allergy. However, because that finding was from a~     clinical trial in a very select population, there are several major questions that must be~     answered in order to implement these findings into clinical practice without causing more~     harm than good. These questions include who, if anyone, should be screened prior to early~     introduction for peanut allergy, how this screening should be done, and what quantity of~     peanut ingestion is needed to prevent peanut allergy. The goal of this project is to answer~     these critical questions so that the potential of these recent findings can be realized. To~     that end, 400 infants at high-risk of peanut allergy will be enrolled. These infants will be~     given a peanut skin prick test, peanut food challenge and have blood drawn for measurement of~     peanut IgE, and then will be followed for assessment of peanut consumption and development of~     peanut allergy until 3 years of age.~   "
41821|NCT03019315|"~     Adjuvant chemotherapy was introduced in patients with early-stage ovarian cancer. The benefit~     of standard chemotherapeutic regimens including taxane has not been established. This study~     was conducted to investigate the influences of regimens of front-line chemotherapy on on~     recurrence and survival for early-stage ovarian adenocarcinoma. Further, the study will~     analyze cost-effectiveness of different regimens~   "
41822|NCT03019302|"~     A prospective study evaluating the timing, incidence and relationship of commonly occurring~     complications related to the use of peripherally-inserted central catheters. All subjects~     will receive PICC access using the Arrow PICC with Chloragard Technology.~   "
41823|NCT03019289|"~     The purpose of this study is to demonstrate engagement of pridopidine with S1R and D2R~     (optional) in the living human brain. No formal statistical analysis will be conducted~   "
41824|NCT03019276|"~     To study the pharmacokinetic characteristics of TQ-B3101 in the human body, recommend a~     reasonable regimen for subsequent research.~   "
41825|NCT03019263|"~     Menopause is usually associated with an increase in body weight, a change in body composition~     and fat distribution and a large number of cardio-metabolic changes, such as hypertension,~     reduction of insulin-sensitivity and dyslipidaemia. The first-line strategy for these~     complications is the modification of dietary habits and lifestyle in terms of physical~     activity. Besides, there is also a growing interest in complementary therapies (i.e.~     nutraceuticals) that can be used alone or in combination to achieve more consistent results.~     In this context, preliminary evidence supports the potential role of some compounds of~     vegetal origin such as berberine, chlorogenic acid and tocotrienols. However, in support of~     their use, the evidence from good quality trials is limited.~   "
41826|NCT03019250|"~     Enteral administration of immune-modulating nutrients such as glutamine, omega-3 fatty acids,~     selenium, and antioxidants has been suggested to reduce infections and improve recovery from~     critical illness. However, the effects of colostrum on clinical outcomes in critical ill~     patients has not been investigated. In current trial, intensive care unit patients with~     enteral feeding will receive either enteral colostrum or maltodextrin as placebo.~   "
41827|NCT03019237|"~     In this study, participants will receive either intranasal anti-IgE-antibodies (n=5) or~     intranasal allergen (n=5) or intranasal placebo (n=5). Blood samples will be obtained before~     nasal administration of study drugs and 3, 5 and 8 weeks thereafter. In the serum samples,~     specific and total IgE levels will be assessed.~   "
41828|NCT03019224|"~     Introduction: The pain sensitivity associated with whitening is the main problem reported by~     patients during dental whitening, and the use of desensitizing dentifrices is an alternative~     for the treatment of sensitivity.~      Objective: To evaluate clinically the influence of desensitizing dentifrices applied through~     a plastic tray, reducing the pain sensitivity and color variation caused by the technique of~     in-office dental whitening, through a controlled double-blind clinical study.~      Methods: A longitudinal prospective study was conducted with 48 individuals, 18 years and 30~     years of age, without gender distinction, who underwent in-office dental whitening using 35%~     hydrogen peroxide (Whiteness HP, FGM, Joinville , SC, Brazil) in three clinical sessions with~     a one-week interval between them. The volunteers used in the night for each bleaching session~     a plastic tray for 4 hours containing one of the dentifrices related to the experimental~     groups: Group 1 (Control) - Sucralose (S) (Biotype - Manipulation pharmacy); Group 2 (Active~     control) - Sodium fluoride (FS) with 1450ppm of fluorine (Close up triple, Unilever); Group 3~     - Arginine, calcium carbonate (ACC) and sodium monofluorophosphate with 1450 ppm fluorine~     (Colgate sensitive pro-relief, Colgate-Palmolive); Group 4 - 5% potassium nitrate (NP) and~     sodium fluoride with 1450 ppm fluorine (Sensodyne pro-enamel, GlaxoSmithKline). The~     evaluation of the sensitivity associated with the times of use of the plastic tray in the~     first session (S1: sensitivity before the tray, S2: sensitivity after the tray), in the~     second session (S3: sensitivity before the tray, S4: in the third session (S5: sensitivity~     before the tray, S6: sensitivity after the tray) used the analog numerical scale with scores~     from 0 to 10 and for the color evaluation the spectrophotometer (Easyshade, Vident, Brea, CA,~     Obtaining the data that were used in the CIELab system. The data were submitted to the~     multivariate analysis of variance (MANOVA) with repeated measurements and Lambda Wilks test~     with a 5% probability level to differentiate the groups. In addition, the factorial variance~     analysis (ANOVA) in one criterion was applied. Values of p <0.05 were considered~     statistically significant.~   "
41829|NCT03019211|"~     This is a pilot randomized control trial with single blinding of the assessor that will be~     conducted in two nursing homes residence to evaluate the applicability of a physical exercise~     program performed in an aquatic environment compared with the same realization but land-based~     to reduce falls in the institutionalized old people. The secondary objectives are to study~     the applicability of the intervention in improving balance, function, gait mobility, muscle~     strength of the lower limbs and the perception of the intervention.~   "
41830|NCT03019198|"~     This study aims to analyze the efficacy of intravenous tranexamic acid (TXA) in patients~     undergoing total hip arthroplasty (THA).~   "
44927|NCT02978768|"~     The objective of the present project is to develop complementary and alternative medicine~     (CAM) for The Chang Gung Dementia Center to alleviate the symptoms and signs of patients with~     Alzheimer Disease, an approach aiming at decreasing the burden on family, society and nation.~   "
41834|NCT03019146|"~     The incidence of conditions requiring surgical intervention increases with age, however there~     is a reported decline in the rates of elective surgical procedures in those over 65. This is~     associated with older patients being described as less fit and more at risk of~     postoperative complications, leading to decreased provision of surgical care to those at~     need. Exercise interventions have the potential to reverse some of the decline in~     cardiovascular fitness associated with aging and improve the elderly's' fitness for surgery~     and potentially allow increased access to surgical care for those most in need of it.~   "
41835|NCT03019133|"~     The goal of the project is to determine the effects of noise masking and noise reduction on~     stress related physiological parameters in critically ill patients admitted to the intensive~     care unit.~   "
41836|NCT03019120|"~     This study will evaluate the effect of vitamin D supplementation on the neurocognitive~     function of older people with lower than normal levels of vitamin D at baseline~   "
41837|NCT03019094|"~     Interventional, Prospective, Open Label study~   "
41838|NCT03019081|"~     The researchers propose to utilize a pharmacological approach involving infusions of the~     sympathomimetic agent isoproterenol to repeatedly trigger cardiorespiratory sensations and~     anxiety during meal anticipation, to facilitate the development of tolerance or a reduction~     of the anxiety/fear response in individuals with anorexia nervosa. The investigators aim to~     conduct a proof of principle study to assess for evidence of initial efficacy of this new~     treatment approach. As a comparator condition, the researchers propose using repeated~     administration of saline infusions.~   "
41839|NCT03019068|"~     This retrospective study aims to assess, on a large number of clinical trials (CT), the~     usefulness of converting CT eligibility criteria into standardized queries performed on~     commonly available data, i.e. Diagnosis Related Groups (DRG) databases in order to estimate~     the potential recruitment of clinical trials centers.~      Efficacy of this Clinical Trial Recruitment Support Systems (CTRSS) will be checked against~     thorough examination of patient files.~      Primary objective is to estimate the precision of the prediction system, i.e. ratio of~     numbers of eligible patient files / numbers of candidate patient files.~      As secondary objectives, the study aims:~        -  to measure the recall rate or sensitivity of the system: ratio of number of candidates~          patient files / number of recruited patients;~        -  to measure the ability of coding: proportion of codable criteria (inclusion criteria or~          non inclusion criteria) into normalized language;~        -  to measure the time required for coding criteria and the time required to execute the~          queries on the national DRG database;~        -  to evaluate the reliability of coding process by an independent coding of a random~          sample of 30 protocols;~        -  to analyse influence of characteristics of the clinical study (design, disease, ...) and~          of the investigation site (volume, teaching status, ...) on the precision and~          sensitivity of the prediction system.~   "
41840|NCT03019055|"~     This is a phase 1, interventional single arm, open label, treatment study designed to~     evaluate the safety and feasibility of infusion of autologous T cells engineered to contain~     an anti-CD19 and anti-CD20 scFv coupled to CD3ζ and 4-1BB signaling domains in patients with~     relapsed and/or refractory CD19 or CD20 positive B cell malignancies~   "
41841|NCT03019042|"~     This trial aims to determine whether Hou Gu Mi Xi is an effective treatment for improving~     symptoms and indicators in patients with spleen qi deficiency and mild gastrointestinal~     disorder.~   "
41842|NCT03019029|"~     The primary aim of this study will be to examine the diagnostic utility of 18-F Florbetapir~     PET/MR (Positron Emission Tomography/Magnetic Resonance) in imaging patients with~     pathologically-confirmed systemic amyloidosis involving the peripheral nerves and compare~     these results to non-amyloid diseased controls.~   "
41843|NCT03019016|"~     The primary objective of this study is to retrospectively compare the perioperative and~     short-term (discharge through 30 days) outcomes of intracorporeal and extracorporeal~     anastomosis in minimally invasive right colectomies for benign and malignant disease.~      The secondary objective of this study is to retrospectively compare the rates of incisional~     hernia (up to 6 month post procedure) between intracorporeal and extracorporeal arms.~   "
41844|NCT03019003|"~     This is a non-randomized, open-label, Phase Ib/II study to assess the safety and efficacy of~     azacitidine, durvalumab (MEDI4736), and tremelimumab combination therapy in the treatment of~     patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck~     (SCCHN) who have progressed during or after treatment with anti-PD-1, anti-PD-L1, or~     anti-CTLA-4 monotherapy for recurrent and/or metastatic disease. The clinical trial is~     studying drugs that can boost the participant's immune system against the cancer cells as a~     possible treatment for head and neck cancer.~      The study interventions involved in this study are:~        -  Azacitidine (Vidaza)~        -  Durvalumab (MEDI4736)~        -  Tremelimumab~   "
41845|NCT03018990|"~     To investigate the effects of acute alcohol challenge on the gut and liver axis.~   "
41846|NCT03018977|"~     Sedative and analgesic agents are widely used in the ICU. These agents can provide hypnotic~     effect, pain alleviation, cooperation, and synchronizing ventilatory support. Prolonged use~     of the agents can lead to withdrawal symptoms when the drugs are weaned.~      Prior study showed the longer duration of sedative drugs, cumulative dose of medications and~     younger age were the risk factors of withdrawal syndrome. Additional, some study showed the~     sedation protocol can reduce the incidence of withdrawal syndrome. However, no worldwide~     standardized sedative weaning protocol including our hospital. The objectives in this study~     are to establish the sedative weaning protocol and to compare the protocol sedative weaning~     with the usual care weaning.~   "
41847|NCT03018964|"~     The purpose of this study is to determine safety of solo surgery in single incision~     laparoscopic cholecystectomy (SILC) with a camera holder comparing to a camera operator~     assisted SILC~   "
41848|NCT03018951|"~     The purpose of this study is the development of, and two stages of pilot testing of, a tool~     designed to assess frailty in older adults with a diagnosis of a functional mental illness.~     During the tool's development stage, participants' input, ideas and feedback will be sought~     to inform the tool's design. In the first pilot test the comprehensibility, acceptability and~     feasibility of the tool will be established. The tool will be amended based on information~     gained in the first pilot test. In the second pilot test the comprehensibility, acceptability~     and feasibility of the revised tool will be established. Reliability of the tool will be~     explored and preliminary examinations of both the interpretability and construct validity of~     the tool will be completed.~   "
41852|NCT03018899|"~     This prospective, randomized study is aimed to assess the efficacy and safety of~     paravertebral block compared to epidural anesthesia for percutaneous nephrolithotomy. The~     investigators suppose that paravertebral block is not inferior in controlling the~     perioperative pain for percutaneous nephrolithotomy compared to epidural block.~   "
41853|NCT03018886|"~     The purpose of this study was to validate the growth hormone releasing hormone (GHRH) plus~     arginine (GHRH+arg) stimulation test and it´s cut-off limits for diagnosis of adult growth~     hormone deficiency using the growth hormone (GH) Immulite 2000 Xpi assay calibrated against~     the IS 98/574 from the World Health Organization. A specific aim was to study the effect of~     gender and age on the peak GH response in the GHRH+arg test~   "
41854|NCT03018873|"~     Patients with acute myocardial infarction (AMI) are in critical condition. When primary~     percutaneous coronary intervention (PCI) was performing, no-reflow, reperfusion injury，heart~     failure, heart rupture, malignant arrhythmia maybe happen. It was reported remote ischemic~     preconditioning (RIPC) may play an effective endogenous cardiac protection. This study will~     investigate whether once RIPC before primary PCI or long-term RIPC can improve AMI patients~     short-term and long-term (1 year) prognosis. 400 STEMI patients undergoing primary PCI were~     randomly divided into 3 groups: long-term RIPC group (once preoperative RIPC and once~     RIPC/day after PCI), preoperative RIPC group (once preoperative RIPC), control group (without~     RIPC). Cardiac troponin (TNI), high-sensitivity C-reactive protein (hsCRP), adenosine,~     vascular endothelial growth factor (VEGF), hypoxia inducible factor-1 (HIF-1),~     echocardiography and magnetic resonance （MR）were detected 1 day, 1 month and 1 year after~     PCI. Patients will be followed up by telephone at the end of one year. The major adverse~     cardiovascular events (MACE) include cardiovascular death, spontaneous myocardial infarction,~     unplanned revascularization and stroke.~   "
41855|NCT03018860|"~     Active phase of the second stage of labor corresponds to period of maternal expulsive efforts~     (i.e. pushing). An intensive management of this phase is usual in France. This study aims to~     evaluate the impact of an alternative moderate management during this pushing phase on~     neonatal and maternal issues and mode of delivery.~   "
41856|NCT03018847|"~     The purpose of undertaking this study is to examine the use of COPD Co-PilotTM, a COPD~     disease management program manufactured and operated by HGE Health Care Solutions, LLC, in~     COPD patients outside of the geographic base of HGE's existing patient population~     (Philadelphia, PA). The purpose is to demonstrate the feasibility of expanding the program to~     additional geographic sites and to examine whether similar outcome measures are achieved in~     patients under the supervision of health care providers that are new to the program.~   "
41857|NCT03018834|"~     There is no specific treatment of acute myocarditis, especially during the inflammatory~     period. Interleukin (IL) is specifically involved during this period and play a role in~     myocardial oedema. ANAKINRA, an IL-1β Blocker, is a new treatment that has never been~     evaluated in myocarditis. The benefit for the patient could be important with a reduction of~     heart failure and ventricular arrhythmias.~      Hypothesis : ANAKINRA in addition to standard therapy for treatment of Acute Myocarditis is~     superior to standard therapy based on an association of beta-blockers and~     Angiotensin-Converting-Enzyme inhibitor (ACE).~   "
41858|NCT03018821|"~     Although the incidence of Hepatitis B has been decreased a lot recently years, there are~     still quite a few chronic hepatitis B patients in China. The anti-virus drugs of western~     medicine such as Entecavir and Tenofovir have been proved effective on decreasing the serum~     hepatitis B virus (HBV) level, on the other hand, Chinese materia medica showed effective on~     TCM syndromes of chronic hepatitis B (CHB) such as hypochondriac pain, jaundice and abdominal~     mass. Besides, the hepatic fibrosis could be delayed after the appropriate treatment of TCM.~     This study is a multicenter, randomized, open label, parallel group clinical trial to~     evaluate the efficacy of two different traditional Chinese medicine (TCM) herbal treatment on~     chronic hepatitis B.~   "
41859|NCT03018808|"~     Early diagnosis and appropriate treatment for COPD patients are both critical to minimize the~     progression of COPD and improve outcomes. Also, evidence suggests that high eosinophil~     (specific type of white blood cell that protects body against certain kinds of germs) level~     is associated with increased risk of both moderate and severe exacerbations in COPD patients.~     To date, there is insufficient amount of data that describes the prevalence of COPD in~     Brazilian primary care units. Thus, this multicenter, cross-sectional study conducted in five~     centers located in five different Brazilian cities will provide estimation about the~     prevalence of COPD in primary care and will also determine the levels of eosinophils in~     subjects with confirmed COPD diagnosis. Approximately 2,500 eligible subjects are expected to~     be enrolled in the study.~   "
41860|NCT03018795|"~     Decontamination procedure is a challenging factor that affects the success of surgical~     regenerative therapy (SRT) of peri-implantitis. The purpose of the present study was to~     determine the impact of additional ozone therapy for the decontamination of implant surfaces~     in SRT of peri-implantitis. A total of 21 patients with moderate or advanced peri-implantitis~     were randomly allocated to the test group (ozone group) with the use of sterile saline with~     additional ozone therapy or the control group with sterile saline alone for decontamination~     of the implant surfaces in SRT of peri-implantitis. Clinical and radiographic outcomes were~     evaluated at baseline and 6 months postoperatively~   "
41861|NCT03018782|"~     The investigators are evaluating refugee torture survivors who are receiving services at the~     Weill Cornell Center for Human Rights. There are two research questions in this study: if the~     current standard of care results in the under or missed diagnosis of pain and pain syndromes,~     and if a validated pain screening tool can supplement the current standard protocol used in~     the assessments of survivors of torture.~   "
41862|NCT03018769|"~     1.1 To build a TCM diagnosis and treatment database for chronic stable CAD; 1.2 To summarize~     the pattern of TCM medicine used and the effect of the medication in chronic stable CAD.~      1.3 To formulate a syndrome differentiation determined medicine plan based on the improvement~     in the quality of life on chronic stable CAD patients.~   "
41903|NCT03018236|"~     This study evaluates the use of N-acetylcysteine in the treatment of alcohol and cocaine use~     disorders. Alcohol users will be split in two groups, one will receive the active~     N-acetylcysteine and the other placebo. The same division will occur with cocaine users. The~     effects of N-acetylcysteine in adherence, abstinence, psychiatric symptoms and stress~     biomarkers will be evaluated.~   "
41863|NCT03018756|"~     Patients with idiopathic pulmonary fibrosis (IPF) experience distressing activity-related~     respiratory discomfort which is challenging to manage therapeutically. Interventions such as~     pulmonary rehabilitation, collaborative self-management, supplemental oxygen therapy and oral~     opiate medications, are variably effective and therapeutic responses to each in individual~     patients are difficult to predict. The purpose of this study is to evaluate the acute effects~     of inhaled opiate therapy (fentanyl citrate) on breathing discomfort (dyspnea) in individuals~     with mild-to-moderate IPF, as well as examine the potential mechanisms of dyspnea relief.~   "
41864|NCT03018743|"~     Premature ejaculation (PE) has been known as one of the most common male sexual dysfunction.~      Until now dapoxetine is the only approved medical treatment option and there is no second~     line therapy in case of no-response or refuse to dapoxetine, a comprehensive evaluation of~     the factors that lead to dropout is needed especially in a real-practice setting.~      With this background, investigators are going to assesse the discontinuation rate of~     dapoxetine treatment in patients with PE and the reasons for discontinuation in a clinical~     setting throughout a follow-up period of 2 years.~   "
41865|NCT03018730|"~     This is an open label switch over study to assess the safety and efficacy of PRX-102~     (pegunigalsidase alfa). Patients treated with agalsidase alfa for at least 2 years and on a~     stable dose (>80% labelled dose/kg) for at least 6 months. Patients will be screened and~     evaluated over 3 months while continuing on agalsidase alfa. Following the screening period,~     the patient will be enrolled and switched from their agalsidase alfa treatment to receive~     intravenous (IV) infusions of PRX-102 1 mg/kg every two weeks for 12 months. No more than 25%~     of treated patients will be female.~   "
41866|NCT03018717|"~     Information and communications technologies (ICT) currently constitute a key element in the~     innovation and improvement of providing health-care to frail populations with advanced~     chronic diseases, but it´s efficacy, safety and cost-effectiveness has not yet been proven~     conclusively. The investigators are going to carry out a multi-center, randomized, parallel~     groups, phase III clinical trial in adult patient with heart and/or lung advanced~     diseases,aiming to analyze the efficacy and cost-efficacy of tele-monitorization of~     bio-parameters added to optimal standard of clinical care (shared clinical care plan)~     compared to the shared clinical care plan exclusively.~   "
41867|NCT03018704|"~     The focus of this application is on the improvement of services for African American (AAs)~     Veterans afflicted with an alcohol use disorder. The project focuses on the use of topiramate~     as a treatment for alcohol use disorders. Despite having lower rates of heavy drinking than~     European Americans (EAs), AAs have significantly higher rates of mortality from a variety of~     alcohol-related conditions, including liver cirrhosis, accidents, and violence. Despite the~     higher rates of morbidity and mortality, pharmacological treatments are understudied in this~     population and there is some evidence that medications are less preferred and less effective~     in AAs.~   "
41868|NCT03018691|"~     To evaluate the safety, efficacy (dose response) and pharmacokinetics of 0.3% and 1%~     OPA-15406 when applied twice daily for 4 weeks in pediatric patients with atopic dermatitis.~   "
41869|NCT03018678|"~     Homozygous Familial Hypercholesterolemia (HoFH) is a rare genetic metabolic disorder~     characterized by markedly elevated LDL-cholesterol (LDL-C) levels, resulting in severe~     atherosclerosis often leading to early onset of cardiovascular disease. The most frequent~     cause is mutation in the LDL receptor gene (LDLR). LDL-C levels remain frequently above~     acceptable levels despite treatment with multiple existing lipid lowering drugs and/or LDL~     apheresis. Thus, the functional replacement of the defective LDLR via AAV-based~     liver-directed gene therapy may be a viable approach to treat this disease and improve~     response to current lipid-lowering treatments. The purpose of this protocol is to identify~     and screen potential candidates for future enrollment in a gene therapy clinical trial. No~     study drug will be administered in this screening study.~   "
41870|NCT03018665|"~     The purpose of this study is to determine the effect of GLP-1 receptor agonist on inducing~     diabetes remission in newly diagnosed type 2 diabetes who are overweight or obese~   "
41871|NCT03018652|"~     Chronic obstructive pulmonary disease (COPD) is a progressive inflammatory disease of the~     airways, associated with poor health status, functional disability, significant morbidity,~     and increased risk of death. In Ontario, COPD is the leading cause of hospital admission and~     readmission, and costs the health system approximately 3 billion dollars annually.~     Individuals with COPD experience increased 'flare-up's' (acute exacerbations) as their~     disease worsens, characterized by periods of increased shortness of breath, cough, phlegm~     production, and weakness. Acute exacerbations of COPD (AECOPD) are most commonly caused by~     viral or bacterial infections, and often require patients to seek attention at the emergency~     room or hospital for treatment. Current treatments to prevent COPD exacerbations are only~     modestly effective. New therapies are needed to improve the quality of life and clinical~     outcomes for individuals living with COPD.~      Previous research at our center has shown a favourable effect of an antibody treatment~     (immunoglobulin) on the frequency of AECOPD, doctor visits, treatments, and hospitalizations~     for COPD patients. However, rigorous studies with more patients are required to confirm this~     effect.~      The investigators propose a clinical trial to evaluate immunoglobulin treatment in~     outpatients with frequent exacerbations. In this study the investigators will determine if~     immunoglobulin treatment is feasible, safe, tolerable, and potentially effective in reducing~     the frequency of acute exacerbations. If this study is feasible and potentially effective, it~     will inform larger studies to confirm the therapeutic effect of immunoglobulin treatment, and~     would be a major advance in care of COPD.~   "
41872|NCT03018639|"~     Participants with Borderline pathology (≥ 3 DSM-IV-criteria) receiving an inpatient~     Dialectical Behavior Therapy (DBT) program completed a quality assurance questionnaire set~     assessing demographic information and pretreatment psychopathology during the days of their~     inpatient stay. Beyond that, changes of therapists were documented.~   "
41873|NCT03018626|"~     This is a randomized, open-label, multi-center, phase 3 study evaluating the efficacy of~     R-ACVBP and DA-EPOCH-R in patients with newly diagnosed non-germinal b-cell-like diffuse~     large B-cell lymphoma~   "
41945|NCT03017677|"~     In this study the investigators is aimed to establish the MPS screening algorithm for high~     risk patients who had medical history of previous surgical repair or presence of inguinal~     and/or umbilical hernia with combination of any ENT related surgery or examination in Taiwan.~   "
41874|NCT03018613|"~     Chronic functional constipation is a common digestive system disease, the incidence is~     increasing in recent years.It is reported that the occurrence and development of chronic~     functional constipation is closely related to imbalance of intestinal flora .Moreover,types~     and quantity of intestinal flora may be related to intestinal motility. Fecal microbiota~     transplantation as a new technology to rebuild intestinal flora has been used for several~     disease，but the clinical efficacy of chronic functional constipation by fecal microbiota~     transplantation needs to be further explored.~   "
41875|NCT03018600|"~     Glucocorticoid is widely used in clinical treatment. Recently, there was research about~     glucose fluctuations under low-dose and pulse steroid therapy in elderly patients with active~     autoimmune diseases. Through this prospective trial, the investigators wanted to know the~     blood glucose characteristics under high dosage glucocorticoid (1-2 mg/kg/day prednisone or~     equivalent) in young patients (30-40 years) with active autoimmune diseases with or without~     low-dose glucocorticoid maintenance. The investigators used continuous glucose monitoring for~     72 hours to get a better understanding of the glucose levels.~   "
41876|NCT03018587|"~     A single-center, prospective, open-label feasibility study of the truSculpt radiofrequency~     device.~   "
41877|NCT03018574|"~     Source: Sample bank of Xijing Hospital and Children's Hospital Affiliated to Soochow~     University; Sample form: Whole blood; Estimated number of samples: 100 patients with ADHD and~     age, sex matched healthy controls; Case exclusion criteria: all kinds of neuropsychiatric~     disorders, IQ value of less than 70;~      Study protocol:~        1. Using Qiagen kit to extract the genomic DNA of 200 microliters of blood.~        2. UV spectrophotometer test DNA purity of 260/280 close to 1.8 (1.8 ± 0.05), the~          concentration of 100ng/μL or more before the next sequencing.~        3. The extracted genomic DNA will be sent to Sangon Biology Engineering Limited Company~          (Shanghai) and sequenced to find candidate mutations related to ADHD risk sequence.~          According to NIH gene database, the longest transcript of NDRG2 (ID: 57447 gene,~          https://www.ncbi.nlm.nih.gov/nuccore/NC_000014.9?~          Report=genbank&from=21016763&to=21070872&strand=true) (a total of 17 exons and 16~          introns and the gene 5 'UTR and 3' UTR region) will be alignmented sequences to find~          potential mutations.~        4. Using the chi square analysis and other statistical methods to determine the~          relationship between the mutations and susceptibility to ADHD.~   "
41878|NCT03018561|"~     People with cardiovascular risk (CV) factors (obesity, diabetes, etc...) or established heart~     disease (such as coronary heart disease or chronic heart failure) often have cognitive~     dysfunction as compared to people without CV risk factors or heart disease. Among the~     mechanisms, a reduced cardiac output and cerebral blood flow in those people have been~     suggested. The aim of this study was to compare resting cognitive function, maximal~     cardiopulmonary function, cardiac output and cerebral hemodynamics during exercise in~     patients with metabolic syndrome, coronary heart disease, or heart failure vs. healthy~     subjects.~   "
41879|NCT03018548|"~     To monitor changes in indicators of red cell damage such as extracellular hemoglobin,~     potassium (K-ABL), and lactate dehydrogenase (LD) post blast exposure.~   "
41880|NCT03018535|"~     Idiopathic Membranous nephropathy (IMN) is an auto-immune glomerular disease. Recent studies~     suggest that circulating auto-antibodies against the podocyte surface antigens phospholipase~     A2 receptor1 (PLA2R1) and thrombospondin type 1 domain-containing 7A (THSD7A) cause the~     disease in the majority of the patients. Additional autoantibodies, directed to podocyte~     neo-expressed cytoplasm proteins have been described, including aldose reductase (AR),~     Mn-superoxide dismutase (SOD2) and alpha-enolase (alpha-ENO).~      The commonest presentation of IMN is nephrotic syndrome. Data from placebo arms of~     interventional studies show that 30-40% of the untreated patients with persistent nephrotic~     syndrome (NS) progress to end-stage renal disease (ESRD).~      The best-validated treatment regimen of IMN is combination therapy with steroids and~     cyclophosphamide, capable to induce remission of protenuria in two-third of the patients.~      Despite this evidence of efficacy, there are concerns about the use of cyclophosphamide,~     since it may be associated with adverse events, including bone marrow suppression, gonadal~     toxicity, infections and oncogenic effects. Thus, the availability of alternative therapies~     highly effective but with a greater safety profile is desirable.~      Given the key role of IgG antibodies in IMN, B cell depletion may favourably impact the~     glomerular disease. The anti-CD20 monoclonal antibody Rituximab is a selective B cell~     depleting agent. There is evidence that Rituximab is effective in the treatment of other~     diseases in which B cells play a key role, such as ANCA-related vasculitis. Observational~     studies in IMN provided encouraging data; in addition, the drug seems well tolerated.~      Head-to-head comparisons between Rituximab and steroid plus ciclophosphamide in randomized~     clinical trials are missing.~      The investigators propose this study in order to test, in a randomized controlled trial, the~     hypothesis that Rituximab is more effective than cyclical steroid/alkylating-agent therapy in~     inducing remission in patients with IMN and NS undergoing the initial treatment. In addition,~     the levels of the above-mentioned pathogenetic autoantibodies will be measured at baseline~     and during treatment. Finally, the study will compare the safety profile of steroid plus~     cyclophosphamide and Rituximab by evaluating the rate and severity of adverse events~   "
41881|NCT03018522|"~     Primary aim of this study is to evaluate the association between postoperative cognitive~     dysfunction and increased serum levels of S100B protein after robot-assisted laparoscopic~     radical prostatectomy.~   "
41882|NCT03018509|"~     Study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effect of~     JTE-451 administered for 4 weeks in subjects with active plaque psoriasis.~   "
41883|NCT03018496|"~     This study intends to examine the effect of a commercially available nutritional supplement,~     Beta-hydroxy-beta-methylbutyrate(HMB) on whole-body responses to a sugar load.~   "
41884|NCT03018483|"~     The aim of this multicenter, randomized controlled trial is to evaluate the weaning time from~     mechanical ventilation comparing non-variable PSV, variable PSV, and Smart CareTM.~      This study is a multicenter randomized controlled open trial comparing variable, non-variable~     pressure support ventilation and Smart CareTM in patients receiving mechanical ventilation~     for more than 24 hours who are able to be weaned.~      The aim of the study is to determine the duration of weaning from mechanical ventilation for~     each one of the above mentioned weaning methods~   "
41885|NCT03018470|"~     Acute exacerbation of COPD (AECOPD) worsen prognosis and quality of life of COPD patients.~     Telemonitoring could be a useful tool for early identification of AECOPD. Parameters that~     have to be monitored are not well defined.~      Patients with severe COPD may use home non-invasive ventilation (NIV). NIV have built-in~     software which are recording the breathing pattern of patients when used. The aim of this~     study is to identify ventilation parameters that are modified at the early stage of an~     AECOPD.~   "
41946|NCT03017664|"~     This quality improvement project will include a practice change based on national guidelines~     for the nutritional management of PICU patients.~   "
41947|NCT03017651|"~     This protocol will determine the pK profile of two different omega-3 fatty acid supplements~     on plasma EPA and DHA levels.~   "
41886|NCT03018457|"~     Dental implants are a prosthetic rehabilitation device whose success depends of the bone~     morphology and quality, in more the surgical procedure.~      This study aims to assess whether the parameters of the trabecular microarchitecture of~     alveolar bone taken from the site of the placement of the dental implant, calculated by~     micro-CT are correlated with ISQ (implant stability quotient) using the Osstell according the~     principle of the resonance frequency analysis at the 10th postoperative week during the~     osseointegration of dental implants (secondary stability).~      The cortical alveolar bone is a recognized factor in the phase of primary stability of~     osseointegration. The role of trabecular bone in the secondary stability is not clearly~     determined.~   "
41887|NCT03018444|"~     The primary objective of the present study is to evaluate the effect of HMG-CoA reductase~     inhibition during 14 days on the postprandial plasma GLP-1 response in healthy individuals.~     Secondary objectives include the evaluation of HMG-CoA reductase inhibition on postprandial~     glucose tolerance, gallbladder emptying, gastric emptying, plasma responses of lipids, bile~     acids and pancreatic and enteric hormones known to influence glucose metabolism and appetite,~     and faecal content of bile acids and gut microbiota composition.~   "
41888|NCT03018431|"~     We aim to show that systematic ultrasonography performed in ventilated patients suspected of~     ventilation-acquired pneumonia could improve the accuracy of diagnostic of pneumonia, and~     helps defining the diagnostic of tracheobronchitis when lower respiratory tract infection is~     considered.~      Chest CT scan is often performed before or just after admission in ICU, and usually show~     abnormalities that are revealed later on standard radiographs.~      This last exam is traditionally considered as the gold standard to prove new pulmonary~     infiltrates, but the correlation with parenchymal consolidation is pretty low, and lead to~     over-diagnosing pneumonia, thus leading to a massive and maybe sometimes unconsidered~     prescription of antibiotic therapy.~      Lung ultrasonography conducted systematically within the 3 first days after suspcion of~     pneumonia could help making the difference between real infection-linked lesions, and banal~     abnormalities following the hydric inflation of intra-thoracic organs, for instance pulmonary~     edema or pleural effusion.~      An independent evaluation using lung ultrasound, and analysis of CT scan acquisition when~     performed, compared with the physician in charge of the patient appreciation by suggesting~     him to provide his own probability of pneumonia upon routine clinical and biological datas.~   "
41889|NCT03018418|"~     The purpose of this research study is to determine whether the amount of radiation given to~     the normal areas around the anal cancer can be reduced by using Proton Therapy while reducing~     the side effects that are seen with standard therapy.~   "
41890|NCT03018405|"~     THINK (THerapeutic Immunotherapy with NKR-2) is a multinational (EU/US) open-label Phase I~     study to assess the safety and clinical activity of multiple administrations of autologous~     NKR-2 cells in seven refractory cancers, including five solid tumors (colorectal, ovarian,~     bladder, triple-negative breast and pancreatic cancers) and two hematological tumors (acute~     myeloid leukemia and multiple myeloma).~      The trial will test three dose levels. At each dose, the patients will receive three~     successive administrations, two weeks apart, NKR-2 cells. The dose escalation part of the~     study will enroll up to 24 patients while the extension phase would enroll 86 additional~     patients.~   "
41891|NCT03018392|"~     The purpose of this study is to evaluate the fusion rate and clinical outcomes at 1 year of~     20 patients with degenerative disc disease who undergo a Transforaminal Lumbar Interbody~     Fusion (TLIF) with the Stryker Tritanium Spinal System. This is an on-label, post-market~     outcomes study to build on the body of long-term evidence for the device.~   "
41892|NCT03018379|"~     Considering the increasing public health concern the obesity in Morocco, the aim of the~     present study was to use isotope techniques to assess body fat, total energy expenditure and~     physical activity to inform design and improve interventions for the prevention and control~     of obesity and related health risks such as diabetes and elevated blood pressure among~     children and adolescents. Specific objectives of the trial: 1. Determine the extent of~     obesity and physical activity levels in children and adolescents to design effective~     interventions in the school setting. 2.Propose alternative field based techniques for~     assessing body composition and physical activity that could be used in largescale situation~     assessments and in assessing interventions to address obesity and risk related health care. *~     For body composition: BMI z-score, waist circumference, waist measurement at height. * For~     physical activity: Questionnaire, Accelerometers 3. To identify factors contributing to the~     development of obesity and related health risks in schoolchildren and adolescents. 4.~     Collaborate with stakeholders (government, schools and / or colleges, communities and~     development partners) in designing interventions to address obesity and health risks. 5. To~     recommend to stakeholders the most effective interventions in schools to prevent and combat~     obesity and health risks in children and adolescents.~   "
41893|NCT03018366|"~     The purpose of this study is to determine whether low estrogen levels in young women with~     hypothalamic amenorrhea (premenopausal HypoE) is associated with risk factors for~     cardiovascular disease.~      For this study, the investigators will measuring vascular function and immune markers on:~        -  young women with hypothalamic amenorrhea (>3 months of no menstrual cycle due to low~          estrogen)~        -  young women with regular menstrual cycles not on hormone therapy.~        -  recently menopausal women (<3 years from final menstrual period) not on hormone therapy.~      Premenopausal HypoE participants will then be randomized to use either an estrogen patch or a~     placebo patch (no active medicine) for 3 months, followed by estrogen or placebo patch plus~     progesterone or placebo pills for 2 additional weeks. The investigators are looking to see if~     estrogen improves vascular and immune function.~   "
41894|NCT03018353|"~     Curing HCV in Incarcerated Patients (CHIP) is a 1-year demonstration project that will assess~     the feasibility of a HCV treatment program in the San Francisco City & County Jail. The Jail~     Health Services will treat 100 patients using the FDA approved combination treatment,~     sofosbuvir/velpatasvir, Epclusa® and will continue their treatment during incarceration and~     after their release (if applicable).~   "
41895|NCT03018340|"~     To assess the efficacy of pimavanserin compared to placebo when given adjunctively to a~     selective serotonin reuptake inhibitor (SSRI)/serotonin-norepinephrine reuptake inhibitor~     (SNRI) antidepressant as treatment of patients with Major Depressive Disorder (MDD) and an~     inadequate response to antidepressant therapy~   "
41896|NCT03018327|"~     Transplant-related malignancies have emerged as one of the important complications after~     organ transplantation. Some studies have shown that transplant recipients have an increased~     risk of developing cancer, especially non-melanoma skin cancer. Because of iatrogenic~     immunosuppression in these patients, there is an increasing focus on human papillomavirus~     (HPV) related cancers.~      The occurrence of HPV infection and ano-genital precancerous lesions and genital warts among~     Danish renal transplant recipients (RTRs) is not known. Relatively few controlled studies~     exist on the prevalence of ano-genital HPV infection, anal precancerous lesions and cervical~     precancerous lesions among RTRs.~      Knowledge about HPV infection and HPV-related ano-genital precancerous lesions in renal~     transplant recipients, together with identification of factors that play a role for~     development of anal and cervical precancerous lesions, is important for the possibility of~     early detection and treatment to prevent progression to ano-genital cancers. Cervical~     cytology has been used for decades to detect cervical intra-epithelial neoplasia (CIN),~     whereas high-resolution anoscopy is a newer modality for the detection of anal~     intra-epithelial neoplasia (AIN). International guidelines recommend annually screening~     against cervical cancer for female renal transplant recipients, but currently no~     recommendation exists on screening against anal cancer.~      Aim: In a clinical study it is the aim to examine the prevalence of anal, penile, oral and~     cervical HPV infection as well as ano-genital dysplasia and ano-genital warts among 250 renal~     transplant recipients and an immunocompetent control group. Furthermore to identify factors~     associated with the development of AIN or CIN such as HPV type, viral load, duration of~     immunosuppression, and lifestyle factors such as sexual habits, reproductive history, smoking~     and alcohol habits, history of genital warts and other infections, and socio-economic~     variables.~   "
41897|NCT03018314|"~     The study population is comprise of 90 women those age varies between 18-38 year-old. The~     first group will comprise of 30 women with polycystic ovaries or anovulatory cycles, the~     second group will comprise of 30 women with diagnosis of unexplained infertility and the~     third group will comprise of 30 women those partners with male subfertility. A 2 cc blood~     sample for Kisspeptin analysis will be drawn from the antecubital vein from each~     participants. The patients will receive 50 mg clomiphene citrate at the fifth day of the~     menstrual period and follicular development will be measured with serial ultrasound follow~     up.~   "
41898|NCT03018301|"~     The purpose of this study is to investigate the analgesic effect of low-dose intravenous~     ketamine in pregnant mothers undergoing cesarean section under Bupivacaine spinal anesthesia.~   "
41899|NCT03018288|"~     Background:~      GBM refers to a specific kind of brain cancer called glioblastoma. The standard treatment for~     GBM is radiation plus temozolomide, an oral chemotherapy drug. Pembrolizumab is an immune~     therapy that is now used to treat other cancers. The addition of pembrolizumab to the~     standard treatment of radiation and temozolomide has been shown to be well tolerated.~     Researchers want to see if adding a vaccine made from the person s own tumor will improve the~     effect of the pembrolizumab. The vaccine which is developed from fresh tumor taken at the~     time of surgery is called HSPPC-96.~      Objectives:~      To see if the adding pembrolizumab and HSPPC-96 improves the standard treatment for~     glioblastoma multiforme.~      Eligibility:~      Adults at least 18 years old with glioblastoma.~      Design:~      Participants will be screened with typical cancer tests:~      Brain scan~      Medical history~      Blood and urine tests~      Questions about quality of life and symptoms~      These tests will be repeated throughout the study.~      Participants will have surgery to remove their tumor. A tissue sample from the tumor will be~     sent to a lab. A vaccine will be made from it.~      Some participants will get pembrolizumab and vaccine. Some will get pembrolizumab and~     placebo. Participants will not know which they get.~      Participants will get radiation for 6 weeks.~      Participants will take temozolomide by mouth before each treatment.~      Participants will get pembrolizumab by IV for 30 minutes 3 times over the radiation cycle.~      Participants will keep taking the 2 drugs every few weeks for about a year. Some may take~     pembrolizumab for an additional year.~      Most participants will get the vaccine or placebo after radiation. They will get it 5 times~     over 6 weeks. Some participants will continue to get the vaccine every few weeks for 1 or 2~     years.~      Participants will repeat the screening tests when they stop study treatment. They will also~     have follow-up phone calls.~   "
41900|NCT03018275|"~     Background:~      Atopic dermatitis (AD) is a skin disease also called eczema. It is common in children and~     sometimes gets better on its own. However, chronic AD may cause asthma, food allergies, eye~     infections, and sleep problems. The cause of AD might be related to bacteria that live on the~     skin. Researchers want to see if introducing bacteria, R mucosa, from healthy skin onto the~     skin of someone with AD helps treat the disease.~      Objective:~      To test the safety and activity of R mucosa for treating AD.~      Eligibility:~      Part 1: People ages 18 and older with AD~      Part 2: Children ages 3-17 with AD~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Examination of their AD~      Blood and urine tests~      At the baseline visit, participants will have blood tests and photos taken of their skin.~     They will get a supply of R mucosa and a memory aid to track their doses and record how they~     are feeling. Part 2 participants guardians will complete questionnaires about their child s~     AD.~      Part 1 participants will spray R mucosa on their arm twice per week for 6 weeks.~      Part 2 guardians will spray it on their child s arm twice per week for 16 weeks.~      Participants will have follow-up visits to repeat some baseline tests and review their memory~     aid:~      Part 1: Six weeks after the baseline visit~      Part 2: Four times over 16 weeks; then 2 or 3 times for 1 year~      Participants will be called or emailed to discuss how they are feeling:~      Part 1: About 30 days after their last visit~      Part 2: About every 10 days between visits~   "
41901|NCT03018262|"~     Background:~      Movement disorders have many different causes and symptoms. Researchers still do not fully~     understand which parts of the brain are involved in fine movement. They want to learn about~     which brain regions could be abnormal in people with movement disorders.~      Objective:~      To better understand how the brain controls movement.~      Eligibility:~      Healthy, right-handed adults age 18-70 years old.~      Design:~      Participants will be screened with a physical exam and questions about their handedness. They~     may have a urine test.~      Participants will have 1 or 2 clinic visits. The first visit will last about 1.5 hours. The~     second will last about 3 hours.~      Participants will have structural magnetic resonance imaging (MRI). A strong magnetic field~     and radio waves take pictures of the brain. Participants will lie on a table that slides in~     and out of a metal cylinder.~      Participants may have transcranial magnetic stimulation. A wire coil is held on the scalp. A~     brief electrical current is passed through the coil and creates a magnetic pulse that~     stimulates the brain. Participants will wear a pair of glasses or a headband with small~     sensors so researchers can track head position.~      Participants will perform a simple index finger movement task.~      Participants may have surface electromyography from at least two hand muscles. Small metal~     disk or adhesive pad electrodes will be taped to the skin. Participants will be seated in a~     comfortable chair with their hands placed on a pillow.~      Participants may have an electroencephalography. A cap with small disc electrodes will be~     placed on the scalp.~   "
41902|NCT03018249|"~     This randomized phase II trial studies how well medroxyprogesterone acetate with or without~     entinostat before surgery works in treating patients with endometrioid endometrial cancer.~     Medroxyprogesterone acetate is a progesterone, a hormone produced by body normally.~     Entinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Given medroxyprogesterone acetate with or without entinostat may work better in~     treating patients with endometrioid endometrial cancer.~   "
42589|NCT03009292|"~     Study E7080-C086-108 is an open-label, single- and multiple-dose pharmacokinetic (PK) study~     of lenvatinib (administered orally, once a day [QD]) in Chinese participants with solid~     tumor. A total of 12 participants will be enrolled to evaluate the PK of 24 milligrams (mg)~     QD dosing of lenvatinib.~   "
41904|NCT03018223|"~     The purpose of this study is to find out if a combination of drugs (these are called:~     cyclophosphamide, sirolimus, and mycophenolate mofetil) will protect participants better~     against graft vs. host disease (GVHD) after receiving a hematopoietic cell transplant from a~     related partially matched (haploidentical) donor. As part of the treatment for their blood~     cancer, participants need a hematopoietic cell transplantation (HCT) to improve their chances~     of cure. In any HCT, after the stem cell infusion is given, a combination of drugs is needed~     to prevent GVHD and facilitate acceptance of the graft.~   "
41905|NCT03018210|"~     The proposed study will be a multi-centre, prospective, observational cohort to determine if~     psychological well-being has an impact on the outcome of surgical repair for rotator cuff~     tears.~   "
41906|NCT03018197|"~     The purpose of this pilot study is to examine the use of a personal health record to improve~     medication adherence among patients with non-valvular atrial fibrillation taking dabigatran~     for primary prevention of embolic stroke.~   "
41907|NCT03018184|"~     Patients with inherited muscle diseases can have several problems in their muscles, which can~     be both structural and metabolic. All the different diseases can affect the contractility of~     the muscles. The aim of the study is to investigate the relation between muscle strength and~     contractile cross sectional area (CCSA) in the thigh and calf in patients affected by~     inherited muscle diseases.~   "
41908|NCT03018171|"~     The study aims to evaluate the impact of the addition of 20 mcg of intrathecal clonidine in~     combined spinalepidural for labor analgesia on the local anesthetic consumption, on labor~     performance and on maternal fetal well-being.~   "
41909|NCT03018158|"~     The objective of this study was to compare level of artifact while tongue at rest and in~     motion of dentulous subjects.~   "
41910|NCT03018145|"~     To evaluate the effect of wagon for transporting vehicle instead of standard stretcher car~     for reducing preoperative children's anxiety.~   "
41911|NCT03018132|"~     This study is designed to comprehensively investigate the anti-inflammatory role of vitamin D~     in reproductive aged women, and its association with preeclampsia and depression. Findings~     will have substantial impact providing new information implicated in the development of~     preeclampsia (a condition that may include hypertension, tissue swelling caused by excessive~     fluid, and kidney stress) and postpartum depression (after birth).~      Additionally, the study is designed to understand how early mental health screening and~     evaluation can help pregnant women reduce their risk of developing postpartum depression.~     Testing the acceptability and effectiveness of this mental health screening, education and~     referral program at Cedars-Sinai Medical Center will provide valuable patient centered~     qualitative and quantitative data that can be used in future services planning.~      The study will enroll up to 200 pregnant women (in third trimester of pregnancy) in total.~   "
41912|NCT03018119|"~     The National Partnership for Maternal Safety (NPMS) developed an obstetric hemorrhage~     consensus bundle to provide every United States birthing facility consistent, validated~     practice guidelines. To facilitate implementation of each element of this bundle at the~     participants large tertiary center, the investigators utilized the Delphi method to identify~     deficiencies, perceived barriers to implementation, and multidisciplinary consensus on~     changes with high feasibility and impact on patient care.~   "
41913|NCT03018106|"~     Vulvovaginal atrophy (VVA) is a condition that impacts up to 60% of the growing~     postmenopausal female population, and the most common symptom is dyspareunia. Vaginal~     estrogen is the most common treatment for VVA, but it only marginally improves overall sexual~     function, and many women and clinicians avoid using it because of the risks of exogenous~     estrogen use during menopause. Ospemifene is a non-estrogen selective estrogen receptor~     modulator (SERM) that is FDA-approved for treating dyspareunia related to VVA, and has shown~     superb improvements in overall sexual health. 104 women will be randomized to receive 12~     weeks of 60mg oral ospemifene, taken daily, or 12 weeks of 0.5mg vaginal conjugated~     estrogens, which is placed vaginally twice per week. The improvements in sexual health and~     VVA symptom severity will be compared in each group. This study will help determine if~     ospemifene is a better treatment medication than conjugated estrogens.~   "
41914|NCT03018093|"~     The trial is a single arm, single-center, non-randomized phase I clinical trial which is~     designed to evaluate the safety and efficacy of C-CAR011 in treatment of adult subjects with~     relapsed/refractory CD19+ B cells acute lymphoblastic leukemia(r/r CD19+B-ALL)~   "
41915|NCT03018080|"~     The primary objective of this study is to assess the safety and feasibility of the following~     two regimens: Cohort A) phased regimen of pembrolizumab in which paclitaxel is followed by~     paclitaxel plus pembrolizumab and Cohort B) concurrent regimen of paclitaxel plus~     pembrolizumab. The primary safety objective is to evaluate the overall grade 3 or 4~     treatment-related adverse event rate for each cohort and compare them to relevant historical~     controls.~   "
41916|NCT03018067|"~     This phase 2, single-blind, placebo-controlled study will evaluate the onset-of-action,~     safety, and efficacy of RDX227675 for the treatment of hyperkalemia. Subjects who qualify are~     randomized into one of four treatment groups: Group 1 (Placebo qd), Group 2 (RDX227675 10 g~     qd), Group 3 (RDX227675 20 g qd), Group 4 (RDX227675 30 g qd).~   "
41917|NCT03018054|"~     This is a randomized, double-blind, placebo-controlled, multi-center study to evaluate the~     efficacy and safety of E6007 once daily for 8 weeks in Japanese participants with moderate~     active ulcerative colitis. Participants will be stratified by prior therapeutic treatment and~     Mayo score at Baseline, and will be randomized 1:1:1 to receive E6007 30 milligrams (mg),~     E6007 60 mg or placebo.~   "
41918|NCT03018041|"~     This is a long-term intervention study on the effects of marine n-3 PUFAs in renal~     transplantation. Our hypothesis is that patients treated with marine n-3 PUFA supplementation~     will have less decline in kidney transplant function compared to patients treated with~     placebo.~   "
41919|NCT03018028|"~     This trial is conducted in Asia. The aim of this trial is to investigate the dose-response~     relationship of once-daily dosing of three dose levels (3, 7 and 14 mg) of oral semaglutide~     versus placebo as monotherapy on glycaemic control in Japanese subjects with type 2 diabetes~     mellitus~   "
41971|NCT03017339|"~     The purpose of this study is to investigate the effects of a functional exercise program~     associated with Low Level Laser Therapy (LLLT) on pain, functional capacity and quality of~     life of individuals with fibromyalgia. Half of participants will receive functional exercise~     and LLLT, while the other half will receive functional exercise and placebo LLLT.~   "
41920|NCT03018015|"~     The present study will be conducted in order to assess bioequivalence of the Test product~     (Ibuprofen 400 mg oral powder) and the Reference product 1 (Brufen 400 mg film-coated~     tablet), an approved market product in the European Union. Testing for bioequivalence will be~     performed considering AUC0-tlast and Cmax obtained after oral single dose fasted~     administration of ibuprofen.~      In addition to the conventional immediate release tablet used as Reference 1, a soft capsule~     formulation will be applied as Reference 2 (Spalt Forte 400 mg Weichkapseln), as an example~     for a product with a very fast absorption rate.~      All 3 immediate release preparations contain 400 mg ibuprofen.~   "
41921|NCT03018002|"~     The purpose of this study is to evaluate the comparative effectiveness of a congregation,~     clinic and integrated case management-based intervention for sustainable testing and~     retention on linkage to care, engagement, retention and viral load suppression of women and~     children infected with HIV.~   "
41922|NCT03017989|"~     Endometriosis is a common disease for which the current gold standard for diagnosis is a~     diagnostic laparoscopy with histologic confirmation. However, during the diagnostic~     laparoscopy endometriotic lesions are hard to identify due to the many appearances of~     endometriosis. Our hypothesis is that the use of intra-operative near infrared fluorescence~     imaging will provide real time image enhancement for the detection of endometriotic lesions~     by using the different vasculature in the endometriotic lesions. This hypothesis will be~     tested in a prospective study with 15 patients scheduled for an elective diagnostic~     laparoscopy for suspected endometriosis.~   "
41923|NCT03017976|"~     This study aims to assess the influence of exposure to swimming pool environment on~     respiratory symptoms and diseases, and on cancer outcomes among swimmers and swimming pool~     attendants.~   "
41924|NCT03017963|"~     The purpose of this trial is to evaluate the safety and maximum tolerable dose (MTD) of~     sodium thiosulfate in patients presenting with an acute coronary syndrome and treated with~     primary percutaneous coronary intervention (PPCI) via trans-radial approach in adjunction to~     standard treatment.~   "
41925|NCT03017950|"~     The purpose of the study is examining and comparing the pharmacokinetic drug interaction and~     safety of both single administration and combination administration of CKD-330 and D086 to~     healthy male subjects~   "
41926|NCT03017937|"~     Clinical trials have suggested that this device is effective in mitigating changes in brain~     structure and function in athlete populations. The purpose of the current study is to measure~     the response of the jugular vein to various pressures applied by a generic compression device~     across various ages and gender. The relative jugular vein response will be measured using~     ultrasound.~   "
41927|NCT03017924|"~     The purpose of the study is to monitor changes in brain structure and function between the~     pre-training and post-training, in a population of tactical team members wearing the Device~     and compared to a similar population not wearing the device. Secondly, the purpose is to~     determine the protection of the device relative to amount and magnitude of sustained head~     impacts.~   "
41928|NCT03017911|"~     This is a prospective monocentric study of PICC Line complications use in 5 medical and one~     surgical units of Brest Medical University Hospital.~      To evaluate the incidence of the following complications: infections, thromboses, mechanical~     and hemorrhagic, at month 3 post-intervention.~      Also evaluating:~        -  the management of these PICC Line related complications,~        -  risk factors for such complications,~        -  and the mortality-related outcomes.~   "
41929|NCT03017898|"~     The purpose of this study is to determine whether treatment with laser coagulation is an~     effective and safe treatment option for patients with anal fistula~   "
41930|NCT03017885|"~     This active surveillance will include all NSCLC patients treated with nintedanib per the~     inclusion/exclusion criteria at approximately 20 selected centers until it is confirmed that~     100 patients treated with nintedanib are included and that baseline characteristics of 100~     additional patients (or as many patients as in the nintedanib group if <100) planned to be~     treated with single agent docetaxel are collected from the same centres during the same time~     frame, or until a maximum of two years, whichever occurs first~   "
41931|NCT03017872|"~     D²EFT is a randomised, open-label study in HIV-1 infected patients failing first-line~     antiretroviral therapy (ART). The study compares a novel regimen of second-line ART~     (dolutegravir and darunavir pharmaco-enhanced with ritonavir) with the WHO recommended~     regimen of 2(t)NRTIs plus a ritonavir-boosted PI (Standard of Care (SOC)). 610 participants~     from 10 predominantly low-middle income countries will be followed for 96 weeks with the~     primary endpoint at week 48. The design is based on the hypothesis that the new regimen will~     be non-inferior to SOC in terms of virologic control while being easier to take, economically~     viable and affording simplification of treatment programs.~   "
41932|NCT03017859|"~     A single center, prospective study to assess the efficacy of high flow nasal cannula (HFNC)~     in improving obstructive sleep apnea (OSA) parameters in patients with reduced tolerance to~     continuous positive airway pressure (CPAP) treatment.~   "
41933|NCT03017846|"~     Cantharidin is cited in the dermatology and pediatric literature as a valuable treatment~     option. Treatment is often available in private practice offices, where a prescribing~     physician may offer a non-FDA approved treatment on an individualized basis. The situation is~     different in many hospital and academic settings, such as our own for example, where the~     formulary is defined through a FDA-approved indication. The absence of an indication~     precludes its addition to many hospital formularies, thus limiting the options available to a~     prescribing physician and denying patient access to a treatment offered in the private~     practice setting. An indication and formulary status require controlled clinical trials on~     the safety and efficacy of cantharidin in MC. The objective of this trial is to see if this~     commercially-viable cantharidin formulation has a comparable safety and efficacy profile as~     formulations previously studied under conditions which most closely match the what has been~     historically done in the clinic.~   "
41972|NCT03017326|"~     The PHITT trial is an over-arching study for patients with Hepatoblastoma (HB) and~     Hepatocellular Carcinoma (HCC). This trial will use a risk-adapted approach to the treatment~     of children diagnosed with HB.~      Children with HCC will be included as a separate cohort.~   "
41973|NCT03017313|"~     The purpose of the protocol, is to determine the percentage of patients for whom the initial~     LHRH prescription has been renewed~   "
42590|NCT03009279|"~     To investigate the association between metabolic syndrome (MS) and thyroid nodule(s).~   "
41934|NCT03017833|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of TAK-228 and metformin that can be given to patients with advanced cancer. The~     safety of the drug combination will also be studied.~      This is an investigational study. TAK-228 is not FDA approved or commercially available.~     TAK-228 is currently being used for research purposes only. Metformin is FDA approved and~     commercially available for the treatment of diabetes mellitus. The combination of these drugs~     to treat advanced cancer is considered investigational.~      The study doctor can explain how the study drugs are designed to work.~      Up to 50 participants will take part in this study. All will be enrolled at MD Anderson.~   "
41935|NCT03017820|"~     This phase I trial studies the best dose and side effects of recombinant vesicular stomatitis~     virus carrying the human NIS and IFN beta genes (VSV-hIFNbeta-sodium iodide symporter [NIS])~     in treating patients with multiple myeloma, acute myeloid leukemia, or T-cell lymphoma that~     has come back or does not respond to treatment. A virus, called VSV-hIFNbeta-NIS, which has~     been changed in a certain way, may be able to kill cancer cells without damaging normal~     cells.~   "
41936|NCT03017807|"~     A single-central,open-label,safety,pharmacokinetics,phase I study. Biological:Recombinant~     Anti-EGFr Antibody Two dose levels: Low-dose level patients received initial dose 100 mg/m2~     and 4 weeks later 250 mg/m2 weekly maintenance to the disease progression or unacceptable~     toxicity or death or withdraw informed consent.High-dose level patients received cetuximab~     initial dose 400 mg/m2 and 4 weeks later loading 400 mg/m2 and 250 mg/m2 weekly maintenance~     to the disease progression or unacceptable toxicity or death or withdraw informed consent.~   "
41937|NCT03017794|"~     This is a pilot study to test a hypothesis that a greater increase in serum chromogranin A~     (CgA) after a definitive radiotherapy (RT) with or without androgen deprivation therapy (ADT)~     is associated with a higher risk of prostate cancer recurrence after RT. Serum CgA level is~     measured before the start of RT and/or the start of neoadjuvant ADT for patients undergoing a~     definitive RT with or without ADT. CgA is also measured at various pre-defined post-RT time~     points. The study will analyze the followings: 1. Change in CgA level at various pre-defined~     post-RT time points from the baseline, 2. Correlation between the extent of post-therapy CgA~     change and Gleason score of malignancy, 3. Correlation between the extent of post-therapy CgA~     change and treatment outcome.~   "
41938|NCT03017781|"~     The primary purpose of this study is to compare, over 24 months, the time spent with~     clinically significant mood symptoms (ie, mania, depression), as measured by the Longitudinal~     Interval Follow-Up Evaluation (LIFE) and the Psychiatric Status Rating Scale (PSR), in~     offspring of bipolar parents with and without at least mild impairment in psychosocial~     functioning.~   "
41939|NCT03017768|"~     Esophageal hypersensitivity is considered an important pathophysiological mechanism in~     patients suffering form non-erosive gastro-esophageal reflux disease. Serotonin (5-HT) is~     predominantly found in the central nervous system and in the gastro-intestinal (GI) tract.~     5-HT plays a major role in the regulation of GI secretion, motility and sensitivity, and has~     been associated with emotion regulation. Acute tryptophan depletion (ATD) temporarily reduces~     the availability of tryptophan (TRP), thereby decreasing central and peripheral 5-HT~     synthesis. From previous studies, ATD is known to affect GI physiology and enhance visceral~     pain perception in the colon. The aim of the study was to investigate the effect of ATD on~     esophageal sensitivity in healthy volunteers (HV).~      Esophageal multimodal sensitivity was assessed after intragastric infusion of an amino-acid~     mixture (AA-mix) containing 15 AAs with TRP (control condition) or without TRP (ATD~     condition). After an incubation period of 5 hours, a probe with a polyurethane bag was~     positioned in the distal esophagus. Thermal (recirculating a heated saline solution through~     the bag), mechanical (increasing bag volume), electrical (2 stimulation electrodes) and~     chemical sensitivity (modified Bernstein) were tested and at 3 time points blood samples were~     collected for biochemical analysis. General mood was assessed by the Positive and Negative~     Affect Schedule (PANAS) and the State-Trait Anxiety Inventory (STAI) questionnaires.~   "
41940|NCT03017755|"~     This is a survey to help understand the influences related to the decision for Adolescent~     Idiopathic Scoliosis treatment (observation vs. bracing vs. surgery). The investigator then~     plans to create a decision aid to help families when making a decision about the treatment~     choice being presented to them.~   "
41941|NCT03017729|"~     The purpose of this study is to assess the longitudinal attainment of subject centred and~     functional related goals (cumulated Goal Attainment Scale Total (GAS T) score) after~     abobotulinumtoxinA injection (including following repeated injection cycles where they occur)~     alongside spasticity management used in real life settings over a period of 18 months (and a~     maximum of six injection cycles).~   "
41942|NCT03017716|"~     Articular involvement is the most frequent extra-intestinal manifestation of inflammatory~     bowel diseases (IBD). IBD-related spondyloarthropathy is mainly characterised by axial~     involvement (including inflammatory back pain, isolated sacroiliitis and ankylosing~     spondylitis) but may also be associated with peripheral symptoms (i.e peripheral arthritis,~     dactylitis and enthesopathy, such as Achilles tendinitis, plantar fasciitis, and chest wall~     pain). In particular, inflammatory back pain (IBP) is characterised by an insidious onset,~     improves after exercise but not with rest, and is associated with morning stiffness. Up to~     now, several criteria sets have been proposed to define IBP. Studies conducted in various~     populations have confirmed a high sensitivity and specificity for the Berlin criteria. Celiac~     disease (CD) is an autoimmune systemic disease having among its clinical manifestations~     frequent symptoms common to rheumatologic diseases. Recently, it has been reported that a~     consistent percentage of the general population consider themselves to be suffering from~     problems caused by wheat and/or gluten ingestion, even though they do not have CD or wheat~     allergy. This clinical condition has been named Non-Celiac Gluten Sensitivity' (NCGS) or~     Non-celic Wheat Sensitivity (NCWS). The clinical picture of NCWS is characterized by combined~     gastrointestinal and extra-intestinal or systemic manifestations. Many patients affected with~     CD and NCWS complain of IBP-like symptoms, which generally improve, together with the other~     clinical manifestations of the diseases, during a gluten-free diet (GFD). Therefore, the aims~     of the present study are to investigate 1) the effect of a GFD in IBP patients, randomly~     assigned to receive standard therapy for IBP or standard therapy for IBP plus GFD, for a~     period of at least one year, and 2) the prevalence of IBP in CD and in NCWS patients.~   "
41943|NCT03017703|"~     The importance of Aldosterone for endothelial function and Insulin resistance observed within~     patients with type 2 diabetes~   "
41944|NCT03017690|"~     An observational time and motion study in a clinical oncology setting is utilized in order to~     measure and compare product attributes and overall product efficiency between lanreotide and~     octreotide LAR.~   "
41948|NCT03017638|"~     Pain after abdominal surgery can be extensive. Pain control is an important component of~     patient comfort and participation in rehabilitation. Multimodal analgesia methods have shown~     to reduce postoperative pain, and have been addressed to be a crucial part of the Enhanced~     Recovery after Surgery (ERAS) protocols.~      Quadratus lumborum block (QLB) is a posterior abdominal wall block which analgesic efficacy~     has been shown for abdominal surgeries, and also for different laparoscopic procedures, such~     as ovarian surgery.~      The aim of this study is to assess QLB's analgesic efficacy for laparoscopic colectomy~     surgeries, using serial pain score assessments and overall opioid consumption; its effect on~     patient satisfaction; and its effect on the development of postoperative respiratory~     complications. This study is a prospective clinical trial assessing the effect of application~     of QLB as a regional analgesic technique for primary laparoscopic colectomy, in comparison to~     a historical retrospective cohort.~   "
41949|NCT03017625|"~     Chronic obstructive pulmonary disease (COPD) is known for development of severe~     cardiovascular co-morbidities. Systemic inflammation during acute exacerbations of COPD~     (AE-COPD) is thought to play a role in development of cardiovascular disease. Platelets~     contribute to acute cardiovascular events and atherosclerosis. When platelets are activated,~     they form complexes with monocytes. These platelet-monocyte complexes (PMCs) are an early~     process in atherothrombosis and promote inflammation. In COPD, platelet function in AE-COPD~     is scarcely studied. This study aims to address this gap by investigating platelet function~     and coagulation in patients with AE-COPD and after convalescence.~   "
41950|NCT03017612|"~     The objective of this study is to evaluate the safety and effectiveness of the Raindrop Near~     Vision Inlay implanted in bilateral pseudophakes with presbyopia for improvement of near and~     intermediate vision. The ReVision Optics corneal inlay is a 2.0-mm, 30-micron inlay made of a~     hydrogel material, implanted under a lasik flap. Subjects must require reading add from +1.50~     D to +2.50 D. Subjects must have a preoperative manifest refraction spherical equivalent of~     -0.50 to +1.00 D with no more than 0.75 D of refractive cylinder. The Raindrop Near Vision~     Inlay will be implanted in the non-dominant eye.~   "
41951|NCT03017599|"~     To investigate the technical feasibility and diagnostic yield of new 20-gauge Procore needle~     for EUS-guided fine needle biopsy in pancreatic solid lesions.~   "
41952|NCT03017586|"~     The purpose of this study is to evaluate the safety and effectiveness of deep brain~     stimulation (DBS) of the subthalamic nucleus (STN) and globus pallidus internus (GPi) for~     primary dystonia.~   "
41953|NCT03017573|"~     SCANDARE is a prospective biobanking study on tumor (+/- nodes), plasma and blood samples at~     different time points in ovarian, triple negative breast and head and neck cancer patients.~     This study will allowed to identify new molecular and/or immunological biomarkers associated~     with clinical and biological features of the tumors. All patients will receive standard~     treatment according to the stage of the diseases and usual procédures.~   "
41954|NCT03017560|"~     The primary purpose of this study is to test the effects of a targeted, computerized~     cognitive training program on verbal memory in older women who have undergone chemotherapy~     treatment for early-stage breast cancer. As measured by neuropsychological assessment, this~     treatment will result in improved verbal memory. Secondarily, processing speed and naming~     abilities are expected to improve. Enhanced self-perception of cognitive ability is also~     expected.~   "
41955|NCT03017547|"~     Acute Respiratory Distress Syndrome (ARDS) patients will be randomized to receive either IC14~     (a single dose of 4 mg/kg followed by 2 mg/kg on Days 2-4) or placebo. Study participation~     will be for a total of 28 days.~   "
41956|NCT03017534|"~     The mechanism responsible for improvement following manual physical therapy techniques is~     unknown. Previous studies have indicated both biomechanical and neurophysiologic effects~     which may be responsible for clinical changes observed. Yet, other studies report clinical~     changes following sham interventions. Through a mixed-methods design, this study aims to gain~     more understanding of the social and contextual factors that may be related to the~     improvement often observed following manual therapy techniques.~   "
41957|NCT03017521|"~     The phosphatidylinositol 3-kinase (PI3K)-v-akt murine thymoma viral oncogene homolog~     (AKT)-mammalian target of rapamycin (mTOR) signaling pathway is one of the most frequently~     aberrantly regulated pathways in human tumors. TAS-117 is a highly potent and selective oral~     allosteric AKT inhibitor. It has high affinity for AKT1, 2, and 3 and shows potent~     anti-proliferative activity against multiple tumor cell lines in vivo. Therefore, we propose~     to conduct a phase II trial of TAS-117, potent and selective AKT inhibitor, in patients with~     advanced solid tumor with PI3K/AKT genetic aberrancy by NGS focusing panel in part of~     K-BASKET trial.~   "
41958|NCT03017508|"~     The goal of the current proposal is to examine if sublingual riluzole can reduce anxiety in~     people with social anxiety disorder during a public speaking task.~   "
41959|NCT03017495|"~     The main objectives of this phase 1 trial are to evaluate the effect of food on the~     pharmacokinetics (i.e. how long and how much a compound is present in the blood) of~     ACT-541468 and to evaluate whether ACT-541468 can affect the pharmacokinetics of midazolam, a~     CYP3A4 substrate.~   "
41960|NCT03017482|"~     The purpose of this project is to track initiation and the first year of clinical use of the~     newly FDA approved 670G closed loop insulin delivery system by patients who have requested~     this system. Our goal is to evaluate our clinical approach to starting this newly approved~     system. Since the investigators are only following patients who have already decided to start~     the 670G, the investigator does not assign specific interventions to the subjects of the~     study; thus this is a Observational study.~   "
41974|NCT03017300|"~     Inspiratory muscle training（IMT）was an rehabilitation therapy for stable patients with~     chronic obstructive pulmonary disease(COPD). However, its therapeutic effect remains~     undefined due to unclear of diaphragmatic mobilization during IMT. Diaphragmatic mobilization~     represented by transdiaphragmatic pressure（Pdi）and neural respiratory drive expressed as~     corrective root-mean-square(RMS) of diaphragmatic electromyogram(EMGdi) provide vital~     information to select the proper IMT device and loads in COPD, therefore make curative effect~     of IMT clarity. Pdi and RMS of diaphragmatic electromyogram (RMSdi%) was respectively~     measured and compared during inspiratory resistive training and threshold load training in~     stable patients of COPD.~   "
41975|NCT03017287|"~     The study will evaluate the safety and efficacy of computerized GlucoMe App in patients with~     uncontrolled diabetes treated with MDI.~   "
41961|NCT03017469|"~     Nurses are exposed to myriad stressors, both in the workplace and in their everyday lives,~     which can lead to adverse personal and professional outcomes. While workplace stress cannot~     be eliminated, nurses can learn techniques to build resilience, mitigate stress, and decrease~     fatigue. Organizational employee health, wellness, and assistance programs are all~     intentioned to provide this type of support; however, nurses often lack awareness of options~     and opportunities, and access can be a challenge. The purpose of the proposed study is to~     assess the outcomes of a multi-modal intervention and toolkit, ARISE, designed to enhance~     resilience and promote awareness of organizational resources for health, wellness, and~     employee assistance. We will evaluate the impact of participation in ARISE on resilience and~     other outcomes in nurses in critical care and trauma settings. As a Best Practice Spotlight~     Organization designated by the Registered Nurses Association of Ontario (RNAO), this project~     will incorporate relevant recommendations from Best Practice Guidelines (BPG) related to~     Workplace Health, Safety, and Well-being of the Nurse; and Preventing and Mitigating Nurse~     Fatigue in Health Care.~   "
41962|NCT03017456|"~     Prostate Cancer Survivorship 360º is a collaboration-based initiative involving prostate~     cancer (PC) and survivorship researchers/clinicians from three Canadian prostate centers with~     the goal of identifying and tracking unmet supportive care needs of patients with localized~     PC and responding to these needs through survivorship care. The current randomized control~     trail (RCT) will focus on the development and evaluation of a facilitated electronic Prostate~     Cancer Survivorship Care Plan (PC-SCP). The aims of this project are: 1) to develop an~     appropriate and tailored SCP and transition care delivery process; and 2) to conduct an RCT~     to evaluate whether a personalized PC SCP intervention is more effective than usual care (UC)~     on patient activation (primary outcome) and access to services, self-Management support,~     satisfaction with information, HRQoL and cancer worry (secondary outcomes). Data from a~     multi-site prospective database- Prostate Cancer Survivorship Information System (PC360-IS)~     will be used to electronically populate the survivorship care plans. Overall, this proposal~     represents initial steps in uniting the country in sharing programmatic resources, data,~     expertise, and enthusiasm to transform survivorship care for men with PC and their families.~   "
41963|NCT03017443|"~     The objective of this study was to determine changes in body weight and related outcomes~     achievable over a 16-week period in response to three different commercially available weight~     loss programs (Nutrisystem) providing pre-packed, portion controlled foods and beverages,~     each compared to a self-directed diet, in apparently healthy overweight and obese men and~     women.~   "
41964|NCT03017430|"~     It is a single blind randomized symptom triggered study to assess efficacy and safety of~     pregablin combined with the symptom triggered treatment for opiate withdrawal syndrome vs.~     clonidne with the same with the symptom triggered treatment for opiate withdrawal syndrome.~   "
41965|NCT03017417|"~     The proposed study will assess the feasibility of an exercise and dietary intervention in men~     with castrate resistant prostate cancer with secondary outcomes assessing improvements in~     physical functioning, fatigue, quality of life, and body composition.The study will have 2~     arms, with one set of participants randomized to resistance exercise training intervention~     plus dietary advice and the other arm will be standard of care plus exercise advice.~   "
41966|NCT03017404|"~     To study the maximum tolerated dose of Doxorubicin Hydrochloride Liposome Injection~     combination with cyclophosphamide and sequential treatment of docetaxel for patients with~     locally advanced breast cancer~   "
41967|NCT03017391|"~     Nausea and vomiting are frequently occurring problems in the palliative phase of patients~     with cancer. Between 20-50% of them regularly suffer from nausea, retching or vomiting. Often~     the cause of nausea and vomiting is multifactorial and symptomatic treatment is necessary.~      Potential drugs for symptomatic anti-nausea therapy are metoclopramide, serotonin~     antagonists, the combination of both and dexamethasone as rescue medication in case of~     failure. There is no data that depicts which strategy is the best. This study will be~     conducted to unravel which treatment algorithm is most successful.~   "
41968|NCT03017378|"~     The study is a single centre, phase I, open, randomized, by intranasal and sublingual~     application trial that explored the safety and immunogenicity of 2 doses (Day 1 and Day 21)~     TB/FLU-01L tuberculosis vaccine in BCG-vaccinated healthy adult subjects aged 18-50 years.~   "
41969|NCT03017365|"~     It is well documented that both balance and resistance training have the potential to~     mitigate intrinsic fall risk factors in older adults. Recently, it was shown that a~     simultaneously executed balance and resistance training, namely resistance training on uneven~     surfaces is an eligible, effective and safe alternative training program to mitigate~     intrinsic fall risk factors in older adults. However, knowledge about the effects of specific~     adductor and abductor training has advantages over traditional resistance training and~     resistance training on unstable surfaces regarding forward propulsion. Further, the effects~     of different kinds of resistance training on cognition, especially embodiment is~     investigated.~   "
41970|NCT03017352|"~     Patients with type 1 diabetes (T1D) depend on insulin therapy as substitution for the lack of~     endocrine insulin production due to an autoimmune destruction of beta-cells in the pancreatic~     inslets. Insulin therapy is based on long lasting basal insulin for controlling fasting~     plasma glucose, and short lasting mealtime insulin for the postprandial plasma glucose. The~     long term efficacy of this treatment is measured in glycated haemoglobin A1c (HbA1c) of <7.0%~     as the treatment goal.~      Intensive insulin therapy is associated with side effects such as hypoglycaemia, weight gain,~     and unwanted exaggerated excursions in PPG. This may ultimately affect treatment compliance.~      The abovementioned problems associated with insulin treatment in T1D can also be seen in~     insulin-treated patients with type 2 diabetes (T2D). However, in T2D the combination of~     insulin with glucagon-like peptide-1 (GLP-1) receptor agonist (RA) has proven effective in~     reducing the weight gain and insulin dose in insulin-treated patients with T2D without~     exacerbating the risk of hypoglycaemia.~      Exenatid is a short lasting GLP-1RA approved for treatment in T2D, and the investigators~     intend to evaluate it in a randomized, controlled trial as add-on therapy to standard insulin~     therapy for patients with T1D.~      The investigators hypothesise that the add-on of exenatide to insulin therapy in patients~     with T1D will reduce insulin requirements, glycaemic excursions and body weight and improve~     glycaemic control without increasing the risk of hypoglycaemia.~   "
41976|NCT03017274|"~     Recently it has been reported that a consistent percentage of the general population consider~     themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though~     they do not have CD or wheat allergy. This clinical condition has been named Non-Celiac~     Gluten Sensitivity' (NCGS). In a previous paper the investigators suggested the term~     'Non-Celiac Wheat Sensitivity' (NCWS), since it is not known what component of wheat causes~     the symptoms in NCGS patients, and the investigators also showed that these patients had a~     high frequency of coexistent multiple food hypersensitivity. The clinical picture of NCWS is~     characterized by combined gastrointestinal (bloating, abdominal pain, diarrhea and/or~     constipation, nausea, epigastric pain, gastroesophageal reflux, aphthous stomatitis) and~     extra-intestinal and/or systemic manifestations (headache, depression, anxiety, 'foggy mind,'~     tiredness, dermatitis or skin rash, fibromyalgia-like joint/muscle pain, leg or arm numbness,~     and anemia). Nowadays no data are available on the abdominal ultrasonographic features of~     NCWS patients. Therefore, the aim of the present study is to evaluate the abdominal~     ultrasonographic features of NCWS patients in comparison with patients affected with celiac~     disease.~   "
41977|NCT03017261|"~     The goal of this prospective, non‐randomized, multicenter clinical trial is to determine~     whether robotic‐assisted total knee arthroplasty performed with TSolution One® System is safe~     and effective for use as an alternative to the conventional manual techniques. Clinical and~     radiographic outcomes for robotic‐assisted total knee arthroplasty performed with the~     TSolution One® System will be collected preoperatively, intraoperatively, and postoperatively~     up to a follow‐up period of 3 months. These outcomes will be compared to the ones reported in~     the literature for conventional manual techniques.~   "
41978|NCT03017248|"~     This study aims to determine the efficacy and safety of low dose ketamine in association with~     IV morphine in the management of acute moderate to severe pain in emergency department.~      The investigators hypothesize that low dose ketamine will result in more effective pain~     control than morphine alone and will not be associated with an increase in adverse events.~   "
41979|NCT03017235|"~     The purpose of this study is to compare the Sodium Picosulfate, Magnesium Oxide and Anhydrous~     Citric Acid Oral Solution with PREPOPIK® for colon cleansing in adult subjects undergoing~     colonoscopy.~   "
41980|NCT03017222|"~     Patients who had at least two risk factors of PONV (Postoperative nausea and vomiting) and~     underwent laparoscopic surgeries under general anesthesia were assessed for eligibility.~     Patients who developed PONV within the first 2 hours after anesthesia received intravenously,~     in a randomized double-blind manner, ondansetron 4 mg or ramosetron 0.3 mg. Patients were~     then observed for 24 hours after drug administration. The incidence of nausea and vomiting,~     severity of nausea, requirements for rescue antiemetic and adverse effects at 0-2 and 2-24~     hours after drug administration were evaluated. The primary endpoint was the rate of patients~     exhibiting complete response, defined as no emesis and no further rescue antiemetic~     medication for 24 hours after drug administration.~   "
41981|NCT03017209|"~     This study is a randomized controlled trial with a main goal to assess the effects of a~     locally-prepared food for prevention of malnutrition and stunting, in comparison with~     standard village practices and also a widely available aid food supplement in 8-12 villages~     in Guinea-Bissau. The supplement intervention will be for 24-30 weeks. The primary outcome~     will be cognitive tests of executive function. Secondary outcomes will be changes in standard~     anthropometric benchmarks of growth, hemoglobin and skin carotenoids in young children living~     in villages in rural Guinea-Bissau. This is a within-village randomization at the level of~     the family, and all children will receive a dietary intervention.~   "
41982|NCT03017196|"~     This study is designed to answer the following questions: Is the My Life, My Healthcare~     Discussion Aid feasible for use in primary care? Does it positively impact patient and~     healthcare teams' care experience and communication, while reducing patient treatment~     burden?~      Through implementation of the My Life, My Healthcare Discussion Aid for patients with chronic~     conditions, the study team hypothesizes that it will be feasible to implement in routine~     primary care practice and positively impact patient and healthcare teams experience of~     chronic care, while reducing patient treatment burden.~   "
41983|NCT03017183|"~     Study participants will be selected from clinical routine patients with endobronchial~     infiltration of a central lung cancer and indication for bronchoscopic sampling.~      Consented patients will undergo bronchoscopy for tumor sampling applying two routine sampling~     methods during one single procedure (EBUS-TBNA and conventional forceps sampling). The~     sequence of both sampling methods will be randomized in advance.~      The resulting tissue samples will be analyzed by a pathologist using multiplex PCR and FISH.~     The corresponding analysis results will be compared between sampling methods.~      Assignment of a subject to a particular therapeutic strategy is not influenced by this~     protocol. Medicinal products will be used according to current practice and marketing~     authorisation.~   "
41984|NCT03017170|"~     A randomized, double-blind, placebo controlled study to evaluate the efficacy of dried~     cranberry at 500 mg daily in women with overactive bladder for 6-months.~   "
41985|NCT03017157|"~     The study plans to investigate whether recovery of the heart function after acute anterior~     myocardial infarction is dependent upon improvement in thyroid gland functioning.~   "
41986|NCT03017144|"~     Cardiac arrest is handled by cardiopulmonary resuscitation which is a time critical emergency~     situation. The actions during resuscitation are lead by international guidelines.~     Traditionally, the main focus of the training has been on medical knowledge and technical~     skills (TS). Nowadays non-technical skills (NTS), such as communication, teamwork behaviour,~     and leadership, are considered at least equally important.~      The aim of this study is to evaluate both TS and NTS of the resuscitation team during~     real-life resuscitation situations using a validated assessment tool. The correlation of TS~     and NTS will be analyzed. Findings from this study may help to recognize the possible~     weaknesses and issues which could be improved by training. Hypothesis is that that TS are~     probably in a high level, but some improvement points of NTS are ought to be known better.~     Investigators also hypothesis that the good NTS performance in resuscitation is accompanied~     by good TS performance.~   "
42025|NCT03016637|"~     This study evaluates whether a new endoscopic ultrasonography (EUS) histology needle may~     improve the diagnostic yield during biopsies of pancreatic lesions~   "
41987|NCT03017131|"~     This phase I trial studies the side effects of genetically modified T cells and decitabine in~     treating patients with ovarian, primary peritoneal, or fallopian tube cancer that has come~     back or has not responded to previous treatments. White blood cells called T cells are~     collected via a process called leukapheresis, genetically modified to recognize and attack~     tumor cells, then given back to the patient. Decitabine may induce and increase the amount of~     the target protein NY-ESO-1 available on the surface of tumor cells. Giving genetically~     modified T cells and decitabine may kill more tumor cells.~   "
41988|NCT03017118|"~     The aim of this study is to assess whether the use of a commercially available nutraceutical,~     turmeric, is an effective option to manage pain and stiffness in patients with basal joint~     arthritis. To conduct a pilot Randomized Controlled Trial evaluating the impact of turmeric~     on basal joint arthritis.~   "
41989|NCT03017105|"~     Proximal humerus fractures (break of the top part of the upper arm bone) are common in older~     people with poorer bone quality. Often patients do not undergo surgery for these fractures:~     the bone fragments may be in an acceptable enough position to be able to heal naturally, or~     the patient may not be well enough medically to undergo an operation. These patients need to~     wear a sling to immobilise their injured shoulder, however muscles start to weaken quickly~     when they are unable to be used. This research project will look at whether strength-training~     the opposite/uninjured limb, known as cross education, has any effect on preserving the~     function of the injured/fractured limb. Participants will be randomised into two groups using~     minimisation, that is to say the groups will have balanced numbers in terms of exact pattern~     of fracture and gender. One group will receive traditional rehabilitation exercises and~     treatment by the physiotherapist for their injured limb; the other group will receive the~     same but in addition will also undergo a strength-training exercise programme for their~     uninjured limb. Only qualified physiotherapists with experience of treating this patient~     cohort will be involved. Sessions in the physiotherapy department will last up to 30 minutes~     each and will comprise of: patient review, exercise progression, and advice giving/question~     answering; home exercise programmes will be expected to be completed 2-3 times daily and last~     up to 30 minutes each; number of sessions will be agreed between the participant and treating~     physiotherapist with treating ending once an agreed, acceptable level of function has been~     achieved. The Oxford Shoulder Score patient-reported outcome measure will be completed by the~     participant at 6 and 12 weeks and the European Quality of Life (EuroQoL)-5D-5L at 12 weeks~     after commencement of treatment.~   "
41990|NCT03017092|"~     Pilot study to test feasibility of delivering a motivational smoking cessation intervention~     to low income smokers via a computer tablet.~   "
41991|NCT03017079|"~     Malnutrition and underfeeding are major challenges in caring for critically ill patients.~     Continuous feeding were thought to be better tolerated by patients with the limited~     absorptive gut surface area or gastrointestinal dysfunction, but associated with more tube~     clogging and required the patient to be attached to an infusion pump for significant periods~     of time. Intermittent infusion resembled more physiological feeding process, which allowed~     greater patient mobility and might reach goal enteral calories earlier, and the latter were~     considered to effectively decrease the length of stay (LOS)-in-hospital and mortality.~     However, it also had some previous study found that intermittent infusion had more~     complications, such as diarrhea, regurgitation than continuous. Some study found that it was~     an efficient way to prevent aspiration and reflux by increasing the enteral nutrient solution~     viscosity and improve bolus intermittent feeding intolerance. The primary goal of this was to~     study whether receiving semi-solidification of nutrients could increase the percent~     prescribed calories received by improving the feeding intolerance, and secondary goal was to~     observing the effect of semi-solid nutrient to the LOS of ICU and in-hospital, lung~     infection, 30-days mortality and the glycemic variability (GV).~   "
41992|NCT03017066|"~     The purpose of this study is to compare the gastric volume in pediatric patients who followed~     preoperative fasting guideline using ultrasound.~   "
41993|NCT03017053|"~     Cervical nodal metastasis is the most certain prognostic factor in oral cancer. Appropriate~     management of the neck is therefore of paramount importance in the treatment of oral cancer.~     However, there is still some controversy on the treatment of early maxillofacial~     malignancies. Currently, investigators have no accurate uniform treatment standards,~     including the National Comprehensive Cancer Network (NCCN) recommended between surgery and~     radiotherapy options. Clinical evaluation indicated that lymph node-negative patients~     eventually 25%-35% had cervical node metastasis. Therefore, for the majority of patients with~     true node-negative, preventive cervical lymph node dissection is obviously over-treatment,~     and lower quality of life. Radiotherapy can avoid such surgery.~   "
41994|NCT03017040|"~     The investigators hypothesize that there is no relationship between in vivo kinematic~     abnormalities and patient-rated outcomes for scapholunate interosseous ligament injuries~     (SLIL)~      The secondary null hypotheses are that: There are no kinematic differences between subjects~     with unilateral, symptomatic, full thickness scapholunate ligament tears in comparison to the~     contralateral wrist without scapholunate ligament injury.~      The investigators aim to answer to the below questions:~        -  What are baseline validated outcomes for subjects with SLIL injury?~        -  What are baseline physical measures (range of motion, Jamar Dynamometry)?~   "
41995|NCT03017027|"~     The purpose of this study is to assess the efficacy of a 10-minute therapy dog visitation~     (TDV) in reducing biobehavioral stress responses among hospitalized school-age children by~     comparing responses between TDV and non-TDV control groups.~   "
41996|NCT03017014|"~     The primary objective of this study is to evaluate long-term effectiveness of adalimumab in~     pediatric participants starting a treatment for Crohn's disease in real life conditions,~     namely to describe the time to loss of clinical benefit in a time to event approach. Main~     secondary objectives are to describe growth and pubertal development and to describe~     long-term safety. The participants will be followed-up up to 10 years.~   "
41997|NCT03017001|"~     Omega-3 polyunsaturated fatty acids (w-3-PUFA) may have a potential role in enhance the~     postoperative balance of host immunity and reduce the incidence of postoperative atrial~     fibrillation (POAF). CHO drinks 2h before the induction of the anesthesia may reduce the~     necessity of vasoactive drugs preoperatively. the aim of this study was to investigate the~     effect of these two nutrients in patients undergoing CABG with cardiopulmonary bypass (CPB)~     on morbidity at ICU, mainly POFA. This is a double-blind controlled randomized trial.~   "
41998|NCT03016988|"~     Mantle cell lymphoma (MCL) is a type of non-Hodgkin's lymphoma (NHL) and shows poor survival.~     This study to evaluate the efficacy and safety of Bortezomib combined with Fludarabine and~     Cytarabine treatment in the naive and relapsed MCL who are not eligible for high dose therapy~     and transplantation.~   "
41999|NCT03016975|"~     To establish the safety and effectiveness of the Edwards Cardioband System in patients with~     functional mitral regurgitation (FMR).~   "
42000|NCT03016962|"~     The potential benefit of using the cap is that it helps in luminal orientation at bends by~     keeping the colonic mucosa away from the lens at the colonoscope tip. Colonoscopy in patients~     with a history of abdominal surgery is considered to be difficult due to adhesion-related~     bowel angulations. There were few study evaluating usefulness of cap-assisted colonoscopy in~     patients with prior abdominal surgery. The investigators designed a randomized, controlled~     trial to verify the usefulness of cap-assisted colonoscopy in patients with prior abdominal~     surgery.~   "
42001|NCT03016949|"~     The study will evaluate the humoral immunogenicity in various schedule combinations of full~     dose inactivated polio vaccines (IPV) via intramuscular administration (IM) and of the~     fractional dose of inactivated poliovaccine (f-IPV) via intradermal administration (ID).~   "
42002|NCT03016936|"~     Multicentre international prospective cohort study designed to answer the question: In~     patients undergoing elevated risk noncardiac surgery, are METs estimated by questionnaire~     associated with perioperative major adverse cardiovascular events or cardiovascular~     mortality? If so:~        1. What is the optimal cut-off for METs estimated by questionnaire to predict perioperative~          major adverse cardiovascular events or cardiovascular mortality?~        2. How does the optimal cut-off compare with the currently guideline-endorsed 4-MET~          cut-off?~   "
42003|NCT03016923|"~     The proposed pilot study seeks to explore the effectiveness of Functional Electrical~     Stimulation (FES) to improve upper limb function in children and youth (aged 6 to 18 years)~     with hemiplegic cerebral palsy, as measured by the QUEST grasp score and other secondary~     outcome measures obtained pre- and post-intervention in a case series study design.~   "
42004|NCT03016910|"~     Unstable plaque, the primary cause of myocardial infarction, is characterized by distinct a~     morphology including positive remodeling (PR), low attenuated plaque (LAP), napkin ring sign~     (NRS), and spotty calcifications (SC) The purpose of the present study is to investigate the~     influence of microvascular dysfunction and additional risk factors on plaque morphology and~     plaque burden in patients with diabetes mellitus.~   "
42005|NCT03016897|"~     ALS AT HOME is a single-center study of up to 250 participants being done to determine the~     extent to which frequent sampling can improve the qualities of outcome measures collected at~     home by study participants.~   "
42006|NCT03016884|"~     The reactivation of varicella zoster virus (VZV) (herpes zoster (HZ)) is of substantial~     public health concern. Updated ACR recommendations for RA treatment suggest that RA patients~     aged ≥ 50 years should be vaccinated before receiving biologic or tofacitinib therapy. The~     Investigators therefore propose a prospective study to evaluate the safety, tolerability, and~     immunogenicity of a zoster vaccine (Zostavax) in patients with RA, administered at least 2~     weeks prior to initiation of anti-TNF biologic and tofacitinib therapy for RA.~      This is a 6-week open-label prospective multi-center study evaluating the safety,~     tolerability, and immunogenicity of Zostavax vaccine in the RA population prior to initiation~     of biologic/tofacitinib therapy for RA. VZV-specific immune response to vaccine in RA~     patients will be compared to healthy control subjects ≥ 50 years immunized with Zostavax.~   "
42007|NCT03016871|"~     This phase II trial studies the side effects of nivolumab and to see how well it works when~     given together with ifosfamide, carboplatin, and etoposide in treating patients with Hodgkin~     lymphoma that has come back and does not respond to treatment. Monoclonal antibodies, such as~     nivolumab, may interfere with the ability of cancer cells to grow and spread. Drugs used in~     chemotherapy, such as ifosfamide, carboplatin and etoposide, work in different ways to stop~     the growth of cancer cells, either by killing the cells, by stopping them from dividing, or~     by stopping them from spreading. Giving nivolumab, ifosfamide, carboplatin and etoposide may~     work better in treating patients with Hodgkin lymphoma.~   "
42008|NCT03016858|"~     With the development of video-assisted thoracoscopic surgery (VATS) techniques and technology~     for anesthesia control, non-intubated anesthesia with spontaneous ventilation has been widely~     applied in VATS. A multicenter randomized parallel controlled study was applied in this study~     to assess the feasibility and safety of thoracoscopic bullectomy surgery under intravenous~     anesthesia with spontaneous ventilation versus tracheal intubation general anesthesia.~   "
42009|NCT03016845|"~     Optimal understanding of ciprofloxacin pharmacokinetics in critically ill patients is lacking~     resulting in large variation of achieved exposure and possible inadequate therapy. The~     investigators hypothesize that drug dosing based on CKD-EPIcr-cys provides a useful method to~     individualize and optimize therapy for ciprofloxacin and eventually improve outcome.~      In a multi-centre, observational, open-label study the investigators aim to define : the~     model for estimation of renal function that most accurately predicts ciprofloxacin clearance~     in critically ill patients.~   "
42010|NCT03016832|"~     1. Name of Investigational Products Huangkui capsule.~        2. Trial Topic A Randomized, Double-blinded, Parallel, controlled, Multicenter Clinical~          Trial of Huangkui Capsule in Treating Type II Diabetic Nephropathy (DKD)~        3. Trial Objectives Primary objective:To evaluate HuangKui capsule efficacy for treatment~          of type II diabetes ACR.~           Secondary objective: To evaluate the efficacy of HuangKui capsule on 24-hour urinary~          protein changes、reduce PCR-increase eGFR, improve micro-inflammatory state, and~          improving Traditional Chinese medicine clinical efficacy~        4. Trial Design Designed as a block randomized, double-blinded, parallel controlled,~          multi-center clinical trial.~   "
42011|NCT03016819|"~     This study evaluates the safety and efficacy of AL3818 (anlotinib) hydrochloride in the~     treatment of metastatic or advanced alveolar soft part sarcoma (ASPS), leiomyosarcoma (LMS),~     and synovial sarcoma (SS). All participants with ASPS will receive open-label AL3818. In~     participants with LMS or SS, AL3818 will be compared to IV dacarbazine. Two-thirds of the~     participants will receive AL3818, one-third of the participants will receive IV dacarbazine.~   "
42012|NCT03016806|"~     This study is a single-center, treatment protocol with 4 possible preparative regimens,~     designed to validate the process of umbilical cord blood stem cell transplantation at our~     institution.~   "
42026|NCT03016624|"~     To compare coronary healing after optical coherence tomography guided versus conventionally~     angiography guided percutaneous coronary intervention with the Magmaris bioresorbable~     scaffold.~   "
42027|NCT03016611|"~     To examine the efficacy of chewing Ticagrelor versus Prasugrel in ST-elevation Myocardial~     Infarction (STEMI) patients on platelet reactivity.~   "
42013|NCT03016793|"~     P-patients with unilateral alveolar clefts I-purabone with -β-tricalcium phosphate graft~     C-β-tricalcium phosphate graft alone O-clinical out come Outcome name Measurement device~     Measurement unit Esthetic satisfaction (Primary outcome) Numerical rating scale(NRS) Number~     0—10~      Radiographic outcome:~      Outcome name Measurment Device Measurment unite Bone volume~      (Secondary out come) (CBCT)machine Cranex 3D Sordex Cubic millimeter Bone Density~      (Secondary Outcome) (CBCT)machine Cranex 3D Sordex Hounsfield Unite Research Question Would~     purabone addition to β-tricalcium phosphate be more effective and esthetically satisfying~     than tricalcium phosphate alone in alveolar cleft grafting?~   "
42014|NCT03016780|"~     Ulcerative colitis is a common digestive system disease, the incidence is increasing in~     recent years.It is reported that the occurrence and development of ulcerative colitis is~     closely related to imbalance of intestinal flora .Moreover,intestinal mucosal immunity may be~     related to intestinal flora. Fecal microbiota transplantation as a new technology to rebuild~     intestinal flora has been used for several disease，but the efficacy of ulcerative colitis by~     fecal microbiota transplantation needs to be further explored.~   "
42015|NCT03016767|"~     Oral feeding in the neonatal period requires an accurate coordination between suction,~     swallowing and breathing. In premature new-borns and, depending on their gestational age, the~     coordinated work of those processes becomes jeopardised, being necessary to begin with an~     artificial enteral feeding. This situation results in lengthen their stay at the hospital~     until they are able to respond in a reliable way to their nutritional requirements orally,~     maintaining an adequate daily weight gain and without endangering their cardiorespiratory~     system.~      This project is an experimental, prospective, blinded, randomized study, aimed to determine~     whether the application of a manual oral stimulation protocol in premature infants,~     hospitalized in a neonatal unit, reduces the transition time from enteral feeding to oral~     full feeding, while improves quality of feeding and shortens hospitalization time.~   "
42016|NCT03016754|"~     This study is designed as a multi-center prospective observational study of newly diagnosed~     Heart Failure (HF) patients to test the hypothesis that additional Ejection Fraction (EF)~     recovery occurs between 90 and 180 days as Guideline Directed Medical Therapy (GDMT) is~     achieved. Although the study doesn't start until day 90, all eligible, consenting patients~     will be entered into a registry at the start of wearable cardioverter defibrillator (WCD)~     use. The pre-study registry will allow us to collect early (90 day) outcomes and data in~     those patients who are likely to be eligible for the study at day 90, or are eligible, but~     refuse the study at day 90.~   "
42017|NCT03016741|"~     This clinical trial studies cognitive function in men with prostate cancer treated with~     androgen receptor directed therapies such as abiraterone acetate and enzalutamide. The~     investigators use MRI imaging (non-invasive, non-contrast) to see whether there are changes~     in brain structure or activity related to treatment that may be related to changes in~     cognitive function. The investigators are also looking for genetic variations that might make~     patients more or less sensitive to cognitive changes during treatment for prostate cancer.~   "
42018|NCT03016728|"~     More adolescents and young adults are surviving cancer than ever before. Many endure negative~     effects related to their cancer and its treatment, which reduces their quality of life and~     functioning. Physical activity is one strategy that has been shown to promote quality of life~     amongst cancer survivors. However, very little research has focused on adolescent and young~     adult cancer survivors. Therefore, the purpose of this pilot randomized controlled trial is~     to explore the feasibility, safety, and potential benefits of a 12-week home-based physical~     activity intervention in adolescent and young adult cancer survivors.~   "
42019|NCT03016715|"~     : Epidermolysis bullosa (EB) simplex is a rare orphan disease caused by a mutation in DNA~     leading to abnormal dominant keratins in the skin. Patients with EB simplex develop lifelong~     painful thick soles on their feet, and current standard of care is supportive. This pilot~     study will target the dominant mutant keratin proteins in the skin to ameliorate the severity~     of EB simplex. The purpose is to improve the function of EB simplex feet with an application~     of topical sirolimus, 2%. The investigators plan on inhibiting the mTOR pathway to down~     regulate the translation of defective keratin proteins and work through anti proliferative~     pathways.~   "
42020|NCT03016702|"~     The purpose of this study is to test whether two new cognitive stress tests may help~     distinguish between people at lower or higher genetic risk of Alzheimer's Disease. The~     investigators are trying to understand how these cognitive stress tests work in people who~     have not been diagnosed with Alzheimer's Disease and are not exhibiting symptoms of~     Alzheimer's Disease. Study subjects will undergo testing of memory and executive function~     during functional magnetic resonance image (fMRI) of the brain and also during a walking~     test.~   "
42021|NCT03016689|"~     While the maternal-newborn exchange of airway microbiota is well-documented, no studies have~     examined within-subject relationships among the mouth, sinuses, nasopharynx and lungs and the~     relative abundance of bacterial taxa at those sites. Recent evidence suggests the oral cavity~     may serve as a reservoir for pathogens that translocate to non-oral locations;~     oral-associated microbes infect most other body sites as evidence by 16S sequencing.~      By using a combination of oral and throat swabs, together with nasal suction of mucus~     samples, the investigators will use metagenomic sequencing to characterize the composition of~     bacterial communities at each anatomical site. Beginning at birth, a time-series of swabs~     will be collected from each subject, and monitor changes in the development of microbiota~     over time. By doing so, our studies will illuminate airway trafficking of both beneficial and~     pathogenic microbes and may represent an essential pathophysiological step towards shifting~     the balance between airway health and disease.~   "
42022|NCT03016676|"~     This study will give a new insight to the physiotherapy fraternity in the effects of spinal~     manipulation in as clinical practice, as well as the patient's community in quick~     re-establishment of functional ability, pain decrease, and improvement of quality of life for~     economic reasons. In this high opinion, application of short-term intensive spinal~     manipulation for non specific chronic low back pain treatment is desirable.~   "
42023|NCT03016663|"~     Prospective observational study to evaluate effects on washing to improve viability of fat~     grafts in breast lipofilling.~   "
42024|NCT03016650|"~     The investigators aimed to evaluate tramadol-sparing effect of intravenous (IV) ibuprofen in~     patients undergoing percutaneous nephrolithotomy (PCNL).~   "
42028|NCT03016598|"~     This study will investigate the effects of intranasal administration of oxytocin, a social~     neuropeptide, on reducing cocaine use, enhancing therapeutic engagement, and susceptibility~     to stress-induced relapse in Veterans with cocaine use disorder and enrolled in opioid~     replacement therapy (ORT) program for co-occurring opioid use disorder (OUD).~   "
42029|NCT03016585|"~     Fibromyalgia (FM) is an idiopathic disease affecting approximately 3% of the world~     population, primarily diagnosed in middle-aged women. Although FM is mainly characterized by~     chronic pain and fatigue, reduced muscular strength and flexibility are common symptoms~     associated with the presentation of the disorder. Interestingly, the etiology and underlying~     mechanism of FM are not completely understood, but previous findings suggest that autonomic~     dysfunction may explain some of the FM symptoms.~      Compared to age-matched healthy individuals, patients with FM have an attenuated autonomic~     function which is associated with a reduction in vagal tone and increase in sympathetic~     activity. Therefore, autonomic function is a worthwhile target intervention in individuals~     with FM. Although traditional exercise ( both aerobic and resistance) has been shown to~     effectively improve HRV parameters and FM symptoms, most FM patients display a decline in~     adherence to traditional exercise and continue to experience considerable pain and fatigue~     years after the original diagnosis ultimately requiring medication to control their~     symptoms.Thus, new approaches are needed to improve autonomic function and clinical symptoms~     in patients with FM, which will ultimately improve their physical and emotional functioning~     leading to a better quality of life.~      Tai Chi (TC) is a form of ancient Chinese martial art which integrates slow movements,~     controlled breathing and mental concentration. TC training is safe for special populations~     and has previously shown to decrease pain, fatigue as well as other FM related~     symptoms.However, the potential role of TC training on autonomic function is largely~     unexplored.~      The investigators hypothesis is that 12 weeks of TC training would improve our primary~     outcome of autonomic function through improvements in sympathovagal balance, and the~     secondary outcomes measures of FM symptoms (pain, fatigue and sleep quality), strength and~     flexibility.~   "
42030|NCT03016572|"~     This research study is designed to answer specific questions about new ways to provide~     services for youth at-risk of suicide.~   "
42031|NCT03016559|"~     The purpose of this study are to compare angles of hip joint between before and after~     releasing quadratus lumborum muscle.~   "
42032|NCT03016546|"~     Depression is a common perinatal complication that can have a profound, adverse effect on~     maternal and child health outcomes. The proposed study will directly address this important,~     but understudied area by evaluating the feasibility and preliminary effect of an innovative,~     integrated intervention approach, BEST-maCARE [Better Education, Support, Treatment for~     maternal Capacity, Adherence, REtention in care]. The multi-component intervention is guided~     by a model drawn from self-regulation and bioecological systems theory. Proactive counseling~     personalized to the patient and socio-cultural context is delivered by trained clinic~     personnel (e.g., counselors) to build problem solving and coping skills and linkages to~     mental health, HIV treatment and ancillary services. The theory-guided intervention approach~     has been found effective in improving the health behavior and outcomes (e.g., virologic) of~     vulnerable, marginalized HIV+ women and men in rural and urban settings in the US~     (AI38858-ACTG 731; R01NR05108). Although the investigators formative research suggests that~     it is well suited for the target population, its usefulness in addressing significant gaps in~     care among perinatal women.~      l women with co-morbid conditions in a different socio-cultural, limited resource setting has~     not been studied.~   "
42033|NCT03016533|"~     Dolutegravir (DTG) is a potent inhibitor of the human immunodeficiency virus type 1 (HIV-1)~     integrase that has been developed for the treatment of HIV. This is a phase 3b (PH3b),~     non-randomized, open-label, multi-center, treatment rollover study. The primary objective of~     this pediatric interventional study is to provide continued access to DTG for eligible~     participants who previously participated in the international maternal pediatric adolescent~     acquired immunodeficiency syndrome [AIDS] clinical trials (IMPAACT) P1093 study (parent~     study) and who cannot locally access DTG in the public sector. The P1093 study was designed~     to evaluate the pharmacokinetics (PK), safety, tolerability and antiviral activity of DTG in~     HIV-1 experienced adolescents and children as well as treatment-naive infants and toddlers.~     Participants who have no evidence of virological failure (VF) and who have tolerated DTG in~     the parent study without any significant toxicity leading to the permanent discontinuation of~     this drug and withdrawal from the parent study will be considered for this open-label~     continued access study. Participants will be receiving their age/weight appropriate dose of~     DTG as defined in the parent study. The objective of this study will be supported through~     evaluation of serious adverse events. The duration of participant accrual into the study will~     extend until DTG receives local (by country) regulatory approval . Therefore, participants~     enrolled into this study will be those who will benefit from treatment and will continue to~     receive DTG until local (by country) regulatory approval and commercial or other availability~     occurs from another source (e.g. government programs, aid programs, assistance programs,~     etc.). Participants will be enrolled after all screening procedures have been completed. In~     most cases, the Screening visit will overlap with the participant's penultimate visit on the~     parent study (at Week 180 of P1093). Participants who meet all entry criteria may enroll and~     will be seen in the clinic every 12 weeks for a safety evaluation and to receive DTG. It is~     estimated that no more than 120 participants will be enrolled in this study.~   "
42034|NCT03016520|"~     The purpose of this study to Compare the safety and pharmacokinetics of DWJ1392 and DWC20164~     in healthy male volunteers.~   "
42035|NCT03016507|"~     The objective of this study is to evaluate the IOP variation before and 30 days after~     performing phacoemulsification through pneumatic tonometry, in addition to evaluating the~     factors possibly related to this variation.~   "
42036|NCT03016494|"~     The purpose of this study is to compare the safety and pharmacokinetics between~     co-administration and fixed dose combination of DWC20155 and DWC20156 in healthy subjects~   "
42037|NCT03016481|"~     This is a 3-year comparative effectiveness study funded by the Patient Centered Outcomes~     Research Institute (PCORI) and will test an adapted priority-based patient navigation versus~     care as usual among 300 survivors of intimate partner violence (IPV) recruited from, and/or~     referred from, University of Rochester Medical Center providers. The goal is to improve~     patient safety, depression, and health function over the course of 12 months. In the~     Community Health Worker -Personalized Support for Progress (CHW-PSP) arm, created and tested~     in our first UR PCORI grant, in addition to meeting with a social worker, patients will work~     with a Community Health Worker (CHW) to complete a prioritization tool and meet as needed~     over the course of the next 6 months to navigate services and overcome barriers. In addition,~     patients will receive referrals to other professionals based on their prioritization and meet~     with the CHW at the time and place of their choice. Patients in the Care as Usual- Social~     Worker (CAU-SW) arm, will do intake with a social worker, who follows hospital procedures for~     intake and referrals, does a needs assessment, and offers safety planning in referral.~   "
42038|NCT03016468|"~     This is a multicenter, single-arm trial to evaluate the safety of the transition from~     Selexipag to Remodulin® then Oral Treprostinil in Symptomatic Subjects with Pulmonary~     Arterial Hypertension (PAH). The study will include about 30 subjects at approximately 10~     clinical trial centers. The treatment phase of the study will last approximately 16 weeks.~   "
42073|NCT03016013|"~     The purpose of this study is to initially access the safety and effectivity of RC18 combined~     with methotrexate (MTX) in comparison with the use of methotrexate alone in participants with~     moderate to severe Rheumatoid Arthritis (RA) who have an inadequate response to MTX therapy.~   "
42039|NCT03016455|"~     This study aims to better characterise B cell phenotype and functional abnormalities in~     kidney transplant patients producing donor specific antibody (DSA) and in those with chronic~     antibody mediated rejection (cAMR) and to search for a predictive tool (biomarker). The~     functional analysis will help to better understand B cell-dependant mechanisms implied in T~     cell proliferation and better target future treatments.~   "
42040|NCT03016442|"~     Effıcacy of dinoprostone vaginal insert versus double- balloon catheter among women in the~     induction of labor~   "
42041|NCT03016429|"~     This protocol outlines a prospective study evaluating safety and clinical outcomes of~     magnetic resonance imaging (MRI) examinations performed on patients with cardiac implantable~     electrical devices (CIEDs) including pacemakers (PMs) and implantable~     cardioverter-defibrillators (ICDs). This prospective study aims to improve the evidence base~     regarding this common clinical scenario. Specifically, the investigators aim to address~     whether results of MRI in PM/ICD patients affect physician decision making related to~     clinical management strategy and planning treatment interventions. Further, this study will~     evaluate whether the results of MRI in these patients affects patient outcomes related to~     survival and adverse events during or after MRI scanning.~   "
42042|NCT03016416|"~     Autonomic dysfunction is a common complication of stroke that may lead to poor rehabilitation~     outcomes and to increase in mortality. The severity of the autonomic dysfunction can be~     measured in many ways, but the most common way is assessment of the~     sympathetic-parasympathetic equilibrium by heart rate variability analysis. It is known that~     the plasticity of the brain can influence the autonomic nerve system and that providing~     appropriate stimuli encourages these changes. It was found that stimulation of rhythm,~     stimulation of cognitive tasks and stimulation of activity, influence the autonomic nerve~     system in healthy subjects. Thus, we can ask if an integrated task (activity, cognitive,~     rhythm) may influence the autonomic nervous system and cause an increase in brain activity,~     therefore contributing to the rehabilitation of stroke patients. Taken together, the purpose~     of this study is to examine the influence of stimulation of rhythm, stimulation of cognition,~     stimulation of activity and combined stimulation, on the autonomic nerve system. This effect~     will be tested by measuring heart rate variability in chronic stroke patients and in a~     control group.~   "
42043|NCT03016403|"~     Medically under-served (i.e., low-income, uninsured, underinsured) cancer patients generally~     encounter significant disparities in accessing care for their mental health needs while~     undergoing toxic treatments that provide considerable physical and emotional stress. Thus,~     the investigators propose to adapt evidence-based strategies to a stepped-care intervention~     model to address the mental health needs of under-served lung cancer (LC) and head and neck~     cancer (HNC) patients and their caregivers across several levels of symptom severity (e.g.,~     mild, moderate, or severe symptoms of depression and anxiety).~   "
42044|NCT03016390|"~     Cardiovascular Implantable Electronic device (CIED) is a evolution therapy and number of~     patients with it are growing rapidly. Electromagnetic interference causing device malfunction~     is not uncommon, Radiofrequency Identification system is among its plausible source. Patients~     with CIEDs are at risk of exposure to this novel product in their daily living especially~     automobile keyless access system. Only informal studies have been conducted and not be~     published. Formal and systemic evaluation and tests are crucial.~   "
42045|NCT03016377|"~     This research study combines 2 different ways of fighting disease: antibodies and T cells.~     Both antibodies and T cells have been used to treat patients with cancers, and both have~     shown promise, but neither alone has been sufficient to cure most patients. This study~     combines both T cells and antibodies to create a more effective treatment. The treatment~     being researched is called autologous T lymphocyte chimeric antigen receptor cells targeted~     against the CD19 antigen (ATLCAR.CD19) administration.~      Prior studies have shown that a new gene can be put into T cells and will increase their~     ability to recognize and kill cancer cells. The new gene that is put in the T cells in this~     study makes a piece of an antibody called anti-CD19. This antibody sticks to leukemia cells~     because they have a substance on the outside of the cells called CD19. For this study, the~     anti-CD19 antibody has been changed so that instead of floating free in the blood part of it~     is now joined to the T cells. When an antibody is joined to a T cell in this way it is called~     a chimeric receptor. These CD19 chimeric (combination) receptor-activated T cells seem to~     kill some of the tumor, but they do not last very long in the body and so their chances of~     fighting the cancer are unknown.~      Preliminary results have shown that many subjects receiving this treatment have experienced~     unwanted side effects including cytokine release syndrome. In this study, to help reduce~     cytokine release syndrome symptoms, the ATLCAR.CD19 cells have a safety switch that when~     active, can cause the cells to become dormant. These modified ATLCAR.CD19 cells with the~     safety switch are referred to as iC9-CAR19 cells. If the subject experiences moderate to~     severe cytokine release syndrome as a result of being given iC9-CAR19 cells, the subject can~     be given a dose of a second study drug, AP1903, if standard interventions fail to alleviate~     the symptoms of cytokine release syndrome. AP1903 activates the iC9-CAR19 safety switch,~     reducing the number of the iC9-CAR19 cells in the blood. The ultimate goal is to determine~     what dose of AP1903 can be given that reduces the severity of the cytokine release syndrome~     to mild, but still allows the remaining iC9-CAR19 cells to effectively fight the leukemia.~      The primary purpose of this study is to determine whether receiving iC9-CAR19 cells is safe~     and tolerable and and later to determine an optimal dose of AP1903 to be given to subjects to~     alleviate severe cytokine release syndrome.~   "
42046|NCT03016364|"~     The purpose of this trial is to determine whether Application (APP) would help clinical~     doctors to adjust the dose of Oxycodone Hydrochloride Prolonged-release Tablets in advanced~     patients with cancer pain.~   "
42047|NCT03016351|"~     After the participant meets all inclusion and exclusion criteria, they will be randomized~     equally to either the Resistance Training group (RT) or Aerobic Training group (AT). Both~     groups will participate in an 8 week initial control period, followed by 8 weeks of~     supervised exercise training, followed by 8 weeks of deconditioning. All participants will~     undergo the same assessments and procedures one time prior to the initial 8 week control~     period, and at each of the three periods. Assessments include: blood draws; arterial~     stiffness testing; ultrasounds of the brachial artery to measure flow-mediated dilation~     (FMD); gluteal adipose tissue biopsies; exercise testing to determine VO2 max; body~     composition analysis via DEXA scans; ambulatory blood pressure measurement; diet analysis via~     food journals; medical history questionnaires; urine analysis for pregnancy; and activity~     monitoring via accelerometer. Total participation will be 24-26 weeks.~   "
42048|NCT03016338|"~     This is a phase 2 study of investigational drug niraparib in patients with advanced/recurrent~     endometrial cancer. The purpose of this study is to determine whether blocking a protein~     called poly (ADP-ribose) polymerase (PARP) with niraparib provides clinical benefit in~     patients with recurrent endometrial cancer, as well as to explore the possible impact of~     phosphatase and tensin homolog (PTEN) loss (loss of function of the PTEN gene) on blocking~     PARP with niraparib.~   "
42049|NCT03016325|"~     A Study to Evaluate Safety and Efficacy of Continuous 48-Hour Intravenous Infusions of HNO~     Donor in Hospitalized Patients with Heart Failure and Impaired Systolic Function~   "
42074|NCT03016000|"~     This is a randomized, multi-center,phase III study to evaluate the ability of thalidomide~     maintenance therapy to prolong relapse-free survival in diffuse large B cell lymphoma(DLBCL).~   "
42050|NCT03016312|"~     This Phase III, multicenter, randomized, open-label study will evaluate the safety and~     efficacy of atezolizumab (anti-programmed death-ligand 1 [anti-PD-L1] antibody) in~     combination with enzalutamide compared with enzalutamide alone in participants with mCRPC~     after failure of an androgen synthesis inhibitor (e.g., abiraterone) and failure of,~     ineligibility for, or refusal of a taxane regimen. Participants will be randomized to one of~     the two treatment arms (atezolizumab in combination with enzalutamide, and enzalutamide~     alone) in a 1:1 ratio (experimental to control arm) in global randomized phase. Participants~     will receive treatment until investigator-assessed confirmed radiographic disease progression~     per Prostate Cancer Working Group 3 (PCWG3) criteria or unacceptable toxicity.~   "
42051|NCT03016299|"~     The subchondral bone, formed by the subchondral bone plate and the subarticular spongiosa,~     plays a key role in supporting the articular cartilage. Marrow stimulation techniques such as~     subchondral drilling are clinically important treatment options for symptomatic small~     cartilage defects. However, The heat generated from the metal-bone interface during drilling~     due to the friction can cause thermal osteonecrosis. , recent clinical evidence suggests that~     they may induce alterations in the subchondral bone plate such as intralesional osteophytes,~     which persist and may play a role in the degeneration of the repair tissue.~      Little is known about whether they induce deleterious changes in the Human Chondral &~     Subchondral bone.~      The aim of this study was to compare the condral & Sub-chondral Histoligical damage induced~     by different drilling techniques.~      To the best of our knowledge this is the first time to inspect it, In- Situ, on Human tissue.~   "
42052|NCT03016286|"~     Hypotheses of this study are~        1. Bone myoregulation reflex (BMR) inhibits presynaptically H-reflex during whole-body~          vibration (WBV)~        2. Cooling of ankle abolishes the inhibitor effect of BMR on soleus H-reflex Aim of this~          study is to test these hypotheses.~      Methods: This study will be conducted on 10 healthy young adult males. WBV will be applied at~     35 Hz frequencies with 2 mm amplitudes. Cold pack will be applied the right ankle for 20~     minutes. The right soleus T-reflex will be recorded before WBV, during WBV, during cooling of~     the right ankle, and during WBV respectively.~   "
42053|NCT03016273|"~     Cesarean section is a surgical procedure used to deliver one or more babies. cesarean section~     is usually performed when vaginal delivery will put the mother or child's health or life at~     risk. In recent years, the number of cesarean section has risen worldwide.~   "
42054|NCT03016260|"~     RABIOPRED is an in vitro non-invasive blood test, which aims to identify patients with~     rheumatoid arthritis (RA) who are not likely to respond to anti-TNFα and methotrexate~     combination therapy.~   "
42055|NCT03016247|"~     The purpose of this pilot study is to evaluate the effect of the Trust-building weight~     Self-management Together (TRUST) intervention on weight self-management behaviors and neural~     processing in overweight/obese adolescents. Study aims include comparing the effects of the~     TRUST intervention with Enhanced Usual Care on BMI and quality of life in overweight/obese~     early adolescents and exploring differences in neural processing (DMT/TPN switching and~     reward activation).~   "
42056|NCT03016234|"~     This study is aimed to evaluate how intraocular pressure (IOP) is changed depending on~     surgical position (Trendelenburg versus reverse Trendelenburg) in the same patient and to~     compare the effects of different anesthetics on IOP (desflurane versus propofol) in patients~     undergoing laparoscopic colorectal surgery. The study design is a double-blind randomized~     controlled trial. The patients were randomly assigned to desflurane or propofol administrated~     groups and all patient are administered intravenous remifentanil continuously as adjuvant~     analgesics during anesthesia. For this study 50 to 80-year-old patients undergoing~     laparoscopic colorectal surgery without eye disease were enrolled. Mean arterial blood~     pressure, peak airway pressure, end tidal carbon dioxide, and IOP (using a Tono-pen® Avia~     tonometer) on both eyes were measured at defined intervals during the procedure.~   "
42057|NCT03016221|"~     The use of topical over-the-counter (OTC) products with a warming or cooling effect is~     widespread in the fields of sport, physiotherapy and in private households. Advertisements~     for such products promise pain relief when suffering from musculoskeletal disorders such as~     muscle tension, rheumatism or acute injuries, e.g. sprains. In literature, there are only~     little information about the efficacy and the physiological mechanisms of topical warming or~     cooling products. Therefore, the aim of this study is to investigate the local skin~     characteristics during and after an application of a topical product with a warming or~     cooling effect.~   "
42058|NCT03016208|"~     Objective: To compare the efficacy and safety of the misoprostol vaginal insert (MVI) for~     labour induction using standard (MVI-24) and adjusted (MVI-10) criteria.~      Design: Non-interventional observational case control study.~      Setting: Tertiary-care academic centre in Germany.~      Population: A cohort of 138 pregnant women ≥ 37/0 weeks undergoing labour induction.~      Methods: Induction of labour with MVI in a consecutive series of women using standard~     (MVI-24, n = 69) or adjusted (MVI-10, n = 69) criteria.~      Main outcome measures: The primary outcomes were the time from induction to delivery and the~     caesarean section rate. The secondary outcomes included the need for additional measures to~     induce labour, uterine tachysystole, tocolysis, fetal scalp blood testing, meconium-stained~     amniotic fluid, umbilical arterial pH, and Apgar score.~   "
42075|NCT03015987|"~     the investigator intended to study the effect of laser versus ultrasonic in activation of~     irrigation in post operative pain of patients have a symptomatic necrotic teeth~   "
42076|NCT03015974|"~     This study tries to identify the safe and effective treatment option for IgA nephropathy in~     children. Investigators will perform prospective registration study among 25 pediatric~     nephrology medical centers in China.~   "
42077|NCT03015961|"~     Primary Objective: The primary objective of this study is to compare postsurgical pain~     control following local infiltration analgesia (LIA) with EXPAREL admixed with bupivacaine~     HCl versus LIA with bupivacaine HCl in adult subjects undergoing open lumbar posterior spinal~     fusion surgery.~      Secondary Objectives: The secondary objectives of this study are to compare additional~     efficacy, safety, and health economic outcomes following LIA with EXPAREL admixed with~     bupivacaine HCl versus LIA with bupivacaine HCl in adult subjects undergoing open lumbar~     posterior spinal fusion surgery.~   "
42078|NCT03015948|"~     This is a single-center, randomized, double-blind, placebo-controlled, single ascending-dose~     Phase I trial.~   "
42059|NCT03016195|"~     Oral sodium supplementation is currently administered in cases of poor weight gain in infants~     particularly in patients who have undergone gastrointestinal surgical procedures. The~     decision to start oral supplementation is based on urinary sodium levels although the level~     at which to start treatment is variable as the range in normal, healthy infants is unknown.~     This study aims to ascertain the normal range of sodium in urine specimens collected from~     healthy newborn babies.~      It is believed that by increasing the level of salt in the intestine, glucose can be more~     easily be absorbed and therefore weight gain improved. Babies with conditions where they are~     at risk of salt depletion (i.e. those with a stoma) are currently administered oral sodium~     supplementation if they are failing to gain weight and have an associated 'low' urinary~     sodium level. Low levels of urinary sodium are considered to represent a state of low body~     sodium levels, as the kidneys attempt to reabsorb most of the sodium in the urine before it~     is excreted.~      Current practice varies widely as to the level below which treatment should be instigated.~     Some centres advise below 20 mmol/L (Birmingham Children's Hospital and Nottingham Children's~     Hospital guidelines), others below 10 mmol/L (University Children's Hospital, Zurich). In~     Glasgow, babies with poor weight gain are given sodium supplementation if urinary sodium~     levels are below 40 mmol/L. There are no documented ranges for the levels of urinary sodium~     in healthy, newborn babies.~      By determining the reference range of urinary sodium levels in healthy, term babies who are~     gaining weight appropriately, the investigators hope to be able to have a better~     understanding about both the level below which supplementation should be considered and the~     target range that should be aimed for.~   "
42060|NCT03016182|"~     During cardiac surgery with cardiopulmonary bypass , pulmonary dysfunction remains to be a~     problem complicating the postoperative course of the patients.Remote ischemic~     preconditioning(RIPC) with transient upper limb ischemia/reperfusion is a novel, simple,~     cost-free,non-pharmacological and non-invasive strategy.Recent several trials suggested that~     RIPC could provide pulmonary protection by reducing serum biomarkers,however,whether the RIPC~     can improve the clinical outcomes in patients undergoing on-pump cardiac surgery,is still~     uncertain.~      The study hypothesis is: remote ischemic preconditioning will provide lung-protective effect~     and improve clinical outcomes in patients undergoing cardic surgery.~   "
42061|NCT03016169|"~     The objective of this study is to evaluate the safety and performance of the Trifecta™ GT~     (Glide Technology) valve through 5 year follow-up in a prospective, multi-center, real-world~     setting. This study is intended to satisfy post-market clinical follow-up requirements of CE~     Mark in Europe.~   "
42062|NCT03016156|"~     This study seeks to determine whether a smartphone application called CRADLE (ComputeR~     Assisted Detection of LEukocoria) has the potential to improve the detection of leukocoria.~     There will be no impact on participants' health outcome.~      This study will be performed in two parts, each with a distinct cohort of patients.~      Part 1 will assess the feasibility of various techniques/conditions for using CRADLE within~     patients known to have leukocoria.~      Part 2 will estimate the sensitivity and specificity of CRADLE to detect leukocoria (using~     the techniques selected from information gathered in Part 1) as compared to an~     ophthalmoscope, within patients referred to the clinic for suspected leukocoria.~      PRIMARY OBJECTIVES:~        -  To determine the most effective usage of a camera phone application (CRADLE) to maximize~          detection of leukocoria in patients with retinoblastoma, congenital cataracts, and~          glaucoma.~        -  To estimate the sensitivity and specificity of a camera phone application (CRADLE) in~          detecting leukocoria.~   "
42063|NCT03016143|"~     The study is a single centre, phase II, double-blind, randomized, comparative trial that~     explored the immunogenicity and safety of single dose a allantoic split inactivated seasonal~     influenza vaccine and VAXIGRIP vacccine in healthy adults the two age groups (in persons 18~     to 60 years of age and older than 60 years).~   "
42064|NCT03016130|"~     This is an open-label, two-arm, phase III non-inferiority trial to evaluate the safety of a~     liberalized hospital diet inclusive of fresh fruits and vegetables to a neutropenic diet in~     patients with prolonged neutropenia. Both cohorts and diets will adhere to the hygiene and~     common sense advice listed in the FDA-endorsed food safety guidelines.~   "
42065|NCT03016117|"~     The study evaluate the anesthetic efficacy of Pecs II block II and parasternal block during~     quadrantectomy with or without axillary dissection, in breast cancer surgery~   "
42066|NCT03016104|"~     This trial attempts to evaluate the treatment efficacy of magnetic seizure therapy (MST) and~     its safety for bipolar mania. Half of the participants will receive MST, while the other half~     will receive electroconvulsive therapy (ECT).~   "
42067|NCT03016091|"~     A Phase II, Open-label, Single Arm Trial of Pembrolizumab for Refractory Atypical and~     Anaplastic Meningioma~   "
42068|NCT03016078|"~     The overall rationale for this investigation is to evaluate the clinical performance~     potential for Mepilex Border Post-Op Ag in the ability to minimize the risk of skin related~     post-operative wound complications such as blistering, maceration and redness at the incision~     and surrounding skin.~   "
42069|NCT03016065|"~     The purpose of this randomized, cross-over study is to explore the effects of pea hull fiber~     on bowel movement frequency, transit time, appetite, gastrointestinal symptoms, microbiota~     composition and activity.~   "
42070|NCT03016052|"~     this study examines the emergence of the visual mismatch negativity (vMMN) ERP component in~     response to deviations from the embedded contingency in attention bias modification treatment~     (ABMT) for social and generalized anxiety, and the interaction between vMMN emergence and~     clinical improvement.~      ***As of September 2017, recruitment of SAD participants has concluded.~   "
42071|NCT03016039|"~     To use curcumin supplementation as an additive treatment to induce clinical, biochemical~     response and remission in patients with suspected Pelvic inflammatory disease, Tubo ovarian~     abcess, Endometritis, wound infection.~      Hypothesis: An addition of oral curcumin to highly suspected PID/Endometritis/Wound infection~     patients may augment clinical and biochemical response and accelerates the improvements of~     the sign symptoms and reported outcomes of those diseases.~   "
42072|NCT03016026|"~     This study evaluates the safety and effectiveness of enhanced recovery after surgery(ERAS) on~     laparoscopic distal gastrectomy for gastric cancer.All of participants received an ERAS~     program.~   "
42079|NCT03015935|"~     Laparoscopic surgery has become very popular and standard in many indications after~     advancements of technique. Various methods have been used in first entry to the abdomen.~     Safety, wound size, to be not time-consuming, low cost, learning curve and efficacy are~     important. Several techniques, instruments, and approaches to minimize the risk of injury~     (the bowel, bladder, major abdominal vessels, and an anterior abdominal wall vessel) have~     been introduced.~      There is no consensus yet on an optimal method has yet emerged.~      The investigators aimed to evaluate efficacy of entry methods that ensures safe insertion of~     the first trocar at any site of the abdomen.~      To evaluate the efficacy of entry technique, the investigators used cohort of patients who~     will be planned to laparoscopic obesity surgery.~      Two methods are commonly used in surgical literature and in our center.~      The investigators have been used visible optical-entry technique in some patients for first~     entry and Veress technique in some other patients.~      For this purpose, the investigators designed an observational study.~   "
42080|NCT03015922|"~     This study will recruit patients currently receiving either lenalidomide or pomalidomide~     whose disease is relapsing. This is a dose escalation study and the aim is to determine the~     maximum tolerated dose (MTD) of REOLYSIN® that can be given in combination with lenalidomide~     or pomalidomide. The study will also investigate the safety, side effects and effectiveness~     of this treatment combination. Pomalidomide and lenalidomide will be evaluated separately as~     two separate groups.~   "
42081|NCT03015909|"~     The purpose of this study is to assess the ease of use, preference, and safety after 8 weeks~     subcutaneous administration of EutropinPen Inj. in patients pretreated with recombinant human~     growth hormone by reusable device.~   "
42082|NCT03015896|"~     This I/II trial studies the side effects and best dose of lenalidomide when given together~     with nivolumab and to see how well they work in treating patients with non-Hodgkin or Hodgkin~     lymphoma that has come back and does not respond to treatment. Monoclonal antibodies, such as~     nivolumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in~     chemotherapy, such as lenalidomide, work in different ways to stop the growth of tumor cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Giving nivolumab and lenalidomide may work better in treating patients with~     non-Hodgkin or Hodgkin lymphoma.~   "
42083|NCT03015883|"~     A unique approach for cancer treatment employing intratumoral diffusing alpha radiation~     emitter device.~   "
42084|NCT03015870|"~     Many detrimental effects of aging have been identified in the human voice, most of which are~     accepted as normal. However, age-related vocal deficits disrupt communication and decrease~     quality of life in older adults and may be preventable and/or treatable through behavioral~     interventions. The objective of this proposal is to determine the effectiveness of a~     technology-assisted vocal exercise intervention on the vocal function and quality of life in~     older adults. Forty older adults (65+) will be recruited and randomly assigned to either an~     app or PDF-delivered vocal training intervention lasting 8 weeks. Pre- and post-testing~     involving vocal functioning assessments, as well as mobility, psychosocial, and cognitive~     functioning assessments will be conducted. This interdisciplinary project will enhance the~     investigators understanding of physical, mental, and social health-related quality of life~     among older adults.~   "
42085|NCT03015857|"~     Hypotension following spinal anesthesia for cesarean section is a serious problem. In this~     study we investigated the effect of the vasopressors phenylephrine and noradrenaline on~     postspinal hypotension.~   "
42086|NCT03015844|"~     This is an expanded access protocol/compassionate use single institution study designed to~     determine the palliative benefit and toxicity of 131I-MIBG in patients with progressive~     neuroblastoma and metastatic pheochromocytoma who are not eligible for therapies of higher~     priority. Response rate, toxicity, and time to progression and death will be evaluated.~   "
42087|NCT03015831|"~     The prior End-AF study by the same group showed that 1 mg of colchicine didn't decrease the~     incidence of AF after cardiac surgery. The current study, End-AF Low Dose Study, will test~     0.5 mg colchicine vs. placebo in preventing AF after cardiac surgery.~   "
42088|NCT03015818|"~     Structural valve dysfunction (SVD) is the most common and life threatening complication in~     patients treated by aortic valve replacement. A calcification process is frequently involved~     in SVD but its pathophysiology remains unclear. In the hypothesis of an active metabolic~     phenomenon of calcification, as previously shown in native aortic valve stenosis, rather than~     a passive deposit of calcium in valve tissue, positon emission tomography (PET) imaging with~     18F-Fluoride could emphasize increased osteoblastic activity in SVD tissue.~      This study will include patients with echocardiography-confirmed SVD. Echocardiographic~     parameters and other current parameters analyzed in SVD patients such as bioprosthesis~     calcium scoring derived from CT will be compared to 18F-Fluoride activity.~   "
42089|NCT03015805|"~     The purpose of this study is to examine the effectiveness of Juvenile Probation Officers~     (JPOs) delivering Contingency Management (CM) to teens on their caseload who have problems~     with drug use. CM has already been shown to be effective at helping teens with drug problems~     but CM has never been delivered by JPOs. This study will test how well it works to have JPOs~     deliver CM during their regular meetings with teens.~   "
42090|NCT03015792|"~     This phase I/II trial studies the best dose and side effects of ibrutinib when given together~     with lenalidomide and dexamethasone and how well they work in treating patients with multiple~     myeloma that are not eligible for transplant. Ibrutinib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as~     lenalidomide and dexamethasone, work in different ways to stop the growth of tumor cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Giving ibrutinib, lenalidomide, and dexamethasone may work better in treating~     patients with multiple myeloma.~   "
42091|NCT03015779|"~     The aim of this trials investigates the therapeutic effects of application autologous oral~     mucosal epithelial cell sheets in the treatment of limbal stem cell deficiency disease.~   "
42092|NCT03015766|"~     Auricular acupressure therapy (AAT) has been applied in MHD patients with insomnia in recent~     years and yielded favorable results. However, the effect and safety of AAT for insomnia in~     MHD population still lacks high quality evidence. A randomized controlled clinical trial is~     planned to evaluate the effect and safety of AAT in MHD patients with insomnia.~   "
42094|NCT03015740|"~     The goal of this clinical research study is to find the highest tolerable or recommended dose~     of MGCD5 that can be given with nivolumab to patients with kidney cancer. Researchers also~     want to learn if this dose can help to control the disease. The safety of this drug~     combination will also be studied.~      This is an investigational study. MGCD516 is not FDA approved or commercially available. It~     is currently being used for research purposes only. Nivolumab is FDA approved and~     commercially available for the treatment of many types of cancer, including kidney cancer.~      The study doctor can explain how the study drugs are designed to work.~      Up to 60 participants will be enrolled in this study. All will take part at MD Anderson.~   "
42095|NCT03015727|"~     In this study, the investigators aim to compare the progression-free survival (PFS) and side~     effects of radiotherapy (RT) and concurrent chemoradiotherapy (CCRT) in locoregionally~     advanced nasopharyngeal carcinoma (NPC) patients with a satisfactory tumor response (complete~     response or partial response) after neoadjuvant chemotherapy (NACT).~   "
42096|NCT03015714|"~     Evaluation of the effectiveness of aquatic therapy for the treatment of freezing of gait in~     Parkinson's disease patients undergoing a multidisciplinary and intensive rehabilitation~     treatment.~   "
42097|NCT03015701|"~     To compare daily oral mifepristone vs placebo with respect to time to treatment failure in~     patients with unresectable meningioma.~   "
42098|NCT03015688|"~     It was previously proved an association of TGF-β1 and PDGF-BB with the pathogenesis of~     osteoarthritis (OA) by experiments of OA animal models. In this study, we aimed to determine~     whether serum concentrations of TGF-β1, PDGF-BB and CTX-1 were related to the knee OA. knee~     OA cases were collected from the first affiliated hospital of Shihezi university and healthy~     controls were recruited from the community. The severity of knee OA was defined as~     kellgren-lawrence (K-L) classification criteria.Serum levels of chemical biomarkers were~     compared between knee OA cases and controls or among K-L grade 2 to grade 4 groups. The serum~     concentrations of the TGF-β1, PDGF-BB and CTX-1 were determined by ELISA .~   "
42099|NCT03015675|"~     Linus Pauling and Dr Ewan Cameron have published two retrospective studies about using high~     dose vitamin C to treat cancer patients forty years ago. Their studies have shown that high~     dose vitamin C usage could significantly prolong overall survival of patients with advanced~     cancer. Recently, preclinical study has shown that human colorectal cancer cells harboring~     KRAS or BRAF mutations are selectively killed by high levels of ascorbic acid (AA). High dose~     of AA impairs tumor growth in Apc/KRASG12D mutant mice. Previous phaseⅠclinical trials have~     found that high dose (1.5g/kg or 90g/m2) iv AA is well tolerated in cancer patients. This~     protocol is a phase Ⅲ, study of ascorbic acid (AA) infusions combined with treatment with~     mFOLOX6 versus mFOLOX6 alone as first-line therapy in patients with recurrent or advanced~     gastric cancer.~   "
42100|NCT03015662|"~     Objectives: The purpose of the current randomized clinical trial is to compare the~     effectiveness of dry needling versus myofascial release therapy on myofascial trigger points~     (MTrPs) in cervical muscles, quality of life, fatigue, quality of sleep, anxiety and~     depression in patients with fibromyalgia syndrome (FMS).~   "
42101|NCT03015649|"~     The purpose of this study is to evaluate the performance of FDA-cleared SAVI SCOUT Breast~     Localization and Surgical Guidance System (SCOUT) over a longer duration prior to surgery.~     The device is a non-wire system, which uses nonradioactive light-activated radar, to provide~     breast surgeons with real-time guidance to locate and remove the target lesion in the breast~     and/or axillary tissue. The SCOUT device standard of care use is placement up to 30 days~     prior to surgery to assist surgeons in the localization and retrieval of breast/axillary~     lesions. Routine image-guided methods (Mammography, Ultrasound, and CT) are used. In this~     study, investigators will assess the longer term placement of the SCOUT device over an~     extended time (31 - 365 days) in order to address the needs of patients who require~     neoadjuvant treatment prior to definitive surgery.~   "
42102|NCT03015636|"~     Cognitive Behavioral Therapy (CBT) is treatment of choice for insomnia (CBT-i). Many patients~     in psychiatric care have sleep problems including insomnia, but are rarely given the choice~     to participate in CBT to improve their sleep. Patients with ADHD is a patient group with high~     levels of sleep difficulties. Sleep problems in this patient group can be both more general~     such as insomnia, but can also be related to the ADHD itself and to the use of ADHD~     medication. In a previous pilot study, the investigators developed a version of CBT-i that~     would target sleep problems in this population. The basis was CBT-i, but with more emphasis~     on sleep promoting behaviors specific to ADHD (e.g. appropriate timing of ADHD-medication),~     techniques that would also alleviate sleep phase problems, (e.g. the systematic use of light~     and darkness), and techniques to target more general sleep disturbing habits (e.g. not~     winding down before bed time), that are also common in patients with ADHD. This treatment was~     well tolerated and gave moderate effects on insomnia severity in the pilot study. In a~     naturalistic randomized controlled trial, the investigators now evaluate the effects of this~     psychological treatment on sleep and symptoms of ADHD in patients at the ADHD-clinics,~     Northern Stockholm Psychiatry, Sweden.~   "
42103|NCT03015623|"~     The purpose of this study is to assess the safety and tolerability of the investigational~     product, SBI-101, in subjects with Acute Kidney Injury (AKI). SBI-101 is a biologic/device~     combination product designed to regulate inflammation and promote repair of injured tissue~     using allogeneic human mesenchymal stromal cells. Patients will be randomized to receive one~     of three treatments, low dose SBI-101, high dose SBI-101, or sham control. SBI-101 will be~     integrated into the renal replacement circuit and patients will be treated for up to 24~     hours.~   "
42104|NCT03015610|"~     This study will evaluate the effect of CYP2C19 and ABCB1 genes on pharmacokinetics of~     lansoprazole in children with mild gastroesophageal reflux (GER) and uncontrolled asthma. It~     will determine if genotype-guided lansoprazole dosing of lansoprazole improves GER and asthma~     control.~   "
42105|NCT03015597|"~     The purpose of this study is to see whether contingency management (CM) can be successfully~     added as an adjunct treatment to standard stop smoking services in outpatients undergoing~     treatment for opiate addiction. Forty tobacco smoking patients undergoing treatment for~     opiate addiction will be stratified to a CM intervention for either smoking abstinence or~     attendance at the clinic, whilst also receiving usual stop smoking services cessation~     treatment. The intervention will run for five weeks and participants will be followed up six~     months after the beginning of the study.~   "
42108|NCT03015558|"~     The aim of this study is to evaluate, versus placebo, the analgesic efficacy of the~     opercular-insular cortex stimulation with Transcranial Direct Current Stimulation (tDCS), in~     both healthy subjects and chronic neuropathic pain patients. In healthy subjects analgesia by~     tDCS will be assessed using both laser stimuli and cold pressor test. In patients the~     assessment regards their chronic pain (ratings for ongoing, evoked and paroxysmal pain, sleep~     and fatigue). Opercular-insular stimulation is obtained via a combined 6-electrode montage~     and by bi-vestibular stimulation (since vestibular pathways reach the posterior insular~     cortex). In patients, three separate conditions (two active and one sham) will be tested in~     randomised order. In healthy subjects, two other conditions are added to control for~     attention and distraction confounders.~   "
42109|NCT03015545|"~     Whole body vibration is an exercise modality that could modulate tissue blood perfusion and~     neural reflexes, and thus may have the potential to alter muscle stiffness through modulation~     of contractile properties or/and neurological adaptation. However, the potential effects of~     WBV on leg muscle stiffness in stroke rehabilitation remains unknown. The overall aim is to~     investigate the effects of whole body vibration (WBV) on leg muscle stiffness and Hoffman~     reflex (H-reflex) and to identify the optimal vibration parameters that may reduce leg muscle~     stiffness among people with stroke.~   "
42110|NCT03015532|"~     This is a Phase 2b, randomized, double-blind, saline placebo- and active-controlled,~     multicenter study in subjects undergoing primary unilateral total knee arthroplasty (TKA) to~     evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of HTX-011 administered~     via infiltration to the surgical site.~   "
42111|NCT03015519|"~     The incidence of Type 2 Diabetes Mellitus (T2DM) is increasing day by day but the treatment~     options are limited in children and adolescents. Albiglutide, approved for the treatment of~     T2DM in adult population, is a novel analogue of glucagon-like peptide-1 (GLP-1) with a~     sufficiently long half-life to permit once a week injection. The study will be conducted in 2~     parts: Part A is a single dose pharmacokinetic (PK) study to confirm the dose and safety of~     albiglutide in pediatric subjects aged 10 to less than 18 years and Part B is a randomized~     double-blind placebo controlled study to evaluate the safety and efficacy (glycemic control)~     of albiglutide in the pediatric population. Treatment duration in Part B is 52 weeks (24~     weeks double-blind placebo-controlled and 28 weeks open-label during which all subjects will~     receive albiglutide). Approximately 210 eligible male and female subjects will be included in~     the study.~   "
42112|NCT03015506|"~     The objective of this study is to determine the glycemic index of 4 pulse-based breads in at~     least 10 normal healthy human volunteers. Participants will be studied in the morning on 6~     separate days after overnight fasts. On the first and last days they will consume a test meal~     consisting of about 2 slices of white bread (50g carbohydrate) and on the other 4 days they~     will consume 2-3 slices (50g carbohydrate) from 4 different test breads containing starch~     obtained from pulses (beans and/or lentils). Blood glucose will be measured at intervals over~     2 hours. Glycemic index is calculated as 0.71 times F/WB where F is the incremental area~     under the curve of blood glucose (AUC) after each test bread and WB is the mean AUC after~     white bread.~   "
42113|NCT03015493|"~     The purpose of the study is to examine the effects of cervical traction with or without the~     addition of neural mobilization, in patients with cervical radiculopathy~   "
42114|NCT03015480|"~     This pilot study tests the feasibility of remotely delivered medical nutrition therapy (MNT),~     focused on increasing fruit/vegetable intake, and decreasing sodium and red/processed meat~     intake, in the treatment of patients with stage 1-3a chronic kidney disease (CKD) and~     diabetes.~   "
42115|NCT03015467|"~     Severe acute pancreatitis is an acute and rapid progress of the digestive system disease.Most~     patients with severe pancreatitis associated with intestinal mucosal barrier~     dysfunction.Intestinal microflora,an important part of the intestinal mucosal barrier, play~     an important role in the development process in the course of severe acute pancreatitis. At~     this stage of the study that infection of pancreas and other organs is the leading cause of~     death in patients with severe acute pancreatitis，and the main pathogens from intestinal~     micro-organisms， but the intestinal flora changes did not be mentioned. Fecal Microbiota~     Transplantation that has been used for treatment of inflammatory bowel disease and~     Clostridium difficile infection may be a new technology for regulation of intestinal mucosal~     dysfunction and intestinal flora unbalance.~   "
42116|NCT03015454|"~     A sepsis early warning predictive algorithm, InSight, has been developed and validated on a~     large, diverse patient cohort. In this prospective study, the ability of InSight to predict~     severe sepsis patients is investigated. Specifically, InSight is compared with a well~     established severe sepsis detector in the UCSF electronic health record (EHR).~   "
42117|NCT03015441|"~     The purpose of this study is to assess the effect of a 28-day fermented milk product~     consumption twice daily on intestinal gas production of dihydrogen (H2) and methane (CH4) in~     healthy subjects high H2 producers.~   "
42118|NCT03015428|"~     This study aims to experimentally evaluate the training program for family caregivers of~     people with dementia_Living together with Dementia.~   "
42119|NCT03015415|"~     This study compares patients with post traumatic elbow stiffness and evaluate the range of~     motion improvement with two types of treatment: surgical release versus non-surgical~     rehabilitation protocol with orthoses.~   "
42120|NCT03015402|"~     The main objective of this study is to determine the clinical efficacy of oral inorganic~     nitrite verses placebo and the therapeutic response with regards to exercise tolerance in~     patients with pulmonary hypertension and heart failure with preserved ejection fraction~     (PH-HFpEF).~   "
42121|NCT03015389|"~     This is a multi-center, prospective, randomized study which will enroll patients undergoing~     endoscopic surveillance due to a history of histologically confirmed dysplasia. A member of~     the research team will approach a potential subject to discuss participation in the study,~     including background of the proposed study, inclusion and exclusion criteria, benefits and~     risks of the procedures and follow-up. If this is of interest to the subject, the informed~     consent form is discussed and presented. The subject must sign the consent form prior to~     enrollment. This form will have prior approval of the study site's Institutional Review Board~     (IRB). Failure to obtain informed consent renders the subject ineligible for the study.~   "
42122|NCT03015376|"~     Purpose: To investigate the prevalence of the germline mutations in the BRCA 1/2 and mismatch~     repair genes in patients with epithelial ovarian cancer (EOC) and their relatives, and~     related somatic mutations in tumor tissues in the northern part of china.~      Patients and methods: A multicenter prospective study will be hold in the northern part of~     china form 2017. About 1000 female patients with epithelial ovarian cancer and their~     ralatives will be tested for germline mutations in the BRCA 1/2 and mismatch repair genes and~     related somatic mutations in tumor tissues, regardless of the family history.~      Study type: Observational Official title: Prevalence study of germline mutations in~     susceptibility ovarian cancer genes in patients with epithelial ovarian cancer and somatic~     mutations in their tumor tissures in the northern part of china.~      Enrollment: 1000~   "
42123|NCT03015363|"~     The objective of the Cloud DX Pulsewave Health Monitor study is to prospectively calibrate~     and validate a novel, non-invasive wrist cuff blood pressure device against the gold standard~     for hemodynamic monitoring (intra-arterial pressure) in voluntarily consented patient~     participants who are scheduled for an elective cardiac catheterization procedure for~     clinically valid reasons.~   "
42124|NCT03015350|"~     16 patients with American Society of AnesthesioIogy (ASA) physical status I-III will~     recruited to this study. Patients will divided to the 2 groups. %1.5 Sevoflurane will apply~     in Group S and %6 Desflurane will apply in Group D. Each groups will divide 2 subgroups. Two~     lung ventilation will be performed to Group Sa and Group Da, one lung ventilation will be~     performed to Group Sb and Group Db. At the time point 40.minutes first blood sample will~     given from patients. Blood sample will be taken at intervals of 10 minutes from groups of two~     lung ventilation. In groups of one lung ventilation, blood samples will be taken at the time~     interval of 10 minutes after one lung ventilation started. All blood samples will be assess~     in Gas Chromatography.~   "
42125|NCT03015337|"~     This study examined how well elementary students demonstrated motor skill competency as a~     result of participating in the evidence-based quality physical education program and~     investigated relationships between levels of health-related physical fitness and physical~     activity in school-aged children.~   "
42126|NCT03015324|"~     Hydroxychloroquine will be administered on an outpatient basis within 12 weeks after primary~     surgery followed by adjuvant chemotherapy /or radiation therapy (if needed).~     Hydroxychloroquine will be administered orally at a dose of 400 mg daily for 90 days.~     Subjects will receive HCQ every day.~   "
42127|NCT03015311|"~     The Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients (STEP) is a~     2-arm, multi-center, prospective, randomized, open-labeled, blinded-endpoint trial. The~     purpose of this trial is to test whether a treatment program aimed at reducing systolic blood~     pressure (SBP) to a lower goal (<130 mmHg, intensive treatment) than currently recommended~     (<150 mmHg, standard treatment) will reduce CVD risk among persons between 60-80 years of~     old. Furthermore, this trial will also examine the effect of blood pressure APP management~     strategy via WeChat network on medication compliance, blood pressure control and CVD~     benefits.~   "
42128|NCT03015298|"~     The results of PET/MRI and PET/CT in each recruited gastric cancer patients will be compared.~   "
42129|NCT03015285|"~     Adults with high anxiety sensitivity (AS) and a mental health diagnosis of anxiety,~     depression, or posttraumatic stress will be recruited and will be randomly assigned to either~     transdiagnostic cognitive behavioural therapy (CBT) for AS or disorder-specific CBT for their~     primary mental health problem. The study outcomes - AS, anxiety, mood, and substance use~     symptoms, and functional impairment - will be assessed at pre-and post-treatment and 6 and 12~     months post-treatment via standardized self-report measures completed by participants and a~     standardized diagnostic interview.~   "
42130|NCT03015272|"~     The goal of the Novel Language Intervention for minimally verbal children with Autism~     Spectrum Disorder (ASD) is to test the efficacy of one experimental treatment (AMMT) compared~     to baseline assessments and compare the AMMT efficacy to a control intervention (SRT), both~     treatments were designed to facilitate speech output in minimally verbal 5.5 to 12.0 year~     olds. This study aims to compare the two interventions (one intonation-based; the other~     non-intonation-based) in a single-blind, randomized controlled trial (RCT) that includes a~     comprehensive baseline assessment battery, 25 intensive 1-on-1 treatment sessions conducted 5~     days/week, and a series of probe assessments administered at multiple timepoints pre-,~     during, and post-therapy.~      Despite the complex needs of minimally verbal children with ASD and the wide variety of~     treatments available to address many of those needs, there is still a great need for~     effective methods that promote the development of speech sounds and facilitate the production~     of those sounds in this growing population. While the primary aim of this RCT is to~     investigate the effects of AMMTversus a control intervention (SRT) on minimally verbal~     children with ASD and compare the two interventions to determine whether one is more~     effective than the other, this study also aims to examine whether baseline cognitive skills,~     speech praxis, joint attention abilities and/or neural architecture can predict the effects~     of treatment with AMMT or SRT in minimally verbal children with ASD.~   "
42131|NCT03015259|"~     A randomized multiple-dose, placebo-controlled, parallel group design consisting of a 2-week~     run-in period followed by a 6-week treatment period of the placebo, Test product (Budesonide~     80 mcg / Formoterol fumarate dihydrate 4.5 mcg), or Reference product Symbicort® inhalation~     aerosol.~   "
42132|NCT03015246|"~     This research deals with behaviors that are part of opioid dependence. The purpose is to~     study how stress and medication dose can affect opioid drug use.~   "
42133|NCT03015233|"~     Abdominal pain is one of the most common reasons for consultation in Emergency Departments~     (ED) worldwide. The challenge for physicians is to not misdiagnose a surgical emergency. The~     actual gold standard for diagnosis is computed tomography (CT). However with this procedure~     there is high radiation exposure and a risk factor of radiation-induced cancers, therefore~     alternative diagnostic techniques should be considered. The aim of this study is to evaluate~     the performance of measuring venous lactate in patients presenting with acute abdominal pain~     in ED.~      In this single-center, prospective, non-interventional study, the diagnostic accuracy of~     venous lactate in order to detect surgical emergencies is evaluated. The hypothesis made here~     is that venous lactatemia is a positive predictive factor of surgical emergencies in patients~     with acute abdominal pain.~   "
42136|NCT03015194|"~     Background:~      Transcatheter mitral valve replacement (TMVR) is recommended for some people with heart~     problems. But the usual TMVR techniques might cause an obstruction for some people. A new~     technique is called LAMPOON. It may have less risk of obstruction. Participants in this study~     will be among the first in the world to have this technique done.~      Objectives:~      To test the safety and effectiveness of the LAMPOON technique in TMVR.~      Eligibility:~      Adults ages 21 and over who are recommended to have TMVR with LAMPOON~      Design:~      Participants will be screened with medical history and exam and by review of medical records.~      Participants will have blood tests, a scan, and a heart test before the procedure.~      Participants will have TMVR with LAMPOON. They will have anesthesia. Doctors will use a wire~     to split the diseased mitral valve and move it out of the way. They will replace a heart~     valve.~      Participants will stay in the hospital for about 1 month.~      They will repeat the previous tests before leaving the hospital, 1 month later, and 1 year~     later.~      They will have yearly follow-up phone calls for about 5 years.~      In the event of a participant's death, researchers will ask for an autopsy and to analyze the~     heart. Permission for this is not required as part of the study.~   "
42137|NCT03015181|"~     Background:~      Human immunodeficiency virus (HIV) is a global health threat. The body uses antibodies to~     fight infection. VRC07-523LS is an antibody directed against HIV. It may be used to prevent~     mother-to-child transmission of HIV. It may also prevent sexual transmission of HIV and treat~     HIV-1 infected people.~      Objective:~      To test the safety, tolerability, dose, and pharmacokinetics of VRC07-523LS in healthy~     adults.~      Eligibility:~      Healthy people ages 18-50~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Blood and urine tests~      Participants will be assigned to 1 of 7 groups:~      Groups 1-5 will get the drug at 1 visit and then be observed for 24 weeks.~      Groups 6 and 7 will get the drug at 1 visit every 12 weeks, for a total of 3 doses over 48~     weeks.~      Participants will get the drug in 1 of 2 ways:~      Infusion into a vein over at least 30 minutes. Participants will have blood tests 1, 3, and 6~     hours after the infusion. They will have 1-3 visits during that week. Those in Group 7 will~     have 4-5 visits in the week after their second and third doses.~      Injection into the fatty tissue under the skin. Participants will have blood tests before the~     injection. They will have 1-3 visits during that week. Those in Group 6 will have 4-5 visits~     after the second and third doses.~      Visits include:~      Physical exam~      Blood and urine tests~      Optional oral swabs to collect saliva~      Participants will keep a diary of their temperature and symptoms for 3 days after each dose.~   "
42138|NCT03015168|"~     We explored the relationship between NLR and grade 3 or higher treatment related small bowel~     toxicity and treatment outcome of patients with rectal cancer undergoing capecitabine and~     concurrent intensity modulated radiotherapy (IMRT).~   "
42139|NCT03015155|"~     Recent clinical studies have shown that systemic therapeutic hypothermia improving the~     outcomes in patients with ST segment elevated myocardial infarction (STEMI) received primary~     percutaneous coronary intervention (P-PCI).Likewise, a few in vivo animal experiments have~     described the methods, mechanism and rationale of therapeutic hypothermia, including local~     myocardial hypothermia. However, little is known of the local myocardial hypothermia having~     impact on prognosis of the patients with acute myocardial infarction. The aim of this study~     is to ascertain whether local myocardial hypothermia is effective in treatment of~     ischemia/reperfusion injury in patients with STEMI undergoing P-PCI.~   "
42140|NCT03015142|"~     There is a clear need in spine surgery to place pedicle screws in the right place in the~     spine with good accuracy to avoid damage to important structures (spinal cord, nerve roots or~     vertebral arteries). The objective of the study is to investigate the accuracy of screw~     placement during spine surgery.~   "
42141|NCT03015129|"~     This study will test the safety and efficacy of the experimental drug called durvalumab with~     or without another experimental drug called tremelimumab in endometrial cancer.~   "
42142|NCT03015116|"~     BACKGROUND: Plantar fasciitis, a degenerative injury of the connective tissue in the foot,~     results in pain-related disability in Service Members and beneficiaries and contributes to~     decreased physical activity and excessive healthcare costs. Even if effective, current~     treatment protocols may require 6-12 months of therapy to return individuals to pain-free~     activity. Photobiomodulation (PBM), or low level laser therapy, uses non-ionizing light to~     elicit biological changes in tissues resulting in beneficial therapeutic outcomes. Evidence~     supports use of PBM for other degenerative connective tissue conditions, such as Achilles~     tendinopathy and epicondylitis. Unfortunately, previous studies of PBM for treatment of~     plantar fasciitis lack optimized treatment parameters and therefore have been inconclusive on~     its clinical effectiveness.~      SPECIFIC AIMS: 1. Establish feasibility of and adherence to a photobiomodulation protocol in~     conjunction with and compared to usual care for plantar fasciitis treatment. 2. Assess the~     clinical effectiveness of photobiomodulation in conjunction with and compared to usual care~     to improve function and decrease pain and in patients. 3. Assess the difference between two~     photobiomodulation dose parameters in conjunction with and compared to usual care for plantar~     fasciitis treatment.~      DESIGN: The investigators will use a prospective randomized controlled trial to meet the aims~     of this exploratory study. METHOD: A sample of 114 military healthcare beneficiaries will be~     randomly assigned to either usual care, usual care plus PBM lower dose, or usual care plus~     PBM higher dose groups. At baseline, during the treatment protocol, and at long term (3 and 6~     month) follow-up, measures of foot function and pain will be collected for analysis. The~     proposed methods will allow the study team to establish if PBM accelerates recovery compared~     to usual care, as well as determining the optimal dose for future trials comparing PBM to~     other, more invasive, therapies for plantar fasciitis.~   "
42143|NCT03015103|"~     The purpose of this study is to prove the product tested does not cause photoirritation or~     photosensitization reactions when exposed to sun light.~   "
42144|NCT03015090|"~     The aim of this study is to determine whether common CYP1A2 gene polymorphisms effect~     metabolism of theophylline in Han and Uygur Patients with chronic obstructive pulmonary~     disease patients.~   "
42156|NCT03014934|"~     Via a prospective non-interventional study clinical outcome of patients with - and without -~     history of pre-existing invasive aspergillosis undergoing allo-HSCT will be assessed, in~     terms of non-relapse mortality overall mortality and fungal infectious morbidity.~      Aim. Assessment of 1-year outcome of patients undergoing allo-HSCT with history of~     pre-existing IA vs. no pre-existing IA.~      Hypothesis. NRM in patients with pre-existing IA is not higher (by a specified margin of 10%)~     than patients without pre-existing IA.~      Study population. First allo-HSCT in patients with acute leukaemia and MDS given stem cell~     grafts.~      Cohort 1: History of probable or proven invasive aspergillosis Cohort 2: No History of~     probable or proven invasive aspergillosis: this cohort includes also the patient with a~     history of possible mycosis not documented microbiologically.~   "
42145|NCT03015077|"~     The rapidly increasing mortality and incidence of oral cancer has become a public health~     major problem in Taiwan. To date, the treatment of head and neck cancer mainly include~     surgery, radiotherapy and chemotherapy. However, radiotherapy and chemotherapy might have an~     influence on the patients' diet by causing dismal side effects, including nausea, vomiting,~     pain, infection, dysorexia, allotriogeustia, oral ulceration and dysphagia, which make the~     patients more difficult to absorb nutrients. In the previous study, the incidence of~     malnutrition among the patients with cancer has been estimated at between 40 and 80%,~     especially occurred in the patients with head and neck cancers and upper gastrointestinal~     cancers.~      In this study, the effect of supplement with L-Glutamine on the nutritional status and~     radiation-induced toxicity of head and neck cancer patients will be evaluated to improve the~     patients' quality of life when they are undergoing radiotherapy. When the head and neck~     cancer patients undergoing radiotherapy, patients' instructions and nutrient intervention of~     L-Glutamine are performed to maintain the patients' nutritional status and reduce the~     patients' diet-related or other side effects caused by radiotherapy. It is anticipated that~     head and neck cancer patients with surgery and radiotherapy intake with L-Glutamine might~     decrease treatment-related side effects and hence improve their quality of life when they are~     undergoing radiotherapy.~   "
42146|NCT03015064|"~     Prospective cohort evaluating patients in the State of Santa Catarina (Brazil) with the~     diagnosis of the first acute myocardial infarction from July 2016 until December 2020.~   "
42147|NCT03015051|"~     Bronchiolitis is the most common respiratory infection of the lower respiratory tract that~     affects 11-12% of infants in their first year of life. Approximately 1-2% of patients with~     bronchiolitis require hospital admission because of poor feeding and/or breathing~     difficulties. The standard treatment for bronchiolitis is represented by oxygen-therapy and~     hydration while neither steroids nor epinephrine nor bronchodilators are recommended. One of~     the techniques of administration of oxygen in bronchiolitis is represented by the high flow~     (HFNC) or by a system in which oxygen is delivered to 2L/kg through nasal cannulas. The HFNC~     provides humidification, heating and oxygen, ensuring a minimum positive pressure, reduces~     breathing load and allows for better nutrition. The main aim of therapy with high flows is to~     reduce the days of oxygen therapy and the cases of intubation. However, up to now, there have~     been few studies on the use of HFNC in Pediatric Emergency Units. The Cochrane review on this~     topic, updated in May 2013, included only one randomized controlled trial (RCT) on a pilot~     study of 19 subjects comparing HFNC with oxygen administered via head box. The oxygen~     saturation was higher in children HFNC after 8 (00% versus 96%, p=0.04) and 12 hours (99% vs~     96%, p=0.04) but similar in both groups at 24 hours. The authors concluded that the available~     evidence is insufficient to determine the effectiveness of HFNC.~      The aim of this study is to evaluate in a large number of cases the effectiveness of~     treatment with high flow versus standard treatment, in children with bronchiolitis referred~     to a Pediatric Emergency Department.~   "
42148|NCT03015038|"~     Duration of each part of the study per patient:~        -  Screening: From 1 to 4 weeks~        -  Sampling period (blood and tissue): 1 day~        -  Follow-up by patient: 60 months~        -  Total study duration by patient: 84 months~        -  Total inclusion duration: 24 months~        -  Total Follow-up duration: 60 months~        -  Total study duration: 84 months~   "
42149|NCT03015025|"~     The use of coumarins has been a challenge for doctors because of its narrow therapeutic range~     and they show great inter and intra-individual variability in the dose necessary to achieve~     an international normalized ratio (INR) within the therapeutic range. Among the factors~     influencing the interindividual variability in the dose required include age, weight, Vitamin~     K in the diet, comorbidity as well as drug interactions and in recent years has also seen the~     importance of pharmacogenetic factors.~   "
42150|NCT03015012|"~     The investigators hypothesize that compared to the provision of population-based lifestyle~     advice, providing DNA-based lifestyle advice via personalized nutrigenomics testing (PNT) to~     two distinct patient populations (Family Health Team patients receiving a lifestyle~     counselling intervention and transplant recipients) will lead to greater reductions in~     percent body fat. In addition, it will motivate them to adopt healthier dietary and physical~     activity habits through changes in attitudes and/or subjective norms and/or behavioural~     control, lead to greater fat loss (kg), increased percent lean mass and therefore improve~     health and quality of life outcomes for both patient populations. In addition, it is~     hypothesized that dietary strategies related to the intake of one or more dietary components~     of interest will mitigate post-transplant weight gain associated with three SNPs of interest.~      This is a randomized clinical intervention trial involving a total of four groups of patients~     (n = 400). The two main patient groups include overweight or obese, stable transplant~     recipients and overweight or obese patients who are attending group counselling sessions at~     the East Elgin Family Health Team. Within these two main groups, there will be two~     sub-groups. Patients will be randomized to receive either PNT or standard nutrition~     intervention (SNI). Baseline data will be conducted consisting of a food frequency~     questionnaire and three-day food records using a validated multiple pass method.~     Bioelectrical Impedance Analysis (BIA) will be conducted to assess body composition and to~     derive percent body fat and lean mass. Weight and height will be measured using a weigh scale~     and stadiometer. Attitudes, subjective norms and behavioural control will be assessed using a~     Theory of Planned Behaviour Questionnaire. Those patients randomized to the PNT group will be~     instructed on a tailored nutrition care plan and physical activity recommendations based on~     their individual genetic profile. At the same time, the SNI group will be instructed on~     general nutrition and physical activity recommendations for weight loss, which include the~     use of dietary strategies from the standard tool ('Just the Basics') used by registered~     dietitians for transplant patients and the GLB program for patients attending the East Elgin~     Family Health Team sessions. Monthly email reminders or phone calls (depending on patient~     preference) will be sent to transplant recipients as a reminder of their nutrition and~     physical activity plan. Reminders of nutrition and physical activity goals for the Family~     Health Team participants are incorporated into the GLB program. Three months, six months and~     twelve months after baseline data collection and individual nutrition interventions, baseline~     data will be repeated. After the study is complete, participants in the SNI group will be~     offered a nutrigenomics report and consultation with a registered dietitian.~      A paired t-test or repeated measures ANOVA will be used to assess within group change from~     baseline to each follow-up time point for: BMI, body fat, lean mass, and dietary intake. A~     repeated measures ANOVA will be used to test between group differences from baseline to each~     follow-up time point for: BMI, body fat, lean mass, and dietary intake. If significant mean~     differences are detected, a Tukey's post hoc test will be used to compare differences by~     group. Statistical significance will be determined by P < 0.05. General linear regression~     models will be used to assess interactions between each genotype of interest and each dietary~     component of interest on BMI and body composition from baseline to each follow-up time point.~   "
42151|NCT03014999|"~     A crossover trial with spinal cord injury volunteers will be conducted. Three sessions will~     be performed once a week in a counterbalanced order and at least with seven days washout~     period to minimize carry-over effects. In each session, volunteers will be submitted to~     quantity and quality of sleep, type of eating, fatigue and motivation level, Ashworth scale~     spasticity, cortical brain activity measures through simple pulse transcranial magnetic~     stimulation (pTMS), spinal cord activity measures through electrical stimulation and~     non-invasive brain stimulation (rTMS)~   "
42152|NCT03014986|"~     The availability of novel therapies with DAAs might prompt clinicians caring for HSCT~     recipients with HCV infection to prescribe the treatment more frequently and possibly earlier~     after HSCT. Since numerous possible therapeutic combinations exist, the choice of the most~     appropriate one is not straightforward. It depends not only on its efficacy, toxicity and~     rate of pharmacological interactions, but also on availability (both through healthcare~     system and in expanded access programs), and cost.~      This observational prospective study will focus on treatment strategies in HSCT recipients~     with HCV infection. The main focus will be the therapeutic approach, the combination of drugs~     chosen, the length of treatment and the outcome. The main reasons for treating or not~     treating HSCT recipients with HCV infection will be also explored. Compared to previous~     cohorts, this study might provide additional data in the area of non-invasive assessment of~     fibrosis, HCV-RNA levels and genotyping.~      In order to get as much data as possible on HCV treatment, patients with chronic HCV~     infection transplanted during the last 10 years will be included.~      Finally the prevalence of HCV-RNA positive patients among those transplanted in the year 2016~     will be reported.~   "
42153|NCT03014973|"~     The main objective of the study is to determine the intra-prostatic concentration of sexual~     steroids when castration resistance appears in castration-resistant prostate cancer patients~     compared to patients naif of hormonal treatment~   "
42154|NCT03014960|"~     The purpose of the study is to investigate the effects of sleep improvement in leaders on~     leader outcomes.~   "
42155|NCT03014947|"~     This is a phase I, randomized, double-blind, parallel-group trial to compare Investigation~     Medicinal Product (IMP) MSB11022, US- Reference Product (RP), and EU- Reference Medicinal~     Product (RMP) (Humira®) in healthy subjects.~   "
42157|NCT03014921|"~     This trial study and compare in blood and urinary matrices the impact of an iron injection on~     proteins involved in iron metabolism during a blood donation. The goal is to study the impact~     of an iron injection on detection markers of a blood donation in the anti-doping field~   "
42160|NCT03014882|"~     Accumulation of iron in patients with beta thalassemia major causes free radical formation~     which leads to damage of biological membranes. Sperm DNA damage may result from these~     generated antioxidants.~      We aimed at investigating the current DNA damage in the sperms of adult patients with beta~     thalassemia major and the effect generated by giving antioxidant treatment for 6 months.~   "
42161|NCT03014869|"~     For moderate AECOPD(pH<7.35), several guidelines have strongly recommended NPPV as standard~     therapy, which can reduce the rate of intubation and mortality. A few previous studies have~     shown that HFNC can efficiently improve alveoli ventilation and breathing pattern in some~     severe AECOPD patients. Therefore, we hypothesize that HFNC is not inferior to NPPV for~     preventing endotracheal intubation in moderate AECOPD patients. To assess this hypothesis, we~     performed a multicenter, randomized, noninferiority trial of HFNV vs NPPV in moderate AECOPD~     patients.~   "
42162|NCT03014856|"~     This study provides a sound basis towards a better understanding of the biochemical~     mechanisms behind childhood obesity and its metabolic phenotypes, which will be of great~     importance towards the development of more personalized prevention and treatment in future.~   "
42163|NCT03014843|"~     The aim of this study was to investigate the effect of naloxone (IV or IM administration) and~     methylnaltrexone (subcutaneous administration) on esophageal sensitivity, in a group of~     healthy volunteers in order to evaluate the role of endogenous opiods in symptom perception~     in gastro-esophageal reflux disease. Esophageal sensitivity was assessed by using a~     multimodal esophageal stimulation protocol where sensitivity to thermal, mechanical,~     electrical and chemical stimulation was tested.~   "
42164|NCT03014830|"~     Alirocumab is an injectable treatment for elevated blood cholesterol. The hypothesis of this~     study is that it also increases cholesterol excretion from the body into the stool, a process~     sometimes called reverse cholesterol transport. A cholesterol metabolic study will be done~     before and after 6 weeks of alirocumab treatment. If alirocumab increases reverse cholesterol~     transport, it is possible that this action provides additional protection from cardiovascular~     disease.~   "
42165|NCT03014817|"~     The present study aims at analyzing whether ultrasonic tissue coagulation dissection~     technique offers a smoother peri- and postoperative course and reduces the risk for~     conversion from laparoscopic to open surgery in acute cholecystectomy patients as compared to~     electrocautery in case of acute cholecystitis The study is performed as a double-blinded~     study on patients undergoing laparoscopic surgery for acute cholecystitis. Patients included~     in the study are randomized to surgery with either the traditional electrocautery based~     technique or ultrasonic scalpel based dissection.~   "
42166|NCT03014804|"~     This phase II trial studies the side effects of autologous dendritic cells pulsed with tumor~     lysate antigen vaccine and nivolumab and to see how well they work in treating patients with~     glioblastoma that has come back. Vaccines made from a person's tumor cells may help the body~     build an effective immune response to kill tumor cells. Monoclonal antibodies, such as~     nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving dendritic~     cell-autologous lung tumor vaccine and nivolumab may work better in treating patients with~     glioblastoma.~   "
42167|NCT03014791|"~     Hypertension, also known as high blood pressure, is a chronic medical condition, in which the~     blood pressure is elevated. This is a common condition, which can lead to severe~     complications such as cardiovascular disease, heart attack, stroke and kidney disease, if not~     detected and treated early.~      Accumulating evidence suggests that the incidence of hypertension varies according to age,~     ethnicity and obesity. In order to obtain an in-depth knowledge of the pathophysiological~     mechanisms of hypertension, we aim to investigate the haemodynamic and biochemical correlates~     of elevated blood pressure across the adult age-span, and determine the extent to which body~     size and ethnicity impact on these associations. We also wish to investigate the impact of~     hypertension on key target organs (end-organ damage). The primary objective of this study is~     to compare the mechanisms regulating blood pressure in hypertensive and non-hypertensive~     participants across the adult age span, and to assess the influence of body mass index and~     ethnic background on these mechanisms. Secondary objectives are to investigate the~     association between blood pressure and cardiovascular physiology across the adult age span at~     rest and during sub-maximal exercise and to investigate the impact of blood pressure~     haemodynamics on key organs including the arteries and heart by assessing end-organ damage~     such as endothelial function, arterial structure and left ventricular mass/function.~      This study will be a combined case-control and cross-sectional study describing the~     procedures and time commitment required to investigate our scientific aims. This is a single~     centre study that will be conducted in a secondary care environment. Both male and females~     aged 18 and over and that are able provide informed consent will be considered for this~     study. People who are pregnant, currently receiving dialysis, illness with a life expectancy~     <1 year, current active malignancy and cannot provide informed consent are ineligible for~     this study. The study will be open for five years and each patient will complete a maximum of~     four visits in a 12 month period. Participants will complete a variety of non-invasive~     physiological assessments of their cardiovascular system and lung function. There will be~     some minimally invasive procedures completed, including a blood test and assessment of small~     artery endothelial function which involves insertion of a small needle under local~     anesthetic.~   "
42168|NCT03014778|"~     This study is necessary in order to provide proof the effectiveness of Chlorhexidine~     gluconate and its safety.~   "
42169|NCT03014765|"~     Study will enroll patients scheduled for hip arthroplasty. In each subject a flow-mediated~     dilatation capability (FMD) of the brachial artery will be measured prior to elective~     surgery, within 24 hours after surgery and 5-7 days after surgery. At each session the~     brachial artery diameter will be measured at rest, during cuff inflation and 50 seconds after~     cuff deflation. From above mentioned values the increase in the diameter of the artery during~     reactive hyperemia will be calculated.~      Simultaneously with the ultrasound investigations, the blood for determination of the~     endothelial dysfunction markers will be collected.~      The participants will be contacted again 3 months after the surgery and asked about the~     complications which may be associated with the surgery.~   "
42170|NCT03014752|"~     Epilepsy is one of a common neurological disorder. Antiepileptic drugs (AEDs) are usually the~     primary treatment of epilepsy. However, almost 30% of patients do not respond to AEDs and~     other treatments including ketogenic diet (KD) are used. The Ketogenic Diet (KD) is a~     low-carbohydrate, high fat, adequate-protein diet. In this study, investigators are going to~     compare two kinds of the ketogenic diet namely classical ketogenic diet and modified Atkins~     diet. Fifty children and adolescents with intractable epilepsy will be included, 25 patients~     in each group, and will receive the diet for three months on non-randomised basis. In the~     classical ketogenic diet, the diet with a ratio of 4 to 1 (4:1), each 4 grams of fat to each~     gram of carbohydrate plus protein, will be introduced. Classical ketogenic diet will be~     established on outpatient setting, without fasting and gradually. The modified Atkins diet~     will be applied by the ratio of 1:1 or 2:1, each 1 or 2 grams of fat to each gram of~     carbohydrate plus protein.~   "
42171|NCT03014739|"~     Achilles tendon plays a significant role in walking and sporting activities, particularly~     through ankle joint and lower limbs stability. Ultrasound imaging can be the first-line~     examination of choice for patients suspected of having Achilles tendon injury, which is more~     and more frequent. Nowadays, ultrasound elastography can be used to evaluate the~     viscoelasticity properties of Achilles tendon, however little is known about the~     reproducibility of the technique. This study aims to evaluate the reproducibility of~     supersonic shear imaging SWE™ Young's modulus measurements of shear wave velocity (m/s) in~     Achilles tendon and plantar fascia.~   "
42172|NCT03014726|"~     Robust I study is a feasibility study about safety and efficacy of DCB.~   "
42173|NCT03014713|"~     The purpose of this study is to explore the effectiveness of dexmedetomidine as an adjunctive~     analgesic, combined with dezocine and flubiprofen, used in intravenous Patient-Controlled~     Analgesia (PCA) after open colorectal surgery.~   "
42174|NCT03014700|"~     One of the most common hemostatic derangements in pediatric open- heart surgery is an acute~     acquired hypofibrinogenemia. This compromises fibrin clot generation and platelet~     aggregation, resulting in increased bleeding and allogenic blood transfusions.~      Currently, fresh frozen plasma and cryoprecipitate are used to supplement fibrinogen in~     pediatric cardiac patients. We propose that replacing cryoprecipitate with fibrinogen~     concentrate will be as effective in treating post-CPB bleeding and will decrease total blood~     product exposure when used as part of a blood transfusion algorithm.~      We plan to include all patients undergoing cardiac surgery on CPB less than 12 months and a~     fibrinogen level <250mg/dL while on bypass.~      We hope to demonstrate that fibrinogen concentrate is at least as effective as the standard~     of care in the management of peri- operative bleeding in neonatal patients undergoing~     cardiopulmonary bypass. If we are able to demonstrate that fibrinogen is at least as~     effective as the standard of care, then we would plan a multi-center trial to demonstrate the~     safety and efficacy of this medication. If we are able to demonstrate that fibrinogen~     concentrate is effective, fibrinogen concentrate could replace allogenic products and~     potentially decrease transfusion related morbidity in mortality in this population.~   "
42175|NCT03014687|"~     To find out whether oral antibiotics given after transsphenoidal endoscopic surgery for~     pituitary adenoma improves sinus and nasal symptoms, reduces the incidence of infection~     (sinusitis), and helps mucosal healing in the nasal passages.~   "
42176|NCT03014674|"~     Mepolizumab (SB-240563) is a humanized monoclonal antibody (Immunoglobulin G1, kappa, mAb)~     that blocks human interleukin-5 (hIL-5) from binding to the interleukin (IL)-5 receptor~     complex expressed on the eosinophil cell surface and thus inhibits signaling. This study will~     compare the pharmacokinetics and safety of mepolizumab administered as a liquid drug product~     in two different devices with the reconstituted lyophilized drug product in healthy subjects.~     Subjects will receive a single administration of 100 milligram (mg) mepolizumab as a single~     injection. The randomization will be stratified by body weight (<70 kilogram (kg), 70 <80 kg~     and >=80 kg) and the site of injection will be randomized 1:1:1 to the upper arm, abdomen or~     thigh. Approximately 243 healthy subjects will be randomized so that at least 9 subjects are~     randomized to each mepolizumab treatment within each weight strata and 3 subjects within each~     mepolizumab treatment, weight strata and injection site. Each subject will participate in the~     study for up to approximately 16 weeks (up to 85 days after drug administration), and will~     have a screening visit, a single dose treatment period, and a follow-up visit.~   "
42177|NCT03014661|"~     Questionnaire to measure and control the quality of life of patients with hay fever who are~     treated or were treated with Pollinex quattro~   "
42178|NCT03014648|"~     This is a phase II clinical trial aimed at evaluating the efficacy of PD-L1 inhibition with~     atezolizumab in advanced squamous and non-squamous NSCLC patients previously treated with~     anti-PD-1 therapy with either nivolumab or pembrolizumab.~      In order to account for the variability of response kinetics to PD-1 directed therapy,~     patients will be enrolled in 3 parallel cohorts based on the best overall response to PD-1~     directed therapy.~        -  Cohort 1 (progressive disease)~        -  Cohort 2 (stable disease with minimum 12 weeks of therapy)~        -  Cohort 3 (partial to complete response followed by progressive disease)~   "
42179|NCT03014635|"~     This is a safety and efficacy study of DaxibotulinumtoxinA for Injection to treat moderate to~     severe frown lines.~   "
42180|NCT03014622|"~     This is a safety and efficacy study of DaxibotulinumtoxinA for Injection to treat moderate to~     severe frown lines.~   "
42181|NCT03014609|"~     The principal objective of the study is to measure parameters of inflammation, oxidative~     stress, and vascular, respiratory, and peripheral muscle function parameters, and identify~     parameters indicative of evolving cardiovascular risk (CVR) in COPD patients, using~     multivariate analysis.~   "
42182|NCT03014596|"~     Procedures for systematic user involvement in primary mental health services are lacking, and~     several adolescents are dissatisfied with their opportunities to influence the service~     provided. The research on the effects of user involvement is scarce, especially regarding~     user involvement for children and adolescents. Hence, we suggest introducing an idiographic~     assessment tool in a selection of Norwegian primary mental health services. Idiographic~     assessment is a way of measuring psychological constructs, by using tools specifically~     adapted for each individual respondent.~      This protocol describes the implementation and evaluation of a user involvement tool called~     'Assert', in Norwegian primary mental health services. Assert is a simple tool where the~     adolescents themselves decide the goals or themes that they would like to address in~     collaboration with their service provider. Assert is scored each time the adolescent and the~     service provider meet, to monitor progress toward the goal. A randomised controlled trial~     design is proposed for this study. Assert will be implemented in 5-10 Norwegian~     municipalities, and will include 250 participants between 12 and 23 years. The objective of~     the study is to examine the relationship between Assert and perceived user involvement. Are~     idiographic measures an adequate way to operationalise user involvement on an individual~     level? And if so, can user involvement (i.e. Assert) have an effect on quality of life and~     mental health in adolescents? And lastly qualitative analyses of the adolescents' themes and~     goals will be conducted to explore what matters to the adolescents that visit primary mental~     health services in Norwegian municipalities.~   "
42183|NCT03014583|"~     Chronic Back and/or Leg Pain (CBLP) after spinal surgical procedures, a condition commonly~     labelled Failed Back Surgery Syndrome (FBSS), affects between 15% and 40% of patients after a~     spine surgery. Treatment of this chronic condition by further operation or medical management~     has a heavy financial impact on health care systems.~      Many studies have demonstrated the efficacy and economic value of Spinal Cord Stimulation~     (SCS) for chronic neuropathic pain, and randomized controlled trials (RCTs) have shown SCS to~     be a clinically effective adjunct to medical management. SCS has the advantages of being~     reversible and less invasive than surgery and may cause fewer issues over time than long-term~     pharmacological treatments.~      Despite variable levels of success in the literature, approximately 30-55% of the patients~     treated with traditional SCS for neuropathic pain disorders will not receive adequate long~     term pain relief. Therefore, technical SCS system refinements, as well as new techniques have~     emerged.~      Two new stimulation waveforms based on traditional SCS technology have appeared to further~     optimize the outcome for specific painful conditions;~        -  Burst stimulation mode: which generates constant-current stimuli with 5 spikes at 500 Hz~          per burst and pulse width and interspike intervals of 1 ms.~        -  High-frequency stimulation (from 1 to 10 kHz) mode.~      Several studies have demonstrated the potential interest of these 2 new waveforms to treat~     FBSS patients compared to traditional SCS.~      The Precision Spectra™ system allows MultiWave Technology by offering a broad spectrum of~     waveform options (from Tonic Conventional Stimulation (TCS), BURST stimulation to High~     Frequency stimulation (HF)).~      To date, literature data comparing these 3 stimulation patterns is lacking but it is~     suggested the pain relief in some of non-responsive patients can be recaptured by~     increasing the SCS frequency to 500 Hz by BURST stimulation or beyond by HF stimulation. It~     seems important to conduct RCT in crossover, thanks to the new Precision SCS Stimulator, to~     compare the effects of these 3 different SCS modalities in FBSS patients and to determine~     which concept is the most effective in terms of pain reduction and energy consumption.~   "
42184|NCT03014570|"~     This pragmatic trial focuses on implementation of an evidence based process to increase~     person-centered management of behavioral and psychological symptoms of dementia (BPSD) in~     nursing homes, referred to as EIT-4-BPSD. The findings from this study will add to what is~     known about implementation of effective interventions in nursing homes, will serve as a model~     for other programs and care approaches, and will help facilities and staff implement quality~     person-centered care, which is the goal of the National Partnership to Improve Dementia Care~     and Reduce Antipsychotic Use in Nursing Homes.~   "
42185|NCT03014557|"~     This registry is designed to observe the safety and effectiveness of WATCHMAN left atrial~     appendage closure technology in a Chinese population.~   "
42186|NCT03014544|"~     The purpose of this study is to compare the psychometric properties (performance validity) of~     8 individual cognitive tests in a computer-administered cognitive test battery intended for~     the assessment of cognitive function in participants with major depressive disorder (MDD)~     either in partial or full remission against 8 corresponding standard, non-reference,~     examiner‑administered cognitive tests.~   "
42187|NCT03014531|"~     The study was conducted to investigate the effects of daily almond intake based on the timing~     of almond consumption (i.e., almond consumption as a preload or between-meal snack) on body~     composition, lipid profile, and oxidative and inflammation indicators among young Korean~     adults.~   "
42188|NCT03014518|"~     Suicide is one of the most devastating events in society at all levels. The primary goal of~     this study is to predict suicide in adolescents at risk. We will utilize blood biomarker~     measurement and clinical risk factor scales to develop a tool to identify adolescents at risk~     for suicide earlier, which will allow clinicians to prescribe timely treatment and prevent~     suicide.~   "
42189|NCT03014505|"~     Imbalance of gut bacteria is suspected to play a key role driving the progression of~     cirrhosis and there is hope manipulation of these bacteria may be beneficial. This study will~     determine if fecal microbiota transplantation is an effective and safe treatment for~     decompensated cirrhosis.~   "
42190|NCT03014492|"~     The purpose of the study is to monitor longitudinal changes in brain structure and function~     between the preseason and postseason, in a population of soccer playing athletes wearing the~     Device and compared to a similar population not wearing the device. Secondly, the purpose is~     to determine the protection of the device relative to amount and magnitude of sustained head~     impacts.~   "
42191|NCT03014479|"~     The purpose of this study is to assess the reduction in treatment burden during 12 weeks of~     trelagliptin administration in patients with type 2 diabetes on diet and exercise therapy~     only.~   "
42192|NCT03014466|"~     Preoperative anxiety in pediatric patients undergoing surgical procedures has been previously~     shown to increase the likelihood of family stressors, post- operative pain, agitation, sleep~     disturbances, and negative behavioral changes. The purpose of this study is to use a~     non-invasive device to determine whether a bed mounted Video Projection unit (i.e. BERT,~     Bedside EnterRtainment Theater) is more effective than the standard of care tablet (i.e.,~     iPad) for preventing anxiety before surgery among children undergoing anesthesia and surgery.~     The anticipated primary outcome will be reduction of child's anxiety in the preoperative and~     operating room setting and compliance with mask induction.~   "
42193|NCT03014453|"~     Bronchopulmonary dysplasia(BPD) is a common condition in the low birth weight~     infants.Although most of the BPD symptoms improved after a regular treatment in infancy,~     there are still a few late complications left such as the frequent respiratory symptoms, a~     slower weight gain and even sudden death. These late complications have made so much trouble~     to the healthcare of BPD infants.How to find the risk factors and to reduce the prevalence of~     these late symptoms becomes necessary. It has been reported that gastroesophageal~     reflux(GER)is a long-lasting form in the extremely premature infants with BPD,however,whether~     it serves as a potential risk for the late complications is still unclear.In this study, a~     cohort of BPD infants was observed with the late complications obtained by a monthly followed~     up for 12 months after discharge, the prevalence and risk factors were analyzed by Cox's~     proportional hazards regression model.As one of the risk factors, GER was verified whether to~     play a critical role in these late complications.~   "
42194|NCT03014440|"~     The purpose of this study is to determine if cannabidiol is safe and effective at different~     doses as an additional treatment for pediatric drug-resistant epilepsy. Pure cannabidiol has~     potentially therapeutic properties, such as anti-convulsant effects, that may reduce seizure~     frequency. There are only a few open label studies that have demonstrated the safety and~     tolerance of cannabiodiol in both adult and pediatric epileptic populations--these studies~     were performed either retrospectively or with varying cannabidiol preparations. There are no~     well-documented studies and completely analyzed data for pediatric epileptic patients.~   "
42300|NCT03013062|"~     Since the pulmonary artery hypertension is defined based on MPAP and the two previous~     formulae relating MPAP and PAT were derived in western population, the investigator planned~     to conduct a prospective study to derive a new formula for measuring MPAP from PAT in Indian~     population and compare the accuracy of all the three formulae~   "
42195|NCT03014427|"~     The storage and use of biomaterial samples is an important requirement for accompanying~     research and the acquisition of new knowledge to improve prognosis and therapy. Biobanking is~     explicitly recommended in official guidelines. In order to preserve the biomaterial, the~     patient must consent to the removal, transfer and storage of the biomaterial separately from~     the consent to the register. The biomaterial is taken at times at which a blood or urine~     sampling takes place anyway in the clinical routine. Therefore no additional interventions~     are necessary.~   "
42196|NCT03014414|"~     People with elevated blood pressure are at higher risk of having a heart attack or stroke~     than people with lower blood pressure. Losing a modest amount of weight—such as 15 or 20~     pounds—can reduce the risk of having a heart attack or stroke. However, it can often be a~     struggle to maintain weight loss over time.~      This study examines whether two behavioral weight-management programs can help people~     maintain weight loss over time. In this study, 346 adults will be randomly assigned (like~     flipping a coin) to one of the 12-month programs and followed for 36 months (i.e., 3 years)~     to see how their body weight may change.~   "
42197|NCT03014401|"~     The purpose of this study is to compare the clinical and functional outcomes of patients with~     mild to moderate arthroscopically confirmed osteoarthritis between the following two groups:~        1. Partial fat pad harvest with Adipose-Derived Stem Cell (ADSC) transplantation with~          standard arthroscopic treatment consisting of: partial meniscectomy, cartilage~          stabilization, loose body removal and selective synovectomy.~        2. Standard arthroscopic treatment (above) with out cell transplant.~   "
42198|NCT03014388|"~     Using growth factors obtained from patient's venous blood mixed with particulate autogenous~     bone the study compares bone gain by implant with gold standards in sinus Lift procedures for~     future implant insertion.~   "
42199|NCT03014375|"~     The purpose of this study is to:~      To determine the rate and routes of excretion of BIA 5-453 and the mass balance in urine and~     faeces~   "
42200|NCT03014362|"~     The purpose of this study is to determine if the use of Transcranial Magnetic Stimulation~     (TMS) provides rapid reduction and sustained attenuation of suicidal crisis. TMS is a~     treatment for suicidal crisis that is quicker, less invasive, better tolerated, and with~     fewer side effects than current treatments such as Electroconvulsive Therapy (ECT) and~     medication therapies. There will be 6 months of follow-up, in order to establish the ongoing~     and lasting therapeutic effect of TMS.~   "
42201|NCT03014349|"~     The purpose of this study is to evaluate the reproducibility of tonometry in the Goldmann~     applanation apparatus and pneumatic in the water drinking test.~   "
42202|NCT03014336|"~     The drawbacks of chemical CO2 absorbers include the production of compounds harmful to~     patients that also lead into increased cost and environmental impact, as well as the daily~     disposal of compound special waste. Sustainable management of general anesthesia is a growing~     concern. Continually diluting anesthetic circuits, and the disposal of chemical granulate are~     serious environmental problems.~   "
42203|NCT03014323|"~     Investigators will test the hypothesis that chronic restoration of vagal nerve activity with~     a central acetylcholinesterase inhibitor improves insulin sensitivity and reduces adipose~     tissue oxidation in obese African American Women compared to white women.~   "
42204|NCT03014310|"~     This is a Phase I cohort-randomized, double-blind, controlled trial designed to assess the~     safety, reactogenicity, and immunogenicity of a monovalent inactivated influenza A/H5N8 virus~     vaccine administered at different dosages (3.75 and 15 mcg of HA per dose) given with or~     without AS03 or MF59 adjuvants. This study will be conducted at 6 sites and enroll 150 (up to~     380) males and non-pregnant females, 19 to 64 years old, inclusive who are in good health and~     meet all eligibility criteria. The entire study duration is approximately 24 months and each~     subject participation duration is approximately 13 months. The primary objectives are: 1) To~     assess the safety and reactogenicity of a monovalent inactivated influenza A/H5N8 virus~     vaccine following receipt of two doses administered intramuscularly at different dosages~     (3.75 and 15 mcg of HA per dose) given with or without AS03 or MF59 adjuvants approximately~     21 days apart. 2) To assess the serum HAI and Neut antibody responses to a monovalent~     inactivated influenza A/H5N8 virus vaccine following receipt of two doses administered~     intramuscularly at different dosages (3.75 and 15 mcg of HA per dose) given with or without~     AS03 or MF59 adjuvants approximately 21 days apart.~   "
42205|NCT03014297|"~     This is a single center, open label, phase I study involving grade I-III~     gastroenteropancreatic neuroendocrine tumors, consisting of a dose escalation Part A followed~     by an expansion cohort Part B. On Part A Patients will be treated with daily oral everolimus.~     Fosbretabulin will be administered IV either q3 weekly or q weekly based on PO CRM cohort.~     Part B: Once the investigators have established an MTD in Part A, the investigators will be~     treating 15 more patients at that dose combination. The primary and secondary objectives of~     the expansion cohort will be similar to Part A of the study, i.e., to establish a safety~     profile of the experimental drug combination and to collect and assess efficacy data.~     Patients will be treated with concurrent everolimus and fosbretabulin for 12 weeks.~   "
42206|NCT03014284|"~     This is a simple tissue collection study with no therapeutic intent. Colon tissues will be~     taken from standard of care procedures. Tissues will be tested for their functions,~     expression of immune co-signaling molecules and reactions to transduction with recombinant~     Listeria vectors to assess effects on expression of B7-H1 and cytokines.~   "
42207|NCT03014271|"~     Sources of Strength is an evidence based program for youth suicide that trains student key~     leaders to strengthen social connectedness and healthy norms school-wide and is listed on the~     National Registry of Evidence Based Programs and Practices (NREPP). This project will expand~     the existing evidence base by evaluating Sources of Strength for sexual violence outcomes in~     a randomized controlled trial (RCT) in twenty-four high schools.~   "
42208|NCT03014258|"~     This is a phase I study that will assess the acquisition of immunity to Pf malaria over the~     course of 2-4 sequential Controlled Human Malaria Infections (CHMI) over 2-3 years, in 10~     healthy adult participants. The study is expected to last for 48 months and will include 28~     healthy male and female volunteers (10 active study volunteers and 18 naïve controls to~     confirm Pf infectivity during the 2nd -4th CHMI challenges) ages 18 to 45 years, inclusive,~     from the greater Baltimore community.~      The primary objective of this study is to determine whether protective immunity against~     parasite infection develops following repeat CHMI.~   "
42209|NCT03014245|"~     Melatonin is well known for its role in the sleep-wake cycle but it is less well known as an~     effective antioxidant. It has been reported to be synthesised in the placenta and may have~     both receptor mediated and non-receptor mediated protective functions during pregnancy.~     Severe pre-eclampsia has been reported to be associated with low levels of melatonin in the~     placenta although it is not known if the placental melatonin contributes to circulating~     levels. There is little reported on the circulating levels of melatonin or oxidative stress~     at different stages of normal pregnancy. More information on the role of melatonin and~     metabolism of melatonin in pregnancy as well as any significant association with adverse~     pregnancy outcomes would inform planning of larger research studies to investigate the~     potential role for melatonin as a biomarker for obstetric disease and potentially as a~     therapeutic agent in future.~      This observational pilot study aims to measure serum melatonin levels and 6-hydroxymelatonin~     sulphate (the major metabolite of melatonin) during each trimester of pregnancy.~   "
42210|NCT03014232|"~     Hypercytokinemia contributes a major role in the pathogenesis and is associated with the high~     mortality in sepsis-related acute kidney injury(AKI). This pilot randomized controlled trial~     was conducted in sepsis-related AKI patients to compare the efficacy of cytokine removal~     including interleukin(IL)-6, IL-8, IL-10, and tumor necrotic factor(TNF)-α by six-hour SLED-f~     between using HCO dialyzer(HCO-SLED-f) and HF dialyzer(HF-SLED-f).~   "
42211|NCT03014219|"~     The investigators propose to study the safety of autologous mesenchymal stromal cell transfer~     using a biomatrix (the Gore Bio-A Fistula Plug) in a Phase I study using a single dose of 20~     million cells. 20 patients (age 12 to 17 years) with Crohns perianal fistulas will be~     enrolled.~      Subjects will undergo standard adjuvant therapy including drainage of infection and placement~     of a draining seton. Six weeks post placement of the draining seton, the seton will be~     replaced with the MSC loaded Gore fistula plug as per current clinical practice. The subjects~     will be subsequently followed for fistula response and closure for 24 months. This is an~     autologous product derived from the patient and used only for the same patient.~   "
42212|NCT03014206|"~     This study aims to understand the following items in post-marketing actual clinical settings~     to evaluate the safety of 13vPnC administered as a single dose in the elderly (adults aged 65~     years or older).~        1. To confirm the use in actual clinical settings~        2. To confirm the occurrence of adverse events~   "
42213|NCT03014193|"~     This study evaluates the usability of the multilevel pregnancy test among women undergoing~     medical abortion.~   "
42214|NCT03014180|"~     The purpose of the LEVEA study is to assess the performances of a new automatic left~     ventricular auto threshold (LVAT) algorithm (In-Clinic LVAT algorithm) when used by~     physicians during in-hospital follow-up.~   "
42215|NCT03014167|"~     Over 1.5 billion people are infected with soil-transmitted helminths (STH). Global STH~     guidelines recommend MDA (mass drug administration) of albendazole or mebendazole to targeted~     populations, including pre-school age children and school-age children. However mathematical~     models suggests that current MDA strategies are not sufficient for interrupting disease~     transmission in most areas. Meanwhile many lymphatic filariasis (LF) programs have~     successfully treated entire populations with albendazole (in combination with ivermectin or~     diethylcarbamazine) and are transitioning to a state of post-MDA surveillance. This project~     will conduct a series of community-based cluster randomized trials in India, Malawi, and~     Benin to determine if maintaining three years of MDA with albendazole to entire communities~     following the cessation of LF programs can interrupt STH transmission in focal geographic~     areas. Additionally, this study aims to compare the efficacy of community-wide MDA versus~     targeted MDA of children in interrupting the transmission of STH. Nested implementation~     science research will be used to optimize the intervention, identify contextual factors~     influencing trial efficacy, and evaluate the feasibility of sustaining and scaling~     community-wide MDA for STH. These data will provide evidence necessary to inform future~     guidelines, policies, and operational plans as country partners engage in intensified~     approaches to eliminate these disabling diseases.~   "
42216|NCT03014154|"~     Asthma is a chronic inflammatory disease of the Airways of recurring character. The~     obstruction to the airflow carries the short-and long-term consequences that require~     prophylactic interventions and in emergency many times. The children due to immaturity of the~     respiratory system associated with the use of steroids suffer structural consequences, as for~     example, the physical deconditioning that intensifies the symptoms of the disease and affects~     negatively on the quality of life. Therefore, to set up a physical training program suitable~     for the paediatric population, using resources to increase adherence to the regular practice~     of exercises, can be the difference for the reduction of the number of exacerbations, the~     sensation of Dyspnea and the doses of medication, positively impacting the clinical picture~     of child asthmatic. The investigators conducted a randomized, blinded in order to evaluate~     the effects of training with active video game associated with resisted exercise the exercise~     in inflammatory and functional outcomes resisted in asthmatic children.~   "
42217|NCT03014141|"~     The consumption of oat bran fiber also has a significant bulking effect in humans. However,~     besides fecal bulk, dietary fiber can promote gut health in other ways. Therefore, the~     purpose of this study is to investigate the effects of oat bran (rich in oat beta-glucan)~     supplementation on bowel function and appetite.~   "
42218|NCT03014128|"~     Work-related upper extremity musculoskeletal disorders (WRUEMSDs) have shown to be related to~     many occupational situations and specific industries. However, there is conflicting~     information about monotonous and repetitive activities. In this context, the profession of~     surgical device mechanics has not been analyzed so far.~      The objective of this study is to examine surgical device mechanics at different workplaces~     with varying work contents and to compare them with a control group without the repetitive~     workload exposition as described above. The headquarters and main production site of Aesculap~     are located in Tuttlingen/Germany. Aesculap is the world leading manufacturer of surgical~     devices.~      After statistical power analysis, the investigators plan to randomize and include a total of~     90 voluntary test persons in 3 groups (30 persons each). The study will include standardized~     questionnaires and a physical examination as well as an industry test (Purdue Pegboard Test).~      Primary and secondary endpoints were defined to show if significant difference between~     surgical device mechanics and a control group is present.~   "
42219|NCT03014115|"~     The clinical trial will investigate the effect of different formulations of ARA + 0.4% DHA in~     infant formula on plasma fatty acid status in healthy 6 months old infants supplemented for 6~     months. A 6-month follow on phase will provide additional efficacy (e.g. infection rates,~     immune markers) and safety information in these 12-18 month old infants.~   "
42220|NCT03014102|"~     The purpose of this study is to determine whether recombinant human thrombopoietin are~     effective in peripheral blood progenitor cells mobilization for autologous transplantation.~   "
42221|NCT03014089|"~     The clinical study will assess the safety, tolerability, and immunogenicity of mRNA-1325 in~     healthy adult subjects.~   "
42222|NCT03014076|"~     The purpose of this trial is to determine if combination immunotherapy with HER2/neu GP2~     peptide + GM-CSF vaccine and trastuzumab is safe and immunologically effective in treatment~     of patients with HER2/neu over-expressing breast cancer in the adjuvant setting. While not a~     primary endpoint, time to recurrence is measured for enrolled subjects. The objectives of the~     study are the following:~        -  Assess safety and document local and systemic toxicity to combination immunotherapy with~          GP2 peptide + GM-CSF vaccine and trastuzumab~        -  Evaluate the in vitro and in vivo immunologic responses to combination immunotherapy of~          GP2 peptide + GM-CSF vaccine and trastuzumab~        -  Determine maximum tolerated dose and optimal biologic dose for the combination~          immunotherapy of GP2 peptide + GM-CSF vaccine and trastuzumab~   "
42223|NCT03014063|"~     This is a prospective observational cohort trial evaluating a single plasma vasopressin~     concentration in patients receiving exogenous, adjunctive vasopressin for septic shock. The~     trial is designed to determine whether plasma vasopressin concentration influences the~     likelihood of hemodynamic response to exogenous vasopressin therapy.~   "
42224|NCT03014050|"~     Parkinson's disease (PD) is a neurodegenerative disorder characterized by motor dysfunction~     and non-motor symptoms. Here, we propose to examine whether Bio Electro Stimulation Therapy~     (B.E.S.T.) with a small, non-invasive, handheld electronic device designed to apply micro~     current stimulation to a person's hand can ameliorate some of the symptoms of PD.~   "
42225|NCT03014037|"~     Musculoskeletal conditions are common sources of pain. Specifically, osteoarthritis affects~     nearly 27 million people in the United States. This disease leads to the breakdown of the~     cartilage surfaces of the joints, which serve as the connection points between the bones of~     the body, causing a large amount of pain and disability in patients. Increasing the number of~     available treatment options for osteoarthritis is becoming increasingly more important as~     Americans continue to age. Using stem cells taken from bone marrow is one of the~     non-operative treatments that has been gaining popularity in the recent past. This study aims~     to clarify how this procedure should best be done by comparing stem cell concentrations and~     patient outcomes (short and long term) in patients who have stem cells taken from one area vs~     two (unilateral vs bilateral posterior superior iliac spine (PSIS) aspirations).~   "
42226|NCT03014024|"~     Conservative treatment of distal radius fracture is immobilisation with cast for 4-6 weeks.~     After removing the cast, it is common to still have pain, swelling and reduced mobility in~     the wrist. The aim of this study is to evaluate the influence of LLLT on the hand.~   "
42227|NCT03014011|"~     Hypoglycaemia in subjects suffering from type 2 diabetes may have substantial consequences~     including a significant negative impact on quality of life. Further, repeated minor~     hypoglycaemias may result in significant productivity losses.~      Here, the investigators propose to provide quantitative results on cognition during an acute~     mild hypoglycaemic episode (target plasma glucose 3 mmol/L) in 28 subjects with type 2~     diabetes. Data will be provided on executive function, attention and memory.~   "
42228|NCT03013998|"~     This screening and multi-sub-study Phase 1b/2 trial will establish a method for genomic~     screening followed by assigning and accruing simultaneously to a multi-study Master Protocol~     (BAML-16-001-M1). The specific subtype of acute myeloid leukemia will determine which~     sub-study, within this protocol, a participant will be assigned to evaluate investigational~     therapies or combinations with the ultimate goal of advancing new targeted therapies for~     approval. The study also includes a marker negative sub-study which will include all screened~     patients not eligible for any of the biomarker-driven sub-studies.~   "
42229|NCT03013985|"~     The purpose of this study is to find out if treatment with Glargine U300 when compared to~     Glargine U100 will result in similar sugar control in patients with Type 2 Diabetes (T2D),~     who are admitted to the hospital and then transition at home, after discharge from the~     hospital.~   "
42230|NCT03013972|"~     Worldwide, nearly 1.25 million patients are diagnosed with and more than 600,000 patients die~     from colorectal cancer each year. The third leading cause of death is colorectal cancer in~     Taiwan 2012. The current treatments for colorectal cancer including surgery, chemotherapy~     and/or radiotherapy are prescribed to improve survival and lower the risk of recurrence.~     However, disease and treatment-related toxicities in cancer patients may result in fatigue~     and interfered quality of life (QoL). Previous studies have reported that cancer-related~     fatigue (CRF) is the most common symptom experienced by patients at all stage of diseases, it~     can occur during treatment, in advanced disease and in disease-free survivors; the prevalence~     of fatigue is reported to be between 59-96% in patients undergoing chemotherapy, 65-100% in~     patients receiving radiation therapy, and 30% in long term survivors. Also, CRF has been~     reported as the most frequent and distressing toxicity of colon and rectal chemotherapy. The~     National Comprehensive Cancer Network (NCCN) has published guidelines for the definition of~     CRF as ''a persistent subjective sense of physical, emotional, and/or cognitive tiredness or~     exhaustion related to cancer or cancer treatment that is not proportional to recent activity~     and that significantly interferes with usual functioning. Besides, CRF could dynamically~     change with the interactions among disease progression, treatment regimen, tumor site,~     nutrition, infection or other factors. Therefore, to minimize the impact of CRF on cancer~     patients, more in-depth researches on CRF are needed.~      The aim of this longitudinal study is to examine the dynamic changes, correlated factors and~     QoL of CRF among colorectal cancer patients during adjuvant chemotherapy. Furthermore, the~     results will supply physicians with more understanding about CRF, and help them to enhance~     the quality on cancer care to being perfected in the future.~   "
42231|NCT03013959|"~     As is reported, NSAIDs(pranoprofen ,bromfenac) eye drops can suppress herpes simplex~     virus（HSV-1） reactivation and reduce inflammatory reaction in vitro and in vivo. In Clinical,~     there is no risk of corneal tissue melting, glaucoma, cataract by topical application of~     NSAIDs. To explore more effective clinical treatment of viral keratitis patients to control~     the inflammatory damage, save the visual function and reduce the recurrence of the virus ,we~     observe the effect of anti-inflammatory and inhibition of recurrence on the herpes simplex~     virus after topical NSAIDs administration.~   "
42232|NCT03013946|"~     The primary objective of the trial is to determine the effect of a 24-week concomitant~     coaching on patient reported outcomes of patients receiving standard treatment for mRCC with~     sunitinib.~   "
42233|NCT03013933|"~     This phase I trial studies the side effects and best dose of brentuximab vedotin and~     cyclosporine when given together with verapamil in treating patients with Hodgkin lymphoma~     that has come back or does not respond to treatment. Monoclonal antibodies, such as~     brentuximab vedotin, may interfere with the ability of cancer cells to grow and spread.~     Immunosuppressive therapies, such as cyclosporine, may improve bone marrow function and~     increase blood cell counts. Verapamil may increase the effectiveness of brentuximab vedotin~     by overcoming drug resistance of the cancer cells. Giving brentuximab vedotin, cyclosporine,~     and verapamil may work better in treating patients with Hodgkin lymphoma.~   "
42234|NCT03013920|"~     Rationale: Initial evaluation usually consists of cross sectional imaging of the urinary~     tract. When a suspect lesion is seen, an ureterorenoscopy is planned to visualize the lesion~     and to collect tissue for histopathology. These techniques are considered to be the gold~     standard in diagnosis of UTUC. CLE, a high resolution imaging technique that can be used in~     combination with endo-urological procedures, seems promising to improve diagnosis of~     urothelial cancer. CLE image characteristics for UTUC still have to be defined.~      Objective: With this IDEAL stage 2b explorative pilot study the investigators aim to assess~     in-vivo CLE image characteristics of normal urothelium, benign urothelium and urothelial~     carcinoma (low-grade, high-grade or CIS) of the upper urinary tract by qualitatively~     comparing CLE images with both histopathology from diagnostic biopsies and pathology from the~     therapeutic radical nephroureterectomy. Secondary objectives are the development of an~     imaging atlas and to assess the technical feasibility and procedure related adverse events of~     CLE.~   "
42235|NCT03013907|"~     The purpose of this study is to adapt and then evaluate the feasibility, acceptability, and~     efficacy of a telephone-based intervention (UPLIFT: Using Practice and Learning to Increase~     Favorable Thoughts) for individuals with elevated depressive symptoms and hypertension.~     UPLIFT is a group-based intervention that is delivered over 8 weekly sessions for 1 hour/week~     by phone.~      Aim 1 of this study is to adapt UPLIFT using qualitative focus groups and individual~     interviews and to test the adapted UPLIFT program in a single-arm design. Aim 2 of this study~     is a randomized controlled trial (RCT) that will compare the effects of the adapted UPLIFT~     program to usual care (UC) and to test mediators and moderators of the effects of UPLIFT.~   "
42236|NCT03013894|"~     Rationale: Cystoscopy and cytology, the current 'gold standard' for detection and follow-up~     of primary and recurrent bladder cancer have some limitations. CLE, a high resolution imaging~     technique, that can be used combined with endo-urological procedures, seems promising to~     improve diagnosis of bladder cancer. The diagnostic accuracy of cystoscopic applied confocal~     laser endomicroscopy (CLE) still has to be defined.~      Objective: To directly correlate CLE images with histopathology, and identify and define CLE~     characteristics of normal urothelium, benign bladder urothelium, and bladder tumors~     (low-grade, high-grade and carcinoma in situ (CIS)) of the lower urinary tract.~      Primary objective: to develop descriptive image interpretation criteria and a classification~     of CLE images of bladder tissue through a review of prospectively obtained CLE videos from~     bladder tissue correlated with histopathology.~      Secondary objectives:~        -  Assessing procedure related adverse events of CLE~        -  Assessing technical feasibility of CLE~        -  To develop a CLE image atlas for urothelium of the lower urinary tract (normal, benign,~          low-grade or high-grade and CIS)~   "
42237|NCT03013881|"~     The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of~     escalating single-dose of UB-921 in healthy male volunteers.~   "
42238|NCT03013868|"~     Despite the growing public awareness and recent progress in multimodality therapy to the~     colorectal cancer (CRC), CRC still ranks high on the list of the most common and deadly~     cancers in Taiwan. The cause of CRC mortality is due mainly to the occurrence of distant~     metastasis. Several reports suggested that circulating tumor cells (CTCs) highly associated~     with metastasis suggesting that targeting CTCs may offer an unprecedented opportunity to~     prevent the development of metastasis. Early detection and characterization of CTCs is~     therefore important as a potential strategy to monitor the progression of CRC. The current~     proposal is focused on detecting CTCs from peripheral blood of CRC patients using Miselect R~     system. We will monitor the amount of CTCs and correlate with CRC progression and prognosis.~   "
42239|NCT03013855|"~     This study will investigate the use of digital rectal exam (DRE) to obtain stool samples for~     the fecal immunochemical test (FIT) in patients due for screening colonoscopy and in~     pre-operative patients with known colorectal cancer. FIT is currently FDA-approved for~     spontaneous stool and DRE, however, samples are not commonly obtained by DRE. In addition,~     some clinicians remain skeptical about the accuracy of FIT using stool obtained from DRE.~     This study aims to assess the correlation between FIT using the stool sample from DRE~     (FIT-DRE) and standard of care FIT (FIT-SOC). If good correlation is shown, the investigators~     may be able to demonstrate efficacy of FIT using a DRE in the clinic setting. This may help~     avoid logistical barriers, as well as improve compliance and adherence to colon cancer~     screening in the outpatient setting, eventually leading to improved quality of care.~   "
42240|NCT03013842|"~     Three non-invasive, trans-abdominal fetal oximetry probes will be tested on pregnant human~     subjects, in order to obtain fetal heart rate.~      We want to determine if this device can accurately measure a baby's oxygen level when placed~     on your abdomen.~      Current technology to measure a baby's oxygen levels requires a probe to be inserted into the~     vagina.~   "
42241|NCT03013829|"~     The purpose of this study is to evaluate the effectiveness of a targeted educational approach~     designed to increase knowledge about the risks and benefits of living donation generally and~     KPD (Kidney Paired Donation) specifically, enhance KPD self-efficacy, reduce KPD concerns,~     and facilitate informed decision making about KPD among incompatible or cross-match positive~     donor-recipient pairs.~   "
42242|NCT03013816|"~     The objective of this study is to evaluate the effectiveness of targeted video interventions~     designed to increase organ donation knowledge, intentions, and designations among adolescents~     enrolled in driver's education classes, as well as to increase the commitment of~     parents/legal guardians to authorize organ donation in the event of their adolescent's death.~     The central hypothesis is that integrating donation education into the driver's education~     curriculum will increase knowledge and attitudes that facilitate the behavioral action of~     donor designation at the time of getting a new driver's license.~   "
42245|NCT03013777|"~     To determine the effect of cognitive behavioral therapy (CBT) in the severity of anxiety and~     depression in adult patients with familial dysautonomia. Patients will be enrolled in an~     8-week CBT program. All CBT sessions will be done either in person at the NYU Dysautonomia~     Center or over the phone to help accommodate disability and potential physical limitations of~     our patient population.~   "
42246|NCT03013764|"~     Physical inactivity results in reductions in glucose tolerance and less sensitivity to~     insulin. If this inactivity lasts long enough it can result in insulin resistance and type 2~     diabetes. A high protein diet can reduce elevated glucose levels in individuals with type 2~     diabetes. Thus the investigators are interested in establishing if during a period of~     inactivity if a diet modification can minimize the glucose changes normally observed with~     inactivity. The objective of this project is to determine if short-term high protein (HP)~     feeding protects against the changes in glucose levels normally observed with physical~     inactivity. The investigators will also examine measures of blood vessel function, blood~     lipid and blood pressure.~      Twelve subjects will complete two 10 day study periods of reduced physical activity and will~     be studied before and after each of these study periods. For their testing subjects will have~     the following measurements: postprandial glucose responses to a mixed meal, 24 h free living~     blood pressure control during acute physical inactivity, blood lipids, changes in body~     composition, changes in circadian rhythm using skin temperature (ibutton), measurement of~     aerobic capacity (VO2 max), blood vessel responsiveness (flow mediated dilation -FMD) and~     changes in free living glucose levels (continuous glucose monitoring system (CGMS). Subjects~     will complete two conditions (high protein -HP vs normal protein - NP diets) in a randomized~     cross-over design. In the inactive phase subjects will reduce there steps to &lt;5,000~     steps/d while consuming either a HP or NP diet. Completion of the study will take 8-10 weeks.~   "
42247|NCT03013751|"~     This study is a 12-month (52 week) safety extension study to supplement the FUEL Phase III~     clinical trial to provide safety information regarding the long-term use of udenafil in~     adolescents with single ventricle congenital heart disease.~   "
42248|NCT03013738|"~     This randomized controlled trial aimed to assess the efficacy of a 40-session~     cognitive-behavioral group program, Growing Pro-Social (GPS), in reducing early maladaptive~     schemas and cognitive distortions (primary outcomes), as well as anger, shame and paranoia~     (secondary outcomes). The GPS's impact on behavioral change (e.g., in the reduction of~     disciplinary incidents and prison records) was also tested, in order to ascertain if changes~     observed in cognitive and emotional variables were reflected in a more adjusted behavioral~     pattern. Personality Disorders were also tested as moderators of treatment effects.~   "
42249|NCT03013725|"~     The Hordaland Health Studies (HHS) were conducted in 1992-93 (The Homocysteine study) and in~     1997-99 (HUSK). Both surveys were conducted as a joint project between the University of~     Bergen, the Norwegian Health Screening Service (SHUS) (now part of the National Institute of~     Public Health) and the Municipal Health Service in Hordaland.~      The main focus of the studies is on chronic diseases including cardiovascular disease,~     cancer, osteoporosis, anxiety and depression. Some projects focus on psychosocial factors,~     occupational research, musculoskeletal diseases, urinary incontinence and mapping of drug~     use. The main purpose of the surveys is to gather information so that disease ultimately can~     be prevented.~      Approximately 36,000 residents of Hordaland county participated in the studies, ca. 18,000 in~     1992-93 and ca. 26,000 in 1997-99. About 7,000 of those who participated in the 1992-93~     survey also participated in 1997-99.~   "
42250|NCT03013712|"~     The purpose of this study is to evaluate the safety and efficacy of EpCAM-specific CAR T~     Cells infusion for EpCAM positive Cancer.~   "
42251|NCT03013699|"~     This study will examine the effects of a dietary intervention in post-treatment head and neck~     cancer survivors on the ability to function physically, tiredness, and quality of life, as~     well as on changing markers in the blood that are associated with better recurrence and~     survival.~   "
42252|NCT03013686|"~     The PeriAPPAC trial is a prospective randomised study comparing interval laparoscopic~     appendectomy with follow-up MRI in patients with initially successfully treated~     periappendicular abscess.~      Periappendicular abscess is generally initially treated conservatively with antibiotic~     therapy and if necessary, drainage. Operative treatment in the acute abscess phase is~     associated with increased morbidity and thus complicated appendicitis with a periappendicular~     abscess is initially treated conservatively. However, there is debate on whether interval~     appendectomy is required.~      After initial successful conservative treatment of a CT- or MRI-diagnosed periappendicular~     abscess, patients enrolled in the PeriAPPAC study are randomised either to interval~     appendectomy or to follow-up with MRI at two months after the initial treatment. All patients~     also undergo a colonoscopy, appendectomy patients prior to surgery and MRI patients after the~     MRI (outpatient visit at endoscopy unit with information on the MRI).~      The primary endpoint is the treatment success in both treatment arms. In the interval~     appendectomy evaluated as possible morbidity related to appendectomy and in the follow-up~     treatment arm as possible recurrence of the appendicitis and/or abscess during a one-year~     follow-up.~      The PeriAPPAC study is a multi centre trial and the participating hospitals are Turku~     University Hospital, Oulu University Hospital, Tampere University Hospital, Kuopio University~     Hospital and Seinäjoki Central Hospital.~   "
42253|NCT03013673|"~     In this cohort study, the investigators will study the asymptomatic period preceding the~     onset of active Visceral Leishmaniasis (VL) in HIV‐infected individuals from VL endemic~     regions in Ethiopia as an avenue to develop an evidence‐based screen and treat strategy to~     prevent progression to active VL.~   "
42267|NCT03013491|"~     The purpose of this first-in-human study of CX-072 is to characterize the safety,~     tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-072~     administered intravenously (IV) as a single agent or in combination with ipilimumab or~     vemurafenib in adult subjects with advanced or recurrent solid tumors or lymphomas.~     PROCLAIM-CX-072: PRObody CLinical Assessment In Man CX-072 clinical trial~      CX-072 is a Probody™ therapeutic directed against PD-L1 (programmed cell death ligand 1).~     Probody therapeutics are proteolytically-activatable antibodies (Abs) designed to widen the~     therapeutic index by minimizing drug interaction with normal tissue while retaining~     anti-tumor activity. Probody therapeutics are masked to attenuate binding to target in~     healthy tissue but can become unmasked in the tumor microenvironment by tumor-specific~     protease activity.~      PROBODY is a trademark of CytomX Therapeutics, Inc.~   "
42254|NCT03013660|"~     Preterm birth is the leading contributor to mortality among children younger than 5 years.~     One effective and inexpensive intervention is providing skin-to-skin care (STSC) whereby the~     mother of a preterm baby provides skin-to-skin contact to the newborn for at least a few~     hours, ideally every day. This intervention can make breastfeeding easier and can improve the~     health and development of the baby.~      Unfortunately, despite the large health benefits, mothers in low-resource communities are~     often unable to practice STSC due to a range of institutional and economic barriers. STSC~     requires substantial time and financial commitments from mothers; they must travel from home~     each day to the hospital to engage in STSC and provide expressed breast milk. Low-income~     women with access only to limited federally provided unpaid family leave may have to choose~     between returning to work while their baby is in the NICU and being able to stay at home with~     their newborn after discharge from the NICU. Families of preterm infants also face direct~     financial costs of practicing STSC and breastfeeding (such as fees for parking and childcare~     for older children).~      This trial aims to examine the impact of providing additional support to low-income mothers~     of babies born preterm in 2 hospitals in Massachusetts to help them provide STSC. Half of the~     participants will be randomized to receive an additional financial support intervention while~     their infant is in the NICU. The study will examine how this intervention impacts mothers'~     health behavior while their child is in the NICU and up to three months after.~      Most of the current and past policy efforts to increase STSC have focused on the delivery of~     STSC at hospitals, focusing on supply-side related challenges such as the lack of trained and~     informed staff. However, interventions that focus exclusively on hospitals are unlikely to be~     sufficient for low-income women if there are significant opportunity costs or transportation~     costs to simply being present at the hospital. This study aims to provide more evidence to~     determine whether removing these financial barriers has the potential to mitigate the poor~     outcomes of preterm babies born to lower socioeconomic status households.~   "
42255|NCT03013647|"~     Twenty patients with multiple actinic keratosis on the face will be enrolled in the study and~     will be treated with Daylight Photodynamic therapy.~      Before and after skin biopsies will be performed, for histological and immunohistochemical~     analysis.~   "
42256|NCT03013634|"~     The purpose of this study was to evaluate the protective effect of dexmedetomidine on~     myocardial injury during liver transplantation~   "
42257|NCT03013621|"~     Acute renal failure (ARF) is a frequent complication in the postoperative cardiac surgery,~     and is a major risk factor for mortality in this context.~      The right ventricular dysfunction post cardiopulmonary bypass (CPB) is also a common~     complication, close to 100% if one takes into account the transient dysfunction.~      A recent study showed that right ventricular dysfunction and the IRA seemed related, rather~     on the slope of venous congestion. We wish to study this phenomenon more specifically in~     particular to offer reliable diagnostic markers of venous congestion.~   "
42258|NCT03013608|"~     Nail bed injuries in children, most frequently under 3 years-old, result in crush injuries.~     The frequency is around 34 percent of the children hand injuries (Claudet et al, 2007). The~     empirical reparation technique is the nail bed suture and the relocation of the nail plate.~     However, some authors think that suture the nail bed could increase the traumatism of the~     nail bed because of the needle, the crush by the clamps and by the stitches too tight~     (Langlois, Yam). An author has proposed, in a prospective, randomized clinical trial to treat~     the nail bed injuries with a glue: the 2-octylcyanoacrylate, without suture of the nail bed.~     Advantages of this technique, claimed by the author, was time saving, with an aesthetical~     result as same as the treatment with suture of the nail bed. A same study validated the~     technique in a paediatric population (Langlois et al., 2010). So, it seems that it is not~     necessary to suture the nail bed. But, in our practice, the investigators noted complications~     not mentioned in previous studies: hematomas causing pain, effusion and dislocation of the~     nail plate, with constrain the patient to consult in emergency. The 2-octylcyanoacrylate is~     difficult to use in nail bed injuries and is expensive. Our hypothesis is the simple~     relocation of the nail plate in nail bed injuries in paediatric population is enough to have~     good to excellent aesthetical results, with less complications and a lower cost, than the~     other techniques. The aim of this study is to assess the aesthetical results 3 months after~     simple relocation of the nail plate for nail bed injuries in children.~   "
42259|NCT03013595|"~     This study evaluates the longitudinal health and social outcomes of adolescent mental health~     service users who are at the transition boundary of their child and adolescent mental health~     service, and whether the implementation of a model of managed transition at the service~     boundary benefits them, as compared to usual care.~   "
42260|NCT03013582|"~     Tendon adhesions of the hand remain a ubiquitous problem facing hand surgeons and hand~     therapists alike. Despite their commonality, no consensus exists as to the best means of~     preventing adhesions, or the most ideal methods to treat them once they have occurred. The~     purpose of this study is to compare patient outcomes after standard operative tenolysis~     performed for adhesions of the hand to outcomes after tenolysis with the use of allograft~     human amniotic membrane.~   "
42261|NCT03013569|"~     This is a pilot feasibility study for a new application of an approved fetal heart rate~     monitoring device system. The objective of this study is to validate the feasibility of~     acquiring the new modality of human fetal bioelectrical activity, EEG, derived from the~     routinely used scalp fetal heart rate (FHR) monitor.~   "
42262|NCT03013556|"~     The current study is a prospective, randomized, open, multi-center investigation. The aim of~     the study is to investigate whether the HBeAg seroconversion rate can be improved if applying~     combination therapy in HBeAg positive CHB patients who has achieved~     HBVDNA<105copies/ml，HBsAg≤5000IU/ml, ALT≥ 2ULN or Liver histology G2S2.~   "
42263|NCT03013543|"~     The purpose of the study is to determine the effect of setmelanotide (RM-493) on weight,~     hunger assessments and other factors in patients with rare genetic disorders of obesity,~     including POMC deficiency, LepR deficiency, Bardet-Biedl syndrome and Alström syndrome.~   "
42264|NCT03013530|"~     A new law about the advance directives (AD) has been recently voted in France on February 2,~     2016. This  Claeys-Leonetti  law has made the AD more binding, as in other countries. This~     should lead to a greater respect of the human autonomy principle. However, the interpretation~     of these guidelines is often difficult and may differ between doctors. Indeed, the~     subjectivity of these interpretations could lead to different medical decisions by~     physicians.~      The investigators intend to assess the effect of advance directives (AD) on decision making~     in care by intensivists, using a simulated (hypothetical) situation.~   "
42265|NCT03013517|"~     This is an open-label, follow-up study for subjects who completed the PEPITES study. Subjects~     will be offered enrollment in this follow-up study to receive Viaskin Peanut 250 μg for 2~     additional years if previously on active treatment in the PEPITES study, or for 3 years if~     previously on placebo in the PEPITES study.~   "
42266|NCT03013504|"~     In the TROIKA study, the proposed biosimilar HD201 will be compared to its reference product~     Herceptin®. The aim of the study is to demonstrate equivalence of HD201 and Herceptin® in~     terms of efficacy, safety and pharmacokinetics.~   "
42272|NCT03013426|"~     This Phase 1b study in adults with sickle cell disease (SCD) in steady-state (non-acutely~     ill) aims to evaluate safety and toxicity of NVX-508 in a multi-dosing paradigm as well as to~     determine the maximum tolerated dose (MTD) in this population. The information gained from~     this study will be used in making decisions about the appropriate dose(s) and dosing schedule~     in future multicenter studies of the efficacy of NVX-508 in the treatment of vaso-occlusive~     episodes (VOE).~   "
42273|NCT03013413|"~     This clinical trial studies an ultrasound-based imaging procedure called elastography using~     the Aixplorer system in diagnosing prostate cancer in patients undergoing biopsy. Ultrasound~     is a non-invasive imaging technique that uses high-frequency sound waves to produce images of~     internal structures. Elastography uses ultrasound imaging techniques to examine the stiffness~     or elasticity of a tissue and may enhance the detection of prostate cancer. It is not yet~     known whether elastography imaging using the Aixplorer system works better than standard~     ultrasound imaging in detecting prostate cancer.~   "
42274|NCT03013400|"~     This study evaluates the effect of a 'lithium like' drug called ebselen (SP-1005) versus~     placebo as an 'add on' treatment to help stabilise hypo/manic symptoms in bipolar disorder.~     Half of the participants will receive ebselen and the other half placebo. The trial, will~     last a total of four weeks.~   "
42275|NCT03013387|"~     This is a Phase 2 peptide receptor radionuclide therapy trial of 90Y-DOTATOC in patients with~     somatostatin receptor positive tumors.~   "
42276|NCT03013374|"~     The adequacy of the quality of protein supply could influence the rate and the relative~     composition of weight gain in very low birth weight preterm infants.~      Aim of the study is to investigate protein balance according to feeding regimen and the~     association between human milk feeding and fat free mass content at term corrected age in a~     cohort of very low birth weight infants.~   "
42277|NCT03013361|"~     Postoperative analgesia after FESS can be achieved through opioids, NSAIDs, topical or~     infiltration of local anaesthetic and regional techniques like sphenopalatine ganglion (SPG)~     block, infraorbital nerve block and nasociliary block. As the current evidences regarding the~     benefit of SPG block after FESS is controversial, efficacy of sphenopalatine ganglion block~     will be evaluated using bupivacaine or ropivacaine as local anaesthetic in adult patients~     undergoing FESS under general anaesthesia in this study.~   "
42278|NCT03013348|"~     A retrospective validation study of a post-processing method intended to identify psychogenic~     nonepileptic seizures~   "
42279|NCT03013335|"~     The primary objective of this study is to evaluate the incidence of high-grade (i.e. Grade~     3-4 and Grade 5 of CTCAE v4.0) adverse reactions of interest in patients with metastatic RCC~     who have progressed during or after receiving at least one prior systemic anti-angiogenic~     treatment and who are eligible for nivolumab monotherapy.~   "
42280|NCT03013322|"~     Anticholium® per Se is a randomized, double-blind, placebo-controlled, monocentric trial to~     assess whether the CAP can be transferred from bench to bedside. In this pilot study, 20~     patients with perioperative sepsis and septic shock as a result of intra-abdominal infection~     are enrolled. According to randomization, participants are treated with physostigmine~     salicylate (verum group) or 0.9% sodium chloride (placebo group) for up to 5 days. The mean~     Sequential Organ Failure Assessment (SOFA) score during treatment and subsequent intensive~     care of up to 14 days is used as surrogate outcome (primary endpoint). Secondary outcome~     measures include 30- and 90-day mortality. An embedded pharmacokinetics and pharmacodynamics~     study investigates plasma concentrations of physostigmine and its metabolite eseroline.~     Further analyses will contribute to the understanding of the role of various cytokines in the~     pathophysiology of human sepsis. A computer-generated list is used for blocked randomization.~   "
42281|NCT03013309|"~     This study is a hybrid implementation-effectiveness trial of the Family Check-Up 4 Health~     (FCU4Health), an adapted version of the Family Check-Up, in pediatric primary care. Patients~     will be recruited based on their BMI as documented in the Electronic Health Record (EHR) and~     randomized to receive the FCU4Health or Treatment as Usual.~   "
42282|NCT03013296|"~     Delinieation of GIP's effects during a meal in humans using GIP receptor antagonisation.~   "
42283|NCT03013283|"~     Home ventilation techniques consist mainly of two techniques, Continuous Positive Airway~     Pressure or CPAP and Non Invasive Ventilation or NIV. Whether for CPAP or NIV, pressures are~     delivered to the patient via an interface.~      The efficacy of CPAP and NIV is conditioned in part by the observance of the patients to the~     device. Because the comfort and degree of satisfaction of the patients to its interface is a~     key factor of the observance, side-effects and satisfaction of patients need to be~     continuously evaluated with available interfaces for CPAP and NIV treated patients.~      The purpose of the research is the evaluation of interface side-effects and the degree of~     satisfaction of home care patients treated for at least three months with CPAP or NIV.~   "
42284|NCT03013270|"~     This study investigates the effects of aerobic, resistance, inspiratory training modalities~     outcomes in functional capacity and quality of life of heart failure (HF) patients, aiming~     for the 'optimum' (greek, αριστος=aristos) training program for HF patients.~   "
42285|NCT03013257|"~     Graves' disease (GD) is an autoimmune thyroid disorder caused by stimulating auto-antibodies~     to the thyrotrophin (TSH) receptor on thyroid follicular cells. It is the most common cause~     of hyperthyroidism and approximately 3% of women and 0.5% of men develop GD in their~     lifetime.~      RAI has been shown to be a cost-effective and safe therapy in patients with GD but with some~     disadvantages. In addition, despite its proven efficacy and safety, many patients do not wish~     to undergo RAI because of radiation fear and prefer to either continue ATDs or have surgery.~      High-intensity focused ultrasound (HIFU) is a non-invasive procedure that involves the~     application of a high-energy focused beam for thermal tissue ablation within a targeted zone.~     Similar to the principle of RAI (i.e. using ionizing radiation to ablate thyroid parenchyma~     and cause GD remission), we postulated that the heat energy generated from HIFU could also be~     used to ablate the thyroid parenchyma and cause GD remission. The idea of using heat energy~     to ablate thyroid parenchyma minimally invasively was recently reported using radiofrequency~     ablation but to our knowledge, we are one of the first (if not the first) group to propose~     using HIFU energy to ablate thyroid parenchyma as a definitive treatment for relapsed GD.~      Having obtained ethical approval, a pilot study was conducted to examine the efficacy and~     safety of HIFU as a treatment for relapsed GD. In the pilot study, all patients underwent a~     safe and successful HIFU ablation for relapsed GD. Based on the results of the pilot study,~     we hypothesize that a single HIFU treatment to the thyroid gland may be as effective as our~     standard outpatient fixed-dose of RAI (370MBq) in causing remission of GD at 6-month. If our~     hypothesis turns out to be true, HIFU could become a treatment option for patients who are~     indicated for RAI but do not wish to have it because of one reason or another. HIFU appears~     to induce a faster disease remission and lessen the need of deferring pregnancy and radiation~     precautions because of the absence of radioactivity.~   "
42286|NCT03013244|"~     The purpose of the present study was to investigate the acceptability and efficacy of a~     cognitive dissonance-based (DB) intervention in reducing eating disorder and muscle~     dysmorphia risk factors in men with body dissatisfaction. The investigators hypothesized that~     the program would reduce eating disorder risk factors to a greater degree compared to wait~     list control and that these effects would be maintained at 1 month follow-up.~   "
42287|NCT03013231|"~     Despite the large majority of patients that undergo ACL reconstruction reporting successful~     outcomes in regard to tests of knee function, only about 2/3 return to their prior level or~     athletic activity after surgery. A large amount of research has been conducted investigating~     the effects of psychological factors on return to sports after ACL reconstruction; however,~     the specific role of resilience has yet to be solely analyzed. This study aims to determine~     the effect of variations in patient resilience on their return to sports after surgery.~   "
42288|NCT03013218|"~     A phase 1, dose escalation study of ALX148 in patients with advanced solid tumors and~     lymphoma~   "
42289|NCT03013205|"~     Steroid injections are widely utilized to reduce inflammation and fibrosis in patients with~     the frozen shoulder. In this study, investigators will compare intra-articular steroid~     injections with direct coracohumeral ligament steroid injection to conventional~     intra-articular steroid injection. Investigators will measure the primary outcome as shoulder~     function improvement and secondary outcomes as ROM, pain scale and stiffness of coracohumeral~     ligament under elastogram.~   "
42290|NCT03013192|"~     Patients who are prescribed physical therapy exercises for their shoulder will have increased~     compliance to their PT exercises, an increased ASES score, and will have increased range of~     motion (or reach maximum range of motion earlier) at the end of the 3 month~     EpxPhysicalTherapy intervention.~   "
42291|NCT03013179|"~     This project, the Intergenerational Blood Pressure Study, is a 5 year research study funded~     by the National Institutes of Health/National Institute of Nursing Research and led by the~     Yale University School of Nursing and The Consultation Center at the Yale University School~     of Medicine, Department of Psychiatry in partnership with Head Start programs across CT. The~     investigators seek to reduce hypertension health disparities among underserved Black/African~     American children and their mothers by conducting community-based research to better~     understand the genetic, psychological, and environmental factors that may contribute to high~     blood pressure.~   "
42292|NCT03013166|"~     To describe clinical outcomes and both primary and secondary care health care resource use in~     patients who have been prescribed either immediate-release (IR) hydrocortisone or~     modified-release (MR) hydrocortisone or prednisolone in the UK.~   "
42293|NCT03013153|"~     Laparoscopy colon surgery is accepted worldwide in the recent years. But there is still~     argument on the effect of laparoscopy rectal surgery. Laparoscopy has advantages on showing~     the inferior mesenteric artery (IMA), protection of autonomic nerve, low rectal anastomosis,~     and total mesorectum excision. However, debate on the level of IMA ligation and debonding of~     splenic flexure never ends. This study is going to give a clear and definite answer to how~     and why surgeons should deal with the IMA in laparoscopy rectal surgery，base on the 3D~     reconstruction of IMA and identification of IMA perfusion types.~   "
42294|NCT03013140|"~     Whether the usage of non-invasive arterial blood pressure monitor to guide fluid therapy in~     caesarean section can effectively reduce the incidence of hypotension and fetal~     complications.~   "
42295|NCT03013127|"~     This is a phase II, single arm, open-label, interventional trial of pembrolizumab (MK-3475)~     in patients with osteosarcoma who have experienced disease relapse or progression after at~     least one line of systemic treatment, and who are not eligible for curative surgery.~   "
42296|NCT03013114|"~     Primary immune thrombocytopenia (ITP) is a disorder caused by autoantibody-mediated platelet~     destruction and decreased platelet production. It has been reported that refractory ITP is~     closely related to long-lived plasma cells (PCs), which are resistant to glucocorticoids,~     conventional immunosuppressive and cytotoxic drugs, irradiation and B-cell depletion~     therapies.~      Proteasome inhibition bortezomib is one of the most promising therapeutic approaches to~     target PCs, since this strategy has been shown to efficiently eliminate multiple myeloma~     cells, that is, transformed PCs. It also has been successfully used in SLE-like mice,~     experimental autoimmune MG rats and experimental hemophilia-A mice that develop anti-factor~     VIII antibodies in preclinical models by depleting both short-lived and long-lived PCs.~     Additionally, treatment with bortezomib resulted in a rapid clinical response in a patient~     with refractory thrombotic thrombocytopenic purpura associated with the depletion of~     inhibitory autoantibodies against ADAMTS13, a metalloproteinase that cleaves the von~     Wille-brand factor, which is produced by plasma cells. Hence, the elimination of autoreactive~     PCs by proteasome inhibitors might represent a new treatment strategy for~     autoantibody-mediated diseases.~      To date, refractory ITP is lacking of effective treatments and these findings encouraged us~     to conduct a study of bortezomib in management of ITP with high anti-platelet antibodies~     level. Data from this study may provide some idea of bortezomib in the treatment of ITP.~   "
42297|NCT03013101|"~     This is a multi-center, open-label, phase 2 study evaluating the humanized anti-PD-1 antibody~     JS001, as a monotherapy in patients with locally advanced or metastatic melanoma who have~     failed in routine systemic treatment.~   "
42298|NCT03013088|"~     This is a clinical study aimed at demonstrating the safety and product performance of the~     SoundBite Crossing System. The study shall demonstrate that the SoundBite Crossing System can~     facilitate passage of a standard guidewire through a Chronic Total Occlusion (CTO) located in~     the lower extremity arteries without major adverse events related to SoundBite device~     utilization.~   "
42299|NCT03013075|"~     The investigator hypothesize that High Spinal Anesthesia (HSA) by its effect on attenuation~     of stress response, decrease in pulmonary vascular resistance, myocardial protection and~     positive myocardial oxygen balance will cause improvement in right ventricular function. So~     far there is no study that has evaluated the effect of HSA anesthesia on the right~     ventricular function, hence the investigator planned this study to compare the effect of HSA~     on the right ventricular function in patients with mitral valve disease with moderate to~     severe pulmonary hypertension planned for mitral valve replacement surgery.~   "
42301|NCT03013049|"~     Vitiligo is a complex disease causing a selective, often progressive, loss of functioning~     melanocytes from epidermal basal layer resulting in white patches on the skin and~     occasionally mucosae. Worldwide prevalence of vitiligo is around 1% whereas in India it is~     around 3-4% ranging from 0.46% to 8.8%.~      Etiopathogenesis of vitiligo is multifactorial consisting of genetic, immunological and~     environmental factors. Environmental and genetic factors act in concert to destroy~     melanocytes. Reactive oxygen species (ROS) play important roles in vitiligo pathology,but the~     autoimmune pathogenesis has been proposed as one of the main causes of vitiligo.~      Surgical methods, mainly transplantation of non cultured epidermal cell suspension are~     effective treatment for stable vitiligo. Transplantation of autologous noncultured epidermal~     cell suspension and non-cultured dermal cell suspension in combination (a mode of cellular~     grafting technique) is a novel surgical method for the treatment of vitiligo. Cytotoxic CD8+~     ( cluster of differentiation 8+) cells in vitiligo perilesions may dictate the fate of~     transplantation, and strategies against CD8+ T cell activation might be beneficial for~     patients undergoing melanocyte transplantation. Mesenchymal cells could inhibit T cell~     proliferation and induce T cell apoptosis. Bartsch first identified and characterized dermal~     mesenchymal cells (DMCs). They have a multi-lineage differentiation potential into~     adipocytes, osteocytes and chondrocytes.Vitiligo patients' autologous melanocytes~     transplantation efficiency may be predicted by perilesional skin-homing CD8+ T cell~     activities, and the immunoregulatory DMCs might be used as auxiliary agent to improve the~     efficacy.~      This pilot study is planned to compare transplantation of autologous noncultured epidermal~     cell suspension v/s its combination with non-cultured dermal cell suspension as a novel~     method in vitiligo surgery in stability of vitiligo with regards to extent of repigmentation,~     color matching of repigmented area, patient satisfaction and adverse events if any. This is~     the first study using transplantation of autologous noncultured epidermal cell suspension and~     non-cultured dermal cell suspension in combination as a new modality in vitiligo surgery.~   "
42302|NCT03013036|"~     Aim of our study is to evaluate the predictive value of ultrasonographic (USG) measurement of~     thyrohyoid distance for difficult intubation and determination of optimal endotracheal tube~     size by using USG in pediatric patients undergoing elective surgery.~   "
42303|NCT03013023|"~     This randomized controlled trial will use a longitudinal repeated-measures design to examine~     the effects of two interventions, behavioral support interventions and a parent-infant~     transactional program, on parents' stress, PPD and sleep quality, parent-infant interactions,~     and their preterm infants' stress (saliva cortisol levels), sleep patterns, emotional~     regulation, and neurobehavioral developmental outcomes from 7 days to 2 years corrected age.~   "
42304|NCT03013010|"~     Although the incidence of gastric cancer has been substantially declining for several~     decades, it is still the sixth most common cancer and the fourth most frequent cause of~     cancer death worldwide. Surgery is still the only curative option for gastric cancer.~     However, most patients are unable to undergo surgery because of late stage, unresectable~     disease. The prognosis for these patients is very poor. Although the Magic trial showed that~     perioperative chemotherapy can increase the rate of curative surgery and significantly~     improve overall survival in patients with operable gastric or lower esophageal~     adenocarcinomas, no pCR events were reported in this trial. The intervention arm in PREACT~     consists of pre-operative chemotherapy, pre-operative radiochemotherapy, surgery and~     post-operative chemotherapy. The control arm consists of pre-operative chemotherapy, surgery,~     and post-operative chemotherapy. The primary purpose of PREACT is to investigate whether the~     addition of radiochemotherapy to chemotherapy is superior to chemotherapy alone in the~     pre-operative setting in improving disease free survival in patients with locally advanced~     gastric or esophagogastric junction adenocarcinoma.~   "
42305|NCT03012997|"~     Patients undergoing Open Cardiac Surgery will be randomized into two groups. Group I will be~     ventilated with 40% Fio2 during induction, surgery and in Postoperative care unit. Group II~     will be ventilated with 100% Fio2 during induction and with 60-70% ( determined according to~     the arterial blood gas sample results) during surgery and in Postoperative care unit.~      Hemodynamic parameters ( systolic arterial pressure, diastolic arterial pressure, heart rate~     ), Arterial blood gas samples ( PaO2, PaCO2, pH, Oxygen saturation, Lactate), and pre and~     post cardiopulmonary bypass Superoxide dismutase and malonyl aldehyde levels.~   "
42306|NCT03012984|"~     Delirium is a frequently occurred cerebral complication in elderly patients after surgery,~     and its occurrence is associated with worse outcomes. Sleep disturbances is considered to be~     one of the most important risk factors of postoperative delirium. Previous studies showed~     that, for elderly patients admitted to the ICU after surgery, low-dose dexmedetomidine~     infusion improved the quality of sleep and decreased the incidence of delirium. The~     investigators hypothesize that, for elderly patients after cancer surgery, dexmedetomidine~     supplemented analgesia can also decrease the incidence of delirium, possibly by improving~     sleep quality. The purpose of this multicenter, randomized controlled trial is to investigate~     the impact of dexmedetomidine supplemented analgesia on the incidence of delirium in elderly~     patients after cancer surgery.~   "
42307|NCT03012971|"~     A majority of the elderly patients undergo surgery for malignant tumors. For these patients,~     postoperative tumor recurrence and metastasis are main factors that worsen long-term~     outcomes. The investigators hypothesize that dexmedetomidine supplemented analgesia in~     elderly patients after cancer surgery may help to maintain immune function and improve~     long-term outcomes, possibly by relieving stress and inflammatory response, improving~     analgesic efficacy and sleep quality, and reducing delirium incidence.~   "
42308|NCT03012958|"~     The purpose of this study is to learn more about new noninvasive ways of detecting lung~     disease in US Military personnel and people who worked as contractors during military~     operations in Iraq and Afghanistan. This study is looking at conducting a type of breathing~     test called the lung clearance index (LCI) test which is being investigated as a potential~     noninvasive way to detect the type of lung disease that may be seen in symptomatic deployers~     retuning from Iraq and Afghanistan.~   "
42309|NCT03012945|"~     Surgical resection is one of the most important treatments for malignant tumor; on the other~     hand, tumor recurrence and/or metastasis are the major reasons of treatment failure. The~     outcome after surgery mostly depends on the balance between the immunity of human body and~     the capability of implantation, proliferation and neovascularization of the tumor.~     Preclinical and retrospective studies suggest that anaesthetic techniques and drugs may~     affect the long-term prognosis in patients undergoing cancer surgery. The investigators~     hypothesize that epidural anesthesia-analgesia may improve the long-term outcome of the~     elderly patients who are scheduled to undergo major thoracic and abdominal surgery for the~     treatment of malignant tumor.~   "
42310|NCT03012932|"~     The proposed study will examine the implementation of a Human Papilloma Virus (HPV)~     self-sampling intervention for under screened LBQ women living in South Florida. The study~     will enroll participants to receive the self-sampling intervention in community venues. The~     purpose of this study is to pilot the self-sampler for feasibility and acceptability within~     this underserved population.~   "
42311|NCT03012919|"~     Rivers et al. laid the foundation for modern hemodynamic and fluid management by establishing~     goal directed therapy (GDT) for the treatment of sepsis using fluid and inotropic and~     vasoactive agents. There have been many subsequent protocols to improve outcome in the~     operating room or in the ICU. These are mainly passive decision support systems. Active~     clinical decision support systems using fluid and pharmacologic agents to improve~     intraoperative hemodynamics are not really found.~      The investigators developed an active clinical decision support system based on an~     institutional GDT-protocol using fluid, vasopressors and inotropes using the LiDCOrapid~     device.~      The goal of the study was to check the feasibility of an active clinical decision support~     system to optimize hemodynamics during high risk vascular surgery based on the principles of~     GDT implementing fluid, vasopressors and inotropes.~   "
42312|NCT03012906|"~     Patients undergoing percutaneous coronary intervention (PCI) with stent implantation and~     requiring chronic anticoagulation for atrial fibrillation (AF) with a CHA2DS2-VASc >1 are~     required to receive triple antithrombotic therapy . This triple therapy includes dual~     antiplatelet therapy with clopidogrel and aspirin in combination with an oral anticoagulant~     with either a vitamin K antagonist (VKA) or an oral anticoagulant (NOAC).~      Recently NOAC, inhibiting the IIa (dabigatran) or Xa (rivaroxaban and apixaban) in the~     coagulation cascade have demonstrated non inferiority compared to VKA to prevent~     thrombo-embolic events in non-valvular AF for patients with a CHA2DS2-VASc >1 .~     Interestingly, NOAC are associated with a reduced fatal bleeding rate compared to VKA.~     Overall they seem to result in a lower bleeding rate compared to VKA in association with~     antiplatelet agents.~      Recently European guidelines regarding patients requiring chronic anticoagulant therapy and~     undergoing coronary stent implantation have been updated. However they are based on an expert~     consensus because of the scarce data available.~      These guidelines advocate the combination of dual antiplatelet therapy with clopidogrel and~     aspirin in combination with the lower dose of OAC or VKA with a target INR between 2 and 2.5~     . The triple therapy should be prescribed for 1 to 6 months depending on the bleeding and~     thrombotic risk and the clinical setting. In patients with high bleeding risk the guidelines~     suggest that a sole antiplatelet agent could be used in addition to anticoagulation following~     the WOEST study . In the recently published ESC guidelines on the management of atrial~     fibrillation, despite the lack of new data, the expert advocate triple therapy followed by~     dual antiplatelet therapy in most patients for 12 months.~      The recently published PIONEER study reinforced the possibility of the use of rivaroxaban in~     these patients. In this trial including ACS and not ACS patients undergoing PCI rivaroxaban~     15 mg in addition to a P2Y12 ADP receptor antagonist was associated with less clinically~     relevant bleeding compared to triple therapy with VKA- aspirin and clopidogrel and similar~     efficacy .~   "
42313|NCT03012893|"~     To determine the accuracy of two techniques (transverse scan and sagittal scan) using~     ultrasonography to identify C7 spinous process compare to the fluoroscope (standard~     technique)~   "
42314|NCT03012880|"~     This phase II trial studies how well ixazomib citrate, lenalidomide, dexamethasone, and~     daratumumab work in treating patients with newly diagnosed multiple myeloma. Ixazomib citrate~     may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~     Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to~     stop the growth of cancer cells, either by killing the cells, by stopping them from dividing,~     or by stopping them from spreading. Monoclonal antibodies, such as daratumumab, may block~     cancer growth in different ways by targeting certain cells. Giving ixazomib citrate,~     lenalidomide, dexamethasone, and daratumumab may work better in treating patients with newly~     diagnosed multiple myeloma.~   "
42315|NCT03012867|"~     Different enteral nutrition formulas are tested on their effect on glucose homeostasis in~     critically ill medical patients.~   "
42316|NCT03012854|"~     This study compares the clinical efficacy of safety of circular myotomy and full-thickness~     myotomy guided by peroral endoscopic in treatment of incision length of ≤7cm and of ≥7cm in~     achalasia patients.~   "
42317|NCT03012841|"~     To demonstrate safety and effectiveness of the Arctic Front Advance™ and Freezor MAX® Cardiac~     CryoAblation Catheters for the treatment of drug refractory recurrent symptomatic persistent~     atrial fibrillation.~   "
42318|NCT03012828|"~     This study will investigate the effect of a single oral dose of moxidectin on the QT interval~     associated with moxidectin plasma concentrations.~      The effect of moxidectin on other ECG intervals, and on safety, will also be assessed, as~     will preliminary pharmacokinetics and metabolism~   "
42319|NCT03012815|"~     The current gold-standard for the management of alcohol withdrawal syndrome (AWS) is~     symptom-triggered administration of benzodiazepines. This method of treatment has several~     drawbacks that have been described in the literature. Thus benzodiazepine sparing agents have~     been evaluated for use in AWS. One of these agents that has not only shown benefit for AWS~     but also benefits on complete abstinence, reducing a return to heavy drinking, and cravings~     is gabapentin. In clinical practice at Mayo Clinic gabapentin is used for this purpose. Due~     to the limited reports of the safety and efficacy of a protocol involving gabapentin for AWS,~     a study to compare gabapentin to symptom-triggered lorazepam will be completed.~   "
42320|NCT03012802|"~     Short title POWER Audit~      Methods 60 days national (Spain) audit of postoperative complications following elective~     gastrointestinal surgery within an enhanced recovery after surgery (ERAS) protocol.~      Research sites Hospitals undertaking elective lower gastrointestinal surgery. Objective To~     provide detailed data describing post-operative complications and associated mortality; and~     length of stay.~      To provide detailed data describing adherence to ERAS protocol and its association to~     morbidity.~      Number of patients Not specified. All eligible patients undergoing surgery during the study~     month. Inclusion Criteria All adult patients (aged ≥18 years) undergoing lower~     gastrointestinal elective surgery within an ERAS protocol during the 60 day study period.~      Statistical analysis Univariate analysis will be used to test factors (patient, surgical, and~     ERAS related) associated with surgical complications, length of stay (LOS) and in-hospital~     death. Single and multi-level logistic regression models will be constructed to identify~     factors independently associated with these outcomes and to adjust for differences in~     confounding factors. A stepwise approach will be used to enter new terms. A single final~     analysis is planned at the end of the study.~      Summary statistics with post hoc Bonferroni corrections will be used to assess possible~     dose-response dependence in percentage of patients with postoperative complications and LOS.~      Proposed Start Date A 60 day period between 2017~      Proposed End Date~      Data collection will end by September 2017~      Study Duration Six months~   "
42321|NCT03012789|"~     The purpose of this study is to evaluate the effect of different surgical resections (R0, R1,~     R2) on circulating NET transcripts (PCR score or NETest). A drop in circulating NET levels~     will be correlated with surgical excision. Secondly, variation of circulating NET transcripts~     will be correlated to NET recurrence to test whether this analysis may constitute an early~     predictive marker of disease relapse.~   "
42591|NCT03009266|"~     The overall aim of this study is to determine whether non-invasive imaging with myocardial~     contrast echocardiography using can provide information on the presence and spatial extent of~     recent myocardial ischemia by non-invasive echocardiographic imaging.~   "
42322|NCT03012776|"~     The purpose of this trial is to assess whether the Total Posterior Spine System (TOPS System)~     is more effective than transforaminal lumbar interbody fusion (TLIF) when used to stabilize a~     single lumbar level (L2 - L5) following surgical decompression in patients diagnosed with (1)~     at least moderate lumbar spinal stenosis, and (2) Grade 1 spondylolisthesis (or~     retrolisthesis), and (3) thickening of the ligamentum flavum or scarring of the facet joint~     capsule.~      Success will be assessed by means of a composite endpoint that measures improvement in in~     patient reported outcomes and the absence of any major device related complications.~   "
42323|NCT03012763|"~     The purpose of this study is to determine pharmacokinetics of the probe-drugs sulfasalazine,~     given in 240 ml non-caloric water and paracetamol, fexofenadine and valsartan after oral~     administration, given in 240 ml non-caloric water, in 240 ml caloric drink or in 240 ml~     grapefruit juice prior to ingestion and to visualize the localization and to measure the~     filling volume of stomach, small intestine as well as ascending, transverse and descending~     colon by T2-weighted magnetic resonance imaging after oral administration of 240 ml water~     (non-caloric water), after administration of 240 ml caloric drink and after administration of~     240 ml grapefruit juice.~   "
42324|NCT03012750|"~     Microcirculation should be assessed before and after tibial bypass surgery by intraoperative~     fluorescence angiography. According to this, the direct and the indirect angiosomes should be~     compared according to the individual microcirculatory improvement.~   "
42325|NCT03012737|"~     An uncontrolled feasibility study on using mouth piece ventilation in palliation of dyspnea~     in subjects with incurable advanced disease. Subjects are recruited from a local Hospice and~     from oncology ward. The main outcomes are the compliance of the subjects with the treatment~     and alleviation of dyspnea during the treatment period.~   "
42326|NCT03012724|"~     The purpose of the study is to demonstrate that the efficacy and safety of deep brain rTMS,~     (Transcranial Magnetic Stimulation) H7-Coil treatment as add on treatment, is as good as the~     FDA cleared, H1-Coil, in subjects with major depressive disorder that have been previously~     unsuccessfully treated with antidepressant medications.~   "
42327|NCT03012711|"~     This study is an evaluation of the effects of a Neuromuscular training program on hip~     strength and core stability. It is a randomized clinical trial evaluating pre and post~     scores.~   "
42328|NCT03012698|"~     The current study aims to test the safety of Repeated Magnetic Stimulation (RMS) treatment~     for dry eye. Patients will be asked to undergo a one-time treatment with Epitech Corneal~     Magnetic Stimulation Device on one eye. Changes will be monitor for over a study period of 3~     months.~   "
42329|NCT03012685|"~     Most people will experience a psychologically traumatic event, such as a life-threatening~     accident, at some point in their life. In the initial days after such an event, it is common~     to be haunted by intrusive memories: image-based memories of the event that spring to mind~     unbidden. Intrusive memories can be distressing in their own right, but are also a hallmark~     symptom of post-traumatic stress disorder (PTSD).~      Sleep is important for many functions involved in how people perceive, respond to and~     remember events, including stressful/traumatic events. Studies with patients who have~     experienced traumatic events indicate that sleep disturbances in the first weeks post-trauma~     are associated with later PTSD symptoms. However, in a previous study with healthy volunteers~     exposed to experimental trauma (film footage), those who were sleep-deprived in the first~     night, compared to those who slept, had fewer intrusive memories in the following week. This~     raises the question of how sleep in the first night, but also the first week, after real-life~     trauma is related to subsequent intrusive memories and PTSD symptoms.~      The current study is an observational study of patients recruited from a hospital emergency~     department after a traumatic event. After completing brief baseline questionnaires in the~     emergency department, participants will be asked to fill in a daily diary of their sleep and~     intrusive memories over the following week. Post-traumatic stress symptoms, anxiety and~     depression will be assessed by post/online at one week and two months. Participants will be~     telephoned after two months to complete an interview to assess PTSD symptoms and an optional~     feedback interview.~      This clinical study will be the first to assess the relationship between sleep in the first~     night and week, and intrusive memories and mental wellbeing after real-life trauma. Findings~     may have implications for developing simple sleep-based preventive treatments after trauma in~     the future.~   "
42330|NCT03012672|"~     This randomized pilot trial studies how well higher or lower dose cladribine, cytarabine, and~     mitoxantrone work in treating medically less fit patients with newly diagnosed acute myeloid~     leukemia or myeloid neoplasm. Drugs used in chemotherapy, such as cladribine, cytarabine, and~     mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet~     known whether giving cladribine, cytarabine, and mitoxantrone at higher or lower dose may~     work better in treating patients with newly diagnosed acute myeloid leukemia.~   "
42331|NCT03012659|"~     The purpose of this study is to assess the impact of a provider counseling training on~     patient contraceptive behaviors and satisfaction in a clustered randomized trial among 10~     Planned Parenthood health centers.~   "
42332|NCT03012646|"~     This is a multicenter, single-arm trial to evaluate the safety and efficacy of inhaled~     treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with~     Chronic Obstructive Pulmonary Disease (COPD).~   "
42333|NCT03012633|"~     During liver transplantation (LT), hyperfibrinolysis is one of the most important~     modification of haemostasis. It is associated with t-PA and protein C increased activity.~     Hyperfibrinolysis is frequent, hardly predictable and associated with major bleeding. The~     diagnostic of hyperfibrinolysis with standard laboratory tests (euglobulin lysis test, t-PA,~     PAI-1 and D-dimers dosages) does not provide an answer in a delay compatible with the~     clinical practice in the operating room.~      The Lysis Timer is a device developed by Hyphen-Sysmex in collaboration with SD Innovation~     and Charleroi University Hospital (Belgium). It allows the implementation of the Global~     Fibrinolytic Capacity, or GFC test, in a complete system associating i) the reagents for in~     vitro triggering of the clot and its lysis (contact system activators, t-PA, thrombin and~     calcium), ii) the signal acquisition by the Lysis Timer (able to convert the analogic signal~     of the absorbance modifications related to clot formation into a numeric signal) and iii) a~     dedicated software treating the numeric signal to define clot lysis time.~      The GFC test, using t-PA to shorten signal acquisition times, is particularly adapted to the~     diagnosis of hyperfibrinolysis with PAI-1 collapse, of which LT is an example.~   "
42334|NCT03012620|"~     This is a Phase 2, non-randomised, open-label, multicentric study to investigate the efficacy~     and safety of pembrolizumab monotherapy in 6 cohorts of patients with specific rare cancers~     who have unresectable locally advanced or metastatic disease, which is resistant or~     refractory to standard therapy, or for which standard therapy does not exist, or is not~     considered appropriate, and for which no other experimental treatment options are available,~     in order to identify subsets of patients that may benefit from treatment~   "
42592|NCT03009253|"~     The purpose of this study is to find the best neoadjuvant therapy for pancreatic~     adenocarcinoma.~   "
42335|NCT03012607|"~     Adherence to antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP) are critical to~     the success of HIV treatment and therapeutic prevention. No accurate, objective point-of-care~     test is available to monitor adherence to either ART or PrEP. The inability to accurately~     identify poorly adherent patients will lead to more HIV infections (from failed PrEP and~     non-suppressive ART), more drug-resistant virus (selected by failing ART), and unnecessary~     switching to costly second- or third-line ART (when first-line regimens with virologic~     efficacy but non-adherence are stopped inappropriately). To address this critical knowledge~     gap, the investigators have developed a novel point-of-care test to detect the presence of~     tenofovir—the most common drug in both ART and PrEP treatments worldwide—in fingerprick blood~     or urine as an objective measure of ART and PrEP adherence.~      Our central hypothesis is that the pharmacokinetics of tenofovir in blood and urine will~     support point-of-care tenofovir detection as an objective measure of adherence, and that our~     point-of-care tenofovir assay will have the ability to discriminate different drug adherence~     levels. The investigators will test our central hypotheses by pursuing the following two~     specific aims: (1) To assess our novel point-of-care tenofovir (TFV) assay in whole blood and~     urine specimens within a controlled pharmacokinetic study of HIV-negative adults receiving~     tenofovir disoproxil fumarate (TDF) with low, moderate, and perfect adherence; and (2) To~     validate our novel point-of-care tenofovir (TFV) assay on blood and urine specimens using an~     existing biorepository from a real-world clinical HIV prevention study.~      This work is innovative because it develops an entirely new category of rapid diagnostic~     testing for monitoring ART and PrEP adherence at the clinical point of care. Our rapid assay~     will help clinicians identify patients in need of more adherence counseling, which when~     implemented will prevent HIV acquisition, emergence of drug resistant virus, and unnecessary~     ART regimen switching—measures that will improve national HIV programs and help preserve the~     global supply of an effective HIV medication.~   "
42336|NCT03012594|"~     This is a human research study looking at the effectiveness of Lanreotide (study medication)~     in treating small bowel motility disorders. It is similar to a natural hormone somatostatin~     that is produced in the body in the stomach, duodenum, pancreas and brain. Somatostatin is a~     growth hormone-inhibiting hormone. Lanreotide is a man made hormone and is a long acting~     medication that is given once a month. It is marketed with a trade name Somatuline Depot.~     It is given deep subcutaneously (deep within the layers of the skin) in the superior external~     quadrant of the buttock. Injection site will be alternated on subsequent injections.~   "
42337|NCT03012581|"~     This is a Phase 2, non-randomised, open-label, multicentric study to investigate the efficacy~     and safety of nivolumab monotherapy in 6 cohorts of patients with specific rare cancers who~     have unresectable locally advanced or metastatic disease, which is resistant or refractory to~     standard therapy, or for which standard therapy does not exist, or is not considered~     appropriate, and for which no other experimental treatment options are available.~   "
42338|NCT03012568|"~     This is a clinical investigational plan (CIP) for the Clinical Study to Confirm MRI Safety~     and Effectiveness Using SJM Cardiac Rhythm Management Systems (ASSURE MRI). This study~     intends to enroll patients who meet standard bradycardia or tachycardia indications and have~     already been implanted with one of the SJM device/lead combinations listed in this protocol.~     The objective of this study is to confirm the safety and effectiveness of each of the four~     SJM device/lead combinations in an MRI environment. This clinical investigation is sponsored~     by St. Jude Medical.~   "
42339|NCT03012555|"~     There are approximately 90,000 individuals in the United States with sickle cell disease~     (SCD). Studies have shown that up to 98 percent of patients with Sickle Cell Disease have a~     vitamin D deficiency, defined as a 25-hydroxyvitamin D level (25(OH)D) less than or equal to~     20 ng/mL. As a result, of low bone density, patients may develop osteonecrosis, chronic~     inflammation and related pain. This study will be coordinated with patients' regularly~     scheduled visits for medical care and will require patients to submit blood sample at the~     start of the study and at 3, 6, 9, AND 12 month visits. Patients will also be scheduled for a~     bone density measurement (DXA scan) at the start of the study and after 12 months of~     supplementation to assess for any bone re-mineralization. Thus, the main purpose of this~     study is to find the amount of nutritional vitamin D that needs to be taken by patients with~     sickle cell disease in order to correct vitamin D deficiency. The study will also test~     whether vitamin D supplements improve bone health and reduce inflammation.~   "
42340|NCT03012542|"~     Recent data suggest that diet in inflammatory bowel disease (IBD) may lead to both symptom~     control and disease remission. Historically certain diets have been recommended for patients~     with Crohn's disease during exacerbations despite lack of data supporting efficacy. The~     investigators propose to evaluate two such diets by randomizing 32 subjects with mildly to~     moderately active Crohn's disease to one of two diets that differ in the amount and type of~     carbohydrates and fiber. Subjects will remain on the diet for 8 weeks and will be evaluated~     for changes from baseline in inflammatory biomarkers, symptomatic disease activity, and the~     microbiome.~   "
42341|NCT03012529|"~     The purpose of this research study is to determine if rifampin, an antibiotic (a medicine~     that treats infections), is effective in treating osteomyelitis (infection of the bone) of~     the foot in diabetic patients. Despite use of powerful antibiotics prescribed over a long~     period of time, many diabetic patients remain at a high risk for needing an amputation of~     part of the foot or lower leg because the osteomyelitis is not cured. Some small research~     studies have shown that addition of rifampin to other antibiotics is effective in treating~     osteomyelitis in both diabetics and non-diabetics. However, because few diabetics with~     osteomyelitis have been studied, there is no definite proof that it is better than the usual~     treatments for diabetic patients. If this study finds that adding rifampin to the usual~     antibiotics prescribed for osteomyelitis reduces the risk for amputations, doctors will be~     able to more effectively treat many Veteran patients with this serious infection. Improving~     treatment outcomes is an important healthcare goal of the VA.~   "
42342|NCT03012516|"~     The aim of this study is to evaluate a one year intervention with physical activity on~     prescription (PAP) treatment for patients in a primary health care center setting versus an~     enhanced PAP-support with physiotherapist regarding physical activity (PA) level, metabolic~     health effects and health-related quality of life.~      One hundred ninety patients, 27-85 years, physically inactive, having at least one component~     of the metabolic syndrome and not responding with increased PA level after a 6-months~     PAP-treatment in primary health care centre are randomized to either enhanced support by~     physiotherapist (Intervention group) or continued ordinary PAP-treatment at the health care~     centre (Control group).~   "
42357|NCT03012321|"~     This is a biomarker preselected, randomized, open-label, multicenter, phase II study in men~     with metastatic castration resistant prostate cancer (mCRPC). Patients with tumors that have~     ATM, BRCA1 and/or BRCA2 mutations/deletions/loss of heterozygosity will be randomized in a~     1:1:1 fashion to each arm. Patients with mutations in noncanonical DNA repair genes including~     FANCA, PALB2, RAD51, ERCC3, MRE11, NBN, MLH3, CDK12, CHEK2, HDAC2, ATR, PMS2, GEN1, MSH2,~     MSH6, BRIP1, or FAM175A defects will be assigned to Arm IV with single agent olaparib.~   "
42343|NCT03012503|"~     Background: Neck pain effects a significant number of individuals and is commonly treated~     with chiropractic cervical manipulation. The temporary increases in neck pain following~     cervical manipulation may contribute to a lack of compliance with prescribed therapy that~     following this therapy which in turn commonly contributes to protracted symptoms. Topical~     menthol has previously been shown to decrease pain shortly following application. The purpose~     of this study was to determine if patients with mechanical neck pain who received topical~     menthol gel applied to their neck prior to cervical manipulation would have less pain and~     increased neck range of motion following cervical manipulation than patients who did not~     receive menthol.~      Methods: Patients, mean ages 35 years old, with non-radicular mechanical neck pain were~     randomly assigned to a control (n=31) or a treatment (n=29) group. Five minutes before~     cervical manipulation, controls received a placebo gel applied to their neck while the~     treatment group received a menthol containing gel (Biofreeze®) applied to their neck.~     Participants rated their neck pain on a 10-point scale prior to gel application (Pre) and at~     one minute (T1), 10 minutes (T2), 20 minutes (T3), and 30 minutes (T4) post cervical~     manipulation. Six measures of neck range of motion were assessed prior to topical~     applications of gel and at T1 and T4. ANCOVA repeated measures were performed to compare pain~     ratings and neck range of motion following manipulation while controlling for Pre measures.~   "
42344|NCT03012490|"~     The primary objective is to determine whether comprehensive remote follow-up in HF patients~     with CRT will reduce the combined endpoint of all-cause mortality or worsening heart failure~     hospitalizations, whichever comes first, when compared to basic remote monitoring, over a~     27-month follow-up.~   "
42345|NCT03012477|"~     This research study is studying a combination of drugs as a possible treatment for~     triple-negative breast cancer that has spread to other areas of the body. The names of the~     study interventions involved in this study are:~        -  Cisplatin~        -  AZD1775~   "
42346|NCT03012464|"~     Patients aging less than 45 years with rectal prolapse will undergo full pathologic and~     functional assessment to determine the underlying etiology.~   "
42347|NCT03012451|"~     The study aims to deliver a robust pre-post evaluation of the wellbeing impacts of an~     innovative, brief, and scalable psychosocial intervention, delivered to refugee youth living~     in urban settlements in Jordan. The study was conducted using two waves of data collection:~     the first featured an intervention and a matched control group, the second featured a full~     randomized control trial.~   "
42348|NCT03012438|"~     During surgery in which the thyroid is removed (thyroidectomy), the identification of~     parathyroid glands, that should be saved, can be challenging. Therefore, there is need for~     accurate intraoperative guidance. Earlier animal studies show that the parathyroid glands can~     be identified by the use of the Near Infrared Fluorescent dye Indocyanine green (ICG).~      Our hypothesis is therefore, that the use of ICG-based fluorescence imaging during thyroid~     surgery will provide real-time intraoperative visualization of the parathyroid glands.~      This prospective observational feasibility study aims to evaluate the feasibility of the use~     of ICG in identifying the parathyroid glands during thyroid surgery. 30 patients (age >18~     years) who are already regularly scheduled for thyroid surgery; i.e. patients undergoing~     total thyroidectomy are suitable for inclusion. In all patients, undergoing total~     thyroidectomy infrared fluorescence imaging, using a per-operative intravenous injection of~     7.5 mg ICG, will be tested on feasibility and imaging characteristics.~   "
42349|NCT03012425|"~     The other aim of this study is to determine which of those two treatments (acupuncture or~     cognitive behavioral therapy) works better for treating insomnia in Informal Caregivers of~     cancer patients.~   "
42350|NCT03012412|"~     The current study aims to test the efficacy a mindfulness based intervention for women facing~     fertility problems - the Mindfulness Based Program for Infertility (MBPI). MBPI comprises 10~     weekly group sessions of approximately 2 hours each, run in small groups of 10-15 women. The~     main goal of MBPI intervention is to reduce depressive and anxiety symptoms and promote~     infertility self-efficacy and acceptance and mindfulness skills. The MBPI is intended to~     develop willingness/acceptance through a process of contacting the present moment and be in~     touch with the unfolding experience in an open and non-judgmental way, particularly~     infertility-related experiences.~   "
42351|NCT03012399|"~     The goal of this clinical research study is to learn if it is possible to perform a~     relaxation method called hypnosedation before and during breast cancer surgery in order to~     avoid the need for general anesthesia. The safety of this procedure will also be studied.~   "
42352|NCT03012386|"~     This proposal will test the hypothesis that chronic treatment with sildenafil with and~     without the use of nitric oxide substrate, L-arginine, protects against fatty acid induced~     impairment of endothelial function, improves insulin-stimulated microvascular recruitment,~     insulin sensitivity and glucose uptake in CD36 rs3211938 G-allele carriers.~   "
42353|NCT03012373|"~     This is an open-label, randomized, 2-sequence, cross-over study evaluating the difference of~     efficacy between ear acupressure alone and ear acupressure plus electroacupuncture therapy~     both combined with methadone treatment services for heroin addicts.~   "
42354|NCT03012360|"~     Antimicrobial treatment could be beneficial in patients with ventilator-associated~     tracheobronchitis (VAT). The hypothesis of this study is that antibiotic treatment for VAT (3~     or 7 days), compared with no antibiotic treatment, would reduce the incidence of transition~     from VAT to ventilator-associated pneumonia (VAP).~   "
42355|NCT03012347|"~     To explore and quantify potential issues with application of a gel sunscreen in Outdoor Use~     testing, in a controlled indoor environment~   "
42356|NCT03012334|"~     This will be a randomized, single dose, double-blind, placebo-controlled, Latin-square design~     with 5-period (full) crossover study with participants randomized to treatment sequences.~     Participants will complete all 5 Periods.~      During each Period, participants will come to the clinical research unit (CRU) and remain~     overnight before being dosed with a single dose of either lasmiditan, alprazolam, or placebo~     in the morning. Cognitive testing and driving simulation will be conducted post dosing.~     Participants will have a washout of at least 5 days between each Period.~      This study is designed to test non-inferiority of lasmiditan doses relative to placebo, with~     an alprazolam test versus placebo to confirm the sensitivity of the simulator to detect~     treatment effects.~   "
42358|NCT03012308|"~     As part of cardiac and hemodynamic evaluation of patients, echocardiographic measurements~     allow indirect evaluation of left ventricular filling pressures (LVFP). These ultrasound~     parameters, including mitral valve doppler and mitral ring doppler (in particular the E / E~     'ratio), are well validated in medical cardiology and in some resuscitation patients. The~     measurement of filling pressures is an important daily element in the medical management of~     patients in intensive care, in particular on the hemodynamic and respiratory levels. No~     studies have evaluated the relevance of these markers in a postoperative context of cardiac~     surgery. Indeed, the surgery alters the cardiac function, which could modify the values of~     the echocardiographic parameters and their predictability. Left atrium pressure (LAP)~     directly reflects LVFP and is measured in cardiac surgical resuscitation by a surgically~     placed catheter as part of routine institutional care and will serve as gold-standard. To~     study the clinical significance of these LAP and LVFP values estimated by cardiac ultrasound,~     we will study their correlation with clinical and ultrasound signs of acute lung edema (ALE).~   "
42359|NCT03012295|"~     Monogenic hypertension, which follows the rules of Mendel's genetic law, is one of the most~     important causes of hypertension. Generally, patients occur hypertension in early age, have~     family history, and often manifest severe hypertension or refractory hypertension. At~     present, only a few hypertension centers of hospitals in China will help clinically difficult~     diagnosis hypertensive patients to test some selective genes, while most of other hospitals~     still perform diagnosis based on biochemical examination and clinical symptoms. Therefore, in~     order to provide better guidance for the diagnosis and treatment for hypertensive patients,~     this project aims to develop a single gene detection panel for genetic hypertension, so as to~     provide new diagnostic technology for early intervention, prevention and treatment of~     hypertension in clinics.~   "
42360|NCT03012282|"~     This pilot clinical trial studies how well computed tomography (CT) perfusion images work in~     assessing treatment response in patients with pancreatic cancer. Analyzing specific~     measurements on the CT perfusion images may help doctors better determine how a tumor~     responds to chemotherapy and/or radiation therapy and may help guide treatment for patients~     with pancreatic cancer.~   "
42361|NCT03012269|"~     This study aims to conduct a contrast study on the characteristics of functional and~     structural connectivity of neural networks of working memory in patients with acquired brain~     injury versus normal controls, using resting-state functional connectivity magnetic resonance~     imaging, task-specific functional magnetic resonance imaging and diffusion tensor imaging,~     combined with cognitive behavioral examinations. Another purpose is to reveal the~     characteristics of dynamic change of neural networks of working memory pre- and~     post-intervention in patients with working memory dysfunction.~   "
42362|NCT03012256|"~     Rationale:~      In Canada, home care clients are a large and expanding subgroup of medically complex older~     adults with relatively poor access to effective chronic disease management. They have double~     the emergency department utilization rate compared to nursing home residents or other older~     populations. The investigators previously published a case-finding tool (the Detection of~     Indicators and Vulnerabilities for Emergency Room Trips (DIVERT) Scale) that has been~     recommended for chronic disease management case-finding in home care. The investigators~     recently conducted a pilot trial in Niagara, Canada, of a targeted, person-centered model of~     supportive cardio-respiratory disease management.~      Objectives:~      The investigators will evaluate a cardio-respiratory disease management model in home care to~     manage symptoms and avoid emergency department use. A pan-Canadian, pragmatic~     cluster-randomized trial will be conducted by a collaboration of trial investigators and~     public home care providers (i.e., health regions).~      The main objective is to evaluate the effectiveness and preliminary cost-effectiveness of a~     targeted, person-centered cardio-respiratory management model.~      The main question is:~      P: Among home care clients experiencing cardio-respiratory symptoms (objectively targeted~     using the DIVERT Scale), I: can a guideline-based, feasible, multi-component/complex,~     cardio-respiratory management model, C: compared to regular care, O: reduce~     cardio-respiratory symptoms, reduce/postpone unplanned emergency department (ED) visits,~     reduce unplanned hospital use, improve patient activation, or improve health-related quality~     of life for clients, T: over a 6-month follow-up period from baseline?~   "
42363|NCT03012243|"~     In order to compare percutaneous cholecystostomy and leaving a drain in situ with~     percutaneous gallbladder aspiration we plan to undertake a double-blind randomized controlled~     trial.~   "
42364|NCT03012230|"~     This phase I trial studies the side effects and best dose of ruxolitinib phosphate when given~     together with pembrolizumab in treating patients with stage IV triple negative breast cancer~     that has spread to other places in the body. Monoclonal antibodies, such as pembrolizumab,~     may interfere with the ability of tumor cells to grow and spread. Ruxolitinib phosphate may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving~     pembrolizumab and ruxolitinib phosphate together may work better in treating patients with~     stage IV triple negative breast cancer.~   "
42365|NCT03012217|"~     This is a performance study to test the sensitivity and specificity of the BioFire FilmArray~     Respiratory Panel (RP) 2. The purpose of this study is to prospectively collect and test~     residual NPS specimens and generate performance data to support regulatory classification of~     the FilmArray RP2 as an in vitro diagnostic (IVD) in the US, European Union (EU), Canada, and~     other regions.~   "
42366|NCT03012204|"~     To compare the effects of various combinations between 6 hertz(Hz) rTMS & LFrTMS on the limb~     motor dysfunction due to cerebral vascular disease.~   "
42378|NCT03012048|"~     This project is a community-based randomized controlled trial designed to test the~     effectiveness of two point-of-use water treatment technologies to improve clean drinking~     water access, reduce enteropathogen burden, and improve child growth among children in~     Limpopo, South Africa.~   "
42379|NCT03012035|"~     This study evaluates the role of treatment success expectation in spider fearful individuals~     on the actual treatment success. Half of participants will have positive treatment success~     expectations, while the other half will have neutral treatment outcome expectations.~   "
42593|NCT03009240|"~     This phase I trial studies the side effects and best dose of pevonedistat when given together~     with decitabine in treating patients with high risk acute myeloid leukemia. Pevonedistat and~     decitabine may stop the growth of cancer cells by blocking some of the enzymes need for cell~     growth.~   "
42367|NCT03012191|"~     Recessive dystrophic epidermolysis bullosa (RDEB) is an incurable, devastating, inherited~     skin disease caused by mutations in the COL7A1 gene that encodes for type VII collagen (C7),~     the major component of anchoring fibrils (AFs), structures that mediate epidermal-dermal~     adherence. Thirty percent of RDEB patients have nonsense mutations. The investigators~     recently demonstrated in 5 such patients that intradermal and topical gentamicin induced~     read-through of their nonsense mutations and created robust and sustained new C7 and AFs at~     the dermal-epidermal junction (DEJ) of their skin and also stimulated wound closure and~     reduced new blister formation. No untoward side effects occurred. Herein, the investigators~     propose evaluating the safety and efficacy of intravenous gentamicin in these patients. In~     theory, this intravenous administration has the possibility of treating simultaneously all of~     the patients' skin wounds. The investigators also propose optimizing the concentration and~     manner of delivery of topical gentamicin. The unambiguous milestones will be increased C7 and~     AFs in the patients' DEJ, improved EB Disease Activity Scores, and absence of significant~     gentamicin side effects.~   "
42368|NCT03012178|"~     Based on the ACC/AHA guidelines for the management of mitral valve disease, quantifying the~     severity of mitral regurgitation is central to determining which patients are appropriate for~     correction of their mitral valve by surgery. Specifically, once the diagnosis of severe MR is~     made, patients are considered appropriate for mitral valve surgery in almost all clinical~     circumstances. However, there is a significant mortality and morbidity associated with mitral~     valve surgery The most common diagnostic tool to assess the severity of MR is~     echocardiography. Several studies have shown that echocardiography parameters used to~     quantify and qualify MR have high inter-observer and intra-observer variability, calling the~     accuracy of these parameters into question. Furthermore, studies have shown that there is a~     significant degree of discordance between echocardiography and MRI when assessing MR,~     particularly among patients referred for mitral valve surgery. In a recent study,~     quantification of mitral regurgitant volume MRI was found to be more accurate than~     echocardiography in patients who underwent mitral valve surgery. All 38 patients who~     underwent mitral valve surgery in this study were deemed appropriate according the ACC/AHA~     guidelines based on echocardiographic findings. However, more than 2/3rds of patients who~     underwent mitral valve surgery in this study did not have severe MR by MRI. Thus, we propose~     this prospective multicenter trial to assess: 1) the severity of MR by MRI in patients~     undergoing mitral valve surgery. 2) the impact of mitral valve surgery on quality of life and~     healthcare costs in the context of MR severity by MRI, 3) assess patient outcomes post~     surgery in the context of MR severity by MRI and 4) the likelihood of valve replacement vs.~     repair according to MR severity by MRI.~   "
42369|NCT03012165|"~     A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Phase 2b Evaluation of the~     Onset and Duration of ADX-102 Ophthalmic Drops (0.5% and 0.1%) Compared to Vehicle of ADX-102~     Ophthalmic Drops in the Conjunctival Allergen Challenge (Ora-CAC®) Model of Acute Allergic~     Conjunctivitis.~   "
42370|NCT03012152|"~     This non randomized study is a comparative study between standard conservative breast surgery~     and oncoplastic surgery as regard margin status and patient satisfaction.~   "
42371|NCT03012139|"~     This study is designed to gain a better understanding of the mechanisms leading to muscle~     wasting and metabolic abnormalities in skeletal muscle of cancer patients.~   "
42372|NCT03012126|"~     This project seeks to build on innovative strategies to optimize the care of low-income~     children with a BMI ≥ 85th percentile. To accomplish this goal, investigators will implement~     a new clinical-community intervention, theoretically grounded in the Integrated Clinical and~     Community Systems of Care Model, to address obesity through optimized screening and~     management known to be effective, e-Referrals, Healthy Weight Clinics, and the YMCA's Healthy~     Weight and Your Child weight management program (originally known as MEND). The study will~     examine outcomes for children that matter most to a broad group of stakeholders including~     parents, clinicians, and public health practitioners as well as inform the care of >7 million~     children with obesity covered by the Children's Health Insurance Program or Medicaid.~   "
42373|NCT03012113|"~     Obesity and type 2 diabetes (T2D) are emerging problems worldwide. In particular South Asian~     individuals (representing 20% of the world population) have an increased risk of obesity and~     related disorders. They are at higher risk for the development of T2D as compared to white~     Caucasians and develop T2D at a younger age and with lower BMI. The underlying mechanisms~     that might explain these ethnical differences have not been clarified or understood yet. As a~     consequence, treatment options are limited and unfocussed, and novel specific strategies are~     needed.~      Brown adipose tissue (BAT) has recently been discovered as a major player in energy~     metabolism in humans. In a process known as thermogenesis, BAT takes up fatty acids (FA) and~     glucose from the circulation and subsequently combusts FA and glucose into heat, thereby~     increasing energy expenditure and improving glucose and FA metabolism. Using~     18F-fluorodeoxyglucose (18F-FDG) (positron emission tomography/computed tomography) PET-CT~     scan analysis investigators have recently shown that South Asian individuals have less brown~     adipose tissue (BAT) than white Caucasians. This might suggest that they have a lower energy~     metabolism, which could underlie their increased predisposition for obesity and the~     development of T2D.~      Activation of BAT, for example by cold exposure, was shown to have beneficial metabolic~     effects in humans. Cold acclimatization can increase BAT volume, nonshivering thermogenesis,~     glucose uptake by BAT, as well as decrease fat mass in healthy young men. Therefore~     activation of BAT is considered as a novel therapeutic target in the treatment of obesity and~     T2D. As cold exposure is not the most desired therapeutic strategy for humans, current~     pre-clinical research focuses on pharmacological activation of BAT.~      β3-receptor agonists can be used to mimic sympathetic innervation of BAT. Our recent studies~     using mice with a human-like lipoprotein profile showed that treatment with a β3-receptor~     agonist decreased fat mass, improved dyslipidemia, increased insulin sensitivity and even~     attenuated the development of atherosclerosis. Likewise, the novel β3-receptor agonist~     (Mirabegron) has recently been shown to activate BAT in healthy young men as effectively as~     cold exposure. Therefore, ß3-receptor agonism would be a promising treatment option to~     activate BAT and enhance energy expenditure, especially for South Asians.~      Currently the most common way to visualize BAT in humans is by 18F-FDG PET-CT scan. However~     this method is both expensive and invasive, as it uses ionizing radiation. Recently, MRI,~     which has no radiation burden, has emerged as a novel method to visualize BAT in humans.~     Activation of BAT results in combustion of intracellular lipid stores, which eventually leads~     to a lower triglyceride (TG) content. MRI can measure TG content of tissue, and using MRI~     technology the activation of BAT can be quantified by the relative reduction in the TG~     content of BAT. The use of MRI to visualize and quantify BAT activity is a safe,~     cost-effective and innovative alternative to PET-CT, which has a potential to become a new~     gold standard in the nearby future.~      To investigate whether β3-receptor agonism has therapeutic potential to improve the metabolic~     phenotype of South Asians, investigators will perform a randomized cross-over study in which~     20 healthy young men aged 18-30 years with a lean body type (BMI <25 kg/m2) are included.~     Dutch South Asian individuals (n=10) and matched Dutch white Caucasian individuals (n=10)~     will participate in a cross-over study consisting of three different regimes.~      This study will investigate whether β3-receptor agonism has therapeutic potential to improve~     the metabolic phenotype of South Asians. The effects of a β3-receptor agonist on BAT activity~     in South Asians have never been studied before. Elucidating the effects of this β3-receptor~     agonist on BAT activity in South Asians might have major clinical implications, as it might~     result in the discovery of a potential novel treatment strategy to combat obesity and T2D in~     this especially vulnerable population.~   "
42374|NCT03012100|"~     This randomized phase II trial studies how well multi-epitope folate receptor alpha peptide~     vaccine, sargramostim, and cyclophosphamide work in treating patients with triple negative~     breast cancer. Vaccines made from a person's white blood cells mixed with tumor proteins may~     help the body build an effective immune response to kill tumor cells. Drugs used in~     chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Giving multi-epitope folate receptor alpha peptide vaccine, sargramostim, and~     cyclophosphamide may work better in treating patients with triple negative breast cancer.~   "
42375|NCT03012087|"~     The aim of this study is to pilot test a web-based, patient-centered educational program that~     encourages the patient to have an informed discussion about pain medication options with~     their emergency department (ED) provider.~   "
42376|NCT03012074|"~     This study will use mobile health technologies to provide everyday data to help patients and~     their care providers better understand illness dynamics and develop adaptive approaches to~     improve health outcomes in diabetes. Specifically, the study will identify strategies to help~     patients adapt using multiple types of self-generated diabetes-related data and help~     providers guide patients to better self-manage in real-time, when guidance is needed most.~   "
42377|NCT03012061|"~     This study is conducted to evaluate the effects of UMEC 62.5 microgram (mcg) and UMEC 31.25~     mcg on lung function versus placebo after 24 weeks of treatment. This study will provide~     important information regarding the efficacy and safety of UMEC when administered in a~     separate inhaler to subjects on a background of fluticasone furoate (FF). This is a Phase~     IIb, randomized, double-blind, placebo controlled study that will compare the efficacy,~     safety and tolerability of UMEC (62.5 mcg and 31.25 mcg) administered once-daily in subjects~     with asthma that is not well controlled. Eligible subjects will be requested to participate~     in the study for a maximum of approximately 31 weeks with 4 phases (pre screening,~     screening/run-in, randomization/treatment and safety follow-up). The total number of~     randomized subjects required is approximately 384, with 128 subjects randomized 1:1:1 to each~     of the 3 double-blind treatment arms.~   "
42594|NCT03009227|"~     The purpose of this study is to determine wether D3 lymph node dissection gives superior~     oncological outcomes compared to standard D2 lymph node dissection in colon cancer~   "
42380|NCT03012022|"~     The purpose of this research study is to investigate the role of chemical reactions, such as~     inflammation and oxidation, in the cause of cardiac dysfunction (the heart does not function~     properly). The investigators are interested in studying the various chemical pathways for~     cell damage to determine which are the most prevalent and/or most important. The~     investigators also want to determine whether waste products of oxidative damage or other~     chemicals can be monitored in the blood or urine and serve as an indication of the existence~     and severity of overall heart disease activity. The investigators further want to determine~     whether certain proteins, called enzymes, affect this cell damage, or whether the presence or~     absence of certain genes which create different forms of these enzymes correlate with the~     development of heart failure or cardiomyopathy (weakening of the heart muscle or a change in~     heart muscle structure) or other cardiovascular diseases.~   "
42381|NCT03012009|"~     Photodynamic therapy (PDT) is a well established treatment option for superficial non~     melanoma skin cancer, such as superficial basal cell carcinoma (sBCC) and Bowen Disease (BD).~     However, a limited uptake of the topically applied photosensitizer methyl aminolevulinate~     (MAL) may reduce its efficacy. Pretreatment with an ablative carbon dioxide (CO2) laser has~     recently been studied in order to enhance the skin penetration of this photosensitizer. This~     study compares the results of a full ablative and a fractional ablative CO2 laser mode as~     pretreatment of PDT in the management of sBCC and BD. The endpoints efficacy, pain,~     aesthetics and patient preference are investigated during twelve months of follow up.~   "
42382|NCT03011996|"~     Cohort 1~      To evaluate the pharmacokinetic interactions of CJ-12420 after multiple oral doses of~     CJ-12420 given alone or in combination with amoxicillin/clarithromycin in healthy subjects.~      Cohort 2~      To evaluate the pharmacodynamic profiles of CJ-12420 after multiple oral doses of CJ-12420 in~     combination with amoxicillin/clarithromycin in healthy subjects as compared to an active~     control group, i.e., pantoprazole in combination with amoxicillin/clarithromycin.~   "
42383|NCT03011983|"~     This study utilizes multimodal brain imaging to obtain quantitative biomarkers of brain~     injury and to improve understanding of the biological basis of brain pathology in adolescents~     with concussion. Adolescents with a concussion will undergo neuroimaging and neuropsychology~     assessments acutely and four months after injury.~   "
42384|NCT03011970|"~     The purpose of this study is to determine whether effects of intranasal oxytocin on amygdala~     response vary as a function of treatment dose and dose-test latency.~   "
42385|NCT03011957|"~     MATCH is an observation study of HIV-infected adults on effective antiretroviral therapy~     (ART) and demographically matched uninfected adults to evaluate muscle and aging.~   "
42386|NCT03011944|"~     A nutrition-focused QIP will be implemented as standard of care at select branches of the~     home health division of the health care system. The QIP will be comprised of three groups of~     patients, Group 1 will consist of hospitalized, at-risk/malnourished patients being~     discharged to home health, Group 2 will consist of outpatients at-risk/malnourished patients~     enrolled in home health and Group 3 will consist of SNF, at-risk/malnourished patients being~     discharged to home health. Groups will be followed for 90 days post enrollment. The QIP~     groups will be compared to historical controls, concurrent controls, and matched concurrent~     controls across other sites within the health system.~   "
42387|NCT03011931|"~     To study the correlation between simvastatin metabolism by the enterocyte and the histologic~     state of the intestine in treated celiac disease.~   "
42388|NCT03011918|"~     Falls and falls related injuries are considered one of the most adverse events that a patient~     can experience. Several assessment instruments to assess and mitigate risks for falls have~     been developed. However, these instruments have not addressed nutritional risk factors.~      Weight loss and low hemoglobin levels are key components of Malnutrition. Malnutrition in the~     hospital setting is a significant concern and may play a role as a fall risk factor.~      The World Health Organization (WHO) maintains a global anemia database. WHO has identified~     iron deficiency anemia, based on hemoglobin value alone as the most common, wide-spread~     nutritional deficiency worldwide. Anemia is present in 30% of the worlds population including~     industrialized nations.~      The consensus statement of the Academy of Nutrition and Dietetics / American Society of~     Parenteral and Enteral Nutrition simply defines adult under-nutrition as a continuum of~     inadequate intake along with a multitude of other factors. Weight loss occurs at multiple~     points along this continuum.~      this multiphase retrospective descriptive analysis hypothesizes that degree of weight loss~     and degree of Hgb decline may be fall risk factors.~   "
42389|NCT03011905|"~     Many patients have strong pain at brachial plexus block resolution after operations for~     distal radius fractures with a volar plate. This study investigates if a single dose of~     dexamethasone in addition to a standard pain regime have an effect on postoperative pain. The~     primary endpoint is difference in the highest pain score first 24 hours after surgery. The~     investigators will also look at pain scores and analgesics consumption first few hours after~     surgery and at different times up to 2 years after surgery.~   "
42390|NCT03011892|"~     The purpose of this study is to establish the efficacy of each strength of INCB018424 cream~     once daily (QD) or twice daily (BID) in subjects with atopic dermatitis as compared with~     vehicle cream BID.~   "
42391|NCT03011879|"~     The program is to improve STEMI medical care quality in China. With the documents issued by~     National Health and Family Planning Commission of the People's Republic of China, the program~     was initialed in at least 200 primary PCI capable hospitals together with hundreds of~     adjacent non-primary PCI capable hospitals in 15 provinces. STEMI patients with symptom onset~     within 30 days will be enrolled in 3 periods. In each period with 6-month interval, 30~     patients will be enrolled consecutively from each PCI-capable center initially and from~     non-primary PCI capable hospitals later, thus at least 18,000 STEMI patients from primary PCI~     capable hospitals will be enrolled and all of them will be followed up for 1 year. Key~     performance indicators (KPIs) in STEMI care will be collected using both national PCI online~     registry and a program STEMI online registry database for the purpose of improvement of~     medical care. Hospital KPIs rank report and problem-based resolution will be feedback to each~     hospital after data analysis in each period. Comparison of every two cross-sectional data~     (self) and within one cross-sectional (inter-hospital) data will be used to evaluate the~     improvement of medical quality.~   "
42392|NCT03011866|"~     Multilevel decompression and bone graft fusion is a most effective measure for treating~     degenerative lumbar spinal diseases. Yet, the surgery is commonly associated with large~     amount of perioperative blood loss and high demand for homologous blood transfusion.~     Tranexamic acid (TXA) has been proved as efficient in reducing the gross blood loss in~     various kinds of surgeries. However, high quality evidence of its efficacy and safety is~     still lacking in lumbar spinal surgeries. Besides, systemic use of TXA carries the risks of~     thromboembolic complications such as deep venous thrombosis and pulmonary embolism, thus the~     optimal drug delivery route of TXA remains undetermined. The aim of this study is to test the~     non-inferiority of topical TXA application to its intravenous use in multilevel decompression~     and bone graft fusion surgeries. A prospective, randomized, double-blind, head-to-head~     comparison study design will be adopted.~   "
42393|NCT03011853|"~     Observational cohort study of mid-to-long term survival of patients with acute on chronic~     obstructive pulmonary disease, analyzed per type of ventilation support provided during first~     24 hours in intensive care.~   "
42394|NCT03011840|"~     This study aims to understand the benefits of imparting pre operative instructions through~     written leaflets. The influence on the number of avoidable postponements and delay is also~     studied.The study is restricted to patients undergoing Head & Neck procedures under General~     Anaesthesia, at the minor OT complex at Tata Memorial Hospital~   "
42395|NCT03011827|"~     Thromboelastometry better assess coagulation than standard coagulation test in patients~     undergoing ortothopic liver transplantation. In a post-hoc analysis from a randomized study~     recently conducted by our group, presurgical values of MA10 Extem < 35 mm are highly~     predictive of RBC administration , with no further improvement over MA10 Extem >40 mm ;~     suggesting that MA10 Extem between 35-40 would be the optimal range to manage blood product~     administration. The aim of the study is to validate this result in a prospective cohort of~     patients submitted to ortothopic liver transplantation.~   "
42396|NCT03011814|"~     This randomized phase I/II trial studies the best dose and side effects of durvalumab and to~     see how well it works with or without lenalidomide in treating patients with cutaneous or~     peripheral T cell lymphoma that has come back and does not respond to treatment. Monoclonal~     antibodies, such as durvalumab, may interfere with the ability of cancer cells to grow and~     spread. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the~     growth of cancer cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Giving durvalumab and lenalidomide may work better in treating~     patients with cutaneous or peripheral T cell lymphoma.~   "
42397|NCT03011801|"~     This study evaluates Interpersonal Therapy (IPT) in the treatment of depression among~     pregnant women with elevated depressive symptoms. Half of the women will be randomized to~     receive IPT, and the other half will get Treat As Usual, provided via behavioral health in~     the hospital.~   "
42398|NCT03011788|"~     The aim of this randomized trial is to compare the proportion of patients achieving an~     adequate bowel preparation after a 1-day split-dose 4-liter PEG-based bowel preparation~     regimen (Golytely, Braintree Laboratory Inc, MA, USA) vs. the same regimen given on 2~     consecutive days in a population identified as high risk for an inadequate bowel preparation.~      2. Research Design: This study is a single-center prospective randomized study at the West~     Haven VAMC.~      3. Methodology:~        1. Primary endpoint: Adequate bowel preparation as defined by a Boston Bowel Preparation~          Scale (BBPS) score of 2 or 3 (on scale of 0-3) in all 3 colon segments (left,~          transverse, and right).~        2. Secondary endpoints: Adenoma detection rate, polyp detection rate, sessile serrated~          polyp/adenoma detection rate, patient tolerability of preparation using the validated~          Mayo clinic bowel prep tolerability questionnaire, adverse events potentially related to~          bowel preparation~      Patients scheduled for routine outpatient colonoscopy will be eligible if they are at high~     risk for poor bowel preparation,~   "
42399|NCT03011775|"~     Pioglitazone, a medication of thiazolidinedione group, is capable of triggering the~     peroxisome proliferator-activated receptors (PPAR-γ). Activation of receptor PPAR-γ regulates~     carbohydrate and lipid metabolism, immune and inflammatory responses in heart tissues.~      Our aim will to study the effect of pioglitazone on insulin resistance, the clinical course~     of atherosclerosis and coronary heart disease (CHD).~      The study will include 43 patients with coronary artery disease. Patients will be divided~     into the study group - 20 patients, in whom pioglitazone will be included in the combined~     therapy at a dose of 15 mg 1 time per day in the morning, and the control group - 23 patients~     receiving standard complex drug therapy over 6 months. Patients will be underwent clinical~     examination, ultrasound of neck vessels, study of carbohydrate and lipid metabolism.~      The end primary points of the study will be the onset of death due to myocardial infarction,~     coronary revascularization procedures (coronary artery bypass grafting (CABG) or percutaneous~     coronary intervention (PCI)), or hospitalization for acute coronary syndrome (ACS) or~     unstable angina (UA).~      Predefined secondary end points included carotic atherosclerotic leisure (carotic~     intima-media thickness, diameter of stenosis, presents of atherosclerotic plaque), systemic~     inflammation level (the level of C reactive protein), lipid metabolism (levels of serum total~     cholesterol, triglycerides, high and low density lipoproteins), level of insulin resistance (~     oral glucose tolerance test, blood glucose).~   "
42400|NCT03011762|"~     Sleep apnea is a condition in which the throat air passage closes during sleep and repeatedly~     interrupts breathing. The standard treatment of sleep apnea is air pressure applied to the~     nose, so-called nasal CPAP, but it is not suitable for all patients. Another treatment is to~     use a dental appliance while asleep. In this treatment, an appliance covers the upper and~     lower teeth and acts to pull the jaw forward, which opens the throat passage. This allows the~     patient to breathe normally.~      Dental appliance treatment does not work effectively in all patients. In order to identify~     those in whom dental appliance therapy will be effective, the study sponsor has invented the~     remotely controlled mandibular positioner, MATRx. The MATRx is an FDA cleared motorized~     dental appliance which is used overnight in hospital sleep studies and works by pulling the~     jaw outward under the control of a technician.~      In order to eliminate the need for an overnight in hospital sleep study, the sponsor has~     invented a new device that allows for the identification of individuals who are suitable~     candidates for dental appliance therapy from the comfort of the home. Like with MATRx,~     participants will sleep with a motorized mandibular positioner in place. But, it is~     controlled by a computer, rather than a sleep technician, making it a computer controlled~     mandibular positioner (CCMP). The feasibility and predictive accuracy of multi night testing~     using the CCMP will be evaluated through participation in this study.~      The sponsor has carried out two previous research trials leading to the development of the~     CCMP. The first established the predictive accuracy of the remotely controlled mandibular~     positioner at identifying candidates suitable for oral appliance therapy and their effective~     therapeutic setting. The second established the accuracy of the algorithms used by the CCMP~     to similarly identify successful candidates in a clinical setting. No significant problems~     were identified in conjunction with our previous research protocol, and no significant risks~     were identified. This third protocol is to establish the feasibility and accuracy of the CCMP~     when used in the home setting.~      The trial will utilize data collected over a series of nights to formulate a prediction of~     therapeutic outcome with an oral appliance. The prediction will be tested by comparing the~     degree of airway obstruction without treatment (from data collected prior to the study) to~     the degree of airway obstruction with oral appliance therapy. A custom fit oral appliance~     will be provided to participants as part of the trial.~      The purpose of the study is to test the predictive accuracy of the CCMP in identifying~     favorable candidates for oral appliance therapy and in determining an efficacious protrusive~     position. Another purpose is to evaluate the convenience and possibility of carrying out a~     multi-night CCMP study in the home.~      There are no known risks or side effects to the CCMP studies, to the home studies, or to the~     oral appliance therapy. It is possible that participants will have some discomfort during the~     nights of the CCMP studies but this will be transient and not cause any long term damage.~     Participants may experience soreness of the teeth or jaw joint during adjustment of the oral~     appliance by the dentist. There is no risk of jaw dislocation or problems with the~     temporomandibular joint (TMJ).~      Participants will have the benefit of receiving a dental appliance for treating their sleep~     apnea at no charge. This will be supplied to participants by a dentist who is an expert in~     this field. Participation in the study will also allow the further development and ultimately~     commercialization of the CCMP device which may help individuals who have sleep apnea.~      Dental appliance therapy is just one of two therapies for sleep apnea. If participants choose~     not to have the dental appliance therapy, they may wish to try nasal continuous positive~     airway pressure. Participants may withdraw at any time during the study without compromising~     their health care in any way. To withdraw, participants should simply notify one of the~     physicians or the research assistant. If the sponsor obtains new information that might~     affect an individual's willingness to participate in the study, they will be informed~     immediately.~   "
42401|NCT03011749|"~     The aim of the study is to investigate whether positron emission tomography (PET) using the~     tracer 18F-Fluorothymidine (FLT) can provide information on proliferative activity in bone~     marrow of patients receiving Radium 223 therapy and potentially be a predictive marker of~     hematological toxicity~   "
42402|NCT03011736|"~     This clinical trial studies the omission of intact parathyroid hormone testing during surgery~     in treating patients with primary hyperparathyroidism. Omission of intact parathyroid hormone~     testing during parathyroid gland removal may help patients with primary hyperparathyroidism~     to decrease their time under anesthesia, and decrease the overall time and cost of surgery.~   "
42403|NCT03011723|"~     This study evaluates the effect and process of individualized music therapy for home-dwelling~     persons with mild to moderate dementia. The music therapy is administered individually and~     includes a close caregiver. Memory of familiar music is found to be retained in persons with~     dementia. It is assumed to facilitate autobiographical memories and stimulate interaction~     with significant others. Based on time series analyses we will use statistical process~     control to evaluate when and how change occur.~   "
42404|NCT03011710|"~     Electronic cigarettes are battery-powered vaporizers which have a similar feel to tobacco~     smoking. They do not produce cigarette smoke but rather an aerosol, which is frequently~     referred to as vapor. E-cigarettes are marketed as less harmful alternatives to smoking. Use~     and awareness of these devices has grown exponentially in recent years, with millions of~     people currently using them.~      The benefits and risks of electronic cigarette use are uncertain. There is no research on the~     acute oral effects of electronic cigarette in the scientific literature and no hungarian~     epidemiological survey has been performed in this topic.~      Regulation of electronic cigarettes varies across countries in the European Union, ranging~     from no regulation to banning them entirely.~      The investigators research could help to integrate the regulation of this device in Hungary~     and in the EU as well.~      The measurement of acute oral effects of e-cigarette and a hungarian epidemiological survey~     would be novel in this topic.~   "
42405|NCT03011697|"~     Valvular heart disease (VHD) is becoming more and more frequent with the aging, which has~     brought a heavy burden to the world. However, the prevalence and prognosis of valvular heart~     disease are not so clear, especially in the developing countries such as China etc. Because~     of the slow and progressive nature of VHD, symptoms might not be too severe to be diagnosed~     on time. Our retrospective survey (Int J Cardiol. 2016 Nov 25) indicated that severe valvular~     diseases are very common in China. Hence, we design a prospective, observational cohort study~     to provide contemporary information on the prevalence, characteristics, risk~     stratification，cost-effective ,treatments and prognosis of Chinese hospitalised adult~     patients with valvular heart disease.~   "
42406|NCT03011684|"~     Iatrogenic infertility as a result of cancer treatment has a profound effect on long-term~     quality of life in survivors of reproductive-age cancers. Oocyte cryopreservation prior to~     cancer treatment has been associated with improved quality of life, with a potential ability~     to reduce long-term decision-related regret in cancer survivors. Though letrozole plus~     gonadotropin and and tamoxifen plus gonadotropin are currently routinely used worldwide in~     ovarian stimulation cycles for fertility preservation in patients with~     estrogen-receptor-positive breast cancer, it is not clear which of the two might lead to~     improved oocyte yield. Improved knowledge about the efficacy of these medications, with~     regard to oocyte yield, has the potential to significantly improve quality of life in~     reproductive-age breast cancer survivors.~   "
42407|NCT03011671|"~     This is a Phase I study that examines the rate of dose limiting side effects in patients with~     malignant astrocytoma treated with combination acetazolamide (ACZ) and temazolomide (TMZ).~     Eligible patients must have histologically proven newly diagnosed, O6-methylguanine-DNA~     methyltransferase (MGMT) methylated WHO grade III or IV astrocytoma and be planning to~     undergo treatment with standard adjuvant TMZ (after completing treatment with TMZ and~     ionizing radiation (IR)).~      During this study, patients will receive daily oral ACZ with TMZ. During each cycle, ACZ will~     be started on the day of TMZ initiation and continued for a total of 21 days.~   "
42408|NCT03011658|"~     Oral lichen planus (OLP) is a T-cell mediated chronic immunological disease directed to a~     still unknown antigen. It is a mucocutaneous and a psychosomatic disorder, with unknown~     prevalence rate; however studies suggest an incidence of 0.02 to 0.22% among the Indian~     population. 75% of patients with cutaneous lichen planus also experience oral lesions and may~     be precipitated or exacerbated by psychosocial stressors.~      In conditions like pain, anxiety and stress, many metabolic and endocrine changes occur in~     the body, the most common effect of which is increased cortisol level in blood. This hormone~     is a 21-carbon corticosteroid secreted by adrenal cortex and regulates the metabolism of~     carbohydrates, fats, proteins and water. Also known as stress hormone, cortisol is a decisive~     index in stressful situations.~      This study is intended to correlate the serum cortisol levels with anxiety and depression in~     patients with symptomatic oral lichen planus. This study attempts to evaluate psychological~     anxiety and depression in oral lichen planus subjects using Hospital Anxiety and Depression~     Scale ( HADS) and correlating with their serum cortisol levels.~      To understand and explore the etiopathogenesis for better management of oral lichen planus.~   "
42409|NCT03011645|"~     The purpose of this study is to identify gene variants that increase risk of cardiovascular~     disease (CVD) and type 2 diabetes, particularly genes related to stress factors.~   "
42410|NCT03011632|"~     The project is intended to be realised in two phases. In the first stage, a case control~     study will be performed. In the second phase, double-blind, placebo controlled study will be~     conducted. In the first phase 3 groups of children will be compare: i) a group of children~     suffering from chronic rhinosinusitis (CRS) (fulfilling the European Position Paper on~     Rhinosinusitis and Nasal Polyps (EPOS) criteria) and asthma (fulfilling the Asthma Predictive~     Index (API) criteria) (CRS+/asthma+, n=90), ii) a group of children suffering from CRS~     (fulfilling the EPOS criteria) but without asthma symptoms (negative API criteria)~     (CRS+/asthma-, n=30) and iii) a group of children without symptoms of CRS (negative EPOS~     criteria) and without asthma symptoms (negative API criteria) (CRS-/asthma-, n=30). In the~     second phase the effect of intranasal glucocorticosteroids will be assessed. The following~     research methods will be used: CRS-symptom score questionnaire (SN-5) and Childhood Asthma~     Control Test (cACT) questionnaires, skin prick test, spirometry, measurement of nitric oxide~     NO in exhaled breath (FeNO), taste perception test, eosinophil morphology assessment, ratio:~     glucose concentration in nasal secretion/serum glucose level, concentration of specific~     immunoglobulin (Ig) E, total immunoglobulin G (IgG) and immunoglobulin A (IgA), the~     proportion of innate lymphoid cells (ILC) and regulatory lymphocytes cells in the peripheral~     blood. Endoscopic examination of the upper airways will be performed and samples of the~     mucosa will be taken. The mucosal examination will be as follows: i) polymerase chain~     reaction (PCR) examination for the detection of the presence of viral and bacterial genetic~     material, ii) measurement of the expression of the various messenger ribonucleic acid (mRNA),~     iii) measurement of the expression of mRNA for the Epithelial-Mesenchymal Transition (EMT)~     genes and iv) percentage of ILCs.~   "
42411|NCT03011619|"~     Moderately to severely depressed subjects will be randomized to the Control Group, who will~     receive care as usual, or the CBT Group, who will receive care as usual in addition to the~     manualized course of Cognitive Behavioral Therapy (CBT).~   "
42437|NCT03011281|"~     The objectives of this single center, prospective, non-interventional inception cohort is to~     understand patient characteristics, general treatment patterns, effectiveness, and safety of~     Tofacitinib for rheumatoid arthritis patients in the real-world setting.~        1. To evaluate the baseline characteristics of Korean RA patients treated with Tofacitinib~        2. To evaluate the effectiveness and safety of Tofacitinib in clinical practice in Korean~          RA patients.~        3. To further evaluate safety, effectiveness and demographic characteristics of the~          patients treated with Tofacitinib matched with and compared to biologic DMARDs from the~          BIOPSY registry database.~   "
44951|NCT02978456|"~     The purpose of this study is to compare clinical outcomes between quantitative coronary~     angiography -guided and Intravascular ultrasound -guided strategy in patients with~     significant coronary artery disease undergoing sirolimus-eluting Orsiro stent implantation.~   "
42412|NCT03011606|"~     The toxicity of traditional prostate cancer therapies including radical surgery and external~     beam radiation is well known. This has prompted a move towards focal therapy where only the~     cancerous part of the prostate is treated.~      To date, studies have demonstrated very promising outcomes following focal therapy with the~     majority of men maintaining their urinary and sexual function after therapy.~      In a small proportion of men, disease recurs after focal therapy. The optimal treatment for~     men with recurrent disease after focal therapy is yet to be defined. Patients may undergo~     further focal therapy to the recurrent disease, undergo radiation therapy, whole-gland~     therapy using a minimally invasive approach such as High Intensity Focused Ultrasound (HIFU)~     or cryotherapy. Alternatively patients may undergo radical surgery where the whole prostate~     is removed.~      To date, the side-effects or toxicity of any treatment for recurrent prostate cancer after~     focal therapy has not been formally studied.~      Traditionally, the side effects of surgery and radiation therapy performed in patients that~     have already undergone previous prostate cancer treatment have been considerable with high~     rates of urinary incontinence and erectile dysfunction. However, as focal therapy leaves a~     significant area of the prostate untreated, the investigators believe surgery after focal~     prostate therapy will be associated with a much lower incidence of urinary and sexual~     dysfunction.~      The aim of the RAFT study is to characterise the side effects of prostate cancer surgery in~     men that have undergone prior focal ablation therapy. In addition, the investigators wish to~     perform a number of basic science studies to attempt to better understand why the patient has~     experienced recurrent prostate cancer after focal therapy.~   "
42413|NCT03011593|"~     This study assessed the effect of a nutrition support product on quality of life in adults~     with compromised gut function and malabsorption.~   "
42414|NCT03011580|"~     This Strategic Research Project is a translational proof-of-concept study that will determine~     whether vitamin D3 has potential to prevent recurrent tuberculosis (TB), as indicated by~     enhanced resolution of pulmonary inflammation detected using 18F-FDG PET-CT scanning. The~     extent of pulmonary inflammation detectable on PET-CT scanning is a validated biomarker that~     has previously been shown to predict risk of TB recurrence in patients taking anti-TB~     treatment. The investigators propose to explore whether vitamin D3 can enhance resolution of~     PET-CT-detectable pulmonary inflammation, on the basis of extensive preliminary data from in~     vitro studies and a Phase 2b clinical trial that the investigators have conducted, showing~     that high-dose vitamin D3 accelerates resolution of peripheral blood inflammatory responses~     in patients with pulmonary TB.~      Forty vitamin D-deficient patients who have completed 6 months' TB treatment, but who still~     have residual pulmonary inflammation detectable on PET-CT scanning, will be allocated to~     receive either an 8-week course of high-dose oral vitamin D3 supplementation or placebo~     during the study period. The extent of pulmonary inflammation on PET-CT scanning will be~     compared between intervention vs. control groups at 8-week follow-up.~      If the study shows a positive result, it will generate valuable proof-of-concept data that~     could be used to support an application to conduct a large phase 3 trial of vitamin D~     supplementation to prevent TB recurrence.~   "
42415|NCT03011567|"~     This study aims to evaluate whether NSAIDs (Non-steroidal antiinflammatory drugs)~     administered during the postpartum period influence blood pressure in women with hypertensive~     disorders of pregnancy. The study design is a prospective double blinded randomized control~     trial with participants randomized to receive postpartum analgesic regimens with and without~     NSAIDs.~   "
42416|NCT03011554|"~     VisionCare's Implantable Miniature Telescope (IMT, intraocular telescope or telescope) is~     indicated for monocular implantation to improve vision in eyes of patients at least 65 years~     of age with severe to profound vision impairment caused by bilateral central scotomas~     associated with end-stage age-related macular degeneration (AMD).~      Patients with end-stage AMD who have undergone bilateral cataract removal and intraocular~     lens placement are currently contraindicated for telescope surgery.~      These patients have no viable therapy available to improve their vision.~      The objective of the TES pilot study is to evaluate the safety and effectiveness of~     implanting the intraocular telescope for improving vision in patients with bilateral~     end-stage age- related macular degeneration who are pseudophakic.~   "
42417|NCT03011541|"~     This study will evaluate the use of autologous bone marrow derived stem cells (BMSC) for the~     treatment of retinal and optic nerve damage or disease.~   "
42418|NCT03011528|"~     Ewing's sarcoma and related tumours (ESFT) are rare tumours, with a peak incidence in the~     second decade of life. They start most often from bone, and are characterized by a specific~     translocation involving the so-called EWS gene. In one patient out of three, the staging~     procedures detect metastatic tumours at the diagnosis, most commonly in lungs, bones, and~     bone marrow.~      ESFT treatment strategy is multidisciplinary, combining primary chemotherapy, a local~     treatment, and consolidation chemotherapy.~      The primary metastatic dissemination is the most important prognostic factor, as the survival~     rate is around 70-75% for localized tumours, in contrast with less than 50% for patients with~     primary metastatic disease.~      Among primary metastatic patients, bone involvement and / or bone marrow strike markedly the~     prognosis of these patients. While the long-term survival of patients with isolated pleural~     pulmonary metastases is approximately 50%, whereas it is only from 0 to 25% in patients with~     bone marrow involvement.~      In 1999, the Intergroup EURO EWING built a new study protocol for patients with Ewing~     tumours. For the patients with primary extrapulmonary metastatic Ewing tumours (R3 patients),~     the protocol proposed a heavy induction chemotherapy, in order to propose a consolidation~     with high dose chemotherapy to a higher rate of patients. The high-dose Busulfan Melphalan~     chemotherapy (BuMel) was based on Busulfan (600 mg/m²) and Melphalan (140 mg/m²), with~     autologous peripheral blood stem cell (PBSC) support.~      Of note, for the full population of patients with metastatic disease, the 3-year EFS rate was~     27% (SD 3%), and the OS rate was 34% (SD 4%), with a median follow-up of 3.9 years after~     diagnosis, and a median survival time of 1.6 years.~   "
42419|NCT03011515|"~     The purpose of this study is to validate the diagnostic accuracy of a novel host-response~     based diagnostic tool for differentiating between bacterial and viral etiologies in adult~     patients aged 18 years and older with clinical suspicion of lower respiratory tract~     infections (LRTI)~   "
45216|NCT02975011|"~     A prospective study investigating the effectiveness and safety in lumbar stenosis patients~     receiving integrative Korean medicine treatment at 3 locations of Jaseng Hospital of Korean~     Medicine through assessment of pain, functional disability, and quality of life~   "
42420|NCT03011502|"~     Gut dysbiosis is an intestinal disorder that is characterized by accumulation of microbiota~     imbalance, host-microbiota crosstalk dysfunction and inflammation.~      As part of its clinical development, MaaT (Microbiota as a Therapy) Pharma is particularly~     interested in patients with Bone and Joint Infections (BJI). These patients are treated with~     antibiotics having significant consequences on their intestinal flora, causing intestinal~     discomfort, which can be manifested by diarrhea.~      MaaT Pharma wishes to carry out a clinical study, OSIRIS, in collaboration with Prof. Tristan~     Ferry, member and coordinator of CRIOAc (Centre de Référence des Infections~     Ostéo-Articulaires Complexes) Lyon, Center of Reference of Bone and Joint Infections (BJI).~     The objective of this study is to follow patients with treated BJI in order to characterize~     intestinal dysbiosis and the future relevance of an autologous Fecal Microbiota~     Transplantation (aFMT) intervention.~      To do this, patients will be monitored according to the current CRIOAc recommendations, with~     the aim of taking biological samples from patients at the same time as scheduled visits,~     routine monitoring patients. Only one additional consultation will be carried out 15 days~     after stopping the antibiotics in order to better evaluate the dysbiosis evolution.~      Thus biological samples (blood, stool, nasal, rectal) will be taken during the follow-up~     consultations over a period of 6 months.~   "
42421|NCT03011489|"~     Newborns with unilateral cleft lip/ palate will be treated pre-surgically by Vacuum formed~     aligners in order to evaluate its effect on Nasoalveolar complex.~   "
42422|NCT03011476|"~     Cholinergic deficiency in the brain can be related to gait and balance problems in Parkinson~     disease (PD). Recent clinical trials suggested a beneficial role of acetylcholinesterase~     inhibitors (AchEI) on gait in PD. In this study, the investigators are planning to study the~     influence of AchEI on a brain network for gait and balance in PD. As gait problem is~     prominent in postural instability and gait disturbance (PIGD) subtype, this study will focus~     on the patients with PIGD phenotype.~   "
42423|NCT03011463|"~     The purpose of the study is:~        -  to determine absolute bioavailability, input rates, distribution volume, renal and~          intestinal excretion of trospium in subjects with wild-type of SLC22A1 rs72552763 and~          rs12208357 and in subjects with homozygous variant alleles of SLC22A1 rs72552763 or~          rs12208357~        -  to determine absolute bioavailability, input rates, distribution volume and renal and~          intestinal excretion of trospium in subjects with wild-type alleles of SLC22A1~          rs72552763 and rs12208357 after co-medication of 300 mg of the OCT1- inhibitor~          ranitidine~        -  to determine absolute bioavailability, input rates, distribution volume and renal and~          intestinal excretion of trospium in subjects with wild-type alleles of SLC22A1~          rs72552763 and rs12208357 after co-medication of 500 mg of the P-glycoprotein- inhibitor~          clarithromycin~        -  to determine absolute bioavailability, input rates, distribution volume and renal and~          intestinal excretion of trospium in subjects with homozygous variant alleles of SLC22A1~          rs72552763 or rs12208357 after co-medication of 500 mg of the P-glycoprotein- inhibitor~          clarithromycin.~   "
42424|NCT03011450|"~     The purpose of this study is to evaluate the efficacy and safety of K-877 in adult patients~     With Fasting High Triglyceride Levels ≥500 mg/dL and <2000 mg/dL and Mild or Moderate Renal~     Impairment.~   "
42425|NCT03011437|"~     There are lack of endoscopic criteria for diagnosing Helicobacter pylori (H. pylori)~     infection by conventional white light imaging (WLI). Linked color imaging (LCI) is a newly~     developed endoscopy technique, which can diagnose mucosal lesions and H. pylori infection by~     enhancing color contrast of the mucosa. The aim of the study is to investigate the ability of~     LCI for diagnosing H. pylori infection compared with WLI.~   "
42426|NCT03011424|"~     Early postoperative extracorporal liver support therapy (ELS) as a tool to manage post~     hepatectomy liver failure (PLF).~      Post-operative liver failure (PLF) has been identified as a major risk factor leading to~     increased morbidity and mortality. The incidence of PLF varies largely between 0-30%, and may~     be accounted for the main reason of postoperative mortality related to liver surgery~     (reported figures ranging from 18 to 75 %).~      Currently, there are only a few treatment options for PLF, mainly restricted to the treatment~     of complications like bile leakage, infections as well as the prevention of further liver~     damage caused by e.g. thrombosis or haemorrhage as well as administration of liver toxic~     drugs. Recently the international study group on liver surgery (ISGLS) published criteria for~     a new definition of PLF which will greatly facilitate the comparison of results from future~     studies on a variety of aspects on liver failure.~      ELS by using the Molecular Adsorbent Recirculating System (MARS) is based on a modified~     haemodialysis that allows the removal of water-soluble and protein bound toxins over an~     albumin-coated high flux membrane against recycled exogenous albumin. Thus, MARS can support~     the compromised detoxification capacity of the liver as well as improve physiological~     parameters. This would offer the potential for temporary support for the harmed liver after~     liver resection allowing for a more uneventful recovery.~      For obvious reasons previous reports contain few patients, present heterogonous treatment~     groups and all suffer from lack of standardized treatment protocols. Few if any surviving~     patients, thus providing no evidence to encourage ELS as a possible treatment option for~     patients suffering of PLF. However, studies with defined patient populations and treatments~     according to a predefined standardised treatment protocol are warranted.~      Primary issues to be addressed:~        1. Can ELS be applied in an early phase of PLF?~        2. Is ELS safe and feasible for the treatment of PLF when practised according to a~          predefined protocol?~      Secondary issues to be addressed:~        1. The development of predictive laboratory-chemical markers of liver failure~        2. Indirect measures of portal flow and portal pressure~        3. Indocyanine green clearance (ICG) under ELS treatment~        4. Clearance of toxic products as assessed in aliquots taken from the dialysate~   "
42427|NCT03011411|"~     Pragmatic study comparing historical data from usual collection tools to medical~     administrative databases (local / national PMSI and CRF / SNIIRAM). There are 3 phases to the~     data collection:~        1. Collection of hospitalization data from the local PMSI and outpatient data from CRF~        2. Collection of hospitalization data in the national PMSI with a probabilistic matching~          between local and national PMSI data~        3. Collection of outpatient consumption data from SNIIRAM after matching of data from the~          national PMSI to the SNIIRAM.~   "
42428|NCT03011398|"~     The purpose of the Registry study is to observe the improvement in subject-reported clinical~     outcomes for percutaneous orthopedic procedures for treatment of musculoskeletal disorders.~   "
42438|NCT03011268|"~     The primary objective is to assess if discontinuation of anti- tumor necrosis factor alpha~     (TNF) treatment in ulcerative colitis patients in sustained clinical remission, with the~     option to restart treatment in the case of relapse, is non-inferior to continued anti-TNF~     treatment. Secondary objectives are to assess the efficacy and safety of restarting anti-TNF~     treatment after a relapse~   "
42607|NCT03009058|"~     During this open label study patients will receive IMM-101 in conjunction with a recognised~     standard of care for metastatic or unresectable cancer for the patient's specific tumour~     type.~      The primary objective of the study is to provide safety data for IMM-101 in combination with~     a number of selected standard of care regimens.~   "
42429|NCT03011385|"~     OBJECTIVE: The project aims at investigating of the effects of three types of planning~     (individual planning, collaborative planning, and dyadic planning) on physical activity among~     dyads.The influence of three planning interventions are compared with an active control~     condition, including physical activity education.~      PARTICIPANTS: The effects of the interventions are evaluated among dyads of two adults~     (partner-partner dyads). Adults forming dyads (e.g. two romantic partners, two relatives, two~     co-workers, two friends) who are in regular contact for at least one year will be enrolled. A~     minimum of 50 dyads enrolled into the each arm of the trial (a total of 200 dyads). The~     interventions consist of six planning sessions.~      DESIGN: The dyads are randomly assigned to one of four experimental conditions. The~     assessment of the main and secondary outcomes is conducted at the baseline, at 1 week after~     the first intervention session, at post-intervention (after six intervention sessions are~     completed), and at 6-, and 12-month follow-ups.~      OUTCOMES: Physical activity constitutes the main outcome, whereas health-related quality of~     life (HRQOL), body mass index, as well as the self-regulatory strategy called the use of~     planning (individual, dyadic and collaborative) are secondary outcomes.~   "
42430|NCT03011372|"~     The purpose of this study is to evaluate the efficacy and safety of INCB054828 in subjects~     with myeloid/lymphoid neoplasms with fibroblast growth factor receptor (FGFR) 1~     rearrangement.~   "
42431|NCT03011359|"~     Colon resection is one of the major surgery, the postoperative pain is so severe that it is~     necessary to use additional analgesics as well as a patient controlled analgesia (PCA). The~     most common pain management of this surgery is the intravenous (IV) PCA. If it is relatively~     insufficient amount of narcotic analgesics ,in the case of IV PCA, may be failed to reduce~     the pain effectively. Consequently, it may result in the a lot of rescue analgesics use,~     which leads to the adverse effects in patients who are very sensitive to narcotic analgesics.~     And the patient's satisfaction to the PCA may be low.~      For the recently released PCA instrument 'PAINSTOP', the investigators can specify the mode~     setting including total volume, flow rate (basal rate) per hour, bolus dose, and lock out~     time (LOT). Furthermore, this device can be set to optimize basal infusion (B.I), which is a~     new mode, so that the administered rate and amount of drug can be increased or decreased~     according to the patient's use of bolus button. Therefore, this PCA device can be implemented~     to the conventional mode, and added the function of automatically controlling the basal rate~     and administered amount of drug according to the use demand of the patient. However, since~     there are few studies related to this new mode of PCA, more research is needed in patients~     with postoperative pain.~   "
42432|NCT03011346|"~     Transcatheter aortic valve implantation (TAVI) is an established treatment option for~     patients with severe symptomatic aortic stenosis and at increased risk for surgical aortic~     valve replacement (SAVR). Many novel devices are currently being developed and established~     transcatheter heart valves undergo design reiterations to address limitations and reduce~     complication rates associated with the device and implantation procedure. However, device~     comparisons by use of randomized trials are scarce in particular for newer generation~     transcatheter valves. The aim of this study is to assess non-inferiority of the~     self-expandable Symetis ACURATE neo/TF in comparison to the balloon-expandable Edwards SAPIEN~     3 transcatheter aortic valve bioprosthesis with regard to early safety and clinical efficacy~     at 30 days.~   "
42433|NCT03011333|"~     This is a Phase 2B, randomized, assessor-blind, active- and saline placebo-controlled,~     multicenter study in subjects undergoing augmentation mammoplasty to evaluate the analgesic~     efficacy, safety, and pharmacokinetics (PK) of HTX-011 when administered via~     ultrasound-guided lateral and medial pectoral nerve block before surgery.~   "
42434|NCT03011320|"~     This study looks to enroll subjects with ovarian cancer who will be having standard of care~     surgery to remove ovarian cancer tumors. The main aim of this study is to be able to observe~     how EC1456 has been taken in and broken down inside tumors. The effect of EC1456 on the tumor~     will also be studied. This study will also help us compare the amount of EC1456 seen in~     tumors and how the tumors are imaged by the 99mTc-etarfolatide single-photon emission~     tomography (SPECT) or single-photon emission tomography with in-line x-ray computed~     tomography (SPECT/CT).~      All subjects will undergo a 99mTc-etarfolatide SPECT or SPECT/CT scan within 2 weeks prior to~     EC1456 administration.~      Individual subjects will then receive 1 of the following 2 doses of EC1456 pre-operatively:~        -  4 mg/m2~        -  8 mg/m2~      EC1456 will be administered at 1 of the following 2 time points:~        -  <8 hours before planned surgery~        -  48±4 hours before planned surgery~      Blood will be collected for pharmacokinetic (PK) studies right after EC1456 dosing and again~     right before surgery. At the time of surgery, tumor samples will be removed and sent to~     Endocyte for analysis.~   "
42435|NCT03011307|"~     The purpose of this study is to determine the effect of intrathecal oxytocin on speed of~     reduction in pain for the first 60 days after hip surgery.~   "
42436|NCT03011294|"~     Obstructive sleep apnea (OSA) is a common clinical condition associate with a negative impact~     not limited to the patients but also to the partner that sleep in the same bed. Is it~     reasonable to speculate that the partner suffer sleep deprivation, increased level of~     irritability, insomnia, fatigue, among others due to the loud snoring caused by the OSA~     patient. Although previous data reported impaired sleep quality in partners of patients with~     OSA, it is not clear in literature whether OSA promotes cardiovascular impact and if the~     treatment of OSA promotes some cardiovascular benefits in (the) partner beyond the~     improvements in the subjective and objective sleep. Thus, the main objectives of this~     randomized controlled study are: to evaluate the impact of three months of randomization~     (treatment with nasal CPAP or nasal strips) on the endothelial function, blood pressure~     (ambulatory blood pressure monitoring), sleep duration (wrist actigraphy for 1 week) and~     sleep quality (Pittsburgh Questionnaire) and the frequency of OSA in the bed partners of~     patients with moderate to severe OSA and a recent diagnosis of Metabolic Syndrome (MetS)~     according to the ATP III criteria derived from an ongoing randomized study conducted in our~     Institution.~   "
42564|NCT03009617|"~     Through the training and consultation program conducted via the web for health promotion,~     which is an important part of a school's healthcare, interactive communication methods~     between school nurses and students were provided. The results of the study showed that~     web-based education and counseling positively influenced health promotion behaviors of the~     students, and e-health literacy and their knowledge was increased.~   "
42439|NCT03011255|"~     Immunotherapy is now considered to be one of promising approaches for treating cancer.~     Radiation therapy has been to be a cornerstone treatment for unresectable advanced esophageal~     cancer. Radiation-induced mutation genes were identified as new sources of tumor associated~     antigens using exon sequencing and peptide microarray technologies. Epitope peptides for~     these targets are able to induce peptide specific cytotoxic T lymphocytes (CTL). In this~     clinical trial, investigators evaluate the efficacy and safety of peptide specific CTL~     therapy in combination with radiation therapy in treating patients with unresectable,~     advanced or recurrent esophageal cancer.~   "
42440|NCT03011242|"~     The Investigators will examine if DC-STAMP can serve as an early marker of TNFi response in~     PsA. Identification of such a biomarker would permit rapid transition to a new agent, a major~     treatment advance. TNFi are the most effective therapies in PsA, however, methotrexate is~     frequently initiated early in the disease course based on its significantly lower cost.~     Unfortunately, the efficacy of MTX has not been supported in clinical trials and up to 40% of~     patients do not respond to TNFi therapy. Moreover, valid biomarkers to predict MTX or TNFi~     responses are currently unavailable. This study may also provide the first data on the~     comparative efficacy of MTX and TNFi using clinical, Power Doppler Ultrasound (PDUS) and~     biomarker outcomes.~   "
42441|NCT03011229|"~     The purpose of this study is to compare the diagnostic accuracy of a novel endoscopic~     ultrasound (EUS) biopsy needle to the current standard EUS needle.~      The investigators hypothesize that with the SharkcoreTM needle a diagnostic yield of 90% is~     possible for subepithelial lesions (SEL) within the Gastrointestinal (GI) tract versus 60%~     yield with the current needle.~   "
42442|NCT03011216|"~     The present study examines whether a computerized cognitive control training as compared to a~     placebo (fake) training will reduce the frequency of depressive rumination in depressed~     individuals. Rumination has been identified as a major risk factor for the onset and~     recurrence of depressive episodes and it has been suggested that it is linked to deficits in~     cognitive control functions. It is thus expected that training cognitive control will reduce~     the frequency of rumination as well as ameliorate its detrimental effect on negative mood~     states.~   "
42443|NCT03011203|"~     The investigators will study if acute nutritional ketosis in adult GSD IIIa patients can~     boost muscle mitochondrial function in vivo.~   "
42444|NCT03011190|"~     Borderline personality disorder (BPD) is the most prevalent personality disorder in young~     community population whose most severe complication is suicide. Pharmacotherapy should not be~     used as the primary treatment for BPD as the benefits are unclear. Psychotherapy is the main~     treatment for people with BPD and the current recommendation is adapting available~     comprehensive treatments to develop easier and briefer therapies that are also effective.~     Iconic Therapy is an innovative option whose good clinical results should be validated on a~     clinical trial.~   "
42445|NCT03011177|"~     To assess the efficacy and safety of Teneligliptin and Linagliptin in the type 2 DM patients.~   "
42446|NCT03011164|"~     Some researches have found that gait posture velocity have influence on kinematic parameters.~     However, how the gait velocity and posture will influence kinematic parameters remain~     unclear. In addition to walking, running is one of the most daily activities of people. The~     purpose of this research is to find out the influence of gait velocity and running to~     kinematic parameters . To do this, it will provide a reference for future prospective studies~     or investigations and make us fully understand the impact of gait velocity and running to~     kinematic parameters of gait.~   "
42447|NCT03011151|"~     Gastrointestinal (GI) dysfunction affects up to 50% of medical and surgical critically ill~     children. GI dysfunction, specifically gastric dysmotility and loss of epithelial barrier~     integrity, is associated with significant morbidity in critical illness. The mechanisms~     underlying GI dysfunction in critical illness are not well understood. GI dysfunction in~     surgery and critical illness has been associated with inflammation. There is evidence to~     suggest the protease-activated receptor 2 (PAR2) is a link between inflammation and GI~     dysfunction. PAR2 is a G-coupled receptor present throughout the GI tract. PAR2 mediates GI~     motility and epithelial barrier integrity. PAR2 is activated by PAR2 agonists, specifically~     GI serine proteases and zonulin, released under conditions of inflammation. In this study the~     investigators will examine the relationship between inflammation and PAR2 activation by PAR2~     agonists and subsequent GI dysfunction in pediatric critically ill surgical patients. The~     overall hypothesis of this study is that PAR2 activation by PAR2 agonists, GI serine~     proteases and zonulin, released due to inflammation results in gastric dysmotility and loss~     of epithelial barrier integrity. In this study, the investigators will examine whether PAR2~     agonist expression is increased and correlates with GI dysfunction in critically ill surgical~     pediatric patients. This proposal fills a knowledge gap in the understanding of mechanisms~     for GI dysfunction in critical illness, and will be applicable to all surgical and medical~     critically ill children.~   "
42448|NCT03011138|"~     Previous reports have the evidence implicating gait velocity may affect kinematic parameters.~     However, how the gait velocity will influence kinematic parameters remain unclear. The~     purpose of this research is to find out kinematic characteristics among different gait~     velocity. To do this, it will provide a reference for future prospective studies or~     investigations and make us fully understand the impact of gait velocity.~   "
42449|NCT03011125|"~     This is a single center, randomized, double-blind, dose-escalation, placebo-controlled phase~     1 clinical trial. This study will determine the safety and side-effect profile of an~     investigational dexlansoprazole injection after single intravenous administration in healthy~     Chinese adults.~   "
42450|NCT03011112|"~     There is little study focusing on kinematic parameters in the assessment of the symptomatic~     and functional severity of knee osteoarthritis (KOA). The purpose of this study is to~     evaluate the correlations between kinematic parameters and the severity of symptoms and~     functions in patients with KOA.~   "
42451|NCT03011099|"~     The purpose of this study is to investigate whether robotic exoskeleton training can improve~     walking performance after SCI as compared to conventional physical therapy.~   "
42452|NCT03011086|"~     The etiology of OSMF is considered to be multifactorial. However, Role of autoimmunity had~     been suggested as one of the factors but remains unproven.~      The present study is undertaken to evaluate the presence of auto antibodies in OSMF patients~     to pave a way for new arena of treatment with the etiology of this persistent condition~   "
42453|NCT03011073|"~     Paris Saint Joseph hospital has just acquired a new echocardiography EPIC . This new system~     has image processing and left ventricular function quantification software which are~     different from the precedent model Philips IE33.Left ventricular function quantification and~     myocardial distortion are the main medical examination influencing doctor's decisions.~      EPIC can evaluate and quantify the cardiac ejection fraction via new software. Myocardial~     distortion quantification software also has been modified with new cut off and different~     calculation method.~      The aim of this study is to compare the quality of images and the quantification of cardiac~     ejection fraction with these new software in order to choose the more reliable and~     reproducible for patient.~   "
42454|NCT03011060|"~     This study evaluates whether sequential neo-adjuvant chemotherapy plus surgery followed by~     Capecitabine could achieve additional benefits over traditional postoperative chemotherapy.~     In the study group, patients that do not achieve pathological complete response(pCR) will~     receive sequential neo-adjuvant chemotherapy followed by Capecitabine. In the control group,~     patients will be treated with postoperative adjuvant chemotherapy.~   "
42455|NCT03011047|"~     Aim of this study is to assess the efficacy of endoscopic trans-maxillary surgical approach~     versus traditional trans-orbital surgical approach (control group) in orbital blow out~     fractures in terms of postoperative clinical and digital radio-graphical assessments.~   "
42456|NCT03011034|"~     The main purpose of the study is to evaluate the efficacy (transfusion independence [TI]) of~     talacotuzumab (JNJ-56022473) or daratumumab in transfusion-dependent participants with low or~     intermediate-1 risk Myelodysplastic Syndrome (MDS) whose disease has relapsed during~     treatment with or is refractory to Erythropoiesis-Stimulating Agent (ESAs).~   "
42457|NCT03011021|"~     The purpose of this study is to investigate the safety and therapeutic effect of ex-vivo~     expanded umbilical cord blood regulatory T cells adjunct with Liraglutide on autoimmune~     diabetes.~   "
42458|NCT03011008|"~     The purpose of this study is to investigate the therapeutic effect of Liraglutide on~     autoimmune diabetes.~   "
42459|NCT03010995|"~     The goal of this project is to evaluate the nicotine induced acute cardiovascular changes in~     E-Cigarette users and also study the mechanism involved particularly with vascular~     impairment.~   "
42460|NCT03010982|"~     This is a Phase 1, open-label, two-part study designed to characterize the PK of an IV dose~     of approximately 12 µg tazemetostat that contains approximately 500 nCi of [14C] tazemetostat~     and the ADME of an oral dose of 800 mg tazemetostat that contains approximately 400 µCi of~     [14C]-labeled tazemetostat in three subjects with B-cell lymphomas or advanced solid tumors.~   "
42461|NCT03010969|"~     The aim of the clinical study is:~        1. to examine the association between postoperative endothelial function, indirectly~          measured by reactive hyperemia index, and major adverse cardiovascular events including~          myocardial injury and cardiac death within 30, 90 and 365 days of acute abdominal~          surgery.~        2. to examine the association between postoperative endothelial function, indirectly~          measured by reactive hyperemia index, and non-cardiovascular complications including~          non-cardiac death within 30, 90 and 365 days of acute abdominal surgery.~        3. to examine the importance of the postoperative blood glucose level and the pulmonary~          function for postoperative complications and death within 30, 90 and 365 days of acute~          abdominal surgery.~        4. to examine the association between postoperative endothelial function, pulmonary~          function and blood glucose level~        5. the qualitative part of the study will examine the postoperative subjective symptoms~          including acute and chronic pain, quality of recovery and functional status, depressive~          thoughts and post-traumatic stress disorder.~   "
42462|NCT03010956|"~     Arterial stiffness is associated with increased risk for cardiovascular disease. Moreover,~     the integrity of endothelial glycocalyx plays a vital role in vascular permeability,~     inflammation and elasticity. The purpose of this study is to investigate changes in arterial~     stiffness and endothelial glycocalyx thickness in patients with poorly controlled diabetes~     mellitus type 1 or type 2 after glycemic control by optimal medication.~   "
42463|NCT03010943|"~     Feasibility and tolerance study of virtual reality headset for brain mapping during brain~     awake surgery.~   "
42464|NCT03010930|"~     The purpose of this study is to determine how repeated dietary exposure to umami taste~     affects umami taste perception, hedonics, food preferences, and satiety. Healthy adult~     subjects will consume a low glutamate vegetable broth daily for one month, where the~     experimental group's broth is supplemented with the umami-rich stimuli of monosodium~     glutamate (MSG) and the control group's low glutamate broth is matched for sodium (NaCl).~      The investigators hypothesize that repeated dietary exposure to umami taste will:~        1. diminish umami suprathreshold intensity perception and hinder the ability to~          discriminate varying MSG concentrations~        2. decrease liking of umami-rich foods and shift preferences upwards towards more intense~          umami stimuli~        3. decrease satiation and decrease the satiating effect of a test meal~   "
42465|NCT03010917|"~     This project represents a first step in examining the potential use of fish oil for the~     treatment of alcohol use disorder (AUD). The investigators will be testing for attenuation of~     alcohol-induced sedative and stimulant effects, as well as cognitive effects and cerebellar~     effects in healthy social drinkers.~   "
42466|NCT03010904|"~     This study aims to investigate differences in digestion rates and gastrointestinal problems~     caused by pasteurized; pasturized and homogenized as well as UHT-treated homogenized cow's~     milks in healthy adults by diary of symptoms, blood glucose and triacylglycerol levels and~     plasma cytokine levels.~   "
42512|NCT03010306|"~     Building on an intervention for early child development from the SPARK Center in Boston,~     Socios En Salud (SES) pilot tested CASITA a community-based package to screen and treat~     young children (ages 1-3 years of age) diagnosed with neurodevelopment risk and delay in~     Carabayllo, Lima, Peru. Ministry of Health CHWs identified children with developmental delays~     within the clinics and community and delivered a structured early intervention that included~     parent coaching and social support. In order to test the hypothesis that CASITA improves~     early child development, caregiver, and home environment, dyads received either nutrition~     supplements alone, nutrition + CASITA early child development sessions individually, or~     CASITA in a group of 10 dyads.~   "
42467|NCT03010891|"~     The proposed 2-year study has two specific aims: (1) to examine the effects of a bundle of~     supportive interventions on preterm infants' stress (salivary cortisol and~     dehydroepiandrosterone [DHEA] levels and physiological signals of infant distress), sleep,~     and physical activity in the NICU, and (2) to explore the relationships among preterm~     infants' salivary cortisol and DHEA levels, physiological signals of infant distress, sleep,~     and physical activity. This randomized controlled trial will adopt a longitudinal~     repeated-measures design to examine the effects of bundled supportive interventions on~     preterm infants' stress (salivary cortisol and DHEA levels [using ELISA kit] and~     physiological signals of infant distress [using bedside electrocardiographic monitors]),~     sleep and physical activity (using ankle actigraphy) during their NICU hospitalization.~     Preterm infants (N=120) meeting the study criteria will be randomly assigned to one of two~     conditions: (1) control condition: usual NICU care + positioning + gentle touch +routine~     kangaroo mother care (KMC) < 20 minutes; (2) experimental condition: the bundle of supportive~     interventions (usual NICU care +positioning + gentle touch + modulating infant states +~     facilitated tucking + non-nutritive sucking + oral sucrose+ routine KMC > 45 minutes. Outcome~     variables will include infants' biological responses to stress (salivary cortisol, salivary~     DHEA, and physiological signals of infant distress), sleep patterns, and physical activity.~   "
42468|NCT03010878|"~     This was a randomized control trial of a yoga and self-management intervention for~     individuals with chronic pain. Participants were assigned to either a wait-list control group~     (self-management only), or a yoga intervention (self-management and yoga). Self-management~     education session occurred monthly within the community. Group yoga intervention was~     delivered two times a week with a specifically designed program that was progressively more~     difficult. Assessments were then administered pre and post intervention, and a~     semi-structured interview was completed following the intervention. Quantitative and~     qualitative data were then compared between groups.~   "
42469|NCT03010865|"~     The purpose of this grant is to evaluate the efficacy of sodium butyrate as a novel treatment~     for cognitive deficits in schizophrenia (SZ). The aims will be to evaluate its effects on~     improving symptoms and functioning in SZ, and the relationship of the drug's clinical effects~     to epigenetic and inflammation related biochemical changes.~   "
42470|NCT03010852|"~     Postoperative (PO) hypoventilation, atelectasis and hypoxemia after bariatric surgery are~     common and multifactorial, contributing to prolonged oxygen (O2) therapy after surgery and~     even at hospital discharge. Incentive spirometry (IS) is recommended postoperatively but its~     success in preventing postoperative atelectasis and hypoxemia (POH) heavily depends on~     patient compliance with IS effort and frequency. The investigators hypothesize that a focused~     education preoperatively on IS for POH and intensive monitoring of patient compliance with IS~     therapy in the early postoperative period shortens postoperative oxygen therapy, decreases~     POH episodes, and improves respiratory outcomes after bariatric surgery, compared to patients~     receiving standard of care.~   "
42471|NCT03010839|"~     During cardiac surgery with cardiopulmonary bypass , injury occurs to the heart muscle and~     the lung.The heart and lung injury is a serious complication ,which increases both mortality~     and morbidity of cardiac surgery .Remote ischemic preconditioning(RIPC) with transient upper~     limb ischemia/reperfusion is a novel, simple, cost-free,non-pharmacological and non-invasive~     strategy.Recent some trials suggested that RIPC could provide myocardial protection by~     reducing serum cardiac biomarkers,however, more recent multicenter studies[9-11] had failed~     to show the protective effects of RIPC with respect to the troponin release and lung injury.~      Remote ischemic preconditioning (RIPC) is reported to have the early-phase and delayed-phase~     organ protective effects, whether the modified RIPC protocol induced repeatedly has the~     cardiopulmonary protective effect is still uncertain.~   "
42472|NCT03010826|"~     The neural circuits in our brains require a layer of insulation in order to transmit signals~     in a rapid and efficient fashion. This insulation is called White Matter and is comprised of~     a specific type of brain cell called an oligodendrocytes. Damage to brain white matter occurs~     following injury and in disorders like Multiple Sclerosis and results in sensory, motor, and~     cognitive problems. Currently there are no effective medical therapies to promote brain~     repair and reduce disability following damage to white matter. In this project, we hope to~     change the situation by encouraging the brain itself to generate new oligodendrocytes and~     thus new white matter. Our first step is to find measures sensitive to white matter growth.~   "
42473|NCT03010813|"~     This is a prospective, single center, multispecialty study that aimed to evaluate the~     clinical feasibility and safety of single port surgery and NOTES (mainly transanal and~     transoral surgery) using a novel single port robotic system.~   "
42474|NCT03010800|"~     This study will test the acute efficacy of an investigational device (Yoni.Fit) in a clinical~     trial of women with incontinence in a standardized set of challenges performed with and~     without the device in place.~   "
42475|NCT03010787|"~     A multi-part study to investigate the safety, tolerability and local and systemic~     pharmacokinetics of V565~   "
42476|NCT03010774|"~     Currently, all patients in the hospital are woken up throughout the night to check for vital~     signs, no matter how sick they are. The investigators are doing this study to determine~     whether skipping routine vital sign checks at night improves participant sleep quality and~     satisfaction without increasing the risk of adverse events.~   "
42484|NCT03010670|"~     Among different social cues from the environment, the eyes constitute a very salient source~     for initiating social interaction or communication. Interestingly, previous work from our~     (Prinsen et al., 2016) and other labs demonstrated that direct eye contact between two~     individuals can readily evoke an increased propensity to 'mirror' other peoples' actions.~     Particularly, using transcranial magnetic stimulation (TMS), the investigators showed that~     mirror-motor mapping at the level of the primary motor cortex (M1), also known as~     interpersonal motor resonance (IMR), is significantly increased upon the observation of~     actions accompanied by direct eye contact, compared to the observation of actions accompanied~     by averted eye gaze.~      With the present study, the investigators aim to investigate the role of eye contact on IMR~     further, and in particular, explore whether administration of the 'prosocial' neuropeptide~     oxytocin (OT) can influence eye-contact induced IMR. In general, OT is known to play an~     important role in promoting prosocial behavior and the perception of socially-relevant~     stimuli, such as eye gaze. To date however, the link between OT and IMR is less clear.~   "
42477|NCT03010761|"~     No medication existed for BQ dependence. No clinical trials existed for the drug therapy.~     Previous study showed that BQ possessed the antidepressant effect via pathway of monoamine~     oxidase A (MAO-A). An animal model also found that the arecoline from BQ has a property as~     MAO-A inhibitor. Therefore, the investigators hypothesized that inhibition of the MAO-A or~     antidepressants might reduce the BQ addiction severity.~      The investigators will conduct the randomization and double blinded with placebo controlled~     study with 90 participants with BQ dependence from the Family Medicine and ear, nose, and~     throat (ENT) outpatient department (OPD). All participants shall agree the informed consent.~     The range of age is from 18 to 65 years old. The participants are diagnosed as BQ use~     disorder without other psychiatry co-morbidity, according to the Diagnostic and Statistical~     Manual (DSM)-V criteria. Those who have severe physical illness, psychiatric illness, and~     other substance use disorder except cigarettes are excluded. All participants receive the~     semi-structure interview by DSM-V, International Classification of Diseases (ICD)-10, and~     Mini International Neuropsychiatric Interview by the psychiatrist. Before the intervention,~     the participants will finish their basic data, daily amount of cigarettes, betel nut, medical~     history and psycho-social rating scales. Next, in addition to counseling, the investigators~     will continue or modify the optimal antidepressants based on the previous results.~      The investigators will evaluate their BQ use condition as what has been measured in the~     natural observation study of the first year. The investigators will check the outcome~     measurement by visual analog scale, betel quid withdrawal severity scale, Yale-Brown~     Obsessive-Compulsive (Y-BOCS) - betel quid (BQ) scale. The investigators also followed their~     hamilton depression scale; Beck depression index; and Beck anxiety index in the baseline,~     2nd, 4th, 6th , and 8th week. The investigators also obtained the participants' gene type if~     the participants also agree for the prediction of oral cancers.~   "
42478|NCT03010748|"~     Based on the corneal morphometry instrumentation Oculus Pentacam, which is commonly used~     before and after clinical refractive surgery, we will collect the corneal morphological and~     biologic parameters of the population under refractive surgery screening in refractive~     surgery centers around the country, and construct corneal morphology database in different~     living areas of Chinese people. Based on this, compared with the suspected keratoconus and~     keratoconus population, the screening criteria and reference standards accord with the~     characteristics of keratoconus of Chinese ethnic will be achieved.~   "
42479|NCT03010735|"~     The purpose of this study is to investigate the effects of oral administration of~     Bifidobacterium animalis A6 on the metabolism of uremic toxins, in the patients with End~     Stage Renal Disease (ESRD). One hundred and fifty hemodialysis patients are recruited, and a~     Double Blind Randomized Parallel Controlled Trial was performed.The microbiota-derived uremic~     toxin, such as indoxyl sulfate and p-cresol sulfate, are measured as Primary Outcome. The~     Fecal microbiome, fecal metabolites, blood metabolites, defecation, Gastrointestinal Symptoms~     The Kidney Disease Quality of Life and The Occurrence of Cardiovascular Event are also~     assessed.~   "
42480|NCT03010722|"~     This is a single centre prospective biological translational research study involving the~     collection of tumour tissue, blood samples and clinical data from patients being treated with~     regorafenib for metastatic Colorectal Cancer (mCRC) at the Royal Marsden Hospital. Patients~     will be eligible for the study if they have a histological diagnosis of CRC, are refractory~     to standard available therapies with palliative intent for mCRC, have received prior~     treatment with at least one anti-VEGF antibody and chemotherapy drugs including fluorouracil~     (5FU) or capecitabine, oxaliplatin and irinotecan, and patients have RAS mutant tumours.~   "
42481|NCT03010709|"~     Aneurysmal subarachnoid haemorrhage (aSAH) affects up to 10,000 individuals per year in the~     UK. It accounts for ~5% of strokes, but is responsible for about 25% quality-adjusted life~     years (QALYs) lost due to stroke. Although early repair of ruptured aneurysms and aggressive~     postoperative management has improved overall outcomes, it remains a devastating disease with~     mortality approaching 50%. Survivors are left with neurological injuries that range from~     subtle cognitive deficit to disabling cerebral infarctions, less than 60% them returning to~     functional independence.~      SAH triggers a series of pathological processes resulting in neuronal damage and consequent~     neurological deficit termed early brain injury (EBI). Many of the patients who survive the~     initial bleed, deteriorate days later from delayed ischaemic neurological deficit (DIND),~     which causes poor outcome or death in up to 30% of patients with SAH. Both of these~     pathological processes are still poorly understood which limits the number of treatment~     options.~      DIND is treated with blood pressure augmentation to ensure adequate blood flow in the brain.~     In awake patients, response can be easily and accurately assessed by performing a thorough~     neurological examination. In patients whose clinical condition demands sedation, intubation~     and ventilation, assessing response to treatment using the neurological examination is~     virtually impossible. Multimodality monitoring (MM), primarily microdialysis and brain tissue~     oxygen tension with catheters inserted into the relevant parts of the brain offer direct~     assessment of both delivery and utilisation of metabolic substrates at the cellular level.~     These can be used for early detection of DIND as well as monitoring during blood pressure~     augmentation. The aim of this study is to establish and validate a clinical protocol for MM~     derived management of SAH patients, to determine optimal therapies for correcting~     abnormalities in brain metabolism and explore the relationship between MD and other~     monitoring modalities.~   "
42482|NCT03010696|"~     The purpose of this study is to investigate the differences of gut Microbiome/Metabolite~     between ESRD patients and healthy subjects. Two hundred and twenty three hemodialysis~     patients and 70 healthy subjects are recruited, and a cross-sectional study is performed.~   "
42483|NCT03010683|"~     Arterial stiffness is associated with increased risk for cardiovascular disease. Moreover,~     the integrity of endothelial glycocalyx plays a vital role in vascular permeability,~     inflammation and elasticity. Agonists of Glucagon like peptide - 1 receptors (GLP-1R) used in~     the treatment of type 2 diabetes mellitus (T2DM). This category includes exenatide and~     liraglutide. These drugs lower glucose levels by inhibiting the secretion of glucagon,~     promoting the release of insulin in response to hyperglycemia, slowing gastric emptying, and~     augmenting satiety. Clinical studies have shown that GLP-1R agonists have beneficial effects~     on cardiovascular function in both diabetic patients and healthy subjects. The purpose of~     this study is to investigate in patients with T2DM without coronary artery disease (CAD),~     patients with T2DM and CAD and obese patients with abnormal oral glucose tolerance test~     (OGTT), changes in arterial stiffness, endothelial glycocalyx thickness and coronary reserve~     flow (CFR) after treatment with metformin or agonist GLP-1R.~   "
42485|NCT03010657|"~     This study evaluates an eating strategy in adults undergoing chemotherapy for non-small cell~     lung cancer. Subjects will be allocated to a randomized or observational arm based on~     baseline measurements. In the randomized arm, half of participants will add certain foods to~     what they normally eat, while the other half will continue to eat their habitual diet.~     Subjects in the observational arm will continue to eat their habitual diet.~   "
42534|NCT03010007|"~     Influenza associated illness has a global annual impact with high morbidity and mortality.~     Transmission mechanisms and rates are under-investigated and overall poorly understood.~      This project aims to use epidemiological tools to understand the transmission and evolution~     of influenza viruses at an individual and population level within a small-scale city (Basel)~     through a combination of experimental, clinical and mathematical advances. The investigators~     aim to quantitatively characterize the viral transmission using novel~     molecular-epidemiological tools based on whole genome sequencing.~   "
42486|NCT03010644|"~     The consequences of childhood obesity are devastating, affecting the physical and mental~     health of children. Disadvantaged school-age children are at risk for unhealthy gains in BMI~     during the summer months and there is a dearth of information regarding the causal health~     behaviors and environmental factors. The overall objective of this application is to provide~     an in depth examination of key dietary and physical activity behaviors as well as the food,~     physical activity, and social environments of low-income, racial/ethnic school-age children.~     To achieve this goal, an observational study utilizing a multi-state prospective cohort~     design will be conducted with the goal of examining the weight gain trajectory among a~     racially and ethnically diverse convenience sample of disadvantaged school-age children who~     routinely attend structured programming during the summer months and those who don't~     participate in structured programming. In addition, a subset of these children will be~     evaluated to learn their daily health behaviors, as well as their food, physical activity,~     and social environments during the summer. Identification of determinants of program~     participation and factors that may enhance the beneficial effects of program participation~     will also occur. A social ecological framework approach will guide the research. This study~     can be expected to have a significant positive impact by providing information on the factors~     that protect disadvantaged children from unhealthy weight gain during the summer which can be~     used by stakeholders at the local, state, and federal level to reform current policy that~     will increase child participation in health promoting programming during the summer window of~     risk.~   "
42487|NCT03010631|"~     A study to compare the pharmacokinetics and food-effect bioavailability of lubiprostone~     sprinkle in healthy volunteers.~   "
42488|NCT03010618|"~     In recent years restoring carious of fractured primary teeth with stainless steel crowns~     (SSC) has became more popular than ever. On the other hand the traditional operative approach~     of complete removal of caries is steadily losing support due to successful results with~     materials of high microleakage resistance.~      Treatment time and pain control in asymptomatic teeth has always been a problem in children.~     Hall technique is a minimally invasive treatment protocol that doesn't require local~     anesthesia, use of rotating devices for caries removal to restore primary teeth with SSC.~      But this protocol also raised questions in the scientific community about its possible~     effects on the dentition and temporomandibular joint (TMJ) for causing primary occlusal~     contact and increasing vertical dimension.~      The aim of our research is to study the effects of Hall technique's premature occlusal~     contact on TMJ.~   "
42489|NCT03010605|"~     Achieving adequate range of motion post Total Knee Arthroplasty(TKA) is an important goal for~     return to optimum function. Traditionally, adequate range of motion has been achieved by a~     combination of in-home and outpatient physical therapy. While physical therapy is successful,~     it has the limitation of cost and availability. As copayments rise, patients may decide that~     they cannot afford physical therapy, potentially compromising the outcome of their surgery~     and successful return to function.~      It is assumed that having an easy and fun to use, patient administered, incentive device that~     provides accurate, quantitative flexion and extension measurements may accelerate patient~     mobility and return to function after TKA. The Measuring Every Day (MED) portable goniometer~     is commercially available and provides objective, consistent range of motion measurements~     that are recorded and can be sent electronically to the clinician's office potentially~     enabling earlier clinical or therapy adjustments or modifications to the prescribed therapy.~      Goniometry is a commonly used tool to measure and document range of motion (ROM) during~     clinical evaluation or a physical therapy examination. The technique is used to assess the~     limitations of a patient's joint and provide information to the clinician that may help~     determine further treatment.~      The study is designed to compare range of motion measurement data for 6 weeks in patients~     that have been randomized to receive either traditional physical therapy or the MED device.~     The hypothesis is that patients who use the MED device achieve equivalent range of motion at~     six weeks as compared to patients participating in traditional standard of care physical~     therapy.~   "
42490|NCT03010592|"~     Studying the airway microenvironment in patients undergoing surgical and bronchoscopic~     interventions for COPD~   "
42491|NCT03010579|"~     This is an randomized trial to evaluate the potential benefit of erythropoietin in the~     treatment of anemia in patients with lymphoma after autologous hematopoietic stem cell~     transplantation.~   "
42492|NCT03010566|"~     Studying the microbiome of the lung in patients treated with endobronchial lung volume~     reduction coils for emphysema~   "
42493|NCT03010553|"~     Fifty patients with squamous cell carcinoma of the larynx T1 or T2N0 will therefore have a~     99mTc lymphoscintigraphy per operative. The identified sentinel node will be removed along~     with the other lymph nodes of the selective group II and III recess. Sentinel lymph node~     staging alone and complete dissection with routine anatomical pathology will be compared If~     this technique is reliable it will make a therapeutic de-escalation in the treatment of small~     tumors of the larynx by limiting the ganglionic gesture in the patients whose sentinel node~     is free from metastasis and also to better choose the treatment in case of lymph node~     involvement~   "
42494|NCT03010540|"~     Emergence Delirium And Recovery Profile In Patients Undergoing Cleft Lip And Cleft Palate~     Repair With Either Combination Of Morphine Plus Fentanyl Or Fentanyl Alone~   "
42495|NCT03010527|"~     This is a multicenter extension study to assess the long-term safety, tolerability and~     efficacy of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis~   "
42496|NCT03010514|"~     This is a national registry study to determine genetic risk factor and serial biomarkers of~     thoracic aortic aneurysm/dissection~   "
42497|NCT03010501|"~     In this study, the investigators will vary the energy density of foods served during three~     5-day periods. There will be a baseline condition, and then a condition where the energy~     density of food is lower and a condition where the energy density of food is higher. The~     primary aim is to determine the effect of varying the energy density of foods served over 5~     days on energy intake in preschool children. It is hypothesized that mean daily energy intake~     will be greater when children are served higher energy dense foods over 5 days than when~     served lower energy dense foods over the same period. Additionally, it is hypothesized that~     daily energy intake in the conditions with higher and lower energy densities will begin to~     converge across the 5-day period.~   "
42498|NCT03010488|"~     Previous data suggest some depressed patients act as if their internal biological clock is~     out of sync with the outside world and re-aligning their clock with the timing of sunlight~     lessens their depressed mood and accompanying depressive symptoms. This chronotherapy may~     produce remission during the first week of treatment while causing minimal problems. This~     study aims to demonstrate the efficacy of chronotherapy by comparing two protocols for~     inducing sleep phase advance. Which chronotherapy condition a participant will receive will~     be determined randomly (i.e., by chance, essentially a computerized flip of a coin). Prior to~     determination of which protocol a patient will follow, each patient will declare their~     desired sleep time (for example, 11 p.m. to 7 a.m.). All patients will be assigned specific~     times to sleep and sit in front of bight lights wearing clear or amber goggles. Assigned~     sleep times will differ between groups using different strategies to shift the timing of~     their sleep from their ideal sleep time as determined by their Morningness-Eveningness~     Questionnaire (MEQ) score to their desired sleep time. All participants will be rated daily~     by telephone for the first week following randomization, and then weekly for an additional~     five weeks. Whenever possible, weekly visits will be in person, although telephone visits~     will be allowed. All participants will be rated at baseline, 1 week and 6 weeks by an~     Independent Evaluator blind to treatment assignment (as well as the nature of the treatment~     and if it has occurred or not). After the six week post-randomization evaluation, all~     participants will be offered six months of continued treatment and be rated monthly.~     Treatment during this six month period may consist of Chronotherapy or conventional~     antidepressants as the patient and doctor determine. Standard ratings of depression, over-all~     illness and functioning will be obtained. Change in the symptom measures will determine~     treatment efficacy. Analysis of saliva melatonin levels, sleep logs and activity monitor data~     will measure the timing of the biological clock and whether it has been shifted by the~     treatment. Measures of functioning will determine whether functioning improves coincident~     with, independent of, or subsequent to mood improvement.~   "
42499|NCT03010475|"~     This trial is conducted in Europe. Tha aim of this trial is to investigate the effect of oral~     semaglutide on the pharmacokinetics of furosemide and rosuvastatin in healthy subjects.~   "
42500|NCT03010462|"~     A prospective, multi-center, randomized, sham-controlled, blinded study combining active~     Nexstim NBS-guided 1Hz rTMS or sham-rTMS targeting the healthy hemisphere with standardized~     task oriented rehabilitation will be conducted in patients with post-stroke motor impairment~     of the upper limb. The therapy will be provided for 6 weeks and primary outcome assessed 6~     months later.~   "
42501|NCT03010449|"~     A single arm pilot study of lung volume reduction in severe emphysema using bronchoscopic~     autologous blood instillation in combination with intra-bronchial valves.~   "
42502|NCT03010436|"~     Benralizumab is a type of medicine called a monoclonal antibody that is made in the research~     clinic; it works by blocking a specific protein in the body called interleukin-5. The study~     medicine, benralizumab, is not yet approved for doctors to treat patients with EGPA. It is~     considered an experimental drug in this study.~   "
42503|NCT03010423|"~     The study is a single-center, interventional, pilot study to evaluate the improvement of~     microvascular function by positron emission tomography (PET) after twelve-week treatment of~     oral nicorandil in female non-obstructive CAD subjects.~   "
42504|NCT03010410|"~     Aging is associated with immunosenescence and impaired host defense mechanisms, contributing~     to influenza-related morbidity and mortality. Preliminary data demonstrate that the platelet~     transcriptome is markedly different between healthy subjects and influenza patients.~     Interferon-induced transmembrane proteins (IFITM) family members are among the transcripts~     significantly increased in platelets during influenza and expression of IFITM-3 is impaired~     in elderly subjects, a pattern associated with increased mortality. This study will build on~     these data and investigate if aging influences the expression of platelet IFITM family~     members in patients with influenza and sepsis.~      This study will prospectively determine if aging alters the induction of (IFITMs) in~     platelets from hospitalized influenza and sepsis patients. The study will also determine if~     diminished expression of IFITM family members correlates with an increased risk of adverse~     outcomes in older influenza and sepsis patients.~   "
42505|NCT03010397|"~     Progression of Diabetic Retinopathy. Identification of Signs and Surrogate outcomes~     (PROGRESS)~   "
42506|NCT03010384|"~     The aim of this study was to investigate the impact of a rehabilitation program including a~     physician specialized in social medicine parallel to treatment for suspected spinal disc~     herniation.~   "
42507|NCT03010371|"~     This multicenter study aims to prove the efficacy of a pilot psychosocial evidence-based~     treatment (Positive Psychotherapy) in two formats (online vs face-to-face) with an online~     support control group. It develops as a randomized-controlled trial in a group of primary~     breast cancer survivors assigned to one of the three experimental treatments. The principal~     dependent variables assessed will be emotional distress, post-traumatic growth and QoL. Some~     treatment predictors of psychosocial response will be explored. Lastly, an economic analysis,~     comparing the three psychosocial treatments and focused on the quality adjusted life years~     (QALY) will be made. It is expected to find higher efficacy in psychosocial indicators and~     QALY for Positive Psychotherapy in the two experimental intervention formats than in the~     online support group. It is hypothesized that the face-to-face format will be more effective~     for severely distressed patients with previous history of trauma, while the online format~     will be more effective for younger patients with mild emotional distress.~   "
42508|NCT03010358|"~     This phase I/II trial studies the side effect and best dose of entospletinib when giving~     together with obinutuzumab and to see how well they work in treating patients with chronic~     lymphocytic leukemia, small lymphocytic lymphoma, or non-Hodgkin lymphoma that has come back.~     Entospletinib may stop the growth of cancer cells by blocking some of the enzymes need for~     cell growth. Monoclonal antibodies, such as obinutuzumab, may interfere with the ability of~     cancer cells to grow and spread. Giving entospletinib and obinutuzumab together may work~     better in treating patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, or~     non-Hodgkin lymphoma.~   "
42509|NCT03010345|"~     patient receiving treatment using the osmed expander will have enough soft tissue coverage~     securing the bone graft which will be placed in a later stage to close the alveolar cleft.~   "
42510|NCT03010332|"~     This is an expanded access protocol designed to provide access of ATA230 to subjects with~     cytomegalovirus (CMV) viremia or disease, who are intolerant to, or failed, standard~     antiviral therapy and have no comparable treatment options.~   "
42511|NCT03010319|"~     The study will evaluate the efficacy of PriMatrix Dermal Repair Scaffold in the management of~     diabetic foot ulcers in subjects with diabetes mellitus versus the Standard of Care~     treatment. Half of patients will be treated using PriMatrix while the other half will receive~     Standard of Care treatment.~   "
42548|NCT03009825|"~     The purpose of this study is to investigate the associations between lifetime exposure to~     traumatic events, emotion regulation strategies, and eating pathology of patients with~     obesity.~   "
42513|NCT03010293|"~     Pressure ulcer represents a frequent clinical condition in patient with spinal cord injury or~     after prolonged Intensive Care Unit (ICU) stay. Osteomyelitis constitutes a severe~     complication with a poorly known management, and is associated with a high rate of relapse,~     leading to a high-burden in hospital bed-days, financial cost, surgical intervention,~     antibiotic use, morbidity and mortality, and nursing care. In our reference center for bone~     and joint infection management, the medical and surgical strategies are systematically~     discussed during pluridisciplinary meetings. Most patients benefit from a two-stage surgical~     strategy (debridement with initiation of vacuum-assisted closure therapy until reconstruction~     using muscular flap) with prolonged antimicrobial therapy. In this context, our study aims to~     evaluate this complex approach and to determine risk factors of treatment failure in order to~     improve patient management, focusing on optimization of empirical antimicrobial therapy after~     each surgical stage, delay between the two surgical stage, and duration of antimicrobial~     therapy.~   "
42514|NCT03010280|"~     A prospective randomized clinical trial of all the patients undergoing Roux - en-Y gastric~     bypass will be performed. Patients will be randomly assigned into 2 groups: those patients~     receiving a preoperative balanced energy high-protein formula (group 1) and those receiving~     preoperative Immunonutrition (group 2). Changes between groups in acute inflamatory markers,~     pain, postoperative septic complications and lenght of stay, among others will be~     investigated.~   "
42515|NCT03010267|"~     A randomized, open-label, crossover, Phase I clinical trial to compare the pharmacokinetics~     of DP-R213 (Raloxifenel and Cholecaliferol fixed dose combinations) in comparison to each~     component administered alone in healthy male volunteers.~   "
42516|NCT03010241|"~     Background: Distal symmetric polyneuropathy (DSPN) is the most common complication of type 2~     diabetes mellitus (T2DM) and the most common form of peripheral neuropathy. DSPN increases~     the risk of foot ulceration up to seven-fold, and is a significant risk factor in more than~     60% of the amputations of the lower limbs in patients with T2DM. Reportedly, TCM may have~     some advantages in relieving symptoms and reducing the incidence of DSPN exacerbations.We~     postulate that patients with DSPN will benefit from therapy with TCM treatment according to~     syndrome differentiation.~      Methods and design: A randomized, double-blind, placebo-controlled and multi-centric clinical~     trial design was used on the basis of a co-regimen of mecobalamin. Subjects who met the~     inclusion criteria were randomly divided into two groups. The patients in the study group~     were treated with Tangbi prescription, and the patients in the control group were treated~     with placebo. Treatment was scheduled for 24 weeks. The sample size was 188 cases.Major~     evaluation indicators: Changes in Clinical Symptoms and Signs in Distal Symmetrical~     Polyneuropathy patients.The clinical symptoms and signs of patients were recorded by Michigan~     Diabetic Neuropathy Score(MDNS), and the changes of Michigan Diabetic Neuropathy Score(MDNS)~     were compared between the two groups before and after medication. Secondary Evaluation~     Indicators:① nerve conduction velocity changes, The changes in nerve conduction velocity of~     each nerve were compared before and after taking medicine.② Clinical symptoms and signs~     change, The clinical symptoms and signs of the patients were compared before and after taking~     the medicine.~      Discussion: We postulate that patients with DSPN will benefit from therapy with TCM~     treatment.~   "
42517|NCT03010228|"~     Observer-blind, partially randomized, multi-center dose escalation Phase I study in healthy~     adults below 40 years of age.~      180 subjects will be enrolled in 6 treatment groups (different doses; different formulation:~     with/without adjuvant); vaccinations will be given I.M.(intramuscular) into the deltoid~     region on Days 0, 28 and 56. Study participants will be followed up until one year after~     first vaccination.~      Booster Extension:~      Subjects in the 48µg and 90µg Treatment groups who received a complete Primary immunization~     schedule will be included into a Booster Extension 13 months after the first immunization.~   "
42518|NCT03010215|"~     Despite the development of the control of DM and the great interest for the complications of~     the disease, even today the diabetic foot represents a challenge for the orthopaedic surgeon.~     Being frequently correlated to alteration of the plantar pressures, the surgery treatment is~     recommended and the Minimally Invasive Surgery (MIS) candidates itself to solve this~     pathologic case.~      The purpose of this longitudinal cross-sectional study was to evaluate radiographic and~     surgical outcomes and the subjective grade of satisfaction of the patients with a diagnosis~     of chronic plantar diabetic foot ulcers that have been treated at Padua's Orthopaedic Clinic~     through MIS.~   "
42519|NCT03010202|"~     This study is a two phase study that aims to evaluate if low-dose Rituximab maintenance~     therapy may prolong the the effect of Rituximab in immune thrombocytopenia.~   "
42520|NCT03010189|"~     Cluster headache is one of the most painful headaches, characterized by recurring episodes of~     unilateral, periorbital pain, which is accompanied by autonomic symptoms that seem to be of~     both sympathetic and parasympathetic origin. The pathophysiology behind the condition is~     largely unknown, but increasing evidence indicate that the hypothalamus plays a pivotal role.~     The headache attacks come in clusters or bouts (hence the name) which last up to three~     months, after which the headache disappears for at least one month. 10-15% have chronic~     cluster headache. During attacks, the patients have cranial sympathetic hypoactivity and~     parasympathetic hyperactivity, whereas they have cranial parasympathetic hypoactivity during~     remission phase. There is an emerging hypothesis that headache attacks are elicited in a~     state of autonomic hypoarousability, which is also supported by the fact that most cluster~     attacks occur during the night, when the patients are sleeping.~      The aim in this project is to study the intercept between the sleep-wake cycle, autonomic~     tone and the occurrence of headache attacks, by using actigraphy, heart-rate variability and~     pupillometry. All these methods are well validated, and frequently used in studies on sleep~     and autonomic function. The study design is that of a case-control model where 15 cluster~     headache patients will undergo pupillometry, before wearing the actigraph and heart-rate~     variability-monitor for two weeks, once in cluster bout and once in remission phase. The~     actigraphy will register nocturnal movement and sleep quality, and headache attacks will be~     registered by pressing a button on the actigraph. The pupillometry measures pupillary~     constriction and dilation in response to light, a reflex that is controlled by the autonomic~     nervous system. The heart-rate variability monitors fluctuations in the heart rate which~     reflects the sympathovagal balance of cardiac control. All participants will fill out the~     Pittsburgh Sleep Quality Index before and after registration. In addition, 15 healthy~     controls will undergo one session of the same examinations. The results of the study will~     give valuable insight to the pathophysiology of a condition that is very painful and has~     great impact on the patients' quality of life, and also add knowledge to the relation between~     headache, sleep and the autonomic nervous system.~   "
42549|NCT03009812|"~     The Aim of the study is to compare between transverse and longitudinal uterine incision in~     abdominal myomectomy regarding intraoperative blood loss.~   "
42550|NCT03009799|"~     This clinical investigation aims at demonstrating that NCX-4240 is effective and safe in~     decreasing the number of days where adenoviral conjunctivis is detected in the eye and in~     reducing the duration and/or the severity of the signs and symptoms of adenoviral~     conjunctivis~   "
42521|NCT03010176|"~     The purpose of this study is to identify a maximum tolerated dose (MTD) or maximum~     administered dose (MAD) of MK-1454 alone and of MK-1454 in combination with pembrolizumab~     (MK-3475) in participants with advanced/metastatic solid tumors or lymphomas. MK-1454 will be~     administered intratumorally (IT); pembrolizumab (pembro) will be administered intravenously~     (IV). Participants will be allocated to one of three treatment arms: MK-1454 monotherapy~     (cutaneous/subcutaneous [cut/subcut] lesions), MK-1454+pembrolizumab (pembro)~     (cutaneous/subcutaneous lesions), or MK-1454+pembro (liver metastasis/lesions). The~     MK-1454+pembro (liver metastasis/lesions) arm will initiate subsequent to establishment of~     the MTD/MAD dose level of the MK-1454+pembro (cutaneous/subcutaneous lesions) arm.~   "
42522|NCT03010163|"~     This study is divided into four groups. Group 1 includes Health Fairs implemented at NYC taxi~     garage bases and airport taxi holding lots and pedometers. Group 2 includes Health Fairs,~     pedometers and text messaging to facilitate walking and living a healthier lifestyle. Group 3~     includes Health Fairs, pedometers and social network support. Group 4 includes Health Fairs,~     pedometers, text messaging and social network support.~   "
42523|NCT03010150|"~     The goal of this clinical research study is to learn about the reasons head and neck cancer~     patients may or may not follow the swallowing exercises that they are asked to perform after~     receiving radiation treatments. Researchers also want to learn if certain levels of cytokines~     affect if participant has side effects and if it puts participant at risk for future disease.~     Cytokines are proteins that are related to the immune system.~   "
42524|NCT03010137|"~     Incisional negative pressure therapy (INPWT) has previously been shown in certain patient~     populations to decrease wound healing complications, decrease the rate of hematomas and~     seromas, as well as have better scar quality. We have found a group of patients, those who~     have panniculectomies in preparation for renal transplant, with significantly higher rates of~     wound healing complications. We believe the best way to demonstrate benefits of incisional~     negative pressure wound therapy will be in this group of patients known to have significantly~     higher rates of wound complications.~   "
42525|NCT03010124|"~     The investigators therefore propose to conduct a biological study of prospectively collected~     patient tumour samples, ascites, blood and other residual samples (feces, urine, cervical~     smear) throughout the disease course where markers (at diagnosis and their change with~     treatment) will be correlated to outcome in order to investigate how genetic diversity in OC~     prior to treatment and adaptation following treatment contribute to chemotherapy resistance.~     In addition freshly collected ascitic samples (and tumour samples) will be subjected to ex~     vivo DNA repair functional assays and isolated in primary culture (and established as~     xenografts) for target validation experiments.~   "
42526|NCT03010111|"~     The investigators aim to study the prevalence of latent tuberculosis infection (LTBI) using~     whole-blood interferon-r release assays, and determine the risk factors of LTBI in Korean~     health care workers.~   "
42527|NCT03010098|"~     To investigate the effect on older's cognition of the application of closed target-controlled~     infusion(TCI) of propofol and remifentanil guided by Narcotrend index .~   "
42528|NCT03010085|"~     Open versus Laparoscopic Left-sided Hepatectomy (OLLEH) trial Multi-institutional,~     prospective and randomized trial in patients undergoing left sided hepatectomy through~     laparoscopic versus open procedure.~      Primary endpoint: Functional recovery Secondary endpoint: Hospital duration, estimated blood~     loss, operation time, resection margin status, postoperative complication, mortality, liver~     function laboratory test, re-admission, quality of life, cosmesis, cost effectiveness~   "
42529|NCT03010072|"~     This is a single-center, prospective, open-label, controlled, randomized, cross-over study in~     34 prevalent end-stage renal disease patients on chronic hemodialysis treatment with~     hyperphosphatemia.~   "
42530|NCT03010059|"~     The purpose of this study is to assess the rate and extent of absorption of JNJ-64041575 by~     measuring ALS-008112 plasma concentrations following administration of a single oral dose of~     JNJ-64041575 given as 2 new concept formulations (oral suspension and tablet) compared to~     their respective current formulations under fasted conditions and to assess the effect of~     food on the pharmacokinetics of the 2 new concept formulations under fed condition in healthy~     adult participants.~   "
42531|NCT03010046|"~     This is a single-center, randomized, double-blind, placebo-controlled, ascending,~     single-infusion, sequential group study. Single, ascending doses will be administered to~     approximately 64 subjects, with an option for 1 additional multi-dose cohort in approximately~     8 subjects. The primary objective is to evaluate the safety of ANX005 administered as an~     intravenous infusion as a single agent and in combination with intravenous immunoglobulin~     (IVIg). The optional multi-dose cohort will evaluate either additional subjects at the~     maximum tolerated dose or ANX005 administered as 2 infusions.~   "
42532|NCT03010033|"~     It is reported that smoker patients (>400 cigarette/year) will suffer more postoperative~     complications than non-smoker patients after lobectomy. Evidences has suggested pulmonary~     rehabilitation could reduce the pulmonary complications after thoracic surgery. However, the~     effect and long-term results of pulmonary rehabilitation on smoker patients have not been~     studied. The purpose of this study is to determine whether pulmonary rehabilitation is~     effective to smoker patients who underwent lobectomy.~   "
42533|NCT03010020|"~     The investigators propose to develop and pilot an HIV prevention intervention based on rectal~     STI testing, counseling, and treatment for MSM in Peru. The investigators will use nucleic~     acid testing to screen 750 behaviorally high-risk MSM for rectal gonorrheal and/or chlamydial~     (GC/CT) infection. GC/CT-positive subjects will receive single-dose antibiotic treatment and~     single-session Personal Cognitive Counseling (PCC) (n=50) or standard post-test counseling~     (n=50). A GC/CT-negative control group (n=50) will also be enrolled to compare biological~     outcomes including changes in levels of inflammatory cytokines following rectal STI. The~     intervention is based on three interrelated objectives: 1) To use periodic rectal STI nucleic~     acid testing to identify the members of the MSM population at greatest short-term risk for~     HIV infection; 2) To provide single-dose antibiotic treatment to control the immune~     activation and mucosal inflammation caused by rectal GC/CT infection that increase cellular~     risk for HIV transmission; and 3) To use Personal Cognitive Counseling (PCC) to understand~     and modify recent high-risk sexual practices that led to rectal STI acquisition and that~     increase future HIV risk.~      The investigators propose to screen 750 behaviorally high-risk MSM for rectal GC/CT infection~     to enroll 100 GC/CT-positive individuals (using a conservative 15% prevalence estimate) and~     50 GC/CT-negative controls (matched by age and baseline frequency of URAI). GC/CT-infected~     participants will be given single-dose antibiotic therapy and randomized to receive~     single-session PCC (n=50) or standard post-test counseling (n=50). The primary outcome will~     be the impact of PCC on self-reported sexual risk behavior (URAI). Secondary outcomes will~     assess: 1) Feasibility/Acceptability of the STI screening program; 2) Impact of GC/CT~     infection and treatment on levels of inflammatory cytokines (IL-6, IL-8, TNF-αand IL-1β) in~     rectal mucosa; 3) Prevalence of persistent/recurrent rectal GC/CT; and 4) HIV incidence in~     GC/CT-infected and -uninfected MSM.~   "
42535|NCT03009994|"~     Cesarean section is one of the most frequently performed major operations worldwide. It~     accounts for between 1% and 70% of deliveries depending on the facilities or country~     assessed. In Egypt, the cesarean section rate is 22%, with higher rates seen in private~     hospitals. In 2015 ,incidence of cesarean section rate in Woman Health Hospital in Assiut~     university is 51.3% of all deliveries.~      Different Operational techniques For cesarean section have been defined aimed at reducing~     surgical time, making the surgery easier and more efficient, lowering costs,decreasing the~     risk of adverse effects and postoperative morbidity, as well as length of hospital stay.~      Also, Intraoperative blood loss is one of important complications during cesarean section. A~     systematic review included twenty one studies, in 2011, revealed that increase incidence of~     intraoperative blood loss and blood transfusion with increase number of cesarean~     deliveries.also anemia in the pregnancy increase maternal morbidities included intraoperative~     blood loss. In Egypt, prevalence of Iron deficiency anemia among pregnant women about 51% of~     pregnant women.~      After baby born by cesarean section and the placenta has been extracted, uterine incision is~     sutured either by temporary removal of the uterus from the abdominal cavity (exteriorization~     of the uterus) to facilitate uterine incision repair or it is repaired within the abdominal~     cavity (in situ repair). There had been few randomized controlled trials comparing~     intraoperative and postoperative morbidity following exteriorization of the uterus with~     non-exteriorization. The conclusions drawn from these trials have been conflicting.~   "
42536|NCT03009981|"~     This is a randomized, open-label, three-arm, phase 3 study in men with biochemically~     recurrent prostate cancer and PSA doubling time ≤ 9 months at the time of study entry.~   "
42537|NCT03009968|"~     After reconstructive pelvic surgery urinary retention occurs in up to 60% of patients~     requiring an indwelling catheter or self-catheterization (1-5). Up to 35% of women with acute~     retention experience urinary tract infections in the postoperative period (6, 7). Many women~     consider being discharged with a Foley catheter to be a surgical complication and describe~     catheter use as the worst aspect of their surgery(8). At this time there is no consensus~     within the field of Female Pelvic Medicine and Reconstructive Surgery (FPMRS) on how to best~     assess voiding function postoperatively. FPMRS providers both within the United States and~     around the world utilize a variety of void trial methods and varying criteria to determine~     adequacy of post-operative voiding efficiency (5).~      The traditional backfill assisted void trial method involves the assessment of a postvoid~     residual (PVR) volume obtained either via catheterization or bladder scan (3). Recently,~     there have been efforts to determine ways to avoid the assessment of a PVR as it is~     time-consuming and potentially exposes the patient to additional catheterizations (9, 10).~     Many FPMRS providers utilize the backfill assisted method without assessing a PVR and instead~     utilize a certain voided volume threshold to determine adequate voiding. However, to date, no~     one has directly studied this approach or compared the traditional backfill assisted void~     trial to a PVR-free backfill assisted void trial. By decreasing catheterization and creating~     a more efficient void trial method, the investigators hope improve patients' postoperative~     experience and reduce catheterization and risk of urinary tract infection (UTI).~      This study aims to compare two void trial methodologies in order to help standardize~     post-operative care in the urogynecology population. This study also has potential to lead to~     an overall change in our field and improve the postoperative course for women across the~     country and abroad.~   "
42538|NCT03009955|"~     To everyone knows, more and more patients received repeated caesarean section in China.~     However, at present it is not known what is it like about their postoperative pain intensity,~     and is it different from those patients who received primary caesarean section. Thus through~     postoperative follow-up, the current study aimed to investigate and compare the postoperative~     pain between patients received primary and repeated caesarean section.~   "
42539|NCT03009942|"~     This study evaluates the nitric oxide and arginase levels in patients with dental implants.~     Peri-implant sulcular fluid and saliva samples were collected after loading of the implants~   "
42540|NCT03009929|"~     Whereas there are several validated systems for reporting postoperative complications, there~     are only a few and not prospectively validated systems for reporting intraoperative~     complications. The investigators developed a definition and CLASSification for Intraoperative~     Complications CLASSIC within a Delphi study involving international interdisciplinary~     experts. As both surgery and anaesthesia may be involved in complications in the~     perioperative period, all patient-related intraoperative complications occurring between skin~     incision and closure are considered in this reporting system.~      The aim of this international multicentre observational cohort study is to assess the~     validity and practicability of this newly derived classification system CLASSIC in patient~     undergoing an in-hospital surgical procedure. Providing an easy applicable and~     internationally validated classification system is a contribution to improve quality of~     health care and patient safety.~   "
42541|NCT03009916|"~     The aim of this study is to examine the influence of BAM on postprandial GLP--1 secretion and~     glucose homeostasis, both with and without bile acid sequestration.~   "
42542|NCT03009903|"~     This multi-center, outpatient study will extract and evaluate the presence of facial P. acnes~     bacteria and phage strains using pore strips on up to 400 human subjects.~   "
42543|NCT03009890|"~     Objective: to compare the functional outcome after open reduction and internal fixation with~     non-operative cast treatment for elderly patients with displaced intra-articular distal~     radius fractures.~   "
42544|NCT03009877|"~     Optiflow™ may provide an opportunity to prolong apnea time in the morbidly obese patient~     population. This study will examine whether Optiflow can do this, and compare the~     pre-oxygenation with Optiflow to the pre-oxygenation achieved with face mask.~   "
42545|NCT03009864|"~     This study is a randomized, double-blinded, placebo-controlled clinical trial on type 2~     diabetic Kidney Disease in early stage ( microalbuminuria excretion rate = 20-200mg/min) to~     evaluate the therapeutic effect of tang shen prescription. 632 participants will be recruited~     for the study, all of whom had type 2 diabetes, serum creatinine concentrations is normal,~     and no evidence of non-diabetic renal diseases. The subjects will be randomized to treatment~     with either tang shen prescription or placebo.~   "
42546|NCT03009851|"~     The goals of the proposed research were to:~        1. describe the person and environment characteristics and activity patterns of residents~          in long-term care (LTC) facilities;~        2. modify the evidence-based, occupation-based cultural heritage intervention (OBCHI)~          grounded on the results of Aim 1;~        3. test the effectiveness of the OBCHI intended to facilitate adaptation to relocation into~          LTC facilities relative to a usual activities group;~        4. determine the cost-effectiveness of the intervention conducted by in-house staff~          compared to the control group; and~        5. examine person and environment factors as potential moderators of the relationship~          between treatment condition and adaptation outcomes.~   "
42547|NCT03009838|"~     Polycystic ovary syndrome is the major cause of anovulatory infertility. Clomiphene citrate~     is the most commonly used oral agent for ovulation induction in this group, but there are~     some drawbacks with the use of it.~   "
42551|NCT03009786|"~     The main objective of this study is to achieve cross-cultural and psychometric validation of~     the Xerostomia Inventory initially developed in English language into French Language. This~     will be achieved in two stages: First, cross-cultural validation, and a second, psychometric~     validation The cross-cultural validation will be performed according to the methodology of~     the Institute for Work and Health, according to the recommended six phases. In a second step,~     the psychometric validation will be done using longitudinal study. Indeed, an observational,~     longitudinal, and prospective study will be set up. Analysis of the results will help define~     the feasibility and acceptability of the tool, its validity (content validity, perceived~     validity, construct validity, concurrent validity, and discriminant validity), its~     reliability (internal consistency and reproducibility over time). Longitudinal follow-up of~     patients is expected to also assess the predictive validity and responsiveness.~   "
42552|NCT03009773|"~     Stroke is the leading cause of severe disability in adults. The first cause of alterations in~     the quality of life and autonomy in these patients are disorders of walking and the balance.~     They are the leading cause of falls responsible for important medical, surgical and economic~     complications as well as a reactionary social isolation.~      The techniques of rehabilitation of walking to the subacute phase of a stroke are usually~     based on automatic walking.Off walking is a complex activity usually performed in everyday~     life in association with multiple tasks. It is therefore interesting to re-educate walking in~     dual task or even in multitasking.~   "
42553|NCT03009760|"~     The purpose of this study is to compare the pharmacokinetics and pharmacodynamics of CJ-12420~     after single and multiple dose administration according to H. pylori infection.~   "
42554|NCT03009747|"~     This research plans to collect rectal cancer patients after sphincter-preserving surgery from~     14 institutions in China mainland, observe the incidence and risk factors about bowel~     dysfunction after operation.~   "
42555|NCT03009734|"~     AntibioTx is developping ATx201 as a topical product for treatment of skin infections,~     including infected atopic dermatitis.~   "
42556|NCT03009721|"~     The purpose of this study is to investigate the effectiveness and safety of Olostar Tab in~     patients with essential hypertension and dyslipidemia~   "
42557|NCT03009708|"~     Traditionally known for their role in haemostasis, platelets have also an immune role.~      Platelets play a key role in immune mediator secretion, and interact with innate and adaptive~     immune cells, contributing to the fight against pathogens, as viruses.~      Cytomegalovirus (CMV) is responsible of allograft patients' serious infections, because of~     the induced immune depression. Platelets activation for patients is not determined during the~     post-graft period, and platelet induced inflammation following a CMV infection is not~     described.~   "
42558|NCT03009695|"~     Obesity is a metabolic disease that has reached epidemic proportions. Insofar no long-term~     effective drug treatment was developed for obesity. Lyfe style modulation and bariatric~     surgery are the only interventions with a limited rate of success. Obesity is due to several~     factors, mainly linked to a neurophysiological mechanism of food addiction. The use of~     repetitive deep Transcranial Magnetic Stimulation (dTMS) was proposed to reduce appetite and~     food craving in obese subjects, leading eventually to a weight reduction. dTMS was already~     tested successfully in other forms of addiction (smoking, alcohol, cocaine) and the~     usefulness of dTMS in the treatment of food addiction, and therefore in obesity, was~     hypothesized. End-points of this research will be: 1) effect on food craving; 2) acute and~     chronic effects on blood level of hormones acting on the appetite regulation; 3) chronic~     effects on body weight. The demonstration that a safe, non-invasive and repeatable~     methodology can treat obesity reducing food craving and modulating appetite/satiety hormones~     secretion will constitute a cornerstone in translational medicine of metabolic diseases.~   "
42559|NCT03009682|"~     This study is a single arm, multi-center phase II study of olaparib monotherapy in patients~     with relapsed small cell lung cancer (SCLC) harboring HR pathway gene mutations not limited~     to BRCA 1/2 mutations, ATM deficiency or MRE11A mutations as second or third line~     chemotherapy.~      Target subject population:~      Patients with small cell lung cancer that have progressed following first-line platinum-based~     therapy. Patients must have imaging confirmed progression on 1st line chemotherapy for SCLC~     treatment, which must have contained platinum-based regimen, with at least one measurable~     lesion per RECIST 1.1.~   "
42560|NCT03009669|"~     To assess the value of using pleth variability index(PVI) to monitor the patient's~     intra-operative volume status continuously by observing the application of stroke volume~     variation(SVV) and PVI and their correlation in patients undergoing intestinal tumor~     surgeries.~   "
42561|NCT03009656|"~     The emergency setting for acute neurological conditions, such as stroke, is peculiar due to~     time pressure and limited resources for further diagnostics. Clinical skills are essential~     for swift and accurate bedside diagnosis and thus are the basis for early and correct~     treatment. This is especially evident in the context of computed tomography being the~     standard neuroimaging method world-wide with its limitations for detecting smaller infarcts,~     strokes in the posterior fossa and reduced sensitivity for stroke mimics, such as epileptic~     seizures or migraine aura. To date, the accuracy of clinical bedside diagnosis of stroke by~     neurologists verified by magnetic resonance imaging (MRI) in the emergency setting has not~     been studied in detail. In order to improve clinical diagnosing and future treatment it is~     essential to quantify the accuracy of clinical diagnosis of stroke in the emergency setting~     (how good are neurologists?) and to assesses whether there are any differences between~     experienced staff neurologists and junior physicians.~   "
42562|NCT03009643|"~     Hypoxemia is a common complication after aortic surgery. As this complication has an adverse~     effect on the postoperative course of the patient, early treatment is important; however, the~     mechanism of hypoxemia after surgery for acute aortic dissection remains unclear. Recently,~     the investigators found that inhaled Nitric Oxide can improve the oxygenation in some of~     these patients. The investigators are trying to evaluate the effectiveness and safety of~     inhaled Nitric Oxide in patients with refractory hypoxemia after aortic surgery.~   "
42563|NCT03009630|"~     The objective of the study was to evaluate the efficacy and safety of electromagnetic~     navigation bronchoscopy (ENB) guided radiofrequency ablation (RFA) for the treatment of~     early-stage peripheral lung cancer.~   "
42566|NCT03009591|"~     Introduction: The common clinical manifestations of hemophilia are skeletal muscle bleeds,~     especially hematomas and hemarthrosis. Repeated episodes of joint bleeding in certain joints,~     causing a progressive joint deterioration. Secondary disorders to this joint degeneration~     include: biomechanical alterations, loss of range of movement and periarticular muscle~     atrophy.~      Design. A prospective, multicenter and longitudinal pilot study to evaluate the efficacy of a~     treatment protocol with fascial therapy applied in patients with hemophilic arthropathy of~     the elbow.~      Aimed: To evaluate the safety and efficacy of a physiotherapy treatment by fascial therapy in~     patients with hemophilic arthropathy of the elbow Patients: A total of 60 patients with~     hemophilia and prophylactic treatment will be recruited for inclusion in the study. Patients~     will be recruited in 6 centers, from different regions of Spain.~      Intervention: Each session will last approximately 50 minutes, with three physiotherapy~     sessions taking place over a period of 3 weeks. The treatment program includes 11 maneuvers~     that must be administered bilaterally:~      Measuring instruments and study variables: goniometric evaluation (range of movement); visual~     analog scale (joint pain); Haemophilia Joint Health Score (joint status); DASH Questionnaire~     (functionality of upper limbs); SF-36 Questionnaire (perception of quality of life). At the~     same time, the study will allow to determine joint bleeding caused by applied physiotherapy~     treatment.~      Expected results: First, it is intended to demonstrate the safety of this physiotherapy~     technique in patients with hemophilia. Likewise, an improvement in the perception of elbow~     pain and joint mobility is expected. An improved functionality of the upper limb is also~     foreseen and with it, an enhanced perception of quality of life of these patients.~   "
42567|NCT03009578|"~     Iron deficiency may result from inadequate dietary intake, achlorhydria or excessive~     ingestion of proton pump inhibitors, parasitic infestations, chronic infections and repeated~     pregnancies. Iron supplementation of antenatal patients is a basic tenet of antenatal care~     programmes in numerous developing and underdeveloped nations.~      Postpartum anemia is defined as hemoglobin of less than 11.5 gm% during the postpartum~     period. The prevalence of postpartum anemia varies from 4 - 27%. Chronic iron deficiency due~     to inadequate intake/ lack of iron supplementation during pregnancy, repeated pregnancies and~     postpartum hemorrhage are important causes of postpartum anemia~   "
42568|NCT03009565|"~     Background: The human gastrointestinal system is populated with a variety of symbiotic~     microorganisms, namely microbiota. The microbiome is the total genetic data of the~     microbiota. The human gut microbiota interacts extensively with the host through metabolic~     exchange; thereby contribute to a variety of metabolic and immunologic mechanisms in the~     human body. Coronary artery disease (CAD) is major cause of morbidity and mortality worldwide~     and is a major field of interest in microbiota research. There have been several findings~     that connect the gut microbiota to CAD pathophysiology, but these data relates solely to the~     interaction between human gut microbiome and cardiovascular risk factors. As far as known ,~     data regarding patients who already developed CAD is lacking.~      Aims: To investigate gut microbiota of patients with CAD, thereby allowing the adjustment of~     personalized treatment by changing the pro-atherosclerotic environment in the gut.~      Methods: Study participants will include patients arriving to Rabin Medical Center with~     suspected CAD. Patients will provide medical, lifestyle, and nutritional questionnaires.~     Vital signs measurements will be taken as well as fecal samples and/or rectal swabs. Blood~     samples will be drawn to measure blood chemistry including lipid profile and~     trimethylamine-N-oxide (TMAO) levels. Patients will undergo cardiac CT and/or cardiac~     catheterization in accordance with the decision of the cardiologist to evaluate and/or treat~     CAD. Genomic DNA will be extracted from stool samples for Microbiome analysis.~      Innovation: The hypothesis is that there is a unique microbiota pattern in patients with~     coronary atherosclerosis, which may contribute to the pathogenesis and/or expression of CAD.~     Knowing the unique microbiota in patients with coronary disease, would render it as novel~     target for treatment, either primary or secondary prevention.~      Collaboration: Between Cardiology department at Rabin Medical Center and the lab of Prof.~     Eran Segal located at the Weizmann Institute of Science. The collaboration between these two~     groups will combine the clinical expertise of treating cardiac patients with novel scientific~     technology and concept.~   "
42569|NCT03009552|"~     The overall objective of the study is to determine whether speckle tracking echocardiography~     presents additional prognostic value to the routine assessment (clinical and~     echocardiographic) in patients admitted with acute decompensated heart failure (ADHF) at the~     emergency department. Specific objectives: 1 - To evaluate the association between changes in~     the cardiac contractile mechanics (by serial measurements of strain, strain rate,~     displacement velocity, rotation and ventricular torsion) with clinical outcomes in ADHF. 2 -~     Evaluate the possible association of these parameters with biomarkers of neurohormonal~     activity, myocardial injury, fibrosis and myocardial remodeling, inflammatory activity, and~     cardiorenal syndrome.~   "
42570|NCT03009539|"~     The purpose of this study is to test the relative effectiveness of a Hispanic-specific~     eHealth intervention, e-Health Familias Unidas, in preventing and reducing drug use, sexual~     risk behaviors, and STIs among Hispanic youth in primary care. Families will be recruited~     through four pediatric primary care settings. Pediatric staff and research team members,~     including nurse assistants and mental health professionals, will implement eHealth Familias~     Unidas.~   "
42571|NCT03009526|"~     This study aims to compare the efficacy of monthly IPTp-DP with monthly IPTp-SP to determine~     if IPTp-DP is associated with a reduction in malaria infection at delivery among HIV-negative~     women in an area with high levels of SP resistance in Malawi.~   "
42572|NCT03009513|"~     An open label, one sequence study to investigate the pharmacokinetic drug interaction between~     Teneligliptin and Glimepiride in healthy male subjects~   "
42573|NCT03009500|"~     The purpose of this study is to evaluate three different injectable solutions used to block~     ankle nerves to manage ankle pain. The current standard of medical care is to inject a~     combination of local anesthetics and steroids around injured nerves. There is evidence that~     injection of local anesthetic (without the steroid) can calm the injured nerve and provide~     pain relief from a few days up to a few months. Injection of sterile salt water also has the~     potential to provide pain relief by breaking scar tissue around the nerve thereby relieving~     compression. Injections of local anesthetic and steroids around injured nerves have been used~     for many years to provide relief of pain but the specific reason is not well known for this~     benefit.~      There are three possibilities: 1) Steroids can reduce inflammation and calm the nerves, 2)~     local anesthetics can have similar actions but with shorter duration (few days), and 3)~     injection of any solution can break scarring around an injured/compressed nerve.~      The study will compare pain relief and possible adverse effects from these three different~     solutions. This study will help provide definitive answers regarding pain relief and possible~     adverse effects of the three solutions. This, in turn, will determine the best possible~     option for injection in patients with nerve-related injury pain.~   "
42574|NCT03009487|"~     A multi-center, randomized, double-blind, phase III clinical trial to evaluate the efficacy~     and safety of Olmesartan/Amlodipine/Rosuvastatin combination treatment in patients with~     concomitant hypertension and hyperlipidemia~   "
42575|NCT03009474|"~     To compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and~     Exforge® 5/160mg, Crestor 10mg in healthy male volunteers.~   "
42748|NCT03007225|"~     This study aimed to to compare the conventional transarterial chemoembolization (cTACE) with~     chemoembolization using doxorubicin drug eluting beads (DEB-TACE) for the treatment of~     hepatocellular carcinoma regarding short term efficacy and safety in first 3 months after~     embolization~   "
42576|NCT03009461|"~     According to the Barcelona clinic liver cancer (BCLC) staging treatment guideline, sorafenib~     is recommended for Hepatocellular Carcinoma (HCC) with Portal Vein Tumor Thrombosis (PVTT),~     but HCC with major PVTT (in the main trunk or 1st-order branches of the portal vein) did not~     benefit much from sorafenib in previous studies. There is no established standard treatment~     for HCC patients with major PVTT, the investigators conducted a randomized, phase 2 study to~     investigate the survival benefit of sorafenib plus Hepatic arterial infusion chemotherapy~     (HAIC) with Oxaliplatin and Fluorouracil versus sorafenib for Hepatocellular Carcinoma with~     Major Portal Vein Tumor Thrombosis.~   "
42577|NCT03009448|"~     Analysis of recent studies show that researchers find it hard to distinguish between Late~     Onset Depression, a first diagnosed major depressive episode which occurs at old age, and~     Early Onset Depression, a depressive episode at old age with a history of previous episodes.~     Since current data, about the phenomenology and etiology of Late Onset Depression, lake~     conicity it is unclear whether this phenomena should be considered as a distinct subtype of~     depression. Nevertheless, the wide spread assumption is that Late Onset Depression has a~     stronger correlation with brain damage and environmental risk factors such as the common~     losses at old age and weaker correlation with family history and genetics when compared to~     Early Onset. Although many researchers consider brain damage to have the main contribution to~     the emerge of Late Onset Depression, the fact that depression has a negative effect on one's~     health supports the claim that it might be the result and not the rick factor. Since Late~     Onset Depression correlates with the common losses at old age, the investigators propose that~     an existential approach that deals with one's meaning, freedom, responsibly and death, might~     be more appropriate. Thus, the investigators ask how do older adults experience depression~     which they face for the first time in old age? Current study will seek to understand older~     adults' experience of Late Onset depression through existential paradigm by using a semi~     constructed interview.~   "
42578|NCT03009435|"~     Introduction:~      The frequency of fetuses in occiput posterior position during labor is approximately 20 %, in~     which 5% remain occiput posterior at the end of labor. Occiput posterior position is~     associated with higher risks of caesarean deliveries and operative vaginal deliveries. The~     manual rotation to promote rotation from a posterior to an anterior position has been~     proposed to reduce the extraction rate. There is no randomised trial comparing the effect of~     manual rotation and expectant management. We propose a protocol for a prospective,~     monocentric, randomised controlled clinical trial in order to show that the rate of~     spontaneous vaginal delivery is higher with manual rotation of occiput posterior position~     than with an expectative management.~      Methods:~      Every 37 weeks with a singleton pregnancy with a clinical occiput posterior position~     suspicion confirmed by a transabdominal ultrasound at full dilatation will be eligible.~     Participants will be randomised to either prophylactic manual rotation (experimental group)~     or expectative management (control group). Based on an alpha value of 0.05 and gaining 20%~     for spontaneous vaginal delivery, 238 participants will need to be enrolled.~      The primary outcome will be spontaneous vaginal delivery. Secondary outcomes will be~     operative delivery rate (caesarean section , vacuum or forceps deliveries), significant~     maternal and perinatal mortality/morbidity.~      Analysis will be by intention-to-treat averaging a 24-month period.~   "
42579|NCT03009422|"~     The investigators will compare the common treatment for cutaneous leishmaniasis with~     intra-lesional Pentostam to fractional CO2 laser with topical application of Pentostam.~      Outcome will be final scar appearance assesd by two dermatologist and pain measurement by~     VAS.~   "
42580|NCT03009409|"~     Closed-loop control of anesthesia involves using feedback from a measure of clinical effect~     to continuously adjust drug infusion rates. As a result, anesthetic drugs are delivered at a~     variable rate that is frequently personalized to each individual patient. The aim is to~     provide greater stability at an optimal depth of anesthesia, reducing the occurrence of~     under- or overdosing, with the goal of ultimately improving patient outcomes.~      The purpose of this randomized, controlled equivalence trial is to compare controller~     performance during closed-loop controlled induction and maintenance of total intravenous~     anesthesia, using iControl system, with the addition of a low (analgesic) dose of ketamine~     versus saline control.~   "
42581|NCT03009396|"~     An open label extension to the RHB-104-01 Study.~   "
42582|NCT03009383|"~     The purpose of this study is to determine whether a bedside portable endoscopy is effective~     in identifying the esophageal foreign body in the emergency room.~   "
42583|NCT03009370|"~     The purpose of this study is to determine whether ovarian reserve is related to recurrent~     pregnancy loss~   "
42584|NCT03009357|"~     The study is a single-center prospective cohort study of clinical application of continuously~     monitored data by wearable activity trackers in the patients with thyrotoxicosis. The purpose~     of the study is to evaluate the association between parameters of pulse rate, activity, and~     sleep from wearable activity trackers and the thyrotoxic status along with the treatment.~   "
42585|NCT03009344|"~     This is a multicenter, single-arm, open-label, Phase 1 study to assess the tolerability,~     safety, pharmacokinetics, and preliminary anti-tumor activity of tazemetostat in participants~     with relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL).~   "
42586|NCT03009331|"~     The study comprises two different objectives. Longitudinal description of postoperative~     pulmonary dysfunction in the cardiothoracic surgery patient, and the comparison of two~     different lungrecruitment strategies.~   "
42587|NCT03009318|"~     MET PET and MRS are often performed as imaging tool for the differential diagnosis of~     gliomas. But both techniques have limitations causing misdiagnosis; thus, the investigators~     tried to combine these two imaging tools to study whether the combination of MET PET and MRS~     could raise the diagnosis ability of the radiological diagnosis of gliomas.~   "
42588|NCT03009305|"~     The study aims to describe hemodynamic effects of lower body negative pressure (LBNP).~        1. If and how changes in cerebral oxygen saturation (StO2) measured by near infrared~          spectroscopy (NIRS) relate to changes in blood flow in the carotid arteries during~          progressive LBNP.~        2. If and how mean systemic filling pressure (MSFP) can be measured by brief occlusion of~          blood flow to an arm and if this relates to LBNP-level.~        3. If and how pulse pressure variations and photoplethysmographic amplitude variations~          during positive expiratory pressure (PEP) and continuous positive airway pressure (CPAP)~          relate to LBNP-level.~   "
42595|NCT03009214|"~     This is a two part Phase I/Ib, open-label, non-randomized and multi-center, dose escalation~     study with a 3+3 design (Part 1) and an expansion cohort at the Maximum Tolerated Dose~     (MTD)/Recommended Phase 2 Dose (RP2D) (Part 2). If MTD is not reached in Part 1, RP2D will be~     determined after completion of Part 1 considering safety and tolerability, also beyond the~     dose limiting toxicity (DLT) period, pharmacokinetic (PK) and pharmacodynamic (PD) results.~   "
42596|NCT03009201|"~     This phase Ib trial studies the side effects and best dose of the CDK4/6 inhibitor ribociclib~     when given together with doxorubicin in treating patients with soft tissue sarcomas that has~     spread to other places or that cannot be removed by surgery. Ribociclib may stop the growth~     of sarcoma tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as doxorubicin, work in different ways to stop the growth of tumor cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Giving ribociclib for a week prior to standard treatment with doxorubicin may work~     better in treating patients with soft tissue sarcoma.~   "
42597|NCT03009188|"~     Axenfeld-Rieger syndrome (ARS) is a rare autosomal dominant disorder, characterized by~     anterior segment abnormalities and systemic abnormalities. To date,two major genes, forkhead~     box C1 (FOXC1) on chromosome 6p25 and pituitary homeobox 2 (PITX2) on chromosome 4q25, have~     been demonstrated to cause ARS. In this study, we performed complete ophthalmologic~     examinations and analysis of FOXC1 and PITX2 of a Chinese family with ARS.~   "
42598|NCT03009175|"~     The purpose of the study is:~        -  To evaluate the Heart Failure Risk Status (HFRS) feature performance.~        -  To establish the feasibility of remote follow-up in which patient risk triaging is~          performed by nurse-led review of HFRS feature as supplemental information.~   "
42599|NCT03009162|"~     This is a multi-center, open-label, non-randomized, parallel-group, adaptive, single dose~     study.~      This study will enroll up to 32 participants using an adaptive design that can include up to~     3 groups of 8 participants with different degree of renal impairment and one group of 8~     control participants with normal renal function.~      Screening data will be reviewed to determine participant eligibility. Participants who meet~     all inclusion criteria and none of the exclusion criteria will be entered in the study.~      First, approximately 16 participants will be enrolled with severe renal impairment and~     matched participants with normal renal function. There will be 8 participants in each of the~     following groups based on renal function at screening:~        -  Group 1: Healthy participants with normal renal function (estimated glomerular~          filtration rate [eGFR] ≥ 90 milliliters per minute per 1.73 meters squared~          [mL/min/1.73m²])~        -  Group 2: Severe renal impairment participants (eGFR < 30 mL/min/1.73m²) Based on safety~          and pharmacokinetic (PK) results from participants with severe renal impairment (Group~          2), Group 3 (Moderate Renal Impairment) and Group 4 (Mild Renal Impairment) will be~          enrolled if substantial change in the exposure of lasmiditan is observed in participants~          with severe renal impairment.~   "
42600|NCT03009149|"~     H1 - Aerobic exercise will expect to experience significant increase on CD4 counts , reduced~     viral load , improve psycho-social well being among people living with HIV /AIDS.~   "
42601|NCT03009136|"~     The aim of this study is to investigate the short and long term efficacy and the safety of~     SCRT treatment for PAR~   "
42602|NCT03009123|"~     The rationale for investigating the hypothesis that there is an association between erectile~     dysfunction (ED) and the subsequent development of prostate cancer is based on three~     assumptions: 1) baseline ED is common in most if not all of the cross-sectional studies in~     men with prostate cancer; 2) the development of ED and prostate cancer may have certain~     shared common risk factors; and 3) the use of testosterone for the treatment of ED has been~     suspected to be associated with prostate cancer development. Controversy exists over whether~     men with ED have an increased risk of subsequent prostate cancer. Few studies have evaluated~     the risk of developing prostate cancer for men with ED. The investigators, therefore,~     conducted a population-based longitudinal study with eight years' follow-up to examine this~     association and to evaluate the magnitude of the risk.~   "
42603|NCT03009110|"~     The Prophylactic Negative Pressure Wound Therapy in Obese Women at Cesarean Trial is a large~     pragmatic multi-center randomized clinical trial designed to evaluate the effectiveness,~     safety and cost-effectiveness of prophylactic negative pressure wound therapy (NPWT) - a~     closed, sealed system that applies negative pressure to the wound surface via a single-use,~     battery-powered, portable device - to decrease surgical site infections (SSIs) in obese~     women.~   "
42604|NCT03009097|"~     Periodontitis is a major oral health problem which leads to the progressive destruction of~     periodontal ligament and alveolar bone with pocket formation, recession or both. The ultimate~     goal of periodontal therapy is to regenerate the lost periodontal tissue. The most common~     form of regenerative periodontal therapy is the use of bone grafts which stimulate bone~     formation by the processes of osteoinduction and osteoconduction.~      Statins are a group of lipid lowering drugs which inhibit bone resorption by inhibition of~     the enzyme HMG-CoA reductase. They also stimulate new bone formation by local stimulation of~     BMP-2, a major bone growth regulatory factor. They also have anti-inflammatory and anti~     oxidant properties.~      Very few studies exist evaluating the beneficiary effects of grafts if combined with the~     statins which might enhance the regeneration by bone grafts.~      Hence, the present study was carried out in an attempt to comparatively evaluate clinically~     and radiologically, the efficacy of atorvastatin gel as an adjunct to allograft in the~     treatment of intrabony defects.~   "
42605|NCT03009084|"~     The purpose of this study is to investigate the communication and data sharing between the~     primary care physician and the nephrologist about patients with chronic kidney disease. Also~     therapeutic interventions that change behavior and telemonitoring of the blood pressure will~     be explored and compared to the usual care. The most important aim of this study is to~     improve the quality of care for the patient with chronic kidney disease in cooperation with~     the primary care physician and the nephrologist.~   "
42606|NCT03009071|"~     A pilot multicenter randomized controlled trial will be conducted to evaluate the clinical~     effectiveness, cost-effectiveness, and safety of Doin (conduction exercise) with acupuncture~     for chronic neck pain patients compared to acupuncture alone.~   "
42749|NCT03007212|"~     Portal vein tumor invasion (PVT) is a common complication in HCC. the studyb Aimed to assess~     the outcomes after TACE in patients with branch PVT regarding Child classification,~     radiological response and 1 year survival.~   "
42608|NCT03009045|"~     The problem of interest is that doctors are looking for new antibiotic treatments for bone~     and joint infections. Treatment for bone and joint infection is not standardized, which~     allows a wide range of antibiotic therapy to potentially be given. A type of bacteria called~     S. aureus is the most common cause of bone and joint infection. Methicillin resistant S.~     aureus (MRSA) is a type of bacteria that is not killed by some antibiotics, and it is~     increasingly common in U.S. and non-U.S. medical centers. This problem will be studied by~     investigating whether an antibiotic called tedizolid is tolerable, safe and effective to~     treat bone and joint infections.~   "
42609|NCT03009032|"~     Late diagnosed HIV-infected subjects show impaired immunological recovery resulting in a~     greater risk of clinical progression. Gut bacteria metabolism appears to impact immune~     recovery in HIV-infected subjects, and while nutritional interventions with prebiotics and~     probiotics seem to exert immunological effects, the clinical implications in this key~     population remain unknown. This is a pilot multicenter randomized placebo-controlled, double~     blind clinical trial in HIV-infected ART-naive subjects with <350 CD4 T cells/mm3 or AIDS.~     Participants will be randomized (1:1) to either the synbiotic nutritional supplement PMT25341~     or placebo for 48 weeks, each in combination with first-line ART. Primary outcomes will be~     safety and immunological recovery. Secondary outcomes will include changes in fecal~     microbiota structure and plasma inflammatory markers.~   "
42610|NCT03009019|"~     Efficacy, Tolerability, and Safety of DFN-15 in episodic migraine with or without aura, being~     conducted at multiple centers in the United States~   "
42611|NCT03009006|"~     The aim of this prospective in vivo randomized clinical trial to evaluate influence of~     combination of calcium Hydroxide (CALCIPAST Paste, Poland) and chlorhexidine Gel 2%~     (Gluco-Chex 2%, Cerkamed, Poland) in comparison to calcium hydroxide paste (CALCIPAST Paste,~     Poland) as Intracanal Medication on post operative pain (incidence, degree, duration) and~     reduction of bacterial endotoxins (quantitative) after endodontic treatment in single rooted~     necrotic teeth.~      According to the inclusion criteria the patients enrolled in the study and allocated randomly~     into three groups either combination of calcium hydroxide paste intracanal medication with 2%~     chlorhexidine gel. (group A) or calcium hydroxide paste intracanal medication only (group B)~     or mechanical preparation without intracanal medications (group C) the endodontic treatment~     is done at two visits.~      The samples of endotoxin divided into three groups: after access (S1), after mechanical~     instrumentations (S2), after removal intracanal medication (S3), all samples taken by a~     sterile paper points introduced in the root canal for the working length for 60 seconds.~      firstly the patient's medical and dental history is taken. the patients assign on informed~     consent. and then anaesthetized and access cavity performed and root canal preparation is~     done by Revo-s system then irrigation and intracanal medication placement inside to canal.~     the patient's record the post operative pain in sheet with NRS after 4, 24, 48 hours and 2~     weeks after first visit. the operator will recall the patient to check the records~      second visit After 2 weeks from application of ICM, rubber dam will be applied then removal~     of the temporary dressing, then a sterile paper point (S3) will be introduced into the canals~     after irrigation and removal of the remnants of the intracanal medicament with the saline~     solution.~        -  Removal of the paper sample to determine the endotoxin concentration.~        -  The canals will be obturated by single cone technique using gutta percha point tapered~          0.4% (Gutta percha point, Revo-S MicroMega CO., LTD, France) corresponding to the final~          apical size of the file and the root canal sealer will be resin sealer (Adseal, META~          BIOMED CO., LTD, Korea).~        -  Pain will be assessed by numerical pain rating scale (NRS) after 14 days from the first~          visit (at the day of the Obturation) before the beginning of Obturation.~   "
42612|NCT03008993|"~     INTRODUCTION Our group previously demonstrated the feasibility of the Hucare Quality~     Improvement Strategy - HQIS, aimed at integrating into practice 6 psychosocial interventions~     recommended by international guidelines. This randomized trial is designed to assess whether~     the introduction of the strategy in oncology wards improves patient quality of life.~      METHODS AND ANALYSIS This is a multicenter, incomplete stepped-wedge cluster randomized~     controlled trial, where the intervention strategy is sequentially carried out in three groups~     of centers (clusters with 5 centers each) and in three equally spaced time periods (epochs)~     (every 4 months). The study also includes an initial epoch during which none of the centers~     is exposed to the intervention, and a final epoch when all centers will have implemented the~     strategy . The intervention is applied at a cluster level (unit of randomization) and~     assessed at an individual level with cross-sectional model. 720 patients will be included,~     i.e. 60 patients in each cluster for every detection epoch.~      Primary aim is to evaluate the effectiveness of the HQIS vs standard care in terms of~     improvement of at least one of two domains of HRQoL using the EORTC QLQ-C30 questionnaire,~     detected at baseline and 3 months after enrolment.~      The HQIS comprises three phases: 1) clinician training - to improve communication-relational~     skills and to instruct on the project; 2) center support - 4 on site visits by experts of the~     project team, aimed to introduce the project and boost motivation, instruct staff on how to~     implement recommendations, help with context analysis and identification of solutions; assess~     actual implementation in the center; 3) implementation of EBM recommendations.~      ETHICS AND DISSEMINATION Ethics committee review approval has been obtained from the Ethics~     Committee of Parma. Results will be disseminated at conferences, in peer-reviewed and~     professional journals intended for policymakers and managers.~   "
42613|NCT03008980|"~     Patients will be recruited from participating institutions prior to planned routine care EGD~     with WATS3D brush samples and forceps biopsies. Eligibility will be reviewed and patients who~     are potentially eligible for the study will be approached regarding the study. If interested,~     participants will be consented and proceed with routine care EGD. The study coordinator or~     other research personnel will document information from the routine care endoscopy as part of~     this research study. Follow-up information collected will include WATS3D cytology and forceps~     biopsy pathology results from any routine care endoscopy performed during the course of~     participation in the study, any surgeries received and related to their condition, and any~     other care received as part of their condition. WATS3D samples will be sent to CDx~     Diagnostics for analysis.~   "
42614|NCT03008967|"~     This project will be a descriptive, hypothesis-generating study. The aim is to identify risk~     factors for poor response to rehabilitation programs after TJR and use these to identify~     patients who are most susceptible to poor outcomes in order to optimise appropriate~     rehabilitations strategies and rationalising the distribution of health care resources.~   "
42615|NCT03008954|"~     The FLOW (First Loss Of Weight) study is designed to assess the effects of repeated~     administration of GSP3, an investigational product, on body weight. It is a multicenter,~     randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study. FLOW is being~     conducted in 5 medical centers in Italy, Czech Republic, and Denmark, and will randomize 123~     overweight and obese adult males and females to receive either placebo, GSP3 (2.25g), or GSP3~     (3.75g) in addition to a hypocaloric diet (-600 kcal/day) for 12 weeks.~   "
42645|NCT03008564|"~     There has been dispute about the location at which the adductor canal block should be~     performed (3-6). Two Common approaches have been used for ultrasound guided adductor canal~     blocks with the 'point of entry' being:~        1. Point A: midway point between the ASIS and base of patella~        2. Point B: Point which is 2-3 cm proximal to the site where the femoral artery becomes the~          popliteal artery as it traverses away from the sartorius muscle towards the femur at the~          adductor hiatus (2)~      We want to determine ultrasound anatomy in healthy volunteers by:~        1. Measuring the distance between Point A and Point B~        2. Studying the ultrasound anatomy at Point A and B - Determine their location with respect~          to the adductor canal and femoral triangle.~      This will allow us to determine which is the best site for performing an adductor canal block~   "
42616|NCT03008941|"~     Altered interplay between gut mucosa and dysbiotic bacteria during HIV infection seems to~     contribute to chronic immune dysfunction. Manipulation of the intestinal microbiota with~     nutritional interventions exert limited immunologic effects, but a deep understanding of how~     these interventions could ameliorate gut dysbiosis and influence health among HIV-infected~     individuals remain unexplored. In this Phase I clinical trial, 30 HIV-infected subjects on~     effective ART with evidence of persistent immune dysfunction, indicated by a CD4/CD8 ratio<1~     will be included and randomized to either repeated low-dose oral fecal microbiota~     transplantation or placebo during 8 weeks. The primary outcome will be safety. Secondary~     outcomes will include changes in CD4+ T cell counts, CD8+ T cell counts, CD4/CD8 ratio,~     inflammatory markers, T cell activation and markers of enterocyte barrier function through~     week 48. Engraftment on host microbiota will be examined using Illumina sequencing of the~     V3-V4 16S RNA, and changes in bacterial metabolism and in the plasma metabolite fingerprint~     will be studied by combination of untargeted mass spectrometry and two different and~     complementary separation techniques in bacterial and plasma samples.~   "
42617|NCT03008928|"~     New technologies offer potential ways to provide and deliver preventative interventions. With~     respect to unhealthy alcohol use, offering people tools to assess and manage their risk at~     any given time using their smartphone may represent an additional opportunity to disseminate~     preventative interventions. Nevertheless, there is a lack of knowledge on the acceptability~     and efficacy of smartphone applications for unhealthy alcohol use. Alcooquizz, a smartphone~     app, has been previously evaluated using a before/after design without randomization, with~     participants reporting reductions in drinking over time. The current trial proposes to~     conduct an RCT, comparing reductions in alcohol consumption between participants provided~     access to Alcooquizz to a no intervention control.~      Participants will be recruited through Amazon's MTurk crowdsourcing platform. Potential~     participants identified as problem drinkers based on an initial survey will be invited to~     complete another survey in 6 months time. Those who agree to be followed-up will be~     randomized to be provided a link to download the Alcooquizz app or to a no link control~     condition. At six-months post-baseline, the MTurk portal will be used to send invitation~     emails that contain a link to the follow-up survey that asks about their drinking and their~     impressions of the app. The primary hypothesis to be tested is that participants receiving~     access to the Alcooquizz app will report a greater level of reduction in number of drinks in~     a typical week between the baseline survey and six-month follow-up as compared to~     participants in the no information control condition.~   "
42618|NCT03008915|"~     The aim of this study is to test whether aspirin improves endothelial function in alpha-1~     antitrypsin deficiency-associated lung disease, measured by pulmonary microvascular blood~     flow on magnetic resonance imaging (MRI) and with apoptotic endothelial microparticles.~   "
42619|NCT03008902|"~     We are studying how spine movement changes with age, and when people have vertebral fractures~     (cracks in the bones of the spine) or hyperkyphosis (a forward stooped posture).~   "
42620|NCT03008889|"~     The purpose of this study is to demonstrate the feasibility of a 9-week, randomized trial of~     N-acetylcysteine (NAC) compared to placebo in 14 children (age 5 to 12 years) with Autism~     Spectrum Disorder (ASD) and a moderate level of repetitive self-injurious behavior (SIB).~     Additional aims are to evaluate the positive predictive value of a screening method to~     classify children with automatically maintained self-injurious behavior; to evaluate the~     preliminary efficacy of NAC for reducing repetitive SIB in children with ASD; and to evaluate~     biomarkers and possible mechanisms of action of NAC in children with ASD.~   "
42621|NCT03008876|"~     This is a randomized controlled trial to evaluate the efficacy of IV acetaminophen versus IV~     ibuprofen in closing a hemodynamically significant patent ductus arteriosus in preterm~     infants.~   "
42622|NCT03008863|"~     1. The investigators will design, test and implement a education curriculum for anesthesia~          residents teaching geriatric anesthesiology.~        2. The investigators will randomize 42 anesthesia residents so that half receive an~          innovative, e-learning curriculum while the other half receives the current standard~          curriculum. We will assess their medical knowledge, and the amount of anesthesia~          delivered to patients after the curriculum is implemented.~        3. The investigators will analyze any changes in clinical practice of residents in the care~          of elderly patients. Enrollment will be voluntary for all residents. Also, the~          investigators will not interfere with clinical management of any patients by residents~          which are done under direct supervision of faculty.~   "
42623|NCT03008850|"~     Shivering is a common post-anesthetic complication occurring in up to 65% of patients~     undergoing spinal or epidural anesthesia. Shivering may interfere with electrocardiogram,~     blood pressure and oxygen saturation monitoring. In addition, shivering increases oxygen~     consumption, carbon dioxide production and metabolic rate by up to 400%. Thus, it may result~     in problems in patients with low cardiac and pulmonary reserves. Preventing shivering could~     therefore result in better postoperative outcomes or reduce the incidence of post-surgical~     complications.~   "
42624|NCT03008837|"~     Given recent increasing opioid-related deaths and evidence showing against the use of opioids~     for non-malignant chronic pain, there is growing need for non-narcotic pain management.~     Fibromyalgia is a difficult to treat chronic pain condition that is often treated with~     opioids despite existing evidence. The prevalence of fibromyalgia is increased among Veterans~     returning from the gulf war and is already a significant burden in senior Veterans who may~     have suffered with chronic pain for decades already. Many treatment options for fibromyalgia~     carry intolerable side effects. PENFS (percutaneous electrical neural field stimulation) is a~     FDA-approved, non-pharmacologic therapy that is currently utilized within the military and VA~     system, but sufficient evidence regarding its outcomes and neural mechanisms have not been~     adequately investigated. An understanding of its neural underpinnings and analgesic effects~     could lead to 1) improvements in pain management and quality of life, 2) cost-savings and 3)~     development of new techniques to address pain.~   "
42646|NCT03008551|"~     This a randomised open-label parallel study involving women with polycystic ovary syndrome~     (PCOS). The patients will be randomised either to metformin 1500mg or empagliflozin 25mg~     daily for three months. The aim of the study is to examine the effect of empagliflozin on~     hormonal, metabolic and cardiovascular risk markers and quality of life in women with PCOS.~   "
42647|NCT03008538|"~     Studying the comparative effectiveness of socket preservation using autogenous bone graft~     versus MPM for implant insertion.~   "
42625|NCT03008824|"~     There is a rapidly escalating epidemic of obesity and type 2 diabetes across the world, with~     the fastest rise occurring in low- and middle-income countries. India not only has one of the~     highest rates in the world, but the disease starts at a younger age and lower levels of body~     weight than in UK white caucasians. Among city-dwelling Indians, approximately 8% of people~     aged 30-40 years already have diabetes. This is creating a heavy burden of disease and~     disability, and an intolerable economic burden through medical costs and lost earnings. Until~     now, efforts to prevent diabetes have mainly focussed on modifying the diet, lifestyle and~     activity of at-risk adults (for example those who are overweight, have a family history of~     diabetes or already have high blood sugar). However, recent research has indicated that~     factors acting in early life (during development in the womb) place an individual at risk of~     later diabetes. These include maternal malnutrition and low birthweight, and diabetes in the~     mother during pregnancy. Our research has shown that Indian mothers often have low vitamin~     B12 levels, which in turn causes high blood levels of a harmful metabolite (homocysteine). We~     have shown that these mothers get more diabetes in pregnancy. Their children are more likely~     to born with a low birth weight, and develop more body fat and higher plasma insulin levels~     during childhood, which are signs of higher diabetes risk in later life. The risk is~     increased further if the mother has normal or high status for another B vitamin, folate.~     Thus, we have shown, for the first time a link between a specific nutritional deficiency in~     the mother and diabetes risk in the next generation. One possible mechanism for the effect of~     maternal nutrition on risk of diabetes in her children is through epigenetic effects, whereby~     the nutritional environment during early development affects the switches that control gene~     expression. Since these switches are passed on via either parent, we think it is possible~     that paternal vitamin B12 status could also be important.~   "
42626|NCT03008811|"~     This study will compare efficacy and safety of pulmonary vein isolation using a cryoballoon~     catheter versus a radiofrequency ablation with a contact force sensing catheter for treatment~     of patients with persistent or longstanding persistent atrial fibrillation.~   "
42627|NCT03008798|"~     Prevention for the Restenosis of Intracranial artery Stent Implantation Treated with herbal~     medicine C117--PRISIT Trial~   "
42628|NCT03008785|"~     This study evaluate if 10 weeks of mixed exercise combined with isoflavones could have~     greater effects on climacteric symptoms than exercise alone in postmenopausal women. the~     participants will be randomly assigned to the group: placebo and exercise or 100mg of~     isoflavone and exercise.~   "
42629|NCT03008772|"~     To define the long-term incidence and frequency of ISR follow DES implantation. Compare the~     clinical presentation, treatment and intervention success among de novo coronary artery~     stenosis and DES ISR.~      Compare short- and long-term outcomes of de novo coronary artery stenosis and DES ISR,~     assessed by incidence of mortality, MACE, MI, and TLR/TVR at index hospitalization, 30 days,~     6 months, 1 year, 3 years, and 5 years, if available.~   "
42630|NCT03008759|"~     The literature recognizes that fluoride is the most widely used and studied means for dental~     remineralization. The use of fluoride toothpaste in brushing is considered more rational~     method for the prevention of caries. However, the current challenge of toothpaste is the~     substantivity, so new compounds have been introduced into these formulations. This study aims~     to evaluate the in vivo effect of fluoride dentifrice containing nanoencapsulated Fluoride~     (Nano-F) - in fluoride retention in saliva and dental plaque. A study of the clinical and~     laboratory type, crossover, double-blind, randomized will be held. After sample calculation,~     the total of 12 individuals aged between 18 and 35 years old, healthy, decayed, missing, and~     filled teeth index less than 6 and residents in brazilian northeast capital will be part of~     the sample. Fluoride bioavailability will be evaluated in the biofilm and saliva after the~     use of fluoridated weekly. The biofilm will be assessed on 1h and 12 h after brushing; and~     unstimulated saliva in times of 3, 15, 30, 45, 60 minutes and 12 hours after. It will be 3~     toothpastes: 50% Nanoencapsulated Fluoride, 100% Nanoencapsulated Fluoride and Free sodium~     fluoride. Between weeks of use, brushing will be extended washout (without fluoride) to avoid~     carryover effect. inferential data analysis will be carried out, considering the amount of~     alpha <0.05. So knowing that caries is a dynamic process, the largest fluoride retention in~     the oral fluids promoted by the Nanoencapsulated Fluoride may have important impact on Des-Re~     process and in the control of dental caries~   "
42631|NCT03008746|"~     Pseudomonas aeruginosa (PA ) is associated with chronic lung infections in patients with~     chronic obstructive pulmonary disease (COPD). Commensal flora (microbiota) in lung was~     recently described using high-throughput sequencing techniques (NGS). PA strains isolated~     during lung infection episodes of severe COPD patients often show resistance to antibiotics~     including imipenem that is mainly due to mutation in oprD. In collaboration with Harvard~     Medical School, the investigators have recently demonstrated that PA OprD mutant shows~     increased survival (fitness) and its virulence. This bacterium could be more likely to~     colonize. Colonization by PA OprD mutant could influence the pulmonary microbiota and may~     worsen disease evolution, particularly in terms of frequency of exacerbations. Our objective~     is to describe modification of pulmonary microbiota associated with PA colonization,~     including OprD PA mutant, in severe COPD patients. The investigators will correlate the~     microbiota modification to medical history. Stable severe COPD patients will be included.~     Three groups of patients will be sampled: 1) not PA colonized, 2) PA colonized and 3) PA OprD~     mutant colonized. Medical history will be recorded by the physician as usual and three~     samples will be performed: 1) sputum, 2) oral wash and 3) water used for oral wash. Regular~     bacterial culture will be performed and NGS will be performed also to characterize the~     microbiota.~   "
42632|NCT03008733|"~     The use of nerve ultrasound for the diagnosis and monitoring of neuromuscular diseases is a~     promising growing field (1). Non-invasive and painless, ultrasound provides additional data~     electroneuromyography (EMG), with a spatial resolution at least as good as MRI, while being~     easily accessible and inexpensive.The polyradiculoneuritis Inflammatory Demyelinating~     Chronicles (IPDC), Neuropathies Motrices in Multifocal Conduction Blocks (NMMBC) and~     neuropathy associated with anti-MAG antibodies are among the major chronic inflammatory~     neuropathies with an autoimmune etiology. The diagnosis of these pathologies is based on the~     clinic, diagnostic tests and EMG. The interest not only in the diagnosis, but also for~     monitoring these pathologies using ultrasound analysis nerves has been demonstrated recently~     in several studies. However the limited resolution of current ultrasound images do not allow~     detailed study of the internal structure of the nerves which could later help deepen~     knowledge in this innovative field and can better understand the pathophysiological mechanism~     of the evolution of these pathologies .~      To do this, the investigators have available a UHF ultrasound in the ultrasound department of~     the Nice University Hospital Pasteur Hospital 2 The investigators realize a descriptive~     analysis study, pilot, mono-centric, multi and prospective on patients followed in the center~     with a diagnosis of IPDC, a NMMBC or neuropathy with anti-MAG antibodies and control subjects~     matched by age and sex. All the patients and controls in this study will receive a briefing~     and must sign an informed consent.~      They realize an ultrasound study of the nerve, using an ultra high frequency ultrasound~     system that will allow the assessment of anatomical structures of nerve (size, structure,~     vascularisation and assessment booklets). Ultrasound data will, in a second stage, compared~     with the data obtained with the EMG and clinical scores obtained using clinical rating~     scales. 40 subjects will be included, divided into four subgroups: 10 subjects with a~     diagnosis of IPDC (1), 10 subjects with a diagnosis of NMMBC (2), 10 subjects with a~     diagnosis of neuropathy antibody-anti MAG (3) and 10 control subjects with no signs of~     neuropathy at the EMG examination.~   "
42633|NCT03008720|"~     Introduction: It is suggested that increased cortical activity, induced by cerebral~     stimulation associated or not with other rehabilitation techniques, may potentiate the motor~     and functional therapeutic effects in individuals with neurological deficits. Objectives: To~     evaluate the electrical activity of the anterior tibial muscle (TA) and postural control of~     individuals with hemiparesis due to stroke following treatment with transcranial direct~     current (tDCS) stimulation and functional electrical stimulation (FES), associated or~     isolated). (EMG) and postural control by the Balance Evaluation Systems Test (BESTest). Both~     of which were collected at four different time points: pre-treatment, immediately after 10~     treatment sessions, and 30 days follow-up after the interventions. Patients will be~     randomized into 4 experimental groups: tDCS anodic active + active FES+ active contraction~     TA, tDCS sham + active FES+ active contraction TA, tDCS anodic active+ placebo FES+ active~     contraction TA, tDCS sham+ FES sham+ active contraction TA. tDCS (2mA) will be applied over~     the motor (Cz) and cathodic vertex over the supraorbital region of the normal hemisphere and~     FES over hemiparetic TA by a researcher who will not be the one who will evaluate the~     anesthesia patient. The treatment will last 10 sessions, twice a week, with a time of 20~     minutes.~   "
42634|NCT03008707|"~     Laparoscopic peritoneal lavage (LPL) has recently been emerging as an effective alternative~     to laparoscopic sigmoidectomy (LS) in patients with complicated acute diverticulitis (CAD)~     (Modified Hinchey's classification grade II non-responder to conservative therapy and grade~     III). Aim of the study is to evaluate which surgical strategy, between LPL and LS, could give~     better results in patients with CAD~   "
42635|NCT03008694|"~     This study evaluates the effect of FDG-PET/CT for Simulation and Radiation Treatment Planning~     in oral Cancer patients. Progress-free survival (PFS) will be compared with historical~     control as defined in the protocol~   "
42636|NCT03008681|"~     The aim of the study was to determine the changes in Oral Health-Related Quality of Life~     (OHRQoL) in patients with juvenile idiopathic arthritis (JIA) and temporomandibular joint~     (TMJ) disorders who underwent functional therapy for 24 months to assess the age and sex~     group in which the functional therapy was most effective.~   "
42637|NCT03008668|"~     The investigators plan to undertake a rigorous multicentre randomised controlled trial,~     comparing acupuncture on sensitized acupoints versus non-sensitized acupoints, to test if~     acupuncture on sensitized acupoints may result in improved treatment outcomes in patients~     with Knee osteoarthritis (KOA).~   "
42638|NCT03008655|"~     BACKGROUND: Melasma is a chronic, often relapsing skin disorder, with poor long-term results~     from all current therapies.Q switched 1064nm Nd:YAG laser and intradermal tranexamic acid~     both showed efficacy on the treatment of melasma. However, no combination therapy of both be~     reported.~      OBJECTIVES: To compare the efficacy of low influence Q switched 1064nm Nd:YAG laser and low~     influence Q switched 1064nm Nd:YAG laser combined with intradermal tranexamic acid injection~     for melasma.~   "
42639|NCT03008642|"~     The optimized CO-Rebreathing is an efficient method to evaluate the red cell mass and has~     been used in the vast majority of studies in sport medicine. However, this method has never~     been evaluated on a large scale in the diagnosis of primitive or secondary polycythemia. The~     standard procedure to evaluate the red cell mass is based on isotopic measurement using~     Cr51-labelled red cells, but its lack of availability in many centers highlights the need for~     a non-invasive and rapid alternative method. The purpose of this study is to evaluate and~     validate the CO-Rebreathing method in this set of indications.~   "
42640|NCT03008629|"~     Background: Ingrown toenails are one of the most frequent nail disorders and can be treated~     with conservative or surgical approaches. Although discovered a long time ago, the available~     data are still very limited on the potential effectiveness of nail braces for ingrown toenail~     treatment.~      Objective: This study aimed to evaluate the efficacy of nail brace (combiped and podofix) for~     treatment of ingrown toenails.~   "
42641|NCT03008616|"~     This study evaluates the use of Digoxin immune fab in addition to expectant management in the~     treatment of severe preeclampsia as compared to placebo.~   "
42642|NCT03008603|"~     This is a prospective, single-arm study is to evaluate the safety, effectiveness and~     usability of the XACT device. Subjects undergoing CT-guided, minimally invasive percutaneous~     procedures in the interventional radiology suite, e.g., core biopsy, will participate in the~     summary. Clinical accuracy will be the primary efficacy endpoint. Usability and safety will~     also be evaluated.~   "
42643|NCT03008590|"~     Over 100 million Americans report chronic pain. Veterans are disproportionately affected for~     multiple reasons, including injuries and post-traumatic stress disorder. Treatment for~     chronic pain is a priority research area for the VA. One of the most common causes of chronic~     pain is osteoarthritis (OA). OA is attributable to wear and tear, but reasons for pain are~     complex. Inflammatory arthritis (IA) includes multiple severe diseases that affect 2-3% of~     persons and require treatment with immune-suppressive drugs to prevent joint destruction.~     Pain often persists despite effective treatment. Pain in arthritis results from multiple~     sources: inflammation, perception of pain in the joint, and interpretation of pain by the~     brain. Unfortunately, management of pain in arthritis remains a challenge. Low dose~     naltrexone is a widely used but unproven alternative approach to chronic pain. It is~     attractive for study because it is safe and is proposed to work on all three pathways that~     contribute to pain. A small but high-quality clinical trial is needed to determine whether to~     invest in definitive studies.~   "
42644|NCT03008577|"~     Neonatal hypothermia is associated with increased risk of mortality as well as multiple~     morbidities. The prior HEAT study conducted at our institution showed a difference in~     neonatal hypothermia with a change in ambient operating room temperature. The investigator's~     objective is to determine if an increase in ambient operative room temperature decreases the~     rate of neonatal morbidity. Operating room temperature will be randomized to the current~     institutional standard of 20°C (67°F) or a temperature of 24°C (75°F), on a weekly basis for~     a period of 1.2 years.~   "
42664|NCT03008317|"~     a split mouth randomized clinical trial that compares quantity and quality of bacterial~     adhesion under both PEEK versus cobalt chromium alloy denture base.~   "
42665|NCT03008304|"~     The aim of this study is the safety and efficacy of high-activity natural killer~     immunotherapy to small metastases of pancreatic cancer.~   "
42648|NCT03008525|"~     Vitamin D (VD) is a pleiotropic hormone, involved in many physiological processes including~     calcium and phosphorus absorption. The VD metabolism begin to be well-known and involves a~     hepatic hydroxylation (mediated by enzymes, which belong to the cytochrome P450 family)~     leading to the production of the 25(OH)D, which corresponds to the circulating form of the~     VD. After circulation in blood, the 25(OH)D is submitted to a second hydroxylation in the~     kidney resulting to the generation of 1,25(OH)2D, the active metabolite of VD. Numerous~     epidemiological studies reported an inverse relationship between obesity and circulation~     level of 25(OH)D. Several mechanisms could explain the low level of 25(OH)D observed in obese~     subjects, the more classical evoked being based on sequestration and/or dilution of VD in~     adipose tissue (AT), the main VD storage site. However, this mechanism has never been~     demonstrated. In order to confirm this hypothesis, the concentration of VD and its~     metabolites in adipose tissue need to be quantified.~      The objective of this study is to determine the concentration of VD and its metabolites in~     adipose tissue as well as adipose tissue mass quantification and distribution (visceral or~     subcutaneous) to highlight putative difference of VD and its metabolites quantities between~     obese and non-obese patients. A quantification of VD metabolism, inflammation and lipid~     metabolism gene expression will be realized on biopsies. Correlations between gene expression~     and quantity of VD in tissue will be carrying out.~   "
42649|NCT03008512|"~     This study evaluate activity and safety profile of weekly Genexol-PM in patients with~     advanced hepatocellular carcinoma for whom sorafenib treatment failed. Patients will receive~     Genexol-PM on days 1, 8, and 15 every 4 weeks.~   "
42650|NCT03008499|"~     The aim of this study is the safety and efficacy of high-activity natural killer~     immunotherapy to small metastases of colorectal cancer.~   "
42651|NCT03008486|"~     The purpose of this study is to assess the effects on upper limb spasticity of soft splints~     worn during three weeks three hours a day by patients with stroke or disorders of~     consciousness.~   "
42652|NCT03008473|"~     Video laryngoscope and chest CT iminge for the placement of the Uniblocker~   "
42653|NCT03008460|"~     The purpose of the protocol is to demonstrate that Eziclen®/Izinova®, an osmotic~     sulphate-based laxative preparation given on the day before colonoscopy has non-inferior~     efficacy to Klean-Prep® (polyethylene glycol (PEG)-electrolytes) on colon cleansing in~     adolescents aged 12 to 17 years (inclusive) with a body weight >40 kg, scheduled to undergo a~     colonoscopy for a routinely accepted diagnostic indication.~   "
42654|NCT03008447|"~     E2006-A001-108 is a 4-period crossover study designed to demonstrate that the mean change~     from baseline in postural stability (worsening) when participants are awakened at~     approximately 4 hours postdose is significantly less after lemborexant than after zolpidem~     tartrate extended release following a single-dose administration at bedtime.~   "
42655|NCT03008434|"~     This long-term goal of this project was to advance best practices in occupational therapy in~     conjunction with yoga. To address the long-term goal, this research team developed a pilot~     yoga intervention. The intervention was designed to focus on balance, balance confidence,~     body responsiveness, pain, physical ability and quality of life. Assessments were then chosen~     to address these areas pre and post yoga intervention. A manual and protocol were developed~     for the intervention and then the intervention was implemented with a group of individuals~     with chronic traumatic brain injury.~   "
42656|NCT03008421|"~     In the present study, the investigators aim to evaluate the potential of oral probiotics,~     containing Lactobacillus strains, to eradicate and reduce the vaginal colonization with group~     B Streptococcus (GBS) during pregnancy. This could help to prevent neonatal morbidity and~     mortality by reducing the risk for neonatal sepsis, pneumonia, and meningitis, known as~     early-onset or late-onset GBS infection.~   "
42657|NCT03008408|"~     The goal of this clinical research study is to learn if the combination of everolimus,~     letrozole, and ribociclib can help to control recurrent (has returned after treatment) or~     progressive endometrial cancer. The safety of this drug combination will also be studied.~   "
42658|NCT03008395|"~     Outcomes in type 2 diabetes are largely achieved by self-management efforts by individuals~     living with diabetes. Diabetes self-management is typically provided using the principles of~     adult education. Current evidence suggests that standard educational interventions are~     suboptimal. This study evaluates a novel approach to diabetes self-management using dialogue~     tools based on empowerment and motivational communication methods. The approach evaluated in~     this study is called EMMA: empowerment, motivation and medical adherence. Participants will~     be randomized to EMMA and treatment as usual, treated for a period of 4 months and evaluated~     over a period of 12 months.~   "
42659|NCT03008382|"~     Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) afflicts 3 to 8 million women in the US.~     Symptoms of IC/BPS reduce quality of life, suppressing both social well-being and physical~     function. The chronic pain, voiding dysfunction, sleep deprivation and associated co-morbid~     conditions interfere with relationships and employment with significant direct (doctor~     visits, medication, surgery) and indirect (loss of productivity) economic impact, currently~     exceeding $100 million per year.This proposal aims to move the science of chronic pelvic pain~     (CPP) from simple associations towards an investigation of cause and effect relationships.~     The investigators will determine whether the striking changes in autonomic nervous system~     responsiveness (ANS-R) contribute meaningfully to the pathogenesis of IC/BPS.~   "
42660|NCT03008369|"~     This phase II trial studies how well lenvatinib works in treating patients with~     pheochromocytoma or paraganglioma that has spread to other places in the body or cannot be~     removed by surgery. Lenvatinib may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth.~   "
42661|NCT03008356|"~     supplementation with L-carnitine that is available both as an FDA-approved therapy for~     primary carnitine deficiency, as well as widely available as an over-the-counter ergogenic~     aid will improve wellbeing and function measured by questionnaires in patient with chronic~     obstructive pulmonary disease (COPD).~      based on our review of literature that addition of health coaching (HC) to L-carnitine will~     yield greater gains.~   "
42662|NCT03008343|"~     The aim of this study is the safety and efficacy of irreversible electroporation (IRE) plus~     natural killer (NK) immunotherapy to recurrent liver cancer.~   "
42663|NCT03008330|"~     The aim of this study is the safety and efficacy of high-activity natural killer~     immunotherapy to small metastases of tongue cancer.~   "
42666|NCT03008291|"~     Participants in this study will either have heart failure (HF) and are scheduled to undergo~     cardiac resynchronization therapy pacemaker (CRT-P) or cardiac resynchronization therapy~     defibrillator (CRT-D) implantation, or have atrioventricular (AV) block and are scheduled to~     undergo dual chamber pacemaker implantation. In this study additional heart rhythm~     measurements will be collected during the implant procedure to better understand how His~     bundle and/or parahisian pacing (HISP) effects electrical conduction in the hearts of~     patients with HF or AV block.~      The hypothesis is that His bundle or parahisian pacing (HISP) may normalize atrioventricular~     (AV) conduction with a narrow combination of the Q wave, R wave and S wave (QRS complex) in~     functional bundle branch block or conduction delay in patients with heart failure (HF).~   "
42667|NCT03008278|"~     This pilot phase I/II trial studies the side effects and best dose of olaparib when given~     together with ramucirumab and how well they work in treating patients with gastric or~     gastroesophageal junction cancer that has spread to other places in the body, has come back,~     or cannot be removed by surgery. Olaparib may stop the growth of tumor cells by blocking some~     of the enzymes needed for cell growth. Monoclonal antibodies, such as ramucirumab, may~     interfere with the ability of tumor cells to grow and spread. Giving olaparib and ramucirumab~     may work better in treating patients with gastric or gastroesophageal junction cancer.~   "
42668|NCT03008265|"~     Nationwide cohort study on short- and long-term mortality of patients with and without~     postoperative fascial dehiscence.~      The cohort will be comprised of patient undergoing open colonic resection for colonic cancer~     registered in the Danish Colorectal Cancer Group Database. The exposure is fascial dehiscence~     and the outcome of interest 30-day, 3- and 5-year mortality.~   "
42669|NCT03008252|"~     In the last few years a new clinical entity has emerged which includes patients who consider~     themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though~     they do not have celiac disease (CD) or wheat allergy. This clinical condition has been named~     non-celiac gluten sensitivity (NCGS), although in a recent article, the researchers suggested~     the term non-celiac wheat sensitivity (NCWS), because it is not known to date what~     component of wheat actually causes the symptoms. The clinical picture of NCWS is~     characterized by combined gastrointestinal (bloating, abdominal pain, diarrhea and/or~     constipation, nausea, epigastric pain, gastroesophageal reflux, aphthous stomatitis) and~     extra-intestinal or systemic manifestations (headache, depression, anxiety, 'foggy mind,'~     tiredness, dermatitis or skin rash, fibromyalgia-like joint/muscle pain, leg or arm numbness,~     and anemia). Lactose intolerance and cow's milk protein allergy (CMPA) are two medical~     conditions with a very high prevalence in the general population, and there is a large~     overlap between NCWS symptoms and lactose intolerance and CMPA symptoms. Therefore, the aims~     of the present study are to investigate 1) the prevalence of positive lactose breath test and~     DBPC cow's milk protein challenge in NCWS patients with self-reported gastrointestinal~     symptoms related to milk and/or milk derivates ingestion, 2) the clinical, serological, and~     histological characteristics of NCWS patients with lactose intolerance and CMPA in comparison~     to NCWS patients without lactose intolerance and CMPA.~   "
42670|NCT03008239|"~     This study evaluates the performance and safety of the fluorescence based fibre optic glucose~     sensor for home usage.24 subjects will take part in the study, including 4 pre-diabetic~     subjects, 8 Type I diabetic patients, 8 Type II diabetic patients and 4 diabetic patients who~     require continuous ambulatory peritoneal dialysis (CAPD). Type 1, Type 2 and prediabetic~     subjects will wear one FiberSense sensor, randomly allocated to either the upper arm (50%) or~     abdomen (50%) for 28 days. In addition, these subjects will wear a Dexcom sensor on the other~     side of the abdomen for 7 days in one of the four study weeks. In all 4 CAPD subjects, one~     FiberSense sensor will be placed in the upper arm for 28 days. No additional comparator~     sensor will be placed in CAPD subjects.~   "
42671|NCT03008226|"~     The purpose of this observational study is to investigate the efficacy of 9 mm intrabronchial~     valve treatment in patients with heterogeneous emphysema and to gain further insights and~     experience on the treatment with this valve size.~   "
42672|NCT03008213|"~     Prevention and control of Chemotherapy-Induced Nausea and Vomiting (CINV) are most important~     in treatment of cancer patients. CINV is one of the most distressing severe side effects of~     cancer treatment and can have a significant impact on a patient's quality of life. The~     chemotherapy agents that cause the worst degree of nausea and vomiting are categorized into~     two groups: moderately emetogenic chemotherapy (MEC) and highly emetogenic chemotherapy~     (HEC). Nausea and vomiting that occurs within the first day of the administration of~     chemotherapy agents is considered acute CINV, while nausea and vomiting following 24 hours of~     the administration of chemotherapy agents is considered delayed CINV. Refractory CINV occurs~     when patients develop CINV during subsequent cycles of chemotherapy when drugs preventing~     vomiting and nausea (antiemetic prophylaxis) has not been successful in controlling CINV in~     earlier cycles. The purpose of this study is to assess the efficacy of Akynzeo in the~     treatment of refractory CINV~   "
42673|NCT03008200|"~     Fetal PATET ratio evaluation to predict neonatal RDS~   "
42674|NCT03008187|"~     Phase I/II, open-label, multi-center, dose escalation study to estimate the MTD (or MAD) of~     SEL24 in patients with AML.~      At the end of Part 1 an RD of SEL24 will be selected for further evaluation in Part 2.~      In Part 2 the safety and anti-leukemic activity of SEL24 will be further assessed in patients~     who are unfit to receive intensive chemotherapy.~   "
42686|NCT03008031|"~     The optimal dose of iodine based contrast agents used in contrast-enhanced spectral~     mammography (CESM) is unknown. If CESM, performed with lower dose of iodine based contrast~     agent, visualizes a tumor comparable to CESM with regular dose of contrast agent, patients~     can receive less contrast agent for CESM in future and thereby risking less side effects of~     the contrast agent.~      In order to study whether CESM remains unchanged at smaller amounts of contrast~     administration, a second CESM exam will be performed within one week of the first with a an~     alternative amount of contrast, it being either 80%, 60% or 40% of the original contrast~     dose. The settings of the CESM unit will remain unchanged.~   "
42696|NCT03007901|"~     To work with community partners to pilot test a mindfulness-based behavioral program aimed~     at: (a) enhancement of health and well-being, and (b) reduction in carbon footprint; (2) to~     develop, implement, and refine methods for assessing carbon footprint at the individual~     level; and (3) to work with pilot participants and community partners to carry out a~     proof-of-concept research study to assess impact on health, well-being, and carbon footprint.~   "
42675|NCT03008174|"~     Patients with tracheostomy who are on and off of mechanical ventilation initially lose the~     ability to speak, and the use of one-way speaking valves (OWSV) is one method of restoring~     speech in these patients. Patients with tracheostomy who experience loss of speech report~     frustration and feelings of confinement from their communication impairment, therefore~     investigators would like to restore speech in these patients as soon as it is safe to do so.~     However, there is currently little known in the literature about the timing of the use of~     OWSV in patients with tracheostomy. Therefore, the investigators propose a pre-test post-test~     clinical trial pilot study to investigate the safety of early use of OWSV in patients~     undergoing a percutaneous tracheostomy. Study aims are to identify patients who would benefit~     from the early use of OWSV and to determine the effects of early use of OWSV on speech and~     clinical outcomes. To achieve these aims, patients who undergo percutaneous tracheostomy will~     be screened, and patients meeting screening criteria will be randomized into intervention and~     control groups. The intervention group will receive early speech-language pathology (SLP)~     evaluation and OWSV trial at 12-24 hours following tracheostomy procedure, and the control~     group will receive standard SLP evaluation and OWSV trial at 48-60 hours following~     tracheostomy procedure. Intervention and control groups will been compared on speech and~     clinical outcomes measures from pre-test at 12-24 hours following tracheostomy and post-test~     at 48-60 hours following tracheostomy and characteristics of patients who successfully~     tolerate early OWSV use will be identified.~   "
42676|NCT03008161|"~     The purpose of the study is to evaluate the safety and tolerability of multiple doses of~     NPT088 in patients with mild to moderate probable Alzheimer's Disease. The study will also~     evaluate the pharmacokinetics, immunogenicity and exploratory pharmacodynamic characteristics~     of multiple doses of NPT088.~   "
42677|NCT03008148|"~     This is a multi-center, phase II/III, open-label, randomized, parallel and standard~     chemoradiation-controlled study where eligible subjects will be randomized at 1:1 ratio to~     receive control treatment or study treatment. The primary objective of this trial is to~     evaluate the effect of add-on JP001 to standard chemoradiation in increasing overall survival~     (OS) on newly diagnosed glioblastoma (GBM) patients.~   "
42678|NCT03008135|"~     This study evaluates the reliability of the French version of the elderly mobility scale~     and its correlation with the frailty elderly scale ~   "
42679|NCT03008122|"~     This study is randomized, double-blinded, placebo-controlled, Phase 1, dose de-escalation~     study to evaluate the safety, reactogenicity, and immunogenicity of Alum Adjuvanted Zika~     Virus Purified Inactivated Vaccine (ZPIV) administered to healthy male and non-pregnant~     female adult subjects. This study will enroll 90 healthy male and non-pregnant female~     subjects between the ages of 21 and 49 and will be conducted at Ponce Medical School~     Foundation, Inc.-CAIMED in Ponce, Puerto Rico. The duration of each subject's participation~     is approximately 26 months from recruitment through the last study visit. The entire study is~     expected to take approximately 49 months to complete. Two dose levels will be evaluated. Each~     subject will receive either placebo or 5 mcg (Group 1) or 2.5 mcg (Group 2) of ZPIV~     administered by intramuscular (IM) injection on Days 1 and 29. Solicited local and systemic~     reactogenicity data will be collected from all subjects through Day 8 after each vaccination.~     All subjects will be monitored for occurrence of unsolicited adverse events until 28 days~     after the second vaccination. The study will consist of a screening period of up to 28 days,~     a vaccination period in which subjects will receive a prime dose of vaccine on Day 1 followed~     by a boost on Day 29, and a follow-up period of 24 months post boost vaccination. Primary~     objectives are: 1) Assess the safety and reactogenicity of a homologous prime boost regimen~     of ZPIV given at two different dose levels. 2) Compare the safety and reactogenicity of ZPIV~     after each vaccination, between dosage groups, and by pre-vaccination flavivirus immune~     status.~   "
42680|NCT03008109|"~     EGFR Tyrosine-Kinase Inhibitor monotherapy is widely used in treatment of patients with EGFR~     mutation-positive Non-small cell lung cancer(NSCLC), In despite of the benefit of PFS~     （progression-free survival） , the OS （ overall survival） is limited extended. This study is~     aim to observe the safety and efficacy of the combination of an anti-angiogenic drug~     recombinant human-endostatin with EGFR TKI ,to find out a new strategy which may further~     extend the PFS and OS with a tolerated toxicity.~   "
42681|NCT03008096|"~     In LVAD (Left-Ventricular Assist Device) patients, evidence is lacking regarding the safety~     and efficacy of Laparoscopic Sleeve Gastrectomy (LSG) as a means to reach a Body Mass Index~     (BMI) within listing criteria for heart transplantation. To our knowledge, this is the first~     prospective study to evaluate laparoscopic sleeve gastrectomy in LVAD patients as~     bridge-to-candidacy for heart transplantation.~   "
42682|NCT03008083|"~     This study is a prospective,multi-center, open-label, randomized controlled clinical~     trial,aims to assess the clinical noninferiority of 3 months (short-term) vs 12 months~     (long-term) of Dual Anti-Platelet Therapy (DAPT) in patients undergoing percutaneous coronary~     intervention implanted sirolimus target- eluting stent with abluminal grooves containing a~     biodegradable polymer (Firehawk™ stent). All participants met the inclusion criteria begin~     taking aspirin and open-label thienopyridine therapy before index procedure, and will be 1:1~     randomized to 3 months or 12 month of DAPT at index procedure.~   "
42683|NCT03008070|"~     Non-alcoholic steatohepatitis, abbreviated as NASH, is a chronic liver disease that may~     progress to cirrhosis. The disease is mostly associated with obesity and type 2 diabetes~     mellitus, or insulin resistance and is very common. However, Treatment of NASH is a~     significant unmet clinical need.~      IVA337 is a next generation pan-PPAR (peroxisome proliferator-activated receptors) agonist~     addressing the pathophysiology of NASH : metabolic, inflammatory and fibrotic.~      The purpose of this research is to evaluate the efficacy and the safety of two doses of~     IVA337 (800mg, 1200 mg) per day for 24 weeks versus placebo in adult NASH patients with liver~     steatosis and moderate to severe necroinflammation without cirrhosis.~   "
42684|NCT03008057|"~     The aim of this study is to determine the effects of vitamin D or placebo for 3 months on the~     gene expression of glyoxalase enzyme, RAGE, and YKL40 in the peripheral blood mononuclear~     cell (PBMC) and serum levels of YKL40,AGEs, TNF-α, PAI-1, IL-6, and HbA1c of diabetes type 2~     patients.~   "
42685|NCT03008044|"~     This is a single center prospective study. The purpose of this study is to assess the~     performance of FiberSense system across the glucose measurement ranges (from hypoglycemia to~     hyperglycemia) as compared with a gold standard reference laboratory method (YSI glucose) in~     healthy volunteers.~   "
42687|NCT03008018|"~     The aim of the study is to evaluate the safety/tolerability, pharmacokinetic, and~     pharmaco-dynamic effects of KA2507 and establish the maximum tolerated dose (MTD). Patients~     with PD-L1 expressing solid tumors which have relapsed or are refractory to prior treatment~     will be eligible to participate in this study.~      Following completion of the multiple ascending dose study, the protocol may be amended to~     include expansion cohorts in patients with melanoma and/or other solid tumors.~   "
42688|NCT03008005|"~     The goal of this study is to look at how a type of drug called cannabinoids are related to~     the processing of fear signals, the experience of emotions and fear, and the pattern of~     activity in the brain that is involved in these processes and how this relates to the~     development of post-traumatic stress disorder (PTSD). PTSD is an anxiety disorder that occurs~     after experiencing a traumatic event(s) and is characterized by unwanted memories of the~     trauma(s) through flashbacks or nightmares, avoidance of situations that remind the person of~     the event, difficulty experiencing emotions, loss of interest in activities the person used~     to enjoy, and increased arousal, such as difficulty falling asleep or staying asleep, anger~     and hypervigilance. The information gained from this study could lead to the development of~     new treatments for persons who suffer from anxiety or fear-based disorders.~   "
42689|NCT03007992|"~     The purpose of the trial is to investigate the efficacy of metronomic treatment with daily~     oral vinorelbine in terms of clinical benefit rate based on local radiological assessment in~     patients with advanced/metastatic HR+/HER2- breast cancer resistant to endocrine therapy.~   "
42690|NCT03007979|"~     The investigators propose to conduct a study to test an alternative dosing schedule of~     palbociclib. With the current three-week on and one week off schedule, a significant number~     of patients develop grade 3 or higher degree of neutropenia and require dose reduction and~     sometimes discontinuation. This potentially compromises the efficacy of the drug. In~     addition, as the half-life of palbociclib is 27 hours, 1 week break with the standard 3 weeks~     on and 1 week off dosing schedule could potentially lead to recovery of Rb phosphorylation~     during the off week. Hence, the investigators propose a 5 days on and 2 days off schedule~     each week without any weeks off drug. Although the cumulative doses each 28-day cycle is~     roughly the same with this schedule compared to conventional dosing, the bone marrow is not~     exposed to the drug continuously for 21 days and rather gets frequent breaks from therapy.~     The investigators hypothesize that the 5 days on and 2 days off schedule is more tolerable~     with less frequent high grade neutropenia and dose interruption/reduction. In addition, this~     schedule also provides for a more continuous drug delivery to the patient since there is not~     a week's break in therapy, which could ultimately prove to be more efficacious.~   "
42691|NCT03007966|"~     Open inguinal herniorrhaphy is a common outpatient surgical procedure. Post-operative pain~     can be a significant hindrance to discharge from the post anesthesia care unit. Pain can be~     treated with opioid therapy, but the literature supports that these agents are known to~     create or exacerbate adverse effects and complications, including post-operative nausea and~     vomiting, hypoxia, and urinary retention. In contrast, analgesia provided by regional~     anesthesia results in a decreased risk of the aforementioned complications.1 Because of this,~     various regional anesthetic techniques have been developed to provide analgesia following~     open herniorrhaphy. One technique is a combined ilioinguinal and iliohypogastric nerve block~     (IINB), which has been shown to decrease the initial pain after inguinal herniorrhaphy.2 The~     quadratus lumborum block (QLB) is a newer regional anesthetic technique that we think could~     be as effective as IINB at providing pain control following open herniorrhaphy. Additionally,~     because local anesthetic injected during a QLB has the potential to spread cranially into the~     thoracic paravertebral space following its lumbar deposition it could lead to alleviation of~     both somatic and visceral pain.3 This might therefore improve the quality and or duration of~     analgesia as compared to the IINB. To the best of the author's knowledge there has been no~     investigation comparing the efficacy, with regards to post-operative pain management, between~     IINB and QLB.~   "
42692|NCT03007953|"~     The focus of the study is to test a nurse-led telephone-based palliative care intervention on~     improving the delivery of care for patients with newly diagnosed lung cancer. The study is a~     three site randomized control trial to determine the efficacy of the intervention on~     improving patients' quality of life, symptom burden, and satisfaction of care. Additionally,~     the study will test an innovative care delivery model to improve patients' access to~     palliative care. The investigators will also determine the effect of the intervention on~     patient activation to discuss treatment preferences with their clinician and on clinician~     knowledge of patients' goals of care.~   "
42693|NCT03007940|"~     This is an implementation research study designed to evaluate a defined strategy, NIATx, for~     its effectiveness in installing and sustaining evidence-based integrated services for persons~     with co-occurring substance use and mental health disorders. This study is a cluster~     randomized wait-list control group design, in which a cohort of 25 addiction treatment~     agencies receives the active NIATx approach during an index 12 month period. The second~     (wait-list) cohort of 25 addiction treatment agencies activates NIATx strategies during a~     second index 12 month period. The primary subjects of the research are the treatment~     agencies themselves. The study specific aims are:~        1. Relative to wait-list, to determine if NIATx strategies improve implementation outcomes~          (integrated service fidelity and receipt of more integrated services)~        2. Relative to wait-list, to determine if NIATx strategies improve patient care outcomes~          (psychiatric, alcohol and drug problem severity)~        3. Across entire sample, to evaluate variation in the extent of and fidelity to NIATx~          strategies~      NIATx implementation strategies consist of learning sessions, individualized coaching and~     peer to peer sharing.~   "
42694|NCT03007927|"~     To evaluate the impact on the postoperative pain of the dexamethasone addition to the usual~     treatment with bupivacaine in the local infiltration of the surgical area in Inguinal Hernia~     Repair Mesh~   "
42695|NCT03007914|"~     The aim of this study is to compare the effectiveness of the treatments in two cohort for~     COPD patients: one, traditional Chinese medicine (TCM) cohort, which have been evaluated and~     have certain effect; the other, conventional medicine treatments cohort, based on 2015 Global~     Initiative for Chronic Obstructive Lung Disease (GOLD).~   "
43864|NCT02992665|"~     The purpose of this study is to determine the impact of the use of calcium ionophore on the~     ICSI outcomes in couples with severe male factor infertility. Investigators conduct a~     randomized controlled trial on the sibling oocyte to justify the use of calcium ionophore in~     these cases.~   "
42697|NCT03007888|"~     Primary Objective:~      To compare the pharmacokinetics (PK) of single and multiple doses of IPX203 with Immediate~     release carbidopa-levodopa (IR CD-LD) in subjects with advanced Parkinson's disease (PD).~      Secondary Objectives:~      To compare the pharmacodynamics of single and multiple doses of IPX203 with IR CD-LD.~      To compare the efficacy of IPX203 with IR CD-LD following multiple doses.~      To evaluate the safety of IPX203.~   "
42698|NCT03007875|"~     The aim of this study is the safety and efficacy of high-activity natural killer~     immunotherapy to small metastases of non-small cell lung cancer.~   "
42699|NCT03007862|"~     Early Aspiration Pneumonia is a frequent and dreadful complication in survivors of cardiac~     arrest. Therapeutic Hypothermia widely used in Intensive Care Unit for its benefice on post~     cardiac arrest syndrome may otherwise hide signs of early pneumonia that may occur without~     use of a reliable screening biological marker. The goal is to assess the diagnostic accuracy~     of bronchial alpha amylase measure to predict a risk of early aspiration pneumonia in~     patients successfully resuscitated after out-of-hospital cardiac arrest.~      In this prospective non interventional study we included patients resuscitated after cardiac~     arrest and treated with Targeted Temperature Management (TTM). A distal bronchoalveolar~     lavage using specific display (Combi-Cath) was executed immediately after admission for each~     patient with both biochemic and bacteriological analysis including dosage of bronchial~     salivary alpha amylase. Urea was used as a marker of dilution in the measure of bronchial and~     plasmatic alpha amylase. Aspiration pneumonia diagnosis was established with clinical and~     biological criteria. On this basis we intended to determine a threshold measure of alpha~     amylase predicting occurrence of aspiration pneumonia and allowing a guidance in~     antibiotherapy prescription. Sensibility and Specificity of this technique were determined.~   "
42700|NCT03007849|"~     Patients with sickle cell disease often develop painful crisis without any obvious reasons.~     Some patients are more likely to develop this complication than others. It is now clear that~     painful crisis only occurs when sickled red blood cells stick to white blood cells that have~     been activated, usually by inflammation or infections. A recent study in mice with sickle~     cell disease showed that the use of long term antibiotics could reduce the number of~     activated white blood cells and reduce death of the mice during sickle cell crisis.~      The investigators believe that sickle cell patients who develop frequent painful crisis may~     have a different pattern of bacteria in their intestine when compared to those whose painful~     crisis occurs infrequently. In this study, the investigators propose to study sickle cell~     subject's blood to determine how many activated white blood cells he/she have. The~     investigators will also examine his/her stool to compare the bacteria in his/her stool to~     those other sickle cell patients. The investigators will then investigate whether or not the~     results from the blood and stool tests correlate with how frequently the patient develops~     painful crisis.~      The investigators will examine the patients' medical records to find out how many times they~     have been admitted to the hospital for sickle cell crisis in the last 12 months. The~     investigators will also obtain information on the following: their age, their sex, whether~     they are taking hydroxyurea or Penicillin, when they last had a transfusion or exchange~     transfusion therapy and painful crisis needing hospital admission, whether they have received~     any antibiotics (other than Penicillin) in the last 4 weeks, and whether they are~     experiencing a painful crisis at the time that they enter the study. The investigators will~     obtain, from their previous laboratory results, their levels of hemoglobin F and markers of~     inflammation. The investigators will check their hemoglobin F level if they have not already~     had this tested.~      The investigators expect to enroll 50 subjects into this study at Rhode Island~     Hospital/Hasbro Children's Hospital.~   "
42701|NCT03007836|"~     The aim of this study is the safety and efficacy of high-activity natural killer~     immunotherapy to small metastases of nasopharyngeal cancer.~   "
42702|NCT03007823|"~     The aim of this study is the safety and efficacy of high-activity natural killer~     immunotherapy to small metastases of melanoma.~   "
42703|NCT03007810|"~     Hemay005 is a novel phosphodiesterase type 4(PDE4) inhibitor being developed for the~     treatment of psoriasis. This study is the first administration of Hemay005 in humans to~     establish the initial safety, tolerability, and pharmacokinetic profile following single~     doses of Hemay005. A total of approximately 44 subjects will be randomized into 6~     cohorts(10mg, 20mg, 40mg, 80mg, 120mg, 180mg), approximately 8 healthy subjects will be~     enrolled (6 active and 2 placebo) at each dose cohort by sentinel method(1 active and 1~     placebo,5 active and 1 placebo), with the exception of 10mg (4 active) cohort. This study~     includes an 28-day Screening Period, a 1-day Treatment Period, and an End of Study Visit~     occurring approximately 11days (±3 days) after study drug administration.~   "
42704|NCT03007797|"~     Introduction:~      In 2010, the vaccination recommendations for pregnant women against seasonal influenza were~     published by the German Standing Committee on Vaccination (STIKO). This work deals with the~     immunization coverage and the influencing factors.~      Method:~      A cross-sectional study was realized at two Level 1 perinatal centers in two German federal~     states during the influenza saisons 2012/2013 and 2013/2014. Pregnant women were interviewed~     by using a standardized and pre-tested questionnaire covering their knowledge about the~     influenza vaccination and other factors influencing the vaccination decision. Furthermore,~     data from the vaccination card and the pregnancy record booklet have been evaluated.~   "
42705|NCT03007784|"~     Limited treatments are available to improve consciousness in severely brain injured patients.~     Transcranial Direct Current stimulation (tDCS) is one of the few therapeutics that showed~     evidence of efficacy to increase level of consciousness and functional communication in some~     minimally conscious state (MCS) patients, and in some vegetative state (VS) patients. However~     the optimal intensity of electrical current stimulation remains unknown.~      This study will test the effects of two intensities of tDCS stimulation (either 0.2mA or 2mA)~     applied on left dorso-lateral prefrontal cortex on both behavior, - assessed by the Coma~     Recovery Scale-Revised (CRS-R) scores -, as well as quantified EEG recorded during resting~     state (using algorithms previously designed and published by the investigators) and~     event-related potentials (using auditory paradigms we previously published) in severely brain~     damaged patients with disorders of consciousness (MCS, VS, and conscious but cognitively~     disabled patients) of various etiologies.~   "
42706|NCT03007771|"~     This study will help to elucidate the treatment sites in the extremities and pelvis for which~     MR-guided HIFU heating is feasible, which has the potential to be beneficial for patients~     with conditions at those sites (soft tissue sarcoma, cervical cancer, etc.). The~     investigators anticipate that successful completion of this study will lead to clinical~     trials in those feasible sites of interest to determine the safety and efficacy of~     administering therapeutic levels of heat for hyperthermia or other applications.~   "
42707|NCT03007758|"~     The purpose of this study is to determine how the robotic retromuscular hernia repair~     compares to the open retromuscular hernia repair for large hernia defects in patients at~     higher risk of wound complications.~   "
42829|NCT03006159|"~     This is a randomized, placebo-controlled, multiple dose escalation study to investigate the~     safety, tolerability, pharmacokinetics and pharmacodynamics of SHR0534. The study will be~     conducted with dose of 5 mg, 10mg and 25 mg. Chinese Type 2 Diabetic patients will be~     randomized in each cohort to receive the study drug or placebo.~   "
42708|NCT03007745|"~     Although obstructive sleep apnea, a breathing disorder during sleep, is prevalent and~     recognized as a major public health concern, most Veterans with this disorder are undiagnosed~     and therefore untreated. Access to sleep laboratories for testing is limited particularly for~     those Veterans living in rural areas and Veterans with disabilities that prevent travel to a~     sleep center. The goal of this study is to compare a web-based telehealth management strategy~     to in-person management. The telehealth pathway will enable Veterans to be diagnosed and~     treated without visiting a sleep center. The investigators believe that telehealth management~     will increase Veterans' access to this specialized care at a cost that is less than in-person~     delivery but with similar improvements in daytime function.~   "
42709|NCT03007732|"~     This is a non-comparative open-label multicenter Phase 2 clinical trial combining~     stereotactic body radiation therapy (SBRT) and pembrolizumab with or without intratumoral~     SD-101 in patients with newly diagnosed hormone-naive oligometastatic prostate cancer.~   "
42710|NCT03007719|"~     This phase II trial studies how well fluorine F 18 Ara-G positron emission tomography~     (PET)/magnetic resonance (MR) imaging works in measuring clinical response to atezolizumab or~     patients with cancer receiving standard of care Anti-PD-1/L1. Diagnostic procedures, such as~     fluorine F 18 Ara-G PET/MR imaging, may help measure a patient's response to standard of care~     atezolizumab or Anti-PD-1/L1 treatment.~   "
42711|NCT03007706|"~     This study aims to determine the effectiveness of skin cleansing and prophylactic antibiotics~     given to women undergoing a cesarean section for reducing the incidence of postpartum~     infectious morbidity and to assess potential maternal adverse effects and any impact on the~     infant.~   "
42712|NCT03007693|"~     The purpose of this study is to investigate the safety and tolerability of JNJ-61393215 after~     multiple consecutive dose administrations and to characterize the pharmacokinetics (PK) of~     JNJ-61393215 in plasma after multiple consecutive dose administrations.~   "
42713|NCT03007680|"~     The purpose of this study is to determine whether core muscle activation is effective in the~     increase of quality of cardiopulmonary resuscitation.~   "
42714|NCT03007667|"~     To investigate the changes in the anatomical location of ureters after colorectal surgery.~   "
42715|NCT03007654|"~     The purpose of this study is to evaluate the efficacy and safety of Mediclore®, as an~     antiadhesive barrier, which is made of Poloxamer, Gelatin and Chitosan.~   "
42716|NCT03007641|"~     The purpose of this study is to enhance the care of older metastatic breast cancer (MBC)~     patients by increasing awareness among oncology providers as to the unique aspects of care~     required for older patients. The goal of the study is to educate providers on the utility of~     geriatric assessment in guiding therapy of older metastatic breast cancer patients. The~     investigators will also assess the feasibility and benefit of incorporating geriatric~     self-assessments into clinical practice. The study will include three phases.~   "
42717|NCT03007628|"~     This trial attempts to evaluate the treatment efficacy of magnetic seizure therapy (MST) and~     its safety among schizophrenia patients. Half of the participants will be randomized to MST~     group, while the other half will be randomized to receive electroconvulsive therapy (ECT).~   "
42718|NCT03007615|"~     To evaluate the safety of an investigational product through the verification of signs of~     irritability and sensitization of the genital mucosa, as well as the instrumental~     moisturizing efficacy by TEWL and barrier integrity analysis, in addition to the efficacy~     perceived by the volunteers.~   "
42719|NCT03007602|"~     Hematologic malignancy is a tumor of myeloid or lymphatic cells that affects lymph nodes with~     the involvement of blood, bone marrow or other organs.There are various treatment options for~     hematological malignancies ranging from follow-up to single or multiple agent chemotherapy,~     radiotherapy, immunotherapy and autologous or allogeneic hematopoietic stem cell~     transplantations (HSCT). The general recommendation for patients is to relax and avoid~     intense exercise, regardless of the devastating consequences of neglecting physical exercise.~     Patients also go to relaxation by reducing their activity to avoid fatigue, which leads to~     loss of muscle strength and endurance. As a consequence of all, fatigue, vomiting, weight~     loss, anemia, depression, decreased aerobic capacity, muscle weakness, decreased physical~     function and poor quality of life are observed in HSCT recipients. It has been shown that~     physical exercises improve oxygen consumption, depression and fatigue, cardiorespiratory~     fitness, muscle strength and physical well-being in patients with hematologic malignancies~     who are at stages of various treatments. In literature, effects of upper extremity aerobic~     exercise training have been investigated in patients with spinal cord injury, neuromuscular~     diseases, claudication, hypertension, multiple sclerosis, heart failure, paraplegic patients~     and healthy individuals. Results of these studies has shown that upper extremity aerobic~     exercise training improves walking distance, increases oxygen pulse, muscle strength and~     endurance of upper extremity. No study was observed to investigate the effects of upper~     extremity aerobic exercise training on exercise capacity and quality of life in HSCT~     recipients, as we know. For this reason, our aim is to investigate the effects of upper~     extremity aerobic exercise training on exercise capacity and quality of life in HSCT~     recipients.~   "
42720|NCT03007589|"~     The purpose of this study is to assess how sunscreens and sun protection fabrics perform in~     natural sunlight compared to their labeled claims, indoor testing methods (existing or~     modified) and instructions.~   "
42721|NCT03007576|"~     Osteoarthritis (OA) is a common and incurable disease for the elderly in Taiwan, so it is an~     important mission to develop a new treatment for OA. Recently, cellular therapy is a new and~     popular medical treatment around the world, one of them is Mesenchymal Stromal Cells~     (MSCs). MSCs are found in many tissues of human body and play an important role for~     repairing, regeneration, anti-inflammatory and chondrogenesis. So, MSC product, RegStem, for~     osteoarthritis treatment becomes a developing target for new generation drugs.~      This study is to isolate and expand MSCs(RegStem) from infrapatellar fat pad of subject. When~     the number of MSCs expands to 1×10^8, cell will be cryopreserved in the liquid nitrogen tank~     until all release tests passed. On the distribution day, cell will be thawed and injected~     into joint cavity of patient (5×10^7). Subjects will be monitored after MSC product infusion~     of seven days, one month, six months and one year. The monitoring items include the changes~     of knee (by appearance, X-ray and MRI of knee) and pain improvement (by questionnaire).~   "
42734|NCT03007407|"~     This study is being done to look at the safety and response to the combination of two~     investigational drugs, tremelimumab and durvalumab, when given after radiation therapy for~     patients with microsatellite stable (MSS) metastatic colorectal cancer. Tremelimumab and~     durvalumab recognize specific proteins on the surface of cancer cells and trigger the immune~     system to destroy the cancer cells.~      In order to learn more about certain characteristics of colorectal cancer tumors, this study~     includes special research tests using samples from diagnostic tumors, fresh tumor samples~     from an area where the cancer has spread, and blood samples.~   "
42735|NCT03007394|"~     The objective of this study is to evaluate the efficacy and safety of lorcaserin in the~     treatment of cocaine use disorder.~   "
42722|NCT03007563|"~     Neonatal jaundice is a common and most often harmless condition. However, when unrecognized~     it can be fatal or cause serious brain injury. Three quarters of these deaths are estimated~     to occur in the poorest regions of the world. The treatment of jaundice, phototherapy, is in~     most cases easy, low-cost and harmless. The crucial point in reducing the burden of disease~     is therefore to identify then children at risk. This results in the need for low-cost,~     reliable and easy-to-use diagnostic tools that can identify newborns with jaundice.~      Based on previous research on the bio-optics of jaundiced newborn skin, a prototype of a~     smartphone application has been developed. This prototype will be evaluated in a clinical~     trial in two hospitals in Norway. A smartphone will be used to take picture of the skin of~     the newborn, and by using an algorithm an estimate of the bilirubin concentration is made.~     The results from these estimates will be compared to the bilirubin levels measured in~     standard blood samples, as well as the results from ordinary transcutaneous measurement~     devices.~   "
42723|NCT03007550|"~     This CLASS02-01 trial is a prospective, multicenter trial for laparoscopic total gastrectomy~     (LTG) and open total gastrectomy (OTG) in patients with clinical stage I~     (T1N0M0、T1N1M0、T2N0M0) gastric cancer. The primary purpose of this study is to evaluate the~     early operative morbidity and mortality and determine the safety of LTG compared with OTG for~     clinical stage I gastric adenocarcinoma. The second purpose is to evaluate the recovery~     course and compare the postoperative hospital stay of the patients enrolled in this study.~   "
42724|NCT03007537|"~     To testify the prevention of Erythropoietin on cardiac surgery associated-acute kidney~     injury, and trying to provide evidence for protecting the renal function and improving the~     prognosis for patients after cardiac surgery.~   "
42725|NCT03007524|"~     This is a prospective, randomized trial comparing different doses of rosuvastatin in patients~     with acute coronary syndrome post drug-eluting stents implantation. Through the study, the~     investigators aim to evaluate the effects of high dose rosuvastatin calcium on target~     vessel endothelialization and non-target vessel plaque stability. Moreover, the~     investigators may provide mechanically evidence of clinical application of high dose~     rosuvastatin in patients with acute coronary syndrome.~   "
42726|NCT03007511|"~     A First In Human Usability Open Label trial will be performed using the Fidmi Feeding device~     on 15 adult patients with a need for enteral feeding. The primary outcome will be to evaluate~     safety, usability and discomfort throughout the study~   "
42727|NCT03007498|"~     Check the safety under normal conditions of use through the verification of emergence signs~     of irritability and sensitisation of the genital mucosa.~   "
42728|NCT03007485|"~     Chronic Obstructive Pulmonary Disease (COPD), also known as emphysema, is the leading cause~     of hospitalization for older adults in the U.S., and a leading cause of death. Although there~     is no cure for COPD, a program called pulmonary rehabilitation (PR), which combines exercise~     and education, can help decrease re-hospitalizations and improve patients' quality of life.~     Unfortunately, very few COPD Latino and African-American patients actually get PR. These~     patients are unlikely to get referrals or to be able to attend PR due to lack of insurance,~     lack of transportation, or lack of a PR center in their area. Telehealth is a way of using~     computers to deliver healthcare long-distance, eliminating the need for a patient to travel~     to receive care. By using telehealth for PR, the patient can exercise on a stationary bike in~     his or her home, while being supervised by videoconference by a respiratory therapist (RT).~     The RT can see the patient, and deliver education by videoconference, and the patient can~     see the RT, so the patient does not need to leave home to get PR.~   "
42729|NCT03007472|"~     The purpose of this study is to gather long-term data on the FDA approved CI532 cochlear~     implant, and CP1000 (Nucleus 7) sound processor~   "
42730|NCT03007459|"~     Fitness athletes emphasize the value of staying lean, muscular and defined, and motivates and~     inspires followers through social media. We want to study the effect of such lifestyle on~     selected aspects of psychological and physical health in female fitness athletes, and compare~     the outcomes to a healthy, physically active female population.~   "
42731|NCT03007446|"~     This is a Prospective，Single-center，Single-arm，Open-label exploratory clinical trial~     evaluating the efficacy and safety of Conversion Surgery for Apatinib plus SOX for patients~     with unresectable gastric cancer.~   "
42732|NCT03007433|"~     Dyspeptic symptoms such as abdominal pain, bloating and nausea after a meal are common;~     however the cause of these problems in many patients is often unclear despite medical~     investigation. This is because dyspeptic symptoms are only rarely related to acid reflux,~     stomach ulcers or cancer that can be diagnosed by endoscopy. Rather, the cause is abnormal~     stomach function, so-called functional dyspepsia, a condition in which the digestive system~     does not function normally after a meal. Gastric scintigraphy is the standard investigation~     of stomach function in patients with this condition. It involves eating a small test meal~     that includes a tiny dose of radioactive material so that the movement of food can be~     visualised as it empties from the stomach. An important limitation of this approach is that~     symptoms are rarely caused and delayed emptying after a small meal is present only in a~     minority of patients and, thus, the ability of this investigation to explain the cause of~     symptoms or guide medical treatment is limited.~      This research project is designed to compare three new investigations of stomach function~     using a relatively large meal. This information will help to explain the causes of symptoms~     after a meal. The investigations to be tested include: (1) Nutrient Drink Test, (2) Gastric~     Scintigraphy and (3) Magnetic Resonance Imaging. All three tests are safe, easy to perform~     and non-invasive (i.e. do not involve inserting catheters through the nose and into the~     stomach or taking blood). The results should provide more useful information to doctors~     looking after patients with dyspeptic symptoms.~      This study will compare test results from healthy volunteers, with patients attending clinic~     for investigation of dyspeptic symptoms. The aim is to document abnormal function of the~     stomach and intestines and to identify the causes of dyspeptic symptoms after a meal.~   "
42733|NCT03007420|"~     Post-traumatic headaches (PTH) are the most common complaint after traumatic brain injury,~     possibly generated by a number of stressors to the trigeminovascular and cervical plexus~     networks, including inflammation of the high cervical facet joints, traumatic cranial~     neuralgias, migraines, and myofascial injuries. To date, no treatment guidelines exist for~     PTH management except for conservative modalities, such as cognitive rest, physical therapy,~     and neuropathic pain medications, all of which have minimal evidence to support them.~      The investigators propose a randomized, controlled, clinical trial and prospective follow-up~     study to evaluate the effect of invasive procedures such as occipital nerve block (ONB) and~     cervical medial branch block (CMBB) in the management of PTH.~      Adolescents and young adults (14-35 years of age) will be recruited from Boston Children's~     Hospital and Beth Israel Deaconess Medical Center Pain clinics, Concussion clinics and~     Headache clinics.~   "
42896|NCT03005288|"~     This study will assess the safety, pharmacokinetics and efficacy of bimagrumab when~     administered in overweight and obese patients with type 2 diabetes~   "
42736|NCT03007381|"~     Background: Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug that has been~     shown to reduce breakthrough narcotic consumption following orthopaedic, neurosurgical, and~     obstetrical procedures. The morphine-sparing effect of ketorolac may reduce respiratory and~     central nervous system depression post operatively, while still providing adequate pain~     control for patients. Patients undergoing abdominally based microsurgical breast~     reconstruction may particularly benefit from ketorolac postoperatively, and ultimately be~     safely discharged from hospital sooner than their counterparts receiving standard of care.~      Research Question: In adult women post-mastectomy, undergoing abdominally based microsurgical~     breast reconstruction, does a postoperative regimen of intravenous ketorolac tromethamine, in~     addition to standard of care, reduce the length of postoperative hospital stay compared with~     an intravenous sham saline regimen?~      Study Design: A single center, explanatory, placebo-controlled, 1:1 allocation, 2-arm,~     parallel group, superiority, randomized, and double blinded, controlled trial.~      Population: The study population includes all females >18 years old post mastectomy~     consenting to abdominally based microsurgical breast reconstruction.~      Intervention and Comparator: The intervention will be ketorolac 30 mg IV every 6 hours~     postoperatively for 72 hours. The comparator will be a sham intravenous administration of~     normal saline.~      Outcomes: The primary outcome is hospital length of stay postoperatively. Secondary outcomes~     include visual analog scale for pain, breakthrough narcotic consumption, surgical drain~     outputs, hematoma, and other complications.~      Sample Size: Available data provided estimates for average length of hospital stay and~     standard deviation. A minimally clinically significant difference of 1 day was decided on due~     to expert opinion. Based on a power of 80% and alpha of 0.05, and inflated to account for~     attrition and efficiency losses, a total of 50 patients (25 per group) will be required for~     this study.~   "
42737|NCT03007368|"~     As populations become urbanized in Africa, the change to a more Westernized diet has been~     associated with rise in obesity and related metabolic syndrome diseases. The current study~     shows that in the West African Sahel, these replacement starchy staple foods have fast~     gastric emptying compared to traditional sorghum and millet foods; and implies that the~     latter could be beneficial in lowering glycemic response, providing energy from a meal over a~     longer time, and providing a satiety effect. Knowledge of this attribute of sorghum and~     millet foods could be useful to improve their image in West African cities to increase their~     consumption and to improve markets for local smallholder farmers.~   "
42738|NCT03007355|"~     Hypotensive anesthesia is effective in reducing the intraoperative blood loss. The risk of~     hypoperfusion of vital organs continues to be a concern. An adequate monitoring of tissue~     perfusion and oxygenation is crucial issue. Peripheral Perfusion Index (PPI) as a noninvasive~     new monitoring, can reflect the peripheral perfusion dynamics.~      This study is designed to explore the behavior and trend of PPI during deliberate hypotensive~     anesthesia in adult patients undergoing functional endoscopic sinus surgery (FESS).~   "
42739|NCT03007342|"~     The aim of this prospective, randomized, placebo controlled study is to evaluate the effect~     of amoxicillin/clavulanic acid combination on post-operative pain and swelling in adult~     patient with symptomatic apical periodontitis.~   "
42740|NCT03007329|"~     SGLT2 antagonists and GLP1 agonists are used since a relatively short period as second line~     therapy if indicated and are well tolerated by patients featuring low risk of hypoglycaemia~     in comparison to insulin or other oral glucose lowering drug. This new treatment options~     offer an effective modality to lower blood glucose, if first line therapeutics fail.~     According to national and international guidelines combination of oral glucose lowering drugs~     is possible in multiple ways, but is currently not recommended for GLP1 agonists and SGLT2~     inhibitors yet, as evidence and supporting studies are missing proving efficacy and safety].~     Thus studies under standardized conditions are urgently needed to answer these unsolved~     questions.~      First results of a combination of a SGLT2 Inhibitor and a GLP1 agonist demonstrated huge~     potential regarding glucose and weight reduction and safety issues. However, further studies~     are necessary to elucidate potential mechanisms of combination therapy with SGLT2 inhibitors~     and GLP1 agonists and its effect on weight loss, glucose control, effects on incretins and~     adipokines, as well as further effects on ectopic lipid accumulation in liver and other~     tissues as myocard or pancreas in humans.~      As both monotherapies have effects on weight and metabolism, changes in abdominal,~     subcutaneous, hepatic, myocardial or pancreatic lipid content might be speculated and are~     focus of interest in this study. Recently GLP1 agonists were shown to have effects on hepatic~     lipid reduction in humans with diabetes.~      Hepatic lipid content and steatosis hepatis are widely discussed to have major effects on~     progression of diabetes and cardiovascular disease. Thus reduction of lipid accumulation in~     hepatic tissue might have an effect on diabetes progression.~      Also higher myocardial lipid accumulation is seen in diabetic patients probably partly~     responsible for higher cardiovascular risk in diabetics. So far results combining these two~     drug classes show less weight loss as might have been expected using monotherapy, so that~     further investigation will definitely shed light on combination of therapeutic concepts.~      Facing a multiple of positive side effects (weight loss, blood pressure lowering, potential~     protective cardiac effects) using a combination of SGLT2 and GLP1 seems to be a promising~     therapeutic option in diabetic subjects.~   "
42741|NCT03007316|"~     An array of soft tissue augmentation techniques have been employed concomitant to implant~     placement, as free connective tissue grafts or pedicle grafts for keratinized tissue~     thickening in attempt not only to augment the soft tissue for better resistance to~     inflammation and improved esthetic stability, but to preserve buccal bone thickness as well.~      Results obtained from the literature were controversial regarding the need of soft tissue~     augmentation to curb buccal bone resorption and preserve pink esthetics. Scarce literature~     was found, that monitored the ridge alterations following implant placement.~      Our study will monitor the effect of soft tissue augmentation on soft tissue esthetics and~     buccal bone resorption during the process of remodeling in a measurable way.~   "
42742|NCT03007303|"~     This study investigates the relationship of circulating microRNA-30e and schizophrenia, and~     shows the relevance of the aberrant microRNA-30e expression in plasma with the variation~     disease status.~   "
42743|NCT03007290|"~     Clinical usefulness of therapeutic drug monitoring of colistin in patients treated with~     colistin~   "
42744|NCT03007277|"~     The PANJO study aims to evaluate, within the French public health services, the impact of a~     home visitors training on parent-child attachment, families outcomes, use of services and~     child maltreatment indicators.~   "
42745|NCT03007264|"~     In this study the application of cold atmospheric plasma (CAP) will be tested on intact skin~     of volunteers. To test safety, several skin parameters will be monitored, the antimicrobial~     effect will be investigated as well. The investigators expect this treatment to have a good~     antimicrobial effect with acceptable, transient skin sensations.~   "
42746|NCT03007251|"~     The purpose of this study is to investigate different effects of Eurythmy Therapy on~     psychological and physiological parameters of circulation and thermoregulation~   "
42747|NCT03007238|"~     This phase II trial studies efficacy of extracorporeal photopheresis and low dose aldesleukin~     (interleukin-2) in treating patients with chronic graft-versus-host disease (cGVHD) that does~     not respond to upfront treatment with steroids. In graft-vs-host disease, patients have a~     small quantity of a white blood cell called T regulatory cells or T-reg cells that helps to~     control the immune system. Extracorporeal photopheresis is a procedure where patient's blood~     is removed and treated with ultraviolet light and drugs that become active when exposed to~     light. The treated blood is then returned to the patient and may be effective in increasing~     T-reg cells in patients with cGVHD. Aldesleukin increases the activity and growth of white~     blood cells, and it has shown to enhance T-reg cells in patients with cGVHD and may be~     effective improving GVHD symptoms.~   "
42750|NCT03007199|"~     The AGNES case-control set consists of individuals with a first acute ST-elevation myocardial~     infarction. AGNES cases have ECG- registered ventricular fibrillation occurring before~     reperfusion therapy for an acute and first ST-elevation myocardial infarction. AGNES controls~     are individuals with a first acute ST-elevation myocardial infarction but without ventricular~     fibrillation. All cases and controls are recruited at seven heart centers in The Netherlands.~     The investigators' exclude individuals with an actual non-ST-elevation myocardial infarction,~     prior myocardial infarction, congenital heart defects, known structural heart disease, severe~     comorbidity, electrolyte disturbances, trauma at presentation, recent surgery, previous~     coronary artery bypass graft or use of class I and III antiarrhythmic drugs. Individuals who~     develop ventricular fibrillation during or after percutaneous coronary intervention are not~     eligible. Furthermore, because early reperfusion limits the opportunity of developing~     ventricular fibrillation, potential control subjects undergoing percutaneous coronary~     intervention within 2 h after onset of myocardial ischemia symptoms were not included. This~     time interval is based on the observation that >90% of cases develop ventricular fibrillation~     within 2 h after onset of the complaint of symptoms.~   "
42751|NCT03007186|"~     This study aims to show whether the hyperglycaemic phases following a treatment with~     glucocorticoids, as well as blood measurements correlated to high blood glucose levels and~     insulin resistance, vary significantly between patients with and without gestational diabetes~     mellitus.~   "
42752|NCT03007173|"~     Umbilical pilonidal sinus (UPS) is a rare disease of young, hirsute, dark men with deep~     navels and poor personal hygiene; however, it can be seen in females. UPS could easily be~     misdiagnosed and mistreated due to its rarity and lack of awareness in physicians. Diagnosis~     is easy to establish with physical examination and a detailed history. Treatment is generally~     depending on the severity of the disease, ranging from good personal hygiene to surgical~     excision of umbilical complex. The treatment of choice for chronic, intermittent cases is~     surgical removal of the affected portion; paying special attention to cosmetic appearance~     especially in female patients. In this report, we present two cases of UPS, one in a man and~     one in a woman with the explanation of its etiopathogenesis and surgical treatment.~   "
42753|NCT03007160|"~     Assess the efficacy and safety of potassium citrate extended-release tablets on Urolithiasis~     formation or recurrence.~   "
42754|NCT03007147|"~     This randomized phase III trial studies how well imatinib mesylate and combination~     chemotherapy work in treating patients with newly diagnosed Philadelphia chromosome positive~     acute lymphoblastic leukemia. Imatinib mesylate may stop the growth of cancer cells by~     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, work in~     different ways to stop the growth of cancer cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Giving imatinib mesylate and~     combination chemotherapy may work better in treating patients with Philadelphia chromosome~     positive acute lymphoblastic leukemia.~   "
42755|NCT03007134|"~     The purpose of this study is to (1) compare a technically improved assay with an existing~     assay used to measure serum anti-GM-CSF antibodies in stored serum samples previously~     obtained from patients diagnosed with either primary, secondary, congenital or idiopathic~     pulmonary alveolar proteinosis (PAP), other chronic diseases or disease-free, healthy~     individuals; (2) determine the prevalence and levels of anti-GM-CSF autoantibodies and (3)~     define the breadth of the autoimmune antibody responses in primary PAP patients from the~     United States, Japan, Australia, and Europe using previously collected serum samples; and (4)~     using a chart review approach, compare the clinical, radiologic and laboratory features of~     primary PAP patients to determine if differences exist among patients in these globally~     geographically distributed regions.~   "
42756|NCT03007121|"~     The purpose of this study is to determine which postoperative analgesia is optimal after~     colorectal surgery. The investigators will compare intrathecal morphine, continuous epidural~     analgesia and standard systemic analgesia. All patients will have the possibility to~     administer themselves intravenous morphine as needed.~   "
42757|NCT03007108|"~     The aim of this study is to establish normal values of thrombin generation assay parameters~     in pediatrics, according to different age groups. The standardized thrombin generation assay~     Genesia™ will be used. Different age groups of healthy children will be recruited :~     neonates, 1-3 months, 3-6 months, 6-12 months, 1-2 years, 2-6 years, 6-12 years, and 12-15~     years old. Adults values will be obtained (healthy adults > 18 years old).~   "
42758|NCT03007095|"~     The study aims at investigating social cognition outcomes of children born prematurely.~     Social cognition can be briefly defined as a process which underlines people's social and~     emotional behaviors. There are behavioral and cognitive evidences indicating that preterm~     children have executive dysfunctions. Executive functions refer to multiple cognitive~     processes that contribute to human higher order abilities, such as purposeful and~     future-orientated behavior. The literature regarding development of term born children~     indicates that executive functions are linked to the emergence of social cognition. Then, the~     investigators asked if children born prematurely, as they commonly present executive~     dysfunctions, would show an atypical development of social cognition. Additionally, as it has~     been shown that parental anxiety is a key factor of preterm children development, the~     investigators assumed that it should play a role in social cognition outcomes.~   "
42759|NCT03007082|"~     This is a multicenter, prospective registry clinical study to evaluate the real-world~     efficacy and safety of intra-arterial treatment for acute ischemic stroke using Revive SE~     device on the basis of standardised medical treatment.~   "
42760|NCT03007069|"~     Using growth factors obtained from patient's venous blood mixed with particulate autogenous~     bone the study compares bone gain by implant with gold standards.~   "
42761|NCT03007056|"~     The HIFLO study evaluates the impact of HFNC oxygen therapy on duration of nCPAP therapy,~     oxygen therapy and hospitalization. The cost of use of CPAP and two HFNC devices are also~     evaluated.~   "
42762|NCT03007043|"~     To evaluate the difference in the prevalence of the main FSHR polymorphism (ASN680Ser), as~     well as other, less studied, gonadotropin polymorphisms between ovarian response groups,~     following ovarian stimulation~   "
44368|NCT02986048|"~     The purpose of this study is to establish a database (or registry) of patients treated with~     proton beam therapy at the University Hospitals (UH) Proton Therapy Center. By keeping track~     of the patients treated it will allow the investigators to periodically evaluate the outcomes~     of patients.~   "
42763|NCT03007030|"~     The goal of this clinical research study is to learn if Adcetris (brentuximab vedotin) can~     help to control mesothelioma. The safety of this drug will also be studied.~      This is an investigational study. Brentuximab vedotin is FDA approved and commercially~     available for the treatment of Hodgkin lymphoma and anaplastic large cell lymphoma. It is~     considered investigational to use brentuximab vedotin in patients with mesothelioma. The~     study doctor can explain how the study drug is designed to work.~      Up to 50 participants will be enrolled in this study. All will take part at MD Anderson.~   "
42764|NCT03007017|"~     Despite many efforts to increase the size of the donor pool, there is a large and growing~     disparity between the number of donor kidneys available for transplantation and the number of~     patients on the transplant waiting list. Increasing the quality of currently available donor~     kidneys would potentially improve the longevity of deceased donor kidney transplants by~     years, thus increasing the rate of transplantation patients on the kidney transplant waiting~     list. In addition, recipients of higher quality kidneys have shorter hospital stays and lower~     total hospital charges. By innovating the organ donation process, such that deceased donor~     kidneys are removed prior to the cessation of cardiac activity, rather than after, it may be~     possible to improve the quality of the kidney before transplantation, resulting in improved~     function after transplantation and increased longevity of these transplanted kidneys.~     Further, this improved kidney quality is highly likely to translate to reduced need for renal~     dialysis and other high-cost interventions, yielding lower total hospital charges. In this~     study we will test the hypothesis that, through a cost-free technical innovation, the quality~     of deceased donor kidneys could be improved significantly, saving thousands more lives per~     year and reducing total health care expenditures on renal transplantation.~   "
42765|NCT03007004|"~     Efficacy and safety of local infusion of botulinum toxin type B in patients with systemic~     sclerosis (SSc) with digital ulcer is evaluated by a randomized, double-blind study.~   "
42766|NCT03006991|"~     This study will integrate Pharmacogenomics and Pharmacometrics, to explore an effective~     concentration of MTXPGn for JIA pediatric patients, and set up a Population Pharmacokinetics~     model to provide reference for individual administration on JIA pediatric patients.~   "
42767|NCT03006978|"~     The purpose of this study is to evaluate the clinical utility, safety, and effectiveness of~     the TearCare™ System compared to standardized warm compress therapy for the application of~     controlled, localized heat therapy in adult patients with dry eye syndrome.~   "
42768|NCT03006965|"~     The purpose of this study is to describe the pharmacokinetic profile of patients with~     hemophilia A in prophylaxis in Spain using myPKFit®~   "
42769|NCT03006952|"~     This study was designed to assess the efficacy of adding pentoxifylline to losartan in~     comparison with increasing dose of losartan in type 2 diabetes patients with nephropathy.~     also the effect of pentoxifylline on N terminal brain natriuretic peptide (NT-pro BNP) and~     C-reactive protein~   "
42770|NCT03006939|"~     Extensive tumour debulking challenges both surgeon and anaesthesiologist but promotes~     survival in late-stage ovarian cancer patients. Little is known about the intraoperative~     fluid balance and its impact on morbidity and mortality.~   "
42771|NCT03006926|"~     This is an open-label Phase 1b study designed to evaluate the tolerability and safety of~     lenvatinib in combination with pembrolizumab in participants with hepatocellular carcinoma~     (HCC). The Expansion part of the study will evaluate objective response rate and duration of~     response by modified Response Evaluation Criteria In Solid Tumors for HCC (mRECIST) and~     RECIST 1.1 based on independent imaging review~   "
42772|NCT03006913|"~     Using mixed methods, investigators will conduct a multicenter partially randomized preference~     noninferiority trial with high-risk English-, Spanish-, and Cantonese-speaking patients~     assigned by (1) patients´ preference or (2) randomization to three counseling modes: (a)~     in-person; (b) phone; or (c) video conference. A total of 600 patients will complete~     counseling and 540 will complete the final survey. Baseline and post-counseling surveys will~     use validated measures (adapted for literacy and language) of study outcomes. All counseling~     sessions will be audio-taped. A sample of 90 tapes will be analyzed for counseling content~     and to identify 30 participants for in-depth interviews and analysis triangulating all forms~     of data. Genetic counselors will be interviewed in depth to elicit their perceptions of the~     strengths and limitations of each counseling mode.~   "
42773|NCT03006900|"~     Pilates is becoming popular among the multiple sclerosis (MS) community as an alternative to~     the more traditional exercise programs. Although somewhat limited, previous research has~     suggested Pilates may have some beneficial effects in MS. This 12-week, single-blinded,~     randomized controlled study has one intervention group (Pilates and massage therapy) and one~     control group (massage therapy only). The primary outcome of interest is the change in~     walking ability between groups. Secondary outcomes include other measures of physical~     performance and quality of life.~   "
42774|NCT03006887|"~     This is an open-label Phase 1b study designed to confirm the tolerability and safety of~     lenvatinib in combination with pembrolizumab in participants with selected solid tumors~     (non-small cell lung cancer, predominantly clear cell renal cell carcinoma, endometrial~     carcinoma, urothelial carcinoma, squamous cell carcinoma of the head and neck, or melanoma~     [excluding uveal melanoma]).~   "
42775|NCT03006874|"~     The purpose of this study is to confirm the efficacy of CJ-12420, Once daily (QD), compared~     to esomeprazole in patients with erosive esophagitis classified as Los Angeles (LA)~     classification grades A to D at Week 8.~   "
42776|NCT03006861|"~     Creatine is a nutritional supplement that is often ingested to improve exercise performance.~     The advent of a new product that is applied to the skin overlying muscle offers potential~     benefit, if the creatine can be targeted to specific muscles. The investigators are testing a~     novel creatine cream to determine the effects on human muscular performance. The~     investigators are assessing whether 7 days of topical creatine application is additive to~     orally-ingested creatine for improving muscular power (determined by knee extension).~   "
42788|NCT03006705|"~     The purpose of study is to evaluate the efficacy and safety of postoperative adjuvant~     chemotherapy with Nivolumab in combination with tegafur-gimeracil-oteracil potassium (S-1~     therapy) or capecitabine + oxaliplatin (CapeOX therapy), in comparison with placebo in~     combination with S-1 therapy or CapeOX therapy, in pStage III gastric cancer (including~     esophagogastric junction cancer) after D2 or more extensive lymph node dissection.~   "
42777|NCT03006848|"~     This clinical trial seeks to determine if avelumab will be effective in facilitating removal~     of all gross tumor in the event of a relapse of osteosarcoma in pediatric patients. Avelumab~     will be evaluated using dosing that has previously been determined in adult studies.~      Primary Objectives:~        -  To estimate the response rate to 4 cycles of avelumab in patients with recurrent or~          progressive osteosarcoma.~        -  To estimate the 16-week progression free survival of patients with recurrent or~          progressive osteosarcoma after treatment with avelumab.~      Secondary Objective:~        -  To describe the toxicities associated with the administration of avelumab in patients~          with recurrent or progressive osteosarcoma.~        -  To assess the quality of life of patients with recurrent or progressive osteosarcoma~          undergoing treatment with avelumab, and to explore relationships between clinical~          factors and patient-reported health-related quality of life (HRQOL) outcomes.~      Exploratory Objectives:~        -  To explore factors associated with response in patients treated with avelumab after~          recurrent or progressive osteosarcoma (e.g. tumor PD-L1 expression).~        -  To measure parameters of immune activation including subsets of peripheral blood~          mononuclear cells (PBMCs) and serum markers of immune activation.~        -  To evaluate the role of T-cells in immune checkpoint blockade via measures of cell~          proliferation, co-inhibitory receptor expression on CD8 T cells, T cell repertoire, and~          epigenetic programming.~   "
42778|NCT03006835|"~     This is a single-center, randomized, single-blind, investigator-initiated, pharmacological~     study with a parallel design. Patients with non-ACS undergoing primary percutaneous coronary~     intervention will be randomized after informed consent, in a 1:1:1:1 ratio to the following~     treatment groups:~      Group Α: Domestic Clopidogrel 300mg as a loading dose before PCI, followed by 75mg per day.~      Group B: Domestic Clopidogrel 600mg as a loading dose before PCI, followed by 75mg per day.~      Group B: Imported Clopidogrel 300mg as a loading dose before PCI, followed by 75mg per day.~      Group D: Imported Clopidogrel 600mg as a loading dose before PCI, followed by 75mg per day.~      Platelet inhibition ratio assessment by thrombelastogram will be performed，2 hours after the~     loading dose(Day 0)， 6 hours after thrombelastogram (Day 0), 30 day after thrombelastogram.~     Documentation of major adverse cardiac events (death, myocardial infarction, stroke,~     revascularization procedure with PCI or CABG) and serious adverse events (bleeding, other~     adverse events)will be performed until Day 30.~   "
42779|NCT03006822|"~     Background: Latent myofascial trigger points (MTrPs) of the levator scapulae are high~     prevalent and may influence the neck and shoulder conditions. The pressure release is one of~     the most recommended manual therapy techniques.~      Objective: To determine the time effect of the pressure release technique application in the~     latent MTrPs of the levator scapulae muscle.~      Design: A three-arm (1:1:1 ratio), double-blinded, parallel, randomized clinical trial.~      The manual technique than us apply, be sustained digital pressure with thumbs or with the~     2nd-3rd fingers on the PGM below the pain threshold and gradually increases up to a ceiling~     of tissue resistance (barrier), as decreases, adds more pressure. different times of~     sustained pressure and the number of repetitions depending on time 30 (group 1, acts as a~     control), 60 (group 2) and 90 seconds (group 3) shall apply.~   "
42780|NCT03006809|"~     This is a prospective unblinded, randomized trial for the use of Fecal Microbiota~     Transplantation (FMT) for the treatment of Ulcerative Colitis (UC), in combination with or~     without antibiotic pretreatment.~   "
42781|NCT03006796|"~     This is an observational prospective study of azilsartan medoxomil / chlorthalidone compared~     with irbesartan / hydrochlorothiazide in routine therapy of patients with arterial~     hypertension and obesity.~   "
42782|NCT03006783|"~     A retrospective and cross-sectional analysis of standard of care for facial paralysis~     involving the cross-face nerve graft in the past 20 years.~        -  Imagery analysis~        -  Questionnaires~   "
42783|NCT03006770|"~     This will be a randomized, placebo-controlled, parallel group, multicenter, Phase III~     study.The study aims to evaluate the Efficacy, Tolerability and Safety of Intramuscular~     Injections of PLX PAD for the Treatment of Subjects with Critical Limb Ischemia (CLI) with~     Minor Tissue Loss (Rutherford Category 5) who are Unsuitable for Revascularization.~   "
42784|NCT03006757|"~     The purpose of this study is to compare the effect of rapid heat cured acrylic resin material~     with titanium dioxide nanoparticles added to conventional acrylic resin material on the~     biting force of the single maxillary complete denture .~   "
42785|NCT03006744|"~     The promotion of language and communicative development in the early years is extremely~     important. Children who enter school with good language skills have better educational and~     economic success. This study is part of a large project across Liverpool, Manchester and~     Sheffield Universities to determine how shared reading promotes child language development,~     and use this knowledge to make it an effective language boosting tool for children across the~     whole socio-economic spectrum. The overall project includes:~        -  observational studies to identify what language boosting behaviours are responsible for~          shared reading's effectiveness, and how parents from different socio-economic groups use~          these behaviours during shared reading;~        -  intervention studies to evaluate packages designed to train parents in the use of~          specific language boosting behaviours during reading;~        -  a qualitative exploration of the reasons people may not read with their children.~      This study will provide training to parents on how to develop their children's attention to~     the features of words while reading books with them. The research questions are:~      i) Is specific training focused on the sound properties of words during shared reading more~     effective at developing children's phonological awareness and language than general advice on~     the importance of reading with children? ii) Do children with speech sound disorder and~     typically developing children respond differently to intervention? iii) To what extent are~     differences in training implementation and effects explained by socio-economic status?~      Our participants will be parents and their children, aged 30-54 months, with a diagnosis of~     speech sound disorder. They will be recruited via speech and language therapy services in the~     North West. Data collection will be carried out by the research team in participants' homes,~     taking 3-4 hours in total over 2-3 appointments. The sessions will be audio-recorded; parents~     will complete questionnaires, and children's language and speech will be assessed with~     standardised and in-house tests.~   "
42786|NCT03006731|"~     The purpose of this study is to compare the effects of an exercise training strategy called~     high-intensity interval training (HIIT) to moderate intensity continuous exercise (MICE), on~     walking function and cardiovascular fitness in stroke patients. Hypothesis: HIIT will result~     in significantly greater benefit to fitness and mobility than MICE.~   "
42787|NCT03006718|"~     The overall goal of the project is to reduce pain-related, 30-day readmission rates for~     sickle cell disease (SCD) patients. The investigators want to see if a mobile phone~     application (app) can help decrease the need for repeat admission to the hospital because of~     sickle cell pain.~   "
44424|NCT02985320|"~     The purpose of this study is to evaluate the safety of sIPVs of different dosages in adults,~     children and infants in a phase I open-label study, and then assess its immunogenicity and~     safety in healthy infants between 60 and 90 days old in a phase II blind, randomized, and~     controlled study.~   "
42789|NCT03006692|"~     In the anesthesiologist-manned mobile emergency car unit an analyzing device for blood gas~     testing is present since 2014. This study will determine if a prehospital arterial blood gas~     helps the doctor to make more precise diagnosis prehospitally. Furthermore it will be~     determined if the doctors find this device helpful in assessing and treating patients with~     affected consciousness.~   "
42790|NCT03006679|"~     The purpose of this study is to determine the efficacy, safety, tolerability, and~     pharmacokinetics (PK) of meropenem-vaborbactam compared to piperacillin/tazobactam for 7 to~     14 days in the treatment of hospitalized adults who meet clinical, radiographic, and~     microbiological criteria for hospital-acquired bacterial pneumonia (HABP) or~     ventilator-associated bacterial pneumonia (VABP).~   "
42791|NCT03006666|"~     Cluster randomized trial to test the impact of peer health coaches on prediabetic patients.~     This study will test a scalable model of peer health coaching to address the millions of~     patients at risk for Diabetes Mellitus, using low cost, culturally congruent personnel to~     promote prevention of Diabetes Mellitus in patient-centered medical home (PCMH) practice.~   "
42792|NCT03006653|"~     Understanding Daily Fluctuations in Self-Regulation, also known as the Digital Marshmallow~     Test (DMT), is a collaboration by Northwell Health, Cornell Tech, and Sage Bionetworks.~     Funded by the Robert Wood Johnson Foundation, this is a pioneering study to advance the~     science in identifying and helping individuals who act on short-term temptations, despite~     long-term consequences. Using Apple's ResearchKit(™) and Android's ResearchStack~     applications, the Digital Marshmallow Test will leverage the powerful capabilities of the~     smartphone to examine impulsivity using a range of game-like tasks and sensor capabilities~     within the mobile phone. Across studies, more impulsive individuals are significantly more~     likely to suffer from obesity, Type II Diabetes, substance abuse, gambling problems, suicidal~     behaviors, and increased criminality among many other problems. Early self-report studies~     reveal a relationship between the inability to delay gratification and different patterns of~     mobile phone use. This will be the first study to develop non-invasive mobile methods to~     identify and help those at greatest risk for impulsive responding before serious problems~     occur.~   "
42793|NCT03006640|"~     Clinicians are increasingly dealing with morbid obese patients. In morbid obese patients,~     difficult sampling and problems encountered with noninvasive blood pressure monitoring makes~     arterial cannulation an essential skill in many situations like surgeries or trans-radial~     procedures for coronary or carotid interventions.~      Radial artery has been preferred over other sites for arterial cannulation due to low~     incidence of bleeding, better hemostats, more comfort, and immediate ambulation. sm In this~     study, subcutaneous nitroglycerin will be used to facilitate radial artery cannulation aiming~     to decrease insertion time, increase success rate and decrease related complications~   "
42794|NCT03006627|"~     Opioids are widely used for pain relief after major abdominal surgeries[1]. Sex differences~     in the opioid analgesia have been reported and investigated in human subjects and animal~     models In this study, effects of sex difference on response to opioid analgesics after~     abdominal surgeries will be assessed regarding; analgesic duration (primary variable),~     frequency of analgesic requirement, total opioid consumption, Opioid related complications~     (respiratory depression, Nausea & vomiting, itching, over-sedation, delayed intestinal~     motility).~   "
42795|NCT03006614|"~     This study aims to explore new PERS prediction model can improve the pathological complete~     response rate of neoadjuvant chemotherapy of breast cancer and disease-free survival.~   "
42796|NCT03006601|"~     This study aims to determine the treatment effect of vision therapy on myopic children by~     assessment of accommodative function before and after therapy.~   "
42797|NCT03006588|"~     EUS-FNA for RPLN in NPC~   "
42798|NCT03006575|"~     This Phase II randomized study is to determine the efficacy of consolidation chemotherapy~     after split irradiation with concurrent chemotherapy in locoregional recurrence of non-small~     cell lung cancer after surgical resection~   "
42799|NCT03006562|"~     The PREVENTER Trial aims to compare the use of perioperative pharmacologic prophylaxis~     (subcutaneous heparin) with intermittent pneumatic compression devices (IPCs) to the use of~     IPCs alone for the prevention of venous thromboembolism (VTE) after radical prostatectomy~     (RP).~   "
42800|NCT03006549|"~     Despite increasing interest in emergency manuals (EMs), relatively little is known about~     their effectiveness and limitations in the perioperative setting. Prior studies have been~     limited in that they evaluated EMs using crises that were tailor-made to match one of their~     chapters, and there has been minimal participation by attending surgeons and other~     experienced personnel. The Investigators' preliminary experience suggests less-than-expected~     EM use and suboptimal usage, which may be due to the simulation scenario falling halfway~     between two different chapters of the EM, raising the question of whether limitations were~     due to the EM content, team dynamics, or inadequate training in the EM use. In this~     randomized, prospective, two-center simulation-based study, the investigators utilize~     clinical scenarios specifically designed to observe the patterns of use and to test the~     limitations of the EMs. The hypothesis is that EMs may not improve, and may even worsen,~     clinical performance in situations that do not exactly match a specific chapter of that EM,~     and that EM usage patterns will identify both strengths and limitations of the tools and its~     implementation. The participating healthcare providers consisting of experienced surgeons,~     anesthesiologists, and nurses will be randomized into four experimental groups, each exposed~     to either a specific or non-specific simulation scenario, along with or without the~     availability of the EM. The major experimental endpoint will be how many critical actions~     each team performs, scored as the percentage of actions taken from a pre-determined list. The~     goal of this study is to improve EM content and use by understanding its limitations during~     interprofessional team-training simulations and to study whether EMs enhance or detract from~     clinical performance. This is especially a concern in situations that do not exactly match a~     specific chapter of the EM, such as cases that are vague and represent multi-factorial~     diagnostic dilemmas such as hypotension and hypoxemia. The ultimate goal is to strengthen~     patient safety by providing guidance for improving EM content, use, and training protocols.~   "
42801|NCT03006536|"~     The proposed mechanism of action for LI-ESWT in ED is that it improves endothelial function~     and triggers angiogenesis through induction of local growth factors and endothelial nitric~     oxide synthase. The literature generally confirms that LI-ESWT is safe and cohort studies~     investigating the clinical effects have been encouraging. Meanwhile, randomized trials have~     shown contradictory results. Thus, a randomized trial in 67 PDE5-I responders showed~     statistically greater improvements in the Erectile Function Domain of the International Index~     of Erectile Function (IIEF) with active LI-ESWT treatment compared to a sham treatment~     (p=0.032).~   "
42802|NCT03006523|"~     To prospectively determine the most appropriate inseminated volume in donor IUI cycles. It is~     hypothesized that if the procedure is performed with 0.5 mL instead of 0.2, higher clinical~     pregnancy rates will be achieved by promoting higher sperm densities in the fallopian tubes~     at the time of ovulation by decreasing the amount of sperm cells lost during preparation and~     handling.~   "
42803|NCT03006510|"~     Our goal for this Learning Healthcare System Demonstration Project is to reduce the rate of~     inpatient hypoglycemia. Hypoglycemia can result in longer lengths of stay and increased~     morbidity and mortality (ie falls and cardiovascular or cerebral events).~      The group at Washington University (WSL) developed a predictive hypoglycemia risk score.~     Using current glucose, body weight, creatinine clearance, insulin type and dosing, and oral~     diabetic therapy, they identified patients at high risk for hypoglycemia and then provided~     in-person education to the providers of these patients. This resulted in a 68% reduction in~     severe hypoglycemia (blood glucose < 40 mg/dL). This approach required significant personnel~     hours and is difficult to replicate in other systems.~      We will implement an EHR-based intervention at UCSF to predict which patients are at high~     risk of inpatient hypoglycemia and take action to prevent the hypoglycemic event. In real~     time, all adult (non OB) patients with a glucose < 90, and a high risk of future hypoglycemia~     (based on the WSL formula) will be identified. Patients will be randomly assigned to~     intervention or no intervention (current standard care). The intervention will consist of an~     automated provider alert with recommendations on what adjustments could be made to avoid a~     potentially serious hypoglycemic event.~      The outcomes that will be measured include: 1) reductions in serious hypoglycemic events, 2)~     monitor the changes made by providers as a result of alerts in order to study provider~     behavior and identify future areas of intervention, and 3) provider satisfaction with the~     alert system.~   "
42804|NCT03006497|"~     The aim of this study is to investigate the efficiency of an exercise program based on~     principles of motor learning in correction of Forward Head Position (FHP) in asymptomatic~     patients.~   "
42805|NCT03006484|"~     Little is known about the long-term neurological outcomes after in-hospital cardiac arrest~     (IHCA). It is also not known whether withdrawal of life-sustaining measures will influence~     rates of survivors with poor neurological status. Currently, withdrawal of care in comatose~     patients after cardiac arrest is strongly forbidden by law in Korea. However, a new~     legislation on allowing withdrawal of care will come into effect since early 2018 in Korea.~     The investigators aim to determine 1) long-term neurological outcomes in patients who~     developed IHCA, 2) whether early neurological status can predict late neurological status~     after IHCA, and 3) whether the proportion of IHCA survivors with good neurological outcomes~     will change since implementation of new legislation on withdrawal of care.~   "
42806|NCT03006471|"~     Prediabetes is defined as an intermediate metabolic state that leads to the development of~     type 2 diabetes mellitus (DM2) and the prehypertension is a category assigned to identify~     patients who are at risk of developing hypertension (AH), in both pathologies the~     abnormalities in the variation of blood pressure (BP) has been related to organ damage, its~     evaluation is performed by ambulatory blood pressure monitoring (ABPM).~      Dapagliflozin is a selective and reversible inhibitor of the sodium-glucose co-transporter~     type 2 (SGLT-2), which reduces renal reabsorption of glucose and promotes the excretion of~     glucose through the urine, in the way that glucose blood. Another reported effects is the~     decrease on BP, so it would be interesting to evaluate this effects in patients with~     prediabetes and prehypertension, as a potential therapy to treat disorders and to prevent~     progression to DM2 and HT, respectively.~      The aim of this study is to evaluate the effect of Dapagliflozin on variability of blood~     pressure in patients with prediabetes and prehypertension without pharmacological treatment.~      The investigators hypothesis is that the administration of dapagliflozin decreases~     variability of blood pressure in patients with prediabetes and prehypertension without~     pharmacological treatment.~   "
42807|NCT03006445|"~     The purpose of this study is confirmatory investigation of safety and efficacy of FYU-981~     administered orally to hyperuricemic patients with and without gout for 34 or 58 weeks by the~     method of multicenter, open label and ascending dose regimen.~   "
42808|NCT03006432|"~     Gastric cancer is the fourth commonest cancer and the second largest cause of mortality from~     cancer. Surgical resection of localised forms of gastric cancer offers the only chance of a~     cure. The vast majority of patients, however, present with advanced disease from the outset~     (locally advanced or metastatic) or recurrent after resection of a localised form.~      For metastatic or locally advanced stages of gastric or gastro-oesophageal junction~     adenocarcinoma, the combination of 2 chemotherapy drugs (dual therapy) as compared with~     monotherapy or no chemotherapy, makes it possible to improve the tumour response and patient~     survival. Dual therapy comprising cisplatin + fluoropyrimidine (CF protocol) is considered as~     one of the first-line chemotherapy treatment standards.~      The addition of docetaxel to the CF regime (referred to as the DCF protocol) has made it~     possible to improve the tumour response rate, the time to tumour progression and overall~     survival in a randomised phase III trial. This improvement in treatment efficacy was~     achieved, however, at the expense of a significant increase in grade 3-4 toxicity, including~     diarrhoea , neutropenia, and neutropenia with complications. Although DCF is considered as a~     therapeutic standard for advanced forms of gastric cancer, its use is limited in clinical~     practice due to its high toxicity.~      Oxaliplatin has shown its usefulness in treatment of oesophagogastric cancer, with an~     efficacy at least equal to that of cisplatin. Peripheral sensory neuropathy was less common~     in the 5FU-cisplatin arm. In terms of treatment efficacy, 5FU-oxaliplatin versus~     5FU-cisplatin was associated with a non-significant improvement in median progression free~     survival rates, and overall survival.~      All these data thus suggest that 5FU-oxaliplatin is at least as efficacious and is better~     tolerated than 5FU-cisplatin, and also that docetaxel-5FU-cisplatin is more efficacious than~     5FU-cisplatin, with limited use due to its high toxicity. In the logical continuation of~     development of chemotherapy protocols for metastatic gastric cancer, the question therefore~     arises of the usefulness of adding docetaxel to 5FU-oxaliplatin, in terms of efficacy and~     also tolerance.~      In France, chemotherapy with FOLFOX is used extensively as a first line of treatment in~     advanced gastric cancer, but with progression-free survival and median survival rates that~     are still too low, and a poor response rate. The use of docetaxel at a dose of 50 mg/m2 every~     2 weeks in combination with FOLFOX (TFOX protocol) has shown very interesting results in~     phase II studies in terms of efficacy and tolerability, and these are worth confirming~     through a phase III randomised trial. In fact, if these results are confirmed in phase III,~     TFOX could become the new first-line therapeutic standard for advanced gastric cancer, while~     limiting toxicity and preserving patients' quality of life, and could become the reference~     treatment to accompany the targeted therapies currently being developed for this disease.~      The primary objective of this randomised phase III trial is to compare the progression-free~     survival on dual therapy with 5FU-oxaliplatin (FOLFOX protocol) with triple therapy with~     5FU-oxaliplatin-docetaxel (TFOX protocol) in treatment of advanced forms of gastric or~     oesophagogastric junction adenocarcinoma. The secondary objectives are overall survival, the~     tumour response rate, toxicity, quality of life and the therapeutic index, defined as the~     ratio between the median progression-free survival and the febrile neutropenia rate.~   "
42809|NCT03006419|"~     Demonstrate that low dose (3 mg/kg total ) rATG (thymoglobulin) has similar efficacy (delayed~     graft function, slow graft function, biopsy proven acute rejection episodes, infections,~     hospitalizations, adverse events, graft loss and death) than Basiliximab induction~   "
42810|NCT03006406|"~     Gonadotropin-releasing hormone analogue (GnRH-a) is a synthetic decapeptide compound which~     can down-regulate pituitary function causing a temporary low estrogen state. Since~     endometriosis is an estrogen-dependent disease, the use of long-acting GnRH-a can control the~     growth of endometriosis by inhibiting ovary function.Some scholars have found that, for~     adenomyosis patients who received a super long protocol (pretreatment of long-acting GnRH-a~     for 1-2 months) in IVF treatment, the pregnancy outcome is comparable to that of the controls~     with normal uterus. Thus, the aim of this study is to compare the clinical pregnancy rate in~     patients treated with GnRH-a for 1, or 2 months.~   "
42811|NCT03006393|"~     The main purpose of this study is to examine the effects of infliximab on measures related to~     depression symptoms. Infliximab is also known by its brand name Remicade. Infliximab, or~     Remicade, is given to by an intravenous (IV) needle and is currently used to treat rheumatoid~     arthritis and Crohn's disease. Infliximab is thought to help these conditions because it~     reduces inflammation in the body. Infliximab (Remicade) reduces inflammation by blocking a~     chemical in the body called tumor necrosis factor (TNF)-alpha. This chemical produces~     inflammation. Inflammatory chemicals in the body like TNF-alpha appear to be increased in~     some people with major depression. Researchers believe that a drug like infliximab, which~     blocks TNF-alpha, may be helpful in treating depression.~      This is a double-blind, placebo-controlled study in which participants will be randomized to~     receive one infusion of infliximab or placebo. The study will assess neuroimaging measures of~     corticostriatal circuitry before and after a placebo-controlled pharmacologic blockade of~     inflammation in 80 depressed patients.~   "
42812|NCT03006380|"~     Randomized controlled study to assess the efficacy and safety of the timing of administration~     of prophylactic oxytocin via intramuscular route (before compared to after placental~     delivery) on blood loss in vaginal delivery.~   "
42813|NCT03006367|"~     This is a open-label, single ascending dose, pharmacokinetic, and tolerability study of NFC-1~     in Children and Adolescents (Ages 6-17 Years) with ADHD.~   "
42814|NCT03006354|"~     In this prospective, randomised clinical trial the investigators aim to assess if nasal high~     frequency oscillatory ventilation (nHFOV) could be used as the primary modality of~     respiratory support in late preterm and term infants with transient tachypnea of the newborn~     requiring non-invasive ventilation.~   "
42815|NCT03006341|"~     The objectives of this study are, first, to identify select clinical covariates from~     electronic medical records (EMR) that might be associated with initiation of oral~     anticoagulant medications (dabigatran or warfarin) in patients with non-valvular atrial~     fibrillation (NVAF) at risk for stroke; second, to quantify the association between EMR-based~     clinical characteristics and patterns of insurance claims; third, to assess the potential for~     unmeasured confounding in dabigatran vs warfarin comparative effectiveness and safety studies~     based on administrative claims databases.~   "
42816|NCT03006328|"~     The GEM intervention leverages the patient-centered medical home model by using the GEM tool~     to provide individually tailored, patient-centered care at the time of the primary care~     visit, promote standardized weight management counseling by health coaches and primary team~     members, coordinate care between teams and other weight management service providers/programs~     (e.g., dietitians, health educators, DPP), and provide feedback to the provider and primary~     care team about patients' weight management-related goals, progress, and care.~   "
42817|NCT03006315|"~     Enrolled participants health status will be tracked by using a mobile health-monitoring~     device while undergoing chemotherapy for multiple myeloma.~   "
42818|NCT03006302|"~     This study will enroll patients who have metastatic pancreatic cancer and have progressed on~     prior chemotherapy.~      Half of participants will receive epacadostat/pembrolizumab/cyclophosphamide(CY)/GVAX~     pancreas vaccine followed by epacadostat/pembrolizumab/CRS-207 (Arm A), while the other half~     will receive epacadostat/pembrolizumab/CRS-207 (Arm B).~      The primary objectives of this study are to determine the recommended dose of epacadostat in~     this combination and assess survival of subjects in both treatment groups.~   "
42819|NCT03006289|"~     The purpose of this study is to investigate the association between metabolic syndrome (MS),~     body mass index (BMI), hyperglycemia, dyslipidemia, hypertension and thyroid cancer. Screen~     for the risk factors that affect the incidence of thyroid cancer.~   "
42820|NCT03006276|"~     Efficacy, Tolerability, and Safety of DFN-15 in episodic migraine with or without aura, being~     conducted at multiple centers in the United States.~   "
42821|NCT03006263|"~     The purpose of this study is to explore clinical outcomes of totally laparoscopic versus~     laparoscopy assisted total gastrectomy for gastric cancer.~   "
42822|NCT03006250|"~     The effects of desflurane versus sevoflurane in adult patients undergoing LMA anesthesia on~     respiratory events during a less than 2-hour elective surgery.~   "
42823|NCT03006237|"~     A Phase 1 Open Label Single Center Safety, Tolerability and Pharmacokinetic Study of IS-001~   "
42824|NCT03006224|"~     Smoking and perhaps secondary smoking is associated with many perioperative and postoperative~     complications, especially respiratory events. Hypoxemia and airway damage can be associated~     with secondary smoking. The aim of study is to predict the incidence of hypoxemia and airway~     damage during one lung ventilation for lobectomy.~   "
42825|NCT03006211|"~     To evaluate the mean changes in Endothelial Cell and Corneal pachymetry in eyes that operated~     under N2O + sevoflurane and O2 + sevoflurane general anesthesia.~   "
42826|NCT03006198|"~     The objective of this study is to explore and describe the disease characteristics, treatment~     and outcomes of participants with rheumatoid arthritis, ankylosing spondylitis, psoriatic~     arthritis, Crohn's Disease or ulcerative colitis as the major disease treated with REMICADE,~     SIMPONI or STELARA in clinical practice in the emerging regions of North Africa, the Middle~     East, and Western Asia.~   "
42827|NCT03006185|"~     Comparison of treatment efficacy and safety of pretreatment with ablative fractional laser~     versus microdermabrasion combined with large-area photodynamic therapy with methyl~     aminolevulinate for actinic keratoses~   "
42828|NCT03006172|"~     This is an open-label, multicenter, Phase I study designed to evaluate the safety,~     tolerability, and pharmacokinetics of GDC-0077 administered orally as a single agent in~     participants with locally advanced or metastatic Phosphatidylinositol-4,5-Bisphosphate~     3-Kinase Catalytic Subunit Alpha (PIK3CA)-mutant solid tumors, including breast cancer, and~     in combination with standard-of-care endocrine and targeted therapies for the treatment of~     locally advanced or metastatic PIK3CA-mutant hormone receptor-positive (HR+)/human epidermal~     growth factor receptor 2 negative (HER2-) breast cancer. Participants will be enrolled in two~     stages: a dose-escalation stage (Stage I) and an expansion stage (Stage II). Participants~     will be assigned to one of four regimens: GDC-0077 as a single agent (Arm A), GDC-0077 in~     combination with palbociclib and letrozole (Arm B), GDC-0077 in combination with letrozole~     (Arm C), or GDC-0077 in combination with fulvestrant (Arm D).~   "
42830|NCT03006146|"~     Autoimmune PAP is a rare lung disease affecting less than 5,000 individuals in US with no~     FDA-approved pharmacologic therapy. Results from off-label use in case reports and clinical~     studies completed outside of the US indicate that inhaled rhGM-CSF may be a safe and~     effective thera-py for autoimmune PAP. Preliminary clinical trials of inhaled rhGM-CSF in~     autoimmune PAP patients show promising results, 62%-96% therapeutic response rate without any~     identifiable drug-related adverse effects in at least 73 autoimmune PAP patients. However,~     the pharmacokinetics (PK), pharmacodynamics (PD), optimal dose, and treatment duration to~     maximize efficacy are unknown.~      The goal is to begin to address these knowledge gaps for inhaled sargramostim for autoimmune~     PAP patients with a pilot safety and PK/PD study (TPSC-110). TPSC-110, PharmPAP, which is a~     self-controlled open-label, phase I study to evaluate the safety, PK, and PD of inhaled~     sargra-mostim in autoimmune PAP patients. These results will impact the field by 1)~     confirming existing published data, 2) monitoring the local effects of inhaled sargramostim~     in autoimmune PAP patients, 3) potentially demonstrating a safe starting dose for a later~     trial to evaluate the therapeutic efficacy of inhaled sargramostim for autoimmune PAP.~   "
42831|NCT03006133|"~     The protocol is to show the prevalence of bruxism among a group of Egyptian children~   "
42832|NCT03006120|"~     Bleeding complications after cardiac catheterization have been reviewed previously, but there~     are very few studies on retroperitoneal hematoma and appropriate treatment of patients is not~     well defined. For this reason, the investigators aimed to analyze the clinical manifestations~     of retroperitoneal hematomas in a single center using a case-control study design, to analyze~     the treatment procedure determinants and consequently to provide an updated and usable~     treatment algorithm.~   "
42833|NCT03006107|"~     to evaluate the effect of a single intraligamentary injection of piroxicam on postoperative~     pain associated with endodontic procedures.~   "
42834|NCT03006094|"~     The aim of the present study is to investigate and report on the psychometric properties of a~     Greek version of the Chronic Pain Grade Questionnaire (CPGQ).~   "
42835|NCT03006081|"~     Retinal nonperfusion drives vision-threatening complications such as pathological~     neovascularization, which can lead to neovascular glaucoma, vitreous hemorrhage, or~     tractional retinal detachments and macular edema in diabetic retinopathy. Thus, decreasing~     nonperfusion area with aid of anti-VEGF agents might be a useful way to prevent deteriorating~     course of diabetic retinopathy. The main purpose of this study is to determine the efficacy~     of intravitreal aflibercept injection in improvement of retinal nonperfusion and identify~     associated factors in patients with nonproliferative diabetic retinopathy with moderate~     retinal nonperfusion.~   "
42836|NCT03006068|"~     This study is designed to evaluate the long-term safety and efficacy of ABT-494 in~     participants with ulcerative colitis (UC) who have not responded at the end of the induction~     period in Study M14-234 (Substudies 1 and 2), who have had loss of response during the~     maintenance period of Study M14-234 (Substudy 3), or who have successfully completed Study~     M14-234.~   "
42837|NCT03006055|"~     The GILUPI CellCollector® is the first in vivo CTC isolation product worldwide which is CE~     approved. Application data of CellCollector in China is not available now. The purpose of~     this clinical trial is to confirm the validation and safety of CellCollector in Chinese~     patients.~   "
42838|NCT03006042|"~     The transversus abdominis plane block (TAP block) is an effective method of postoperative~     pain management after cesarean section (C-section). Up to now, there are no data available~     about bupivacaine (BPV) plasma levels after TAP block in adults. In the current study, the~     investigators aimed to assess BPV pharmacokinetic parameters after ultrasound-guided TAP~     block using BPV in parturients undergoing C-section and to report its effects on corrected QT~     interval.~   "
42839|NCT03006029|"~     The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended~     Phase 2 dose of TAB08 when administered intravenously (i.v.) to patients with advanced solid~     malignancies.~   "
42840|NCT03006016|"~     Hepatomegaly is common in the morbidly obese patients and it may hamper the access to the~     hiatal region during bariatric surgery. The doctors made a preliminary prospective study that~     showed that a preoperative 4-week course of 1.500 Mg/ day without caloric restriction~     resulted in a 20 % reduction in the volume of the left liver lobe (segment 2 and 3) on~     ultrasounds.~      The aim of this study is to determine whether a 4-week preoperative course with omega-3~     without caloric restriction (1650 mg of omega-3 / day for 4 weeks) may reduce liver volume~     and its fat content, rendering thus surgery easier.~      The primary end point is the reduction of the volume of the left liver lobe as measured by~     magnetic resonance imaging.~      Secondary end points are: the reduction of the whole liver volume, liver steatosis, liver~     injuries during surgery, and duration of surgery, the evolution of liver tests as well as the~     correlation between preoperative MRI data and intraoperative liver biopsy for the~     quantification of liver steatosis.~      Study design: This is an interventional, prospective, multicentric, randomized, double~     blinded clinical trial. Morbidly obese patients with metabolic syndrome candidate to~     bariatric surgery fulfilling criteria for bariatric surgery as established by the Haute~     Autorité de Santé are elegible for the study. Number of subjects to be enrolled: 44 patients~     in 12 months.~      Study time schedule: At the time of the enrollment visit two visits are scheduled, the first~     before the beginning of the study and the last at the end. Surgery is scheduled no more than~     7 days after the end of the treatment. At time of these two visits a clinical examination is~     performed avec calculation of the BMI, blood tests (ASAT, ALAT; GGT, total, HDL and LDL~     cholesterol, triglycerides, glycemia, C-peptide, HbA1c, insulin, HOMA-IR, C reactive protein)~     and a MRI to evaluate the volume and the fat content of the liver. At time of surgery~     duration of surgery and any eventual liver injury are recorded and a liver biopsy is~     performed.~      The hypothesis is that, as shown by the preliminary study, the omega-3, will result in a~     reduction in the volume of the left liver lobe of 20 %.~      Conclusion: If a 4-week preoperative course of omega-3 without caloric restriction results in~     a significant reduction of liver volume and steatosis before bariatric surgery, it may be~     recommended as a systematic preoperative treatment.~   "
42841|NCT03006003|"~     The study will be conducted to assess the depressive symptoms and related markers in the~     postmenopausal female after anti-osteoporosis treatment.~   "
42842|NCT03005990|"~     This study will explore the long-term effects of exercise training on body composition,~     cardiorespiratory fitness, and energy metabolism in the community-dwelling elderly with sleep~     disturbances~   "
42843|NCT03005977|"~     What test is most sensitive in identifying stress urinary incontinence in women with pelvic~     organ prolapse; urodynamics, cough stress test, or pyridium pad test? The hypothesis states~     that there is a difference between the sensitivity of UDS, pyridium pad test and cough stress~     tests, with UDS being the most sensitive and the gold standard in identifying SUI in patients~     with pelvic organ prolapse.~   "
42844|NCT03005964|"~     To compare the safety and efficacy profiles of AM001 Cream, 7.5% and its vehicle cream in the~     treatment of plaque psoriasis~   "
44449|NCT02984995|"~     This is a Phase 2, multi-center, open-label, single-arm study to evaluate the efficacy,~     safety and pharmacokinetics of quizartinib monotherapy in Japanese subjects with FLT3-ITD~     positive refractory or relapsed acute myeloid leukemia.~   "
42845|NCT03005951|"~     The purpose of this study is to see what effect skipping breakfast versus consuming breakfast~     has on cognitive performance and the hormones responsible for glucose homeostasis in lean and~     obese adolescent males. The subjects will be tested on their ability to maintain attention~     when given several tasks called continuous temporal expectancy tasks (CTET) and~     electrophysiological signals using electroencephalogram (EEG) will be monitored. These two~     study groups will be randomized to one of two orders: (A,B) or (B,A) where A = breakfast~     intervention and B = no breakfast. There will be a washout period of 7 days in between study~     visits.~   "
42846|NCT03005938|"~     The aim of the study is to evaluate a short term influence of the Spinal Manipulation (SM) on~     the wrist muscles spasticity and manual dexterity in children with spastic Cerebral Palsy.~      Effect of SM and imitation of the SM has to be compared in the double-blinded randomized~     clinical trial.~   "
42847|NCT03005925|"~     Rheumatoid arthritis (RA) is the most common inflammatory rheumatism in adults, affecting~     nearly 0.4% of the general population. It is a real public health issue. International~     guidelines recommend strict control (remission or low disease activity) of the disease, to~     avoid joint destruction in order to reduce the functional impact of the disease in the long~     term and to improve the quality of life of the patients.~      This care is based on a close follow-up requiring regular visits with the specialist which~     represents an additional cost (transport, visits). In this context, tele-medicine is often~     proposed as a complementary approach in the management of these chronic patients.~      Thus, the investigators propose to study the interest of a connected device by comparing a~     group of patients using this Smartphone application, coupled with a hand dynamometer during~     the 6 months following initiation of a new DMARD.~   "
42848|NCT03005912|"~     Despite modern hearing aids such as cochlear implants, speech comprehension during telephone~     conversation is challenging for hearing-impaired patients. On the one hand, conventional~     telephones transmit a limited spectrum of the acoustic signal compared to a normal~     conversation. On the other hand, lip reading during a phone call is generally not possible.~     As a result, speech comprehension during a telephone conversation is reduced. In previous~     studies, the authors demonstrated an improved speech comprehension for hearing-impaired~     patients using voice-over internet protocol (VoIP) telephony (Skype) compared to conventional~     telephony.~      New bluetooth-enabled hearing aids allow for direct transmission of the telephone signal to~     the hearing device. As the direct transmission is expected to improve signal-to-noise ratio,~     speech comprehension is tested in patients with bluetooth-enabled hearing aids for 4~     different scenarios: 1. conventional telephony without bluetooth device 2. conventional~     telephony with bluetooth device 3. VoIP telephony without bluetooth device 4. VoIP telephony~     with bluetooth device~   "
42849|NCT03005899|"~     This is a Phase 3 clinical trial to compare the safety and efficacy of SyB P-1501 with the~     SyB P-1501 placebo for the management of the first 24 hours of post-operative pain.~   "
42850|NCT03005886|"~     The aim of this study was to evaluate the effects of periodontal treatment on gingival~     crevicular fluid (GCF) levels of Neopterin(N) and vascular cell adhesion molecule (VCAM-1) in~     chronic periodontitis(CP) patients with acute myocardial infarction(AMI) in comparison to~     systemically healthy CP patients. The investigators' hypothesized that severe CP may play a~     role in initiating or exacerbating MI and there is an increased risk for AMI among~     systemically healthy persons affected with severe CP.~   "
42851|NCT03005873|"~     This trial is a Phase IIa, Randomized, Double blinded, Placebo controlled, Dose finding Study~     to investigate the safety and efficacy of TLC599 in subjects with osteoarthritis of the knee.~   "
42852|NCT03005860|"~     Surgery, perioperative stress, anaesthetics and analgesics may modulate the~     immunosurveillance mechanisms and overwhelm host defences that normally maintain a balance~     between immunity & carcinogenesis. This may lead to escape of cancer cells and tilt the~     scales toward a more protumorigenic microenvironment. Volatile agents, in particular, have~     been shown to exhibit profound immunosuppressive effects. In comparison, propofol has a~     favorable profile and inhibits cancer cell activity. Determining cancer-protective role of~     TIVA with propofol presents an exciting window of opportunity that has potential to improve~     outcomes in cancer patients undergoing resection surgery~   "
42853|NCT03005847|"~     Fermented papaya preparation has been reported to bind and neutralize reactive oxygen species~     as well as iron. Patients undergoing hemodialysis are generally on iron overload status due~     to their inability to use iron storage adequately. The aim of this study is to evaluate the~     effect of FPP on the iron status of these patients.~   "
42854|NCT03005834|"~     Because of the genetic and traditional commonalities between the underlying causes of~     atherosclerotic cardiovascular diseases (CVD) and cancers, we hypothesized that patients with~     atherosclerotic CVD may have a high incidence of cancers when compared with those with~     non-atherosclerotic CVD. To address this hypothesis, we investigated longitudinal clinical~     outcomes in a total of 32,095 consecutive patients with CVD enrolled in the Sakakibara Health~     Integrative Profile (SHIP) cohort study which was launched in 2006 for the purpose of~     improving healthy life expectancy in patients with CVD in our institute.~   "
42855|NCT03005821|"~     The purpose of this study is to evaluate the efficacy of Chinese pediatric massage as an~     add-on therapy while comparing with sham massage both on the basis of usual care for 0-6~     years old children with acute diarrhea.~   "
42856|NCT03005808|"~     Blockage of the transverse abdomen (TAP) promotes excellent analgesia of the abdominal wall~     and the parietal peritoneum. The TAP block could advange the postoperative pain of~     Appendectomy in children. The world literature doesn´t focus the best Ropivacaine´s~     concentration to improve postoperative pain in Appendectomy in children. We propose a~     randomized trial that compares 3 groups children submitted Appendectomy in children between 6~     and 16 years. The control group has received no blockade, the other two groups have received~     TAP blocks if ropivacaine 0,25% and 0,5% 0.4ml/kg.~   "
42857|NCT03005795|"~     To assess the effect of music during colposcopy on women´s anxiety.~   "
42858|NCT03005782|"~     The primary objectives in the dose escalation phase are to evaluate safety and~     pharmacokinetics (PK) in order to determine a recommended phase 2 dose (RP2D) of REGN3767 as~     monotherapy and in combination with REGN2810 in patients with advanced malignancies,~     including lymphoma. The primary objectives in the dose expansion phase are to assess~     preliminary anti-tumor activity of REGN3767 alone and in combination with REGN2810~     (separately by cohort) as measured by objective response rate (ORR).~   "
42859|NCT03005769|"~     This is an observational, retrospective, non-interventional study that will include~     schizophrenic patients who were initiated with aripiprazole once-monthly as per normal~     clinical practice at least 6 months before the data collection starts (inclusion visit), and~     is designed to evaluate demographic and clinical predictors of persistence with this~     treatment.~      Data from each patient will be collected after informed consent is signed (inclusion visit),~     and will include retrospective information from the start of aripiprazole once-monthly~     treatment initiation (index date) until the follow-up/inclusion visit (minimum of 6 months~     after the index date). Data will be retrospectively collected from all visits occurring as~     per clinical practice (usually once monthly).~   "
42860|NCT03005756|"~     The needle guiding robot helps targeting of radiofrequency ablation needles by matching~     computed tomography images and patients' bodies. Actual insertion of needles will be~     performed by doctors. This study evaluates the safety and efficacy of needle targeting on~     patients with hepatocellular carcinoma.~   "
42861|NCT03005743|"~     Purpose of the study is to determine whether Image based brachytherapy is superior in terms~     of local control to Conventional radiograph based brachytherapy in locally advanced cervical~     cancers in a Phase III randomized setting.~   "
42862|NCT03005730|"~     Background: According to the International Association for the Study of Pain (IASP), the term~     temporomandibular disorder (TMD) regards a subgroup of orofacial pain, the symptoms of which~     include pain or discomfort in the temporomandibular joint, ears, masticatory muscles and neck~     on one or both sides as well as joint sounds, limited mandibular movements or mandibular~     deviation and difficulties chewing. Phototherapy, such as low level laser therapy (LLLT) and~     light-emitting diode (LED) therapy, is one of the resources used to treatment muscle pain.~     Thus, there is a need to investigate therapeutic resources that combine different wavelengths~     as well as different light sources (LLLT and LED) in the same apparatus.~      Question: The aim of the proposed study is to evaluate the effects of phototherapy on pain,~     activity of the masticatory muscles (masseter and anterior temporal bilaterally) and joint~     mobility in individuals with temporomandibular disorder (TMD). A further aim is to determine~     the cumulative effect 24 and 48 hours after a six session.~      Methods/Design: A placebo-controlled, double-blind, randomized, clinical trial will be~     carried out involving 30 women between 18 and 40 years of age with a diagnosis of myogenous~     TMD. The participants will then be randomly allocated to two groups totaling 15 individuals~     per group. Group 1 submitted to a session of phototherapy with 39,27 Joules per point one~     group will receive placebo therapy (0 Joules). The following assessment tools will be~     administered on four separate occasions (baseline and immediately after, 24 h after and 48 h~     after phototherapy). Pain intensity will be assessed using the visual analog scale for pain,~     meter for range of movement, and electromyographic EMG analysis on the masseter and anterior~     temporal muscles.~      Discussion: The study will support the practice of evidence-based to the use of phototherapy~     in individuals with a myogenous TMD. Data will be published after the study is completed.~   "
42863|NCT03005717|"~     Study LIPO-202-CL-31 is a multi center, randomized, double-blind, placebo-controlled study to~     evaluate the safety and efficacy of two different doses of LIPO-202 versus placebo on~     submental bulging due to subcutaneous fat. Approximately 150 participants of either gender~     who have a Moderate Bulge or Large Bulge in the submental fat (on Patient-Reported~     Submental Bulging Scale [PR-SBS] and Clinician-Reported Submental Bulging Scale [CR-SBS])~     will be recruited for this study.~   "
42864|NCT03005704|"~     The specific objective of this study is to investigate the potential for normal platelets to~     reverse the inhibition of platelet aggregation in patients treated with ticagrelor in~     combination with aspirin.~   "
42865|NCT03005691|"~     The purpose of this study is to determine whether the metabolite concentrations within the~     anterior cingulate cortex and periaqueductal gray matter predict the intensity and~     interference of neuropathic pain after the development of chronic whiplash syndrome.~   "
42866|NCT03005678|"~     A randomized controlled trial to compare for the efficacy and tolerability of denosumab and~     oral alendronate in the management of glucocorticoid induced osteoporosis~   "
42867|NCT03005665|"~     The purpose of the trial is to study the effect of acetazolamide administered via Ryle's tube~     on optic nerve sheath diameter in laparoscopic live donor nephrectomy patients.~   "
42868|NCT03005652|"~     The European Commission Horizon 2020 programme has funded the SCD-WELL trial to investigate~     the efficacy of mindfulness-based training to reduce anxiety in individuals with Subjective~     Cognitive Decline (SCD), in comparison to an active comparison condition.~      It is increasingly recognized that most neuropathological processes start years before the~     onset of clinical Alzheimer's disease (AD). Hence, there is a growing urgency to target~     individuals in the earliest stages for intervention when neurodegeneration is still limited.~     Individuals clinically judged to have SCD, defined by subjectively experienced cognitive~     decline but normal performance on cognitive tests, are at increased risk for future cognitive~     decline and AD. These individuals with SCD currently have no established treatment options.~     Symptoms of anxiety have high prevalence in this population, and evidence from recent~     longitudinal research links anxiety with significantly accelerated cognitive decline in at~     risk individuals. Effectively reducing anxiety in this population may therefore not only~     relieve participants from burdensome symptoms, but may also slow cognitive decline and delay~     or prevent the onset of AD.~      The investigators chose to study the efficacy of a mindfulness-based intervention to reduce~     anxiety in this population because this type of intervention has been shown to reduce anxiety~     in a number of populations, including in older adults. Further, accumulating evidence~     indicates that intensive mindfulness training effectively down-regulates a number of other~     adverse psychological and biological risk factors for AD, such as stress, depression,~     insomnia, feelings of loneliness and social exclusion, and cardiovascular risk factors. These~     findings are relevant to AD because approximately a third of AD cases worldwide might be~     attributable to potentially modifiable risk factors. In spite of the increased use of~     mindfulness-based interventions to treat clinical symptoms, these trials often suffer from~     the lack of an adequate comparison condition and lack of follow up to know whether initial~     benefits are maintained.~      SCD-WELL includes both an active comparison condition and a 16-week follow up assessment~     after the end of the intervention. SCD-WELL is a non-CTIMP European multicentre,~     observer-blinded, randomized, controlled, superiority trial with two parallel groups, which~     compares anxiety and additional behavioural and biological outcomes amongst people with SCD~     who receive mindfulness-based training and those who receive a health education comparison~     intervention. Outcomes will be measured at baseline, post-intervention and 16 weeks after the~     end of the intervention.~      160 older-adult patients diagnosed with SCD will be recruited to the study from memory~     clinics at four sites in Europe: London, UK; Cologne, Germany; Barcelona, Spain; Lyon, France~     where they will have sought help due to concern about their memory. Participants will be~     recruited in two waves over a maximum two-year period and will be provided with a participant~     information sheet, and asked to consider their participation. Should they wish to~     participate, and after a signed and dated Informed Consent Form has been obtained, a unique~     participant identification (ID) will be assigned to the participant.~      Behavioural assessments will take place at baseline, after the intervention, and 16 weeks~     after the end of the intervention. Because we believe that mindfulness-based training has the~     potential to affect a number of areas of life we will also look at changes in other areas of~     psycho-affective symptoms, social functioning, awareness, well being and quality of life,~     sleep quality, and cognition, after the intervention and 16 weeks after the end of the~     intervention. Validated neuropsychological tests and behavioural questionnaires were selected~     for their sensitivity to the domains listed above. These measures will be completed alone by~     the participant or in the presence of a psychometrist. Questionnaires will also be completed~     by partners at the three time points to coincide with assessments of participants.~      Blood samples will be taken at the memory clinic by certified phlebotomists at baseline,~     after the intervention and during follow-up to measure genetic markers of risk for AD as well~     as proteomic markers of stress and AD that may be affected by this intervention. Information~     will also be collected about the medical care of the participant.~      Trained facilitators will deliver both interventions. Both interventions follow a manual, are~     group-based, include at-home activities, and are 8 weeks in duration. Both interventions~     provide individuals with sustainable skills that remain beyond the intervention period.~   "
42869|NCT03005639|"~     Neoadjuvant Vemurafenib and Cobimetinib in BRAF V600 Mutant Stage IIIB-C Melanoma~      • To evaluate the overall radiological complete response rate in patients with stage IIIB/C~     melanoma after 8 weeks of neoadjuvant vemurafenib and cobimetinib~   "
42870|NCT03005626|"~     We aim to measure the impact of a transition program in congenital cardiology in terms of~     health-related quality of life.~   "
42871|NCT03005613|"~     A Prospective, Randomized Comparison of Efficacy and Effect on Quality of Life Between~     Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation.~   "
42872|NCT03005600|"~     Hyperglycaemia in Pregnancy or Gestational Diabetes Mellitus (GDM) is one of the most common~     obstetric medical conditions which when undetected can cause significant adverse outcomes for~     the mother and the offspring. Diagnosis is typically made between 24-28 weeks of pregnancy~     using oral glucose tolerance test (OGTT). Therefore, some damage might have already happened~     prior to detection. Although universal screening is recommended by many guidelines, this is~     not uniformly followed across the world, partly because of doubts about cost-effectiveness.~     Only selective screening is followed based on presence of at least one of the high risk~     factors (age, BMI, previous history, etc). This strategy can miss up to 50% of GDM. In~     addition, no data exists in India and Kenya. In low and middle-income countries (LMICs),~     where majority live in rural settings, the major limitations are difficulty in conducting~     OGTT, which requires prompt access to laboratory facilities. Combining the clinical and~     easily analysable biochemical markers (composite risk score) could improve the prediction and~     if proven, could help to prevent the onset of GDM. Fasting glucose levels (at non-diabetes~     levels) in early pregnancy could predict future GDM. HbA1c in early pregnancy can be a better~     marker as it can be done point-of-care and does not require patients to be in a fasting~     state. The overall objective of the proposed project is to develop a composite risk score to~     predict GDM in early pregnancy using a combination of easily identifiable risk factors such~     as age, BMI, family history of Type 2 Diabetes along with HbA1c in Indians and Kenyans. The~     project will recruit pregnant women in early pregnancy from South India (n=3400) and Western~     Kenya (n=4000). Contribution of individual risk factors as well as the composite risk score~     on the risk of developing GDM will be assessed. Detailed health economic analyses will enable~     policy makers to make informed decision based on local data.~   "
42873|NCT03005587|"~     This a prospective observational study in Chronic Liver Disease patients admitted or seen in~     OPD, Department of Hepatology, Institute of Liver and Biliary Sciences, India. The study will~     be conducted in a period of three months starting September 2016 in sample size of 80 . A~     detailed proforma including history and examination and routine blood investigations will be~     noted. The patients will undergo close follow up at 0, 7, 15, 30, 45, 60, 90 days and similar~     activities will be repeated at every visit.~   "
43396|NCT02998775|"~     E7080-A001-010 is a multicenter, parallel-group study in participants with mild, moderate, or~     severe hepatic or renal impairment and age-, gender-, and smoking status-matched healthy~     participants. The primary objective of the study is to obtain plasma from participants for~     use in in vitro protein binding studies.~   "
42874|NCT03005574|"~     The purpose of this study is to determine if using a tablet computer, which is a very small,~     easy-to-carry computer, to practice thinking exercises at home will help improve your~     attention, memory, and problem solving abilities. All the participants will receive training~     in the thinking skills for work program. But in order to determine the effect of tablet use~     for home practice, half of the participants will be given a tablet to practice the thinking~     exercises at home. All participants will be receiving vocational rehabilitation and have a~     goal of getting a job.~   "
42875|NCT03005561|"~     In the last 50 years the use of growth hormone (rhGH, somatropin) has become commonly to~     treat problems such as GH deficiency, chronic renal failure and Turner syndrome and~     Prader-Willi. Giving the hormone in childhood and adolescence is designed to accelerate~     growth to close the gap in the average population and reach a final height is normal, while~     minimizing risks and costs.~      Noncompliance to treatment with GH is common; Other estimates are that one third to one half~     of patients do not comply with the provisions as require. This may result in linear growth~     depreciation, unnecessary diagnostic tests, unnecessary change of dosage and treatment and~     higher costs.~      Many studies have been devoted to locating factors make it difficult to adhere to their~     chronic diseases in children, including conditions that require treatment with GH.~      Pain is the primary cause for difficulties. In recent decades, many resources were devoted to~     research and development of ways of dealing with pain in all aspects.~      In order to implement all of the information collected, appropriate interventions medium~     should be found; In this study we intend to use the method of playback. Playback define that~     improvisation as a theater facilitator asks the audience to share moments, feelings and~     stories of his daily life, and a group of actors improvise their stories in front of the~     stage as a kind of play-back. Unlike hobbies such as sports or singing, the method allows~     not only to unload the tensions but also communication and collaboration. It is very~     reminiscent of psychodrama, but unlike, is not considered a therapeutic tool.~      Assumption:~      Intervention of two playback meetings during the year will uncover the difficulties and~     engage ways of dealing with pain. That will reduce the difficulties caused by GH injections~     and improve compliance to treatment.~   "
42876|NCT03005548|"~     The primary objective of this single center, prospective, randomized, double blind clinical~     trial is to evaluate the effectiveness of anodal transcranial direct current stimulation~     (tDCS) combined with patient controlled analgesia (PCA) morphine, on intravenous morphine use~     for postoperative analgesia after thoracotomy. The intervention group will receive treatment~     with anodal tDCS, whereas the control group will receive sham stimulation.~   "
42877|NCT03005535|"~     This will be a randomized clinical trial carried out on subjects with suboptimal control of~     cholesterolemia who will consume 30 g per day of a vitaminized corn oil (plus B6 and E~     vitamins), in order to evaluate the effects on lipid profile, endothelial function and PCSK9~   "
42878|NCT03005522|"~     An individual's quality of life can be seriously affected by the severity of dental pain. The~     emergency department is a common place to find those seeking relief from their dental pain-~     often times seeking removal of the affected tooth, dental anesthetic injections or oral pain~     medications. There are a number of dental infections that cause this type of debilitating~     pain. One such dental infection is termed periapical abscess. This infection involves the~     tooth pulp. These infections can arise in three ways: introduction through a defect in the~     enamel and dentin; from a periodontal pocket or an adjacent tooth; or hematogenous seeding of~     the pulp from mechanical irritation. As this disease process continues there are a number of~     complications including chronic pain and, more seriously, the spread of infection into deep~     spaces which can be a life threatening condition.~      The Emergency Department treatment of this infection includes pain control, antibiotics and~     dental referral for ultimate management of the infection.~      The purpose of our study is to investigate whether the addition of oral steroids will alter~     the time until patient experiences improvement in their dental pain. Steroids are a commonly~     used anti-inflammatory that is used in the Emergency Departmentfor the purpose of pain relief~     from throat pain. As the pain from periapical infection is thought to be largely from the~     pressure we speculate that the anti-inflammatory effects of steroids may decrease the~     inflammation thus the pressure and may ultimately lead to a decrease in time until the~     patient experiences some relief from their pain.~   "
42879|NCT03005509|"~     A prospective before-and-after study to evaluate the effect of implementing a Trauma Quality~     Improvement protocol on the process of Trauma Quality Improvement meetings and major trauma~     patient outcomes at four trauma centres in India.~   "
42880|NCT03005496|"~     This study is a controlled trial which compares the effect of zinc, beta-carotene, and~     Vitamin D3 supplementation in pregnant women which has preterm birth. The measured outcome is~     zinc, vitamin A, and 25(OH)D level in serum and placenta, MyD88, TRIF, NFκB, and IL-1β levels~     in placenta.~   "
42881|NCT03005483|"~     This study is a clinical trial, prospective, randomized and double-blinded. Gabapentin oral~     10 mg/kg was administered to reduce the pain intensity as well as the opioid consumption in~     children from 3 months to 16 years submitted unilateral limb surgery.~   "
42882|NCT03005470|"~     National and international guidelines that guide evidence-based clinical practice advocate an~     effort to improve blood pressure control based on changing lifestyle and use of blood~     pressure lowering medication. However, the effectiveness of the approach usually depends on~     patient adherence to both types of interventions - pharmacological and behavioral. Lack of~     success on blood pressure control has increased the scope of interventions to improve~     adherence and to reduce cardiovascular risk factors without overburdening the public health~     system. The use of technologies - mobile or smart phones, games, blogs, internet and video~     conferencing - to implement interventions can reduce costs and increase coverage.~      Interactive interventions have been associated with a reduction in systolic blood pressure of~     3-8 mmHg in patients with hypertension. These interventions were individually tailored to~     patient specificities and involved self-monitoring of blood pressure and lifestyle changes,~     including regular physical activity, DASH diet, restriction of dietary salt intake, and~     weight control. However, the effectiviness of these interventions may have short half-lives~     without periodic reinforcement, either to adhere to pharmacological treatment or behavioral~     changes. Innovative technologies can be used to achieve lasting effect and even greater blood~     pressure reduction.~      Therefore, the purpose of this study is to compare effectiveness of four strategies to reduce~     blood pressure and improve lifestyle.~   "
42909|NCT03005119|"~     To evaluate the safety and tolerability of oral administration of PTL201 for relief of~     spasticity-related symptoms in 70 MS patients and to evaluate the efficacy of oral~     administration of PTL201 in relief of spasticity-related symptoms in MS patients. The~     pharmacokinetics of PTL201 in comparison to buccally administered Sativex will be evaluated~     in sub-study prior to the efficacy study.~   "
42883|NCT03005457|"~     Pilot study to assess the feasibility and initial efficacy of therapist-as-consultant,~     game-based CI therapy. Pre/post study design. Participant received a target of 30 hours~     game-based motor intervention, 100 hours constraint of the less affected upper extremity, and~     5 hours therapist consultation (including completion of a behavioral contract at the first~     study visit). Duration of intervention was 10 consecutive weekdays, with pre-treatment and~     post-treatment testing performed within 1 week prior to and 1 week post-intervention by an~     independent tester.~   "
42884|NCT03005444|"~     Liver cirrhosis has traditionally been seen as a state of hypocoagulability and can be~     protected against thrombosis. However, recent studies have completely changed this paradigm.~     Patients with liver cirrhosis have an impaired hepatic synthesis of procoagulation factors~     but also anticoagulation factors, which is associated with an increase in other procoagulant~     factors such as factor VIII and von Willebrand factor which determines an elevated thrombin~     generation and, ultimately, a hypercoagulability state. Several consequences of~     hypercoagulability can be expected, such as portal vein thrombosis and venous~     thromboembolism. In addition to the potential direct deleterious consequences for the~     development of portal vein thrombosis, recent data have shown a close relationship between~     the activation of coagulation and faster progression of liver fibrosis.~      Bacterial translocation is a common problem and plays an important role in the pathogenesis~     and complications in patients with decompensated cirrhosis, including infections as well as~     hepatic encephalopathy and hepatorenal syndrome. To date, several biomarkers of BT have been~     proposed, which include bacterial DNA, soluble CD14, lipopolysaccharides endotoxin,~     lipopolysaccharide-binding protein, calprotectin and procalcitonin. Besides, endotoxemia and~     activation of the TNFa-pathway may be also considered key components in the pathogenesis and~     aggravation of portal hypertension and its complications.~      Anticoagulation therapy has a beneficial effect on survival in patients with idiopathic~     pulmonary fibrosis. Besides, a pilot study showed that the use of anticoagulants warfarin for~     8 weeks improved the liver elasticity determined by Fibroscan® (Dhar A, et al. J Hepatology~     2012. Abstract). An ongoing study of warfarin for the prevention of fibrosis due to recurrent~     hepatitis C should also contribute to an understanding of the role of the haemostatic system~     and fibrosis (http: //www.controledtrials.com/IRSCTN12504151).~      On the other hand, a recent prospective study in a group of 70 patients with liver cirrhosis~     (Child B and C stages up to 10 points) who were randomized to receive enoxaparin for a year~     (n = 34) vs no intervention (n = 36) showed that anticoagulant treatment with enoxaparin is~     safe and effective, significantly reducing risk of PVT development and liver decompensation,~     markedly improving overall survival. This study provides exciting preliminary data regarding~     the potential use of prophylactic anticoagulation in improving clinical outcomes in~     cirrhosis, beyond the prevention of portal vein thrombosis. This study suggested that the~     effect was partly due to a direct effect of reducing BT and levels of proinflammatory~     cytokines. However, this study included few patients, was not double blind, and did not have~     a placebo group. Therefore, despite the spectacular results, the use of prophylactic~     anticoagulant therapy has not become routine practice in patients with cirrhosis and more~     studies are needed to assess the potential usefulness of anticoagulation in improving the~     prognosis of liver cirrhosis.~      Transjugular intrahepatic portosystemic shunts (TIPS) are now routinely used to treat the~     complications of portal hypertension, such as variceal bleeding and refractory ascites. TIPS~     is the most effective method to prevent rebleeding, however, it is burdened with increased~     risk of hepatic encephalopathy and deterioration of liver function in patients with advanced~     cirrhosis. Notably, TIPS can not only relieve portal pressure but also can redirect the~     portal blood flow through the shunt directly into the systemic circulation which can cause~     systemic hemodynamic changes.~      Given the preliminary data suggesting a beneficial effect of prophylactic anticoagulation~     with LMWH in cirrhotic patients, this multicenter randomized controlled study attempts to~     demonstrate the effect of long term LMWH therapy after TIPS on survival in cirrhotic patients~     with variceal bleeding.~   "
42885|NCT03005431|"~     Manitoba parents of preschool children newly diagnosed with Autism must wait up to a year to~     receive government funded services for their child. During this delay parents need support~     and training to promote their child's development. The purpose of this research is to develop~     and evaluate an on-line, parent training and support program that will assist parents during~     this time. It is predicted that if parents receive on-line training and support they will~     increase their parenting knowledge and skills, reduce their stress, and create better~     outcomes for their child, in comparison to parents who do not receive the training. The~     experimental study (n=60) will use a randomized, masked, waitlist control design that~     compares a treatment group to a control group. Descriptive statistics will be used to~     describe differences between groups, ANCOVA's to test for differences between groups, and~     Pearson correlations to describe the relationship between parent stress and outcomes.~   "
42886|NCT03005418|"~     This study evaluates the use of the Human Acellular Vessel (HAV) in adults with arterial~     trauma in the lower limb who are undergoing vascular reconstructive surgery. All subjects~     will be implanted with a HAV as an interposition vessel or bypass using standard vascular~     surgical techniques. There is no control arm.~   "
42887|NCT03005405|"~     This protocol aims to assess the cost-efficacy and applicability of the treatment of lesions~     moderate caries using sealants as an alternative to the restorations on occlusal surfaces of~     deciduous teeth. Initially, a non-inferiority study was designed in order to verify if~     sealing could be non-inferior than restoration. In this case, it could be preferable since it~     is less invasive. Therefore, cost will be put forward into the analysis considering even~     reintervention during the follow-ups (cost-efficacy analyses). Finally, the acceptability~     could be another differential point between treatments.~   "
42888|NCT03005392|"~     -  Exercise programs in children and teenagers with Acute Lymphoblastic Leukemia (ALL)~          strengthens their physical fitness.~        -  Exercising improves muscular and functional mobility fitness after finalizing~          chemotherapy in children and teenagers diagnosed with ALL.~        -  Assess cardiological changes~   "
42889|NCT03005379|"~     The purpose of this study is to determine whether Fecal Microbiota Therapy (FMT) is effective~     vs. placebo in the prevention of C. difficile infection recurrence.~   "
42890|NCT03005366|"~     -  The main objective of this project is to study the efficacy and the mechanistic value of~          blocking both atrial specific and atria-preferential dynamics of ionic currents to~          terminate paroxysmal atrial fibrillation (AF).~        -  The hypothesis is that a drug blocking atrial specific and atria-preferential dynamics~          of ionic currents (IK,ACh - acetylcholine sensitive K+ current - and INa - inward sodium~          current - , respectively) will be more effective to terminate paroxysmal AF episodes~          with fast atrial activation rates, than a classical INa blocker, which will be more~          effective to terminate AF episodes with slower activation rates.~        -  The investigators will include patients without structural heart disease and~          short-lasting AF episodes (<48 h.). Double blind and single center study, in which~          patients will be randomly assigned to a cardioversion group using intravenous flecainide~          or to an atria-preferential and atrial-specific blockade group using intravenous~          vernakalant. Patients will be routinely monitored in the electrophysiology room to~          acquire both 12-lead digitized ECG signals and non-invasive body surface potential~          mapping. Atrial signals will be extracted from both the multisite body surface and ECG~          recordings to obtain temporal and spectral parameters, and measure organization and~          atrial rate in both groups. The results obtained in the clinical setting will be studied~          in mathematical models to understand their capability to terminate paroxysmal AF. The~          project expects to provide consistent, reliable and reproducible parameters that will~          assist clinicians to know what type of paroxysmal AF episodes will be more suitable to~          effectively terminate, upon administration of drugs with an atrial specific and~          atria-preferential profile.~   "
42891|NCT03005353|"~     Fungal infections have increased over the last two decades, largely because of the increasing~     size of the population at risk, including patients who are immunocompromised, broad-spectrum~     antibiotics and intravascular catheter users. Essential oils and other extracts of plants~     have evoked interest as sources of natural products. They have been shown to possess~     antibacterial, antifungal, antiviral, insecticidal and antioxidant properties. To the best of~     our knowledge, no study has examined the efficacy of cumin seed extract on relieving~     vulvovaginal candidiasis in vivo.~   "
42892|NCT03005340|"~     Randomized, open-label, single-dose, three-treatment, six-sequence, three-way crossover study~     to evaluate the safety and pharmacokinetic characteristics after coadministration of C1-R215~     and C2-R215 compared to the administration of C1-R215 and C2-R215 independently in healthy~     male volunteers~   "
42893|NCT03005327|"~     The overall objective is to evaluate X4P-001 in the treatment of patients with WHIM Syndrome.~   "
42894|NCT03005314|"~     Esophageal carcinoma is a common digestive system tumor, with number of deaths ranking No. 4~     in malignant tumors. Esophageal squamous cell carcinoma in stage Ⅱ, III is the most common in~     China. The esophageal cancer during these stages is no longer localized lesions, and cancer~     will be transferred to other organs of the body through blood transmission, leading to tumor~     metastasis, which is the main cause of the patients' death. The tumor cells invade the~     surrounding tissues of primary tumor cells and enter the blood and lymphatic system, thus the~     circulating tumor cells (CTC) is formed and transported to a distal tissue, then effusing,~     adapting to the new microenvironment and finally forming metastases through the process of~     seeding, proliferation and colonization.~      Recently, the controversy of surgical treatment of esophageal carcinoma is concentrated on~     the neoadjuvant therapy during perioperative period. NCCN guideline of 2015 recommended that~     patients with esophageal squamous cell carcinoma in T1b, N + and T2-T4a, N0-N + may consider~     preoperative neoadjuvant therapy, but its supporting literature (David Cunningham 2006, Marc~     Ychou 2011 and P. van Hagen, 2013) includes patients with pathology of the type~     adenocarcinoma. The esophageal cancer treatment guidelines of Japan 2015 adopted the opinion~     of NCCN Guidelines, and recommended neoadjuvant chemotherapy and radical surgery as the~     standard treatment for stage II and III esophageal cancer patients based on the results of~     randomized controlled clinical trial JCOG9907. However, the guidelines also pointed out that~     the role of neoadjuvant chemotherapy for resectable T1-3N0-1M0 cancers remains unclear~     according to the results of some meta-analysis.~      The investigators choose the detection of peripheral venous blood CTCs and the disease-free~     survival as the main index, to compare the treatment effect of patients, those received~     neoadjuvant therapy, surgery and those received directly surgery, postoperative chemotherapy~     with esophageal squamous cell carcinoma in stage Ⅱ, III by means of evidence-based medicine;~     Define the indication of neoadjuvant chemotherapy in the treatment of esophageal squamous~     cell carcinoma in stage Ⅱ, III; Draft the solution to evaluate the treatment effect of~     neoadjuvant chemotherapy to esophageal cancer in stage Ⅱ, III, and the indication of~     neoadjuvant chemotherapy by test the peripheral venous blood CTCs and join the Chinese~     clinical guideline.~   "
42895|NCT03005301|"~     The present study is a prospective, two-center, randomized, controlled, open-label,~     non-inferiority trial evaluating the efficacy and safety of a new intelligent~     electroacupuncture instrument in treating neck pain caused by cervical spondylosis.~   "
42897|NCT03005275|"~     In polycystic ovary syndrome (PCOS) patients, both in vitro maturation (IVM) and~     intra-cytoplasmic sperm injection (ICSI) are indicated as optional treatments. Although~     recently ICSI techniques have been reported as more successful the IVM in achieving~     pregnancy, they have also become much more expensive for the couples involved. Whilst most~     high-income countries offer Assisted Reproductive Technology (ART) procedures fully or~     partially paid by the government, the patients in low or middle-income countries have to~     cover self-fund infertility treatments. With limited resource, a study conducting based on~     the prevalence - based cost - effectiveness analysis is necessary for health managers, policy~     makers and especially to assist patients' decision making in these countries.~      However, there are still limited published studies that have evaluated the cost-effectiveness~     of these strategies are available in the literature. This study is conducted based on the~     prevalence - based cost - effectiveness analysis from the patient's perspective. Activity -~     based costing method is used to cost in all levels of the healthcare system, which the~     patients have to pay directly or indirectly. It also analyses incremental cost -~     effectiveness to evaluate the cost - effectiveness of IVM and ICSI in PCOS women.~   "
42898|NCT03005262|"~     To allow a patient continued access to MLN8237~   "
42899|NCT03005249|"~     To evaluate the safety and efficacy of neural stem cells (NSCs) therapy for cerebral palsy.~   "
42900|NCT03005236|"~     The proportion of elderly patients with end-stage kidney disease undergoing renal replacement~     therapy (RRT) is steadily increasing. Although kidney transplantation remains the optimal RRT~     of choice, it is clear that older adults have a differential risk versus benefit profile~     after kidney transplantation compared to younger adults. No age-adapted immunosuppression for~     older adults has been shown to improve kidney allograft outcomes but recent sub-analyses of~     clinical trial data has hinted at improved outcomes for older kidney transplant patients~     receiving Envarsus versus standard twice-daily tacrolimus formulations. This feasibility~     study will investigate this effect to see whether a full scale randomised controlled trial is~     warranted and to provide information regarding study feasibility.~   "
42901|NCT03005223|"~     A randomized, open label, crossover study to explore drug-drug interactions between DWC20155~     / DWC20156 and DWC20163 in Healthy Volunteers~   "
42902|NCT03005210|"~     Comparative randomized, single dose, three way three sequence two treatment partial replicate~     crossover open-label study to determine the bioequivalence of Sofosbuvir and Ledipasvir from~     Magicbuvir Plus 90/400 mg Tablets (Magic Pharma, Egypt) Versus Harvoni 90/400 mg Tablets~     (Gilead Sciences, Canada) in Healthy Human Volunteers Under Fed Condition.~   "
42903|NCT03005197|"~     Teeth injuries are considered one of the most challenging events that occur in dentistry,~     especially in children. After an injury, there is a possibility that the blood supply to the~     tooth may become affected and compromised leading to nerve and blood vessels death with the~     tooth described as a non-vital tooth.~      The conventional diagnostic tools available to assess tooth nerve/blood supply are not always~     reliable. Child cooperation and understanding contribute greatly to this shortfall. Failure~     to assess the vitality of the tooth may result in pain, swelling or infection of the tooth or~     de-vitalising a normal tooth which may render the tooth weak for the future and possibly~     losing the tooth.~      The laser Doppler flowmetry is a non-invasive, non-painful technique and shown to be more~     reliable than the traditional techniques. We aim to assess if this device can predict and~     assess whether the tooth is alive or dead during the follow up visits of the injury along the~     other conventional tests.~   "
42904|NCT03005184|"~     This study tests the hypothesis that endogenous bradykinin contributes to effects of a~     combined angiotensin receptor blocker/neprilysin inhibitor (LCZ696 or Entresto)~   "
42905|NCT03005171|"~     The study evaluates the efficacy of intravenous lidocaine as an analgesic modality in~     patients undergoing open upper abdominal surgery; when compared with thoracic epidural~     analgesia. Half of participants will receive intravenous lidocaine infusion, while the other~     half will receive thoracic epidural bupivacaine infusion.~   "
42906|NCT03005158|"~     Patients with suspected acute coronary syndrome account for a tenth of all presentations to~     the Emergency Department and up to 40 per cent of unplanned hospital admissions. The majority~     of patients do not have a heart attack (myocardial infarction), and may be safely discharged~     from the Emergency Department.~      The investigators propose to evaluate whether the use of the HighSTEACS pathway in patients~     with suspected acute coronary syndrome reduces length of stay and allows more patients to be~     safely discharged from the Emergency Department. This pathways utilizes high-sensitivity~     cardiac troponin I testing and will rule out myocardial infarction if troponin concentrations~     are <5 ng/L on presentation, with further testing indicated at 3 hours only in those~     presenting early or with troponin concentrations between 5 ng/L and the 99th centile.~      In six secondary and tertiary centres across Scotland, the investigators will introduce the~     pathway as part of a stepped wedge cluster randomized controlled trial. Sequential hypothesis~     testing will evaluate the efficacy and safety of the pathway. The primary efficacy end-point~     will be length of stay from time of presentation until final hospital discharge and the~     primary safety end-point will be survival free from type 1 or 4b myocardial infarction or~     cardiac death from discharge to 30 days. The study population will consist of those patients~     with cardiac troponin concentrations within the normal reference range (<99th centile) at~     presentation.~   "
42907|NCT03005145|"~     The World Health Organization, U.S. Centers for Disease Control and Prevention, Association~     of Medical Microbiology and Infectious Diseases (AMMI) Canada, and Health Canada have all~     declared antimicrobial resistance a global threat to health, based on rapidly increasing~     resistance rates and declining new drug development. Up to 30-50% of antibiotic use is~     inappropriate, and excessive durations of treatment are the greatest contributor to~     inappropriate use. Shorter duration treatment (≤7 days) has been shown in meta-analyses to be~     as effective as longer antibiotic treatment for a range of mild to moderate infections. A~     landmark trial in critically ill patients with ventilator-associated pneumonia showed that~     mortality and relapse rates were non-inferior in patients who received 8 vs 15 days of~     treatment. Similar randomized trial evidence is lacking for the treatment of patients with~     bloodstream infection, which affects 15% of critically ill patients, and an estimated 50,000~     Canadians per year.~   "
42908|NCT03005132|"~     Integrative analysis of GBM~   "
42910|NCT03005106|"~     The proposed registration study is designed as a phase III open-label, controlled,~     randomized, multicenter study evaluating the efficacy and safety of StrataGraft skin tissue~     in promoting autologous skin tissue regeneration of complex skin defects due to thermal~     burns. The proposed study will include patients with 3-49% total body surface area (TBSA)~     complex skin defects due to thermal burns with intact dermal elements for which excision and~     autografting are clinically indicated. The study has been designed to focus on the evaluation~     of efficacy and safety of StrataGraft skin tissue, while also assessing the potential for~     StrataGraft skin tissue to promote healing of complex skin defects due to thermal burns as an~     alternative to donor site harvesting and autografting. Targeted enrollment for this study is~     up to 70 subjects with complex skin defects caused by thermal burns that containing intact~     dermal elements and for which surgical excision and autografts are clinically indicated.~   "
42911|NCT03005093|"~     The purpose of this study is to test the reliability and validity of the Turkish~     Feeding/Swallowing Impact Survey among caregivers of pediatric patients with swallowing~     disorders.~   "
42912|NCT03005080|"~     This study will use a 22 gene pharmacogenomics panel on 30 children with persistent~     Gastroesophageal Reflux Disease (GERD) who have not responded to therapy.~   "
42913|NCT03005067|"~     This study will be conducted in adult participants with symptoms of common cold assessing if~     1146A nasal spray reduces the severity of symptoms of the common cold compared to placebo.~     The study will also evaluate the safety of 1146A compared to placebo.~   "
42914|NCT03005054|"~     The proposed study is designed as a phase II open-label, controlled, randomized, multicenter,~     dose-escalation study of the safety, tolerability, and efficacy of a single or multiple~     applications of StrataGraft skin tissue as an alternative to autografting in promoting the~     healing of excised full-thickness complex skin defects resulting from acute traumatic skin~     loss. The proposed study population will include patients with up to 49% Total Body Surface~     Area (TBSA) complex skin defects including a full-thickness component. The study has been~     designed to focus on the evaluation of safety and tolerability of prolonged exposure to~     increasing amounts of a single or multiple applications of StrataGraft skin tissue, while~     also assessing the potential for StrataGraft tissue to promote healing of the full-thickness~     component of these complex skin defects as an alternative to donor site harvesting and~     autografting. Targeted enrollment for this study is up to 20 subjects with complex skin~     defects due to acute traumatic skin loss which require surgical excision and autografting.~     Subjects will be sequentially enrolled in two cohorts of increasing treatment area receiving~     StrataGraft skin tissue.~   "
42915|NCT03005041|"~     The purpose of this study is to investigate the consumer perception of an experimental~     mouthwash formulation in population with dry mouth~   "
42916|NCT03005028|"~     In the present study we aim at validating the computation of FFRangio values from the~     angiogram by comparing them to measured wire-based FFR values, in a larger scale and in a~     completely blinded manner. Investigation of a wide range of users in various conditions may~     strengthen the reliability of the FFRAngio measurements.~   "
42917|NCT03005015|"~     The primary objective of this multicenter, randomized phase II trial is to assess the~     efficacy, as measured by progression-free survival (PFS), of lenvatinib compared to~     doxorubicin in advanced or recurrent endometrial cancer.~      The main secondary objective is to evaluate the predictive value of Ang-2 on lenvatinib~     activity and establishing a cutoff value as potential selection criteria for phase III.~      Other secondary objectives are to assess the tolerability and safety of lenvatinib in this~     setting and overall survival, response and disease control.~   "
42918|NCT03005002|"~     This pilot clinical trial studies the side effects and how well durvalumab and tremelimumab~     work in treating patients with microsatellite stable colorectal cancer that has spread to the~     liver. Monoclonal antibodies, such as durvalumab and tremelimumab, may interfere with the~     ability of tumor cells to grow and spread.~   "
42919|NCT03004989|"~     To explore the experiences of individuals with musculoskeletal disorders (MSDs) who have~     participated in return-to-work group programmes (RTW-GPs) and see how the programmes could~     strengthen their work ability.~   "
42920|NCT03004976|"~     The primary objective of this study is to determine the efficacy of a single intravenous~     infusion of unrelated donor umbilical cord blood (UCB) for improving functional outcomes in~     patients with ischemic stroke. Eligible subjects will receive an intravenous infusion of UCB~     or placebo 3-10 days following stroke. Subjects will not receive immunosuppressive or~     myeloablative medications prior to the infusion. Subjects will be followed for one year post~     infusion for safety and efficacy. Assessments will examine safety and tolerability of the~     infusion, change in neurological symptoms, change in quality of life, and emotional and~     cognitive status. Assessments will occur at 24 hours post infusion, and at 30, 90, 180 and~     365 days post infusion.~   "
42921|NCT03004963|"~     Peritoneal dialysis (PD) is one of established treatments in the end stage renal disease~     patients. Volume overload is a predictor of mortality in PD patients. In this Randomized~     controlled trial, the investigators use the Body Composition Monitor (BCM), a multifrequency~     bioimpedance device, to measure the level of overhydration in PD patients and explore its~     value in fluid management in peritoneal dialysis patients as well as their prognosis.~   "
42922|NCT03004950|"~     This study is an observational non-interventional study which will examine a) the accuracy of~     biomarkers in predicting renal and cardiovascular outcomes after contrast-induced acute~     kidney injury.~      This study will obtain de-identified human plasma & urine samples and corresponding~     de-identified research study data on subjects who are enrolled into the Prevention of Serious~     Adverse Events Following Angiography (PRESERVE) study and Biomarker Collection and Analysis~     in the PRESERVE Trial (VA CSP #578). Biomarker analyses will be performed on the~     de-identified samples and merged with de-identified research study data.~   "
42932|NCT03004820|"~     This is a single-arm, open-labeled and phase II futility study. Application of Remote~     ischemic conditioning (RIC) as an adjunctive therapy to medication were involved in the~     study. The study is to test whether RIC is effective in preventing ischemic evens after a~     minor ischemic stroke/transient ischemic attack within 3 months and to explore the safety and~     compliance of chronic RIC. Medication strategy is based on physician's best judgement.~   "
42923|NCT03004937|"~     Busy Primary Care providers (PCPs) have complex practices with many competing demands, making~     it difficult to improve their HL identification rates. Little research has been conducted to~     identify effective approaches to address the poor PCP knowledge and provide tools for them to~     better identify/refer patients with HL for appropriate intervention. Current data suggests~     there is a critical need to redesign how PCPs deliver hearing health care (HHC) by developing~     focused educational programs and simple clinical management tools to help them integrate HHC~     into their practices. To address this need, this study will educate providers on hearing loss~     (HL) screening/treatment as well as create a Best Practice Alert (BPA), or clinical prompt,~     that is configured for maximal effectiveness in reminding PCPs to ask their patients if they~     think they have a HL. This combination of education for providers and clinical reminder could~     help increase HL screening rates but how much is not clear. This 5 year R21/R33 study funded~     by National Institute of Deafness and Communicative Disorders seeks to provide detailed~     understanding of both how educating providers on HL and the use of an effective BPA affects~     HL screening rates and identification for people with mild to moderate hearing loss.~   "
42924|NCT03004924|"~     The purpose of this study is to determine if an investigational treatment is effective~     compared with placebo and PVP-Iodine in the treatment of adults and children with bacterial~     conjunctivitis.~   "
42925|NCT03004911|"~     The purpose of this study is to test the efficacy of a mobile application named ProFibro to~     promote self-care, and improve symptoms and health-related quality of life in Brazilian~     patients with fibromyalgia.~   "
42926|NCT03004898|"~     CKD is a global endemic disease with increased comorbidities and mortality. The prevalence~     and the incidence of the end-stage renal disease (ESRD) are extremely high in Taiwan. The~     prevalence of CKD remains high; however, the awareness remains low. Screening of unique risk~     factor and early diagnosis of CKD can improve outcome. Furthermore, data of renal education~     deep into the community remains limited. The aims of this study are:~        1. Explore risk factors associated with CKD in the community~        2. Establish multidisciplinary care model in the community~        3. Investigate mechanistic mediators for CKD and multidisciplinary education approached in~          behavioral , physiological, immune and metabolomics aspects~        4. Provide bio-specimen repository for future study~   "
42927|NCT03004885|"~     Acute Respiratory Distress Syndrome (ARDS) still remains associated with a mortality rate of~     30 - 45 % despite improvement in mechanical ventilation. Driving pressure, defined as the~     difference between the end-inspiratory and the end-expiratory airway pressure, appears as an~     important factor contributing to mortality in patients with the ARDS. In patients already~     receiving a conventional tidal volume of 6 ml/kg predicted body weight (PBW), a driving~     pressure ≥ 14 cmH2O increases the risk of death in the hospital. One mean to lower the~     driving pressure is to decrease the tidal volume such that from 6 to 4 ml/kg predicted body~     weight. However, this strategy promotes hypercarbia by reducing the alveolar ventilation,~     providing the respiratory rate is constant. In this setting, implementing an extracorporeal~     CO2 removal (ECCO2R) therapy may offset the associated hypercarbia. The investigators have~     previously demonstrated that combining a membrane oxygenator within an hemofiltration circuit~     provides efficacious low flow ECCO2R on a renal replacement therapy monitor. In this study,~     we thought to investigate the efficacy of the PrismaLung stand-alone therapy. Using a~     PrismaFlex monitor and a HP-X circuit, a neonatal membrane oxygenator (PrismaLung) is used to~     provide decarboxylation without renal replacement therapy. The study will consist in three~     periods:~        -  The first period will address the efficacy of the PrismaLung device at tidal volume of 6~          and 4 ml/kg PBW using an off-on-off design.~        -  The second part of the study will investigate the effect of varying the sweep gas flow~          and the mixture of the sweep gas on the CO2 removal rate (random order).~        -  The third part will compare three ventilatory strategies applied in a cross-over design~          :~             1. Minimal distension: Tidal volume 4 ml/kg PBW and positive end-expiratory pressure~               (PEEP) based on the ARDSNet PEEP/FiO2 table (ARMA).~             2. Maximal recruitment: 4 ml/kg PBW and PEEP adjusted to maintain a plateau pressure~               between 23 - 25 cmH2O.~             3. Standard: Tidal volume 6 ml/kg and PEEP based on the ARDSNet PEEP/FiO2 table~               (ARMA).~      Each strategies will be apply in a random order for a duration of 22 hours. Pulmonary~     inflammatory and fibrosis pathway will be assess before and after each period using~     bronchoalveolar lavage (BAL) samples. Systemic inflammatory cytokines will also be~     investigate. Main measurements will include respiratory mechanics, transpulmonary pressure,~     work of breathing, end-expiratory lung volume and tidal ventilation using electrical~     impedance tomography.~   "
42928|NCT03004872|"~     The purpose of this study is to evaluate potential risk factors for developing postpartum~     depression or posttraumatic stress disorder during the first year postpartum in patients who~     have no preexisting history of PTSD or PPD.~   "
42929|NCT03004859|"~     Atrial fibrillation (AF) is the most common arrhythmia in Germany and is associated with an~     increased risk of thromboembolic stroke. The risk to suffer from AF increases with age. Early~     detection of AF and anticoagulation seem the most effective way of preventing ischaemic~     stroke in patients at risk. The guidelines of the European Society of Cardiology recommend~     opportunistic screening for AF by pulse check at each general practitioner visit for all~     patients aged 65 years or older.~      The objective of this study was to test whether an opportunistic AF screening with a~     hand-held diagnostic tool in a German pharmacy setting is useful in detecting unknown AF~     among people in the age of 65 and older. Besides a pulse palpation with a hand-held ECG-stick~     the screening in the pharmacies also includes a questionnaire related to demographics and~     medical history of the subject as well as several questions concerning the stroke risk~     stratification (CHA₂DS₂-VASc). Every subject with a positive test result (indication on AF)~     is insistently asked to make an appointment with his or her general practitioner. The subject~     receives an information letter for his or her general practitioner that adverts to the~     positive screening result and the necessity of further diagnostic Investigation.~      In order to assess the incidence of unknown AF as well as accomplish the secondary objectives~     of this study, two follow-ups by means of telephone interviews are performed. First, all~     subjects with a positive test result are called 8 weeks after the screening in the pharmacies~     was conducted. The subject is asked several questions concerning personal data/demographics,~     the stroke risk (CHA₂DS₂-VASc), the medical history regarding to dyspnea and stroke, the~     bleeding risk (HAS-Bled), the medication, the device, diagnostic, the therapy, the~     Intervention and the mace. 12 months after the screening in the pharmacies was performed, all~     participating subjects were called. The list of questions is similar to the one that is used~     during the first telephone interviews after eight weeks.~   "
42930|NCT03004846|"~     GSK2981278 is an inverse agonist of retinoic acid receptor-related orphan receptor (ROR)~     gamma. The aim of this study is to evaluate the safety, tolerability, clinical effect, and~     systemic exposure potential of topically applied GSK2981278 ointment in subjects with plaque~     psoriasis by treating all plaques on the body for 8 weeks. This single-center study will be~     conducted in two parts. Part A will be an open-label, single arm study and part B will be a~     double-blind, randomized, 2-arm, parallel-group, vehicle-controlled study. In Part A, 8 adult~     subjects and in Part B, 18 adult subjects with chronic stable plaque psoriasis will be~     enrolled. Total duration of study will be approximately 14 weeks. The results of this study~     will provide preliminary information about safety and efficacy of the drug and will help in~     providing the guidance for further development strategy.~   "
42931|NCT03004833|"~     The aim of the trial is to improve first-line treatment for early unfavorable cHL by~     introduction of the anti-PD-1 antibody Nivolumab with a truncated standard chemotherapy~     (AVD).~      The primary objective is to show efficacy of the two experimental treatment strategies.~     Secondary objectives are to further evaluate efficacy, show safety and feasibility and~     perform correlative studies.~   "
42968|NCT03004352|"~     The aim of the study is to determine if increased retrograde shear would further deteriorate~     the already impaired vascular function in severe COPD patients.~   "
42933|NCT03004807|"~     Older adults are susceptible to vitamin and mineral deficiencies for a variety of reasons and~     have an increased demand for many of these micronutrients. Multivitamin/multimineral~     supplement offer a simple way for adults to improve nutrient intake, but their ability to~     measurably affect micronutrient status in older adults has never been explored. This study~     intends to recruit healthy, non-smoking men aged 70 years or older. After meeting entry~     criteria, subjects will be required to restrict the use of supplements and/or fortified~     foods. A month after these restrictions have begun, subjects will come to the clinical~     research center to take cognitive tests, undergo activity monitoring, provide blood samples~     for nutrition testing, and take food frequency questionnaires. Subjects will then be~     randomized into one of two groups - one consuming a multivitamin/multimineral supplement~     (Centrum Silver Mens Formula); another consuming an inert placebo tablet. Subjects will~     consume 1 tablet each day for sixteen weeks. After this period, subjects will return to the~     clinical research center and repeat cognitive tests, activity monitor, blood sampling, and~     food frequency questionnaires. These data will be assessed to determine if multivitamin~     consumption results in changes in various nutrients versus taking a placebo (primary~     outcomes), and may results in changes lipid and lipoprotein profiles, metabolic health,~     inflammation, blood pressure or cognitive function (secondary outcomes). The investigators~     expect that results of this study will add to the gneeral understanding if~     multivitamin/multimineral formulas can improve nutrition status of older adults, and~     therefore have the capacity of altering markers of health.~   "
42934|NCT03004794|"~     Initial recruitment: 1717, 136 (7.92%) were excluded due to missing data that could not be~     obtained. The diagnosis of multiple sclerosis (MS) was revised according to the 2010 revision~     of the McDonald criteria.~      Patients analyses: 1581 Every patient was registered by his/her 14-digit unique identity~     numbers, (which is mandatory in Egypt since 1999) to make sure that every registered patient~     in different centers were counted only once.~   "
42935|NCT03004781|"~     This research compared the efficacy of two parenting interventions that vary according to the~     number and the nature of variables in reducing preschoolers' externalizing behavior (EB). The~     goal was to identify which parenting intervention format (one-variable versus two-variable)~     caused higher behavioral adjustment in children.~   "
42936|NCT03004768|"~     An oral dose in healthy subjects to obtain information about the absorption, metabolism, and~     excretion (AME) of BMS-986165~   "
42937|NCT03004755|"~     Historically, cancer research has been limited by sample acquisition in late stage disease,~     often restricted to single sites of disease with limited parallel clinical data collection in~     terms of prior therapy exposure. The PEACE study is intended to facilitate tissue donation~     from multiple tumour sites in the post-mortem setting and enable future research using~     samples collected at post-mortem within different disciplines related to cancer research.~   "
42938|NCT03004742|"~     This study will measure the effect of ingesting a flavonoid-rich supplement on various~     biomarkers in overweight/obese women during a 12-week period. The flavonoid-rich supplement~     contains a mixture of flavonoids including quercetin, catechins from green tea extract, and~     anthocyanins from bilberry extract, and other food components that facilitate flavonoid~     bioactivity including fish oil, caffeine, and vitamin C.~   "
42939|NCT03004729|"~     The Cow's Milk-related Symptom Score (CoMiSS) tool has been developed to define a score to~     recognize cow's milk related symptoms in infants and young children.~      Many infants and toddlers with symptoms that can be related to intake of cow's milk and cow's~     milk protein allergy (CMPA) are often not diagnosed due to the lack of specific markers.~      The goal of this trial is to validate the CoMiSS tool in infants suspected of CMPA and~     investigate if the CoMiSS tool could be an alternative to the open challenge test needed to~     confirm the diagnosis of Cow Milk Protein Allergy.~   "
42940|NCT03004716|"~     The purpose of this study is to assess the feasibility and the reliability of a~     telemonitoring system during pulmonary rehabilitation in patients with chronicle obstructive~     pulmonary disease.~      The feasibility is assessed using the patient's satisfaction and it ease of use.~      The reliability of the remote telemonitoring system is assessed comparing the local data~     (extracted from the monitoring device itself) and the data transmitted through the~     telemonitoring platform.~   "
42941|NCT03004703|"~     The main goal of this study is to evaluate the ability of a single administration of~     tocilizumab to reduce myocardial damage in patients presenting with an acute ST-segment~     elevation myocardial infarction (STEMI). Secondary objectives are to assess the impact of~     treatment on: (i) final infarct size, (ii) left ventricular size and function, (iii)~     inflammation, (iv) extracellular matrix remodeling, (v) lipid parameters, (vi) platelet~     activation and additional pro- and anti-thrombotic parameters, and (vii) study drug safety~     and tolerability.~   "
42942|NCT03004690|"~     Pandemics and re-emerging diseases put pressure on the health care system to prepare for~     patient care and sample logistics requiring enhanced personnel protective equipment (PPE) for~     health care workers. We generated quantifiable data on ergonomics of PPE applicable in a~     health care setting by defining error rates and physically limiting factors due to~     PPE-induced restrictions. Nineteen study volunteers tested randomly allocated head- or full~     body-ventilated PPE suits equipped with powered-air-purifying-respirators and performed four~     different tests (two laboratory tutorials, a timed test of selective attention and a test~     investigating reaction time, mobility, speed and physical exercise) during 6 working hours at~     22°C on one day and 4 working hours at 28°C on another day. Error rates and physical~     parameters (fluid loss, body temperature, heart rate) were determined and ergonomic-related~     parameters were assessed hourly using questionnaires. Depending on the PPE system the most~     restrictive factors were: reduced dexterity due to multiple glove layers, impaired visibility~     by flexible face shields and back pain related to the respirator of the fully ventilated~     suit. Heat stress and liquid loss were perceived as restrictive at a working temperature of~     28°C but not 22°C.~   "
42943|NCT03004677|"~     This study evaluates the effect of a late intervention of continuous skin-to-skin contact~     (SSC) in the neonatal intensive care unit (NICU). Half of the participants will receive the~     intervention and the other half will receive standard care.~   "
42969|NCT03004339|"~     Evaluation of safety, pharmacokinetics, and anti-psoriatic efficacy to assess SOR007 Ointment~     in topical formulations~   "
42970|NCT03004326|"~     Multi-center observational study to evaluate the histopathology and transcriptome of~     cutaneous lesions in patients with several different types of vasculitis.~   "
42944|NCT03004664|"~     BACKGROUND AND SIGNIFICANCE:~      Diabetes is a national health problem, yet Latinos from low-income households are at greater~     risk. Although guidelines recommend that patients learn self-management strategies, many~     people are not able to do so effectively and cannot control their diabetes. Studies show that~     culturally competent self-management programming can help, but patients in preliminary~     research indicated that not all programs sufficiently respect patients' cultural values or~     account for their socio-economic limitations.~      STUDY AIMS:~      This project will compare two models for culturally competent diabetes self-management~     programming. The hypothesis is that the program model that best considers patient culture and~     accommodates patient socio-economic circumstances will have the best outcomes.~      COMPARATORS:~      2 diabetes self-management program models used by many Latino patients from low-income~     households in Albuquerque, New Mexico~        1. The Diabetes Self-Management Support Empowerment Model~        2. The Chronic Care Model~      STUDY POPULATION:~      Patients will be 240 individuals who consider themselves to be Latino and who are from~     low-income households. In addition, 240 patients will identify a corresponding social support~     to participate with them. Outcomes will be measured based on the 240 patient participants.~     Social support data will be measured as a covariate to understand patient outcomes.~      PRIMARY OUTCOME:~      Improved capacity for diabetes self-management measured as diabetes knowledge and patient~     activation or the ability to put that knowledge into action.~      SECONDARY OUTCOME:~      Successful diabetes self-management measured through reduced A1c, BMI and depression. Patient~     stress levels will also be measured using testing of hair samples to identify levels of~     cortisol as a biological marker for chronic stress.~      METHODS:~      Statistical calculations will be conducted to make sure that the things being compared are~     differences in program design and not differences in individual patient characteristics. This~     study will compare whether the programs improve diabetes health knowledge, ability to act,~     and A1c, BMI, depression and stress control, and determine which program is the best.~   "
42945|NCT03004651|"~     Comparison of the level of agreement between Power Doppler ultrasound measured number of~     synovitis (≥ grade 1 on a semi-quantitative scale) and clinically defined number of swollen~     joints in obese (i.e. BMI>30) versus normally weighted RA patients.~   "
42946|NCT03004638|"~     To evaluate the safety pharmacokinetics, and pharmacodynamics of repeat weekly dosing of~     MEDI6012 in subjects with stable atherosclerosis.~   "
42947|NCT03004625|"~     A single-arm, multi-center study of HCV-1b patients without baseline non-structure protein~     (NS5A) resistance-associated variants. Daclatasvir (60mg/day) and asunaprevir (100 mg twice~     daily) plus weight-based ribavirin (1000-1200 mg/d) for 12 weeks will be prescribed.~   "
42948|NCT03004612|"~     Type 2 diabetes is a worldwide epidemic disease, and preventive strategies are needed to face~     this health problem. The goal of this clinical trial is to evaluate the effect of linagliptin~     + metformin vs metformin alone on physiopathological parameters, such as glucose metabolism,~     insulin resistance, insulin secretion and pancreatic beta cell function in patients with~     impaired fasting glucose plus impaired glucose tolerance, during 12 months.~   "
42949|NCT03004599|"~     Safety and Efficacy of SYM-SV/DS-002 in Patients with Severe Aortic Stenosis~   "
42950|NCT03004586|"~     The goal of this clinical research study is to compare the effectiveness of a smaller,~     25-gauge needle when used in an endobronchial ultrasound-guided transbronchial needle~     aspiration (EBUS-TBNA) instead of a standard 22-gauge needle.~      The safety of the needles will also be studied.~   "
42951|NCT03004573|"~     Parkinson's disease (PD) is usually responsible of cognitive and behavioral non-motor signs~     with a major impact on the quality of life. Social cognition is a complex system relying on~     emotion recognition (neurons mirror system, NMS), the theory of mind (with its two parts:~     emotional and cognitive), but also on the social and cultural environment and the personal~     history. The first step in this model is represented by the NMS, which seems to be altered in~     PD patients for both positive and negative emotions as shown in our preliminary study. The~     investigator purpose is to investigate the role of the treatment (levodopa and deep brain~     stimulation) on the functioning of the NMS.~   "
42952|NCT03004560|"~     The purpose of this study is to examine the psychological and psychosocial impact of surgical~     scars after minimally invasive surgery (MIS). 100 adult patients who are about to undergo~     bariatric procedures through the Duke Metabolic & Weight Loss Surgery program will be~     enrolled in this study. 50 patients will be randomly assigned to standard laparoscopic~     surgery and 50 will be assigned to the percutaneous group. All patients will complete~     pre-operative psychometric testing to establish a baseline body-image score as well as a~     patient's initial subjective perceptions around surgery and surgical scars. Follow-up visits~     will be done at standard of care timepoints - 3 weeks, 3 and 6 months, and 1 year after~     surgery. Subjects will complete the same psychometric measures to identify differences in~     psychological and psychosocial responses to standard laparoscopic and percutaneous scars.~     Patients will also complete a measure on scar satisfaction. The investigators hope to~     identify any differences between standard laparoscopic versus percutaneous approaches.~   "
42953|NCT03004547|"~     Sodium (Na+) hemostasis is abnormal in CKD patients, and this element can be deposited in the~     skin, muscle and skeleton - to cope with long term sodium loading. It is known that sodium~     stored in this non-osmotically active way, is profoundly inflammatory. Furthermore,~     inflammation has been associated with a number of uremic symptoms. The investigators will use~     novel Na+ MRI imaging to examine the Na+ deposition in skin, muscle and skeleton of three~     groups of patients: 1) chronic 3-times-a-week in-center hemodialysis patients, 2) peritoneal~     dialysis patients, and 3) patients with CKD stage 4-5; and compare these results to age and~     sex matched healthy controls. Additionally, they will investigate the association between~     sodium deposition in these tissues with uremic symptomatology and biochemical markers of~     metabolism.~   "
42954|NCT03004534|"~     The purpose of this study is to evaluate the effect of short-term treatment with ODM-201 on~     breast cancer cells (i.e., how the treatment may change the genes or proteins in breast~     cancer cells) and to evaluate its safety and the way it is tolerated by subjects.~      The intent is to study these changes in order to have a better understanding of the potential~     use of ODM-201 for women with EBC, know which patients are likely or unlikely to respond to~     this treatment, and determine how ODM-201 may be combined with other anti-cancer drugs.~   "
42955|NCT03004521|"~     LQD is a multicentre randomised clinical trial comparing the clinical and cost effectiveness~     of lithium versus quetiapine when used as add-on therapies to antidepressant medication for~     patients with treatment resistant depression. The Lithium versus Quetiapine in Depression~     (LQD) study will assess patients over 12 months to establish which (if any) treatment is more~     likely to improve TRD over a long duration of time. Professor Anthony Cleare is the Chief~     Investigator and recruitment began in November 2016.~   "
42971|NCT03004313|"~     The main purpose of this study is to integrate novel MRI techniques with positron emission~     tomography(PET) for the study of structural and molecular neuroplasticity in the brain of~     migraineurs, and its clinical association with changes in pain perception and modulation~     (e.g. allodynia). We will attempt to acquire images of the brain that may, in the future,~     assist doctors in better understanding how pain is felt and regulated in migraine sufferers.~   "
42956|NCT03004508|"~     Primary objective: The primary objective of this study is to assess the effect of Ginkgo~     biloba L. leaf extract (IDN 5933) in comparison to placebo in human subjects treated at~     therapeutic doses for 6 months on the level of DNA damage and genomic instability, measured~     with the Comet Assay and the Micronucleus assay, respectively .~      Secondary objective:~      The secondary objective of this study is to provide a preliminary assessment of the safety of~     Ginkgo biloba L. leaf extract (IDN 5933) in human subjects treated at therapeutic doses in~     term of adverse drug reaction, hepatotoxicity, genotoxicity.~   "
42957|NCT03004495|"~     To evaluate systemic pharmacokinetics of CHF6001 following concomitant administration of~     CHF6001 and CHF5259, in comparison with the single components, administered in healthy~     subjects via a multi-dose reservoir NEXThaler® DPI.~   "
42958|NCT03004482|"~     Video recording for term and preterm newborns hosted at the AUBMC Neonate ICU will be~     collected. The videos will capture movements, skin color changes, positioning, and other~     features relevant to the diagnosis in question. Recorded video images will be analysed by a~     computer software using the Eulerian Video magnification technology; then images will be~     correlated with simultaneously recorded physiological parameters (heart rate, respiratory~     rate and saturation). Images will be annotated by the clinician. Correlation between the skin~     coloration differentials and annotated physiological parameters may establish physiological~     indices. These may be used to extrapolate the existence or absence of disease states.~   "
42959|NCT03004469|"~     The purpose of this study is to confirm the clinical efficacy and the safety of P-3074 in~     patients with androgenetic alopecia.~   "
42960|NCT03004456|"~     Children with chronic diseases, particularly those who have received transplantation (e.g.~     cardiac, renal, or liver) are a population who undergo frequent painful procedures, such as~     venipuncture multiple times per week. There is currently no standard of care for pain~     reduction during venipuncture for pediatric patients having blood drawn in phlebotomy as an~     outpatient. The study aims to determine the efficacy of distraction in reducing procedural~     pain and distress associated with venipuncture in pediatric post-transplant patients.~   "
42961|NCT03004443|"~     Increased inflammation has been implicated in the pathophysiology of a number of~     neuropsychiatric illnesses including mood disorders, which affect almost 30 million adults in~     the United States alone. One mechanism by which inflammation may alter behavior is through~     increasing brain glutamate, a neurotransmitter that in excess has been implicated in neuronal~     toxicity and resistance to conventional antidepressant therapy. The goal of the proposed~     research is to test the hypothesis that inflammation alters behavior through increasing~     glutamate in specific brain regions, ultimately leading to behavioral changes.~      The proposed research is designed to determine the cause and effect relationship between~     inflammation and CNS glutamate as well as the relationship between CNS glutamate and specific~     symptoms. To accomplish these aims, investigators will administer a single infusion of either~     the tumor necrosis factor (TNF) antagonist infliximab or placebo (n=30 per group) to patients~     with high inflammation (CRP>3mg/L). A CRP>3mg/L was chosen because it is considered high~     inflammation according to guidelines by the American Heart Association. Moreover, a CRP>3mg/L~     is associated with significantly increased basal ganglia glutamate and with a clinical~     response to infliximab. Inflammatory biomarkers, basal ganglia glutamate as measured by MRS,~     and motivation and psychomotor activity will be assessed at baseline and days 1 and 3 and~     weeks 1 and 2 following infliximab or placebo administration.~   "
42962|NCT03004430|"~     To evaluate effects of mantra meditation on depressive symptoms if applied as adjunctive~     therapy to psychotherapy and/or antidepressant drugs and to explore if meditation leads to~     increased spirituality as a potential mediating factor of positive mental health.~   "
42963|NCT03004417|"~     Effect of CHF 6001 on biomarkers of inflammation in induced sputum and in blood, on pulmonary~     function and on symptoms benefits in comparison with placebo.~   "
42964|NCT03004404|"~     The primary objective of the SRD part (trial part 1) is to investigate the safety and~     tolerability of BI 730357 in healthy subjects following oral administration of single rising~     doses after fasting and/or non-fasting conditions. The secondary objective is the exploration~     of the pharmacokinetics (PK) including dose proportionality, and pharmacodynamics of BI~     730357 after single dosing.~      The objective of the Bioavailability (BA) part (trial part 2) will be to explore the relative~     bioavailability of tablet fasted versus oral solution fasted and the influence of food on the~     bioavailability of tablet fasted versus tablet fed.~   "
42965|NCT03004391|"~     In 2015 the Danish Health authorities initiated major changes in the national follow-up (FU)~     program for ovarian cancer patients. The new FU program argues that there is no effect of~     routine monitoring of tumour marker CA125. Now every patient needs to choose if they wish~     routine measurement of CA 125 to be part of the follow-up program.~      Shared Decision Making (SDM) can help health professionals develop a more individualized care~     plan in collaboration with the patient, as stated in the revised national FU program. Due to~     the complexity and challenges within ovarian cancer care, this is an evident area of focus.~      SDM is defined as an approach in which the clinician and patient go through all phases of the~     decision-making process together and share the preference for treatment and reach an~     agreement on treatment choice. Clinicians have information about disease, tests and~     treatments, whereas patients hold information about their life circumstances, goals of life,~     and preferences for healthcare. SDM thereby offers a way of individualizing recommendations,~     according to patients' special needs and preferences. SDM has potential to give the patients~     a higher quality of healthcare by putting the patient in the center of care.~      Decision aids (DA) are tools that can provide information and systematically describe the~     advantages and disadvantages of a specific intervention or monitoring, which can help~     patients become involved in decision making. Using evidence-based DA leads to improvement in~     knowledge, better understanding of screening, prevention and treatment options, and more~     accurate perception of risks for the patients.~      All participants fill in a demographic and Decisional Conflict Scale questionnaire at~     baseline. After having been presented with the decision aid and made a choice as to CA125,~     the participants will complete the CollaboRATE and Decisional Conflict Scale questionnaire~     dealing with confidence as to the choice made and the level of shared decision making~     experienced. Six months later the Decision Regret Scale questionnaire is to be completed to~     reveal any regrets in relation to the CA125 decision.~      For a preliminary investigation of the applicability of the DA, 15-20 patients not eligible~     for this study will be asked for their opinion.~   "
42966|NCT03004378|"~     This study will be the first to evaluate whether the short- and long-term use of activity~     tracking devices improve short- and long-term weight loss in adolescents. The investigators~     will be the first to establish whether weight loss translates into a change in~     obesity-related biomarkers associated with adolescent obesity. In addition, the investigators~     will be the first to report outcomes after the implementation of activity tracking devices in~     conjunction with an intense adolescent weight loss program.~   "
42967|NCT03004365|"~     The purpose of this single-blind study is to evaluate whether C16G2 Varnish administered in~     multiple doses can effectively kill the bacteria in the oral cavity that cause dental caries.~   "
42972|NCT03004300|"~     The most frequent causes of mouth breathers are the adenotonsillar hypertrophy.~     Adenotonsillectomy is the main choice for the elimination of the obstruction. However, this~     surgical treatment does not have its effect well elucidated and apnea has been cited in the~     literature as a residual outcome. Other types of supporting treatment may also been involved~     such as the use of corticosteroids, physiotherapy and orthodontic-orthopedic treatment, among~     them rapid maxillary expansion (RME).~      RME corrects the morphological constriction of the upper arch caused by buccal breathing and~     also reduce the airway resistance. Despite reports of RME influencing volume enhancement in~     pharyngeal airway, there are still few three-dimensional studies following the post-expansion~     effects. In addition, these changes are doubtful due postural changes of the tongue during~     the tomography exam. Conflicts of results are also present for changes in the nasal septum of~     children. The main alteration mentioned is the increase in the length of the lower third of~     the septum.~      The investigators propose a randomized, prospective, controlled clinical trial in patients~     with atresic maxilla with or without adenotonsillar hypertrophy. The patients will be treated~     with RME and adenotonsillectomy when the obstruction is present. The purpose of this study is~     elucidate if there is different outcomes considering the moment of RME treatment before or~     after the adenotonsillectomy.~   "
42973|NCT03004287|"~     This study will assess whether adding one of the newest multiple myeloma therapies,~     daratumumab, into the Total Therapy approach helps patients live longer with fewer side~     effects~   "
42974|NCT03004274|"~     The goal of this study is to assess whether running deep wound stiches will be superior to~     deep interrupted stiches in body contouring surgeries in massive weight loss patients. This~     is a split-wound study, thereby providing an internal control within each wound. Each side of~     the wound will be randomized to receive one of the two suturing techniques. Patients and~     raters will be blinded to the suture technique used in both wound-halfs.~   "
42975|NCT03004261|"~     Human cytomegalovirus (CMV) infection is a major cause of morbidity and mortality for~     recipients of allogeneic hematopoietic stem cell transplantation(HSCT). we propose to study~     the immunologic and virologic effects of donor derived CMV specific cytotoxic T lymphocyte~     (CMV-CTL) given to transplant recipients~      CMV antigen peptides will be used to induce the CMV antigen specific T lymphocytes derived~     from donor peripheral blood mononuclear cells for a period of 18~21 days.The patients will~     receive CMV-CTL cells when they are sero-positive for CMV-DNA 30 days after transplant. The~     CMV-DNA level will be monitored weekly after transfusion.~   "
42976|NCT03004248|"~     This is a long term safety study of DaxibotulinumtoxinA for Injection for the treatment of~     moderate to severe glabellar lines following single and repeat administration.~   "
42977|NCT03004235|"~     The purpose of this study is to collect non-invasive observational data in suspected or known~     carbon monoxide poisoning.~   "
42978|NCT03004222|"~     The purpose of this research is to determine if spraying a local anesthetic to the cecum~     after a laparoscopic appendectomy decreases the amount of narcotics (pain medicine) needed~     after surgery and reduces the time to discharge from the hospital.~   "
42979|NCT03004209|"~     This study evaluates the efficacy of erythropoietin in refractory autoimmune encephalitis.~     Ten patients will receive 100 IU/kg of erythropoietin 3 times a week for 12 weeks.~   "
42980|NCT03004196|"~     Orthodontic appliance causes increase in plaque accumulation, especially around brackets,~     wires and attachments. Advances in orthodontics in recent time have led to improved quality~     of appliance and treatment procedures ultimately resulting in improvised standard of patient~     care.~      These bacteria metabolize different kind of carbohydrates accumulated around orthodontic~     appliances and create acidic environment in the oral cavity leading to enamel~     demineralization around the brackets and white spot lesions.~      This study was carried out to evaluate and compare the efficacy of probiotic toothpaste and~     chlorhexidine mouthwash in patients undergoing orthodontic treatment with individuals who are~     not using them.~   "
42981|NCT03004183|"~     This is a Phase II trial to determine the efficacy and safety of stereotactic body radiation~     therapy (SBRT) and in situ oncolytic virus therapy used as a window of opportunity treatment~     before pembrolizumab in patients with metastatic triple negative breast cancer (TNBC) and~     metastatic non-small cell lung cancer (NSCLC). In situ oncolytic virus therapy will consist~     of adenovirus-mediated expression of herpes simplex virus thymidine kinase (ADV/HSV-tk) plus~     valacyclovir therapy.~   "
42982|NCT03004170|"~     The purpose of this study is to determine if a brief behavioral intervention delivered over~     the telephone is effective at reducing occasions of condomless sex in persons living and~     aging with HIV.~   "
42983|NCT03004157|"~     Pediatric cardiac arrest is an uncommon but critical life-threatening event requiring~     effective cardiopulmonary resuscitation (CPR). About 16,000 pediatric cardiac arrests occurs~     in the United States annually. Only 8% of the patients survive to hospital discharge and of~     these, up to two-thirds have neurological sequelae. Majority of pediatric cardiac arrest are~     below age of two and have poorer chance of survival versus older children~   "
42984|NCT03004144|"~     This study is a cross-sectional study investigating the impact of assistive forces applied by~     the body-weight support system the FLOAT on the study participants. The study is conducted~     at the University Hospital Balgrist in Zurich over a period of around 3 years. During this~     time measurements on approximately 120 able bodied subjects and 20 patients with an~     incomplete spinal cord injury will take place. The study participants are invited for a~     single visit of around 140 min duration to the University Hospital Balgrist. During this~     visit the study participants will repeatedly perform various activities of daily living (free~     walking, standing up and sitting down, stair climbing and balancing) with and without~     assistive forces from the body-weight support system. While performing the tasks, the study~     participants' motions and muscle activities will be measured to evaluate the naturalness of~     their movements. In addition, the collected data permits us to compare different movement~     patterns and make conclusions about effective and optimal movement support. Obtaining this~     knowledge will help us to shape the therapy of these activities to be tailored to the~     patients and to train these movements with the help of the FLOAT under optimal conditions.~   "
42985|NCT03004131|"~     This study is to assess the onset of action of fixed drug combination of azelastine~     hydrochloride and fluticasone propionate nasal spray (MP-AzeFlu) in treating the nasal~     symptoms of seasonal allergic rhinitis (SAR) induced by an allergen challenge in an~     Environmental Exposure Chamber (EEC).~   "
42986|NCT03004118|"~     The investigators aim to evaluate ursochol as a therapy in functional dyspepsia. The~     objectives of the study are to evaluate the effect of ursochol on duodenal permeability and~     dyspeptic symptoms and on duodenal low-grade inflammation, bile acid composition, bile acid~     receptor expression, nutrient tolerance and intragastric pressure.~      Cross-over, controlled, randomized, double blinded, placebo-controlled trial with a 4 week~     intake of ursodeoxycholic acid (ursochol) versus a 4 week intake of placebo and a 4 week~     washout period in between. Two study days are planned during week 4 and week 12. During the~     14 weeks, the patients have to fill in a diary. And for 14 weeks in total, the patients have~     to discontinue intake of proton pump inhibitors, drugs effecting gastric motility and NSAIDs~     and replace their oral anticonception with non-oral anticonception. Every two weeks of the~     study the investigator will call the participants to see how they are/if they have any~     discomforts or side effects.~   "
42987|NCT03004105|"~     The goal of this clinical research study is to learn if MEDI4736 given in combination with~     selumetinib can help to control advanced lung cancer.~      The safety of this drug combination will also be studied.~   "
42988|NCT03004092|"~     Diagnosis of invasive aspergillosis remains difficult, and is often based on a combination of~     patient characteristics, radiological and microbiological findings. To data, galactomannan~     (GM) is the only well-validated biomarker available. However, GM still has its shortcomings.~     There is therefore a need for new, complementary biomarkers. In this study, two of those~     tests, bis(methylthio)gliotoxin (bmGT) and a lateral flow device, will be validated in a~     hematological population, and compare it to GM.~   "
42989|NCT03004079|"~     The purpose of this study is to assess the relationship of blood glucose levels in persons~     with Multiple Sclerosis (MS) who have experienced a relapse and will be receiving intravenous~     steroids for the relapse, to their recovery from the relapse.~      Steroid exposure commonly leads to elevated serum blood glucose, however, standardized~     monitoring of blood glucose levels in the outpatient setting is not common. The clinical~     impact of any associated elevated blood glucose during steroid administration is unknown. We~     hypothesize that the blood glucose response to steroid treatment is clinically relevant to~     the MS-relapse recovery.~   "
42990|NCT03004066|"~     10 patients with chronic heart failure receiving daptomycin therapy after implantation of a~     left ventricular heart assist system. Measurement of daptomycin levels in drainage fluids~     (mediastinal and pleural drainage systems) and in blood samples.~   "
42991|NCT03004053|"~     The purpose of this study is to obtain images (pictures) of normal oral tissue, which occur~     inside the mouth, using a special camera. These pictures will be used in our research to~     evaluate a new technology that uses a laser and takes pictures of the microscopic structure~     of tissue. The technology is called reflectance confocal microscopy.~   "
42992|NCT03004040|"~     The investigators propose a unique methodology of studying infection and vaccination history~     and immune responses. As most studies in infection history are conducted on mice, limitations~     are inherent on their applicability to humans. A longitudinal comparison study following~     older adults (over the age of 65) hospitalized for influenza are followed through to their~     hospital discharge and vaccination in the following season. This will allow for the~     investigation of the course of infection, as well as impact on the response to vaccination.~   "
42993|NCT03004027|"~     Individuals with visible conditions often report experiencing lowered social confidence and~     encountering intrusive reactions from others, yet relatively few targeted psychosocial self~     help interventions are available.~      The investigators will conduct a randomised controlled trial to compare the efficacy of an~     adapted form of an existing self-help intervention with an enhanced version of the same~     intervention that incorporates if-then planning instructions (or 'implementation intentions')~     and a control condition that will receive support as usual. Participants who self-identify as~     having a visible condition affecting the skin or hair, or scarring to the skin that~     negatively affects their social confidence will be allocated to one of three conditions:~     augmented self-help, standard self help or control. The interventions will be delivered~     online and participants will complete psychometric outcome measures at two time points, four~     weeks apart.~      It is hypothesised that participants who receive the augmented self help intervention will~     have a statistically significant decrease in fear of negative evaluation in comparison to~     both the standard self-help and support as usual control groups.~   "
42994|NCT03004014|"~     Drug induced sleep endoscopy (DISE) has been performed worldwide since 1991 to determine the~     site and configuration of upper airway obstruction in patients with obstructive sleep apnea~     (OSA). However, there are no studies comparing DISE to sleep endoscopy during natural sleep.~     Objectives: To compare DISE to natural sleep endoscopy in OSA patients referred for surgical~     treatment.~      Methods: OSA patients referred to surgical treatment (lateral pharyngoplasty) will be~     enrolled in this study. Natural sleep endoscopy will be performed at the sleep lab during the~     night. Propofol induced sleep will be performed at the operating room before surgery. The~     VOTE (velum, oropharyngeal lateral walls, tongue base and epiglottis) classification will be~     used to compare site and configuration of collapse between studies. Peak inspiratory flow~     will also be compared between studies.~   "
42995|NCT03004001|"~     The study purpose is to determine the hypolipidemic effect of Alirocumab co-administered with~     atorvastatin on levels of triglyceride-rich lipoproteins and LDL compared to monotherapy with~     atorvastatin in patients with dyslipidemia secondary to nephrotic syndrome.~   "
42996|NCT03003988|"~     This study was designed to examine how different forms of creatine impact active males.~   "
42997|NCT03003975|"~     This is a clinical study where the investigators will assess the efficacy of a single~     cryoballoon application per vein guided by a multipolar recording catheter as compared with a~     conventional technique with 2 cryoballoon applications for pulmonary vein isolation (PVI) in~     patients with atrial fibrillation (AF).~   "
42998|NCT03003962|"~     This is a randomized, open-label, multi-center Phase III study to determine the efficacy and~     safety of durvalumab versus platinum-based SoC chemotherapy in the first-line treatment of~     advanced NSCLC in patients who are epidermal growth factor receptor (EGFR) and anaplastic~     lymphoma kinase (ALK) wild-type and with PD-L1-high expression~   "
45337|NCT02973438|"~     The purpose of this research is to examine changes in blood glucose control and metabolism in~     individuals with SCI and non injured controls at rest and during exercise after five days of~     exposure to IH. This response will be compared with breathing normal room air (a SHAM~     control).~   "
42999|NCT03003949|"~     Women in the menopause transition ('perimenopause') are exposed to extreme hormone~     variability, tend to experience a unique set of severe stressors (e.g., divorce, death of~     loved ones), and are also at substantially elevated risk to suffer from mood and anxiety~     disorders. The purpose of this research is to understand the mechanisms by which variability~     in estradiol (E2) is associated with the symptoms of anxiety and anhedonia (loss of interest~     and pleasure - a common symptom of depression). By stabilizing E2 variability with a hormonal~     manipulation, this research will determine the degree to which the E2 variability (or E2~     levels) plays a causal role in perimenopausal anxiety and anhedonia symptoms and whether it~     does so by affecting biological responses to stress.~   "
43000|NCT03003936|"~     The purpose of this investigation is to assess in a community-based cohort of late-night~     eaters the effect of coincident food intake and endogenous melatonin on glycemic control, and~     the putative interaction effect of melatonin receptor 1B (MTNR1B) genetic variation on this~     relationship. With the results from this study, the investigators expect to advance in the~     understanding of the role of endogenous melatonin on glucose metabolism in late night eaters~     and carriers of the MTNR1B risk allele, with potential implications on the guidelines to~     mitigate risk of type 2 diabetes in late night eaters and carriers of the MTNR1B risk allele.~   "
43001|NCT03003923|"~     The aim of this cluster randomised control trial is to test the efficacy of a repeated taste~     exposure intervention, a nutritional educational intervention and combination of both to~     increase intake of an unfamiliar vegetable in preschool aged children (aged 3-5 years).~   "
43002|NCT03003910|"~     This study is aimed to test the efficacy of a positive psychological intervention for~     promoting positive emotions and optimistic thinking in eating disordered patients.~     Participants are randomly assigned to receive the positive intervention or the control~     condition, which consists on thinking about daily activities.~   "
43003|NCT03003897|"~     Dietary fiber intake is protective against overweight and obesity; however, a significant~     fiber gap exists between consumption and recommended intake values. Soluble fiber~     beneficially impacts metabolism, and supplementation may be a feasible approach to improve~     body composition and glycemia in overweight and obese individuals. The investigators will~     evaluate results of randomized controlled trials (RCTs) of soluble fiber supplementation~     among overweight and obese adults for outcomes related to weight management (e.g. body mass~     index [BMI], body weight, body fat percentage, waist circumference) and glucose and insulin~     homeostasis (e.g. fasting glucose, homeostasis model assessment of insulin resistance~     [HOMA-IR], fasting insulin) through systematic review and meta-analysis.~   "
43004|NCT03003884|"~     The purpose of this study is to find out the optimal dose for Remimazolam Tosilate as a~     procedural sedative during a diagnostic upper GI endoscopy and to assess its efficacy and~     safety profile comparing to propofol.~   "
43005|NCT03003871|"~     Stroke is the second most common cause of death worldwide and is the predominant cause of~     permanent disability among older people. The mouth becomes a very unhealthy place after~     stroke, where yeasts and pathogenic bacteria multiply at an accelerated rate. Poor oral~     hygiene results in increased dental plaque, gingival bleeding, and the harbouring of oral~     opportunistic pathogens. Dental plaque acts as a reservoir of pathogenic microorganisms which~     results in additional oral health problems and also can cause life-threatening medical~     complications; most notably aspiration pneumonia and/or recurrent stroke. The first six~     months following stroke is a particular vulnerable period to survive.~      Removal of dental plaque and its associated pathogenic microorganisms is challenging in this~     compromised state of reduced manual dexterity and weak state following a stroke. Powered~     (electric) toothbrushes can be of assistance in plaque removal in frail elders. For more~     resistant oral pathogens, anti-plaque/anti-microbial mouthrinses can offer additional help in~     controlling dental plaque and thereby prevent harbouring potentially life threatening oral~     pathogens. Over the years the Faculty of Dentistry and the Stroke Rehabilitation Unit of the~     Department of Medicine in Hong Kong have been actively working together to address the~     problems of oral health associated with stroke; and specifically the challenge of~     safeguarding the life and health of stroke survivors during the vulnerable rehabilitation~     period. We are now proposing to involve stroke patients during out-patient rehabilitation in~     a randomized clinical trial to test the effectiveness of powered tooth brushing and a~     chlorhexidine anti-microbial mouthrinse in reducing dental plaque accumulation and oral~     pathogens; and how this affects their general and oral health status. We anticipate that all~     participants will benefit from the oral health promotion initiatives and that the advantages~     will be long lasting. We expect to demonstrate a 'gold standard' of oral health preventive~     care, as part of stroke rehabilitation, that can reduce (or has potential to reduce) serious~     medical complications after a stroke. If proven effective this oral health preventive care~     regime (which is relatively easy to implement and at low cost) could widely be adopted in~     stroke rehabilitation globally.~   "
43006|NCT03003858|"~     The purpose of this observational, non-controlled, single site trial with a retrospective~     design is to verify, in a large paediatric population affected by gingivitis, the~     tolerability and safety of 0.1% HA-based film-forming devices (Gengigel Prof® Fluid,~     Ricerfarma) administered three to five times a day over a 4-week period as an adjunct to~     domiciliary care and oral hygiene instructions~   "
43007|NCT03003845|"~     For each patient in the study, blood, and pain scores will be collected to look for markers~     for pain, at the start of treatment and 6 months after surgery of treatment.~   "
43008|NCT03003832|"~     The goal of this research is to investigate the impact of changing opioid analgesic~     prescribing defaults on the quantity of opioids prescribed for acute non-cancer pain in adult~     primary care and emergency department settings. We will change prescribing defaults for~     select short-acting opioid analgesics including immediate release oxycodone and hydrocodone~     as well as codeine and tramadol, including their co-formulations with acetaminophen. In a~     cluster-randomized trial of matched pairs of Montefiore Medical Center clinical sites,~     stratified by specialty and teaching status, we will evaluate the impact of this intervention~     on patient-level outcomes using 18 months of data (6 months pre-intervention and 12 months~     post-intervention).~   "
43009|NCT03003819|"~     A prospective RCT of intact extractions with delayed implant placement comparing extraction~     socket management effectiveness and office economics of two collagen matrices. Soft tissue~     wound healing will be assessed out to 4-months post-operative, when implants will be placed.~   "
43031|NCT03003520|"~     This Phase 2, two-arm, open-label study is designed to evaluate the safety, clinical~     activity, predictive biomarkers and pharmacokinetics/ pharmacodynamics of durvalumab in~     combination with R-CHOP (Arm A) or R2-CHOP (Arm B), followed by durvalumab consolidation~     therapy in previously untreated subjects with high-risk DLBCL.~      Patients with non-ABC subtype (determined by gene expression profiling) will be allocated to~     Arm A while patients with ABC (activated B-cell type) subtype will be allocated to Arm B.~     Approximately 120 patients may be enrolled and assigned into the appropriate treatment arms~     dependent upon their cell of origin status.~      Induction treatment with R-CHOP (± Lenalidomide) will last for a total of up to 6 to 8~     treatment cycles (21 days cycle), and the total time on study treatment, including durvalumab~     consolidation, will last up to 12 months.~   "
43010|NCT03003806|"~     The DreaMed Advisor Pro is a software which automatically analyses treatment information,~     learns patient's needs and accordingly suggests adjustments in insulin dosing. The DreaMed~     Advisor Pro uses information gathered from glucose monitoring (sensor readings or capillary~     blood glucose measurements), insulin dosing and meal data during daily routine home care.~     Following a 5-minute data collection and analysis, the algorithm learns and suggests~     pump-setting changes for optimization of glucose control~      The algorithm is designed as an advisory tool and has three main components:~        1. A statistical analysis of the insulin pump and sensor data: insulin delivery,~          bolus-calculator rate of use, sensor glucose variables, hypoglycemic and hyperglycemia~          patterns.~        2. Practical recommendations, alert messages based on aforementioned data~        3. Recommendation for new insulin pump settings: including basal intervals and rate,~          different carbohydrate ratio according to time of day, correction factor and insulin~          sensitivity time.~      The main goal of the DreaMed Advisor Pro is to improve diabetes management for subjects with~     Type 1 Diabetes (T1D) by using an innovative Advisor to determine insulin dosing for pump~     users.~      The main objective of the proposed study is to evaluate the safety and efficacy of using the~     DreaMed Advisor Pro algorithm versus medical guided recommendation to determine insulin~     dosing for sub-optimal controlled subjects with type 1 diabetes using pump therapy.~   "
43011|NCT03003793|"~     The incidence of atopic dermatitis and type 2 diabetes, respectively, has increased over many~     years. Novel research shows an association between the two conditions. While this~     relationship at least in theory can be explained by lifestyle factors, there is reason to~     believe that other pathophysiological mechanisms are involved. Hence, our hypothesis is that~     patients with atopic dermatitis are insulin resistant due to their chronic inflammatory~     state. Insulin resistance might play an unknown part in the increased frequency of type 2~     diabetes among patients with atopic dermatitis. In the present project, the investigators aim~     to measure insulin sensitivity by means of the 'golden standard' hyperinsulinaemic~     euglycaemic clamp in patients suffering from atopic dermatitis compared to a healthy control~     group (matched case-control study). The project is a close collaboration between The~     Department of Dermatology and Allergy and Center for Diabetes Research at Gentofte Hospital.~   "
43012|NCT03003780|"~     This is a developmental project with two phases. The first phase will adapt an existing~     web-based intervention to incorporate mind-body exercises to develop a multi-modal~     intervention to promote physical activity in patients with COPD and HF. The second phase will~     pilot test this new intervention in a longitudinal study (subjects randomized to intervention~     or usual care).~   "
43013|NCT03003754|"~     Despite exercise training decrease blood fasting glycemia in 'average' terms, there is a wide~     interindividual variability after exercise training explored mainly in adults but not in~     children. Thus, is yet unknown what baseline health status as well as the influence of what~     health variable may produce more/less non-responder (NR) prevalence (i.e., percentage of~     subjects who experienced a non-change/worsened response after training in some metabolic~     outcomes) after exercise training in school children.~   "
43014|NCT03003741|"~     There is a new form of bupivacaine, called Exparel, which can be injected into the eye socket~     during surgery and may provide pain relief for up to 72 hours. The purpose of the study is to~     compare the plain bupivacaine injection to Exparel, to see if one medication works better~     than the other.~   "
43015|NCT03003728|"~     This study will evaluate the ability of Expanded Natural Killer (ENK) cells to treat multiple~     myeloma when administered as part of a regimen consisting of Elotuzumab and a stem cell~     transplant. Natural killer cells are a special type of white blood cells that are already~     present in the body which have the ability to kill myeloma cells. In this study, natural~     killer cells will be collected and then treated in a laboratory to activate and 'expand' the~     number of cells to increase the dose and the anti-myeloma activity of the cells before they~     are transfused back into the subject. Elotuzumab is a protein drug approved by the United~     States Food and Drug Administration (FDA) for patients with previously treated multiple~     myeloma and works by activating natural killer cells already present in the body and~     targeting a protein called SLAMF7 which is present on both natural killer cells and myeloma~     cells. The investigators hope that administering Elotuzumab in combination with ENK cells~     will enhance the anti-myeloma activity of the ENK cells.~   "
43016|NCT03003715|"~     The main goal of this study to integrate techniques producing images of the brain (also~     called neuroimaging techniques) with non-invasive brain stimulation to investigate factors~     that may be associated with chronic pain in patients with Trigeminal Neuropathic Pain (TNP).~   "
43017|NCT03003702|"~     Chronic Obstructive Pulmonary Disease (COPD) is a common, long term condition of the lungs~     that is usually caused by cigarette smoking. In addition to daily symptoms and limitation in~     activities, patients are prone to developing chest infections called 'exacerbations'.~     Exacerbations are a big problem: unpleasant for patients, and sometimes severe enough to~     cause hospital admission (and therefore health facilities pressures) and death. Reducing the~     impact of exacerbations is very important. We have previously shown that earlier treatment of~     COPD exacerbations results in faster recovery, and reduced chance of hospital admission.~     Helping patients to detect exacerbations early is therefore important. We have also recently~     shown that monitoring heart rate and oxygen saturation via a finger probe may assist in this.~     However, measuring these variables when the patient is awake means they can be affected by~     other things, such as exercise and anxiety. Our new idea is that measuring heart rate and~     oxygen level overnight, when a patient is asleep, will give the best chance of detecting COPD~     exacerbations early and our study will test that. We will randomly allocate 64 patients with~     COPD recruited from our service in London to standard monitoring, or overnight monitoring,~     for up to six months or the first exacerbation, whichever is sooner. We will then analyse~     whether overnight monitoring was able to detect exacerbations earlier, and therefore could be~     used to help patients get treatment earlier. A subset of participants will also wear an~     activity monitor overnight for the first two weeks, so that we can assess the effect (if any)~     of overnight awake periods (such as trips to the bathroom) on the heart rate and saturation~     recording.~   "
43032|NCT03003507|"~     Hyperglycemia is a known risk factor for mortality in critically ill patients. Most of these~     patients receive enteral feeding. There is controversy about ideal carbohydrate composition~     of these diets. The aim of this study was to compare an enteral formula with the same~     proportion of carbohydrates with and without fructose on blood glucose levels.~   "
43018|NCT03003689|"~     Dental bacterial plaque is the most frequent modifiable finding in patients with periodontal~     (gum) diseases. Many studies have provided evidence that mechanical removal of dental plaque~     is critical for improving the periodontal health. The standard initial treatment of~     periodontitis (gum disease) is to remove plaque and calculus form the teeth and root~     structures using sclaing and root planing (SRP). Typically hand instruments and an ultrasonic~     scaler are used for SRP~      While this method removes some of the bacteria that leads to periodontitis, microorganisms~     are not completely eliminated through SRP. Studies have shown that after 3 months, the~     bacteria initially present prior to scaling and root planing had recolonized. In order to~     prevent recurrence of periodontitis, it is recommended that oral bacteria be kept at low~     levels.~      When used at the proper wave length, dental lasers have been shown to effectively removes~     calculus, without damaging surrounding tissue. The Er:YAG laser has been FDA-approved for the~     use of scaling and root planing in Dentistry. While studies on the Er:YAG laser have shown~     that it is effective in removing calculus and preserving the tooth root structure, there is~     no consensus of the level of calculus removal. The Er:YAG laser may also be more effective in~     removing microbial bacteria than SRP with hand instruments and ultrasonic scaler.~      The purpose of this study is to evaluate the effectiveness of the Er:YAG laser, as an adjunct~     to scaling and root planing, in removing microbial bacteria. Participants with chronic~     periodontitis will be randomized to have one quadrant undergo scaling and root planing using~     hand instruments and ultrasonic scaler alone, while a second quadrant will receive the same~     treatment, with the addition of the Er:YAG laser. Outcomes studies will be traditional~     periodontal clinical parameters at 6 weeks and 3 months after treatment. Microbial cultures~     will be performed at baseline and 3 months to compare survival and re-population by~     periodontal microorganisms.~   "
43019|NCT03003676|"~     This is a multi center, phase I pilot study of sequential ONCOS-102 and pembrolizumab in~     patients with advanced or unresectable melanoma progressing after PD1 blockade. The primary~     objective of the study is to determine the safety of sequential treatment with ONCOS-102~     followed by pembrolizumab. The protocol aims to enroll patients into two cohorts: prior PD1~     monotherapy or prior PD1 plus ipilimumab given sequentially or concomitantly.~   "
43020|NCT03003663|"~     The purpose of this study is to determine the effect of an Internet-of-Things bed fall~     solution when used in a hospital setting.~   "
43021|NCT03003650|"~     First-In-Man Study on the ACURATE TF™ Transfemoral Aortic Bioprosthesis Implantation in~     Patients with Severe Aortic Stenosis to collect human feasibility data pertaining to the~     safety and performance of the device.~   "
43022|NCT03003637|"~     This is a phase IB/II trial to examine feasibility and safety of checkpoint blockade (aPD1~     with or without aCTLA4) neoadjuvant to standard of care (SOC) in advanced stage head and neck~     squamous cell carcinoma (HNSCC), a patient population in need for improved clinical outcome~     and in tumors likely to respond to neoadjuvant aPD1 and aCTLA4. In addition, with this~     research protocol the potential impact of intratumoral hypoxia on tumor infiltrating~     lymphocyte (TIL) abundance, differentiation and effector function will be assessed, and the~     potentially divergent effects of T cell checkpoint blockade in areas of hypoxia and normoxia.~   "
43023|NCT03003624|"~     The aim of the present study was to compare the outcomes of incisions made by Colorado®~     microdissection needle, electrosurgery tip and surgical blade during periodontal surgery.~   "
43024|NCT03003611|"~     The investigators will compare the operated patients for a beginning breast cancer in the~     Hypnose arm and the patient in the classical general anesthesia arm. It is a Observational~     study as we cannot randomized patient, (they need to be compliant with Hypnose).~      Patient will be informed that some parameters, about his recovery, will be collected from~     their medical file. They will not have another particular treatment because they are in the~     study. It is just a prospective data collection.~      The patient will be compared on several items after the surgery ( as pain and pain killer~     intake, the heal process of the scar, etc...) Also the investigators will compare the impact~     of hypnose on the other treatments the patient received.~      The investigators need approximately 150 patients (Half in each arm).~   "
43025|NCT03003598|"~     In this study, the investigators aimed to compare the effects of endotracheal intubation via~     direct laryngoscope (DLS) and McGrath Videolaryngoscope (VL) on intraocular pressure.~   "
43026|NCT03003585|"~     In this study, the investigators aimed to compare the effects of direct laryngoscopic and~     fiberoptic endotracheal intubation on intraocular pressure.~   "
43027|NCT03003572|"~     Primary Sjögren's syndrome (pSS) can affect various organs, sometimes leads to~     life-threatening conditions and is always responsible for a decreased quality of life. Its~     evolution is chronic, with flares and relapses, and the need for reliable biomarkers to be~     carried out routinely is major in patients' follow-up. Because of the existence of~     autoreactive immunoglobulins E (IgE) in autoimmune diseases, the recently described role for~     anti-Ro/SSA antibodies in inducing interferon alpha (IFNα) signaling and the specific~     pharmacologic properties of IgE, anti-Ro/SSA IgE should be an interesting biomarker to~     determine pSS's activity. The aim of the study is to evaluate whether the proportion of~     anti-Ro/SSA IgE positive patients is higher in patients with active disease (i.e. Eular~     Sjögren Syndrome Disease Activity Index≥ 5). All consecutive patients with pSS (new or~     already known diagnosis) will be included, Anti-Ro/SSA IgE titers will be determined, the~     disease's features will be collected (including Eular Sjögren Syndrome Disease Activity~     Index/Eular Sjogren's Syndrome Patient Reported Index).~   "
43028|NCT03003559|"~     For AECOPD patients, only 8% patients ventilated by noninvasive and invasive positive~     pressure ventilation. Nasal cannula is the most common pattern of oxygen therapy in mild~     AECOPD. As a low flow oxygen therapy, nasal cannula has many disadvantages.Therefore, we~     design a randomized controlled trial(RCT)to explore whether HFNC would be better than nasal~     cannula to prevent the aggravation of respiratory failure and endotracheal intubation in mild~     AECOPD.~   "
43029|NCT03003546|"~     This phase I trial studies the best dose and side effects of paclitaxel albumin-stabilized~     nanoparticle formulation (nab-paclitaxel)/rituximab-coated nanoparticle AR160 in treating~     patients with B-cell non-Hodgkin lymphoma that has come back or is not responding to~     treatment. Nab-paclitaxel/rituximab-coated nanoparticle AR160 is a combination of paclitaxel~     albumin-stabilized nanoparticle formulation and rituximab. Drugs used in chemotherapy, such~     as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the~     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Monoclonal antibodies, such as rituximab, may interfere with~     the ability of tumor cells to grow and spread. Giving paclitaxel albumin-stabilized~     nanoparticle formulation and rituximab may work better in treating patients with B-cell~     non-Hodgkin lymphoma.~   "
43030|NCT03003533|"~     This clinical research study is being conducted by Spark Therapeutics, Inc. to determine the~     safety and efficacy of the factor VIII gene transfer treatment with SPK-8011 in individuals~     with hemophilia A.~   "
43033|NCT03003494|"~     The purpose of the study is to measure changes in physical functioning in chronic obstructive~     pulmonary disease (COPD) patients being treated with Spiolto® Respimat® after approximately 6~     weeks in routine clinical practice.~   "
43038|NCT03003429|"~     The heart rate variability (HRV) is a measure of the autonomic nervous system (ANS). In the~     model of anorexia nervosa, ANS is disturbed with mostly a predominance of activation of the~     parasympathetic nervous system and a decrease of the sympathetic system. Various explanations~     of this these dysfunctions are proposed in literature, mainly malnutrition, physical~     hyperactivity, anxiety, that are known characteristics of anorexia nervosa.~      The primary aim of this study is to evaluate correlation between ANS dysfunction and anxiety~     in anorexia nervosa.~      Other objectives of this study are firstly to evaluate correlation between ANS dysfunction~     and others parameters (weight, body mass index, depression, physical activity, purgative ou~     restrictive type, duration of disease, smoking) in anorexia nervosa and secondly to see if~     HRV is a predictive parameter of the evolution of anorexia nervosa.~   "
43039|NCT03003416|"~     This study will evaluate the efficacy of Ozurdex® as prescribed in clinical practice in~     France for the treatment of Diabetic Macular Edema (DME).~   "
43040|NCT03003403|"~     Up to 50% of obese patients are not interested in, or ready for, weight loss. Clinical~     practice guidelines clearly recommend that these patients avoid gaining weight. However,~     despite this clinical guideline, weight gain prevention interventions are not available in~     primary care practice. Balance is a pragmatic, randomized controlled effectiveness trial for~     weight gain prevention for patients within rural community health centers, using a digital~     health platform.~   "
43041|NCT03003390|"~     The purpose of this phase 2a, multi-center, randomized controlled study, is to explore the~     efficacy of early prophylaxis against catheter-associated deep venous thrombosis (CADVT) in~     critically ill children.~   "
43042|NCT03003377|"~     The study was designed to determine and compare the sevoflurane EC50 optimal concentration~     for laryngeal mask airway Supreme versus laryngeal mask airway ProSeal insertion during~     target-controlled infusion of remifentanil.~   "
43043|NCT03003364|"~     This is a phase I/IIa, randomized, double-blind, single-dose, placebo controlled, two-way~     crossover clinical trial in which 10 patients from 18 to 65 years of age affected with~     chronic traumatic spinal cord will enter the study with the objective to assess the safety~     and to obtain efficacy data in intrathecal administration of expanded Wharton's jelly~     mesenchymal stem cells.~   "
43044|NCT03003351|"~     This is a pro- and retrospective cohort study to evaluate the natural history and outcome of~     various treatment options of patients with fistula. At each clinical visit parameters~     describing activity of a fistula, potential underlying Crohn's disease, investigations as~     well as the current treatment will be entered into a database. Selected patients can also be~     contacted by phone in the form of a structured interview. Data will be analyzed to determine~     treatment outcomes, characterize the natural history as well as risk factors for~     complications of treatment and an unfavorable disease course. The same data will be obtained~     and analyzed retrospectively from patients who visited the clinic prior to January 2017.~   "
43045|NCT03003338|"~     This is a 1:1 randomized double-blind Placebo-controlled moncenter Phase IV study to~     investigate whether a successful interferon-free treatment of HCV-infection with~     ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) in combination with dasabuvir (DSV) improves~     the patients' attention ability as compared to placebo as measured with the Att Test Sum~     Score change from baseline to week 12. A total of 30 patients with non-cirrhotic genotype 1b~     HCV infection will be randomly assigned to receive 12 weeks verum followed by 12 weeks~     Placebo (arm A) versus 12 weeks Placebo followed by 12 weeks verum (arm B). Patients will be~     followed up for 48 weeks.~   "
43046|NCT03003325|"~     The Low-PV study is a multicenter, phase II, randomized trial aimed to assess whether the~     addition of Pegylated Proline-interferon-alpha-2b to the best therapeutic current strategy~     available based on phlebotomies and low dose acetylsalicylic acid (ASA) could improve the~     efficacy of treatment of patients with PV at low risk of thrombosis (younger than 60 years~     and without prior vascular events), in term of control of recommended level of hematocrit <~     45%, over a period of 12 months.~   "
43047|NCT03003312|"~     Objective:The aim of this study is to investigate the prevalence and associated factors of~     pediatric urolithiasis in Kashgar area in China.~      Methods: The investigators carry out a cross-sectional survey among children aged 0 to14~     years across Kashgar area in China. The participants are selected by a two-stage and~     clustered random sampling method. Participants are asked to undergo urinary tract~     ultrasonographic examinations, provided blood and urine samples to analyze. Their parents or~     guardians are asked to fill out the questionnaires. Children those who are found with any~     abnormalities of their urinary system by ulrtasonography will undergo a low-dose computed~     tomography (CT) to confirm the abnormalities. The end point of this study is to calculate the~     prevalence rate, distribution and associated factors of pediatric urolithiasis in Kashi area.~   "
43048|NCT03003299|"~     To assess the safety and effectiveness of the SAPIEN 3 (Edwards Lifesciences, Irvine,~     California) transcatheter heart valve in patients with a failing aortic bioprosthetic valve.~   "
43049|NCT03003286|"~     The purpose of this study is to determine whether a new treatment, Unstuck and On Target~     (UOT), works better, worse, or the same as the best treatment that is available now,~     Contingency Behavioral Management (CBM), for low income children with Autism Spectrum~     Disorder (ASD) or Attention Deficit Hyperactivity Disorder (ADHD).~   "
43050|NCT03003273|"~     Pediatric patients with febrile neutropenia coming to Department of Medical Oncology with low~     risk features (culture awaited), will be started on intravenous antibiotics (Inj~     Cefoperazone+ Sulbactam ± Amikacin) on outpatient basis. Those patients will be reassessed~     for randomization once they fulfill all inclusion criteria and get afebrile for at least 24~     hours. Antibiotics will be stopped in Arm-A and oral antibiotics, in place of intravenous~     antibiotics, will be started in Arm-B. The patients will be followed-up till ANC≥ 500, or~     reappearance of fever within follow-up of ≤ 10 days.~   "
43051|NCT03003260|"~     Rationale: IBS is the most common functional gastrointestinal disorder with a prevalence~     worldwide ranging from 9-23%. Complaints include abdominal discomfort or pain and altered~     bowel habits. Although the condition is not life-threatening, it strongly impairs quality of~     life and up to now there is no cure for IBS. It is assumed that IBS symptoms are related to a~     combination of altered gut motility and secretion, and visceral hypersensitivity. However,~     its primary cause still remains largely unknown. The endocannabinoid system, together with~     some functionally related receptors is among the biological targets considered promising for~     treatment. Modulation of the CB1 , CB2 and related receptors or enzymes of the~     endocannabinoid system in a broader sense by (endo) cannabinoids or (and) structurally~     related lipid mediators can influence motility, secretions and decrease hypersensitivity in~     the gut. Among the plant-derived cannabinoids or so called 'phytocannabinoids', cannabidiol~     (CBD) is of special interest as it has shown therapeutic potential in preclinical studies and~     a growing number of case-reports. CBD is a non-specific phytocannabinoid displaying a broad~     but weak receptor interaction profile. In contrast to the well-known THC from Cannabis~     sativa, CBD is not psychoactive and often also present in those Cannabis varieties that are~     not used for their psychoactive properties but for industrial (fibre) or food properties~     (oil, flour and seeds) instead. Based on preclinical studies and in vitro data we hypothesize~     that CBD might be able to relieve symptoms of IBS, including pain in patients with IBS. The~     chewing gum is to be taken 'on demand' and may have some additional perceived positive~     effects.~      Objective: To investigate whether the use of a CBD-containing preparation in the form of~     CanChew® chewing gum can contribute to a reduction of IBS symptoms and an improvement of~     perceived wellbeing in patients with IBS.~      Study design: A randomized, double-blind, cross-over trial of 8 weeks in total.~      Study population: Adults, aged 18-65, diagnosed according to the ROME III criteria with~     Irritable Bowel Syndrome.~      Intervention (if applicable): Patients will, in this cross-over study, receive a maximum 6~     chewing gums per day, either containing 50 mg of cannabidiol per chewing gum in case of the~     CanChew chewing gum, or a placebo chewing gum. This first intervention period will last 3~     weeks. Next, participants will undergo a one week wash-out and then switch intervention to~     either placebo or the CanChew chewing gum for another 3 weeks.~      Main study parameters/endpoints: The main study parameter is a change in pain reduction~     perception experienced and measured by the patient using VAS-scales before and after taking~     the chewing gum, to be recorded in a diary. Next to this a patient is asked to provide one~     VAS score for each completed week. Furthermore, the adequate relief will be measured every~     day. At the end of each week patients will also be asked (from their diary) whether they~     noticed a change in stool frequency or (and) experienced any side-effects. For the~     disease-related quality of life the IBS-QOL will be used. This questionnaire will be filled~     out in week 1, 4, 5, and 8.~   "
43052|NCT03003247|"~     Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris~   "
43065|NCT03003078|"~     To evaluate the safety of OncoSil™ in a patient population undergoing standard chemotherapy~     treatment for pancreatic cancer. This study has been designed to satisfy regulatory~     requirements.~      The clinical investigation will be conducted at approximately 15 sites in Australia, the~     United Kingdom and Europe (Belgium) involving 40 patients~   "
43053|NCT03003234|"~     Functional dyspepsia (FD) is an extremely common disorder of gastrointestinal function.~     Recently, impaired duodenal mucosal integrity was reported as a potential pathophysiological~     mechanism in FD. However, the factors controlling duodenal mucosal integrity remain unknown.~     In this study, we evaluated whether the luminal bile salt content could play a role in~     impaired duodenal permeability in FD.~      Duodenal biopsies were obtained from 25 healthy volunteers (HV) and 25 FD patients. Biopsies~     were mounted in Ussing chambers to measure transepithelial resistance (TEER) and paracellular~     permeability using fluorescein isothiocyanate dextran (FITC-dx4, MW 4kDa). Expression of bile~     acid-sensing receptors (TGR5, VDR, PXR, FXR and CAR) in duodenal biopsies was measured by~     western blot and real time RT-PCR. Immunohistochemistry was used to evaluate eosinophil and~     mastcell infiltration in duodenal biopsies of FD patients and HV. Duodenal fluid aspirates~     were collected at fixed time points during 1 hour in fasted state and 1.5 hours after a~     liquid meal (Nutridrink, 200ml). Concentration and composition of the bile salt pool~     (including glycocholic acid (GC), taurocholic acid (TC), glycochenodeoxycholic acid (GCDC),~     taurochenodeoxycholic acid (TCDC), glycodeoxycholic acid (GDC), taurodeoxycholic acid (TDC),~     glycoursodeoxycholic acid (GUDC) and tauroursodeoxycholic acid (TUDC)) in these aspirates was~     evaluated by liquid chromatography-mass spectrometry-selected ion monitoring analysis~     (LC-MS/MS).~   "
43054|NCT03003221|"~     Participation in routine dental care is a significant challenge for children with autism~     spectrum disorder (ASD) due to a variety of factors, including considerations related to ASD~     symptoms and associated anxiety and behavioral challenges. Lack of routine, effective dental~     care has contributed to a substantial unmet healthcare need for children with ASD, who are at~     increased risk for excessive plaque, caries, and oral infections.~      The purpose of this study is to test a parent-training intervention designed to improve home~     dental hygiene, compliance with dental office visits, and oral health outcomes in children~     with autism spectrum disorder. Families of children ages 3 to 13 years with an existing~     diagnosis of ASD will be recruited for participation. All families will receive the Autism~     Intervention Research Network on Physical Health (AIR-P) Dental Toolkit, which is designed to~     provide parents with guidance and information about dental care and support strategies for~     children with ASD. Some families will also participate in a 10-week behavioral~     parent-training intervention focused on improving home dental care and dental office visit~     experiences.~      The study has three primary aims: 1) To improve children's functional and behavioral~     compliance with home dental hygiene, 2) To improve children's oral health, and 3) To reduce~     child anxiety and improve compliance with dental visits.~   "
43055|NCT03003208|"~     Chronic obstructive pulmonary disease (COPD) is a common smoking-related lung disease.~     Patients with COPD are at increased risk of developing cardiovascular disease such as heart~     attacks and strokes. A simple measurement called arterial stiffness is a good assessment of~     how likely people are to have cardiovascular disease, both in healthy populations and those~     with COPD. Aortic Pulse wave velocity (aPWV) measures arterial stiffness,~      Pulmonary Rehabilitation (PR) - a 6 week supervised group exercise and education class - is~     an effective intervention in COPD to reduce symptoms, improve exercise performance and~     prevent exacerbations. However, the effect of PR on cardiovascular risk in COPD is~     controversial as two small positive studies suggested benefit and one larger study did not.~      Investigators have recently shown that cardiovascular risk is higher in those COPD patients~     who get the most infections (exacerbations). PR is an effective intervention for preventing~     COPD exacerbations. Logically, the exercise component would be expected to reduce~     cardiovascular risk too.~      Investigators want to identify which patients with COPD get cardiovascular benefit from a PR~     programme and why others do not. Investigators propose to measure aPWV before and after PR.~     Investigators will then classify participants as responders or non-responders defined as the~     presence or absence of a significant improvement in aPWV. Investigators will be collecting~     demographic and clinical information including daily physical activity level and how~     effective the PR has been to enable the investigators to identify the characteristics of~     patients who do, and do not achieve cardiovascular risk reduction in response to PR in COPD.~     This will inform on better design of PR programmes for people living with COPD.~   "
43056|NCT03003195|"~     The purpose of this research is to compare the effects of using a new experimental vaccine~     with standard treatment in treating metastatic cancer.~   "
43057|NCT03003182|"~     This prospective cohort study aims to establish prognostic models, to discover toxicity~     associated predictors and to validate randomized trials in clinical practice.~   "
43058|NCT03003169|"~     This is a prospective observational study, involving 550 mastectomies in Lorraine Institute~     of Oncology, to assess care patients management of ambulatory surgical compared to standard~     surgery procedure.~   "
43059|NCT03003156|"~     This trial attempts to investigate whether the dosage (frequency) has an effect on the~     treatment efficacy and cognitive outcomes of magnetic seizure therapy (MST) among~     schizophrenia patients. Half of the participants will be recruited to receive 25 Hz MST,~     while the other half will be recruited to 50 Hz MST.~   "
43060|NCT03003143|"~     Investigation of efficacy of vigabatrin in refractory autoimmune encephalitis patients~   "
43061|NCT03003130|"~     This is a randomized, split face, multicenter study to evaluate the efficacy and safety of~     Restylane Defyne compared to Restylane in correction of NLFs.~   "
43062|NCT03003117|"~     The purpose of this study is to conduct a randomized controlled trial among 800 socially~     disadvantaged pregnant women and their families to test the effectiveness of a~     multi-component home visitation nutrition program, compared to usual care, in promoting~     healthy feeding practices and growth in young children.~   "
43063|NCT03003104|"~     The study evaluates the safety, tolerability, and efficacy of DMT210 Gel, 5% when applied~     twice daily for 12 weeks in adult patients with moderate to severe acne rosacea. Half of~     participants will receive DMT210 Gel while the other half will receive vehicle control.~   "
43064|NCT03003091|"~     In patient education, the amount of information that is not proper with the individual~     patient, such as too much or too little, can increase anxiety to patient. Needs-based patient~     education has been developed to determine the proper amount of information and provide the~     education based on patient needs. This study aims to compare needs-based patient education to~     traditional patient education in how they affect preoperative anxiety and patient~     satisfaction.~   "
43067|NCT03003052|"~     This purpose of this database is to collect, store and use appropriately derived data from~     routine patient care in a specialist dental practice. Comprehensive observational data will~     be gathered, systematically organised and be continuously updated. This data will be used to~     evaluate treatment outcomes and identify areas for improvement. This will contribute to the~     existing evidence base to validate new and current clinical concepts in dentistry. Patient~     consent will be sought for this, and all data extracted from patient notes will be stored and~     used anonymously. Use of the Oral Health Impact Profile (OHIP) -14 questionnaire pre and post~     treatment will be used to assess patient satisfaction with outcomes.~   "
43068|NCT03003039|"~     The purpose of this study is the area under the curve (AUC) for GB241 and rituximab~     concentrations.~   "
43069|NCT03003026|"~     An assessor blinded multi-centre randomized controlled trial will be conducted in which 60~     participants will be randomized to either a novel task-specific approach to training bike~     skills or a parent-led home program comparison group. Baseline assessment will take place~     within 6 weeks prior to starting the intervention (T0) and outcomes will be assessed within a~     week following (T1); and at 12 - 14 weeks following (T2) the week long intervention. The~     primary outcome is attainment of individualised two-wheel bike specific goals at T1. All~     statistical analysis will be conducted on an intention-to-treat basis. Logistic regression~     will be used to assess the effect of providing the novel intervention compared to the~     parent-led home program on bike-specific goal attainment.~   "
43070|NCT03003013|"~     Effect of Biphasic Bone Graft Material (BGM) in combination with autologous platelet-rich~     fibrin (PRF) on bone regeneration in an odontogenic maxillary cyst: a randomized clinical~     trial~   "
43071|NCT03003000|"~     To assess the efficacy and safety of a 400 mg ibuprofen/100 mg caffeine tablet in comparison~     to a 400 mg ibuprofen tablet for the treatment of acute lower back or neck pain. To assess~     the safety and tolerability of a 400 mg ibuprofen/100 mg caffeine tablet in comparison to a~     400 mg ibuprofen tablet and a placebo tablet.~   "
43072|NCT03002987|"~     In a cluster randomized design it will be investigated whether teaching local leaders how to~     implement active pregnancy policy results in less sickness absence among their pregnant~     employees. Further it will be investigated to what extent Active pregnancy policy is~     implemented at the departments and whether it results in higher sense of security and~     wellbeing among the pregnant employee. Finally the cost and benefits of the intervention will~     be analyzed.~   "
43073|NCT03002974|"~     The purpose of this study is to evaluate how anakinra relieves pain for patients with acute~     gout that cannot take non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine. The~     patients will be divided in different treatment groups to compare anakinra to the available~     drug triamcinolone.~   "
43074|NCT03002961|"~     A multi-center, open-label, single ascending dose study to enroll opioid dependent~     treatment-seeking subjects. Subjects to be enrolled into 3 cohorts receiving low, medium and~     high doses of depot buprenorphine. A fourth cohort will be enrolled to evaluate the PK of~     RBP-6000 after receiving suboxone tablets for 7 days.~   "
43075|NCT03002948|"~     Topography and location of clitoris and its parts may affect the orgasm~   "
43076|NCT03002935|"~     This is an open-label, Phase I study of the bioavailability and safety of BPM31510~     administered orally in healthy subjects dosed 3 times daily for 14 days. The last study dose~     is administered on Day 15 (one morning dose only). The study will consist of 25 subjects.~   "
43077|NCT03002922|"~     To visually evaluate the retention of coverage of the Test Product(s) (TP) on the face after~     exercise compared to the full coverage observed prior to exercise~   "
43078|NCT03002909|"~     the investigators aim is to investigate the effect of continuous preperitoneal bupivacaine~     wound infiltration versus epidural analgesia on the inflammatory cytokines response after~     abdominal cancer surgery~   "
43079|NCT03002896|"~     The proposed project is a pilot randomized control trial of the Pep-Pal (Psychoeducation and~     Skills Based Intervention) versus a treatment as usual control group. A total of 120~     caregivers; 40 caregivers of patients with HSCT (Hematopoietic Stem Cell Transplantation), 40~     caregivers of patients enrolled in phase I oncology trials, and 40 caregivers of patients~     with advanced cancer (Stage IV, solid tumor) will be enrolled in this study. The~     investigators do not expect different outcomes from these three groups, rather these~     populations are selected to optimize recruitment within a short time frame. The caregivers~     will be randomized to either treatment as usual or Pep-Pal intervention.~   "
43080|NCT03002883|"~     Community colleges have 45% of the nation's undergraduates and have a higher smoking~     prevalence rate than 4-year colleges. California's community colleges comprise the nation's~     largest higher education system, and Sacramento has the second largest community college~     district. As more colleges are encouraged to become smoke and tobacco-free campuses, smokers~     enrolled at community college campuses need greater support. However, community colleges may~     lack the student health clinic resources that 4-year colleges have for students who live on~     campus. Little evidence to date demonstrates effective interventions for smokers on community~     college campuses.~      This pilot study seeks to demonstrate the feasibility and promising outcomes of two cessation~     interventions, compared with usual care on a community college campus. The first intervention~     was based on a promising model of brief motivational interviewing delivered by peer~     educators, developed by the community lead Breathe California of Sacramento-Emigrant Trails~     (BCSET) through the Sacramento Taking Action Against Tobacco Dependence (STAND) project. The~     second intervention was based on direct enrollment into the California Smokers' Helpline,~     which has demonstrated utility for promoting smoking cessation among young adults with low~     socioeconomic status. Usual care consisted of students going to the student health center for~     smoking cessation assistance.~   "
43081|NCT03002870|"~     The purpose of this study is to collect and analyze data on the characteristics of women who~     are seeking treatment for endometriosis, suspected endometriosis, pain and/or infertility as~     part of their standard medical care. Data collected will contribute to the development of~     guidelines for the surgical management of endometriosis. In addition, specimens will be~     collected for future testing regarding diagnosing, and/or staging of endometriosis, or~     suspected endometriosis, pain and infertility.~   "
46700|NCT02955602|"~     An 8-week, dose ranging, open label, randomized, Phase 2 study with a 44-week extension, to~     evaluate the safety and efficacy of MBX-8025 in subjects with Primary Biliary Cholangitis~     (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA)~   "
43082|NCT03002857|"~     The most used airway management strategies are different types of supraglottic airway devices~     (SAD) for transurethral resection of bladder and ureteroscopy in urological surgery .~     Classical laryngeal mask airway (LMA-C) and I-Gel SADs are being used already. The aim of~     this study was to evaluate and compare the performance of a new type of SAD the Baska Mask®~     with I-gel and LMA-C regarding their insertion times, durations, perioperative complications~     and effects on hemodynamic parameters, peak airway pressures (Paw) and airway plato pressures~     in urological surgery as well.~   "
43083|NCT03002844|"~     BIM deletion polymorphism might be associated with a poor clinical response to EGFR-TKIs in~     patients who had NSCLC with EGFR mutations. In the study, the investigators want to use~     EGFR-TKI with/without chemotherapy as first line treatment in stage IIIB/IV NSCLC patients~     with both EGFR mutation and BIM deletion polymorphism.~   "
43084|NCT03002831|"~     The purpose of this study is to determine whether Cytokine induced killer cells combined~     chemotherapy is more effective in the treatment of advanced Pancreatic Cancer.~   "
43085|NCT03002818|"~     This is an observational, prospective, open-label, single-arm, multicenter, real-life study~     designed to observe the impact of paritaprevir/ritonavir/ombitasvir with dasabuvir regimen~     (Viekirax®/Exviera®, 3D regimen) on total daytime physical activity and fatigue in~     participants with Hepatitis C Virus (HCV) genotype 1 (GT1).~   "
43086|NCT03002805|"~     This study evaluates the combination of CBT-1® and doxorubicin for the treatment of~     metastatic, unresectable sarcoma in patients who have progressed after treatment with~     150mg/m2 or less of doxorubicin. Participants will receive CBT-1® on days 1-7 of each 21-day~     cycle, as well as doxorubicin on days 5 and 6.~   "
43087|NCT03002792|"~     The purpose of this study is to investigate whether early expose to general anaesthesia will~     influence neurodevelopment.~   "
43088|NCT03002779|"~     The purpose of the study is to determine the routes of excretion for JNJ-53718678 and its~     metabolites, to explore the metabolic pathways of JNJ-53718678, and to determine the chemical~     structure of predominant metabolites in healthy adult male participants after a single oral~     dose of 500 milligram (mg) 14C-JNJ-53718678.~   "
43089|NCT03002766|"~     By this non-randomized prospective study, it's evaluated the outcome of patients underwent~     BCS for DCIS at whom an established score system to address adjuvant therapies have been~     prospectively applied, according to the wideness of free margins.~      Between March 2000 and April 2006, 224 patients were enrolled and followed within the study.~   "
43090|NCT03002753|"~     The purpose of this study is to assess and compare the overall efficacy and differential~     effects of detached mindfulness and cognitive restructuring in the treatment of patients with~     obsessive-compulsive disorder.~   "
43091|NCT03002740|"~     In a population of patients with non-valvular atrial fibrillation (NVAF), and treated with~     oral anticoagulants (OAC) in routine clinical practice in England, this study will describe~     patients treated with each OAC, and to estimate and compare event rates of treatment~     discontinuation, bleeding, and healthcare resource utilisation (HCRU) across OAC treatments.~   "
43092|NCT03002727|"~     Microsatellite instability is more common in colorectal cancer ( CRC) young patient which is~     associated with good prognosis and is considered as a predictor for good response to~     preoperative chemoradiotherapy. Counting of ( cluster of differentiation) CD 133 +ve cells~     ,as a marker for enrichment with colorectal cancer stem cells ,is considered as a prognostic~     marker for poor survival and predictor for radio-resistance. Correlation between~     microsatellite status ( MS) and CD133 count has not yet studied especially in young patients~     with rectosigmoid cancer. So the investigators hypothesize that there is correlation between~     microsatellite status, CD133+ve cells count , occurrence of CRC in young patients and~     resistance to standard treatment regimen. Improvement of response to treatment and choice of~     the best regime to avoid non beneficial treatment modality are the goal of this study.~   "
43093|NCT03002714|"~     The purpose of this study is to determine and compare the effects of two sessions of~     resistance exercise in blood pressure reactivity to a mental stress test in older~     hypertensive women.~   "
43094|NCT03002701|"~     Delirium is a common disorder in Intensive Care Unit (ICU) patients and is associated with~     serious short- and long-term consequences. This study focuses on a program of standardized~     nursing and physical therapy interventions to prevent delirium in the ICU, and determines the~     effect of the program on the number of delirium-coma-free days in 28 days and several~     secondary outcomes in a multicenter randomized controlled trial.~   "
43095|NCT03002688|"~     The purpose is to gauge the patients' level of comfort and anxiety for sequential cataract~     surgeries to assess if the second experience of cataract surgery differs from the initial~     experience.~   "
43096|NCT03002675|"~     The obesity epidemic has led to a enormous increase in the prevalence of type 2 diabetes~     mellitus (T2D), dyslipidemia and cardiovascular events. Particularly South Asians, who~     comprise 1/5 of the world population, are at increased risk of developing a disadvantageous~     metabolic phenotype and these diseases. Moreover, T2D occurs at a younger age and at a lower~     BMI when compared to white Caucasians. Recent research has shown that South Asians not only~     have a lower energy expenditure than their Caucasian counterparts, but also less active brown~     adipose tissue (BAT).~      For some time, it has been known that adult humans have active BAT. This metabolic tissue~     produces heat by combusting triglycerides, in contrast to white adipose tissue, which stores~     this form of energy. It has been shown that activation of BAT has a positive effect on whole~     body metabolism, via increasing energy expenditure and improving glucose- and lipid~     metabolism. For this matter, BAT has been proposed as a major key player in energy~     homeostasis, which may be implemented in the current combat against the obesity epidemic.~     Aside from cold exposure, more research focuses on pharmacological activation of BAT.~      Glucagon-like peptide 1 (GLP-1) is an incretin hormone which is produced by intestinal~     L-cells and upon food intake stimulates insulin secretion by pancreatic beta cells. The GLP-1~     analogue Exenatide is a currently much used antidiabetic drug to reduce hyperglycemia via~     this aforementioned mechanism. Beyond its blood glucose-improving effects, Exenatide has also~     shown to lower body weight and improve dyslipidemia in T2D patients. Elucidation of the~     underlying mechanism of these beneficial effects is highly relevant.~      Recent preclinical research in our group has shown that central activation of the GLP-1~     receptor through exenatide increases BAT activity and thereby contributes to weight loss and~     improvement of dyslipidemia. The aim of this research project is to investigate whether~     exenatide is also able to activate BAT and increase resting energy expenditure, thereby~     improving glucose- and lipid metabolism and reducing fat mass and body weight in humans.~     Moreover, the investigators aim to validate the MRI scan as a novel way to measure BAT~     activity. The investigators hope that these forthcoming findings lead to the discovery of new~     treatment strategies against obesity.~   "
43097|NCT03002662|"~     During colonoscopy, body mass index, waist circumference and waist / hip ratio is the~     relationship between the cecal intubation difficulty aims to define.~   "
43098|NCT03002649|"~     The purpose of this study is to obtain preliminary data regarding the safety and efficacy of~     Janus kinase (JAK) inhibitor, tofacitinib, in adults with active, treatment-refractory~     dermatomyositis.~   "
43099|NCT03002636|"~     900 parturient who underwent CS under general anesthesia(GA) , intraspinal anesthesia~     included epidural anesthesia(EA) and combined spinal-epidural anesthesia(CSEA), which were~     divided into 3 groups: Morbid Obesity group (n=300) with body mass index (BMI) >40 kg/m2 ,~     severe Obesity group (n=300) with 30 kg/m2≤BMI ≤40 kg/m2 and non-Obesity group(n=300) with~     BMI<30 kg/m2. Findings Between January 1, 2013 and September 30, 2016, a total of 1000 women~     met inclusion criteria and 900 women received allocated intervention. All patients were~     divided into three groups: Morbid Obesity group(n=300), Severe Obesity group(n=300) and~     non-Obesity group(n=300) according to body mass index (BMI) >40 kg/m2, 30 kg/m2≤BMI ≤40 kg/m2~     and BMI<30 kg/m2.900 patients completed the protocol and related data were analysed.~   "
43100|NCT03002623|"~     Background:~      The thyroid is a gland at the base of the throat. Thyroid cancer is a disease that people get~     when abnormal cells begin to grow in this gland. Researchers believe a new drug called~     CUDC-907 may be able to help people with thyroid cancer that has spread or has gotten worse.~      Objective:~      To see if CUDC-907 will shrink tumors in people with advanced thyroid cancer.~      Eligibility:~      People at least 18 years old who have been diagnosed with locally advanced and metastatic~     thyroid cancer.~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Blood and urine tests~      Electrocardiogram (ECG) heart test.~      Review of their symptoms and how they perform normal activities~      A scan will be performed. Some will have a computed tomographic scan (CT) that takes pictures~     of the body using a small amount of radiation. Some will have magnetic resonance imaging~     (MRI) that uses a magnetic field to take pictures.~      Bone scan (some participants)~      FDG PET scan to produce a tumor image.~      A sample of their tumor from a previous surgery. They may have a biopsy of their tumor if a~     tumor sample is not available from a previous surgery.~      Participants will be given CUDC-907 in tablet form. They will take it by mouth once a day for~     5 days, then take 2 days off, each week.~      While taking the study drug, participants will have study visits that repeat the screening~     tests.~      After they stop treatment, participants will have 3 follow-up visits over a year. They will~     repeat some tests. Then participants will be contacted by phone or e-mail every 6 months....~   "
43101|NCT03002610|"~     The objective of this study is to evaluate the efficacy of infographics, compared to standard~     PLS and scientific abstract format, in presenting information, in terms of understanding and~     remembering research results by physicians.~   "
43102|NCT03002597|"~     The BrainPort vision device is a visual prosthetic designed for those who are blind. It~     enables perception of visual information using the tongue and camera system as a paired~     substitute for the eye. Visual information is collected from a video camera and translated~     into a gentle vibration that is presented to the subject on the tongue. With training users~     perceive shape, size, location and motion of objects in their environment. It is a~     functional, non-surgical device developed to demonstrate as an aid to the visually impaired.~      The aim of this proposal is to evaluate a non-surgical visual prosthetic (BrainPort vision~     device) that enables the blind to appreciate their immediate surroundings and determine the~     way the brain interprets the information. Our goal is to determine if the device can be used~     in a pediatric population by measuring the subjects' improvement over baseline in any of the~     following areas: light detection, light localization, movement perception, and standardized~     object recognition tasks after use of the BrainPort.~   "
43103|NCT03002584|"~     Objective: To confirm the psychometrics properties of the Intestinal Gas Questionnaire (IGQ)~     in subjects with Irritable Bowel Syndrome (IBS) diagnosis and General population both~     complaining of Gas-Related Symptoms (GRS).~      IGQ has been developed previously simultaneously in UK English, French and Spanish through~     qualitative research with subject interviews. The conceptual framework of the IGQ assesses~     both GRS and their impact on daily life. Similar concepts were identified for both subjects~     with IBS diagnosis and general population and complaining of gas-related symptoms.~      The IGQ consists of a 24-hour recall symptom diary assessing 7 gas-related symptoms (17~     items) and a 7-day recall questionnaire which assesses the impact of those symptoms (26~     items)~   "
43104|NCT03002571|"~     Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic~     Dermatitis in Pediatric and Adult Subjects~   "
43105|NCT03002558|"~     Objectives:~      Main objective: To assess the impact of obstructive sleep apnea (OSA) and its treatment on~     cardiovascular outcomes (morbidity and mortality) in patients with resistant hypertension~     (RH).~      Secondary objectives: i) to identify the subclinical organ damage profile at baseline and its~     association with OSA, and to identify if long term blood pressure control and number of~     antihypertensive drugs needed is different depending on OSA diagnosis and its treatment; ii)~     to identify epigenetic profiles and clinical, biological and polygraphic variables with a~     predictive value for cardiovascular outcomes in RH patients with OSA; iii) to validate the~     HIPARCO-SCORE tool in men in an independent cohort and elaborate a new tool to be used in~     women; and iv) to perform a cost-effectiveness analysis to evaluate the impact of OSA~     diagnosis and treatment in patients with RH.~      Methodology: Prospective cohort study. 1,371 RH patients will be recruited. Ambulatory blood~     pressure monitoring (ABPM), socio-demographic, clinical, OSA-related, biochemical and~     subclinical organ damage variables and biological samples at baseline will be collected from~     all the subjects included. A sleep study will be performed in all the subjects at the study~     inclusion date. Subsequently, the OSA subjects will be managed as per local standard~     practice. Follow-up variables will be annually collected (including blood samples). On the~     basis of OSA and its treatment, three cohorts of RH subjects will be defined: control~     (non-OSA), OSA-treated and OSA nontreated.~   "
43106|NCT03002545|"~     This study aims to determine how a 12-week magnesium supplementation with 400 mg magnesium~     from organic magnesium citrate affects blood glucose control and insulin resistance within~     patients with type 2 diabetes (HbA1c> 6%) and how the expression of certain Mg-sensitive~     transporting genes is affected .~   "
43107|NCT03002532|"~     Based on evidence that radiation-induced damage to the hippocampus plays a considerable role~     in neurocognitive decline after cranial irradiation, hippocampal-sparing whole brain~     radiation therapy (HS-WBRT) has been proposed. This study will investigate the neurocognitive~     function and prognosis between HS-WBRT and conventional WBRT for the treatment of brain~     metastases from breast cancer.~   "
43108|NCT03002519|"~     This study aims to evaluate the safety of intramuscular (IM) administration of PLX-R18 in~     subjects with incomplete hematopoietic recovery following HCT.~   "
43109|NCT03002506|"~     This study will help provide information about how patients with burn handle two antibiotics~     (ceftolozane and tazobactam) and use that information to guide dosing recommendations for~     these patients. The 12 patients who complete the study will receive a single dose of 3 grams~     ceftolozane/tazobactam intravenously. We will collect blood and urine samples to determine~     how much of each antibiotic is in the body and urine at various times over a 24 hour period.~     This information will be used with previously published information from microbiology~     laboratories to perform simulations that will provide recommendations on optimal dosing~     recommendations of these antibiotics in patients with burns.~   "
43110|NCT03002493|"~     The primary objective of this study was to assess the effect of cytochrome P450 3A4 enzyme~     (CYP3A4) induction by rifampicin on the pharmacokinetics (PK) of eribulin mesylate following~     intravenous (IV) administration in participants with advanced solid tumors. The secondary~     objectives of this study were to assess the safety of eribulin mesylate when co-administered~     with rifampicin and assess the safety and activity of eribulin mesylate as a single agent.~   "
43111|NCT03002480|"~     This pilot study will investigate the use of thromboelastograph (TEG) to determine the~     primary bypassing agent for the management of bleeding in children and adults severe~     hemophilia A patients with inhibitors.~      The study will evaluate the TEG profile for each of the available bypassing agents (FEIBA and~     rFVIIa) in each participating patient, which will then determine which agent provides the~     most robust clot formation as measured by the TEG. This study will consist of screening visit~     and 2-4 pharmacokinetic studies to determine the best bypassing agent based on the TEG~     results. Patients will then be assigned that bypassing agent and dose for the treatment of~     their bleeding episodes (Prophylaxis or On-demand). Each patient will be then followed for a~     period of 6 months to monitor short-term safety of those patients whose bypassing agent was~     modified.~   "
43112|NCT03002467|"~     The Investigator postulate that the use of PESI in addition to routine clinical practice, as~     opposed to routine clinical practice based on clinical judgment alone, will help physicians~     to correctly identify PE patients at low-risk of adverse outcomes. Considered that low-risk~     patients could benefit from a short hospital stay, aim of this study is to demonstrate that~     the use of PESI will lead physicians to discharge these patients earlier, thus reducing the~     duration of hospital stay of PE patients (primary outcome).~      Outpatients diagnosed with PE at the emergency department (ED) and admitted to participating~     units represent the target population~      As the availability of DOACs may influence the duration of hospital stay, the secondary~     objectives of the present study are:~        1. to demonstrate that a shorter hospital stay for low-risk PE patients (independently on~          the method used to identify them) will reduce the incidence of hospital-associated~          complications and improve patients satisfaction and quality of life, without increasing~          the incidence of PE-related complications~        2. to demonstrate that the use of PESI, as opposed to clinical judgment alone, will be~          associated with a greater proportion of patients discharged early (< 72 hours from ED~          admission) or treated entirely at home (< 24 hours from ED admission).~        3. to demonstrate that the use of DOACs will reduce the duration of hospital stay of PE~          patients~        4. to demonstrate that the use of DOACs, as opposed to standard treatment, will be~          associated with a greater proportion of patients discharged early (< 72 hours from ED~          admission) or treated entirely at home (< 24 hours from ED admission).~   "
43113|NCT03002454|"~     A non-fission sourced, solvent generator produced 99mTc intravenous injection, as 99mTc -MDP,~     is to be used as a bone scan diagnostic radiopharmaceutical for assessment of bone pathology~     using the same oncologic indications as nuclear reactor sourced 99mTc, as 99mTc-MDP.~   "
43114|NCT03002441|"~     The purpose of this randomized trial is to compare same-day cervical preparation using~     Dilapan-S™ plus buccal misoprostol to overnight cervical preparation using Dilapan-S™ before~     D&E at 16.0 to 20.0 weeks.~      Primary objective: To compare D&E operative time. We hypothesize that same-day Dilapan-S™~     plus buccal misoprostol is non-inferior to overnight Dilapan-S™ with respect to operative~     time.~      Secondary objectives: To compare treatment groups for the following: Pre-operative cervical~     dilation; need for mechanical dilation and ease of dilation if required; ability to complete~     D&E without further cervical preparation; ease of D&E; complications; pain; side effects;~     patient and provider satisfaction.~   "
43115|NCT03002428|"~     The purpose of this study is to compare the effects of two teriparatide products, PF708 and~     Forteo, in patients with osteoporosis.~   "
43116|NCT03002415|"~     Acute dehydration in the elderly is a well-known clinical condition, although situations that~     lead to chronic dehydration in the elderly may be quite frequent, but they are poorly~     studied. Metabolic changes in body water homeostasis can influence and provide chronic~     dehydration status as reduced sensitivity to thirst, antidiuretic hormone and renal inability~     to concentrate urine and the presence of chronic diseases and the use of polypharmacy may~     also predispose states of chronic dehydration. Due to these facts, a study to detect the~     existence of chronic dehydration states in a population of elderly people is highly~     justifiable. In addition, understanding whether increased water intake, improving chronic~     dehydration, may improve renal function in this population seems to be of great value, since~     it is a simple and inexpensive intervention and, if confirmed, it can be taken to~     institutions, by family members and health promoters who care for and cohabit with elderly~     individuals.~      Our main objective is to evaluate the effect of stimulated and calculated water intake (per~     kg of patient weight) on the state of hydration and renal function in a population of elderly~     individuals. It is also within the scope of this project to evaluate the presence of chronic~     dehydration in elderly patients as well as in a subgroup of diabetic patients, and to compare~     different methods of evaluation of renal function. Design: Clinical trial Randomized for the~     main objective and cross-sectional study for secondary objectives.~      The principal hypothesis is that guided water intake improve renal function in elderly~     patients.~   "
43117|NCT03002402|"~     The purpose of the proposed study are to explore changes in sleep and asthma outcomes from~     baseline to post-treatment in adults with asthma and comorbid insomnia who underwent~     Internet-based cognitive-behavioral treatment for insomnia (CBT-I).~   "
43999|NCT02990884|"~     Ilioinguinal / iliohyogogastric nerve blocks; It is frequently used for analgesia and~     anesthesia in inguinal region surgeons. However, 95% of these surgeons are under general~     anesthesia. aim of this study; Intra-operative anesthesia and analgesia effects of~     ilioinguinal / iliohyogogastric nerve block supported by ketamine sedation only.~   "
43118|NCT03002389|"~     Hyper polarized xenon-129 MRI (HXe MRI) is a unique imaging test which can detect how air is~     flowing in and out of lungs and how oxygen can move from inhaled air into the blood. Chronic~     Obstructive Pulmonary Disease (COPD) is a disease in which patients develop narrowing of~     airways, thus, having difficulties breathing air in and out their lungs and also damaging the~     lung tissues which patients need to move oxygen from the air into blood.~      In this study, two drugs which are already approved by FDA (Anoro and Arnuity) will be~     administered to patients who are already known to have COPD. While patients are being treated~     with these two drugs (one drug at a time over a month), lung health by using usual testing~     methods (CT scan of the lung, pulmonary function test, and blood test) will be assessed in~     addition to HXe MRI.~      The goal of this study is to prove that the HXe MRI is an excellent imaging test to show the~     state of lung health among COPD patients and also to obtain new informations on how lung~     health changes with drugs that are already approved by US FDA. This work is anticipated to~     help develop HXe MRI as a new clinical test which can guide how to treat patients with COPD~     and if new therapies can improve lung health of patients with COPD.~   "
43119|NCT03002376|"~     This study is being conducted to compare the relationship of patient response to treatment to~     changes in tumor environment.~   "
43120|NCT03002363|"~     The purpose of the current study is to determine if pre-exposure through video modeling will~     enhance testing compliance in a population of children who are receiving a diagnostic~     evaluation for Autism.~   "
43121|NCT03002350|"~     Distant metastasis of cancer remains the major cause of cancer death. One of the evidence is~     that some rare cells shed from primary tumor exist in the circulation of cancer patients,~     which has been proven to be related to cancer relapse and distant metastasis. The number of~     circulating tumor cells (CTCs) or the expression status of specific marker(s) on them also~     correlated with the disease prognosis and treatment effects, which might change the decision~     of treatments. In recent years, as specific disruptive genes were discovered, such as~     epidermal growth factor receptor (EGFR) in non-small cell lung cancer,Kirsten rat sarcoma~     (KRAS) in colorectal cancer, the response rate to treatment, disease control and survival~     have been much improved. However, the molecular information obtained from cancer tissue~     depends on repeated biopsies, which is very risky and invasive to cancer patients. By means~     of the advances of CTCs sampling technique with genetic analysis, repeated follow-up for~     specific gene profiles is possible. However, the protocol has not been well-established and~     mature, even the correlation between primary cancer tissue and CTCs remains unknown. To~     tackle the problems above, the aims of the project is to isolate high-purity CTCs by the~     optically induced dielectrophoresis (ODEP)-based device or other cell sorting techniques and~     transfer to next-generation sequencing (NGS) analysis for specific disruptive genes. In the~     first year of the project, the investigator will testify and stabilize the platform utilizing~     healthy donors' blood and cancer cell lines and adjust the detailed experiment conditions. In~     the following year, the investigator will enroll newly diagnosed metastatic cancer patients~     with the disruptive gene mutation(s) and follow up the events under gene-based therapy.~     Comparison of NGS information between cancer tissue and CTCs will be also made as one of the~     major endpoints. In brief, the investigator expect the study could establish a practical~     method to get genetic information, to reduce the risk of re-biopsy and to achieve the~     ultimate goal of precision medicine.~   "
43122|NCT03002337|"~     This study's aims are to examine the effects of yoga and aromatherapy on women's stress and~     immune function during pregnancy.~   "
43123|NCT03002324|"~     This study is the second phase of a trial examining decision making about vaccines. For this~     phase of this study, the researchers will conduct a 3-arm randomized trial to compare the~     current Centers for Disease Control and Prevention (CDC) human papillomavirus (HPV) message,~     a new cervical cancer focused message developed by the study team, and a non-vaccine related~     control passage among parents of adolescent females. The goal of the trial will be to~     determine if the new cervical cancer framed message has an increased impact on intent to have~     daughters receive the HPV vaccine over the trial period as compared to the current CDC~     message used in the field. Additionally, the researchers will examine the impact both the CDC~     message and the new message individually have on intent to vaccinate when compared to the~     non-vaccine related control message.~      The participant's vaccine beliefs and intent to vaccinate will be assessed through an online~     survey at baseline. Two weeks later, participants will be randomized to view one of the three~     messages: the current CDC message, the cervical cancer framed message, or a non-vaccine~     related control message. Immediately afterwards, vaccine beliefs and intent to vaccinate will~     be assessed to determine the impact of the message.~   "
43124|NCT03002311|"~     This study's purpose is to test the effects of an electronic health intervention platform~     developed by Epharmix, which features two-way SMS text messages and phone calls intended to~     improve clinical outcomes compared to the standard of care. The investigators hypothesize~     that this system can improve frequency and quality of data gathering across various~     specialties, leading to expedited provider intervention and improved health outcomes.~   "
43125|NCT03002298|"~     With the growing accessibility of computer-assisted technology, one option for rehabilitation~     programs for individuals with Duchenne muscular dystrophy (DMD) is the use of virtual reality~     environments to enhance motor practice. Thus, it is important to examine whether performance~     improvements in the virtual environment generalize to the natural environment. To examine~     this issue, we had 64 individuals, 32 of which were individuals with DMD and 32 were~     typically developing individuals. The groups practiced two coincidence timing tasks. In the~     more tangible button-press task, the individuals were required to 'intercept' a falling~     virtual object at the moment it reached the interception point by pressing a key on the~     computer. In the more abstract task, they were instructed to 'intercept' the virtual object~     by making a hand movement in a virtual environment using a webcam.~   "
43126|NCT03002285|"~     Introduction: Cerebral palsy (CP) is a non-progressive disorder in the brain which makes the~     control and execution of movements difficult. One of the possible ways to analyze motor~     control in these individuals could be through analysis of movement speed and accuracy.~     Objective: To verify the speed-accuracy trade-off in individuals with CP. Method: 96~     individuals were evaluated, 48 with CP and 48 with typical development (TD), matched by age~     and sex. The software used was the Fitts' Reciprocal Aiming Task v.1.0 (Horizontal),~     performed on a computer using an external optical mouse, with progressive indices of~     difficulty (IDs): ID2, ID4a and ID4b. Each index of difficulty was performed three times and~     the total time/touches captured.~   "
43127|NCT03002272|"~     In this observational study, the investigators will enroll subjects who underwent TAVR or~     SAVR more than 3 years ago. Clinical and procedural data from the implant/surgery will be~     collected, alongside clinical and echocardiographic data from subsequent follow-up visits.~   "
46701|NCT02955589|"~     Phase 2b, open-label, non-randomized, single arm study to evaluate the safety, and efficacy~     of HBI-8000 40 mg BIW in patients with relapsed or refractory ATL (R/R ATL)~   "
43128|NCT03002259|"~     Background. Numerous studies have investigated high-dose corticosteroids in cardiac surgery,~     but with mixed results leading to ongoing variations in practice around the world. The~     Dexamethasone for Cardiac Surgery-II Trial (DECS-II) is a study comparing high-dose~     dexamethasone with placebo in patients undergoing cardiac surgery.~      Methods. We discuss the rationale for conducting DECS-II, a 2800-patient, pragmatic,~     multicenter, assessor-blinded, randomized trial in cardiac surgery, and the features of the~     DECS-II study design (objectives, end points, target population, balanced clusters based on~     practice preference with post-randomization consent, treatments, patient follow-up and~     analysis).~      Conclusions. The DECS-II Trial will use a novel, efficient trial design to evaluate whether~     high-dose dexamethasone has a patient-centered benefit of enhancing recovery and increasing~     the number of days at home after cardiac surgery.~   "
43129|NCT03002246|"~     This trial is a collaborative study between 4 sites worldwide. A total of 600 research~     subjects will be enrolled. We will investigate the validity of using 5D Limb Volume software~     to improve on estimated fetal weight predictions over a broad range of gestational ages. The~     purpose is to compare the accuracy and precision of birth weight predictions based on this~     new technology as compared to the current 2D birth weight prediction models.~   "
43130|NCT03002233|"~     This study is a 2-part study.~      Part A is a single-dose, open-label study design to determine the PK, safety and tolerability~     of 5 μg TRK-820 oral administration in subjects with end-stage renal disease (ESRD) who~     require hemodialysis.~      Part B is a multiple dose, open-label study design to determine the PK, PD, safety and~     tolerability of multiple doses in subjects with ESRD who require hemodialysis with refractory~     uremic pruritus (UP). Each subject will receive 3 doses of TRK-820 (2.5, 5 and 10 μg).~   "
43131|NCT03002220|"~     Radium-223 is indicated for the treatment of patients with mCRPC with symptomatic bone~     metastases and no known visceral metastatic disease. However, very few data have been~     reported in patients with mCRPC who are asymptomatic or mildly symptomatic. Recently, results~     from an International Expanded Access Program have also suggested a benefit of radium-223 in~     asymptomatic patients with mCRPC. In addition, the mechanism of action of radium-223 should~     not be correlated with the presence/absence of the AR-V7 mutation, although this issue has~     not yet been evaluated.~      The aim of this study is to assess the efficacy of radium-223 in asymptomatic patients with~     mCRPC, and to establish the association between AR-V7 status and radium-223 activity.~   "
43132|NCT03002207|"~     In this prospective study the investigators seek to evaluate clinical outcomes after~     repairing the defect of intervertebral disc with autologous BMSC/gelatin sponge during~     microendoscopic discectomy for participants of lumbar disc herniation.~   "
43133|NCT03002194|"~     This study will measure the difference in skin elasticity in females only before and after~     treatment with radiofrequency and pulsed electromagnetic field therapy.~   "
43134|NCT03002181|"~     The effect of a 70 minute Pain Neurophysiology Education session on Sport Therapy Students~     Knowledge, Attitudes and Clinical Behaviour Towards Athletes With Chronic Pain~   "
43135|NCT03002168|"~     The Investigator hypothesizes that the currently used dose of dietary ingredient~     alpha-cyclodextrin (α-CD) will result in greater loss of dietary fat in the stool compared~     with placebo. The proposed studies will address the degree to which α-CD increases dietary~     fat loss.~      The Investigator will conduct the study and analyze the samples at Mayo Clinic in Rochester,~     Minnesota.~   "
43136|NCT03002155|"~     People with diabetes are at risk for life altering complications, including diabetic foot~     ulcers. To heal a diabetic foot ulcer, people are often required to refrain from bearing~     weight on their affected limb for months. These long periods of non-weight bearing can result~     in severe physical deconditioning, putting these individuals at risk for further health~     decline. The goal of this pilot, randomized controlled trial is to evaluate the effects of a~     seated exercise program on clinically meaningful outcomes in people with diabetic foot~     ulcers. The long-term aim of this research is to improve overall health and quality of life~     in people with complications from diabetes.~   "
43137|NCT03002142|"~     Alzheimer disease is a neurodegenerative disease. Recent studies suggest that subjects with~     hearing loss are more likely to develop Alzheimer's disease. Hearing loss can be consecutive~     to presbycusis and/or to central auditory dysfunction.~      Standard audiometric measures with pure tone and speech intelligibility allow the diagnosis~     of presbycusis. However, to demonstrate central auditory dysfunction, specific audiometric~     tests as noisy and/or dichotic tests, are needed.~      Actually, no consensus exists to investigate hearing loss in people with Alzheimer's disease;~     therefore hearing loss may be an early manifestation of Alzheimer's disease. Until now,~     investigations and clinical procedure related to the diagnosis of Alzheimer's disease ignored~     the hearing ability of the patient. However, the major part of care management and~     investigations implies the patient's communication ability with caregivers. Hearing loss may~     be one of the most unrecognized deficit in subjects with Alzheimer's disease. Auditory~     rehabilitation with hearing aids could benefit to the patient to decrease cognitive decline~     but this management must be investigate during longitudinal studies in order to demonstrate~     their efficiency and need to be compared with a placebo.~   "
43138|NCT03002129|"~     In this study, the investigators propose to investigate a novel technique for fluid~     responsiveness prediction. It is based on the occurrence of an extra systole, which induces a~     preload variation: Extra systoles are comprised by, first, the premature/ectopic beat with~     decreased cardiac preload, then, the post-ectopic beat with moderately increased preload.~      Consequently, the post ectopic beat is associated with a Frank-Starling curve right shift but~     is otherwise a normal sinus beat. As such, the post-ectopic beat elucidates and predicts the~     hemodynamic effect of increasing preload, i.e. giving fluids~   "
43151|NCT03001960|"~     TAVI is increasingly adopted as standard treatment for many subgroups of patients with aortic~     stenosis. However, due to a lack of data there is yet no TAVI-specific guidance regarding the~     optimum periinterventional drug regimen.~      The study evaluates the effect of dual antiplatelet pretreatment on periinterventional~     embolic cerebral lesions and bleeding complications in patients undergoing transfemoral~     aortic valve implantation (TF-TAVI).~   "
44470|NCT02984722|"~     The aim of our study is to compare the different effects of 6 months treatment with~     extended-release metformin and immediate-release metformin on clinical, endocrine and~     metabolic parameters in women affected by polycystic ovary syndrome. We also evaluate~     gastrointestinal disorders associated with the two different compouds.~   "
43139|NCT03002116|"~     Diagnosis of vascular involvement in diabetic foot disease remains challenging. Differential~     diagnosis between pure neuropathic or neuro-ischemic diabetic foot requires a combination of~     clinical examination, medical history and ankle-brachial index (ABI) measurement, which is~     considered the gold standard non-invasive modality for limb ischemia diagnosis. However, in~     diabetic patients with suspected arterial ischemia resulting in tissue loss (critical limb~     ischemia; CLI), false negative ABI results are frequent due to Monckeberg medial sclerosis~     producing incompressible vessels, while clinical signs are subjective and not accurate in~     posing definite diagnosis of CLI.~      The investigators conducted a proof of concept study of the feasibility of microwave~     radiometry thermometry for non-invasive diagnosis of CLI in diabetic patients with tissue~     loss.~   "
43140|NCT03002103|"~     This is a prospective, multicenter, open-label, randomized, and controlled trial to test the~     superiority of EndoTAG®-1 in combination with paclitaxel and gemcitabine versus paclitaxel in~     combination with gemcitabine.~      An independent data safety monitoring board (DSMB) will be established to decide on the~     recommended dose (RD) of EndoTAG®-1, paclitaxel and gemcitabine to be used throughout the~     trial and to monitor the patients' safety and treatment efficacy data~   "
43141|NCT03002090|"~     Iron deficiency is known to negatively impact physical performance, attention, and time spent~     doing physical activity. As a result, an iron deficient person must expend more energy to~     complete the same amount of work as someone who is healthy. Another interesting relationship~     has been observed between exercise training and iron status in that women who participate in~     exercise training often have higher rates of iron deficiency than sedentary women. ID is~     commonly treated using daily iron supplementation. However, it is currently unknown whether~     participating in regular exercise somehow impacts the effectiveness of iron supplementation.~     Iron deficient women who participate in exercise programs may potentially benefit less from~     iron supplementation than those who do not. Another common treatment for the symptoms of iron~     deficiency is the traditional Chinese herbal treatment, Ba-Zhen-Ke-Li (BZKL). While studies~     have shown that BZKL impacts expression of some iron-related proteins and increases endurance~     performance in rats, no studies have examined the efficacy of BZKL in improving iron markers~     or physical performance in humans. This study will compare the efficacy of BZKL in improving~     iron status and physical performance with that of ferrous sulfate supplementation. The~     Cornell research team will achieve these objectives in collaboration with colleagues at~     Kunming Medical University (KMU) in Kunming, China. A double-blind, randomized, placebo~     controlled study will be conducted by a Cornell graduate student at KMU. The subjects will be~     healthy women, age 18-26 years, attending KMU. Blood samples will be collected and analyzed~     for measures of iron).~      Subjects will be randomly assigned to receive 50 mg of ferrous sulfate (10 mg of elemental~     iron), 6mg of BZKL, or an identical placebo pill twice daily for 8 weeks. Subjects will be~     further randomly sub-divided to receive aerobic exercise training or no training during the~     8-week supplementation period. At weeks 4 and 8, subjects will perform the same series of~     tests as was performed at baseline. The investigators hypothesize that: 1. the women who~     train and received iron will have smaller improvements in iron status than those who do not~     train 2. The women who receive iron and train will have greater improvements in physical~     performance than those who train and do not receive iron, and 3. The women who receive BZKL~     will improve their iron status or physical performance more than those who receive placebo.~   "
43142|NCT03002077|"~     This study will evaluate the long-term safety and tolerability of rapastinel as an adjunctive~     to antidepressant therapy (ADT) in patients with major depressive disorder (MDD).~   "
43143|NCT03002064|"~     This is a phase III clinical trial to compare the efficacy of docetaxel plus cisplatin versus~     5-Fu plus cisplatin in the first line chemotherapy for advanced or metastatic esophageal~     squamous carcinoma patients.~   "
43144|NCT03002051|"~     To evaluate clinical efficacy and safety of a novel lumen-apposing FCSEMS for EUS-guided~     transenteric drainage of PFC or of biliary tree including GB~   "
43145|NCT03002038|"~     The purpose of this study is to compare annual relapse rate, expanded disability status~     scale, and side effects of azathioprine and rituximab in patients with neuromyelitis optica~     spectrum disorder during a one year follow up through a randomized clinical trial.~   "
43146|NCT03002025|"~     The primary purpose of this study is to assess the safety, tolerability, and pharmacokinetics~     (PK) following single-dose subcutaneous (SC) injection of JNJ-64304500 in healthy Japanese~     male participants.~   "
43147|NCT03002012|"~     Cryptococcal meningitis or Crypto is a life threatening fungal infection around the brain~     that requires hospitalization for treatment for 14 days and then continued therapy. Crypto~     causes 15-20% of HIV/AIDS-related deaths worldwide. However, this infection can be detected~     before one develops symptoms and becomes ill. People can be screened for infection by a blood~     test to detect cryptococcal antigen, (called CrAg), which is part of the fungus, in blood.~     The World Health Organization and over 22 countries worldwide recommend CrAg screening of all~     persons with advanced AIDS entering or re-entering into HIV care.~      However, it is not known how best to treat people with cryptococcal antigen in their blood,~     who don't otherwise yet have symptoms of infection around their brain. If no treatment is~     given, almost all people will develop infection of the brain and/or die. International~     guidelines suggest using both HIV medicines and an anti-fungal medicine, called fluconazole,~     to treat this early infection. However, despite this treatment approximately 1 in 4 people~     may get sick and/or die.~      Researchers have recently discovered another medicine that may work against the Cryptococcus~     fungus. This medicine is called Sertraline, and it is actually a medicine that has been used~     for more than 25 years to treat depression (sadness). Sertraline is one of the most commonly~     used medicines worldwide.~      The purpose of this research clinical trial is to determine if standard fluconazole~     antifungal therapy plus a high dose of Sertraline, will be better than standard fluconazole~     therapy alone for treating early disseminated cryptococcal infection in persons who are~     asymptomatic and do not yet have infection of the brain (i.e. meningitis).~      This study seeks to test if Sertraline will improve survival through 6-months. Prior studies~     have shown that >90% of those who survive 6-months will survive >5 years.~   "
43148|NCT03001999|"~     The focus of this study is to examine the feasibility, acceptability, and preliminary impact~     of a customized, combined positive psychology and motivational interviewing (PP-MI) health~     behavior intervention in a group of patients with type 2 diabetes (T2D).~   "
43149|NCT03001986|"~     Enterovirus 71 (EV71), a major pathogen causing hand-foot-and-mouth disease (HFMD) worldwide,~     is a member of the Human Enterovirus species A, family Picornaviridae. Its infection~     occasionally leads to severe diseases and death, with central nervous system (CNS) damage.~      Recently, except of inactivated vaccine, several EV71 vaccine candidates have been evaluated~     in animals but no final results of clinical trials, such as attenuated vaccine, subunit~     vaccine.~      A formalin-inactivated EV71 vaccine (Human Diploid cell, KMB-17 Cell) has been finished phase~     I, II and III clinical trials and licensed by SFDA in China at Dec. 3, 2015. Based on the~     results of clinical trials, the protective efficacy of inactivated EV71 vaccine is 97%~     against HFMD caused by EV71. The phase IV clinical trial has been carried out from July 2016.~     The purpose of phase IVb is to evaluated the safety and efficacy of the inactive EV71 vaccine~     in large scale population of Chinese children (from 6 to 71 months old) in Hubei Province,~     China.~   "
43150|NCT03001973|"~     The investigators are registering LN patients at recruited hospitals and developing a LN~     database in China. Patients will be follow-up every year, and both baseline and follow-up~     information will be entered into the registration system.~   "
43167|NCT03001752|"~     This is a three-armed randomized controlled clinical trial aiming the estimation of~     dimensional alveolar bone changes after insertion of post-extraction implants through 3~     different surgical techniques: open flap, open flap and grafting, flapless.~   "
43152|NCT03001947|"~     The investigators are registering all biopsy-proven primary IgA nephropathy (IgAN) patients~     at recruited hospitals and developing a IgAN database in China. Patients will be follow-up~     every one year, and both baseline and follow-up information will be entered into the~     registration system. All-cause and cardiovascular mortality and a composite renal outcome of~     doubling of serum creatinine and end stage renal failure (ESRD, defined as initiation of~     dialysis or kidney transplantation) of IgAN patients will be compared using the IgAN~     database.~   "
43153|NCT03001934|"~     The investigators are registering all nephrotic syndrome (NS) patients regardless of the~     primary causes and developing a NS database in China. Patients will be followed-up and both~     baseline and follow-up information will be recorded in the registration system. The treatment~     response, longitudinal changes of renal function, renal survival, patient survival, infection~     events and acute kidney injury etc, will be analyzed using the NS database.~   "
43154|NCT03001921|"~     The investigators are registering all HD patients at recruited hospitals and developing a HD~     database in China. Patients will be follow-up every 3 months, and both baseline and follow-up~     information will be entered into the registration system. The patient survival, technical~     survival, patency rate of access, quality of life and residual renal function for HD patients~     will be compared using the HD database.~   "
43155|NCT03001908|"~     Pain pressure measurements, fine wire EMG and real time imaging ultrasound will be used to~     determine the relationships between motion, pain perception, and mobility in the glenohumeral~     joint. Muscle activity, joint motion, and pain will be measured pre-post randomized~     interventions to determine the response to various physical therapy techniques.~   "
43156|NCT03001895|"~     Prostate specific membrane antigen (PSMA) is a unique membrane bound glycoprotein, which is~     overexpressed manifold on prostate cancer cells and is well-characterized as an imaging~     biomarker of prostate cancer. Positron emission tomography / computer tomography (PET/CT) is~     a nuclear medicine procedure based on the measurement of positron emission from radiolabeled~     tracer molecules. 18F-DCFPyL is a tracer for prostate cancer PET imaging which binds to PSMA.~     The strength of functional imaging methods is in distinguishing tissues according to~     metabolism rather than structure. Studies have shown that PET/CT imaging with 18F-DCFPyL can~     detect prostate cancer lesions with excellent contrast and a high detection rate even when~     the level of prostate specific antigen is low.~      The objective of this study is to evaluate if the patient-wide SUVmax on 18F-DCFPyL PET/CT in~     locoregional and metastatic prostate cancer correlates with histopathologic Gleason score at~     initial biopsy. It is hypothesized that SUVmax will correlate positively with Gleason score.~     This is of interest because non-invasive risk stratification may be possible in the future.~   "
43157|NCT03001882|"~     The purpose of this study is to explore the possible links between participant~     characteristics and their cancer, with how effective the combination of nivolumab with~     ipilimumab is, in participants with Stage IV or recurrent Non-Small Cell Lung Cancer (NSCLC).~   "
43158|NCT03001869|"~     The objectives of this study are to replicate the safety and efficacy of 68Ga-PSMA PET/CT and~     as a diagnostic and decision making tool in the management prostate cancer patients.The~     primary endpoints of the study are the incidence of adverse events (AE) in the study~     population up to 7 days following the scan, and the sensitivity and specificity of 68Ga-PSMA~     PET/CT vs CT on a per-patient and per-lesion basis.~   "
43159|NCT03001856|"~     This study was conducted to demonstrate the equivalence of wound outcomes between the~     interrupted oblique intradermal suture (OIS) and conventional interrupted intradermal suture~     (IS) methods~   "
43160|NCT03001843|"~     This study will help to determine if investigators can minimize narcotic use in laparoscopic~     gastric bypass patients while maintaining adequate pain control. This will allow~     investigators to minimize the negative side effects of narcotics which is a goal in this~     population.~   "
43161|NCT03001830|"~     The GO-8 study focuses on assessing safety and efficacy of gene therapy for patients with~     severe haemophilia A~   "
43162|NCT03001817|"~     The purpose of this study is to evaluate the efficacy and safety of K-877 in adult patients~     with SHTG.~   "
43163|NCT03001804|"~     The aim of this non-interventional study is to collect primarily the percentage of patients~     who receive the full dose of dexamethasone (40 mg orally once daily on days 1, 8, 15 and 22~     of the repetitive 28-day cycles, 20 mg in> 75 year old patients) and in the registered~     indication under practice conditions.~   "
43164|NCT03001791|"~     The aim of the RCT is to analyse clinical and histopathological particularities for~     excisional biopsies of fibrous hyperplasia in the buccal mucosa performed with Er:YAG laser,~     CO2 laser and scalpel. The primary outcome parameter is to evaluate the thermal damage zone~     on the excised specimens. Secondary parameters are time of surgery, intraoperative bleeding,~     the need for additional electrocoagulation or sutures and patient's postsurgical perception~     of pain, other postsurgical effects and use of analgesics.~   "
43165|NCT03001778|"~     Physical activity (PA) has physical, emotional, and cognitive benefits for seniors (e.g.,~     increased strength and balance, reduced frailty, fewer falls, improved brain function, lower~     mortality risk), yet many seniors have limited access to exercise options due to numerous~     barriers (e.g., transportation concerns, financial costs, fear of injury/falling). This~     project will overcome common exercise barriers by creating an interactive web-enabled TV~     program (i.e., Smart TV), adapted from research-based PA protocols, to be implemented in an~     Independent Living Facility (ILF) setting. A web-based prototype will be developed, and ILF~     residents and administrators will be able to create, use, and evaluate a customizable~     exercise program tailored to the individual's preferred type of exercise, intensity, and~     duration.~   "
43166|NCT03001765|"~     Hypothesis:~      Patients that were previously discharged from the emergency department with a subsequent~     non-diagnostic 30 day external patch monitor for suspected arrhythmia will benefit from early~     Reveal LINQ™ Insertable Cardiac Monitoring System placement.~      Primary Study Objectives:~      To evaluate the outcome of an intensive monitoring strategy (patients with a negative 30 day~     SEEQ™ Mobile Cardiac Telemetry (MCT) System result are purposed over for a Reveal LINQ™~     Insertable Cardiac Monitoring System) in patients with suspected but no previously documented~     arrhythmias that result in a clinically actionable event.~   "
44496|NCT02984384|"~     The purpose of this study is to investigate the effectiveness of Low Molecular Weight Heparin~     (LMWH) compared to Aspirin in preventing death and clinically important pulmonary blood clots~     in patients who sustain trauma.~   "
43168|NCT03001739|"~     Aortic dissection (AD) aneurysm is a common catastrophic aortic disease in clinical setting.~     Conservative therapy of heart rate and blood pressure control in the acute phase is the~     essential treatment as guidelines recommended. Nevertheless, there is no unanimous optimal~     target for blood pressure in patients with AD so far. The American Heart Association and the~     Canadian Cardiovascular Society recommend the blood pressure should be controlled to lower~     than 140/90mmHg, while for patients with diabetes or chronic renal failure, the blood~     pressure target should be no less than 130/80 mmHg. Recently, the Japanese Circulation~     Society recommended that the blood pressure should be controlled to no less than 130mmHg.~     However, there was few large-scale, randomized, controlled studies reported on the effect of~     different blood pressure control levels on the prognosis of patients with AD. Hence, the~     intensive control of blood pressure to <120 mmHg, compared to <140 mmHg, may improve the~     patients' outcome. Thus, in this study, the effect of intensive blood pressure control~     (<120mmHg) with conventional blood pressure control (<140mmHg) on the prognosis of ABAD~     patients will be compared, and to identify the therapeutic efficacy of intensive blood~     pressure control on the ABAD patients.~   "
43169|NCT03001726|"~     Investigators assessed the effectiveness of conversional gastrectomy compared with~     chemotherapy alone following docetaxel, oxalipaltin and S1 therapy for advanced gastric~     cancer with a single non-curable factor.~   "
43170|NCT03001713|"~     This project aims to reduce disparities in cardiovascular disease (CVD) risk factor control~     and in rates of heart attacks and strokes among the low-income, racially / ethnically diverse~     Americans who receive primary care at safety net community health centers (CHCs). To achieve~     this important objective, the investigators will adapt a successful clinical decision support~     (CDS) system currently used in CVD care at several large, integrated health care systems, to~     meet the patient needs and workflow processes of 60 CHCs. The investigators will determine if~     use of this CDS improves CVD care, reduces disparities in CVD care and outcomes, and~     increases patient engagement in CVD treatment choices, in CHCs. Results of this randomized~     trial will help accelerate the translation of major investments in health informatics systems~     into substantial clinical benefits for large numbers of high-risk, low-income patients.~     Results will also provide a template for CVD care improvement that can be spread to other~     CHCs and extended to other clinical conditions.~   "
43171|NCT03001700|"~     To assess preliminary safety and efficacy of the Serranator™ Alto PTA Serration Balloon~     Catheter in subjects with atherosclerotic peripheral artery disease of the superficial~     femoral and popliteal arteries.~   "
43172|NCT03001687|"~     Acute inflammation induced by surgery and sepsis is complicated by the development of~     iron-restricted anemia due to the up-regulation of hepcidin. Excess hepcidin causes~     intracellular sequestration of iron, decreasing its availability for erythropoiesis. Hepcidin~     might be a potential target to reduce transfusion requirements in surgical and sepsis~     patients. Vitamin D supplementation might constitute a novel strategy to modulate the~     hepcidin-ferroportin-iron axis. Up to now, there are no data regarding the possibility that~     by using vitamin D supplementation in surgical and septic shock patients, the physicians~     could ameliorate anemia and, hence, reduce transfusion requirements. Aim: to conduct a~     randomised controlled trial to determine the impact of high-dose vitamin D enteral~     supplementation on serum hepcidin levels and transfusion requirements after major abdominal~     surgery and in septic shock patients.~   "
43173|NCT03001674|"~     The primary objective of this study is to develop normative hemodynamic data (means and~     standard deviations) for the intra-aortic balloon pump (IABP) using pressure-volume loop and~     3D-echocardiographic analyses.~   "
43174|NCT03001661|"~     Induction of labour (where labour is started artificially) is traditionally carried out with~     a range of different drugs or by surgery (rupturing the membranes or 'waters'). Dilapan-S is~     a mechanical device, known as an osmotic cervical dilator, which provides an alternative to~     drugs or surgery. Thin rods of an absorbent material (no active drug present) are inserted~     into the neck of the womb (cervix) and, as they absorb fluid, they swell and mimic the~     natural process of 'ripening' (or preparing) the cervix. This initial process is important~     before contractions begin. Unlike drugs, Dilapan-S does not cause premature contractions~     that, when too frequent, may cause the baby to become distressed. The project will compare~     cervical ripening using Dilapan-S with the standard use prostaglandin drug. Women with a~     single pregnancy, who require induction of labour, and who are not considered high risk, will~     be invited to participate. Investigators hope to recruit 860 women from UK maternity units~     over 2 years. Participants will have an equal chance of being randomised to the drug, which~     is standard practice, or the cervical dilator. The speed in which labour commences, the mode~     of delivery and any side effects will be compared. Importantly, investigators shall also~     assess patient satisfaction and anxiety during the induction process, by asking participants~     to complete a short questionnaire about their experience before they go home after having~     their baby. If osmotic dilators are effective investigators expect NICE to consider them an~     option alongside other cervical ripening methods.~   "
43175|NCT03001648|"~     This is a single centre retrospective study in repeated implantation failure patients: < 39~     years old, at least 4 D3 good quality embryos or 2 good quality blastocysts transferred~     without implantation, absence of known causes of implantation failures (uterine malformation,~     thrombophilia, severe male factor, uncontrolled thyroid disfunction, autoimmune disease).~      Patients scheduled for PGS underwent one or more stimulation cycles (oocyte or blastocyst~     banking) in order to maximize chances of embryo transfer. PGS cycles are analyzed globally.~     Aditionally, PGS cycles with a single stimulation cycle are analyzed in comparison to~     standard IVF cycles.~   "
43176|NCT03001635|"~     60 patients admitted to this ICCU at the Sheba medical Center will be randomly divided in to~     2 groups. one group will receive the conventional treatment while the second group will~     receive the conventional treatment plus oxytocin infusion for 48 hours. all participants will~     undergo echo and cMRI during hospitalization.~   "
43214|NCT03001141|"~     This is a prospective, multicenter, non-randomized registry/observational study. The study~     will enroll up to 200 patients with successful St. Jude Medical (SJM) Cardiac~     Resynchronization Therapy (CRT) MP device implant from up to 10 centers.~   "
43215|NCT03001128|"~     The purpose of this study is to collect information about what happens when people pause, or~     temporarily stop taking, ART, and to collect blood samples from these people at frequent~     intervals. We will also study the safety of pausing ART under close observation.~   "
43177|NCT03001622|"~     The trial enrolls patients with moderate to severe Hidradenitis Suppurativa (HS). The primary~     goal of the trial is to evaluate the safety and tolerability of IFX-1 administered over 8~     weeks in these patients. In addition the trial aims to characterize the pharmacokinetics and~     pharmacodynamics of IFX-1 as well as to generate preliminary data on the efficacy of IFX-1 on~     clinical endpoints (e.g., Hidradenitis Suppurativa Clinical Response (HiSCR), Dermatology~     Life Quality Index (DLQI), Visual Analog Scale (VAS) for disease, VAS for pain, Hidradenitis~     Suppurativa - Physician's Global Assessment (HS-PGA), Modified Sartorius Score (mSS)).~   "
43178|NCT03001609|"~     The purpose of this study is to investigate Pharmacokinetics parameters of a single dose~     [14C] AC0010 in male Patients With Advanced NSCLC.~   "
43179|NCT03001596|"~     The purpose of this study is to evaluate the outcomes of neoadjuvant chemoradiotherapy versus~     neoadjuvant chemotherapy followed by minimally invasive esophagectomy on patients with~     locally advanced resectable esophageal squamous cell carcinoma(cT3-4aN0-1M0).~   "
43180|NCT03001583|"~     Clinical trial comparing two health education programs for obese patients in order to achieve~     a substantial and beneficial weight loss, using mediterranean diet. Patients will be~     allocated to two groups, one will receive education in diet and lifestyle, and the other one~     the same plus cooking lessons. The intervention period is for 6 months with monthly visits~     and phone and email contacts in between. An extension observation period of two years is also~     planned with 6 months contacts in our clinic, also with phone and email contact available.~   "
43181|NCT03001570|"~     Nowadays the association between radiotherapy and the anti- Epidermal Growth Factor Receptor~     (anti-EGFR) monoclonal antibody Cetuximab represents a valid option in the treatment of head~     and neck locally advanced squamous neoplasm and, particularly, of oropharynx carcinoma. Up to~     date we have only indirect comparison with the standard curative treatment (i.e. concurrent~     radiochemotherapy) and the preliminary data show equivalent efficacy of both regimens. For~     this reason, concurrent Cetuximab and radiotherapy is administered in patients not eligible~     to chemoradiotherapy. The introduction of Cetuximab has been associated to new kind of~     toxicities, especially cutaneous, that have increasingly reported.~      The aim of our study is to improve the toxicity/benefit ratio in patients receiving~     concurrent radiotherapy and cetuximab for locally advanced head and neck neoplasm. Hence,~     this improvement could be achieved by modulating radiation therapy dose per fraction~     following Cetuximab pharmacokinetics.~   "
43182|NCT03001557|"~     This study will be conducted to determine the dose response of lemborexant on the change from~     baseline in actigraphy-derived Sleep Efficiency and Wake Efficiency during the last week of 4~     weeks of treatment in participants with Irregular Sleep-Wake Rhythm Disorder and Alzheimer's~     disease dementia.~   "
43183|NCT03001544|"~     This study is designed to determine the safety, pharmacokinetics and pharmacodynamics of a~     single intravenous dose of TS23 in healthy adults.~   "
43184|NCT03001531|"~     Preconditioning of regional skin is known to reduce post surgery complications due to~     increased perfusion and better skin condition. The aim of this study is to prove that local~     heating through a standardized device in patients with spinal cord injury induces no burnings~     or other relevant side effects. The investigators expect an increased regional perfusion,~     temperature and redness.~   "
43185|NCT03001518|"~     The goal of this pilot study is to evaluate and describe the immunologic and overall outcomes~     of subjects who undergo routine pancreatectomy with or without irreversible electroporation~     (IRE) for pancreatic cancer. Immunologic markers in the blood will be measured at several~     time points before and after surgery to determine if surgical approach is associated with~     different immunologic responses. Secondary outcomes will include mortality and morbidity;~     operative time; blood loss and transfusion requirements; and oncologic outcomes such as:~     margin status, lymph node harvest, disease-free survival, and overall survival. Analysis of~     immune response will help the investigator determine whether to expand the pilot into a~     larger study.~   "
43186|NCT03001505|"~     This is an observational, prospective and retrospective registry of patients with pancreatic~     cancer treated in Duke University Health System, which will examine patient and treatment~     effects on cancer outcomes.~   "
43187|NCT03001492|"~     Elevation of serum progesterone on the day of ovulation triggering in IVF/ICSI cycles is~     suggested to be associated with compromized outcomes. Others found that this rise didnot~     affect the IVF/ICSI outcomes. It is still controversal if premature luteinization would~     affect the IVF/ICSI outcomes.~   "
43188|NCT03001479|"~     Breast milk is readily accepted as the ideal source of nutrition for almost all infants,~     including premature or very low birth weight infants. However, these high-risk infants~     require the addition of fortifiers to their milk in order to achieve sufficient levels of~     calories, vitamins, and minerals for adequate growth. We are currently using a liquid human~     milk fortifier which does not provide sufficient protein intake, requiring addition of a~     liquid protein supplement. A new product has been released which provides sufficient protein~     in the liquid HMF, without the acidification seen in previous products.~      This is a prospective, randomized noninferiority study comparing the safety and efficacy of~     the new HMF with additional protein to our current standard of adding additional protein~     supplementation on top of the HMF.~   "
43189|NCT03001466|"~     Cataract is the leading cause of vision loss and blindness in the world,surgery is the only~     available option to correct the problem and the major reasons for low cataract surgical rates~     include low demand because of fear of surgery, high cost of surgery and poor visual results~     but new research raises the hope that someday, cataracts could be cured with simple eye~     drops. This is the first report for preparing urea-loaded NPs eye drops for cataract therapy.~     Enhancement of the urea efficacy is accomplished by using polymeric NPs based on the~     amphiphilic block copolymer Pluronic®F-127 (PF) which is a hydrophilic nontoxic copolymer~     widely used as a pharmaceutical excipient for its stabilizing properties and capability to~     increase the solubility.~   "
43216|NCT03001115|"~     The objective of this study is to evaluate the safety profile of Adalimumab for Hidradenitis~     Suppurativa (HS) participants in normal medical practice.~   "
43217|NCT03001102|"~     Clinical trial for prevention, randomized, controlled, blinded, parallel, with three arms~     which purpose is verify the effects of nursing intervention preoperative bathing with 4%~     chlorhexidine gluconate, 10% Povidone iodine (PVPI) and soap without antiseptic, for the~     prevention of surgical site infection (SSI) in patients undergoing hip arthroplasty.~   "
43190|NCT03001453|"~     The purpose of this study is to compare two medications currently injected intra-operatively~     to help decrease pain after surgery in patients undergoing a primary total hip replacement~     (THR). The two medications are Exparel® (bupivacaine liposome injectable suspension) plus~     bupivacaine with epinephrine versus bupivacaine with epinephrine. This study is looking to~     see if one medication works better than the other in managing post-operative pain after THR.~     The study hypothesis is that Exparel® plus bupivacaine with epinephrine will demonstrate~     better pain management in THR patients post-operatively. Both medications are FDA-approved~     for post-operative analgesia.~   "
43191|NCT03001440|"~     Branded bupropion hydrochloride products including ZYBAN and WELLBUTRIN range are approved~     for the treatment of smoking cessation and depressive disorders respectively. The Risk~     Evaluation and Mitigation Strategy (REMS) for ZYBAN was initially approved in 2010 and~     consists of a Medication Guide and a timetable for REMS assessments submission at 18 months,~     3 years and 7 years from the date of initial approval of REMS. The present study is a 7-year~     REMS assessment to evaluate subjects' understanding of the potential serious risk of~     neuropsychiatric adverse events associated with the use of ZYBAN, WELLBUTRIN, WELLBUTRIN SR,~     and WELLBUTRIN XL. The assessment will be a 20-minutes Knowledge, Attitudes and Behavior~     (KAB) survey and will be conducted among approximately 125 subjects currently using or who~     have filled a prescription for a branded bupropion product for smoking cessation within the 6~     months prior to survey administration. ZYBAN, WELLBUTRIN, WELLBUTRIN SR, and WELLBUTRIN XL~     are registered trade marks of the GSK group of companies.~   "
43192|NCT03001427|"~     This application proposes to extend an ongoing NHLBI clinical trial (NCT02342808) examining~     the efficacy of a lifestyle intervention combining the Dietary Approaches to Stop~     Hypertension (DASH) diet with caloric restriction and aerobic exercise to lower and control~     BP in individuals with RH. In the parent trial, participants with RH will be randomized to~     either: (1) a 4-month adjunctive lifestyle intervention designed to lower BP through exercise~     and diet (C-LIFE), or; (2) a standardized education and physician advice (SEPA) control~     condition.~      The current protocol will collect additional assessments of neurocognition (executive~     function, processing speed, and memory), endothelial function (brachial artery flow-mediated~     dilation), and cerebrovascular reserve (a measure of prefrontal cortex tissue oxygenation) in~     120 participants at baseline, following completion of the 4-month intervention, and again~     after one year, in order to examine neurocognitive improvements and their potential~     mediators.~   "
43193|NCT03001414|"~     The SAPPHIRE clinical trial seeks to establish the efficacy and safety of repeated monthly~     dosing of autologous EPCs transfected with human eNOS (heNOS) in patients with symptomatic~     severe PAH on available PAH-targeted medical therapy.~   "
43194|NCT03001401|"~     The proposed study seeks to compare visual acuity, tomographic outcomes, biomechanical~     changes and inflammatory profile of normal eyes (matched for age, refraction and corneal~     thickness) undergoing iDesign and SMILE procedure. The hypothesis is that iDesign may deliver~     equivalent or better clinical outcomes than SMILE, by removing less tissue and correcting for~     higher order aberrations.~   "
43195|NCT03001388|"~     To determine if transient elastography (TE), when combined with ultrasound (US) pattern~     characterization can improve the prediction of progression to a nodular pattern on US.~      To confirm the feasibility of obtaining TE measurements in children with Cystic Fibrosis (CF)~     To prospectively assess whether TE data are associated with conventional laboratory markers~     of hepatic fibrosis To determine the variability of TE measurements taken at different sites~     in the same patient~   "
43196|NCT03001375|"~     This retrospective cohort study conducted on 140 patients who underwent laparoscopic anterior~     resection for upper rectal cancer in the period from May 2011 to November 2015, comparison~     will be done on splenic flexure mobilization excluding .~   "
43197|NCT03001362|"~     Patients with histologically proven adenocarcinoma of the rectum will receive pelvic~     radiotherapy to a dose of 45Gy in 25 fractions with a tumor boost to a dose of 9Gy in 5~     fractions (thus total of 54Gy/30Fx to the primary tumor), combined with radio sensitizing~     chemotherapy. Patients will then be closely monitored, through endoscopy and imaging, for~     response to treatment and relapse. Salvage oncologic surgery to be offered if there is~     failure to achieve complete clinical response or in the event of a loco regional relapse.~   "
43198|NCT03001349|"~     Any time the words you, your, I, or me appear, it is meant to apply to the potential~     participant.~      The goal of this clinical research study is to use 68GA-DOTATOC instead of the~     standard-of-care 111-In-pentetreotide as a tracer chemical during PET/CT scans for diagnosing~     neuroendocrine tumors. A tracer is injected into your bloodstream to help the study doctor~     see possible tumors.~      This is an investigational study. 68GA-DOTATOC is an investigational PET/CT tracer. It is not~     FDA approved as a PET/CT tracer.~      Up to 100 patients will take part in this study. All will be enrolled at MD Anderson.~   "
43199|NCT03001336|"~     The purpose of this study is to investigate the potential association between thyroid~     function and diabetes complications in the elderly subjects with type 2 diabetes mellitus~     (T2DM).~   "
43200|NCT03001323|"~     Given the longer half life of insulin degludec compared to glargine /levemir ,investigators~     believe that insulin degludec will reduce the rate of recurrent DKA. The investigator will~     randomize participants to control and intervention group. Control group will receive~     Lantus/Levemir and intervention group will receive degludec. The investigators will call~     participants monthly and see them in the clinic every three months.The investigators will~     follow them for 1 year and evaluate if there will be a difference in rate of DKA in between~     these two groups.~   "
43201|NCT03001310|"~     A clinical trial of AAV - CNGB3 retinal gene therapy for patients with achromatopsia~   "
43202|NCT03001297|"~     A Phase 1, single dose study with 4 cohorts of ascending doses and an optional Japanese~     cohort designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of MEDI5884 in~     healthy volunteers~   "
43230|NCT03000933|"~     Australia was one of the countries to implement a universal school-based male vaccination~     program - in 2013. This research project will examine the prevalence of HPV among young men~     who have sex with men (MSM) who have been offered school-based HPV vaccination.~   "
44497|NCT02984371|"~     The aim of this prospective randomized study was to assess the efficacy of ablation of the~     ganglionated plexi localized in the epicardial fat pads for preventing recurrences of atrial~     tachyarrhythmia in patients with paroxysmal atrial fibrillation undergoing coronary artery~     bypass grafting.~   "
43203|NCT03001284|"~     Multiple sclerosis (MS), debilitating disease involving primarily the central nervous system,~     may cause cardiovascular dysfunction, due to autonomous nervous system dysfunction, physical~     invalidity, increased oxidative stress, and systemic inflammatory status, but the detailed~     mechanisms are not elucidated. The investigators aimed to assess left and right ventricular~     (LV and RV) function, left atrial (LA) function, arterial function, and~     atrial-ventricular-arterial coupling in patients with MS, compared to control subjects. LV~     systolic and diastolic function and RV function were assessed by 2D- and 3D-~     echocardiography, tissue Doppler, and speckle tracking echocardiography. LA function was~     assessed by LA volume index and LA strain. Arterial remodeling and stiffness were assessed by~     intima media-thickness, pulse wave velocity, and parameters of wave intensity and endothelial~     function~   "
43204|NCT03001271|"~     In the modern concept of Renin-angiotensin System, Angiotensin-(1-7) plays a key role and~     demonstrates promising therapeutic potential due to it is generally opposite effects to~     Angiotensin II. The aim is to evaluate the effect of Ang-(1-7) acute administration on~     systolic and diastolic blood pressure (SBP and DBP) and heart rate (HR) in healthy and~     hypertensive subjects.~   "
43205|NCT03001258|"~     Demand in near vision correction in the community exist in the Bangladesh with a thin~     presence of eye- care. This study aimed to test the skill of BRAC service-providers in~     identifying presbyopia-cases, to ensure frequent services, meeting the community need. This~     was non-inferiority equivalence randomized intervention trial, done during February-June~     2015, in six randomly selected sub-districts, where 2059 camp-patients were screened. BRAC~     Health-cadres; program organizers (PO), upgraded shasthya- shebikas (USS) and shasthya-~     shebikas (SS), were assigned to three different arms consisting two sub-districts through~     permuted-block randomization.105 eye-camps were organized with minimum 500 sample per arm.~     Sensitivity and specificity was calculated to understand screening performance. Screening~     reports were matched with the gold standard by recruiting refractionists.~   "
43206|NCT03001245|"~     The aim of this cluster randomized trial is to investigate whether the brief, 1+6 session~     psychosocial intervention, Interpersonal Counseling (IPC) is more effective than standard~     professional treatment (ST) in the treatment of mild or moderate depression among 12 to~     17-year-old adolescents in services provided by school health care and counseling~     professionals (school nurses, school psychologists and school social workers). The clients~     are identified from the pool of adolescents routinely seen in school health care and~     counseling services.~      A total of 54 school nurses, social workers, and psychologists from all public secondary~     schools in the standard education system of City of Espoo, Finland will be trained in IPC in~     a three-day workshop in two waves. Each school (plus the one primary care level health care~     unit for adolescents in Espoo) is represented by 1-3 trial IPC counselors. In the first wave~     the schools are cluster randomized to provide either A) 1+6 sessions of IPC, or B) 1+6~     sessions of standard treatment (ST), which consists of psychosocial work as guided by the~     workers' own standard professional principles and methods. The workers randomized to deliver~     IPC get the IPC training immediately. In the second wave those who delivered ST in the first~     wave will be trained in IPC. The data for this trial will be collected from the first wave.~     The data collection period is one school year plus follow-up of clients after 3 and 6 months.~      The clients are adolescents who have either self-referred themselves, are referred by other~     school personnel, or by parents to the services offered in the school due to emotional~     symptoms in the school year 2016 -2017 in the participating schools. They are screened with~     the BDI at the initial visit to identify depressive symptoms. A diagnostic interview will be~     administered to those exceeding a clinical cutoff. Main inclusion criterion is DSM-5~     depressive disorder of either mild or moderate severity. Those with current harmful alcohol~     use, acute suicidal ideation or behavior, severe depression or anxiety disorder, psychotic~     symptoms or very low global level of functioning are excluded and offered other treatment.~      The clients will complete self-report questionnaires (BDI) as outcome measures. Their level~     of depression symptoms will also be assessed with ADRS scale and their level of global~     psychosocial functioning with the CGAS by the project IPC counselors / ST providers.~     Moreover, the clients will complete the Young Person's Clinical Outcomes for Routine~     Evaluation (YP-CORE) as a measure of global symptomatology after each session. A follow-up~     interview at 3 months and 6 months after treatment termination will be arranged. The~     K-SADS-PL will be used for diagnostic evaluation, the ADRS and the C-GAS to assess level of~     depressive symptoms and global functioning, and the adolescent completes both the BDI and~     YP-CORE as self-reports of symptomatology.~   "
43207|NCT03001232|"~     The purpose of this study is to determine whether movement-oriented dementia care has a~     positive effect on quality of life and independence in activities of daily living (ADL) in~     nursing-home residents with dementia.~      It was hypothesized that movement-oriented dementia care has a positive effect on quality of~     life and independence in ADL, as well as on mood, behavior, cognition and physical~     functioning, in comparison to regular care.~   "
43208|NCT03001219|"~     This is a Phase IIa/b double-blind, placebo-controlled, randomized, parallel group,~     multicenter study to evaluate the safety and efficacy of RO7123520 as adjunctive therapy in~     participants with RA who are inadequately responding to standard-of-care (methotrexate and~     anti-TNF-alpha therapy). Part 1 of the study will evaluate safety. Part 2 will evaluate~     efficacy and safety. Part 3 will evaluate dose-ranging efficacy. Participants will have the~     option of continuing to the extension period of the study.~   "
43209|NCT03001206|"~     The purpose of this study is to evaluate the effectiveness and usability of the Master~     Caution System for 12 leads continuous monitoring of ECG signal in the ICCU.~      The purpose of the study is to evaluate the effectiveness and usability of using Master~     Caution 12 leads Garment for stress test.~      The purpose of the study is to reassess the adequate size of the Master Caution Garment.~   "
43210|NCT03001193|"~     The study will be designed as a double-blind, placebo-controlled, parallel-group,~     dose-finding study with one group treated with placebo and three groups treated with~     tafoxiparin in three different infusion concentration levels, respectively. The intravenous~     infusion will be initiated by a pre-defined bolus dose infusion.~   "
43211|NCT03001180|"~     The study will use participants tissue previously collected and stored in a tissue bank~     maintained by the Department of Hematology/Oncology as well as tissue banked in the future~     from participants undergoing prescribed surgical resection of vascular anomalies of interest~     proposed in this study. The principle investigator and study staff will also obtain blood~     from these participants.~   "
43212|NCT03001167|"~     This cross-disciplinary study will assemble and longitudinally follow a large, diverse birth~     cohort to determine the relationships between early life antibiotic exposure, microbiome~     development, and growth.~   "
43213|NCT03001154|"~     Virtual Reality Exposure Therapy (VRET) is an efficacious treatment of fear and anxiety, but~     because of the high financial costs and technical complexity of the past generation of VR~     hardware, there has been no large-scale implementation of this promising treatment. The~     present study will investigate whether off-the-shelf, commercial VR hardware and software can~     be used as stimuli material to conduct in-session exposure therapy for speech anxiety. The~     study will recruit n=25+25 participants from the general public suffering from substantial~     speech anxiety, who will be randomized to either a waiting-list, or one-session VRET with a~     therapist, followed by four weeks of a progressive maintenance program encouraging in-vivo~     exposure. The waiting-list group will then receive an Internet-delivered VRET treatment~     program.~   "
43218|NCT03001089|"~     Water and electrolytic homeostasis is remarkably controlled by the mineralocorticoid pathway~     (renin-angiotensin-aldosterone system acting on the renal tubule). However, the neonatal~     period in humans is characterized by a reduced ability of the kidney to ensure normal~     functions of urine concentration and maintenance of sodium and water balance. This renal~     functional immaturity, is associated in the very premature infants (VPT) (born <32 weeks of~     amenorrhea (SA)) to an immaturity of the adrenal responsible for a default of aldosterone~     biosynthesis . This relative aldosterone deficiency induces difficulties for VPT to adapt to~     extra-uterine life when maintaining a positive sodium balance is essential for postnatal~     growth. The improvement of perinatal care (antenatal corticosteroids maturation, ventilation~     techniques and use of surfactant) have increased the survival of these children .~     Nevertheless, extreme prematurity (less than 32 weeks), which concerns nearly 2% of live~     births in France, remains associated with neurodevelopmental sequelae in nearly 40% of~     children at 5 years .~      Secondary hydroelectrolytic disorders with transient mineralocorticoid adrenal insufficiency~     is probably one of the factors responsible of these neurological deleterious outcomes as well~     as the occurrence of other complications (bronchopulmonary dysplasia, enterocolitis~     necrotizing) of extreme prematurity. Indeed, aside from the administration of antenatal~     steroids to induce maturation, the prevention of postnatal dehydration reduces the risk of~     intracranial hemorrhage in that population. However, high fluid intake are associated with an~     increased incidence of patent ductus arteriosus, of bronchopulmonary dysplasia and~     necrotizing enterocolitis. This necessitates the evaluation of preventive measures to avoid~     such fluid and electrolyte imbalances by a pharmacological approach based on~     mineralocorticoid administration in very premature infants, due to the relative aldosterone~     deficiency identified in this population.~   "
43219|NCT03001076|"~     The purpose of this study is to determine if bempedoic acid (ETC-1002) added-on to ezetimibe~     therapy is effective and safe versus placebo in patients with elevated LDL cholesterol.~   "
43220|NCT03001063|"~     This stepped wedge, randomized controlled trial will test the effectiveness of a Supported~     Self-Management intervention for depression among adults in Vietnam. The intervention will be~     delivered at the community level in 8 Vietnamese provinces by primary care providers and~     social workers. The intervention group will receive the Supported Self-Management~     intervention, while the control group will receive enhanced treatment as usual. The primary~     outcome measure for depression is the Self-Reporting Questionnaire-20 (SRQ-20). The World~     Health Organization's Disability Assessment Scale (WHODAS 2.00 and the CAGE~     (Concern/Cut-down, Anger, Guilt, and Eye-opener) measures are also used to assess functional~     ability and alcohol misuse.~   "
43221|NCT03001050|"~     The overall goal of doing this study is to improve long term patient function and outcomes in~     the healing rates of Rotator Cuffs. The investigators would also like to see if this method~     can be more cost effective and time efficient for Rotator Cuff evaluation during arthroscopy.~   "
43222|NCT03001037|"~     This study will compare patients with low back pain (LBP) to age and gender matched controls~     to determine if there are differences between the two groups related to: range of movement,~     secondary outcomes (level of disability, quality of life, evidence of depression, anxiety or~     stress), movement patterns and demographic characteristics. The first phase will include a~     baseline and 3 month follow-up assessment of the LBP patients and controls, including~     demographic characteristics, outcome measures, and a physical assessment. The second phase is~     an ongoing phase with continued interim assessments of LBP patients only, at 6 and 12 months.~   "
43223|NCT03001024|"~     Responsible Beverage Service Training (RBS) has been shown to be effective and recent~     research by this research team has shown that online RBS training (WayToServe®) was more~     effective, particularly over time, than usual and customary (UC) RBS training by live~     trainers. However, one growing segment of alcohol servers and sellers has been neglected in~     RBS training efforts: Hispanic primarily Spanish-speaking servers in predominantly~     Spanish-speaking premises. This project will develop and test the first online RBS training~     for predominantly Spanish-speaking servers, WayToServe Español, which is culturally and~     linguistically appropriate and will fill a gap in evidence-based alcohol prevention~     interventions for this underserved population.~   "
43224|NCT03001011|"~     Primary Objective:~      To demonstrate efficacy of Renvela tablets in the reduction of serum phosphorus in~     hyperphosphatemia in patients with chronic kidney disease not on dialysis.~      Secondary Objectives:~      To document the efficacy of Renvela tablets in the reduction of serum lipids (total~     cholesterol and low-density lipoprotein cholesterol [LDL-C]) To document the efficacy of~     Renvela tablets in the reduction of calcium-phosphorus product.~      To document the efficacy of Renvela tablets in the reduction of intact parathyroid hormone~     (iPTH).~      To document the efficacy of Renvela tablets in proportion of patients reaching the target~     serum phosphorus level (4.6 mg/dL [1.47 mmol/L], inclusive).~      To evaluate safety of Renvela tablets.~   "
43225|NCT03000998|"~     The uptake of vaccines for Human Papillomavirus (HPV) in the U.S. is far below recommended~     levels, particularly for adolescent boys and especially among minority families. Proposed~     here is a mobile web application (mobile web app) for personal computers, smart phones, and~     tablet computers that will accurately inform parents and adolescent boys about the HPV~     vaccination and address unique concerns about its safety and effectiveness for boys. The~     BoyVac mobile web app will be evaluated for its ability to improve vaccine outcomes in a~     randomized efficacy trial with parents and adolescent boys aged 11-13 years who obtain care~     in pediatric clinics in the University of New Mexico Health Sciences Center's Envision~     network.~   "
43226|NCT03000985|"~     The involvement of family members is crucial and improves the prognosis of psychiatric~     patients and reinforces therapeutic adherence and reduces the frequency of relapses. For~     schizophrenia, the scientific literature clearly shows that it's in the interest of the~     patient to offer to his family a psychoeducational program.~      Therapeutic education programs are now part of the recommendations of good clinical practice~     and in the French health through the law n ° 2009-879 of July 21, 2009 on the reform of the~     hospital and relating to patients, health and territories.~   "
43227|NCT03000972|"~     This study evaluates the potential negative effect of cement augmentation in the femoral head~     on viability of the head. Half of the participants will have the standard intramedullary nail~     (PFN-A; Proximal Femoral Nail Augmentation), while the other half will get the standard nail~     plus cement augmentation.~   "
43228|NCT03000959|"~     This study aims to assess the effectiveness of Stroke Unit in the Philippines by comparing~     the functional outcome between those patient admitted in the general neurology wards and~     stroke units using modified Rankin Scale~   "
43229|NCT03000946|"~     The purpose of this study is to determine whether somatostatin is more effective that~     octreotide in the prevention of post-pancreatectomy pancreatic fistula~   "
44498|NCT02984358|"~     Compare chronic (one week) of a 'normal' meat diet with one week of mycoprotein consumption,~     with or without a reduced nucleotide content, on markers of metabolic health, such as uric~     acid concentrations, blood glucose control and blood lipid profiles.~   "
43231|NCT03000920|"~     Each year in France, breast cancer affects about 48,000 women and is the first cause of~     cancer death in women with 11,900 deaths estimated.~      Since 2004, there is a national organized breast cancer screening (OBCS) programme for~     asymptomatic women aged 50-74 and with a medium-risk. Every two years, the local cancer~     screening department sends a personalized invitation mail to eligible women to perform a~     mammogram and a breast clinical examination. One to two reminder mails are sent to women who~     have not done the screening after an initial invitation. Despite this programme, almost 47%~     of women in France do not participate to organized breast cancer screening.~      The Short Message Service (SMS) is an innovative communication tool in the field of health,~     immediate, reliable delivery, low cost and ecological. The use of SMS could be an innovative,~     low-cost, personalized and ecological way to support the OBCS invitation strategy.~      The overall objective of this study is to preserve or even better increase participation in~     organized breast cancer screening while decreasing the associated costs by including SMS in~     our screening invitation procedure.~      Two SMS interventions will be tested which will correspond to different phases of the OBCS~     invitation procedure. This sequence of interventions leads us to perform three interlinked~     trials: a trial of superiority for the first phase (intervention 1: sending an SMS a few days~     before the initial mail invitation), then two non-inferiority trials for the second phase (~     two trials=one for each context of phase 1 _ intervention 2: sending an SMS in place of the~     first postal reminder).~   "
43232|NCT03000907|"~     Rationale: There is increasing evidence that obesity may be a risk factor for frailty in the~     elderly. Obesity favors a state of chronic inflammation and insulin resistance, involves a~     fatty infiltration of the muscle and an increased cardiovascular risk and, in addition, obese~     people usually perform less physical activity. All this favors the loss of mass and muscular~     function (sarcopenia), a key component of the fragility and the functional deterioration.~      Objectives: To evaluate the effectiveness of a multimodal intervention to lose weight in the~     prevention of frailty in obese elderly people, as well as to know the main mechanisms~     involved in the frailty process.~      Methodology: Design: Controlled, randomized, open-label clinical trial with two parallel~     intervention arms and 2 years follow-up. Study population: People between 65 and 75 years of~     age, obese (BMI ≥30), without criteria of fragility and living in the community. Study~     intervention: multimodal and personalized intervention with the support of a personal~     trainer that has two main axes of action: a) diet: assessment of nutritional status and~     nutritional requirements and establishment of personalized nutritional plan with monthly~     dietetic controls and b) physical exercise: a multi-component physical exercise program that~     will include aerobic exercise and strengthening, balance and flexibility exercises as well as~     a weekly group session of health education, during six months. Main outcome measures (to be~     evaluated annually for 2 years): Fragility (according to the L Fried criteria) and Sarcopenia~     (according to the criteria of the European Working Group on Sarcopenia in Older People~     -EWGSOP). Sarcopenia is considered if there is a decrease in gait velocity or muscle grip~     strength (measured with a dynamometer) and a decrease in muscle mass assessed by bioimpedance~     (BIA). Intermediate outcome measures (at 6, 12 and 24 months): a) weight loss, b) changes in~     body composition and distribution of body fat, c) glycemic control (HbA1) and insulin~     resistance (by HOMA index (HOmeostasis Model Assessment)), d) cardiovascular risk according~     to the REGICOR algorithm, e) functional capacity (according to Barthel Index and 2 Minute~     Walking Test), f) inflammatory markers (IL-6, CRP(C reactive protein), TNF(Tumor Necrosis~     Factor)-alpha and leptin) and g) anabolic hormones (IGF-1, ghrelin and testosterone).~   "
43233|NCT03000894|"~     This study aims to investigate the effectiveness of transdiagnostic nurse-administered~     4-session group cognitive behavioral therapy for insomnia (CBT-I) plus standard care,~     compared to standard care alone, for improving sleep and daytime function, enhancing~     recovery, preventing relapses, and reducing medication burden in patients with the first~     episode of mood disorders.~   "
43234|NCT03000881|"~     The study investigates the impact real output has on peristomal skin covered by two different~     adhesives~   "
43235|NCT03000868|"~     This study evaluates the efficacy of small colorectal polyp removal using cold endoscopic~     mucosal resection with hot endoscopic mucosal resection. Half of the participants will~     receive cold endoscopic mucosal resection, while the other half will receive hot endoscopic~     mucosal resection.~   "
43236|NCT03000855|"~     EUS - guided choledocho-duodenostomy (ECDS) is an established option for bile duct drainage~     in unresectable malignant distal CBD strictures when endoscopic retrograde~     cholangiopancreatography (ERCP) fails. However, how primary ECDS compares with ERCP with~     covered self-expanding metallic stents (CSEMS) in unresectable malignant distal CBD~     strictures is uncertain.~      The aim of the current study is to compare primary ECDS versus ERCP with CSEMS in~     unresectable malignant distal CBD strictures. We hypothesis that ECDS is associated with a~     higher 1-year stent patency rate.~   "
43237|NCT03000842|"~     The vagal stimulation is a promising therapy for a lot of disorders as well as hemodynamic~     regulatory way. In order to minimize the harm of a surgery chip implantation, actually it was~     developing a non-invasive device that is able to stimulate the auricular branch of vagal~     nerve. It has been shown that trans-auricular vagal stimulation (tVNS) causes direct~     stimulation of the vagal nerve. However, there are still no strong evidences about it actions~     regarding the autonomic modulation. The aim of this study is to evaluate effects of tVNS on~     heart rate, blood pressure and the autonomic control in healthy and hypertensive subjects, at~     rest and after orthostatic position~   "
43238|NCT03000829|"~     This multicenter randomized trial will employ in-situ cardiac arrest simulations (mock~     codes) to test whether using telemedicine technology to add an intensive care physician as~     the copilot for cardiac arrest resuscitation teams influences chest compression quality,~     resuscitation protocol adherence, team function, and provider experience.~   "
43239|NCT03000816|"~     The aim of this phase II trial is to assess the DCR, local control, non-progress survival,~     overall survival, safety and tolerability of SBRT to treat patients with oligometastases in~     esophageal squamous cell carcinoma.~   "
43240|NCT03000803|"~     The purpose of this study is to examine how the timing of eating changes how the body makes~     and uses energy (metabolism). This study will also examine how fat cells respond to insulin~     (a hormone that controls blood sugar levels).~   "
43241|NCT03000790|"~     To evaluate the effectiveness of Lingual Ring Splint For Management of Anterior Disc~     Displacement With Reduction~   "
43242|NCT03000777|"~     The purpose of this study is to evaluate the effects of oral melatonin plus zinc~     supplementation in relieving self-reported fatigue in CFS/ME~   "
43268|NCT03000439|"~     A randomized withdrawal study in which responders to open-label treatment with tofacitinib~     will be randomized in a 1:1 ratio to tofacitinib or placebo in a double-blind phase. In the~     double-blind phase time to sJIA flare will be evaluated as primary endpoint and subjects~     will be discontinued once they experience sJIA flare. Once 31 flares are reported the study~     will be completed.~   "
46702|NCT02955576|"~     The purpose of this study is to evaluate the efficacy of microneedle patch on the psoriatic~     plaques.~   "
43243|NCT03000764|"~     The purpose of this study is to seeking a molecular signature of pathological radiation~     induced fibrosis based on the response of skin fibroblasts after irradiation, comparing two~     groups of patients distinguished by their individual radiosensitivity. The signature will~     integrate recent insights in terms of alternative splicing of mRNAs and level of expression~     of non-coding RNAs, particularly long non-coding RNAs, snRNAs, snoRNAs and microRNAs. In each~     group each expression patterns of candidate HSP proteins potentially predictive of~     pathological radiation induced fibrosis (HSP27, HSP70, αβ crystalline) in the serum and on~     cell culture will be characterized.~   "
43244|NCT03000751|"~     This is a pragmatic stepped-wedge cluster randomized controlled trial to explore variation in~     doses used for diagnostic CT by pooling radiation dose data across diverse healthcare~     delivery systems.~      To compare different strategies for lowering and optimizing dose and identify the barriers~     and facilitators to implementing successful dose optimization strategies and standardizing~     practice.~   "
43245|NCT03000738|"~     The purpose of this study is to determine whether the CD16- monocyte/CD16+ monocyte ratio~     could help predict the prognosis of DLBCL and PTCL.~   "
43246|NCT03000725|"~     The purpose of this study is to adapt Project UPLIFT for Hispanic adults with epilepsy and~     depression. Project UPLIFT (Using Practice and Learning to Increase Favorable Thoughts) is a~     home-based intervention that teaches cognitive and mindfulness skills to people with epilepsy~     by phone to reduce their depression and improve quality of life (QOL); it was developed at~     Emory University with CDC funding. The purpose of this study is to adapt Project UPLIFT for~     Hispanic adults with epilepsy and depression. Project UPLIFT (Using Practice and Learning to~     Increase Favorable Thoughts) is a home-based intervention that teaches cognitive and~     mindfulness skills to people with epilepsy by phone to reduce their depression and improve~     quality of life (QOL); it was developed at Emory University with CDC funding.~   "
43247|NCT03000712|"~     The purpose of this study is to evaluate the efficacy and safety of intra-articular injection~     of autologous adipose tissue derived mesenchymal stem cells compared after high tibial~     osteotomy to negative control in the osteoarthritis patients~   "
43248|NCT03000699|"~     The purpose of this study is to determine whether computer bias modification for~     interpretation bias (CBM-I) is effective in the reduction of suicidal ideation in substance~     use disorders.~   "
43249|NCT03000686|"~     This study is conducted to examine how GSK2586881, a recombinant human ACE2 peptide,~     modulates the acute hypoxic pulmonary vasoconstriction (HPV) response in healthy volunteers.~     The study will be single-center, randomized, placebo-controlled and double blind (sponsor~     open). Subjects will be randomized to receive a single intravenous (IV) dose of GSK2586881 or~     placebo (saline) in a crossover design. The primary objective of the study is to evaluate the~     effect of a single IV dose of GSK2586881 on the HPV response in healthy volunteers during~     exercise under hypoxic conditions. Approximately 35 subjects will be enrolled for a maximum~     of 56 days.~   "
43250|NCT03000673|"~     To investigate safety of Single Doses of BMS-986177 in Patients with End Stage Renal Disease~     treated with hemodialysis~   "
43251|NCT03000660|"~     This is a study to determine the safety, tolerability and maximum tolerated dose of~     Venetoclax (ABT-199) and dexamethasone in relapsed or refractory amyloid light chain (AL)~     amyloidosis patients.~   "
43252|NCT03000647|"~     The aim of the study is to evaluate the effectiveness of guided versus non guided pelvic~     floor exercises for urinary incontinence in patients with Relapsing-Remitting Multiple~     Sclerosis~   "
43253|NCT03000634|"~     This study will compare the effectiveness and safety of maintenance therapy with continuous~     bortezomib, lenalidomide, and dexamethasone (VRD) compared to maintenance therapy that~     alternates VRD with Elotuzumab, lenalidomide, and dexamethasone (Elo RD) every eight weeks.~   "
43254|NCT03000621|"~     The objectives are to:~        1. validate a panel of tissue-specific miRNAs that are differentially expressed in the~          plasma of patients with and without liver injuries~        2. investigate the physiological range of the circulating miRNA panel in Healthy Subjects~          and under stress~        3. investigate the dysregulation of circulating miRNA panel and their prognostic and~          predictive values in clinical outcomes in identifying patients at high risk for~          mortality and acute liver failure.~      This trial involves peripheral blood sampling from subjects at their earliest presentation~     and remaining stays in the hospitalization in the emergency department. The investigators~     will develop panels of miRNAs that are specific indicator of early onset of major organ~     failures, and correlate clinical outcomes with these miRNAs.~   "
43255|NCT03000608|"~     This trial will be a double-blind, multi-center, randomized, placebo controlled study to~     evaluate the safety, tolerability, and efficacy of SAN021 study drug when administered for up~     to 42 days to adults between the ages of 18 to 65 years who have a clinical diagnosis of~     mild-to-moderate plaque psoriasis.~   "
43256|NCT03000595|"~     This trial will be a double-blind, randomized, placebo-controlled, safety, tolerability and~     efficacy trial of SAN007 (5% East Indian sandalwood oil in a cream formulation) treatment~     regimen when administered daily for up to 28 days to patients from 3 months to 65 years of~     age, with atopic dermatitis.~   "
43257|NCT03000582|"~     The purpose of this study is to examine the pharmacokinetics of creatine nitrate~     supplementation.~   "
43258|NCT03000569|"~     This study will assess the safety, tolerability, pharmacokinetics and efficacy of SAGE-217 in~     up to 30 subjects with Parkinson's Disease of Moderate Severity.~   "
43269|NCT03000426|"~     The aim of this study is to compare the influence of two different energy densities for~     photobiomodulation on recovery of palatal donor area after free gingival graft technique.~   "
43270|NCT03000413|"~     Despite few scientific evidence that could support the use of ketamine in adult patients~     undergoing acute bronchospasm requiring mechanical ventilation (MV), ketamine is largely~     employed in this setting. The aim of this study is therefore assess more definitively the~     real benefit of using ketamine in patients with severe bronchospasm, requiring ICU stay and~     need for MV in order to establish or refute the use of this drug as standard therapy in~     these cases.~   "
43397|NCT02998762|"~     The LTFU study will conduct a naturalistic follow up of the well characterized CAN-BIND study~     population of patients every six months and continuing over a five-year period. This will~     provide information on the longitudinal progress in mood, functioning, and quality of life of~     the CAN-BIND sample with a view towards long-term outcome and treatment.~   "
43259|NCT03000556|"~     Corneal abrasion (TCA) is the most common ophthalmic emergency disease, accounting for about~     10% of the American ophthalmic emergency, accounting for 22% of the ophthalmic emergency in~     Zhongshan Ophthalmic Center. Clinical emergency treatment of TCA is relatively simple and~     effective, corneal epithelial damage can be recovered within 48 hours. However, about 25% TCA~     would be developed to the recurrence of exfoliation. Once the recurrence of TCA, the~     treatment would be more difficult and even cause blindness. Therefore, it is of great~     practical significance to prevent the recurrence of TCA. However, there is no effective~     methods to prevent recurrence of TCA.~      0.3% sodium hyaluronate eye drops can effectively supplement the shortage of tear and promote~     repair of corneal epithelium. On this basis, the investigators hypotheses that 0.3% sodium~     hyaluronate eye drops can prevent the recurrence of TCA. So, investigators intend to test~     effectiveness of 0.3% sodium hyaluronate drops to prevent the recurrence of TCA by a~     prospective, single center, randomized, controlled pilot study. In this study, 60 patients~     with TCA were randomly divided into control group and sodium hyaluronate treatment group and~     observed one year.~   "
43260|NCT03000543|"~     Background:~      Serum vitamin A (VA) concentration is not an authenticate indicator of VA status, while~     existing deuterium- VA isotope dilution methods to determine whole body VA status require 3~     weeks and not applicable for infants and children. Our research group has recently developed~     a new simplified equation to measure VA pool size in 4-5 days, highly correlated with~     compartmental model-predicted value and estimate VA pool size in adults with high precision.~     However, it is not clear whether this new simplified equation also works in infants and~     children. In this proposed study, we validate the method in healthy infants with or without~     inflammatory condition.~      Hypothesis:~      Whole-body VA status in infant can be estimated without accounting for fractional catabolic~     rate in the context of inflammatory condition in infants~      Methods:~      At firstly we need to undertake one feasibility study to verify whether the oral dose of 400~     μg 13C10 or 13C3- retinyl acetate (isotopic VA) that we propose to use in this study would~     work in infants as we observed in adults, secondly, whether PENTA valent vaccines induce~     inflammation in infants (plasma CRP as maker) that closely mimics natural infection. To~     minimize the taking of multiple blood samples from each infant, a super kid study design~     will be adopted that ensure no more than 2 venous blood samples from each infant, even though~     multiple time points (at least 5 subjects / time-point) over a 28-day study period will be~     available for mathematical modelling. A total of 115 infants (9-11 mo) will receive an oral~     dose of 13C10- retinyl acetate (400 μg) dissolved in 0.5 mL of sunflower oil and then blood~     samples will be taken from 6h to 16th day at 9 different time-points. On day 16, a single~     dose PENTA vaccine will be provided to the randomly selected 50% of infants. On day 17,~     another type of stable isotopic VA e.g. 13C3- retinyl acetate (400 μg) will be orally~     supplemented to all infants. Blood sample will be collected from day 16 to day 28 at 11~     different time-points for each of the vaccine and non-vaccine groups. Specific activity of~     13C10-VA and 13C3-VA from the blood samples will be measured by liquid chromatography-tandem~     mass spectrometry (LC/MS/MS).~      Outcome measures/variables:~      The early time point equation for assessing VA pool size in a group of infants with or~     without inflammation~   "
43261|NCT03000530|"~     This is a two-part (open-label followed by double-blind) study evaluating the safety,~     tolerability, pharmacokinetics, and efficacy of SAGE-217 in approximately 98 subjects~     diagnosed with moderate to severe Major Depressive Disorder.~   "
43262|NCT03000517|"~     The emergence and spread of multi-drug resistant and extensively-drug resistant strains of~     Mycobacterium tuberculosis (MDR/XDR-TB) have posed a great threat to global TB control and~     elimination, limiting treatment success rate at worrisome 50% for MDR-TB. Among various~     factors contributing to the development of drug resistance, low drug exposure is well~     recognized. To overcome this, either new drugs have to be developed or the dose of currently~     used therapy be optimized, or both. Fluoroquinolones (levofloxacin and moxifloxacin) and~     aminoglycosides are important drugs in the MDR-TB treatment regimen. Development of acquired~     drug resistance to these drugs could complicate and narrow down the available options, and~     further exacerbate to pre-XDR and XDR-TB.~      Objective:~      The main objective of this prospective clinical study is to understand the pharmacokinetics~     of levofloxacin in MDR-TB patients, receiving standard dosage (750-1250mg) based on the body~     weight and correlate drug exposure, with treatment outcomes.~      Study design:~      A prospective pharmacokinetic study~      Study population: 20 MDR-TB patients~      Intervention: Patients receive once daily oral dosing of levofloxacin (750-1250mg) based on~     the body weight, under MDR-TB treatment regimen of Nepal.~      Main study parameters/end points:~      The pharmacokinetic parameters(Vd, CL, AUC etc.) of levofloxacin are the primary end points~     of the study. The Cmax/MIC and AUC0-24h/MIC ratios are the best predictive parameters for~     efficacy of levofloxacin treatment and will be estimated. Pharmacokinetics will be evaluated~     in plasma and in oral fluid~   "
43263|NCT03000504|"~     This study is designed to assess whether a new type of chest drain reduces the number of~     drains that fall out of or are accidentally removed from the chest cavity (usually requiring~     another drain to be inserted), without causing any increase in discomfort or other~     side-effects.~   "
43264|NCT03000491|"~     This study forms an initial phase of work aimed at developing a learning health system (LHS),~     whereby data relating to asthma is extracted from patient electronic health records (EHRs)~     across Scotland, analysed to explore variations in clinical practice and then shared with~     general practices to highlight any improvements that can be made so that they can better~     support people with asthma.~      If successful, the investigators hope to progress to the main quality improvement phase~     involving an increased number of practices and then incrementally build this up to cover the~     whole of Scotland.~   "
43265|NCT03000478|"~     This non inferiority trial will compare Prolonged Exposure with Virtual Reality Exposure~     Therapy in adult patients with combat related PTSD.~   "
43266|NCT03000465|"~     Optimizing all factors that increase the intra-abdominal volume and performing an~     individualized strategy should allow us to reduce the pneumoperitoneum insufflation pressure~     while maintaining optimal surgery conditions for a laparoscopic colorectal surgery, compared~     to the standard strategy of maintaining fixed intra-abdominal insufflation pressures (12-15~     mmHg).~   "
43267|NCT03000452|"~     This is a single-arm, multicenter, Phase 2 study to evaluate the efficacy and safety of the~     combination regimen of daratumumab plus durvalumab (D2). The study will consist of 2 parts;~     Part 1 has a 2-stage design while Part 2 consists of an expansion phase. Subjects will~     receive intravenous (IV) DARA at 16 mg/kg on the same dosing schedule (weekly [QW], every 2~     weeks [Q2W] or every 4 weeks [Q4W] of each 28-day cycle) received on their last prior therapy~     containing DARA. The dosing schedule for DARA may be adjusted during the course of the study~     as outlined in the protocol. Subjects will also receive IV DURVA at 1500 mg on Day 2 (Cycle~     1) and on Day 1 (Cycles ≥ 2) of each 28-day treatment cycle.~   "
43326|NCT02999685|"~     Regular physical activity has been found to be important in maintaining health and well-being~     in people with COPD. The purpose of this study is to test new technology and health coaching~     aimed to help people with COPD become more physically active in their daily lives.~   "
43271|NCT03000400|"~     The purpose of this study is to determine the effectiveness of a multi-professional~     theoretically based family centered intervention, The Traumatic Brain Injury Family System~     Intervention (TBIFSI), for the family members and TBI patients in improving family dynamics~     and functioning. The intervention will be provided in collaboration with the municipal~     rehabilitation service. The intervention group will be compared with a control group~     receiving treatment as usual, defined as an individually tailored multidisciplinary approach,~     and the family members will attend one ongoing psycho-educational group session of 2.5 hour~     provided by Oslo University Hospital (OUH).~   "
43272|NCT03000387|"~     Medications for smoking cessation are currently only effective in helping a minority of~     smokers quit. Drug development is slow and expensive, so there is much interest in optimizing~     the effectiveness of existing treatments and medications. Current standard doses of nicotine~     replacement therapy (NRT) are not effective for many smokers and in many cases provide less~     nicotine compared to when a smoker is smoking their usual number of cigarettes. The proposed~     study will test if a personalized dose of nicotine patch (up to 84mg) will improve quitting~     success in those who do not respond to a standard dose of NRT (21mg).~   "
43273|NCT03000374|"~     Patients with rectal adenocarcinoma of intermediate risk (defined by magnetic resonance~     imaging [MRI]), without mutations in KRAS, BRAF, NRAS and PI3KCA, who are candidates for~     preoperative treatment, will receive a preoperative Induction therapy with 12 weeks of~     panitumumab with mFOLFOX-6 to evaluate the efficacy in terms of pathologic complete response~     (pCR)~   "
43274|NCT03000361|"~     The aim of this study is to assess the feasibility and the safety of the Novel Motorized~     Spiral Endoscope to examine the colon. The study is conceived as proof of concept trial with~     the primary aim to achieve a cecal intubation rate of at least 90 % according to quality~     guidelines recommendations. All other clinically relevant quality parameters of standard~     colonoscopy will be evaluated as secondary aims comparable to our recent trial. This study~     represents the first clinical evaluation of using a motorized spiral assisted endoscope for~     examination of the colon with potential advantages for patients in terms of effectiveness and~     convenience of colonoscopy.~   "
43275|NCT03000348|"~     This study investigates the use of cysteamine in the treatment of adults with Cystic Fibrosis~     who are experiencing an exacerbation of CF-associated lung disease. There are six different~     potential dosing regimens, including one that is placebo.~   "
43276|NCT03000335|"~     Previous findings have shown that a biomarker comprised of the three microRNAs (miRs)~     miR-451, miR-151-5p and miR-1290 can independently predict precursor B-cell acute~     lymphoblastic leukemia (B- ALL) patients' risk for relapse when measured in cells from a bone~     marrow (BM) aspiration taken at diagnosis (Avigad et al., 2016: Genes, Chromosomes & Cancer~     55:328-339). Curewize Health recognizes that the development of a minimally invasive blood~     test for frequent long-term monitoring can greatly benefit pediatric precursor B-ALL~     patients. Therefore, the current study will investigate the monitoring ability of miR-451,~     miR-151-5p and miR-1290 measured in blood samples. The study will be performed in two stages:~      Stage 1-Cross-Sectional Study: Blood samples will be collected from relapsed pediatric B-ALL~     patients and B-ALL patients in remission. Blood will be collected from each patient in three~     tubes, for serum, plasma and whole blood analysis, in order to interpret the best blood~     source for measuring miR-451, miR-151-5p and miR-1290. The level of the miRs in blood will be~     compared between relapsed B-ALL patients to B-ALL patients in remission. If the Stage 1~     Cross-Sectional study is successful, the investigators will continue the clinical trials to~     the Stage 2 Prospective Monitoring study.~      Stage 2-Prospective Monitoring Study: Blood will be collected from patients at diagnosis and~     at routine clinical follow-up. Patients can be up to five years from diagnosis. The source of~     blood found to be most optimal for measuring the miR levels is Stage 1 will be collected. The~     final design of the Stage 2 study will be decided after completion of the Stage 1 study.~   "
43277|NCT03000322|"~     This study is intended to determine the efficacy of the Cooling Vest in reducing the~     frequency and intensity of hot flashes and night sweats in men undergoing chemotherapy~     treatment for prostate cancer.~   "
43278|NCT03000309|"~     Sixteen week open label study of apremilast in combination with topical steroids with a four~     week safety follow up visit.~   "
43279|NCT03000296|"~     This study evaluates the safety and clinical benefits of a therapeutics approach of~     conditioning regimen Cyclophosphamide (Cy) + Thymoglobulin r (ATG) + Granulocyte~     Colony-Stimulating Factor (G-CSF) followed by autologous Hematopoietic Stem Cell~     Transplantaion (HSCT) rescue in therapy refractory Crohn's disease. It will be counted~     adverse events, clinical and endoscopic condition at various short and long-term time points.~   "
43280|NCT03000283|"~     The goal of this study is to preliminarily determine/estimate feasibility and whether~     frequent and early conivaptan use, at a dose currently determined to be safe (i.e.,~     40mg/day), is safe and well-tolerated in patients with cerebral edema from intracerebral~     hemorrhage (ICH) and pressure (ICP). A further goal is to preliminarily estimate whether~     conivaptan at this same dose can reduce cerebral edema (CE) in these same patients. This~     study is also an essential first step in understanding the role of conivaptan in CE~     management.~      Hypothesis: The frequent and early use of conivaptan at 40mg/day will be safe and~     well-tolerated, and also reduce cerebral edema, in patients with intracerebral hemorrhage and~     pressure.~   "
43281|NCT03000270|"~     Direct active unloading of the left ventricle with the Impella CP System prior to PPCI in~     patients with ST-elevation myocardial infarction (STEMI) is safe and feasible~   "
43282|NCT03000257|"~     This is an open-label, Phase I, dose-escalation study to determine the recommended Phase 2~     dose (RPTD), maximum tolerated dose (MTD), and evaluate the safety and pharmacokinetic (PK)~     profile of ABBV-181. This study will also evaluate the safety and tolerability of ABBV-181 in~     combination with Rovalpituzumab Tesirine. The study will consist of 2 parts: ABBV-181~     monotherapy dose escalation and expansion, and ABBV-181 in combination with Rovalpituzumab~     Tesirine.~   "
43344|NCT02999451|"~     POEM is a new intervention for the treatment of achalasia and has been reported to relieve~     the dysphagia symptom effectively. Although the cost of POEM method is less than the method~     of Laparoscopic Heller Myotomy and Fundoplication, it is still of an economic burden for the~     patients with achalasia. In this trial, investigators plan to use snare to assist POEM~     procedure, to observe the safety, efficacy and cost-effectiveness of this method, compared~     with other knifes-assisted procedure.~   "
43283|NCT03000244|"~     Background:~      People who have had an allogeneic hematopoietic stem cell transplant (HCT) have bone marrow~     or an immune system that is damaged. They get stem cells from a donor who is a relative.~     Researchers want to study stem cell donors and recipients to learn about the long-term~     effects of HCT. They want to learn how the stem cells change and how to improve their ability~     to fight cancer.~      Objective:~      To provide long-term follow-up care for people who underwent or will undergo HCT. To collect~     data, blood, and tissue samples to learn about late complications after HCT.~      Eligibility:~      Adults age 18 and older who will undergo HCT or underwent HCT and are surviving one year or~     more from the date of HCT. The stem cell donors for these recipients are also needed.~      Design:~      Recipients will have 1 visit each year. They will have a physical exam. They will answer~     questions about their medical history and health. They will receive screening and~     surveillance testing. They will complete brief questionnaires.~      Recipients will have blood tests. They may have tissue biopsies or specimens (such as tissue~     in their cheek or skin or bone marrow biopsy).~      Recipients will give their current address and phone number, and the same data for one or two~     other people, who can get in contact with them.~      After the first visit at the clinic, some recipients may see a doctor close to home to get~     the necessary information and send it to NIH.~      Donors will come to the clinic for 1 visit. They will answer questions about their medical~     history. Blood samples will be taken.~   "
43284|NCT03000231|"~     The purpose of this study is to compare cardio-metabolic risk, glucose tolerance, and night~     time blood pressure between healthy control subjects and patients with adrenal insufficiency.~     No intervention will be administered and the study is observational only.~   "
43285|NCT03000218|"~     A clinical study to evaluate pharmacokinetics, metabolomics and biomarker in subjects who are~     overweight and have liver problems after ursodeoxycholic acid multiple administration~   "
43286|NCT03000205|"~     Using hypertonic dextrose water for chronic supraspinatus tendonitis and using ultrasound as~     assessment tool to evaluate the effect of intervention.~   "
43287|NCT03000192|"~     The purpose of this study is to invite all people diagnosed with cancer who meet the~     eligibility criteria to complete questionnaires before their treatment begins and at regular~     intervals over time to assess the impact of cancer and its treatment on people's lives in the~     short, medium and long term. We will explore a range of factors to determine their role in~     both recovery of health and well-being and self-management. Although it is known that people~     who have had cancer are likely to experience a number of physical and psychological problems~     as a result of the disease and treatment, it is not known what the 'typical' course of~     recovery of health and well-being looks like, how long it takes and how this can be~     influenced. We will determine pathways to recovery of health and well-being following cancer~     diagnosis (initially breast cancer diagnosed <50 years, Non-Hodgkin Lymphoma and~     gynaecological cancers) and identify what factors influence this. This includes assessing the~     relative importance of the person's illness, personal attributes, perceived burden of~     treatment, role of the environment they live in, including health / social care and personal~     networks of support, and their ability and capacity to self-manage. We will identify who is~     most at risk of problems and what environmental supports and resources people are able to~     mobilise to support their self-management. We will also explore who has the confidence and~     ability to manage during and beyond treatment and what factors influence this and whether~     this leads to earlier problem resolution and restoration of health and well-being. This~     knowledge will be used to develop and test future supportive interventions to enhance the~     rapid recovery of health and well-being - our long term aim being to design ways of helping~     people with cancer in areas we identify as problematic for them.~   "
43288|NCT03000179|"~     This is a single-agent, open label, one-arm phase 2 pilot study of avelumab in patients with~     advanced or metastatic adenocarcinoma of the small intestine.~   "
43289|NCT03000166|"~     The purpose of the study is to determine the impact of a physical activity intervention on~     the self-management of fatigue in young adults receiving chemotherapy. Half of the~     participants will receive an intervention which includes education and resources to set~     physical activity goals and monitor progress toward goals.~   "
43290|NCT03000153|"~     Recent evidence suggests that focusing on positive goals rather than problems to avoid, may~     be associated with better psychological health and attainment of goals. In addition, the~     advantages of using personalised measures have been highlighted in a number of studies. The~     Goals Form is a new measure that comprises both elements. It invites clients, in~     collaboration with their therapist, to identify up to seven goals for therapy typically at a~     first assessment session and then to rate them on a 1-7 Likert scale, with 1 being not at all~     achieved and 7 being completely achieved. This research is important for clinical practice as~     it provides the foundations to identify what might be a helpful factor in counselling and~     psychotherapy.~      The aim of the study is to test whether the use of the Goals Form leads to better clinical~     outcomes in counselling and psychotherapy. Participants in this study are counsellors and~     service users at Tower Hamlets Mind. The design of this study is a trial, which looks at~     comparing outcome measure scores in 'therapy as usual' and 'therapy using the Goals Form'~     when participants are randomly assigned to one of the two conditions. Interventions in this~     study involve using the Goals Form at the start of every session and taking part in a 30~     minute interview once therapy has ended to give feedback about using the form in therapy . In~     addition to assessing outcome, the study also serves to compare satisfaction scores across~     the two conditions. It is a pilot to determine the feasibility of such trial including~     recruitment rates over a period of a year, adherence of counsellors and clients to the~     protocol, and the ethical issues raised.~   "
43291|NCT03000140|"~     Despite exercise training decrease blood pressure in 'average' terms, there is a wide~     interindividual variability after exercise training, being yet unknown what mode of exercise~     (e.g. endurance, strength, concurrent, or high intensity interval training) produce more/less~     non-responder (NR) prevalence (i.e., percentage of subjects who experienced a~     non-change/worsened response after training in some outcome).~   "
43292|NCT03000127|"~     Fatigue is a major symptom in people with multiple sclerosis (MS), for which treatments are~     limited. Several studies have shown that a large proportion of men with MS have low~     testosterone levels. We propose a two-site clinical trial using topical testosterone gel as a~     treatment for MS-related fatigue in men with progressive MS who have low or low-normal~     testosterone levels.~   "
43353|NCT02999334|"~     The quality of antenatal care (ANC) in much of sub-Saharan Africa is constrained by severe~     resource and staffing shortages. The investigators adapted and piloted an evidence-based~     model of group antenatal care as an innovative way to improve ANC service delivery and~     increase health promotion. This pilot will be conducted in Malawi and Tanzania and will~     provide data to prepare for a large randomized controlled trial to document the impacts that~     group antenatal has on perinatal health outcomes. This study will ultimately inform policy~     and practice aimed at improving quality of antenatal care through respectful and~     woman-centered care to pregnant women.~   "
43293|NCT03000114|"~     Dupuytren's disease is a non-curative, progressive disorder leading to function-impairing~     deformities of the hand. Although numerous treatments exist, the most common and widely~     accepted therapy is removal of diseased fascia. Surgery is limited by prolonged recovery~     time, and many patients require multiple surgeries throughout their life as the disease~     progresses, with repeat surgeries increasing the risk of complications.~      Long recovery times and need for repeat surgeries has renewed interest in minimally invasive~     treatments for Dupuytren's disease. Percutaneous needle aponeurotomy (PNA) allows for rapid~     improvement in finger extension with minimal recovery time. The FDA approved collagenase~     clostridium histolyticum injection for Dupuytren's disease in 2010, which also allows for~     rapid increase in finger extension, also with minimal recovery time. Currently there is only~     one small study comparing PNA and collagenase injection (CI) that suggests similar outcomes~     in both treatments. Both treatments are minimally invasive, requiring minimal time off work~     and post-procedure pain. The main barrier to widespread adoption of CI is cost, particularly~     in patients with multiple areas of disease requiring treatment. The project proposed will~     compare these two methods for treating Dupuytren's disease.~      Approximately 334 participants will be recruited from patients referred for treatment to hand~     surgeons trained in CI and PNA at two Calgary, AB hospitals. Need for treatment will be~     determined in the usual fashion, and the option for entry into the study will be proposed to~     patients meeting inclusion/exclusion criteria. Participants will be randomized into either~     the PNA or CI treatment group. The surgeon will not be blinded to the procedure group;~     however, the therapist measuring outcomes will be, and the study participants will need to~     not divulge to the therapists which group they are in.~      Both procedures are performed under local freezing, and range from 5-20minutes. PNA involves~     the surgeon freezing the skin over the Dupuytren's cord, then using a small gauge needle~     inserted under the skin to cut the cord. This is repeated up the length of the cord to weaken~     it, allowing the surgeon to extend the finger and rupture the cord. CI involves the injection~     of collagenase (Xiaflex®), directly into the Dupuytren's cord. The patient then returns to~     see the surgeon within one week, has freezing placed in the hand, and the affected digit is~     extended to rupture the already weakened cord.~      The patient will be required to present to the hand therapist team for measurements of joint~     angles before and after the assigned treatment is performed. In order to measure treatment~     efficacy, study participants will be required to return for measurements of treated joints~     every 6 months. Lastly, participants will need to inform the performing surgeon or therapist,~     at follow-up visits of any complications they experience.~   "
43294|NCT03000101|"~     The aim of this research is to study the effects of a pomegranate juice on calprotectin~     levels in patients suffering of inflammatory bowel diseases (IBD) in clinical remission.~     Fecal calprotectin levels, surrogate marker of mucosal inflammation, will be measured from~     baseline to 12 weeks later (end of intervention). Systemic and mucosal changes of biochemical~     and molecular inflammatory response markers will be also assessed.~   "
43295|NCT03000088|"~     The McGrath videolaryngoscope (VL) provides excellent laryngoscopic views, but directing an~     endotracheal tube is not easy, so routine using of stylet is recommended. The goal of this~     study is to determine the appropriate angle of stylet by comparing time to intubation (TTI).~   "
43296|NCT03000075|"~     This is a randomized double blind, double dummy, placebo controlled, parallel design study~     that is being performed to assess the safety and efficacy of BI 655066 (risankizumab).~   "
43297|NCT03000062|"~     In this study the investigators want to explore the feasibility and effect of a simple~     intervention provided by primary care physicians on treatment for overweight in general~     practice. Regular patients visiting their ordinary family physician will be asked for~     participation if they comply with the inclusion criteria. If so, they will follow a detailed~     food list for 12 months with regular visits to the doctor. At each visit, the participating~     patients will be asked about their progress on weight loss and all measurements will be made.~     Simultaneously a control group of primary care physicians will also recruit patients that~     fulfill the inclusion criteria. These patients will also provide data that will serve as~     Control to the intervention group.~   "
43298|NCT03000049|"~     With a completely bedside blood culture diagnostics system (BACTEC blood culture system in~     combination with the Accelerate ID/AST System) it is possible to optimize the initial~     antimicrobial therapy in patients with sepsis and septic shock.~      Prospective observational, open-label mono-center study to compare a completely bedside blood~     culture diagnostics system (BACTEC blood culture system in combination with the Accelerate~     ID/AST System and Curetis Univero System) with standard blood culture diagnostics in patients~     with sepsis or septic shock.~   "
43299|NCT03000036|"~     Twenty-seven breast cancer women without heart failure, underwent CMR imaging (3T-Achieva,~     Philips) before and 3 times serially after 4-cycles of adjuvant DOX (60mg/m2). CMR assessed~     left ventricular (LV) ejection fraction (EF), T1 mapping pre and post gadolinium and late~     gadolinium enhancement imaging. Biomarkers were obtained before and 72 hours after each~     DOX-cycle.~   "
43300|NCT03000023|"~     The study is both qualitative and quantitative, gathering patient's perceptions of HCV~     treatment benefits before and after HCV treatment by administering surveys and conducting~     in-depth qualitative patient interviews. The study seeks to understand all anticipated and~     actual benefits patients perceive before and after viral eradication.~   "
43301|NCT03000010|"~     The purpose of this study is to evaluate the effectiveness of incisional vacuum-assisted~     closure (VAC) therapy in the prevention of infection after posterior spinal fusion for~     pediatric neuromuscular scoliosis, in comparison to a regular gauze bandage.~   "
43302|NCT02999997|"~     Parkinson's disease (PD) is typically associated with cognitive and movement related~     functional disabilities. One commonly described cognitive complaint is the ability to do~     several things simultaneously, defined as dual or multiple tasking. The Ronnie Gardiner~     Method (RGM) is a rhythm and music based rehabilitation intervention that includes components~     that will train this ability specifically in addition to postural control, motor learning,~     movement ability and general cognitive function. The aim with the present randomized~     controlled single-blinded trial is to evaluate the RGM with main focus on dual-task~     performance, compared to a control group, in individuals with PD. The control group will~     continue with everyday activities, including ordinary exercise activities, with no additional~     activity. Both groups will be evaluated pre-, post-, and after 3 months post intervention.~     Following outcome measures will be analyzed:~        1. dual task performance (motor-motor, and motor-cognitive)~        2. level of physical activity, motor function and balance~        3. cognitive function including memory and spatial function~        4. health-related quality of life, fear of falling, and freezing of gait~        5. qualitative interviews from focus group discussions~   "
43354|NCT02999321|"~     Assess the impact of chronic use of aspartame on glycemia, appetite and body composition.~   "
43398|NCT02998749|"~     The aim of our retrospective clinical study was to examine the association between agonal~     breathing, return of spontaneous circulation (ROSC), and long-term survival. A secondary aim~     was to examine role of basic life support (BLS) and response time. Our hypothesis is that~     agonal breathing has positive effects on both primary and secondary endpoints.~   "
43399|NCT02998736|"~     The purpose of this study is to determine if giving Cialis for 5 days prior to surgery, on~     the day of surgery along with the influenza vaccine and Cialis 10 days after surgery will~     have an affect at the cell level for decreasing the chances of the spread of disease post~     surgery.~   "
43303|NCT02999984|"~     This is a prospective, non-randomized, single-cohort, longitudinal, single-center, clinical~     study designed to assess the efficacy and safety of a cryopreserved formulation of OTL-101~     (autologous CD34+ hematopoietic stem/progenitor cells transduced ex vivo with EFS LV encoding~     for the human ADA gene) administered to ADA-SCID subjects between the ages of 30 days and 17~     years of age, who are not eligible for an HLA-matched sibling/family donor and meeting the~     inclusion/exclusion criteria. The OTL-101 product will be infused after a minimal interval of~     at least 24 hours following the completion of reduced intensity conditioning. For subjects~     who have successfully received the OTL-101 product, PEG-ADA ERT will be discontinued at~     Day+30 (+/-3) after the transplant. After their discharge from hospital, the subjects will be~     seen at regular intervals to review their history, perform examinations and draw blood~     samples to assess immunity and safety.~   "
43304|NCT02999971|"~     The objective of this study is to investigate the relative effectiveness of CCT on water~     versus on land in stroke patients. Additionally, the study will to determine if there are~     differences in the results obtained, between two CCT programs in the following parameters:~     gait, balance and dexterity~   "
43305|NCT02999958|"~     Upon collection, human oocytes are fertilized and culture up to the blastocyst stage,~     followed by transfer and / or cryopreservation. Culture media systems have been developed~     that support each step of this process. Although these culture media systems try to mimic the~     natural environment, several components of the in-vivo situation are not present in today´s~     media. One such component is anti-oxidants that may protect embryos against damage by~     reactive oxygen species.~      This investigation aims to compare blastocyst development using 2 different types of culture~     media systems, one of which contains antioxidants. Patients having at least eight oocytes and~     meeting other inclusion criteria can be included in this investigation.~      It is a prospective randomized multicenter study randomly dividing oocytes into two groups~     and assessing parameters of embryo development from fertilization up to blastocyst formation~     until day six. Embryos with acceptable developmental characteristics can be transferred into~     the uterus or cryopreserved for later use.~      The investigation is designed as a superiority study comparing utilization rate of~     blastocysts per normally fertilized oocyte using both media systems. In patients receiving~     embryo transfer in the fresh treatment cycle, detection of clinical pregnancy by ultrasound~     after 12 weeks gestation is the final endpoint of the investigation.~   "
43306|NCT02999945|"~     In this prospective randomized controlled multi center trial the investigators stratify Very~     Low Birthweight  (VLBW)-infants with growth retardation in small for gestational age (SGA)~     or intrauterine growth restricted (IUGR) - infants and aim to investigate the impact of a~     nutritional management with enhanced nutrients from discharge up to the 52nd week of~     postconceptional age on growth, body composition, metabolic programming, metabolomics,~     microbiome and long term neurodevelopmental outcome. In this study, the investigators will~     evaluate the difference in metabolic profiles of SGA and IUGR preterm infants. The~     investigators will further longitudinally assess, how different nutritional interventions~     affect the altered pathways in the first year of life and identify, in combination with data~     available from metabolic markers, microbiome and breast milk analysis, potential pathways~     resulting in increased disease risk later in life.~   "
43307|NCT02999932|"~     Investigators hypothesized that a relative low SpO2 directed oxygen therapy would reduced the~     mortality in patients staying longer than 72 hours in ICUs.~   "
43308|NCT02999919|"~     Post-dural puncture headache (PDPH) is seen more frequently in pregnant women due to stress,~     dehydration, intra-abdominal pressure, and insufficient fluid replacement after delivery.~     Obesity protects against PDPH in pregnant women; increased intra-abdominal fat tissue reduced~     cerebrospinal fluid leakage by increasing the pressure in the epidural space. Therefore, this~     study investigated the influence of body mass index (BMI) on PDPH in elective caesarean~     section patients in whom 27G spinal needles were used.~   "
43309|NCT02999906|"~     This is a multicenter, randomized (2:1 oral treprostinil: placebo), double-blind,~     placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are~     currently receiving background dual therapy (ambrisentan, tadalafil) for at least 30 days at~     randomization for their PAH. Once randomized, subjects will return for 5 study visits up to~     Week 28 during the blinded period. After the Week 28 Visit, eligible subjects will transition~     to the open-label period of the study for up to 20 weeks.~   "
43310|NCT02999893|"~     The purpose of this study is to determine whether APR-246, 5-FU and cisplatin are safe and~     effective in the treatment of platinum resistant oesophageal cancer.~   "
43311|NCT02999880|"~     the importance of this study is to evaluate the clinical performance of direct anterior resin~     composite restoration constructed using innovative esthetic dual-shade technique and another~     restoration constructed using polychromatic natural layering technique with various finishing~     and polishing steps.~      The benefit from carrying out this study is to help the practitioners to decide the most~     suitable, easy, perfect technique to provide an optimally aesthetic, long lasting with~     superior clinical performance direct anterior resin composite restoration.~   "
43312|NCT02999867|"~     This study is designed to evaluate short term effect of triticale, mung bean and adzuki bean~     intervention for health improvement in patients with type 2 diabetes.~   "
43313|NCT02999854|"~     The primary objective of this study is to compare safety and efficacy of a haploidentical~     T-cell depleted HSCT and adjunctive treatment with ATIR101 versus a haploidentical T cell~     replete HSCT with post-transplant administration of high dose cyclophosphamide (PTCy) in~     patients with a hematologic malignancy. An additional objective of the study is to compare~     the effect of the two treatments on quality of life.~   "
43314|NCT02999841|"~     Focusing on newly diagnosed type 2 diabetes participants with overweight and obesity (24kg/m2~     ≤ body mass index ≤ 30kg/m2).~      50 participants per arm (acarbose & lifestyle combination / vildagliptin & lifestyle~     combination), using abdominal computed tomography scans and other methods to evaluate the~     effects of acarbose and vildagliptin on visceral fat distribution in overweight and obesity~     patients with newly diagnosed type 2 diabetes.~   "
43410|NCT02998593|"~     This study is a prospective double blind randomized controlled trial to investigate the~     effect of red and white bahman on semen parameters, sexual hormones and DNA defragmentation~     in idiopathic oligospermic men .Include patients will take the medicine and placebo in~     different two case and control groups for 3 month and semen parameters and other variants at~     the start and end of study.~   "
43315|NCT02999828|"~     Enterovirus 71 (EV71), a major pathogen causing hand-foot-and-mouth disease (HFMD) worldwide,~     is a member of the Human Enterovirus species A, family Picornaviridae. Its infection~     occasionally leads to severe diseases and death, with central nervous system (CNS) damage.~      Recently, except of inactivated vaccine, several EV71 vaccine candidates have been evaluated~     in animals but no final results of clinical trials, such as attenuated vaccine, subunit~     vaccine.~      A formalin-inactivated EV71 vaccine (Human Diploid cell, KMB-17 Cell) has been finished phase~     I, II and III clinical trials and licensed by SFDA in China at Dec. 3, 2015. Based on the~     results of clinical trials, the protective efficacy of inactivated EV71 vaccine is 97%~     against HFMD caused by EV71. The phase IV clinical trial has been carried out from July 2016.~     The purpose of phase IV is to evaluated the safety and efficacy of the inactive EV71 vaccine~     in large scale population of Chinese children (from 6 to 71 months old).~   "
43316|NCT02999815|"~     To establish whether the addition of intrathecal tetanus antitoxin reduces the need for~     mechanical ventilation in patients with tetanus~   "
43317|NCT02999802|"~     This research seeks to better understand how cellular and molecular bases of changes~     associated with aging contribute to decreased function and increased incidence of disease.~     Specific mechanism in muscle responsible for anabolic resistance - a key component of~     sarcopenia and frailty - will be identified. The proposed research is relevant to public~     health because the discovery of new targets for interventions and novel therapeutics to~     improve muscle strength and function, prevent falls, and reduce physical dependency will~     improve the healthspan and quality of life in older adults by improving their physical~     function and ability to remain independent and healthy for a longer period of time.~   "
43318|NCT02999789|"~     To conduct a pilot test to estimate the effect of a novel reminder system in improving daily~     asthma controller medication adherence rates in children with monolingual Spanish-speaking~     guardians who have limited English Proficiency (LEP).~   "
43319|NCT02999776|"~     The purpose of this study is to assess the feasibility and safety of topical administration~     of etanercept via AFL micropores to psoriatic plaques in patients with mild to moderate~     plaque-type psoriasis.~      While a wide variety of therapeutic innovations to treat moderate-to-severe psoriasis~     (accounting for around 30% of the cases) become available each year, there are few~     innovations for topical therapies to treat mild/localized psoriasis (accounting for around~     70% of the cases). Given that only about half of the patients respond adequately to the~     current standard of care, the topical application of a fixed combination of calcipotriole and~     betamethasone, there is a medical need for better topical therapies.~      Etanercept has been used successfully to treat moderate-to-severe plaque-type psoriasis in~     children and adults for more than a decade. Its standard route of application is through~     subcutaneous injections. Different dosing regimens have been used: 1 x 50 mg or 2 x 50 mg per~     week as well as 1 x 25 mg or 2 x 25 mg per week. Under these regimens, etanercept has a~     well-established favorable long-term safety record, with injection site reactions (pain,~     swelling) the most frequently reported side effects. However, rare but serious side effects~     such as serious opportunistic infections resulting from immune system inhibition common to~     anti-TNF agents limit its systemic use to these patients. For this reason, a localized~     topical alternative route of administration would be desirable. However, the large molecular~     size and chemical nature of etanercept prevent it from crossing the epidermal barrier. A CE~     certified ablative fractional laser (AFL) device with Er:YAG source will be used to create~     micropores in plaques to allow local delivery of etanercept directly into psoriatic plaques.~   "
43320|NCT02999763|"~     Prospective, one-arm, baseline-controlled, clinical study for the evaluation of the SlimShape~     device for non-invasive abdominal fat and circumference reduction.~      Study subjects will undergo SlimShape treatments on the abdominal area.~   "
43321|NCT02999750|"~     The purpose of this study is to prospectively validate treatment benefit of an individualized~     treatment concept based on molecular profiling (MP) from paraffin-embedded tumor tissue~     sections obtained before the start of treatment (real time biopsy).~   "
43322|NCT02999737|"~     The injection of autologous platelet rich plasma (PRP) is a relatively novel therapy,~     generating interest across a wide variety of medical specialties, such as orthopedics,~     dentistry, ophthalmology, and dermatology. Several recently published studies have~     demonstrated efficacy in treating androgenetic alopecia (aka male or female patterned hair~     loss), but each varies in the treatment protocol, and there is no evidence-based data to date~     guiding the dosing parameters of and intervals between injection sessions. We propose a~     single-center, single-blinded randomized pilot trial to investigate the most beneficial~     number and frequency ('schedule') of necessary PRP injections in men and women with~     androgenetic alopecia.~   "
43323|NCT02999724|"~     Gabapentin is a medication used primarily to treat seizures and pain. Studies have shown that~     this medication can help reduce pain after surgery, including hysterectomy, where the uterus~     or womb is removed. Opioids are the first choice for pain medication administered after~     surgery, but carry significant side effects. Several studies have demonstrated that if~     patients are given gabapentin before surgery, they require less opioids after surgery.~     However, there have not been any studies examining gabapentin's effects on post-operative~     pain in urogynecologic surgery, which treats pelvic organ prolapse and urinary incontinence.~     Pelvic organ prolapse occurs when female pelvic floor supports have weakened and therefore~     patients experience a bulge or pressure in the vagina. Patients with these conditions are~     typically offered medical treatments, but some may require surgery, and this usually consists~     of vaginal hysterectomy, pelvic floor repair, and a mid-urethral sling to treat any~     concurrent urinary incontinence. Our study aims to look at the effect of gabapentin given to~     patients undergoing urogynecologic surgery on their pain levels after surgery, including the~     amount of opioid pain medication required. We hypothesize that the patients who receive~     gabapentin before surgery will require significantly less opioids.~      Over a six-month period, patients seen in Urogynecology clinics will be invited to~     participate in the study. Women who are already on gabapentin for other reasons, have an~     allergy to gabapentin, have a reason they cannot take gabapentin, or who cannot understand~     spoken English will be excluded from the study. After providing informed consent, they will~     be randomized to either receive gabapentin or a placebo pill. They will receive the standard~     surgical care, including the usual anesthesia for surgery and routine pain medications~     available after surgery. We will then compare the differences in opioid consumption in the~     first 24 hours after surgery as well as the time from the end of surgery to leaving to the~     recovery room and the length of recovery room stay between the gabapentin and placebo groups.~     We will also analyze the differences in anxiety, drowsiness, pain, and nausea as rated by the~     patients in each group.~   "
43324|NCT02999711|"~     Purpose of this study is to assess the safety and tolerability of multiple ascending~     subcutaneous doses of REGN3500 to moderate asthmatics.~   "
43325|NCT02999698|"~     The aim of this study is to evaluate the psychological impact of psoriasis or hidradenitis~     suppurativa on patients, in order to compare both pathologies.~   "
43327|NCT02999672|"~     This multicenter, non-randomized, Phase II study will assess the efficacy, safety, and~     pharmacokinetics of trastuzumab emtansine in participants with HER2 overexpressing locally~     advanced (unresectable and not treatable with curative intent) or metastatic urothelial~     bladder cancer (UBC), locally advanced (unresectable and not treatable with curative intent)~     or metastatic pancreatic cancer/cholangiocarcinoma with advanced disease where cure is no~     longer possible and where no other treatment options are available anymore. Participants will~     receive intravenous (IV) infusion of trastuzumab emtansine as Regimen A (2.4 milligrams per~     kilogram [mg/kg], weekly [qw]) or Regimen B (3.6 mg/kg, every 3 weeks [q3w]) until~     unacceptable toxicity, withdrawal of consent, disease progression (PD), or death, whichever~     occurs first. Based on tolerability and safety aspects, steering committee and Independent~     Data Monitoring Committee (iDMC) will decide on expansion of the study to include more~     participants with other carcinoma types.~   "
43328|NCT02999659|"~     The pupilometer determines the alteration of the pupil diameter after a defined light~     stimulus. In this study data is collected from pupilometer measurements of patients with an~     acute cerebral disease. The measurements take place during daily neurological routine~     examinations. The values are compared to outcomes resulting from pupilometer measurements~     done on patients having not an acute cerebral disease (e.g. cerebral aneurysm without~     symptoms). The study aims to establish the not invasive method of pupillometry for detecting~     neurological degradations early.~   "
43329|NCT02999646|"~     The purpose of this trial is to determine the efficacy of the immunotherapy with MVX-ONCO-1~     in patients with advanced head and neck squamous cell carcinoma. MVX-ONCO-1 consists of dead~     tumor cells from the patient itself and genetically modified cells within a capsule. The~     whole treatment takes 9 weeks. At weeks 1, 2, 3, 4, 6 and 8, the tumor cells are injected~     underneath the skin and two capsules are implanted for a week. At weeks 2, 3, 4, 5, 7 and 9~     the capsules are removed again. The patients are then followed-up for 5 years.~   "
43330|NCT02999633|"~     Primary Objective:~      To evaluate the efficacy of isatuximab.~      Secondary Objectives:~        -  To evaluate the safety profile of isatuximab.~        -  To evaluate the duration of response (DOR).~        -  To evaluate progression free survival (PFS) and overall survival (OS).~        -  To evaluate the pharmacokinetics (PK) of isatuximab in patients with T-ALL or T-LBL.~        -  To evaluate immunogenicity of isatuximab in patients with T-ALL or T-LBL.~        -  To assess minimal residual disease (MRD) and correlate it with clinical outcome.~   "
43331|NCT02999620|"~     To determine the fat losses in stool associated with alpha-CD use in healthy volunteers, as~     compared to placebo when consumed with a standardized radiolabeled fatty meal.~   "
43332|NCT02999607|"~     With this study we will be able to dose-dependently measure real-time glucose metabolism~     changes after non-invasively stimulating superficial parts of the dlPFC, a commonly used~     target in therapeutic tDCS applications. This will provide further insight if and how tDCS is~     capable to change one of most reliable parameters of brain metabolism.~   "
43333|NCT02999594|"~     Tramadol for labor analgesia: a low risk placebo controlled randomised control trial~   "
43334|NCT02999581|"~     The purpose of this study is to examine the effects of a pre-workout dietary supplement~     during resistance training on training adaptations.~   "
43335|NCT02999568|"~     The purpose of this study is to examine how different levels of physical activity impact the~     ovarian reserve during the pre-menopausal period~   "
43336|NCT02999555|"~     A molecular study of follicular fluid aspirated from ovarian follicles during routine in~     vitro fertilization treatment, after the eggs were identified and separated.~   "
43337|NCT02999542|"~     The researchers are conducting a research study to see whether listening to music during an~     operation will have a positive effect on the way that children wake up from~     surgery/anaesthetic. It is a common phenomenon where children wake up unhappy, irritated and~     screaming (known as emergence delirium). Research have shown that music decreases anxiety and~     pain. The researchers want to see whether music can also influence a child's behaviour after~     emerging from anaesthesia. In other words whether they will be more calm and cooperative~     after listening to music while they are asleep during surgery. Should music have a positive~     effect, anaesthesiologists may use it in future to improve care of patients coming for~     surgery.~   "
43338|NCT02999529|"~     Cancer patients are presented with a lot of information about their diagnosis and different~     treatment options, which can be confusing. The purpose of this study is to see if a simple~     video explanation of six words used to describe cancer treatment improves patient~     understanding of these words.~   "
43339|NCT02999516|"~     Subjects participate in a motor learning training with a special bicycle. The experimental~     group proceed with 15 minutes of physical training with the bicycle and 15 minutes of rest~     where they use motor imaginary. The control group proceed equal except for the motor~     imaginary intervention.~   "
43340|NCT02999503|"~     In this study the investigators aim to investigate the relationship between environmental~     factors, lifestyle and symptoms of Attention Deficit Hyperactivity Disorder (ADHD). Initially~     the investigators intend to measure the relationship between nutritional quality, exercise~     and sleep and ADHD symptoms. And then measure whether a change made in the diet can improve~     the symptoms of ADHD.~   "
43341|NCT02999490|"~     Clinical examinations are difficult to discriminate between vegetative state and minimally~     conscious state. the diagnostic and prognostic usefulness of neuroimaging methods has not~     been established in a clinical setting. we will do a forward study of PET imaging in~     disorders of consciousness patients, and validate with clinical assessments with the coma~     recovery Scale-Revised(CRS-R).~   "
43342|NCT02999477|"~     This research study is exploring chemotherapy in combination with immunotherapy (a therapy~     that uses the body's own immune system to control cancer) as a possible treatment for hormone~     receptor positive breast cancer.~      The interventions involved in this study are:~        -  Pembrolizumab (MK-3475; Keytruda™)~        -  Nab-Paclitaxel (Abraxane~   "
43343|NCT02999464|"~     The purpose of this study is to compare the effects of qigong practice with fitness exercise~     on balance, fall-efficacy, physical functions, psychological wellbeing and quality of life of~     stroke survivors.~   "
44499|NCT02984345|"~     The present study will seek to quantify the muscle protein synthetic response to mycoprotein~     feeding, comparing it to milk protein as a gold standard and heavily researched positive~     control~   "
43345|NCT02999438|"~     Frailty is a complex biologic syndrome of diminished physiologic reserve that leads to~     decreased resistance to stressors and is associated with adverse health outcomes. The~     syndrome has been well studied in adults and is quantified by the Fried criteria, which are~     comprised of five components- slowness, weakness, self-reported exhaustion, shrinkage and~     diminished physical activity. The concept of frailty is novel in children. A study in young~     adult childhood cancer survivors demonstrated increased incidence of frailty in this~     population along with increased risk of morbidity and mortality. This suggests that frailty~     as a phenotype has relevance outside of the geriatric age group. Pediatric patients with~     single ventricle physiology, heart failure and pulmonary artery hypertension- all represent~     populations with significantly increased risk of mortality, morbidity and decreased quality~     of life. Currently, such patients are monitored outpatient by serial echocardiograms and~     blood work that only gives information about end organ damage. But there is no validated tool~     available to measure global infirmity in such children. Better understanding of the relevance~     and applicability of frailty in pediatrics may allow for identification of the most~     vulnerable pediatric cardiac patients and be of value in optimizing their clinical management~     and improving health outcomes.~   "
43346|NCT02999425|"~     The overall idea to be evaluated in this project is that educational activities providing~     top-notch knowledge on diet and physical activity may represent an additional benefit to the~     strategies aimed at decreasing lifestyle diseases in Serbian population of both young and~     mature age. The specific objectives of this project are:~        1. to develop user-friendly guidelines for physical activity and nutrition for two age~          group cohorts (K-12 and adults) of Serbia residents;~        2. to provide a brief educational intervention about nutrition and healthy lifestyles at~          school or work settings in each age group;~        3. to determine if an educational intervention would yield an additional benefit in the~          acquisition of knowledge on nutrition and physical activity;~        4. to promote and disseminate project results using popular media, non-professional and~          professional bodies and relevant events.~   "
43347|NCT02999412|"~     Background: Mismanaged prescribing and use of medication among elderly puts major pressure on~     current healthcare systems. Performing a medication review, a structured critical examination~     of a patient's medications, during hospital stay with active follow-up into primary care~     could optimise treatment benefit and minimise harm. However, a lack of high quality evidence~     inhibits widespread implementation. This manuscript describes the rationale and design of a~     pragmatic cluster-randomised, crossover trial to fulfil this need for evidence.~      Aim: To study the effects of hospital-initiated comprehensive medication reviews, including~     active follow-up, on elderly patients' healthcare utilisation compared to 1) usual care and~     2) solely hospital based reviews.~      Design: Multicentre, three-treatment, replicated, cluster-randomised, crossover trial.~      Setting: 8 wards with a multidisciplinary team within 4 hospitals in 3 Swedish counties.~      Participants: Patients aged 65 years or older, admitted to one of the study wards. Exclusion~     criteria: Palliative stage; residing in other than the hospital's county; medication review~     within the last 30 days; one-day admission.~      Interventions: 1, comprehensive medication review during hospital stay; 2, same as 1 with the~     addition of active follow-up into primary care; 3, usual care.~      Primary outcome measure: Incidence of unplanned hospital visits during a 12-month follow-up~     period.~      Data collection and analyses: Extraction and collection from the counties' medical record~     system into a GCP compliant electronic data capture system. Intention-to-treat-analyses using~     log-linear Poisson generalized linear mixed models and frailty models.~      Relevance: This study has a high potential to show a reduction in elderly patients'~     morbidity, contributing to more sustainable healthcare in the long run.~   "
43348|NCT02999399|"~     To determine whether glucobrassicin-rich Brussels sprouts can favorably modify the metabolism~     of the polycyclic aromatic hydrocarbon deuterated phenanthrene ([D10]phe) in current and~     former smokers~   "
43349|NCT02999386|"~     The clinical relevance of the observed stress induced hyperglycemia in trauma patients~     remains unclear. The earlier studies suggested the implications of cytokines in stress~     induced hyperglycemia and the outcomes after trauma. To date, there is little information~     available regarding the effect of diabetic hyperglycemia (occult or known) on outcomes after~     trauma and whether these patients represent a distinct group with differential outcomes when~     compared to those with stress-induced hyperglycemia. Herein, the purpose of this study is to~     identify the incidence of stress induced hyperglycemia as well as diabetic hyperglycemia in~     trauma patients and to investigate the association between proinflammatory cytokine levels~     and hyperglycemia in our trauma population.~   "
43350|NCT02999373|"~     About 37% of neonatal mortality are caused by infection worldwidely . Excessive application~     of broad-spectrum antibiotics increased drug-resistance, however does not decrease morbility~     and mortality of neonates. Based on the investigator' early in vitro experiments which found~     cord blood mononuclear cells can inhibit bacterial growth and reduce of drug-resistance,~     along with other studies conducted recently from other groups who have reported the~     successful use of umbilical cord blood mononuclear cells in animal sepsis.The investigator~     would like to investigate the effects of umbilical cord blood mononuclear cells on prevention~     effect of preterm infection.~   "
43351|NCT02999360|"~     The purpose of the study is to determine if speech therapy can be enhanced by Aerobic~     Exercise (AE). Investigators will use a single subject design to determine if aphasia therapy~     result in greater gains when combined with aerobic exercise.~   "
43352|NCT02999347|"~     The purpose of this study is to determine the interactions between pregnancy and urinary~     stress incontinence in women with a mid-urethral sling (MUS). The specific aims of the 2 sub~     studies are:~      Study 1:~      The main aims of Study 1 are to evaluate any potential impact on urinary stress continence~     after a pregnancy/delivery following MUS surgery, and to evaluate any potential differences~     in continence status based on the mode of delivery for these women.~      Study 2:~      The aim of Study 2 is to examine how obstetric factors may affect the degree of incontinence~     in women registered in The Norwegian female incontinence registry prior to surgical~     treatment. In addition, we want to explore if there are obstetric risk factors predicting~     failure of a MUS surgery performed after pregnancy/delivery.~   "
44500|NCT02984332|"~     The effect of unilateral lower limb immobilisation over one week on muscle atrophy~   "
44501|NCT02984319|"~     Acute effect of cherry concentrate consumption on flow mediated dilatation in healthy young~     men~   "
43355|NCT02999308|"~     In the past, due to economic and medical resource constraints, the hemophilia comprehensive~     care in China was suboptimal. The BCH data of both retrospective and prospective studies~     reveals that for 4-6y and 6-9y patients with severe hemophilia respectively: 45% and 82% of~     the patients have suffered from joint bleeding, with mean AJBR of 4.18 and 4.95; and 24.2%~     and 33.3% of them with AJBR>10 times, led to arthropathies and made their quality of life be~     heavy affected. Now, with the development of economy and medical science in China,~     prophylaxis regimens have been initiated in more and more children with hemophilia.~     Considering the difference between prophylaxis regimens, the frequency of joint bleeding was~     reduced significantly, the quality of life of hemophilia kids improved. An assessment scoring~     system for the appropriate validation of individualized prophylaxis treatment regimens are~     urgently needed.~      Before, the most important assessed indication for hemophilia prophylaxis was the frequency~     of joint bleeding. But increasing evidences are showing that there is a discrepancy between~     real joint damage and joint bleeding frequency. The single indicator of joint bleeding~     frequency is not sufficient to evaluate the joint status of hemophilia children.~      Under the World Health Organization's ICF guidelines, the assessment scoring system for~     selecting prophylaxis for children with hemophilia should include the tools currently~     available for assessment of structure/function of the joint, patient activities and patient~     participation in hemophilia healthcare. According to ICF of WHO, the most common bleeding~     parts are elbows, knees and ankles, therefore the assessment of children with hemophilia~     should include the evaluation of the structure, the function of these 6 Index joints, the~     capacity of activities and the capacity of participation of children. These will constitute a~     comprehensive hemophilia evaluation system.~      In China, exploration of the optimal and individualized prophylaxis regimen is urgent, and~     the comprehensive evaluation system should include joint structure and function, body's~     activities and individual participation, thus may be more appropriate for the individualized~     prophylaxis for Chinese children with hemophilia.~   "
43356|NCT02999295|"~     The main purpose of this study is to evaluate the safety and efficacy of the combination~     therapy of ramucirumab and nivolumab in participants with advanced or recurrent unresectable~     gastric or GEJ cancer.~   "
43357|NCT02999282|"~     In this randomized, double-blind, sham-controlled study, the investigators will evaluate the~     effects of frontal and prefrontal anodal transcranial direct current stimulation (tDCS) on~     neurophysiological parameters of cortical connectivity, assessed by transcranial magnetic~     stimulation (TMS), in asymptomatic subjects at risk and symptomatic patients bearing a~     pathogenic Progranulin mutation.~   "
43358|NCT02999269|"~     Electroconvulsive therapy (ECT) remains the gold-standard treatment for patients with~     depressive episodes. During a typical four-week ECT series, most depressive episodes will~     respond to treatment and people will improve their level of functioning (return to work or~     family). Independent of the antidepressant effect of ECT, many patients experience transient~     memory impairment. This investigation will examine the impact of one ECT parameter (pulse~     amplitude or current) on brain changes (structure of connections within the brain) and~     clinical outcomes. The goal of this investigation is to determine the optimal parameter for~     an individual patient that will maintain the clinical response (reduce depression severity)~     and minimize side effects (eliminate memory issues related to treatment).~   "
43359|NCT02999256|"~     The present study examined the effect of Montmorency tart cherry juice and FATMAX (intensity~     eliciting maximal fat oxidation) exercise on fat oxidation rates, body composition and~     blood-based cardio-metabolic markers. Participants received both Montmorency tart cherry~     juice and placebo in a random counterbalanced order for 20 days. Outcome variables were~     measured immediately pre- and post-supplementation and 10 days after the onset of~     supplementation. It was hypothesised that Montmorency tart cherry juice would increase fat~     oxidation during exercise, reduce body fat percentage and improve cardio-metabolic markers.~   "
43360|NCT02999243|"~     This randomized controlled trial (RCT) evaluates whether HIV self-testing (HIVST) facilitates~     sexual harm reduction and reduces HIV transmission among HIV-negative MSM in China.The~     intervention group will be offered HIVST kits plus harm reduction education, and followed 9~     month, while the control group will receive harm reduction educational material only.~   "
43361|NCT02999230|"~     This study will examine the mechanisms of action of probiotics and synbiotics for control of~     oral diseases, with a particular focus on exploring new strategies for caries prevention and~     treatment.~   "
43362|NCT02999217|"~     This 4-week prospective double blind anaemia management study evaluates the effect of~     high-dose postoperative intravenous iron vs placebo for patients after colorectal cancer~     surgery. Patients with preoperative levels of haemoglobin 90-120 g/l will be randomly~     assigned to receive either 1 g of intravenous iron or equal amount of saline postoperatively.~     Comparison will be based on the levels of haemoglobin, ferritin and other haematological~     parameters over time and profile of clinical recovery.~      The primary end point is that iron isomaltoside given postoperatively is superior to placebo~     in terms of increase and stability of levels of haemoglobin and other haematological~     parameters.~   "
43363|NCT02999204|"~     To evaluate in patients with chronic kidney disease the impact of two dosages of per os~     vitamin D3 supplementation (cholecalciferol) on large arterial stiffness (evaluated non~     invasively by pulse wave velocity and high-resolution echotracking system). We will also~     study arterial calcification (lateral abdominal radiography and echocardiogram), arterial~     remodeling (high-resolution echotracking system), endothelial function (evaluated by a~     non-invasive finger biosensor device), and bone remodeling (evaluated by serum biomarkers and~     bone mineral density).~   "
43364|NCT02999191|"~     The primary objective of this trial is to investigate the relative bioavailability of BI~     1467335, given as film-coated tablet compared to BI 1467335, given as oral solution. This~     assessment will be performed under fasted conditions. Furthermore, the effect of food on~     relative bioavailability of the tablet formulation of BI 1467335 will be investigated.~   "
43365|NCT02999178|"~     The aim of the current study is to investigate the efficacy and safety of nintedanib over 52~     weeks in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) defined as~     patients who present with features of diffuse fibrosing lung disease of >10% extent on~     high-resolution computed tomography (HRCT) and whose lung function and respiratory symptoms~     or chest imaging have worsened despite treatment with unapproved medications used in clinical~     practice to treat ILD. There is currently no efficacious treatment available for PF-ILD.~     Based on its efficacy and safety in Idiopatic Pulmonary Fibrosis (IPF), it is anticipated~     that Nintedanib will be a new treatment option for patients with PF-ILD.~   "
43380|NCT02998983|"~     This clinical trial will be carried out in children diagnosed with high-risk neuroblastoma~     that have achieved a complete or very good partial response after standard therapy. An~     additional cohort of children who could not achieve these response criteria or that relapsed~     after standard therapy but do not have progressive disease will receive Racotumomab together~     with metronomic chemotherapy.~      The main objectives of this study are to determine the immune response after one-year~     duration immunization with Racotumomab, to describe the response of Racotumomab therapy in~     minimal residual disease (MRD) in bone marrow and to describe the toxicity profile of~     Racotumomab.~   "
44502|NCT02984306|"~     Examining the effect of four weeks of cherry powder supplementation on flow mediated~     dilatation~   "
43366|NCT02999165|"~     The purpose of this study is to assess whether two methods of breathing support in babies~     called 'Humidified High-Flow Nasal Cannula' oxygen (HHFNC) and 'nasal Continuous Positive~     Airways Pressure' (nCPAP) are compatible with breastfeeding. Many babies who are premature or~     unwell after birth require help with their breathing. This is often achieved by blowing a~     continuous flow of air through the nose and down into the lungs in order to reduce the amount~     of effort the baby needs to inflate the lungs during breathing.~      Currently some centres allow babies to breastfeed whilst undergoing breathing support whilst~     other centres do not in case there is an increased risk of choking or other harmful events.~     In the latter case, babies are fed using a nasogastric tube (NGT) that runs from the baby's~     nostrils into their stomach.~      At this centre, babies are allowed to breastfeed whilst simultaneously on either HHFNC or~     nCPAP. This is because the concerns over the choking risk are not evidence based. This study~     aims to conclusively prove that thisfeeding protocol is safe and then to expand into other~     areas of research to find out the following:~        -  Whether breastfeeding during nCPAP or HHFNC leads to babies establishing full~          breastfeeding sooner (and subsequently reduce the length of their stay in hospital)~        -  What the effects of breastfeeding of nCPAP or HHFNC are on a baby's parents (e.g.~          whether it enhances bonding)~        -  If nCPAP and HHFNC have different effects on breastfeeding As part of this study the~          investigators will observe stable babies on nCPAP or HHFNC during breastfeeding~          episodes. The investigators will monitor the babies for signs of distress or instability~          and whether they are more stable when breastfeeding is not occurring. This will be~          compared to an episode where the same baby is fed by NGT to see which technique is~          better.~   "
43367|NCT02999152|"~     The aim of this study is to confirm in humans the relevance and the kinetics of radio-induced~     bio-markers in plasma and urines, previously described at the preclinical stage.~   "
43368|NCT02999139|"~     Participants who train at The Micheli Center for Sports Injury Prevention, will undergo~     testing of muscular strength, range of motion, flexibility, aerobic capacity and muscular~     endurance. They will complete training with a certified trainer and injury prevention~     specialist until their specific goals are meet. Upon completion of training, they will fill~     out an injury questionnaire every three months for five to ten years.~   "
43369|NCT02999126|"~     The purpose of this study is to determine if a slow stepwise propofol TCI induction with~     Marsh model (Ke0 0.26), allows for an accurate estimation of the effect site concentration~     required for maintenance of the general anesthesia, with propofol and remifentanil, in adult~     populations older and younger than 65 years of age.~   "
43370|NCT02999113|"~     To explore to what extent shared mental models (SMM) occur within the Video-Assisted~     Thoracoscopic Surgery (VATS) teams in a cardiothoracic surgery setting. Additionally, to~     establish whether the VATS team's SMM is associated with the surgeons' technical skills,~     procedural specific times, per-operative bleeding, or patient characteristics~   "
43371|NCT02999100|"~     The study will evaluate a stable, dry-powder formulation of oxytocin, with the goal of~     reducing post-partum hemorrhage morbidity and mortality in resource poor settings. This study~     is being conducted to further assess safety and tolerability of inhaled oxytocin, and to~     characterize the drug levels of inhaled (IH) oxytocin when compared to oxytocin administered~     as standard of care. Two groups of subjects will be enrolled. Group 1 will enroll pregnant~     women, who will be randomized to receive either IH or intramuscular (IM) oxytocin as active~     management of the third stage of labour (after the baby is born). Group 2 will enroll~     non-pregnant women of childbearing potential, who will receive IH oxytocin and intravenous~     (IV) oxytocin in a cross over design over two dosing sessions This group will evaluate the~     safety and tolerability of IH and IV oxytocin.~   "
43372|NCT02999087|"~     The purpose of this study is to demonstrate that treatment with avelumab in combination with~     RT-cetuximab is superior to standard of care (SOC) cisplatin-RT and/or to SOC RT-cetuximab~     alone in terms of progression-free survival (PFS) in front-line patients with locally~     advanced SCCHN.~   "
43373|NCT02999074|"~     The BENEFIT-Study is a randomized controlled 3-arm intervention trial investigating the~     currently discussed hypothesis that exercise concomitant to chemotherapy (CTx) may have a~     beneficial effect on cancer prognosis by boosting the anti-tumoral effect of the cytostatics~     or by enhancing therapy compliance. This hypothesis is based on pre-clinical and exploratory~     clinical trials. Breast cancer patients scheduled for neoadjuvant CTx will be randomized to~     either a resistance training or an aerobic training concomitant to the neoadjuvant CTx, or a~     waiting list control group that will get no exercise intervention during neoadjuvant CTx~     (i.e. usual care) but will exercise after breast surgery. The primary study endpoint is the~     tumor size. Further, the effects of resistance and aerobic exercise on the~     clinical-pathologic stage (CPS-EG) score, the pathological complete response (pCR),~     tolerability and compliance to CTx, physical fitness, patient reported outcomes such as~     fatigue, sleep problems, quality of life, depressive symptoms, anxiety and pain, as well as~     cognitive function, and selected biomarkers will be investigated.~      A confirmation of the study hypothesis would be a strong argument for patients to engage in~     exercise as early as during neoadjuvant CTx. The trial will also provide evidence-based~     guidance for patients regarding type and timing of training.~   "
43374|NCT02999061|"~     The purpose of the study is to determine the prevalence of dental caries in preterm birth~     children aged 2-5 years in primary dentition.~   "
43375|NCT02999048|"~     The purpose of this study is to determine whether panax notoginseng saponins are effective in~     the treatment of Hypertensive Intracerebral Hemorrhage Patients.~   "
43376|NCT02999035|"~     A new liquid jet aesthesiometer prototype was developed with the aim to measure ocular~     surface sensitivity by employing a liquid jet.~      This study aims to validate this new prototype by means of correlating its measurement with a~     previously validated air jet aesthesiometer, the non-contact aesthesiometer (NCCA; by Murphy~     et al. 1996) and by exploring the repeatability of ocular surface sensitivity measurement.~   "
43377|NCT02999022|"~     This is a study designed to see if a low dose of Lithium treatment, taken for 2 weeks, can~     improve fracture healing and improve patients' function and productivity.~   "
43378|NCT02999009|"~     The purpose of this study is to review the performance and success rate of an FDA approved~     cementless hip replacement part called the Trident II Tritanium Acetabular Shell. The study~     will specifically look at the need to revise the hip replacement after 5 years. This will be~     compared to how much this happens in patients who have hip replacement with similar~     cementless acetabular shells.~   "
43379|NCT02998996|"~     The main purpose of the this study is to evaluate the safety and tolerability of Immunose™~     FLU based on Endocine™ and quadrivalent influenza antigen.~   "
43395|NCT02998788|"~     This is an prospective study conducted in a Chinese heart failure population. The study~     investigates the effects of cardiovascular disease risk factors such as lifestyle~     behaviors,biomarkers and intermediate diseases on heart failure prognosis.~   "
43381|NCT02998970|"~     The purpose of this study is to evaluate the effects of Empagliflozin on cardiac structure,~     function and circulating biomarkers in patients with Type II diabetes. Empagliflozin~     (anti-hyperglycemic agent), approved by Health Canada and the FDA for the treatment of Type~     II diabetes, demonstrated a reduction in cardiovascular deaths and heart failure from a~     previous post-marketing clinical trial. The use of empagliflozin to treat patients with~     diabetes and heart disease has been approved by Health Canada. However, the process by which~     it may give this beneficial effect remains unclear and needs further investigation.~     Therefore, the aim of this study is to provide a fundamental understanding of the mechanistic~     basis by which Empagliflozin could provide its potential cardio-protective effects by~     employing the use of Cardiac Magnetic Resonance Imaging (CMRI).~   "
43382|NCT02998957|"~     Introduction:~      Chronic obstructive pulmonary disease (COPD) presents with a gradual reduction and little~     bitterness reversible airflow causing shortness of breath, chronic cough and sputum abnormal.~     Patients with COPD often suffer exacerbations of their symptoms, particularly dyspnea,~     causing hospital admissions. Recent studies have shown that acupuncture stimulation~     transcutánea (AcuTENS) Dingchuan point (EX-B1) could help reduce dyspnea in patients with~     COPD.~      Objective:~      The aim of this study was to evaluate the possible utility of adding to the usual treatment~     stimulation AcuTENS in COPD patients admitted with severe dyspnea.~      Methodology:~      Patients who agree to participate will be randomly divided into two groups. The intervention~     group will receive a daily treatment, during the period of hospitalization, 45 minutes~     stimulation at acupuncture point AcuTENS Dingchuan (EX-B1), while the control group performed~     the same procedure with a device TENS simulated. The extent of dyspnea in both groups as well~     as the number of days of hospitalization and the number of drugs consumed.~   "
43383|NCT02998944|"~     This study aimed to explore the associations between constitutions of traditional Chinese~     medicine (TCM) and common disease (CD). A large-scale, community-based, cross-sectional study~     was performed to investigate the associations. A total of 3748 participants were available~     for analysis in this study. The assessment of constitution of TCM was based on~     recommendations of Association Chinese Medicine in China. In this study, the diagnosis of CD~     was based on self-reported medical history. The associations were analyzed using univariate~     and multivariable logistic regression (MLR).~   "
43384|NCT02998931|"~     Glutamine supplementation has beneficial effects on morbidity and mortality in critically ill~     patients, possibly in part through an attenuation of the proinflammatory cytokine response~     and a Immune function. In this trial intensive care unit patients with enteral feeding will~     receive either enteral glutamine or maltodextrin as placebo for 28 days.~   "
43385|NCT02998918|"~     Polyphenol supplements, including curcumin and resveratrol, are known to decrease~     inflammation, but previous polyphenol supplements were poorly absorbed and thus their effects~     were reduced. A new phytosome formulation coats the supplements and allows them to be better~     absorbed. The purpose of this study is to examine the acute (1-hr) and short-term (1-week)~     effects of two different phytosome-formulated polyphenol supplements on inflammation. The two~     supplements that will be used are: 1) PolyResveratrol and 2) Curcumin.~   "
43386|NCT02998905|"~     To determine the feasibility of a controlled trial examining the efficacy and safety of~     non-vitamin K antagonist oral anticoagulants (NOACs) compared with ASA for stroke prevention~     in patients with a high-risk of atrial fibrillation and previous intracerebral hemorrhage.~   "
43387|NCT02998892|"~     Population studies suggest that time spent in sedentary behaviors is associated with~     all-cause mortality including obesity, diabetes, and cardiovascular diseases, independent of~     time spent in exercise. Frequent interruptions to sedentary time are however beneficially~     associated with metabolic health outcomes, even in individuals who exercise regularly. The~     goal is to use integrative approach to understand the biological mechanisms that underlie~     these associations in a longitudinal intervention study in overweight sedentary adults. The~     investigators believe that the proposed study will provide an initial evidence base for the~     health benefits of breaking up prolonged sitting with short bursts of activity. This~     innovative strategy may be more effective at combating the adverse effects of sedentary~     behaviors than more traditional approaches.~   "
43388|NCT02998879|"~     The main objectives of the study are to evaluate safety and efficacy of repeated treatment~     with recombinant human alfa-mannosidase of patients with alfa-mannosidosis aged less than 6~     years~   "
43389|NCT02998866|"~     To determine the correlation between rate of temperature decline and nadir cryoballoon~     temperatures rate of temperature decline and nadir esophageal temperatures during pulmonary~     vein isolation.~   "
43390|NCT02998853|"~     Reliability of 3D angio QFR functional evaluation of all non culprit lesions >50% in STEMI~     patients during first acute procedure~   "
43391|NCT02998840|"~     The purpose of this study is to evaluate and compare the efficacy of B244 in treating~     patients with hypertension.~   "
43392|NCT02998827|"~     The effectiveness of thalidomide in treating inflammatory bowel disease has been widely~     recognized. Meanwhile, many serious adverse drug reactions were notified， but no reports on~     ovarian reserve function.Therefore, this study was to investigate the influence of~     thalidomide on function of ovarian reserve.~   "
43393|NCT02998814|"~     The purpose of this study was to evaluate the retention rates of a fissure sealant placed~     using different adhesive protocols over 24 months.Twenty-four subjects with no restoration~     and caries received fissure sealants (Clinpro™Sealant, 3M/ESPE) placed with different~     adhesive protocols. A total of 292 sealants (73 for each group) were placed. The sealants~     were placed as follows; a-without adhesive (acid-etch only), b-with an etch-and-rinse~     adhesive (SingleBondTM), c-with a self-etch adhesive (AdperTMEasyBond), d-with~     acid-etch+self-etch adhesive (AdperTMEasyBond) by two previously calibrated dentists using a~     table of random numbers. Two other calibrated examiners, independently evaluated the sealants~     at baseline and at 6-, 12-, 18-, and 24-month recalls. Each sealant was evaluated in terms of~     caries formation being present or absent and retention using the following criteria:~     1=completely retained, 2=partial loss, and 3=total loss. The Pearson χ2 test was used to~     evaluate differences in retention rates among the sealants for each evaluation period.~   "
43394|NCT02998801|"~     To construct and evaluate an immersive 3D simulation to familiarize patients with the~     pre-operative experience, and investigate whether A) immersive 3D virtual reality video can~     reduce pre-operative anxiety, and B) how this approach compares to current practice of~     viewing traditional educational videos.~   "
43400|NCT02998723|"~     Attrition of skills after basic life support (BLS) training is common. Psychology studies~     have established that for basic memory recall tasks, spaced learning strategies improve~     retention. Spaced learning is often organized as a refresher or 'booster' course after~     initial training. This study aims to investigate if this principle holds true for BLS skills,~     which require rapid memory recall and efficient deployment of procedural skills while under~     time pressure.~   "
43401|NCT02998710|"~     The purpose of the study is to characterize the clinical course of Cystathionine~     Beta-synthase Deficiency Homocystinuria (CBSDH) in pediatric and adult patients under current~     clinical management practices~   "
43402|NCT02998697|"~     The purpose of this study is to determine the efficacy of Ferrous Sulphate (FS) tablets in~     improving iron stores and functional capacity in HF patients with Iron Deficiency Anemia~     (IDA).~   "
43403|NCT02998684|"~     This study will examine whether brain stimulation paired with social skills learning can help~     teenage boys with autism learn how to make and keep friends. Brain stimulation can enhance~     learning in some people. This study involves enrolling in a 14-week training program where~     teenage boys with autism interact in small groups and learn social skills. During the 14-week~     program participants will receive active brain stimulation, or non-active stimulation~     (placebo). Before and after this training, MRI scans will be taken to see whether the~     training with active brain stimulation made a different in brain activation.~   "
43404|NCT02998671|"~     The study is designed primarily to assess preliminary efficacy and safety of CJM112 in~     patients with moderate to severe inflammatory acne and to determine if CJM112 has an adequate~     clinical profile for further clinical development. In addition, sustainability of response~     and dose relationship will be explored.~   "
43405|NCT02998658|"~     The aim of this study is to estimate whether the use of the barbed suture facilitates~     laparoscopic suturing of the vaginal cuff during total laparoscopic hysterectomy.~   "
43406|NCT02998645|"~     This is a two-part study, interventional Phase II, single-arm, multicenter, open-label study~     to investigate the efficacy and safety of a combination regimen of eltrombopag and~     cyclosporine in patients with severe aplastic anemia (SAA) as first line therapy and an~     extension with up to 60-months follow-up. All patients will receive eltrombopag for 6 months~     with cyclosporine. Patients who respond (who had overall hematologic response by 6 months)~     will continue tapering down cyclosporine for up to 30 months and will be followed up for a~     post-treatment follow-up up to 60 months by regular clinic visits. Patients who do not have~     an overall hematologic response (non-responders) by the end of 6 month time point will be~     discontinued from the treatment and will be followed up for non-responder post-treatment~     follow-up up to 60 months.~      The usage of eltrombopag and cyclosporine combines two therapies with different modes of~     action. Cyclosporine acts as an immunosuppressant and eltrombopag acts as a stimulator of~     bone marrow progenitor cells. Given that SAA is currently viewed as having an autoimmune~     pathogenesis resulting in bone marrow progenitor cell destruction, the combination of~     eltrombopag and cyclosporine is attractive. Preliminary experience with their combined use~     appears favorable, with no untoward toxicity observed to date.~   "
43407|NCT02998632|"~     -  Patients will be diagnosed to determine whether they are eligible for the inclusion~          criteria of this study or not. Patients who are eligible will start their surgical~          treatment in the next visit after radiographic and surgical site evaluation.~        -  On the day of surgery, each patient will be assigned to either intervention or control~          group, the patients will receive inferior alveolar nerve block and long buccal nerve~          anesthesia. Future implant site will be planned, an incision will be made and flap will~          be reflected along the defective ridge.~        -  Implant fixture/s will be inserted in the previously planned site. Uncovered fixture~          threads and bone defect will be covered by MPM or autogenous bone graft.~        -  In the control group, autogenous particulate bone graft will be used for vertical~          augmentation and covered with titanium reinforced membrane. In the intervention group,~          MPM (Mineralized plasmatic matrix) will be used.~        -  Edges will be approximated, Sutures will be placed.~        -  Osstell instrument will be used to measure and record fixture primary stability in ISQ~          units.~        -  Patients will be referred to the fixed prosthodontics department for placement of the~          crowns after ensuring success of osseointegration and implant stability (after 4~          months).~        -  Patients will evaluate their overall satisfaction after fitting the final prosthesis~          using a questionnaire at 9 months.~        -  After 9 months, CBCT will be performed to evaluate augmented bone height to be compared~          with the bone height previously recorded in CBCT.~        -  Osstell instrument will be used to evaluate the implant stability ratio in ISQ unit to~          be compared to the ratio recorded before.~   "
43408|NCT02998619|"~     Men with high risk prostate cancer who underwent radiotherapy of the prostate/seminal~     vesicles or underwent postoperative radiotherapy including pelvic lymph nodes between 2010~     and 2016 are analyzed retrospectively. The aims are to estimate progression-free survival as~     well as toxicity according to CTCAE v4.03.~   "
43409|NCT02998606|"~     To date, few studies have assessed the effect of opioids on esophageal motility, mostly~     assessed the effect of single-dose intravenous morphine on esophageal motility. Recently a~     large retrospective study assessing the effect of opioids on esophageal motility found that~     esophageal motor dysfunction are common in chronic opioid users whether studied on opioids~     and off opioids. In addition, current opioid users also had significantly higher integrated~     relaxation pressure and manometric patterns consistent with type III achalasia. (Ratuapli~     2015) Peripherally acting mu opioid receptor antagonists (PAMORA) appear to be useful to~     reduce the peripheral effects of mu opioid receptor agonists to delay gastrointestinal~     transit without affecting the centrally mediated analgesic effects. MOVANTIK™ (Naloxegol) is~     the first oral peripherally acting mu opioid receptor antagonists for opioid-induced~     constipation. MOVANTIK™ (Naloxegol) has been recently approved for opioid-induced~     constipation. Given orally, 25 mg daily it improves symptoms of constipation. At this dose,~     MOVANTIK™ (Naloxegol) is effective and safe, with a limited side effect profile and is~     associated with preservation of centrally mediated analgesia.~      This study will explore the safety and tolerability of MOVANTIK™ (Naloxegol) in this patient~     population.~      The investigational hypothesis is that MOVANTIK™ (Naloxegol) could improve opioid- induced~     esophageal motility disorders~   "
43411|NCT02998580|"~     This trial will compare conventional sequential bilateral rTMS to a bilateral theta burst~     stimulation protocol. The right and left dorsolateral prefrontal cortices will be the site of~     stimulation in both treatment conditions. The site of stimulation will be targeted using MRI~     co-registration. The study seeks to determine if the bilateral theta burst protocol has~     similar effectiveness to the conventional bilateral rTMS protocol in treating major~     depression.~   "
43412|NCT02998567|"~     HyPeR is a multi-centre Phase 1 Dose Escalation Study of Guadecitabine (SGI-110) a Second~     Generation Hypo-Methylating Agent in Combination with Pembrolizumab (MK3475) in Patients with~     Refractory Solid Tumours. The investigators will be investigating the safety and toxicity of~     the combination.~   "
43413|NCT02998554|"~     The purpose of this study is to determine if an investigational treatment is effective~     compared with placebo in the treatment of adults and children with adenoviral conjunctivitis.~   "
43414|NCT02998541|"~     The purpose of this study is to determine if an investigational treatment is effective~     compared with placebo and PVP-Iodine in the treatment of adults and children with adenoviral~     conjunctivitis.~   "
43415|NCT02998528|"~     The purpose of this study is to determine the safety and effectiveness of nivolumab plus~     ipilimumab or nivolumab plus chemotherapy compared to chemotherapy alone in the treatment of~     Early Stage Non-Small Cell Lung~      This study has multiple primary endpoints.~      The first primary completion date of Pathological Complete Response is anticipated to be~     reached September 2020.~      The completion date for all primary outcome measures is expected May 2023.~   "
43416|NCT02998515|"~     Taken recent literature together, there is a sufficient number of trials investigating the~     effect of different oxygen devices. However, studies comparing oxygen delivery via portable~     oxygen concentrator (POC) and liquid oxygen device (LOD) with appropriate exercise testing~     and sufficient power are missing.~      Given that walking is the most important activity of daily life to preserve the maintenance~     and to participate in social life, we aim to investigate the effects of two different oxygen~     delivery systems during walking in hypoxemic COPD patients (POC vs. LOD).~      The endurance shuttle walk test (ESWT) is well validated for measuring endurance walking~     capacity in COPD patients with good repeatability. The advantage of this test over the 6MWT~     is that the ESWT is performed at 85% of the individual maximum which is close to the~     intensity of typical daily activities. Due to the fact that the ESWT enables us to determine~     the maximum duration of exercise and to compare values at isotime (at the point of time when~     the shortest of the 3 ESWTs ends), we use the ESWT as exercise test in our trial.~   "
43417|NCT02998502|"~     This study will test the efficiency of the Freespira Breathing System in youth.~   "
43418|NCT02998489|"~     This is a randomized controlled trial with infants less than 34 weeks and between 1000 and~     2000 grams at birth, that seeks to establish the safety and effectiveness of fast enteral~     advancement (milk 30-40 cc/kg/d) compared with traditional advancement (milk 20 cc/kg/d)~   "
43419|NCT02998476|"~     The purpose of this study is to assess the safety and efficacy of INCB050465 in subjects with~     relapsed or refractory diffuse large B-cell lymphoma.~   "
43420|NCT02998463|"~     This study evaluates the safety and efficacy of a skin-to-skin facilitating garment used by~     mother-infant dyads. It has three phases including researcher observation, randomised~     controlled trialing and qualitative midwifery staff perspective. The research will determine~     the effect a facilitating garment has in comparison to conventionally facilitated~     skin-to-skin contact, by measuring its effect on the baby's temperature stability,~     breastfeeding status and weight velocity.~   "
43421|NCT02998450|"~     The purpose of this Phase 1a, first in human, randomized, double-blind, placebo-controlled~     study is to evaluate the safety, tolerability, PK and PD profile of the orally administered~     IMR-687 in healthy adult subjects.~   "
43422|NCT02998437|"~     This study evaluate the pharmacokinetic drug interaction in Ilaprazole, Clarithromycin,~     Amoxicillin.~   "
43423|NCT02998424|"~     Resting pupillary diameter was measured at a randomized Effect-site target concentration of~     propofol used as a sole anesthetic.~   "
43424|NCT02998411|"~     In case of sepsis, the therapeutic success is strongly influenced by the choice of~     anti-infectives (AI) in terms of spectrum, dosage and administration schedule. It is~     therefore critical to achieve adequate AI concentration as quickly as possible.~      This protocol aims to define a common framework to studies conducted jointly by the~     Antimicrobial Stewardship Team and the Pharmacology department of Cochin hospital for various~     AI in a range of specific study populations (intensive care unit patients, neutropenic~     patients…).~      These studies will use mathematical modeling methodologies to investigate the~     pharmacokinetics (PK) and pharmacodynamics (PD) of different AI including PK/PD targets. The~     effects of covariates on PK and PD parameters will be investigated to better explain the~     between-subject variability (BSV) and to ultimately suggest individualized dosage regimens.~   "
43425|NCT02998398|"~     The purpose of this study is to evaluate the effectiveness of the switch from the original~     infliximab ( REMICADE®) to its biosimilar (INFLECTRA®) in all the patients at Cochin hospital~     receiving REMICADE® for either a rheumatic, gastro-enterologic or ophthalmic condition~   "
43426|NCT02998385|"~     A phase III, multicenter, randomized, open-label, french study comparing:~        -  Arm A : Radiotherapy alone (66 to 70 Gy; 5 fractions/week; 1fraction/day; 2 Gy/fraction)~        -  Arm B: Radiotherapy (66 to 70 Gy; 5 fractions/week; 1fraction/day; 2 Gy/fraction) +~          concomitant cisplatin 100 mg/m2 IV on day 1 - J22 - 43 (3 cycles)~      Patient can also be treated by protontherapy~   "
43427|NCT02998372|"~     Computational simulation will be performed to represent motion of knees with a dislocating~     kneecap. Common surgical treatment methods will be simulated and anatomical parameters~     commonly associated with the dislocation will be varied in order to characterize the most~     appropriate surgical approach as a function of knee anatomy.~   "
43464|NCT02997891|"~     The purpose of this study is to investigate the effectiveness of a hip arthroplasty for~     chronic pain, caused by a unilateral primary Coxartrhrose, regarding the cognitive~     performance. It is based on the hypothesis that the combination of chronic pain along with~     relative immobilization causes impairment of cognitive performance. The total hip replacement~     reduces pain, increases the mobility level and finally improves the cognitive performance.~   "
43428|NCT02998359|"~     In England each year over 9,000 people fracture their hip. Most of these are elderly females~     with the fracture occurring after a fall. Approximately half of these fractures are~     classified as intracapsular fractures because of their close proximity to the hip joint. The~     majority of these fractures are treated surgically by excising the broken femoral neck and~     removing the femoral head (ball part of the hip joint) and replacing it with an artificial~     hip joint. This hip replacement has traditionally been a hemiarthroplasty or sometimes termed~     a 'half hip replacement' in which only the ball part of the hip joint is replaced.~      An alternative type of hip replacement is the full total hip replacement in which the socket~     part of the joint is also replaced. This is the operation that is used for replacing~     arthritic hips. In recent years there have been a number of randomised trials that have~     compared the outcome for patients with an intracapsular hip fracture treated with either a~     partial hip replacement (hemiarthroplasty) against those treated with a total hip replacement~     (THR). Results to date have suggested slightly better long term functional results for those~     treated with a THR, but it still remains unclear if these benefits are offset by the~     increased surgical complexity of the procedure and the extra cost involved for a THR.~      At present the numbers of studies on this topic are too few with limited patient numbers to~     make any definite conclusions. This study aims to add to the research studies by comparing~     the two surgical procedures, to enable orthopaedic surgeons to determine the optimum surgical~     treatment for this common and disabling condition.~   "
43429|NCT02998346|"~     The purpose of this observational study is to measure the number of calories delivered from~     fluids used in continuous renal replacement therapy (CRRT). We are doing this research study~     because the fluids used in this treatment may deliver an important number of calories. In the~     future this could help better estimate how much nutrition patients in the Critical Care Unit~     should get every day from other sources like tube feeding or nutrition through a person's~     veins.~   "
43430|NCT02998333|"~     Rationale: Lateral ankle ligament injuries may be a result of ankle sprains. In 10-30% of~     patients with lateral ankle ligament injuries, chronic lateral ankle instability may be~     present. If conservative treatment fails, instability is treated surgically. Anatomic repair~     (also known as the Bröstrom procedure) is the current golden standard for surgical treatment~     of chronic ankle instability. The Bröstrom started out as an open technique and is now also~     performed arthroscopically. Both approaches are considered standard care and provide good~     results. Which approach is best, has not yet been researched. In this study it is~     hypothesized arthroscopic repair provides better functional outcome compared to open repair~     during short term follow-up.~      Objective: The main objective of this study is to compare the functional outcome after~     arthroscopic and open anatomic repair in patients with chronic lateral ankle instability, and~     secondly to assess ankle stability and ankle Range of Motion (ROM) after arthroscopic and~     open ligament repair.~      Study design: A Non-Blinded Prospective Randomized Controlled Trial Study population: All~     patients willing to participate, from an age of 18 years old, with persisting ankle~     instability for at least 6 months, eligible for anatomic repair.~      Intervention: Both groups of patients are surgically treated with anatomic repair of the~     anterior talofibular ligament (ATFL). One group is treated arthroscopically and the other by~     the open approach.~      Main study parameters/endpoints: The primary outcome measure is functional outcome 6 months~     after surgery measured using the Foot and Ankle Outcome Score. The main study parameter is a~     difference of ≥10 2 points per FAOS subscale between both treatment groups (Minimal Important~     Change = 10 points; 2 per subscale).~   "
43431|NCT02998320|"~     This study measures the proportion of enrolled patients taking the uninterrupted HIV~     post-exposure prophylaxis Genvoya for four weeks~   "
43432|NCT02998307|"~     Objectives: The primary objective is to determine the least frequent CPR training interval~     associated with continued performance of guideline-compliant CPR. The secondary objective is~     to determine whether certain physical characteristics, such as age, gender, exercise~     tolerance, height, and weight may be able to identify HCPs at high risk of being unable to~     perform high-quality CPR.~      Design: Randomized trial to compare the effect of different training frequencies on long-term~     CPR performance.~      Participants and setting: Nurses in all adult departments at Health Sciences North. Subjects~     will be randomly assigned to a group that undertakes short CPR assessment and training~     sessions either 1) every month, 2) every 3 months, 3) every 6 months, or 4) every 12 months~     (control group) over the course of a twelve-month period.~      Analysis: The proportion of nurses in each group that is able to perform excellent CPR at~     the twelve-month time point will be determined. Excellent CPR is defined as a two-minute CPR~     session where 90% of compressions are performed with correct depth (50-60 mm), 90% with~     correct rate (100-120 /min), and 90% with full chest recoil. A subgroup analysis will also be~     performed where the demographic data of individuals who are unable to perform excellent CPR~     at the twelve-month time point regardless of intervention group are compared against those~     who are successful.~      Conclusion: The results of our study will help determine the longest CPR training interval~     associated with maintenance of high-quality CPR skills to minimize training sessions required~     and decrease associated costs. The results will also generate hypotheses for future study~     about optimizing role assignments and team performance in resuscitation.~   "
43433|NCT02998294|"~     The purpose of this study was to determine the accuracy of one-time respiratory volume~     measured by RVM(Respiratory Volume Monitor) compared to the one-time respiratory volume~     measured by mechanical ventilation in post-operative ICU patients.~   "
43434|NCT02998281|"~     Even if cerebral palsy not directly effect respiratory system, impairment of nervous and~     muscle systems, because of the brain damage, may cause respiratory functions impairment. In~     literature, it has been showed that children with cerebral palsy have decreased respiratory~     muscle strength and associated with trunk control, quality of life and respiratory functions.~     But, there is no study in literature that aims to increase respiratory muscle strength in~     these children. Hence, the aim of this study is to investigate effects of inspiratory muscle~     training on respiratory functions, trunk control, activities of daily living, functional~     exercise capacity and quality of life in children with cerebral palsy.~   "
43435|NCT02998268|"~     This is a randomized, multicenter phase II study of pembrolizumab in combination with~     chemotherapy and chemoradiation in locally advanced esophageal adenocarcinoma to examine the~     safety and efficacy of the combination of pembrolizumab with chemotherapy and chemoradiation~     in locally advanced esophageal adenocarcinoma as assessed by 1 year disease free survival~     rate.~   "
43436|NCT02998255|"~     Adequate quality of bowel preparation(BP) is important for colonoscopy. Several guidelines~     recommend that split-dose of 4L PEG should be used as a standard regime for BP. However, the~     high-volume PEG still results in lower compliance to the regime and increased cost.~      Some high risk factors for inadequate BP have been identified, including old age,~     constipation, diabetes, the use of narcotics and prior history of inadequate BP. For~     average-risk patients without the high risk factors, the procedure of BP could be easier. In~     the previous study, with the use of single dose of 2L PEG, more than 90% of average-risk~     patients achieved adequate BP. Here investigators hypothesized that compared with the~     standard split dose of 4L PEG, single dose of 2L PEG may be not inferior in BP quality while~     may be accompanied with better tolerability.~   "
43437|NCT02998242|"~     To study safety and efficacy of apatinib in combination of radiotherapy in patients with~     symptomatic bony disease prostate cancer (SBPC), based on the potential synergistic antitumor~     activity between Apatinib and Stereotactic Body Radiation Therapy (SBRT).~   "
43438|NCT02998229|"~     The purpose of this study is to assess the safety and effectiveness of the Artisse™~     Intrasaccular Device in the treatment of bifurcating saccular intracranial aneurysms.~   "
43439|NCT02998216|"~     This study aims to the assessment of pelvic floor symptoms and patients´ satisfaction after~     bilateral sacrospinous fixation for the primary treatment of pelvic organ prolapse stage IV.~   "
43440|NCT02998203|"~     The study aims to evaluate the hypothesized benefits of a systematic organic diet for~     children, over those of a conventional diet. The specific objectives of this study are to: i)~     Demonstrate the decreased body burden of pesticides for those children consuming an organic~     diet, and ii) Evaluate the effects in specific biomarkers of inflammation and oxidative~     stress in children systematically consuming an organic diet.~   "
43441|NCT02998190|"~     The purpose of this study is to determine the safety profile of single and multiple doses of~     EB8018 in healthy male subjects, to determine the pharmacokinetic profile of single and~     multiple doses of EB8018 in healthy male subjects and to assess preliminary effects of EB8018~     on the healthy male gut microbiome.~   "
43442|NCT02998177|"~     The objective of this study is to determine the association between gut microbiome diversity~     and the characteristics of rebound pain at offset of peripheral nerve block in patients who~     have undergone upper limb surgery. Other purposes of this study are to determine associations~     between gut microbiome constitution and persistent post-surgical pain; and describing rebound~     pain by quantifying its clinical, psychological and neurophysiological characteristics in~     this patient cohort.~   "
43443|NCT02998164|"~     This study evaluates the efficacy of using augmentative and alternative communication (AAC)~     technology for enhancing language development in children who are deaf or hard of hearing.~     Half of the participants will receive AAC technology with their speech and language therapy~     and half will continue with their usual care models.~   "
43444|NCT02998151|"~     The aim of this study is to utilize neurophysiologic assessments, behavioral measures and~     clinical measures to assess how much deficits associated with Fragile X Syndrome from~     pre-dose to post-dose Acamprosate, lovastatin, minocycline and placebo.~   "
43445|NCT02998138|"~     This will be an open label, prospective study to determine the association between specific~     genotypes, epigenetics and behavioral factors, with the phenotypes, defined by pain~     perception, postoperative pain, analgesic and side effect responses to perioperative opioids,~     chronic postoperative pain and gene expression in adolescents following major spine surgery.~   "
43446|NCT02998125|"~     The intention is to explore whether there are factors, which can help us to understand why~     some patient outcomes, following total knee arthroplasty are not successful and identify~     prediction factors for progression. Assessment of outcomes pre- and post-surgery with~     objective tools is a way to explore prediction tools for good/poor progression and improve~     patient selection and timing for surgery.~      The first aim of this project is determine the psychometric properties of the Arabic Version~     of Oxford Knee Score, including internal consistency, reliability and validity before and~     post-total knee arthroplasty in both males and females in a Middle East population. The~     second aim is to assess the reliability of the Star Excursion Balance Test for measuring the~     dynamic balance. The final aim is explore outcomes post-total knee arthroplasty among Middle~     East patients using the Arabic Version of Oxford Knee Score, physical activity measures and~     performance-based measurements such as: 30 s chair-stand test, stair-climb test, timed~     up-and-go test and a 6 m walk test while adhering to Osteoarthritis Research Society~     International recommendations.~   "
43447|NCT02998112|"~     To indicate the efficacy of Fecal microbiota transplantation (FMT) for the treatment of~     Ulcerative colitis (UC), The investigators design a multicenter, randomized controlled trial~     to perform FMT through colonic transendoscopic enteral tubing (TET) way, and evaluate the~     efficacy and safety of FMT for patients with moderate or severe UC.~   "
43448|NCT02998099|"~     The purpose of this study is to evaluate the effect of age on PK, safety and tolerability of~     IV rivipansel.~   "
43449|NCT02998086|"~     Parenting a child with cancer is highly stressful. The investigators have designed a~     promising parent-centered intervention to bolster parent resilience and reduce stress and~     distress. This study will test 2 formats of the intervention (individual or group-based) and~     compare them to usual care.~   "
43450|NCT02998073|"~     This research focuses on justice-involved youth with conduct disorder (CD) and a history of~     violence. CD is a youth-limited neurodevelopmental disorder that is commonly associated with~     criminality. Although psychosocial interventions that address impulsivity and self-control~     have been shown to be effective at helping promote prosocial behavior in patients with CD,~     the biological changes that occur as a result of treatment are not well understood. This~     study will explore changes in cortisol (a stress hormone) and the brain function of the~     anterior cingulate cortex (ACC) in response to a common psychosocial intervention (Stop, Now~     and Plan Youth Justice Model). This study will contribute to our understanding of biological~     mechanisms involved in therapeutic gains among youth offenders and thereby inform further~     development of treatment programs for justice-involved youth.~   "
43483|NCT02997644|"~     The purpose of this study is to evaluate the use of post-operative opioid use after two~     different educational interventions. The investigators will compare changes in pain,~     disability and sleep between groups 6 months after elective lower extremity surgery.~   "
43451|NCT02998060|"~     Computer-based navigation systems were first introduced to spine surgery in 1995 and while~     they have been long established as standards in certain cranial procedures, they have not~     been similarly adopted in spine surgery. Designed to overcome some of the limitations of~     navigation-based technologies, robot-guided surgical systems have become commercially~     available to surgeons worldwide.These systems are rapidly challenging the gold standards.~      The aim is to conduct a prospective randomized controlled trial. The randomized variable will~     be the screw placement technique used. One arm will be treated with lumbar fusion using~     robotic guidance (RG), one arm will receive the same procedure but with a free hand technique~     (FH) and the third arm will use navigation (NV) (CT or Fluoroscopy-assisted). Intraoperative~     screw revisions and revision surgery for screw malposition as well as clinical~     patient-reported outcomes to identify any such differences between these methods of screw~     insertion will be assessed.~   "
43452|NCT02998047|"~     1. Establish the MTD of fractionated doses of Lintuzumab-Ac225 as monotherapy~        2. Establish overall response rate (ORR) where ORR = CR + sCR+ VGPR+PR)~        3. Confirm the safety profile of the treatment regimen~        4. Determine changes in plasmocyte, T-cell and MDSC cell populations~        5. Estimate progression-free survival (PFS) and overall survival~   "
43453|NCT02998034|"~     In England each year over 9,000 people fracture their hip. Most of these are elderly females~     with the fracture occurring after a fall. Approximately half of these fractures are~     classified as intracapsular fractures because of their close proximity to the hip joint. The~     majority of these fractures are treated surgically by excising the broken femoral neck and~     removing the femoral head (ball part of the hip joint) and replacing it with an artificial~     hip joint. This hip replacement has traditionally been a hemiarthroplasty or sometimes termed~     a 'half hip replacement' in which only the ball part of the hip joint is replaced.~      There are a number of different designs of hemiarthroplasty that may be used. Some of the~     implants are fixed in place with bone cement whilst the rest are inserted as a press fit~     without the bone cement. The early designs of implant were all press fit but these designs~     have now been shown to be inferior to those implants that are fixed in place with bone~     cement.~      There are however a number of newer designs of implant that are coated with a substance~     (hydroxyapatite) that encourage the bone to grow onto the implant to fix it into place. To~     date these implants have only been compared to the cement fit implants in only one previous~     study. This study found no notable difference between the two types of hemiarthroplasty. This~     study aims to add to the research studies by comparing standard cement fit implant with a~     hydroxyapatite coated press fit implant to assist in determining the optimum surgical~     treatment for this common and disabling condition.~      Both implants to be used in this study are still being used extensively within the United~     Kingdom and worldwide to treat this fracture. The study is therefore using two different~     implants within their recommended area of use, but in which there is uncertainty as to which~     is the best implant.~   "
43454|NCT02998021|"~     The primary purpose of this study is to explore the benefits of vibration dumbbell resistance~     training over standard dumbbell resistance training for improving upper limb strength,~     function and pain among manual wheelchair users with paraplegia.~   "
43455|NCT02998008|"~     It is known from research that long-term exercise exposure in type 2 diabetes had positive~     effects. However, the effect of acute exercise in a patient group with already reduced~     cardiac function is not known.~      In this study, the impact of acute exhaustive high intensity interval training on cardiac~     function will be investigated in type 2 diabetes patients.~      One single session of exhaustive high intensity interval exercise training is expected to~     lead to a greater cardiac stress in diabetics than in non-diabetics, and in addition the~     right ventricle of the heart is expected to be more affected than the left ventricle.~   "
43456|NCT02997995|"~     This is an open-label, multicentric, international, phase II trial testing aromatase~     inhibitors in combination with durvalumab in patients with CD8+ T cell infiltration (>10%~     CD8+ T cells in the tumor). The trial includes two sequences: The first part of the treatment~     will consist in 4-6 weeks treatment with immune-attractants; in the second part, CD8+~     patients will receive 6 months of durvalumab combined with exemestane.~   "
43457|NCT02997982|"~     This study investigates the effects of Valaciclovir treatment to individuals with Alzheimer's~     disease or Mild Cognitive Impairment of Alzheimer's Disease Type. It is an open pilot trial~     where 36 participants will receive 4 weeks of Valaciclovir treatment. Participants will be~     investigated using different measures before and after the treatment period.~   "
43458|NCT02997969|"~     The purpose of this study is to evaluate the safety and immune response to an HIV clade C DNA~     vaccine and to an MF59-adjuvanted clade C Env protein in healthy, HIV-uninfected adults.~   "
43459|NCT02997956|"~     This is a phase IB study design planned to identify the MTD (Maximum Tolerated Dose) of~     Tocilizumab in HCC (Hepatocellular Carcinoma) patients followed by a phase II design~     whereupon the primary objective will be median progression free survival (PFS).~   "
43460|NCT02997943|"~     The overall objective of this study is to use an innovative experimental approach, the SMART~     (Sequential Multiple Assignment Randomized Trial), to determine the best way to sequence the~     delivery of mHealth tools and traditional treatment components in a stepped program of~     obesity treatments. The SMART approach is a highly efficient strategy for identifying and~     constructing efficacious adaptive interventions: it accommodates sequential decision-making~     based on the participant's response to early weight loss treatment components. The proposed~     treatment package begins with the least expensive components, and for participants identified~     as treatment non-responders, provides sequential step-up of additional treatment components.~     By sequentially delivering treatment components based on participant response, SMART permits~     achievement of the target outcome, weight loss, with least resource consumption and~     participant burden.~   "
43461|NCT02997930|"~     The long-term goal of this study is to evaluate cognitive function preoperatively and develop~     techniques of intervention in the perioperative period which would optimize brain function~     and functional recovery following surgery.~   "
43462|NCT02997917|"~     The effect of education on the responses to a probe meal (250 mL vegetable soup cooked at low~     temperature and 25 g bread) will be studied in a parallel design. The effects of education~     will be tested in two different groups in random order: real versus sham education. In each~     group the responses to a probe meal will be tested on 2 different days before and after the~     intervention. Participants will be instructed to eat a standard dinner the day before, to~     consume a standard breakfast at home after overnight fast, and to report to the laboratory,~     where the probe meal will be administered 3 h after breakfast. Studies will be conducted in a~     quiet, isolated room with participants sitting on a chair. Perception will be measured at 5~     min intervals 10 min before and 20 min after ingestion and at 10 min intervals up to 60 min~     after the probe meal.~   "
43463|NCT02997904|"~     A one day study to demonstrate that Resultz Lice and Egg Elimination Kit is statistically~     superior to a sham control with one hour of combing.~   "
43465|NCT02997878|"~     MERLIN is an adaptive, single arm, multi-centre, phase IIa multi-disease clinical trial. It~     is designed to:~      i) Determine dose safety of ORBCEL-C (selected Mesenchymal stromal cells derived from human~     umbilical cord) ii) Evaluate treatment activity through assessment of biomarkers~      This trial has two main stages:~        -  Stage 1 will determine the maximum tolerated dose that can be administered by observing~          for occurrence of dose limiting toxicity (DLT).~        -  Stage 2 will use the maximum tolerated dose found in stage 1 to and further determine~          safety and activity outcomes of ORBCEL-C.~      Upon completion of this trial we hope to be able to justify and conduct separate, larger~     scale trials using ORBCEL-C.~   "
43466|NCT02997865|"~     This study evaluates stepped care for depression in patients with heart failure (HF). The~     stepped care intervention includes cognitive behavior therapy (CBT), plus antidepressant~     medication when indicated. Half of the participants will receive stepped care and half will~     receive usual care for depression; all participants will receive heart failure self-care~     education and support. The primary aims are to determine whether stepped care is superior to~     usual care for depression, and whether treating depression improves heart failure self-care~     outcomes.~   "
43467|NCT02997852|"~     The purpose of this study is to assess the preliminary efficacy of a 10-minute therapy dog~     visitation (TDV) in reducing biobehavioral stress responses.~   "
43468|NCT02997839|"~     The role of sleep in patients admitted to the intensive care unit is an emerging field of~     research. There have been studies that show patients in the ICU have poor sleep including~     sleep fragmentation, multiple arousals, decreased stage 3 sleep and reduced REM sleep (1, 2,~     3). Causes of poor sleep in the ICU include severity of illness, abnormal light exposure, and~     frequent arousals for medical care. Not only does poor sleep contribute to reduced cognitive~     function and delirium, but there are also implications for the immune system function and~     wound healing (4). Polysomnography is regarded as the gold standard for sleep studies,~     however it has limited utility in the ICU population (5) and alternative methods of sleep~     analysis need to be investigated to better understand the underlying physiologic mechanisms~     and subsequent cognitive effects.~   "
43469|NCT02997826|"~     From birth to 5 months, milk is the essential and unique food of the newborn. The French~     National Nutrition Program (PNNS) recommends exclusive breastfeeding up to 6 months and at~     least 4 months for a healthy benefit. However, only 36% of infants 0-6 months of age are~     exclusively breastfed worldwide. Some mothers choose to give infant formula to their baby in~     the first few months of life. This decision may be a personal choice or be imposed by~     pathophysiological situations.~      The nutritional requirements of the infant are specific, which implies adequate nutrition.~     Infant formulas and follow-up formulas are therefore complex products, specially developed~     for a group of vulnerable consumers. In fact, the compositional and information requirements~     for infant formula are highly regulated.~      Even clinical studies are not required to market an infant formula, it is important to obtain~     objective date on infant growth. Therefore, this study proposes to evaluate the effect of the~     consumption of an infant formula on the growth of infants from 0 to 6 months in comparison~     with the growth curves of the World Health Organization (WHO).~   "
43470|NCT02997813|"~     This is a retrospective observational cohort database analysis. The study will review~     retrospectively the records of patients undergoing a first peripheral blood stem cell~     mobilization for multiple myeloma in the databases from approximately 15 hospitals which are~     part of the IFM collaborative group. Patient records will be divided into two groups of 50~     patients minimum, maximum 100 patients or up to the number of patient records that could be~     extracted. The first group of patients will have received plerixafor plus G-CSF without the~     administration of chemotherapy as a mobilization strategy and a second group of patients will~     have received cyclophosphamide plus G-CSF as a mobilization strategy.~      All consecutive patients with complete set of data (and who underwent apheresis) treated~     between 2009 and 2013 with G-CSF and plerixafor and all consecutive patients with complete~     data (and who underwent apheresis) treated between 2009 and 2013 with G-CSF and~     cyclophosphamide will be included.~      All data that will be analyzed will be extracted from the selected IFM institutions which are~     located in France.~   "
43471|NCT02997800|"~     Patients coming for surgery often receive opioid medications, like fentanyl, to treat pain.~     Opioids however have many unpleasant side effects including nausea and vomiting, itching,~     sedation, and decreased breathing. During laparoscopic surgery increases in heart and blood~     pressure are often attributed to pain. It has been shown that by treating these changes with~     medications such as esmolol, instead of opioids, side effects and time to discharge from~     hospital can be reduced. Labetalol is a drug that is similar to esmolol but may have~     advantages over it. It is more effective at controlling both heart rate and blood pressure~     and it is easier and less costly to use. This study is investigating labetalol in patients~     having laparoscopic gallbladder surgery and comparing it to esmolol and fentanyl. Patients~     will be treated with one of these drugs during surgery to control heart rate and blood~     pressure and the effects on time to discharge, pain scores, frequency of side effects, and~     narcotic requirements will be observed in the recovery room. It is thought that labetalol~     will be shown to be as effective as esmolol and that both drugs that minimize fentanyl will~     show reduced time to discharge, fewer side effects, and effective treatment of heart rate and~     blood pressure.~   "
43472|NCT02997787|"~     Both pelvic masses and preoperative diagnosis of them have still continued as an important~     investigation subject. It is important to discriminate the diagnoses of leiomyoma and~     adenomyosis before operation especially among infertile patients. Neoplasms can alter~     systemic or local immune response in their originating area.Neutrophil to lymphocyte ratio~     (NLR) and platelet to lymphocyte ratio (PLR) can be readily determined by using of complete~     blood counter test (CBC). A high NLR has been shown in systemic inflammation, some~     gynecologic and gastrointestinal cancers and some cardiovascular diseases.~      The investigators aim to investigate using new inflammation markers, NLR and PLR, whether~     they are useful to discriminate between adenomyosis and leiomyoma. As far as is known, there~     have been no previous reports about the association among NLR, PLR, adenomyosis and~     leiomyoma.~   "
43705|NCT02994732|"~     The primary objective of this study is to characterize the metabolic disposition,~     pharmacokinetics (PK), and routes of elimination of [14C]‑labeled BVD‑523 after~     administration of a single, oral dose to healthy male subjects.~      The secondary objective of this study is to evaluate the safety and tolerability of a single~     oral dose of [14C]‑labeled BVD‑523 in healthy male subjects.~   "
43473|NCT02997774|"~     Having hemodialysis affects the blood supply to various organs in the body including the~     heart and the brain. With time, these effects build up and can affect the way these organs~     function. The investigators have previously shown that the liver (a key organ which works to~     help clean the blood, make proteins and turn all your food into energy) is also affected. One~     of the ways to help protect organs from injury due to dialysis has been cooling during~     dialysis. The investigators want to examine whether cooling during dialysis protects the~     blood supply to the liver. CT imaging will be used to measure this blood supply during~     hemodialysis with standard and cooler settings.~   "
43474|NCT02997761|"~     This phase II trial studies how well ibrutinib and blinatumomab work in treating patients~     with B acute lymphoblastic leukemia that has come back or is not responding to treatment.~     Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell~     growth. Monoclonal antibodies, such as blinatumomab, may interfere with the ability of cancer~     cells to grow and spread. Giving ibrutinib and blinatumomab may work better in treating~     patients with relapsed or refractory B acute lymphoblastic leukemia.~   "
43475|NCT02997748|"~     Acute kidney injury (AKI) is a well-recognized complication after cardiac surgery with~     cardiopulmonary bypass (CPB). The aim of this study is to reduce the incidence of AKI by~     implementing remote ischemic preconditioning and to evaluate the dose-response relationship~     using the biomarkers urinary [TIMP-2] *[IGFBP7] in high risk patients undergoing cardiac~     surgery.~   "
43476|NCT02997735|"~     Secondhand smoke (SHS) exposure is a significant public health problem in that it both harms~     children and is widely prevalent, affecting more than 40% of US children. Tobacco cessation~     quitlines are effective in helping smokers quit, but few smokers make use of their services.~     Electronic health record-based systems that automate referral of interested parents to~     quitlines through pediatric settings may increase the proportion of smokers who successfully~     enroll in treatment.~   "
43477|NCT02997722|"~     Patients admitted to the University of Mississippi's inpatient psychiatry unit for suicidal~     ideations will be given the opportunity to participate in the study. Within 24 hours of~     arriving to the inpatient psychiatric floor, patients who choose to participate will be~     randomized to receive either a placebo saline infusion or a ketamine infusion of 0.5 mg/kg~     over the course of 45 minutes. Infusions will take place in the University of Mississippi~     Medical Center's Post Anesthesia Care Unit and/or Short Stay Procedure Area. Patients will be~     monitored for 30 minutes after the completion of their infusion. The inpatient psychiatry~     team will assess all patients' suicidal ideations daily while they are inpatient at UMMC and~     the primary outcome will be the patient's inpatient hospital course length.~   "
43478|NCT02997709|"~     Prostate cancer is the most common malignancy in men and nearly 30,000 deaths occur from the~     disease each year. Not only is there significant mortality, there is also considerable~     morbidity from primary and salvage therapies. Understanding which patients require~     intensified treatment, as well as those who might not require treatment, would improve~     outcomes on multiple levels. The cohort to be investigated will be comprised of men with~     intermediate to high risk prostate cancer who are candidates for radiotherapy (RT). The~     overarching objective of the CoMBINe trial is to identify pretreatment and post-treatment~     prognostic and predictive factors derived from quantitative imaging prostate features, tumor~     tissue gene expression signatures, and circulating tumor cells (CTCs). The CoMBINe trial is a~     sister trial to another study, termed BLaStM (IRB# 20140627), in men who are candidates for~     radiotherapy. CoMBINe also allows for men with oligometastasis who are sometimes treated with~     RT to the prostate and limited metastatic sites.~   "
43479|NCT02997696|"~     The purpose of this phase 2, randomised, double-blind, placebo controlled, parallel group,~     multicentre study is to investigate the efficacy, safety, tolerability and pharmacokinetics~     of a compound ONO-4474 in patients with moderate to severe pain due to osteoarthritis of the~     knee following 4 weeks of oral administration of ONO-4474.~   "
43480|NCT02997683|"~     In order to evaluate Long term effects of whole Body Vibration (wbv) in patients with PAH and~     CTEPH patients will get a training device to use at home for 3 months. Patients in the~     Intervention group will be introduced in the training program on the wbv-device in the study~     center 3-4 times and baseline Parameters will be collected before start of the home based~     training. Patients randomized into the placebo arm be introduced into the training program~     according to the interventional arm but not perfoming the exercises on the wbv-device but on~     the floor.~   "
43481|NCT02997670|"~     Cardiac resynchronisation therapy (CRT) improves outcomes and symptoms in selected patients~     with heart failure. However, around one third of suitable patients do not demonstrate benefit~     following device implantation when assessed by echocardiography (heart scanning). This group~     has poorer outcomes.~      Response rate can be enhanced by altering timing delays between the pacing leads, but some~     patients still fail to improve.~      Quadripolar left ventricular leads are now widely used in CRT. The lead's four poles increase~     the number of conformations available to the programmer, allowing multiple vectors to be~     programmed simultaneously or sequentially. This allows programming to avoid, for example, a~     patch of scar and find an area that will respond better to pacing. This technique is known as~     multi-site pacing. CRT is often implanted along with a defibrillator lead in the right~     ventricle, known as CRT-D. The defibrillator lead offers further combinations for pacing.~      Goal of Research To evaluate an algorithm for assessing different multi-site pacing~     combinations in optimisation of CRT~      Outline The investigators will recruit 24 consecutive patients undergoing CRT-D implantation~     for conventional indications at our hospital. At baseline, patients will undergo~     echocardiography, exercise testing and assessments of functional ability and quality of life.~     The device will be implanted as standard. Optimisation will be performed with an algorithm~     using different vector combinations and assessing the heart's efficiency through~     echocardiography and invasive pressure monitoring. The pacemaker will be programmed with~     standard settings. After twelve weeks, the baseline investigations and optimisation algorithm~     will be repeated and the device programmed according to the maximum efficiency. After a~     further 12 weeks, the same parameters will be measured to look for improved response to CRT.~      Potential Benefit To increase the response rate to cardiac resynchronisation therapy and~     improve reliability of the technique~   "
43482|NCT02997657|"~     Positive Psychotherapy for Smoking Cessation (PPT-S) addresses an array of risk factors for~     poor smoking outcomes (low positive affect, depressive symptoms, and cynical cognitions),~     while also providing skills that may buffer against stress and negative affect. The overall~     objective of this project is to conduct a randomized controlled trial to test the efficacy of~     PPT-S, enhanced with text messaging, compared to a time-matched behavioral smoking cessation~     treatment. Participants in both treatment conditions will receive nicotine replacement~     therapy and a validated text-messaging intervention for smoking cessation that monitors~     progress in quitting smoking and extends smoking counseling outside of the individual~     face-to-face context.~   "
43484|NCT02997631|"~     Intravenous (IV) insertion is one of the most common procedures for children seeking medical~     treatment in the Emergency Department (ED). This procedure is often painful and distressing~     for children and families. This can result in an uncooperative child, a need for multiple~     cannulation attempts, needle phobia, and dissatisfaction with care for family and healthcare~     workers. Non-pharmacological treatments are emerging as a newly favoured adjunct to~     pharmacotherapy, such as distraction therapy.~      Distraction therapy involves engaging children in cognitive tasks in order to divert~     attention from painful stimuli and reduce pain and distress. Currently, distraction therapy~     is not utilized as a standard of care in the ED. Given children's enthusiasm for~     technological devices, we propose that the use of a technologically enhanced device may be a~     more effective distractor and may have a greater impact on pain reduction outcomes of patient~     importance. The primary objective of this study is to compare the reduction of pain and~     distress with the use of distraction (via the MEDi robot) versus current standard care in~     children aged 6 to 11 years who are undergoing IV placement.~   "
43485|NCT02997618|"~     Rupture of abdominal aortic aneurysms(AAA) causes 12,000 deaths/year in the UK.1 Elective~     repair to prevent this carries a perioperative mortality of 4.5% for open surgery and 1% for~     endovascular repair. This risk is associated with poor cardiorespiratory fitness which can be~     measured using Cardiopulmonary Exercise Testing(CPET) with the CPET variables, peak oxygen~     uptake(peakVO2)<15ml/kg/min and anaerobic threshold(AT)<10.2ml/kg/min identifying patients at~     increased risk of early death after AAA repair.3 These variables can therefore be used as~     surrogate markers for cardiovascular fitness and risk of mortality and morbidity in AAA~     surgery; optimising these markers should improve fitness and decrease this risk. The optimal~     duration and type of exercise training for improving peak VO2 and AT in AAA patients is not~     known. AAA patients are unique as they are motivated to reduce the risk of impending surgery~     but are afforded the time to improve their fitness as repair may not be needed for months or~     even years.~      The investigators propose a pilot randomised controlled trial to explore the effectiveness of~     a 20-week community (either home or gym-based) exercise programme to achieve sustained~     improvements in peak VO2 and AT, as measured by CPET, in AAA patients. Changes in QoL,~     habitual activity levels and cardiovascular risk will also be assessed. The results will~     inform a definitive multicentre clinical trial on exercise to improve outcomes in elderly~     patients with cardiovascular disease and AAA.~   "
43486|NCT02997605|"~     The purpose of this study is to compare the proportion of patients who could withdraw from~     prednisone and hydrocortisone one year after a progressive decrease of GC (GC tapering) or a~     hydrocortisone replacement therapy in rheumatoid arthritis in remission or low disease~     activity.~   "
43487|NCT02997592|"~     Evaluation of the SpinCare™ System in the Treatment of Partial Thickness Burns. A~     prospective, single arm, safety and efficacy, open labeled multi-center study~   "
43488|NCT02997579|"~     Patellar crepitus is a complication of total knee arthroplasty (TKA).The development of~     patellar crepitus after TKA are related to many factors such as femoral component design,~     surgical errors, and postoperative patellar baja. However, it is unclear whether patella~     resurfacing or patella non-resurfacing are associate with patellar crepitus. The primary~     objective of this study are to compare the prevalence of patellar crepitus and the mean value~     of vibroacoustic signal between patellar-resurfacing and patellar non-resurfacing in TKA. The~     secondary objective is to study the association between patellar crepitus and vibroacoustic~     signal.~   "
43489|NCT02997566|"~     Background: the autism spectrum disorders (ASD) can be related with abnormalities in cortical~     structures and cause behavior imbalances. In addition, as soon as the diagnosis is done, the~     better will be the prognosis. In this context, heart rate variability (HRV) stands out, which~     is a non-invasive tool representing autonomic modulation, with potential prognostic value.~     The literature showed there are no changes in HRV at rest using linear methods of analysis,~     but changes can be identified during tasks. Nonlinear methods of HRV are more sensitive and~     provide additional information to the linear. Objective: to analyze autonomic modulation~     using nonlinear and linear indexes of HRV in children with ASD at rest and during tasks in~     comparison to typical children. In addition, to correlate HRV analysis between them, also~     between behavior and severity of the disease. Methods: this study involves both typical~     children and children with ASD. Autonomic modulation will be performed using nonlinear~     indices (extracted from Poincaré plot, detrended fluctuation of tendency analysis and~     recurrence plot) and linear indices of HRV in the time (RMSSD e SDNN) and frequency domain~     (LF, HF, VLF). The tasks consist in games to identify and recognize faces and facial~     expressions. Behavior and severity of the disease will be evaluated using the Autism Behavior~     Checklist and the Childhood Autism Rating Scale respectively. Statistical Analysis: to~     identify differences between moments and protocols two-way analysis of variance will be used~     along with the Bonferroni post-test or Dunn post-test according to the data distribution.~     Statistical significance will be set at 5%.~   "
43490|NCT02997553|"~     This is a single-center prospective clinical trial to evaluate non-inferiority of indocyanine~     green guided sentinel lymph node biopsy compared with the gold standard Technecium99 guided~     sentinel lymph node biopsy in patients with cancers and subjected to surgery.~      The diagnostic performance and the tolerance of indocyanine green (ICG) to the radio-isotope~     (Techniciun99) in the detection of sentinel lymph nodes will be assess using an Optonuclear~     probe (EURORAD S.A.).~   "
43491|NCT02997540|"~     The purpose of this study is to demonstrate that BVN G-1000 can precisely and consistently~     measure the position of female breast lesions regardless of patient rotation and probe angle~     during ultrasound examination.~   "
43492|NCT02997527|"~     This study is being done to determine if people with and without GERD or trouble swallowing~     have increased esophageal mucosa impedance (food getting into the esophageal tissue).~   "
43511|NCT02997280|"~     Steroid-refractory acute GVHD (srGVHD) is one of the causes of mortality after allogeneic~     stem cell transplantation, while steroid-refractory chronic GVHD significantly increases~     morbidity, aggravates quality of life and may also impact survival. Currently there is no~     standard treatment of srGVHD. One of the most promising agents is Janus kinase (JAK)~     inhibitor ruxolitinib, which in the retrospective study demonstrated excellent response rate~     and survival of patients with either acute or chronic srGVHD. This study prospectively~     evaluates the efficacy of ruxolitinib in srGVHD patients.~   "
43493|NCT02997514|"~     The purpose of this study is to implement Solution Focused Coaching in pediatric~     rehabilitation (SFC-peds) within the multidisciplinary neuromuscular clinic at Holland~     Bloorview Kids Rehabilitation Hospital and evaluate its effect on children's ability to set~     and attain personally meaningful goals. A secondary goal is to determine the impact of~     SFC-peds on self-determination in children with neuromuscular conditions. This study aims to~     compare two methods of SCF-peds delivery, a single coaching session vs. intensive coaching (5~     sessions) on goal attainment. This study will also help researchers and clinicians understand~     the types of goals that are set by children with neuromuscular conditions. Lastly, this study~     is going to explore with the participants their perception of the feasibility of using this~     methodology within a clinical context.~   "
43494|NCT02997501|"~     The aim of this study is to evaluate concordance of T790M mutation plasma testing between the~     Cobas test and each of other platforms: Super-ARMS, digital PCR or NGS. And to assess the~     efficacy of AZD9291 monotherapy by assessment of PFS in adult patients with advanced or~     metastatic NSCLC, who have received prior EGFR-tyrosine kinase inhibitor (TKI) therapy and~     are T790M mutation positive detected by any one of the four plasma testing platforms:~     Cobas/Super-ARMS/ digital PCR/NGS.~   "
43495|NCT02997488|"~     Recently many kinds of indirect videolaryngoscopes were developed. These videolaryngoscopes~     provide easier intubation, help intubation difficulty, are used good tool for education.~     McGrath Videolaryngoscope and Pentax AirwayScope are kinds of these videolaryngoscopes.~      The purpose of this study is to compare of routine endotracheal intubation with McGrath~     Videolaryngoscope and Pentax AirwayScope by means of providing better laryngeal view, easier~     and faster intubation.~   "
43496|NCT02997475|"~     The purpose of this study is to investigate areas of the brain responsible for~     self-regulation in adult women who have never had an eating disorder with women who have~     bulimia nervosa. More specifically, investigators are interested in changes in brain~     activation (e.g., changes in blood flow and oxygen use) when inhibiting responses and~     regulating emotions. Data collection will rely on a technology called functional magnetic~     resonance imaging (fMRI).~   "
43497|NCT02997462|"~     There are many treatments that can improve how long and how well people live with heart~     failure when they are outside the hospital. However, the investigators know less about how to~     effectively treat hospitalized heart failure patients so that they do not have to return to~     the hospital after they go home. Part of the problem is that the investigators don't~     understand all of the causes of worsening heart failure.~      Previous studies by other researchers suggest that white blood cells called monocytes are~     over-active in heart failure. Under normal conditions monocytes help fight infections in the~     body, but over-active monocytes release chemicals that could cause abnormal function of the~     heart and blood vessels. The investigators' research group believes that over-active~     monocytes may be an important reason that heart failure worsens before hospitalization.~      In this study the investigators will collect blood samples on the day a patient comes into~     the hospital, the day they return home, and the day they come back to the clinic for a~     follow-up appointment. The investigators will measure the inflammation in the bloodstream and~     the activity of monocytes from the patients' blood to see if there are changes in these~     measurements as heart failure improves. The investigators will also call each patient several~     times after they return home to ask questions about how they are doing.~   "
43498|NCT02997449|"~     Rationale: Accurate staging of lung cancer is important because it directs treatment and~     determines prognosis. The development of Stereotactic Ablative Radiotherapy (SABR), has~     revolutionized radiation therapy for early stage lung cancer and results demonstrate similar~     outcomes in comparison to surgical resection of the lung tumor. The staging work-up program~     for patients with a potentially resectable Non-Small-Cell Lung Cancer (NSCLC) includes at~     least a computed tomography (CT) scan of the chest and integrated Positron Emission~     Tomography - Computed Tomography (PET/CT) scans, and when indicated, invasive mediastinal~     staging. However, patients who are treated with SABR do not routinely undergo the same nodal~     staging work-up as do surgical candidates. As both surgery and SABR appear to achieve~     comparable rates of local and regional tumor control, it appears only logical to perform a~     similar staging work-up in all patients with early stage lung cancer who will be treated with~     either of the two curative local modalities. In the past, a lack of invasive nodal sampling~     before SABR was considered acceptable as invasive surgical staging (mediastinoscopy) was~     widely considered the preferred procedure. However, with minimally invasive and safe~     endosonography procedures now available, improved pre-treatment staging has become possible~     for patient groups who are eligible for SABR, including those with significant comorbidities.~      Hypothesis: Complete endosonographic (combined endobronchial and esophageal) staging of hilar~     and mediastinal lymph nodes in patients with (suspected) non-small cell lung cancer (NSCLC)~     will result in change of loco-regional nodal status in 20% of patients, in comparison to~     staging by PET-CT alone.~      Study population: Patients with either established or suspected early-stage NSCLC who are~     medically inoperable, or who refuse surgery but are potential candidates for SABR with~     curative intent (provided no intrathoracic metastases are present). Patients will undergo a~     single scope complete mediastinal and hilar staging procedure (combined EndoBronchial~     UltraSound (EBUS) and Transesophageal Endoscopic Ultrasound with EBUS scope (EUS-B)).~   "
43499|NCT02997436|"~     prospective interventional study. The aim is to analyse the effect of usual ongoing~     treatments over the microvascular cutaneous response to galvanic current application (Current~     induced vasodilation ; CIV) on the forearm of subjects referred for ultrasound investigations~     due to suspicion of peripheral artery disease. Hypothesis is that the use of aspirin (even at~     low dose) abolishes the response .~   "
43500|NCT02997423|"~     This is a multi-institutional, consortium-based, non-interventional prospective blinded~     endpoints clinical study to determine whether high activity of Cytochrome C Oxidase (CcO) in~     tumor specimens from subjects with newly diagnosed primary GBM is associated with shortened~     OS (primary outcome) and PFS (secondary outcome) times.~   "
43501|NCT02997410|"~     This study investigates the efficacy of bio-oxidative ozone application in the treatment of~     TMD of muscular origin.~   "
43502|NCT02997397|"~     In this study, the investigators aimed to find out the effect of a novel tourniquet~     technique, in cases of excessive bleeding during cesarean delivery.~   "
43503|NCT02997384|"~     This study aims to evaluate the feasibility (acceptability) of a consultation dedicated to~     informing women about their risk of breast cancer and the screening methods recommended for~     them according to the recommendations in force during a routine consultation at a general~     practitioner, a gynecologist or a radiologist.~   "
43512|NCT02997267|"~     The aim of the study was to compare the restoration of the GI tract by the closure of~     protective ileostomy after low anterior resection for rectal cancer after 14 days and more~     than 3 months.~   "
43513|NCT02997254|"~     This is a cohort study to evaluate algorithms for mapping atrial fibrillation and for~     detecting rotational activity.~   "
43504|NCT02997371|"~     Traumatic brain injury (TBI) is a common condition with high degree of morbidity and~     mortality (Hyder et al., 2007). Current treatment paradigms for TBI focus on mitigating~     secondary injury and maintaining cerebral physiology (Carney et al., 2016), however, there~     are currently no approved drugs that target the underlying conditions for patients suffering~     from TBI (Bullock et al., 1999). It is increasingly recognised that the innate inflammatory~     response to TBI may inflict injury (Lucas et al., 2006), and one of the most prominent~     mediators of inflammation in the injured brain is the Interleukin-1 (IL-1) receptor pathway~     (Allan et al., 2005). An endogenous antagonist to IL-1, is available in recombinant form~     (IL-1ra, Kineret), and is known to be safe in TBI (Helmy et al., 2014).~      In order to fully understand, and potentially optimize, the effect of Kineret, the~     investigators wish to conduct a dose-response study by giving three cohorts (n=20 per group)~     either placebo (isotonic saline), 1.5g or 3.0g of active substance administered intravenously~     in a double-blind, randomized setting. The concentrations have in previous studies not been~     shown to present any side-effects (Singh et al., 2014). The drug will be provided within 12~     hours after trauma. The goal will be to provide a dose-response effect on the cerebral~     inflammatory response. As secondary goals, the investigators will assess the brain damage by~     measuring proteins in blood and cerebrospinal fluid, functional outcome and inflammation in~     the brain using positron emission tomography.~   "
43505|NCT02997358|"~     The objective of LMS04 study is to better define the treatment strategy for patients with~     metastatic leiomyosarcoma (uterine or soft tissue), as well as identifying the best first~     line therapeutic option for these patients. LMS04 will test a new strategy for first line~     therapy LMS sarcoma compare to the reference therapy (6 cycles of doxorubicin alone): the~     interest of the association of trabectedin to doxorubicin in first line treatment followed by~     trabectedin alone for non-progressive patients after 6 cycles of the association of~     trabectedin and doxorubicin (the LMS02 design).~      LMS04 will be the first phase III randomized study specifically dedicated to soft tissue~     leiomyosarcoma in first line metastatic disease.~      It is planned to compare a new doxorubicin combination (including trabectedin) with very~     encouraging results followed by trabectedin maintenance therapy for non-progressive patients~     to doxorubicin alone. Prospective ancillary translational studies will attempt to define~     profiles of patients who could benefit from this new chemotherapy in an exploratory way.~      The validation of a new first line option specific for LMS, identifying clinical factors that~     characterize aggressiveness and responsiveness to treatment aims to have an important in the~     spirit of personalized medicine in this rare and deadly disease.~   "
43506|NCT02997345|"~     Preterm Premature Rupture of Membranes (PPROM) before 37 weeks of pregnancy is responsible~     for 40% of preterm births in the United States. The PPROM Registry aims to identify possible~     causes of PPROM, evaluate trends in expectant management, measure maternal and fetal care,~     and to review short term and long term outcomes of affected pregnancies and births.~   "
43507|NCT02997332|"~     The prognosis of patients with locally advanced SCCHN is poor. Results of recent randomized~     trials evaluating induction chemotherapy by docetaxel, cisplatin, 5 fluorouracil are~     conflicting, and benefit on overall survival is uncertain. Improve efficacy of induction~     chemotherapy is important without increase toxicities. Durvalumab is a promising agent in~     SSCHN. The safety of combination of docetaxel, cisplatin, 5 fluorouracil with durvalumab is~     unknown.~      The aim of the study is to evaluate the feasibility and the safety of the association of DCF~     (standard regimen for induction in SSCCHN) and durvalumab. The safety profile of DCF and~     durvalumab are different, so the expected toxicities should not be additive. The addition of~     durvalumab to DCF could improve the efficacy of induction chemotherapy and the prognostic of~     patients with SSCCHN.~      Concerning the translational research, the aim will be to explore the relationships between~     immune capacity, specificity, activation state and clinical outcome to help elucidate the~     determinants of response to immunotherapy.~   "
43508|NCT02997319|"~     The purpose of this study is to determine whether night time eating that coincides with~     elevated endogenous melatonin impairs glucose tolerance, particularly in carriers of the~     MTNR1B risk allele.~   "
43509|NCT02997306|"~     This is a randomized, controlled, prospective study which relies on computer-assisted skin~     image processing of scar photographs, to establish whether simple interrupted or running~     sutures are associated with the greatest degree of erythema when used to repair surgical~     defects arising from Moh's micrographic surgery (MMS) of facial skin cancers. Furthermore,~     through the use of the customized software that the investigators have developed for this~     purpose, an effort will be made to better understand the evolution (including progression and~     subsequent regression) of erythema over time in these scars.~   "
43510|NCT02997293|"~     The Enhanced Recovery After Surgery system for perioperative care of patients undergoing~     major abdominal surgery, particularly colorectal surgery, was formed in Europe by a surgeon~     named Henrik Kehlet in 1994. Dr. Kehlet observed that his patients undergoing colorectal~     surgery were hospitalized postoperatively for extended periods of time due to prolonged~     return of the normal intestinal physiology and of other bodily functions. He formulated a~     system of perioperative care that focused on preserving and promoting faster return of normal~     physiologic function of the human body following surgery.~      The Enhanced Recovery After Surgery system has been implemented in the United States for~     nearly a decade now, primarily at major academic institutions. Numerous publications exist~     that report the dramatic positive impacts of this program on reducing postoperative hospital~     length of stay, reducing 30-day hospital readmissions, and improving patient satisfaction.~      The University of Arkansas for Medical Sciences implemented several components of the~     Enhanced Recovery After Surgery system for colorectal surgery in June 2015. This is an~     observational study to look at the impact that program (Group 1) in shortening hospital~     length of stay, reducing postoperative narcotic consumption, lowering Visual Analog Scale~     scores, decreasing the incidence of postoperative nausea and vomiting, and reducing 30-day~     readmission when compared to patients who had colorectal surgery performed at University of~     Arkansas for Medical Sciences prior to the implementation of the Enhanced Recovery After~     Surgery system (Group 2).~   "
43514|NCT02997241|"~     The purpose of the study is to determine the relationship between change of gene copies and~     recurrence，and the overall survival at 5 years after chemotherapy based on clinical prognosis~     compared to Oncocare detection prognosis.~   "
43515|NCT02997228|"~     This randomized phase III trial studies how well combination chemotherapy, bevacizumab,~     and/or atezolizumab work in treating patients with deficient DNA mismatch repair colorectal~     cancer that has spread to other places in the body. Drugs used in chemotherapy, such as~     fluorouracil, oxaliplatin, and leucovorin calcium, work in different ways to stop the growth~     of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Monoclonal antibodies, such as bevacizumab and atezolizumab, may~     interfere with the ability of tumor cells to grow and spread. Giving combination~     chemotherapy, bevacizumab, and atezolizumab may work better in treating patients with~     colorectal cancer.~   "
43516|NCT02997215|"~     This study was to evaluate the effect of intraoperative intravenous lidocaine on~     postoperative pain management after laparoscopic cholecystectomy. Half of patients will~     receive intravenous lidocaine during procedure, the rest half of patients will receive~     regular anesthesia care and placebo treatment.~   "
43517|NCT02997202|"~     The purpose of this study is to compare relapse-free survival between participants with~     FLT3/ITD AML in first morphologic complete remission (CR1) who undergo hematopoietic stem~     cell transplant (HCT) and are randomized to receive gilteritinib or placebo beginning after~     the time of engraftment for a two year period.~   "
43518|NCT02997189|"~     This is a multicenter, Phase 2 study to assess the feasibility, safety and efficacy of~     OTO-104 given by intratympanic administration in subjects at risk for ototoxicity from~     cisplatin chemotherapy regimens in the treatment of cancer.~   "
43519|NCT02997176|"~     This is a trial to investigate the pharmacokinetics (PK) and the safety of talazoparib in~     patients with advanced solid tumors and impaired hepatic function.~   "
43520|NCT02997163|"~     This trial will investigate the pharmacokinetics (PK) and safety of talazoparib in patients~     with advanced solid tumors and impaired renal function.~   "
43521|NCT02997150|"~     NIL-2 is a clinical trial designed to evaluate the efficacy and safety of low doses of~     Interleukin2 in the treatment of recently diagnosed, steroid dependent idiopathic nephrotic~     syndrome in children. Recent data suggest that Interleukin 2 could be an effective therapy~     via an increased production of regulatory T cells.~   "
43522|NCT02997137|"~     Chronic psychological distress can lead to chronic exhaustion conditions, such as burnout.~     These conditions are associated with a deficiency of specific amino acids and micronutrients~     that cause endocrine-cardiometabolic abnormalities. These people have specific~     medically-determined nutrient requirements.~      Aim of this study is to demonstrate, that the daily oral administration of a specific amino~     acid composition (dosage 4.2 g/day) with micronutrients (e. g. 7 vitamins of the B-complex,~     magnesium, zinc) designed to decrease chronic exhaustion conditions will significantly~     decrease the perceived chronic distress and associated chronic exhaustion conditions of women~     and men after 8 and 12 weeks.~   "
43523|NCT02997124|"~     The purpose of this study is to determine whether a supplemental Transversus Abdominis Plane~     block administered intraoperatively improves the postoperative parameters in patients~     undergoing Alveolar bone grafting with iliac crest harvest. It also aims to find out if there~     is a decrease in the incidence of chronic pain or numbness at the harvest site.~   "
43524|NCT02997111|"~     This study evaluates the responsiveness of the Platelet Function Analyzer (PFA-100) to the~     effect of energy drinks on platelet function. Participants' will have blood drawn prior to~     and 60 minutes after ingesting 250ml of a commercially available sugar-free energy drink.~   "
43525|NCT02997098|"~     This observational registry of patients undergoing liver surgery collects patients both~     retrospectively and prospectively. Patients undergoing liver resection for any non-transplant~     indication will be evaluated for clinical outcomes (such as surgical complications, survival,~     and disease progression) based on clinical and patient factors (like indication, age, and~     other treatments for the disease).~   "
43526|NCT02997085|"~     Virtual Reality (VR) is one non-pharmacological method that has shown promise as an effective~     means of decreasing pain levels following treatment, and for significant periods of time.~     Additionally, neurobiology studies of VR have demonstrated a decrease in brain activity~     associated with pain. While VR is clearly a promising, drug-free option for pain treatment,~     existing VR systems are expensive and use unconvincing graphics. Recent advances in VR~     technology (i.e., improved realism and immersion using 360-degree 3D technology and more~     affordable delivery systems) allow the development of more realistic and more cost-effective~     applications. Capitalizing on these advances and the investigators' experiences with VR~     intervention development and evaluation, the current study will test a state-of-the-art VR~     experience in pain management intervention (Live-Action 360° Video Virtual Reality(VVR)) and~     compare it to established standard computer generated imagery (CGI) 360° VVR content for pain~     management intervention in a medical setting. The participant's participation will help the~     investigators determine which VR intervention is most effective in reducing acute pain in~     hospital patients.~   "
43527|NCT02997072|"~     The purpose of this study is attempt to establish optimum drive pressure of high frequency~     jet ventilation during rigid bronchoscopy to ensure good aeration of the lungs examined by~     electrical impedance tomography.~   "
43528|NCT02997059|"~     This was prospective study randomized in two controlled parallel groups verum versus placebo.~     The objectives were to assess the influence of antifungal treatment with Fluconazole (FCZ) on~     the rate of ASCA and endoscopic recurrence at 6 months. The rational was based on our~     previous research having established i) a link between intestinal inflammation and the~     opportunistic fungal pathogen C. albicans -a yeast colonizing the human digestive tract- ii)~     the demonstration that this yeast species could be at the origin of ASCA, a prominent~     serological marker of CD. It was therefore hypothesized that the FCZ could lower the rate of~     ASCA and/or reduce the occurrence of recurrences.~   "
43579|NCT02996396|"~     Multicenter, single arm, open label, registry study with consecutive, eligible patient~     enrollment at each site. All subjects undergoing the Endovascular Aneurysm Sealing System~     (EVAS) with the Nellix®-System. Subjects will be followed procedurally to discharge, and as~     per institutional standard of care thereafter through to 5 years (total follow-up commitment)~   "
43706|NCT02994719|"~     The purpose of this study is to investigate whether speed-dependent measures of gait can be~     identified in patients with neurological conditions that affect gait, particularly in~     subjects with parkinsonian disorders.~   "
43529|NCT02997046|"~     Conventional vascular imaging techniques are often either contra-indicated in chronic kidney~     disease (CKD) patients due to their relative invasiveness, risks and cost. Computed~     tomography angiography (CTA) requires radiation and nephrotoxic iodinated contrast which may~     precipitate significant worsening of renal function and even prompt the need for institution~     of dialysis. Magnetic resonance angiography (MRA) using gadolinium-based contrast agents has~     been associated with the rare disease nephrogenic systemic fibrosis. Alternative imaging~     methods also have drawbacks: for example, this frail patient group has a higher risk of~     complications from conventional invasive catheter-based angiography, non-contrast-enhanced~     MRA allows visualization of smaller arteries but is less accurate for larger vascular~     structures, and ultrasound is often not appropriate for evaluation of the deep vessels of the~     abdomen and pelvis.~      Ferumoxytol is an ultrasmall superparamagnetic iron oxide particle encapsulated by a~     semisynthetic carbohydrate, which was initially developed as a magnetic resonance imaging~     (MRI) contrast agent in 2000. However, interest in ferumoxytol as a therapeutic agent for the~     treatment of iron deficiency anaemia in the setting of CKD eclipsed its use as MRI contrast~     agent. During the last decade, ferumoxytol has gained appeal as an MRI contrast agent in~     patients with estimated glomerular filtration rates <30mL/min and there are reports in the~     literature for its safe use and utility in both adult and pediatric patients with CKD.~      Participants will be selected from those who have been referred for assessment prior to~     kidney transplant or prior to vascular access creation for haemodialysis and will be divided~     into three groups. The first group will include patients who will undergo a CTA of abdominal~     and aortoiliac vasculature as part of their preparation for potential kidney transplantation.~     The second and third groups will include patients who are having a fistula or a graft created~     for dialysis, respectively. These patients are routinely having US vascular mapping to~     visualise the blood vessels before a fistula or a graft is created. Additionally, patients~     included in the second and third groups are routinely having surveillance scans of their~     fistula or graft at 6 weeks following creation. Study participants undergoing standard~     imaging tests as part of their clinical care will also have ferumoxytol-enhanced MRA (FeMRA).~   "
43530|NCT02997033|"~     Population-based, longitudinal cohort study designed to evaluate changes in bone mineral~     density, bone geometry, body composition, parameters reflecting muscle force, and sex steroid~     status in healthy young men, as well as their interactions, over a period of +-10 years.~   "
43531|NCT02997020|"~     The purpose of this study is to establish the novel endoscopically-directed sinus potential~     difference (EDSPD) assay as an endpoint for therapy of sinus disease.~   "
43532|NCT02997007|"~     Healthy ageing and pathological ageing in the context of a neurodegenerative disease are both~     associated with changes in brain network integrity. Episodic memory is especially affected in~     Alzheimer's disease, but is also decreased in healthy ageing. Consequently, the~     memory-relevant brain networks are especially altered. Transcranial direct current~     stimulation (tDCS) has previously been implemented in different clinical- and non-clinical~     settings and has shown to beneficially influence network connectivity. The neural correlates~     of single-session tDCS have been investigated, however, the neural effects of repeated tDCS~     remain unknown. Furthermore, knowledge about the (long-term) neural mechanisms of repeated~     tDCS can give valuable insights and possibly pave the ground for exploring tDCS as a~     treatment option in future studies.~   "
43533|NCT02996994|"~     This is a retrospective chart review using TriHealth Electronic Privacy Identification Center~     (EPIC) and previously developed databases for TriHealth Institutional Review Board (IRB)~     approved research studies within the Division of Urogynecology and Reconstructive Pelvic~     Surgery to determine the predictors of postoperative pain specific to the urogynecologic~     patient population.~   "
43534|NCT02996981|"~     This is a retrospective chart review using Electronic Privacy Identification Center (EPIC)~     database to determine if the addition of cranberry juice capsules to our discharge medication~     regimen for patients discharged home with an indwelling urinary catheter following pelvic~     floor gynecology surgery reduced the incidence of UTI.~   "
43535|NCT02996968|"~     This study is to determine if self-discontinuation of transurethral foley catheters in~     patients diagnosed with postoperative urinary retention (POUR), which is defined as the~     continued need for catheterization, following impatient pelvic organ prolapse surgery is~     non-inferior to office-discontinuation.~   "
43536|NCT02996955|"~     Low back pain is worldwide a common musculoskeletal condition with a high number of~     recurrences. Recurrence rate and the number of recurrences could be reduced and time to a~     next episode could be prolonged by advising an active lifestyle. Advising regular physical~     activity is the mainstay in physical therapy treatment. This includes an appeal to patients~     to adhere to an activity advice. Patient adherence to an activity advice is poor. In this~     study an intervention consisting of treatment of illness perceptions with or without~     organizing social support to increase adherence to an activity advice will be investigated.~      The primary objective of this study is to investigate whether social support by a partner or~     friend and treatment of patients' illness perceptions influences the rate of adherence to an~     activity advice compared to treatment of patients' illness perceptions alone in patients~     suffering non-specific low back pain. Secondary objectives are; a) whether 'treatment of~     illness perceptions' changes patients' maladaptive illness perceptions into realistic ones,~     b) whether maladaptive illness perceptions, comorbidity and/or overweighed/obesity and/or~     rate of recurrences of non-specific low back pain and/or attitude and intention to physical~     activity influences patient's adherence .~      This study is a multi-centre randomized two-arm controlled clinical trial. Patients ≥18 years~     presenting with at least a second episode of non-specific low back pain.~      Patients in the intervention and control group will be asked to perform a physical activity~     advice. During two physiotherapy treatment sessions treatment of illness perceptions is~     performed in both groups. In the intervention group organizing social support by a partner or~     friend is added.~      Twenty-five percent absolute improvement of walking and/or cycling according the NNGB in the~     intervention group is clinically relevant.~      During four appointments several questionnaires have to be filled in and during two~     physiotherapy treatment sessions half an hour treatment of illness perceptions will be~     performed. Social support by a partner or friend will be organized during the same~     physiotherapy treatment sessions in the intervention group. During three separate weeks~     patients have to wear an activity monitor. Patients will be treated according to the Dutch~     Low Back Pain guideline; no adverse effects will be expected.~   "
43537|NCT02996942|"~     The KAPPa project has the aim to create an international database in which information about~     clinical features, therapeutic management, burden of illness and costs of severe and moderate~     haemophilia A patients from different countries and sites is collected. The aim of this~     project is to analyse the influence of such different characteristics on medical,~     psychosocial and economic outcomes in patients over the long-term.~   "
43538|NCT02996929|"~     The study's main purpose is to evaluate the safety and performance of the LeadExx LC System~     and its ability to safely extract leads.~      The study will enroll 10 patients scheduled for CIED lead extraction. The decision upon lead~     extraction will be based upon the applicable Heart Rhythm Society guidelines or European~     Heart Rhythm Association (EHRA).~   "
43539|NCT02996916|"~     Hypertension is a leading risk factor for morbidity and mortality worldwide. The brain is a~     major target of the damaging effects of hypertension. Hypertension has been recognized as the~     leading cause of dementia as well as the most important risk factor for stroke and vascular~     cognitive impairment. Although glucose is the principal cerebral energy source, impact of~     hypertensive treatment on cerebral glucose metabolism is poorly understood.~   "
43595|NCT02996188|"~     The aim of our study was to evaluate hemodynamic changes during routine paracentesis in tense~     ascites using non-invasive inert gas rebreathing.~   "
44088|NCT02989727|"~     The purpose of this study is to determine if patients with melancholic bipolar II depression~     are more responsive to lamotrigine than patients with non-melancholic bipolar II depression.~     To do this, the investigators will re-analyze a previous clinical trial that evaluated~     lamotrigine as a treatment for bipolar II depression (GSK-SCA100223; NCT00274677).~   "
43540|NCT02996903|"~     The Prospective Multicenter Registry On RadiaTion Dose Estimates Of Cardiac CT AngIOgraphy~     IN Daily Practice in 2017 (PROTECTION-VI) study is a prospective registry and~     investigator-initiated initiative without third-party funding, which will collect and analyze~     the radiation dose exposure of Cardiac Computed Tomography Angiographic (CCTA) studies in~     current daily practice worldwide. Particularly, the study will assess the use of strategies~     for dose reduction during CCTA.~      A decade ago, the multicentre observational PROTECTION-I study has revealed that the~     dose-length-product of CCTA ranges between 568 - 1259 mGy x cm with a median of 885 mGy x cm.~     This corresponds to an estimated effective dose of approximately 12 mSv. Since then a variety~     of techniques have been developed and enhanced in order to reduce radiation exposure during~     CCTA. Recent studies demonstrated feasibility of dramatically reduced effective radiation~     doses during CCTA (0,1 - 0,3 mSv). This has been executed in small cohorts of patients at~     scientific expert centers. However, it remains unclear, if such low-level radiation dose~     exposure may be achieved in clinical routine and if diagnostic image quality is maintained.~     In order to analyze the magnitude of radiation dose exposure of CCTA in today's clinical~     practice and the current use of dose-saving techniques, we designed the PROTECTION-VI study.~     Eventually, this study may contribute to further improving radiation dose exposure for~     patients undergoing CCTA.~   "
43541|NCT02996890|"~     Double blinded, randomized, placebo-controlled, dose finding, multi-center, phase 1 trial in~     48 healthy volunteer subjects.~      After completion of screening procedures, the subjects are randomized to one of four~     treatment groups (different dosage strengths and placebo) All subjects will receive study~     treatment at day 0 and will return on day 28. Subjects randomized to treatment groups with~     two vaccinations will receive a second treatment at day 28.~      Subjects will return on day 56 for the final visit.~   "
43542|NCT02996877|"~     The OPTIMUM registry is a minimal risk observational study that uses a prospective cohort~     design to follow patients who have multivessel or left main coronary artery disease~     (surgical anatomy according to ACC/AHA Appropriateness Criteria for PCI12) and are deemed~     ineligible for coronary artery bypass surgery. It is anticipated that 20 sites will be~     selected to participate in the registry from a national network of leading centers across the~     United States with recognized expertise in both complex PCI and coronary artery bypass~     surgery. We will invite leading cardiac centers, as defined by US News and World reports~     rankings for heart care. Additional sites may be added to meet the target enrollment goal.~   "
43543|NCT02996864|"~     College students are in a newly independent phase of life; many of whom encounter unhealthy~     dietary decision- making, barriers to physical activity, and poor sleep behaviors. Healthy~     Detours is a location-based smartphone application tailored in real-time to a student's~     schedule and locale, and aims to guide students toward healthier eating, exercise, and~     lifestyle choices as a way to prevent the onset of damaging and costly health outcomes.~     Through a randomized control trial, this Phase II project will test the effectiveness of an~     evidence-based smartphone application that will provide students with on-demand,~     location-specific information about healthy lifestyle choices.~   "
43544|NCT02996851|"~     Oral antithrombotic medications (OAM) are used for the prevention and treatment of thrombotic~     disorders. Among hemorrhagic complications of OAMs, intracranial hemorrhage (ICH) may have~     particularly devastating consequences with high morbidity, disability and mortality rates.~     The efficacy and safety profiles of OAMs are generally assessed in randomized controlled~     trials (RCT), but included patients are often highly selected and may not be representative~     of users in everyday clinical practice in terms of follow-up routines, age, gender, drug~     compliance, and polypharmacy. Moreover, it is often unclear whether or not traumatic ICHs are~     registered and reported in RCTs. Drifts in indications and treatment criteria may also be~     seen in everyday practice and drug discontinuation due to precautionary concerns including~     compliance, fall risk and comorbidity may be forgotten. Collectively, these factors may lead~     to other and potentially higher traumatic ICH rates in general clinical use than reported in~     RCTs.~      The incidence rates of traumatic ICH in patients on OAMs in the general population remain~     unknown. In this nationwide registry based pharmacoepidemiological study we will investigate~     the incidence and case fatality of traumatic ICH in users of OAMs in Norway from 2008 through~     2014.~   "
43545|NCT02996838|"~     To study the pharmacokinetic characteristics of TQ-B3234 in the human body, recommend a~     reasonable regimen for subsequent research.~   "
43546|NCT02996825|"~     This phase I trial studies the side effects and best dose of mirvetuximab soravtansine and~     gemcitabine hydrochloride in treating patients with folate receptor (FR) alpha-positive~     ovarian, primary peritoneal, fallopian tube, endometrial, or triple negative breast cancer~     that has come back. Monoclonal antibodies, such as mirvetuximab soravtansine, may interfere~     with the ability of tumor cells to grow and spread. Drugs used in the chemotherapy, such as~     gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either~     by killing the cells, by stopping them from dividing, or by stopping them from spreading.~     Giving mirvetuximab soravtansine and gemcitabine may work better in treating patients with~     FRalpha-positive ovarian, primary peritoneal, fallopian tube, endometrial, or triple negative~     breast cancer.~   "
43547|NCT02996812|"~     This study is designed to evaluate the safety, efficacy, and pharmacokinetic profile of~     single ascending doses of exendin 9-39 administered by subcutaneous route in subjects with~     post-bariatric hypoglycemia.~   "
43548|NCT02996799|"~     For preterm infants, deferred cord clamping has been shown to improve both short term and~     long-term neonatal outcomes without an established harm for both the mother and her~     infant.The interference with resuscitative measures for the neonate or the mother is a risk~     that continued to hamper the implementation of delayed cord clamping in many centers around~     the world.For that reason, the evidence now is seeking a time-honored, yet not adopted method~     of placental transfusion that involves milking of the umbilical cord.~   "
43549|NCT02996786|"~     The aim of this study is to examine the beneficial effects of Danggui Buxue Tang on blood~     biochemical parameters in male recreational runners.~   "
43792|NCT02993601|"~     The study aims at assessing the usefulness of the Heartfelt1 device in patients suffering~     from heart failure, who have peripheral oedema. The device is non-contact and does not~     requires patient compliance to work. It gives an output reading of the patient's lower leg~     volume.~      During the study, this measurement will be compared to clinical standard and gold standard~     measurements as well as clinical grading of peripheral oedema.~   "
43550|NCT02996773|"~     The purpose of this study is to evaluate the safety and efficacy of substituting day +4~     cyclophosphamide with post-transplant bendamustine in myeloablative (MAC) or reduced~     intensity conditioning (RIC) haploidentical hematopoietic cell transplantation (HHCT) for~     advanced leukemia and lymphoma patients.~      The phase I component of the study is to evaluate the safety of completely substituting the~     second dose of post-transplant cyclophosphamide (PT-CY) given on day +4 with bendamustine~     (PT-BEN).~      The phase II component of the study will continue to evaluate the safety and efficacy of~     subjects who receive PT-CY on day +3 and PT-BEN on day +4.~      Approximately, a total of 32 subjects will be treated under this protocol. Approximately 12~     to 15 subjects will be used as control, subjects that receive no PT-BEN, for direct~     comparison.~   "
43551|NCT02996760|"~     Women in assisted reproduction treatment they receive own or donated embryos and presenting~     an endometrial development less than 5 mm despite having received treatment with estrogen~     therapy knowing the clinical value of using the PRGF-Endoret therapy and endometrial level~     applications to improve endometrial thickness endometrial preparations for embryo transfer.~   "
43552|NCT02996747|"~     The purpose of this project is to verify possible clinical and radiological findings with~     regard to distinguishing enchondroma from low grade chondrosarcoma of the long bones. In~     addition, this study presents the outcome of patients with enchondroma and low grade~     chondrosarcoma of the long bones who were treated with curettage (intralesional surgery).~   "
43553|NCT02996734|"~     The purpose of this project is to present the outcomes of patients with giant cell tumor of~     bone (GCTB) who were treated with surgery and/or medical treatment in a single institution.~   "
43554|NCT02996721|"~     This study evaluates whether achieving 25-hydroxyvitamin D (25[OH] Vit D) levels (>40 ng/mL)~     among myocardial infarction patients will result in a reduction of cardiovascular-related~     adverse events. Half of the patients will be randomized to receive standard of care and half~     will receive clinical management of 25[OH] Vit D levels.~   "
43555|NCT02996708|"~     The purpose of this study is to determine whether Teleconsultation would a)be effective and~     cost-effective by increasing the proportion of patients with Autism Spectrum Disorders having~     a correct follow-up, and less transportation, and b) get a high satisfaction from the parents~     and from the professionals~   "
43556|NCT02996695|"~     Single site, double-blinded, randomized, placebo-controlled clinical trial of PfSPZ-CVac~     safety, tolerability, immunogenicity and efficacy against naturally occurring malaria in~     malaria-exposed Malian adults. The overall goal of the study is to evaluate if a regimen of~     PfSPZ-CVac (PfSPZ Challenge under chemoprophylaxis) is safe, well-tolerated, and provides~     sterile protection against naturally-occurring malaria in malaria-experienced adults. The~     study population includes 62 healthy, malaria-experienced adults aged 18-45 years, inclusive,~     residing in Bougoula Hameau and surrounding villages, Mali.~   "
43557|NCT02996682|"~     The primary objectives of this study are to evaluate the antiviral efficacy, safety, and~     tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) with or without~     ribavirin (RBV) for 12 weeks in adults with chronic HCV infection and decompensated~     cirrhosis.~   "
43558|NCT02996669|"~     This is a multicenter longitudinal study that aims to identify, develop and validate a set of~     measures that can be used as stratification biomarkers and/or sensitive and reliable~     objective measures of social impairment in autism spectrum disorders (ASD) that could serve~     as markers of long term clinical outcome. The main study will include 275 individuals: 200~     ASD subjects between 6-11 years old, and 75 TD subjects roughly matched by age and sex to the~     ASD group.~   "
43559|NCT02996656|"~     INESS Antibiotic Prophylaxis in Orthopedic Guide recommends the use of Cefazolin at induction~     for all orthopaedic procedure with implantation of internal fixation device. With the~     increasing rate of identified P. acnes shoulder surgery infection despite the use of~     recommended skin preparation and preoperative prophylactic antibiotics, a question arises; Is~     Cefazolin the most effective prophylactic antibiotic for shoulder surgery? The objective of~     this study is to determine if Ceftriaxone is superior to Cefazolin as a prophylactic~     antibiotic for skin colonization with P. acnes in primary shoulder surgery~   "
43560|NCT02996643|"~     Adolescent Idiopathic Scoliosis (AIS) is a three-dimensional deformity of the spine~     associated with vertebral rotation. Brace treatment is the most commonly used non-surgical~     treatment. To obtain the best possible outcome, the best in-brace correction within the~     patient's accepted tolerance must be provided. However, in the existing clinical practice,~     the immediate in-brace correction cannot be measured during the design and fitting of the~     brace because the correction is determined using a radiograph. This study is to evaluate the~     effect of applying ultrasound to measure the stimulated in-brace correction during brace~     casting.~   "
43561|NCT02996630|"~     Congenital heart disease (CHD) is the most prevalent congenital malformation affecting 1 in~     100 newborns per year. Children with CHD are a known risk population for brain injury, with~     neurodevelopmental alterations shown over time in up to 50% of cases. No adequate description~     exists of the type of neurocognitive anomalies or risk factors associated with CHD, and~     consequently no prognostic markers that may allow identification of high-risk cases are~     available.~   "
43562|NCT02996617|"~     Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor~     to limit the dosage and the continuation of chemotherapy. The PEG-rhG-CSF has increased~     plasma half-life, and prolonged efficacy in compare with rhG-CSF. The purpose of this study~     is to determine the safety and effectiveness of PEG-rhG-CSF in preventing neutropenia~     following chemotherapy in patients with non-Hodgkin lymphoma.~   "
43563|NCT02996604|"~     He-Mu-point combination（ST36 and CV12） is one of the most commonly used acupoints combination~     with synergistic effect for functional dyspepsia(FD). The investigators design the trial to~     identify the efficacy and explore the central integrated mechanism of puncturing at~     He-Mu-point combination on FD with functional magnetic resonance imaging (fMRI).~   "
43610|NCT02995993|"~     Six patients with Fabry disease will be recruited. Patients will receive a single dose of 0.2~     mg/kg recombinant human alpha-galactosidase A produced in moss (moss-aGal) as intravenous~     infusion. Patients will be hospitalized during the infusion and for at least 24 hours after~     the end of the infusion. Treatment will be administered sequentially: if a patient shows no~     safety concerns on the treatment day, treatment of the next patient will commence on the~     following day.~   "
43564|NCT02996591|"~     The purpose of this study is to determine if there is a difference in patient outcomes with~     general anesthesia versus spinal anesthesia when given in addition to popliteal and adductor~     canal nerve blocks for foot and ankle surgery. Popliteal and adductor canal nerve blocks are~     injections of local anesthetic agents near nerves in the back and front of the knee going to~     the foot and ankle that provide numbness during and after surgery. These peripheral nerve~     blocks offer good pain control and reduce the need for opioids (opioids are pain medications~     such as morphine, Dilaudid, and oxycodone). General anesthesia involves the flow of oxygen~     and anesthesia gas through a tube which, along with additional intravenous medications,~     causes unconsciousness and unawareness of sensations during surgery. Spinal anesthesia~     involves an injection of local anesthetic in the lower back, which causes numbness below the~     waist. In addition to spinal anesthesia, a sedative is typically given intravenously to cause~     relaxation and sleepiness throughout surgery.~      General, spinal, and nerve block anesthesia are all routinely used for surgery at the~     Hospital for Special Surgery. General or spinal anesthesia is typically used in addition to~     peripheral nerve blocks during foot and ankle surgery to 1) allow the surgeons to use a thigh~     tourniquet to reduce bleeding, 2) provide anesthesia earlier, and 3) prevent unwanted~     movement. However, it is unclear whether general or spinal anesthesia provides better patient~     outcomes when given with peripheral nerve blocks. Some reports show that on its own, spinal~     anesthesia has advantages over general anesthesia in terms of side effects such as nausea and~     pain. However, these advantages may also be gained from combining peripheral nerve blocks~     with general anesthesia. Spinal anesthesia can be associated with headache and backache,~     although headache and backache can also happen after operations performed with general~     anesthesia. A previous study at the Hospital for Special Surgery showed low rates of nausea~     among patients who received nerve blocks with spinal anesthesia, and no nausea among patients~     who received a nerve block with general anesthesia. Therefore, the primary aim of this study~     is to determine if, as a treatment, either general or spinal anesthesia has advantages over~     the other treatment in terms of readiness for discharge, side effects, pain and patient~     satisfaction in an ambulatory foot and ankle population.~   "
43565|NCT02996578|"~     This project aims to investigate whether consumption of cocoa polyphenols has an impact on~     cognitive function in individuals aged 50 to 60 years of age and if such an improvement is a~     result of an improvement in risk factors associated with cognitive decline in ageing.~   "
43566|NCT02996565|"~     This pragmatic trial will compare two team-based care models for managing hypertension, Best~     Practice Clinic-based Care and Telehealth Care with pharmacist management, in a large care~     system in Minnesota. Clinics in the study are randomized to offer one of the two treatment~     models to participants with uncontrolled hypertension.~      The investigators aim to determine a) whether one model is more effective than the other for~     lowering patient's blood pressure and b) which model patients prefer.~   "
43567|NCT02996552|"~     The surgical treatment of less than severe (≤2+/4+) functional tricuspid regurgitation (TR)~     in patient undergoing mitral valve surgery, is still controversial: some observational~     studies have suggested that performing tricuspid annuloplasty in patients undergoing mitral~     valve surgery with a dilated tricuspid annulus, and TR≤2+ may provide a clinical benefit,~     while in other observational studies such benefit has not been documented.~      The ESC Guidelines assign the class IIa recommendation for surgical treatment in patients~     with tricuspid regurgitation ≤2+ and a dilated annulus, if surgery is concomitant to the~     repair or replacement of the mitral valve. However the level of evidence C (expert opinion)~     confirms the absence of clear scientific evidence to support this recommendation.~      It is therefore very important to carry out randomized trials designed to really prove the~     supposed efficacy of prophylactic tricuspid annuloplasty, especially in patients with~     degenerative etiology where the data are particularly controversial.~      The aim of the study will be to establish the effectiveness of the tricuspid annuloplasty in~     the early stage of TR. The investigators enrolled patients with TR≤2+ and annular dilation~     undergoing mitral valve repair.~      Primary end-point will be the freedom from recurrence of TR≥3+ and from progression of 2~     degrees of TR compared to pre-operative, at discharge and 12 months after surgery, assessment~     by transthoracic echocardiography. Secondary endpoints are to demonstrate the superiority of~     combined treatment (M & T Repair Group) compared to single treatment (Mitral-Only Group) at 5~     and 10 years after surgery.~      This will be an experimental superiority, prospective, spontaneous, multicenter, randomized~     trial.~      Patients will be randomly assigned to two parallel arms with an allocation ratio 1:1~     stratified by center, to receive mitral repair only (Mitral-Only group) or both mitral and~     tricuspid repair (M & T Repair group).~   "
43568|NCT02996539|"~     Several studies have investigated an association between cardiac autonomic neuropathy (CAN)~     and albuminuria, glomerular filtration rate, or both, and hypothesized that CAN is involved~     in the pathogenesis of nephropathy. However, most of these studies had focused on Caucasians~     and were limited to a small number of patients with type 1 diabetes mellitus, or had used a~     conventional Ewing battery of tests based on dynamic cardiovascular maneuvers.Yet, there is~     consistent data showing that Asian diabetic populations, including the Chinese, have a higher~     risk of renal complications than Caucasians do.~      The present study investigated an association between heart rate variability (HRV) parameters~     and diabetic kidney disease (DKD) in Chinese type 2 diabetes mellitus (T2DM) patients,~     specifically through time and frequency domain analyses of HRV and urine albumin creatinine~     ratio (UACR) or estimated glomerular filtration rate (eGFR).~   "
43569|NCT02996526|"~     Population-based single centre, blinded, prospective cohort study of the impact of recurrent~     laryngeal nerve (RLN) injury on Thoracic Surgery patients. The principal outcome of interest~     is the effect of RLN injury on respiratory complications. Voice, swallowing, cardiac and~     mortality outcomes will also be determined.~   "
43570|NCT02996513|"~     For assessing body retinol pools in preschool children, it is recommended that a blood sample~     is taken 14-21 days after isotope dosing. During this period, dietary intake of vitamin A~     should be controlled. Shortening of this period as has been validated for adults would reduce~     the burden for the children as well as improve research efficiency. The aim is to validate a~     4-day protocol for assessing body retinol pools in preschool children by modelling data~     derived by retinol isotope dilution (RID) method. Venous blood samples will be collected of~     60 children 4 days after dosing of 0.4 mg 13C-labeled retinyl acetate. A second venous blood~     sample will be collected at 6, 8, 12 hrs; and 1, 2, 4, 7, 11, 16, 22 and 28 days after dosing~     in subgroups of 6 children, randomly divided over the 10 additional time points. Body retinol~     pools will be modelled, and the time point at which a parsimonious model applies (presumably~     at day 4) will be assessed.~   "
43571|NCT02996500|"~     This is a Phase 2, multicenter, randomized, double blind, double dummy, placebo and~     active-controlled, parallel group study to assess the efficacy and safety of PF 06650833 at~     Week 12 in subjects with moderate-severe, active, RA who have had an inadequate response to~     MTX. PF-06650833 or matching placebo tablets will be administered orally QD under fasting~     conditions, and tofacitinib or matching tofacitinib placebo tablets will be administered~     orally BID for 12 weeks in a blinded fashion.~   "
43572|NCT02996487|"~     The goal of this study is to evaluate whether using vancomycin orally can prevent CDI in~     patients who are colonized with C. diff who are admitted to the hospital and need antibiotics~     for another infection.~   "
43611|NCT02995980|"~     This is a feasibility study to evaluate dual-energy (DE) contrast-enhanced (CE) digital~     mammography to detect breast cancer in patients with increased breast density (BI-RADS~     category c or d). Eligible patients will be invited to have full-field digital mammography~     and dual-energy (DE) contrast-enhanced (CE) digital mammography to compare accuracy of the~     imaging methods for the detection of breast cancer.~   "
43793|NCT02993588|"~     The purpose of this study is to investigate the impact of melatonin administration on in~     vitro fertilization (IVF/ICSI) outcomes namely the total number and quality of the oocytes~     and embryos in the prospective poor responders.~   "
43573|NCT02996474|"~     Background:~      Acute myeloid leukemia (AML) is a cancer of the white blood cells. It is fatal if not~     treated. Treatment for AML that has not responded to treatment (refractory) or has returned~     after treatment (relapsed) often do not work. Researchers want to see if an immunotherapy~     drug, combined with a less intense chemotherapy, may be able to help.~      Objective:~      To test if pembrolizumab, in combination with decitabine, is a possible treatment for people~     with relapsed or refractory AML.~      Eligibility:~      Adults 18 years of age and older with refractory AML or relapsed AML.~      Design:~      Participants will be first screened for eligibility.~      The study is counted in 21-day cycles. The initial phase of the study consists of 8 cycles.~     Participants may be in the study for up to 2 years if they are responding to the treatment.~      The first 3 weeks of treatment is usually done in the hospital. The rest may be done as an~     outpatient.~      Participants will get pembrolizumab at the beginning of each cycle through an IV.~      Participants will usually get decitabine by IV on days 8 12 and days 15 19 of every other~     cycle.~      Participants will give blood samples.~      Participants will have bone marrow exams. A needle will be inserted into the hip to extract~     cells from the bone marrow.~      Some participants may give a sample of saliva from the inside of their cheek.~      Some participants may give a small skin sample. The top layer of the skin is removed.~      Some patients may require leukapheresis before starting treatment. This is a procedure to~     remove leukemia cells in the blood stream.~   "
43574|NCT02996461|"~     Background:~      People get Zika virus from infected mosquitos. They usually don t get very sick. But birth~     defects were reported in babies born to mothers who had Zika infection. In rare cases, people~     with Zika infection had a nervous system disease that causes severe muscle weakness and can~     be life threatening. A new vaccine made from DNA in the code for a Zika virus protein could~     help the body build an immune response against the virus.~      Objectives:~      To see if a new vaccine against Zika virus disease is safe and causes any side effects. To~     study specific immune responses to the vaccine.~      Eligibility:~      Healthy people ages 18-50~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Urine tests~      Participants will have 18 visits over 2 years.~      Participants will be randomly assigned to 1 of 3 groups. All will get 3 vaccines at 3~     separate monthly visits. They will receive the vaccine in the upper arm muscle. Some will get~     it by needle and syringe, others by a device that uses high pressure to push the vaccine~     through the skin.~      Vaccine visits last 4-6 hours. Participants will get a thermometer to measure their~     temperature and a ruler to measure any skin changes at the injection site. They will record~     this data for 7 days after each injection.~      Other visits last 1-2 hours. These include:~      Evaluation of any health changes or problems~      Blood tests: Some samples may be used for future research.~      Participants with side effects may have extra visits.~   "
43575|NCT02996448|"~     Background:~      AD-HIES is a disease that weakens the immune system. It puts people at risk for infections,~     particularly Staph and Candida infections. Researchers want to test a vaccine that may help~     keep people from getting these infections, which would help people with AD-HIES.~      Objective:~      To test the new vaccine NDV-3A for protection against infection from the yeast Candida and~     the bacterium Staphylococcus aureus (Staph).~      Eligibility:~      Adults ages 18-55 who have AD-HIES~      Healthy volunteers ages 18-55~      Design:~      Participants will have 6-7 study visits over 6-7 months. They will also be contacted by phone~     in between some visits.~      Participants will be screened with a medical history, physical exam, and blood and urine~     tests.~      Participants will have 2 baseline visits. They will have repeat the screening tests. They~     will have samples of saliva, stool, skin, mucus (oral, nasal, and/or vaginal) collected.~     Vaginal and stool samples are optional. Any eczema on their skin will be looked at.~      Participants will fill out symptom diary cards to record how they feel.~      Participants will have the NDV-3A vaccine injected into a muscle in the arm.~      Participants will return the next 2 days. They will have a physical exam. Blood will be~     collected.~      Participants will have 2 more follow-up visits at the NIH. They will have a physical exam.~     They will have blood, saliva, stool, skin, vaginal fluid, and/or mucus samples collected.~     Vaginal and stool samples are optional.~      Participants will be called once a month for 5 months after the vaccination. There is an~     optional visit about 6 weeks after the vaccination. Participants will provide a blood sample~     at this visit.~   "
43576|NCT02996435|"~     The primary purpose of this study is to evaluate the effectiveness of an intervention with a~     mobile adherence platform, compared to physician- or nurse-guided standard of care, to~     improve medication adherence to rivaroxaban in participants who have recently initiated~     treatment with rivaroxaban for stroke prevention in atrial fibrillation based on an~     assessment of the proportion of days covered (PDC) of rivaroxaban treatment.~   "
43577|NCT02996422|"~     Most of the nation's serious chronic health challenges and causes of death, including~     diabetes, heart disease, cancer, and obesity, are directly linked to sub-optimal diet. Both~     poor diets and associated disease are disproportionately common in the Appalachian counties~     of eastern Kentucky, a region with stark health inequities, including elevated rates of~     obesity, overweight, and premature mortality. The purpose of this study is to evaluate a~     multi-component intervention developed through community-based participatory research methods~     for improving access to healthy foods and enhancing dietary intake in eastern Kentucky. The~     intervention components evaluated in this study consist of: 1) a school-based campaign to~     promote water consumption in middle and high schools and 2) a series of group cooking classes~     for adults.~   "
43578|NCT02996409|"~     Overuse injury of the Achilles tendon is a common entity in athletes. Currently, the usual~     treatment for chronic midportion Achilles tendinopathy is an eccentric exercise program. In~     most cases this gives satisfactory results, however there is a significant group of patients~     in which the exercise program is not sufficient. Prior to our study, three United Kingdom~     based studies have investigated the efficacy of High-Volume Image-Guided Injections (HVIGI's)~     in chronic midportion Achilles tendinopathy. They all showed promising results. However none~     of these studies had an adequate control group. This double-blind, placebo-controlled,~     randomized clinical trial will investigate the value of a High-Volume Image-Guided Injection~     in chronic midportion Achilles tendinopathy.~   "
43635|NCT02995668|"~     Knee osteoarthritis is one of the most common pathologies in old people, and the leading~     cause of pain and disability. Symptoms include joint pain, stiffness, limited mobility,~     functional impairment and proprioceptive deficit. When conservative treatments fail to~     control these symptoms, a total knee replacement (TKR) is the chosen treatment, mainly~     because of its efficacy on pain relief. In recent decades, this surgical procedure has been~     soared, and it has also aroused the interest of researches about the patients' outcomes after~     surgery.~      Despite the TKR results in good reported outcomes, after surgery patients may manifest~     persistent pain and problems affecting to their functionality, stability, walking speed,~     proprioception, motor control, risk of falling and therefore to their quality of life. In~     more than a third of the cases, those deficiencies may be extended after surgery from six~     months to one year, when subjects use to achieve the plateau functional values.~      Traditional rehabilitation programs have been usually focused on improving muscle strength of~     the lower limbs as well as the functionality with specific exercises to achieve this purpose,~     and to a lesser extent on balance and proprioception exercises. Evidence supports this~     approach. Yet, task-oriented rehabilitation focusing on balance enhancement may be one of the~     most important factors for a complete rehabilitation, since benefits of proprioceptive and~     balance trainings may range from better stability and motor control, improvements in both~     static and dynamic balance and enhanced functionality. Indeed, recent studies have shown that~     the combination of traditional functional rehabilitation together with balance training may~     help to restore functional deficits to a larger extent than usual therapy, and based on a~     systematic review published (Moutzori, 2015) and in our previous works (Roig, 2016),~     sensori-motor training is an acceptable adjust to usual physiotherapy care .~      Looking into the effect of preoperative trainings or education before TKR surgery, it is~     aimed at improving the physical function, but also managing the expectations of the surgery~     for a better recovery. There is from low to moderate evidence about the effects of TKR~     pre-interventional training programs, and some authors have argued that the effects are too~     small to be consider clinically relevant.~      In general, the preoperative program is usually focused on functional and strengthening~     exercises. Despite of proprioception is used in the clinical practice for the prevention and~     recovery of many orthopedics injuries, the amount of evidence about the effects of~     proprioceptive training programs for knee and hip replacement is not large, few works~     compares pre-habilitation and post-rehabilitation programs, and there is not systematically~     reviewed evidence reporting the efficacy of balance and proprioceptive pre-interventional~     training programs.~      In this framework, this aimed at evaluating the effects of specific-task oriented~     proprioceptive and balance training programs when conducted by patients undergoing TKR before~     and after surgery, and will compare these effects to the outcomes achieved with traditional~     strength-functional programs, as well as to no specific prehabilitation training.~   "
44527|NCT02983981|"~     A two-phase, single center, study of 20 subjects to assess 4 weeks of add-on therapy of~     Topicort® BID and 12 weeks BID on two consecutive days a week to patients with ≤5% BSA who~     are receiving biologic therapy for at least 24 weeks~   "
43580|NCT02996383|"~     In England each year over 70,000 people fracture their hip. Most of these patients are~     elderly females with the fracture occurring after a simple trip or stumble. Approximately~     half of these fractures are classified from their relationship to the hip joint capsule as~     intracapsular. These fractures are subdivided into those that are displaced and those that~     are undisplaced. The majority of displaced fractures are treated with a replacement~     arthroplasty. Current treatment for the undisplaced fractures is generally by internal~     fixation of the fracture using screws and a plate, although some centres prefer replacement~     arthroplasty.~      A recent randomised study on patients from Norway with undisplaced intracapsular fractures~     treated with either internal fixation or arthroplasty has just reported reduced complications~     and re-operations for those patients treated with an arthroplasty. In addition functional~     results were marginally better for those patients treated with an arthroplasty. Current~     practice in the UK is generally to treat these fractures by internal fixation. This study~     aims to see if replacement arthroplasty can indeed lead to the advantages suggested from the~     Norwegian study.~      Patients who satisfy the inclusion criteria and are willing to participate will be randomised~     to receive either reduction and internal fixation of the fracture with a screw and plate~     device or alternatively replacement of their femoral head with an artificial hip replacement~     (hemiarthroplasty). After surgery patients will receive the same treatment as normal and be~     discharge home when able, with follow-up review in the hip fracture clinic. Subsequent~     follow-up for the research project is by phone calls from a research nurse who is blinded to~     the type of treatment that the patient has received. There will be no additional~     investigations or out-patient follow-up visits for these patients in comparison to normal~     treatment protocols. Results of the study will ultimately be published in a medical journal.~   "
43581|NCT02996370|"~     Regenerating a predictable inter-implant papilla is the most complex and challenging aspect~     of implant dentistry. The aim of the study was to compare the efficacy of I shaped incision~     technique and conventional midcrestal incision technique for interimplant papilla~     reconstruction in a 6 month clinical trial.~   "
43582|NCT02996357|"~     This study aims to identify patient characteristics associated with the development of~     Incontinence-Associated Dermatitis (IAD) category 2 (skin erosion due to incontinence).~      380 ICU patients suffering of fecal incontinence will be included in the study. Data on 19~     possible risk factors will be collected at one point in time by the research team. Different~     sources and methods will be used to collect patient data: skin assessment, patient record,~     direct patient observation, routine blood samples.~   "
43583|NCT02996344|"~     This randomized control study responds to the need for effective suicide prevention~     education/training that is grounded in adult learning theory and advances in education, in~     the context of a changing health care landscape where primary care providers are likely to~     encounter suicidal individuals. The study will test the effectiveness of suicide prevention~     education for providers-in-training by comparing two conditions: 1) A Control learning group:~     includes suicide prevention didactics (Commitment to Living: Primary Care) delivered online~     via brief videos, and 2) An Experimental learning group: includes didactics plus two~     standardized patient (SP) interactions. One Experimental learning group SP interaction will~     be in person and the other will be conducted remotely using a secure webcam service (OoVoo).~     All SP interactions will be recorded. Both groups will be compared in terms of their suicide~     prevention skills using an SP 'test case' at 6-month follow up. The primary research question~     is to learn about the impact of practice (though SP simulation) over and above didactics~     alone.~   "
43584|NCT02996331|"~     The purpose of this study is to determine whether repositioning frequency can be extended for~     nursing home (NH) residents who are low, moderate, and high risk for pressure ulcer (PrU)~     development. The investigators will also determine how changes in medical severity interact~     with changes in risk level and repositioning schedule to predict PrU development. This study~     will advance knowledge about repositioning frequency and clinically assessed PrU risk-level~     in relation to medical severity. Outcomes of this research will contribute to future~     guidelines for more precise preventive nursing practices and refinement of PrU prevention~     guidelines.~   "
43585|NCT02996318|"~     The aim of the study is to investigate the non-inferiority of the new sirolimus-coated~     balloon catheters in comparison to the paclitaxel-coated SQP with regard to acute tolerance,~     safety and efficacy in coronary DES in-stent restenosis.~   "
43586|NCT02996305|"~     The purpose of the study is to assess the safety and tolerability of oral OV101 (gaboxadol)~     in adult and adolescent subjects with Angelman syndrome. In addition, several exploratory~     efficacy outcome measures will be investigated.~   "
43587|NCT02996292|"~     This experimental study will evaluate the effect of active and passive self-ligating brackets~     in treatment of crowding, compared with the control group of conventional brackets in class I~     malocclusion without extraction.~      The study sample will consist of 66 patients with 3-6mm crowding. The sample will be~     allocated randomly into two experimental groups, in addition to a control group.~      The brackets will be applied using indirect bonding method for all patients. The~     dentoalveolar changes occurring after leveling and alignment teeth will be assessed by using~     CBCT radiographs; pre and post- treatment changes for each group will be evaluated~     individually.~   "
43588|NCT02996279|"~     Histologic chorioamnionitis (HCA) may lead to the fetal inflammatory response syndrome (FIRS)~     and increased levels of proinflammatory molecules.~   "
43589|NCT02996266|"~     This study will assess the impact of fever prevention on fever burden and short- and~     long-term neurologic outcomes in brain injured patients. Half of the subjects will undergo~     fever prevention using a targeted temperature management system and half of the subjects will~     be treated for fever should it develop.~   "
43590|NCT02996253|"~     The transfer of Flexor Hallucis Longus (FHL) in the management of chronic Achilles tendon~     ruptures has demonstrated good functional outcome, but an extensive surgical field at a~     vulnerable location may lead to increased risk for soft tissue problems. The arthroscopic FHL~     transfer may reduce the risk for soft tissue problems. Functional outcome parameters are~     investigated, wound/soft tissue complications registered.~   "
43591|NCT02996240|"~     Assess the impact of dietary omega 3 free fatty acids breast cancer patients.~   "
43592|NCT02996227|"~     Comparison of Bilateral Transversus Abdominis Plane Block with Exparel versus Continuous~     Epidural Analgesia With Bupivacaine~   "
43593|NCT02996214|"~     The purpose of this study is to investigate the efficacy and the safety of paclitaxel~     liposome injection and carboplatin compared with gemcitabine and carboplatin as first-line~     therapy in advanced squamous cell carcinoma of lung.~   "
43594|NCT02996201|"~     The aim of this study is to determine whether the use of breast cancer patients' own~     electronic reporting of side effects to chemotherapy in a treatment setting has an impact on~     the handling of side effects and on the number of hospitalizations, febrile neutropenia and~     dose adjustments. We are using the Patient-Reported Outcomes version of the Common~     Terminology Criteria for Adverse Events (PRO-CTCAE) for the patients' reporting of side~     effects.~   "
43596|NCT02996175|"~     The investigators long-term goal is to improve outcomes for children with Down syndrome (DS)~     and their caregivers. Towards that goal, the investigators propose a randomized clinical~     trial of a behavioral sleep treatment designed specifically for children with DS, documenting~     the impact not only on sleep, but also on the child's daytime inhibitory control and behavior~     problems, and the caregiver's sleep and stress levels. The investigators will randomize 80~     families of children with DS ages 6-17 to receive either a 5-session behavioral sleep~     treatment (BST; targeting sleep education, behavioral principles and visual supports) or a~     general-education control condition (CON). The BST will cater to the unique needs of children~     with DS, adapting an intervention that successfully treats behavioral sleep disturbances in~     children with autism1. Pre- and post-intervention, children will undergo comprehensive~     assessments of cognitive, behavioral, and adaptive functioning involving direct testing and~     input from parents and teachers. Child and parent sleep will be monitored via actigraphy and~     parent-completed sleep diaries, and parents will report on their stress levels and mood.~   "
43597|NCT02996162|"~     This is a prospective, longitudinal observational study to provide data regarding the natural~     course of hypercapnia in premature infants with bronchopulmonary dysplasia using both~     available blood pCO2 and measured capnography, as well as relate the degree and trend of~     hypercapnia to later respiratory outcomes.~   "
43598|NCT02996149|"~     Endoscopic lung volume reduction coil treatment is a treatment option for selected patients~     with severe emphysema. In the advanced stages, emphysema may lead to chronic hypercapnic~     respiratory failure. In this observational study the safety and efficacy of endoscopic lung~     volume reduction coil treatment in patients with chronic hypercapnic respiratory failure is~     evaluated.~   "
43599|NCT02996136|"~     The ARROW-FLU Influenza A&B Test is an in vitro diagnostic immuno-chromatographic assay~     intended for the qualitative detection of influenza A and influenza B viral nucleoprotein~     antigens from nasal or nasopharyngeal swab specimens in symptomatic patients. It is intended~     to aid in the rapid differential diagnosis of influenza A and/or B viral infections. This~     test is not intended for the detection of influenza C viruses. A negative test is presumptive~     and it is recommended these results be confirmed by cell culture of an FDA cleared molecular~     device. Negative results do not preclude influenza virus infection and should not be used as~     the sole basis for treatment or other management decisions.~   "
43600|NCT02996123|"~     measuring difference in biting force between (computer aided design/computer aided~     manufacturing) maxillary dentures and conventional ones.~   "
43601|NCT02996110|"~     The purpose of this study is to test the effectiveness and safety of various nivolumab~     combinations compared to nivolumab and ipilimumab in participants with advanced kidney cancer~   "
43602|NCT02996097|"~     The purpose of this study is to compare the effects of fractional carbon dioxide (CO2) laser~     therapy immediately followed by intralesional steroid therapy against intralesional steroid~     therapy alone for the treatment of keloids.~   "
43603|NCT02996084|"~     The primary objective of this study is to determine the normative range of brain volume and~     brain volume change in healthy control (HC) participants whose age, race, and gender~     distribution is approximately matched to the age, race, and gender distribution of patients~     with Multiple Sclerosis (MS) enrolled in Study 888MS001. The secondary objective is to use~     the results of the primary endpoint to ensure consistency of brain volume measurements across~     MS PATHS centers.~   "
43604|NCT02996071|"~     Bariatric surgery is an effective method for treatment of obesity. Sleeve gastrectomy is one~     of surgical methods and became popular in recent years. Weight loss rates after bariatric~     surgery differs among patients. The exact reason of this difference stays unclear. age,~     nationality, difference between body composition and type of surgery may be in concern. waist~     to height ratio has become popular recent years as an indicator of cardiomethabolic status.~     in this study, investigation of the effect of waist to height ratio differences of patients~     on weight loss following laparoscopic sleeve gastrectomy as a bariatric surgery.~   "
43605|NCT02996058|"~     Dexmedetomidine is a highly selective α2-agonist with hypnotic, analgesic, and anxiolytic~     properties. Despite off-label administration, dexmedetomidine has found a niche in critically~     ill mechanically ventilated neonates and infants because of its minimal effects on~     respiratory function at sedative doses, facilitating early extubation and fast-track~     postoperative care.~   "
43606|NCT02996045|"~     The goal of the study is to determine whether clinical decision support (CDS) for radiology~     affects the number, type, or appropriateness of targeted high-cost radiology imaging orders~     (i.e. magnetic resonance (MR), computed tomography (CT), nuclear medicine (NM) and Positron~     Emission Tomography (PET) scans). The CDS will be delivered to physicians in the Aurora~     Health Care system. It will be delivered in Epic, an industry-standard electronic medical~     record software, through ACR Select, which is a leading decision support tool based on the~     American College of Radiology (ACR) Appropriateness Criteria (see~     http://www.acr.org/Quality-Safety/Appropriateness-Criteria). The ACR Select tool rates~     imaging orders on a scale of 1-9 with 1-3 labelled as 'usually not appropriate', 4-6 'May be~     appropriate', and 7-9 'usually appropriate'.~   "
43607|NCT02996032|"~     This is a study to determine if two ultrasound measures (Corrected Flow Time and B-Lines) can~     predict patients at higher risk of readmission within 30 days of hospital discharge for~     decompensated heart failure.~   "
43608|NCT02996019|"~     This is a randomized, 2-part, 2-arm, open-label, parallel-group, multi-center study to~     compare the PK of etrolizumab administered subcutaneously by an AI (test device) or a PFS-NSD~     (reference device) in healthy participants. The study will comprise a pilot cohort (Part 1)~     to estimate the geometric mean ratio (GMR) and variability of the maximum observed~     concentration (Cmax) and area under the concentration-time curve (AUC) to confirm or~     determine the sample size for the pivotal cohort (Part 2). The pivotal cohort will~     demonstrate exposure comparability of Cmax, AUC from Hour 0 to the last measurable~     concentration (AUClast), and AUC from Hour 0 to extrapolated infinite time (AUC0-inf), values~     for a single dose of etrolizumab administered subcutaneously either by the AI or the PFS-NSD.~   "
43609|NCT02996006|"~     This observational study introduced an new advanced bleeding control strategy during complex~     liver resection.This newly described stepwise vascular control technique was efficacious~     and feasible to control intra-operative bleeding in complex hepatectomy involving second~     hepatic hilum and retro-hepatic inferior vena cava.~   "
43612|NCT02995967|"~     The specific aim of this trial is to determine if hydrodistention at the time of~     intradetrusor injection of botulinum toxin A has additional benefit in patients with~     refractory overactive bladder (OAB) and urgency symptoms compared to intradetrusor injection~     of botulinum toxin A alone.~      Consented patients will be randomized to hydrodistention at a pressure of 80 cm H2O for 5~     minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A~     (hydrodistention group) or intradetrusor injection of 100 units of botulinum toxin A alone~     (botulinum toxin A alone group).~      The primary aim will be subjective improvement measured as change from baseline at 12 weeks~     using the OAB-q bother subscale.~   "
43613|NCT02995954|"~     The introduction of fixed combination of ACEi+CCB (Fixed) has significantly increased~     patients compliance and adherence to therapy. At the moment, however, there are no data~     suggesting the better control of once-daily fixed (Fixed) over free doses in separate~     administrations combination therapy in hypertensives.~      In a population of 39 consecutive outpatient patients referred to the departmental~     Hypertension clinic of the University Hospital of Salerno Medical School with the first~     diagnosis of arterial hypertension, the investigators tested the hypothesis that the Fixed~     achieve a better control of blood pressure than the Free combination. Patients were~     randomized to either strategy and after 3 months patients underwent a clinical assessment to~     evaluate the antihypertensive effect.~   "
43614|NCT02995941|"~     The purpose of this study is to examine the reliability and use of the shoulder symptom~     irritability classification system for the purposes of determining an appropriate treatment~     intensity to better help people with shoulder pain.~   "
43615|NCT02995928|"~     Decompressive craniectomy has been reported for the treatment of patients with aneurysmal~     subarachnoid hemorrhage (aSAH). But no prospective randomised controlled trials have yet been~     undertaken to confirm its effect.The purpose of the study is to determine whether~     decompressive craniectomy combine aneurysm clipping surgery or endovascular coiling will~     improve clinical outcomes of poor-grade aSAH patients.~   "
43616|NCT02995915|"~     Alcohol misuse and smoking constitute two of the three leading preventable causes of death in~     the United States. The purpose of this research study is to develop an intervention designed~     to help people stop drinking alcohol and stop smoking at the same time.~   "
43617|NCT02995902|"~     The purpose of the study is to determine the value of FLT-PET early after initiated~     chemotherapy in patients with small cell lung cancer, and to determine whether MRI of the~     brain should be performed routinely in these patients.~   "
43618|NCT02995889|"~     This study investigates the feasibility of FLT-PET to improve the diagnosis of relapse in~     patients with irradiated lung cancer in comparison with FDG-PET/CT.~   "
43619|NCT02995876|"~     When missing tooth structure or teeth are replaced, minimal biologic risk should be involved~     to re-establish function and esthetics. The increased use of the adhesive technique and~     preservation of dental tissues have greatly impacted conservative tooth preparation design.~     The development use of zirconia technology and all-ceramic systems has opened the potential~     for fabrication inlays zirconia bridges with durability and good aesthetics.~      The purpose of this study is to clinically evaluate the placement of inlay bridge made of a~     Y-TZP framework veneered with a pressed ceramic and bonded with a completely adhesive~     approach in the replacement of a single missing tooth.~   "
43620|NCT02995863|"~     This research presents a randomized clinical trial which analyzes the efficacy of a rigid~     rocker sole in the reduction of the recurrence rate of plantar ulcers in diabetic foot~     patients. The hypothesis of the research is the use of a rigid rocker sole reduces the~     recurrence rate of diabetic foot ulcers in patients with peripheral neuropathy.~   "
43621|NCT02995850|"~     This is an open-label, non-randomized, single-center, phase Ib/II study, evaluating efficacy~     and feasibility of cytoreductive surgery(CRS), extensive peritoneal lavage, hyperthermic~     intraperitoneal chemotherapy(HIPEC) and post-operative intraperitoneal chemotherapy~     combination in gastric cancer with peritoneal metastasis~   "
43622|NCT02995837|"~     Obstructive sleep apnea syndrome (OSAS) causes hypoxemia and hypercapnia, which may impair~     cerebral blood flow and cause deficits in behavior. This is a case-control study designed to~     investigate cerebral blood flow and neurocognitive function in children with OSAS when~     compared to these findings from normal children. The study hypothesis is that children with~     OSAS have an impaired cerebral blood flow during wakefulness and sleep compared to normal~     controls, and that the degree of this impairment correlates with neurocognitive function.~   "
43623|NCT02995824|"~     This is a retrospective observational multicenter cohort study based on 271 consecutive~     HIV-HCV coinfected patients who underwent liver transplantation (LT) between 2002 and 2012 in~     23 centers from Spain and who were prospectively followed until January 2016. The main~     objective of this study is to analyze the effectiveness and safety of 2 nucleoside reverse~     transcriptase inhibitors (NRTIs) plus Raltegravir (RAL)- based antiretroviral therapy (ART)~     compared to other antiretroviral regimens in liver transplant (LT) HIV-HCV co-infected~     recipients. In addition, the investigators want to know the rejection rates in patients~     taking RAL-based ART in comparison with other ART-regimens and to know the efficacy and~     safety of direct antiviral agents (DAAs) against HCV in HIV-infected liver transplant~     recipients taking RAL-based ART.~   "
43624|NCT02995811|"~     This study will identify the changes in different muscles of patients receiving~     Extracorporeal Membrane Oxygenation (ECMO) during critical illness and admission to Intensive~     Care Unit (ICU). The information will help guide development of treatments such as exercise~     that may help to reduce the amount of muscle wasting that can occur during critical illness.~   "
43646|NCT02995512|"~     The aim of this study is to determine the immuno-modulatory mechanistic effects of colchicine~     in patients with myocardial infarction (MI). Investigators hypothesize that colchicine exerts~     its anti-inflammatory properties by switching the metabolism of neutrophils, thereby reducing~     the expression of adhesion molecules responsible for their recruitment in MI.~   "
43647|NCT02995499|"~     The ASA-PS classification, a subjective classification system of the patients' preoperative~     health status, contains a certain problem concerning its interrater reliability. A comparison~     between anesthesiologic and surgical assessment of the preoperative patient condition has not~     yet been extensively investigated. The aim of this study is to examine the latter in a~     prospective, monocentric, observational study.~   "
43625|NCT02995798|"~     Data of CT images and the femoral neck BMD were obtained from 99 patients who underwent the~     cervical CT and BMD simultaneously (the gap of both studies was within 6 months) from April~     2009 to December 2014. There were 52 females and 47 males. The mean age was 63.7 year~     (female: 63.4 years, male: 64.1; range 32-86 years). The patient was excluded who had any~     destructive pathology or severe spondylosis in the cervical pedicle and the cervical lateral~     mass. Patients were divided into three groups according to femoral neck BMD (Group A, T-score~     ≥-1; Group B, -2.5<T-score<-1.0; Group C, T-score≤-2.5). Group A had normal BMD patients,~     Group B had lower normal patients including osteopenic patients and Group C presented~     osteoporotic patients. The mean HU numbers of cortical bone area in the vertebral canal (cHU,~     the medial wall of the lateral mass), the posterior wall of transverse foramen (fHU), the~     medial (mHU), lateral wall (lHU) and trabecular area of pedicle (pHU) were measured on the~     axial CT images in clinical images.~   "
43626|NCT02995785|"~     [Background and Objective]First-aid skill training plays an important role in the education~     of nurses. How to implement stable and efficient skill is very important. (Kardong-Edgren,~     Oermann, Odom-Maryon, & Ha, 2010). Simulation-based workshops,or training, as the most common~     enhancing skills.(Topping et al., 2015) .This study was designed to assist nurses enhancing~     the clinical ability and safety the patients in the first aid-related skills and knowledge.~     The purpose of this study is to compare the two groups of(1) first aid knowledge online test.~     (2) first aid skills test.【Methods】This study is a general ward nurses first aid technical~     examination, pre-test and post-test, the random control trial. Review by the hospital ethics~     committee and execution date on105/12/12-107/03/08, a total of 92 cases, obtained consent of~     all cases, then the case will be test in our hospital clinical skills center. Subject~     condition: general ward nurse (minimum age> 20 years),exclusion conditions: intensive care~     unit nurses, emergency department nurses. Study Procedure: Subjects who obtained the informed~     consent were randomly assigned to the first aid skill simulation training group (FAST) or the~     traditional group (T) by using a computer generated number. Randomization envelopes were~     opened and randomization performed by the study nurse after informed consent was obtained.~     Each group consisted of 46 subjects. All the subjects were pre-test first aid knowledge~     online test, followed were pre-test first aid skills test at the Clinical Skills Center.After~     pre-test,the experimental group are give the first aid skill simulation training with~     debriefing(75-min) and online lecture(15-min).While the traditional group only give online~     lecture(15-min). Two weeks later, the post-test include online test and skills test for two~     groups. After all the data were collected by the researchers who unknown the groups, the~     names of the cases were removed and the scores of the two groups were compared before and~     after.The test Based on 2015 AHA Guidelines for CPR & ECC (2015 Adult Basic Life Support and~     Cardiopulmonary Resuscitation Quality & 2015American Heart Association and 2015).The data~     will be archived in SPSS20.0 statistical package software. Statistical methods such as T-test~     and Anova variance analysis are used to analyze the data【Expected Result】: The knowledge and~     skills in the experimental group were better than the traditional group, and the first-aid~     simulation skill training was helpful for the clinical emergency situations.~   "
43627|NCT02995772|"~     This study compared long term outcome of stage IIIB/C and IV breast cancer patients treated~     with neoadjuvant hormonal therapy (NAHT) and those treated with neoadjuvant chemotherapy~     (NACT)~   "
43628|NCT02995759|"~     Data strongly suggests that aggressive and early treatment of status epilepticus (SE) is~     crucial for seizure abortion and prevention of long-term neurologic sequelae. We propose the~     creation of a seizure action plan, an intervention aimed to guide daily medication use,~     outline pre-hospital seizure first aid and rescue medication use, and direct emergency~     personnel in patients' individualized SE medication algorithm, with implementation through~     the electronic medical record. We hypothesize that the seizure action plan will promote daily~     medication adherence, increase use of home rescue mediation, and improve timeliness of AED~     (antiepileptic drug) delivery, length of hospital stay, and ICU admission rate in episodes of~     status epilepticus.~   "
43629|NCT02995746|"~     This study seeks to evaluate the effect of the intravitreal 0.7mg dexamethasone implant on~     central macular thickness and visual acuity in those patients with persistent macular edema~     after pars plana vitrectomy for epiretinal membrane.~   "
43630|NCT02995733|"~     Asthma imposes a significant burden in the US in terms of morbidity, costs to society,~     individual suffering, loss of productivity and mortality. African Americans (AA) and~     Hispanic/Latinos (H/L) bear a disproportionate share of that morbidity. Despite national~     guidelines for asthma treatment, the gap between these groups and whites has been stable or~     widening. The need for pragmatic research to address the continuing burden is widely~     recognized. Patients use asthma reliever inhalers to provide immediate relief of symptoms.~     Controller inhalers (inhaled corticosteroids (ICS)) are intended to be used regularly to~     prevent symptoms and attacks. Guidelines suggest that they be used daily, on a fixed basis,~     in all but the mildest asthma. However, adherence by patients and implementation of~     evidence-based guideline recommendations by clinicians has been poor. Gap analysis suggests~     that it is difficult to improve adherence to the current recommendations without complex and~     resource-intensive interventions. Studies have examined symptom-activated use of ICS~     triggered by use of a reliever medication. The Investigators call this approach PARTICS -~     Patient Activated Reliever-Triggered Inhaled CorticoSteroid. Explanatory, non-real world~     studies suggest that PARTICS can produce up to 50% reductions in asthma attacks compared with~     usual care, while reducing ICS use by half or more. These studies have been performed in~     pre-selected populations, which represent less than 5% of asthma patients. The previous~     studies have been done with repeated education and adherence checks in both the intervention~     and control arms.~      The investigators have consulted with AA and H/L patients, health care providers, leaders of~     professional societies, advocacy groups, health policy leaders, pharmacists, and~     pharmaceutical manufacturers. All groups have indicated that asthma decision making would be~     changed if we demonstrated that implementing PARTICS improves important asthma outcomes such~     as reducing exacerbations. The Investigators have designed a study with the stakeholders to~     determine whether PARTICS can improve outcomes that are important to patients when~     superimposed on a background provider-educated standard of care through the Asthma IQ system.~     The Investigators propose a study entitled PREPARE: Patient Empowered Strategy to Reduce~     Asthma Morbidity in Highly Impacted Populations. The Investigators aim to determine whether~     PARTICS can reduce asthma morbidity in AA and H/L.~   "
43631|NCT02995720|"~     An open-label, randomized, single-dose, 2X3X3 partial replicate, crossover study to compare~     the pharmacokinetics and safety between a fixed dose combination of~     Fimasartan/Amlodipine/Rosuvastatin and Co-administration of a fixed dose combination of~     Fimasartan/Amlodipine and Rosuvastatin in healthy male subjects.~   "
43632|NCT02995707|"~     This is an exploratory experiment, aims to explore the effective and safety of thalidomide in~     the treatment of NTDT to improve the hemoglobin level, improve the quality of life, reduce~     blood transfusion, so as to avoid the adverse reactions caused by transfusion.15~30 patients~     will be enrolled, including type α 5~13 cases, type β 10~17 cases.~   "
43633|NCT02995694|"~     The purpose of this study is to determine the therapeutic equivalence of Alvogen's estradiol~     vaginal cream to Estrace® cream and superiority of both products to placebo. The protocol~     describes a randomized, double-blind, multi-dose, placebo-controlled, parallel study of a 7~     day treatment.~   "
43634|NCT02995681|"~     People living with Chronic Obstructive Pulmonary Disease (COPD) have problems with their~     balance and a high incidence of falls compared to those of a similar age. Pulmonary~     rehabilitation is recommended for people with COPD, however, these training programs do not~     typically include balance training or fall prevention strategies. In this study, patients~     with COPD who report problems with their balance or have had a fall in the last two years~     will be assigned to a treatment group (balance training plus pulmonary rehabilitation) or~     control group (standard pulmonary rehabilitation). We will record the number of falls using~     monthly diaries and evaluate patient's balance, strength, confidence and quality of life.~   "
43636|NCT02995655|"~     The investigators hypothesize that CX-01 will disrupt the bone marrow microenvironment and~     increase the cytotoxic effects of azacitidine on myelodysplastic syndrome (MDS) and acute~     myeloid leukemia (AML) hematopoietic stem cells by disrupting the High-mobility group box~     protein 1 (HMGB1) interaction with toll-like receptor 4 (TLR4) and receptors for advanced~     glycation end products (RAGE), the CXC chemokine CXCL12/chemokine receptor 4 (CXCR4) axis,~     and by disrupting other leukocyte and vascular adhesion molecules. In addition, CX-01 may~     also help promote count recovery after treatment given its affinity for platelet factor-4~     (PF4).~      The selection of CX-01 dose for study in relapsed or refractory MDS and AML has been based~     upon the dual requirements to have sufficient drug administered to have potential activity~     but without clinically significant anticoagulation. The study dose chosen (4 mg/kg bolus~     followed by 0.25 mg/kg/hour) fulfills both of these criteria. In addition, this dose is~     expected to result in serum levels of CX-01 which are significantly higher than the IC90~     identified in preclinical studies for inhibition of HMGB1-RAGE, toll-like receptor 2 (TLR2)~     and TLR4 interaction. Therefore, the chosen dose represents a rational balance between~     effective dosing and safety in thrombocytopenic patients with MDS and AML. This dose was~     previously established to be safe and tolerable when combined with cytarabine and idarubicin~     in patients with AML.~   "
43637|NCT02995642|"~     Stroke and abdominal aortic aneurysms (AAAs) are common and highly lethal vascular diseases.~     Angiogenesis and infiltration of inflammatory cells such as macrophages may cause stroke and~     AAAs.~      The purpose of this study is to test PET/CT and PET/MRI imaging to specifically detect those~     diseases using a new developed agent (18F-FPPRGD2) that can target angiogenesis and~     macrophages.~   "
43638|NCT02995629|"~     Our aim is to compare patient comfort when using the 532 nanometer (green) wavelength laser~     to the 577 nanometer (yellow) wavelength laser during pan retinal photocoagulation to treat~     patients with diabetic retinopathy. Secondary outcome measures will be power (mW) required to~     achieve gray-white retinal burns and duration of treatment.~   "
43639|NCT02995616|"~     The aim of this study will be to investigate the energy consumption, cardiorespiratory load~     and perceived exertion in non-ambulatory subacute stroke patients during a robot-assisted~     gait training (RAGT) session and to compare the exercise intensity with aerobic training~     recommendations.~      The second aim is to investigate the effect of different levels of guidance force on the~     energy consumption, cardiorespiratory load and perceived exertion.~   "
43640|NCT02995590|"~     Recently, the investigators have demonstrated a novel hyperpolarized helium tagging Magnetic~     Resonance Image (MRI) technique that is capable of directly, in vivo, and non-invasively~     measuring physiological lung deformation on a regional basis. This unique imaging technique~     holds great promise for assessing, validating, and improving the use of Deformable image~     Registration (DIR) algorithms in the lung. Our long term aim is to apply hyperpolarized gas~     tagging MRI to study lung biomechanics, develop more physiologically sound DIR algorithms for~     the lungs, and eventually improve radiotherapy of lung cancer. The overall aim of this~     application is to optimize the hyperpolarized helium tagging MRI technology and establish its~     usefulness for DIR assessment.~      Our first objective is to develop and optimize a methodology based on 3 Dimensional (3D)~     hyperpolarized helium tagging MRI of healthy subjects, for directly measuring lung~     deformation between inhalation and exhalation. Our second objective is to develop~     physiologically sound digital thorax phantoms based on helium-3 tagging MRI of healthy~     subjects and demonstrate their use for DIR assessment in the lung. These phantoms will be~     used to evaluate a range different DIR algorithms, by comparing the errors between the~     DIR-derived deformation vector fields and the ground truth represented in the digital~     phantom. Successful completion of these aims will yield a novel methodology for DIR~     assessment in the lung for radiotherapy.~   "
43641|NCT02995577|"~     The purpose of this study is to investigates serum and stool biomarkers as predictors for~     post-operative feeding intolerance in infant patients with complex congenital heart defects~     who undergo single ventricle staged palliation surgery.~   "
43642|NCT02995564|"~     This study is investigating the development of a social skills training program for adults~     with Asperger's Syndrome or high-functioning autism, ages 18 to 35 years. The Principal~     Investigator for this study is Dr. Michael Murray, the director of the Autism Studies~     Division at the Penn State Hershey Medical Center. The purpose of this study is to adapt a~     social skills training program to address and enhance the social skills of adults with~     Asperger's Syndrome and high-functioning autism.~   "
43643|NCT02995551|"~     There are two cartilage structures in each knee joint called a meniscus. A torn meniscus can~     be caused by either a smaller or larger trauma or be a degenerative age-related tear.~     Arthroscopic meniscal surgery is the most common orthopedic procedure, but no high-quality~     studies have investigated the efficacy of meniscal surgery for younger patients (i.e. 40~     years or younger) in comparison to non-surgical treatments.~      The purpose of this study is to determine if a strategy of early arthroscopic meniscal~     surgery (repair or resection) is superior to a strategy of initial individualized supervised~     exercise therapy including patient education with the option of later surgery if needed in~     improving pain, function and quality of life in young patients (18-40 years) with meniscal~     tears.~      The hypothesis is that patients treated with early arthroscopic meniscal surgery will improve~     more than patients treated with exercise and education.~   "
43644|NCT02995538|"~     The objective of this project is to develop a Neurogenetics patient database and bio~     repository - which includes clinical information regarding history, physical examination,~     laboratory testing including genetic testing (NextGen sequencing including whole exome and~     whole genome sequencing, SNParray, etc.), neuroradiology studies, neurophysiology studies -~     all ordered as clinically deemed appropriate, natural history from clinical longitudinal~     follow-up and to use de-identified information from this registry/ repository, when~     appropriate for clinical and translational research.~   "
43645|NCT02995525|"~     The aim of this epidemiologic prospective study is to determine the prevalence of CPSP~     defined as pain occurring 4 months after scoliosis and thoracic surgery and rated > 3 on a 10~     point visual analogue scale or FLACC scale, in children aged from 6 to 18 years.~      The main objective : prevalence of chronic post surgical pain 4 months after scoliosis ant~     thoracic surgery in children aged 6 to 18 years.~      The secondary objectives: the intensity of chronic post surgical pain, the prevalence of~     neuropathic syndrome and the predictive risk factors.~   "
43648|NCT02995486|"~     A randomized, control trial will be conducted to evaluate the effects of a post-discharge~     falls prevention program in patients with neurological diseases and disorders. The objective~     of this study is to evaluate if implementing a falls prevention program is effective in~     reducing subsequent falls and re-hospitalizations, and improving gait, strength and balance~     in older adults after hospital discharge. Patients from Baptist Health Neuroscience Center~     will be randomized on the day of discharge to receive an exercise falls prevention program,~     delivered by Baptist Health physical therapists, or an educational pamphlet on falls~     prevention. Baseline and follow up assessments for gait, balance, and strength will be~     completed at regular intervals to examine effects of the exercise program. In addition,~     participants will be surveyed to find out about recent falls and hospitalizations. This is a~     minimal risk study such that the assessments involve conditions in which subjects likely~     encounter on a daily basis. The risks of the exercise intervention also are no more than one~     might expect from a community exercise program. Potential benefits include reduced~     hospitalizations and/or emergency visits related to falls in the intervention group,~     increased activity levels and improved falls efficacy in the intervention group, and~     increased system capacity at Baptist Health to deliver a falls prevention program.~   "
43649|NCT02995473|"~     This study is to evaluate the efficacy and safety of topical application of NP000888 ointment~     compared to vehicle in plaque and fingernail psoriasis subjects.~      Duration of administration: 24 weeks~   "
43650|NCT02995460|"~     Psoriatic arthritis is a chronical inflammatory disease characterized by pain and reduced~     physical function. Patients have a higher risk of cardiovascular disease and a higher body~     mass index.~      A pilot study in patients with rheumatoid arthritis has shown positive effect on inflammation~     after 12 weeks of high-intensity interval training.~      The primary aim of this study is to determine whether high-intensity interval training~     affects the disease activity in psoriatic arthritis. This intervention is believed to result~     in benefits in terms of inflammation, body composition and risk factors for cardiovascular~     disease.~   "
43651|NCT02995447|"~     The anesthetic propofol has a dose-depending effect on the EEG, which differs in comparison~     between scalp and intracerebral electrodes~   "
43652|NCT02995434|"~     This study seeks to explore the efficacy of virtual reality (VR) experiences as a practical~     adjunctive therapeutic intervention in the self-management of the chronic pain associated~     with cancer patients. A comparative controlled interventional trial and qualitative~     interpretative-descriptive exploration will be undertaken with 100 cancer patients who are~     experiencing chronic pain. Participants will be randomly assigned to either a virtual~     reality(VR) therapy group or an immersive multimedia control group (50 subjects in each).~      They will undertake either a series of virtual reality interventions, or 2D multimedia~     control sessions in their own homes over a period of a month. The intervention will be used~     daily for a month to enable customization to the therapy and record data over a long enough~     period of time to account for any individual short-term changes in pain.~      The VR sessions will consist of using a VR head mounted display (HMD) and computer to explore~     interactive immersive environments. The control group will be exposed to similar 2D computer~     based multimedia experiences (without a VR headset) that on home computers. Pre, during, and~     post pain test scores and quality of sleep assessments will be recorded using standardized~     tools.~      At the end of the study, ten of the subjects who demonstrated the most improvement in their~     pain using the VR experience will be selected and invited to explore for any measurable~     changes in neurological activity using pre and post exposure MRI studies.~   "
43653|NCT02995408|"~     This study has three aims:~      Phase I: Through focus group interviews with expert clinicians, leaders of organizations, and~     parents with children with ASD, this study aims to identify the psychosocial needs of parents~     of children with ASD, specifically a) the types of concerns that parents find most difficult~     and stressful b) areas of concern that lack support and resources, and c) areas of need for~     education and skill training. This study also aims to gather feedback on the Benson-Henry~     Institute's Relaxation Response Resiliency Program (3RP).~      Phase II: Informed by Phase I findings, this study aims to develop and determine the~     feasibility and acceptability of a virtual 8-session Relaxation Response Resiliency (3RP)~     program for parents of children with ASD.~      Phase II: This study also aims to test the effectiveness of a pilot wait-list control trial,~     establishing efficacy of a virtual resiliency program.~   "
43654|NCT02995395|"~     This study will evaluate the role the balloon mucosal impedance may have in diagnosing and~     monitoring the patients with Eosinophilic Esophagitis. We will compare the results of the~     balloon mucosal impedance in patients with Eosinophilic esophagitis and controls.~   "
43655|NCT02995382|"~     This study aims to determine the Health Related Quality of life (HRQOL) (the physical,~     mental, emotional and social functioning) of patients with cubital tunnel syndrome following~     anterior intramuscular transposition, after one year.~   "
43656|NCT02995369|"~     The goals of this study are to determine if 1) placement times of pit and fissure sealants~     using the DryShield system differ from those when using the cotton roll isolation technique;~     and 2) there is a significant difference in patient preference between Dryshield and the~     cotton roll technique.~   "
43657|NCT02995356|"~     Patients who have doubt for ectopic pregnancy will be enrolled for our study. These patients~     will be determined with using irregular increased human chorionic gonadotropin (beta-HCG)~     results and no embryo reported ultrasonography results. Plasma and cervical fluid samples~     will be taken from these patients and axonemal dynein heavy chain 5 and creatine kinase~     levels of samples will be compared between patients who have doubt for ectopic pregnancy and~     patients who have intrauterine pregnancy. Concentration of these proteins in samples will be~     evaluated. If any difference will be found between groups in favour of ectopic pregnancy,~     these results might be interpreted as these proteins useful for early detecting of the~     ectopic pregnancy.~   "
43671|NCT02995174|"~     Contrast balanced dichoptic videogame training has been found to improve sensory functions in~     adults with amblyopia; best corrected distance visual acuity (BCVA) and stereopsis, but its~     effect on motor function, namely amblyopic eye fixation stability, is unknown. Furthermore,~     the effect of treatment in cases of mild amblyopia is not well understood. The aim of this~     study is to find out the difference on fixation stability, BCVA and stereopsis in mild~     amblyopes after 6 weeks' contrast balanced dichoptic video game training.~   "
43672|NCT02995161|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
43658|NCT02995343|"~     Patients who hypogastric arteries and/or uterine arteries had been ligated will be evaluated~     in terms of ovarian reserve markers such as anti-mullerian hormone levels, ovarian volumes,~     antral follicule count, follicule stimuli hormone and estrogen levels. Investigators will~     search their archives for finding suitable patients for study. Investigators will especially~     notice being at least 6 month time of interval between surgery and evaluation time.~     Ultrasound examination and taking blood sample will be performed on 2nd or 3th day of~     menstrual cycle. These results will be compared with normal postpartum women's results. It~     will be evaluated that there is or not any effect of the hypogastric arteries and/or uterine~     arteries on ovarian reserve~   "
43659|NCT02995330|"~     Men with progressive metastatic Castration-Resistant Prostate Cancer post first-line~     treatment with either androgen deprivation therapy alone or androgen deprivation therapy plus~     docetaxel who have an identified related female donor (mother sister, daughter, second degree~     relative such as granddaughter or niece) will undergo bone marrow transplantation followed by~     post-transplant Cytoxan (PT/Cy) and testosterone.~   "
43660|NCT02995317|"~     The purpose of this study is to investigate if the level of physical activity, selected~     physical and psychological risk factors can predict risk of falling in older (≥65) community~     dwellers.~   "
43661|NCT02995304|"~     In this double blind study, after taking an informed consent, 60 children aged between 7 and~     12 years old assigned for tonsillectomy with or without adenoidectomy will be randomly~     divided into three groups. The first group 30 children will receive 0.025 mg/kg midazolam IV~     followed by 0.1 mg/kg morphine as a premedication 20 to 30 min before surgical incision. In~     the second group30 children who will receive the same dose of midazolam followed by saline~     premedication. All groups will be compared for pain score using visual analog scale (VAS)~     after recovery and hourly for 8 hours and during first drinking. Heart rate (HR), blood~     pressure and peripheral oxygen saturation (SPO2) will be recorded before premedication, every~     10 min after premedication then every 5 min during and after anesthesia. 6 point sedation~     score and 4 points behavioral score will be monitored every 5 min after sedation. Four-point~     wake-up score will be recorded every 5 min. Time of first analgesic requirement and total~     morphine consumption during the first post-operative 8 hours will be recorded.~   "
43662|NCT02995291|"~     Clinical trials have shown phentolamine mesylate (PM), brand name OraVerse, to be effective~     at reducing the amount of time to reversal of local anesthesia with different dental~     anesthetics. However, to date no study investigated the efficacy of phentolamine mesylate to~     reverse anesthesia induced with the use of Bupivacaine.~      The objective of the proposed research is to conduct a pilot-scale randomized clinical trial~     evaluating the difference in time required for the return of normal soft-tissue sensation and~     function in participants who have received 0.5% Bupivacaine HCl, 1:200,000 epinephrine,~     followed by an injection with either 1) OraVerse (phentolamine mesylate) or 2) sterile~     physiological water (control).~   "
43663|NCT02995278|"~     The purpose of this minimal risk, observational survey is to document the accuracy, benefits,~     and how qualitative and quantitative results affect patients' plan of care.~   "
43664|NCT02995265|"~     To determine the effect of using a robotic exoskeleton to allow walking practice after~     stroke, compared to usual physiotherapy care, on recovery of walking ability and secondary~     outcomes.~   "
43665|NCT02995252|"~     This is an observational, longitudinal, prospective study for sample collection and~     evaluation for future therapy or disease progression of chronic hepatitis B and C.~     Participants will be seen on an annual basis with optional additional visits for up to 10~     years and provide samples for research and evaluation of disease progression. In addition,~     there is a longitudinal sub-study for treatment of hepatitis B that will involve 2 years of~     treatment with tenofovir alafenamide and blood collections with optional liver biopsies.~   "
43666|NCT02995239|"~     To compare the pharmacokinetics after administration of different formulation of CJ-12420~   "
43667|NCT02995226|"~     The purpose of this study is to check if patients, but also relatives (as they share familial~     and genetic risk factors), are having more difficulties in regulating a spontaneous, pleasant~     physical effort (doing too much) compared to healthy controls, and if physical efforts are~     participating to core symptoms of anorexia nervosa, such as more appetite (instead of less),~     less pain, more abnormal body image, and less cognitive flexibility.~      Such a result could help to further understand the role of difficulties with physical~     exercise as part of the phenotype of anorexia nervosa.~   "
43668|NCT02995213|"~     The investigators are proposing a pilot study, the purpose of which is to use accelerometers~     to quantify UE use (1 and two hand use) in people post-stroke from which the investigators~     will develop use-based feedback to improve recovery in the home setting. The objectives of~     this pilot study are to:~      i.) determine the feasibility of using accelerometers to quantify amount of UE use in the~     home setting in individuals chronic post-stroke,~      ii.) quantify and compare the unilateral activity of the weaker (paretic) versus stronger~     (non-paretic) UEs, and~      iii.) assess the effect of a 7 sessions of in-home accelerometer used-based feedback on~     unilateral and bilateral UE use.~      iv.) assess kinematic, kinetic, and EMG data during UE movements unilaterally and bilaterally~     in subjects post-chronic stroke pre and post feedback.~   "
43669|NCT02995200|"~     A pilot study, the purpose of which is to use accelerometers to quantify UE use (1 and two~     hand use) in healthy controls and people post-stroke from which the investigators will~     develop use-based feedback to improve recovery in the home setting. The objectives of this~     pilot study are to:~      i.) determine the feasibility of using accelerometers to quantify amount of UE use in the~     home setting in healthy individuals and individuals chronic post-stroke,~      ii.) quantify and compare the unilateral activity of the weaker (paretic) versus stronger~     (non-paretic) UEs,~      iii.) quantify and compare amount of UE use in healthy controls to that of people chronic~     post-stroke (side matched unimanual use for each arm and bilateral use) in the home, and~      iv.) assess the effect of a few sessions of in-home accelerometer used-based feedback on~     unilateral and bilateral UE use.~      v.) assess kinematic, kinetic, and EMG data during UE movements bilaterally and between~     healthy controls and subjects post-chronic stroke pre and post feedback (for the people after~     stroke).~   "
43670|NCT02995187|"~     This is a Single-center, Open-label, Single-arm,Non-randomized exploratory clinical trial~     evaluating the efficacy and safety of Apatinib for third-line and later treatment of patients~     with small cell lung cancer.~   "
43677|NCT02995096|"~     Recurrence after liver transplantation for hepatocellular carcinoma (HCC) represents an~     important cause of mortality for this surgical population. In addition to tumor~     characteristics, It has been suggested that pre-treatment and sirolimus-based~     immunosuppression may affect recurrence and survival. With data from the European Liver~     Transplant Registry (ELTR) database, the aim of this study is to investigate the impact of~     tumor characteristics, pre-transplant treatment and immunosuppression regimens on survival~     after liver transplantation for HCC.~   "
43678|NCT02995083|"~     To investigate the clinical benefit of intra-articular injections of saline in patients with~     symptomatic osteoarthritis of the knee and compare the clinical response of saline to the~     current standard treatment with corticosteroids and an air injection placebo.~   "
43679|NCT02995070|"~     The aim of this study is to evaluate the influence of therapy with low-intensity laser~     technique associated with connective tissue graft for root coverage in smokers and compare~     the results with non- smokers~   "
43680|NCT02995057|"~     Hypodermic needles are conventionally used to deliver drugs and vaccines into the muscle of~     humans and animals. Side effects of these needle injections are pain, bleeding, and anxiety~     in patients. An alternative drug and vaccine delivery method is the use of hollow~     microneedles, which are sub-millimeter needle-like structures. Microneedles are pain- and~     bleeding-free, as they do not reach the nerve-endings and blood capillaries in the skin. As a~     result, they are better received by patients and do not induce needle anxiety. As the~     investigators' microneedles are made of gold- or silver-coated, as well as uncoated nickel,~     the purpose of this study is to observe their biocompatibility and inertness.~   "
43681|NCT02995044|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
43682|NCT02995031|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
43683|NCT02995018|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
43684|NCT02995005|"~     Mother-to-child transmission (MTCT) of hepatitis B virus (HBV) remains the major mode of~     transmission in most high and intermediate HBV endemic areas, despite existing WHO~     immunoprophylaxis recommendations. This immunoprophylaxis regimen, if given optimally, can~     prevent 75-80% of HBV MTCT, but optimal implementation is difficult because it requires~     administering monovalent HBV vaccine and hepatitis B immunoglobulin (HBIg) within 24 hours of~     birth. Due to the barriers of giving HBIg, the World Health Organization (WHO) states,~     …owing to concerns related to supply, safety and cost, the use of HBIg is not feasible in~     most settings. Clearly, global control of HBV transmission will require improved MTCT~     prevention. Therefore, the investigators hypothesize that treating HBV early in pregnancy~     will lead to undetectable HBV DNA levels at delivery and prevention of MTCT of HBV without~     HBIg; a concept that has already been proven with HIV. Tenofovir disoproxil fumarate (TDF),~     an approved anti-HBV drug, is promising to prevent MTCT of HBV due to its high potency~     against hepatitis B and its safety record in pregnant women. A randomized, controlled~     clinical trial (RCT) will be necessary to determine if TDF given to HBV-infected pregnant~     women early in pregnancy plus vaccine to the newborn can decrease MTCT of HBV without HBIg.~     However, before embarking on a RCT, several critical knowledge gaps need to be addressed~     including the ideal timing for TDF initiation. The purpose of this proposal is to address~     these knowledge gaps.~   "
43685|NCT02994992|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
43686|NCT02994979|"~     Delirium is an acute confusion that occurs in one third of hospitalized older adults. As~     compared to those without delirium, hospitalized patients with delirium have longer hospital~     stays, higher mortality, and increased risk of nursing home utilization. Substantial~     attention has been paid to developing, testing, and disseminating interventions to prevent~     delirium in the hospital but, to date, not in the nursing home setting. In a previous study~     we used known information on delirium risk factors to develop an intervention that can be~     delivered at onset of acute illness in nursing home patients. The current study is designed~     to test the effect of this intervention in a single-site clinical trial. Objectives: 1) to~     determine, as compared to control, the effect of a multicomponent intervention targeting~     delirium risk factors on delirium frequency, delirium severity, cognitive and physical~     function decline, and hospitalization in nursing home patients with acute illness, and 2) to~     identify features of the intervention associated with occurrence of delirium and other~     outcomes. Approach: We will screen nursing home patients on 17 long-term care units at a~     large, urban nursing home who experience onset of a change in condition according to~     established criteria, and enroll and assign them to intervention or control in a 1:1 ratio.~     Those assigned to intervention will receive daily visits from an Elder Life Specialist, a~     mobile Certified Nursing Assistant trained to provide services to counter risks for delirium,~     including dehydration, immobility, cognitive impairment, undernutrition, and sleep problems,~     for the duration of the acute illness and for 1 week following. Patients assigned to control~     will receive usual care from the unit-based nurses and the patient's primary team. Delirium~     will be assessed 5 days a week by a research assistant. Cognitive and physical function~     decline and hospital transfer will be ascertained during a 1 month follow-up period. We will~     compare outcomes between intervention and control, as well as examine associations between~     outcomes and intervention features such as number and duration of visits.~   "
43687|NCT02994966|"~     In 2011, the premiers of all Canadian provinces and territories selected diabetes foot care~     as one of three significant targets for pan-provincial action. The Diabetes Foot Care~     Clinical Pathway Project (DFCCPP) aims to optimize methods of early detection and treatment~     of foot ulcers in an effort to reduce lower limb amputation (LLA) by 50%. The DFCCPP key~     deliverables apply consistency in assessment, care, treatment and process standards, early~     intervention and complex wound care management, while optimizing health outcomes. To achieve~     these deliverables, High Risk Foot Teams (HRFTs) will be implemented across the province~     starting with three pilot sites (Slave Lake, Brooks, and outpatient clinics at the Peter~     Lougheed Hospital). The pilot site facilities were selected on the basis of their employing~     staff with expertise and knowledge in diabetic foot care. The HRFT will assess and treat~     patients with moderate and high-risk findings, and this care pathway will then be rolled out~     to all clinicians who perform diabetic foot assessments (Primary Care, Home Care, Diabetes~     Centers, First Nations Reserves, etc.). In conjunction with the DFCCPP, we will evaluate the~     efficacy of a technological device developed by Alberta-based small-medium enterprise (SME)~     to improve diabetic foot outcomes by preventing future wounds in high-risk patients who have~     recently been treated for active foot ulcers. This technology is the SurroSense Rx® smart~     insole system (Orpyx Medical Technologies Inc., Calgary AB), a device that provides dynamic~     offloading guidance to patients, in addition to enabling ongoing adherence tracking by the~     HRFT. It is hypothesized that early wound detection and treatment will ultimately lead to~     improvements in wound prevalence, chronic wound care, and reduce the need for surgical~     intervention, including LLA.~   "
45697|NCT02968719|"~     A Phase 1, Randomized, Open-Label, 3-Way Crossover, Pilot, Pharmacokinetic Study to Evaluate~     the Steady State Pharmacokinetics of a Once-Weekly Application of Corplex Donepezil~     Transdermal Delivery System (TDS) Compared to Daily Oral Administration of Aricept in Healthy~     Adult Subjects~   "
43688|NCT02994953|"~     The study consists of 2 parts: Dose Escalation phase (Part A) and Expansion phase (Part B).~     The dose escalation phase will evaluate the safety, tolerability, and PK of avelumab in~     combination with NHS-IL12 in subjects with locally advanced, unresectable, or metastatic~     solid tumors. Expansion phase will assess the safety and clinical activity of the combination~     regimen in selected tumor types. In Expansion phase subjects who have completed the~     combination treatment of avelumab at a given dose level of NHS-IL12, a safety review will be~     performed by the Safety monitoring committee in order to make a decision on the next dose~     level. Successive cohorts of 3 to 6 subjects will be treated with escalating doses of~     NHS-IL12 with avelumab intravenous (IV).~   "
43689|NCT02994940|"~     Acetaminophen is frequently used as an adjunct for pain management in pediatric surgical~     patients. The drug is available in an over the counter, inexpensive oral form as well as a~     considerably more expensive intravenous form. This study will compare opioid requirements and~     acetaminophen plasma levels post operatively for two dosing regimens to compare oral versus~     intravenous routes given pre operatively.~   "
43690|NCT02994927|"~     The aim of the trial is to assess the safety and efficacy of the orally-administered,~     selective complement C5a receptor inhibitor CCX168 (avacopan) in inducing and sustaining~     remission in patients with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis~     (AAV).~   "
43691|NCT02994914|"~     This study proposes an onco geriatric evaluation (Activities of Daily Living, Instrumental~     Activities Of Daily Living, Mini Mental State Examination, mini Geriatric Depression Scale,~     Mini Nutritional Assessment, Cumulative Illness Rating Scale-Geriatric, and  timed get up~     and go  tests) for elderly breast cancer patients. The score obtained at this evaluation~     will determine the radiotherapy scheme.~   "
43692|NCT02994901|"~     The goal of this cross-sectional study is to evaluate the difference in cytokine profiling~     approach and mitochondrial function between geriatric sarcopenic patients (group 1) and~     geriatric non-sarcopenic patients (group 2) and healthy (group 3) geriatric participants.~   "
43693|NCT02994888|"~     PROSPECT-C is a phase II study investigating the molecular markers of response or resistance~     to anti-epidermal growth factor receptor (EGFR) antibodies.~   "
43694|NCT02994875|"~     The objective of this research is to identify the functional neural mechanisms (as assessed~     using fMRI) of short-term N-acetylcysteine (NAC) administration among methadone-maintained~     individuals with cocaine dependence.~   "
43695|NCT02994862|"~     In teeth requiring laminate veneers with amelogenesis imperfecta Will application of galla~     chinensis before Bonding of laminate veneers with adhesive resin cement provide better~     survival rate than conventional Bonding method~   "
43696|NCT02994849|"~     Premature babies, born several weeks before their due date, are often very ill in the first~     weeks and months of life, compared with those born at full term. Because babies' brains and~     bodies are still developing at this time, early birth puts them at increased risk of later~     problems with health and development. It is important to do everything possible to try to~     improve the overall health of these children. Not only will this help children and families,~     but it will also help to understand the correct amount and type of care they will need from~     the NHS in the future. At present, England has three types of neonatal units: Neonatal~     Intensive care units (NICUs) that can care for the most sick and most premature babies, Local~     Neonatal Units (LNUs) that generally care for slightly less sick babies, and Special Care~     baby units (SCBU) that care for larger premature babies who are generally well, but need time~     to grow and develop before going home.~      For those premature babies born between 27 and 31 weeks of pregnancy, there is no information~     on whether they benefit from being looked after in one type of unit or another. At present~     there is no guidance, so these babies may be looked after in either LNUs or NICUs. Babies who~     are born at this stage of pregnancy cannot be looked after in a SCBU and sometimes need to be~     moved after birth to either a NICU or LNU. There are 84 LNUs and 45 NICUs in England. In~     2014, about half of these babies were cared for in a NICU and half in a LNU. There is the~     need to know whether babies born between 27 and 31 weeks are best cared for in a NICU or LNU~     or if it does not matter.~      The main things that control where a baby is born are where the mother has her antenatal~     care, and where there is a cot available for the baby. A mother may have antenatal care in a~     hospital that has a NICU, LNU or SCBU. Because it is difficult to predict which mother is~     going to have her baby early, she cannot be directed, at the time of her choosing her~     hospital for antenatal care, where to go to for care. There is uncertainty before birth which~     baby is likely to require intensive care, but usually the less mature babies need more~     intensive care.~      In this study to find out where it is best to care for babies born at 27-31 weeks of~     pregnancy, the study will look at which type of unit: a) leads to the best outcome for babies~     born at each week of pregnancy in this range; b) is most cost-effective for families and the~     NHS and c) best considers views and needs of parents and staff caring for babies.~   "
43697|NCT02994836|"~     This study will be a multicentre prospective randomized trial to assess the percentage of~     patients with IBD who, after stopping anti-TNF treatment, have sustained clinical remission~     at one year compared to those in which the treatment is continued at stable doses~   "
43698|NCT02994823|"~     The investigators compared a pooled mother's expressed breastmilk for 24 hours with~     individual pump session collection of milk to provide a more consistent caloric product~     without increasing bacterial contamination.~   "
43699|NCT02994810|"~     The benefits of breastfeeding are increasingly known of the population and breastfeeding~     rates in the country have been increasing, but still are below satisfactory to the Ministry~     of Health (MH) and the World Health Organization (WHO).~      Simple Strategies to guide and support the mother contributes to increasing knowledge about~     breastfeeding and can have positive impacts on breastfeeding rates.~   "
43700|NCT02994797|"~     Ultrasonography in salivary gland has demonstrated its usefulness to diagnose and follow~     patients with Sjögren syndrome (pSS). More recently, a new imaging technique allows to study~     the parenchymal elasticity in salivary glands and could be a new tool to evaluate patients~     with sicca syndrome and pSS.~   "
43701|NCT02994784|"~     This is a single arm, open label study designed to evaluate the safety and efficacy of~     propylene glycol-free melphalan hydrochloride in patients with AL amyloidosis. Treatment will~     be comprised of propylene glycol-free melphalan hydrochloride administered intravenously at a~     dose of 70-100 mg/m2/day on Days -3 and -2 as conditioning prior to autologous stem cell~     transplantation.~   "
43702|NCT02994771|"~     Indicated for the Treatment of Secondary Lymphedema Associated with the Treatment of Breast~     Cancer.~      Primary objective is to evaluate the safety and tolerability of a single dose of Lymfactin®~     in patients with secondary lymphedema associated with the treatment of breast cancer.~   "
43703|NCT02994758|"~     The purpose of the study is to evaluate whether state-of-the-art technologies such and next~     generation sequencing and drug sensitivity and resistance testing of patient derived tumour~     tissue can facilitate research translation and improve outcome of urologic cancers.~   "
43704|NCT02994745|"~     The purpose of this study is to evaluate the Pharmacokinetics and Safety / Tolerability of~     Fimasartan and Atorvastatin in Healthy Male volunteers.~   "
43707|NCT02994706|"~     Cystic fibrosis (CF) is the most common fatal inherited condition in Caucasians, causing~     recurrent chest infections and premature death due to lung failure. When patients develop~     chest infections their symptoms usually slowly worsen over the course of several days to~     weeks. Due to this gradual onset, patients often seek medical attention several days or weeks~     after symptoms start to worsen. The Investigators believe that if they were able to monitor~     patients more closely they could diagnose and treat chest infections earlier and consequently~     improve health outcomes.~      The HOMECF study aims to investigate whether home monitoring is beneficial for adults with~     CF. 100 subjects will be randomly allocated, 50 to receive home monitoring and 50 to receive~     routine clinical care for 12 months. Subjects receiving home monitoring will measure their~     lung function and symptoms twice weekly and this data will be transmitted to the medical team~     by means of a modified mobile phone.~      the Investigators hypothesize that home monitoring will allow them to diagnose chest~     infections at an earlier stage and reduce hospital inpatient days. They will also assess the~     subjects' experience of receiving home monitoring, the impact on body weight and lung~     function and and conduct a full health economic analysis to assess value for money. They will~     also ask subjects to collect a urine sample once weekly to allow us to measure urinary levels~     of inflammatory markers.~      Subjects will be recruited at the West Midlands Adult CF Centre in Birmingham. The research~     team are well placed to carry out the study because it is a large regional adult CF centre~     with an excellent record of conducting clinical research.~   "
43708|NCT02994693|"~     The goal of this research is to determine the natural history of Barrett's esophagus (BE)~     using tethered capsule endomicroscopy (TCE) in patients undergoing surveillance endoscopy.~   "
43709|NCT02994680|"~     The purpose of this randomized controlled field trial is to determine whether a liquefied~     petroleum gas (LPG) stove and fuel distribution intervention reduces personal and kitchen~     exposure to household air pollutants and improves cardiopulmonary health outcomes when~     compared to usual cooking practices with open-fire biomass-burning stoves in adult women aged~     25-64 years.~   "
43710|NCT02994667|"~     The purpose of this study is to assess the incidence (at 90-days) of ventricular pacing in~     patients undergoing permanent pacemaker placement after TAVR.~      As well as incidence (at 90-days) of atrioventricular block (AVB), intraventricular~     conduction delay (IVCD), bundle branch block (BBB), and rate histogram in patients undergoing~     permanent pacemaker placement after TAVR.~   "
43711|NCT02994654|"~     The overall purpose of this is study to provide continued access to the ReCell device~     following completion of protocol CTP001-6, and allow for collection of supplementary clinical~     outcome data for the ReCell device when used as an adjunct to meshed grafts in subjects with~     acute thermal burn injuries who require skin grafting for closure of burn injuries.~   "
43712|NCT02994641|"~     In the surgical intensive care unit (SICU), goals of critical care are often discussed in~     long-term ventilated patients around the time of extubation. Muscle weakness predicts~     extubation failure but formal muscle strength assessment by the Medical Research Council~     scale is time-consuming and not part of the daily clinical exam. In this observational study,~     we hypothesize that COMA measurement, routinely used by the SICU nurses, is a reliable and~     valid predictor for patients' SICU outcomes. This prospective observational study is carried~     out within a consecutively enrolled cohort of adult patients who are extubated in two SICUs~     at Massachusetts General Hospital, Boston.~   "
43713|NCT02994628|"~     In a previous study at the Appalachian State University (ASU) Human Performance Laboratory at~     the North Carolina Research Campus (NCRC), investigators showed that cyclists ingesting about~     one-half of a banana with water every 15 minutes cycled 75-km faster (5%) than with water~     alone. The polyphenols (i.e., chemicals in plants with health benefits) in the banana~     improved the capacity to counter oxidative stress, and the sugars lowered post-exercise~     inflammation. The cyclists reported some gastrointestinal discomfort, however, from the high~     volume of bananas consumed. Dole Foods, the sponsor of this study, has a banana collection~     that includes many different varieties, including the Mini banana that has a higher sugar~     (50%) and phenolic (63%) content than the typical banana (Cavendish) available in stores.~     Thus athletes should experience similar performance benefits from a smaller volume of Mini~     compared to Cavendish bananas, and reduced gastrointestinal symptoms. If study results are~     favorable, Dole Foods may market the Mini banana as the sport banana.~      The purpose of this study is to compare ingestion of Mini and Cavendish bananas with an~     equicaloric, sugar-only beverage or water on 75-km cycling performance and post-exercise~     oxidative capacity and stress, inflammation, immune function, muscle damage and soreness, and~     gastrointestinal symptoms.~   "
43714|NCT02994615|"~     Patients with hypertrophic cardiomyopathy are being compared to a control group. IMR will be~     assessed with a pressure wire. Clinical f/u at 3 months and 6 months and a 48 hour holter~     monitor.~   "
43715|NCT02994602|"~     This is a two-center, open-label study conducted in healthy male and female volunteers at two~     academic research centers. The study will consist of three single applications of the~     Nestorone (NES) + testosterone (T) combined gel on the shoulders/upper arms of male~     participants followed 2 hours later by supervised skin contact by the non-dosed female~     participants on the application site on days 1, 8, and 15. Effect of Washing or Clothing~     Barrier to the Application will be assessed.~   "
43716|NCT02994589|"~     The investigators objective is to compare OASIS wound matrix with other commonly used~     dressings available for the donor site in split thickness skin grafting in order to determine~     which dressing provides the best outcome based on pain level, time to healing and aesthetic~     outcome.~   "
43736|NCT02994329|"~     This cluster randomised trial aims to evaluate the impact of a pilot HIVST intervention of~     oral HIV self-testing (HIVST) as an option for HIV testing, in addition to the offer of~     home-based rapid HIV testing, through community health workers (CHW) on knowledge of HIV~     status among the general adult and adolescent population.~      The primary outcome of the trial is the proportion of individuals who know their HIV status,~     defined as a self-report of being HIV positive or accepting testing (standard or self~     testing) from the CHW.~      Embedded within the impact evaluation is a process evaluation that will explore the fidelity~     of the implementation of the intervention and outputs of the intervention. Qualitative data~     on actual use, management and disposal of the HIVST kits, acceptability of HIVST and any~     impacts on relationships (including between couples and with CHW) associated with use of~     HIVST kits.~   "
43717|NCT02994576|"~     Based on the efficacy of immunotherapies in advanced disease with a reasonable safety~     profile/tolerability we could hypothetisize that, immunotherapy should work best in the~     situation of minimal residual disease, Two clinical trials are ongoing to test the role of~     immunotherapeutic agents in the adjuvant setting: PEARLS trial, a randomized phase III trial~     with anti-PD1 monoclonal antibody pembrolizumab (MK-3475 or pembrolizumab) versus placebo for~     patients with early stage NSCLC after resection and completion of standard adjuvant therapy,~     and the second randomized phase III trial (NCT02273375) will evaluate the efficacy of an~     anti-PD-L1 (MEDI 4736) for a maximum of 12 months versus placebo as adjuvant therapy in~     completed resected stage IB-IIIA NSCLC and completed standard ACT.~      The role of immunotherapeutic approaches for NSCLC in the neoadjuvant setting is currently~     unknown. However, based on the survival efficacy of immunotherapeutic strategies in advanced~     NSCLC where the tumor has not been removed which could produce higher immunogenicity and~     based on the efficacy of neoadjuvant treatments in NSCLC, we propose to test the safety and~     efficacy of atezolizumab as neoadjuvant therapy in subjects diagnosed with stage IB, II, or~     IIIA (non N2) NSCLC and who are deemed suitable for surgical resection.~      Clinical staging of NSCLC is based on computed tomography (CT) of the chest and upper~     abdomen, brain CT or magnetic resonance imaging and 18F-FDG PETscan to rule out metastatic~     disease and assess the potential for curative-intent resection. Adjuvant chemotherapy will be~     performed according the standard clinical guidelines.~   "
43718|NCT02994563|"~     Prospective, single-arm, open label, Safety and Performance clinical investigation.~   "
43719|NCT02994550|"~     The aim of this study is to compare different FSH/LH ratios in controlled ovarian stimulation~   "
43720|NCT02994537|"~     The purpose of this study is to explore the pathogenes, clinical characteristics, laboratory~     and histological examination results, treatment and prognosis of autoimmune hepatitis(AIH).~     At phase 1, the investigators focus on studying of the clinical characteristics of acute~     autoimmune hepatitis, and then will study the difference about treatment effects between~     acute autoimmune hepatitis and chronic AIH. Morever, the investigators have noticed that drug~     induced AIH have some special characteristics that may be beneficial to distinguish it with~     durg induced liver disease. Therefore the investigators will do some studies about drug~     induced AIH or other disease which maybe related to the onset of AIH.~   "
43721|NCT02994524|"~     .Rerouting operation takes the advantage of minimal recurrence rate as well as minimal~     incontinence that is associated with less sphincter division,It is indicated in patients with~     transsphincteric fistula in whom lay open is expected to be associated with significant~     incontinence .~   "
43722|NCT02994511|"~     This study will explore the potential of the circulating tumour DNA (ctDNA) as predictive~     factor of response/resistance to anticancer treatment. The project will involve the~     collection and study of the archived tumour tissue where available (mandatory), serial blood~     samples (mandatory) and fresh tumour biopsies (optional) from patients taking part in an~     early phase clinical trial.~   "
43723|NCT02994498|"~     The primary study objectives are~        1. to evaluate the safety and tolerability profiles of DCB-BO1301 and to determine the~          maximum tolerated dose (MTD) of DCB-BO1301 as add-on therapy to dacarbazine in subjects~          with advanced melanoma (Phase I)~        2. to evaluate the efficacy profile of DCB-BO1301 at MTD or lower dose level as add-on~          therapy to dacarbazine in subjects with advanced melanoma in terms of progression free~          survival (Phase IIa)~   "
43724|NCT02994485|"~     Portal hypertension is not a disease in itself. Rather, it is an indication of an illness,~     caused mostly by chronic lesions of the liver because of distinct causes, such as viral~     infection, chronic alcoholism, or metabolic disorders. Other reasons include splanchnic~     vascular diseases (for example, obstruction of the portal or the hepatic veins). Portal~     hypertension is defined as a pressure in the portal vein exceeding the vena cava pressure by~     more than 5 mm Hg.~   "
43725|NCT02994472|"~     The Investigators institution has used a meal consisting of mashed potato, peas and Beanfeast~     (soya mince) for gastric emptying studies for a number of decades. Validation of the study~     method was purportedly performed when the study was first implemented at the hospital,~     however no historical data has been found. The current normal ranges are also~     unsubstantiated. There is scientific justification for this research because in vivo studies~     are instrumental to the validation of a new procedure. There is a need for a meal preparation~     that is palatable and meets dietary requirements (vegetarian, gluten free e.t.c.) of patients~     as the diagnosis depends on ingestion of the radiolabelled meal. In addition, reliable normal~     ranges will ensure that the clinical diagnosis is accurate. Scientific justification extends~     beyond the local department as publishing the data acquired will allow other hospitals to~     adopt the same test meals and normal ranges, leading to standardisation of the clinical~     protocol employed across the UK. Since the investigators institution are recognised as the~     leading Nuclear Medicine GI centre in the UK and have previously carried out audits and in~     vitro testing in the area of gastric emptying, it seems fit that they should lead the~     national change in protocol.~      The proposed study will involve recruitment of healthy volunteers who will eat a meal~     containing 10MBq of a radioactive tracer. They will be subsequently scanned using a gamma~     camera with imaging lasting no more than 3 hours in total. Approximately 40 healthy~     volunteers (18-70 years old, no history of gastrointestinal problems or other serious health~     issues e.g. diabetes and pregnant women are excluded) will be recruited and the studies will~     be conducted on site i.e. within the Nuclear Medicine department at City hospital.~   "
43737|NCT02994316|"~     Children with diabetic ketoacidosis risk neurological complications such as cerebral edema~     with high morbidity. To prevent cerebral edema, it is essential to control correction of~     hypovolemia, hyperglycemia and natremia. Markers usually used in management of diabetic~     ketoacidosis don't always permit an optimal care.~      Plasma copeptin levels reflect vasopressin secretion which is high in diabetic ketoacidosis.~      Therefore, monitoring of plasma copeptin levels could be of interest in children with~     diabetic ketoacidosis and risk of sévère neurological complications.~   "
43841|NCT02992964|"~     This is an open-label, single arm, multi-center, pilot study of Nivolumab in pediatric~     patients with recurrent or refractory hypermutant malignancies aged 12 months to 18 years of~     age. This study is to assess clinical and radiological benefits of treatment with Nivolumab~     in children with hypermutated cancers, including those with bMMRD syndrome. It is our~     expectation that patients with bMMRD syndrome will account for the majority of patients~     enrolled on this study.~   "
43726|NCT02994459|"~     People who are obese often have insulin resistance (inability of insulin to properly control~     blood sugar) and high blood sugar. However, not all people with obesity have this problem.~     About one third of people with obesity have normal sugar metabolism (the way your body uses~     sugar). The reasons why some people with obesity have a problem with blood sugar control and~     others do not are not entirely clear. It is thought that impaired muscle sugar uptake is the~     main problem related to high blood sugar in people with obesity. However, adipose tissue (fat~     tissue) also consumes a substantial amount of blood sugar. Therefore, it is unclear whether~     muscle or adipose tissue (fat tissue) are primarily responsible for altered blood sugar~     concentrations in persons with metabolically abnormal obesity (MAO) (those with insulin~     resistance and high blood sugar), compared to those with metabolically normal (healthy)~     obesity (MNO), or whether healthy adipose tissue (fat tissue) expansion in MNO people~     compared with lean people provides a vessel for blood sugar removal that helps maintain~     normal blood sugar concentration.~      Accordingly, the investigators will determine the amount of sugar that is taken up by the~     body and in the cells of adipose tissue (fat tissue) and muscle by infusing labeled sugar~     into the blood and looking at its disappearance from blood and appearance in adipose tissue~     (fat tissue) and muscle. The investigators will also determine how well insulin, a hormone~     that controls blood sugar, turns on signals that stimulate sugar uptake in fat and muscle~     cells. These studies will be done after an overnight fast and during an infusion of sugar and~     insulin (hyperinsulinemic-euglycemic clamp), in sex- and age-matched MNO and MAO people and a~     group of sex- and age-matched healthy lean people.~   "
43727|NCT02994446|"~     The purpose of this study is to demonstrate the technical feasibility of the SERF Catheter~     and SERF Cardiac Ablation System to eliminate or control ventricular tachycardia (VT)~   "
43728|NCT02994433|"~     Most clinical major depression responds to standard treatments (medication and~     psychotherapy); however, a significant subset of depressed patients (15-20%) do not respond~     to these treatments and are referred to as treatment-resistant major depression (TRMD). New~     treatments for TRMD are needed, and one promising line of research are drugs known as~     N-methyl-D-aspartate (NMDA) glutamate receptor antagonists. In a recent pilot study, our~     group demonstrated that the NMDA antagonist nitrous oxide is effective in TRMD. This~     application proposes to take the next important step in understanding how nitrous oxide~     exerts its effects in the human brain by using state-of-the-art brain neuroimaging~     (functional connectivity magnetic resonance imaging) in a group of non-depressed, healthy~     volunteers and comparing the results to a group of TRMD patients.~      This study involves exposing 20 non-depressed healthy participants and 20 TRMD participants~     to nitrous oxide and a placebo gas, to compare their brain images before and after each of~     the inhalation sessions. Sessions will be separated by at least one month to prevent~     treatment effects from carrying over into the following session. All willing and eligible~     subjects will undergo up to six functional connectivity MRI scans, and two inhalation~     sessions. Functional imaging in the brain will allow us to trace the interconnections between~     various parts of the brain, including those involved with emotion and depression.~      Other procedures will involve screening materials to ensure safety of the participants before~     beginning the study (i.e. no MRI scan contraindications) and that subjects meet eligibility~     criteria to being in the targeted age range, depression/non-depressed state, neurological~     disorder history, and no medication exclusions.~   "
43729|NCT02994420|"~     The purpose of this study is to better understand how female sex hormones influence the food~     intake in the gut system through the release of satiety hormones as well as through central~     regulative mechanisms in the brain that subsequently contribute to the control of eating in~     healthy women at different stages of the ovarian cycle.~   "
43730|NCT02994407|"~     The trial is conducted in Asia, Europe and North America. The aim of the study is to evaluate~     the safety of administration under the skin of turoctocog alfa pegol (SC N8-GP) in patients~     with severe haemophilia A.~   "
43731|NCT02994394|"~     To assess the bioequivalence of OPC-41061 OD tablets and OPC-41061 conventional tablets at 15~     and 30 mg in healthy adult male subjects.~   "
43732|NCT02994381|"~     This will be an open-label, non-randomized, single oral dose study in healthy male subjects.~      All subjects will receive a single oral dose of 10 mL of [14C]-RPC1063 Solution (0.1 mg/mL),~     containing NMT 1.3 MBq (37 μCi) 14C.~   "
43733|NCT02994368|"~     The purpose of this study is to understand the rate of progression of all stages of~     choroideremia using a variety of assessments performed in the clinic including visual field~     measures, specialized photography of the eye and participant-reported visual problems~   "
43734|NCT02994355|"~     Location: Family Planning Clinics in Mombasa County, Kenya~      Introduction:~      Integration of HIV treatment and prevention with family planning (FP) services is a promising~     approach for optimizing delivery of comprehensive healthcare for HIV-positive women, as well~     as prevention services for those who are negative. In Mombasa County, the USAID-supported~     AIDS Population and Health Integrated Assistance II Program revised the FP Clinic Register to~     capture HIV testing in 2008. However, the rate of HIV testing in FP clinics remains low. Our~     overarching objective is to assess the effectiveness, costs, and budget impact of~     implementing the systems analysis and improvement approach (SAIA) to increase HIV testing in~     FP clinics in Mombasa County.~      Methods:~      The investigators aim to conduct a cluster-randomized trial comparing the effect of the SAIA~     approach versus usual procedures on rates of HIV testing in first-time attendees at 20~     intervention versus 20 control FP clinics in Mombasa County. The investigators will compare~     HIV testing rates for first-time FP clinic attendees in SAIA intervention versus control~     facilities after an additional year, during which FP clinics in the intervention arm will be~     encouraged to continue to use the SAIA tools with minimal support from the study team as the~     Mombasa County Ministry of Health will take ownership of implementation. Lastly, the~     investigators aim to estimate the incremental cost and budget impact of applying SAIA versus~     standard of care using an activity-based approach.~      Anticipated Results:~      The investigators anticipate that SAIA will produce significant and sustained improvement in~     HIV-testing rates in first-time FP clinic attendees in intervention clinics compared to~     control facilities. The use of a rigorous study design will provide strong evidence to guide~     integration of HIV testing into FP services in a wide range of settings. The inclusion of~     costing and budget impact analyses will assist policy makers in reaching informed decisions~     about implementation.~      Anticipated Conclusion:~      By addressing the crucial first step in the linkage of HIV and FP services, this research~     holds considerable promise for improving women's health by opening the gateway to HIV care~     and prevention.~   "
43735|NCT02994342|"~     Evaluation of ZP-025 vaginal gel in terms of efficacy and safety in the treatment of vaginal~     dryness in post-menopausal women with vaginal atrophy in comparison to a group of non-treated~     post-menopausal women with vaginal atrophy after 56 consecutive days and at 4-week follow-up~     only for women applying ZP-025 vaginal gel.~   "
43788|NCT02993653|"~     Definitive treatment protocol for high-dose intensity-modulated radiotherapy (IMRT) with~     intracavitary radiotherapy in locally advanced cervical cancer: A phase II trial~   "
43789|NCT02993640|"~     The purpose of this study is to determine if vasopressin and nitroglycerin in combination~     will affect hepatic hemodynamics, in the setting of liver surgery.~   "
43738|NCT02994303|"~     In patients with Fabry disease, this research study explores the presence of podocytes in~     their urine as a potential non-invasive biomarker for baseline kidney disease; and explores~     changes in the quantity of podocytes in their urine over time as a predictor for kidney~     disease progression. To accomplish this, the investigators will evaluate the quantification~     of podocytes in the urine of Fabry disease patients at baseline and longitudinally over time.~     This study requires a single patient visit, during which the patient provides a urine~     specimen. The research team will then collect the patient's kidney function data proximate to~     the time of urine collection, and follow the patient's kidney function data longitudinally~     over the five years of this study by reviewing their medical charts. The study offers no~     interventions.~   "
43739|NCT02994290|"~     The purpose of the proposed pilot study is to assess the implementation of IPP-HPV~     immunization at Yale New Haven Hospital (YNHH) and to identify potential barriers to and~     facilitators of this intervention to optimize its feasibility and effectiveness. It is~     imperative that innovative interventions be developed to achieve comprehensive utilization of~     this highly effective vaccine to reduce rates of HPV infection, lower rates of cervical and~     other HPV associated cancers, and address cancer disparities.~   "
43740|NCT02994277|"~     The purpose of this study is to use closed-loop systems with the algorithms designed by the~     University of Virginia and by the Instituto Tecnologico de Buenos Aires (ITBA)/ Universidad~     Nacional de La Plata (UNLP)/ Universidad Nacional de Quilmes (UNQ) to determine the infusion~     of insulin in a prolonged period of time in patients with type 1 diabetes mellitus (T1DM).~   "
43741|NCT02994264|"~     The aim of the study is to retrospectively evaluate the outcome of adjuvant concurrent~     chemoradiation delivered to patients with high grade non-metastatic soft tissue sarcomas of~     the extremities at the investigators institution paired with patients treated by adjuvant~     radiation therapy~   "
43742|NCT02994251|"~     The study will be a single-center, single-arm, Phase II study of gemcitabine and cisplatin in~     combination with conventional trans-arterial chemoembolization therapy in adult patients with~     advanced ICC. 25 patients will be enrolled over the course of 2 years, with an additional 1.5~     years for patient follow-up.~   "
43743|NCT02994238|"~     The goal of this study is to determine whether a sensor-enabled, clinically integrated,~     mobile health asthma program can improve asthma outcomes among 4-11 year old children with~     moderate-to-severe asthma.~   "
43744|NCT02994225|"~     The initial standard treatment of breast cancer is surgery. Tumor involvement of lymph nodes~     is of paramount importance in the subsequent management of this cancer and surgery of~     invasive breast cancer involves axillary lymph node dissection (ALND). To preserve arm~     lymphatic drainage during ALND and avoid the risk of arm lymphedema, mapping the lymphatic~     drainage by axillary reverse mapping (ARM) has been developed. But oncological safety is~     uncertain.~      The ARM procedure presented here uses indocyanine green (ICG) and fluorescence detection of~     draining lymphatics. The project aims to train surgeons to the technique and to identify~     predictive factors for metastatic ARM nodes in invasive BC using tumor and axillary~     pathological parameters to better select patients who would not require removal of the ARM~     node in the future~   "
43745|NCT02994212|"~     Community-based management of severe acute malnutrition (SAM) has been shown to be safe and~     cost-effective, but program coverage remains low. New treatment models that maintain high~     levels of clinical effectiveness but allow for increased coverage are still needed. A reduced~     schedule of follow-up, in which children receive clinical follow-up and therapeutic foods on~     a monthly rather than weekly or biweekly basis, may be one alternative. This study aims to~     describe the safety and feasibility of a monthly distribution of ready-to-use therapeutic~     food in the treatment of uncomplicated SAM, in terms of clinical response to treatment and~     household ready-to-use therapeutic food (RUTF) utilization. This is a non-randomized pilot~     intervention study in which 115 children eligible for the outpatient treatment of SAM were~     provided a monthly ration of RUTF. Anthropometric measurements were taken on a weekly basis~     for 4 weeks to monitor treatment response defined as weight gain, (mid-upper arm~     circumference) MUAC gain, weight loss > 5%, and the development of edema. Unannounced~     household spot checks were conducted over 4 weeks to assess household utilization of RUTF and~     storage practices.~   "
43746|NCT02994199|"~     The purpose of this study is to compare the effectiveness of off-the-shelf (OTS) and adapted~     game controllers on quality of game play, enjoyment, and energy expenditure during active~     video gaming in persons with mobility impairments. The controllers to be evaluated include~     off-the-shelf and adapted gaming mats and off-the-shelf and adapted Wii Fit balance boards.~   "
43747|NCT02994186|"~     Bariatric surgery is the most effective, long-term treatment for morbid obesity, and~     consistent with previous findings, individuals who lose significant weight after surgery also~     have improved cognition or brain function. The mechanisms behind these cognitive~     improvements are currently unknown, but are the focus of much research effort. The goal of~     this pilot study is to thoroughly describe these changes in surgical versus medical weight~     loss patients over time in a repeated measures fashion.~   "
43748|NCT02994173|"~     To study the multimodal protocol combining adjunct ketamine with oxycodone in intravenous~     patient-controlled analgesia bolus dosing and effects in patients scheduled for~     posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation~   "
43749|NCT02994160|"~     Our goal is to temporarily implant the following groups for 90 days:~        1. Three human partial hand amputees (amputated at the level of the hand) with 2 FAST-LIFE~          electrodes, one inserted into the motor fascicle of the ulnar nerve and the other into~          the sensory fascicle.~        2. Five human hand and forearm amputees (amputated at the level of the forearm) with 2~          FAST-LIFE electrodes in the ulnar nerve (one in the motor fascicle, one in the sensory~          fascicle) and 4-5 FAST-LIFE electrodes in the median nerve (one in the motor fascicle,~          one in each of the 3-4 sensory fascicles).~   "
43790|NCT02993627|"~     In this double-blind Randomized Controlled Clinical Trial investigators are going to study~     the effects of Spirulina supplementation on anthropometric measurements, lipid profile,~     appetite, liver enzymes, inflammatory and glycemic markers in a sample of overweight or obese~     adults.~   "
45698|NCT02968706|"~     The purpose of this study is to investigate if high flow nasal cannula (HFNC), as compared to~     conventional nasal cannula, improves oxygenation and prevents desaturation events in obese~     patients undergoing colonoscopy.~   "
43750|NCT02994147|"~     Repeated joint bleeding leads to hemophilic arthropathy (HA), which manifests with chronic~     synovitis, cartilage damage and bony destruction. Currently available treatments of HA,~     including analgesics, NSAIDs, and hyaluronic acid, are predominantly directed toward the~     symptomatic relief of pain and inflammation, with no or little effect on joint cartilage~     degeneration. AC201CR, a control released formulation of AC-201, demonstrates~     anti-inflammatory effects by reducing NLRP3 inflammasome assembly. AC-201 is also unique in~     that it influences both the anabolism and catabolism of chondrocytes in vitro and has shown~     cartilage-sparing properties in animal studies. The study is designed to evaluate the joint~     structure-modifying and symptom-relieving effects, safety, and tolerability of AC-201CR in~     subjects with HA.~   "
43751|NCT02994134|"~     The overall goal of the proposed study is to compare the effects of 4 weeks of moderate or~     high intensity aerobic exercise on neuroplasticity, cognitive performance and gait and~     postural control in sedentary healthy adults.~   "
43752|NCT02994121|"~     In this longitudinal prospective natural history study of multiple sclerosis (MS), the~     overarching goal is to understand the factors that influence individual variation in disease~     trajectory and treatment response and pave the way for realizing precision medicine in MS.~     Because MS is a chronic neurological disorder, this observational cohort study will span a~     30-year time frame.~   "
43753|NCT02994108|"~     Human Papillomavirus (HPV) is a common sexually transmitted infection that can cause cancer~     (anal, penile, oropharyngeal) and genital warts in men. Due to their sexual practices (e.g.,~     receptive anal intercourse), men who have sex with men (MSM) are at particularly high risk~     for HPV infection and are disproportionately affected by HPV-related cancers. A safe and~     effective vaccine is available to prevent HPV infection, yet HPV vaccination rates in the~     U.S. have been low, particularly among males. To remedy this gap, the goal of this study is~     to develop and pilot test a text messaging intervention to increase HPV vaccination in young~     MSM.~      The study has two specific aims:~        1. Develop, iteratively refine, and pre-test messages using a formative research procedure~          for designing targeted health interventions. The procedure consists of the following~          steps: 1) conduct online focus groups, an online survey, and in-depth interviews to~          inform message content, 2) draft initial messages based on focus group findings and~          pilot data, 3) refine message content and assess acceptability using content advisory~          teams, 4) conduct internal alpha testing to ensure software functionality, and 5) beta~          test the protocol.~        2. Test the feasibility, acceptability, and preliminary efficacy of the txt2protect (t2p)~          text messaging intervention in a pilot randomized controlled trial (RCT). To achieve~          this aim, 460 unvaccinated MSM (ages 18-25) who live in the Chicago metro area will be~          randomly assigned to the treatment (t2p) or control condition. The treatment condition~          will receive a culturally appropriate text messaging-based HPV vaccination intervention~          based on the Information, Motivation, and Behavioral Skills model, whereas the control~          condition will receive a text messaging-based sexual health intervention that includes~          basic facts about HPV vaccination readily accessible online.~      Primary outcome measures include intervention feasibility (e.g., retention in the trial),~     acceptability (satisfaction with the intervention), and preliminary efficacy as determined by~     initiation (receipt of the first dose) and completion of the 3-dose HPV vaccine series at the~     end of the 9-month trial.~      The study team hypothesizes that participants in the t2p condition (vs. control) will report~     greater acceptability of the intervention and will be significantly more likely to initiate~     and complete the 3-dose HPV vaccine series by the end of the trial.~   "
43754|NCT02994095|"~     This was a pilot study to assess the feasibility and acceptability of training Community~     Health Agents in Motivational Interviewing in real-life primary care centers.~   "
43755|NCT02994082|"~     This is a pilot study designed in an effort to develop and improve access to effective~     treatments for tobacco use in rural Veterans using a tailored intervention approach.~     Specifically, we will evaluate a combined behavioral and pharmacological smokeless tobacco~     cessation which concomitantly addresses comorbid issues commonly experienced by rural tobacco~     users including elevated depressive symptoms, risky alcohol use, and concerns about weight~     gain. The objectives are to:~        1. Evaluate the feasibility of an individually-tailored telephone intervention for rural~          smokeless tobacco users~        2. Examine the impact of the intervention on treatment utilization, patient satisfaction,~          and smokeless tobacco cessation.~   "
43756|NCT02994069|"~     Patients will receive standard of care radiation therapy to the primary tumor of the head and~     neck and involved nodal metastasis and draining nodal basin and either weekly cisplatin or~     every 3-week cisplatin in locally advanced SCCHN. The relationship between cisplatin toxicity~     and the level of reactive oxygen species generated by the drug in subjects with squamous cell~     carcinoma of the head and neck treated on this trial.~   "
43757|NCT02994056|"~     The primary objectives of this study are to evaluate the efficacy, safety, and tolerability~     of the treatment with sofosbuvir velpatasvir (SOF/VEL) fixed-dose combination (FDC) with~     ribavirin (RBV) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection~     and Child-Pugh-Turcotte (CPT) class C cirrhosis.~   "
43758|NCT02994043|"~     The goal of the AIM Study is to examine the effectiveness of Mindfulness Based Relapse~     Prevention (MBRP) versus Relapse Prevention (RP) for the treatment of Alcohol Use Disorders~     (AUD) by implementing an 8-week long intervention and examining neurobiological,~     immunological, and epigenetic characteristics of AUD.~   "
43759|NCT02994030|"~     Development of a new MS-based biomarker for the early and sensitive diagnosis of Duchenne~     disease from plasma~   "
43760|NCT02994017|"~     The objective of study is to prospectively determine if CPET with blood gas analysis should~     have a prognostic value in CF. The study plans to include 300 cystic fibrosis patients.~     Inclusion criteria will be: age >15 years, cystic fibrosis confirmed by chloride sweat test~     or genetic analysis, clinical and functional stability in the 2 month before CPET. Patients~     will perform a maximal exercise test on a cycloergometer during the inclusion visit, with~     pulmonary function testing and a six-minute walk test. The study will also include a visit~     every 6 months with: body mass index calculation, pulmonary function testing with DLCO~     (diffusing lung capacity for carbon monoxide), a six minute walk test, and~     antibacteriological study of sputum. The results of this study could help identify earlier~     the patients for referral to a lung transplantation centre, by using the usual criteria and~     the CPET abnormalities.~   "
43761|NCT02994004|"~     Hospital physicians are increasingly facing budgetary constraints that might have an impact~     on individual medical decisions (i.e. diagnostic or therapeutic decisions). This might~     translate into role conflict and ambiguity. We explore the medical decision-makingprocess of~     physicians usingfunctional MRI. Twenty hospital physicians will be asked to make simulated~     medical decisions during fMRI acquisitions, with and without explicit budgetary constraints.~     We will compare the fMRI data between the 2 modalities.~   "
43762|NCT02993991|"~     This is a Phase 1 Window of Opportunity study to evaluate the pharmacodynamic and immune~     effects of pre-operative therapy with Mocetinostat and Durvalumab on patients with squamous~     cell carcinoma of the oral cavity.~   "
43763|NCT02993978|"~     The purpose of the study is to evaluate the effect of changes in the care environment in~     pediatric radiotherapy. The definitions of the changes is a part of the study, and is~     constructed in collaboration with the institute of design at Umeå University. The~     implementation is however not part of the study, but done as part of Clinical routine.~      The study consist of two parts, where the first 1.5 years are a Control phase where the~     changes are designed and also function as a baseline period. The following 1.5 years are the~     case period where the Changes that are accepted for Clinical implementation are implemented.~      The impact of the changes are evaluated using surveys and interviews of both parents and~     children~   "
43764|NCT02993965|"~     The overarching goal of this study is to evaluate the effectiveness, cost-effectiveness and~     sustainability of utilizing statewide Immunization Information Systems (IIS) to conduct~     centralized reminder/recall (R/R) to improve Human Papiloma Virus (HPV) vaccination rates~     among adolescents ages 11-17 (with a more focused look at the new two dose series for 11-14~     year olds).~   "
43765|NCT02993952|"~     One of the major challenges faced by researchers working in the field of rehabilitation~     science is the ability to provide integrative approaches to the use of clinical practice. In~     this context it becomes increasingly necessary to construct investigative approaches, so that~     they can reach clinical practice in a shorter period of time,since the large volume of~     information produced globally does not impact in the short or medium term on new therapeutic~     recommendations. Among the various chronic painful entities, there is chikungunya fever as a~     highlight for having a rich clinical chronology in relation to pain. Its therapy is used done~     by drugs in almost all national and international consensuses, therefore therapy against pain~     in chikungunya fever is limited during the rehabilitation process. It is very important that~     the science of rehabilitation enhances methods of noninvasive brain modulation that enable,~     through the excitation or inhibition of specific cortical areas to produce pain inhibiting~     effects, providing a simple and low cost treatment to the clinical routine.Technological~     advances and non-invasive techniques to modulate brain function have been developed, for~     instance, Transcranial Direct Current Stimulation (tDCS).~      The objective of the present project is to present the tDCS as a new modality of physical~     rehabilitation for the patient with chronic pain resulting from chikungunya fever. The~     purpose of the study is to present physical, behavioral and social results of the application~     of tDCS in chikungunya fever, suggesting an improvement in the quality of life and functional~     status of the individual.~   "
43766|NCT02993939|"~     Despite their reliability and efficacy for shoulder surgery analgesia, above clavicle~     brachial plexus blocks are related with phrenic nerve palsy and diaphragm paralysis that may~     not be tolerated in patients with chronic pulmonary disease.~      This RCT will compare the classic Interscalene block with combined infraclavicular block plus~     suprascapular nerve block in patients going for arthroscopic shoulder surgery.~      Main outcome is static pain in the recovery room measured with NRS. Secondary outcomes are~     pain at 12 and 24 hrs and incidence of diaphragmatic paralysis.~   "
43767|NCT02993926|"~     The purpose of this study is to evaluate the long-term safety and efficacy of leuprorelin in~     the treatment of CPP (of at least 9 months of ENANTONE) in Chinese participants.~   "
43768|NCT02993913|"~     Phase I dose escalating trial. Primary objectives of this study are to assess the safety and~     tolerability of Simmiparib following single and multiple oral doses in patients with advanced~     solid malignancies, to determine the maximum tolerance dose (MTD) and dose limiting toxicity~     (DLT), and pharmacokinetic profile.~      The Secondary objective is to observe the preliminary antitumor effect of Simmiparib.~   "
43769|NCT02993900|"~     This research is being done to evaluate multimodality imaging, including magnetic resonance~     imaging-guided therapy (MRT), as a possible treatment for gynecologic cancers. The therapy~     takes place in the Department of Radiation Oncology at the Johns Hopkins SKCCC. The purpose~     of this study is to investigate the ability of MRI to successfully guide the placement of the~     brachytherapy applicator necessary to treat participants' gynecologic cancer. The~     Investigators want to see if the use of MRI will do a better job of assessing the tumor at~     the time of brachytherapy than the routinely used CT scan. The Investigators also want to~     determine if the use of MRI will enable doctors to reduce the radiation dose received by the~     body during the process of treating the tumor.~   "
43770|NCT02993887|"~     The investigators will conduct a randomized clinical trial pilot study to examine the~     effectiveness of a theoretically based intervention (called ReMind) encompassing two key~     components: (a) Resourcefulness Training for parent caregivers, and (b) daily mindfulness~     meditation delivered using a smart phone application (Stop, Breathe & Think™) with an~     intervention (Mind Only) that consists only of daily mindfulness meditation. Both components~     of the intervention have been tested separately (but not combined) and both interventions can~     be self-tailored, which meets the vital need for these caregivers to engage in~     self-management activities when it is convenient for them. The investigators will test the~     two arms of the intervention in 30 parents of technology-dependent children, 15 parents in~     each group. The investigators will collect mixed data at baseline, 3 months and 6 months~     after subject enrollment to describe changes in proximal and distal outcomes. The~     investigators aim to:~        1. Evaluate the intermediate (3 month) and long-term (6 month) effects of the ReMind and~          Mind Only interventions on study mediators (HPA Axis Function and stress, cognitive~          factors, resourcefulness) and determine if there are different effects between ReMind~          and Mind Only interventions.~        2. Evaluate the differences in distal psychological (Mental Health Related Quality of Life,~          Depressive Cognitions, Depressive Symptoms, Anxiety, Caregiver Burden), physical~          (Physical Health Related Quality of Life), and cost outcomes between subjects in the~          ReMind and Mind Only arms over time.~        3. Determine the moderating effects of parents' social support, demographics (age, gender,~          family income) and children's functional status on (a) proximal outcomes and the~          relationship between (a) the intervention arm and distal outcomes, and (b) HPA Axis~          Function, stress, cognitive factors and distal outcomes.~        4. Evaluate the impact of decentering on the association between the interventions and the~          proximal and distal outcomes.~        5. Explore differences in neurological processing (DMN and TPN) and decentering in proximal~          and distal outcomes associated with each intervention.~   "
43771|NCT02993874|"~     The aim of this study will be to verify the effect of creatine supplementation associated to~     clinical treatment of the functional capacity in patients with intermittent claudication.~   "
43791|NCT02993614|"~     CVD-REAL is a multinational, observational cohort study in patients with type 2 diabetes~     mellitus evaluating the comparative effectiveness of initiating treatment with a~     sodium-glucose co-transporter-2 (SGLT-2) inhibitor versus another glucose-lowering drug. This~     study will compare the risk of all-cause mortality and clinically relevant cardiovascular~     (CV) outcomes respectively in patients who are new users of SGLT-2 inhibitors with those who~     are new users of other glucose-lowering drugs. CVD-REAL is aiming to collect data from~     approximately 4 million patients overall, from twelve countries across three major world~     regions.~   "
45711|NCT02968537|"~     The study aims to investigate the effects of a short computerized training as a therapeutic~     add-on to standard therapy in patients with alcohol-use disorder.~   "
43772|NCT02993861|"~     The study is a prospective, multi-center, open-label clinical trial. Study's purpose is to~     characterize the pharmacokinetics and safety of four oral anti-epileptics drugs~     (levetiracetam, valproic acid [divalproex sodium ER or immediate release formulation if~     inadequate enrollment}, topiramate, and oxcarbazepine) in a non-randomized sample of obese~     children and adolescents. The study's duration will be up to eleven days (up to seven days of~     screening and four days of pharmacokinetic sampling). Eligible participants ages 2 to 18~     years will be identified through outpatient clinic schedules and inpatient admissions at each~     clinic site. Participants receiving at least one of the study drugs per local standard of~     care will have pharmacokinetic concentrations in plasma drawn according to the specific~     dosing schedule for each drug. Other study measures include demographics, BMI, waist/hip~     ratio, medical history, concomitant medication history, documentation of study drug oral~     intake, adverse effects, and physical examination. The sample size will include 24~     participants for each anti-epileptic drug (total 96).~   "
43773|NCT02993848|"~     The North American Scapula Consortium (NASCon) is a multi-center injury specific outcomes~     registry.~      There currently exists a paucity of outcomes data in the literature on this patient~     population. The NASCon registry will be a resource in which investigators can conduct~     adequately powered clinical outcomes research resulting in higher quality research with~     meaningful results, improved patient care, and evidence-based advancement for the treatment~     of scapula fractures. Registries can lead to significant discoveries in comparative~     effectiveness specifically in areas where randomized control studies are not possible.~     Collecting post-treatment (operative and non-operative) patient outcome data for similar~     injury patterns has been shown effective in uncovering optimal standards for treatment.~   "
43774|NCT02993835|"~     Determination of fractional iron absorption from bouillon fortified with 3 labeled iron~     compounds.~   "
43775|NCT02993822|"~     The purpose of this study is to determine the effectiveness of three doses of orvepitant,~     taken once a day, in the treatment of chronic refractory cough.~   "
43776|NCT02993809|"~     The intent of this clinical study is to evaluate the safety of the injection composed of~     autologous bone marrow derived endothelial cells (BM-ECs) and platelet-rich plasma extract~     (PRPE) for the treatment of critical limb ischemia.~   "
43777|NCT02993796|"~     The purpose of this study is to develop a clinical database of individuals diagnosed with~     Krabbe disease in order to determine which symptoms herald the onset of clinical disease in~     the various phenotypes of Krabbe disease; to determine whether level of GALC enzyme activity,~     or a specific genetic mutation predict the clinical course; and to determine which~     neurodiagnostic tests predict onset and/or severity of the disease.~   "
43778|NCT02993783|"~     The purpose of this study is to assess the initial activity, tolerability, safety and to~     identify a recommended dose and regimen of vedolizumab intravenous (IV) administered for~     treatment of steroid-refractory acute intestinal GvHD in participants who have undergone~     allo-HSCT.~   "
43779|NCT02993770|"~     All patients with epiphora or eye discharge that admitted to our ophthalmic plastic clinic in~     Farabi hospital will be systemically evaluated. Those with confirmed diagnosis of primary~     nasolacrimal duct obstruction (PANDO) that need DCR by one senior ophthalmic plastic~     consultant, will be randomly assigned to one of the 2 treatment groups: Group 1 External DCR~     and group 2 En-DCR. Diagnosis of PANDO will be based on the presence of positive~     regurgitation test or irrigation test or dacryocystography (DCG) . All patients will undergo~     comprehensive ophthalmology examinations including best corrected visual acuity (BCVA),~     relative afferent pupillary defect (RAPD), slit lamp anterior segment evaluation, dilated~     fundoscopy with 78 D lens. Past history and review os systems will be elicited for~     medications, past or intercurrent dacryocystitis,trauma,past ocular and sinus surgeries,~     epiphora, discharge, ocular diseases, sinus/nasal diseases, diabetes mellitus, organ~     transplant, immunosuppressive drugs and immunodeficiency disorders.~      All operations will be performed under general or local anesthesia, based on patient and~     surgeon preferences.~      Surgical Technique:~      All En-DCR surgeries will be performed by a single ophthalmic plastic surgeon expert in~     endoscopic surgery (F.P.) with a modified powered endonasal endoscopic technique described by~     Wormold.~      Using a 0 degree 4-mm endonasal endoscope nasal mucoperiosteum in the area of the lacrimal~     sac will be incised and elevated. Then rhinostomy will be made using forceps, exposing~     lacrimal sac. Lacrimal sac will be opened and a Crawford silicone tube will be passed through~     puncta into nasal cavity and stabilized and will be kept for 2 months. After operation~     patients will receive nasal beclomethasone twice daily for 2 weeks, nasal drop phenylephrine~     0.25% four times daily and ophthalmic drop fluorometholone and Levofloxacin four times daily~     for one week.~      External DCR will be performed in a conventional manner [2]via a nasal side straight skin~     incision 1 cm medial to medial canthal area, 1 cm long, then orbicularis oculi muscle will be~     separated using blunt dissection to expose the periosteum overlying and medial to the~     anterior lacrimal crest. After incision of the periosteum, an osteotomy approximately 10 mm~     in diameter will be prepared. The lacrimal sac and then nasal mucosa will be opened by an H~     incision to form maximal anterior flaps. A Bodkin tube will be passed through puncta into~     nasal cavity of stabilized by multiple square knots at the end. The small posterior flaps~     will be cut and excised and anterior flaps will be sutured together with 2 or 3 6-0 vicryl~     sutures. The periosteum, orbicularis oculi muscle, will be sutured by 6-0 vicryl sutures.~     Skin will be sutured by Nylon 6-0 by interrupted style in the standard manner. Nasal packing~     will not be placed. All Ext-DCR operations will be performed by one of the two expert~     ophthalmic plastic surgeons (F.P and A.K.).~      The amount of bleeding will be estimated and recorded by the subtracting the total suction~     reservoir from the amount of irrigated fluid through syringe during operation. Time of~     operation will be estimated and recorded from the time of anesthetics injection to removing~     the drape.~      One week after operation patients will be asked to report post-operative pain and discomfort~     by visual analogue score scale (0-10).~      27 Seven days after operation skin sutures of patients in group 2 will be removed if skin is~     healed, and complications, if any, will be detected and recorded in the special data sheets.~     Nasal bleeding, medial canthal swelling and erythema, ocular surface fluorescein staining and~     any complications will be detected and recorded. Dye disappearance test (DDT) will be checked~     and recorded. Epiphora will be recorded according to modified Munk epiphora staging scale.~      Two months after operation, ocular surface will be checked by fluorescein for staining of~     cornea and conjunctiva. Then silicone tube will be removed. epiphora will be recorded~     according to our staging system. Dye disappearance test (DDT) and Fluorescein Dynamic Dye~     test (FDDT) and irrigation test, epiphora and skin scar by visual analogue scale (VAS) visual~     analogue scale will be checked in months 2, 6, 12, 18 and after operation. Satisfaction will~     be checked 2 mo and 18 mo after operation by VAS. Any grade of daily epiphora or return of~     fluid>20% through opposite punctum in irrigation test or negative FDDT (absence of fluid~     passage) will be regarded as functional or anatomic failure, respectively. Any complication~     will be recorded in the specific forms.~      All pre-operative and post-op examinations will be performed by a masked senior ophthalmology~     resident subjective data will be checked and recorded by a trained nurse~   "
43780|NCT02993757|"~     The aim of the study is to assess the safety and immunogenicity of the CYD dengue vaccine~     when administered concomitantly or sequentially with Gardasil® (Human Papillomavirus~     Quadrivalent [Types 6, 11, 16, and 18] Vaccine, Recombinant).~      Primary objectives:~        -  To demonstrate that the humoral immune response (in terms of geometric mean~          titers[GMTs]) to Gardasil after concomitant administration is non-inferior to sequential~          administration with the CYD dengue vaccine measured 28 days after the last dose of~          Gardasil.~        -  To demonstrate that the humoral immune response to the CYD dengue vaccine after~          concomitant administration is non-inferior to sequential administration with Gardasil~          measured 28 days after the last dose of the CYD dengue vaccine.~      Secondary Objectives:~        -  To demonstrate that the humoral immune response (in terms of seroconversion) to Gardasil~          after concomitant administration is non-inferior to sequential administration with the~          CYD dengue vaccine measured 28 days after the last dose of Gardasil~        -  To describe the humoral immune response to Gardasil at baseline and after each dose of~          Gardasil in each and any group~        -  To describe the humoral immune response to the CYD dengue vaccine at baseline and after~          each dose of the CYD dengue vaccine in each and any group~        -  To describe the safety of Gardasil and the CYD dengue vaccine after each and any dose in~          each group.~   "
43781|NCT02993744|"~     It is the aim of this study to detect the effect of Betamethasone on the maternal~     inflammatory parameters C-reactive protein (CRP) and leukocytes of a pregnant woman under~     threat of preterm delivery, for example because of a cervical infection.~   "
43782|NCT02993731|"~     This is a randomized, open-label, multi-center, phase 3 study of napabucasin plus weekly~     nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine for adult~     patients with Metastatic Pancreatic Ductal Adenocarcinoma.~   "
43783|NCT02993718|"~     Under the hypothesis that dexmedetomidine sedation would result in less upper airway~     obstruction, we evaluated the occurrence of upper airway collapse or the requirement of~     airway intervention in patients with obstructive sleep apnea during dexmedetomidine or~     propofol sedation.~   "
43784|NCT02993705|"~     Multicenter phase II study on trabectedin in patients advanced uterine and ovarian~     carcinosarcoma. Patients will receive trabectedin until disease progression or unacceptable~     toxicity. Disease response evaluation will be assessed every 9 weeks.~   "
43785|NCT02993692|"~     The aim of study was to compare the hemodynamic responses and adverse events associated with~     nasotracheal intubation (NTI) using a fiberoptic bronchoscope (FOB) and a direct laryngoscope~     (DLS) in children undergoing general anesthesia for outpatient dental surgery. Eighty~     children (aged 5-15 years) were scheduled to undergo outpatient dental surgery under general~     anesthesia and who required nasotracheal intubation were included.~   "
43786|NCT02993679|"~     The objective of this randomised cohort study was to evaluate the knee rotational stability~     after the single-bundle ACL reconstruction (SB) with addition of the ALL reconstruction and~     to compare it with the double-bundle ACL reconstruction technique (DB) and to analyse when~     the ALL is necessary to reconstruct.~   "
43787|NCT02993666|"~     This study is conducted to evaluate the effectiveness of forced air warming using upper and~     lower body blankets by measuring core body temperature in patients undergoing video-assisted~     thoracic surgery in the lateral decubitus position over 2 hours of general anesthesia.~   "
43794|NCT02993575|"~     The pharmacokinetics of flucloxacillin are expected to be different in ICU patients compared~     to non-ICU patients. The investigators will determine total and free flucloxacillin~     concentrations in 30 ICU patients, who will get continuous (n=10) or intermittent infusion~     (n=20) of flucloxacillin as standard care.~      Full pharmacokinetic curves will be taken for individual patients on the intermittent dosing~     regimen and limited sampling will be taken for individual patients on the continuous dosing~     regimen on day 2 and 4.~   "
43795|NCT02993562|"~     This project has the following primary aims:~      To measure changes in appetite and food intake in newly diagnosed hypothyroid patients during~     the first six months after starting levothyroxine (L-T4) substitution therapy~      Secondary aims are:~      To delineate the effect of L-T4 substitution therapy on thyroid status, body weight, body~     mass index (BMI), body composition, physical activity, glycaemic control, postprandial gut~     and pancreatic hormone responses, gastric and gall bladder emptying, resting energy~     expenditure (REE), quality of life (QOL) and cognitive function~   "
43796|NCT02993549|"~     Head injury is a common and devastating condition that can affect people at any stage of~     their lives. The treatment of severe head injury takes place in intensive care where~     interventions are designed to protect the brain from further injury and provide the best~     environment for recovery. A number of different monitors are used after head injury,~     including a monitor called microdialysis, to measure how the brain is generating energy.~     Abnormalities in these monitors guide doctors to the right treatments when the brain is at~     risk of further injury. There are lots of ways that the brain can be injured further after~     head injury such as raised pressure in the skull from brain swelling, low oxygen levels and~     low glucose levels. In this study we aim to combine information from all of these monitors to~     figure out what the underlying problem is and choose the right intervention to treat the~     problem that is affecting the patient at the time and compare this with previous treatment~     protocols to see if it improved outcome.~      Aim:~      To establish and validate a protocol to treat abnormalities in a microdialysis measure called~     lactate/pyruvate ratio (LPR) that reflects how cells are generating energy, and compare it~     with patient cohorts not being monitored using the current protocol.~   "
43797|NCT02993536|"~     The purpose of the study is to assess the evolution of B cells at a genetic and~     surface-marker level in high-risk CLL after idelalisib-rituximab treatment. The targeted~     population includes 20 subjects ages 18 or older diagnosed with high-risk CLL. This will~     include patients with relapsed or refractory disease who require therapy with idelalisib and~     rituximab as per FDA label. This is an observational study for peripheral blood samples of~     these patients collected at pre-determined time points.~   "
43798|NCT02993523|"~     Acute Myeloid Leukaemia (AML) is an aggressive and rare cancer of myeloid cells (a white~     blood cell responsible for fighting infections). Successful treatment of AML is dependent on~     what subtype of AML the patient has, and the age of the patient when diagnosed.~      Venetoclax is an experimental drug that kills cancer cells by blocking a protein (part of a~     cell) that allows cancer cells to stay alive. This study is designed to see if adding~     venetoclax to azacitidine works better than azacitidine on its own.~      This is a Phase 3, randomized, double-blind (treatment is unknown to patients and doctors),~     placebo controlled study in patients with AML who are >= 18 or more years old and have not~     been treated before. Patients who take part in this study should not be suitable for standard~     induction therapy (usual starting treatment). AbbVie is funding this study which will take~     place at approximately 180 hospitals globally and enroll approximately 400 patients.~      In this study, 2/3 of patients will receive venetoclax every day with azacitidine and the~     remaining 1/3 will receive placebo (dummy) tablets with azacitidine.~      Patients will continue to have study visits and receive treatment for as long as they are~     having a clinical benefit. The effect of the treatment on AML will be checked by taking~     blood, bone marrow, scans, measuring side effects and by completing health questionnaires.~     Blood and bone marrow tests will be completed to see why some people respond better than~     others. Additional blood tests will be completed for genetic factors and to see how long the~     drug remains in the body.~   "
43799|NCT02993510|"~     The purpose of this study is to evaluate the safety and effectiveness of using Chondro-Gide®~     collagen membrane either sutured or glued compared to microfracture alone in the treatment of~     symptomatic cartilage defects of the knee.~   "
43800|NCT02993497|"~     In patients undergoing spinal anesthesia, the investigators used an Infra-red camera and a~     respiratory volume monitor to determine the accuracy of the ventilation rate of the infra red~     camera by measuring the respiratory rate, ventilation volume, and ventilation volume with~     respiratory volume monitor.~   "
43801|NCT02993484|"~     The overall aim of this study is to examine the role of mitochondrial respiration in human~     diabetic tissue before and after ischemia. Furthermore we will examine the ability of~     ischemic preconditioning (IPC) to preserve the mitochondrial function and hemodynamic~     performance of both non-diabetic and diabetic fibers after ischemia. To increase our~     understanding on the metabolic changes during ischemia in both non-diabetic and diabetic~     tissue we will use Dimethyl Malonate and examine the impact of this blockade on post-ischemic~     mitochondrial respiration.~   "
43802|NCT02993471|"~     This study is known as a drug interaction study. The purpose is to learn about how~     ixekizumab may affect the blood levels of a mixture of commonly used drugs (caffeine,~     omeprazole, warfarin, dextromethorphan, and midazolam) that are metabolized by cytochrome~     P450. Each participant will complete two study periods. Participants will take the mixture of~     commonly used drugs (plus vitamin K) by mouth on 3 occasions (prior to treatment with~     ixekizumab and after 1 and 12 weeks of treatment with ixekizumab). The study will last about~     17 weeks, including follow-up. Screening must be completed prior to study start.~   "
43803|NCT02993458|"~     The Camp DASH study trial will compare the effect of two dietary patterns and two levels of~     sodium intake on blood pressure and blood lipids in adolescents in the upper third of~     distribution for blood pressure. The two dietary patterns are based on the Dietary Approaches~     to Stop Hypertension (DASH) trial in adults.~   "
43804|NCT02993445|"~     The purpose of this study is to evaluate the effect of complementary and alternative~     therapies, specifically alternate nostril breathing and foot reflexology, on intraocular~     pressure in patients with ocular hypertension.~   "
43805|NCT02993432|"~     It is currently unknown if there is a way to decrease the risk of cesarean delivery when~     undergoing cervical ripening and induction of labour. Some research suggests a Foley catheter~     placed through the cervix and filled to 80cc may decrease this risk. We wish to run a large~     scale trial to see if Foleys filled to 80cc decrease the risk of Cesarean section compared to~     the commonly used medication for cervical ripening, prostaglandins. Before we can undertake a~     large trial, we need to do a pilot to see if women will agree to participate in this type of~     study. As well, a pilot will help with trouble shooting prior to a large trail, to improve~     the chances of successfully answering this clinically important question.~   "
43806|NCT02993419|"~     This prospective, multicenter, randomized, double-blind, placebo-controlled clinical study,~     into the group of children in the hospital that use clinical antibiotics from one month to~     three years old，by observing the given antibiotics at the same time with the whole bowel raw~     or placebo, prevent the happening of the antibiotic associated diarrhea, evaluate the whole~     bowel prevention clinical efficacy and safety of AAD.~   "
43807|NCT02993406|"~     The purpose of this study is to determine if treatment with bempedoic acid (ETC-1002) versus~     placebo decreases the risk of cardiovascular events in patients who are statin intolerant.~   "
43808|NCT02993393|"~     Abstract Background and Goal of study Teaching and learning in airway management are~     essential in anesthetic field. Though simulation-based and problem-based learning are~     sophisticated learning tool, neither of them manifests the superior benefit. We would like to~     compare the teachers' and students' attitudes on these two learning methods.~      Material and Methods After IRB approval No. 369/2558(EC3). A prospective,~     questionnaires-based study was performed amongst volunteered, consent-signed, 10~     anesthesiologists and 40 nurse anesthetist students. After stratified randomization, ten~     students simultaneously attended either SBL or PBL course one at a time. Six weeks later, a~     crossover technique was applied for both groups. At the end of project, teachers and students~     had to response to Likert's scale questionnaires.~      The teachers' questionnaire based on table of specification of the learning contents,~     consisted of 4 parts: airway evaluation, patient preparation, strategic planning and follow~     up care. The students' questionnaire comprised 3 parts: learning content, process and~     evaluation.~      The validation of the questionnaire was determined by three board-certified~     anesthesiologists. The index of item objective congruence was 0.80 and 0.82 with Cronbach's~     Alpha of 0.97 and 0.92 respectively.~   "
43809|NCT02993380|"~     Patients with chronic kidney disease (CKD) have higher mortality rate than general~     population. Especially, the most common cause of mortality was known as cardiovascular~     disease that account for almost 50 percent in patients with dialysis. Mediterranean diet was~     reported for lowering risk of coronary artery disease in general population. Mediterranean~     diet is not acceptable in CKD patients because of restriction of potassium, phosphorus, and~     protein.~      Relatively proper food among Mediterranean diet for hemodialysis patients is olive oil. Many~     researchers usually preferred olive oil as control group for evaluating effect of omega-3~     fatty acid. However, previous studies reported that control groups using olive oil of 3g in a~     day have shown increased components of omega-3 fatty acid such as eicosapentaenoic acid (EPA)~     or docosahexaenoic acid (DHA). Therefore, cardioprotective effect of olive oil may be~     associated with increasing of omega-3 fatty acid levels.~   "
43810|NCT02993367|"~     Vascular cognitive impairment no dementia (VCIND) is very common among the aged and tends to~     progress to dementia, but there have been no proper large-scale intervention trials dedicated~     to it. VCIND caused by subcortical ischemic small vessel disease (hereinafter, subcortical~     VCIND) represents a relatively homogeneous disease process and is a suitable target for~     therapeutic trials investigating VCIND. Preclinical trials showed that Butylphthalide Soft~     Capsules is effective for cognitive impairment of vascular origin. In this randomized,~     double-blind, placebo-controlled trial, the investigators apply fMRI study the effects of~     Butylphthalide Soft Capsules in patients with VCIND.~   "
43811|NCT02993354|"~     The EUM (electrical uterine myography) (OB Tools, Israel) was tested and found to be reliable~     as a non-invasive method for evaluating uterine contractions and the fetal heart rate. It is~     safe and effective in monitoring uterine contractions. The investigators propose to perform a~     series of studies to validate the accuracy and clinical usefulness of the EUM device by~     simultaneously monitoring patients with current methods (with either external or internal~     devices) as clinically indicated and with the EUM device. Providers will be blinded to the~     results of the EUM device. The investigators will continue care as per current guidelines~     using the information obtained from the current monitoring methods. Information obtained from~     the EUM devices will not be used to determine the clinical course of action.~   "
43812|NCT02993341|"~     Mechanisms by which to reduce exposure to allogeneic blood are of financial and clinical~     benefit in the hip fracture population. Tranexamic acid (TXA) is an inexpensive medication~     with low complication risk. Its use in the hip fracture population is unproven. The purpose~     of this study is to evaluate the efficacy and safety of topical tranexamic acid in reduction~     of peri-operative blood loss in hip fracture surgery.~   "
43813|NCT02993328|"~     This trial will be a double-blind, single-center, randomized, placebo controlled study to~     evaluate the safety, tolerability, and efficacy of SAN021 study drug when administered for up~     to 42 days to adults between the ages of 18 to 65 years who have a clinical diagnosis of~     mild-to-moderate plaque psoriasis.~   "
43814|NCT02993315|"~     The aim of this study is to determine whether adjuvant treatment with nDC vaccination, after~     complete radical lymph node dissection or sentinel node procedure in stage IIIB and IIIC~     melanoma patients, improves recurrence-free survival (RFS) as compared to treatment with~     matching placebo.~   "
43815|NCT02993302|"~     Maturity level of dendritic cells (DC) plays a pivotal role in initiating and regulating~     autoimmunity. In Graves' disease (GD), DCs have more active immune responses than those in~     healthy subjects. Our previous study demonstrated immunoregulatory effects of in vitro~     1,25-D3 on maturation of DC in GD patients. This study aims to evaluate the effect of oral~     1α-D3 on DC maturation in GD patients.~   "
43865|NCT02992652|"~     -  The investigators evaluated the role of allopurinol in prevention of post-ERCP~          pancreatitis.~        -  100 Egyptian patients who were candidates for ERCP were included and divided into two~          groups. Group 1 (study group) included 50 patients who received two doses of allopurinol~          300 mg each, 15 hours and 3 hours before ERCP and Group 2 (control group) included 50~          patients who did not receive allopurinol prophylaxis.~   "
43816|NCT02993289|"~     Medication-overuse headache (MOH) is a disabling condition, yet treatable. According to~     European guidelines and based on evidence, multidisciplinary detoxification is the first~     choice of treatment for MOH. However, consensus about the details in such detoxification~     programs is lacking. Contrary, other headache specialists believe more in treating chronic~     headache with medication overuse with single-therapy of prophylaxis and no withdrawal of~     acute medication, based on randomized controlled double-blinded placebo trial with~     prophylaxes. Only a single RCT has compared single-therapy with prophylaxis to~     detoxification. However there was no significant difference.~      AIM:~        1. To compare three different treatment protocols in order to improve the therapy of MOH.~        2. To test several baseline variables for being potential predictors for good treatment~          outcome.~        3. To examine the role of epigenetics in MOH.~   "
43817|NCT02993276|"~     PROSPECTIVE COHORT EVALUATION OF NEUROCAP® In the Treatment of symptomatic Neuroma (PROTECT~     Neuro)~      This post-market surveillance study is conducted to provide post market surveillance~     information regarding long-term performance and ease of use of the Polyganics nerve capping~     device (NEUROCAP®) for reduction of the development of peripheral symptomatic end-neuroma.~   "
43818|NCT02993263|"~     The investigators propose to estimate the sensitivity and specificity of the VectraplexECG~     System for detecting acute myocardial ischemic injury, including acute myocardial infarctions~     after major non-cardiac surgery.~      A 10 second CEB dynamic sequence recording will be obtained immediately after surgery in the~     post-anesthesia care unit.~      On the first, second and third post operative morning a 10 second CEB dynamic sequence will~     be recorded. Blood will be sampled for troponin as well.~      On the first, second and third post operative afternoons a 10 second CEB dynamic sequence~     will be recorded.~      The morning 10 second CEB dynamic sequence and blood draw for troponin will continue as long~     as the patient remains hospitalized. The afternoon 10 second CEB dynamic sequence will~     continue as long as the patient remains hospitalized.~   "
43819|NCT02993250|"~     The main purpose of this study is to evaluate the safety and tolerability of a combination~     treatment of AL-335, odalasvir (ODV), and simeprevir (SMV) for 8 weeks in Japanese~     participants with genotype 1 or 2 chronic hepatitis C virus (HCV) infection without cirrhosis~     and for 12 weeks in direct-acting antiviral (DAA)‑naive Japanese participants with genotype 1~     or 2 chronic HCV infection with compensated cirrhosis.~   "
43820|NCT02993237|"~     The primary purpose of this study is to assess the acceptability of swallowing the~     darunavir/cobicistat (DRV/COBI) and darunavir/cobicistat/emtricitabine/tenofovir alafenamide~     (D/C/F/TAF) fixed-dose combination (FDC) tablets, using matching placebo tablets, in human~     immunodeficiency virus (HIV) -1 infected adolescent patients.~   "
43821|NCT02993224|"~     Study to evaluate patient preference of deferasirox FCT or deferasirox DT in patient with~     transfusion - dependent thalassemia or non-transfusion -dependent thalassemia as measured by~     preference questionnaire at Week 48~   "
43822|NCT02993211|"~     Conventionally, transurethral standard resection (SR) of bladder tumour is performed in a~     piecemeal manner. Transurethral en bloc resection (EBR) has been described as an alternate~     surgical technique in bladder tumour resection. By preventing tumour fragmentation and~     ascertaining complete tumour resection by histological assessment of the EBR specimen, we~     hypothesized that EBR could reduce disease recurrence as compared to SR.~   "
43823|NCT02993198|"~     The Cardio-Oncology program at Northwestern offers care to cancer patients who develop~     cardiac toxicities from chemotherapy. Breast cancer patients with the tumor marker for HER2~     necessitate treatment with anthracycline and/or trastuzumab and pertuzumab-based~     chemotherapies, which are known to cause cardiac toxicities. Breast cancer patients will~     undergo a cardio-oncology echocardiogram which incorporates advanced left ventricular~     assessment by utilizing deformation or strain imaging during chemotherapy treatment for~     surveillance of cardiac toxicities. The aims of this project are:~        1. To create a registry of both clinical, and echocardiographic variables, biomarkers, and~          genetic analysis that will be used to develop a risk model to predict LV dysfunction in~          early stage breast cancer patients undergoing chemotherapy with anthracycline and/or~          trastuzumab and pertuzumab-based chemotherapy regimens.~        2. To propose a new management algorithm for initiation of prophylactic beta-blocker~          therapy for early stage breast cancer patients with preclinical cardiac toxicities~          demonstrated by strain parameters.~        3. To determine if initiation of prophylactic beta-blocker therapy in patients with early~          cardiac toxicity can delay or prevent a drop in LV EF and the development of clinical~          heart failure.~        4. To explore serial measurements of a suite of novel biomarkers during ongoing anticancer~          treatment that are presumed but not yet proven to be predictive of cardiac dysfunction~          in women with breast cancer.~        5. To identify DNA biomarkers of predilection to cardiotoxicity.~        6. To generate hiPSC to validate markers predictive of cardiotoxicity.~   "
43824|NCT02993185|"~     The purpose of Making Healthy Decisions is to design and rigorously evaluate a new sexual~     health education program, Your Move (YM) against a nutrition control program, Eat Smart~     (ES). YM is intended to improve teen females' (ages 14-19) ability to make healthy sexual~     decisions with the ultimate goal of reducing unplanned pregnancies and STIs.~   "
43825|NCT02993172|"~     The Copenhagen City Heart Study is an ongoing cardiovascular population study initiated in~     1976 which has examined approximately 25,000 individuals from the general population. The~     initial sample has been re-invited up to four times and supplemented by younger individuals.~     The study includes questionnaires, clinical assessment and biomarkers. The population have~     been followed in a number of outcome registries and more than 900 scientific papers have been~     published.~   "
43826|NCT02993159|"~     This randomized phase IIB trial studies how well tamoxifen or afimoxifene works in treating~     patients with estrogen receptor positive breast cancer. Estrogen can cause the growth of~     breast cancer cells. Hormone therapy using tamoxifen citrate or afimoxifene may fight breast~     cancer by blocking the use of estrogen by the tumor cells.~   "
43827|NCT02993146|"~     This phase I trial studies the side effects and best dose of ropidoxuridine when given~     together with whole brain radiation therapy in treating patients with cancer that has spread~     to the brain. Ropidoxuridine may help whole brain radiation therapy work better by making~     cancer cells more sensitive to the radiation therapy.~   "
43828|NCT02993133|"~     The main autoimmune bullous dermatoses are pemphigus and cicatricial pemphigoid. Pemphigus is~     an autoimmune dermatological disease characterized by the production of anti-desmoclesin~     antibodies 1 and 3, affecting the skin and mucous membranes.The cicatricial pemphigoid is an~     autoimmune dermatological disease, characterized by the production of anti-zone antibodies of~     the basal membrane and characterized by a predominant mucosal involvement. Mycophenolic acid~     (MPA) is an increasingly used form of corticosteroid. Despite its increasing use,~     pharmacokinetics in autoimmune bullous dermatosis remain little studied.~   "
43829|NCT02993120|"~     This is a multicenter observational cohort study with both retrospective and prospective data~     collection components in subjects with ASCVD.~      The purpose of this study is to better understand cholesterol treatment patterns in the~     context of a changing landscape in subjects with ASCVD.~   "
43830|NCT02993107|"~     The purpose of this study is to demonstrate the safety, tolerability, and efficacy of AR101~     through characterized oral desensitization immunotherapy (CODIT) in peanut-allergic children~     and adults who have completed the ARC003 study.~   "
43831|NCT02993094|"~     This is an open-label phase I/II study for patients with advanced (locally advanced~     inoperable or metastatic) triple-negative breast cancer progressing after first-line therapy~     receiving ixazomib on days 1, 8, and 15 in combination with carboplatin on days 1, 8, and 15.~     Cycles will be repeated every four weeks.~   "
43832|NCT02993081|"~     Study of refractive changes after capsulotomy with YAG laser in facectomized patients.~   "
43833|NCT02993068|"~     The goal of this research study is to test the effects of online genetic education alone or~     in combination with telephone genetic counseling in order to compare the two methods and the~     stress a person feels about their risk of cancer.~      Researchers also want to learn how these strategies may improve your understanding of~     genetics, your ability to complete a quiz about genetics, and your quality of life.~      This is an investigational study. The saliva-testing kit and genetic testing done in this~     study is FDA approved and will be processed in a Clinical Laboratory Improvement Amendments~     (CLIA) certified laboratory.~      Up to 3000 participants will be enrolled in this study.~      URL: https://magenta.mdanderson.org~   "
43834|NCT02993055|"~     A Phase I dose escalation study involving healthy subjects.~   "
43835|NCT02993042|"~     Robot-assisted gait training can improve gait ability of patients with Parkinson's disease by~     repeating a normal gait pattern with high intensity. This study is a feasibility study to~     investigate whether robot-assisted gait training can be applied to improve walking autonomy~     in patients with Parkinson 's disease.~   "
43836|NCT02993029|"~     Osteoarthritis (OA) of knee is the most common form of arthritis in the world1e, and it has~     received growing attention in the society because of the increase of old age population,~     disabled people, and medical expenses from this disease. 99Tc-MDP is effective for rheumatoid~     arthritis. Therefore, the investigators try to investigate the effects of 99Tc-MDP treatment~     in patients with osteoarthritis of knee as compared with celecoxib.~   "
43837|NCT02993016|"~     Total knee arthroplasty (TKA) has a high success rate for addressing pain and improving~     function. However, in instances where incorrect positioning and malignment of the TKA~     components are observed, patients can experience a range of negative postoperative outcomes~     such as loss of thickness of polyethylene tibial bearings, eccentric loading, implant~     loosening, and eventual early revision. To avoid these complications, achieving a~     postoperative alignment within the range of 0°±3° of the mechanical axis is recommended.~     Manual intramedullary/extramedullary guides are not thought to be capable of consistently~     achieving axes in this range, and though computer-assisted navigation has shown superior~     results in comparison with conventional instrumentation, it is also limited by increased~     surgical times and no clear superiority in improving short-term clinical outcomes. Thus,~     there has been in a push in the orthopaedic community to create more precise technologies to~     aid in the reconstruction of the knee's mechanical axis. Patient-specific instrumentation~     (PSI), which uses anatomical data obtained primarily from pre-operative axial computed~     tomography (CT) or magnetic resonance imaging (MRI) to create disposable cutting jigs~     individualized to the patient's unique anatomy, was created with this goal.~      This study aims to compare the clinical results of conventional and patient-specific~     instruments in total knee arthroplasty.~   "
43838|NCT02993003|"~     Core temperature is of greatest interest in terms of temperature monitoring as it is thought~     to represent the temperature of the vessel-rich groups that are instrumental in~     thermoregulatory control. The nasopharynx is among the recommended temperature monitoring~     sites for core body temperature. It is the part of the pharynx that lies above the soft~     palate. Anteriorly it opens to the nasal cavities through the choanae; inferiorly it~     communicates with the oropharynx through the pharyngeal isthmus. Nasopharyngeal temperatures~     are accurate in adults when probes are inserted between 10 and 20 cm.~      The optimal depth for insertion of nasopharyngeal probes remains poorly defined in infants~     and children. While some data suggest that anthropometric measurements are well correlated~     with endoscopic measurements in infants based on weight, the accuracy of temperature~     measurements at these and other distances has yet to be quantified. The investigators thus~     propose to determine the insertion depth (or range of depths) for nasopharyngeal temperature~     proves that best approximate core temperature as measured in the distal esophagus in infants~     and children of various sizes. The comparison site will be the distal esophagus since there~     is broad consensus that the distal third of the esophagus it at core-body temperature.~      For the two groups of infants aged up to twelve months, the nasopharyngeal probe will be~     marked with indelible ink from 2-10 cm in 1-cm increments and inserted 10 cm. For the two~     groups of children between 1 and 5 years, the nasopharyngeal probe will be marked with~     indelible ink from 2-15 cm in 1.5-cm increments and inserted 10 cm. For older children, a~     nasopharyngeal probe will be marked with indelible ink from 2 to 20 cm at 2 cm increments~     from its tip, and inserted 20 cm.~      Both nasopharyngeal and esophageal temperatures will initially be recorded 30 minutes after~     induction of anesthesia. Nasopharyngeal probes will then be withdrawn at the designated~     increment for each age group and will be equilibrated for 5 minutes before the temperature is~     recorded. Thereafter, the nasopharyngeal withdrawal sequence will be repeated. The number of~     measurement will depend on the initial depth of insertion, with measurements continuing until~     only 2 centimeters remain in the nostril.~   "
43839|NCT02992990|"~     To assess whether the addition of a bladder tumor biopsy improves the level of agreement~     between the pretreatment endoscopic impression and the final postoperative pathology~     determination of stage and grade in non-muscle-invasive urothelial carcinoma of the bladder.~   "
43840|NCT02992977|"~     This is an open-label Phase 1 study to determine the safety and tolerability of single-agent~     treatment with AutoSynVax™ vaccine with QS-21 Stimulon® adjuvant in subjects with advanced~     cancer that is refractory to standard therapies and a life expectancy of ≥6 months from the~     time tissue is obtained. A minimum of 6 (≤20) subjects will be enrolled to receive every~     other week subcutaneous injection of 240 μg AutoSynVax™ vaccine + 50 μg QS-21 Stimulon®~     adjuvant for up to 1 year.~   "
43866|NCT02992639|"~     To investigate weight loss effect with mild calorie restriction on circulating levels of~     liver enzymes in nondiabetic and overweight subjects with high visceral fat area [visceral~     fat area (VFA) at L4 ≥ 100 cm²].~   "
43842|NCT02992951|"~     Surgical site infection is an infection at a place in the body where surgery has taken place,~     and has been reported in around 5% of people undergoing an operation. In vascular surgery,~     infection rates are as high as 30%. Methods to reduce this rate of infection should be~     investigated thoroughly for their effectiveness and cost-effectiveness.~      The investigators aim to conduct a research trial examining one such method. Leukomed Sorbact~     is a wound dressing coated with a chemical (DACC) derived from spider-silk that interacts~     with, and binds bacteria, causing them to be mechanically removed from a wound when the~     dressing is changed.The trial aims to compare the effectiveness of this dressing to a~     standard, non-coated dressing, in the reduction of surgical site infection.~      712 patients from a number of centres across the UK will be recruited to this study. Adult~     patients who are having a vascular surgery operation will be approached for entry into the~     trial. The trial will be explained to them, as well as an explanation that participation is~     voluntary and their operation or other aspects of their care will not be impacted in any way~     should participants not wish to participate.~      Participants will be randomised by computer into one of two groups - one group whose wounds~     are dressed with Leukomed Sorbact, and the other whose wounds are dressed with a standard~     dressing. Patients will be followed up at 5-7 days and 30 days, and at 1 year. At the follow~     up, their wounds will be inspected for infection, and participants will be asked to complete~     short questionnaires measuring quality of life.~      The trial will aim to answer a number of questions, with the primary question being does a~     DACC coated dressing applied after an operation reduce the risk of an infection at the~     surgery site? It will also ask whether this treatment is cost-effective and whether it~     promotes satisfactory healing.~   "
43843|NCT02992938|"~     Remifentanil is a potent opioid widely used during the administration of general anesthesia.~     There is a lot of evidence that suggest that the used of remifentanil is associated with the~     development of hyperalgesia (a reduction of nociceptive thresholds). However, the mechanism~     of this hyperalgesia is not fully understood.~      Recently, it was demonstrated that the disruption of the Cl- homeostasis could be involved.~     Interestingly, this was prevented in a murine model with the administration of Acetazolamide,~     a carbonic anhydrase inhibitor. In our clinical trial we will try to determine if the~     preoperative administration of acetazolamide could prevent the hyperalgesia induced by~     remifentanil in patients scheduled for thyroidectomy with general anesthesia.~   "
43844|NCT02992925|"~     The purpose of this study is to:~        -  (cohort 1) evaluate safety and immunogenicity (Haemophilus influenzae type b, Hib) of~          BK1310.~        -  (cohort 2) evaluate efficacy and safety of BK1310 using ActHIB® and Tetrabik as a~          control in healthy infants.~   "
43845|NCT02992912|"~     Although it is usually described as an immunosuppressive modality and not thought of as~     immunotherapy, there are new preclinical evidences suggesting that high-dose ionizing~     irradiation (IR) results in direct tumour cell death and augments tumour-specific immunity,~     which enhances tumour control both locally and distantly. Importantly, IR effects exceed the~     classical cytocidal properties by also causing phenotypic changes in the fraction of~     surviving cells, markedly enhancing their susceptibility to T cell-mediated elimination.~     However, not all IR-induced modifications of the tumour and its microenvironment favor immune~     rejection. The tumour microenvironment is populated by various types of inhibitory immune~     cells including Tregs, alternatively activated macrophages, and myeloid-derived suppression~     cells (MDSCs), which suppress T cell activation and promote tumour outgrowth. Chiang et al.~     showed the accumulation of pro-tumourigenic M2 macrophages in areas of hypoxia present in~     irradiated tumours. IR then may also induced responses that are inadequate to maintain~     antitumuor immunity.~      Close interaction between IR, T cells, and the PD-L1/PD-1 axis exsit and provide a basis for~     the rational design of combination therapy with immune modulators and radiotherapy. Deng et~     al. demonstrate that PD-L1 was upregulated in the tumour microenvironment after IR. Moreover,~     administration of anti-PD-L1 enhanced the efficacy of IR through a cytotoxic T cell-dependent~     mechanism. Concomitant with IR-mediated tumour regression, IR and anti-PD-L1 synergistically~     reduced the local accumulation of tumour-infiltrating MDSCs, which suppress T cells and alter~     the tumour immune microenvironment. Finally, activation of cytotoxic T cells with combination~     therapy mediated the reduction of MDSCs in tumours through the cytotoxic actions of TNF.~     Sagiv-Barfi et al, also demonstrated in 5 patients receiving atezolizumab and radiation~     therapy, at least stabilization of systemic progression in all patients and a RECIST partial~     response at systemic sites in 1 patient. Transient, grade 1-2 inflammatory adverse events~     (fevers, flu-like symptoms) occurred with no serious immune-related toxicities. Abscopal~     out-field effects of irradiation has also been described in addition to a reduction in~     circulating MDSCs in a melanoma patient treated with the anti CTLA-4 ipilimumab and~     radiotherapy.~      Lastly, recent evidence demonstrates that loco-regional curative treatment with stereotactic~     ablative radiotherapy (SABR) is a good alternative as compared with conventional 3D RT for~     patients with solid tumour, with durable remissions and a low toxicity profile. Many~     non-randomised studies have shown that SBRT for oligometastases is safe and effective, with~     local control rates of about 80%. Importantly, these studies also suggest that the natural~     history of the disease is changing, with 2-5 year progression-free survival of about 20%. For~     colorectal, non-small cell, and renal cell cancers, 1-year metastasis control rates ranged~     from 67 to 91%. Moreover, abscopal reponses in the setting of immune checkpoints inhibitors~     and radiotherapy combinations have been made in the setting of metastatic disease event in~     patients with extensive tumor burden. The goal of SABR is to deliver appropriate metastasis~     directed radiotherapy while minimizing exposure of surrounding normal tissues. Interestingly,~     the dose and fractionation employed modulate RT ability to synergize with immunotherapy.~     Vanpouille-Box et al, showed that immune response genes were differentially expressed in~     irradiated tumours by 8Gyx3 but not 20Gyx1. This highlight the interest of hypofractionated~     SABR acting as a in situ tumour vaccine.~      As hypofractionated SABR may, in addition to its good local control, increase the~     effectiveness of anti PD-L1, investigators aimed to investigate the efficacy and the~     tolerability of the combination of anti-PD-L1 antibody with SABR.~   "
43846|NCT02992899|"~     The tasks of the project are to map the potency and kinetics of the neurologic, autonomic~     peripheral, inflammatory, and behavioral responses to vagal nerve stimulation (VNS) vs. sham~     treatment, at baseline and in response to stressful traumatic scripts related to personal~     traumatic events, as well as a series of other stressors.~   "
43847|NCT02992886|"~     The aim of this multicenter phase II study is to evaluate the response rate, local control,~     disease-free survival and treatment-related toxicity of preoperative chemoradiation for~     intermediate or locally advanced rectal cancer in the fit elderly.~   "
43848|NCT02992873|"~     Sudden cardiac death is a major health problem in the western world. In Europe alone nearly~     300 000 patients are affected annually. The majority of victims suffering from an~     Out-of-Hospital Cardiac Arrest (OHCA have an initial cardiac rhythm that can be treated by~     means of defibrillation. In most emergency medical systems (EMS) time to defibrillation is~     too long and survival averages 10 %.However, when laymen operated Automated External~     Defibrillators (AEDs) are used within the first minutes, 7 out of 10 may survive.~      The aim of The Scandinavian AED and Mobile Bystander Activation (SAMBA) trial is to~     evaluate if a Mobile Phone Positioning system and a smartphone application will increase the~     proportions of patients with an attached Automated External Defibrillator (AED) before~     arrival of the Emergence Medical System (EMS). Mobile phone technology and a smartphone~     application will be used identify and recruit nearby CPR-trained lay people and automated~     external defibrillators (AEDs) to patients suffering out-of-hospital cardiac arrest (OHCA).~     The system is currently running in Stockholm Sweden and in the Gothenburg region.~   "
43849|NCT02992860|"~     The outcome of HMA-refractory patients with MDS or AML is dismal with a median survival of 5~     months after failure, representing a significant unmet medical need due to the very limited~     treatment options. In this context, a specific targeting of the leukemic stem cell (LSC)~     seems a promising option to selectively combat the leukemic progenitor cells. In fact, CD123~     is overexpressed in AML and MDS progenitors making it an attractive target for~     immunotherapy-based approaches. JNJ-56022473 is a promising compound that has been engineered~     with regard to this strategy and the current phase II trial has the aim to evaluate the~     overall hematological response rate at 3 months in HMA refractory/relapsed AML and MDS~     patients.~   "
43850|NCT02992847|"~     Several recent studies have shown an increase in the signal intensity of the unenhanced~     T1-weighted magnetic resonance images in the brain of patients with normal renal functions~     and a breakdown of the blood-brain barrier. This hyper-intensity was specifically related to~     an accumulation of gadolinium based contrast agent. These studies were mainly conducted in~     patients with primary or secondary brain tumor. Multiple sclerosis is a particular model~     since it involves patients with a break of the blood-brain barrier, a long life expectancy,~     and who received many injections of contrast enhancing agents. In this context, it appears~     fundamental to know whether contrast agents accumulate in the brain for this disease. The~     French Observatory of Multiple Sclerosis is particularly suited to test this hypothesis, with~     homogeneous MRI data over several centers in France, and optimized sequences of 3D-T1 without~     injection. The purpose of this study is to evaluate the accumulation of two commonly used~     gadolinium based contrast materials (Dotarem and Multihance) in patients with multiple~     sclerosis, who received at least 5 injection of exclusively one of these contrast material.~   "
43851|NCT02992834|"~     This study aims to evaluate the safety, efficacy and duration of response of CD19 Chimeric~     Antigen Receptor (CAR) redirected allogeneic T-cells in patients with chemotherapy-resistant~     or refractory CD19+ B cell lymphoma.~   "
43861|NCT02992704|"~     Chronic Hepatitis B carriers (normal LFTs and viral load < 2 x 10^4 IU/ml are not recommended~     to be treated by guidelines as they are at low risk for complications. However, it is unclear~     if treatment can enhance HBsAg loss which has been shown to be associated with significantly~     lower risk of complications compared to those without HBsAg loss. Consequently, this is a~     proof of concept study to determine the possibility of HBsAg loss in Chronic Hepatitis B~     carriers in a randomised open label clinical trial comparing no treatment to 24 weeks~     peg-interferon alpha 2a or 48 weeks peginterferon alpha 2a (randomised 1:1:1). The primary~     endpoint of HBsAg loss will be evaluated 24 weeks after the end of therapy for those on~     therapy and matched to an equivalent timepoint in the control arm. The sample size~     calculation is 30 patients in each arm for a 20% difference between any experimental arm and~     the control arm.~   "
43852|NCT02992821|"~     Among patients admitted with cerebral ischemia (stroke and transitory ischemic attack (TIA))~     it is important to reveal the underlying cause of the disease. In special it is important to~     reveal if carotid artery stenosis is present as such a finding will directly influence on~     treatment and follow-up.~      For the diagnosis of carotid artery stenosis due to atherosclerosis ultrasound examinations~     is the cornerstone, but computer tomography and magnetic resonance imaging may be better in~     some cases. Development of high quality pocket-sized ultrasound scanners has allowed for semi~     quantitatively bed-side assessment of the carotid arteries and the heart.~      The investigators aim to study the feasibility and reliability of bed-side assessment of the~     carotid arteries by pocket-sized ultrasound scanners in inexperienced hands and the clinical~     influence of this examination when performed by experienced users.~      The investigators hypothesize that a significant proportion of this patient population can be~     clarified bed-side by junior doctors with no need of further imaging procedures for the~     assessment of the carotid arteries and the heart.~   "
43853|NCT02992808|"~     In this study the investigators will try to discover whether there is a difference for any of~     the stimulation preparations - recombinant FSH + recombinant LH (pergoveris & luveris) vs.~     human menopausal gonadotropin (menopur) during GnRH-antagonist cycles in the meaning of~     androgenic hormones profile. The study question is whether using recombinant LH will result~     in different follicular hormonal milieu, serum endocrine profile or IVF outcomes than using~     highly purified urinary gonadotropins with hCG mimicking LH activity.~   "
43854|NCT02992795|"~     This is a prospective, non-blinded, matched control study of young athletes (ages 10-28 years~     old) in collegiate sports. The cohorts are defined in accordance to the athlete's exposure of~     injury. All subjects will complete a minimum of one recording based on their assigned cohort.~     Concussed athletes will complete an additional 3 weeks of follow-up recordings post injury.~     The symptomatic evaluation, physical examination, neurological baseline testing, and~     BrainPulse recordings will be entered in a database to determine clinical outcome and assess~     device utilization.~   "
43855|NCT02992782|"~     Women who have undergone breast cancer surgery may develop swelling of the arm on the side~     the breast cancer occurred. If the swelling becomes chronic it is called lymphedema. This~     study will examine the effect of a 12-week decongestive progressive resistance exercise with~     advanced compression on breast cancer related lymphedema. Our objective is to determine if~     breast cancer survivors are willing and able to wear advanced compression while exercising~     and if the combination will help to reduce their lymphedema. Twenty-four breast cancer~     survivors from Edmonton, Alberta will be enrolled in the one-year long study.~   "
43856|NCT02992769|"~     Axillary lymph node status is a vital prognostic factors in breast cancer patients and~     provides crucial information for making treatment decisions.This projective observational~     study is planned to identify risk factors for axillary metastases in breast cancer patients~     with axillary ultrasound and to construct a nomogram to predict the risk of axillary~     metastases in these patients.~   "
43857|NCT02992756|"~     Assisted reproduction patients candidates to an IVF/ICSI cycle with low follicular reserve:~     after at least one cycle of stimulation obtaining 0-4 oocytes.~      Improve the follicular response in patients with low response, increasing the number of~     follicles in subsequent cycles to treatment with growth factors.~   "
43858|NCT02992743|"~     This study is for men and women who have a type of sarcoma that has returned after being~     treated, or that cannot be surgically removed. The specific type of sarcoma is Myxoid / Round~     Cell Liposarcoma, also known as High Grade Myxoid Liposarcoma.~      In addition to this disease patients must also have the tissue type HLA-A*02:01, HLA-A*02:05~     or HLA-A*02:06, and a sample of tumor tissue must test positive for the NY-ESO-1 protein.~      The study treatment is made from some of the patient's own white blood cells called T cells.~     T cells are collected from the patient and sent to a laboratory to be genetically modified,~     with the aim that they will be able to destroy the cancer cells.~      Manufacturing the T cells takes about 1 month to complete. The T cells will be given back to~     the patient by an intravenous infusion. The purpose of this study is to test whether the T~     cells have an effect on the cancer and to test whether the treatment can be given safely to~     patients with this disease.~   "
43859|NCT02992730|"~     Breast cancer is the leading cancer diagnosed in women and the second cause of cancer death.~     Of all racial/ethnic groups in the US, Black women have the highest rate of breast cancer~     deaths. Two-thirds of Black breast cancer patients have estrogen receptor (ER) positive~     tumors that can be treated with adjuvant hormonal therapy. If taken for the full five years,~     this therapy has been shown to reduce mortality by 50%. However, ER positive Black women are~     more likely to die from their breast cancer as ER positive White women. Preliminary data~     suggest that non-adherence to adjuvant hormonal therapy could explain some of this disparity.~     To date, no study has systematically examined psychosocial, healthcare, and biological~     factors that predict adherence to hormonal therapy in Black women with breast cancer. To~     begin to fill this knowledge gap, Investigators will conduct a prospective cohort study of~     422 ER positive Black breast cancer patients recruited from health maintenance organizations~     (HMOs). Our primary outcome is adherence to therapy at 36 months post initiation. Specific~     aims are to: 1) Examine psychosocial factors (e.g. health beliefs, socio-cultural values,~     etc.) that predict adherence to hormonal therapy; 2) Identify clinical (e.g., side effects),~     and biological (e.g., stage, etc.) factors that predict adherence to hormonal therapy; and 3)~     Evaluate healthcare variables (e.g., communication, management of side effects, etc.) that~     predict adherence. Investigators will also explore the role of CYP2D6 genetic variations in~     adherence to hormonal therapy which is novel and will increase knowledge about this genetic~     factor in Blacks. The study is focused on the time-period (first 3 years) when women appear~     to be the most vulnerable to terminating treatment prematurely. A better understanding of~     predictors of adherence in Black women may help target interventions and ultimately improve~     potentially avoidable adverse breast cancer outcomes in this underserved group.~   "
43860|NCT02992717|"~     The 3D-CAM is a new 3-minute diagnostic assessment for Confusion Assessment Method-defined~     Delirium. The primary objective of this study is to translate the 3D-CAM into the German~     language, as well as to validate its use to detect postoperative delirium in the recovery~     room. The validation will be based on comparisons to the Nu-DESC (Nursing Delirium Screening~     Scale), CAM (Confusion Assessment Method), and DSM-5 criteria (Diagnostic and Statistical~     Manual of Mental Disorders).~   "
43862|NCT02992691|"~     The Dose response of three experimental toothpastes (test product 1, test product 2 and test~     product 3) to remove plaque after a single brushing, compared to a positive control and~     negative control dentifrice will be evaluated.~   "
43863|NCT02992678|"~     Between December 2016 and June 2017, 110 consecutive patients older than 18 years who are~     scheduled to undergo diagnostic or therapeutic ERCP at the Anhui Provincial Hospital will be~     recruited for the study. Patients were randomized using opaque, sealed envelopes containing~     random numbers assigning them to treat with pentoxifylline (pentoxifylline group) or Placebo~     (placebo group) for preventing ERCP pancreatitis.~   "
43868|NCT02992613|"~     Numerous studies have echoed the superior clinical outcomes of posterior-stabilized (PS)~     total knee arthroplasty compared to posterior cruciate-retaining (CR) total knee~     arthroplasty. The post-cam mechanism of posterior-stabilized (PS) total knee arthroplasty has~     been postulated to provide reproducible femoral rollback and increased flexion. However,~     posterior-stabilized (PS) total knee arthroplasty systems are purportedly limited due to~     several post-cam related problems, including post-cam dislocation, wear and breakage of post,~     and patellar clunk syndrome. Moreover, the post-cam mechanism requires additional bone~     resection and poses a risk for intercondylar fracture of the distal femur during box~     preparation. To overcome these issues, a fixed-bearing highly conforming ultra-congruent (UC)~     total knee arthroplasty was introduced.~      This study aims to compare the clinical results of Ultra-Congruent(UC) and~     posterior-stabilized(PS) insert in bilateral total knee arthroplasty.~   "
43869|NCT02992600|"~     To study on the Postoperative Cognitive Dysfunction: Correlations With Olfactory Dysfunction~     and Related Gene Changes.To explore whether the olfactory dysfunction could be used as a~     predictor of POCD and to provide reference for POCD prevention, early detection and timely~     diagnosis and treatment.~   "
43870|NCT02992587|"~     Background:~      Over the past decades there have been seen an increase in life expectancy in Denmark. One of~     the consequences is that the patients who need heart surgery have a higher average age and~     some of these patients have a fragile physique that increases the risks of major surgery.~      In cardiac surgery, there are different types of scoring system for assessing the~     preoperative risk of death associated with surgery. Among them are EuroSCORE and STS systems~     the most used.~      This study evaluate the preoperative risk using the frailty score system, CAF (comprehensive~     assessment of frailty), based on an assessment of the patient's physical condition. If the~     patient has a lower than expected physical condition, the patient is frail. The assessment of~     the physical condition generated from questions about the patient's medical history and~     physical activity as well as performing less physical tests, consisting of strength, balance~     and walking speed.~      Purpose:~      A prospective observational study, who investigates how many of the patients who must undergo~     heart surgery, that is frail. Then compare the patients who are frail with non-frail patients~     in terms of complications, mortality and quality of life after the procedure. By use of CAF~     score the patients are scored frail or non-frail. There is planned a further study which~     compare degree of kidney injury in frail with non-frail patients. Our assumption is that~     patients which are frail, have an increased risk of complications and longer hospital stay,~     higher consumption of intensive days and more readmissions. Using frailty score in~     combination with the existing score systems EuroSCORE and STS score, are believed to be a~     better predictor of complications following heart surgery.~      Method:~      FICS study is a prospective observational study of patients undergoing cardiac surgery in the~     cardiothoracic department of Rigshospitalet. Planned to enroll 600 patients over a two year~     period. The study consists of various smaller physical test and questions. Which is used to~     assess whether the patient is frail and not frail.~      Postoperatively follow-up after 30 days with a phone call and after 12 months through danish~     data register. At the both follow-up times, data are collected on the somatic readmissions /~     diagnoses and vital status through the national register and review of relevant journal~     notes. Afterwards comparing complications and mortality.~      Who can enter:~      One patients can be included if the following criteria are met: Age> 65 years, Elective or~     subacute surgery, CABG (coronary artery bypass grafting),valve substitution or combination of~     these~      If one or more of the following criteria are met, the patient is not included in the study:~      Acute surgery, Clinical unstable, Severe neuropsychiatric impairment, Uncooperative~     (psychiatric diagnosis) and Re-operations.~      Side effects, risks and disadvantages:~      Today preoperative risk assessment are assessed by EuroSCORE. Introduction of CAF, frailty~     score will not expose patients to the risk or side effect, since the course or treatment does~     not change.~      Economy:~      There are considered that the study are economically justified, since hypothetically this~     would lead to fewer readmissions, fewer days in intensive care and shorter hospital.~      Acquisition:~      The patients will in this trial be over 65 years old and must have completed elective or~     subacute cardiac surgery. They will receive participant information and thus the opportunity~     to read about the study before the first appearance.~      At first appearance they meet our project assistant and get here verbal information about the~     study, where also questions can be answered. Subsequently, the patients will be asked to sign~     a consent form.~      Publication of test results / research ethics statement:~      The knowledge and results obtained through the survey will provide essential scientific~     information of significance for the future course and treatment of patients undergoing~     cardiac surgery with regard to the number of hospital days, intensive days and readmissions.~     Thus, the investigator believes that the study is appropriate and ethically~   "
43871|NCT02992574|"~     Postmastectomy radiotherapy (PMRT) is unequivocally beneficial in reducing the recurrences as~     well as improving survival in node positive breast cancer patients. PMRT for women with T1-T2~     tumors and negative axillary nodes is not generally warranted because of the presumed low~     risk of recurrence in this population as a whole. However, in the setting of multiple adverse~     prognostic factors, the recurrence risk approaches and in some cases surpasses the risk of~     recurrence documented for patients with one to three positive lymph nodes. Numerous~     retrospective series have reported the outcome and patterns of failure for post-mastectomy~     patients treated without radiation. Many of these series have analyzed several high risk~     factors which were predictive of loco-regional recurrence wherein the role of adjuvant~     post-mastectomy radiation can be considered. Some authors have used combinations of~     prognostic factors, such as age, tumour size, grade, receptor status, Her2neu status and~     lympho-vascular space invasion to define subgroups with more specific risks of loco-regional~     recurrence than single factors alone. The current trial hypothesizes that Post-mastectomy~     radiation in high risk, node negative early breast cancer patients decreases rates of~     loco-regional recurrence and improves disease free survival and propose to address the~     question in randomized setting.~   "
43872|NCT02992561|"~     Heightened levels of aggression are fuelling violent incidents at all levels, especially in~     post-war regions. Narrative Exposure Therapy for Forensic Offender Rehabilitation (FORNET)~     aims to address trauma symptoms along with reactive and instrumental/appetitive aggression to~     encounter the downward cycle of perpetration and enforce a sustainable (re-)integration into~     civil life. In the present study, the investigators provide an adapted version of FORNET to~     former combatants in the North Kivu, Eastern DR Congo. Structured baseline, 3 and 6 month~     follow up interviews will be administered to assess the main outcome measures recent violent~     acts and appetitive aggression.~   "
43873|NCT02992548|"~     Treatment using statin has been decreased the risk of cardiovascular events in pre-dialysis~     CKD population. Supplementation with omega-3 fatty acid (FA) lowers the risk of~     cardiovascular death in patients with myocardial infarction. This cardioprotective effect of~     omega-3 FA can be explained by anti-inflammatory, anti-oxidative, or anti-thrombotic effects.~     Statin such as pravastatin is also known to have anti-inflammatory and antioxidant~     properties, suggesting that statin may replace the cardioprotective effect of omega-3 fatty~     acids. Erythrocyte membrane oleic acid is significantly higher in patients with acute~     coronary syndrome than control subjects. The cardioprotective effect of omega-3 FA may also~     be related to decreased oleic acid content of erythrocyte membrane. There is no report about~     the effect of statin on FA including erythrocyte membrane oleic acid. As omega-3 FAs are~     recognized as therapeutic agents for reducing triglycerides, statin may affect on the~     erythrocyte membrane FA. Therefore, pravastatin supplementation can modify erythrocyte~     membrane FA contents including oleic acid in CKD patients.~   "
43874|NCT02992535|"~     Evaluate changes in tear film osmolarity and other DED signs/symptoms following treatment~     with IPL.~   "
43875|NCT02992522|"~     This phase I study studies the side effects and best dose of venetoclax and lenalidomide when~     given together with obinutuzumab in treating patients with B-cell non-Hodgkin lymphoma that~     has returned after a period of improvement or not responding to treatment. Monoclonal~     antibodies, such as obinutuzumab, may interfere with the ability of cancer cells to grow and~     spread. Venetoclax may stop the growth of cancer cells by blocking some of the enzymes needed~     for cell growth. Drugs used in chemotherapy, such as lenalidomide, work in different ways to~     stop the growth of cancer cells, either by killing the cells, by stopping them from dividing,~     or by stopping them from spreading. Giving obinutuzumab, venetoclax, and lenalidomide may~     work better in treating patients with B-cell non-Hodgkin lymphoma.~   "
43876|NCT02992509|"~     The pilot study is intended to show the efficacy of intravesical electrical stimulation in~     treating overactive bladder with or without frequency and/or urgency urinary incontinence.~   "
43877|NCT02992496|"~     The purpose of this double-blind, controlled, randomized study is to investigate the~     antidepressant efficacy of oral ketamine treatment in patients suffering from a major~     depressive episode.~   "
43878|NCT02992483|"~     The purpose of this first in human study is to assess safety, tolerability, PK and~     preliminary clinical activity and to estimate the MTD(s)/RDE(s) of MIK665 (also referred as~     S64315) as single agent administered intravenously (i.v.) in adult patients with refractory~     or relapsed lymphoma or multiple myeloma.~   "
43879|NCT02992470|"~     This study aimed to observe whether a hydrolyzed oyster extract improves liver health in~     participants whose alanine transaminase (ALT) levels are1-3 fold above the normal. A total of~     96 participants will be randomly allocated to active (oyster) or placebo group (1:1). Each~     group will receive 750 mg of oyster extract or placebo per day for 8 weeks. Primary outcome~     will be the change in ALT level and secondary outcomes will be; (1) ratios of participants~     with normal ALT, aspartate aminotransferase (AST), and gamma-glutamyl transferase (GGT); (2)~     the change in serum bilirubin; (3) the change in multi-dimensional fatigue inventory; (4) the~     changes in serum lipids; (5) the changes in antioxidant enzymes.~   "
43880|NCT02992457|"~     Egypt has the highest prevalence of hepatitis C virus (HCV) in the world, estimated~     nationally at 14.7%. Genotype 4 (and subtype 4a in particular) dominates the HCV epidemic in~     Egypt. For decades the antiviral therapy of chronic HCV infection was based on the~     administration of Interferon(IFN), initially alone and then in combination with Ribavirin~     (RBV), but this regimen was effective in only 50% of patients with genotype 1, with~     significant side effects.~   "
43881|NCT02992444|"~     This study investigates the impact real output has on peristomal skin covered by an adhesive~   "
43882|NCT02992431|"~     In the aging population, the prevalence of chronic diseases and multimorbidity has become~     common. Therefore, the planning and coordination of care have become more important. However,~     it is not known what kind of treatment plan should be and what kind of patients would benefit~     most of it.~      This research focuses on the participatory patient care planning in primary health care. In~     general, the participatory patient care planning (PPCP) aims to engage patients in self-care,~     to improve the collaboration between patients and professionals and to improve the use of~     resources. The present study investigates the feasibility and effectiveness of the PPCP.~      The specific research questions of the present study are: Does the PPCP have an impact on the~     patient's quality of life? Does the PPCP improve the quality of care in management of chronic~     diseases? Does the PPCP improve patient's commitment with self-care? Does the PPCP impact on~     the use of health care services? The data consists of people aged at least 18 years living in~     the municipality of Siilinjärvi with diabetes, coronary heart disease or hypertension and who~     are recorded in in Siilinjärvi Health Care Center electronic patient record. The~     participating patients are recruited from those who contacts SiiIinjärvi Health Care Center~     in order to have a follow-up visit because of the treatment of their disease. This study aims~     to recruit 700 patients.~      The participants are allocated into the intervention group and into the control group~     receiving usual care. Intervention consists of the PPCP. This includes the patient activation~     questionnaire form, a visit to the nurse who conducts the measurements (blood pressure, waist~     measurement, weight and length) and a visit to the general practitioner who discusses and~     agrees with the patient about the treatment goals and follow-up resulting in the written~     PPCP.~      The main out-come measures are the quality of health related life measured with the 15D; the~     level of patient's activity in self-care with the Patient Activation Measurement (PAM); life~     satisfaction, self-rated health, a reduction in productivity with the Work Productivity and~     Activity Impairment Questionnaire (WPAI: GH), and the disease specific measures (blood~     pressure, HbA1C, LDL-cholesterol, body mass index and waist measurement). In addition, pain~     intensity and interference (NRS 0-10), mood (BDI-21), the number of visits and phone calls~     and referrals are measured.~   "
43883|NCT02992418|"~     The aim of the study is investigate the immunogenicity and safety of CYD dengue vaccine and~     Tdap vaccine when both vaccines are administered concomitantly or sequentially.~      Primary Objectives:~        -  To demonstrate the non-inferiority of the humoral immune response to the Tdap booster~          dose concomitantly administered with the first dose of CYD dengue vaccine as compared to~          sequential administration, measured 28 days after Tdap booster dose~        -  To demonstrate the non-inferiority of the humoral immune response to the first dose of~          CYD dengue vaccine concomitantly administered with Tdap as compared to sequential~          administration, measured 28 days after the first dose of CYD dengue vaccine.~      Secondary Objectives:~        -  To demonstrate the non-inferiority of the humoral immune response of 3 doses of CYD~          dengue vaccine with the first dose concomitantly administered with Tdap as compared to~          sequential administration, measured 28 days after the third dose of CYD dengue vaccine.~        -  To describe the humoral immune response at baseline and 28 days after the first and~          third doses of CYD dengue vaccine, in each and any group.~        -  To describe the humoral immune response of Tdap vaccine at baseline and 28 days after~          concomitant administration with the first dose of CYD dengue vaccine as compared to the~          sequential administration, in each and any group.~        -  To describe the safety of the CYD dengue vaccine and of the Tdap booster dose after each~          and any injection in each group.~   "
43884|NCT02992405|"~     The FOCUS program (study treatment) is an established evidence-based intervention whose~     redesign for families and couples dealing with serious and chronic illnesses will provide a~     creative and promising supplement to the existing support services at Cedars-Sinai Medical~     Center. All participants will receive the 10-weeks of 75-minute weekly study treatment, but~     will be split into two groups, the immediate treatment group and the wait list treatment~     group, who will receive the study treatment after the immediate 10 weeks of treatment is~     completed.~   "
43885|NCT02992392|"~     With the potential to address evaporative dry eye, Liposic and Tears Naturale Forte have been~     developed in which phospholipid liposomes are delivered to the tear film via the surface of~     the closed eyelid. This study compare the effects of Liposic and Tears Naturale Forte~     application on the lipid and stability of the tear film in dry eye patients.~   "
43886|NCT02992379|"~     To evaluate the effectiveness of the stabilizing splint versus the pivot splint as jaw~     exercise together with stabilizing splints for treatment of TMJ anterior disc displacement~     without reduction~   "
43887|NCT02992366|"~     To evaluate the clinical and radiographic outcomes of socket shield technique compared with~     conventional immediate implant placement.~   "
43888|NCT02992353|"~     In china, the incidence and death rate of lung cancer is 48.32 per 100 000 person-years and~     39.27 per 100 000 person-years, respectively, the highest in malignant tumor. Surgical~     operation is still main treatment means to resectable NSCLC. VATS pulmonary resection is~     performed in clinical operation with the aim of decreasing postoperative complications~     morbidity. The mechanisms may be due to minimize the inflammation reaction to surgical~     injury. There are some trials regarding two-port VATS versus three-port VATS versus four-port~     VATS or single-port VATS versus three-port VATS. However, there is no prospective randomised~     controlled trial regarding Single-port versus two-port versus three-port video assisted~     thoracoscopic pulmonary resection on NSCLC. So, we hope to demonstrate that single-port and~     two-port VATS were feasible and safe through the trial, and we hope the results of our study~     will provide a high level of clinical evidence for choosing the best operative approach in~     VATS.~   "
43889|NCT02992340|"~     The study intends to evaluate the objectives in patients with advanced or metastatic biliary~     tract cancer who have not received systemic therapy for advanced/metastatic disease.~      Primary Objectives:~      Phase 1B • To determine the maximum tolerated dose (MTD), as determined by dose-limiting~     toxicities (DLTs), and to characterise the safety profile of Varlitinib in combination with~     Gemcitabine and Cisplatin.~      Phase 2~      • To compare the efficacy of Varlitinib in combination with Gemcitabine and Cisplatin to~     placebo in combination with Gemcitabine and Cisplatin as measured by progression-free~     survival (based on RECIST v1.1).~   "
43890|NCT02992327|"~     The overall research aim of this pilot study is to determine if the structural brain protein~     calpain-cleaved αII-spectrin N-terminal fragment (SNTF) can be used as a blood biomarker to~     accurately identify patients who will have more severe symptoms and reduced neurocognitive~     functioning after sustaining a concussion. Concussion is also referred to as mild traumatic~     brain injury (mTBI) in the literature. Both terms will be used interchangeably throughout~     this application.~   "
43891|NCT02992314|"~     Patients taking chemotherapeutic agents often do not comply well with their dosing regiment~     since many of these medications cause a metallic taste in the mouth. The primary intent is to~     determine the effectiveness of the oral rinse in reducing the metallic taste in the mouth~     associated with various chemotherapeutic agents. This clinical study a randomized,~     double-blind, single-treatment, parallel design with a placebo as the control. The duration~     of the trial will be 1 month.~   "
43892|NCT02992301|"~     Aim 1: To determine whether therapy with Alirocumab, compared to pre-treatment, will~     effectively improve carotid atherosclerotic plaque characteristics by reducing Ktrans and~     LRNC size. To achieve this goal, we will (a) enroll 30 subjects who are intolerant to high~     intensity statin therapy and only able to tolerate low potency statin or low weekly dose of~     high potency statin and have LDL-C ≥70 mg/dl; (b) initiate alirocumab at 150mg subcutaneously~     injection every 2 weeks; (c) perform carotid DCE-MRI scans at baseline, 3, 6 and 12 months;~     (d) perform quantitative analysis for vascular inflammation and plaque LRNC volume and other~     plaque characteristics; (e) compare vascular inflammation and LRNC volume between pre- and~     post-alirocumab at 3, 6 and 12 months.~      Aim 2: To examine associations between reductions in atherogenic lipids (LDL-C, Lp(a),~     non-HDL-C) and changes in atherosclerotic plaque characteristics. To achieve this goal, we~     will (a) perform laboratory assessments of lipids, lipoproteins and apo-lipoproteins at~     baseline and during the study; (b) compare lipids, lipoproteins and apo-lipoproteins levels~     between pre- and post-alirocumab; (c) correlate reductions in atherogenic lipids with changes~     atherosclerotic plaque characteristics.~   "
43893|NCT02992288|"~     The objective of the study is to find the optimal dose of once daily oral neladenoson~     bialanate (BAY 1067197) when given in addition to standard therapy for heart failure with~     reduced ejection fraction (HFrEF).~   "
43894|NCT02992275|"~     This study will examine the addition of neuromuscular electrical stimulation (NMES) on the~     hip abductors during strength training and a fall prevention program for improving muscle~     strength and improving balance. All individuals in this study will receive NMES to their hip~     abductors and will participate in a fall reduction program.~   "
43895|NCT02992262|"~     Pediatric emergency department (PED) physicians frequently encounter children with symptoms~     that warrant evaluation of the optic disc for suspected increased intracranial pressure (ICP)~     such as headache, blurred vision, recurrent vomiting etc. Fundoscopic examination, by the PED~     physician, is considered an essential modality for assessment of the optic disc and the~     diagnosis of papilledema. Obtaining good visualization of the optic disc requires patient~     compliance, the ability to open the eyelids, the absence of opacities in the ocular media and~     a sufficiently large pupillary aperture. Hence, different levels of PED physician training,~     lack of cooperation, significant ocular or periorbital trauma, contraindications to mydriasis~     and severe photophobia may hinder direct fundoscopic evaluation.~      In the investigators' PED, children requiring fundoscopy are sent to a formal ophthalmologic~     examination. The investigators aim to evaluate the yield of optic disc height as measured~     with ocular point of care ultrasound to detect optic disc swelling in comparison to~     ophthalmologic examination as the gold standard.~   "
43896|NCT02992249|"~     This is a prospective uncontrolled observational study to evaluate clinical outcomes~     following use of the ReCell Autologous Cell Harvesting Device (ReCell) as an adjunct for~     closure (re-epithelialization) as a treatment of life-threatening wounds requiring grafting~     for closure, and associated skin graft donor sites, in patients who lack adequate available~     skin to harvest for conventional grafting. Treatment with the ReCell device may be performed~     as part of a single operative procedure, or multiple staged procedures as deemed clinically~     necessary. Adverse events associated with the use of the ReCell device/cell suspension will~     be documented. Subjects will be followed for 1 year following ReCell treatment.~   "
43897|NCT02992236|"~     Analysis of the effect of the NO-Synthase inhibitor VAS203 (6 hours infusion of 10 mg/kg) on~     renal function and perfusion in 16 healthy subjects.~   "
43898|NCT02992223|"~     Evaluate if Y90 Ibritumomab Tiuxetan Radioimmunotherapy in addition to standard high dose~     chemotherapy followed by autologous stem cell transplant could improve prognosis in patients~     affected by relapsed/refractory aggressive non Hodgkin lymphoma~   "
43899|NCT02992210|"~     Patients with refractory and/or recurrent solid tumor have poor prognosis despite complex~     multimodel therapy and therefore, novel approaches are urgently needed. The investigators are~     attempt to treat these diseases using T cells genetically modified with a 4th generation~     lentiviral chimeric antigen receptor (4SCAR fused with an inducible apoptotic caspase 9~     domain) targeting GD2 (4SCAR-GD2). The 4SCAR-GD2-modified T cells can recognize and kill~     tumor cells through the recognition of GD2, a surface protein expressed at high levels on~     many types of tumors but not on normal tissues. This study will evaluate the side effects and~     effective doses of 4SCAR-GD2 T cells in treating refractory and/or recurrent tumors.~   "
43900|NCT02992197|"~     Rotavirus is the leading cause of diarrhea in children worldwide. Oral rotavirus vaccines~     work remarkably well in high-income countries, but for unclear reasons they underperform in~     low-income countries. A double-blind, randomized control trial will be performed to evaluate~     whether using a higher dose of a currently licensed vaccine (Rotarix, GlaxoSmithKline) can~     improve immune responses among infants in Dhaka, Bangladesh.~      Infants will be randomized 1:1 to receive either a standard or a double dose of Rotarix at 6~     and 10 weeks of life. Infants will be assessed for fecal vaccine shedding and serum~     rotavirus-specific IgA responses to determine vaccine immunogenicity.~   "
43901|NCT02992184|"~     The principal objective is to assess the diagnostic accuracy of the PoC assay (Genedrive,~     Epistem) to detect HCV RNA against the reference standard of commercial real-time polymerase~     chain reaction (RT-PCR) assay (RealTime HCV, Abbott) using stored heparinized plasma from~     patients with chronic hepatitis C and non-infected controls.~   "
43902|NCT02992171|"~     This study seeks to develop and pilot-test an oncology nurse-led care management intervention~     to meet the primary palliative care needs of patients with advanced hematologic malignancies.~   "
43903|NCT02992158|"~     The goal of this project is to train community mental health therapists in behavioral~     activation (BA) treatment for major depressive disorder and then to conduct a study examining~     the feasibility of evaluating the effectiveness of BA in this setting.~   "
43904|NCT02992145|"~     This study aims to compare between androgens level (serum total and free testosterone) in~     women with preeclampsia and normal ones in the third trimester of pregnancy (28-40 weeks).~   "
43906|NCT02992119|"~     Targeted malaria elimination (TME), which comprises appropriate case management by village~     health workers, vector control and mass drug administration, is currently being implemented~     through pilot projects in selected villages in the Greater Mekong Subregion (GMS) and the~     scale-up of the intervention to the regional level are underway. Based on mathematical~     modelling, extending the post-TME parasitaemia-free period in the majority of villagers for~     as short as 200 days will substantially increase the chances of achieving the interruption of~     malaria transmission. Immunogenicity of RTS,S is greater in older children, and the short~     term malaria protective effect is stronger than the overall effect assessed over 1-2 years.~     Addition of mass RTS,S/AS01E vaccination to the TME arsenal could provide this much needed~     additional protection.~      Currently there are no safety and immunogenicity data for the use of RTS,S/AS01 in Asian~     populations. This trial will generate the required data for the use of this vaccine in Asian~     populations. For integration with the current TME activities, which provide mass drug~     administrations at months M0, M1, and M2, it would be most efficient and practical to provide~     the vaccine at the same intervals. To address a two round intervention (M0, M2) where a three~     round intervention is not feasible, one study arm will look at the immune response generated~     by only two doses of vaccine and antimalarial medications. Recent evidence suggests that a~     vaccination schedule which includes a fractional dose of RTS,S/AS01 (1/5th of the standard~     dose) could be similarly or more protective than a schedule with three standard full doses,~     while requiring less vaccine and resources. The trial therefore includes study arms which~     will assess the safety and immunogenicity of fractional dose schedules.~      Each participant will be randomized into one of the following study arms in a ratio of~     20:20:30:30:30:30:30, as follows:~        -  RTS,S/AS01B Fractional dose group (Group 1)~        -  Double RTS,S /AS01E Fractional dose group (Group 2)~        -  RTS,S/AS01E Standard dose group (Group 3)~        -  RTS,S/AS01E + DHA-PIP+PQ Standard dose group (Group 4)~        -  RTS,S/AS01E Fractional dose group (Group 5)~        -  RTS,S/AS01E + DHA-PIP+PQ Fractional dose group (Group 6)~        -  RTS,S/AS01E + DHA-PIP+PQ Fractional two-dose group (Group 7)~   "
43907|NCT02992106|"~     The rising worldwide prevalence of obesity and its subsequently rising incidence of~     concommitant diseases as diabetes and cardiovascular events impose a defiant obstacle for the~     health care and associated health care costs of future generations. Obese pregnant women are~     a growing population of interest because their offspring is at risk for childhood obesity, an~     adverse metabolic and inflammatory profile and possible endothelial dysfunction. However,~     strong evidence is still lacking regarding the hypotheses on the early origin of these~     long-term health consequences.~      Consequently there is no comprehensive data available on the contribution of changing~     maternal weight through lifestyle interventions or bariatric surgery and an eventual adverse~     metabolic and endothelial programming of the offspring.~      The investigators of this study want to provide additional data on the body composition,~     metabolic and inflammatory state as well as endothelial function of children of obese~     pregnant women women and compare the outcome with children born from normal weight women.~     Furthermore, the investigators of this study will stratify the obese pregnant women into 3~     groups: women who did not underwent an intervention, women who underwent a weight changing~     intervention during pregnancy e.g. diet or lifestyle intervention and women who underwent~     bariatric surgery before pregnancy. The overall aim of the study is to prove that in all the~     diverse groups of participating children, except the control group, there will be a certain~     grade of endothelial dysfunction, even if there was a normalization of weight, insulin~     sensitivity and inflammation before conception or delivery in the mother.~   "
43908|NCT02992093|"~     The type-2 diabetes mellitus（T2DM）, metabolic syndrome, cardiovascular disease complications~     induced by polycystic ovary syndrome(PCOS) with insulin resistance(IR）, which become serious~     threat to public health. In this observational study, obese patients with PCOS,nonobese~     patients with PCOS, PCOS patients with impaired glucose tolerance（IGT）, PCOS patients with~     type-2 diabetes mellitus（T2DM）, and healthy volunteers would enrolled into this study,~     through the Liquid Chromatography-Mass Spectrometry coupled to Mass Spectrometry（~     LC-MS/MS）and Rapid Resolution Liquid Chromatography（RRLC） and Quadrupole Linear~     Trap（QTRAP）Mass Spectrometry coupled to Mass Spectrometry （MS/MS）analysis of serum samples~     collected from PCOS patients and healthy volunteers to screen the biomarker of diagnosis for~     PCOS with insulin resistance, to explore the correlation between traditional chinese medicine~     （TCM） syndrome（phlegm, kidney yin deficiency, kidney yang deficiency, qi stagnation and blood~     stasis，dampness-heat of liver channel）and metabolites of PCOS.~   "
43909|NCT02992080|"~     The aim of our study is to assess miRNAs expression profiles in the circuling blood of~     patients with cystic fibrosis and highlight signatures that could reflect the pulmonary~     status of patients~   "
43910|NCT02992067|"~     To establish a predicting system on axillary lymph node metastasis based on peripheral blood~     CK19mRNA and contrast-enhanced ultrasound.~   "
43911|NCT02992054|"~     Randomized controlled trial for assessing the effects resulting from an innovative~     occupational program using new technologies (KODRO) on nursing home residents' quality of~     life~      Context : improving quality of life (QOL) for the nursing homes residents (NHR) is a national~     priority (2010 report from French ANESM).~   "
43912|NCT02992041|"~     The purpose of this phase 2 study is to evaluate the efficacy and safety of an analgesic drug~     candidate, VVZ-149 Injections. The study is designed as randomized, double-blind, parallel,~     placebo-controlled study.~   "
43913|NCT02992028|"~     1. Treatment of rotator cuff tear The rotator cuff tear is the most demanding part of the~          shoulder surgery. Rotator cuff degeneration is thought to be the largest cause of~          rotator cuff tear.~           As the field of shoulder surgery evolves, the diagnosis and surgical treatment of the~          rotator cuff tear was increased. Repair and reconstruction of the rotator cuff tear~          annually more than 300,000 have been performed according to US statistics.~           Rotator cuff repair is a successful procedure, both objectively and subjectively, with~          regard to pain relief and functional outcome.~        2. postoperative pain management after rotator cuff repair Shoulder surgeries are~          associated with a level of postoperative pain requiring opioid use for several days. The~          opioid requirements after shoulder surgery have been reported to be similar to those~          required after gastrectomy or thoracotomy, which might cause several opioid-related side~          effects, such as nausea and vomiting, pruritus, urinary distention, and constipation.~          Although the introduction of arthroscopy has reduced postoperative pain, a considerable~          proportion of patients suffer from moderate to severe acute postoperative pain, as its~          benefit is typically apparent after a few days. Consequently, proactive pain control is~          also required during the first 24-48 h after arthroscopic shoulder surgeries, just like~          in open surgeries. Adequate pain management during the immediate postoperative period is~          not only important for patient satisfaction and well-being, but also for facilitating~          postoperative rehabilitation and preventing persistent postsurgical pain.~      Recently preoperative intravenous vitamin C has shown to increase the analgesic effect after~     otorhinolaryngologic surgery and thoracic surgery. Vitamin C is a water-soluble and known to~     have anti oxidant action, and fewer side effects.~      However, there is no report about the analgesic effect of vitamin C after arthroscopic~     rotator cuff repair.~      The purpose of this trial was to compare the effects of a intravenous vitamin C injection on~     postoperative pain and opioid consumption versus non-treated group after arthroscopic rotator~     cuff repair.~   "
43925|NCT02991872|"~     The purpose of this study is to evaluate the long-term persistence of immune responses~     approximately 5 years or more after simulated rabies post-exposure prophylaxis provided in~     2012 according to Essen (1-1-1-1-1) or Zagreb (2-1-1) intramuscular (IM) regimens in the~     subset of subjects who participated in the parent study (V49_24 [NCT01680016]) who were aged~     ≥6 and ≤17 years at the time of enrollment.~      This study is aimed to respond to a post-marketing commitment by the China Food and Drug~     Administration (CFDA) requested at the time of the renewal of the purified chicken-embryo~     cell rabies vaccine license in China, granted in August 2015.~   "
43914|NCT02992015|"~     Diffuse Intrinsic Pontine Glioma (DIPG) is an aggressive childhood brain tumor that, despite~     many past clinical trials, has never been shown to respond to chemotherapy. Radiation therapy~     (RT) is effective in extending life but is not curative; median overall survival is 11~     months. It is still unclear why the hundreds of clinical trials involving chemotherapy of~     DIPG have failed to demonstrate any activity against the tumor. Given that many agents tried~     in clinical trials cross the blood brain barrier (BBB), it is possible that there are factors~     specific to DIPG and its location that prevent adequate drug penetration. Gemcitabine has~     been selected for this study because there is strong evidence of DIPG cell line inhibition in~     vitro and good BBB penetration. Furthermore, pediatric dosing and toxicity has been~     established in prior studies of children with relapsed solid tumors and leukemia.~      The primary aim of this study is to determine the presence of gemcitabine in childhood DIPG~     tissue after systemic treatment with the drug. The secondary aim is to quantify the~     intratumoral gemcitabine concentration after systemic treatment.~      Participants in this study will be given a one time IV dose of gemcitabine prior to having~     standard of care surgery. During surgery biopsies will be obtained for clinical and research~     purposes along with a blood sample. Because patients will be undergoing this biopsy as part~     of their standard of care therapy here at Children's Hospital Colorado, this is an optimal~     time to obtain a tumor biopsy for this study. The biopsy will serve to see if the study drug~     is penetrating the tumor. Patients will then enter a follow-up period for 30 days post~     surgery.~   "
43915|NCT02992002|"~     The study investigates the influence of a clinically indicated fluid challenge on~     end-expiratory lung impedance, assessed by electrical impedance tomography (EIT). EIT data~     will be collected before, during and after infusion of 500 ml of crystalloid solution in~     mechanically ventilated patients on an operative intensive care unit.~   "
43916|NCT02991989|"~     Muscle size declines at around 0.5-1% per year after 50 years of age, with muscle strength~     declining up to twice as fast as muscle size. This may eventually lead to loss of~     independence if tasks of daily living become too strenuous to be performed safely. Exercise~     is recognized as a safe and effective means to counteract muscle loss during aging, however~     access to gym equipment may be logistically challenging or unpalatable to older adults. This~     research is designed to investigate the effect of 28 days of home-based leg exercise that~     doesn't require exercise equipment or supervision (exercise snacking), accompanied with a~     daily protein supplement in the form of commercially available yogurt, on the skeletal muscle~     health (i.e. function and size) of independent, community-dwelling older adults. To achieve~     this, two groups will be compared; one group will undertake exercise snacking and consume a~     150 g yogurt with the breakfast meal for four weeks, with the second group only receiving the~     daily yogurt with no exercise snacking.~   "
43917|NCT02991976|"~     This study evaluates effects of high inspiratory oxygen on cerebral tissue oxygenation and~     patient recovery after carotid endarterectomy. Two group of patient undergoing to carotid~     with total intravenous anaesthesia will receive either 35% inspired oxygen or 100% oxygen.~   "
43918|NCT02991963|"~     This is an observational study (case-control study) aiming to identify risk factors for~     malaria infection in health centers or malaria posts or district hospitals in Buntharik~     District and Nachalui District, Ubon Ratchathani Province, Thailand.~      This study expects to recruit 330 cases (malaria positive) and 330 control (negative cases)~     subject. One-to-one matching of cases (malaria positive) and controls (malaria negative) will~     be done at each study site.~      CASE (Malaria positive) subject will go through the following;~        1. Enrollment visit (Day 0)~           1.1 Blood collection of three dried blood spots, and malaria slide. In district~          hospitals in individuals >14 kg: additional 10ml venous blood will be collected.~           1.2 A survey questionnaire which includes patient demographics, information on malaria~          treatment, bed net use and possible risk factors for acquiring malaria, as well as~          questions about their travel and usage of mobile phones will be administered.~        2. Follow up visits (if fever plus Day 42 (+/-3))~      2.1 Blood collection of three dried blood spots and malaria slide. In district hospitals:~     additional 0.5ml venous blood will be collected.~      2.2 Short survey questionnaire including questions on symptoms, travel and possible risk~     behaviors since enrollment will be administered.~      CONTROL (Malaria negative) subject will go through the following;~        1. Enrollment visit (Day 0)~           1.1 Blood collection to confirm negative malaria slide. In district hospitals:~          additional 0.5ml venous blood will be collected.~           1.2 A survey questionnaire including patient demographics, information on any recent~          malaria treatment they may have taken, bed net use and possible risk factors for~          acquiring malaria, as well as questions about their travel and usage of mobile phones~          will be administered.~        2. Follow up visit: No follow up visit~   "
43919|NCT02991950|"~     Prospective randomized study of patients with infertility candidates to Assisted~     ReproductiveTechniques (ART), screened for all inclusion and exclusion criteria, submitted to~     ART cycle with or without low molecular weight heparin (LMWH) administration. Aims of the~     study are to evaluate, primarily, pregnancy rate/embryo transfer, secondarily take home~     babies/embryo transfer, implantation rate, and the role of thrombophilic factors~   "
43920|NCT02991937|"~     This is a randomized controlled trial of 190 subjects comparing non-operative management with~     antibiotics to surgical management of uncomplicated acute appendicitis. The hypothesis is~     that antibiotics are not worse than surgery for the treatment of uncomplicated appendicitis~     in children. The primary outcome will be survey scores on the Pediatric Quality of Life~     Inventory (PedsQL) Generic Core Scale Parent-proxy report. Secondary outcomes will include~     child scores on the PedsQL; length of stay; immediate, 1-week, 2-week, 30-day, and 60-day~     success of non-operative management; readmission rates for both groups; and long-term~     complications over one year.~   "
43921|NCT02991924|"~     The purpose of this study is to investigate risk factors for mediastinal lymph node~     metastasis in potentially operable non-small cell lung cancer in order to find indications~     for endoscopic mediastinal staging. Chest CT, integrated PET/CT, and endobronchial ultrasound~     guided transbronchial needle aspiration (EBUS-TBNA) +/- endoscopic ultrasound with~     bronchoscope-guided fine needle aspiration (EUS-B-FNA) are performed for mediastinal staging.~     CT and PET/CT findings, histologic types and other risk factors will be analyzed. The~     investigators develop the prediction method for mediastinal metastasis.~   "
43922|NCT02991911|"~     The purpose of this study is to assess the safety and tolerability, describe the~     dose-limiting toxicities (DLTs), and determine the maximum tolerated dose (MTD) or maximum~     administered dose (MAD [in the absence of establishing the MTD]) for single agent MEDI3726 in~     subjects with mCRPC who have received prior treatment with abiraterone or enzalutamide, with~     or without a prior taxane-based chemotherapy in the mCRPC setting~   "
43923|NCT02991898|"~     This is a single center pilot study of a non-myeloablative umbilical cord blood transplant~     for the treatment of a hematological malignancy with a single infusion of T regulatory (Treg)~     given shortly after UCB transplantation.~   "
43924|NCT02991885|"~     The aim of this study is to confirm safety and tolerability of incremental doses of HAL-MPE1~     subcutaneous immunotherapy (SCIT) in peanut allergic adults, and subsequently assess the~     safety and tolerability in adolescents and children with peanut allergy.~   "
43926|NCT02991859|"~     This is a randomized, placebo-controlled, 2-period crossover, escalating repeat dose study,~     aiming to investigate whether higher potency of different inhaled corticosteroid confers an~     improvement in the topical efficacy to systemic activity ratio in asthmatic subjects. It will~     compare the dose response for topical efficacy via airway responsiveness (to~     adenosine-5'-monophosphate [AMP] challenge), and the dose response for systemic activity via~     24 hour plasma cortisol suppression, and thereby compare the relative therapeutic index, for~     the following inhaled corticosteroids: fluticasone furoate (FF), fluticasone propionate (FP)~     and budesonide (BUD).~      There will be a screening visit 7-28 days before the first dose of study treatment, and a~     minimum 4-day run-in period before the first dose of study treatment. Subjects will be~     randomized to one of 12 treatment sequences, and will have two treatment periods, each~     comprising 5 consecutive 7-day phases of escalating doses of either FF, FP, BUD or placebo.~     There will be a 25- to 42-day washout period between treatment periods. The study duration~     for each subject will be approximately 22 weeks including the follow-up period.~   "
43927|NCT02991846|"~     Prospective, observational, multicentre, spontaneous, non-interventional study This study~     will evaluate all consecutive patients who develop chronic graft-versus-host disease,~     reported by the Italian GITMO centers according to a standardized Web platform for real-time,~     onsite data collection. The platform for data collection will be based on a software~     prototype developed by the Clinica di Ematologia di Ancona Transplant Center for the~     management of patients with chronic graft-versus-host disease. This software has been~     integrated with algorithms that automatically determine: severity of chronic~     graft-versus-host disease and overall response according to the 2015 NIH consensus criteria.~   "
43928|NCT02991833|"~     The aim of this randomized controlled clinical trial, prospective study is to developing a~     new incontinece care product for containing the fecal incontinence and to examine the effect~     of this new product on prevention of perineal dermatitis.~   "
43929|NCT02991820|"~     This study will compare the CMAC and Glidescope videolaryngoscopes (VL) to traditional direct~     laryngoscopy (DL) using either a Miller or Macintosh laryngoscope by studying the performance~     of users. This will involve the use of an intubating pediatric manikin to assess various~     aspects of endotracheal intubation by experienced and inexperienced users.~   "
43930|NCT02991807|"~     Phosphatase and TENsin homolog (PTEN) gene germline mutations are associated with a spectrum~     of clinical manifestations characterized by neurocognitive deficits, intellectual disability,~     autism symptomatology, skin lesions, macrocephaly, hamartomatous overgrowth of tissues, and~     an increased risk of cancers. Investigators are conducting research to evaluate the potential~     safety and efficacy of RAD001 (everolimus) in this patient population, and the potential~     neurocognitive benefits from treatment with RAD001 or placebo for a six month period. The~     investigators hope this trial will lead to a better understanding of PTEN and to new forms of~     treatment that may benefit children and adults with PTEN in the future.~   "
43931|NCT02991794|"~     The aim of the study is collecting clinical data on the learning curve of different surgeons~     using the EinsteinVision® 3D visualization system in laparoscopic radical prostatectomies.~   "
43932|NCT02991781|"~     This study will develop and experimentally test the efficiency of a neurofeedback training~     protocol vs. varenicline use for smoking cessation.~   "
43933|NCT02991768|"~     The purpose of this study is to learn if using a Entocort (budesonide) to treat diarrhea will~     be effective and safe for kidney transplant patients, allowing them to continue with MPA~     medication.~   "
43934|NCT02991742|"~     Contrast media-induced nephropathy following diagnostic and therapeutic cardiac~     catheterization.~   "
43935|NCT02991729|"~     The investigators aim to assess whether use of a novel, tablet-based computerized decision~     aid for aneuploidy screening is similar to routine care with a brief genetic counseling visit~     in improving patient knowledge and decreasing decisional conflict.~   "
43936|NCT02991716|"~     Record cutaneous Electrocardiogram (ECG) data from positions corresponding to the expected~     subcutaneous locations of the Implantable Subcutaneous String Defibrillator (ISSD) using~     existing, approved ECG recording devices.~   "
43937|NCT02991703|"~     Arterial stiffness is an important marker of cardiovascular risk. It is measured by pulse~     wave velocity. The reference device to measure pulse wave velocity is the Sphygmocor which~     uses applanation tonometry. It is used in adults and children. An easier method called~     pOpmètre using saturation sensors is validated in adults but not in children. The objective~     of this study is to compare the pulse wave velocity values measured with the pOpmètre® with~     those of the SphygmoCor® to validate the pOpmètre in children between 4 and 8 years old.~   "
43938|NCT02991690|"~     This study is a prospective multi-center trial designed to determine the safety profile and~     efficacy of modest (33ºC) intravascular hypothermia following acute cervical (C1 to C8)~     Spinal Cord Injury (SCI).~   "
43939|NCT02991677|"~     Chemotherapy-induced peripheral neuropathy (CIPN) continues to be a serious healthcare~     concern. It is painful, persistent, resistant to conventional pain therapies, and results in~     long-term suffering and decreased quality of life for many cancer survivors. The role of~     exercise to decrease CIPN-related neuropathic pain (CIPN-NP) will be investigated, with the~     goal of identifying the mechanisms associated with this therapeutic approach to manage~     CIPN-NP.~   "
43940|NCT02991664|"~     The aim of this clinical trial was to compare the clinical performances of a glass ionomer~     restorative system with a micro hybrid resin based composite in extended sized class II~     cavities. A total of 100 class 2 lesions were restored with a glass ionomer restorative~     system (Equia Forte) or a micro hybrid composite (G-aenial Posterior). Restorations were~     evaluated at baseline and yearly during 6 years according to the modified-USPHS criteria.~     Data were analyzed with Cohcran's Q and McNemar's tests (p<0.05).~   "
43952|NCT02991508|"~     This is the first clinical trial with ADRECIZUMAB. The purpose of this clinical trial to~     identify safety and tolerability of different doses of ADRECIZUMAB in healthy volunteers.~   "
43972|NCT02991248|"~     This study is to test whether pelvis perturbation training paired with transcutaneous spinal~     direct current stimulation (tsDCS) will be effective in improving dynamic balance and~     locomotor function in humans with SCI. One group will receive pelvis perturbation training~     paired with tsDCS, one group will receive pelvis perturbation training paired with sham, and~     one group will receive treadmill training only.~   "
43941|NCT02991651|"~     Patient selection: a) Pathological confirmation of non-small cell lung cancer without~     activating EGFR mutations; b) Advanced stage disease (IV or IIIB with malignant effusion)~     with at least two prior chemotherapy regimens; c) No available curative therapy; d) Pregnant~     women are excluded; e) Informed consent.~      Pretreatment evaluation: a) Medical history and physical examination; b) Hepatic and renal~     function (bilirubin, aspartate aminotransaminase, creatinine); c) Preoperative staging~     evaluation including CT-chest or PET/CT scan;~      Treatment plan: Three dose levels of IRX4204 and erlotinib will be studied using~     intra-patient dose escalation for dose levels 1 and 2. These study agents will be~     administered orally until progression of disease, unacceptable toxicities, activation of a~     phase II study of the combination, or exhaustion of the IRX4204 drug supply.~      Evaluation on study: Adverse events will be graded on a scale of 0 to 5, using the Common~     Terminology Criteria for Adverse Events (CTCAE) v. 4.0. Efficacy will be assessed using the~     RECIST v1.1 criteria based on CT-chest or PET/CT scan after 8 weeks of study treatment.~   "
43942|NCT02991638|"~     Efficacy and Safety of ibrutinib in patients with chronic lymphocytic leukemia and other~     indolent B-cell lymphomas who are chronic hepatitis B virus carriers or occult hepatitis B~     virus carriers~   "
43943|NCT02991625|"~     Drugs used for managing chronic pain have not proven to be effective and chronic pain~     continues to cost Canadians $60 billion a year without truly helping those who suffer. The~     study proposes to investigate the factors related to a person that can enhance or reduce the~     effectiveness of pain treatments in people suffering with chronic pain. Treatment response to~     pain killers in a person may be related to their brain, genetics, social, and psychological~     makeup. The investigators aim to study these factors to identify and develop feasible and~     robust indicators based on a person's biological makeup (also called biomarkers). These~     biomarkers will allow doctors and researchers to predict more accurately which treatment and~     prevention strategies for a particular disease will work in which groups of people. These~     measures will offer new opportunities for improving treatment such as by tailoring treatment~     to meet the specific needs of each patient based on his/her biological and psychological~     makeup. Towards the specific aim, data will first be collected in several experimental~     domains for studying treatment expectations (cognitive, psychosocial, brain-related,~     genetic). These 'experimental' data will be compared between chronic back pain (CBP) and~     healthy participants to yield new understanding of the factors that govern treatment~     response. At the end of experimental data collection, the investigators will collect data in~     the 'clinical' domain. Hence, at the end of the experimental sessions, a subset of CBP~     participants will receive a mock drug (placebo disguised as an approved pain treatment) and~     another subset will provide pain ratings only and hence serve as a waiting list control for~     the placebo trial. Data will be studied in steps to understand factors that mediate treatment~     outcomes and finally the investigators will use advanced computational tools used for big~     data analysis and aim to identify factors that can be used as biomarkers and precision~     medicine tools.~   "
43944|NCT02991612|"~     The purpose of the study is to evaluate the safety and efficacy of Rifaximin in the treatment~     of cirrhotic gastroesophageal variceal bleeding.~   "
43945|NCT02991599|"~     This is a randomized, controlled trial. The study will evaluate the immunogenicity, immune~     persistence, and safety of 20 µg and 60 µg recombinant hepatitis B vaccine with three~     injections at months 0, 1, and 6 in methadone maintenance treatment patients.~   "
43946|NCT02991586|"~     Emotional instability disorder (IE) is appreciable since adolescence, and crises (suicidal~     ideation, self-harm, impulsive acts and brief psychotic episodes) carry a high use of health~     resources, coupled with the suffering of families who feel helpless and difficulties in~     handling.~      The purpose of the study is to evaluate the effectiveness of a dialectical behavior therapy~     (DBT) for parents of adolescents with IE who are in treatment in the different network~     devices of Child and Adolescent Mental Health of the Community of Madrid. Treatment goals are~     the development of communication skills, validation and crisis management as well as increase~     understanding and competence of the pathology.~      To evaluate the effectiveness of the DBT family group intervention, it is compared with a~     group of non-treatment or treatment as usual (outpatient treatment and parents without~     children specific group treatment). The DBT intervention will begin with two individual~     sessions with parents of patients and 10 theoretical and practical seminars in group format~     (6-7 families) following the model proposed by Marsha Linehan. The DBT interventions will be~     added to standard treatment that a patient with IE receives in the investigative devices.~      The result of these interventions will be measured after the end of treatment and after 6 and~     12 months after the treatment ends. The variables considered are family communication,~     cognitive skills, emotional and behavioral coping clinical in parents and as indirect~     measures of change in adolescents health resources used as , suicidal gestures, self-harm or~     aggressive behavior.~   "
43947|NCT02991573|"~     Damage to teeth from decay or previous old silver fillings can be repaired with~     tooth-coloured filling materials that stick to the tooth. These materials have been around~     for some years and have become more sophisticated; with greater ease of placement by the~     dentist and better durability for the patient. The fillings are designed to be used in~     combination with a specific glue (adhesive) that is designed to stick to the different parts~     of the tooth to provide a good seal, the outer enamel and the inner dentine.~      This study will examine the performance of a state-of-the-art modern tooth coloured filling~     material (Ceram X) in combination with an existing adhesive (control adhesive) and a new~     adhesive (Prime & Bond Universal) used in two different techniques; both of which are known~     to work but one is easier to apply. This results in three treatment groups.~      At the start of the study, the test material Prime&Bond Universal is CE-marked, as are all~     other medical devices used. Thus, this study is not conducted to meet any regulatory~     requirements. The rationale of this study is the extension of knowledge primarily concerning~     the clinical performance of Prime&Bond Universal in molars.~      Two investigators (to be confirmed) will place a minimum of 25 restorations per group (75~     restorations in total) to assess the performance of the materials in a comparative design.~     The study restorations will be monitored for a period of 18 months (with the option to extend~     the evaluation period to 48 months).~      After placement of restorations under controlled clinical conditions, the primary objective~     of the study is the determination of post-operative sensitivity and pulp vitality, marginal~     adaptation and staining of margins of the restorations. In addition, fracture of material and~     retention, recurrent caries, occlusal contour and wear, approximal anatomical form will be~     determined as well as the failure rate as defined by the ADA.~   "
43948|NCT02991560|"~     To compare the early effects of the application of elastic (Kinesio Tape®) and non-elastic~     (Athletic Tape) taping as part of the conventional physiotherapy of the lateral epicondylitis~     using the results from ultrasonography and clinical tests.~   "
43949|NCT02991547|"~     The purpose of this study is to find out more information about patients who have cancer~     (adenocarcinoma) of the esophagus or gastroesophageal junction (GEJ) who have been treated~     with chemotherapy and radiation but have not had surgery. The study will follow patients for~     5 years to monitor for their cancer and to see how the standard medical care affects the~     daily life of patients.~   "
43950|NCT02991534|"~     Background: Women Veterans are the fastest growing segment of Veterans Health Administration~     (VHA) users. This dramatic growth has created challenges for VHA. Gender disparities persist~     in cardiovascular (CV) and diabetes risk factor control, and rates of depression, anxiety,~     and mental health comorbidity are disproportionately high among women Veterans. Furthermore,~     a high rate of women Veterans' attrition from VA care, along with organizational barriers to~     care, substantiate that organizational changes are needed in order to engage and retain women~     Veteran VHA users in evidence-based, patient-centered care.~      Objectives: The Enhancing Mental and Physical health of Women through Engagement and~     Retention (EMPOWER) QUERI addresses VHA Blueprint for Excellence Strategy 6, by advancing~     personalized, proactive, patient-centered care models, and Transformational Strategy 7.2.g~     by implementation of innovative care models in women Veterans' health care. The EMPOWER~     QUERI Program is designed to improve women Veterans' engagement and retention in~     evidence-based care for three high priority health conditions, i.e., prediabetes,~     cardiovascular, and mental health. To achieve this impact goal, we propose a cohesive~     portfolio of projects with the following aims: (1) To use an evidence-based implementation~     strategy that emphasizes local tailoring of care models, multilevel stakeholder engagement,~     and systematic evaluation of complex implementation processes in order to enrich~     organizational capacity for innovations in women Veterans' VHA health care; (2) To implement~     personalized, proactive, patient-centered innovations in VHA women's health that are~     acceptable, feasible, satisfactory, relevant, and effective for both providers and patients,~     thereby encouraging women Veterans' engagement and retention and sustainability of the~     innovations; and, (3) To generate implementation playbooks for our partners that are~     scalable and serve as guidance for future implementation of a broader array of evidence-based~     women's health programs and policy.~      Methods: Three projects will be conducted by an experienced multidisciplinary team.~     Tailoring VA's Diabetes Prevention Program to Women Veterans' Needs is a one-year QI~     project to be conducted in VA Greater Los Angeles women's health clinics. Women Veterans with~     prediabetes will select an in-person, peer-led or online gender-specific, evidence-based~     diabetes prevention program to address their risk behaviors and health conditions.~     Facilitating Cardiovascular Risk Screening and Risk Reduction in Women Veterans will~     increase identification of CV risk among women Veterans, enhance patient/provider~     communication and shared decision-making about CV risk, and provide a supportive, coordinated~     health coaching intervention to facilitate women Veterans' engagement and retention in~     appropriate health services. Implementation of Tailored Collaborative Care for Women~     Veterans will evaluate implementation of an evidence-based collaborative care model tailored~     to enhance provider- and system-level capabilities to address women Veterans' anxiety and~     depression treatment needs, thereby improving organizational primary care-mental health~     integration (PC-MHI) effectiveness and women Veterans' engagement and retention in PC-MHI.~     Both implementation research studies will use a modified stepped wedge design and will apply~     the evidence-based Replicating Effective Programs (REP) implementation strategy. Mixed~     methods implementation evaluations will focus on investigating primary implementation~     outcomes of adoption, acceptability, feasibility, and reach. Multilevel stakeholder~     engagement will be prioritized. Program-wide organizational-, provider-, and patient-level~     measures and tools will be utilized to enhance synergy, productivity, and impact. As a~     coherent program of women's health implementation research and quality improvement, the~     proposed EMPOWER QUERI will constitute a major milestone in achieving BPE strategies and~     realizing women Veterans' engagement and, ultimately, empowerment in our VHA system.~   "
43951|NCT02991521|"~     This research study aims to improve the standard exam called Focused Assessment with~     Sonography in Trauma (FAST). The FAST exam is an ultrasound test used to identify an~     abdominal bleed. The study will see if having patients roll on their right side improves the~     FAST exam. Making the FAST exam better can help trauma doctors save the lives of patients~     with bleeding.~   "
43953|NCT02991495|"~     In July 2016, the demand for yellow fever vaccines in response to the large urban outbreaks~     occurring concurrently and the risk of further spread through the African continent and even~     to Asia, was larger than the available supply. In this situation, the World Health~     Organization (WHO) developed recommendations for the use of fractional-dose of yellow fever~     vaccine as a dose-sparing strategy. These recommendations were based on limited number of~     clinical trials and additional studies should assess the applicability of the fractional dose~     to all WHO-prequalified vaccines, the persistence of neutralizing antibodies and the~     performance of the fractional dose in young children and populations in Africa including~     those with HIV.~      This study aims to respond to some of the research questions that would allow broadening the~     recommendations on the use of fractional doses of yellow fever vaccine in emergency~     situations. The study will be conducted in Uganda and Kenya and the main objective is to~     assess the non-inferiority is seroconversion 28 days after vaccination of a fractional dose~     compared to full dose for each WHO-prequalified manufacturer. As secondary objectives the~     study will assess seroprotection 10 days and 1 year after vaccination, to assess rapidity and~     persistence of protective antibody levels; describe the geometric mean titre and the change~     in neutralizing antibody on Day 28 days after vaccination with fractional and full doses; and~     assess the occurrence of adverse events and serious adverse events (SAE) during 28 days after~     administration of fractional and full doses.~      The study consists of a randomized non-inferiority trial. The study aims to start in April~     2017 in the two sites and aims to recruit 960 adults. Results for the main outcome will be~     reviewed by the study Data and Safety Monitoring Board and one vaccine will be selected for~     the studies in children and HIV positive adults.~   "
43954|NCT02991482|"~     Trial comparing standard treatment (chemotherapy) with pembrolizumab treatment in patients~     with advanced pretreated malignant mesothelioma.~   "
43955|NCT02991469|"~     Primary Objective:~      To describe the pharmacokinetic (PK) profile of sarilumab in patients with sJIA in order to~     identify the dose and regimen for continued development in this population.~      Secondary Objective:~      To describe:~        -  The pharmacodynamic (PD) profile, the efficacy and the safety of sarilumab in patients~          with sJIA.~        -  The long term safety of sarilumab in patients with sJIA.~   "
43956|NCT02991456|"~     The purpose of this phase 2 study is to assess the efficacy and patient satisfaction of oral~     rolapitant plus ondansetron vs. oral ondansetron monotherapy in malignant glioma (MG)~     patients receiving standard of care radiation (RT) and temozolomide (TMZ) therapy. This is a~     randomized phase 2 trial of rolapitant plus ondansetron vs. ondansetron monotherapy for the~     prevention of chemo-radiation induced nausea and vomiting in primary MG subjects receiving RT~     and concomitant multi-dose TMZ.~   "
43957|NCT02991443|"~     Parents of children with chronic diseases often report increased level of stress and anxiety.~     The aim of the study is to assess the effect of mindfulness based stress reduction (MBSR)~     intervention on stress and anxiety of parents of children with inflammatory bowel diseases~     (IBD). The intervention is consisted of 8 group sessions managed by a certified psychologist.~     30 parents will participate. The efficacy of the intervention will be assessed by 3 validated~     questionnaires which will be filled by each participant prior to intervention, at the end of~     intervention and 3 months following interventions.~   "
43958|NCT02991430|"~     This study will assess the efficacy of a neuromodulation device for the treatment of episodic~     migraine headache.~   "
43959|NCT02991417|"~     This clinical study is conducted to assess the safety and immunogenicity of a Clostridium~     difficile vaccine (CDVAX) in healthy adult volunteers.~   "
43960|NCT02991404|"~     Patients undergoing Primary Total Knee Arthroplasty will be randomized to receive either~     multimodal single injection adductor canal block with sham infusion catheter or continuous~     infusion of local anesthetic (control) for postoperative analgesia.~      Primary end point is pain scores at 30 hours post performance of block procedure.~   "
43961|NCT02991391|"~     This cross-sectional survey study is intended to describe the characteristics of adults in 4~     US states with regards to respiratory symptoms and tobacco exposure, utilizing an existing~     state-administered, CDC overseen Behavioral Risk Factor Surveillance System telephone health~     survey. The primary goal of study is to describe the sociodemographics, health behaviors, and~     presence of chronic diseases in persons with or at risk of having chronic obstructive~     pulmonary disease.~   "
43962|NCT02991378|"~     This study is about early intervention for preschool children with emotional and stress~     related disorders. To develop a set of program that could be used in district hospitals for~     early intervention of preschool children with emotional and stress related disorder or~     problems.~   "
43963|NCT02991365|"~     Obesity if known to be associated with brain insulin resistance in humans. This condition has~     not only implication for the brain but also for whole-body energy homeostasis. Research in~     rodents indicates that weight loss is able to improve insulin sensitivity of the brain. The~     current project will test this hypothesis in humans. Therefore, brain insulin sensitivity~     will be assessed by fMRI in combination with intranasal insulin administration, using an~     established protocol. Furthermore, effects of daily administration of insulin nasal spray~     (versus placebo) over 8 weeks will be assessed as secondary (exploratory) variables.~   "
43964|NCT02991352|"~     Treatment of vascular malformations requires the placement of a needle within anatomically~     non well defined, pathological vessels, which may be as small as 1 mm, with the current state~     of the art relying exclusively on two dimensional fluoroscopy images for guidance. The~     investigators hypothesize that the combination of stereotactic image guidance with existing~     targeting methods will result in faster and more reproducible needle placements.~   "
43965|NCT02991339|"~     The investigators were aiming to evaluate whether dexamethasone administration accelerates~     the recovery from hepatectomy-related jaundice and decreases the rates of post-hepatectomy~     liver failure and its safety in the subjects who developed elevated serum total bilirubin.~   "
43966|NCT02991326|"~     This study aim to contribute with the investigation of the therapeutic effect of osteopathic~     manipulative treatment in pain intensity and Quality of Life in individuals diagnosed with~     temporomandibular disorder who make use of occlusal splints.~   "
43967|NCT02991313|"~     The purpose of this trial is to assess acute safety and performance of the Multi-electrode~     Linear Type Catheter in conjunction with generator software V2.4.0 or above when used for the~     treatment of Persistent Atrial Fibrillation.~   "
43968|NCT02991300|"~     The data registry will increase the knowledge of outcomes for treatment of focal cartilage~     defects of the patella treated with the BioPoly RS Patella Implant and will allow monitoring~     of the clinical safety and performance of the device and surgical implantation kit~   "
43969|NCT02991287|"~     To asses the precision of a score to predict chronic post surgical pain in patients~     undergoing inguinal hernia repair, abdominal hysterectomy, vaginal hysterectomy and~     thoracotomy. Prospective multicenter cohort study in 21 hospital in spain.~   "
43973|NCT02991235|"~     A 6-month randomized, double-blind and placebo-controlled, followed by a 6-month open label~     extension study.~   "
43975|NCT02991209|"~     The overall purpose of the study is to evaluate the effect of 12 months testosterone~     replacement therapy in testicular cancer survivors with mild Leydig Cell Insufficiency in~     order to reduce the risk of cardiovascular disease.~      The primary study objective is to evaluate changes in insulin sensitivity. The secondary~     study objective is to evaluate changes in the prevalence of metabolic syndrome, body~     composition, systemic inflammation and symptoms of testosterone deficiency.~   "
43976|NCT02991196|"~     This trial is being performed in two parts: Dose Escalation and Dose Expansion.~      The primary objective for the Dose Escalation part is to determine the safety and~     tolerability at different doses of DS-8273a administered in combination with nivolumab and to~     identify the dose combination for the Dose Expansion cohort in subjects with mismatch repair~     (MMR)-proficient advanced colorectal cancer.~      The primary objectives for the Dose Expansion part are:~        -  To further evaluate the safety and tolerability of DS-8273a administered at the selected~          dose in combination with nivolumab in subjects with MMR-proficient advanced colorectal~          cancer~        -  To evaluate preliminary anti-tumor activity of DS-8273a plus nivolumab administered at~          the selected dose in subjects with MMR-proficient advanced colorectal cancer~   "
43977|NCT02991183|"~     Background: Acceptance and Commitment Therapy (ACT) is a therapy that helps people to notice~     and accept difficult thoughts and emotions. ACT also helps people to identify what they value~     in life (e.g. a good relationship with their partner) and make changes to their behaviour to~     promote these values. Carers of people with dementia may experience reduced wellbeing~     associated with their role. Those whose wellbeing is greater than previously are said to be~     'flourishing'.~      Aim: The aim of this feasibility study is to evaluate the potential value of ACT as a group~     intervention for carers of people with dementia.~      Methods: Participants will include adult carers of people with dementia. Study participants~     will be identified from two older people community mental health teams. Informed consent will~     be sought prior to group invitations being sent out. There will be two groups in total (12 in~     each group) and both groups will attend three 2.5 hour sessions of ACT. All participants will~     complete questionnaires at the beginning and 21 days later (asking questions about their~     thoughts and feelings, flourishing and about being a carer). Eight group participants will be~     invited to a focus group to understand what they found more helpful and less helpful.~      Applications: Results from this study will potentially provide useful information to enable a~     further study with more participants to be conducted. The outcomes of this study will be~     shared with older people community mental health teams, dementia and carer specialist groups~     and potentially published in a relevant journal.~   "
43978|NCT02991170|"~     Patients with myocardial infarction related potential malignant ventricular arrhythmia have~     high risk of sudden death. The aim of this clinical trial is evaluating therapeutic efficacy~     of unipolar or bipolar radiofrequency ablation in Coronary Artery Bypass Grafts (CABG)~     Surgery, which can reduce myocardial ischemia and block reentry circuits of ventricular~     arrhythmia at the same time. The observation indexes include the morbidity of potential~     malignant ventricular arrhythmia and major adverse cardiovascular events in mid-long-term~     after CABG surgery.~   "
43979|NCT02991157|"~     This prospective observational study will assess the regional cerebral oxygen saturation and~     cardiac output non-invasively in patients with subarachnoid hemorrhage during nimodipine~     administration for the prevention/management of cerebral vasospasm.~   "
43980|NCT02991144|"~     A Phase 1/2, open-label dose-finding safety study of single ascending doses of DTX301 in~     adults with late-onset OTC Deficiency~   "
43981|NCT02991131|"~     This open-label, prospective, multi-center, non-interventional, observational, parallel~     cohort study intends to provide real life data on the treatment duration, effectiveness and~     safety of tedizolid and linezolid when treating ABSSSI hospitalized patients in a real~     practice setting.~   "
43982|NCT02991118|"~     The purpose of this study is to see if bemedoic acid (ETC-1002) is effective versus placebo~     in patients with high cardiovascular risk and elevated LDL cholesterol not adequately~     controlled by their current therapy.~   "
43983|NCT02991105|"~     Cancer remains a major cause of morbidity and mortality post solid organ transplantation.~     While mortality from the other leading causes of death post-transplantation (e.g.~     cardiovascular disease and infection) is declining, mortality from cancer~     post-transplantation is increasing. This is due to both general and transplant-specific risk~     factors that combine to increase risk for cancer compared to the general population. However,~     there is a shortage of research exploring cancer epidemiology post solid organ~     transplantation in the UK. This is essential to guide clinicians and for counselling patients~     regarding expectations and outcomes after developing cancer post-transplantation. This is~     especially important as the aetiology, pathophysiology and outcomes of cancer~     post-transplantation may differ from the general population.~      Available data registries in the UK separately contain valuable cancer and~     transplant-specific data that can be combined to explore cancer epidemiology~     post-transplantation more comprehensively, which can be directly translated into patient~     benefit by utilizing transplant-specific data (rather than translating from general~     population or non-UK patient demographics).~      The purpose of this project is to combine existing data resources to link up the complete~     patient journey for solid organ transplant recipients nationally and focus on the entire~     spectrum of cancer from incidence to mortality. In addition, recruitment of local solid organ~     transplant recipients will facilitate a more enriched analysis of raw-level data for~     investigation of screening and management for cancer among solid organ transplant recipients.~   "
43984|NCT02991092|"~     To compare the influence of two different fluid administration strategies on the clinical~     efficacy of patients with colorectal carcinoma during the fast-track surgery.~   "
43985|NCT02991079|"~     This is a randomized, clinical trial aimed at diabetics between 25-70 years (with no~     cardiovascular disease) selected at urban primary care health clinics in Salamanca (Spain).~     It is aimed at assessing the effects of adding an ICT (information and communication~     technology) tool, developed for the Smartphone application and group activities of healthy~     food and cardio-health rides in support of behavioral and educational recommendations in the~     increased physical activity and adaption to the Mediterranean dietary pattern.~   "
47553|NCT02944474|"~     The objectives of this study were to evaluate the safety and tolerability of lucerastat and~     to determine its pharmacokinetic profile after multiple dosing. Also, the potential effect of~     food on the pharmacokinetics of lucerastat was explored following a single dose of 500 mg.~   "
43986|NCT02991066|"~     Although the clinical application of differentiation therapy has made great success in the~     treatment of acute promyelocytic leukemia (APL), early fatal bleeding remains an unsolved~     problem which accounts for the main reason of induction failure in APL patients. The clinical~     manifestation of both serious bleeding and thrombosis illustrate the complexity of the~     pathogenesis of coagulopathy in APL. Despite extensive research, the pathogenesis of~     coagulopathy in APL is still unclear. Microparticles, 0.11μm in diameter, are small membrane~     vesicles released to circulation by blood cells and vascular endothelial cells during~     activation or apoptosis. Microparticles (MPs) derived from different cells types all exert~     procoagulant activity mediated by phosphatidylserine (PS) and carry some basic substances~     derived from their origin cells. Also, the biological activity of microparticles is often~     significantly higher than that of the cells they come from. According to these problems and~     background knowledge, our project aims to observe the roles of microparticles derived from~     APL cells and the procoagulant or profibrinolytic activating factors resided on these~     microparticles in the pathogenesis of coagulopathy in APL, and the effects of different~     induction therapies, chemotherapeutic drugs or differentiation agents on these microparticles~     and their procoagulant or profibrinolytic activating factors. To carry out this study,~     microparticles are obtained from patients who undergo different induction therapies at~     different time points or from primary bone marrow APL cells which are treated by different~     drugs in vitro at different time points, the expressions and activities of five procoagulant~     or profibrinolytic activating factors, which are highly expressed in APL cells, PS exposure~     and the functional state of these microparticles, will be dynamically monitored. Further~     study of the pathogenesis of coagulopathy in APL can provide clues and help for deep~     understanding of clinical manifestations, guiding clinical treatment as well as judging~     prognosis, and establishing theoretical basis for exploring new treatment.~   "
43987|NCT02991053|"~     the aim of this study is to compare the effects of Transversus abdominis plane block and~     ilioinguinal / iliohypogastric block combined with sedation in pediatric surgeon on the~     anesthesia and analgesia contributions during surgery without general anesthesia.~   "
43988|NCT02991027|"~     To evaluate the image qualities and segmentation performance of Topcon's DRI OCT Triton~     devices using two light sources.~   "
43989|NCT02991014|"~     This study aims to compare the impact of listening to frequency-modulated music vs.~     non-modulated music (both researcher-selected), and to test whether there are differential~     effects on pain and stress perception. Further, these two conditions will be compared to a~     third condition, in which participants will be exposed to self-selected non-modulated music.~     It is hypothesized that both researcher-selected frequency-modulated music and self-selected~     non-modulated music result in stronger decreases in stress and pain compared to~     researcher-selected non-modulated music, while it is expected that there will be no~     differences in researcher-selected frequency-modulated music and self-selected non-modulated~     music. The intervention consists of ten sessions of music listening in the course of three~     consecutive weeks.~   "
43990|NCT02991001|"~     Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with~     involving compression of the median nerve in the carpal tunnel. Rather than other progressive~     disease, CTS is characterized by remission and recurrence. The hydrodissection could decrease~     the entrapment of nerve to restore blood supply. Despite the hydrodissection was pervasively~     used in clinical practice, current researches contain small participant without control group~     or randomized leading to foreseeable selection bias. The investigators design a randomized,~     double-blind, controlled trail to assess the effect after ultrasound-guided hydrodissection~     in patients with CTS.~   "
43991|NCT02990988|"~     The goal of this pilot study is to test whether the microbiome is affected by intravenous~     iron repletion.~   "
43992|NCT02990975|"~     Aim of this study; Intra-operative anesthesia and analgesia effects of Transversus Abdominis~     Plane Block supported by ketamine sedation only.~   "
43993|NCT02990962|"~     Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with~     involving compression of the median nerve in the carpal tunnel. Rather than other progressive~     disease, CTS is characterized by remission and recurrence. Although many conservative~     managements of CTS, the effectiveness of these methods is insignificant or only persist for a~     short duration including steroid injection. Recently, the ultrasound-guided perineural~     injection with 5% dextrose was widely used for entrapment neuropathy with positive benefit.~     The investigators design a randomized, double-blind, controlled trail to assess the effect of~     ultrasound-guided perineural injection with 5% dextrose in patients with CTS and compared~     with steroid injection.~   "
43994|NCT02990949|"~     The aim of this study is to examine the length of ovarian stimulation with the timing of~     trigger in an IVF cycle and its potential to impact patient outcomes.~   "
43995|NCT02990936|"~     The purpose of this study is to determine the impact of tumor growth velocity on the survival~     of patients with oropharyngeal squamous cell carcinoma treated by (chemo-)radiotherapy.~      Patients with stages I to IV oropharyngeal primary squamous cell carcinoma (OPSCC) elected~     for radiotherapy or radiochemotherapy with curative intent will be selected. Tumor volume and~     number and size of pathological neck lymph nodes (small diameter > 1 cm) will be assessed on~     diagnostic CT-scan (DiCT) and treatment planning CT-scan (RtCT) using the summation of areas~     technique. Tumor progression and tumor doubling time will be calculated based on DiCT and~     RtCT. Tumor proliferation will be assessed on biopsy specimens by Ki67 immunohistochemistry~     and mitotic index. HPV status will be evaluated by PCR and p16 immunohistochemistry.~     Ulcerative or exophytic aspect will be noticed. Tumoral kinetics patterns will be correlated~     with disease free survival and overall survival of patients with OPSCC. These patterns will~     be compared to HPV status and proliferation markers in order to study their clinical~     signification [time frame: 5 years] and develop predictive markers of tumor progression for~     head and neck cancers.~   "
43996|NCT02990923|"~     The purpose of this study is to investigate whether the usage of High-Flow Needleless Valve~     and DualCap Disinfection Devices would reduce the incidence of catheter-related bloodstream~     infection in hemodialysis patients.~   "
43997|NCT02990910|"~     A high incidence of respiratory morbidity after adenotonsillectomy is reported in children~     with obstructive sleep apnea syndrome (OSAS). So we designed a prospective, double-blind,~     randomized controlled study to determine the effects of individualized opioid analgesia~     compared with conventional opioid analgesia on respiratory morbidity after adenotonsillectomy~     in Children with OSAS.~   "
43998|NCT02990897|"~     Researchers now know that treating chronic kidney disease (CKD) in its early stages can~     prevent dialysis and reduce heart problems that go along with kidney disease. Computerized~     tools may help primary care doctors to diagnose the disease earlier and computer reminders~     may help doctors to prescribe the best treatments. In this project the investigators will~     test computer reminders in primary care clinics to see if they improve treatment of early~     chronic kidney disease and to see if it can promote referral to nephrology.~   "
47554|NCT02944461|"~     To determine if Dapsone (Aczone) 7.5% gel is a safe and effective treatment for acne on the~     trunk~   "
44000|NCT02990871|"~     All the patients hospitalized in the neuro-rehabilitation after a severe acquired brain~     injury carrying a tracheal cannula will be retrospectively analyzed. Patients coming from~     emergency department started a rehabilitative treatment during their hospitalization in ICU.~     Patients transferred from an external ICU started the rehabilitation in neurorehabilitation~     department. Aim of the study is to evaluate if an early rehabilitation, started since the~     acute stage of the damage, is able to reduce the decannulation time in this group of~     patients.~   "
44001|NCT02990858|"~     This is an extension study, to provide continued access to PRO 140 to subjects who complete~     participation in PRO140_CD02 and continue to receive clinical benefit and would require PRO~     140 to form a viable regimen, in the opinion of the treating physician. The patient~     population for this trial are treatment-experienced HIV infected patients with CCR5-tropic~     virus who demonstrate evidence of HIV-1 suppression after successfully completed 24 weeks of~     treatment in the PRO140_CD02 study.~   "
44002|NCT02990845|"~     This is an open-label, single-arm, multicenter, pilot study of pembrolizumab, exemestane, and~     leuprolide for subjects being resistant for front-line hormonal therapy for inoperable~     locally advanced or metastatic hormonal receptor positive (HR+)/ Human epidermal growth~     factor receptor 2 (HER2) negative breast cancer. All the patients will be included in the~     final tolerability and preliminary efficacy analysis. The efficacy objectives including PFS,~     overall response rate (ORR), clinical benefit rate (CBR), and duration of response (DOR).~     Adverse effects will be recorded according to CTCAE v4.0.~   "
44003|NCT02990832|"~     In 2011, the premiers of all Canadian provinces and territories selected diabetes foot care~     as 1 of 3 significant targets for pan-provincial action. Of 210,000 people with diabetes in~     Alberta, 5,250 will seek treatment of a foot ulcer annually. In Alberta in 2014-15 there were~     425 lower limb amputations (LLA). Moreover, there is a tremendous reduction in quality of~     life of the patients and attendant negative effects on their families. The 5-year mortality~     rate after new-onset diabetic foot ulcer is 43-55% and as high as 74% for patients undergoing~     LLA (CIHI, 2013). The Diabetes Foot Care Clinical Pathway Project (DFCCPP) aims to optimize~     methods of early detection and treatment of foot ulcers in an effort to reduce LLA by 50% by~     implementing High Risk Foot Teams (HRFTs) across the province starting with 3 Pilot sites.~     Existing staff with expertise and knowledge in diabetic foot care will assess and treat~     patients with moderate and high-risk findings.~      In conjunction with the DFCCPP, the efficacy of a technological advancement developed by an~     Alberta-based small-to-medium enterprise (SME) to improve diabetic foot outcomes will be~     evaluated. Exsalt® SD7 Wound Dressings (Exciton Technologies, Edmonton, AB) have been~     demonstrated in-vitro and in-vivo to provide rapid and effective antibacterial activity in an~     easy-to-use format, thus creating an enhanced wound healing environment while supporting~     patient quality of life.~      The objective of the proposed work is twofold, namely 1) to quantify clinical efficacy of~     exsalt® Wound Dressings on locally infected diabetic foot ulcers not progressing to healing~     under the current standard of care: evaluating key indicators of infection, Infectious~     Diseases Society of America (IDSA) wound classification, and wound size; identifying benefits~     to foot ulcer healing and 2) to evaluate subjective patient outcomes: satisfaction, perceived~     benefit, compliance. Evaluating the benefits of utilization of the Exciton exsalt® Wound~     Dressings when combined with the DFCCP.~   "
44004|NCT02990819|"~     This is a Phase II trial to determine the ability of a reduced intensity conditioning regimen~     to allow successful engraftment with alpha/beta T and CD19+ depleted peripheral stem cell~     grafts from unrelated or partially matched related donors. There are two conditioning~     regimens depending upon patient diagnosis and age.~   "
44005|NCT02990806|"~     The purpose of this study is to demonstrate similarity of NI-071 (proposed biosimilar to~     infliximab) to US REMICADE® (reference product) in terms of safety and efficacy in patients~     with rheumatoid arthritis (RA) not adequately responding to methotrexate (MTX).~   "
44006|NCT02990793|"~     The purpose of this study is to evaluate the safety and efficacy of individualized,~     Biometrics-guided Magnetic e-Resonance Therapy (MeRT) treatment of Persistent Post-Concussive~     Symptoms (PPCS) following Traumatic Brain Injury (TBI).~   "
44007|NCT02990780|"~     This protocol is a phase III randomized controlled trial (RCT) evaluating the efficacy of~     induction chemotherapy followed by accelerated hypofractionated vs. conventionally~     fractionated concurrent chemo-radiotherapy for limited-stage small cell lung cancer.~   "
44008|NCT02990767|"~     The aims of this study are to develop algorithms based on a combination of maternal factors,~     uterine artery PI, MAP and serum biomarkers to estimate patient-specific risks for early~     Preeclampsia (PE) and to evaluate the screening performance of such algorithms in twins.~   "
44009|NCT02990754|"~     Fearless Physical Activity are fun, physical literacy events where people with congenital~     heart disease (CHD) and sport/recreation leaders can do community-based sport/recreation~     opportunities without fear (i.e., appropriate for their health). Ontarians with CHD are a~     large and rapidly growing population;1% of children are born with CHD, adding 1,440 new~     children/year to the 113,900 Ontarians of all ages who are living with CHD. 'Fearless' will~     target CHD children, youth or adults, while encouraging family-based participation. During~     each season, the investigators will offer a one-day event for each age group (children,~     youth, adults) in each region of Ontario (4 seasons x 3 age groups x 4 regions = 48 events).~     Event activities will be hosted by community partners, such as the MLSE Launch Pad (Toronto)~     or the YMCA/YWCA of the National Capital Region (Ottawa), so that they are sustainable beyond~     this project. Activities will be chosen based on opportunities available in local communities~     at little to no cost (e.g., use of local trails and parks). Event leaders and participants~     will be educated about physical literacy and screening tasks will be used to identify those~     needing significant or specialized physical literacy support. People with CHD lead mostly~     sedentary lives. They are much less active than their friends and colleagues, even when their~     heart disease is mild, and inactivity can contribute to a higher risk for heart attacks,~     stroke, obesity, and depression. Uncertainty about physical activity, even though it is~     recommended (American Heart Association, May 2014), is an important barrier to the physical~     and mental health benefits of physical activity. How much is too much? and Will it be too~     much for my heart? are top-of-mind. Fearless Physical Activity will provide children,~     youth and adults living with CHD with new physical activity experiences and opportunities to~     enhance their physical literacy so they are better able to be active for life.~   "
44023|NCT02990572|"~     The purpose of this registry is to find members of the Plain Community who are interested in~     participating in future medical research studies. Having a registry makes it easier to~     contact and offer study participation to individuals who are appropriate for a new research~     study based on their own and their family medical history. Studies will focus on increasing~     knowledge about disorders affecting those who are Amish and Mennonite.~   "
44024|NCT02990559|"~     This pilot study is designed to investigate (1) whether getting iron treatment affects iron~     in the brain and (2) how getting iron treatment affects brain functions when it is performing~     specific cognitive tasks. By cognitive tasks, it means tasks that involve perceiving,~     representing, or assessing things. The specific cognitive tasks used here will involve tests~     of memory and processing speed.~   "
44025|NCT02990546|"~     The aim of this study is to investigate the role of oral midodrine in the recovery of septic~     shock. The investigators hypothesize that the oral drug can reduce central line days and ICU~     length of stay.~   "
44010|NCT02990741|"~     1. Study name:A randomized clinical trial on atrial fibrillation screening by using an~          automated electrocardiogram system in an elderly Chinese population~        2. Rationale: Failure in the diagnosis and management of atrial fibrillation leads to high~          incidence of stroke and high mortality and disability. It is therefore imperative to~          diagnose and manage atrial fibrillation in a timely and effective fashion to prevent the~          complications of atrial fibrillation.~        3. Objective:The primary objective is to investigate whether more frequent ECG recordings~          and analyses with this automated ECG system (4 times/year) would significantly improve~          the detection of atrial fibrillation compared to a single annual ECG screen.The~          secondary objective is to explore whether even more frequent ECG recordings and analyses~          (8 times/year) would further improve the detection of atrial fibrillation.~        4. Study design: The present study is designed as a randomized controlled trial of parallel~          group (two).~        5. Study population: Men and women aged at least 65 years (n=7000) meet the~          inclusion/exclusion criteria.~        6. Randomization and treatment: Eligible subjects will be randomized in a 1:1 ratio into~          the usual and intensive screening groups with 3500 patients in each group, and within~          the intensive screening group in a 3:1 ratio into the intensive and more intensive~          subgroups with 2625 and 875 patients, respectively.~        7. Follow up: 1)Usual screening group: ECG recordings at baseline plus at 1 year of~          follow-up; two ECG recordings in total. 2)Intensive screening subgroup: ECG recordings~          at baseline plus quarterly during follow-up, at months 3, 6, 9 and 12; 5 ECG recordings~          in total. 3)More intensive screening subgroup: ECG recordings at baseline plus weekly~          during the first month of follow-up and quarterly afterwards, at weeks 1, 2, 3 and 4 and~          months 3, 6, 9 and 12; 9 ECG recordings in total.~        8. Sample size estimation: The number of required subject for the whole trial is 7000.~        9. Timeline: Start of subjects enrollment : December 2016; End of subjects enrollment :~          June 2017; End of study : June 2018~       10. Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin~          Hospital, Shanghai, China.~   "
44011|NCT02990728|"~     Primary objective To discover the efficacies of levonorgestrel-containing intrauterine device~     (LNG-IUS, Mirena®), with or without metformin, as fertility-preserving treatment for grade 1~     endometrioid adenocarcinoma of endometrium, cT1aN0M0 with presumed no myometrial invasion on~     image study (MRI preferred).~      Secondary objectives~        1. To discover the morphological and molecular change in the endometrium tumor before and~          after treatment~        2. To discover the effectiveness of adding oral progestin to subjects who show no good~          response to assigned~        3. To compare (1) the systemic effects, including body weight change, neuropsychiatric~          alternation, GI disturbance, skin disorder, change in serum metabolic and hepatic~          markers between the two study patient groups; (2) The rate of long-term success defined~          as (a) sustained remission of >= 12 months starts from the histologic documentation of~          complete remission (b) rate of pregnancy and (c) alive baby delivery, based on~          time-to-event analysis.~        4. Molecular markers and their expression before, during and after treatment, including~          progesterone B receptor, progesterone A receptor, estrogen receptor, Ki67, PTEN and its~          related markers, Bcl2 and its related markers and other developing markers. This is to~          discover prediction markers to medical treatment.~   "
44012|NCT02990715|"~     The purpose of this study is to establish the efficacy of Check-Cap's C-Scan System in~     providing structural information on colonic polypoid lesions and masses, as an adjacent tool~     to FIT.~   "
44013|NCT02990702|"~     The retroclavicular approach for brachial plexus anesthesia requires an optimal angle between~     the needle and the ultrasound beam. Retroclavicular approach has already been proven~     effective and safe in the past. The general objective is to provide a formal comparison~     between the retroclavicular approach and coracoid infraclavicular approach for brachial~     plexus anaesthesia. This study should represent the differences between the two techniques.~   "
44014|NCT02990689|"~     The purpose of this study is to compare the performances of 2 bifocal IOLs and 1 trifocal IOL~     for far, near and intermediate vision.~   "
44015|NCT02990676|"~     Cognitive impairments, especially deficits of executive function, have been well documented~     as a core and early feature in Huntington's disease (HD). Cognitive impairments can be~     considerably burdensome and devastating for people and families affected by HD. Computerised~     cognitive training interventions that focus on improving executive function present a~     potentially exciting non-pharmacological treatment option. Novel work conducted in mouse~     models of HD, has demonstrated that cognitive training, administered from an early stage in~     the disease, can improve motor performance at an older age, even in the absence of further~     training in the intervening time. This represents proof of principle in an animal model of HD~     that cognitive training can improve HD disease symptoms.~      Improvements associated with executive function training have also been reported in a~     clinical setting in a variety of neurodegenerative diseases. For example, cognitive training,~     can improve executive function as people age, and training specifically focused on tasks of~     executive function has been shown to improve both cognitive and motor outcomes in~     neurodegenerative diseases such as Parkinson's disease (PD) and Alzheimer's disease (AD).~     Therefore, this study is a feasibility study which aims to establish proof of principle for~     using computerised cognitive training in people with HD. The investigators propose to~     determine the feasibility, acceptability and gather preliminary evidence of the effectiveness~     of a cognitive training intervention programme, targeted for people with HD. The~     investigators will also aim to investigate the most appropriate outcome measures to use in~     this study and gather feedback on the cognitive training intervention. The investigators will~     also establish proof of concept via the study of brain structure and function, using MRI~     scanning techniques.~      The computerised cognitive training software and the associated outcome measures will be~     investigated, taking into account the views of people and families who are affected by HD. A~     randomised feasibility study of computerised cognitive training for people with HD will then~     be conducted. Participants who are randomised to the cognitive training intervention group~     will be asked to complete a cognitive training intervention utilising HAPPYneuron software.~     Participants in the intervention group will be asked to complete the cognitive training~     programme for a minimum of 30 minutes, 3 times a week for the 12 week study duration.~     Participants in the control group will not receive any cognitive training and will be asked~     to continue as normal, however they will have home visits to control for the confounding~     effect of social interaction. Additional monitoring and prompting for the intervention group,~     will be conducted via email, text or telephone reminders (as preferred by the participant)~     and home visits. The motor and cognitive function of participants will be assessed at the~     beginning and end of the study, using a range of motor and cognitive assessments. Additional~     cognitive measurements will be recorded as part of the HAPPYneuron programme throughout the~     cognitive training intervention, such as accuracy and response time measures of particular~     computer games. MRI scans (optional) will be conducted at the beginning and end of the study~     to identify any structural changes in the brain that may be associated with the cognitive~     training intervention. As part of the feasibility and acceptability assessment, participants,~     family members and carers will be invited to complete a semi-structured interview at the end~     of the study, if consent is obtained, focusing on using this type of software as a home based~     therapeutic intervention.~   "
44016|NCT02990663|"~     High blood pressure is common and its presence increases the risk of cardiovascular mortality~     and morbidity (most notably stroke, myocardial infarction, and congestive heart failure).~     Given blood pressure is normally higher during the day than it is overnight, blood pressure~     lowering medications are traditionally taken in the morning. However a randomized trial of~     2156 Spanish hypertension patients published in 2010 (MAPEC), suggests a large (61%)~     reduction in mortality and cardiovascular morbidity if such medications are instead taken at~     bedtime. This degree of benefit far exceeds other established methods of cardiovascular risk~     reduction - and such a surprisingly large effect requires independent confirmation for~     practice to change. BedMed is a pragmatic randomized controlled trial (target N = 8750)~     facilitated by over 300 Canadian family physician members of the Pragmatic Trials~     Collaborative. During the conduct of this trial consenting hypertensive primary care~     patients, already established on one or more antihypertensive medications, will be randomized~     to either morning or bedtime antihypertensive use. Patient oriented trial outcomes evaluating~     both potential benefits and harms will be drawn largely from administrative health data that~     is routinely collected on all residents of Canada's publicly funded health care system. This~     trial is event driven (ending upon the occurrence of 406 primary outcome events) and expected~     to run over a period of roughly 3 years.~   "
44017|NCT02990650|"~     Using a randomized controlled research design, compare walking outcomes resulting from gait~     and balance training with standard physical therapist interaction versus training with the~     addition of a KineAssist® robotic system that provides for safety and freedom of movement.~   "
44018|NCT02990637|"~     The purpose of this study is to investigate the effects of daily supplementation of OLECOL~     for a period of 8 weeks on cardiovascular risk markers.~   "
44019|NCT02990624|"~     Ultraviolet (UV) phototherapy is a standard treatment for many inflammatory dermatological~     diseases, including psoriasis. The systemic effects of UV phototherapy are still not well~     studied. There are several factors that may affect patient's cardiovascular (CV) risk during~     UV phototherapy. Atherosclerosis is now known to have an inflammatory origin and to be~     frequently associated with psoriasis. In this study the investigators aim at studying the~     effect of psoralen-UVA phototherapy on several biomarkers of CV risk in patients with~     psoriasis with or without atherosclerosis.~   "
44020|NCT02990611|"~     Real-Life Efficacy and Safety of Nivolumab monotherapy or in combination with Ipilimumab in~     Patients with Advanced (Unresectable or Metastatic) Melanoma~   "
44021|NCT02990598|"~     To examine the pharmacokinetics and distribution of oral hydroxyurea when administered as a~     single dose to lactating women~   "
44022|NCT02990585|"~     This study will be a comparative design between 2 groups of subjects attending classes on~     back education in an urban setting. Participants will be randomized to either an individual~     one-on-one back school session or to the 8 group sessions.~   "
44026|NCT02990533|"~     The goal of this study is to collect preliminary data on the efficacy of interventions to~     enhance recovery from hospitalization in community dwelling older adults.~   "
44027|NCT02990520|"~     The purpose of this study is to determine the prevalence of malnutrition and/or sarcopenia at~     admission to the hospital in older adults.~   "
44028|NCT02990507|"~     An Advanced Virtual Exercise Environment Device (AVEED) has been developed that incorporates~     arm and leg ergometers in conjunction with a virtual reality interface. The purpose of this~     study is to examine participant perspectives regarding the virtual interface and exercise~     device combination with regard to usability, comfort, safety, rating of perceived exertion,~     and enjoyment.~   "
44029|NCT02990494|"~     Making healthy food choices requires sacrificing immediate pleasures of consuming high~     calorie foods in order to achieve long-term health goals. Two strategies to encourage such~     future thinking are 1) focusing on the long-term consequences of consuming unhealthy foods,~     and 2) focusing on the long-term benefits of avoiding these unhealthy foods. Two novel~     behavioral weight loss (BWL) interventions will be developed based on these strategies~     (PREVENT and PROMOTE) and compared to standard Internet-delivered BWL to test their~     feasibility and efficacy in changing food choice decision-making, reducing food cravings, and~     ultimate weight loss.~   "
44030|NCT02990481|"~     1. To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLTs) of~          TRK-950 as single agent~        2. To establish the dose of TRK-950 recommended for future phase 2 studies~   "
44031|NCT02990468|"~     This is a Phase 1a-b study of newly diagnosed patients with biopsy-proven head and neck~     cancer (squamous cell carcinoma) who are undergoing standard radiation therapy and treatment~     with cisplatin. BMX-001 added to radiation therapy and cisplatin is expected to reduce~     radiation-induced mucositis and xerostomia and also has the potential to benefit the survival~     of head and neck cancer patients. In Phase 1a, safety and tolerability of BMX-001 will be~     assessed using a Continual Reassessment Method (CRM) and a maximum tolerated dose (MTD) will~     be determined. BMX-001 will be given subcutaneously first with a loading dose zero to four~     days prior to the start of chemoradiation and followed by twice a week doses at one-half of~     the loading dose for the duration of radiation therapy plus two weeks. In Phase 1b both~     safety and efficacy of BMX-001 will be evaluated. Impact on mucositis and xerostomia will~     also be assessed. A maximum of 48 patients will be enrolled to the MTD dose determined in~     Phase 1a to confirm the MTD. The investigators hypothesize that BMX-001 when added to~     standard radiation therapy and cisplatin will be safe at pharmacologically relevant doses in~     patients with newly diagnosed head and neck cancer. The investigators also hypothesize that~     in Phase 1b of this study the addition of BMX-001 will reduce the severity of~     radiation-induced mucositis and xerostomia in patients receiving head and neck radiation~     therapy.~   "
44032|NCT02990455|"~     The proposed research will investigate whether smokers with vs. without current at-risk~     alcohol drinking (ARD) respond to reduced nicotine cigarettes by increasing their alcohol~     consumption or smoke exposure, thereby diminishing the hypothesized public health benefit of~     these new products.~   "
44033|NCT02990442|"~     Forensic patients will undergo 30 rTMS treatments, once per day each business day using a 1Hz~     frequency at the right dorso-lateral pre frontal cortex, located using modified BEAM F3.~     Patients will be assessed before and after the study with a battery of assessments and using~     2 computer tasks: a ball passing task, and the Point Subtraction Aggression Paradigm (PSAP).~     The investigators will also monitor and record aggressive incidents that take place on the~     unit.~   "
44034|NCT02990429|"~     Perioperative hypothermia is a common problem. It has been defined as a core temperature~     below 36ºC. The reasons why patient undergoing gynecologic laparoscopic surgery has~     perioperative hypothermia because the reduced metabolic heat production, redistribution of~     heat from the core to the periphery and impaired thermoregulation (due to anesthetics), use~     of cool carbon dioxide gas insufflations and surgical irrigation solution, as well as heat~     loss due to the cool environment. This perioperative problem has been linked to adverse~     patient outcomes such as myocardial ischemia as hypothermia increases plasma catecholamine,~     surgical site infection as hypothermia diminishes wound tissue O2 tension and coagulopathy as~     hypothermia impairs platelet function.~      It claims that perioperative heat loss occurs by radiation (60%), convection (25%) and~     evaporation (10%). This is caused by the difference between peripheral body and ambient~     temperature, air circulation around the body and vasodilatation.~      In daily practice, most anesthesia personnel warm patient peri-operatively by using force air~     warmer and intravenous fluid warmer.~      This study aimed to compare the difference of core and room temperature in patients~     undergoing gynecologic laparoscopic surgery by using forced air and intravenous fluid warmer~   "
44035|NCT02990416|"~     This study evaluates the effectiveness of adding a single four-day treatment of the fusion~     protein A-dmDT390-bisFv(UCHT1) — plus single palliative tumor radiation — with standard of~     care KEYTRUDA (Pembrolizumab) therapy for the treatment of metastatic melanoma. The results~     will be measured by comparing the combined therapy to historical data of KEYTRUDA alone.~   "
44036|NCT02990403|"~     In this clinical cohort study, the investigators are going to observe the efficacy of~     anti-coagulation and immune therapy in the treatment of recurrent pregnancy loss with a~     prospective randomized controlled trial.~   "
44037|NCT02990390|"~     RSA is a multifactorial disorder resulting from genetic factors, anatomic factors, autoimmune~     disorders, endocrine dysfunction, thrombophilia, life style factors, and maternal infections.~     However, the underlying causes remain undetermined in up to 50% of cases. In this clinical~     cohort study, we intended to get an epidemiological evidence for patients with recurrent~     spontaneous abortion associated with thrombophilla.~   "
44049|NCT02990234|"~     The Investigator's hypothesis is that capsular repair (after CAM or mixed Femoroacetabular~     Impingement (FAI) surgery) requiring moderate capsulotomy, would result in similar patient~     outcomes in the short, mid and long term, both clinically and radiographically, compared to~     those without capsular repair. The objective of this clinical trial is to evaluate the~     clinical efficacy with regards to pain, range of motion and return to work and activities of~     daily living. Secondary objective is to evaluate radiographic characteristics between both~     groups.~   "
44112|NCT02989389|"~     The main purpose of this study is to investigate the safety of LY3323795 and the effects it~     has on the body. The study drug or placebo (sugar pill) will be given by mouth to healthy~     participants. The study has three parts. Each participant may only enroll in one part. The~     study will last 14 to 43 days, depending on the part. Screening must be completed prior to~     study start.~   "
44113|NCT02989376|"~     The aim of this study is to address the usefulness of carotid duplex ultrasound as vascular~     imaging for selecting acute stroke patients for endovascular thrombectomy.~   "
44038|NCT02990377|"~     In recent years in the U.S., problems associated with opioid prescriptions, including~     non-medical use and overdose, increased to historically unprecedented levels and represent a~     public health crisis. Emergency departments (EDs) play an important role in opioid~     prescribing, particularly to individuals at high risk for adverse opioid-related outcomes.~     The purpose of this study is to determine whether a new mobile health (mhealth) intervention~     can assist people in the safe use of opioid analgesic (OA) medications after leaving the~     emergency department (ED).~      The specific aims of this project are to: (1) adapt and enhance an existing motivational~     intervention to decrease non-medical opioid use after an ED visit by optimizing intervention~     intensity and duration through reinforcement learning (RL); (2) examine the impact of an~     RL-supported intervention on non-medical opioid use level during the six months post-ED~     visit; and (3) examine the impact of the RL intervention on the opioid-related behaviors and~     adverse outcomes of driving after opioid use, overdose risk behaviors, and subsequent~     opioid-related ED visits. The secondary aims of this project are to: (SA1) examine whether~     baseline level of non-medical opioid use moderates the effects of the intervention; and (SA2)~     understand barriers and facilitators of implementation of the intervention based on~     qualitative interviews with ED patients.~   "
44039|NCT02990364|"~     Circumcision is a commonly performed procedure on newborn males. Clear recommendations and/or~     guidelines for pain control during the procedure do not exist. The purpose of this research~     is to compare various forms of analgesia to evaluate which is the more effective for pain~     reduction. The investigators hope that this study can provide definitive guidelines on the~     best form of analgesia to use during circumcision. It is important that we perform this study~     to ensure that in the future newborns' pain during circumcision is effectively managed.~   "
44040|NCT02990351|"~     This study aimed to analyze the outcomes of loco-regional treatment prior Living Donor Liver~     Transplantation in patients with HCC.~   "
44041|NCT02990338|"~     Primary Objective:~      To demonstrate the benefit of isatuximab in combination with pomalidomide and low-dose~     dexamethasone in the prolongation of Progression Free Survival (PFS) as compared to~     pomalidomide and low-dose dexamethasone in patients with refractory or relapsed and~     refractory multiple myeloma (MM).~      Secondary Objectives:~        -  To evaluate the Overall Response Rate (ORR) as per International Myeloma Working Group~          (IMWG) criteria in each arm.~        -  To compare the Overall Survival (OS) between the two arms.~        -  To evaluate the Time To Progression (TTP) in each arm.~        -  To evaluate the Progression Free Survival (PFS) in high risk cytogenetic population in~          each arm.~        -  To evaluate the Duration of Response (DOR) in each arm.~        -  To evaluate the safety in both treatment arms.~        -  To determine the Pharmacokinetic profile of isatuximab in combination with pomalidomide.~        -  To evaluate the immunogenicity of isatuximab.~        -  To assess disease-specific and generic health-related quality of life (HRQL), disease~          and treatment-related symptoms, health state utility, and health status.~   "
44042|NCT02990325|"~     The purpose of the ABX464-005 study is to characterize the systemic and mucosal immunological~     sequelae associated with exposure to ABX464 and to explore selected immunological endpoints,~     compartmental pharmacokinetics, and pharmacodynamics.~   "
44043|NCT02990312|"~     The purpose of this proof of concept, pilot study is to determine whether the unique~     combination of the human immunodeficiency virus (HIV) co-receptor antagonist, Maraviroc, and~     the mammalian target of rapamycin (mTOR) inhibitor, Sirolimus, in HIV-infected kidney~     transplant recipients has an impact on chemokine receptor 5 (CCR5) density, the~     HIV-reservoir, or rejection of the transplanted kidney. 15 HIV-infected kidney transplant~     recipients will be recruited and their immunosuppressant regimen will be changed to include~     an mTOR inhibitor (such as Sirolimus) unless they are already on one. In addition, Maraviroc~     will be added to their HIV regimen, unless they are already on Maraviroc. Blood will be taken~     to measure markers of the HIV reservoir, their CCR5 density and expression, and immune~     activation.~   "
44044|NCT02990299|"~     The purpose of this research study is to determine the benefit and cost of including health~     coaches, clinical pharmacists and mobile health (mHealth) tools such as text messaging and~     videoconferencing in diabetes management support services for African-Americans and Latinos~     with uncontrolled Type 2 Diabetes.~   "
44045|NCT02990286|"~     The purpose of the study is to evaluate the efficacy on lung function 6 months after one~     course of rituximab (2 infusions) and mycophénolate mofétil (MMF) treatment compared to one~     course of placebo and 6 months of MMF treatment in a broad range of patients with~     Interstitial Lung Diseases (ILD) non-responders to a first line immunosuppressive treatment.~   "
44046|NCT02990273|"~     Cirrhosis results in decreased synthesis of both procoagulants and anticoagulants resulting~     in rebalanced homeostasis. However, conventional blood tests (platelets/ INR levels) that~     are performed prior to invasive procedures do not accurately reflect the coagulation changes~     that occur in cirrhotics, resulting in unnecessary transfusion of blood products.~     Thromboelastography (TEG) is a global hemostasis assessment tool that is being used in~     surgery (including liver transplant) to help guide blood product transfusion in the operating~     room. The investigators would like to compare the use of TEG vs. INR/platelets to help guide~     blood product transfusion in cirrhotic patients undergoing inpatient endoscopy. The~     investigators will evaluate to see if there is a decrease in prophylactic blood transfusions~     prior to endoscopy when using TEG.~   "
44047|NCT02990260|"~     The aim of the study is to evaluate the effect of the consumption of a food supplement (live~     saccharomyces cerevisiae) on lipidic profile in moderate hypercholesterolemic subjects.~   "
44048|NCT02990247|"~     Asthma exacerbations account for a significant morbidity and disproportionate health care~     costs. However, there is no currently available biomarker or lung function parameter that can~     accurately predict the risk of future exacerbations. The current work aims at evaluating the~     resting ventilatory flow by applying a new technique called anharmonic morphological analysis~     of the respiratory signals (AMARS). We hypothesize that monitoring AMARS is potentially able~     to detect an increased risk of asthma exacerbations.~   "
44075|NCT02989896|"~     After a successful peripheral nerve block, blockade of sympathetic nerve fibers results in~     local vasodilatation, increased local blood flow, and increased skin temperature.Increased~     permeability index; Can be used as a reliable tool for evaluating block activity.~   "
44114|NCT02989363|"~     Evaluation of the use of resources and costs with O-arm in deep brain stimulation (DBS)~     surgeries and complex back surgeries~   "
44050|NCT02990221|"~     The main objective of this study is to compare the effectiveness of ingenol mebutate gel (150~     mcg / g per day, to be applied on a predetermined area of 25 cm2 of skin of the face or~     scalp, for 3 days consecutive) cryotherapy (application with 5 seconds of freezing time of~     each lesion located in a predetermined skin area of 25 cm2 of the face or scalp) in the~     treatment of actinic keratosis and their field cancerization.~      Study details:~      This study is randomized. 50 subjects with at least two actinic keratoses of grade I and II,~     located in two different districts of 25 cm2 skin of the face or scalp, and who meet all the~     inclusion criteria will be enrolled in the study by the investigators in the three different~     centers mentioned above.~      The investigators will assess the effect of treatment by confocal microscopy and digital~     dermoscopy. The investigator will acquire images of selected areas of the face and scalp~     before and after treatment. Data will be collected and analyzed by the coordinating centre.~      Procedure for the study:~      Recruitment of subjects; random assignment of treatment (ingenol mebutate gel 150~     micrograms/g and cryotherapy) to the two skin areas of 25 cm2 of the subject recruited;~     evaluation of the two areas with reflectance confocal microscopy and digital dermoscope. The~     measurements will be carried out at time 0, after 1 month and 6 months. The investigator must~     fill out a form for each subject at the beginning (day 0), after 1 month and at the end of~     the study (after 6 months). The subject must complete a questionnaire at the beginning (day~     0), after 1 month and at the last follow-up visit (after 6 months).~      Measurement parameters: Dermoscopy and confocal microscopy will be used to assess the~     percentage reduction in actinic keratoses and the damage of the cancerous area in the two~     selected areas treated with ingenol mebutate gel or cryotherapy, respectively.~      Adverse / side events will be collected at each visit by the investigator and will be~     contained in another form.~   "
44051|NCT02990208|"~     The study investigated the effect of diaphragmatic breathing as an additional coping strategy~     during Virtual Reality Exposure Therapy in patients with aviophobia. The authors assumed that~     diaphragmatic breathing (DB) would lead to less fear and physiological arousal during the~     VRET and to an enhanced treatment outcome~   "
44052|NCT02990195|"~     Multicentre prospective human experimental study to determine the effect of chyme reinfusion~     in patients with a double enterostomy on plasma levels of Fibroblast Growth Factor (FGF19)~   "
44053|NCT02990182|"~     In a previous study by the researchers' group, the researchers' investigate the duration of~     yellow fever post-vaccination immunity in vaccinated children between 9 and 23 months of age.~     However, in this study, samples of children in the pre-vaccine period, also known as~     unvaccinated children samples (NV) have not been investigated. It is believed that to seek~     evidence about the immune status in the medium and long term after vaccination against yellow~     fever is necessary to investigate paired samples of children not vaccinated (NV), with~     re-evaluation 30-45 days after primary vaccination. The proposed study is to consolidate~     aspects of humoral (neutralizing antibodies) and cellular (phenotypic and functional~     parameters of T cells and memory B) by means of complementary longitudinal investigation~     children, 9-23 months old, unvaccinated (NV) and 30-45 days after primary vaccination.~   "
44054|NCT02990169|"~     Prospective, open-labeled, randomized, controlled, multicenter study at two clinical~     investigative sites in Tucson, Arizona. The subjects will undergo intraocular pressure~     measurement with the CATS tonometer prism and the Goldmann applanation tonometer prism (GAT).~     Seventy-five (75) Subjects 18 and older and will be enrolled. Subjects will be screened based~     on standard of care vision examination at the clinical investigation sites. All subjects will~     undergo a standard ophthalmic exam and informed consent. IOP will be measured using a~     Goldmann tonometer armature with both the standard flat GAT prism and the modified curved~     CATS prism alternately inserted. The only additional measurement is central corneal thickness~     (CCT) which is used to correct for one of the corneal biomechanical errors seen in the GAT~     prism and is currently standard of care.~   "
44055|NCT02990156|"~     The scope of this trial is the collection and analysis of effectiveness and safety endpoints,~     related to the use of the MicroPort NeuroTech Coil Embolization System in the treatment of~     intracranial aneurysms.~   "
44056|NCT02990143|"~     The purpose of this study is to investigate whether placing Ologen over the posterior plate~     of the Ahmed glaucoma drainage device during initial implantation will allow the formation of~     a thinner capsule, and decrease the incidence and/or the extent of IOP elevation during the~     postoperative period.~   "
44057|NCT02990130|"~     This proposal aims to characterize biochemical and physiologic factors that contribute to~     changes in patient fitness and body composition during hematopoietic stem cell~     transplantation (HCT) for hematologic malignancies. The study group will consist of 60~     patients with hematologic malignancies treated with HCT. Measurements of patient fitness,~     body composition, and inflammatory milieu will be performed at visits before HCT, and 30 days~     (+/- 10 days) after HCT. For patients that continue to receive care at the Seattle VA,~     additional visits (not exceeding 6 total) may be requested periodically for up to 2 years~     after HCT.~   "
44058|NCT02990117|"~     The introduction of inhaled medication as the primary treatment for asthma has led to~     substantial improvements in asthma control [1, 2]. However, uncontrolled asthma is still~     common and represents a considerable burden to patients and society [3, 4]. An important~     reason for poor asthma control and consequently, increased healthcare expenditure is~     suboptimal adherence to the prescribed regimen [5-7].~      Real-world market research study in hospitals across China reported that physicians perceived~     that only 23% of patients were fully compliant with their medication regime (77%~     non-adherent), compared to 55% in the European Union and 63% in the US [AZ internal~     document]. The physician reported rate of full adherence was lower than the patient-reported~     rate (38%). Poor patient adherence was the challenge most frequently mentioned (by 41% of~     physicians) when treating an asthma.[8]~      However~      There is some evidence on the drivers of patient behaviour around low adherence but more~     depth research is needed~      There is little evidence on variation of determinants of asthma inhaled treatment across~     different age of group~      Our research aims to address above data gap Mean while this research can guide the~     development of new module on Red Scarf patient education program.~   "
44059|NCT02990104|"~     The purpose of this study is to describe the incidence, clinic characteristics, biological~     and suvirval in Lymphoblastic Leukemia patients in Mexico City reference hospitals.~   "
44060|NCT02990091|"~     This is a Phase 2 clinical trial designed to obtain data on relationships between potentially~     therapeutic doses of n-3 HUFA (highly unsaturated fatty acids) and their bioactive molecular~     derivatives, synaptamide, 17-hydroxy-DHA, and D-series resolvins, on clinical outcomes after~     TBI.~   "
44061|NCT02990078|"~     The investigators will longitudinally measure cerebrovascular reactivity (CVR) by functional~     near-infrared spectroscopy (fNIRS) in acute (≤3 days from injury), subacute, and chronic~     phases after TBI as a biomarker of TCVI as compared to healthy controls. CVR will be measured~     by fNIRS response to hypercapnia. The investigators hypothesize that CVR will be decreased~     after TBI and that these decreases will correlate with clinical outcomes. Furthermore, the~     investigators predict that administration of a vasodilatory medication (sildenafil) will~     augment CVR after TBI.~   "
44062|NCT02990065|"~     The purposes of the study are:~        -  To strictly ensure the appropriate level of protein and caloric provision in critical~          illness, according to the latest literature recommendation;~        -  To determine if an association exists between protein intake and nitrogen balance in the~          context of a nutrition with appropriate protein provision based on the latest literature~          recommendations, rather than in a standard diet with a caloric target weight-based.~          Creatinine clearance will also be evaluated to determine if there is any harmful effect~          to the kidney secondary to an elevated BUN.~        -  To determine if there is a difference in ICU mortality rate between the current~          nutrition standard and a hyperproteic nutrition protocol.~   "
44063|NCT02990052|"~     A prospective, randomized controlled single-center trial with 80 patients aged 50 years and~     above to compare the functional and radiological results of conservative treatment and volar~     fixed-angle plating in the management of distal radius fracture~   "
44064|NCT02990039|"~     The purpose of this study was (i) to develop a brief counseling letter intervention aiming to~     reduce sedentary time and to increase physical activity during leisure time among adults aged~     42 to 64 years and (ii) to provide information on the feasibility.~   "
44065|NCT02990026|"~     Specialty mental health probation for offenders with severe mental illness has been widely~     disseminated; however, randomized studies are needed to determine its effectiveness. The~     purpose of the study is to test the feasibility and efficacy of specialty mental health~     probation (SMHP) for probationers with mental illness in North Carolina. 320 adult~     probationers with mental illness in will be randomly assigned to specialty mental health~     probation (experimental condition) or usual probation (control condition). Probationers~     assigned to the experimental condition will be supervised by specialty mental health~     probation officers, who will have reduced caseloads and advanced training in mental health~     and other topics. Probationers assigned to the control condition will receive standard~     probation. Criminal justice and mental health outcomes will be examined.~   "
44066|NCT02990013|"~     Aim 1: To determine in vivo capability of AvenovaTM against common cutaneous microbial biome~     on human skin~      Aim 2: To compare to povidone-iodine 5% solution, 4% chlorhexidine and isopropyl alcohol~     against AvenovaTM as a sterile skin agent~   "
44067|NCT02990000|"~     Research has shown that mental health care (MHC) providers differ significantly in their~     ability to help patients. In addition, providers demonstrate different patterns of~     effectiveness across symptom and functioning domains. For example, some providers are~     reliably effective in treating numerous patients and problem domains, others are reliably~     effective in some domains (e.g., depression, substance abuse) yet appear to struggle in~     others (e.g., anxiety, social functioning), and some are reliably ineffective, or even~     harmful, across patients and domains. Knowledge of these provider differences is based~     largely on patient-reported outcomes collected in routine MHC settings.~      Unfortunately, provider performance information is not systematically used to refer or assign~     a particular patient to a scientifically based best-matched provider. MHC systems continue to~     rely on random or purely pragmatic case assignment and referral, which significantly waters~     down the odds of a patient being assigned/referred to a high performing provider in the~     patient's area(s) of need, and increases the risk of being assigned/referred to a provider~     who may have a track record of ineffectiveness. This research aims to solve the existing~     non-patient-centered provider-matching problem.~      Specifically, the investigators aim to demonstrate the comparative effectiveness of a~     scientifically-based patient-provider match system compared to status quo pragmatic case~     assignment. The investigators expect in the scientific match group significantly better~     treatment outcomes (e.g., symptoms, quality of life) and higher patient satisfaction with~     treatment. The investigators also expect to demonstrate feasibility of implementing a~     scientific match process in a community MHC system and broad dissemination of the easily~     replicated scientific match technology in diverse health care settings. The importance of~     this work for patients cannot be understated. Far too many patients struggle to find the~     right provider, which unnecessarily prolongs suffering and promotes health care system~     inefficiency. A scientific match system based on routine outcome data uses patient-generated~     information to direct this patient to this provider in this setting. In addition, when based~     on multidimensional assessment, it allows a wide variety of patient-centered outcomes to be~     represented (e.g., symptom domains, functioning domains, quality of life).~   "
44068|NCT02989987|"~     Throughout the last 10 years Narrative Exposure Therapy (NET) has evolved as one of the most~     effective, culturally sensitive trauma interventions. In the present study the effectiveness~     of NET delivered by trained health personnel in a sample of survivors of sexual and gender~     based violence (SGBV) who suffer from Posttraumatic Stress Disorder (PTSD) will be assessed.~     Structured baseline, 3 and 6 month follow up interviews will be administered to assess the~     main outcome measures PTSD and shame. The trial will take place in Goma, DR Congo, where SGBV~     and its sequelae has been a major problem.~   "
44069|NCT02989974|"~     The objective of the Kentucky LEADS Lung Cancer Survivorship Care Program is to develop,~     administer and evaluate the impact of a comprehensive psychosocial survivorship care program~     for individuals diagnosed with lung cancer and their caregivers to improve lung cancer~     survivorship and delivery of high-quality lung cancer care. The investigators hypothesize~     that the Kentucky LEADS Lung Cancer Survivorship Care Program will demonstrate improved~     quality of life, better symptom control, increased tobacco treatment, and reduced distress~     among lung cancer survivors and their caregivers.~   "
44070|NCT02989961|"~     The purpose of this study is to determine the safety of Resticutis for the treatment of~     Wagner's Grade II/III diabetic foot ulcers in comparison with Platelet-Poor Plasma as a~     placebo comparator.~   "
44071|NCT02989948|"~     A prospective, single-arm, traditional feasibility study of a physician-modified fenestrated~     Cook Zenith TX2 aortic endograft base device in adult patients meeting traditional size~     criteria for open surgical treatment of thoracoabdominal aortic aneurysms. Patients meriting~     surgical treatment of their aneurysm that also meet inclusion and exclusion criteria will be~     eligible for enrollment. Patients will be followed for 5 years post procedure. Major adverse~     events will also be recorded by the Sponsor-Investigator and will be monitored by a locally~     appointed Data Monitoring Committee, the Colorado Multiple Institutional Review Board, and~     the FDA.~   "
44072|NCT02989935|"~     This study examines the effect of the ultra long acting beta agonist/corticosteroid~     bronchodilator combination fluticasone furoate/vilanterol trifenatate, on respiratory muscles~     and ventilation in adults with severe bronchitis or emphysema (COPD).~   "
44073|NCT02989922|"~     This a randomized controlled Phase 2/3 study to evaluate the efficacy and safety of SHR-1210~     in subjects with advanced HCC who failed or intolerable to prior systemic treatment. The~     primary study hypothesis is that SHR-1210 treatment improves Objective Response Rate and~     Overall Survival when compare with SOC.~   "
44074|NCT02989909|"~     Prospective, open-labeled, randomized, controlled, multicenter study at two clinical~     investigative sites in Tucson, Arizona. The subjects will undergo intraocular pressure~     measurement with the CATS tonometer prism and the Goldmann applanation tonometer prism (GAT).~      Of the 200 eyes, at least 10 highly astigmatic eyes (>3 D of corneal astigmatism) each in the~     low, medium and high IOP ranges shall have the same clinical testing and analysis of results,~     with the analysis kept separate from that of the main group.~   "
44076|NCT02989883|"~     Esophageal outflow obstruction is characterized by failure to relax the lower esophageal~     sphincter (LES), resulting in impaired flow of ingested food into the stomach. The subsequent~     stasis of ingested food leads to symptoms of dysphagia, regurgitation, chest pain, and weight~     loss. The core objective of the treatment of esophageal outflow obstruction is to disrupt the~     LES and reduce its pressure to allow esophageal emptying. Therapeutic options include~     pharmacologic therapy, Botulinum toxin injection, pneumatic balloon dilation, and surgical~     myotomy with partial fundoplication. In addition, peroral endoscopy myotomy (POEM) has~     recently been introduced as a minimally invasive treatment, but there have a few studies~     regarding long-term outcomes. The aim of this study is to evaluate clinical outcomes of POEM~     for esophageal outflow obstruction.~   "
44077|NCT02989870|"~     This study involves a course of radiation to up to 5 tumors in the participant's liver~     followed by systemic therapy. (Treatment using substances that travel through the~     bloodstream, reaching and affecting cells all over the body.) The type of radiation is called~     stereotactic body radiation therapy (SBRT). The purpose of this study is to compare the~     effects, good and/or bad, of different doses of SBRT given along with the systemic therapies,~     sorafenib and bavituximab. The researchers want to see which dose of radiation will work best~     in stimulating the immune response and provide local control to the participant's liver. The~     usual treatment for hepatocellular carcinoma that is unresectable can be transarterial~     therapy, sorafenib alone and/or clinical trial.~   "
44078|NCT02989857|"~     Study AG120-C-005 is a Phase 3, multicenter, randomized, double-blind, placebo-controlled~     study of orally administered AG-120. Subjects, all personnel involved in the evaluation of~     subjects' response to treatment (e.g., Investigators, study coordinators, study pharmacists),~     and designated Sponsor team members will be blinded to study treatment. Subjects are required~     to have a histologically-confirmed diagnosis of IDH1 gene-mutated cholangiocarcinoma that is~     not eligible for curative resection, transplantation, or ablative therapies prior to~     enrollment.IDH1 mutation testing will be performed at participating investigative sites.~     Subjects must have progression of disease and have received at least 1 but not more than 2~     prior treatment regimens for advanced disease (nonresectable or metastatic). All subjects~     must have received either a gemcitabine or a 5 fluorouracil (5-FU) based chemotherapy~     regimen.~   "
44079|NCT02989844|"~     This is a multi-center, phase II clinical trial to prevent relapse using interleukin-15~     (IL-15) super-agonist complex (ALT-803) maintenance after allogeneic hematopoietic cell~     transplantation (alloHCT) in acute myelogenous leukemia (AML) and myelodysplastic syndrome~     (MDS).~   "
44080|NCT02989831|"~     The purpose of this study is to investigate the effects of vibrating insoles on vibration~     perception threshold (VPT) and balance of people with diabetic neuropathy.~   "
44081|NCT02989818|"~     The aim of this multi-center study is to prospectively document the clinical utility of ESD.~   "
44082|NCT02989805|"~     This study will compare the effectiveness of professional and peer care managers in improving~     linkage to and engagement in outpatient care after an emergency department (ED) discharge, as~     well as the mechanisms by which engagement occurs. The study will use a multi-site randomized~     trial study design across 8 EDs in South Carolina with telepsychiatry programs; each site~     will have one professional care manager (social worker or nurse) and one peer specialist care~     manager. Eligible subjects at each site will be randomized to a one-year treatment engagement~     intervention, the Coordination, Access, Referral and Evaluation (CARE) Program with either a~     peer or professional care manager, resulting in a total of 1000 participants across sites.~     The CARE program will focus on shared decision-making between care managers and patients, and~     combines the traditional medical model of care management with a recovery-based approach.~     Follow-up interviews at baseline, 6 months and 12 months will assess outpatient treatment~     engagement after discharge from the ED, changes in mental health and clinical outcomes, and~     changes in attitudinal and logistical barriers to obtaining services.~   "
44083|NCT02989792|"~     Patients having completed former trials T1001-01 or T1001-02 will undergo one blood sampling~     for genotyping purposes. In addition they will compete the personality questionnaires they~     had completed in the former trial.~   "
44084|NCT02989779|"~     Neurokinin (NK) -1 antagonist will be administered to study patients in a double-blind~     placebo trial. Patients receive assessments including Anger Disorder Scale (ADS) and Modified~     Overt Aggression Scale (MOAS) and perform computerized study tasks during MRI before the~     trial begins. Patients receive either one week of the drug or one week of placebo and perform~     the same tasks and assessments. Then patients receive another week of the alternate pill,~     followed by another round of tasks during MRI and assessments.~   "
44085|NCT02989766|"~     This intervention would be a series of self-help-style educational and motivational activity~     sheets for patients to complete independently. This will be a randomized clinical control~     trial.~      Subjects will complete a pre delivery questionnaire and a postpartum questionnaire. Subjects~     in the intervention arm will complete 3 activity sheets prenatally during their wait time at~     the clinic. The first worksheet can be completed the day of recruitment after consent is~     signed.~      Subjects will be contacted by phone at 3 and 6 months postpartum to assess long term duration~     of breast feeding.~   "
44086|NCT02989753|"~     This study is designed as a pilot study in order to estimate the effect of VAL070-A and~     VAL070-B products and their variability on LDL cholesterol and lipid metabolism since these~     data are still unknown for these products and in this specific population. Collected data~     will provide more reliable information which may be used to plan a subsequent larger main~     study.~   "
44087|NCT02989740|"~     Title:~      Combined Optical Coherence Tomography Morphologic and Fractional Flow Reserve Hemodynamic~     Assessment of Non-Culprit Lesions to Better Predict Adverse Event Outcomes in Diabetes~     Mellitus Patients COMBINE (OCT-FFR) Prospective Register~      To study the natural evolution of patients with at least one intermediate angiographic but~     non-hemodynamic significant stenotic lesion, in two subgroups of patients, with TCFA vs. no~     TCFA as detected by OCT imaging and to compare these two groups of patients with each other~     as well as to a subset of patients with FFR-positive and PCI-treated intermediate lesions on~     future MACE.~   "
44751|NCT02981056|"~     The objective of the study is to investigate the effects of different skincare regimens on~     infants (0-6 months old at the start of the study), specifically focusing on moisturization~     effect. Outcome measures include moisturization, skin pH, skin barrier, physiological~     parameters, reactivity and skin microbiome.~   "
44089|NCT02989714|"~     This will be a single arm, multi-site phase Ib/II clinical trial of standard doses of High~     Dose Interleukin-2 (HD IL2) (600,000 IU/kg/dose intravenously during two 5-day cycles 9 days~     apart) in IL-2 eligible clear cell metastatic RCC (Renal Cell Carcinoma) subjects in~     combination with Nivolumab.~      Investigators hypothesize that concurrent PD-1 inhibition synergistically enhances the~     anti-tumor immune response to HD IL-2 in metastatic clear cell RCC. Investigators postulate~     that the combination of the two therapies would result in an increase in the overall response~     rate, complete response rate, and improved survival outcomes compared to either of the~     individual therapies.~   "
44090|NCT02989701|"~     Sickle cell disease (SCD) is one of the most common genetic diseases in the world. In North~     America, an estimated 2600 babies are born with SCD each year1, and approximately 70,000 to~     100,000 individuals of all ages are affected in the United States2. The clinical~     manifestations of SCD include acute events, such as recurrent debilitating painful crises, as~     well as life-threatening pulmonary, cardiovascular, renal, and neurologic complications. The~     only established curative treatment for SCD patients is allogeneic hematopoietic stem cell~     transplant (HSCT). Unfortunately, access to this intervention is limited by availability of~     suitable matched donors, and HSCT is associated with significant morbidity and mortality. For~     patients who cannot undergo HSCT, treatment of SCD has been limited to one FDA-approved~     medication, hydroxyurea, and supportive symptomatic care. After decades with very few novel~     therapeutic options for SCD patients, autologous cell-based genetic therapies, including~     lentiviral-based gene therapy as well as gene editing, now offer the possibility of~     innovative curative approaches for patients lacking a matched donor for hematopoietic stem~     cell transplantation.~      Gene therapy for sickle cell disease is increasingly promising, and there are currently open~     clinical trials at several centers that employ a gene addition strategy.~      Options for autologous HSC collection include bone marrow harvest or peripheral blood HSC~     mobilization. Bone marrow (BM) harvest is an invasive procedure requiring anesthesia, which~     is associated with sickle cell-related morbidities, and may not achieve goal CD34+ cell dose,~     necessitating repeated procedures scheduled over multiple months. In most gene therapy~     trials, HSCs are obtained through peripheral collection after mobilization with granulocyte~     colony-stimulating factor (G-CSF) followed by peripheral blood (PB) apheresis. However, this~     approach is contraindicated in SCD because G-CSF has been reported to cause severe adverse~     effects in sickle cell patients. Even with doses sometimes smaller than standard, G-CSF has~     been shown to result in vaso-occlusive crises, severe acute chest syndrome, and in one~     report, massive splenomegaly and death. Alternative options for mobilization are needed.~      Plerixafor has been compared to G-CSF in a sickle cell mouse model, and results showed~     effective mobilization of HSC subsets, without neutrophil or endothelial activation, and with~     lower total WBC and neutrophil counts compared to G-CSF-treated mice. Plerixafor use has not~     yet been documented in sickle cell patients. One other trial is currently open to test~     plerixafor in SCD patients (NCT02193191) but no results have yet been reported. Based on~     pre-clinical data, the mechanism of action of plerixafor, as well strategies the investigator~     will employ to mitigate risk, the investigator anticipates that it will be well-tolerated in~     the SCD patient population.~   "
44091|NCT02989688|"~     Patients with kidney, or renal, failure require life-saving treatment with regular dialysis.~     Dialysis is a form of treatment that simulates some kidney functions; to remove harmful waste~     products and extra water from the blood. Almost one-third of people with kidney failure also~     have diabetes, as diabetes is one of the leading causes of kidney disease in the United~     Kingdom, usually due to poor blood sugar control over a long period of time. Malnutrition is~     common in patients needing dialysis due to kidney failure causing fatigue, taste changes and~     a build up of waste products, which can reduce appetite. Treatment of malnutrition involves~     increasing both the energy and protein intake from food and drinks, and milk-drink style~     specialist nutrition drinks are often given to dialysis patients due to their specific~     dietary needs. These nutrition drinks can increase blood sugar levels and optimal control for~     diabetes may be difficult. This research study aims to measure the blood sugar response to a~     slow-release sugar nutrition drink specifically designed for dialysis patients, which may~     result in a lower blood sugar level, compared to standard nutrition drinks, consumed during a~     dialysis session. 28 patients with diabetes and having regular dialysis treatment will enrol~     in the study. Patients will be asked to drink 1 of 3 different nutrition drinks, once a week~     for 3 weeks during their regular dialysis treatment. Blood sugar levels will be measured from~     the blood samples taken from the patient's circulation directly before it enters the dialysis~     machine over 3 hours and the maximum blood sugar reading and total blood sugar response will~     be measured. Differences between the 3 drinks will be tested statistically. The results will~     help to advise patients with diabetes and kidney failure on the most suitable type of~     nutrition drink to consume during dialysis.~   "
44092|NCT02989675|"~     The purpose of this study is to evaluate the impact of dextrose administration in severely~     sick children admitted to hospital with low-glycaemia.~      The problem: Mortality in children remains high in sub-Saharan African hospitals. While~     antimalarial drugs, antibiotics and other definitive treatments are well understood, the role~     of emergency care with supportive therapies such as maintaining normal glucose and~     electrolyte balances, has been given limited attention. Hypoglycaemia is common in children~     admitted to hospital in low-income settings. The current definition of hypoglycaemia is a~     blood glucose level of less than 2.5mmol/l. Outcomes for these children are poor, with a~     mortality rate of up to 42%. An increased mortality has also been reported among acutely ill~     children with low-glycaemia, defined as a blood glucose level of 2.5-5.0mmol/l. The reason~     for increased mortality rates is not fully understood.~      Study objective: To determine the impact on mortality of a raised treatment cut-off level for~     paediatric hypoglycaemia, from 2.5mmol/l to 5.0mmol/l.~      Methodology: Severely ill children admitted to two central Malawian hospitals; Queen~     Elisabeth Central Hospital, Blantyre and Zomba Central Hospital, with low-glycaemia~     (2.5-5.0mmol/l) will be randomised into intervention or control groups. The intervention~     group will be treated with an intravenous bolus of 10% dextrose 5ml/kg followed by a dextrose~     infusion in addition to standard care while the control group will receive standard care~     only. Children will be followed until discharge from hospital or death. Primary end-point is~     in-hospital mortality.~   "
44093|NCT02989662|"~     In alcohol use disorder (AUD) and matched healthy control (HC) men and women, the proposed~     research examines the effects of MIFE, with demonstrated preclinical effects on~     drinking-related behaviors, compared with placebo on a breadth of alcohol-related measures.~     All subjects will be randomized to daily MIFE or placebo. Before and during medication, AUD~     and HC subjects undergo fMRI scanning measuring resting-state functional connectivity and~     alcohol cue-induced brain activation focused on brain reward and stress pathways. All~     subjects are admitted to the Clinical Research Unit; AUD subjects undergo supervised alcohol~     withdrawal with daily measurements of alcohol craving and symptom severity. Using validated~     human laboratory procedures in AUD subjects, this study will examine the effects of stress on~     motivation to drink and alcohol sensitivity/reward as a function of GR antagonism.~   "
44094|NCT02989649|"~     The purpose of this study is to observe alogliptin and alogliptin fixed-dose combinations~     (FDCs) utilization patterns, as well as clinical response to treatment with alogliptin or~     alogliptin FDCs, in standard clinical practice.~   "
44095|NCT02989636|"~     This phase I trial studies the side effects of nivolumab with or without stereotactic~     radiosurgery in treating patients with chordoma that has come back or spread from where it~     started to other places in the body. Monoclonal antibodies, such as nivolumab, may interfere~     with the ability of tumor cells to grow and spread. Stereotactic radiosurgery is a~     specialized radiation therapy that delivers a single, high dose of radiation directly to the~     tumor and may cause less damage to normal tissue. It is not yet known whether giving~     nivolumab with or without stereotactic radiosurgery may work better in treating patients with~     chordoma.~   "
44096|NCT02989623|"~     This pilot phase I trial studies how well copper Cu 64 TP3805 positron emission tomography~     (PET) works in detecting prostate cancer in patients with persistently elevated prostate~     specific antigen (PSA). The copper Cu 64 TP3805 PET scan uses copper Cu 64 TP3805, a compound~     made of a radioactive agent attached to a molecule that looks like a hormone that binds to~     cancer cells to detect prostate cancer during PET scans. Copper Cu 64 TP3805 PET may be able~     to see tumors at an earlier stage than the standard of care.~   "
44097|NCT02989610|"~     The purpose of this post market study is to support the chronic clinical performance of the~     Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG), DBS leads,~     extensions and related system components.~   "
44115|NCT02989350|"~     Acute gastroenteritis (AGE) is one of the most common diseases among children. Oral~     rehydration therapy is the key treatment. According to the 2014 guidelines developed by the~     ESPGHAN probiotics may be considered in the management of children with AGE in addition to~     rehydration therapy. Considering that evidence on L reuteri remains limited, the~     investigators aim to assess the efficacy of L reuteri DSM 17938 for the treatment of AGE in~     children. Children vaccinated and not vaccinated against rotavirus will be evaluated~     separately.~      Two independent reports (rotavirus-vaccinated and non-vaccinated children) are planned.~   "
44116|NCT02989337|"~     The purpose of the study is to determine serum inflammatory adhesion molecules levels in~     hyperemesis gravidarum~   "
44117|NCT02989324|"~     Vaginal Misoprostol Versus Combined Low Dose Misoprostol Plus Foley Catheter for Late Second~     Trimester Termination of Pregnancy With Previous Multiple Cesarean Sections~   "
44098|NCT02989597|"~     Methadone has several advantages over standard narcotic medications, especially when~     considering use after a typically painful surgery such as lumbar fusion. Methadone is low~     cost, has a long half-life, has a convenient dosing schedule, has excellent oral~     bioavailability, and demonstrates slow onset to withdrawal. The literature comparing~     methadone to more commonly used post-operative narcotics demonstrates that it manages pain~     better, sustains consistent plasma concentrations, decreases overall narcotic requirement,~     results in no additional adverse events, and is safe, even in children, across several~     studies. Since the standard of care is non-methadone narcotic usage to manage the significant~     pain of complex spinal surgery cases, it is understandable that methadone could be a~     desirable alternative to promote sustained pain control and early ambulation in these~     patients. The goal of this study is to compare the effect of a single dose of methadone~     administered intraoperatively in enrolled spinal fusion patients to their historical controls~     given fentanyl and morphine, and determine if more sustained pain control during the first~     few days after surgery provides a better subjective experience for the patient with less~     pain, which allows them to ambulate and leave the hospital sooner than patients given a~     standard regimen.~   "
44099|NCT02989584|"~     The purpose of this study is to test the safety of the study drug, atezolizumab, when~     combined with the standard chemotherapy drugs, gemcitabine and cisplatin (or GC). This study~     will help researchers begin to understand whether combining GC with atezolizumab is better,~     the same, or worse than the usual approach of using GC alone.~   "
44100|NCT02989571|"~     The objective of this study is to compare the effects of intravenous fluid rate on the course~     of labor in nulliparous patients who are undergoing labor induction and have an unfavorable~     cervix. The primary hypothesis is that an increased rate of intravenous fluids will shorten~     the length of labor in patients undergoing induction with an unfavorable cervix.~   "
44101|NCT02989558|"~     Ticagrelor administered with Acetylsalicylic Acid (ASA) will provide better cerebral~     protection from microembolization in the cerebral circulation during Transcatheter Aortic~     Valve Implantation (TAVI) and 30 days afterwards, than Clopidogrel plus ASA. This hypothesis~     will be investigated by measuring the number of High Intensity Transient Signals (HITS) as~     assessed with transcranial Doppler (TCD) on middle cerebral arteries.~   "
44102|NCT02989545|"~     Fecal incontinence (FI), defined as the involuntary passage of stool for more than 3 months~     and is a devastating disease. The negative impact on quality of life has been consistently~     demonstrated. The prevalence of FI is probably underestimated in most studies. Currently~     conservative treatment is only modestly effective and surgical treatment is complex and~     expensive with less than optimal efficacy.~      The investigators developed an anal tape using a commercially available elastic band with a~     special adhesive that is approved for use in the skin. A special design of the tape can be~     applied to the skin surrounding the anus providing support and additional pressure forces to~     the anal sphincter.~      This is a 4 week, prospective, non blinded, cross-over study to explore the efficacy and~     safety of this device in patients with FI. The primary endpoint will be improvement in~     quality of life.~   "
44103|NCT02989519|"~     The purpose of this study is to determine efficacy of vaginal and oral progesterone after~     tocolytic therapy in threatened preterm labor~   "
44104|NCT02989493|"~     Double-blind, placebo controlled, randomized controlled trial (RCT) for Alcohol Use Disorder~     examining the effects of doxazosin, a norepinephrine alpha1 receptor antagonist, on stress~     reactivity and clinical outcomes.~   "
44105|NCT02989480|"~     Arrhythmogenic right ventricular cardiomyopathy (ARVC) is a rare condition in which the heart~     muscle cells especially of the main pumping chamber (the 'ventricle') is replaced by fat and~     scar tissue. Sarcoidosis is a condition that can affect many organs but when it affects the~     heart patches of inflammation can result in scarring, especially of the ventricles. Both~     conditions can cause dangerous heart rhythms and sudden death. Sarcoidosis can be treated~     with inflammation suppressing treatment (steroids), as well as pacemakers and implantable~     defibrillators which shock the heart back to normal rhythm. ARVC is usually treated with~     implantable defibrillators. The diagnosis of either condition can be difficult and indeed~     distinguishing the two can be extremely challenging. Increasingly nuclear scans (PET) are~     used to identify inflammation in the heart in patients suspected of having cardiac sarcoid.~     It is not known whether patients with ARVC have abnormal PET scans.~   "
44106|NCT02989467|"~     This research study is being done to compare the effects of Aprepitant and placebo on fasting~     gastric volume, accommodation volume, satiation (fullness) and gastric emptying.~   "
44107|NCT02989454|"~     Acute stress induced (Tako-tsubo) cardiomyopathy (TTC) or broken heart syndrome, a condition~     typically occurring after acute stress has a death rate similar to heart attacks and is~     frequently associated with long-term symptoms (fatigue and exercise limitation). There are no~     effective therapies. The investigators have recently showed that there is a profound shortage~     of energy in the hearts of Tako Tsubo Cardiomyopathy patients in the days after acute~     presentation with only partial recovery by four months. The investigators would now like to~     establish whether this recovers after at least one year, or persists, and also to investigate~     the mechanisms responsible for exercise limitation after recovery from the acute phase.~   "
44108|NCT02989441|"~     In patients under general anesthesia the investigators wish to investigate association and~     covariance between a peripheral perfusion index as obtained by Radical 7 monitor (Masimo,~     Irvine, CA, USA) and more traditional hemodynamic parameters, ie. invasive blood pressure and~     SV as obtained by LiDCO rapid monitor (LiDCO Ldt., London, UK)~   "
44109|NCT02989428|"~     The aim of this study is to establish whether patients with mild primary hyperparathyroidism~     (PHPT) have an increased risk of cardiovascular diseases. The primary outcome is to determine~     whether arterial stiffness and blood pressure will decrease in patients with mild PHPT~     3-month after parathyroidectomy (PTX).~   "
44110|NCT02989415|"~     The aim of this study is to assess the incidence of postoperative pulmonary complications in~     patients undergoing mechanical ventilation during general anesthesia for robotic surgery, to~     characterize current practices of mechanical ventilation and to evaluate a possible~     association between ventilatory parameters and postoperative pulmonary complications.~   "
44111|NCT02989402|"~     This is a multicenter, prospective, phase IV study evaluating safety, tolerability and~     effectiveness of rivastigmine 27 mg -15 cm2 transdermal patch prescribed in patients with~     severe dementia of the Alzheimer's type as per discretion of treating physician.~   "
44118|NCT02989311|"~     Infants and young children in sub-Saharan Africa have high rates of iron deficiency anemia~     (IDA), which adversely affects their growth and cognitive development. In-home iron~     fortification of complementary foods using micronutrient powders (MNPs) reduces risk for IDA~     by ensuring that the iron needs of infants and young children are met without changing their~     traditional diet. In order to optimize iron absorption timing of MNP consumption might as~     well be important. This is because hepcidin, a key regulator of systemic iron balance, shows~     a circadian increase that may influence morning versus afternoon iron absorption from the~     MNP. Furthermore, a single dose of iron can increase hepcidin levels and potentially inhibit~     iron absorption from a second dose, consumed close in time to the first dose.~      To determine the difference between i) morning versus afternoon iron absorption and ii)~     consecutive versus alternate day iron absorption, investigators will enrol 20 infants from~     Kwale County aged 6-14 months and conduct two studies. In study 1, infants will consume 2~     test meals consisting of maize porridge containing isotopically labelled Ferrous Sulphate in~     the morning and afternoon on 2 days. In study 2, infants will consume 3 test meals consisting~     of maize porridge containing isotopically labelled Ferrous Sulphate on two consecutive days~     and 1 alternate day. In both studies, fourteen days after the last test meal administration,~     a whole blood sample will be collected by venipuncture for iron isotopic analysis. Iron and~     inflammation status parameter will be determined at baseline and endpoint. Hepcidin~     concentrations will be measured before the morning and afternoon meals (study 1) and after~     second consecutive meal (study 2).~      Knowing the effect of time on the expected iron absorption will inform decisions on the ideal~     timing of MNP to cover the infant's requirement for absorbed iron.~   "
44119|NCT02989298|"~     Brief Summary: The investigators are registering all PD patients at recruited hospitals and~     developing a PD database in China. Patients will be followed up every 3 months, and both~     baseline and follow-up information will be collected and input into the registration system.~     The patient survival, technical survival, peritonitis rate, longitudinal changes of residual~     renal function and peritoneum function, and quality of life for PD patients, etc, will be~     compared using the PD database.~   "
44120|NCT02989285|"~     Human Immunodeficiency Virus (HIV) remains in infected patients receiving highly active~     antiretroviral therapy (HAART) for many years. Stopping HAART usually leads to re-emergence~     of small reservoirs of latent (inactive) HIV that reside inside certain types of infected~     cells, that can replicate and cause a full HIV infection. Chronic HIV infection also leads to~     long-term immune activation which is associated with higher incidence of serious non-AIDS~     events including cardiovascular disease and cancers. Thus HIV+ patients must remain on HAART~     indefinitely or replication-competent latent HIV reservoirs must be eradicated.~      The central nervous system (CNS) is a sanctuary site for latent HIV. For example,~     HIV-associated neurocognitive disorders (HAND) develop and persist in about 40% of HIV+~     persons despite long-term HAART and viral suppression in blood and cerebrospinal fluid (CSF).~     Continued CSF immune activation is also frequently observed despite viral suppression. Both~     of these are likely to indicate ongoing low-level HIV replication in the CNS.~      Several strategies to eradicate latent HIV are being explored. One of these, known as shock~     and kill involves awakening latent HIV and inducing replication to make it more~     susceptible to host immune responses and HAART. However, there are several major caveats to~     its application in the CNS such as the risk of triggering a serious immunoinflammatory~     response (e.g., meningoencephalitis) that cannot be easily controlled by HAART. Other~     eradication strategies may also be problematic given that many latency-reversing agents have~     limited penetration of the blood brain barrier and limited efficacy in astrocyte cells. To~     improve the effectiveness of new eradication therapies it will be crucial to develop better~     methods to identify and quantify latent HIV reservoir sites with greater precision.~      To identify potential HIV latency biomarkers in the CNS, the investigators will study HIV+~     patients stable on HAART and virally-suppressed in blood and CSF over 24 months. Because such~     a marker should be associated with HAND or its development without changing significantly~     with HAND progression, half of the sample will have HAND at study entry and half will not.~     Patients will undergo neuropsychological testing and give blood and CSF samples every 6~     months to identify candidate biomarkers and track them prospectively against HAND development~     and progression. MRI brain scan will also occur at study entry and after 24 months.~   "
44121|NCT02989272|"~     It is a prospective, comparative, randomized, double-blind clinical trial whose hypothesis is~     that pre-treatment with magnesium sulfate, due to its action at the neuromuscular~     junction,potentiate the duration of deep neuromuscular block following rocuronium~     curarization in patients undergoing general anesthesia. Magnesium sulphate has gained~     prominence as an adjuvant drug in anesthesia. Its use is associated with potentiation of~     neuromuscular blockade among other functions.~      The deep neuromuscular block is defined as the one obtained by the absence of response to the~     sequence of four Stimuli and the presence of one or more simple stimuli in post-tetanic~     counts . There is no literature description of the role of magnesium sulphate in Duration of~     the deep neuromuscular block obtained after the muscle relaxation of patients with rocuronium~     This study is justified because extending the clinical duration of neuromuscular blockers may~     translate into gains for surgeries that require deep and long-lasting muscle relaxation as in~     laparoscopic and robotic surgeries. This block allows lower inflation pressures of the~     pneumoperitoneum to be obtained, as a result, there is a lower inflammatory and~     cardiorespiratory repercussion for the patient~   "
44122|NCT02989259|"~     In this study, the investigators try to evaluate the efficacy and safety of apatinib in~     advanced non-squamous head and neck cancer and to validate the correlative biomarkers.~   "
44123|NCT02989246|"~     This pilot study tests the feasibility of using a computerized ventilator management protocol~     seeking to encourage lung protective ventilation during the acute phase of ventilation, and~     esophageal manometry based titration of ventilator settings during the weaning phase of~     ventilation, for children with acute respiratory failure. The investigators hypothesize that~     such an approach will reduce time on mechanical ventilation, largely by preserving diaphragm~     muscle function.~   "
44124|NCT02989233|"~     In the present study, 144 children (72 males and 72 females), whose ages ranged between 8-13,~     were divided into 12 equal experimental groups according to their ages and gender. They were~     all considered to have poor hygiene. Only one out of the three different education methods~     (brochure, model or video) was applied to each group. The percentage change in PI, GI, BOP~     and theoretical test points from the baseline to the 6th months were evaluated.~   "
44125|NCT02989220|"~     Some women experience the pain of miscarriage on numerous occasions. Studies show that these~     women experience feelings of anxiety and distress during the early stages of a new pregnancy~     as they worry another miscarriage will occur. This study will investigate whether a coping~     strategy, developed for a similar group of women, would be acceptable and useful to women~     suffering recurrent miscarriage, and reduce the anxiety and worry they experience. A~     secondary aim of the study is to develop a deeper understanding of the experiences and~     feelings of women in the early stages of a new pregnancy, following multiple miscarriages.~   "
44136|NCT02989077|"~     This study will delineate the risk profile of patients with isolated cerebral or coronary~     ischemia and those with combined disease. The study will also evaluate current management~     status of those patients and any unmet needs.This aim is proposed to be achieved by studying~     3 groups of patients with coronary, cerebral or combined ischemia. Anticipated each group to~     be 1000 patients.~   "
44137|NCT02989064|"~     This study will investigate the safety and tolerability of MAGE A10ᶜ⁷⁹⁶T cell therapy in~     subjects who have the appropriate HLA-A2 tissue marker and whose melanoma or bladder or head~     and neck tumor has the MAGE-A10 protein expressed. This study will take a subject's T cells~     and give them a T cell receptor protein that recognizes and attacks the tumors.~   "
44126|NCT02989207|"~     The aim is to perform a randomised feasibility trial preceding a large prospective randomised~     controlled trial (RCT) comparing three surgical methods - trabeculectomy with Mitomycin C~     (MMC), primary Baerveldt tube with MMC and Baerveldt tube without MMC - in black~     African/African Caribbean patients with Primary Open Angle Glaucoma (POAG) living in London.~      The UK Office of National Statistics estimated that among the population of England in 2007,~     approximately 4.3% were of African/African-Caribbean background, while in large cities such~     as London and Birmingham about 20% of the population is of African/African-Caribbean origin.~     For eye units in these cities, managing glaucoma in this population is challenging and we~     need to identify a better alternative to our current standard surgical treatment.~      There is now evidence from one RCT which shows better overall outcomes from tube surgery in~     comparison to trabeculectomy for glaucoma. However, this study did not address black~     populations specifically and did not address the potential role of MMC in tube surgery.~      This feasibility study will enable us to design a fully powered RCT with the aim of~     determining how best to optimise the surgical treatment of POAG in black populations, by~     comparing outcomes in three types of glaucoma surgery.~   "
44127|NCT02989194|"~     This is a Phase 2a randomized, double-blind, placebo-controlled study designed to assess the~     safety and tolerability of VIS410 in subjects with uncomplicated influenza.~   "
44128|NCT02989181|"~     The aim of this randomized controlled study is to investigate the effect of continues~     positive airway pressure (CPAP) treatment in patients with dilated cardiomyopathy (DCM) and~     concomitant obstructive sleep apnea (OSA). The primary endpoint is left ventricular function~     measured by magnetic resonance (improvement of at least 4%) after six months treatment with~     CPAP.~      The secondary endpoints include diastolic dysfunction, cardiovascular biomarkers and quality~     of life.~   "
44129|NCT02989168|"~     This is an open label study in which eligible IPF subjects who are using supplemental oxygen~     at rest will receive GBT440 orally daily.~   "
44130|NCT02989155|"~     The purpose of this study is to determine the need for a blood transfusion during surgery and~     to evaluate the levels of certain proteins in the blood when given tranexamic acid.~   "
44131|NCT02989142|"~     The project focuses on prevention of major pregnancy and birth related complications :~     pregnancy-induced hypertension (PIH), gestational diabetes mellitus (GDM), caesarean section~     (CS), and large-for-gestational-age (LGA), i.e. the birth weight of the baby exceeds the 90%~     percentile of birth weights for the specific pregnancy duration.~      The investigators focus on the pre-conception period, i.e. the pre-conception period of the~     2nd pregnancy in women with an excessive weight gain during their 1st pregnancy, aiming to~     decrease the complications rate in their 2nd pregnancy.~      Women with an excessive gestational weight gain have obtained the extra weight during a~     rather short period of time, e.g. 20 kilos in the last 4 or 5 months of their pregnancy. This~     characteristic distinguishes the target group from the general population with~     overweight/obesity, in whom the extra weight was acquired during many years and independent~     from a pregnancy, making a behaviour change more complex.~      The coaching intervention combines face-to-face counselling with the use of a mobile App~     connected to medical devices (scale and pedometer). The app monitors important indicators~     (weight, eating behaviour, physical activity, mental wellbeing), provides coaching through~     established behavioral change techniques, and is specifically tailored for women with~     excessive weight gain during the previous pregnancy.~      The goal is to decrease the rate of pregnancy and birth-related adverse outcomes in the next~     pregnancy by a healthy life style, starting shortly after their 1st delivery and sustained~     during the next pregnancy.~   "
44132|NCT02989129|"~     The goal of this clinical research study is to learn about the effectiveness of quercetin in~     treating and preventing CINP. Researchers also want to learn if quercetin has an effect on~     participant's quality of life.~   "
44133|NCT02989116|"~     The purpose of this study is to determine whether a daily executive training to cognitive~     inhibition, working memory or mindfulness as compared to an active control condition has a~     near- and far-transfer impact on brain and behavioral measures as collected in children aged~     9-10 years, either born preterm or full-term.~   "
44134|NCT02989103|"~     Background:~      Hyperthyroidism is a common disease. It is very common for women. It is usually treated with~     Radioiodine (I-131). Some people think that this might cause cancer, even many years later.~     Past studies of people with hyperthyroidism have not been clear about cancer risks after~     I-131. Researchers want to look at a group of people with the disease who got I-131 many~     years ago. They want to look at how their health was months and years later.~      Objective:~      To learn more about disease risks in relation to radiation from I-131 treatment for~     hyperthyroidism.~      Eligibility:~      People who were part of the previous study. These are people who were diagnosed with~     hyperthyroidism at U.S. and U.K. hospitals from 1946 to 1964. About 95% of the participants~     have already died.~      Design:~      Researchers will examine data already collected by the past study. This includes data on~     participants later cancers and other health outcomes after they had I-131 treatment.~      Researchers will compare that data to a National Death Index search.~      This was already done for data up through 2003. This study will cover 2004 2014.~      Researchers will not be in touch with study participants or their next of kin....~   "
44135|NCT02989090|"~     Remote monitoring of implantable cardioverter-defibrillators (ICDs) for patients has led to~     efficient, safe, and satisfying analysis of their device and cardiac status; resulting in an~     overall improvement in the quality of care for such patients. Despite the efficacy of remote~     monitoring of ICDs and the satisfaction of patients and providers with the process, there is~     a desire from patients to have access and view ability of the data their ICD is transmitting.~     However, methods for making ICD device data directly available to the patients are not~     currently in place. This study aims to elicit the impact of standardized remote monitoring~     ICD data to patients through an electronic personal health record (ePHR) on patient~     engagement, healthcare utilization, and patient-provider communication. For this study,~     patients with an ICD manufactured by St. Jude Medical and that are undergoing remote~     monitoring through the remote management system, Merlin.net™, will receive a standardized~     format of their electronic remote monitoring ICD data in MyChart, the ePHR used at Parkview~     Health. The standard format for the electronic remote monitoring ICD data, as it is delivered~     to the patient, will be termed the ICD Patient Notification Summary. Additionally, provider~     attitudes and perceptions regarding the value of the Patient Notification Summary, its impact~     on clinic workflow, and patient-provider communication will be collected.~   "
44138|NCT02989051|"~     Rationale: Fluid overload is a common complication in children who are admitted to the~     pediatric intensive care for mechanical ventilation. Acute lung infection is a frequent cause~     for admission to the PICU and forms an uniform group with a single organ failure. In these~     critically ill children, fluid overload is associated with adverse outcome. Restricting the~     volume of fluids already in an early stage of ICU admission may prevent fluid overload during~     mechanical ventilation and thus improve clinical outcome. However, at the same time fluid~     restriction may interfere with appropriate energy and macronutrient intake that is needed for~     recovery.~      Objective: The main goal of this pilot study is to evaluate the feasibility of a restrictive~     fluid management protocol and investigate its effect on the occurrence of fluid overload in~     mechanically ventilated children with acute infectious lung disease.~      Study design: Single-center prospective randomized feasibility and pilot study in preparation~     of a multi-center randomized controlled trial (RCT).~      Study population: Mechanically ventilated children with (suspicion of) acute infectious lung~     disease admitted to the pediatric intensive care unit (PICU) of the Emma Children's Hospital,~     Academic Medical Center, Amsterdam.~      Intervention: Patients receive either liberal (control group) or a restrictive (experimental~     group) fluid treatment, while ensuring appropriate caloric intake.~      Main study parameters/endpoints: Primary outcomes are cumulative fluid balance and body~     weight during the first week of mechanical ventilation. Secondary outcomes (in preparation of~     the larger multi-center RCT) include: mortality, duration of mechanical ventilation and~     oxygenation indices. To determine the feasibility, in- and exclusion rate, adherence to~     treatment arms, need for fluid bolus, need for diuretics and hemodynamic indices as well as~     energy and protein intake are studied.~      Both fluid management protocols reflect a variant of current clinical practice, hence will~     not provide extra burden or risk to patients included in the study. Patients will be~     randomized to either of the fluid protocol arms on admission to the PICU (at start of~     mechanical ventilation). Patients included in the restrictive fluid treatment arm might have~     direct benefit from the study if indeed fluid overload is less common in this group.~   "
44139|NCT02989038|"~     The purpose of this study is to evaluate reactions to, and choices to self-administer,~     cigarette smoke with varying nicotine content among low-frequency, non-dependent~     adolescent/young adult smokers between the ages of 18-25 years.~   "
44140|NCT02989025|"~     The purpose of this study is to learn if giving 17-hydroxyporgesterone caproate (17 OHPC) to~     mothers with preeclampsia diagnosed before 34 weeks gestation improves mother and baby~     outcomes.~   "
44141|NCT02989012|"~     Randomized, double-blind, double- simulation, positive drug-and-Placebo-Controlled,~     multicenter, phase IIa clinical trials Study about GanMaoKangNing Granules in improving the~     symptoms of influenza.~   "
44142|NCT02988999|"~     Prospective, randomized, double-blind, controlled-trial 30 subjects in each groups Group - I~     consume pure D-allulose 5 g 3 times a day before meal to right after meal (with any liquid)~     and Group - II control group with non-calorie sweetener erythritol 5 g 3 times a day before~     meal to right after meal (with any liquid) Total number: n = 60 Either males or females,~     non-diabetic, aged > 18 years old with BMI ≥ 25 kg/m2~      Primary objectives Efficacy~      1. Compare the efficacy of pure D-allulose (psicose) plus conventional therapy on 1.1~     visceral fat area (VFA), subcutaneous fat area (SFA), total fat area (TFA) change 1.2 body~     weight, BMI and body fat percentage (with impedance method) change after 24 weeks of~     D-allulose (psicose) consumption to erythritol consumption and between pre- and~     post-intervention.~      Secondary objectives 1. Efficacy of pure D-allulose (psicose) plus conventional therapy~     versus erythritol plus conventional therapy on 1.1 insulin resistance, fasting plasma~     glucose, HbA1c 1.2 adiponectin, leptin and tumor necrosis factor-alpha, lipid profiles (total~     cholesterol, HDL-C, LDL-C, triglyceride, very low-density lipoprotein, LDL, chylomicron),~     apolipoprotein AI, apolipoprotein AII,apolipoprotein B48, apolipoprotein CIII and~     apolipoprotein E, free fatty acids 1.4 waist circumference, hip circumference, waist/hip~     ratio~      Safety~      1. Safety of the study by comparing with conventional therapy, monitoring blood pressure,~     pulse rate, hematological parameters and urinalysis~   "
44143|NCT02988986|"~     This is an open label phase II clinical trial to determine the efficacy, toxicity, and safety~     of TAK-228 plus tamoxifen in patients with newly diagnosed ER-positive, HER2-negative breast~     cancer.~   "
44144|NCT02988973|"~     The objective of this study is to evaluate the efficacy and safety of ASP1517 when converted~     from recombinant human erythropoietin (rHuEPO) or darbepoetin alfa (DA), compared to DA in~     the treatment of anemia in non-dialysis chronic kidney disease patients. Another uncontrolled~     cohort will be included to evaluate the efficacy and safety of ASP1517 in patients converted~     from epoetin beta pegol (CERA). This study will also assess the safety/efficacy of long term~     treatment of ASP1517 (52 weeks).~   "
44145|NCT02988960|"~     This is a dose-escalation study designed to evaluate the safety, pharmacokinetics, and~     pharmacodynamics of ABBV-927, and to determine the maximum tolerated dose (MTD) or~     recommended Phase 2 dose (RPTD) for ABBV-927 when administered as monotherapy or as~     combination therapy with ABBV-181 in participants with advanced solid tumors.~   "
44146|NCT02988947|"~     The purpose of this study is to evaluate the effectiveness of a combined Pain Neuroscience~     Education (PNE) and Hypnosis (HyP) psychological intervention aiming at the control and~     prevention of pain and promotion of post-surgical recovery in patients undergoing Total Knee~     Arthroplasty~   "
44147|NCT02988934|"~     The purpose of this study is to create a registry (collect data and keep it in a research~     database) to learn more about two methods of taking small tissue samples from your esophagus~     (the esophagus is the tube that carries food and liquid from your mouth to your stomach.).~     The two methods of sampling are: 1) Using forceps that take biopsies (small tissue samples)~     from your esophagus, and 2) Using a brush that also takes biopsies from your esophagus.~      By recording the results of all of your biopsies over many years, it may be possible to find~     out if the brush biopsy, forceps biopsy, or both can predict which patients with heartburn~     develop Barrett's esophagus, (an abnormality in the esophagus that may lead to cancer), and~     which patients with Barrett's esophagus develop precancer and cancer. The data from your~     biopsies will be used to determine the best way to diagnose esophageal disease.~      You are being asked to participate in the study because you are receiving an upper endoscopy~     (a procedure where a tube with a light and camera are inserted in your mouth and down your~     throat) with forceps and brush biopsies of your esophagus as part of your standard clinical~     care, and you are between the ages of 18 and 80.~   "
44148|NCT02988921|"~     Magnetic resonance imaging (MRI) with functional features of diffusion weighted imaging (DWI)~     are advancing imaging technologies that have potential to overcome limitations of~     conventional staging methods, radiation treatment planning and the assessment of tumor~     response in esophageal or esophagogastric cancer. This study aimed to explore the value of~     MRI for the prediction of tumor response to chemoradiotherapy and accurate target volume~     delineation as compared to CT simulation for patients with unresectable or potentially~     resectable esophageal or esophagogastric cancer undergoing chemoradiotherapy. The average CT~     texture features are also extracted before and during treatment to establish a model to~     predict the prognosis or side effects (e.g. radiation pneumonitis or esophagitis) of~     patients.~   "
44149|NCT02988908|"~     A comparison of memory training with and without donepezil.~   "
44150|NCT02988895|"~     This is a prospective, single-arm, open-label, safety, usability and tolerability trial of~     Strontium 90 (Sr90) beta radiation episcleral brachytherapy in subjects receiving aflibercept~     therapy pro re nata (PRN) for the treatment of early neovascular Age-related Macular~     Degeneration (nAMD) lesions. Secondary aims are to observe clinical outcomes of area of~     leakage, sub-retinal fluid, lesion size, visual acuity, and anti-vascular endothelial growth~     factor (anti-VEGF) treatment burden.~   "
44151|NCT02988882|"~     The objective of the study was to evaluate the efficacy and safety of OTX-DP (dexamethasone~     insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the~     treatment of the signs and symptoms of chronic allergic conjunctivitis~   "
44152|NCT02988869|"~     The overall objective is to asses the bronchodilator effect of once daily~     Tiotropium/Formoterol combination delivered via Discair® by comparing Tiotropium (q.d.)~     monotherapy delivered via Handihaler and tiotropium (q.d.) delivered via Handihaler +~     formoterol (b.i.d) delivered via Aerolizer free combination treatment in patients with stable~     moderate to severe COPD.~      Spirometric measurements (FEV1, FVC) will be performed for a period of 24 h at 12 different~     times: pre-treatment (15 min prior to the first dose) and post-treatment (30. min, 60 min [1~     hr], 120 min [2 hr], 180 min [3 hr], 240 min [4 hr], 360 min [6 hr], 480 min [8 hr], 600 min~     [10 hr], 720 min [12 hr], 840 min [14 hr],1440 min [24 hr].~   "
44153|NCT02988856|"~     Objective 1: Determine the safety and feasibility of externally mounted magnets for extended~     management of chronic eyelid movement disorders by measuring visual acuity and corneal and~     skin integrity and comfort over 8 weeks of wear. Objective 2: Collect preliminary data on the~     relative efficacy of external magnetic devices by comparing them to externally mounted lid~     weights and ptosis crutches using rating scales and video analysis of blink biomechanics.~   "
44154|NCT02988843|"~     This is a multi-center phase II study of brentuximab vedotin in combination with bevacizumab~     for the treatment of refractory CD-30+ germ cell tumors (GCT) after disease progression on~     imaging and/or tumor marker progression documented by serially rising alpha-fetoprotein (AFP)~     or beta human chorionic gonadotropin (bHCG) measured on at least 2 consecutive visits and~     determined by treating physician to be clinically significant. Patients unable to receive 2nd~     line of platinum-based chemotherapy due to toxicity or refusal would also be eligible.~   "
44155|NCT02988830|"~     The aim of the study is to show that subcutaneous electric lumbar stimulation reduces pain in~     chronic lumbago after 12 months of treatment.~   "
44156|NCT02988817|"~     The purpose of the trial is to determine the maximum tolerated dose and to establish the~     safety profile of HuMax-AXL-ADC in a mixed population of patients with specified solid tumors~   "
44157|NCT02988804|"~     The endoscopic endonasal transsphenoidal surgery (EETS) is widely used. Although the~     incidence of complications is low, hypertensive episodes during surgery and awakening and~     cerebro spinal fluid (CSF) leakage have been described. The occurrence of coughing or~     vomiting during the early postoperative period must be avoid to protect the patient from CSF~     leakage and arterial hypertension. The emergency of anesthesia with laryngeal mask has a~     better haemodynamic profile and less incidence of cough in some surgical procedures and it~     could help minimizing the risks after EETS~   "
44158|NCT02988791|"~     Infantile colic (IC) criteria includes all of the following in subjects aged ≤ 4 months:~     paroxysms of irritability, fussing, or crying that start and stop without obvious cause;~     episodes lasting 3 or more hours per day and occurring at least 3 days per week for at least~     1 week; and no failure to thrive. The condition is very common in the first 4 months of life~     (10-30 % of infants) with a peak prevalence at 6-8 weeks and is characterized by excessive~     and inconsolable crying without an identifiable cause. Infantile colic cause considerable~     stress for the baby and the family, huge medical expenses (the IC cause 10-20 % of all~     pediatric visits in the first 4 months of life) and frequent formula changes.~      The pathophysiology of IC is still poorly defined, but differences in gut microbiota~     composition seem to be involved. In particular, differences in the number and species of~     Lactobacilli spp, Klebsiella spp and Escherichia coli spp have been demonstrated in subjects~     with IC, and it has been postulated that these alterations could be responsible for an~     abnormal gas production within gut lumen resulting in distension and abdominal pain. These~     findings suggest the potential role of probiotics as preventive and therapeutic strategy for~     the IC.~   "
44159|NCT02988778|"~     This study is to evaluate non inferiority of Eurofarma budesonide nasal spray x referral~     Astrazeneca budesonide. Half patients will receive Eurofarma medication and half patients~     will receive Astrazeneca medication. There is no placebo group.~   "
44160|NCT02988765|"~     Vulvar cancer is a rare and very aggressive cancer, mainly spreading through lymphatics, in~     which the preoperative evaluation is critical to address surgery between sentinel node biopsy~     or radical groin lymphadenectomy.~   "
44161|NCT02988752|"~     This study was a non-inferiority trial with masked data analysis. Individuals ranging from 18~     to 60 years from both genders that met the pre-defined criteria were included. This study was~     carried out in Recife at Clinica Oftalmologica Zona Sul and at Centro de Informatica-UFPE.~     Using both equipment, 5 vertical cup-to-disc ratio (VCDR) evaluations were performed for each~     eye of the individuals, under midriatic conditions. Evaluations were done by examiners who~     did not know previously results obtained from other equipment. Data was collected by the main~     researcher of this research. This study was approved by the ethics committee before it~     started and all research members signed the TCLE agreement. The statistical test employed in~     this study was Pearson Correlation test.~   "
44162|NCT02988739|"~     It is the aim of the present study to compare the immunogenicity induced by a laser-assisted~     epidermally administered seasonal influenza vaccine to an intradermally administered seasonal~     influenza vaccine.~   "
44163|NCT02988726|"~     RATIONALE: Current therapies for adults with a recurrent/residual Neurofibroma or Schwannoma~     provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy~     suggest that it may prove beneficial in the treatment of adults with a recurrent/residual~     Neurofibroma or Schwannoma.~      PURPOSE: This study is being performed to determine the effects (good and bad) that~     Antineoplaston therapy has on adults with a recurrent/residual Neurofibroma or Schwannoma.~   "
44164|NCT02988713|"~     This is a prospective, multi-center, non-randomized, exploratory, single-arm study~     characterize the effects of programming spinal cord stimulation (SCS) in patients undergoing~     a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial~   "
44165|NCT02988700|"~     Caudal analgesia along with general anesthesia is a very popular regional technique for~     prolonged postoperative analgesia in different pediatric surgical procedures where the~     surgical site is sub-umbilical. Caudal anesthetics usually provide analgesia for~     approximately 4-6 hours.~      Recently, the use of spinal anesthesia in infants and children requiring surgeries of~     sub-umbilical region is gaining considerable popularity worldwide.~      - The ease of performance and the safety regarding cardio-respiratory functions makes spinal~     anesthesia as an alternative to general anesthesia in infants and children undergoing~     surgeries of sub-umbilical regions.~   "
44166|NCT02988687|"~     This PILOT, NON-INTERVENTIONAL STUDY will follow patients about to start rhGH for a period of~     six months and collect valuable pilot data to evaluate feasibility of a larger study and~     treatment tolerability and compliance. The effect of rhGH on cognitive function, depression,~     fatigue, sleep quality, and QOL will also be collected. This exploratory study will also~     provide important information about recruitment and AGHD screening procedures in military~     settings.~   "
44167|NCT02988674|"~     The objective of this study is to access retention rate, persistence and adherence in~     population of spondylarthritis (SpA) (ankylosing spondylitis (AS) and psoriatic arthritis~     (PsA)) participants treated with adalimumab in routine clinical settings in the Russian~     Federation.~   "
44168|NCT02988661|"~     The purpose of this research is to examine whether the Chronic Disease Self-management~     Program (CDSMP) would improve health outcomes and reduce health care use in African American~     women with systemic lupus erythematosus (SLE). The CDSMP is a generic, evidence-based~     self-management education program that has been shown to help people with chronic conditions~     to take control of their health problems. This study focuses on African American women with~     SLE because the CDSMP has not been widely studied in this population.~   "
44169|NCT02988648|"~     The purpose of this phase I/II study is to evaluate the safety and clinical activity of~     Radioiodide (131I-) as a novel targeted therapy for metastatic breast cancer that~     overexpresses functional Na/I symporter. The study will enroll patients with metastatic~     breast cancer who have had clinical and/or radiographic evidence of disease progression on~     prior hormonal and/or chemotherapy.~   "
44170|NCT02988635|"~     This study compares two types of care - Standard Oncology Care (SOC) and SOC with early~     palliative care (EPC) (started within 8 weeks after diagnosis of advanced disease) to see~     which is better for improving the quality of life of patients with advanced lung, pancreas,~     gastric and biliary tract cancer. The study will use FACT-G questionnaire to measure~     patients' quality of life.~   "
44171|NCT02988622|"~     The purpose of this study is to compare the 1550-nm non-ablative Fraxel laser (referred to as~     Fraxel Laser in this application) to the ablative 10,600-nm carbon dioxide fractional laser~     (referred to as CO2 Laser in this application) to determine if one is superior to the other~     in improving the appearance of scars over a series of three treatments. In addition, the~     investigators hope to identify a more cost-effective method to improve the appearance of~     scars caused by surgery or trauma.~   "
44172|NCT02988609|"~     This study assess the putative persistence of neural damage using resting state fMRI after~     concussion in rugby player once they have clinically recovered. The hypothesis is that~     despite a clinical recovery (absence of symptoms; neurological and neuropsychological~     examination returned to normal) connectivity map obtained using resting state fMRI are~     significantly different from a group of control subjects.~   "
44173|NCT02988596|"~     Approximately 420 professional and amateur athletes will participate in rehabilitation during~     recovery after sports-related concussion. Participants will be cluster randomized, by study~     site, to a specific study arm. Participants will complete post-injury assessments and the~     intervention of their randomized group aimed at understanding the effects of a~     multidimensional rehabilitation protocol versus enhanced graded exertion on clinical~     recovery, return to play, and patient outcomes after sport related concussion~   "
44174|NCT02988583|"~     Silicone oil has been used as a surgical tool in complicated retinal detachment surgery.~     There are some complications occurring in pars plana vitrectomy with silicone oil tamponade.~     Silicone oil emulsification is one of the complication that may result in severe sequels that~     are difficult to treat. It is believed that low viscosity silicone oil has more risk to~     develop emulsification than high viscosity silicone oil. Up to now, however, there is no~     conclusive guideline that which types of silicone oil is suitable for these complicated~     retinal detachment surgeries and what is the appropriate time to remove the oil. This~     prospective study aims to study the silicone oil emulsification comparing between low~     viscosity and high viscosity silicone oil after complicated retinal detachment surgery.~   "
44175|NCT02988570|"~     In recent years, several studies confirm that some of preterm children have language~     developmental disabilities, in production, in comprehension, or in written language. These~     language impairments lead to learning disabilities. There are, however, contradictions~     concerning the origin and nature of language dysfunctions. Some studies find lexical~     disorders (number of words used by the child), others preferentially phonological disorders~     (sounds used in the language), others also disorders of the morphosyntaxe (organization of~     the sentences) and fragilities that affect pragmatics (understanding situations).~      The computer-evaluation of the language is carried out at five and a half year coupled with~     the medical and neuropsychological examinations. The language assessment lasts 30 to 45~     minutes per child. It is carried out using a laptop computer that allows the submission of~     stimuli and recording of the child's responses. The language evaluation scale is the battery~     CléA (Pasquet F et al, 2014), standardized reference tool for the realization of a language~     evaluation. The assessment includes three tests: comprehension of words and phrases,~     production of words and phrases, and judgment of sentences. Each time, the child sees images~     and hears words or phrases. Sometimes he has to say what he sees on the computer screen.~      As usual, a speech-language assessment is not carried out, routinely, at the age of 5 years~     in the context of the follow-up of children born very preterm.~      The evaluation proposed to the child in this research will be carried out at a significant~     period of development, before writing. This assessment will not only assess the structure of~     the child's language, but also determine if there are possible difficulties in learning to~     read and write.~      The expected benefits for the health of the children included in the trial therefore concern~     the detection or characterization of any developmental fragilities affecting the language.~     These screenings or characterizations will make it possible to advocate a speech~     rehabilitation if necessary.~   "
44176|NCT02988557|"~     The adaptations in kinematics and muscle activity, investigated by 3D gait analysis and~     dynamic electromyography recordings, will be studied in children with bilateral spastic~     cerebral palsy during level walking, and before and after a training on a treadmill with a~     sloped surface (7°). Data will be compared with those obtained in a sample of typically~     developing (TD) children (controls)~   "
44798|NCT02980445|"~     The purpose of this study is to determine whether improved outdoor time has an effect on the~     onset and progression of myopia in children.~   "
44177|NCT02988544|"~     The aim of the study is to determine if collapsing an embryo (or making it fold compactly by~     taking away its fluid) before the transfer in the uterine cavity improves pregnancy rates in~     assisted reproductive technology (ART).~      Women coming to our ART center will be randomized in two groups : the collapsing group and a~     control group.~      Pregnancy rates will be compared in the two groups. A biomarker (cell free DNA) will also be~     determined in each group and correlated to pregnancy occurrence.~   "
44178|NCT02988531|"~     To determine whether PET-MRI can obtain comparable images to PET-CT in those with coronary~     artery disease.~   "
44179|NCT02988518|"~     Bipolar disorder is a major health concern. Intercritical periods are marked with residual~     symptoms, both thymic and cognitive, which affects quality of life of patients, but also the~     quality of observance. The implementation of cognitive remediation programs could be~     interesting. The aim of this study is to evaluate the overall performance on euthymic bipolar~     patients with memory complaints included in the program named COGMED, targeting the working~     memory.~      The impact of this program on compliance, quality of life, and memory complaints will be~     evaluated.~      The investigator will measure whether there is a correlation between working memory and~     overall performances.~      Finally, the investigator will try to achieve a profile of bipolar patients in whom the~     Cogmed program is particularly effective on a plan of overall performance.~   "
44180|NCT02988505|"~     Lymphedema is a frequent and chronic condition posing a high burden on patients. Clinical~     guidelines emphasize the role of compression therapy by prescription medical devices. Even in~     a mandatory publicly funded health insurance system, out-of-pocket payments (OOPP) may exist~     due to the price and reimbursement setting processes. OOPP may threaten the equity of care~     and drive patients to forgo care. Our aim was to analyze the distributive effects of OOPP for~     lymphedema patients in France.~      A prospective, multicenter study will be conducted in France in 2014 on patients with~     lymphedema. Household ability to pay will be specified by net income and OOPP will be~     assessed prospectively over 6 months for outpatient care (visits, drugs, medical devices,~     nursing care, biological tests, imaging, physiotherapy and transportations). Both mandatory~     and voluntary health insurance reimbursements will be considered. We will combine~     concentration curves and concentration indices to assess the distributive effects.~   "
44181|NCT02988492|"~     The newest generation of stent--‐retrievers results in higher recanalization rates and faster~     recanalization time compared to older generation endovascular therapies for acute stroke.~     Advanced neuroimaging can potentially improve the assessment of infarct core and inform~     decision--‐making in patients being considered for endovascular therapy. Evaluation of~     infarct core may be performed with NECT, CTASI or CT perfusion. In the past, evaluation of~     CTP in predicting core infarct in acute stroke has been limited because recanalization status~     was lacking. In addition, final infarct size may be underestimated on NECT compared with MRI.~     These two limitations can now be addressed: the new generation of stent--‐retrievers allows~     accurate determination recanalization time; evaluating the test characteristics of CTP using~     24 hour DWI--‐MRI as the reference standard can be readily performed.~      We aim to prospectively investigate the sensitivity and specificity of whole--‐brain CTP in~     predicting 24 hour DWI--‐MRI infarct in patients with acute proximal anterior circulation~     occlusions successfully recanalized with endovascular treatment.~   "
44182|NCT02988479|"~     Primary lymphedema is a chronic condition posing a high burden on patients. Clinical~     guidelines emphasize the role of compression therapy by prescription medical devices. Even in~     a mandatory publicly funded health insurance system, out-of-pocket payments (OOPP) may exist~     due to the price and reimbursement setting processes. OOPP may threaten the equity of care~     and drive patients to forgo care. The investigators aim was to analyze the distributive~     effects of OOPP for primary lymphedema patients in France.~      A prospective, multicenter study will be conducted in France in 2015 on patients with primary~     lymphedema. Household ability to pay will be specified by net income and OOPP will be~     assessed prospectively over 6 months for outpatient care (visits, drugs, medical devices,~     nursing care, biological tests, imaging, physiotherapy and transportations). Both mandatory~     and voluntary health insurance reimbursements will be considered. The investigators will~     combine concentration curves and concentration indices to assess the distributive effects.~   "
44183|NCT02988466|"~     This is a single institution phase II study of a reduced intensity conditioning (RIC)~     followed by a haploidentical hematopoietic cell transplant (haplo-HCT) in persons with~     diagnosis of hematologic malignancy. Conditioning will consists of fludarabine,~     cyclophosphamide, melphalan and total body irradiation (TBI) preparative regimen with a~     melphalan dose reduction for patients ≥55 years old and those with HCT Comorbidity Index (CI)~     >3. This study uses a two-stage phase II design with accrual goal of 44 patients, using 22~     patients separately for arms A and B.~   "
44184|NCT02988453|"~     A single blind, randomized controlled trial to investigate the efficacy of a newly manualized~     psychotherapy Mentalization-Based Training for Adolescents with Conduct Disorder (MBT-CD)~     in comparison with Treatment As Usual (TAU).~   "
44185|NCT02988440|"~     A two part study to determine the maximum tolerated dose and/or recommended phase 2 dose of~     PDR001 in combination with sorafenib in patients with advanced hepatocellular carcinoma in~     first line. There will be a dose escalation part and a dose expansion part.~   "
44186|NCT02988427|"~     We will develop a new measure of patient engagement/activation specific to the context of~     diabetes self-care~   "
44187|NCT02988414|"~     Prospective study at Duke University Hospital comparing the Karius Infectious Disease~     Diagnostic Sequencing Assay to blood culture results in admitted patients with~     bacteremia/septicemia.~   "
44188|NCT02988401|"~     This study will evaluate if giving insulin that is administered in the nostrils (intranasal)~     is safe and tolerable for people with multiple sclerosis (MS). It is also being done to~     evaluate if intranasal insulin improves cognitive function in people with MS and to evaluate~     how it might be working.~   "
44214|NCT02988063|"~     This study evaluates the addition of polidocanol endovenous microfoam (PEM) to compression~     therapy to determine effectiveness in improving the healing of venous leg ulcers (VLUs) in~     adults with severe venous disease of the great saphenous vein (GSV). All participants will~     receive treatment with Varithena and compression therapy.~      The purpose of this study is to assess whether the use of PEM to correct superficial axial~     and varicose vein reflux is effective in improving healing of VLUs, over treatment with~     compression alone.~   "
44189|NCT02988388|"~     The LTRC will facilitate histopathological research of pulmonary diseases by collecting lung~     tissues from donors and preparing and distributing collections of tissue specimens to~     researchers within and outside the LTRC. Collections of specimens will be linked to~     individual clinical data appropriate to the particular disease. The primary goal of the LTRC~     is to identify participants with suspected lung cancer or metastatic disease who are willing~     to provide informed consent for research use of their specimens and data. Secondarily, the~     LTRC investigators intend to collect clinical data, limited exposure data, physiologic~     studies, and radiographic studies from these participants.~   "
44190|NCT02988375|"~     The primary objective of the proposed research is to determine the efficacy of Digital~     Cognitive Behavior Therapy (dCBTI) in reducing severity of depression and also in preventing~     the incidence and relapse of depression among insomniacs. In addition, we will identify~     salient sociological/environmental variables, such as age, sex, education, socioeconomic~     status (SES), racial/ethnic minority-status, work schedule, child-care responsibilities~     (i.e., having children under the age of 3), stigma, that moderate the effects of this~     intervention.~   "
44191|NCT02988362|"~     The purpose of this study is to compare the safety and pharmacokinetics of HL068 (Candesartan~     16 mg and Amlodipine 10mg) with coadministration of the two separate drugs in healthy male~     volunteers.~   "
44192|NCT02988349|"~     caries-free (CF) individuals caries-active (CA) individuals (DMFT ≥ 6) will be recruited.~     Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate®~     Sensitive Pro-Relief® toothpaste (containing 8% arginine and 1450 ppm NaF) for 2 weeks.~     Supra- and subgingival plaque, saliva, and in situ plaque samples will be collected before~     and after the treatment for laboratory analyses.~   "
44193|NCT02988336|"~     The purpose of this study is to assess the usefulness of the Thyromental Height Test in~     prediction of difficult intubation using double lumen endotracheal tubes in patients~     scheduled for elective thoracic procedures.~   "
44194|NCT02988323|"~     Sport concussions are among the most commonly occurring injuries in sport and recreation and~     pose significant public health implications for Canadians. Many individuals who sustain a~     concussion recover in the initial 7-10 days but up to 74% of youth and 31% of adults may~     suffer from persistent symptoms. Little research is currently available evaluating the~     effects of treatment for individuals who are slower to recover following sport-related~     concussion. An initial RCT identified a significant treatment effect in individuals with~     persistent symptoms of dizziness, neck pain and/or headaches following sport-related~     concussion when treated with a combination of cervical and vestibular physiotherapy compared~     to a typical protocol of rest followed by graded exertion (Schneider et al, 2014). Low level~     aerobic exercise in combination with sport specific training may also be of benefit to~     facilitate recovery in children and youth following concussion (Gagnon et al, 2009, 2016).~     Further evaluation of these treatments is required to better understand the effects of each~     treatment in isolation and in combination. This trial will have the ability to inform future~     multifaceted clinical trials as well as clinical practice. Ultimately, identification of~     optimal treatment paradigms will lead to a decrease in persistent symptoms and functional~     alterations in children and youth from this commonly occurring injury.~   "
44195|NCT02988310|"~     Twelve individuals with above knee limb loss, 12 individuals with below knee limb loss,15~     healthy individuals will be participants of the study. Participants with lower limb loss will~     evaluate with the following assessment tools: Demographic datas; age, gender, height, body~     mass will be recorded. Gait parameters (step length, variation of step length, time on each~     foot, ambulation index) will evaluate with Gait Trainer Biodex 2, at participant's preferred~     speed.~   "
44196|NCT02988297|"~     The purpose of this study is to determine whether nebulized RNS60 is effective in the~     treatment of amyotrophic lateral sclerosis (ALS).~   "
44197|NCT02988284|"~     Three hundred healthy individuals will be participants of the study. Participants will~     evaluate with the following assessment tools: Demographic datas; age, gender, height, body~     mass, will be recorded. Gait parameters (step length, variation of step length) will evaluate~     with Gait trainer Biodex 2, at participant's preferred speed.~   "
44198|NCT02988271|"~     Meditation is an approach that focuses on the connection between mind and body that uses~     techniques with breath, sound, or movement. It has been the focus of research because of its~     possible benefit for lowering distress and improving health and quality of life. The~     meditation techniques in this study are already used in clinical practice. They are based on~     the Tibetan tradition and focus on use of sound and breathing techniques.~      The goal of this research study is to learn how self-administered meditation (meditation you~     complete on your own) can improve your mood-related symptoms, such as depression and anxiety.~     Researchers also want to learn how to deliver pre-recorded meditations using a computer-based~     application (program, or app).~      This is an investigational study. The use of meditation for anxiety in cancer patients is~     considered investigational. The lead researcher can explain how meditation is designed to~     work.~      Up to 30 participants will be enrolled in this study. All will take part at MD Anderson.~   "
44199|NCT02988258|"~     The study will test the hypothesis that CMV TCR-transduced T cells, at a specific T-cell~     dose/kg, can generate a functional CMV immune response post-transplant, where CMV-specific~     donor T cells cannot be isolated by conventional means. This will be tested in the context of~     adult HLA-matched sibling allogeneic HSCT.~      In the proposed trial, an HLA-A*0201-restricted CMV pp65-specific T cell receptor (TCR) will~     be introduced into donor T cells via ex vivo GMP retroviral transduction. Donor T cells will~     be isolated from peripheral blood following a simple venesection procedure. The CMV~     TCR-transduced T cells will be tested for TCR expression, CMV-specific cytokine secretion and~     microbiological contamination before being frozen and stored at -80C. CMV seropositive~     transplant recipients will be tested weekly for CMV reactivation by quantitative PCR on~     peripheral blood. On first detection of CMV DNA > 200 copies/ml, 104 (cohort 1) or 105~     (cohort 2) bulk CMV TCR-transduced T cells/kg recipient weight will be infused into the~     patient.~      Blood will be taken regularly to determine persistence and expansion of the CMV~     TCR-transduced T cells. Weekly CMV PCR will be continued. Patients will be examined at~     appropriate intervals (daily if inpatients, twice weekly in BMT clinic if outpatients) for~     the development of graft versus host disease (GVHD) or other potential side effects.~   "
44200|NCT02988245|"~     Hypertension is one of the most important preventable contributors to disease and death in~     the United States and represents the most common condition seen in the primary care setting.~     Approximately 78 million adults living in the U.S. have hypertension with more than 5 million~     new diagnoses made each year. Unfortunately, despite a significant impulse in the medical~     community to move towards an individualized medicine approach to patient centered~     treatment, the current clinical treatment strategy is based on a set algorithm which does not~     take into account individual patient differences. As a result hypertension is often~     sub-optimally treated based on population averages, rather than a person's genetic make-up,~     with significant burden on our health care system. In fact, 40% of patients who are adherent~     to their blood pressure therapy (taking their medicines as prescribed by their clinician) do~     not have their blood pressure under control. Previous work has demonstrated significant~     functional polymorphisms within the kidney, vessels, and heart that will likely predict a~     patient's response to blood pressure pharmacotherapy. Previous work by our group, utilizing a~     retrospective design, has determined that the addition of genetic knowledge to prescribing~     can improve therapeutic guidance and decrease the time to blood pressure control~     significantly. Despite this, to date, there are no prospective trials to guide blood pressure~     therapy using multiple organ systems that are important in the three most common classes of~     drugs: diuretics, vasodilators, and beta-blockers. The objective of this clinical trial is to~     determine the efficacy of genetically guided therapeutic options for pharmacologic treatment~     of essential hypertension in newly diagnosed patients.~   "
44201|NCT02988232|"~     The Purpose of this trial is to investigate the efficacy and safety of~     Sogyeonghwalhyeol-tang(SGHH) on Korean Patients With Work Related Chronic Low Back Pain~   "
44202|NCT02988219|"~     This study evaluates the incidence of cardiac arrhythmias during the perioperative period in~     patients undergoing open kidney cancer surgery in the lateral position. All the participants~     will be randomly allocated to receive general (Group G) or combined epidural/general~     anaesthesia (Group G/E). The anaesthetic technique is standardized. The Holter monitor will~     be applied at the evening before the surgery, tracing continuously for a period of 24 hours~     (7PM-7PM)~   "
44203|NCT02988206|"~     In this study，researchers will use personalized objects to assess patients' level of~     consciousness in chronic patients in minimally conscious state (MCS).~   "
44204|NCT02988193|"~     The purpose of the PRECISION study is to compare a clinical reasoning artificial intelligence~     for hypertension treatment management with usual care (UC) and enhanced care (EC) in patients~     with poorly controlled hypertension.~   "
44205|NCT02988180|"~     Children in extreme poverty lack adequate care and face increased health risks. The earlier~     poverty strikes in the developmental process, the more deleterious and long-lasting its~     effects. There is, however, growing evidence that early interventions can prevent the~     negative consequences. Such interventions are effective, particularly when they are of high~     quality, organized at home and parents are involved. Recently, baseline assessment of~     developmental and nutritional status of SOS children and children in extreme poverty in Jimma~     region of South-West Ethiopia revealed that these children have developmental problems in~     language, motor, social-emotional skills and nutritional status. The impact of play-oriented~     stimulation activities integrated into the existing SOS basic program, on developmental~     outcomes, has never been investigated in this context. The main objective of the study is,~     therefore, to evaluate the impact of play-oriented stimulation integrated into the basic SOS~     program on the developmental outcomes of children living with foster families. This was done~     by comparing the intervention children with their age-matched children (control), not~     receiving the stimulation package. It was hypothesized that this package would significantly~     improve the developmental skills of these children.~   "
44206|NCT02988167|"~     Knowing when to liberate critically ill patients from mechanical ventilation (i.e.~     extubation) is of great importance as both prolonged ventilation and failed extubation are~     associated with increased morbidity, mortality & costs. The study objective is to improve the~     safety of extubation by harnessing hidden information contained in the patterns of variation~     of heart and respiratory rate measured over intervals-in-time.~   "
44207|NCT02988154|"~     This study aims to investigate the efficacy of simulation in neurosurgical training.~   "
44208|NCT02988141|"~     A Prospective Multi-center Study to Investigate the EGFR-TKI Resistance Profile in Chinese~     Patients with Advanced EGFRm+ NSCLC~   "
44209|NCT02988128|"~     Post market surveillance registry~   "
44210|NCT02988115|"~     The purpose of this study is to determine if bempedoic acid (ETC-1002) is effective and safe~     versus placebo in patients with elevated LDL cholesterol and who are statin-intolerant.~   "
44211|NCT02988102|"~     In pediatric age groups communication difficulties very sometimes may present further~     obstacles in obtaining a detailed injury history and early identification of TBI symptoms.~      Most emergency management protocols are focused exclusively on the identification of the~     relatively small number of patients who may require operative intervention, as early surgery~     is believed to improve outcome.~   "
44212|NCT02988089|"~     Helicobacter pylori (H. pylori), which infects about 50% of the global population, has been~     recognized as a main risk factor of multiple gastric pathologies, especially non-cardiac~     gastric cancer. Strongly evidence supports that H. pylori eradication is an effective~     approach to reduce the incidence of those pathologies.~   "
44213|NCT02988076|"~     This is a prospective, multicenter, randomized, double-blind, controlled study to evaluate~     the effectiveness of Psychiatric Electroencephalogram Registry (PEER) Interactive to inform~     medication prescription in subjects with a primary diagnosis of depression with comorbidity~     of non-psychotic behavioral disorders versus treatment as usual, as determined by the~     investigator. The primary measurement for improvement of the subjects depression will be a~     self-evaluation questionnaire, the Quick Inventory of Depressive Symptomatology-Self Report~     16 , but the investigators will also collect information on their clinical global improvement~     and any reduction in adverse events.~   "
44224|NCT02987933|"~     Resting state fMRI scans of chronic pain sufferers will be compared to those of healthy~     normals and may be sufficiently different to allow a high level of classification accuracy of~     whether subjects have chronic pain. In addition, investigators will utilize DTI and a brief~     activation state using pain rumination to assess whether investigators can reliably find~     differences between chronic pain sufferers and healthy normals.~   "
44215|NCT02988050|"~     Sixty patients were randomly allocated into two groups, group PD and group PR, thirty~     patients in each group. Patients in PD group received propofol and dexmedetomidine~     intravenous infusion and patients in PR group received propofol and remifentanil intravenous~     infusion. Sedation score and patients' satisfaction, surgeon satisfaction, heart rate, mean~     arterial blood pressure, oxygen saturation, and side effects such as respiratory depression,~     nausea, vomiting, airway obstruction, and oxygen desaturation were recorded.~   "
44216|NCT02988037|"~     The investigators conducted a pre-post naturalistic study regarding changes observed~     associated with a 15-week course of an adapted form of dialectical behaviour therapy for~     adolescents. We measured frequency of self-harm prior to treatment and after treatment using~     the Self-Injurious Thoughts and Behaviors Interview. We also measured changes using the~     Suicide Ideation Questionnaire, Life Problems Inventory, Resiliency Scale for Children and~     Adolescents.~   "
44217|NCT02988024|"~     The objects of this study is to assess the relative bioavailability (BA) of 80 mg LY03005~     oral tablets compared to 50 mg Pristiq® oral tablets after a single oral intake under fasting~     conditions in healthy subjects between 18 and 50 years of age.~   "
44218|NCT02988011|"~     In this explorative randomized clinical study, the investigators aim to study metabolic,~     cellular, and molecular changes that occur during weight loss in obese subjects with and~     without type 2 diabetes. Using novel imiomics (imaging technique using PET/MR~     bioinformatics) analyses to examine possible metabolic differences between energy restricted~     diet and gastric by-pass surgery on whole-body and tissue specific insulin sensitivity,~     glucose tolerance, metabolite and protein profiles, fatty acid metabolism, ectopic fat~     content, and gene expression in adipose tissue. This study aims to identify novel biomarkers~     and drug targets for type 2 diabetes as well as validate promising and established biomarkers~     in an interventional model for improved glucose metabolism.~   "
44219|NCT02987998|"~     The purpose of this study is to determine the feasibility and evaluate the safety of~     delivering chemoradiotherapy, the usual approach to non-small cell lung cancer, in~     combination with pembrolizumab (MK-3745), followed by consolidation pembrolizumab after~     surgical resection. Consolidation therapy is treatment given following the initial treatment.~      Pembrolizumab is an investigational drug (also known as Keytruda), which has been approved by~     the FDA for use in certain types of skin cancer (melanoma), and for use in certain types of~     head and neck cancer. However, it has not been approved for use in other cancers such as~     non-small cell lung cancer (NSCLC). Pembrolizumab is a monoclonal antibody that binds to the~     surface of some cells of the immune system and activates them against cancer cells. It is not~     chemotherapy.~   "
44220|NCT02987985|"~     The objective of this trial is to determine whether an opioid-free general anesthetic (OFA)~     technique utilizing ketamine, dexmedetomidine, lidocaine, and gabapentin can help reduce~     postoperative respiratory depression in the post-anesthesia care unit and ward in children~     with sleep-disordered breathing undergoing tonsillectomy when compared with traditional~     opioid-containing techniques. It is expected that this OFA regimen will have a measurable~     reduction on postoperative respiratory depression in children with sleep-disordered~     breathing.~   "
44221|NCT02987972|"~     This study is designed to evaluate the safety, tolerability, and immunogenicity of two~     different lots of V114 in healthy infants 6 to 12 weeks (>=42 days to <=90 days) of age. The~     primary hypothesis of the study is that the proportion of participants receiving V114 who~     have serotype specific IgG >=0.35 mcg/mL for each of pneumococcal serotypes 1, 3, 4, 5, 6A,~     6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F at 1 month after Dose 3 is non-inferior to that for~     recipients of Prevnar 13™.~   "
44222|NCT02987959|"~     This is an open-label phase II study of TAK-228 for patients ≥ 18 years of age with complex~     genomic sarcomas exhibiting Phosphoinositide-3 Kinase (PI3K) pathway dysregulation. Patients~     must have surgically unresectable or metastatic disease that is refractory to at least one~     prior line of therapy (not including neoadjuvant or adjuvant therapy in a curative setting).~     Patients disease must also have evidence of progression prior to enrollment. The purpose of~     this study is to determine the antitumor activity in this group of patients. Patients must~     meet all eligibility criteria as detailed in section 10. A total of up to 33 patients will be~     included in the study. Patients will undergo screening evaluations to determine eligibility~     within 28 days of the first dose. All patients will be required to submit baseline tumor~     samples for analysis. Patients who have had their tumors tested commercially for PI3K/~     AKT/mechanistic Target of Rapamycin (mTOR) alterations will be assessed on a case by case~     basis for eligibility and for determination as to whether additional tissue is required.~      TAK-228 will be administered orally at 3 mg daily for a 21 day cycle. Clinical and laboratory~     assessments will be made on day 1 of each cycle. Disease will be assessed by comparing~     unidimensional tumor measurements on pre and peritreatment imaging (CT or MRI) after weeks 6,~     12, 18 and every 12 weeks thereafter. Response will be assessed according to RECIST 1.1.~     Therapy will continue until disease progression or unacceptable toxicity or withdrawal of~     consent.~   "
44223|NCT02987946|"~     In neurosurgical patients, the risk for venous thromboembolic events (VTE) is high due to the~     relatively long duration of surgery, the high occurrence of prolonged immobilization of~     patients due to paresis of the legs or intracranial pathology causing inability to mobilise2.~     Moreover, intracranial and intraspinal tumours and subarachnoid haemorrhage cause~     hypercoagulability, which increases the risk on VTE. There is a high degree of diversity in~     attributed risk on thrombosis in the neurosurgical patient cohort. Due to this diversity,~     insufficient power of performed studies and lack of careful phenotyping and description of~     risk factors in previous studies on deep venous thrombosis (DVT) prophylaxis, as yet the~     optimal DVT prophylaxis in neurosurgery remains unclear. A prospective randomized study with~     adequate power and detailed information on patient related factors (malignancy, subarachnoid~     haemorrhage, prevailing coagulopathies), type of surgery, duration of surgery, and~     postoperative immobilisation will allow us to identify the optimal treatment strategy for~     high risk neurosurgical patients.~      In the current study all patients that fulfil the inclusion criteria will be subjected to~     post-operative systematic evaluation of VTE by echo-duplex investigation.~   "
44626|NCT02982694|"~     The primary objective of this study is to determine the anti-tumor activity, as measured by~     overall response rate (ORR) of atezolizumab in combination with bevacizumab in patients with~     chemotherapy resistant CRC and positivity for MSI-like molecular signature. This is an~     international, open-label single arm (non-randomized), one-stage phase II trial.~   "
44225|NCT02987920|"~     Total knee arthroplasty (TKA) is one of the most painful orthopedic procedures. After TKA~     surgery, postoperative pain relief may be achieved using a variety of techniques. Integral to~     recovery and improved outcomes is early ambulation and mobilization. Achieving adequate~     postoperative pain control while ensuring the ability to ambulate early can be quite~     challenging.~      Currently, in our country there has been a call to address prescription opioid use and abuse~     due to a nationwide opioid epidemic. In light of this, improving our multimodal analgesic~     protocol will serve to decrease reliance of opioid medications for pain control. Multimodal~     analgesia is effective in decreasing total opioid consumption postoperatively.~     Dextromethorphan is a low-affinity noncompetitive N-methyl-D-aspartate (NMDA) receptor~     antagonist. It has a long history of clinical use with an established safety record. Studies~     have shown that it has a positive effect as an analgesic.~      In order to see if dextromethorphan will decrease opioid use, this study will look at two~     patient groups undergoing total knee arthroplasty with the same preoperative, intraoperative,~     and postoperative anesthetic plan with the exception of the addition of dextromethorphan to~     one groups multimodal analgesic regimen. This study is designed as a double-blinded,~     randomized, prospective cohort trial.~   "
44226|NCT02987907|"~     The current random, double-blind, controlled, clinical trial was designed to evaluate the~     impact on therapeutic effect and tolerance of treatment for patients with hepatocelluclar~     carcinoma in transcatheter arterial chemoembolization (TACE) of dexamethasone application.~   "
44227|NCT02987894|"~     The purpose of this post-market registry is to collect and monitor ongoing safety and~     performance clinical data of the ACURATE neo™ Aortic Bioprosthesis, and the ACURATE TF™~     Transferral Delivery System, when used as per IFU.~   "
44228|NCT02987881|"~     This study will evaluate whether the use of the Jawbone wristband monitor, in connection with~     home-based exercise and nutritional counseling can be safely completed and improve~     cardiorespiratory fitness (heart and lung health) in women with early stage endometrial~     cancer who have undergone surgery.~   "
44229|NCT02987868|"~     In a recent randomized, double-blind, cross-over clinical trial, serum growth hormone (hGH)~     increased 682% above baseline 120 minutes after oral administration of an amino acid-based~     dietary supplement (SeroVital), p=0.01 vs placebo. In contrast to the mechanism of hGH~     stimulation by ghrelin, the investigators hypothesize that the supplement suppresses~     somatostatin, a know inhibitor of both hGH and TSH. To test this hypothesis, the~     investigators measured triiodothyronine (T3) after administration of the amino acid-base~     supplement.~   "
44230|NCT02987855|"~     Reflex Sympathetic Dystrophy (RSD), Complex Regional Pain Syndrome (CRPS), Causalgia, and~     Fibromyalgia represent progressive systemic pain conditions which often worsen over time.~     They appear to be dysregulation of the central nervous system (CNS) and the autonomic system~     (sympathetic/parasympathetic) which cause extensive functional losses, impairment, and~     disabilities. They are often associated with injury sites (including surgical) which produce~     constant, often disabling pain and motor-sensory losses.~      Treatments are often ineffective and include medications (often high dose opiates), Physical~     Therapy (PT), and surgical interventions (sympathectomy, ablation) or insertion stimulators~     of the CNS.~      Study is an interventional study to document the safety and efficacy of use of~     adipose-derived cellular stromal vascular fraction (AD-cSVF) in chronic pain and dysfunction~     disease groups.~   "
44231|NCT02987842|"~     This study protocol proposes an EEG based neurofeedback (EEG-NFB) technique to upregulate the~     posterior cingulate cortex (PCC) in patients suffering from mild cognitive impairment (MCI)~     and early Alzheimer's disease (AD).~      EEG-NFB has been successfully used as a clinical tool for over 40 years. It is based on~     electrical activity measured near the surface of the brain using EEG and fed back to the~     patient within half a second.~      MCI is a clinical condition considered as a precursor of AD. NFB appears to be a promising~     approach to treat MCI, since it has been shown to be able to induce changes in brain~     plasticity. This research focuses on the PCC, which has been reported to be implicated in~     MCI, and due to its location (proximity to the surface) accessible by means of EEG- NFB.~      A preliminary research in MCI patients, conducted at our lab showed the lower the memory~     score was at the beginning of the training, the better a subject managed to improve later on.~     The investigators therefore presume that patients with early Alzheimer's disease, whose~     cognitive ability is more affected compared to MCI, may benefit from EEG-NFB as well, and~     maybe to a larger extent compared to MCI.~   "
44232|NCT02987829|"~     This is a multi-center, first-in-human, open-label, Phase 1/2A dose-escalation study in which~     eligible patients with metastatic castration-resistant prostate carcinoma (mCRPC) will~     receive oral doses of TRC253. The study will be conducted in 2 parts: part 1 (dose~     escalation) and part 2 (dose expansion).~   "
44233|NCT02987816|"~     Recent changes in medical training environments and restrictive work-hour regulations have~     greatly impacted trainees, limiting the number of opportunities to gain proficiency in~     procedural skills. Reports suggest that medical residents lack confidence in their ability to~     perform certain medical procedures, and program directors often do not believe their~     residents can operate independently in major procedures. Simulator based task training (SBTT)~     has provided a safe and ethically appropriate method of skill acquisition but training~     opportunities remain limited. Methods to enhance motor learning during these training~     opportunities have not been described. Transcranial direct-current stimulation (tDCS) is an~     emerging form of non-invasive brain stimulation that has been shown to improve motor~     learning. tDCS has been shown to enhance increasingly complex skill acquisition. The~     investigators propose to examine if tDCS can improve the acquisition and retention of~     neurosurgical skill. The investigators propose a double blind, sham-controlled randomized~     trial applying tDCS during evidence-based SBTT of medical students, to determine if brain~     stimulation can enhance training skill acquisition and retention. Even a modest enhancement~     carries the potential to transform medicosurgical skills training.~   "
44234|NCT02987803|"~     The investigators aim to conduct a randomized controlled trial of women who are pregnant or~     considering pregnancy to understand whether women provided with specific data on~     hospital-level cesarean delivery rates are more likely to select higher quality hospitals,~     defined as hospitals with cesarean delivery rates below the Federal HealthyPeople 2020 target~     of 23.9%.~   "
44235|NCT02987790|"~     The judicious use of antibiotics is one of the main measures to limit the emergence of~     multidrug-resistant pathogen related to excessive antimicrobial use. A recent study~     demonstrated that C-reactive protein (CRP) was as useful as procalcitonin (PCT) in reducing~     the time of antibiotic therapy in adult septic patients treated in the ICU setting.~     Therefore, the present study proposes to compare the time of use of antimicrobials, costs of~     hospitalization and clinical outcomes of interest among a group of antibiotic therapy guided~     by serum levels of CRP and a group of therapy based on the best practices of antibiotic~     therapy (Best Practice).~   "
44236|NCT02987777|"~     The aim of this study was to assess the frequency of PD-L1 expression in stage III-IV ECs and~     to investigate its correlation impact with progression-free survival (PFS), and~     clinicopathological features including microsatellite instability and quantified stromal and~     intraepithelial tumor-infiltrating CD8+ lymphocytes (TILs)~   "
44237|NCT02987764|"~     Premature birth is a major risk factor for perinatal brain damage and cerebral palsy (CP)~     with 47% of all CP cases occurring in infants with birth weight less than 2500 g. CP has~     life-long neurological consequences that affect quality of life for the patient. In the last~     2 decades, improvements in neonatal intensive care have improved survival of VLBW infants~     significantly. This increased survival of VLBW infants poses new challenges towards~     developing novel treatments and interventions to decrease neurodevelopmental impairment and~     CP. While it is common for extremely preterm infant to survive at 23 weeks of gestation, the~     neurologic consequences range from learning difficulties and cognitive defects to severe~     disability and cerebral palsy. Currently prenatal neuroprotective agents such as~     corticosteroids are utilized whenever a preterm birth is anticipated. However, there are no~     proven postnatal interventions to prevent brain damage and cerebral palsy in VLBW infants.~      Many recent studies show that delaying umbilical cord clamping (DCC) may improve hemodynamic~     stability and decrease intraventricular hemorrhage (IVH) in preterm infants. A decrease in~     incidence of IVH has a conceivable prospective benefit of decreasing brain injury and~     improving long-term outcomes. Based on these findings, the American College of Obstetricians~     and Gynecologist and American Academy of Pediatrics endorse that DCC may benefit the preterm~     infants. However, these recommendations have not been adopted by most obstetricians in USA.~     The main concern regarding the practice of DCC is the care delay in initiating resuscitation~     and providing the needed care to this vulnerable population.~      Therefore, as an alternative to DCC, method of cord milking (CM) has been developed to~     provide cord blood transfusion to premature infants. CM offers a more practical alternative~     to delayed cord clamping that may provide the same benefits without the need to delay~     resuscitation. However, there are very few studies of CM in VLBW infants and there is no~     evidence demonstrating long-term neurological outcomes and CP after CM.~      The investigators hypothesize that cord milking in VLBW infants will result in improving~     cerebral oxygenation, function and result in improved long-term neurodevelopmental outcomes~     at 2 years of post-menstrual age. Premature infants born at less than or equal to 32 weeks~     gestation age will receive cord milking after cutting versus standard care of immediate cord~     clamping.~   "
44238|NCT02987751|"~     This study is a multicentre, randomized, open label on comparison of a Long-Acting Basal~     Insulin Analog Glargine plus Glulisine with Premixed Insulin in Adult Patients with Type 2~     Diabetes Mellitus in 200 patients that will be conducted in seven centers in Tamil Nadu. The~     primary outcome measures will be to compare the change in HbA1c from baseline to week 24~     between Glargine OD + Glulisine in comparison with Premixed insulin initiation in insulin~     naïve patients with T2DM. The secondary outcomes is to compare the following in the two arms~     between baseline and 24 weeks Fasting plasma glucose, Postprandial glucose, 7-point~     self-monitored blood glucose (SMBG) profiles, Percentage of participants with HbA1c < 7%,~     Insulin dose, Overall adverse events, Symptomatic Hypoglycemia, Severe hypoglycemic, Weight,~     BMI and Blood pressure.~   "
44239|NCT02987738|"~     Dapagliflozin has a unique mechanism of action that does not directly affect either insulin~     resistance or insulin secretion, but rather improves glycemia by reduction of glucose~     re-absorption from proximal renal tubules. Dapagliflozin is expected to reduce mean daily~     glucose, improve glycemic control and reduce overall insulin requirements. Improved glycemic~     control with reduced variability may also lead to reduced frequency of hypoglycemia.~      In youth with T1D, Dapagliflozin led to a significant reduction of insulin needed to achieve~     target glucose irrespective of preexisting HbA1c levels.~      In this pilot study data will be collected to investigate the effect on glucose of two doses~     of 10mg (each) dapagliflozin within range for the ensuing 24 hours during the DreaMed~     automated insulin delivery in patients with type 1 diabetes dosing with dapagliflozin in an~     in-patient setting combined with an automated sensor based CE marked insulin delivery system~     to data if dapagliflozin is a suitable add-on therapy. This will provide optimal monitoring~     of subject safety and assessment of the effects of dapagliflozin in a structured setting.~      If this inpatient study shows evidence that Dapagliflozin is a suitable add on therapy and~     leads to an increase of time within the target glucose range when using a sensor based~     insulin pump therapy (closed-loop) further outpatient studies are planned to be conducted.~   "
44240|NCT02987725|"~     The purpose of this study is to test the effects of a laboratory-based hypnosis session~     compared to an attention control condition on peripheral blood flow, autonomic stress~     responses, and acute pain responses in adolescents (ages 12-18) with sickle cell disease, and~     examine how perceived disease-related stigma may affect these responses.~   "
44241|NCT02987712|"~     Recently it has been acknowledged that cirrhotic patients present with rebalanced~     hemostasis that results from decreased levels of both pro-coagulant and anti-coagulant~     factors, that is not well reflected by conventional coagulation tests (CCTs).~     Thromboelastography (TEG) might be a more accurate tool in these patients.~      Numerous guidelines on the management of the cirrhotic patient undergoing invasive procedures~     have been published but most of them are not evidence based. Current literature, although~     conflicting, is leaning towards a restrictive approach to prophylactic correction of~     coagulopathy when performing invasive procedures in cirrhotic patients. The investigators~     suspect that common practice is more liberal . Considering the well-known adverse effects of~     blood product administration, the aim of the study is to re-evaluate the clinical management~     of cirrhotic patients undergoing invasive procedures.~      Study objectives: asserting whether the use of blood products prior to invasive procedures in~     cirrhotic coagulopathic patients can be reduced using TEG to evaluate coagulopathy in place~     of CCTs, evaluating the rate of complications due to blood product use, and checking how well~     CCT results correlate with TEG results in these patients.~      This will be a prospective pre/post TEG protocol implementation study which will include two~     prospective surveys with a 1:1 ratio. Survey 1: prophylactic administration of FFP/PLT prior~     to minor invasive procedures will be based on CCTs and physicians' clinical judgement. Survey~     2: management will be based on a new TEG protocol. The investigators will include cirrhotic~     patients with coagulopathy who are candidates for an invasive procedure. Subject will be~     provided with sufficient time to reach a rational, informed decision regarding participation~     in the study.~      Data will be collected from the computer based medical record systems, the patient file and~     directly from the caring physician and will include a thorough medical history and~     conventional blood tests, including a TEG test. All subjects will be managed according to~     standard of care.~      Primary endpoint: amount of blood product (fresh frozen plasma/platelets) units transfused in~     preparation for the invasive procedures.~      Secondary endpoints: bleeding complications, transfusion related side effects, 90 day~     survival and other complications.~      This will be a prospective (pre/post) study. The calculated sample size needed is 120~     subjects, 60 in each group.~   "
44242|NCT02987699|"~     The purpose of this phase II study is to determine the recommended dose, as well as the~     safety and efficacy of the combination of oxaliplatin, leucovorin and 5-Fu introduced by~     hepatic arterial infusion chemotherapy (HAIC) in patients with advanced hepatocellular~     carcinoma (HCC).~   "
44243|NCT02987686|"~     Corneal melt is a complication that could affect very ill eyes and lead to the thinning of~     the cornea (the clear window covering of the eyes). This thinning can lead to severe~     consequences such as the leakage of the liquid inside the eye (ocular perforation), or even~     blindness. Corneal melt can be caused by certain infections or as a sterile process. This~     project only includes patients with a sterile corneal melt (without an infection) caused by~     diseases such as rosacea, Sjogren's syndrome, rheumatoid arthritis, Crohn's disease, Stevens~     Johnson syndrome, as well as toxic epidermal necrolysis or mucous membrane pemphigoid.~      Infliximab is an antibody against tumour necrosis factor alpha and has been used to treat or~     prevent corneal melt in certain patients with inflammatory of auto-immune disease. In this~     situation, infliximab was used intravenous (using veins) in order to treat the whole body.~      This study's hypothesis is that infliximab can safely be used as eye drops for the treatment~     of sterile corneal melt.~   "
44244|NCT02987673|"~     Background While several articles have reported about the effects of laparoscopic sleeve~     gastrectomy (LSG) on the lower esophageal sphincter (LES), to date, just one paper has~     discussed this issue with regard the Mini/One anastomosis gastric bypass (MGB/OAGB). This is~     expected to be the first randomized trial exploring and comparing these two interventions.~      Setting Federico II University Hospital, Naples - ITALY.~      Methods Fifty morbid obese patients are going to be studied. All patients presenting with a~     normal preoperative LES function will be randomly assigned to undergo LSG (arm 1 - 25 pts) or~     MGB (arm 2 - 25 pts). Patients undergo clinical assessment for reflux symptoms, and~     esophago-gastro-duodenoscopy (EGDS) plus high-resolution impedance manometry (HRiM) and~     24-hour pH-impedance monitoring (MII-pH) before, two months and 1 year after both LSG or~     MGB/OAGB.~      Objective Endpoint 1: Does this surgery affect the LES area function in both arm 1 or arm 2~     patients determining a possible increase in gastroesophageal acid or non acid reflux?~     Endpoint 2: Does one between the two procedures outperform the other one in terms of eventual~     LES area modifications? Endpoint 3: In the case of a good performance of LSG or MGB/OAGB or~     both the procedures, is this to be primarily related to surgery per se or to weight loss?~   "
44245|NCT02987660|"~     The purpose of this study is to compare Topography Guided Laser In Situ Keratomileusis~     (LASIK) corneal surgery to Small Incision Lenticule Extraction (SMILE) corneal surgery for~     the treatment of myopia with astigmatism.~   "
44246|NCT02987647|"~     To evaluate the perception of the effectiveness of Hidrafemme® gels, Vagidrat®, Lubrinat and~     Antrofi cream in improving vaginal moisture in postmenopausal women who are currently~     registered options most current and available in the market in order to assess the~     differences between them, subsequently conduct a clinical study larger.~   "
44247|NCT02987634|"~     Izun Pharmaceuticals has shown that PeriActive, an oral rinse containing extracts of Sambucus~     nigra, Echinacea purpurea, and Centella asiatica significantly reduced gingival inflammation~     in an experimental gingivitis model in a phase II study, as well as in numerous other~     clinical trials. The product and its individual components were shown to be safe.~      Based on these favorable results, Izun is now seeking to demonstrate that a combined~     anti-bacterial/anti-inflammatory rinse will potentially enhance soft tissue healing and~     reduce localized inflammation following dental implant surgery equal to, or better than, a~     chlorhexidine rinse, with fewer side effects.~   "
44248|NCT02987621|"~     In this project the investigators will be using non-invasive brain stimulation on people with~     multiple sclerosis (PwMS) to improve leg muscle function. Two groups of participants will be~     recruited. One group will perform strength testing with and without the brain stimulation.~     After completing the strength testing the participants will walk for six minutes to see if~     any increases in strength translate into improve mobility. The second group of participants~     will perform a fatigue task, pulling against a wire at a low level of force, with and without~     the brain stimulation. This type of brain stimulation has been shown to transiently improve~     strength and fatigue measures in other populations, e.g. aged, Parkinson's, and improve~     cognitive abilities in people with multiple sclerosis. It is the investigator's hope that the~     increases in performance seen in other patient groups will also occur in people with multiple~     sclerosis. Future investigations will look to apply the non-invasive brain stimulation~     technique during physical rehabilitation to improve short and long term outcomes related to~     physical function.~   "
44249|NCT02987608|"~     There is an increasing demand for digital tools to empower young people with mental health~     difficulties (NHS England, 2015). Digital information, advice and mood tracking tools are~     increasingly being used to support child mental health. Evidence suggests that young people~     want to be active participants in their care and involved in decisions about their treatment.~     However, there is a lack of digital shared decision making tools available to support young~     people in Child and Adolescent Mental Health Services (CAMHS). This study aims to develop~     Power Up, a smartphone app to empower young people in CAMHS to make their voice heard and to~     participate more in decisions around their care.~      The project will involve two phases:~        -  Development Phase -Developing Power Up according to the views and ideas expressed by~          young people, their parents/ carers, and clinicians in Patient and Public Involvement~          (PPI) sessions. -Conducting interviews and focus groups with 10 young people in CAMHS,~          10 parents/ carers and 10 clinicians to review the acceptability of the content and~          format of Power Up.~        -  Feasibility testing Phase -Conducting a feasibility trial with 120 young people with~          emotional difficulties, aged 11-19 years, from three London CAMHS. 60 young people will~          receive treatment as usual and 60 will use Power Up alongside treatment as usual.~          Participant's ratings of empowerment, activation, and symptoms will be measured soon~          after their referral to the service. The same measures plus shared decision making~          questionnaires will be administered three months later.~      The findings will inform the planning of a prospective cluster controlled trial. More broadly~     this trial will contribute an understanding of the feasibility and acceptability of~     developing and implementing a shared decision making app into CAMHS.~   "
44250|NCT02987595|"~     Diet plays an important role in relation to prevention of type 2 diabetes, cardiovascular~     disease and certain cancers. Studies have shown that diets with high whole-grain content~     could decrease the risk of these lifestyle related diseases and in Sweden the national~     dietary guidelines recommends whole-grain based instead of refined cereal products. It is,~     however, not clear whether whole-grain from wheat and rye share similar protective effects~     since there are large differences in amount and quality of dietary fibre and associated~     bioactive compounds. The aim of this study is to evaluate the impact of a wholegrain diet~     with low- or high lignan content on different cardiometabolic risk factors with the primary~     endpoint being blood glucose levels after 2h oral glucose tolerance test in men with~     metabolic syndrome or sign thereof.~   "
44539|NCT02983825|"~     Continuous positive airway pressure (CPAP) is used in premature infants to maintain lungs~     open and facilitate gas exchange. When ventilation/perfusion (V/Q) mismatch is present, areas~     of the lung that are open for gas exchange do not match up with the areas of the lung that~     are receiving blood for gas exchange. This study measure the responsiveness of V/Q mismatch~     to changes in the amount (or level) of CPAP.~   "
44251|NCT02987582|"~     Living with symptoms of mental illness is associated with psychosocial impairment as it can~     affect someone's ability to work, their relationships and level of functioning. This also has~     high economic costs on a societal level. It has been shown that an increase in~     self-compassion may result in a secondary benefit of reducing psychological distress, which~     could offer substantial benefits. There is little empirical data on Emotion Focused~     Mindfulness (EFM) interventions for the population we are studying. This study aims to~     address this gap in the literature and practice, thus advancing the field.~   "
44252|NCT02987569|"~     12 month study testing mobile delivery of health information and connections to professionals~     and peers to improve health of teen/young adult HPN users.~   "
44253|NCT02987556|"~     The study will be conducted in crossover trial, with two 12-weeks periods separated by a~     Wash-out period of at least one month. According to randomization ,patients will be provided~     with either Diabeloop system or the usual system.~      Patients will be trained for the use of blood glucose meter, of external Insulin Pump and~     Diabeloop system.~      In both treatment periods, the same blood glucose meter will be used throughout the duration~     of the study.~      In two centers (Centre Hospitalier Sud-Francilien and Grenoble), a pre-study will be~     performed during four weeks to improve the efficacy of Diabeloop system with data collection,~     to test the manual settings by health care providers and patients and to check the~     good-working of the follow-up platform.~   "
44254|NCT02987543|"~     The purpose of this study is to evaluate the efficacy and safety of olaparib versus~     enzalutamide or abiraterone acetate in subjects with metastatic castration-resistant prostate~     cancer who have failed prior treatment with a new hormonal agent and have homologous~     recombination repair gene mutations.~   "
44255|NCT02987530|"~     The purpose of this study is to compare the impact of two combination of two tablets once~     daily: dolutegravir associated with emtricitabine / tenofovir versus darunavir / cobicistat~     associated with emtricitabine / tenofovir on DNA HIV measured in PBMC at 48 weeks in patients~     with primary HIV-1 infection.~   "
44256|NCT02987517|"~     This study will use a comparative effectiveness design of two interventions known to reduce~     running impacts. The study will be conducted at the Spaulding National Running Center. A~     total of 40 male and female participants, between ages 18-50 years, running 10- 30 miles per~     week will be recruited from the local running community. All potential subjects will be~     cleared for physical activity using a Physical Activity Readiness Questionnaire (PAR-Q) and~     screened via high-speed video to determine their habitual footstrike pattern. Those who are~     rearfoot strikers will be included and will then be randomized to either an increased cadence~     (CAD) or a forefoot strike (FFS) intervention group. Standardized running shoes will be~     provided to both groups for the duration of the study. All participants will attend 2~     strength-training instruction sessions with a physical therapist prior to gait-retraining~     intervention. They will be instructed to perform the learned exercises daily for 4 weeks to~     prepare the body tissues for forces associated with new gait methods. Subjects will then~     attend 8 gait-retraining sessions over 2-3 weeks. Sessions will be scheduled as two~     sequential days of training followed by a day of rest. The gait retraining protocols will be~     conducted on a treadmill. 3D Motion Capture analysis will be conducted at baseline and at 3~     points following intervention (1 week, 1 month, and 6 months).~   "
44257|NCT02987504|"~     This is a multicenter, open-label, dose-escalation, Phase 1 study of intravenous (IV)~     samalizumab to determine its maximum tolerated dose (MTD), overall safety/tolerability,~     PK/pharmacodynamic parameters, and efficacy in patients with advanced solid tumors.~   "
44258|NCT02987491|"~     Obesity is associated with a decrease in skeletal muscle insulin sensitivity. Aerobic~     exercise can increase insulin sensitivity in the few hours following exercise, however the~     cellular mechanisms are not completely understood. The current project is to investigate~     mechanisms of exercise improvements to skeletal muscle insulin sensitivity.~   "
44259|NCT02987478|"~     All patients will undergo in vitro fertilization.~      Serum 25 (OH) D samples will be collected within1 week before oocyte retrieval.~      Whole blood specimens will be collected in serum separator tubes using acceptable medical~     techniques to avoid hemolysis.~      Ultrasound guided fresh embryo transfer will be performed on day 5 after fertilization.~      clinical pregnancy will be confirmed by observation of intrauterine sac visible on ultrasound~     performed 4-5 weeks after embryo transfer.~   "
44260|NCT02987465|"~     In people diagnosed with chronic kidney disease (CKD) anaemia is a common problem and is~     often treated with EPO (Erythropoietin). One form of EPO used is Darbepoetin (Aranesp®). EPO~     is safe to use but it has been associated with a rise in blood pressure (BP) in some~     individuals. The reasons for this are not clear. To try to explain this, this study will look~     at how EPO affects certain substances in the blood that influence how blood vessels contract~     and relax. This will be conducted by infusing small amounts of Acetylcholine, BQ123 and~     Noradrenaline into the arm vessels of volunteers using an established method called Forearm~     blood flow (plethysmography). Volunteers recruited for this study will include CKD patients~     undergoing therapy with Darbepoetin as part of their normal NHS care as well as healthy~     people not on treatment, who will act as controls. This is an observational pilot study of~     changes in physiology before and after Darbepoetin. It will provide valuable data for a later~     study comparing Darbepoetin to novel agents which work via different pathways to treat~     anaemia.~   "
44261|NCT02987452|"~     Lifestyle changes might reduce cardiovascular risk due to the decrease in blood pressure~     (BP). However, whether combining aerobic and resistance exercises affect BP and hemodynamic~     parameters, as well as arterial stiffness and inflammation markers in resistant hypertensive~     (RHTN) patients, have not been investigated yet.~   "
44262|NCT02987439|"~     Purpose: In a randomized controlled trial we will assess the effect of early pulmonary~     rehabilitation in patient with an acute exacerbation of chronic obstructive lung disease~     (AECOPD).~   "
44263|NCT02987426|"~     Mindfulness-based interventions have gained increasing popularity in recent years as~     effective treatment for mental illness. Mindfulness is defined as paying attention in a~     particular way: on purpose, in the present moment, and non-judgmentally: Being, rather than~     Doing. Such mental states can improve emotional regulation through frontal cortex~     inhibition of otherwise dysregulated subcortical emotion-related circuits. Formal mindfulness~     approaches such as mindfulness-based cognitive therapy (MBCT) and mindfulness-based stress~     reduction, have been highly effective in a broad range of psychiatric disorders.~      Mindfulness-oriented interventions, are potentially useful in acute psychiatric~     hospitalizations, since they can be delivered as group therapies and are be both~     cost-effective and scalable. However, such interventions have rarely been provided to~     patients during psychiatric hospitalizations, where patients are treated for a variety of~     psychiatric diagnoses, and may have unpredictable lengths of stay. Additionally, there had~     been concerns that longer traditional mindfulness based interventions (e.g. 30 minute silent~     meditation) may exacerbate acute psychosis. However, strong evidence suggests that patients~     with psychotic symptoms appear to be largely unaffected by shorter interventions. Similarly,~     MBCT have been helpful to treat other major reasons for hospitalization such as: bipolar~     disorder, severe anxiety, substance use disorders, and major depressive disorder.~      Few studies have examined mindfulness-oriented treatments in inpatient settings, including~     two small studies involving mindfulness groups on an acute psychiatric inpatient ward (n<10)~     . Another study (n=23) offered inpatients with a diagnosis of major depressive disorder~     mindfulness-based activities. All studies concluded that mindfulness-oriented approaches in~     inpatient settings were feasible, although these needed to be brief interventions, given the~     risks and lack of efficacy of longer MBI (e.g. 40-minute silent meditation) in severe mental~     illness.~      A cross-sectional study conducted by our team (n=40) demonstrated that brief group~     mindfulness-oriented lasting 10 minutes were very well tolerated by 92.5% of psychiatric~     inpatients. The remaining 7.5% of patients left the session before 10-minutes, but had no~     symptomatic exacerbations or adverse effects. Moreover, the 50% of patients self- reported~     improvements in general well-being and mood after a single 10-minute session. Having been~     recently admitted to the psychiatric inpatient or having a diagnosis of acute psychosis (75%~     of inpatients) did not affect patients' capacity to tolerate and benefit from the~     intervention. In this inpatient psychiatric population, we found that mindfulness-oriented~     interventions that were brief and involved physical movement (e.g. seated Tai Chi) were~     better enjoyed compared to other interventions.~      Despite the growing literature in this field, data is needed on the effectiveness and health~     service implications of brief group mindfulness-oriented interventions in inpatient~     psychiatry settings. Outcome studies conducted so far cannot be interpreted reliably due to~     methodological flaws, including inadequate control groups, very small sample sizes (often~     n<10), and lack of randomization. In Canada, the direct cost of treatment for mental illness~     is estimated as 42.3 billion. Much of these costs are driven by psychiatric admissions. Thus,~     if brief mindfulness-oriented interventions are effective at lowering psychiatric symptom~     severity and shortening psychiatric hospitalizations, this could lead to significant~     cost-savings.~   "
44317|NCT02986711|"~     This study aims to pilot a method of collecting the post-discharge follow-up data required by~     the Joint Commission Tobacco Measure Set, using text messages sent to and received from~     patients' cellular-telephones. It also aims to assess whether specially designed relapse~     prevention text messages designed to encourage abstinence from smoking, can increase the~     proportion of smokers who remain abstinent during the first month after discharge from~     hospital.~   "
44264|NCT02987413|"~     Background: Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease that~     selectively affects motor neurons in the brain and spinal cord, leading to bulbar,~     respiratory, and limb weakness. There is no effective treatment, and the disease usually~     progresses to death within 2 to 4 years. The therapeutic plasticity of mesenchymal stem cells~     (MSCs) may be an attractive therapy to this complex disease, turning MSCs strong candidates~     for cellular therapy in ALS.~      Design—A phase 1 open-safety clinical trial. 4 patients will be selected according to a~     restricted inclusion and exclusion criteria and after 2 escalated infusions of MSCs, there~     will be a follow up period of one year Methods - Primary endpoint: safety of mesenchymal~     autologous stem cells infusions escalated in two intrathecal administrations in patients with~     ALS defined as severe adverse events (SAe). Secondary endpoints: clinical response,~     laboratorial and magnetic resonance imaging of patients submitted to cellular escalating~     doses applied in the study. Quality of life, according to El Escorial criteria, ALSFR scale~     and functional scales.~      Conclusion: This study is a primary step before a large randomized double-blind clinical~     trial for ALS. It is expected to confirm the safety of escalated MSCs therapy in ALS~     patients, initial data of efficacy in addition to improved quality of life.~   "
44265|NCT02987400|"~     The purpose of this study is to evaluate the clinical activity and tolerability of a~     combination of obinutuzumab plus venetoclax in patients with relapsed or refractory diffuse~     large B-cell lymphoma.~   "
44266|NCT02987387|"~     This study will confirm the safety and effectiveness of the Edwards Lifesciences SAPIEN XT~     Transcatheter Heart Valve (THV) System in patients with a dysfunctional right ventricular~     outflow tract (RVOT) conduit with a clinical indication for intervention in a post-market~     setting.~   "
44267|NCT02987374|"~     The purpose is to investigate B-cell response to the trivalent Influenza Vaccine (TIV) in~     healthy young adults by vaccinating participants and obtaining blood samples at designated~     time points before and after vaccination.~   "
44268|NCT02987361|"~     The investigators hypothesize that transcranial direct current stimulation (tDCS) can improve~     upper limb motor recovery in the sub-acute phase of stroke patients.~      This is a randomized, controlled, double blind, cross-over, multicentre, clinical trial.~   "
44269|NCT02987348|"~     This is a retrospective cohort study based on Clinical Practice Research Datalink (CPRD)~     database analysis to compare therapy effectiveness, and cost between exenatide and basal~     insulin in patients with type 2 diabetes.~      Type 2 diabetes (T2DM) is a chronic condition characterized by elevated blood sugar levels~     (hyperglycaemia) that can result in an increased risk of a variety of conditions including~     heart disease, strokes, kidney failure, blindness and amputation. Whilst initially patients~     may control their blood sugar by lifestyle modification (diet and exercise), ultimately most~     will require therapeutic intervention with regimens that increase in complexity as T2DM~     progresses. Exenatide is a relatively recent anti-diabetic drug which is known to lead to~     weight loss as well as improved blood glucose control. It has also been associated with~     reduced heart attacks and strokes. In this study CPRD database will be used to compare~     outcomes for patients prescribed exenatide compared with those prescribed insulin; a more~     established treatment for T2DM. In particular changes from baseline in blood sugar control~     and weight will be considered as the primary outcomes. As the choice to treat with exenatide~     or insulin will be related to patient characteristics which may in themselves be associated~     with the outcomes of the study we aim to match study patients on some of these key variables~     and adjust for others in our analysis.~   "
44270|NCT02987335|"~     India has the world's highest prevalence of diabetes, expected to rise to 80 million by 2030.~     This includes many patients with lean diabetes, with low body mass index (BMI) and severe~     complications of diabetes. Despite its prevalence in India and other countries and its dire~     health consequences to individuals with the disease, little is known about the~     aetiopathogenesis and the genotype-phenotype relationship, lean diabetes being a cluster of~     low birth weight individuals, MODY, lipododystrophic disease, type 1 diabetes and~     fibrocalcific disease. While rudimentary tests have suggested defects in both insulin~     secretion and action, no comprehensive metabolic studies have been performed. It is therefore~     unclear as to how these patients should be treated. The optimal therapeutic adjunct whether a~     suitable oralantidiabetic agent or insulin is not yet determined. Defining the metabolic~     defects of 'lean' diabetes should have tremendous therapeutic benefit for millions of~     patients with this elusive condition.~   "
44271|NCT02987322|"~     Background: Honey, as a natural product produced by honey bees, has anti-oxidant,~     anti-microbial, anti-inflammatory and immunomodulator properties. A few reports suggest that~     honey might have positive effects on cardiovascular diseases.~      Methods: This was a randomized controlled study, which was carried out on 50 children, aged 2~     to 12 years, suffering from idiopathic dilated cardiomyopathy (IDC). Patients were randomly~     assigned into two equal groups: the honey group and the control group. In the honey group,~     honey was provided in a dose of 1.2g/kg/day for three months in addition to the traditional~     treatment of IDC. The patients in the control group received only their standard treatment,~     without honey. The main outcome measure was the percent change in the ejection fraction (EF)~     and the fraction shortening (FS) shown in echocardiography.~   "
44272|NCT02987309|"~     Dosing of nutrition in PICUs is mainly based on patient weight and assumptions on clinical~     status. There is however poor correlation between these calculations and actual energy~     consumption measured with indirect calorimetry (IC). Available equipment for IC has however~     been too cumbersome to use in daily clinical practice. Of relative new date is IC integrated~     in modern ventilators. This functionality is easy to use, but we do not know if the results~     are reliable for children. This study is a method comparison study comparing measurements~     done with SensorMedics Vmax (gold standard) vs GE Carescape (modern ventilator with~     Integrated IC) in children undergoing intensive care treatment.~   "
44318|NCT02986698|"~     The investigators aims to evaluate the safety of in utero hematopoietic stem cell~     transplantation in fetuses with alpha-thalassemia major performed at the time of in utero~     transfusion of red blood cells.~   "
44369|NCT02986035|"~     This pilot trail aims to assess the effectiveness of ECA cream in the treatment of calcifying~     shoulder tendinitis in terms of:~        1. Reduction or removal of shoulder calcifications~        2. Functional improvements~        3. Pain improvements 10 subjects will be assessed prior and 1 and 2 months post~          intervention onset. The intervention will consist in the application of the ECA cream in~          the affected shoulder twice a day during 1 month.~   "
44273|NCT02987296|"~     The immune system plays an important role in helping to kill and prevent cancers. Cells of~     the immune system, such as natural killer (NK) cells and T cells, do not work as well~     following surgery. Arginine, an amino acid, is fundamental in metabolic processes of the~     body. Surgery has shown to cause a reduction of arginine in the body. In turn, this~     deficiency causes NK cell suppression. In this study, we want to look at the effects of~     arginine supplementation before and after surgery on NK cell function in surgery patients. In~     this study, we will be using a nutritional supplement containing arginine and a placebo drink~     (provided by Enhanced Medical Nutrition) that will be taken by colorectal cancer patients 5~     days before surgery and 5 days after surgery. Using patient blood samples, we will measure NK~     cell levels, arginine levels and also arginase activity.~   "
44274|NCT02987283|"~     The investigators will perform a diagnostic accuracy study comparing tracheal breath sound~     recordings in awake individuals to the STOP-Bang screening questionnaire, using the~     apnea-hypopnea index (AHI) score determined by polysomnography as the gold standard.~   "
44275|NCT02987270|"~     This study is a cluster-randomized controlled trial to evaluate the efficacy of~     community-based mass screening with a malaria rapid diagnostic test, and treatment of~     participants with positive tests with an appropriate antimalarial for reducing malaria~     transmission indices.~   "
44276|NCT02987257|"~     Defining the true effect of adjunctive therapy for Stevens-Johnson Syndrome and Toxic~     Epidermal Necrolysis (SJS/TEN) on time to full healing, mortality, and long-term outcomes~     represents a critical need in the field of dermatology and burn surgery. Collaborating with~     20 sites from across North America we will determine if cyclosporine or etanercept therapy~     improves SJS/TEN short outcomes above supportive care alone The scientific premise for this~     study is that case series, cohorts, and small non-randomized studies have not supported the~     use of non-pulsed corticosteroids and intravenous immunoglobulin (IVIG), while showing the~     promise of cyclosporine and etanercept in reducing the time to complete re-epithelialization.~     By indirect comparison, etanercept appears to be superior in small studies, however none of~     the studies have evaluated these therapies in a blinded and randomized trial. Additionally,~     we will uncover the underlying process of SJS/TEN through the analysis of skin samples,~     blood, blister fluid and immune cells to study the immune system and changes in gene~     expression with and without drug therapy. This will improve the treatment of patients in the~     future.~   "
44277|NCT02987244|"~     The purpose of this study is to determine determine the maximum tolerated dose (MTD) and~     safety of the combination of Chidamide combined with CHOEP(cyclophosphamide，~     epirubicin,vindesine, etoposide and prednisone) regimen as first line treatment in~     newly-diagnosed T-NHL.~   "
44278|NCT02987231|"~     The objective of this study is to evaluate clinically and through the concentration of~     inflammatory markers, the results of 6 months of electrical stimulation associated with~     coronally advanced flap for treatment of gingival recession.~   "
44279|NCT02987218|"~     Aneurysmal subarachnoid hemorrhage (aSAH) is characterized by the rupture of an intracranial~     aneurysm and accumulation of blood in the subarachnoid space with 30 to 40% mortality rate.~     Amongst the survivors 40-50% suffers disability due to cognitive decline.Trends towards early~     surgery offers challenge to anesthesiologist to provide optimum brain relaxation and~     simultaneously maintaining stable hemodynamics. Anesthetic agents are administered to conduct~     smooth neurosurgical procedure. These agents may affect patient's cognitive function~     postoperatively.Currently most common anesthetic agents used are either intravenous hypnotic~     agents (propofol) or volatile inhalational agents (isoflurane/sevoflurane/desflurane).~     Provision of neuroprotection with propofol and volatile inhalational agents has been studied~     by various authors.Not many studies have been performed in patients undergoing aneurysmal~     clipping surgeries looking into effects of various anesthetic agents on intraoperative (I/O)~     brain condition, I/O hemodynamic and POCD.Thus present study is planned to compare propofol~     and desflurane for long term postoperative cognitive decline in patients undergoing surgery~     following aneurysmal subarachnoid hemorrhage.~   "
44280|NCT02987205|"~     A randomized, multicenter, double blind, split-face study in subjects seeking NLF correction.~     Subjects were treated with Revanesse Ultra in the NLF on one side of the face and Restylane~     in the NLF on the other side of the face. The side of the face for each product was randomly~     assigned. The investigator performing the evaluations and the subject were blinded to the~     treatment; injections of the study product were performed by an unblinded injecting~     investigator.~   "
44281|NCT02987192|"~     Spinal canal anesthesia is marked the most commonly used method of cesarean section.~     Traditional spinal anesthesia may cause post-dural puncture headache and low back pain.Plenty~     of parturients are undergoing anticoagulation therapy.They may be forced to accept general~     anesthesia in order to avoid epidural hematoma.Therefore, we propose minimally invasive~     spinal anesthesia.~   "
44282|NCT02987179|"~     The clinical diagnosis of sleep apnea is difficult among ESRD patients since the~     characteristic clinical features of sleep apnea may be absent and since sleep-related~     symptoms, such as fatigue and sleepiness, may be attributed to kidney failure. However, the~     evaluation of patients with possible sleep apnea is the same among ESRD patients as in the~     general population.~   "
44283|NCT02987166|"~     This study is a pilot study to evaluate high-dose conformal radiation therapy (HDCRT)~     administered in combination with pembrolizumab in patients with solid tumors.~   "
44284|NCT02987153|"~     Kypho-IORT is a novel approach to combine kyphoplasty, a minimally invasive procedure, with a~     single dose of intraoperative radiotherapy (IORT) for the treatment of unstable or~     potentially unstable spinal cord metastases. The primary objective is to evaluate the~     response rate of pain control when combining kyphoplasty, a minimally invasive procedure,~     with a single dose of intraoperative radio- therapy (IORT) for the treatment of spinal cord~     metastases. Secondary objectives are (i.) to determine feasibility for unstable or potential~     unstable spine metastases; (ii.) to determine tolerability/side effects of the IORT within 90~     days post-procedure; (iii.) to determine which clinical factors are prognostic of vertebral~     compression fracture~   "
44285|NCT02987140|"~     The overall goals of this proposed study are to investigate the behavioral and~     neurophysiological mechanisms of patients with Parkinson's disease (PD) experiencing freezing~     of gait (FoG). More specifically, we aim to determine the behavioral changes in~     context-dependency and changes in corticomotor excitability associated with FoG.~   "
44286|NCT02987127|"~     Gastric low-grade mucosa-associated lymphoid tissue lymphoma (MALToma) is associated with~     Helicobacter pylori (HP) infection, and around 70% of these tumors can be cured by HP~     eradication therapy (HPE). However, the role of antibiotics in the frontline treatment of~     extragastric MALToma remains unclear. In addition to anecdotal case reports showing~     histologic regression of extragastric MALTomas after antibiotics, our explorative study found~     that frontline HPE (clarithromycin, amoxicillin, and omeprazole) resulted in complete~     remission (CR) in this subgroup patients (2 salivary gland, 1 lung, 1 colon, and 4 ocular~     adnexal MALToma [OAML]). Interestingly, two patients with OAML who do not respond to~     Chlamydia psittaci (CP) eradication using doxycycline achieved CR after HPE. These findings~     suggest that bacterial infections, including HP, may be involved in the lymphomagenesis of~     these extragastric MALTomas. Our preliminary results also revealed that 5 (23.8%) of 21~     HP-negative gastric MALToma patients achieved CR after HPE, indicating that antibiotics may~     also have ability to eradicate non-HP bacteria. Based on our preliminary findings and the~     indolent biologic behavior of MALToma, it is reasonable to use frontline HPE in the treatment~     of early-stage low-grade extragastric MALToma.~   "
44287|NCT02987114|"~     To evaluate the safety, tolerability and efficacy of oral administration of PTL101~     (cannabidiol) for the treatment for pediatric intractable epilepsy.~      Study will include a 4-week observation period ,12 weeks of treatment and 2 weeks of follow~     up.~   "
44288|NCT02987101|"~     Chronic leg ulcers are associated with decreased quality of life and an increased mortality.~     In many cases these ulcers are treated conservatively and the healing time can be several~     months. In this open randomized clinical trial we will examine if we can accelerate wound~     healing when using autologous stromal vascular fraction as an adjunct to standard wound care.~   "
44289|NCT02987088|"~     The purpose of this study is to determine the optimal dose of sodium nitrate administered~     during resuscitation to achieve a plasma level of 10 μM by hospital arrival.~      Pharmacokinetic modeling from human cardiac arrest studies suggest that a single 25 mg IV~     dose of sodium nitrite will achieve the optimal (based on preclinical studies)~     neuroprotective plasma levels of 10 μM. In this phase-1 open-label dose finding study in 100~     patients, we will determine whether 25 mg IV administered during resuscitation will achieve~     plasma nitrite levels of at least 10 μM by hospital arrival. Dose adjustments, either~     decreasing or increasing, will be made if necessary permitting us to determine the optimal~     nitrite dose needed to achieve the 10 μM plasma target. Safety data will also be collected~   "
44290|NCT02987075|"~     A comparison of ongoing pregnancy rate between cleavage stage and early compacting embryo~     transfer at 66±2 hours after ICSI using single step culture medium~   "
44291|NCT02987062|"~     According to current guidelines for non-valvular atrial fibrillation treatment, the first~     line drugs are non-vitamin K oral anticoagulants (NOACs), which are preferred over vitamin K~     antagonists (VKAs). However, it is not clearly confirmed, how the success of NOACs approval~     trials (ROCKET-AF (rivaroxaban), RE-LY (dabigatran) and ARISTOTLE (apixaban) reflects on~     real-life clinical practice.~      The aim of this study is to assess treatment of AF patients with oral anticoagulants (OACs)~     in an academic and district hospital, with regard to inclusion/exclusion criteria used in the~     clinical trials.~   "
44292|NCT02987049|"~     The purpose of this study is to fill in the gaps in knowledge on the tolerability and~     effectiveness of an outpatient, Pritikin-based Intensive Cardiac Rehabilitation (ICR) program~     on traditional cardiovascular risk factors, exercise performance, and patient well-being (as~     assessed by questionnaires), as well as to monitor subsequent clinical events. The hypothesis~     is that patients in the Intensive Cardiac Rehabilitation (ICR) group will have greater~     improvements in several cardiovascular disease risk factors than patients in the conventional~     Cardiac Rehabilitation (CR) group at the end of 24 sessions.~   "
44293|NCT02987036|"~     The purpose of this study is to find out weather differences in administration nebulizer~     technology (Jet nebulizer VS. mesh nebulizer) will have impact on lung mechanic variables~     (Compliance, resistance and PEEPi) during controlled mechanical ventilation.~   "
44294|NCT02987023|"~     The study is a follow up of NCT01844362. Uterus transplantation will be performed from live~     donors to patients with uterine factor infertility. If will be performed before~     transplantation. Organ procurement from the donor will be performed by robotic assisted~     laparoscopy. Transplantation will be by laparotomy. Embryo transfer will be done 10-12 months~     after transplantation. After birth of 1-3 children the uterus will be removed by~     hysterectomy,~   "
44295|NCT02987010|"~     Cohort A - neoadjuvant administration of IDH305 at 550 mg BID for 6 weeks followed by~     surgical resection at 6 weeks. If there is no evidence of progressive disease at 6 weeks~     (clinical, radiographic or histopathologic exam), the patient will continue on IDH305 at 550~     mg BID post-operatively for a maximum of 11 additional 28 day cycles. Subsequent assessment~     of disease will occur every 2 months starting in Cycle 2.~      Cohort B - patients who have inoperable tumors but measurable 2HG pre-treatment will be~     treated with IDH305 at 550 mg BID x 6 weeks. If there is adequate sustained knockdown of 2HG~     on MRS and disease is stable or improved, then the patient will continue on treatment for a~     maximum of 11 additional 28 day cycles.~   "
44296|NCT02986997|"~     Percutaneous nephrolithotomy (PNL) is a renal lithiasis treatment. It is usually two staged:~     it begins in the lithotomy position for ureteral catheter placement and retrograde~     pyelography and, subsequently, an optimal renal access is obtained in the prone position. In~     most of the centers, the PNL is done under general anesthesia (GA) that is associated with a~     risk of complications due to putting an intubated, muscle-relaxed, unconscious patient in a~     prone position. In our Department the procedure is usually performed under epidural~     anesthesia. The aim of this study was to evaluate the epidural anesthesia performed for PNL~     over the last decade in the Medical University of Warsaw Urology Department~   "
44343|NCT02986373|"~     This is an open-label extension (OLE) study to assess the efficacy, safety and tolerability~     of risankizumab in subjects with psoriatic arthritis (PsA) who have completed all doses of~     study drug and the Week 24 visit of Study 1311.5 (Phase 2 randomized control trial in PsA~     subjects, sponsored by Boehringer Ingelheim).~   "
44391|NCT02985749|"~     This study is an 8-week pilot trial with oxytocin nasal spray (Syntocinon) as a treatment for~     social impairment in children and adults with high functioning autism spectrum disorders~     (ASD). The investigators hypothesize that oxytocin will be safe, tolerable, and effective in~     improving social deficits in individuals with ASD.~   "
44297|NCT02986984|"~     This is a prospective, observational, cohort study of patients with a clinical diagnosis of~     diabetes who are undergoing clinically indicated kidney biopsy. The intent is to collect,~     process, and study kidney tissue and to harvest blood, urine and genetic materials to~     elucidate molecular pathways and link them to biomarkers that characterize those patients~     have a rapid decline in kidney function (> 5 mL/min/1.73m2/year) from those with lesser~     degrees of kidney function change over the period of observation. High through-put genomic~     analysis associated with genetic and biomarker testing will serve to identify key potential~     therapeutic targets for DKD by comparing patients with rapid and slow progression patterns.~     Each participating clinical site will search for, consent, harvest the biopsy sample, and~     enroll the participants as required for the TRIDENT protocol.~   "
44298|NCT02986971|"~     There are no implant removal devices on the market by any manufacturer. New features are~     described in comparison with the existing removal technique. Overall, the RemovAid™ combines~     the features of fixation, incision and extraction. This combination of functions has not~     previously been combined in a single device.~      The investigators wish to perform this pilot clinical investigation with the aim to~     demonstrate that the Investigational Medical Device (IMD), RemovAid ™, may safely and~     effectively facilitate implant removal. Other aims are to show that the IMD have the~     potential to reduce procedure length variability, reduce procedural complexity and reduce the~     need for additional procedural equipment related to CI removal procedures, without causing~     any harm to the subject.~   "
44299|NCT02986958|"~     This study evaluates an agenda-setting checklist for patients with cognitive impairment and~     their family companions that is completed in the waiting room in advance of a primary care~     visit. The study team will conduct a two-group randomized trial to examine feasibility of the~     protocol and to compare medical communication (from visit audiotapes) during visits of~     patient-companion dyads who complete the checklist (n=50) with patient-companion dyads who~     receive usual care (n=50)~   "
44300|NCT02986945|"~     The purpose of the study is to test an experimental method, a text-messaging app called~     B-RESILIENT, for improving participants' mood. B-RESILIENT is a text messaging app adaptation~     of a Resiliency Course, developed by community members known as Building Resiliency and~     Community Hope.~   "
44301|NCT02986932|"~     This is a prospective, non-randomized, single-arm, feasibility study to evaluate the safety~     and initial effectiveness of opening of the Blood-Brain Barrier with intravenous contrast~     agents using the ExAblate Neuro System in patients with early stage Alzheimer's Disease.~   "
44302|NCT02986919|"~     Establish safety and toxicity profile and preliminary response rate of CPI-0610 in MPNST~     patients and correlate response with pharmacodynamics markers and BET inhibition.~   "
44303|NCT02986906|"~     Ulnar neuropathy at elbow (UNE) is the second common peripheral entrapment neuropathy.~     Although many conservative managements of UNE, the effectiveness of these methods are~     unsatisfied especial the moderate degree of UNE. Recently, ultrasound-guided perineural~     injection therapy (PIT) with 5% dextrose is progressively applicated for clinical treatment~     for entrapment neuropathy. However, current studies have not proved the effects of PIT on~     peripheral neuropathy because these studies enrolled small number of patients and lacked~     controlled design. We design a randomized, double-blind, controlled trail to assess the~     effect after ultrasound-guided PIT with 5% dextrose in patients with mild and moderate UNE.~   "
44304|NCT02986893|"~     The goal of this project is to establish the feasibility of dietary research in Multiple~     Sclerosis (MS) patients as well as to provide preliminary data to support future clinical~     trials of diet in MS. This project is a pilot randomized trial of a dietary intervention in~     MS patients. The dietary intervention was designed to include dietary components that have~     been suggested to be of benefit in MS through basic science research and observational-type~     studies in MS patients and to exclude those that have been suggested to be detrimental. It is~     therefore rich in foods that are high in polyunsaturated fatty acids (particularly omega-3~     fatty acids), foods that are high in polyphenols and antioxidant vitamins such as berries and~     other fruits and vegetables, as well as whole grains, and excludes meat other than fish as~     well as dairy and refined sugars and limits salt. Subjects are randomly assigned to the~     dietary intervention or to the non-intervention group. The non-intervention group will be~     invited to attend regular meetings with a focus on wellness in MS however will not receive~     specific dietary instructions. At the end of the study those who were not in the dietary~     intervention group will have the opportunity to receive all of the materials used during the~     study should they wish to begin the diet.~   "
44305|NCT02986880|"~     The main objective of the study is to estimate the efficiency and to determine the optimal~     dose of Botulinum toxin A, administered by intramuscular way in cervical spasms after~     radiotherapy, as well as the optimal sites for these injections.~      The concerned muscular groups are the sternocleidomastoid (SCM), the trapezius muscle and the~     splenius capitis.~   "
44306|NCT02986867|"~     The study is an exploratory prospective, single center study with correlative endpoints. The~     study will investigate the association of tumor cGAS STING signaling with SAbR. Tumor core~     biopsies will be processed and analyzed as described above. Medical records electronic~     medical records will be used to collect demographic and medical information and imaging~     studies.~   "
44307|NCT02986854|"~     The purpose/aim of this study is to assess the safety and antibody response to vaccination~     with a booster dose of Menveo given 4-6 years after primary MenACWY vaccination and to assess~     the safety and antibody response to a single dose of Menveo given to vaccine-naïve subjects~   "
44314|NCT02986750|"~     Dry eye syndrome is a highly prevalent ocular disease with an increasing incidence in the~     elderly population. Topically administered lubricants are the basis for treatment of this~     disease. However, exact information about influence on tear film thickness and corneal~     residence time of topical lubricants is still sparse, therefore no ideal treatment regimen~     has been found.~      Recently a new method for assessment of tear film thickness based on ultra-high resolution~     optical coherence tomography (OCT) has become available. The aim of the present study is to~     assess the influence on tear film thickness of three different formulations of topical~     lubricants, in particular Thealoz Duo® Eye Drops, Optive® Eye Drops and Systane Ultra® Eye~     Drops in patients with moderate to severe dry eye disease. In addition, standard tests for~     dry eye syndrome, such as the ocular surface disease index (OSDI©), Schirmer I test, corneal~     fluorescein staining and determination of tear break up time (BUT) will be performed to~     compare the product effects.~   "
44308|NCT02986841|"~     This is a 4-phase study to implement the NIDA (Common Data Elements) Common Data Elements~     (CDEs) in primary care settings. The study will be conducted at three adult primary care~     clinics, in two large health systems. Each phase will include deliverables essential to move~     to the next phase, and an independent Advisory Committee will review progress and make~     recommendations at each transition about how best to progress to each subsequent phase. Based~     on progress during earlier phases, the Advisory Committee may recommend expansion to~     additional clinics or health systems during the second part of Phase 4.~      Phase 2 prepares for implementation of the screening and CDS tools as part of routine~     clinical practice. A key component of this phase is tailoring the screening and CDS tools~     through an iterative process of usability testing and adaptation of their design. In the KTA~     framework, this phase corresponds to the 'select, tailor, and implement interventions' step.~     Simultaneously, investigators will plan for implementation in one clinic of the MSHS system~     by identifying clinical champions, educating clinic leadership and staff, and conducting a~     workflow analysis to identify barriers and facilitators of implementation.~   "
44309|NCT02986828|"~     Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with~     involving compression of the median nerve in the carpal tunnel. Rather than other progressive~     disease, CTS is characterized by remission and recurrence. Although many conservative~     managements of CTS, the effectiveness of these methods is insignificant or only persist for a~     short duration. The platelet rich plasma (PRP) is a new and potential treatment for patients~     with kinds of musculoskeletal disorders and recent reports showed being beneficial for~     peripheral neuropathy in animal studies. Since 2014, three small clinical trials showed the~     positive effect of PRP in peripheral neuropathy included CTSin a pilot research. However,~     these studies have not entirely proved the effects of PRP on peripheral neuropathy because~     these studies enrolled small number of patients and lacked controlled design. The~     investigators design a randomized, double-blind, controlled trail to assess the effect after~     ultrasound-guided PRP injection in patients with CTS.~   "
44310|NCT02986815|"~     At each point that the patient will have [11C]-Acetate PET study, this will be compared with~     standard clinical MR imaging. Abbreviations: XRT - radiation therapy; TMZ - temozolomide~     (chemotherapy)~      Quantitative Image Data Analysis: The [11C]-Acetate uptake in tumor sites from images will be~     analyzed qualitatively by visual assessment, quantitatively using a standard uptake value~     (SUV) in the tumor relative to the contralateral normal brain, and the parameters obtained by~     compartmental modeling of dynamic data.~   "
44311|NCT02986802|"~     Preterm delivery (PTD), together with low birthweight (LBW), is the leading cause of infant~     death and illness, affecting 500,000 births with annual medical costs of more than $26~     billion in the U.S. each year. Identifying changeable risk factors to reduce PTD is~     considered a top research priority. Recent research has shown genital herpes infection (HSV)~     is associated with increased risks of PTD and LBW. More importantly, treating this infection,~     including infection with no symptoms, using readily available antiviral medications can be~     effective in removing the risk due to HSV. Thus, early identification and treatment of HSV in~     pregnant women could be an effective way to prevent PTD and LBW. Currently, many pregnant~     women with HSV infection, especially those with no symptoms, choose not to treat due to (a) a~     lack of demonstrated benefit of treatment and (b) general hesitance to use medications during~     pregnancy due to safety concerns for the fetus. Thus, emerging evidence of an increased risk~     of PTD/LBW associated with HSV infection, if untreated, and treatment effectiveness by~     anti-herpes medications has significantly changed current treatment paradigms among pregnant~     women. This evidence also provides new hope that effectively treating HSV infection among~     pregnant women, especially before the 3rd trimester, could lead to a new method to reduce PTD~     and LBW and reduce racial/ethnic disparities in these risks due to high rates of the~     infection in minority groups. Thus, to further examine the effectiveness of treating HSV in~     pregnant women to reduce adverse pregnancy outcomes, the investigators propose to conduct a~     prospective cohort study with a two-stage design combining the large pregnant women~     population (N=90,000) in Stage I identified through Kaiser Permanente Northern California~     (KPNC) electronic medical records (EMRs), with a Stage II sample to collect detailed~     information on additional factors that might muddle our understanding of this issue. This~     study will address the following: (1) Does treating HSV infection in pregnant women reduce~     the risk of PTD or LBW? (2) Does timing of the treatment during pregnancy influence treatment~     effectiveness? (3) Do other factors influence treatment effectiveness? and (4) Does HSV~     infection in pregnancy, if untreated, increase the risk of PTD and LBW, compared to no~     infection? Answers to these questions will be valuable to pregnant women and clinicians, and~     directly address their concerns when making treatment decisions~   "
44312|NCT02986776|"~     A prior study in a tightly controlled clinical research environment found individuals with an~     alcohol use disorder (AUD) benefited more from inpatient (IP) than outpatient (OP) care, if~     they presented with high alcohol involvement and/or low cognitive functioning. This study~     sought to: (a) validate and extend these findings within the uncontrolled environment of a~     community-based treatment center, and (b) test whether inpatients had fewer days of~     involuntary abstinence (e.g., incarcerations) relative to outpatients. Based on their need~     for inpatient treatment, using prior cut-points for alcohol involvement and cognitive~     functioning, participants were randomly assigned within inpatient need group (No Need for IP;~     Needs IP) to either 21-days of inpatient substance misuse treatment or 21-days of outpatient~     treatment, all followed by 6 months of continuing outpatient care. Follow-up were conducted~     an 90-day intervals across 18 months.~   "
44313|NCT02986763|"~     An association has been suggested with several diseases including cancer and IARC has~     classified several pesticides as carcinogenic, probably carcinogenic. There is a need for a~     better characterisation of environmental pesticides exposures and identification of suitable~     biomarkers of exposure and effect. A better understanding of the impact of pesticide exposure~     on metabolomic, transcriptomic and epigenetic changes, is essential to strengthen~     epidemiological hypotheses on the association with several cancer types.~      The main objective of the project is to validate a GIS (geographic information system) based~     method to assess environmental pesticide exposures, using environmental (contamination of~     housedust) and biological (blood and urine samples) measures. The project aims further to~     investigate a potential link between housedust contamination and biological measures in~     healthy non-smoking male residents and explore the impact of environmental pesticide exposure~     on metabolomics, transcriptomic and epigenetic parameters.~   "
44315|NCT02986737|"~     Trial of ACURATE neo(TM) Aortic Bioprosthesis for Implantation using the ACURATE TA(TM) LP~     Transapical Delivery System in Patients with Severe Aortic Stenosis for evaluating the Safety~     and performance of the study device~   "
44316|NCT02986724|"~     The purpose of this non-interventional study (NIS) study is to assess further knowledge on~     the routine use of Entyvio in inflammatory bowel disease therapy, particularly the use in~     participants with CD and UC naive to biologics.~   "
44366|NCT02986074|"~     The study will compare therapeutic efficacy of a novel spinal cord stimulation leads implant~     based on anatomical landmarks with standard surgical implantation technique.~   "
44392|NCT02985736|"~     A single center, study of 20 subjects to assess 4 weeks of therapy with Topicort® twice daily~     BID and 12 weeks twice daily on 2 consecutive days to patients with scalp psoriasis~   "
44319|NCT02986685|"~     The research aims to investigate whether trimebutine maleate combined with rabeprazole can~     improve the clinical efficacy in patients With refractory Los Angeles grade A or B reflux~     esophagitis . A total of 500 patients with Grade A or B reflux esophagitis refractory to~     rabeprazole will be randomly divided into two groups.One will continue to receive rabeprazole~     treatment,and the other group will receive extra oral trimebutine maleate 200 mg three times~     daily for 4 weeks. The end of the study for every patient is the improvement of main~     symptoms. The primary and secondary analyses are the main symptoms score, endoscopy results,~     Gastroesophageal reflux disease questionnaire（GerdQ) score,Hospital Anxiety and Depression~     Scale(HADS) score, Athens insomnia scale and World Health Organization Quality of~     Life-Bref(WHOQOL-BREF)scale scores at the baseline and final assessments.~   "
44320|NCT02986672|"~     This study aim to evaluate the effect of marine monounsaturated and polyunsaturated fatty~     acids on children aged from 6-13 years, with ADHD/ADD and related symptoms. The study is a~     randomized, double-blind placebo-control study including approximately 330 children from~     Norway. The primary outcome measure is ADHD core symptoms reported by caregivers, teachers~     and the child at 0 months (baseline), 6 months (end of treatment) and 12 months (6 months~     post treatment). The secondary outcome measures are reading and writing disabilities,~     cognitive functions, and physical Health.~   "
44321|NCT02986659|"~     Medical scientists have found that people with diabetes who take the drug Metformin have less~     age-related disease than those taking other treatments and researchers believe it may prevent~     numerous diseases and conditions that effect older people. In addition, metformin extends~     lifespan in some animal models of human disease. The purpose of this study is to see if~     taking Metformin causes changes in blood cells consistent with improved health and longevity~     in people who do not have diabetes. In this study Metformin will be compared to placebo. A~     placebo is a substance, like a sugar pill, that is not thought to have any effect on a~     participants disease or condition. In this study participants will either receive the active~     study medication, Metformin or placebo which is not active. Placebos are used in research~     studies to see if the drug being studied really does have an effect.~   "
44322|NCT02986646|"~     Lateral epicondylitis, commonly known as tennis elbow is a common cause of elbow pain~     encountered in primary care and specialty clinics. Although lateral epicondylitis is common,~     little consensus exists on the best way to treat it. Historically 80% of patients will get~     better with non-operative treatments (rest, NSAIDS, bracing and injections). In regard to~     efficacy of injections, recent large, prospective, randomized studies have shown minor~     improvements in the short term, but no long term benefits when compared to saline injection.~     Consistently, intra-articular injections have not been reported. The investigators suspect~     that elbow joint inflammation may be an underappreciated source of pain in lateral~     epicondylitis. The investigators' hypothesis is that patients receiving intra-articular~     injections will have greater improvement compared to patients receiving either no injection~     or an intra-tendinous injection.~   "
44323|NCT02986633|"~     The present observational prospective study aims at identifying echocardiographic parameters~     (based on the Left Bundle Branch Block (LBBB)-like contraction of the left ventricle (LV)~     ascertained using new methods of echocardiography including speckle tracking strain) that are~     linked to Cardiac Resynchronization Therapy (CRT) response and a better outcome following CRT~   "
44324|NCT02986620|"~     This is a study where there are no interventions planned. Investigators will only collect~     data already in the patient's history and analyze it. Particularly, we are interested in~     molecular data from AML patients.~      This means that patients will follow their regular diagnostic and clinical practice. The~     analyses will be conducted according to the routine diagnostic and clinical practice as well~     and no additional blood withdrawal will be performed.~   "
44325|NCT02986607|"~     The investigators hypothesise that parathyroid hormon (PTH) depletion interferes with normal~     activity of the hypothalamus-pituitary-adrenal (HPA)-axis and the~     renin-angiotensin-aldosterone-system (RAAS), which in turn may impact morbidity and quality~     of life. The main objective of the current study is to test if PTH deficiency influences the~     secretion of corticosteroids and whether any abnormalities in the HPA-axis and the~     RAAS-system can be reversed by PTH infusion.~   "
44326|NCT02986594|"~     In this clinical cohort study, the investigators observe the efficacy of low molecular weight~     heparin in the treatment of thrombophilia with recurrent pregnancy loss with a prospective~     randomized controlled trial.~   "
44327|NCT02986581|"~     The purpose of this study is to collect data of rapid response team activated patients~     prospectively~   "
44328|NCT02986568|"~     The purpose of this study is to compare standard treatment and fusion ontogenetic surgery~     (total mesometrial resection, laterally extended endopelvic resection, peritoneal mesometrial~     resection) for gynecologic cancer in order to evaluate treatment response, adverse effect and~     survival.~   "
44329|NCT02986555|"~     Current virtual reality device makes motion sickness and visual fatigue having limitation for~     recreation and other clinical approaches. Still there is no standardized quantification of~     motion sickness and visual fatigue measurement with objective approach. Current biofeedback~     accompanied with virtual reality would be promising tool for stress relief.~   "
44330|NCT02986542|"~     The use of USI has eased practical application of interventional procedures, and reduced~     complications and procedure durations. For vascular interventions with ultrasound imaging,~     short- or long-section imaging of vascular structures is performed. Both techniques have~     their own advantages and disadvantages.~      This study aims to compare the success rates of femoral artery catheterization using both~     imaging techniques.~   "
44331|NCT02986529|"~     To evaluate the Bioavailability for GV-971 capsules of 150 mg, 300mg, and 450mg after~     administration of single oral doses of 900mg in healthy Male subjects.~   "
44332|NCT02986516|"~     Comparative study on surgery versus definitive radiation therapy in primary localized sacral~     chordoma~   "
44333|NCT02986503|"~     The study is a first step of a process to establish the standard chemotherapy treatment with~     the aim to improve outcome for patients with these rare tumours. For this reason the study~     will be non-controlled clinical trial.~      In this regard, the study aims to determine the feasibility of intensive chemotherapy in this~     age group, and/or separate efficacy analyses according to the different histologic categories~     and whether the number of patients recruited by the co-operating groups permits future~     randomised studies.~   "
44334|NCT02986490|"~     Background: Antipsychotics can induce metabolic disorders such as obesity, hyperglycemia,~     dyslipidemia or metabolic syndrome. It has been observed that treatment with antipsychotic~     could be accompanied by a decrease in the concentration of serum magnesium. Low serum~     concentrations of magnesium are potentially a risk factor of cardiac sudden death (Peacock,~     2010). Hypotheses linking magnesium and pathogenesis of cardiovacuscular diseases are~     multiple. Also, it seems to exist a close relationship between magnesium and carbohydrate~     metabolism. Most studies on the subject have generally studied plasmatic magnesium.~      Objective : Describe the relationship between changes in serum and intra-erythrocyte~     magnesium and cardiometabolic risk in patients innitiating an antipsychotic treatment. A~     secondary objective is to specify the frequency, magnitude and time to onset of changes in~     plasma of magnesium levels under antipsychotic treatment.~      Methods : This is a pilot single-center prospective cohort. After inclusion, patients status~     (including magnesium levels) will be evaluated (1 and 3 months of treatment) and that status~     will define the exposure criterion. Included patients will be followed for 1 year during~     which cardiometabolic markers will be measured.~      Population : patients who are more than 18 years old with schizophrenia schizoaffective~     disorder or bipolar disorder, naive to antipsychotic treatment or off for more than 3 months~     and requiring the introduction of antipsychotic drug therapy. Patients will be recruited~     during consultations and stays in care units of Adult Psychiatry Unit of Montpellier~     University Hospital.~      Factor studied: serum and intra-erythrocytic magnesium levels at beginning and during the~     antipsychotic treatment measured by a unique analyzer center. Changes in levels of~     hypomagnesemia expected during the treatment will determine exposure groups.~      Outcome: cardiometabolic risk markers measured at the beginning and during the treatment will~     be fasting blood glucose, fasting plasma insulin, HOMA-IR [Ins (uU / mL) x Gly (mmol / L) /~     22.5], lipid profile (total cholesterol, LDL, HDL), BMI, waist circumference and ECG (QTc).~      Cofactors: age, sex, personal and family medical history, blood pressure, smoking, diet,~     physical activity, psychiatric disease, Global Impressions, anti-psychotic treatment and~     comedications.~      Perspectives : to show that decreased in magnesium levels observed among patients starting~     antipsychotic treatment is associated with deterioration of cardiometabolic risk markers. The~     demonstration of this association could explain at least part the increased cardiovascular~     risk observed in this population. In the longer term, the results of this study would argue~     the implementation of an intervention research project studying magnesium supplementation to~     minimize the metabolic effects of antipsychotic medications.~   "
44335|NCT02986477|"~     In children, specifically the intravesicle administration to study vesicoureteral reflux in~     children already catheterized and scheduled for voiding cystourethrogram (VCUG).~     Contrast-enhanced ultrasonography is a tremendous advancement from conventional B-mode and~     color Doppler ultrasonography, as it permits noninvasive, non-ionizing delineation of~     physiology and pathophysiology with higher resolution and accuracy in children. The technique~     is particularly useful in pediatric population whose lifetime risk of cancer significantly~     increases with higher frequency of ionizing radiation. Voiding cystourethrogram is a~     fluoroscopy technique that can study reflux real time but at the risk of radiation side~     effects. In this regard, intravesicle administration of ultrasound contrast agent can help~     avoid radiation in children and potentially replace the conventionally used voiding~     cystourethrogram.~   "
44336|NCT02986464|"~     Procedural pain is the most intense and often undertreated pain associated with burn~     injuries. The use of analgesics does not always provide optimal relief and is accompanied by~     several side effects. Indeed, children with burn injuries still experience severe pain~     intensity during procedures despite the fact that doses of analgesics used with this~     population has almost doubled in the last twenty years. Current guidelines on pediatric~     procedural pain management recommend the combination of non-pharmacological and~     pharmacological interventions to enhance pain management and decrease the numerous side~     effects of analgesics. Distraction has been identified among the most effective~     non-pharmacological interventions for pain as it diverts the child's attention to an~     attractive element, hindering the perception of the painful stimuli. Virtual reality is a~     method of active distraction that offers the child a multi-sensory immersive interaction that~     found many applications for pain management in adult patients. However, very few studies have~     tested the efficacy of distraction by virtual reality on procedural pain and anxiety in~     children with burn injuries.~      This RCT follows a pilot study (NCT02794103) aimed at assessing the feasibility of a virtual~     reality prototype developed specifically for the hydrotherapy room of children under seven~     years old for the relief of procedural pain in children with burn injuries. The aim of the~     RCT will be to evaluate the effectiveness of the virtual reality prototype in relieving~     procedural pain in children from 6 months to 7 years old undergoing hydrotherapy session for~     burn injuries.~   "
44337|NCT02986451|"~     This phase II study investigating the efficacy and safety of a combination of~     biaxin,lenalidomide and dexamethasone in subjects with relapsed/refractory MM.~   "
44338|NCT02986438|"~     The purpose of this study is to investigate the short and long term clinical and cognitive~     effects of repetitive Transcranial Magnetic Stimulation (rTMS) at 5 Hz and/or 10 Hz~     frequencies on the left dorsolateral prefrontal cortex in cocaine dependent patients and to~     examine possible changes in brain structure and functional connectivity associated with this~     intervention.~   "
44339|NCT02986425|"~     The objective of this Randomised Controlled Trial (RCT) is to evaluate whether the Systematic~     Tool to Reduce Inappropriate Prescribing (STRIP) including STRIP assistant (STRIPA)~     implemented by an appropriately qualified team will lead to an improvement in clinical and~     economic outcomes among patients aged 70 years and more with multimorbidity and polypharmacy.~   "
44340|NCT02986412|"~     We would suggest to conduct VOLUME-2 study, as an extension of the ongoing VOLUME study~     with all subjects already included. After completion of VOLUME study, the study will be~     directly extend with an open-label design. All participants, who agreed to pursue, with~     either Placebo or CG428, will receive CG428 treatment for an additional six-month period.~     VOLUME-2 study would be ideal and timely by enabling no interruption of product use.~      The Primary Objective is to observe for a longer period the efficacy of CG428 (12 months :~     6months Volume + 6 months Volume-2) in order to better discriminate later or non-responder~     populations.~      Secondary Objectives are :~        -  Evaluate how far CG428 can improve hair-pattern (reach a plateau or constant~          progression)~        -  Evaluate motivation and adherence of subjects~        -  Long term safety~   "
44341|NCT02986399|"~     The study examines if the introduction of a fast track pathway for hip fracture patients had~     an influence on mortality and quality of life by comparing these outcomes between all hip~     fracture patients operated at Akershus University Hospital two years before and two years~     after this change in standard care.~   "
44342|NCT02986386|"~     Oral health is a critical factor of systemic health, although usually forgotten. A potential~     relation between cognitive deficits and oral diseases has been suggested. Adult cognitive~     dysfunctions have a high impact, not only economic, but social and in the family environment.~     Based on anatomical connectivity between the oral cavity and the central nervous system, the~     proposed study hypothesizes that masticatory function is a relevant determinant of human~     cognitive health. The restoration of canonical masticatory function and masticatory training~     could help to delay the development of such conditions. This project will also test if~     restoring phasic masticatory function improves the execution of cognitive tasks.~   "
44344|NCT02986360|"~     1. To develop brief informational videos, Vidscrips, that can be sent to women following~          their mammogram to provide personalized information that integrates breast density with~          overall breast cancer risk, and provides information about additional care~          recommendations and talking tips for conversations with the health care providers.~        2. To test the effectiveness of this tool in a trial of 300 women undergoing mammography.~          The investigators hypothesize that individuals in the intervention arm (vs. those in the~          standard care arm who receive a letter with the language required by the legislation)~          will have more accurate knowledge of their overall risk of breast cancer, their~          Mammographic Breast Density (MBD) result, more appropriate observed and intended use of~          additional screening [i.e., use of screening Magnetic Resonance Imaging (MRI) will be~          reserved only for women at high risk of breast cancer], better satisfaction with their~          episode of breast cancer screening, less decisional conflict about their personal~          decision for any additional evaluation, and less worry about breast cancer.~   "
44345|NCT02986347|"~     The anesthetic technique of choice for surgical treatment of CTS varies among surgeons. In~     the last decade some studies have described the performance of this surgery using local~     anesthesia with adrenaline without the necessity of sedation or the use of pneumatic garrote,~     having good effectiveness and substantial reduction of costs. However there is need for~     studies with an appropriate design and methodology to evaluate the actual effectiveness of~     this kind of anesthesia for the surgical treatment of CTS.~      Objective: To evaluate the effectiveness and cost of open surgery for CTS in a randomized~     trial comparing two anesthesia methods: intravenous regional anesthesia (Bier) and local~     anesthesia with adrenaline without limb garroting (Lalondi).~      Methods: This study was developed in the Group of Hand Surgery and Upper Limb; Department of~     Orthopedics and Traumatology, Federal University of São Paulo, UNIFESP / EPM with~     co-participation of the Hand Surgery and Microsurgery Department of Hospital Alvorada. This~     study will be a Randomized Clinical Trial. The previous calculation of the sample resulted in~     78 patients. The following primary outcomes will be assessed: Pain through visual analogue~     scale (VAS). Costs: Costs related to anesthetic and surgical procedures will be recorded. The~     secondary outcomes will be: Use of Analgesics, Anxiety and Depression through the HADS~     (Hospital Anxiety and Depression Scale) scale. Quality of life through the Boston Carpal~     Tunnel Syndrome Questionnaire (BCTQ). Remission of paresthesia after surgical intervention,~     complications and failures.~   "
44346|NCT02986334|"~     This study is designed to examine brain properties for placebo response in chronic back pain~     patients. The investigators have preliminary data indicating that, in blinded clinical trial~     studies with neutral instructions regarding treatment, chronic back pain (CBP) patients can~     be subdivided into placebo responders and non-responders, and these differences are~     PREDICTABLE a priori, by brain activity. The results imply that CBP placebo may have clinical~     utility and that its properties can be studied by human brain imaging techniques. In Phase I~     of the study, the investigators seek to identify brain imaging parameters that predict the~     propensity for the placebo response in an independent CBP cohort. In Phase II, the~     investigators will evaluate the interaction between placebo response and medication treatment~     in individuals stratified as placebo responders versus non-responders. This research is~     designed to critically assess the neurobiology of placebo analgesia for chronic pain in a~     partially-blind clinical trial.~   "
44347|NCT02986321|"~     The purpose of this study is to evaluate the dose-response relationship of different doses of~     CHF6001 and to identify the optimal dose (s) in terms of benefit/risk ratio for further~     development in the target patient population.~   "
44348|NCT02986308|"~     The aim of this study is to confirm the TCM syndrome types and TCM constitution~     classifications of the patients with intestinal polyps via on-site epidemiological survey, to~     analyze metabolomics of the serum samples of intestinal polyps and healthy volunteers, and to~     study the metabolomics differences of the two populations and the metabolomics variations of~     the patients with intestinal polyps of pre-polypectomy and post-polypectomy. Finally, this~     study is to investigate the serum metabolomics variations of patients with intestinal polyps~     of pre-polypectomy and post-polypectomy and the relationship with their TCM syndrome types~     and TCM constitution classifications, to determine the correlation among pathology, TCM~     constitution, TCM syndrome types and the metabonomics variations of patients with intestinal~     polyps.~   "
44349|NCT02986295|"~     Comparison of safety and long-term effects of BioMimeTM stent and Ultimaster® stent with~     Xience® stent~   "
44350|NCT02986282|"~     Consecutive patients with atrial fibrillation will be admitted to the hospital for electrical~     cardioversion. Ankle brachial index will be measured three times with oscillometric method~     and three times with doppler method. Two study sessions will be performed: the first before~     and the second after electrical cardioversion. The first session will be ended before~     anesthesia. The second session will be started before a conscious patient will be transported~     from intensive care unit to general ward.~      All the measurements will be taken in the intensive care unit at an ambient temperature of~     21° C, after patients will give their written informed consent to participate in the study.~     All patients will be awake, fasting and in the supine position. ABI will be measured~     according to the guidelines issued by AHA. Systolic blood pressure will be measured using a~     Doppler device (Echo Sounder ES-101EX, Hadeco, Japan) and a validated and calibrated aneroid~     sphygmomanometer (Minimus II, Rister, Germany). Measurement of ABI using oscillometric method~     will be performed using WatchBP Office ABI system (Microlife WatchBP AG, Widnau,~     Switzerland). The appropriate cuff size will be used with the width of the cuff being at~     least 40% of the limb circumference. The arm with higher systolic blood pressure will be used~     to calculate the ABI. Higher systolic blood pressure measured on the posterior tibial or~     dorsalis pedis artery will be used to calculate the ABI. During both study sessions ABI~     measurements will be repeated 3 times with each method in the reverse order of the preceding~     measurement e.g., in the case of the initial counterclockwise sequence: right arm, right~     popliteal, right dorsalis pedis, left popliteal, left dorsalis pedis, left arm, right arm,~     the clockwise sequence will be used, starting and ending with the left arm. The same sequence~     of limb pressure measurements will be used used during the study.~      A sample size calculation was based on the preliminary observations made by the study team.~     It was calculated that the study sample size of 79 subjects would be needed to detect a~     difference of 0.1 in the ABI measured in sinus rhythm and during atrial fibrillation, with a~     two-tailed α of 0.05 and a (1-β) of 0.90. The investigators initial estimate of sample size~     of 115 patients incorporated an assumption of dropout due to non-effective electrical~     cardioversion, patient decision to quit study or failure to obtain adequate ABI.~      The measurements will be repeated three times with each method and for the each method the~     mean will be used for the calculations. Investigator - study nurse, trained at the vascular~     department, will perform all ABI measurements.~   "
44351|NCT02986269|"~     General anesthesia has been demonstrated to have a negative impact on lung function. Both~     surgery and patient position influence the perioperative lung function. Laryngeal mask airway~     (LMA) has been proved to be safe and efficient to maintain the airways patent during general~     anesthesia. Pressure support ventilation (PSV) with LMA is routinely used in clinical~     practice. The aim of the present trial is to characterize perioperative changes in lung~     volume, ventilation inhomogeneity and respiratory mechanics in patients in the lithotomy~     position and spontaneously breathing through LMA with and without PSV.~   "
44352|NCT02986256|"~     The TELEPIED project aims to show that it is possible to reduce the number of hospitalization~     days of a patient with ulcers of the foot thanks to a new organization of care, based on the~     intervention of a coordinating nurse interacting with the nurse in charge of the patient~     thanks to a telemedicine tool allowing the transfer of photos and ensuring itself a regular~     follow-up of the evolution of the wound and adapting the support nurse to the home if~     necessary.~      It is a monocenter, randomized, in parallel study, in 180 diabetic patients with ulcers of~     the foot.~      Patients included in the conventional group will be followed according to the usual practice~     Patients included in the telepied group will benefit from a personalized accompaniment by a~     nurse referring to diabetic foot ulcers who will guide and advise the nurse at home by acting~     by delegating tasks of the investigator.~      The patient will be visited by the referring nurse every 15 days. During these visits, the~     referring nurse will have the objective to evaluate the evolution of the ulcer as well as the~     care performed. This visit also allows a close personalized accompaniment for the patient,~     who will benefit from an education adapted to the characteristics of ulcer (discharge~     modalities for example ..) and its way of life.~      Every patients will be followed for one year (12 months).~   "
44353|NCT02986243|"~     The purpose of this study is to determine if an assigned physical fitness program will result~     in weight loss to prepare patients for kidney transplant.~   "
44354|NCT02986230|"~     The objective of this project is to implement and evaluate the effectiveness of a~     sophisticated Web-based, electronic health record (EHR)-linked clinical decision support~     (CDS) system designed to improve primary and secondary cancer preventive care.~      This project will engage a rural population with substantial healthcare disparities and gaps~     in the receipt of primary and secondary cancer prevention. Results will advance dissemination~     and implementation research methods that can reduce health disparities and improve healthcare~     for millions in medically under-served areas.~   "
44355|NCT02986217|"~     This study seeks to establish the effect of regular structured feedback on surgical~     performance using crowd sourced video assessments with validated objective performance scores~     and time to complete a specific surgical procedure through a randomized controlled trial. The~     working hypothesis is that regular structured assessment will lead to a greater measurable~     improvement in performance, as defined by objective performance scores, than will traditional~     feedback methods.~   "
44356|NCT02986204|"~     This study will investigate in-office ultrasound localization vs localization in radiology~     for identification and removal of non palpable etonogestrel (ENG) contraceptive implants and~     aims to help establish best practices in this domain. Investigators will also create an~     ultrasound image gallery of palpable and non palpable as well as instructional video for non~     palpable ENG implant removal.~   "
44357|NCT02986191|"~     Twenty patients with gingival recession will be enrolled in this trial. Gingival recession~     will be treated in one side by applying Mucograft® with coronally advanced flap (CAF) while~     on the opposite side a connective tissue graft (from the palate) will be applied with a CAF.~      Patients will be followed for 3 and 6 months by measuring the clinical indexes and~     statistical analyses will be performed to compare the results and to assess the success of~     Mucograft®.~   "
44358|NCT02986178|"~     This is a randomized phase 2 study of oncolytic polio/rhinovirus recombinant (PVSRIPO) alone~     or in combination with the chemotherapy drug lomustine in adult patients with recurrent World~     Health Organization (WHO) grade IV malignant glioma at the Preston Robert Tisch Brain Tumor~     Center (PRTBTC) at Duke.~   "
44359|NCT02986165|"~     This study evaluates the acute and longer term effects of a tomato pomace extract on platelet~     aggregation in health subjects.~   "
44360|NCT02986152|"~     The Cancer Distress Coach (CDC) mobile app is a symptom management tool for posttraumatic~     stress disorder (PTSD) in cancer patients and caregivers. Based largely on PTSD Coach from~     the National Center for PTSD, the CDC app was redesigned for both iOS and Android platforms~     and is tailored specifically to individuals impacted by cancer.~      This study aims to evaluate whether CDC app usage influences symptoms of PTSD through a~     randomized controlled trial (RCT) where subjects are placed into either the intervention~     group or the wait-listed control group for a period of 8 weeks. The CDC app is available as a~     free download on the App Store® and on Google Play™.~   "
44361|NCT02986139|"~     Assess the injection site pain associated with a New Etanercept formulation in adult subjects~     with RA or PsA~   "
44362|NCT02986126|"~     Depressive symptoms and disorders are among the most common adult health conditions with a~     lifetime prevalence of 15-20% and are a leading cause of disability /morbidity worldwide.~     Although evidence-based approaches such as cognitive behavioral therapy (CBT), antidepressant~     medications, and depression collaborative care and quality improvement (QI) programs~     integrating depression care into primary health care can improve depression outcomes and~     disparities, racial / ethnic disparities continue to persist. Concurrently, according to a~     2011 Institute of Medicine (IOM) report, little information exists on how to address the high~     rates of depression among sexual and gender minorities.~      Our study randomizes depressed, LGBTQ (lesbian, gay, bisexual, transgendered, queer), racial~     / ethnic minority adults to an evidence-based agency-level, depression quality improvement~     (QI) training [Resources for Services (RS)] and technical support alone or to a resiliency~     class (RC+), a 7-session resiliency, cognitive behavioral therapy class to enhance mood +~     automated mobile text reminders about basic reminders and care follow-up impact on improving~     adult patients' depressive symptoms. Depression QI (RS) training will be offered to three~     clusters of four to five LGBTQ-focused programs: two clusters in LA (Hollywood and South LA)~     and one cluster in NO. Clusters are comprised of one primary care, one mental health, and two~     to three community agencies (e.g., faith-based, social services/support, advocacy). All~     programs will receive depression QI training. Enrolled adult depressed patients (n=320) will~     be randomized individually to RC+ or RS (depression QI) alone to assess effects on primary~     outcomes: depressive symptoms [8-item patient health questionnaire (PHQ-8) score and~     secondary outcomes: mental health quality of life [12-item mental composite score (MCS-12) ≤~     40], Resilience (Brief Resilience Scale), mental wellness, and physical health quality of~     life [12-item physical composite (PCS-12)score] at 6- and 12-month follow-up.~   "
44363|NCT02986113|"~     This study will determine if suicidal middle-aged men who use a personalized computer program~     addressing suicide risk before a primary care visit are more likely to discuss suicide and~     accept treatment, reducing their suicide preparatory behaviors and thoughts.This is important~     because half of all men who die by suicide visit primary care within a month of death, yet~     few broach the topic, missing chances for prevention.~   "
44364|NCT02986100|"~     The purpose of this study is to characterize the mass balance, absorption, metabolism, and~     elimination pathways of orally administered [14C] rucaparib followed by cycle by cycle~     treatment with rucaparib continuing until disease progression or other reason for~     discontinuation~   "
44365|NCT02986087|"~     Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses.~   "
44370|NCT02986022|"~     Background:~      Resilience is important for successful adaptation. The investigators' resilience intervention~     was effective in enhancing resilience, emotional functioning, and adaptation in Mainland~     immigrants. In the present proposal, the investigators will work with the International~     Social Service to scale up application of this intervention in immigrants, and develop the~     training infrastructure to ensure that the evidence-based intervention can be sustained~     despite turnover of interventionists.~      Objectives:~        1. We will conduct a randomized controlled trial to compare the resilience intervention~          with the resilience + information intervention (a compound module) among 200 new~          immigrants,~        2. The resilience intervention will enhance participants' resilience by 5%, and decrease~          their depressive symptoms by 20% and adaptation difficulties by 10% after the completion~          of the intervention,~        3. The resilience + information intervention will have higher increases in resilience and~          more decreases in depressive symptoms and adaptation difficulties compared to the~          resilience intervention, and~        4. To establish a sustaining mechanism which ensures that these two interventions can~          continue to be used in routine services.~      Project design:~      Well-trained social workers will deliver the intervention. Participants will complete~     programme evaluation. A train-the-trainer workshop and training materials will be prepared to~     transfer knowledge to social workers who are future trainers.~   "
44371|NCT02986009|"~     The collaborator has its vision as To have children, individuals, families and migrants~     across countries live in dignity and harmony, and be contributing members to a just, humane~     and caring society. Parents are very significant in the families as they need nurturing,~     discipline, teaching, monitoring, and managing their children as well as their families.~     Capable and competent parents bring good child outcome and happy family. The investigators~     planned to serve targeted parents in two areas as 1. Emotion management and 2. Information on~     community resource. In the first set, the participants are expected to improve their emotion~     management leading to a more effective parenting. In the second set, the participants would~     acquire more information that enables them to better use the community resources.~      To work closely with the collaborator, and based on the previous results of an effective~     parenting intervention, the investigators will modify the intervention to tailor the needs of~     targeted parents. The objectives are:~        1. After completing the parenting intervention, 150 participants will, 1.1. To increase~          participants' emotion management strategies by 20%, 1.2. To enhance positive affect by~          10%, 1.3. To decrease negative affect by 10%, 1.4. To enhance satisfaction with the~          parent-child relationship by 10%, 1.5. To increase subjective happiness by 8%, 1.6. To~          enhance family harmony by 5%, These levels of positive effects of the program were~          projected from the investigators' published findings.~        2. After joining the information sessions about education, health care, housing,~          employment, and community facilities, another 150 participants will, 2.1 To know more~          information of Hong Kong by 50%, 2.2 To know more information of Mainland China by 50%,~          2.3 To use more community resources either in Hong Kong or Mainland China by 50%.~      To study the effectiveness of parenting intervention, the investigators proposed to use a~     randomized controlled trial (RCT) that is a type of scientific study to reduce bias.~     Participants in this project will be randomly allocated to either the emotional management~     group or the information group. As the information group has no focus on parenting,~     participants would show no significant improvement in emotion management strategies or~     satisfaction with the parent-child relationship, etc. Meanwhile, participants in the~     parenting intervention would show no significant improvement in knowledge about either Hong~     Kong or Mainland China.~   "
44372|NCT02985996|"~     The purpose of this study is to determine the ability of new anti-HIV agents to penetrate~     different body compartments in HIV negative men who have sex with men and transgender women.~     These new agents might be considered for pre-exposure prophylaxis regimens in the future.~     This study will include 90 healthy, HIV-negative men who have sex with men and transgender~     women who are not taking hormones aged 18-49 years. Participant must be willing to~     participate in 1 of the 3 study phases, be willing to take Truvada® (PrEP) or Genvoya®, and~     willing to undergo blood draws, urethral swabs, and rectal biopsy procedures.~   "
44373|NCT02985983|"~     To evaluate the efficacy of KHK4827 in axSpA (ankylosing spondylitis [AS] and~     non-radiographic axial spondyloarthritis [nr-axSpA]) subjects compared to placebo, as~     measured by the proportion of axSpA subjects achieving an Assessment of SpondyloArthritis~     international Society (ASAS) 40 response at week 16.~   "
44374|NCT02985970|"~     Rapid sequence induction (RSI) is a common part of routine anesthesiology practice.However~     several steps of RSI are not based on evidence based data (EBM) and are considered~     controversial. In an electronic evaluation form that will be send to Czech society of~     anesthesiology, resuscitation and intensive care (ČSARIM) members, the investigators bring 4~     clinical scenarios in which RSI should be used. In the questionnaire the participants have to~     choose RSI or no and they have to describe all the next steps on anesthesia induction process~     in each single clinical scenario.~   "
44375|NCT02985957|"~     The purpose of this study is to determine whether nivolumab plus ipilimumab has preliminary~     evidence of safety and effectiveness in treatment of metastatic castration-resistant prostate~     cancer~   "
44376|NCT02985944|"~     Colonoscopy outcome is strictly related to the adenoma detection rate (ADR). An endoscopy~     withdrawal time >6min has been suggested to increase the ADR since it allows for thorough~     evaluation of the several hidden areas of the colon. The FUSE, full spectrum endoscopy~     system, has been demonstrated to reduce the rate of missed lesions due to its wide-angle~     view. In the present study the authors evaluate the impact of WT on ADR for High Definition~     Standard Endoscopes with just a single imager to the FUSE endoscope.~   "
44377|NCT02985931|"~     The investigators aim to address this issue with novel image quantification methods using~     CZT-based SPECT, which is capable of dynamic data acquisition and therefore feasible for the~     quantification of the coronary flow. The investigators will use kinetic modeling techniques~     to design a study that allows the absolute flow quantification. To make this study practical,~     the investigators will develop a protocol that includes the acquisition of both the rest and~     stress scan within the same scan that is shorter than 30 minutes. The SPECT-measured flow~     will be validated against the flow measured with cardiac MRI scans. Patients with high CAD~     risk will be recruited for the clinical trial. Data from these human subjects will be used~     for determination of the performance of the developed algorithm. With the proposed rapid scan~     with absolute quantification capabilities, the investigators expect to increase the diagnosis~     accuracy while maintaining the patient throughput.~   "
44378|NCT02985918|"~     The main purpose of the present study is to verify whether, as compared with~     conventional-intensity noninvasive positive pressure ventilation, high-intensity noninvasive~     positive pressure ventilation may more effective in correcting hypercapnia, hence reducing~     the need for intubation and improving survival in patients with acute exacerbation of chronic~     obstructive pulmonary disease.~   "
44379|NCT02985905|"~     Although several studies have considered the relationship between infertility and semen thiol~     compounds levels, no study on the effects of asthenospermia treatments such as oral zinc~     supplementation on thiol related enzymes activity which are important in fertility of the~     individual has been reported.~   "
44380|NCT02985892|"~     The incidence of chronic nonspecific low back pain is the highest in the world population and~     can lead to disability. One of the standards treatments for this condition is the segmental~     stabilization exercises, as well as trunk stretching. However, there is no study that~     associates these two treatments for nonspecific low back pain. This study will be a~     controlled clinical trial, randomized, prospective, single-blind with a quantitative approach~     that compares the efficacy of the association between segmental stabilization + trunk~     stretching with segmental stabilization + placebo stretching in patients with chronic~     nonspecific low back pain.~   "
44381|NCT02985879|"~     The purpose of this study is to assess efficacy, safety, tolerability, and pharmacokinetics~     of ABBV-8E12 in subjects with progressive supranuclear palsy (PSP).~   "
44382|NCT02985866|"~     The objective of the study is to assess the efficacy and safety of home use of a~     Control-to-Range (CTR) closed-loop (CL) system.~   "
44383|NCT02985853|"~     The goal of this project is to examine the physical mechanisms that contribute to~     improvements of glucose tolerance in type 2 diabetes mellitus (DM) following certain types of~     bariatric surgery.~   "
44384|NCT02985840|"~     Nausea is a common complaint in patients who present to the emergency department (ED).~     Although the number of conditions that can present with nausea are numerous, the mainstay of~     treatment has become intravenous ondansetron (Zofran), not only due to its rapid onset but~     also its availability. One of the major drawbacks to using this form is that it often needs~     to be redosed. This study aims to compare intravenous (IV) ondansetron alone versus IV~     ondansetron given with IV dexamethasone (Decadron) as another viable option when treating~     patients with nausea in the emergency department.~      Previous studies in patients undergoing surgical procedures have shown that when IV~     dexamethasone is given with IV ondansetron to post-operative patients they have less nausea~     and vomiting than ondansetron alone, and were even found to show decreased post-operative~     pain associated with nausea. It has also been shown to decrease the need to re-dose~     antiemetic medication. Although this combination has not been tested in the emergency~     department it is believed by these investigators that the additional use of dexamethasone may~     decrease the need to use repeated doses of ondansetron.~      The investigators believe this may change the way physicians currently approach the nauseated~     patient in regards to treatment. That rather than possibly giving multiple doses of one~     medication over and over to reduce a patient's nausea, physicians can give two medications~     together at one time. The investigators hope to demonstrate that by giving intravenous~     dexamethasone and ondansetron together, it may be possible to reduce the number of patients~     who need additional doses of nausea medication.~   "
44385|NCT02985827|"~     The purpose of the study is to analyze the sensation to eye drops containing menthol in~     people with healthy eyes and in people with dry eyes. This study also examines the~     temperature of your eye using an Infrared Camera.~   "
44386|NCT02985814|"~     Background: Asthma and COPD are considered different diseases but many patients share~     characteristics of both entities. This has been termed COPD-asthma overlap syndrome.~      Study objective: To examine: (a) the frequency of the overlap phenotype among patients~     referred for pulmonary function testing and, (b) the impact of this phenotype on the~     therapeutic management and the quality of life of these patients as compared with patients~     with COPD only and asthma only.~      Methods:~      Type of study: Observational, cross-sectional. Study subjects: Patients referred for~     pulmonary function test diagnosed with airway obstruction (FEV1/FVC < 0.7) willing to sign an~     informed consent.~      Study procedures: Spirometry will be performed before and after the administration of a~     bronchodilator. Respiratory questionnaire: Questionnaires about smoking habits, past history~     of asthma and wheezing, current medications and history of exacerbations will be administered~     at inclusion. Questionnaire on medication utilization will be administered by telephone one~     month after inclusion. Quality of life: Will be assessed using the Saint George Respiratory~     Questionnaire (SGRQ).~      Working definitions: The following definitions will be adopted: a) COPD only: smoking history~     > 10 pack/years and post-bronchodilator (BD) FEV1/FVC ratio of < 0.70; b) Asthma only: (1)~     presence of wheezing in the last year plus a minimum post-BD increase in FEV1 or FVC of 12%~     and 200 ml; (2) prior physician diagnosis (before age 40); and c) both COPD-Asthma (the~     overlap group) - the combination of the two.~      Outcome measures: The clinical outcome is the prevalence rate of the phenotypes.~     Patient-reported outcomes will include the utilization of medication, the number of~     exacerbations, and quality of life.~   "
44387|NCT02985801|"~     Does pancreas enzyme replacement (PERT) decrease weight loss and improve quality of life in~     patients with unresectable pancreatic cancer?~   "
44388|NCT02985788|"~     Loss of elbow range of motion can significantly affect activities of daily living. Measuring~     elbow range of motion is critical for tracking post surgical outcomes. This study seeks to~     validate the ability to validate self photography as a means of followup through long~     distance correspondence.~   "
44389|NCT02985775|"~     Cytomegalovirus (CMV) infections remain an important cause of morbidity and mortality in~     allogeneic hematopoietic cell transplant (HSCT) recipients, especially in patients received~     haploidentical transplantation. During the past decades, prophylactic or preemptive treatment~     with antiviral drugs has significantly reduce the incidence of early-onset CMV infection.~     Unfortunately, prolonged antiviral treatment is associated with substantial toxicity and may~     delay recovery of virus specific immune responses, resulting in an increasing of late-onset~     CMV disease.~      To date, adoptive immunotherapies have been developed as treatment alternatives to antiviral~     agents for CMV infection after HSCT. Studies have demonstrated that prophylactic or~     preemptive therapy with donor CMV-specific T cells can restore antiviral immunity and clear~     CMV viremia after transplantation. In this prospective clinical phase I/II trial, we propose~     to reconstitute antiviral immunity against CMV by preemptive transfer of CMV-specific T cells~     at an early time point after allogeneic stem cell transplantation. We also propose to~     demonstrate whether protect against CMV is associated with recovery of CMV-specific T cells.~   "
44390|NCT02985762|"~     The primary objective of this study is to characterize the pharmacokinetic (PK) profile of~     EXPAREL when administered via local wound infiltration to subjects undergoing open spinal~     fusion or reconstructive surgery.~      The secondary objectives of this study are to assess the safety, tolerability, and efficacy~     of EXPAREL in this surgical model.~   "
44394|NCT02985710|"~     Sudoscan™ (Impeto Medical, Paris France) uses electrochemical skin conductance as a novel~     noninvasive method to detect sudomotor dysfunction. Several small studies have recently shown~     that Sudoscan use in the assessment of small fiber polyneuropathy (in diabetes mellitus) can~     be performed non-invasively, quickly and effectively. The investigators aim to study the use~     of Sudoscan in rare disease condition associated with small fiber polyneuropathy.~   "
44395|NCT02985697|"~     The aim of this study is to evaluate the efficacy and safety of intranasal dexmedetomidine~     when used in combination with oral midazolam and/or nitrous oxide for moderate sedation~     during pediatric outpatient dental procedures.~   "
44396|NCT02985684|"~     Evaluate the safety and efficacy of the GORE® CARDIOFORM ASD Occluder in the percutaneous~     closure of ostium secundum atrial septal defects (ASDs)~   "
44397|NCT02985671|"~     The purpose of this study is to determine whether the fixed combination of orphenadrine,~     acetaminophen, caffeine and diclofenac sodium is more effective in the treatment of an acute~     episode of mechanical postural low back pain than Voltaren®. Will be randomized 110~     participants of both sexes, aged 18 years or older and less than 65 years of age with an~     acute episode of mechanical postural low back pain and they will be allocated to one of two~     treatment groups: Group 1: Fixed combination of orphenadrine, acetaminophen, caffeine and~     diclofenac sodium; or Group 2: Voltaren®~   "
44398|NCT02985658|"~     This is an expanded access protocol to allow continued maintenance therapy with ABT-888~     (veliparib) for three patients with metastatic triple negative breast cancer who are~     currently receiving the investigational product in association with clinical trial~     participation. Additionally, the protocol will enroll up to 7 new patients with metastatic~     BRCA associated or triple negative breast cancer to allow for additional access to veliparib~     monotherapy, or at the investigator's discretion, veliparib in combination with cisplatin~     and/or vinorelbine.~   "
44399|NCT02985645|"~     This study is intended to evaluate the efficiency of graftless maxillary sinus augmentation~     with concentrated growth factor (CGF) utilizing dynamic implant valve approach (DIVA)~     system.~   "
44400|NCT02985632|"~     An oral dose of BMS-986141 administered in Hepatic Impairment and Healthy Participants to~     evaluate pharmacokinetics in this patient population.~   "
44401|NCT02985619|"~     Background: Diabetic macular edema (DME) shows a sustained functional and morphologic~     response to anti-vascular endothelial growth factor (VEGF) drugs, but the optimal approach~     for persistent macular edema still in debate.~      Purpose: To evaluate 24-week visual and anatomical effects of intravitreal bevacizumabe or~     triamcinolone in patients who had residual edema after 24-weeks to pro re nata(prn)~     intravitreal bevacizumabe therapy.~      Methods: This study enrolled a total of 100 DME eyes. Each patient received prn~     bevacizumabe therapy throughout 24 weeks. At week 24, patients who had recurrent or~     persistent edema were randomized 1:1 to Group 1 (prn bevacizumane) or Group 2 (prn~     triamcinolone). Patients with no recurrent or persistent edema at week 24 were comprised~     Group 3 and continue received prn bevacizumabe. Prn treatment was administered when central~     subfield thickness of the macula (CST) > 300 µm and/or there were intraretinal cystoid spaces~     in the fovea. Study visits occurred every 4 weeks with the endpoint at week 48. At each~     visit, patients had an eye exam and CST, best-corrected visual acuity (BCVA), and intraocular~     pressure (IOP) were assessed. Fundus photography and fluorescein angiography were also~     performed at baseline, week 16, week 40, and week 48. Rescue therapy using laser~     photocoagulation could be administered at the discretion of the Investigators. All patients~     resumed standard care after exiting.~   "
44402|NCT02985606|"~     Investigate how manipulating the time between caffeine ingestion and exercise may alter~     exercise performance and cognition~   "
44403|NCT02985593|"~     The objectives of this study are to evaluate the safety and tolerability of a single~     intravenous (IV) or subcutaneous (SC) dose of KHK4083 in Japanese or White healthy men in a~     placebo-controlled, single-blind comparative study, and to evaluate the safety and~     tolerability of multiple IV doses of KHK4083 in subjects with ulcerative colitis in an~     open-label study.~   "
44404|NCT02985580|"~     Blueberries are rich in flavonoids that possess antioxidant and anti-inflammatory properties,~     which in rodent models are neuro-protective. The risk of developing dementia is reduced in~     people habitually consuming high flavonoid intakes, but data from human intervention studies~     is sparse. We therefore investigated whether 12 weeks of blueberry concentrate~     supplementation improved cognitive function in healthy elderly via increased brain activation~     and perfusion.~   "
44405|NCT02985567|"~     The study involves a prospective evaluation of chloral hydrate sedation for the measurement~     of intraocular pressure in children ages one month to five years of age.~   "
44406|NCT02985554|"~     This is an open-label, dose escalation Phase I study to evaluate the tolerability and~     efficacy of single agent of Nivolumab as maintenance treatment to prevent relapse in patients~     with hematologic malignancies after allogeneic stem cell transplantation. Approximately 29~     patients will be enrolled, where about 6-12 patients will be included on the dose escalation~     phase and 20 patients will be on the expansion cohort at maximal tolerated dose.~   "
44407|NCT02985541|"~     The study is performed to assess if Mirena is effective and safe as a birth control method~     beyond 5 years of use. Further the menstrual blood loss (in women that had Mirena inserted~     for the indication heavy menstrual bleeding [HMB]) and safety will be assessed.~   "
44408|NCT02985528|"~     Clinical risk assessment and management is mostly relevant in emergency. Thoracic ultrasound~     (TUS) has been proposed as an easy-option replacement for chest X-ray (CXR) in Emergency~     diagnosis of pneumonia, pleural effusion and pneumothorax. Investigators investigated CXR~     unforeseen diagnosis, provided by TUS, exploring usefulness and sustainability of~     telementoring aimed at the management of clinical risk. This observational report includes a~     period of six months with a proactive concurrent adjunctive telementoring in TUS diagnosis~     using freely available smartphone applications for the transfer of images and movies.~   "
44409|NCT02985515|"~     The purpose of this research study is to determine if budesonide nasal saline irrigation or~     smell training intervention impact sense of smell.~   "
44928|NCT02978755|"~     First in human study, assessing the safety profile, the pharmacokinetics and preliminary~     antitumor activity of GM102, a new compound (a monoclonal antibody), in patients with~     previously treated gynecological cancers bearing the AMHRII (anti-mullerian Hormone Receptor~     II) receptor. The primary objective of the study is to determine the GM102 recommended dose.~   "
44410|NCT02985502|"~     Background: Pancreatogenic diabetes resulted from total pancreatectomy(TP) is one of the~     reason why this form of surgery technique is seldom performed. However, with the progress of~     medical and surgical care nowadays, patients undergone TP could receive better care in~     endocrine and exocrine insufficiency. In addition, with better understanding of benign~     pancreatic tumors and pancreatic neuroendocrine tumors, more patients with diffused~     pancreatic disease are diagnosed; hence, the performance of TP may rise. Nevertheless, the~     quality of life of patients with pancreatogenic diabetes after TP is still currently~     controversial.~      Purpose: The purpose of this study is to (1) explore the association of fatigue, self-care~     activities and quality of life in patients with pancreatogenic diabetes after total~     pancreatectomy; (2) compare the data with diabetic patients after pancreaticoduodenectomy.~      Method: A correlational and comparative cross-sectional approach will be used. The data will~     be collected with a structured questionnaire via purposive sampling of 120 subjects in an~     outpatient pancreatic surgical department. Inclusion criteria will be the patients with: (1)~     age 20 or above, (2) conscious clear, can communicate in Mandarin or Taiwanese, (3) agree to~     participate in the study and sign informed consent. Exclusion criteria will be the patients~     diagnosed with cancer other than pancreatic cancer and under active treatment. Data will go~     through propensity score matching and will be analyzed by using descriptive statistics,~     paired t-test, Chi square test, Pearson's correlation, and conditional logistic regression.~      Anticipated achievement: The anticipated achievement of this study is to understand the~     relationships between fatigue, self-care activities, and quality of life in patients with~     pancreatogenic diabetes after pancreas surgery. In addition, through this study, the~     influence of diabetes to patients after pancreatic tumor resection can be explored; and the~     factors that influence the population's quality of life can be examined. By the filling of~     this knowledge gap, intervention can be planned accordingly to help improve the population's~     quality of life.~   "
44411|NCT02985489|"~     Malnourished patients with IBD that receive pre-operative parenteral nutrition therapy will~     have fewer post-operative complications compared to malnourished patients that receive~     standard of care nutritional therapy.~   "
44412|NCT02985476|"~     This study evaluated the extent to which a shared health record facilitated better~     communication, increase individual responsibility for health care and reduce demand for~     health resources.~      The study made individualised reports available to patients and General Practitioners and~     gave much more detail about participants chronic disease and treatments, and evaluated its~     effectiveness in a randomised controlled feasibility trial.~      One third of patients received care as usual, two thirds of patients received the~     intervention.~   "
44413|NCT02985463|"~     Left Atrial Appendage Occlusion and Biomarker Evaluation (LABEL) is a single-center,~     prospective and observational study evaluating changes of the expression of biomarkers in~     eligible patients before and after percutaneous implantation of a left atrial appendage (LAA)~     occlusion device at mid-term follow-up.~   "
44414|NCT02985450|"~     (1) Due to missed childhood vaccination programs, the majority of adult patients with NAFLD~     in Canada do not have immunity to hepatitis B. (2) Adults with NAFLD who receive the HBV~     vaccine have reduced immunogenic responses in the setting of obesity (i.e., protective~     anti-HBs titres). Aims: (1) To determine the sero-prevalence of immunity against hepatitis B~     in a cohort of prospectively evaluated adult NAFLD patients. (2) To prospectively determine~     HBV vaccine responses (anti-HBs titres) in adult NAFLD patients.~   "
44415|NCT02985437|"~     Bovine Lung Surfactant is used as standard therapy for reducing alveolar surface tension in~     preterm infants. Here the drug is administered via airways.~      The use on skin to stimulate the wound healing has not yet been tested in humans, i.e. it is~     not yet approved for the treatment of wound healing disorders. In the planned clinical trial~     Lung Surfactant is used the first time for the local treatment of skin lesions in humans. No~     substance related side effects were observed during the application via airways in neonates.~      The innovative idea to use lung surfactant for skin wound healing derived from two~     observations. First, when the skin is injured, the barrier protecting the moist body surface~     from the dry environment is discontinued and in part lost.~      Lung surfactant has several characteristics that might be beneficial for treatment of chronic~     cutaneous wounds.~   "
44416|NCT02985424|"~     The purpose of this study is to delineate the association of the 18F-Fluorodeoxyglucose~     Positron Emission Tomography/Computed Tomography (18F-FDG PET/CT) detected vasculitis pattern~     of the large vessels (PET positivity) and the clinical picture of Polymyalgia Rheumatica~     (PMR)/Giant Cell Arteritis (GCA) .~   "
44417|NCT02985411|"~     Gardening interventions yield a multitude of measurable benefits that are evaluable within~     the context of a clinical trial. Harvest for Health forges new inroads in the delivery of~     holistic interventions to high risk populations, in this case, older cancer survivors. Since~     the intervention banks on an existing organization's infrastructure, it can easily be~     disseminated nationwide. The next step is to prove efficacy - an essential step in~     contributing to the science in this area, and one which is crucial for future dissemination.~   "
44418|NCT02985398|"~     An evaluation of long term safety of repeat ALD403 doses in Chronic Migraine~   "
44419|NCT02985385|"~     To prove that palliative therapy can be practised for congenital lethal malformations within~     the Islamic Code of Ethics.~      After defining lethal malformation no respiratory support is offered and newborns are~     provided with compassionate care.~   "
44420|NCT02985372|"~     This prospective multicenter clinical study was designed to assess the efficacy and safety of~     decitabine in combination with low-dose cytarabine induction treatment for elderly patients~     with newly diagnosed acute myeloid leukemia (AML).~   "
44421|NCT02985359|"~     The goal of this evaluation is to assess the impact of a 3.5 year, World Food Program (WFP)~     supplemental child feeding and nutrition services program in reducing stunting and improving~     linear growth in children from 6 through 24 months of age in a rural district of Malawi.~   "
44422|NCT02985346|"~     Pulmonary hemosiderosis (PH) is a pulmonary hemosiderin deposition which caused by alveolar~     capillary hemorrhage. PH is easy to recurrent and can lead to pulmonary fibrosis and~     insufficiency if the disease was poor controlled. Steroid is the most common drug that was~     administered in acute phase of the disease. However, considered the side-effects, steroid is~     not suitable for long-time maintenance. Therefore, it is necessary to explore a new therapy.~     Bone marrow mesenchymal stem cells (BMSC) are a kind of adult stem cells with high~     self-renewal and multi-directional differentiation potential in bone marrow. It has become a~     hot topic in immunosuppressive and tissue repair therapy in recent years. To date, homing,~     colonization and differentiation of BMSCs in the lung have been observed in animal models of~     pulmonary hypertension, radiation pneumonitis and pulmonary fibrosis. It had been reported~     that BMSC transplantation in acute lung injury in mice, inflammation of lung injury can~     significantly improve. The aim of this study is to explore the effect of BMSC on PH and its~     mechanism, and to explore a new way to promote the repair of IPH. It is expected to improve~     the status of IPH therapy in children, especially improve the prognosis of refractory PH.~   "
44425|NCT02985307|"~     This study evaluates the efficacy of a mobile telehealth short message service as a~     facilitator for weight management. Half of the participants will receive a standard care~     weight management group intervention, while the other half will receive daily text messages~     via their mobile phone to help facilitate weight loss. It is hypothesized that the~     intervention group receiving text messages will be as successful as the control group at~     achieving weight loss over a 3-month period.~   "
44426|NCT02985294|"~     This study evaluates peripheral nervous system function using Multiple Excitability Measures~     (MEM) to obtain electrophysiological pain phenotypes~   "
44427|NCT02985281|"~     Evaluation of Safety and Efficacy of Gratisovir (Sofosbuvir)- Ribavirin Therapy in Egyptian~     Pediatric Patients With Chronic Hepatitis C Infection aged 10- 18 years old.~   "
44428|NCT02985268|"~     At present, the optimal treatment strategy for heart failure patients and moderate-to-severe~     (3+) or severe (4+) mitral regurgitation with a class IIa recommendation for CRT is~     uncertain.Whether these patents should also be treated for functional mitral regurgitation or~     with CRT also remains unclear. We therefore propose a randomized 2x2 factorial design in this~     patient population to understand the the impact of both CRT and transcatheter mitral valve~     repair with the MitraClip on their functional status and quality of life.~   "
44429|NCT02985255|"~     Patients enrolled for the study, who are eligible for NACT, will undergo a pre-treatment~     workup comprising of Evaluation Under Anesthesia (EUA) for tumor Mapping and tissue biopsy~     along with a PET-CT scan. Subsequently, they would undergo 3 cycles of NACT (weekly thrice)~     with DCF. They would be reassessed with PET-CT and EUA +/- biopsy after the end of the third~     cycle. Those who are achieving CR would undergo adjuvant CTRT. Subjects who have a PR in the~     PET-CT scan will be re-classified based on the biopsy report. If they remain in the PR group~     they will undergo surgery but if the biopsy in is negative for malignancy, they will undergo~     adjuvant CTRT. Those subjects with SD or PD would undergo surgery. Subsequently, further~     radiation and/ or chemotherapy will be decided based on the final histopathology (of the~     surgical specimen) reports.~      PET-CT and EUA +/- HPE analyses would be repeated on follow-up after 3 months of treatment~     completion.~   "
44430|NCT02985242|"~     This is a prospective, randomized, active control, two-arm parallel, double-blind, monocenter~     phase IV clinical trial. The trial compares empagliflozin to glimepiride in patients with~     type 2 diabetes mellitus in addition to standard of care treatment.~      Patients with type 2 diabetes mellitus who are between 18 and 80 years of age will be~     recruited for the clinical trial and randomly allocated to either receive empagliflozin or~     glimepiride.~      The assumption of the study is that empagliflozin slows down diabetic retinopathy progression~     rate and thus a lower microaneurysm formation rate compared to subjects treated with~     glimepiride by substantially decreased cellular glucotoxicity will be achieved.~   "
44431|NCT02985229|"~     To test the hypothesis that a regimen of 200 mg oral mifepristone, with the option of home~     administration, followed by 800 μg buccal misoprostol 24 hours later for abortion through 70~     days LMP will be feasible and acceptable in Singapore.~   "
44432|NCT02985216|"~     A Randomized, Double-blind, Active-Controlled, Multi-center, Phase 3 Trial to Compare the~     Safety and Efficacy between YHD1119 and Pregabalin in Patients with Peripheral Neuropathic~     Pain~   "
44433|NCT02985203|"~     This is an open-label, multi-center clinical trial, aims to evaluate the efficacy and safety~     of combination of oral Navelbine and Cisplatin followed by metronomic oral Navelbine in~     Patients with advanced Non-Small Cell Lung Cancer.~      The study comprises two stages. In the 1st stage (Week 1-12), all patients will receive~     combination chemotherapy. In the 2nd stage (Week 13-25), patients who complete the~     combination chemotherapy with acceptable tolerance and have no progressive disease (PD) will~     be allocated into 2 arms, to evaluate the efficacy and safety of maintenance chemotherapy~     with metronomic oral Navelbine (Arm A) or other regimen (Arm B).~   "
44434|NCT02985190|"~     This study is a phase II of effcicacy and tolerance of azacitidine in patients with~     myelodysplatic syndrome and steroid dependent or resistent systemic auto-immune and~     inflammatory disorders~   "
44435|NCT02985177|"~     MSK-I is the most common cause for ED visits for children with pain, with a child's risk of~     sustaining a fracture ranging from 27-42% by the age of 16 years. MSK-I is known to generate~     moderate to severe pain in most children and the ED serves as the critical entry point for~     these injured children. This study aims to provide rapid and sustained pain management for~     children presenting with a MSK-I in the ED. The investigators will compare the efficacy of 2~     possible medication combinations (fentanyl intranasal + oral hydromorphone or fentanyl~     intranasal + oral ibuprofen) for the rapid, adequate and sustained pain management of~     children with suspected fracture.~      The investigators believe that the addition of HM to INF will lead to better pain treatment~     by providing a consistent and adequate level of analgesia throughout the entire ED visit,~     including prior to physician exam and during painful radiologic procedures.~   "
44436|NCT02985164|"~     Radiation now becomes a dreadful effect as its outcomes are tremendous to be expected. As a~     result, anesthetists become an inevitable target to the radiation exposure since they have to~     monitor patients closely during the operation. Unfortunately, radiation may not have an~     immediate sequelae, but an accumulation of adverse effects.~      These sequelae happen by means of direct exposure and reflection. The reflected rays is~     inversely proportional to the distance between the origin and the target. Practically, the~     radiation source can be protected by individual cover and glass shield.~      Siriraj hospital is a tertiary, general university hospital with 2,200 beds. Annually, an~     Endoscopy centre has over 700 patients undergoing endoscopic retrograde cholangio~     pancreaticography (ERCP). Normally, fluoroscopy for pancreatic and biliary ducts~     visualisation is needed under anesthesia. Though the procedure is operated in a~     well-equipped, radiating-protection room; many medical personnel including 1-2 endoscopists,~     2 scrub nurses, 1-2 anesthetists and 1 x-ray man, still have a chance of irradiation.~      During ERCP, all medical personnel particularly anesthetists are rinsed by radiation from~     here and there. Though they always wear lead aprons and collar shields to protect themselves~     from the rays, they are normally in the position - less than 1 meter - close to the~     fluoroscopy.~      Due to the advancement in technology, anesthetists can remotely monitor patients during the~     surgical procedure. This might cause a lesser effect of ray upon them. As a result, whether~     or not the positioning of anesthesia personnel relating to the distance of x-ray source would~     help to alleviate the effect of radiation exposure.~   "
44437|NCT02985151|"~     This study evaluates the effect of a fractionated carbon dioxide laser on surgical scars of~     the face and neck over 12 months. Anyone with a surgical scar on the face and neck who has~     not had laser therapy may be eligible to participate. The visits occur every three months for~     up to 12 months. Subjects will be randomly assigned to receive a higher energy treatment or a~     lower energy treatment during the study. Subjects and raters will be blinded to which therapy~     level the patient receives. At each visit, the scars will be photographed and the subject~     will complete a questionnaire to rate the scar prior to treatment. Three physicians will~     evaluate the scar at each visit. One rater will evaluate the scars in person during the~     visit, while the other two raters will evaluate the scars using photographs after each visit.~     During the first three study visits, subjects will receive their assigned treatment, obtain~     post-treatment instructions, and a diary to record redness, swelling, pain, itching, or other~     skin changes after treatment. At the third study visit, subjects will have the option to~     receive additional treatments or terminate their participation in the study. The fourth visit~     for those who continue will be a treatment visit for one group and the fifth visit will be~     for data collection, with no treatment offered.~   "
44438|NCT02985138|"~     TLIF is a popular lumbar interbody fusion technique to perform anterior interbody fusion.~     Pedicle screws providing initial stability have been developed to correct deformity, improve~     the rate of fusion and speed patient's postoperative recovery. Conventionally, an open~     approach is required, using bilateral pedicle screw fixation to provide stability as the gold~     standard. However, the increased stiffness of the fused segments will reduce the bone mineral~     content in adjacent vertebrae, and biomechanical studies have indicated that increased stress~     at the levels adjacent to the fusion may increase adjacent segment pathology. Therefore,~     unilateral pedicle screw fixation had been considered as a means to decrease the stiffness of~     the instrumented segment. Recently, researchers have shown that unilateral instrumented~     spinal fusion provides comparable results and is as effective as bilateral fixation. In~     addition, the cost-effectiveness of this approach is worthy of attention. To our knowledge,~     few randomized controlled studies comparing unilateral versus bilateral instrumented TLIF in~     lumbar degenerative diseases have been reported. The purpose of this study is to compare~     clinical and radiographic outcomes in a series of patients with lumbar degenerative diseases~     using instrumented TLIF with unilateral or bilateral pedicle screw fixation.~   "
44439|NCT02985125|"~     This study is a single-arm, open-label, multi-institutional Phase I/II trial of the~     combination of LEE011 and everolimus in refractory mPAC.~   "
44440|NCT02985112|"~     Revascularization of borderline coronary stenoses (40-70%) is usually driven by fractional~     flow reserve (FFR) which expresses the physiological significance of a lesion and tells the~     operator whether PCI may reduce the rate of adverse events as compared to medical therapy.~     Coronary stenoses with FFR value < 0.80 are indeed associated with a higher rate of adverse~     event and requires coronary revascularization whereas lesions with FFR > 0.80 show an~     excellent prognosis which cannot be improved by coronary stenting. Such a predictive value of~     FFR is theoretically based only on the degree of myocardial ischemia downstream from a given~     coronary stenosis: however, also plaque composition may play a crucial role in triggering~     future events especially in patients affected by acute coronary syndrome. Differences in~     plaque composition between FFR-positive and FFR negative lesions have never been assessed.~     Intracoronary Near-InfraRed Spectroscopy (NIRS) identifies lipid rich plaques that can~     potentially cause acute events. The aim of this study is to compare the lipid content~     expressed by LCBI (Lipid Core Burden Index) between functionally significant (FFR < 0.80) and~     non-significant (FFR > 0.80) stenoses in patients undergoing coronary angiography because of~     stable CAD and non-ST elevation acute coronary syndromes. This is an observational,~     prospective, multicentric study where we plan to collect 150 coronary lesions.~   "
44441|NCT02985099|"~     The purpose of the present study was to evaluate the effects of subgingival delivery of 1.2%~     Rosuvastatin (RSV) gel as an adjunct to scaling and root planing in chronic periodontitis~     (CP) with Type 2 diabetes mellitus patients.~   "
44442|NCT02985086|"~     The primary aim of this study is to determine if antibiotics combined with immediate~     induction can significantly reduce the rate of maternal and neonatal infection compared with~     immediate induction alone in women presenting with PROM later than the 37+0 weeks of~     gestation. The secondary aim is to compare the rates of infection between immediate and~     delayed induction in women submitted to antibiotic prophylaxis.~   "
44443|NCT02985073|"~     This study compares the outcome using a biological mesh (Veritas®) compared to a non~     biological mesh (TIGR®) in immediate breast reconstruction.~   "
44444|NCT02985060|"~     To study safety and feasibility of mild therapeutic hypothermia after successful~     recanalization by mechanical endovascular treatment in patients with acute ischemic stroke~     and proximal arterial occlusion.~   "
44445|NCT02985047|"~     The purpose of the study is to test a standardized version of brief admission (BA) through~     randomized controlled trial (RCT). The main objective is to evaluate if BA can serve as a~     crisis management model for individuals with recurrent self-harm, including suicide attempts~     and at least three symptoms of Borderline Personality disorder. Participants will be~     allocated to BA + Treatment as Usual (TAU) or TAU.~   "
44446|NCT02985034|"~     Magnetic resonance imaging (MRI) has been widely used for small liver lesion detection and~     characterization. In patients who undergo RFA, MRI is often performed before RFA, whereas~     immediate technical success is usually assessed by CT. Conventional visual assessment of two~     modalities may be more challenging than being anticipated, because acquisition position,~     respiration, and spatial resolution differ between the two. Therefore, the study purpose is~     to evaluate the results of software-assisted ablative margin assessment using registration of~     different pre-and post-RFA modalities compared with the conventional method of side-by-side~     MRI-CT comparison in patients with HCCs.~   "
44447|NCT02985021|"~     In this study, patients who have metastatic prostate cancer that does not respond to hormone~     treatment and who have mutations in certain cancer-related genes will be treated with~     docetaxel and carboplatin chemotherapy.~   "
44448|NCT02985008|"~     Retrospectively and prospectively enrolled patients with cardiogenic shock in domestic~     manifolds and investigated the current state of treatment and clinical features of~     cardiogenic shock in Koreans and identified the factors that could improve the prognosis and~     the use of IABP and ECMO And to investigate its therapeutic effect.~   "
44450|NCT02984982|"~     Primary Objective:~      To compare the efficacy of alirocumab with standard of care on coronary atheroma progression~     in patients who have experienced an acute coronary syndrome (ACS) event and are treated with~     atorvastatin or rosuvastatin.~      Secondary Objectives:~        -  To compare the efficacy of alirocumab with standard of care on absolute change in~          percent atheroma volume (PAV) and normalized total atheroma volume (TAV).~        -  To evaluate the efficacy of alirocumab on low-density lipoprotein cholesterol (LDL-C),~          apolipoprotein B (Apo-B), triglycerides, non-high-density lipoprotein cholesterol~          (non-HDL-C) and Lipoprotein(a)(Lp[a]).~        -  To evaluate the safety of alirocumab including the occurrence of cardiovascular events~          (coronary heart disease [CHD] death, non-fatal myocardial infarction [MI], fatal and~          non-fatal ischemic stroke, unstable angina requiring hospitalization).~   "
44451|NCT02984969|"~     Constipation is a frequent, chronic gastroenterological problem that has many varied symptoms~     and thus has several clinical definitions. According to the Rome III criteria for chronic~     constipation, almost 16% of all adults are affected by chronic constipation worldwide, and it~     is more prevalent and symptomatic in women and elderly people. Slow transit constipation~     (STC) is the major category and is characterized by a decreased rate of colonic transit.~      Recently, many researchers have focused on the relationship between intestinal microbiota and~     constipation and have demonstrated that intestinal microbiota contribute to the~     pathophysiology of functional gastrointestinal disorders.~      Thus, there is a need for an improved understanding of gut microbiota composition in~     constipation patients and for the potential role played by the gut microbiota in the etiology~     of STC.To achieve this goal the investigators characterized and compared the intestinal~     microbiota among carefully selected patients with constipation that were clinically~     categorized based on Rome III criteria, and healthy controls using high throughput~     pyrosequencing of the 16S rRNA gene and a conservative approach to detect quantitative~     changes in the relative abundances of taxa.~   "
44452|NCT02984956|"~     Correct assessment of a patient's volume status is the most important goal for an~     anesthetist. However, most of the variables used for fluid response evaluation are invasive~     and technically challenging.Pulse oximeter is a non-invasive, standardized and widely used~     monitoring method in many countries. Our aim in this study is to investigate the usefulness~     of the noninvasive pleth variability index to predict hypotension in orthopedic hip fracture~     patients who underwent spinal anesthesia.~   "
44453|NCT02984943|"~     The purpose of this investigation is to determine the effects and ease of using hyperbaric~     oxygen therapy HBO2 for the treatment of rheumatoid arthritis joint pain and prevention of~     disease progression. In this study it is our intention to not only evaluate effects and ease~     of treatment but time, cost, possible adverse events and effect size in an attempt to predict~     an appropriate sample size and improve on the study design prior to a more extensive study.~   "
44454|NCT02984930|"~     The gastric acid pocket is believed to be the reservoir from which acid reflux events~     originate. The risk for acidic reflux is mainly determined by the position of the gastric~     acid pocket. Little is known about how changes in position and size of the acid pocket~     contribute to the therapeutic effect of proton pump inhibitors(PPI) plus mosapride in~     patients with gastroesophageal reflux disease. Investigators will conduct a prospective~     randomized, single blind and placebo-controlled clinical trial to evaluate the hypothesis~     that mosapride affecting gastric motility might reduce gastro-esophageal reflux by changing~     the acid pocket position and size.~   "
44455|NCT02984917|"~     To investigate the advantages and disadvantages of the anterior transversalis fascia approach~     versus the preperitoneal approach for inguinal hernia repair in residents from northern China~     regarding common postoperative complications (including acute and chronic pain, wound~     infection, rates of wound infection, hematoma, seroma, and hernia recurrence) and severe~     postoperative complications.~   "
44456|NCT02984904|"~     The aim of this study was to describe the clinical-epidemiological characteristics of a~     series of cases of fungal keratitis associated with Fusarium spp., In Spain during the years~     2012 to 2014.~   "
44457|NCT02984891|"~     Both intravascular ultrasound (IVUS) and optical coherence tomography (OCT) are standardly~     used and have been extensively studied separately to guide percutaneous coronary intervention~     and improve long-term outcomes. In this study, the investigators aim to directly compare~     high-definition IVUS images to OCT in the same patients to determine the differences between~     each modality as they relate to imaging coronary pathology, with the goal of determining~     which modality is most appropriate in particular clinical scenarios.~   "
44458|NCT02984878|"~     To compare improvement with retreatment for all subjects undergoing correction of nasolabial~     folds (NLFs) in the initial SYM2014-02 study, who were retreated with Revanesse Ultra at~     Visit 6/Week 24 and to determine the safety of repeat injections of Revanesse Ultra. The~     retreatment phase was optional.~   "
44459|NCT02984865|"~     Peritoneal dialysis (PD) catheter placement surgery for patients with end-stage renal disease~     (ESRD) can be performed under peripheral nerve block. This study assessed the ability of~     ultrasound guided left lateral transversus abdominis plane (TAP) block combined with rectus~     sheath (RS) block in PD catheter placement surgery. Also, surgeries are common surgeries~     performed in elderly patients throughout the world. Although there is an increasing trend~     towards laparoscopic surgeries, open procedures continue to remain common therapeutic~     modalities especially in the developing countries. Pain is reported more commonly in patients~     undergoing open procedures than laparoscopic procedures. Postoperative pain and tissue injury~     associated with surgery initiated a systemic stress response which has neuroendocrine,~     immunological, and haematological responses. Opioids are an important modality of~     postoperative pain management. They blunt the neuroendocrine stress response to pain.~     However, they are associated with several adverse effects like respiratory depression,~     nausea, vomiting , pruritus, constipation, urinary retension, bradycardia and hypotension.~     Transversus abdominis plane block（TAPB）is a relative novel procedure in which local~     anesthetic agents are injected into the anatomic plane between the internal oblique and the~     transversus abdominis muscle. It allows a significantly prolonged duration of analgesia~     during the early postoperative stage in abdominal surgery. This regional anesthesia technique~     provides analgesia to the skin, muscles of the anterior abdominal wall and parietal~     peritoneum in order to decrease the incision-related pain. Thus, it reduces postoperative~     opiate requirements and opioids-related side effects (nausea, vomiting, delayed resumption of~     intestinal transit, drowsiness, respiratory depression, urine retention). Nalbuphine, being~     mu antagonist an kappa agonist, has a ceiling effect in its respiratory depression. Many~     studies have reported that incidence of adverse effects like pruritus and PONV is lower with~     nalbuphine in comparison with morphine. The purpose of this study is to compare the analgesic~     efficacy and side effect profile of sulfentanyl with nalbuphine in elderly patients~     undergoing open gastrointestinal surgeries.~   "
45550|NCT02970630|"~     Prospective, single-arm, open-label, multicentre study with the principal aim to estimate~     tacrolimus pharmacokinetic parameters in elderly de-novo kidney transplant recipients of ECD~     (Extended Criteria Donor) kidney grafts treated with Envarsus® prolonged release tablets in~     combination with everolimus tablets.~   "
44460|NCT02984852|"~     The purpose of this study is to evaluate the single-dose pharmacokinetics and relative~     bioavailability of Darunavir (DRV) 800 milligram (mg), Cobicistat (COBI) 150 mg,~     Emtricitabine (FTC) 200 mg, and tenofovir alafenamide (TAF) 10 mg when administered as a~     fixed-dose combination (FDC) (D/C/F/TAF) tablet in healthy adult participants when given as~     Treatment A (reference): a single dose of D/C/F/TAF (800/150/200/10 mg) FDC tablet swallowed~     as a whole, intact tablet with 240milliliter (mL) of noncarbonated water.Treatment B (test):~     a single dose of D/C/F/TAF (800/150/200/10 mg) FDC tablet as a split tablet swallowed with~     240 mL of noncarbonated water. Treatment C (test): a single dose of D/C/F/TAF (800/150/200/10~     mg) FDC tablet as a crushed tablet mixed in 4 ounces (oz) of applesauce.~   "
44461|NCT02984839|"~     The aim of this prospective, observational study is to determine the incidence of~     post-operative residual neuromuscular blockade (PRNB) in patients undergoing intra-abdominal~     procedures compared to patients undergoing other noncardiac/non intra-thoracic procedures~     that also require non-depolarizing neuromuscular blocking agents (NMBA) administration. As~     intra-abdominal surgeries are independently associated with post-operative pulmonary~     complications (PPCs), it is important to highlight other factors, such as PRNB, that could~     contribute to these complications.Although it has been shown that the risk of adverse~     respiratory events can be reduced by intra-operative quantitative neuromuscular monitoring,~     such monitoring is not in widespread use.This study will incorporate quantitative monitoring~     in the post-anesthesia care unit (PACU) setting by using the Stimpod NMS450® in an effort to~     show a disparity in the incidence of residual paralysis between these two patient populations~     and to emphasize the need to implement more accurate neuromuscular monitoring, especially for~     those that are already at increased risk for respiratory complications.~   "
44462|NCT02984826|"~     Background:~      Tension Type Headache (TTH) is highly frequent and is of great socio-economic importance.~     Andersen et al. 2008 has shown that maximal muscle strength is reduced in women with~     trapezius myalgia. It is shown that specific strength training leads to prolonged pain~     relief.~      Aim:Test: To investigate the impact of TTH on shoulder, and neck muscle strength in patients~     with TTH compared to healthy controls.~      Intervention: To investigate the effect of specific strength training on patients with TTH~     compared with control group, receiving training in ergonomics.~      Method: Test part. 60 tension headache patients, 30 healthy. Muscle testing of neck and~     shoulder. Testing conducted by blinded research assistant.~      Intervention group: 60 patients with tension headache randomly assigned to the intervention~     group or control group. Intervention with specific strength training program runs for 10~     weeks. The control group will be trained in ergonomics. 3 months follow up.~   "
44463|NCT02984813|"~     This study is a multi-armed protocol designed to evaluate the safety and efficacy of two~     different combinations of nutritional supplements (study drug) (Glauco-Health and~     Glauco-Select) chosen for their potential to protect retinal ganglion cells against oxidative~     stress, low-grade inflammation, and mitochondrial dysfunction in patients with open-angle~     glaucoma and diabetic retinopathy. Oxidative stress and retinal cellular dysfunction will be~     measured using a Retinal Metabolic Analyzer (RMA) in this randomized, single center, double~     masked study. Patients with glaucoma will be divided into three treatment arms randomized to~     receive either Glauco-Health, Glauco-Select, or placebo.~   "
44464|NCT02984800|"~     Paravertebral block (PVB) might be a technique of choice for hernia surgery due to its~     unilateral segmental anesthesia of the operative site, good muscle relaxation and prolonged~     postoperative analgesia. Despite PVB effectiveness, a continuing search for a reliable,~     timely and effective technique generates the investigation of a single PVB injection for~     children undergoing unilateral inguinal hernia repair. Two theoretical concepts were behind~     this investigation. First, possible spread of single PVB injection in the lumbar area over~     dermatomes corresponding to the inguinal hernia region in children likewise the spread over~     multiple adjacent segments from a single thoracic PVB injection. Second, as the inguinal~     region receives innervation from the ilioinguinal, iliohypogastric and genitofemoral nerves,~     all three arising from L1-L2 level; thus, a single PVB injection at this level could provide~     unilateral segmental anesthesia.~   "
44465|NCT02984787|"~     The investigators will perform a prospective randomized comparison between 3D and 2D~     laparoscopic total gastrectomy with splenic hilum lymph nodes dissection.~   "
44466|NCT02984774|"~     The goal of the study was the detection of telomerase activity in eutopic, ectopic~     endometrial tissue and in peripheral blood and finding the correlation between the telomerase~     activity and clinic findings. With these results, confirmation of the hypothesis regarding~     the endometriosis pathogenesis and endometriosis-related infertility was aimed.~   "
44467|NCT02984761|"~     Patients with stage I non-small cell lung cancer have been historically treated with surgery~     whenever they are fit for an operation. However, an alternative treatment known as~     stereotactic radiotherapy now appears to offer an equally effective alternative. Doctors~     believe both are good treatments and are therefore conducting this study to determine if one~     may be possibly better than the other.~   "
44468|NCT02984748|"~     The ability to predict post-operative outcomes after implantation is important for a number~     of reasons, including being able to advise candidates of appropriate expectations using~     evidence based guidance. The approved study involves investigation of the ability to predict~     outcomes in the implanted ear alone and in the best-aided binaural listening conditions,~     examining a number of measured factors both pre-, peri- and post-operatively. The study~     incorporates a range of functional outcome measures through questionnaires to ascertain~     social, functional and demographic factors that may be predictive of outcomes. Questionnaires~     are also administered to determine the degree of benefit obtained after implantation for each~     individual, since this forms a key component of providing pre-operative counselling to~     candidates.~   "
44469|NCT02984735|"~     The purpose of this study is to determine the association between gross motor function and~     chewing performance level in children with cerebral palsy (CP). A cross-sectional study was~     conducted in 152 children (ages 2-10y, 51.3% male) with a diagnosis of spastic CP. The Gross~     Motor Function Classification System (GMFCS) was used to determine gross motor function~     levels of children. Chewing performance level was determined by using the Karaduman Chewing~     Performance Scale (KCPS).~   "
44471|NCT02984709|"~     The treatment regimen for type 1 diabetes is complex and demanding, and many adolescents have~     problems with adherence. The proposed study will pilot test a positive psychology~     intervention for adolescents with type 1 diabetes aimed at improving adherence to treatment~     based on feedback from the first iteration of the intervention. The potential benefits~     include helping adolescents achieve better glycemic control, thereby reducing the health~     risks and complications associated with diabetes.~   "
44472|NCT02984696|"~     The aim of our study is to investigate the effects of 6 months oh HRT on total anti-oxidant~     capacity, clinical, endocrine and metabolic features in women affected by hypotalamic~     amenorrhea. The study group included 20 patients treated with 1 mg of transdermal estradiol~     daily and 10mg of oral Medroxyprogesterone acetate from 16th to 24th day of therapy for six~     months. Menstrual pattern, anthropometric parameters, hormonal assays, DXA and bone~     metabolism parameters are evaluated before and after therapy.~   "
44473|NCT02984683|"~     Primary Objective:~      To select in the first part the SAR566658 dose based on Objective Response Rate (ORR) and~     safety of 2 dose levels and to demonstrate in the second part the efficacy of the selected~     dose based on ORR.~      Secondary Objectives:~        -  To assess:~        -  Disease Control Rate (DCR), Duration Of Response (DOR), Progression-Free Survival (PFS),~          and Time To Progression (TTP)~        -  The impact of ocular primary prophylaxis on the incidence of keratopathies;~        -  The potential immunogenicity of SAR566658~        -  To evaluate the global safety profile~   "
44474|NCT02984670|"~     The overall purpose with this investigation is to further our knowledge about cognitive~     behavioral therapy (CBT) for insomnia by examining treatment components, mediators, and~     moderators. The first aim that will be addressed is to explore the efficacy of the CBT~     components with a dismantling-treatment strategy. Two active CBT interventions, intended to~     define its components - cognitive therapy and behavior therapy - will be compared with one~     another as well as with a waitlist condition on a broad range of outcomes at five to nine~     assessment points depending on the measures. The design will thus enable us to examine what~     CBT component or components are necessary, sufficient and facilitative of therapeutic change.~     The second aim that will be explored is to investigate what processes occur in CBT that may~     contribute to treatment outcome with a treatment-mediator strategy. To examine mediators for~     CBT, the following mediators will be assessed; Anxiety and Preoccupation about sleep~     Questionnaire (APSQ), Dysfunctional Beliefs and Attitudes about Sleep (DBAS), Sleep~     Associated Monitoring Index (SAMI), Sleep-Related Behavior Questionnaire (SRBQ), time in bed,~     napping, bedtime variability, and rise time variability. The hypothesis is that cognitive~     processes will mediate cognitive therapy outcomes, and that behavioral factors will have a~     mediating role for behavior therapy improvements. The third aim that will be addressed is to~     examine what patient characteristics does CBT depend on to be effective with a~     treatment-moderator strategy. To investigate moderators for CBT, the following moderators~     will be assessed; age, gender, occupational status, level of education, initial insomnia~     severity, dysfunction, medication use, chronic pain, psychiatric co-morbidity, medical~     co-morbidity, behavioral and cognitive processes used as mediators will also be employed as~     moderators.~   "
44475|NCT02984657|"~     The purpose of this study is to investigate whether intraoperative reverse Trendelenburg~     positioning decreases postoperative hypoxemia and perioperative pulmonary aspiration rates.~   "
44476|NCT02984644|"~     To determine the role of plasma glucagon and insulin in the rise of endogenous glucose~     production (EGP) following the SGLT2 inhibition.~   "
44477|NCT02984631|"~     In patients with heart failure, elevated filling pressures may contribute to symptoms while~     not improving cardiac output. The current study is focused on evaluating the relationship~     between exercise capacity, pulmonary pressures, cardiopulmonary parameters, and symptoms of~     dyspnea in patients with heart failure during exercise.~   "
44478|NCT02984618|"~     Introduction: Recently sphenopalatine block emerged as an alternative to epidural blood patch~     for post dural puncture headache but the investigators do not know if it has significant~     efficacy when compared to epidural blood patch. Method: randomized trial where patients will~     randomly receive either sphenopalatine block or epidural blood patch. Pain relief to no pain~     or low intensity pain will be the main outcome~   "
44479|NCT02984605|"~     This study evaluates the nutritional meal replacement and individualized exercise~     prescription intervention on overweight and obese type 2 diabetes mellitus. Half of~     participants will receive nutritional meal replacement and individualized exercise~     prescription on the basis of conventional glucose-lowering treatment, while the other half~     will only receive conventional glucose-lowering treatment.~   "
44480|NCT02984592|"~     Premature ejaculation (PE) is one of the prevalent disorders in men; its leading sequel such~     as lack of self-confidence, anxiety, depression and unsatisfactory intercourse in men and~     their partners. The current study was aimed to evaluate the relationship between ejaculation~     and physical activity.~   "
44481|NCT02984579|"~     This is a multi-center, blinded study to determine the performance of the YD Diagnostic~     Corporation (YD) REBA MTB-MDR® and Hain Genotype MTBDRplus V2 kit in a total of 600 clinical~     isolates and 900 residual sputum samples from patients with symptoms of pulmonary TB (PTB)~     and at risk of drug resistance. All testing was done on stored, de-identified leftover~     samples.~      The study involved three World Health Organization (WHO) Supranational Reference Laboratories~     with well-characterized strain collections and access to sputum samples with significant~     rates of drug resistance.~   "
44482|NCT02984566|"~     Primary and secondary liver cancer patients will receive liver SABR with or without KIM~     intervention.~   "
44483|NCT02984553|"~     The purpose of this study is to accurately assess weekly physical activity levels of~     postmenopausal women using lactate thresholds to individualize the accelerometer cut-points.~   "
44484|NCT02984540|"~     The purpose of the BEAM study is to compare the effects of a low-carbohydrate diet and a~     lowfat diet for adults with mild memory loss and adults with pre-diabetes. The data collected~     will help determine changes in cognitive function, brain structure and function, and levels~     of certain proteins and hormones in body fluids.~   "
44485|NCT02984527|"~     The Purpose of the study is to compare the effectiveness on microbiological counts from skin~     swaps after wash with water and soap or wet wipes.~   "
44486|NCT02984514|"~     Brown adipose tissue has the capacity to consume large amounts of energy and has~     insulin-independent glucose uptake. The investigators have recently observed an inverse~     correlation between irisin levels and insulin needs of type 1 diabetes patients.~     Transplantation of brown adipose tissue to insulin-deficient rats normalized their blood~     glucose levels.~      In this study 12 patients with long-standing type 1 diabetes (>10 years) and with variable~     exogenous insulin needs will be investigated for amount of brown adipose tissue with positron~     emission tomography using the tracer 18F-deoxy glucose.~   "
45551|NCT02970617|"~     This clinical trial studies how well ringing a bell on the final day of radiation therapy~     works in improving the memory of distress in cancer patients. Ringing a bell on the final day~     of radiation therapy may improve the memory of how painful the treatment was.~   "
44487|NCT02984501|"~     There is no a clear consensus regarding the optimal treatment of locally advanced pancreatic~     disease. There is a potential role for neoadjuvant therapy to treat micrometastatic disease~     with chemotherapy, as well as for the treatment of local disease with radiotherapy. The~     investigators evaluated the safety and efficacy of induction chemotherapy with oxaliplatin~     and gemcitabine followed by a high weekly dose of gemcitabine concurrent to radiation therapy~     in patients with borderline resectable and unresectable locally advanced pancreatic cancer~   "
44488|NCT02984488|"~     To evaluate the incidence and severity of postoperative pain after root canal therapy of~     necrotic teeth in one appointment versus two appointments using Protaper next instrument.~   "
44489|NCT02984475|"~     Beta Thalassemia is a major public health problem in Mediterranean countries.In Egypt, it is~     considered as the most common chronic hemolytic anemia.one of the major complications in this~     inherited disorder is iron overload which lead to oxidative stress and tissue damage.~      Regarding toxic effect of iron overload on liver, hepatomegaly is one of the most findings~     that resulting from hemosiderosis, extra medullary hematopoiesis, transmitted hepatitis B and~     C and cirrhosis.~      A lot of studies have been carried out recently to study the beneficial role of metformin in~     non-diabetic patients of different disorders as non-alcoholic fatty liver disease~     (NAFLD).Among several studies, it's demonstrated that metformin significantly improved~     insulin resistance, aminotransferase levels and liver morphology.~      The role of metformin in these studies is mainly thought to be antioxidant and~     anti-inflammatory effects. However, the role of Metformin on hepatic function in different~     populations with the same mechanism of liver injury should be further investigated.~      This clinical trial will be carried out on 60 patients with beta thalassemia major receiving~     regular blood transfusion and iron chelating therapy, either HCV positive or negative~     patients.~      They will be randomly distributed into either control group (group 1, n=30) receiving blood~     transfusion and taking iron chelating therapy or treatment group (group 2, n=30) receiving~     blood transfusion and taking iron chelating therapy along with metformin tablets (500~     mg/twice daily) for 6 months.~   "
44490|NCT02984462|"~     The study is a prospective randomized study about hallux valgus surgery. The investigator try~     to assess if the fixation of percutaneous Akin osteotomy with a cannulated screw have an~     incidence in the first ray mobility since the two technics ( fixation and no-fixation) are~     described and practiced, and since the stiffness of the first metatarso-phalangeal joint is~     determinant in the result of this functional surgery.~   "
44491|NCT02984449|"~     Rationale:~      Patients undergoing cardiac surgery are at risk of developing perioperative complications and~     major adverse cardiac events, mainly related to both their preoperative status and type of~     surgical procedure. Postoperative exercise based cardiac rehabilitation (CR) is an effective~     therapy to prolong survival and improve quality of life. However, little is known about the~     effect on post-operative complications, quality of life and return to work of a combined pre-~     and post-operative CR program encompassing physical therapy, dietary counseling,~     psychological support and life style management compared to a CR program, which is provided~     only after cardiac surgery.~      Objective:~      to determine whether a pre- and postoperative (PRE+POST) CR program improves the short (up to~     three months) and long term outcomes (up to one year) of the cardiac surgery (i.e. reduction~     in postoperative surgical complications, readmissions to hospital and major adverse cardiac~     events in conjunction with improvements in the physical component of health related quality~     of life), when compared to postoperative CR only (POST).~      Study design:~      A Prospective Randomized Open controlled trial, Blinded End-point. Patients are randomized~     between two standard care CR programs. One group will start a the POST CR program after~     surgery. The other group will be randomized to a combined PRE+POST CR program.~      Study population:~      Patients (age > 18 years) admitted for elective coronary bypass surgery, valve surgery and/or~     aortic surgery~      Main study parameters/endpoints:~      The primary outcome is a composite weighted endpoint of postoperative surgical complications,~     re-admissions to hospital, major adverse cardiac events and health related quality of life~     (two domains: physical functioning and physical problem), at three months and one year after~     surgery. Endpoints are determined by an independent endpoint committee, blinded to the group~     allocation. Secondary, the study focuses on physical health (cardiorespiratory fitness,~     muscle strength and functional status), psychological health (feelings of anxiety and~     depression), work participation, economics, lifestyle risk factors (physical activity and~     smoking behavior), self-efficacy and illness representations.~   "
44492|NCT02984436|"~     This is a prospective observational cohort study of ED patients with acute chest pain or~     other symptoms suggestive of ACS. Blood samples will be collected from study participants for~     High-Sensitivity Cardiac Troponin T (hs-cTnT) analysis. Results from hs-cTnT will be used for~     research purposes only.~      Providers will be blinded to results and participants will be treated by their healthcare~     providers per the standard of care. Participants will have 30 and 90 day phone follow-ups to~     ascertain study outcomes.~   "
44493|NCT02984423|"~     This study aims to answer very important questions regarding the prevalence of somatic and~     germline mutations (sBRCAm and gBRCAm) in a population of newly diagnosed ovarian cancer~     patients from Latin America. These answers may be extremely helpful in the counseling for~     genetic risk and treatment approach in these populations and will aid in making treatment~     decisions in the future~   "
44494|NCT02984410|"~     Oropharyngeal Squamous Cell Carcinoma (OPSCC) arises in the soft palate, tonsils, base of~     tongue, pharyngeal wall, and the vallecula. Most of the patients with early stage OPSCC are~     usually cured. Treatment of early stage OPSCC can be successfully achieved with primary~     surgery including neck dissection, as indicated, or with definitive radiotherapy. The current~     standard treatment for OPSCC is therefore based on either surgery and/or radiotherapy, both~     associated with comparable, high tumor control rates but with different side effects profiles~     and technical constraints.~      In order to decrease the potential morbidity of surgery, transoral approaches have been~     developed within the last decades, including transoral robotic surgery (TORS), transoral~     laser microsurgery (TLM) or conventional transoral techniques. On the other hand, patients~     with head and neck cancer treated with IMRT experienced significant improvements in cause~     specific survival (CSS) compared with patients treated with non-IMRT techniques thus~     suggesting that IMRT may be beneficial in terms of patient's outcomes and toxicity profile.~     It is as yet unclear however, which one of the new techniques is superior to the other in~     terms of function preservation. Given that the functional outcome of most importance is~     swallowing function, the preservation of swallowing is thus of major importance.~      The main objective of the study is to assess and compare the patient-reported swallowing~     function over the first year after randomization to either IMRT or TOS among patients with~     early stage OPSCC.~   "
44495|NCT02984397|"~     Our goal is to conduct a proof-of-concept trial to test the efficacy of KF treatment in~     adolescents with severe CWP not responding to the standard of care (SOC) treatment program in~     a multidisciplinary tertiary care chronic pain clinic. The changes associated to the~     interventions (KF or placebo) will be quantified using the Patients' Global Impression of~     Change (PGIC) scale after 16 weeks of treatment. Secondary, we aim to evaluate the effects of~     KF on the pain sensitivity, physical and emotional functioning, and we will also explore the~     potential biological underlying mechanisms.~   "
44503|NCT02984293|"~     Statins are widely used drugs to treat hypercholesterolaemia. In general, they are very safe~     drugs. However, up to one third of statin users can experience muscle symptoms, which are~     most commonly mild without any conventional laboratory signs of muscle damage. However, these~     muscle symptoms can often lead to poor compliance to the cholesterol-lowering therapy,~     reducing its effectiveness. Recent data has highlighted the potential role of immune system~     in development of statin-induced muscle pain. Variation in the LILRB5 gene has been~     associated with statin intolerance. We aim to investigate the impact of LILRB5 genetic~     variability in tolerability and immune response to atorvastatin in healthy volunteers.~      The study is being undertaken at the Tayside Institute for Cardiovascular Research (TICR) in~     Ninewells Hospital, Dundee. We will recruit participants who have donated a sample to GoSHARE~     study. The participants will be healthy, and recruited according to their genotype of LILRB5~     (information available from GoSHARE). The volunteers will then enter a randomised cross-over~     study with two treatment periods. During treatment period one, all participants will be~     commenced on atorvastatin or placebo (a dummy drug). Before and at the end of the treatment~     period, blood and urine samples will be taken and a muscle symptoms questionnaire will be~     completed to assess the tolerability and immune response to the study drug exposure. After~     four weeks, the study drug is stopped for a washout period of three weeks before cross-over~     commences. Thereafter, during treatment period two, the alternate study drug will be started,~     and tolerability will be assessed similar to that in period one. The study will last~     approximately 11 weeks. The volunteers have a total of 5 visits to the TICR.~   "
44504|NCT02984280|"~     This study will investigate whether there is a population-level association between~     circulating respiratory viruses and NHS hospital admissions for acute vascular events using~     data from national infection surveillance and Hospital Episode Statistics.~   "
44505|NCT02984267|"~     Placement of labor epidurals is a very common daily practice in obstetrical anesthesia.~     Currently, these epidurals are placed based upon palpation of landmarks to determine midline~     and the correct spinal level for placement. Palpation of these landmarks can be difficult,~     however, particularly in morbidly obese patients who have significant amounts of soft tissue~     overlying them. This study seeks to use ultrasound guidance to examine the spine prior to~     epidural placement, and see what effects this has compared to palpation alone with respect to~     procedure time, number of attempts, success rate in the first attempt, failure rate,~     complication rate, patient anxiety levels, and patient satisfaction levels.~   "
44506|NCT02984254|"~     BACKGROUND: Despite the prevalence of patellofemoral ostearthritis (OA), this joint has~     received relatively little attention in the OA literature and there are few treatment options~     for individuals with patellofemoral OA. Patellar misalignment is associated with radiographic~     progression patellofemoral OA and symptoms and in magnetic resonance imaging (MRI), to~     cartilage loss measurements and bone marrow lesions. The hypothesis is that the correction of~     the patella disorder using strategies such as bracing or adhesive bandages can handle the~     symptoms and progression of OA.~      OBJECTIVE: To compare the effect of a brace designed to stabilize the patellofemoral joint~     compared with a neoprene sleeve with kneecap opening in patients with patellofemoral OA.~      METHODS: Fifty-two patients with patellofemoral OA and co-morbidities (Two or more of:~     overweight or obesity, hyperglycemia, dyslipidemia, hyperuricemia, high blood pressure) will~     be divided into two groups according to the knee brace that will receive: Functional Bracing~     patellofemoral (group 1) and neoprene knee sleeve with patella opening (group 2). Both groups~     will be oriented on the clinical treatment of osteoarthritis and metabolic syndrome and asked~     to do daily exercises in addition to reporting the daily consumption of drugs a month before~     placing the orthotics up to three months after placing it. They will be evaluated with the~     questionnaires WOMAC and Lequesne, and asked to perform the five-times-sit-to-stand-test,~     Timed-up-and-go (TUG) and the six-minute walk test in the moments immediately prior to~     placement of the brace, with one, three and after 12 months bracing.~   "
44507|NCT02984241|"~     This study evaluates web-based interventions to help women cope with the stress arising from~     living with a problem-drinking partner~   "
44508|NCT02984228|"~     Glenohumeral osteoarthritis (OA) accounts for approximately 2-5% of all chronic shoulder pain~     and may be classified into primary and secondary forms. Primary glenohumeral OA is caused by~     degenerative joint disease, inflammatory arthropathies, and neuropathic arthropathy secondary~     to syringomyelia or diabetes. Secondary glenohumeral OA is caused by trauma, postoperative~     changes after arthroscopy or capulorraphy, and osteonecrosis. Hyaluronic acid is found in~     synovial joint fluid and has viscoelastic, chondroprotective, and possibly anti-inflammatory~     properties. It has been shown to increase joint lubrication. Platelet-rich plasma contains~     growth factors that have been shown to promote tissue regeneration. The aim of this study is~     to determine whether injections of hyaluronic acid or platelet-rich plasma can be used~     reliably to decrease pain, restore function, and improve quality of life in patients~     suffering from glenohumeral OA. Patients will be randomized to receive either an injection of~     hyaluronic acid or an injection of platelet-rich plasma. Outcomes will be assessed via~     questionnaires for up to 24 weeks post-procedure.~   "
44509|NCT02984215|"~     Plasma-cell post-transplantation lymphoproliferative disorders (PC-PTLD) are rare monomorphic~     PTLD divided into plasma cell myeloma (PCM) and plasmacytoma-like lesion (PLL) PTLD. To date,~     there is no exhaustive published cytogenetic data on PC-PTLD. The investigators report~     array-based comparative genomic hybridization (aCGH) of 10 cases of PCM and PLL-PTLD.~   "
44510|NCT02984202|"~     The objectives of the clinical study are to implant five deaf patients (those with~     Neurofibromatosis Type II, NF2) with a new two-shank auditory midbrain implant array (AMI;~     developed by Cochlear Limited) into the central nucleus of the inferior colliculus in order~     to assess the safety, reliability, consistency of placement, and performance of the AMI~     device. The clinical trial is being performed at Hannover Medical School in Germany in~     collaboration with University of Minnesota (USA) and Cochlear Limited (Australia). The~     clinical trial is being managed by Hannover Clinical Trial Center in Germany.~   "
44511|NCT02984189|"~     Introduction: The inspiratory muscle training (IMT) has showed great benefits to the~     respiratory, autonomic system, and mainly to the improvement of physical performance in~     healthy subjects. The latter is related to the improvement of respiratory muscle strength,~     decreased of dyspnoea, peripheral fatigue and delay in activation of muscle metaboreflex~     during exercise. However, there is no consensus about the best training load to IMT, because~     the prescription has been done only using percentage of the maximal inspiratory pressure~     (MIP), and 60% of MIP has been the most used. Therefore, the IMT prescription protocol that~     takes into account the respiratory muscle strength and endurance can provide additional~     benefits to protocols commonly applied, once that respiratory muscle differs from the other~     muscles due to its greater muscle endurance. In the sense, the IMT using inspiratory critical~     pressure (PThC) comes up with an alternative, since the PThC calculation considers these~     characteristics. Objective:To evaluate the effect of the IMT, using PThC, on cardiovascular,~     respiratory, metabolic and autonomic responses in recreational cyclists and compare it to a~     IMT using 60% of MIP. Methods: Thirty men recreational cyclists (20-40 years), will be~     randomized to placebo group (PG, n = 10), PThC group (PTHCG, n = 10) and 60% of MIP group~     (60G, n = 10), taking into account the age and functional aerobic capacity. All subjects will~     perform the following evaluations: cardiovascular autonomic tests [heart rate variability~     (HRV) and blood pressure variability (BPV) at rest and after active postural change],~     pulmonary function testing, respiratory muscle strength (RMS) test, cardiopulmonary exercise~     testing (CPET), incremental respiratory muscle endurance test (iRME) [maximum respiratory~     pressure sustained for 1 minute (PThMAX)] and constant respiratory loads test (95%, 100% and~     105% of PThMAX), both using an linear inspiratory load resistor (PowerBreathe K5). The PThC~     will be obtained from the linear regression using the time(TLIM) of and load of each constant~     test (95%, 100% and 105% PThMAX). During evaluations, the ECG (BioAmp FE132), blood pressure~     (BP), using Finometer Pro (Finapress Medical Systems) and respiration (Marazza) signals will~     be acquired. The signals will be coupled by data acquisition and analysis device (Power Lab~     8/35) and sampled at 1000 Hz. Moreover, the oxyhemoglobin, deoxyhemoglobin and total~     hemoglobin responses will be measured by near-infrared spectroscopy (NIRS) (Oxymon MKIII),~     sampled at 250Hz. The IMT will be performed for 11 weeks (3 times/week, 1-hour duration). The~     session will consist of 5-min warm-up (50% of the training load) and 3 sets of 15 minutes~     (breathing against 100% of the training load) with 1-min interval between them. Heart rate~     and BP will be monitored in all training sessions. The RMS, iRME, respiratory constant load~     tests and CPET will be performed before and after the training, and in the 3rd and 7th week~     (for training load adjustment). The pulmonary function testing and the cardiovascular~     autonomic tests will be performed only before and after training. The data will be analyzed~     by specific statistical tests (parametric and nonparametric) according to the data~     distribution and their respective variances. Significance will be set at p<0.05. Expected~     results: It is expected that the training performed by PTHCG, when compared to training~     performed by 60G and PG, promotes: greater improvementin workload (Watts) and peak oxygen~     uptake (VO2peak); increasing in MIP and iRME; decreasing of dyspnoea and peripheral fatigue;~     delay in activation of muscle metaboreflex in the CPET and iRME; improvement incardiac~     parasympathetic autonomic modulation and reducing cardiac and peripheral sympathetic~     modulation. Moreover, it is expected that the results can provide information for a better~     understanding of the responses obtained by the PThC training in the different evaluated~     systems. In addition, these results will allow the use of this method by health professionals~     as a new assessment tool and IMT prescription.~   "
44512|NCT02984176|"~     Simethicone is an oral anti-foaming agent that reduces bloating, abdominal discomfort, and~     abdominal pain by promoting the clearance of excessive gas along the gastrointestinal tract.~      The investigators objective is to evaluate the efficacy and safety of preoperative oral~     simethicone for bowel preparation in gynecological laparoscopies.~   "
44513|NCT02984163|"~     The primary purpose of this proposed 5-year hybrid effectiveness and implementation study is~     to evaluate the relative benefit from, and implementation of an Alberta wide~     clinic-to-community-based cancer and exercise model of care - the Alberta Cancer Exercise~     (ACE) Program. The investigators hypothesize that the strategy will improve the physical~     well-being and QoL of survivors (on and off cancer treatment) while preventing the~     development of secondary cancers.~   "
44514|NCT02984150|"~     This study aim to investigate the influence of intragastrically infused fatty acid on the~     generalization of responses to reward within the food domain and between financial and sexual~     domains.~   "
44515|NCT02984137|"~     This is a prospective cohort study to evaluate degenerative changes in the brain by~     performing functional imaging analysis in patients with RBD and its correlations with~     clinical symptoms and dopaminergic degeneration. This study also evaluates cognitive changes~     with functional imaging measures and olfactory and other premotor symptoms of Lewy body~     disease. This study also collects gene extracts and sera to develop a biomarker for early~     detection of neurodegeneration.~   "
44516|NCT02984124|"~     This multicenter RCT of 180 hospitalized patients and their family members evaluates an~     informed assent approach to discussing cardiopulmonary resuscitation, compared to usual~     care, in older seriously ill hospitalized patients with severe life-limiting illness or~     severe functional impairment.~   "
44517|NCT02984111|"~     The aim of this trail is to assess the safety and therapeutic effects of single EPO~     intervention in different times during coronary surgery in changes of inflammatory response.~   "
44518|NCT02984098|"~     The aim of this study was to evaluate the safe of 40% Dextrose oral administration on blood~     glucose concentration and to reducing of pain before painful procedures on healthy term~     neonate 72 hours aged.~   "
44519|NCT02984085|"~     Prospective open-label, uncontrolled clinical study to assess the safety and efficacy of~     autologous cultured epidermal grafts containing epidermal stem cells genetically modified~     with the aid of a gamma-retroviral vector carrying COL7A1 complementary DNA (cDNA) for~     restoration of the epidermis in patients with recessive dystrophic epidermolysis bullosa. The~     purpose of this study is to demonstrate the safety and efficacy after one or more treatments~     with genetically corrected cultured epidermal autograft (Hologene 7) in patients suffering of~     recessive dystrophic epidermolysis bullosa (RDEB) with COL7A1 mutation.~   "
44520|NCT02984072|"~     Topical photodynamic therapy (PDT) is widely used to treat superficial non-melanoma skin~     cancer (NMSC) and dysplasia, notably actinic keratosis and may also be effective in a range~     of other dermatological conditions. A major limitation of PDT is pain during irradiation. A~     lack of knowledge of the mechanism of PDT-induced pain has limited the development of~     effective approaches for prevention or relief of this adverse effect. The investigators have~     investigated the possible efficacy of menthol for PDT pain ex vivo and will now study this in~     a clinical trial. This proposal describes the prospective randomised double blind, placebo~     controlled clinical trial that will be undertaken to investigate the use of topical menthol~     for PDT-induced pain relief in patients with actinic keratosis of the face and scalp who will~     be attending general dermatology and PDT outpatient clinics at Ninewells Hospital, Dundee.~   "
44521|NCT02984059|"~     To characterize persistent abdominal pain in children with inflammatory bowel disease (IBD)~     by examining factors such as disease type, activity and location, psychosocial factors, and~     genetics.~      The investigators hypothesize that by using patient pain and psychological assessments in~     addition to analysis of blood, stool and colonic biopsies, we can better characterize factors~     that predispose children and adolescents with IBD to have persistent and/or disproportionate~     abdominal pain.~   "
44522|NCT02984046|"~     Acute bronchiolitis is a common viral infection in infants mainly due to RSV and rhinovirus.~      Biomarkers can be useful for predicting its severity. The serum CC16 is a marker of~     epithelial aggression. Its rate increase during RSV bronchiolitis in infants less than 7~     months. It could be an early predictive biomarker of the severity of acute bronchiolitis, and~     secondarily for the development of asthma.~      Two other markers of airway aggression seem to increase during acute bronchiolitis: serum~     SP-D protein and serum soluble receptor sRAGE.~   "
44523|NCT02984033|"~     The prospective trial is to describe the quality of life and psychological effects in~     patients with head and neck tumor receiving curative intent treatment~   "
44524|NCT02984020|"~     The objective of this study is to identify any problems and questions with respect to the~     safety and efficacy of Xeljanz during the post-marketing period as required by the regulation~     of MFDS.~   "
44525|NCT02984007|"~     Synopsis: In most countries, there is an increase in the number of parents who refuse some,~     most or all vaccines or who adopt delayed vaccination schedule. Vaccine hesitancy (VH) is a~     global phenomenon that needs to be measured and addressed. However, to this date, no~     effective strategy has been identified. Dr Gagneur have developed and validated a new~     approach to educate parents of newborns about vaccination, based on motivational interviewing~     (MI) techniques. MI is a method to elicit and strengthen motivation for change based on the~     person's own arguments for change that has been shown effective for the adoption of many~     preventive health behaviors. This approach has been validated for vaccination during a pilot~     study as well as in a provincial RCT in Quebec. Now that a proof of concept has been made in~     Quebec, the investigators will validate the approach in other contexts (e.g. English-speaking~     provinces and settings with different ways to deliver maternity care and childhood vaccines).~      Hypothesis: An educational strategy, based on MI techniques, delivered in the maternity ward~     increases parents' intention to vaccinate their infant, reduces VH scores and increases~     infants' vaccine uptake in Quebec. This approach may be applicable across the country in~     order to tackle VH and thus improve infants' vaccine coverage (VC).~      Objective: To evaluate the impact of the MI intervention on parents' intention to vaccinate~     their child and their VH score and on infants' VC at 3 months of age, in a pan-Canadian~     context.~      Methods: Multicentre RCT in maternity wards of 5 provinces (QC, BC, ON, NS/PE). Parents will~     be randomized to receive the MI intervention (intervention group) or to receive an~     information flyer on vaccines (control group). MI intervention will be delivered by research~     assistant that will have first received a standardized training session on the content and~     techniques of MI. Parents will complete a self-administered questionnaire to measure~     knowledge and vaccination intention as well as VH before and after the intervention.~     Immunization data will be collected through an online questionnaire sent when the child will~     reach 3 months of age.~      Expected benefits: The strategy will be validated across different immunization programs from~     5 Canadian provinces to take account of the differences in logistics and cultural contexts.~     Results from this study will provide to the provincial and national public health authorities~     an effective strategy to tackle VH.~   "
44526|NCT02983994|"~     The aim of the study is to evaluate the errors that may occur during inhalation of two~     devices in patients with asthma, as well as to study whether it relates to the degree of~     control of patient symptoms and the degree of compliance of medication symptoms. Finally, we~     also want to study the degree of patient satisfaction with each of the inhalers studied~   "
44528|NCT02983968|"~     Hepatocellular carcinoma (HCC) has become the second most common cause of cancer death in the~     world, estimated responsible for nearly 745,000 deaths in 2012 (9.1% of all cancer deaths).~     This cancer is closely associated with the presence of chronic liver underlying disease and~     early diagnosis following a systematic surveillance of cirrhotic patients could improve~     disease-free survival in patients declaring HCC. However, the risk-benefit ratio of such~     monitoring is discussed. Nevertheless, it is recommended in patients with liver cirrhosis,~     from which the prevalence is estimated between 0.3% and 0.6% in the French population. This~     debate can lead to a failure to comply with recommendations and promote a large variability~     in the management of the surveillance of HCC in patients with cirrhosis in practice. Data~     acquisition regarding the current situation in France is required.~      The objective of this project is to use this database to document current practices~     concerning monitoring of incidents HCC in cirrhotic patients in France. A retrospective~     cohort study will be conducted on data from SNIIRAM recorded between 2007 and 2015. The~     primary analysis will focus on multivariate modelling of the deviation rate from the~     recommendations (advising the realisation of at least two echodoppler ultrasonographies~     yearly) with a competitive risk model, taking into account gender, social status, Charlson~     index, age at baseline, the alcoholic etiology of cirrhosis, type of facility and the yearly~     number of visits to a hepatologist during follow-up. It is estimated that more than 86,000~     patients with a minimum follow-up of 3 years will be included in the analysis~   "
44529|NCT02983955|"~     The UPnRIDE Powered Wheelchair device is a product which changes people position from sitting~     to standing and standing to sitting. The product provides indoor and outdoor mobility.~      The main purpose of this study is to evaluate the safety of the UPnRIDE powered wheelchair as~     an outdoor and indoor mobility device by individuals with walking impairment.~   "
44530|NCT02983942|"~     Ketogenic diet has shown auxiliary effect on treatment of malignant tumors require high~     glucose consumption. This study is designed to evaluate the safety and efficacy of ketogenic~     diet adjunctive to high dose methotrexate(HD-MTX) chemotherapy for primary central nervous~     system lymphoma (PCNSL).~   "
44531|NCT02983929|"~     The main purpose of this study is to determine the influence of obesity on the short term~     follow-up indicators of a polyvalent geriatric rehabilitation clinic after total knee~     arthroplasty. It is a retrospective, comparative study~      The secondary purposes are to explore the links between length of stay and short-term~     follow-up indicators of a polyvalent geriatric rehabilitation clinic after total knee~     arthroplasty.~   "
44532|NCT02983916|"~     Chronic abdominal and pelvic pain is a common complaint following peritoneal surgery,~     affecting 20-40% of patients. Adhesions account for 60% of chronic postoperative pain cases,~     suggesting that adhesiolysis can play an important role in the management of such pain.~     Despite initial promising results regarding the effect of adhesiolysis on post-operative~     pain, implementation of the procedure has been challenging. The major problems associated~     with adhesiolysis for pain are recurrence of pain, need for invasive diagnosis with high~     rates of 'negative' laparoscopies, and inadvertent bowel injury during surgery. However,~     diagnosis and treatment of adhesions may be improved through the use of novel cine-MRI~     techniques, and with application of anti-adhesion barriers following adhesiolysis.~      In this study the investigators evaluate a new practice-based approach to the problem of~     chronic post-operative pain caused by adhesions. This practice-based approach includes use of~     a novel imaging technique for adhesions (cine-MRI) and shared decision making. Cine-MRI holds~     promise to diagnose and map adhesions. Thus patients with no adhesions, or high risk for~     bowel injury, can be waived from surgical treatment. By using anti-adhesion barriers the~     investigators attempt to prevent adhesion reformation and improve long-term outcomes of~     adhesiolysis.~   "
44533|NCT02983903|"~     Purpose: Patients with peripheral lung nodules require evaluation for lung cancer. Our aim is~     to assess the diagnostic yield of a new technique, transbronchial cryobiopsies, in patients~     at risk for lung cancer. Target population: Patients referred for bronchoscopy and lung~     biopsies as a part of their work up for peripheral lung lesions. Procedures: Patients~     enrolled will have forceps transbronchial biopsies followed by transbronchial cryobiopsies~     for their lung lesion during bronchoscopy.~   "
44534|NCT02983890|"~     This trial is conducted as a cocktail-study namely an open-label, randomized, two-sequence,~     two-period crossover, cocktail study where a combination of cocktail-drugs is used to~     illustrate whether or not, or to what degree dicloxacillin affects the level of activity of~     the 5 most important CYP enzymes and therefore plays a potentially decisive role in serious~     drug-drug interactions.~   "
44535|NCT02983877|"~     This study will test an adherence intervention (iTAB-CV) delivered via interactive text~     messaging which first targets behavioral intent and then adds cues/reminders and~     reinforcement to form the habit of taking antihypertensives in non-adherent individuals with~     BD. Thirty eight individuals with BD and HTN being treated with evidence-based~     antihypertensive agents and mood stabilizing or antipsychotic medications who are~     non-adherent with their HTN medicine will be enrolled.~      This study uses a prospective cohort design with participants serving as their own control.~     Investigators will test the iTAB-CV intervention quantitatively for feasibility and~     acceptability as well as for efficacy in increasing adherence to antihypertensives,~     decreasing systolic blood pressure, and increasing adherence to BD medication.~   "
44536|NCT02983864|"~     The objective of the proposed project is to conduct a randomized controlled trial (RCT)~     comparing sexual assault perpetration and related outcomes (i.e., bystander behavior; rape~     myth acceptance) for men who receive a group alcohol intervention only to men who receive a~     group integrated alcohol and sexual assault intervention.~   "
44537|NCT02983851|"~     VENIM is a multicenter, open-label, parallel-group randomized controlled trial of studying~     the initial ventilation strategy for adult immunocompromised patients with acute respiratory~     failure.~   "
44538|NCT02983838|"~     Target of the research Based on change of Brain-derived neurotrophic factor and other~     pro-inflammatory cytokine along with symptom improvement following treatment, the~     investigators are trying to find the new treatment target molecule. The investigators will~     follow up the subjective and objective cognitive dysfunction with psychiatric symptom~     profiles and compare the neuroimaging related to these change.~   "
45604|NCT02969928|"~     The aim of this study is to assess the clinical outcomes of full-mouth ultrasonic debridement~     combined with clarithromycin or amoxicillin + metronidazole association for the treatment of~     generalized aggressive periodontitis (GAgP).~   "
44540|NCT02983812|"~     In this study, patients will be prospectively enrolled for data collection to design~     prediction models that integrate claims data (inpatient, outpatient, and pharmacy),~     electronic health record data (on clinical, social, and behavioral indicators), and~     patient-generated activity data. Patients will be randomized to use either a smartphone or a~     wearable activity tracking device to capture patient-generated health data.~   "
44541|NCT02983799|"~     This is a non-randomized, open-label study to assess olaparib tablets as a treatment for~     subjects with different homologous recombination deficiency (HRD) tumor status and with~     platinum-sensitive, relapsed, high-grade serous or high-grade endometrioid ovarian cancer.~     Subjects should have received at least 1 prior line of platinum-based chemotherapy.~   "
44542|NCT02983786|"~     The goals of the project are to evaluate a noninvasive monitor of brain metabolism and blood~     flow in critically ill humans. If validated, such a reliable noninvasive brain blood flow and~     metabolism monitor, by allowing physiologic and pharmacologic decisions based on real-time~     brain physiology, potentially will become an important tool for clinicians in their efforts~     to prevent additional brain tissue death in patients admitted with stroke, brain hemorrhage~     and traumatic brain injury.~   "
44543|NCT02983773|"~     This laboratory study will employ a repeated measures experimental design to examine the~     effect of high (7.2% THC) and moderate (3% THC) dose of marijuana, relative to placebo, on~     alcohol craving and on behavioral economic measure of alcohol demand after exposure to~     alcohol cues, and on subsequent drinking in an alcohol choice task in which participants~     choose either to drink or receive monetary reinforcement for drinks not consume. The study~     will recruit 173 non-treatment seeking heavy episodic alcohol drinkers who smoke marijuana at~     least twice weekly.~   "
44544|NCT02983760|"~     Pulmonary embolism (PE) remains a diagnostic challenge. False negative testing exposes~     patient to the risk of potentially fatal recurrence. False positive testing exposes patients~     to potentially fatal unduly side effects of anticoagulants.~      Current diagnostic strategies rely on the sequential use of pretest clinical probability,~     Ddimer test, and chest imaging. Two chest imaging modalities have been validated for PE~     diagnostic exclusion: Computed Tomography Pulmonary Angiography (CTPA) and planar V/Q scan.~     Main limitations of planar V/Q are the high proportion of non-conclusive results, therefore~     requiring additional testing and more complex diagnostic algorithms. Main limitations of CTPA~     are its higher radiation dose and contraindications (renal failure).~      In a randomized trial that compared strategies based on CTPA and on planar V/Q scan, a 30%~     increase in the rate of PE diagnoses was found in the arm using CTPA, raising the hypothesis~     of over-diagnosing and over-treating PE when using CTPA.~      V/Q Single Photon Emission CT (SPECT) is a new method of scintigraphic acquisition that has~     been reported to improve the diagnostic performances of the test, which could reduce the~     number of non-conclusive tests and allow simplified diagnostic algorithms.~      The investigators hypothesize that a strategy based on V/Q SPECT could be an alternative to~     the two usual approaches responding rightly to the two mains issues and combining the~     advantages of CTPA (simplified diagnostic approach) and planar V/Q (no overdiagnosis, lower~     radiation exposure, no contraindication).~      Although a recent survey showed that up to 70% of nuclear medicine centers perform SPECT~     rather than planar imaging for diagnosing PE, a diagnostic management outcome study, in which~     diagnostic decision would be made on the basis of a standardized algorithm based on the V/Q~     SPECT is lacking. Such a study needs to be conducted to ensure that the safety of diagnostic~     exclusion using a V/Q SPECT based strategy is non-inferior to that of previously validated~     strategies, and to verify that the use of V/Q SPECT does not lead to over-diagnosis.~   "
44545|NCT02983747|"~     The purpose of this study is to evaluate the effectiveness of autologous platelet-rich plasma~     (PRP) injection therapy for low back pain patients. Our hypothesis is that PRP will reduce~     the pain feeling and benefit for restore of the intervertebral disk.~   "
44546|NCT02983734|"~     The purpose of this study is to investigate the efficacy of d-cycloserine (DCS) treatment for~     Gulf War Illness (GWI). Gulf War veterans with Gulf War Illness experience numerous chronic~     health symptoms, including cognition and fatigue, which reduces their quality of life. Gulf~     War veterans are in urgent need of novel treatment plans to tackle elusive symptomatology of~     Gulf War Illness. By using the literature of previous studies, the investigators have chosen~     to investigate d-cycloserine as a possible candidate for treating GWI, specifically cognitive~     symptoms. DCS has been shown to reduce neuroinflammation, regulate glutamate levels, and~     improve synaptic functioning in key areas of the brain.~   "
44547|NCT02983721|"~     The purpose of this study was to assess and compare the feasibility, success and safety of~     Transradial approach (TRA) verses Transfemoral approach (TFA) for diagnostic and therapeutic~     coronary angiography and coronary interventions, in terms of procedural time, access time,~     fluoroscopy time, procedural failure, , length of hospital stay in terms of days in hospital,~     Complications in terms of thrombophlebitis, hematoma, ecchymosis, infections thrombosis of~     vessel, MACE, Stroke and others.~   "
44548|NCT02983708|"~     The current study describes a randomized, double-blind, cross-over study of intravenous G-CSF~     followed by infusion with autologous mobilized peripheral blood mononuclear cells (mPBMCs) in~     children with cerebral palsy (CP) to determine the safety and feasibility of the procedure,~     as well as the potential efficacy for improving neurological impairment.~   "
44549|NCT02983695|"~     This is a Phase 1 trial to determine the tolerability and optimal dose of CBD rich cannabis~     extract as an adjunct treatment in children with severe drug resistant epilepsy due to Dravet~     Syndrome. This is an open label intervention. Study duration is 20 weeks to primary analysis~     with continued follow-up until 64 weeks completed.~   "
44550|NCT02983682|"~     This is a study to evaluate the efficacy and safety of lidocaine in the management of chronic~     pain in children. All participants will receive lidocaine infusion and severity of pain and~     degree of chronic-pain related disability will be assessed before and up to 4 weeks after~     infusion. Adverse events will be recorded.~   "
44551|NCT02983669|"~     The aim of this study is to evaluate the effects and safety of a dietary supplement, Zataria~     multiflora Boiss (Shirazi's Thyme) in the treatment of non alcoholic fatty liver disease~     (NAFLD).~   "
44552|NCT02983656|"~     The purpose of this study is to observe the occurrence of adverse events of live attenuated~     varicella vaccine.~   "
44553|NCT02983643|"~     Skeletal Muscle Index (SMI) and Visceral Adipose Ratio (VAR) assess body composition changes~     and disclose malnutrition risk effectively. The aims of the study are to assess prevalence of~     malnutrition in patients planned for SCT, to characterize changes in body composition (SMI,~     total adipose tissue and VAR) that occur in the peri transplantation phase, and to identify~     Waist Circumference (WC) cut off points associated with the metabolic syndrome (MetSyn) in~     patients with B and T cell Lymphoma.~   "
44966|NCT02978261|"~     This phase I, open-label, dose-escalation study was conducted to determine the maximum~     tolerated dose (MTD), recommended phase II dose (RP2D), dose-limiting toxicities (DLTs),~     pharmacokinetics (PK) profile, and preliminary antitumor activity of single and multiple~     doses of PLB1001 in Patients with PTPRZ1-MET fusion gene positive recurrent high-grade~     Gliomas.~   "
44554|NCT02983630|"~     Patients labeled as penicillin allergic, rarely have this confirmed and being labeled as~     penicillin allergic is associated with increased health care costs, adverse effects and~     antibiotic resistance. The investigators will recruit participants from primary care~     practices labeled as penicillin allergic and offer allergy testing. The aim of this study is~     to develop a community, outpatient program for evaluation of penicillin allergy.~   "
44555|NCT02983617|"~     The primary objective of this study is to determine the preliminary efficacy of the~     combination of tirabrutinib (formerly GS-4059) and entospletinib with obinutuzumab in adults~     with relapsed or refractory chronic lymphocytic leukemia (CLL).~      The secondary objective is evaluation of safety and evaluation of additional parameters of~     efficacy. The treatment period is adaptive, with a duration of active treatment up to two~     years and a total follow-up on study of 5 years for time-dependent outcome variables. The~     study has a 6 patient per arm safety run-in to evaluate safety prior to the enrollment of~     subsequent participants.~   "
44556|NCT02983604|"~     The primary objectives of the Phase 1b Dose Escalation part of this study are to characterize~     the safety and tolerability of GS-5829 in combination with exemestane or fulvestrant in women~     with advanced estrogen receptor positive Her2-negative (ER+/HER2-) breast cancer and to~     determine the maximum tolerated dose (MTD) (if not already determined) or the recommended~     dose for the Phase 2 part of this study.~      The primary objectives of the Randomized Phase 2 Dose Expansion portion of this study are to~     evaluate the efficacy of GS-5829 in combination with fulvestrant compared to fulvestrant~     alone in women with advanced ER+/HER2- breast cancer.~   "
44557|NCT02983591|"~     The use of Oxytocin for labor induction may cause receptor exhaustion and thus making its use~     in the third stage of labor ineffective in reducing post partum blood loss as compared to~     other uterotonics.So, we studied the effect of other uterotonic which is misoprostol in~     reducing post partum hemorrhage.~   "
44558|NCT02983578|"~     The goal of this clinical research study is to learn if AZD9150 given in combination with~     MEDI4736 (durvalumab) can help to control advanced pancreatic, lung, or colorectal cancer.~      This is an investigational study. AZD9150 and MEDI4736 are not FDA approved or commercially~     available. They are currently being used for research purposes only. The study doctor can~     explain how the study drugs are designed to work.~      Up to 75 participants will take part in this study. All will be enrolled at MD Anderson.~   "
44559|NCT02983565|"~     Long-term oxygen therapy improves survival in patients with severe hypoxia. However, some~     patients despite this oxygen, experience episodes of low oxygen levels (intermittent hypoxia)~     especially during sleep which may be harmful. In order to overcome this, the investigators~     have designed an auto-titrating oxygen system (called intelligent oxygen therapy) which~     automatically adjusts oxygen flow rates to maintain oxygen levels in patients already on~     oxygen. This study will investigate whether the intelligent oxygen therapy system can prevent~     intermittent hypoxia during sleep in patients already on long-term oxygen.~   "
44560|NCT02983552|"~     The purpose of the study is to compare the efficacy of 1 hour/day of binocular game play 5~     days per week plus spectacle correction with spectacle correction only, for treatment of~     amblyopia in children 4 to <13 years of age.~   "
44561|NCT02983539|"~     The sarcomas represent 1% of all cancers in adults, 8% in adolescents and young people, and~     10% in children. Even though it is a rare cancer, it contributes to a significant loss of~     years of life in comparison with other types of cancer, due the fact that it affects children~     and young people. The diagnosis and treatment are difficult, considering the diversity and~     rarity of this disease. In addition, on average, more than 50% of patients with high-grade~     sarcoma present tumor relapse and distant recurrence is considered the main cause of death.~     The presence of Circulating Tumor Cells (CTCs) in the blood of patients with sarcoma may be~     an early marker of tumor invasion, because it is known that the CTCs circulate in the blood~     for months or years before the development of metastases. The CTCs can be used to monitor the~     response of the tumor to treatment, in order to match time, dose, and type of therapy.~      Objectives: collect blood from patients with different types of sarcoma (leiomyosarcoma,~     synovial sarcoma, pleomorphic sarcoma and liposarcoma) in order to isolate and quantify CTCs.~     The investigators also have an intention to identify genes of resistance to treatment in~     these cells.~   "
44562|NCT02983526|"~     80 patients eligible for a total hip replacement (THR) mainly due to primary osteoarthritis~     were recruited from the waiting list for hip arthroplasty at a university hospital in Sweden.~     The patients were randomized to either CFP or Corail stem, both groups received Delta cup~     from Lima. Randomisation was done using envelopes. Patients could only participate with one~     hip. Patients are evaluated with different questionnaires, radiographs and RSA analysis.~   "
44563|NCT02983513|"~     Preterm infants, during their stay in the Neonatal Intensive Care Unit (NICU), face a period~     of stressful environment, which may negatively impact early brain development and subsequent~     neurobehavioral outcomes. This study aims to assess the effectiveness of training parents in~     reducing stressful experiences early in life and in enhancing brain development and long term~     developmental outcomes.~   "
44564|NCT02983500|"~     Evaluation of patient reported outcomes (PRO) with tumor cachexia in a real life setting.~   "
44565|NCT02983487|"~     Due to waning of infectious as well as vaccine immunity and lack of vaccination boosters, a~     large number of adolescents and adults are no longer immunized against Bordetella pertussis,~     the agent of whooping cough and consequently may contract whooping cough. Furthermore, these~     populations represent a reservoir of the infectious agent from which the dissemination to~     non-immune infants is possible, causing severe illness, or even death, in this age group.~      Few studies have been carried out on whooping cough in developing countries (incidence,~     contaminator's age, etc.) and, specifically, none have assessed the duration of protection~     induced by the whole cell pertussis (wP) vaccine mainly presently used in these countries.~      However, data on the duration of vaccine induced protection are essential to determine i) the~     usefulness of vaccine boosters and ii) the target age group for these boosters.~      The aims of the present study are:~        -  To evaluate the proportion of confirmed pertussis cases in infants presenting whooping~          cough syndrome (WP1a)~        -  To evaluate the proportion of confirmed pertussis cases or healthy carriers among~          contact cases~        -  To determine origin of the infant's contamination (WP1b)~        -  To determine the duration of protection induced by the wP vaccines used in contact cases~          and the child population aged 3 to 15 yo (WP1b and WP2)~        -  To bring new scientific evidences documenting the potential need for initiating boosters~          (WP1b and WP2)~        -  To allow a comparison of the results with those obtained using the same methodology for~          the acellular pertussis vaccine and/or in other contexts. Potential implications for the~          use of pertussis vaccines in low and moderate income countries.~        -  To increase local capabilities by the transfer of materials and expertise that will make~          the diagnosis of pertussis possible in the centres of reference and strengthen a~          pertussis monitoring network in the implicated countries.~        -  To improve children's health through a better match of the vaccination schedule~          according to the reality of the situation.~   "
44566|NCT02983474|"~     The member of National Evidence-based Healthcare Collaborating Agency and the planning~     committee of Korean Association of hepato-biliary pancreatic Surgery established the protocol~     of Korean Surgical Quality Improvement Program (KSQIP) with verifying variables of American~     College of Surgeons - National Surgical Quality Improvement Program (ACS-NSQIP and National~     Clinical Database (NCD) of Japan; demographics, preoperative information, laboratory values,~     operation finding, general occurrences, postoperative occurrences, and follow-up data to~     develop post cholecystectomy complication risk model.~      The 50 surgeons from 20 hospitals have decided to participated in the primary prospective~     study to apply KSQIP to cholecystectomy. The investigators developed web-based database~     system (http://www.ksqip.org/gb) and surgical clinical reviewer of each hospital will fill~     out the case report form. Finally, the investigators will provide a risk-adjusted surgical~     risk calculator and feedback system for reducing complication.~   "
44567|NCT02983461|"~     The investigators goal is to develop medical treatments for stress/mixed urinary~     incontinence. Sildenafil has been shown to improve blood flow as well as muscle mass and~     strength and to decrease muscle fatigue. The investigators believe that it will improve~     muscular atrophy in the pelvic floor, thus improving symptoms of urinary incontinence related~     to pelvic floor dysfunction.~   "
44568|NCT02983448|"~     This is a 2x2 cross over pilot study using low level transcutaneous vagus nerve stimulation~     (LLTS) to reverse diastolic dysfunction in patients with diastolic dysfunction. All patients~     will receive 2 separate, 1-hour sequences, at least 1 day apart, of active and sham LLTS, but~     the sequence will be randomized. Patients will be randomly assigned (1:1) to active/sham or~     sham/active LLTS. LLTS will be performed using a transcutaneous electrical nerve stimulation~     (TENS) device with electrodes attached to the tragus of the ear, which is innervated by~     auricular branch of the vagus nerve. Echocardiography will be performed after 30 minutes of~     LLTS or sham stimulation to assess diastolic function. Five-minute ECGs will be obtained for~     HRV analysis every 15 minutes of stimulation (total of 4 recordings).~   "
44569|NCT02983435|"~     The relevance of this study is to determine the efficacy of two osteopathic techniques -~     Thrust Technique and Muscle Energy Technique (MET) - in improving of neuromuscular component~     of the trunk and clinical symptoms in adult workers with Chronic Low Back Pain (CLBP). Few~     studies have investigated and compared the physiological responses of these techniques~     quantitatively, and no published study has compared their effects in low back pain subjects~     in terms of symptoms, postural balance and muscle activation. The main outcomes will be~     computed by electromyography measurement so that to assess the trunk neuromuscular activation~     pattern as well as by force platform parameters for determining of postural control. Clinical~     symptoms such as pain intensity, perception of disability and fear and avoidance will also be~     computed.~      This is the first study to compare these two osteopathic techniques using the main biological~     outcomes related to trunk neuromuscular function.~   "
44570|NCT02983422|"~     This study evaluates the effects of aminophylline on serum creatinine and urine volume of AKI~     Patient.Half of participants will receive aminophylline and furosemide in combination,while~     the other half will receive only furosemide.~   "
44571|NCT02983409|"~     This is an observational study based on retrospectively collected data of ureter stone~     patients between 2011 and 2014. Aim of study is to determine radiologic findings of~     non-contrast abdominal computerized tomography as predicting clinical outcomes of suspect~     ureter stone patients in emergency department (ED).~   "
44572|NCT02983396|"~     Patient delay in seeking medical attendance for symptoms of acute ST elevation myocardial~     infarction (STEMI) is the major obstacle to reduce the current mortality from acute coronary~     syndromes. The Mini RELF device is a hand held self applicable device intended to detect on~     an individual basis an elevation of the ST segment that is indicative for an acute coronary~     occlusion. The investigators aim to evaluate the accuracy of Mini RELF device when it is~     self-applied on a daily basis by patients with coronary artery disease.~   "
44573|NCT02983383|"~     TAP block is the administration of local anesthetic agents into the anatomic neurofascial~     cavity between the internal oblique and transversus abdominis muscle in the antero-lateral~     region of the abdomen to block the anterior branches of the thoracic intercostal (T7-T12) and~     first lumbar (L1) nerves. TAP block may be a good method for postoperative pain control. We~     aim to show the effect of TAP block administration on analgesic consumption after~     varicocelectomy operations, side effects linked to analgesic use and analgesic quality.~   "
44574|NCT02983370|"~     The objective of this study is to evaluate the usefulness of a cortical visual prosthesis~     based on intracortical microelectrodes to provide a limited but useful sense of vision to~     profoundly blind. This pilot study will provide important information on safety and efficacy~     for the development of an useful cortical visual neuroprosthesis for the blind.~   "
44575|NCT02983357|"~     The purpose of this study is to investigate if the use of autologous bone graft around the~     anchor-peg glenoid prosthesis correlates with (1.) bony apposition on computed tomography~     scans, (2.) decreased radiolucent lines, (3.) a decrease in component loosening, and (4.)~     better functional outcomes. Investigators hypothesize that a glenoid anchor peg component~     fixation utilizing autologous bone graft in Total Shoulder Arthroplasty (TSA) will have a~     lower incidence of glenoid loosening and that the absence of radiolucent lines will correlate~     with excellent shoulder function. Glenoid component loosening remains a major concern~     following total shoulder arthroplasty and is the man reason for failure. Despite positive~     findings in the investigators previous study (same population at a minimum of 2 year post~     operative follow up), it is reasonable that loosening rates could increase with longer~     follow-up. This study will be a minimum of 7 year post operative follow up.~   "
44576|NCT02983344|"~     This study is performed to determine the efficacy of ultrasound-guided fascia iliaca~     compartment block during positioning for spinal anaesthesia in patient undergoing repair of~     proximal femur fracture surgery comparing with intravenous fentanyl.~   "
44577|NCT02983331|"~     In this study, the investigators aimed to overview patients with specific and non-specific~     complications who admitted to intensive care unit following endoscopic retrograde~     cholangiopancreatography and had fatal course in the facility~   "
45836|NCT02966899|"~     The goal of this study is to elucidate the relationship between myocardial right ventricular~     triglyceride content (steatosis) and right ventricular dysfunction in participants with~     pulmonary hypertension, and investigate reversibility of this phenotype with omega-3 fatty~     acid treatment.~   "
44578|NCT02983318|"~     In a number of neuropsychiatric disorders such as depression, both brain inflammation and~     glutamate mediated excitotoxicity (cell death through over-activated stimulation) are~     suspected to play a key role. It is difficult, if not impossible, to determine the potential~     destructiveness of the inflammatory response seen in disease states by studying the brain's~     inflammatory cells (microglia) activity in isolation. The investigators are proposing to~     develop the means to concurrently study inflammatory response (i.e., microglial activity) and~     its potentially devastating consequence (i.e., glutamate excitotoxicity) across the entire~     brain in order to establish the importance of inflammation. In this study the investigators~     propose a phased clinical study whereby the early-phase involves the development of our~     capacity to study inflammation-mediated damage to brain cells, followed by a feasibility~     study in patients with clinical depression that tests whether concurrent inflammation and~     glutamate excess could be measured in key brain regions associated with a depressed mood~     state.~   "
44579|NCT02983305|"~     The goal of this study is to examine the ability of optical head‐mounted display technology~     to enlarge the visual field of patients with severe visual field loss due to retinal~     dystrophy and to improve mobility and patient‐reported outcomes.~   "
44580|NCT02983292|"~     The study is designed as a single center, post-market, non-randomized, open-label,~     observational clinical study with retrospective and prospective enrollment to evaluate the~     2-year post implantation survivorship of the PyroTITAN™ HRA device following the~     implementation of a new proof test to identify and eliminate devices with sub-standard~     mechanical integrity.~   "
44581|NCT02983279|"~     The purpose of this trial is to determine that sort term calorie restriction will affect~     tumor biology in biopsy proven breast, endometrial or prostate cancers, which will positively~     impact biomarkers including miR-21, an onco-miR known to impact cancer outcomes.~   "
44582|NCT02983266|"~     The purpose of this research device study is to learn more about the autonomic nervous~     system. This system uses nerves to send information from the brain to the rest of the body by~     electrical signaling and has two divisions, the sympathetic and the parasympathetic branches.~     It has been thought that electrical stimulation devices could be used to restore balance to~     the nervous system. Because most of the imbalance seems to happen due to too much sympathetic~     activity, the investigator plans to focus on the parasympathetic branch. Specifically, the~     investigator hopes to restore balance by targeting the vagus nerve, which is the main~     communicator of the parasympathetic branch. The study will examine whether the investigator~     can decrease sympathetic activity and chronic inflammation by increasing parasympathetic~     activity. This is a device study that will examine the use of non-invasive vagal nerve~     stimulation to attenuate inflammatory stress and sympathetic hyperactivity in persons with~     Spinal Cord Injury and Non-Disabled Controls.~   "
44583|NCT02983253|"~     Hereditary haemorrhagic telangiectasia (HHT), also known as Rendu-Osler-Weber syndrome, is an~     inherited multisystemic disorder. Literature suggests that HHT is often associated with~     higher frequency of infectious diseases.~      The purpose of this study is to evaluate a variety of immunologic parameters in the blood~     serum of HHT patients in comparison to probands.~   "
44584|NCT02983240|"~     The purpose of this study is to explore a new method to stop preterm uterine contractions~     using an electrical device. The device, an electrical pacemaker for the uterus, has been~     approved by the Food and Drug Administration (FDA) for clinical research in pregnant women.~     The purpose of this study is to evaluate the feasibility and safety of the device. The~     investigators hypothesize that human preterm uterine contractions can be safely and~     objectively inhibited with a weak electrical current provided by an electrical inhibition~     (EI)/uterine pacemaker device, and that this effect relates to the timing and length of EI~     exposure.~   "
44585|NCT02983227|"~     This is a Phase II, multicenter, open-label extension study to evaluate the long-term safety~     and efficacy of GDC-0853 in participants with moderate to severe active RA who have completed~     12 weeks of study treatment in Study GA29350 (NCT02833350). Eligible participants from Study~     GA29350 who elect to participate will receive treatment with GDC-0853 twice daily (BID) in an~     open-label fashion for 52 weeks, followed by a safety follow-up period of 8 weeks.~   "
44586|NCT02983214|"~     Investigation of the clinical efficacy and safety of dual antiplatelet therapy with~     clopidogrel and cilostazol versus clopidogrel alone in preventing ischemic vascular events in~     patients with type 2 diabetes and symptomatic peripheral arterial disease.~   "
44587|NCT02983201|"~     The objective of this trial is to further confirm and assess the efficacy of filiform needle~     therapy on the common orthopedic pain syndromes and investigate whether or not thumbtack~     needle therapy could further enhance the clinical efficacy and pain healing effect of the~     filiform needle therapy.~   "
44588|NCT02983188|"~     One double-blind, randomized, placebo-controlled trial is designed to examine whether~     berberine added to current antipsychotic drugs could produce significantly greater efficacy~     in reducing atypical antipsychotic-induced metabolic syndrome. To achieve this objective, 120~     patients with schizophrenia spectrum disorders (SSD) who have developed metabolic syndrome~     will be recruited and randomly assigned to receive additional treatment with placebo (n = 60)~     or berberine (n = 60, 1.2 g/day, 0.4 g, t.i.d.) for 12 weeks. The primary outcome is weight~     gain; other outcomes include body mass index (BMI), waist circumference, blood pressure,~     triglycerides (TG), total cholesterol, high-density lipoprotein (HDL), and low-density~     lipoprotein (LDL), fasting glucose, insulin, and insulin resistant index.~   "
44597|NCT02983071|"~     This is a study to investigate the potential clinical benefit of G1T38 as an oral therapy in~     combination with fulvestrant in patients with hormone receptor-positive, HER2-negative~     metastatic breast cancer.~      The study is an open-label design, consists of 2 parts: dose-finding portion (Part 1), and~     expansion portion (Part 2). Both parts include 3 study phases: Screening Phase, Treatment~     Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with~     study treatment and completes at the Post-Treatment Visit. Approximately, 102 patients will~     be enrolled in the study.~   "
44598|NCT02983058|"~     The primary goal of the present study is to evaluate the utility of mGluR5 binding as~     measured by PET as biomarker of the CNTNAP2 mutation and related mTOR kinase pathway~     dysregulation.~   "
45879|NCT02966340|"~     Double-blind, placebo-controlled, cross-over design study examining the effects of a~     norepinephrine alpha1 receptor antagonist (prazosin) on stress reactivity in a laboratory~     stressor task.~   "
44589|NCT02983175|"~     Performing anesthetic induction for appendicectomy has two main risks : first aspiraion of~     gastric content causing pneumonia. Otherwise, anaphylactic risk to drugs used during~     anesthetic induction. Indeed, the guidelines recommend an anesthetic induction protocol~     qualified full stomach whatever the patient and the preoperative fasting period are. This~     protocol provides the use of fast-acting neuromuscular blocking agents (succinylcholine or~     rocuronium). However, these neuromuscular blocking agents are ten times more at allergic risk~     than others. Ultrasound assessment of gastric content before rapid sequence induction of~     anesthesia is a reproducible, non-invasive, inexpensive and quickly achievable bedside~     technique. Furthermore, the correlations between gastric volume and risk of a full stomach~     and also between the cross-section antral area (CSA) and the risk of a full stomach have been~     validated on several patient cohorts. We formulate the hypothesis that the achievement of a~     gastric ultrasound before anesthetic induction for appendectomy could allow to identify full~     stomach patients who actually justify rapid sequence induction of anesthesia with exposure~     to fast-acting neuromuscular blocking agents that implies.~      Primary endpoint is to determine te percentage of patients who have a gastric content before~     appendectomy. Secondary endpoint is to determine the incidenc of aspiration pneumonia and~     anaphylactic shock. Another secondary endpoint is to determine the percentage of patient with~     gastric content with the antral grading system (Perlas method) and to evaluate the~     concordance between this methode and the cross-section antral area.~   "
44590|NCT02983162|"~     Rationale: Retrospectively reviewing the participants of the GODDAF database, revealed a~     significant association between the weighted genetic risk score and Dupuytren disease~     recurrence. However, a significant dose-response relation was not found. This might be caused~     by underestimating the recurrence rate, due to the retrospective nature of determining~     recurrence. Therefore, we want to do a follow-up measurement of the GODDAF participants, to~     see whether they suffered from recurrent disease.~      Objective: We aim to determine whether the wGRS is associated with recurrent DD.~      Study design: An observational study, in which the participants of the GODDAF study are~     followed up.~      Study population: Patients affected by Dupuytren disease, aged 18-96 years, who were~     previously included in another study on the genetic basis of Dupuytren disease.~      Intervention (if applicable): NA Main study parameters/endpoints: The main study parameter is~     the presence of recurrent Dupuytren disease.~   "
44591|NCT02983149|"~     Patients undergoing thoracic surgery require selective ventilation of one lung, which allows~     surgery to proceed on the operative lung that is deflated, and no longer moving. One-lung~     ventilation (OLV) may be achieved by the use of a double lumen endotracheal tube (DLT) or the~     placement of a bronchial blocker (BB) via a single lumen endotracheal tube, both of which are~     in routine clinical use at University Health Network.~      Recently, the Endobronchial Blocker (EZ blocker) has been marketed, with a forked tip design~     and two balloons, one of which is designed to fall into each of the right and left sides, it~     may require less repositioning. Initial clinical experience with the EZ Blocker suggests that~     it may be less likely than other blockers to become malpositioned during surgery.~      This study will compare the EZ blocker to the Fuji blocker, the most frequently used blocker~     at this institution, and to double-lumen tubes, the most commonly used devices to provide~     lung isolation, with respect to intra-operative malpositioning and the speed of lung~     separation and efficacy of lung collapse during thoracic surgery.~      Patients will be randomly assigned, to one of the three study groups: EZ Blocker, Fuji, or~     left-sided DLT, immediately prior to induction of anesthesia.~      The primary end points of time to lung isolation and number of required repositioning~     maneuvers.~   "
44592|NCT02983136|"~     The aim of this integrated Knowledge Translation (iKT) study is to develop and test a~     multifaceted implementation intervention for feasibility, acceptability and effectiveness.~     The intervention will be tailored to fit the context of the operating room (OR), to promote~     OR team members' use of aseptic techniques during the care of frail persons undergoing acute~     fracture surgery of the hip.~      Through the use of an iKT approach, the investigators hypothesise that building on leadership~     support, partnership between researchers, managers/clinical leaders and healthcare~     professionals, a solid foundation for the sustained implementation of patient safety~     innovations can be created.~   "
44593|NCT02983123|"~     This study evaluates if the 1-hour rule-in/rule-out algorithm for a high-sensitivity cardiac~     troponin T (hs-cTnT) is safe and effective in patients with a lower pretest probability of an~     acute myocardial infarction (MI). During this study troponins will be collected at 0-, 1- and~     4/6-hours, where absolute changes in the values will decide whether the patient need~     hospitalization or not. Can the time interval to the second troponin test be reduced by using~     an 1-hour high-sensitivity assay?~   "
44594|NCT02983110|"~     The purpose of this research study is to better understand how sex hormone therapy that is~     used to treat women for menopausal symptoms, men with low testosterone, or as hormone therapy~     for transgender women, affects a class of medications called NRTIs (nucleoside reverse~     transcriptase inhibitors) used to treat and prevent HIV infection. The two most commonly used~     NRTIs are tenofovir and emtricitabine, which are the components of the drug Truvada and also~     included in the combination products Atripla, Complera, and Stribild. The medication's~     ability to work effectively may be altered when someone is also taking sex hormone therapy.~      In order to determine this effect, samples will be collected from some parts of the body~     where HIV makes copies. These samples will be measured for the levels of HIV medication, HIV~     virus and sex hormones that are present. The samples that will be looked at in this study~     include blood, cells from the vagina, semen, and tissue biopsies from the female genital~     tract and rectum.~   "
44595|NCT02983097|"~     The goal of this study is to evaluate efficacy and safety of the combination of lenalidomide,~     an immunomodulatory drug (IMiD) with a standard immunochemotherapy treatment, called R-DHAP.~     R-DHAP consists of a monoclonal antibody called Rituximab and chemotherapy consisting of~     Dexamethasone, high dose Cytarabine, often called Ara-C, and platinum based chemotherapy,~     either cisplatinum, or, if treatment with cisplatinum is contraindicated, carboplatinum.~   "
44596|NCT02983084|"~     The purpose of this randomized clinical trial (RCT) is to compare traditional CuNiTi~     archwires and a recently marketed multiforce version of the same material for the initial~     alignment and leveling of dental arches, as well as the expression of EARR in adult~     orthodontic patients.~   "
45920|NCT02965794|"~     EVALUATE THE CARE PROCESS AND THE QUALITY OF CARE FOR ADULT CANCER PATIENTS WHO ARE ADMITTED~     FOR COLORECTAL SURGERY~   "
44599|NCT02983045|"~     This study is to determine first, the recommended Phase 2 dose (RP2D) of NKTR-214 when~     administered in combination with nivolumab, and then, the clinical benefit, safety, and~     tolerability of combining NKTR-214 with nivolumab at the RP2D in select patients with~     Melanoma, Renal Cell Carcinoma, Non-Small Cell Lung Cancer, Urothelial Carcinoma, or Triple~     Negative Breast Cancer. The study will also determine the RP2D of NKTR-214 in combination~     with nivolumab and ipilimumab, and then the clinical benefit, safety, and tolerability of~     this triplet combination in select patients with RCC or NSCLC.Both All three drugs target the~     immune system and may act synergistically to promote anti-cancer effects.~   "
44600|NCT02983032|"~     Background: between 50-74% of dementia carers report some sleep disturbance. However,~     relatively few studies have looked at psychological treatment for insomnia in this group.~     Dementia carers may be particularly at risk for suffering negative consequences from the~     impact of sleep loss on top of the stress of their carer role. Researchers have found that~     Brief Behavioural Treatment for Insomnia (BBTI) can be effective for improving symptoms of~     insomnia in older adults. BBTI focusses on sleep-related behaviour such as napping and when a~     person gets up and goes to bed.~      Aims: this study aims to explore whether delivering group-based, Brief Behavioural Treatment~     for Insomnia (BBTI) to family carers of people with dementia is feasible, given that, to~     date, this has not yet been explored.~      Who is eligible?: carers with insomnia who care for a family member with dementia and live~     with them at home are eligible for inclusion in this study.~      What is involved for participants?: taking part will involve an initial telephone discussion~     with a researcher to check suitability. Participants will then meet the researcher for~     assessment. Assessment includes a sleep interview and completing some questionnaires.~     Participants will then be required to attend 3 group sessions of BBTI across the space of 4~     weeks. After attending the BBTI group, participants will be asked to fill in some of the same~     questionnaires that they filled in during assessment and again 4 weeks later. Participants~     will also be invited to take part in a focus group to give feedback about the treatment and~     their overall experience of being in the study.~   "
44601|NCT02983019|"~     This study evaluates the statistics of influenza and acute respiratory viral infections~     (ARVI) management in outpatient sites in Russia, Armenia, Moldova and Georgia (epidemiology:~     disease severity and bacterial exacerbations; patients demography; treatment duration and~     timelines; safety; quality of treatment) in routine clinical practice with focus on drug~     therapy and usage of interferons' inducers.~   "
44602|NCT02983006|"~     The purpose of this study is to evaluate the safety profile, tolerability, and~     immunoregulatory (pharmacodynamic; PD) activity of DS-8273a administered in combination with~     nivolumab (anti-PD-1 antibody) to subjects with unresectable Stage III or Stage IV melanoma.~   "
44603|NCT02982993|"~     This study provides Hepatitis C virus screening to the members of the World Trade Center~     Health Program followed at the Icahn School of Medicine at Mount Sinai born during 1945-1965,~     and linkage to care for those found infected. The study will also determine if exposure to~     human remains, blood and/or bodily fluids during the World Trade Center Health Program~     activities are associated with Hepatitis C virus infection. These findings would be relevant~     to the larger United States population, especially to persons born during 1945-1965 who are~     at high risk of Hepatitis C virus infection.~   "
44604|NCT02982980|"~     The presence of pain, reduced range of motion and decrease of muscle strength of the upper~     limb in the early postoperative period are some of the major deficiencies of the breast~     cancer patients.~      The objectives of this study were to evaluate muscle strength, range of motion (ROM), pain,~     perimetry of the upper limbs and applied questionnaires of the upper lim function and quality~     of life, in patients after surgical treatment of breast cancer in different postoperative~     periods and different groups following rehabilitation: traditional postoperatively exercise~     to perform at home versus traditional exercises associated with weekly physiotherapy sessions~     to strength training for shoulder movements.~   "
44605|NCT02982967|"~     The purpose of present study was to investigate the effect of 10 weeks of recreational~     physical activity program on the irisin levels, progenitor endothelial cells and~     cardiometabolic profile in healthy children. Also, we investigated the correlation between~     this markers with anthropometric data, body composition, cardiac autonomic balance and~     physical fitness parameters. We evaluated eighty children aged 6 to 14 participated in the~     recreational physical activity program by 10 weeks (Duration: 60 minutes; Intensity: 65%-85%~     heart rate reserve; Frequency: 4 sessions/week). All parameters were evaluated before and~     after this approach.~   "
44606|NCT02982954|"~     To investigate the safety of Nivolumab in combination with Ipilimumab in subjects with~     previously untreated advanced or metastatic Renal Cell Cancer.~   "
44607|NCT02982941|"~     This study is a Phase 1, open-label, dose escalation and cohort expansion trial designed to~     characterize the safety, tolerability, PK, PD, immunogenicity and preliminary antitumor~     activity of enoblituzumab administered IV on a weekly schedule for up to 96 doses~     (approximately 2 years) in children and young adults with B7-H3-expressing relapsed or~     refractory malignant solid tumors.~   "
44608|NCT02982928|"~     The current study is designed to measure and evaluate the pharmacokinetic profiling of~     acetaminophen in the young obese patient population.~   "
44609|NCT02982915|"~     This is a phase I/II, randomized, blinded and placebo-controlled study to test the safety and~     efficacy of LMCSs for improving vaccine immune response.~   "
44610|NCT02982902|"~     The purpose of this study is to determine if a specific type of cell-based immunotherapy,~     using T-cells from a donor that are specific against cytomegalovirus (CMV) is feasible to~     treat infections by CMV.~      Adoptive T-cell therapy is an investigational (experimental) therapy that works by using the~     blood of a donor and selecting the T-cells that can respond against a specific infectious~     entity. These selected T-cells are then infused to the patient, to try to give the immune~     system the ability to fight the infection. Adoptive T-cell therapy is experimental because it~     is not approved by the Food and Drug Administration (FDA).~   "
44611|NCT02982889|"~     This study is designed to assess and characterize the safety and tolerability profile of~     LIQ865A and LIQ865B formulations compared to diluent or aqueous bupivacaine hydrochloride~     when infiltrated into a defined area of the medial calf, and to characterize bupivacaine~     plasma pharmacokinetic (PK) and pharmacodynamic (PD) profiles after a single dose of LIQ865A~     or LIQ865B, and to determine the individual plasma concentration/time curves and mean PK~     parameters of each product.~   "
44612|NCT02982876|"~     Airway stents are used as standard of care to identify which patients with excessive dynamic~     airway collapse will benefit from a definitive surgical treatment. However, the specific way~     in which these stents are effective has not been tested. The purpose of this research study~     is to determine the effectiveness of airway stents when used in the airways of patients with~     severe symptomatic excessive dynamic airway collapse compared to patients with severe~     symptomatic excessive dynamic airway collapse that do not receive airway stent.~   "
44613|NCT02982863|"~     1. To understand the treatment patterns of OACs and baseline patient characteristics of~          Japanese Non-Valvular Atrial Fibrillation (NVAF) patients~        2. To determine whether warfarin and dabigatran new user group can be balanced using~          propensity score matching using pre-specified baseline covariates.~        3. As an exploratory analysis, to assess mean duration of on-therapy follow-up time in~          database~   "
44614|NCT02982850|"~     The prevalence of AF, which is tachyarrhythmia, is approximately 2% of the entire population~     and 5% of the population at the age of 60 or older. AF is the cause of approximately 20% of~     all events of ischemic stroke, and patients with AF are known to be at 6 to 10% risk of~     ischemic stroke per year. Patients with valvular AF are known to have a higher incidence of~     stroke than patients with nonvalvular AF. However, the relevant data are insufficient as~     large randomized studies comparing NOAC treatment with warfarin, a conventional treatment,~     did not include many patients with moderate and severe valvular AF.~      Ischemic stroke is divided into symptomatic stroke with brain lesions on brain magnetic~     resonance imaging (MRI) and silent cerebral infarct with lesions on brain MRI but without~     stroke symptoms. According to a brain MRI follow-up study, the incidence of silent cerebral~     infarct was 17.7% (254 subjects) over a period of 5 years, with 11.4% of 254 subjects~     reporting to have experienced symptoms. This means that the incidence of silent cerebral~     infarct is approximately 9 times that of symptomatic stroke. In addition, patients with a~     history of silent cerebral infarct are known to be approximately twice more likely to~     experience stroke in the future than those without a history of silent. Brain microbleed is~     easily detected by brain MRI and is a well-known independent predictor of intraparenchymal~     hemorrhage and silent cerebral infarct. The prevention of stroke by the study drug can be~     indirectly assessed based on the incidence of silent cerebral infarct and brain microbleed on~     brain MRI. Investigators tried to compare effect of dabigatran with conventional treatment in~     terms of prevention of stroke by comparing incidences of silent cerebral infarct and brain~     microbleed and symptomatic stroke using brain MRI.~   "
44615|NCT02982837|"~     To assess whether PEG-INF (Peglyated - interferon) Add-on therapy in patients of CHB who have~     achieved a maintained viral suppression (HBV DNA PCR( polymerase chain reaction) <200 for~     last 3-6 month) with NA's can result in increased rate of HBV infection eradication (HbsAg is~     undetectable by serological blood testing with or without seroconversion to HBs antibody).~   "
44616|NCT02982824|"~     Effect of oral magnesium sulfate (Mg) supplementation will be studied. Children with drug~     resistant idiopathic epilepsy following up in Pediatric Neurology Clinic, Ain Shams~     University, will be randomized to either Mg add-on treatment group or anti-epileptic drugs~     AEDs alone. Serum magnesium, seizure control and Intelligent quotation (IQ) will be done at~     base line and after 6 months of treatment.~   "
44617|NCT02982811|"~     The purpose of this study is to determine whether additional therapy with i-ACT system is~     effective in the training of functional skills in persons with central neurological diseases~     (e.g. multiple sclerosis, stroke, spinal cord injury, etc.).~   "
44618|NCT02982798|"~     A randomized, open-label, single dose, crossover study to compare the pharmacokinetic~     characteristics of the co-administration of metformin SR and rosuvastatin and JLP-1310 in~     healthy male volunteers~   "
44619|NCT02982785|"~     The aim is to assess if physiotherapists attending inpatients at elective orthopaedic wards~     can predict the future course (post hospitalisation) of recovery of patients undergoing KA.~     The prediction is made at hospital discharge using a 1-10 numerical rating scale (1=poor~     prognosis; 10=best prognosis).~      To identify candidate prognostic factors, the therapist are asked to qualify their prognosis~     narratively, by listing at least 3-5 factors that they consider important for their projected~     prognosis score. There will be no maximum number of factors the physiotherapist can list.~   "
44620|NCT02982772|"~     The overall objective of the transdisciplinary team of Human Immunology Virus (HIV) and~     Tobacco funded researchers is to test if tailoring nicotine replacement doses to temper these~     excessive levels will enhance the efficacy of the intervention. To test researchers proposed~     model 600 people living with HIV (PLWH) ready to quit smokers will be enrolled in a~     double-blind randomized clinical trial intent-to-treat design, comparing a standard~     well-validated brief smoking intervention, that following national guidelines + nicotine~     replacement therapy (NRT), versus the tailored one (brief smoking intervention + personalized~     doses of nicotine replacement therapy). The primary outcome for this study will be rates of~     smoking cessation, point prevalence abstinence (prior 7 and prior 30 days), and verified~     continuous abstinence 3-, 6-, and 12-months post scheduled quit day.~   "
44621|NCT02982759|"~     Obesity among Hispanic children in the Lower Yakima Valley of Washington State is alarmingly~     high. This study proposes to implement a comprehensive, multi-level intervention among~     children, families, the schools, and the community to combat this problem. The two year~     intervention will be measured by examining changes in children's body mass index.~   "
44622|NCT02982746|"~     At all of the follow-ups, including the worst period (between four and ten weeks), the~     intervention group reported higher scores than the control group, suggesting in this RCT that~     adopting the person-centred-care concept was a promising way to improve function and~     wellbeing in patients with HNC.~   "
44623|NCT02982733|"~     In 2008 Goker et al, introduced Ankaferd Blood Stopper (ABS) as a new hemostatic drug.~     Recently, ABS has been shown to produce local hemostasis by implementing topically after~     major arterial vessel injury. Reducing the compression time during patent hemostasis by~     facilitating hemostasis may decrease RAO. To test this hypothesis the investigators planned a~     three arm randomized study to evaluate the safety and efficacy of Ankaferd blood stopper in~     adjunct to short-time compression, compared to either short-time compression with~     conventional sterile gauzes or with a TR band after transradial diagnostic procedures.~   "
44627|NCT02982681|"~     Background: Platelet-rich fibrin (PRF) and bioactive glass putty has been shown to be~     effective in promoting reduction in probing depth, gain in clinical attachment, and defect~     fill in intrabony periodontal defects. The individual role played by bioactive glass putty in~     combination with PRF is yet to be elucidated.~      AIM: To compare the clinical effectiveness of the combination of Plaltelet Rich Fibrin and~     Bioactive Glass Putty and Bioactive glass putty regenerative techniques for intrabony defects~     in humans.~      Material and methods: Ten pairs of intrabony defects were surgically treated with PRF and~     Bioactive glass putty (Test group) on one side or bioactive glass putty (Control group) on~     other side. The primary outcomes of the study included changes in probing depth, attachment~     level and bone fill of Osseous defect. The clinical parameters were recorded at baseline, 3,~     6, and 9 months. Radiographic assessment was done using standardized intra oral periapical~     radiographs. Comparisions were made within each group between baseline, 3 months, 6 months~     and 9 months using the ANOVA test followed by Bonferroni test.~   "
44628|NCT02982668|"~     The purpose of this academic lead study is to explore the ideal nutritional support strategy~     for patient with acute severe stroke.~   "
44629|NCT02982655|"~     The purpose of this academic lead study is to explore ideal blood pressure targets and~     optimum individualized anti-hypertension strategies in acute severe stroke.~   "
44630|NCT02982642|"~     This study is a 52-weeks, multicenter, randomized, double-blind, placebo controlled, parallel~     trial which will be carried out in 15 centers around China. The study population includes~     amnestic mild cognitive impairment patients (planned a total of 240) aged 55-85 in both~     gender. Participants will be randomly allocated to 1612 capsules (1.14g per time, 3 times per~     day) or placebo for a 52-weeks double-blind treatment period. The primary outcome measure is~     change from baseline in the Alzheimer's Disease Assessment Scale- Cognition Subscale~     (ADAS-cog) and rate of conversion to dementia. The secondary outcomes are changes from~     baseline in the Mini-Mental State Examination (MMSE), Delayed Story Recall test (DSR),~     Alzheimer's Disease Cooperative Study/Activities of Daily Living scale adapted for MCI~     patients (ADCS/MCI/ADL24). Safety is being assessed by observing side effects and adverse~     reaction during the entire treatment period. Statistical analysis will be conducted according~     to per-protocol population and intend-to-treat population and the safety will be analyzed in~     safety set.~   "
44631|NCT02982629|"~     1. To design and develop a prospective, randomized pilot study utilizing information from~          electronic medical records to address follow-up adherence and reduce the gap between~          recommended and actual follow-up adherence in patients with glaucoma.~        2. To evaluate the impact of a telephone-based intervention on follow-up adherence in~          patients with glaucoma using a randomly assigned comparison with usual care.~   "
44632|NCT02982616|"~     The purpose of this study is to test whether intragastrically infused fatty acid will~     interact with positive emotion induction and if this effect is mediated by gut hormones.~   "
44633|NCT02982603|"~     This study is a 52-weeks, multicenter, randomized, double-blind, double- placebo, parallel~     controlled phase VI trial being carried out in 20 centers around China. The study population~     includes amnestic mild cognitive impairment patients (planned a total of 360) aged 55-85 in~     both gender. Participants will be randomly allocated to Qinggongshoutao bolus (7g per time,2~     times per day) and placebo identified to Ginkgo biloba (Ginaton), Ginkgo biloba (Ginaton)~     (80mg per time, 2 times per day) and placebo identified to Qinggongshoutao bolus, or placebo~     identified to Qinggongshoutao bolus and placebo identified to Ginkgo biloba (Ginaton) for a~     52-weeks double-blind treatment period. The primary outcome measure is change from baseline~     in the Alzheimer's Disease Assessment Scale- Cognition Subscale (ADAS-cog) and rate of~     conversion to dementia. The secondary outcomes are changes from baseline in the Mini-Mental~     State Examination(MMSE), Delayed Story Recall(DSR), Alzheimer's Disease Cooperative~     Study/Activities of Daily Living scale adapted for MCI patients (ADCS/MCI/ADL24). Safety is~     being assessed by observing side effects and adverse reaction during the entire treatment~     period. Statistical analysis will be conducted according to per-protocol population and~     intend-to-treat population and the safety will be analyzed in safety set.~   "
44634|NCT02982590|"~     The purpose of this study is to compare the novel oral anticoagulant apixaban with the~     standard therapy of warfarin on the size reduction or resolution of left ventricular thrombus~     over 6 months.~   "
44635|NCT02982577|"~     The purpose of this study is to evaluate the effectiveness of a spray the basis of~     pilocarpine on salivary flow of patients with xerostomia, by radiation therapy, and primary~     Sjögren's Syndrome treated at the Clinics Hospital of Faculty of Medicine of Ribeirão Preto~     (HCFMRP-USP), and its impact on quality of life.~   "
44636|NCT02982564|"~     The purpose of this study is to evaluate the effect of two exercise programs: 1) one program~     will be at low intensity; 2) the other program will be at moderate intensity. One hundred~     forty two women who are breast cancer survivors will be recruited. Participants will be~     educated on a home exercise program to be performed at either low or moderate intensity,~     according to group assignment. Evaluations to participants will consist of function and~     quality of life.~   "
44637|NCT02982551|"~     This study evaluates the effects of changing insulin levels on brain activity. Participants~     will complete functional magnetic resonance imaging (fMRI) scans during fasting conditions,~     then during an insulin infusion.~   "
44638|NCT02982538|"~     This randomized study examines how prolonged exposure (PE) therapy, an evidence-based~     treatment for posttraumatic stress disorder (PTSD), can be successfully disseminated and~     implemented in the Army. The study compares two PE training models: Standard PE training,~     comprised of a 4-day workshop only, and Extended PE training, comprised of a 4-day workshop~     plus expert case consultation. In addition, patients with posttraumatic stress symptoms~     receiving psychotherapy from participating providers will be invited to participate. After~     completing PE training, use of PE components with patients reporting PTS symptoms and~     clinical outcomes of these participating patients will be monitored for up to 18 months.~   "
44707|NCT02981628|"~     This phase II trial studies how well inotuzumab ozogamicin works in treating younger patients~     with CD22 positive B acute lymphoblastic leukemia that has come back or does not respond to~     treatment. Immunotoxins, such as inotuzumab ozogamicin, are antibodies linked to a toxic~     substance and may help find cancer cells that express CD22 and kill them without harming~     normal cells.~   "
44639|NCT02982525|"~     A significant proportion of the United Kingdom population have inadequate levels of vitamin D~     in their blood. Vitamin D is a fat-soluble vitamin that is essential for the growth and~     maintenance of healthy bones through increasing dietary calcium absorption within the body. A~     low vitamin D status has also been associated with other diseases such as osteoporosis,~     cancer (especially colorectal cancer), cardiovascular disease and type 1 diabetes. Our skin~     is able to synthesise vitamin D upon exposure to sunlight in summer. If exposure to sunlight~     is limited, then a dietary supply of vitamin D becomes essential.~      However, very few foods contain vitamin D. Among the best dietary sources of vitamin D are~     oily fish (including salmon, mackerel, herring and trout) and fish oils. Recently, the~     investigators found that certain shellfish, especially mussels, contain significant amounts~     of a metabolite of vitamin D, 25(OH)D3. Consumption of this metabolite, as a supplement, has~     already been shown to improve vitamin D status in humans. Whether consumption of mussels~     improves vitamin D status is unknown.~      In this study the investigators will be looking at whether consumption of 1, 2 or 3 portions~     of mussels per week for 12 weeks increases vitamin D status in healthy people.~   "
44640|NCT02982512|"~     The implantation of a deep brain stimulator (DBS) is an established option to improve the~     symptoms of Parkinson's disease (PD) in patients that do not respond adequately to medical~     therapy. Most centers perform this surgery using a technique that involves microelectrode~     recording (MER) of neuronal activity for localization of the target nucleus, microstimulation~     of identified targets, and neurological intraoperative testing in a cooperative patient.~      Dexmedetomidine, a α2-adrenergic receptors agonist, is a potent anxiolytic that acts at~     subcortical areas of the brain without involving GABA receptors. It provides excellent~     sedation without respiratory depression; also, it has an analgesic component and a~     predictable hemodynamic response. Low maintenance doses do not appear to interfere with MER.~     The possible effect of dexmedetomidine in the PD symptoms is still unclear.~   "
44641|NCT02982499|"~     The participant is being asked to be a subject in this research study because the participant~     may have a disorder that can cause optic nerve damage and impairment of his/her visual~     function which is called optic neuropathies (ON). Optic neuropathy refers to damage to the~     optic nerve (a cable connecting the eyes and the brain to transmit the visual signals) due~     to any cause.In this study, the investigator is using magnetic resonance imaging (MRI) and~     ophthalmic measures such as optic coherent tomography(OCT), which are non-invasive imaging~     tests to measure the changes in eye globe shape ,the flow of blood and brain fluid. It is~     hoped that this study will provide new knowledge that may allow the investigator to better~     understand the cause of symptoms associated with optic neuropathy and ways to better monitor~     what is happening.~   "
44642|NCT02982486|"~     The purpose of this study is to determine whether nivolumab plus ipilimumab are effective and~     safe in the treatment of sarcoma and endometrial carcinoma patients with somatic deficient~     MMR as a selection tool.~   "
44643|NCT02982473|"~     The Registry of Malignant Arrhythmias and Sudden Cardiac Death - Influence of Diagnostics~     and Interventions (RACE-IT) represents a mono-centric registry of patients being~     hospitalized suffering from malignant arrythmias (ventricular tachycardia or fibrillation)~     and sudden cardiac death (SCD).~      Detailed findings of patients' clinical outcome regarding mortality and co-morbidities~     related to the presence of invasive diagnostics or therapies including coronary angiography,~     percutaneous coronary intervention (PCI), electrophysiological testing (EP), catheter~     ablation and implanted cardiac devices (e.g. implantable cardioverter-defibrillators) will be~     documented. Patients will be included when being hospitalized from the year 2004 until today.~   "
44644|NCT02982460|"~     Rotator cuff tendinopathy (RCT) is regarded as a common and burdensome source of shoulder~     pain with prevalence estimated to be as high as 14% in general working-age population. RCT is~     a broad entity, including a vast variety of diagnosis such as shoulder impingement syndrome,~     RC tendinitis/tendinosis, as well as subacromial bursitis. The course of RCT is characterised~     by persistent pain and/or disability and/or recurrent episodes. It often leads to decrease~     function, lower health-related quality of life, poor sleep quality, work absenteeism, as well~     as patient's suffering. Previous studies support exercise as an adequate treatment in RCT.~     Nevertheless, our knowledge, there is no studies evaluating the effects of isoinertial~     training in RCT. Therefore, the aim of this study will be to pilot the methods proposed to~     conduct a substantive study to evaluate the efficacy of isoinertial training plus eccentric~     training versus eccentric training alone on improving pain and function in RCT. The~     objectives were to evaluate: (i) The process of recruitment and retention rates; (ii)~     Willingness of participants to be randomised; (iii) The extent of contamination between~     groups; (iv) Participant adherence with treatment. The secondary aim will be to analyse the~     effects of isoinertial training plus eccentric training versus eccentric training alone on~     rotator cuff strength, scapular muscle activity, and scapular muscle endurance in people with~     RCT.~   "
44645|NCT02982447|"~     It is a randomized controlled trial with tandem colonoscopy.Participants were randomized for~     use of either blue laser imaging or conventional White Light Colonoscopy on withdrawal~     method.comparison of detection and miss rates of BLI group Versus conventional White Light~     Colonoscopy.~   "
44646|NCT02982434|"~     The aim of this prospective randomized double-blind study was to compare the efficacy of new~     pharmaceutical composition containing botulinum toxin injection in epicardial fat pads for~     preventing recurrences of atrial tachyarrhythmia in patients with paroxysmal atrial~     fibrillation undergoing coronary artery bypass grafting.~   "
44647|NCT02982421|"~     Art Therapy is a health profession in which art making is utilized as a means of expression~     and communication within a therapeutic and supportive relationship [1]. Art therapy has been~     shown to reduce psychological (anxiety, negative mood) and physical (pain, fatigue) symptoms~     which accompany many breast cancer patients and survivors [2-7]. Qualitative studies provide~     an initial understanding of the mechanisms through which art therapy facilitates symptom~     reduction [8]. Breast cancer patients have reported that art therapy provided them with~     access to emotional material otherwise inaccessible [9]. The goal of this study is to examine~     the effect of art making within a therapeutic framework on emotional awareness and~     acceptance.~   "
45937|NCT02965573|"~     This is a randomized, double-blind, placebo-controlled, multicenter Phase II study to~     evaluate the safety, efficacy, and pharmacokinetics of ARGX-113 for the treatment of~     autoimmune Myasthenia Gravis (MG) with generalized muscle weakness.~   "
44648|NCT02982408|"~     Low birth weight (LBW), a marker of impaired fetal growth is an independent and strong risk~     factor for type 2 diabetes (T2D). A western lifestyle characterized by a surplus of calories,~     and/or a low physical activity level, associated with increased fat storage and altered lipid~     metabolism plays a central role in the pathogenesis of insulin resistance and T2D. Using~     state-of-the-art large-scale integrative physiology studies combined with basic studies of~     adipose and muscle tissue stem cell functions, the investigators aim to determine if LBW~     individuals exhibit decreased subcutaneous adipose tissue expandability, postprandial~     hyperlipidaemia and ectopic fat accumulation when exposed to 4 weeks of carbohydrate~     overfeeding. The investigators will subsequently examine if exercise training can revert~     and/or minimize the deleterious effects of carbohydrate overfeeding in a possibly birth~     weight differential manner.~   "
44649|NCT02982395|"~     The purpose of this study is to determine whether Nanoxel®M is effective in the treatment of~     patients with recurrent Ta and T1 who experienced treatment failure with at least one prior~     BCG intravesical treatment.~   "
44650|NCT02982382|"~     The burden of low back pain more than doubled in the last 20 years, probably caused by~     biopsychosocial factors. Some noninvasive treatments have been applied in individuals with~     chronic nonspecific low back pain as spinal manipulation and pain education. However, it is~     not already clear the neurophysiological effects of these treatments.The purpose of this~     research is to verify the effects of the technique of spinal manipulation and pain education~     in individuals with chronic low back pain~   "
44651|NCT02982369|"~     This study aims to investigate the effects of vertebral manipulation and pain education on~     subjects with neck pain. For this purpose, 90 subjects who present chronic neck pain will be~     selected and allocated randomly into 2 groups: vertebral manipulation group and pain~     education group.~   "
44652|NCT02982356|"~     The risk of abnormal chromosome and structure is much higher in twins than in singletons, and~     traditional early pregnancy screening strategy for single pregnancy is not suitable for~     twins. Based on our management experience of fetal medicine at twin pregnancy, and~     multi-center cooperation, the study will carry out the following clinical studies:~        1. to explore a suitable, early, noninvasive and accurate prenatal screening strategy for~          twin pregnancy.~        2. fetal chromosomal abnormalities~   "
44653|NCT02982343|"~     Charcot Marie Tooth (CMT) is the most common inherited neuropathy. It affects the nerves of~     the hands and feet first, slowly progressing towards the centre of the body. It causes~     varying degrees of weakness and reduced feeling, usually affecting the feet and ankles first.~     High incidence of falls and knock on effects in quality of life are common. This is a~     lifelong condition which, though not life limiting, does not have a cure. Research into the~     effect of balance rehabilitation in people with CMT has been limited to traditional~     exercises, which do not address the complex nature of balance impairments in this condition.~     Multi-sensory rehabilitation has proved beneficial in improving balance in people with~     sensory neuropathy. Research shows that strengthening trunk muscles can improve balance in~     older people. Trunk and muscles close to it are largely unaffected in people with CMT,~     therefore these muscles could be strengthened in these patients. This study proposes to~     assess the feasibility of multi-sensory balance training, strength training with a focus on~     the trunk and muscles close to the trunk, and falls management education. This comprehensive~     approach is reflective of a clinical physiotherapy programme. Though a life-long condition,~     many people with CMT lead full lives. A home based programme is proposed to so that patients~     can fit it into their lives without having to travel for treatment. Therapists will use~     self-management principles within treatment. Measurements will be taken prior to and~     following treatment including physical measures, questionnaires and interviews. The~     physiotherapy interventions will be taught home and data collection will be at the National~     Hospital for Neurology and Neurosurgery, University College London Hospitals (UCLH).~   "
44654|NCT02982330|"~     Large glucose excursions at breakfast are prevalent in type 2 diabetes and can contribute to~     sustained hyperglycaemia across the day. Lowering consumption of dietary carbohydrate is~     known to reduce post-meal glucose excursions but it is unknown whether lowering the~     carbohydrate at breakfast only will impact subsequent post meal glucose excursions throughout~     the day. The aim of this study is to examine, under free living conditions and using typical~     dietary patterns, whether eating a breakfast low in carbohydrate can lower daily post-meal~     glycemia when compared to consuming a low-fat breakfast (per the current diabetes~     guidelines).~   "
44655|NCT02982317|"~     A novel automated ultrasound software system has been developed which identifies for the~     practitioner the intervertebral spaces in the lumbar area. This study aims to investigate~     whether this new technology has a greater accuracy of identifying intervertebral spaces that~     manual palpation.~   "
44656|NCT02982304|"~     Dystonia is increasingly being considered as a multi-nodal network disorder involving both~     basal ganglia and cerebellar dysfunction. The aim of this study is to determine if~     Multi-Target Thalamic and Pallidal Deep Brain Stimulation improves hemi-dystonia patients~     who are receiving inadequate therapy from GPi DBS.~   "
44657|NCT02982291|"~     Lumbar spinal stenosis with neurogenic claudication is a common condition in the elderly~     population and is characterized by bilateral buttock, thigh, or calf discomfort and/or pain,~     as well as by weakness precipitated by walking and prolonged standing. Self-management~     options include physical therapy, which includes exercise as a core component for improving~     the flexibility and mobility of the spine and hips. A Williams flexion protocol has~     historically been used to treat low-back pain following degenerative changes to the posterior~     elements of the lumbar spine. However, few studies have been done to validate the efficacy of~     this protocol. A more focused treatment protocol may be more efficacious. Patients in this~     study will be randomized to receive either the generic physical therapy protocol (15~     sessions) or the focused rehabilitation program (5 sessions). The sessions will take place~     over the course of 6 months. Outcomes will be assessed using validated questionnaires and~     physical function tests.~   "
44658|NCT02982278|"~     This research project will evaluate the relationship between cardiovascular risk factors,~     degrees of physical and mental activity prior to the stroke, brain tissue integrity,~     post-stroke community participation and neurological recovery after the stroke. Investigators~     will recruit and study healthy and post stroke participants, gaining insight into the~     possible mechanisms that explain why the adverse risk profile, which is more commonly present~     in African-Americans than non-Hispanic Whites in the stroke belt, is translated into a less~     favorable recovery post stroke.~   "
44659|NCT02982265|"~     Pre-eclampsia is a heterogeneous multisystem disorder that complicates 2-8% of pregnancies~     and remains a leading cause of maternal and perinatal mortality and morbidity.~      Pre-eclampsia is defined as new onset of hypertension (defined as a diastolic blood pressure~     ≥ 90 mm Hg and a systolic blood pressure ≥ 140 mmHg on at least two different recordings~     taken at least 4-6 h apart and less than 7 days apart, using an appropriate cuff) and~     substantial proteinuria (defined as excretion of protein ≥300 mg in 24 h or a protein~     concentration ≥ 300 mg/L or ≥ 1 + on dipstick in at least two random urine samples taken at~     least 4-6 h apart but no more than 7 days apart) at or after 20 weeks of gestation.~      Pre-eclampsia only occurs in the presence of placenta and is resolved by delivery of the~     same. However, the underlying causes of the disease remain largely unknown.~   "
44660|NCT02982252|"~     Losing the ability to walk can lead to fewer opportunities to socialize with friends and~     family and participate in the community. When this happens, powered wheelchairs can provide~     access to homes and communities, contributing to health and well-being. Training by a~     qualified occupational therapist allows an individual to use a powered wheelchair safely and~     effectively. Learning to drive a powered wheelchair can be difficult, frustrating and time~     consuming for people with cognitive and physical challenges. In this study, the investigators~     will ask participants with cognitive impairments to complete training with an occupational~     therapist using either a shared control wheelchair or training methods according to the~     standard of care. The investigators believe shared control training, entitled Collaborative~     Powered mobility Innovative Learning OpporTunity (CoPILOT) will enhance driving skill while~     maximizing safety learning. CoPILOT has the potential to enable people to participate more in~     their day to day lives and regain mobility independence.~   "
44661|NCT02982239|"~     Evidence suggests that student athletes frequently experience sleep problems and are aware of~     the impact of sleep loss on mental and physical outcomes. As such, student athletes are~     motivated to improve sleep quality in order to improve their outcomes for overall athletic~     performance. This study will consist of two parts. The first part will be a survey. Fall~     athletes arrive in the summer, and Part 1 will invite 200 of these athletes to complete a~     survey within the first week of their arrival on campus. The survey will assess multiple~     domains of student-athlete health, namely, sleep duration and quality, mood and depression,~     stress, and mental and physical well-being. The responses to the survey will be confidential,~     and students will be compensated for the survey. At the end of the semester, students will be~     invited to complete the survey again.~      Part 2 is an intervention. 40 of the 200 students will be chosen to participate in the~     intervention, based on predetermined criteria. The intervention will include an information~     session where students may ask questions. Students will be sent text message reminders about~     adherence to the program and will be asked to monitor their sleep quality with sleep diaries.~     The intervention will consist of the half of the 40 chosen students, (20 students), who will~     be provided with blue blocking glasses, a bright light-emitting diode (LED) light, and a fit~     bit. Please note that all of these items are commercially available and are not meant to be~     used to treat or prevent human illness nor injury and do not require FDA oversight. The~     blue-blocking glasses will ensure that blue light from electronic devices will not interfere~     with circadian rhythm or sleep onset, and allow students to fall asleep earlier. The bright~     LED light will provide bright blue light in the morning to help students wake and an amber~     light to promote earlier bedtimes. The Fitbit will estimate sleep and physical activity as~     well as adherence to the program.~   "
44662|NCT02982226|"~     The objective of this clinical trial is to evaluate both the safety and efficacy of the ReNu™~     injection on pain and inflammation in subjects diagnosed with plantar fasciitis as compared~     to a Corticosteroid Injection which is considered standard of care.~   "
44663|NCT02982213|"~     The purpose of the study is to evaluate if maternal anxiety is improved when a parturient~     gets her choice with regard to the presence of a companion during epidural catheter placement~     for labor analgesia. It will be focused on parturients having their first child with the~     current partner. Additionally, it will investigate the effect of ethnicity, health literacy~     (as evaluated by the Newest Vital Sign questionnaire), catastrophizing (as evaluated by the~     Pain Catastrophizing Scale), and the relationship of the support person to the parturient.~     The investigators hypothesize that there may be specific subgroups in which maternal anxiety~     is improved when a parturient gets her choice regarding the presence of a companion during~     labor epidural catheter placement; however, a significant improvement in maternal anxiety,~     when including all participants, will not be appreciated.~   "
44664|NCT02982200|"~     A global prospective, multi-center, single-arm, post-market clinical follow-up (PMCF) study~     conducted to assess the performance of the Medina Embolization Device when used in unruptured~     and ruptured intracranial aneurysms.~   "
44665|NCT02982187|"~     This is a randomized, multi-centre, open-label, placebo-device, cross-over study, with a 2x2~     complete block design in subjects with chronic obstructive pulmonary disease (COPD) to assess~     the benefits of delivering triple therapy using a single ELLIPTA dry powder inhaler (DPI)~     (closed triple therapy) versus delivering triple therapy using two different types of DPI~     (open triple therapy). The primary objective of the study is to evaluate the proportion of~     COPD subjects who make critical errors when using a single ELLIPTA DPI versus those using~     combinations of DISKUS® with HANDIHALER®, or TURBUHALER® with HANDIHALER. At Visit 1, all~     subjects will demonstrate the use of ELLIPTA DPI, and HANDIHALER DPI in combination with~     either DISKUS DPI (in sub-study 1) or TURBUHALER DPI (in sub-study 2), based on the treatment~     sequences. At the end Visit 1, subjects will complete the inhaler preference questionnaire~     (PQ). There is no active treatment and subjects will continue to take their own prescribed~     COPD medication for the duration of the study. ELLIPTA and DISKUS are registered trademarks~     of the GSK group of companies; TURBUHALER is a registered trademark of AstraZeneca and~     HANDIHALER is a registered trademark of Boehringer Ingelheim Pharma GmbH & Co. KG.~   "
44666|NCT02982174|"~     Compare the signal to noise ratio of each device at various retinal layers.~   "
44667|NCT02982161|"~     The MR308-3501 study is a multicenter, randomised, double-blind, parallel-group study in male~     and female adult subjects to demonstrate the efficacy of MR308 in the treatment of acute~     moderate to severe pain after the extraction of at least two third molars requiring bone~     removal.~   "
44668|NCT02982148|"~     This study is designed to compare the effectiveness of intradermal injection and subcutaneous~     injection with methylene blue for early-stage breast cancer patients who need sentinel lymph~     node biopsy.~   "
44669|NCT02982135|"~     The investigators conducted a prospective multi-center study assessing the effect of direct~     bypass and indrect bypass in treatment of hemorrhagic moyamoya disease.~   "
44876|NCT02979431|"~     The primary objective is to evaluate the anti-viral effect and safety of different doses of~     inhaled ALX-0171 in subjects hospitalized for Respiratory Syncytial Virus Lower Respiratory~     Tract Infection (RSV LRTI). The secondary objective is to evaluate the clinical activity,~     pharmacokinetic (PK) properties, pharmacodynamic (PD) effect and immunogenicity of different~     doses of inhaled ALX-0171.~   "
44670|NCT02982122|"~     Despite improvements in management, mortality in severe traumatic brain injury (TBI) remains~     25% and only 40% of patients survive without major handicap. Medical/surgical interventions~     aim to maintain adequate brain perfusion, which is critically dependent on cerebral perfusion~     pressure (CPP); calculated as the difference between mean arterial pressure (MAP) and~     intracranial pressure (ICP). Current guidelines aim for a CPP above 50 mmHg, based on~     population means. However, this 'one size fits all' approach is flawed, because the relation~     between CPP and brain perfusion varies between individuals. Further, this approach takes no~     account of autoregulation, a key protective mechanism that maintains cerebral perfusion~     despite CPP fluctuations.~      Autoregulation is variably preserved following TBI, and there are large between patient~     variances in the 'optimal' CPP (CPPopt) at which autoregulation operates best. Individual~     CPPopt can be retrieved automatically by plotting autoregulation data against the CPP over a~     certain time window. The investigators have shown that maintenance of CPP close to CPPopt is~     associated with improved outcomes. These data pose the hypothesis that optimisation of~     management in individuals may be achieved by using the zone of optimal autoregulation as a~     basis for defining individualised CPP targets.~      The investigators propose, together with collaborators in the CPPopt study group (Maastricht,~     Cambridge, Leuven and Aachen) to set up a pilot (multicenter) feasibility study to develop a~     protocol for a definitive outcome randomized controlled trial (RCT). This study aims to~     develop protocols for CPPopt guided critical care, and show that they maintain patients~     closer to their optimum perfusion levels than standard protocols which keep above a~     population CPP threshold of 60 mmHg.~      Hence, the main objective is to offer clinicians monitoring and therapy algorithms that~     achieve individualized optimal CPPopt targets and potentially improve TBI outcome.~   "
44671|NCT02982109|"~     The investigators have recently reported a relationship between pain induced by peripheral~     venous cannulation and postoperative pain. The purpose of this study is to validate this~     method of postoperative pain prediction in a larger cohort subjected to different types of~     surgery.~   "
44672|NCT02982096|"~     The purpose of this study is to determine if healing occurs within 21 days of treatment with~     the use of the CellutomeTM device for fractional epidermal micro grafting compared with~     standard acellular techniques (creams and membrane dressings).~      Healing will be determined by time to ≥90% epithelialization within 21 days of treatment.~     Cosmesis (as assessed by Vancouver Scar Scale (VSS), Patient Observer Scar Assessment Scale~     (POSAS), erythema, pigmentation, elasticity, thickness, and sensation) will be compared to~     standard techniques without application of skin cells (epidermal grafts = acellular) and will~     be measured twelve months post treatment application, ± 6 months.~   "
44673|NCT02982083|"~     The investigators select 40 postmenopausal women suffering from RA with 2.5<DAS28<5.5~     referring to rheumatology clinics of Mashhad university of medical sciences and randomly~     divide them into intervention group and placebo group. Evista tab 60mg/day and placebo are~     administered double blind. In the beginning, total bone mineral density (BMD) assessment is~     carried out from all patients and then Alendronate is discontinued in 2 groups. In first 3~     months, in addition to Evista and placebo, MTX tab 2.5mg is given to patients and they are~     allowed to consume NSAID with accurate record of its dosage. Patients visit rheumatologist~     monthly in these 3 months and NSAID should be discontinued 48 hours before every visit. At~     the end of month 3, disease activity and probable complications are evaluated and compared in~     2 groups. Classic regimen should be started for every patient who doesn't enter remission~     phase in first 3 months.~      In 4th month, DMARD regimen is administered and then patients are visited every 2 months.~     Clinical findings are collected in month 0, 1, 2, 3, 6, 8, 10, 12. After 12 months, another~     total BMD test is carried out and then data are analyzed including changes in BMD, DAS28,~     EULAR response criteria and HAQ-DI score.~   "
44674|NCT02982070|"~     The aims of this study are to (1) assess the extent of psychological distress for incoming~     first-year students at the University of Tulsa (Part 1), (2) assess the impact of mental~     toughness training on the trajectory of psychological well-being and academic success (Part~     2), (3) assess the impact of mental toughness training on neural and behavioral reactivity to~     affective stimuli and decisions (Part 3), and (4) examine genetic markers of resiliency in~     college populations and interactions between genetic markers and response to mental toughness~     training (Part 2).~   "
44675|NCT02982057|"~     The aim of the present study is to compare the evolution of non culprit lesions after~     treatment by BVS versus optimal medical therapy at 2-years follow- up~   "
44676|NCT02982044|"~     The purpose of this study is to determine if different blood flow patterns change artery~     function. We hypothesize that the temporary induction of an oscillatory blood flow pattern~     will result in an immediate improvement in artery function. Participants will be asked to~     come to the Vascular Dynamics Lab (IWC E102) at McMaster University for a total of 3 visits.~     The first visit will allow the participant to get comfortable with the lab and the upcoming~     tests; and the next 2 visits will be scheduled at the same time of day to collect data. For~     visits 2 and 3, participants will be asked to arrive after a 4 hour fast. At these visits,~     ultrasound imaging will be used to examine the arteries and how they may change when blood~     flow patterns through an artery in the arm are changed. To change blood flow in the arm,~     heat, rhythmic squeezing of the forearm with a cuff, or handgrip exercise will be used. These~     interventions will be applied to the left forearm, from the elbow to the fingertips. A~     trained technician will also draw a blood sample during both data collection visits. A total~     of 10 participants will be recruited for the entire study.~   "
44677|NCT02982031|"~     The primary objective of this study was to compare ultrasound visibility of the lumbar plexus~     at the intertransverse space between paramedian transverse scan and shamrock technique.~     Moreover obtaining a clear image of relevant structures is imperative. Thus, the secondary~     objective was to assess ultrasound visibility of each relevant structure and overall~     visibility between these two methods.~   "
44678|NCT02982005|"~     The primary objective of this study is to evaluate the efficacy and safety of KHK4827 in~     subjects with moderate to severe plaque psoriasis randomized in a double-blind manner to~     receive KHK4827 or placebo for 12 weeks~   "
44679|NCT02981992|"~     In this observational study, the investigators evaluated the Treg number and function in a~     population of patients undergoing hemodialysis (HD).~      In particular, the investigators considered the relationship of Treg cell status with the~     different HD modalities and clinical parameters.~   "
44680|NCT02981979|"~     The purpose of this study is to investigate the efficacy and Safety of Leflunomide in~     Patients With Active Phase of Takayasu's Arteritis~   "
44681|NCT02981966|"~     Researchers hope to determine the organ (liver and/or kidney) responsible for the increase in~     endogenous glucose production (EGP) following the induction of glucosuria (when glucose is~     excreted in detectable amounts in the urine) with an SGLT2 inhibitor, dapagliflozin.~   "
44682|NCT02981953|"~     The current management of tricuspid regurgitation (TR) is either conservative (by medication)~     or by surgery, usually in concomitant with other valves repair or replacement. TR can worsen~     or appear late after successful mitral valve surgery which portends a poor prognosis~     .However, standard surgical approaches requiring cardiopulmonary bypass and especially second~     surgery have an excessive risks. Thus many patients are denied surgery because of unfavorable~     risk-benefit balance. Therefore there is a need for novel devices enabling interventional~     cardiologists and cardiothoracic surgeons to perform tricuspid annuloplasty by transcatheter~     methods. Cardioband replicates established surgical techniques (e.g., annuloplasty) using~     transfemoral approach, without sutures and with adjusted on the beating heart. Similar to the~     approved indication for mitral annuloplasty. The Cardioband System is expected to allow for~     treatment of patients that would otherwise not undergo Tricuspid valve repair due to the~     invasiveness of current techniques.~      The Cardioband Transcatheter System (Cardioband) is a marketed system that was approved for~     treatment of secondary (functional) mitral regurgitation (FMR) (CE granted on September~     2015). The Cardioband is an annuloplasty band that is similar to a surgical annuloplasty,~     however deployed on the beating heart through a transvenous approach. The CE mark study with~     30 subjects has been completed and documented significant reduction of severity of MR and~     improvement in quality of life by Minnesota living with heart failure questionnaire (MLHFQ),~     Ney York Heart Association (NYHA) and 6- minute walk test (6MWT), in subjects with moderate~     to severe MR. The aim of the current study is to evaluate the Cardioband annuloplasty system~     for repair the Tricuspid Regurgitation.~   "
44683|NCT02981940|"~     This research study is studying a targeted therapy as a possible treatment for recurrent~     glioblastoma (GBM).~      The following intervention will be used in this study:~      -Abemaciclib~   "
44684|NCT02981927|"~     To evaluate the early metabolic responses (whole body and within muscle tissue) to a single~     day of whole body physical inactivity (i.e. bed-rest), and evaluate the contribution of~     inactivity per se vs alterations in diet~   "
44685|NCT02981914|"~     This pilot study has been designed to investigate the safety of pembrolizumab treatment for~     disease relapse following allogeneic stem cell transplant (alloSCT). Pembrolizumab will be~     administered at a fixed dose of 200 mg IV every 3 weeks. Approximately 12-26 patients with~     relapsed MDS, AML, or mature B cell (B-NHL, cHL) malignancies that have relapsed following~     alloSCT will be enrolled on this trial. Pembrolizumab treatment will be administered for up~     to 24 months, provided that neither disease progression, nor development of a dose-limiting~     toxicity (DLT), has occurred. Adverse events will be monitored every three weeks throughout~     the trial and graded in severity according to the guidelines outlined in the NCI Common~     Terminology Criteria for Adverse Events (CTCAE) version 4.0. This trial will be conducted in~     accordance with Good Clinical Practices.~   "
44686|NCT02981901|"~     No structured organization for ovarian first line management emerges in France. Management~     across France seems to depend on regional contexts.~      Regions display no specific organization or delineate regional network for the ovarian cancer~     management or report centralized management revolving around referent centers. These~     different templates present a major problem in identifying differences, costs and benefit.~      To deal with this issue the Investigators propose a health economic evaluation based on~     cost-effectiveness analyses, completed with a budget impact analysis. This study will~     investigate the cost-effective management of patients with initial ovarian cancer using~     databases representative of different parts of French territories.~   "
44687|NCT02981888|"~     The purpose of this study is to find out the relationship between the bile acids, fatty acids~     (fatty acids are part of the diet) and bacteria that are present in the intestines.~   "
44688|NCT02981875|"~     Children with reading eye movement problems were recruited for this study. The treatment~     group was provided with oculomotor training for 8 weeks, the control group was given placebo~     exercises.~   "
44689|NCT02981862|"~     The current project is based on the assumption that a diagnosis of human papillomavirus~     associated Infiltrating Carcinomas can be made from a blood sample for patient with Cervical~     Cancer, Vulvar Cancer, Anal Cancer or Oropharynx Cancer at any stage of the disease and~     including surgical treatment for the small tumors.~   "
44690|NCT02981849|"~     The purpose of this study is to address the needs for efficient and informative measurement~     for evaluating adolescent Screening, Brief Intervention, and Referral to Treatment (SBIRT)~     strategies. The investigators will undertake a longitudinal cohort study to build and~     validate a substance specific measurement battery that includes patient-centered and~     intermediary outcomes which can be integrated into a range of healthcare and research~     settings. The results of this project will enable evaluation of SBIRT trials and clinical~     efforts by validating a parsimonious set of measurement tools that can be incorporated into~     electronic health records. The primary goal of the proposed project is to develop a set of~     brief, valid tools that will allow both researchers and clinicians to collect information~     that enables evaluating and refining brief interventions.~      The main objective is to define and disseminate a set of brief and easy to administer~     measures that accurately detect 1) substance use frequency, 2) substance-specific patient~     centered outcomes and 3) intermediate measures of impact of adolescent SBIRT. The specific~     aim addressed in this project is to develop and administer an assessment battery that~     includes novel questions assessing substance use to be validated against criterion standard~     measures both cross-sectionally and longitudinally.~   "
44691|NCT02981836|"~     The purpose of this study is to evaluate the protective effect, safety and immunogenicity of~     a live attenuated varicella vaccine in healthy children.~   "
44692|NCT02981823|"~     To provide information on reducing the incidence of periprosthetic fractures during hip~     replacement with the CFP prosthetic stem by analyzing the risk factors for periprosthetic~     fractures and their effects on hip functional recovery.~   "
44693|NCT02981810|"~     To evaluate coblation channeling treatment for chronic tonsillitis. Does Tonsillar ablation~     can create changing in the tonsillar medium for recurrent tonsillar infections and stop the~     recurrent infections?~   "
44877|NCT02979418|"~     This study will implement the validated household-level water insecurity scale developed by~     study investigators among a cohort of postpartum women in Nyanza, Kenya and will assess a~     range of outcomes linked to water insecurity, such as viral load, hydration status, maternal~     depression, stress, food insecurity, and cognitive development.~   "
44694|NCT02981797|"~     This is a prospective biomarker study on prostate cancer patients receiving Radium 223 as~     standard of care.~      Participants will take part in this research study because they have chosen Radium 223~     treatment for their prostate cancer that has spread to the bone and causing pain.~     Investigators want to find out if a blood test performed before and after the Radium 223~     treatment will help to understand how prostate cancer cells react to this therapy.~      In this pilot study, researchers want to find out if Radium 223 given as part of standard~     treatment for prostate cancer can decrease the number of circulating prostate cancer cells.~     Radium 223 kills prostate cancer cells by damaging their DNA. Other than looking at the~     changes in the number of circulating prostate cancer cells before and after Radium 223,~     researchers would also like to look at the changes in a DNA damage marker, called gamma H2AX,~     in the circulating prostate cancer cells before and after treatment with Radium 223.~     Assessing the DNA damage marker gamma H2AX is investigational. It is performed in the same~     tube of blood that is used for assessing the changes in the number of circulating prostate~     cancer cells.~   "
44695|NCT02981784|"~     Effective treatment options for chronic myeloid leukemia (CML) or Philadelphia-positive (Ph+)~     acute lymphoblastic leukemia (ALL) patients with the T315I mutation are few. This study~     compared overall survival (OS) between CML and Ph+ ALL patients treated with ponatinib versus~     allogeneic stem cell transplantation (allo-SCT).~   "
44696|NCT02981771|"~     Individuals of advanced age with cardiovascular disease are at higher risk of fall.The aim of~     this study is to explore the effect of specific exercise program based on balance and~     coordination on stability parameters~   "
44697|NCT02981758|"~     A comparison of reported estimated blood loss with quantified blood loss in all patients~     whose medical records indicate Triton was used during their vaginal delivery.~   "
44698|NCT02981745|"~     This is a phase I study of BTK inhibitor CT-1530 in patients with relapsed or refractory B~     cell non-Hodgkin lymphoma (B-NHL), chronic lymphocytic leukemia (CLL) or Waldenstrom's~     macroglobulinemia (WM).~      The purpose of the study is to determine the MTD/RP2D of CT-1530, and evaluate its safety and~     tolerability as monotherapy in subjects with relapsed or refractory B cell non-Hodgkin~     lymphoma (B-NHL), chronic lymphocytic leukemia (CLL) or Waldenstrom's macroglobulinemia (WM).~   "
44699|NCT02981732|"~     For nearly 112 million patients with osteoporosis in China, it is of great significance for~     preventing and treating by clearly understanding the molecular mechanism of kidney~     deficiency. Thus, the research group has demonstrated in the earlier research that CLCF1 is~     an associated gene that can regulate JAK2/STAT3 signal pathway and impact bone metabolism for~     kidney yin deficiency of postmenopausal osteoporosis (PMOP). To make clear understanding of~     the direct-acting mechanism of CLCF1 for bone metabolism, this study intends to: ①observe~     impacts of low expression of CLCF1 upon immunities in mice and OPG/RANKL/RANK signal system~     using the technology of adenovirus associated virus. ②explore impacts of over-expression and~     silencing of CLCF1 on B lymphocytes by culcuturing the cells together with osteoblasts. ③~     analyze the impacts of treating kidney yin deficiency of PMOP by Liuwei Dihuang pill upon~     immunities and OPG/RANKL/RANK system, and discuss the mechanism of regulating bone metabolism~     by CLCF1 by OPG/RANKL/RANK system via the bridge between immune system and bone metabolism,~     so as to demonstrate if the hypothesis of this study that the molecular osteoimmunological~     mechanism of kidney yin deficiency of postmenopausal osteoporosis (PMOP) is possibly closely~     related to the impacts of CLCF1 regulation of OPG/RANKL/RANK signal system on bone~     metabolism is right or not.~   "
44700|NCT02981719|"~     The aim of this study was to observe the survival status, recurrence and death time of~     patients with pancreatic cancer treated by chemotherapy combined with IRE. The survival and~     overall survival of the patients were evaluated respectively.~   "
44701|NCT02981706|"~     This is a pilot, single-center, randomized trial of 90 subjects to evaluate complication~     rates and functional status decline in subjects age 70 years and older referred for vascular~     access placement. Subjects will be randomized to arteriovenous fistula (AVF) (n = 45) versus~     arteriovenous graft (AVG) (n = 45), placed in a vascular access monitoring protocol, and~     undergo measurements of functional status including gait speed, grip strength, and~     self-reported function over 6 months. The primary hypothesis to be tested is that AVF~     placement will result in a higher proportion of primary access failure as defined by a binary~     composite primary endpoint of an unsalvageable access or an immature access or a~     non-functional access measured at 6 months compared to AVG placement. In addition, the study~     will evaluate whether AVF placement and a greater number of access procedures will result in~     a greater decline in functional status as measured by the average change over 6 months in~     gait speed, grip strength, and self-reported function as assessed by the Disabilities in Arm,~     Shoulder and Hand Survey.~   "
44702|NCT02981693|"~     The purpose of this study was to evaluate the clinical and radiological outcomes of iRoot SP~     as a root canal sealer in comparison with AH Plus sealer within 1-year follow up.Patients~     needing root canal treatment were enrolled and allotted into either iRoot SP group or AH Plus~     arm randomly. After root canal shaping and cleaning, the teeth were obturated according to~     their arms. Assessment of postoperative pain was done 1 week after root canal obturation~     using visual analog scale. After 1-year follow-up, clinical and radiographic evaluations were~     carried out. Statistical analysis at P < 0.05 was conducted to measure difference between the~     arms.~   "
44703|NCT02981680|"~     Background:~      Acute kidney injury (AKI) following coronary artery bypass graft (CABG) surgery is a major~     complication occurring in 1% to 53% of patients (depending on how it is defined) with the~     pooled rate of 18.2% and unfortunately 2.1% of them require renal replacement therapy.~     Cardiopulmonary bypass (CPB)-associated AKI increases mortality 2-4 fold regardless of AKI~     definition. It is also associated with increased risk of postoperative stroke, acute~     myocardial infarction, cardiac tamponade, heart failure, and lengthened intensive care unit~     and hospital stays. Even minor elevations of postoperative serum creatinine (SCr) have been~     associated with a significant increase in 30-day mortality, from a 3-fold increase risk for a~     small elevation of up to 0.5 mg/dL from baseline to an 18-fold increase risk of death with a~     SCr rise greater than 0.5 mg/dL.~      The pathogenesis of CPB-associated AKI is complicated and includes hemodynamic, inflammatory~     and other mechanisms that interact at a cellular level. To date, despite several clinical~     trials of pharmacologic interventions, none of them have demonstrated conclusively efficacy~     in the prevention of AKI after cardiac surgery.~      Remote ischemic preconditioning (RIPC) is a phenomenon in which brief ischemia of one organ~     or tissue, provokes a protective effect that can reduce the mass of infarction caused by~     vessel occlusion and reperfusion. In CABG surgery, cardiomyocyte injury caused by myocardial~     protection failure is predominantly responsible for adverse outcomes. RIPC was shown to~     reduce troponin release 24 h postoperatively in children undergoing corrective surgery for~     congenital heart disease. Other studies demonstrated that RIPC using brief ischemia and~     reperfusion of the upper limb reduces myocardial injury in adult patients undergoing CABG~     surgery.~      Due to the similarities between the mechanisms of ischemia-reperfusion injury produced by~     RIPC and those proposed for AKI after CPB, we decided to test the hypothesis that RIPC~     prevents AKI in patients undergoing CABG surgery.~      Methods:~      180 patients who fulfill all inclusion and exclusion criteria will be divided into case and~     control groups (90 patients in the case and 90 patients in the control group).~      Patients in the treatment group will receive three sequential sphygmomanometer cuff~     inflations on their right upper arm after induction of anesthesia in the operating room. The~     cuff will be inflated by the OR nurse up to 200 mmHg for five minutes each occasion, with~     five minutes deflation in between inflations. Following this pre-conditioning phase, surgery~     will be started. The entire pre-conditioning phase will last 30 minutes.~      Patients in the control group will have the sphygmomanometer cuff placed on their right upper~     arm, but the cuff will not be inflated. Similar to patients in the treatment group, patients~     in the control group will undergo the same 30 minute delay before starting surgery.~      Complete blood count (CBC), SCr, liver function test (LFT), will be checked before surgery.~      After surgery, SCr will be checked daily. If AKI occurs, it will be managed and dialysis will~     be done if the patient requires it. All patients will undergo electrocardiogram and LFT after~     CABG surgery during hospital course.~   "
44704|NCT02981667|"~     Previous research is equivocal concerning if high intensity interval training is viewed as~     more aversive versus moderate exercise. Our data in active men and women showed that interval~     training is viewed as more enjoyable than higher volume moderate exercise.~   "
44705|NCT02981654|"~     This is a prospective, open-label, multi-center, non-comparative study that will be conducted~     on female subjects between 30 and 75 years of age, diagnosed with stress urinary incontinence~     (SUI).~      Following the screening period, including urodynamic assessment to confirm SUI, each subject~     will undergo three FemiLiftTM treatment sessions, and will be followed up for a period of one~     year. The main efficacy endpoint in this study is defined as significant improvement (score~     of 6 or 7) in the urinary incontinence measured with PGI-I score at the 6 months visit.~     Various subjective and objective measures of incontinence severity, quality of life, sexual~     function and tissue effects will be performed at follow up.~   "
44706|NCT02981641|"~     The purpose of this study is to find the better radiation therapy between intraoperative~     radiotherapy (IORT) and concurrent chemoradiotherapy (CCRT).~   "
44708|NCT02981615|"~     Infections are a major and prevalent life-threatening complication among patients with~     myelodysplastic syndrome (MDS). Currently, the role of prophylactic antibacterial agents~     after chemotherapy in MDS patients remains controversial and there are no clinical guidelines~     for infection prophylaxis in this clinical setting. We will conduct a prospective study to~     evaluate the potential benefit of prophylactic antibacterial (Levofloxacin) on the rate of~     febrile episodes/infections in Azacytidine treated MDS patients.~   "
44709|NCT02981602|"~     To examine the safety and tolerability of IONIS-HBVRx administration to treatment-naive~     patients with chronic hepatitis B virus infection~   "
44710|NCT02981589|"~     The main purpose of the present study was to explore the weaning failure rate from invasive~     mechanical ventilation and to identify risk factors of weaning failure.~   "
44711|NCT02981576|"~     Spinal Cord Injury (SCI) is a devastating condition that leads to permanent functional and~     neurological deficits in injured individuals. The limited ability of the Central Nervous~     System (CNS) to spontaneously regenerate impairs axonal regeneration and functional recovery~     of the spinal cord. The leading causes are motor-vehicle crashes, sports-associated~     accidents, falls, and violence-related injuries.~      Unfortunately, there is still no effective clinical treatment for SCI. In recent years,~     tissue engineering and regenerative medicine based approaches have been proposed as~     alternatives for SCI repair/regeneration. Mesnchymal stem cells (MSC) use in SCI showed~     promising results in several studies. Our aim is to assess and compare the safety and~     effectiveness of autologous BM-MSC vs autologous AT-MSC in these patients.~   "
44712|NCT02981563|"~     The aim of this project is to test and evaluate a nursing intervention, Time Together (TT),~     created to enable quality interactions between patients and staff in psychiatric inpatient~     care. The research questions are:~      Does TT influence the quality of interactions between staff and patients? Does TT influence~     patients' levels of anxiety and depressive symptoms? Does TT influence staffs' levels of~     perceived stress and levels of stress of conscience? Does TT influence the prevalence of~     coercive measures, mean length of hospital stay and the use of PRN medication?~      In parallel, a process evaluation will be conducted, answering questions such as:~      How do staff and patients describe their experiences of the intervention and how do~     contextual factors influence the effects of the intervention? What are the relationship~     between the outcome variables and the degree of compliance with the intended intervention?~     What problems are there with recruitment and dropouts?~   "
44713|NCT02981550|"~     The purpose of this feasibility study is to test a device which analyzes breath and may allow~     doctors and health professionals to immediately determine if an ill patient has a specific~     type of bacterial infection. This will allow a health professional to provide immediate~     targeted antibiotics to properly start treatment without delay.~   "
44714|NCT02981537|"~     The purpose of this study is to find a novel method for placing endobronchial blockers~     without fiberoptic guidance to provide one-lung isolation during anesthesia for thoracic~     surgery.~   "
44715|NCT02981524|"~     This study will be looking at the objective response rate (ORR) as measured by RECIST in in~     patients with mismatch repair-proficient (MMR-p), advanced colorectal cancer that treated~     with CY/GVAX in combination with Pembrolizumab.~   "
44716|NCT02981511|"~     Optiflow can be used to prolong the apnoea period under anaesthesia without falls in blood~     oxygen saturation. This study is designed to assess whether the Optiflow system can~     efficiently replace conventional anaesthetic mask and circuit preoxygenation so that it could~     be used in emergency anaesthesia. If so, it would be then be in place in the case of~     difficult or failed intubation to maintain oxygenation ie: it could preoxygenate and then~     maintain oxygenation seamlessly.~   "
44717|NCT02981498|"~     To evaluate safety and efficacy of combined hepatic arterial infusion (HAIC) of oxaliplatin,~     5-fluorouracil and leucovorin and sorafenib in patients with advanced hepatocellular~     carcinoma (HCC).~   "
44718|NCT02981485|"~     Breast cancer related lymphedema (BRCL) is a common complication following breast cancer~     treatment. The incidence of BRCL ranges from 6-50%, depending on the surgical procedure in~     the axilla and the type of the radiation therapy. BRCL can causes cosmetic deformities,~     impaired physical mobility, mental discomfort, reduced quality of life and erysipelas.~     Therapy of BRCL is divided into conservative and operative methods. However, all the above~     method has some shortcomings. It is urgent to investigate new approaches to treat BRCL. In~     this study, fat grafting is to be used for the treatment of BRCL, and the efficacy and safety~     of this method will be also assessed.~   "
44719|NCT02981472|"~     To investigate the safety and pharmacokinetics of apixaban in children with congenital or~     acquired heart disease who have a need for anticoagulation.~   "
44720|NCT02981459|"~     The specific purpose of this study is to provide objective data in prospective open label~     design (n=40) to support the use of Mirabegron as a treatment for pain related urinary~     frequency and urgency. Women with bladder pain have a poor response to traditional~     anticholinergic therapy for their symptoms of frequency and urgency.~   "
44721|NCT02981446|"~     The purpose of this study is to investigate the intraocular pressure-lowering effect and the~     safety of DE-117 ophthalmic solution compared with Latanoprost ophthalmic solution in~     subjects with open angle glaucoma or ocular hypertension.~   "
44734|NCT02981277|"~     Flexible bronchoscopy is one of the most widely performed procedures for diagnosis of various~     bronchopulmonary diseases. Most patients tolerate the procedure well although cough is often~     reported as a distressing symptom. It is likely that the acceptance of bronchoscopy would be~     significantly improved with control of cough. Use of sedation during bronchoscopy has been~     reported to improve procedure tolerance. However, awake(no sedation) bronchoscopy is~     routinely performed at many centres including ours.~      Topical lignocaine is administered during bronchoscopy for local anaesthesia. There is~     limited literature on the efficacy of transtracheal/transcricoid injection versus spray as~     you go method for lignocaine delivery to the airways during bronchoscopy. This study would~     help to determine the procedure comfort for the patient while using the~     transtracheal/transcricoid method vs the spray as you go method.~   "
45629|NCT02969603|"~     The present study is conceived as a pilot study aimed to determine the efficiency of the~     newly available Positron Emission Tomography (PET) - Magnetic Resonance Imaging (MRI) hybrid~     scan technique for muscular activity evaluation, creation of anatomic images of muscle~     activity and resolution of metabolic activity distribution within exercising skeletal muscle.~   "
44722|NCT02981433|"~     Vulvodynia is a syndrome of unexplained vulvar pain that is frequently accompanied by~     physical disabilities, limitation of daily activities (such as sitting and walking), sexual~     dysfunction and psychologic disability. Originally suggested by McKay, the term vulvodynia~     has also been suggested by the International Society for the Study of Vulvar Disease Task~     Force to describe any vulvar pain. The incidence and prevalence of vulvodynia have not been~     well studied. Age distribution for the condition may range from the 20s to the 60s, and it is~     limited almost exclusively to white women. Obstetric and gynecologic history is usually~     unremarkable. Risk-taking sexual behavior is rare, and few patients have a history of~     sexually transmitted diseases. Vulvar pain usually has an acute onset, at times associated~     with episodes of vaginitis or certain therapeutic procedures of the vulva (cryotherapy or~     laser therapy). In most cases, vulvodynia becomes a chronic problem lasting months to years.~     Vulvar pain is frequently described as burning or stinging, or a feeling of rawness or~     irritation.~      Most patients consult several physicians before being diagnosed. Many are treated with~     multiple topical or systemic medications, with minimal relief. In some cases, inappropriate~     therapy may even make the symptoms worse. Since physical findings are few and cultures and~     biopsies are frequently negative, patients may be told that the problem is primarily~     psychologic, thus invalidating their pain and adding to their distress.~   "
44723|NCT02981420|"~     A youth's contact with the juvenile justice system represents an opportune moment for suicide~     screening and brief suicide intervention for indicated youth. This study will provide data on~     the novel implementation of an evidence-based brief suicide intervention, safety planning,~     administered by front-line juvenile court staff for suicidal court-involved non-incarcerated~     youth. Data will inform the dissemination and implementation of suicide brief interventions~     to be delivered by front-line staff at the time of mental health screening in the juvenile~     justice system. The proposed study is consistent with the NIMH Strategic Plan by testing an~     intervention for effectiveness in community settings (Strategy 3.3) and establishing a~     research-practice partnership to improve D&I of evidence-based MH services (4.2). The unique~     service delivery by JJ court staff also supports the NIMH goals to develop innovative service~     delivery models (Strategy 4.3) as well as validate a MH intervention for an underserved~     population (Strategy 4.1). This proposal also addresses the Healthy People 2020 goals of~     reducing suicide attempts (MHMD-2).~   "
44724|NCT02981407|"~     The purpose of this study is to compare two red blood cell transfusion strategies (liberal~     and restrictive) for patients who have had an acute myocardial infarction and are anemic.~   "
44725|NCT02981394|"~     The use of Bone Marrow Autologous Collection (BMAC) in musculoskeletal conditions including~     osteoarthritis and tendon injuries has been growing. Outcome evidence continues to be sparse.~     The purpose of this study is collect a longitudinal case series of patient reported outcomes~     following BMAC injections for musculoskeletal conditions including osteoarthritis,~     tendinopathy and injuries to ligaments, tendons and muscles.~   "
44726|NCT02981381|"~     The investigators propose a small, two-site, sham-controlled pilot study of synchronized~     Transcranial Magnetic Stimulation (sTMS) in patients with comorbid post-traumatic stress~     disorder (PTSD) and depression. It is hypothesized that sTMS will be effective for PTSD and~     mood symptoms.~   "
44727|NCT02981368|"~     This study evaluates the safety and diagnostic performance of 18F-DCFPyL Injection in~     patients with at least high risk prostate cancer who are planned for radical prostatectomy~     with lymphadenectomy (Cohort A) or in patients with locally recurrent or metastatic disease~     willing to undergo biopsy (Cohort B).~      Cohort B is complete and no longer recruiting subjects.~   "
44728|NCT02981355|"~     This multi-centre randomized, controlled trial will assess the impact of BST-CarGel scaffold~     with microfracture versus microfracture alone on short and long term clinical benefit in~     patients with cartilage lesions of the femoral condyle requiring operative management.~   "
44729|NCT02981342|"~     The purpose of this study is to evaluate the safety and efficacy of abemaciclib alone and in~     combination with other drugs versus standard of care in participants with previously treated~     metastatic pancreatic ductal adenocarcinoma (PDAC).~   "
44730|NCT02981329|"~     The purpose of this study is to determine whether metformin is effective in the treatment for~     sickle cell anemia (SCA) and non-transfusion dependent thalassemia (NTDT).~   "
44731|NCT02981316|"~     The purpose of this study is to demonstrate the efficacy and safety of RBX7455 for the~     treatment of recurrent CDI in subjects who have had at least one recurrence after a primary~     episode (i.e., at least two episodes) and have completed at least two rounds of~     standard-of-care oral antibiotic therapy.~   "
44732|NCT02981303|"~     Objective: To determine the Overall Response Rate (ORR) to Imprime PGG + pembrolizumab in~     subjects with advanced melanoma or metastatic TNBC~      Safety: To characterize the safety of Imprime PGG + pembrolizumab given in combination~      Hypothesis: Restore (for melanoma) or enhance (for TNBC) sensitivity to checkpoint inhibitors~     (CPI) by appropriate and effective stimulation of the subject's innate and adaptive immune~     systems in those subjects who have failed 1st line therapy~      The study will incorporate Simon's optimal 2-stage design with sample size fixed at 12~     subjects each in Stage 1 for advanced melanoma and for Triple Negative Breast Cancer (TNBC)~     subjects. The safety criterion of ≤ 4 (or ≤ 33%) subjects with Grade 3/4 adverse events in~     Cycle 1 within either tumor type must be met in order to proceed to Stage 2. The starting~     dose is 4 mg/kg for Imprime PGG. In the event there are a total of > 4 (or > 33%) of subjects~     with Grade 3/4 adverse events in Cycle 1, the dose of Imprime PGG will be reduced to 2 mg/kg,~     and Stage 1 will be repeated at a dose of 2 mg/kg with an additional cohort of n=12 subjects.~     For the dose that meets the safety criterion in Stage 1, at least 1 response in melanoma~     subjects and 2 responses in TNBC subjects amongst the 12 subjects within each tumor type must~     be observed in order to proceed to Stage 2.~      Stage 2 will enroll an additional 17 subjects with melanoma, and 30 subjects with TNBC. For~     the dose that meets the Stage 1 safety criterion, success will be declared if at least 4~     amongst the total of up to 29 subjects with melanoma, and 13 amongst the total of up to 42~     subjects with TNBC achieve an objective response.~   "
44733|NCT02981290|"~     This is a single center, randomized, open label, 4-treatment, 4-period, 4-sequence, 4-way~     crossover study to compare the pharmacokinetics of mycophenolate mofetil (MMF) metabolites~     from 4 tablet formulations in healthy participants.~   "
44735|NCT02981264|"~     Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS -TBNA) is commonly~     performed for diagnosis of mediastinal pathologies. The procedure can either be performed~     under general anaesthesia or under moderate sedation with topical anaesthesia. Most patients~     tolerate the procedure well although cough is often reported as a distressing symptom.~     Topical lignocaine is administered during endobronchial ultrasound for local anaesthesia.~     There is limited literature on the efficacy of transtracheal/transcricoid injection versus~     spray as you go method for lignocaine delivery to the airways during EBUS-TBNA. This study~     would help to determine the procedure comfort for the patient while using the~     transtracheal/transcricoid method vs the spray as you go method.~   "
44736|NCT02981251|"~     The purpose of the study is to evaluate the effect of health education on blood pressure~     reduction compared to usual care among uncontrolled hypertensive patients of suburban~     community of Surkhet district of Nepal.~   "
44737|NCT02981238|"~     The aim of the study is to evaluate the effect of a one-month supplementation with~     Phytostandard® Eschscholtzia and valerian on the Insomnia Severity Index (ISI), in insomniac~     so-called adjustment subjects (occasional or short-term insomnia)~   "
44738|NCT02981225|"~     The purpose of the study is to describe, over 6 weeks, the evolution of depressive symptoms~     in patients with mild to moderate major depression in a strategy with Phytostandard®~     Rhodiola-Saffron supplementation~   "
44739|NCT02981212|"~     The purpose of this clinical study is to evaluate the efficacy and safety of that test group~     was administered with Mycophenolate Mofetil in combination with corticosteroid in patients~     with advanced IgA nephropathy. The control group will be observed for up to 48 weeks without~     administration of Mycophenolate Mofetil.~   "
44740|NCT02981199|"~     Comparison of the efficacy and safety of microtransplantation and autologous transplantation~     in the treatment of ≥PR multiple myeloma patients, 2-year PFS and OS were also been observed.~     To identify the role of microtransplantation in the treatment of multiple myeloma.~   "
44741|NCT02981186|"~     The study is a prospective randomised controlled study. The patients get monolateral IOL~     implantation of POD F GF and POD F in the contralateral eye. Both IOLs are trifocal IOLs~     consisting of the same optical design. The difference between the IOLs is the material~     (hydrophilic and hydrophobic).~      To decide which eye receives POD F and which eye receives POD F GF, a randomization table~     will be provided to the principle investigator.~   "
44742|NCT02981173|"~     The purpose of this study is to investigate the effects of an oral psilocybin pulse regimen~     in cluster headache. Subjects will be randomized to receive oral placebo, low dose~     psilocybin, or high dose psilocybin in three experimental sessions, each separated by 5 days.~     Subjects will maintain a headache diary prior to, during, and after the pulse regimen in~     order to document headache frequency and intensity before, during, and after the pulse~     regimen.~   "
44743|NCT02981160|"~     The purpose of the research is to determine energy expenditure rates and diet and/ physical~     activity metabolic features of an individual using current state technologies and a new~     technology created at the Center for Bioelectronics and Biosensors at ASU. This is a pilot~     study which intent is to validate this device for use in the weight loss patient population.~      This study will involve research of metabolic physiological parameters that are measured~     through the breath of the individuals, together with other physical parameters (weight,~     height, date of birth, fat and lean body composition via bio-impedance, heart rate, blood~     pressure, and breathing rate) assessed in the clinic, and a questionnaire about diary~     physical activities. The study will involve withdrawn of breath samples at resting~     conditions, and under diets or physical activities regimes.~      This instrument will assist our patients in terms of tailoring their diet/nutrition through~     their weight loss journey prior and after surgery. As a new technology, it will be an~     excellent tool for compliance assessment and engagement with the Weight Loss Program as well~     as for long term follow up.~   "
44744|NCT02981147|"~     The purpose of this study is to investigate the efficacy of Phytus in Acute Cough~   "
44745|NCT02981134|"~     The purpose of this study is to evaluate usefulness of coronary computed tomographic scan for~     prediction of clinical events after everolimus-eluting bioabsorbable scaffold implantation~     for coronary artery disease.~   "
44746|NCT02981121|"~     The investigators will study prevention effect of Life style modification on diabetes~     mellitus comparing with conventional management and Metformin administration.~   "
44747|NCT02981108|"~     This is a Phase 1/2, open-label, multicenter study of HS-10296 with dose escalation, dose~     expansion and extension cohorts in locally advanced or metastatic non-small-cell lung cancer~     (NSCLC) patients who have progressed following prior therapy with an epidermal growth factor~     receptor(EGFR) tyrosine kinase inhibitor (TKI) agent. The study is designed to evaluate~     safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of once-daily and orally~     (PO) administered HS-10296. The overall study design is shown in the flow chart below, which~     consists of 3 phases: dose escalation, dose expansion and extension cohort.~   "
44748|NCT02981095|"~     Investigators aimed to evaluate the impact of bupivacaine administration into the surgical~     field after total thyroidectomy on post-operative pain and analgesic requirement with a~     double-blind, prospective, clinical, randomized study.~      Pain assessment was performed with the visual analog score (VAS). Participants were~     pre-operatively, divided into two groups randomly to receive either bupivacaine or not. One~     group received a 10 ml of bupivacaine solution while the other group was treated with the~     same volume of 0.9% sodium chloride (NaCl) through the drain after completion of total~     thyroidectomy procedure. All participants were anesthetized and operated with the same~     anesthesia and surgical team.~   "
44749|NCT02981082|"~     A double-blinded, placebo-controlled study of Dimethyl fumarate (DMF) in 34 Systemic~     Sclerosis-Pulmonary Hypertension (SSc‐PAH) patients. The study will determine safety and the~     primary outcome variability for DMF in treating SSc‐PAH; the primary outcome of clinical~     efficacy in this pilot trial will be improvement in 6‐minute walk distance (6MWD).~   "
44750|NCT02981069|"~     In this study, the researchers hope to learn about SGLT2 inhibition on EGP (endogenous~     glucose production) and plasma glucose concentration in diabetic subjects. Researchers will~     examine diabetes and the role of increased plasma glucagon, decline in plasma insulin, and~     fall in plasma glucose concentration.~   "
45953|NCT02965365|"~     This study aims to find out whether diagnosis of Transient Tachypnea of the Newborn(TTN) can~     be predicted via evaluating pulmonary artery Doppler indices.~   "
44752|NCT02981043|"~     Clinical studies so far have been limited, and larger volume and multi-center studies studies~     are needed. The purpose of this pilot study is to look for a clinical correlations between~     the aggressivity panel developed from biomarkers thought to affect the progression or~     aggressivity of endometriosis, pain and quality of life.~      Our goal with the study is find a correlation between the aggressivity of endometriosis~     with clinical factors determined in our study questionnaires. The aggressivity panel was~     pioneered by the EndoDiag lab in France, and was created using markers thought to affect the~     activity or progression of endometriosis. This information could lead to a better~     understanding of the disease, and ultimately lead to more targeted therapies.~      If a patient returns for a second surgery we will ask their permission to use their slides~     from their first and seconed surgery to compare. The tissue that is being removed during the~     surgery as standard of care to make slides for the research study (there will not be an~     endometrial biopsy performed for research purposes with the second surgery). The slides from~     surgery 1 & surgery 2 will then be compared.~      If a clinical correlation is found with the aggressivity panel, the goal would be to create a~     local lab and tissue bank here in the United States that could provide a basis for~     collaborative national (even international) research. Also, if a correlation is found, future~     investigation will look at correlations of the aggressivity panel and fertility outcomes.~     Results of this pilot study will help to direct studies of treatment protocols of the various~     stages of aggressivity of endometriosis.~   "
44753|NCT02981030|"~     The study will examine how a simplified outpatient medical abortion procedure using~     mifepristone and misoprostol, with the option to take mifepristone at a place of woman's~     choosing, works in Ukraine. The investigators intend to demonstrate the efficacy of oral~     administration of 200 mg mifepristone and buccal administration of 800 mcg misoprostol with~     gestations through 70 days, as well as the acceptability of this method.~   "
44754|NCT02981017|"~     We propose a randomized, single-blinded, prospective trial in order to evaluate the efficacy~     of the Cook Biodesign ENT Repair graft in improving outcomes after the Draf III or Endoscopic~     Modified Lothrop procedure. The Cook Biodesign ENT Repair graft is a porcine intestinal~     submucosal xenograft which has been FDA approved for use as an adjunct to natural healing~     process in the sinonasal cavity. The Draf III or Endoscopic Modified Lothrop involved~     creating a large unified drainage pathway for refractory frontal sinusitis. After the~     procedure is completed, there is exposed bone along the frontal beak region which can become~     a nidus for inflammation, crusting and eventual scarring, leading to stenosis or even~     complete blockage of the frontal sinuses. The Cook Biodesign will be used to cover this~     exposed bone in order to potentially reduce the inflammation, crusting and scarring and~     possibly improve outcomes.~   "
44755|NCT02981004|"~     The Prosthesis-to-Annulus Relation I (PAR I) trial is a German multicenter study assessing~     the relation between the prosthetic GOA and the area of LVOT as potentially new parameter for~     the prediction of hemodynamic outcome. The results may possibly guide future valve size~     selection an may allow prediction of functionally relevant PPM (Patient-Prosthesis-Mismatch)~   "
44756|NCT02980991|"~     The study is a prospective, single-center, open-label, single-armed, phase II clinical trial.~     The aim of the study is to evaluate the radiological response rate (RR) of 2 cycles of~     neoadjuvant chemotherapy with pemetrexed and cisplatin in patients with resectable stage II~     and IIIA lung adenocarcinoma.~   "
44757|NCT02980978|"~     This study aims to randomly assign individuals with type 2 diabetes into the ENHANCED~     randomized control trial. The study is being conducted by the Minneapolis Heart Institute~     Foundation (MHIF) and will have two study sites 1) Hutchinson Health and 2) New Ulm Medical~     Center. The study is primarily funded through the Academy of Nutrition and Dietetics (AND).~      The study will examine the impact of a registered dietitian-led, primary care integrated,~     telemedicine program on diabetes care measures (the 'D5') over one year as compared to usual~     care. The D5 goals include: blood pressure <140/90 mmHg, taking a statin as appropriate, A1c~     <8%, not using tobacco and taking an aspirin as appropriate.~   "
44758|NCT02980965|"~     This was an open-label, randomized controlled trial that aims to compare the efficacy and~     safety of the concurrent neoadjuvant chemotherapy with endocrine therapy and neoadjuvant~     chemotherapy alone in ER-positive, HER2-negative breast cancer.~   "
44759|NCT02980952|"~     The aim is to assess the impact of physical inactivity on muscle amino acid balance. In~     addition, we will evaluate how the diet and/or a pharmacological intervention designed to~     manipulate lipid metabolism (acipimox) will modulate muscle amino acid balance.~   "
44760|NCT02980939|"~     During exercise in the heat, there is a need to replenish fluids in order to avoid~     dehydration and decrease the risk for heat illness. What drives this urge to drink is the~     thirst mechanism. Following ingestion of fluids, there is an inhibition of thirst before~     there is a replenishing of fluids. However, there is little scientific evidence of where~     thirst is inhibited, if this thirst inhibition is augmented by exercise and how thirst itself~     influence exercise performance. Further, during rehydration studies, it is very difficult to~     successfully blind a subject to their drinking/hydration protocol. Previous studies that have~     blinded a subject to their drinking have used various methods such as intravenous fluid~     administration and/or nasogastric tubes. Therefore, the purpose of this research is to~     examine the mechanistic roles thirst inhibition plays while exercising in the heat while~     undergoing intravenous fluid administration. Specific attention will be directed to the~     cardiovascular and thermoregulatory function of the individuals. All blood, cardiovascular,~     thermoregulatory, and perceptual measures are shown in the diagram below.~   "
44761|NCT02980926|"~     The purpose of this study is to determine if a shorter-acting spinal anesthetic called~     mepivacaine has advantages over a longer-acting medication called bupivacaine.~   "
44762|NCT02980913|"~     Dry eye syndrome is a highly prevalent ocular disease with an increasing incidence in the~     elderly population.~      Topically administered lubricants are the basis for treatment of this disease. Relief of~     symptoms in patients with moderate to severe dry eye disease is usually reached by the use of~     artificial tears during the day. Nighttime relief is often achieved by substances known to be~     more adhesive to the ocular surface, such as gels.~   "
44763|NCT02980900|"~     The present study will assess the effect of the type and timing of protein ingestion 6 days~     prior to, and 7 days following eccentric exercise on the time course of 1) the recovery of~     muscle function, 2) the recovery of perceived muscle soreness, 3) muscle metabolism.~   "
44764|NCT02980887|"~     It is recognized that patients with various forms of heart and lung disease exhibit varying~     degrees of pulmonary hypertension, pulmonary vascular remodeling, and right ventricular~     dysfunction. The genetic, molecular, and cellular processes driving these phenomena are not~     well understood. Rapid advances in high throughput omic methodology, combined with powerful~     bioinformatics and network biology capability, have created the opportunity to conduct~     studies that broadly search for homologies and differences across the spectrum of disease~     states associated with pulmonary hypertension, and determinants of the spectrum of right~     ventricular compensation that accompanies these conditions~   "
44765|NCT02980874|"~     This is a Phase 3, multicenter, randomized, masked, controlled, parallel group study of 12~     months duration in treatment naïve subjects with RVO.~   "
44766|NCT02980861|"~     Splenic hilum remains challenging during total gastrectomy with D2 lymphadenectomy.The~     application of minimally invasive surgery for advanced gastric cancer is gaining popularity.~     The investigators aim to compare the safety and feasibility of LTG and OTG for advanced~     proximal gastric cancer.~   "
44767|NCT02980848|"~     This Breast Cancer Surveillance Consortium (BCSC) ADVANCE study is a large, observational~     pragmatic comparative effectiveness research study using high-quality, prospectively~     collected data from BCSC registries to generate evidence on how breast density should be~     integrated into decision making around breast cancer screening and preoperative diagnostic~     work-up. We will augment existing BCSC registry infrastructure with additional prospective~     data collection and collection of patient reported outcomes (PROs), CISNET modeling of~     long-term screening outcomes, and qualitative data from focus groups with women represented~     in two aims.~   "
44768|NCT02980835|"~     Intercostal nerve block, performed under the guidance of videoscope, is a part of standard~     anesthesia procedures for patients receiving Video-Assisted Thoracic Surgeries. In this~     double-blind, prospective, multi-center, randomized, controlled clinical trial the~     investigators aim to compare preemptive versus post-closure intercostal injection of~     ropivacaine in controlling post-video-assisted thoracotomy pain.~   "
44769|NCT02980822|"~     Purpose: The incidence of surgery for Degenerative lumbar Disc Disease (DDD). According to~     the national spine registries in Sweden, Norway and Denmark, there is a difference in~     surgical incidence between these countries. The cause for this difference is not known. It~     may reflect a difference in incidence of lumbar disc hernia, but with a similar~     socio-economic and ethnical background in these countries, it is more likely that the~     differences are due to varying surgical indications. Comparing indications for surgery,~     patient reported outcome and factors predictive for outcome after surgery for lumbar disc~     decease in these countries could provide information about optimal indications for surgery.~      Hypotheses: (i) there are no differences in patient-reported outcome after surgery between~     these countries, (ii) there are no differences in indications for surgery between these~     countries and (iii), factors that predict outcome are similar in these countries.~      Method of research: By using data from three Nordic national spine registers, investigators~     will compare baseline data, indications for surgery and patient reported outcome one year~     after surgery for lumbar disc decease. Register based studies have advantages such as large~     sample sizes, reflecting real life, but they also have limitations such as lower follow-up~     rates than clinical trials. A non-response analysis will be performed to take this into~     account.~   "
44770|NCT02980809|"~     The purpose of this study is to determine whether topotecan plus apatinib are superior to~     topotecan alone as second-line therapy in small-cell lung cancer.~   "
44771|NCT02980796|"~     Participants will complete 11 sessions. These include screening, 5 sessions where exercise or~     rest (according to group assignment) are paired with practice of a motor task, MRI and~     Transcranial Magnetic Stimulation (TMS) before and after the intervention will be used to~     assess neuroplasticity (ability for the brain to reorganize and create new connections).~   "
44772|NCT02980783|"~     This study will evaluate the effectiveness of Juvéderm® VOLIFT®™ with Lidocaine for dynamic~     radial cheek line skin depressions.~   "
44773|NCT02980770|"~     Obstructive sleep apnea (OSA) and Obesity-Hypoventilation Syndrome (OHS) are common~     conditions in obesity, which may influence the prognosis in patients undergoing surgery.~     There is a need for simple screening tools to identify such patients at high risk. The~     current multicenter observational study aims to investigate occurrence of OSA and OHS in~     obese individuals undergoing elective abdominal surgery and further address its impact on~     perioperative and postoperative complications.~   "
44774|NCT02980757|"~     The main purpose of this study is to assess comparative bioavailability of two test~     formulations of Gliclazide 120 mg Modified Release tablets (120 mg gliclazide per modified~     release tablet) Manufactured By Indeus Life Sciences Pvt. Ltd., Mumbai India (An Affiliate Of~     Disphar International B.V., The Netherlands) Relative To DIAMICRON MR® 60 mg 2 × (60 mg~     gliclazide per modified release tablet) Of Les Laboratories Servier Industrie, France in 15~     healthy adult subjects under fasting conditions. The second aim is to asses the safety of~     subjects and to determine other pharmacokinetic data.~   "
44775|NCT02980744|"~     The traditional approach to physical activity promotion in people with stroke has always~     emphasized activities of a moderate-to-vigorous intensity (i.e. moving enough to breathe fast~     and break a sweat). For many people with stroke who often have difficulty with walking,~     achieving that intensity of activity is difficult. The result is that people with stroke~     spend over 80% of their day in sedentary behaviours (too much sitting). A growing body of~     research shows that too much sitting has negative effects on health including larger waist~     circumference, unhealthy levels of blood glucose and insulin, heart disease, lower levels of~     functioning, and premature death.~      This project tests a new approach to activity promotion that focuses on increasing~     light-intensity activity throughout the whole day while reducing sitting time. The new~     intervention is titled STand Up Frequently From Stroke (STUFFS) and is aimed at increasing~     self-confidence among people with stroke to sit less, stand up and walk around at frequent~     intervals during the day. Studies in the general population have shown that standing up and~     walking around frequently are beneficially associated with health indicators (lower waist~     circumference, lower blood fat and glucose levels). Encouraging people with stroke to reduce~     sitting and increase light-intensity activities appears feasible and sustainable and might be~     a first step to increase their daily energy expenditure.~   "
44776|NCT02980731|"~     The purpose of this open-label, single-arm study is to evaluate the impact of venetoclax on~     the quality of life of participants including those with relapsed/refractory (R/R) chronic~     lymphocytic leukemia (CLL; a type of cancer affecting the blood and the bone marrow) with or~     without the 17p deletion or TP53 mutation, including subjects with an unknown status, as well~     as R/R CLL subjects who have been previously treated with B-cell receptor inhibitor therapy~     (BCRi). The starting dose of venetoclax is 20 mg once daily. The dose must be gradually~     increased over a period of 5 weeks up to the daily dose of 400mg. Participants may continue~     receiving venetoclax for up to 2 years. After the treatment period, participants may continue~     on into a 2-year follow-up period.~   "
44777|NCT02980718|"~     Awareness of the sense of smell in the western population has been low. Most people do not~     think about the consequences of absence of smell (anosmia). Reduction in sense of smell~     (hyposmia) can influence everyday life. In situations of stress anosmia can be life~     threatening for example when there is a fire. Cooks may lose their job. Not being able to~     enjoy food and drink interferes with quality of life. The causes of olfactory dysfunction~     (OD) vary. Most often OD is associated with upper respiratory tract infections, disease of~     the nose and sinuses or head injuries. OD may be congenital, age related or associated with~     neurological disorders. Hyposmia occurs in up to 85% of cases of Parkinson's and may be the~     first symptom of both Parkinson's and Alzheimer's disease several years before the mental~     changes occur.~      Knowledge and focus on OD has until recently been low among most physicians and treatment~     options have often not been available. Different approaches to improve OD have been tried~     with variable effect depending on the cause of OD. There are studies on corticosteroids, zinc~     gluconate and vitamin A. In recent years, olfactory training has been launched as a promising~     treatment option. Most studies with olfactory training are done with patients with OD. A~     recently published review describes 10 studies with olfactory training among 639 patients and~     concludes that daily stimulation with odorants (odor concentrate) over a limited period time~     is a promising treatment. The suggested duration of olfactory training varies from 3 to 14~     months. Different intensities of olfactory training were compared in patients with post-viral~     OD. Olfaction was more improved by the high concentration of odorant than by the low~     concentration.~      A small number of studies have shown that the olfactory nerve to some extent can be trained~     in persons with normal sense of smell, but we need more experience and structured studies to~     be able to conclude with greater certainty about the effect of olfactory training in this~     population.~      This study examines whether intensive olfactory training improves the sense of smell more~     than ordinary olfactory training in subjects with normal olfaction (normosmia) and examines~     self-evaluation of olfactory function.~   "
44778|NCT02980705|"~     This is a randomized, double-Blind, placebo-controlled Phase 2a study to evaluate the~     efficacy and safety of SUNPG1622.~   "
44779|NCT02980692|"~     This is a randomized, double-blind, placebo-controlled, multiple-dose, phase 2b study to~     demonstrate the safety and efficacy of SUNPG1623~   "
44780|NCT02980679|"~     A 99mTc Pertechnetate (G-PERT) scan is a nuclear medicine test that can create an image of~     the thyroid gland and other organs. G-PERT is approved by Health Canada for the direct~     imaging and measurement of thyroid uptake.~      Doctors and researchers at the University of Alberta have developed a new method of producing~     99mTc Pertechnetate (called CTC). It is made in a cyclotron at the Medical Isotope and~     Cyclotron Facility (MICF) at the University of Alberta, Edmonton, Alberta. This new~     production method will provide another source of 99mTc Pertechnetate. The aim of this study~     is to confirm that CTC is safe and can be used interchangeably with G-PERT.~   "
44781|NCT02980666|"~     The purpose of this study is to determine if an investigational treatment (teduglutide) is~     safe and effective in Japanese children (age 1 through 15 years of age) with SBS who are~     dependent on parenteral support. This study will also evaluate how teduglutide moves through~     the body (pharmacokinetics) and how it affects the body (pharmacodynamics).~   "
44782|NCT02980653|"~     Primary Objective:~      To evaluate the population prevalence of critical body weight loss ( more than 5% from~     baseline) in patients with Head and Neck cancer.~      Secondary Objectives:~      To evaluate the impact of appetite, and performance status; To evaluate the change of quality~     of life (QoL); To evaluate the incidence of infection and hospitalization; To evaluate the~     safety profiles~   "
44783|NCT02980640|"~     The Swiss Multiple Sclerosis Registry is a national, patient-centered registry with the aim~     to document the epidemiology of multiple sclerosis (MS), as well as the quality of life of~     persons living with MS in Switzerland.~   "
44784|NCT02980627|"~     Individuals with type 1 diabetes who intentionally omit insulin to lose weight are at high~     risk for diabetes-related medical complications and premature death. Conventional eating~     disorder (ED) treatments are not as effective for these patients, suggesting that they need a~     more tailored treatment approach and one that includes intervention at the time and place~     when they are making decisions about their diabetes self-management. The goal of treatment~     development project is to modify an existing mobile application (app) for EDs (Recovery~     Record; RR) to address the unique needs of adults with type 1 diabetes (T1D) who~     intentionally omit their insulin for weight control, and test whether app-supported~     individual treatment decreases eating disorder (ED) symptoms and improves metabolic control.~     The investigator will also gather preliminary data on the impact of the intervention on~     health care utilization and costs and calculate attrition to assess feasibility.~      The investigators hypothesize that (1) participants will evidence significant decreases in~     mean blood glucose, (2) participation in routine medical care will increase and emergency~     visits will decrease, (3) the percentage of time participants are hyperglycemic will~     decrease, (4) participant scores on the DEPS-R will decrease and (5) participant scores on~     the EDE will decrease.~   "
44785|NCT02980614|"~     MRI with 4D flow permits to assess the hemodynamic parameters in a parent vessel and its~     branches inside the same sequence. The objective of the project is to compare the regurgitant~     fraction in the pulmonary artery (PA) measured using 4D MR-flow and standard 2D MR-flow in~     repaired Tetralogy of Fallot (rTOF) patients. The consistency of the 4D flow quantization~     will be assessed assuming mass conservation in the pulmonary artery tree (PA flow =LeftPA~     flow +RightPA flow ? ).~   "
44786|NCT02980601|"~     The purpose of this research study is to compare the forearm free flap of patients with a~     traditional split thickness skin graft and those repaired with Integra (a skin substitute~     that helps to provide wound closure) and a split thickness skin graft. The study team will be~     looking at the subject's satisfaction with how the skin graft site looks and how well the~     skin graft site is functioning.~   "
44799|NCT02980432|"~     The investigators previously shown that a rotating optokinetic stimulus results in shifts of~     the subjective visual vertical in healthy human subjects. However, the origin of these shifts~     is still poorly understood. Both torsional displacement of the eyes and a shift in the~     internal estimate of direction of gravity have been proposed as potential explanations. Here~     the investigators use a vision-independent setup to differentiate between these two~     hypotheses, predicting no impact of a rotating stimulus on the subjective haptic vertical if~     torsion triggers the shift.~   "
44787|NCT02980588|"~     Poorly glycemic control in critically ill patients can increase their mortality, while safe~     and efficient glucose control is laborious and time-consuming. The Space Glucose Control~     which is installed with eMPC(enhanced Model Predictive Control) can get the blood glucose~     target range safely and effectively through regulating insulin dose rate, and decrease the~     glucose variability. This study is a random controlled trial involving the patients with~     sepsis in intensive care unit in order to evaluate the difference of safety and efficacy of~     blood glucose control between SGC directed and conventional treatment. At last, the trial~     results can determine whether the Space Glucose Control can control blood glucose safely and~     effectively in the patients with sepsis in intensive care units.~   "
44788|NCT02980575|"~     This study is aimed at determining whether listening to music during exercise will improve~     health-related outcomes for individuals with chronic obstructive pulmonary disease (COPD).~     Half of the participants will listen to music while they exercise and half will not listen to~     music. The study will follow participants during their pulmonary rehabilitation program and~     for 6 months following completion of the program.~   "
44789|NCT02980562|"~     Recently a low-volume polyethylene glycol containing ascorbic acid (PEG-Asc) formulation has~     proven as safe and effective as traditional 4-L PEG solutions for colonoscopy preparation.~     However, currently available aqueous purgative formulations are poorly tolerated. The aim of~     this study was to compare a split-dose 2-L PEG-Asc and a 1-L PEG-Asc with bisacodyl (10 mg)~     formulation to determine the quality of bowel cleansing and patient tolerability.~   "
44790|NCT02980549|"~     Emergence delirium (ED), also called emergence agitation or post-anesthetic excitement, is~     defined as a dissociated state of consciousness, occurring on awakening from general~     anesthesia, in which children exhibit psychomotor agitation, crying and thrashing and are not~     consolable for a period of time, usually 5-15 minutes. Emergence delirium is a common problem~     in pre-school children, with estimates of the incidence ranging from 10-70% of children in~     this age group. These children are agitated, seemingly unaware of their surroundings, and~     typically do not respond to parents or caregivers. They are therefore at risk for~     self-inflicted traumatic injury and complications secondary to disruptions of intravenous~     lines, surgical incisions, or drains. Children with ED typically require more resources in~     the postoperative period than children who do not exhibit ED. Predicting the likelihood of ED~     would allow for better allocation of resources in the post-anesthetic care unit (PACU).~      The peak incidence of ED in children occurs in the same age range at which the peak incidence~     of parasomnias (PS) occurs. The description of parasomnias is strikingly similar to the~     description of ED; the American Academy of Sleep Medicine defines parasomnias as undesirable~     physical events or experiences that occur during entry into sleep, within sleep or during~     arousals from sleep. Parasomnias can be diagnosed using a sleep questionnaire.~      The purpose of this pilot study is to determine the incidence of ED and PS in our population,~     in order to determine the number of patients necessary to enroll in a larger study to either~     confirm or reject the hypothesis that ED and PS are correlated.~   "
44791|NCT02980536|"~     The purpose of this study is to evaluate the mutation pattern of epidermal growth factor~     receptor (EGFR) and other TKI targeted gene during TKI treatment of advanced NSCLC patient~     with liquid biopsy.~   "
44792|NCT02980523|"~     A randomized, double blind, phase II multicenter trial whith the objetive of assess the~     safety and efficacy of the PRO-157 ophthalmic solution in three different dosing regimens,~     versus Moxifloxacin, versus Gatifloxacin in patients with bacterial conjunctivitis.~      Number of participants: 300 eyes, 60 per group.~      Criteria for evaluation:~      Measurements of effectiveness: Main efficacy criterion It will be determined as effective if~     there is a reduction in number or species of bacterial flora by comparing the basal culture~     against the final culture among the five different patient groups.~      Reduction or absence of infection with the clinical evaluation through signs and symptoms.~      Safety Measurements: it will be determined by visual acuity and adverse events Patients~     recruited will be treated for 7, for protocol purpose, the infected eye (s) will be taken~     into account at the time of baseline, however the study medication and procedures will be~     applied and performed in both eyes to protect the healthy eye.~      The study is divided into the following evaluation periods:~      Visit 1 baseline (day 1), visit 2 (day 3), final visit (day 8) and a telephone call (day 23)~     for the evaluation of adverse events.~      Subjects will be allocated to any of the following regimen dosages:~        -  PRO-157 1 drop 2 times daily~        -  PRO-157 1 drop 3 times daily~        -  PRO-157 1 drop 4 times daily~        -  Moxifloxacin 1 drop 3 times daily~        -  Gatifloxacin 1 drop 3 times daily. All regimen dosage will have a duration of 7 days. An~          artificial tear preservative free (Lagricel Ofteno®) will also be applied 15 minutes~          before instillation of study drug, during study period.~      Data Analysis: The data will be analyzed by Intention to Treat (ITT) and per Protocol (PP) in~     which each of the variables is described, the ITT population will be constituted by all~     subjects recruited who have received at least one dose of the study, the PP population will~     be the subset of ITT composed of all subjects without any major deviation from the protocol~     and the bivariate analysis will be performed in this group.~      Continuous quantitative variables are expressed and presented by measures of central tendency~     and dispersion (mean, standard deviation and ranges). Qualitative nominal and ordinal~     variables are presented by means of frequencies and proportions. The level of significance~     was an alpha of 0.05 or less.~   "
44793|NCT02980510|"~     National trial, multicenter, randomized, phase II assessing FOLFIRINOX + Panitumumab versus~     mFOLFOX6 + Panitumumab in metastatic colorectal cancer patients selected by RAS and B-RAF~     status from circulating DNA analysis.~      Evaluation of complete response rate on treatment combining FOLFIRINOX and panitumumab.~   "
44794|NCT02980497|"~     The objective of this randomized, single-center, examiner-blind, controlled, parallel group,~     six-month clinical study is to compare the antiplaque/antigingivitis potential of a~     no-alcohol essential oil containing mouthrinse and an alcohol essential oil containing~     mouthrinse. A negative control group using only an ADA Accepted anticavity toothpaste will be~     included.~   "
44795|NCT02980484|"~     This pilot study aims to investigate the efficacy of fMRI-targeted repetitive transcranial~     magnetic stimulation (rTMS) in treatment of major depression associated with traumatic brain~     injury (TBI). Half of patients will receive active treatment, while the other will receive a~     sham treatment with the option of receiving open-label active treatment afterwards.~   "
44796|NCT02980471|"~     The purpose of this study is to demonstrate the correlation of the Compensatory Reserve Index~     (CRI) numeric and graphical trend readings to intravascular volume changes as compared to~     graded blood loss (removal of 20% of estimated total blood volume in ~333 mL aliquots) and to~     stroke volume as measured by the Nexfin monitor during the same graded blood removal period.~     Enrollment includes both men and women.~   "
44797|NCT02980458|"~     The present study will be conducted in order to compare the bioavailability of the generic~     Test product (Deferiprone 500 Lipomed tablets, Lipomed AG, Switzerland) with a marketed~     Reference product (Ferriprox® film-coated tablets, Apotex Europe B.V., Germany) both~     containing 500 mg deferiprone. For this issue the pharmacokinetics will be characterised~     after single dose administration of each one tablet.~   "
44800|NCT02980419|"~     The long-term goal of this research is to advance the investigators knowledge of how the~     brain combines the information of multiple sensory systems coding for spatial oriention and~     how adaptation to vestibular imbalance influences spatial orientation. In healthy human~     subjects verticality perception is accurate while upright. After prolonged roll-tilt, humans~     show a systematic bias in perceived direction towards the previous roll-tilted position~     (so-called post-tilt bias). This effect could either be related to adaptation to the~     roll-tilted position (shifting the null position) or it could be related to changes in~     torsional eye position due to prolonged static roll-tilt (ocular counter-roll). While in the~     first case a post-tilt bias is predicted independently of the experimental paradigm used, the~     second hypothesis predicts a post-tilt bias only if retinal cues are integrated. In order to~     evaluate these hypotheses, the investigators will assess perceived vertical using both~     vision-dependent and vision-independent paradigms.~   "
44801|NCT02980406|"~     In this study, the investigators aim to assess the effect of acute FODMAP infusion on gastric~     motility and on gastrointestinal and psychological symptoms. 20 healthy volunteers and 20~     patients with irritable bowel syndrome (IBS) will undergo respectively four and two/three~     pressure measurements of the stomach after an overnight fast as a measure for gastric~     motility. During this pressure measurement, which takes approximately 4 hours, one of four~     FODMAP or control solutions will be administered directly into the stomach through a~     nasogastric tube. Administration will be stopped when the participant is fully satiated. The~     four solutions that will be tested in healthy volunteers are (1) a fructan solution, (2) a~     fructose solution, (3) a FODMAP mix and (4) a glucose solution as a control. In IBS patients,~     only the fructan and glucose solution will be tested, where after they can choose to come for~     a third visit to test the fructose solution. The solutions will be tested on separate~     occasions in a randomized order.~      During the pressure measurement, participants will be asked to complete several~     questionnaires: (1) a gastrointestinal symptom questionnaire to assess their gastrointestinal~     symptoms, (2) a satiation questionnaire during infusion of one of the solutions, (3)~     psychological questionnaires (POMS, SAM, PANAS and STAI) to evaluate possible psychological~     effects of FODMAP infusion.~      The investigators hypothesize that there will be differences in gastric motility between~     healthy volunteers and IBS patients. Furthermore, it is hypothesized that gastrointestinal~     symptoms will be increased in IBS patients, and that FODMAP infusion will have more~     psychological effects in patients than in healthy volunteers.~   "
44802|NCT02980393|"~     This study is to assess whether a lifestyle intervention with diet, exercise and counselling~     in young patients will have a positive influence on their weight and overall well-being. This~     study will enrol patients between the ages of 7 to 17 years of age, who have congenital heart~     disease, and have been identified being overweight or obese. A total of 40 individuals will~     participate in this study. The study duration will last for 1 year.~   "
44803|NCT02980380|"~     Despite partial success, communication has remained impossible for persons suffering from~     complete motor paralysis but intact cognitive and emotional processing, a state called~     complete locked-in state (CLIS).Very recently NIRS was successfully used to investigate the~     functional activations in the cortex of a CLIS patient in response to auditorily presented~     stimuli containing correct or incorrect statements and open questions. The hemodynamic change~     in the motor cortex of the CLIS patient was recorded across many sessions spread over more~     than a year and was used to train a classifier to predict the yes and no answering~     pattern of the CLIS patient who was previously trained to use an electroencephalography (EEG)~     based brain computer interface (BCI) without success. The trained classifier was able to~     provide online feedback (your answer was classified as (in) correct) to the patient with~     performance rate of 71.76%. This is the first carefully documented case of communication in a~     CLIS patient with BCI, which holds promise and raises the hope for communication in CLIS.~     Hence, to further validate the preliminary findings of our lab and refine the technology of~     functional near infrared spectroscopy (fNIRS)-based BCI for communication in CLIS-patients~     extensive studies will be carried out on CLIS patients using fNIRS based BCIs.~   "
44804|NCT02980367|"~     The primary objective of this study is to determine in patients with non-acute Anterior~     Cruciate Ligament Deficiency (ACLD) whether a strategy of non-surgical management~     [Rehabilitation] (with option for later ACL reconstruction, only if required) is more~     clinically effective and cost effective than a strategy of surgical management~     [Reconstruction].~   "
44805|NCT02980354|"~     Stroke is a life-threatening medical condition that occurs due to a sudden disruption of~     blood supply to the brain. Although it may affect all age groups including children, the~     elderly are at a greater risk of having strokes. Indeed, three-quarter of all strokes are~     seen in people over the age of 65. Unfortunately, due to short therapeutic window (4.5 h of~     stroke onset), only 2-3% of patients can receive the currently available single medical~     therapy with rt-PA, a clot-busting agent. As recent studies show that bone marrow-derived~     endothelial progenitor cells, a type of stem cells, may migrate to the site of injury to~     repair the damaged brain vessels and tissue, it is possible that their numbers and functional~     capacity may determine the clinical outcome of stroke patients i.e. severely disabled,~     moderately disabled or no signs at all. This study will assess these parameters in elderly~     stroke patients compared to their age-matched stroke-free counterparts and healthy young~     volunteers.~   "
44806|NCT02980341|"~     This is an open-label, three-part, non-randomized, multiple-dose study to evaluate safety,~     tolerability, and efficacy of U3-1402 in patients with HER3-positive metastatic breast~     cancer. HER3 is a unique member of the human epidermal growth factor receptor, which defines~     a certain type of cancer.~      The number of patients and treatment cycles are not fixed in this study. Subjects who~     continue to derive clinical benefit from the study treatment in the absence of withdrawal of~     consent, progressive disease (PD), or unacceptable toxicity may continue the study treatment~     until the end of the trial.~   "
44807|NCT02980328|"~     This study aims to evaluate the effectiveness of a self-therapeutic approach of skin adhesive~     low-level light therapy (LLLT) in females with Overactive Bladder (OAB) and Urinary~     Incontinence (UI)~   "
44808|NCT02980315|"~     The purpose of this study is to evaluate the safety of the designed LMP1－CAR －T cells and~     determine whether the CAR-T cells are effective in the treatment of EBV associated malignant~     tumors.~   "
44809|NCT02980302|"~     According to the World Health Organization (WHO), mental retardation (MR) is defined by an~     intelligence quotient (IQ) < 70 and touches between 1 to 3 % of the general population.~     Profound mental retardation (QI <25), severe (IQ: 25-40) and moderate (QI : 40-50) have a~     prevalence of 0,3-0,5% while the prevalence of mild MR, defined by an IQ between 50 and 70 is~     evaluated to about 1,5 %.~      The origin of MR can be infectious, toxic, traumatic, genetic or environmental. genetic~     causes of MR gather the number and structure anomalies of the chromosomes, the genomic~     microreorganization, monogenic diseases and more rarely other non Mendelian-inherited~     anomalies like print or epigenetic anomalies, mutations of the mitochondrial genome etc...~     Genetic causes represents 50% of moderate to severe, whereas environmental factors~     (malnutrition, cultural deprivation,...) plays an important role in mild MR.~      The main goal of this study is to get an innovative tool (neuronal distinction of iPSC) that~     wil allow to study the functionnal impact of mutations uppon genes probably involved in MR~     like MYT1L. The main criteria associated to characterisation of the tool by the trial is the~     study of the pluripotency of iPSC obtained and to highlight the mutation of the gene MYT1L in~     the iPSC.~      Neurons from the iPSC of the patient and his father du patient wille also be morphologically~     characterised, but also thanks to the expression of specifically neurals genes.~      Characteristics of iPSC and neurons from d'iPSC with MYT1L mutation will be compared among~     the patient and his father, in relation with the same cells coming from the two witnesses.~   "
44810|NCT02980289|"~     The study aims to investigate the prevalence and treatment of nausea and/or vomiting in~     patients with advanced cancer not receiving chemotherapy or irradiation.~   "
44811|NCT02980276|"~     The overall objective of the EMERGE trial is to determine whether metformin + usual care,~     compared to placebo + usual care (introduced at the time of initial diagnosis of GDM),~     reduces a) the need for insulin use, or hyperglycemia (primary outcome measure); b) excessive~     maternal weight gain; c) maternal and neonatal morbidities and, d) cost of treatment for~     women with Gestational Diabetes Mellitus.~   "
44812|NCT02980263|"~     The purpose of this trial is to evaluate whether, in Intravenous Immunoglobulin-naïve or~     refractory patients diagnosed with active Kawasaki disease, administration of canakinumab~     controls fever and acute phase reactants.~   "
44813|NCT02980250|"~     The purpose of this clinical multi-center study is to determine whether different doses of~     domperidone are effective in the treatment of feeding intolerance in premature infant~   "
44814|NCT02980237|"~     The objective this study is evaluate if an e-Health education program at the workplace to~     contributes to improve quality of life from Office Workers. And:Life style modification;~     Improve physical activity Reduces on Anthropometric Measures; Reduces Pain and discomfort in~     the musculoskeletal system~   "
44815|NCT02980224|"~     This is a phase 3 study to evaluate the safety and efficacy of OmegaD softgels for the~     treatment of dry eye disease. A daily dose of 2 OmegaD softgels dosed orally BID will be~     compared to 2 placebo softgels dosed orally BID for 84 days. Approximately 164 subjects will~     be evaluated for their signs and symptoms of dry eye disease and for safety throughout the~     study.~   "
44816|NCT02980211|"~     PURPOSE The purpose of this case series is to clinically, radiographically and histologically~     evaluate the treatment of dehiscence defects in extraction sockets using a minimally-invasive~     GBR technique that involves the application of a particulate bone allograft and a~     non-resorbable PTFE membrane.~      METHODS Subjects with single-rooted teeth indicated for extraction and interested in future~     implant therapy for tooth replacement will be recruited on the basis of an eligibility~     criteria. A buccal or lingual dehiscence defect must strongly be suspected or confirmed upon~     clinical examination in order for the subject to qualify for study inclusion. A cone-beam~     computer tomography (CBCT) scan of the arch containing the tooth to be extracted will be~     obtained prior to tooth extraction. Following minimally invasive tooth extraction and~     debridement, the socket will be evaluated to verify the presence of a dehiscence defect~     affecting at least 50% of the bony plate height. After creating a soft tissue 'pouch' using~     tunneling instruments, a non-absorbable dense-PTFE (dPTFE) barrier membrane that will be~     trimmed to a size and shape that would allow for complete extension over the existing defect~     will be tucked between the mucosa and the alveolar bone. Then, the extraction socket will be~     grafted with particulate allograft and the access to the socket will be sealed with an~     extension of the membrane and an external cross mattress suture. Subjects will be recalled at~     1, 2 and 5 weeks to monitor healing and assess the level of discomfort using a visual analog~     scale at the end of each visit. At the 5-week visit, the membrane will be gently removed and~     the exposed area will be left to heal by secondary intention. At 20 weeks after tooth~     extraction a second CBCT will be obtained to radiographically evaluate the site for implant~     placement. Bone volumetric reconstructions of the alveolar ridge at baseline and at 20 weeks~     will be made using the CBCT data to assess changes affecting the bone housing. If the site~     has healed adequately, implant placement will be planned at 24 weeks after tooth extraction.~     A bone core biopsy will be obtained at the time of implant placement in order to~     histologically analyze the characteristics of the grafted substrate. Upon implant placement~     with primary stability a healing abutment will be placed and sutures will be given to achieve~     primary wound closure, as necessary. Subjects will return for the final study visit at 2~     weeks following implant placement to evaluate the healing prior to being referred back to the~     restorative dentist.~   "
44817|NCT02980198|"~     This study is a Proof of Concept study aiming to evaluate the production of anti-IFNα~     antibodies (immune response) in adult subjects with dermatomyositis~   "
44818|NCT02980185|"~     To assess the feasibility, Residual Tumor, complication rate and survival of totally~     laparoscopic primary cytoreduction in carefully selected patients with Advanced Ovarian~     Cancer, compared with abdominal primary cytoreduction in a single-Institution, single-surgeon~     prospective series.~   "
44819|NCT02980172|"~     All patients admitted in Geneva University Hospitals (GUH) emergency department (ED) are~     triaged using the Swiss Emergency Triage Scale (SETS), a 4-level symptom-based triage scale.~     At the end of the triage process the triage nurse has to choose an emergency level and a main~     presenting complaint among a listing of 98 presenting complaints. The SETS recommends a pain~     evaluation for 44 out of the SETS 98 presenting complaint.~      The primary objective of the study is to determine whether pain is correctly evaluated when~     required by the SETS criteria. The secondary objectives are (1) to evaluate whether an~     appropriate treatment is delivered when pain is present, and (2) to identify predictors of~     pain evaluation and treatment.~   "
44820|NCT02980159|"~     Due to an increasing number of patients admitted in emergency departments, many patients~     cannot be evaluated immediately after their admission. The function of triage liaison~     physician was introduced in Spring 2015. The objective of this study is to evaluate the~     impact of this new function on patients' flow in the ED.~   "
44878|NCT02979405|"~     Hypotension in patients who are taken to surgery, is a very frequent complication, when the~     spinal anesthetical technique is used, associating this with significant adverse effects that~     can lead to morbidity specially in the obstetric patient. The objective of the study is~     determine if the phenylephrine used of prophylactic form, achieved to prevent the appearance~     of hypotension in obstetric patients led to Caesarea under spinal anesthesia.~   "
44821|NCT02980146|"~     Accumulating evidences suggest that colorectal cancer (CRC) progression is not solely~     determined by the genetic abnormalities of the tumor cells but also by the host response.~     Indeed, recent studies in CRC have associated improved survival with a high number of~     tumor-infiltrating (TIL) memory and cytotoxic T lymphocytes, suggesting a link between tumor~     progression and in situ T cell response. Gene expression profiling studies have clearly~     isolated a well-known subgroup of CRC characterized by microsatellite instability (MSI) CRC,~     associated with a strong immune response signature involving both Th1/cytotoxic and immune~     evasion pathways. Moreover, the investigators have previously shown that HLA-E/β2m is~     overexpressed by tumor cells in roughly 20% of CRC and is associated with a worse prognosis,~     most likely due to NK and T effector cell functions upon engagement with the inhibitory NK~     receptor CD94/NKG2A. However, our recent results on an enlarger cohort of patients suggest~     that if this observation holds true for MSS CRC, HLA-E over-expression is inversely~     associated with a good prognosis in MSI CRC. Thus, the phenotype and function of TIL,~     depending on the MSI/MSS status of CRC have to be precised. The investigators hypothesized~     that in MSI CRC, known to express a high number of MSI-H related frameshift peptides which~     represent a pool of tumor specific antigens, HLA-E could present peptides to TCR of non~     conventional CD8+ HLA-E-restricted alpha-betaT cells (also expressing CD94), then inducing a~     strong antitumor cytolytic activity. Therefore, the aim of this project is to determine the~     exact phenotype, function and specificity of the CD94+ TIL in CRC, depending on both the~     HLA-E and the MSI/MSS status of tumor cells. These results could impact the clinical practice~     as anti-NKG2A monoclonal antibodies or frameshift peptide based immunotherapy that could be~     promising new therapeutic options in CRC patients.~   "
44822|NCT02980133|"~     This study is to evaluate the safety and efficacy of Fluticasone Propionate and Fluticasone~     propionate Salmeterol in pediatric patients with a documented history of persistent asthma.~   "
44823|NCT02980120|"~     The proposed study will investigate whether, on the basis of personality traits and~     personality disorders as well as specific cerebral activation patterns shows differences in~     adolescent female with anorexia nervosa (AN), bulimia nervosa (BN) and a healthy control~     group.~   "
44824|NCT02980107|"~     The objective of this study is to evaluate the efficacy of infographics, compared to standard~     PLS format, in presenting information, in terms of understanding and remembering research~     results by consumers.~   "
44825|NCT02980094|"~     The project aims to study the effects of inclusion of sunflower oil, vitamin E and selenium~     in the diet of dairy cows on milk composition and the influence of modified milk on nutrition~     and health of elderly. To achieve those goals, two experiments will be conducted, both~     lasting 12 weeks. In the first one, 32 cows at the beginning of lactation will be allotted in~     a completely randomized block design with a 2 x 2 factorial arrangement of treatments, as~     follow: 1) control diet; 2) control diet plus selenium and vitamin E; 3) control diet plus~     sunflower oil diet; 4) control diet plus sunflower oil, selenium and vitamin E. This~     experiment seeks the development of modified milks through nutritional manipulation of cow's~     diet. Concomitantly, in the second experiment, 132 elderly people will receive the four~     different kinds of milk produced in the first experiment in a completely randomized block~     (gender) design. The selection of the elderly for each group shall be composed clinical~     evaluations. Will be conducted biochemical tests before and after supplementation of milk~     consumption (serum α-tocopherol, selenium, analysis of fatty acid profile). Assessment of~     nutritional status will be made body mass index (BMI) with each participant before and after~     the experiment of 12 weeks, including body composition by multifrequency bioelectrical~     impedance analysis (BIA), evaluating the strength of pressure of the hand portable~     dynamometer, demographics and food consumption. The study of human nutrition and health will~     be held in the form of a double-blind study. The second experiment aims to study nutrition~     and health of elderly people, as it is expected that milk produced with better fatty acid~     profile, vitamin and minerals can improve the inflammatory profile of markers of the elderly.~     This project is important for the human population in general, particularly elderly people,~     health workers, human and animal nutritionists, and especially for the milk chain, as it has~     a potential to develop new dairy products and boost milk consumption.~   "
44826|NCT02980081|"~     There are only few recognized indications for the realization of plain abdominal X-rays in~     the emergency departement.~      The objective of this study is to explore the reasons for abdominal plain X-rays prescription~     in the Emergency departments (EDs) of two hospitals.~   "
44827|NCT02980068|"~     This is an open-label, single-center study to examine distinguishing features of the~     structure and function of the oral and gut microbiome in healthy adult normal volunteers~     compared to volunteers with PH-HFpEF in the breakdown of oral nitrate.~   "
44828|NCT02980055|"~     The purpose of this study is to analyze the percentage of root coverage in Miller class I and~     II gingival recessions using connective tissue graft and collagen matrix with a two years~     follow-up.~   "
44829|NCT02980042|"~     This is a prospective between and within group observational study to determine differences~     in tolerability, immunogenicity and safety related outcomes for 100 multiple sclerosis (MS)~     patients who have been administered at least two infusions of rituximab, six months apart and~     are willing to be switched to ocrelizumab compared to a 100 patients who are continuing on~     rituximab as a comparison cohort from the clinic population treated as part of clinical care.~   "
44830|NCT02980029|"~     Primary Objective~      • To evaluate the pharmacodynamic effects on metabolic endpoints (malonyl carnitine and~     tripalmitin levels) following short-term treatment with TVB-2640 in patients with resectable~     cancers~      Secondary Objectives~        -  To determine if short-term treatment with TVB-2640 decreases cancer cell proliferation.~        -  To examine other biological endpoints and determine if TVB-2640 inhibits cell survival~          signaling and lipid biogenesis.~        -  To perform comprehensive metabolomic analysis in tumor tissues to identify metabolic~          alterations induced by TVB-2640 treatment.~        -  To correlate FASN levels in tumor with metabolic and biological endpoints to determine~          if FASN inhibition has more pronounced effects in patients with increased expression.~   "
44831|NCT02980016|"~     This study is a parallel, two part, open label, individually randomized, pragmatic trial~     among HIV-positive individuals. Part A compares a single round of weekly high dose~     rifapentine plus isoniazid for three months (3HP) to six months of daily isoniazid (6H). Part~     B compares periodic 3HP (p3HP) to a single round of 3HP.~   "
44851|NCT02979756|"~     A situational analysis on gestational diabetes conducted in 2015 in two districts in Morocco~     revealed difficulties in accessing screening for gestational diabetes (GDM) and delays in~     receiving appropriate care. Based on the results of the situational analysis, the~     investigators developed this proposal in close collaboration with the Moroccan research group~     on gestational diabetes composed of representatives of the Ministry of Health, researchers,~     members of professional organizations and specialists in the domains of endocrinology,~     gynecology, neonatal health and nutrition. The investigators opted for an hybrid~     implementation effectiveness trial to evaluate both clinical effectiveness of the proposed~     screening and initial management strategy and its implementation at the first level of care.~      The objectives of this study are thus to evaluate the feasibility of a decentralized strategy~     of screening for GDM and the initialization of GDM treatment already through the primary~     level of care and to assess its potential for scaling-up. Specific objectives of this study~     are to augment universal access to screening and management of gestational diabetes and to~     increase the competencies of health care providers at first level health care facilities to~     detect, start initial treatment and to improve follow-up of affected women. By comparing~     active screening and treatment initiation through first line health facilities with the~     existing practices, the investigators would like to explore the effect of the new model on~     maternal and newborn outcomes such as weight gain in pregnancy, occurrence of delivery~     complications and birth weight. The investigators will further assess the acceptability of~     screening and initial management of GDM through first line health services by health care~     providers and by pregnant women diagnosed with GDM and the impact of two different screening~     approaches on the lifestyle of affected mothers.~   "
44832|NCT02980003|"~     Intravascular administration of iodinated contrast media is an essential tool for~     cardiovascular imaging and percutaneous coronary interventions. Nonetheless, the increasing~     incidence of contrast-induced nephropathy (CIN) has become an important and prognostically~     relevant problem along with the spreading of diagnostic and interventional procedures. CIN is~     largely dependent on oxidative damage and represents a considerable cause of renal failure,~     being associated with prolonged hospitalization and significant morbidity/mortality. The most~     effective treatment strategy of this serious complication remains prevention, and several~     preventive measures have been extensively investigated in the last few years. Pre-procedural~     hydration is the best known and mostly accepted strategy. The administration of sodium~     bicarbonate (HCO3) has controversial effects, and is likely to be ineffective when the~     infused dose is unable to achieve adequate urine alkalinization. Since alkaline pH suppresses~     the production of free radicals, increasing urine pH would be an attractive goal for CIN~     prevention. In a randomized clinical trial the investigators will test the hypothesis that~     urine alkalinization with either oral or i.v. bicarbonate on top of hydration alone is the~     main determinant of CIN prevention in a population of patients with moderate or severe~     chronic kidney disease scheduled for coronary angiography and/or angioplasty. If the~     investigators, demonstrate non-significant differences in urine alkalinization (primary~     endpoint) and incidence of CIN (secondary endpoint) between the bicarbonate groups, a~     practical implication will be that oral administration is preferable for practical reasons~     over the administration of i.v. bicarbonate.~   "
44833|NCT02979990|"~     The Learning from Online Video Education (LOVE) study seeks to determine if online~     instructional videos on how to administer medication needed for in vitro fertilization (IVF)~     help improve the quality of life and reduce stress during the IVF process.~   "
44834|NCT02979977|"~     This is a single arm Phase II study for patients with recurrent or metastatic squamous cell~     carcinoma of the head and neck, who are previously treated with a platinum based regimen or~     with an immune checkpoint inhibitor. The primary objective is to evaluate the efficacy of the~     combination of cetuximab and afatinib.~   "
44835|NCT02979964|"~     Health Quality Ontario (HQO) is the provincial advisor on quality in health care. HQO~     currently conducts audit and feedback as a key quality improvement strategy. For example, it~     offers physicians working in long-term care homes with access to practice reports detailing~     rates of high-risk prescribing in comparison with others in Ontario and suggested change~     ideas. Research shows that providing this kind of feedback can lead to improvements in care.~     However, the size of these improvements depends how the feedback is presented. For instance,~     prior research suggests that how the results are 'framed' and what sort of benchmark the~     recipient is compared to may each affect how the physician will respond. This factorial trial~     tests each of these aspects of feedback design in the context of practice reports that~     nursing home physicians have already signed up to receive quarterly.~   "
44836|NCT02979951|"~     The purpose of this European, multicentric, prospective, non-interventional study is to~     document and evaluate the efficacy and safety of the treatment of severely infected patients~     with intravenously administered fosfomycin, including patients with osteomyelitis,~     complicated urinary tract infection, nosocomial lower respiratory tract infection, bacterial~     meningitis/central nervous system infection, bacteraemia/sepsis, skin and soft tissue~     infection, endocarditis or other infections, each as far as covered by the respective~     nationally relevant SmPC.~   "
44837|NCT02979938|"~     In this prospective observational study the investigators will report on 20 male subjects~     with proven WHO-classification Zika infection. These subjects will be followed up for a~     maximum of 12 months to observe the presence, viral load and infectivity of Zika virus (ZIKV)~     in semen over time.~   "
44838|NCT02979925|"~     The proposed study will set the foundation for future multi-center studies. To validate tMS~     as a non-contact and non-invasive pain treatment option for reducing pain in Veterans with~     PTP-NP and improving their overall functions.~   "
44839|NCT02979912|"~     Patients diagnosed with persistent corneal epithelial ulcers will be treated with autologous~     platelet lysate.~   "
44840|NCT02979899|"~     This is a study of TRC105 in combination with standard dose pazopanib compared to single~     agent pazopanib in patients with angiosarcoma not amenable to curative intent surgery (e.g.,~     metastatic or bulky disease, and disease for which surgical resection would carry an~     unacceptable risk to the patient) who have not received pazopanib or TRC105 previously.~   "
44841|NCT02979886|"~     Gonadotropin-releasing hormone analogue (GnRH-a) long protocol is a protocol for pituitary~     down-regulation in IVF. However, it is common in clinic that some patients are hypersensitive~     to pituitary down-regulation and have pituitary oversuppression, resulting in prolonged~     ovarian stimulation and increased consumption of exogenous gonadotropin(Gn). On the other~     hand, some patients may have insufficient pituitary down-regulation, which can affect the~     synchronization of ovarian follicles and consequently reduce the number of oocytes~     retrievable and lower the pregnancy rate. The differences in responses to GnRH-a among~     patients may be associated with the SNP of their GnRH receptor genes. It has been reported~     that mutations in GnRH receptor genes could change their binding affinity to the ligands,~     thus affecting the outcome of pituitary down-regulation. So far 20 non-synonymous mutations~     on the GnRH receptor genes have been reported, which can affect the function of GnRH receptor~     and are highly associated with disorders such as endometriosis and sexual precocity. However,~     the correlation between the SNP of GnRH receptor genes and the outcome of pituitary~     down-regulation in IVF has not been reported.~      The purpose of this study is to analyze the correlation between single nucleotide~     polymorphism (SNP) of GnRH receptor genes in infertile female patients and the extent of~     pituitary down-regulation by short-acting GnRH-a long protocol, with the goal to achieve~     individual down-regulation protocols based on the patients' SNP haplotypes of GnRH receptor~     genes and to improve the success rate of assisted reproductive technology.~   "
44852|NCT02979743|"~     The aim of this study is to explore the relationship between brain MRI-metrics and hand~     function observed in children with cerebral palsy (CP),compared between baseline and the~     third month, and thus determine the early MRI-based neuroimaging predictor of clinical~     improvement following therapy in children with CP.~   "
44879|NCT02979392|"~     The purpose of this study is to investigate the safety and to determine maximum tolerated~     dose and recommended phase 2 dose of TENPA (Targeting-Enhancing Nanoparticles of Paclitaxel)~     in patients with advanced solid tumor.~   "
44842|NCT02979873|"~     Background:~      People with severe aplastic anemia (SAA) do not make enough red and white blood cells, and/or~     platelets. Their body's immune system stops the bone marrow from making these cells. The~     treatment cyclosporine leads to better blood counts. But when this treatment is stopped, the~     disease may return in 1 in 3 people. The drug sirolimus may help by suppressing the immune~     system.~      Objective:~      To evaluate and compare the usefulness of sirolimus in preventing aplastic anemia from~     returning after cyclosporine is stopped, compared with stopping cyclosporine alone.~      Eligibility:~      People ages 2 and older with SAA who:~      Have responded to immunosuppressive therapy that includes cyclosporine, and continue to take~     cyclosporine~      Are not taking drugs with hematologic effects~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Blood and urine tests~      Bone marrow biopsy: The area above the hipbone will be numbed. A thin needle will remove~      some bone marrow.~      Participants will be randomly assigned to a group. All will stop cyclosporine. Group 1 will~     take sirolimus by mouth at the same time each day for 3 months with close monitoring. Group 2~     will not receive the study drug but will be monitored closely.~      Participants will have clinical tests for the first 3 months:~      Weekly blood test~      Monthly fasting blood test~      For group 1, measurements of sirolimus in the blood every 1 2 weeks~      Participants will have clinic visits at 3 months, 12 months, and annually for 5 years after~     the study starts. They may have another visit if their SAA returns. These will include:~      Blood and urine tests~      Bone marrow biopsy~   "
44843|NCT02979860|"~     Enhancing children's sleep duration and/or timing may represent a novel approach for weight~     regulation and prevention of T2DM. The proposed study will assess how experimental changes in~     children's sleep duration and timing affect weight regulation and T2DM risk. Sixty African~     American children ages 8-11 years old who sleep approximately 9.5 hours or less each night~     will be enrolled into a 4-arm randomized controlled pilot to compare three experimental~     manipulations in children's sleep to a typical sleep (TYP) control. Experimental arms will~     include: 1) increase in time in bed (TIB) by 90 minutes/night; 2) increase in TIB by 45~     minutes/night; or 3) consistent (CON) sleep schedule (but no change in TIB). At baseline, 2-~     and 4-week follow-up, participants be weighed and measured for height, have body fat assessed~     (bod pod), and their blood drawn (following an overnight fast). The pilot will provide~     important data on the potential role of sleep in combating disparities in cardiometabolic~     risk. Primary aims are: 1) to determine the effects of changes in sleep on changes in glucose~     regulation and 2) to determine the effect of changes in sleep on additional measures of~     glucose regulation and adiposity.~   "
44844|NCT02979847|"~     prospective randomized controlled trial~      In repeat procedure for persistent atrial fibrillation, Hybrid group (Epicardial ablation +~     Endocardial ablation) versus control group (conventional Endocardial ablation)~      Freedom from AF/Atrial tachycardia and safety~   "
44845|NCT02979834|"~     This study aims to investigate average gestational week in which mothers feel the~     babies'movements for the first time and maternal-fetal factors affecting this time.~   "
44846|NCT02979821|"~     In this trial, treatment efficacy and safety of Poziotinib will be assessed in patients with~     stage IV lung adenocarcinoma harboring HER2 mutation.~   "
44847|NCT02979808|"~     This study is designed as an open, prospective, non-controlled, qualitative, multicentre~     study of a novel transanal irrigation system performed in a population of 150 subjects~     suffering from spinal cord injury and confirmed neurological bowel dysfunction. The study is~     expected to last for a total of 1 year (treatment period) with a planned 12- month~     recruitment period and three scheduled site visits.~   "
44848|NCT02979795|"~     Rectal cancer, comprised of 30% of overall colorectal cancer cohort, is one of the leading~     cancers of Taiwan. In patients with advanced disease, the standard of care is concurrent~     chemoradiotherapy (CCRT) before surgery. After CCRT, the abscopal effect, a phenomenon that~     localized radiation not only destroys local tumor but also inhibits the growth of tumor at~     the remote site, has been observed. This effect is believed to be associated with tumor~     immune response. In addition, other immune checkpoint molecules, such as Programmed cell~     death-1(PD-1), Programmed cell death ligand-1 (PD-L1), and Cytotoxic T-Lymphocyte Associated~     Protein 4 (CTLA-4), have been reported associated with therapeutic outcome. However, after~     CCRT, more than 50% of patients were still either having persistent disease or developed~     distant metastasis. To improve therapeutic outcome of patients with rectal cancer, this~     project, thus, aims at exploring the evolution of factors that may affect the abscopal effect~     and immune checkpoint functions in tissues and in blood before and after CCRT.~   "
44849|NCT02979782|"~     Primary objectives:~      Assessment of the incidence of postoperative cognitive dysfunction (POCD), cerebrovascular~     accident (CVA), and delirium after minimal invasive coronary artery bypass grafting~     (Endo-CABG).~      Secondary objectives:~        -  Quality of life, three months after endo-CABG~        -  Patient satisfaction with endo-CABG and the tests performed~        -  The influence of various demographic and peri-operative variables on neurological~          outcome after endo-CABG~        -  Incidence of fear and depression, 3 months after endo-CABG~   "
44850|NCT02979769|"~     Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease~     characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) that result~     in abnormal bone formation (heterotopic ossification or HO) in muscles, tendons, and~     ligaments. Flare-ups begin early in life and may occur spontaneously or after soft tissue~     trauma, vaccinations, or influenza infections. Recurrent flare-ups progressively restrict~     movement by locking joints leading to cumulative loss of function and disability. Mouse~     models of FOP have demonstrated the ability of retinoic acid receptor gamma (RARγ) agonists~     such as palovarotene (PVO) to prevent HO following injury. This 24-month study will (1)~     continue to follow FOP subjects from France who completed Clementia Study PVO-1A-201; (2)~     enroll up to eight additional new French subjects who have achieved at least 90% skeletal~     maturity; and (3) evaluate the ability of different palovarotene dosing regimens to prevent~     HO in these subjects.~   "
44880|NCT02979379|"~     This study is aimed at determining the role of pain in individuals with chronic obstructive~     pulmonary disease (COPD) who are enrolled in a pulmonary rehabilitation (PR) program. It is~     not known whether pain interferes with an individuals performance in PR, or whether PR~     aggravates or relieves pain. Individuals with COPD who report chronic pain and those without~     pain will be enrolled in the study.~   "
44853|NCT02979730|"~     The purpose of the study is to compare Emergency Department patients who undergo influenza~     testing using an FDA-approved point-of-care device (Cobas Liat Influenza A/B assay) located~     in the ED, to patients whose samples are sent to the BMC central laboratory. Patients who~     agree to participate will have their samples randomly assigned to be tested on either at the~     core lab, or on the POC device. The current turnaround time for samples sent to the~     laboratory is approximately two hours; investigators expect that the point of care device can~     reduce this time. Investigators will determine if the time to disposition and the~     administration of antibiotics is different in the group undergoing POC influenza testing~     compared to those undergoing laboratory-based influenza testing~   "
44854|NCT02979717|"~     The objective of this study is to determine the effect of a high protein, high fiber~     supplement pre-load on energy intake at a subsequent meal compared to a low fiber, high~     carbohydrate Control product in healthy overweight and obese subjects. The investigators~     hypothesize the high protein, high fiber pre-load will result in reduced energy intake at a~     subsequent meal compared to low protein, low fiber.~   "
44855|NCT02979704|"~     This study will be conducted to assess the status of oxidative stress inflammation and~     thrombogenesis in patients with hyperlipidemia and to compare the antioxidative,~     anti-inflammatory and antithrombogenic effects of rosuvastatin and atorvastatin.~   "
44856|NCT02979691|"~     Ratiotherapy alone is the current standard treatment for elderly esophageal or~     esophagogastric cancer in China. And Little is known about chemoradiotherapy (CRT) in elderly~     patients. This study aimed to assess the efficiency and safety of simultaneous integrated~     boost (SIB) intensity modulated radiation therapy (IMRT) with S1 based SIB-IMRT followed by~     adjuvant chemotherapy with S1 in in elderly (age ≥70 years) esophageal or esophagogastric~     cancer patients~   "
44857|NCT02979678|"~     The purpose of this study is to update the EORTC QLQ Breast (BR)-23 Module. Since the~     development of BR-23 published 1996 the standard therapy of breast cancer has changed. New~     therapies brought new side effects and different impact on QoL (quality of life) are not~     sufficiently covered by EORTC QLQ BR-23 and an update of the module could be useful, both~     from clinical and scientific point of view.~   "
44858|NCT02979665|"~     anti-VEGF therapy is an established method to control leakage and abnormal growth of retinal~     blood vessels. Questions on the long-term effect on the retina, intraocular pressure and on~     the overall retinal perfusion from these treatments remain to be answered. The purpose of the~     study was to evaluate changes in the retina following anti-VEGF treatment over time, using~     structural and functional diagnostic tests.~   "
44859|NCT02979652|"~     This study is done to estimate prevalence of the main detectable lung and cardiovascular~     complications by an ultrasound realized in room of post-interventional supervision at the~     patients whose duration of general anesthesia is superior at one hour after a surgery to risk~   "
44860|NCT02979639|"~     The purpose of this study is to evaluate the impact of reactogenicity of GSK Biologicals'~     HZ/su vaccine on Quality of Life (QoL) in adults ≥ 50 years of age~   "
44861|NCT02979626|"~     The purpose of this study is to determine whether a moderate-severe endpoints (including high~     fever, lower respiratory tract disease, acute otitis media, or serious extra-pulmonary~     complications are predictive of hospitalization, intensive care admission, antibiotic use and~     other complications in children under 8 years of age.~   "
44862|NCT02979613|"~     The primary objectives of this study are to evaluate the efficacy, safety, and tolerability~     of switching to tenofovir alafenamide (TAF) versus continuing tenofovir disoproxil fumarate~     (TDF) in virologically suppressed adults with chronic hepatitis B virus (HBV) infection.~   "
44863|NCT02979600|"~     An oral tolerance induction (OTI) protocol is conducted at the allergy Unit of Saint Vincent~     Hospital of Lille (France) in standard care since 2006. This protocol consists in exposing~     patients to regularly increasing doses of allergen. This protocol induces an increase of the~     threshold reactive dose (the minimum dose of allergen that triggered a reactive reaction) and~     a decrease of the quantity of specific immunoglobulin E (sIgE) against peanut proteins. The~     protocol is ended when the patient reaches a threshold reactive dose of 2942mg of peanut~     proteins, corresponding to 14 peanuts of middle size, which is the maximum dose of peanut~     that can be found in standard product in France.~      The investigators wish to study the evolution of the threshold reactive dose and of the sIgE~     of patients that have followed the OTI protocol. All the needed data are available in the~     medical records so the study will be conducted on retrospective data.~   "
44864|NCT02979587|"~     The purpose of this study is to further evaluate the safety and effectiveness of the Harmony™~     TPV system.~   "
44865|NCT02979574|"~     The purpose of this study is to compare two types of acupuncture with usual care on treating~     chronic pain. This study has three groups. Two groups will received acupuncture. One group~     will receive usual standard of care for 12 weeks and then will receive acupuncture.~     Acupuncture is an ancient Chinese technique of using very thin needles inserted in the skin~     to treat different symptoms and illness, and to promote healing. Each group will undergo a~     different method of needle administration.~   "
44866|NCT02979561|"~     A prospective randomised controlled study to evaluate outcomes of the treatment with pradaxa~     or warfarin for prevention of recurrent DVT in patients with angiographically confirmed acute~     massive pulmonary embolism undergoIng endovascular mechanical fragmentation and thrombolytic~     therapy. [RE-SPIRE study]~   "
44875|NCT02979444|"~     There is considerable evidence that most perinatal women at risk for postpartum depression do~     not engage in mental health services, even when referred by home visiting (HV) programs,~     primary care physicians, obstetricians, or gynecologists. Thus, interventions that can be~     delivered via alternative settings—e.g., HV programs—are essential to prevent the onset of~     major depression and worsening of depressive symptoms among perinatal women. This Patient~     Centered Outcomes Research Institute (PCORI) funded project aims to evaluate whether the~     Mothers and Babies (MB) group intervention, when led by paraprofessional home visitors, is~     more efficacious than usual care (i.e., home visiting without the MB enhancement). It will~     also examine if MB, when led by paraprofessional home visitors, is not inferior to MB~     delivered by mental health professionals. The results of this study will inform~     decision-making by HV programs regarding provision of MB to perinatal women at risk for~     developing major depression.~   "
44867|NCT02979548|"~     The purpose of the study is to find out the efficacy of an anti-emetic drug, Aprepitant as an~     add-on therapy to prevent vomiting in children and adolescents receiving chemotherapy for~     leukemia (AML).~      Children and adolescents admitted with confirmed diagnosis of AML will be assessed for~     eligibility criteria and enrolled in the study. Then they will be divided (randomized) into~     experimental and control groups.~      Experimental group will receive Aprepitant capsules 1 h prior to chemotherapy on days 1-3 in~     addition to ondansetron. Patients will be required to swallow the whole capsule and opening~     of capsule will not be permitted. All three doses will be administered under supervision.~      Control group will receive ondansetron (0.15 mg/kg) as an intravenous bolus 30 minutes before~     chemotherapy followed by every 8 hourly for 8 days. Metoclopramide will be used as a rescue~     agent.~      The data will be collected from each patient in a proforma from day 1 to day 13 of~     chemotherapy. A Diary will be maintained for nausea and vomiting record.~      Edmonton's symptom assessment criterion will be used in the diary for assessing severity of~     nausea. The NCI guidelines will be used to assess the severity of vomiting based on the data~     provided by the patient in the diary.~      A modified intention-to-treat population (patients who receive chemotherapy, take one or more~     doses of study drug, and have one or more post treatment measurements) will be used for~     efficacy analysis. Proportion of patients with complete response will be compared between~     patients with or without aprepitant.~   "
44868|NCT02979535|"~     The aim of this study is to investigate the immunogenicity and safety of CYD dengue vaccine~     and Cervarix when administered concomitantly or sequentially in healthy female subjects aged~     9-14 years of age.~      Primary objectives:~        -  To demonstrate that the humoral immune response (in terms of geometric mean titers~          [GMTs]) to Cervarix after concomitant administration with the CYD dengue vaccine is~          non-inferior to the humoral immune response (in terms of GMTs) after sequential~          administration with the CYD dengue vaccine measured 28 days after the last dose of~          Cervarix~        -  To demonstrate that the humoral immune response (in terms of GMTs) to the CYD dengue~          vaccine after concomitant administration with Cervarix is non-inferior to the humoral~          immune response (in terms of GMTs) to the CYD dengue vaccine after sequential~          administration with Cervarix measured 28 days after the last dose of the CYD dengue~          vaccine~      Secondary Objectives:~        -  To demonstrate that the humoral immune response (in terms of seroconversion) to Cervarix~          after concomitant administration with the CYD dengue vaccine is non-inferior to the~          humoral immune response (in terms of seroconversion) to Cervarix sequential~          administration with the CYD dengue vaccine measured 28 days after the last dose of~          Cervarix~        -  To describe the humoral immune response to Cervarix at baseline and after each dose of~          Cervarix in each and any group~        -  To describe the humoral immune response to the CYD dengue vaccine at baseline and after~          each dose of the CYD dengue vaccine, in each and any group~        -  To describe the safety of Cervarix and CYD dengue vaccine after each and any dose in~          each group~   "
44869|NCT02979522|"~     The purpose of this study is to assess the safety, tolerability, and anti-tumor activity, as~     well as recommended dose of brentuximab vedotin (ADCETRIS) in combination with a multiagent~     chemotherapy regimen, doxorubicin (Adriamycin), vinblastine, and dacarbazine, in pediatric~     participants with advanced stage newly diagnosed classical CD30+ Hodgkin Lymphoma (HL).~   "
44870|NCT02979509|"~     All patients will receive standard medical care and no experimental interventions will be~     performed. Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is a~     well-established procedure commonly used for the investigation of lesions within or adjacent~     to the gastrointestinal (GI) lumen (i.e. pancreas, liver, mediastinal masses, left adrenal~     gland, lymph nodes, and subepithelial lesions). EUS-guided tissue sampling has been commonly~     performed with different size and types of aspiration and core biopsy needles.~   "
44871|NCT02979496|"~     The purpose of this study is to evaluate the effect of daily intake of orange pomace on~     gastrointestinal function as measured by stool frequency. Additional outcomes will include~     aspects of digestive health, diet quality, and fasting blood glucose and lipid~     concentrations. Possible explanations for the mechanism of the pomace will be explored in~     microbial ecology analyses.~   "
44872|NCT02979483|"~     This study assessed the feasibility and effects of an early integrative supportive care~     program in patient with Advanced pancreatic adenocarcinoma (aPDAC).~   "
44873|NCT02979470|"~     The main reason of cancer-related mortality is the spread of cancer cells to distant sites~     (micrometastases). However, only a few small groups of tumor cells can metastasize by~     acquiring mechanism to decrease the immune response. Changes in the systemic inflammatory~     response to the tumor can be measured by blood-based parameters. In particular, the~     proportion of neutrophyls- lymphocytes (NL) has been evaluated for predicting the survival of~     patients with different types of cancer. The first strategy to treat colorectal cancer (CCR)~     is complete resection of the lesion. Nevertheless, some patients experience recurrence,~     probably due to residual micrometastases. We have demonstrated that analysis of some~     resistance proteins (Tyms / MRP1) in circulating tumor cells (CTCs) may predict treatment~     response in metastatic CCR patients (mCRC). We also note that the CTCs kinetics can show~     response to therapy. Patients with stage III disease in the colon / rectum, although showing~     high cure rate, generally fall locally or remotely and studies with blood markers in this~     group of patients is still scarce. Primary Objective: To investigate cells found in the blood~     (lymphocytes and neutrophils and CTCs) to verify if they can help in the choice of~     anti-neoplastic therapy in patients with advanced colon and rectum cancers. Secondary~     objectives: - to evaluate the influence of CTC kinetics in response to treatment of patients~     with advanced colon/rectum cancers; - to check the expression of treatment resistance,~     invasion and proliferation proteins (Tyms, TGF-βR, MMP-2, β-gal, Ki-67 and CD45) in CTCs and~     their correlation with response to treatment; - to check the mRNA expression of the same~     genes observed by immunocytochemistry in CTCs and their correlation with response to~     treatment; - to quantify CTCs, neutrophils and lymphocytes of patients included in this study~     and verify if there are correlation among their rates and progression-free survival. Methods:~     there will be collected 10 ml of blood of patients with advanced colon and rectal cancer for~     analysis of CTCs, lymphocytes / neutrophils. CTCs will be isolated, quantified and analyzed~     after separation by ISET method (Rarecells/France). The marker analysis of these cells will~     be done by immunocytochemistry and the gene expression will be assessed by RNAscope. The~     quantification of lymphocytes/neutrophils will be made by common blood count in Delboni~     laboratory. Expected Results: We propose to show that not only the count and the kinetics of~     CTCs, but also their molecular characteristics, can provide relevant information to~     clinicians. Hopefully, by quantification of neutrophils and lymphocytes, we will be able to~     identify new prognostic blood biomarkers that can direct clinicians to the best therapeutic~     choice.~   "
44874|NCT02979457|"~     The overall aim of the study is to construct a scale that systematically incorporates the~     callers' perspective in a degree of worry - scale and to explore the consequences for the~     actors in the system - caller, call-handler, and health care system.~      This will be done through four independent studies.~        1. Is it possible to validate the degree of worry scale with the software system Corti?~        2. Does callers' degree of worry relieve after telephone consultation?~        3. Does call handlers' awareness of degree of worry affect triage outcome?~        4. Is callers' degree of worry a predictor of illness severity?~   "
44882|NCT02979353|"~     This randomized, controlled trial will evaluate the effects of an intervention to reduce~     exposure to medications among hospitalized older adults discharged to skilled nursing~     facilities (SNFs). The goal of the intervention is to safely deprescribe medications, as~     defined by dose reductions and stopped medications, based on a combination of clinical~     criteria and patient preferences. The investigators will evaluate the effects of the~     intervention on the total number of medications prescribed to patients at hospital and SNF~     discharge and at home 90-days after SNF discharge along with the prevalence of eight~     geriatric syndromes, medication adherence, and health status.~   "
44883|NCT02979340|"~     Specific Aim 1. Determine if valid results of non-sedated MRI based assessments of liver~     stiffness and lipid content can be obtained in more than 90% of children and young adults~     with cystic fibrosis.~      Specific Aim 2. Determine hepatic lipid content using the HepaFat sequence and liver~     stiffness using MRE. Investigators will compare the results obtained by MRI with PUSH study~     grayscale ultrasounds in CF patients with normal, heterogeneous, homogeneous or nodular~     (cirrhotic) pattern on ultrasound.~      Specific Aim 3. Creation of an imaging core lab to centralize evaluation of MR imaging data,~     allow for remote image upload, electronic data storage, and remote image~     viewing/interpretation. This infrastructure will be utilized to standardize image post~     processing.~      Specific Aim 4. Using the longitudinal PUSH study, determine if MRI based imaging improves~     discrimination of subjects at risk for progression to advanced CF liver disease (development~     of cirrhosis) compared to using US imaging alone~   "
44884|NCT02979327|"~     This study is designed to investigate the cardiovascular response (blood pressure, heart~     rate, electrocardiographic response and blood vessel reactivity response) to taking Adderall~     in healthy adults.~   "
44885|NCT02979314|"~     Corroboratory behavioral evidence showed interaction effects between vestibular stimulation~     and egocentric transformation.~      The investigators here examine in healthy participants, whether there are shared brain~     mechanisms underlying galvanic vestibular stimulation, illusory self-motion and egocentric~     transformation, as well as their interaction.~      It is hypothesized that the GVS induced illusory self-motion dampens the ability to perform~     egocentric mental transformation.~   "
44886|NCT02979301|"~     The study will examine whether changes in background parenchymal uptake (BPU) on molecular~     breast imaging (MBI) can be induced by short-term use of low-dose tamoxifen. Women who have~     previously had high BPU on MBI will be recruited. Participants will take low-dose tamoxifen~     for a 30-day period, with post-tamoxifen MBI in order to investigate the impact of tamoxifen~     on BPU.~   "
44887|NCT02979288|"~     In the currently presented trial, investigators aim to evaluate the treatment of the~     intermediate vaginal microbiota during the first trimester of pregnancy with vaginal~     lactobacilli to restore the normal vaginal microbiota and therewith reduce the rate of PTD.~     All pregnant women between 10 + 0 (10 weeks plus 0 days) and 16 + 0 (16 weeks plus 0 days)~     gestational weeks in study group will be treated with vaginal Lactobacilli Capsules~     containing L. Casei rhamnosus LCR 35~   "
44888|NCT02979275|"~     Identification of risk factors of acute kidney injury (AKI). It is hypothesized that there~     might be a correlation between brain oximetry, tissue saturation of thenar muscle and marker~     of AKI in blood - neutrophil gelatinase-associated lipocalin (NGAL) - measured in blood~     samples during the first post-op day.~   "
44889|NCT02979262|"~     The proposed stage 1 intervention development study is designed to address two significant~     co-occurring issues for fathers with substance abuse (SA) problems: Intimate partner violence~     (IPV) and child maltreatment (CM). SA treatment programs are an important avenue to reduce~     family violence because SA treatment alone does not result in an end to these behaviors.~     Currently available interventions have had little success in reducing male IPV. Fathers for~     Change, an integrated outpatient intervention, shows promise as an intervention model~     targeting the intersection of SA, IPV, and CM. The intervention uses men's roles as fathers~     as a motivation for change and targets factors that are known to trigger SA, IPV and CM:~     hostile cognitions and poor emotion regulation. An intervention of this sort has not been~     integrated and tested as part of a residential substance abuse program for men. This project~     is a pilot study of 60 fathers randomly assigned to Fathers for Change or a Parent Education~     Program (PE) comparison. The initial feasibility of the Fathers for Change will be assessed~     by comparing it to PE in the areas of: participant completion rates, hostile cognitions,~     emotion regulation, SA relapse, IPV, and CM risk behaviors (negative parenting). Change in~     hostile cognitions and emotion regulation will be examined as the mechanisms through which~     Fathers for Change reduces relapse, IPV and CM risk behaviors.~   "
44890|NCT02979249|"~     In the medical literature there are conflicting reports on whether iron improves symptoms in~     patients with EPP and XLP. Giving iron to people who are iron deficient is thought to improve~     EPP symptoms. However, this has never been systematically tested. Therefore, the purpose of~     this study is to determine the effect of oral iron for EPP and XLP patients.~   "
44891|NCT02979236|"~     The aim of this registry is to collect clinical data on nitinol self-expanding STENTYS~     Xposition S™ in order to evaluate the efficacy and safety in patients presenting with ST~     segment elevation myocardial infarction~   "
44892|NCT02979223|"~     The aim of this study is to compare the efficacy depending on the order of the sequential~     combination method using sodium picosulfate and magnesium citrate (PMC) and PEG with ascorbic~     acid for bowel preparation.~      The investigators designed this study as a phase II prospective randomized parallel arm~     clinical trial. 67 participant will be enrolled in each group (134 in total).~      The primary outcome is the efficacy of bowel preparation. secondary outcomes are~     tolerability, side effect of the drugs, polyp detection rate and adenoma detection rate.~   "
44893|NCT02979210|"~     The rationale for the study is to better understand the dynamics of skin microflora following~     skin barrier disruption in an adult dermatitis model. The results from this study will~     provide insights in the complex interaction between skin microbiome and epidermis under~     normal and disease conditions~   "
44939|NCT02978612|"~     This is a phase 2, randomized study where the aim of the study is to investigate the~     tolerance of adjuvant chemotherapy, measured by functional decline, after surgery for colon~     cancer stage III in elderly patients. Secondary aims are disease-free survival, toxicity,~     late functional outcome, quality of life, to establish a geriatric assessment for selection~     of patients, and to examine the prognostic value of gene signature tests / biomarkers for~     stage III colon cancer.~   "
44894|NCT02979197|"~     The purpose of this study is to evaluate the effect of celecoxib on the efficacy and safety~     of amlodipine on renal and vascular function in subjects with existing hypertension requiring~     antihypertensive therapy.~      Kitov Pharmaceuticals, Ltd. (Kitov) is developing KIT-302, an oral fixed combination drug~     product (FCDP) consisting of the antihypertensive drug amlodipine besylate and the~     non-steroidal anti-inflammatory drug (NSAID) celecoxib.~      KIT-302 is being developed as a convenience reformulation FCDP to facilitate and improve~     patient compliance with the once a day (qd) administration of its individual components,~     amlodipine and celecoxib, when used together for the treatment of hypertension, to lower~     blood pressure, in patients who also require the use of an NSAID for relief of the signs and~     symptoms of osteoarthritis. It is also intended to provide prescribers with detailed data on~     how the combination affects the antihypertensive effect of the calcium channel blocker.~      The formulation of KIT-302 consists of amlodipine besylate and celecoxib co-formulated in a~     single immediate release tablet. However, for this study, two separate capsules will be~     utilized: one containing a commercial celecoxib capsule (Celebrex®) or matched placebo~     capsule and one containing a commercial amlodipine besylate tablet (Norvasc®) or matched~     placebo tablet.~      Kitov recently completed a phase 3 pivotal trial in subjects with newly diagnosed~     hypertension (KIT-302-03-01) demonstrating that the amlodipine + celecoxib combination was~     statistically non-inferior to amlodipine monotherapy with regard to reduction of blood~     pressure. Further, trends towards superior blood pressure lowering effects and improved renal~     function were observed for the combination. This study (KIT-302-03-02) is being conducted to~     quantify the beneficial renovascular effects noted in the prior study in subjects with~     existing hypertension requiring antihypertensive therapy.~   "
44895|NCT02979184|"~     Rehabilitation results in a decrease of the perimeters of the limb with lymphedema by a~     decrease in the amount of liquid of the affected limb, with movement of the intracellular~     liquid towards the trunk and the neck then into the jugular-subclavian confluence, the~     superior vena cava and right atrium without modification of extracellular fluid. No study~     have evaluated the prevalence of sleep apnea syndrome in this population and the effect of~     this treatment on sleep apnea syndrome.~   "
44896|NCT02979171|"~     Supraglottic airway tools, one of the tools used in the management of the difficult airway.~     American Society of Anesthesiologists and the Difficult Airway Society of the United Kingdom~     airway management algorithms have included the LMA. In our study investigators aimed to~     determine which one will show the best performance with supraglottic airway means that LMA -~     Classic, LMA - Flexible and LMA - ProSeal in patients that difficult airway scenarios created~     with attaching collar.~   "
44897|NCT02979158|"~     Patients admitted for coronary artery bypass surgery taking antiplatelet medicine have an~     increased risk for bleeding.~      Present study aims to compare the platelet function in two patient groups using different~     types of heart-lung machine methods.~      It is assumed that one of the methods is superior verified by sensitive methods of testing~     platelet function.~   "
44898|NCT02979145|"~     The purpose of this study is to develop and validate a clinical outcome measure to evaluate~     disability and disease progression of children 3 years of age and younger (infants and~     toddlers) with various types of Charcot-Marie-Tooth disease (CMT).~   "
44899|NCT02979132|"~     Conventional indirect indicators of iron status, using serum and red blood cell biomarkers,~     are confounded by inflammation from common infections and are therefore of limited use in~     populations carrying a high burden of infection and inflammation, as for example women of~     reproductive age in malaria endemic areas in developing countries. Even without the~     confounding effect of inflammation, current markers of iron status are insensitive to small~     changes in dietary iron and do not allow to establish associations between dietary, lifestyle~     and genetic factors and iron balance. With a new method based on the dilution of a previously~     administered and equilibrated stable isotope signal, an accurate measurement of long-term~     oral iron balance and absorption is possible, allowing the estimation of iron requirements~     and potentially providing fundamental guidance for supplementation and fortification programs~     in both healthy and chronically inflamed/infected patients. In the current study the novel~     methodology will be validated in generally healthy subjects with low iron status. The~     technique will be used to assess dietary and lifestyle determinants of iron status and to~     compare the effect on iron balance and iron status of three distinct, commonly used iron~     interventions: food fortification with iron; oral iron supplementation, and intravenous iron~     infusion.~   "
44900|NCT02979119|"~     Rationale:~      Haemophilia is a rare disease; to improve knowledge international collaboration is needed.~     Well-defined clinical data will be collected from complete cohorts in order to prevent~     selection bias.~      Objective:~      To collect data on bleeding during neonatal period, endogenous (genetic) and exogenous~     (treatment-related) determinants of inhibitor development and long term outcome.~   "
44901|NCT02979106|"~     Background: High fructose intake increases blood lactate, triglyceride and uric acid~     concentrations. Uric acid may contribute to insulin resistance and dyslipidemia in the~     general population. In patients with hereditary fructose intolerance fructose consumption is~     associated with acute hypoglycemia, renal tubular acidosis, and hyperuricemia.~      Objective: We investigated whether asymptomatic carriers for hereditary fructose intolerance~     (HFI) would have a higher sensitivity to adverse effects of fructose than the general~     population.~      Design: Eight subjects heterozygous for HFI (hHFI; 4 males, 4 females) and eight controls~     received for 7 days a low fructose diet and on the eighth day ingested a test meal calculated~     to provide 25% of basal energy requirement containing labeled fructose (13C fructose 0.35~     g/kg), protein (0.21 g/kg) and lipid (0.22 g/kg). Total fructose oxidation, total endogenous~     glucose production (by 6,6-2H2-glucose dilution), carbohydrate and lipid oxidation, lipids,~     uric acid, lactate, creatinine, urea and amino acids were monitored for 6 hours.~   "
44902|NCT02979093|"~     A prior study by the principal investigator of this project identified dopamine- and~     oxytocin-related brain pathways that showed a diminished response when addicted mothers~     viewed the faces of their own vs. unknown infants, compared with non-addicted mothers. These~     areas include the hypothalamus, striatum and ventromedial prefrontal cortex. Oxytocin, a~     neuropeptide with decreased blood levels seen in addicted mothers, is integrally involved in~     maternal brain and behavioral responses. When administered intranasally, the pilot data has~     shown enhanced activation of the striatum, prefrontal cortex (PFC) and amygdala.~      The purpose of this study is to continue and expand upon the previous investigation of~     maternal addiction, by conducting a randomized, double-blinded, placebo controlled, crossover~     study of intranasal oxytocin on maternal brain responses. 150 mothers from the University of~     Iowa and the Yale Child Study Center will be enrolled (75 with a history of drug addiction~     and 75 matched control mothers), along with their 2 to 12-month-old infants, to participate~     in four study visits over a two-month period.~   "
44940|NCT02978599|"~     Single-center, outpatient, randomized, double-blind, placebo-controlled, 3-treatment-phase,~     cross-over study to evaluate the safety, tolerability and efficacy of two oral doses of~     AVL-3288 each compared to placebo, in patients with schizophrenia.~   "
44903|NCT02979080|"~     Conventional indirect indicators of iron status, using serum and red blood cell biomarkers,~     are confounded by inflammation from common infections in sub-Saharan Africa, a region with a~     high prevalence of iron deficiency, making the assessment of iron balance and efficiency of~     iron intervention difficult. A potential reference method to quantify iron absorption and~     requirements using isotope dilution measurements in women living in areas with high burden of~     infection should be developed and validated within this project. The new method will allow~     accurate measurement of long term oral iron absorption and the estimation of iron~     requirements, potentially providing fundamental guidance for supplementation and~     fortification programs in sub-Saharan Africa. In a case series with four months' preventative~     iron supplementation intervention imbedded between a four months' control period prior~     intervention and a four months' control period after intervention, we will follow a group of~     63 women. During the intervention period, the women will receive 50 mg Fe as ferrous sulfate~     tablets every day for 120 d. In total, the women will give 9 blood samples (day 1, 60 120,~     150, 180, 210, 240, 300 and 360) for the de-termination of the isotopic composition and iron~     status biomarkers and 5 stool samples (day 1, 120, 180, 240 and 360) for the detection of~     soil transmitted helminths and gut inflammation. This design will allow the measurement of~     the isotopic iron dilution to assess the total oral iron absorption during the intervention~     period in comparison with the control periods without the administration of additional iron~     isotopes.~   "
44904|NCT02979067|"~     Improvement of oxygenation during apnoea by i-THRIVE Infant Transnasal Humidified Rapid~     Insufflation Ventilatory Exchange A single-centre prospective randomized controlled trial.~   "
44905|NCT02979054|"~     The purpose of this study is to assess the performance and safety of T4020 versus saline~     solution.~   "
44906|NCT02979041|"~     The aim of the proposed study is to investigate the effectiveness of an interactive, virtual~     reality (VR) training program for pilots compared with standard care. The study will be a~     randomized controlled trial (RCT) consisting of 60 pilots randomized into one of two groups:~     standard physiotherapy and medical care vs standard care and VR training. Outcome measures~     will include subjective scores of pain intensity and global perceived effect; objective~     measures of range of motion (ROM), neck motion velocity, and motion accuracy; and functional~     measure of days grounded due to neck pain. Data will be analyzed using ANOVA for within and~     between groups analyses.~   "
44907|NCT02979028|"~     This is a single center, randomized, double-blinded, controlled clinical trial. The purpose~     of this study is to to determine whether treating by transcutaneous electrical acupoint~     stimulation (TEAS) during perioperative could alleviate the postoperative complications in~     patients undergoing artificial joint replacement surgery.~   "
44908|NCT02979015|"~     Primary Objective:~      To assess the safety and tolerability of ascending single SC doses of alirocumab in Chinese~     healthy subjects.~      Secondary Objectives:~        -  To assess the pharmacokinetic profile of a single SC dose of alirocumab.~        -  To assess the pharmacodynamic effect of a single SC dose of alirocumab on low-density~          lipoprotein cholesterol (LDL-C) and other lipid parameters.~        -  To assess the immunogenicity of a single SC dose of alirocumab.~   "
44909|NCT02979002|"~     The aim of this study is to estimate the accuracy of CL Detect Rapid Test™ compared to a~     composite reference standard test (Direct examination of skin smears + PCR test) in patients~     with clinically suspected Cutaneous Leishmaniasis disease in Morocco.~   "
44910|NCT02978989|"~     To determine the safety and feasibility of solo laparoscopic cholecystectomy, which is~     defined as the application of solo surgery to laparoscopic cholecystectomy, by comparing~     consecutive non-solo procedures conducted by a surgeon in the presence or absence of human~     assistant(s).~   "
44911|NCT02978976|"~     The aim of this study is to determine the effect of administering antenatal steroids in term~     fetuses on the blood flow in the fetal pulmonary artery, and to correlate these findings with~     clinical data obtained after birth documenting respiratory disorders.~   "
44912|NCT02978963|"~     This case series aims to test the feasibility and acceptability of streamlined cognitive~     behavioral therapy (CBT) for adolescents with excessive worry. The treatment protocol focuses~     on reducing intolerance of uncertainty and the hypothesis is that this will help reduce~     worry.~   "
44913|NCT02978950|"~     This is a prospective, randomized vanguard trial of trauma patients admitted to the trauma~     surgery service at Intermountain Medical Center who are deemed to be at high risk for venous~     thromboembolism. Once identified and enrolled, subjects will be randomized to receive~     bilateral lower extremity duplex ultrasound surveillance versus no surveillance. The study~     will compare the two groups with regard to deep vein thrombosis, pulmonary embolism, and~     major and clinically relevant bleeding episode rates, both during the index hospitalization~     and at 90 days post-discharge.~   "
44914|NCT02978937|"~     This is an observational study involving chart review of patients seen in the bariatric~     clinic since 2012 at The Ohio State University (OSU). Obese patients will be divided into two~     groups according to their metabolic profile (healthy vs unhealthy). The assignment to each~     group will be determined by the presence of diagnosis of hypertension, diabetes mellitus~     and/or dyslipidemia. The presence of at least 2 diagnoses will be defined as metabolically~     unhealthy. Then, each group will be divided based on the presence of Obstructive Sleep Apnea~     diagnosis. All data will be collected through a review of the patient's electronic medical~     record from the bariatric clinic database (the investigators will collect variables as age,~     gender, race, BMI, smoking status, the presence of diagnosis as Obstructive sleep apnea,~     hypertension, diabetes, hyperlipidemia). The investigators will analyze that data and~     establish if there is any correlation between sleep apnea and the subjects' metabolic~     profile.~   "
44915|NCT02978924|"~     To explore the effect of cathodal tsDCS vs sham tsDCS in primary orthostatic tremor. The~     investigators hypothesize that cathodal tsDCS but not sham tsDCS would be able to restore~     both motor and sensory pathways of the spinal cord leading to functional improvements.~   "
44941|NCT02978586|"~     The purpose of this study is to see if positron emission tomography/ magnetic resonance~     imaging (PET/MRI) can be used to monitor the effectiveness of cancer treatment using an~     investigational radioactive drug called [Ga-68]PSMA.~   "
44942|NCT02978573|"~     Evaluate and confirm the long-term safety and effectiveness of the Cartiva SCI implant~     established by the pivotal trial.~   "
44916|NCT02978911|"~     Introduction: The skull base tumors surgery remains a challenge since numerous cranial nerves~     or vessels closely surround them. Recently, diffusion tensor imaging has developed with the~     tractography following white fibers and visualizing functional tracts. Cranial nerves~     tractography could allow predicting their displacement by skull base tumors that may help the~     surgeon to spare them along the surgery.~      Methods: Preoperative cerebral MRI was performed on patients who presented with skull base~     tumors. A 3 tesla MRI machine was used to acquire DTI sequence with specific parameters: 32~     directions, slice thickness 2 mm, echo time 86 ms, repetition time 12000 ms, matrix 128x128,~     b-value 1000 s.mm-1. An anatomic sequence hyperT2 was overlaid as reference. Distortion was~     corrected by topup and eddy functions from FSL. Cranial nerves fibers were probabilistically~     tracked with Mrtrix3. Cranial nerves were selected according to their location around the~     tumor. The radiological expected position of the cranial nerve was compared to its~     operative real position.~   "
44917|NCT02978898|"~     Background:Altered Toll-like receptor (TLR) expression levels and/or mutations in its~     signaling pathway (such as MyD88 mutation) contribute to the pathogenesis of~     lymphoproliferative disorders (LPD). CD180 is an orphan member of the TLR family that~     modulates the signaling of several TLRs, but only limited studies have evaluated its~     expression by flow cytometry (FCM) in LPD.~      Methods: Using a multiparameter FCM approach, biologists have assessed CD180 mean~     fluorescence intensity (MFI) in lymph nodes (LNs) and peripheral blood (PB) samples obtained~     from patients with follicular lymphoma (FL; LN/PB, n=44/n=15), chronic lymphocytic leukemia~     (CLL, n=26/n=21), mantle cell lymphoma (MCL, n=13/n=17), and marginal zone lymphoma (MZL,~     n=16/n=12). Specimens from non-tumoral PB and LN (n=8/n=12) were used as controls.~   "
44918|NCT02978885|"~     The aim of study is to determine if 99mTc Annexin V-128 (AxV- 128/Tc) single photon emission~     computed tomography (SPECT)-computed tomography (CT) can detect perioperative lung injury.~     The investigators will study patients undergoing major surgery, specifically Whipple~     procedures (pancreatico-duodenectomies) and compare AxV-128/Tc SPECT-CT scans before and~     after surgery in Chronic Obstructive Pulmonary Disease (COPD) and non-COPD patients.~   "
44919|NCT02978872|"~     The Quantra™ System is a novel point-of-care diagnostic device designed to perform whole~     blood coagulation analysis. This study compares Quantra measurements determined in arterial~     versus venous blood samples obtained from patients undergoing cardiac surgery.~   "
44920|NCT02978859|"~     Primary Objective:~        -  To assess the efficacy of MGCD516 in patients with advanced liposarcoma by evaluating~          the progression free rate at 12 weeks as compared historical controls.~      Secondary Objectives:~        -  To further evaluate the safety profile of MGCD516 by assessing adverse event rates~          (according to National Cancer Institute CTCAE version 4.0 criteria) in patients treated~          with this agent.~        -  To assess the efficacy of MGCD516 in patients with advanced liposarcoma by evaluating~          the overall response rate (according to RECIST 1.1 criteria), progression free survival~          and overall survival in patients treated with this agent.~   "
44921|NCT02978846|"~     This study is asking patients who are undergoing radiation therapy with or without~     chemotherapy on how well they evaluate their side effects on the last day of treatment. This~     study is not to change health outcomes of the patients in this study. Asking patients to rank~     side effects in order of which ones bother them the most may help researchers identify the~     most troubling side effects of cancer treatment.~   "
44922|NCT02978833|"~     Gluteus medius tendinopathy, which is often referred to as Greater Trochanteric Pain~     Syndrome, is characterized by pain in the lateral aspect of the hip that is aggravated by~     side lying, stair climbing, and walking. Treatment is currently limited to lifestyle~     modifications, corticosteroid injections, physical therapy, and open and endoscopic surgical~     repair. Platelet rich plasma (PRP) injections contain important growth factors that are~     essential in the healing and tissue formation processes. However, the extent to which PRP is~     more efficacious than whole blood in tendinopathy remains unclear. In this double-blind~     randomized trial, patients will be allocated to receive either a PRP or whole-blood~     injection. Post-procedure assessments will occur at 6 weeks, 3 months, 6 months, 9 months,~     and 1 year.~   "
44923|NCT02978820|"~     Scoliosis specific exercises have been shown to improve curve progression but there have been~     few studies that compare the different exercise approaches in adolescent idiopathic scoliosis~     (AIS). The objective of this study was to compare the effects of Core stabilization (CS)~     exercises with Scientific Exercises Approach to Scoliosis (SEAS exercises) in addition to~     brace wearing in patients with AIS. It is important to compare different exercise methods on~     different aspects of scoliotic deformity, such as curve progression, angle of trunk rotation,~     body symmetry, cosmetic trunk deformity, satisfaction with treatment and quality of life.~   "
44924|NCT02978807|"~     The objective of this study is to determine the most appropriate and effective approach for~     the diagnosis of gestational diabetes mellitus (GDM) among pregnant women receiving focused~     antenatal care at Moi Teaching and Referral Hospital (MTRH). This will be done through~     performing a random blood sugar, fasting blood sugar, 1 hr/2hr glucose tolerance test, and~     HbA1c on all participants who meet eligibility criteria and provide written, informed~     consent. The specific research question is: what is the most appropriate screening and~     diagnostic strategy for patients receiving antenatal care at MTRH?~   "
44925|NCT02978794|"~     With the extension of the average life expectancy, the incidence of cardiovascular diseases~     is also rising. Stroke in Taiwan has been the leading cause of morbidity and mortality, but~     also in countries around the world), stroke and the impact of socio-economic and health~     spending are large how to reduce the degree of disability after stroke is an important issue~     in medicine. For a long time, the resident will fill the clinical pathway form before the~     stroke inpatients were discharged. We also analyzed the data of clinical pathway every three~     months.~      According to the current data of stroke clinical pathway included demographic data, length of~     hospitalization days, complications, functional independent measure, Brunnstrom motor~     recovery stage, mini-mental state examination, geriatric depression scale, blood pressure~     data, and post-stroke checklist for a retrospective analysis to provide more complete and~     more comprehensive information on follow-up care for stroke patients and effective use of~     medical resources, to improve the quality of future medical care and quality of life for~     stroke patients.~   "
44926|NCT02978781|"~     This study is a three-part, multicenter, Phase 2a study to evaluate the efficacy, safety,~     tolerability, and pharmacokinetics of SAGE-217 in adult subjects with essential tremor.~   "
44929|NCT02978742|"~     Bulimia nervosa and binge eating disorder pose a public health concern due to their high~     co-occurrence with other psychiatric disorders and poor physical health outcomes. It is~     therefore concerning that less than half of these patients seek treatment for their~     condition. People may be reluctant to seek treatment due to not wanting to disclose symptoms~     to family members. Even for those who do wish to seek help, treatment is often inaccessible~     due to the geographic centralization of eating disorder specialists and a low ratio of~     specialists to patients. Therefore, the aim of this study is to test a potential solution to~     these problems and make eating disorder care more private and accessible.~      One possible way to improve the accessibility of treatment is through smartphone applications~     (or apps). We are testing an app called Recovery Record, which is primarily a tool used to~     self-monitor eating habits, where patients record their meals and related thoughts, feelings,~     emotions, and behaviours (e.g., binge eating/purging). The app also offers additional~     features such as discrete reminders to log meals, positive reinforcement, social support,~     coping strategy suggestions, and linking users with clinicians for real-time feedback and~     suggestions. The application is scientifically supported and has been tested with positive~     results.~      Recently, app developers have created a computer-automated 8-week treatment program that uses~     the patient's data to provide a tailored and individualized treatment program. This program~     aims to mimic the process of therapy by checking in with users, reminding them of their~     reasons for wanting to recover, and working towards goals. We will be testing this automated~     app treatment program, comparing it both with and without input from a trained coach~     providing individualized feedback to users.~   "
44930|NCT02978729|"~     The purpose of this study is to compare two methods for remote genetic counseling (telephone~     and two-way videoconferencing) for patients who are receiving disclosure of their APOE~     (apolipoprotein E) genotype. The target population will consist of males and females in the~     age range of 60-75 years who, as potential participants in a study (Generation Study), will~     need to receive genetic counseling and disclosure of APOE genotype. Subjects must be willing~     to receive genetic counseling and disclosure remotely. Subjects must be willing to be~     randomized to either telephone arm or videoconference arm.~   "
44931|NCT02978716|"~     This is a study to investigate the potential clinical benefit of trilaciclib (G1T28) in~     preserving the bone marrow and the immune system, and enhancing chemotherapy antitumor~     efficacy when administered prior to carboplatin and gemcitabine (GC therapy) for patients~     with metastatic triple negative breast cancer.~      The study is open-label and approximately 90 patients will be randomly assigned (1:1:1~     fashion) to 1 of the 3 following treatment groups:~        -  Group 1: GC therapy (Days 1 and 8 of 21-day cycles) only (n=30)~        -  Group 2: GC therapy (Days 1 and 8) plus trilaciclib (G1T28) on Days 1 and 8 of 21-day~          cycles (n=30)~        -  Group 3: GC therapy (Days 2 and 9) plus trilaciclib (G1T28) on Days 1, 2, 8, and 9 of~          21-day cycles (n=30)~      The study will include 3 study phases: Screening Phase, Treatment Phase, and Survival~     Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and~     completes at the Post-Treatment Visit.~   "
44932|NCT02978703|"~     Observational study for the evaluation of clinical effectiveness in daily clinical practice~     of inhaled combination of propionic Fluticasone and Salmeterol in doses (500+50)mcg -~     Rolenium- administered with Elpenhaler device in approximately 2000 COPD (Chronic Obstructive~     Pulmonary Disease) patients with a FEV1 <50% predicted normal (pre-bronchodilator), a history~     of repeated exacerbations and who have significant symptoms despite regular bronchodilator~     therapy in Greece.~   "
44933|NCT02978690|"~     This is a phase I, open label, single group study that is being performed to assess the~     safety, tolerability, Pharmacokinetics (PK) , Pharmacogenomics (PGx) and efficacy of a single~     dose of BI 655130 in adult patients with active Generalized Pustular Psoriasis (GPP).~   "
44934|NCT02978677|"~     The trial evaluates the effect of a moderately increased radiation dose in patients with~     atypical (grade II) and anaplastic (grade III) meningioma after incomplete or no surgery.~     Endpoint is recurrence-free survival after 5 years.~   "
44935|NCT02978664|"~     The investigators will review video-recordings of three randomized, controlled trials~     (NCT01535326, 01699399, and 01894191) comparing air insufflation, water immersion and water~     exchange during colonoscopy. These studies were all conducted at Buddhist Dalin Tzu Chi~     Hospital.~   "
44936|NCT02978651|"~     The first objective of this study is to demonstrate the efficacy and safety of pitolisant~     given at 10, 20, or 40 mg per day versus placebo during 12 weeks of the Double Blind period,~     to treat the Excessive Daytime Sleepiness (EDS) in patients with Obstructive Sleep Apnea~     (OSA) refusing the nasal Continuous Positive Airway Pressure (nCPAP) therapy or treated by~     nCPAP but still complaining of EDS.~      The secondary objectives of the study include assessing the long-term tolerance as well as~     the maintenance of efficacy of pitolisant given at 10, 20 or 40 mg per day during 39 weeks of~     Open Label Extension period.~   "
44937|NCT02978638|"~     This study aims to improve continence of patients with spinal cord injury using electrical~     stimulation.~      The Finetech Vocare Bladder System is an implantable sacral nerve stimulator for improving~     bladder and bowel function in patients with spinal cord injury (SCI). It has been~     commercially available in Britain and other countries since 1982, and has been used in~     thousands of patients with SCI to improve bladder, bowel and sexual function. It received FDA~     approval in 1998 under Humanitarian Device Exemption H980005 and H980008 for providing~     urination on demand and to aid in bowel evacuation.~      Electrical stimulation to produce bladder contraction and improve bladder voiding after~     spinal cord injury has usually been combined with cutting of sensory nerves to reduce reflex~     contraction of the bladder, which improves continence. However, cutting these nerves has~     undesirable side effects. This study will not cut any sensory nerve. This study is testing~     the use of the stimulator for inhibiting bladder contraction by stimulating sensory nerves to~     improve continence after spinal cord injury.~   "
44938|NCT02978625|"~     This phase II trial studies how well talimogene laherparepvec works and nivolumab in treating~     patients with lymphomas that do not responded to treatment or non-melanoma skin cancers that~     have spread to other places in the body or do not responded to treatment. Biological~     therapies, such as talimogene laherparepvec, use substances made from living organisms that~     may stimulate or suppress the immune system in different ways and stop tumor cells from~     growing. Monoclonal antibodies, such as nivolumab, may block a protein needed by tumor cells~     to grow and spread. Giving talimogene laherparepvec and nivolumab may work better in treating~     patients with lymphomas or non-melanoma skin cancers.~   "
44944|NCT02978547|"~     This is a single arm, non-randomized phase II study of neoadjuvant metformin in resectable~     PDAC. Twenty patients will be enrolled and treated with metformin 500 mg BD for a minimum of~     7 days, until 2 days prior to surgery. Patients will undergo laboratory investigations at~     baseline, prior to surgery and 4-10 weeks after surgery. Patients eligible for and consented~     to the optional MRI substudy will undergo diffusion-weighted MRI 1 to 14 days before surgery.~      At surgery, resected tumour and normal tissue will be collected and banked. FFPE specimens~     will be used for sectioning, histological analysis and IHC for Ki67 (cell proliferation~     marker), pAMPK, ACC targets, p53 and mTOR targets, apoptotic markers (Bax, Bcl-2, caspases 3,~     8 and 9). Fresh frozen tumour and matched normal tissue samples will be used for western blot~     analysis of insulin and IGF receptors, total and activated ERK and Akt, and RNAseq analysis.~     Pre-metformin biopsy samples will be retrieved for molecular analysis.~      Fasting blood samples at baseline and before surgery will be analyzed for glucose and insulin~     levels. Plasma and whole blood will also be processed and banked for circulating tumour DNA~     analysis. Urine samples will be sent for metabolomic profiling.~   "
44945|NCT02978534|"~     The widespread and common use of quetiapine in childbearing and pregnant women demands more~     data to inform dosing and toxicity in pregnancy. The new FDA Pregnancy and Lactation Labeling~     Final Rule (PLLR) will go into effect on June 30th, 2015 and will replace the prior A, B, C,~     D, and X categories. Additionally, the PLLR will require information to aid prescribing~     decisions in three categories 1) Pregnancy (including labor and delivery), 2) Lactation, and~     3) Females and Males of Reproductive Potential. The pregnancy category will include a~     subsection that will describe pharmacokinetic and pharmacodynamic characteristics of the~     medication in pregnancy, fetal risk, and data quality. The data collected in this study will~     update the FDA pregnancy pharmacokinetic section for quetiapine and inform physicians that~     prescribe to childbearing women.~   "
44946|NCT02978521|"~     Lung cancer (LC) is usually diagnosed in advanced stages and continues to be the leading~     cause of cancer related deaths worldwide. Cancer cachexia are frequent among patients with LC~     affecting up to 80% of patients with advanced stage disease, and it has been related with~     higher risk of complications, length of hospital stay, and worst overall survival. During~     cancer cachexia, both muscle and fat mass can be wasted, however, the loss of muscle mass has~     been associated to higher treatment related toxicity, loss of functional status, shorter~     progression free survival and overall survival in different types of cancer under various~     treatments. Hence, preservation of muscle mass and function should be an important focus of~     the multidisciplinary treatment of patients with LC.~      Pulmonary rehabilitation (PR) has been known to improve pulmonary function, reduce fatigue~     and improve exercise tolerance in patients with LC undergoing curative surgery. However, few~     studies have focused on the efficacy of PR on patients with advanced cancer undergoing~     palliative care with chemotherapy or targeted therapies.~   "
44947|NCT02978508|"~     This is a multi-center, double-blind, randomized, two arm parallel design study. This study~     is comprised of two phases: screening and treatment. The screening period will be up to 5~     days, followed by the treatment phase of 28±4 days. During the treatment phase subjects will~     be randomized to receive either test or reference treatments in a double-blind manner in an~     outpatient setting. Randomization of subjects will be in a 1:1 ratio for the test and~     reference drug arms and will be stratified by site.~      Screening will begin at visit 1, during which eligibility will be determined and prohibited~     treatments will be discontinued. Randomization will occur following the confirmation of the~     eligibility criteria at visit 2 (baseline, Day 1) i.e. initiation of treatment phase. The~     treatment phase will be 28±4 days in duration wherein subject will receive treatment with~     investigational product (either test or reference) on Day 1 or Baseline (visit 2). Safety and~     tolerability assessments will be performed on Day 7 (visit 3). Efficacy, safety and~     tolerability will be assessed on Day 14 (visit 4) followed by the End of study visit on Day~     28 (visit 5). If positive identification of scabies is confirmed at Day 14 (visit 4), the~     subject will be retreated with the second application of the investigational product.~   "
44948|NCT02978495|"~     Breast cancer is the most frequent neoplasm in women in Brazil and in the world and up to 15%~     of all cases diagnosed correspond to the triple negative subtype. Triple negative breast~     cancer affects young women with germline mutations in BRCA 1/2 genes. Giving the lack of~     target therapies to date, there is no consensus regarding the most effective treatment for~     this subgroup of tumors. Although evidence shows that triple negative breast cancer is highly~     sensitive to chemotherapy when compared to other breast tumors, there is no evidence to~     support the hypothesis that patients with triple negative breast cancer and mutation in BRCA1~     / 2 genes have higher chemosensitivity to neoadjuvant therapy. The investigator proposes a~     prospective, randomized, open-label, phase II study, evaluating the rate of complete~     pathologic response, disease-free survival, overall survival and prognostic evaluation of~     BRCA1 / 2 mutation status in women with triple negative breast cancer submitted to sequential~     neoadjuvant chemotherapy based on anthracycline and taxane, with or without carboplatin.~   "
44949|NCT02978482|"~     A Phase 1/2 Open-label, Multi-center Study to Evaluate the Safety, Tolerability,~     Pharmacokinetics, and Anti-tumor Activity of Durvalumab (MEDI4736) in combination with~     tremelimumab in Chinese Patients with Advanced Malignancies~   "
44950|NCT02978469|"~     Long hours of daily sitting and lack of Physical Activity (PA) are risk factors for morbidity~     and mortality.~      People with movement disabilities, including adolescents with Cerebral Palsy (CP) tend to~     lead a sedentary life styl and have have poor physical fitness. Adolescents with CP where~     found to be inactive most of the day thus, they are in greater risk of disease than the~     general population. In addition, over the years, people with disabilities experience physical~     and functional deterioration. Reducing sedentary behavior and increasing daily activity can~     reduce health risk factors among the adolescents with CP, reduce secondary impairments and~     preserve function.~      Interventions that included exercise alone has not resulted in physical activity and~     participating in a structured training did not continue after cessation intervention.~      The objectives of this study are to establish effective programs aiming to promote an active~     life style among adolescents and young adults with CP and to evaluate there outcomes.~      Specific objectives- Stage 1- Identifying barriers and facilitators for reducing sedentary~     behaviors and increasing physical activity among adolescents and young adults with CP. As~     well as, identifying mediators, needs and preferences for reducing sedentary behaviors and~     increasing physical activity among adolescents and young adults with CP.~      Stage 2- Based on stage 1- Establishing an intervention for reducing sedentary behaviors and~     increasing physical activity among adolescents.~      Stage 3- translating and developing questioners for the study.~        -  Translating the ASK-Performance and the ASK-Capability questionnaires to Hebrew and~          validating the Hebrew translation.~        -  Developing a self-efficacy perception questioner for increasing physical activity and~          reducing and sedentary behavior.~        -  Translating to Hebrew, adjusting and validating an activity diary.~      Stage 4- evaluating the effectiveness of the proposed intervention program on reducing~     sedentary behaviors and increasing physical activity among adolescents and young adults with~     CP.~   "
45656|NCT02969252|"~     The objective of the study was to evaluate the pharmacokinetics and the safety of rifamycin~     SV after single and multiple doses of Rifamycin SV-MMX® 600 mg tablets administered to male~     and female healthy subjects.~   "
44952|NCT02978443|"~     Participants with advanced or metastatic mucosal melanoma (cohort A) and acral lentiginous~     melanoma (cohort B) eligible for treatment with nivolumab in combination with ipilimumab~     followed by nivolumab therapy will submit tissue blocks from tumors of malignant melanoma for~     histopathology review and immunohistochemistry analysis at Georgetown University-Lombardi~     Comprehensive Cancer Center. Pretreatment blood will be drawn and stored in the Melanoma~     Research Foundation Breakthrough Consortium Virtual Repository at each participating~     institution. At the end of participation, samples will be sent to Georgetown~     University-Lombardi Comprehensive Cancer Center for processing and storage. An optional~     pretreatment biopsy of an accessible tumor lesion will be performed in a subset of enrolled~     patients. Patients will receive nivolumab in combination with ipilimumab according to the~     standard FDA approved treatment regimen.~   "
44953|NCT02978430|"~     The aim of this study is to compare the implementation of computer-assisted goal directed~     fluid therapy (GDFT) to standard of care fluid therapy in major abdominal surgery.~   "
44954|NCT02978417|"~     In preparation for a large-scale randomized controlled trial (RCT) of Vivitrol® effectiveness~     in drug courts, investigators propose a feasibility study in the Wake County, North Carolina~     drug court, where an estimated 50% of clients are opioid dependent.~      Aim 1: Pilot RCT. Pilot-test the delivery of Vivitrol® treatment for 10-20 interested and~     eligible clients of the Wake County Drug Court.~   "
44955|NCT02978404|"~     Stereotactic radiosurgery (SRS) is increasingly administered as the sole treatment of brain~     metastases, in order to spare acute and long term side effects associated with whole brain~     radiotherapy. Local control of SRS treated lesions is good, but patients tend to develop~     additional brain metastases subsequently.~      Nivolumab is a modulator of the immune system. Treatment with Nivolumab is associated with an~     increase in local control and survival in patients with non-small cell lung cancer and clear~     cell renal cell carcinoma. In the presence of Nivolumab, treatment of brain metastases with~     SRS may trigger an immune reaction against cancer. Therefore, the combination of SRS with~     Nivolumab may reduce the development of new brain metastases and improve patient survival.~      The purpose of this study is to assess the effect of combining Nivolumab and SRS in~     controlling cancer progression. SRS will be administered to patients while they are receiving~     Nivolumab.~   "
44956|NCT02978391|"~     UI-EWD (NextBiomedical Co, Incheon, South Korea), a new hemostatic powder for endoscopic~     treatment of high-risk bleeding peptic ulcers and bleeding after ESD/EMR.~      Several endoscopic hemostasis methods are currently in use. UI-EWD (Endoscopic Wound~     Dressing) is adhesive absorbable powder as a new hemostasis material, the therapeutic effect~     and safety in endoscopic application will be verified. This study has been designed to~     observe comparing UI-EWD versus the submucosal epinephrine injection for endoscopic~     hemostasis of bleeding peptic ulcers and bleeding after EMR/ESD.~   "
44957|NCT02978378|"~     The investigators objective is to assess the utility of renal biomarkers in predicting renal~     recovery following institution of Venoarterial Extracorporeal Membrane Oxygenation (VA-ECMO).~     Tissue biomarkers of renal injury may provide a real-time indication of renal function and~     the likelihood of renal recovery in patients having cardiogenic shock and requiring VA-ECMO.~     In these patients, traditional markers of kidney function (urine output and serum Creatinine~     level) do not accurately represent renal function.~   "
44958|NCT02978365|"~     Case control study to evaluate different factors (e.g muscle strength, psychological factors)~     that are associated with full recovery and functional status 6 months after surgical repair~     of shoulder instability.~   "
44959|NCT02978352|"~     Delirium is an acute and fluctuating disturbance of consciousness characterized by reduced~     attention, impaired cognition and perception, usually resulting from general physical~     conditions. Delirium contributes to longer hospital length of stay, increased mortality,~     increased healthcare costs, and long-term cognitive and functional impairment. However, it is~     often underdiagnosed and undertreated. E-learning (electronic learning) proves to be a~     time-efficient, flexible and convenient training method, making it suitable for a large~     organization like Siriraj hospital where there is a large employee turnover rate. So the~     investigators want to compare the passing rate between the e-learning group and the~     traditional learning group.~   "
44960|NCT02978339|"~     The purpose of this study is to determine whether curcumin, a drug and naturally-occurring~     plant compound, is safe and effective in the treatment of primary sclerosing cholangitis~     (PSC).~   "
44961|NCT02978326|"~     This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of~     the efficacy, safety and pharmacokinetics of SAGE-217 in up to 140 adult female subjects~     diagnosed with severe postpartum depression.~   "
44962|NCT02978313|"~     Investigating the efficacy of Cetuximab Monotherapy versus Continuation after induction~     treatment with chemotherapy + Cetuximab in inoperable or irresectable and non-progressive~     metastatic colorectal cancer after first line induction treatment for 24 weeks with~     mFOLFOX6/FOLFIRI and Cetuximab treatment. Reinduction treatment will be done in case of~     progression.~   "
44963|NCT02978300|"~     Acute respiratory failure is the leading cause of ICU admission of immunocompromized~     patients. In this subgroup of patients, the need for intubation and invasive mechanical~     ventilation occurs in about 50% of cases and is associated with very a high mortality rate,~     reaching 70% of cases. Therefore, noninvasive oxygenation strategies have been developed to~     avoid intubation.~      More than 15 years ago, 2 trials have suggested that NIV could decrease intubation and~     mortality rates of immunocompromized patients as compared to standard oxygen through a mask.~     However these results have not been confirmed in a recent large trial.~      HFNC is a recent and well-tolerated oxygenation technique. In a recent trial, HFNC alone~     could decrease mortality and intubation rates in patients with ARF as compared to NIV.~     Similar findings have been reported in a post-hoc analysis on immunocompromized patients~     excluding those with profound neutropenia. Likewise in a retrospective monocentric cohort of~     immunocompromized patients, we reported better outcomes with HFNC than with NIV.~   "
44964|NCT02978287|"~     The aim of this study is to measure of the parathyroid cell viability and the the amount of~     calcium sensing receptor of the parathyroid cells which were placed into a new transportation~     solution (BAVU solution) for parathyroid allotransplantation.~   "
44965|NCT02978274|"~     Patients undergoing haploidentical allo-HSCT will be prospectively enrolled exploring the NK~     cells phenotype and functional reconstitution.~   "
44967|NCT02978248|"~     ARENA aims to inform patients about the symptoms and the risks of atrial fibrilation.~      The study design includes three study arms:~        1. ARENA Intervention: This project will examine the effectiveness of population education.~        2. ARENA Medication: The aim is to examine the patient's adherence and to analyze whether~          there are any complications.~        3. ARENA Migration: ARENA migration aims to examine whether a targeted population education~          can improve the care of people with a Turkish migration background.~   "
44968|NCT02978235|"~     The Phase 1 portion of this study will determine the safety of TAS4464 and the most~     appropriate dose for patients with Multiple Myeloma or Lymphoma. The Phase 2 portion of the~     study will investigate the efficacy and safety of TAS4464 in patients with Multiple Myeloma~     or Lymphoma~   "
44969|NCT02978222|"~     This is a double-blind, randomized, parallel groups Phase II trial. Patients with~     platinum-sensitive advanced ovarian cancer, defined as a lack of progression by RECIST v1.1~     criteria following completion of standard-of-care chemotherapy, including a minimum of 4~     cycles of a platinum-containing regimen. Patients will be randomized to either the vaccine~     regimen with GM-CSF adjuvant or GM-CSF adjuvant alone as a control group. Treatment will be~     administered as a consolidation therapy within one year of the last administration of~     platinum, targeting the first remission.~   "
44970|NCT02978209|"~     A randomized double blinded clinical trial will be conducted comparing the effect of three~     simple basic moisturizers only different in the concentration of carbamide (urea). Three~     concentrations of carbamide will be tested, 5, 7.5, and 10 %, respectively. The study will be~     conducted as a split-body-study and will contain three arms randomized to comparing 5 and 7.5~     %, 5 and 10 %, and 7.5 and 10 % carbamide, respectively. 20-30 patients with at least~     clinically verified Ichthyosis Vulgaris will be enrolled to each study arm. The effect of the~     moisturizers will be assessed by clinical examination (score), patients assesment of effect~     and measurement of transepidermal water loss (TEWL) and other skin parameters.~   "
44971|NCT02978196|"~     To evaluate the efficacy and safety of 99m-Tc labeled anti-PD-L1 VHH for SPECT/CT diagnostic~     imaging of Non-Small Cell Lung Cancer and compare it with the existing gold standard biopsy~     PD-L1 detection. It is also to establish a new method of clinical diagnosis of NSCLC using~     99m-Tc labeled anti-PD-L1 VHH.~   "
44972|NCT02978183|"~     The purpose of this study is to evaluate the efficacy of ST266 ophthalmic drops compared to~     placebo for the treatment of the signs and symptoms of allergic conjunctivitis.~   "
44973|NCT02978170|"~     The goal of this clinical research study is to find out if adding a Cone-Beam CT (CBCT) scan~     during a scheduled bronchoscopy can help researchers biopsy lung lesions that are harder to~     reach.~      CBCT is a newer type of CT scan that researchers will use to make sure the tools used to~     biopsy these lesions (called a bronchoscope and a radial probe-EBUS [RP-EBUS]) are in the~     right location. The safety and feasibility of adding this extra scan to a standard~     bronchoscopy will also be studied.~   "
44974|NCT02978157|"~     From the profiles of antibiotic susceptibility data following eradication therapy,~     tetracycline, amoxicillin and levofloxacin are all good candidates of antibiotics used in the~     rescue treatment.~   "
44975|NCT02978144|"~     This will be a prospective study examining the use of 99mTc-Annexin V-128 (AxV-128/Tc)~     single-photon emission computed tomography (SPECT)/computerized tomography (CT) technology in~     the imaging and functional assessment of the lung of patients with chronic obstructive~     pulmonary disease (COPD), healthy volunteer smokers without COPD and healthy volunteer~     subjects without smoking history. The aim of study is to determine if patients with COPD have~     an increased AxV-128/Tc signal with SPECT/CT.~   "
44976|NCT02978131|"~     Tuberculosis (TB) remains a major public health problem nowadays. About 30% of the world~     population is infected with Mycobacterium tuberculosis. There is an increase in the number of~     cases of classic tuberculosis in developing countries, even if number of cases are declining~     in developed countries. However, in developed countries this decrease is counterbalanced by~     the emergence of multidrug resistant (MDR) strains of the bacteria.~      There are also latent forms (1/3 of the world population) of the infection that can be~     reactivated in one case out of ten. Each year, about 2 million people die of tuberculosis and~     9 million new cases are identified, including about 500,000 cases of MDR TB.~      The spread of this disease as well as the increasing number of cases of MDR tuberculosis,~     reinforce the need for research and development of strategies of diagnosis and management of~     this affection.~      Nowadays, the culture is the gold standard for the TB diagnosis but this technique needs at~     least three weeks to be performed. The objective of this study is to evaluate the sensitivity~     and specificity of histopathological and molecular techniques (PCR) on paraformaldehyde fixed~     and embedded in paraffin tissues for a faster diagnosis of tuberculosis in current practice,~     in order to administrate an efficient treatment as soon as possible.~   "
44977|NCT02978118|"~     This pilot study purpose of this study is to describe peripheral circulating immune cell~     profiles at baseline and change on treatment with immune checkpoint inhibitors in renal cell~     carcinoma and urothelial carcinoma.~   "
44978|NCT02978105|"~     The investigators hypothesized that hypnosis is an alternative technique that could be~     applied to help patients with obesity to lose weight.~      The possibility that a self-conditioning technique (self-hypnosis) added to traditional~     approach (diet, exercise and behavioral recommendations) will be effective in determining~     weight loss with respect to the traditional approach in subjects with a body mass index (BMI)~     between 35 and 50 kg/m2 will be studied.~   "
44979|NCT02978092|"~     Retrospective, analysis of three different methods to measure patients' pupil diameters~   "
44980|NCT02978079|"~     Horner's syndrome (HS) is a result of interruption of the sympathetic innervation to the eye~     and ocular adnexa, which can occur due to carotid artery dissection (CAD), along which the~     sympathetic nerve fibers travel to reach the eye. Dissection of the carotid artery is one of~     the etiologies for ischemic stroke in young patients.~      In our current study, we will explore the diagnostic accuracy of automated binocular~     pupillometry in the diagnosis or HS, and its potential in identifying dissection of the~     carotid artery in patients of young age who suffer ischemic stroke.~   "
45657|NCT02969239|"~     The purpose of this study is to compare norepinephrine and phenylephrine on the effects of~     maintaining the cardiac output in Cesarean section under spinal anesthesia.~   "
44981|NCT02978066|"~     Patients, scheduled for elective arthroplasty were monitored with Lithium Dilution Cardiac~     Output monitor (LiDCOplus™) before and 45 minutes after spinal anesthesia. Hypotension was~     defined as systolic blood pressure ≤ 100 mmHg or ≥ 30% decrease from baseline. Associations~     between hypotension and the hemodynamic changes after preanaesthetic fluid loading and spinal~     anesthesia were analysed by logistic regression analyses.~   "
44982|NCT02978053|"~     This project examines 1) the effects of appropriately timed bright light on adaptation (in~     terms of sleep and sleepiness) to three consecutive night shifts; and 2) the effects of such~     bright light on re-adaptation (in terms of sleep and sleepiness) to a day-oriented schedule~     after the night shift period.~   "
44983|NCT02978040|"~     Primary percutaneous coronary intervention (PCI) is the main reperfusion therapy in patients~     with ST-elevation myocardial infarction (STEMI). The optimal platelet inhibition at the time~     of PCI is fundamental, however, the comparative speed of action of cangrelor as opposed to~     tirofiban and to chewed or integer loading dose of prasugrel is unknown.~      The purpose of this trial is to assess the inhibition of platelet aggregation with different~     regimens on platelet inhibition (tirofiban bolus+infusion, cangrelor bolus+infusion,~     prasugrel chewed loading dose, prasugrel integer loading dose) in the early phase of primary~     PCI.~   "
44984|NCT02978027|"~     The NIAAA estimates that 16% (40 million) of adults in the US are drinking at unsafe levels.~     More than 50% of alcohol health consequences occur in risky, non-dependent drinkers.~     Increasing the efficacy and efficiency of brief interventions in medical setting could~     significantly reduce the public health impacts of risky drinking. There is intense interest~     in conducting motivational interviewing (MI) informed brief interventions for risky alcohol~     use in medical settings, but little empirical information is available regarding which MI~     behavioral and interpersonal style components drive effectiveness. The field would benefit~     greatly from empirically-based Stage 1 treatment development and modeling studies to~     delineate the degree to which adding motivational interviewing components to brief~     intervention improves outcome.~   "
44985|NCT02978014|"~     A two-arm randomised controlled trial in patients receiving post-prostatectomy radiotherapy~     in the adjuvant or salvage setting, with patients randomised to receive daily ProSpare~     (obturator) guided IMRT or Centre standard (non-obturator) guided IMRT.~   "
44986|NCT02978001|"~     The pathophysiological mechanisms explaining the association between psoriasis and type 2~     diabetes are largely unknown but it has been hypothesized that systemic inflammation found in~     both psoriasis and type 2 diabetes might play a role. In a recent study hyperinsulinaemic~     euglycaemic clamps were performed and it showed that normal glucose-tolerant patients with~     moderate to severe psoriasis had lower whole-body insulin sensitivity during insulin~     stimulation compared to healthy matched controls. Thus, the increased risk of type 2 diabetes~     in patients with psoriasis appears to include defects in the glucose metabolism linked to~     psoriasis itself. However, the methods applied did not allow a detailed characterization of~     the metabolism in patients with psoriasis. Tracer technique combined with indirect~     calorimetry has never been applied to study hepatic and whole body insulin sensitivity, and~     glucose and fat oxidation, during basal conditions or during insulin stimulation in patients~     with psoriasis.~      Aim of study:~      The aim of this study is to investigate hepatic and whole body insulin sensitivity and~     glucose and fat oxidation during both basal and insulin-stimulated conditions in patients~     with psoriasis.~   "
44987|NCT02977988|"~     Approximately 25 million Americans struggle with alcohol or drug problems annually. Abuse of~     alcohol and drugs is costly to our nation, exacting more than $428 billion in costs related~     to crime, lost work productivity and health care. While effective treatments exist, over half~     of those who enter treatment for substance use disorders drop out early in treatment and~     return to alcohol or drug abuse. Psychological stress is a causal factor in the pathogenesis~     of substance use disorder (SUD) and relapse risk. Low-income women report high levels of~     stress in SUD residential treatment stemming from significant economic and family stressors~     in addition to challenges of adjusting to residential treatment demands. Unmanaged stress,~     especially in early stages of residential treatment, is a major concern because it can~     increase dropout. Dropout from residential treatment places women at risk of substance use~     relapse. A gap in knowledge persists regarding the use of mindfulness-based interventions~     with racially/ethnically diverse low-income women with SUDs, especially regarding the~     efficacy of adapted (Mindfulness-based interventions) MBIs for preventing residential dropout~     and decreasing relapse. We have fully adapted, developed, and pilot tested a novel MBI,~     Moment-by-Moment in Women's Recovery: Mindfulness Based Relapse Prevention for Women~     (MBRP-W), that supports the needs of women in residential treatment. This MBI integrates~     relapse prevention, addresses literacy level, and is relevant to issues surrounding~     treatment- and relapse-related stressors of disadvantaged women. The current project has~     three specific aims: (1) to test the efficacy of MBRP-W on residential treatment retention~     and substance use relapse in racially/ethnically diverse low-income women; (2) to determine~     the mechanisms of change underlying the MBRP-W program; and (3) to explore neural changes~     associated with program effects. A rationale for MBRP-W is the need for self-initiated stress~     management skills in women with SUDs during the early stressful periods of residential~     treatment that increase risk of dropout and relapse.~   "
44988|NCT02977975|"~     The aim of the present study is to assess the efficacy of traditionally fermented sauerkraut~     in the treatment of irritable bowel syndrome.~   "
44989|NCT02977962|"~     Autism spectrum disorders (ASD) affect approximately 1.1% of late adolescents and young~     adults, making it one of the most common neurodevelopmental disorders. Comorbid anxiety~     disorders affect many higher-functioning adolescents and young adults with ASD, causing~     substantial distress and impairment over and above that caused by an ASD diagnosis alone.~     While cognitive-behavioral therapy (CBT) is a first-line treatment for anxiety disorders~     among typically developing late adolescents, and work by the investigative team supports its~     utility in children with ASD and comorbid anxiety, very few evidence-based treatment~     approaches exist for late adolescents with ASD and comorbid anxiety. Accordingly, the~     investigators are proposing to develop a CBT protocol for clinical anxiety that is~     personalized to the unique clinical characteristics of late adolescents (ages 16-21 years)~     with ASD namely, the Treatment of Anxiety in Late Adolescents with Autism (TALAA).~   "
44990|NCT02977949|"~     There are few reports concerning to the seasonal variation of osteoporosis treatment. In this~     study, we plan to compare clinical efficacy and safety by seasons.~   "
44991|NCT02977936|"~     The aim of the study is to evaluate at 3 months the effect of a supplementation with extracts~     of Curcuma longa, Boswellia serrata and Porphyra umbilicalis on the acceptability of pain for~     patients suffering from gonarthritic pain.~   "
45187|NCT02975388|"~     This is a multi-center, non-randomized, open-label, two-part study to investigate the effect~     of renal function and hemodialysis on PK of RO7079901. Part 1 will be conducted in adult male~     and female participants with stable mild, moderate or severe renal impairment and a control~     group of participants with normal renal function. Part 2 will be conducted in adult male and~     female participants with stable end-stage renal disease undergoing hemodialysis.~   "
44992|NCT02977923|"~     Children with injuries, including burns, experience severe pain intensity during medical~     procedures despite the increasing doses of analgesics. Current guidelines on pediatric~     procedural pain management recommend the combination of non-pharmacological and~     pharmacological interventions to enhance pain management and decrease the numerous side~     effects of analgesics. Virtual reality (VR) has gained growing consideration as a~     non-pharmacological method as it engages multiple senses and allows interactions with a~     virtual world. Oculus Rift ® (OR) is a new technology in VR that provides more immersiveness,~     at a relatively low cost, and could probably improve the management of pain and anxiety in~     wound care.~      Overall hypothesis: Distraction by VR via the OR, in combination with the standard~     pharmacological treatment, is a feasible, acceptable and satisfactory method for the~     management of pain and anxiety during wound-related treatments in children with injuries.~      Note that this pilot study will precede a larger trial aimed at assessing the effect of~     virtual reality distraction via the Oculus Rift ® (DREAM-T: NCT02947243)~   "
44993|NCT02977910|"~     Ankle fracture is very common which is often combined with deltoid ligament injury. Although~     the incidence of deltoid ligament injury is high, but there is no unified and effective~     diagnosis method. Even whether the ankle fracture with deltoid ligament rupture needs~     surgical repair is still controversial. There is no high-level, multi-center, large sample,~     long-term follow-up clinical evidence to prove whether the repair of deltoid ligament is~     necessary or not. The main content of the project: 1 Achieve accurate classification of~     deltoid ligament rupture with intraoperative exploration. 2 Study the surgical indications~     and treatment guidelines by comparative study.~   "
44994|NCT02977897|"~     Prospective, observational pilot study of ten post-transplant patients presenting with~     diarrhea while taking Mycophenolate Mofetil (MMF). These patients will undergo a standard~     workup to confirm MMF induced diarrhea. A stool fecal calprotectin will be measured to~     determine if it may be helpful in confirming the diagnosis of MMF associated diarrhea. Once~     the diagnosis is confirmed, the patients will then be treated with a short course of~     subcutaneous Octreotide which has been shown to cure this type of diarrhea.~   "
44995|NCT02977884|"~     The project proposes to provide the Complete Health Improvement Program (CHIP) initially up~     to 25 adult (non-pregnant) Ohio University employees (and/ or their adult family members)~     with with diabetes / prediabetes, obesity / overweight, hypertension / prehypertension,~     atherosclerotic cardiovascular disease, or dyslipidemia in an effort to improve~     self-management and the consequences of biometric factors that can be modified by lifestyle~     changes. The CHIP program is an educationally based, lifestyle intervention program that aims~     to reduce healthcare cost, absenteeism, and increase employee productivity. The investigators~     expect that participants following the programs guidelines will lower their body mass index,~     cholesterol, reduce blood pressure and blood glucose levels, and therefore help to prevent~     chronic disease.~   "
44996|NCT02977871|"~     Cesarean section is the most common surgical procedure performed on women. Over the years~     minor variations of each surgical step have been introduced, and cesarean sections are not~     standardized and many different techniques are employed during surgery. Creation of a bladder~     flap has been an integral surgical step of the cesarean section for many years. The role of~     the bladder flap and its usefulness in cesarean section is not known well. Further, in some~     cases the bladder flap is omitted during cesarean section. The aim of the current study is to~     compare operating time and postoperative urinary symptoms in cesarean sections using either~     bladder flap or omission of flap.~   "
44997|NCT02977858|"~     This study is a single site prospective controlled trial assessing two educational~     interventions designed to educate local pediatric Primary Care Physicians (PCP) and nurses on~     collaboratively developed treatment guidelines for pediatric constipation. The study aims to~     assess the impact of an Spaced Education game to aid the implementation of the management~     guideline. PCP adherence to recommended treatment will be assessed in addition to PCP~     satisfaction with the educational methods, constipation knowledge and patient outcomes.~   "
44998|NCT02977845|"~     Effects of Qigong on symptom clusters of dyspnea, fatigue, and anxiety in Vietnamese lung~     cancer patients: A randomized control trial~   "
44999|NCT02977832|"~     Odyliresin (Iresine Celosia) is a cytochrome-flavoprotein with a powerful anti-oxydant action~     on cells, has a therapeutic effect on BPH-related LUTS, reducing symptoms, prostate volume,~     improving the patient's quality of life and eventually limiting the number of patients who~     require surgery or endoscopy after medical treatment.~   "
45000|NCT02977819|"~     As the number of older people in Europe grows, increasing healthy life years is a priority.~     As people live longer, ensuring good mental as well as physical health into later years is~     becoming ever more important. Cognitive decline, dementia (e.g. Alzheimer's Disease, AD),~     sleep disturbances and depression, all related to psychological distress and anxiety, are~     significant drivers of reduced quality of life in older adults. This project builds on~     evidence that meditation practice have the potential to downregulate these adverse factors~     and positively impact mental and neurological conditions including AD.~   "
45001|NCT02977806|"~     Conventional indirect indicators of iron status, using serum and red blood cell biomarkers,~     are confounded by inflammation from common infections in sub-Saharan Africa, a region with a~     high prevalence of iron deficiency, making the assessment of iron balance and efficiency of~     iron intervention difficult. A new method allowing accurate measurement of long-term oral~     iron absorption and allowing the estimation of iron requirements is highly needed. Such a~     novel method to quantify iron absorption and requirements using isotope dilution measurements~     in children should be validated in the present prospective observational study by~     following-up a group of 49 children given a stable iron isotope in an earlier trial. We will~     request seven blood samples within 2 years (sampling every four months) from the participants~     which will allow us to measure isotopic dilution for estimating total oral iron absorption~     over these 24 months.~   "
45002|NCT02977793|"~     The Tomey EM-4000 Specular Microscope is designed to observe and analyze corneal endothelium.~   "
45003|NCT02977780|"~     This research study is studying several investigational drugs as a possible treatment for~     Glioblastoma (GBM).~      The drugs involved in this study are :~        -  Abemaciclib~        -  Temozolomide (temodar)~        -  Neratinib~        -  CC115~   "
45004|NCT02977767|"~     Tracheotomy is requested when upper aero-digestive tracts are obstructed. This obstruction~     can have a tumour, infectious, inflammatory, traumatic or nervous origin. Most tracheotomy~     surgeries are performed for tumour-induced obstruction. Tracheotomy allows the setting of a~     respiratory flux thanks to a cannula and excludes the upper airways. The cannula is washed~     every day from once to several times depending on the patient's secretions production and it~     is usually replaced every week. The second replacement takes place about 10 days after~     surgery. Patient education takes place at every replacement in order to empower him/her and~     in consequence to increase living comfort. This empowerment is achieved at the 4th or 5th~     replacement, at best. Because of the risks and complications related to tracheotomy and~     because of the concerned vital function, the cannula replacement leads to anxiety especially~     during the first replacements. Usual patient's anxiety management consists in reassuring the~     patient during the replacement. In other situations, patients' anxiety management would be~     drugs, however due to sedative and anxiolytic drugs' adverse events and to the need to~     maintain optimal breathing, they are not used in first intention. Our choice is to use~     conversational hypnosis during cannula replacement as it has already demonstrated interesting~     effects in pain and anxiety. Conversational hypnosis does not present an induction phase like~     in so-called hypnosis, it aims at leading the patient to perceive his/her world differently~     with only a slight consciousness alteration.~   "
45005|NCT02977754|"~     The principal objective of this study is to explore the role of 18F-FDG PET in identifying~     sorafenib-induced metabolic shift in HCC, thus in predicting treatment response and disease~     outcome in advanced HCC patients candidate to systemic treatment with sorafenib.~   "
45006|NCT02977741|"~     Prospective, observational study evaluating the effect of olanzapine for the treatment of~     refractory chronic nausea and vomiting.~   "
45007|NCT02977728|"~     In this project the investigators aim to evaluate olfactory and non-olfactory function in~     patients within the first 24h following a mild traumatic brain injury (acute mTBI) and~     compare their results to a group of age and sex matched control patients suffering from an~     orthopedic injury 24h prior to testing. The investigators then aim to follow them up 1 year~     after the trauma~   "
45008|NCT02977715|"~     Monkeypox is a febrile rash illness caused by the monkeypox virus. Its natural occurrence in~     the DRC puts healthcare and frontline workers at high risk of acquiring monkeypox virus~     infections that can prevent them from performing work duties, compromise the overall~     healthcare delivery in an already fragile system, and can result in death (case fatality~     estimates are approximately 10%).~      This is an open-label prospective cohort study in up to 1,000 eligible healthcare workers at~     risk of monkeypox infection through their daily work. The study will document monkeypox~     exposure and infection in participants while concurrently evaluating the immunogenicity and~     safety of the vaccine, IMVAMUNE, in healthcare personnel in the DRC. Participation in the~     study is voluntary and open to male and female healthcare personnel ages 18 years and older~     in Tshuapa Province in The Democratic Republic of Congo who are at risk of monkeypox virus~     infection through their daily work or laboratory personnel performing diagnostic testing for~     monkeypox virus.~   "
45009|NCT02977702|"~     The primary objective of this study was to validate Total Psoas Area (TPA) measurement as an~     independent prognostic factor of overall survival in patients with pancreatic adenocarcinoma.~     Secondary objective was to describe the evolution of the TPA during the follow-up.~   "
45010|NCT02977689|"~     The purpose of this study is to found out if the drug IDH305 is safe and effective in~     subjects with IDH1 mutant grade II or III glioma that has progressed after observation or~     radiation therapy.~   "
45011|NCT02977676|"~     The aim of this study is to determine the prevalence of ventilator-associated events (VAE).~     To analyze the patients profile, morbidity and mortality compared to patients who did not~     develope VAE. The preventability of VAE will be assessed by comparing the percentage of~     adherence to the bundle of preventive measures among patients who developed and did not~     develope VAE.~   "
45012|NCT02977663|"~     1. To build an imaging biobank of 200 patients with lungcancer, including pathologic and~          molecular characteristics of the tumor (mutational status, circulating DeoxyriboNucleic~          Acid (DNA) from serum biobank…), staging of the cancer (according to the new 2016 Tumor~          Node Metastasis (TNM) status, the table that classify non-small cell lungcancer) and~          follow-up informations (Response to first-line treatment (Response Evaluation Criteria~          in Solid Tumors (RECIST)), disease-free survival, 1-3 years survival).~        2. To propose a simple severity scoring system based on tumor features such as size,~          doubling time (if available), location, amount of enhancement and necrosis. Such~          approach has been proposed for glioma evaluation (Visually Accessible Rembrandt Images~          (VASARI)) but is not available for the lung. The objective is to do better than the~          Tumor Node Metastasis (TNM) staging.~        3. To develop and evaluate an IntraVoxel Incoherent Motion (IVIM) protocol for lungcancer~          evaluation.~   "
45013|NCT02977650|"~     To evaluate the feasibility of EUS-FNA for patients taking anticoagulants without heparin~     bridge.~   "
45023|NCT02977520|"~     Cerebral aneurysm is one of the main diseases that seriously affect human health. The most~     important treatment method is surgical clipping and endovascular embolization. Not complete~     occlusion of the aneurysm is a main risk of recurrence and rebleeding after treatment. This~     study is focused on the 3D model of cerebral aneurysms and preoperative evaluation. Combined~     with the 3D model, the neurosurgeon can complete the discussion of preoperative prediction of~     aneurysms and recognize the adjacent bone, blood vessels, aneurysm directions and so on. In~     addition, the model can also be used to the young doctor's training, and the patient and~     their families can be convenient and intuitive understanding of the disease, so as to form a~     good communication between doctors and patients.~   "
45024|NCT02977507|"~     The objective of this study is to evaluate the efficacy and tolerability of Lytera 2.0 versus~     4% hydroquinone in the improvement of the appearance of moderate facial melasma.~   "
45052|NCT02977143|"~     In urologic robotic surgery with steep Trendelenburg position, maintenance of cardiac preload~     and cardiac output is important for clinical prognosis. Previous studies reported the~     positive end-expiratory pressure (PEEP)-induced increase in central venous pressure (CVP)~     could be a accurate predictor of fluid responsiveness in cardiac surgical patients. The~     authors attempt to evaluate the predictability of PEEP-induced increase in CVP as well as~     stroke volume variation in urologic robotic surgery with Steep Trendelenburg position.~   "
45014|NCT02977637|"~     Magnetic resonance (MR) imaging is performed with contrast agents to highlight the blood~     vessels and allow interpretation and diagnosis of blood vessel abnormalities. HHT (Hereditary~     Hemorrhagic Telangiectasia) is a disease of blood vessels, and can suffer fatal bleeding if~     abnormal blood vessels are not detected and treated early. Patients with HHT also require~     many imaging studies through their lifetimes for surveillance of blood vessels. Many HHT~     patients also have co-existing iron deficiency anemia from bleeding in their nose and~     gastrointestinal tract, and receive daily iron therapy.~      Ferumoxytol is an alternative MR contrast agent, which is FDA (Food and Drug Administration)~     approved for the treatment of iron deficiency anemia. In addition, it is not associated with~     the risks to the kidneys of the other agents. The use of ferumoxytol for MR imaging may~     benefit the patients who do not currently receive imaging due to the contraindications of the~     conventional contrast agents. It avoids the use of ionizing radiation. Also, the conventional~     contrast agents are associated with risks. Iodinated contrast in CT is associated with~     significant risks of kidney damage. Another imaging technique, MR, uses gadolinium based~     contrast agents. Gadolinium, if used in patients with pre existing kidney dysfunction~     (defined as GFR < 30ml/min) is associated with the development of another devastating disease~     called nephrogenic systemic fibrosis. As HHT patients will require repeated scans throughout~     their lifetimes, this study will provide them a safer alternative.~      Ten patients from the HHT clinic in whom the use of ferumoxytol as an MR agent is clinically~     indicated will be invited to participate in this study, which will determine if MR with~     ferumoxytol is able to detect and characterize vascular malformations in HHT.~   "
45015|NCT02977624|"~     Objectives - To evaluate the effectiveness of an intervention program based on~     tele-rehabilitation in stroke survivors. The aim of the intervention is to improve the~     transition from rehabilitation units to community dwelling and facilitate involvement in life~     roles in the community.~      Working hypothesis - The tele-rehabilitation based program for stroke survivors will be~     effective in:~        1. Improving function in activities of daily living, participation in occupations and~          health related quality of life.~        2. Reducing the need for outpatient clinic and rehabilitation services.~        3. The intervention achievements will be maintained in 6 months follow-up~      Methodology - Participants: Stroke survivors will be selected from patients who are referred~     to the outpatient or home-based rehabilitation unit of Maccabi health services. The~     participants will be randomly assigned into two groups: The treatment group (N=30) will~     receive the intervention program in addition to standard care, and control group- standard~     care only.~      Outcome measures:~        1. Mayo-Portland Adaptability Inventory (MPAI-4)~        2. Stroke impact Scale (SIS)~        3. The Canadian Occupational Performance Measure (COPM)~        4. A 12-Item Short-Form Health Survey (SF-12)~        5. The Zarit Caregiver Burden Scale short version~      Procedure: The intervention program includes 20 video chat sessions over 10 weeks between an~     occupational therapist and the participant, in the presence of the primary care giver. The~     virtual meetings will be conducted using The Cognitive Orientation to daily Occupational~     Performance approach. The meetings will focus on problem solving for daily life situations~     and on the ability to implement the discussed strategies for a variety of activities.~     Participants will be evaluated at baseline, after the intervention, and after 6 months.~   "
45016|NCT02977611|"~     Iron sucrose infusion is an iron replacement used to treat iron deficiency anemia (not enough~     iron in the body to make hemoglobin). Iron is a mineral that the body needs to produce~     hemoglobin, which carries oxygen in the blood. When the body does not get enough iron, it~     cannot produce enough hemoglobin and you become anemic.~      The research study is looking at the side effects of using a higher dose and faster rate of~     iron sucrose infusion than what is used in standard of care. The purpose of this study is to~     see if infusion with 500 mg of iron sucrose over a one hour time period can be done safely.~     If this can be done safely, it may reduce the total number of infusions required and the time~     for each infusion. This may be less costly and less burdensome to patients.~   "
45017|NCT02977598|"~     In this study, the investigators aimed to find out whether there is any association between~     the atherogenic index of plasma with the glucose metabolism.In this respect, apart from the~     well-known diabetic risk factors, the investigators purposed to reveal new ones.~   "
45018|NCT02977585|"~     Binary randomized peep level of Helmet CPAP (1-0). The first patient enrolled will be assign~     to treatment 1 (10 cmH2O peep level), independently from its BSS. The following patients~     enrolled will be assign to treatment 0 (5 cmH2O peep level), and consecutively up to 25~     patients at least.~        -  10 cmH2O peep, 50 L/min gas flow, fraction of inspired oxygen (FiO2) 0.5 on PICU~          admission (random 1)~        -  5 cmH2O peep, 50 L/min gas flow, FiO2 0.5 on PICU admission (random 0) If clinical and~          respiratory worsening, reduction of pH or partial oxygen arterial pressure (PaO2)/FiO2~          occurs in the following first hour after Helmet CPAP treatment start, patients enrolled~          will receive endotracheal intubation, full face mask non invasive ventilation or higher~          peep level treatment (7.5-10 cmH2O) according to clinical evaluation, if necessary.~      In investigator's experience, early worsening of severe bronchiolitis in PICU in the first~     hour of Helmet CPAP treatment with 10 cmH2O peep level leads to endotracheal intubation.~   "
45019|NCT02977572|"~     The aim of the present study was to demonstrate that an Non-Invasive Ventilation (NIV)~     performs better than a Continuous Positive Airway Pressure (CPAP) in the management of~     Cardiogenic Pulmonary Edema (CPE) within an Intensive Care Unit (ICU) setting.~   "
45020|NCT02977559|"~     The study compared the Laryngeal Tube Suction Disposable (LTS-D) with the Disposable~     Laryngeal Mask Ambu® AuraGain™ (DLMA AG) during general anesthesia in pediatric patients.~      The investigators hypothesized that the LTS-D and the DLMA AG performed similarly during~     mechanical ventilation despite differences in their structural design.~   "
45021|NCT02977546|"~     Determination of hemodynamics plays an important role in the diagnosis of chronic heart~     failure. The gold standard is intermittent thermodilution via pulmonary artery catheter~     (PAC). Because of its invasiveness, there are certain risks of this method, e.g. injuries to~     the nerves and vessels, excessive bleedings, pneumothorax, cardiac arrhythmias etc.~     Noninvasive pulse contour Analysis (NPCA) is a new method which is able to determine~     hemodynamics noninvasively via a simple finger cuff. Advantages towards pulmonary artery~     Catheterization include a lower risk and an operator-Independent easy handling. Some studies~     investigated the accuracy, precision and trending abilities of noninvasive pulse contour~     analysis during anesthesia and in the intensive care unit, but there is no data available for~     its use in patients with chronic heart failure. The investigators therefore initiated this~     Trial to verify if NPCA is suitable for Determination of hemodynamics in patients with~     chronic heart failure.~   "
45022|NCT02977533|"~     Primary Objective:~      To assess the safety and tolerability of GZ402668 after a single subcutaneous (SC) dose in~     men and women with progressive multiple sclerosis.~      Secondary Objectives:~      To assess in men and women with progressive multiple sclerosis:~        -  The pharmacokinetic (PK) parameters of GZ402668 after a single SC dose.~        -  The pharmacodynamic (PD) response to GZ402668 after a single SC dose.~   "
45025|NCT02977494|"~     Myeloma patients with renal impairment need a rapid and effective reduction of tumor burden~     to enable renal recovery, which is correlated with prognosis of the patients. However,~     effective combination regimens are often hampered by necessary dose reductions or increased~     toxicity in renally impaired patients. The well known positive effects on renal impairment by~     Bortezomib combined with Daratumumab, which, as all monoclonal Antibody, is not renally~     excreted or metabolized and as so far known should not add significant toxicity but efficacy,~     makes the proposed combination of Daratumumab, Bortezomib and Dexamethasone highly attractive~     for renally impaired MM patients.~      In the current clinical trials with Daratumumab patients with renal function impairment (GFR~     ≤ 20 ml/min) were so far excluded. Consequently questions about efficacy, safety and~     pharmacokinetics of Daratumumab in combination with Bortezomib and Dexamethasone in patients~     with relapsed and refractory MM and severe renal impairment are still unanswered. This trial~     will answer these questions for a patient group, who has still an unmet need for novel and~     effective treatment options~   "
45026|NCT02977481|"~     Ear thermometers are often requested to be used rather than rectal thermometer (gold~     standard) for measuring the body temperature, as this method is faster and more user~     friendly. Former ear thermometers did not meet the required standards of accuracy for~     clinical use. However, a new generation of ear thermometers have been developed and widely~     used in the Emergency departments in Denmark. The devices have only been evaluated in two~     studies on adult populations, with conflicting results.~      This cross-sectional study will examine patients by measuring both ear and rectal temperature~     in the same patient at the same time on admission to an emergency department, to evaluate if~     temperature measured in the ear can be used as the standard temperature measurement.~   "
45027|NCT02977468|"~     Assess response to pembrolizumab in both primary tumor, normal breast stroma, circulating~     lymphocytes and serum exosomes in treatment naive triple negative breast cancer (TNBC)~     patients.~      Assess for change in tumor-infiltrating lymphocytes (TILS) both stromal (sTILS) and~     intraepithelial (iTILS) in newly diagnosed early stage TNBC patients treated with two doses~     of MK-3475 prior to lumpectomy.~   "
45028|NCT02977455|"~     Existing researches show that brain is an organ highly dependent on continuous blood supply.~     Energy and oxygen required for normal physiological activities in the brain are stably~     maintained by a neurovascular regulatory mechanism, also known as functional congestion.~     While under pathological condition such as ischemia, this regulatory mechanism would be~     impaired and brain function loss and tissue damage occur. During anesthesia in cardiac~     surgery, inevitable circulatory fluctuations could result in decreasing blood pressure and~     cerebral blood flow and therefore brain tissue is in ischemia. In this situation the~     neurovascular regulatory mechanism will function and the brain oxygen saturation also changes~     based on how this mechanism is influenced. the investigators were devoted to observe how this~     mechanism was influenced during surgery and how the neural function recovers after surgery so~     to explore the relationship between them.~   "
45029|NCT02977442|"~     Insulin promotes the clearance of sugars from the blood into skeletal muscle and fat cells~     for use as energy; it also promotes storage of excess nutrients as fat. Type 2 diabetes~     occurs when the cells of the body become resistant to the effects of insulin, and this causes~     high blood sugar and contributes to a build-up of fat in muscle, pancreas, liver, and the~     heart. Understanding how insulin resistance occurs will pave the way for new therapies aimed~     at preventing and treating type 2 diabetes.~      Mitochondria are cellular structures that are responsible for turning nutrients from food,~     into the energy that our cells run on. As a result, mitochondria are known as the powerhouse~     of the cell. Mitochondria are dynamic organelles that can move within a cell to the areas~     where they are needed, and can fuse together to form large, string-like, tubular networks or~     divide into small spherical structures. The name of this process is mitochondrial dynamics~     and the process keeps the cells healthy. However, when more food is consumed compared to the~     amount of energy burned, mitochondria may become overloaded and dysfunctional resulting in a~     leak of partially metabolized nutrients that can interfere with the ability of insulin to~     communicate within the cell. This may be a way for the cells to prevent further uptake of~     nutrients until the current supply has been exhausted. However, long term overload of the~     mitochondria may cause blood sugar levels to rise and lead to the development of type 2~     diabetes.~      This study will provide information about the relationship between mitochondrial dynamics,~     insulin resistance and type 2 diabetes.~   "
45030|NCT02977429|"~     This research will confirm that Pcv-aCO2 is suitable for the guidance of early fluid therapy~     and the evaluation of the prognosis of patients with abnormal hemodynamics after abdominal~     tumor surgery, and is expected to be a new monitoring index to improve the therapeutic effect~     of these patients.~   "
45031|NCT02977416|"~     During exercise, energy comes mainly from carbohydrates and lipids. The relative contribution~     of lipids and glucose as energy substrates to exercise depends on the parameters of the~     exercise (duration, intensity and level of training) and the physiological conditions of the~     subject.~      Inflammatory diseases such as juvenile idiopathic arthritis (JIA) are treated, for the most~     severe forms, by biotherapies. These treatments target certain pro-inflammatory cytokines~     including TNFα. In adults with rheumatoid arthritis several studies have shown that treatment~     with anti-TNFα increases insulin sensitivity. There is no data on the oxidation of energy~     substrates during exercise in children and adolescents with AJI, nor on the impact of~     anti-TNFα treatments on the oxidation of energetic substrates in children.~      Investigators hypothesize that, compared to healthy children, children with JIA should~     exhibit altered oxidation of energy substrates at rest and submaximal physical exercise due~     to physical deconditioning and inflammation. In addition, those treated with anti-TNFα should~     have an oxidation profile of energy substrates at exercise different from that of patients~     not treated with anti-TNFα. Investigators also hypothesize that anti-TNFα treatments modify~     the contribution of energy chains (aerobic, anaerobic and anaerobic alactic) during the~     exercise.~   "
45044|NCT02977247|"~     The SoftVue™ is a whole breast ultrasound system with an automated scanning curvilinear~     ring‐array transducer that employs UST. It is currently cleared under FDA 510(k) K123209 and~     K142517 for use as both a B‐mode ultrasonic breast imaging system and color imaging of~     transmission data (sound speed and attenuation). SoftVue™ is not intended to be used as a~     replacement for screening mammography.~      SoftVue uses non‐ionizing ultrasound energy to generate tomographic image volumes of the~     whole breast. While the patient lays prone on a padded table with one breast comfortably~     submerged in a bath of warm water, a ring‐shaped transducer, 22 cm in diameter, encircles the~     breast and pulses low‐frequency sound waves through the water and into the breast tissue.~     More than 2000 elements in the curvilinear transducer's 360 degree array emit and receive~     ultrasound signals to analyze echoes from the breast anatomy in all directions, from the~     chest wall to the nipple. Not only does SoftVue capture data from the reflection of the sound~     waves off of tissue boundaries and structures within the breast, but because the transducer~     surrounds the whole breast, SoftVue also captures signals that are transmitted through the~     breast. This additional transmission data enhances the visualization of the anatomic~     structure of the breast tissue and is not currently available in any other commercially~     marketed breast ultrasound device.~      This prospective, multicenter, multi‐arm, clinical case collection program is IRB‐approved~     and will be conducted in compliance with Good Clinical Practice, the Declaration of Helsinki~     and all applicable regulatory requirements. Arm 2 aims to collectively enroll up to 1,000~     women at a total of up to 8 clinical sites. The design of Arm 2 in this protocol is strictly~     limited to case collection and is non-interventional; any investigational and/or statistical~     plans for future analyses will be prepared and registered separately, if they are applicable~     to the requirements of FDAAA 801.~      Arm 2 is limited to the cohort of diagnostic female patients of any breast density~     composition category, who have been recommended for a breast biopsy (BI-RADS 4 or 5) after~     diagnostic imaging, or who have confirmed imaging findings. Matched sets of diagnostic~     imaging and SV exams, from the same patient, demographic information, and clinical outcome~     data, will be collected during diagnostic workup. Ultrasound characteristics for all types of~     lesions, whether they are benign or malignant, will be collected as well as objective and~     subjective breast density composition data. Ultrasound image data may be acquired with~     modified SoftVue devices, which have passed safety and quality evaluations per Delphinus'~     quality management system (QMS) and satisfy design change control standards, at select~     clinical sites in accordance with 21 CFR 812.2 (b), as a routine part of feasibility,~     validation, and verification testing for engineering and product development purposes.~      The exams and clinical data accumulated in this prospective case collection (PCC) protocol~     will populate a database from which future investigations may be designed for peer reviewed~     publication, development of user training curricula, building teaching case, and creating new~     marketing materials for SoftVue.~   "
45045|NCT02977234|"~     The purpose of this study is to assess the effectiveness of hysteroscopic tubal application~     of Iso Amyl-2-cyanoacrylate in occluding uterine tubes of infertile women with hydrosalpinx,~     which would make it an easy approach for occluding tubes with hydrosalpinx prior to IVF.~   "
45032|NCT02977403|"~     Background:~      People are constantly exposed to unhealthy foods. Some studies of adults show that training~     attention away from unhealthy foods might reduce overeating. Researchers want to see what~     happens in the brain when teens train their attention away from food through a program on a~     smartphone.~      Objective:~      To study the relationship between eating patterns, body weight, and how the brain reacts to~     different images.~      Eligibility:~      Right-handed females ages 12-17 who are overweight (Body Mass Index at or above the 85th~     percentile for age).~      Design:~      Participants will have 6 visits over about 8 months.~      Visit 1: participants will be screened with:~      Height, weight, blood pressure, and waist size measurements~      Medical history~      Physical exam~      Urine sample~      DXA scan. Participants will lie on a table while a very small dose of x-rays passes through~     the body.~      Questions about their general health, social and psychological functioning, and eating habits~      Parents or guardians of minor participants will answer questions about their child s~     functioning and demographic data.~      Before visits 2-6, participants will not eat or drink for about 12 hours. These visits will~     include some or all of these procedures:~      Blood drawn~      MRI scan. Participants will lie on a stretcher that slides in and out of a metal cylinder in~     a strong magnetic field. A device will be placed over the head.~      Meals provided. Participants will fill out rating forms.~      Simple thinking tasks~      A cone containing magnetic field detectors placed onto the head~      Medical history~      Physical exam~      Urine sample~      Participants will be assigned to a 2-week smartphone program that involves looking at~     pictures. Participants will complete short tasks and answer some questions about their eating~     habits and mood on the smartphone.~   "
45033|NCT02977390|"~     This is a pilot study to investigate whether patients at advanced age are fluid responders~     via a reversible fluid challenge, the passive leg raise test. This will be measured with a~     non-invasive cardiac output monitor, the LiDCO (LiDCO Hemodynamic monitoring) .~   "
45034|NCT02977377|"~     To investigate the effects of whole body vibration on postural control and on the level of~     satisfaction regarding how to reach the goals of the patients with ataxia~   "
45035|NCT02977364|"~     To investigate safety, tolerability and pharmacokinetics of C-met Kinase Inhibitor HS-10241~     in Subjects With Advanced Solid Tumours that are not eligible for conventional or intensive~     treatment. The dose of HS-10241 will be escalated to determine the dose limiting toxicity~     (DLT) and the maximum tolerated dose (MTD) of HS-10241 in advanced cancer patients. At the~     same time, pharmacokinetic characteristics and preliminary efficacy of HS-10241 will be~     observed in advanced cancer patients. To determine the recommended dosage regimen for phase~     II.~   "
45036|NCT02977351|"~     Determine the relationship between the systemic indications of atherosclerosis by means of~     the change in the ratio of periodontopathogenic microorganisms following periodontal~     treatment of individuals who have been diagnosed with chronic periodontitis-atherosclerosis~     and for individuals who have been diagnosed with systemically healthy-chronic periodontitis.~   "
45037|NCT02977338|"~     Drug induced sleep endoscopy (DISE) is an increasingly performed procedure, offering dynamic~     upper airway evaluation during artificial sleep before surgical treatment for patients with~     obstructed sleep apnea (OSA).~      DISE is a safe procedure, easily practicable, valid and reliable. The investigators consider~     it a fundamental clinical procedure that is essential before choosing the surgical treatment.~     The investigator's results so far suggest that a multilevel collapse is significantly~     associated with higher apnea hypopnea index values. The investigators think that the weight~     did not play a significant role in RDI reduction. Results till now show that tailored surgery~     based on DISE may leverage sleep surgeries outcome significantly, presenting 70% success rate~     based on the investigator's experience The aim of this study is to evaluate surgery results~     in patients who underwent DISE prior to their surgery in comparison to their condition prior~     to the treatment.~   "
45038|NCT02977325|"~     Questionnaires are often irreplaceable tools of collection of information in research and in~     the clinical practice. Coupled with other measures, they can be simple complementary tools,~     but questionnaires are sometimes the only way to collect data, such as self-service efficacy.~      The objective of this study is a validation of the French translation of the ASES. To~     guarantee the comparability between the original version and the translated version, the~     translation of a questionnaire supposes two essential stages: a literal translation and an~     adaptation to the cultural context, to the habits of life and to the idioms of the target~     population. This new version will afterward be validated with patient's troop.~   "
45039|NCT02977312|"~     This study assessed the efficacy and safety of generic imatinib in patients with chronic~     myeloid leukemia (CML) in Jordan. It was a multicenter, non-interventional, open-label,~     prospective study combined with retrospective data collection from files of patients with a~     diagnosis of Ph+ CML, treated with Cemivil (imatinib), where no visits or intervention(s)~     additional to the daily practice were performed~   "
45040|NCT02977299|"~     This is a multi-site, randomized, open-label, effectiveness trial comparing three treatment~     arms for Major Depressive Disorder (MDD) patients with TRD who are currently on ongoing,~     stable and adequate antidepressant therapy (ADT). Adequate ADT is defined as a~     therapeutically sufficient dose for a sufficient treatment period, which would be expected to~     be effective as listed in the MGH Antidepressant Treatment Response Questionnaire (ATRQ).~     Patients will be randomized in a 1:1:1 fashion to one of three open-label treatment arms: a)~     aripiprazole augmentation, b) rTMS augmentation, and c) switching to venlafaxine XR or~     Duloxetine.~   "
45041|NCT02977286|"~     This study evaluates the addition of naloxegol (Movantik) to a laxative protocol in~     critically ill adults requiring scheduled opioid (e.g. fentanyl) therapy. Half of the~     participants will receive naloxegol and a laxative protocol and half the participants will~     receive a placebo and a laxative protocol.~   "
45042|NCT02977273|"~     Meal size is strongly influenced by a number of external features of the food environment~     which can promote over-consumption, such as the availability of palatable energy dense foods~     and large portion sizes. The current research aimed to investigate whether natural food-based~     differences in texture could be used to slow down eating rate and reduce intake from large~     portions.~      A four-session randomised crossover study assessed the effect of faster vs. slower eating~     rate, achieved through manipulating food texture, on ad-libitum consumption (weight and~     calories) of a meal, alone and in combination with variations in meal portion size (regular~     vs. large)~   "
45043|NCT02977260|"~     Meal size is strongly influenced by a number of external features of the food environment~     which can promote over-consumption, such as the availability of palatable energy dense foods.~     The current research aimed to investigate whether natural food-based differences in texture~     could be used to slow down eating rate and reduce intake from large portions and higher~     energy dense foods.~      A four-session randomised crossover study assessed the effect of faster vs. slower eating~     rate, achieved through manipulating food texture, on ad-libitum consumption (weight and~     calories) at a meal, alone and in combination with variations in meal energy-density (higher~     vs. lower)~   "
45046|NCT02977221|"~     Applying flapless piezocision corticotomies on the alveolar bone and separating anterior~     mandibular teeth using a piezosurgery device (i.e. ultrasonic waves that perform very~     accurate incisions without any sutures following this procedure) may improve the speed of~     tooth alignment during orthodontic treatment. This study consists of two groups, patients~     will be randomly assigned to one of these two groups. The efficacy of this procedure on 18~     patients (experimental group) will be evaluated,whereas the second group (control group) will~     receive a traditional orthodontic therapy. The time required to achieve complete alignment of~     crowded mandibular anterior teeth (from canine to canine) will be compared between the two~     groups.~   "
45047|NCT02977208|"~     This study aims to evaluate the influence of genetic polymorphisms of OCTN1 and OCT2 and~     other possible covariates on the kinetic disposition of GAB in patients undergoing GAB~     chronic treatment. Thus, patients treated with GAB, for at least one week, are being~     investigated.~   "
45048|NCT02977195|"~     For most advanced solid tumors, current therapy is inadequate at improving quality of life,~     slowing progression of disease, prolonging survival, and providing a cure. Hence, there is a~     continuous need for innovative, safer and more effective anti-cancer therapies. Our study is~     based on the dependence receptor paradigm and the associated therapeutic strategy. In~     preclinical models, preventing Netrin-1 interaction with its receptors is sufficient to~     trigger Netrin-1-expressing tumor cell death in vitro as well as tumor growth and metastasis~     inhibition in vivo. This indicates that a therapeutic approach based on Netrin-1/Netrin-1~     receptors interaction inhibition is both feasible and promising. NP137 is a first-in-class~     humanized monoclonal antibody targeting the Netrin-1 ligand, a secreted protein recently~     described as a driver of tumor initiation and progression. NP137 demonstrated anti-tumor~     activity as a single agent in several pre-clinical models of cancer, including breast and~     lung cancer. Taken together, several studies strongly support the rational for preclinical~     development and clinical evaluation of a highly potent and selective anti-Netrin-1 antibody~     in cancer patients. The proposed study is an open label, multicenter, Phase I dose escalation~     study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and~     preliminary anti-tumor activity of NP137 administered every 2 weeks (Q2W) as single agent in~     patients with locally advanced or metastatic solid tumors. This trial will be the First in~     Human (FIH) study for NP137; there is no clinical experience with this antibody in the~     clinic. The study consists of 2 parts: Part 1) a dose escalation part to define the Maximum~     tolerated dose and the Recommended Phase II dose (MTD /RP2D) of NP137 as well as to research~     some PD biomarkers (Biological collection cohorts) an expansion part to assess the PD and~     anti-tumor activity of NP137.~   "
45049|NCT02977182|"~     Injuries to the face caused by traumatic events such as motor vehicle collisions, assault,~     and falls can result in facial trauma, which can result in swelling and disfiguration that~     impairs the important functions of the face, sometimes to a life threatening degree. These~     injures and the resultant swelling can also precipitate psychological and social~     consequences.~      Lymphedema is an abnormal amount of fluid that causes swelling, usually in the arms or legs.~     The most common presentation of lymphedema is in the upper extremities due to breast cancer~     treatment (Maclellean RA et al). As such, standards of care for management of lymphedema are~     primarily derived from the cancer research literature and involve the extremities (Moffatt~     CJ. 2003 QJM). The current gold standard treatment for patients with extremity lymphedema is~     complete decongestive therapy (CDT) (Zuther 2013). CDT is a multimodal therapy consisting of~     four components: manual lymph drainage, compression wrapping, exercise, and skin care (Zuther~     2013).These same therapeutic techniques of CDT have been employed at Our Lady of the Lake~     Regional Medical Center (OLOLRMC) and adapted to treat patients with facial trauma with~     anecdotally good results primarily related to cosmesis. To the best of our knowledge, no~     clinical studies examining the effect of lymphedema treatment in the management of blunt~     facial trauma currently exist.. Beyond the consideration of cosmesis, we also seek to~     determine if this intervention improves clinical outcomes such as time to swallowing and~     reduced time utilizing mechanical ventilation. This study will prospectively evaluate the use~     of complete decongestive therapy to test the hypothesis that this intervention results in~     improved clinical outcomes in patients with blunt facial trauma.~   "
45050|NCT02977169|"~     Rationale: Completely resected non-small cell lung cancer (NSCLC) patients with~     histologically confirmed N2 disease are a heterogeneous population, with 5-year survival~     rates ranging from 10% to 30%. Systemic recurrence following surgery is one of the major~     problems in stage IIIA(N2) patients, and the use of postoperative chemotherapy (POCT) in~     stage IIIA disease prolongs survival. The value of postoperative radiotherapy (PORT) for~     completely resected NSCLC remains controversial, as the effect on survival has been~     inconclusive. Recently, several large retrospective studies and reviews of the National~     Cancer Database indicated that modern PORT appears to confer an additional 5% survival~     advantage beyond that achieved with adjuvant chemotherapy alone. Actually, after complete~     resection and POCT, 20%-40% of cases have a risk of locoregional recurrence (LRR). Patients~     with completely resected stage IIIA(N2) disease might hold different postoperative~     patterns-of-failure and prognosis. It is not yet known for subsets with specific prognostic~     factors that confer lower LRR risks, whether giving PORT is more effective than no radiation~     therapy in treating patients with completely resected pathologic stage IIIA(N2) NSCLC.~      Purpose: This randomized phase II trial is studying the clinical efficacy of PORT~     administered using three-dimensional conformal radiotherapy (3D-CRT) techniques and the~     proposed standard PORT clinical target volume (CTV) delineation guideline in treating low~     risk of LRR patients with completely resected pathologic stage IIIA(N2) NSCLC.~   "
45051|NCT02977156|"~     The success of anti-CTLA4 therapy has inaugurated a paradigm shift in oncology where drugs~     target the immune system rather than cancer cells in order to stimulate the anti-tumor immune~     response. In situ immunization is a strategy where immunomodulatory products such as~     pathogens are injected into one tumor site in order to trigger a systemic anti-tumor immune~     response. Of importance, pre-clinical rationale has demonstrated that combination of~     anti-CTLA4 therapy together with intra-tumoral (IT) oncolytic virus can overcome primary~     resistance to systemic anti-CTLA4 therapy. Pexastimogene Devacirepvec (Pexa-Vec) is one of~     the new vaccinia oncolytic viruses genetically modified to express GM-CSF. This new and~     innovative oncolytic virotherapy should therefore synergize with anti-CTLA4 therapy via~     virus-induced tumor cell death & tumor-antigen release, GM-CSF-induced~     recruitment/maturation/activation of antigen presenting cells, and anti-CTLA4-induced Treg~     blockade/depletion. Intra-tumoral delivery of immunostimulating agents should, therefore,~     provide lower toxicity of mAb targeting immune checkpoints. Of note, IT injections of~     GM-CSF-encoding oncolytic viruses have already been shown to induce immune-mediated tumor~     responses on local (injected) and distant (not injected) tumor sites. In solid injectable~     refractory/relapsing metastatic tumors, we make the hypothesis that the addition of Pexa-Vec~     to IT ipilimumab (anti-CTLA4 Ab) will overcome primary/secondary resistance to standard~     therapy and/or immunotherapy with a better in situ tumor antigen specific T-cell priming. Our~     proposal is to conduct a 2-part Phase I clinical trial in order to define the feasibility,~     the safety and the anti-tumor effects of intra-tumoral injections of ipilimumab in~     combination with the oncolytic virus Pexa-Vec. Dose escalation step will define the MTD and~     RP2D of that in situ immunization strategy. Expansion part will assess the anti-tumor effect~     of the combination.~   "
45078|NCT02976805|"~     This is a multi-centre randomized clinical trial comparing the efficacy of two different~     bowel preparation regimens for patients who have already failed a bowel preparation for~     colonoscopy.~   "
45053|NCT02977130|"~     The American Diabetes Association indicates that diabetes self-management is a skill that~     diabetic patients must learn in the Diabetes Self-Management Education; thus, this~     contributes to shared care for diabetes, in which teams of physicians, professional nurses,~     and dietitians offer shared care to patients. However, according to the statistical analysis~     of the conditions of glycemic control in diabetic patients in 28 countries across 4~     continents (Asia, Africa, Europe, and South America), the mean glycated hemoglobin (HbA1c) of~     the 12,727 patients was 9.5% by Litwak et al. in 2013. In Taiwan, a national survey among~     diabetic patients in a shared-care program found that the percentage of patients with HbA1c~     lower than 7% increased by 6.5% from 2006 to 2011; yet, among the 720 patients who completed~     both surveys in 2006 and 2011, the percentage with HbA1c lower than 7% decreased by 2.1%~     during that period. These results suggest that despite the increase in the proportion of~     patients who successfully managed their diabetes, some patients still encountered difficulty~     in glycemic control.Therefore, numerous health education tools on diabetes continue to be~     developed. In 2011,JoAnn et al. determined that the mode of health care had a substantial~     influence on the dietary habits of diabetic patients, and that individual health education~     had the largest effect on diabetes control. In addition, using the conversation map for~     diabetes control also had a substantial influence on improving health behaviors. Among~     existing studies that have adopted the conversation map, no large-scale research has been~     conducted, the research samples and relevant studies in Taiwan have been scant, and no~     theoretical foundation has been applied in evaluating the effects of the conversation map.~     Accordingly, the investigators aimed to enhance the mutual experience exchange and learning~     among diabetic patients through adopting the conversation map to observe its influence on~     their health behaviors by incorporating it into existing health education modalities.~     Furthermore, on the basis of the Health Belief Model, a relevant questionnaire was designed~     for assessing the effectiveness of glycemic control in diabetic patients.~   "
45054|NCT02977117|"~     The purpose of this trial is to examine the effect of increasing dialyse magnesium on serum~     calcification propensity in subjects with end-stage renal disease treated with haemodialysis.~   "
45055|NCT02977104|"~     The purpose of this study is to demonstrate that the Maestro hand held heart monitor can~     accurately diagnose Atrial Fibrillation, atrial flutter or normal sinus rhythm in patients.~   "
45056|NCT02977091|"~     fitness and Physical activity will be evaluate in short stature children, using the Euro~     Fitness testing and the Wingate anaerobic test. the fitness level will be evaluate in healthy~     short children and with growth hormone deficiency at base line and after 6 month .~   "
45057|NCT02977078|"~     This study will use inhaler technology to observe and feedback overall patterns of medication~     use. We will look at whether this improves preventer inhaler use and reduces reliever inhaler~     overuse.~      We will also assess whether inhaler technology is patient-friendly and cost effective,~     whether it helps with treatment decisions in asthma and whether it can help us to predict and~     prevent asthma attacks.~   "
45058|NCT02977065|"~     A multicenter, double-blind, parallel-group, active-controlled, dose-ranging study to assess~     the safety and efficacy of the novel cholesteryl ester transfer protein (CETP) inhibitor~     CKD-519 in combination with atorvastatin or rosuvastatin in subjects with dyslipidemia.~   "
45059|NCT02977052|"~     This is an open-label three-arm phase 2 trial (including a Simon stage 2 design) consisting~     of 90 stage III melanoma patients randomized 1:1:1 to receive either 2 courses 3 mg/kg~     ipilimumab + 1 mg/kg nivolumab every 3 weeks (Arm A), 2 courses 1 mg/kg ipilimumab + 3 mg/kg~     nivolumab every 3 weeks (Arm B), or 2 courses ipilimumab 3 mg/kg, directly followed by 2~     courses nivolumab 3 mg/kg every 2 weeks (Arm C). All three treatment arms are applied prior~     to surgery at week 6, 30 patients per arm. Patients will be stratified according to treatment~     center. An interim analysis will be performed after 13 patients have been included in each~     arm, thus in total 39 patients have been included.~   "
45060|NCT02977039|"~     The purpose of this study is to evaluate the effect of a nutrient dense plant rich (NDPR)~     diet compared to a standard USDA diet on glycemic control, inflammation, and cardiovascular~     risk in individuals with type 2 diabetes and overweight/obesity.~   "
45061|NCT02977026|"~     Alcohol is one of the leading contributors to premature mortality and disability. Most people~     with alcohol problems will never seek treatment. There is a need to develop alternate ways to~     help problem drinkers outside of formal treatment settings.~      One promising strategy is Internet-based interventions for problem drinkers. Our recently~     completed RCT comparing a brief (Check Your Drinking; CYD) versus an extended (Alcohol Help~     Centre; AHC) Internet intervention for problem drinkers found that, while there was a~     reduction in drinking across time for both interventions, there was no significant (p > .05)~     difference in reductions in drinking between the two interventions. Based on these results,~     it is not justifiable to say that either intervention 'worked' as there was no comparison~     condition of participants who received no active intervention. The current trial proposes to~     address this limitation by conducting an RCT comparing the CYD, AHC, and a no intervention~     control condition.~      Participants will be recruited through Amazon's MTurk crowdsourcing platform. Participants~     identified as problem drinkers based on an initial survey will be invited to complete another~     survey in 6 months time. Those who are interested will be randomized to receive access to the~     Check Your Drinking screener (CYD condition), Alcohol Help Centre (AHC condition) or a~     feedback questionnaire (control condition). At six-months post-baseline, the MTurk portal~     will be used to send invitation emails that contain a link to the follow-up survey. The~     primary hypothesis to be tested is that participants receiving access to the AHC intervention~     will report a greater reduction in AUDIT-C scores and in number of drinks in a typical week~     than participants in the CYD intervention. Further, participants in the CYD condition will~     report a greater level of reduction AUDIT-C scores and in number of drinks in a typical week~     between the baseline survey and six-month follow-up as compared to participants in the no~     intervention control condition.~   "
45062|NCT02977013|"~     The aim of the present study is to monitor anticoagulant therapy by anti-Xa assay and~     correlate its level to the efficacy and safety of enoxaparin in the treatment of pulmonary~     embolism.~   "
45063|NCT02977000|"~     Retinopathy of prematurity (ROP) is a major cause of blindness and visual impairment in~     children in both developing and developed countries around the world. ROP is a multifactorial~     disease characterized by perturbation of normal vascular development in the retina. The~     pathogenesis of ROP is hypothesized to consist of two distinct phases of which the second~     phase is characterized by hypoxia-induced up-regulation of vascular endothelial growth factor~     (VEGF) and retinal neovascularization.~      Recent studies have shown a relationship between the β-adrenergic system and angiogenesis.~     This relationship has been observed in several diseases, like infantile hemangiomas, ROP, and~     neoplasias. Studies in animal models have shown that norepinephrine stimulates VEGF~     expression and secretion in retinal cells. In oxygen induced retinopathy, blockage of~     β-adrenergic receptors (β-AR) can inhibit the angiogenic cascade and interfere with further~     proliferation of retinal vasculature. Also, angiogenesis seems to be impaired in β-Argene~     deficient mice, when exposed to hypoxia and other stimuli, but this function is restored~     after gene therapy.~      Assuming in human preterm newborns with ROP that VEGF overexpression and retinal~     neovascularization in response to hypoxia might involve b-AR activation, we design~     prospective randomized study to assess the effect of oral propranolol on the progression of~     early stages of ROP in very low birth weight infants.~   "
45093|NCT02976610|"~     This study aims to investigate the outcome of hemolysis frequency when a hemolysis point of~     care test is introduced in an emergency department.~   "
45188|NCT02975375|"~     The investigators will conduct a population-based study using health administrative data to~     evaluate the impact of preoperative geriatric consultation on postoperative outcomes in older~     patients having elective, non-cardiac surgery~   "
45064|NCT02976987|"~     The infections of high grade induced by the human papilloma viruses cause precancerous~     lesions of the cervical epithelium. The progression of these lesions can lead to the onset of~     cervical cancer. To reduce the risk of cancer lesions classified as 'cervical squamous~     intraepithelial neoplasia 2' (CIN2) and 'cervical squamous intraepithelial neoplasia 3'~     (CIN3), the standard treatment is the conisation of the cervix. This surgery can lead to~     complications such as infertility or a risk of preterm birth, hence the need to move towards~     a non-surgical alternative therapy.~      The colvir clinical trial was a phase-II, multi center, randomized, double blind, efficacy~     study of an aqueous gel containing 2% (w/w) cidofovir, administrated directly on cervix~     exhibiting high grade squamous intraepithelial lesion (CIN 2 and 3).~      This clinical trial is a prolongation of the colvir trial, in order to~        -  assess the long term histological and virological evolution (24 months) of 3 g of 2%~          (w/w) cidofovir gel, administrated directly on cervix exhibiting high grade~          intraepithelial neoplasia after complete response, partial response or response failure~          at the end of the Colvir study.~        -  assess the long term (24 months) rate of recurrence of histological lesions of the~          Colvir patients after conisation, in both placebo and treatment groups.~   "
45065|NCT02976974|"~     The efficacy of manual therapy and therapeutic exercise in patients suffering from adhesive~     capsulitis of the shoulder will be studied. Furthermore, different biomechanic and~     psychosocial factors will be measured with a nine month follow-up~   "
45066|NCT02976961|"~     This study evaluates the clinical efficacy and cost-effectiveness of the ACQUIRE-ICD care~     innovation as add-on to usual care as compared to usual care alone in patients with an~     implantable cardioverter defibrillator.~   "
45067|NCT02976948|"~     Main objective: To compare the efficacy of a new strategy of Next Generation Sequencing (NGS)~     versus a classical Sanger strategy, for the diagnosis of patients referred to the laboratory~     for suspected systemic autoinflammatory diseases (SAID).~      Secondary objectives:~        -  Compare after 6 months the impact of these strategies on the establishment of an~          effective treatment SAID following genetic result.~        -  Compare the distribution of different forms of SAID found with each genetic diagnostic~          strategies (NGS vs classic method).~   "
45068|NCT02976935|"~     The aim of this study is to investigate the potential value of a novel imaging technique~     (hyperpolarized 129Xe lung imaging) in the diagnosis and assessment of lung disease in~     patients with COPD and IPF.~   "
45069|NCT02976922|"~     Recurrent aphthous stomatitis (RAS) is one of the most common ulcerative diseases affecting~     the oral mucosa. The aetiology remains unknown, but several local, systemic, immunologic,~     genetic, allergic, nutritional, and microbial factors have been proposed as causative agents.~     Clinically, RAS is characterised by recurrent bouts of one or several rounded, shallow,~     painful oral ulcers at intervals of a few months or days. The aim of this study is to~     characterise the salivary and faecal microbiome in 20 patients with RAS and compare the~     findings with those of 20 healthy controls. The study also includes a double-blind randomized~     placebo-controlled intervention with probiotics (Lactobacillus reuteri-containing lozenges 2~     tablets daily for 3 months) or placebo. The salivary and faecal microbiome in RAS patients is~     compared before and after treatment. This study will improve our understanding of the~     pathogenesis in RAS and provide us with knowledge on potential future therapeutic approaches.~   "
45070|NCT02976909|"~     Paclitaxel In combination with DDP and 5-FU(TPF) as neoadjuvant chemotherapy in treating~     boundary resectable locally advanced esophageal squamous cell carcinoma: A phase II clinical~     trial.~   "
45071|NCT02976896|"~     We conduct the phase II clinical trial to further explore the efficacy and safety of Apatinib~     Mesylate in treating recurrent or metastatic esophageal squamous cell carcinoma after the~     failure of conventional treatments. An exploratory molecular marker analysis will be~     performed in order to find out the beneficial population of Apatinib Mesylate.~   "
45072|NCT02976883|"~     The aim of this study is to investigate the radiotracer [18F]HX4 for non-invasive detection~     of hypoxia in patients with head and neck, or lung cancer. Each participant will undergo a~     diagnostic [18F]HX4 PET/CT scan before beginning radiotherapy treatment. Patient follow up~     data will be collected from routine appointments, and analysed with the hypoxia scan results~     to assess whether [18F]HX4 PET/CT scanning can predict patient outcome from radiotherapy~     treatment.~   "
45073|NCT02976870|"~     Anterior lumbar spinal surgery involves making an incision through the abdomen of the patient~     in order to access the spine. During this process, several internal structures are pushed~     aside in order to gain access. One of these structures is the ureter, whose function is to~     drain urine from the kidney to the bladder. One potential complication that can arise from~     this is dilation of the kidney - known as hydronephrosis. The aim of this study is to~     identify whether hydronephrosis after Anterior Lumbar Interbody Fusion (ALIF) is~     complication, in order to bring this to the attention of health care professionals when~     considering this kind of surgery.~   "
45074|NCT02976857|"~     The trial is a single arm, single-center, non-randomized phase I clinical trial which is~     designed to evaluate the safety and efficacy of C-CAR011 in treatment of refractory DLBCL~   "
45075|NCT02976844|"~     Esophageal pressure (PES), which has been used as a surrogate for pleural pressure. The~     volume of esophageal balloon can influence the accuracy of monitoring esophageal pressure.~     The optimal balloon volume is directly dependent on surrounding pressure. In the present~     study,the investigators will observe the optimal volume of esophageal balloon during the~     different PEEP in bench and clinical study.~   "
45076|NCT02976831|"~     Plaque psoriasis vulgaris is a chronic inflammatory skin disorder, affecting 1-3% of the~     population in Europe and the United States of America (USA) and represents one of the most~     prevalent immune inflammatory diseases. AZD0284 is a potent selective inverse agonist of~     RORg, which is being developed for the management of psoriasis. The current Phase 1 study~     investigates the safety, tolerability, food effect, pharmacokinetic (PK) and pharmacodynamic~     (PD) properties of single and repeated doses of AZD0284. The study will be conducted in~     healthy subjects. The study will be divided into 2 parts: Part 1 (SAD) and Part 2 (MAD), with~     Part 1 being split into 2 sub-parts: 1A (fasting) and 1B (fed). The results from this study~     will form the basis for decisions on future studies. The study will help to identify~     appropriate, well-tolerated doses that can be administered in subsequent studies in patients~     with psoriasis.~   "
45077|NCT02976818|"~     Aortic valve stenosis (AVS), the most common form of valve disease in the western world,~     afflicts more than 1 million individuals in North America [1] and the burden of AVS is high~     and is expected to double within the next 50 years [2]. Medical therapy to prevent~     development or reduce progression of AVS is currently not available and the only effective~     treatment for AVS is aortic valve replacement, for which costs have been estimated up to~     120,000$ [3,4]. Recently, we and others have identified rs10455872 at the LPA locus as a~     susceptibility single nucleotide polymorphism (SNP) for aortic valve calcification (AVC) and~     AVS [5,6] and rs10455872 is associated with elevated plasma lipoprotein (Lp)(a) levels [7].~     Lp(a) is a LDL-like particle consisting of hepatically synthesized apolipoprotein B-100 that~     is noncovalently bound to the plasminogen-like glycoprotein apolipoprotein(a) [8]. Lp(a)~     promotes atherosclerotic stenosis, and possibly thrombosis, and has been hypothesized to~     contribute to wound healing, each of which could explain an association with AVS [9,10].~     Lp(a) is relatively refractory to both lifestyle and drug intervention, with only nicotinic~     acid and monoclonal antibody inhibition of the proprotein convertase subtilisin/kexin type 9~     that have showed reductions in Lp(a) levels [11,12]. However, the evidence that patients with~     AVS could be characterized by high Lp(a) levels is scarce. Glader et al. [13] showed that~     plasma levels of Lp(a) were almost 1.5-fold higher in 101 patients with AVS compared to~     matched controls, although this relationship did not reach statistical significance.~     Subsequent studies have also reported an association between elevated plasma Lp(a) levels and~     higher prevalence of AVS. More specifically, Kamstrup and colleagues [14] reported that~     elevated Lp(a) levels and corresponding genotypes were associated with increased risk of AVS~     in the general population with levels >90 mg/dL predicting a threefold increased risk. We~     have measured Lp(a) and oxidized phospholipids plasma levels in 220 patients with~     mild-to-moderate calcific AVS enrolled in the Aortic Stenosis Progression Observation:~     Measuring Effects of Rosuvastatin (ASTRONOMER) trial [15]. Results of this study suggest that~     high Lp(a) and oxidized phospholipids both predict calcific AVS progression, especially in~     younger patients with calcific AVS. We also found that statin therapy considerably increased~     both Lp(a) and oxidized phospholipids levels. Whether the fact that statins increase these~     risk factors for calcific AVS might explain at least to a certain extent why statins failed~     to promote calcific AVS regression or stabilization in at least four trials, including~     ASTRONOMER.~      Familial hypercholesterolemia (FH) is an autosomal codominant single-gene disorder caused by~     mutations in the LDL receptor gene that disrupt normal clearance of LDL. Phenotypic features~     characteristic of the disease's heterozygous form are 2- to 3-fold raise in plasma~     LDL-cholesterol concentrations, tendinous xanthomatosis and premature atherosclerotic~     coronary artery disease. High Lp(a) levels have been shown to explain residual cardiovascular~     disease risk in FH [16,17]. Recent studies have demonstrated that FH heterozygotes have~     elevated AVC compared with non-FH subjects [18] and that Lp(a) levels were positively~     correlated with AVC in asymptomatic FH heterozygotes [19]. Vongpromek et al. [19]~     demonstrated that plasma Lp(a) concentration is a independent risk factor for AVC in a cohort~     of 129 asymptomatic heterozygous FH patients aged between 40 and 69 years. In this study, AVC~     was significantly associated with plasma Lp(a) level, age, body mass index, blood pressure,~     duration of statin use, cholesterol-year score and coronary artery calcification (CAC) score.~   "
45079|NCT02976792|"~     Postoperative acute renal failure is a frequent complication after a Transcatheter Aortic~     Valve Implantation (TAVI). The current practice cannot predict Acute Kidney Injuries (AKI)~     early enough to prevent an organic dysfunction triggering, consequently, cortical tubular~     necrosis.~      Several recent studies in cardiac surgery have shown that sonographic criteria, the Renal~     Resistive Index (IRR), and a urinary biomarker, the NephroCheck™, could predict AKI promptly.~     These markers, sonographic and biologic, have both the advantage to be non-invasive and easy~     to perform. Each marker seems to have sensitivity and specificity to predict AKI promptly~     after cardiac surgery. Therefore, the IRR and the NephroCheck™ test could become essential~     tests to guide clinicians in determining rapidly whether a patient will develop AKI after a~     TAVI procedure. However, so far, no study has tested the NephroCheck™ in patients undergoing~     TAVI.~      Therefore, the aim of this prospective observational study will be first to determine the~     effectiveness of the NephroCheck™ to predict AKI at an early stage after a TAVI procedure.~     The secondary outcome will be to compare the NephroCheck™ with the RRI in predicting at an~     earlier stage than the traditional method an AKI.~   "
45080|NCT02976779|"~     This single center, prospective, double-blind, placebo-controlled, randomized two parts study~     (part I and part II) will assess the safety of topical cream (3% CBD and 3% THC), applied~     twice daily (bid), in healthy subjects, for up to 6 treatment weeks and additional 2~     follow-up weeks.~   "
45081|NCT02976766|"~     The purpose of this study is to determine whether gypenosides are neuroprotective in patients~     with acute optic neuritis.~   "
45082|NCT02976753|"~     The purpose of the study is to evaluate the effectiveness of Elocta compared to conventional~     factor products in the prophylactic treatment of patients with haemophilia A over a 24-month~     prospective period. Data will also be collected for a 12 month retrospective period.~   "
45083|NCT02976740|"~     The purpose of this study is to determine whether stereotactic body radiotherapy (SBRT)~     combined with recombined human granulocyte-macrophage colony stimulating factor(rhGM-CSF) and~     Thymosin Alpha 1 is safe, effective in the treatment of stage IV NSCLC patients who failed in~     second-line chemotherapy.~   "
45084|NCT02976727|"~     Vitamin D(Vit D) is a pro-differentiation agent that enhances the accumulation of~     protoporphyrin IX (PpIX) after MAL(methyl-aminolevulinate) incubation in actinic keratosis~     and may have significant benefit for the treatment of actinic keratosis by ablative~     fractional laser-primed photodynamic therapy (AFL-PDT).~   "
45085|NCT02976714|"~     The general aims of this project are (i) to identify predictive epigenetic biomarkers of lung~     disease severity in Cystic Fibrosis, (ii) to characterize a non-invasive cellular model,~     spontaneous sputum, for the analysis of these epigenetic biomarkers, (iii) to analyze the~     variations in DNA methylation for a same patient over time.~   "
45086|NCT02976701|"~     This is a prospective, randomized, double-blind, double-dummy, and controlled clinical study~     over a total of 4-week therapy with DLBS1033 in the management of STE-ACS after a primary~     PCI. There will be 40 STE-ACS subjects (20 subjects in each group) planned to complete the~     study.~   "
45087|NCT02976688|"~     End-stage renal disease (ESRD) is associated with multiple comorbidities such as~     cardiovascular disease, anemia, mineral and bone disorders, malnutrition, body wasting,~     muscle loss (sarcopenia), neurological problems and infections resulting in a poor survival.~      In the pathogenesis of the uremic syndrome the altered intestinal function seems to be an~     important contributor. While the normal gut microbiota plays a prominent role in the~     maintenance of health and disease prevention, changes of its composition is associated with~     numerous diseases such as obesity, type 2 diabetes, cardiovascular disturbances and~     auto-immune diseases.In ESRD metabolic alterations of uremia results in quantitative and~     qualitative changes of its bacterial flora with an overgrowth of pathobionts (1). Due to~     concomitant disruption of the intestinal barrier function, noxious luminal products are~     translocated in the body's internal milieu (2).The accumulation of these compounds correlates~     with systemic inflammation, protein wasting and accelerated cardiovascular complications in~     hemodialysis patients (3).~      Short-chain fatty acids (SCFA) are produced in the colon and distal small intestine by~     anaerobic bacteria following fermentation of complex carbohydrates.They have been shown to~     exert anti-inflammatory, anti-cancer, antibacterial and antidiabetic effects (4).~     Supplementation of SCFA exerts anti-inflammatory actions both in intestinal epithelial cells~     (5) and in the cardiovascular system (6). They also positively influence auto- immune~     reactions /diseases (7,8).~      In this study we want to investigate in MHD patients whether a treatment with SCFA in form of~     sodium propionate (SP) modulates the systemic inflammation, insulin resistance and~     accumulation of intestinal uremic toxins.~   "
45088|NCT02976675|"~     To evaluate the safety and efficacy of PEG Somatropin Injection in the treatment of children~     with growth hormone deficiency, as well as to study the feasibility of extending the dosing~     intervals (once per two weeks) of PEG Somatropin Injection.~   "
45089|NCT02976662|"~     Investigators aim to investigate the effect of elimination of blastocoelic fluid by creating~     a large hole in the zona pellucida at the cellular junction of the trophectoderm cells~     located far away from the inner cell mass with a laser pulse before vitrification.~   "
45090|NCT02976649|"~     The purpose of this study is to propose a multi-dimensional score to predict those patients~     undergoing bariatric surgeries who will be in need for postoperative ICU admission.~   "
45091|NCT02976636|"~     The purpose of this application is to evaluate whether a pediatric weight control program~     that incorporates comprehensive parenting training with behavioral therapy can increase~     weight loss in children compared to traditional family-based behavioral therapy programs.~     Since certain parenting styles are associated with greater weight loss during interventions~     and appear to enhance the impact of key behavioral strategies, adding parenting training to~     these interventions may increase the overall effectiveness of these programs and increase our~     ability to help children obtain a healthy weight. This project could result in identifying an~     improved method of pediatric obesity treatment that provides additional benefits to the~     growth and development of children via improved self-regulatory behaviors.~   "
45092|NCT02976623|"~     The investigators hypothesized that feedback based on previously developed and validated~     metrics will improve novices' learning of procedural skills.~      The objective of this study was to determine the effect of a structured, objective and~     terminal feedback on novices' performance skills of ultrasonography part of ultrasound-guided~     axillary brachial plexus block.~   "
45094|NCT02976597|"~     Transversus abdominis plane (TAP) block is a novel type of peripheral nerve block that~     involves innervations of the anterolateral abdominal wall derived from T6-L1.It provides~     adequate post-operative pain relieve following the various abdominal surgeries.~     Theoretically, TAP block may replace the need for epidural analgesia after abdominal~     operations. The oblique subcostal approach of the TAP (OSTAP) block, which was de¬scribed by~     (Hebbard et al, 2010) , has been reported to provide analgesia to the entire anterior~     abdomen.~   "
45095|NCT02976584|"~     Primarily, the investigators want to test the hypothesis that it is possible to detect~     epileptiform EEG during cardiac surgery under general anesthesia.~      Furthermore, the investigators will examine if those epileptic potentials coincide, follow or~     are unrelated to ischemic events detected by EEG or Near-infrared spectroscopy (NIRS).~     Finally, the investigators will look for independent associations between intraoperative~     seizures (with or without ischemic events) and postoperative neurological outcome, as well as~     between intraoperative seizures (with or without ischemic events) and the total amount of TXA~     given.~   "
45096|NCT02976571|"~     A comparison between local and intraperitoneal analgetics to placebo, during laparoscopy,~     regarding post operative pain.~   "
45097|NCT02976558|"~     The allogenic stem cell transplantation (aSCT), the only curative approach for many~     hematological diseases, often leads to severe diseases or chronic conditions, leaving~     patients with physical disabilities and severe depression and impacting their quality of life~     in many cases. These consequences are still not adequately addressed by conventional~     therapies. In this study, the investigators examine the influence of the three complementary~     medicine methods (CAM) namely acupuncture according to Traditional Chinese Medicine (TCM),~     music therapy according to the TaKeTiNa method and the psychological disease processing by~     theatrical clown performance on the quality of life and the therapy process of patients~     before and after aSCT.~   "
45098|NCT02976545|"~     Currently, hypothetical models of understanding Psychogenic Non-epileptic Seizures (PNES)~     involve emotional dysregulation.~      The hypothesis of a disorder of emotional experience is mainly based on behavioral data and~     disturbance of autonomic responses in response to images in emotional content (Mignot et al~     2015, in submission; Bakvis et al 2013). Various imaging studies have identified brain~     structures belonging to the limbic system in particular that seem functionally impaired in~     this population. These functional connectivity abnormalities are correlated with dissociation~     scores in PNES patients (Van der Kruijs et al 2012 and 2014).~      Investigators propose to specifically study the brain activity of PNES patients during tasks~     emotional content to identify the mechanisms involved in this emotional dysregulation. This~     work is essential to understanding the mechanisms and the development of new therapeutic~     strategies~   "
45099|NCT02976532|"~     The study is designed to evaluate the use of electromagnetic tracking in femoral derotation~     osteotomies. The goal is to raise the precision of the surgical procedure in order to improve~     the outcome in short- and long term. The electromagnetic tracking system is evaluated against~     a base line CT scan serving as reference standard.~   "
45100|NCT02976519|"~     The objective of this study is to investigate the safety, tolerability, and pharmacokinetics~     of BI 443651 in male and female healthy volunteers and subjects with Cystic Fibrosis (CF).~   "
45101|NCT02976506|"~     To evaluate safety and the effects of a unsupervised physical activity program (USPAP) over~     blood pressure (BP), physical fitness (PF) and quality of life (QL) of elderly hypertensive~     patients.~   "
45102|NCT02976493|"~     BMS will conduct a regulatory postmarketing surveillance (PMS) to evaluate the safety of~     elotuzumab in clinical practice in Japan.~   "
45103|NCT02976480|"~     The purpose of this study is to determine whether the irrigation or non-irrigation of a~     simple laceration treated in the emergency department has an effect on the subsequent rate of~     infection.~   "
45104|NCT02976467|"~     The purpose of the trial is the analysis of safety and efficacy of the chymase inhibitor~     BAY1142524 at a dose of 25 mg BID in comparison to placebo using a 6 months treatment period~     in patients with left-ventricular (LV) dysfunction after myocardial infarction (MI).~     BAY1142524 or placebo will be given on top of evidence-based standard of care for~     left-ventricular dysfunction after myocardial infarction. Primary objective is the analysis~     of first signs of efficacy as determined by favourable changes in functional parameters of~     adverse cardiac remodelling (i.e. endsystolic and enddiastolic volume index, ejection~     fraction). Secondary objective is the analysis of safety and tolerability as evidenced by the~     incidence and severity of adverse events. 30 patients have to complete treatment with verum~     and 30 patients have to complete treatment with placebo.~   "
45105|NCT02976454|"~     One-third of our nations' children are overweight or obese (OW/OB). The cornerstone of~     obesity treatment involves intensive family-based behavioral therapy, yet these programs~     often exist in tertiary care academic settings that have long wait lists and are too far away~     for families to access. Primary care providers (PCP) have been called on by several~     organizations to be the front line of obesity management, yet they are limited by a lack of~     time, resources, and skills. Thus, if we are to offer effective obesity management in the~     healthcare setting, other care models need to be developed and tested. The goal of this~     proposal is to deliver Guided Self-Help (GSH) treatment of childhood obesity in the primary~     care setting. This program relies on classic behavioral therapy strategies, self-regulation~     theory, and provides the support needed for patient/family self-management of weight loss.~     Implementing this program in the primary care setting will increase our ability to deliver~     nutrition and weight-related counseling in the primary care office and serve patients closer~     to home, thereby increasing access to effective treatment, improving adherence to recommended~     changes, and meeting the goals of Healthy People 2020.~   "
45106|NCT02976441|"~     The investigators hypothesize that this study will show that sufficient lymphocyte stem cell~     can be harvested prior chemoradiation and be reinfused back after treatment, and at least 5~     of the 10 patients (50%) will achieve an absolute increase of lymphocyte counts of 300~     cells/mm^3 four weeks after stem cell reinfusion in high grade glioma patients.~   "
45168|NCT02975635|"~     Partially defective dental restorations might either be treated by complete replacement or by~     repair of the affected region. Repair restorations are a scientifically proven approach to~     manage failed restorations, but probably unknown to most patients. Results from this study~     and findings on the predictors of patients' therapy decisions might improve future patient~     information documents.~   "
45107|NCT02976428|"~     To ensure a successful outcome after total knee replacement (TKR) soft tissue balance and~     proper implant position are very important during the surgical procedure. Soft tissues are~     structures in the knee including ligaments, muscles, tendons, and menisci that stabilize and~     cushion the knee joint. Lack of proper soft tissue balance or imprecise implant positioning~     may result in knee stiffness, pain, instability and limited range of motion (ROM). This may~     result in implant failure and the need for revision surgery. As part of standard practice~     orthopedic surgeons use a manual knee balancer device to help guide soft tissue balancing to~     achieve optimal knee balance. New sensor-assisted technology can provide surgeons with~     measurable information to help achieve soft tissue balancing, providing surgeons with~     immediate visual feedback during the surgery. This feedback, transmitted wirelessly by the~     sensor, gives surgeons electronic information on soft tissue balance and implant position.The~     purpose of this study is to determine if a sensor guided soft tissue balancing device~     (Verasense) is more effective at balancing the knee during surgery as compared to standard~     soft tissue balancing performed with a manual balancer device.~   "
45108|NCT02976415|"~     The purpose of this study is to determine if in-bed cycling is safe and feasible in~     critically-ill patients after open heart surgery. The investigators hypothesize that in-bed~     cycling can be safely used with this population and that it is feasible to use in a~     fast-paced cardiac intensive care unit.~   "
45109|NCT02976402|"~     The present phase I trial evaluates the feasibility of a postoperative stereotactic~     hypofractionated external beam radiation therapy delivered in patients who underwent radical~     prostatectomy with adverse pathological features or early biochemical failure. Modern~     computer-driven technology enables the implementation of ultra-high hypofractionated~     Image-Guided Radiotherapy (IGRT) safely.~      Eligible patients for this study are those with:~        -  Adenocarcinoma of the prostate treated with radical prostatectomy (any type of radical~          prostatectomy is permitted including retropubic, perineal, laparoscopic or robotically~          assisted; there is no time limit for the date of radical prostatectomy)~        -  Pathologic (p)T3 disease, positive margin(s), Gleason score 8-10, or seminal vesicle~          involvement~        -  Undetectable post-radical prostatectomy PSA that becomes detectable and then increases~          on 2 subsequent measurements (PSA of > 0.1 - ≤ 2.0 ng/mL)~        -  Life expectancy: 10 years~        -  ECOG performance status of 0 -1~        -  No distant metastases, based on the following workup within 60 days prior to~          registration~        -  Magnetic resonance imaging (MRI) of the pelvis~        -  PSMA/Choline Positron Emission Tomography (PET) to exclude systemic disease in patients~          with biochemical recurrence~        -  Patients can be on androgen deprivation therapy~        -  Ability to understand and willingness to sign a study-specific informed consent prior to~          study.~      Patients enrolled in the study will undergo image-guided, volumetric intensity-modulated arc~     radiotherapy (IGRT-VMAT) with state-of-the-art treatment-planning and quality assurance~     procedures with emphasis on normal tissue sparing and delivery accuracy via the use of~     devices that ensure stability and beam location reproducibility.~   "
45110|NCT02976389|"~     The specific aims of this proposal are to implement SCNIP in 6 Northgate Gonzalez Markets~     across San Diego, Orange and LA counties (2 in each county), and determine which level of~     financial incentive rebate (specifically, $10/month, $20/month, or $40/month) optimally~     increases the purchase and consumption of SNAP eligible fruits and vegetables.~   "
45111|NCT02976376|"~     Study to investigate whether a smart technology intervention can improve clinical and~     cost-effectiveness of one-year follow-up in patients who suffered from acute myocardial~     infarction.~   "
45112|NCT02976363|"~     Objective: The purpose of this research was to study the Maximal Respiratory Pressures (MRP)~     after exposure to breast radiation therapy in women. Methods: Prospective observational study~     performed at the Hospital de cancer Alfred in Campo Grande/MS. The sample of this study~     consisted of women (N = 16) divided into two groups: women exposed to breast radiotherapy~     after underwent quadrantectomy surgery (n = 8); and women with no history of cancer (n = 8).~     We evaluated the strength of respiratory muscles through the Maximal Inspiratory Pressure~     (MIP) and Maximal Expiratory Pressure (MEP) using the handset called manovacuometer. The~     examination was performed before the first session and after the twenty-fifth session related~     to the last day of the radiation treatment; evaluation of anthropometric data of weight and~     height to detect the body mass index (BMI); evaluation of clinical respiratory symptoms of~     dyspnea using the Medical Research Council (MRC) Dyspnea Scale and characterization of cough~     with Common Pulmonary Toxicity Criteria, in the classification of clinical pneumonitis.~   "
45113|NCT02976350|"~     The objective of this study is to describe the prevalence of Multiple Hormone Deficiencies in~     Heart Failure with preserved Ejection Fraction.~   "
45114|NCT02976337|"~     Recent studies have focused on the role of endogenous opioids on central sensitization.~     Central sensitization is known to be impaired or altered in chronic pain conditions, as~     fibromyalgia or chronic tension headache.~      Animal studies have shown reinstatement of mechanical hypersensitivity following naloxone~     administration after resolution of an injury. This suggests latent sensitization. In the~     present study, the investigators hypothesize that a high-dose target-controlled naloxone~     infusion (total dose: 3.25 mg/kg) can reinstate pain and hyperalgesia 6-8 weeks after a~     unilateral primary open groin hernia repair procedure. The investigators aim to show that~     latent sensitization is present in humans and is modulated by endogenous opioids.~   "
45115|NCT02976324|"~     This study evaluates the effect of external diaphragmatic pacemaker on the patients with~     chronic cor pulmonale. Half of participants will receive external diaphragmatic pacemaker,~     while the other half will receive routine therapy.~   "
45116|NCT02976311|"~     In this study, the investigators aimed to find out whether there are any differences in~     inflammatory reactions occured subsequent to two different cesarean delivery techniques;~     modified Misgav-Ladach vs Pfannenstiel-Kerr techniques.~   "
45169|NCT02975622|"~     Ultrasound (US)-guided central venous catheterization is now considered standard of care~     according to recent clinical evidence, at least considering jugular vein approach. Recent~     trials suggested that even US-guided subclavian approach could be more effective that~     landmark technique. However, studies comparing both sites employing US are still lacking.~      We, therefore, designed a non-inferiority randomized controlled trial to compare these sites,~     both using US guidance, according to immediate complications following central venous~     catheterization.~   "
45117|NCT02976298|"~     In human, the physiology of gait and balance is not clearly established. By using functional~     imaging and electrophysiological techniques, various brain regions from the cortex to the~     midbrain area, including the cerebellum, have been identified as involved in such control.~     The specific role of these structures in both the capacity to go forward (locomotion) and~     stand upright (balance), but also in the different phases of the gait initiation process, are~     not known, however. In this study,the investigators aimed to assess the specific role of both~     the supplementary motor area (SMA) and the cerebellum in postural control during the~     initiation of gait. For this purpose, the investigators plan to study the gait initiation in~     20 healthy subjects before and after functional inactivation (using inhibitory repetitive~     transcranial magnetic stimulation, rTMS) of the cerebellum or SMA. Biomechanical, kinematic~     and electromyographic parameters of the gait initiation will be recorded using a force~     platform, reflective markers with infrared cameras (VICON system) and lower limbs surface EMG~     electrodes.~   "
45118|NCT02976285|"~     The purpose of this study was to assess the impact and potential advantage of a novel~     synthetic patch augmentation in repair of massive rotator cuff (RC) tears, using clinical and~     radiological approaches. The investigators hypothesized that implanting this patch will~     improve individual shoulder function, while reducing re-tear rates compared to the current~     literature.~   "
45119|NCT02976272|"~     Chemotherapy-induced peripheral neuropathies (CIPN) remain a problem in oncology because no~     gold standard treatment exists to prevent or treat the CIPN. Therefore, oncologists reduce~     or stop the chemotherapy doses to limit degradation of the quality of life of patients with~     CIPN. Bortezomib is relatively understudied while neurotoxicity remains a limiting factor for~     treatment. Since 2012, the FDA and the EMA validated by the administration of bortezomib~     subcutaneously (SC) instead of intravenous (IV) in order to limit neurotoxicity.~      However, a retrospective study reported that the prevalence of neuropathy induced by~     bortezomib after SC administration remains high and equivalent to IV route. No studies have~     quantitatively and qualitatively evaluated the sensory disorders in peripheral neuropathies~     induced by bortezomib after SC administration. On the other hand, the QLQ-CIPN20~     questionnaire (EORTC) evaluating the intensity of sensory, motor and autonomic disorders~     associated with CIPN has never been tested in this population. The objective of this study is~     twofold: (i) psychophysical evaluation of neuropathic disorders by studying the thermal and~     vibratory detection thresholds and thermal nociceptive thresholds and (ii) quantitative and~     qualitative assessment of neuropathic disorders by the QLQ-CIPN20 and related comorbidities~     in a population of neuropathic patients treated with bortezomib (n = 15), compared to control~     patients treated with bortezomib but non-neuropathic (n = 45).~   "
45120|NCT02976259|"~     Sponsor: IMEA - Fondation Internationale Léon Mba C.H.U. Bichat - Claude Bernard 46, Rue~     Henri Huchard - 75018 PARIS Tél. : 01.40. 25. 63. 65 - Fax : 01.40.25.63.56~      Coordinating investigator:~      Dr Caroline Lascoux Combe Hôpital Saint Louis Service Maladies Infectieuses~      1 avenue Claude Vellefaux - 75010 PARIS Tél. : 01 42 49 49 73 - Fax : 01 42 49 47 43 E-mail :~     caroline.lascoux-combe@aphp.fr~      Participating country : FRANCE~      Primary objective : Comparing the kinetic of HIV-RNA decay in blood plasma and in seminal~     plasma in patients starting a triple combination regimen with dolutegravir + tenofovir DF~     (TDF) + emtricitabine (FTC) at the time of PHI.~      Secondary objectives :~        -  Comparison of HIV-1 RNA level in plasma (threshold 20 and 1 copies/ml) and in seminal~          plasma (threshold 60 copies/ml) at each visit D0, W2, W4, W8, W12, W24, W36, W48~        -  To assess the frequency of intermittent shedding in seminal plasma once virological~          suppression has been achieved and until W48~        -  Evolution of cellular HIV-1 DNA level in PBMC and in non-sperm cells between D0 and W48~        -  Comparison of dolutegravir concentration in blood plasma and seminal plasma~        -  Study of risk factors associated with viral persistence of HIV-RNA in the seminal plasma~        -  Analysis by deep sequencing of the viral population (quasi-species) in both compartments~          (blood plasma and seminal plasma) before virological suppression has been achieved (i.e.~          at D0 and W12)~      Inclusion criteria :~        -  Patients diagnosed at the time of primary HIV infection (PHI) (i) a negative or~          indeterminate HIV ELISA associated with a positive antigenemia or plasma HIV RNA, (ii) a~          western blot profile compatible with ongoing seroconversion (incomplete western blot~          with absence of antibodies to pol proteins (p34, p68)) or (iii) an initially negative~          test for HIV antibodies followed within 3 months by a positive HIV serology~        -  Treatment including dolutegravir (DTG 50mg) + tenofovir/emtricitabine (TDF/FTC 245~          mg/200 mg) initiated by the referee physician within a maximum of 15 days after~          diagnosis of PHI~        -  Genotypic sensitivity to TDF, FTC and DTG~        -  Patient with medical care insurance~      Exclusion criteria :~        -  Chronic infection~        -  Infection or co-infection with HIV-2~      Study treatment : Dolutegravir and tenofovir/emtricitabine Number of subjets : 20 patients~     (exploratory study)~   "
45121|NCT02976246|"~     Cardiovascular disease (CVD) is the most frequent cause of death in patients (ptt.) with~     chronic kidney disease (CKD). Compared to the general population death due to CVD is 10-20~     times higher in CKD ptt. being treated with hemodialysis. Vascular calcification and hence~     arterial stiffness is of great importance for the high incidence of CVD.~      CKD ptt. in dialysis treatment also have a 3 times higher risk of bone fractures. Both~     vertebral and other fractures of low energy are associated with a high mortality.~      Matrix Gla Protein (MGP) is an important inhibitor of vascular calcification and Osteocalcin~     (OC) is an important regulator of bone metabolism. The function of both MGP and OC depend on~     vitamin K.~      Vitamin K is supplied with food. The content is low in food recommended to CKD ptt. which is~     reflected in very low concentrations of vitamin K in their blood samples. A correlation~     between vitamin K level, incidence of vascular calcification and bone density has been~     proven; yet there are no trials elucidating the clinical effect of vitamin K on vascular~     calcification or bone strength.~      The investigators will conduct a randomized placebo controlled trial examining the clinical~     effects of vitamin K2 on vascular calcification and bone mineralization in order to prevent~     and treat CVD and bone disease in CKD ptt.~      Primary study endpoints:~        1. Changes in arterial stiffness assessed by pulse wave examination~        2. Changes in bone mineral density (BMD) in distal radius assessed by DXA-scans.~      Secondary study endpoints:~      Changes in coronary artery and valvular calcification assessed by heart-CT-scans, blood~     pressure, body composition, total and regional BMD, lateral column/aortic calcification score~     as well as a panel of correlating blood tests.~   "
45170|NCT02975609|"~     This protocol is a phase II randomized controlled trial (RCT) evaluating the efficacy of SBRT~     compared with conventional fractionated radiotherapy for oligometastatic Non-Small Cell Lung~     Cancer~   "
45171|NCT02975596|"~     As part of an effort to increase MenB vaccine uptake among adolescents and young adults,~     study teams will conduct qualitative research to maximize the effectiveness of nationally~     recommended MenB educational materials. In this study, Study Teams will assess local barriers~     to MenB vaccination by conducting focus groups with parents, students, and health care~     professionals.~   "
45214|NCT02975037|"~     Evaluation and validation of metabolic markers for the prediction of drug-drug interaction of~     various CYP3A4 substrates (sildenafil) and inhibitors (erythromycin/itraconazole) in healthy~     male subjects~   "
45122|NCT02976233|"~     Over the last two decades, non-invasive ventilation (NIV) has been widely reported as an~     effective method to avoid the need of endotracheal intubation (ETI) and improve survival in~     the acute care setting. Given the risks associated with either premature NIV discontinuation~     or delays in NIV interruption, evaluating readiness to weaning from NIV is a critical~     challenge in patients with Acute Respiratory Failure (ARF).~      Up to date, bedside measurements used to predict NIV outcomes are extremely limited. NIV~     weaning as well as decision of ETI are mainly supported by clinical and physiologic~     parameters. More sophisticated techniques used to predict weaning outcome during spontaneous~     breathing trials have never achieved a bedside broad-spectrum use due to their invasiveness,~     the inconsistent results in demonstrating reproducible outcomes, the requirements of~     additional trainee personnel and complicated equipment, and the difficult application in~     awake and non-intubated patients.~      Recently, ultrasound has been used for the rapid assessment of diaphragm function in acutely~     ill patients. The advantages of the ultrasound in detecting diaphragm dysfunction as compared~     with other techniques are the less invasiveness, the avoidance of radiation hazards and the~     bedside feasibility. Direct imaging of changes in diaphragm thickening (DT) during~     spontaneous breathing may provide the assessment of both the muscle and the respiratory pump~     functioning. Indeed, DT has been correlated with the diaphragm strength and the muscle~     shortening. The volume of diaphragm muscle mass remains constant while it contracts.~     Consequently, as the muscle shortens it thickens itself and measurements of changes in such a~     thickening (DT) are inversely related to changes in diaphragm length. Studies in patients~     with diaphragm paralysis have confirmed the absence of DT. Moreover, since the diaphragm is~     the major muscle of inspiration, the presence of diaphragm shortening and contraction may~     predict successful extubation in patients who are invasively ventilated.~      The aim of the present study is to assess whether DT as measured by ultrasound may predict~     NIV outcome in patients with de-novo ARF admitted to the Emergency Department (ED).~   "
45123|NCT02976220|"~     This study is designed to evaluate the feasibility of using digital-enabled education in~     clinical care in order to improve patient outcomes related to end-stage renal disease (ESRD).~     If effective, educational interventions could be used to improve the long-term survival of~     patients with chronic kidney disease (CKD) and to make clinical care for these patients more~     cost effective.~   "
45124|NCT02976207|"~     Long follow up on patients with obstructive sleep apnea that undergo diagnosis and surgical~     treatment~   "
45125|NCT02976194|"~     Changes of intraocular cytokines including vascular endothelial growth factor (VEGF) will be~     measured in recurrence of polypoidal choroidal vasculopathy (PCV) during treatment of~     ranibizumab.~   "
45126|NCT02976181|"~     Medtronic is sponsoring a quality improvement study called Brady MX. It is hypothesized that~     lack of awareness of treatment and diagnostics pathways result in lower number of referrals~     to implanters of IPG.~   "
45127|NCT02976168|"~     The aim of the study is to understand the relationship between intracranial pressure~     regulation, cerebral tissue oxygenation and cognitive functioning. More specifically, the~     study tests the hypothesis that head down tilt will increase intracranial pressure (not~     measured in this study, but demonstrated in previous studies), will induce venous congestion~     and facial swelling, decrease intracranial tissue oxygenation and hamper brain functioning.~     The objectives of the study therefore are to assess young healthy people during head-down~     tilt (HDT), and to assess cognitive brain functioning, cerebral tissue oxygenation~     (non-invasively), frontal skin thickness, cerebral perfusion and neuronal functioning via~     event-related potentials.~   "
45128|NCT02976155|"~     The goal of this study is to evaluate whether a standard enteral nutrition protocol can~     improve the efficiency in achieving nutritional goals and improve prognosis in critically ill~     patients.~   "
45129|NCT02976142|"~     The purpose of this study is to determine whether intraperitoneal immunotherapy (with~     interleykin-2 - human cytokine reaction activator) with systemic chemotherapy will be more~     effective than systemic chemotherapy alone in patients with gastric cancer and verified free~     cancer cells in abdominal cavity in improving the long term outcomes and overall survival of~     further surgical treatment.~   "
45130|NCT02976129|"~     The purpose of this study is to evaluate the efficacy and safety of V565 in participants with~     active Crohn's Disease.~   "
45131|NCT02976116|"~     Fruquintinib in combination with Gefitinib as first-line therapy in patients with advanced~     non-squamous non-small-cell lung cancer harboring activating EGFR mutations : a single-arm,~     multicenter, phase II study~   "
45132|NCT02976103|"~     This research study is studying a garment called the Jacki® recovery jacket that can be worn~     after surgery as a possible way to manage pain from surgical drains.~      The study intervention involved in this study is:~      -Jacki recovery jacket~   "
45133|NCT02976090|"~     Despite the fact that small intestine makes up 75% of the length of the digestive tract and~     90% of its mucosal surface area, small bowel adenocarcinoma (SBA) is rare. SBA is not equally~     dispatched along the small bowel, a predisposing disease is frequently associated. All these~     data suggest particular carcinogenesis pathway. SBA carries poor prognosis at all stages and~     no standard treatment have proved efficacy. So far, no data are available for targeted~     therapy. From the literature and a previous study of our group some biologic data showed that~     SBA carcinogenesis is closer to colorectal than gastric carcinogenesis. Nevertheless, some~     differences arise (ie: low Adenomatous Polyposis Coli mutation rate or frequent DNA mismatch~     repair deficiency). Even if some trends are founded the prognostic value of molecular~     alteration and phenotype variation according to small bowel segment, or predisposing disease~     could not been demonstrate due to small sample size.~      BIONADEGE study is a planned biologic ancillary study of the NADEGE cohort that enrolled 366~     patients with SBA from 2009 to 2012 in France. The tumour blocks and clinical data of 187~     patients have been collected. The main objective is to assess the prognostic value for~     recurrence free survival (RFS) in non-metastatic patients and overall survival (OS) in~     metastatic patients of molecular alteration in a set of 46 genes and abnormal protein~     expression potentially implicated in carcinogenesis. The mains secondary objectives are: 1)~     to identify potential mutation targetable in small intestine tumours and protein expression,~     2) to state the frequency of molecular alteration according to the tumour location, stage or~     predisposing disease and established clinico-biologic correlation. Tissue microarrays will be~     performed and several potential prognostic markers will be assessed. Sequencing on tumour DNA~     will investigate the presence of 740 hot spot somatic mutations in 46 genes involved.The~     abnormal protein expression or the genetic alterations with an expected frequency superior to~     10% will be assessed as potential prognostic factor to RFS and OS.~      These evaluations on a large cohort could allow comparison between pathways and will offer~     better knowledge of tumour molecular phenotype and prognosis will give rational for targeted~     therapy trials The predisposing diseases for SBA involved several different carcinogenesis~     pathways. Finally, a molecular classification of SBA will be attempt.~   "
45181|NCT02975466|"~     A can't intubate, can't oxygenate situation is life-threatening and the physician must be~     prepared to react quickly. Similarly, a difficult intubation with adequate ventilation is~     associated with complications. In both of these situation and as recommend by different~     societies, a supra-glottic airway (SGA) device can be used to help ventilation, or as an~     intubation conduit to ease the airway access. The objective of this randomized controlled~     trial is to establish which SGA, between the AuraGain, AirQ Blocker and I-Gel, allows the~     fastest intubation time in an adult population, with the objective of minimizing~     complications related to these situations. The investigators will conduct a three-arm trial~     to compare different outcomes related to the installation of the SGA and its use as an~     intubation conduit. The results of this trial will inform the anesthesiologist on which~     device to use on to have close in case of airway emergencies.~   "
45134|NCT02976077|"~     Background:~      Difficulties in social interactions are a central characteristic of people with~     schizophrenia, and can be partly explained by impairments of social cognitive processes.~     According to renown researchers, three to five social cognitive processes are usually altered~     in schizophrenia: (1) emotional processing; (2) theory of mind (ToM); (3) attributional~     style; and (4 and 5) social perception and knowledge. The components of social cognition~     appear to be related to both symptomatology and functioning in everyday life.~      New strategies of cognitive remediation have been recently developed to target these deficits~     and few meta analyses have assessed the extent to which social cognitive remediation programs~     have led to multiple improvements for schizophrenia patients. Overall, it seems that such~     therapies showed encouraging results in both patient interest and motivation, and social~     cognitive processes.~      The RC2S therapy is the first individualized and partly computerized program through which~     patients practice social interactions and develop social cognitive abilities with simulation~     techniques in a realistic environment.~   "
45135|NCT02976064|"~     Background: The growing awareness on the health burden generated by insufficient levels of~     physical activity has prompted the interest for deploying community-based initiatives aiming~     at fostering active healthy living. It is of note, however, that, to our knowledge, none of~     the interventions evaluated so far have reached large scale adoption. The current protocol~     relies on the general hypothesis that properly tailored self-management programs, fully~     integrated in the patient's action plan with remote off-line professional support, may induce~     sustained behavioral changes resulting in exercise health behavior. Accordingly, the current~     manuscript addresses those unmet requirements, namely: i) Workflow design of the PA services~     engaging both patients and health professionals; ii) Enhanced information and communication~     technologies (ICT)-support; iii) Evaluation strategies including structured indicators; and,~     iv) Implementation of innovative business models. The main outcome of the current protocol~     will be a roadmap for large scale deployment and assessment of novel collaborative~     self-management PA services in the region of Catalonia (7.5 million citizens).~      Methods: The protocol has been designed as part of the regional deployment of integrated care~     services in Catalonia (2016-2020). It has been conceived has a two-year (2017-2018) test bed~     period.~      Aims: The protocol uses a population-health approach to addresses the four aims: i)~     Prehabilitation for high risk candidates to major surgery; ii) Community-based rehabilitation~     for clinical stable chronic patients with moderate to severe disease; and, iii) Promotion of~     physical activity and healthy lifestyles for citizens at risk and patients with mild disease.~   "
45136|NCT02976051|"~     Aim: To improve curability of radiotherapy in HNSCC patients identified by hypoxic FAZA-PET~     scanning~   "
45137|NCT02976038|"~     This is a Phase 2 Open-Label extension study to evaluate the long term safety and~     tolerability of daily elamipretide injections in patients with genetically confirmed Primary~     Mitochondrial Disease who previously participated in the SPIMM-202 Clinical Trial~   "
45138|NCT02976025|"~     This study evaluates the impact of a longitudinal remote consultation (LRC) implementation~     strategy for collaborative care depression treatment among perinatal women receiving care~     from federally qualified health centers (FQHCs). All participating health centers will~     receive training in collaborative care. Cluster randomization will be used to assign the~     addition of LRC to select health centers. Differences in implementation success, clinical~     outcomes, and costs will be compared after a 12 month implementation period and 13-21 month~     sustainment period.~   "
45139|NCT02976012|"~     This is a phase I/II open label, randomized, interventional clinical trial. Study eyes will~     receive one preoperative intravitreal aflibercept injection (IAI) <21 days but >7 days prior~     to vitrectomy and one intraoperative IAI at end of surgery followed by randomization in a 1:1~     ratio into either 4 mandatory postoperative q4weeks IAI followed by mandatory q8 weeks IAI~     for 52 weeks follow-up (q8 week Group) or 2 mandatory postoperative q4weeks IAI followed by~     mandatory q16 weeks IAI for 52 weeks follow-up (q16 week Group).~   "
45140|NCT02975999|"~     The purpose of this study is to determine whether Vasopressin following the Fontan operation~     will decrease chest tube output and duration.~   "
45141|NCT02975986|"~     The investigators will test the hypothesis that renal uptake of free (i.e. non-esterified)~     fatty acids (FFa) is increased in iuan. To accomplish this goal the investigators will~     measure renal FFa uptake FFa uptake in vivo in patients with iuan and matched non-stone~     forming subjects via single-photon emission computed tomography (SPeCT)/CT imaging.~      The definitive proof of the hypothesis rests on whether increased renal FFa uptake is~     demonstrable in humans with iuan.~   "
45142|NCT02975973|"~     Cognitive impairments in schizophrenia are the most debilitating aspect of the illness and~     poorly treated by current medications. This study investigates transcranial direct current~     stimulation (tDCS) - a safe, noninvasive weak electrical current delivery to stimulate brain~     function - as a novel therapeutic for cognition in schizophrenia. Integrating~     neurostimulation, electrophysiology and neuroimaging, this project aims to study tDCS effects~     on cognition by verifying therapeutic target engagement, evaluating the tolerability of tDCS~     sessions, and optimizing treatment parameters.~   "
45143|NCT02975960|"~     Systemic sclerosis (SSc) is a rare autoimmune disease, mainly characterized by cutaneous and~     visceral fibrosis. Digital ulcer and sclerosing skin are commonly affected on hands, but the~     treatment for these manifestations are often ineffective.~      Adipose tissue contains stromal vascular fraction (SVF), which is abundant multipotent stem~     cells, capable of tissue repair. A prior study (NCT01813279) has shown the safety and~     tolerance at 6 months of the subcutaneous injection of SVF in the fingers in SSc.~      There are only few ways to manage SSc patients with skin lesion who already have treated with~     several medications (including vasodilators, PDE5 inhibitor, endothelin receptor antagonist)~     but some times their skin lesions are critical physically and emotionally.~      Autologous SVF injection could be one of the treatment options to treat skin lesion of SSc.~     Thus, the investigators study the efficacy and potential adverse event in Korean patients~     with SSc.~   "
45182|NCT02975453|"~     Evaluation of the performance of the 2MACE index in a population of nonvalvular atrial~     fibrillation (NVAF) patients treated with rivaroxaban in Spain~   "
45183|NCT02975440|"~     This study will be conducted in a single center, open-label study with a single group fixed~     sequence design to evaluate the effect of repeated oral administration of 600 mg~     RIF(Rifampicin) given once daily over 11 days on the single oral dose pharmacokinetics of~     VPR(Vilaprisan) and on MDZ(Midazolam) as a reference (probe) substance.~   "
45144|NCT02975947|"~     The operating theatre is deliberately made to be cold and dry to prevent bacteria from~     growing. The problem with this is that during open abdominal surgery, the intestine and the~     overlying peritoneum is exposed to cold dry air. Surgeons try to stop the bowel/peritoneum~     from drying by applying warmed saline packs periodically to the bowel. However, this is not~     always possible. Sometimes, the surgeon has to perform an important component of the~     procedure (attach bowel/blood vessels together etc) and the bowel/peritoneum visibly dries.~     When bowel/peritoneum dries damage occurs, inducing inflammation. Inflamed bowel/peritoneum~     causes the bowel to stick together and form adhesions. Bowel adhesions can cause bowel~     obstruction. This vicious cycle is repeated when the patient undergoes repetitive open~     abdominal operations.~      This study aimed to be the first human study to:~        1. Demonstrate that peritoneal inflammation occurs during open abdominal surgery and also~          to demonstrate that pro-inflammatory cells (polymorphs, macrophages) are activated~          during the progress of the operation. This study aims to show that mRNA(using Q-PCR) is~          increased for pro-inflammatory cytokines. This study also aim to show that~          proinflammatory cytokines (Interleukin(IL)-1,2,6,9,10, and TNF by ELISA/confirmed using~          Western Blotting) are elevated during the course of the operation.~        2. Demonstrate that the mechanism of bowel/peritoneal inflammation is causally related to~          the bowel/peritoneum drying (dessication).~      This study will attempt to prove this by using humidified, warmed carbon dioxide gas which~     will warm and moisten the peritoneum/bowel. It is proposed that this will arrest the~     peritoneal injury and the inflammation. The investigators will attain peritoneal samples~     during open colorectal operations. The investigators will obtain samples at the beginning and~     end of the operation. This study design is a randomized controlled trial, where half the~     patients will receive humidified, warmed carbon dioxide gas during surgery, and the other~     half will get standard open surgery without carbon dioxide. 40 patients will be recruited in~     this study. Half (20) will get CO2, and other half (20) will get standard open surgery.~   "
45145|NCT02975934|"~     The purpose of this study is to determine how patients with metastatic castration-resistant~     prostate cancer, and evidence of a homologous recombination gene deficiency, respond to~     treatment with rucaparib versus treatment with physician's choice of abiraterone acetate,~     enzalutamide, or docetaxel.~   "
45146|NCT02975921|"~     The purpose of this study is to determine whether betadine (povidone-iodine) instillation~     during routine indwelling Tunneled Pleural Catheter (TPC) placement is efficacious in~     promoting pleurodesis and thus reducing the time to TPC removal.~   "
45147|NCT02975908|"~     ARDS is a critical respiratory disease caused by endogenous and exogenous factors. The~     mortality of ARDS varies from 30 to 70%. In 2012, a new international diagnostic criterion~     has been put forward. Yet, its feasibility, reliability and validity need to be tested.~     Meanwhile, the correlation of different severity and prognosis remains unclear. As so far,~     the epidemiological information about ARDS in China is lacking.~      Investigators plan to conduct a multi-center observational study（real-life study） to~     investigate the risk factors, morbidity, management and prognosis of ARDS in China, in order~     to facilitate standardization of diagnosis and management of ARDS and provide basic data and~     idea for further clinical intervention studies.~   "
45148|NCT02975895|"~     Cataract, is a clouding of the lens in the eye gradually leading to reduction of the visual~     acuity. In most cases it can be managed with surgery, removing the own lens and replacing it~     with an artificial lens, intraocular lens (IOL). These lenses are made in different materials~     with different properties.~      Uveitis refers to an inflammation in the iris, ciliary body and choroid. Patients with this~     disease have an increased risk of developing cataract due to the inflammation itself and~     treatment with steroids. They also have an increased risk of complications during surgery and~     postoperatively. In this group the selection of IOL might be of greater importance.~      The aim of this prospective randomized controlled study is to compare the outcome of~     hydrophobic and hydrophilic intraocular lenses in patients with and without uveitis~   "
45149|NCT02975882|"~     This phase I trial studies the side effects and best dose of nanoparticle albumin-bound~     rapamycin when given together with temozolomide and irinotecan hydrochloride in treating~     pediatric patients with solid tumors that have come back after a period of time during which~     the tumor could not be detected or has not responded to treatment. Nanoparticle albumin-bound~     rapamycin may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Drugs used in chemotherapy, such as temozolomide and irinotecan hydrochloride, work~     in different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Giving nanoparticle albumin-bound~     rapamycin, temozolomide, and irinotecan hydrochloride may work better in treating pediatric~     patients with solid tumors.~   "
45150|NCT02975869|"~     This research study is evaluating the impact a collaborative palliative care and oncology~     team will have on the quality of life, symptoms, mood, and end of life outcomes of patients~     with acute myeloid leukemia (AML). Palliative care is a medical specialty focused on~     lessening (or palliating) symptoms and assisting in coping with serious illness.~   "
45151|NCT02975856|"~     The main aim of this study is to evaluate the bioavailability of table red wine and young~     Port red wine anthocyanins in healthy men.~   "
45152|NCT02975843|"~     The purpose of this study is to investigate the lung deposition and distribution pattern of~     Beclometasone dipropionate/Formoterol Fumarate/Glycopyrronium Bromide using a~     Gamma-scintigraphic technique after inhalation of a single dose of 99mTc radiolabelled CHF~     5993 Administered via pMDI in healthy volunteers, asthmatic and COPD patients.~   "
45153|NCT02975830|"~     Accurate understanding of tracheobronchial anatomy is important for application of various~     airway maneuvers in anesthesiology in children. Majority of pediatric anesthesia textbooks~     state that the anatomic orientation of the right main bronchus is at less acute angle to the~     vertical tracheal axis, although these angles tend to be similar in children younger than~     three years of ageThe visualization of the air column in tracheobronchial tree in a~     three-dimensional (3D) CT-based image is clear with the air column simulating the actual~     internal shape of the airway.~      We hypothesize that RBA and LBA are unequal as children like adults are prone to right~     mainstem intubation We have measured the right and left bronchial angle using the three~     dimensional CT based images of the air column in the tracheobronchial tree.~   "
45154|NCT02975817|"~     The investigators wish to undertake a randomized controlled non-inferiority trial to evaluate~     the ability of a simple and low-cost method (Hibler´s method of wrapping the patient in~     multiple insulating layers) to prevent intraoperative heat-loss in children undergoing~     neurosurgery under anesthesia in Malawi. The control group will be heated actively with the~     use of warm-air blankets. The aim of this study is to evaluate whether Hibler´s method can~     provide a cheap and technically simple way of adequately preserving the patients´ core~     temperature in the operating theatre in a resource-poor setting.~   "
45184|NCT02975427|"~     Prospective, single arm, dietary intervention study.~   "
45185|NCT02975414|"~     The purpose of this study is the measurement of the evolution of the operation time during~     the start-up phase of robotic assisted surgery for the treatment of incisional hernia`s of 40~     patients treated in Maria Middelares in laparoscopic rTARUP technique.~   "
45155|NCT02975804|"~     Objectives:~      This proposal is to investigate the effect of a 6-week training programme using an~     Interactive computer play (ICP) on the trunk control, balance and gross motor function in~     children with cerebral palsy (CP).~      Hypothesis to be tested:~      The trunk control, balance and gross motor function of children with CP will be significantly~     improved after the ICP programme.~      Design and subjects:~      20 children (6 to 12 years old) with CP will be recruited in this pilot randomised controlled~     trial. The children will be randomly allocated into a control or treatment group (10 children~     in each arm).~      Study instruments:~      Tymo is a wireless force plate used for assessment and training.~      Intervention:~      An ICP program will be set up using the Tymo. The child uses their trunk movements in the ICP~     in sitting during the intervention. The children will receive the intervention 4 times/week,~     20 minutes/session for 6 weeks. All children will be assessed at the beginning, 3, 6 and 12~     weeks post-intervention.~      Main outcome measures:~        -  Segmental Assessment on Trunk control~        -  Pediatric Reach Test~        -  Gross Motor Function Measure 88 (GMFM 88)~        -  2-minute walk test~      Data analysis:~      As a pilot study, 20 children will be recruited for this study. Independent t-test or Mann~     Whitney U test will be used to compare the continuous and ordinal results between the~     intervention and control groups.~      Expected results:~      The trunk control, balance and gross motor function of children with CP will be significantly~     improved after the intervention.~      Clinical significance and potential of the study:~      This is clinical trial to examine the effectiveness of a new intervention, a kind of~     interactive computer play training module, on training the trunk control for children with~     cerebral palsy. If the intervention is proven effective, it may be an adjunct to the~     conventional Physiotherapy to children with movement disorders in enhancing their trunk~     control. Better trunk control will in turn improve the daily function for these children as~     their sitting and standing balance is improved. In a long run, these children will not rely~     on expensive seating equipment to maintain their balance during schooling and at home.~   "
45156|NCT02975791|"~     After a structured teaching program anaesthetists are educated in identifying the~     cricothyroid membrane with ultrasonography. Thereafter their ability to do so is compared~     with their ability to do so with palpation. In an obese volunteer~   "
45157|NCT02975778|"~     The purpose of the project is to validate the use of Pain Monitor™ device, not invasive and~     simple of employment, for old people able to answer to a digital scale of pain intensity.~      The main objective is to develop and to validate a model of prediction of the pain in old~     subject at the time of the care, using the measure of variation of the skin conductance.~   "
45158|NCT02975765|"~     Applying flapless piezocision corticotomies on the alveolar bone and separating anterior~     mandibular teeth using a piezosurgery device (i.e. ultrasonic waves that perform very~     accurate incisions without any sutures following this procedure) may improve the speed of~     tooth alignment during orthodontic treatment. This study consists of two groups, patients~     will be randomly assigned to one of these two groups. The levels of pain and discomfort of~     this procedure on 18 patients (experimental group) will be evaluated,whereas the second group~     (control group) will receive a traditional orthodontic therapy.~   "
45159|NCT02975752|"~     First-line treatment with afatinib prolongs overall survival in patients with metastatic~     non-small-cell lung cancer (NSCLC) harboring EGFR exon 19 deletion mutations. Conversely,~     somatic KRAS mutations are negative predictors for benefit from EGFR-targeting agents. In~     this study we want to compare a new highly sensitive method for the detection of EGFRdelEx19~     and KRAS Exon 2 with targeted-resequencing multiplex-PCR (NGS).~   "
45160|NCT02975739|"~     The main objective is to establish the feasibility of 166-Holmium microspheres for~     intratumoral injections in oral squamous cell carcinoma (OSCC) of the tongue.~      Participants will receive intratumoral injections with a low radioactive 166-Holmium~     microspheres followed by surgical resection~   "
45161|NCT02975726|"~     One complication of liver disease is the buildup of fluid within the belly. This is known as~     ascites. Patients who have ascites have a decreased appetite, pain, nausea and shortness of~     breath. Ascites is typically treated with medications, however when that does not work,~     patients need a procedure where a needle is inserted in the belly every few weeks to drain~     the excess fluid. About 2 in 5 patients with ascites from liver failure can get kidney~     disease from their worsening liver function or from the drainage of fluid with needles. Once~     patients have both advanced liver disease and kidney disease, their chance of dying largely~     increases.~      The present study will be the first of its kind to study a new technique to treat ascites.~     Investigators are planning to place a tube in a patient's belly to drain the excessive~     amounts of fluid. This technique is similar to how one type of dialysis is done to treat~     patients with kidney failure. This study is set as a pilot investigation in order to~     determine the feasibility of doing a larger, randomized clinical trial investigating the use~     of this novel technique. Importantly, advanced liver disease patients are at high risk to~     develop kidney disease, and therefore are an important group to focus on. Investigators~     believe that this technique will prevent or slow the development of kidney disease in liver~     failure patients, and improve their quality of life, far more than the current available~     treatments.~   "
45162|NCT02975713|"~     To evaluate the influence of circadian rhythm on progesterone levels during follicular phase~     of natural cycle and during follicular phase of controlled ovarian stimulation during IVF.~   "
45163|NCT02975700|"~     The purpose of this Phase I/II study is to evaluate safety, pharmacokinetics, and preliminary~     efficacy of the investigational drug PLX3397 in subjects with unresectable or metastatic~     KIT-mutated melanoma.~   "
45164|NCT02975687|"~     In this single-center, open-label, no control, prospective clinical trial, a total of 20~     resistant or refractory CD19+ B cell acute lymphoblastic leukemia (ALL) patients will be~     enrolled. CD19 CAR T cells will be administered by i.v. injection as a using a split dose~     (total dose of 5x10^6/kg-5x10^7/kg) approach to dosing:10% on day 0, 30% on day 1 and 60% on~     day 2. The purpose of current study is to determine the clinical efficacy and safety of CD19~     CAR T cells in patients with chemotherapy resistant or refractory CD19+ ALL.~   "
45165|NCT02975674|"~     The trial is designed as a consecutive enrollment prospective one-center study. A minimum of~     30 patients will be included in the study. At implant installation, the patient will be~     randomized to receive one of the two types of implants (Control: internal hexagon connection~     implants (CON.INT); Test: Morse taper connection implants (MT-12)). Samples of peri-implant~     crevicular fluid (PICF) and intrasulcular plaque will be collected at -21 (second-stage~     surgery), -14 (impressions), 0 (Baseline: prosthesis delivery), 7 days and 1, 3, 6, 12~     months. Prosthesis will be fabricated and delivered as usual, i.e., approximately two weeks~     after the impressions are taken.~   "
45166|NCT02975661|"~     Registration of patients after gastrointestinal cancer radical surgery, including the~     information of treatments, recurrence & metastasis, adverse events,etc.~   "
45167|NCT02975648|"~     The purpose of this study is to compare the effect of an educational model, which includes~     cardiac rehabilitation with emphasis on physical activity and telephone reinforcement, with~     the usual management of individuals undergoing to intervention coronary percutaneous, in~     relation to physical activity six months after discharge.~   "
45172|NCT02975583|"~     There are no medical therapies indicated for reduction of limb ischemic events. Studies of~     dual-antiplatelet therapy with aspirin and clopidogrel versus aspirin alone (CASPAR) as well~     as studies of systemic anticoagulation (WAVE) have shown no benefit for either strategy in~     the reduction in limb vascular events. Surgical bypass grafting involves harvesting of the~     vein, warm ischemia with disruption of vaso vasorum, ischemia-reperfusion, and finally~     heightened hemodynamic stress in the new arterial environment. Vein grafts rapidly remodel in~     response to the increase in blood flow and pressure in an attempt to normalize them into~     physiological range. The investigators have previously identified 3 distinct temporal phases~     of the remodeling process: During the first 30 days following implantation is a critical~     period of luminal enlargement which appears to be an endothelium-independent process. The~     second phase occurs between 1 and 3 months and represents a period of stiffening of the vein~     graft indicating synthesis of fibrous proteins. The third period is referred to as~     biochemical remodeling wherein the vein recovers clinically measureable endothelial function.~     It is likely diabetes mellitus impacts each of these phases. TRA2°P-TIMI 50 demonstrated a~     reduction in acute limb ischemic (ALI) events (42% reduction) and urgent peripheral arterial~     revascularizations (35% reduction), a finding unique among medical therapies. While the~     temporal trend in reduction in ALI events occurred early and late after exposure suggestion~     an antithrombotic mechanism, the reduction in elective revascularization occurred later~     suggested beneficial effects beyond platelet inhibition. The purpose of this trial is to~     study the physiological impact of vorapaxar on lower extremity bypass graft maturation and~     function.~   "
45173|NCT02975570|"~     The proposed study will randomize adults (18 years of age or older) with pulmonary MDR-TB~     with sputum that contains M. tuberculosis that is isoniazid and rifampin resistant by~     MTBDRplus and fluoroquinolone susceptible by MTBDRsl HIV seropositive (with or without~     antiretroviral therapy) or negative (but not unknown) and Karnofsky score of >60 at sites in~     Moldova, Peru, and the Philippines.~      Patients with MDR-TB will be randomized to oral regimen of delamanid (DLM), linezolid (LZD),~     levofloxacin (LFX) and pyrazinamide (PZA) for 24, 32, 40, 48 or 56 weeks or World Health~     Organization (WHO) standard of care MDR-TB regimen (9-month modified Bangladesh regimen or~     WHO standard MDR-TB regimen).~      Primary Objective~      1. Determine the shortest duration of the delamanid-containing oral regimen that is~     non-inferior to the blended WHO standard regimen.~      Secondary Objective~        1. Define the safety and tolerability of the oral delamanid, linezolid, levofloxacin and~          pyrazinamide regimen.~        2. Determine if baseline PZA susceptibility is associated with shorter time to non-inferior~          treatment duration.~        3. Identify the relationship between delamanid and linezolid serum drug levels and time to~          sputum culture conversion among patients on the delamanid-containing oral regimen.~        4. Identify the relationship between delamanid and linezolid serum drug levels and~          occurrence of adverse events among patients on the delamanid-containing oral regimen.~   "
45174|NCT02975557|"~     The objective of this study is to establish whether patients with dry eye disease (DED) are~     able to tolerate receiving Brimonidine: 0.15% eye drops two times a day for twelve weeks~     (primary tolerability objective) and to investigate the preliminary efficacy of Brimonidine~     0.15% topical eye drop solution in treating MGD (primary efficacy objective).~      Meibomian Gland dysfunction can happen with numerous conditions such as Rosacea, Sjögren's~     syndrome, and oGVHD. In order to limit the influence of differing etiologies on the outcome~     of this trial, the investigator has limited the screening to MGD that accompanies oGVHD.~   "
45175|NCT02975544|"~     The purpose of this study was to evaluate whether an intervention based on the social and~     emotional competence development improves the healthy lifestyles adoption in young children.~   "
45176|NCT02975531|"~     Parameterize the Pompage technique with an anatomical model cervical region to simulate~     specific procedures. Quantify the times, displacements, and facilitate the training of~     students and professional of physical therapy.~   "
45177|NCT02975518|"~     We plan to track the migratory behaviour of culture-expanded enothelial outgrowth cells in~     the context of vascular injury sustained during elective coronary angiography.~      We will use Flouro-deoxyglucose-labelling and PET-CT to track the endothelial cells.~   "
45178|NCT02975505|"~     The transition from chronic kidney disease (CKD) to end-stage renal disease ESRD is a~     vulnerable and challenging period of time for patients and providers. Suboptimal control of~     blood pressure is known to be common in patients with the advanced stages of CKD, and may~     contribute to their elevated risk of progression to ESRD, cardiovascular morbidity, and~     mortality. This proposal is a pilot randomized controlled trial designed to test whether~     intensive blood pressure lowering is feasible and safe in patients with advanced CKD as they~     transition to ESRD.~   "
45179|NCT02975492|"~     Recommendations for vitamin D supplementation for children between 2 and 6 years offer strong~     sequential doses of vitamin D: 2 times 100 000 units in spaced winter period of 3 months.~     Data from the literature show a further increase in the incidence of oxalo-calcium stones in~     children and adolescents associated with hypercalciuria with training Randall plates,~     essential step lithogenesis calcium oxalate. Knowing the links between vitamin D and urinary~     calcium excretion, these data lead to the question of increased sensitivity in some children~     with vitamin D, sensitivity could explain these situations with hypercalciuria increase the~     gallstone risk. This increased sensitivity to vitamin D may unmask particularly if inputs of~     high doses of vitamin responsible then a transient hypercalciuria with development of~     microcrystals.~   "
45180|NCT02975479|"~     The study evaluates the safety and effect of intralymphatic allergen specific immunotherapy~     in increasing doses. Patients with allergy to grass or birch will be treated with three~     intralymphatic injections in an up-dosing protocol; 1000 SQ-U, 3000 SQ-U and 10 000 SQ-U, or~     placebo.~      ***IMPORTANT INFORMATION!*** The up-dosing protocol is changed due to adverse events at 5000~     SQ-U. One patient had general utricaria 15 minutes after injection (moderate reaction). One~     patient had a serious adverse event with anaphylactic reaction 6 minutes after intralymphatic~     injection. (1000 SQ-U and 3000 SQ-U have been given with no serious adverse events.) New~     regimen: 1000 SQ-U, 3000 SQ-U, 3000 SQ-U.~   "
45186|NCT02975401|"~     The purpose of this study is the measurement of the evolution of the operation time during~     the start-up phase of robotic-assisted surgery for the treatment of inguinal hernia`s of 50~     patients treated in Maria Middelares in laparoscopic rTAPP technique.~   "
45189|NCT02975362|"~     The objective of this proposed study is to determine whether acupuncture combined with~     rehabilitation treatment could improve significantly motor function in ischemic stroke~     patients. In this 8-week, assessor-blind, a Multi-center randomized, controlled study of~     acupuncture as additional treatment with the rehabilitation treatment, a total of 240~     patients with stroke patients will be recruited. The patients will be randomly assigned to~     acupuncture combined with rehabilitation treatment (n =120) or rehabilitation treatment (n~     =120). (40 sessions, 5 sessions a week). Changes in the motor function over time are measured~     using Fugl-Meyer Scale and Modified Barthel Index. Change in the stroke syndromes over time~     are measured using stroke syndrome of TCM Scale. Change in the quality of life over time are~     measured using SS-QOL scale. The study will be conducted at Shanghai University of~     Traditional Chinese Medicine, Long Hua Hospital, Fudan University, Hua Shan Hospital.~   "
45190|NCT02975349|"~     The aim of this protocol is to find out about the safety and effectiveness of M2951 in~     patients with relapsing multiple sclerosis. Patients will be placed into 1 of 3 groups to~     receive M2951, placebo or tecfidera for 24 weeks. After 24 weeks, the patients on placebo~     will be given M2951.~   "
45191|NCT02975336|"~     M2951 is an investigational drug under evaluation for treatment of autoimmune and~     inflammatory disorders. The purpose of the study is to assess the Safety and Efficacy of~     M2951 in Subjects with Systemic Lupus Erythematosus (SLE)~   "
45192|NCT02975323|"~     Portal hypertension is the result of an increased hepatic vascular resistance and portal~     inflow. The best established method to assess portal pressures is the determination of wedged~     hepatic venous pressure gradient (HVPG). Ultrasound Doppler technique is non-invasive in the~     assessment of portal hypertension as compared with invasive technique of measurement of the~     hepatic venous pressure gradient (HVPG). Hemodynamic measurements (BP and pulse recording)~     will be done and then patient will be given tablet Carvedilol 12.5 mg in a single dose and~     wait till the time that 20% reduction in heart rate from the baseline occurs. Haemodynamic~     measurements will be repeated to assess the acute response to beta-adrenoreceptor blocker~     agent. The change in the HWF will be recorded post beta-adrenoreceptor blocker~     administration.~   "
45193|NCT02975310|"~     Chronic rhinosinusitis, also called chronic sinusitis, is a very common life-long disease~     affecting over 5% of the Canadian population. Its symptoms, including daily facial pain and~     headache, an inability to breath through the nose and complete smell loss, regularly impair~     one's ability to work and to enjoy and participate in daily activities. The annual cost of~     chronic sinusitis to Canada is estimated at $1.3 billion while the government pays an~     estimated $860 million yearly for chronic sinusitis treatment. Chronic sinusitis with polyps,~     the most common type of chronic sinusitis, is usually treated with a combination of~     medications and surgery. Until now, surgical treatment has only been performed in the~     operating room, at a cost of about $3500 per procedure. But, recent studies have shown that a~     new procedure, in-clinic polyp removal, can provide an improvement in patient symptoms to~     levels equal to those for sinus surgery performed in a hospital operating room. Moreover, in~     clinic polyp removal has additional advantages including a shorter procedure recovery time, a~     significantly lower cost to the health care system (about one-tenth the cost or $450), and a~     shorter wait time for treatment. With the proposed pragmatic trial, the investigators will~     determine whether the in clinic polyp removal procedure is as good as sinus surgery in the~     operating room at controlling patient symptoms of chronic sinusitis. The investigators will~     also determine the cost and health-benefits for a patient, the healthcare system and for~     society of in clinic polyp removal in comparison to sinus surgery done in a hospital~     operating room. The investigators will then know if this new treatment, in clinic polyp~     removal, can replace sinus surgery as the standard of care for these patients.~   "
45194|NCT02975297|"~     The purpose of this study is to identify a potential new treatment for smoking cessation.~   "
45195|NCT02975284|"~     This study evaluates the longterm clinical outcomes, including safety and efficacy parameters~     after Bronchial Thermoplasty (BT) treatment over a period of 5 years. All patients included~     in de TASMA trial in the Netherlands will be asked to participate in the TASMA extension~     study.~   "
45196|NCT02975271|"~     Study of the Efficacy, Safety & Tolerability of Serlopitant for Pruritus (Itch) After Burn~     Injury~   "
45197|NCT02975258|"~     The goals of this study are to 1) examine the relationships among inflammation, obesity, and~     asthma in people with HIV and 2) to test if special subtypes of cells or markers are present~     in the blood and lungs of people with HIV with asthma compared to those without asthma.~   "
45198|NCT02975245|"~     This study will determine the short-term effects of chemotherapy on sperm DNA.The study~     involves the collection of semen sample through ejaculation prior to initiation of~     chemotherapy and up to three time points after initiation of chemotherapy.~   "
45199|NCT02975232|"~     Through research, education and extension, this project will promote fruit and vegetable~     (F&V) purchases and consumption by families in under-resourced communities, thus reducing~     health disparities, improving human nutrition, and preventing unhealthy weight gain among~     children. Specifically, this project aims to evaluate the success of promoting F&V purchases~     among low- income and Supplemental Nutrition Assistance Program (SNAP)-eligible families and~     children living in a rural Maine community through a double value coupon, supermarket- based~     incentive program combined with Cooking Matters at the Store education. Education and~     extension efforts based on the study findings will contribute to meeting USDA Childhood~     Obesity Prevention Challenge Area Goals of generating new knowledge; developing, assessing~     and expanding effective interventions; and increasing the number of skilled and informed~     professionals and consumers to address the complex problem of childhood obesity. The research~     team will partner with a large national retail grocery chain (Hannaford Brothers), Cooking~     Matters, University of Maine Cooperative Extension, eXtension Communities of Practice, Maine~     SNAP-Ed, and The Food Trust to accomplish the project objectives.~   "
45200|NCT02975219|"~     Incomplete resection of endometriosis lesions often results in recurrence of symptoms and the~     need for repeated surgery, with considerable associated morbidity. The aim of this pilot~     project is to determine the feasibility of fluorescence imaging to improve the treatment of~     endometriosis in the future.~   "
45201|NCT02975206|"~     Study of the Efficacy, Safety, and Tolerability of Serlopitant for Pruritus (Itch) in Atopic~     Dermatitis~   "
45202|NCT02975193|"~     Cognitive impairment in Parkinson's disease (PD) has far-reaching effects on both motor~     outcomes and quality of life in PD patients. Furthermore, deep brain stimulation (DBS), now~     an evidence-based treatment for certain cases of PD, has the risk of causing deficits in~     multiple areas of cognition.~      As such, the purpose of this study is to understand the neuroanatomical and neurophysiologic~     basis for impaired cognition in PD. The aim is to identify neural correlates of cognition by~     measuring brain signal activity while PD patients are engaged in cognition on a computer.~   "
45203|NCT02975180|"~     Every year about 1 out of every 1,600-5,000 infants has a stroke around the time of birth.~     Many of these children will have lifelong physical problems. For example, the arm muscles are~     often paralyzed. This makes every day activities, like reaching and grasping objects, very~     difficult. To date there are few effective treatments for the paralyzed arm of young children~     with stroke. The main objective of this study is to test whether a new kind of treatment,~     known as functional electrical stimulation (FES), is able to improve arm function in children~     with stroke. FES involves applying electrical currents to weak or paralyzed muscles. This~     enables movements, such as reaching and grasping, which can then be practiced. The~     investigators will compare the effectiveness of FES treatment to standard arm rehabilitation~     in children aged 3-6 years who had a stroke early in life. They will measure the~     effectiveness using a number of clinical measures of arm function. Other objectives of this~     project are to test how well children adhere to the treatment schedule, and to evaluate~     parent and child satisfaction with FES treatment.~   "
45204|NCT02975167|"~     Labor induction is one of the most common obstetric procedures performed in the U.S. In 2012,~     the last year for which data is available, 23.7% of all deliveries were the result of~     inductions. Labor induction first requires cervical ripening, which can be accomplished by~     several different methods. Vaginal or oral prostaglandins, extra amniotic saline infusion,~     osmotic dilators and transcervical Foley catheters are all widely used instruments for~     pre-induction cervical ripening. The ideal cervical ripening tool is safe for both mother and~     fetus, incurs low cost, does not require extensive monitoring, and causes minimal maternal~     discomfort. The Foley catheter has been found to be both safe and effective, but little is~     known about patient satisfaction with the device in an in-patient and out-patient setting.~     The proposed study will investigate patient satisfaction in a randomized controlled trial of~     in-patient versus out-patient use of Foley catheters.~   "
45205|NCT02975154|"~     This study evaluates the effect of Microcurrent Therapy in the treatment of osteoarthritis of~     the knee. Patients will be randomized to four groups: Group 1 and 2 both will receive~     Microcurrent Therapy, but different currents will be used. Group 3 will receive treatment~     with the Microcurrent treatment apparatus, but without any current. Group 4 will be a control~     group without specific interventions.~   "
45206|NCT02975141|"~     This study sets out to determine the maximum tolerated dose (MTD) of afatinib in combination~     with gemcitabine/nab-paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma.~     The identified MTD will serve as recommended phase II dose (RP2D).~   "
45207|NCT02975128|"~     This study will assess whether it is feasible to remove small breast cancers completely using~     the Breast Lesion Excision System under Ultrasound guidance.~   "
45208|NCT02975115|"~     This study is designed to confirm the efficacy of dasatinib 100mg once daily in producing a~     complete molecular response and to prove a possibility of Operational Cure in CMR patients.~   "
45209|NCT02975102|"~     The primary objectives of this investigation are to show that the performance of CBL-101 Eye~     Drops is non-inferior to that of Vismed® Multi eye drops in subjects with moderate to severe~     keratoconjunctivitis sicca after 28 days, and to assess the safety of CBL-101 Eye Drops~     during a 90-day period with treatment administered 3 to 6 times per day.~   "
45210|NCT02975089|"~     The proportion of the elderly population has increased rapidly worldwide. Frailty is a common~     geriatric syndrome. Comprehensive dietary management strategy may have beneficial effects on~     frailty prevention and reversal. We compared the effects between micronutrients and/or~     protein supplement, and balanced diet on frailty status in elderly individuals who were at~     either pre-frail or frail stage. A total of 37 subjects completed a 3-month paralleled,~     single-blind, randomized control trial on (1) multiple nutrients supplementations, (2)~     multiple nutrients plus isolated soy protein supplementation, and (3) individualized~     nutrition education with designed dishware for balanced diet as well as food supplementations~     (mixed nuts and milk powder). Intervention effects on dietary intakes, biomarkers, frailty~     score and geriatric depression score (GDS) were assessed. The nutrition education~     intervention with designed dishware and milk powder/nuts supplement significantly increased~     the intake of vegetables, dairy, and nuts, along with increased concentration of urinary urea~     nitrogen of the pre-frail/frail elders. It yielded a significant reduction in frailty score~     (p<0.05) and a borderline decrease (p=0.063) in GDS-SF. Our study indicated that the dietary~     approach with easy-to-comprehend dishware and food supplements to optimize the distribution~     of multiple dietary components showed its potential to improve not only frail status but also~     psychological condition in elderly.~   "
45211|NCT02975076|"~     Agents of sanchi have been widely used as a complementary medicine for stroke in China.~     Sanchitongshu is a new Chinese patent medicine extracted from sanchi which has stronger~     anti-platelet activity than other agents of sanchi. The investigators's aim was to~     investigate the synergistic action of aspirin combined with sanchitongshu capsule in the~     treatment of patients with minor ischemic stroke and transient ischemic attack.~   "
45212|NCT02975063|"~     Investigators will use a cluster-randomized design to evaluate the overall impact of the~     Alive & Thrive infant and young child feeding communication strategies in Lagos and Kaduna~     States, Nigeria. The impact in a subset of urban local government areas (LGAs) will also be~     tested.This is a mixed methods evaluation; the quantitative data will be complemented by~     qualitative data obtained from different groups targeted by or involved in the program.~   "
45213|NCT02975050|"~     This study has the following objective:~      • To validate the capability of the μ-Cor System to monitor ECG, Heart Rate (HR), Respiration~     Rate (RR), Posture and Activity in healthy human subjects.~      The μ-Cor validation will be demonstrated at two body locations:~        1. Side location (below left armpit) for study arm 1, and~        2. Front location (upper left chest) for study arm 2 An FDA-cleared comparator device will~          be used to support the validation of the study device.~   "
45217|NCT02974998|"~     This two-arm cluster randomized trial is testing a gender-focused comprehensive HIV testing~     and counselling (HTC) program, the Young Women's Health CoOp (YWHC) with a standard HTC~     program and will target female adolescents (aged 16-19) who use substances and have dropped~     out of school. To evaluate the process, the study will examine the feasibility of using peer~     role models as recruiters and co-facilitators of the intervention and monitor fidelity to the~     intervention. Efficacy of the intervention on behavioral and biological outcomes, and on~     linkages to health services, through follow-up visits conducted 6- and 12-months~     post-enrollment will be also assessed.~   "
45218|NCT02974985|"~     Hyaluronic acid (HA) fillers are tested in-vitro to measure their lifting capacity,~     viscosity, cohesivity, and rheologic properties, and their lifting capacity has been tested~     in animal models. To date, there are no studies that measure the lifting capacity of fillers~     in an in-vivo human model.~      The intention is to study the lifting capacity of fillers in a group of patients by comparing~     pre and post-procedure two and three-dimensional photographs using analytic software.~     Specifically, the PI is interested in determining the amount of tissue elevation created by~     injecting HAs Restylane-Lyft®, and Restylane-L® (Galderma Laboratories, L.P., Fort Worth, TX)~     to the midface and to the lower face, both in the anterior-posterior direction and in the~     vertical direction by using analytic software.~      The research group has identified a reliable and reproducible quantitative assessment of~     midfacial position called WIZDOM (Width of the InterZygomatic Distance Of the Midface) to~     quantitatively evaluate the midface. It can be used as an objective tool to assess midfacial~     rejuvenation, whether with fat, fillers, or midface or facelift surgery. The Distance from~     WIZDOM to inner canthus, the WIZDOM -IC measurement increases with aging as the face deflates~     and descends, and, in the practice, is also a means of assessing the midface in youth and in~     aging. The PI's findings have been published in the Aesthetic Surgery Journal. The practice~     will also attempt to utilize this metric as a measure of midface aesthetic lifting capacity.~      The practice will also employ 3 D photography and analytic software to determine degree of~     lift in mm in the y and z axis. (vertical and AP increase in dimension) pre and post-~     injection. (Vectra, Canfield, Fairfield, NJ)~      We will recruit patients from a population of subjects that generally would receive fillers~     to improve changes associated with facial volume loss and divide them in to two groups based~     on chronologic age.~   "
45219|NCT02974972|"~     In this study, the investigators conducted research among HIV-infected and -uninfected~     pregnant and lactating women to understand the potential role and importance of food~     insecurity on participant physical and psychosocial health and nutrition.~   "
45220|NCT02974959|"~     The purpose of this single-center, prospective, randomized (1:1), double-blind,~     sham-controlled parallel-arm pilot study is to provide initial evidence of use of the~     noninvasive vagus nerve stimulator for treatment in patients recovering from concussion and~     moderate traumatic brain injury to improve clinical recovery. The study compares the safety~     and effectiveness of an active gammaCore treatment against a sham treatment.~   "
45221|NCT02974946|"~     This is a prospective randomised control trial 1:1 in patients at risk of developing Acute~     Kidney Injury after cardiac surgery comparing the RenalGuard® System to current medical~     treatment. 110 patients will be recruited for each group. The aim of the study is to assess~     whether the RenalGuard® system reduces Acute Kidney Injury (AKI) after cardiac surgery as~     compared to current practice.~   "
45222|NCT02974933|"~     The purpose of this study is to evaluate the efficacy of apatinib mesylate combined with~     pemetrexed alone in advanced non-small cell lung cancer patients in the second or second line~     of treatment of progression-free survival~   "
45223|NCT02974920|"~     Aortic valve replacement with a biological prosthesis is the most common valve surgery~     performed with about 1000 operations performed in Denmark each year. Further, the~     introduction of percutaneous stent valves will increase these types of replacements in the~     years to come. A biological valve is a foreign body prone to cause thrombus formation at~     least until the valve is covered with recipient endothelium. There are no conclusive studies~     of anticoagulation and the investigators have shown stroke to be a common complication.~     Guidelines have variably recommended aspirin or rivaroxaban for anticoagulation, and~     currently aspirin is the most common recommendation. In a register study, the investigators~     have shown that proper anticoagulation with warfarin is likely to be superior. There is a~     clear need for a large randomised study of aspirin versus anticoagulation for biological~     aortic valve replacement. This protocol describes a randomised study where 1000 patients will~     be randomised to receive either rivaroxaban or aspirin for 6 months following aortic valve~     replacement with a biological prosthesis. The primary efficacy endpoint is a combined event~     of all-cause mortality and hospitalisation for either acute myocardial infarction or stroke.~     This study has the power to settle a discussion of appropriate anticoagulation for this~     operation~   "
45224|NCT02974907|"~     The objective of this study is to compare the safety and efficacy of RGN-259 Ophthalmic~     Solutions to placebo for the treatment of the signs and symptoms of dry eye.~   "
45225|NCT02974894|"~     In the present study the main goal has been to clarify the effect of the probiotic bacteria~     Lactobacillus plantarum 299v on the salivary cortisol level in young adults under examination~     stress. Salivary IgA from minor glands and in whole human saliva was measured as alternative~     marker of stress. The hypothesis was that the levels of cortisol would be reduced or~     stabilized in the test group in comparison to the placebo group where the cortisol levels~     were expected to increase due to the examination-induced stress. By contrast, the salivary~     IgA levels were expected to increase in the test group in comparison to the placebo group.~   "
45226|NCT02974881|"~     Multicenter feasibility study of the HighLife™ TMVR system.~   "
45227|NCT02974868|"~     This is a Phase 2a, randomized, double blind, parallel group, multicenter study with an~     extension period. The study will have a maximum duration of approximately 85 weeks. This~     includes an up to 5 weeks screening period, a 24 week treatment period, a 4 week drug~     holiday, an up to 12 month extension period, and a 4 week follow up period. The study will~     enroll a total of approximately 132 subjects. The study will be conducted at approximately 30~     to 40 sites.~   "
45228|NCT02974855|"~     This study is designed to evaluate the safety, tolerability, pharmacokinetics,~     pharmacodynamics and efficacy of multiple subcutaneous and/or intravenous doses of~     PF-06741086 in subjects with severe hemophilia.~   "
45229|NCT02974842|"~     This study evaluates the ability of the MAKO 7 device to collect various cells~   "
45230|NCT02974829|"~     The purpose of this study is to conduct an investigator initiated observational study to~     continue to follow up the China subset of study participants for another 5 years after they~     complete participation in the REALM Study~   "
45231|NCT02974816|"~     The purpose of this study is to compare HbA1c of insulin-treated subjects with type 2~     diabetes managed via usual care alone and usual care augmented with remote monitoring using~     Glooko~   "
45232|NCT02974803|"~     Dabrafenib and trametinib are drugs that are usually given for the treatment of melanoma.~     Combinations of dabrafenib and trametinib have also been studied and when used together have~     shown to increase tumour shrinkage in animals compared to either drug alone. Dabrafenib and~     trametinib have also shown potential to penetrate the blood-brain-barrier when given together~     and have an effect on brain metastases. Giving these drugs at the same time and then giving~     brain stereotactic radiosurgery (SRS) may also be preferred in patients with brain metastases~   "
45233|NCT02974790|"~     After a basic training to echocardiography, emergency physicians will have to answer simple~     clinical questions about circulatory failure mechanisms. The objective of the study is to~     assess the agreement between these answers and those of the expert physician in patients~     admitted in the emergency department with a circulatory failure due to sepsis or not.~     Emergency physicians will volunteer to take part in a basic training on echocardiography. The~     training will include 4 hours of theory, 2 hours of interactive clinical cases and 6 hours of~     tutored practice at patients' bedside (10 to 15 examinations). The objective of the practice~     sessions will be to learn the technical grounds of transthoracic echocardiography (TTE), the~     different views and to identify the anatomical structures. The second part of the study will~     start after the training. Each eligible patient will be successively assessed by two~     investigators: one emergency physician recently trained and the expert physician. The~     echocardiography will be performed as soon as possible in the emergency department before or~     after the initiation of treatment without delaying it. The order of hemodynamic assessments~     will be random depending on the availability of the investigators; both assessments will~     however be performed within 30 minutes. Each investigator will independently read the~     echocardiography in real time at patients' bedside. They will then answer a limited list of~     standardized questions using two-choice answers or predefined choices. Finally investigators~     will choose a therapeutic proposition among a predefined list based on the answers. Only the~     results of the echocardiography performed by the expert physician will be used in patient~     management.~   "
45234|NCT02974777|"~     The purpose of this study is to determine the efficacy and safety of a routine individualized~     antiplatelet therapy after coronary stent implantation by evaluating on-treatment platelet~     reactivity with Multiple Electrode Aggregometry (MEA, Multiplate® Analyzer).~      IDEAL-PCI Extended is the continuation of the IDEAL-PCI registry with additional focus on~     bleeding events and net clinical benefit~   "
45235|NCT02974764|"~     Pancreatic adenocarcinoma (PDAC) is the fourth leading cause of cancer mortality in the~     United States. The high mortality for these tumors is primarily attributed to the late stage~     in which most patients are diagnosed, leading to a dismal 5-year survival of 6% for all~     stages of PDAC. Surgical resection offers the best chance for survival, but most patients~     only present with symptoms after the tumor has metastasized, and as a result are not~     operative candidates. This creates a need to both identify patients at an earlier stage while~     their cancer is still resectable, and predict the aggressiveness of the disease in order to~     better target treatment. In addition, even patients who receive curative surgery are at a~     high risk of developing recurrence of disease. Thus, there is also a need to detect~     recurrence early so appropriate treatment can be provided. As several adjuvant~     chemotherapeutic regimens are now available, it will be important to identify as soon as~     possible that the cancer has become refractory to a given therapy. This will allow one to~     progress to second or third line therapy more quickly while the tumor burden is smaller. This~     purpose of this study is to identify biomarkers in the blood of patients with PDAC and~     determine how they can change over time in relation to treatment to assess for any~     correlation with patient outcomes, response to treatment, recurrence of disease and overall~     survival. This study will be limited to patients who present to the Johns Hopkins Hospital~     between January 1, 2015 and December 31, 2018 with PDAC. Blood will be drawn from all~     consenting patients at the time of initial diagnosis and after treatment. Patients will~     undergo treatment for their cancer based on personal preference, standard guidelines and~     discussion with medical, radiation, and surgical oncologists. Patients who undergo surgical~     resection will also have an additional blood sample collected after resection, and patients~     who undergo chemotherapy and/or radiation will have an additional blood sample draw at the~     end of this treatment. A patient could have blood collected at multiple intervals, i.e. a~     pre-treatment sample, sample post-neoadjuvant chemotherapy/radiation, sample post-surgery,~     and sample post-adjuvant chemotherapy/radiation. In patients, who have undergone curative~     resection of PDAC blood samples will be collected till they develop clinical recurrence of~     disease. For the first 2 years following surgery samples will be collected every 3-4 months.~     Beyond that the investigators will collect samples every 6 months for the next two years. For~     all patients found to be alive and disease free beyond 4 years after surgery samples will be~     collected once every year. These patients will be followed to determine disease-free and~     overall survival. With this study, the investigators aim to assess the potential utility of~     blood biomarkers over time for pancreatic tumors which will help both with early detection of~     disease and also recurrence of disease after surgery. Biomarkers identified would have the~     potential to create a new method for early diagnosis of patients with PDAC, predict overall~     survival, response to treatment, or risk of metastatic spread, and predict recurrence of~     disease, all of which has the potential to drastically improve outcomes for this deadly~     disease.~   "
45236|NCT02974751|"~     The purpose of this study is to evaluate the efficacy of the AQUABEAM System for the~     treatment of Lower Urinary Tract Symptoms (LUTS) resulting from Benign Prostatic Hyperplasia~     (BPH).~   "
45237|NCT02974738|"~     The primary objective of this study is to identify the maximum tolerated dose (MTD) of PT2977~     Tablets and/or the recommended Phase 2 dose (RP2D) of PT2977 Tablets in patients with~     advanced solid tumors~   "
45238|NCT02974725|"~     To characterize safety and tolerability and identify a recommended dose and regimen for the~     LXH254 and LTT462 combination and for the LXH254 and trametinib combination.~   "
45239|NCT02974712|"~     This study aims to investigate the effects of different methods of administration on~     emergence period after laryngeal mask anesthesia in elderly patients undergoing transurethral~     endoscopic operation~   "
45240|NCT02974699|"~     There is currently a critical gap in knowledge of how intestinal bacterial communities alter~     metabolic substrates available to the host thereby influencing central and enteric nervous~     system (CNS/ENS) neurotransmitter levels involved in regulating carbohydrate consumption in~     humans. Understanding these relationships is essential for developing strategies to improve~     blood glucose control and to reduce the risk of transitioning from prediabetes to type-2~     diabetes (T2D). The investigators' long-term goal is to determine the biological~     underpinnings of behaviors that impact food intake and blood glucose control that contribute~     to the development of T2D. The objective of this proposal, which is an essential next step in~     attaining the investigators' long-term goals, is to determine how bacterial populations in~     the digestive system impact circulating tryptophan (TRP) and large neutral amino acid (LNAA)~     levels that regulate production of monoamine 5-hydroxytryptamine (5-HT, serotonin) in the ENS~     and in gastrointestinal system and the brain. The central hypothesis is that a reduced ratio~     of TRP producing (TRPp) to TRP consuming (TRPc) bacteria (decreased TRPp:TRPc ratio) in the~     gut will decrease TRP availability following a carbohydrate meal lowering the plasma TRP:LNAA~     ratio and resulting in less TRP for ENS/CNS production of 5HT. Further, dietary interventions~     that promote TRPp bacterial abundance within the gut will increase TRP availability to the~     host. The investigators will test the central hypothesis and, thereby, accomplish the overall~     objective for this project by pursuing the following specific aims: 1) Assess impact of~     divergent microbiota on plasma TRP:LNAA ratio in response to acute carbohydrate consumption,~     and 2) Assess the impact of dietary supplementation with resistant starch (RS) on gut~     microbiota and circulating TRP:LNAA ratio. During Aim 1, stool samples will be collected from~     healthy participants. Participants will be stratified based on gut TRPp:TRPc ratio and the~     response to an acute meal will be assessed by determining plasma TRP:LNAA ratios. During Aim~     2 the capacity for 4-weeks of pre-biotic RS (Potato Starch) supplementation to increase the~     TRPp:TRPc bacterial ratio in the gut will be determined from stool samples. Additionally,~     plasma TRP:LNAA ratio following acute carbohydrate consumption before and after~     supplementation will be determined. The scientific contribution will be to determine the~     impact of RS on TRPp and TRPc bacteria abundance in the gut, and how bacterial populations~     impact circulating TRP:LNAA levels, that can impact ENS and CNS 5HT production in humans.~     This contribution will be significant because it will have direct translational implications~     for human diseases with altered 5HT signaling.~   "
45241|NCT02974686|"~     Patients who receive renal transplantation at BJH are placed on triple maintenance~     immunosuppression, which means that patients take 3 types of immunosuppression drugs to~     suppress their immune system including tacrolimus, mycophenolate (MPA), and prednisone.~     However, due to the effects of MPA on the gastrointestinal tract, patients often complain of~     GI adverse effects. Current practice is to either dose-reduce MPA or convert the patient to~     an alternative agent, typically Azathioprine. Both of these strategies have limitations,~     largely due to concerns related to efficacy. Everolimus (EVR) has demonstrated similar~     efficacy to MPA in renal transplantation and may offer a benefit related to GI adverse~     effects, so the investigators will convert patients to EVR in this study. Patients who are~     within their first year post-transplant will be converted to EVR upon enrollment in the~     study, and serial measurements ,or a series of measurements looking for an increase or~     decrease over time, of GI adverse effects will be conducted over 1 year post-enrollment.~   "
45242|NCT02974673|"~     The objective of this research is to study the sphincter activity during ejaculation in~     patients with spinal cord injury in order to detect an ejaculatory dyssynergia. For this~     purpose, using a catheter the protocol plans to measure the sphincter pressures during~     ejaculation. Moreover, cardiovascular parameters will be measured continuously during the~     ejaculatory test.~   "
45243|NCT02974660|"~     Transcatheter aortic valve implantation (TAVI) is a new, rapidly emerging standard of care in~     inoperable and high-risk patients with severe, symptomatic aortic stenosis. Information~     regarding reversal of unfractionated heparin with protamine sulfate in order to facilitate~     access site closure is scarce and based on expert consensus. Clinical practice varies between~     centers. Protamine sulphate may decrease the amount of bleeding complications related to the~     access-site. The impact on possible thromboembolic complications is unknown. Both bleeding~     and thromboembolic complications increase mortality after TAVI. A randomized trial is~     required in order to assess impact of protamine sulfate on prevalence and extent of bleeding~     and thromboembolic complications.~   "
45244|NCT02974647|"~     The purpose of this study is to test any good and bad effects of the study drug called~     ruxolitinib. Ruxolitinib works by blocking a protein called JAK. JAK works along with another~     protein called STAT and is important for survival of many T or NK-cell lymphomas. By blocking~     JAK, ruxolitinib may cause T or NK-cell lymphomas to shrink.~   "
45245|NCT02974634|"~     The purpose of this study is to test the benefits of an educational program, the Ostomy~     Self-Management Training (OSMT) program, for improving patient activation (preparedness to do~     self-care), self-efficacy (patients' ability to do self-care), knowledge of ostomy/urostomy~     self-care, quality of life, mood, use of medical services, and financial burden in patients~     with ostomies. The study will compare patients in the intervention (training) group and~     patients in the usual care group.~      Subjects' participation in this study is expected to last about 7 months. The PI plans to~     enroll up to 176 subjects at 3 hospitals (University of Pennsylvania, Yale University School~     of Nursing, and City of Hope in Los Angeles). All patient telehealth education will be~     coordinated by the University of Arizona in Tucson, Arizona.~   "
45246|NCT02974621|"~     This randomized phase II trial studies how well cediranib maleate and olaparib work compared~     to bevacizumab in treating patients with glioblastoma that has come back. Cediranib maleate~     and olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of~     tumor cells to grow and spread.~   "
45247|NCT02974608|"~     Background:~      Malaria is a serious disease. It is passed by infected mosquitoes. In many parts of Africa,~     malaria continues to be the main cause of death in young children and pregnant women.~     Researchers want to find out more about how malaria affects pregnant women and their babies.~      Objectives:~      To study the rate of miscarriage and stillbirth during the second and third trimesters among~     women in a certain district in Mali. To study rates of malaria infection over time among~     pregnant women and children in this area.~      Eligibility:~      Pregnant women of any age and pregnancy stage and their newborns. They must live in~     Ouelessebougou, Mali. Children up to 10 years old who live there.~      Design:~      Information about the study will be shared at community meetings, during visits to the health~     centers, and during census updates.~      Participants will read and sign a consent form.~      Pregnant women will be screened to see if they are eligible. They may have a urine test. They~     may have an ultrasound to date their pregnancy. Ultrasound uses sound waves to take pictures~     of the body.~      Women will be enrolled in the study after they have their babies.~      Participants may have a physical exam.~      Some participants will provide a finger/heel prick blood sample.~      Participants will complete a questionnaire. They will be asked about:~      Medical history~      Antimalarial and other interventions~      Socioeconomic status~      Their pregnancy~      Previous pregnancies~      Health of their newborn...~   "
45248|NCT02974595|"~     Background:~      Some diseases cause chronic inflammation with intermittent flares in the body. These are~     called autoinflammatory diseases. They can cause fevers, rashes, ulcers, and other problems.~     Researchers want to learn more about the causes and effects of these diseases. They hope this~     will improve how the disease is managed in the future.~      Objectives:~      To understand the underlying immune dysregulation~      To identify the genetic cause~      To translate our findings into novel treatments that improve patients disease outcomes~      Eligibility:~      Patients with known NOMID/CAPS, DIRA, CANDLE, SAVI, NLRC4-MAS, Still's Disease, and with~     other yet undifferentiated autoinflammatory diseases.~      Unaffected relatives of participants with a known or undifferentiated autoinflammatory~     disease~      Healthy adult volunteers at least 18 years of age~      Design:~      Participants will be screened with blood sample and medical history. They may provide copies~     of their medical records.~      Enrolled participants will be evaluated at the NIH for 2-5 days. All participants will have a~     detailed medical history, physical exam, blood tests, and other evaluations depending on the~     extent of their autoinflammatory disease.~      Participants may also expect the following assessments:~        1. Clinical tests that help assess organ damage and function such as hearing, vision,~          memory, and learning tests.~        2. Imaging studies to characterize organ involvement of the inflammatory disease including:~          X-rays, CT scans, special MRIs, and bone scans.~        3. Laboratory evaluations including clinical markers of disease activity, research samples~          for genetic studies, blood samples for cytokine/biomarker assessment, and gene~          expression profiling.~        4. Questionnaires to assess disease activity and quality of life.~        5. If indicated, other procedures may be administered that include: a lumbar puncture if~          CNS inflammation is suspected, a skin biopsy if skin inflammation is present, and/or~          gastrointestinal and pulmonary procedures if they are clinically indicated.~      Participants may return for a single follow-up visit or for long-term follow-up visits~     depending on their disease and willingness to return. Long-term follow-up may occur for up to~     15 years on this protocol.~   "
45954|NCT02965352|"~     This study has developed a peripheral to quantify the functional strength of children without~     motor change during the movement of grip and pinch. It was possible to know the exact values~     of these strengths, the range of motion that was made, and also if the grip strength was~     maintained during all the arc of motion.~   "
45249|NCT02974582|"~     Background:~      Smoking is a major public health problem in the U.S. Almost a half a million Americans die~     from it in a year. One thing that contributes to why people smoke is the marketing of~     cigarettes. Cigarette direct mail marketing usually targets young smokers of lower~     socioeconomic status. Researchers want to find out more about how this kind of marketing~     influences smoking behavior in young people from different socioeconomic levels.~      Objectives:~      To study the effects of cigarette direct mail marketing on beliefs, responses, and arousal.~     To study how these things may differ among young adult smokers of high and low socioeconomic~     status.~      Eligibility:~      Healthy adults ages 18 to 29 who smoke.~      Design:~      Participants will have 1 visit.~      Participants will be asked questions about their health and recent smoking.~      A nurse will check their vital signs.~      Participants will have a simple eye exam.~      They will give blood and urine samples.~      Participants will be connected to equipment. This will collect data while they look at~     pictures.~      Then they will have a 10-minute break. A nurse will observe them during the break.~      Participants will have their breath analyzed.~      Participants will answer questions. The topics will include:~      Education~      Job~      Income~      Family history~      Tobacco use~      Exposure to pro-smoking and anti-smoking messages~      History of drug and alcohol use~   "
45250|NCT02974569|"~     This study evaluates the use of the Computerized Symptom Capture Tool (C-SCAT), which creates~     an image of the symptoms the participant is experiencing, for improving symptom~     self-management in adolescents and young adults with cancer. In this one-group trial,~     participants will complete the C-SCAT and use it during two clinic visits with their oncology~     providers.~   "
45251|NCT02974556|"~     This study aims to determine the oncological effectiveness, compared to standard surgical~     treatment, of proactive management including target organs for peritoneal spread resection~     (omentectomy, bilateral adnexectomy, appendectomy, hepatic round ligament resection) and~     preventive HIPEC (intraperitoneal oxaliplatin with concomitant i.v.~     5-fluorouracil/leucovorin) following a curative resection of high-risk ( >/= 5 mm tumor~     invasion beyond the muscularis propria) T3 and T4 colon cancer in preventing the development~     of peritoneal metastases. Adjuvant systemic chemotherapy will be reserved in both groups for~     patients with poor prognostic factors according to Folinic acid/Fluorouracil/Oxaliplatin~     (FOLFOX) or to Capecitabine/Oxaliplatin (CAPOX) regimens.~      Hypothesis:~      The hypothesis is that compared to the standard treatment proactive management following~     curative resection of high-risk T3 and T4 colon cancer will reduce the development of~     endoperitoneal metastases~   "
45252|NCT02974543|"~     The purpose of this study is to develop and test a subject operated device to lessen tinnitus~     (ringing in the ear), based on subject-feedback for stimulus presentation.~   "
45253|NCT02974530|"~     The oropharyngeal junction participates in 3 interpenetrating functions: Swallowing,~     Breathing and Speech. In the context of ischemic or hemorrhagic stroke, these are altered,~     isolated or associated manner, causing major disorders and representing a source of handicap~     for patients.~      Understanding the swallowing mechanisms is therefore a major challenge to guide the~     rehabilitation and improve the initial and long-term prognosis of patients with stroke.~      The main objective of this study is to describe and modeling, thanks to a clinical,~     physiological and radiological knowledge base, swallowing, speech and breathing, in patients~     with stroke and in healthy subjects.~   "
45254|NCT02974517|"~     Nowadays, the rapid development of human assisted reproductive technology (ART) has provided~     many help for couples with fertility issues. Even take baby home rate has been increased~     dramatically in the past several decades; both clinicians and embryologists are still~     struggling to improve pregnancy rates. Among all the strategies that the embryologists have~     tried, much work has been done to find better embryo culture conditions and embryo quality~     evaluation system. Currently, most centers in the world, including ours, are still using~     conventional incubators and manual embryo scoring system. This traditional method has several~     limitations, such as unstable environment during culture, and embryo scores can be different~     judged by different embryologists. EmbryoScope® by Vitrolife is a newly developed time-lapse~     embryo culture and analysis system. It is user-friendly, and suited for routinely daily use.~     In addition, its KID Score system can help embryologist select high quality embryos quickly,~     which leads to an overall increase in pregnancy outcome in IVF/ICSI cycles. The aim of this~     prospective cohort study is to evaluate the use of EmbryoScope® in our center.~   "
45255|NCT02974504|"~     A multi-center, randomized, double-blind, active-controlled, parallel group, phase IV~     clinical trial to investigate the effect on blood glucose of evogliptin after oral~     administration in patients with type 2 diabetes~   "
45256|NCT02974491|"~     The investigators hypothesized that acute consumption of Fuji apple juice (AJ) could increase~     the antioxidant status and/or decrease the oxidative stress (OS) biomarkers, without~     increasing serum biochemical parameters in patients undergoing maintenance hemodialysis~     (MHD). In this pre-post pilot feasibility study, patients served as their own controls,~     received 300 and 150 mL AJ immediately after a dialysis section, on different days, with a 3~     week-washout period. Blood was collected at the baseline period, after 30 and 60 min of AJ~     consumption. OS biomarkers (total antioxidant status (TAS), total oxidant status (TOS),~     ascorbic acid, catalase (CAT), glutathione peroxidase (Gpx), superoxide dismutase (SOD) and~     reduced glutathione (GSH) and potassium, phosphorus, uric acid, and glucose concentrations~     were analyzed.~   "
45257|NCT02974478|"~     Aim of the study is to investigate the impact of orange juice consumption (with meals or~     between meals) as well as sugar sweetened beverage (SSB) consumption (between meals) on~     glucose homeostasis and antioxidative status.~   "
45258|NCT02974465|"~     The aim of this study was to assess the effect of a specific protocol of sEMG-BFB in upper~     limb hemiparesis added to conventional physical therapy on changes in upper extremity~     functionality, motor recruitment pattern and range of motion (ROM) compared to the single~     application of conventional physical therapy. It aims to find a 22.22% difference between~     both interventions.~   "
45313|NCT02973750|"~     While significant progress has been made in the treatment and prognosis of ovarian cancer,~     this progress has mostly shown benefits for younger women.~      This study aims to understand two things: How body composition (the amount of muscle and~     water versus fat in in the body) affects the dose and side effects of chemotherapy; and the~     biological reason for the worse prognosis with aging. To get a good view of these effects,~     investigators are asking the help of both younger and older women for this project.~   "
45259|NCT02974452|"~     A cross-sectional descriptive study, in which the surface electromyographic activity of five~     shoulder muscles was compared in three populations: older adults, middle-aged adults and~     young adults. The evaluation of the electromyographic data offers a suitable foundation to~     understand aging process.~      This supports that surface electromyography provide information about the aged shoulder~     muscles. Loss of functionality is suffered by a high percentage of older adults, which~     greatly limits their physical activity. In this sense, this paper presents findings that~     might be related with possible therapeutic approaches in subsequent studies.~   "
45260|NCT02974439|"~     This study evaluates the pharmacokinetics and bioequivalence of Amlodipine Besylate Tablets 5~     mg versus Norvasc 5 mg tablets administered as 5 mg tablet in healthy volunteers with a~     washout period of 14 days~   "
45261|NCT02974426|"~     Rationale: Completely resected non-small cell lung cancer (NSCLC) patients with~     histologically confirmed N2 disease are a heterogeneous population. After complete resection~     and postoperative chemotherapy (POCT), 20%-40% of cases have a risk of locoregional~     recurrence (LRR). Postoperative radiation therapy (PORT) should be an integral component of~     the multidisciplinary treatment for patients with stage IIIA(N2) disease. Postoperative~     Radiotherapy (PORT)-first strategy may have an advantage of the early administration of~     locoregional therapy to the mediastinum, in which the tumor burden is presumed to be higher~     than that of systematic micrometastases. It is not yet known for subsets with specific~     prognostic factors that confer higher LRR risks, what is the optimal timing of PORT and how~     to integrate with POCT (in a sequential fashion or concurrent fashion) when PORT is~     considered for patients with completely resected stage IIIA(N2) NSCLC.~      Purpose: This randomized phase III trial is studying the optimal timing of PORT to evaluate~     whether the PORT-first strategy (PORT administered first with concurrent or subsequent POCT)~     may be more effective than the PORT-last strategy (PORT administered sequentially following~     POCT) in treating high risk of LRR patients with completely resected pathologic stage~     IIIA(N2) NSCLC.~   "
45262|NCT02974413|"~     This research project has the main objective to analyze the benefits of self-care supported~     for adult men with Diabetes Mellitus. Treat yourself will randomized-controlled clinical~     study, randomized cluster to be developed with men aged between 40 and 70 years who have type~     2 diabetes and are registered with the Health Strategy teams of the Municipality of Family~     Maringa. The recruited subjects will be randomly allocated into two groups: intervention~     group and control group. In the first, individuals will participate in a self-care~     intervention supported by a nurse, based on supported self-care and behavior change protocol;~     and second, individuals participate in conversation circles and will have the assistance~     normally provided by health services. The follow-up will take place for six months and will~     be collected information: socioeconomic, demographic, behavioral health, complications,~     laboratory and anthropometric. It is intended, through this study, demonstrate the~     effectiveness of this type of intervention, user-centric, on the health of men with DM,~     reinforcing this option of choice for professionals and users within the Primary Health Care~     (PHC).~   "
45263|NCT02974400|"~     Schizophrenia is a severe mental disorder which is accompanied by an enormous individual and~     societal burden. Despite established efficacy of cognitive behavioral therapy for psychosis~     (CBTp), its dissemination into routine mental health care remains poor. National regulations~     such as the National Institute for Health and Care Excellence (NICE) guideline in the United~     Kingdom recommend that CBTp should be offered to every person with psychotic symptoms, but~     more than 50% do not receive even a single session of CBTp. In Germany, CBTp is virtually not~     represented in the psychotherapy health service. Internet-based cognitive behavioral therapy~     (CBT) in a self-help format has been proven feasible and effective in anxiety and depressive~     disorders. Recently, Internet-based (self-help) interventions are also deployed via~     smartphone apps. The feasibility of Internet-based treatments for people with schizophrenia~     is well documented for Internet-based interventions (e.g., medication management) and also~     reported for smartphone interventions. However, there is a dearth of empirical studies~     precluding a conclusive picture. As far as the investigators know, there is only one study~     encompassing 90 participants with psychosis that investigated an Internet-based intervention~     with symptom-specific, cognitive behavioral interventions, which is from the investigators'~     research group. The unique features of the proposed project are 1) the first-time evaluation~     of a symptom-oriented, CBTp-based self-help treatment for people with psychotic symptoms via~     Internet, enhanced with smartphone assistance. The study is set up as randomized controlled~     trial (RCT) with active treatment versus a wait-list control group. It evaluates a combined~     Internet-based guided self-help treatment for persecutory ideation and auditory verbal~     hallucinations. The active treatment condition consists of access to a self-help website~     including regular written electronic contact with a guide and access to smartphone-based~     interactive worksheets (apps). The trials combine the low-threshold advantages of an online~     approach (e.g., anonymity) with the virtues of a clinical trial (e.g., symptom assessment and~     diagnostic verification via Interview). The primary outcome measure is the Positive and~     Negative Syndrome Scale (PANSS). Secondary outcome measures include self-reported symptom~     measures (Paranoia Checklist; Beliefs About Voices Questionnaire revised), completion rates,~     drop-out from the intervention, general symptomatology, side-effects, and client~     satisfaction. The project will help to answer the empirical question whether CBTp-based~     interventions in a purely Internet-based self-help format are effective. Positive findings~     would pave the way for an easy-to-access treatment option for patients with psychotic~     symptoms who currently are deprived of psychotherapeutic treatment.~   "
45264|NCT02974387|"~     STUDY OBJECTIVE: To evaluate and compare the safety and efficacy of (corneal Wound Healing~     and Intraocular Pressure) Fluorometholone and Loteprednol after photorefractive keratectomy~     (PRK) surgery.~      OVERALL STUDY DESIGN: Structure: Single-center, randomized, single blinded, contralateral~     (one eye receives FML, one eye Lotemax) Treatment Group: Patients will be randomized to the~     eye and will receive FML in one eye, Lotemax in contralateral eye Duration: 3 months~     Dosage/Dose Regimen: All patients will receive each one of the steroid agents 4 x a day for~     one month, 3 x a day for one month and 2 x a day for one month Study medication will be~     administered to the randomized eye through post op days according to mention protocol. Visit~     Schedule: baseline-screening, postop days 1, 7, 30 and then month 3th (through corneal~     re-epithelialization).~   "
45265|NCT02974374|"~     The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of a~     single dose of PF-06835919 in healthy adult subjects.~   "
45266|NCT02974361|"~     This study is to help development of a new version of Ibuprofen, called Ibuprofen-LDH.~     Ibuprofen-LDH will be used as a treatment for muscular pains, headache, fever etc. This new~     version of ibuprofen is expected to produce fewer stomach/intestine related side effects when~     compared to many existing marketed formulations of Ibuprofen.~      This study is split into 3 parts. Part A is a 7 way crossover, Part B is a maximum of a 6 way~     crossover and Part C is a maximum of a 4 way crossover. The size of Parts B & Part C and~     allocated interventions will be confirmed after review of data from Parts A and/or B~     respectively.~      A total of 30 subjects will take part in the study; 10 per study part.~      The key objective is to assess the pharmacokinetics properties of Ibuprofen-LDH, with and~     without a selection of different excipients. The pharmacokinetic properties will include how~     quickly the drug is absorbed into the bloodstream and also the maximum concentration of drug~     that reaches the bloodstream.~   "
45267|NCT02974348|"~     The antimalarial drugs efficacy and safety study will be conducted in the Clinics and~     hospital of the Cameroon Development Corporation (CDC) Estates, Tiko Health District, located~     in a typical forest and rainfall area in the South West Region Cameroon. In this study, 350~     children aged 6 months to 5 years who are found to have uncomplicated symptomatic malaria~     will be enrolled between October 2012 and March 2013. Participants will be randomized to~     receive one of the following medications.~      (i) DHA+PQ : dihydroartemisinin, 2.5 mg per kg, plus piperaquine phosphate, 20mg per kg daily~     for 3 days; (ii) ART LUM : Artemether, 2mg per kg, plus lumefantrine 10mg, twice daily for 3~     days; (iii) AS+MQ: artesunate, 4 mg/kg/day, with mefloquine, 8 mg/kg/day orally once a day~     for 3 days.~      All study medications will be administered orally The Primary objective of this study are to~     compare the efficacy, safety and tolerability of orally administered artemether plus~     lumefantrine (ART+LUM), artesunate plus mefloquine (AS+MQ) and dihydroartemisinin plus~     piperaquine (DHA+PQ) combinations in the treatment of uncomplicated falciparum malaria in~     Cameroon in order to provide evidence that can be used to determining the optimum antimalaria~     treatment policy in Cameroon. The secondary objectives are as follows (i) To valuate the~     efficacy and safety of artemether plus lumefantrine (ART + LUM) and artesunate plus~     mefloquine (AS + MQ) versus dihydroartemisinin plus piperaquine (DHA + PQ) combination (ii)~     To compare the clearance of asexual parasites and gametocytes in each treatment arm (iii) To~     assess the clearance of fever (iv) Assess effect of each treatment arm on anemia This study~     is a randomized, double blinded clinical trial. After enrollment, participant will be~     randomized to one of the three treatment regimen. The treatment outcome will be assessed~     through a 42-day efficacy study. Participants who will exhibit early or late treatment~     failure and those with adequate clinical response and parasitological failure on day 14, 28~     or 42 will be treated with quinine (25mg base per kg body weight per day in three divided~     doses for five days). In addition to antimalarial drugs oral paracetamol (50mg/kg body weight~     per day in three divided doses) will be administered for fever exceeding 37.5%. Polymerase~     Chain Reaction (PCR) -corrected 28 day and 42 day efficacy will be evaluated for each~     treatment episode.~   "
45268|NCT02974335|"~     This is a 4-phase study to implement the NIDA CDEs in primary care settings. Collecting and~     utilizing the CDEs in clinical practice requires a strategy for implementing screening to~     collect substance use information that populates the CDEs, and assisting primary care~     providers to offer appropriate interventions by providing clinical decision support (CDS) and~     a mechanism for making referrals to addiction treatment. We aim to maximize the efficient~     adoption of screening, CDS, and treatment referrals by integrating all of these activities~     into the electronic health record (EHR).~      The study will be conducted at three sites, representing three large health systems. Each~     phase will include deliverables essential to move to the next phase, and an independent~     Advisory Committee will review progress and make recommendations at each transition about how~     best to progress to each subsequent phase. Based on progress during earlier phases, the~     Advisory Committee may recommend expansion to additional clinics or health systems during the~     second part of Phase 4.~   "
45269|NCT02974322|"~     The purpose of study is to test the effect of an experimental medication GED-0301(mongersen)~     and evaluate its safety in patients (≥ 12 years of age) with active Crohn's disease. The~     study will test GED-0301 compare to placebo for 12 weeks. The study treatment is blinded~     which means that patients and the study doctor will not know which treatment has been~     assigned. Patients in this study will be allowed treatment with stable doses of oral~     aminosalicylates, oral corticosteroids, immunosupressants and antibiotics for the treatment~     of Crohn's disease. Adolescent patients will also be allowed treatment with stable doses of~     exclusive enteral nutrition and growth hormone.~      All patients who complete the study will have the option to enter a long term active~     treatment study.~   "
45270|NCT02974309|"~     A three month randomized study to examine the potential benefits of sleep extension in tandem~     with clinical trial on diabetes management in youth with type 1 diabetes.~   "
45271|NCT02974296|"~     The goal of this project is to guide rTMS using fMRI in individuals with depression who did~     not respond to standard TMS treatment to evaluate whether targeted TMS using individualized~     functional MRI scans produce outcome superior to that of conventional approaches. The study~     team also plans to scan patients with Major Depression Disorder (MDD) patients prescribed to~     receive standard TMS for the first time before and after which they will have resting-state~     Functional Magnetic Resonance Imaging (rs-FMRI) scan in order to see if we can predict their~     responsiveness based on the functional connectivity maps.~   "
45272|NCT02974283|"~     The purpose of this study is to find out a serum marker for the evaluation of blood brain~     barrier damage based on animal experiments and investigate the effect of NBO（Normobaric~     hyperoxia）on blood brain barrier in the acute ischemic stroke patients who received r-tPA~     thrombolytic therapy.~   "
45273|NCT02974270|"~     Analysis of body mass index in Central Precocious Puberty patients treated with leuprolide~     acetate~   "
45274|NCT02974257|"~     This study is to evaluate whether thiamine can increase oxygen consumption and lower lactate~     in patients who initially survive an in-hospital cardiac arrest. Patients who are~     successfully resuscitated after an in-hospital cardiac arrest and who are on mechanical~     ventilation in the intensive care unit will be enrolled, and will get either thiamine or~     placebo. Their oxygen consumption and lactate will be measured at serial time points and~     compared between groups. The investigators' hypothesis is that thiamine will help restore the~     body's ability to metabolize oxygen normally (aerobic metabolism), leading to an increase in~     oxygen consumption and a decrease in lactate.~   "
45275|NCT02974244|"~     Exenatide once weekly (Bydureon) was approved in January 2012 by FDA in USA for the treatment~     of type 2 diabetes mellitus. Evidence from clinical trials suggested that Bydureon improves~     glucose control with low risk of hypoglycemia. Bydureon does not require a dose titration as~     necessary for other glucagon-like peptide-1 agonists, and appears to have other advantages,~     such as reducing insulin resistance, reducing weight, and improving blood pressure and lipid~     profiles. However, the degree to which these advantages of Bydureon lead to improve outcomes~     in customary clinical care is unknown.~      The aim of this study is to evaluate the effectiveness and tolerability of Bydureon relative~     to basal insulin initiated as first-ever injectable therapeutic regimens used in customary~     clinical care. Patients who initiated treatment with Bydureon or basal insulin between July~     2011 and March 2015 will be recruited into the study cohorts from Optum's database of~     electronic health records. The two treatment cohorts will be matched by propensity score~     method.Clinical outcomes of HbA1c, weight, and gastrointestinal symptoms and hypoglycemia are~     investigated.~   "
45276|NCT02974231|"~     The objective is to report outcomes,including grade ≥2 overall late rectal and urinary~     toxicity and biochemical control rates in patients treated with IMRT (70 gy, 74 Gy and 80 Gy)~   "
45763|NCT02967861|"~     The objective of the study was to evaluate the levels of Peroxisome proliferator-activated~     receptor gamma (PPAR-γ), Nuclear factor-kappa B (NF-kB) and the presence of red complex~     microorganisms (RCM) such as Treponema denticola (T.d), Porphyromonas gingivalis (P.g) and~     Tannerella forsythia (T.f) in the subgingival tissues of chronic periodontitis subjects~     before and after intervention with pranayama as an adjunct to scaling and root planing.~   "
45277|NCT02974218|"~     The Cliniques Universitaires Saint Luc are one of the high specialized center in valvular~     heart diseases and valvular heart surgery. Aortic stenosis, mitral and aortic regurgitation~     are the three valve pathology that are mainly frequent and studied.~      International guidelines in the management of valvular heart diseases are based on few~     limited old studies, mainly retrospective. And, a matter of concern is staying, about the~     timiong of surgery for asymptomatic patients.~      A prospective registry will help us to better understand the pathologies and try to better~     define guidelines criteria for surgery.~   "
45278|NCT02974205|"~     The posterior cruciate ligament injuries (PCL) is rare and rehabilitation methods are~     varying. The purpose of the study is to explore if one rehabilitation option is preferable to~     one other for patients with acute PCL injury, by examining whether there will be differences~     in laxity in the knee joints and patient-reported knee function by three different~     rehabilitation protocols. A randomized controlled trial with 75 patients enrolled will be~     followed up 3 and 12 months after injury. The groups will be compared using kneelaxity~     (stress - X) and subjective knee function (KOOS, IKDC-2000)~   "
45279|NCT02974192|"~     Ischemic stroke accounts for the majority of stroke cases and constitutes a major cause of~     death and disability in industrial world. Inflammation has been reported to constitute a~     major component of ischemic stroke pathology. The brain responds to ischemic injury with an~     acute andprolonged inflammatory process. Few studies have investigated the relationship~     between acute biomarkers of inflammation and functional outcome following stroke~   "
45280|NCT02974179|"~     Subjects from the AG-CLI-0206 phase 3 study that received AMG0001 will be eligible for the~     AG-CLI-0206-LTFU study~   "
45281|NCT02974166|"~     The purpose of this study is to determine whether osteopathic manipulative treatment~     associated to Dentistry care and speech therapy improves pain and function in individuals~     with temporomandibular disorders.~   "
45282|NCT02974153|"~     The purpose of this study is to assess the efficacy and safety of ALD403 in the prevention of~     migraine headache in chronic migraineurs.~   "
45283|NCT02974140|"~     The purpose of this study is to compare the refractive predictability (prediction error)~     between the Cataract Refractive Suite (CRS) and standard manual technique at one month~     post-operative~   "
45284|NCT02974127|"~     This is a prospective observational trial consisting of robotic multisession radiosurgery~     (CyberKnife ®) for large and medium size and/or located at critical site benign intracranial~     meningiomas.~   "
45285|NCT02974114|"~     This parallel, assessor blind, placebo-controlled, stratified, randomized study will~     investigate the effects of everyday pain on cognition and mobility in otherwise healthy~     individuals.~   "
45286|NCT02974101|"~     This is a prospective, multi-center, correlation study in which the investigators aim to~     explore the relationship between subjective pain questionnaires and the AdaptiveStim~     accelerometer output.~   "
45287|NCT02974088|"~     This was a Phase IIa randomised, assessor blinded, parallel group study in which half the~     participants were treated with Nice 'n Clear neem-based conditioning lotion plus combing with~     a head louse detection and removal comb and the remainder were treated with Nice 'n Clear~     plus combing with a normal grooming comb~   "
45288|NCT02974075|"~     Despite continuous technical improvements in urologic surgery, up to 40% of prostate cancer~     patients will develop biochemical recurrence after radical prostatectomy (RP), potentially~     because of micro metastasis at the time of the primary surgery.~      With improved radiological modalities and nuclear medicine tracers like 68Ga-PSMA PET/CT,~     which allow the localization of the site of recurrence, there is increasing interest in~     metastasis directed therapies, such as salvage lymph node dissection.~      The pelvic extended salvage lymph node dissection (sLND) is a promising option for treating~     prostate cancer patients with local recurrence after radical prostatectomy with curative~     intent. Several retrospective series has been published to determine the local value of sLND.~     Despite the first data seem to be feasible and promising, to date no prospective evaluation~     has been made. Thus sLND is still experimental according to the guidelines and is considered~     as an off label therapy.~      This prospective single center phase I/II study was conducted to investigate the safety and~     early efficacy of salvage lymph node dissection in prostate cancer patients with local pelvic~     recurrence after radical prostatectomy (RP) with curative intention.~   "
45289|NCT02974062|"~     The purposes of this study were to 1) determine test-retest reliability of an iPhone~     application measurement and protocol, 2) establish minimal detectable change of an iPhone~     application measurement and protocol, and 3) determine the immediate effect of core~     stabilization exercise on trunk proprioception in healthy individuals.~   "
45290|NCT02974049|"~     The recommended treatment for elimination of LF in sub-Saharan Africa is annual mass drug~     administration (MDA) with single dose Albendazole (ALB) plus Ivermectin (IVM) given for at~     least 5-7 years. However, in areas where LF is co-endemic with a related filarial parasite,~     Loa loa, co-infection with L. loa represents a serious barrier to LF elimination because IVM~     used in LF MDA can result in severe reactions and even death in individuals with high~     microfilaria (mf) levels of L. loa. Screening for heavy L. loa infection is problematic. To~     overcome this problem, monotherapy with ALB is possible, since this drug has little or no~     effect on circulating mf and thus would not cause adverse effects in people with heavy L. loa~     infections. Moreover ALB has been shown to have embryostatic or embryocidal effects in female~     adult worms resulting in decreased mf levels with time as natural attrition of circulating mf~     occurs. Thus this open-label, randomized clinical trial will examine treatment with ALB~     monotherapy administered twice per year over a period of 3 years with the primary endpoint~     being the proportion of individuals with total clearance of mf at 36 months and Alere antigen~     test negativity (a more sensitive circulating antigen test of filarial infection). Two of the~     treatment arms will include ALB at two different doses, 400mg or 800mg (fixed dose twice~     yearly) as compared to standard treatment of ALB (400 mg) plus IVM (150-200 µg/kg)~     administered annually. Observations from an ongoing clinical trial in Papua New Guinea~     suggest that a single dose of triple therapy with ALB + IVM + DEC may be highly effective in~     sterilizing adult female worms. Therefore to confirm and expand these important preliminary~     observations in a different population, a fourth arm will be included in the current clinical~     trial in which subjects will receive all three drugs. The clinical trial will be performed in~     a region of Cote d'Ivoire where onchocerciasis and loiasis are not endemic.~   "
45338|NCT02973425|"~     Take a Break (TAB) is a randomized trial designed to evaluate NRT-sampling and a mHealth~     suite of apps. TAB is a time-limited self-efficacy and skills building experience for~     Motivation Phase smokers. TAB is designed to create a timeline within which motivation~     smokers will be encouraged to try a brief period of abstinence. Smokers in this Motivation~     Phase are relatively untapped in research available information. This project offers these~     smokers point-of-need technology support in the many components of the intervention.~   "
45291|NCT02974036|"~     The overall purpose is to study quality in patient education by means of the patients'~     self-rated enablement. Specific aims are:~      To assess the validity of the patient enablement instrument in relation to self-efficacy and~     empowerment; To investigate if patient enablement can be effective in identifying which~     patients would benefit the most from patient education; To study if patient enablement has~     any relation to self-efficacy, function or self-rated health; To analyze if patient~     enablement has a causal effect on health care consumption; To evaluate whether patient~     education is a cost-effective intervention. The project is a longitudinal study, including~     patients from a patient education programme for osteoarthritis in primary health care. Data~     consist of patient reported outcome measures and health care consumption. Cost-effectiveness~     and cost-utility analysis will be used. Inclusion of patients will start August 2016.~     Analyses of data and manuscript writing will be performed in 2018-2019. Researchers included~     are from primary health care settings and researchers in the field of OA, patient education~     and health economy. Our increasingly older and more inactive population will raise huge~     demands on the health care. The importance of optimizing treatments that are available in~     primary health care cannot be underestimated. The project will contribute with important~     knowledge about the patient's own process of getting well.~   "
45292|NCT02974023|"~     The current study was designed to evaluate the effectiveness and safety of the device in the~     common areas of the body affected by different causes of musculoskeletal pain in Vietnamese~     population in real life situation.~   "
45293|NCT02974010|"~     NeuroRx is developing NRX-101, a fixed-dose combination oral capsule composed of~     d-cycloserine (DCS) and lurasidone for the maintenance of remission from Acute Suicidal~     Ideation (C-SSRS level 4 or 5) and Behavior (ASIB) in adults with Bipolar Depression~     following initial stabilization. Patients with Bipolar Depression and ASIB will be recruited~     in both inpatient and outpatient settings and, following informed consent, will be given an~     intravenous infusion of ketamine 0.5mg/kg over 40 minutes. Those who exhibit a satisfactory~     clinical response to ketamine will be randomly allocated to NRX-101 or to a comparator group.~     The primary outcome variable is time to relapse as defined by a return to baseline in either~     depression or suicidality as determined by the treating physician or the need to institute a~     new treatment plan.~   "
45294|NCT02973997|"~     This phase II trial studies how well pembrolizumab and lenvatinib work in treating patients~     with differentiated thyroid cancer that has spread to other places in the body or has come~     back and cannot be removed by surgery. Monoclonal antibodies, such as pembrolizumab, may~     stimulate the immune system to attack the cancer, and kinase inhibitors, such as lenvatinib,~     may interfere with the ability of tumor cells to grow and spread.~   "
45295|NCT02973984|"~     Preliminary data suggest that:~        1. a different risk of mortality, as assessed by the Multidimensional Prognostic Indices~          (MPI), may influence the anticoagulant prescription in older subjects with Atrial~          Fibrillation (AF);~        2. the presence of multidimensional impairment, disability and multi-morbidities are~          usually not included in the decision algorithm of the more appropriate treatments in~          older patients with AF;~        3. considering the prognostic information, as calculated by the MPI, can be useful to~          physicians in identifying older patients with AF that can benefit from anticoagulant~          treatment in term of increased survival.~   "
45296|NCT02973971|"~     The present single center clinical chronobiological study on 24 subjects (12 patients with~     mild to moderate form of Alzheimer's disease and 12 Healthy subjects) aims at characterizing~     the ADDIA biomarkers: a) blood cell‐based biomarkers measured by flow cytometry using~     proprietary probes specific of two targeted biomarkers, beta‐Amyloid (Aβ) peptide and a~     kinase, and b) circulating biomarkers in peripheral body fluids. The biomarkers will be~     analyzed on samples taken at different time points of the day, including under fasting and~     non-fasting conditions and at two periods: day 1 and day 14.~   "
45297|NCT02973958|"~     Circumcision is the most common surgical procedure performed by Pediatric Urologists.~     Ketorolac has been shown to have an efficacy similar to morphine in multi-modal analgesic~     regimens without the commonly associated adverse effects. This study aims to see if giving~     ketorolac during the operation will result in better pain control. We hypothesize that~     ketorolac will result in pain control similar to morphine with a lower incidence of side~     effects such as nausea and vomiting.~   "
45298|NCT02973945|"~     The aim of this study is to compare exercise capacity in Chronic Obstructive Pulmonary~     Disease (COPD) patients before and after an 8 week pulmonary rehabilitation program.~      Patients will be randomised in two groups, one arm will received oxygen through High Flow~     Nasal Cannula (HFNC) and the other group by The Venturi Mask (VM)~   "
45299|NCT02973932|"~     Internet-based psychotherapy for children and adolescents with obsessive-compulsive symptoms~     and an age of 7 to 17 years. Sessions are verified with teleconferencing with an~     psychotherapist, children and their parents. The psychotherapy is supported by an App and a~     wristband to obtain psychophysiological data.~   "
45300|NCT02973919|"~     The goal of this study is to increase the efficiency of exposure in virtual reality (VR).~      Based on the EMDR research the investigators would like to show that the implementation of~     eye movements during the VR exposure results in a faster physiological relaxation response~     among probands with spider phobia, which has a positive effect on the subjective and~     behavioral efficacy of the VR exposure.~   "
45301|NCT02973906|"~     The overarching goal of this study is to advance research on family-based prevention of~     negative child outcomes for reintegrating Operation Enduring Freedom/Operation Iraqi Freedom~     personnel by evaluating different formats of a parenting program, After Deployment, Adaptive~     Parenting Tools (ADAPT). The ADAPT program is based upon the Parent Management~     Training-Oregon Model/PMTO, but adapted for military deployed families. The PI will examine~     which of three delivery formats of ADAPT is most effective at reducing youth risk behaviors~     associated with negative childhood outcomes by improving parenting, child, and parent~     adjustment. There is a clear intent to benefit all subjects in this study (except surveyed~     teachers), including children.~   "
45302|NCT02973893|"~     The purpose of this study is to determine if VF001-DP improves wound healing in chronic~     venous leg ulcers compared to standard care only.~   "
45339|NCT02973412|"~     The aim of this study is to explore the associations between chronotype and glycaemic~     control, cardiometabolic health and other lifestyle factors.~   "
45303|NCT02973880|"~     Cataract is an ophthalmic disease that usually affects the elderly population. Cataract~     surgery with phaco-emulsification is now the most frequently performed intraocular surgical~     procedure in the developed world. However, differences in surgical technique impact the~     severity of surgical trauma and post-operative recovery. The amount of post-operative ocular~     pain and inflammation plays a significant role in the Patient's perception of the surgical~     success.~      Several ophthalmic products have been studied in the management of post-surgery ocular~     inflammation and pain following cataract surgery. Corticosteroids are considered the gold~     standard for the treatment of ocular inflammation, and their most commonly used route of~     administration is the topical instillation as eye drops formulation.~      After topical administration of Dexamethasone, the concentration in the anterior chamber~     increases and declines within hours, necessitating frequent daily instillations of eye drops~     for several weeks. This might be associated with compliance issues, particularly in elderly~     Patients or in individuals with disabilities. A pharmaceutical formulation allowing for a~     less frequent administration could therefore be an attractive alternative.~      NETILDEX™ eye drops solution, containing Netilmicin Sulfate 4.55 mg (3mg/ml) and~     Dexamethasone Disodium Phosphate 1.32 mg (1mg/ml), is already available for Patients. A new~     ophthalmic gel, preservative-free formulation has been developed. This new formulation has~     been tested in pre-clinical animal studies and in a clinical trial. The new formulation~     contains Xanthan gum, a high molecular mass polysaccharide approved by the FDA in 1969 for~     food products. It is used in the product as viscosity enhancer and to give to the product~     pseudo-plastic characteristics and prolonged ocular retention time.~      The purpose of this trial is to show that the administration of a reduced dose of NETILDEX ™~     gel 2 times a day starting on the day of cataract extraction by means of phaco-emulsification~     and administered until 14 days after surgery is sufficient to obtain a non-inferior efficacy~     of the NETILDEX ™ eye drops solution administered 4 times a day for the same period.~   "
45304|NCT02973867|"~     We showed, for the first time, that Z-score increase during obesity was dependent on sex,~     severity of obesity and age but also on the bone site. Although the increase in BMD at~     bearing areas seems to be logically explained by the assumption that mechanical stresses have~     an osteogenic effect on bone tissue, BMD can in no way respond to the concomitant increase in~     BMD at non-load bearing areas such as the radius. These results suggest that changes in~     certain systemic compounds, induced by obesity, may interfere with bone metabolism. Moreover,~     the fact that the BMD or Z score is positively and only correlated with muscle mass and not~     with fat mass confirm that mechanical stresses are not the only factors acting on bone~     tissue.~      Our objectives are to determine the relationship between plasma concentration of myokines,~     adipokines, bone markers and BMD in obese subjects.~   "
45305|NCT02973854|"~     Patients seen at the Center for Endometriosis (including those with or without pain)~     undergoing laser excision surgery for known or suspected endometriosis will be recruited for~     the study.~      Per the PI's standard surgical approach to endometriosis, all areas of abnormal peritoneum~     will be excised (removed).~      After surgical excision has been performed, in order to provide standardized specimens for~     our research, a 3mm punch biopsy will be obtained from the excised peritoneum tissue. The 3~     mm biopsy will be sent for research analysis, and the rest of the excised peritoneum tissue~     will be sent to histology (SSM) for evaluation and classification as having endometriosis or~     not. For each patient in the study, blood will also be collected to look for markers for~     endometriosis.~   "
45306|NCT02973841|"~     A novel device attached to ultrasound probe designed to increase success rate and safety of~     internal jugular vein cannulation.~   "
45307|NCT02973828|"~     In radiotherapy high-tech scans with x-rays (CT scans) are taken before and during treatment~     to locate the tumour and ensure the radiation is hitting the target.~      These x-rays expose patients to additional radiation and the quality of these scans is often~     poor which makes it difficult to distinguish tumour from normal tissue and there may be~     uncertainty in the tumour position due to movement or shrinkage. To allow for these~     uncertainties a large margin around the tumour is also treated, but this means that large~     volumes of normal tissue also receive significant doses of radiation, which can result in~     early and late toxicity.~      MRI (magnetic resonance imaging) is better than CT scanning at being able to tell the~     difference between tumour and normal tissues and does not expose patients to additional~     radiation. A new machine called an MR Linac (or magnetic resonance imaging-guided linear~     accelerator) integrates high quality MRI with a state-of-the-art radiotherapy machine and the~     Institute of Cancer Research (ICR)/The Royal Marsden Hospital (RMH) are currently~     installation a prototype, which will be one of the first in the world. This revolutionary~     technology has the potential to change the way radiotherapy is delivered. We hope the~     improved precision and accuracy in hitting the target will mean reductions in margins around~     tumours and that this will lead to higher cure rates with significantly fewer side effects.~     Studies are required to simulate treatment on the MR Linac before it can be used in routine~     clinical practice and to conduct these studies, we need to obtain MRI scans on volunteers and~     patients who are currently undergoing treatment. This study will involve imaging with MRI in~     healthy volunteers as well as in patient volunteers before and during their standard course~     of radiotherapy to allow us to develop MRI sequences derived on the MR Linac for MR~     Linac-based research focusing on clinical application and establishment into a MR-CT and MR~     only workflow, treatment adaptation and quality assurance.~   "
45308|NCT02973815|"~     The goal of the proposed project is to see if an innovative family-based intervention can~     reduce childhood obesity by actively engaging the whole family in promoting healthy behaviors~     in the home. In addition, the project will also examine how the NU-HOME family intervention~     influences children's dietary intake, availability of healthy and unhealthy foods in the home~     and served at meals and snacks, physical activity as a family, and child screen time (TV,~     game systems). The study will build upon a similar project conducted in an urban area and~     translate the lessons learned and adapt the program for a rural community.~   "
45309|NCT02973802|"~     Phase 1 study to assess the safety and biological activity of ATX-GD-59 in patients with~     Graves Disease not currently treated with anti-thyroid therapy. This will be an open label~     dose titration involving injections on 10 occasions, each two weeks apart. After dosing is~     complete there will be a 12 week follow up period. Blood samples will be drawn throughout the~     study to monitor safety and the body's response to the injections. Thyroid function will be~     measured throughout the trial to monitor Graves disease progression.~   "
45310|NCT02973789|"~     The study is a prospective, randomized controlled phase III trial aimed to test the efficacy~     and safety of TTFields, using the NovoTTF-100L System, concurrent with standard therapies for~     stage 4 NSCLC patients, following progression while on or after platinum based treatment.The~     device is an experimental, portable, battery operated device for chronic administration of~     alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by~     means of surface, insulated electrode arrays.~   "
45311|NCT02973776|"~     Vasoconstriction study with LEO 90100~   "
45312|NCT02973763|"~     Alflutinib Mesylate Tablets is a Epidermal Growth Factor Receptor (EGFR) mutation selective~     Tyrosine Kinase Inhibitor which can efficient suppress the EGFR T790M drug-resistant mutation~     tumor cell in Xenograft mouse model. This study aims at local advanced or metastatic~     non-small cell lung cancer patients with T790M drug-resistant mutation.~   "
45371|NCT02972983|"~     The purpose of our study is to examine the effects of a second antibiotic, daptomycin, in~     combination with a beta lactam antibiotic on treating bloodstream infection caused by~     methicillin-susceptible S. aureus.~   "
45372|NCT02972970|"~     Feasibility study to assess the scan, fit and print process for the Aveera Patient Matched~     CPAP Mask~   "
45314|NCT02973737|"~     Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This~     study is a randomized, multi-center, multinational, double blind, active-controlled, parallel~     design study of the combination of pyrotinib in combination with capecitabine versus placebo~     plus capecitabine in HER2+ MBC patients, who have prior received anthracyclin, taxane and~     trastuzumab.~      Patients will be randomized in a 2:1 ratio to one of the following treatment arms:~      Arm A: pyrotinib (400 mg once daily) + capecitabine (1000 mg/m^2 twice daily) Arm B: placebo~     (400 mg once daily) + capecitabine (1000 mg/m^2 twice daily) Patients will receive either arm~     of therapy until the occurrence of death, disease progression, unacceptable toxicity, or~     other specified withdrawal criterion.~      Patients in control group can be provide pyrotinib treatment when they progressed after the~     placebo plus capecitabine treatment.~   "
45315|NCT02973724|"~     The investigator designed this study to investigate remifentanil effect-site concentration in~     95% of patients (EC95) for preventing cough after laryngomicrosurgery from propofol~     anesthesia.~   "
45316|NCT02973711|"~     This study combines two drugs (ruxolitinib and the tyrosine kinase inhibitor, nilotinib) in~     an attempt to eliminate the CML (Chronic Myeloid Leukemia) stem cell population and thus~     allow for the deepest and most durable response possible in patients with CML in chronic~     phase who have achieved a complete hematologic remission (CHR), complete cytogenetic~     remission (CCyR), and major molecular remission (MMR), but not a complete molecular remission~     (CMR). The study will look at safety and tolerability of ruxolitinib when combined with~     nilotinib in a phase I study and will help establish the MTD (Maximum Tolerated Dose) of~     ruxolitinib when combined with nilotinib. Once the optimal dose of ruxolitinib is established~     in the phase I setting, a phase II evaluation will seek to establish the efficacy of this~     combination.~   "
45317|NCT02973698|"~     Objective: To verify the effectiveness of chin-down posture maneuver in swallowing therapy~     for Parkinson's disease (PD).~   "
45318|NCT02973685|"~     The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion~     chemotherapy (HAIC) compared with transarterial chemoembolization (TACE) in patients with~     large hepatocellular carcinoma staged BCLC A/B.~   "
45319|NCT02973672|"~     This study evaluates the safety and performance of SGM-101, a Carcinoembryonic Antigen~     (CEA)-specific chimeric antibody conjugated with a NIR emitting fluorochrome, for the~     visualization of CEA-expressing cancers during surgery. SGM-101 is injected 2 to 4 days~     before surgery and visualized using an optimized camera system.~   "
45320|NCT02973659|"~     Primary focal hyperhidrosis interferes with daily activities. Limited efficacy, costs, side~     effects and complications are issues of concern for most current therapeutic modalities. In~     this study the invetigators aim to evaluate the efficacy of topical oxybutynin 10% gel in~     treating primary focal hyperhidrosis. 60 patients with primary focal hyperhidrosis will be~     recruited. Topical oxybutynin 10% gel will be assigned to the right or left axilla, palm or~     sole and a placebo compound to the contralateral side for a total of 30 days. The~     Hyperhidrosis Disease Severity Scale (HDSS) and Dermatology Life Quality Index (DLQI)~     questionnaires will be administered before and after treatment, and 2 noninvolved blinded~     physicians will score the results using starch-iodine tests. The participants will grade the~     sweat reduction on both sides and rated their satisfaction.~   "
45321|NCT02973646|"~     The study is to observe the anti-HBV therapeutic effects of peginterferon alfa-2b in chronic~     hepatitis b patients with e antigen positive based on the detection of interferon gene~     mutation (IFNA2 p.Ala120Thr) and interferon receptor (IFNAR2) detection.~   "
45322|NCT02973633|"~     The development of symptomatic heart failure is frequently preceded by a pre-clinical period~     of structural remodeling in the heart. The remodeling process driving this transition,~     however, remains poorly understood. The investigators hypothesize that imaging the diffusion~     of water in the heart with MRI will allow its microstructure to be resolved. The~     investigators further hypothesize that the characterization of microstructural changes in the~     heart will help elucidate the pathogenesis of heart failure and the transition from a~     compensated to a decompensated state. Patients with recent myocardial infarcts and left~     ventricular hypertrophy, who are at risk for the development of heart failure, will be~     enrolled. The participants will undergo serial diffusion tensor MRI (DTI) imaging of the~     heart to characterize changes in myocardial microstructure over time.~   "
45323|NCT02973620|"~     Open label study of levosimendan; planned comparison for effectiveness and safety to historic~     matched case controls from participating sites.~   "
45324|NCT02973607|"~     Chronic kidney disease (CKD) is present in 1 in 7 of the population and confers a high risk~     of cardiovascular disease. The pathophysiology of cardiovascular disease in CKD is poorly~     understood because CKD is always accompanied by confounding factors including the underlying~     disease process (e.g. diabetes mellitus, systemic vasculitis) and the consequences of CKD~     including hypertension, anaemia and inflammation.~      Nephrectomy in kidney donors causes a 30% reduction in renal function providing an ideal~     study population to measure prospectively the effects of reduced kidney function on the~     cardiovascular system.~      The CRIB-Donor study (ClinicalTrials.gov Identifier:NCT01028703) demonstrated adverse effects~     on cardiovascular structure and function at 12 months compared to controls including an~     increase in left ventricular mass. This proposal will measure the changes in cardiovascular~     structure and function, cardiovascular age and biochemical changes at 5 years providing~     information on the long term effects of reduced renal function.~   "
45335|NCT02973464|"~     This study evaluates the safety and availability of oral valganciclovir(VGC) at the does of~     450mg daily begin within 10 days after renal transplantation, and till to Day 100~     posttransplant. Compare to the guidelines for effective antiviral prophylaxis, the~     investigators divide these patients into three groups in random. One third will oral VGC~     450mg daily as mentioned above; one third will oral VGC 900mg daily; and the other one third~     will intravenous GCV 5mg/kg daily within the first 14 days posttransplant, and continue to~     oral GCV 1g 3 times daily till to Day 100 posttransplant; with does adjusted per renal~     function for all agents.~   "
45336|NCT02973451|"~     to compare between Laparoscopic Guided Transversus Abdominis Plane Block and Trocar Site~     Infiltration as postoperative analgesia in Gynecologic Laparoscopic surgery.~   "
45397|NCT02972632|"~     The purpose of this study is to determine the effectiveness of treatment with vortioxetine on~     participant goal achievement after a change in antidepressant medication for the treatment of~     major depressive disorder (MDD).~   "
45325|NCT02973594|"~     Heart failure with reduced left ventricular ejection fraction (HFrEF) is the most common form~     of chronic heart failure in subjects ≤ 75 years of age. Beta-blocker therapy greatly reduces~     mortality and improves ventricular function in HFrEF patients, but 30-40% of patients do not~     show improvement in ventricular function with beta blockade.~      An extensive gene signaling network downstream from the beta1-adrenergic receptor, the~     primary target of beta-blocker therapy is likely important for development and progression~     HFrEF. Pathologic changes in this gene signaling network are only reversed towards normal~     levels when ventricular function improves. One potential mechanism for failure to improve~     ventricular function in HFrEF patients unresponsive to beta blocker therapy is a lack of~     heart rate reduction.~      Ivabradine is an FDA-approved medication believed to have therapeutic benefit in HFrEF~     patients through reduction in heart rate independent of beta-blockade. Ivabradine has been~     shown to reduce the risk of hospitalization for worsening HF in patients with stable,~     symptomatic chronic heart failure with reduced EF (≤ 35%)in sinus rhythm with resting heart~     rate ≥ 70 bpm and who are on maximally tolerated doses of beta blockers or who have a~     contraindication to beta blockers.~      Given the high rate of mortality and hospitalization of HFrEF patients even with current~     therapies, there is a large unmet need for improving HFrEF therapy. The goals of this study~     are to test the hypothesis that heart rate reduction is an important antecedent for~     improvement in ventricular function, and to identify components of the beta1-adrenergic~     receptor gene signaling network responsible for improvement in ventricular function caused by~     heart rate reduction.~   "
45326|NCT02973581|"~     The aim of this randomized trial is to assess the efficacy of SPI-directed analgesia for~     vitreoretinal surgeries (VRS), presence of PONV and oculocardiac reflex (OCR) and compare~     Numerical Rating Scale (NRS) with Surgical Pleth Index (SPI) for monitoring pain perception~     postoperatively.~      Patients received general anaesthesia alone or combined with either preemptive analgesia~     using topical solution of 0,5% proxymetacaine or peribulbar block (0,5% bupivacaine with 2%~     lidokaine) or preemptive intravenous infusion of 1,0 g of metamizol or preemptive intravenous~     infusion of acetaminophen in a doseof 10-15mg/kg of body weight.~   "
45327|NCT02973568|"~     Today, pain is a difficult affordable subject in Spain. There are however 187 units of pain~     care with a consultations rate in emergency center of more than 60%.For example~     OXYCODONE(opioid analgesic)is widely used while it's under used in Spain.~      In the same way MEOPA(Kalinox) is a new approach of pain care daily used as well in France~     (for example in dislocated shoulder pain, or ulceration care...etc) There are lots of studies~     relative to chronic pain but not too much about acute pain in Spain.That's why we want to~     focus our study on evaluation of acute pain treatment and efficacy in french and spanish~     hospital~   "
45328|NCT02973555|"~     Platelet-rich plasma (PRP) may promote the endometrial growth and improve pregnancy outcome~     of patients with thin endometrium undergoing ART treatments.~   "
45329|NCT02973542|"~     Abdominal pain remains the most deleterious symptom for patients with irritable bowel~     syndrome (IBS) and is causing a significant alteration of their quality of life. The visceral~     hypersensitivity seems to be one of the key mechanisms that could explain the abdominal pain~     in these patients. Current treatments, mainly symptomatic, are of limited effectiveness,~     especially in terms of relief of abdominal pain. The study will aim to evaluate the~     effectiveness of ethosuximide on abdominal pain in patients with IBS, its tolerance and its~     impact on patient quality of life, severity of symptoms related to IBS and the use of~     analgesics / antispasmodic / regulators transit.~   "
45330|NCT02973529|"~     Coronary artery disease is often treated by implantation of permanent metallic~     stents.Coronary stents are required in the early healing phase after balloon dilatation but~     constitute a lifelong foreign body. New bioresorbable stents have been developed and are~     believed to improve long-term safety. The purpose of this study is to compare the safety and~     vessel healing after treatment of simple bifurcation lesions with the CE-marked bioresorbable~     stents Absorb and Desolve.~   "
45331|NCT02973516|"~     This study is an exploratory study aiming to collect data about diagnosis efficacy~     (sensitivity and specificity) of P03277 triphasic liver imaging for HCC in subjects with~     suspected small nodules and chronic liver disease. 30 subjects will be included, having HCC~     confirmed or not by previous enhanced CT and/or MRI and before any biopsy for histology~     analysis. The standard of reference for diagnosis will be given by the site according to~     their standard of care and adapted from EASL/EORTC diagnostic criteria (considering previous~     contrast enhanced imaging (CT and/or MRI) and/or biopsy specimen analysis given on-site~     and/or the more recent AFP results available).~   "
45332|NCT02973503|"~     A Phase 3, Global, Multicenter, Open-Label Study to Investigate the Efficacy of~     Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected~     Patients, with non-severe fibrosis~      The primary objectives of this study are as follows:~        -  To evaluate the efficacy of of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks~          in Treatment-Naïve, HCV GT1b-Infected Patients, with non- severe fibrosis as measured by~          the proportion of subjects with sustained viral response 12 weeks after cessation of~          treatment (SVR 12).~        -  To evaluate the safety and tolerability of EBV/GZR treatment~      The secondary objectives of this study are as follows:~        -  To determine the proportion of subjects who attain SVR at 4 and 24 weeks after cessation~          of treatment (SVR4 and SVR24)~        -  To evaluate the proportion of subjects with virologic failure~        -  To evaluate the kinetics of circulating HCV RNA during treatment and after cessation of~          treatment.~        -  To evaluate the emergence of viral resistance to EBV/GZR during treatment and after~          cessation of treatment~   "
45333|NCT02973490|"~     We design the clincal trial to investigate the efficacy of transanal tube drainage in~     colorectal ESD.~   "
45334|NCT02973477|"~     The purpose of this study is to evaluate the effect of dapagliflozin, a FDA approved diabetes~     medication, on measures of nervous system function of the heart in patients with type 2~     diabetes. The investigators will compare the effect of dapagliflozin with an active~     comparator, glimepiride (a different FDA approved diabetes medication) on measures of heart~     rate variability and assess whether dapagliflozin has modulating effects on measures of~     nervous system function of the heart. This is a crossover study design where all participants~     will receive both study medications equally (12-week intervention periods) in a certain~     order.~   "
45340|NCT02973399|"~     SNX-5422 is a prodrug of SNX-2112, a potent, highly selective, small molecule inhibitor of~     the molecular chaperone heat shock protein 90 (HSP90). Hsp90 inhibitors may overcome~     ibrutinib resistance in Mantle cell lymphomas and this study will investigate whether the~     addition of SNX-5422 to an established dose of ibrutinib will provide clinical response in~     subjects who have residual disease, but have not progressed on ibrutinib after 18 months of~     monotherapy, and/or prevents or delays disease progression of subjects with CLL.~   "
45341|NCT02973386|"~     This is a randomized,controlled,prospective phase III clinical trial. The purpose of this~     study is to evaluate acute toxicity and efficacy of concurrent cisplatin chemoradiation with~     or without capecitabine as adjuvant chemotherapy in Local Advanced Nasopharyngeal Carcinoma~     at High Risk of Distant Metastasis.Exploring an Individualized comprehensive treatment plan~     which is reasonable,effective,low toxicity and fitting with Modern radiotherapy techniques~     for Local Advanced Nasopharyngeal Carcinoma at High Risk of Distant Metastasis.~   "
45342|NCT02973373|"~     The purpose of the study is to evaluate the benefit on image quality of MRI of the chest~     performed under high frequency non-invasive ventilation. This technique indeed allows to~     generate an apnea duration of several minutes with acquisitions performed at full~     inspiration. This study will be applied on healthy subjects.~   "
45343|NCT02973360|"~     This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, dose-finding~     study of SC411 in children with sickle cell disease (SCD). The primary objective of the study~     is to evaluate the safety and tolerability of three different doses of SC411 compared to a~     placebo. All patients will undergo eight weeks of oral study treatment and a four-week safety~     follow-up period. Patients will be randomized to one of three dose levels of SC411 or~     placebo.~   "
45344|NCT02973347|"~     Mechanical ventilation has become one of the most important supportive treatment methods to~     save the life of critically ill children over time. Ventilator-associated pneumonia (VAP) is~     a common complication of mechanical ventilation. It is one of the leading causes of~     hospital-acquired infections in the Paediatric Intensive Care Unit (PICU).VAP can aggravate~     patients' condition and have adverse effect on mechanical ventilation. Moreover, VAP is~     associated with significant increased mortality. In those critical ill patients, the~     catabolism increased, the anabolism decreased, which can induce negative nitrogen balance.~     The consensus of optimal nutrition therapy in pediatric critical care in the Asia-Pacific,~     released in 2014, clearly recommended that early enteral nutrition support, which begin~     within 24-48 hours after admitting in PICU, can significantly reduce the prevalence and~     mortality of nosocomial infection. Intermittent enteral feeding and continual enteral feeding~     are the most common methods of enteral nutrition at present. There is no final conclusion~     about the association between enteral nutrition methods and VAP. Thus, the relationship~     between enteral feeding and VAP has long been a controversial issue. There is little clinical~     research on the correlation between enteral nutrition and VAP in children with mechanical~     ventilation, and mostly were observational studies which lacks strong evidence. How to choose~     the appropriate enteral nutrition remains an urgent need in PICU clinical work. Therefore, it~     is necessary for us to analyze the relationship between enteral feeding and VAP in critically~     ill children. This study would perform a two-year research with mechanical ventilated~     patients in PICU of four children hospitals in Shanghai, which aim to determine the~     relationship between different enteral feeding methods and VAP, to collect the baseline~     characteristic data of ventilated children, to analyze the risk factors for VAP in PICU~     patients. The results from our study would contribute to improving the standard of care for~     children undergoing mechanical ventilation, reducing their lung injury and improving~     prognosis.~   "
45345|NCT02973334|"~     This exploratory study aims at investigating the acute effects of artificially sweetened and~     sugar beverage consumption (as compared to water consumption) on acute hemodynamic and~     metabolic stress response.~   "
45346|NCT02973321|"~     Primary Objective:~      The primary objective of this study is to assess the dose-response relationship of SAR425899~     versus placebo in terms of glycemic control as measured by the change in glycosylated~     hemoglobin (HbA1c).~      Secondary Objectives:~        -  To assess the effect of SAR425899 on body weight.~        -  To assess the safety and immunogenicity profile of SAR425899, including assessment of~          the heart rate (HR) change by electrocardiogram (ECG) and Holter monitor.~        -  To assess the proportion of patients achieving predefined HbA1c targets of <7% and <6.5%~          as well as the proportion of patients achieving ≥5% and ≥10% body weight loss.~        -  To assess the effect of once daily dosing of SAR425899 on additional parameters of~          glycemic control and lipid metabolism.~        -  To assess the effect of once daily dosing of SAR425899 on additional pharmacodynamic~          (PD) biomarkers.~        -  To assess the pharmacokinetic (PK) profile and parameters of SAR425899, inter-individual~          and inter-occasion variability in PK parameters using a population PK approach.~   "
45347|NCT02973308|"~     Exercise testing is commonly being used in patients before surgery to test their overall~     fitness. One group it is being used in is patients who have an enlarged blood vessel in their~     stomach. This is known as an abdominal aortic aneurysm. The exercise test used is known as a~     cardiopulmonary exercise test as it looks at both heart and lung function at the same time.~     Whilst this test is commonly used there have been no studies (to date) which have looked at~     how reliable this test is; this means how well the investigators can obtain the same (or very~     similar) results after multiple tests. The investigators would like to test this reliability~     both between patients and the clinicians performing the testing.~   "
45348|NCT02973295|"~     This study evaluates the influence of Silymarin in reducing laboratory, ultrasonographic~     (Fibroscan) and metabolic components of NAFLD. Half of the patients will receive Silymarin~     (Verum) while the other half will receive placebo~   "
45349|NCT02973282|"~     The purpose of this prospective study is to evaluate the efficacy of the ResAppDx software~     application in diagnosis of pneumonia and other respiratory conditions (bronchiolitis,~     asthma/reactive airway disease, croup, upper or lower respiratory tract infections) in~     infants and children. Patient's cough sounds will be recorded using a smartphone and analysed~     using the ResAppDx software. The ResAppDx diagnosis will be compared to radiologic diagnosis~     and/or clinical diagnosis. The ResAppDx diagnosis will not be provided to the clinician or~     patient.~   "
45350|NCT02973269|"~     The specific aim of the study is to compare the safety and efficacy of a single~     administration of DaxibotulinumtoxinA for Injection versus placebo for managing plantar~     fasciitis.~   "
45438|NCT02972099|"~     The objective of the study is to assess the short-term and long-term effects of~     transcutaneous pulsed radio frequency treatment on the physiological status, subjective~     well-being, and on the intensity of pain. Category A Transcutaneous Pulsed Radiofrequency is~     a method that is widely used for control of pain. There are no known complications. In this~     study a Radiofrequency generator will be used that has a separate outlet for transcutaneous~     use. Patients will be recruited within the clinic population of patients.~   "
45764|NCT02967848|"~     This is a Phase 1 pilot study to assess feasibility and utility of 99mTc-mebrofenin~     hepatobiliary scintigraphy for measurement of functional liver change due to radiotherapy.~   "
45351|NCT02973256|"~     Meningiomas with malignant components include grade II meningiomas (GIIM, the most common~     ones) and grade III meningiomas (GIIIM). They represent 5-35% of all meningiomas.~     Histological diagnosis of GIIM criteria were changed in 2007 and might be viewed by some as~     being quite subjective. Standards of care and consensus do not exist for GIIM, particularly~     in regards to performing, or not, radiotherapy after surgery. One other limitation in the~     literature is lack of data on health-related quality of life (HRQoL). Clinical trials for~     GIIM are very difficult to conduct. No results have been made available. Here, we propose to~     study clinical, pathological, radiological and therapeutic factors of an exhaustive~     population of GIIM and GIIIM patients, at national level. The main objective (for GIIM) is to~     assess the impact of postoperative radiotherapy, or the absence of postoperative~     radiotherapy, on overall survival and on quality of life~   "
45352|NCT02973243|"~     To evaluate the effect of automated recording on frequency of recorded scores, number of~     automated notifications and serious events.~   "
45353|NCT02973230|"~     The aim of the present study was (i) to evaluate whether a single measurement of VEGF would~     allow us to distinguish between intrauterine pregnancy (normal and abnormal) and EP and (ii)~     to correlate the levels of VEGF with serum levels of progesterone and β-hCG in each subgroup.~      Ninety patients were selected from a population of women presenting to the Hospital das~     Clínicas of the University of São Paulo Medical School from October 2006 until September 2007~     and were divided in three subgroups: (i) abnormal (arrested) intrauterine pregnancy (defined~     as a gestational sac greater than 16 mm of mean diameter without fetal tissue or a embryo~     greater than 5 mm without embryo cardiac activity); (ii) tubal pregnancy (no evidence of~     intrauterine pregnancy, presence of a adnexal mass, suboptimal rise of serum hCG levels in 48~     hours); all tubal pregnancies were surgically treated and were histologically confirmed, they~     did not receive any methotrexate treatment before operation; (iii) normal intrauterine~     pregnancy (intrauterine gestational sac, embryo vitality confirmed).~      Blood samples were collected by peripheral venous puncture before treatment; a total 15 mL of~     blood was withdrawn (2 mL for β-hCG, 3mL for progesterone, 10 mL for VEGF determinations).~     Blood samples for VEGF were collected in siliconized tubes and were allowed to coagulate at~     room temperature for 2-6 hours.~   "
45354|NCT02973217|"~     Thermotherapy is a technology aiming at destroying tissue, for example tumor tissue.~     Immunostimulating Interstitial Laser Thermotherapy (imILT) is a specific form of~     thermotherapy, which, in addition to destroying tumor tissue, has been optimized to cause a~     tumor specific immunologic response. In laboratory animals the imILT method has also been~     shown to induce a so called abscopal effect. This means that when one tumor is treated with~     imILT other, untreated, tumors also decrease in size.~      The purpose of this trial is to evaluate efficiency when it comes to local tumor destruction~     of the imILT treatment method in patients diagnosed with pancreatic cancer. The purpose is~     also to investigate the functionality and safety as well as understanding of the subsequent~     immunological effects.~      This trial is prospective, open and non-randomized. Five patients diagnosed with pancreatic~     cancer will be treated in this trial, which is estimated to be carried out during a time~     period of 36 months.~   "
45355|NCT02973204|"~     Background Treatment and control of cancer is associated with high costs, to patients in the~     form of side effects and discomfort during investigations, to society in the form of~     expensive drugs and studies.~      Circulating tumor cells (CTC) has received great attention as a cancer biomarker in trying to~     estimate future course in patients with breast cancer, colon cancer and prostate cancer. CTC~     is believed to be a crucial step in cancer spreading to the bloodstream and giving rise to~     metastases. Detection of circulating tumor DNA (ctDNA) specifically adds specificity to the~     analysis of the CTC.~      The investigators would like to with molecular biological methods predict which patients~     requires special monitoring and individualized therapy and explore these tests as clinical~     decision support.~      Purpose and method~      In a blood sample from patients with neuro-endocrine tumor (NET) and hepatocellular carcinoma~     (HCC), the investigators will by cell separation, flow cytometry and DNA sequencing and~     digital polymerase chain reaction (PCR):~        1. Identify and isolate the CTC and investigate these for tumor-specific mutations.~        2. Quantify ctDNA and analyze this for specific mutations, which in the past has been found~          frequent in NET and HCC.~        3. Compare findings of mutations on CTC and ctDNA with mutations in tissue biopsies.~      The results are compared with the clinical data on disease course, including the effect of~     treatment and survival.~      Subjects 40 Patients with small intestinal/unknown primary NET before treatment with~     somatostatin analogues 30 patients with pancreatic NET before treatment with Everolimus 30~     patients with presumed radically treated HCC 30 patients with HCC in treatment with Sorafenib~     A blood sample will be taken prior to the start of treatment, after 1 month after start of~     treatment and thereafter every 3.-6. month for up to two years.~      Perspectives In several cancer types molecular diagnostics have had significant influence in~     treatment and control strategy. The goal is in future to be able to take advantage of a~     so-called liquid biopsy as clinical decision support. The study will bring new knowledge to~     this growing field of research.~   "
45356|NCT02973191|"~     This is a single-arm, multi-center, open-label, Phase 2 study to determine the efficacy and~     safety of JCAR015 in adult subjects with B-cell ALL. The study is divided into two sequential~     parts, Part A and Part B; subjects will be screened and will provide informed consent before~     initiating any study procedures in Part A of the study.~   "
45357|NCT02973178|"~     This study will test Scanadu Urine Device for clinical performance and usability.~   "
45358|NCT02973152|"~     The purpose of this study is to help determine the most effective treatment for participants~     with Unilateral Vocal Fold Paralysis.~      There are currently two types of operations used to treat this condition. One operation is~     called thyroplasty. Doctors place a small piece of safe plastic into the side of the~     participant's voice box to push the weak vocal cord into a position to enable better speech~     and swallowing. In the other operation called laryngeal reinnervation, doctors repair the~     neck nerve supply to the vocal cord using parts of other unaffected nerves to enable better~     speech and swallowing. The investigators do not know which of these methods is better and are~     conducting this study to start comparing the two operations so that a larger clinical trial~     can be conducted in the future to tell us which operation is best.~   "
45359|NCT02973139|"~     The purpose of this prospective randomized clinical trial is to compare two currently~     accepted standard-of-care treatment strategies: Medical thoracoscopy as compared to~     instillation of intrapleural tissue Plasminogen Activator (TPA) and human recombinant~     Deoxyribonuclease (DNase) for the management of empyema or complex parapneumonic effusion~     (CPPE) in adults.~   "
45360|NCT02973126|"~     The overall objective of the AFFECTS Study is to assess agreement between SPECT and FFRct in~     identifying vessel-specific, hemodynamically significant CAD in patients scheduled for~     invasive coronary angiography (ICA) based on abnormal SPECT myocardial perfusion scans. In~     particular, the study will evaluate the ability of FFRct to correctly rule out~     hemodynamically significant CAD in patients with non-significant CAD or normal coronary~     arteries who had positive SPECT scans.~   "
45361|NCT02973113|"~     Subjects have a type of a lymph node cancer called Non-Hodgkin's Lymphoma (NHL) or~     lymphoproliferative disease (LPD), which affects their immunity, blood production, and can~     involve multiple other organs in the body. Their disease has come back or has not gone away~     after treatment. The experimental treatment plan consists of an antibody therapy called~     Nivolumab that helps the subjects' T-cells control the tumor, and special immune system~     cells called EBV-specific cytotoxic T lymphocytes, also a new therapy whose side effects are~     well studied.~      Some patients with NHL or LPD are infected with the virus that causes infectious~     mononucleosis (called Epstein-Barr virus, or EBV) before or at the time of their diagnosis.~     The cancer cells that are infected by EBV are able to hide from the body's immune system and~     escape destruction. Investigators want to see if special white blood cells, called T cells,~     that have been trained to kill cells infected by EBV can survive in the blood and affect the~     tumor.~      Investigators have used this sort of therapy to treat a different type of cancer that occurs~     after bone marrow or solid organ transplant called post-transplant lymphoma with good~     success. These cells are called EBV-specific cytotoxic T-lymphocytes (EBVSTs), and are~     effective in treating these diseases. These EBVSTs are experimental and not yet approved by~     the Food and Drug Administration (FDA).~      Sometimes it is not possible to grow these cells; or they may not last very long in the body~     after being given into the vein thereby having only limited time to fight the tumor. With~     this study, investigators aim to increase the duration of time that the T cells can last in~     the body and can effectively fight the cancer by using nivolumab. Nivolumab is FDA approved~     for treatment of other kinds of cancer like lung cancer and a skin cancer called Melanoma.~      The purpose of this study is to find out if EBVST cells in combination with nivolumab are~     safe, to learn what the side effects are, and to see whether this therapy may help patients~     with EBV related lymphoma or LPD.~   "
45362|NCT02973100|"~     The purpose of this study is to evaluate the efficacy and safety of investigational doses of~     dulaglutide in participants with type 2 diabetes on metformin monotherapy.~   "
45363|NCT02973087|"~     The purpose of this phase 3 study is to investigate the efficacy and safety, including~     immunogenicity and thrombogenicity of prophylactic treatment with recombinant von Willebrand~     factor (rVWF) in subjects with severe von Willebrand disease (VWD).~   "
45364|NCT02973074|"~     The aim of this pilot study is to investigate an 4 weeks period of oral iron substitution in~     the course of Patient Blood Management in preparation for orthopedic surgery.~   "
45365|NCT02973061|"~     Analysis of the short-and long-term impact of recombinant growth hormone on attention deficit~     and hyperactivity charachteristics in children and adolescents. This will be examined in~     children prior to GH therapy and 3, 6 and 12 months during treatment, by filling validated~     questionnaires (Vanderbilt rating scales) evaluating ADHD.~      Data will be compared to healthy control group.~   "
45366|NCT02973048|"~     Over the past 15 years, cesarean delivery is most commonly performed under spinal anesthesia~     using hyperbaric bupivacaine which provides an adequate sensory and motor block. Despite~     effective surgical anesthesia, bupivacaine is associated with long duration motor block and~     dose-dependent maternal hypotension potentially harmful for the fetus. Prilocaine with its~     new 2% hyperbaric formulation (HP), developed recently, showed rapid onset of action and~     faster regression of motor block compared to other local anesthetics without noteworthy~     side-effects when used intrathecally. The aim of this randomized, multicenter, powered~     clinical trial is to investigate whether HP may be an efficient alternative to hyperbaric~     bupivacaine for scheduled caesarean delivery under spinal anesthesia, with more rapid~     rehabilitation and less adverse effects. Our hypothesis is that hyperbaric prilocaine offers~     shorter motor block and more rapid rehabilitation than bupivacaine.~   "
45367|NCT02973035|"~     Hypertensive patients are at increased risk of developing LV hypertrophy and myocardial~     fibrosis, which cause diastolic dysfunction. Because the activation of~     rennin-angiotensin-aldosterone system (RAAS) has been shown to induce LV hypertrophy and~     myocardial fibrosis, the RAAS may play a central role in the pathogenic process from~     hypertension to diastolic HF. Inhibitors of RAAS have been considered as a treatment option~     for these patients, and the angiotensin receptor blockers (ARB) have been of interest because~     they antagonize the effects of angiotensin II more completely. However, the Irbesartan in~     Heart Failure with Preserved Systolic Function (I-PRESERVE) trial reported that treatment~     with irbesartan did not reduce the risk of death or hospitalization for cardiovascular causes~     among 4,128 patients who had HF with a preserved LV ejection fraction. The degree of~     improvement of diastolic dysfunction was associated with the extent of systolic blood~     pressure reduction, whether a RAAS inhibitor or non-RAAS blood pressure lowering was used.~     Amlodipine is a potent and well-tolerated calcium channel blocker, and seems to be~     appropriate for achieving more aggressive systolic blood pressure target and improving~     diastolic dysfunction in hypertensive patients, because amlodipine is clinically very useful~     for controlling systolic blood pressure. Assessment of diastolic function by echocardiography~     will be helpful to determine whether addition of amlodipine or an ARB to standard therapy is~     more beneficial to hypertensive patients with diastolic dysfunction. The investigators~     hypothesize that amlodipine added to standard therapy will be superior to valsartan in~     improving diastolic dysfunction by lowering systolic blood pressure more effectively in~     hypertensive patients, and try to examine this hypothesis in a prospective, open-label,~     randomized comparison study using blinded echocardiographic evaluation for end point.~   "
45368|NCT02973022|"~     The aim of this study is to evaluate the impact of participation in Cancer Clear and Simple~     (CC&S) educational sessions on cancer prevention and screening. The researchers will recruit~     60 community members: 30 will receive CC&S training (intervention group) and 30 will not~     (control group). All 60 will be surveyed about their intent to change their behavior at the~     beginning of the study and their actual behavior changes and their screening behavior 6~     months after enrollment in the study.~   "
45369|NCT02973009|"~     The Sleeve Gastrectomy (SG) is a bariatric surgery procedure performed by laparoscopic~     booming in recent years.~      This is an effective intervention on weight loss over the long term with few early~     postoperative complications and low morbidity in the long term.~      Obesity is considered as a risk factor for hernia full after surgery by laparoscopy with a~     relative risk of 29% in connection with cholecystectomy.~      Several series showed a rupture rate on trocar from 0 to 0.7%, but each time with a clinical~     evaluation.~      Recently, it was shown eventrations rate between 26 and 38% under the Roux-en-Y gastric~     bypass with a rupture rate increased on epigastric trocar. The assessment in the context of~     this series was ultrasound.~      Recent data suggest that the absence of closure of the epigastric trocar of 12mm through an~     SG of first intention was associated with a hernia rate of 17% with a scannographic~     evaluation.~      Also, recently, Tabone suggests that the systematic closure of the epigastric trocar site~     would not be as effective as lateralize inserting the trocar from the white line of the~     abdomen. Change the positioning of this trocar induce an additional difficulty in handling~     instruments for the realization of the SG with an désaxassion instruments, a conflict between~     the instruments for the realization of the SG and the optical laparoscopy.~   "
45370|NCT02972996|"~     Lifestyle strategies that include dietary modification, such as consumption of a plant-based~     diet, are well recognized in disease prevention and may improve type 2 diabetes. Various~     components of a plant-based diet may contribute to its beneficial health effects, but there~     has been keen interest in the possibility that plant polyphenols may have a role. Blueberries~     are dietary sources of polyphenols, specifically anthocyanins. To date there are few human~     clinical trials evaluating the beneficial health effects of blueberries in populations with~     type 2 diabetes. The objective of the study is to determine if freeze-dried blueberries~     compared to a blueberry placebo will improve cardiometabolic parameters in men with type 2~     diabetes.~   "
45373|NCT02972957|"~     The live attenuated influenza vaccine (LAIV) is made up of weakened influenza viruses given~     into the nose and in early studies was shown to be better than the standard influenza vaccine~     at preventing infections in children. However, more recently, it has performed less well and~     it may also work less well in Sub-Saharan Africa. Not only do the investigators not know why~     this is, but the investigators also do not fully understand why LAIV produces stronger nasal~     antibody responses in some individuals but not others. Usually harmless bacteria that are~     present in participants noses can influence how our immune system works and variations in~     these may explain differences in how LAIV works. The project will recruit children given LAIV~     in the Gambia to gain further understanding of these issues.~      The investigators will measure a variety of responses to LAIV, including genes that can~     change their expression early after vaccination and use advanced computational techniques to~     identify new relationships between these genes and other LAIV responses. The investigators~     will also see whether nasal bacterial profiles in children who respond to LAIV are different~     from those who do not. In addition, the investigators will alter these bacteria in a subset~     of children with antibiotics and see whether this affects both nasal gene expression and~     later responses to LAIV.~   "
45374|NCT02972944|"~     Laparoscopic cholecystectomy is the only curative treatment for gallstone disease of acute~     calculous cholecystitis.The purpose of this study is to find the most effective treatment~     (laparoscopic cholecystectomy vs. conservative) for elderly patients with acute~     cholecystitis. Therefore a randomized multi-centre study of 200 elderly patients suffering~     from acute cholecystitis is performed.~   "
45375|NCT02972931|"~     The main purpose of this study is to unravel the mechanisms by which the Low Viral Reservoir~     Treated patients (LoViReT) maintain extremely low HIV-1 DNA levels despite having initiated~     cART during chronic HIV-1 infection. This group may have specific and different clinical,~     virological and immunogenetical characteristics, compared to patients with regular reservoir~     size, which might be useful to design new and more effective treatment approaches.~   "
45376|NCT02972918|"~     The purpose of this study is to evaluate whether preoperative optimization with levosimendan~     in heart failure patients undergoing hip fracture surgery improves haemodynamic and tissue~     perfusion parameters.~   "
45377|NCT02972905|"~     GSK2269557 is a potent and highly selective inhaled Phosphoinositide 3-Kinase (PI3K) delta~     inhibitor being developed as an anti-inflammatory and anti-infective agent for the treatment~     of inflammatory airway diseases, such as chronic obstructive pulmonary disease (COPD). The~     purpose of the study is to assess the safety, tolerability and pharmacokinetics (PK) of~     single and repeat doses of GSK2269557 administered via the ELLIPTA dry powder inhaler (DPI)~     to healthy Japanese subjects. This is the first time for Japanese subjects that GSK2269557~     will be administered via the ELLIPTA DPI with the addition of magnesium stearate.~      In each group of this study, subjects will receive a single dose of either GSK2269557 or~     placebo in Session 1 and receive daily dose of GSK2269557 or placebo for 10 days in Session~     2. Session 1 of the next dose strength may be run in parallel with the Session 2 of the~     previous dose. The doses planned for the study are 200 micrograms (mcg), 500 mcg and 700 mcg.~     There will be at least 10 days washout between the two dosing sessions. Follow up period will~     start 10 days (+-1 day) after the last dose of Session 2. A total number of 36 subjects will~     be enrolled for the study with 27 subjects receiving a dose strength of GSK2269557 and 9~     subjects will receive each dose strength of GSK2269557. ELLIPTA is a trademark of the GSK~     group of companies.~   "
45378|NCT02972879|"~     The aim of this study is to assess the effectiveness of therapeutic modalities (paraffin,~     ultrasound and orthotics) versus corticosteroid injection for trigger finger.~   "
45379|NCT02972866|"~     This study is to evaluate non inferiority of Eurofarma budesonide nasal spary x referral~     Astrazeneca budesonide. Half patients will receive Eurofarma medication and half patients~     will receive Astrazeneca medication. There is no placebo group.~   "
45380|NCT02972853|"~     The purpose of this study is to 1) determine whether Mindfulness Training for Primary Care~     (see study MINDFUL-PC: Integrating Mindfulness Into the Patient-Centered Medical Home - A~     Pilot Study) improves chronic disease management and 2) changes brain activation in~     neuroimaging tasks before compared to after the training. Neuroimaging fMRI tasks probe~     mechanisms related to self-regulation, such as attention/inhibition, emotion regulation,~     self-compassion, interoception and pain regulation.~      The study will also look at whether successful chronic disease management relates to the~     observed brain activation changes after compared to before the mindfulness intervention.~   "
45381|NCT02972840|"~     This study is evaluating the efficacy of acalabrutinib in combination with bendamustine and~     rituximab (BR) compared with placebo plus BR in subjects with previously untreated mantle~     cell lymphoma.~   "
45382|NCT02972827|"~     Comparison of noninvasive cardiac output monitor (NICOM, Cheetah Medical) with Edwards~     FloTrac minimally-invasive cardiac output monitor in predicting fluid responsiveness in~     sepsis and septic shock.~   "
45383|NCT02972814|"~     The investigators prospectively want to compare 3 clinical tests for measuring blood troponin~     levels in patients presenting to the emergency room with thoracic pain probably related to a~     myocardial infarction with regard to the time necessary to obtain the test results.~      The tests are one laboratory based test and two point of care tests.~   "
45384|NCT02972801|"~     Testicular tissue cryopreservation is an experimental procedure where a young boy's~     testicular tissue is retrieved and frozen. This technique is reserved for young male patients~     who are not yet producing mature sperm, with the ultimate goal that their tissue may be used~     in the future to restore fertility when experimental techniques emerge from the research~     pipeline.~   "
45385|NCT02972788|"~     The purpose of the study is to determine the effect of enamel matrix protein derivative on an~     inflamed, periodontal-involved tooth. The hypothesis to be studied is that enamel matrix~     derivative protein with increase the clinical attachment level is localized sites of advanced~     periodontal disease.~   "
45386|NCT02972775|"~     The investigators examine the 15-year mortality after an admission for an exacerbation of~     Chronic Obstructive Pulmonary disease (COPD).~   "
45765|NCT02967835|"~     Will Tele-psychiatry be effective and acceptable to patients.~   "
45387|NCT02972762|"~     The investigators,according to the eligibility criteria,plane to choose 80 elderly~     anticipates who will undergo selective hip replacement surgery.This participants will be~     randomly divided into 2 groups:light anesthesia depth group(L Group) and deep anesthesia~     depth group (D Group).Before anesthesia induction,each participant will be given lumbar~     plexus and sciatic nerve block in order to control pain of interoperative and~     postoperative.During operation period,the L Group will be kept in light anesthesia~     depth(BIS:50-60),while the D group will be kept in deep anesthesia depth(BIS:35-45)--The BIS~     values in the range of 30-60 have been recommended in general anesthesia.After operation,a~     PCIA(patient controlled intravenous analgesia) analgesia pump will be given to each~     participant to control postoperative pain. The investigator will evaluate the mental state of~     participant with MMSE(mini-mental state examination) before surgery and review each~     participant with a CAM-CR for 3 days after surgery to assess the situation of postoperation~     delirium.intraoperative awareness,postoperative pain will also be investigated in~     postoperative days 1, 2, 3.~   "
45388|NCT02972749|"~     There is growing awareness that environmental factors, behaviors and diet are intimately~     related to patient health and may play a role in the pathogenesis and progression of~     glaucoma. Evidence from recent years has shown that some behaviors and environmental factors~     can affect the intraocular pressure, the primary risk factor for glaucoma. This study aims to~     investigate whether simple and common lifestyle inteventions such as sleeping with a head~     elevation, a high fiber diet, moderate aerobic exercise and moderation in caffeine intake~     could affect intraocular pressure and other outcomes.~   "
45389|NCT02972736|"~     Retrospective multicenter study aimed to evaluate radiation exposure associated with~     different interventional procedures involving interventional cardiologists, interventional~     radiologists and electrophysiologists.~   "
45390|NCT02972723|"~     Hepatitis C virus infection (HCV) is a major cause of cirrhosis and death from liver disease~     worldwide. Current therapy for HCV with interferon based therapies results in cure rates of~     around 5055% which leaves a significant number of patients without effective therapy. HCV~     induces (can bring on) insulin resistance and insulin resistance is a factor known to reduce~     the response to antiHCV therapy. This finding stimulated initial studies looking at agents~     that may reduce insulin resistance as additional therapy in HCV infection.~      A study using metformin in addition to interferon and ribavirin showed a nonsignificant~     increase in cure rates (53% vs. 42%), but this was limited to patients with type 1 infection~     AND demonstrable insulin resistance. The assumption was made that the potential effect of~     metformin was likely to be on insulin resistance and thus by modulating this enhances~     response. The investigators (Prof M Harris, University of Leeds) have data (currently~     unpublished)suggesting that metformin may have an antiviral effect independent of its effect~     on insulin resistance, thus raising the possibility that metformin may have a direct~     antiviral effect in vivo. Given that the development of specific antiHCV agents which target~     viral proteins such as its polymerase and protease are in trial development but have so far~     proved either highly toxic or are likely to have a huge cost there is considerable rationale~     for looking at alternative potential antiHCV agents and in this context metformin is cheap,~     readily available and has an excellent safety profile. This pilot study therefore addresses~     the question Does metformin therapy result in a significant drop in HCV viral load in~     chronically infected patients?~   "
45391|NCT02972710|"~     The purpose of this study is to compare the short-term effects of two different thoracic~     spine thrust manipulation techniques on neck range-of-motion, pain, and self-reported~     disability in individuals experiencing neck pain.~   "
45392|NCT02972697|"~     Imaging using 11C-acetate PET (positron emission tomography) in patients with tuberculosis~     (TB) may be able to detect non-replicating persister bacilli. This may permit identification~     of those patients at risk of relapse following completion of TB treatment. The main aim of~     this pilot study is to assess the ability of 11C-acetate PET to detect pulmonary lesions in~     individuals with active pulmonary TB.~   "
45393|NCT02972684|"~     Peri operative haemorrhage following cardio Pulmonary Bypass may occur in 5 to 10% of cardiac~     surgical interventions.~      Treatment of such complication often necessitates various combinations therapeutic~     intervention including allogenic blood products administration, drug use and/or surgical~     intervention. All are expensive treatment and decision making is guided by patient clinical~     status and biological tests of the haemostatic function.~      A key point is the time frame of the clinical process. Therapeutic choices have to be done as~     fast as possible to minimize bleeding consequences on patient haemodynamic and physiological~     status. Conventional coagulation test results availability time usually exceed 45' after~     blood drawing. In such situation, the results may not reflect precisely the coagulation~     system current state. This downside is often counterbalanced by clinicians empirical choices~     preceding lab test results knowledge that may conduct to inappropriate treatment, blood~     product overuse and undue expense.~      Viscoelastic point of care test may compensate for the limitations of conventional~     coagulation tests. In perioperative haemorrhage, faster and more precise information about~     haemostatic function may help for more accurate therapeutic choices.~      The IMOTEC study aims to compare haemorrhage management following cardiac surgery using~     conventional blood coagulation tests or thrombo-elastogaphic point of care test.~      Primary endpoint is a cost utility analysis of the technology and secondary endpoints include~     blood component transfusion, postoperative bleeding , thoracic re-intervention, postoperative~     infection (any cause), organ failure, in hospital length of stay and death.~   "
45394|NCT02972671|"~     To compare the MT005 (MiStent) with the XIENCE with respect to target lesion failure (TLF) at~     12 months in a non-inferiority trial in a real world patient population and to confirm that~     the domestic extrapolation of the DESSOLVE III study results is valid.~   "
45395|NCT02972658|"~     This study is an extension of study I8D-MC-AZES (NCT02245737), the AMARANTH study. The~     purpose of this study is to evaluate the effectiveness of the study drug lanabecestat in~     participants with early Alzheimer's disease dementia at the time of entry into study~     I8D-MC-AZES.~   "
45396|NCT02972645|"~     The purpose of this study is to evaluate the safety of LY3305677 and any side effects that~     might be associated with it.~      This study will also look at how much LY3305677 gets into the blood stream, how long it takes~     the body to remove it.~      This study involves a single dose of LY3305677 administered by subcutaneous injection (SC).~      Participation in this study is expected to last up to 16 weeks.~   "
45398|NCT02972619|"~     Background: Hypertension is a serious public health problem responsible for significant~     mortality and morbidity from cardiovascular disease. In Singapore, 1 in 4 adults age 30 years~     or older suffer from hypertension. Nearly half of these patients have uncontrolled~     hypertension and only 50% of individuals are on antihypertensive treatment. Our study aims to~     evaluate the effectiveness, cost effectiveness and impact on medication adherence of a~     well-structured program using multicomponent intervention for hypertension control aimed at~     overall cardiovascular risk reduction among individuals with hypertension attending the~     polyclinics in Singapore, compared to existing services. Such a program is expected to be~     cost-effective in terms of improving hypertensive individuals' outcomes, and to be~     potentially scalable and sustainable.~      Methods/design: Cluster randomized trial of 8 of the nine SingHealth Polyclinics randomized~     to intervention or usual care (4 each) and followed up for 2 years post randomization~      Intervention: The structured multicomponent primary care program comprises of: 1)~     algorithm-driven antihypertensive treatment for all hypertensive individuals and using~     fixed-dose combination (FDC) and lipid-lowering medication for high-risk hypertensive~     individuals, 2) motivational conversation for high-risk hypertensive individuals, 3)~     Follow-up of all hypertensive individuals on improving blood pressure (BP) as a primary~     outcome and other cardiovascular risk factors as a secondary outcome, and 4) discounts on FDC~     antihypertensive medication~      Usual care: The participants attending polyclinics randomized to usual care will continue to~     receive treatment from the health providers according to existing practices. The hypertensive~     individuals will also continue to pay for the services (physician or nurse consultation) as~     per their existing model of reimbursement.~      Participants: A total of 1000 participants will be recruited, 125 from each of the 8~     polyclinics. Recruitment will be in batches of 4 and 4 clinics sequentially (balanced by~     randomization group).~      Outcomes: All hypertensive individuals will be assessed by trained outcomes assessors~     independent to treatment at baseline, 1-year and 2-yeat post randomization. The primary~     outcome will be the change in systolic blood pressure from baseline to 2 years. Primary~     Cost-Effectiveness measures will be- 1) Incremental cost per mm Hg systolic BP reduction from~     baseline to end of follow-up at two years post randomization; 2) incremental cost per~     projected CVD disability adjusted life years (DALYs) averted and quality adjusted life years~     (QALYs) saved, and 3) incremental cost per change in cardiovascular risk score from baseline~     to final follow-up at two-year post. The impact of effect on adherence to antihypertensive~     and lipid medication will be measured using data on adherence obtained from polyclinic~     pharmacy records and clinic notes. An average of percent adherence to antihypertensive and~     lipid lowering will be computed as a composite score. The change in percent composite~     adherence to antihypertensive and lipid medications from baseline to follow up will be~     compared between the intervention and control groups.~   "
45399|NCT02972606|"~     Presently, there are few options for medically managing HIV-related painful peripheral~     sensory neuropathy (HIV-SN). Psychological treatments, including Cognitive Behavioural~     Therapy (CBT), represent a potentially viable addition to the treatment of painful HIV-SN.~     However, there is a scarcity of research on psychological treatment approaches for pain~     management in people with HIV. This study will use in-depth semi-structured interviews to~     examine the needs of people with painful HIV-SN for a psychologically-based pain management~     treatment that may be delivered over the Internet. Interview questions will examine~     participants' needs in terms of treatment content and delivery format. Men and women, ethnic~     minorities, and people who use recreational drugs will be sampled to ensure that interview~     responses reflect the views of people most commonly suffering from this condition.~     Approximately 30 people will be recruited for the study. The interviews will be audio~     recorded, transcribed verbatim, and coded to identify themes. The interview responses will be~     used to develop and tailor a version of CBT for people with painful HIV-SN. It is hoped that~     tailoring the treatment based on the qualitative interview responses will increase the~     acceptability of the treatment and will improve treatment adherence rates for a future study.~   "
45400|NCT02972593|"~     The purpose of this study is to determine if there is a difference in outcomes between~     liberal transfusion (transfusing when hemoglobin drops below a set higher value number) and~     conservative transfusion (transfusing when hemoglobin drops below a set lower value number).~   "
45401|NCT02972580|"~     Longitudinal prospective observational study. This is a 24-month study with the possibility~     of extending the data time points. Initially baseline, then 12 and 24 months follow up~     studies will be completed.~   "
45402|NCT02972567|"~     The purpose of this study is the evaluation of the effects in obese patients with metabolic~     syndrome on the composition of the intestinal microbiota, markers of the syndrome~     (hypertension, dyslipidemia, inflammation biomarkers, risk cardiovascular and hepatic~     steatosis) and other possible metabolites involved.~   "
45403|NCT02972554|"~     This randomized, double-blind, placebo-controlled study of propranolol will shed important~     light on how sympathetic nervous system (SNS) activation influences our psychological and~     inflammatory responses to acute stress. Results from this study will inform both the basic~     science literature that is attempting to map the physiological mechanisms by which~     psychological stress may lead to poor mental and physical health, and may also ultimately~     have therapeutic relevance for individuals who are experiencing high levels of stress that is~     putting their health at risk. By utilizing psychopharmacological approaches, the~     investigators will circumvent many of the challenges of conducting this research in human~     populations. The investigators will also be in a place to draw strong conclusions regarding~     causality, given that they will have experimentally manipulated SNS activation, rather than~     relying on correlational measures of SNS activity that are difficult to assess and are not~     appropriate for asking if SNS activity causes changes in psychology and biology.~   "
45404|NCT02972541|"~     Colorectal cancer is the fourth most common cancer in China. Up to 30% of patients with~     colorectal cancer present with an emergency obstruction of the large bowel at the time of~     diagnosis, and 70% of all malignant obstruction occurs in the left-sided colon. Patients with~     obstruction are associated with worse oncologic outcomes compared with those having~     nonobstructive tumors. Conventionally, patients with malignant large bowel obstruction~     receive emergency surgery, with morbidity rates of 30%-60% and mortality rates of 7-22%, and~     about two-thirds of such patients end up with a permanent stoma.~      Self-expanding metallic stents (SEMS) haven been used as a bridge to surgery (to relieve~     obstruction prior to elective surgery) in patients with potentially resectable colorectal~     cancer. Several clinical trials demonstrate that SEMS as a bridge to surgery may be superior~     to emergency surgery considering the short-term outcomes. SEMS is associated with lower~     morbidity and mortality rate, increased primary anastomosis rate, and decreased stoma~     creation rate. Although about half of patients can achieve primary anastomosis after stent~     placement, the primary anastomosis rate is still significantly lower compared with~     nonobstructing elective surgery. The interval between stent placement and surgery may be not~     long enough that bowel decompression is insufficient at the time of operation.~     Furthermore，the long-term oncologic results regarding SEMS as a bridge to surgery are still~     limited and contradictory. Sabbagh et al. suggest worse overall survival of patients with~     SEMS insertion compared with emergency surgery, the 5-year cancer-specific mortality was~     significantly higher in the SEMS group (48% vs 21%, respectively, P=0.02). One interpretation~     is that tumor cells may disseminate during the procedure of colonic stenting placement. We~     hypothesis that immediate chemotherapy after stenting may improve overall survival by~     eradicating micrometastasis. Moreover, neoadjuvant chemotherapy prolongs the interval between~     stent placement and surgery, and the time for bowel decompression is more sufficient, which~     may increase the success rate of primary anastomosis and decrease risk of stoma formation.~   "
45405|NCT02972528|"~     Allogenic defibrinated platelet rich plasma lysate will be injected in patients diagnosed~     with Diabetic Foot Ulcer (DFU).~   "
45439|NCT02972086|"~     The purpose of this study is development of the Integrative Pediatric FPA ADHD Care (IPFAC)~     Model. The IPFAC is intended to increase access to evidence-based behavioral parent training~     (BPT) for school-age children diagnosed with attention-deficit/hyperactivity disorder(ADHD)~     who are diagnosed with ADHD and served in the ADHD Clinic at NYU Bellevue's Department of~     Developmental and Behavioral Pediatrics.~   "
45999|NCT02964767|"~     A cross sectional study would be done for prevalence of HIV-Tb. co infection among patients~     of HIV enrolled at ART centre, Khagaria, India, during June' 2015 to May' 2016. A comparative~     study of CD4 (cluster of differentiation 4) T cell count among HIV-Tb. co infected patient~     and HIV patients would be taken in account.~   "
45406|NCT02972515|"~     Tobacco use among women now approaches that of men, with approximately 27 million women~     smokers in the United States alone. Women report greater difficulties quitting smoking and~     are more likely to relapse than men. In addition, tobacco use co-varies with poor dietary~     practices and lack of physical activity, with 92% of smokers reporting at least one other~     health risk factor. Concerns surrounding weight gain, negative body image, and low~     self-efficacy, may be key factors affecting smoking cessation among weight-concerned women~     smokers. Guided imagery has been successfully employed in separate lines of inquiry to~     address physical activity, diet and smoking cessation. However, guided imagery has not been~     employed to target weight concerned women who smoke or to simultaneously target smoking,~     diet, and exercise behavior in a single intervention. The proposed study would be the first~     of its kind to create a theory-based, guided imagery intervention to assist weight-concerned~     women smokers to quit. The use of a mobile app offers an innovative approach to addressing~     the multiple behaviors involved in smoking cessation efforts of weight-concerned women, and~     has the potential to reach large numbers of women smokers. The project aims to develop and~     test the feasibility of a mobile health application using guided imagery in order to increase~     smoking cessation among a population of weight-concerned women smokers.~   "
45407|NCT02972502|"~     Metoclopramide (Reglan) is a common agent used for relief of headaches in the emergency~     department (ED).In this study the investigators seek to explore another option for treatment~     of headaches in the ED, one that may be more efficacious and efficient. Haloperidol (Haldol),~     a butyrophenone class of medication, is thought to act by affecting the dopamine 2 receptor~     in the brain.~      By exploring haloperidol as an option for treatment, the investigators hope to discover a~     more efficient and effective medication for the treatment of non-traumatic headaches, thereby~     decreasing a patient's length of stay in the department and decreasing the rate of return~     visits for continued discomfort from the same headache. This study could lead to the~     increased usage of haloperidol as a first line agent in the treatment of prolonged headaches~     presenting to the ED.~   "
45408|NCT02972489|"~     The primary purpose of this study is to determine whether bifurcation stenting guided by~     on-line three-dimensional optical frequency domain imaging (3D-OFDI) is superior to that with~     angiographic guidance by measuring incomplete stent apposition (ISA) in the bifurcation~     segment.~   "
45409|NCT02972476|"~     A randomised controlled trial to test the hypothesis that inhaled therapies for chronic~     obstructive pulmonary disease (COPD) have differential effects on the upper airway~     microbiome.~      COPD is the third leading cause of death worldwide. Exacerbations drive disease progression~     and worsening quality of life and therefore prevention of exacerbations has been a major goal~     of treatment.~      Patients with COPD are frequently prescribed inhaled corticosteroids (ICS) which have been~     shown to reduce exacerbations in combination with long acting beta2-adrenoceptor agonists~     (LABA). In recent years, all ICS preparations have been associated with a significant~     increased risk of pneumonia in either randomised trials or observational studies leading to~     warnings from national regulatory authorities and leading experts. This has led to a~     re-evaluation of the role of ICS in COPD treatments. It is likely that the risk of pneumonia~     is not equal across all ICS doses and molecules.~      There is a compelling rationale for ICS having a strong effect on the upper airway~     microbiome, and that this may be one mechanism of increased pneumonia risk with these drugs.~     The existing literature regarding ICS and pneumonia risk are lacking; 1) there are no head to~     head trials comparing different ICS preparations and 2) the comparator in these studies to~     date have been long acting beta2-adrenoceptor agonists alone, whereas the most appropriate~     comparator in current management would be combined LABA and long-acting muscarinic antagonist~     (LAMA).~      The MUSIC TRIAL is a multi-centre randomised open label controlled parallel group study with~     four treatment arms and a total of 120 participants. Severe COPD patients currently treated~     with inhaled corticosteroid therapy will be randomised to treatment with one of three~     preparations of ICS in combination with LABA or the control arm of dual bronchodilator~     therapy following a four week washout period. Participants will return monthly to determine~     if there are changes in the microbiome in their upper airway.~      This study will establish one potential mechanism for the increased susceptibility to~     pneumonia in ICS users and assess intraclass differences in ICS molecules and the effect of~     ICS dose on the microbiome. Demonstrating that different COPD treatments can have different~     effects on the lung microbiome is an important step in understanding clinical differences in~     the safety and effectiveness of different treatments for severe COPD.~   "
45410|NCT02972463|"~     The purpose of this study is to determine the optimal dose of IgY as assessed by changes in~     the inflammatory marker, C-reactive protein and investigate the effect of IgY on the gut~     microbiome as assessed by 16s RNA sequencing of fecal samples.~   "
45411|NCT02972450|"~     EVHA T01 is an international, phase I/II, multicentre, multi-stage, double-blind study that~     will evaluate at least three experimental arms compared to placebo control in HIV-1 infected~     participants to see if one or more has a clinically relevant impact on the control of viral~     replication.~   "
45412|NCT02972437|"~     The investigators intend to screen children who are suspected of having GAS tonsillitis. From~     each child we will take a throat culture and saliva sample to screen for molecular evidence~     of GAS.~   "
45413|NCT02972424|"~     In the proposed trial the investigators will recruit women and men >65 years of age with~     acute osteoporosis-related pelvic fractures and address 3 specific aims over 3 months of~     treatment in a placebo controlled double blind study to determine if standard care and~     teriparatide 20 mcg/day versus placebo for pelvic fractures:~        1. Results in earlier evidence of cortical bridging on routine radiographs followed by~          confirmatory Focus CT, a novel method to reduce radiation exposure from CT scans~          (primary outcome).~        2. Leads to a faster reduction in pain as assessed by both the Numeric Rating Scale and a~          reduction in the use of narcotics (secondary outcome).~        3. Leads more rapidly to improved functional outcome using a short physical performance~          battery to assess lower extremity function (secondary outcome).~   "
45414|NCT02972411|"~     This study evaluates the safety and efficacy of the voluntary ventilatory response as~     prophylaxis for acute mountain sickness, measured by the Lake Louise Self-Report Score,~     comparing to a group using acetazolamide.~   "
45415|NCT02972398|"~     The aim of this study is to evaluate the efficacy of N-acetylcysteine (NAC) add-on to~     antidepressant medication in treating patients who do not relieve during standard~     antidepressant treatment for 6 weeks at least. Meanwhile, secondary outcomes will include~     changes in some biomarkers and on specifically local brain activity (functional Magnetic~     Resonance Imaging, fMRI) and white matter integrity (Diffusion Tensor Imaging, DTI). The~     hypothesis of this study is that NAC has positive effects on refractory major depressive~     disorder patients with increased inflammatory activity.~   "
45440|NCT02972073|"~     The purposes of this study include 1) determine clinical utility of clinical observation of~     aberrant movement patterns during functional trunk and pelvic movements in asymptomatic~     individuals and patients with non-specific low back pain, 2) characterize trunk neuromuscular~     control in asymptomatic individuals and patients with non-specific low back pain, and 3)~     determine the appropriate physical therapy intervention that addresses trunk neuromuscular~     control deficits in patients with non-specific low back pain.~   "
45416|NCT02972385|"~     Warfarin is a commonly used blood thinner to treat and prevent blood clots. It is important~     to take the right dose of warfarin because too much can increase the risk of bleeding and too~     little can increase the risk of blood clots. This is why patients are closely monitored~     especially when they begin warfarin therapy. When clinicians prescribe warfarin, they have to~     consider different factors such as patient's age, body size, diet, and other medications that~     can interact with warfarin.~      Certain genes have also been found to affect warfarin dose. Individuals have variations in~     these genes, which can help explain why some patients need higher dose and others require~     less. These factors have been used to better predict a patient's warfarin dose requirement.~     However, these predictions were created based on Caucasian populations and they may not be~     accurate in predicting a safe warfarin dose if a patient is not Caucasian. This study aims to~     identify new genetic variation that affects warfarin dosing in Hispanic and Latino~     populations and try to better predict a Hispanic or Latino patient's warfarin dose~     requirement.~   "
45417|NCT02972372|"~     The aim of this study is to compare outcomes in Chinese patients with locally advanced~     resectable esophageal squamous cell cancer who have received either surgery or definitive~     chemoradiation (CRT) by the randomized, open-label, multicenter trial.~   "
45418|NCT02972359|"~     The aim of this trial is to investigate the safety of intravenous neridronic acid in patients~     with complex regional pain syndrome (CRPS).~      The trial is divided into 3 periods: a 60-day enrollment period, a treatment period~     consisting of 4 infusions over 10 days, and a follow-up period of approximately 50 weeks~     (with visits at Week 2, Week 6, Week 12, Week 26, Week 39, and Week 52).~   "
45419|NCT02972346|"~     Primary nephrotic syndrome(NS) is a common children renal disease.About 20% primary nephrotic~     syndrome are steroid-dependent and steroid-resistant.Low serum cortisol is one of the main~     relapse reasons.Adrenocorticotropic hormone(ACTH)-induced steroidogenesis improve serum~     cortisol and also direct melanocortin receptors(MCRs) mediated protective effect on kidney~     cells. To investigate the efficacy and safety of ACTH to treat NS, total 42 children steroid~     resistant or steroid dependent NS is enrolling in this multicenter, prospective case series~     of prescription based treatment with ACTH for NS.~   "
45420|NCT02972333|"~     The study aims to investigate the efficacy and safety of AZD9291 in brain metastases from~     patients with EGFR T790M positive NSCLC who have received prior therapy with an EGFR-TKI.~   "
45421|NCT02972320|"~     This study evaluates temozolomide maintain therapeutic efficacy and safety in extensive stage~     SCLC who has clinical benefit from etoposide combined Los platinum (EL) scheme in the first~     line treatment.~   "
45422|NCT02972307|"~     There has been only minimal research on wheelchair skills by the caregivers of manual or~     powered wheelchair. There are no published data on the extent to which caregivers can enhance~     the mobility of powered wheelchair users. The primary objective of this study is to test the~     hypothesis that caregivers enhance the wheelchair skills capacity, confidence and performance~     of the powered wheelchair users to whom they provide assistance. Our secondary objective is~     to add to the literature on the measurement properties of the wheelchair skills test~     (questionnaire and capability version) for powered wheelchair users and their caregivers.~   "
45423|NCT02972294|"~     Fractures of the upper end of the femur, called commonly Hip fractures are very common,~     with an incidence of approximately 1.6 million cases per year worldwide. This high incidence~     is anticipated to grow rapidly in the next decades, driven by population aging. Anemia is~     very frequent on admission for hip fracture, concerning up to 45% of the patients, with a~     mean hemoglobin level of 12.5±0.2 g/dl. This high prevalence of anemia together with blood~     losses, secondary to the fracture itself and surgery are responsible for a high rate of blood~     transfusion (approximately 40-50% of the patients). However, both anemia and blood~     transfusion are associated with poor outcome, including increased mortality, length of stay,~     infection rate etc. In addition, blood is a scarce and expensive resource and its use should~     be limited as much as possible. There is therefore a need to treat this anemia and/or to~     prevent the decrease in hemoglobin. For this purpose, intravenous iron has been proposed.~     Some non-randomized, mainly retrospective, studies have shown that perioperative intravenous~     iron was able to reduce blood transfusion (i.e. the number of patients transfused and the~     number of units per patient). Another way to reduce blood transfusion would be to reduce~     perioperative bleeding. Tranexamic acid has proven to be efficient for this purpose both in~     trauma patients and in elective surgery patients.The interest for perioperative blood~     management has recently increased thanks to better recognition of the adverse effects of~     blood transfusion, better understanding of iron metabolism, new intravenous iron drugs and a~     renewed interest in former medications (i.e. tranexamic acid). HiFIT study therefore propose~     a 2X2 factorial design for this study in order to answer questions vis-à-vis the interest of~     iron and tranexamic acid to reduce blood transfusion in hip fracture patients.~   "
45424|NCT02972281|"~     Antibody deficiencies and complement deficiencies are the most frequent Primary~     immunodeficiencies (PIDs) in adults, and are associated with greatly increased susceptibility~     to recurrent and/or severe bacterial infections - especially upper and lower respiratory~     tract infections and meningitis. The literature data suggest that PIDs are under-diagnosed in~     adults. The current European and US guidelines advocate screening adults for PIDs if they~     present recurrent benign especially upper and lower respiratory tract infections, or if they~     have experienced at least two severe bacterial infections and/or have a recurrent need for~     intravenous antibiotics. The objective of the demonstrate the interest of PIDs screening in~     adult patients who present such recurrent infections and/or after the first severe bacterial~     infection, especially when the patients do not present with known, etiologically relevant~     comorbidities.~   "
45425|NCT02972268|"~     Clinical Trial to Compare the Efficacy and Safety of Solifenacin/Tamsulosin Combination~     Therapy with Tamsulosin Monotherapy for Lower Urinary Tract Symptoms due to Benign Prostatic~     Hyperplasia~   "
45426|NCT02972255|"~     This is a randomized, double-blind, placebo-controlled, multiple-ascending dose (MAD) study~     that will evaluate the safety, tolerability and pharmacokinetics (PK) of RO7079901 and the~     combination of RO7079901 with meropenem in healthy volunteers. The study will consist of~     three parts (Part I, II, and III). At each dose level/cohort, a total of 8 healthy volunteers~     will be randomized to receive active study drug or placebo in a 3:1 ratio.~   "
45441|NCT02972060|"~     This is an open label non-comparative controlled randomized phase II study. The experimental~     arm is the group receiving ODM-201. The group receiving androgen-deprivation therapy (ADT) is~     included as an internal control.~      The primary trial objective is to demonstrate that ODM-201 produces prostate-specific antigen~     (PSA) response rates at 24 weeks (defined as ≥80% reduction compared to baseline) that are in~     the range of those achieved with 24 weeks of ADT.~      In total, this 1:1 randomized study will therefore require randomization of at least 250~     patients, 125 to each arm.~   "
45427|NCT02972242|"~     Coronary computed tomography angiography (CCTA) is a frequently performed test for the~     diagnosis and/or exclusion of coronary artery disease (CAD) in appropriately selected~     patients. The performance of non-contrast computed tomography for the detection and~     quantification of coronary calcification is typically performed prior to CCTA in an effort to~     identify significant calcification which may influence subsequent data acquisition during the~     CCTA. However, performance of calcium scoring adds significant radiation and most coronary~     calcification is proximal in its location, potentially visualized using a focused~     non-contrast scan.~      The purpose of this study is to prospectively compare the usefulness of a modified~     non-contrast CT, using a significantly shorter scan length and lower radiation parameters, as~     compared to standard coronary artery calcium scanning for the detection of coronary~     calcification that may influence subsequent CCTA performance.~   "
45428|NCT02972229|"~     To compare the treatment effect and toxicity between Intensity-Modulated Radiation therapy~     for whole metastatic vertebral body and simple metastatic lesions of vertebra in metastatic~     spinal tumors~   "
45429|NCT02972216|"~     A Post-marketing Surveillance Study to Evaluate the Effectiveness and Safety of~     Docetaxel-Based Chemotherapy~   "
45430|NCT02972203|"~     Specific aims for this pilot study are:~      (Behavioral health outcomes aim): Among primary care patients, compare the effectiveness of~     an 8-week mindfulness-based intervention (Mindfulness Training for Primary Care[MTPC]) vs. a~     60-minute introduction to mindfulness plus referral to community resources on measures~     related to anxiety, depression, and stress, and self-management of chronic illness.~      (Medical Regimen Adherence Aim): Among primary care patients, compare the effectiveness of~     MTPC vs. 60-minute introduction to mindfulness on the initiation and maintenance of an action~     plan.~      (Patient-Provider Relationship Aim): To examine the effects of level of primary care provider~     mindfulness training on successful referral to program, patient-provider relationship~     measures, and on patient action plan initiation and maintenance.~   "
45431|NCT02972190|"~     Laminectomy with PLIF has been shown to achieve satisfactory clinical outcomes, but it leads~     to potential adverse consequences associated with extensive disruption of posterior bony and~     soft-tissue structures. The investigators plan to compare the clinical and radiographic~     outcomes of bilateral decompression with transforaminal lumbar interbody fusion and~     laminectomy with posterior lumbar interbody fusion in the treatment of degenerative~     spondylolisthesis.~   "
45432|NCT02972177|"~     The objective of the study was to evaluate the efficacy and safety of navigation bronchoscopy~     guided transbronchial ablation for the treatment of early-stage inoperable peripheral lung~     cancer.~   "
45433|NCT02972164|"~     Levels of overweight and obesity have reached alarming proportions in Qatar and other Gulf~     nations. In Qatar, the need to establish national strategies for the prevention and treatment~     of obesity has been recognized in the new Qatar National Health Strategy 2011-2016, which~     stresses the need for prevention. In fact, the Qatar National Nutrition and Physical Activity~     Action Plan 2011-2016 calls for nutrition and physical activity interventions for the~     prevention of obesity and related chronic diseases such as diabetes. The treatment and~     prevention of childhood obesity is largely through lifestyle changes- encouraging health~     eating and physical activity and discouraging sedentary behavior. However, changing such~     behaviors is complex and requires a combination of integrated approaches to tackle such a~     multifaceted problem. Herein, the investigators set out to implement and evaluate a novel~     weight management program for Qatari school children at the vulnerable age of 9-12 years. The~     project incorporates a cognitive-behavioral approach that involves developing social and~     emotional competences, promotion healthy dietary habits, development of physical literacy,~     and use of activity monitoring devices to promote increased activity while enlisting family~     involvement in an attempt to maintain weight loss in the long term. This project seeks to~     also take things further by integrating a range of interventions that use cutting edge~     insights from the behavioral sciences through the use of MINDSPACE approach (MINDSPACE:~     Messenger, Incentive, Norms, Default, Salience, Priming, Affect, Commitment, Ego) in~     conjunction with technology tools for monitoring activity and providing ongoing support~     through the use of social media. The intervention involves a multi-cohort intervention~     involving 500 Qatari children over 5 years to be conducted in three phases (1) intensive~     weight loss camps, (2) after-school clubs as supplement/consolidation, and (3) maintenance~     through web and social/family support.~   "
45434|NCT02972151|"~     The trial attempts to optimize, standardize and simplify the characteristic diagnosis and~     treatment program of the dominant diseases in our hospital-the sequelae of pelvic~     inflammatory disease, so as to make it suitable for clinical diagnosis and treatment in~     primary hospital.~   "
45435|NCT02972138|"~     Sickle cell disease (SCD) is a worldwide distributed hereditary red cell disorder, which~     affects approximately 75,000 individuals in the United States and almost 20,000- 25,000~     subjects in Europe, this latter mainly related to the immigration fluxes from endemic areas~     such as Sub-Saharian Africa to European countries. Studies of global burden disease have~     pointed out the invalidating impact of SCD on patient quality of life. This requires the~     development of new therapeutic options to treat sickle cell related acute and chronic~     complications. SCD is caused by a point mutation in the β-globin gene resulting in the~     synthesis of pathological hemoglobin S (HbS). HbS displays peculiar biochemical~     characteristics, polymerizing when deoxygenated with associated reduction in cell ion and~     water content (cell dehydration), increased red cell density and further acceleration of HbS~     polymerization. Pathophysiological studies have shown that dense, dehydrated red cells play a~     central role in acute and chronic clinical manifestations of SCD, in which intravascular~     sickling in capillaries and small vessels leads to vaso-occlusion and impaired blood flow~     with ischemic/reperfusion injury. In microcirculation, vaso-occlusive events (VOC) result~     from a complex and still partially known scenario, involving the interactions between~     different cell types, including dense red cells, reticulocytes, abnormally activated~     endothelial cells, leukocytes, platelets and plasma factors. Target organs, such as bone or~     lung, are involved in both acute and chronic clinical manifestations of SCD, related to their~     peculiar anatomic organization mainly characterized by sluggish circulation and relative~     local hypoxia. VOCs combined with marrow hyperplasia and inflammation has been suggested to~     contribute to the development of sickle bone disease (SBD). Recently, it has been proposed a~     possible role of vitamin D deficiency in SBD, which appears to be subordinated to the primary~     defect in bone homeostasis. In a humanized mouse model for SCD, we recently reported that SBD~     is due to imbalance between osteoblast/osteoclast activity induced by recurrent VOCs. In~     addition, we show that zoledronic acid prevents bone impairment related to SCD, reducing~     osteoclast activity and improving osteoblast performance.~   "
45436|NCT02972125|"~     This is a study designed to demonstrate the Bioequivalence between Lacosamide (LCM) Tablet~     and Dry Syrup in Healthy Male Japanese Subjects~   "
45437|NCT02972112|"~     Women in their 3rd trimester, represent a unique segment of the tokophobic population. In~     these cases help is needed within a very short and limited period of time. To date, no~     specific treatment targets this population in order to ameliorate the anxiety and to provide~     these women and their newborns with better obstetric and psychiatric outcomes. The present~     study investigates an accessible individual two session intervention conducted by midwives~     skilled in CBT (cognitive behavioral therapy) . This intervention is designed to enable~     stronger emotional regulation and increase of their capacity to accept unexpected changes~     during labor and feelings of control. The investigators expect this psychological adjustment~     to lead to a better course of delivery, less interventions including caesarian sections, and~     subjective birth experience.~   "
45443|NCT02972034|"~     This study will evaluate the safety, tolerability and preliminary efficacy of MK-8353 when~     administered in combination with pembrolizumab (MK-3475). There are two parts in this study:~     Part 1 will be dose escalation and confirmation, and Part 2 will be a cohort expansion. In~     Part 1, the recommended phase II dose (RP2D) of MK-8353 in combination with a fixed dose of~     pembrolizumab in participants with advanced malignancies will be identified and confirmed.~     Participants will be initially enrolled to receive MK-8353 at 350 mg twice a day (BID) in~     combination with pembrolizumab at a fixed dose of 200 mg on Day 1 of each 3-week cycle (Q3W)~     for up to 24 months of treatment. In Part 2, participants with advanced colorectal cancer~     (CRC) who received at least one and up to five prior lines of therapy will be enrolled at the~     RP2D in the expansion cohort to further evaluate safety and efficacy.~      The protocol has been amended to lower the starting doses of MK-8353 in combination with~     pembrolizumab. In addition, 3 arms have been added: one in which MK-8353 will be administered~     continuously once a day (QD) in combination with pembrolizumab, one optional arm in which~     MK-8353 will be administered 1 week on/1 week off QD in combination with pembrolizumab and~     one optional arm in which participants undergo a MK-8353 QD run-in period prior to starting~     combination therapy with pembrolizumab.~   "
45444|NCT02972021|"~     Chronic respiratory insufficiency in patients with advanced disease to the late treatment~     depends mainly on mechanical ventilation and other high intensity respiratory support~     therapy. Strengthen the stability of chronic respiratory insufficiency intervention can~     reduce the frequency and extent of acute disease, saving medical resources.High-flow nasal~     cannula (HFNC), as a new non-invasive oxygen therapy system, has gradually become a weapon of~     respiratory support therapy. There is little research on the role of HFNC in oxygen therapy~     for chronic respiratory insufficiency.~      Our previous studies have found the potential value of HFNC in chronic respiratory~     insufficiency. The aim of this project is to promote the use of HFNC in the t reatment of~     chronic respiratory insufficiency in HFRS in Shanghai first, second and third grade hospitals~     in an effort to confirm that HFNC can improve the prognosis of patients with chronic~     respiratory insufficiency compared with nasal oxygen therapy.~   "
45445|NCT02972008|"~     Over the past ten years, the number of endovascular procedures has increased by 5% per year~     in Europe with the development of interventional cardiology, such as percutaneous coronary~     angioplasty, aortic valve replacements (TAVR), and vascular endoprosthesis.~      The neurological lesions detected on cerebral MRI caused by these endovascular procedures are~     frequent with an incidence of about 30-70%. These events, although subclinical, have an~     impact on morbidity and mortality and especially on long-term cognitive decline.~      TAVR is the reference treatment for symptomatic elderly patients with stenosis of the aortic~     valve, considered by a multidisciplinary Heart Team as at high surgical risk due to~     comorbidities, age and high perioperative risk scores ( Euroscore 2 and STS scores). Despite~     the net clinical benefit, an increase of silent neurological events was detected on~     post-procedural cerebral MRI with an incidence of approximately 70%.~      The epigenetic involvement in the occurrence of ischemic cerebral lesions is still largely~     unknown. Epigenetic mechanisms, such as DNA methylation, can be associated with aging~     processes and modulate the risk of developing cerebrovascular pathologies. They are likely to~     provide new biomarkers that predict the risk of brain damage.~      Hypomethylation of leukocyte DNA is directly related to atherosclerosis in humans. This~     hypomethylation of DNA would represent an easily measurable marker reflecting the presence~     and progression of atherosclerosis. Because atherosclerotic lesions often precede the~     clinical manifestation of ischemic cardiovascular disease, such as ischemic heart disease and~     stroke, DNA hypomethylation could be used to identify individuals at risk for cerebrovascular~     events.~      The investigator hypothesize that hypomethylation of leukocyte DNA can predict the risk of~     developing new ischemic brain lesions especially after a TAVI procedure.~   "
45446|NCT02971995|"~     Prostate cancer is the first cancer in humans (25%). The most widely used tracer in oncology,~     the 18-Fluoro DeoxyGlucose does not allow the study of prostatic neoplasia. On the other~     hand, Choline, which is an amino alcohol, is involved in the synthesis of cell membranes and~     has an affinity for prostate cells. Its concentration is directly proportional to cell~     proliferation. The analogue of choline has the advantage of having a rapid and stable~     accumulation over time in cancer cells, with a rapid urinary excretion (4 minutes after~     injection).~      The goal of this study is to assess the feasibility and the accuracy for targeting image~     guided prostate biopsy to detect prostate cancer after Imaging fusion of choline-PET/CT~     compared to 1.5T multiparametric magnetic resonance imaging (mpMRI) with 3D-transrectal~     ultrasound (TRUS) .~   "
45447|NCT02971982|"~     Patients will receive RCD or PCD combination as induction treatment followed by rituximab or~     velcade maintenance therapy, as the investigators try to compare the, very good partial~     remission (VGPR) rate, complete remission (CR) rates, Overall remission rate (MR+CR + VGPR +~     partial remission (PR) rate), major reaction rate (MRR, PR+VGPR+CR) at the end of the~     research.~   "
45448|NCT02971969|"~     A long-term follow-up study to evaluate the safety, tolerability, and efficacy of DTX101 in~     adult males with moderate/severe to severe hemophilia B.~   "
45449|NCT02971956|"~     This research study is studying a targeted therapy as a possible treatment for advanced~     esophageal cancer.~      The study intervention involved in this study is:~      -Pembrolizumab~   "
45450|NCT02971943|"~     To verify whether X-ray combined with MRI is able to carry out correct fracture~     classification and postoperative evaluation in patients with ankle fractures.~   "
45451|NCT02971930|"~     This study is to generate qualitative data to evaluate the impact of frequency of FVIII~     infusions on patients' satisfaction with treatment and their quality of life.~   "
45452|NCT02971917|"~     To validate the following theory: With TRUVIEW ART™ applied a detector's quantitative~     performance index, MTF(Modulation Transfer Function), is increased 20% or more. This is to~     examine the effect of the increased MTF index, whether it influences or not the interpreter's~     preference~   "
45453|NCT02971904|"~     An observational and prospective study involving about 30 healthy lactating mothers whose~     preterm infant(s) is/are hospitalized at Neonatal Intensive Care Unit after childbirth and~     who can provide enough maternal milk (3mL) to be analyzed from 4th day of admission until~     15th day of hospitalization or until discharge.~      Considering the lack of evidence related to breast milk nutritional composition from~     Brazilian lactating mothers of preterm infants; and also the utilization of human milk~     analyzer as a tool to optimize nutritional therapy and reach proper growth and development of~     preterm babies, this study aim to evaluate the nutritional composition of human milk from~     lactating mothers of preterm infant during the hospitalization, the infant grow and also the~     applicability of mid infrared (MIR) human milk analyzer (HMA) as a methodology.~   "
45454|NCT02971891|"~     To evaluate the efficacy and safety of six (6) weeks of once daily application of Furosemide~     Topical Gel 0.125% (CLS006) compared to vehicle in subjects ≥ 2 years of age with nongenital~     cutaneous common warts (verruca vulgaris).~   "
45455|NCT02971878|"~     Aim: To investigate the impact of antioxidants (acetyl-L-carnitine, N-acetyl-L-cysteine and~     a-lipoic acid) on embryo development and subsequently the clinical outcome. Including clinics~     using low oxygen and ambient air during embryo culture. Analysed with time-lapse system.~      Study media: G-TL with antioxidants. Control media: Same media without antioxidants. Type of~     study: Study comparing blastocyst development on the same cohort of oocytes using two~     different media, G-TL versus G-TL supplemented with antioxidants. Statistics based on an~     absolute increase in Good Quality Blastocysts on day 5 of 7%.~      Design: Multicentre prospective randomized sibling trial. Single blastocyst transfer.~     Superiority study Primary Endpoint: Good Quality Blastocysts on day 5 per allocated normally~     fertilized oocyte.~      Patients: Comparative embryo sibling study with 128 patients included.~   "
45456|NCT02971865|"~     Effects of manual medicine or cognitive behavioral therapy with chronic uncontrolled diabetes~     within a shared primary care visit. An evaluation of the effectiveness of manual therapy vs~     cognitive behavioral therapy (CBT) vs traditional primary care visit care is in need.~   "
45457|NCT02971852|"~     Hypnotic glove anesthesia is a hypnosis technique wherein the patient, following the~     suggestions of the hypnotherapist, is mentally capable to create a loss of sensation in areas~     of the hand that would be covered by a glove. We investigated the effects of hypnotic glove~     anesthesia on skin temperature measured by thermography.~   "
45458|NCT02971839|"~     This study will evaluate the efficacy and safety of CTP-656 in patients with cystic fibrosis~     (CF) who have a cystic fibrosis transmembrane conductance regulator (CFTR) gating mutation.~   "
45459|NCT02971826|"~     The last marketed thrombectomy devices, named stentretriever, permit a better and faster~     recanalization in patient with a stroke. The REVIVETM SE is a device designed to restore the~     brain perfusion in patient with an intracranial artery occlusion. The REVIVETM Se device is~     not widely use in Europe and in France. The objective of this study is to assess the interest~     of using this device in the standard care of ischemic stroke in the radiology unit of the~     hospital Pierre Wertheimer, Lyon. The medical care will not be modified but data will be~     collected in order to determine whether or not this device is useful for the practice of the~     radiology unit.~   "
45460|NCT02971813|"~     While cardiac rehabilitation (CR) has been shown to be effective at improving cardiovascular~     disease (CVD), participation is generally poor. For this reason, the current research, a~     prospective, randomized controlled pilot study, will evaluate the impact of a social media~     intervention on motivation for exercise and adherence to CR sessions. Participants will be~     randomly assigned to a Facebook™ group or an enhanced education comparison group. The~     intervention will include access to a private Facebook™ group in which participants will~     receive weekly educational posts, weekly provider support and have the opportunity to~     communicate with other cardiac rehabilitation patients. Patients in the comparison group will~     be given the same educational materials, but these will be supplied in handout form, or email~     if the patient is absent from cardiac rehabilitation. Participants will be asked to fill out~     a pre-post motivational questionnaire and the total number of sessions attended at the end of~     3 months will be tallied. This study is grounded in Self-Determination Theory (SDT) and~     utilizes the Behavioral Regulation in Exercise Questionnaire (BREQ-2), which is based on the~     SDT.~   "
45461|NCT02971800|"~     The primary objective is to describe the safety and efficacy of intravenous sodium~     fluorescein to visualize ureteral efflux during intraoperative cystoscopy after total~     laparoscopic hysterectomy. Secondary objective is to report on surgeon's satisfaction with~     the overall use of sodium fluorescein.~   "
45462|NCT02971787|"~     To investigate the influence of an increased salt intake (6 g/d for 14 days) on the relative~     abundance of gut lactobillus species in healthy men~   "
45463|NCT02971774|"~     The aim of the study consists in enriching knowledge of health professionals, on the~     functional difficulties encountered by hemiplegic patients outside the hospital, in~     particular on hobbies, going out with friends or family, work, daily life and the personal~     projects. Another objective is to evaluate the diversity of the attitudes and representations~     of the patients about their body damage. Lastly, the study seeks to develop a new grid of~     evaluation of the quality of life of the patients, which determines more fields of the~     existence significantly impacted by the hemiparesy, from the point of view of the patients.~     It is a question of improving the therapeutic care of the patients and to determine if~     various therapeutic approaches (occupational, pharmacological, surgical) have an impact on~     these various fields. The study will be based on qualitative data (interviews) and~     quantitative (questionnaires).~   "
45464|NCT02971761|"~     This phase II trial studies the side effects and how well pembrolizumab and enobosarm work in~     treating patients with androgen receptor positive triple negative breast cancer that has~     spread to other places in the body. Monoclonal antibodies, such as pembrolizumab, may~     interfere with the ability of tumor cells to grow and spread. Androgen can cause the growth~     of breast cancer cells. Hormone therapy using enobosarm may fight breast cancer by blocking~     the use of androgen by the tumor cells. Giving pembrolizumab and enobosarm may work better in~     treating patients with androgen receptor positive triple negative breast cancer.~   "
45465|NCT02971748|"~     You are being asked to take part in this study because you have inflammatory breast cancer~     (IBC) that did not respond completely to chemotherapy.~      The goal of this clinical research study is to learn if pembrolizumab in combination with~     standard hormone therapy can help to control and prevent IBC. The safety of this drug~     combination will also be studied.~      This is an investigational study. Pembrolizumab is FDA approved and commercially available~     for the treatment of metastatic melanoma. Its use in patients with IBC in combination with~     standard hormonal therapy is considered investigational.~      The study doctor can explain how the study drugs are designed to work.~      Up to 37 participants will be enrolled in this study. All will take part at MD Anderson.~   "
45484|NCT02971501|"~     This randomized phase II trial studies how well osimertinib with or without bevacizumab works~     in treating patients with EGFR positive non-small cell lung cancer that has spread to the~     brain. Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Monoclonal antibodies, such as bevacizumab, may interfere with the ability~     of tumor cells to grow and spread. Giving osimertinib with or without bevacizumab may work~     better in treating patients with non-small cell lung cancer.~   "
45466|NCT02971735|"~     New designs of 6-year undergraduate medical education (UME) in Taiwan mainly include (1)~     integral curricula of body organ system, (2) multiple methods of clinical teaching and~     assessment, and (3) generalism in UME. Accompany with decreasing educational hours in the~     classrooms and hospital, essential but minor components of primary healthcare such as~     ophthalmology and otolaryngology-head and neck surgery (ORL-HNS) is disproportionately~     under-represented in UME. Novel medical education stresses on enabling self-directory~     learning and increasing learning hours outside the classrooms. Accordingly, we hypothesize~     that innovations in educational technology can enhance the learning outcomes of ORL-HNS. This~     study is aimed to determine whether mobile technology in e-learning (M-TEL) is an effective~     tool for the instruction of ORL-HNS and to compare effects of different cognitive styles on~     learning outcomes of M-TEL with various modules of medical education. This is a randomized~     controlled trial. We will recruit 60 UME students without previous training in ORL-HNS to~     undergo the Group Embedded Figures Test to determine their cognitive styles such as field~     dependence or field-independence. After blinded randomization, students are instructed on two~     modules of emergent ORL-HNS disorders, using either a standard e-learning of text-figure~     Power Point show or an interactive multimedia module. Subjects are evaluated on emergent~     ORL-HNS disorders using text-based assessment and multimedia assessment take place prior to~     and following instruction. After 7 days later, they will be assessed using global~     satisfaction score and AttrakDiff2 questionnaire. We anticipate that this study can confirm~     M-TEL can enhance the efficiency of the instruction of ORL-HNS and understand differences in~     learning outcomes of M-TEL with various modules of medical education between field dependence~     and filed independence using this platform.~   "
45467|NCT02971722|"~     JY09，is a recombinant glucagon-like peptide-1 (GLP-1) receptor agonist,constructed with~     Exendin-4 and human Immunoglobulin G2 (IgG2) Fc fragment.Preclinical studies show that JY09~     exhibit the expected GLP-1-mediated pharmacological effects on insulin secretion,glucose~     covering and islet cell recovering,as well as good tolerance and safety.JY09 has been~     approved by China food and drug administration(CFDA) to enter the clinical research~     stage(Grant number 2016L04254).This study is designed to assess the~     safety,tolerability,pharmacokinetics,pharmacodynamics and potential immunogenicity of JY09 in~     healthy Chinese volunteers.~   "
45468|NCT02971709|"~     Use of shade when outdoors is recommended by health authorities worldwide to reduce overall~     exposure to ultraviolet radiation. However, expensive physical environment changes are often~     required to provide shade and may be effective only when health education has created a~     social environment that motivate shade use. A multi-national research team will explore the~     use of built shade in passive recreation areas within public parks and compare use of built~     shade between the United States and Australia. The specific aims of the project are to: a)~     introduce built shade structures (i.e., shade sails) in public parks in Denver and Melbourne;~     b) compare the use of passive recreation areas with and without built shade; c) compare the~     change in use of the passive recreation areas in Denver and Melbourne after introduction of~     built shade, and d) examine the relationship among social environment and physical features~     of the environment and built shade.~   "
45469|NCT02971696|"~     The aim of the study is to evaluate the efficacy of sorafenib, compared to the best~     supportive care (BSC), in two cohorts of patients who presented with advanced hepatocellular~     carcinoma (HCC) based on etiology of hepatitis C virus.~   "
45470|NCT02971683|"~     Trial to Evaluate the Efficacy and Safety of Abatacept subcutaneous (SC) in Combination With~     Standard Therapy Compared to Standard Therapy Alone in Improving Disease Activity in Adults~     With Active Idiopathic Inflammatory Myopathy~   "
45471|NCT02971670|"~     Toxic Shock Syndrome (TSS) a severe condition with high morbidity and mortality results from~     the hosts overwhelming inflammatory response and cytokine storm. Staphylococcal superantigen~     toxins are the main causative agents. Toxic shock syndrome toxin (TSST-1) being responsible~     for almost all of menstruation associated and more than 50% of all other cases. There is no~     specific therapy. The Phase I study BioMed0713 demonstrated the safety and tolerability of~     the BioMed recombinant toxic shock syndrome toxin (rTSST-1) Variant Vaccine in healthy~     adults.~      The aim of this amendment is to demonstrate prolonged safety of the BioMed rTSST-1 Variant~     Vaccine and to assess persistence of antibodies generated in participants. The second aim of~     the study is to assess boosterability of the BioMed rTSST-1 Variant Vaccine.~   "
45472|NCT02971657|"~     This was a prospective study performed between November 2011 and September 2013. Patients~     with a confirmed S. aureus infection after fracture fixation or prosthetic joint infection~     were included. Exclusion criteria included infections involving external fixation pins,~     infections without any implanted hardware and culture positive patients not displaying any~     clinical sign of infection. The following surgical parameters were documented: affected bone~     or joint; type of implant; time between implantation of the device and onset of symptoms.~     Personal characteristics and patients`health status were also documented. Any revision~     surgeries involving the site of interest and all isolated pathogens were recorded throughout~     the course of treatment and follow-up.~      A follow up examination was performed an average of 23 months after discharge. Primary~     outcome at follow up was cure. Cure was defined by the authors as: missing local (at site of~     interest) or systemic signs of infection, terminated surgical and systemic therapy and~     restoration of joint or limb function.~      At the first surgical procedure after enrolment, at least four deep bone biopsies were taken~     from the interface between implant and affected bone. Identification and antibiotic~     susceptibility testing of all growth was performed. Multi-drug-resistance (MDR) was defined~     according to the definitions of the European Committee of Antimicrobial Susceptibility~     Testing (EUCAST). Biofilm formation was analysed and quantified in microtitre plate assays~     according to protocol of Stepanovic et al.(see references).~   "
45473|NCT02971644|"~     To investigate whether implantation of cobalt alloy pedicle screws is effective in treating~     severe kyphosis deformity in spinal tuberculosis, and to determine the factors that are~     likely to have influenced the curative effects.~   "
45483|NCT02971514|"~     This randomized controlled crossover trial conducted on 25 dental students. in the~     preliminary session each volunteer was given a toothbrush(Trisa, soft, Switzerland) and~     toothpaste(Pooneh, Iran) and Dental Floss( Mina, Iran)to use during the study, and they were~     instructed the proper techniques of brushing and flossing.The study was performed in two~     treatment sessions and a 48 hour washout period. They passed through the sessions in a~     randomized sequence. After prophylaxis with rubber cup, they were asked to discontinue all~     oral hygiene for 24 hour. At the first session , they flossed first followed by brushing~     (floss-brush group) and at the other session they used dental floss after brushing~     (brush-floss group) . At each session, before and after brushing and flossing , Dental plaque~     reduction was assessed using Rustogi Modified Navi Plaque Index. Interdental plaque was~     collected for measuring fluoride. Differences between the two groups were analyzed with mixed~     model test.~   "
45474|NCT02971631|"~     Patients who have undergone gastrectomy (removal of the stomach) to treat or prevent cancer~     are known to have a significantly reduced quality of life. To date, there is very little~     information on the physiological causes of this. The investigators suspect that~     overproduction of a hormone (chemical) called glucagon like peptide-1 (GLP-1) released by the~     lining of the gut may play a role in the reduced appetite, weight loss and low blood sugar~     symptoms seen in this group. To investigate this, the investigators will study the response~     of 16 patients who have previously had a gastrectomy to a glucose drink, and a meal, while~     receiving an infusion of a specific blocker of GLP-1 or placebo. The investigators will~     examine the levels of sugar and associated hormones in the blood, food consumption and food~     reward behaviour using standard tools.~      Participants will be invited to attend the Clinical Research Facility at Addenbrooke's~     Hospital for a screening visit, and two whole day study visits. The study has been designed~     to assess the role of overproduction of GLP-1 by completely blocking its actions, rather than~     assess the use of the blocking compound as a medication, and is therefore regarded as a~     physiological study, not a clinical trial.~      The goal of this study is to demonstrate the magnitude of effect of GLP-1 on blood sugar and~     appetite derangement in patients who have had a gastrectomy. This will guide future work on~     the development of novel treatment paradigms for the post-gastrectomy patient group.~   "
45475|NCT02971618|"~     The study will retrospectively collect clinical variables and socio-demographic data from~     medical records of patients with T2DM initiating treatment with dapagliflozin after the~     previous failure/inefficiency of other treatment options (defined as non-achievement of~     target Hb1Ac) and according to the officially approved indication as per instruction for the~     use of medicinal product.~      It is expected that the best available data regarding clinical variables and patient~     socio-demographic profiled will be collected from the patient medical records at up to 40~     major Russian outpatient clinics/centers specialized in the treatment and management of T2DM~     patients.~      There are 2 time points:~        -  Baseline data: baseline data are defined as data available within 3 months prior to the~          first dose of dapagliflozin. In case of presence of multiple data values within baseline~          period the most recent pre-dose value will be selected~        -  Follow-up data: any post-baseline data will be considered as follow-up but the primary~          analysis will be focused on data available at 6 plus/minus 3 months after the initiation~          of dapagliflozin. In case of discontinuation dapagliflozin, data will be collected at~          routine visit within 3-month time frame after the last dose~   "
45476|NCT02971605|"~     The proposed pilot study will assess whether ingestion of a classic hallucinogen (psilocybin)~     leads to changes in emotion processing and neural circuitry that may predict repeated~     self-administration of this drug and underlie an atypical mechanism of abuse liability, which~     may vitally contribute to the understanding of the potential for abuse and the underlying~     mechanisms supporting abuse of classic hallucinogens.~   "
45477|NCT02971592|"~     This study will assess the therapeutic effect of MDcure® device. MDcure® is an FDA Class 1~     listed medical device, produced to ISO-13485 standards, that delivers extremely low intensity~     (nano Tesla; 10-9) and low frequencies (1-100 Hertz) electromagnetic fields (EMF) intended to~     reduce muscular aches and pains particularly of the lower back.~      assessing the reduction of lower back pain. Half of participants will receive the MDcure~     device, while the other half will receive a mock device.~   "
45478|NCT02971579|"~     This is a prospective observational longitudinal study~      Aim of the study is to collect information:~        -  on the organization models of the Endoscopic Units performing ERCP in Italy~        -  on the previous and/or ongoing training of the endoscopists performing ERCP~        -  on the clinical characteristics of patients undergoing ERCP in Italy as well as on the~          outcome~   "
45479|NCT02971566|"~     Antenatal absent or reversed end-diastolic flow (AREDF) velocity through the umbilical~     arteries places preterm infants at significant risk for developing gastrointestinal~     complications, such as feeding intolerance, necrotizing enterocolitis or spontaneous~     intestinal perforation. Due to the fear of the aforementioned conditions, the establishment~     of adequate enteral feeds is frequently hampered in this population. Previous postnatal~     Doppler studies have shown that AREDF preterm infants who later developed feeding intolerance~     have a decreased blood flow velocity in the superior mesenteric artery in response to the~     first enteral feed; to date, however, it is not known whether this hemodynamic impairment~     persists over time, or if it is associated with reduced splanchnic oxygenation and perfusion,~     monitored by Near-infrared spectroscopy (NIRS).~      This observational prospective study aims:~        -  to assess the patterns of abdominal oxygenation and perfusion in response to enteral~          feeds in AREDF preterm infants at different phases of enteral feeding establishment;~        -  to evaluate a possible correlation with the development of gastrointestinal~          complications.~   "
45480|NCT02971553|"~     Each year, almost 3 million newborn babies die within their first month of life, often as a~     consequence of labour complications. Approximately 5% of newborns will not start breathing at~     birth and need immediate help. The optimal ventilation strategy with liquid-filled lungs has~     not been determined. Animal studies suggest that assisted ventilation with positive end~     expiratory pressure (PEEP) improves the aeration of liquid-filled lungs leading to more rapid~     recovery. However, no large human clinical studies have investigated the clinical responses~     to assisted ventilation with PEEP in asphyxiated newborns.~   "
45481|NCT02971540|"~     The aim of this randomized trial is to assess the efficacy of analgesia for lumbar discectomy~     and compare Numerical Rating Scale (NRS) with Surgical Pleth Index (SPI) for monitoring pain~     perception postoperatively.~      Patients received either preemptive local tissue infiltration at surgical site using either~     0,2% ropivacaine with fentanyl or 0,2% bupivacaine with fenthanyl or preemptive intravenous~     infusion using metamizole and tramadol.~   "
45482|NCT02971527|"~     The purpose of this study is to examine whether ultrasound bone strength device (Model~     Number: Oste-scan 500A) is effective and safe in measuring calcaneal bone strength index of~     human subjects, compared with a listed, similar device (Model Number: SONOST3000).~   "
45534|NCT02970851|"~     The purpose of this study is to assess the effect of bosentan on the myocardial metabolism~     and the dependent endothelial coronary vasomotoricity in patients presenting a PAH.~      Hypothesis : Bosentan may improve right ventricular function by decreasing myocardial stress~     and glucose metabolism. Patients may benefit from images with 18F-FDG PET / CT and 82Rb PET /~     CT for an earlier assessment and optimal management of PAH.~   "
45485|NCT02971488|"~     Screening, diagnosis and treatment of HCV in PWID, should be part of a harm reduction~     strategy. Treatment of HCV infected PWID should be delivered in a multidisciplinary care~     setting with services to reduce the risk of reinfection and for management of the common~     social and psychiatric comorbidities in this population. More frequent diagnosis, new methods~     that prevent loss of tracking, and access to antiviral treatment are all strategies that must~     be implemented jointly if the prevalence of HCV infection in our setting is to be reduced.~   "
45486|NCT02971475|"~     The study wants to compare ESWL alone with ESWL and endoscopic drainage of the MPD for~     treatment of pain in chronic pancreatitis.~   "
45487|NCT02971462|"~     The purpose of this study is to investigate whether remote ischemic conditioning(RIC) would~     reduce the stroke risk of patients with symptomatic vertebrobasilar lesion of~     atherosclerosis,then we would observe the haemodynamics and plasma biomarkers changes.~   "
45488|NCT02971449|"~     This study compares the traditional, didactic method of training Ugandan community health~     workers with training using tablets in pneumonia management, a common, life-threatening~     illness in children in rural areas.~   "
45489|NCT02971436|"~     This study will investigate the efficacy of the FPH modified positive airway pressure (PAP)~     device with or without SensAwake; and with different pressure support in OSA participants; in~     both an in-home and in-lab environment. Comfort, compliance and the accuracy of the pressure~     delivery will also be evaluated. The FPH device will be compared to a market released~     product.~   "
45490|NCT02971423|"~     This research project is being conducted to look at the safety, tolerability, and~     pharmacokinetics (PK; how the human body processes a substance) of ETX2514 when given to~     healthy volunteers intravenously as a single dose, and when given as multiple intravenous~     doses for up to 8 consecutive days.~      As it is anticipated that ETX2514 could be used as a treatment for Acinetobacter baumannii (a~     type of bacteria) infections, this project will also look at whether ETX2514 will interact~     with the current treatments for these infections when they are administered at the same time.~   "
45491|NCT02971410|"~     This pilot clinical trial studies how well simvastatin works in overcoming chemotherapy~     resistance in patients with multiple myeloma that has come back or does not respond to~     treatment. Simvastatin may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth.~   "
45492|NCT02971397|"~     This pilot clinical trial studies the side effects of cytarabine and daunorubicin~     hydrochloride and to see how well they work in treating patients with newly diagnosed acute~     myeloid leukemia. Drugs used in chemotherapy, such as cytarabine and daunorubicin~     hydrochloride, work in different ways to stop the growth of cancer cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading, and may be~     safer for the heart.~   "
45493|NCT02971384|"~     Aim of this study is to investigate efficacy and safety of Echinaforce Junior Tablets (250mg)~     in comparison with Vitamin C tablets in the prevention of acute viral respiratory tract~     infections.~   "
45494|NCT02971371|"~     Many studies have demonstrated the usefulness of repetitive task practice by using robotic~     devices, including Lokomat, for the treatment of lower limb paresis. Virtual reality (VR) has~     proved to be a valuable tool to improve neurorehabilitation training. Our pilot randomized~     clinical trial aimed at evaluating the correlation between the modifications of brain~     oscillations during a VR neurorehabilitative training of gait and the motor function recovery~     in patients with chronic stroke.~      Twenty-four patients suffering from a first unilateral ischemic stroke in the chronic phase~     were randomized into two groups. One group performed 40 sessions of Lokomat with VR (RAGT+VR)~     whereas the other group underwent Lokomat without VR (RAGT-VR). Outcomes (clinical,~     kinematic, and event-related synchronization, ERS, and desynchronization, ERD, at the EEG)~     were measured before and after the robotic intervention.~      The robotic-based rehabilitation combined with VR could be associated with improvements in~     several measurements of lower limb function, gait, and balance in patient with chronic~     hemiparesis. Moreover, ERS/ERD analysis can be proposed as a tool to monitor motor~     performance and to develop non-invasive brain-computer interfaces controlling robotic~     devices.~   "
45495|NCT02971358|"~     Prostate cancer is the most common non-skin cancer diagnosed among men and the second leading~     cause of male cancer deaths in the United States. In 2013, it is estimated that 29,270 men~     have died from prostate cancer. Although radiation and surgery are quite effective for~     localized disease, there is no effective cure for men who present with metastatic prostate~     cancer as the 5-year relative survival rate is only 28%.~      Currently, androgen deprivation therapy (ADT) via medical or surgical castration is the~     standard first-line therapy in men with metastatic disease but castration-recurrent prostate~     cancer (CRPC) eventually emerges with a median time of 18-24 months. Once CRPC develops,~     secondary hormonal manipulation, chemotherapy, and immunotherapy are marginally effective.~      Given the dismal prognosis of metastatic prostate cancer, new ideas and novel approaches must~     be explored to improve the clinical outcome. In this regard, recently emerging data suggest~     that local tumor control may enhance the effectiveness of subsequent systemic therapies.~     Therefore, in this proposal, the investigators have designed a Phase I/II study in which they~     will prospectively evaluate the safety and feasibility of cytoreductive prostatectomy in men~     with newly diagnosed mPCa.~   "
45496|NCT02971345|"~     It is a prospective and multi-center clinical research in China to compare the efficacy,~     safety and related impact factors between TACE alone and endovascular brachytherapy combined~     with stent placement and TACE for HCC with main portal vein tumor thrombus.~   "
45497|NCT02971332|"~     Obstructed defecation syndrome (ODS) is a widespread and disabling syndrome. With this study~     the investigators want to evaluate the long term results of Stapled Transanal Rectal~     Resection (STARR) performed with Contour Transtar device in the treatment of ODS. A~     re-evaluation of 113 patients subjected to STARR from June 2007 to January 2010 was~     conducted.~   "
45498|NCT02971319|"~     This study aims to assess the technical performance of Tc-99m tetrofosmin SPECT as compared~     to F-18 FDG PET for the differentiation of radiation necrosis from glioma relapse and to~     obtain estimates of diagnostic accuracy for Tc-99m tetrofosmin SPECT and F-18 FDG PET in an~     intra-individual comparison.~   "
45535|NCT02970838|"~     To evaluate a standardized weight-loss program as treatment option for obesity and type 2~     diabetes, changes in body composition and metabolic control are investigated in obese~     patients with diabetes.~   "
45499|NCT02971306|"~     Alcoholic hepatitis is related to very high mortality rate. About 40% of the patients are~     died within first 6 months after the detection of the clinical syndrome. Therefore, it is~     very essential for proper diagnosis and early treatment. In response to acute or chronic~     liver damage, bone marrow derived stem cells can spontaneously populate liver and~     differentiate into hepatic cells. Animal and human studies suggested that injured hepatocyte~     may be replaced by pluripotent bone marrow cells. However, this hepatocyte repopulation is~     highly dependent on varieties of liver injury and therapeutic conditions6. The studies has~     suggested Granulocyte-colony stimulating factors (G-CSF) can regenerate hepatocyte by fusing~     with hematopoietic cells, thereby enhancing the liver histology and survival rate.~      G-CSF is a cytokine capable to regulate a number of functions in neutrophils. In three recent~     studies mobilization of bone marrow stem cells induced by G-CSF was observed in patients with~     alcoholic hepatitis. In two of this studies there was a survival benefit with the use of~     G-CSF.~      Alcoholism leads to decrease in endogenous antioxidant potential. Alcoholic liver disease~     (ALD) patients show low endogenous antioxidants. Chronic ethanol consumption cause selective~     deficiency in the availability of reduced glutathione (GSH) in mitochondria has been~     reported. This is due to impaired functioning of GSH transporter from cytosol to~     mitochondrial matrix. The effect on glutathione replenishing potential by N-acetyl cysteine~     (NAC) can be used to reduce oxidative stress, which also has excellent safety profile.~     Therefore, NAC can be used for severe alcoholic hepatitis treatment due to its therapeutic~     potential factor. NAC also inhibit apoptosis and pro-inflammatory cytokine production. In a~     study high doses of intravenous N-acetyl cysteine therapy for 14 days conferred neither~     survival benefits nor early biological improvement in severe alcoholic hepatitis patients~     with adequate nutritional support.However, these results must be viewed with caution, since~     the study suffered from a lack of power. In a recent study, NAC and corticosteroids~     combination therapy benefits among patients with severe acute alcoholic hepatitis in 1 month~     survival, although the final outcome at 6 month survival was not improved. There are no~     studies on the use of combination therapy of NAC plus G-CSF in patient with severe alcoholic~     hepatitis.~      Therefore we plan to study the safety and efficacy of combination therapy of G-CSF and NAC in~     the patients with alcoholic hepatitis.~   "
45500|NCT02971293|"~     This is a study to evaluate the effects of AZD8871 in patients with COPD. Adult male or~     female patients with moderate to severe COPD, who agree to be in this study, will receive 3~     treatments, i.e. 2 different doses of AZD8871 and placebo (dummy medication containing no~     drug) at once a day for 2 weeks, in a random order. To make the comparison between AZD8871~     and placebo as fair as possible, this study is double blinded. This means that neither~     patient nor the study doctor will know in which order the 3 treatments will be given. This~     study will include patients who are between 40 and 80 years of age. In total there will be 42~     patients participating in this study at two study centers in the United Kingdom and Germany.~     The study will have a total of 12 visits for each patient spanning for a period of 4 to 6~     months. The study is anticipated to run for approximately 8 months and should not exceed 10~     months.~   "
45501|NCT02971280|"~     Exposure to heavy metals may interfere with basic cellular functions, including DNA~     synthesis.~      The aim of the study is to correlate heavy metals concentration in body fluids of~     reproductive importance and IVF outcome.~   "
45502|NCT02971267|"~     Follow-up of a cohort of inflammatory cardiomyopathy patients (suspected or validated~     inflammatory cardiomyopathy) recruited at baseline by the SFB-TR19 project. Standardized~     protocols will be used for the assessment of medical history and examinations, laboratory~     biomarkers, and the collection of various biomaterials for biobanking purposes.~   "
45503|NCT02971254|"~     Recovery of the cognitive functions and recovery features after general anaesthesia in Down~     syndrome patients. A comparison of Sevoflurane and Desflurane.~   "
45504|NCT02971241|"~     The primary purpose of the study is to understand the potential of mobile computing~     technology to improve chronic disease self-management, quality of life, and health outcomes~     of older adults to prevent or alleviate future disabilities. Thus, the study will design,~     develop, and test an intervention to motivate and train seniors to use the technology, and~     conduct a trial to evaluate its effect. This innovative intervention will deploy young~     generation (age 18 to 30) volunteers to provide mobile technology training, access, and~     support to older adults (aged 55 and above) with type 2 diabetes in Taiwan. Hence, a~     secondary purpose of the study is to understand the effects of the volunteering experience on~     the values, characters, and health awareness in the young generation. This program, called~     the Intergenerational Mobile Technology Opportunities Program (IMTOP), will help older adults~     with type 2 diabetes acquire skills to use the Internet, World Wide Web (WWW), applications~     (or apps), and basic computing via mobile tablet devices. These skills will give~     participants access to resources and tools to improve health and mental health, reduce social~     isolation, and increase social engagement, as well as meet their individual life goals. The~     course will use young volunteers to deliver the tablet training. The training course will be~     offered as small-group sessions over an 8-week period (for up to 16 hours of training) at a~     hospital site, plus young volunteers' technical support and problem solving for up to 4 weeks~     after the training sessions are completed. Using college students to serve as volunteer~     trainers for teaching mobile technology, the research also aims to understand not only how~     the intergenerational interactions help the older adults learn the technology and improve~     health, but also how they make impacts on the young adults' skills and experiences that will~     help them in their future careers and in the development of their characters. This research~     study will recruit three hundred fifty (350) patients from the collaborating hospitals,~     including two hundred fifty (250) patients from Taipei Tzu Chi Hospital and one hundred (100)~     patients from Hualien Tzu Chi Hospital. An estimate of 140 students in colleges and~     universities in Taiwan (100 volunteers in Taipei hospital and 40 volunteers in Hualien~     hospital) between the age of 18 and 30 will be recruited to serve as volunteer instructors to~     teach older adults to use tablets and to provide technical support services. Moreover,~     another group of 140 young adults, also age 18 to 30, will be recruited from universities to~     serve as the comparison group to the volunteers in intervention group. The course objectives~     are to guide older patients with Type 2 diabetes to use technology to obtain diabetes-related~     medical information, learn to record and control their physiological data via technology,~     promote intergenerational communication, enhance the convenience in life, and improve social~     life and mental health through technology tools such as the Internet, social media, online~     health education resources, instructional videos and so on. It is hoped to further slow down~     degradation, promote health and prolong life.~   "
45505|NCT02971228|"~     The purpose of this study is to determine whether the Bionic Pancreas with ZP4207~     (dasiglucagon*) is feasible to improve glycemic control in adults with type 1 diabetes~     mellitus.~      *dasiglucagon is the proposed International Nonproprietary Name (pINN) for ZP4207~   "
45506|NCT02971215|"~     The purpose of this study is to assess the effectiveness of high intensity laser therapy in~     the treatment of subacromial impingement syndrome.~   "
45507|NCT02971202|"~     The purpose of this study is to determine the key factors influencing insulin sensitivity in~     type 1 diabetes (T1DM) and maturity onset diabetes of the young, type 2 (MODY2).~      Our study tests the hypothesis that decreased insulin sensitivity is primarily driven by~     chronically elevated insulin levels in the blood rather than chronic elevations in blood~     sugar.~   "
45508|NCT02971189|"~     A prospective, single-arm, non-randomised study to evaluate the Librata device performance~     and acute safety in performing global endometrial ablation in pre-menopausal women with heavy~     menstrual bleeding.~   "
45509|NCT02971176|"~     The purpose of this study is to compare the diagnostic accuracy and complication rate between~     low-dose computed tomography-guided and standard-dose computed tomography-guided lung biopsy.~   "
45536|NCT02970825|"~     The investigators perform a prospective, randomized, clinical study involving students in~     education with mood disorders and randomized to an intensive exercise program or a control~     relaxation activity.~   "
45537|NCT02970812|"~     This randomized, placebo-controlled, double-blind, controlled study was designed to~     investigate the efficacy of electrical muscle simulation (EMS) for treatment of waist~     circumference (WC) reduction in abdominal obese adults.~      60 patients with abdominal obese, man with WC > 90 cm and woman with WC > 80 cm, received EMS~     as experimental group (EG) or transcutaneous electrical nerve stimulation (TENS) as control~     group (CG) 5 times a week for 12 weeks.~   "
45510|NCT02971163|"~     Syncope, or transient loss of consciousness/fainting, is a common emergency department (ED)~     complaint responsible for over 1 million ED visits yearly. Potential causes include benign~     conditions such as dehydration or vaso-vagal syncope. Rarely, syncope is the result of~     serious cardiac conditions. In older patients without a clear cause of syncope hospital~     admission is frequently initiated at very low risk thresholds, though there is little~     evidence that these admissions improve patient outcomes. These decisions are often made~     without significant patient input or discussion of reasonable alternatives. In this~     situation, a patient's values, preferences, and particular circumstances should be taken into~     account. This mutualistic approach to clinical management is referred to as Shared~     Decision-Making. Shared Decision-Making (SDM) is a joint process of choice selection between~     providers and patients in clinical scenarios where multiple reasonable management options~     exist. To improve syncope emergency care, the researchers can leverage recent advances in~     risk stratification to engage patients in SDM and deliver superior, patient-centered care.~      This study will provide the groundwork for a larger, randomized controlled trial evaluating~     the effects of the decision aid for management of low-risk syncope.~   "
45511|NCT02971150|"~     The purpose of this pilot study is to obtain information about older Veterans' preferences~     for treatment of depression and insomnia and to pilot test the feasibility and clinical~     effect of Brief Behavioral Treatment for Insomnia (BBTI) BBTI for older Veterans living with~     Treatment Resistant Depression (TRD) and insomnia.~   "
45512|NCT02971137|"~     This purpose of this study is to test the telephone delivery of a cognitive behavioral~     intervention (CBI), for smoking cessation among Veteran smokers with chronic pain.~   "
45513|NCT02971124|"~     To assess cognitive performance by means of the game of Solitaire. In this study, the~     investigators want to define relevant game metrics, when playing Solitaire, that may be~     indicative of cognitive performance.~   "
45514|NCT02971111|"~     The purpose of this study is to analyze occurence of bleeding complications during invasive~     procedures in septic patients with normal tromboelastometry results despite prolonged~     standard coagulation tests results~   "
45515|NCT02971098|"~     The over-65 population is not only increasing at an alarming rate, but because six out of 10~     will be managing more than one chronic condition by 2030, they will make up a much greater~     proportion of hospitalizations than ever before. Hospitalizations for disease, injury, and/or~     surgery in this group are likely to impair physical mobility and, therefore, the older adults~     capacity to be physically active both during hospitalization and beyond. The resulting~     sedentary lifestyle is likely to be accepted as the new normal, ultimately increasing the~     risk of skeletal muscle and metabolic dysfunction (e.g. impaired glucose disposal, insulin~     resistance). These devastating outcomes are neither inevitable nor necessary if prevented~     with an appropriate mechanism-based intervention.~      A novel mechanism that may contribute to physical inactivity-induced insulin resistance is~     accumulation of inflammation and ceramide within skeletal muscle. Of interest, increased~     skeletal muscle inflammation and ceramide has been tied to various metabolic disturbances~     such as diabetes and insulin resistance. However, it is currently unknown if skeletal muscle~     inflammation and ceramide are a key mechanism associated with insulin resistance due to~     physical inactivity in older adults.~   "
45516|NCT02971085|"~     In this study, the investigators aim to establish the prostate cancer active surveillance~     prospective cohort in our institution, and finally investigate the 5 year rates of~     reclassification during active surveillance as the primary endpoint of the current study.~   "
45517|NCT02971072|"~     The purpose of this study is to examine deficits in activation and motor patterns, as well as~     central drive in patients with rotator cuff tendinopathy. There are three specific aims: (1)~     determine the effect of acute pain relief on rotator cuff muscle activation in patients with~     rotator cuff tendinopathy, (2) determine the effect of exercise on rotator cuff muscle~     activation in patients with rotator cuff tendinopathy, and (3) compare rotator cuff muscle~     activation between patients with rotator cuff tendinopathy and healthy controls.~   "
45518|NCT02971059|"~     Currently there are insufficient published studies on amino acid requirements in the elderly.~     Phenylalanine is one of the indispensable amino acids. Low levels of phenylalanine has been~     observed in in the blood of older adults. It is due the increased uptake by the liver and~     intestine. This decreased levels of phenylalanine could lead to decreased skeletal muscle~     protein synthesis. Requirement for elderly individuals have been set based on studies~     conducted in younger adults hence may be inaccurate. The goal of this study is to directly~     measure the phenylalanine requirement of male and female elderly subjects over 65 years using~     the direct amino acid oxidation (DAAO) technique.~   "
45519|NCT02971046|"~     The fractional and absolute synthesis rates of GSH, an antioxidant that protects cells from~     damage, in the erythrocytes of healthy school-aged children in response to graded intakes of~     protein to determine if increasing the protein intake above the current recommended DRI~     produces increases in the GSH synthesis rates in erythrocytes of healthy school-aged~     children. Participants will consume specially formulated diets with varying protein levels.~   "
45538|NCT02970786|"~     The primary objective of the trial is to test the new radio tracer 68Ga-NODAGA-E[c(RGDyK)]2~     for PET imaging of angiogenesis. The tracer has the potential of identifying tumors with a~     high level of angiogenesis, which is one of the cancer hallmarks. Furthermore, the tracer can~     potentially be used in early response assessment to anti-angiogenic treatment.~      This is a first-in-man study to test the radio tracer in cancer patients. Safety,~     biodistribution and dosimetry will be evaluated by repeated PET imaging (10 minutes, 1 hour~     and 2 hours post injection).~   "
45548|NCT02970656|"~     This feasibility/pilot study has three purposes. First, the investigators will determine the~     feasibility of collecting saliva to measure stress biomarkers over three days at home in~     youth. Second, the investigators will conduct a pilot study of the Teens.Connect Internet~     program for youth with type 1 diabetes to determine whether changes in stress biomarkers~     associate with self-reported perceived stress and HbA1c. Third, the investigators will~     examine the gene-environment interaction of the top 14 targeted candidate genes and~     epi-genome wide effects of teens' stress biomarkers and its influence on blood glucose levels~     over time.~   "
45549|NCT02970643|"~     The purpose of this study is to determine whether Palonosetron and Olanzapine without~     dexamethasone for the Prevention of moderate risk Chemotherapy-Induced Nausea and vomiting.~   "
45520|NCT02971033|"~     To address the need for more affordable hepatitis C virus (HCV) antivirals with high barriers~     to viral resistance and strategies to shorten the current treatment duration, the goal is to~     develop affordable therapeutic regimens to prevent HCV entry/spread and test the efficacy of~     those inhibitors for treating HCV infection. The investigators recently discovered that a~     major cholesterol uptake receptor is required for HCV entry into hepatocytes and that there~     is already an FDA-approved drug that inhibits cholesterol uptake by this receptor.~     Importantly the same drug also potently blocks HCV entry in human liver cells both in cell~     culture and in a small animal model. Further, looking back at people who were previously~     treated for HCV infection, the investigators found treatment response to be better (i.e.~     larger viral log reduction) in patients who happened to be taking ezetimibe (EZE). Hence, the~     objective of this study is to assess whether the FDA-approved drug (ezetimibe) is useful for~     the treatment of chronic HCV. The investigators predict that when administered as monotherapy~     ezetimibe will reduce HCV viremia perhaps allowing for viral clearance and that when included~     in combination treatment regimens that EZE will increase HCV decline resulting in faster~     viral clearance (i.e. shorter/cheaper direct-acting antiviral [DAA] therapy). To test these~     hypotheses, the investigators will execute the following aims: (1) Assess the efficacy of EZE~     monotherapy in chronically HCV infected and predict time to cure; (2) Assess the efficacy of~     EZE as an adjunct therapy in chronically HCV infected patients undergoing currently approved~     HCV DAA treatment.~   "
45521|NCT02971020|"~     The investigators are conducting a pilot study to compare cognitive outcomes among Veterans~     with severe aortic valve stenosis who are scheduled to undergo either aortic valve~     replacement.~   "
45522|NCT02971007|"~     This is a multi-center, randomized study to evaluate the safety, tolerability, and efficacy~     of 200 mg CAMB and 400 mg CAMB compared with a single 150 mg dose of fluconazole in the~     treatment of moderate to severe VVC.~   "
45523|NCT02970994|"~     This study will evaluate the association of linear growth on neurobehavioural outcome in~     preterm neonates at 37 and 40 weeks of (CGA) corrected gestational age.~   "
45524|NCT02970981|"~     The purpose of this study is to assess the safety and tolerability of treatment with~     Nivolumab in combination with Ipilimumab in subjects with resected Stages IIIB/IIIC/ IV~     melanoma.~   "
45525|NCT02970968|"~     This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in~     the United States. One hundred fifty (150) subjects diagnosed with gastroparesis, who satisfy~     the selection criteria for the study, will be randomized to one of two treatment groups,~     active or placebo.~   "
45526|NCT02970955|"~     Oligometastatic patients with inoperable thoracic nodes metastases from any primary, except~     for hematologic malignancies, will undergo a risk adaptive scheme of stereotactic body~     radiation therapy (SBRT).~   "
45527|NCT02970942|"~     Investigation of efficacy and safety of three dose levels of subcutaneous semaglutide once~     daily versus placebo in subjects with non-alcoholic steatohepatitis~   "
45528|NCT02970929|"~     An extension study of safety and tolerability of SEP-363856 in adult subjects with~     schizophrenia~   "
45529|NCT02970916|"~     The purpose of this study is to assess FOLFIRI+aflibercept efficacy in patients with or~     without ACE polymorphisms in terms of Progression-free survival (PFS).~   "
45530|NCT02970903|"~     The VitalPAD is a unified, portable and intelligent device that integrates information from~     multiple patient monitors, mechanical ventilators, infusion pumps and clinical information~     systems on a mobile platform. It will allow nurses, respiratory therapists and physicians to~     continuously monitor and coordinate care of critically ill patients.~      This study will use a participatory design process to guide the design of an integrated~     mobile device, followed by an evaluation of the proposed device in a simulated ICU setting.~   "
45531|NCT02970890|"~     Osteoarthritis (OA), a chronic degenerative muscle disease characterized by cartilage wear,~     causes progressive joint deformity and loss of function leading to the indication of total~     hip arthroplasty (THA), when conservative treatments fail. Surgical trauma leads to pain and~     induces an immune response. Photobiomodulation therapy (PBMT) has proven effective in tissue~     repair by modulating the inflammatory process and promoting pain relief. It can therefore be~     part of the treatment. This study aims to analyze the effect of PMBT on inflammation and pain~     of patients who underwent total hip arthroplasty. The study consisted of eighteen patients~     who underwent hip arthroplasty and they received phototherapy in a period from 8 to 12 hours~     after surgery. We divided the patients into two groups (n=9 each) placebo and effective~     phototherapy. The patients were evaluated before and after phototherapy with 9 diodes,~     applied to 5 points along the scar (1 laser 905nm, 4 LEDs 875nm and 4 LEDs 640nm, 40.3J~     total), by visual analogue scale (VAS) and blood collection for analysis of the levels of the~     cytokines TNF-α, IL-6 and IL-8.~   "
45532|NCT02970877|"~     More and more people in Canada and around the world are severely (morbidly) obese, and this~     is associated with a high risk for poor blood sugar control (insulin resistance, IR) and~     diabetes. Weight loss is often very hard to achieve for morbidly obese patients. Bariatric~     surgery is a very effective treatment, but it has some risks and is not available to all~     patients. Therefore, alternative treatments are needed.~      The gut bacteria (intestinal microbiome) might play a role for the development of obesity and~     IR. Several studies in animals have shown that transferring stool from lean mice or humans~     into obese animals could lead to weight loss and improve IR. One human study has confirmed~     this. The investigators are therefore examining, whether transfer of stool from healthy lean~     people into morbidly obese patients with IR will improve blood sugar control, weight, and~     other obesity related parameters. This will be done in a randomized controlled trial. Effects~     on mental health and the bacterial in the mouth related to gum disease will also be assessed.~      If successful, fecal transfer could be a new alternative treatment approach for morbidly~     obese patients or those with IR who do not have access to or do not want to undergo bariatric~     surgery.~   "
45533|NCT02970864|"~     Participants with a traumatic sensory nerve injury in the hand will be recruited to the~     study. Participants found to have a nerve gap of at least 5 mm and no greater than 20mm will~     undergo repair with the Polynerve. Participants will be followed up regularly, observed for~     device-related complications and to assess the return of sensory innervation.~   "
46000|NCT02964754|"~     To verify whether digital three-dimensional model-assisted internal fixation can obtain~     better effects in the repair of complex long bone fractures compared with conventional~     internal fixation.~   "
45539|NCT02970773|"~     The primary objective of this study is to investigate the pharmacokinetic and -dynamic~     properties of rivaroxaban after oral administration in cervical spinal cord injury (SCI)~     individuals.~      The secondary objective of this study is to determine the steady-state rivaroxaban activity~     in cervical SCI individuals under long-term therapy.~      Primary Objective In-house patients will be informed concerning the study and informed~     consent will be collected.~      During the screening day, in- / exclusion criteria will be assessed and a blood samples will~     be taken for assessing haematology, clinical chemistry and coagulation parameters.~     Furthermore, the evaluation day will be scheduled.~      On the evaluation day, in- / exclusion criteria will be re-assessed. A venous catheter will~     be introduced into a forearm or lower leg of each participant for the collection of blood at~     the specified time points. Skin inspection for subcutaneous bleeding will be performed and~     vital signs will be recorded. A blood sample will be taken for assessing haematology,~     clinical chemistry and coagulation parameters.~      Single administration of oral rivaroxaban in the form of Xarelto® 10mg tablets (Bayer~     Schering Pharma, Berlin, Germany).~      Rivaroxaban concentrations will be determined from plasma samples taken before, 30min after~     and 1, 2, 3, 4, 5, 6, 8, 12, 24 hours after rivaroxaban administration. Rivaroxaban activity~     will be determined from plasma samples taken before, 30min after and 1, 2, 3, 4, 5, 6, 8, 12,~     24 hours after rivaroxaban administration using a factor Xa inhibition test and measuring~     prothrombin time (PT) and activated partial thromboplastin time (aPTT).~      Skin inspection for subcutaneous bleeding and measurements of vital signs will be performed~     30min and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours after rivaroxaban administration.~      Secondary Objective Patients under long-term rivaroxaban therapy will be recruited during~     their annual check-up visit at the Swiss Paraplegic Centre. In- / exclusion criteria will be~     assessed, and the patients will be informed concerning the study and informed consent will be~     collected.~      Blood samples will be taken for assessing haematology, clinical chemistry and coagulation~     parameters, and skin inspection for subcutaneous bleeding and measurements of vital signs~     will be performed.~      A blood sample (4.3ml citrated venous blood) will be taken for assessing the primary and~     secondary outcome parameters.~   "
45540|NCT02970760|"~     Adenomas are polyps of the colorectum that have the potential to develop into colon cancer.~     However, some adenomas never become malignant tumors, or if so, progression from adenoma into~     cancer takes a long time. As a result, screening colonoscopy programs were established in~     order to detect and resect adenomas at an early stage. After resection, polyps should be sent~     to pathology in order to make a histological diagnosis. Approximately 40-50% of all polyps~     have adenomatous histology whereas others contain benign histology (e.g. hyperplastic or~     inflammatory polyps). The latter polyps do not bear the risk to develop colon cancer.~      The bigger a polyp is the greater the chance is of it being malignant. During colonoscopy~     polyp size can be estimated visually by comparing the polyp with an opened biopsy forceps.~     The span of an opened forceps is 7 mm. Prior to using this technique, the forceps has to be~     inserted into the colon through a small working channel of the endoscope. Information on the~     actual adenoma size is crucial as surveillance recommendations depend on the size of the~     resected polyps. Moreover current guidelines contain the possibilities to disregard~     hyperplastic polyps in the sigmoid colon if the polyp size is below 5 mm. This means that~     diminutive hyperplastic polyps (< 5mm) do not necessarily require resection due to their~     benign dignity. However, there is increasing evidence that large human bias effects exist in~     estimating the size of polypoid lesions. For example, it has been shown that endoscopists~     exhibit terminal digit preferences leading to an exaggeration of estimated polyp size. In~     consequence the human bias problem might lead to wrong adenoma surveillance decisions.~      There is no doubt that technical devices are needed which can support endoscopists in finding~     the right declaration of polyp sizes. The aim of the current project is to create a computer~     program that is able to automatically measure polyp sizes during colonoscopy.~   "
45541|NCT02970747|"~     The objective of this non-interventional study (NIS) is to evaluate patients' adherence and~     persistence to carfilzomib therapy in combination with lenalidomide and dexamethasone or~     dexamethasone alone in adult patients with multiple myeloma (MM) who have received at least~     one prior therapy in a real-life setting.~   "
45542|NCT02970734|"~     Anxiety is a common mental health problem for Canadian adolescents. Anxiety that is diagnosed~     as a disorder and serious enough to require treatment affects up to 10% of all adolescents by~     the age of 16. The median age of onset is 11 years, making these disorders some of the~     earliest to develop. Anxiety disorders can have serious negative effects on a young person's~     personal relationships, school performance, and family life. These disorders may not be~     discovered by adolescents, parents and health care providers. Even if anxiety disorders are~     discovered, adolescents may not get the right therapy. Anxious adolescents can become sick if~     their anxiety is not treated properly. The investigators will carry out research to test~     Breathe, an Internet-based treatment for adolescents with anxiety problems. Adolescents can~     use this treatment from home via the computer. Breathe will include information materials and~     personalized homework assignments to help anxious adolescents learn ways to manage anxiety.~     More information can be found and www.TheBreatheStudy.com~   "
45543|NCT02970721|"~     The objectives of the proposed project are:~        1. To describe the patterns of mood stabilizer, antipsychotic, antidepressant, and~          anxiolytic prescriptions during pregnancy over a period of 12 years (2002-2014) in women~          aged 13 to 50 years who are diagnosed with bipolar disorder in Ontario.~        2. To identify the factors associated with use of antipsychotics, antidepressants, and~          antipsychotic-antidepressant polytherapy in pregnant women diagnosed with bipolar~          disorder.~        3. To assess the impact of antipsychotics, antidepressants, and~          antipsychotic-antidepressant polytherapy on the risk of maternal, neonatal, and labour~          and delivery outcomes in women with bipolar disorder.~        4. To assess the impact of antipsychotics, antidepressants, antipsychotic-antidepressant~          polytherapy on psychiatric readmission rates during the early postpartum period in women~          with bipolar disorder.~   "
45544|NCT02970708|"~     To evaluate the efficacy and safety of Eyetronix Flicker Glassess therapy in treating~     anisometropic amblyopia.~   "
45545|NCT02970695|"~     Objective To determine the optimum treatment protocol of auriculotherapy (AT) on the~     improvement of sleep conditions and quality of life on the elders with insomnia.~      Research hypothesis The use of combined LAT plus MAT is more effective than MAT/LAT alone on~     the improvement of sleep conditions and quality of life in the elderly with insomnia.~      Design and subjects This is a 3-arm double-blinded randomised trial. Subjects aged ≥65 and~     exhibit poor sleep conditions are recruited.~      Interventions Group 1: Subjects will receive a deactivated laser treatment followed by MAT.~     Group 2: Subjects will receive LAT and placebo MAT. Group 3: Subjects will receive a combined~     approach (LAT plus MAT).~      The treatment will be delivered 3 times/week, with a 6-week treatment period, on seven~     specific auricular points.~      Main outcome measures Sleep conditions and quality of life will be evaluated at baseline; end~     of 6-week treatment; and at 6-week, 12-week, and 6-month follow-up periods.~      Data analysis Descriptive statistics, chi-square analysis, ANOVA, paired t-test, and mixed~     effect modeling will be conducted as appropriate.~      Expected results This study would advance our knowledge the optimum treatment protocol of AT~     in the improvement of the sleep conditions of the elderly population.~   "
45546|NCT02970682|"~     This is a Phase 2 study to demonstrate the safety and efficacy of SFX-01 when used in~     combination with aromatase inhibitors (AIs), tamoxifen and fulvestrant.~      Patients will be enrolled into one of three study arms (SFX-01 in combination with AI,~     tamoxifen or fulvestrant) based on their current therapy.~   "
45547|NCT02970669|"~     The purpose of this study is to investigate the effects of initiation of sacubitril/valsartan~     vs enalapril treatment on objective measures of both waking activity and sleep in subjects~     with heart failure with reduced ejection fraction.~   "
47083|NCT02950610|"~     The purpose of this is to analyse human exhaled breath by means of a device called electronic~     nose(eNose) in patients with non-alcoholic fatty liver disease (NAFLD) as a way to~     non-invasive assessment of liver disease.This device is medically adapted and clinically~     validated in patients with lung conditions.~   "
45552|NCT02970604|"~     Heart attacks and strokes are common causes of death worldwide. These events occur in part,~     due to increased activity of platelets, which cause clotting (thrombosis) within heart and~     brain blood vessels.~      Anti-platelet therapies (e.g. aspirin) reduce the likelihood of platelet thrombosis and~     therefore protect against heart attacks and strokes. However serious bleeding into the gut~     and brain occurs in a number of individuals prescribed aspirin. Currently, there is no~     reliable method for assessing the relative risks of thrombosis versus bleeding in individual~     patients prior to or during aspirin therapy.~      We have recently discovered that individuals with a particular genetic make-up, those with~     genetic variants in two genes called PPARGC1β and CNTN4, demonstrate more active (sticky)~     platelets. We then found that these same individuals suffered a greater number of~     cardiovascular events. Interestingly, low dose aspirin suppressed the excessive platelet~     stickiness and protected against heart attacks and strokes in these patients.~      In this project, we aim to confirm and extend the above findings. We hope that testing for~     PPARGC1β and CNTN4 genetic variants will allow us to identify which patients will benefit~     from low dose aspirin therapy - i.e. receive protection from heart attacks and strokes, but~     not suffer any bleeding complications.~   "
45553|NCT02970591|"~     Irritable Bowel Syndrome is a common disease to which there is no curable treatment. Diet is~     considered to trigger symptoms associated with the clinical picture of IBS, and dietary~     treatment is thus believed to relieve the symptoms of IBS. As the disease is very~     heterogeneous in its manifestation, different treatment options might be indicated depending~     on the predominant symptom. To investigate the response to different dietary treatment~     options, a randomized controlled intervention trial will be carried out in adult patients~     (>18 y) with IBS according to Rome III criteria. The aim of this study is to compare the~     response to two different dietary treatments or optimized medical treatment.~   "
45554|NCT02970578|"~     To explore the accuracy of 3D printed module assisted minimally invasive lumbar pedicle screw~     placement using Quandrant system, and verify its feasibility of reducing error rate of screw~     placement and postoperative complications.~   "
45555|NCT02970565|"~     The purpose of this current study is to investigate the efficacy of a group model of Family~     Nurture Intervention in ameliorating behavioral problems in preschool-aged children. The~     behavioral, neurobiological and clinical insights gained from this project may eventually~     lead to better treatment of emotional, behavioral and developmental disorders. The~     investigator hypothesizes that the children who are treated with Family Nurture Intervention~     (FNI), which incorporates interactive touch with vocal soothing, and family practice in~     comforting, will show increased emotional connection and mother child co-regulation with~     better results in the outcome measures in the short term and long term.~   "
45556|NCT02970552|"~     More than 1.5 million HIV-infected women become pregnant each year. Approximately half have~     access to antiretroviral therapy (ART), but all are at increased risk of preterm birth (PTB).~     Vaginal progesterone (VP) is a promising and cost-effective intervention to prevent PTB that~     should be studied in this high-risk population. This pilot study will provide critical~     insight into the feasibility of a phase III trial by determining whether women are willing to~     participate, to adhere to study drug, and to complete follow-up.~   "
45557|NCT02970539|"~     This is a nonrandomized, open-label, single group assignment, safety, tolerability and~     pharmacokinetic (PK) study to determine the MTD and optimal dosing regimen of Oraxol in~     combination with ramucirumab.~   "
45558|NCT02970526|"~     This project will evaluate the neurotoxic effects of oxaliplatin. Oxaliplatin is considered~     the most neurotoxic chemotherapy, and at the origin of peripheral neuropathies. These~     neuropathies remain a problem in oncology because currently no prevention strategy has proved~     effective and only duloxetine seems to have a therapeutic benefit in improving symptoms. In~     the case of oxaliplatin, neuropathy forced oncologists to reduce the dose or to stop the~     chemotherapy, potentially degrading the oncological prognosis.~      Objective of this study will be to assess, on a large number of patients (n> 500) who~     completed adjuvant chemotherapy (FOLFOX), the intensity of neuropathic disorders out of 5~     years after the end of chemotherapy. Furthermore, this study should enable an assessment of~     the relationship between the intensity of neuropathy and comorbidities, such as anxiety and~     depression and health related quality of life of patients.~   "
45559|NCT02970513|"~     The purpose of this study is to determine whether the presence of pathogenic Escherichia coli~     in colon is associated with psychiatric disorders.~   "
45560|NCT02970500|"~     Cancer-related cognitive Impairment, (CRCI) commonly referred to as chemo brain or brain~     fog—impact severely on the Quality of Life (QoL) of cancer survivors, It still remains~     underdiagnosed and challenging to treat. One of the treatment options is the use of~     psychostimulants such as Methylphenidate (MP), but well-designed clinical trials to test its~     efficacy are limited. We will conduct a phase II study with a mixed method design to explore~     the preliminary efficacy of MP to improve cognitive function and Quality of life in breast~     cancer patients after treatment with chemotherapy and/or radiotherapy and determine the~     parameters needed for designing a phase III study. This study will include two phases: Phase~     one: randomized placebo-controlled clinical trial, phase 2 open-label trial.~   "
45561|NCT02970487|"~     The purpose of this study is to determine the refractive outcomes and optimize the clinical~     features of a new intraocular lens intended to treat the senile cataract.~   "
45562|NCT02970474|"~     Some radiation therapy treatment plans require the use of boluses. Boluses are placed~     directly on the skin overlying the area to be treated. The radiation beam interacts with the~     bolus before entering the body and ensures that the correct radiation dose reaches your~     tumor. The purpose of this study is to determine whether the shortcomings of conventional~     bolus preparation can be overcome by using a 3D printer. CT scans of the body can be used to~     create 3D models for boluses. The 3D models can then be printed into plastic boluses using a~     3D printer. Preliminary studies have shown that 3D printed boluses conform to body contours~     better and allow for more precise control over radiation dose. In this study, both a~     conventional and 3D printed bolus will be made. The Investigators will then simulate~     treatment with both boluses to determine which bolus will result in more optimal treatment~     for the participant. The superior bolus will be used in the participant's treatment.~   "
45563|NCT02970461|"~     A randomized controlled trial design is used to test the efficacy of gamification elements to~     drive user behavior in a personal health record.~   "
45564|NCT02970448|"~     The investigators of this study want to see if shortening the total treatment time for brain~     tumors is safe.The treatment for participant's brain tumors is laser surgery (Laser~     Interstitial Thermal Therapy (LITT)) followed by radiation with chemotherapy. For~     participants, the total time of treatment from surgery to the end of radiation and~     chemotherapy is about l 0 weeks long. This study asks whether it is safe to shorten the total~     treatment to 7 weeks.~      To shorten the total treatment time, investigators want to see if it is safe to start~     radiation with chemotherapy within 5 days after surgery. Usually patients start their~     radiation with chemotherapy about 21-28 days after the surgery.~      Shortening the total time of treatment may allow investigators to kill the cancer cells more~     effectively.~   "
45565|NCT02970435|"~     The purpose of this research is to look at how educational videos provided by doctors might~     affect patients knowledge, satisfaction, confidence, and anxiety with post-operative Mohs~     surgery care. Patients will be randomized to either: 1) a group that receives educational~     videos in addition to standard-of-care written and verbal instructions or 2) a group that~     receives only standard-of-care written and verbal instructions.~   "
45566|NCT02970422|"~     The purpose of this study is to distribute a questionnaire created for individuals living~     with chronic obstructive pulmonary disease (COPD) to assess their activities, participation,~     and healthcare and COPD-related research priorities. The data collected will be compared~     across diagnosed COPD stages and disease severity to determine the extent to which adults~     with COPD participate in the listed activities and identify their primary research and~     healthcare related priorities. The questionnaire was originally developed based on past~     research then verified by a panel of COPD and participation experts; as well as, individuals~     living with COPD in the form of focus groups. The questionnaire will now be administered to~     200 individuals living COPD (50 in each GOLD stage) at three sites across Montreal where~     clinical data for each participant will be available. This phase will help establish the~     reliability of the questionnaire.~   "
45567|NCT02970409|"~     A clinical, prospective. controlled and randomized study with patients with a peripheral~     venous catheter. Patients will be randomized to either receive heparin or saline. The~     investigators will monitored the clinical out come to further evaluate catheter colonization~     rate, phlebitis rate, days of hospital stay, antimicrobial costs, and adverse effects.~   "
45568|NCT02970396|"~     This is an investigation of adult individuals with epilepsy, and involves educational and~     behavioral interventions intended to enhance treatment adherence and self-management.~      The investigators are adapting a self-management intervention that they developed in a~     previous study to individuals with epilepsy and a history of negative health events (NHEs),~     such as accidents and emergency department (ED) visits, diminished quality of life and poor~     mental well-being. The intervention Self-management for people with epilepsy and a history~     of negative health events (SMART) is intended to reduce NHEs and improve quality of life in~     people with epilepsy associated with historically disadvantaged groups.~   "
45569|NCT02970383|"~     This study evaluates the effect of larger or smaller opioid prescriptions following minor~     surgery on the amount of narcotic used, patient reported satisfaction, refill requests, and~     leftover narcotic.~   "
45570|NCT02970370|"~     The primary study aim is to depict the demographics, clinical and para clinical features of~     patients attending five tertiary referral multiple sclerosis (MS) centers in Egypt.~      This requires effective and unified pooled registries to extract data from with a~     standardized, sufficient and high quality clinical, magnetic resonance imaging (MRI) data,~     neurophysiological data and body fluids.~      Investigators want to shed light on the challenges that face both physicians and patients in~     the area of diagnosis and treatment~   "
45571|NCT02970357|"~     The needs of children and teens with type 1 diabetes are very specific and different from the~     adults with type 1 diabetes. Many organizations such as the World Health Organization or the~     International Society for Pediatric and Adolescent Diabetes, recommend a patient therapeutic~     education when it comes to children with type 1 diabetes.~      This study aims to evaluate the impact of a therapeutic education program on theoretical~     knowledge of the disease and also on quality of life, on biological and clinical indicators.~   "
45572|NCT02970344|"~     The proposed randomized clinical trial evaluates a diabetes coping skills training (DCST)~     intervention for improving breast cancer survivors' abilities to manage symptoms and adhere~     to recommended diabetes self-management. The telephone-based DCST protocol integrates three~     key strategies to reduce symptoms and improve diabetes self-management: coping skills~     training for managing symptoms, adherence skills training, and healthy lifestyle skills~     training. The investigator will test the effects of the DCST intervention by comparing it to~     diabetes education alone. Physical symptoms, psychological distress, diabetes self-management~     behaviors, and self-efficacy for managing symptoms and diabetes self-management will be~     assessed at baseline and 3, 6, and 12 months. Physical activity (i.e., daily steps and~     distance) will be assessed using wireless activity trackers (Fitbit) and data will be~     obtained from home blood glucose monitoring devices. Fasting insulin, fasting glucose, and~     glycosylated hemoglobin (HbA1c) will be assessed at baseline, 6, and 12 months.~   "
45573|NCT02970331|"~     A multi-center, open-label study that will evaluate the safety/tolerability and~     pharmacodynamics as well as the pharmacokinetic profile (sub-population analysis), in 50~     evaluable adolescents 12 to < 17 years of age.~   "
45574|NCT02970318|"~     This study is designed to evaluate the efficacy of acalabrutinib compared with rituximab in~     combination with idelalisib or bendamustine in previously treated subjects with chronic~     lymphocytic leukemia (CLL).~   "
45575|NCT02970305|"~     To evaluate the efficacy and safety of adjunctive pimavanserin compared with adjunctive~     placebo in the treatment of the negative symptoms of schizophrenia~   "
45576|NCT02970292|"~     To evaluate the efficacy and safety of adjunctive pimavanserin compared with adjunctive~     placebo in the treatment of schizophrenia~   "
45605|NCT02969915|"~     This clinical trial will compare the effectiveness of integrated care centers vs. integrated~     care centers plus HIV patient treatment incentives for achieving HIV treatment targets among~     people who inject drugs and men who have sex with men in India. The investigators will also~     assess cost-effectiveness and barriers and facilitators to implementation through targeted~     mixed-methods approaches. This study is a model for improving HIV treatment outcomes in key~     populations in low to middle-income countries.~   "
45577|NCT02970279|"~     Depression is one of the most common mental health disorders and it is estimated up to 50% of~     patients do not respond to evidenced-based psychotherapy treatment, recording a 'stasis'~     outcome. However, there is limited research understanding this population, meaning a~     considerable number of people continue to suffer. The purpose of this study is to 1) identify~     depression stasis prevalence and predictors in an existing evidenced-based group treatment~     for depression, 2) run a clinical trial to test whether an embedded intervention based on~     theoretical and clinical practice evidence can help reduce patient depression stasis and~     drop-out rates and 3) understand what aspect of therapy produces change (or prevents change~     in stasis). The study will be based on behavioural activation (BA) therapy delivered in an~     eight-session group format in an Improving Access to Psychological Therapies (IAPT) service~     in the United Kingdom. BA is one of the most effective psychotherapies available for~     depression and focuses on helping patients to increase their engagement with valued~     activities to help break out of the cycle of depression. Firstly, an archived anonymised~     dataset of routine depression measures from patients who have previously received the~     existing group BA treatment will be analysed. Secondly, the group BA treatment delivered to~     patients in 2017 will be enhanced with two treatment augmentations. One augmentation will~     target stasis outcomes through the addition of specific 'if-then' planning (known as~     implementation intentions) when setting between-session homework and the other augmentation~     will target patient drop-out by informing patients about group BA effectiveness and~     therapy-dose evidence. The stasis outcomes and drop-out rates from the enhanced treatment in~     the trial will be compared with the archived outcomes to see if the intervention has had an~     effect and the role of engaging in valued living as a mechanism of change for depression~     symptoms will be examined. It is hypothesised that a) 50% of patients who have received the~     existing BA group treatment for depression will have a stasis outcome, b) there will be a~     significant reduction in depression stasis outcomes and drop-out rate following the enhanced~     BA group treatment delivered in the trial and c) engagement in valued living will have a~     mediating effect on outcome for responding patients following the enhanced BA group treatment~     but the effect will not be present for patients with a stasis outcome.~   "
45578|NCT02970266|"~     The main objectives of this study are:~        1. Improve genetic counseling by establishment of prevalences of each of genetic subtypes~          within a expanded population of patients with LCA taking into account ethnicity of~          families.~        2. Confirm, refine or modify the genotype-phenotype correlations.~        3. Edit important recommendations for:~             -  The clinical and paraclinical exploration of a new patient based on genotype,~               especially for extraocular explorations, to book at certain genetic subtypes~             -  Prenatal care of a couple.~             -  Directing families to a therapeutic protocol in progress or in development.~        4. Individualize a panel of families without a mutation in the known genes and identify new~          genes responsible.~   "
45579|NCT02970253|"~     Direct Anterior Approach (DAA) for Total Hip Arthroplasty (THA): Capsular resection versus~     capsular flap retention.~      Prospective study design comparing clinical data in randomized THA patients who either had~     capsular resection or capsular flap retention.~   "
45580|NCT02970240|"~     Circumstantial evidence suggests that patients diagnosed with myalgic encephalopathy/chronic~     fatigue syndrome (ME/CFS) perform worse on day 2 in a 2-day consecutive cardiopulmonary~     exercise test (CPET). The aim of this study is to examine if CPET can distinguish between~     ME/CFS patients and healthy controls.~   "
45581|NCT02970227|"~     cohort of cardiomyopathy patients (suspected or validated inflammatory cardiomyopathy)~     recruited at baseline by the SFB-TR19 project. Standardized protocols used for the assessment~     of medical history and examinations, laboratory biomarkers, and the collection of various~     biosamples for biobanking purposes.~   "
45582|NCT02970214|"~     Follow-up of two hospital-based patient cohorts (heart failure, metabolic comorbidities in~     CVD), recruited at baseline by the GANI_MED-project (Greifswald Approach to Individualized~     Medicine). Standardized protocols will be used for the assessment of medical history,~     laboratory biomarkers, and the collection of various biosamples for bio-banking purposes.~     Comparisons with the general background population will be performed.~   "
45583|NCT02970201|"~     Dialysis treatment non-adherence is a prevalent problem among the end-stage renal population~     receiving chronic hemodialysis. The complications associated with missed or shortened~     dialysis sessions are serious and frequently require emergent medical care or~     hospitalization. Previous studies have shown that electronic messages have significantly~     improved attendance rates in a primary care setting, but these messages have not been~     validated in the chronic dialysis population.~      An electronic intervention has been developed by Epharmix, a WUSTL IDEA Labs~     (ideas.wustl.edu) team, which has the capacity to use automated SMS text messages and/or~     phone calls to notify patients prior to each upcoming appointment, as well as alert a~     designated patient advocate. Patients receiving the messages are provided with key contact~     information for a dialysis rescheduling phone line, transportation resources, social work~     services, etc. They may also receive instructions on what to do if they are experiencing~     physical symptoms and need educational facts about dialysis. In particular, the intervention~     is designed to demonstrate to patients that the center cares and is concerned for their~     health and wellbeing. This intervention may potentially improve patient adherence to their~     scheduled sessions, increase patient satisfaction with their treatment, and prevent medical~     complications associated with missed dialysis appointments.~      This study aims to determine whether an electronic intervention, which sends SMS text~     messages or phone calls of key dialysis treatment information, is able to improve dialysis~     treatment session attendance among dialysis patients with a history of poor attendance. We~     secondarily aim to identify the factors that may be barriers to dialysis treatment session~     attendance and the emergency department or hospital utilization associated with missed~     dialysis treatments.~      Patients will be prospectively identified, recruited, and randomized into two groups. Group A~     will receive the electronic intervention prior to their appointments; Group B will not~     receive any electronic intervention. After 8 weeks, crossover will occur for both groups and~     the study will continue for an additional 8 weeks. Participants' clinic records will be~     reviewed to determine the numbers of missed and attended appointments, as well as records of~     ED visits and hospital admissions. Subjects will be asked to complete a post-study~     satisfaction questionnaire.~   "
45584|NCT02970188|"~     The purpose of this study is to assess the safety and efficacy of time-restricted feeding~     (eating within an 8-hour window) for improving physiological function (vascular, motor,~     cognitive and metabolic function) in healthy middle-aged and older adults.~   "
45585|NCT02970175|"~     The diagnostic yield of flexible bronchoscopy for the diagnosis of lung cancer depends on the~     location and the histological type of the lesion, as well as on the number of biopsy samples~     performed. The increasing number of sampling is also important to provide material for~     molecular assessment of lung cancer. The French National Institute for Cancer recommends a~     number of 5 biopsies in order to reach a diagnostic yield of 88%. However, as increasing the~     number of bronchial biopsies comes with a higher risk of bleeding, the management of~     endobronchial bleeding may be determinant for the diagnostic yield.~      The most recent recommendations of the British Thoracic Society for the management of~     bronchial bleeding, after bronchial or transbronchial biopsy, are to inject 5 to 10 mL of~     1/10000 diluted adrenalin, or cold saline serum (04°C.). The French guidelines also include~     the use of endobronchial terlipressin, which has local vasoconstriction effect. After~     endobronchial administration of terlipressin, plasmatic concentrations are low, and are not~     clinically relevant.~      The hypothesis of this clinical trial is that endobronchial instillation of terlipressin~     before sampling endobronchial tumor will limit the endobronchial bleeding and allow to~     increase the number of biopsies performed and, eventually, the diagnostic yield.~   "
45586|NCT02970162|"~     This study evaluates the effect of withdrawing amifampridine phosphate treatment from~     patients with LEMS. One half of the patients will continue to receive amifampridine phosphate~     and the other half will receive placebo, during this double-blind study.~   "
45587|NCT02970149|"~     Background: Inflammatory bowel disease (IBD) is a group of disorders characterized by chronic~     inflammation of the gastrointestinal tract with remissions and relapses. The two most common~     subtypes are Crohn's disease (CD) and ulcerative colitis (UC). In 2012, the burden-of-illness~     report from the Crohn's and Colitis Canada estimated that the direct medical costs of IBD in~     Canada were over one billion dollars, primarily funded through the Canadian public healthcare~     system.~      Many life style-related factors may play an important role in the pathogenesis of IBD and can~     contribute to trigger disease relapse, but several of these factors are poorly understood.~     These factors may include sleep disturbances. Data on sleep disturbance in children with IBD~     are limited. Sleep deprivation has been shown to cause reactivation of colitis in animal~     studies but similar data are lacking in humans especially in children.~      Hypothesis: In children with IBD, high scores for a sleep disturbance screener will be~     positively associated with IBD relapse Objective: To develop a non-invasive non-costly tool~     to screen for relapses in pediatric IBD patients through examining the association between~     sleep disturbances and disease relapse in children with IBD Methods: This study will~     incorporate an observational prospective design. Participants: Participants will be 90~     children (ages 8-17 years ) under the care of the Pediatric IBD Program at the Children's~     Hospital, Winnipeg. All participants will have an established diagnosis of IBD.~      Measures: Sleep disturbances will be assessed using a sleep diary. Patients will be asked~     complete a daily sleep diary in the week preceding their clinic appointment. The sleep diary~     will provide information about latency to fall asleep, number of awakenings, duration of~     awakenings, total sleep time, sleep quality, and sleep efficiency.~      Mucosal inflammation will be assessed by measuring fecal calprotectin and clinical disease~     activity will be measured Pediatric Crohn's disease activity index (PCDAI) for CD and~     pediatric ulcerative colitis activity index (PUCAI) for UC at clinic visits~     Anxiety/Depression: As anxiety and depression are often comorbid with disturbed sleep, levels~     of symptoms in both domains will be assessed at clinic visit using the Child and Parent~     Report Versions of the Spence Anxiety Scale and the Child Depression Inventory (v. 2).~      Procedure: Upon obtaining informed consent, each participant will complete 7 days of sleep~     diary recording in the week prior to their clinic appointment. During the clinic visit, the~     PCDAI or PUCAI, Spence Anxiety Scales, Child Depression Inventory will be completed. Fecal~     samples will be collected for fecal calprotectin measurement as a surrogate marker for~     mucosal inflammation. Other investigations will include blood samples for serum hemoglobin,~     serum albumin, and inflammatory markers. Stool samples for infection screen will also be~     collected to exclude any possibility for gastrointestinal infection on top of IBD.A second~     clinic visit will be scheduled 3 months later and the whole process will be repeated in the~     second visit.~      Regression analysis will be performed to examine the association between sleep disturbances~     and disease activity, characteristics and patients' demographics~      Outcomes:~      Primary outcome: Cut-off score of a sleep screener that is associated with disease relapse~     (as diagnosed by fecal calprotectin value of >100 microgram/gram of stools) in children with~     IBD Secondary outcomes: 1. Correlation between sleep disturbance scores and clinical disease~     activity indices (PCDAI and PUCAI). 2. Identification of which sleep component (sleep~     duration, latency, fatigue, subjective quality) is the best at detecting a disease relapse.~      3.Identification of whether sleep disturbance more accurately predicts relapse for CD than~     for UC.~   "
45588|NCT02970136|"~     The purpose of this research study is to determine the best way to increase screening for~     cervical cancer, colorectal cancer, HIV, and Hepatitis C among underscreened Hispanic,~     Haitian and African-American individuals in Hialeah, South Dade, and Little Haiti. The~     investigator will compare home testing led by a community health worker (CHW) versus clinic~     testing guided by a CHW. Community Health Workers are people who have undergone several weeks~     of community outreach and health education training. During the study period the participant~     will continue to receive all of their regular medical care from their regular health care~     providers. If the participant does not have a health care provider, the Community Health~     Workers would be able to help in referring the participant for care at a local health care~     clinic located in their community.~   "
45589|NCT02970123|"~     Sedentary behavior is engaging in activities in the seated or lying position that barely~     raise the energy expenditure level and has emerged as an important risk factor for obesity,~     diabetes, cardiovascular disease and mortality.~      The primary hypothesis is that the Sit Less, Interact, Move More (SLIMM) intervention in~     Chronic Kidney Disease (CKD) will be effective in decreasing sedentary duration by increasing~     casual walking duration and thereby, increase physical activity energy expenditure.~   "
45590|NCT02970110|"~     The objective of this study is to acquire human specimens from subjects undergoing routine~     endoscopy with gastric biopsy for the diagnosis of active H. pylori infection.~   "
45591|NCT02970097|"~     The purpose of this study is to compare infraclavicular brachial plexus shot single shot~     block to local infiltration done in adult patients having wrist arthroscopy surgery. Visual~     analogue scores, opioid consumption, quality of recovery and quality of sleep up to 72 hours~     post operatively will be used for comparison.~   "
45592|NCT02970084|"~     Clinical study single center, prospective, randomized, controlled (vs. no supplement),~     open-label, blinded assessor (the doctor who will perform the Doppler ultrasound at 6 and 12~     months will not know the treatment given to the patient, because the diagnostic test in~     question is considered operator-dependent), a parallel group, which aims is evaluate the~     reduction in the level of calcium in the carotid artery and the carotid atherosclerotic~     plaques, on a sample of 60 subjects presenting subcritical calcified lesions of the carotid~     bifurcation with a range of 40-60%.~   "
45593|NCT02970071|"~     The objective of this study is to use of STIC technology to assist the traditional~     echocardiography to dignose the fetal congenital heart disease accurately and then to provide~     a basis for prenatal counseling.~   "
45594|NCT02970058|"~     Platelet-rich Plasma Use as Prophylactic of Post-operative Low Back Pain Following~     gynecological surgery.~   "
45595|NCT02970045|"~     This research trial collects biological samples and clinical information to create a~     repository of data from patients with cancer or a predisposition for cancer. Combining~     genetic information from biological samples and clinical data may lead to more knowledge~     about why certain cancers respond to treatment and help create more personalized medicine.~   "
45596|NCT02970032|"~     The purpose of this study is to determine if fixed dose heparin infusions at a rate of 500~     units/hour are sufficient to maintain a target anti-Xa of 0.1-0.35 IU/mL for VTE prophylaxis~     in patients undergoing microvascular surgery. Additionally, a pilot protocol has been~     developed to titrate these heparin infusions to ensure patients have sufficient VTE~     prophylaxis. All patients will be enrolled in the observational arm of the study and receive~     anti-Xa level monitoring. Patients with out-of-range anti-Xa levels will cross over to the~     interventional arm of the study and receive real time heparin infusion dose adjustments per~     the pilot protocol. The primary outcome measured will be the percentage of patients with~     anti-Xa levels in the target range of 0.1-0.35 IU/mL while on a heparin infusion at 500~     units/hour.~   "
45597|NCT02970019|"~     This is a safety, tolerability and pharmacokinetic study in subjects with Parkinson's disease~   "
45598|NCT02970006|"~     The study hypothesis is that spinal cord stimulation (SCS) combined with virtual leg~     illumination (provided through a wearable headset (OculusRift, OculusVR, Irvine, CA) and a~     custom-designed virtual reality leg scenario) will lead to controlled analgesia induction,~     boosting analgesic effects obtained with standard SCS treatments and will further be~     associated with changes in the perception of the affected body part.~   "
45599|NCT02969993|"~     Long term assesment of voice outcome after Montgomery Thyroplastie by performing a Survey of~     operated patients using the voice handicap index scale~   "
45600|NCT02969980|"~     This study is conducted to evaluate the feasibility and efficacy of post-transplantation~     cyclophosphamide with myeloablative or reduced-intensity conditioning regimen for allogeneic~     hematopoietic cell transplantation (HCT) in patients with myelodysplastic syndrome (MDS).~   "
45601|NCT02969967|"~     The purpose of this study is to explore the effectiveness of the SaeboFlex orthosis in~     improving upper extremity recovery for people in the early phases of rehabilitation post~     stroke. The objectives of the study are:~        1. to explore the effectiveness of the SaeboFlex orthosis in improving upper extremity~          function, strength, movement, spasticity and self-perceived occupational performance, in~          addition to conventional therapy, with continued use immediately after discharge from~          inpatient stroke rehabilitation and while waiting for outpatient occupational therapy~          services~        2. to explore the relationship between the participants' level of self-efficacy and use of~          the SaeboFlex orthosis in the home environment~        3. to explore the participants' experience of use of the SaeboFlex orthosis in the home~          environment.~   "
45602|NCT02969954|"~     Racial and ethnic minorities with type II diabetes in the US are more likely to develop~     complications and die from the disease than the general population. The foreign-born subset~     of this population is less likely to adhere to diabetes care recommendations than US-born~     patients, thereby placing them at higher risk for complications. In our previous pilot~     project, eight stories were assessed through preliminary multi-site intervention for~     acceptability and efficacy in diabetes management among Latino and Somali patients with~     poorly controlled type II diabetes. The goal of this project is to evaluate a new format for~     delivery of a culturally tailored digital storytelling intervention by incorporating a~     facilitated group discussion following the videos, for management of type II diabetes in~     Latino communities.~   "
45603|NCT02969941|"~     To investigate the treatment effect of continuous transcranial magnetic stimulation on~     patients with Parkinson disease, and the underlying neural mechanism by functional MRI~   "
45606|NCT02969902|"~     Venipuncture is one of the most common iatrogenic painful and stressful procedures performed~     on children. Interventions aimed at reducing the distress related to this experience are~     widely and strongly recommended. Pain and anxiety management is even more essential because~     it may modify children's memory for procedural pain and the subsequent acceptance of later~     health care painful interventions. Distraction is the most studied psychological technique to~     relieve venipuncture related pain and distress, with a strong evidence supporting its~     efficacy in children and adolescents.~      In recent years several studies showed the effectiveness of a specific tool named Buzzy® (MMJ~     Labs, Atlanta GA, USA), in relieving pain and distress in children. Buzzy combines~     distraction and physical analgesia (vibration and cold) and it was positively tested during~     venipuncture, intravenous cannulation and painful injections in children. Even though its~     efficacy it's well established, most of the published trials did not compare Buzzy with other~     interventions, so that little data are available about its usefulness compared with other~     distractions techniques.~      Hand-held computers are reusable tools, which offer a technological-based active distraction.~     There is evidence supporting their used during painful procedures such as venipuncture and a~     recent published study showed that hand-held computer distraction was as effective as~     nurse-led passive distraction techniques in children.~      The aim of this study is to compare the effectiveness of Buzzy versus hand-held computer in~     pain relief during venipuncture.~   "
45607|NCT02969889|"~     bmı > 35 morbidly obese patients requiring endotracheal intubation enrolled in this trial.~     Divided into two groups Airtraq and ILMA. their effectiveness is evaluated.~   "
45608|NCT02969876|"~     The study is a 6-week, proof-of-concept, open trial of vortioxetine for 20 patients with~     major depressive disorder.~   "
45609|NCT02969863|"~     To conduct an outpatient study testing two configurations of the bionic pancreas (bi-hormonal~     and insulin-only) with and without remote monitoring of hypoglycemia in 25 adult (≥ 18 years~     of age) subjects with type 1 diabetes in a random-order crossover study versus usual care~     with an insulin pump with and without remote monitoring of hypoglycemia.~   "
45610|NCT02969850|"~     Although the African-American (AA) population tends to have lower serum 25(OH)D levels~     compared to whites, there is no evidence that the lower 25(OH)D levels in African-Americans~     are harmful. In fact, skeletal health is superior in AA. It is clear that total serum 25(OH)D~     concentrations do not reflect the same risk/benefit ratio in AA compared to white women and~     is, therefore, an inappropriate biomarker in this population.~      The investigators wish to investigate whether free 25(OD)D and Vitamin D Metabolite Ratio~     (VMR, ratio of 25(OH)D to 24,25(OH)2D) are preferable biomarkers to total 25(OH)D. The~     investigators propose a six month randomized double blinded study.~   "
45611|NCT02969837|"~     This study will be a multi-center, open-label, Phase 2 study where newly diagnosed Multiple~     Myeloma requiring systemic chemotherapy will be eligible for enrollment. A total of 55~     subjects will be enrolled. Time to progression or death will be calculated from the date of~     first treatment on protocol until the date of disease progression or death from any cause.~     Patients can expect to participate between 12-24 cycles. The primary endpoint will be the~     rate of response by next generation gene sequencing at the end of 8 cycles among~     non-transplant candidates and transplant candidates who agreed to defer transplant.~   "
45612|NCT02969824|"~     This study will investigate the effect of standardized aerobic exercise (AE) compared to rest~     on clinical recovery from sport-related concussion (SRC) within the post-acute phase of~     injury. Participants will be randomized into one of two groups: (1) Aerobic Exercise Group:~     participants will complete a total of eight exercise sessions over the course of 11 days,~     starting at Day 3 post-injury; (2) Usual Care Group: individuals will undergo a period of~     physical rest and standard care until symptoms spontaneously resolve. For the purposes of~     this study, rest will be defined as the avoidance of any activities beyond those of daily~     living, including participation in sport and physical activity.~   "
45613|NCT02969811|"~     Blood transfusion is an expensive and finite resource and optimum transfusion threshold in~     surgical patients is yet to be defined. Patients commonly receive blood transfusions to~     reduce the risk of myocardial ischaemia or improve perfusion of other organs (e.g. the~     kidneys), but this treatment may have important adverse effects including postoperative~     infection. Patients undergoing surgery for fractured neck of femur are often elderly, with~     co-morbidities and a high risk of postoperative complications, including MI and AKI. We~     propose to conduct a study with the following aims:~        1. To describe the incidence of anaemia and transfusion in patients undergoing surgery for~          fractured neck of femur.~        2. To use clinical and biochemical data to measure the incidence of perioperative cardiac~          and kidney injury in this group.~        3. To evaluate highly sensitive serum troponin and urinary MALDI-MS as possible endpoints~          in a future prospective randomised trial of perioperative transfusion.~   "
45614|NCT02969798|"~     HYPOTHESIS: Impaired glucose tolerance (IGT) and impaired fasting glucose (IFG) have distinct~     pathophysiologic etiologies. Therefore, therapeutic interventions designed to correct the~     specific underlying pathogenic abnormalities in IGT and IFG will be required to optimally~     prevent the progressive beta cell failure and development of overt type 2 diabetes.~   "
45615|NCT02969785|"~     The relevance of this study is given by the feasibility to assess the effect of an~     intervention program based on the postural control and trunk neuromuscular activity,~     comparing two methods: stabilization exercises vs. back strengthening exercises, in athletes~     with low back pain. The main outcomes will be computed by electromyography measurement so~     that to assess the trunk neuromuscular activation pattern as well as by force platform~     parameters for determining of postural control. Clinical symptoms such as pain intensity,~     perception of disability and fear and avoidance will also be computed. This is the first~     study to compare two intervention methods using the main biological outcomes related to trunk~     neuromuscular function.~   "
45626|NCT02969642|"~     This study evaluates the treatment of migraine pain using low energy laser light to quench~     migraine signals issuing from the sphenopalatine ganglion (SPG).~   "
45627|NCT02969629|"~     The study aimed to explore the effect of the dopamine agonist apomorphine on spontaneous pain~     intensity and evoked cold clinical and experimental pain in patients with lumbar radicular~     neuropathic pain (NP). Patients received either apomorphine or placebo in a randomized~     double-blinded manner.~   "
45616|NCT02969772|"~     The aim of the study was to evaluate the tetraplegics movement strategies, assisted by~     Neuromuscular Electrical Stimulation (NMES), on the reach and palmar (RP) grasp to different~     weights objects.Tetraplegics had their RP grasp movement captured by four infrared cameras~     and 6-reflexive markers attached on the trunk and right arm, assisted or not by NMES, in the~     triceps, extensor carpi radialis longus, extensor digitorum communis, flexor digitorum~     superficialis, opponens pollicis and lumbricalis muscles. The grasp was made in three~     cylindrical objects (different diameters and weights) placed in trunk midline in an~     equivalent distance of the arm's length. The patients were able to reach and made palmar~     grasp in all cylinders using the stimulation sequences assisted by NMES.~   "
45617|NCT02969759|"~     INTRODUCTION: Amyotrophic Lateral Sclerosis (ALS) is a degenerative disease of the motor~     neurones of the brain and the spinal cord. The pathophysiological mechanisms of the disease~     remain unknown. The average age of onset of ALS is about 60 years old, and the mean survival~     of patients is about 2 years. The disease is responsible for a progressive paralysis leading~     to death from respiratory failure. The only treatment available is the Riluzole, with a very~     modest efficiency on the progression of the disease. ALS is the third neurodegenerative~     disease, affecting 6000 persons in France, 150 000 in the world. Among the protagonists~     involved in the occurrence of the disease, mitochondrial perturbations and protein~     accumulations seem to be central elements.~      OBJECTIVES: To precise the implication of energy and protein metabolism in the sporadic forms~     of ALS, to identify potential biomarkers of the disease and to test new therapies.~      METHODS: The investigators will study cell growth, bioenergetics, mitochondrial dynamics,~     free-radicals production, presence of cytoplasmic inclusions, cytoskeleton structure and~     stress response in primary skin fibroblasts obtained from sporadic ALS patients. The study~     will be conducted over a period of three years in 3 centres specialized respectively in motor~     neuron diseases, mitochondrial metabolism and neuronal cytoskeleton.~      PROSPECTS: If the investigators achieve to identify differences between ALS fibroblasts and~     controls, the results will be key elements to reinforce the hypothesis of a systemic disease~     with an important metabolic participation, to better define ALS pathophysiological~     mechanisms, to find potential biomarkers and to test new therapies.~   "
45618|NCT02969746|"~     This is a prospective, multicentric, randomized, open labeled superiority trial~      This study aims to evaluate the efficacy of oral activated charcoal for improving elimination~     of direct oral anticoagulants ( Rivaroxaban, Apixaban) in case of an unscheduled invasive~     procedure delayed to this anticoagulant treatment.~      The primary outcome is the anticoagulant's half life. Plasma concentration will be measured~     by liquid chromatography-mass spectrometry for the main analysis (pharmacokinetic).~      A total of 140 patients will randomly be assigned to the charcoal or control group,~     stratified according to their anticoagulant drug.~   "
45619|NCT02969733|"~     Recent clinical studies in abdominal surgery have shown that the use of Xylocaine®~     parenterally intraoperative at plasma concentrations below the toxic threshold of 5 .mu.g /~     ml, had an analgesic effect and decreased postoperative morphine consumption.~      This study aims to evaluate the activity of Xylocaine® and ketamine separately administered~     parenterally, in terms of postoperative morphine consumption and decrease incidences of~     postoperative chronic pain at 3 and 6 months after laparoscopic colectomy compared the~     placebo group.~      The evaluation of the intensity of postoperative pain, hyperalgesia perished skin surface~     scarring) and pain perception threshold by Pain Matcher® confirm or not the predictive nature~     of these criteria in the occurrence of chronic pain.~   "
45620|NCT02969720|"~     The objective is to evaluate therapeutic efficacy of 2 grams nano-phytosterols daily~     supplemention on diagnosis criteria of metabolic syndrome.~   "
45621|NCT02969707|"~     The investigators plan to use functional neuroimaging (fMRI) to understand the brain systems~     affected when hypnosis and hypnotic analgesia are augmented with repetitive transcranial~     magnetic stimulation (rTMS), a form of non-invasive brain stimulation to 100 people with~     fibromyalgia, a chronic pain condition. The investigators will measure the effect of~     rTMS-augmentation on the brain networks underlying hypnotizability, as well as the effect of~     rTMS-augmentation on hypnotic analgesia networks. The investigators hope to demonstrate that~     a combination of these psychological and neuromodulatory treatments will be more effective~     than hypnosis alone, thereby enhancing the depth of hypnosis, range of hypnosis and the~     efficacy of hypnotic analgesia and hopefully creating a new treatment modality for~     individuals suffering from pain syndromes such as fibromyalgia pain.~   "
45622|NCT02969694|"~     Survey of fifty new psychoactive substances consumers in a context of MTM sexual intercourse.~      Evaluation using an hetero-assessment questionnaire about the link between hypersexual~     disorder and the use of synthetic cathinone.~      Evaluation on psychoactive drug addiction, the induced or pre-existing sexual practices and~     the medico-psycho-social consequences of those practices.~   "
45623|NCT02969681|"~     Preclinical study has shown that human colorectal cancer cells harboring KRAS or BRAF~     mutations are selectively killed by high levels of ascorbic acid (AA). High dose of AA aslo~     impairs tumor growth in Apc/KRASG12D mutant mice. Previous phase Ⅰ studies have found that~     high dose iv AA is well tolerated in cancer patients.This protocol is a phase Ⅲ study of AA~     infusions combined with treatment with FOLFOX/FOLFIRI +/- bevacizumab versus treatment with~     FOLFOX/FOLFIRI +/- bevacizumab alone as first-line therapy in patients with recurrent or~     advanced colorectal cancer.~   "
45624|NCT02969668|"~     The primary objective of study will be to evaluate the effectiveness of interferon-free~     direct acting antivirals (IFN-free DAAs) in the treatment of chronic hepatitis C virus (HCV)~     among patients in opioid-substitution treatment (OST). We hypothesize that rates of sustained~     virological response will be comparable to non-OST populations. Secondary objectives include~     the evaluation of safety data, patients` adherence and patient reported outcome measures like~     functioning (disability), satisfaction with the treatment, health status, general health~     perceptions and health-related quality of life.~   "
45625|NCT02969655|"~     Daprodustat is a drug that is currently being developed as a treatment for renal anemia .~     This study is to evaluate the efficacy and safety of daprodustat following a switch from~     erythropoiesis-stimulating agent (ESA) in Japanese HD subjects with renal anemia who are~     currently treated with ESA. The primary objective is to demonstrate non-inferiority of~     daprodustat to darbepoetin alfa. This study is a 52-week, Phase III, double-blind,~     active-controlled, parallel-group, multi-center study. The total duration of the study will~     be approximately 58 weeks including screening and follow-up.~   "
45630|NCT02969590|"~     The purpose of this study is to help us determine how hormones impact the production of~     cervical mucus which is a fluid secreted by the opening of the uterus, also called the~     cervix. During a normal menstrual cycle, cervical mucus changes in response to two hormones~     that the ovaries make: estrogen and progesterone. Many of the birth control methods women use~     thicken mucus and make it less likely for sperm to enter the uterus. The goal of this study~     is to better understand the effects estrogen and progesterone have on the cervical mucus in~     the body. To do this, the investigators will be using a drug that suppresses natural hormone~     production for 3 months. Estrogen and progesterone will be artificially replaced to better~     understand their effects. The investigators will also be studying the effect of a common~     birth control pill that may work by thickening cervical mucus. Last, the investigators will~     study some of the cells in the cervix that produce mucus.~   "
45631|NCT02969577|"~     The purpose of this study is to learn if lifestyle changes and counseling along with standard~     medical care, compared to standard medical care alone, can prevent heart problems and~     diabetes in men who are receiving ADT for prostate cancer treatment.~   "
45632|NCT02969564|"~     The number of metastases in a patient with primary or recurrent prostate cancer has major~     prognostic implication.~      The purpose is to compare, in a pilot study, the diagnostic performance of 18F-NaF-PET/MR~     with respect to the results of the scintigraphy 99mTc-MDP-SPECT/CT (routine exam) for~     determining the presence or absence of bone lesions in prostate cancer patient, with up to~     five metastases (oligo-bone metastatic) based on scintigraphy 99mTc-MDP-SPECT/CT. The gold~     standard will be a combination of clinical follow-up, additional imaging and biopsy, as~     indicated by the multidisciplinary discussion at the tumor board. The findings from~     whole-body 99mTc-MDP-SPECT/CT, 18F-NaF-PET/MR, and the combination of the 2 modalities will~     be categorized by 2 teams of 2 readers as benign or probably benign, equivocal, or malignant~     or probably malignant and compared with the results of follow-up for JAFROC and ROC analysis.~   "
45633|NCT02969551|"~     Patients with OSA receive manometry measurements with Apneagraph (AG) during one night of~     sleep. All patients are simultaneously evaluated with polysomnography. Patients who are not~     eligible for CPAP therapy are additionally studied with drug-induced sleep endoscopy (DISE).~     The frequency and obstructions patterns in different sleep stages are assessed. In addition~     obstruction patterns detected with AG are compared with DISE examination in the selected~     cases.~   "
45634|NCT02969538|"~     The aim of this study is to evaluate the effect of shortening the etching time on the~     18-month clinical performance of resin composite restorations in primary molars after partial~     carious removal. This randomized clinical trial will include subjects (5-10 year-old~     children) selected at Pediatric Clinic of Federal University of Santa Maria. The sample will~     consist of 70 primary molars presenting active cavitated carious lesions (with radiographic~     involvement of the outer half of the dentin), located on the occlusal surface. The sample~     will be randomly divided into two groups according to the etching time of the dentin prior~     adhesive application (Adper Single Bond 2; 3M ESPE): recommend by manufacturers (15 seconds)~     and half-reduced etching time (7 seconds). The restorations will be clinically followed every~     6 months for up to 18-month using the FDI criteria for clinical evaluation. Survival~     estimates for restoration longevity will be evaluated using the Kaplan-Meier method.~   "
45635|NCT02969525|"~     This is a study to evaluate the dose response based on the efficacy, safety and tolerability~     of bimekizumab in subjects with active psoriatic arthritis.~   "
45636|NCT02969512|"~     Osteoarthritis (OA), leading to hip replacement, is a leading contributor to global mobility~     impairment. Given the boom in the older demographic it is not surprising that there is an 11%~     increased demand for replacement every 5 years in Canada. Health promotion interventions,~     such as prehabilitation, defined as pre-surgical education, are vital to optimizing surgical~     outcomes, reducing hospitalization costs, accelerating rehabilitation, and reducing patient~     discomfort and pre-operative anxiety. HIPPER is a 2-year randomized controlled trial (RCT)~     that will assess feasibility indicators and clinical outcomes of online prehab education~     modules compared to a traditional in-person education. The feasibility indicators (process,~     resource, management, and treatment issues) and clinical outcomes (physical function,~     anxiety, pain, satisfaction with education, and health related quality of life) will be~     assessed among Vancouver-dwelling older adults aged > 50 years, with advanced hip~     osteoarthritis. The findings will lead to the refinement of the design protocol in order to~     evaluate a contemporary, standardized, and geographically accessible prehab education program~     in a large multi-site RCT.~   "
45637|NCT02969499|"~     This is a prospective, open-label, observational study of the efficacy and safety of ECT for~     BPSD. There is no control or comparison group. Subjects will be compared on outcome measures~     pre- and post-ECT (and/or with a repeated measures design). Target sample size is 30 subjects~     over three years~   "
45638|NCT02969486|"~     Pulmonary hypertension (PH) is a condition characterized by a sustained elevation in~     pulmonary artery pressure (PAP) above 25 mmHg assessed by right heart catheterization. PH is~     fatal in absence of adequate treatment or therapy, as the condition progressively increases~     the workload of the right heart and ultimately leads to its failure. With a minimal~     indicative prevalence of 1 case/300, PH affects at least 25'000 people in Switzerland alone.~     After initiation of PH therapy, the follow-up of the patient's health status is often limited~     to punctual PAP measurements at the clinic at intervals of several months. The lack of more~     frequent measurements of the patient's PAP strongly hinders the identification of short-term~     trends in pulmonary hemodynamics, and therefore the anticipation of worsening conditions or~     treatment inefficiency. As possible solutions, wireless implantable hemodynamic monitors such~     as the CardioMEMSTM HF System (CardioMEMS Inc., Atlanta, USA) have recently been introduced~     for the continuous monitoring of PAP in patients with PH. The benefits of frequent~     measurements over intermittent clinic visits have been demonstrated in several previous~     studies, notably in terms of prediction of therapy outcomes, anticipation of worsening heart~     failure, feedback rapidity during therapy, or decline in hospitalization rates. Nevertheless,~     despite the undeniable advantages that implantable monitors offer to the patient, they remain~     highly invasive solutions. In contrast, noninvasive alternatives for the measurement of PAP~     exist, such as transthoracic echocardiography, but are impractical for frequent PAP~     assessments due to their dependency on qualified personnel to perform the measurement. An~     optimal PAP monitoring modality for patients with PH should be non-invasive (free of any~     risks or complications associated with cardiac catheterization) and unsupervised (able to~     operate without supervision of a medical doctor). Such a modality does not currently exist.~     In the present study, the investigators propose and investigate the potential of a novel~     non-invasive, continuous and unsupervised PAP monitoring approach based on the pulse wave~     velocity (PWV) principle and the use of electrical impedance tomography (EIT).~   "
45639|NCT02969473|"~     In this phase II study, the investigators aim to evaluated the efficacy and toxicity of~     definitive concurrent chemoradiotherapy (CCRT) with docetaxel plus cisplatin (DP regimen)~     versus 5-fluorouracil plus cisplatin (PF regimen) in patients with esophageal squamous cell~     carcinoma (ESCC).~   "
45640|NCT02969460|"~     The Neurotrack Virtual Cognitive Health Study is a 6-month long, prospective,~     intent-to-treat, study that aims to evaluate the impact of the Neurotrack Virtual Cognitive~     Health Coaching Program on cognitive ability, anxiety and depression, and lifestyle behaviors~     for individuals who show signs of subjective cognitive decline. After the first 6 months of~     the study, the study researchers may extend the study and provide participants with the~     opportunity to continue participating in the study for an additional 6 months.~   "
45641|NCT02969447|"~     Prospective randomized trail which compare 2 regimens for third-stage management after second~     trimester medical pregnancy termination : 10UI intra venous oxytocin or no additional~     medication after fetal expulsion. Primary outcome was the incidence of placental retention.~   "
45642|NCT02969434|"~     Sleep impairments reliably predict worsened chronic pain and correlate with visual analogue~     pain scores. Therapies targeted at improving sleep, including cognitive behavioral therapy,~     improve both sleep quality and also pain management, and reduce interference of pain with~     daily activities. As effective pain relief decreases sleep disturbances, improvement in sleep~     has been proposed as marker of effective pain management. Hence it is useful to evaluate~     sleep disturbances in chronic pain population both in clinical and research setting. There~     are many tools to evaluate sleep quality; the routinely used simple brief pain inventory~     (BPI) has a single question about sleep. We will compare three dedicated sleep measures to~     the BPI in patients with chronic pain.~   "
45643|NCT02969421|"~     Randomized controlled trial that compares methods of tenaculum placement during intrauterine~     device insertion and their effect on pain. The two methods being compared are slow tenaculum~     placement versus tenaculum placement at time of cough. Subjects will be asked to rate their~     pain using visual analog scale. Primary outcome measured is pain at time of tenaculum~     placement. Secondary outcomes are overall pain with intrauterine device insertion and~     provider satisfaction with tenaculum placement.~   "
45644|NCT02969408|"~     This is a 12-week, multicenter, open-label study to evaluate the relationship between ABS~     eMDPI and clinical asthma exacerbation (CAE) in adult patients at least 18 years of age with~     exacerbation-prone asthma. The ABS eMDPI dose will be 90 mcg, 1 to 2 inhalations every 4~     hours as needed, but patient dosing will not be limited to this dosing regimen. The purpose~     of this study is to evaluate the relationship between albuterol dosing and CAE.~   "
45645|NCT02969395|"~     The purpose of this study is to evaluate product performance of Magnetic Resonance (MR)~     Conditional Cardiac Implantable Electronic Devices (CIED) following 3 tesla (3T) MRI~     exposure. This will be achieved by evaluating the changes in pacing capture threshold (PCT)~     measurements following 3T MRI scan exposure. This study is required by FDA as a condition of~     approval of 3T MRI compatible labeling of applicable CIED systems. This study is conducted~     within Medtronic's post-market surveillance platform, the Product Surveillance Registry~     (PSR).~   "
45646|NCT02969382|"~     A study to evaluate the efficacy and safety of an experimental drug (SEP-363856) in acutely~     psychotic adults with schizophrenia~   "
45647|NCT02969369|"~     A study to evaluate the safety and tolerability of SEP363856 in subjects with Parkinson's~     Disease Psychosis~   "
45648|NCT02969356|"~     The purpose of this clinical study is to assess whether AbobotulinumtoxinA (Dysport®)~     injections in upper and lower limbs accompanied with a personal exercise plan called Guided~     Self-rehabilitation Contract (GSC) can improve voluntary movements in subjects with~     hemiparesis.~   "
45649|NCT02969343|"~     The Brigham and Women's Hospital (BWH) Patient Safety Learning Laboratory (PSLL) focuses on~     developing health information technology (HIT) tools to engage patients, family, and~     professional care team members in reliable identification, assessment, and reduction of~     patient safety threats in real-time, before they manifest in actual harm.~   "
45650|NCT02969330|"~     The aims of this study are twofold: (1) to develop an innovative approach for studying brain~     glucose metabolism using functional diffusion weighted imaging (DWI) and BOLD fMRI in humans;~     (2) to evaluate the effect of short peripheral electrical stimulation (PES) treatment on~     brain and brain-stem targets, associated with control of food intake and energy expenditure,~     in response to glucose stimuli, in healthy volunteers.~   "
45651|NCT02969317|"~     The primary objective of this study is to assess the pharmacokinetics of tiotropium +~     olodaterol FDC (5 μg/ 5 μg) delivered by the RESPIMAT inhaler after single dose and at steady~     state in Chinese patients with COPD.~      The secondary objective is to assess the safety of tiotropium + olodaterol FDC (5 μg/ 5 μg)~     delivered by the RESPIMAT inhaler after 3 weeks once daily treatment in Chinese patients with~     COPD.~   "
45652|NCT02969304|"~     The primary objective of this study is to estimate the proportion of DMF use that is~     prescribed on-label versus off-label. The secondary objectives are: To describe the~     demographic characteristics and medical history of DMF users; To describe prescription drug~     history and concomitant medication use of DMF users; To describe the duration of therapy in~     participants newly initiating DMF treatment; To describe the medical specialties of DMF~     prescribers.~   "
45653|NCT02969291|"~     There is a well-documented association between physical activity & risk for breast cancer~     development and recurrence. It is known that exercise interventions have been effective at~     increasing physical activity levels in breast cancer survivors. Knowing that breast cancer~     survivors are less active than non-cancer patients, a less active lifestyle places them at~     risk of obesity and poor overall health, which in turn also increases risk of cancer and~     cancer recurrence. Not all the reasons for the risk reduction are clear, however it is known~     that hormones and other inflammatory markers play a role.~      This study has three goals:~        1. To investigate the feasibility of a home intervention designed to reduce sedentary~          behavior.~        2. Describe the effects of the intervention on levels of sedentary behavior, physical~          activity, and symptoms.~        3. Assess cost of the intervention.~   "
45654|NCT02969278|"~     The study aim is to verify the accuracy of SNB combined with 18F-FDG PET/CT in cN0 invasive~     vulvar cancer (IVC) patients currently not candidate to SNB according to standard guidelines.~   "
45655|NCT02969265|"~     The purpose of this study is to evaluate the efficacy and safety of TCV-116CCB (candesartan~     cilexetil and amlodipine besylate fixed-dose combination) in Chinese participants with mild~     to moderate hypertension who do not reach target blood pressure following 4 weeks of~     treatment with amlodipine monotherapy.~   "
45658|NCT02969226|"~     Background: The sickest patients who are admitted to an intensive care unit (ICU) often~     require assistance with their breathing. When patients start to get better, they gradually do~     more of the breathing and the machine does less—this is called weaning. Although ventilator~     use saves lives, the longer it is used, the more complications can occur. Clinicians aim to~     wean patients from ventilators in a timely and safe manner. In most ICUs, patients are~     screened (looked at) once per day to see if they are ready to undergo a weaning test (using a~     variety of techniques) to see if the breathing tube can be removed. Screening more than once~     per day may allow more weaning tests to be conducted. Knowing the best way to do a weaning~     test is important because some methods may better determine who can have the breathing tube~     removed safely. At present, we don't know the best way to help our sickest patients to wean~     from ventilators.~      Patients: Adults in North American ICUs who are on ventilators for at least 24 hours and who~     can take breaths on their own.~      Interventions: Patients in our study will receive one type of screening and one type of~     weaning test at random. In the 'once daily' screening groups, clinicians will screen patients~     each morning. In the 'two or more times daily screening' groups, patients will be screened in~     the morning, afternoon, and whenever else clinicians wish to screen. When screening criteria~     are met, patients will undergo one of two weaning tests with low ventilator support or no~     support.~      Outcomes: The main outcome of this study will be the time for patients to be successfully~     removed from the ventilator.~      Relevance: For patients, this study will clarify the best way to remove them from ventilators~     in a timely and safe manner. For clinicians and our health care systems, this study holds~     promise to improve how critically ill patients are weaned from breathing machines.~   "
45659|NCT02969213|"~     The purpose of this study is to develop the electronic management platform for children with~     epilepsy, establish large data of Chinese children with epilepsy and explore its biological~     etiology.~   "
45660|NCT02969200|"~     The aim of this study was to investigate renal function decline by measured glomerular~     filtration rate (mGFR) in patients with FD during enzyme replacement therapy, and to explore~     the influence of age on renal function in FD.~   "
45661|NCT02969187|"~     Despite the increasing use of patient-controlled anesthesia (PCA) for postoperative pain~     management, efforts are continuing to find effective methods to relieve pain after abdominal~     surgery. Although opioid is an effective analgesic it has opioid related adverse events~     (ORAEs). Bupivacaine should reduce postoperative pain but it has relatively shorter duration~     of action. Liposome bupivacaine (Exparel) has been approved as a single dose infiltration for~     longer postoperative period analgesic. It provides up to 72 hours analgesia postoperatively;~     results in lesser opioids usage and reduce the ORAEs. Transversus abdominis plane (TAP) block~     is a relatively new regional anesthetic technique. TAP blocks have been performed to reduce~     opioid use and control pain in several laparoscopic surgical procedures, including colorectal~     resections, cholecystectomy and bariatric surgery. The aim of this study is to study the~     opiate usage, pain and nausea post laparoscopic gastric bypass or sleeve gastrectomy using~     Exparel versus Bupivacaine as TAP block and port sites infiltration.~   "
45662|NCT02969174|"~     To establish a genotyping and extraction technology of non invasive prenatal diagnosis for~     fetal blood group genotype from cell-free fetal DNA in peripheral blood of pregnant women.~      To achieve prenatal accurate identification of fetal blood group genotypes，and provide~     credible theoretical evidence for the prenatal diagnosis and treatment of hemolytic disease~     of newborn (HDN).~   "
45663|NCT02969161|"~     This study is to understand how to improve retention in care and treatment services to HIV~     positive pregnant women and their babies in Swaziland. The investigators will evaluate~     outcomes of patients who are lost-to-follow-up (LTF) under a new approach for prevention of~     mother-to-child (PMTCT) called Option B+, where all HIV positive pregnant women initiate~     lifelong antiretroviral therapy (ART) regardless of their disease stage. The goal is to~     understand the outcomes of patients who are LTF from care, and the reasons for disengagement~     from care in the context of PMTCT in order to inform efforts to improve retention in care~     among patients under Option B+.~   "
45664|NCT02969148|"~     To investigate the clinical efficacy and safety of laparoscopic bursectomy and D2~     lymphadenectomy (LBDL group) versus laparoscopic D2 lymphadenectomy (LDL group) in advanced~     gastric cancer by prospective randomized controlled clinical trial.~   "
45665|NCT02969135|"~     Shoulder disorders are extremely common, with a life-time prevalence in population of 30%.~     About 23% of the working population with shoulder problems are sick-listed. Specifically~     rotator cuff tears are considered some of the principal causes of chronic shoulder pain and~     disability, especially with advancing age. The National Patient Register in Denmark has~     registered 730 rotator cuff repairs in 2006 and 990 in 2012, which represents a 35% increase.~      A rotator cuff tear is defined as a rupture of the tendon (s) of the shoulder, and most~     frequently involves the supraspinatus and/or the infraspinatus tendon, resulting in loss of~     function due to pain and tissue weakness. Little is known about the effects of the~     postoperative training/rehabilitation, and this provides an unclear picture of the total~     treatment procedure of this condition.~      The Danish National Clinical Guidelines from 2013 recommend that these patients are offered~     rehabilitation and that the shoulder is immobilized post-surgery, but the evidence for~     postoperative training is moderate- low. The past few years, there have been conducted 5~     systematic reviews looking at different rehabilitation parameters after rotator cuff surgery.~     They conclude that early Range-Of-Motion exercise accelerate healing, reduce stiffness, do~     not increase risk of re-rupture and that immobilization do not increase tendon healing or~     clinical outcome. They also conclude that there is a further need to evaluate approaches that~     foster early initiation of rehabilitation and gradual introduction of functional load in~     high-quality, adequately powered trials, also considering key outcomes such as return to~     work.~      Therefore, the aim of this study is to compare the effect of a progressive early passive and~     active movement protocol with a care as usual (limited early passive movement protocol) on~     tendon healing, physical function, pain, and quality of life, in patients operated due to~     traumatic full thickness rotator cuff tear in a Randomized Controlled Trial.~      Shortterm effects of physical function, pain, and quality of life will be studied as primary~     patient reported outcome, while secondary outcomes will be clinical and paraclinical outcomes~     in addition to the longterm effects of physical function, pain, and quality of life.~   "
45666|NCT02969122|"~     Gastric cancer with positive is defined as stage IV disease in 7th AJCC/UICC TNM staging~     system. Controversy exists on the treatment of this part of patients. This trial aimed to~     explore the optimal treatment strategy for stage IV gastric cancer with positive peritoneal~     cytology as the only non-curable factor.~   "
45667|NCT02969109|"~     A study to validate, in a prospective manner, the ability of the predefined Genomic Health~     bladder cancer assay to detect recurrence in patients undergoing surveillance for non-muscle~     invasive bladder cancer.~   "
45668|NCT02969096|"~     The purpose of this study is to evaluate the safety and efficacy of targeted cryoablation~     therapy for hepatic carcinoma.~   "
45669|NCT02969083|"~     The aim of this study is to explore feasibility of Upper Tract Urothelial Carcinoma (UTUC)~     treatments based in real world data in various European countries. The study will allow to~     gain insight in the true proportion of patients that fit to receive complete cisplatin-based~     neo-adjuvant or adjuvant chemotherapy, and the proportion and clinical outcome of patients~     with poor prognostic factors (PS and renal function) who receive only standard treatment~     (Radical nephroureterectomy (RNU)). This comparison will be made using a uniform diagnostic~     and treatment protocol.~   "
46268|NCT02961257|"~     The purpose of this study is to evaluate the incidence of grade ≥ 3 neutropenia and/or~     neutropenic complications (febrile neutropenia, neutropenic infection) with two schedules of~     cabazitaxel (bi-weekly versus tri-weekly) plus prednisone in elderly men (≥ 70 years) with~     mCRPC previously treated with a docetaxel-containing regimen.~   "
45670|NCT02969070|"~     Hypercholesterolemia is considered one of the most important cardiovascular risk factors.~     Cardiovascular prevention include a class I indication to statins in addition to~     non-pharmacologic intervention and prevention strategies in patients deemed to be 'high~     risk'. Along with non-pharmacologic intervention and prevention strategies, newer approaches~     to reduce cholesterol blood levels currently include nutraceuticals, which are compounds~     derived from foods with cholesterol lowering actions. However, it remains unclear if~     nutraceuticals yield additive positive effects other than cholesterol lowering. In~     particular, there is evidence that Berberine has cardiovascular protective effects and that,~     in vitro, Morus Alba, mulberry fruit, modulates platelet function by inhibiting platelet~     activation, thromboxane formation, serotonin secretion, aggregation and thrombus formation.~     Furthermore, Morus Alba exerts an α-glucosidase inhibitory and antioxidant activity in vitro,~     which may reduce postprandial glucose peak, thus improving HbA1c concentration. Accordingly,~     we designated a study to evaluate the effects of two commercially available nutraceutical~     combined pills [LopiGLIK™, Akademy Pharma, 1 capsule/day containing red yeast rice 220 mg (at~     least 3,3 mg of Monacolin K) + Berberine 531,25 mg + Morus Alba 200 mg (at least 4 mg of~     Deoxynojirimycin) vs. Armolipid Plus®, Meda Pharma, 1 capsule/day containing Berberis~     aristata d.e. 588 mg (equivalent to Berberine chloride 500 mg) + Red yeast rice 200 mg~     (equivalent to Monacolin K 3 mg) + Policosanol 10 mg + Folic acid 0.2 mg + Coenzyme Q10 2.0~     mg + Astaxanthin 0.5 mg] on lipid and metabolic profile, platelet aggregation, endothelial~     function and coronary flow reserve (CFR). For this purpose patients with hypercholesterolemia~     not requiring statins or statin intolerant at moderate cardiovascular risk will be subjected~     at day 0 and at day 28, after 4 weeks of therapy, to blood sampling to evaluate lipid and~     metabolic profile, peripheral arterial tonometry (EndoPAT), platelet aggregation tests with~     light transmission aggregometry (LTA), nitric oxide (NO) release, endothelial nitric oxide~     synthase (eNOS) phosphorylation on platelets. Only for CFR, patients will be further~     evaluated also after two hours from the administration of the first dose of nutraceutical~     combined pill. Patients will be randomly assigned to receive therapy with LopiGLIK™ or with~     Armolipid Plus®.~   "
45671|NCT02969057|"~     The objective of the present study is to compare the effects of liquid or solid state of food~     on glycaemia, lipaemia and insulinaemia. 25 participants aged between 21 and 45 years will be~     recruited from the general public in Singapore. Fingerpricks and cannulation may cause minor~     discomfort and there may be some slight bruising around the site. Fingerpricks and~     cannulation will be done by an experienced research nurse or a trained research officer to~     minimize participant discomfort. If bruising does occur, it should disappear within one day~     and it should not affect participants' regular daily activity. Participants will be limited~     to a maximum of one test per week. In addition, blood collection will be carried out in a~     sterile designated area and thus the risk of infection will be very low. On rare occasions,~     participants may feel unwell during or after the testing session. We have several metabolic~     suites with beds for these individuals to rest on. The research nurse and research officers~     will monitor the individuals' condition and they will be provided with a ride home if~     required. All the study foods will be prepared in a hygienic manner in a purpose-built~     research kitchen maintained to the highest hygiene standards. The research staff has~     undergone basic training in food hygiene procedures. Hence, the risk of infective acute~     gastroenteritis will be minimal. Participants will be provided with some snacks at the end of~     each testing session. They will also be reimbursed to compensate for their time and costs~     associated with travel and parking at the completion of the study. In addition, participants~     will be provided with their blood glucose, blood pressure, and body composition results, with~     a brief interpretation of these at the conclusion of the study.~   "
45672|NCT02969044|"~     This is an 8 week study to assess the efficacy and safety profile of PF-06651600 in~     seropositive subjects with rheumatoid arthritis with an inadequate response to methotrexate~     (up to approximately 50% of subjects may also have had an inadequate response to 1 anti-TNF~     biologic).~   "
45673|NCT02969031|"~     The overarching goal of this project is to improve communication between oncologists and~     their patients by ensuring that the patient's voice is heard in the medical encounter. Thus,~     the hope is to improve the experience for patients living with cancer. The investigators seek~     to accomplish this goal by providing oncologists communication skills training that includes~     feedback on their own audio-recorded conversations. The feedback will come from two sources:~     1) Professional research assistant coders who will identify objective learning opportunities~     based on specific coding criteria and 2) Trained patient reviewers who will listen to the~     recordings and offer their own, subjective feedback at key moments in the encounters.~   "
45674|NCT02969018|"~     The purpose of this study is to determine whether PF-06700841 is safe and effective in the~     treatment of chronic plaque psoriasis.~   "
45675|NCT02969005|"~     Localization of small femur lesions for resection can be challenging and may be associated~     with the need for significant fluoroscopic imaging and tissue dissection.~   "
45676|NCT02968992|"~     The purpose of this study is to investigate how recombinant human lactoferrin (rhLF) which is~     a partially iron saturated form of lactoferrin produced and purified from rice grain may~     improve mobility and memory in older adults with chronic inflammation. Lactoferrin, is a~     known multifunctional protein, and has been shown to have anti-inflammatory effects. A~     recombinant human version of this protein was recently developed and produced from rice. This~     is now available from the Ventria Bioscience Company in a controlled, pharmaceutical grade~     capsule. As part of this double blinded and randomized study, participants will take daily~     dosages of recombinant human lactoferrin (rhLF) or its matched placebo; to measure the~     effects of rhlactoferrin on chronic inflammation and its association with improving mobility~     and memory over a 6 month time period. During the study all participants will be asked to~     provide blood samples and will have physical and cognitive tests administered to them. By~     measuring biomarkers in the blood as well as changes in physical and cognitive measures, the~     investigators will gain an understanding of how rhlactoferrin may safely improve measures of~     chronic inflammation in older adults. As well as a better understanding of whether it has the~     potential to meaningfully influence important measures of physical and cognitive function~     known to be influenced by Chronic Inflammation (CI).~   "
45677|NCT02968979|"~     The purpose of this study is to assess the frequency of cachexia and the management of~     cachexia and associated symptoms in a patient population with non-small cell lung cancer~     (NSCLC).~   "
45695|NCT02968745|"~     Aim: To identify the main occupational performance problems reported by individuals with~     rheumatoid arthritis and the relationship between these activities with work status of~     participants . Methods: the investigators conducted a cross-sectional study with 81 patients~     with RA. Individuals were interviewed the Canadian Occupational Performance Measure. Data was~     described in frequencies and percentages, and the Pearson's chi-square test was used to~     determine the asymptotic association between the occupational performance problems with work.~   "
46269|NCT02961244|"~     Aim of this study is to investigate the efficiency of a standard normothermia protocol and~     effects on postoperative Surgical Site Infection (SSI) rate.~   "
45678|NCT02968966|"~     Genetic epileptic encephalopathies (EEs) are a group of very rare and severe,~     pharmaco-resistant epilepsy forms characterized by an early onset, e.g. first years of life,~     and an often severe developmental delay. Genetic defects were found in different ion channels~     such as potassium or sodium channels explaining well the pathological neuronal~     hyperexcitability leading to seizures. Further mutations were also found in proteins relevant~     for cell structure, DNA/RNA processing or the synaptic vesicular metabolism. Specific and~     individualized therapies have not been established neither in the clinical routine nor in~     controlled studies. The goal of this monocentric non-blinded non-placebo controlled phase IIb~     study is the evaluation of the effectivity of anticonvulsive drugs specifically working on~     the ion channels defective in some subtypes of EEs in order to establish a standard and~     individualized therapy for these rare diseases based on the specific genetic defect.~   "
45679|NCT02968953|"~     This treatment plan is intended for the use of UX007 (triheptanoin) in the treatment of a~     single patient with Glucose Transporter 1 (GLUT1) Deficiency Syndrome.~   "
45680|NCT02968940|"~     The purpose of this study is to test how safe and effective treatment with the combination of~     Avelumab and radiation is for IDH mutant gliomas that have transformed to glioblastoma after~     chemotherapy.~   "
45681|NCT02968927|"~     To examine the safety and preliminary efficacy of multiple adjunctive host directed TB~     therapies (TB HDT), to assess their potential to shorten TB treatment and/or prevent~     permanent lung damage.~   "
45682|NCT02968914|"~     An open-label, single dose Pharmacokinetic (PK) comparability study to demonstrate comparable~     drug exposure following Subcutaneous benralizumab administration by using accessorized~     pre-filled syringe (APFS) or autoinjector (AI) devices.~   "
45683|NCT02968901|"~     The purpose of the study is to document the effect of first line dual oral combination~     therapy with macitentan 10mg and tadalafil 40mg on pulmonary vascular resistance (PVR) in~     treatment-naïve patients with newly diagnosed pulmonary arterial hypertension (PAH).~   "
45684|NCT02968888|"~     The aim of this study is to investigate the acute anabolic effects of native whey, whey~     protein concentrate 80 (WPC-80) and milk after a bout of strength training in young and~     elderly. The investigators hypothesize that native whey will give a greater stimulation of~     muscle protein synthesis and intracellular anabolic signaling than WPC-80, and that WPC-80~     will give a stronger stimulus than milk.~   "
45685|NCT02968875|"~     Alzheimer's disease (AD) is a neurodegenerative disease leading to one of the most common~     forms of dementia in humans and memory disorder is one of the first symptoms that lead to~     diagnosis.~   "
45686|NCT02968862|"~     The study will involve adult patients undergoing elective thoracolumbar-sacral spine surgery~     involving 1-5 spine levels, at the Brigham and Women's hospital that have an anticipated post~     surgical hospital stay of one to three days. These patients will be randomly assigned by the~     BWH Investigational Drug Service to one of three different groups, each consisting of 33~     patients:~      • Group 1 will be patients that will receive epidural hydromorphone 0. 5mg and bupivicaine~     6.25 mg for a total volume of 10 ml.~        -  Group 2 patients will receive hydromorphone 0.5 mg in preservative free saline for a~          total volume of 10ml.~        -  Group 3 patients will receive 10 ml of preservative free saline and this will serve as~          the control group.~   "
45687|NCT02968849|"~     This study will evaluate the preventive vaccine efficacy, safety, and tolerability of~     ALVAC-HIV (vCP2438) + Bivalent Subtype C gp120/MF59 in HIV-seronegative South African adults~     over 24 months and potentially up to 36 months from enrollment.~   "
45688|NCT02968836|"~     Assessment of the Safety and efficacy of an amino acid blend on muscle and gut functionality~     in Intensive Care Unit (ICU) patients.~   "
45689|NCT02968823|"~     Our primary aim is to determine whether licorice gargling provides meaningful analgesia after~     oral surgery. Specifically, we propose to test the primary hypothesis that gargling with~     licorice solution reduces pain after oral surgery more than gargling with sugar water.~     Because effective analgesia can reduce pain and/or opioid consumption, we will jointly~     evaluate verbal response pain scores and overall morphine consumption considering licorice to~     be beneficial only if it proves non-inferior on both measures and superior on at least one.~   "
45690|NCT02968810|"~     This randomized phase II trial studies how well simvastatin works in preventing liver cancer~     in patients with liver cirrhosis. Simvastatin may stop the growth of cancer cells by blocking~     some of the enzymes needed for cell growth.~   "
45691|NCT02968797|"~     SafeSed prototype monitors respiratory parameters by tracking chest movements with optical~     and accelerometer markers. The respiratory parameters are compared to respiratory parameters~     measured by a spirometer and a capnograph.~   "
45692|NCT02968784|"~     This study is intended to show that ExAblate™ MRgFUS is a safe procedure that can~     significantly postpone or eliminate the need of patients with organ confined intermediate~     risk prostate cancer to undergo a definitive treatment (i.e., Radical Prostatectomy or~     Radiation therapy) for their disease.~   "
45693|NCT02968771|"~     The aim of this study is to analyze metabolomic pattern of patients after cardiac stress in~     order to detect differences based on the type of stress (physical or pharmacological with~     adenosine agonists) and result of test (positive or negative for ischemia) and to indentify~     biochemical markers with prognostic value. Clinical data of enrolled patients regarding~     demographics, cardiovascular risk factors, pretest probability and previous cardiovascular~     disease will be recorded. Follow up will be at one, three and five years and will be~     performed by clinical recordings or phone call when necessary. Blood samples of patients~     undergoing myocardial perfusion SPECT (Single Photon Emission Computed Tomography) are taken~     before, immediately after stress and 2h after stress. Serum samples will be analyzed by~     nuclear magnetic resonance in order to know metabolomic profile.~   "
45694|NCT02968758|"~     The primary purpose of this clinical investigation is to verify the performance of the~     GenePOC CDiff test on the GenePOC instrument. This will be achieved by comparing the GenePOC~     CDiff test to the Toxigenic Culture (TC) and cell cytotoxicity neutralisation assay (CCNA), a~     conventional method considered as gold standard for detection of toxigenic Clostridium~     difficile in stool specimens.~   "
45696|NCT02968732|"~     A prospective, investigational study to assess the accuracy of standardized cystoscopic~     evaluation with tissue sampling performed immediately prior to definitive radical cystectomy~     to predict pathologic tumor stage and identify patients who may benefit from bladder~     preservation therapy.~   "
45699|NCT02968693|"~     Fifty-one patients suffering from chronic post-traumatic or postoperative osteomyelitis of~     the lower extremities were included in the retrospective investigation. The patients were~     assigned to the study group of the combination therapy with antibiotic-loaded calcium sulfate~     and antibiotic-loaded PMMA or the control group of the antibiotic-loaded PMMA. Hematological~     parameters, eradication of infection, rate of infection recurrence and reoperation rate were~     evaluated during the follow-up.~   "
45700|NCT02968680|"~     This pilot phase I trial studies how well sonazoid-enhanced ultrasound works in detecting~     sentinel lymph node in patients with cutaneous melanoma. Sonazoid is a contrast agent that~     may make it easier to see if the tumor cells have spread to the sentinel lymph node using an~     ultrasound.~   "
45701|NCT02968667|"~     A randomized controlled trial was conducted from November 2015 and May 2016 with 112~     participants of people diagnosed with schizophrenia. Participants aged 18 years or older with~     Diagnostic Statistical Manual (DSM-V) schizophrenia or schizoaffective disorder from~     outpatient mental health clinics in Jordan, were randomly assigned participants either to~     receive 6 weeks of a booklet form of intervention with face to face discussion, and treatment~     as usual (TAU) (intervention, n = 56), or TAU (control, n = 56). Participants were assessed~     at baseline, immediately post-intervention (post-treatment1) and at three months follow-up.~     The primary outcome measure was change in helplessness score . Secondary outcomes for PDwS~     were psychiatric symptoms, recovery rate and quality of life.~   "
45702|NCT02968654|"~     To compare a liberal and a restrictive strategy to administer blood transfusions in~     critically ill patients with a primary brain injury.~   "
45703|NCT02968641|"~     A Phase 2b, Open-Label, Randomized Study of the Safety, Tolerability, and Pharmacodynamic~     Activity of Lonafarnib With or Without Ritonavir in Patients Chronically Infected with~     Hepatitis Delta Virus~   "
45704|NCT02968628|"~     Alterations in the intrauterine environment can have profound effects on fetal development.~     Diabetes during gestation results in multiple deleterious short-term outcome differences, and~     is correlated with long-term developmental deficits. Multiple studies, in neonates through~     school-aged children, have demonstrated differences in language, attention and psychomotor~     development in offspring of diabetic pregnancies. Neonatal EEG is a promising and~     non-invasive tool for assessment of abnormal brain development or dysmaturity in this~     population. Multiple conventional EEG (cEEG) and amplitude-integrated EEG (aEEG) parameters~     change predictably with advancing gestational development and have been used to differentiate~     between at risk groups in neonatal studies.~      The investigators hypothesize that neonatal EEG can identify brain dysmaturity in infants of~     diabetic mothers (IDMs) compared to gestational-age matched controls. The primary aim is~     documentation of brain dysmaturity in IDMs using cEEG. The secondary aim is establishment of~     aEEG as a more accessible tool to quantify the effects of maternal diabetes on neonatal brain~     development.~      The investigators will conduct a pilot study comparing cEEG and aEEG parameters of cases to~     gestational-age matched controls. Cases will be IDM neonates of at least 35 weeks' gestation~     whose mothers were recommended treatment with either insulin or an oral glycemic agent. Video~     EEG recording will be planned for approximately 60 minutes and obtained between 24 hours and~     5 days of life during birth hospitalization. Additional data will be extracted from maternal~     and neonatal medical records and a maternal questionnaire.~      In addition to evaluating the measures of cEEG and aEEG, this project will establish a~     research cohort. A subsequent study involving developmental evaluations will allow for~     correlation of EEG results with long-term outcomes. The ability to identify those at risk at~     birth would provide the opportunity to intervene in order to mitigate outcome differences,~     particularly in language development. More significantly, we hope to establish neonatal CNS~     outcome measures for future diabetic pregnancy intervention studies. .~   "
45705|NCT02968615|"~     The investigators examined feasibility and acceptability of a non-restrictive diet focused on~     increasing dietary fiber and lean protein for weight loss. Fifteen obese adults enrolled in a~     12-week assessment which included 6 bi-weekly individual dietary counseling sessions to~     attain a daily goal of higher fiber (>35 g/day) and lean protein (0.8 g per kilogram/day of~     individual's ideal body weight).~   "
45706|NCT02968602|"~     Craving for cigarettes is an important aspect that leads to challenges with smoking~     cessation. Persons with schizophrenia are more likely to smoke and to be heavier smokers than~     persons without schizophrenia, and may experience craving differently as well. Minocycline is~     an antibiotic medication that may impact craving. We will conduct a two-week randomized,~     double-blind, placebo-controlled, parallel group pilot study to investigate the effects of~     minocycline vs. placebo on craving and smoking behaviors in smokers with schizophrenia.~     Participants will take minocycline or matching placebo for two weeks. Participants will be~     assessed on aspects of craving and smoking behavior at baseline and after 1 and 2 weeks of~     minocycline or placebo treatment.~   "
45707|NCT02968589|"~     The purpose of this study is to determine if the @ctivehip tele-rehabilitation system~     improves the functional level and quality of life of hip fracture patients and reduce the~     caregiver burden.~   "
45708|NCT02968576|"~     Poor adherence to tenofovir (TDF) and emtricitabine (FTC) for Human Immunodeficiency Virus~     (HIV) pre-exposure prophylaxis (PrEP) is common and the leading cause of therapeutic failure.~     The investigators need better ways to measure adherence in patients on PrEP. This application~     will address the need to measure adherence by evaluating an integrated technology system,~     Proteus Discover, when combined with Truvada. The Proteus Sensor System (PSS) will confirm~     that Truvada was taken, monitor adherence in both recent and long term dosing, and provides~     feedback to encourage adherence. The goal of this study is to determine whether the use of~     the PSS with Truvada will vary the drug concentrations of FTC/TDF. Participants will have 2~     study visits where they will be randomized to either start with the combined PSS with Truvada~     or just Truvada alone. Study participants will come to the Clinical & Translational Research~     Center (CTRC) in the morning and take the assigned dose and will then have blood drawn at~     about .25, 0.5, 1, 2, 4, 6, and 10 hours after medication is taken. Participants will then~     return to the CTRC for blood draws 24, 48, and 72 hours after they took the dose on the first~     day. The second visit will mimic the first except that the participant will take the other~     dose form.~   "
45709|NCT02968563|"~     The primary objective of this study is to determine the preliminary efficacy and safety of~     the combination of tirabrutinib and idelalisib with obinutuzumab in adults with relapsed or~     refractory chronic lymphocytic leukemia (CLL).~      The study has a 6 patient per arm safety run-in to evaluate safety prior to the enrollment of~     subsequent participants. The primary objective is evaluation of efficacy with the secondary~     objective evaluation of safety and evaluation of additional parameters of efficacy. The~     treatment period is adaptive, with a duration of active treatment up to two years and a total~     follow-up on study of 5 years for time-dependent outcome variables.~   "
45710|NCT02968550|"~     . The aim of this study, thus, is to evaluate shunt fraction and markers of alveolar distress~     during one lung ventilation (OLV) at different levels of positive end expiratory pressure~     (PEEP). Moreover, investigators will focus on predicting factors of high shunt levels during~     OLV.~   "
45712|NCT02968524|"~     This project will focus on testing the accuracy of ThermoSpot -a low-cost, color-based,~     temperature indicator in estimating the body temperature of Nigerian babies exposed to~     ambient temperature conditions. The particpants will be recruited among babies receiving~     Filtered Sunlight Phototherapy (FSPT) at Bowen University Teaching Hospital, Ogbomoso and~     other babies in the nursery at Bowen University Teaching Hospital.~      There will also be an educational session to teach health workers and mothers about the signs~     for hypothermia and hyperthermia on the indicator. Then, the investigators will collect~     observational cross-sectional data on random days to see how many of the trained health~     workers and mothers were able to accurately recognize and provide appropriate response to~     warning signs on the indicator.~   "
45713|NCT02968511|"~     The objectives/specific aims of this study are three-fold. First, the study seeks to evaluate~     the safety of fecal microbiota transplant (FMT) in patients with severe, complicated C.~     difficile infection (scCDI). Second, the study seeks to evaluate whether fecal microbiota~     transplant (FMT) can improve scCDI, with improve defined as either decreasing the severity~     of CDI, or by resolving the infection altogether. Third, the study seeks to further study the~     mechanism by which FMT improves the course of scCDI by performing 16S rRNA and ITS sequencing~     on pre-FMT and serial post-FMT stool samples in order to measure changes to bacterial and~     fungal microbiota as a consequence of CDI and FMT therapy. FMT material (hereafter referred~     to as FMTm) would be obtained from OpenBiome. FMTm is prepared from prescreened healthy~     donors.~      The hypothesis of the study is that FMT is a preferred salvage therapy for scCDI as compared~     to (1) ongoing, failing medical therapy with conventional antibiotics and (2) surgery.~   "
45714|NCT02968498|"~     Prospective, open, mono-center, randomized, two part study with 4-way cross-over design in~     each study part.~      The objective of the study is to investigate blood glucose levels after oral intake of~     defined amounts of lactulose.~   "
45715|NCT02968485|"~     This aim of study to assess the safety and tolerability of SHR7390 and to define the maximum~     tolerated dose (MTD) of SHR7390 in the patients with advanced solid tumors.~      To evaluate the pharmacokinetics of SHR7390 in patients with advanced solid tumors.~      To study the effects of food on the pharmacokinetic parameters of SHR7390. To assess the~     antitumor activity of SHR7390 in patients with advanced solid tumors preliminarily and~     recommend reasonable dosage regimen for the follow-up clinical trial.~   "
45716|NCT02968472|"~     A chimeric antigen receptor gene-modified T cells (CART: 4SCAR19)by targeted the CD19~     (cluster of differentiation antigen 19), treat patients with CD19 positive malignant B cells~     tumor, assess treatment safety, and observe therapeutic effects. At the same time,the change~     process of the CART and residual tumor status of the patient are observe dynamically， which~     summarizes the best therapeutic effect.~   "
45717|NCT02968459|"~     This is a single center, randomized, double blind, placebo controlled study to evaluate the~     safety and efficacy of umbilical cord mesenchymal stem cell local intramuscular injection for~     treatment of caesarean section uterine scars.~   "
45718|NCT02968446|"~     The purpose of this research study is to evaluate the effects of an oral Vitamin D on the~     body's immune system.~      An interest has been growing because studies have shown that Vitamin D may reduce~     inflammation and harmful effects in the body, however, the best dose for Vitamin D is still~     unknown.~      Inflammation is the body's physical response to infection, injury, or long term disease.~     Pain, redness, heat, and sometimes loss of function are all signs of inflammation in the~     body. This study will look at product use, testing skin irritation in healthy volunteers and~     seeing how Vitamin D may help stop or reduce inflammation and skin irritation, which could~     one day help doctors prescribe Vitamin D to patients with long term disease to relieve their~     symptoms.~   "
45719|NCT02968433|"~     The purpose of this study is to demonstrate that young plasma infusions can be performed~     safely in patients with Parkinson's Disease (PD). Secondary outcomes will include behavioral~     and laboratory data that will support the next study that will inquire whether young plasma~     infusions improve or slow the progression of cognitive, mood and/or motor impairment and rate~     markers of the disease.~   "
45720|NCT02968420|"~     The overall aim of this study is to further understand the memory response to HPV vaccination~     in subjects who have received 2 versus 3 doses of quadrivalent HPV vaccine. Although memory~     responses can be detected shortly after immunization, the best approach to measure the~     long-lasting anamnestic response is to challenge with a booster dose years (> 5) after the~     original exposure.~   "
45721|NCT02968407|"~     The study group want to investigate whether doctors, who are in the beginning of their~     training to become surgeons, can rate themself and their peers using Objective Structured~     Assessment of Technical Skills. Participants have participated in a 6 weeks course in basic~     open surgical skills. At the end of the course the participants will be examined at at~     videotaped test. The participants will be asked to rate their own video and two videos of~     other trainees' performances. Ratings will be compared to expert ratings.~   "
45722|NCT02968394|"~     The purpose of this study is to evaluate if omalizumab co-treatment may allow reintroduction~     of honey bee venom immunotherapy in patients with immunotherapy treatment failure due to~     systemic reactions.~   "
45723|NCT02968381|"~     Tobacco use is still the leading cause of preventable disease and death in the United States.~     Tobacco quit lines are effective at helping smokers to quit, but quit lines are~     underutilized, especially by men and racial/ethnic minorities. Guided imagery is effective at~     helping people quit smoking, and is appealing to males and diverse racial groups, but has~     limited reach. The proposed study will develop and test the feasibility and acceptability of~     a guided imagery tobacco cessation intervention that is delivered by a combination of quit~     line coaches and an interactive website. The investigators hypothesize that guided mental~     imagery delivered using the quit line coaching model combined with an interactive website~     could be an effective intervention strategy.~   "
45724|NCT02968368|"~     To evaluate the efficacy of oral ferric maltol compared with placebo in the treatment of IDA~     in subjects with CKD~   "
45725|NCT02968355|"~     This study will evaluate the clinical sensitivity and specificity of the FilmArray Global~     Fever (GF) Panel.~   "
45726|NCT02968342|"~     The objective of this study is the role of vaginal progesterone gel in the treatment of~     menopausal hypoactive sexual desire disorder. Half of the study participants will receive a~     standard dose of self applied vaginal progesterone gel and the other half will receive oral~     vitamin tablets.~   "
45727|NCT02968329|"~     Stroke is an important cause of disability and the third leading cause of death.~      Approximately 30 to 40 % of all strokes are estimated to be cryptogenic (i.e. no cause can be~     found). There have been few previous studies regarding risk stratification for stroke~     recurrence in patients with cryptogenic stroke.~      Recent studies have suggested that left atrial (LA) function is an important determinant of~     stroke risk. However, most studies focus on volume indices and LA dimensions, we also want to~     investigate other echocardiographic parameters. The aim of this study is to assess the~     predictive value of left atrial function for the risk of stroke recurrence and/or atrial~     fibrillation by transthoracic echocardiography in cryptogenic stroke patients with no proven~     atrial fibrillation (AF) and no indication for anticoagulants.~   "
45728|NCT02968316|"~     This is a prospective observational study correlating Body Impedance Analysis (BIA) with~     pregnancy outcomes.~   "
45729|NCT02968303|"~     Rationale:~      The combination of ipilimumab and nivolumab induces relatively high response rates and~     promising response depth in late stage melanoma. Nevertheless, it takes time till responses~     occur and still a significant number of patients do not benefit from treatment, due to rapid~     progressive disease or resistance to therapy.~      In contrast to immunotherapies targeted therapies (BRAF or MEK inhibitors), can induce faster~     and higher response rates, but often of shorter duration, even when combined.~      Initial attempts of combining vemurafenib or dabrafenib + trametinib with ipilimumab failed~     due to toxicity.~      Patients with elevated levels of serum LDH are less likely to respond to immunotherapy~     compared to patients with normal LDH levels. This does not mean that such patients do not~     benefit at all from immunotherapy.~      This raises the question, whether response rates upon immunotherapy can be improved by~     upfront reduction of tumor burden and normalization of LDH.~      The investigators postulate that induction therapy with combined BRAF+MEK inhibition, and~     subsequent LDH normalization, can improve response rates to the rates seen in LDH normal~     patients.~      To address this question the investigators have setup a randomized phase 2 trial in~     metastatic melanoma patients with elevated serum LDH comparing the response rates upon~     ipilimumab + nivolumab versus ipilimumab + nivolumab preceded by 6 weeks of vemurafenib +~     cobimetinib induction.~      Furthermore, less than half of the patients treated with the combination of ipilimumab and~     nivolumab received maintenance nivolumab, and approximately 40% of all patients discontinued~     treatment for toxicity. In 70% of patients responses were ongoing despite discontinuation of~     treatment due to toxicity. This raises the question, to what extent does maintenance therapy~     add clinical benefit to an ongoing immune response. Preclinical data indicate even that~     continuous restimulation of T cells can result in activation induced non-responsiveness~     (anergy).~      Therefore, a secondary objective of this trial will be, to test a response-driven nivolumab~     scheme~      Objectives:~      Primary Objective • To compare efficacy of induction vemurafenib + cobimetinib followed by~     ipilimumab + nivolumab (Arm A) versus upfront ipilimumab + nivolumab treatment (Arm B).~      Secondary Objectives~        -  To describe duration of response and overall survival induced by vemurafenib +~          cobimetinib followed by the combination of ipilimumab + nivolumab (Arm A) as compared to~          ipilimumab + nivolumab (Arm B)~        -  To describe the rate and quality of toxicity observed in the two study arms~        -  To describe the rate of ongoing responses upon response-driven flat dose (240mg, q2w)~          nivolumab maintenance~        -  To determine the immune-activating capacity of induction therapy with vemurafenib +~          cobimetinib followed by the combination of ipilimumab + nivolumab.~        -  To evaluate the changes in systemic immune competence~      Study design:~      This is a two-arm phase 2 study consisting of 200 BRAFV600E/K mutation-positive late-stage~     melanoma patients with an elevated baseline LDH level (> ULN, < 3xULN) randomized 1:1~     (stratified according to LDH) to receive either vemurafenib + cobimetinib directly followed~     by ipilimumab + nivolumab (Arm A) or standard first line ipilimumab + nivolumab (Arm B).~     Subsequently, patients in both arms will receive flat dose (240mg, q2w) nivolumab maintenance~     in a response-driven manner.~      Study population:~      Stage IV, or unresectable stage III, BRAFV600E/K mutation positive melanoma patients, naïve~     for BRAF/MEK, PD-1/PD-L1 or CTLA-4 targeting therapy, 18 years and older.~      Intervention:~      Patients will be randomized 1:1 to receive either 6 weeks vemurafenib 960 mg bid +~     cobimetinib 60 mg QD 21-day on, 7-day off (21/7) schedule, directly followed by 4 courses of~     ipilimumab 3mg/kg q3wk + nivolumab 1mg/kg q3wk (Arm A) or first line standard 4 courses of~     ipilimumab 3mg/kg q3wk + nivolumab 1mg/kg q3wk (Arm B).~      Subsequently, patients in both arms will receive nivolumab maintenance flat dose (240mg, q2w)~     in a response-driven manner according to their response at week 18.~      Main study parameters/endpoints:~      Primary Endpoints~      • Compare the best overall response rate (BORR) according to RECIST 1.1 of both arms at week~     18 from start of treatment.~      Secondary Endpoints~        -  Progression-free survival (PFS) according to RECIST 1.1~        -  Overall survival (OS)~        -  Percentage of grade 3/4 toxicities according to CTCv4.03~        -  Percentage of ongoing response, percentage of patients requiring re-induction, response~          percentage upon re-induction~        -  Changes in tumor-specific T cell responses~   "
45730|NCT02968290|"~     The purpose of this study is to quantify the opacity of posterior capsule in pediatric~     cataract comparing two intraocular lens materials.~   "
45731|NCT02968277|"~     The purpose of this project is to evaluate if the LifeWalker Upright walker is improves~     walking and reports of pain compared to a conventional rollator and predicate walker device.~   "
45732|NCT02968264|"~     The aim is to conduct a prospective multi-centre international inception cohort study with an~     enrollment goal of 3,000 TOF patients and 2 year follow-up post-repair. The proposed sample~     size and methodology will result in statistically powerful results to allow for~     evidence-based change to current TOF surgical practices.~   "
45733|NCT02968251|"~     The aim of the study is to design and evaluate a school-based hand washing program for~     children in Malawi, Sub-Saharan Africa, using a cluster randomized controlled trial (CRCT),~     so as to improve proper hand washing, increase knowledge level and also reduce school~     absenteeism.~   "
45734|NCT02968238|"~     Anxiety disorders are the most prevalent psychiatric disorders. Among older adults, anxiety~     is more common that depression, yet research on the nature and treatment of anxiety has~     lagged far behind that of depression. The investigators' work has demonstrated that CBT is~     superior to enhanced usual care as well as supportive therapy in improving worry, depressive~     symptoms, and sleep, and these improvements are maintained for up to 1 year upon completing~     treatment. Research demonstrates that yoga reduces anxiety symptoms and the investigators'~     own work demonstrates that yoga improves sleep. However, no one has conducted a comparative~     effectiveness trial of CBT and yoga for treating worry in older adults. In fact, there are~     very few comparative effectiveness trials for treating late-life anxiety. Thus, clinicians~     are unable to provide an informed recommendation of one treatment over the other. The~     investigators propose a two-stage randomized preference trial comparing 1)~     cognitive-behavioral therapy with 2) yoga for the treatment of worry in a sample of older~     adults. Participants will be randomized to either the preference group (participants choose~     the treatment) or to the random group (participants are randomized to 1 of the 2 treatments).~     This study design allows for the calculation of traditional treatment effects (differences in~     outcomes between participants randomized to either CBT or yoga), selection effects~     (differences in outcomes between participants who choose CBT and those who choose yoga), and~     preference effects (differences in outcomes between participants who choose their treatment~     and those who are randomized to treatment).~   "
45735|NCT02968225|"~     The investigators hypothesize that this serious game (designed to provide a learning~     environment that maximizes opportunities for adolescents with autism to discover the~     functional utility of eye gaze) will improve sensitivity to eye gaze cues, specifically to~     identify gazed-at objects, and will also lead to increased social attention to faces in~     adolescents with autism. The investigators will test this hypothesis in a small-scale~     exploratory randomized control trial that will include both behavioral and eye tracking~     outcome measures.~   "
45736|NCT02968212|"~     The purpose of this study is to evaluate the clinical effectiveness and safety of clofazimine~     when used to treat Mycobacteria avium complex (MAC) lung disease.~      Funding Source - FDA OOPD~   "
45737|NCT02968199|"~     This study describes the development of a community-based network to promote smoking~     cessation among female smokers in Hong Kong.~   "
45738|NCT02968186|"~     The objective of this study is to investigate the efficacy of an implementation program~     specifically designed to increase alcohol screening and brief intervention rates in primary~     health care.~   "
45739|NCT02968173|"~     This is a Phase 3b, prospective, multicenter, open-label, non-controlled study to assess the~     safety and effectiveness of immunoprophylaxis with the intramuscular (IM) administration of~     the liquid formulation of palivizumab for the prevention of RSV hospitalizations in infants~     at high risk (infants born at less than or equal to 35 weeks gestational age and less than or~     equal to 6 months of age at enrollment; or infants less than or equal to 24 months of age~     with a diagnosis of chronic lung disease [CLD] of prematurity requiring on-going medical~     treatment within the previous 6 months or infants less than or equal to 24 months of age with~     hemodynamically significant congenital heart disease [CHD]).~   "
45740|NCT02968160|"~     This is a Randomized, open-label, 2 groups, parallel design.~   "
45741|NCT02968147|"~     ﻿﻿Atrial fibrillation (AF) is a cardiac condition that results in patients experiencing an~     irregular heart beat resulting in symptoms including palpitations and breathlessness. It is~     known that in most cases, AF is caused by abnormal electrical activity from the top of the~     left side of the heart (left atrium) which overrides the heart natural pacemaker in the right~     atrium. Treatment options include tablets which suppress this abnormal electrical activity,~     but in some patients these are not sufficient and a procedure is carried out where the areas~     of abnormal electrical activity are disconnected or 'ablated' to prevent AF from occurring.~     This treatment is well established and performed worldwide, often under general anaesthetic~     (GA). The heart and lungs sit close together in the chest, and when the lungs are inflated~     and deflated during the procedure, the heart also moves. This movement is then transmitted to~     the special wires or 'catheters' that are placed inside the heart to deliver the ablation~     treatment. Instability during the treatment can result in ineffective areas of ablation which~     may later contribute to reduced success of the procedure. Previous research has shown that by~     reducing the movement of the heart under anaesthesia using alternative techniques can improve~     catheter stability and improve procedural results. Once such technique is called high~     frequency jet ventilation (HFJV) which allows the lungs to filled with air using fast and~     shallow breaths resulting in normal blood oxygen levels with little movement in the heart.~     This technique has been shown to be safe and effective for this procedure but a direct~     comparison with conventional ventilation has not been done. The investigators wish to test~     this and determine if using HFJV improves outcomes during the procedure (i.e. can~     investigators do the treatment faster and more effectively) and if this translates to better~     outcomes long term.~   "
45742|NCT02968134|"~     The purpose of this study is to try to find out how critically ill patients receiving the~     anti fungal medication, posaconazole, process it in their body. Investigators would like to~     study if the recommended doses of posaconazole achieve adequate concentrations in the~     patients blood to treat fungal infections.The disease process in critically ill patients can~     profoundly influence the concentration of anti fungal medication in the blood. The process by~     which a drug travels through the body in blood, how it is broken down and removed by the body~     is called pharmacokinetics (PK).~      This information is important to know because if antifungal levels are low in the blood, the~     fungal infection has an opportunity to become resistant to the antifungal medication which~     can lead to the medication being less effective against the fungal infection potentially~     exposing future patients with infection to a limited range of effective antifungals.~      Investigators can measure the PK by taking blood samples at specific times after the anti~     fungal medication is given.~      This study will enroll 8 patients who are admitted to the intensive care unit and are being~     treated with an antifungal medication for a fungal infection. Patients will be consented and~     given a single dose of posaconazole and serial blood samples will be collected just prior to~     the dose and at 15, 45,75 minutes during the infusion and at 3, 5, 8, 12, 18, 24, 30 36 and~     48 hours . Information about the patients stay in the ICU will also be collected including~     blood pressure, temperature, blood test results.~   "
45743|NCT02968121|"~     To determine the pharmacokinetics, safety and tolerability of brexpiprazole administered~     subcutaneously or intramuscularly in adults with schizophrenia.~   "
45744|NCT02968108|"~     The purpose of this study is to evaluate the pharmacokinetics (PK) of ustekinumab in subjects~     from 2 through less than (<) 18 years old in the USA, or 6 through less than (<) 18 years old~     in other countries and determine if it is similar to that observed in adults with moderately~     to severely active Crohn's disease (CD). Also to assess the safety, immunogenicity and~     efficacy of ustekinumab in the treatment of moderately to severely active CD. The main part~     of the study continues to Week 16, at which point all subjects who are receiving benefit from~     ustekinumab maintenance therapy (as determined by the investigator) are eligible to enter the~     long-term extension (LTE) and continue to receive ustekinumab. The study extension ends at~     Week 236.~   "
45745|NCT02968095|"~     The purpose of this research is to test a text message intervention for people who are~     beginning an attempt to quit smoking. The intervention seeks to teach people to think about~     their cravings to smoke in more helpful ways. The investigators expect that participants~     receiving the text message craving program will be less likely to begin smoking again~     compared to participants in a control condition.~   "
45746|NCT02968082|"~     A Single-center, randomized, prospective, experimental, double-blind comparison study for~     effects of preoperative scopolamine patch application on the postoperative nausea and~     vomiting in microvascular decompression surgery~   "
45747|NCT02968069|"~     Without high diagnostic efficacy of endoscopic forceps biopsy (EFB) and with low diagnostic~     efficacy of narrow band imaging (NBI) in novice endoscopists and endoscopists of community~     hospitals in China, it is urgent to improve diagnostic efficacy for gastric cancerous~     lesions.The investigators will conduct a study to develop and validate a diagnostic model~     based on NBI for early gastric cancerous lesions under endoscopic observation.~   "
45748|NCT02968056|"~     There are 10 million atrial fibrillation (AF) patients in China, and the patients are risk of~     stroke, heart failure and sudden death. Persistent AF is still a refractory disease, and~     single catheter ablation only has a success rate around 30-50%. Hybrid strategy consisting of~     thoracoscopic epicardial ablation and transvenous endocardial ablation seems to be an~     attractive procedure to improve the treatment of persistent AF. However, only a few centers~     reported their preliminary results, and the conclusions are controversial. The investigator~     previously reported a minimally invasive surgical ablation from left thoracoscope only and~     achieved good results. Recently, the investigator successfully explored a hybrid procedure~     combing this unique surgical technique and transvenous catheter ablation. Here, the~     investigator present a study to evaluate the efficacy and safety of this novel hybrid~     procedure. The hypothesis is that a hybrid approach is more efficient than surgical ablation~     alone in the treatment of persistent AF.~      This study is a non-randomized controlled study within a single institution. Isolated~     persistent AF patients admitted to the cardiovascular surgery department of Shanghai Xinhua~     Hospital will be screened for enrollment of this study. The study will recruit 180 patients~     in total. Based on their own willingness, the patients will be divided into hybrid group and~     minimally invasive (MIS) group. The MIS group patients only have surgical ablation surgery~     from left thoracoscope as the investigator reported before, while the hybrid group patients~     will have additional transvenous catheter ablation after the surgical ablation is done during~     the same operation. The ratio of hybrid to MIS group is expected to be 1:1, so that each~     group contains 90 patients. The perioperative data is collected, and the patients will be~     followed for 6 months. The primary outcome is the rate of sinus rhythm at 6 months post~     operation. The secondary outcomes include off antiarrhythmic drug rate, perioperative~     complications, major cardiovascular events, stroke, left ventricular systolic function,~     medical expense, serum brain natriuretic peptide level and quality of life. The aim is to~     evaluate the efficacy and safety of this novel hybrid procedure, therefore to provide more~     evidence of the hybrid strategy in the treatment of persistent AF.~   "
45749|NCT02968043|"~     Adolescent idiopathic scoliosis (AIS) has a relatively high prevalence in adolescents.~     Exercise is the most common conservative therapy for mild AIS patients. There are increasing~     evidences suggesting that physiotherapeutic scoliosis specific exercise (PSSE) can halt the~     curve progression. Nevertheless, the evidence concerning PSSE is inadequate and low quality.~     The aim of this study is to identify the efficacy of PSSE on Cobb's angle, rotation angle,~     fall index, pulmonary function, bone quality, and health related quality-of-life (HRQoL) for~     mild AIS patients, and to promote PSSE's application in Shanghai.~      Prior to inclusion, all subjects will be examined by the physiatrists. A parent of each~     subject will be asked to sign an informed consent form before the subject participate in the~     study.~      Eligible subjects will be randomized by a 1:1 allocation ratio by computer either to the~     intervention group, in which they will perform PSSEs; or the control group, in which they~     will perform generalised physiotherapy exercises. All subjects will be assessed at the~     initial visit and 6 months. A multidimensional, comprehensive evaluation including aesthetic~     appearance, radiographic measurement, static balance test, pulmonary function test, bone~     quality, and HRQoL will be used.~   "
45766|NCT02967822|"~     In order to understand the molecular mechanisms leading to Mayer-Rokitansky-Kuster-Hauser~     syndrome (MRKH), the research team has to identify molecular bases of this anomaly.~      Toward this goal, the research team would like to include in the study patients with MRKH~     syndrome, as well as their healthy relatives, in order to perform genetic analyses,~     especially whole exome sequencing.~      This study has been set up in order to collect biological samples from patients with MRKH and~     their relatives.~   "
46440|NCT02959008|"~     Cerebral autoregulation can be explained by a tight coupling between oxygen supply and demand~     of the brain, and is essential to maintain a constant cerebral blood flow (CBF) in the~     context of changes in cerebral perfusion pressure. In this study, investigators use~     Near-infrared spectroscopy (NIRS) to monitor cerebral autoregulation.~   "
45750|NCT02968030|"~     Aging is characterized by functional losses among which, the related to mobility and balance~     may be highlighted. Regular physical activity, including muscle strengthening exercises, is~     beneficial to a healthy elderly. Thus, this study aimed to verify the influence of 8~     weeks-program of lower limbs strengthening exercises in the balance and functional mobility~     of physically active elderly. The investigators evaluated 18 women, with ages between 61 and~     80 years. Balance assessment was performed using the Functional Reach Test (FRT), Timed Up~     and Go (TUG) test and Romberg test in stable or unstable soil. For muscular strengthening of~     the lower limbs, the workload was determined by the strength reached in the eight-repetition~     maximum test (8RM), applying progressive load increments between training sessions conducted~     (50% , 60% , 70% of 8RM), with the muscle strength being reevaluated in the fourth week of~     training, with subsequent adjustment of the load for the subsequent training. The training~     took place in two weekly meetings, in 40-minute sessions, during eight weeks. Data were~     analyzed using the paired-t test and ANOVA with repeated measures. Among 18 evaluated elderly~     women, 7 completed the 8 week training proposed. Decrease in TUG time (p = 0,035) and~     statistically significant increase in muscle strength were observed in all muscle groups~     trained (quadriceps, hamstrings, adductors and abductors). FRT (p = 0.170) was not~     significantly different after training. Therefore, strength training proposed was efficient~     in improving muscle strength in the lower limbs of irregular physically active elderly,~     impacting positively on functional gain gait. However, the gain in muscle strength was not~     enough to generate significant results in static balance probably due to the type of exercise~     performed as well as due being limited to muscle groups of the lower limbs.~   "
45751|NCT02968017|"~     Doppler measurements in the Middle Cerebral Artery (MCA) is a part of the assessment for~     assessing fetal well-being in complicated pregnancy, including Intra Uterine Growth~     Retardation and Fetal Anemia.~      The use of this Doppler measurement in uncomplicated term pregnancies is not a common~     practice due to lack of information. However, several studies use the MCA Pulsatility Index~     (PI) as part of the Cerebro-Placental-Ratio (CPR) measurment at term.~      The purpose of this trial is to assess MCA Doppler variability in term, uncomplicated~     pregnancy.~   "
45752|NCT02968004|"~     This will be an open-label, randomized, multicenter, efficacy and safety study of weekly~     MOD-4023 compared to daily Genotropin therapy in pre-pubertal children with growth hormone~     deficiency.~   "
45753|NCT02967991|"~     Chronic liver disorders (CLD) are a major cause of morbidity and mortality for individuals in~     the US. Though serologic analysis will often lead to a conclusive diagnosis, liver biopsy~     remains an important method for helping to determine the etiology and stage of LD.~     Percutaneous liver biopsy (PLB), transjugular liver biopsy (TLB) and surgical liver biopsy~     (SLB) are alternative methods for obtaining hepatic tissue. In recent years endoscopic~     ultrasound guided-liver biopsy (EUS-LB) has come to the forefront as a safe and effective~     method for obtaining tissue in CLD. There are several studies of the safety of EUS-LB as well~     as the adequacy of specimens obtained in this fashion. Most studies involve a 19-gauge~     needle, therefore in this study the investigators hope to compare the tissue yields of a~     22-gauge fine needle biopsy (FNB) needle, in comparison to conventional 19-gauge. The~     investigators predict that 19 and 22 gauge FNB needle will demonstrate similar diagnostic~     accuracy, with less visible blood artifact. Similarly the investigators predict the safety to~     be equal.~   "
45754|NCT02967978|"~     The study aims at investigating whether the natural calcium isotope ratio (δ44/40Ca) in urine~     and serum differs between postmenopausal women aged 50 to 75 years suffering from~     osteoporosis and a healthy control group and whether δ44/40Ca in urine and serum can be used~     for the diagnosis of osteoporosis or whether further parameters have to be included.~   "
45755|NCT02967965|"~     CARIM is a prospective cohort of 2,000 patients with a first myocardial infarction and~     undergoing reperfusion therapy. Therefore, male and female patients older than 35 years and~     younger than 80 years with onset of chest pain of less than 12 hours who need a primary~     percutaneous coronary intervention (PCI) for a ST elevation segment MI (STEMI) will be~     recruited.~   "
45756|NCT02967952|"~     In this 3-year successive research plan, investigators will conduct a prehospital randomized~     controlled trial to address the following question: In adult patients with non-traumatic~     cause of out-of-hospital cardiac arrest resuscitated by emergency medical technician~     (paramedic level) in the prehospital setting, will receiving endotracheal tube intubation~     cause a better chance of sustained recovery of spontaneous circulation and other survival~     outcomes like neurologically favorable status, comparing to those who receiving supraglottic~     airway device.~   "
45757|NCT02967939|"~     A study demonstrates the non-inferiority of DA-2802 when compared with ㅍViread® in chronic~     hepatitis B patients~   "
45758|NCT02967926|"~     This study aim to evaluated the effectiveness of Digital SpyGlass Cholangioscopy to~     facilitate common bile duct stone removal without fluoroscopy~   "
45759|NCT02967913|"~     The bladder flap at the time of cesarean delivery is the term used to describe the separation~     of the bladder from the lower uterine segment by sharply incising the vesico-uterine~     peritoneum or serosa and using blunt and/or sharp dissection to develop this potential space~     which facilitates placement of a retractor, known as the bladder blade. Creating a bladder~     flap at the time of cesarean delivery is largely based on individual practice patterns and~     practitioners are divided in their use of this step. While creating a bladder flap has a~     theoretical advantage of protecting the bladder from injury, it is unknown whether this step~     has an effect on postoperative bladder function. The purpose of this study was to evaluate~     whether the omission or creation of a bladder flap results in a change in urinary symptoms as~     measured by the UDI-6 component of the PFDI-20.~   "
45760|NCT02967900|"~     An open, non-randomised longitudinal study of diabetic foot ulcers receiving standardised~     treatment, over a 16 week period conducted at out-patient level, utilising novel optical~     wound measurement technologies.~   "
45761|NCT02967887|"~     This study is to assess the efficacy and the safety of hepatic arterial infusion of cisplatin~     and 5-fluorouracil (HAIC) in advanced HCC patients stratified by biomarker expression~     predicting therapeutic response.~   "
45762|NCT02967874|"~     Adipose-derived stromal vascular fraction cells (SVFs) include regenerative cell populations~     (hematopoietic cells, pericytes, endothelial cells and progenitors, stromal/stem cells) and~     thus are potentially important as new therapeutic tools for the repair and regeneration of~     acute and chronically damaged tissues.~      The general objective of this study is to evaluate safety and clinical efficacy of a single~     intra-articular injection of freshly isolated auto-SVFs for the treatment of patients with~     knee osteoarthritis (OA). This study uses autologous adipose-derived SVFs, as therapeutic~     agent and intra-articular administration, as a mode of delivery. Expected clinical effects: a~     treatment reduces pain, increases function and reduces stiffness in the knees of~     osteoarthritic subjects.~   "
45767|NCT02967809|"~     Estimate if the use of a portable cardiac echograph for intra-hospital Emergencie improves~     the performances diagnose in the bed of patient in department of conventional medicine.~      The concordance between the initial medical diagnosis (previous the utilsation of portable~     echograph) and the final diagnosis (after portable echograph utisation) will be evaluated.~     These evaluation will be performed after retrospective review of the medical files~   "
45768|NCT02967796|"~     The aim of the study is to evaluate in primiparous patients the benefit of supplementation~     with Proteochoc® to reduce perineal pain in the postpartum especially, in sitting posture.~     The patient is followed from the delivery to 6 to 8 weeks after.~   "
45769|NCT02967783|"~     The introduction of one dose of the inactivated poliovirus vaccine (IPV) into routine~     immunization schedules in OPV-only using countries as part of the Global Polio Eradication~     Initiative (GPEI) was planned for completion in 2016. However, due to recent developments in~     the global IPV supply landscape, the GPEI polio eradication program is facing a critical~     shortage of the vaccine which is forecast to continue until at least the end of 2017. The~     shortage means that some countries that have already introduced the vaccine, but which are~     considered to be relatively low risk (The Gambia included), will be left without adequate~     supplies and in other countries IPV introduction is being unavoidably delayed.~      Exacerbating the shortage is the need to reserve IPV for future outbreak responses (OBR). The~     current OBR protocol recommends that, if a circulating vaccine-derived poliovirus type 2~     (cVDPV2) outbreak occurs (after the recent global switch from trivalent to bivalent OPV), a~     large scale IPV campaign will be implemented to increase population immunity to the type 2~     poliovirus in an large area surrounding the outbreak as high risk of extending transmission.~      Due to above, dose-sparing through the administration of intra-dermal (ID) fractional (one~     fifth - 0.1mL) doses of IPV (fIPV) has become a very important focus and, for planning~     purposes, there is an urgent need to assess the practical and logistic challenges a country~     such as The Gambia would face in rapidly undertaking an ID fIPV campaign.~   "
45770|NCT02967770|"~     The purpose of this study is to determine whether molecularly tailored therapy can improve~     the efficacy of treatment when compared to standard chemotherapy combinations for patients~     with metastatic pancreatic cancer receiving their second line of therapy for metastatic~     disease.~   "
45771|NCT02967757|"~     This study is conducted in Europe. The aim of this study is to investigate usage of~     liraglutide for weight management in clinical practice.~   "
45772|NCT02967744|"~     The study investigates associations between pre treatment pain intensity and central pain~     mechanisms on the effect of 8-week treatment of NSAIDs in patients with knee osteoarthritis.~   "
45773|NCT02967731|"~     This is a Phase I, exploratory safety study of the 480 Biomedical Mometasone Furoate Sinus~     Drug Depot in adult subjects with chronic sinusitis.~   "
45774|NCT02967718|"~     Coronary heart disease is still the major cause of death in China. Chinese medicine plays~     more and more important role in CHD prevention and treatment. Phlegm and blood stasis are its~     major pathological basis. Based on that, the investigator aims to evaluate the evolutionary~     process of CHD phlegm-blood stasis syndrome by large samples, multi-centre, cross-section~     observation combining with longitudinal tracking on-site survey method so as to guide the~     clinical treatment of CHD.~   "
45775|NCT02967705|"~     This cluster randomized waiting-list controlled pilot study will evaluate the effectiveness~     of pain management group activity organized by the OH on pain intensity and associated~     disability, and co-occurrence of mental or sleep problem in patients with chronic pain.~   "
45776|NCT02967692|"~     To evaluate the safety and efficacy of the combination of an anti-PD-1 antibody (PDR001), a~     BRAF inhibitor (dabrafenib) and a MEK inhibitor (trametinib) in unresectable or metastatic~     BRAF V600 mutant melanoma~   "
45777|NCT02967679|"~     The primary objective of the study is to assess the effect of MD1003 on motor and sensory~     conduction, in patients suffering from demyelinating polyneuropathies.~   "
45778|NCT02967666|"~     PET/MRI (positron emission tomography/magnetic resonance imaging) with somatostatin analog~     tracers has the potential to provide an imaging technique targeting subclinical granulomatous~     disease in those with latent tuberculosis (TB), allowing identification of individuals who~     may be at risk of progression to active TB.~   "
45779|NCT02967653|"~     Lithium remains the gold-standard treatment for bipolar disorder, with 30-40% of patients~     with responding preferentially to this medication. Additionally, lithium is commonly used in~     treatment-resistant depression, and other psychiatric disorders (e.g. schizoaffective~     disorder). Lithium is especially valuable considering the great difficulty in achieving and~     maintaining symptomatic remission, the high rates of disability, as well as tremendous~     personal, family, and societal costs associated with bipolar disorder and treatment-resistant~     depression. Despite this, clinicians are increasingly avoiding lithium, largely due to fear~     of irreversible chronic kidney disease (CKD), particularly in North America.~      It is well known that lithium exposure, even when dosed safely (<1.0mmol/L in adults 11 and~     <0.8mmol/L in geriatric patients 12,13), can increase the risk of CKD by 3 times, in large~     part through Nephrogenic Diabetes Insipidus (NDI) 14-19. NDI itself has also been associated~     with acute kidney injury 20, and life-threatening hypernatremia, which is an electrolyte~     imbalance characterized by high levels of blood sodium. Aside from hypertension, diabetes~     mellitus, aging, and other nonspecific CKD risk factors.~      NDI is characterized by excessive thirst (polydipsia) due to increased production of dilute~     urine (polyuria). In NDI, lithium is believed to interact with the inositol monophosphate and~     protein kinase C pathways, thereby affecting calcium-related intracellular signaling, cyclic~     AMP (cAMP), inhibition of Glycogen Synthase Kinase-3 Beta (GSK3Beta), activation of MAP~     Kinase and many other pathways.~      NDI occurs commonly in lithium users: 50% of chronic lithium users have urinary concentrating~     difficulties, with 12-19% have decreased urine osmolality (UOsm) <300mOsm/Kg).~      To date, amiloride (5-20mg/day) is the only medication with prior evidence of therapeutic~     effectiveness in NDI from randomized clinical trials. However as a potassium-sparing diuretic~     31, amiloride can lead to lithium-level elevations, and can thereby theoretically increase~     the risk of lithium-associated CNS and acute renal toxicity.~      There is a need for novel, well-tolerated agents for the treatment of lithium-induced NDI.~      We recently demonstrated that statins, which are well-tolerated and commonly used~     medications, are associated with low lithium-induced NDI risk in the first and only previous~     cross-sectional study examining statins and NDI in humans (n=71) 33. In this study we~     examined current lithium users aged 20-95, who had a mean lithium duration and serum lithium~     level of 10.6 years and 0.62mmol/L, respectively. Patients were assessed for UOsm following~     10-hour water-restriction, a reliable measure of NDI. We found that 0% (0/17) of statin users~     compared to 20.4% (11/54) on non-users had UOsm <300mOsm/Kg following 10-hour~     water-restriction (Fisher's Exact p=0.055). The main statin prescribed in our previous study~     was atorvastatin 10-40mg/day (n=10) 33, which is the most widely used statin for~     cardiovascular disease. Atorvastatin and other statins are well-tolerated and have not been~     found to have adverse effects on mood, cognition, or renal function.~      The mechanism by which statins may treat NDI is not yet known, but two independent mice~     studies have demonstrated the effectiveness of statins in treating genetic forms of NDI. In~     those mice models of genetic NDI, prostaglandin and intracellular cytoskeleton proteins~     pathways were thought to explain statins' activity on NDI.~      In preparation for this project, our co-investigators Drs. Trepiccione and Christensen have~     initiated a pilot study in mice to investigate whether atorvastatin treatment could improve~     the lithium-induced NDI. NDI was induced in 10 mice by feeding mice with a LiCl-enriched diet~     for 15 days. After induction of NDI, a group of mice received intraperitoneal injection of~     atorvastatin (n=5) and a control group received vehicle (n=5) for additional 5 days in~     parallel with continued lithium treatment. Although our small statistical sample do not allow~     us to reach significance, (n=5 per group), the mice receiving atorvastatin showed a tendency~     to reduce polyuria.~      In line with this research, our present research protocol aims at conducting a randomized~     controlled trial investigating a statin, such as atorvastatin, in the treatment of~     lithium-induced NDI.~   "
45780|NCT02967640|"~     The hypothesis of the present study is that in patients with rotator cuff tendinopathy a~     specific pharmacological blocking of peripheral glutamate-receptor N-methyl-d-aspartate~     receptor type1 (NMDAR) glutamate receptors will result in pain alleviation. Activated NMDAR1~     has been demonstrated to be crucial for pain regulation in various pain disorders, and in~     biopsies from patients with tendinopathy, NMDAR1 was found to be activated.~      To test this hypothesis a specific NMDA receptor antagonist, ketalar (ketamine), will be~     injected guided by ultrasound into the subacromial space in patients with rotator cuff~     tendinopathy, and subsequently the pain response will be assessed.~   "
45781|NCT02967627|"~     Surgical Site Infections (SSIs) and wound complications are common occurrences following~     colorectal resection surgery. Incisional Negative Pressure Wound Therapy (iNPWT) has~     developing evidence for improving wound complication rates in certain populations. However,~     there have been no RCTs to date that have looked at iNPWT use after colorectal surgery. We~     propose a study in which patients are randomized into one of two treatment arms: 1)~     incisional NPWT, and 2) standard sterile gauze dressings. Patients will be followed for 30~     days for diagnosis of infection or wound complication. We will compare primary outcomes in~     each group using Chi-Squared statistical testing in order to report a Absolute Risk Reduction~     and Number Needed to Treat~   "
45782|NCT02967614|"~     To assess the pharmacokinetic Interaction between Dorzolamide and Brimonidine in healthy male~     subjects.~   "
45793|NCT02967471|"~     Acute respiratory distress syndrome (ARDS) has a very poor prognosis and high mortality. To~     improve the early diagnosis of ARDS, there is an urgent need for novel biomarkers of ARDS.~     This project aims to detect novel biomarkers from peripheral blood , which can improve the~     early diagnosis and develop a more efficient therapy to enhance ARDS patient survival rate.~     Clinical data and blood sample were recorded before treatment and after treatment. Acute~     Physiology And Chronic Health Evaluation III (APACHE III) scores were calculated at~     enrolment. Different kinds of lymphocytes from blood samples would be detected by flow~     cytometry ,which could be used for discovering high sensitivity and specificity ARDS~     biomarker.~   "
45783|NCT02967601|"~     Background Shivering occurs in circa 50 percent of cases during caesarean section under~     spinal anesthesia. The phenomenon's reasons and its mechanism are unclear, and while it does~     not endanger the patients' health, the sensations proved to be unpleasant and a subject of a~     number of patients' complains.~      Objectives The main objective of the study is to establish the anxiety factors that influence~     the risk of muscle-shivering and a detailed assessment of the probability of existence of the~     link between increased anxiety levels with the shivering in case of patients undergoing the~     elective caesarean section.~      Moreover, the outcomes of the study could help to further understand the phenomenon, reduce~     its occurence and as a result of that - improve the comfort of the patients in the~     perioperative period, as well as reduce the frequency of pharmacological treatment to halt~     the symptoms of muscle shivering.~      Methodology Patients would be asked to fill the STAI (State - Trait Anxiety Inventory)~     questionaire in the morning preceding the surgery. Results would be interpreted by one of the~     investigators, who obtained a masters degree in psychology. Caesarean section under spinal~     anesthesia would be performed according to standard procedures used in the Samodzielny~     Publiczny Szpital Kliniczny Centrum Medyczne Kształcenia Podyplomowego (SPSK CMKP) hospital,~     with standard non-invasive monitoring (HR, noninvasive blood pressure (NIBP), oxygen~     saturation (SpO2), Temperature). Additionally, the anesthesiologist would note the incidence~     of shivering and its precise timing 1. since the spinal block 2. since the child-birth.~     Moreover, patients would rate anesthesiology team influence on her anxiety level during the~     cesarean section in 5 grade scale - data would be collected by psychologist.~      The survey is planned for a one year timespan or until 200 patients have enrolled.~   "
45784|NCT02967588|"~     Background Medication adherence following acute coronary syndrome (ACS) is often sub-optimal~     and is associated with poor clinical outcomes. Non-adherence can be considered intentional or~     unintentional. Findings ways to improve adherence is an important area of research with~     widespread clinical implications, however, previous interventions have generally been~     ineffective. The investigators propose an intervention that challenges both intentional and~     unintentional non-adherence in patients hospitalised following ACS.~      Objectives The objective of this study is to determine the feasibility of a hospital-based~     intervention aimed at supporting medication adherence in patients following an ACS.~      Methods Patients admitted to hospital with an ACS will be recruited for this study. The study~     will target both intentional and unintentional non-adherence over two sessions through~     challenging treatment beliefs and formulating specific action plans to encourage habit~     formation. Patients will be asked to provide in-depth feedback around the acceptability of~     the intervention. As this is a feasibility study, outcomes (i.e. medication adherence) will~     not be collected.~      Dissemination If this study seems to be practical to deliver and acceptable to patients then~     it will inform the design of a future randomized-controlled pilot study to test the~     effectiveness of the intervention delivered by hospital pharmacists on a study outcome (i.e.~     medication adherence).~   "
45785|NCT02967575|"~     This Post Market Clinical Follow-up (PMCF) is conducted to collect clinical and radiographic~     outcome information on patients suffering from intractable symptomatic cervical disc disease~     requiring 1- or 2-level reconstruction of the disc from C3-C7, after being treated with the~     Triadyme-C polycrystalline diamond compact cervical disc replacement.~   "
45786|NCT02967562|"~     This study compares a fifteen second sustained inflation (SI) to five repeated two - three~     second 'inflation breaths' during resuscitation at delivery of infants born prematurely.~   "
45787|NCT02967549|"~     This study aims to assess whether neurally adjusted ventilatory assist or proportional assist~     ventilation is more effective in infants born prematurely with evolving or established~     bronchopulmonary dysplasia~   "
45788|NCT02967536|"~     Our multi-disciplinary research group works closely with people who have obstructive sleep~     apnoea (OSA). This is a life-long illness that causes breathing to stop during sleep, which~     leads to low-oxygen in the blood. Breathing restarts when the airway at the back of the~     throat reopens, usually during arousal from sleep. In some people the repeated arousals from~     sleep cause daytime sleepiness. Our research has shown that the low blood oxygen levels~     affect thinking and feeling, and in some cases we think it damages the brain cells involved~     with memory, attention, emotions and decision-making.~      This study will investigate the relationship between the amount of oxygen in the blood and~     the loss (if any) of brain cells. Also how the ability to perform complex tasks is affected~     in patients that suffer from sleep apnoea. The results will show whether the brain damage in~     patients with sleep apnoea can be reversed with treatment. These findings will guide doctors~     in the treatment for sleep apnoea and they will cast light onto the process of memory decline~     with the aim to preserve brain function.~   "
45789|NCT02967523|"~     This project involves the collection and analysis of retrospective and prospective data on~     patients diagnosed with hepatocellular carcinoma (HCC) in which the Surefire Precision~     Infusion System was used/will used be to deliver transarterial chemoembolization with~     doxorubicin-eluting beads (DEB-TACE). The purpose is to compare tumor and medical response in~     a real-world setting as well as identify potential areas for future clinical research.~   "
45790|NCT02967510|"~     A Phase 2, Dose-ranging, 12-week Randomized, Double-blind, Placebo controlled, Parallel-group~     Study Evaluating the Efficacy and Safety of Three Formulations of Ultra-low Dose Estriol~     Vaginal Gel (0.005% Estriol Vaginal Gel, 0.002% Estriol Vaginal Gel, 0.0008% Estriol Vaginal~     Gel) for the Treatment of Vaginal Dryness in Postmenopausal Women with Vulvovaginal Atrophy.~      Vulvovaginal atrophy is a natural consequence of the progressive estrogen deficiency that~     occurs in menopause. Epidemiological data have indicated that about 50% of otherwise healthy~     women over 60 years of age experience symptoms related to urogenital atrophy such as vaginal~     dryness, dyspareunia, burning, itching, as well as urinary complaints or infections of the~     lower urinary tract. As these alterations frequently affect the quality of life of~     postmenopausal women, it is important for doctors to detect their presence and offer~     treatment options. Estrogen therapy is the most effective treatment of moderate to severe~     symptoms of vulvar and vaginal atrophy. One advantage of local treatment with estrogen is~     avoidance of first-pass liver metabolism, making it possible to use lower doses of estrogen~     compared with oral therapy; the local route also minimize systemic adverse effects. The~     search for therapeutic alternatives which may present improvements in relation to the current~     products has been encouraged.~   "
45791|NCT02967497|"~     This randomized pilot phase II trial studies the effect of YQ1, a herbal medicine, with~     cisplatin-based chemotherapy on gut microbiota and immune response in patients with EGFR/ALK~     wild type non-small cell lung cancer, stage IIIB-IV.~   "
45792|NCT02967484|"~     This study evaluate the effects of acupuncture method on the recurrence of ischemic stroke~     patients.Half of participants will receive Huo Xue San Feng acupuncture combining 1~     antihypertensive medication on the routine ischemic stroke treatments' basis. While the other~     half will receive 1 antihypertensive medication and basic treatments for ischemic stroke.~   "
45794|NCT02967458|"~     This is a phase II single center study using contrast-enhanced ultrasound to identify~     aggressive forms of prostate cancer with subharmonic imaging.~      The following are the study objectives:~        1. To implement subharmonic imaging technology on a transrectal probe suitable for prostate~          imaging and biopsy~        2. To demonstrate visualization of prostatic vascularity using subharmonic~          contrast-enhanced imaging.~        3. To provide a preliminary estimate of the diagnostic accuracy of contrast-enhanced~          subharmonic imaging for detection of clinically significant PCa.~      The study will include 50 subjects who are scheduled for prostate biopsy. Each subject will~     receive an intravenous infusion of microbubble contrast material immediately prior to a~     prostate biopsy procedure. The study will demonstrate whether subharmonic imaging with a~     microbubble contrast agent allows for detection of clinically significant prostate cancer.~   "
45795|NCT02967445|"~     Cervical insufficiency, previously referred to as cervical incompetence, has classically been~     defined as painless dilation of the cervix in the absence of contractions or bleeding in the~     second trimester resulting in recurrent pregnancy losses. Painless mid-trimester cervical~     dilation is an uncommon finding in the general population occurring in less than 1% of~     pregnancies. Cerclage for the prevention pregnancy loss in cases with both prior preterm~     births and/or second trimester losses, as well as second trimester cervical dilatation in the~     index pregnancy, was first reported in the 1950's. Cerclage placement in this setting has~     been variably referred to as physical exam-indicated cerclage, rescue cerclage, and~     emergency cerclage. To date, the benefits of cerclage for this indication are not entirely~     clear.~      A recent meta-analysis showed that physical exam-indicated cerclage is associated with a~     reduction in perinatal mortality and prolongation of pregnancy when compared to no such~     cerclage.~      Recently, several RCTs have shown that cervical pessary could decrease the incidence of PTB~     in several populations.~      Thus, the aim of our trial as noninferiority trial is to evaluate the efficacy of pessary~     compared to cervical cerclage in prevention of PTB in women in the setting of mid-trimester~     cervical dilation~   "
45796|NCT02967432|"~     The purpose of this study is to determine whether or not mupirocin treatment results in S.~     aureus decolonization in affected NICU patients.~   "
45797|NCT02967419|"~     The purpose of this study is to find out the possible relationship among TWEAK/Fn14,~     JAK/STAT3 and IDO as well as their roles in the dysfunction of immune micro-environment of~     endometrium in people diagnosed as repeated implantation failure after in vitro~     Fertilization-embryo transfer(IVF-ET).~      We will use the technology of Western-blot and Immunohistochemistry to find out the~     relationship of the expression of TWEAK/Fn14, JAK/STAT3 and IDO in endometrium . Also, we~     will use technology of Western-blot and Immunohistochemistry to determine whether there are~     differences of the the expression of TWEAK/Fn14, JAK/STAT3 and IDO in endometrium between RIF~     group and control group.~   "
45798|NCT02967406|"~     This is a community-based cluster randomized control trial aimed to investigate the impact of~     lifestyle modification (diet, physical activity, alcohol drinking and smoking) on the~     development of dementia, diabetes, chronic kidney disease, cancers, chronic obstructive~     pulmonary disease and cardiovascular disease in an intermediate risk population in mixed~     urban-rural areas of Ubon Ratchathani.~   "
45799|NCT02967393|"~     This study is designed to note whether a larger safety study using quadrivalent live~     attenuated influenza vaccine (LAIV4) versus quadrivalent inactivated influenza vaccine~     (IIV4)(FLUARIX®), would be feasible in children with persistent asthma. Half of the patients~     in this study will receive the FLUARIX® influenza vaccine, while the other half will receive~     a cell cultured quadrivalent inactivated influenza vaccine (ccIIV4)(Flucelvax®) being used as~     a surrogate for LAIV4.~   "
45800|NCT02967380|"~     This pilot clinical trial compares gadobutrol with standard of care contrast agents,~     gadopentetate dimeglumine or gadobenate dimeglumine, before dynamic contrast-enhanced~     (DCE)-magnetic resonance imaging (MRI) in diagnosing patients with multiple sclerosis, grade~     II-IV glioma, or tumors that have spread to the brain. Gadobutrol is a type of contrast agent~     that may increase DCE-MRI sensitivity for the detection of tumors or other diseases of the~     central nervous system. It is not yet known whether gadobutrol is more effective than~     standard of care contrast agents before DCE-MRI in diagnosing patients with multiple~     sclerosis, grade II-IV glioma, or tumors that have spread to the brain.~   "
45801|NCT02967367|"~     During last years, numerous sleep trackers have been commercialized. They are intended to~     give indications about sleep quality/duration in order to give people an internet-based~     feedback about their own sleep.~      For clinical and research purposes, tri-axial accelerometers/multi-sensors devices are used~     routinely to assess objective sleep quality/patterns. Their use is also validated to estimate~     sleep in obstructive sleep apnea syndrome (OSA).~      The purpose of the present study is to compare the accuracy of consumer-level sleep trackers~     and validated tools to measure sleep in OSA patients.~   "
45802|NCT02967354|"~     Cross-sectional study to investigate subjects at different stages of type 2 diabetes~     development with expected stratification of pancreatic islet mass. Non-diabetic individuals~     were assigned as control. The primary outcome was the [11C]5-hydroxy-tryptophan uptake and~     retention in the pancreas as a surrogate marker for the endogenous islet mass.~   "
45803|NCT02967341|"~     To validate blood draws via a central venous catheter (Port A Cath ®) for pharmacokinetic~     studies of ciprofloxacin in patients under treatment for childhood cancer.~   "
45804|NCT02967328|"~     Immature platelets—also termed reticulated platelets (RP)—are platelets newly released into~     the circulation, and have been associated with a variety of pathological bleeding events~     including primary immune thrombocytopenia (ITP). They can be assessed by flow cytometry (FCM)~     after staining with thiazole orange (TO) at low concentration and expressed as a fraction of~     the total platelet count (RP%). The diagnosis of primary ITP is based on differential~     diagnosis and the measurement of RP% can serve as an alternative diagnostic test that are~     useful in daily practice. Our study aimed at distinguishing primary ITP from other~     thrombocytopenic disorders, especially aplstic (hypoplastic) or chemotherapy-induced~     thrombocytopenia by FCM. The sensitivity and specificity of the assay as well as agreement~     between RP% measurement and monoclonal antibody-specific immobilization of platelet antigen~     (MAIPA) were analyzed accordingly.~   "
45805|NCT02967315|"~     The purpose of this study is to evaluate the correlation between fluid volume status and~     right ventricular volume and function, in those with free pulmonary valve insufficiency after~     Tetralogy of Fallot (TOF) repair.~   "
45806|NCT02967302|"~     To investigate pain and inflammatory parameters (cytokines, immune cells) in knee joint~     tissue of chronic arthritis patients following intraarticular (i.a.) injections of morphine,~     a standard steroid or placebo.~      The primary hypothesis is that i.a. morphine results in significantly lower pain scores and~     supplemental analgesic consumption than placebo during the first week after injection, an~     efficacy comparable to standard i.a. steroid (triamcinolone) medication.~   "
45807|NCT02967289|"~     The trial is a phase III, multicenter, open-labeled randomized trial comparing the~     association 5-fluorouracil, folinic acid, irinotecan and oxaliplatin (mFOLFIRINOX) versus~     oxaliplatin, folinic acid, 5FU (mFOLFOX 6) chemotherapy protocols in patients with high-risk~     stage III colon cancer in the adjuvant setting.~   "
45808|NCT02967276|"~     This phase II trial study assessing the activity of metformin when given together with high~     dose of dexamethasone in treating patients with multiple myeloma (MM) that has relapse or~     refractory to previous treatment. High dose of dexamethasone (HDdexa) is used to treat~     relapse/refractary patients with myeloma and metformin also demonstrated synergistic activity~     with dexamethasone to eradicate MM cells in vitro and in vivo. Metformin hydrochloride, used~     for diabetes, may also help kill tumor cells. Giving dexamethasone with metformin may kill~     more MM cells and increase the response rate to HDdexa.~   "
45809|NCT02967263|"~     -  To investigate the etiology and epidemiology of acute kidney injury (AKI).~        -  To find out risk factors associated with the occurence of AKI.~        -  To find out risk factors related to the prognosis of AKI,focusing on uremic toxins,~          inflammation, oxidative stress and nutritional status.~        -  To study on the relationship between gene polymorphism and prognosis of acute kidney~          injury.~   "
45810|NCT02967250|"~     The objective of this study is to understand the bioenergetic impairments that underlie~     Parkinson's disease (PD) and evaluating treatments that may improve abnormal mitochondrial~     function that is present in PD. The hypothesis is that repeated oral dosing of UDCA will~     result in increased brain ATP levels in individuals with Parkinson's disease (PD). The~     specific aims are 1.) to measure plasma UDCA levels in individuals with PD at baseline and~     after four weeks of repeated high doses of oral UDCA (50mg/kg/day) and 2.) to measure~     cortical bioenergetic profile and ATPase activity (as ascertained through MRS) in those with~     PD at baseline and at four weeks after repeated high doses of oral UDCA (50mg/kg/day)~     simultaneously. Secondary aims are to characterize oral UDCA pharmacokinetics and develop a~     pharmacokinetic/pharmacodynamic model to characterize the relationship between peripheral~     measurements of UDCA (and associated conjugates) and peripheral measures and/or central~     (brain) bioenergetic measurements.~   "
45811|NCT02967237|"~     Primary Objective:~      The primary objective is to describe the effect of insulin glargine (U300) in type 2 diabetes~     mellitus (T2DM) patients uncontrolled with their current basal insulin therapy and eligible~     for basal switching, according to the Physician decision, on glycated hemoglobin (HbA1c)~     improvement.~      Secondary Objectives:~        -  Evolution of fasting plasma glucose~        -  Evolution of insulin dose and body weight~        -  Hypoglycemia incidence~        -  Safety~        -  Patients satisfaction when they change their insulin for HOE901-U300~   "
45812|NCT02967224|"~     Primary Objective:~      To demonstrate noninferiority of Toujeo versus standard of care basal insulin therapy~     measured as glycosylated hemoglobin (HbA1c) change~      Secondary Objectives:~        -  To demonstrate superiority of Toujeo versus standard of care basal insulin if~          noninferiority is met, measured as HbA1c change.~        -  To compare Toujeo to other standard of care basal insulin in terms of patient~          persistence with assigned basal insulin therapy with or without intensification.~        -  Risk of hypoglycemia including the incidence of documented symptomatic or severe~          hypoglycemic events [as defined by the American Diabetes Association (ADA] Workgroup on~          Hypoglycemia).~        -  Change in fasting plasma glucose (FPG).~        -  Change in body weight.~        -  Differences in patient reported outcomes measured by Diabetes Treatment Satisfaction~          Questionnaire Status and Change Versions (DTSQs and DTSQc).~        -  Change in hypoglycemic control subscale (HCS)~        -  Healthcare resource utilization including hospitalizations and emergency department or~          other health care provider visits and healthcare costs.~   "
45813|NCT02967211|"~     Primary Objective:~      To demonstrate noninferiority of Toujeo versus standard of care basal insulin therapy as~     measured by glycated hemoglobin (HbA1c) change~      Secondary Objectives:~        -  To demonstrate superiority of Toujeo versus standard of care basal insulin if~          non-inferiority criterion is met, measured by HbA1c change.~        -  To compare Toujeo to other standard of care basal insulin in terms of patient~          persistence with assigned basal insulin therapy with or without intensification.~        -  Risk of hypoglycemia including documented, symptomatic hypoglycemia (≤70 mg/dL) or~          severe (according to ADA Working Group).~        -  Change in fasting plasma glucose (FPG).~        -  Change in body weight.~        -  Differences in patient reported outcomes measured by Diabetes Treatment Satisfaction~          Questionnaire Status and Change versions (DTSQs and DTSQc).~        -  Change in hypoglycemic control subscale (HCS).~        -  Healthcare resource utilization including hospitalizations and emergency department or~          other health care provider visits and healthcare costs.~   "
45814|NCT02967198|"~     The purpose of this study is to determine whether fusion technique of preradiofrequency~     ablation (RFA) or percutaneous liver biopsy cross-sectional imaging (CT or MR) and real-time~     ultrasonography would improve feasibility of RFA or liver biopsy in patients with liver tumor~     in comparison with ultrasonography guidance alone. And assessment of a new point shear-wave~     elastography method (pSWE, S-shear wave) and compare its accuracy in assessing liver~     stiffness (LS) with another pSWE technique (ARFI).~   "
45815|NCT02967185|"~     The proposed study will examine changes in older insomniacs' cognitive functioning following~     behavioral treatment for insomnia using a combination of two methods. A traditional repeated~     measures design will be used to look at group level differences based on performance on a~     neuropsychological battery administered prior to, immediately after, and 3 months after~     completing a 4 week behavioral treatment program for insomnia. This data will be analyzed~     using standard repeated measures analytic techniques. A time-series design will also be used~     to look at within-subject differences based on a brief cognitive battery that will be~     self-administered on a daily basis. Data from this daily battery will be examined using~     intraindividual variability modeling.~   "
45816|NCT02967172|"~     The purpose of this study is to determine the efficacy and safety of a peri-articular~     multimodal injection for post-operative pain control following operative management of~     closed, rotational ankle fractures. Enrolled subjects will be randomized to either receive or~     not receive intra-operative injections in addition to standard opioid analgesic regimens.~     Patients will be treated with standard of care surgical techniques by the treating~     orthopaedic surgeon for the patient's specific fracture pattern. The patients randomized into~     the injection cohort will receive a 25cc intra-operative injection with 200 mg ropivacaine,~     0.6 mg epinephrine, 5 mg and morphine into the local superficial and deep peri-incisional~     tissues while under general anesthesia. Total post-operative opioid consumption expressed in~     morphine equivalent dose will be recorded, including IV and oral opioids. Time in hours from~     operation conclusion to discharge and discharge disposition (to where the patient is~     discharged) will also be recorded. Post-operative pain scores will be assessed and recorded~     in the immediate post-operative period and every 4 hours subsequently until the patient is~     discharged. Medication related side effects will be monitored. The investigators hypothesize~     that the injection cohort will have reduced pain scores, lower narcotic requirements, shorter~     length of stay, and be more likely to discharge to home following surgery.~   "
45817|NCT02967159|"~     AZD7594 is a non steroidal, potent and selective modulator of the glucocorticoid receptor~     (GR) under development for once daily inhaled treatment of chronic obstructive pulmonary~     disease (COPD) and asthma. Abediterol is a novel and selective β2 adrenergic receptor agonist~     with the potential for once daily treatment of asthma and COPD in fixed dose combination~     (FDC) with an ICS or a novel anti inflammatory (AI) agent. This study will be the first~     clinical study for the combination exposure of AZD7594 with abediterol as 2 compounds in FDC~     or in free combination via 2 separate dry powder inhalers (DPIs). This study will be~     conducted in healthy male subjects to minimize the effects of concomitant disease states or~     medications on study measurements.~   "
45818|NCT02967146|"~     Anti-adhesive effect and Safety of a mixed solid of poloxamer, gelatin and~     chitosan(Mediclore®) after axillary dissection for breast cancer~   "
45819|NCT02967133|"~     The optimal prioritization of second-line chemotherapy and immune therapy based on~     demographic or biomarker data is an area of ongoing investigation. The hypothesis of this~     study is that there may be an additive or synergistic antitumor effect of combined~     chemotherapy and nivolumab in the second-line treatment of NSCLC as an important concept to~     test in a clinical trial. Previously treated NSCLC remains a setting of unmet clinical need~     despite recent clinical research progress. Early progression for a subset of NSCLC patients~     receiving nivolumab is a specific area of clinical need.~   "
45820|NCT02967120|"~     The purpose of this study is to verify the function of p16 hydroxymethylation diagnostic~     reagents in early diagnosis of oral cancer.~   "
45821|NCT02967107|"~     Comparing the efficacy of cold snare polypectomy with endoscopic mucosal resection~   "
45822|NCT02967094|"~     Study was designed to evaluate efficacy of mucolytic solution ingested before upper endoscopy~     on visibility of gastric mucosa.~   "
45823|NCT02967081|"~     The purpose of this study is to determine whether dentinal fluid (tooth fluid) of teeth with~     or without a painful inflammatory condition in their nerve (pulp) contain inflammatory~     marker.~   "
45824|NCT02967068|"~     The purpose of this study is to collect existing tissue specimens from subjects enrolled in~     Vasculitis Clinical Research Consortium (VCRC) studies. Analysis of these tissue specimens~     and linked clinical data collected through VCRC studies may lead to the identification and~     development of a series of translational research projects. Results of these studies will~     provide vasculitis researchers with insight into the causes of these diseases and generate~     new ideas for diagnostic tests and therapies, and will be of great interest to the larger~     communities of researchers investigating vasculitis and other autoimmune, inflammatory, and~     vascular diseases.~   "
45825|NCT02967055|"~     This exploratory study will fill a knowledge gap regarding the pharmacokinetic effects of~     isotretinoin on the etonogestrel (ENG) contraceptive implant.~   "
45826|NCT02967042|"~     Chronic kidney disease (CKD) is an increasing public health problem and the number of patient~     with chronic kidney disease is increasing worldwide. Bone abnormalities are found almost~     universally in patients with CKD requiring dialysis and in the majority of patients with CKD~     stages 3-5. Chronic kidney disease-mineral bone disorder (CKD-MBD) is a complex disorder of~     bone and mineral metabolism, which is associated with disorder in circulating levels of~     hormones and development of secondary hyperparathyroid disease. The abnormalities of mineral~     homeostasis impair bone remodeling and mineralization and results in cortical and trabecular~     defects and an increased fracture risk. There is also an association with increased morbidity~     and mortality. CKD-MBD is also associated with development of calcification of the blood~     vessels. During the last decade it has been increasingly acknowledged that mineral and bone~     disorder contribute to the excessively high cardiovascular morbidity and mortality in~     patients with chronic kidney disease. The pathophysiology behind the disorder varies a lot~     and can be divided into three groups; high turnover renal bone disease, low-turnover disease~     and mixed-uremic osteodystrophy. The treatment of CKD-MBD depends of the subtype of the~     disorder.~      The diagnosis of CKD-MBD is still challenging. Biomarkers such as parathyroid hormone (PTH)~     and alkaline phosphatase (ALP) are used to evaluate bone turnover and formation, but both~     biomarkers have several limitations and are both unspecific. Many biomarkers have been used~     in research applications, but yet none of them is in clinical use. Dual X ray absorptiometry~     (DXA) is used to measure fracture risk in patients with normal kidney function, but is not~     useful in patients with chronic kidney disease stage 3 - 5. Different imaging techniques have~     been investigated, but still bone biopsy is the golden standard for diagnosing and~     classification of the subtypes of CKD-MBD. Bone biopsy is invasive and is not available in~     every center.~      This study`s goal is to evaluate, if 18-Fluor-Positron emission tomography-computed~     tomography (18F-PET-TT) can be used in the assessment of CKD patients. The hypothesis is that~     18-PET-TT correlates with the histomorphometry of bone biopsy and with the calcification~     score in CKD patients and that 18F-PET-TT maybe can be used as a diagnostic imaging technique~     in the future.~   "
45834|NCT02966925|"~     Vulvovaginal irritation is a frequent complaint among postmenopausal women. Common symptoms~     of vaginal atrophy include dryness, itching, burning and dyspareunia.~      This pilot study will assess the efficacy of platelet-rich plasma (PRP) combined to~     hyaluronic acid (HA) to relieve vulvovaginal dryness in patients who cannot benefit from~     reference treatments (hormonal therapies).To achieve this, 20 patients suffering from~     vulvovaginal dryness will be treated with one session of injections in the vulva, the~     posterior vaginal wall and the perineum, and followed-up for 6 months. Improvement of vaginal~     dryness will be primarily appreciated through Friedmann score and pH value, and secondarily~     through the Female Sexual Function Index (FSFI), as measured at baseline and 1, 3 and 6~     months after the treatment.~   "
46148|NCT02962830|"~     The fetus may be exposed during pregnancy to nociceptive stimuli because of fetal pathology~     (e.g., malformation) or a diagnostic or therapeutic procedure.~      To date, there is very little data and no consensus on fetal analgesia. The aim of the~     investigators study is to evaluate the pharmacokinetics of Sufentanil after intra amniotic~     injection.~   "
45827|NCT02967029|"~     For a successful functional endoscopic sinus surgery (FESS), it is crucial to provide~     effective controlled hypotension to reduce blood loss and provide a relatively blood-free~     surgical environment to facilitate surgery.~      The goal of controlled hypotension is to maintain an arterial blood pressure which is~     sufficiently low to allow a reduction in bleeding with offering a superior intraoperative~     hemodynamic stability during stressful surgical events to maintain intact cerebral~     microcirculatory auto-regulation.~      Auto-regulation impairment during controlled hypotension might increase oxygen extraction~     ratio. Thus monitoring the cerebral oxygen saturation (rSO2) to measure cerebral oxygenation~     becomes essential and it remains a challenge to clinically assess cerebral oxygenation on a~     routine basis.~      Various recent studies reported based on facilitating the induction of controlled~     hypotension, but the effects of hypotension on cerebral perfusion and oxygenation and its~     effects on postoperative cognitive function are still poorly characterized. Moreover, the~     relationship between rSO2 and controlled hypotension has not been established in patients~     undergoing FESS.~      Within the last decade, near infrared spectroscopy (NIRS) INVOS® monitors which is clinically~     most broadly spread technique, can be used for non-invasive assessment of cerebral perfusion~     by detecting changes in rSO2 by online monitoring of cerebral oxygenation.~      In our clinical routine for achieving a controlled hypotension, esmolol and remifentanyl are~     the most commonly used hypotensive agents. The aim of this prospective randomized single~     blind study was to investigate the influence of remifentanyl as a hypotensive agent in~     comparison to esmolol on rSO2 by using NIRS and postoperative cognitive function in patients~     undergoing FESS.~   "
45828|NCT02967016|"~     To the best of the investigators knowledge the average level of physical activity (PA) of~     parturients recovering from a cesarean delivery or after a normal spontaneous vaginal~     delivery (NSVD) remains unknown. Taking in consideration that parturients are in a~     hypercoagulable state and that obstetric venous thromboembolism (VT) is one of the most~     common causes of maternal morbidity and mortality, ambulation is of utmost importance to~     anesthesiologists as well as obstetricians. In order to promote mobility, first the~     investigators need to learn the average parturients level of physical activity in the~     immediate post-partum period and up to 48 hours after delivery. This information may help us~     promote mobility in the immediate postpartum period, particularly for those that underwent a~     cesarean delivery since they are at higher risk of VT.~   "
45829|NCT02966990|"~     The orthotics are auxiliary therapeutic resources indicated for the relief of pain, improves~     functional standard or correction of deformities. There is a lack of studies that analyze the~     biomechanical changes promoted by the Orthotics in functional pattern of the upper limb. The~     objective of this proposal is to analyse biomechanical changes in the functional upper limb~     pattern with the use of orthoses for patients with dysfunctions arising from musculoskeletal~     system trauma or burns, aiming to contribute with scientific evidence to clinical practice.~     The project will analyze the changes in the pattern of the upper limb functional through the~     use of dynamic and static Orthotics by means of kinematic and electromyographic analysis~     while conducting a functional task. These comparisons will be carried out with and without~     the use of functional Orthotics, and the controls are the patients themselves. Methods: 25~     patients will be included over 18 years with malfunctions resulting from orthopaedic trauma~     and Burns of the upper limb with indication and Orthotics for improving functional pattern.~     For characterization of the sample will be performed: esthesiometric , hand and the~     (Disabilities of the Arm, Shoulder and Hand) DASH Questionnaire. Biomechanical assessment~     will be used for the analysis and electromyographic kinematics. For statistical analysis will~     be applied the method of analysis of variance (ANOVA) for repeated measures, and when~     necessary, the post hoc Bonferroni test. Will be adopted as significance level p ≤ 0.05.~   "
45830|NCT02966977|"~     The aim of this study is to evaluate the effect of an extension of conventional urine~     diagnostics with mass spectrometry in patients with a suspected UTI. Mass spectrometry is~     done directly from the urine sample (without an intermediate bacterial culture).The primary~     outcome is the time from the entry of a urine sample in the microbiological laboratory to the~     adequate/optimal/definitive treatment. Secondary outcomes are the time to diagnosis of a~     therapy relevant UTI, the quantity of antibiotics prescribed per patient and ward and a~     comparison of the length of hospital stay.~   "
45831|NCT02966964|"~     The patient who meets the inclusion/exclusion criteria is assigned to Test1 group or Test 2~     group or control group randomly.~      All subjects take one pill of Viread® Tab. (Tenofovir Disoproxil Fumarate 300mg) once a day~     for 48 weeks. At the same time, all randomized subjects take two pills of DWPUR001 or Placebo~     of DWPUR001 twice a day for 48 weeks.~   "
45832|NCT02966951|"~     Adipose tissue derived Mesenchymal Stem cells (ATMSC) will be injected in patients diagnosed~     with Knee osteoarthrosis~   "
45833|NCT02966938|"~     Food allergies are constantly increasing. Peanut and nut allergies are a major cause of~     allergic reactions. Diagnosed patients are also at risk, because 27% of the patients that had~     an allergic reaction have another one in the following year with the same food, despite a~     real improvement in industrial products labeling.~      The investigators have observed in the allergy Unit that patients (and/or their family)~     following an elimination diet, sometimes since several years, use very strict elimination~     strategies. Those strategies sometimes lead to incapacities to recognize the allergens. Yet,~     a good identification of the allergen is the key to a successful elimination and the~     non-identification a known risk factor.~      Ferdman shown in 2006 that 27% of the patients didn't recognize the allergen there were~     allergic to. However, this is a US study, and geographical specificities have an impact on~     food consumption and culture. Food allergology needs to take those two elements into account.~     For example, in France, a single food can have two names. It is the case of peanut, which can~     be called arachide, or more frequently cacahuète.~      The goal of the study is to observe patient aptitudes to recognize peanut (and the~     association between the two names) and other nuts available in France and define by the~     European law, using a plate with various food samples in seed or in shell.~      Thus, patients in care at the allergy Unit of Saint Vincent Hospital of Lille (France) and~     their families were surveyed with a standardized procedure at the beginning of their~     therapeutic education and their capacity to recognize various nuts, to identify peanut~     (cacahuète or arachide) and to associate the two words cacahuète and arachide was~     assessed. It is a standard procedure in therapeutic education, and the responses have been~     systematically entered in the medical record.~      The main objective of this study is to describe peanut or nut allergic patient capacity~     (adult, children and/or the family) to visually identify the foods there are allergic to.~      The secondary objective of this study is to describe the capacity of patient that describe~     themselves as allergic to arachide to associate this word to the word cacahuète.~   "
45835|NCT02966912|"~     The objective of this study is to investigate whether nutritional supplementation with~     magnesium can improve cardiovascular structure and function in participants with obesity -~     with a long-term goal of preventing clinical heart failure. Specifically, in a randomized~     open-label pilot study, we will assess whether dietary Magnesium (Mg) supplementation (versus~     no supplementation) for 24 weeks in obese patients will improve left ventricular (LV) mass.~   "
45837|NCT02966886|"~     The primary objective of this study is to determine the difference in disease specific~     quality of life outcome measures between patients diagnosed with osteoarthritis of the~     shoulder joint whom require a total shoulder replacement between the following study arms:~     1)TSA using an augmented component compared with TSA using a standard component with~     eccentric reaming in patients 65 years of age or younger or 2) TSA using an augmented~     component or reverse shoulder arthroplasty in patients older than 65 years of age as measured~     by the Western Ontario Osteoarthritis of the Shoulder Index (WOOS) score at post-operative~     time intervals (ie. 3, 6, 12 and 24 months).~      The secondary objective is to determine the difference in disease specific quality of life~     between treatment allocations in both age groups as measured by the Constant score, the~     American Shoulder and Elbow Surgeons Standardized Shoulder Assessment form (ASES) and the~     EuroQol Group EQ-5D-5L score at post-operative time intervals (ie. 3, 6, 12 and 24 months).~      A secondary objective will be to determine the survivorship of the components as measured by~     the degree of radiographic lucencies and component alignment determined by a CT scan at 1 and~     5 years post-surgery between study allocations in both age groups.~   "
45838|NCT02966873|"~     This is a randomized controlled Phase II clinical trial designed to evaluate the effects of~     N-acetylcysteine (NAC) in reducing Alcohol Use Disorder (AUD) severity and Post Traumatic~     Stress Disorder (PTSD) symptomatology among individuals with current AUD and PTSD.~   "
45839|NCT02966860|"~     A single-dose study evaluating the oral PK of an oxycodone/apap solution in healthy subjects~     under fasted conditions~   "
45840|NCT02966847|"~     In the coming years, an increase in lung nodule resection is expected, particularly in~     Video-assisted thoracoscopic surgery (VATS). In some situations, it is necessary to use a~     device for locating these nodules. Meanwhile, the Cone Beam Computed Tomography (CBCT) is a~     tool whose use is constantly spreading.~   "
45841|NCT02966834|"~     This study is being conducted to evaluate the efficacy, safety and tolerability of GSK2330672~     administration for the treatment of pruritus (itch) in participants with primary biliary~     cholangitis (PBC). Participants will be treated with either placebo or one of the 4 dose~     regimens of GSK2330672 (20 milligram [mg], 90 mg or 180 mg taken once daily or 90 mg twice~     daily). Subjects on GSK2330672 will also receive placebo tablets to maintain blinding. The~     total duration of a subject's participation will be up to 45 days of screening and 24 weeks~     of study including follow-up.~   "
45842|NCT02966821|"~     A phase II, single-arm, open-label, multicenter study to assess the efficacy and safety of~     sulfatinib as a second-line treatment in patients with surgically unresectable or metastatic~     biliary tract carcinoma~   "
45843|NCT02966808|"~     Mobility problems in multiple sclerosis (MS) is a frequent symptom. It might appear in almost~     93% of patients in the first 15 years of the disease, being a clear problem for their normal~     living. Nevertheless, therapeutic options for this symptom are few and optimal for only some~     patients.~   "
45844|NCT02966795|"~     A Phase 3b, open-label, multicenter study to evaluate the efficacy and safety of glecaprevir~     (ABT-493)/pibrentasvir (ABT-530) for an 8- or 12-week treatment duration in participants with~     chronic Hepatitis C Virus (HCV) genotype (GT) 5 or 6 infection, with or without compensated~     cirrhosis, who are either HCV treatment-naïve or treatment experienced with interferon (IFN)~     or pegylated interferon (pegIFN) with or without ribavirin (RBV) (defined as P/R~     treatment-experienced) or sofosbuvir (SOF) plus RBV with or without pegIFN (defined as SOF~     plus RBV treatment-experienced).~   "
45845|NCT02966782|"~     This is a Phase 1b, dose-ranging, open-label, multicenter study designed to evaluate the~     safety and pharmacokinetics of venetoclax as a single-agent and in combination with~     azacitidine in participants with higher-risk Myelodysplastic Syndromes (MDS) after~     Hypomethylating Agent (HMA)-Failure.~   "
45846|NCT02966769|"~     The objective of this multicenter retrospective study is to compare overall survival in~     patients with stage IIIA-N2 NSCLC treated with neoadjuvant treatment and surgery versus~     definitive chemoradiation.~      Secondary objectives are to analyze disease-free survival, median survival, locoregional and~     distant relapses as well as mortality and toxicity related to treatment.~   "
45847|NCT02966756|"~     This is a Phase 2, open-label, single-arm, multicenter study, evaluating the efficacy of~     venetoclax in participants with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) in~     the presence of 17p deletion.~   "
45848|NCT02966743|"~     Compare the changes of regional cerebral oxygen saturation during midazolam or~     dexmedetomidine sedation for spinal anesthesia in the elderly patients who undergoing femur~     surgery.~   "
45849|NCT02966730|"~     The purpose of this study is to find out how successful ibrutinib is at putting follicular~     lymphoma into full remission. In this study, remission will be determined by achieving a~     normal PET scan after treatment. A PET scan is an imaging test that looks for active~     lymphoma. People who don't have a complete remission on PET after their first treatment are~     at high risk for having their lymphoma return. This study will investigate if ibrutinib will~     help participants achieve a complete remission without giving additional chemotherapy. The~     study will also investigate any possible side effects of the study drug ibrutinib.~   "
45850|NCT02966717|"~     Primary nephrotic syndrome(PNS) is a group of clinical symptoms caused by a variety of~     factors, including immune,environmental, genetic, et al. Oral corticosteroids have been to be~     the preferred drug for the treatment of PNS, but the long-term use of glucocorticoid therapy~     in clinic often induces some problems such as hormone dependent and hormone resistance, as~     well as severe side effects which act as a threat to the patients' health. Besides, patients~     with proteinuria long-term not control often behave faster progression into chronic renal~     failure, leading to poor prognosis. In renal diseases, Rituximab ( RTX) is often used in the~     treatment of refractory nephropathy, such as hormone dependent nephrotic syndrome, hormone~     resistance nephrotic syndrome, frequency recurrence nephrotic syndrome, which shows exciting~     effects in delaying the development of the disease.At present, mesenchymal stem cells ( MSCs)~     has been used as a research hotspot to repair the tissue damage of chronic kidney disease,~     and it also behaves certain effects. The purpose of this study is to seek a more targeted~     treatment, more precise curative effect and more feasibility treatment for PNS(CKD3-4),so as~     to delay or reverse the disease and improve the quality of life of patients with CKD.~   "
46160|NCT02962674|"~     The purpose of this study is to evaluate the safety and performance of the ProstaCare System~     in relieving symptoms of urinary outflow obstruction secondary to benign prostatic~     hyperplasia.~   "
45851|NCT02966704|"~     The evaluation of protein quality has been identified as the top priority question by the~     Food and Agricultural Organization (FAO) of the United Nations. However, the current~     available methods do not precisely estimate protein quality, or need invasive procedures. The~     proposed 'dual tracer approach' is a non-invasive method to evaluate protein quality in~     humans.~      The present project characterizes the use of 15N-intrinsically-labelled milk protein as a~     reference-protein for development a non-invasive method that can be used to assess protein~     quality in human subjects~   "
45852|NCT02966691|"~     This clinical study is designed to evaluate the diagnostic performance of VisioCyt test,~     which would improve the early diagnosis of bladder cancer in order to optimize the management~     of individual patients as part of a cancer diagnostic monitoring. The diagnostic method of~     VisioCyt® device is based on the analysis by transmission and fluorescence, of urinary~     cytology slides prepared according to the protocol VisioCyt.~   "
45853|NCT02966678|"~     Incidence of dyschromatopsia~   "
45854|NCT02966665|"~     Many control mechanisms exist which successfully match the supply of blood with the metabolic~     demand of various tissues under wide-ranging conditions. One primary regulator of vasomotion~     and thus perfusion to the muscle tissue is the host of chemical factors originating from the~     vascular endothelium and the muscle tissue, which collectively sets the level of vascular~     tone. With advancing age and in many disease states, deleterious adaptations in the~     production and sensitivity of these vasodilator and vasoconstrictor substances may be~     observed, leading to a reduction in skeletal muscle blood flow and compromised perfusion to~     the muscle tissue. Adequate perfusion is particularly important during exercise to meet the~     increased metabolic demand of the exercising tissue, and thus any condition that reduces~     tissue perfusion may limit the capacity for physical activity. As it is now well established~     that regular physical activity is a key component in maintaining cardiovascular health with~     advancing age, there is a clear need for further studies in populations where vascular~     dysfunction is compromised, with the goal of identifying the mechanisms responsible for the~     dysfunction and exploring whether these maladaptations may be remediable. Thus, to better~     understand the etiology of these vascular adaptations in health and disease, the current~     proposal is designed to study changes in vascular function with advancing age, and also~     examine peripheral vascular changes in patients suffering from chronic obstructive pulmonary~     disease (COPD), Sepsis, Pulmonary Hypertension, and cardiovascular disease. While there are~     clearly a host of vasoactive substances which collectively act to govern vasoconstriction~     both at rest and during exercise, four specific pathways that may be implicated have been~     identified in these populations: Angiotensin-II (ANG-II), Endothelin-1 (ET-1), Nitric Oxide~     (NO), and oxidative stress.~   "
45855|NCT02966652|"~     DITEST is an oral formulation of native testosterone for the treatment of androgen deficiency~     in men. The proposed study is a Phase 1 clinical study in hypogonadal men, defined according~     to FDA and Endocrine Society Guidelines, designed to evaluate the pharmacokinetic (PK)~     characteristics of DITEST, and to assess the safety and tolerability of DITEST in the target~     population.~   "
45856|NCT02966639|"~     The main objective of this study is the external validation of the appropriateness criteria~     for the surgical treatment of Lumbar Degenerative Spondylolisthesis. We will assess,~     prospectively, whether patients treated appropriately have better outcomes than those~     treated inappropriately according to the RAND Appropriateness Method (RAM) Criteria.~   "
45857|NCT02966626|"~     Type 2 diabetes is creating a health pandemic globally. Management of type 2 diabetes~     involves combination of lifestyle intervention and drug intervention, which includes~     sodium-glucose transporter 2 (SGLT-2) inhibitors, such as dapagliflozin. Dapagliflozin~     (Forxiga®) was approved by the Malaysian Drug Authority for the treatment of type 2 diabetes~     in 2014. This study will describe the characteristics of patients who are prescribed~     dapagliflozin by diabetologists/endocrinologists in a tertiary referral center and describe~     their glycaemic control, weight, and renal function at baseline and during use of~     dapagliflozin.~   "
45858|NCT02966613|"~     To evaluate the lower limb alignment following total knee arthroplasty (TKA) performed with~     fully disposable patient-specific instrumentation versus conventional, versus patient~     specific instrumentation.~   "
45859|NCT02966600|"~     The aim of this randomized controlled trial was to assess the impact of progressive~     resistance exercise (PRE) in PD patients with akinesia and rigidity (AR-subtype). The~     investigators hypothesized the intervention would have a beneficial effect on the study~     outcomes.~   "
45860|NCT02966587|"~     This phase II trial studies how well durvalumab works in treating patients with prostate~     cancer that is resistant to hormones and has spread to other places in the body. Monoclonal~     antibodies, such as durvalumab, may interfere with the ability of tumor cells to grow and~     spread.~   "
45861|NCT02966574|"~     Whole-body MRI including diffusion is a booming technique. Numerous studies have demonstrated~     its interest in metastatic cancers. Breast cancers, especially hormone-sensitive ones, are~     very osteophilic and bones are the most frequent metastatic site.~      Apart from morphological criteria (lesion size and RECIST criteria), MRI provides~     quantitative functional criteria (diffusion and ADC values). According to a recent study,~     whole body MRI is as good as PET/CT and more effective than bone scintigraphy for the~     diagnosis of bone metastases for cancers of breast and prostate with a high metastatic risk.~      Therefore, it seems appropriate to study the performance of whole body MRI in the~     pre-therapeutic assessment of breast cancer with a high risk for metastasis and the~     monitoring of metastatic breast cancer.~   "
45862|NCT02966561|"~     The STAR-study (STay Active after Rehabilitation) investigates in a randomized controlled~     trial (RCT) the additional effect of a pedometer-based behavior change intervention (BCI)~     during in-patient pulmonary rehabilitation (PR) on objectively measured physical activity~     (PA) 6-weeks and 6-months post PR. The BCI uses the behaviour change techniques a)~     instruction on how, where and when to perform the behavior, b) prompt goal setting for~     physical activity, c) prompt self-monitoring of behavior and d) feedback on behavior. The~     primary outcome of PA will be measured using an accelerometer (Actigraph wGT3X) for a time~     period of seven days, firstly two weeks before rehabilitation begins (T0 = study phase I) as~     well as six weeks and six months (T3 and T4) after PR. Additionally to predict PA progression~     after PR, a complex personal diagnostic, including questionnaires as well as functional~     assessments, is to be carried out at the start (T1 = start of study phase II) and end of PR~     (T2). This diagnostic is based on the main ideas of the PA-related health competence model~     (PARC-model) and especially incorporates physical and psychological personal determinants of~     PA.~   "
45863|NCT02966548|"~     This study will be used to determine the safety and tolerability of BMS-986016 administered~     alone and in combination with Nivolumab in subjects with advanced solid tumors.~   "
46205|NCT02962076|"~     Imaging is to be performed prior to procedure using positron emission tomography/ computed~     tomography (PET/CT), after a special dye is injected. The scans are going to be merged with~     other cardiac scans when doing the ablation procedure to correlate anatomy with physiology.~   "
45864|NCT02966535|"~     Gas exchange disturbance frequently occurs in steep Trendelenburg position during~     robot-assisted laparoscopic prostatectomy or cystectomy. Due to increased intrathoracic~     pressure and absorbed carbon dioxide (CO2) gas insufflated into abdominal cavity, hypercapnia~     as well as hypoxia may occur. Inverse ratio ventilation or prolonged inspiratory time during~     mechanical ventilation has been reported to be improve gas exchange in adult respiratory~     distress syndrome. The investigators attempt to test the hypothesis that prolonged~     inspiratory time may improve the gas exchange during robot-assisted laparoscopic urologic~     surgery.~   "
45865|NCT02966522|"~     To prove the organ-reversing potential of thalidomide for amyloidosis with cardiac~     involvement~   "
45866|NCT02966509|"~     The Engagement of Patients with Advanced Cancer is an intervention that utilizes well-trained~     lay health coaches to engage patients and their families in goals of care and shared~     decision-making after a diagnosis of advanced cancer. Although lay health workers have never~     been tested in this role, we hypothesize that lay health workers can feasibly improve goals~     of care documentation and help to reduce unwanted healthcare utilization at the end of life~     for Veterans diagnosed with new advanced stages of cancer and those diagnosed with recurrent~     disease.~   "
45867|NCT02966496|"~     This trial is designed to compare the biocompatibility and long-term visual outcomes of the~     Tecnis Z9001 and Acri.LISA 366D multifocal IOLs used for the treatment of senile cataract.~     The aim is to provide a safer biomaterial for senile cataract treatment, achieving better~     postoperative visual quality and fewer complications.~   "
45868|NCT02966483|"~     Laparoscopic surgery for rectal cancer has been successfully proven to be a non-inferior~     alternative regarding resection quality, and oncological outcomes of patients as compared to~     open surgery in mangy clinical trails. Moreover, laparoscopic surgery is advantageous over~     open surgery with regard to operative invasiveness, patient's recovery, and wound related~     complications. Thus, laparoscopic surgery has gained great popularity over the past decades.~     However, specifically for mid and low rectal cancer, laparoscopic surgery is technically~     demanding, which sometimes leads to high morbidity and unsatisfactory resection quality,~     especially in challenging cases such as bulky mesorectum, enlarged prostate, irradiated~     pelvis, etc. Under this circumstance, transanal total mesorectal excision (TaTME) , the so~     called down-to-up alternative, has emerged as a promising solution to these problems in~     recent years and more and more small studies have proven the feasibility and advantages of~     this technique, making it become a hot topic among both literature and conferences. However,~     TaTME is still at early birth, higher-level evidences, either multicentric, or comparative~     study with conventional surgery is strikingly lacking. Thus the investigators conduct this~     multicentre randomised clinical trial, comparing transanal TME versus laparoscopic TME for~     mid and low rectal cancer, aiming to prove the hypothesis that TaTME may achieve better~     resection quality and result in non-inferior oncological outcome, as well as short term~     operative morbidity and mortality.~   "
45869|NCT02966470|"~     This study aims to assess if grip strength can be used as a single, objective surrogate of~     frailty assessment in the surgical population.~   "
45870|NCT02966457|"~     MDR (multidrug resistant) gram-negative bacteria have emerged as an important cause of~     bloodstream infection in hospitalized patients, especially in immunocompromised hosts. It was~     previously shown, that intestinal colonization with extended-spectrum β-lactamases~     (ESBL)-producing or carbapenem-resistant Enterobacteriaceae, carbapenem-resistant A.~     baumannii and P. aeruginosa) is a clinical predictor of bloodstream infections in patients~     with haematological malignancies and/or haematopoietic stem cell transplantation [Stoma I. et~     al., 2016].~      To the investigators knowledge no randomized, placebo-controlled clinical trial has been~     performed to study the efficacy and safety of selective intestinal decolonization strategies~     in high-risk patients with haematological malignancies. Possible decolonization of MDR~     gram-negative bacteria in haematological patients could be important for the patient by~     reducing the risk of infection and for the community by reducing the risk of transmission.~      The purpose of the proposed study is to assess the efficacy and safety of selective~     intestinal decolonization of MDR gram-negative bacteria with oral administration of~     Colistimethate sodium in high risk patients with haematological malignancies.~   "
45871|NCT02966444|"~     This study evaluates the effects of dietary fatty acid composition from high fat meals on~     markers of hunger, satiety and metabolism.~   "
45872|NCT02966431|"~     Determine the effects of an 8-week weight loss intervention.~   "
45873|NCT02966418|"~     The purpose of this study is to study the effects of intermittent whole-body hypoxic~     preconditioning on patients with carotid artery stenosis.~   "
45874|NCT02966405|"~     A descriptive analysis involving 300 healthy pregnant women to the establish of~     trimester-specific reference ranges for thyroid tests in pregnant women. 700 cases were~     selected as the normal pregnant population to establish a self-sequential longitudinal~     reference range.~   "
45875|NCT02966392|"~     The purpose of the study is to determine whether automated cuff pressure control results in a~     reduction in the proportion of patients developing ventilator associated respiratory~     infections during their stay in intensive care.~   "
45876|NCT02966379|"~     Some candidates to cochlear implantation can have residual low frequencies hearing. The EVO~     electrode lead has been specifically designed to preserve this residual hearing through~     surgery. It is then possible to provide the patient with a electro-acoustic stimulation (EAS)~     which combines both an acoustical stimulation for the preserved low frequency hearing and an~     electrical stimulation through the cochlear implant. The major aim of this study is to~     evaluate hearing preservation after implantation with the EVO electrode lead.~      The secondary outcome is to evaluate the benefit of EAS stimulation provided by the Zebra~     speech processor.~   "
45877|NCT02966366|"~     Recent studies have reported successful reduction of tinnitus after cochlear implantation~     (CI) in most CI users, but the mechanisms of reduction and the amount of improvement is not~     fully understood. Especially, the relative role of peripheral and central auditory pathways~     is not clearly known. This study assessed the effect of CI electrical stimulation on tinnitus~     in subjects with unilateral tinnitus related to a single-sided deafness (SSD), and relative~     contributions of peripheral and central auditory pathways in tinnitus reduction.~   "
45878|NCT02966353|"~     This is a study of treatment with ruxolitinib in patients who present with transfusion~     dependent or independent anemia with 10 mg BID starting dose and subsequent up titrations~     depending on safety and efficacy.~   "
45880|NCT02966327|"~     Objectives: 1) To evaluate the effect of early compression therapy with individualized~     exercise on the incidence of lower limb lymphedema at 12 months post-operatively in patients~     treated for gynecological cancer who are at risk of developing lymphedema; 2) To evaluate the~     effect of early compression therapy with individualized exercise on lower limb volume,~     quality of life and incidence of cellulitis infections at 12 months post-operatively in this~     population.~   "
45881|NCT02966314|"~     The overall hospitalizations for a diagnosis of angioedema doubled from the year 2000 to~     2009. Although some of the cases represented hereditary angioedema or ace-inhibitor induced~     angioedema, the majority of episodes were idiopathic. Idiopathic Angioedema (IAE) can be~     life- threatening especially when affecting tissues within the respiratory tract. No clear~     guidelines exist for management of this important condition for clinicians. Current therapies~     typically include avoidance of potential triggers and use of medications either for~     prophylaxis or for acute events, such as antihistamines, corticosteroids, and epinephrine.~     There remains a critical need for therapeutic options to provide more effective prophylaxis.~   "
45882|NCT02966301|"~     This study aims to evaluate the early chronic GvHD events (first line therapy), if the~     addition of arsenic trioxide to standard therapy with corticosteroids, with or without~     cyclosporine, will be effective in controlling chronic GvHD and to reduce the duration of~     corticosteroid therapy~   "
45883|NCT02966288|"~     The study objective is to determine whether a single intra-articular dose of an~     anti-inflammatory (Toradol) will reduce the need for other analgesic medications and, if so,~     how long the benefits will last.~   "
45884|NCT02966275|"~     This study is to test our automated hypoglycemia prevention and treatment device~     (glucagon-only bionic pancreas) in subjects that have undergone post-bariatric surgery that~     are experiencing symptoms of hypoglycemia.~   "
45885|NCT02966262|"~     All comer registry who had undergone intravascular optical coherence tomography during and/or~     after coronary intervention.~   "
45886|NCT02966249|"~     The present study is designed to evaluate and compare the efficacy of intrathecal~     dexmedetomidine (DEX) as an adjuvant to Levobupivacaine in spinal anaesthesia and DEX's~     intravenous administration, without loading dose, additionally to spinal anaesthesia, in~     patients undergoing total knee arthroplasty.~   "
45887|NCT02966236|"~     This study is a double blinded randomized controlled trial evaluating the impact of~     tranexamic acid use on the transfusion rate in patients with complex kidney stones undergoing~     percutaneous nephrolithotomy.~   "
45888|NCT02966223|"~     The primary question of interest is quantifying the relationship between Y-90 liver therapy~     and liver damage. Little is known on this subject. Present assumptions and calculations of~     Y-90 administration are based on surgical lobar hepatectomies and external radiation beam~     therapies. The investigators hope that by using a functional model of the liver, the~     investigators can improve this important knowledge gap.~      The investigators will be enrolling patients planning to receive Y-90 therapy for the~     treatment of liver malignancies. The diagnosis of a primary liver cancer, hepatocellular~     carcinoma (HCC), is usually made by a combination of specific imaging findings and clinical~     criteria; only rarely is a confirmatory biopsy performed. This is due to the high accuracy of~     the present diagnostic model and the significant risk of biopsy and tumor seeding.~      Y-90 therapy involves administering radioactive particles to liver tumors by placing a~     catheter in a hepatic artery supplying the tumor using angiographic techniques and injection~     of these particles.~      Y-90 Positron Emission Tomography-Computed Tomography (PET/CT) imaging has been established~     as a method to validate and quantitate distribution of Yttrium after Y-90 administration. The~     post Y-90 therapy PET/CT images provide an imaging distribution of the Y-90, which is~     essential for validation of administered versus planned dose to the liver lesion and~     background liver.~      If the investigators can compare the Y-90 distribution to estimate background liver radiation~     distribution and dose (generated by the Y-90 PET/CT scan) combined with the global and~     regional function map (generated by the hepatobiliary [HIDA] scan performed before and after~     therapy), then the investigators will be assuming that the difference pre and post therapy in~     global and regional function can be ascribed to the Y-90 administration. The investigators~     will also analyze the Magnetic Resonance Imaging (MRI) and CT sets performed before and after~     therapy and correlate the imaging results collected with clinical findings such as~     ascites/encephalopathy and routine serological markers (bilirubin, albumin, International~     normalized ratio [INR], etc.). With this information, the investigators will have the~     potential to establish whether there is a relationship between Y-90 distribution to~     non-tumoral (normal) hepatic parenchyma and the incidence and severity of~     Radioembolization-Induced Liver Disease (REILD). This would have the potential to improve~     selection criteria and outcomes in populations selected for Y-90 therapy in the future.~   "
45889|NCT02966197|"~     Placenta previa and accreta both could potentially cause serious postpartum hemorrhage and~     even maternal death. Interventional radiological techniques have been developed to limit~     massive hemorrhage during caesarean section. This study investigated the efficacy of~     prophylactic internal iliac artery balloon catheterization in management for placenta previa~     and accreta.~   "
45890|NCT02966184|"~     This study is designed to compare the length of continuous albuterol administration between~     two different albuterol formulations, BAC containing albuterol versus preservative free~     albuterol.~   "
45891|NCT02966171|"~     This is a first-time-in-human, phase I, open-label, dose-escalation study of HMPL-453 in~     patients with advanced or metastatic solid malignancies who have failed or are intolerable to~     standard therapies or for whom no standard therapies exist. There are preliminary two stages~     in this study: a dose-escalation stage (stage 1) and a dose-expansion stage (stage 2). We~     will decide whether to conduct stage 2 or not one month after the last patient included in~     stage 1.~   "
45892|NCT02966158|"~     Heart disease is the number one killer amongst chronic diseases around the world, and it is~     responsible for taking the lives of an estimated 17.5 million people each year.~     Exercise-based cardiac rehabilitation (CR) programs, which help heart patients improve their~     current health, prevent future heart problems, and improve their quality of life, are an~     effective strategy for lowering the risk of heart-related deaths in heart patients. CR~     programs currently have their patients perform moderate intensity, continuous exercise~     (MICE), which traditionally takes the form of walking, jogging, or cycling at a comfortable~     pace for 30-60 minutes. Recently, aerobic interval training (AIT), which involves performing~     short bouts of exercise, typically ranging from 15 seconds to four minutes at near maximal~     effort, followed by periods of recovery or rest, has emerged as a more effective strategy~     than MICE for lowering the risk of heart-related deaths in heart patients. Although these~     initial findings appear to hold much promise for improving CR programs in the future, it is~     important to recognize that women have been underrepresented or not included in these studies~     to date. Therefore, the goal of this study is to determine the effects of AIT versus MICE on~     the risk of heart-related death, blood vessel health, and brain health in women who have~     heart disease, and who have been referred to a six-month, outpatient CR program.~   "
47109|NCT02950272|"~     The CARD study is a observational study which includes Chinese adolescents with diabetes aged~     18-30. The study aims to explore the status of disease treatment, self-management, the~     relationship between disease treatment and disease outcome in Chinese adolescents with~     diabetes.~   "
45893|NCT02966145|"~     The goal of this study is to identify the most reliable methods of analysis for tracking CBD,~     PSP, and o/vPSP over time. The results from this study may be used in the future to calculate~     statistical power for clinical drug trials. The study will also provide information about the~     relative value of novel imaging techniques for diagnosis, as well as the value of imaging~     techniques versus testing of blood, urine, and cerebrospinal fluid (CSF) 'biomarkers'.~   "
45894|NCT02966132|"~     The primary aim of the proposed study is to conduct a randomized controlled trial (RCT) to~     evaluate the efficacy of the Interactive Mobile Doctor (iMD) intervention targeting 150~     Chinese-, Korean- or Vietnamese-speaking male patients who smoke daily and have a scheduled~     clinic visit at Asian Health Services primary care.~   "
45895|NCT02966119|"~     RESTART- fr is a randomised controlled trial for adults surviving spontaneous intracerebral~     haemorrhage who had taken an antithrombotic drug (i.e. anticoagulant or antiplatelet~     medication) for the prevention of vaso-occlusive disease before the ICH.~      RESTART- fr is testing whether a policy of starting antiplatelet drugs (one or more of~     aspirin, clopidogrel, or dipyridamole, chosen at investigator's discretion) results in a~     beneficial net reduction of all serious vascular events over two years compared with a policy~     of avoiding antiplatelet drugs.~   "
45896|NCT02966106|"~     rTMS has appeared a potential new non-invasive antidepressant method, which implies~     non-convulsive focal stimulation of the brain through a time varying magnetic field. ).~     Research on rTMS reports of minimal side effects of the method . The majority of clinically~     controlled studies have used high frequency stimulation of the left frontal cortex .~      Fewer studies have used right prefrontal, which has less side effects, such as local~     discomfort and a lower risk of releasing epileptic seizures, than high frequency stimulation~     .Both stimulus models has been shown to have statistically significant antidepressant effect~     and recent research clearly indicates that low frequency rTMS of the right prefrontal cortex~     i associated with an antidepressant effect at the same level as the high frequency model.~     Therefore the investigators want to examine the antidepressant effect of a specific rTMS low~     frequency model in a clinical setting using a placebo controlled, randomized double blind~     design.~   "
45897|NCT02966093|"~     The primary purpose of this study is to compare the progression-free survival (PFS) of~     participants with radioiodine (131 I)-refractory differentiated thyroid cancer (DTC) and~     radiographic evidence of disease progression within the prior 12 months treated with~     lenvatinib 24 mg by continuous once daily (QD) oral dosing versus placebo.~   "
45898|NCT02966080|"~     Heparin is a blood thinner used to prevent blood clots in patients on a form of life-support~     called ECMO. Heparin can cause bleeding - the most common complication of ECMO. New materials~     used in ECMO machines may help prevent clots - this could allow the use of lower doses of~     heparin which might reduce the risk of bleeding. Our study will compare low dose to high dose~     heparin in patients on ECMO. We think low dose heparin may be adequate to prevent clotting,~     but may cause less bleeding and be safer for patients.~   "
45899|NCT02966067|"~     The study will be completed as a two part, prospective, single-centre, randomised controlled~     trial.~      Five volunteers (dentists) will be recruited in the first part of the study to evaluate and~     examine the microneedle device and its use. Based on those qualitative findings (individual~     interviews and focus group) modifications to the microneedle device will be implemented~     before part two of the study commences.~      Twenty volunteers will be enrolled in the second part of the study. A split mouth design will~     be used to compare the efficacy of an array of 2x3 pyramidal wet-etch silicone microneedles~     of 280µm height with a standard 30-gauge short hypodermic needle in the delivery of local~     dental anaesthetic solution. Quantitative and qualitative measurements of the pain~     experienced and the depth of anaesthesia achieved will be recorded and compared.~   "
45900|NCT02966054|"~     Epidemiologic data consistently indicate that colorectal cancer survivors can improve their~     quality-of-life and prognosis by engaging in physical activity. This study aims to build on~     this epidemiologic work and translate the findings to inform and change patient behavior. The~     specific aims are to: (1) Develop a mobile technology physical activity intervention among~     colorectal cancer patients who have completed therapy. (2) Conduct a 3-month pilot randomized~     controlled trial utilizing mobile technology to increase physical activity among 40 men and~     women who have completed standard cytotoxic chemotherapy for primary stage I-III colorectal~     cancer at the UCSF Helen Diller Family Comprehensive Cancer Center. Participants in the~     intervention arm will receive a Fitbit® for self-monitoring, interactive text messages, and~     educational print materials; participants in the control arm will receive educational print~     materials at baseline and will be given a Fitbit® after completion of the 3-mo. follow-up~     assessment.~   "
45901|NCT02966041|"~     To evaluate the effectiveness of a prophylactic dose of ondansetron in decreasing the~     incidence of post-operative nausea and vomiting in cardiac surgery patients after cessation~     of post-operative sedation. In patients who have undergone open heart surgery, a single~     prophylactic dose of ondansetron 4 mg IV given at the time of discontinuing propofol sedation~     will result in a 50% reduction of the rate of post-operative nausea and vomiting in the first~     24 post-operative hours compared to placebo.~   "
45902|NCT02966028|"~     The primary objective is to assess the effect of 2 dose levels of SNF472 (300 mg and 600 mg)~     compared to placebo on the progression of absolute change in coronary artery calcium volume~     score over a 12‑month (52 weeks) period in ESRD patients on HD~   "
45903|NCT02966015|"~     The aim of the study is to investigate the navigation of a newly developed catheter.~   "
45904|NCT02966002|"~     Patients who have undergone the Fontan procedure (a congenital heart surgery) may develop~     complications many years after their operation. Studies have shown that some of these~     patients develop an ongoing inflammatory state, which may be the cause of these late~     complications. Aspirin is a common over the counter anti-inflammatory medication used for~     many other chronic diseases. This study may help determine if aspirin therapy can limit the~     inflammation seen in Fontan patients and prevent these late complications.~   "
45905|NCT02965989|"~     This study evaluates if the implementation of an online platform with procedures and~     protocols, improve the knowledge of professionals and can have a health impact related to~     decreased contamination of blood cultures.~   "
45906|NCT02965976|"~     This randomized phase II trial studies how well botulinum toxin type A works in preventing~     complication after surgery in patients with esophageal cancer. Botulinum toxin type A may~     cause less complications of nausea and vomiting after surgery.~   "
45907|NCT02965963|"~     The purpose of this study is to examine the effect of dopamine infusion and dopamine-2~     receptor blockade on pulmonary capillary blood volume, diffusion, and the hemodynamic~     variables of pulmonary artery pressure, cardiac output, and pulmonary vascular resistance~     during exercise. Secondarily, this study will examine the effect of dopamine infusion and~     dopamine-2 receptor blockade on exercise tolerance.~   "
45908|NCT02965950|"~     This is a multicenter, open labeled, phase 2 clinical trial, where patients are stratified to~     one of two treatment groups based on upfront TP53 mutation status; i.e. TP53 mutated vs. TP53~     wt disease, and treated with dose-dense cyclphosphamide. Furthermore, patients included are~     stratified based on tumor stage; i.e. locally advanced breast cancer (M0 disease) or~     metastatic breast cancer (M1 disease). All participating cancer centers will prospectively~     include patients with breast cancer fulfilling the inclusion criteria.~      If patients do not respond to the experimental treatment as outlined in the protocol,~     treatment with dose-dense cyclophosphamide will be terminated, and further cancer treatment~     will continue at the treating oncologist's discretion. The response data for all patients who~     have received at least one chemotherapy course will be included in the final efficacy~     analysis.~      Tumor tissue, blood samples and radiology data will be collected before therapy starts, if~     therapy needs to be changed, and for patients with locally advanced breast cancer: at~     surgery. Response data will be evaluated closely during treatment, with clinical assessment~     of tumor size every two weeks for patients with locally advanced breast cancer and by~     radiology every eight weeks for patients with metastatic breast cancer. Evaluation of side~     effects/tolerance will be performed at every clinical visit, i.e. every two weeks for all~     patients included in the p53 trial.~   "
45909|NCT02965937|"~     The study aim is to evaluate the effectiveness of Story-Centred Care Intervention Program on~     reducing depressive symptoms, improving cognitive function, HRV, Blood pressure and quality~     of life in older adults living in a long-term care facility.~   "
45910|NCT02965924|"~     Phenylephrine hydrochloride ophthalmic solution is an alpha-1 adrenergic receptor agonist~     commonly used topically for dilation prior to ocular fundus examination. In the eye,~     phenylephrine acts locally as a potent vasoconstrictor and mydriatic by constricting~     ophthalmic blood vessels and the radial dilator muscle of the iris. Episcleral venous~     pressure (EVP) is a determinant of intraocular pressure (IOP) and can be measured~     non-invasively by venomanometry. Since phenylephrine is a vasoconstrictor, it may affect~     episcleral venous tone, but the effect on EVP is unknown. Understanding the physiology of~     episcleral veins helps us in better understanding of pathophysiology of glaucoma.~   "
45911|NCT02965911|"~     The purpose of this protocol is to conduct a trial in a selected population of patients with~     PBC based on an incomplete biochemical response after 12 months of UDCA therapy.~   "
45912|NCT02965898|"~     Acute pancreatitis (AP) may develop to chronic pancreatitis (CP). In Finland, the ethiology~     is alcohol in about 80% of the cases. Several symptoms lower the quality of life in CP~     patients, including abdominal pain, exocrine and endocrine pancreatic insufficiency.~      Recently, the investigators and others have found that vitamin D may protect from the~     formation of fibrosis on cellular level. The investigators hypothesized that after the first~     AP they may be able to protect the formation of fibrosis leading to CP with Vitamin D, and~     designed this RCT.~      The aim is to study whether the investigators can prevent CP with vitamin D substitute.~      In this randomized controlled patient study, the patients after their first AP are randomized~     to have either a normal recommended (10 μ) or a largest safe dose (100 μg). of vitamin D~     substitute daily. The patients are examined by MRI/MRCP imaging and laboratory tests at the~     baseline after recovery from AP and yearly then after.~      Primary endpoint is the development of parenchymal changes possibly related to fibrosis.~     Secondary endpoints are the development of CP with Mannheim criteria, CP related~     complications and mortality.~      The first analysis will be done after 3 years.~      The enrollment will begin 26.9.2016~   "
45913|NCT02965885|"~     A First-in-Human (FIH) study of TAS-116 in patients with advanced solid tumors was first~     initiated in Japan in April 2014 and has been ongoing since then. The study consists of a~     dose escalation phase and a dose expansion phase. Three dosing regimens of TAS-116, once~     daily (QD), every other day (QOD) and 5 days on/2 days off regimens in 21-day cycles, are~     being evaluated. This phase I study is also planned to enroll patients with advanced solid~     tumors in UK to confirm the MTD, safety, tolerability, and pharmacokinetics of TAS-116 in a~     Western patient population in the dose expansion phase. In addition, patients with HER2+ MBC,~     NSCLC harboring EGFR mutations or NSCLC harbouring ALK translocations will be further~     evaluated for safety, tolerability, and efficacy in 3 separate cohorts at recommended dose of~     TAS-116 on the 5 days on/2 days off regimen.~   "
45914|NCT02965872|"~     Thirty healthy individuals will be participants of the study. Participants will evaluate with~     the following assessment tools: Demographic datas; age, gender, height, body mass, will be~     recorded. Postural sway and limits of stability parameters will evaluate with computerized~     balance evaluation system (BERTEC) for seven times .~   "
45915|NCT02965859|"~     The study objective is to evaluate the safety and effectiveness of different doses of~     Metacavir Enteric-coated Capsules in treatment of chronic hepatitis B,as well as to find an~     appropriate clinical dosage by comparing the effect of different doses of treatment,in order~     to provide references of clinical trial of the next phase.~   "
45916|NCT02965846|"~     The objectives of this study are twofold •To evaluate the safety and efficacy of 0.1%~     AGN-195263 administered twice daily compared to its vehicle in patients with evaporative dry~     eye (EDE) •To evaluate the systemic pharmacokinetics of 0.1% AGN-195263 administered twice~     daily in patients with EDE~   "
45917|NCT02965833|"~     The purpose of this study is to evaluate CLEAR CARE® PLUS (CCP) compared to non-HYDRAGLYDE®~     multi-purpose contact lens solutions in presbyopes currently wearing soft contact lenses and~     experiencing symptoms of dryness.~   "
45918|NCT02965820|"~     The purpose of this study is to evaluate OPTI-FREE® PureMoist® (OFPM) compared to~     non-HYDRAGLYDE® multi-purpose contact lens solutions in presbyopes currently wearing soft~     contact lenses and experiencing symptoms of dryness.~   "
45919|NCT02965807|"~     This study aims to investigate the efficacy and safety of Bronchial Thermoplasty on moderate~     bronchial asthma in China, by observing the improvement of quality of life, the decrease of~     acute attack and emergence, as well as the incidence of related complications.~   "
45921|NCT02965781|"~     This study evaluates the safety and efficacy of SADBE in the prevention of recurrent herpes~     labialis in adults. Two-thirds of the participants will receive a SADBE solution, while the~     other third will receive only the vehicle as a placebo control. The solutions will be~     administered topically to the patient's arms. The study will compare a single-arm application~     versus a two-arm application versus two placebo doses on the arm.~   "
45922|NCT02965768|"~     The main objective of this study is to test if naltrexone, when taken in low doses, has an~     anti-inflammatory effect that may be associated with positive clinical outcomes in people~     with chronic fatigue syndrome (CFS). In part, the present study, is a continuation of prior~     work in which we showed that chronic fatigue symptoms are associated with immune activity,~     and that low-dose naltrexone might exert anti-inflammatory effects in fibromyalgia, which is~     thought to share some pathophysiological and clinical characteristics with CFS.~   "
45923|NCT02965755|"~     The goal of this research study is to determine if we can obtain personalized genetic~     information from a subject's blood sample that is similar to that obtained from a tumor~     tissue sample, and if we can use that information to make treatment suggestions.~   "
45924|NCT02965742|"~     The main objective of this study is to assess the concordance of body composition measures~     between two bone densitometry devices: the STRATOS by Diagnostic Medical Systems (DMS) and~     the Hologic QDR 4500 A by Hologic inc.~   "
45925|NCT02965729|"~     The purpose of the study was to examine the influence of step goals with pedometers to~     improve children's weight loss, physical activity, and psychosocial health during behavioral~     treatment. Children with overweight or obesity were assigned to receive the behavioral~     treatment alone, plus pedometers, or plus pedometers with step goals.~   "
45926|NCT02965716|"~     This phase II trial studies how well talimogene laherparepvec and pembrolizumab work in~     treating patients with stage III-IV melanoma. Biological therapies, such as talimogene~     laherparepvec, use substances made from living organisms that may stimulate or suppress the~     immune system in different ways and stop tumor cells from growing. Monoclonal antibodies,~     such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread.~     Giving talimogene laherparepvec and pembrolizumab may work better in treating patients with~     melanoma by shrinking the tumor.~   "
45927|NCT02965703|"~     This randomized phase IIa trial studies how well aspirin works in preventing colorectal~     cancer in patients with colorectal adenoma. Aspirin may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth~   "
45928|NCT02965690|"~     Total joint replacement is an efficacious treatment for osteoarthritis of hips and knees.~     Both total knee replacement (TKR) and total hip replacements (THR) have excellent implant~     survivorship. However, patients' satisfaction is lower in TKR than THR. A possible cause of~     the discrepancy is the unnatural knee kinematics after TKR. Various implants designs have~     been developed to solve the problem. However, most of their designs are based on experimental~     data and little has been studied about their kinematics in vivo. In this study, we will~     analyze the in vivo kinematics of the Global Medacta Knee Sphere (GMK Sphere) implant and~     compare it with a well documented design and implant (Nexgen Cruciate Retaining (CR), Zimmer~     Biomet). We assume our study will contribute the development of more satisfying knee~     implants.~   "
45929|NCT02965677|"~     To evaluate the safety and efficacy of the Paclitaxel Releasing Peripheral Balloon Dilatation~     Catheter (LEGFLOW) compared with the standard balloon (Admiral Xtreme) for the treatment of~     stenosis or occlusions in femoral popliteal artery.~   "
45930|NCT02965664|"~     A study to Establish Safety, Tolerability, and Efficacy of PresbiDrops (CSF-1) in Presbyopic~     Subjects.~   "
45931|NCT02965651|"~     The purpose of this randomized controlled trial is to evaluate the feasibility of introducing~     an innovative eHealth technology, the Embodied Conversational Agent (ECA), to diverse women~     from an urban outpatient setting.~   "
45932|NCT02965638|"~     The purpose of this study is to determine if maternal hyperoxygenation is an effective~     treatment for fetal left heart hypoplasia versus room air (placebo). This will be determined~     by measuring how well a baby's heart valves and their surrounding tissue are growing and~     functioning.~      In addition the investigators will examine brain growth using fetal ultrasound and MRI, and~     MRI of the child's brain after they are born to determine if there is greater neonatal brain~     maturity or mothers receiving oxygen compared to fetuses of mothers receiving placebo.~   "
45933|NCT02965625|"~     Human epicardial fat is the true visceral fat depot of the heart, and its regional~     distribution and physiology is of growing scientific and clinical interest. This study aims~     to characterize the expression profile and function of the epicardial and pericardial adipose~     tissue compartments of the heart (EAT and PAT). EAT and PAT adipose biopsies will be obtained~     from patients undergoing coronary artery bypass graft surgery (CABG) or valve replacement~     surgery.~   "
45934|NCT02965612|"~     The recent interest that the Specific Immunotherapy (ITS) has aroused is due to the positive~     potential role that could be played, in particular in the forms of allergic asthma, because~     this method constitute the only intervention (unlike that pharmacologic) able to act on the~     same causes of the disease, altering the natural history. To achieve this the investigator~     has tried to use the specific subcutaneous immunotherapy (SCIT), to which there are studies~     that, with scientific rigor, have demonstrated the benefits.~   "
45935|NCT02965599|"~     GSK3117391 has the potential to complement existing therapies in the treatment of chronic~     inflammatory disorders such as rheumatoid arthritis (RA). This study will evaluate the~     efficacy, safety and tolerability of oral GSK3117391 (Dose A) administered to subjects with~     severe RA despite treatment with disease-modifying anti-rheumatic drugs (DMARDs). This is a~     randomised, double-blind (sponsor open), multicentre, placebo-controlled, parallel group~     study. The total maximum study duration is approximately 10 weeks. Following a screening~     period of up to 28 days, subjects will be randomized (1:1) to placebo or GSK3117391 (Dose A)~     administered orally for a period of 28 days. Subjects will be followed up for 7 to 14 days~     post final dose. Approximately 40 subjects with severe RA will be randomised into the study.~   "
45936|NCT02965586|"~     compare the efficacy of intrathecal versus intravenous dexmedetomidine in attenuation and~     prevention of shivering in TURP under spinal anesthesia in a randomized controlled trial.~   "
45938|NCT02965560|"~     Acute-on-chronic liver failure (ACLF) is an ailment with high incidence of multiorgan failure~     (MOF) and consequent mortality. Systemic inflammation and susceptibility to infection are~     characteristic pathophysiological features. Prostaglandin E2 (PGE2) could subdue systemic~     inflammation and alleviate liver injury in mice model. However, there are no studies~     evaluating PGE2 as a predictor of early mortality.This study is designed to investigate~     whether plasma PGE2 and its receptors are associated with development of MOF and predict~     short-term mortality in patients with acute-on-chronic liver failure. By the way, we will~     also measure several other potential predictive factors (C-reactive protein,severe~     hyponatremia, Second infections,Diabetes mellitus,High density~     lipoprotein,interleukin-10,serum bile acids,ferritin,the neutrophil to lymphocyte~     ratio,urokinase plasminogen activator receptor,vWF-Ag levels and FVIII-to-PC ratios).~   "
45939|NCT02965547|"~     The purpose of this study is to determine the impact of remote ischemic preconditioning on~     dynamic cerebral autoregulation and related hematology indexes in healthy adults.~   "
45940|NCT02965534|"~     Reduced quality of vision and glare in twilight or night are frequently mentioned complaints~     within the optometric examination. A reason for these problems could be a myopic refractive~     shift in dark light conditions, commonly known as night myopia or twilight myopia.~      The aim of this study was to investigate whether quality of vision in twilight or night could~     be improved by a spectacle correction optimized for mesopic light conditions. Moreover,~     objective refraction in large pupils measured by aberrometry was compared to subjective~     mesopic refraction.~   "
45941|NCT02965521|"~     Epidemiologic data suggest that a Western dietary pattern after diagnosis of colorectal~     cancer increases risk of disease recurrence and death. High intake of red and processed meat,~     dairy, refined grains, and sweets/desserts characterize a 'Western dietary pattern'. This~     study aims to translate the epidemiologic findings into a patient-centered, web-based dietary~     intervention with text messaging to inform and modify users' dietary choices. The~     investigators' specific aims are to: 1) Develop a web-based dietary intervention with text~     messaging for colorectal cancer survivors; and 2) Conduct a 12-week pilot randomized~     controlled trial to determine the acceptability and feasibility of the dietary intervention~     among 50 colorectal cancer survivors. All participants will receive standard of care print~     materials regarding diet following a colorectal cancer diagnosis. Participants in the~     intervention group will also receive access to a web-based dietary intervention with text~     messaging for 12 weeks. This study will generate preliminary data on the effect of the~     intervention on dietary choices among colorectal cancer survivors for future studies.~   "
45942|NCT02965508|"~     The objective of this pragmatic randomized controlled trial is to compare the impact of~     physician directed home-based primary care with office-based primary care on~     hospitalizations, symptom control, caregiver burden, healthcare costs and other outcomes for~     older homebound adults and to conduct a dissemination and implementation evaluation to~     support future home-based primary care adoption~   "
45943|NCT02965495|"~     This is a multicenter, randomized, double-blinded, parallel, placebo-controlled, phase I/IIa~     clinical trial of YYD302 for treatment of osteoarthritis of the knee.~   "
45944|NCT02965482|"~     The study will compare a novel volumetric method (performed with the Aerogen Solo vibrating~     mesh nebulizer) with the standard two-minute tidal breathing protocol (performed with the~     Wright jet nebulizer) for methacholine challenge testing. The results will then give an~     indication as to whether the novel technique accurately assesses a given dose of methacholine~     with the new Aerogen Solo device. In addition, the reproducibility of test results with each~     method will be examined. Altogether, the findings from this investigation may provide means~     for better standardization of current testing guidelines.~   "
45945|NCT02965469|"~     This study will begin to assess the association between perceived stress and enhanced aging~     in persons living with HIV (PLWH). The investigators suspect this relationship may be~     mediated by increased aging within the immune system and subsequent low-level inflammation~     that commonly leads to multiple illnesses and frailty as one ages. The findings from this~     study will identify potential diagnostic and therapeutic targets to improve the health of~     aging PLWH which could also apply to HIV-uninfected populations.~   "
45946|NCT02965456|"~     Efficacy and Safety of IDP-121 Lotion and IDP-121 Vehicle Lotion in the Treatment of Acne~     Vulgaris~   "
45947|NCT02965443|"~     To perform a study that investigates the effectiveness of adding the SGLT2 inhibitor~     dapagliflozin + the dipeptidyl peptidase 4 (DPP-4) inhibitor saxagliptin vs placebo to revert~     from a BBIT regimen to a BOT regimen in patients with type 2 diabetes.~   "
45948|NCT02965430|"~     This is an open-label, comparative, and prospective pivotal study to demonstrate that~     AL-SENSE can indicate whether wetness sensed by pregnant women may be caused by amniotic~     fluid leakage rather than by urinary incontinence.~      Subjects arriving at the hospital will receive a single AL-SENSE to use until they notice any~     wetness.~      The blinded physician will perform a diagnosis according to the standard diagnostic methods~     (clinical assessment). The standard diagnostic methods will include the following tests: (1)~     Pooling test, (2) Ferning test, (3) pH test by pH paper. A positive Pooling test or positive~     result in both the pH test and the Ferning test is defined as a positive clinical assessment.~   "
45949|NCT02965417|"~     This is a single arm, phase 2, open-label, multicenter trial in patients with metastatic~     colorectal cancer (mCRC) and acquired resistance to anti-epidermal growth factor receptor~     (EGFR) monoclonal antibodies (mAbs) and documented mutation of extra cellular domain EGFR~     (ECD-EGFR).~   "
45950|NCT02965404|"~     The purpose of this study is to evaluate the safety of a live attenuated varicella vaccine in~     healthy adults, adolescents, and children.~   "
45951|NCT02965391|"~     Previous study showed circulating tumor DNA levels reflect the total systemic tumor burden.~     Circulating tumor DNA levels should decrease after complete surgery and could be increase as~     tumor recurrence. Few study investigated the half time of circulating tumor DNA in lung~     cancer patients that no criterion has been established of how to use it for surveillance.~   "
45952|NCT02965378|"~     This phase II/III trial studies how well FGFR inhibitor AZD4547 (AZD4547) works in treating~     patients with stage IV squamous cell lung cancer that has come back after previous treatment.~     This is a sub-study that includes all screened patients positive for the fibroblast growth~     factor receptor (FGFR) biomarker. FGFR can cause tumor cells to grow more quickly. AZD4547~     may decrease the activity of FGFR and may be able to shrink tumors.~   "
45955|NCT02965339|"~     Cardiac surgery patients have many risk factors for endothelial dysfunction (hypertension,~     atherosclerosis, dyslipidemia, chronic renal failure ...).~      It is likely that a significant number of patients suffering from a preexisting endothelial~     dysfunction. This endothelial dysfunction can be assessed by a molecular approach~     (determination of NO, ICAM1, VCAM1, IL8, endothelial microparticles ...). Extracorporeal~     circulation with ischemia-reperfusion causes a breach of particularly important glycocalyx as~     ischemia-reperfusion injury is. No studies have evaluated the time course of the~     infringement, and its association with the immediate post-operative complications (SIRS,~     coagulopathy, vasoplegic syndrome, renal failure). Only one study has regained an association~     between endothelial dysfunction during cardiac bypass surgery and postoperative cardiac~     surgery vasoplegic syndrome. A study in noncardiac surgery has regained an association~     between endothelial dysfunction (assessed by a vasoplegia test) and postoperative acute renal~     failure. Thus there is some data in the literature to suggest that the occurrence of~     postoperative complications (SIRS, coagulopathy, capillary leak syndrome, acute circulatory~     failure vasoplegic and acute renal failure) may result from the interaction between a~     pre-existing endothelial dysfunction and operative aggression (extracorporeal circulation).~     The onset of complications result from an interaction that depends on the importance of~     endothelial dysfunction at baseline.~   "
45956|NCT02965326|"~     The purpose of this study is to determine which biological marker, or association of~     biological markers, best predict clinical response of cystic fibrosis patients to CFTR~     modulators.~   "
45957|NCT02965313|"~     This is a Canadian, multi-centre, double-blind randomized controlled trial of an innovative~     vaginal surgery technique for correction of pelvic organ prolapse (POP) in women. Vaginal~     surgery is preferred as minimally invasive, however the investigators do not know if~     materials such as synthetic polypropylene mesh improve success, durability and~     cost-effectiveness long-term. The investigators principal goal is to compare the experimental~     bilateral sacrospinous vaginal vault fixation with synthetic mesh arms (BSSVF-M) to the~     current standard of sacrospinous ligament suspension with synthetic sutures (SSLS) over a~     timeline of 2 years. Patients and evaluators will be blind to technique.~   "
45958|NCT02965300|"~     The purpose of this study is to analysis the volatile organic gases(VOCs) in exhaled breath~     of pulmonary lesion patients and healthy controls, in order to find the difference of~     composition and concentration among groups.~   "
45959|NCT02965287|"~     The investigators have developed a diagnostic test for the evaluation of the presence of~     fetal malformations through metabolomic analysis of maternal peripheral blood serum by~     chromatographic techniques and mass spectrometry, and subsequent mathematical modeling~     analysis of the data by means of multivariate mathematical models specifically developed for~     this purpose. The study aims at determining the performance parameters (specificity,~     sensibility, positive predictive value (PPN), negative predictive value (NPV), etc.) of the~     test and its applicability. To do this, the investigators will use the serum samples of the~     patients enrolled in New Zealand in the SCOPE Study (www.scopestudy.net), an international~     study conducted between years 2004-2008.~   "
45960|NCT02965274|"~     Subjects to compare the single dose bioavailability of Torrent's Fluoxetine Tablets 20 mg and~     Sarafem® 20 mg Tablets of Warner Chilcott LLC, USA. Dosing periods of studies were separated~     by a washout period of 35 days.~   "
45961|NCT02965261|"~     Subjects to compare the single dose bioavailability of Torrent's Fluoxetine Tablets 20 mg and~     Sarafem® 20 mg Tablets of Warner Chilcott LLC, USA. Dosing periods of studies were separated~     by a washout period of 35 days.~   "
45962|NCT02965248|"~     This study is designed to evaluate the efficacy and safety of adjuvant hyperthermic~     intraperitoneal chemotherapy (HIPEC) with raltitrexed or oxaliplatin versus no HIPEC in~     locally advanced colorectal cancer~   "
45963|NCT02965235|"~     Postoperative cognitive dysfunction (POCD) is a subtle cognitive dysfunction, especially~     postoperative memory impairment lasting for weeks or months. The underlying~     pathophysiological mechanism of POCD remain unclear. The aim of this study is to explore the~     epigenetic changes during perioperative period and its correlation with POCD in surgical~     patients.~   "
45964|NCT02965222|"~     To establish embryo time-difference kinetics scoring model for embryo selection before embryo~     transfer. It is especially suitable for selective single embryo transfer, advanced infertile~     women, and patients with repeated transplant failure. It can effectively improve clinical~     pregnancy rate, improve embryo implantation rate and Rate of return home. Reduce the risk of~     multiple pregnancies.~   "
45965|NCT02965209|"~     The subject Novel Motorized Spiral Enteroscope (NMSE) represents a new technology which~     offers all of the advantageous options of spiral enteroscopy with a faster and less invasive~     approach. The system is similar to other currently marketed endoscopes in that it~     incorporates a flexible insertion tube, light source, digital imaging, and channels for~     passing accessories for sample collection or therapeutic interventions. The NMSE system is~     unique in that it incorporates a user-controlled motor contained in the endoscope's handle to~     rotate a spiral cuff located on the endoscope's insertion tube. Rotation of this cuff, which~     has soft spiral-shaped fins, pleats the small bowel on to the endoscope's insertion tube,~     thereby allowing rapid and atraumatic access deep into the small bowel. The system also~     includes a display monitor, a motor control unit, device to display measured motor current~     and signal torque, and a set of foot pedals. Motorization of the Spiral Enteroscope and~     limitation of rotation to a short cuff instead of a long overtube promise to accelerate the~     procedure, to facilitate insertion and to improve maneuvering the instrument in comparison to~     conventional spiral enteroscopy~   "
45966|NCT02965196|"~     The study will evaluate the efficacy of IV Dexamethasone in treatment low back pain as an~     adjunct to analgesics.~   "
45967|NCT02965183|"~     Examination of the correlation between adenoid hypertrophy and body temperature in candidate~     children for adenoidectomy after exercise~   "
45968|NCT02965170|"~     Validating a peptide-based laboratory test enabling the measurement of Tysabri® serum levels~     (pharmacokinetics, PK) in multiple sclerosis patients undergoing therapy. The results of this~     newly developed test will be compared to Tysabri® serum levels measured in parallel using an~     independent test. We will also simultaneously measure a pharmacodynamic marker of Tysabri®,~     receptor saturation levels on blood immune cells, which is thought to correlate with Tysabri®~     serum levels.~   "
45969|NCT02965157|"~     Chimeric antigen receptor (CAR) T cells targeting CD20 will be evaluated for safety and~     efficacy in patients with CD20+ B cell lymphoma. The CAR consists of a CD20 targeting~     antibody scFv with two intracellular signaling domains derived from CD3 zeta and CD28.~     Autologous T cells will be gene-engineered with the CAR gene using a retrovirus vector. Prior~     to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell~     infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of~     CAR T cells and efficacy.~   "
45970|NCT02965144|"~     This study builds on the limited body of existing literature combined with the results from~     the investigators' previous research conducted with 30 newly diagnosed patients with~     high-grade glioma (HGG) and 33 of their caregivers. This research established an overview of~     the daily life experiences when diagnosed with a HGG or being a caregiver. Descriptions of~     needs and preferences from time of diagnosis to one year exist. However, such data are still~     lacking the representation from long-term survivors (LTS) and their caregivers.~      This mixed methods study aims to address perspectives on daily life experiences of long-term~     survivors with HGG and their caregivers as well as the needs and preferences for support,~     rehabilitation and palliation.~      Separate telephone interviews with patients and their caregivers and self-reported~     questionnaires for patients will be conducted. The mixed methods design is a convergent~     sequential design using an identical sampling.~   "
45971|NCT02965131|"~     This study aims to investigate the effects of the anhepatic phase extended by temporary~     portocaval shunt on the sensitivity to desflurane administered at 0.6 age-adjusted minimum~     alveolar concentration and its associative postoperative cognitive function.~   "
45972|NCT02965118|"~     This is a phase III study to investigate the safety and efficacy of PAC-14028 cream in Atopic~     Dermatitis patients.~   "
45973|NCT02965105|"~     The aim of the study is to test the performance and safety of a newly developed intermittent~     catheter~   "
45974|NCT02965092|"~     Chimeric antigen receptor (CAR) consists of single chain variable fragment (scFv) and~     activation domain of T cell, and CAR-modified T cells (CAR-T cells) have the capabilities to~     recognize tumor associated antigen and kill tumor cells specifically. To a large part of~     patients with refractory or relapsed B cell malignancies, CAR-T cell adoptive immunotherapy~     can play a revolutionary effect in the field of cancer treatment. The investigators believe~     that the cells with CD137 will have a better chance of killing the leukemia cells. In the~     lab, the investigators constructed a second generation CAR containing CD137. The~     investigators start Phase I study aimed to relapsed or refractory B cell malignancies. The~     purpose of this study is to evaluate the safety and effectiveness of CD19 CAR-T cells in~     patients.~   "
45975|NCT02965079|"~     Investigators will aim to conduct an observational study in order to assess very thoroughly~     all patients implanted by Extracorporeal carbon dioxide removal (ECCO2R) in 10 critical care~     units of Paris and its surburb (APHP, Assistance Publique des hôpitaux de Paris).~      Secondary objectives will be:~        1. to assess efficacy and safety of ECCO2R,~        2. to compare the data issue from the registry to others studies assessing the same~          population and to other centers and~        3. to compare the different ECCOR devices in terms of efficacy and adverse events.~   "
45976|NCT02965066|"~     The aim of the study is to test the performance and safety of a newly developed intermittent~     catheter in healthy volunteers.~   "
45977|NCT02965053|"~     This study is a randomized study designed as a 2x2 cross-over in two periods (Period 1 and~     Period 2) to assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of~     EOS789 in patients with chronic kidney disease (CKD) and hyperphosphatemia receiving~     hemodialysis. Period 1 is double-blind and Period 2 is open-label. Period 1 and Period 2 are~     identical with regard to the design, inclusion/exclusion criteria, and assessments. EOS789~     and its combination with sevelamer carbonate are tested in Period 1 and Period 2~     respectively.~   "
45978|NCT02965040|"~     For subjects with normal renal function or severely impaired renal function, this study will~     evaluate the pharmacokinetics of roxadustat and its main metabolites in plasma and urine.~      For subjects with end stage renal disease (ESRD) on continuous ambulatory peritoneal dialysis~     (CAPD) or automated peritoneal dialysis (APD), this study will evaluate the pharmacokinetics~     of roxadustat and its main metabolites in plasma, urine and dialysate.~      For subjects with ESRD on hemodialysis (HD) or hemodiafiltration (HDF), this study will~     evaluate the pharmacokinetics of roxadustat and its main metabolites in plasma, urine and~     dialysate and also the effect of dialysis on the pharmacokinetics of roxadustat and its main~     metabolites.~   "
45979|NCT02965027|"~     Mild traumatic brain injury (mTBI) caused by blast effects of explosive devices has been~     called the signature injury of soldiers who served in the Iraq and Afghanistan conflicts.~     mTBI can also occur from impact or hitting the head on an object or the ground. Although~     termed mild in comparison to major brain injuries, people with mTBI can have problems with~     their memory and concentration. People with mTBI can also find they are more irritable, have~     more anxiety, and have trouble with their mood and sleep.~      The purpose of this study is to see if a medication called prazosin can help treat chronic~     headaches in people with mTBI. The Food and Drug Administration (FDA) has approved prazosin~     for treating people with high blood pressure. At this time, the FDA has not approved prazosin~     in the treatment of mTBI or headaches. Some people who have posttraumatic stress disorder~     (PTSD) and have been taking prazosin for their medical conditions or who have taken it in~     research studies have said they have fewer headaches.~   "
45980|NCT02965014|"~     This three-arm cross-over cluster-randomized trial will develop, test, and compare the~     efficacy of two delivery formats of the Women's CoOp (WC), which is designed to provide risk~     reduction and empowerment skills, as well as linkages to healthcare services for~     substance-using women. The current study will develop a revised version of the WC and~     evaluate the relative efficacy of a face-to-face (face-to-face WC), mobile Health application~     (mHealth WC) delivery format, and HIV counseling and testing (HCT) as a control to reduce~     risky sexual behaviors, reduce substance use, and increase sexual negotiation among young~     (18-25 years) substance-using African American women who are sexually active and have not~     recently been tested for HIV in three NC counties.~   "
46206|NCT02962063|"~     The purpose of this study is to test the safety of adding a new drug, durvalumab (also called~     MEDI4736), to chemoradiation using two standard chemotherapy drugs, carboplatin and~     paclitaxel. The investigators want to find out what effects, good and/or bad, this~     combination has on the patient and cancer.~   "
45981|NCT02965001|"~     Head and neck cancer (HNC) is the 6th most common cancer worldwide. In the last decade, there~     has been made substantial improvements in diagnosis, staging and treatment of HNC. The~     overall survival has improved, but for some subgroups it is unchanged and therefore new~     prognostic and surveillance methods are warranted.~      One of the hallmarks in cancer is the ability to invade the surrounding tissue and~     metastasize. Studies have shown that the urokinase proteolytic plasminogen activator (uPA)~     and its receptor (uPAR) are present at the very front of the invasive tumor and they are~     considered essential in cancer invasion and metastasis. Consequently, an uPAR-targeted tracer~     offers a very promising target for functional PET imaging and may be a stronger prognostic~     marker compared to routine FDG-PET/CT. We wish to clarify how uPAR-PET/CT correlate to~     patient outcome compared to routine FDG-PET/CT in patients with HNC in the pharynx, larynx~     and oral cavity, who are referred to curative intended radiotherapy. In this project all~     participants have an uPAR-PET/CT scan performed before initiation of the routine radiotherapy~     and the prognostic efficacy is determined by assessment of the recurrence rate and mortality~     at routine clinical follow-up.~   "
45982|NCT02964988|"~     The purpose of this study is to investigate the applicability of urokinase plasminogen~     activator receptor (uPAR) Positron Emission Tomography (PET) / CT molecular imaging in~     patients with metastatic castration-resistant prostate cancer (mCRPC)~   "
45983|NCT02964975|"~     Several meta analysis comparing successful Percutaneous Coronary Intervention of Chronic~     Total Occlusion (PCI-CTO) with unsuccessful PCI-CTO showed that there is significant~     reduction in short-term and long-term mortality. To our knowledge till today no prospective~     randomized trial compared percutaneous revascularization of CTO with optimal medical therapy.~     For this reason quality of live improvement is one of the most important indications for~     revascularization in elective patients with CTO. In contemporary literature Seattle Angina~     Questionnaire (SAQ) is a psychometrically solid disease-specific instrument designed to~     assess the functional status of patients with angina. It comprises 19 questions that quantify~     five clinically relevant domains: physical limitation, angina stability, angina frequency,~     treatment satisfaction and disease perception/quality of life.~      In this open prospective study patients with CTO of coronary artery will be randomized in two~     groups: first - patients with percutaneous coronary intervention of chronic total occlusion~     with optimal medical therapy and second group - patients with only optimal medical therapy~     (control group). Primary endpoint will be quality of life and secondary endpoints will be~     mayor adverse cardiovascular events (MACE). All patients will complete Seattle Angina~     Questionnaire before randomization and after 6 months of follow-up.~   "
45984|NCT02964962|"~     The objective of the REPRISE EDGE 29 mm EU study is to evaluate performance and safety of the~     29 mm LOTUS Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in~     symptomatic subjects with calcific, severe native aortic stenosis who are considered at~     extreme or high risk for surgical aortic valve replacement (SAVR).~   "
45985|NCT02964949|"~     Atrial fibrillation is when the heart's two upper chambers (called atria) beat chaotically~     and irregularly, out of coordination with the two lower chambers (called ventricles) of the~     heart. This can lead to blood clots forming in the heart chamber.~      Patients with atrial fibrillation will be treated with either 60 mg or 75 mg of edoxaban for~     up to 12 months, with a 2-4 week follow-up, after which their participation is complete.~      Blood samples will be collected before the first dose of study drug (Day 0), and on Days 30,~     90 and 360 (at pre dose, 1-2 hours post dose and 4-8 hours post-dose).~   "
45986|NCT02964936|"~     The objective of this study is to evaluate the efficacy and the safety when ASP1517 is~     intermittently administered in Erythropoiesis Stimulating Agent (ESA)-untreated non-dialysis~     chronic kidney disease patients with anemia.~   "
45987|NCT02964923|"~     The purpose of the study is to investigate these effects of Second-Generation Antipsychotic~     (SGAs) on glucose and lipid metabolic parameters in patients with schizophrenia, and explore~     the relationship between genes polymorphisms (such as drug metabolic enzyme, Endogenous~     Cannabinoid Receptor Type 1(CB1) and so on) and the SGAs-induced glucose and lipid metabolic~     disorder in Chinese Han persons with schizophrenia who are taking one of the SGAs(olanzapine,~     risperidone or ziprasidone).~   "
45988|NCT02964910|"~     This phase IV clinical study was designed to evaluate the immunogenicity and safety of the~     recombinant Hepatitis E vaccine(Hecolin®), manufactured by Xiamen Innovax Biotech CO., LTD.,~     in the chronic Hepatitis B patients on the clinical stability and aged over 30 years of age~     at enrollment. The study volunteers will receive the 3 doses of Hecolin® administered~     intramuscularly according to a 0-1-6 month schedule.~   "
45989|NCT02964897|"~     Veterans leaving incarceration and re-entering their communities (often described as~     reentry Veterans) face a number of challenges, including uncertainty about housing,~     vulnerability to substance use and relapse, on-going mental health concerns, and often~     multiple health conditions require timely continuity of care. The purpose of the project is~     to increase support for Veterans post-incarceration through the addition of trained peers~     with lived experience of being a Veteran and a history of incarceration. Emphasis will be on~     peers who will help link Veterans to Veterans Health Administration (VHA) services, including~     housing and healthcare. Peers will provide linkage with Health Care Reentry Veterans program~     specialists, transportation to appointments, and support in community reintegration. Peers~     will assist reentry veterans to make a successful transition and get and stay engaged in~     their care.~   "
45990|NCT02964884|"~     Neurofibromatosis Type 1 (NF1) is a common genetic disorder that is associated with a four~     times greater risk of learning disabilities, including reading disabilities, and a deficiency~     of neurofibromin - a protein important in a signaling pathway that regulates learning and~     memory. Our previous work (NS49096) demonstrated that school-age children with NF+RD can~     respond to standard phonologically-based reading tutoring originally developed to treat~     reading disability in the general population. Combining our work with that by other~     researchers suggesting that a medication (Lovastatin) may counteract the effects of the~     deficient neurofibromin, and possibly ameliorate learning disabilities in NF1, the~     investigator propose to examine the synergistic effects of medication plus reading tutoring.~   "
46359|NCT02960061|"~     The investigators intend to conduct a randomized controlled study to find if combining HIPEC~     (hyperthermic intraperitoneal perfusion chemotherapy) with post-neoadjuvant chemotherapy D2~     resection could improve survival for patients with advanced gastric cancer, while comparing~     with the traditional approach of D2 resection after neoadjuvant chemotherapy.~   "
45991|NCT02964871|"~     RAPID-LTCF is a stratified, block-randomized controlled trial to assess the effectiveness of~     a simple ARI case definition, rapid influenza diagnostic test (RIDT) with wireless~     transmission of results, and provision of infection control guidance when influenza is~     detected. Because of the nature of the intervention, blinding is not possible. Sites will be~     initially recruited for a study of respiratory infections within LTCFs. After acceptance~     into the study, sites will be matched in terms of bed capacity, location, and other features~     prior to randomization.~   "
45992|NCT02964858|"~     The purpose of this study is to compare standard dose radiation of 45 Gray(Gy) in 25~     fractions in Non Hodgkin's Lymphoma- Diffuse Large B cell Lymphoma (NHL-DLBCL) to that of 36~     Gy in 20 fractions.~      The role of radiation in NHL-DLBCL has been addressed in large cooperative trials showing~     improvement in overall survival and progression free survival with combined modality~     treatment. The doses of radiation used in these trials are heterogeneous ranging from 30-55~     Gray(Gy). There is uncertainty about the optimal dose of radiation needed in aggressive~     lymphomas. A dose response phenomenon is known in Non- Hodgkin's Lymphoma. Late effects of~     higher dose radiation in the form of higher risk of stroke, myocardial infarction, thyroid~     abnormalities and secondary breast cancer are being increasingly identified. Hence it is~     essential to optimize the dose of radiotherapy for lower toxicity without compromising on~     efficacy.~   "
45993|NCT02964845|"~     Women recently released (RR women) from incarceration constitute a vulnerable group~     characterized by high rates of untreated HIV and sexually transmitted infections (STIs),~     substance use disorder (SUD), mental health (MH) disorders and trauma. This interconnected~     syndemic requires helping RR women to overcome multiple internal and structural care~     barriers. This R34 builds on work conducted by the PI in a NIDA-funded K23 project, in which~     an intervention called Women's Initiative Supporting Health (WISH) was developed to improve~     RR women's engagement in HIV, Hepatitis C (HCV), and primary medical care using Self~     Determination Theory (SDT). The proposed R34 project, a natural extension of this prior work,~     will conduct a pilot randomized controlled trial (RCT) of the WISH intervention to examine~     feasibility, acceptability, and preliminary effectiveness.~   "
45994|NCT02964832|"~     To improve the quality of CPR education, we want to assess the validity and reliability of~     the feedback depth measured by smartphone applications according to the smartphone attachment~     sites as an educational tool. However, in the prior study, armband method showed~     overestimated chest compression depth. The reason of the overestimation was analyzed that the~     weight of the smartphone amplified the inertial force to produce additional linear movement.~     In this study, we will make new device to fix the smartphone on the arm and on the hand and~     compare the chest compression depth between CPR manikin and smartphone application.~   "
45995|NCT02964819|"~     This project will analyze the influence of interferential current therapy in an exercise~     program for individuals with a unilateral impact syndrome diagnosis. To that end, volunteers~     of both genders, aged 18-59 years, had an unilateral, unilateral pain in the shoulder with~     more than 3 months duration, at least grade 4 pain by the numerical scale of pain assessment,~     positivity In at least 2 of 3 orthopedic tests for impact syndrome, will be randomized into~     the following groups: exercise group, exercise + ultrasound group, exercise group +~     interferential current. Sixteen consecutive treatment sessions will be performed, and the~     volunteers will be evaluated before and after, by means of the following instruments:~     Numerical scale of evaluation of pain, Shoulder pain and disability index (SPADI),~     Pain-Related Catastrophizing Thoughts Scale, being applied the Numerical scale of evaluation~     of pain at the end of Each session and one month after the end of treatment.~   "
45996|NCT02964806|"~     Decreased bowel function and loss of appetite in patients who underwent pancreaticobiliary~     surgery contribute impaired nutritional status in postoperative period. It can also affect~     perioperative and oncologic outcomes negatively. Therefore it is important to improve~     nutritional status in postoperative period by supply tailor-made optimal diets. The~     investigators have developed customized postoperative diets for pancreaticobiliary cancer~     patients. The investigators expect that customized diets for pancreaticobiliary patients will~     increase the food intake rate and contribute a improvement of perioperative outcomes and even~     oncologic outcomes.~   "
45997|NCT02964793|"~     Fetal Growth Restriction (FGR) remains a challenging topic for clinicians, researchers and~     policy makers, and a central question is how to improve the performance of screening during~     pregnancy in order to provide appropriate care. The recent recommendations and reporting of~     French results have raised awareness of the need to improve growth screening in France. Based~     on the existing literature, the hypothesis is that a greater investment in growth monitoring~     based on a more rigorous interpretation of information available from routinely implemented~     clinical assessment and ultrasound will allow for significant gains in detection. The current~     context provides the opportunity to evaluate the application of a training program for serial~     plotting of Symphysis Fundal Height (SFH) and Estimated Fetal Weight (EFW) on customised~     charts. This intervention is consistent with French guidelines which support the monthly~     measurement of SFH, the use of Customised Fetal Weight Reference (CFWR), in particular for~     referral US (Ultrasound) examinations, and the longitudinal interpretation of growth. These~     guidelines were recently restated in the clinical practice recommendations issued by the~     French College of Obstetricians and Gynecologists.~      The intervention tested in the trial will include training of professionals for~     standardization of SFH measurement, introduction of software, and recommendations for growth~     interpretation and referral examinations. Expected benefits are an increase in antenatal~     identification of growth restricted fetuses without an increase in the FP rate. Such a~     program will allow identified Small for Gestational Age (SGA) fetuses to receive appropriate~     antenatal care. This intervention could double the detection rate of SGA births from 20 to~     40%, corresponding to 32 000 infants nationwide annually for whom antenatal care could be~     improved.~      Main objective: To test the effectiveness of the serial plotting of SFH and EFW measures on~     customised percentile charts supported by provider training, versus standard antenatal care,~     to improve the detection of FGR. The aim of the investigators is to double rates of antenatal~     detection from 20 to 40% among SGA infants, defined as a birthweight under the 10th~     percentile for GA.~   "
45998|NCT02964780|"~     The main objective of the study is to gain insight in the early dynamics and mechanisms of~     recovery of liver disease and sex steroid metabolism during weight loss in obese men and~     women and to investigate whether surgical weight loss has differential effects as compared to~     weight loss with life style measures. In addition, we want to evaluate the postprandial~     hypoglycemic reactive syndrome (PPHRS) in these patients using a standard chewable meal.~      Secondary objectives are investigating determinants for the changes in sex steroids, liver~     disease and PPHRS. Possible determinants to be investigated are adipocytokine secretion~     patterns, body composition, resting metabolism rate, weight loss per se and changes in fat~     distribution, parameters of fatty acid metabolism, … .~   "
46360|NCT02960048|"~     To evaluate the effectiveness of Michigan-type occlusal splint and anterior repositioning~     splint in patients with temporomandibular joint anterior disc displacement with reduction.~   "
46001|NCT02964741|"~     This study investigates whether non-invasive brain stimulation, given for 20 minutes/once per~     day for ten days (M-F) can reduce migraine pain. Thirty patients will receive this treatment,~     while thirty will receive a sham procedure. Up to thirty healthy volunteers will be asked~     to undergo baseline assessments only (imaging, but no brain stimulation). Healthy volunteer~     data may be used from a prior study (NINDS-K23062946 project [IRBMED #HUM00027383; Dr.~     Alexandre DaSilva, Principal Investigator]).~   "
46002|NCT02964728|"~     The effect of botulinum neurotoxin type A intradermal injection in will be evaluated in 4~     patients with clinical diagnosis of burning mouth syndrome involving the anterior two-thirds~     of the tongue and the lower lip for at least 6 months, refractory to common pharmacological~     treatments. Pain severity will be measured by the visual analog scale (VAS) indicating~     average week pain before injection. Each patient will be injected with a total dose of 16~     units (dilution: 2 ml saline) of incobotulinumA: 4 units into each side of the lower lip and~     4 units into each antero-lateral side of the tongue. In order to determine if a placebo~     effect may be involved, we will inject 2 additional patients with saline solution using the~     same volumes and the same injection sites. Patients will be evaluated at 48 hours and then at~     4, 8, 12, 16 and 20 weeks after the treatment. Patients treated with placebo will be treated~     after 4 weeks with incobotulinumA with the same dose reported above.~   "
46003|NCT02964715|"~     Non-Alcoholic Fatty Liver Disease( NAFLD) is common in patients with type 2 diabetes.~     Empagliflozin, an FDA-approved oral medication used to treat type 2 diabetes, has been shown~     to reduce production and deposition of fat in the liver in animal experiments. There is~     little published evidence that this is so in Asian patients with type 2 diabetes. The~     investigators designed this pilot study to determine if use of empagliflozin for 6 months in~     patients with type 2 diabetes can improve scan, blood marker and biopsy features of NAFLD.~   "
46004|NCT02964702|"~     To evaluate the efficacy and safety of catheter-based thrombectomy for reperfusion by~     removing a thrombus in a cerebral blood vessel in patients with acute cerebral infarction~     (within 8 hours after onset), in whom intravenous administration of tissue plasminogen~     activator (t-PA) is not indicated or reperfusion cannot be achieved by intravenous t-PA~     administration.~   "
46005|NCT02964689|"~     The aim is to determine the recommended phase 2 dose (RP2D) of binimetinib in combination~     with pemetrexed and cisplatin, and to demonstrate that the combination is feasible and has~     preliminary activity in previously untreated patients with advanced NSCLC and documented KRAS~     mutations.~   "
46006|NCT02964676|"~     To evaluate the clinical efficacy (intraocular pressure reduction , success rate, the number~     of antiglaucoma medication) and safety of ab interno trabeculectomy (AIT) with Trabectome in~     Chinese PACG .~   "
46007|NCT02964663|"~     The purpose of this study was to compare CO measured by two easy to use non-invasive~     monitors, the esCCO (Nihon Kohden, Tokyo, Japan) to the Volume View (Edwards Lifesciences,~     Irvine, USA) and to assess their trending ability in patients undergoing cardiac surgery.~   "
46008|NCT02964650|"~     The investigators have demonstrated that they can reliably identify an optimum heart rate~     range for contractility of the left ventricle in patients with chronic heart failure (CHF).~     They have also demonstrated in an acute cross-over study that keeping the heart rate in this~     range (versus standard rate-response programming) in patients with CHF is associated with~     increased exercise time on a treadmill (around 60s or 10%). They now want to explore in a~     randomised, placebo-controlled trial whether optimal programming versus standard~     rate-response programming for 6 months leads to appreciable improvements in exercise time and~     quality of life, while having no adverse effects on left ventricular function and battery~     longevity.~      60 patients with CHF and a pacemaker will undergo the non-invasive echocardiographic~     assessment to establish the force frequency relationship and the optimal heart rate for~     contractility. They will then perform a treadmill walk test and fill out a quality of life~     questionnaire. They will then be randomised to optimal rate-response settings or standard~     rate response settings and followed up at 6 months at which point the tests will be repeated.~   "
46009|NCT02964637|"~     To establish diagnostic tools to make an accurate clinical and pathological diagnosis of~     patients with clinical FTLD syndromes~   "
46010|NCT02964624|"~     Osteoarthritis (OA) is the most common type of degenerative joint disease. Furthermore,~     despite its incidence being amongst the highest in chronic diseases, effective biomarkers,~     diagnostic aids and imaging technology are not available to assist in the management of OA.~     Mounting evidence suggests that non-pharmacological treatment such as exercise/physical~     therapy may lower the risk for onset or progression of OA by mitigating inflammation.~     However, the mechanical unloading and overloading, as seen in disuse and overuse, lead to~     upregulation of several proinflammatory molecules and enhance tissue degradation, whereas,~     dynamic moderate mechanical loading exerts anti-inflammatory and anti-catabolic effects on~     articular cartilage by suppressing mediators of inflammation. However, the lack of robust~     biomarkers to measure the effectiveness of physical therapies, represent a critical gap in~     biotechnology, obliterating the progress in the optimal application of these therapies. Our~     central hypothesis is that the circulating levels of specific molecules could serve as robust~     biomarkers for quantitative measures of OA burden, prognosis, progression or treatment~     efficacy. The objective of this project is to identify and evaluate mediators that serve as~     biomarkers of OA progression and treatment. Recently, high mobility group box chromosomal~     protein 1 (HMGB-1) has been suggested to be markedly upregulated in OA. However, presently~     there are no inhibitors of HMGB1 that could be used therapeutically. Previous results showed~     that that gentle exercise is the only tool that can mitigate HMGB1 production by local and~     systemic macrophages, and thus inflammation. Serum concentration of HMGB1 will be evaluate as~     a biomarker in OA patients and relate it to the functional capacity of knee joints in OA~     patients after rehabilitation protocol (RP). The RP will consist of three rehabilitation~     session/week during eight weeks. The efficacy of a RP will be evaluated by functional scale~     Western Ontario & McMaster Universities Osteoarthritis (WOMAC), Scale for the measurement of~     health related quality of life using EuroQol five dimensions questionnaire (EuroQOL-5D),~     Visual Analog Scale (VAS), and physical function tests. Besides all clinical assessment,~     serum levels of classical pro-inflammatory cytokines, hyaluronan and HMGB1 will be evaluated.~     A correlation of physical improvement after RP and serum biomarkers will be performed.~   "
46011|NCT02964611|"~     The aim of this study is to compare personality and social cognition changes, including~     emotion detection and self-awareness, and neuroanatomical correlates in patients, and how~     that affects the caregiver-patient relationship.~   "
46024|NCT02964442|"~     Brown adipose tissue (BAT) thermogenesis can be assessed by IR thermography, the accompanying~     increase metabolic rate can be measured by whole body calorimetry and BAT volume can be~     precisely measured by MRI. The aim of the study is to validate IRT for BAT thermogenesis~     against the present gold standard 18-FDG-PET scan, quantify BAT volume by fat fraction MRI~     and measure the accompanying increase in BMR by whole body calorimetry among healthy~     euthyroid subjects.~   "
46025|NCT02964429|"~     The main purpose of this study is the determination of the in-vivo ultrafiltration~     coefficient (in-vivo KUF) for Diacap Pro dialyzers following routine dialysis prescription in~     the United States.~   "
46012|NCT02964598|"~     Adolescence associates with alterations in sleep-wake organization, such as later circadian~     phase preference. Simultaneously external pressures, such as evening-driven social activities~     increase. These may lead to delayed sleep phase, which may cause serious problems for waking~     up at socially accepted times, and absenteeism from the school may follow. This project aims~     at tracking risk factors for later circadian regulation problems, characterizing~     interconnections of biological, psychological and behavioural mechanisms that maintain or~     induce poor sleep regulation in adolescence, and building a cost-effective,~     theoretically-based sleep intervention for adolescents with delayed sleep phase. This~     randomized control trial capitalizes on a new population-based cohort of 16-17-year olds.~   "
46013|NCT02964585|"~     The investigators hypothesize that Cana may be able to improve number and function of CD34+~     endothelial progenitor cells. The investigators also propose that this expected~     cardiovascular benefit is independent of HbA1C reduction.~      In this proposed study the investigators plan to recruit patients with type 2 diabetes of~     less than or equal to 15 years duration (in early phase of diagnosis), who are on a stable~     dose of metformin for at least 3 months but still remain inadequately controlled with HbA1C~     between 7% and 10% (both values inclusive), but not overtly out of control (> 10% of HbA1C).~      Subjects will begin taking 100 mg of Cana or placebo after initial 4 weeks. Subjects will be~     withdrawn from the study if the medication or placebo is not tolerated.~   "
46014|NCT02964572|"~     -  Single-center, prospective, active-controlled, open, randomized, 2 arm parallel,~          interventional, exploratory pilot~        -  Type 2 diabetic patients with high cardiovascular risks who have inadequate glycaemic~          control with metformin-based oral hypoglycemic agents will be prescribed glimepiride~          (comparison group) or empagliflozin (study group) for 60 days (plus or minus 32 days) as~          add-on therapy~        -  Changes in IL-1beta secretion, serum beta-hydroxybutyrate concentration, and NLRP3~          inflammasome activity from baseline to final timepoint will be assessed.~   "
46015|NCT02964559|"~     This phase II trial studies how well pembrolizumab works in treating patients with skin~     cancer that has spread from where it started to nearby tissue, lymph nodes, or other parts of~     the body. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of~     tumor cells to grow and spread.~   "
46016|NCT02964546|"~     Atrial fibrillation in the elderly is a complex condition due to the high number of~     frequently associated comorbidities such kidney disease. Direct oral anticoagulants~     (dabigatran, rivaroxaban and apixaban) are indicated for preventing thromboembolic events but~     renal function should be closely monitored for this age group when these drugs are used.~     Dosing recommendations for prevention of stroke are based on renal clearance of creatinine~     (ClCr) estimated using the Cockcroft-Gault formula. It is well known that ClCr estimates~     predict a steeper decline with advancing age than Glomerular Filtration Rate (GFR) estimates.~     This raises the possibility that substitution of commonly reported GFR for estimated CrCl~     could result in different plasmatic concentrations of oral direct anticoagulants. The aim of~     this study was to compare estimates of ClCr and GFR and determine the impact on the plasmatic~     concentration of these drugs in elderly patients with non-valvular atrial fibrillation.~   "
46017|NCT02964533|"~     Chronic fatigue syndrome is a group of syndrome and is prevalent in adult. Thunder-fire~     moxibustion is a commentary therapy belonged to acupuncture therapy. To evaluate the effect~     and safety of thunder-fire moxibustion therapy for chronic fatigue syndrome, we apply a~     randomized controlled trial by recruiting chronic fatigue syndrome patient as subject,~     applying thunder-fire moxibustion on shenque acupoint contrasted to common moxa-stick~     moxibustion, taking fatigue rating scale score, the content of CD3+、CD4+、CD8+、CD4+/CD8+ as~     evaluation indexes. The treatment time is 20-30 minutes per session, 3-4 times a week, there~     are totally 15 sessions.~   "
46018|NCT02964520|"~     This study evaluates if individuals with moderate to high trait anxiety can learn how to~     self-regulate their brain waves and reduce their trait anxiety in ten sessions of EEG~     alpha-theta neurofeedback training. Half of the randomly assigned participants will receive~     alpha/theta neurofeedback training while the other half will receive a two-part control~     protocol where low beta and beta waves will be uptrained in and downtrained in in successive~     sessions.~   "
46019|NCT02964507|"~     This is a combination Phase I and Phase II study, with an aim to evaluate the combination of~     GSK525762 and fulvestrant in women with advanced or metastatic ER+ breast cancer, who have~     disease that has progressed after prior treatment with at least one line of endocrine~     therapy.~      The objectives of the study are to first identify, in open-label single-arm Phase I, a~     recommended Phase II dose of GSK525762 that may be combined safely with fulvestrant. Phase I~     will follow a modified toxicity probability interval (mTPI) design, and a sentinel group will~     be evaluated first for dose-limiting toxicity and further expanded to collect additional~     safety data. This will be followed by a double-blind, randomized controlled Phase II, to~     identify the clinical activity of the two study treatments when given in combination. The~     composition of Phase II will be selected at the end of Phase I.~      Approximately, up to 140 subjects and 154 subjects will receive study treatment in Phase I~     and Phase II respectively. A completed subject will be one who is followed until death.~   "
46020|NCT02964494|"~     The investigators propose the creation and maintenance of a comprehensive registry for~     patients with the diagnosis of Congenital Dyserythropoietic Anemia (CDA) in North America.~     The goal of this registry will be to collect long-term confidential data on patients with CDA~     in the US, Canada, and Mexico and create a bio-repository of de-identified patient blood and~     bone marrow specimens as a tool for the investigation of epidemiology, natural history,~     biology, and molecular pathogenetic mechanisms of CDA.~   "
46021|NCT02964481|"~     The purpose of this study is to to determine the penetrance of known and probable pathogenic~     variants in genes and the factors that contribute to penetrance in a population of children~     and adults in the United States exposed to Malignant Hyperthermia (MH) trigger agents.~   "
46022|NCT02964468|"~     The aim of this study is to evaluate the increase of radiation dose administered in patients~     diagnosed with locally advanced rectal cancer in terms of ypRC with tolerable toxicity, using~     IMRT (concomitant boost technique).~   "
46023|NCT02964455|"~     The phase I study is to determine the maximum tolerated dose and dose limiting toxicity of~     docetaxel and nedaplatin prescribed twice weekly in combination with concurrent chest~     radiotherapy in patients with locally advanced esophageal squamous cell carcinoma.~   "
46026|NCT02964416|"~     Several modalities have been studied to prevent coughing during emergence, including~     extubation in a deep plane of anesthesia but have proved to be unreliable. So far, no~     reliable method is recommended as standard of care. The advantages of administering tramadol~     includes a long duration of action, rapid recovery, limited depression of respiratory~     function and no effect on platelet makes it a safe medication to use for neurosurgical~     patients after craniotomy. The primary objective of the study is to observe the effect of~     single dose of tramadol (1mg/kg) administered 45 minutes before extubation on hemodynamic~     response (measurement of B.P and H.R) during extubation.~   "
46027|NCT02964403|"~     Acute pancreatitis is the most common and feared complication of ERCP, occurring after 1% to~     30% of procedures. Since 2012, a multicenter RCT was published in NEJM, indomethacin use in~     high risk patients was considered a standard method to prevent PEP. The mechanism of~     indomethacin is dependent on COX-2 inhibitor.~      According to data, we design the project. The purpose of this study is to determine whether~     COX-2 inhibitor is effective on control of Post-ERCP pancreatitis.~   "
46028|NCT02964390|"~     Balloon pulmonary angioplasty (BPA) emerged as a potential therapeutic option for~     non-operable patients with chronic thromboembolic pulmonary hypertension (CTEPH).~      The aim of this study was to evaluate the safety and efficacy of BPA in patients disqualified~     from surgery or suffered from persistent CTEPH despite pulmonary endarterectomy.~      This is a interventional study analyzing the benefits and the risk of BPA. Clinical~     evaluation, including: functional capacity, 6-minutes walking test, haemodynamics,~     biomarkers, cardiopulmonary exercise test, echocardiography, electrocardiography and QoL~     assessment with Short Form 36 (SF36) questionnaire was performed before the initiation~     therapy of BPA, and 3-6 months after last session of BPA.~   "
46029|NCT02964377|"~     This single center open-label pilot study will enroll 15 non-ambulatory children with~     Duchenne muscular dystrophy at least 8 years of age and who demonstrate pre-clinical~     cardiomyopathy (defined as a cardiac ejection fraction >55% with abnormal LV strain by~     cardiac MRI). They will receive (+)-epicatechin at one of three doses during an 8-week~     dose-ranging study with assessments at baseline, 2 Weeks, 4weeks, and 8 weeks. The study will~     determine optimal dosing for future cardiac efficacy studies based on serum / plasma~     biomarker response using follistatin: myostatin ratio, nitrite/nitrate ratio, cardiac~     troponins and cardiac BNP. Secondary endpoints will include additional biomarker assessments~     by SOMAscanTM, cardiac functional evaluations by cardiac MRI (LV strain), and echocardiogram~     (LV strain by speckle tracking) and measures of strength, range of motion and mobility, and~     clinical safety assessments. Results of secondary endpoint analysis will be used to refine~     design of subsequent clinical trials powered to detect changes in clinical outcomes.~   "
46030|NCT02964364|"~     Takayasu arteritis (TA) is a chronic large-vessel vasculitis that mainly affects the aorta~     and its major branches. The epidemiology and pathophysiology of TA is still unclear in China,~     although many studies have been done. Our previous study supporting by National Natural~     Science Foundation of China indicated the cytokines such as hs-CRP, NT-proBNP and tumor~     necrosis factor-alpha (TNF-α) can be used to monitor TA activity, and HLA gene alleles were~     associated with TA in Chinese han population. Further investigations with larger samples are~     needed to fully understand the a pathophysiology of TA. The purpose of this study is to build~     a Chinese national registry system for TA to obtain real-world information, such as current~     status of characteristics, diagnosis, disease activity, the severity of disease, treatment~     and outcomes of Chinese TA patients. To analysis and development of effective disease~     monitoring and treatment strategies.~   "
46031|NCT02964351|"~     In our study, the investigators want to find correlation between circulating miRNAs~     associated with prostate cancer metastases to bones and to lymph nodes separately with~     results of 68Ga-PSMA ligand PET (positron emission computed) imaging.~   "
46032|NCT02964338|"~     The purpose of the current study is to evaluate the efficacy and safety of TEV-48125~     (Fremanezumab), in the prevention of CCH in adult patients.~   "
46033|NCT02964325|"~     This is a prospective, multi-center, controlled, randomized, non-inferiority study to~     evaluate the clinical effectiveness of Conventional versus Mirasol-treated apheresis~     platelets in subjects with hypoproliferative thrombocytopenia who are expected to have~     platelet count(s) ≤ 10,000/μL requiring ≥ 2 platelet transfusions.~   "
46034|NCT02964312|"~     To obtain outcomes data in subjects with severe to extreme class NOSE scores undergoing~     placement of the Spirox Latera Implant with or without concurrent turbinate reduction~     procedures in an office setting.~   "
46035|NCT02964299|"~     The purpose of this study is to compare the effect of mandibular advancement bite block to~     standard bite block for prevention of hypoxemia, intervention events and adverse effects~     during endoscopic examinations.~   "
46036|NCT02964286|"~     In this proposed project, the investigator will estimate the effect of massotherapy of~     acupoints on alleviating chemotherapy-induced myelosuppression among patients with cancer.~   "
46037|NCT02964273|"~     The primary objective of the study is to assess the long term safety of treatment with~     tolvaptan in children and adolescents with autosomal dominant polycystic kidney disease~     (ADPKD). The secondary objective is to assess the pharmacodynamics, pharmacokinetics, and~     efficacy of tolvaptan in the same subject population.~   "
46038|NCT02964260|"~     This study intends to evaluate the efficacy and safety of Transarterial embolization (TAE)~     simultaneously combined with thermal ablation for large hepatocellular carcinoma (HCC). Half~     participants will receive TAE simultaneously combined with thermal ablation and the other~     half receive TACE sequentially combined with thermal ablation, which is a conventional~     treatment for HCC patients.~   "
46039|NCT02964247|"~     The trial is conducted in Asia, Europe, North America and South America. The aim of the study~     is to compare the effect of liraglutide 1.8 mg/day versus placebo as add-on to an SGLT2~     inhibitor with or without metformin on glycaemic control in subjects with type 2 diabetes~     mellitus.~   "
46080|NCT02963714|"~     Intramuscular injection of 40 μg hepatitis B vaccine in a standard three-dose schedule or a~     four-dose schedule is recommended for hemodialysis patients. However, seroconversion rates~     are inadequate and persistence of immunity remains a challenge.~      This is a randomized, controlled trial. The study will evaluate the immunogenicity, immune~     persistence, and safety of 20 µg and 60 µg recombinant hepatitis B vaccine with three~     injections at months 0, 1, and 6 in hemodialysis patients.~   "
46040|NCT02964234|"~     The participatory-based project will quantify the 'added benefit' of an empowerment~     intervention relative to an education intervention for 150 Latinas on the following outcomes:~     women's adherence to breast cancer screening guidelines; women's psychosocial facilitators~     (self-efficacy, norms, support, and knowledge); and women's dissemination of breast health~     messages throughout their social network. The empowerment intervention will train Latinas in~     how to discuss breast health with their family and friends and volunteer in local breast~     health promotion programs. Academic, clinician, and community partners will work together~     throughout intervention development and evaluation.~   "
46041|NCT02964221|"~     Patients assume that cognitive performance rapidly returns to baseline after anesthesia and~     surgery. Several studies have shown that one week after major non-cardiac surgery about 27%~     of patients have postoperative cognitive dysfunction (POCD) and 10% of patients at 3 months.~     Very few studies have assessed the incidence of POCD beyond 3 months. POCD significantly~     reduces quality of life. Identifying risk factors for POCD is important because it is~     associated with prolonged hospital stay, loss of independence, and premature retirement.~     There is an urgent need to measure and document the level of cognitive change associated with~     surgery with an easy to use tool, both prior to admission and after discharge. This~     information can be used to plan appropriate care paths and to identify or test the efficacy~     of potential new treatments to alter the negative trajectory.~   "
46042|NCT02964208|"~     The AMPLATZER LAA Occluder is a transcatheter, self-expanding nitinol device intended for use~     in preventing thrombus embolization from the LAA. The purpose of this study is to compile~     real world outcome data on the use of AMPLATZER LAA Occluder in subjects with non-valvular~     atrial fibrillation (NVAF)~   "
46043|NCT02964195|"~     The purpose of the study is to evaluate the efficacy of Rifaximin in the treatment of~     cirrhotic gastroesophageal variceal bleeding.~   "
46044|NCT02964182|"~     The goal of this research study is to learn more about the effects of different nicotine~     levels in cigarettes and electronic cigarettes (e-cigarettes). E-cigarettes use water vapor~     to deliver nicotine.~      This is an investigational study.~      Up to 480 participants will be screened to take part in the study, but only about 160~     participants will be enrolled. All will take part at MD Anderson.~   "
46045|NCT02964169|"~     Supporting HIV positive women to delay or prevent an unwanted pregnancy may improve women's~     health through family planning choices, regular health reviews, and support. A cohort study~     that was done in Mbarara amongst HIV-infected women documented 50% of the enrolled women~     having no desire for a (another) child during the 4 years since ART initiation, 51% had a~     serodiscordant partner, with only 45% using effective contraceptive method. Key predictors of~     contraceptive use were family planning goals within the DYAD. One of the key predictors of~     effective contraceptive use was male partner involvement and CD4 count. The WHO recommends~     dual contraception (use of condoms and a hormonal or permanent method) to prevent both HIV~     transmission and unwanted pregnancies (WHO,2014).This prospective intervention study aims at~     providing information on whether continuous family planning accessibility and support has a~     measurable impact on pregnancy intentions and contraceptive usage among postpartum HIV~     positive mothers delivering at MRRH, SW Uganda.~   "
46046|NCT02964156|"~     50-90% of patients with RA reports foot problems and the metatarsophalangeal joints of the~     forefoot are most frequently afflicted. Studies shows that foot problems can influence~     negatively on the walking function, physical activity and quality of life. Different foot~     orthoses and insoles are used as an intervention. Studies find that different insoles do have~     effect on pain, but there are no or minor effect on walking ability. The literature reports a~     further need for research and indicates the importance of studies on the effects of~     cost-effective insoles for patients with RA.~      Custom-built insoles takes time and are often expensive, and many patients, especially women,~     do not wear them since they often do not fit the shoes they prefer to wear. In this study, a~     4-mm thin, flat insole of a malleable plastic material (CI-Core®) with synthetic textile~     material on the upper side is customized to provide support for the transverse and~     longitudinal arches of the foot to reduce pressure on painful joints. The insole is easily~     customized and ready for use the same day. The purpose of this study was to determine whether~     this insole can reduce foot pain and increase walking distance in patients with RA and~     forefoot pain.~      An experimental study was performed on patients with RA and forefoot pain in either one or~     both feet. The patients walked as fast as they could in 6 minutes (6MWT) with either insoles~     (situation A) and without insoles (situation B). The order of situation A and B was~     randomized, and the assessor was blinded for the order of the two situations. Both tests were~     conducted the same day. After each test round, the patient was asked to register pain in the~     foot and perceived exertion. A telephone interview was conducted one year after the effect~     study to examine whether the insoles were still being used.~   "
46047|NCT02964143|"~     Platelet-rich plasma (PRP) is an autologous product prepared from the patient's own blood,~     representing a powerful source of platelet-derived growth factors, particularly useful in the~     field of regenerative medicine. The active and sequential secretion of these growth factors~     induces different cell signaling cascades that activate angiogenesis, cell proliferation,~     cell differentiation, eventually leading to new matrix synthesis and tissue regeneration.~      The potential benefits from the use of PRP for the treatment of cartilage defects rely on a~     number of studies conducted in validated animal models or in vitro, demonstrating the ability~     of PRP to stimulate collagen production and proteoglycans synthesis, as well as the~     proliferation and differentiation of mesenchymal stem cells into chondrocytes. Additionally,~     an increasing number of clinical studies shows an improvement of symptoms, most especially~     pain, without any occurrence of serious adverse events.~      Hyaluronic acid (HA), as one of the major components of the synovial fluid surrounding the~     cartilage, assumes an important role in the viscoelastic properties of the articular~     cartilage, conferring its shock absorbing and lubricating functions.~      It was demonstrated that rheological properties of synovial fluid decrease with aging and in~     patients suffering from osteoarthritis. Nowadays, intra-articular injections of hyaluronic~     acid represent a well recommended therapeutic option to relieve osteoarthritic symptoms,~     conferring a mechanical action on joints structures, thus leading to reduced pain and~     improved joint function Based on these data, it seems reasonable to hypothesize that a~     combination of both PRP and hyaluronic acid could provide greater benefits compared to the~     administration of each product alone, as their effects on osteoarthritis improvement are~     based on different mechanisms of action. In fact, on one side PRP promotes cartilage~     regeneration, while on the other side the HA acts as 3-dimensional support mesh for PRP,~     providing optimal release of platelets growth factors, strengthening and extending in time~     the activity of PRP.~      Cellular MatrixTM is a CE-marked class III medical device manufactured by the Swiss company~     RegenLab SA. Cellular MatrixTM allows to prepare autologous PRP combined with a~     non-crosslinked hyaluronic acid in a safe, rapid manner and in a single step. The PRP/HA~     combination is intended to be injected intra-articularly, in order to relieve osteoarthritic~     symptoms and to improve joint mobility and function. Therefore, the PRP/HA combination might~     represent a novel therapeutic option for patient suffering from knee osteoarthritis.~      This study will evaluate whether the effects of a PRP/HA combination prepared with Cellular~     Matrix™, when injected intra-articularly for the treatment of mild to moderate knee~     osteoarthritis, are superior to those of a well-recognized hyaluronic acid treatment~     (Ostenil® Plus), on one hand, and to those of PRP alone, on the other hand.~   "
46048|NCT02964130|"~     This pilot study is part of a global project that aims to better define and understand~     features of FBSS/POPS post-operative persistent syndrome patients (shortened as FBSS in~     the following project). FBSS is the acronym for Failed Back Surgery Syndrome, which has been~     defined as a chronic condition resulting from spinal interventions. Despite anatomically~     successful spine surgery, a significant proportion of patients is experiencing chronic~     refractory back and leg pain. In a recent multicentre study conducted on more than 100~     refractory FBSS patients, (ESTIMET Study), the mean delay between pain occurrence and FBSS~     diagnosis was 5 years. Therefore, FBSS pattern and potential responder stratification might~     guide us to eventually develop a decision tool for identifying FBSS patients. Easing and~     helping diagnosis of FBSS should improve referral yield to specialists and accelerate patient~     flow through the care pathway. Hence, FBSS patients, who usually present a long standing~     history of pain, would have access to appropriate therapies earlier. This could lead to~     better outcomes. The aim of this multicentre, prospective study is to collect specific data~     that are not collected in routine in order to better define and understand the potential FBSS~     population and to accelerate the diagnostic and optimize the choice of appropriate treatment.~      A multidisciplinary approach through a pain management clinical network, as it has been~     structured in Poitiers, will ensure that an exhaustive characterization of FBSS patients and~     their care pathway will be collected. In addition, since the cooperation between orthopaedic~     and neuro spine surgeons is not a common relationship found all over Europe (as it is~     observed in Poitiers), this study also aims to better understand the development of~     interactions between physicians/professionals and the substantial advantage which would~     result from bridging this gap. The N3MT (NeuroMapping Tools) software developed in Poitiers~     to collect data and assess objectively pain surface and intensity changes, before/after any~     treatment, with quantitative measurements, will be used as the central key of this project.~   "
46049|NCT02964117|"~     Epidemiological investigations has suggested exposure to air pollution linked with~     respiratory disease, especially chronic obstructive pulmonary disease. However, the potential~     mechanisms of adverse effects remains scare. The present study will assess the association~     between air pollutants and respiratory related parameters to elucidate possible mechanisms.~   "
46050|NCT02964104|"~     This trial is conducted in Europe. The aim of the trial is to investigate the safety,~     tolerability, pharmacokinetics (the exposure of the trial drug in the body) and~     pharmacodynamics (the effect of the investigated drug on the body) of insulin 287 in subjects~     with type 2 diabetes.~   "
46051|NCT02964091|"~     The main purpose of the study is to evaluate the efficacy, safety and tolerability of a~     medication, ledipasvir/sofosbuvir (LDV/SOF), used to treat individuals with chronic hepatitis~     C virus (HCV) in Rwandan adults. A sub-cohort of participants will have limited laboratory~     monitoring to determine the minimum laboratory tests necessary.~   "
46052|NCT02964078|"~     The main purpose of this study is to evaluate the effects of the interleukin-2 given in~     combination with pembrolizumab.~      Interleukin-2 (IL-2) is also called aldesleukin, or Proleukin™.~      Pembrolizumab is also called Keytruda™, or anti-PD-1 antibody.~   "
46053|NCT02964065|"~     This study is a Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase Ⅲ Trial to~     evaluate the efficacy, safety and immunogenicity of a single dose of Live-Attenuated~     influenza Vaccine(LAIV) among healthy children and adolescents aged 3-17 years.~   "
46054|NCT02964052|"~     Use of intravenous (IV) thrombolysis and intra-arterial (IA) recanalization treatment has~     been rapidly increasing, However, despite of the treatment, recanalization rates are 22.6 -~     70% and only 30-50% of patients show meaningful clinical improvements. Mechanisms of futile~     recanalization may include 1) large ischemic core, 2) poor collateral, and 3) presence of~     comorbidity. In this regards, developing selection criteria using acute stroke imaging and~     comorbidity is warranted.~      Investigators will recruit the consecutive acute stroke patients who received IV thrombolysis~     and/or IA recanalization treatment. This study will perform with prospective design to~     develop CT-based clot, core and collateral scores and a comorbidity index for selecting~     stroke patients who are at high risks by the treatment. Investigators will firstly establish~     the CT-based scores and comorbidity index using a pre-existing cohort database. Using these~     CT-based and comorbidity index, Investigators will validate them in a multi-center~     prospectively cohort. In addition, Investigators will assess the cost-effectiveness of~     selecting patients based on the comorbidity index.~   "
46055|NCT02964039|"~     The purpose of this study is to determine whether a novel treadmill training intervention can~     improve the gait stabilization strategy used by individuals who have experienced a stroke.~   "
46056|NCT02964026|"~     The primary objective for this retrospective Electronic Health Record (EHR) analysis is to~     evaluate the clinical outcomes associated with the utilization of a pulmonary artery catheter~     (PAC), for monitoring purposes, within patients undergoing cardiac surgeries (isolated~     coronary artery bypass graft [CABG], valve, aortic surgery, multi-procedures, other complex~     nonvalvular procedures and heart transplants). The study will be conducted using~     prospectively collected hospital inpatient data over a duration of over 5 years (Jan. 1, 2010~     - June 30, 2015) using a large US electronic health database (Cerner HealthFacts; Kansas~     City, MO).~   "
46057|NCT02964013|"~     This is a safety, efficacy, and pharmacokinetics study of MK-7684 as monotherapy and in~     combination with pembrolizumab (MK-3475) in adults with metastatic solid tumors for which~     there is no available therapy that is expected to convey clinical benefit. Part A of this~     study is a dose escalation phase. Part B is a dose confirmation phase to estimate the~     recommended Phase 2 dose (RPTD) for MK-7684 monotherapy or in combination with pembrolizumab.~     The anti-tumor activity of MK-7684 when used as monotherapy and in combination with~     pembrolizumab in participants with advanced solid tumors will be evaluated in Part B in a~     non-randomized study design. Part B will also evaluate 2 doses of MK-7684 in combination with~     pembrolizumab in participants with programmed death 1 (PD-1) treatment naïve cancer using a~     1:1 randomized study design. The primary hypothesis is that MK-7684 administered as~     monotherapy or in combination with pembrolizumab is safe when administered at the RPTD.~   "
46058|NCT02964000|"~     Hypothesis: Use of high level vs low level cold laser treatments will reduce chronic pain and~     the need for PRN opioid-containing analgesic medications.~      Secondary Hypothesis: High level (vs low level) laser treatments will increase the patients~     level of physical activity and quality of sleep.~   "
46059|NCT02963987|"~     In this study, the investigators varied the portion size of all meals served during two 5-day~     periods. During one period, baseline amounts of all foods and beverages were served, and~     during the other, the portion size of all items was increased by 50%. The primary aim of the~     study is to determine the effect of varying the portion size of foods and beverages served~     over 5 days on energy intake in preschool children.~   "
46060|NCT02963974|"~     This feasibility study evaluates whether children with unilateral, moderate to profound~     sensorineural hearing loss experience an improvement in speech perception, hearing in noise,~     localization, and quality of life with a cochlear implant as compared to an unaided listening~     condition.~   "
46061|NCT02963961|"~     Postoperative delirium is a significant public health concern, affecting up to 70% of elderly~     patients presenting for surgery. Furthermore, postoperative delirium is associated with~     increased mortality, persistent cognitive decline, increased hospital length of stay, and~     elevated healthcare costs. Unfortunately, there is a lack of evidence-based strategies that~     consistently and effectively reduce the risk of delirium. In fact, although the American~     Geriatrics Society has released guidelines for the prevention of postoperative delirium, the~     evidence supporting many of the proposed preventive measures has been deemed low quality.~      Cognitive training exercises have been shown to improve cognitive function and functional~     status in community-dwelling elderly adults, and benefits may last for several months to~     years. Specifically, training exercises have led to improved performance in attention,~     short-term memory, and visuospatial processing; all of which are implicated as clinical~     features of delirium. Cognitive training has also strengthened connectivity in brain networks~     implicated in postoperative delirium. Thus, given these specific neurological benefits~     afforded, preoperative cognitive training may provide protection against the development of~     postoperative delirium. As such, the aim of this pilot study is to assess the feasibility of~     implementing a preoperative cognitive training program for surgical patients at high-risk for~     delirium and other associated complications.~   "
46062|NCT02963948|"~     This is a 4-phase study to implement the NIDA CDEs in primary care settings. Collecting and~     utilizing the CDEs in clinical practice requires a strategy for implementing screening to~     collect substance use information that populates the CDEs, and assisting primary care medical~     staff to offer appropriate interventions by providing clinical decision support (CDS) and a~     mechanism for making referrals to addiction treatment. Investigators aim to maximize the~     efficient adoption of screening, CDS, and treatment referrals by integrating all of these~     activities into the electronic health record (EHR).~      The study will be conducted at three sites, representing three large health systems. Each~     phase will include deliverables essential to move to the next phase, and an independent~     Advisory Committee will review progress and make recommendations at each transition about how~     best to progress to each subsequent phase. Based on progress during earlier phases, the~     Advisory Committee may recommend expansion to additional clinics or health systems during the~     second part of Phase 4.~   "
46063|NCT02963935|"~     This trial is conducted in the United States of America (USA). The purpose of the trial is to~     investigate the effect and safety of liraglutide 3.0 mg as an adjunct to intensive behaviour~     therapy for obesity in a non-specialist setting (IBT-CMS: Intensive Behaviour Therapy for~     obesity in a primary care setting according to Centers for Medicare & Medicaid Services (CMS)~     visit schedule).~   "
46064|NCT02963922|"~     This trial is conducted globally. The aim of this trial is to investigate effect and safety~     of liraglutide 3.0 mg in subjects with overweight or obesity and type 2 diabetes mellitus~     treated with basal insulin.~   "
46065|NCT02963909|"~     Phase 1 study to evaluate two doses of Alum Adjuvanted Zika Virus Purified Inactivated~     Vaccine (ZPIV) administered 28 days apart. The study will enroll 75 flavivirus naïve healthy~     adult subjects into 3 equal groups sequentially. Each group will include 20 ZPIV recipients~     and 5 placebo recipients. Group 1 will receive two ZPIV or placebo doses 28 days apart. Those~     in Group 1 who consent to a third ZPIV dose will receive 5.0 mcg dose of ZPIV or placebo~     administered IM on Day 224. Group 2 subjects will receive a two-dose regimen of IXIARO® 28~     days apart; two ZPIV or placebo doses three months later 28 days apart. Those in Group 2 who~     consent to a third ZPIV dose will receive it on Day 336. Group 3 subjects will receive one~     dose of YF-VAX® followed three months later by two ZPIV or placebo doses 28 days apart. Those~     in Group 3 who consent to a third ZPIV dose will receive it on Day 308. In each group, those~     who do not agree to receive the third ZPIV dose will be followed based on the schedule. The~     primary objectives are: 1) To evaluate the safety and reactogenicity of a two-dose homologous~     prime boost regimen of ZPIV among flavivirus-naïve, YF-VAX® primed, and IXIARO® primed~     subjects; 2) To evaluate the safety and reactogenicity of a third dose of ZPIV in consenting~     subjects.~   "
46066|NCT02963896|"~     Surgical removal of vestibular schwannoma causes acute vestibular symptoms, including~     postoperative vertigo and oscilopsia due to nystagmus. In general, the dominant symptom~     postoperatively is vertigo. Preoperative chemical vestibular ablation can reduce vestibular~     symptoms postoperatively.~   "
46067|NCT02963883|"~     Postoperative erythrocytes transfusion is associated with morbidity and excess mortality,~     which should lead to ask the indication for RBC transfusions only on metabolic needs.~     Currently, the majority of studies used to put hemoglobin values indicating red cell~     transfusions. Two observational studies have confirmed that a transfusion strategy based on a~     metabolic index (ScvO2) individual was accompanied by a different transfusion strategy than~     using the hemoglobin threshold values. We propose to conduct the first randomized multicenter~     study to evaluate erythrocyte transfusion strategy in postoperative cardiac surgery using the~     ScvO2 each patient versus a threshold value usually recommended for all patients.~   "
46081|NCT02963701|"~     Primary objective To demonstrate the bioequivalence of a fixed dose combination tablet~     containing 400 mg Ibuprofen and 60 mg Pseudoephedrine-HCl vs. RhinAdvil® (2 tablets~     containing 200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) as a fixed dose combination tablet~     with respect to the analytes, ibuprofen and pseudoephedrine.~      Secondary objective To assess the bioequivalence of a fixed dose combination tablet~     containing 400 mg Ibuprofen and 60 mg Pseudoephedrine-HCl vs. RhinAdvil® (2 tablets~     containing 200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) as a fixed dose combination tablet~     with respect to R- and S-ibuprofen (enantiomers of ibuprofen).~   "
46082|NCT02963688|"~     PURPOSE: To investigate the prevalence and clinical correlation of the germline BRCA 1/2~     mutation in Korean patients with high grade(HG) serous and/or endometrioid epithelial ovarian~     cancer (EOC).~      PATIENTS AND METHODS: In a nationwide case-control study on EOC conducted in Korea between~     2010 and 2015, 298 Korean women with HG serous and/or endometrioid EOC were tested for gBRCA~     1/2 mutation, regardless of the family history. Mutation screening was performed using the~     Ion AmpliSeq BRCA 1/2 Panel (Life Technologies, Carlsbad, CA, USA) and Ion PGM platform~     according to the manufacturer's instructions. Clinical characteristics including survival~     outcome was assessed in gBRCAm carriers.~   "
46068|NCT02963870|"~     The recommendation for the treatment of suicidal adolescents, Cognitive Behavioral Therapy~     (CBT) targeted new generation offer effective approaches to suicidal crisis and relapse~     prevention.~      Since 2009, our team is engaged in a partnership between France and Quebec Interuniversity~     agreement concluded by a University Picardie Jules Verne-University of Montreal. In this~     context, two teams G4 (Amiens and Rouen) have received training in suicidal crisis, including~     the security plan by a university instructor and TCC Québec, Dr. Labelle. Furthermore, we~     complete a descriptive and prospective study of risk and protective factors for adolescent~     suicide in which the Quebec team of Professor Labelle contributes as an expert (sponsor:~     Rouen). 200 subjects were recruited on 2 years by 3 (CHU Amiens, CH Compiègne, CHU Rouen)~     with an assessment of recurrence at 1 year (lost rates of view = 15%). The first results~     highlight the central role of personal coping strategies (coping) in suicidal recurrence. We~     want extend this study to validate the implementation of the security plan (safety level)~     with suicidal adolescents. The security plan is the initial step of the TCC approach short of~     suicidal crisis. It is established after working with adolescents and their families (chain~     analysis of the suicidal crisis, coping self-evaluation and identification of support~     resources). Developed by Stanley B from Columbia University and adapted for francophone~     adolescents R Labelle and JJ Breton wrote this list those resources and coping strategies to~     apply in case ideation and suicidal crisis. Signed by the young person and his family, he~     then uses to frame the monitoring and management plan of the youth and his family~     environment, friendly and professional in case of suicidal crisis.~   "
46069|NCT02963857|"~     This study evaluates the efficacy of the the pecto-intercostal fascial plane block (PIF~     block) for the anesthesia of the intercostal nerves anterior branches and assesses the~     association of the serratus block with a PIF block for the breast surgery.~   "
46070|NCT02963844|"~     Introduction: Obstructive sleep apnea (OSA) is characterized as a disorder that causes~     recurrent episodes of partial or complete obstruction of the upper airways during sleep.~     Objectives: In this way, the study will investigate the efficacy of inspiratory muscle~     training in improving the severity of obstructive sleep apnea and sleep quality of the~     research participants. Methods: The investigators will invite individuals of both sexes~     diagnosed with obstructive sleep apnea moderate and / or severe, arising from the Sleep~     Laboratory of the Hospital PROCAPE, located in Recife. This is a randomized-controlled trial,~     double-blind to be held in two groups: A) Individuals with OSA (moderate or severe) -~     Experimental Group: The components of this group hold the IMT with load of 75% of Pimáx. (~     assessed weekly) for eight weeks. B) Individuals with OSA (moderate or severe) -Group~     control: This group will simulate training, performing no-load training for the same period~     the intervention group. All guidance on training and weekly evaluations will be made by the~     responsible for the research physiotherapist in Cardiopulmonary Physiotherapy Laboratory~     (LACAP - UFPE). Before and after the eight weeks, the groups will be evaluated by~     polysomnography, acoustic pharyngometry, tests for respiratory muscle strength~     (Manovacuometry) and lung function (spirometry). Expected results: Improvement of severity of~     OSA and sleep quality of research subjects after the completion of eight weeks of TMI when~     compared to the control group.~   "
46071|NCT02963831|"~     This is a two-part Phase 1/2 dose escalation and dose expansion study of the GMCSFencoding~     adenovirus, ONCOS-102, in combination with anti-programmed death ligand-1 (PDL1) antibody,~     durvalumab, in adult subjects with peritoneal disease who have failed prior standard~     chemotherapy and have histologically confirmed platinum-resistant or refractory epithelial~     ovarian cancer or colorectal cancer.~   "
46072|NCT02963818|"~     Exploring technology based tools to reduce drinking is important. The purpose of this~     research study is to compare different BAC monitoring apps for their effects on alcohol~     drinking and ratings of usability among young adults.This study will be conducted in six~     phases: a web-based and in-person screening assessment; brief counseling session on the day~     before the alcohol drinking session; brief appointment on the day of the alcohol drinking~     session; alcohol drinking session; two-week field period; and a follow-up appointment.~     Participation in this study will last approximately two months.~   "
46073|NCT02963805|"~     The purpose of the A-CLASS project was to measure the effect of the 4 hour offer on~     children's physical activity, health and physical competence.~   "
46074|NCT02963792|"~     Due to their difficult and stressful work surgeons are under continuous physical and mental~     stress exposing them to increased risk for burnout and lack of professionalism. The present~     intervention focuses on providing time and a safe space to debrief and explore personal and~     group experiences and dilemmas, as well as acquire coping skills related to burnout,~     communication and professionalism.~   "
46075|NCT02963779|"~     This study is conducted to determine the side effects related to LY2775240 given orally to~     healthy participants. Blood tests will be done to check how much LY2775240 is absorbed into~     the bloodstream and how long the body takes to get rid of it. Each participant will enroll in~     either Part A or Part B of the study, which will last about 14 weeks and 8 weeks~     respectively, including screening.~   "
46076|NCT02963766|"~     The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics and~     pharmacodynamics of the study drug dulaglutide compared to placebo in pediatric participants~     with type 2 diabetes. The study duration is approximately 60 weeks.~   "
46077|NCT02963753|"~     Hyperemesis gravidarum (HEG) is not only nausea and vomiting of pregnancy, but it is also a~     clinical syndrome including endocrine and metabolic complications. Recently, some~     investigators have been begun performing researches related to the development of gestational~     diabetes mellitus (GDM) in pregnant women with HEG because they think about those metabolic~     and endocrine complications of HEG.In the literature there are few studies assessing how HEG~     has effects on GDM or 75 gram oral glucose tolerance test (OGTT). So the investigators aim to~     evaluate the effects of HEG on 75 gram OGTT.~   "
46078|NCT02963740|"~     The purpose of the study is to demonstrate that breast cancer survivors who need to lose~     weight are able to follow a weight loss program which combines modest calorie restriction~     with a graduated activity program..~   "
46079|NCT02963727|"~     Wharton Jelly derived Mesenchymal Stem Cells (WJMSC) will be injected in patients diagnosed~     with Knee osteoarthrosis~   "
46083|NCT02963675|"~     This study is conducted to obtain information about prostate cancer patients with bone~     metastases before the end of 2013. The incidence of second primary malignancies and overall~     survival in patients with castration resistant prostate cancer are of particular interest.~     Information from this study will serve as a historical reference for the REASSURE study~     (Background incidence study)~   "
46084|NCT02963662|"~     Obesity and type 2 diabetes, dyslipidemia and related metabolic disease has become a threat~     to our national life and health which is showing a trend. Bariatric Surgery had been~     confirmed definite therapeutic effect to obesity and type 2 diabetes. However, laparoscopic~     gastric bypass and laparoscopic sleeve gastrectomy have the similar outcome to type 2~     diabetes, but the two surgical methods and principles are completely different, which~     mechanisms are not yet clear. Lots of literature report adipose tissue releases adipokines~     and inflammatory cytokines induced chronic inflammation and obesity-related complications~     (insulin resistance and Type 2 diabetes).It is not clear whether to change these~     gastrointestinal hormones, adipokines and secretion of inflammatory cytokines with the~     operation, which play a therapeutic effect of obesity-related complications and diabetes. In~     addition, the investigators are wonder whether gut hormones, adipokines and inflammatory~     cytokines have some correlation in different severity obese patients,. It is worth to explore~     that could intestinal hormones, adipokines and inflammatory factors levels guide us to choice~     the different surgical approach to different severity obese patients. The investigators tried~     to investigate different surgical methods to alleviate diabetes and other metabolic diseases~     mechanisms though hormones and inflammatory factors and adipose tissue inflammation level and~     compare the impact of intestinal hormones and inflammatory adipokines of the two surgical~     approaches.~   "
46085|NCT02963649|"~     To assess the safety and efficacy of the paclitaxel drug-eluting balloon IN.PACT 014 versus~     conventional percutaneous transluminal angioplasty (PTA) for the treatment of patients with~     chronic total occlusions in the infrapopliteal arteries.~   "
46086|NCT02963636|"~     The project objective is to evaluate the impact of the recent addition of pharmacists within~     family medicine groups (FMGs) on organizational and clinical parameters. The process by which~     changes occur and the level of pharmacists' activities will also be assessed. The ultimate~     goal of the project is the development of an accompanying guide to facilitate the work of the~     pharmacist in monitoring complex patients in primary care medical clinics.~   "
46087|NCT02963623|"~     Retrospective study to evaluate if FIBTEM predicts the amount of postoperative bleeding in~     total knee replacement patients.~   "
46088|NCT02963610|"~     For the phase I component of the trial a classic 3 + 3 dose escalation design will be~     utilized, with a fixed dose of pembrolizumab and an escalating dose of the lenalidomide. The~     patient population will all have histologically confirmed advanced solid tumor malignancy.~     The primary endpoint for the phase I component of this protocol will be determining the~     maximum tolerated dose (MTD) of lenalidomide in combination with pembrolizumab.~      The phase II component of this trial will utilize a two stage design, initially enrolling 13~     patients, followed by 13 more patients if the early stopping criteria are not met. The target~     population will include patients with histologically confirmed diagnoses of non-small cell~     lung carcinoma, regardless of histologic subtype; who have completed one line of standard~     therapy. The primary endpoint for the phase II component of this protocol will be determining~     efficacy as measured by progression free survival (PFS)~   "
46089|NCT02963597|"~     The objective of the study is to evaluate the effect of continuous positive airway pressure~     (PAP) therapy on pulmonary arterial (PA) pressures in acute decompensated heart failure (HF)~     patients with obstructive sleep apnea (OSA). The study will also assess changes in functional~     parameters, biomarkers, and echocardiographic parameters.~   "
46090|NCT02963584|"~     The aim of this study is to assess the feasibility and validity of patient-level~     randomization (vs. cluster randomization) in pilot trials of decision aid efficacy.~   "
46091|NCT02963571|"~     To validate the safety and effectiveness of minimally invasive posterior percutaneous pedicle~     screw fixation in acute thoracolumbar vertebral fractures with simple anterior spinal column~     injury.~   "
46092|NCT02963558|"~     This proposal will test the hypothesis that EARLY application of a novel early rehabilitation~     therapy in critically ill patients will improve functional outcomes, and change the~     functional trajectory of this population. A pilot study of early mobilization with a cycle~     ergometer will be performed and translate into humans the pre-clinical mechanisms that may~     mediate the effects of early mobility.~   "
46093|NCT02963545|"~     Single-center, prospective, descriptive and biomedical research with controls, without health~     product.~      Depression is the second risk factor for stroke as tobacco smoking following hypertension.~     Peripheral abnormalities in serotonin parameters were described in depression and tobacco~     smoking. The investigators hypothesized dysregulations in pathways of serotonin (5-HT), which~     has notably complex vasomotor effects and of kynurenine which could have cognitive~     dysfunction effects.~      The aim of this study is to evaluate simultaneously the involvement of serotonin and~     kynurenine pathways parameters in patients suffering from a cerebral infarction shortly after~     the onset (less than 4 hours and a half), within a 2 days follow-up (Day 1 and Day 2) and 3~     months after the cerebral infarction.~   "
46103|NCT02963415|"~     The study will implement and test a unique Virtual Reality Cognitive Training (VRCT) combined~     with concurrent cycling on a recumbent stationary cycle, also known as exergame that~     seamlessly integrates specific cognitive tasks into a virtual environment and is synchronized~     with cycling to promote cognition.~   "
46104|NCT02963402|"~     We can speculate that the best responders to tocilizumab should have multiple related~     elements (Treg CD39, adenosine, IL-35) successfully induced and expressed in order to play~     its beneficial role. The study of these elements and its pathways could help identify the~     best responders to tocilizumab treatment.~   "
46105|NCT02963389|"~     This is an open-label, single ascending dose study to evaluate safety, tolerability, and~     pharmacokinetics/pharmacodynamics of Tripegfilgrastim in pediatric solid tumor/lymphoma~     patients~   "
46357|NCT02960087|"~     The purpose of this study is to evaluate the dose of High Dose Rate (HDR) brachytherapy~     chosen for this study as well as a commonly used alternate form of brachytherapy called low~     dose rate (or seed) brachytherapy. Investigators would like to understand how these~     treatments control the prostate cancer and look at their short and long term treatment~     related side effects.~   "
46094|NCT02963532|"~     The timing of extubation following surgery and anesthesia in young children is a complex~     decision frequently guided by the experience of the clinician. The clinician frequently must~     make a decision based on assimilating multiple cues that may or may not demonstrate that the~     patient is ready for extubation such as eye opening, conjugate gaze, spontaneous ventilation,~     and end tidal agent concentration. At this time there is no published data on the predictive~     ability of individual extubation criteria for young patients undergoing anesthesia for~     surgery so most practice is based solely on experience and anecdotal teaching. In some cases~     if the timing is misjudged and the patient is extubated too early negative airway reflexes~     such as breath holding and laryngospasm may take over creating a critical situation in which~     the patient forgoes gas exchange and rapidly desaturates with the potential for bradycardia~     and further cardiovascular collapse.~      Routine criteria used to determine fitness for extubation have been primarily described in~     the intensive care unit literature and may be less relevant in the operating room in the~     setting of routine general anesthetics. Most predictors including adequate tidal volume,~     presence of conjugate gaze, eye opening, patient movement purposeful or otherwise, low end~     tidal anesthetic agent concentration, response to physical or verbal stimulation and the~     laryngeal stimulation test have not previously been evaluated to determine their individual~     predictive value in deciding if the presently anesthetized patient now emerging is ready to~     be extubated.~      In order to perform a laryngeal stimulation test the patient must be breathing spontaneously~     and practitioner will gently move the endotracheal tube up and down stimulating the larynx.~     In patients in stage 2 of anesthesia, the clinician will typically observe a cough or series~     of coughs followed by a respiratory pause of greater than 5 seconds. In this situation the~     patient has not adequately passed through stage 2 and remains at increased risk for apnea,~     breath holding, or laryngospasm. If the patient is in stage 1 of anesthesia the clinician~     will observe a cough followed by a brief pause (less than 5 seconds) or almost immediate~     return to spontaneous ventilation.~      In conclusion, their exist no quantitative data on the predictive value of these various~     criteria for extubation and the goal of our study is determine the indivdual predictive value~     of different criteria in determing fitness for extubaion in young pediatric patients by~     recording the presence or absence of various criteria in pediatric patients at the time of~     extubation during routine anesthetic care.~   "
46095|NCT02963519|"~     Primary objective:~      Demonstrate that in patients with acute leg wounds with skin defect, VistaCare® accelerates~     the formation of a quality granulation tissue and reduces preparation time to a cover~     gesture.~      Secondary objectives:~        -  Evaluate the success of hedging gesture~        -  Assess the quality of the bud by colorimetry~        -  Assess tolerance~        -  Collect medical and economic data on the care of patients included~        -  Evaluate the quality of life of patients~        -  Assess patient comfort~        -  Evaluate the ease of use for the caregiver~   "
46096|NCT02963506|"~     This is a study to evaluate the efficacy and safety of different doses of bimekizumab in~     subjects with active Ankylosing Spondylitis (AS).~   "
46097|NCT02963493|"~     This study will evaluate melflufen in combination with dexamethasone in the treatment of~     relapsed refractory multiple myeloma in adult patients with disease refractory to~     pomalidomide and/or daratumumab. All patients in the study will be treated with melflufen on~     Day 1 and dexamethasone on Days 1, 8, 15 and 22 of each 28-day cycle.~   "
46098|NCT02963480|"~     Similar to poly-trauma, acute myocardial infarction, or stroke, the speed and appropriateness~     of therapy administered in the initial hours after severe sepsis develops are likely to~     influence outcome. However, the crux of matter is the early diagnosis lacking of high~     sensitive and specific test, in contrary to, for instance, the acute coronary syndrome, where~     the highly sensitive Troponin T is measured and increased values are fix component of the~     diagnosis and definition of acute myocardial infarction. Cardiac surgery can initiate a~     systemic inflammatory response syndrome (SIRS) induced by extrinsic and intrinsic factors,~     which are associated in the pathogenesis of postoperative complications. SIRS is closely~     related to sepsis, but in contrast sepsis is induced by infection. This strong inflammatory~     response induces malfunction of the peripheral circulation with increased lactate levels,~     pronounced fluid accumulation and increased need of vasopressors.~      The investigators want to assess the timing dynamic of release of IL-6 apart from established~     markers like CRP, leukocytes, PCT. Target of this is to estimate the time-scope and -advance~     of an IL-6 axis panel toward the measurement of standard inflammation parameters in~     inflammatory response to surgical trauma as a pre-figuration of non-infectious SIRS and to~     search for a eligible cut-off of IL-6.~   "
46099|NCT02963467|"~     Smoking is one of the world's leading health hazards. Besides being a major risk factor in~     the etiology of COPD and lung cancer, cigarette smoke is also a causative agent lung diseases~     characterized by bronchiolar and interstitial inflammation. However, the associated lung~     pathology of smoking is not only a risk in the development of lung diseases, but also widely~     recognized as a major risk factor associated with perioperative respiratory and~     cardiovascular complications. Apart from the long term effects of cigarette smoke, acute~     effects of the inhalation of cigarettes smoke may influence the course of lung pathology. The~     inhalation of smoke causes inflammation in the lung by inducing chemotaxis and activation of~     neutrophils and macrophages and induces oxidative stress. As the acute inflammatory response~     to smoke inhalation seems to be the underlying mechanism for chronic diseases of smokers,~     exploring the field of the acute pulmonary changes after exposure to cigarette smoke is~     highly relevant. One reason for acute hypoxia and injury during smoking might be a severe~     mismatch of ventilation and perfusion of the lung. Using the multiple inert gas elimination~     technique (MIGET), a distribution of ventilation-perfusion ratios in the lung can be~     calculated by analyzing data on the retention and excretion of six infused inert gases. A~     saline solution containing the gases is infused intravenously. When passing through the lung~     the gases are either eliminated from the blood or retained depending on their partition~     coefficient and local V/Q ratio. The concentrations of the gases are measured in the mixed~     venous blood or the mixed expired gas and the arterial blood allowing for the calculation of~     retention and excretion and the derivation of V/Q distribution. MIGET is the experimental~     gold standard to determine the Ventilation-Perfusion ratio of the lung. The aim of this study~     is to show the acute effect of smoking on ventilation/perfusion ratio distribution in the~     lung in otherwise healthy smokers.~   "
46100|NCT02963454|"~     To investigate changes in the concentration of glucose, lactate, pyruvate and glycerol in the~     extracellular fluid of the skeletal muscle following levosimendan administration in patients~     with septic shock.~   "
46101|NCT02963441|"~     Diabetes affects 29.1 million people or 9.3% of the population of the United States. Results~     of a study by the Eye Diseases Prevalence Research Group reveal that 40% of diabetes patients~     have some degree of diabetic retinopathy (DR) and that as many as 8% have severe,~     vision-threatening forms of DR. Early laser photocoagulation in high-risk proliferative~     diabetic retinopathy (PDR) has been shown to decrease the relative risk of vision loss by as~     much as 52%. Injections of anti-VEGF agents preserve and improve vision in people with PDR~     and/or diabetic macular edema. Despite effective treatment however, tens of thousands of~     people with diabetes are going blind each year largely because they don't undergo annual~     screening for retinopathy. Currently, only some 50%-60% of people with diabetes have a yearly~     eye exam and there may not be enough eye specialists to see the balance.~      To address the issue of patient compliance with diabetic retinopathy screening, IDx-DR was~     developed as an automated screening device designed to analyze fundus images for the presence~     of lesions and other disease features associated with diabetic retinopathy. This study has~     been designed to validate the safety and efficacy of the device at the frontlines of~     healthcare.~   "
46102|NCT02963428|"~     The study aims to improve obstetrical care by managing gestational weight gain (GWG) among~     high risk women in an effort to reduce maternal and fetal complications.~   "
46106|NCT02963376|"~     Stroke is the fifth leading cause of death in the United States and is the leading cause of~     long term disability. Distinct geographic disparities in stroke mortality, with highest rates~     in the southeast United States including Arkansas, are known as the stroke belt. There the~     average stroke mortality is ≈20% to 40% higher than the rest of the nation. Stroke is the~     leading cause of serious long-term disability. Between 2012 and 2030, disability and medical~     costs related to stroke are projected to triple, from $71.6 billion to $184.1 billion, with~     the majority of the projected increase in costs arising from those 65 to 79 years of age.~      There are two main forms of stroke, ischemic and hemorrhagic. An ischemic stroke occurs in~     85% of cases and is caused by cerebral vessel occlusion, obstructing blood flow to a portion~     of the brain. Currently, the only approved therapies for acute ischemic stroke are IV tissue~     plasminogen activator (tPA), a thrombolytic agent that clears the thrombus within the blood~     vessel, or intra-arterial catheter thrombectomy. Despite the availability of therapy, it~     reaches only approximately 7% of ischemic stroke victims in the United States5. Delay beyond~     the effective time window for therapy is a common reason for failure.~      To reduce the devastating impact of stroke on individuals and society, the investigators~     continue to seek ways to improve functional recovery and limit ischemic damage in stroke~     patients. The potential neuroprotective agent, dodecafluoropentane emulsion (DDFPe) has~     recently shown strong positive effects in pre-clinical animal models of acute ischemic~     stroke6-11. Other perfluorocarbons have been tested in humans as potential neuroprotectants~     and blood substitutes yet none have been successful.~   "
46107|NCT02963363|"~     The purpose of this study is to assess the feasibility of a home-based adapted physical~     activity during neoadjuvant chemotherapy for HER2+ breast cancer.~   "
46108|NCT02963350|"~     -  To provide access to BMN 190 to patients with CLN2 disease who cannot participate in a~          clinical trial.~        -  To collect additional information on the safety and tolerability of BMN 190~          administration in patients with CLN2 disease.~   "
46109|NCT02963337|"~     Remifentanil may be an ideal drug for labor analgesia due to its pharmacodynamic and~     pharmacokinetic profile. As compared to epidural analgesia, it demonstrated satisfactory for~     pain relief at the beginning of labour with a gradual elevation of pain scores as labour~     progresses. However, fast onset and limited time efficacy may render it useful in multiparous~     with a faster labor progression, thus even making it an alternative to single-shot spinal~     analgesia.~   "
46110|NCT02963324|"~     The present study assesses the pharmacokinetic profile of Ivermectin (IVM) in healthy human~     volunteers and aims to create a physiologically-based pharmacokinetic model. Planned~     indication is the prevention of malaria transmission.~   "
46111|NCT02963311|"~     The purpose of this study is to assess the safety, tolerability, and efficacy of ALN-PCSSC in~     participants with homozygous familial hypercholesterolemia.~   "
46112|NCT02963298|"~     Glutamate is known to be a mediator for apoptosis after brain hypoxia e.g. due to cardiac~     arrest. This pilot trial evaluates the possibility of elimination of Glutamate by CRRT after~     cardiac arrest.~   "
46113|NCT02963285|"~     The purpose of this study is to determine the optimal range of insertion depths for a~     nasopharyngeal probe in anesthetized pediatric patients as a function of age.~   "
46114|NCT02963272|"~     Heart failure (HF) is a severe disease, burdened with a poor prognosis (30% mortality at 2~     years, 30% of rehospitalization within 1 month). It is also a major cause of health burden~     representing between 1.5 and 2 billions euros per year in France. Approximately 75% of these~     costs are due to hospitalization.~      Besides physical examination and echocardiography, biology may help refine the diagnosis, but~     also could provide powerful prognostic parameters.~      This study aims to assess the value of ST2 in the management of patients admitted for HF to~     reduce readmission at one month.~   "
46115|NCT02963259|"~     This post-marketing evaluation has been designed to consistently investigate the subject's~     preference when switching from a Medtronic® constant voltage or constant current device to a~     St Jude Medical Infinity™ or St Jude Medical BrioTM constant current system. As electrodes~     will not be re-positioned, differences in subject's preference are to be explained by the~     difference in shape of the delivered pulse or waveform between the two systems.~   "
46116|NCT02963246|"~     Aim: To compare the effects of a specific application of Mindfulness vs. Treatment-asusual~     control group in patients with bowel disease. Design: randomized controlled trial. Setting:~     Outpatient setting. Population: patients who attended bimonthly check up.~   "
46117|NCT02963233|"~     The treatment of pediatric supracondylar humerus fractures is controversial, but despite the~     injury's high incidence there is a lack of high level evidence to guide operative versus~     non-operative decision making for displaced fractures with an intact posterior cortex~     (Gartland Type II). This study aims to prospectively compare clinical, functional, and~     radiographic outcomes between operatively and non-operatively treated patients using a~     prospective multi-centre cohort design.~   "
46118|NCT02963220|"~     The primary aim of this study is to pilot cognitive behavioral therapy (CBT-AR)for~     avoidant/restrictive food intake disorder (ARFID) in 10 youth with ARFID (ages 10-21y).~   "
46119|NCT02963207|"~     OBJECTIVE: Our study aimed to compare a recently-developed endoscopic classification with an~     established one for colorectal lesions in a randomised trial between 2013 and 2015.~   "
46120|NCT02963194|"~     To determine whether the neuropeptide oxytocin (OXT) influences self-processing by~     investigating whether it increases the endowment effect in relation to both self and others.~   "
46121|NCT02963181|"~     Neurogenic Orthostatic Hypotension (NOH) is clinically defined as a consistent drop in~     systolic blood pressure (SBP) ≥30mmHg upon standing from a seated or lying position. However,~     50% of NOH patients also have associated supine hypertension. It has been proposed that~     supine hypertension is the result of intact post-ganglionic sympathetic nerves and therefore~     due to residual sympathetic tone. Furthermore, research investigating the effects of~     melatonin shows blood pressure implication of this naturally secreted hormone. Specifically,~     melatonin has been investigated as a non-traditional anti-hypertensive agent for patients~     with essential and nocturnal hypertension. Central and peripheral mechanisms have been~     proposed to help explain how melatonin reduces blood pressures. Therefore, we aim to identify~     NOH patients as having either intact or denervated post-ganglionic sympathetic nerves,~     monitor the correlation to supine hypertension and subsequently investigate the effects of~     melatonin on blood pressure in these patients.~   "
46124|NCT02963142|"~     Severe community acquired pneumonia is common and associated with high mortality.~     Conventional microbiological diagnostics identify pathogens in approximately half of cases,~     which is inadequate for both clinical and epidemiological purposes. This study applies~     next-generation sequencing based metagenomic techniques to patients with extremely severe~     community acquired pneumonia, to investigate the microbiome of severe community acquired~     pneumonia and evaluate metagenomic approaches as diagnostic tools.~   "
46125|NCT02963129|"~     Compare the frequency of epistaxis and quality of life related to nasal bleeding in patients~     with HHT colonized with sataphylococo before and after being treated with mupirocin ointment.~   "
46126|NCT02963116|"~     This study is a randomized, open-label, 5-period, 5-treatment, single-dose, single-center,~     crossover study to estimate the effect of AZD5718 on the pharmacokinetics (PK) of~     rosuvastatin, and to assess the relative bioavailability of AZD5718 oral suspension vs~     AZD5718 immediate release (IR) Tablet Formulation and the Food Effect of AZD5718 in Healthy~     Volunteers. The study will be performed at a single study center.~   "
46127|NCT02963103|"~     The objective of this study is to observe and evaluate the change in renal function following~     conversion from cyclosporine-based immunosuppressive regimen to tacrolimus-based one.~   "
46128|NCT02963090|"~     This is a multi-institutional, randomized, open-label phase II study of pembrolizumab~     compared to topotecan, administered to patients with SCLC who have progressed or relapsed~     after first-line treatment with etoposide and platinum. Patients will be randomized in a 2:1~     fashion to receive pembrolizumab or topotecan. Participants in the topotecan arm that~     progress will be allowed to cross-over to the pembrolizumab arm.~   "
46129|NCT02963077|"~     The primary objectives of the study are to evaluate the safety, tolerability and~     pharmacokinetics of A4250 after single or multiple oral doses in healthy subjects. In~     addition, will evaluate A4250 in combination with cholestyramine.~   "
46130|NCT02963064|"~     This is a single-arm, open label, Phase 1 study to assess the safety and tolerability of~     CD34+CD90+ hematopoietic stem cell (HSC) allografts infused into patients with SCID who are~     conditioned for transplantation with AMG 191, an antibody that targets CD117 present on~     endogenous HSC. The target dose of CD34+CD90+ HSC will be >1 x 10^6 cells/kg and the optimal~     conditioning dose of AMG 191 will be determined during dose escalation.~   "
46131|NCT02963051|"~     The purpose of this study is to determine the safety and optimal dosing of intravenous copper~     chloride and disulfiram in men with metastatic castrate-resistant prostate cancer (CRPC).~     Eligible men will have neuroendocrine prostate cancer (NEPC), adenocarcinoma CRPC with~     non-liver/peritoneal metastases (lymph nodes, bone, or lung) or adenocarcinoma CRPC with~     liver and/or peritoneal metastases. Subjects will receive three doses of intravenous copper~     chloride and take disulfiram and oral copper gluconate until disease progression (up to two~     years). Subjects will also undergo a PET scan with radioactive copper 64 to measure the~     levels of copper in their tumor. The central hypotheses of this project are that (a) copper~     chloride and disulfiram are safe to give together and that (b) the combination of disulfiram~     with copper will have efficacy for both mCRPC and NEPC.~   "
46132|NCT02963038|"~     Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and~     efficacy in patients with B cell malignancy including lymphoma or leukemia.~   "
46133|NCT02963025|"~     One-lung ventilation (OLV) with resting of the contralateral lung may be required to allow or~     facilitate thoracic surgery. However, OLV can result in severe hypoxemia, requiring a~     mechanical ventilation approach that is able to maintain adequate gas exchange, while~     protecting the lungs against postoperative pulmonary complications (PPCs). During OLV, the~     use of lower tidal volumes is helpful to avoid over-distension, but can result in increased~     atelectasis and repetitive collapse-and-reopening of lung units, particularly at low levels~     of positive end-expiratory pressure (PEEP).~      Anesthesiologists inconsistently use PEEP and recruitment maneuvers (RM) in the hope that~     this may improve oxygenation and protect against PPC. Up to now, it is not known whether high~     levels of PEEP combined with RM are superior to lower PEEP without RM for protection against~     PPCs during OLV.~      Hypothesis: An intra-operative ventilation strategy using higher levels of PEEP and~     recruitment maneuvers, as compared to ventilation with lower levels of PEEP without~     recruitment maneuvers, prevents postoperative pulmonary complications in patients undergoing~     thoracic surgery under standardized one-lung ventilation.~   "
46134|NCT02963012|"~     A prospective trail. Pregnant women in the first trimester with positive BHCG and no~     visualization of gestational sac will be recruited.~      The correlation between endometrial pattern and ectopic pregnancy will be assessed.~   "
46135|NCT02962999|"~     Chronic obstructive pulmonary disease (COPD) patients often undergo thoracic surgery due to~     lung cancer and emphysematous changes. One lung ventilation (OLV) used in thoracic surgery~     aggravates hypoxia and hypercapnia increasing intrapulmonary shunt and dead space.Ketamine~     provide bronchodilation by inhibiting the reuptake of catecholamines in the circulation. It~     also serves relaxation of bronchial smooth muscle. Our aim in this study, effects of ketamine~     on arterial oxygenation, the shunt fraction and the lung mechanics in patients with COPD who~     administered OLV because of thoracic surgery. Thirty patients with COPD who undergo~     thoracotomy for lung lobectomy will be included in this study. Patients will be randomly~     divided to a control group (%0,9 saline- CG) or a keta (ketamine- KG) group. KG will be~     administered 1 mg/kg ketamine bolus, then 0,5 mg/kg/hour ketamine infusion after the~     induction, CG will be administered sline bolus, then saline infusion. Peak airway pressure~     (Ppeak), plato airway pressure (Pplato), static compliance, shunt fraction, PaO2/FiO2 and~     arteriel blood gas values (Pa02, PaC02) will be recorded before initiation of OLV and 30~     minutes intervals after initiation of OLV.To evaluate the postoperative pulmonary~     complications, Pa02, PaC02 in blood gas and Pa02/Fi02 values will be recorded 20 minute after~     arrival at postoperative care unit. Patients will be evaluated for pneumonia, atelectasis and~     acute lung injury at postoperative 72 h and findings will be recorded. 30 day mortality will~     be recorded.~   "
46147|NCT02962843|"~     The purpose of this study is to evaluate whether training teacher and staff in the Incredible~     Years (IY) Teacher Classroom Management (TCM) program reduce behavior problems and promote~     social competence in student aged 6-8 years (school) and in children aged 3-6 year~     (day-care). To examine group differences from baseline to 8-9 months after, a~     quasi-experimental control group design with pre- and post-measurements was used.~   "
46136|NCT02962986|"~     Hypotension is a very common complication of spinal anesthesia for cesarean delivery, and can~     have unwanted side effects on both mother and fetus if not treated promptly. Phenylephrine~     has been the drug of choice to treat this spinal-induced hypotension. Although phenylephrine~     is safe to use for this indication, it has been associated with reflex bradycardia and a~     reduction in cardiac output.~      Norepinephrine is a potent vasopressor used to treat hypotension in the critical care~     setting. Recent studies have looked at norepinephrine's use in the obstetric setting, and~     have shown that it can be used safely and also has favourable hemodynamic properties when~     compared to phenylephrine, with less bradycardia and less depression of cardiac output.~      The investigators recently conducted a study to determine the ED90 of norepinephrine, and now~     plan to compare bolus doses of phenylephrine to norepinephrine for treating hypotension~     following spinal anesthesia for cesarean section.~      The investigators hypothesize that norepinephrine, when given as a bolus to prevent post~     spinal hypotension, will result in around 70% relative decrease in the rate of bradycardia~     when compared to phenylephrine in patients undergoing elective cesarean delivery under spinal~     anesthesia.~   "
46137|NCT02962973|"~     The purpose of this clinical investigation is to evaluate the safety and performance of the~     Carmat Total Artificial Heart (TAH) in patients suffering from advanced heart failure and~     requiring biventricular support.~      Each subject receiving the Carmat TAH is followed to the primary and secondary endpoints at 6~     months, with a subsequent follow-up period extending to 2 years post implant.~      The results of the study will be used to support a CE mark application.~   "
46138|NCT02962960|"~     This study will be conducted to characterize pharmacokinetics, pharmacodynamics, safety, and~     tolerability of anifrolumab given via the subcutaneous (SC) route of administration in adult~     Systemic Lupus Erythematosus (SLE) subjects with a type I Interferon (IFN) test high result~     and active skin manifestations while receiving Standard of Care (SOC) treatment. In addition,~     the efficacy of anifrolumab on SLE skin manifestations will be characterized.~   "
46139|NCT02962947|"~     The effectiveness of propranolol in infantile hemangiomas, the apparent better response to~     propranolol in breast cancer and the use of propranolol in a proportion of patients who did~     not develop melanoma recurrence suggested to use this unselective β---blocker to test the~     study hypothesis. The investigators propose a randomized double---blind placebo---controlled~     clinical trial (RTC) to evaluate whether the treatment with propranolol 80 mgR/die reduce the~     risk of CMM recurrence and mortality. Patients with resected stage II/IIIA CMM will be~     recruited in various Centers in Italy. Participants will be randomly assigned to propranolol~     treatment or placebo (1:1 ratio), treated for at least 1 year and followed for 2 years.~     Recruitment will proceed simultaneously at the different Centers, and will be completed in 2~     years. The primary outcome of the entire trial will be, however, estimated by assessing a~     reduction in overall mortality at five years. The investigators will also evaluate general~     CMM recurrence and CMM specific mortality.~   "
46140|NCT02962934|"~     The purpose of this study is to try to find out how critically ill patients receiving the~     antibiotic, ceftolozane-tazobactam, process it in their body. Investigators would like to~     study if the antibiotic concentrations during a dose of this antibiotic reaches the right~     concentrations necessary to kill the bacteria that is causing the infection. The process by~     which a drug travels through the body in blood, how it is broken down and removed by the body~     is called pharmacokinetics (PK). We can measure the PK by taking blood samples at specific~     times after the antibiotic is given.~      Investigators would like to do the study in patients receiving dialysis and patients who are~     not receiving dialysis. This information about how the antibiotic is processed in the~     critically ill patient is unknown and it is important to know whether the doses doctors give~     patients to fight infection are adequate. If antibiotic concentrations are low in the blood,~     it gives the bacteria an opportunity to become resistant to the antibiotic which can lead to~     the antibiotic being less effective against bacteria potentially exposing future patients~     with infections to a limited range of effective antibiotics.~      Patients will be consented, and given the antibiotic as prescribed. Blood samples will be~     taken from the drip that is already in the patients arm just as the antibiotic starts, at 15~     and 45 minutes, at 1,2,3,4,5,6,7 and 8 hours. Patients who are on dialysis will have the~     blood samples taken from the dialysis machine before the blood reaches the dialysis filter~     (same blood samples as the non dialysis patients) and also bloods samples taken after the~     filter at 45 minutes, 2 and 6 hours. Dialysis patients will also have 5 separate samples of~     ultrafiltrate taken (approximately 10mls) - ultrafiltrate is the waste product of the~     dialysis process. The total amount of blood will be 40mls which is equal to about 2~     tablespoons. The dialysis patient will have 50mls of blood taken.Information about the~     patients ICU stay will also be recorded.~   "
46141|NCT02962921|"~     Our investigation studies the role of acute insulin administration on the diabetic heart, its~     corresponding effective blood-insulin level and the time-course applicability of insulin in a~     routine clinical setting.~      A case series of six male (48.1 ± 4.9 y/o) patients with controlled diabetes (HbA1c of 6.6 ±~     0.3%, disease duration of 14.4 ± 6.7 yr). Each subject was evaluated for glucose homeostatic,~     hemodynamic and echocardiographic systolic and diastolic parameters at baseline and following~     two successive insulin-load steps of a euglycemic hyperinsulinemic clamp study, each 2 h in~     duration. Results are presented as a mean ± SEM and analysed using the student's t-test.~   "
46142|NCT02962908|"~     FLU-v is a vaccine that aims to protect against a wide range of flu viruses. The purpose of~     this study is to measure the immune responses induced by FLU-v vaccine. This study will look~     at how safe FLU-v is when administered and how successful it is in preventing flu or reducing~     the severity of the flu symptoms.~      The study requires 222 healthy volunteers 18-60 years old. Participation in the study will~     take a maximum of 7 months and consists of 5 visits. During visit 1, subjects will be~     examined by a doctor to make sure they are eligible to enter the study. A 15ml blood sample~     (a tablespoon) will be taken to check general health followed by a general physical exam.~     Medical history and some personal information will be collected. Subjects that have received~     the traditional flu vaccine in the past 6 months, and those females who are pregnant or~     breastfeeding will not be allowed in the study. Subjects of childbearing age must agree to~     use effective contraceptive methods.~      At visit 2, subjects will be randomly allocated to one of the four treatment groups~     summarised below:~        -  Treatment 1: FLU-v (test vaccine) at the start of the study (Day 0) and then again 21~          days later~        -  Treatment 2: FLU-v (test vaccine) with an additional substance added [known as Montanide~          ISA 51] which improves the effect of the test vaccine. Injection will be given on Day 0~          and then Placebo (no test vaccine) alone 21 days later~        -  Treatment 3: Placebo (no test vaccine) injection on Day 0 and then 21 days later~        -  Treatment 4: Placebo (no test vaccine) with an additional substance added [known as~          Montanide ISA 51] on Day 0 and then Placebo (no test vaccine) alone 21 days later~          Treatment will be injected under the skin in the upper arm on day 0 (visit 2) and 21~          days later (visit 3). Blood samples will be taken before treatment (day 0), and on days~          42 (visit 4) and 180 (visit 5) to the immune responses induced by the vaccine.~      Subjects will be asked to complete a diary card to write down any side effects that they may~     experience after vaccination. Subjects will also be asked to complete another diary card to~     document any flu-like symptoms experienced between December 2016 and March 2017, this time is~     officially considered as the flu season. During this period, if the subject experiences~     flu-like symptoms, a collection of a nose and tonsil swab will be arranged by the study site~     to confirm whether they have the flu or not.~   "
46143|NCT02962895|"~     This study will determine the dose-response relationship of VAY736 for key efficacy and~     safety parameters~   "
46144|NCT02962882|"~     A Multi-Centre, Open, Non-controlled, Clinical Investigation to Evaluate the User~     Friendliness and Wear Time of Multi-layer Foam Dressings With Safetac® for Pressure Injury~     Prevention in the Intensive Care Unit~   "
46145|NCT02962869|"~     To evaluate the potential of a test material to produce a photoallergic response~   "
46146|NCT02962856|"~     To determine the phototoxic potential of a topically applied article in human subjects~   "
46149|NCT02962817|"~     Aim: The primary aim of this project is to identify the fear-avoidance beliefs and attitudes~     of primary care physicians and nurses towards the treatment of chronic nonspecific low back~     pain to subsequently develop a biopsychosocial educational tool using a web platform. The~     secondary aim of this project is to evaluate the effectiveness of this educational~     intervention about pain neurophysiology and fear-avoidance beliefs, using a web platform for~     primary care physicians and nurses.~      Methods: Exploratory sequential mixed method design. For the qualitative phase of this study,~     researchers will use personal semistructured interviews. For the quantitative phase the~     authors will use an experimental study design.~      Subjects: medical and nursing staff working in primary care centers in the city of Lleida,~     Spain.~      Expected outcomes: the authors expect to change and modify wrong beliefs and attitudes about~     chronic low back pain of physicians and nurses working in primary care settings, using a~     web-based educational tool with the additional result of increasing knowledge on pain~     neurophysiology and reducing fear-avoidance beliefs.~   "
46150|NCT02962804|"~     There are two primary aims in the study: 1) to determine the tolerability and feasibility of~     combination hypofractionated radiation therapy and PD-1 inhibition with nivolumab, and 2) to~     determine the ability of hypofractionated radiation therapy to enhance response rate from~     PD-1 inhibition versus PD-1 inhibition alone by comparing the observed response rate under~     the combination therapy with a previously reported response rate under inhibition alone.~   "
46151|NCT02962791|"~     Cardiac resynchronization therapy (CRT) is a recommended treatment for selected patients with~     symptomatic heart failure (HF). Although most treated patients show a benefit from CRT, a~     lack of response is observed for about 25-30% of them whatever the response criteria used~     either based on the clinical status (NYHA class, Packer clinical composite score) or on~     ventricular remodeling parameters assessed by echography (Left ventricle end of systole~     volume). This rate has remained remarkably stable since the therapy started and has motivated~     many studies to better understand the underlying physiopathology and the CRT action~     mechanisms.~      Among the various research axes to improve CRT response and responders rate, increasing the~     number of pacing sites in an attempt to better homogenize the cardiac mechanical activity has~     been evaluated. A configuration with two RV leads and one LV lead was tested acutely in three~     studies. In all cases, it demonstrated a significant improvement of cardiac performance~     whether assessed by echographic parameters or LV dp/dt measurements. Additionally feasibility~     of this approach for long term CRT delivery was demonstrated during a previous study. First~     results with triple-site ventricular stimulation are encouraging and its clinical efficacy~     should now be tested on a larger population in order to conclude on its interest for CRT~     candidates.~   "
46152|NCT02962778|"~     This study evaluates RAS peptides profiles in patients with treatment resistant arterial~     hypertension.~   "
46153|NCT02962765|"~     Prospective, multinational, non-interventional post-authorisation study to collect additional~     clinical data and to ensure consistency in the long-term between the outcome from~     pre-authorisation clinical studies (in 135 previously treated paediatric and adult patients)~     and routine clinical practice. Besides aspects such as general product safety and efficacy,~     there will be a focus on immunogenicity, particularly on inhibitor development. The diagnosis~     of FVIII inhibitor will be based on clinical observations and confirmed by FVIII inhibitor~     testing in the laboratory.~   "
46154|NCT02962752|"~     The current study uses a double-blind, placebo-controlled, randomised cross- over design to~     assess the pharmacodynamics of the platelet MAO-B inhibition, plasma prolactin levels and~     blood glucose levels after consumption of a single serve of 'Blackadder' blackcurrant juice.~   "
46155|NCT02962739|"~     Adherence to daily dosing is very important for how well Emtricitabine/Tenofovir Alafenamide~     (F/TAF) works for treatment of chronic human immunodeficiency virus (HIV), or prevention of~     HIV acquisition. Methods to measure medication adherence to Tenofovir disoproxil fumarate~     (tenofovir DF, TDF), a similar but different prodrug of tenofovir, have been developed but~     cannot be extrapolated to F-TAF. By measuring F-TAF (the drug) and metabolites in the blood~     cells and dried blood spots, the study plans to see if these results predict adherence to~     taking the drug. The goal of this study is to vary the amount of F-TAF dosing and see if the~     drug levels in dried blood spots (DBS) change in a predictable way. This study will mimic~     different levels of adherence (33%, 67%, and 100% of daily dosing) using directly observed~     therapy (DOT) to establish the relationship between F-TAF in dried blood spots and adherence.~     Investigators will also measure drug in hair clippings to see if hair or DBS are a better~     predictor of adherence.~   "
46156|NCT02962726|"~     The aim of this study is to evaluate the effect of starvation and recovery in adolescent~     anorexia nervosa patients in regard to microbiome activity and composition and to elucidate~     potential connections between weight gain, depression and other comorbidities, further to~     capture hormone levels and inflammation parameters in a longitudinal design.~   "
46157|NCT02962713|"~     Although the Atraumatic Restorative Treatment (ART) is well settled in the literature~     regarding occlusal-proximal cavities, the longevity of these restorations is still lower when~     compared to occlusal ones. This factor is often associated with low mechanical properties of~     glass ionomer cements (GIC). The objective of this randomized clinical trial is to evaluate~     the long-term cost-effectiveness of two different materials: an encapsulated GIC - Equia (GC~     Corp), compared with Giomer (Beautifill Bulk Restorative - Shofu) used as restoratives~     materials in occlusal-proximal ART restorations of primary molars. Children aged between 4~     and 6 years, will be selected in schools in the city of Barueri, São Paulo. All restorations~     will be held following the precepts of the ART and the manufacturer's instructions. The~     restorations will be evaluated after 6, 12 and 24 months according to Roeleveld et al. (2006)~     criteria. To verify the survival of the restorations will be used Kaplan-Meier survival~     analysis and log rank test. To evaluate the association between the clinical variables, Cox~     regression test will be applied. For the cost analysis will be used analysis of variance. The~     level of significance for all tests will be considered to 5%.~   "
46158|NCT02962700|"~     The aim of the study was to investigate whether CVVH, in comparison to intermittent~     haemodialysis (IHD), is able to improve regional perfusion in septic shock patients studied~     by muscle microdialysis~   "
46159|NCT02962687|"~     The purpose of this study is to examine the feasibility and acceptability of a 12-week care~     management program for medically complex Veterans with cognitive impairment, delivered via~     telephone or videoconferencing.~   "
46161|NCT02962661|"~     Any time the words you, your, I, or me appear, it is meant to apply to the potential~     participant.~      The goal of this clinical research study is to learn if adding mesenchymal stem cells (MSCs)~     to standard of care drugs can help control heart failure that may have been caused by~     anthracyclines. The safety of the MSCs will also be studied.~      MSCs are a type of stem cell that can be removed from bone marrow and grown into many~     different cell types that can be used to treat cancer and other diseases, such as heart~     failure. The MSCs used in this study were collected from healthy donors and are stored and~     grown in a lab at MD Anderson.~      This is an investigational study. MSCs are not FDA-approved or commercially available. They~     are being used for research purposes only. The study doctor can explain how they are designed~     to work.~      Up to 72 participants will be take part in this study. All will be enrolled at MD Anderson.~   "
46162|NCT02962648|"~     Evaluation of safety and efficacy of IV iron isomaltoside re-dosing.~   "
46163|NCT02962635|"~     A precise volume status assessment is critical to improve outcome of patients on dialysis.~     Yet, accurate assessment of fluid status remains a challenge. Currently, this is performed by~     clinical evaluation and regular weight measurements before and after dialysis, which is not~     always accurate. Moreover, bioimpedance technology is used in some centers for quantitative~     assessment of total body water. This approach has been validated for the assessment of volume~     status in dialysis patients, but requires the acquisition of specific tools and is time~     consuming. So far, no biomarker has been validated to quantify volume status in dialysis~     patients. Application of biomarkers might contribute to a better dialysis prescription and~     therefore to outcome improvement in dialysis. The investigators aim to investigate the role~     of a novel biomarkers (sCD146) to assess volume status in dialysis patients~   "
46164|NCT02962622|"~     The study evaluates the association between soluble insulin receptor dysfunction,~     cardiorespiratory fitness, and HIV associated neurocognitive disorder (HAND). Those who~     volunteer to participate in the study will have two evaluations at study entry that include a~     dual x-ray absorptiometry (DEXA) densitometry, anthropometry, neurocognitive testing, blood~     and urine samples for metabolic testing, and a cardiorespiratory fitness testing. DEXA will~     be conducted in the Endocrinology Unit at the University Hospital, Medical Center (letter of~     support included). The cardiorespiratory fitness testing will be conducted in the AIDS~     Clinical Trials Unit (ACTU) project, University of Puerto Rico, Medical Sciences Campus, and~     the Puerto Rico Clinical and Translational Research Consortium. Then, participants will be~     invited to participate in a 6-week, 3 days/week individualized exercise program. The exercise~     program will be conducted at the University of Puerto Rico Medical Sciences Campus. After~     completion of the exercise program, study entry evaluations will be repeated. The duration of~     the study will take approximately 10 weeks.~   "
46165|NCT02962609|"~     The purpose of this study is to determine the effect of Semielevated Side-Lying (ESL) and~     Semielevated Supine Position (ESU) positions used in bottle-feeding of very preterm infants~     upon their physiological characteristics and feeding performances.~   "
46166|NCT02962596|"~     This research is targeting patients with sonographically indeterminate adnexal mass that are~     being referred for clinical MR imaging. Investigators from the UW will be contributing coded~     MR images and associated health information (US results, laboratory/pathology results) to the~     EURAD trial. In addition, outcomes data on each patient will be sent at month 24 of the~     research.~   "
46167|NCT02962583|"~     Limited interventional human studies suggest that probiotic supplementation may be a~     beneficial strategy for promoting weight loss when added to a nutritional intervention via~     their effects on lipid absorption and metabolic signaling molecules. The purpose of this~     study is to evaluate the effects of addition of a probiotic supplementation to a weight loss~     intervention on body weight, body composition and overall health in overweight adults.~   "
46168|NCT02962570|"~     The main goal of this study is to determine if supplemental oxygen given only when the~     patient is inspiring (demand delivery) is more effective than constant-flow oxygen given~     during all phases of the breath regardless if the patient is breathing it in. A previous~     study in volunteers (NCT02886312) showed that the oxygen saturation in the blood and the~     concentration of oxygen breathed out from the lungs (end-tidal oxygen) was higher when given~     in demand (inhalation only) mode. A secondary goal is to determine in patients, whether~     turning oxygen delivery off during expiration improves the accuracy of end-tidal CO2 (Carbon~     Dioxide) monitoring. This was found to be the case in the previous volunteer study.~      The investigators want to determine if these improvements are also observable in relatively~     healthy patients undergoing procedural sedation and analgesia. The efficacy of the demand~     mode will be determined by measuring the resulting difference in oxygen saturation and~     end-tidal oxygen levels. The investigators will alternate between traditional oxygen delivery~     (continuous flow) and demand delivery (flow only during inhalation) for two minutes in each~     mode after which oxygen saturation and end-tidal oxygen will be measured. End-tidal CO2~     measurement will be compared with those during the brief time when O2 flow is stopped.~   "
46169|NCT02962557|"~     This study will explore the feasibility of an idea to use standard, FDA-approved patient~     monitors to detect ventilatory depression and then play a recorded nurse's voice to prompt~     patients by name to breathe. The voice prompt will occur in addition to when the traditional~     alarms are sounded by the monitors. The study device consists of commercially available~     physiologic monitors, a speaker, and a laptop computer. The physiologic monitors include a~     pulse oximeter with a motion sensor, capnometer, and nasal airway pressure sensor (built into~     a nasal cannula). Nasal pressure is a commonly used clinical monitor for sleep apnea~     detection during polysomnography testing in sleep labs.~   "
46170|NCT02962544|"~     Aim of the work is to compare the results of femtosecond assisted LASIK and small incision~     lenticule extraction (SMILE) as regards safety, efficacy and predictability. As a secondary~     outcomes , the investigators will compare the results of both techniques on corneal~     biomechanics, dry eye measures, corneal asphericity and higher order aberration.~   "
46171|NCT02962531|"~     An open-label, randomized, three-period, three-way crossover trial of single doses of IX-01~     in 12 healthy male subjects. In each period, subjects will receive a single oral dose of 1600~     mg IX-01, either as an aqueous dispersion in a fasted state, or as caplets in the fed or~     fasted state~   "
46172|NCT02962518|"~     Keloids are benign cutaneous lesions, arising from proliferating fibroblasts. Keloids of the~     ear may occur after helix piercings and are difficult to treat, since they tend to form~     recurrences. Guidelines suggest multimodal therapy, however, recurrence rates remain high and~     prospective randomized trials are still missing.~      To unravel the most effective combination of therapeutic options for keloids of the ear, 20~     patients will be enrolled in a prospective, randomized trial. Patients either undergo surgery~     using the fillet technique and intra-lesional injections of triamcinolone 10mg /ml every 4~     to 6 weeks for 6 months, or they are additionally treated with a non-customized pressure~     device.~   "
46173|NCT02962505|"~     The purpose of the study is to assess whether Electrical Impedance Tomography (EIT) has the~     potential to optimize the ventilator therapy, validate the effectiveness, efficacy and safety~     of nursing and medical interventions (endotracheal suctioning, posture changes, surfactant~     therapy, recruitment manoeuvres, etc.) and for early recognition of complications like~     pneumothorax and endotracheal tube misplacement. The study design is purely observational.~   "
46174|NCT02962492|"~     The study investigations include evaluation of the acute effects of a single dose of~     dapagliflozin (10mg), exenatide (5µg), a combination of exenatide and dapagliflozin or~     placebo under insulinopenic condition and the long term effect under basal conditions before~     and after 12 weeks treatment with dapagliflozin, Exenatide extended release, a combination of~     Exenatide extended release and dapagliflozin or placebo on ketogenesis, glucagon and~     lipolysis.~   "
46175|NCT02962479|"~     This study aims to compare biological communities in stool samples obtained from age, diet~     and BMI-matched subjects in five study groups: subjects with ankylosing spondylitis (AS)~     never treated with tumor necrosing factor (TNF) inhibitors, subjects with ankylosing~     spondylitis previously or currently treated with TNF inhibitors, subjects with~     non-radiographic axial spondyloarthritis (nrSpA) never treated with tumor necrosing factor~     (TNF) inhibitors, subjects with non-radiographic axial spondyloarthritis previously or~     currently treated with TNF inhibitors and healthy participants.~      The differences in fecal microbiota composition will be explored using shotgun metagenomic~     sequencing through the University of Washington. The investigators predict that this study~     will confirm a significant difference between the fecal microbiota composition (FMC) of both~     AS and nrSpA patients and controls.~   "
46176|NCT02962466|"~     Performing an additional non invasive oocyte diagnostic test based on cumulus gene expression~     could improve the outcome of the ART cycle.~   "
46177|NCT02962453|"~     The aim of this study is to determine the clinical efficacy of gait rehabilitation robot~     through cortico-spinal-muscular pathway activation of the muscles remotely located from the~     end-effecter in patients after total knee arthroplasty.~   "
46178|NCT02962440|"~     This trial is conducted in Europe. The aim of the trial is to investigate the absorption,~     metabolism and excretion of somapacitan after single subcutaneous dosing in healthy male~     subjects.~   "
46179|NCT02962427|"~     The purpose of this research study is to compare the effectiveness of a sphenopalatine~     ganglion block to an epidural blood patch for post-dural puncture headache relief in~     randomized postpartum parturients over a 48 hour period.~   "
46180|NCT02962414|"~     The purpose of this study is to evaluate the long-term safety in patients with TSC and~     refractory seizures who are currently receiving everolimus treatment in the~     Novartis-sponsored EXIST-3 study and who are determined to be benefiting from continued~     treatment as judged by the investigator at the completion of EXIST-3~   "
46181|NCT02962401|"~     Prospective national multicenter open label phase II Remodel WM3 trial~   "
46182|NCT02962388|"~     Prospective national multicenter randomized open label phase IIb RUXBETA trial.~   "
46183|NCT02962375|"~     Primary object is to determine if 100% orange juice with enzyme-treated orange pomace fiber~     compared to a 100% orange juice will reduce 2 hr glycemic response as measured by glucose~     area under the curve.~      Secondary object is to assess if 100% orange juice with enzyme-treated orange pomace fiber~     compared to a 100% orange juice will reduce 2 hr insulin iAUC response.~   "
46184|NCT02962362|"~     The purpose of this study is to collect patient outcomes data for patients who are undergoing~     an Exactech Optetrak® primary total knee replacement using the Exactech Guided Personalized~     Surgery (eGPS®) manufactured or distributed by (Exactech, Gainesville, Florida, USA). Patient~     outcomes data are important for assessing the post-market safety and effectiveness of~     orthopedic medical devices.~   "
46185|NCT02962336|"~     Subjects to compare the single dose bioavailability of Torrent's Olmesartan medoxomil,~     Amlodipine and Hydrochlorothiazide Tablets 40+10+25 mg and Tribenzor® 40+10+25 mg Tablets of~     Daichi Sankyo Inc, USA. Dosing periods of studies were separated by a washout period of 22~     days.~   "
46186|NCT02962323|"~     Subjects to compare the single dose bioavailability of Torrent's Rosuvastatin Calcium Tablets~     40 mg and Crestor® 40 mg Tablets of AstraZeneca Pharmaceuticals LP, USA. Dosing periods of~     studies were separated by a washout period of 7 days.~   "
46187|NCT02962310|"~     Subjects to compare the single dose bioavailability of Torrent's Rosuvastatin Calcium Tablets~     40 mg and Crestor® 40 mg Tablets of AstraZeneca Pharmaceuticals LP, USA. Dosing periods of~     studies were separated by a washout period of 7 days.~   "
46188|NCT02962297|"~     VENS is a multicenter, randomized, double-masked, placebo parallel controlled trial to~     evaluate the efficacy and safety of treatment with vitamin E softgel in non diabetic adults~     with NASH compared to treatment with placebo in China.~   "
46189|NCT02962284|"~     This is an open-label, single-arm, multi-center extension study to evaluate safety in~     patients with mCRPC of YONSA 500 mg (4 x 125 mg qd) with methylprednisolone (4 mg bid).~     Patients will have successfully completed an 84-day treatment with abiraterone acetate in a~     previous trial. Results from the final visit of the previous study will be used to determine~     patient's eligibility for this study. Patients in this study will be eligible to receive~     open-label YONSA with methylprednisolone for up to 12 months. Pharmacodynamic parameters of~     serum testosterone and PSA levels will be monitored. Disease progression will be assessed by~     PCWG2 criteria.~   "
46441|NCT02958995|"~     The purpose of this study was to evaluate whether treatment with pioglitazone is associated~     with risk of incident cancer at the 10 most common sites in a cohort of participants with~     recognized diabetes along with the assessment of association between diabetes severity and~     cancer risk.~   "
46190|NCT02962271|"~     Psoriatic arthritis(PsA) and psoriasis(Ps) are two systemic inflammatory diseases linked with~     rash of psoriasis, but there's still great controversy regarding the exact relationship~     between them. Our study is to investigate the characteristics and differences of the~     ultrasonic imaging of enthesopathy in the lower extremity in patients with PsA and Ps, to~     explore the risk factors of Ps developing into PsA in the long term course.~   "
46191|NCT02962258|"~     Subjects to compare the single dose bioavailability of Torrent's Olmesartan medoxomil,~     Amlodipine and Hydrochlorothiazide Tablets 40+10+25 mg and Tribenzor® 40+10+25 mg Tablets of~     Daichi Sankyo Inc, USA. Dosing periods of studies were separated by a washout period of 22~     days.~   "
46192|NCT02962245|"~     The research aim to find out whether berberine can reduce the annual recurrence rate of~     ulcerative colitis in remission.~      A total of 238 patients with ulcerative colitis in remission will be randomly divided into~     two groups.One will receive regular treatment,and the other group will receive extra oral~     berberine 300 mg three times daily for a year.~      The end of the study for every patient is disease recurrence(Mayo Clinic score of 3 points or~     more ).~      The primary analysis is annual recurrence rate, and both endoscopy and Mayo Clinic disease~     activity index scores at the baseline and final assessments.~   "
46193|NCT02962232|"~     To evaluate the safety and efficacy of the Paclitaxel Releasing Peripheral Balloon Dilatation~     Catheter (LEGFLOW) compared to the PTA catheter (AMPHIRION DEEP) in treatment of stenosis or~     occlusion in below the knee artery.~   "
46194|NCT02962219|"~     The purpose of this feasibility study is to determine whether a structured exercise programme~     prior to oesophagectomy has: acceptable adherence, is safe, and improves physiological~     measures of physical fitness above standard care.~   "
46195|NCT02962206|"~     Distal radius (Colle's) fractures in adult patients are commonly reduced in the emergency~     department before casting. Standard of care currently requires that x-rays be performed~     before and after fracture reduction, and inadequate reductions may be subject to repeat~     attempts and are at a higher risk to require surgery. This study will assess the use of~     point-of-care ultrasound (POCUS) in addition to standard care as a tool to decrease the~     angulation at the fracture site after a reduction is performed. If this angulation is~     decreased, it would suggest that POCUS for distal radius fracture reduction could decrease~     the number of failed reduction attempts and therefore the number of repeated reduction~     attempts.~   "
46196|NCT02962193|"~     After bariatric surgery there are big changes in the daily functions, activities and social~     participation of the patients.~      This is a prospective study that examine daily performance and daily participation by~     questionnaires, before and after bariatric surgery.~   "
46197|NCT02962180|"~     Actually the methods for melanocyte delivery are invasive and often sophisticated. The~     dermarolling system with needles causing tiny microinjuries in the epidermis could offer a~     minimally invasive and painless method of melanocyte transplantation. The purpose of the~     study is to develop a new and simple method for transepidermally delivering keratinocytes and~     melanocytes into vitiligo skin.~   "
46198|NCT02962167|"~     This is a two arm Phase I study within the Pacific Pediatric Neuro-Oncology Consortium~     (PNOC).~      This study will look to determine the safety and recommended phase 2 dose of the modified~     measles virus (MV-NIS) in children and young adults with recurrent medulloblastoma or~     atypical teratoid rhabdoid tumor (ATRT).~   "
46199|NCT02962154|"~     The purpose of project is to answer fundamental questions about the mechanisms underlying~     mental stress ischemia in patients with coronary artery disease, mood disorders, or both, and~     to identify potential biomarkers and psychosocial risk factors associated with this~     condition.~      To achieve this goal, investigators will use cutting-edge cardiovascular and functional~     neuroimaging tools to study mental stress ischemia in a carefully controlled laboratory~     setting in subjects recruited from four patient populations: 1) patients who recently~     sustained a myocardial infarction; 2) patients undergoing non-emergent invasive coronary~     angiography (with and without known coronary artery disease); 3) patients with a diagnosis of~     major depressive disorder; and 4) patients with a diagnosis of bipolar 1 or bipolar 2~     disorder.~   "
46200|NCT02962141|"~     To evaluate the safety and efficacy of Paclitaxel Eluting Hemodialysis Shunt Balloon~     Dilatation Catheter (APERTO) compared with the Balloon Dilatation catheter (OHICHO II) for~     the treatment of Arteriovenous Fistulae Stenosis in patients undergoing hemodialysis.~   "
46201|NCT02962128|"~     A randomized, clinical trial to provide the first comprehensive investigation of the role of~     fatty acid desaturate (FADS) genetic determinants on PUFA biosynthesis and metabolism as well~     as levels of inflammatory markers in a controlled dietary environment using two (low and high~     linoleic acid) parallel diets.~   "
46202|NCT02962115|"~     This study evaluates the feasibility of a clinical informatics system-based approach to lung~     cancer screening. Patients of a large academic medical center who may qualify for lung cancer~     screening will be sent an electronic invitation to complete an online lung cancer screening~     decision aid.~   "
46203|NCT02962102|"~     The purpose of this study is to assess the efficacy of calcifediol (25-hydroxyvitamin D) and~     calcitriol (1,25-dihydroxyvitamin D) in preventing and reducing the severity of acute kidney~     injury (AKI) in critically ill patients.~   "
46204|NCT02962089|"~     Oral supplementation with branched chain amino acids (BCAA) increases the levels of~     circulating BCAA, stimulates BCAA uptake in muscles, and decreases amino acid release from~     muscle, eventually promoting muscle anabolism. However, uptake of oral BCAA by muscle is not~     complete, pointing out that non-muscular tissues, as the splanchnic bed and gut microbiota,~     may play a role in BCAA metabolism.~      This protocol aims at studying the impact of protein-energy wasting (PEW) and of refeeding~     with branched chain amino acids (BCAA), on gut barrier including gut microbiota, in chronic~     hemodialysis (HD) patients. The investigators speculate that:~        1. HD patients with PEW have altered composition and function of gut microbiota, increased~          permeability of epithelial gut barrier, increased systemic inflammation but decreased~          fecal immunoglobulin A (IgA), and a dysbalance of plasma appetite mediators in favor of~          anorexigenic mediators, compared to HD patients without PEW, non dialyzed patients with~          chronic kidney disease and well-nourished non obese subjects,~        2. BCAA supplementation of HD patients with PEW reverses these changes, thereby improving~          nutritional state, physical function, quality of life and resistance to infections.~   "
46207|NCT02962050|"~     Individuals with Amyotrophic Lateral Sclerosis are at high risk for swallowing impairment~     (dysphagia) which leads to malnutrition, decreased pulmonary health, aspiration and~     aspiration pneumonia. These sequelae necessitate timely identification of at risk individuals~     to ensure optimal management of oral intake and pulmonary function. The purpose of this study~     is to evaluate the discriminant ability of several non-invasive screening tools at detecting~     swallowing impairment in individuals with ALS.~   "
46208|NCT02962037|"~     The purpose of this study is to determine whether the known treatment for DSPS also improve~     the cognitive ability and mood of the patients.~   "
46209|NCT02962024|"~     the investigators aim is to investigate and explore the effect 10 mg morphine added to local~     anesthetics in serratus anterior plane block for post mastectomy pain management after~     modified radical mastectomy in patients with breast cancer with assessment of its serum level~     if it will be absorbed systemically or not?~   "
46210|NCT02962011|"~     This was an unblinded randomized controlled trial. Women were randomized to uterine closure~     with the knotless barbed suture (Stratafix PDS, Ethicon) or Vicryl (Ethicon) at the time of~     elective cesarean. The primary outcome was closure time of the uterine incision. Also~     measured were blood loss during incision closure and the use of additional hemostatic~     sutures. Informed consent was obtained~   "
46211|NCT02961998|"~     Hepatocellular carcinoma (HCC) is a common fatal malignant tumor, although with the~     popularity of health examination, most patients were diagnosed as HCC in advanced stages so~     far. Sorafenib is currently recognized worldwide as the only effective treatment for advanced~     HCC. However, sorafenib need long-term medication, and will bring a series of side effects,~     including, hand, foot and comprehensive syndrome (Hand-foot syndrome, HFS) limbs swelling,~     rash, peeling, pain.Occurrence rate of HFS is about 21%-51%, which seriously affect patient's~     quality of life.Besides, this side effects appeared to be dose-related.When severe HFS~     happened, sorafenib need to reduce dosage or discontinue administration, which could~     seriously affect the patient's survival. Therefore, investigators designed this prospective~     randomized controlled study to explore preventive effect of celecoxib for sorafenib related~     HFS, the influence on the quality of life in patients with, and also the synergistic~     anti-tumor effect of celecoxib in combination with sorafenib on HCC. This study will explore~     horizon of improving treatment for sorafenib in patients with advanced HCC,quality of life~     and tumor control.~   "
46212|NCT02961985|"~     The Myocardial Infarction Register Saarland (MIR-SL), is intended to collect data about the~     treatment of patients suffering from ST-elevation myocardial infarction (STEMI). It aims to~     provide current data on the implementation of guidelines for both, the interventional and~     adjuvant drug therapy of STEMI in daily clinical practice in the Saarland.~   "
46213|NCT02961972|"~     The present study aims at investigating the effects of the oral supplementation with creatine~     on the systemic microvascular reactivity and plasma levels of homocysteine in vegetarian~     individuals of the vegan type.~   "
46214|NCT02961959|"~     Background: Pelvic pain is common during pregnancy and usually subsides after delivery. Some~     women, however, experience severe and long-standing pelvic pain, judged to emanate from the~     Sacro-iliac joints (SI-joints). Radiological correlates are absent and there are diverging~     opinions regarding the value of different clinical testing procedures and the use of~     anaesthetic blocks to reveal SI-joint origin of the pain. In case of slight or moderate pain~     the situation may be solved by the use of analgetics and physical therapy, but in case of~     severe pain the situation might end up in a discussion whether surgery with arthrodesis of~     the SI joint might be of value. To our knowledge, however, the results from surgical~     treatment has not been compared with non-surgical treatment in a randomized study.~      Aim: The investigators´ hypothesis is that~        1. there exists a specific identifiable subgroup of patients within the chronic low back~          pain (CLBP) group in whom the pain emanates from the sacro-iliac (SI) joints, and that~        2. patients in this subgroup may be selected based on thorough symptom analysis, and~        3. that arthrodesis of the actual joint/s may reduce the pelvic pain. Methods: A RCT with~          parallel group design with pre- and post-treatment data. Inclusion of women 18-55 years~          old with pronounced pelvic pain for at least 2 years and having tried ordinary physical~          therapy without improvement and being on sick leave at least 50 percent. Operation by~          posterior approach with bone transplantation between the iliac bone and the sacrum,~          using microsurgical technique. Patients in both groups, the surgical (S) and~          non-surgical (NS) were all treated by formal physiotherapy at a five days stay at the~          Clinic and instructed to continue their training at home according to the lines given at~          the Clinic.~      Outcome: The primary outcome was perceived pelvic pain according to the assessments on the~     validated Balanced Inventory for Spinal Disorders questionnaire (BIS) and on a Visual~     Analogue Scale (VAS) before treatment and at follow-up one year after treatment. The~     perceived change in pain was also assessed on a transitional scale in the follow-up version~     of the BIS.~      Secondary patient reported outcome measures (PROM) were pain related functions assessed on~     the Oswestry Disability Index questionnaire (ODI), the BIS and the Roland-Morris~     questionnaire. Health related quality of life was assessed by using the Short-Form 36 (SF-36)~     and Euro-Quol (EQ-5D) questionnaires.~   "
46215|NCT02961946|"~     To evaluate image quality of coronary CT angiography (cCTA) after sublingual and transdermal~     administration of Nitroglycerin. Aim of this prospective research study is to investigate~     equivalence on image quality after sublingual or transdermal Nitroglycerin administration~     (H0).~      Furthermore, the feasibility of transdermal Nitroglycerin administration will be evaluated.~   "
46216|NCT02961933|"~     This study will determine rates of first pass success without hypoxemia in emergency~     department intubations with and without the use of apneic oxygenation by nasal cannula.~   "
46217|NCT02961920|"~     The area of aesthesia-induced atelectasis is much larger in the obese compared with the~     non-obese, but there may also be more airway closure and impaired matching of ventilation and~     lung blood flow.~      When an anesthetized patient is turned to the prone position, dynamic compliance (Cdyn)~     decreases and peak airway pressure increases unless the abdomen hangs freely to prevent the~     abdominal viscera from compromising the diaphragm movement. Although the Wilson frame is~     designed to allow the abdomen to hang, it partially compresses the anterior abdominal wall~     and therefore does not allow the abdomen to hang completely, especially in obese patients.~      This in turn increases peak airway pressure and decreases Cdyn, oxygenation. This study aimed~     to investigate the effects of a prolonged I:E ratio (i.e., 1:1) compared with the~     conventional I:E ratio of 1:2 on respiratory mechanics and hemodynamics during spine surgery~     in the prone position in obese patients.~      We hypothesized that, compared with an I:E ratio of 1:2, a ratio of 1:1 improve oxygenation~     without hemodynamic instability .~   "
46242|NCT02961595|"~     Enterovirus infections may either increase or decrease the risk of type 1 diabetes depending~     on the age of infection and the type of enterovirus in question. This study evaluated whether~     early serial exposures to three replication-competent enterovirus strains (live poliovirus~     vaccine, OPV) can influence the immunity to other enteroviruses and the possible initiation~     of autoantibodies e.g. islet autoimmunity in young genetically predisposed children.~   "
46218|NCT02961907|"~     Infertility is defined as the inability to conceive after 12 months of unprotected~     intercourse, It affects approximately one in six couples pregnancy. Many lifestyle factors of~     the couple's pre and peri-conceptional environment (weight, diet, alcohol, tobacco, coffee,~     drugs, exercise, stress, sleep, pollution...) are risk factors for infertility. Weight gain,~     in both members of the couple, is associated with an increased risk of Assisted Reproduction~     Technology (ART) failure and adverse pregnancy outcome, while healthy lifestyle makes the~     risk of infertility three times less likely to happen. Idiopathic infertility may greatly~     benefit from lifestyle factors optimization.~   "
46219|NCT02961894|"~     To evaluate the safety and effectiveness of the Revolution™ Peripheral Atherectomy System in~     the treatment of infrainguinal lower extremity peripheral arterial occlusive disease.~      This Atherectomy system will be used on eligible patients with stenosis of at least 70%~     diameter reduction to evaluate the change in stenosis after the procedure (effectiveness) and~     the presence of any major adverse events (safety) for up to 30 days after the procedure.~   "
46220|NCT02961881|"~     Primary Objective:~      • To evaluate the safety and tolerability of every 12 hours (q12h) and every 24 hours (q24h)~     administration of subcutaneous (SC) blinatumomab~      Secondary Objectives:~        -  To determine pharmacokinetics (PK) with continuous intravenous (cIV) and SC~          administrations~        -  To estimate the maximum tolerated dose (MTD) tested for blinatumomab administered~          subcutaneously~        -  To determine the incidence of anti-blinatumomab antibody formation following SC~          administration~        -  To evaluate efficacy response following treatment with SC blinatumomab administration~      Exploratory Objective:~        -  To determine the pharmacodynamics (PD) time profiles for B-and T-lymphocytes as well as~          cytokine profiles during SC administration~        -  To evaluate efficacy response following treatment with SC blinatumomab administration~          using Lugano criteria~   "
46221|NCT02961868|"~     PROFILE is a cohort study evaluating the progression of fibromuscular dysplasia lesions. This~     study is the prospective dimension of ARCADIA registry (ClinicalTrials.gov Identifier:~     NCT02884141), which aims to document phenotypic and genetic traits in patients with renal~     and/or cervical artery fibromuscular dysplasia.~   "
46222|NCT02961855|"~     Double-blinded multicenter randomized clinical trial to evaluate the efficacy and safety of~     CLIFE2 (lidocaine, referred as treatment A) respect CLIFE1 (lidocaine plus diclofenac,~     referred as treatment B) in benign anorectal surgery.~   "
46223|NCT02961842|"~     The study will compare one technique of fluid administration (combined colloid preload and~     crystalloid colaod) with another one (crystalloid coload) during elective cesarean delivery~     performed under spinal anesthesia.~   "
46224|NCT02961829|"~     It is becoming clear that a combination of interventions will be desirable to achieve HIV~     cure. Therefore the investigators propose a pilot proof of concept study, using combination~     of a number of different interventions for eradicating residual plasma viremia and decreasing~     HIV reservoirs. The investigators hypothesize that, (i) antiretroviral intensification using~     Maraviroc, and/or dolutegravir with (ii) Dendritic Cell vaccination using autologous HIV, and~     (iii) purging intervention using the Class III HDACs, Sirtuin-1, and (iv) decreasing the~     ratio of long-lived central memory (TCM)/transitional memory (TTM) CD4+ T-cells using~     Auranofin will provide a synergistic impact leading to a sterilizing cure of HIV infection.~     Results of this study may provide insightful evidence for planning the next steps using the~     more efficacious combination of intervention strategies towards HIV sterilizing cure.~   "
46225|NCT02961816|"~     The goal of this clinical research study is to learn about the safety and effectiveness of~     the combination of panobinostat, gemcitabine, busulfan, and melphalan, either with or without~     rituximab, in patients who have non-Hodgkin's or Hodgkin's lymphoma and are receiving a stem~     cell transplant.~   "
46226|NCT02961803|"~     The primary objective of the trial is to demonstrate the superiority of biotin at 300 mg/day~     over placebo in the clinical improvement (walking tests) of patients with~     adrenomyeloneuropathy~   "
46227|NCT02961790|"~     This randomized phase III trial studies how well oxybutynin chloride works in managing hot~     flashes in patients who are not candidates for, or not interested in hormone replacement~     therapy. Previous studies have shown that oxybutynin is effective in managing hot flashes,~     however doses used in prior studies have resulted in side effects. This trial is evaluating~     lower doses of oxybutynin with the goal of determining if they are efficacious with less side~     effects.~   "
46228|NCT02961777|"~     Cardiovascular diseases, and more precisely patients with ST - elevated myocardial infarction~     are globally responsible for a large number of hospitalizations and deaths. Monitoring the~     quality of care for these patients is very relevant topic. Investigators developed indicators~     from the scientific literature on the quality of care for patients with STEMI at both the~     patient level and hospital level. The indicators were subsequently validated by a RAND~     modified Delphi - study of multidisciplinary experts in the care of patients with STEMI.~      In this study, the following objectives are set:~        1. ) Study of the quality of care for patients with STEMI in 16 Flemish hospitals with~          cardiology department by retrospective and prospective audit of 20 patient records per~          participating hospital .~        2. ) Study of the interdisciplinary relationships and communication within teams involved~          in the care of patients with STEMI in the participating hospitals 3) Study of perceived~          organization of care for patients with STEMI in the participating hospitals~      In accordance with the objectives of the research, the study consists of three phases:~        1. ) A retrospective observational audit of 20 patient records of patients with STEMI each~          participating hospital.~        2. ) A prospective observational audit of 20 patient records of patients with STEMI each~          participating hospital.~        3. ) A survey using validated instruments of interdisciplinary relationships and~          communication on the one hand and on the other by the teams involved in the care of~          patients with STEMI perceived organization of care .~      Data collection is performed by local researchers and remains their property. The data is~     coded and kept confidential. Only the local researcher has access to the encryption key. The~     data are protected by the Belgian law on privacy and medical confidentiality, only to be used~     in the context of this study. The results are published anonymously.~   "
46229|NCT02961764|"~     This study will evaluate a new critical pathway (use of guideline-based patient~     identification criteria and for those who meet these criteria, use of dalbavancin) for the~     treatment of ABSSSI compared to usual care.~   "
46230|NCT02961751|"~     Data from this clinical study will be used to assess if the treatment approach meets CDC~     criteria for becoming a recommended treatment (cure rate greater than 95 percent with a lower~     CI:95percent greater than 95 percent) or alternative treatment (cure rate greater than 95~     percent with a lower CI95 percent greater than 90 percent) for uncomplicated gonococcal~     infection. An estimated cure rate of 0.98. A single-arm clinical study design, allowing for a~     10 percent subject drop-out rate and 10 percent non-evaluable rate. Screening Visit will~     include a NG NAAT; the Baseline Visit at Day 1 will include a NG NAAT and culture; Test of~     Cure Visit at Day 6 will include a NG NAAT and culture. The primary objective of this study~     is to determine the efficacy of ciprofloxacin for treatment of uncomplicated N. gonorrhoeae~     infections with gyrA serine 91 genotype.~   "
46231|NCT02961738|"~     Narrative reformulation (NR) is an active ingredient of cognitive analytic therapy (CAT)~     which is assumed to increase engagement and improve outcomes. This trial sought to test these~     claims. A randomized and controlled dismantling trial method has been designed to investigate~     treatments outcomes for depressed patients receiving CAT in an Improving Access to~     Psychological Therapies service. Participants will be randomized to either treatment as usual~     (full-CAT) or CAT minus narrative reformulation (CAT-NR). The primary outcome measure is the~     Patient Health Questionnaire (PHQ-9), with secondary outcome measures of anxiety,~     functioning, helpfulness and the alliance. Outcomes will be assessed at screening, every~     treatment session and at 8-weeks follow-up. The trial will enable as assessment of the~     utility of NR during CAT. and whether CAT appears suitable for treating depression in Primary~     Care.~   "
46232|NCT02961725|"~     Bronchopleural fistula (BF), an abnormal passage or communication between a bronchus and~     another part of the body, may develop when there are penetrating wounds of the thorax and~     after lung surgery. Without effective therapy, treatment of BF is a challenge, with a high~     rate of mortality and teratogenicity.~      The investigators will conduct endoscopic injection of umbilical cord mesenchymal stem cells~     to fistula, observe the recovery of bronchopleural fistula and systemic reactions, to~     investigate the application of umbilical cord mesenchymal stem cells in the treatment of~     bronchopleural fistula.~   "
46233|NCT02961712|"~     HTLV-1 Associated Myelopathy is a chronic disease of the spinal cord, caused by a virus~     called human T lymphotropic virus type 1（HTLV−1）. Natural Killer cells provide rapid~     responses to viral-infected cells, acting at around 3 days after infection, and respond to~     tumor formation. In this trial, the investigators aim to study the therapeutic safety and the~     effect on HTLV-1 virus. This in turn will improve the knowledge and understanding of the~     disease and should lead to better therapy.~   "
46234|NCT02961699|"~     This is a prospective, randomized, single-site, safety and efficacy study of subjects with~     chronic venous stasis ulcers. Patients will fall into two categories: treatment arm (24~     subjects) and non-treatment or control arm (12 subjects). The treatment group will undergo a~     small liposuction procedure and receive placement of autologous cell therapy (stromal~     vascular fraction or SVF) injected around the rim of venous stasis wound~     (subcutaneously)following standard wound debridement, with saturation of collagen dressing~     material with standard over-dressing. Control (non-treatment) subjects will receive~     debridement and dressing changes as per standard of care without SVF.~   "
46235|NCT02961686|"~     The trial is to describe quality of life in patients affected by prostate cancer treated with~     exclusive radiotherapy and submitted to psychological and andrologic evaluation.~   "
46236|NCT02961673|"~     A Phase I/Ⅱ Clinical Trial to Compare the Safety and Efficacy of HU-014 versus Botox® in~     Subject with Moderate to Severe Glabellar Lines~   "
46237|NCT02961660|"~     The main purpose of this study is to evaluate the pharmacokinetics (PK) of a single oral dose~     of odalasvir (ODV) in participants with severe renal impairment and compare with the PK in~     matched participants with normal renal function.~   "
46238|NCT02961647|"~     The preferred treatment of organic mitral regurgitation (MR) is mitral valve repair.~     Optimally this should be timed so late that it commensurate with the risk of surgery and~     before irreversibly damage of the heart and pulmonary vessels. The aim is to obtain an~     understanding of the differences between the symptomatic and asymptomatic patient.~      The study will test~      A: Symptomatic organic MR is characterized by higher filling pressure, and higher stroke work~     during physical strain compared with asymptomatic MR.~      B: The extent of myocardial fibrosis is associated with filling pressure and cardiac index 1~     year after mitral valve repair.~      C: Filling pressure can be estimated non-invasively by echocardiography. To test this 40~     patients with asymptomatic MR and 40 symptomatic will undergo a stress echocardiography with~     simultaneous echocardiography and invasive measurement of central hemodynamics. In addition a~     pulmonary function test and cardiac MRI will be performed.~   "
46239|NCT02961634|"~     Single-center study, single blind, comparative with the objective of evaluating the efficacy~     and safety of an investigational product as an adjunct in the treatment of onychomycosis~     improvement of 90 days ± 2 days.~   "
46240|NCT02961621|"~     Emergency call centers across the country are preparing for the Next Generation 911 (NG911)~     initiative, which will allow citizens to place 9-1-1 calls using digital technologies such~     as text messaging, email, Skype or instant messaging, and will expand emergency information~     sources to also include streaming video, photo uploads, and automatic crash notifications.~     The impact of these new information and communication technologies on those tasked with using~     them in time-sensitive emergency situations is unknown. Our study is designed to address the~     following hypotheses: 1) We hypothesize that NG911 implementation will have a significant~     effect on telecommunicator stress levels and 2) A resiliency training tailored to the needs~     of telecommunicators will mitigate the impact on NG911 implementation on stress levels. We~     will test these hypotheses through the following specific aims:~      Aim 1: Measure levels of stress, job satisfaction and job performance among 9-1-1~     telecommunicators before and after the NG911 implementation.~      Aim 2: Develop and test the efficacy of an evidence-based resiliency training and worker~     support intervention to improve psychological well-being and job performance of 9-1-1~     telecommunicators.~      Aim 3: Build an ABM tool of 9-1-1 call centers to improve 9-1-1 telecommunicator workforce~     training and smooth transitions to future call center innovations.~   "
46241|NCT02961608|"~     LCP-Tacro is an extended-release formulation of tacrolimus designed for once-daily dosing.~     Phase 1 studies demonstrated greater bioavailability than twice-daily tacrolimus capsules and~     no new safety concerns.~        -  Stable kidney transplant patients can be safely converted from Adoport® twice-daily to~          LCP-Tacro®.~        -  The greater bioavailability of LCP-Tacro after once-daily dosing results in similar~          (AUC) exposure, at a dose approximately 30% less, than the total daily dose of Adoport®.~        -  LCP-Tacro provides a slow drug release and this results in flatter kinetics~          characterized by significantly lower peak-trough fluctuations.~        -  CN is the major cellular target of the calcineurin inhibitors (CNIs) cyclosporine A~          (CsA) and tacrolimus. The ability of these drugs to inhibit CN activity is dependent on~          their binding to the respective immunophilins, cyclophilins A and B for CsA and FKBP12~          for tacrolimus.~        -  CN inhibition is a rate limiting phenomenon. Over concentrations of tacrolimus does not~          correlate with an increase in the CN activity.~   "
46243|NCT02961582|"~     Rationale: Previous reviews showed that the evidence regarding the effectiveness of sacral~     neuromodulation (SNM) in patients with therapy-resistant, idiopathic (slow-transit)~     constipation is of suboptimal quality. Furthermore, there is no estimate of costs and~     cost-effectiveness in this patient group.~      Objective: The main objective of this study is to assess the effectiveness of SNM compared to~     personalized conservative treatment (PCT), in patients with idiopathic slow-transit~     constipation who are refractory to conservative treatment. The secondary objectives are~     assessing the 1) costs, 2) cost-effectiveness and 3) budget-impact of SNM compared to PCT.~      Hypothesis: Based on previous research we hypothesize that SNM will be more effective than~     PCT in terms of a significantly higher proportion of patients having treatment success at 6~     months.~      Study design: An open-label pragmatic randomized controlled trial (RCT) combined with a~     prospective cohort study.~      Study population: Adolescent (14-17 years) and adult (18-80 years) patients with idiopathic~     slow-transit constipation refractory to conservative treatment.~      Intervention: The intervention is SNM, a minimally invasive surgical procedure consisting of~     two phases. In the screening phase an electrode is inserted near the third sacral nerve and~     connected to an external stimulator. If the screening phase is successful (average defecation~     frequency (DF) ≥3 a week), the electrode is connected to a pacemaker that is implanted in the~     buttocks of the patient. If not successful, patients receive conservative treatment. The~     control intervention is PCT. This is the best and least invasive alternative to SNM. PCT~     consists of medication and/or retrograde colonic irrigation.~      Main study parameters/endpoints: The primary outcome is success at 6 months, defined as an~     average DF of ≥3 a week according to a 3-week defecation diary. Secondary outcomes are~     straining, sense of incomplete evacuation, constipation severity, fatigue, constipation~     specific and generic (health-related) quality of life ((HR)QOL), and costs at 6 months.~     Furthermore, cost-effectiveness and budget-impact will be estimated.~   "
46244|NCT02961569|"~     Tuberculosis (TB) is a major cause of death among the communicable diseases in the world.~     Pulmonary TB, the main localization, leads to the dissemination of cases. An earlier~     diagnosis of contagious pulmonary TB is a cornerstone to stop the air transmission. The aim~     of the study will be to compare two strategies, in patients with a chest-X-ray in favour of~     contagious pulmonary TB: the classical strategy of sputa collection during three consecutive~     early mornings, versus the studied strategy of sputa collection at hour h, hour h+1, hour h+2~     during the first early morning.~   "
46245|NCT02961556|"~     This baseline-controlled, open-label, multicenter study evaluates the efficacy and safety of~     AJG555 orally administered for 2 weeks in pediatric participants with chronic constipation.~     The safety and efficacy of 12 weeks of administration will also be evaluated.~   "
46246|NCT02961543|"~     A randomized clinical trial involving 30 individuals submitted to ACL reconstruction will be~     conducted.~      Participants will be randomized into: Group I, submitted to a muscular rehabilitation program~     based on eccentric isokinetic exercise; and Group II, submitted to a muscular rehabilitation~     program based on eccentric isotonic exercise. Concomitantly with the muscular rehabilitation~     protocols, individuals will undergo the same physiotherapeutic protocol with analgesia, edema~     reduction, range of motion, proprioception and functionality goals. Muscle rehabilitation~     programs based on eccentric isotonic and isokinetic exercise will begin 45 days after ACL~     reconstruction. The programs will last six weeks, with training frequency of two sessions per~     week, separated by a minimum interval of 72 hours.~   "
46247|NCT02961530|"~     A randomized clinical trial involving 32 individuals submitted to partial menisectomy will be~     conducted.~      Participants will be randomized into: Group I, submitted to a muscular rehabilitation program~     based on eccentric isokinetic exercise; and Group II, submitted to a muscular rehabilitation~     program based on eccentric isotonic exercise. Concomitantly with the muscular rehabilitation~     protocols, individuals will undergo the same physiotherapeutic protocol with analgesia, edema~     reduction, range of motion, proprioception and functionality goals. Muscle rehabilitation~     programs based on eccentric isotonic and isokinetic exercise will begin 15 days after partial~     menisectomy. The programs will last six weeks, with training frequency of two sessions per~     week, separated by a minimum interval of 72 hours.~   "
46248|NCT02961517|"~     Questionnaire study to investigate the effect of individual characteristics such as age, sex,~     ethnicity, educational level and socioeconomic status on the preferred format of patient~     education delivery, for patients with diabetes and/or cardiovascular disease~   "
46249|NCT02961504|"~     The primary objectives of this study is to evaluate the efficacy of HLCM051 on functional~     outcome in subjects with acute ischemic stroke and to evaluate the safety of HLCM051 in~     subjects with acute ischemic stroke.~   "
46250|NCT02961491|"~     The purpose of this sub-study is to provide expanded access of AZEDRA (Ultratrace Iobenguane~     I 131) and to evaluate the safety and tolerability of AZEDRA in subjects with iobenguane-avid~     malignant and/or recurrent pheochromocytoma/paraganglioma (PPGL).~   "
46251|NCT02961478|"~     IOXSOR study's purpose to determine the frequency of non resolutive renal failure (estimated~     by the clearance of iohexol) at end of stay in ICU patients who have had acute renal failure~     episode.~   "
46252|NCT02961465|"~     Rationale: Previous reviews showed that the evidence regarding the effectiveness of sacral~     neuromodulation (SNM) in patients with therapy-resistant, idiopathic (slow-transit)~     constipation is of suboptimal quality. Furthermore, there is no estimate of costs and~     cost-effectiveness in this patient group.~      Study design: A prospective cohort study with one group. This study is conducted next to a~     randomized controlled clinical trial (RCT) on 'the effectiveness and cost-effectiveness of~     sacral neuromodulation in patients with idiopathic slow-transit constipation refractory to~     conservative treatments' (for more information ClinicalTrial.gov ID: NCT02961582). This RCT~     is part of a temporary reimbursement arrangement, called conditional reimbursement of health~     care (in Dutch: Voorwaardelijke Toelating) of the National Health Care Institute~     (Zorginstituut Nederland). As part of this arrangement, the Ministry of Health, Welfare and~     Sports requires that SNM remains available for eligible patients during the conditional~     reimbursement period, also when inclusion of the RCT has ended. Furthermore, the Ministry~     requires that patients who received personalized conservative treatment in the RCT (control~     group), are offered SNM after completion of their follow-up of 6 months. As a result, the~     National Health Care Institute requires that the patients who receive SNM outside the RCT are~     included in a prospective cohort study to be able to collect data on them.~      Aim: The aim of this prospective cohort study is to collect more (but uncontrolled)~     information regarding the safety and effectiveness of SNM.~      Study population: Adolescent (14-17 years) and adult (18-80 years) patients with idiopathic~     slow-transit constipation refractory to conservative treatment.~      Intervention: The intervention is SNM, a minimally invasive surgical procedure consisting of~     two phases. In the screening phase an electrode is inserted near the third sacral nerve and~     connected to an external stimulator. If the screening phase is successful (average defecation~     frequency (DF) ≥3 a week), the electrode is connected to a pacemaker that is implanted in the~     buttocks of the patient. If not successful, the pacemaker will be removed and patients~     receive conservative treatment.~      Main study parameters/endpoints: The primary outcome is treatment success at 6 months,~     defined as an average DF of ≥3 a week according to a 3-week defecation diary and safety.~     Secondary outcomes are straining, sense of incomplete evacuation, constipation severity and~     generic (health-related) quality of life ((HR)QOL).~   "
46266|NCT02961283|"~     The study is divided into two parts. The first part of the study will test various doses of~     ASN003 to find out the highest safe dose to test in three specific groups.~      The second part of the study will test how well ASN003 can control cancer. Subjects will be~     enrolled into one of three groups.~      Group 1: metastatic or recurrent melanoma with documented BRAFV600 mutation (n=20 evaluable~     patients) Group 2: metastatic colorectal cancer (CRC), or advanced non-small cell lung cancer~     (NSCLC) with documented BRAFV600 mutation (n=14 evaluable patients) Group 3: advanced solid~     tumors with documented PI3K pathway alterations (PIK3CA mutation or PTEN loss) (n=14~     evaluable patients)~   "
46253|NCT02961452|"~     Peanut allergy (PA) has been well studied and its prevalence was estimated up to 1.3% in~     Europe. Tree nut (TN) allergy and PA are clinically similar and often coexist, TN allergy~     prevalence ranged from 0.05 to 4.9 %. TN allergy is longlasting and nearly all TN have been~     associated with fatal allergic reactions . Other legumes or TN also contain seed storage~     protein orthologs of the globulins (Ara h1, Ara h 3) and 2S albumins (Ara h 2) of peanut,~     susceptible to provoke allergic reactions, but cross-reactivity to TN and other legumes in PA~     patients could also appear through primarily sensitization. These possible IgE-binding~     cross-reactions bring to recommend the avoidance of TN and other legumes which have never~     been eaten in PA children. In this context, diagnosis work-up of relevant cross-allergy~     versus asymptomatic cross-sensitization will impact directly children's health-related~     quality of life (HRQL).~      When physicians suspect food allergy, many parameters have to be considered, such as clinical~     background, clinical history, type of symptoms related to the suspected food and~     cross-allergy to other foods. Then, to objectively confirm a food allergy and to assess its~     severity (related to the threshold reactive dose and symptoms), an oral food challenge (OFC)~     is demanded, and double-blind placebo-controlled food challenge (DBPCFC) is considered as~     the gold standard.~      Although OFC are more and more available in the diagnosis of PA, the assessment of~     cross-allergy to every single allergenic TN and legumes requires full allergy work-up and~     often many years of follow-up. Few studies investigated cross-allergy to TN and other legume,~     with rates of cross-allergy to TN between 28% and 50%. However, targeting patients with~     severe or cross-allergic phenotypes would greatly assist the allergist in management and~     follow-up of PA patients (i.e., planning OFC to cross-reactive food).~      Our main objective is to identify different disease phenotypes of PA children with cluster~     analysis. This statistical approach has never been performed to identify cross-allergic~     phenotypes. We also will describe cross-allergy in PA and will identify possible risk factors~     for cross-allergy to TN and other legumes in PA children.~   "
46254|NCT02961439|"~     The use of echocardiography in intensive care is a developing field. In expert hands~     echocardiography has proven its utility in diagnosing cardiac pathology, differentiating~     shock states and in haemodynamic monitoring. However, whether the results obtained by experts~     can be generalized to trainees or specialists with limited training remains unclear. Further,~     concerns around training time and cost for intensive care staff have been a factor in~     limiting the uptake of echocardiography in intensive care.~      The investigators aim to assess the diagnostic accuracy of Australian ICU doctors in training~     after completion of the current minimum training. After completing a structured teaching~     program and 30 mentored training scans trainees will be assessed on their accuracy with~     echocardiography. In the research phase trainees will complete a further 40 scans with each~     one matched with an expect scan. The results from the expert and trainee scans will be~     compared to determine the trainee's accuracy.~   "
46255|NCT02961426|"~     This is a Phase II/III, multicenter, multi-country, trial to assess the efficacy, safety,~     tolerance, and pharmacokinetics of sofosbuvir plus ravidasvir for the treatment of HCV~     infection.~   "
46256|NCT02961413|"~     This is a multi-center, prospective, non-interventional cohort study .~      Its primary objectives are:~        1. assess DILI patients' clinical characteristics, disease progression and influencing~          factors in clinical practice;~        2. learn about suspected drug caused DILI,rechallenging, liver biochemical abnormalities~          mode, etc.~   "
46257|NCT02961400|"~     A drop off in improvement over the months and years after treatment is common. One~     contributor may be poor memory for the contents of treatment. This study seeks to determine~     whether text messages containing reminders of the content of sessions will improve treatment~     outcomes.~   "
46258|NCT02961387|"~     Investigators aim to study the effectiveness and safety of inhaling hydrogen-oxygen which~     produced by a hydrogen generator with nebulizer to decreases inspiratory effort for the~     patients with tracheal stenosis.~   "
46259|NCT02961374|"~     This phase II trial studies the side effects of erlotinib hydrochloride and how well it works~     in reducing duodenal polyp burden in patients with familial adenomatous polyposis at risk of~     developing colon cancer. Erlotinib hydrochloride may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth.~   "
46260|NCT02961361|"~     Dexmedetomidine is an α-2 adrenoreceptor agonist and has been extensively used through~     intravenous infusion，in order to improved the quality of block in regional anesthesia. In~     this prospective, randomized study, the authors focus on the effect of dexmedetomidine mixed~     with ropivacaine in coracoid approach brachial plexus block.~   "
46261|NCT02961348|"~     This study will compare early with late start of treatment with Non-vitamin K oral~     anticoagulation (NOAC) in adult patients with acute ischemic stroke and atrial fibrillation;~     it is a registry-based randomized clinical trial (R-RCT) using The Swedish Stroke Register~     (Riksstroke). Half of the patients will start NOAC early (within 4 days after stroke onset)~     while the other half will start late (5-10 days after stroke onset).~   "
46262|NCT02961335|"~     Diffuse parenchymal lung diseases (DPLD) include a variety of respiratory conditions that~     affect either the pulmonary interstitium or the alveolar space . The etiological diagnosis of~     DPLD is often challenging, because of the large number of pathological entities involved,~     which share close clinical and radiological presentations. High resolution Chest CT, a key~     diagnostic procedure in DPLD, is subject to significant inter-observer analysis variations,~     so that the diagnosis sometimes requires a surgical or transbronchial lung biopsy sampling.~     This invasive procedure is not devoid of morbidity and may be impossible to perform in~     fragile patients. Therefore, the definite diagnosis of DPLD is usually achieved following a~     multi-disciplinary expert consensus, based on careful medical history, chest CT and~     bronchoalveolar lavage examinations.~      Alveolar probe-based confocal laser endomicroscopy (pCLE) is a mini invasive endoscopic~     technique that allows distal lung microscopic imaging in vivo, during a flexible bronchoscopy~     performed under topical anaesthesia. Since 2006, Alveolar pCLE has been used in a monocentric~     clinical trial at the Rouen University Hospital in more than 200 patients and healthy~     volunteers. This allowed the first pCLE in-vivo description of normal pulmonary acinus, and~     confirmed the safety of the technique.~   "
46263|NCT02961322|"~     This is a study of health economics longitudinal cohort on the evaluation of direct medical~     cost of a surgical technique based on the use of an innovative device (the da Vinci® surgical~     robot Si) and its comprehensive care.~   "
46264|NCT02961309|"~     The objective of the proposed research is to investigate how smoking increasing potency of~     THC (i.e., the psychoactive ingredient in marijuana) changes tobacco cigarette smoking~     behavior, urges, subjective effects, and abuse liability. This study will be a~     within-subjects, placebo-controlled study in our clinical laboratory of the effect of active~     vs. placebo marijuana on cigarette puff topography, exhaled carbon monoxide, urge, subjective~     effects, and abuse liability among 7 adults who smoke both marijuana and tobacco cigarettes.~   "
46265|NCT02961296|"~     The purpose of this study is to make nationwide registry for antimicrobial resistance of~     Helicobacter pylori using single method with agar dilution in Korea.~   "
46270|NCT02961231|"~     The cost of pneumococcal conjugate vaccine use can be greatly reduced by making use of~     existing herd immunity to protect children against vaccine type pneumococci. The~     investigators will reduce the circulation of vaccine type pneumococci to low levels by PCV~     catch-up campaign; vaccinating all children less than 3 years of age with PCV, after which~     the investigators will evaluate the ability of a simplified two doses regimen and an~     alternative one dose regimen to prevent the reintroduction of vaccine type pneumococci~     compared to the WHO recommended 2 doses schedule.~   "
46271|NCT02961218|"~     To determine the effect of canakinumab versus placebo on daily pain experienced by sickle~     cell anemia patients (Reduction of average daily pain VAS over the period of Week 8 to 12 as~     compared to baseline levels).~   "
46272|NCT02961205|"~     This randomized controlled pilot study evaluates the use of oral nutritional supplementation~     in nutritionally at-risk cardiovascular surgery patients. The oral nutrition supplement is~     given for 30 days prior to surgery, continuing throughout their surgical hospitalization and~     ends at hospital discharge. Half of the participants will receive the oral nutritional~     supplement and the other half will not.~   "
46273|NCT02961192|"~     In this study, we will conduct a one-year, four-arm, randomized, controlled trial to compare~     three social incentive-based gamification interventions to control for promoting physical~     activity and weight loss toward improved glycemic control among type 2 diabetics.~   "
46274|NCT02961179|"~     This study will investigate the in-depth the benefits of dairy consumption on glucose~     metabolism in patients at risk of type 2 diabetes using novel genomics methodology.To do so,~     33 individuals at risk of type 2 diabetes will be randomly subjected to an intervention study~     including a 6-week intensive dairy product consumption period and a 6-week dietary~     counselling period.~   "
46275|NCT02961166|"~     57 patients with Adult Respiratory Distress Syndrome (ARDS) requiring Extracorporeal membrane~     oxygenation (ECMO) therapy were analyzed retrospectively. 28 patients had received~     immunglobulin M-enriched immunoglobulin therapy (IVIG); 29 patients did not receive IVIG~     therapy.~      These patients were analyzed regarding length of stay in intensive care unit (LOS ICU),~     length of stay (LOS) in hospital and regarding mortality.~   "
46276|NCT02961153|"~     With the development of national economy and medical technology, patients can extend life~     rely on high-end medical facilities. At the same time, the continued treatment cannot bring~     benefits to children, even resulting in poor quality of life of children and bringing high~     medical costs. This makes the limited medical resources are unreasonable distributed.~     Research showed that PICU mortality rate halved over ten years ago, but the data did not~     include death cases who left hospital before death. However, the death number of out-hospital~     were more than death in-hospital. Therefore, the data cannot actually reflect China's~     mortality rate of PICU. The reason analysis was limited to the cause of the disease, and does~     not take the social, economic factors into account. This study include eight PICUs of~     children's Hospital PICU. Critically ill patients are prospectively studied from death risk~     factors, admission status, disease diagnosis, severity of illness, analyzing of the risk~     factors of death from disease diagnosis and death risk factors. In addition, we will~     illuminate the relationship of death and economic factor, especially for who died~     out-hospital after withdraw or stop treatment.~   "
46277|NCT02961140|"~     Anesthetic management and fluid therapy is crucial in esophageal resection and~     reconstruction, which is associated with high incidence of postoperative morbidity and~     mortality. This study aims to investigate the effect of goal directed fluid management on the~     postoperative outcome of esophageal resection and reconstruction.~   "
46278|NCT02961127|"~     The cases were hospitalized patients from two medical centers in Beijing and Harbin~     respectively. Venous blood was collected by standard vein puncture in fasting condition.~   "
46279|NCT02961114|"~     Benign prostate hypertrophy (BPH) and inflammation are common non-cancerous enlargement of~     the prostate, which result in urinary interference and incomplete drainage of the bladder.~     Compression of the urethra is common cause of such resistance of full draining, and may over~     time result in progressive hypertrophy, instability, urgency, nocturia and weakness of the~     bladder musculature.~      Prostatic growth frequently begins in the 30s, and it is estimated that 50% of all males have~     benign enlargement leading to 75% by age 80. BPH and low grade inflammation is one of the ten~     most prominent and costly disorders in males over 50.~      Urinary tract symptoms are divided into issues of storage, voiding, and post-void symptoms~     can be associated with bladder outlet obstruction (BOO).~      This study utilizes isolation of adipose-derived stem/stromal cellular stromal vascular~     fraction (AD-cSVF) deployed as an IV suspension in sterile Normal Saline (500cc). Due to the~     anti-inflammatory and immunomodulatory effects common to AD-cSVF are tested in relief of the~     inflammatory elements and the concurrent hypertrophy in BPH. Early pilot use has suggested a~     positive effect on these issues, and have relieved much of the incomplete voiding, pain,~     nocturia, delay in starting/stopping urination, and increased urgency and frequency.~      Lipoharvesting of Adipose-Derived tissue stromal vascular fraction (AD-tSVF) is now a common~     closed access to subdermal adipose stromal/stem cell population consisting of both stem and~     stromal cells, each of which are felt to contribute a wide variety of effects and potentials.~     Closed, sterile isolation of the AD-cSVF is possible with advent of closed systems to~     enzymatically release these cells from the actual matrix (scaffolding) within the adipose~     tissue complex (ATC). This group of largely un-designated cell population is isolated and~     concentrated via a standard gradient layer separation by centrifugation. This cellular~     isolate is then suspended in an IV of 500 cc Normal Saline and reintroduced to the patient.~      This study is examining the clinical safety and efficacy of this approach, as well as~     tracking the duration of effects and establish a therapeutic interval.~   "
46280|NCT02961101|"~     The purpose of this study is to assess the feasibility, safety, and efficacy of anti-PD-1~     antibody in combination with low-dose decitabine in patients with relapsed or refractory~     malignancies, including Non-Hodgkin'lymphoma, anti-PD-1-resistant Hodgkin'lymphoma,~     gastrointestinal cancers, hepatocellular carcinoma, breast cancer, ovarian cancer or lung~     cancer or renal-cell cancer or pancreatic cancer or bile duct cancer.~   "
46288|NCT02960997|"~     Epidermolysis bullosa (EB) simplex is a rare orphan disease caused by a mutation in DNA~     leading to abnormal dominant keratins in the skin. Patients with EB simplex develop lifelong~     painful thick soles on their feet, and current standard of care is supportive. This pilot~     study will target the dominant mutant keratin proteins in the skin to ameliorate the severity~     of EB simplex. The purpose is to improve the function of EB simplex feet with an application~     of topical sirolimus, 2%. The investigators plan on inhibiting the mTOR pathway to down~     regulate the translation of defective keratin proteins and work through anti proliferative~     pathways.~   "
46358|NCT02960074|"~     This is a Phase I trial to evaluate the safety and efficacy of fecal microbiota~     transplantation (FMT) in the treatment of peanut allergy. In this research the investigators~     would like to learn more about ways to treat peanut allergies. There is currently no known~     cure for peanut allergy. The primary aim is to assess safety and tolerability of oral FMT in~     patients with peanut allergy aged 18-40 years.~   "
46281|NCT02961088|"~     Pasta is an important example of a food which can lower the glycemic index (GI) of the diet,~     a property that has been exploited extensively in studies of low GI dietary patterns.~     Although low-GI dietary patterns have been shown to improve body weight, glycemic control and~     blood lipids, it is unclear whether pasta as part of low-GI dietary patterns will improve~     measures of global adiposity including body weight. The lack of high quality knowledge~     syntheses to support evidence-based dietary guidance of the cardiometabolic benefits of pasta~     represents an urgent call for stronger evidence. To improve evidence-based guidance for pasta~     recommendations, the investigators propose to conduct a systematic review and meta-analysis~     of controlled studies in humans to assess the effect of eating pasta as part of a low GI diet~     compared to other diets on measures of adiposity (body fatness) in humans. The systematic~     review process allows the combining of the results from many studies in order to arrive at a~     pooled estimate, similar to a weighted average, of the true effect. The investigators will be~     able to explore whether eating pasta as part of a low GI diet has different effects between~     men and women, in different age groups and in people with high or normal sugar. The findings~     of this proposed knowledge synthesis will help improve the health of Canadians through~     informing recommendations for the general public, as well as those at risk of heart disease~     and diabetes.~   "
46282|NCT02961075|"~     Impact of Local Anesthesia on Postbronchoscopy Fever: a Randomised Controlled Study~   "
46283|NCT02961062|"~     The purpose of this study is to determine if SAF312 eye drops have an adequate safety and~     efficacy profile to justify further clinical development for the treatment of ocular pain~     associated with corneal epithelial defect such as after photorefractive keratectomy (PRK)~     surgery~   "
46284|NCT02961049|"~     The aim of this study is through a randomized clinical trial, double blind, splith-mouth,~     evaluate the retention rate of restorative protocols of Non-carious cervical lesion. The~     presence of gingival displacement with a retraction cord (yes or no) and the category of~     adhesive system (etch-and-rise and self-etching) will be evaluated. Data will be collected,~     tabulated and submitted to statistical analysis.~   "
46285|NCT02961036|"~     Questionnaires are frequently used in online research, however recruiting, and completion~     rates of online participants from a variety of cultures and demographic backgrounds can be~     challenging. The challenge is greater in an online cohort because there is no way to observe~     the participant beyond what is contributed online. Poor recruiting and completion can result~     in underpowered research that may not be representative of the sample population. This can~     trigger an increase in costs as the recruitment period may have to be extended until sample~     size is reached. When recruiting and completion rates are inadequate studies may have to be~     terminated and the answer to the research question can remain unknown.~      To mitigate these challenges, incentives may be offered in the form of gift certificate~     draws. There is uncertainty about whether this strategy is effective in online research and~     if the value of the incentive alters the outcome. A randomised trial can be used to test the~     intervention to establish an evidence base.~      This study (SupMatQT) proposes to link with a large 20,000 person international cohort study~     (SupMat) that will test the utility and preferences of journal supplementary materials for~     reviewers, authors,and readers. The research described here will examine the evidence of~     effect for offering a prize draw incentive on rates of recruitment, and completion for~     consented participants. All participants will be entered in the draw. Information about the~     value of the incentive of a prize draw will differ according to what group a participant is~     randomized to. The entry in the prize draw will not be conditional on levels of participation~     or group allocation.~      The other question researchers will address is what effect do survey reminders have on~     outcomes? All non-responders will be sent an initial reminder to complete the survey (Group~     A) and for those who have still not responded a second reminder will be sent 14 days later~     (Group B). Outcomes will be compared at three time points: for initial response, following~     reminder 1(Group A), and following reminder 2 (Group B).~   "
46286|NCT02961023|"~     Exercise capacity (EC) is limited in pulmonary arterial hypertension (PAH) by impaired right~     ventricular (RV) function and inability to increase stroke volume (SV). Disease targeted~     therapy, increases EC by improving SV. Additional factors may contribute to exercise~     limitation:~        -  Peripheral and respiratory muscle dysfunction~        -  Autonomic dysfunction~        -  An altered profile of inflammation~        -  Mitochondrial dysfunction.~      The enhancement of EC achieved pharmacologically may therefore be limited. Exercise training~     in PAH improves EC and quality of life (QOL). The changes in physiology responsible for this~     improvement are not clear. Patients with PAH stable on optimal oral therapy, but not meeting~     treatment goals, will be enrolled in a 30-week randomised exercise training program.~      One arm will undertake training for 15 weeks (3 weeks residential, 12 outpatient), the other~     will receive standard care for 15 weeks then 15 weeks training.~      Aims:~        1. Demonstrate that exercise training can enhance EC and QOL when added to optimal drug~          therapy a UK PAH population.~        2. Explore mechanisms of exercise limitation and factors that improve with training,~          assessing:~             -  Cardiac function~             -  Skeletal muscle function~             -  Autonomic function~             -  Respiratory muscle strength~             -  Serum and muscle profile of inflammation~      Primary outcomes (15 weeks)~        1. 6 minute walk distance~        2. QOL~        3. RV ejection fraction~   "
46287|NCT02961010|"~     This study evaluates the effectiveness of Keeping Safe, a whole school preventative education~     intervention in improving children's knowledge and understanding to keep safe in situations~     of abuse. The intervention~        -  Comprises three themes (1) Healthy Relationships; (2) My Body; and (3) Being Safe and~          includes content across the following keeping safe concepts; bullying, neglect,~          emotional, physical, domestic and sexual abuse, in online and offline contexts.~        -  Includes activities for the formal and informal school curricula - 63 lessons will be~          taught to children by their classroom teacher; 3 per term, 9 per year across 7 years~          from Primary 1 to primary 7 (age 4-11 years).~        -  Each lesson is accompanied by directed homework activities to involve and engage parents~          and enable them reinforce learning at home. A number of whole school, key stage and year~          group assemblies have also been prepared.~        -  At the beginning of each term school leaders will deliver a prepared assembly to~          introduce the theme for the term. Following this assembly each teacher will deliver 3~          lessons tailored to the age group of their class and parents will assist with home~          works. The lessons use eBooks, character animations, stories, rhymes, and interactive~          whiteboard activities to engage children in their learning.~      The intervention adopts a whole-school approach and seeks to build the capacity and skills of~     teachers and parents as key partners. Teachers will receive a comprehensive package of~     training, ongoing support and resource materials to equip them with the skills they need to~     effectively communicate sensitive keeping safe messages. Parents will also receive a package~     of resources to help them feel confident about communicating sensitive messages to their~     children.~   "
46339|NCT02960321|"~     A prospective study aiming to analyse the relation between different variables and high~     sensitivity troponin I (hsTnI) elevation within a group of patients undergoing a coronary~     angiography with or without subsequent percutaneous coronary intervention.~   "
46289|NCT02960984|"~     In Multiple Sclerosis the multiplicity of physical and psychological dysfunctions have been~     shown to exhibit a number of life-altering problems such as fatigue, limb weakness,~     alteration of upper extremity fine motor coordination, loss of sensation, spasticity. These~     problems affect performance of many daily living activities (ADL) such as dressing, bathing,~     self-care, and writing, thus reducing functional independence and self-rated quality of life.~      Twenty people with Multiple Sclerosis will receive neurorehabilitation treatment comprising a~     combination of aerobic training and upper limb task-oriented training.~      The aim of this pilot crossover study is to evaluate the effects of neurorehabilitation on~     upper limb performance and on fatigue in People with Multiple Sclerosis.~   "
46290|NCT02960971|"~     To understand pain pathophysiology in terms of risk factors and protective mechanisms ranging~     from molecular pathways to societal impacts.~   "
46291|NCT02960958|"~     The aim of this study is to investigate discriminant metabolites in urine from patients with~     rheumatoid arthritis (RA) from healthy individuals. Then we determine if the patient's~     metabolic fingerprint could predict the development or flare-up of RA.~   "
46292|NCT02960945|"~     This study will assess the metabolite and pharmacokinetic (PK) profile of a single dose of~     CTP-543 compared to a single dose of Jakafi® in healthy volunteers.~   "
46293|NCT02960932|"~     Muscles, paretics and spastics, of cerebral palsy children have very early, for growth (three~     at five aged), every alteration of theirs properties. Gastrocnemius muscle, often reaches on~     the cerebral palsy, characterised by a modification of the structure (volume decrease) and~     the elasticity (increase of the passive stiffness). Every alterations of the muscular~     property have impact clinic and functional important. The many treatments of orthopaedic~     targeting (lengthening of cast, injections of botulinic toxin), repeated to a multiple~     recovery during the growth influences the muscular characteristics. There is a real interest~     to measure the muscular property development during children's growth.~   "
46294|NCT02960919|"~     This is a prospective observational study assessing the clinical outcomes of children 2 to 59~     months of age with both pneumonia and other co-morbidities presenting to a tertiary hospital~     outpatient setting in Malawi, Africa who are most at risk for mortality or have other~     complications and thus, are typically excluded from childhood pneumonia studies.~   "
46295|NCT02960906|"~     Disease and Stage: naïve metastatic kidney cancer.~      A multicenter, randomized, a Phase 2 BIOmarker driven trial with Nivolumab and Ipilimumab or~     VEGFR tKi in naïve metastatic Kidney cancer~   "
46296|NCT02960893|"~     The purpose of this study is to compare the efficacy of BHV-4157 versus placebo on ataxia~     symptoms in subjects with spinocerebellar ataxia (SCA).~   "
46297|NCT02960880|"~     The aim of this study is to assess the real world comparative effectiveness of Rivaroxaban~     prescribed in non-valvular atrial fibrillation (NVAF) routine care patients in Germany.~   "
46298|NCT02960867|"~     Acute kidney injury (AKI) is a frequent clinical condition in hospitalized, in particular, in~     critically ill children. Moreover, AKI is an independent predictor of mortality. An incidence~     of AKI in pediatric intensive care units (PICU) between 10 and 62% has been reported in~     recent clinical trials adopting pRIFLE or AKIN criteria, with the highest risk present in~     cardiac surgery patients. Despite significant developments in the management of AKI, the~     overall mortality rate of patients with AKI has not improved significantly. Currently, there~     is no consensus concerning the optimum dialysis modalities to adopt in pediatric AKI. No~     studies have prospectively compared the efficacy of different types of RRT for pediatric AKI.~     While PD remains the most commonly used modality in children worldwide, over the last decade~     CRRT has become the preferred treatment modality for critically ill children with AKI in~     North America.~      The investigators have recently conducted a survey among 34 European Pediatric Nephrology~     Centers in the ESCAPE Network to obtain current information on dialysis management practices~     in children. Approximately 900 children with AKI requiring dialysis are managed at these 34~     centers per year. This number supports the creation of a prospective European AKI registry.~   "
46299|NCT02960854|"~     A study to evaluate the safety, tolerability and pharmacokinetics of Nivolumab in~     participants with severe sepsis or septic shock.~   "
46300|NCT02960841|"~     The aim of this study was to determine the effectiveness of Intracavitary Manual Lymphatic~     Drainage (IMLD) in the reduction of the perineal trauma and the symptoms of vaginal edema,~     the prevention of complications during the expulsive and the improvement in the postpartum~     recovery, compared to conventional treatment during the gestation, in women with the second~     partum. The weekly treatment is performed from the 25th gestational week in women with vulvar~     edema.~   "
46301|NCT02960828|"~     This study aims to validate the efficacy and safety of subthreshold laser photocoagulation on~     high-risk macular drusen in early age-related macular degeneration which has a high risk of~     conversion to exudative AMD.~   "
46302|NCT02960815|"~     In this open label, single centre, pilot randomized controlled clinical trial the~     investigators aim to compare the immunogenicity and safety of a new influenza vaccination~     strategy consisting in the topical administration of imiquimod at the injection site before~     vaccination vs. a standard intramuscular vaccine injection in SOT recipients and HIV-infected~     individuals. The investigators planned to enroll 70 outpatients patients (50% solid-organ~     transplant recipients and 50% HIV-infected patients) regularly followed at the~     Transplantation center and the Infectious disease outpatients' clinics of the Lausanne~     University Hospital. Study participants will be randomized in a 1:1:1 ratio to receive the~     standard intramuscular vaccine (control group) or a topical application of an imiquimod~     containing cream followed by intramuscular (imiquimod-IM) or intradermal (imiquimod-ID)~     vaccine injection. After vaccination participants will be followed for a period of 180 days.~     Blood samples will be drawn at baseline and at day 21 and 180 for assessment of~     immunogenicity. Safety outcomes will be assessed immediately after vaccine administration,~     and at day 7 (phone call), 21 and 180.~   "
46340|NCT02960308|"~     This pilot clinical trial studies how well whole-neck computed tomography perfusion scans~     work in imaging patients with head and neck tumors. Diagnostic imaging procedures, such as~     whole-neck computed tomography perfusions scans, may provide more information about the blood~     supply to head and neck tumors which may help doctors plan better treatment.~   "
46303|NCT02960802|"~     The cardiovascular morbidity and mortality is significantly higher in chronic kidney disease~     (CKD) patients, especially in dialysis patients, than in normal population. The increased~     risk of cardiovascular diseases is multifactorial.Endothelial dysfunction is one of the~     explanations for the poor outcome of kidney patients. The kidney transplantation seems to~     halt the progression of the cardiovascular morbidity.~      Coronary flow reserve (CFR), the capacity of coronary vessels to dilate in response to~     vasoactive agent, is a marker of the endothelial dysfunction. It is reduced in renal~     impairment as well as in many preatherosclerotic states and coronary heart disease. The~     method of choice to evaluate CRF is positron emission tomography (PET). In kidney transplant~     patients CFR seems to be worse than in healthy controls but better than in dialysis patients.~     However, the evidence is scarce.~      Renal flow reserve (RFR) is smaller than that of heart. RFR probably reflects endothelial~     function in the same way as CFR does. Declining RFR could perhaps be used to anticipate~     worsening kidney function especially in kidney transplant patients and be in favour for~     transplant biopsy.There are no studies of RFR in renal allograft patients.~      The objectives of this study are to examine the effect of kidney transplantation on coronary~     flow reserve (CFR), the change of renal flow reserve (RFR) in kidney transplant patients~     during the first year after transplantation and assess the correlation between the change of~     renal blood flow / RFR and kidney biopsy findings in kidney transplant patients.~      The first hypothesis of this study is that coronary flow reserve of transplant patients is~     better than that of dialysis patients but worse than that of healthy controls. The second~     hypothesis is that renal transplant perfusion reserve is better at one year than at three~     months after transplantation. The third hypothesis is that pathologic kidney biopsy findings~     correlate negatively with renal perfusion reserve.~   "
46304|NCT02960789|"~     A pediatric study in collaboration with Boston Children's Hospital to review the performance~     of two novel hydration status measurement devices against standard clinical assessment~     methods, through repeated measurement of hydration status of dehydrated children admitted to~     the emergency department receiving rehydration therapy, followed by an at-home follow-up~     measurement once symptoms have resolved.~   "
46305|NCT02960776|"~     The overall goal of this project is to look at the effects of long-term, sustained sleep~     restriction (SR) in adults, and assess the effects on mood and cognitive and physical~     performance.~   "
46306|NCT02960763|"~     The purpose of this research study is to assess which antidepressants work the best in older~     adults who have treatment-resistant depression (TRD).~   "
46307|NCT02960750|"~     This study assesses the short and mid-term impacts of a workplace web-based intervention~     (Walk@WorkSpain, W@WS) on self-reported occupational sitting time, step counts,~     activity-related energy expenditure, physical risk factors for chronic disease and~     efficiency-related outcomes in Spanish office employees. Half of participants had access to~     the W@WS website program while the other half was asked to maintain habitual behaviour.~   "
46308|NCT02960737|"~     The purpose of this study is to investigate the effect of a specific rehabilitation program~     with oral screen used in stroke patients with persistent oral-and pharyngeal dysphagia.~   "
46309|NCT02960724|"~     uPAR PET/CT for Staging Advanced and Localised oral and oropharyngeal cancer~   "
46310|NCT02960711|"~     Phase III randomized controlled trial on men and women with Metabolic syndrome (MetS) to test~     the hypothesis that comprehensive life-style changes and/or metformin treatment prevent~     age-related chronic non-communicable diseases (ArCD).~      The aim of the present study is to evaluate the effect of a comprehensive life-style~     intervention (including moderate physical activity and Mediterranean/macrobiotic diet with~     moderate calorie and protein restriction), and of treatment with Metformin (a calorie~     restriction mimetic drug) for the prevention of ArCD.~   "
46311|NCT02960698|"~     Tourette syndrome (TS) is characterized by the presence of multiple vocal and motor tics.~     Behavioral disorders associated with TS are common, particularly impulsivity, anti-sociality~     and socially inappropriate behavior. Specifically, cognitive impulsivity could be the source~     of these troubles. Its anatomical substrates is based on connections between frontal and~     striatal areas.~      Initially, a battery of behavioral tests measuring different types of impulsivity (motor,~     cognitive and decision) will be administered on three groups of subjects: TS: 80 patients (40~     patients treated and 40 untreated) and 40 healthy volunteers.~      Then, investigators will study the fronto-striatal connections in the TS group of 80 patients~     (40 patients treated and 40 untreated) compared to 40 healthy volunteers using neuroimaging~     techniques (3T MRI). The techniques used will be functional connectivity study of resting~     state MRI (RS-fMRI) combined with a reconstruction of white matter fibers by diffusion~     tensor imaging (DTI). Behavioral performance will be correlated with the correlation imaging~     data to highlight the functional anatomical substrates of impulsivity in patients with TS.~      Finally, investigators will look specifically using functional MRI activation, the anatomical~     and functional substrates of the three types of impulsivity (motor, cognitive and~     decision-making).~      Through this study, investigators hope to elucidate the anatomical and functional bases of~     cognitive impulsivity in patients with TS and thus lay the basis for more targeted~     treatments.~   "
46312|NCT02960685|"~     Background: Given that an experienced physician is not always available 24 hours a day,~     immediately and always available echocardiography is usually impossible in the emergency~     department (ED) and intensive care unit (ICU). To compensate this limitation, the~     investigators have investigated that offsite expert guided, inexperienced~     practitioner-performed ultrasonography could be effectively performed. In this study, the~     investigators aimed to investigate whether the offsite expert can effectively evaluate the~     visually estimated ejection fraction (EF) while watching and guiding the echocardiographic~     procedure of onsite novice examiner using the social network video calling chat.~      Methods: sixty patients presenting to the ICU and requiring echocardiography will be~     included. Sixty novice practitioners without any previous experience of echocardiography will~     participate. Prior to their procedure, the onsite expert complete the echocardiography in~     advance and determine the EF using the modified Simpson's method (MSM, Reference value).~     Then, the novice physicians perform the echocardiography again with the offsite expert's~     guidance via video call. They obtain parasternal long and short axis view and EF is visually~     estimated to the nearest 5% (ex. 40%, 45% and etc) by the offsite expert while watching the~     ultrasound video on the smartphone display. The subjects requiring immediate management due~     to severe symptoms were excluded in this study. Interobserver variability between the~     calculated by onsite expert and visually estimated by offsite expert was assessed. The~     agreement of the visual estimated EF obtained by onsite expert and offsite expert via~     smartphone was evaluated by linear regression and Bland-Altman plots.~   "
46313|NCT02960672|"~     Interstitial lung disease is a chronic progressive fibrosis lung disease that with a highly~     variable clinical process.thence it is significant for the patient to search a convenient and~     accurate prediction method. The objective of this study was to determine whether peripheral~     blood biomarkers can predict disease .~   "
46314|NCT02960659|"~     Background:~      The pill metformin treats diabetes. But it does not work for all youth, especially~     African-Americans. The injectable Liraglutide treats type 2 diabetes in adults. Researchers~     want to understand how these drugs work and if they decrease excess sugar made by the liver~     in youth with type 2 diabetes.~      Objective:~      To test if using liraglutide and metformin are better than just metformin for decreasing~     excess sugar produced by the liver in African-American youth with type 2 diabetes.~      Eligibility:~      African-Americans ages 12-21 with type 2 diabetes~      Design:~      Visit 1: Participants will be screened with medical history, physical exam, and blood and~     urine tests.~      Participants will stop taking diabetes medicines for 1 week. They will learn how to check~     blood sugars at home twice a day.~      Visit 2: Overnight at the clinic. Participants will have:~      Vital signs taken.~      Pregnancy test.~      A thin plastic tube (IV catheter) be inserted in each forearm by needle.~      Blood drawn several times after drinking a sweet drink.~      X-ray of total body fat.~      Urine and stool collected.~      Breath tests while wearing a clear hood for up to 45 minutes.~      For several hours, participants can have only water. At 4 a.m. they will get sugar and fat~     with nonradioactive isotopes in one IV. Blood will be collected. Every 30 minutes from 9 a.m.~     to 2 p.m., they will drink small amounts of a shake and have blood drawn.~      Participants will be randomly assigned to take either both study drugs daily or just~     metformin daily.~      Visits 3 4: Participants will bring their blood sugar records and have blood tests.~      Visit 5, after 3 months: Repeat of visit 2....~   "
46315|NCT02960646|"~     The goal of this clinical research study is to learn if giving a modified stem cell~     transplant is less likely to cause graft-versus-host disease (GVHD) to patients with certain~     types of blood disorders or blood cancers make patients less likely to develop GVHD. You will~     also receive melphalan and fludarabine as part of your regular chemotherapy and total body~     irradiation (TBI) regimen.~      Before you receive the stem cell transplant, it will be modified to remove certain types of~     T cells that cause GVHD.~      GVHD occurs when transplanted immune tissue, such as T cells and stem cells, attacks the~     tissues of the recipient's body.~   "
46316|NCT02960633|"~     Direct Anterior Approach (DAA) for Total Hip Arthroplasty (THA): Corail prosthesis with or~     without collar design. Randomized study design focusing on radiolucent lines on standard~     x-ray.~   "
46317|NCT02960620|"~     This is not a research study. The purpose is to provide supervised access to TheraSphere®~     therapy at this institution.~   "
46318|NCT02960607|"~     The purpose of this study is to investigate whether high-dose icotinib treatment beyond~     disease progression is beneficial for NSCLC patients who have EGFR mutation and who have~     responded to EGFR TKI.~   "
46319|NCT02960594|"~     This is a Phase I, open label study to evaluate the safety, tolerability, and immunogenicity~     of INO-1400 alone or in combination with INO-9012, delivered by electroporation in subjects~     with high-risk solid tumor cancer with no evidence of disease after surgery and standard~     therapy. Subjects will be enrolled into one of six treatment arms. Subjects will be assessed~     according to standard of care. Restaging and imaging studies will be performed to assess~     disease relapse per NCCN guidelines. RECIST will be used to validate the findings in cases of~     relapse.~   "
46320|NCT02960581|"~     This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and anti-viral~     efficacy of the PGT121 monoclonal antibody for HIV prevention and therapy.~   "
46321|NCT02960568|"~     The investigator proposes to 2D6 (Cytochrome P-450 Isoenzyme 2D6) genotype and phenotype a~     group of active duty service members and assess the effects on primaquine metabolism.~   "
46322|NCT02960555|"~     The goal of this clinical research study is to learn if isatuximab can help to control~     smoldering multiple myeloma (SMM). The safety of this drug will also be studied.~      This is an investigational study. Isatuximab is not FDA approved or commercially available.~     It is currently being used for research purposes only. The study doctor can explain how the~     study drug is designed to work.~      Up to 61 participants will be enrolled in this multicenter study. Up to 42 will take part at~     MD Anderson.~   "
46323|NCT02960542|"~     This pilot study is designed to adapt a community-based diabetes prevention program to reach~     adults at risk for cancer.~   "
46324|NCT02960529|"~     Inguinal hernia is a common disease in children. Treatment of this disease by laparoscopic~     high ligation of the hernia sac has been accepted by domestic and foreign scholars. Since~     laparoscopic inguinal hernia was introduced in 1990,it has now become the most commonly~     performed hernia repair in children. The conventional approach this is done with2small~     trocars to 1trocar . however the wound complications of infection and pain and the recurrent~     rate have not been resolved. The aim of the study was to described a new way of~     extra-peritoneal high ligation of hernia sac. This method combines the single-port~     laparoscopic could eliminated rate of wound complications and recurrence in inguinal hernia~     repair in children. The investigators hoped that this study will prove that the~     extra-peritoneal single-port laparoscopic repair is at least a s effective and efficient as~     the conventional technique in the cure of inguinal hernia and may results in lower recurrence~     and reduce incidence of wound complications.~   "
46325|NCT02960516|"~     It is estimated that up to 5% of all admissions to level one trauma centers have a peripheral~     nerve injury. These peripheral nerve injuries may have devastating impacts on quality of life~     and require months or years to regain function. Neurotmesis, or peripheral nerve transection,~     is a common injury, with singly cut nerve lacerations accounting for over 60% of the~     peripheral nerve surgical interventions in civilian studies. For recovery to occur in these~     patients, axons must grow from the site of repair to the target tissues, a length of up to a~     meter in humans. By that time, revisional surgery may not be a viable option due to the onset~     of irreversible muscle atrophy - a transected nerve is estimated to induce a loss of~     achievable function of approximately 1% for every 6 days of delay. The scenario is even worse~     for more proximal nerve injuries, such as those that occur in the brachial plexus.~      The investigators aim is to longitudinally assess diffusion tensor tractography (DTI) in~     order to optimize, validate, and translate the ability of DTI to monitor and, more~     importantly, predict nerve regrowth following trauma and surgical repair. The overall~     objective of this study is to evaluate the ability of (DTI) to monitor and, more importantly,~     predict nerve regrowth following crush or cut with surgical repair. The investigators~     hypothesize that the additional information available via DTI will improve our ability to~     monitor and predict nerve regrowth following surgical repair or severe crush injury, guiding~     clinical management either toward or away from surgical intervention.~   "
46326|NCT02960503|"~     Sickle cell anemia (SCA) is a life-threatening, monogenic disorder associated with early~     death when compared to individuals without SCA. Pulmonary complications, namely acute chest~     syndrome, obstructive lung disease and pulmonary hypertension, are the most common causes of~     death in patients with SCA. Recent studies suggest that lung specific inflammation is a~     hallmark of SCA and underlies pulmonary pathology. To date, no therapy has been shown to~     improve the pulmonary complications of SCA. Macrolides have pleomorphic effects in the lung~     with improvement in pulmonary function, symptoms and inflammatory markers demonstrated in~     several inflammatory pulmonary conditions such as cystic fibrosis, asthma, COPD and~     post-transplant bronchiolitis obliterans. Investigators hypothesize that low dose macrolide~     therapy is well tolerated and can improve pulmonary function and symptoms in patients with~     SCA. The objective of this project is to assess the feasibility of macrolides to attenuate or~     reverse the decrease in %predicted FEV1 in adults with SCA in a single-site, randomized,~     placebo-controlled feasibility trial.~   "
46327|NCT02960490|"~     This study is a multicenter, randomized, double-blind, placebo-controlled, parallel-group~     comparison study in rheumatoid arthritis participants inadequately responding to biologics.~   "
46328|NCT02960477|"~     BACKGROUND Shoulder pain is the third most common musculoskeletal disorder observed in~     primary care consultations after low back and neck pain. In the absence of successful outcome~     following a conservative intervention, shoulder surgery is the most common procedure conduct~     for a multitude of surgical indications, including rotator cuff tears, instability and~     stiffness. However, 22% of patients develop chronic shoulder pain (CSP) following shoulder~     surgery . The consequences of chronic or persistent postsurgical pain result in high~     socio-economic burden, not only in terms of suffering and reduced quality of life for the~     individual, but also, with considered the subsequent costs to healthcare and social services.~      Pain neuroscience education (PNE) has been shown as an effective therapeutic strategy for~     increasing knowledge and understanding about neurobiology, neurophysiology and processing~     pain, changing pain beliefs, improving patient's skills and encouraging to do physical and~     social activities in different chronic pain conditions.~      The primary aim of this study will be to evaluate whether perioperative PNE is more effective~     than classical biomedical education in reducing pain and disability in patients undergoing~     shoulder surgery. The secondary aim will be to analyse whether perioperative PNE is more~     effective than classical biomedical education in reducing postoperative healthcare costs and~     improving surgical experience in patients undergoing shoulder surgery .~   "
46329|NCT02960464|"~     Investigation of possible benefits of transcranial direct current stimulation (tDCS) as a~     treatment of depression in patients with Parkinson's Disease, through a randomized~     placebo-controlled clinical trial.~   "
46330|NCT02960451|"~     The purpose of this study is to determine whether specialty care is superior to usual care in~     the treatment of patients at clinical high risk for psychosis.~   "
46331|NCT02960438|"~     This study is a multicenter, randomized, double-blind, placebo-controlled, parallel-group~     comparison study in rheumatoid arthritis participants inadequately responding to~     methotrexate.~   "
46332|NCT02960425|"~     Creatine is a nutritional supplement that is often ingested to improve exercise performance.~     The advent of a new product that is applied to the skin overlying muscle offers potential~     benefit, if the creatine can be targeted to specific muscles. The investigators are testing a~     novel creatine cream to determine the effects on human muscular performance. The~     investigators are assessing the acute application of two different doses of the creatine~     cream on muscular power (determined by knee extension).~   "
46333|NCT02960412|"~     This study evaluates if administration of IV furosemide leads to expedited confirmation of~     ureteral patency when compared to placebo (IV saline) in routine cystoscopy performed after~     urogynecologic surgery.~   "
46334|NCT02960399|"~     Recommendations concerning the administration of Zostavax® in patients with antibody~     deficiency are unclear. The investigators plan to assess the immunogenicity and safety of~     Zostavax® in patients with antibody deficiency as compared with healthy volunteers.~   "
46335|NCT02960386|"~     The iTrackFitness study aims to test the engagement engine that was developed from activity~     tracker and survey data gathered during phase I of the study. For the current phase the~     engagement engine will support successful and sustained engagement with health trackers~     thereby increasing physical activity.~   "
46336|NCT02960373|"~     Dried fruits show promising potential for the management of blood glucose. Previous trials~     have reported beneficial effects of raisins on post-prandial glucose and insulin responses in~     healthy individuals when compared with white bread. However, to date there is limited data~     evaluating the potential beneficial effects of other dried fruits (i.e. sultanas, dates and~     apricots). It is also unclear whether dried fruits can be used to lower the postprandial~     glycemic responses to high-GI carbohydrate foods by either displacing available carbohydrate~     (displacement effect) or providing 'catalytic' doses of fructose ('catalytic' fructose~     effect). To address these questions, the investigators propose to assess the GI of 4 common~     types of dried fruit (raisins, sultanas, dates, apricots) (GI effect) and their ability to~     decrease the postprandial glycemic response to white bread by either partially displacing~     available carbohydrate (displacement effect) or by providing a 'catalytic' dose of fructose~     ('catalytic' fructose effect).~   "
46337|NCT02960347|"~     The current study examined the feasibility of High-Definition tDCS (HD-tDCS) in reducing~     epileptiform activity in a 30-month-old child suffering from early onset epileptic~     encephalopathy. HD-tDCS was administered over 10 intervention days spanning two weeks~     including pre- and post-intervention video-electroencephalography (EEG) monitoring.~   "
46338|NCT02960334|"~     Atrial Fibrillation (AF) It is the most common arrhythmia in the world. It carries great~     public health significance because of its prevalence, additional morbidity and mortality. It~     provides a 4-5 times higher risk of developing a ischemic stroke or transient ischemic~     attack. In term, this risk can be 70% reduced by taking oral anticoagulants. Actionable AF is~     the overarching term for silent AF (asymptomatic AF) and undertreated AF (known AF, but not~     sufficiently protected against ischemic stroke). It is recommended that over the age of 65,~     patients should be screened with pulse palpation or rhythm strip for the presence of AF. The~     MyDiagnostick is a single-lead I, compact hand-held device that analyses heart rhythm during~     one minute. During preoperative consultation, this device will be used to value the yield of~     screening for actionable AF.~   "
46341|NCT02960295|"~     This is a feasibility study of care for women with gestational diabetes (GDM) using~     electronic equipment to participate in virtual office visits.~      Participants will be trained in the use of glucose meters, scales, and sphygmomanometers~     which are Bluetooth connected to an app on their cellphones. Fetal well-being will be~     assessed with Dopplers and kick counts. Care will be delivered by alternate in-office and~     telephone visits.~   "
46342|NCT02960282|"~     This research trial studies the gut microbiome in fecal samples from patients with cancer~     that has spread to other parts of the body who are undergoing chemotherapy or immunotherapy.~     Studying samples of feces from patients with metastatic cancer in the laboratory may help~     doctors learn if the make-up of the gut microbiome has a positive or negative influence to a~     patient's response to chemotherapy or immunotherapy.~   "
46343|NCT02960269|"~     This pilot study will evaluate the impact and overall experience of an interprofessional~     chronic low back pain patient care approach for people in rural and remote areas using~     Telehealth technology compared to secure laptop based videoconferencing (Vidyo).~   "
46344|NCT02960256|"~     Sepsis related to the development of cardiac complications. However, the investigators~     understanding regarding this condition remains incomplete. Possible explanations raised~     include coronary perfusion decrease, activation of the coagulation system and release of~     inflammatory mediators, including endotoxins, cytokines and others.~      In this study the investigators wanted to examine the impact of any infectious disease, (not~     necessarily Pneumonia), on the QT interval in patients hospitalized for acute infectious~     disease.~   "
46345|NCT02960243|"~     Deep Brain Stimulation (DBS) is the gold standard treatment for Essential Tremor (ET). ET is~     a movement disorder which causes the arms, feet, fingers, head or voice to involuntarily~     shake. The DBS surgical procedure involves implanting an electrode deep within the brain~     which blocks damaging signals that cause the tremor. Essential Voice Tremor (EVT) is the~     vocal manifestation of ET and a number of individuals have both ET and EVT, and when these~     patients are implanted for their ET, their EVT symptoms are often also mitigated. This study~     aims to quantify the effects of DBS on EVT by testing on these ET+EVT patients. In addition~     to this, we hope to determine which hemisphere of the brain is responsible for larynx~     control: left or right.~   "
46346|NCT02960230|"~     This is a two cohort Phase I study within the Pacific Pediatric Neuro-Oncology Consortium~     (PNOC).~      This study will assess the safety of repeated administration of the H3.3K27M specific vaccine~     in HLA-A2+ children and young adults with H3.3K27M DIPGs and other gliomas.~   "
46347|NCT02960217|"~     UX007G-CL301 is a Phase 3, randomized, double-blind, placebo-controlled, crossover study to~     assess the efficacy and safety of UX007 in the treatment of movement disorders associated~     with Glucose Transporter Type 1 Deficiency Syndrome. The study will enroll approximately 40~     subjects who experience disabling paroxysmal movement disorders.~   "
46348|NCT02960204|"~     This is a multicenter, randomized, double-blind, placebo-controlled trial involving subjects~     with NASH cirrhosis and severe portal hypertension (defined as HVPG ≥12 mmHg as determined by~     the central reader assigned to this study). Upon successful screening, subjects will be~     randomized to receive either emricasan 50 mg BID, 25 mg BID, or 5 mg BID or matching placebo~     BID.~   "
46349|NCT02960191|"~     The main objective is to highlight, by functional imaging (MRI) dysfunctional brain regions~     associated with vulnerability to suicidal behavior.~   "
46350|NCT02960178|"~     Falling is common among individuals with incomplete spinal cord injury (iSCI), with most~     falls occurring while walking. Falls result in injuries (e.g., broken bones), hospital~     readmission, and reduced participation in work and recreation. In able-bodied people, falls~     can be prevented by taking one or more rapid, reactive steps. People with iSCI, however, have~     difficulty taking the reactive steps needed to prevent a fall. Research in the elderly and~     people with stroke has shown that repetitive training of reactive steps in a safe environment~     improves this balance reaction and prevents falls. The investigators will examine the~     feasibility and effectiveness of reactive step training in people with iSCI. The main~     objective is to determine if reactive balance training leads to greater improvements in~     balance reactions, scores on clinical scales, and fall rates compared with conventional~     walking training. A three year, pilot randomized clinical trial (RCT) will be completed. By~     improving balance and reducing falls, people with iSCI will experience fewer complications~     (e.g., injuries), and greater recovery of function and community participation.~   "
46351|NCT02960165|"~     Objective: Evaluate whether a task practiced in virtual environment could provide better~     performance than the same task in real environment and if performing a task in virtual~     environment could enable transfer to the same task in real environment and vice versa.~     Method: the investigators evaluated 65 older adults of both genders, aged 60-82 years. The~     investigators applied a timing coincident task to measure the perceptual-motor ability to~     perform a motor response. The participants were divided into two groups: a) started in a real~     interface and b) started in a virtual interface.~   "
46352|NCT02960152|"~     This study evaluated the periodontal status of patients suffering from eating disorders~     (anorexia nervosa and bulimia nervosa). The work hypothesis is that eating disorder patients~     have a higher risk for periodontal diseases than non-eating disorder subjects.~   "
46353|NCT02960139|"~     The Cohera Sylys® Surgical Sealant study is a pivotal, prospective, randomized, controlled,~     multicenter superiority clinical study comparing standard anastomosis closure technique~     (Control) to standard closure technique plus Sylys® Surgical Sealant (Test) during stapled~     colorectal and ileorectal anastomosis procedures.~   "
46354|NCT02960126|"~     This study was designed in order to evaluate and compare the efficacy and safety between~     aspirin and clopidogrel in the patient with low stroke risk Atrial Fibrillation (AF).~   "
46355|NCT02960113|"~     The purpose of this study is to compare the effectiveness of reducing intra-cesarean section~     nausea and vomiting with regional anesthesia in subjects who will receive scopolamine patch~     with acupressure point P6 stimulation versus subjects that receive just scopolamine patch~     versus subjects that receive just acupressure point P6 stimulation.~   "
46356|NCT02960100|"~     This randomized pilot trial studies how well a mobile health (mHealth) intervention works in~     increasing human papillomavirus (HPV) vaccination among college students at the Ohio State~     University. mHealth educational intervention may communicate information about HPV~     vaccination and increase HPV vaccine uptake in college students.~   "
46361|NCT02960035|"~     This is a randomized, double-blind, multicentral clinical trial to investigate the efficacy~     of Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc fusion protein injection~     (Yisaipu®) in the treatment of peripheral enthesitis in active axial spondyloarthritis(SpA)~     patients. Mardird sonographic enthesis index (MASEI) was one of the most wide used scoring~     systems for peripheral enthesitis and the only one based on OMERACT definition of~     enthesopathy by EULAR. The primary purpose is to assess the MASEI to discover the value of US~     in diagnosis and prognosis. The second prupose is to assess different maintaining treatment~     programme in SpA patients with improvement of MASEI. The trial will include 96 patients with~     stable NSAIDs therapy, and at the first stage they will receive 24-week full-dose of~     Yisaipu®. Then at the second stage the patients who achieve low disease activity (LDA,~     ASDAS<2.1) at 24th week will be randomizedly divided into three group: full-dose of Yisaipu®~     group, half-dose of Yisaipu® group and placebo group. And the blind stage will last for 24~     weeks. Patients who complete the 48-week therapy or achieve disease-flare criteria during the~     blind stage would finish the study.~   "
46362|NCT02960022|"~     The purpose of this study is to collect long term safety data in subjects who are continuing~     to derive clinical benefit from treatment with Enzalutamide from the subjects participation~     in an enzalutamide clinical study sponsored by Astellas or Medivation (i.e., parent study)~     which has completed, at a minimum, the primary analysis or the study specified evaluation~     period.~   "
46363|NCT02960009|"~     High definition tDCS will be conducted to both stroke and healthy subjects on primary motor~     cortex area to explore the motor excitability changes before and after stimulation.~   "
46364|NCT02959996|"~     This is a randomized controlled trial to test whether the use of liposomal bupivacaine at the~     time of cesarean delivery may decrease post-operative pain scores.~   "
46365|NCT02959983|"~     This study will evaluate the efficacy and safety of eluxadoline 100 milligrams (mg) twice a~     day (BID) versus placebo for the treatment of patients with Irritable Bowel Syndrome with~     Diarrhea (IBS-D) who report that the use of loperamide in the prior 12 months failed to~     provide control of their IBS-D symptoms.~   "
46366|NCT02959970|"~     This study will evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of~     ACZONE Gel, 7.5% administered topically once-daily for 12 weeks in 9 to 11 year-olds with~     acne vulgaris.~   "
46367|NCT02959957|"~     This study will evaluate the ecological impact on the intestinal microbiota and compare the~     safety and efficacy of temocillin compared to cefotaxime, in empiric treatment of febrile~     UTI. Half of participants will receive temocillin and the other half will receive cefotaxime.~   "
46368|NCT02959944|"~     To evaluate the safety and efficacy of ibrutinib in combination with prednisone in subjects~     with newly diagnosed moderate to severe cGVHD.~   "
46369|NCT02959931|"~     The investigators aim to evaluate the acute effects of potassium supplementation achieved by~     ingestion of potassium rich food, on vascular health.~   "
46370|NCT02959918|"~     This is an open label multicenter study to evaluate the safety and tolerability of multiple~     doses(3 monthly IV infusions) of SEL-212 ( a combination of pegsiticase( SEL-037) and~     SVP-rapamycin (SEL-110)) followed by multiple doses (2 monthly IV infusions) of pegsiticase~     (SEL-037) alone for a total of 5 treatment cycles in subjects with symptomatic gout and~     hyperuricemia. Additional subjects will be treated with multiple doses( 5 monthly IV~     infusions) of pegsiticase (SEL-037) alone.~      Subjects will be monitored for safety endpoints through the 5th treatment cycle plus 30 days~     .Pharmacokinetic samples will drawn a pre-determined time points in addition to weekly serum~     uric acid levels.~   "
46371|NCT02959905|"~     The primary purpose of this study is to evaluate the safety of TSA-CTL in the treatment of~     the advanced melanoma.~      The secondary purpose of this study is to evaluate preliminarily the effect of TSA-CTL in the~     treatment of the advanced melanoma.~   "
46372|NCT02959892|"~     The purpose of this study is to determine brain penetration of single oral doses of TAK-041~     and its effects on amphetamine-induced dopamine release in the Central Nervous System (CNS).~   "
46373|NCT02959879|"~     In patients with resectable pancreatic duct adenocarcinoma (PDAC), curative surgery followed~     by adjuvant chemotherapy is currently the standard of care. However, the long-term results~     are still poor, with median disease-free and overall survival of 14 months and 23 months. The~     corresponding 5-year overall survival rate is 20%.~      Chemotherapy before surgery (neoadjuvant chemotherapy) allows identification of patients with~     rapidly progressive metastatic disease at time of preoperative restaging (surgery is then~     avoided in these patients), and may increase the rate of free margin resection (R0) and~     reduce the risk of local recurrence.~      Even though single-agent gemcitabine and 5-FU have been validated in adjuvant and metastatic~     settings, the objective response was low (at around 10%), whereas combination chemotherapy~     exceeds a response rate of 30% in advanced disease. In metastatic PDAC, palliative FOLFIRINOX~     chemotherapy has been demonstrated to be effective (in terms of response rates and~     progression-free survival) and well tolerated. Interestingly, the response rate is increased~     by using more than two chemotherapeutic agents in advanced pancreatic cancer, justifying the~     use of an alternative neoadjuvant FOLFOX-based chemotherapy arm.~      PANACHE-01 is an open, non-comparative, randomised, multicentre Phase II study designed to~     assess the safety and efficacy of two modes of neo-adjuvant chemotherapy (FOLFIRINOX &~     FOLFOX) relative to the current reference treatment (surgery and then adjuvant chemotherapy)~     for resectable PDAC.~      Patients with immediately resectable PDAC (definition based on the NCCN's (American National~     Comprehensive Cancer Network 2014) latest guidelines) will be randomised to either~     pancreatectomy and adjuvant chemotherapy or 4 cycles of neoadjuvant chemotherapy with either~     FOLFOX or FOLFIRINOX. The patients in the neoadjuvant chemotherapy arms will receive~     postoperative chemotherapy for 4 months (8 cycles).~   "
46374|NCT02959866|"~     We will evaluate the acceptability, feasibility and impact of an online tool that helps~     patients identify financial benefits that they are entitled to at six clinic sites over a~     three month period. We will answer the following questions: Is an online tool that addresses~     income security feasible and acceptable to clinicians? Can such a tool be integrated into~     regular clinic workflow? What is the patient perspective on the tool and what is the~     short-term impact?~   "
46387|NCT02959697|"~     Blepharoptosis (ptosis) repair is a common and generally well tolerated surgical procedure~     usually performed using local anesthetic. However, a subset of patients appears to experience~     intraoperative pain/discomfort during ptosis repair using an anterior approach with~     subcutaneous local anesthetic. Posterior subconjuctival local anesthetic is currently used~     for eyelid procedures such as chalazion incision and drainage and full-thickness eyelid~     resections. The purpose of this study is to determine whether an additional subconjunctival~     injection of local anesthetic, through the posterior aspect of the eyelid, reduces~     intraoperative pain during anterior ptosis repair.~   "
46453|NCT02958839|"~     To investigate whether fibroblast growth factor 23 can be used to predict recurrence after~     catheter ablation for atrial fibrillation and to provide an objective basis for the clinical~     selection of the optimal patients for catheter ablation.~   "
46375|NCT02959853|"~     After the age of 40, there is a gradual decline in the production of testosterone. Among~     obese men, the decline in testosterone levels is exacerbated by the suppression of the~     hypothalamic-pituitary-gonadal axis by hyperestrogenemia. The high expression of aromatase~     enzyme in the adipose tissue enhances the conversion of androgens into estrogens which in~     turn exert a negative feedback on the hypothalamus and pituitary, leading to the inhibition~     of production of gonadotropin-releasing hormone (GnRH), luteinizing hormone (LH) and follicle~     stimulating hormone (FSH), and as a consequence, of testosterone by the testis resulting in~     hypogonadotropic hypogonadism (HH). Though bone loss is a well recognized side effect of AI~     in certain populations, such as women with breast cancer, HH obese men present high levels of~     circulating estrogens that could potentially prevent them from bone loss, estradiol being the~     main regulator of the male skeleton. This study is designed to determine if aromatase~     inhibitors in combination with weight loss, compared to weight loss alone, will have a~     positive effect on muscle strength, symptoms of hypogonadism, and body composition without~     negatively impacting bone mineral density and bone quality. Results from this study will help~     determine if certain groups of obese patients would benefit from therapy with aromatase~     inhibitors.~   "
46376|NCT02959840|"~     The purpose of this study is to compare the effectiveness of acupressure point P6 stimulation~     versus intravenous ondansetron plus metoclopramide versus no antiemetic prophylaxis during~     elective cesarean section under regional anesthesia.~   "
46377|NCT02959827|"~     This study will estimate the incidence of hypothyroidism in a pediatric population of~     children under age 4, based on data from the US-based Kaiser Permanente Northern California~     database, which were exposed to iodinated contrast agent through having a diagnostic~     procedure.~   "
46378|NCT02959814|"~     Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of~     coronary stenosis. QFR is assessed by calculation of the pressure in the vessel based on two~     angiographic projections. The purpose of the FAVOR II study is to evaluate the diagnostic~     accuracy of on-line QFR compared to 2D Quantitative Coronary Angiography (QCA) with FFR as~     gold standard.~   "
46379|NCT02959801|"~     The purpose of this study was to compare the efficacy of Percutaneous mechanical thrombectomy~     (PMT) followed by standard anticoagulant therapy, with anticoagulation therapy alone, for the~     treatment of acute proximal lower extremity deep vein thrombosis.~   "
46380|NCT02959788|"~     Identification of patients who are at highest risk for heart attack is an important task for~     emergency medicine physicians. Currently, physicians use a variety of different scoring~     systems to stratify their risk for having a heart attack. Heart rate variability (HRV) is a~     measure derived from noninvasive cardiac monitoring. This data is collected from a simple,~     non-invasive chest strap during a 10-minute recording session. The purpose of this proposal~     is to collect heart rate variability data on patients admitted to the emergency department~     with chest pain. The intent is to measure the association between heart rate variability and~     the various risk stratification scoring systems for chest pain.~   "
46381|NCT02959775|"~     Uptake, adherence, and completion of vaccination among drug users were low, and their immune~     function and immune response to hepatitis B vaccination were also suboptimal, indicating that~     the current practice of hepatitis B vaccination can't protect drug users from HBV infection.~      This is a randomized, open-label, blank-controlled trial, conducted among drug users with~     drug rehabilitation. This study will compare the immunogenicity and safety of three~     intramuscular 20µg and 60µg recombinant hepatitis B vaccines at months 0, 1, and 6 among drug~     users~   "
46382|NCT02959762|"~     Animal studies have found that vitamin K-dependent proteins matrix Gla protein and~     osteocalcin beneficially influence lipid and glucose metabolism, respectively. However, this~     concept has not been tested in humans at risk for dyslipidemia and diabetes risk. Vitamin K~     supplementation presents an opportunity to test the hypothesized link between the vitamin~     K-dependent proteins and markers of lipid and glucose metabolism. The investigators will~     conduct an 8-week vitamin K intervention (to manipulate carboxylation of matrix Gla protein~     and osteocalcin) and determine its effects on markers of dyslipidemia and diabetes risk.~     Sixty obese children will be randomly allocated to either the control group receiving placebo~     or the low-dose (45 mcg/d) or high-dose group (90 mcg/d) receiving vitamin K (menaquinone-7).~   "
46383|NCT02959749|"~     Acquired epidermal growth factor receptor (EGFR) T790M mutation is the most common genetic~     change after resistant to first generation EGFR tyrosine kinase inhibitor (EGFR TKI) in~     non-small cell lung cancer. After a 10 to 14 months median progression-free survival with the~     treatment of first generation EGFR TKI, half of patients will get disease progression.For~     patients progression after treated with first line EGFR TKI and second line double bullets~     chemotherapy or chemotherapy then EGFR TKI, optimal third line therapy is quite critical~     important for benefit patients' survival. We conducted this study was aimed to compare the~     efficacy and toxicity between osimertinib and docetaxel-bevacizumab as the third line therapy~     in patients with local advanced or metastatic non-squamous cell lung cancer.~   "
46384|NCT02959736|"~     The purpose of this project is to further develop a standardized music-based measure used in~     music therapy with adults who have emerged from coma following profound brain injury, but are~     not able to demonstrate responsiveness to their environment due to complex clinical needs.~     Building on previous work, the project aims to strengthen the psychometric properties (e.g.~     concurrent validity, responsiveness) of the measure for its use with adults with profound~     brain damage.~   "
46385|NCT02959723|"~     The current aims to combine analysis of different inflammatory biomarkers and BMPR2~     mutations, which are currently analyzed in each patient diagnosed with idiopathic or familial~     PAH, to establish an earlier diagnosis and consequently better orientate the therapeutic~     strategy in PAH.~   "
46386|NCT02959710|"~     To compare serum ketone body (i.e., total ketones, β hydroxybutyrate, and estimate of~     acetoacetate) levels after single dose administration of AC-1204 mixed in water, AC-1202~     mixed in water and AC-1202 mixed in Ensure®.~   "
46388|NCT02959684|"~     To evaluate the efficacy of a new screening for infectious diseases: tuberculosis, HIV, HBV~     and HCV, based on risk factors questionnaires (TB screen for tuberculosis and TROD screen for~     HIV and hepatitis) amongst a population of legal migrants during their mandatory medical~     check-up. This study aims for a global improvement of screening and care for migrants.~   "
46389|NCT02959671|"~     A cohort of 15 patients starting orthodontic treatment with fixed appliances will receive~     EXD-952 Ceramic Self-ligating brackets on all mandibular incisors and a different type of~     brackets on the remaining mandibular teeth. Tooth movement will be initiated using 0.014 or~     0.016 Nickel-Titanium archwires.~      A second cohort of 15 patients will receive EXD-952 Ceramic Self-ligating bracket on all~     mandibular incisors in a later phase of their ongoing orthodontic treatment. The mandibular~     incisor brackets will be removed and EXD-952 Ceramic Self-ligating brackets placed instead.~     Other mandibular brackets will remain in place. Tooth movement will be performed using~     0.019x0.025 Stainless Steel archwires.~      In both cohorts bracket door stability, the ability of the door to hold the archwire in the~     bracket slot, the bracket's ability to rotate teeth, clinicians' satisfaction with the~     bracket, and patient comfort in comparison with other brackets will be assessed.~      The evaluation for each patient will last for at least until one archwire change (cohort 1)~     or one appointment interval (6-8 weeks, cohort 2).~      After the evaluation period, EXD-952 Ceramic Self-ligating brackets will remain in place~     until the orthodontic treatment is completed.~   "
46390|NCT02959658|"~     This study aims to evaluate safety and efficacy of dimethyl fumarate treatment in patients~     with primary progressive multiple sclerosis (PPMS).~      Half of the patients will receive dimethyl fumarate and the other half will receive placebo.~   "
46391|NCT02959645|"~     To address joint position sense in cervical dystonia patients and how it affects the brain~     activity.~   "
46392|NCT02959632|"~     The purpose of this study is to evaluate the common symptoms leading to an Animal Assisted~     Therapy consult, and to measure its (AAT) influence on the symptoms and feelings of~     hospitalized patients.~   "
46393|NCT02959619|"~     This study is aimed to determine the maximum tolerated dose of ensartinib, an oral ALK~     inhibitor in Chinese patients with ALK-positive non-small cell lung cancer~   "
46394|NCT02959606|"~     After endovascular treatment (EVT) for peripheral artery disease (PAD), dual antiplatelet~     therapy (DAAT) of aspirin (ASA) and clopidogrel are currently drug of choice to prevent~     occlusion. Anplone SR®, controlled-released Sarpogrelate hydrochloride, has been introduced~     as an anti-platelet agent for the drug of PAD. The aim of this study was to compare the~     efficacy and safety of Anplone + aspirin and clopidogrel + aspirin in patients who underwent~     EVT for femoro-popliteal occlusive disease.~   "
46395|NCT02959593|"~     To determine the relationship between the affects of viewing commercially available content~     through the VISIOR video goggles and ocular blood flow in glaucoma patients and healthy~     subjects.~   "
46396|NCT02959580|"~     This study evaluates the clinical response rate of topical steroids in the treatment of~     idiopathic granulomatous mastitis in female adults. Half of the participants will receive~     topical steroid and the other half will receive local wide surgical excision.~   "
46397|NCT02959567|"~     Evaluation of efficacy and safety of using Aqueduct -100 - Cervical Dilator Device, focusing~     on diagnostic or operative hysteroscopies.~   "
46398|NCT02959554|"~     This study aims to assess the survival benefit from an early switch approach from sunitinib~     or pazopanib (10-12 weeks of 1st-line therapy) to nivolumab (anti-angiogenic to immunotherapy~     switch).~   "
46399|NCT02959541|"~     This is an open randomized single site Pharmacokinetic and Pharmacodynamic study,of~     Calciumfolinat 60 mg/m², 200 mg/m² or 500 mg/ m² in blood, tumor and adjacent mucosa from~     patients with colon cancer~   "
46400|NCT02959528|"~     Previous studies indicated that children with attention-deficit/hyperactivity disorder (ADHD)~     often suffer from deficits in executive function, such as attentional control, inhibition,~     and working memory. One of these executive functions, working memory, plays a critical role~     in academic performance and classroom behavior. Working memory is essential for performing~     complex cognitive tasks such as comprehension, learning, and reasoning. Several studies have~     shown that training of working memory has positive effects for ADHD and other cognitive~     disorder in children. However, transfer effects across studies appear to be variable and~     inconsistent. Event-related potentials can be a useful tool to gain insights into such~     mechanism. Therefore, the aim of the present study is to investigate both near and far~     transfer effects of N-back training in children with ADHD. In addition, the recording and~     analysis of event-related potentials will be adopted while children with ADHD perform the~     complex visuo-spatial and phonological working memory tasks.~   "
46401|NCT02959515|"~     The aim of this study is the comparison of oxygen delivery during OLV+capnothorax and~     OLV+capnothorax and CPAP.~   "
46402|NCT02959502|"~     The overall goals of this project are to assess the feasibility and impact of designing and~     implementing an at-home intervention aimed at preventing long-term cognitive decline and~     improving cognition in individuals currently at-risk for developing AD.~   "
46403|NCT02959489|"~     This study is intended to examine the impact of learning amyloid brain imaging results among~     asymptomatic older adults, and how to safely communicate these results and educate on the~     risk of developing Alzheimer's disease.~   "
46404|NCT02959476|"~     This study evaluates a Ropivacaine 0.2% Pre-Filled Dispenser in the treatment of~     post-surgical pain in patients undergoing Cesarean delivery. Half of the patients will~     receive Ropivicaine and half will receive placebo.~   "
46405|NCT02959463|"~     The goal of this clinical research study is to assess the safety of pembrolizumab (also~     called MK-3475) after radiation therapy (with or without surgery and/or chemotherapy) in~     patients with MPM.~      This is an investigational study. Radiation therapy is delivered using FDA-approved and~     commercially available methods for local control of metastatic and primary tumors.~     Pembrolizumab is FDA approved and commercially available for the treatment of unresectable or~     metastatic melanoma, and for lung cancer. Its use in this study is investigational.~      Up to 24 participants will take part in this study. All will be enrolled at MD Anderson.~   "
46406|NCT02959450|"~     The purpose of this trial is to design, implement and evaluate the effect of a nutritional~     intervention in patients with Oropharyngeal Dysphagia on body composition and oral intake of~     energy and protein.~   "
46435|NCT02959073|"~     In the last decades the prevalence of allergies has reached epidemic proportions. 10 to 15%~     of the population suffers from cat allergy. Investigators perform this study in order to~     further investigate symptom records and their evaluation in cat allergic patients.~      Investigators primarily aim to better standardize the symptom recording of cat allergic~     persons under real-life conditions and to evaluate the effect of hypoallergenic cats on~     symptom strength.~   "
46407|NCT02959437|"~     This is an open-label, Phase 1/2 study in subjects with advanced or metastatic solid tumors.~     The study has three separate treatment groups where separate epigenetic agents are evaluated~     with an immunotherapy combination. Treatment Group A will evaluate the DNA methyltransferase~     inhibitor azacitidine in combination with the programmed death receptor-1 (PD-1) inhibitor~     pembrolizumab and the indoleamine 2,3-dioxygenase (IDO-1) inhibitor epacadostat; Treatment~     Group B will evaluate the bromodomain and extra-terminal (BET) inhibitor INCB057643 with~     pembrolizumab and epacadostat; and Treatment Group C will evaluate the lysine-specific~     demethylase 1A (LSD1) inhibitor INCB059872 with pembrolizumab and epacadostat. The study will~     be divided into 2 parts (Part 1 and 2). Part 1 is a dose-escalation assessment to evaluate~     the safety and tolerability of the combination therapies. Once the recommended doses have~     been determined, subjects with previously treated NSCLC, microsatellite-stable colorectal~     cancer (CRC), head and neck squamous cell carcinoma, urothelial carcinoma, and melanoma will~     be enrolled into expansion cohorts in Part 2.~   "
46408|NCT02959424|"~     Chronic esophageal disorders affect approximately one third part of global population, with a~     deleterious impact in the quality of life of patients. Measured of health related quality of~     life in chronic esophageal conditions such as gastroesophageal reflux disease and achalasia~     are widely used to measure this important patient-reported outcome. The Northwestern~     Esophageal Quality of Life (NEQOL) is a hybrid measure of esophageal illness, allowing for~     broad use across esophageal diseases while maintain sensitivity to nuances of a specific~     condition. The NEQOL is a reliable and valid hybrid measure of disease specific health~     related quality of life across several chronic esophageal conditions. The Ecuadorian~     Institute of Digestive Diseases aims to translate and validate this survey into Spanish for~     its use in a Hispanic population. This cross-sectional study aims to translate, apply and~     validate the NEQOL in the patients attending in the esophageal division of the institute.~   "
46409|NCT02959411|"~     This study will clarify the clinical usefulness of Tolvaptan therapy in patients with~     complicated acute decompensated heart failure and hyponatremia (low blood sodium).~   "
46410|NCT02959398|"~     Tomosynthesis is an innovative technique developed in digital mammography for obtaining a~     sectional image of the breast. Mammography has the main disadvantage of being an imaging~     projection that creates overlays, which eliminates tomosynthesis.~      The objective of this study is to evaluate if the BI-RADS classification obtained by~     tomosynthesis with synthetic mammography is superior to that obtained by conventional~     mammography in terms of specificity while not inferior in terms of sensitivity.~   "
46411|NCT02959385|"~     Neoadjuvant chemoradiotherapy(Neo-CRT) plus surgery has been regarded as a standard of care~     for patients with resectable locally advanced oesophageal cancer. Many studies suggest that~     definitive Radiochemotherapy(CRT) has similar efficacy as neoadjuvant chemoradiotherapy plus~     surgery for esophageal cancers who respond to chemoradiation. Herein, a single center~     prospective randomized phase II clinical trial will be carried out to compare efficacy and~     safety of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical~     resection in patients who achieved clinical complete response(CCR) after neoadjuvant~     radiochemotherapy for stage II-III esophageal Cancer.~   "
46412|NCT02959372|"~     Introduction: Despite the great advances in treatment, heart failure (HF) continues to be an~     important health problem because of its high prevalence, morbidity, mortality and associated~     costs. Research shows at least 40% of HF in-patients are going to be readmitted in the~     following year. Thus, new strategies to reduce HF decompensations are needed.~      In recent studies, pulmonary congestion which is expressed in the form of B-lines detected by~     lung ultrasound (LUS) has proven to be a potent prognostic predictor of hospitalization and~     mortality in HF. Moreover, the use of LUS is becoming more common due to its availability~     (with pocket devices with sizes approaching those of smart phones); its simplicity (rapid~     learning curve and rapid examination, less than 5 minutes) and its safety (radiation free).~      We hypothesize that a management guided by LUS in HF patients may improve outcomes.~      Objective: The aim of our study is to evaluate if ambulatory LUS guided treatment of patients~     after a hospitalization for HF, decreases the combined end-point of mortality or~     re-hospitalization after a 6 months follow-up.~      Study design: The design of our study is a randomized, simple blinded, clinical trial.~      Eligible patients are patients older than 18 years of age who have been hospitalized for HF.~     The exclusion criteria are life expectancy of less than 6 months or uninterpretable lung~     ultrasound. Eligible patients are going to be randomized into either the LUS group or the~     control group.~      The follow-up consists of visits to the HF clinic at periods of 15 days, 1, 3 and 6 months~     after the initial hospitalization. LUS is going to be performed on all patients despite their~     respective group. Only in relation to the LUS group, the treating physician will have the~     result of the examination and the subsequent treatment adjustment could be made in response~     to those findings.~      This study complies with the Declaration of Helsinki and the study protocol is being~     evaluated by the Ethic Committee of our institution.~   "
46413|NCT02959359|"~     For early stage of HCC, surgical resection or radiofrequency ablation (RFA) is the mainstay~     curative treatments. However, recurrence is still a major issue after the surgery or RFA.~     Only selected patients are eligible and tolerable to IFN-based treatment after surgical~     resection and the sustained virological response varied.~      Harvoni for genotype 1 HCV and sovaldi plus ribavirin for genotype 2 HCV can achieve high SVR~     and being recommended by AASLD and EASL. Mixed HCV genotype infection accounts for 10% of CHC~     patients in Taiwan. Sovaldi-based treatment plus ribavirin should be as effective as Sovaldi~     plus rivavirin in the treatment of genotype 2 HCV, as well as mixed genotype 1 and 2 HCV~     infection. As genotype 1 and 2 are the leading HCV genotypes in Taiwan, It can simplify the~     regimen of anti-HCV treatment in Taiwan by using Harvoni plus ribavirin, not only for~     genotype 1 and 2 HCV but also for mixed genotype 1 and 2 HCV infection. Although an~     unexpected high recurrence rate in HCC patients under DAA treatment was reported once.~     However, one recent study showed a low risk of HCC recurrence after DAA treatment. In this~     study, the investigators plan to enroll 130 HCV-HCC patients after confirming curative~     treatment for their HCC, either by surgery or RFA. For the cases fulfilling the~     inclusion/exclusion criteria, a 12 weeks Harvoni plus ribavirin treatment will be provided~     for all cases (single armed design). The primary objective of the study is annual~     recurrence-free survival after curative resection of HCV-HCC for up to 5 years. A~     hospital-based cohorts of HCV-related HCC undergoing surgical resection or RFA from Taipei~     Veterans General Hospital and Investigated Sites will be recruited as historical controls.~   "
46436|NCT02959060|"~     This study is to evaluate the effect of rifampin on the single-dose pharmacokinetics (PK) of~     BMS-986177 in healthy participants with parameters like Cmax, AUC(INF), AUC(0-T)~   "
46454|NCT02958826|"~     The purpose of this study is to determine the effect surgical lights, surgical smoke, and~     surgical sounds have on patient satisfaction with their outpatient Mohs surgical procedure.~   "
46414|NCT02959346|"~     Minimal invasive thoracoscopic surgery has been used widely for common thoracic diseases in~     recent years. Patients who received thoracoscopic surgery recovered much quickly and returned~     to their daily life sooner because of small operation wound and less invasion. However,~     operative pain was still an important factor, which might contribute to several~     post-operative complications.~      In daily practice, patients received oral/intravenous form non-steroidal anti-inflammatory~     drugs and opioid agents, or patient-controlled analgesia for post operative pain control.~     However, some side effects were observed occasionally.~      The role of acupuncture in post-operative pain control was frequently discussed in recent~     research. The main mechanisms of acupuncture in pain control were (1) to stimulate the~     release of endogenous opioid and (2) to block TRPV1 receptor.~      The randomized controlled trial arranged by Gary Deng and his colleagues in 2008, was the~     first clinical trial investigated the role of acupuncture in post-operative pain control for~     traditional thoracotomy patients. However, there was no further research about the role of~     acupuncture applied to minimal invasive thoracoscopic surgery.~      Thus, the aim of this randomized controlled trial was to investigate the role of acupuncture~     in post-operative pain control for minimal invasive thoracoscopic surgery patients. In order~     to deliver a safe and effective way in pain control, and to save medical cost and promote~     quality of patient care.~   "
46415|NCT02959333|"~     Bronchial fistula (BF), an abnormal passage or communication between a bronchus and another~     part of the body, may develop when there are penetrating wounds of the thorax and after lung~     surgery. Without effective therapy, treatment of BF is a challenge, with a high rate of~     mortality and teratogenicity.~      The investigators will conduct endoscopic injection of human amniotic epithelial cells to~     fistula, observe the recovery of bronchial fistula and systemic reactions, to investigate the~     application of human amniotic epithelial cells in the treatment of bronchial fistula.~   "
46416|NCT02959320|"~     Displaced femoral neck fractures are one group of hip fracture patients that are commonly~     treated with cemented hemiarthroplasty (HA) or total hip arthroplasty (THA). In the elective~     hip arthroplasty population, the direct anterior approach (DAA) has shown to be effective in~     helping patients to quickly obtain high postoperative function. This approach has also been~     shown to be effective in arthroplasty for displaced femoral neck fractures in a few studies.~     However, the only studies that directly compare two approaches for hip arthroplasty for~     femoral neck fractures utilize the anterolateral approach (ALA) versus posterior approach~     (PA) or DAA versus PA. No studies of which we are aware directly compare the DAA to the ALA.~     The DAA and ALA are the two most popular approaches for bipolar hemiarthroplasty at our~     institution, so we are setting out to determine the differences between them.~   "
46417|NCT02959307|"~     Transcranial Light Therapy involves non-invasive and invisible beams of light that increase~     energy metabolism in the brain. Transcranial light therapy has been found to promote brain~     metabolism which may help people with depression. The research team proposes a novel approach~     to treating depression by using transcranial light therapy.~   "
46418|NCT02959294|"~     Concussion is the most common type of brain injury throughout life. Study is seeking~     improvement of long-term residua following adolescent and adult post-traumatic injuries often~     associated with contact sports and accidental causes. Typically defined as reversible head~     injury with temporary loss of brain function. Symptoms range from physical, cognitive, pain~     (headache) and emotional signs consistent with TBI and Post-Traumatic Stress Syndrome. Use of~     AD-cSVF parenteral delivery to encourage repair of damage and decreased function following~     concussion, particularly in contact, repetitive sports injuries. Range of damage is measured~     in Grade I-III according to graduated severity. Unfortunately, less information is available~     about repetitive concussions and the long-term health issues.~   "
46419|NCT02959281|"~     The purpose of this study is to investigate whether hemodynamic data obtained by a~     noninvasive bio-impedance system (NICAS) sampled from patients with cardiorenal syndrome type~     I (CRS1) improve clinical outcomes. We hypothesize that hemodynamic data provided to the~     caring physician will improve management of CRS1 patients.~   "
46420|NCT02959268|"~     This is a Prospective open-label, comparative pivotal study with comparison of~     self-assessments with blinded investigator assessments. Pregnant women attending the labor~     and delivery unit of the hospital or emergency clinic and reporting unidentified wetness~     (undetermined whether this is amniotic fluid leakage or urinary incontinence) will be~     enrolled in this study. After informed consent is obtained, each subject will be given a~     single AL-SENSE to use up to 12 hours or until the perception of wetness.~      Product Usage~      After usage, the subject will read and record any occurrence of color change of the AL-SENSE~     10 minutes after the liner removal and to mark if it changes color to blue or to green or not~     on the designated form. The subjects will fill out the questionnaire regarding the product~     usage experience and the liner color reading with no help from the investigator, to validate~     IFU reading comprehension. A blinded clinician will perform a standard clinical diagnosis~     (clinical assessment). The standard clinical diagnostic methods will include the following~     tests: (1) Pooling test, (2) Ferning test, (3) pH test by pH paper. A positive Pooling test~     and/or positive results in both the pH test and the Ferning test will be defined as a~     positive clinical test result.~   "
46437|NCT02959047|"~     Peripheral arterial disease (PAD) is characterized by lower limb arterial obstruction due to~     atherosclerosis. Magnetic resonance imaging (MRI) methods can accurately quantify~     atherosclerotic plaque in the superficial femoral artery (SFA) in patients with PAD. Such~     techniques have demonstrated plaque regression with statin therapy over 1 year. Alirocumab is~     a PCSK9 inhibitor that effectively reduces LDL cholesterol up to 70% in patients on statins~     or intolerant to statins. The investigators hypothesize that effective low density~     lipoprotein (LDL) lowering with Alirocumab 150m subcutaneously (SQ) every 2 weeks will~     regress atherosclerotic plaque in the SFA in patients with PAD over one year compared to~     placebo. 54 patients with mild-moderate PAD (ankle brachial index or ABI 0.4-0.9) will be~     randomized to alirocumab 150 mg SQ every 2 weeks or matching placebo at the University of~     Virginia (UVA) (n=34) and Northwestern (n=20). The primary endpoint is change in~     atherosclerotic plaque volume in the superficial femoral artery over the 1 year treatment~     period. Secondary endpoints include changes in peak calf muscle perfusion after thigh cuff~     occlusion/hyperemia, 6-minute walk distance, and blood biomarkers (LDL cholesterol,~     fibrinogen, high sensitivity c-reactive protein (hs-CRP), and lipoprotein(a).~   "
46421|NCT02959255|"~     Helicobacter pylori (H. pylori) infection is highly associated with gastrointestinal~     disorders, including peptic ulcer disease, gastric cancer, and gastric mucosa associated~     lymphoid tissue lymphoma.1 In 1994, H. pylori was classified as a group carcinogen by the~     International Agency for Research on Cancer. Since then, many consensus conferences and~     clinical guidelines worldwide have been established for the treatment of H. pylori infection.~      Despite H. pylori infecting an estimated 50% of the global population,there is no universally~     effective regimen in everyday clinical practice. The current European Helicobacter Study~     Group Guidelines for the first line empirical treatment of the H. pylori infection propose a~     variety of treatment strategies, as optimal treatment of H. pylori infection requires careful~     attention to local antibiotic resistance and eradication patterns. Most recently, the Toronto~     Consensus for the Treatment of Helicobacter pylori Infection in Adults strongly recommended~     that all H. pylori eradication regimens now be given for 14 days. Recommended first-line~     strategies include concomitant nonbismuth quadruple therapy (proton pump inhibitor [PPI] +~     amoxicillin + metronidazole + clarithromycin [PAMC]) and traditional bismuth quadruple~     therapy (PPI + bismuth + metronidazole + tetracycline [PBMT]).The aforementioned statement by~     an international working group of specialists chosen by the Canadian Association of~     Gastroenterology is of the outmost importance, especially in countries with increased~     antibiotic resistance, like Greece, with resistance rates >20% to clarithromycin and >40% to~     metronidazole.~   "
46422|NCT02959242|"~     To assure the quality of follow-up and treatment, data of glaucoma patients are stored and~     evaluated after anonymisation.~   "
46423|NCT02959229|"~     The present study was designed to evaluate the effectiveness of oral lactoferrin in~     prevention of neonatal sepsis with comparison early (1st day) versus late (48-72 hours)~     Lactoferrin administration, Secondary aim was to study effect of Lactoferrin administration~     on serum Ferritin and follow up long term outcome (Bronchopulmonary dysplasia, retinopathy of~     prematurity and necrotizing enterocolitis.~   "
46424|NCT02959216|"~     This study evaluates the efficacy of aerobic exercise in the acute phase of recovery for~     pediatric patients with a concussion. Half of participants will complete sub-symptom~     threshold aerobic exercise and half of participants will complete a placebo stretching~     protocol.~   "
46425|NCT02959203|"~     Background:~      Insertion of a central venous catheter (CVC) could lead to a variety of complications.~      To detect those complications, Chest X-ray (CXR) is still the reference standard. However,~     there are major limitations in performing CXR's in the critical care setting.~      Aim/objectives:~      The objective of this study is to compare the use of bedside ultrasound (US) to conventional~     CXR in visualization of accuracy and safety of the CVC placement. The aim is to eventually~     replace X-ray with bedside ultrasound as gold standard for the confirmation of CVC-placement~     in critically ill patients, thereby reducing radiation exposure and unnecessary delay before~     CVC use.~      Methods:~      The bedside US will be performed by the student or attending physician, who is blinded for~     CXR findings. After US examination, the attending physician (or student) will fill in a~     structured form, based on an established protocol. CXR will be performed before or after US~     examination and assessed by a radiologist. The radiologist will be blinded for the findings~     of the bedside ultrasound to prevent any biases. Final diagnosis will be determined after~     examination of the complete medical chart.~   "
46426|NCT02959190|"~     The main purpose of this study is to evaluate the safety and effectiveness of the study drug~     known as Galcanezumab in Japanese participants with migraine.~   "
46427|NCT02959177|"~     The main purpose of this study is to determine the efficacy of the study drug Galcanezumab in~     Japanese participants with episodic migraine.~   "
46428|NCT02959164|"~     The purpose of this Phase 1b study is to assess the safety and maximum tolerated dose (MTD)~     of Decitabine in combination with Gemcitabine among previously treated patients diagnosed~     with advanced pancreatic adenocarcinoma or sarcoma (soft tissue and bone).~   "
46429|NCT02959151|"~     The purpose of this study is to collect the date on the safety and potential effectiveness of~     CART cells combined with interventional therapy in patients with advanced liver malignancy.~   "
46430|NCT02959138|"~     The primary objective of this study is to evaluate the pharmacokinetics (PK) of GS-9876 in~     participants with impaired renal function relative to matched healthy controls. Participants~     in this study will be enrolled using an adaptive design that includes up to 3 enrolled~     cohorts. Based on safety and/or PK data in Cohort 1, participants will be enrolled in~     adaptive Cohorts 2 and/or 3.~   "
46431|NCT02959125|"~     This study evaluates the intervention of Nut Fish based food, micro nutrients supplementation~     and pregnancy class to improve maternal and birth outcome. This is cluster randomized trial~     with two arms. The intervention group will receive Nut Fish based supplementation, multiple~     micro nutrients, and pregnancy class. The control group will receive government food~     supplementation, iron folic acid supplementation, and pregnancy class.~   "
46432|NCT02959112|"~     Endoscopic retrograde cholangiopancreatography (ERCP) complications occur in 5 to 10% of~     cases, post ERCP pancreatitis is the most common, it is a complication with significant~     morbidity, occasional mortality and high costs. In the prevention of post-ERCP pancreatitis~     have been used various treatments, NSAIDs and pancreatic stent are the most useful, however,~     despite its use, post ERCP pancreatitis continues to affect 10 to 15% of patients with high~     risk. Epinephrine sprayed on the papilla may decrease the edema and prevent the development~     of this complication.~   "
46433|NCT02959099|"~     The Incident COronary EveNts Identified by Coronary Tomography (ICONIC) trial is a nested,~     case-control study derived from the dynamic CONFIRM registry, and is based on propensity~     scoring methods to match subjects with (cases) or without (controls) acute coronary syndrome~     (ACS). Our primary objective is to determine CCTA-based atherosclerotic plaque~     characteristics that would help elucidate precursors of incident ACS, with the secondary~     objective being an analysis of gender-specific disparities.~   "
46434|NCT02959086|"~     The purpose of this study is to describe the morbidity, mortality, disability and survival~     rate in Shanghai adolescents and children with cancer diagnosed since January 2002.~   "
46438|NCT02959034|"~     The aim of this project is to establish a bio-repository of diverse specimen types to provide~     investigators access to specimens in order to further research related to metabolism and the~     microbiome in the pediatric population.~   "
46442|NCT02958982|"~     RP3128 is a calcium release activated calcium (CRAC) channel modulator. The purpose of this~     study is to evaluate the safety, tolerability and pharmacokinetics of single and multiple~     ascending dose(s) of RP3128 in healthy volunteers and to evaluate the effect on late phase~     asthmatic response to allergen challenge in patients with mild asthma.~   "
46443|NCT02958969|"~     Patients living with multiple myeloma (MM) have an increased risk of venous thromboembolism~     (VTE) due to the disease itself and the use of targeted therapies, including immunomodulatory~     drugs (IMiDs). Prevention of VTE has become a major management challenge during MM treatment.~     There is a paucity of data with respect to the non-vitamin K oral anticoagulants (NOACs) in~     the cancer population. However, the NOACs offer comparable efficacy but improved safety~     compared with warfarin. Apixaban has shown excellent safety and efficacy for treatment and~     prevention of recurrent VTE (1,2). The safety and efficacy of apixaban for primary prevention~     of VTE in MM patients has not been established.~      Aim #1: To quantify the 6-month rate of major and clinically relevant non-major bleeding in~     MM patients receiving IMiDs who are prescribed apixaban 2.5 mg orally twice daily for primary~     prevention of VTE.~      Hypothesis #1: The 6-month rate of major and clinically relevant non-major bleeding in MM~     patients receiving IMiDs who are prescribed apixaban 2.5 mg orally twice daily for primary~     prevention of VTE will be ≤3% (2). Although the MM population, in general, has a higher~     medical acuity than that of the previous large randomized controlled trials of apixaban, we~     will be selecting a stable population of MM patients who are appropriate for immunomodulatory~     therapy.~      Aim #2: To quantify 6-month rate of symptomatic VTE in MM patients receiving IMiDs who are~     prescribed apixaban 2.5 mg orally twice daily for primary prevention of VTE.~      Hypothesis #2: The 6-month rate of symptomatic VTE in MM patients receiving IMiDs who are~     prescribed apixaban 2.5 mg orally twice daily for primary prevention of VTE will be <7% (3).~     Although additional therapies for MM such as dexamethasone and erythropoietin-stimulating~     agents may further increase the risk of VTE, the rate of incident VTE should be reduced to~     <7% with apixaban.~   "
46444|NCT02958956|"~     The purpose of this study was to evaluate whether treatment with pioglitazone is associated~     with risk of incident cancer at the 10 most common sites in a cohort of participants with~     recognized diabetes.~   "
46445|NCT02958943|"~     Atrial fibrillation (AF) is the most preventable cause of stroke. However, despite widely~     available risk stratification tools, five options for oral anticoagulation, and~     evidence-based practice guidelines, anticoagulation for stroke prevention in AF is~     consistently under-prescribed. Data from our center (Brigham and Women's Hospital [BWH]) (1)~     demonstrate that fewer than 50% of outpatients with AF at high-risk for stroke according to~     2012 Focused Update of the European Society of Cardiology Guidelines for the Management of AF~     (2) receive anticoagulation.~      Aim #1: To determine the impact of electronic alert-based computerized decision support (CDS)~     on prescription of anticoagulation in high-risk AF patients in the outpatient setting who are~     not being prescribed anticoagulation for stroke prevention.~      Hypothesis #1: Electronic alert-based CDS will increase prescription of anticoagulation by~     80% in high-risk AF patients in the outpatient setting who are not being prescribed~     anticoagulation for stroke prevention.~      Aim #2: To determine the impact of electronic alert-based computerized decision support (CDS)~     on the frequency of stroke and systemic embolic events in high-risk AF patients in the~     outpatient setting who are not being prescribed anticoagulation for stroke prevention.~      Hypothesis #2: Electronic alert-based CDS will reduce the frequency of stroke and systemic~     embolism in high-risk AF patients in the outpatient setting who are not being prescribed~     anticoagulation for stroke prevention. Data acquired through this study regarding the~     frequency of stroke and systemic embolism will be used to calculate sample size requirements~     for a future clinical end-point driven randomized controlled trial of electronic alerts to~     prevent stroke in high-risk AF patients.~   "
46446|NCT02958930|"~     The purpose of this study is to determine the safety and initial efficacy of Transcranial~     Electromagnetic Treatment (TEMT) in patients with mild/moderate Alzheimer's Disease.~     Throughout a 2-month treatment period, patients will be evaluated for cognitive performance,~     brain energy utilization, functional brain imaging, and blood/cerebrospinal fluid (CSF)~     markers for Alzheimer's Disease. Since all patients will receive TEMT, each patient's~     baseline measurements will serve as their own control for any treatment effects.~   "
46447|NCT02958917|"~     Patients are being offered participation in this pirfenidone trial because They have been~     diagnosed with fibrotic hypersensitivity pneumonitis (FHP), a type of interstitial lung~     disease (ILD). This is a disease where scarring of lung tissue occurs as the result of~     inhaling substances called antigens. These antigens can be substances such as molds,~     chemicals or dust. As a result of this scarring the lungs are is not able to move oxygen into~     the bloodstream to reach other organs.~      Currently over 1400 subjects have been treated with pirfenidone in 15 clinical trials. This~     drug has been approved by the Food and Drug Administration (FDA) for use in Idiopathic~     Pulmonary Fibrosis, a different type of ILD, but requires special permission for use in your~     condition. The use of pirfenidone has not been approved for the treatment of FHP. It is~     considered experimental treatment in this study.~   "
46448|NCT02958904|"~     Aims: assess the relationship between sexual function and depressive symptoms in individuals~     with spinal cord injury.~   "
46449|NCT02958891|"~     An epidemiological survey for prevalence description of dental morbidity (caries, gingivitis,~     dental trauma and fluorosis) among Israel Defense Forces (IDF) general recruits. Morbidity~     measures were collected from 700 recruits at their first day of military service in order to~     evaluate extent and burden of dental diseases among recruits. The data will enable the~     military dental services commanders to plan and implement dental services according to the~     dental needs.~   "
46450|NCT02958878|"~     Double blinded, randomized controlled prospective study looking at 2 preoperative doses of~     Tamsulosin an alpha-adrenergic blocker in preventing post-operative urinary retention. A~     previous study was conducted called Effectiveness of tamsulosin inprevention of~     postoperative urinary retention: a randomized double-blind-placebo controlled study This~     study involved a tertiary care center involving mostly urological surgical procedures. We~     look to specifically look at inguinal hernia surgeries in males. The aim of this study is to~     compare the prophylactic effect of tamsulosin with placebo on postoperative urinary~     retention. The drug is FDA approved for benign prostatic hypertrophy and urinary retention.~     It is on formulary at Genesys. Currently there is no standard procedure of prophylactic~     tamsulosin for urinary retention. Most often post operative patients are given tamsulosin to~     augment smooth muscle relaxation and spontaneous voiding if the patient is having urinary~     retention post operatively. We often straight catheterize patients once and start tamsulosin~     with the goal of avoiding urinary retention and future straight catheterizations or placement~     of foley catheters~   "
46451|NCT02958865|"~     The purpose of this study is to determine whether PF-06651600 and PF-06700841 are effective~     in treatment of moderate to severe ulcerative colitis.~   "
46452|NCT02958852|"~     A Clinical Trial to Compare Efficacy and Tolerability of Atorvastatin in Addition to~     Endocrine Treatment with Focus on Mechanisms of Resistance to Endocrine Treatment~     (fulvestrant/aromatase inhibitors) in Patients With Advanced Breast Cancer.~   "
46455|NCT02958813|"~     This study has three specific aims:~        1. To conduct a 2-arm randomized controlled trial comparing IMARA to a family-based health~          program (FUELTM). The investigators will:~           a. Randomly assign 300 14-18 year-old AA or black girls and their primary female~          caregivers to IMARA (N=150) or FUELTM (N=150). Women and girls will be recruited four~          ways: 1) from mental health clinics using clinic liaisons, 2) flyers will be posted in~          clinic recruitment sites and other agencies instructing interested families to call our~          recruiter, 3) IMARA participants will hand flyers to interested women and girls they~          know, and 4) COIP field station staff will pass out flyers and recruit interested women~          and girls at the field stations and in the community. Investigators will examine the~          effects of IMARA on women and girls' sexual behavior at 6- and 12-months.~        2. To evaluate the impact of IMARA on theoretical mediators posited by the Theory of Gender~          and Power and the Social-Personal framework associated with AA women and girls' risky~          sex. Investigators will:~             1. Assess changes in women and girls' Individual Attributes (HIV/AIDS knowledge,~               attitudes, and beliefs, mental health/emotion regulation, ethnic identity); Peer~               and Partner Processes (partner characteristics, relationship power dynamics, peer~               influences, partner communication); and Family Context (mother-daughter~               relationship and communication, parental monitoring) at baseline and follow-ups.~             2. Evaluate mediation and moderation of theoretical mechanisms on women and girls'~               sexual behavior.~        3. To assess the impact of IMARA compared to FUELTM on sexually transmitted infections~          (STIs). Investigators will:~             1. Test women and girls' urine for three common STIs at baseline and 12-month follow~               up.~             2. Explore linkages between biological outcomes and targeted mediators and moderators~               of change.~   "
46456|NCT02958800|"~     Aggressive behaviours in long-term care (LTC) is a difficult health care issue to manage. One~     method that has been over-used is the prescription of antipsychotics for the behaviours and~     psychological symptoms of dementia (BPSD). This high prevalence of use is a recognized health~     care problem in Ontario and around the world; increased antipsychotics use is associated with~     increased falls and mortality. Existing strategies are educational in nature and are not~     systematic; the goal of this study is to develop a systematic algorithm to help LTC~     physicians deprescribe and taper antipsychotics safely and effectively.~      The objectives of the study is to: 1) Develop a discontinuation algorithm for antipsychotics~     based on single patient open-label (SPOT) trial methodology (e.g. a variation of N-of-1~     trials) with standardized outcome measures for LTC physicians; 2) To pilot a clinical~     pharmacist-led recruitment strategy; 3) To provide preliminary evidence to demonstrate that~     this algorithm could lead to deprescribing of anti-psychotic medications in LTC.~   "
46457|NCT02958787|"~     Prostate cancer patients have a number of excellent treatment options to consider, and~     quality of life following treatment is often a consideration in treatment choice. One~     critical quality of life concern for patients diagnosed with prostate cancer is sexual~     function. Previous studies point to a vascular mechanism of impotence post-radiation therapy,~     as opposed to a nerve-based mechanism following surgery. In this study, the critical vascular~     structures (internal pudendal artery and corpus cavernosum) are defined by MRI-based imaging~     and included in treatment planning for radiation treatments, hopefully preserving critical~     artery function. This study will collect erectile function preservation rates at 5-years~     post-vessel-sparing radiotherapy with or without aids using the patient reported using the~     simplified three-question erectile function scale.~   "
46458|NCT02958774|"~     The primary objective of this study is to document lymphedema rates in patients requiring~     regional nodal irradiation (RNI) who receive hypofractionated radiation as compared to~     conventional radiation.~   "
46459|NCT02958761|"~     Primary aim of this trial was to assess efficacy three intraarticular injections of platelet~     lysate when compared to hyaluronic acid. Additional objectives were to compare the treatment~     groups in terms of a number of functional scales and of number of adverse events.~   "
46460|NCT02958748|"~     To evaluate change of different immune cellsduring ARDS and its impact on prognosis.~   "
46461|NCT02958735|"~     The purpose of this study is to determine whether an acute bout of exercise may temporarily~     enhance cognitive function (such as memory or attention span) by measuring behavioral~     performance on cognitive tests, as well as expression of hormones in circulation associated~     with brain plasticity and stress.~   "
46462|NCT02958722|"~     The investigators aim to enroll 2000 patients to undergo diagnostic hysteroscopy for~     suspected uterine pathologies. Women will be randomized into two groups on the basis of~     distension medium : group A CO2; group B physiological solution. Pain discomfort will be~     evaluated after the examination.~   "
46463|NCT02958709|"~     In this open-labeled, randomized clinical trial, the Investigator will assess the safety and~     pharmacokinetics (PK) of model-optimized doses of rifampicin (RIF) with or without~     levofloxacin (LEVO) given to children as part of multidrug treatment for tuberculous~     meningitis (TBM) versus standard treatment. The Investigators will also assess functional and~     neurocognitive outcomes by treatment group, as measured by the Pediatric Modified Rankin~     Score (MRS) and the Mullen Scales of Early Learning (MSEL), respectively.~   "
46464|NCT02958696|"~     HTL0018318 is a selective muscarinc M1 agonist. This study is a phase I, open label,~     randomised, crossover, single dose, trial in healthy volunteers to compare the relative~     bioavailability of HTL0018318 when given by oral aqueous solution and in capsule formulation.~   "
46465|NCT02958683|"~     Breathing movements, called chest wall motion, are very complex. The investigators are~     studying how movement of the abdomen, ribs and diaphragm contribute to breathing and how this~     differs with different diseases in the chest. Breathing movements may help with diagnosis,~     assessment of severity or assessing the impact of treatments for chest conditions. The~     investigators are following people who have a chest disease, measuring their chest wall~     motion and comparing it to their diagnosis and and how their treatment works.~      Chest wall motion can be measured in different ways at rest and whilst exercising. Small~     stickers on the chest can be used to reflect infra red light or visible squares of light can~     be shone onto the chest without using stickers.~   "
46466|NCT02958670|"~     Cerebral accumulation of tau and beta-amyloid are major factors of Alzheimer's disease~     pathology. A novel Positron Emission Tomography (PET) tracer (18-F-AV-1451) now offers the~     ability to study tau protein deposition in vivo in subjects, in which information on cerebral~     amyloid deposition has already been gathered. This enables to study effects of tau deposition~     on neuronal integrity, their relation to effects of beta-amyloid deposition and how this~     contributes to cognitive impairment or well-being in the elderly.~   "
46467|NCT02958657|"~     This project aims to evaluate, in recent post-acute myocardial infarction (AMI) patients on~     dual antiplatelet therapy, the impact of regular exercise training on platelet aggregability~     and the correlation between the level of platelet aggregability and muscle sympathetic nerve~     activity (MSNA).~   "
46483|NCT02958449|"~     Comparing standard wound closure technique with drains (control) to standard wound closure~     techniques with TissuGlu® and no drains (test) in mastectomy~   "
46468|NCT02958644|"~     Obese patients have a high level of intestinal microflora imbalance, with serious~     consequences such as loss of digestive function. Potential mediators of intestinal microbiota~     are prebiotics, supplements considered safe because they are naturally contained in food and~     human microbiota. Probiotics are living bacteria which are found in the normal gut~     microbiota. Synbiotics are combinations of both prebiotics and probiotics. Their use has been~     studied as a new therapeutic approach for the regulation of intestinal microbiota in various~     situations of disease, including severe obesity.~      This is a double-blind, placebo-controlled, randomized clinical trial to assess the effect of~     synbiotic supplementation (fructo-oligosaccharide and probiotic - 12 g / day) on body mass~     index in participants with obesity class III, with follow up of 90 days.~   "
46469|NCT02958631|"~     Comparison of blood pressure lowering effect between Fimasartan and Losartan in the~     hypertensive patient during night and early morning time~   "
46470|NCT02958618|"~     Limited endoscopic sphincterotomy with balloon dilation（ESBD）is a promising technique in~     treating common bile duct stones. It had the similar success rate of stone extraction, but~     its incidence of complications remained uncertain. However, there is no clinical evidence and~     guideline to define the optimal duration of balloon dilation so far. So we designed a~     prospective randomized trial to compare the effect of three different duration of balloon~     dilation during ESBD so that we can find the optimal duration of the balloon dilation.~   "
46471|NCT02958605|"~     Medication errors are common in children. Characteristics of errors during critical~     situations in the Emergency Department are ill-defined and might be more frequent than~     previously thought. However, optimal strategies to eliminate the risk of prescribing errors~     remain unknown.~      Many smartphone apps have been suggested over the last years with some of them designed to~     calculate medication dosage for children. The impact of these apps to decrease dosage error~     has never been evaluated in resuscitation setting.~      The aim of the study is to evaluate whether the use of a smartphone application designed to~     calculate medication doses decreases prescribing errors among residents during pediatric~     simulated resuscitations.~      This will be a crossover-randomized trial using high fidelity simulation among 40 residents~     rotating in the pediatric emergency department.~   "
46472|NCT02958592|"~     To evaluate the diagnostic performance of two-dimensional shear-wave elastography (SWE) for~     staging hepatic fibrosis in the background liver parenchyma in patients with liver tumors~     before hepatic resection, using resected tissue pathology as a reference standard.~   "
46473|NCT02958579|"~     Metabolic syndrome (MetS) is recognized as clustering of a number of components including~     hypertension, hypertriglyceridemia, low serum high-density lipoprotein cholesterol (HDL-C),~     impaired glucose metabolism (IGM), and abdominal obesity. It has been tightly linked to~     thrombotic vascular events including coronary heart disease (CHD). Worldwide prevalence of~     MetS is on the rise. People living in Iran, a country located in the Middle-East region, have~     distinct behavioral, environmental and social exposures which certainly affect the prevalence~     and incidence of metabolic syndrome and its comorbidities.We hypothesized that these factors~     may affect the course of metabolic syndrome and the burden that it imposes to the community.~     The purposes of MetSCoM are as follows;~        1. To find the incidence of T2D, microvascular complications of T2D (diabetic retinopathy,~          diabetic neuropathy and diabetic kidney disease), CVD, and mortality rate of subjects~          metabolic syndrome.~        2. To find the association of baseline, mean value during follow up visits and visit to~          visit variability in anthropometric variables and several metabolic laboratory variables~          with metabolic syndrome and its complications.~        3. To find the effect of behavioral variables and environmental exposures on the course of~          metabolic syndrome.~        4. To identify the best anthropometric, laboratory, life-style and environmental predictors~          of CVD and mortality rate in subjects with metabolic syndrome.~        5. To estimate the economic burden of metabolic syndrome and its related~   "
46474|NCT02958566|"~     The General Objective of this study is to investigate the cost and efficacy of treating~     patients undergoing colorectal surgical resections with an opioid limited pain control~     regimen as part of an Enhanced Recovery After Surgery (ERAS) Protocol. This group will be~     compared to a traditional opioid based pain control regimen.~   "
46475|NCT02958553|"~     A study comparing the emPOWER Ankle System to standard carbon fiber prosthetic feet, in~     active seniors.~   "
46476|NCT02958540|"~     The study is a double-blind (within dose level), placebo-controlled Phase I study to assess~     the safety, reactogenicity and tolerability of two intranasal dose levels of SynGEM®: a low~     dose level (140 μg F-protein/2mg BLPs) and a high dose level ( 350 μg F-protein/5mg BLPs),~     each administered twice according to a prime-boost schedule 28 days apart at Day 1 and Day~     29. The two dose levels will be recruited sequentially.~      Immunogenicity end-points will include assessment of humoral and cellular responses at~     selected time-points.~   "
46477|NCT02958527|"~     SECONDARY DATA COLLECTION STUDY; SAFETY AND EFFICACY OF EFFEXOR.UNDER JAPANESE MEDICAL~     PRACTICE~   "
46478|NCT02958514|"~     This study aims to evaluate the efficacy of intense pulsed light in treating dry eye caused~     by meibomian gland dysfunction and make a comparison between the traditional treatment.~   "
46479|NCT02958501|"~     The purpose of this study is to confirm anticipated substitution dose of the vitamin D for~     sustained blood level during winter time in patients with inflammatory bowel diseases (IBD)~   "
46480|NCT02958488|"~     The main objective of the study is to gather preliminary data on the effectiveness of High~     Flow Nasal canula (HFNC), provided since the delivery room, for ventilatory support in~     newborns of 34-36 weeks with moderate respiratory distress syndrome (RDS).~      The secondary objective is to evaluate the safety of HFNC in this indication.~   "
46481|NCT02958475|"~     This study is being conducted to evaluate the breastfeeding support program utilizing~     bilingual English-Spanish tailored text messages and online support to support exclusive and~     continuous breastfeeding for new mothers--comparing texting alone, texting with an online~     support group to those with usual care. The cost involved in moderating the online groups and~     providing bidirectional consultation when needed will be evaluated and qualitative feedback~     from a subset of mothers in both intervention groups will be evaluated to determine what was~     effective, as well as suggestions for improvement of the messaging program.~   "
46482|NCT02958462|"~     The use of genomics and functional translational studies is to identify and diagnose patients~     with precursor features of myeloid neoplasms and inherited bone marrow failure syndromes.~   "
46485|NCT02958423|"~     The purpose of the study is to compare the analgesic effect of 2 mA anodal direct current~     stimulation on the right primary motor cortex (M1) (tDCS) with a similar stimulation on the~     spine (D10) (tsDCS) in healthy volunteers (HV) followed by a pilot study in patients~     suffering of endometriosis-related chronic pelvic pain (CPP)~   "
46486|NCT02958410|"~     The overall purpose of this study is to explore the therapeutic effect of BCMA-targeted~     chimeric antigen receptor T(CAR-T) cells in the treatment of lymphocyte derived malignancies.~   "
46487|NCT02958397|"~     The overall purpose of this study is to explore the therapeutic effect of CD33-targeted~     chimeric antigen receptor T(CAR-T) cells in the treatment of Myeloid Malignancies.~   "
46488|NCT02958384|"~     The overall purpose of this study is to explore the therapeutic effect of LeY-targeted~     chimeric antigen receptor T(CAR-T) cells in the treatment of myeloid malignancies.~   "
46489|NCT02958371|"~     Previous studies have suggested that consumers who can choose what to eat could find food~     more pleasant, and consume more of that food, than when in absence of choice. However~     cognitive mechanisms that could explain the effect of choice have not been investigated. The~     study consists in a fMRI experiment intended to observe the effect of the presence of choice~     on brain activity following consumption of a fruit-flavored drink, compared to the brain~     activity when the same drink is consumed without choice. It is suggested that consumers will~     appreciate drinks they chose better, and that the activity in gustatory and reward regions~     will change accordingly to changes in declared food pleasure.~   "
46490|NCT02958358|"~     The investigators are doing this research study to find out how blood flow changes in the~     lungs of people with pulmonary hypertension before and after treatment with ambrisentan (sold~     under the brand name Letairis). The investigators hope that knowing about these differences~     will help us to better understand pulmonary hypertension and find new ways to diagnose it~     earlier.~   "
46491|NCT02958345|"~     Study Design:~      Double-blinded, placebo controlled study of the efficacy of Zostavax in cirrhosis.~      Subjects will receive either Zostavax or placebo and will be followed for four months.~      Hypothesis:~      The investigators hypothesize Zostavax would induce cell-based immunity in cirrhotic patients~     like that seen in elderly patients.~   "
46492|NCT02958332|"~     Aims: To demonstrate the effect of a program based on video games as a means to improve~     abilities and basic skills affected by lymphedema, and its impact on quality of life.~      Design: longitudinal, pre-experimental, with pre / post-test and evaluation, assessor blinded~     study.~      Method: Data on shoulder pain and disability, health-related quality of life, strength and~     articulate activated by the OSS (Oxford Shoulder Score), SPADI (Shoulder Pain and Disability~     Index), FACT-B + 4 (Functional Assesment of Cancer Therapy Questionnaire for Breast Cancer),~     respectively goniometry and dynamometry amplitude scales will be collected.~      The intervention will be performed with the Wii ™ console and the Wii Balance BoardTM, during~     5 individual weekly sessions of 30 minutes.~   "
46493|NCT02958319|"~     Patients with rheumatoid arthritis (RA) with positive antibodies against carbamylated~     proteins (anti-CarP) have a more severe clinical course. The primary objective of this study~     in adult subject with RA is as follows: To explore the clinical differences in activity~     indexes (Disease Activity Score of 28 joints with Erythro Sedimentaion Rate (DAS28-ESR)) at~     6, 12 and 18 months of follow up according the anti-CarP antibodies status.~   "
46494|NCT02958306|"~     The purpose of this study is to evaluate effect of platelet rich plasma on scar formation of~     unilateral cleft lip repair.~   "
46495|NCT02958293|"~     This is a retrospective cohort study using Electronic Privacy Identification Center (EPIC)~     database to evaluate if there are any differences in perioperative morbidity for elective~     surgery based on the time of the year surgery is performed.~   "
46496|NCT02958280|"~     The purpose of the study twofold: first, a smartphone-based physical activity application~     (app), which will be called Fit&Sober, will be developed and tailored specifically for~     patients with alcohol use disorders (AUDs); then, the feasibility, acceptability, and~     short-term increases in physical activity with the use of the Fit&Sober app will be examined~     over the course of a 12-week intervention.~   "
46497|NCT02958267|"~     The purpose of this study is to determine the clinical response to autologous bone marrow~     aspirate concentrate (BMAC) and platelet-rich plasma (PRP) injections for knee osteoarthritis~     with respect to pain, function, and quality of life at up to 1 year following the~     intervention. Specifically, the clinical response will be compared to baseline and a control~     group treated with a Gel-One® hyaluronate injection to the target knee.~   "
46498|NCT02958254|"~     No previous studies have compared the association between muscle thickness (MT) and muscle~     cross-sectional area (CSA) in healthy volunteers. The main aim of this study is to~     investigate the validity of ultrasound in assessing the muscle thickness of hamstrings~     muscle.~      Study design:~      A cross-sectional-validity study.~      Setting:~      University~      Participants:~      X football players of an amateur football team (X healthy volunteers and X patients with a~     previous hamstring injury).~   "
46499|NCT02958241|"~     This study investigates the possible differences in images obtained in patients with lumbar~     spondylolisthesis when positioned in an upright weight bearing position compared with~     traditional supine positioning for lumbar MRI.~   "
46500|NCT02958228|"~     The purpose of this randomized controlled trial is to establish feasibility and provide~     initial estimates of efficacy of two computerized cognitive training procedures (a form of~     Positive Mental Imagery Training, PMIT, and a form of Cognitive Control Training, CCT)~     delivered as adjuncts to treatment as usual (TAU) in inpatient mental health treatment~     settings.~   "
46501|NCT02958215|"~     Pregnant women with a positive preoperative Supine stress test were found to be a subgroup at~     increased risk of symptomatic hypotension after spinal anesthesia~   "
46502|NCT02958202|"~     The aim of this study is to provide continuing access to BMN 044 treatment for subjects~     previously treated with BMN 044. The information gained from this study is expected to~     further characterize the efficacy and safety of BMN 044 over a longer treatment period.~   "
46503|NCT02958189|"~     The purpose of this study is to determine whether a Twitter-based intervention with a~     private, online support group can significantly increase number of walking steps compared to~     self-monitoring of physical activity alone or a control group in sedentary women at a women's~     heart clinic.~   "
46504|NCT02958176|"~     Low resting heart rate variability (HRV) has been associated with sexual arousal problems and~     overall sexual dysfunction in women. Research has indicated that HRV biofeedback leads to~     increases in HRV as well as improvements in symptoms associated with several psychological~     disorders, some of which are comorbid with sexual arousal problems in women. Autogenic~     training also facilitates increases in HRV and was recently associated with acute increases~     in sexual arousal among sexually healthy women. The primary aim of the current study is to~     examine the efficacy of HRV biofeedback, with and without autogenic training, for the~     treatment of female sexual arousal disorder (FSAD).~   "
46505|NCT02958163|"~     This will be multicentre a phase II randomized controlled and open-label trial. It will~     compare the 6-months objective response (CR+PR) rates obtained with Drug Eluting Bead~     Trans-Arterial Chemo-Embolization (DEB-TACE) alone versus DEB-TACE followed by Stereotactic~     Ablative Radiotherapy (SABR) in patients with hepatocarcinoma stage BCLC B.~      This trial will also include one substudy. This substudy will confront the~     immuno-histochemical results collected on tumoral biopsies to the biological and imaging~     (MRI) results. Every patient participating to the trial can also participate to this~     substudy.~   "
46506|NCT02958150|"~     This study compare the effectiveness of dexmedetomidine as a sedative drug during NIV and the~     different strategies routinely used in patients with ARF of different aetiologies. Efficacy~     will be assessed based on absence of intubation, short term prognosis, and occurrence of~     medical complications.~   "
46507|NCT02958137|"~     Compare outcomes of ARA for isolated CMC OA versus to simultaneous ARA of CMC plus STT~   "
46508|NCT02958124|"~     The purpose of this study is to evaluate the feasibility and the security of early~     mobilization of infants in pediatric intensive care.~   "
46509|NCT02958111|"~     This is an randomized, controlled, multicenter phase 3 clinical trial. The purpose of this~     study is to evaluate the efficacy and safety of single-agent capecitabine as adjuvant~     chemotherapy in locoregionally advanced nasopharyngeal carcinoma (NPC).~   "
46510|NCT02958098|"~     The My Research Legacy Pilot Study will establish a participant registry that collects~     self-reported health data and answers to online survey questions about individual daily~     choices, diets, and exercise; data from wearable devices; and, (optional) data from genome~     sequencing analysis. Individuals under the age of 50 who meet eligibility criteria will~     answer questions using the American Heart Association's (AHA) Life's Simple 7™ My Life Check~     v4.0 three times over the course of 6 months, transmit data from a Fitbit Charge 2 device,~     and (optional) provide a saliva sample for whole genome sequencing.~   "
46511|NCT02958085|"~     This trial is conducted in The United States of America. The aim of this trial is to~     investigate Safety, Tolerability, Pharmacokinetics (the exposure of the trial drug in the~     body) and Pharmacodynamics (the effect of the investigated drug on the body) of Multiple~     Dosing of NNC0174-0833 in Subjects with Obesity or Overweight.~   "
46512|NCT02958072|"~     An International Multicenter study evaluation, off the effect of the fully autologous growth~     factor-containing patch LeucoPatch, on healing of recalcitrant malleoli ulcers.~      To compare the impact of LeucoPatch as part of usual care in multidisciplinary Foot clinic~     settings, versus usual care in the same clinics on malleoli ulcers healing.~   "
46513|NCT02958059|"~     Endoscopic retrograde cholangio-pancreatography (ERCP) is advanced endoscopic technique that~     allows minimally invasive management of biliary and pancreatic disorders. However, the~     incidence of infectious complication of ERCP is considerable. Transient blood stream~     infection after ERCP has been reported in a high ratio, up to 27% and post-ERCP infection~     accounts for about 10% of the major complications associated with mortality.~      Although prophylactic use of antibiotics is generally not recommend in all cases, debates~     about the prophylactic use of antibiotics continues and prophylactic use of antibiotics is~     recommend in case of ERCP that incomplete biliary drainage is expected.~      In this study, researchers will use prophylactic antibiotics in patients with biliary~     obstruction who have high-risk of post-ERCP bacteremia. Antibiotics regimen is selected based~     on the data of our institution, and administered to patients before ERCP procedure.~   "
46514|NCT02958046|"~     The purpose of this study is to investigate the efficacy of lansoprazole combination with~     domperidone on intragastric acidity and intraesophageal acidity, GERD symptoms, impedance~     kinetics, gastric emptying in patients with gastroesophageal reflux disease (GERD).~   "
46515|NCT02958033|"~     In this study,the eligible breast cancer patients will be randomized divided into two groups.~     the study group receive the accelerated hypo-fractioned whole breast irradiation with a~     concurrent boost to the tumor bed (WBI 2.5Gy x18 and SIB 2.88Gy x18) and the control group~     receive conventional fractioned whole breast irradiation with a concurrent boost to the tumor~     bed(WBI 1.8Gy x28 and SIB 2.15Gy x28). All radiotherapy will be delivered by external~     beam-intensity modulated radiotherapy. the purpose of this study is to assess whether the~     accelerated hypo-fractioned is non-inferior to the conventional fractionated radiotherapy.~     The outcomes evaluation will include acute toxicity , late toxicity including breast fibrosis~     and cardiac disease, cosmetic outcome ,local control and survival outcome.~   "
46516|NCT02958020|"~     This is a multicenter cohort study on osteoporosis in six cities of China which locate in the~     east, south, north, west, middle of China respectively. At least 3000 middle-aged and elderly~     permanent residents (women aged from 45 to 79, and men aged from 50 to 79) in every city were~     enrolled. Residents with severe mental diseases, physical diseases or acute infectious~     diseases who could not cooperate with the survey as well as lactating or pregnant women were~     excluded. All the enrolled residents who signed informed consent will finish questionnaire~     including demographic characteristics, history of smoking, alcohol drinking, falls and~     fracture, family, chronic diseases and medicine,diary and physical practice. Osteoporosis~     risk, health status (EQ-5D) and constitution of traditional Chinese medicine (TCM) will be~     evaluated. Fasting blood tests, bone mineral density and physical examinations (height,~     weight, waist circumference, hip circumference,grip,sit-to-stand test, tongue coating and~     pulse) will be performed at enrollment and every two years after enrollment. DNA of blood~     cells will be preserved.~   "
46543|NCT02957669|"~     The purpose of the study is to determine the impact of the offer to participate in the~     Practice Self-Regulation (PS-R) (treatment) relative to the offer to participate in the~     Therapy Practice Group (control) on increasing knowledge of sexual health and the impact of~     trauma on sexual decision-making and preventing teen pregnancy and high-risk behaviors nine~     months after the end of treatment.~   "
46517|NCT02958007|"~     Older adults with psychotic disorders experience a dual set of challenges: those related to~     serious mental illness, and those related to aging. They have medical, cognitive,~     psychological and social difficulties; as a result they have an almost four times greater~     likelihood of early institutionalization in nursing homes. These challenges make it difficult~     for this group to engage in health behaviors, such as exercise. This is unfortunate, since~     participation in health-promoting activities is essential for maintaining functional~     independence with age. This study aims to develop and pilot test a peer coaching intervention~     for older Veterans with psychotic disorders, in which VA Peer Specialists, who are Veterans~     in recovery from mental illness, will provide intensive coaching to older Veterans with~     psychotic disorders to promote their participation in exercise and physical activity. Results~     from this study will inform us as to whether this intervention is acceptable to Veterans,~     feasible to implement, and effective in increasing exercise, physical activity, and physical~     fitness/function.~   "
46518|NCT02957994|"~     To evaluate various markers of renal function and bone density after the switch to Tenofovir~     alafenamide fumarate (TAF) in chronic hepatitis B patients who are currently treated with~     Tenofovir disoproxil fumarate (TDF) .~   "
46519|NCT02957981|"~     The primary goal of this research is to develop and test a web-based genetic~     education/counseling intervention. This intervention is designed to educate men from~     hereditary cancer families about the personal relevance of genetic testing in order to help~     them make decisions about whether to pursue genetic testing. The investigators will test this~     intervention against standard care for men from hereditary cancer families. The web-based~     educational intervention includes all of the information typically covered during genetic~     counseling. As a result, after completing the education intervention participants can proceed~     directly to genetic testing if they choose. The investigators will conduct a survey prior to~     randomization and then follow-up surveys at 1-month and 6-months post-randomization. The~     primary outcome will be uptake of genetic testing. Secondary outcomes will be completion of~     genetic counseling and decision satisfaction.~   "
46520|NCT02957968|"~     This study is a 2-cohort, open-label, multicenter, phase 2 study of a short course of~     immunotherapy consisting of sequential decitabine followed by pembrolizumab administered~     prior to a standard neoadjuvant chemotherapy regimen for patients with locally advanced~     HER2-negative breast cancer. The primary efficacy objective is to determine if the~     immunotherapy increases the presence and percentage of tumor and/or stromal area of~     infiltrating lymphocytes prior to initiation of standard neoadjuvant chemotherapy. Efficacy~     will be evaluated in 2 cohorts based on hormone receptor status.~   "
46521|NCT02957955|"~     This study evaluates the addition of high-intensity interval training to the standard~     pre-heart transplantation clinical care. Participants will be randomised into 2 arms: one arm~     will receive high-intensity interval training, and the other arm will be encouraged to remain~     physically active, although they do not participate in a regular structured exercise training~     program.~   "
46522|NCT02957942|"~     Focal dystonia is a neurological movement disorder characterized by excessive involuntary~     muscle contractions of any body part. Spasmodic dysphonia (SD) is a type of focal dystonia~     characterized by excessive contraction of intrinsic muscles in the larynx, leading to~     difficulty in speaking and affecting effective communication. The cause of SD is unknown and~     there are no treatments that produce long-term benefits. Previous studies have suggested that~     SD and other focal dystonias are associated with decreased inhibition in sensorimotor areas~     in the brain. However, no studies have investigated the effects of modulating excitability of~     the laryngeal motor cortex in healthy individuals or SD. The goal of this pilot project is to~     determine if brain excitability of the laryngeal motor cortex can be changed with~     low-frequency inhibitory repetitive transcranial magnetic stimulation (rTMS) in individuals~     with SD and healthy controls. Considering that rTMS at low frequencies (≤1 Hz) produces~     lasting inhibition in the brain, and that SD is associated with decreased cortical~     inhibition, the purpose of this pilot study is to determine safety, feasibility and response~     to 1Hz rTMS to the laryngeal motor cortex in individuals with SD and healthy people. The~     results will help understand changes associated with the disorder, as well as contribute to~     the development of future clinical interventions for SD.~   "
46523|NCT02957929|"~     This is a Phase l double-blind, placebo-controlled, randomized study to investigate the~     safety, tolerability, pharmacokinetics, bioavailability and food effect of single doses of~     APX001 administered intravenously and orally, followed by an evaluation of the safety,~     tolerability, pharmacokinetics and drug-drug interaction potential of multiple doses of~     APX001 administered orally.~   "
46524|NCT02957916|"~     In order to better understand early onset obesity and to identify patients in interested in~     future research studies, including clinical trials, we aim to develop a registry for patients~     with early onset obesity.~   "
46525|NCT02957903|"~     The purpose of this study is to investigate and describe the anatomical distribution of the~     sensory outcome following LFCN block (LFCN = lateral femoral cutaneous nerve) in relation to~     the incisional lines after Total Hip Arthroplasty (THA). Furthermore, is the aim to examine~     whether there is a motorial outcome corresponding to the Femoral nerve. The trial will be~     conducted in healthy volunteers in a blinded, randomized paired study.~   "
46526|NCT02957890|"~     This study evaluates the immunogenicity of adding inactivated influenza vaccine with southern~     hemisphere (SH) formulation to standard once-annual influenza vaccination with northern~     hemisphere (NH) formulation in older adults in Hong Kong over 5 years. Half of participants~     will receive twice-annual influenza vaccination with NH and SH formulation, while the other~     half will receive once-annual influenza vaccination with NH formulation and a placebo.~   "
46527|NCT02957877|"~     There is a lack of data in the literature about the use of low-molecular weight heparin~     (LMWH) as anticoagulation for nocturnal home hemodialysis (NHHD). This study aims to evaluate~     the efficacy and safety of LMWH, administered by infusion method, as compared to~     unfractionated heparin as anticoagulation for NHHD treatment.~   "
46544|NCT02957656|"~     The purpose of this study is to evaluate the safety and immunogenicity of one dose of H7N9~     pandemic live attenuated influenza vaccine (H7N9 pLAIV) followed by AS03-adjuvanted H7N9~     pandemic inactivated influenza vaccine (H7N9 pIIV).~   "
46545|NCT02957643|"~     The purpose of the study is to investigate the effectiveness of iron in the treatment of iron~     deficiency in pregnant 2nd and 3rd quarter. Every 30 days the investigators measure the~     hemoglobin, hematocrit and iron in serum and assess the course of treatment.~   "
46528|NCT02957864|"~     Tenofovir disoproxil fumarate (TDF) is one of the most frequently used drugs to treat HIV.~     Long term use of TDF can induce renal toxicity. Tenofovir alafenamide (TAF) is a new pro-drug~     of Tenofovir which has not been associated with renal toxicity and may therefore be a good~     substitute for TDF in patients with TDF induced renal toxicity. Abacavir (ABC) is another~     drug that can be used for the treatment of HIV and is not associated with renal toxicity.~      In this study the investigators will compare the effect on renal function of a switch from~     TDF to TAF with a switch from TDF to ABC in patients with TDF induced renal insufficiency.~   "
46529|NCT02957851|"~     To assess the effect of 3 consecutive days of one-hour administration of Nitrous Oxide/Oxygen~     50%/50% (EMONO) versus placebo as Oxygen/Nitrogen 22%/78% (synthetic medical air), in add-on~     therapy to chronic analgesic treatments, on average pain intensity in patients with chronic~     peripheral neuropathic pain. A total of 250 randomised patients to be included in all the~     participating centres, i.e., 125 randomised patients in each of the 2 study groups treatments~   "
46530|NCT02957838|"~     The purpose of this crossover study is to determine whether nutritional supplementation of~     C18:0 in humans has mitochondrial effects as shown in Drosophila and human cell culture. We~     will compare a study cohort of patients with diagnosed type 2 diabetes with non-diabetics.~     Participants will undergo a 2-day low-fat vegan diet and will then be supplemented with a~     bolus of C18:0. Changes in the mitochondrial morphology and function of white blood cells~     will be scored by immunofluorescence and FACS analysis.~   "
46531|NCT02957825|"~     The aim of this study is to test the hypothesis that continuous wireless monitoring on the~     postsurgical ward will improve patient outcome, measured as disability-free survival at three~     months after surgery. Further, the investigators hypothesize that this tight control regimen~     decreases length of hospital stay and treatment costs in patients with complications.~   "
46532|NCT02957812|"~     The purpose of this study is to explore the long-term effects that orthotics imposes on the~     structure and function of the foot. The objectives of the study are to determine if the use~     of custom-made foot orthotics (CFO) cause: (a) changes to the structure of the plantar~     intrinsic muscles, (b) changes in the rate of muscle activity and timing in the plantar~     intrinsic muscles and (c) creates any changes in balance control during gait termination. The~     aim of the study is to enhance the appropriate dispensing of orthotics, and whether~     additional measures, such as rehabilitation exercises are necessary to increase their overall~     effectiveness in the clinical setting.~   "
46533|NCT02957799|"~     The purpose of this study is to address the United States Office of AIDS Research highest~     priorities: improving the workforce, reducing health disparities, and addressing HIV~     comorbidities. UCLA will randomize the government-funded community health workers (CHW) from~     16 clinics in matched rural areas in the Eastern Cape in South Africa to either: 1) the~     Accountable Condition (AC) in which additional monitoring and accountability systems that~     Philani routinely uses are implemented or 2) a Control Condition (CC), of initial Philani~     training, but ongoing supervision and monitoring consistent with local government practices.~   "
46534|NCT02957786|"~     To evaluate the effectiveness, safety, and cost-effectiveness of cytisine plus behavioural~     support compared to varenicline plus behavioural support for smoking cessation, in indigenous~     Māori (or family of Māori) who smoke and are motivated to quit.~   "
46535|NCT02957773|"~     This project will be a randomised controlled trial to investigate the effectiveness of an~     integrated programme by using social art activity (SA) and exercise, for instance, Qigong~     (QG, a traditional Chinese exercise) as a therapeutic medium.~      This integrated programme aims to increase the well-being and reduce the depressive symptoms~     that are frequently ascertained in older people who live in nursing homes. The combination of~     SA and QG might be more beneficial to older people than either individual activity on its~     own, given that they are addressing different areas of functioning. The art activity focuses~     on self-expression in non-verbal activity using fine motor movement, whereas physical~     exercise like Qigong focuses on awareness of breathing and a calm state of mind. This is to~     help the older person achieve mental and physical relaxation by using gross motor movement.~     When the interventions are combined by utilising Qigong ahead of the art activities (thus,~     including both fine and gross motor movements) older people will reach a state of mental and~     physical relaxation, and moreover, will be able to express their feelings more simply in the~     social art activities.~   "
46536|NCT02957760|"~     The central retinal vein occlusion (CRVO) is a major cause of ocular morbidity, depending in~     particular on the occurrence and extent of retinal ischemia by capillary occlusion. There is~     no effective systemic treatment of this condition. An increase in the adhesion of~     erythrocytes to vascular endothelium was observed for patients with CRVO, correlated with~     overexpression of membrane phosphatidylserine~   "
46537|NCT02957747|"~     Lifetime sexual trauma (ST) (i.e., behaviors that range from unwanted sexual touching to~     attempted or completed rape) is a significant social and public health problem among women~     Veterans. For women Veterans, lifetime ST can occur prior to, during or after military~     service. ST is associated with multiple difficulties and risks, including posttraumatic~     stress disorder (PTSD), intimate partner violence (IPV), and alcohol misuse. Providing an~     effective, integrated, and low-cost intervention that targets ST-related risks for women~     Veterans with lifetime ST would advance clinical care for these vulnerable women.~      This research will develop and assess a computer-delivered intervention (Safety and Health~     Experiences Program; SHE) that will provide a screening and brief behavior intervention for~     women Veterans with any lifetime ST. More specifically, the intervention, SHE, will address~     interrelated health concerns for women Veterans with ST (i.e. alcohol misuse, IPV, and PTSD).~     SHE will be designed to provide individualized assessment, feedback, and referrals for women~     Veterans with any lifetime ST. SHE will take place within a primary care setting. Primary~     care visits are frequent points of health care contact for women Veterans making the visit~     itself the ideal, and possibly only, opportunity to provide behavioral interventions.~      This study will lay the groundwork for a larger clinical trial of the SHE program in multiple~     VA primary care settings. If effective, the intervention, SHE, represents an innovative and~     low cost service for early identification and intervention that could be implemented~     nationwide with ease and speed to address the needs of women Veterans with lifetime ST. The~     long-term goal of the project is to make a significant impact on advancing health services~     research by introducing and testing a novel and potentially powerful service tool that may~     improve service delivery to address the co-occurring health concerns for women Veterans with~     any lifetime ST.~   "
46538|NCT02957734|"~     LAVA Ultimate composite restorations will be used as restorative material to reconstruct~     severely worn dentitions.~   "
46539|NCT02957721|"~     The following are hypothesized:~        1. The Diabetes Engagement and Activation Platform (DEAP) can be integrated into primary~          care workflow to facilitate the care of patients with type 2 diabetes.~        2. The DEAP intervention will be feasible and acceptable to patients with type 2 diabetes.~        3. The DEAP intervention will enhance patient activation and improve type 2 diabetes self~          management and glucose control~   "
46547|NCT02957617|"~     The primary objective of the study is to evaluate the long-term safety and tolerability of~     BIIB074 in participants with neuropathic Pain From Lumbosacral Radiculopathy (PLSR). A~     secondary objective is to investigate the maintenance of effect during long-term treatment~     with BIIB074 in participants with neuropathic PLSR. For all efficacy assessments, baseline~     will be prior to randomization into Study 1014802-203. Another secondary objective is to~     evaluate the impact of treatment with BIIB074 on quality of life (QoL).~   "
46548|NCT02957604|"~     This is a prospective observational registry study to evaluate fetal, infant and childhood~     outcomes in women exposed to evolocumab during pregnancy~   "
46549|NCT02957591|"~     Recent research demonstrates that the composition of the gut microbiome is a master regulator~     of key neurophysiological processes that are affected in depression. Indeed, contemporary~     studies showed that faecal microbiota is altered in patients with major depressive disorder~     (MDD). Furthermore, it has also been shown that supplementation of probiotics ameliorated~     depressive symptoms in unmedicated patients with mild to moderate depression. However, no~     study has yet explored the efficacy of a probiotic-based therapy in patients with severe MDD~     in addition to a standard antidepressant treatment. As dietary and lifestyle interventions~     may be a desirable, effective, pragmatical and non-stigmatizing prevention and adjuvant~     therapy (in addition to antidepressant treatment) in depression, this project is aimed at~     investigating for the first time if probiotic supplementation compared to a placebo treatment~     improves the effect of standard antidepressant medication on depressive symptoms (i.e. better~     and faster remission) in patients with severe MDD. Furthermore, this study will further test~     if probiotic supplementation modulates immune signalling and inflammatory processes~     (macrophage migration inhibitory factor and interleukin 1 beta),~     hypothalamic-pituitaryadrenal (HPA) axis responses (saliva cortisol), neurogenesis~     (brain-derived neurotrophic factor (BDNF) expression), the release of appetite-regulating~     hormones (leptin and ghrelin), the composition of gut microbiota (in particular levels of~     Enterobacteriaceae, Alistipes and Faecalibacterium) and brain perfusion, structure and~     activation and if these changes are associated with the probiotic-induced effect on~     depressive symptoms.~   "
46550|NCT02957578|"~     This is a multi-centre, single arm study to evaluate the placement of tympanostomy tubes with~     the AventaMed Solo Tympanostomy Tube Device (TTD)~   "
46551|NCT02957565|"~     The goal of this research study is to learn how patients feel about their doctors' attitudes~     toward supportive care and treatment options for advanced cancer patients.~   "
46552|NCT02957552|"~     Since the introduction of calcineurin-based immunosuppression, patient and graft survival in~     pediatric liver transplantation (LT) improved significantly. However, in contrast,~     calcineurin inhibitor (CNI) toxicity leads to significant morbidity and impairs quality of~     life for recipients. Moreover, CNI cannot prevent long-term allograft inflammation and~     fibrosis.~      Mesenchymal stem (stromal) cells (MSC) have potent immunomodulatory properties potentially~     promoting allograft tolerance and ameliorating toxicity of exposure to high dose CNI.~     Previous trials for non-solid organ transplant indications have shown an excellent safety~     profile of intravenous MSC application. The MYSTEP1 trial aims to investigate safety and~     benefits portal and intravenous MSC infusion in pediatric LT.~   "
46553|NCT02957539|"~     Three of every four Veterans are overweight or obese, and weight loss is associated with~     reduced morbidity and mortality. The VA MOVE! program for weight loss is moderately effective~     but only reaches a small percentage of overweight Veterans. This proposed study will test~     whether a patient incentive program that gives Veterans non-financial incentives, such as~     Seattle Mariners baseball tickets, for losing one pound per week over 16 weeks is effective.~     An effective patient-incentive program could help more Veterans lose weight without requiring~     a substantial increase in VA staff.~   "
46554|NCT02957526|"~     The purpose of this study will be to test the use of a web-based mobile application (app)~     initiated at the time of hospital discharge to provide real-time monitoring and better~     management of treatment-related adverse symptoms among patients with hormone-receptor~     positive breast cancer and a new aromatase inhibitor prescription.~   "
46555|NCT02957513|"~     The overall goal of this study is to compare how well motivational messages (text messages~     from the doctor's office), diabetes health coaches, and enhanced usual care with diabetes~     education materials (provided at the doctor's office) work to help African-American adults~     with uncontrolled diabetes improve their diabetes self-care decisions. Self-care is difficult~     when you have diabetes, especially when patients have other medical conditions, their~     diabetes is uncontrolled, and when they live in an area without many primary care doctors.~     Many studies have show that encouraging text messages from the doctor's office and health~     coaches can help people take better care of themselves. But before primary care clinics~     around the country start trying to send texts, hire health coaches, or provide additional~     educational materials it is critical for them to know which approach is more likely to help.~      This study will assign African-American diabetics to either text messages, health coaches, or~     enhanced care to find out which one works better. The investigators especially want to find~     out if one works better for people at highest risk. Lastly, the investigators want to find~     out if messages or coaches help people improve their blood sugar, quality of life, and their~     feelings about primary care.~      The study will test messages, coaches, and enhanced care side by side in primary care~     doctors' offices. The messaging and coaching programs will give patients pretty much the same~     information, but in different ways. The text messages will be written carefully based on each~     patient's needs and interests. The coaches will be trained in how to help people get~     motivated and work to reach their health goals.~      This study will include 1000 African-American adults, ages 35-75, with uncontrolled diabetes~     and one or more additional chronic condition, living in medically underserved communities.~     People will have to have a cell phone or smart phone with texting capability and be able to~     use it to participate. 400 participants will get messages, 400 will get coaches, and 200 will~     receive enhanced care.~      The investigators will be able to tell if messages and coaches work by seeing if people~     improve their diabetes self-care decisions, and if their blood sugar, quality of life, and~     feelings about primary care get better. The long-term study goal is to get primary care~     clinics all over the country to start using motivational messages or health coaches if they~     work well.~   "
46556|NCT02957500|"~     The purpose of this study is to evaluate the efficacy and safety of Mediclore®, as an~     antiadhesive barrier, which is made of Poloxamer, Gelatin and Chitosan.~   "
46557|NCT02957487|"~     The aims of this clinical study conducted at a dental specialty clinic in Drammen, Norway are~     to assess the clinical outcomes of patients with an edentate upper jaw having been treated~     with a removable full prosthesis supported by 3 implants to restore function and aesthetics.~     Clinical variables beyond implant dimensions and intraoral location, such as recall routines,~     maintenance needs, patient satisfaction and quality of life, will also be appraised and~     contrasted with an aim to elucidate their association with clinical outcomes. Specific~     evaluation will be done with regard to the following outcome criteria:~        -  crestal bone levels and periodontal conditions around implants~        -  incidence rates of biological, technical, traumatic failures / complications related to~          implants~        -  incidence rates of biological, technical, mechanical, esthetic failures/complications~          with prosthesis and prosthetic components A secondary objective is to identify the~          different risk factors for biological failures / complications, including the influence~          of medical conditions and tobacco use.~   "
46558|NCT02957474|"~     This is an open label, single-center, 4-period, 6-sequence study in healthy subjects to~     compare the PK of GED 0301 after a single oral dose in the fed and fasted state, and after co~     administration with omeprazole, a proton pump inhibitor.~      The study will consist of a screening phase, a baseline phase, four treatment periods, and a~     follow up phone call five days (± 1 day) after discharge.~   "
46559|NCT02957461|"~     This study is designed to validate the performance of the algorithms to be used in future~     commercial device.~   "
46560|NCT02957448|"~     This study is to evaluate the effect of multiple doses of rifampin on the single-dose PK of~     BMS 986141 with parameters like Cmax, AUC(INF), AUC(0-T), AUC(0-144h)~   "
46561|NCT02957435|"~     The purpose of this study is to evaluate the pharmacokinetics profile of the formulation of~     eplerenone coated tablets in the concentration of 25mg, 50mg and 100mg (2 coated tablets of~     50mg) in male and female healthy subjects under fasting condition.~   "
46562|NCT02957422|"~     The purpose of this study is to learn if increased dairy food consumption helps brain health~     in older adults by protecting nerve cells from damage.~   "
46563|NCT02957409|"~     The purpose of the study is to describe the heart failure with reduced ejection fraction~     (HFrEF) patient population receiving sacubitril/valsartan treatment.~   "
46564|NCT02957396|"~     Finerenone is developed for the treatment of diabetic kidney disease (adults) and chronic~     kidney disease (children). The purpose of the proposed trial is to test the pharmacokinetics~     of a novel liquid formulation for the treatment of children in comparison to the adult tablet~     formulation.~   "
46565|NCT02957383|"~     Light exposure is on the rise in recent years. In large part because of unintentional~     illumination from screens that emit light directly into the eyes. Millions of computers,~     tablets, televisions, and smart-phones are sold worldwide every month and the usage time of~     these devices is increasing constantly. Today, people are exposed to ongoing light exposure~     from these device screens, emitting short wave length (SWL) during day and night hours,~     whether as active or passive users. In sum, artificial light at night (ALAN) seem to affect~     human circadian rhythmicity (melatonin and thermoregulation) and sleep, with two major~     factors. First, wavelength of light, with SWL being most detrimental to sleep and rhythms,~     when compared to LWL (Brianard et al., 2001). Second, a dose-response relationship exists~     between increasing light intensity and poorer sleep/circadian rhythms (Brianard et al., 1988;~     West et al., 2011).~      Based on existing knowledge, we hypothesize that when compared to long wavelength LWL~     illumination, short wavelength SWL illumination from computer screen will have a more~     damaging effect on melatonin (MLT) production and secretion, interfering body temperature~     regulation and affecting sleep quality, efficiency and sleep architecture. In addition, we~     hypothesized that intensity of the screen illumination will play another important factor on~     these outcomes, we assume that high intensity compared to low intensity will have more~     damaging effect on: melatonin, thermoregulation and sleep.~   "
46566|NCT02957370|"~     This project focuses on developing specific and sensitive detectors of biomarker-based~     signatures associated with diagnosed and recurrent bladder cancer.~   "
46567|NCT02957357|"~     Through this study, the investigators seek to identify the benefits (improved survival) and~     harms (more procedures, more treatment, side effects, and quality-of-life impact) from~     different surveillance frequencies—every three vs. six vs. 12 months. Using the National~     Cancer Database and quality-of-life data from a large group of prostate cancer survivors, the~     investigators aim to compare survival, procedures/tests, treatments, and side effects in~     prostate cancer survivors who are followed with alternative surveillance frequencies and~     compare quality-of-life outcomes. The overall goal of the study is to provide high-quality~     data that will allow development of a personalized, risk-based tailored approach to~     post-treatment surveillance for prostate cancer.~   "
46568|NCT02957344|"~     Through an online survey, participants will be shown different visual presentations of~     vaccination data related to schools and child care centers. Participants will rate how~     important this information is when thinking about their child's health and school choice.~     Participants will also be asked survey questions about their knowledge of Colorado state~     vaccination legislation, their opinions and practices related to childhood vaccinations, and~     their views of a Zika virus vaccine.~   "
46569|NCT02957331|"~     The purpose of this study is test the effect of beta-adrenergic blockade on mortality in~     patients with traumatic brain injury with the hypothesis being that the addition of beta~     blockade to the treatment regime of this patient population will lower mortality and supress~     the catecholamine surge that accompanies traumatic brain injury as compared to those who do~     not receive beta blockade.~      Half the patients will be randomized to receive propranolol and half will be randomized to~     receive no beta blocker.~   "
46570|NCT02957318|"~     Results have indicated that some dietary fibers increase fecal fat excretion and particularly~     viscous fibers suppress appetite sensation and reduce energy intake. Both these effects may~     contribute to body weight management.~      Aim: The aim of the study is to investigate the potential of 3-weeks daily intake of potato~     pulp (FiberBind), rhamnogalacturonan I isolated potato fiber (RG-I) vs. a low-fiber control~     (placebo) on satiety and fecal fat excretion in healthy adults. Furthermore, a number of~     secondary endpoints are investigated.~   "
46571|NCT02957305|"~     Local current protocol for cervical ripening in 1st trimester miscarriage recommends 400 µg~     of misoprostol intravaginally 3 hours before uterine evacuation. This regime has been~     recommended by some international guidelines . So far, there are no recent studies comparing~     cervical dilatation between 400 µg of misoprostol and a reduced dose (e.g., 200 µg). If~     cervical ripening is similar between these two regimens, costs reductions and lower side~     effects may be issued without losing quality of cervix dilatation.~   "
46604|NCT02956850|"~     This sponsor-open, investigator- and participant-blinded, multi-center study will assess the~     safety, tolerability, pharmacokinetics and pharmacodynamics of RO7020531 in healthy~     participants and in participants with chronic hepatitis B. Part I will be conducted in two~     portions: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) which will include~     only healthy volunteers. Part II will commence after completion of the MAD portion of Part I~     and will include only Chronic Hepatitis B (CHB) participants.~   "
46572|NCT02957292|"~     The intrauterine device (IUD) is a long-term birth control method that has demonstrated high~     contraceptive efficacy and effectiveness due to its high compliance, adherence and~     persistence of use. The IUD has a global prevalence rate around 14% in women of reproductive~     age.~      Side effects are the main reason for IUD use discontinuation. The most common reasons for~     copper IUD discontinuation are increased menstrual bleeding, irregular bleeding and~     dysmenorrhea, whereas in the case of 52mg Levonorgestrel IUD are irregular bleeding and~     amenorrhea.~      In 2014, a new hormonal IUD containing13,5mg of Levonorgestrel was marketed in Spain. There~     are many studies comparing the two Levonorgestrel IUDs. However, there is any study comparing~     the IUD 13,5mg Levonorgestrel with classic copper IUDs.~      The hypothesis of this trial is that Levonorgestrel (13,5mg) IUD users have a menstrual~     bleeding pattern with fewer days than Copper 380 mm2 IUD users.~      This is a Phase IV, national single-center, randomized 1: 1, single-blind, comparative,~     parallel controled trial.~   "
46573|NCT02957279|"~     The amount of peripheral blood exosomes has been confirmed to change in the endotoxin-induced~     infection. The primary objectives of this study are to compare the changes of peripheral~     blood dendritic cell-derived exosomes in the patients with sepsis and the healthy controls.~   "
46574|NCT02957266|"~     The purpose of this study is to define an effectiveness of concurrent chemoradiotherapy of~     cervical cancer patients treated by VMAT (volumetric arc therapy) based external beam~     radiotherapy, polyradiosensitization by cisplatin and gemcitabine and interstitial~     brachytherapy.~   "
46575|NCT02957253|"~     This study compare the effects of traditional follow-up by physician with a combined~     follow-up alternately by physician and nurse-led clinic. The main variable is; health related~     quality of Life. Participants are randomized into control group or intervention group.~   "
46576|NCT02957240|"~     Nearly 2 out of 10 women will sustain a distal forearm fracture throughout their~     lifespan.Recent longitudinal studies illustrate that as many as 1/3 of all persons who~     undergo closed reduction and casting for distal radius fractures (DRF) go on to develop type~     1 complex regional pain syndrome (CRPS). Graded motor imagery (i.e., motor imagery and mirror~     therapy), a movement representation technique, is strongly supported in the literature as a~     treatment of CRPS and has recently been suggested as a potential strategy to prevent its~     onset. Other complications include disability, wrist/forearm tightness and sensorimotor~     changes.~      The investigators propose that an early intervention protocol which includes graded motor~     imagery (GMI) will improve the pain, functional and upper limb sensorimotor outcomes of~     persons following closed reduction and casting of DRF relative to a standard of care~     intervention.~   "
46577|NCT02957227|"~     This study evaluates the use of an EEG device using Event Related Potentials to help diagnose~     Alzheimer's Disease in the outpatient clinical setting.~   "
46578|NCT02957214|"~     The purpose of this study is to obtain imaging biomarkers based on changes in activity~     patterns and changes in brain connectivity obtained with the analysis of functional magnetic~     resonance imaging (fMRI) and tractography that are related to chronic pelvic pain~   "
46579|NCT02957201|"~     All patients awaiting to have either a left atrial appendage closure (LAA) or patent foramen~     ovale (PFO) or Atrial Septal Defect (ASD) closure device as part of standard care will be~     identified and reviewed in cardiology clinics. These patients will be placed on waiting list~     to undergo the procedure. Patient-participants will be consented on the date of admission for~     device closure implantation.~      The study will recruit 20 patients divided into; 10 patients undergoing PFO/ASD closure and~     10 patients undergoing LAA closure. EPC will be measured on the day of the device~     implantation, day 0 and prior to discharge on day 1.~      Patient participants are admitted overnight after the device closure implantation. Then on~     subsequent out patient cardiology research clinic follow appointments on days (3-4) and~     (7-8).~   "
46580|NCT02957188|"~     The purpose of this study is to determine the kinetics of 13C-eicosapentaenoic acid (EPA) and~     13C-arachidonic acid (AA) in young and older participants~   "
46581|NCT02957175|"~     The purpose of this study is to develop an immune-phenotype based prediction of postoperative~     SIRS in patients undergoing open heart surgery.~   "
46582|NCT02957162|"~     Cardiovascular disease is a major cause of morbidity and mortality worldwide. There are a~     number of risk factors for coronary artery disease and all to often patients admitted with an~     acute coronary syndrome have these comorbidities.~      The main stay of treatment of such patients is to perform coronary angiography and if~     required coronary angioplasty.~      Previous studies have shown a link between endothelial progenitor cell (EPC) count, coronary~     artery disease and statin therapy or loading, however these studies have excluded patients~     with significant comorbidities and therefore have not truly represented real life patients.~     This pilot study will assess EPC response in patients that are able to undergo coronary~     intervention as part of their normal clinical management under current guidelines regardless~     of pre-existing comorbidities. The research team believe this will allow representation of~     real world patients.~   "
46583|NCT02957149|"~     Can platelet rich plasma applied to nerve bundles at time of surgery help the nerve bundles~     heal? Subjects undergoing a Radical Prostatectomy who meet study inclusion/exclusion criteria~     will be consented to receive an intraoperative application of platelet-rich plasma, made from~     their own blood at the time of surgery, for application onto their neurovascular bundles in~     an effort to improve the healing process. Subjects will be followed for an additional 18~     months to determine the efficacy and safety of this procedure.~   "
46605|NCT02956837|"~     The purpose of this study is to rank different RSV vaccine dosages of antigen (or~     formulations) based on safety/reactogenicity and immune response data. The formulations~     eliciting strong immune responses while maintaining an acceptable safety profile will be~     considered for further evaluation, including in studies vaccinating pregnant women.~   "
46631|NCT02956499|"~     First In Human (FIH), randomized, double-blind, placebo-controlled single ascending dose~     (SAD) and multiple ascending dose (MAD) escalation study of approximately 80 subjects. The~     SAD portion of the study will enroll six cohorts of eight healthy subjects per cohort, for a~     total of approximately 48 healthy subjects. The MAD portion of the study will enroll four~     cohorts of eight healthy subjects per cohort, for a total of approximately 32 healthy~     subjects.~   "
46584|NCT02957136|"~     This is a randomized clinical trial to assess the effect of rapid, near point-of-care testing~     for multiple common respiratory viruses and bacteria on antibiotic and anti-influenza~     medication use in emergency department (ED) patients with symptoms of influenza-like illness~     (ILI) and/or upper respiratory infection (URI). The intervention is a rapid,~     multi-respiratory pathogen nucleic acid amplification panel test (FilmArray Respiratory~     Panel; BioFire Diagnostics, LLC) with clinical result reporting within two hours of sample~     collection. Randomization is at the individual patient level. Intervention patients will~     receive usual care plus the rapid multi-respiratory pathogen test. Control patients will~     receive physician-directed usual care without the rapid, multi-respiratory pathogen test,~     which may include but is not limited to no testing, point-of-care influenza testing, or~     delayed testing for multiple respiratory pathogens at an off-site laboratory. The primary~     outcome is antibiotic administration or prescription during the initial ED episode of care.~     The investigators primary hypothesis is that rapid multi-respiratory pathogen testing will be~     associated with a ≥15% reduction in antibiotic use in intervention patients, relative to~     control patients (usual care). The investigators secondary outcome is administration or~     prescription of antivirals during the initial ED episode of care. The investigators secondary~     hypothesis is that rapid multi-respiratory pathogen testing will improve anti-influenza~     medication use in intervention patients (composite rate of anti-influenza treatment in~     positive patients and non-use of anti-influenza treatment in negative patients), relative to~     control patients receiving usual care alone.~   "
46585|NCT02957123|"~     The investigators have designed an innovative proof-of-concept trial designed to provide data~     as to whether the treatment/rehabilitation efficacy and functional outcome of patients with~     organic brain syndrome are improved with intranasal inhalations of bioactive factors (BF),~     produced by autologous M2 macrophages (auto-M2-BFs). The rationale for this approach is the~     ability of central nervous system to repair and the important role of macrophages in the~     regulation of this process. It was found that type 2 macrophages have anti-inflammatory and~     reparative potential, whereas M1 cells possess pro-inflammatory and neurotoxic effects.~     Action of M2 macrophages is largely realized through the production a wide variety of~     bioactive factors (cytokines, chemokines, growth factors, neuropeptides, microvesicles etc)~     that inhibit inflammation, protect neurons from apoptosis, stimulate neurogenesis, the growth~     and remyelination of axons, the formation of new synapses and activate angiogenesis. This~     study uses auto-M2-BFs, as therapeutic agents and intranasal administration focusing on nose~     to brain transport, as a mode of delivery. Expected clinical effects in treated subjects:~     improvement of cognitive functions (memory, language, attention); correction of focal~     neurological deficit (paresis, spasticity, sensory disorders); reduction vestibular/ataxic~     disorders (vertigo, unsteadiness when walking); reduction of headaches; reduction of asthenia~     (weakness, fatigue); correction of emotional disorders (anxiety, depression).~   "
46586|NCT02957110|"~     The purpose of this study is to investigate whether daily laughter frequency is associated~     with pain intensity and emotional state ratings in individuals who have fibromyalgia~     syndrome.~   "
46587|NCT02957097|"~     The purpose of this study is to assess the effectiveness of pre-operative administration of~     gabapentin 900 mg in management of acute post-operative pain in patients undergoing oral and~     maxillofacial surgical procedures.~   "
46588|NCT02957084|"~     In this prospective, open cohort study the diagnostic value of tests based on neck anatomy in~     predicting difficult laryngoscopy was assessed.~      The anatomic features of the neck measured were head extension, mouth opening, upper lip~     bite, Mallampati class, thyromental distance, sternomental distance, ratio of height to~     thyromental, neck circumference, thyrosternal distance, hyomental distance at full head~     extension (FHE) and at neutral position (NP), ratio of neck circumference to thyromental~     distance and ratio of hyomental distance FHE to hyomental distance NP.~   "
46589|NCT02957058|"~     To prospectively validate the SERT (Sydney EMR Recurrence Tool) scoring system for adenoma~     recurrence rates around the endoscopic mucosal resection (EMR) scar after wide field-EMR with~     thermal treatment applied to the defect margin. The primary aim of the study will be to~     ensure the safety of this approach and there will be constant monitoring to ensure that this~     is the case.~   "
46590|NCT02957045|"~     Pressure generated by cough is an expression of expiratory muscle strength. Cough pressure~     (Pcough) is usually measured with gastric and/or esophageal catheters, but these are often~     either inconvenient or uncomfortable for the patient. The aim of this study was to evaluate~     whether central venous, vesical or rectal catheters could be useful to measure cough~     pressures as alternative sites to standard esophageal and gastric balloons.~   "
46591|NCT02957032|"~     Phase I, open label, non-randomized, multicenter, prospective dose escalation study of F16IL2~     in combination with very low-dose cytarabine in subjects with acute myeloid leukemia relapse~     after allogeneic hematopoietic stem cell transplantation (alloHSCT).~   "
46592|NCT02957019|"~     Phase I/II, open-label, multicenter, prospective study.~   "
46593|NCT02957006|"~     Currently loop recorders diagnose arrhythmias and send automatic alerts to physicians based~     on R to R relationships only. We believe arrhythmia diagnostics could be improved if accurate~     detection of P and T waves as well as QRS complexes were possible.~      There is no technique available for long term outpatient monitoring of QT intervals for~     patient at risk of torsade de pointes when receiving QT prolonging drugs. We believe that if~     an accurate T wave detection algorithm were developed loop recorders could be used to monitor~     the QT interval, and perhaps even provide alerts for patients at risk.~      The objective of this study is to see if an algorithm can be developed to accurately define P~     and T waves using data from an implantable loop recorder.~   "
46594|NCT02956993|"~     The research study is designed to assess the technical feasibility and safety of a~     perivascular injection of vonapanitase delivered via micro-infusion catheter to the distal~     popliteal, tibial or peroneal arteries immediately following successful angioplasty.~   "
46595|NCT02956980|"~     Differences in pDCs function related to gender have been demonstrated in adults but have~     never been addressed in children. Yet, differences in immune responses related to gender also~     exist in children, both in responses to pathogens and susceptibility to autoimmune diseases.~     The investigators suppose that these differences are partly linked to difference in pDCs~     functions. This study aim is to compare pDCs functions in children based on gender and~     pubertal status. This study will be performed in healthy children, boys with Klinefelter~     syndrome and girls with Turner syndrome.~   "
46597|NCT02956954|"~     Anderson Fabry disease (AFD) is an X-linked lysosomal storage disorder caused by a deficiency~     of the enzyme alpha-galactosidase. AFD can involve various organs and lead to a series of~     clinical abnormalities. Left ventricular hypertrophy in middle-aged men is one of its life~     threatening complications. It was shown that pending the absence of myocardial replacement~     fibrosis, substitution therapy could improve myocardial morphology and function as well as~     exercise capacity. Today, there is no available marker of the efficacy of the treatment on~     the heart morphology and function.~      The T1 time (or longitudinal relaxation time) is one of the major components of the image~     formation in Magnetic Resonance Imaging (along with T2 time and proton density). Several~     techniques have been described to assess the myocardial T1-time.~      One of them called MOLLI (Modified Look Locker Inversion Recovery), was made available in~     research centres by the Siemens company. In a study published in 2013, Sado et al. showed in~     a series of various conditions (hypertension, AFD, hypertrophic cardiomyopathy, AL~     amyloidosis, aortic stenosis and healthy volunteers) that a septal T1 below a threshold of~     940ms could discriminate AFD patients. No overlap was shown with other conditions in this~     study. Our experience with T1 mapping supports that finding (even though our threshold could~     be slightly different), and we could recently detect by MRI a number of AFD patients, some of~     them with hypertrophy, some others without hypertrophy. The effect of Replagal® on the T1~     relaxation time remains unknown.~      The purpose of that study was to follow-up the heart morphology, function and myocardial T1~     relaxation time in a population of treated/untreated patients.~   "
46598|NCT02956941|"~     A cluster randomized controlled trial was chosen to exploit the robustness of this design to~     help ascertain the efficacy of the BCC intervention compared to the routine dietary practice.~     This protocol was developed according to the guidelines of the Consolidated Standards of~     Reporting Trials (CONSORT) statement extension for cluster randomized trials.~      The present study is aims to evaluate the effect of improving micronutrient intake through~     behavior change communication intervention on nutritional status and academic performance of~     school age children. Moreover, it may help to prevent or mitigate malnutrition. However to~     the best knowledge of the authors, BCC intervention using posters, and lecture for school~     teachers and students have not yet been empirically tested generally in Ethiopia,~     specifically in the study area context. The present intervention is unique in combining the~     use of conventional BCC intervention tools, that is, lecture and posters as reminder for~     intervention reinforcement.~   "
46599|NCT02956915|"~     Transcatheter aortic valve implantation (TAVI) has been rapidly adopted worldwide since the~     first-in-man TAVI performed in 2002. With increasing experience and improvements in valve~     design, the minimalist approach to transfemoral TAVI (using local anesthesia and~     fluoroscopic guidance) has become an attractive concept, and the technical feasibility of~     this approach has been well documented.~      While earlier data showed prolonged length of stay after TF-TAVI [10.5 ± 8.1 days in the~     FRANCE 2 registry and 10.2 ± 11.1 days in the PARTNER Cohort A data, the UK TAVI registry~     (reference) showed a decline in post-TAVI length of stay from 10 days to 8 days over the time~     period of 2007 to 2012. More contemporary data from other centers has been published showing~     that 23% of TF-TAVI patients were discharged within 3 days after TAVI. With an increasingly~     minimalist approach to TF-TAVI, the duration of monitoring required post-procedure remains~     indeterminate with a lack of formal consensus.~      Early discharge (within 3 days of TAVI) is hypothesized to have multiple potential~     advantages, including reduction in unnecessarily lengthy hospitalization of frail and elderly~     patients in addition to cost-saving benefits. Rouen University Hospital has previously~     published a retrospective study on the feasibility and safety of early discharge, in which~     discharge within 72 hours of uncomplicated TF-TAVI was safe and attained in 36% of our~     patients. Pre-existing pacemaker and the absence of acute kidney injury were independent~     predictors of a successful early discharge. Moreover, in a prospective study, Rouen~     University Hospital recently shown that early discharge afterelective TF-TAVI with~     SAPIEN-XT/SAPIEN-3 prostheses was attainable in a large proportion of patients (59%) with no~     evident compromise in safety. Factors associated with failure of early discharge were~     postprocedural blood transfusion and permanent pacemaker implantation. But currently, there~     are no guidelines for the length of stay after a TF-TAVI.~   "
46600|NCT02956902|"~     This study tests whether people receiving clinician support to use a mobile application on~     their smartphone can manage their post-traumatic stress disorder (PTSD) symptoms better than~     those who do not. Half of the participants will receive the clinician supported smartphone~     application intervention and the other half will remain on the waiting list.~   "
46601|NCT02956889|"~     This is a Fleming-A' Hern, single arm, multicenter, no-profit, phase II study of radiotherapy~     and Vismodegib in adult patients with high risk or locally advanced basal cell carcinoma not~     amenable to radical surgery cell carcinoma (BCC) (comparator: not applicable).~      The recruitment period is expected to be approximately 24 months. The trial will consist of a~     Screening/Baseline period (Day -28 to -1), a Treatment Period when patients will be treated~     with radiotherapy (4 weeks) followed by Vismodegib 150 mg/die continuously for six cycles (24~     weeks).~      The study will end 14 months after start of treatment of the last patient enrolled and~     evaluable according to primary end point.~   "
46602|NCT02956876|"~     With 42,150 new cases per year, colorectal cancer is the third cause of cancer in France~     according to the latest report from the Institut national du Cancer (INCa). Second leading~     cause of cancer death in men, its management is a public health problem. According to~     projections by WHO, the prevalence of cancers expected to increase 50% by 2050 especially in~     digestive oncology. These projections can be concluded that the demand for care will continue~     to be growing.~      Medical advances and societal leading to increased life expectancy, have operated a mutation~     of the cancer disease. Formerly fatal disease, it is now a chronic disease in some cases.~     These changes are causing new challenges for the health system.~      To address this problem, it is asked health professionals to adapt the organization of health~     care delivery to improve efficiency, in a constrained economic environment. To this end,~     action 4.1 of the cancer plan includes the creation of clinical nursing profession, a~     proposal reiterated in article 120 of the French Health System Law. Nursing clinicians will~     be empowered to ensure, under certain conditions, prescription treatments protocolized of~     follow-up tests, further treatment and support, as well as the extension or adaptation of~     specific treatments.~      This project is a first step, in France, in thinking around new organizations in the supply~     of care in oncology.~      For patients, strengthening their monitoring during chemotherapy, will better know their~     tolerance regarding chemotherapy. This optimized management of chemotherapy-induced effects~     will help reduce the use of emergency care.~      The establishment of such a practitioner will free medical time to handle the most complex~     patients and perform tasks related to research.~      For hospital pharmacies this type of organization will optimize their productivity by~     anticipating orders for chemotherapy pockets.~      This project represents an opportunity to demonstrate the added value of advanced practice~     nurses in France in the health system and particularly in oncology. It also adds value to~     clinical expertise nurse and register the profession in the research.~      The hypothesis is that the quality and safety of care provided by a nurse practitioner are~     equivalent to those provided by a doctor at follow-up of patients with gastrointestinal~     cancer, treated with intravenous chemotherapy.~   "
46603|NCT02956863|"~     The purpose of this study is to determine whether manipulative osteopathic treatment~     associated exercises improves pain and function in individuals with chronic non-specific neck~     pain~   "
46629|NCT02956525|"~     Phase I Study to Evaluate the Safety of Dexibuprofen 200mg (Apsen Pharmaceuticals A / S.)~     After a Single and Multiple Dose Oral Administration in Healthy Participants of Both Sexes~     Under Fasting and Fed Conditions.~   "
46606|NCT02956824|"~     Prospective multicenter study assessing the incidence of inflammatory and structural lesions~     seen on MRI of the SI joints in a consecutive population of women aged 18-50 years old.~      The study hypothesis is SpA may be misdiagnosed on MRI in post partum women due to increased~     stress on the joint following pregnancy and childbirth, as MRI of the SI joints may show~     lesions that could mimics axial spondyloarthritis. The primary objective of this study is to~     determine the incidence of SI lesions seen at MRI in women. The secondary objectives are to~     compare the incidence and pattern of MRI inflammatory and structural lesions of the SI joints~     and to determine the factors associated with inflammatory or structural changes of the SI~     joints in a population of women. the investigators will especially compare the population of~     women within a year after childbirth versus the population of women who never gave birth or~     who gave birth over 24 months ago or more.~   "
46607|NCT02956811|"~     Left ventricular hypertrophy (LVH) is common in people with type 2 diabetes (70%) and is the~     strongest independent risk factor for cardiovascular events and all-cause mortality that~     there is. It is worse than triple vessel coronary disease. LVH often occurs in patients with~     normal blood pressures (BP). Apart from BP, the other three main factors causing LVH are~     insulin resistance, obesity and cardiac preload. Dapagliflozin reduces ALL four factors known~     to promote LVH i.e. Dapagliflozin reduces weight, glycaemia, preload and blood pressure and~     is therefore the ideal agent to reduce LVH since it uniquely attacks all four known mediators~     of LVH. This trial will investigate the ability of dapagliflozin to regress LVH in 64~     participants with normotensive diabetes. This will be done by seeing if dapagliflozin reduces~     left ventricular mass as measured by cardiac magnetic resonance imaging (MRI). This trial may~     identify a novel way to reduce the strong independent risk factor of LVH which often persists~     despite optimum medical therapy in patients with diabetes. If dapagliflozin does reduce LVH,~     this would be a key sign of which subgroup of patients with diabetes (those with LVH) should~     be especially targeted with dapagliflozin.~      64 participants with type 2 diabetes and LVH will be recruited through the Scottish Diabetes~     Research Network (SDRN), Scottish Primary Care Research Network (SPCRN) and other routes, in~     this single centre study. Participants will be randomised to receive either 10mg~     dapagliflozin or placebo daily for 12 months. Cardiac MRI will be performed at baseline and~     at 12 months, this will be assessed for the primary outcome of change in left ventricular~     mass. Secondary outcomes will examine change in 24 hour blood pressure and weight.~   "
46608|NCT02956798|"~     The proposed study is a phase II randomized trial testing an innovative concept of comparing~     local therapy to systemic therapy, e.g. pazopanib, in patients with newly diagnosed limited~     metastatic RCC. We hypothesize that local therapy can prolong progression-free survival for~     patients with limited metastasis, and delaying the initiation of systemic therapy does not~     adversely affect survival. Patient will be stratified by Heng's criteria. Patients that are~     curable by metastatectomy as well as patients with poor prognosis and high chance of disease~     dissemination according to the prognostic factors will be excluded.~   "
46609|NCT02956785|"~     The aim of this study is to compare three different regimens for continuation of induction of~     labor after no spontaneous or artificial rupture of membranes could be achieved after first~     24 hours post-insertion of Dinoprostone~   "
46610|NCT02956772|"~     A multicentre, randomized, open-label, parallel-group, active controlled study.~   "
46611|NCT02956759|"~     To compare immediate laser pan-retinal photocoagulation (PRP) treatment of severe or very~     severe non proliferative diabetic retinopathy (NPDR) stage versus deferral of treatment until~     the appearance of any proliferative diabetic retinopathy (PDR) in rural and urban patients in~     China.~      Interview data from some patients and survey data from ophthalmologists in the study~     hospitals will help determine acceptability of early treatment, and how to overcome barriers~     to increased use of this option.~   "
46612|NCT02956746|"~     This is single site, randomized, blinded comparison of the immunogenicity, of Imovax (RVi)~     and Rabavert (RVa) rabies vaccines when subjects are administered rabies immune globulin~     (RIG) or SYN023. Subjects will be randomized into one of four dose groups: RVi + SYN023,~     RVi+RIG, RVa+SYN023 and RVa+RIG. The initial dose of RVi and RVa will be co-administered with~     either RIG or SYN023). Rabies virus neutralizing activity (RVNA) and blood levels of SYN023~     will be measured for the remainder of the trial while the rest of the five RVi and RVa doses~     are given. The study will last 112 days. SYN023 concentrations and anti-SYN023 antibodies~     will also be measured.~   "
46613|NCT02956733|"~     The fasciotomy incisions lead to large, unsightly, chronic wounds after surgical~     intervention. The classic management was split thickness skin grafting but it leads to~     insensate skin with 23% of people upset by the appearance of the wound and 12% forced to~     changed occupation. Since no skin loss has occurred with the fasciotomy and utilizing the~     dermal properties of creep, stress relaxation and load cycling closure can be achieved in a~     better way. Our hypothesis is that using dermatotraction approximation could be done using~     inexpensive equipment readily available in any standard operating room.~   "
46614|NCT02956720|"~     Prospective, open label, self - controlled, single arm, clinical study to assess the~     performance of the UltraShape Power using the U-Sculpt-N on outer thigh and/or flank for~     circumference reduction versus self-control.~   "
46615|NCT02956707|"~     Little is known regarding the incidence and clinical impact of AI in neonates during the~     acute postoperative period following separation from CPB. In a randomized control pilot study~     performed by the UAB CVICU research team, prophylactic post-CPB hydrocortisone infusions~     improved some postoperative outcomes, especially in those that acquired AI7. In an attempt to~     further explore post-CPB AI, a retrospective analysis of data from this study was performed.~     Of the 40 neonates included in the study, one-third (32.5%) developed AI following CPB (as~     determined by low-dose, 1 µg, cosyntropin stimulation test). Almost all of these subjects had~     normal response to cosyntropin stimulation pre-CPB. Subjects that developed AI demonstrated~     more hemodynamic instability, increased serum lactate and required more colloid resuscitation~     in the immediate post-CPB period in the operating room. Recent evidence has begun to~     highlight potential morbidity associated with perioperative steroid administration. Our~     cardiac surgery program is changing clinical practice and ceasing to give preoperative~     steroids to all patients (previously only neonatal CPB patients received preoperative~     methylprednisolone). With the possibility that preoperative steroid administration, and not~     CPB, primarily causes the high incidence of AI, it is prudent to further investigate the~     benefit and/or harm of perioperative steroid administration~   "
46616|NCT02956694|"~     The increasing prevalence of Alzheimer's disease and other forms of dementia causes new~     challenges to ensure that healthcare decisions are informed by research evidence and reflect~     what is important for seniors and their caregivers. Primary care providers point to a need~     for more training on communication with families of seniors living with dementia, and on the~     non-pharmacological health options that are often recommended before use of~     medications.Therefore, the investigators will design and evaluate an intervention to train~     primary healthcare providers on how to empower seniors with dementia and their caregivers in~     making health-related decisions based on research evidence and on their preferences and~     priorities. A distance professional training program on shared decision making will initially~     be designed, comprising evidence summaries to be shared with patients living with dementia~     and their caregivers who face difficult decisions. Patients with dementia, their caregivers~     and healthcare providers, will then provide feedback on the training program, which will then~     be improved following their suggestions. In a last step, the investigators will evaluate~     whether this training program truly increases the participation of patients and their~     caregivers in decision making, their comfort with the decision that they have made, and their~     motivation and ability to control their life by taking care of their own health.~   "
46617|NCT02956681|"~     Recruitment for prevention, and early detection among health disparities populations~     represents a major challenge in chronic disease control. This effect is magnified for~     individuals at high risk for conditions such as genetic breast cancer or chronic hepatitis.~     Costs are typically high, particularly given the common practice of developing a single~     outreach channel to address each disease or condition. In a randomized delayed intervention~     control trial, the investigators tested a strategy to identify low-income women at high risk~     for hereditary breast and ovarian cancer (HBOC) outside the clinical setting and refer them~     to free genetic counseling.~   "
46618|NCT02956668|"~     Homonymous hemianopia is one of the most common symptoms following a neurologic damage and~     has many negative effects on functional abilities and daily activities.~      There are two main kind of restorative rehabilitation of hemianopia: border training, which~     involves exercising vision at the edge of the damaged visual field, and blindsight~     training, which is based on exercising the unconscious perceptual functions in the mild of~     the blind hemifield.~      In literature only border training effects were shown to be facilitated by transcranial~     direct current stimulation (tDCS).~      The investigators treat two patients with blindsight rehabilitation associated to tDCS over~     parieto-occipital cortex. The two patients undergo a cycle of blindsight treatment associated~     to tDCS and a cycle of blindsight training alone in inverted order.~      Aim of the study is to investigate if the anodic stimulation of perilesional areas enhance~     the improvement induced by blindsight rehabilitation treatment.~   "
46619|NCT02956655|"~     The purpose of this study is to evaluate Effect of Fasting Therapy on Blood Glucose Control~     and Islet Function in Newly Diagnosed Type 2 Diabetic Patients.~   "
46620|NCT02956642|"~     This study is a two-arm randomized controlled trial in which participants will receive either~     the Livongo Health system or iHealth glucose meter for measuring their blood glucose. The~     study hypothesizes the use of the Livongo Health system results in a greater improvement in~     A1c compared to standard blood glucose monitoring, as demonstrated by the iHealth~     Bluetooth-enabled glucose meter.~   "
46621|NCT02956629|"~     This is a nonrandomized, multi-site, open-label trial to evaluate a novel two-drug~     combination regimen (uprifosbuvir [MK-3682] 450 mg + ruzasvir [RZR; MK-8408] 180 mg once~     daily [q.d.] for 12 weeks) in male and female treatment-naïve (TN) or treatment-experienced~     (TE) participants with chronic hepatitis C virus (HCV) infection genotype (GT) GT1, GT2, GT3,~     GT4, GT5, or GT6 who have not previously received HCV direct-acting antiviral (DAA) therapy.~     Cirrhotic (C) and non-cirrhotic (NC) participants with and without human immunodeficiency~     virus (HIV) co-infection will be enrolled.~   "
46622|NCT02956616|"~     To determine whether women randomized to an enhanced recovery program will have improved~     postoperative outcomes including improved breastfeeding initiation and continuation,~     reduction in hospital length of stay without compromising patient satisfaction in comparison~     to standard postoperative recovery interventions.~   "
46623|NCT02956603|"~     The primary purpose of this study is to determine the extent to which the Regenerative~     Peripheral Nerve Interface ( i.e. reinnervation of partial muscle grafts by residual~     peripheral nerves) enables both the generation of high-performance motor control signals for~     prosthetic limbs, and the input of sensory percepts by electrical stimulation.~   "
46624|NCT02956590|"~     This trial of pitavastatin will determine efficacy and safety in this high risk population~     and provide evidence for clinicians to target this treatable risk factor to achieve an impact~     on early atherosclerosis, and potentially achieve primary prevention of adult cardiovascular~     disease.~   "
46625|NCT02956577|"~     The purpose of this study is to investigate the influence of micro- and macrovascular changes~     on the cardiac function in relation to left ventricular function and coronary arteries during~     one year in patients with type 2 diabetes.~   "
46626|NCT02956564|"~     Based on multi-center clinical research resources, a large-scale prospective cohort study~     will be conduted to make a more accurate diagnosis and intervention plan of Non-immune fetal~     hydrops (NIFH), and then establish NIFH accurate treatment strategy which is suitable for~     China's national conditions.~   "
46627|NCT02956551|"~     The study is aimed to the test the efficacy and safety of neoantigen-primed dendritic cell~     (DC) cell vaccine therapy for refractory non-small cell lung cancer.~   "
46628|NCT02956538|"~     With the development and application of biological agents, the treatment effect was~     considerable degree improvement on refractory corn's disease. However, there are quite a part~     of the CD patients lost response during treatment of using response. Moreover, due to various~     reasons, there still a lot limited on the using of biological agents in China, that make~     quite a part of the refractory CD patients lack of further medical treatment options. There~     has been a RCT study which prove that thalidomide effect and safety on treating refractory CD~     or who were lost response by using biological agents in Italy, but the object of study is~     only limited in children and adolescents. There are some small sample studies also confirmed~     the efficacy and safety on refractory corn's disease by using thalidomide, but need more RCT~     evidence.~   "
46632|NCT02956486|"~     The name of this trial is MissionAD1. This 24-month treatment, multicenter, double-blind,~     placebo-controlled, parallel group, Phase 3 study in participants with Early Alzheimer's~     Disease (EAD) including mild cognitive impairment (MCI) due to AD/Prodromal AD and the early~     stages of mild AD will be conducted to evaluate the efficacy and safety of elenbecestat~     (proposed international nonproprietary name [INN]) (E2609).~   "
46633|NCT02956473|"~     This research study involves the use of a common breast imaging modality (magnetic resonance~     imaging, 'MRI') and is investigating its role in evaluating treatment for breast cancer when~     it is performed with the patient in a new position (lying on one's back) as opposed to in the~     standard position (lying on one's stomach).~   "
46634|NCT02956460|"~     Prospective, multi-center, bilateral, double-masked, randomized, cross-over, daily wear, 1~     month dispensing study (2 weeks each lens pair)~   "
46635|NCT02956447|"~     The goal of this project is to explore the use of exogenous pulsatile kisspeptin as a~     therapeutic alternative for patients with hyperprolactinemia who are intolerant to current~     therapies.~   "
46636|NCT02956434|"~     This study aims to test a brief family intervention (the BFI) to enhance~     individually-delivered PTSD treatment for Veterans.~   "
46637|NCT02956421|"~     Phase II clinical study for an investigational PIKA(Polyinosinic Polycytidylic Acid Based~     Adjuvant) rabies vaccine comprising Inactivated and Purified Rabies Virus (IPRV) and the PIKA~     adjuvant. The primary objective of the study is to evaluate the efficacy and safety profile~     of the vaccine composition in healthy adult volunteers under the accelerated regimen. The~     secondary objective is to achieve higher seroconversion of the vaccine under accelerated~     regimen at Day 7.~   "
46638|NCT02956408|"~     Vitamin D deficiency is common in the general population in the United States, but is more~     common in overweight and obese children. Additionally, vitamin D levels are inversely~     correlated with body mass index, hypertension, inflammatory markers and insulin resistance.~     There are currently no clear guidelines regarding vitamin D replacement in obese but~     otherwise healthy children. The Endocrine Society recommends that children with vitamin D~     deficiency should take 2000 IU once a day for at least 6 weeks; however, they state that~     obese children may need 2-3 times this dose in order to reach sufficient levels.~      The goals of this study are:~        1. To determine the prevalence of vitamin D sufficiency (>30 ng/mL), insufficiency (21-29~          ng/mL); deficiency (10-19 ng/mL) and severe vitamin D deficiency (<10 ng/dL) in an obese~          pediatric population (2-11 years) as measured by 25-hydroxyvitamin D.~        2. To determine if vitamin D level correlates with percentage body fat by bioelectrical~          impedance analysis and/or visceral fat by waist circumference in children ages 5 - 11~          years.~        3. To observe the effect of vitamin D replacement in obese children with vitamin D~          deficiency using two different replacement dosage levels recommended by the Endocrine~          Society over three months: 2000 IU once a day (general pediatric dose) vs 6000 IU once a~          day (suggested obesity dose) in children between the ages of 5 - 11 years.~        4. To measure vitamin D levels, bone markers, inflammatory markers and vitamin D binding~          protein before and after vitamin D supplementation in children between the ages of 5 -~          11 years. Analysis will be stratified by degree of obesity (Class I, Class II, Class~          III) and season.~   "
46639|NCT02956395|"~     Background/Aims: Large scale adoption of integrated care for chronic patients constitutes a~     key milestone to accelerate adaptation of current healthcare systems to the evolving needs~     triggered by population ageing and high prevalence of chronic conditions. Lessons learnt from~     deployment experiences are being disseminated as good practices. But, there is need for~     further assessment of implementation strategies in real world scenarios. Moreover, progresses~     achieved in disease-oriented integrated care cannot be automatically transferred to~     management of complex chronic patients (CCP). The protocol addresses five aims: 1)~     implementation of two integrated care interventions using a collaborative and adaptive case~     management (ACM) approach (i) Community-based management of CCP; and, ii) Integrated care for~     patients under long-term oxygen therapy (LTOT)); 2) adoption of information and communication~     technologies (ICT) required to support collaborative ACM; 3) to evaluate the impact of~     enhanced clinical health risk assessment and stratification; 5) to generate a roadmap for~     regional adoption of the CCP program.~      Methods/Design: the CCP program will be deployed in three healthcare sector of~     Barcelona-Esquerra (AISBE) (520 k citizens) and in two other areas of Catalonia: Badalona~     Serveis Assistencials (BSA) (420 k citizens) and Lleida (366 k citizens) following~     Plan-Do-Study-Act iterative cycles, using the Model for Assessment of Telemedicine for~     evaluation purposes. The study also addresses the steps for scale-up of integrated care in~     the entire Catalan region (7.5 M citizens). Observational studies with matched controls have~     been planned for both Community-based management of CCP (n=3.000) and for Integrated care for~     patients under LTOT (n=500). Moreover, clustered randomized controlled trials (RCT) are~     planned on top of the observational studies to test specific questions (i.e. performance of~     the ICT platform providing ACM functionalities). Main components of CCP program are: a)~     patient stratification; b) comprehensive assessment strategies; c) ICT supported adaptive~     Case management; d) Roadmap for regional adoption.~      Hypothesis: the CCP program will generate guidelines for large scale deployment of the CCP~     program, including transferability analysis, facilitating adoption of integrated care~     services for management of multi-morbidity.~   "
46640|NCT02956382|"~     This is a phase I/II study in which patients will be enrolled in a standard 3+3 design. Once~     the maximum tolerated dose (MTD) is determined amongst patients with relapsed or refractory~     grade 1-3a follicular lymphoma, there will be a 17-patient phase II study.~   "
46641|NCT02956369|"~     SATIOSTAT is a composition comprising a specific dietary fibre component (a mixture of~     hydrocolloids with excellent safety profiles and a long history of use in humans) and a lipid~     component (long-chain fatty acids). The goal of this combination is to achieve long-acting~     delivery of long-chain fatty acids to the intestinal lining, triggering the sustained release~     of satiety-signals from intestinal cells, and consequently reducing appetite and lowering~     food intake in humans.~      Over a period of 6 weeks, volunteers will ingest SATIOSTAT as meal replacement at lunch and~     as first course at dinner. Once before and after these 6 weeks the investigators will carry~     out an oral glucose challenge, measure satiation hormones and examine faeces (gut~     microbiota). Volunteers will fill in a food diary and a questionnaire for gastrointestinal~     symptoms and quality of life. The whole study will take approximately 8-10 weeks.~   "
46674|NCT02955940|"~     The purpose of this study is to provide continued supply of ruxolitinib alone, ruxolitinib~     plus background cancer therapy, or background cancer therapy alone to subjects from an~     Incyte-sponsored study of ruxolitinib that has reached its study objectives or has been~     terminated.~      This study will also provide another mechanism for reporting adverse events related to study~     drug safety.~   "
46703|NCT02955563|"~     The goal is to develop a pragmatic, scalable intervention to overcome problems with surrogate~     decision making in ICUs.~      The aim is to conduct a pilot study among 100 surrogates and clinicians of incapacitated~     patients at high risk of death to assess the feasibility of deploying the web-based tool as~     well as to examine the tools impact on the patient and family outcome measures summarized in~     the hypotheses below.~   "
46642|NCT02956356|"~     SATIOSTAT is a composition comprising a specific dietary fibre component (a mixture of~     hydrocolloids with excellent safety profiles and a long history of use in humans) and a lipid~     component (long-chain fatty acids). The goal of this combination is to achieve long-acting~     delivery of long-chain fatty acids to the intestinal lining, triggering the sustained release~     of satiety-signals from intestinal cells, and consequently reducing appetite and lowering~     food intake in humans.~      Effects of acute ingestion of SATIOSTAT vs. a control will be examined. On a first and second~     study day, volunteers receive a preload of either SATIOSTAT or a control and then an oral~     glucose load of 75g enriched with C13 sodium acetate. Gastric emptying will be measured by~     means of a breath test, and insulin, glucose and satiation hormones will be assessed. On the~     third and fourth study day, volunteers receive a preload of either SATIOSTAT or a control and~     are then presented a test meal. Total calorie intake is measured as well as subjective~     feelings of satiation. In addition satiation hormones are measured.~   "
46643|NCT02956343|"~     In this trial the Preventives Heartbeats algorithm will be tested in two wearable devices for~     its specificity and sensitivity to distinguish between AF and SR.~   "
46644|NCT02956330|"~     The purpose of this non interventional retrospective study is to continue to collect data~     from patients following their completion of Protocol CLS 1003-201: Safety and Efficacy of~     Suprachoroidal CLS-TA with Intravitreal Aflibercept in Subjects with Macular Edema Following~     Retinal Vein Occlusion (ie, the parent study).~   "
46645|NCT02956317|"~     This is a randomized, double-blind, within-subject placebo controlled study to evaluate the~     safety and efficacy of various doses of STP705 administered as intradermal Injection in~     subjects with hypertrophic scar. The goals are to determine the recommended Phase 2 dose, the~     pharmacokinetics and pharmacidynamics parameters, and conduct analysis of biomarkers common~     to the scar formation pathway.~   "
46646|NCT02956304|"~     The purpose of this study is determine the involvement of motor system in the memory of~     manipulable objects. The idea is to stimulate the ventral premotor cortex with transcranial~     magnetic stimulation to see whether this stimulation will affect memory of manipulable~     objects.~   "
46647|NCT02956291|"~     The purpose of the research study is to test new methods that could improve diagnosis and~     assessment of brain tumors. One of these methods is a new MR (magnetic resonance) imaging~     technique called magnetic resonance fingerprinting (MRF), which allows for rapidly scanning~     the patient and provides quantitative information on tumor tissue. The investigators will~     compare the data gathered from MR Fingerprinting with other imaging tests, clinical~     information, treatment details and biopsy results to evaluate the accuracy of this new~     technique.~   "
46648|NCT02956278|"~     Subjects will undergo a placebo and allopurinol phase to better understand the effects of the~     reduced function BCRP Q141K variant on allopurinol pharmacokinetics and pharmacodynamics.~   "
46649|NCT02956265|"~     Actinic keratosis are of utmost medical and economical interest because of their high~     prevalence (20 % of 60 year-old people and older in the Northern hemisphere) and their~     important cosmetic impact as such actinic keratosis mostly appear on photo-exposed skin~     sites. The surgeon in charge of such lesions' removal (i) some actinic keratosis adjoining~     carcinoma to be resected therefore causing the problem of functional areas damaging (eyelids,~     lips, etc.) or (ii) numerous actinic keratosis localized away from carcinoma~     (photo-carcinogenesis field) faces the issue of clinical evaluation of such lesions: which~     ones will spontaneously regress (it is supposed to be the case for 20 % of such~     lesions);which ones will remain and which ones will develop into invasive carcinomas ?~      A non-invasive, non-traumatic, automated and real-time help for the clinical diagnosis~     orientation of such skin lesions could help improving diagnosis accuracy of the medical~     practitioner's visual inspection:~        -  In terms of sensitivity in order to potentially decrease the number of actinic keratosis~          evolving towards invasive carcinoma,~        -  In terms of specificity in order to potentially decrease useless resections and reduce~          resection margins and therefore reduce scars surface.~   "
46650|NCT02956252|"~     The aim of this study is to compare early postoperative outcomes of unselected consecutive~     patients underwent laparoscopic cholecystectomy (LC) under spinal versus general anesthesia.~   "
46651|NCT02956239|"~     This project will develop, test and produce a lightweight, cordless, battery driven and~     rechargeable hand-held device for treating cervical precancer (Liger Thermal Coagulator). The~     study will evaluate its effectiveness compared to the current standard treatment~     (cryocautery) when used as part of a screen and treat programme using Visual Inspection with~     Acetic acid (VIA) in Sub Saharan Africa.~   "
46652|NCT02956226|"~     This study aims to assess the safety, tolerability and efficacy of cannabinoids mix~     [cannabidiol (CBD), Δ9-tetrahydrocannabinol (THC) in a 20:1 ratio] for behavioral problems in~     children and youth with ASD.~   "
46653|NCT02956213|"~     The investigators will conduct a randomized, controlled, double-blind, crossover trial to~     determine whether the presence of a portable high-efficiency indoor air filter in the bedroom~     reduces respiratory symptoms in former smokers compared with placebo. The primary outcomes~     will be change in St. George's Respiratory Questionnaire - COPD (SGRQ-C) score associated~     with using a portable high-efficiency indoor air filter during the study period. Secondary~     outcomes of COPD exacerbations and hospitalizations, daily step counts, medication changes,~     spirometry, and cardiovascular outcomes will also be assessed.~   "
46654|NCT02956200|"~     Proof-of concept clinical trials have indicated that the sphingosine-1-phosphate receptor~     modulator fingolimod may be efficacious in attenuating brain inflammation and improving~     clinical outcomes in patients with AIS as a single therapy beyond 4.5 hours of disease onset,~     or in combination with alteplase within 4.5 hours of disease onset. So in this study the~     investigators try to determine whether the addition of fingolimod, administered within 6~     hours after the onset of symptoms in patients receiving alteplase bridging with mechanical~     thrombectomy, improves radiologic and clinical outcomes.~   "
46692|NCT02955706|"~     clinical trial to assess the efficacy of Acetyl-L-carnitine~   "
46693|NCT02955693|"~     The purpose of this study is to determine how the organism affects MMF (metabolite of~     dimethyl fumarate [DMF]) after single oral dose administration of LAS41008 120 mg~     gastroresistant tablet and Fumaderm® 120 mg gastro-resistant tablet under fasting and fed~     conditions. The study also aims to assess the safety of the study treatments.~   "
46655|NCT02956187|"~     Background. Functional dyspepsia is characterized by symptoms that apparently originate in~     the stomach without detectable cause by conventional diagnosis test. The pathophysiology of~     functional dyspepsia is not known, but a number of data indicate that dyspeptic patients have~     increased sensitivity of the digestive system, so that physiological stimuli may induce their~     symptoms. Some patients with functional dyspepsia have also functional constipation and the~     investigators hypothesize that in them constipation triggers or facilitates dyspeptic~     symptoms, and consequently, correction of constipation relieves dyspeptic symptoms.~      Objective. To demonstrate the superiority of biofeedback versus a fiber supplement for the~     treatment of dyspeptic symptoms in patients with constipation due to functional outlet~     obstruction.~      Design. Randomized, controlled parallel trial performed in a referral center. Participants.~     Consecutive patients complaining of symptoms of functional dyspepsia and functional outlet~     obstruction.~      Interventions: Patients will be assigned to experimental (biofeedback for functional outlet~     obstruction) and active comparator (fiber supplementation) arms. Biofeedback for functional~     outlet obstruction: sessions of biofeedback guided by anorectal manometry (performed during~     the first 3 weeks of the intervention period) combined with instructions for daily exercising~     for 4 weeks. Fiber supplementation: 2.5 g plantago ovata per day for 4 weeks. Main outcome~     and measures. Clinical symptoms of functional dyspepsia measured by daily questionnaires for~     7 consecutive days before and during the last week of intervention.~      Relevance. Functional Dyspepsia, defined by purely clinical criteria, brings together a~     diverse group of conditions with different pathophysiology. As a result, the treatment is~     empirical and globally inefficient. This study will identify a subset of patients with a~     common pathophysiological mechanism of dyspeptic symptoms (functional outlet obstruction)~     which respond to specific treatment (biofeedback).~   "
46656|NCT02956174|"~     Objectives - To evaluate the 4-year clinical outcomes of ceramic veneered Computer Aided~     Design/Computer Aided Manufacturing (CAD/CAM) Co-Cr single crowns supported by natural teeth~     in posterior regions.~      Material and methods - Eighty-nine patients were provided with 120 ceramic veneered CAD/CAM~     Co-Cr single crowns replacing either premolars and molars. Specific inclusion criteria were~     needed and tooth preparations were standardized and performed by 2 expert prosthodontists.~     CAD/CAM Co-Cr frameworks were fabricated and veneered with ceramics. The restorations were~     cemented using a eugenol-free zinc oxide luting agent. The patients were recalled after 1, 6,~     12, 24, 36 and 48 months. The survival and success of the restorations were evaluated. The~     technical and esthetic outcomes were examined using the United States Public Health Service~     criteria. The biologic outcomes were analyzed at abutment and contralateral teeth and~     descriptive statistics were performed.~   "
46657|NCT02956161|"~     This monocentric, cross-over, randomised, double blind and placebo-controlled study evaluates~     the effects of auditory stimulations of the sleep slow oscillation on deep sleep quality.~   "
46658|NCT02956148|"~     The aim of this study is to measure longitudinally the availability of the PDE10A enzyme in~     HDGECs using the radioligand [18F]MNI-659. The study will be a follow-up, examining HDGECs~     from the CHDIKI1201/PET-HD-PDE10A (NCT02061722) study from 18 to 28 months after the initial~     PET measurement.~   "
46659|NCT02956135|"~     The aim of this study is to assess the relationship between the presence of overuse injuries~     and failure to control of movement in those areas. For this, participants will perform some~     tests related to movement dysfunction lumbar-pelvic area to check for faults in one or more~     movement planes.~   "
46660|NCT02956122|"~     The purpose of the study is to evaluate the safety and efficacy of GLASSIA as an add-on~     biopharmacotherapy to standard-of-care steroid treatment as the first-line treatment in~     participants with acute GvHD with lower GI involvement.~   "
46661|NCT02956109|"~     Finerenone is developed for the treatment of diabetic kidney disease (adults) and chronic~     kidney disease (children). The purpose of the proposed trial is to test the pharmacokinetics~     of a single oral dose of finerenone (1.25 mg tablet and 5 x 0.25 mg tablets) using a novel~     orodispersible tablet formulation for the treatment of children, in comparison to the adult~     tablet formulation.~   "
46662|NCT02956096|"~     Introduction: Patients post-stroke may have autonomic dysfunction, with increased blood~     pressure, heart rate (HR) and increased risk of sudden death. Studies have shown that~     transcranial direct-current stimulation (tDCS) can modulate the autonomic nervous system in~     healthy subjects, but little is known about these effects in stroke.~      Objective: To evaluate the effect of tDCS after treadmill training in the autonomic nervous~     system modulation in patients post-stroke.~   "
46663|NCT02956083|"~     The primary goal of this investigation is to determine if lipid based artificial tear~     supplementation has an impact on contact lens discomfort (CLD).~   "
46664|NCT02956070|"~     Clinical randomized, triple-blind, used to measure the level of tooth sensitivity on~     volunteers using a modified virtual analog scale (VAS). Sixty-six volunteers will be selected~     and recruited, following inclusion criteria and pre-established exclusion. All volunteers~     will be guided and sign a term of clarification and consent. Volunteers will be randomly~     divided into two groups: the control group to receive placebo capsules and application of~     desensitizing gel containing 6% potassium nitrate and 0.10% fluoro- (conventional treatment)~     and the experimental group will receive the anti-inflammatory corticosteroids (dexamethasone,~     capsule - 8mg) and application of a placebo gel. Patients will be treated in two clinical~     sessions with an interval of 7 days (one week) between them. The protocol for use of the~     product is as follows: The volunteers in the experimental group will receive six capsules of~     dexamethasone 8 mg each to be administered orally, initially two days before the first~     bleaching query as follows: 8 mg (1 capsule) 9 am in the morning two days before the first~     clinical session whitening; 8 mg (1 capsule) the 9 am to 1 day before the first practice~     session whitening, 8 mg (1 capsule) to 9 am on the day of the first practice session of~     whitening. After 7 days (one week), the same protocol will be held for the second and final~     practice session office bleaching.~   "
46665|NCT02956057|"~     Study evaluates the efficacy and tolerability of low volume preparations compared with~     conventional 4L polyethylene glycol prior to colonoscopy~   "
46666|NCT02956044|"~     The purpose of this study is to examine the drug-drug interaction in your body when given the~     study drug, bexagliflozin, with three commonly used ant-diabetic medications, metformin,~     glimepiride or sitagliptin. The study will also evaluate how safe the study drug is and how~     well the study drug is tolerated when taken with metformin, glimepiride or sitagliptin.~   "
46694|NCT02955680|"~     Mother spend a large amount of time with their children. It is assumed that mother~     contributes to their neurological development not only with visual stimuli, but also with~     auditory stimuli. A recent study revealed that prefrontal cortex can be activated in response~     to the self-name being spoken by the mother than by a stranger. Therefore, investigators~     suppose that recorded maternal voice can stimulate the pediatric patients and thereby fasten~     the emergence from general anesthesia.~   "
46667|NCT02956031|"~     Nearly 8 000 new cervical cancer cases are diagnosed in South Africa per year; many are still~     undiagnosed and about 50% of diagnosed cases succumb per year. Although the current~     prevalence of pre-cancer cervical disease is largely unknown, data from local studies suggest~     regional differences and an increase in the prevalence of cytological abnormalities when~     compared with historical data. Low frequency in cytology screening is the primary factor~     attributable to development of invasive cervical cancer and almost one-third of all cervical~     cancer patients had previous negative cytology. Due to the low sensitivity of cytology it can~     be assumed that the true prevalence of pre-cancer disease is underestimated by all available~     data. One round of optimal cervical cytology will detect around 50% of existing pre-cancer~     cervical disease as identified and proven using colposcopy and directed biopsy. It is now~     widely accepted that primary screening with a human papilloma virus (HPV) test can improve~     the sensitivity of screening and that even a single round of HPV screening can rapidly reduce~     the incidence of invasive cervical cancer and related mortality within a few years.~      South Africa has a high prevalence of HIV infection and a delay in or failure to initiate~     antiretroviral therapy (ART). These facts, together with the largely unscreened status of the~     female population and the high incidence of cervical cancer all suggest that HPV infection~     and precursors to cervical cancer are both unusually common among South African women.~     Accurate current knowledge of the performance of newer generation HPV based screening tests~     in HIV-infected and general female population are essential for cost-analysis and planning~     for national prevention and screening programs. This study will aim to demonstrate the~     feasibility and efficacy of new generation HPV deoxyribonucleic acid (DNA) based screening~     assays in a South African setting.~      The investigators hypothesize that HPV testing followed by normal and special cytology tests~     will be a successful screening model for a South African population.~   "
46668|NCT02956018|"~     Kidney transplant thrombosis (loss of blood flow) is responsible for up to 35% transplant~     failures in children. Detection of kidney transplant thrombosis currently relies on~     recognition of deterioration in parameters such as urine output and blood creatinine levels,~     which change relatively slowly. Confirmation is then required with an ultrasound scan. There~     is inherent delay in the above process, during which time some or all of the transplant~     kidney tissue can die, which can result in failure of the transplant.~      Near infrared spectroscopy (NIRS) is a non-invasive technique used in continuous monitoring~     of oxygen levels in several organ systems including the brain, muscles, gut, liver and native~     kidneys. We hypothesise that NIRS can be applied to monitor kidney transplant blood flow in~     real time.~      We aim to test the use of NIRS in detecting blood flow in established kidney transplants in~     children, and to compare it with ultrasound, the current gold standard measurement. Existing~     NIRS equipment would be used within its CE marked purpose measuring oxygen levels; this~     mechanistic study would extrapolate measured oxygen levels to determine blood flow.~     Participating children attending outpatient clinic for routine transplant ultrasound scans~     will have NIRs monitoring for a 10 minute period. NIRs data will be compared to a validated~     perfusion score from ultrasound images.~      If this study is successful, NIRS could provide continuous monitoring of kidney transplant~     blood flow in the postoperative period, thus allowing immediate detection of blood flow~     problems. This has potential to reduce kidney transplant failures from thrombosis.~   "
46669|NCT02956005|"~     The purpose of this study is to collect data prospectively on African American patients who~     are taking the immunosuppressant Envarsus post kidney transplant. We are looking to see if~     African American renal transplant recipients that receive Envarsus will have less tubular~     injury and calcenurin inhibitor toxicity compared with patients that receive tacrolimus IR.~      African americans have the higher rates of CYP3A5 which is associated with the need of higher~     tacrolimus dose to achieve an adequate level and this many times is associated with signs and~     symptoms of tacrolimus toxicity such as tremors, headaches and neuropathies.~      The retrospective cohort will be African American patients that will be matched by age,~     gender, type of kidney transplant (living vs deceased) and level of sensitization~   "
46670|NCT02955992|"~     As ICU mortality is high, end-of-life is a subject of major concern for intensivists. With a~     mortality rate of 20%, end-of-life care has become a daily responsibility. Among those~     deaths, 60 to 80% follow a decision to withhold or withdraw treatment, situations where~     physicians, nurses and relatives must work together towards the most consensual decision. In~     this context, patients' relatives feel vulnerable and, in the months that follow the death,~     they are most likely to present symptoms that negatively affect their quality of life~     (anxiety, depression, PTSD, prolonged grief). Many studies have shown that communication with~     caregivers is one of the most highly valued aspects of care that impacts on family members'~     experience during the patient's stay and after the patient's death. Improving communication~     during the end-of-life process in the ICU context is a necessity that has been put forward in~     palliative care and family-centered care guidelines.~      This study aims to improve both communication skills and behaviour by giving precise~     recommendations to physicians (3 step strategy) in their direct contact with patients'~     relatives. A 3-step physician-driven support strategy is used, that consists in 3 meetings~     with the relative - one before, one during and one after the patient's death. The underlying~     hypothesis is that this strategy will improve communication in the end-of-life setting and~     thus should reduce post-ICU burden for family members, specifically the development of~     prolonged grief 6 months after the death.~   "
46671|NCT02955979|"~     Iodinated contrast media are now frequently used in diagnostic imaging exams, including~     pediatrics.~      In adults, the acute renal failure (ARF) associated with contrast agents (CA-AKI) occur in~     3-33% of exposed patients, especially as the patient is fragile, has comorbidities or~     pre-existing renal aggression .~      In children, the prevalence of this little known disease is probably underestimated.~      The investigators intend to conduct a prospective epidemiological study, to estimate the~     impact of the acute renale failure to iodinated contrast agents in pediatrics.~   "
46672|NCT02955966|"~     OPTIFIL is a pilot prospective multicenter study based over the hypothesis that the~     normalization of the functional imaging 18F-FDG-PET/CT during the Invasive pulmonary~     aspergillosis (IPA) could occur earlier than that of conventional imaging.~      This study evaluates the therapeutic response through a systematic 18F-FDG-PET/CT at week 6.~     The latter response will be correlated with the kinetics of selected biomarkers including~     antigens (galactomannan, β-D glucans), circulating Aspergillus DNA and anti-Aspergillus host~     response markers in addition to the conventional imaging tools obtained at weeks 6 and 12.~   "
46673|NCT02955953|"~     The study will aim to evaluate the following:~        -  Whether there are any differences in the way the body handles LY2963016 U-200 and~          LY2963016 U-100.~        -  How well-tolerated LY2963016 U-200 is compared with LY2963016 U-100.~        -  How LY2963016 U-200 affects the level of blood sugar in the body compared with LY2963016~          U-100.~      The study will last up to 17 weeks for each participant, including initial screening and~     follow up.~   "
46675|NCT02955927|"~     This study aims to compare effects in retardation of myopia progression of combined ortho-k~     and 0.01% atropine therapy with those of ortho-k alone.Myopia control methods mainly focus on~     optical and pharmaceutical interventions . Currently, overnight-wear orthokeratology~     (ortho-k), is used extensively in Hong Kong with approximately 50% retardation effect.~     Pharmaceutical methods have focused on the use of atropine eye drops to slow myopic~     progression.The use of 1% atropine was limited by the manifestation of side effects and~     rebound effect.However, both side effect and rebound effect was minimal with 0.01%~     atropine.It was suggested that 0.01% was the optimum concentration for controlling myopia.The~     mechanisms of neither ortho-k nor atropine in myopia control are fully understood.It is~     believed that ortho-k and atropine act via different mechanisms.It is possible that by~     combining these two methods, additional retardation of myopia progression could be achieved.~   "
46676|NCT02955914|"~     Before a heart operation, patient outlook may be either pessimistic or optimistic. Previous~     research on this topic has focused on patient reported quality of life but has never examined~     measurable clinical outcomes such as length of hospital stay.This pilot study hopes to~     establish whether patient outlook (optimistic or pessimistic) before a heart operation can~     influence recovery and length of hospital stay. If there is a difference, then a case can be~     made for providing psychological support before an operation in the hope of modifying outlook~     and thus improving patient care and reducing hospital stay and NHS costs. Patients will be~     recruited over a 12month period. Their outlook (pessimistic or optimistic) will be~     ascertained using two standardised questionnaires. Their recovery and length of stay will be~     recorded. The study will answer the research question and determine whether outlook has an~     impact on recovery. Depending on the results, this study could provide opportunities for~     additional future research into modifying outlook with a view to improving patient care and~     recovery.~   "
46677|NCT02955901|"~     Colonoscopy is one of the most common methods for the diagnosis and treatment of lower~     gastrointestinal tract diseases and provides a unique opportunity to identify early~     neoplastic lesions.~      Adequate bowel preparation is important for optimal colonoscopy. New bowel-cleansing~     regimens, study of patient-related risk factors to fail a proper preparation and diet~     adaptations have been studied recently.~      A low residue diet is the standard in the day before the colonoscopy. Some endoscopists~     prescribe this dietary plan for a 3-day period prior to the exam, although no study compared~     the recommended 1-day versus 3-day diet regime, or the influence in bowel preparation~     results.~      The aim of this project is to determine if the use of a 3-day low residue diet improves bowel~     preparations results and the influence in patient tolerability and adherence.~   "
46678|NCT02955888|"~     This is a Phase 2, multi-center, double blind, placebo controlled study to evaluate the~     safety and tolerability of PBI-4050, and its effects on the pancreatic, pulmonary functions~     and on various biomarkers in Cystic Fibrosis patients with abnormal glucose tolerance.~     Patients with abnormal glucose tolerance have elevated glucose level either at 1 hour or 2~     hour during an Oral Glucose Tolerance Test (OGTT). The Main study will include 24 weeks of~     treatment with PBI-4050 or matching placebo. At the end of the treatment period, patients~     will have the option of participating in a 24-week Extension study.~   "
46679|NCT02955875|"~     The purpose of this study is to examine the effectiveness of pharmaceutical care service in~     the management of poorly controlled type 2 diabetes mellitus.~   "
46680|NCT02955862|"~     CRICS financial report for the first budget year of the study~   "
46681|NCT02955849|"~     Aims and Objectives (Quantitative) Aim: To compare the effectiveness of selective laser~     trabeculoplasty with trabeculoplasty in lowering the intraocular pressure in patients with~     medically uncontrolled open angle glaucoma in rural China, taking into account the impact of~     patient acceptance of each type of treatment~      Hypothesis: Mean intraocular pressure after treatment with selective laser trabeculoplasty~     will be lower than with surgery due to higher acceptance rates among patients randomized to~     receive this treatment and therefore treatment provided at an earlier stage of disease~     progression.~   "
46682|NCT02955836|"~     Objective: The purposes of this study are 1) to understand the nurses' need and perception~     toward of the monitoring information system of nursing-related patient safety and quality~     indicators; 2) to establish the monitoring information system of nursing-related patient~     safety and quality indicators; 3) to evaluate the monitoring information system of~     nursing-related patient safety and quality indicators.~      Methods: There will be three phases and the study site in the medical center in northern~     Taiwan. The first phase is information needs assessment. Researchers will hold the meeting of~     focus group discussion. The subjects will be the nursing manager, head nurse, clinical nurses~     who are similar to nursing-related patient safety and quality indicators. The self-conducted~     semi-structure discussion form will be used to collect the data during the meeting of focus~     group discussion. The questionnaire will be used to collect the perception, attitude,~     behavior, satisfaction, time-consuming and the accuracy of nursing-related patient safety and~     quality indicators data from nurses. The second phase will establish the monitoring~     information system of nursing-related patient safety and quality indicators and clinical~     implementation. The third phase will evaluate the effectiveness of the monitoring information~     system of nursing-related patient safety and quality indicators. The questionnaire will be~     used to collect the satisfaction, time-consuming and the accuracy of nursing-related patient~     safety and quality indicators from nurses during the evaluation phase.~   "
46683|NCT02955823|"~     A phase II study to evaluate the combination of Lenalidomide and Rituximab as front line~     therapy for the treatment of elderly frail patients evaluated in CGA with Diffuse Large~     B-cells non-Hodgkin Lymphoma.~   "
46695|NCT02955667|"~     This study intends to carry out a prospective, randomized controlled trial to research and~     development a new invivo microscopy based on the technology which is combined with~     high-definition microscopy and colposcopy，so as to diagnose cervical lesion directly and~     non-invasively by observing cervical tissues and cells, which makes it possible to diagnose~     cervical cancer without wounds.~   "
46696|NCT02955654|"~     The purpose of this study is to determine whether acceptance and commitment therapy is~     effective in the treatment of SSRIs-resistant obsessive- compulsive disorder.~   "
46697|NCT02955641|"~     The purpose of this study is to evaluate the efficacy and need for prescribing~     anti-inflammatory topical drops to patients undergoing laser peripheral iridotomy.~   "
46684|NCT02955810|"~     This study is a Phase Ib open label, single arm, adaptive multicentre trial. Patients with~     newly diagnosed Multiple Myeloma (MM) will be treated with~     Cyclophosphamide-Bortezomib-Dexamethasone (CyBorD) in combination with Daratumumab (DARA).~      The safety profile of daratumumab to date, which does not appear to overlap with those known~     for approved agents, combined with its distinct MoA, suggest that the therapeutic profile of~     daratumumab combined with various backbone regimens may improve the treatment effect of these~     regimens. Additionally, daratumumab as a single agent may prolong the progression free~     interval for these patients. Based on the potential for cyclophosphamide to enhance ADCP,~     there is a strong rationale to combine DARA with a cyclophosphamide, bortezomib containing~     regimen. This will be the first clinical trial to explore the feasibility of combining~     daratumumab with a cyclophosphamide containing backbone induction regimen and if successful~     will provide the rationale for larger studies exploring the efficacy of this combination in~     greater detail.~   "
46685|NCT02955797|"~     The purpose of the study is to evaluate the quadrivalent meningococcal conjugate vaccine when~     used as a single-dose toddler vaccine in individuals who are either meningococcal vaccine~     naïve or have received one or more doses of monovalent meningococcal C (MenC) vaccines during~     infancy.~      Primary Objectives:~        -  To demonstrate the non-inferiority of the antibody response to meningococcal serogroups~          A, C, Y, and W after a single dose of MenACYW conjugate vaccine or Nimenrix® in toddlers~          who either are meningococcal vaccine naïve or have received monovalent MenC vaccination~          during infancy~        -  To demonstrate the non-inferiority of the antibody response to meningococcal serogroups~          A, C, Y, and W after a single dose of MenACYW conjugate vaccine or Nimenrix® in~          meningococcal vaccine naïve toddlers~      Secondary Objectives:~        -  To compare the antibody responses (geometric mean titers [GMTs]) to meningococcal~          serogroups A, C, Y, and W after a dose of MenACYW conjugate vaccine or Nimenrix® as~          measured by hSBA in toddlers who either are meningococcal vaccine naïve or have received~          monovalent MenC vaccination during infancy~        -  To compare the antibody responses (GMTs) to meningococcal serogroups A, C, Y, and W~          after a dose of MenACYW conjugate vaccine or Nimenrix® as measured by hSBA in~          meningococcal vaccine naïve toddlers~        -  To compare the antibody responses (GMTs) to meningococcal serogroups A, C, Y, and W~          after a dose of MenACYW conjugate vaccine or Nimenrix® as measured by hSBA in toddlers~          who received monovalent MenC vaccination during infancy.~      Observational Objective:~        -  To evaluate the safety profile of MenACYW conjugate vaccine and Nimenrix®.~   "
46686|NCT02955784|"~     The investigators are proposing a prospective one-arm cohort study testing the feasibility of~     a game designed to improve symptoms in adults with mild levels of stress, depression, and~     anxiety. The study will take place at Madigan Army Medical Center. Primary outcomes include~     usage data including time, frequency and duration of app use, participant satisfaction with~     the game, and comments and suggestions regarding participants' experiences using the~     Sinasprite game over a 12-week period. Participants will download Litesprite's game,~     Sinasprite, onto their personal smartphone. Elements of cognitive-behavioral therapies like~     cognitive strategies, diaphragmatic breathing, and visualization are embedded in the game~     enabling participants to learn to achieve the desired healthy habits. The game's goal is to~     help Socks the Fox become a Zen Master. Over six weeks, players help Socks to progress by~     describing and categorizing their concerns, entrusting Socks to hold these concerns, and~     engaging in bonding activities with Socks, such as fishing and meditation. The investigators~     currently have a prototype and have been told by insurance firms, providers, and self-funded~     employers that they need to see validated results from a pilot study that shows feasibility~     with subjects in the target audience before they can consider a commercial roll out.~     Participants will complete questions related to mood, stress, and well-being at baseline, 6~     weeks, and 12 weeks. Data will be evaluated in real-time and reports of participant progress~     will be provided to the participant's provider, with the participant's consent. Data and~     feedback from this pilot study will be used to update the design and inform the technical~     development team to further refine the game experience in preparation for a larger randomized~     controlled trial evaluating the effectiveness of Sinasprite.~   "
46687|NCT02955771|"~     This is a multi-center, randomized, controlled, open-label, phase IIa clinical study.The~     study will observe the efficacy and safety of Deuteporfin photodynamic therapy in addition to~     stenting compared to stenting alone in patients with unresectable advanced Perihilar~     Cholangiocarcinoma.~   "
46688|NCT02955758|"~     This phase II trial studies how well pembrolizumab works in treating patients with~     non-squamous non-small cell lung cancer which has spread to other places in the body.~     Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells~     to grow and spread.~   "
46689|NCT02955745|"~     Current iodine requirements defined for pregnancy and lactation are rough factorial estimates~     extrapolated from older studies in adults that used radioactive iodine tracers. To ensure~     optimal thyroid function in these vulnerable groups, a tracer method that could be safely~     used to accurately define iodine requirements would be valuable. Iodine-129 (129I), a~     long-lived semi-stable isotope with no health risks, could be used as a tracer, but the~     analytic challenges are formidable. However, we have developed an ICP-MS method to measure~     pp-billion (10-9) to pp-trillion (10-12) quantities of 129I in biological samples. In this~     project we will perform a study in which iodine-replete adult subjects will consume an oral~     dose of 129I. We will quantify 129I kinetic patterns in plasma, urine and stools after the~     oral dose, and use these data to derive tracer absorption, retention and excretion rates.~     This trial will allow us to define optimized procedures for the routine application of this~     method to assess iodine metabolism in humans. The use of 129I may prove to be a breakthrough~     technique to safely assess iodine metabolism and requirements in pregnant/lactating women in~     order to ensure healthy thyroid function in these age groups.~   "
46690|NCT02955732|"~     We aim to characterize the bioavailability and pharmacokinetics of dexmedetomidine after~     intranasal dosing employing pharmacometrics methods in otherwise healthy 1 month to 11 years~     of age children scheduled for minor surgery or other procedures requiring sedation or~     anesthesia.~   "
46691|NCT02955719|"~     Age remains the single most significant risk factor for developing dementia, particularly~     Alzheimer's dementia (AD). Given the rate at which Canada's population is aging, the quest to~     determine modifiable risk factors, whether by prevention, earlier detection, or an ability to~     slow the rate of decline, is a key priority in health care. Primary care is likely to play a~     pivotal role in this initiative. Collaborative mental health care between primary care~     providers and mental health clinicians has been demonstrated to be effective at the patient~     and system levels. Thus, the overall goal of this project is to assess impact and feasibility~     of implementing a collaborative care evidence-based Integrated Care Pathway (ICP) in~     addressing three potentially reversible risk factors at high risk for developing AD: anxiety,~     depression, or mild cognitive impairment (MCI).~   "
46704|NCT02955550|"~     This study will find the highest acceptable treatment dose and timing of infusion of cord~     blood, culture expanded natural killer (NK) cells, a kind of immune cell, in patients with~     multiple myeloma.~      The NK cells will be given at varying days post autologous stem cell transplant. rhIL-2 is~     administered after treatment to help the NK cells expand in the body. The safety of this~     treatment will be studied and researchers want to learn if NK cells will help in treating~     multiple myeloma.~   "
46705|NCT02955537|"~     This study seeks to evaluate a multicomponent mobile intervention to change multiple~     hypertension-related health behaviors in African Americans with uncontrolled hypertension.~     Half of the participants will receive a mobile intervention designed to improve physical~     activity, sodium intake, and medication adherence. The other half will receive usual care.~   "
46706|NCT02955524|"~     The objective of this study is to use local topical anesthesia to numb the sensory input,~     captured by branches of the Trigeminal nerve found on the skin in and around the eye, to~     decrease a hemodynamic reflex seen during placement of a catheter for intra-arterial~     chemotherapy (IAC) for eye tumors in children. This Trigeminal-cardiac reflex brings about~     hemodynamic instability during general anesthesia.~      Normally, one could block this sensorial input with ophthalmic peribulbar placement of local~     anesthetics, but these eyes have malignant growth and invasive procedures may cause more~     harm. The investigators are aiming to numb the sensory branches of the trigeminal nerve~     non-invasively and observe for any decrease in these events.~   "
46707|NCT02955511|"~     Hypothesis The use of Macintosh blade sized #3.5 (vs Macintosh size #3) would reduce the time~     required to achieve successful tracheal intubation and improve the glottic view.~      Study objective The purpose of this research study is to compare 3 different laryngoscope~     blades (sizes: 3.5, 3.5 and 3) and see if the blades size 3.5 will reduce the time required~     to achieve successful tracheal intubation and improve the physician's view of the glottis~     compared to the standard direct laryngoscope using the blade size 3, in patients undergoing~     lumbar surgery.~      Primary end point: time to achieve successful tracheal intubation.~      Secondary end points: glottic view at intubation, number of intubation attempts and~     effectiveness of the integrated suction in the Inscope Direct Laryngoscope.~   "
46708|NCT02955498|"~     The purpose of this study is to assess the pharmacokinetic characteristics of olmesartan and~     S-amlodipine after single oral administration of Sevikar tab. 10/40mg, a combination~     formulation of olmesartan and amlodipine as reference drug and Lodivikar tab. 5/40mg, a~     combination formulation of olmesartan and S-amlodipine as test drug in healthy male adults.~     Additionally the safety and tolerability of two drugs will be evaluated.~   "
46709|NCT02955485|"~     Chronic ankle instability is a common problem that may follow an ankle sprain. Until a~     patient has developed chronic ankle instability they are ineligible for surgical treatment~     although early surgical treatment yields better results compared to surgical treatment of~     subjects that have experienced recurrent ankle sprains. However, treating all patients with~     an ankle sprain surgically is not an option due to the high amount of unnecessary invasive~     interventions.~      The objective of this study is to identify which patients will develop chronic ankle~     instability and to develop a model to predict which patients should receive early surgical~     treatment.~      In this prospective observational cohort all patients (older than 18 years) that report at~     the emergency department of the participating hospitals after a lateral ankle sprain, of whom~     an x-ray is made after positive Ottawa Ankle Rules and on which there is no visible fracture~     or other pathology.~      The main study parameter is a significant difference in patient characteristics, foot and~     ankle configuration and joint pathology between patients who develop chronic ankle~     instability and patients who do not experience recurrent ankle sprains and restriction during~     daily live after an initial sprain.~   "
46710|NCT02955472|"~     The purpose of this clinical trial is to (1) evaluate the bioequivalence(BE) of GLA5PR~     GLARS-NF3 tablet 150mg administered regular diet relative to GLA5PR GLARS-NF1 tablet 150mg~     administered regular diet and (2) determine the safety and tolerability of a single dose of~     GLA5PR GLARS-NF3 tablet 150mg administered regular diet and GLA5PR GLARS-NF1 tablet 150mg~     administered regular diet.~   "
46711|NCT02955459|"~     This is a 2-part, first-in-human dose-ranging study to evaluate the safety, tolerability and~     pharmacokinetics of escalating doses of VNRX-5133 administered via intravenous (IV) infusion~     in healthy subjects. In part 1, subjects will receive a single dose of VNRX-5133; in part 2~     subjects will receive VNRX-5133 for 7 days.~   "
46712|NCT02955446|"~     This is a single-center, open label, non randomized, compassionate use protocol in patients~     with advanced solid tumor malignancies who were previously enrolled in the phase I study~     (NCT00878189) of this agent.~   "
46713|NCT02955433|"~     This study is a prospective clinical trial designed to primarily test the impact of~     rideshare-based transportation services from a digital transportation network, Lyft, on~     reducing primary care clinic missed appointments--a composite outcome of no-shows and same~     day cancellations--for Medicaid patients. The study population consists of West Philadelphia~     residents who are established patients at two of the Penn Medicine Primary Care Practices~     within the University of Pennsylvania Health System. The study subjects are allocated into~     the intervention or control arm using a pseudorandomization approach - those receiving an~     appointment reminder on an even calendar day are in the intervention arm and odd calendar day~     calls are in the control arm.~      Secondary outcomes include the time of arrival to the clinics relative to actual appointment~     time (both arms), prospective utilization of acute care settings (both arms), prospective~     utilization of primary care (both arms), and description of programmatic metrics in the~     intervention arm (travel time, misuse, and costs). The investigators will assess the patient~     experience after each ride using a telephone-based survey and in-depth interviews. All adults~     with established primary care at the Penn Medicine Clinics, who have Medicaid, and do not~     require wheelchair accessible rides will be eligible for the rideshare service. The~     investigators hypothesize that individuals offered a rideshare-based transportation service~     will have a decreased proportion of missed appointments and same day cancellations as those~     not offered the service.~   "
46727|NCT02955251|"~     This is an open-label, Phase I, dose-escalation study to determine the recommended Phase 2~     dose (RPTD), maximum tolerated dose (MTD), and evaluate the safety and pharmacokinetic (PK)~     profile of ABBV-428 when administered as monotherapy or in combination with nivolumab in~     participants with advanced solid tumors.~   "
46714|NCT02955420|"~     Berlin Cures develops BC 007 to treat patients suffering from diseases (chronic heart~     failure, pulmonary hypertension, chronic fatigue syndrome etc.) which are associated with~     functional autoantibodies (AAB) directed against G-protein coupled receptors (GPCR).~      The first part of the study (part A) is designed to evaluate the safety and tolerability of~     ascending doses of BC 007. The study part is blinded and placebo controlled in order to~     better discriminate possible safety signals. The assessment of safety and tolerability in an~     elderly cohort is a bridge to dosing elderly GPCR AAB positive subjects in part B. The~     subjects in part A are confirmed to be GPCR AAB negative.~      The objective of the second part of the study (part B) is to evaluate the efficacy of BC 007~     in neutralizing AAB against GPCR shortly after dosing compared to baseline and to find the~     optimal dose for the neutralization of the AAB in all individuals. This dose shall be taken~     to progress into a Phase II/III trial with beta1-adrenergic receptor-AAB positive patients~     suffering from chronic heart failure.~   "
46715|NCT02955407|"~     Patients with inflammatory back pain were shown to differ from healthy controls in genotype~     of the Angiotensin-converting enzyme (ACE), which regulates vasoconstriction/-dilatation. The~     aim of this study is to investigate whether genetic reduction of muscle perfusion might be a~     pathophysiological pathway of how genes influence chronic non-specific low back pain (LBP).~   "
46716|NCT02955394|"~     This is a randomized two arm phase II study to further evaluate the efficacy of fulvestrant~     plus enza compared to single agent fulvestrant in postmenopausal women with locally advanced~     AR+/ER+/Her2- BC who will have local surgery after ~4 months on treatment.~   "
46717|NCT02955381|"~     Randomized, double-blind, placebo-controlled, research pilot study. 30 subjects aged 22-55~     years old of all skin types will be asked to sign an informed consent form prior to any study~     procedures. Subjects must have at least 1 but up to 3 acne scars ≥3 mm or ≤ 10 mm located on~     the cheeks or forehead. Subjects will receive one treatment (Restylane® Silk or Placebo) in~     each scar at day 0, and Month 1 (2 total treatments per scar during the study). Subjects will~     be asked to come to 10 visits: Screening visit (up to 35 days prior to Baseline), Baseline~     (Day 0), Day 7, Day 14, Month 1, Month 2, Month 3, Month 4, Month 5, and Month 6 (study exit~     visit). The treatment area will be evaluated at each visit by the unblinded investigator~     regarding erythema, bruising, inflammation, itching, stinging/burning, brightness, fullness,~     smoothness, and clarity. Safety and adverse events will be captured at each visit only by the~     unblinded investigator.~   "
46718|NCT02955368|"~     The purpose of this study is to determine superiority of DP-R212 comparing to each~     monotherapy in patient with hypertension and primary hypercholesterolemia.~   "
46719|NCT02955355|"~     The purpose of this study is to assess the long-term safety, tolerability, and immunogenicity~     of the subcutaneous (SC) treatment with Immune Globulin Subcutaneous (IGSC) facilitated with~     recombinant human hyaluronidase (rHuPH20) (HYQVIA/HyQvia) in participants with chronic~     inflammatory demyelinating polyradiculoneuropathy (CIDP) who have completed Baxalta Clinical~     Study Protocol 161403 Epoch 1 or Clinical Study Protocol 161601 without CIDP worsening.~   "
46720|NCT02955342|"~     To validate the German version of the Young Spine Questionnaire (G-YSQ) and to study back and~     neck pain in adolescents between 10 and 16 years during one year by means of G-YSQ.~   "
46721|NCT02955329|"~     This study aims to understand THC pharmacology and the safety of cannabis vaping, including~     the pharmacology and safety of co-administration of nicotine and THC. The study is designed~     as a within-subjects single-blinded crossover study. Fourteen smokers of tobacco cigarettes~     and cannabis will switch between three conditions, namely: (a) vaping cannabis leaf, (b)~     vaping tobacco containing nicotine and (c) vaping a combination of cannabis leaf and tobacco~     containing nicotine. All participants will vape each product with the PAX loose-leaf~     vaporizer. The study will be conducted during three outpatient visits separated by at least~     48 hours. The order of treatment (cannabis leaf, tobacco with nicotine, cannabis leaf &~     tobacco with nicotine) will be counterbalanced between subjects. Subjects will be blinded to~     the content of the vaporizer on the study day but will be told during screening that they~     will vape cannabis alone, tobacco alone, and cannabis plus tobacco with nicotine.~   "
46722|NCT02955316|"~     The primary objective of this study is to estimate the overall prevalence of IBS medically~     diagnosed and diagnosed using Rome III or IV criteria in GI adult outpatients in China.~   "
46723|NCT02955303|"~     This study assess the feasibility of novel cognitive intervention utilizing tablet apps (TECH~     protocol: Tablet Enhancement of Cognition and Health) in terms of relevance, adherence,~     suitable challenges, training time etc. for healthy older adults. Sixty two older adults with~     normal cognition will be randomly allocated to the TECH protocol (experimental group) or the~     control group (no treatment). Assessments will be administered pre and post the 6-week TECH~     protocol by assessors blind to group allocation.~   "
46724|NCT02955290|"~     This partially randomized phase I/II trial studies the best dose and side effects of~     recombinant human EGF-rP64K/montanide ISA 51 vaccine (CIMAvax) and nivolumab and to see how~     well they work in treating patients with stage III-IV non-small cell lung cancer. Vaccine~     therapy, such as CIMAvax vaccine may help slow down and stop tumor growth. Monoclonal~     antibodies, such as nivolumab, may block a protein needed by tumor cells to grow and spread.~     Giving CIMAvax vaccine together with nivolumab may work better in treating patients with~     stage IIIB-IV non-small cell lung cancer.~   "
46725|NCT02955277|"~     This study assess the effectiveness of novel cognitive intervention utilizing tablet apps~     (TECH protocol: Tablet Enhancement of Cognition and Health) to improve cognitive abilities,~     daily function and health-related quality of life of older adults with MCI. Forty six older~     adults with MCI will be randomly allocated to the TECH protocol (experimental group) or~     standard care (control group). Assessments will be administered pre and post the 6-week TECH~     protocol and at 6-month follow-up by assessors blind to group allocation.~   "
46726|NCT02955264|"~     The goal of this study is to better characterize the metabolic alterations and sugar~     structure alterations (glycosylation abnormalities) in patients diagnosed with Congenital~     Disorders of Glycosylation. The investigators aim to assess the safety and tolerability of~     oral galactose treatment in a small pilot group of Congenital Disorders of Glycosylation~     patients. The investigators will also determine the relationship between simple milk sugar~     intake (galactose dose) in the diet and the blood and urine markers of protein glycosylation~     abnormalities.~   "
46728|NCT02955238|"~     The Latino population in the United States is increasing in size; is diverse in culture,~     backgrounds and countries of origin; is experiencing unique influences from social and~     behavioral acculturation to the U.S.; is reported nationally to have lower rates of heart~     disease; is reported to have increased prevalence of diabetes and asthma; and is generally~     poorer and less educated (NHLBI working Group, 2003). They represent an important target~     population for disparities research. In particular Latinos accessing care in Community Health~     Centers in the United States represent an ideal population for conducting disparities~     research because lack of access to care is minimized through various governmental health~     insurance support mechanisms. This study will build on existing relationships to conduct the~     proposed study, using expertise in epidemiologic, behavioral and genetic research in an~     effort to promote a coordinated, comprehensive, interdisciplinary and focused research effort~     to improve the care being delivered to indigent Latinos at-risk for and with CVD.~   "
46729|NCT02955225|"~     The purpose of this study is to determine whether use of a pressure-detecting shoe improve~     can enhance favorable loading conditions at the knee.~   "
46730|NCT02955212|"~     This is a Phase 3 multicenter study that includes two periods. Period 1 is a 12-week,~     randomized, double-blind, parallel-group, placebo-controlled period designed to compare the~     safety and efficacy of upadacitinib versus placebo for the treatment of signs and symptoms of~     participants with moderately to severely active RA who are on a stable dose of csDMARDs and~     have an inadequate response to csDMARDs. Period 2 is an open label 52 week extension period~     to evaluate the long-term safety, tolerability, and efficacy of upadacitinib in participants~     with RA who have completed Period 1.~   "
46731|NCT02955199|"~     This is a Stage III community-based randomized clinical efficacy trial testing Mothering from~     the Inside Out (MIO), the first evidence-based parenting intervention designed to be~     delivered by addiction counselors in addiction treatment settings where parents of young~     children are enrolled in treatment.~   "
46732|NCT02955186|"~     The purpose of this study is to evaluate the effects of the study medication,~     saracatinib/AZD0530 (placebo or 125 mg/day) on alcohol drinking behavior in a laboratory~     setting in which participants are given an initial drink of alcohol followed by the choice to~     drink up to 12 more drinks over a three-hour period. The investigators hypothesize that~     saracatinib will reduce craving and number of drinks consumed prior to and after exposure to~     the initial drink of alcohol and during the three hour drinking period.~   "
46733|NCT02955173|"~     The primary purpose of this study is to compare both short-term and long-term treatment~     effect of laparoscopic vs. open approach on progressive gastric and rectal cancer, based on~     circulating tumor cell (CTC) test results as well as disease-free survivals, and figure out~     principles of laparoscopic approach for progressive gastric and rectal cancer. Secondary~     purpose is to establish an evaluation system for laparoscopic surgery for progressive gastric~     and rectal cancer treatment using CTC as a biomarker.~   "
46734|NCT02955160|"~     This is a Phase 1 first-in-human, randomized, controlled, observer-blinded study with a 2-arm~     parallel design. Healthy adults aged 18 to 49 years of age with no history of pneumococcal~     vaccination will be randomized equally to receive either a single intramuscular dose of~     multivalent pneumococcal conjugate vaccine or a licensed tetanus, diphtheria, acellular~     pertussis combination vaccine (Tdap) (control group).~   "
46735|NCT02955147|"~     The purpose of this study is to determine whether ustekinumab is effective in the treatment~     of Giant Cell Arteritis (GCA)~   "
46736|NCT02955134|"~     The purpose of this study is to evaluate long-term efficacy of Chinese medicine treatment for~     chronic atrophic gastritis. It is a multi-center, randomized, placebo-controlled trial.~   "
46737|NCT02955121|"~     Randomized controlled study to examine physician use of pharmacogenetic information in~     patients receiving antiplatelet medication after percutaneous coronary intervention (PCI).~   "
46738|NCT02955108|"~     The objective of this study is to look at the effects of distractive auditory stimuli (DAS)~     on reducing dyspnea intensity and related anxiety and increasing exercise tolerance.~     Investigators hope that compared to a no-music control condition, that under a music~     condition participants with COPD will (a) demonstrate increased self-paced walk distance and~     enjoyment; (b) have less dyspnea intensity, (c) experience less dyspnea anxiety; (d) have~     less fatigue and state anxiety; and (e) higher maximum heart rate. The upbeat music with a~     tempo of 90 - 100 bpm (an average-to-moderate walking tempo) is expected to have distractive~     and performance enhancing effects in order to increase tolerance to dyspnea and exercise. The~     long-term goal of this study is to increase physical activity in adults with COPD and RLD by~     promoting dyspnea and fatigue management through use of distractive auditory stimuli in the~     form of music.~   "
46739|NCT02955095|"~     The purpose of the usability and pilot testing for the project Developing a Bi-national~     Buddy Intervention for Smoking Cessation and Cultural Education is to better understand how~     users interact with the smoking cessation app, and to improve the product based on the~     results. In pilot testing the smoking cessation app the investigators will examine the~     feasibility of our approach. The usability testing portion of the study is intended primarily~     to improve on the design of the smoking cessation app, and will: gather quantitative data on~     participant's performance, identify usability problems, and determine user satisfaction with~     the app. The pilot testing portion of the study will evaluate the feasibility, time, cost and~     statistical variability in an attempt to predict an appropriate sample size and improve upon~     the study design prior to performance of a full-scale research study.~      Objective 1:To collect quantitative data on participant's performance while using the app for~     smoking cessation.~      Objective 2:To identify problems with usability of the smoking cessation buddy app.~      Objective 3:To assess user satisfaction with the smoking cessation buddy app. Objective 4:To~     improve upon the design of the smoking cessation buddy app Objective 5:To assess the~     feasibility, time, cost, and statistical variability for a full-scale implementation of this~     study with the intervention group.~   "
46797|NCT02954341|"~     The purpose of this Post Approval Study (PAS) is to evaluate the use of the CardioMEMS HF~     System in patients with Class III Heart Failure in a commercial setting.~   "
47110|NCT02950259|"~     The goal of this study is assess the safety and tolerability of the IRX-2 regimen in patients~     with early stage breast cancer (ESBC) and to estimate the pathologic complete response rate~     to neoadjuvant anthracycline-based and non-platinum containing chemotherapy in patients with~     triple-negative breast cancer who have received the IRX-2 Regimen before chemotherapy.~   "
46740|NCT02955082|"~     Prostate cancer (PrCa) is one of the commonest cancer in men in the Western world, with over~     40,000 new cases diagnosed each year in the United Kingdom (UK). Research studies have~     identified several genetic changes that are thought to increase the risk of developing~     prostate cancer. Some of these genetic changes occur in deoxyribonucleic acid (DNA) repair~     genes. The BARCODE 2 study is formed of two parts that aim to investigate how having genetic~     changes in DNA repair genes can affect response to treatment. In part 1 of the study, the~     investigators will invite men with metastatic castration resistant prostate cancer (mCRPC)~     who have not had genetic testing before to join the study by initially undergoing genetic~     screening within the study. If a pathogenic mutation is confirmed in one of these genes,~     patients will be given the option to proceed to part 2 of the study. In part 2 of the study,~     men with mCRPC who are known to be carriers of a mutation in DNA repair gene(s) will be~     assessed for eligibility for treatment on the study. The aim of the study will be to~     determine how patients with mCRPC and a germline mutation in a DNA repair gene(s) respond to~     platinum chemotherapy. This study will help researchers to investigate the platinum~     sensitivity of prostate tumours that have developed due to a germline mutation in a DNA~     repair gene. This study will provide data to use in a larger clinical trial of platinum~     chemotherapy based on patients' germline genetic signature and/or tumour genetic profile.~   "
46741|NCT02955069|"~     This is a study to investigate the efficacy and safety of PDR001 in patients with advanced or~     metastatic, well-differentiated, non-functional neuroendocrine tumors of pancreatic,~     gastrointestinal (GI), or thoracic origin or poorly-differentiated gastroenteropancreatic~     neuroendocrine carcinoma (GEP-NEC) that have progressed on prior treatment.~   "
46742|NCT02955056|"~     This is a single site feasibility trial to test whether daily administration of Teriparatide,~     in participants with Weber type B ankle fractures that are being conservatively managed, is~     superior to the standard care treatment with regard to the rate of healing.~   "
46743|NCT02955043|"~     The goal of this project is to conduct a pilot randomized clinical trial (RCT) to evaluate~     the feasibility of a brief, behavioral intervention to improve recovery following~     hematopoietic stem cell transplantation (HSCT). Cancer patients who were treated with HSCT~     will learn behavioral techniques to improve sleep and increase daytime activity with the goal~     of alleviating insomnia, fatigue, and depression. If the intervention demonstrates evidence~     of feasibility and acceptability, a future study will test the effects in a larger trial,~     with the long-term goal of improving the care and quality of life of cancer survivors~     recovering from HSCT.~   "
46744|NCT02955030|"~     The purpose of this study is to evaluate the safety and immunogenicity of a sublingual~     administration of NSV0001 in healthy male volunteers.~   "
46745|NCT02955017|"~     The purpose of this study is to evaluate the efficacy of a distance follow-up on body mass~     index decrease at 15 months compared to traditional management in obese adolescents.~   "
46746|NCT02955004|"~     The purpose of this study is to study the effects of transthoracic electrical cardioversion~     for restoration of sinus rhythm in patients who present with recent onset atrial~     fibrillation, with regard to new silent cerebral thrombo-embolic lesions and cognitive~     function, as well as electrical and functional/structural reverse remodelling, and its~     effects on inflammatory changes / specific cardiac biomarkers, vasoactive peptides,~     coagulation activity, and active fibrinolysis.~   "
46747|NCT02954991|"~     The study will evaluate the clinical activity of nivolumab in combination with 3 separate~     investigational agents, glesatinib, sitravatinib, or mocetinostat.~   "
46748|NCT02954978|"~     Parkinson's disease (PD) is the second most common neurodegenerative disorder causing motor~     and non-motor symptoms. PD is characterized by death of dopaminergic (DA) neurons in the~     substantia nigra (SN) pars compacta and formation of inclusions known as Lewy bodies (LBs)~     that primarily contain aggregated alpha-Synuclein. Nilotinib (Tasigna®, AMN107, Novartis,~     Switzerland) is approved by U.S. Food and Drug Administration (FDA) and is well tolerated for~     CML treatment at oral doses of 600-800mg daily. Nilotinib penetrates the brain and promotes~     autophagic degradation of alpha-Synuclein and p-Tau, leading to survival of DA neurons and~     improvement of motor function in PD models. For these studies, Nilotinib (1-10mg/kg daily)~     was used at significantly less than the clinically approved dose (up to 1200mg daily) in CML.~   "
46749|NCT02954965|"~     The purpose of the current study is to test the efficacy of two brief, behavioral~     interventions intended to improve burnout among doctoral-level graduate students (n = 102).~     Specifically, individuals will be randomly assigned to one of three intervention conditions:~     1) Reward: a brief intervention to help participants increase engagement in healthy and~     rewarding values-driven behaviors, 2) Approach: a brief intervention to help participants~     identify and decrease emotion-driven avoidance of important goals, or 3) Control: a control~     condition that involves monitoring only. Multilevel modeling will be used to assess changes~     in burnout, mood, and stress, following the interventions, controlling for participants'~     individual baseline levels of these variables.~   "
46750|NCT02954952|"~     This is a prospective, single-center, cohort study in patients undergoing surgical procedures~     to collect data using Masimo SedLine EEG device in order to evaluate a newer version of PSI~     measurement against an older version of PSI measurement.~   "
46751|NCT02954939|"~     This study investigated the effect of mycophenolate mofetil and cyclosphosphamide on~     lymphocyte subsets in patients with proliferative lupus nephritis. Patients with~     biopsy-proven Class III/IV+/-V LN were randomized to received: 1) prednisolone (0.8mg/kg/day)~     plus CTX (1.5-2mg/kg/d) for 6 months) followed by Azathioprine (AZA) (1-1.5mg/kg/d)~     maintenance; OR 2) prednisolone (0.8mg/kg/d) plus MMF (1g bd) for 6 months, followed by MMF~     (tapered according to clinical status) as maintenance. The lymphocyte subsets and serum~     cytokine profiles will be measured at 4-, 12-, and 24-, 36- and 48 weeks after induction~     treatment. The lymphocyte subsets and serum cytokine profiles will be compared between the~     two treatment regimens, and also correlated with subsequent risk of relapse.~   "
46752|NCT02954926|"~     Majority of healthcare authorities believe that due to the methodological weakness and small~     number of patients in conducted therapeutic trials, the evidences are insufficient to support~     the efficacy of intravenous immunoglobulin (IVIG) in prevention of preterm neonatal sepsis.~     The objective of this research is to determine the effect of intravenous immunoglobulin in~     prevention of preterm neonatal sepsis.~   "
46753|NCT02954913|"~     Synchronous colorectal cancer with liver metastases, defined as the diagnosis of a primary~     colorectal tumour and liver metastases within 12 months, is a common problem faced by~     colorectal and hepatobiliary surgeons.(Adam) The traditional approach is to perform staged~     resections unless the liver resection required is limited (i.e. small wedges of peripheral~     lesions). The downside of performing staged vs. simultaneous resections is that patients must~     undergo two major operations instead of one, which limits a patient's ability to return to~     their pre-surgical state of health in a timely fashion, increasing health care costs (Ejaz)~     and delaying the start of adjuvant chemotherapy. The disadvantages of a simultaneous approach~     include longer operating room times potentially increasing the major postoperative~     complication rate including blood transfusions, surgical site infections, anastomotic leaks~     and post-hepatectomy liver failure. Recent data from tertiary cancer centres suggest that~     simultaneous resection of the colon and rectum along with liver resection of any magnitude is~     feasible and safe.(Silberhumer) Although encouraging, this data comes from specific patients~     from a highly selected institution, results that are perhaps not generalizable.~      This proposal is a feasibility study consisting of a pilot single arm prospective study at~     two different large-volume Hepatobiliary Centres of patients with synchronous colorectal~     cancer with liver metastases undergoing simultaneous resection of the colon or rectum and~     liver to evaluate their complication rates (including the calculation of the comprehensive~     complication index), quality of life, cost evaluation, and proportion of eligible patients~     recruited over a 12-month period. The results of this pilot study will provide us with the~     information necessary to build a large multicentre randomized controlled trial comparing~     staged vs. simultaneous resection for synchronous colorectal cancer liver metastases.~   "
46754|NCT02954900|"~     The purpose of this pilot study is to evaluate a decision support website (RealRisks)~     designed to inform patients about breast cancer chemoprevention. It is coupled with a~     physician-centered (BNAV) decision support website as part of clinical workflow in the~     primary care setting. The investigator hypothesizes that improving accuracy of breast cancer~     risk perception and understanding of the risks/benefits of chemoprevention will enhance~     informed decision-making and uptake of breast cancer prevention strategies in the primary~     care setting.~   "
46755|NCT02954887|"~     This trial consists of 3 parts: a pilot safety phase, a pivotal randomized controlled phase,~     and an open-label extension phase. The open-label extension phase only will be described in~     this record. All participants will receive GWP42003-P.~   "
46756|NCT02954874|"~     This randomized phase III trial studies how well pembrolizumab works in treating~     triple-negative breast cancer. Monoclonal antibodies, such as pembrolizumab, may interfere~     with the ability of tumor cells to grow and spread.~   "
46757|NCT02954861|"~     'Post perfusion syndrome' was a term historically associated to cardiac surgery in view of~     the transient neuro-cognitive deficits attributed to cardio pulmonary bypass pump. During~     their recovery period, a significant number of patients experience delirium, a clinical~     syndrome of acute onset and fluctuant course.Though these deficits are often known to be~     transient without any permanent physical or neurological impairment, the experience can still~     psycho-socially affect these patients for a longer length of time even after discharge. The~     presence of delirium puts excessive, undesired strain on the patient, their families, health~     care providers and hospital resources.~      PTSS is an anxiety disorder caused by very stressful, frightening or distressing events. It~     is known to either develop immediately after the disturbing event or weeks and months later.~     The actual symptoms can be varied but are categorized in three sections: i.e.:~     re-experiencing, avoidance and emotional numbing and hyperarousal (feeling 'on edge').~      A problem that has such an impact on any patient is worth investigating and understood~     better. Being in such a unique professional position, as a Clinical nurse practitioner, the~     investigator is ideally placed to conduct this study. In this study, the researcher will be~     focusing on the pre-operative risk factors in developing delirium, actual incidence of~     delirium and follow the patients post operatively to evaluate the after effects of delirium~     in the form of PTSS.~   "
46758|NCT02954848|"~     The purpose of this study is to evaluate the efficacy and safety of oral TAK-438 10 mg~     once-daily in the treatment of non-erosive gastroesophageal reflux disease~   "
46759|NCT02954835|"~     The purpose of this study is to compare wound infection rates between negative pressure~     therapy (Prevena) and the traditional sterile dry dressing among patients undergoing vascular~     surgery involving groin incisions.~   "
46760|NCT02954822|"~     A randomized, open-label, multiple dosing, three treatment, three period, two sequence~     clinical trial to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of~     evogliptin 5 mg and glimepiride 4 mg after oral administration in healthy male subjects~   "
46761|NCT02954809|"~     The purpose of this study is to determine the effects of morning bright light therapy on~     fatigue, sleep disturbances, and circadian activity rhythms in lung cancer survivors.~   "
46762|NCT02954796|"~     This study tests the safety of a drug called SGN-CD352A, to find out what its side effects~     are. SGN-CD352A will be given every 4 weeks to a small group of patients with multiple~     myeloma.~   "
46763|NCT02954783|"~     Background and purpose: The purpose of this study is to investigate the effect of exercise on~     intratumoral natural killer (NK)-cell variability in patients with localized prostate cancer~     undergoing radical prostatectomy.~      The primary hypothesis is that exercise induces epinephrine-mediated intratumoral natural~     killer (NK)-cell infiltration in patients with localized prostate cancer, and that the~     infiltration is greater in patients performing High Intensity Interval Training compared to~     moderate intensity training.~      Currently there is a lack of randomized controlled trials examining different types of~     exercise in patients with localized prostate cancer. Moreover there is a need for studies~     including biological measurements to allow a full assessment of the effect of exercise on~     diverse biomarkers and mechanistic pathways, which may influence cancer survival.~      Subjects: Patients with histologically verified prostate adenocarcinoma scheduled for radical~     prostatectomy at Urologic Department, Rigshospitalet, Copenhagen, Denmark.~      Methods: In this randomized controlled pilot study 30 patients with localized prostate cancer~     undergoing radical prostatectomy will be included and randomized to either High Intensity~     Interval Training (HIIT) exercise intervention, Moderate-Intensity Aerobic Exercise and~     Resistance Training (MI-AT+RT) intervention (standard recommendations) or observational~     control receiving usual care for a total period of 8 weeks.~      All patients will undergo assessments at inclusion (baseline) and after 8 weeks (5-7 days~     prior to surgery,) respectively.~      Assessments include: anthropometrics; blood pressure; resting hearth rate; cardiorespiratory~     fitness by cardiopulmonary exercise test (VO2 peak.); body composition by DXA scan; quality~     of life by self-report questionnaires; oral glucose tolerance test; fasting blood sample~     measuring cholesterol, triglycerides, insulin, c-peptide, HbA1c, glucose, hormones and~     inflammatory markers.~      Also, the investigators will collect blood samples before, during and after an acute exercise~     bout in order to explore the acute systemic changes in exercise-regulated biomarkers.~      Biological tissue from tumor (primary prostate biopsies) will be retrieved from the~     respective local pathological departments and from the perioperative prostate specimen and~     sent to protocol analyses.~   "
46764|NCT02954770|"~     This is a one year follow up survey study after a Fitbit® challenge study to determine if~     wearing a Fitbit® motivates residents to increase their physical activity. This study seeks~     to determine if residents continue to use the Fitbit® after one year.~   "
46808|NCT02954198|"~     With the availability of well-studied once-daily formulations of tacrolimus, the ability to~     achieve a true once-daily immunosuppressant regimen along with everolimus and steroids may~     finally be achievable and have the potential to optimize immunosuppression safety and~     efficacy in kidney transplantation.~   "
46765|NCT02954757|"~     Uterine adenomyosis is a common uterine benign condition. They can cause abnormal menstrual~     bleeding, and menstrual pain. Although surgical intervention is the definitive treatment,~     some women prefer to have their uterus preserved. High-intensity focused ultrasound (HIFU)~     therapy is receiving increasing interest in the management of uterine adenomyosis by inducing~     focal thermocoagulation of the fibroids. Results obtained by various research groups have~     shown that HIFU treatment is safe, effective and is highly acceptable to patients. The main~     objective of this study is to evaluate the therapeutic efficacy of HIFU in the treatment of~     uterine adenomyosis.~      In this proposed study, 10 patients who have symptomatic uterine adenomyosis who meet the~     study inclusion criteria will be invited to participate in the study which involves the use~     of HIFU in the management of the adenomyosis. Background information of the patients such as~     age, body mass index, hormonal (pre- or postmenopausal) status and the presence of chronic~     medical disease will be collected. Subjects will also be asked to complete an eight-item~     section of a Uterine Fibroid Symptom and Quality Of Life Questionnaire (UFS-QOL) and~     menstrual pain score which evaluate the effect of the adenomyosis on the quality of life of~     women.~   "
46766|NCT02954744|"~     Uterine fibroids are common uterine benign neoplasm. They can cause abnormal menstrual~     bleeding, pelvic discomfort and urinary frequency. Although surgical intervention is the~     definitive treatment, some women prefer to have their uterus preserved. High-intensity~     focused ultrasound (HIFU) therapy is receiving increasing interest in the management of~     uterine fibroids by inducing focal thermocoagulation of the fibroids. Results obtained by~     various research groups have shown that HIFU treatment is safe, effective and is highly~     acceptable to patients. The main objective of this study is to evaluate the therapeutic~     efficacy of HIFU in the treatment of uterine fibroids.~      In this proposed study, 20 patients who have symptomatic uterine fibroids who meet the study~     inclusion criteria will be invited to participate in the study which involves the use of HIFU~     in the management of the fibroid. Background information of the patients such as age, body~     mass index, hormonal (pre- or postmenopausal) status and the presence of chronic medical~     disease will be collected. Subjects will also be asked to complete an eight-item section of a~     Uterine Fibroid Symptom and Quality Of Life Questionnaire (UFS-QOL) which evaluate the effect~     of the fibroid on the quality of life of women.~   "
46767|NCT02954731|"~     Transdiagnostic Cognitive Behavior Therapy (CBT) delivered in the individual format, have~     been proven just as effective as traditional diagnosis specific CBT manuals. The~     investigators have translated and modified the The Unified Protocol for Transdiagnostic~     Treatment of Emotional Disorders (UP-CBT) to make it applicable as group therapy in Danish~     Mental Health Service and a naturalistic trial of this manual has shown promising results. As~     the use of one manual instead of several diagnosis specific manuals in regional clinics could~     simplify logistics and reduce waiting time, the investigators want to compare group UP-CBT~     with diagnosis specific group CBT.~      Method: A partial blinded, pragmatic, non-inferiority, multicentre randomized clinical trial~     (RCT). UP-CBT is compared to treatment-as-usual CT. 124 patients are included in each~     intervention arm, recruited from three Danish regional Mental Health Service Clinics.~   "
46768|NCT02954718|"~     Juvenile idiopathic arthritis (JIA) is most common chronic rheumatic disease in childhood.~     The upper extremity involvement in JIA causes muscle imbalance, joint destruction, pain,~     stiffness and limitations on daily living activities (DLA) in varying degrees. However, the~     information about prevalence of symptoms, disorders, DLA limitations, participation~     restriction and options of treatments for upper extremity involvement in JIA are limited. It~     has been reported that improvements of upper extremity functions were achieved by video-based~     games (VBG) in various disease groups. However, in the literature, no study has been found~     about effectiveness of WBG in children with arthritis. The aim of the study was to~     investigate effects of task-oriented activity training (TOAT) with VBG versus activity~     training in real life on activity performance and participation in children with arthritis.~     Participants with upper limb involvement in JIA were randomly assigned to the activity~     training in real life group (group I) and TOAT with VBG in real life group (group II). The~     actual materials and rehabilitation kits will be used for activity training in group 1, the~     DLA that expected to gain independence will be trained with VBG in group 2. Upper extremity~     muscle strength and grip, range of motion, upper limb functions, activity, participation and~     quality of life will be evaluated. The hypothesis of this study is that TOAT with VBG~     improves the activity performance and physical functions and increases the participation, via~     being stimulative and interactive in order to provide feedback and to increase interest and~     motivation.~   "
46769|NCT02954705|"~     Activation of neutrophils by ANCA (Anti-Neutrophil Cytoplasm Antibodies) and subsequent~     microvascular endothelial cell damage is the main feature of ANCA-associated vasculitis~     (AAV), a severe autoimmune disease that often targets the kidney. There is no specific~     treatment for AAV to date and 25% of patients with renal damage evolve towards end-stage~     renal disease, requiring dialysis and kidney transplantation. In addition, there is no~     reliable biological marker of the disease activity available, which makes the diagnostic,~     follow-up and treatment of patients difficult. Therefore, the identification of new~     therapeutic targets and non-invasive biomarkers constitutes a major clinical challenge to~     improve AAV patients care and to ameliorate their renal outcome.~   "
46770|NCT02954692|"~     Primary Objective:~      To assess the mean change in HbA1c (glycated haemoglobin).~      Secondary Objectives:~      To evaluate the efficacy and safety of the titration of insulin glargine U300 in terms of:~        -  Targeted HbA1c;~        -  Targeted fasting self- monitoring blood glucose (SMBG);~        -  Hypoglycemic events;~        -  Adverse events;~        -  Quality of life assessment by DTSQs (Diabetes Treatment Satisfaction Questionnaire~          status) and DTSQc (Diabetes Treatment Satisfaction Questionnaire change);~        -  Blood glucose fluctuation by using continuous glucose monitoring system (CGMS) in~          subgroup patients.~   "
46771|NCT02954679|"~     This descriptive and declarative study will help to find out consumption rates, all~     psychoactive substances taken together, among 18-25 year olds. More specifically, it will~     allow assessment of the extent of the cognitive enhancement phenomenon among students in~     France (including study of misuse of methylphenidate (MPH) and modafinil in improvement of~     cognitive performance).~   "
46842|NCT02953743|"~     The primary purpose of this study is to assess the single- and multiple-dose pharmacokinetic~     (PK) profile of lenvatinib in Chinese participants with unresectable Hepatocellular Carcinoma~     (HCC).~   "
46772|NCT02954666|"~     Different approaches to cardio-neuroablation (CNA) to treat neurally mediated syncope, sinus~     node dysfunction, and functional atrioventricular block have been published. Investigators~     have developed a more limited and specific approach of CNA, called cardio-neuromodulation~     (CardNM). This treatment is based on a tailored vagolysis of the sinoatrial node through~     partial ablation of the anterior right ganglionated plexus (ARGP); it is also based on an~     innovative anatomic strategy. The feasibility of CardNM has already been tested in our center~     in a limited first study in humans (CardNMH1), with a favorable outcome for the patients~     involved. The results of CardNMH1 have been submitted for publication. The purpose of this~     second study of CardNM in humans (CardNMH2) is to collect more procedural and clinical data~     in well-defined patient groups.~   "
46773|NCT02954653|"~     Two part, dose escalation and dose expansion study. Open label, multi center, non randomized,~     multiple dose, safety, pharmacokinetic and pharmacodynamic study of single agent PF-06747143~     in sequential dose levels of adult patients with refractory or relapsed AML in order to~     establish maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D) or maximally~     permitted dose (MPD) following by a 3 arm dose expansion with PF-06747143 in combination with~     standard of care chemotherapy in adult patients with AML.~   "
46774|NCT02954640|"~     In order to accelerate the identification of genes responsibles of PID, and to improve the~     diagnosis of PID, the research team would like to validate a rapid and targeted method of~     high-throughput sequencing, on 301 genes, known to be involved in PID.~   "
46775|NCT02954627|"~     This is a substudy to a randomised trial investigating the effect of liraglutide on body~     weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864). In~     the parent trial, patients will be subjected to an 8-week diet intervention phase including a~     low-calorie diet and dietetic counseling, after which patients will be randomised to receive~     either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on~     re-introducing regular foods and a focus on continued motivation to engage in a healthy~     lifestyle.~      This substudy aims to investigate any changes in the carotid intima media thickness (CIMT)~     assessed by ultrasound in relation to an initial 8-week weight loss intervention.~   "
46776|NCT02954614|"~     Background: Physical activity (PA) is a key component in health promotion and prevention of~     overweight. Interventions delivered in after-school programs (ASP) have the potential to~     become a means of ensuring PA among young schoolchildren. This requires a motivational~     climate, allowing for self-determination and the intrinsic values of the activity, on the~     activity's character of play. ASP staff could be trained in stimulating all children in~     physical activities in their everyday life. Physiotherapists in primary care possess~     knowledge of motor development and learning, and are important contributors to an ASP-based~     physical activity intervention.~      Aim: To develop a complex intervention that emphasizes physical activity play, and to examine~     through a cluster-randomized trial the extent to which the intervention promotes PA and~     health-related quality of life and prevents overweight in a population of young children. We~     aim to increase the knowledge and autonomy supportive skills among ASP staff members,~     enabling them to promote physical activity through play among all first graders in ASP.~      In addition to investigate if the children benefit from receiving autonomy support, we aim to~     study whether the ASP staff themselves benefit from giving autonomy support in terms of~     increased need satisfaction and autonomous motivation for work.~      The intervention: Includes training of ASP-staff members in the fundamental principles of~     self-determination theory and practical applications for motivating young children in PA~     through play. Information will be given on the benefits of a physically active lifestyle and~     the staff will be encouraged to map opportunities for PA in their local ASP and to~     incorporate strategies to increase PA through play among the children throughout the day.~      Methods/design: A complex intervention using a mixed methods approach will be developed and~     evaluated. A pilot trial will assess the potential of this approach and provide information~     necessary to perform a cluster-randomized controlled trial (RCT). The cluster-randomized~     controlled trial (RCT) will together with qualitative interviews and observations, evaluate~     the effectiveness of the intervention. Outcomes will be measured at baseline (September~     /October 2016) at the end of the intervention which lasts for 7 months (May 2017), and 1 year~     after the end of the intervention (May 2018)~   "
46777|NCT02954601|"~     This study will enroll approximately 30 adult subjects with T2DM from age 20 to 75 inclusive.~      Following a 7-10 day Screening period, eligible subjects will enter a 3-day single-blind~     placebo run-in. On Day 4, each subject will be randomized to a treatment sequence that will~     include three treatment assignments for each of three treatment Periods according to the~     randomization scheme.~   "
46778|NCT02954588|"~     A growing body of evidence demonstrates that increased adipose mass, especially visceral~     adipose tissue, contributes directly towards an increase in systemic inflammation,~     (micro-)vascular dysfunction and the burden of cardiovascular disease (CVD), insulin~     resistance and type 2 diabetes. Advanced glycation/lipoxidation endproducts (AGEs/ALEs) are a~     heterogeneous family of unavoidable by-products, which are formed by reactive metabolic~     intermediates derived from glucose and lipid oxidation. In addition to the overwhelming~     amount of data demonstrating the role of AGEs/ALEs in the development of (micro-)vascular~     dysfunction and disease, accumulation of AGEs/ALEs in the expanding adipose tissue~     contributes to the dysregulation of adipokines and the development of insulin resistance.~      The investigators want to examine, in a double-blind randomized placebo controlled parallel~     study, the physiological effect of a dietary intervention with pyridoxamine in abdominally~     obese persons.~   "
46779|NCT02954575|"~     The purpose of this study is to obtain additional data on the safety and efficacy of Wilate~     in PTPs with hemophilia A with at least 150 previous exposure days (EDs) to a FVIII~     concentrate who undergo prophylactic treatment with Wilate for 6 months and at least 50 EDs,~     thus supplementing the existing database to obtain approval of Wilate for the indication~     hemophilia A in the USA.~   "
46780|NCT02954562|"~     In this study, people will be undergoing brain scans with functional magnetic imaging (fMRI)~     while they perform an emotional regulation task that involves observing either neutral images~     or images known to induce negative emotions, with instructions either to view passively or~     attempt to reduce the negative affect associated with the images. Resting state brain scans~     (with no explicit task) will also be acquired. Heart rate variability will be measured during~     these resting state scans. While in the scanner, subjects will also listen to prerecorded~     audio scripts about life stresses for themselves and for another person with instructions to~     practice compassion for themselves or for others. In yet another task, they will respond to~     pictures known to produce positive and negative emotions and perform an attention related~     task. The scans will take place once before and at least once after undergoing sessions of~     methylenedioxymethamphetamine (MDMA) assisted psychotherapy. Brain scans will happen three~     times: an initial scan before placebo or MDMA-assisted psychotherapy, a second scan after~     either two placebo or two MDMA sessions (depending on whether the subject was in the placebo~     or MDMA group), and one final scan after the conclusion of three active MDMA sessions.~   "
46843|NCT02953730|"~     The purpose of the trail is to study the pharmacokinetics of Pegylated Recombinant Human~     Granulocyte Stimulating Factor（PEG-rhG-CSF） in Children and Adolescents~   "
46781|NCT02954549|"~     A genomics-based approach will target specific genes that may explain the response in~     biomarkers and symptoms before and after supplementation. One objective is to generate~     evidence-based recommendations for vitamin D supplementation in Soldiers who often experience~     musculoskeletal disorders and immune dysfunction impacting physical performance and military~     readiness. The investigation is designed to address these specific aims: 1) explore vitamin D~     status in 105 Service Members to determine common symptoms associated with deficiency; 2)~     examine the effect of vitamin D levels on gene expression from select genes known to~     influence metabolism, bone density, and immune function; and 3) evaluate changes in gene~     expression between groups receiving high or low supplementation, and compare to healthy~     controls. Follow-up at 15 months will evaluate circulating vitamin D.~   "
46782|NCT02954536|"~     The purpose of this study is to find out what effects, good and/or bad, pembrolizumab in~     combination with trastuzumab and chemotherapy, has on the patients' esophagogastric cancer.~   "
46783|NCT02954523|"~     This is a study for patients with advanced non-small cell lung cancer with changes to their~     cancer cells called EGFR mutations. Mutated EGFR is important in the growth of cancer cells.~     Medical studies have shown that patients with EGFR mutation-positive lung cancer gain more~     benefit from targeted therapy drugs such as EGFR inhibitors than with standard chemotherapy.~     However, a significant proportion of patients carrying these sensitizing mutations do not~     respond well to the first-generation EGFR-TKIs (erlotinib and gefitinib), indicating the~     existence of intrinsic resistance mechanisms. Moreover, despite initial response to~     EGFR-TKIs, acquired resistance is inevitable in all patients.~      The investigators have recently shown that Cripto-1 overexpression in EGFR mutant NSCLC~     contributes to the intrinsic resistance to EGFR-TKIs through activation of the SRC oncogene.~     They have also shown that a combination of an EGFR-TKI (both erlotinib and osimertinib) and a~     Src inhibitor are synergistic in Cripto-1 overexpressing tumors in the laboratory.~      This study will be testing a combination of two drugs, dasatinib and osimertinib, to overcome~     resistance to EGFR-TKIs. Osimertinib (AZD9291) is a third-generation EGFR-TKI, which~     selectively blocks the activity of EGFR mutants, but spares that of wild type. The advantage~     of using osimertinib is that it inhibits not only the sensitizing EGFR mutations, but also~     the T790M mutant, which is the most common mechanism of acquired resistance. Dasatinib is a~     potent, orally available ABL1/SRC TKI, approved for the treatment of chronic myeloid leukemia~     (CML) in first-line and in patients with imatinib-resistant disease or intolerant, and is~     being actively studied in patients with advanced solid tumors.~      The first part of the study will involve finding the highest dose of dasatinib that can be~     given with osimertinib without causing severe side effects, finding out the side effects seen~     by giving dasatinib at different dose levels with osimertinib, and measuring the levels of~     dasatinib and osimertinib in blood at different dose levels. The second part will determine~     the effects of the combination of dasatinib and osimertinib and determine if the amount of~     Cripto-1 protein in your tumor or blood makes you more likely to have a good response to the~     combination of dasatinib and osimertinib.~   "
46784|NCT02954510|"~     There are no current alternatives to diagnostic contrast-requiring imaging for patients with~     an eGFR <30mL/min due to the association of gadolinium-based imaging modalities to~     nephrogenic systemic fibrosis and iodinated contrast-induced kidney injury.~     Ferumoxytol-enhanced imaging may offer an alternative approach.~   "
46785|NCT02954497|"~     PumpKIN is a randomized, multicenter, two-arm trial evaluating the investigational Jarvik~     2015 VAD versus the EXCOR® Pediatric VAD in pediatric patients with heart failure. This study~     will enroll 88 subjects, 44 receiving the Jarvik 2015 and 44 receiving the EXCOR®, at up to~     24 sites in the US and Canada.~      The primary objectives of this investigational device exemption (IDE) clinical investigation~     are to (1) assess the safety of the investigational Jarvik 2015 through the evaluation of~     reported serious adverse events (SAEs) while on ventricular assist device (VAD) support up to~     the first 180 days post-implant and (2) explore the probable benefit of the investigational~     Jarvik 2015 by evaluating overall survival in the absence of severe neurologic impairment.~   "
46786|NCT02954484|"~     This study aims to provide high quality evidence from a double-blinded, randomized controlled~     trial on the efficacy of perioperative pregabalin in reducing morphine requirements,~     improving pain scores and reducing chronic neuropathic pain when compared with placebo for~     primary total knee arthroplasty. It hence aims to improve on choice of analgesia adjuncts for~     total knee arthroplasty.~   "
46787|NCT02954471|"~     This is a retrospective, multicenter study, consisting of chart review of Saudi Arabian~     participants diagnosed with breast cancer between 2007 and 2013 and with available human~     epidermal growth factor receptor 2 (HER2) testing. Data on survival will be collected through~     2015.~   "
46788|NCT02954458|"~     This study will follow subjects who completed the TED-C14-006 study. The purpose of this~     study is to evaluate the long-term safety and efficacy of teduglutide in pediatric subjects~     with Short Bowel Syndrome (SBS). This study will also offer teduglutide treatment to eligible~     subjects, regardless of treatment received in TED-C14-006.~   "
46789|NCT02954445|"~     The overall purpose of this study is to explore the therapeutic effect of BCMA-targeted~     chimeric antigen receptor T(CAR-T) cells in the treatment of B-cell derived malignancies.~   "
46790|NCT02954432|"~     The purpose of this study is to assess the effects of tDCS in combination with TUS for the~     treatment of pain and functional limitations in subjects with NSCLBP. The investigators~     hypothesize that there will be a decrease in pain levels with active stimulation, when~     compared to sham stimulation.~   "
46791|NCT02954419|"~     This prospective cohort study is designed to examine the association between blood and urine~     biomarkers (including genetic variants) and long-term kidney disease progression among 2000~     Chinese IgA nephropathy patients with relatively normal kidney function (eGFR≥60 ml/min/1.73~     m2).~   "
46792|NCT02954406|"~     The purpose of this study is to determine the maximum tolerated dose (MTD) or recommended~     Phase 2 dose (RP2D) of TAK-659 when administered in combination with bendamustine,~     bendamustine + rituximab, gemcitabine, lenalidomide, or ibrutinib.~   "
46793|NCT02954393|"~     The aim of this multicenter randomized clinical trial is to compare the clinical,~     microbiological and immunological effects of the adjunctive use of systemic metronidazole~     plus amoxicillin administered in different phases of the treatment of generalized chronic~     periodontitis.~   "
46794|NCT02954380|"~     The aim of our study is to investigate if LTCM's are superior to implantable loop recorders~     in detecting atrial fibrillation after pulmonary vein isolation. This study will provide~     insights on a possible alternative for detection of arrhythmia.~   "
46795|NCT02954367|"~     The aim of this project is to investigate the potential benefits of combining a new protein~     meat hydrolysates extract with a regular endurance training programme on (a) body composition~     (b) performance (c) muscle structure (d) immunology and (e) microbiota (f) haematological~     markers in endurance athletes~   "
46796|NCT02954354|"~     The primary objective of this study is to evaluate the efficacy of a single, oral dose of~     Baloxavir Marboxil compared with placebo by measuring the time to alleviation of symptoms in~     patients with uncomplicated influenza virus infection.~   "
46798|NCT02954328|"~     The concurrent performance of two tasks, i.e., dual tasking (DT), is a common and ubiquitous~     every day phenomena. For example, people frequently walk while talking on a cellphone or~     drive while talking to a passenger. Often, the performance of one or more of these~     simultaneously performed tasks may deteriorate when another task is carried out at the same~     time, even in healthy young adults. This reduction in performance is referred to as the DT~     deficit or DT cost and is typically much higher in Idiopathic Fallers (IF) than in~     age-matched controls. In this population the DT cost impairs the gait pattern, as manifested,~     for example, in increased gait variability, exacerbating instability and fall risk.~      In the proposed study, would be evaluated the effects of tDCS on dual tasking performance~     following tDCS.~      The researchers expect that stimulation of the Pre Frontal Cortex (PFC) (using tDCS) will~     increase DT performance and prefrontal activation.~   "
46799|NCT02954315|"~     Investigators hypothesize that regular consumption of almonds will augment the long chain~     fatty acid profile and the alpha-tocopherol levels, improve the skin barrier function, and~     improve the appearance of facial wrinkles in post-menopausal women.~   "
46800|NCT02954302|"~     This study aims to evaluate whether the incidence of delayed gastric emptying (DGE) can be~     reduced by proximal Roux-en-y gastrojejunal anastomosis in comparison with the standard~     gastrojejunal anastomosis in pylorus-resecting pancreaticoduodenectomy (PrPD).~   "
46801|NCT02954289|"~     Prostate cancer is one of the most commonly diagnosed cancers in Canada, with 24,000 new~     cases estimated for 2015. Prostate cancer patients often live with uncomfortable side effects~     of treatment, such as a decrease in bone health, weight gain, and challenges to their~     interpersonal relationships. Nutrition can improve outcomes for PCa survivors; however,~     dietary interventions for prostate cancer patients are limited. Therefore, this is a~     feasibility study that tests the impact of an innovative intervention to promote healthy~     nutrition and weight control for prostate cancer survivors and their partners.~      The objectives are to assess the feasibility of the intervention, specifically:~        -  Accrual, retention and adherence, and participant satisfaction~        -  Candidate measures for primary outcomes in future studies~      The intent is to evaluate how well the classes work and identify ways to make them more~     successful. At the end of the study, the investigators will know if this approach shows merit~     to be tested further through a randomized controlled trial.~   "
46802|NCT02954276|"~     the trial is a randomized, open label, crossover, single-administration bioavailability study~     to compare the pharmacokinetic parameters of Omexa sumatriptan transmucosal sublingual tablet~     versus commercial Imitrex® sumatriptan oral tablet in 14 healthy volunteers.~   "
46803|NCT02954263|"~     Multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and~     pharmacodynamics of TD-1439 in healthy adult and elderly subjects~   "
46804|NCT02954250|"~     Background: According to the World Health Organization, one million people die by suicide~     each year worldwide and the rate of attempted suicide is ten times greater. A less known fact~     is that suicide is 3 times more frequent in elderly adults compared to younger counterpart.~     Unfortunately, predicting and preventing suicidal behaviours (SB) in general, and in elderly~     in particular, remain difficult. Clinical, biological and genetic data suggests that SB may~     be best understood according to a stress-vulnerability model where, more vulnerable~     individuals are at increased risk of committing a suicidal act when experiencing (mostly~     social) stress. Vulnerability to SB has also been associated with specific (i.e. distinct~     from comorbid psychiatric disorders like depression) neurocognitive alterations. However, the~     neurocognitive basis of suicidal behavior in elderly has been more rarely investigated.~      Aim: Mindfulness based cognitive therapy (MBCT) has been successfully used to treat many~     psychiatric symptoms in many different populations, given that this therapy reduces cognitive~     creativity. Thus, this pilot study aims at addressing the SB in older adults with a Modified~     Mindfulness Based Cognitive Therapy (MMBCT).~      Hypotheses: We hypothesise that MMBCT is not only a feasible intervention in older people~     with SB, but also, effective to treat depressive symptoms and suicidal ideation.~     Additionally, we will explore the changes in cognitive testing.~      Methods: This is a pilot randomized controlled trial of a MMBCT tailored to older adults with~     depression and suicidal behaviors at the Douglas Mental Health University Institute. Patients~     with depression Hamilton Depression Rating Scale (HAM-D) >10 and suicidal ideation (Scale for~     Suicide Ideation [SSI] score ≥1) will be randomized to MMBCT or usual care. The meditation~     intervention will involve doing seated 90minute/week meditation exercises for 8 weeks. The~     primary outcomes will examine feasibility and acceptability of the treatment. The secondary~     outcome measures will scores in HAM-D and we will control for any important covariates~     differing between groups, (e.g. age, sex, # medical illnesses).~      Perspectives: Implementation of these interventions could potentially prevent many~     consultations to psychiatry/mental health professionals. Increase quality of life, decrease~     medical comorbidity, illness and mortality. [2] Taken together, in our rapidly aging~     population, this could translate to substantial savings in health costs.~   "
46805|NCT02954237|"~     The purpose of this study is to observe the safety and effectiveness of the AMPLATZER™~     Cardiac Plug (ACP) device in Chinese population indicated for use of AMPLATZER™ Cardiac Plug~     after its market approval by China FDA (CFDA). This is a prospective, multi-centre, single~     arm, post approval, observational study. The clinical study will be conducted at up to 35~     sites in China. Approximately 343 subjects will be enrolled in this study.~      The total study duration is expected to be approximately 7 years. Patients who have~     non-valvular atrial fibrillation (NVAF) and are contraindicated to long-term oral~     anticoagulant; or patients who experience stroke or other thromboembolic event despite taking~     warfarin.~      Scheduled office visits occur at (45 days+ 2 weeks), 6M (+/- 3 weeks) 12M (+/- 6 weeks) and~     24 M(+/- 6 weeks) post procedure; Phone contact follow up visits occur at, 36 M (+/- 6~     weeks), 48M (+/- 6 weeks) and 60 M (+/- 6 weeks) post procedures.~   "
46806|NCT02954224|"~     Delirium is a common complication in elderly patients following surgery. Patients who develop~     delirium after surgery are at increased risk for serious complications, and even death.This~     multi-centre randomized controlled trial will enroll elderly patients scheduled for elective~     hip/knee replacement surgery.The objective of this trial is to identify obstructive sleep~     apnea using ApneaLink Air and to determine whether auto-titrating CPAP treatment of~     obstructive sleep apnea will decrease the incidence of post-operative delirium in elderly~     patients undergoing elective hip and knee replacement surgery.~   "
46807|NCT02954211|"~     The purpose of this study is to determine the characteristics that distinguish responders~     from nonresponders in people with stroke receiving rTMS combined with physical therapy to~     improve hand function. Investigators hypothesize that those who improve the most will be~     characterized by larger evoked brain signals in the stroke hemisphere and lower scores on the~     Beck Depression Inventory indicating less depression. Medications, sex, age, type of stroke,~     location of stroke, duration of stroke and baseline hand function will also be compared.~   "
46809|NCT02954185|"~     Preliminary evaluations have been completed and resulted in patients and therapist indicating~     positive outcomes through increased patient engagement, asynchronous communications (i.e.~     messaging) between therapists and patients, and objective assessment and monitoring of~     exercises performed by the patients. The investigator's hypothesis is that patients using the~     Wellclub device and application in addition to in-clinic physical therapy will be more~     compliant with their home exercise programs and have the same or better functional outcomes~     than patients with similar conditions who use in-clinic care only.~   "
46810|NCT02954172|"~     A randomized, double blind, multicenter phase3 study .~   "
46811|NCT02954159|"~     The aim of this study is to assess if a combination therapy of tacrolimus and vedolizumab is~     superior to vedolizumab monotherapy for induction of remission in moderate to severe UC, and~     its effect on long and short-term outcomes including colectomy rate. Secondary aim of this~     study is to assess the safety of tacrolimus as an induction agent in patients with UC.~   "
46812|NCT02954146|"~     The purpose of this study is to examine feasibility, tolerability, utilization, and~     effectiveness of using the SupportTeam mobile application in the context of Cognitive~     Behavioral Therapy (CBT) for veterans with PTSD.~   "
46813|NCT02954133|"~     The aim of the study is to determine if, and to what degree photobiomodulation treatment with~     OrthoPulse has an effect on the rate of tooth movement during alignment for patients~     receiving Invisalign orthodontic aligner treatment.~   "
46814|NCT02954120|"~     Background: The aim of this study was to investigate the levels of malondialdehyde (MDA),~     total antioxidant status (TAS), 8-hydroxy-2´- deoxyguanosine (8-OHdG) in blood serum and~     saliva samples in female patients with chronic periodontitis (CP) and to compared healthy~     individuals.~      Materials and Methods: A total of 88 women were into four groups each which were consisted of~     twenty-two subjects. Groups were designed as periodontally and systemically healthy women~     (PCOS-CP-); periodontally healthy women with polycystic ovary syndrome (PCOS) (PCOS+CP-),~     systemically healthy women with CP (PCOS-,CP+) and women with PCOS and CP (PCOS+CP+). Serum~     and salivary samples were obtained, clinical periodontal parameters were recorded. MDA, TAS,~     8-OHdG levels were measured as biochemically.~   "
46815|NCT02954107|"~     This longitudinal study will focus on the cognitive and brain development of children with~     absence epilepsy. In addition, the investigators aim to identify prognostic factors for~     cognitive deterioration and/or poor seizure control in these children.~   "
46816|NCT02954094|"~     TARGET-HCC is a longitudinal, observational study of patients being managed for HCC in usual~     clinical practice. TARGET-HCC will create a research registry of participants with HCC within~     academic and community real-world practices in order to assess the safety and effectiveness~     of the entire spectrum of current and future therapies across diverse populations.~   "
46817|NCT02954081|"~     Patient treatment preference and treatment satisfaction of physicians and patients comparing~     fumaric acid ester therapy with subsequent apremilast treatment~   "
46818|NCT02954068|"~     This double-blind, randomized controlled trial will evaluate the effect of the route of~     administration of 10 IU of oxytocin on the average blood loss postpartum. Participants will~     be randomized to receive 10 IU of oxytocin by IV infusion or 10 IU of oxytocin by injection~     IM~   "
46819|NCT02954055|"~     This is a multi-center, randomized phase II trial that will randomise women with ER-positive,~     HER2-negative (Human Epidermal Growth factor Receptor 2-negative) metastatic or locally~     relapsed breast cancer in a ratio of 1:1 to receive a metronomic regimen of vinorelbine plus~     cyclophosphamide and capecitabine, or the conventional paclitaxel monotherapy.~   "
46820|NCT02954042|"~     The purpose of this investigation is to compare the clinical benefits of using the Pelvital~     product, in comparison to a sham procedure as a noninvasive treatment for female incontinence~   "
46821|NCT02954029|"~     Arterial access is the key step during the endovascular treatment of cardiovascular diseases.~     This study was designed to confirm the safety and efficacy of the hemostasis pad using~     chitosan in patients undergoing percutaneous procedures with arterial approach. Two cohorts~     will be included in this study: transradial and transfemoral cohort. Among the transfemoral~     cohort, the safety and efficacy of the ezClot pad will be compared with the BloodSTOP® pad~     (LifeScience PLUS, Palo Alto, CA, USA). The BloodSTOP® pad is an etherized and oxidized~     regenerated cellulose matrix that achieves hemostasis by activating the intrinsic coagulation~     pathway. The hypothesis will be tested among the transradial cohort that the combined use of~     a hemostasis pad and a compression device is superior to that of a compression device only in~     terms of hemostasis in patients who underwent tranradial coronary procedures.~   "
46822|NCT02954016|"~     To evaluate the safety and efficacy of the endoscopically implanted ValenTx EndoPass™ System~     for treatment of adults with severe obesity.~      The EndoPass System is indicated for weight loss in adults with a body mass index (BMI) ≥35~     and ≤ 50 kg/m2 who have failed more conservative weight loss methods.~   "
46823|NCT02954003|"~     The purpose of this study is to collect clinical data to support the use of the ValenTx Endo~     Bypass System to improve weight loss and the resolution of comorbidities in obese subjects.~   "
46824|NCT02953990|"~     This study will provide information about the feasibility, acceptability, and preliminary~     effects of a biobehavioral self-management approach for perinatal depressive symptoms. This~     line of research will contribute to the body of knowledge about adjunctive therapies for~     depressive symptoms in pregnancy, a serious problem which contributes to poor maternal-child~     outcomes. Ultimately, this will contribute to the development and implementation of~     theoretically driven depression prevention/ resiliency building interventions and measurement~     of appropriate biobehavioral outcomes to determine the effectiveness of interventions.~   "
46825|NCT02953977|"~     SMSC will inform the design and implementation of culturally informed, community-based~     lifestyle interventions for diabetes prevention in AI men in our partner communities and~     elsewhere, as well as in men of other minority groups who experience a heavy burden of~     diabetes.~   "
46826|NCT02953964|"~     The purposes of the study are:~        -  To evaluate the effectiveness of a perceptual-based training program in enhancing~          cognitive and everyday functioning of older adults with mild cognitive impairment and~          mild dementia~        -  To evaluate the effectiveness of a semantic-based training program in enhancing~          cognitive and everyday functioning of older adults with mild cognitive impairment and~          mild dementia~   "
46827|NCT02953951|"~     The hemolytic product free-hemoglobin (fHb) reduces nitric oxide (NO) bioavailability. The~     present study aims to establish whether transfusions of stored allogenic blood or~     intraoperative autologous salvaged blood result in increased circulating fHb levels and NO~     consumption with effects on arterial NO-dependent blood flow measured in isolated left~     mammary artery rings and by peripheral artery tonometry in patients undergoing CABG surgery.~   "
46828|NCT02953938|"~     This is a Phase IV, randomized, open-label, active-controlled, 2-arm, multicenter study. The~     primary objective will be assessed by the difference in the mean number of ranibizumab~     injections applied up to Month 11 between the 2 treatment arms. Patients will be randomized~     in a 1:1 ratio to 1 of the 2 treatment arms; i.e. Arm 1 ranibizumab monotherapy, Arm 2~     ranibizumab with Grid&Direct short pulse laser photocoagulation combination therapy. There~     will be 3 periods in this study: Screening Period (visit 1), Treatment Period (visit 2 to~     Visit 13) and Follow-up Period (visit 14). In addition to screening and Baseline (visit 2),~     there will be monthly visits from Month 1 to Month 12. This study will include male and~     female patients (≥20 years old) diagnosed with visual impairment due to ME secondary to BRVO.~     Assuming an approximate 20% drop out rate, approximately 70 patients will need to be screened~     to have at least 56 patients found eligible and commencing treatment in the trial.~   "
46829|NCT02953925|"~     The survey aims to support health policy making, this survey aims to comprehensively assess~     the capability and quality of PHC in different regions in China. The study is based on the~     China PEACE MPP network, including about 4000 rural and urban primary health care~     institutions scattered over 31 provinces in Mainland China. The investigators intended to~     enroll about 30,000 PHC healthcare providers. Meanwhile, the investigators drew a random~     samples (>50,000) of patients from MPP high-risk of CVD population. In this survey, data on~     structure, process, and outcome of PHC system in China will be collected by questionnaires,~     specified by organization, healthcare providers and patients. Meanwhile, the investigators~     will collect the original documents from participating PHC institutions, covering the aspects~     of finance, employment, essential medical list (EMS), public health service report and~     prescriptions. The investigators will analyze data in align with key indicators, to assess~     the capability and quality of PHC across different regions in China.~   "
46830|NCT02953912|"~     To show whether One Shape rotary system differs from Reciproc reciprocating system in~     postoperative pain in patients with symptomatic irreversible pulpitis.~   "
46831|NCT02953899|"~     The purpose of this project is to pilot contingency management as an adjunct treatment to~     counselling as usual using internet delivered video-conferencing applications for remote~     disordered gamblers. This project further investigates the impact of adding contingency~     management to counselling to improve counselling attendance and retention and uses~     internet-delivered approaches to assist rural and remote disordered gamblers gain access to~     counselling treatments.~   "
46832|NCT02953886|"~     The study will compare bacteria levels in cavities before and after silver diamine fluoride~     (SDF) treatment.~   "
46833|NCT02953873|"~     Compare the difference in dose-normalized trough and total daily dose necessary to reach the~     steady state therapeutic goal after conversion from tacrolimus IR to Astagraf XL® in African~     American kidney transplant recipients.~   "
46834|NCT02953860|"~     A phase 2 study to evaluate the tolerability and clinical activity of adding enzalutamide to~     fulvestrant treatment in women with advanced breast cancer that are ER and/or PR positive and~     Her2 normal.~   "
46835|NCT02953847|"~     3-way cross-over single dose design evaluating bioavailability of 2 rifampicin-containing~     FDCs vs a single drug comparator in healthy volunteers~   "
46836|NCT02953834|"~     This study examines how a naturally occurring peptide called Kisspeptin might regulate blood~     sugar and insulin levels.~   "
46837|NCT02953821|"~     Subjects with active systemic lupus erythematosus (SLE) will be randomized to receive Acthar~     or placebo. Active treatment will continue for 24 weeks. Efficacy will be assessed at~     multiple timepoints using the SLE Responder Index (SRI), SLEDAI-2K, BILAG, PGA, CLASI and 28~     Joint Count~   "
46838|NCT02953808|"~     This is the first study in which GSK2315698 will be administered in Japanese population. The~     primary objective of the study is to investigate safety and tolerability, pharmacokinetics,~     and pharmacodynamics after single intravenous infusion in healthy subjects. This will be a~     single center, double-blind, randomized, placebo-controlled, dose-ascending study.~      Subjects in Cohort 1 will attend 3 dosing sessions, and will be randomized to one of the 3~     groups. Each group will receive GSK2315698 and Placebo in a defined sequence. The dose levels~     of GSK2315698 are set to 10 milligrams (mg) per hour (hr), 20 mg/hr, and 40 mg/hr, to be~     administered over 1 hour. Dosing sessions 1 and 2, and dosing sessions 2 and 3, will be~     separated by a washout period of at least 8 and 10 days, respectively.~      Subjects in Cohort 2 will attend a single dosing session, and will be randomized to receive~     either GSK2315698 20 mg/hr or Placebo, over a period of 15 hours.~      A sufficient number of subjects will be randomized such that 18 subjects (9 in each cohort)~     complete the study. The duration of participation for any subject in this study will be~     approximately 59 days.~   "
46839|NCT02953782|"~     This trial will evaluate Hu5F9-G4 in combination with cetuximab. Hu5F9-G4 is a monoclonal~     antibody which is designed to block a protein called CD47, which is widely expressed on human~     cancer cells. Blocking CD47 with Hu5F9-G4 may enable the body's immune system to find and~     destroy the cancer cells. Cetuximab is a monoclonal antibody drug that is used for treatment~     of certain types of colorectal cancer as well as head and neck cancer.~      The major aims of the study are: (Phase 1b) to define the safety profile and to determine a~     recommended Phase 2 dose for Hu5F9-G4 in combination with cetuximab, and (Phase 2) to~     evaluate the objective response rate of Hu5F9-G4 in combination with cetuximab in patients~     with advanced colorectal cancer.~   "
46840|NCT02953769|"~     Comparison of ventral hernia repair using standard wound care versus Prevena.~   "
46841|NCT02953756|"~     Stereotactic radiosurgery (SRS) is increasingly applied in patients with brain metastases~     (BM) and is expected to have less adverse effects on cognitive functioning than Whole Brain~     Radiation Therapy (WBRT). Because cognitive functions are essential for daily functioning,~     and may affect therapy compliance and quality of life in general, a full understanding of~     cognitive functioning in patients with BM after SRS is essential.~      CAR-Study A is a prospective study to evaluate cognitive functioning in patients with 1-10 BM~     accepted for treatment with Gamma Knife radiosurgery (GKRS).~   "
46844|NCT02953717|"~     Whole Brain Radiation Therapy (WBRT) has long been the mainstay of treatment for patients~     with multiple brain metastases (BM). Meanwhile, Gamma Knife radiosurgery (GKRS) has been~     increasingly employed in the management of multiple BM to spare healthy tissue. Hence, GKRS~     is expected to cause fewer cognitive side effects than WBRT. Treatment of multiple BM without~     cognitive side effects is becoming more important, as more patients live longer due to better~     systemic treatment options. There are no published randomized trials yet directly comparing~     GKRS to WBRT in patients with multiple BM, including objective neuropsychological testing.~      CAR-Study B is a prospective randomized trial comparing cognitive outcome after GKRS or WBRT~     in eligible patients with 11-20 BM.~   "
46845|NCT02953704|"~     The purpose of this prospective, longitudinal, noninterventional study is to describe~     clinical characteristics, evolution of disease burden, and treatment patterns in patients~     with select subcategories of essential thrombocythemia (ET) or myelofibrosis (MF).~   "
46846|NCT02953691|"~     The overall objective of this proposal is to explore the association between the~     administration of the prebiotics GOS (trade name: Bimuno Travelaid; generic name:B~     galacto-oligosaccharides) with pain, anxiety, and cognitive function in the perioperative~     period. The investigators' central hypothesis is subjects who consume GOS in the~     perioperative period will demonstrate lower levels of salivary cortisol before, during, and~     after their operative procedures. In addition, the investigators expect subjects who consume~     GOS to have lower perceived levels of anxiety during the perioperative period. Finally, the~     investigators hypothesize that subjects who consume perioperative GOS will perform better on~     tests of cognition in the postoperative period. Such a finding would be beneficial in that~     administration of GOS in the perioperative period offers a safe and inexpensive adjunct to~     current medical management of perioperative anxiety.~   "
46847|NCT02953678|"~     The purpose of this study is to assess the efficacy of ruxolitinib in combination with~     corticosteroids in subjects with Grades II to IV steroid-refractory acute graft-versus-host~     disease (GVHD).~   "
46848|NCT02953665|"~     The purpose of this study is to test the efficacy and safety of liraglutide in the treatment~     of patients with idiopathic Parkinson's disease (PD).~   "
46849|NCT02953652|"~     Phase 2b, open-label, non-randomized, single arm study to evaluate the safety, efficacy, and~     pharmacokinetics of HBI-8000 40 mg BIW in patients with relapsed or refractory PTCL (R/R~     PTCL).~   "
46850|NCT02953639|"~     This multicenter study will assess the effects of 24 weeks of basmisanil treatment on~     cognition and functioning of stable schizophrenia participants treated with antipsychotics.~   "
46851|NCT02953626|"~     Postpartum depression is common, yet only 20% of women seek treatment. Online support groups~     are a potential means of providing accessible mental health care during this time. Mother~     Matters is a 10-week online psychotherapy group for women with postpartum depression &~     anxiety. The investigators aim to conduct a pilot RCT to demonstrate the feasibility of~     proceeding to a large-scale RCT evaluation of the Mother Matters intervention.~   "
46852|NCT02953613|"~     The goal of this study is to correlate both plaque and % lipid core content assessed by~     NIRS-IVUS (Imaging technique) to plaque burden and % lipid core content in coronary~     computerized tomographic angiography (CCTA) completed at 1 week in non-culprit coronary~     arteries.~   "
46853|NCT02953600|"~     Hepatocellular carcinoma (HCC) is a very severe disease in Taiwan caused 7,000 deaths per~     year, and majorly about 70% is caused by the chronic hepatitis B virus infection. A repeat,~     long-term, and severe chronic hepatitis would be more possible progressed into liver~     cirrhosis and HCC. As previous records, there might be 2% of chronic HBV patient would~     progress to liver cirrhosis, and 5% of the liver cirrhosis's patients would develop to HCC.~     In some cases, the HBV patient also might directly develop to HCC without liver cirrhosis~     phase.~   "
46854|NCT02953587|"~     The purpose of this study is to determine if the altered nutrient exposure to the GI tract~     after bariatric surgery reveals a negative incretin effect of ghrelin.~   "
46855|NCT02953574|"~     The purpose of this study is to determine if the daily performance of a 7 step bedtime~     nursing protocol for hospitalized people living with dementia is feasible and if it has an~     effect on bedtime and daytime variables.~   "
46856|NCT02953561|"~     This clinical research study has 2 parts: Part A and Part B.~      The goal of Part A is to find the highest tolerable dose of avelumab that can be given in~     combination with 5-azacytidine to patients with relapsed or refractory AML. The goal of Part~     B is to learn if the highest tolerable dose of this drug combination found in Part A can help~     to control the disease.~      The safety of this drug combination will also be studied in both parts of the study.~      This is an investigational study. Avelumab is not FDA approved or commercially available. It~     is currently being used for research purposes only. 5-azacytidine is FDA approved for the~     treatment of myelodysplastic syndrome (MDS). Its use in combination with avelumab is~     investigational. The study doctor can explain how the study drugs are designed to work.~      Up to 58 participants will be enrolled in this study. All will take part at MD Anderson.~   "
46857|NCT02953548|"~     This trial consists of 3 parts: a pilot safety phase, a pivotal randomized controlled phase,~     and an open-label extension phase. The pilot phase only will be described in this record. 2~     cohorts of 5 participants will be enrolled sequentially. All participants will receive~     GWP42003-P.~   "
46858|NCT02953535|"~     Comparative randomized, single dose, three way three sequence two treatment partial replicate~     crossover open-label study to determine the bioequivalence of Sofosbuvir from Magicbuvir 400~     mg Film Coated Tablets ( Magic Pharma, Egypt) Versus Sovaldi 400 mg Tablets (Gilead Sciences,~     Canada)~   "
46872|NCT02953353|"~     The overall goal of this proposal is to evaluate the efficacy of transcranial direct current~     stimulation (tDCS), a noninvasive neuromodulation technique, to facilitate weight loss and~     weight loss maintenance in obesity. This is a novel clinical research study that examines the~     therapeutic potential of an innovative biomedical treatment for weight loss.~   "
46873|NCT02953340|"~     The purpose of this study is to compare the efficacy of SPI-2012 with pegfilgrastim in~     patients with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC) to~     prevent and reduce Neutropenia that is associated with cancer chemotherapy.~   "
47622|NCT02943564|"~     This study will evaluate the efficacy, safety, and tolerability of two doses of rapastinel,~     225 milligrams (mg) and 450 mg, compared to placebo adjunctive to antidepressant therapy~     (ADT) in patients with major depressive disorder (MDD) who have a partial response to ADT.~   "
46859|NCT02953522|"~     The C677T polymorphism in the MTHFR gene is related to several significant biochemical~     changes, as dyslipidemia, changes in serum levels of homocysteine, folic acid, vitamin B12~     and some oxidative stress markers such as the CAT and MDA, leading to a high risk of the~     emergence of cardiovascular disease (CVD). A diet containing antioxidants, especially folate,~     is characterized by being beneficial for individuals with this genetic alteration to possess~     anti-inflammatory function, act on and oxidative stress play an important gene function. The~     aim of this study was to evaluate the influence of the C677T polymorphism of the MTHFR gene~     and the effect of a diet containing folate on oxidative stress, lipid profile and~     homocysteine levels in adult women are overweight or obese. This is an intervention study,~     double-blind, held in a city in northeastern Brazil. The study included 48 adult women (20-59~     years old) with BMI of 26.19 kg / m² and 49.64 kg / m², in which we evaluated the CAT levels,~     MDA, lipid profile, folic acid, homocysteine and vitamin B12 addition genotyping for the~     C677T polymorphism in the MTHFR gene and the food consumption by the food recall 24 hours,~     being divided by randomization into two groups received daily for 8 weeks, 300g vegetables~     rich in folate containing 191 ug and 90 ug of this nutrient.~   "
46860|NCT02953509|"~     This Phase 1b/2 trial will evaluate Hu5F9-G4 in combination with rituximab. Hu5F9-G4 is a~     monoclonal antibody which is designed to block a protein called CD47, which is widely~     expressed on human cancer cells. Blocking CD47 with Hu5F9-G4 may enable the body's immune~     system to find and destroy the cancer cells. Rituximab is a monoclonal antibody drug that is~     used for treatment of non-Hodgkin's lymphoma and other types of cancer.~      The major aims of the trial are: (Phase 1b) to investigate the safety and tolerability of~     sequential dose cohorts and to determine a recommended Phase 2 dose for Hu5F9-G4 in~     combination with rituximab, and (Phase 2) to evaluate the efficacy of Hu5F9-G4 in combination~     with rituximab in patients with indolent lymphoma or diffuse large B-cell lymphoma as~     measured by the overall response rate.~   "
46861|NCT02953496|"~     The research study is designed to assess the technical feasibility and safety of percutaneous~     administration of vonapanitase to the superficial femoral or popliteal artery in patients~     with PAD.~   "
46862|NCT02953483|"~     The lungs retrieved from the brain dead multi organ donor will be placed in a lab . They will~     be connected to a ventilator and preservative solution will be circulated through it . Blood~     will be added to the fluid depending on the group to which the lungs are allocated and its~     effects on lung function will be seen~   "
46863|NCT02953470|"~     The aim for the study is to examined the effect of an individually tailored integrated~     behavioral medicine in physiotherapy intervention including functional exercise, for older~     adults, having chronic musculoskeletal pain, living alone and dependent on formal care.~      The study is a pragmatic randomized controlled trial with one intervention group and one~     control group. The intervention is a 12-weeks home-based program. The intervention consists~     of an individually tailored intervention and aims to enhance ability to perform everyday~     activities by improving physical function and reduce pain-related beliefs and pain-related~     disability. The comparison group achieves general advice about physical activity. All~     participants will be tested at baseline, a post-assessment at 12 week and a three month~     follow-up. Primary outcome is pain interference by the Brief Pain Inventory and physical~     function by Short Physical Performance Battery.~      Secondary outcomes measures if the goal setting is reached, self-efficacy in relation to the~     goal setting, pain catastrophizing, level of physical Activity, falls efficacy and Health~     related quality of life.~   "
46864|NCT02953457|"~     This phase I/II trial studies the side effects and best dose of olaparib when give together~     with durvalumab and tremelimumab and to see how well they work in treating patients with~     ovarian, fallopian tube, or primary peritoneal cancer with BRCA1 or BRCA2 genetic mutation~     that has come back or has not responded to treatment. Drugs, such as olaparib, may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth and kill tumors~     cells with BRCA1 or BRCA2 mutation. Monoclonal antibodies, such as durvalumab and~     tremelimumab, may help stimulate the immune system in different ways to attack and stop tumor~     cells from growing. Giving olaparib with durvalumab and tremelimumab may work better in~     treating patients with ovarian, fallopian tube, or primary peritoneal cancer.~   "
46865|NCT02953444|"~     This study will assess the efficacy of brief mindfulness practices on improving mental health~     in adults who are currently in treatment for mental health concerns. From online~     instructional videos, each participant will learn a thirty-second or three-minute mindfulness~     practice that is to be performed at least three times daily over two weeks.~   "
46866|NCT02953431|"~     This is an early phase clinical trial to test the efficacy of elevating lung volume with~     positive expiratory pressure (PEEP) as a controller therapy for asthma in patients with a BMI~     ≥ 35 kg/m2.~      There will be two phases to this trial.~      Phase I:~      In the first phase we will determine the optimal duration of PEEP that is effective as a~     controller therapy in asthma. Up to 9 participants will complete this this phase.~      Phase II:~      The 2nd phase will be a randomized double-blinded controlled trial of PEEP 0 versus PEEP 10~     (using the duration of PEEP determined in phase I) as a controller therapy for asthma. Twenty~     participants will complete this phase.~   "
46867|NCT02953418|"~     Multicenter, prospective cohort clinical trial in greater China~   "
46868|NCT02953405|"~     Prescription and Persistence of Antithrombotic agents in Acute Ischemic Stroke or Transient~     Ischemic Attack Patients with MCA(Middle Cerebral Artery) Disease.~   "
46869|NCT02953392|"~     Sixty patients with partially edentulous posterior maxilla requiring a transcrestal sinus~     floor elevation technique to insert one implant will be selected. The purpose of this~     multi-center, prospective, double blind, and randomized investigation is to analyze a~     platform switched implant when placed at limited maxillary residual bone height with low bone~     density compared to a platform matching implant with or without bone graft material.~   "
46870|NCT02953379|"~     The purpose of this study is to evaluate the non-inferiority of the clinical efficacy of the~     mometasone nasal gel in the treatment of allergic rhinitis.~   "
46871|NCT02953366|"~     The purpose of this study is to evaluate the non-inferiority of the clinical efficacy of the~     mometasone nasal gel in the treatment of allergic rhinitis.~   "
47820|NCT02940977|"~     1. To elucidate the role of CTC detection in the evaluation of risk level in PCa patients,~          and establish a mathematic model for predicting the pathological status.~        2. To explore the possible subtle change in CTC condition after radical prostatectomy.~   "
46874|NCT02953327|"~     The propose is to test innate immune training in a pilot study of 40 adults >50 years of age~     people in Guinea-Bissau. The hypothesis is that BCG vaccination will be associated with~     increased innate immune training measured as increased cytokine release after in vitro~     Peripheral Blood Mononuclear Cells (PBMC) stimulation with e.g. Mycobacterium Tuberculosis,~     Staphylococcus Aureus, Candida Albicans and Streptococcus Pneumoniae.~   "
46875|NCT02953314|"~     This is a Phase 3, 2-part (Part A and Part B), open label, multicenter study evaluating the~     PK, safety, and tolerability of multiple doses of VX-661 in combination with ivacaftor in~     subjects 6 through 11 years of age with CF who are homozygous or heterozygous for the~     F508del-CFTR mutation.~   "
46876|NCT02953301|"~     The purpose of this study is to determine whether resminostat will be able to delay or~     prevent worsening of disease in patients with advanced stage mycosis fungoides or Sézary~     Syndrome that have recently achieved disease control with previous systemic therapy.~   "
46877|NCT02953288|"~     To investigate the genetic mutations of patients with thyroid carcinoma and find molecular~     targets for therapy.~   "
46878|NCT02953275|"~     The purpose of this study is to determine the synergistic effect and clinical benefits of~     vedolizumab and pentoxifylline in the management of patients with inflammatory bowel disease.~   "
46879|NCT02953262|"~     Patient-facing eHealth technologies are those that connect patients and the healthcare~     system, and include online patient portals. Although many organizations are adopting patient~     portals, there is limited understanding of how the different portal features help improve~     health outcomes. This study is designed to develop and test an intervention to improve~     adoption and use of patient portal features for diabetes management.~   "
46880|NCT02953249|"~     Dental treatment to individuals with diabetes mellitus, particularly type 1 diabetes (T1DM),~     has always represented a challenge to the dentist. The literature provides some scientific~     evidence showing that diabetes is a risk factor for the occurrence of oral opportunistic~     infections, abnormal bone metabolism and delay in tissue repair, but with varying degrees of~     evidence.~      Hyperglycemia, as well as diabetes, are known as risk factor for post-surgical infections, so~     maintaining the glycemic control in the postoperative period has been standard to health~     care. However, there are few studies on the impact of the glycemic control in the repair~     process after tooth extractions. And, to our knowledge, there aren't evidences that~     infections resulting from oral surgery are more frequent in individuals with diabetes or that~     the antibiotics prophylaxis is needed for these individuals before invasive dental~     procedures.~      Some prospective studies show that people with diabetes, especially type 2 (T2DM), do not~     exhibit higher frequency of complications in repair process after tooth extractions compared~     to healthy individuals without diabetes. Recently, the study conduct by Fernandes et al.,~     2015, found higher frequency of delay on epithelial covering of the alveolus after 21 days of~     tooth extraction in individuals with T2DM, comparing to a control group. Delay was not~     related to infection and on the day 60th after surgery, all alveolus were totally~     epithelized. One of the author's hypothesis for the delay in the alveolar epithelialization~     on the participants with T2DM was the possible reduction of Epithelial Grow Factor (EGF) in~     saliva of these individuals. Some studies already demonstrated the reduction in salivary~     detection of EGF in individuals with diabetes.~      There aren't prospective studies in the literature at our disposal, that evaluated~     intraoperative complications of tooth extractions of teeth already erupted in individuals~     with T1DM, or even post tooth extraction healing and the chronology of epithelialization of~     the alveolus and its relation with the degree of salivary EGF.~      The aim of this study is to evaluated the intraoperative events and the post- tooth~     extraction healing, regarding the chronology of the repairing events and the occurrence of~     postoperative complications in individuals with T1DM compared to a control group. Besides,~     this study intend to relate the time of complete epithelial covering of the alveolus with the~     EGF collected by whole stimulated saliva.~   "
46881|NCT02953236|"~     This study aimed to verify the mechanical and clinical effects of instrumented massage on~     myofascial trigger points of trapezius muscle in adult subjects.~   "
46882|NCT02953223|"~     To assess the frequency and nature of adverse events in infants fed a free amino acid based~     infant formula.~   "
46883|NCT02953210|"~     The use of opioid during surgery can cause side effects and may delay hospital discharge.~     Some studies have shown balanced sparing opioid anesthesia can optimize the side effects and~     and the time of discharge. In this compared controlled randomized study the aim is to~     evaluate the intraoperative and postoperative pain, hemodynamic effects, nausea/vomiting,~     postoperative ileus, sedation, urinary retention, time of discharge PACU Post anesthesia care~     unit and hospital.~   "
46884|NCT02953197|"~     Treatment of cancers of the head and neck, including oropharyngeal tumours, usually consist~     of a combination of radiotherapy and chemotherapy, although surgery may also play a part.~     Radiotherapy works by using the high energy x-rays to destroy cancer cells. Head and neck~     cancers often respond well to radiotherapy in the first instance and a proportion of patients~     will be cured by this treatment. However, not all of the cancer cells are destroyed by the~     combination of radiotherapy and chemotherapy and, in some patients, the cancer does come~     back.~      Studies have suggested that more efficient killing of cancer cells, and therefore, better~     cure rates, can be achieved by increasing the radiotherapy dose. However, in the past, this~     was not possible due to side effects. Intensity Modulated Radiotherapy (IMRT) is a new~     radiotherapy delivery technique that allows better shaping of the dose to the areas that need~     irradiating with the potential for fewer side effects. If the investigators use IMRT to~     deliver an intentionally higher dose of radiation (called a boost) to small selected areas~     whilst, at the same time giving standard treatment doses to the remaining areas, this~     approach is called IMRT dose-painting. These selected areas can be identified by a scan~     called 18F-FDG-PET (18F-fluorodeoxyglucose-positron emission tomography, also known as a~     'PET' scan) which is a type of scan that can give information about the activity of a cancer.~      The purpose of this study is to find out whether the investigators can use IMRT dose-painting~     to boost the dose to the region inside a tumour which appears most active on 18F-FDG-PET. If~     this study shows that this approach is well-tolerated, then the investigators may be able to~     improve cure rates with this treatment. This would need to be tested in a subsequent study.~   "
46885|NCT02953184|"~     The regimen PLD plus cyclophosphamide 4 cycles followed by paclitaxel or docetaxel 4~     cycles(noted in phase II CAPRICE) will be used as experimental group. The regimen will be~     compared to the standard treatment of doxorubicin plus cyclophosphamide(AC) 4 cycles followed~     by paclitaxel or docetaxel 4 cycles[noted in National Comprehensive Cancer Network (NCCN)~     guideline].~   "
46886|NCT02953171|"~     The aim of the present study is to assess the efficacy of two different probiotic products,~     lacto-fermented sauerkraut and the supplement Mutaflor, in the treatment of irritable bowel~     syndrome.~   "
46887|NCT02953158|"~     This study will compare two energy reduced diets; one diet will include one Haas avocado/day~     while the other diet will follow the usual American dietary pattern. All subjects will~     receive a dietary plan that reduces their usual intake by 500kcal/day with the same~     percentage of fat, protein and carbohydrates. The results from this study may help to explain~     if eating one Haas avocado/day can achieve at least equivalent weight loss when compared to~     the usual American diet.~   "
46888|NCT02953145|"~     Cleft Palate is a condition which affects up to 1 in 500 live births. Current treatment is~     surgery to correct the underlying anomaly. Children born with cleft palate typically undergo~     surgery at age 12 months. Standard ways to stop surgical bleeding include direct pressure and~     the use of electrocautery (burning of the tissue). Other products are available to help~     lessen blood loss. One of these includes a fibrin sealant. Fibrin is the key component of a~     blood clot. When a fibrin sealant is applied there are a variety of potential benefits other~     than bleeding control. One of these is decreased pain post operatively It is the~     investigators belief that the use of a fibrin sealant, Tisseel, in cleft palate surgery will~     decrease pain and enhance the recovery of children who undergo cleft palate repair.~      The proposed study will randomly select children undergoing cleft palate repair to have~     tisseel used on the incision. Through statistical tests 40 children will be recruited (20 to~     have tisseel used and 20 with no tisseel). The use of tisseel will be known to the surgeon~     but not to the recovery room or ward nursing staff. Post operatively, the FLACC pain scale~     will be used to score the pain of the children throughout their admission to the Stollery~     children's hospital. The amount of pain controlling medication required as well as time to~     discharge will also be recorded. Statistical analysis of the data will be performed using~     accepted methods. Overall, the investigators hope to show that fibrin sealant, tisseel, will~     less the amount of post operative pain experienced by children undergoing cleft palate~     repair.~   "
46889|NCT02953132|"~     The purpose of this study is to investigate the safety and tolerability of ascending single~     and multiple oral doses of MT-4129 in healthy subjects.~   "
46890|NCT02953119|"~     Major abdominal surgery is a great stressor to patients and causes large physiological~     changes, leads to tissue trauma, immobility, psychological distress and reduced quality of~     life. Physical capacity appears to be an important predictor for postoperative recovery after~     major abdominal surgery. Prehabilitation is a concept that challenges the traditional models~     of recovery by initiating the recovery process preoperatively. Improvement of physical~     capacity by means of prehabilitation may facilitate better recovery after surgery. More~     specifically prior to major abdominal surgery, preoperative exercise therapy is associated~     with improved physical fitness of patients, but whether or not this results in fewer~     complications or faster convalescence remains unclear.~      The aim of the present study is to evaluate the impact of preoperative physical exercise~     training (prehabilitation) on postoperative recovery and clinical outcomes after major~     abdominal surgery.~   "
46891|NCT02953106|"~     Single centre, double-blind, placebo controlled, adaptive design, cross-over trial. The~     primary objective is to assess the additive effects of using combined intranasal fluticasone~     propionate plus azelastine nasal spray on airway hyperresponsiveness. This is in patients~     with persistent asthma and allergic rhinitis, receiving inhaled steroid.~   "
46892|NCT02953093|"~     The investigators are studying the effects of acarbose on muscle and adipose gene~     transcription in older adults.~   "
46893|NCT02953080|"~     PROTOCOL SUMMARY Abstract Current estimates point towards a huge increase in the number of~     people that are eligible to start ART in Uganda and globally. As many of the newly eligible~     patients are largely asymptomatic, there are concerns about adherence and retention of these~     individuals and especially those starting ART with a higher CD4 counts. Urgent information is~     required to plan for implementation of most recent WHO and National guidelines in the most~     cost effective manner as well as maximizing retention of HIV positive individuals in care and~     achieving virological suppression.~      We plan to undertake research designed to see if we can optimize adherence, virological~     outcomes and HIV knowledge, in order to give an overall increased quality of life in~     vulnerable populations starting or established on ART in Kampala, Uganda. We will test~     implementation of an open source software-based tool to send text messages and to give access~     to an interactive voice response system to support self-monitoring and provide health~     information using patients' mobile phones.~      We aim to undertake an open labeled randomised trial at two sites: the IDI which is an urban~     center of excellence in HIV care, and Kasangati Health Center, which is a peri-urban public~     health care facility. The project aims to enroll patients starting ART, already established~     on first line ART or switching to second line ART. We will include special populations~     including pregnant women, discordant couples and young people. The estimated length of the~     project is 30 months. The technology to be evaluated in this study is based on CONNECT FOR~     LIFETM m-health technology (CFL2015.01 or higher). CFL2015.01 provides text messages or~     Interactive Voice Response (IVR) functionalities, a technology that allows a computer to~     interact with humans through the use of voice and tones input via keypad, including pill~     reminders, clinic visit reminders, health tips and functionality to support symptom~     reporting.~      The Primary Objective of this study is to determine the effect of the CFL2015.01 tool on~     quality of life of HIV patients receiving care at IDI and Kasangati HCIV. At the start of the~     intervention, all patients will undergo quality of life assessment, which will be repeated at~     months 6, 12 and 24 months. The scores will be compared to assess the effect of the tool on~     quality of life. The Secondary Objectives are virological outcomes baseline, 6, 12 months and~     24 months, retention in care, aversion of early treatment failure, disease knowledge, clinic~     attendance and cost analysis.~   "
46894|NCT02953067|"~     This trial is designed to compare different treatments on Lisfranc fractures. The trial~     consist of 2 different strata. Stratum 1: In mild injuries the comparison is between~     conservative treatment and operative treatment with open reduction and internal fixation~     (ORIF). Stratum 2: In severe injuries the comparison is between operative treatment with open~     reduction and internal fixation (ORIF) and primary arthrodesis. The primary outcome measure~     will be AOFAS Midfoot Score, and secondary outcome measure will be VAS Foot and Ankle.~   "
46895|NCT02953054|"~     The purpose of this study is to evaluate whether the DMTS, compared with a placebo patch,~     will provide adequate pain relief during the first 3 days following bunionectomy surgery.~   "
46896|NCT02953041|"~     The study will assess the effects of two drugs, glycopyrronium and indacaterol, taken either~     as monotherapy or in combination, on the methacholine dose-response curve. This will allow~     for further elucidation of the mechanisms of each drug in human participants.~   "
46906|NCT02952911|"~     This prospective pilot study will assess the feasibility of remote participant monitoring~     using digital technology in participants with MS and healthy controls. At the enrollment~     visit, the participants as well as the healthy controls will be provided with a remote~     patient monitoring solution which includes preconfigured smartphone and smartwatch. The~     configured smartphone and smartwatch pair will contain application software that prompts the~     user to perform various assessments, referred to as active tests and passive monitoring.~     Active tests will include Hand Motor Function Test (HMFT), gait test, static balance test,~     electronic version of the Symbol Digit Modalities Test (eSDMT), Mood Scale Question (MSQ), MS~     Impact Scale (29-item scale) (MSIS-29) questionnaire, MS Symptom Tracking (MSST). Passive~     monitoring will be done to collect metrics on gait and mobility throughout the daily life of~     participants in a continuous and unobtrusive manner.~   "
47832|NCT02940821|"~     Assessing the effects of three oral care regimen on plaque, gingivitis, and tooth whitening:~     A randomized, person-centric, comparative effectiveness clinical research study by the~     Practitioners Engaged in Applied Research and Learning (PEARL) Network.~   "
46897|NCT02953028|"~     Obstructive sleep apnea (OSA) is a condition where the patient's breathing cease during sleep~     due to collapse of the oro-pharynx. The consequences are reduced quality of sleep, increased~     risk for developing cardiovascular disease and increased risk of accidents caused by daytime~     sleepiness. Among Norwegians 30-65 yrs, the prevalence of OSA are estimated to 16%. The~     golden standard in OSA-treatment is Continuous Positive Airway Pressure (CPAP). This is~     effective and must be used for life. However, CPAP-treatment might be uncomfortable for the~     patient, with poor compliance as a result. An alternative is Mandibular Advancing Splints~     (MAS), which is perceived as less troublesome and may initiate higher compliance. Through~     mapping of patient characteristics, the researchers investigate which patient-type benefits~     most from two different treatment-devices. The aim of the study is to assess how the MAS~     treatment differ from the CPAP treatment in respect to efficacy, compliance and impact on~     health related quality of life among patient diagnosed with mild/moderate OSA. All OSA~     patients referred to the Ear- Nose- Throat-department (ENT) at University Hospital,~     Northern-Norway (UNN) and St.Olavs Hospital were invited to participate in the study. The~     sample size at completion of the study should be 140 patients. Participants in the trial were~     randomly allocated to the two treatment groups, and assessed after 4 and 12 months of~     treatment. Data were collected through anamnesis, clinical examination, clinical photos,~     radiographs and questionnaires concerning general health related quality of life (SF36), oral~     health, cognitive aspects (HADS), sleep quality (PSQI), daytime sleepiness (Epworth's~     Sleepiness scale) and compliance.~   "
46898|NCT02953015|"~     Chronic migraine (CM) is a very disabling disorder with grave socioeconomic consequences.~     Pharmacological approaches can affect mechanisms of pain production, while rehabilitation~     such as Transcutaneous Electrical Nerve Stimulation and Manual Therapy may reduce the~     neuromuscular contributing factors. The main aim of the study is to evaluate the effects of~     cervical and thoracic manipulative techniques combined with OnabotulinumtoxinA prophylaxis on~     headache frequency in patients with Chronic Migraine (CM). The second aim is to evaluate the~     training effects on the intensity of headache attacks, analgesic consumption, cervical range~     of motion, TrPs sensitivity and disability. The hypothesis is that the manipulative treatment~     would alleviate CM symptoms and, in turn, decrease the analgesic consumption.~   "
46899|NCT02953002|"~     In total 200 subjects with diagnosis of sepsis, are planned for inclusion in this trial.~     After signing an informed consent a blood sample will be obtained from each participant. The~     investigators will measure the thrombin generation in plasma assessed by the calibrated~     automated thrombogram (CAT). Sequential Organ Failure Assessment score SOFA will be~     calculated. The relation between SOFA score and thrombin measurements will be determined.~   "
46900|NCT02952989|"~     This study is being done to find out the side effects (unwanted effects) that are caused in~     patients with cancers who are given SGN-2FF. This study will also attempt to find the most~     suitable dose in the disease or condition being studied and look at other effects of SGN2FF,~     including its effect on cancer.~      This study has several different parts. Part A will try to find the highest safe dose. Part B~     will enroll more patients to be treated at the highest safe dose or a lower dose to better~     understand how well SGN-2FF is tolerated. Part C will try to find the highest safe dose of~     SGN-2FF when it is given combined with pembrolizumab. Pembrolizumab is a standard treatment~     for cancer. Part D will enroll more patients to be treated at the highest safe dose of~     SGN-2FF combined with pembrolizumab or a lower dose of SGN-2FF to better understand how well~     SGN-2FF is tolerated when it is given with pembrolizumab.~   "
46901|NCT02952976|"~     This study is being done to compare two different Temporary Abdominal Closure methods that~     could be used in cases like yours. The methods being compared are the Barker's vacuum packing~     technique (BVPT) and the Open Abdomen Negative Pressure Therapy System (ABThera).~   "
46902|NCT02952963|"~     The purpose of this study is to examine the efffects of bile acid and bile acids sequestrants~     on GLP-1 secretion, in patients after Roux-en-Y gastric bypass.~   "
46903|NCT02952950|"~     In this project 3 studies examined two possible explanations and one possible preventive~     intervention to early cessation of exclusively breastfeeding in premature infants.~      Study 1 The content of protein in the milk of mothers, who delivers prematurely, is about a~     third higher than in the milk from the mother who delivers on time. The nutritional~     composition changes over time and the content of protein decrease. Therefore the premature~     infant is at risk of protein deficiency. While the infant is feeding by tube this decreasing~     content of protein can made up by adding, while it is more difficult when the infant is~     exclusively breastfeeding. The hypothesis is that reduced protein content in breast milk is~     associated to a fewer number of days where the premature infant is exclusively breastfed.~      Study 2 The premature infant is characterized with immature muscle with a low tension and~     therefore, a low ability to eat its needs by breastfeeding the first period. The transfer of~     milk from mother to child is an interaction between the mothers and her milk ejection reflex~     that establish a positive pressure on the milk and the child that have to establish a vacuum.~     The hypothesis is that the premature infants suction power is too weak to establish~     sufficient intraoral vacuum to ensure milk transfer from the breast to the infant and it can~     be related to a fewer number of days where the infant is exclusively breastfed.~      Study 3 The premature infants low muscle tone and its immaturity also influence on the~     organization and the quality of movements, marked as neuro motor processes. These processes~     form the oral motor base supporting movement which involves the infant ability to establish~     vacuum. The hypothesis is that Oral Stimulation for a specific program in 5 minutes before~     the minimum 2 meals per. day for at least 14 days increases the preterm infant's ability to~     create intra oral vacuum and thus the power to transfer milk from the breast, thereby~     extending the number of days when the infant is exclusively breastfed.~      200 infants are included consecutively, as a recurring cohort in all 3 studies. In Study 1~     the mothers' milk is analyzed in order to the content of protein. In Study 2 the infant~     suction is assessed by vacuum measurement. In study 3 the families are randomized to an~     intervention or control group and parents off 100 infants are guided by occupational~     therapists in a program of oral stimulation of their child.~   "
46904|NCT02952937|"~     The purpose of this clinical trial is to (1) evaluate the bioequivalence(BE) of GLA5PR~     GLARS-NF3 tablet 300mg administered regular diet relative to GLA5PR GLARS-NF1 tablet 300mg~     administered regular diet and (2) determine the safety and tolerability of a single dose of~     GLA5PR GLARS-NF3 tablet 300mg administered regular diet and GLA5PR GLARS-NF1 tablet 300mg~     administered regular diet.~   "
46905|NCT02952924|"~     This study is sponsor-open, investigator-blinded, participant-blinded, randomized,~     placebo-controlled, single-ascending dose (SAD) and multiple-ascending dose (MAD) study that~     will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of~     RO7049389 following oral administration in healthy volunteers and chronic HBV infected~     participants. The effect of food on the PK of RO7049389 and the effect of multiple dosing of~     RO7049389 on the PK of a single oral microdose of midazolam will be evaluated. The study will~     be conducted in two parts: Part 1 (1a [SAD cohort], 1b [Food-effect SAD cohort], 1c [MAD~     Cohort]) in healthy volunteers and Part 2 (Proof of mechanism [POM]) in chronic HBV infected~     participants.~   "
46907|NCT02952898|"~     This research study is being done to compare the safety and effectiveness of GDC 695 (test~     drug) against the currently marketed reference drug (diclofenac sodium gel, 3%) and to~     establish that these two drugs work better than placebo in the treatment of actinic~     keratosis.~   "
46908|NCT02952885|"~     Acromegaly is a rare, chronic, and debilitating disease, usually caused by a benign tumor on~     the pituitary gland, which leads to excessive production of growth hormone (GH). GH excess in~     turn causes overproduction of another hormone called insulin-like growth factor-1 (IGF-1).~     IGF-1 levels are currently the most widely accepted measure of disease activity.~      In Canada, medical therapy with a type of medicine called somatostatin analogues (SSA),~     such as octreotide and lanreotide, is recommended for treatment of acromegaly. However,~     studies have shown that a significant number of patients who take SSA medications alone~     remain with elevated levels of IGF-1 in their blood.~      Another medication that is used to treat acromegaly is pegvisomant (PEGV), and the~     investigators plan to study whether strict control of IGF-1, by adding or optimizing the use~     of PEGV, results in a significant health benefits to patients who still have modestly high~     levels of IGF-1 in their blood.~   "
46909|NCT02952872|"~     The project seeks to develop an effective computer-delivered brief intervention to reduce~     alcohol use using the Multiphase Optimization Strategy (MOST). Sixteen different versions of~     the intervention will be tested with manipulation of common factors (empathy & positive~     regard), use of a voice, and use of an animated narrator. Participants will include 352~     undergraduate students randomly assigned to one intervention condition; follow-up assessments~     will take place at one and 3 months. The main outcome will be means drink per day over the~     past 30 day.~   "
46910|NCT02952859|"~     Pancreatic cancer is the fourth leading cause of cancer deaths overall and second after colon~     and rectum cancer among gastrointestinal cancers in Western countries. In Switzerland, 1,172~     new pancreatic cancer patients were diagnosed in 2012. Unfortunately, only about 20% of~     pancreatic cancer patients present at a disease state that allows surgical resection while~     30% have locally advanced, unresectable disease and 50% show distant metastases. While the~     latter two are currently treated in a palliative setting with median survival of at most 6-12~     months, patients who undergo tumor resection with curative intentions also achieve only~     5-year survival rates of 20-25% in best hands. The reasons for this poor outcome are thought~     to be chemoresistance, early establishment of metastatic disease, and importantly, high rates~     of R1 resections. Up to 80% of pancreatic resections have positive resection margins which~     are often found within the vascular groove and/or at the retroperitoneal margin, close to the~     superior mesenteric artery. This high rate of positive margins is only found after meticulous~     pathological work-up and is normally not detected after standard assessment of the specimen.~     However, the clinical importance of the high positivity of resection margin is even more~     highlighted as patients undergoing portal vein resection despite negativity of portal vein~     invasion after regular pathological work-up show significantly better survival compared to~     patients without portal vein resection. In sum, given the overall poor prognosis despite~     tumor resection, auxiliary treatment strategies to improve long-term outcomes are desperately~     needed. Over the last 5 years, irreversible electroporation (IRE) emerged as a non-thermal~     ablative modality that allows local tumor destruction with sparing vital structures like~     arteries, venous vessels, as well as the bile and pancreatic duct. There is increasing~     evidence that IRE for locally unresectable pancreatic cancer is effective with an increase in~     local progression free survival , distant progression free survival and overall survival~     compared to historic controls.Data on margin accentuation IRE are sparse while in a recent~     study published by Martin et al showed that margin accentuation among patients with~     borderline resectable disease can be performed safe and efficacious if the treatment can be~     performed with a high degree of technical ability and skill set.~   "
46911|NCT02952846|"~     The study is a prospective interventional study with three main aims:~        1. Describe the frequency and severity of withdrawal syndrome in a population of paediatric~          intensive care patients.~        2. Test whether implementation of an algorithm for tapering of analgosedation changes the~          frequency and severity of withdrawal symptoms in the same population.~        3. Investigate how the health care providers experience having to adhere to such an~          algorithm.~   "
46912|NCT02952833|"~     This study is a study to evaluate the safety of ZPIV. Three dose levels may be evaluated. The~     entire duration of each subject's participation is approximately 14 months including~     recruitment and collection of data on the safety and reactogenicity of the study vaccine and~     samples for the assessment of immunogenicity. This study is expected to take approximately 30~     months to complete from initiation through availability of a final report on the primary~     outcomes of safety and the secondary outcomes of humoral immunity to ZIKV. The Primary~     objectives of this study are to 1. Assess the safety and reactogenicity of a homologous prime~     boost regimen of ZPIV given at three different dose levels and 2. Compare the safety and~     reactogenicity profile of ZPIV after each vaccination and between dosage groups.~   "
46913|NCT02952820|"~     The key objectives of this study are to determine, using sleep diaries, whether lemborexant~     at the doses 5 milligrams (mg) and 10 mg is superior to placebo on subjective sleep onset,~     subjective sleep efficiency, and subjective sleep maintenance in participants with insomnia~     disorder.~   "
46914|NCT02952807|"~     to compare between sequential and concurrent use of vaginal misopristol plus foleys catheter~     for induction of labor~   "
46915|NCT02952794|"~     To compare the treatment methods of endoscopic submucosal dissection (ESD) and endoscopic~     mucosal band ligation (EMBL) for early cancer.~   "
46916|NCT02952781|"~     The purpose of this research is to test the clinical value of a new P-wave sensitive~     recording vector compared to a standard ECG limb lead II vector from similar easy-to-use~     long-term cardiac rhythm monitoring patch systems, the Carnation TM Ambulatory Monitoring~     (CAM) System and the Zio-XT iRhythm. The P-wave is a critical aspect of the~     electrocardiogram. The purpose of this study is to see if the P-wave centric focus of the CAM~     system improves arrhythmia diagnosis.~   "
46917|NCT02952768|"~     Ultrasound is a frequently used diagnostic tool in the emergency department and suggested to~     have a role during resuscitation. The aims of this study were to develop a novel,~     resuscitative ultrasound-circulation-airway-breathing (US-C-A-B) protocol, to implement a~     short curriculum and to assess the feasibility.~      The US-C-A-B protocol was built in an advanced life support-compliant manner. It involved a~     3-part assessment: (1) C: subxiphoid 4-chamber view of the heart; (2) A: tracheal ultrasound;~     and (3) B: bilateral lung sliding. It could be used for direct confirmation for the C-A-B and~     searching the possible cause of cardiac arrest.~      A half-day curriculum was designed, and comprised of one-hour didactics and 3-hour~     small-group hand-on training. Assessments were performed, including a written test, the US~     image acquisition and a satisfaction survey. From August 1, 2014 to March 31, 2016, the~     multi-center emergency physicians who attended the US-C-A-B curricula were enrolled~     prospectively.~   "
46918|NCT02952755|"~     A randomized, open label, crossover study to explore drug-drug interactions between DWC20155~     / DWC20156 and DWC20162 in Healthy Volunteers~   "
47137|NCT02949908|"~     This is a prospective, multicenter, open label, uncontrolled, non-interventional, single arm~     study to measure treatment satisfaction of relapsing remitting MS (RRMS) subjects on Rebif~     after discontinuing initial first-line treatment.This study is a regional study with 3~     participating countries: Belgium, the Netherlands and Switzerland~   "
46919|NCT02952742|"~     This is a randomized, placebo-controlled crossover study. Participants will be actively~     participating in the study for 6 months, and enrolled in the study for up to 1 year. During~     the first phase of the study, the participants will be randomized into either the placebo~     group or treatment group for 8 weeks following 1 week of baseline data collection (no~     treatment). Following this first phase, a no-treatment washout period of at least 3 weeks~     will be implemented for all participants. After the washout period, the randomized groups~     will switch from treatment to placebo group, or placebo to treatment group for an additional~     8 week period. Hot flash frequency and severity will be documented using a daily hot flash~     diary and calculated using the Hot Flash Score questionnaire. The impact on quality of life~     will be documented by weekly Hot Flash Related Daily Interference Scale (HFRDIS)~     questionnaires.~   "
46920|NCT02952729|"~     This Phase 1b trial is an open label, multi-center study of XMT-1522 administered as an~     intravenous infusion once every three weeks. The dose escalation part of the study will~     establish the maximum tolerated dose or recommended Phase 2 dose for in patients with~     advanced breast cancer and either a HER2 immunohistochemistry (IHC) score of at least 1+~     using a validated IHC assay or with evidence of HER2 amplification. Patients with HER2~     positive (by IHC or amplification) gastric cancer or nonsmall cell lung cancer may also be~     eligible for participation in dose escalation. Upon completion of dose escalation, the cohort~     expansion segment of the study will consist of four parallel cohorts of different patients~     groups to confirm the maximum tolerated dose or the recommended Phase 2 dose and estimate the~     objective response in each of the patient populations.~   "
46921|NCT02952716|"~     The effects and safety of Human cord blood mononuclear cell for delayed encephalopathy after~     carbon monoxide poisoning~   "
46922|NCT02952703|"~     This study tests whether a smoking cessation intervention for pregnant women that extends~     postpartum (Striving to Quit (STQ)) can be implemented and disseminated outside of the~     research environment that established its effectiveness (40% maintained biochemically~     verified 6-month abstinence). The research aim is:~      Is Striving to Quit more effective in achieving postpartum smoking cessation than First~     Breath, the current standard of care for pregnant women in Wisconsin who smoke?~      250 women will be randomized into one of two study groups. Pregnant women in Group A (n=125)~     will receive the existing First Breath prenatal intervention. Those in Group B (Striving to~     Quit (STQ), n=125) will receive all Group A interventions, plus 1 additional prenatal home~     visit, 3 postpartum in-home smoking cessation counseling visits, 3 postpartum phone calls,~     and up to an additional $100 in gift cards. The primary outcome will be biochemically~     confirmed smoking cessation at 6-months postpartum.~   "
46923|NCT02952690|"~     The purpose of this study is to evaluate the feasibility of endotracheal intubation via~     glidescope videolaryngoscope (GVL) using different curve of stylet in 120 children aged~     between 1 and 5 year old.~   "
46924|NCT02952677|"~     This is a multi-centered randomized controlled trial to investigate the effects of~     Remind-to-Move (RTM) using wearable devices at home for promoting upper extremity recovery~     in stroke patients after discharge from subacute hospitals.~   "
46925|NCT02952664|"~     This study will employ two monitoring device prototypes. The devices are sensors containing~     accelerometers and gyroscope. The raw output data will be analyzed to determine when patients~     are moved or are repositioned in their beds. The data is captured within a modem which will~     correlate these movements with video recordings for interpretation by the research team. One~     sensor is wearable on the patient gown or sleepwear, and the other is placed underneath the~     frame of the hospital bed. The investigators propose a non-blinded trial with n=10 where all~     subjects will undergo the two devices. A video camera will be placed in each subject room for~     recording the repositioning events to correlate the monitor signals with the actual subject~     repositioning captured by the video. The goal of the trial is to validate the ability of each~     of the sensor prototypes to accurately detect when subjects are turned, in order to reduce~     stationary positioning which contributes to the incidence of pressure ulcers and to improve~     compliance with patient repositioning trials.~   "
46926|NCT02952651|"~     The purpose of this study is to evaluate predictability of a respiratory variation in pulse~     oximeter plethysmography for fluid responsiveness in children undergoing major surgery.~   "
46927|NCT02952638|"~     This study aims to test the hypothesis that dietary intake of phosphatidylcholine (PC) and~     lysophosphatidylcholine (LPC) acutely alters plasma lysophosphatidic acid (LPA) levels and~     autotaxin activity in normal weight and obese subjects.~   "
46928|NCT02952625|"~     This is a pilot non-intervention study that aims to introduce PET/MRI, a state of the art new~     imaging technique, into the radiotherapy treatment pathway of patients with head and neck~     cancer. Ultimately the investigators aim to establish appropriate scanning and image~     registration protocols, to allow progression to a randomized trial of adaptive radiotherapy~     dose escalation. The latter is thought to potentially improve outcomes in this group.~      Ten patients with squamous cell carcinoma (SCC) of the oropharynx, hypopharynx and larynx,~     planned for radical treatment with radiotherapy (+/-chemotherapy), will be recruited. Study~     participants will have two PET/MRI scans, with the radiotherapy immobilization devices in~     situ. The first will be done prior to the start of radiotherapy, the second half way through~     treatment.~      Image quality will be assessed by comparing to standard diagnostic scans and different~     registration methods will be compared to establish the best way of incorporating PET/MR image~     data into the radiotherapy planning system. Patient tolerability and workflow considerations~     will also be qualitatively assessed. Furthermore, a planning study will be conducted to~     establish relevant treatment protocols for a subsequent dose escalation trial.~      PET/MRI is an exciting new technology with a lot of potential in the context of adaptive~     radiotherapy dose escalation. Within this pilot study the investigators aim to address the~     technical challenges of using it in this context prior to proceeding to a randomized trial.~   "
46929|NCT02952612|"~     Papillary thyroid microcarcinoma are small thyroid cancer measuring 1cm or less. Most of this~     tumor are not palpable and are identified either through pathologic examination or from~     imaging modalities, such as CT scan or thyroid sono. Active surveillance of papillary~     microcarcinoma is to observe thyroid papillary cancer without immediate surgical approach.~     The purpose of this study is to understand more about the characteristics of papillary~     microcarcinoma, which has been known for the cancer slowly progression~   "
47138|NCT02949895|"~     A study to evaluate safety and tolerability of BMS-986012 in patients with small cell lung~     cancer~   "
46930|NCT02952599|"~     According to current guidelines, duration of anticoagulant treatment after a venous~     thromboembolic event varies from 3 months to indefinite treatment depending on the estimated~     risks of venous thromboembolism (VTE) recurrence and bleeding. Current data for edoxaban are~     limited to a maximum treatment duration of 12 months.~      Therefore, this study aims to gather further insight into efficacy (i.e. symptomatic~     recurrent VTE) and safety (i.e. bleeding events, liver adverse events, all-cause mortality~     and other drug related adverse events) of extended treatment with edoxaban up to 12 months in~     an unselected patient population in routine clinical practice.~   "
46931|NCT02952586|"~     This is a phase 3 randomized, placebo controlled study to evaluate the safety and anti-tumor~     activity of Avelumab in combination with standard of care chemoradiation (SoC CRT) versus SoC~     CRT alone in front-line treatment of patients with locally advanced head and neck cancer.~   "
46932|NCT02952573|"~     This is a phase 2 study to see how effective investigational drug, JNJ-42756493, is when~     given in combination with dexamethasone in two groups of patients with multiple myeloma~     (cancer of the plasma cells, a type of white blood cell present in bone marrow) that has~     relapsed (has come back after a period of improvement) or refractory (did not respond to~     standard treatment).~   "
46933|NCT02952560|"~     Difficulty in managing the airway is the single most important cause of major~     anesthesia-related morbidity and mortality. The currently used clinical method of predicting~     airway difficulty used by anesthetists is limited and not very highly sensitive or specific.~     Any additional bedside method that increases its specificity and sensitivity would be~     valuable. This project is designed to study and measure the tongue thickness and oral cavity~     height by using an ultrasound scan and comparing them with the same measurements obtained by~     CT scan. These will also be compared to a more complicated measurements used in previous~     studies to investigate any correlation with the currently used clinical methods. This~     information will help us decide if ultrasound may help Anesthesiologists assess difficulties~     in airway management in a more accurate, precise and reliable simpler method.~   "
46934|NCT02952547|"~     The purpose of this study to Compare the safety and pharmacokinetics between~     co-administration and fixed dose combination of DWC20155 and DWC20156 in healthy subjects~   "
46935|NCT02952534|"~     The purpose of this study is to determine how patients with metastatic castration-resistant~     prostate cancer, and evidence of a homologous recombination gene deficiency, respond to~     treatment with rucaparib.~   "
46936|NCT02952521|"~     This is a research study to look at differences in tumor tissue from ovarian cancer patients~     that may help to determine response and resistance to treatments.~   "
46937|NCT02952508|"~     This study evaluates CLR 131 in patients with select B-cell malignancies (multiple myeloma(~     MM), indolent chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL),~     lymphoplasmacytic lymphoma (LPL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL),~     and diffuse large B-cell lymphoma (DLBCL) who have been previously treated with standard~     therapy for their underlying malignancy.~   "
46938|NCT02952495|"~     This proposed Phase 2 The Small Business Innovation Research study is a randomized trial of~     the effectiveness of A Toast to Health in Later Life! a web-based patient educational~     program designed to prevent hazardous and harmful drinking in older adults. The project's~     specific objectives are to~        1. provide reliable information on the extent to which A Toast to Health in Later Life!~          reduces alcohol-related risks and problems among older patients who drink and~        2. evaluate the extent to which these reductions are associated with increases in~          health-related quality of life, patient knowledge and self-efficacy and decreases in the~          use of health services and the costs of care.~   "
46939|NCT02952482|"~     To test if the routine newborn screening dried blood spots can be used to test if elevation~     of C26:0 lysophosphatidylcholine (C26:0-lyso-PC), a status indicating adrenoleukodystrophy~     (ALD)~   "
46940|NCT02952469|"~     The purpose of this Radioactive Drug Research Committee (RDRC) study is to collect initial~     data regarding biodistribution, reproducibility, and dosimetry for the radiotracer Ga-68~     PSMA-HBED-CC, an agent which may be useful for the early detection of metastatic prostate~     cancer. Investigators will use a test and re-test design in all patients to determine~     reproducibility of lesion detection and signal intensity, and will include dynamic imaging in~     some patients for the purposes of dosimetry. Patients with known metastatic prostate cancer~     will be recruited and imaged on two occasions within the course of 15 days.~   "
46941|NCT02952456|"~     Rationale : Persons with epilepsy have a greater risk of incurring accidental injury and a~     higher mortality risk than the general population.~      The main objective of the study is to understand life experience of the disease or risks~     associated with epilepsy in patients with epilepsy, relatives of patients and bereaved~     families.~      Study design: Qualitative study (study based on interviews) Population: Three groups will be~     interviewed: bereaved families, patients with epilepsy and relatives of patient. Bereaved~     family: relatives who contact the French sentinel network Réseau Sentinelle Mortalité~     Epilepsie (RSME) notifying an epilepsy-related death (regardless the cause of the death and~     the timeframe between death and interview). Patients with epilepsy: patients having a secure~     diagnostic of epilepsy from 15 years old to 65 years old. Relatives of patients with~     epilepsy: spouse/husband or parents invited by a patient with epilepsy to participate to the~     interview who consent to participate.~      Method: Semi structured in-depth interviews will be conducted by an experienced qualitative~     psychologist in face to face, at home, at the hospital or at any other place (depending on~     the choice of the participants). The interview topic guide will be centered on~     participants'personal experience. Interviews will be digitally recorded and will be~     transcribed by a secretary.~      The results of this study will be integrated in educational therapeutic programs regarding~     prevention of risks related to epilepsy.~   "
46980|NCT02951949|"~     One hundred Spanish postmenopausal women accepted to be investigated for cardiovascular risk~     actors including clinical features, serum biochemical parameters, single nucleotide~     polymorphisms for estrogen receptor, and imaging parameters, carotid intima-media thickness~     (92 women) and coronary computed tomography (32 women). MANOVA analysis confirmed that both~     age and estradiol level behaved as independent variables associated with IMT. Findings at the~     coronary arteries, either moderate or high calcium index (CAC) and/or significant lumen~     stenosis were sporadic and did not allow for establishing association with any of the~     variables assessed.~   "
46942|NCT02952443|"~     The objective of this study is to evaluate a multi-component exercise intervention as an~     effective therapy to reverse pre-frailty phenotype in females age 65 or older. Participants~     will be screened for frailty phenotype using the Cardiac Health Study - Frailty Index (CHS);~     the Clinical Frailty Scale (CFS); and a measure of self-paced normal walking speed.~     Participants undergo baseline evaluation to determine frailty phenotype and then those~     females who meet the pre-frailty criteria are randomized into one of two groups; 1)~     Multi-component exercise program, or 2) A control group who receives a monthly newsletter on~     tips for successful aging. The exercise group will participate in multi-component exercise~     program which will emphasize resistance training but also include aerobic, balance and~     flexibility components 3 times a week at 45 to 60 minutes/session for 16 consecutive weeks.~     The control group will be asked to maintain normal daily-living habits for the duration of~     the 16-week study.~   "
46943|NCT02952430|"~     Patients aged over 65 comprise more than half the emergency general surgical workload,~     however, available risk-prediction tools for such patients are extrapolated from younger~     cohorts. Research suggests that high pre-operative frailty scores correlate with increased~     post-operative mortality and morbidity. Validated frailty assessments may help identify high~     risk older emergency surgical patients, facilitating decision-making and informing patient~     choice.~      We propose the first prospective UK observational study assessing frailty as an independent~     predictor of outcome in the older surgical patient undergoing emergency laparotomy.~      Prospective data collection of patients over 65 undergoing emergency laparotomy will be~     performed in 20 NHS Trusts. Pre-operative frailty scores will be evaluated using the Rockwood~     Frailty Scale. Primary outcome measure is 30-day mortality. Secondary outcome measures are~     post-operative complications, altered independence status and length of stay.~      Results will be disseminated at national/international surgical meetings and published in a~     peer-reviewed journal.~   "
46944|NCT02952417|"~     The aim of this study was to estimate the impact of sex on relative survival and excess~     mortality following acute myocardial infarction (AMI) using a population-based cohort within~     a relative survival framework. Patient-level data concerning demographics, co-morbidity,~     cardiovascular risk factors and treatments at discharge were extracted from the Swedish~     Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated~     According to Recommended Therapies (SWEDEHEART), a population-based registry of outcomes for~     patients hospitalized with acute coronary syndrome. Patients were followed-up for their vital~     status after AMI hospitalisation, with censoring at the end of follow-up on the 31st of~     December, 2013.~   "
46945|NCT02952404|"~     This is a retrospective cohort study. This two cohort study seeks to compare the incidence of~     obstetric anal sphincter injuries (OASIS) in two time periods, before and after an~     educational workshop for improved perineal support.~   "
46946|NCT02952391|"~     Although PD is considered predominantly as a motor disease caused by loss of dopaminergic~     neurons, multiple studies indicate that cholinergic dysfunction already starts in early PD~     and is crucial for the development of dementia in addition to motor symptoms.Because of its~     crucial role in CNS functioning and neurodegenerative disorders, including PD, it is of great~     importance to get a better understanding of the cholinergic functioning in the brain.~     Pathways of acetylcholine synthesis, transport and release provide possible targets for in~     vivo imaging of the cholinergic system. However,previous approaches are considered as~     indirect biomarkers of cholinergic terminal integrity because they measure both pre- and~     post-synaptic expressions. The novel vesicular acetylcholine transporter (VAChT) tracer~     [18F]Fluoroethoxy-Benzovesamicol ([18F]FEOBV) provides a more direct measurement of~     presynaptic cholinergic function. The use of [18F]FEOBV as a Positron Emission Tomography~     (PET) imaging marker of cholinergic innervations has, however, only been studied in healthy~     human volunteers and no data is available on patients.~      With this study the differences in cholinergic function between PD patients and healthy~     aged-matched volunteers will be quantified. In addition the test-retest variability will be~     determined~   "
46947|NCT02952378|"~     Treatment with colloidal solutions has during long time been a cornerstone within intensive~     care. Lately, doubts have been raised about synthetic colloids, and the natural albumin has~     been used more and more.~      One of these solutions is the hyperoncotic Albumin 20%. However there are still many~     aspects of the physiological effects of hyperoncotic albumin, that are not known. In this~     study physiological effects will be studied in burn patients and healthy subjects. The~     colloid osmotic pressure and the increase of the plasma volume will be measured in 15 healthy~     subjects and in 15 burn patients. The effect on the plasma volume will be studied using~     hemoglobin as a marker of dilution. Colloids osmotic pressure and albumin concentration will~     be measured directly and urin production will also be measured. Blood samples will be~     collected during 4 to 5 hours to achieve a profile over the changes.~   "
46948|NCT02952365|"~     The purpose of the study is to evaluate the use of prophylactic tissue sealant to prevent~     epithelial ingrowth from gaining access under a LASIK flap with repeat LASIK surgery~   "
46949|NCT02952352|"~     To reduce modifiable diabetes risk factors' in overweight and obese AI men residing on the~     Colville reservation through a community-based, culturally informed intervention, the study~     specifically aims to: 1. conduct focus groups and interviews with adult members of Colville~     tribe to inform the adaptation, manualization and implementation of a culturally informed~     diabetes prevention program among overweight and obese AI men; 2. evaluate the effectiveness~     of a community-based, culturally informed diabetes prevention intervention by assessing~     between group changes.~   "
46950|NCT02952339|"~     The purpose of this study is to evaluate the safety, infectivity, and immunogenicity of a~     single dose of a recombinant live-attenuated respiratory syncytial virus (RSV) vaccine in~     RSV-seronegative infants 6 to 24 months of age.~      This study is a companion study to IMPAACT 2011.~   "
46951|NCT02952326|"~     Comparing the postoperative flare ups and pain after adding the XP Endo Finisher to the final~     irrigation protocol on necrotic mandibular premolars.~   "
46952|NCT02952313|"~     This study is being conducted to obtain outcomes data in subjects with severe to extreme~     class NOSE scores undergoing placement of the Spirox Latera Implant with or without~     concurrent septoplasty and/or turbinate reduction procedures in an operating room setting.~   "
46953|NCT02952300|"~     the aim in this prospective in vivo randomized clinical trial to evaluate the influence of~     instrumentation technique ( reciprocation single file (wave one ) versus rotation single file~     (neolix) ) on post operative pain ( incidence ,degree and duration ) after endodontic~     treatment in single rooted lower premolars with symptomatic irreversible pulpits.~      According to the inclusion criteria the patients enrolled in the study and allocated randomly~     into two groups either Wave One (group A) or Neolix ( group B) the endodontic treatment is~     done at single visit. firstly the patient's medical and dental history is taken .the patient~     assign on informed consent. and then,anaesthetized and access cavity performed and root canal~     preparation is done by either two systems and then irrigation and obturation is done. the~     patient record the post operative pain in sheet with NRS after 6,12,24,48hr and the operator~     will recall the patient to check the records and follow up the patient.~   "
46954|NCT02952287|"~     The purpose of our study is to validate the accuracy of 4D PC flow method in quantification~     of thoracic and upper abdominal blood flow volumes in children. In this validation study, 4D~     PC flow method will be applied in 100 pediatric patients undergoing clinically indicated CMR~     with 2D PC flow measurement.~   "
46955|NCT02952274|"~     The aim of this study is to compare the ball attachment to the locator attachment regarding~     the OHRQoL (oral health related quality of life) for completely edentulous patients retaining~     a mandibular overdenture with a midline placed implant~   "
46956|NCT02952261|"~     The purpose of this study is to explore the effectiveness of 3D printing in small pulmonary~     nodule localization by the design of an assisted device to facilitate the localization~     procedure.~   "
46957|NCT02952248|"~     The main objective of the dose-escalation part of the trial is to determine the safety and~     tolerability, and to determine the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose~     (RP2D) of BI 754091 on the basis of patients with dose-limiting toxicities (DLTs) in patients~     with selected advanced solid malignancies. Safety and tolerability will be evaluated by~     monitoring the occurrence of adverse events (AEs), serious AEs (SAE), and laboratory~     parameter abnormalities, as well as changes to vital signs.~      Secondary objectives are the determination of the PK profile of BI 754091 after single and~     multiple doses of BI 754091, and the preliminary assessment of antitumour activity.~      In the dose-expansion part of the trial, the main objectives are to further assess the~     safety, efficacy, PK profile, and biomarkers of BI 754091in tumours with specific tumour~     types and/or genetic mutations at the RP2D.~   "
46958|NCT02952235|"~     Use of two high SPF sunscreens under actual use conditions.~   "
46959|NCT02952222|"~     The primary aim of this study is to compare the propofol requirements of children who receive~     propofol with that of children who receive dexmedetomidine prior to propofol, for sedation~     for upper and lower endoscopic procedures.~   "
46960|NCT02952209|"~     This study is designed to assess the effects of Alveolar Ridge Preservation (ARP) after tooth~     extraction compared to extraction alone in the posterior maxilla. The results of this study~     will demonstrate if the use of ARP reduces alveolar ridge resorption at 6 months post~     extraction in the posterior maxilla region.~   "
46961|NCT02952196|"~     Addiction to amphetamine is characterized by alternating phases of intoxication and short~     abstinence, followed by recurrent drug-craving episodes which result in distress and relapse.~     Addiction involves a number of neurotransmission systems, including the endocannabinoid~     system (ECBS). It has been demonstarted that cannabidioids can have physiological, anxiolytic~     and neuroprotective properties. It has been shown to have multiple therapeutic properties for~     treating anxiety, schizophrenia and interestingly cannabinoids have been shown to be~     potentially helpful in treating addiction, due to their effects on various neuronal circuits~     involved in this disorder.~      The investigators overall hypothesis is that cannabinoids are an interesting pharmacological~     contender to decrease amphetamine craving and treat amphetamine addiction.~   "
46962|NCT02952183|"~     Although nerve-sparing surgery has been introduced for female patients with the pelvic~     tumors, its success rate depends on operators. To achieve consistency of surgical procedure,~     It is necessary to adopt pelvic autonomic nerve monitoring technique.~      The Aims of this study is~        1. Development of pelvic autonomic nerve monitoring system (PAMS I) by using urodynamic~          system.~        2. Evaluation of autonomic nerve sparing by intraoperative monitoring with PAMS I~        3. Evaluating the efficacy of PAMS I by intraoperative neurophysiological monitoring (IOM)~   "
46963|NCT02952170|"~     This study will assess the impact of weight loss surgery (WLS) on non-alcoholic fatty liver~     disease (NAFLD) in adolescents as well as the interaction between NAFLD and cardiometabolic~     risk.~   "
46964|NCT02952157|"~     Postoperative sore throat is a complication after general anesthesia requiring endotracheal~     intubation. The investigators will evaluate the efficacy of lidocaine jelly application on~     the endotracheal tube with taper-shaped cuff regarding postoperative sore throat.~   "
46965|NCT02952144|"~     Dialysis-related amyloidosis (DRA) is a serious complication of long-term hemodialysis (HD).~     Its pathogenic mechanism involves accumulation of β2-microglobulin (β2M) in the blood. β2M is~     produced by most cells in the body and is metabolized in the kidney in healthy individuals.~     However, in HD patients with renal dysfunction, β2M which is not removed entirely by HD~     accumulates excessively in the blood. Then it forms amyloid fibrils that are deposited in~     bones, joints, and soft tissues. The fibrils are further modified by advanced glycation end~     products (AGE), inducing local macrophage infiltration and production of cytokines leading to~     chronic inflammation and activation of osteoclasts. Consequently, severe complications with~     various symptoms are developed, which are collectively referred to as DRA.~      Lixelle® is a whole-blood β2M apheresis column developed to adsorb and eliminate β2M~     selectively from the blood of DRA patients. The treatment is performed with Lixelle®~     connected upstream of the dialyzer in series on a HD circuit in every session. The Lixelle®~     column contains porous cellulose beads with covalently linked hexadecyl alkyl chain ligands,~     which selectively adsorb β2M, via a molecular sieving effect because of its porous structure~     and hydrophobic interaction with ligands. Lixelle® has been used to relieve symptoms and~     prevent the progression of DRA in Japan since 1996, when health insurance coverage and~     reimbursement for the treatment were approved by Japanese Ministry of Health, Labor, and~     Welfare. Improvement of the activities of daily living (ADL) and remission of arthralgia by~     Lixelle® treatment has been shown in several clinical studies.~   "
46966|NCT02952131|"~     Inflammatory Bowel Disease (IBD) is a group of inflammatory conditions of the small bowel and~     colon. Main types include Ulcerative Colitis and Crohn's Disease. Symptoms are often~     difficult to distinguish except for location and nature of changes. IBD complex arises with~     interaction of environmental, genetic factors, immunological responses, and chronic and~     recurring inflammation.~      Many factor appear as contributory, but no single set of issues appear to explain the~     process. Microbiota, intestinal wall granulation or breach, dietary, genetic predisposition~     all appear to factors. Treatment is often reactive or suppressive medications, neither of~     which appears to reverse the disease processes. This study explores the value of a complex~     group of adipose-derived stem/stromal cells (AD-cSVF) in the disease process.~   "
46967|NCT02952118|"~     This is an open, pilot study for adults ( age range of 20-70 years old), who suffer from~     snoring without obstructive sleep apnea (OSA) and no need for CPAP treatment: with standard~     diagnosis of sleep study or with minor sleep disorder (AHI of less than 15 events per hour).~     Patients with no OSA over the last year will sign an informed consent after receiving~     explanations from authorized physician (Professor Asher Tal). The patient will than undergo a~     sleep study using a mobile device PAT (Peripheral Arterial Tomography, Itamar Medical,~     Israel) ,an approved device in Israel, USA and many other European countries,, approved for~     use by the USA FDA). This sleep study is needed in order to rule out OSA, namely AHI of more~     than 15 events per hour of sleep.~      The study duration with each patient will be 48 hours (two nights); at the first night the~     sleep study will be with PAT device, with snoring recording and without the Forrest epic~     device. In the second night the sleep study will be with PAT device, with snoring recording~     and with the Forrest epic device. The order of the sleep studies (with and without the epic~     device) will be randomly determined by computerized ahead prepared list. The research~     duration for patients that did not have a sleep study over the last year, will take place for~     3 nights; the sleep study will be performed in order to make sure the patient does not suffer~     from obstructive respiratory disorder during sleep. The sleep studies will take place in a~     sleep laboratory (Millennium Sleep Labs LTD, Beer Sheva) or as an ambulatory study, at home.~      Recordings over the nights with or without the Forrest epic device will be carried out at~     the patient's home, after verification that each patient sleeps alone in his/her room. The~     recording and data processing of snoring will be performed through the application SNORLAB~     on IPHONE 6 mobile device. Ambulatory sleep studies with PAT device will be carried out~     during two nights (with and without the Forrest Device) with most patients.~      During the examination, respiratory index will be tested such as: obstructive respiratory~     events during sleep, oxygen saturation in blood at rest (measured non-invasively) during~     sleep: mean, lowest (nadir), and rate of time the patient sleeps in with less than 90% of~     oxygen saturation in blood.~   "
46968|NCT02952105|"~     It's so important to recognize ventricular fibrillation in cardiac arrest and defibrillation~     early. At the same time Research findings have identified high-quality CPR with minimum~     interruption is critical to the success of defibrillation therapy. Both the guidelines by~     American Heart Association and the guidelines by European Resuscitation Council emphasize the~     importance of minimizing interruptions in chest compressions, specifically, duration of the~     pre-shock and post-shock pauses. So AHA indicate that there will be a new algorithm of VF~     during chest compression, which has high sensitivity and specificity. And the investigators~     can identify VF and defibrillate earlier.~      The aim of this study is to verify that if Sherlock algorithm of Philips MRx~     monitor/defibrillator can identify shockable rhythms during chest compression accurately.~   "
46969|NCT02952092|"~     The objective of this study is to evaluate the safety and efficacy of ASP1517 compared to~     darbepoetin alfa in hemodialysis chronic kidney disease patients with anemia.~   "
46970|NCT02952079|"~     The goal of this study is to compare which treatment - BlephEx or MiBoFlo - will be a better~     option for patients suffering from dry eye secondary to Meibomian Gland dysfunction.~   "
46971|NCT02952066|"~     The purpose of this study is to measure the density of a temperature-sensitive protein, named~     TRPV1, in the airway mucosa tissue of both non-asthmatic and moderate to severe persistent~     asthmatic patients. This study may generate information for developing new therapeutic~     strategy.~   "
46972|NCT02952053|"~     The main objective of this study is to assess effects of Dry Needling into Myofascial Trigger~     Point compared Dry Needling into Taut Band point based on the outcomes of myotnometric~     measurement in healthy subjects.~      Hypothesis: Deep Dry Needling of the latent medial Myofascial Trigger Point (MTrP) of the~     soleus muscle will achieve changes in myotonometric measures compared to Deep Dry Needling of~     the Taut Band of the soleus muscle.~   "
46973|NCT02952040|"~     The objective of this study is to evaluate the effect of lanthanum carbonate hydrate on the~     pharmacokinetics (PK) of ASP1517 in non-elderly healthy male subjects.~   "
46974|NCT02952027|"~     Post-operative pulmonary complications (PPCs) have a major impact on patients and healthcare~     expenses. The goal of perioperative respiratory therapy is to improve airway clearance,~     increase lung volume, and mitigate atelectasis. Incentive spirometers (IS) are ubiquitously~     used to prevent atelectasis and PPCs—implementation of which requires substantial provider~     time and healthcare expenses. However, meta-analyses have demonstrated that the effectiveness~     of ISs is unclear due to poor patient compliance in past studies.~      The goal of this investigation is evaluate the effectiveness of IS on post-operative clinical~     outcomes. The aims of this investigation are to evaluate 1) if IS use compliance can be~     improved by adding a use-recording patient reminder alarm, and 2) the clinical outcomes of~     the more compliant IS users vs. the less-compliant IS users.~   "
46975|NCT02952014|"~     The purpose of this study is to examine the acute effects of a pre-workout dietary supplement~     on energy metabolism, cardiovascular hemodynamics, blood metabolites and mental focus.~   "
46976|NCT02952001|"~     The purpose of this study is to characterize the continued clinical benefit(s) regarding~     safety and efficacy of suprachoroidally administered CLS-TA, triamcinolone acetonide~     injectable suspension, for the treatment of macular edema associated with non-infectious~     uveitis. This study will be a non-interventional extension of the Parent study, CLS1001-301.~   "
46977|NCT02951988|"~     This study will evaluate the efficacy, safety and tolerability of rapastinel 450 milligrams~     (mg) intravenous (IV) once weekly or once every 2 weeks versus placebo as an adjunctive~     treatment to ongoing anti-depressive therapy (ADT) in the prevention of relapse in~     participants with Major Depressive Disorder (MDD).~   "
46978|NCT02951975|"~     This observational study will evaluate the safety, efficacy, characteristics of patients,~     characteristics of physicians and quality of life in patients who are prescribed OZURDEX® as~     treatment for non-infectious uveitis of the posterior segment of the eye in France.~   "
46979|NCT02951962|"~     This is a phase 1, open label, two-cohort, single-sequence, crossover study~   "
46981|NCT02951936|"~     Chronically ventilated patients will be hemodynamically measured by bioimpedance (NiCAS by NI~     medical ltd.) for cardiac output, Total peripheral resistance and other NICAS derived~     parameters.~      Patients fluid balance will be planned according to these parameters and the rate of~     liberation from ventilator and rate of worsening renal function will be measured~   "
46982|NCT02951923|"~     Bovine colostrum is the milk produced by cows immediately after calving. It contains high~     levels of proteins that improve immune protection and may act to prevent colds. During~     intense training, athletes often have compromised immune function. This may be especially~     true in club-level rugby players who abruptly start high intensity training in the spring in~     preparation for their competitive season. Our study will assess the effects of supplementing~     these players with bovine colostrum during this intense training. Thirty-six players will be~     recruited; half will consume colostrum during the 8 weeks of early-season training and half~     soy protein. The investigators predict the bovine colostrum supplement will improve health~     during the training and increase fitness levels.~   "
46983|NCT02951910|"~     Hyaluronic acid, a natural polymer, helps to maintain ocular surface hydration and can~     already be found in several artificial tears recommended to alleviate symptoms of dry eye. A~     recent hyaluronate modification involves zinc-hyaluronate complex formation by adding~     zinc-chloride to an aqueous sodium-hyaluronate resulting in a very stable molecular~     structure, which functions as both a mechanical barrier and a biocompatible film on the~     ocular surface. Apart from its beneficial elastoviscous characteristics, previous results~     indicate that hyaluronate can also reduce the excitability of the peripheral nociceptor~     endings underlying pain. Although hyaluronate is widely used in artificial tears to improve~     tear film stability, its effect on ocular surface sensitivity was not evaluated in patients~     with dry eye. The aim of this study is to investigate the characteristics of ocular surface~     sensations and corneal sensitivity in dry eye patients before and after long-term tear~     supplementation with zinc-hyaluronate.~   "
46984|NCT02951897|"~     In 2015-2016, 224,390 cases were newly diagnosed with lung cancer in USA. Of all the cases,~     83% are non-small cell lung cancer (NSCLC). Currently, the 5-year survival rate of NSCLC~     patients is 21%, and more than 25% of early stage NSCLC patients, who have undergone surgical~     treatment, will have a relapse or progression.~      Circulating tumor cells (CTCs), which shed from the primary tumor into the vasculature or~     lymphatics, can be regarded as a new prognostic factors of metastatic process. Thus far,~     CTCs-detection technologies can be divided into epithelial cell adhesion molecule~     (EpCAM)-based detection methods, e.g., the widely used CellSearch® and Adnatest®,and~     EpCAM-independent detection methods, e.g., ISET® and ScreenCell®. Herein, the investigators~     used a newly established approach, i.e., CanPatrolTM to detect CTCs in early stage lung~     Adenocarcinoma cases.~      The investigator aim to explore whether CTCs detection prior to surgery can be contributive~     to the early diagnosis, or may help to predict the prognosis and guide the treatment strategy~     of early stage lung Adenocarcinoma.~   "
46985|NCT02951884|"~     This study will evaluate pain level experienced by patients who have a break of the top of~     their shinbone and have either blood removed from the joint alone or have blood removed and~     medicine injected into the joint.~   "
46986|NCT02951871|"~     Background.Although the life expectancy of patients with FL has recently increased, notably~     since the introduction of rituximab in combination with chemotherapy, little is known~     regarding the precise causes of patients death. Patients and methods'. This study describes~     the different causes of death in FL patients among followed since 2000 at Lyon University~     Hospital, centre Léon Bérard and Mayo Clinic. The causes of death will be classified as~     related to lymphoma progression, treatment-related toxicity (including TRM and secondary~     myelodysplastic syndrome/acute myeloid leukemia), secondary neoplasias, or other.~   "
46987|NCT02951858|"~     The purpose of this research is to improve the ability of primary medical staffs in screening~     and intervention for alcohol, benzodiazepines, and other illicit drug use.~   "
46988|NCT02951845|"~     The purpose of the study is to assess the oral bioavailability of the two tablet formulations~     of JNJ-54416076 relative to the suspension formulation and to investigate the effect of a~     high fat meal on the pharmacokinetics of the tablet formulation in healthy participants.~   "
46989|NCT02951832|"~     The investigators are going to select the normal child-bearing period women as the study~     subjects and draw their peripheral blood to observe and analyze the change of quantity and~     percentage of lymphocyte subsets along with the change of menstrual cycle.~      Recording their BMI\menstrual history\and childbearing history, the investigators would~     select 300 healthy women in 6 different age groups which are aged 20-24, aged 25-29, aged~     30-34, aged35-39, aged 40-44 and aged 45-49, then draw 1-2 ml blood form their peripheral~     vein (adding EDTA for anti-coagulation). The investigators are going to perform routine~     examination on the blood samples and detect T\B\NK lymphocyte through flow cytometry (FCM),~     thus calculating the absolute number of every species of lymphocyte. The investigators make~     assessment for the cellular immune function of the women during child-bearing period via~     comparing distinction in percentage and absolute number of every lymphocyte subset among~     reproductive-age women in different ages.~   "
46990|NCT02951819|"~     The purpose of this study is to evaluate complete response plus (+) very good partial~     response (CR+VGPR) rate following 4 cycles of induction therapy of daratumumab in combination~     with cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD), in previously untreated~     subjects, and in relapsed subjects with multiple myeloma, as defined by the International~     Myeloma Working Group (IMWG) criteria.~   "
46991|NCT02951806|"~     Pruritus is a troublesome side-effect of neuraxial (epidural and intrathecal) opioids.~     Sometimes it may be more unpleasant than pain itself. The incidence of pruritus is 83% in~     postpartum patients and 69% in non-pregnant patients including males and females (1). Some~     researchers concluded that slow injection rate of hyperbaric bupivacaine may be a simple and~     effective way to reduce the incidence and severity of hypotension during cesarean section~     under spinal anesthesia (2). In this new research I want to investigate the effect of slow~     injection of fentanyl separately, in spinal anesthesia for cesarean section, on the incidence~     of itching In this double blind randomized study two hundred parturient will be randomly~     allocated in to two groups; Group (R) will receive 25 mic fentanyl spinal ( after dilution~     with 2.5 ml CSF) in 15 seconds. Group (S) will receive the same dose in 90 seconds All~     parturient will receive 10 mg bupivacaine in 45 min after fentanyl. Exclusion criteria will~     be those with allergy to any medications, contraindications to spinal anesthesia, those who~     requested sedation, presence of skin lesions that may cause itching and opioid addiction.~      Parturient will be monitored regarding the incidence of itching, hypotension, nausea and~     vomiting. Onset and level of sensory block will also be recorded.~   "
46992|NCT02951793|"~     Investigators are seeking to determine the impact of recent alcohol, smoking or psychotropic~     drug use prior to intensive care unit (ICU) admission on incidence of delirium and sedation~     requirements.~      Study design: A prospective observational study, in a medical ICU of a tertiary university~     hospital.~      Methods: For all new ICU admissions, a 1-page questionnaire including Alcohol Use Disorders~     Identification Test (AUDIT-C), smoking history and prior medication use was given to the~     patient or closest family members.~      Delirium was assessed by trained ICU nurses using Intensive Care Delirium Screening Checklist~     and Richmond Agitation-Sedation Scale.~   "
46993|NCT02951780|"~     The purpose of this study is to determine how the body handles LY3185643 and rGlucagon and~     what effects LY3185643 and rGlucagon have on the body. This study will also help to determine~     if LY3185643 is safe and well-tolerated.~      This study will last at least 35 days, not including screening.~   "
46994|NCT02951767|"~     This Phase II, single-arm study is designed to evaluate the effect of atezolizumab treatment~     in participants with locally advanced or metastatic urothelial bladder cancer. Participants~     will be enrolled into 1 of 2 cohorts. Cohort 1 (reported here) will consist of participants~     who are treatment-naïve and ineligible for cisplatin-containing chemotherapy. Cohort 2 will~     contain participants who have progressed during or following a prior platinum-based~     chemotherapy regimen. The results of the second cohort are reported separately (NCT02108652).~     Participants in both cohorts will be given a 1200 milligrams (mg) intravenous (IV) dose of~     atezolizumab on Day 1 of 21-day cycles. Treatment of participants in Cohort 1 will continue~     until disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1~     (RECIST v1.1) or unmanageable toxicity. Treatment of participants in Cohort 2 will continue~     until loss of clinical benefit or unmanageable toxicity.~   "
46995|NCT02951754|"~     Methylphenidate (MPH) is the first-line pharmacological treatment for adults with~     Attention-Deficit/Hyperactivity Disorder (ADHD). Nevertheless, there is considerable~     interindividual variability regarding the dose required, tolerability and response rates to~     MPH. The aim of this study is to address the clinical and genetic predictors of MPH treatment~     outcomes in ADHD.~   "
46996|NCT02951741|"~     Revision total hip replacement arthroplasty is a surgery having intra- and postoperative~     substantial blood loss. The investigators will investigate the relationship between the~     various hematologic variables and postoperative bleeding volume.~   "
46997|NCT02951728|"~     This is a Phase I/II Trial of Decitabine + R-CHOP in Diffuse Large B-Cell Lymphoma~   "
46998|NCT02951715|"~     Twenty patients with tinnitus and a typical noise-induced hearing loss (NIHL) audiogram were~     included. Each subject underwent an otoscopic examination, distortion product otoacoustic~     emissions, tinnitus-match testing, Tinnitus Handicap Inventory (THI) and serum zinc level~     analyses. After 2 months of treatment with zinc, all tests were repeated.~   "
46999|NCT02951702|"~     The purpose of this study is to determine if oral vancomycin used as primary Clostridium~     difficile prophylaxis can reduce the incidence of this infection in high-risk patients.~   "
47000|NCT02951689|"~     Purpose: To evaluate the influence of probiotic supplementation on body composition and other~     markers of health in occupational shift-workers.~      Participants: Healthy, overweight females (ages 22-55 yrs) who are employed on a~     shift-working schedule.~      Procedures (methods): In a randomized, placebo-controlled intervention, subjects will~     complete 3 different testing sessions (pre-screening, 1 baseline, 1 post-testing session) as~     well as a 6-week intervention period. Prescreening will include written informed consent, a~     health history questionnaire, baseline anthropometric measures, assessment of resting heart~     rate, and exercise protocol familiarization. Baseline testing will involve body composition,~     a fasted blood draw, mood surveys, and an exercise treadmill test. Subjects will be~     randomized to a treatment group (multi-strain probiotic or placebo) for 6 weeks of~     supplementation that includes 2 electronic contacts, followed by post-testing that will occur~     in the same fashion as baseline testing.~   "
47001|NCT02951676|"~     This is a prospective, longitudinal, observational, cohort study investigating young adults~     undergoing surgical extraction of a wisdom tooth with and without antibiotics~     post-operatively. The prescription of antibiotics will be based on clinical judgment based on~     case complexity, trauma and length of procedure. No randomization will be performed. Saliva~     will be collected at seven observational time points ( Baseline, one week ,two weeks, three~     weeks , one month,three months and six months.) and Supragingival plaque samples will be~     collected at four observational time points ( Baseline , one week , one month, and 3 months)~     .A control group of 15 subjects who do not undergo dental extractions or antibiotic treatment~     will be recruited after obtaining informed consent and will be followed up for the same seven~     time points..Routine standard care will be observed. No new medications are triedThe samples~     will be analysed for identification of bacterial genes using 16 S r RNA gene sequecing and~     QPCR for change in the antibiotic resistance genes overtime. Kindly note that in the current~     study the participants are patients who are already scheduled to undergo tooth extractions~     with or without antibiotic treatment based on clinical judgement by the clinician performing~     the extraction. ( These patients are on the waiting list for third molar extractions in the~     dental hospital concerned.)~      The participants will receive the intervention( Third molar extraction with /without~     antibiotics) in the same manner and intensity even if they are not enrolled for the study.~   "
47023|NCT02951390|"~     Adenomas in Lynch syndrome have an accelerated progression to colorectal cancer (CRC) which~     might occur despite a regular follow-up. Despite low evidence, high-definition technology~     (HD) and indigo-carmine chromoendoscopy (CE) are recommended for surveillance in Lynch~     syndrome.The investigators will conduct a prospective multicenter randomized non-inferiority~     study. The principal aim is to compare the adenoma detection rate with WLE vs CE. Our~     hypothesis is that HD-white-light endoscopy (WLE) is not inferior to CE. Therefore - under~     expert hands - HD-CE does not add any significant advantage over HD-WLE on adenoma detection~     rate in patients with Lynch syndrome.~   "
47151|NCT02949726|"~     The goal of this study is to find out which immune molecules, cells, and genes are involved~     in the development of lymphedema (LE), so that medicines that target them can be considered~     for treating lymphedema. The hypothesis is that LE is a systemic, autoimmune-like disease~     that is initiated by inflammatory cytokines induced by surgery, radiation, and possibly~     chemotherapy in genetically susceptible patients.~   "
47002|NCT02951663|"~     Purpose: To evaluate adherence, tolerability, and total protein intake in bariatric surgery~     patients provided with ready-to-drink protein supplements, and to evaluate the effects of~     supplementation on body composition, metabolism, and health outcomes.~      Participants: Patients scheduled to under go bariatric surgery aged 18-70 years old.~     Participants will be included if they agree to comply with the study protocol, are free of~     medical conditions that may contraindicate participation, and do not plan to become pregnant~     during the study.~      Procedures (methods): Participants will complete five laboratory visits for the current study~     (pre-screening (visit 1), baseline testing (visit 2), and return visits at 3 weeks (visit 3),~     12 weeks (visit 4), and 24 weeks (visit 5) post-surgery). The treatment group will be given a~     12 week supply of a high protein, low-carbohydrate, low-fat supplement to be taken once daily~     during days 3-7 post-surgery, and twice daily weeks 2-12. The treatment group will follow~     standard of care recommendations put forth by the physician-nutritionist team, but using the~     provided protein supplement to meet recommendations. The control group will be asked to~     follow the standard of care recommendations from the physician-nutritionist team.~      The primary study endpoints will be adherence, tolerability, and total protein intake in~     bariatric surgery patients provided with a 12-week supply of ready-to-drink protein~     supplements. Secondary outcomes will evaluate the effect of a protein supplement on body~     composition (lean mass, fat mass, percent body fat, visceral fat, muscle thickness), resting~     metabolic rate, clinical and endocrine blood values, functional fitness, and responses to~     questionnaires evaluating mood, satiety, functional independence, and health related quality~     of life.~   "
47003|NCT02951650|"~     This will be an open label multicenter study of the safety and efficacy of an active~     implantable VNS device in patients with Crohn's Disease.~   "
47004|NCT02951637|"~     The purpose of this study is to compare chemotherapy and gefitinib in combination with~     gefitinib alone as first-line therapy for adenocarcinoma, in terms of efficacy and safety.~   "
47005|NCT02951624|"~     The primary aim of this study is to investigate the acute effect of the frequency and~     duration of breaks in sitting time on the metabolic risk factor profile.~   "
47006|NCT02951611|"~     60 ASA physical status I or II patients, aged 18-75 years old , scheduled for elective~     video-assisted thoracoscopic lobectomy surgery,will be randomized into 2 groups,with 30~     patients in each group: 1. control group and 2. treatment group. Patients in treatment group~     will receive transcutaneous electrical acupoint stimulation(TEAS) during the surgery and at~     6h and 24h after surgery. Patients in the control group received only TIVA general anesthesia~     and sham electrical stimulation. Serum from patients of both groups will be collected at~     before surgery, 1h and 25h after surgery, respectively. Serum levels of TNF-alpha, IL-1 beta,~     CXCL8, IFN gamma and IL-4 at different time points will be measured and compared between the~     two groups.~   "
47007|NCT02951598|"~     The purpose of this study is to learn about health care use, costs, and clinical outcomes~     over time for amyloid positive participants with early stages of AD in the United States.~     This study is for research purposes only, and is not intended to treat any medical condition.~     No study therapy(ies) for AD will be administered.~   "
47008|NCT02951585|"~     Intra-articular hyaluronic acid injections, also known as viscosupplementation, are a~     treatment option for knee osteoarthritis that serves to restore the decreasing rheological~     properties of synovial fluid. KARTILAGE® CROSS is a visco-elastic gel of highly purified~     reticulated hyaluronic acid. It contains mannitol to provide an anti-oxidative action and to~     avoid hyaluronic acid depolymerization. Reticulation and mannitol increase the residency time~     of the product in the joint cavity then allowing a single injection in painful knee~     osteoarthritis patients.~      The US food and drugs administration (FDA) and European medicine agency (EMA), have recently~     published guidelines recommending a higher level of integration of biomarkers in the~     development and testing of new drugs to advance decision-making on dosing, time and treatment~     effect, trial design, and risk/benefit analysis. Biomarkers can be used not only in the~     process of drug development, but also in the future in assessment of individual patient's~     response to treatment.~      Several soluble biomarkers have been identified as potential candidates to predict or monitor~     the efficacy of intervention. Coll2-1, a degradation product of type II collagen, and~     Coll2-1NO2, a nitrated form of the Coll2-1 peptide have been studied in human osteoarthritis~     and entered the qualification process. Evidences demonstrated them to be pertinent and to be~     foresee as markers used for the diagnosis, the prognosis, the burden of disease and the~     monitoring of a treatment efficacy.~      The aim of this study was to provide with the first kinetic data regarding biomarkers in~     painful knee osteoarthritis patients treated with a new reticulated hyaluronic acid. The~     effects of the treatment were compared to those of saline solution. The primary endpoint was~     a specific osteoarthritis biomarker, Coll2-1. The secondary endpoints were the effects of the~     treatment or placebo on other biomarkers of osteoarthritis, its clinical efficacy and~     tolerance~   "
47009|NCT02951572|"~     As fatigue and daytime sleepiness are typical symptoms of alveolar hypoventilation in~     patients with neuromuscular disorders and thoracic deformations, we hope, by starting~     non-invasive ventilation and improving these symptoms, to increase their physical activity.~   "
47010|NCT02951559|"~     Encephalopathies are a group of central nervous system (CNS) affection with heterogeneous~     etiology. Several causes have been recognized including neurodegenerative, vascular,~     infectious, autoimmune, toxic or allergic affections or secondary to systemic disorders.~     While 30-50% of acute encephalitis remains without etiological definition, definitive~     criteria for neurodegenerative diseases are usually unavailable in vivo and possible or~     probable definitions are used. The Olfactory mucosa (OM) is the part of the nasal mucosa that~     carries the specialized sensory organ for the modality of smell; the olfactory epithelium is~     composed of five principal cell types including olfactory receptor neurons. A sample of OM~     may be collected through a rhinoscopy-guided brushing: it is well-accepted by patients,~     not-contraindicated in patients with raised intracranial pressure and associated with almost~     no side-effects. Nasal brushing has recently been proposed for the in vivo diagnosis of~     Creutzfeldt-Jakob disease (CJD).~      Aims of the project are:~        1. Training of ear throat and nose (ETN), Infectious disease (ID) and neurology (NEU)~          specialists in the technique of nasal brushing;~        2. Conducting a prospective study comparing the use of nasal brushing with gold-standard~          criteria in the diagnosis of Encephalopathies;~        3. Increasing the diagnostic and prognostic power in the diagnosis of encephalopathies.~      A prospective, case control, multicentric study enrolling 400 patients and 100 controls~     (patients with nasal stenosis undergoing rhinoscopy for clinical reasons). Patients will be~     diagnosed and followed according to international guidelines and local clinical practice.~     Cerebrospinal fluid and magnetic resonance imaging will be used, where indicated, for the~     diagnosis according to the clinical or radiological suspect.~   "
47054|NCT02950987|"~     This study is evaluating Whole Body MRI as a possible screening tool to diagnose cancer for~     people with LFS and other inherited cancer predisposition syndromes.~   "
47011|NCT02951546|"~     Nonalcoholic fatty liver disease (NAFLD) is frequently associated with obesity. NAFLD genetic~     susceptibility involves Patatin Like Phospholipase Domain Containing 3 (PNPLA3) rs738409 and~     Transmembrane 6 Superfamily Member 2 (TM6SF2) rs58542926 polymorphisms.~      To date, biochemical mechanisms that affect the metabolic flexibility in obese NAFLD~     subjects, in presence or absence of genetic susceptibility, need to be better clarified.~      Different studies demonstrated that a dietary intervention, accompanied by a physical~     personalized training, significantly reduce either the hepatic fat content either insulin~     resistance in overweight and obese subjects, independently of weight loss.~      On these bases, the aim of the study is to evaluate metabolic flexibility in obese NAFLD~     subjects taking in account their genetics (presence or absence of PNPLA3 and TM6SF2~     polymorphisms) and the histopathological diagnosis of either simple steatosis or nonalcoholic~     steatohepatitis (NASH). In addition, the composition of gut microbiota will be evaluated.~      Finally, in this study, two distinct healthy dietary profiles accompanied by a personalized~     physical training, will be tested in order to comprehend whether and how healthy diets~     could be effective not only in the prevention, but also in the clinical treatment of NAFLD~     and other related conditions.~   "
47012|NCT02951533|"~     The purpose of the study is to compare the efficacy of Guselkumab with commercially available~     active comparator Fumaderm initial/Fumaderm tablets for the treatment of adult participants~     with moderate to severe plaque-type psoriasis who have not yet received any systemic therapy.~   "
47013|NCT02951520|"~     This study aims to describe and to evaluate the effectiveness (success rate) of a supine~     ultrasound (US) guided single-puncture sciatic, obturator and femoral neve block technique~     (SOFT block) in knee surgery.~   "
47014|NCT02951507|"~     Comparison of new design of extra coronal castable precision attachment (OT unilateral~     attachment) and conventional partial denture in patient satisfaction and biting force.~   "
47015|NCT02951494|"~     The AlterG®-anti-gravity treadmill provides lower body weight support which enables~     individuals to exercise without feeling their full body weight. How this body weight support~     influences cardiovascular, respiratory, vascular and metabolic parameters is currently~     unclear. Further, whether body weight support influences the trainability in response to~     moderate continuous exercise is unknown. This investigation has two main goals. First, we~     explore the direct influence of lower body weight support on cardiometabolic parameters~     during maximal exercise testing. Second, we aim to compare changes in cardiorespiratory~     fitness in response to a structured exercise protocol using moderate intensity with and~     without lower body weight support.~   "
47016|NCT02951481|"~     The purpose of this study is to determine whether a bundle of measures specifically designed~     for patients with ICD and applied by and Infectious Diseases expert during a year period~     (2017) will improve the prognosis and reduce the rate of recurrence, compared with the~     baseline phase (2015) in which no intervention was made.~   "
47017|NCT02951468|"~     Background Treatment of clavicular non- and malunion is still challenging. Current surgical~     procedures often result in partially frustrating functional outcome along with high-grade~     subjective impairment and increased rates of revision surgery. However, the combination of~     vital bone graft and a biomechanically sufficient fixation system seems to be a promising~     concept of treatment.~      Methods In this retrospective study, 14 patients with a mean age of 44 years (26-67 years)~     suffering from non-union (n=11) and/or malunion (n=4) of the clavicle were enrolled. All~     patients were surgically treated using an anatomical precontoured locking compression plate~     (LCP) and autologous iliac crest bone graft. Functional outcome was assessed using the age-~     and sex-specific relative Constant Score.~   "
47018|NCT02951455|"~     The current project seeks to implement the Multiphase Optimization Strategy (MOST) and~     Community Based Participatory Research (CBPR) principles to identify the most efficient,~     scalable, and sustainable combination of Community Wise components. Community Wise is a~     manualized multi-level intervention aimed at reducing health inequalities related to alcohol~     and illicit drug use (AIDU).This 2x2x2x2 factorial design will be fully powered to detect~     change in AIDU in a sample of 528 men with substance use disorders and a history of~     incarceration residing in distressed communities with predominantly Black populations.~     Participants will be randomly assigned to one of sixteen experimental conditions.~   "
47019|NCT02951442|"~     The primary objective is to show that the contribution of Klotho by the renal graft is an~     independent determinant of the evolution of the recipient's central arterial stiffness during~     the first year of renal transplant. The contribution of Klotho by the graft will be estimated~     by: its circulating concentrations assay, its urinary excretion assay, and, indirectly, by~     the circulating concentrations of FGF23. The recipient's central arterial stiffness will be~     estimated by the measure of the carotid-femoral pulse wave velocity, noninvasive reference~     method for measuring aortic stiffness in human.~   "
47020|NCT02951429|"~     This Phase IIb, randomized, placebo-controlled, multicenter, international study will~     evaluate the efficacy, safety, and tolerability of sildenafil or placebo added to pirfenidone~     (Esbriet) treatment in participants with advanced IPF and risk of Group 3 pulmonary~     hypertension (PH) who are on a stable dose of pirfenidone with demonstrated tolerability.~     Participants will be randomized to receive 1 year of treatment with either oral sildenafil or~     matching placebo while continuing to take pirfenidone.~   "
47021|NCT02951416|"~     Born out of the European Union 7th Framework Programme funded project European IPF Network~     (eurIPFnet), the European IPF Registry (eurIPFreg) has become Europe's leading database of~     longitudinal data from IPF patients, including control groups of patients with other lung~     diseases. The registry was initiated with the intention of creating a permanent and~     continuously growing record of well defined data on IPF in Europe, in order to increase the~     chances of finding better treatment options for this devastating disease.~      Clinical colleagues who would like to actively participate (both in terms of patient~     recruitment and data analysis) are invited to contact us~     (http://www.pulmonary-fibrosis.net/).~   "
47022|NCT02951403|"~     The study is a prospective case controlled clinical trial. The purpose of the study is to~     investigate the effect of elbow arthroscopy in the treatment for osteoarthritis of the elbow~     when compared to conservative treatment.~   "
47055|NCT02950974|"~     Prospective, crossover, randomized trial to evaluate plasma compositions after loading dose~     of sterofundin solution given to healthy volunteer in the resuscitation manner compared with~     normal saline solution.~   "
47024|NCT02951377|"~     Aim 1: The primary aim of this study is to test the feasibility of Mechanical Diagnosis and~     Treatment (MDT) +/- transforaminal epidural steroid injections (TESI) on pain and disability~     in patients awaiting physiatry consult for lumbar radiculopathy secondary to lumbar disc~     herniation, compared to usual care within the current healthcare system in Calgary, Alberta,~     Canada.~      Hypothesis: the investigators hypothesise that centralisers treated with MDT and~     non-centralisers receiving TESIs + MDT will have demonstrate reductions in self-reported pain~     and disability, compared to usual care controls.~      Aim 2: the investigators will also describe the potential impact on healthcare resources by~     tracking surgical rates and self-reported healthcare utilisation during the study period.~      Hypothesis: based on predicted reductions in pain and disability, the investigators~     hypothesise that there will be a trend toward overall less healthcare utilisation (including~     surgery) in the MDT guided group compared to the surgical wait list group.~   "
47025|NCT02951364|"~     The primary objective of this post-marketing surveillance study is to collect and assess data~     related to the safety and effectiveness of Harvoni® (ledipasvir/sofosbuvir (LDV/SOF))~     treatment regimen, per the approved Korea prescribing information for Harvoni, in routine~     clinical practice in Korea and to report the results to the Ministry of Food and Drug Safety~     (MFDS). Patients will be treated as part of routine practice at Korean healthcare centers by~     accredited physicians.~   "
47026|NCT02951351|"~     The specific aims of this study are to compare patient experience with and without a~     proparacaine drop after povidone iodine. To ensure the extra drop does not interfere with~     antisepsis, conjunctival cultures will be obtained from patients undergoing intravitreal~     injection before and after the application of the extra eye drop. Patients will be randomized~     to undergo additional topical analgesia during intravitreal injection vs. the standard amount~     of topical analgesia. Cultures of the eyelid/conjunctiva will be taken to ensure that the~     additional topical analgesia does not interfere with antisepsis.~   "
47027|NCT02951338|"~     It is important for people with stroke to exercise in order to improve their overall recovery~     and general health. However, these individuals are less physically active than people without~     stroke, and they often do not achieve the recommended frequency, intensity or duration of~     exercise. Low levels of physical activity leads to people with stroke becoming very unfit,~     which can result in functional decline and increased difficulty being active. It is important~     to determine how to encourage people with stroke to be more active in the long-term. The~     transition time between the end of rehabilitation and return to the community might be an~     ideal time to address barriers, and to develop positive habits, knowledge and abilities for~     long-term participation in exercise. We developed the PROPEL program that combines exercise~     with self-management strategies during rehabilitation to promote physical activity after~     rehabilitation. Preliminary pilot findings indicate that people who completed PROPEL were~     more physically active after discharge than those who did not. This study aims to evaluate~     the effect of PROPEL on long-term participation in exercise after discharge from stroke~     rehabilitation. This study will take place at 6 different hospitals. Participants will either~     complete a control intervention (group exercise only) or the PROPEL intervention (group~     exercise plus self-management). Participants' adherence to exercise for 6 months after the~     end of the interventions will be evaluated using activity and heart rate monitors and~     physical activity questionnaires. We expect this study will show that a simple intervention~     delivered during rehabilitation will increase participation in exercise after rehabilitation.~     Increased participation in exercise could then lead to improved stroke recovery and overall~     health, and reduced risk of having another stroke.~   "
47028|NCT02951325|"~     Aim and objectives:~      This trial aims to evaluate the role of adjuvant radiotherapy following chemotherapy in~     patients with high-risk features on histo-pathology after radical surgery for transitional~     cell carcinoma of urinary bladder~   "
47029|NCT02951312|"~     The study assessed the safety and ability of several doses of an orally inhaled medicine [ie,~     Glycopyrrolate Inhalation Solution = GIS] to improve airflow in the lungs when delivered with~     an electronic eFlow nebulizer system in patients with Chronic Obstructive Pulmonary Disease~     (COPD). The study was conducted in 12 patients in 2 parts. Part 1 was designed to find the~     once-a- day GIS dose that produced the highest improvement in lung airflow. Part 2 tested the~     GIS dose with the highest improvement in lung airflow and a placebo (ie, no drug) delivered~     by a general purpose nebulizer. The airflow improvements of the same GIS dose were compared~     between the two nebulizer systems to determine what effect the device had on GIS delivery.~   "
47030|NCT02951299|"~     Acute kidney injury (AKI) has a frequency of 7.0 % in hospital inpatients and is especially~     common in critically ill patients, in whom the prevalence of acute kidney injury is greater~     than 40% at admission to the intensive care unit if sepsis is present. Therefore, alternative~     strategies are required to confer better or more complete renoprotection for those who~     suffered from AKI.~      There had been many studies demonstrated that the phosphodiesterase inhibitor pentoxifylline~     (PTX) is a potent anti-inflammatory, anti-proliferative, and anti-fibrotic agent capable of~     attenuating experimental renal disease such as drugs, ischemic and sepsis induced AKI. We~     thereby design this controlled, non-randomized clinical trial, aiming at investigating the~     potential renoprotective efficacy of PTX, as compared to placebo, in 200 patients with AKI.~   "
47031|NCT02951286|"~     This prospective clinical study will evaluate the effect of high pull headgear for molar~     intrusion, compared with the control group, in adolescent patients with open bite~     malocclusion.~      The study sample will consist of 24 patients with anterior open bite divided equally in two~     groups. The sample will be collected consecutively from patients attending the Orthodontic~     Department at Damascus university.~      A modified version of the OBA (Open Bite Appliance),introduced by Erverdi and Usumez, will be~     applied for all patients. High pull headgears will be used in the first group, while, in the~     second (control) group, Open Bite Appliances will be used only.~      The skeletal and dentoalveolar changes occurring after intrusion of posterior teeth will be~     assessed by using posteroanterior and lateral cephalometric radiographs; pre- and post-~     treatment changes for each group will be evaluated.~   "
47056|NCT02950961|"~     Implementation of Tailored Collaborative Care for Women Veterans (CCWV) is designed to~     enhance primary care-mental health integration for women Veterans, by tailoring services to~     women Veterans' and providers' needs and providing an evidence-based intervention,~     Coordinated Anxiety Learning and Management, to address anxiety and depression in a~     patient-centered approach. CCWV will be implemented in four of the Women's Health~     Practice-Based Research Network sites, with careful attention to local tailoring and~     adaptation to enhance the fit of the care model in varied local contexts.~   "
47057|NCT02950948|"~     The main objective of this study will be to assess the efficacy of natural progesterone at a~     daily dose of 25 mg in restoring a normal luteal phase. The primary end-point will be the~     ongoing pregnancy rate.~      The secondary objectives will be the rate of endometrial biopsy showing an in phase~     endometrium after 3 months of treatment.~      The length of the luteal phase of the menstrual cycle after treatment will also be assessed~     and compared with the initial duration (from LH peak to onset of menstruation).~   "
47032|NCT02951273|"~     General anaesthesia often reduces blood pressure whereby blood flow to the brain and other~     vital organs may become insufficient. Thus, medicine is often administered during anaesthesia~     to maintain blood pressure. However, it is unclear at what level blood pressure should be~     aimed at during anaesthesia.~      Several factors may affect blood flow to the brain during anaesthesia. During surgery on the~     internal organs, a hormone may be released that dilates blood vessels and causes a so-called~     mesenteric traction syndrome characterised by a decrease in blood pressure and flushing. This~     reaction lasts for approximately thirty minutes and is observed in about half of the patients~     who undergo surgery on the stomach and intestines. It is unknown whether a mesenteric~     traction syndrome affects blood flow to the brain. Ventilation is also of importance for~     blood flow to the brain. Thus, blood flow to the brain is reduced by hyperventilation and~     increases if breathing is slower. It is unclear whether the relation between blood flow to~     the brain and ventilation is affected during anaesthesia.~      This study will evaluate how blood flow to the brain is affected by anaesthesia and standard~     treatment of a possible reduction in blood pressure. Further, the study will assess whether~     blood flow to the brain is affected by development of a mesenteric traction syndrome. Lastly,~     the project will evaluate blood flow to the brain during short-term changes in the patient's~     ventilation by adjustments on the ventilator.~      Thirty patients planned for major abdominal surgery will be included in the project. The~     study will take place from the patient's arrival at the operation room and until two hours~     after the start of surgery. Placement of catheters and anaesthesia are according to standard~     care. Blood flow to the brain will be evaluated using ultrasound. Oxygenation of the brain,~     skin and muscle will be evaluated by probes that emit light. Depth of anaesthesia is assessed~     by recording the electrical activity of the brain. Blood pressure is measured by a catheter~     placed in an artery at the wrist and blood samples will be drawn from the catheter.~   "
47033|NCT02951260|"~     The purpose of this study is to evaluate the potential interaction between metformin and~     exercise in order to optimize clinical guidelines for treatment of T2D.~   "
47034|NCT02951247|"~     A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted~     on hard of hearing participants to grant quality control prior to product launch. The aim of~     the investigation series is to ensure zero-defect overall performance of the new hearing~     systems as well as maximum benefit for the participant with the devices in comparison to~     previously outstanding Phonak Hearing Systems.~   "
47035|NCT02951234|"~     Kawasaki disease (KD) is an acute febrile systemic vasculitis most commonly seen in children~     under the age of 5 years old. This trial has been designed as a multi-center, prospective,~     randomized controlled, evaluator-blinded trial with two parallel groups to determine whether~     IVIG alone as the primary therapy in acute-stage KD is as effective as IVIG combined with~     high-dose aspirin therapy. The primary endpoint is defined as CAL formation at 6-8 weeks.~   "
47036|NCT02951221|"~     The primary objectives of the study are to assess the relative bioavailability of the BIIB074~     direct compression formulation (DCF) to the BIIB074 roller compaction formulation (RCF) and~     to determine the effect of a high-fat meal on the pharmacokinetics (PK) of the BIIB074 DCF.~     The secondary objective of the study is to assess the safety and tolerability of BIIB074~     administered as the DCF following single oral dose administration in healthy participants.~   "
47037|NCT02951208|"~     Negative symptoms, which include the loss of motivation, social withdrawal and reduced~     emotional expression are prominent in youth at clinical high risk (CHR) for psychosis. These~     negative symptoms lead to significant functional impairment and enduring disability in these~     youth. At present, there are no established treatments for negative symptoms. Recent evidence~     from independent studies, however, suggests two promising novel treatment approaches for~     negative symptoms, transcranial direct current stimulation (tDCS), and computerized~     remediation strategies. The primary aim of this study is to evaluate if tDCS combined with a~     virtual reality-based computerized remediation (VR) is effective for treating negative~     symptoms in CHR youth, thereby mitigating the enduring functional disability these symptoms~     cause.~   "
47038|NCT02951195|"~     This is a Phase 2, randomized, double blind, placebo and active-controlled, parallel group,~     multicenter study designed to evaluate the safety and tolerability of VX-152 in Triple~     Combination (TC) with tezacaftor (TEZ; VX-661) and ivacaftor (IVA; VX-770) in subjects with~     cystic fibrosis (CF) who are heterozygous for the F508del mutation and a minimal function~     (MF) CFTR mutation not likely to respond to TEZ and/or IVA therapy (F508del/MF), or who are~     homozygous for the F508del mutation of the CF transmembrane conductance regulator (CFTR) gene~     (F508del/F508del).~   "
47039|NCT02951182|"~     This is a Phase 2, randomized, double-blind, placebo- and active-controlled, parallel group,~     multicenter study to evaluate the safety, tolerability, and efficacy of VX-440 in dual and~     triple combination with tezacaftor (TEZ; VX-661) and ivacaftor (IVA; VX-770) in subjects with~     cystic fibrosis (CF) who are homozygous for the F508del mutation of the CF transmembrane~     conductance regulator (CFTR) gene (F508del/F508del), or who are heterozygous for the F508del~     mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ and/or IVA~     therapy (F508del/MF).~   "
47040|NCT02951169|"~     This study evaluates life quality of patients who were diagnosed with gallbladder benign~     disease through Gastrointestinal Quality of Life Index (GIQLI) scale. Researchers will~     establish a database including 20,000 patients. Through observational followup and statistic~     analysis，identifing a model or scale to standardized surgical indication, help surgeons and~     patients determine the best treatment decision.~   "
47041|NCT02951156|"~     Study B9991011 is a multi-center, international, randomized, open label, 2 component (Phase~     1b followed by Phase 3), parallel-arm study of avelumab in combination with various agents~     for the treatment of Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL).~   "
47042|NCT02951143|"~     Tobacco regulatory policies can have unanticipated consequences; therefore, methods that~     would permit prospective estimates of the effects of potential tobacco regulations are~     necessary for the development of tobacco regulatory science. The goal of this project is to~     experimentally assess how smokers purchase and consume reduced-nicotine cigarettes. In~     experiment 1, we will investigate how purchasing/consuming reduced-nicotine cigarettes is~     related to nicotine content and absorption. In experiment 2, we will investigate how~     purchasing/consuming changes when other nicotine products are available in an experimental~     marketplace setting. The proposed projects can directly inform tobacco regulation by~     providing estimates of the real-world effects of novel policies.~   "
47058|NCT02950935|"~     The main objective of this study will be to assess the efficacy of natural progesterone at a~     daily dose of 25 mg/bid in the maintenance of early pregnancy in women with symptoms of~     threatened abortion. The secondary objectives will be the efficacy of progesterone in~     reducing both pain and uterine contractions.~   "
47059|NCT02950922|"~     This is a multi-center, randomized, vehicle-controlled, double-blind Phase 2 study in adults~     and adolescent subjects with mild to moderate atopic dermatitis.~   "
47171|NCT02949466|"~     Using a double-blind, randomized controlled design to investigate the additional therapeutic~     effects of 3 times of combined triamcinolone and hyaluronic acid injections to 3 times of~     hyaluronic acid injections to patients with knee osteoarthritis.~   "
47043|NCT02951130|"~     Infants with congenital diaphragmatic hernia (CDH) usually have pulmonary hypoplasia and~     persistent pulmonary hypertension of the newborn (PPHN) leading to hypoxemic respiratory~     failure (HRF). Pulmonary hypertension associated with CDH is frequently resistant to~     conventional pulmonary vasodilator therapy including inhaled nitric oxide (iNO). Increased~     pulmonary vascular resistance (PVR) can lead to right ventricular overload and dysfunction.~     In patients with CDH, left ventricular dysfunction, either caused by right ventricular~     overload or a relative underdevelopment of the left ventricle, is associated with poor~     prognosis. Milrinone is an intravenous inotrope and lusitrope (enhances cardiac systolic~     contraction and diastolic relaxation respectively) with pulmonary vasodilator properties and~     has been shown anecdotally to improve oxygenation in PPHN. Milrinone is commonly used during~     the management of CDH although no randomized trials have been performed to test its efficacy.~     Thirty percent of infants with CDH in the Children's Hospital Neonatal Database (CHND) and~     22% of late-preterm and term infants with CDH in the Pediatrix database received milrinone.~     In the recently published VICI trial, 84% of patients with CDH received a vasoactive~     medication. In the current pilot trial, neonates with an antenatal or postnatal diagnosis of~     CDH will be randomized to receive milrinone or placebo to establish safety of this medication~     in CDH and test its efficacy in improving oxygenation.~   "
47044|NCT02951117|"~     This is an open-label, multicenter clinical trial designed to evaluate the safety and~     potential efficacy of venetoclax and ABBV-838 combination therapy with dexamethasone in~     participants with relapsed or refractory multiple myeloma (MM) who have received 2 or more~     prior lines of therapy for multiple myeloma (MM). The study will consist of 2 arms: Arm A and~     Arm B (if applicable). Each arm will have a dose escalation and dose expansion portion.~   "
47045|NCT02951104|"~     Comparison of noninvasive cardiac output monitoring device with Fick and thermodilution~     methods during right heart catheterization in patients with pulmonary hypertension.~   "
47046|NCT02951091|"~     In-depth understanding of molecular characteristics of gastric cancer enabled us to realize~     personalized medicine with targeted agents in gastric cancer treatment.The investigators~     initiated open-label, randomized, controlled phase II, multi-arm trial comparing targeted~     therapy based on tumor molecular profiling with standard paclitaxel therapy as second line~     treatment.~   "
47047|NCT02951078|"~     This study is to verify the short-term efficacy and long-term prognosis of thulium laser~     resection compared with conventional transurethral resection of non-muscular invasive bladder~     cancer. Half of participants will receive thulium laser resection of bladder cancer, while~     the other half will receive electrical transurethral resection of bladder cancer.~   "
47048|NCT02951065|"~     This study tests if a bristle-less tooth brush has any measurable effect on gum recession in~     patients who are seen regularly for preventive dental care compared to a regular soft~     tooth-brush.~      Subjects are recruited from patients attending the Western University of Health Sciences~     Dental Center and asked to continue regular preventive dental care while using either the~     test or control brush for a year and using floss and toothpaste supplied by the researchers.~     The exams include measurement of plaque, pockets and gum recession every 3 months, and~     involve photographs and impressions of the teeth and gums to record any changes that occur.~   "
47049|NCT02951052|"~     The Antiretroviral Therapy as Long Acting Suppression (ATLAS) study is being conducted to~     establish if human immunodeficiency virus type-1 (HIV-1) infected adult participants with~     current viral suppression on a regimen with 2 nucleoside reverse transcriptase inhibitors~     (NRTIs) plus a third agent, remain suppressed upon switching to a two-drug intramuscular (IM)~     long-acting (LA) regimen of cabotegravir (CAB) and rilpivirine (RPV). This is a Phase 3,~     multi-phase, randomized, open label, active-controlled, multicenter, parallel-group,~     non-inferiority study in HIV-1, antiretroviral therapy (ART)-adult participants who are~     stably suppressed on a current antiretroviral (ARV) regimen. This study is designed to~     demonstrate the non-inferior antiviral activity of switching to a two drug CAB LA 400 mg +~     RPV LA 600 mg regimen every 4 weeks (Q4W: monthly) compared with maintenance of current ARV~     regimen containing 2 NRTIs plus an INI, NNRTI, or a PI. Eligible participants will be~     randomized (1:1) into the Maintenance Phase at Day 1 to either continue current ART or switch~     to initiate oral therapy with CAB 30 mg + RPV 25 mg once daily for 4 Weeks followed by Q4~     weekly (monthly) CAB LA + RPV LA injections. Following the Maintenance phase at Week 52,~     participants who were randomized to continue their current ART regimen will be given an~     option to switch to CAB LA + RPV LA injections. Those participants would transition to LA~     dosing, beginning with 4 weeks oral CAB + RPV therapy at Week 52, and receive the first IM~     CAB LA + RPV LA injections at Week 56.~   "
47050|NCT02951039|"~     In order to understand the risks and benefits of edoxaban use in a real-world clinical~     setting in the Non valvular Atrial Fibrillation (NVAF) indication, Daiichi-Sankyo proposed~     this non-interventional study to gain insight into the safety (bleeding, liver adverse~     events, all-cause mortality and other drug related adverse events) and efficacy of edoxaban~     use in non-preselected patients with NVAF.~   "
47051|NCT02951026|"~     This long-term extension study is designed to monitor the long-term safety, tolerability, and~     efficacy of treatment of SM04690 or placebo previously injected in the target knee joints of~     subjects with moderately to severely symptomatic osteoarthritis (OA) from a Samumed-sponsored~     SM04690-OA phase 2 or phase 3 study. No additional SM04690 or placebo therapy will be~     administered in this study.~   "
47052|NCT02951013|"~     The hemoglobin concentrations of patients assigned to the restrictive strategy of transfusion~     were maintained in the range of 6.0 to 8.0 g per deciliter, with a transfusion given when the~     hemoglobin concentration fell below 6.0 g per deciliter. Patients assigned to the liberal~     strategy of transfusion, the hemoglobin concentrations were maintained in the range of 8.0 to~     10.0 g per deciliter, with a threshold for transfusion of 8.0 g per deciliter.~      The primary outcome: Death from all causes in the Six months after randomization,~     Perioperative complications: sepsis , Pulmonary complications, Portal vein thrombosis,~     Hepatic artery thrombosis, Adverse event of transfusion.~      Secondary outcomes included: Intraoperative blood transfusion, Postoperative blood~     transfusion, Postoperative inflammatory reaction, Mechanical ventilation time in the~     intensive care unit, Lengths of stay in the intensive care unit and the hospital were also~     recorded.~   "
47053|NCT02951000|"~     Influence of the platysma suture on postoperative pain and wound healing.~   "
47060|NCT02950909|"~     The primary aim of this study therefore is to investigate the effects on pain and disability~     of an emphasized exercise program targeting the deep neck extensor semispinalis cervicis and~     a general exercise program for all neck extensor muscles in patients with chronic neck pain.~     As a secondary aim , the effect of both exercise programs on activation pattern of two neck~     extensor muscles was investigated with electromyography (EMG). The investigators hypothesized~     that both exercise programs would have similar effects on pain alleviation and pain related~     disability, but that the emphasized exercise program for the deep semispinalis cervicis would~     improve its activation more compared to the general exercise program. The results of this~     study will be relevant for designing effective rehabilitation/training programs for patients~     with chronic neck pain.~   "
47061|NCT02950896|"~     Fetal heart rate [FHR] monitoring is used widely to assess the well-being of the baby in the~     delivery period. If it is determined that an urgent cesarean delivery is required because of~     fetal distress, FHR is discontinued once the mother is in the operating room in order to~     allow for surgical site preparation. From this point, there is no real-time monitoring that~     permits assessment of the well-being of the infant. The investigators are evaluating the~     feasibility of intraoperative FHR monitoring using fetal ECG placed on the mother's upper~     abdominal wall and the standard acoustic device routinely used. The investigators will~     compare these to the traditional well-being tests: umbilical arterial blood gas and Apgar~     score.~      The first 15 subjects will be recruited from pregnant women who have scheduled induction of~     labor. The subsequent 40 subjects will be recruited from pregnant women who have scheduled~     cesarean sections.~   "
47062|NCT02950883|"~     The purpose of this study is to assess whether inhalation of 7% hypertonic saline (HS) twice~     daily for 48 weeks reduces structural lung disease as assessed by computed tomography (CT) in~     comparison with inhalation of 0.9% isotonic saline (IS) in preschool children (ages 3 to 6)~     with cystic fibrosis.~   "
47063|NCT02950870|"~     The purpose of this study is to determinate the AMH levels before and after antiviral therapy~     with Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir in comparison with age-matched~     HCV-positive women not undergoing antiviral treatment.~   "
47064|NCT02950857|"~     An open-label study in which 6 patients will receive once-weekly subcutaneous injections of~     EPEG for 4 weeks. Final visit will occur 60 days after study entry~   "
47065|NCT02950844|"~     Atrial fibrillation (AF) is the most common sustained heart rhythm abnormality. Its incidence~     is increasing partly due to the ageing population and it has been referred to as a growing~     epidemic. AF results in irregular contractions of the heart causing unpleasant symptoms of~     palpitations and increasing the risk of stroke, heart failure and death. Percutaneous~     catheter ablation is a safe treatment option in symptomatic patients with AF. The success~     rate of these procedures have improved with time due to our better understanding of AF,~     development of new techniques and technology, and greater physician experience. However, the~     success rate of these procedures still only remains around 70%. This is contributed to our~     limited ability to find the areas that drive the AF.~      STAR mapping is a novel mapping system that has been developed with a view of better~     identifying the sites that drive AF, through taking into account the mechanisms of AF that~     have already been demonstrated. Data from this study will be used to refine the~     identification of drivers in the fibrillation left atrium with enormous potential to simplify~     ablation and improve success rates and thereby reducing the need for further procedures.~      To better validate this mapping system the investigators also aim to use it in participants~     with atrial tachycardia (AT), which is a heart rhythm abnormality of which the mechanism can~     be readily identified with the existing mapping systems used in clinical practice. The~     investigators will demonstrate that the STAR mapping algorithm can effectively map AT.~      To gain further understanding of the changes that occur in the left upper chamber of the~     heart in the context of AF half of the participants with AF will undergo cardiac magnetic~     resonance imaging to assess for the presence of scar. This will enhance our understanding of~     how atrial remodelling promotes AF, which may point to ways of modifying this process and~     preventing AF.~   "
47066|NCT02950831|"~     The purpose of this study is to assess feasibility of using wearable sensors to capture~     objective assessments of patient's activity and sleep quality during the spinal cord~     stimulation (SCS) treatment continuum.~   "
47067|NCT02950818|"~     To evaluate the effectiveness of Take Heart, a behavioral/educational program for adults age~     50+ with heart disease, or with at least two risk factors for heart disease, that helps them~     to better manage their health condition(s). Take Heart is a new version of an evidence-based~     program that has recently been adapted to be suitable for the needs of adults residing in~     Detroit.~   "
47068|NCT02950805|"~     This study will assess the effect of inhaled AZD5634 on Mucociliary clearance (MCC) in~     patients with Cystic fibrosis (CF) after single-dose administration.~   "
47069|NCT02950792|"~     Current dose escalation regimens with and without chemotherapy have failed to achieve~     improved local control and overall survival over standard of care therapy to date.~     Difficulties with dose escalation have been largely due to dose limiting toxicities of~     surrounding normal organs, in particular to the normal lung parenchyma, and esophagus. Real~     time, online adaptive planning using magnetic resonance imaging (MRI) could achieve~     significant volume reduction of primary lung disease over the course of therapy, thereby~     reducing dose to normal structures, and providing a mechanism in which to dose escalate~     safely, and more effectively with accurate target delineation.~      The investigators hypothesize that MRI based adaptive planning will provide a novel method to~     dose escalate safely with acceptable organ at risk doses. In addition, further improvements~     in radiotherapy targeting accuracy, normal tissue avoidance, and conformality of~     target-tissue coverage will be achieved through the use of 4D real-time tracking which is~     derived by deformably registering daily MR and planning MR (MRsim) and Computed Tomography~     Simulator (CTsim) with advanced non-rigid image-registration tools.~   "
47080|NCT02950649|"~     This project is designed to assess the impact of pre-operative use of non-invasive~     hemodynamic monitoring technologies on improving peri-operative and post-operative care of~     moderate to high-risk surgical patients with poor functional status by improving the~     detection of reduced cardiovascular function.~   "
47081|NCT02950636|"~     The purpose of this study is to learn if a structured yoga program can reduce anxiety,~     improve depression, and improve quality of life in patients with medication resistant~     epilepsy (MRE).~   "
47082|NCT02950623|"~     Cross over design the investigator divide participants to two groups group (A) will receive~     rapid heat cured denture base material and group (b) will receive the acrylic denture~     modified by titanium dioxide nanoparticles and after washout period alternatively group (a)~     will receive the acrylic denture modified by titanium dioxide nanoparticles AND group (b)~     will receive rapid heat cured denture base material the investigator will take swaps from~     dentures to count the anaerobic bacteria.~   "
47070|NCT02950779|"~     Inflammatory bowel disease (IBD) is a chronic disease, which causes inflammation of the gut.~     People with this disease are often poorly nourished. Problems caused by poor nutrition such~     as poor wound healing can be reduced if it is recognised and treated early.~      When people with IBD attend outpatients clinic with their IBD specialist they are weighed and~     their BMI calculated to indicate if they are poorly nourished. Weight and BMI may not always~     provide a good assessment of how well nourished a person is because it does not describe the~     amount of muscle in the body in proportion to fat. A person with a low or decreasing amount~     of muscle but a normal or high BMI is at risk of nutritional problems. Measuring the amount~     of muscle someone with IBD has in routine practice poses a challenge to clinicians due to~     time constraints. One-way of measuring the amount of muscle a person has is to measure their~     muscle strength. This can be measured by recording the strength of a person's handgrip.~     Handgrip strength can be measured using a hand-held device called a dynamometer.~      This study aims to test whether it is possible to measure the handgrip strength of people~     with IBD attending outpatient's clinic. It also aims to test how the measure obtained~     compares with other methods of assessing whether someone is malnourished and their health.~     People with a diagnosis of IBD who are aged 18 or older and who are scheduled to attend IBD~     outpatients clinic in one hospital will be asked to take part in the study. Their handgrip~     strength will be measured each time they attend clinic over a nine-month period in addition~     to other information about their health and nutritional state. This study forms part of a~     Masters in Research being undertaken with The University of Southampton.~   "
47071|NCT02950766|"~     This research study is evaluating a new type of Kidney Cancer vaccine called Personalized~     NeoAntigen Cancer Vaccineas a possible treatment for Kidney Cancer.~      The following intervention will be involved in this study:~        -  Personalized Neoantigen Vaccine~        -  Poly-ICLC (Hiltonol)~        -  Ipilimumab~   "
47072|NCT02950753|"~     Lactated Ringer's (LR) solution bolus is commonly administered in the emergency department~     setting to seriously ill patients. It is also common to obtain blood samples to determine~     serum lactate levels to aid in the assessment of the patient's degree of illness. This study~     endeavors to determine if serum lactate levels are affected by LR fluid administration in~     healthy adult individuals as compared to those who receive Normal Saline (NS). Healthy adult~     volunteers will be used as subjects so that the illness of hospital patients does not~     confound the results.~   "
47073|NCT02950740|"~     Food intake pattern and lifestyle are associated with the nutritional status and intestinal~     microbiota composition, and such factors are important for the proper growth and development~     during early childhood, as well as for the health throughout life. This cross-sectional and~     multicenter study will include a total of 200 children aged between 1-3 years, enrolled in~     early childhood public schools from different regions of Brazil (Santo André, Uberaba, Porto~     Alegre and Natal). Data on birth and gestational history will be collected in a form.~     Nutritional status will be assessed by determining the weight and height, with subsequent~     calculations and classification of nutritional indices. A single blood sample will be~     collected to investigate the blood levels of vitamins A and D, iron, calcium, alkaline~     phosphatase and zinc, and feces will be collected for intestinal microbiota analysis. Food~     intake will be assessed by direct weighing of food in 2 non-consecutive days. Considering the~     importance of a well-balanced diet and its effects on the child's growth, development and~     intestinal colonization, this study purpose is to investigate potential associations among~     food intake, nutritional status and intestinal microbiota of early childhood infants from~     four regions of Brazil.~   "
47074|NCT02950727|"~     In this current study a comparison between 3 positional screws versus the adjustable plating~     system in conjunction with 2 positional screws. The patients will be selected to have~     retrognathic mandible requiring advancement. Hypothetically the advantage of the adjustable~     plating system will be compared with the three positional screws. In theory, the~     investigators will be using the inherent advantage of the intraoperative flexibility of the~     adjustable plating system in verifying the position of the proximal segment (condylar~     segment), hence eliminating the immediate postoperative relapse that is reported with using~     three positional screws. This will be evaluated both clinically and cephalometrically.~   "
47075|NCT02950714|"~     This study asks whether persons with lupus will use and uptake the information and services~     of the web-based lupus interactive navigator (LIN) on a regular basis and whether this uptake~     will be associated with better self-management, improved coping, higher sense of control over~     their life, and overall improved health.~      Systemic lupus erythematosus is an incurable chronic multi-organ inflammatory disease that~     affects preferentially young women. Unmet needs include a 15% excess in mortality, high~     morbidity and poor work outcomes. Despite prevalence of 1:2000, lupus is mostly unknown from~     the public and access to specialized care remains limited. Therefore, persons with lupus and~     their caregivers have difficulty finding high quality information relevant to their lupus~     journey.~      The LIN research team consists of a lupus clinical expert and researcher, a clinical~     psychologist and behavioral researcher, and a health information specialist. This team,~     funded by the Canadian Institutes of Health Research (CIHR), was responsible for the~     development of the LIN, a web-based navigator designed to promote self-care. The LIN is~     completed and the team will work with several stakeholders for dissemination: Lupus Canada,~     the Canadian Network for Improved Outcomes in Systemic Lupus Erythematosus (CaNIOS), the~     Arthritis Alliance of Canada, and lupus patient advisers. CaNIOS centres will be to~     randomized to immediate access to the LIN (LIN_NOW group) or usual care with crossover at 3~     months (LIN_WAIT group). At baseline, all patients meeting entry criteria will be contacted,~     and asked to complete online questionnaires. At three months, a second online assessment will~     be performed before crossing over those from the centres randomized to usual care in order to~     now provide them with an access to the LIN. A final assessment will be performed at six~     months. Comparisons of baseline versus LIN exposure over three months will be performed in~     all patients at the end of the study; comparison of LIN use versus usual care will be done at~     three months; and retention of use at six months after LIN exposure will be documented in the~     first group randomized to LIN. The main outcome will be the Patient Activation Measure, a~     valid tool that measures the level of patient engagement. Secondary outcomes will include~     variables describing access and use of the LIN captured by the LIN server, coping,~     self-efficacy, and global health status.~   "
47076|NCT02950701|"~     The purpose of this study is to collect non-invasive opportunity sample data in suspected or~     known cases of carbon monoxide poisoning.~   "
47077|NCT02950688|"~     The purpose of this study is to evaluate the immune response produced by a seasonal live~     attenuated influenza vaccine (LAIV) when compared to placebo. The initial vaccination will be~     followed 2 months later by an inpatient trial evaluating safety, infectivity, clinical~     response, and viral shedding after exposure to the wild-type A/California/2009-like influenza~     challenge virus.~   "
47078|NCT02950675|"~     The relationship of body function, participation and quality of life in patients with burn: A~     longitudinal study~   "
47079|NCT02950662|"~     The aim of this study is to compare the clinical effect of PEEK housing vs. metal housing in~     terms of retention and patient satisfaction~   "
47084|NCT02950597|"~     Study Details What is the study design? (eg, randomized, double-blind) Observational~     Prospective Study What are the overall objectives of the study? This project is designed to~     assess the feasibility of using a non-invasive hemodynamic monitoring device in heart failure~     outpatient clinics. There will be no alteration to patient management for this study. Rather~     this study seeks to assess the utility of the device in this patient care setting by~     surveying the clinicians involved.~      What is the primary endpoint? For this phase I study, the primary endpoint will be the heart~     clinician's survey results.~      What is/are the secondary endpoint(s)? Secondary markers will include: patient survey~     results, heart failure classification, renal function, blood pressure, cardiac function~     tests, and pulmonary function tests.~      How your research will contribute to the advancement of scientific knowledge? ☒This study~     will confirm/strengthen existing knowledge.~        -  This study will test a completely novel hypothesis.~        -  This study will explore novel endpoints. ☐Other [please describe]:~   "
47085|NCT02950584|"~     Measurement of surface roughness of tow different material of denture base to find out which~     material is more hygienic by decreasing the amount of bacterial accumulation.~   "
47086|NCT02950571|"~     This study will be a randomized controlled trial that investigates the effectiveness of~     digital picture frames (DPF) installed in inpatient rooms on long stay inpatient wards~     servicing schizophrenia clients at CAMH. The effects on client experience will consider the~     domains of self-concept, interactions with healthcare staff, perception of space, and~     implications for the recovery process. The comparison of inpatient client experience with~     DPFs versus a control group (Treatment as Usual - TAU), offers the opportunity to examine the~     effectiveness of this type of environmental adaptation. This trial builds upon earlier work~     that demonstrated the feasibility of DPFs in this context.~   "
47087|NCT02950558|"~     This pilot study will test the hypothesis that prolonged regional peripheral nerve block will~     reduce development of chronic pain in patients undergoing surgery for ankle fracture compared~     to standard of care. Subjects will be followed for one year.~   "
47088|NCT02950545|"~     It is a common clinical practice to leave small amounts of astigmatism uncorrected in contact~     lens wearers. Therefore, some drivers who have astigmatism and wear contact lenses may~     experience blur while driving. The purpose of this study is to determine if correcting small~     amounts of astigmatism with contact lenses will improve driving safety.~   "
47089|NCT02950532|"~     The objective of this investigation is to confirm the results obtained in a pilot study~     showing that certain radiological parameters based on computed tomography (CT) scans seem to~     reliably detect posterior ligament complex (PLC) injury without the need for Magnetic~     Resonance Imaging (MRI)~   "
47090|NCT02950519|"~     There is no accepted standard for the frequency of monitoring endotracheal tube cuff~     pressures (ETCP). Investigators plan on comparing two strategies for monitoring ETCP in~     mechanically ventilated patients. The two strategies will be the currently employed practice~     at Barnes-Jewish Hospital (BJH) which requires ETCP to be assessed immediately after the~     endotracheal tube is placed and after any manipulation of the endotracheal tube to include~     repositioning, manipulation of the cuff volume, or presence of an audible leak. Investigator~     will compare this current practice to a more intensive monitoring of ETCP which is employed~     at some hospitals and includes the same elements as noted in the current practice plus~     monitoring ETCP every work shift (every 8 hours or three times per day).~   "
47091|NCT02950506|"~     The purpose of this study is to investigate whether tDCS enhances the effect of cognitive~     remediation therapy on cognition and functional outcome in patients with epilepsy. There has~     been evidence that working memory performance is enhanced in healthy subjects. Acute tDCS~     studies have found improvements in working memory performance in subjects with other~     neurological diseases. To date, there have been no published studies examining whether can~     enhance learning during multi-session cognitive remediation over 2 weeks in subjects with~     epilepsy. This study could have potential application as a non-invasive clinical intervention~     for interictal dysfunction in epilepsy.~   "
47092|NCT02950493|"~     Use of Reactivated DEFINITY® in Patients Undergoing Stress Echo Purpose of the study: Each~     patient undergoing a stress echocardiogram uses a full vial of DEFINITY® contrast agent.~     During infusion, this often condenses back to its liquid phase due to manual pressure applied~     in the syringe. At this point, it is not optimal to be used at current ultrasound settings~     for stress echocardiography. This research project will test whether this condensed DEFINITY®~     can be reactivated by ultrasound using the same transducer used to image the patient.~      Eligibility: Same criteria as required for stress echo procedure. Interventions and~     Evaluations: Inject condensed DEFINITY® at end of stress test Follow Up: The patient would be~     observed by echo lab staff for half an hour following completion of the stress test. There~     would be no longitudinal follow up.~   "
47093|NCT02950480|"~     A 2 arm, 90 patient (45 per cohort) trial in patients with breast cancer who will be~     undergoing mastectomy with immediate tissue-expander reconstruction to determine whether~     treatment with zafirlukast (20mg PO BID) can reduce or prevent the development of capsular~     contracture.~   "
47094|NCT02950467|"~     The purpose of this study is to determine whether psilocybin-assisted group psychotherapy is~     a safe and feasible treatment for demoralization in long-term AIDS survivors (LTAS).~   "
47095|NCT02950454|"~     This is a pilot trial to explore the cardiovascular of eight weeks of twice weekly high~     intensity interval training in people with progressive multiple sclerosis. A control group of~     people with progressive multiple sclerosis will undergo continuous moderate intensity~     exercise, twice weekly for 8 weeks.~   "
47096|NCT02950441|"~     This study is designed to assess the physiological consequences of elevating Nicotinamide~     Adenine Dinucleotide (NAD+) availability using Nicotinamide Riboside (NR) supplementation in~     skeletal muscle tissue, and examine its effect upon muscle metabolic phenotype.~   "
47097|NCT02950428|"~     The purpose of this investigation is to collect data pertaining to the safety and performance~     of the ACURATE neo (TM) Aortic Bioprosthesis as implanted with the ACURATE neo (TM) TA~     Transapical Delivery System. This device is intended for treatment of subjects with severe~     aortic stenosis (AS) who have high risk for conventional aortic valve replacement (AVR)~     surgery. The ACURATE neo (TM) Aortic Bioprosthesis is intended for use via minimally-invasive~     transapical implantation in a well-defined population.~   "
47098|NCT02950415|"~     Children undergoing anesthesia are often very frightened by the experience. This can lead to~     bed wetting, nightmares and stranger anxiety that can last for weeks. Moreover, this can~     influence their future experiences with anesthesia and surgery. The investigators believe the~     presence of a parent via video might work better as parental fear is not transferred to the~     child. The investigators also believe that parents who are coached on how to assist their~     child during anesthesia will have a better impact. As such the investigators are carrying out~     this study to assess whether parents who are coached and are present in either video or~     physical form will be more effective in reducing anxiety at induction of anesthesia.~   "
47099|NCT02950402|"~     This study evaluates whether the consumption of California dried plums can be beneficial to~     your health. Previous studies using dried plums have shown beneficial effects on bone and~     cardiovascular health. In addition the investigators hope to learn how dried plums might~     change your bowel habits, and if the carbohydrates in the plums are fermented in your~     digestive tract.~   "
47100|NCT02950389|"~     Immunoglobulin light chains are classified as middle molecule uremic toxins able to interact~     with B lymphocyte membranes leading to the activation of transmembrane signaling. The ensuing~     impairment of neutrophil function can contribute to the chronic inflammation state of uremic~     patients, and the increased risk of bacterial infections or vascular calcifications. The aim~     of this crossover observational study was to assess the difference in free light chain~     removal by three different hemodialysis filters in patients not affected by multiple myeloma.~      Free light chain removal was compared in the polymethylmethacrylate (PMMA) membrane Filtryzer~     BK-F, the polyphenylene HFR17 filter and the conventional polysulfone filter F7 High~     Performance dialysers (HPS). Twenty chronic hemodialysis patients were enrolled. The patients~     were randomized into two groups of treatment lasting six weeks each. The dialysis sessions~     checked were the midweek sessions and the blood was drawn at times 0, 120' and 240'. Kappa~     (k) and lambda (l) light chain levels, beta2microglobulin (β2M), C reactive protein (CRP) and~     albumin were checked.~   "
47101|NCT02950376|"~     The purpose of this research is to develop an objective assessment based on the virtual~     reality techniques which is used for evaluate addiction severity.~   "
47102|NCT02950363|"~     The purpose of this study is to determine whether use of a suite of smart phone enabled~     mobile health devices can reduce burnout in medical trainees. Such applications can then be~     used in more general populations with the same goal in mind.~   "
47103|NCT02950350|"~     Cervical cancer is the most common reproductive malignancy in developing country. Due to~     local invasion, radical hysterectomy cannot be performed in advanced cervical cancer (FIGO~     IIB - IVA) , so that radiation combined with chemoradiation (RCTX) is a traditional treatment~     nowadays. Lack of precise treatment strategies, recurrent ratesand metastasisis high ,and the~     5-year survival rate is less than 50%. Therefore, it needs to explore a new strategy for~     improving the prognosis of advanced cervical cancer.~      The prognosis of cervical cancer is closely related to its stages ,while the current FIGO~     clinical stage is too subjective , for example different gynecologic oncologists may give~     different diagnosis to the same patient. MRI, CT, PET/CT imaging examinations are commonly~     used as a referrence for clinical staging, but the sensitivity and specificity are not~     satisfied. In addition, lymph node metastasis significantly impacts the prognosis of cervical~     cancer . However, the lymph node invasion is not in current staging criteria.~      Precision treatment after surgical staging is recommended by NCCN recently .Surgical staging~     in patients with advancedcervical cancer is safe and does not delay primary RCTX in few~     randomized study.Whether overall survival benefit the long-term clinical follow-up surgical~     staging is unknown.Blocking bilateral uterine artery can effectively reduce the tumor size~     and increase the operability , which has been conformed in locally advanced cervical cancer.~     Furthermore, ovarian dysfunction caused by RCTX could be avoided by ovarian transposition via~     surgical staging .~      Based on this, we suggesta new surgical stagingfor patients with advanced cervical cancer ,~     which includinglaparoscopic pelvic and para-aortic lymphadenectomy , uterine blood vessel~     blocking and ovarian transportation, in order to perform individualized postoperative RCTX,~     reduce tumor load , preserve ovarian function and improve life quality.~   "
47104|NCT02950337|"~     Lung cancer is the leading cause of cancer death in both men and women in the United States.~     In 2014, an estimated 224,210 men and women were diagnosed with carcinoma of the lung and~     bronchus, resulting in 159,260 deaths. Per the current National Comprehensive Cancer Network~     (NCCN) guidelines, the standard of care for early-stage non-small cell lung cancer (NSCLC) is~     lobectomy with lymph node dissection. Historically, medically inoperable early-stage NSCLC~     patients have been offered definitive external beam radiotherapy (EBRT) as primary management~     but, overall, studies have consistently shown poor patient outcomes. Stereotactic body~     radiation therapy (SBRT) is a technique which delivers very high doses of radiation per~     fraction over one to five fractions to precisely defined volumes with steep dose gradients.~     SBRT is commonly utilized for the treatment of biopsy-proven early stage NSCLC in the~     medically inoperable patient.~   "
47105|NCT02950324|"~     The purpose of this study is to evaluate the effect of a multimodal pre-operative~     prehabilitation programme during neo-adjuvant therapy on cardiopulmonary exercise performance~     and insulin resistance prior to resection for oesophago-gastric cancer.~   "
47106|NCT02950311|"~     This is a randomized, double-blind, placebo-controlled study of children, age 6 months to 3~     years, with a diagnosis of Otis media with effusion (OME) based on examination by a provider~     at a Duke- affiliated otolaryngology clinic.~   "
47107|NCT02950298|"~     The primary purpose of this study is to:~        -  Document the developmental outcomes of individuals with Pompe disease treated with~          long-term enzyme-replacement therapy (ERT) through school-age (ages 6-18) using measures~          of cognitive functioning, academic skills, and speech and language abilities.~        -  Investigate possible cognitive processing speed weaknesses using BrainBaseline~          neurocognitive assessment software.~        -  Investigate the relationship between behavior and other developmental factors including~          speech and language ability and cognitive ability.~        -  Explore if the use of selected iPad applications may help strengthen cognitive~          processing speed in children with Pompe disease~   "
47108|NCT02950285|"~     The overall goal is to improve outcomes among patients with atrial fibrillation (AF) by~     preventing stroke. The investigators propose to implement an automated algorithm using~     electronic medical record (EMR) data to alert physicians in a large primary care practice~     network at the Massachusetts General Hospital (MGH) of their patients with AF and elevated~     stroke risk that are not taking an anticoagulant for stroke prevention. The investigators~     hypothesize that interventions to notify physicians of such individuals may prompt~     reassessment for the need for anticoagulation, and thereby increase guideline-indicated~     anticoagulation rates. Additionally, in a survey component, physicians will characterize~     reasons for not pursuing anticoagulation in AF patients at elevated risk for stroke.~   "
47111|NCT02950246|"~     Implementation of perineural catheters may lead to infection by catheter colonization.~     Catheters may be colonized by the bacteria present on the skin. This is most often commensal~     organisms as Staphylococcus or gram negative bacilli. In a large study of 1416 peripheral~     nerve catheters, 28.7% of catheters were cultured positive. This colonization is most often~     silent because in the same study only 3% of patients had signs of local inflammation and one~     psoas abscess was observed (0.07%). The germs are most often coagulase negative staphylococci~     (61%) and gram negative bacillus (21.6%).~   "
47112|NCT02950233|"~     The objective of the PAIN-STOP trial is to assess the feasibility of a larger randomized~     controlled trial (RCT) evaluating NMDA antagonists and IV steroids, as compared to placebo,~     in decreasing the chances of clinically significant persistent post-surgical pain (PPSP)~     after video assisted thoracoscopic surgeries (VATS). This is a multi-centre randomized,~     controlled clinical trial with a 2 x 2 factorial design. The pilot phase of the trial will~     recruit 48 patients and follow them for 3 months. Patients will be randomized to one of four~     groups: 1) NMDA active + Steroid placebo; 2) Steroid active + NMDA placebo; 3) NMDA active +~     Steroid active; 4) NMDA placebo + Steroid placebo.~   "
47113|NCT02950220|"~     This phase I/Ib trial studies the side effects and best dose of ibrutinib when given together~     with pembrolizumab and to see how well they work in treating patients with non-Hodgkin~     lymphoma that has come back or does not respond to treatment. Monoclonal antibodies, such as~     pembrolizumab, may interfere with the ability of cancer cells to grow and spread. Ibrutinib~     may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~     Given pembrolizumab and ibrutinib may work better in treating patients with non-Hodgkin~     lymphoma.~   "
47114|NCT02950207|"~     Mono-centric, observational, prospective study, designed for pts with diagnosis of~     hormone-positive breast cancer to evaluate the correlation between the response to hormonal~     treatment indicated by the reduction of the level of Ki67 and miRNA100 in two groups of~     patients~   "
47115|NCT02950194|"~     The aim of this study is to evaluate this multidisciplinary surgical approach of PPAWI~     (one-step procedure a panniculectomy by a plastic surgeon was performed together with a mesh~     augmentation of the abdominal wall by a general surgeon) at least 1 year post-operatively.~     Evaluation of the PPAWI approach by clinical examination with Quality of Life questionnaire~     and by ultrasound examination.~   "
47116|NCT02950181|"~     This study involves looking at Cerebral oximetry measurements in pediatric and neonatal~     patients who are experiencing a critical illness. Such as Altered mental status, seizures,~     trauma, sepsis, etc.~   "
47117|NCT02950168|"~     Patients receiving Novel Oral Anticoagulation (NOACs) undergo diagnostic and therapeutic~     procedures at a rate of 10% per year. Short half-lives and rapid onset of action allow for~     short periods of NOAC interruption without heparin bridging. There is only minimal~     information on the peri-procedural usage pattern of edoxaban and the related outcome data~     currently available. Therefore, further real-world clinical data on the peri-procedural usage~     pattern of edoxaban within any diagnostic or interventional procedure in patients with~     non-valvular atrial fibrillation (NVAF) or venous thromboembolism (VTE) will be collected in~     this registry.~   "
47118|NCT02950155|"~     A randomized, double-blind, placebo-controlled multicenter study evaluating the safety and~     efficacy of Rituximab (Mabthera®) in patients with new onset generalized myasthenia gravis~     (MG).~   "
47119|NCT02950142|"~     Cluster randomised controlled trial to evaluate what the effect is of evidence-based order~     sets aimed at five indications on the appropriateness of laboratory test ordering in primary~     care.~   "
47120|NCT02950129|"~     The subjects will undergo a specific physical exam of tests reported to be diagnostic of~     sacroiliac joint (SIJ) pain prior to receiving the routine injection in the SIJ that which is~     being performed as part of their normal medical care. Routine care involves use of any number~     of these tests, but doesn't routinely include assessment of all 6 tests in all patient's~     treatment. The subject will fill out a Visual Analog Scale for pain and a pain drawing prior~     to and after the injection.~      The tests will be repeated after the injection.~      The investigators propose to investigate a cluster of tests proposed by Laslett as well as~     compare the results of the ASLR and the Gillet Test both before and after SIJ injection to~     determine the validity of these tests in a low back patients presenting for injections~     thought to be from the sacroiliac joint. The secondary purpose would be the development of a~     clinical predictor rule to determine examination characteristics of patients who may benefit~     from intraarticular injections of the SIJ.~   "
47121|NCT02950116|"~     Chronic respiratory diseases (CRDs) affect the airways and other structures of the lungs and~     thereby lead to ventilation inhomogeneity. The most common CRDs in children are asthma,~     bronchiectasis and cystic fibrosis (CF). All three are obstructive diseases. However, while~     asthma is mostly characterized by obstruction due to bronchoconstriction of the airways,~     obstruction in bronchiectasis and CF originates primarily from mucus retention due to~     abnormal airway clearance mechanisms.~      The Nitrogen Multiple Breath Washout test (N2-MBW-test) is a robust and sensitive detector of~     early pulmonary changes and ventilation inhomogeneity. The minimal cooperation which is~     required for this test makes it very convenient for use in any age category.~      Research on LCI described it as a reliable indicator of obstructive lung disease in pediatric~     CF patients as from 6 years of age. Whether LCI is a reliable parameter for early lung~     disease in asthma children is less clearly demonstrated. No data were found on LCI calculated~     from the N2-MBW-test in children with bronchiectasis.~   "
47122|NCT02950103|"~     Synthetic phosphoethanolamine is a primary amine which has a critical role in the~     biosynthesis of cell membranes. Pre-clinical models have shown potential anticancer activity.~   "
47134|NCT02949947|"~     The goal of this clinical research study is to compare Injectafer® (ferric carboxymaltose)~     with an iron supplement to learn which may be more effective in improving red blood cell~     counts in patients who have iron-deficiency anemia (a low red blood cell count) because of a~     gastrointestinal stromal tumor (GIST) and/or systemic therapy.~      The safety of ferric carboxymaltose will also be studied.~      This is an investigational study. Ferric carboxymaltose is FDA approved and commercially~     available to treat iron deficiency anemia; however, it is considered investigational to use~     in patients who have cancer-related or systemic therapy-related anemia.~      Up to 50 participants will take part in this study. All will be enrolled at MD Anderson.~   "
47123|NCT02950090|"~     MobilWise, a worksite physical activity intervention for employees at high risk for knee~     osteoarthritis (OA), is being tested in a developmental randomized controlled trial at a~     collaborating worksite to determine if remotely- coached physical activity counseling can~     increase and sustain physical activity in this population. Knee osteoarthritis is a major~     public health problem and a leading cause of disability and work absenteeism/presenteeism in~     the US workforce. The overarching goal of this program is to develop and disseminate an~     affordable, efficient, efficacious physical activity intervention to large groups of~     employees at risk for knee OA. The Mobil Wise intervention is administered by health~     professionals, who will use data transmitted from an affordable accelerometer-based personal~     monitor (Fitbit Flex) via customized remote coach interface to 1) allow the remote coach to~     view and collect physical activity data generated by the personal monitor, and 2) use that~     data to formulate and provide tailored behavioral support, using motivational interviewing.~     This project has the potential to have a tremendous impact on improving symptoms and quality~     of life of persons with chronic knee pain and decreasing the functional limitation, work~     absenteeism/presenteeism, and soaring healthcare utilization associated with knee OA.~   "
47124|NCT02950077|"~     The study is a 'pilot study' to assess the effect of a mindfulness-based stress reduction~     (MBSR) intervention on patients with autoimmune liver disease specifically autoimmune~     hepatitis type I. MBSR is a standardized intervention that has shown benefit in addiction~     disorders and other psychiatric disorders. There has been no study evaluating or showing the~     benefit of the use of MBSR in autoimmune liver disease. With published data showing the~     evidence of an association of stress and relapse in autoimmune hepatitis, it is hypothesized~     that such an intervention such as MBSR may have therapeutic effect in patients with~     autoimmune liver disease.~   "
47125|NCT02950064|"~     This is a phase 1, Open-label, multicenter Dose Escalation study of BTP-114, a novel platinum~     product, in patients with advanced solid tumors and BRCA or other DNA repair mutation. This~     clinical study is comprised of 2 sequential parts: Part 1 (Dose Escalation) and Part 2~     (Expansion). The purpose of this study is to evaluate the safety, pharmacokinetics and the~     anti-cancer activity of BTP-114.~   "
47126|NCT02950051|"~     The aim of this study is to evaluate if standard chemoimmunotherapy (FCR, BR) in frontline~     treatment of physically fit CLL patients without del17p or TP 53 mutation can be replaced by~     combinations of targeted drugs (Venetoclax, Ibrutinib) with anti-CD20-antibodies (Rituximab,~     Obinutuzumab), which may induce extremely long lasting remissions.~   "
47127|NCT02950038|"~     The goal of this clinical research study is to learn if Imbruvica (ibrutinib) alone and then~     in combination with Opdivo (nivolumab) can control NSCLC in patients who have received~     previous chemotherapy treatment.~   "
47128|NCT02950025|"~     In light of this new technology and preliminary findings of low toxicity of online, adaptive,~     magnetic resonance (M)-guided stereotactic radiation on a single arm prospective study, the~     investigators propose to compare this technique to online MR-guided stereotactic body~     radiation therapy (SBRT) without adaptation. Online plan adaptation increases treatment times~     for patients and comprises an increased burden on technical and clinical staff. Although~     preliminary trial results are encouraging, it remains unclear if the dosimetric benefits of~     online-adaptive planning studies will translate to measurable improvements in clinical~     outcomes that merit its routine use. In our preliminary study, plan adaptation was most often~     required when tumors were adjacent to the gastrointestinal tract (the esophagus to the~     sigmoid colon), as those structures were most commonly the dose-limiting structures and were~     noted to change in location on a day-to-day basis. For these reasons, abdominal disease sites~     have historically highlighted the limitations of SBRT. Specifically, the investigators will~     enroll patients with oligometastatic or unresectable primary disease of the non-liver abdomen~     to a randomized, prospective trial.~      Patients will be randomized to one of two treatment arms, in which they will receive either~     online-adaptive, MRI-guided SBRT or non-adaptive MRI-guided SBRT. Both patient groups will~     undergo MRI simulation and MRI treatment localization with online MR monitoring and/or~     gating. All patients will be treated in five fractions over one to two weeks. By adhering to~     strict normal tissue constraints, the investigators expect toxicity to be within the current~     standard of care for the non-adaptive arm, with reduction in toxicity in the arm of patients~     who undergo adaptation based on daily anatomic changes.~   "
47129|NCT02950012|"~     The purpose of this study is to investigate the effects of OPTI-BIOME™ (Bacillus subtilis~     MB40), a probiotic supplement, on bloating, gas and abdominal discomfort symptoms in~     otherwise healthy adults.~   "
47130|NCT02949999|"~     The study is a single-centre, double-blind, placebo controlled, randomized, ascending~     multiple dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamic~     profiles of voclosporin.~   "
47131|NCT02949986|"~     There are many exercise approaches that have demonstrated effectiveness in reducing falls and~     fall risk in community-dwelling older adults. The Otago Exercise Program is one such program.~     The Otago Exercise Program has been tested in four randomized controlled trials and one~     controlled multi-center trial and was found to reduce falls in older men and women. The focus~     of the Otago Exercise Program is on improving strength and balance with a home-based balance~     exercise program. The goal of the current study is to evaluate whether a self-administered,~     tablet-based version of the Otago fall prevention program is both feasible and effective for~     reducing fall risk and improving balance in community-dwelling older adults.~   "
47132|NCT02949973|"~     An exploratory study assessing the ability of biomarkers measured at 8 weeks to predict~     clinical response over 24 and 48 weeks in subjects taking voclosporin 23.7 mg BID in~     combination with standard of care in patients with active lupus nephritis~   "
47133|NCT02949960|"~     The objective of the study is to evaluate the safety and efficacy of DMT210 Gel, 5% compared~     to vehicle control following 28 days of twice-daily topical application to selected target~     lesions in male and female patients with mild to moderate atopic dermatitis (AD).~   "
47135|NCT02949934|"~     The purpose of this study is to determine whether the catechol-O-methyltransferase (COMT)~     inhibitor tolcapone, relative to placebo, reduces alcohol drinking and alcohol cue-elicited~     brain activation and increases brain activation associated with cognitive control as a~     function of a participant's genotype at a polymorphism in the COMT gene.~   "
47136|NCT02949921|"~     The objective of this study is to provide a preliminary assessment of the radiographic~     appearance of Radiesse material that has been injected into the dorsum of the hands.~   "
47139|NCT02949882|"~     There is a relative high prevalence of constipation and antibiotic-associated diarrhoea (AAD)~     in the elderly residents of nursing homes, mainly due to high antibiotic and medication~     usage. Constipation and diarrhoea causes a substantial burden on lives of the frail elderly~     and significantly reduces the quality of life (QoL). In addition, these circumstances lead to~     a higher workload for healthcare workers and treatment of constipation and diarrhoea increase~     costs in healthcare. There are indications that the gastrointestinal microbiome is altered in~     conditions, such as constipation and AAD. Research indicates that probiotics show potential~     in the treatment of constipation, AAD and infectious diarrhoea. Probiotics can restore the~     aberrant gastrointestinal microbiome and thereby possibly treat/prevent constipation and~     diarrhoea in the frail elderly population. To illustrate, a previous pilot study of probiotic~     administration in elderly residents of a nursing home demonstrated a reduced prevalence of~     constipation and diarrhoea stool types and a higher prevalence of ideal stool types during~     the intervention compared to the baseline period. These promising results demand for a~     confirmatory study in this population.~   "
47140|NCT02949869|"~     The reported rate of unsuccessful traditional LP in children (defined as the inability to~     obtain cerebrospinal fluid or obtaining a traumatic puncture) is as high as 50%. Many factors~     affect LP success including provider experience. CSF is obtained by puncturing the~     subarachnoid space (traditionally at the L3-L4 or L4-L5 interspinous process space), and many~     have hypothesized that the width of this space may predict success. Anecdotally, trainees and~     those with less experience, tend to perform the LP too low (caudally), where the subarachnoid~     space tapers, or too laterally (off the midline) resulting in higher failure rates. The~     investigators seek to determine if planned LP insertion sites vary between training and~     attendings, and if so, could the decreased success be explained by smaller subarachnoid~     spaces.~   "
47141|NCT02949856|"~     This study evaluates difference of the endotracheal tube cuff pressure between a tapered-~     versus a cylindrical- shaped cuff after changing from neutral to hyperextension of neck.~      Fifty patients undergoing thyroidectomy are randomly allocated into two groups (tapered- and~     cylindrical-shaped cuff). Endotracheal tube cuff pressure is initially set at 20 cmH20 in the~     supine neutral position and is measured after the change to the neck extension.~   "
47142|NCT02949843|"~     This phase II trial studies how well targeted therapy works in treating patients with~     incurable non-small cell lung cancer with a genetic mutation. Giving drugs that target other~     genetic mutations or other specific proteins may work better when a patient has cancer caused~     by a driver mutation and the treatment that targets that mutation stops working.~   "
47143|NCT02949830|"~     The purpose of this study is to determine the long-term safety, tolerability and~     pharmacokinetics of givosiran (ALN-AS1) in AIP patients~   "
47144|NCT02949817|"~     This study was designed to establish the clinical evidence for effect of video-game based~     rehabilitation therapy system using IMU sensors as a game interface, newly-developed in~     Korea, on upper limb function of children with cerebral palsy. First, the investigators would~     compare the effect of video-game based rehabilitation therapy to conventional occupational~     therapy.~   "
47145|NCT02949804|"~     Almost everyone is aware these days is aware about the risk of smoking. Still many people~     start this habit specially in early life and during college year. We aim to investigate in~     this study if there is a drive to smoke in people with vasovagal tendency to improve their~     symptoms, even if not aware of this. Vasovoagal symptoms are common and include dizziness,~     smoking, sweating, abdominal pain, fatigue and syncope. Some studies have shown correlation~     between smoking and a positive tilt table test which is indicative of vasovagal tendency. By~     collecting the information regarding smoking habit and vasovagal symptoms analysis can be~     done to see if there is correlation between these two factors~   "
47146|NCT02949791|"~     Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) is a~     promising therapy for peritoneal carcinomatosis (PC) of various origins. Rather than the~     pharmacokinetic advantage, the uptake of chemotherapy by tumor tissue has been proposed as~     the best pharmacologic endpoint to assure the efficacy of HIPEC.~      The primary endpoints of the present phase II randomized study are to test whether the~     increased intra abdominal pressure (IAP) during HIPEC could:~        -  enhance the penetration of cisplatin into the residual neoplastic and normal tissues;~        -  elicit changes on pharmacokinetic advantage of cisplatin.~      Secondary endpoints are to evaluate the:~        -  impact of high IAP on intraoperatory hemodynamic and respiratory parameters;~        -  impact on short-term surgical outcomes (in hospital stay, morbidity, mortality).~      Patients affected by PC from colorectal cancer or pseudomyxoma peritonei, submitted to~     complete cytoreduction (residual disease <2.5mm) would be eligible for the study. HIPEC will~     be performed using closed abdomen technique and cisplatin + mitomycin-C. Patients will be~     randomly assigned to HIPEC with low IAP (8-12 mmHg) or high IAP (18-22 mmHg). IAP will be~     measured using bladder catheter. High IAP will be obtained increasing the volume of~     perfusate.~      Thirty-eight patients (19 in each study groups) will be enrolled in 30 months. The randomized~     groups will be stratified according to tumor type.~   "
47147|NCT02949778|"~     Double blinded, randomized, controlled, phase IV intervention trial. Both groups will receive~     a quadratus lumborum Block (QL), using ropivacaine 3.75 mg/mL in the intervention group, and~     sterile sodium chloride in the control group. The aim of study is to investigate the effect~     of a QL Block on the perioperative pain during postbariatric abdominoplasty.~   "
47148|NCT02949765|"~     Anemia and sideropenia are a common effect of untreated celiac disease. In a portion of~     patients a certain degree of hypoferritinemia persist after the diagnosis, despite a good~     compliance and clinical response to gluten-free diet. These patients are usually~     premenopausal women in whom the cyclic menstrual bleeding and the oral iron intake are not~     balanced.~      The aim of the study is to compare the efficacy of a pharmacological therapy, frequently not~     tolerated, and a dietary approach through a iron-rich diet in this subset of patients.~   "
47149|NCT02949752|"~     This is an open label study to prospectively evaluate the effect of adjunct use of~     Aripiprazole, as an agent to improve metabolic profile and induce weight loss in patients~     established on atypical antipsychotics (Olanzapine, Clozapine and Risperidone).~   "
47150|NCT02949739|"~     the investigators general goal is to identify approaches to risk stratification and health~     promotion through lifestyle modification that are acceptable, effective and efficient for~     prevention of T2D in South Asian communities from diverse settings.~   "
47152|NCT02949713|"~     The primary aim of this study is to find out whether it is feasible to conduct a larger study~     looking at the effect of mobile phone text messaging added to motivational interviewing on~     number of women living with HIV infection reporting exclusive or any breastfeeding six months~     post-delivery.~      Secondary aim: In HIV-infected women initiating breastfeeding after giving birth, does~     interactive weekly mobile phone text messaging plus motivational interviewing versus usual~     care, improve self-reported adherence to exclusive or any breastfeeding 6 months~     post-delivery~   "
47153|NCT02949700|"~     The purpose of this research is to see whether metformin can improve the response rate in~     patients undergoing chemotherapy and radiation for squamous cell carcinoma of the oral~     cavity, oropharynx, larynx or hypopharynx. The purpose of this research is also to see the~     effects, good and bad, of metformin therapy for this disease. Researchers will also analyze~     tumor and blood samples from study patients to test and understand the characteristics of~     tumors which respond to metformin.~   "
47154|NCT02949687|"~     Surgical Treatment in Diabetic Patients With Grade 1 Obesity~   "
47155|NCT02949674|"~     Title: Ropivacaine versus Bupivacaine as Preventive Analgesia in Surgical Incision Site In~     Patients With Ankle Fracture Background: Ankle fractures are about 10% of the fractures~     associate to sports and with an incidence of 0.11 of 1000 adult patients. Weber~     classification system divides ankle fractures in three types according to the anatomy of~     lateral malleolus. B fractures starts at tibia pilon. Stable fractures are easily treated in~     conservative way. (12) Unstable fractures are treated surgically with anatomic reduction and~     internal fixation. However, it's been reported that even with successful reduction surgically~     great results are not always achieved. Local wound infiltration blocks the pain in its~     origin, surgical site by itself, without alter motor function. Practically without presenting~     adverse events with this method. it´s accurate for ambulatory surgery.~      Main Objetive: To compare preventive analgesia with local anesthetic in surgical site with~     ropivacaine or bupivacaine in ankle fracture patients treated surgically with open reduction~     and internal fixation.~      Method: Two groups with ankle fractures which will be informed and the patients will sign~     informed consent, after that the patients will be assign to a group (Ropivacaine or~     bupivacaine). The patient will be prepared for surgical treatment according to his doctor. It~     will be applied traditional anesthesia. It will be applied before beginning surgery in~     bupivacaine group 25 mg and in ropivacaine group 37.5 mg at least 10 minutes before starting~     surgery. After that the patient will have the traditional dose of analgesic treatment.The~     group will evaluate the pain with VAS 0-10 at 4,8,12 and 24 hours after surgery. The group~     will register data and will make statistic analysis. It will be elaborated the conclusion an~     elaboration of a report.~      Resources: The group counts with human resources of the group of investigators. The hospital~     has in emergency department almost three patients with ankle fractures each day which require~     surgical treatment. The hospital has x ray service to valuate the ankle fracture and with~     computer system to analyze it. The hospital has the software for statistical analysis.~      Experience: The group is formed with orthopedic surgeons with more than 5 years in treatment~     of ankle fractures. Investigators have the support of pain medicine group in hospital and~     with anesthesia coordinators. Investigators have a group of orthopedic residents which will~     be encharged of ilfiltration wound site.~      Time: September 2016 to February 2017.~   "
47156|NCT02949661|"~     Tracheal resection and reconstruction (TRR) is the treatment of choice for most patients with~     tracheal stenosis or tracheal tumors .The postintubation tracheal stenosis is the common~     indication for (TRR).The immediate postoperative period can be anxiety provoking for some~     reasons such as requirement to maintain a flexed neck, oxygen mask, and surgical pain which~     inadequately treated.~      Bilateral superficial cervical plexus block (BSCPB) is a popular regional anesthesia~     technique for its feasibility and efficacy. The use of regional anesthesia in combination~     with general anesthesia may lighten the level of general anesthesia required , provide~     prolonged postoperative analgesia and reduce the requirements for opioid analgesics~      Local anesthetic infiltration into the surgical incision can relieve pain at the wound site~     after surgery, as part of multimodal analgesic approach.~      Levobupivacaine, is S-enantiomer of bupivacaine, has strongly emerged as a safer~     alternative for regional anesthesia than bupivacaine . Levobupivacaine has been found to be~     equally efficacious as bupivacaine, but with a superior pharmacokinetic profile. Clinically,~     levobupivacaine has been observed to be well tolerated in regional anesthesia techniques both~     after bolus administration and continuous post-operative infusion.~   "
47157|NCT02949648|"~     A mixed method (longitudinal, trajectory and qualitative studies) to provide comprehensive~     evidence on the impact of e-cigarette use on smoking and quitting among smoking youth in Hong~     Kong.~   "
47158|NCT02949635|"~     Three events can be considered of major importance for patients after a hospitalization in an~     AGU: death, hospital readmission, and institutionalization. Current published data do not~     allow the clinician to simultaneously estimate the risk of hospital readmission,~     institutionalization and death of an older patient according to his/her characteristics and~     various complications that occurred during the hospitalization. However, clinicians often~     need to estimate these risks at hospital discharge to adapt their therapeutic choices, their~     proposals post-hospital care, and provide reliable and fair information to the patient and~     his relatives.~      Estimating simultaneously the hazard for each of these three events can be complex. Indeed, a~     death event hinder the observation of re-hospitalization or institutionalization if death~     occurs before these events. The death should be considered a competing risk in these~     analyzes. Hospital readmission may modify the risk of death or institutionalization and~     should be considered as an intermediate factor for these event. This complexity cannot be~     accounted with classical statistical models, like logistic regression models.~      The purpose of this study is to use more appropriate statistical models (multi-state models)~     to better estimate simultaneously the risks of hospital readmission, institutionalization,~     and death of a patient given after hospitalization in AGU, and to show that accuracy of these~     estimations can be improved by taking into account complications that occurred during the~     stay in AGU.~   "
47159|NCT02949622|"~     The aim of this study is to identify the psychological, emotional and lifestyle variables~     that can have an influence on the different components of metabolic syndrome (MetS) and~     develop a program for change lifestyle in this patients.~   "
47172|NCT02949453|"~     Background: Previous suicide attempt is known to be a strong risk factor for repetition and~     repetition is common within the first year after an episode of deliberate self-harm (DSH).~     There has been growing interest in brief interventions for this population that are focused~     on maintaining long-term contact and/or offering re-engagement with services when needed.~     Despite telephone-delivered interventions have shown promising results in suicide reattempt~     prevention, subjective impact of such brief contact interventions and effectiveness~     mechanisms have never been evaluated.~   "
47173|NCT02949440|"~     To investigate the clinical application value of laparoscopic radical right hemicolectomy~     using the caudal-to-cranial approach versus the medial-to-lateral approach by prospective~     randomized controlled clinical study.~   "
47429|NCT02946086|"~     This study aims to investigate the changes induced by HABIT-ILE in impairments, activity and~     participation of children with unilateral CP, as well as neuroplastic changes induces by the~     treatment. Visuospatial deficits will be investigated and the effect of prismatic adaptation~     will be measured.~   "
47160|NCT02949609|"~     After stroke, patients frequently suffer from arm or hand weakness. There are numerous~     rehabilitation methods to stimulate recovery, amongst which mirror therapy (MT). It is~     particularly interesting in cases for which impairment is severe, as many other forms of~     therapy are often impossible.~      During MT, a mirror is placed in the midsagittal plane, so as to hide the impaired limb.~     Thereafter, the subject is asked to move his unimpaired limb while looking at its reflection~     in the mirror, thereby creating the illusion that the contralateral, impaired limb is moving.~      The objective of this study is to better determine the efficacy of MT. The investigators will~     therefore compare recovery of arm function in two groups of patient, that perform a regimen~     of 30 minutes of therapy, 5 times a week, for 4 weeks on top of conventional therapy. One~     group performs MT and the other one performs a therapy in which the same movements are~     performed, but without the use of a mirror, with unrestricted view of both limbs. Allocation~     to each group will be randomized. Arm function will be evaluated by use of a scale before,~     during and after the 4 week period. The assessor for the primary outcome measure will not~     know in which group the patient is. There will be a total of 30 patients included over a one~     year study period.~   "
47161|NCT02949596|"~     Treatment of anal cancer has been always linked to quality of life. Recently, with~     development on radiotherapy technique, toxicities have been lowered with the maintenance of~     adequate rates of disease control. This trial intends to follow patients prospectively with~     questionnaires to evaluate sexual quality of life among patients who are who men who have sex~     with other men and have been subject to concurrent chemoradiotherapy with IMRT technique.~   "
47162|NCT02949583|"~     The mechanical control of supragingival biofilm is accepted as one of the most important~     measures to prevent dental caries and periodontal diseases. Nevertheless, maintaining dental~     surfaces biofilm-free is not an easy task. In this regard, numerous studies researches have~     demonstrated the effectiveness of mouthwashes containing antimicrobial active ingredients~     that prevent and control both supragingival biofilm and gingivitis, specially when used~     adjunctively to mechanical oral hygiene regimens.~   "
47163|NCT02949570|"~     To assess the efficacy of inecalcitol in combination with imatinib in CML patients with~     molecular residual disease on imatinib monotherapy.~   "
47164|NCT02949557|"~     DFDBA is an allograft that possesses osteoconductive and osteoinductive properties. It has~     the potential for osteoinduction due to increased expression of bone morphogenetic protein~     (BMP).Cerabone™ has shown maximum resemblance to human bone with the potential to reconstruct~     bone defects. Decortication is performed as a part of guided bone regeneration (GBR)~     procedure as it enhances the healing process.Therefore a combination of decortication and~     bone graft when applied in periodontal intrabony defect would enhance the regeneration of~     periodontium.~   "
47165|NCT02949544|"~     This study aims to investigate the effects of water immersion and exercise on heart function~     and blood flow in patients with chronic stable heart failure.~   "
47166|NCT02949531|"~     Oxygen is routinely given to patients with common conditions such as COPD and heart failure.~     There is no evidence behind giving oxygen to patients specifically in heart failure due to a~     stiff heart.~      This study aims to explore the effect oxygen has on the ability of patients with chronic~     heart failure and the ability to exercise. Other common variables will be assessed such as~     heart rate and blood pressure to observe the response to varying concentrations of oxygen.~      The concentrations chosen are commonly offered in hospitals and indeed are being delivered~     through standard equipment found in all hospitals in the country.~      It is hoped that studying the effect of short term oxygen on patients with heart failure will~     help to identify the effectiveness of oxygen in longer term therapy for patients who are~     often breathless with a decreased exercise tolerance.~   "
47167|NCT02949518|"~     Enhanced recovery after surgery (ERAS) pathways have been shown to decrease length of stay~     and perioperative complications in a range of surgical specialties. To date, ERAS has not~     been studied in patients presenting for spine surgery. The investigators have recently~     developed an interdisciplinary pathway for spine surgery patients based on the latest~     available evidence and guidelines. The aim of this trial is to compare the investigators ERAS~     pathway with conventional perioperative management in patients undergoing 1-2 level posterior~     lumbar fusion.~   "
47168|NCT02949505|"~     A UK prospective, single-centre feasibility study investigating the effects of exercise~     therapy on functional capacity in patients on the waiting list for liver transplantation.~     Patients will receive a 12-week home prehabilitation program (daily step program; functional~     resistance exercise sessions; telephone health call or virtual clinic). The following will be~     assessed at weeks 0, 6 and 12 weeks: feasibility (recruitment, compliance, safety, patients~     perception), functional capacity (ISWT, SPBT), psychological wellbeing (HADS questionnaire)~     and quality of life (EQ-5D)~   "
47169|NCT02949492|"~     Regulatory T cells (Tregs) suppress cytopathic immune responses and inhibit transplant~     rejection. Our goal is to exploit the Treg suppressive properties to induce transplantation~     tolerance. In contrast to effector T cells, Tregs constitutively express the high affinity~     IL-2 receptor, which makes them exquisitely sensitive to very low-doses of IL-2. We propose~     here to conduct a phase IV clinical trial in which we will test the capacity of low-dose IL-2~     to promote the selective expansion of endogenous Tregs in liver transplant recipients at the~     time immunosuppressive drugs are being discontinued. We expect this will promote Treg~     accumulation within the transplanted liver, shift the balance between effector T cells and~     Tregs, and facilitate the development of operational tolerance in patients unlikely to reach~     this state spontaneously. We expect the trial to start shortly after the initiation of the~     project and to provide robust evidence on the efficacy of IL-2 within 47 months.~   "
47170|NCT02949479|"~     Background: Adverse childhood experience have been described in sexual offenders but the link~     with the offence need to be further investigated. Investigators postulate that one of the~     clinical moderating factors could be dissociative experience, a consequence of these early~     adverse experiences reactivated during the offence. The purpose of the study is to estimate~     the prevalence of clinical dissociation during the offence in a male adult population~     referred to our center for a sexual offence and to explore its correlations with~     epidemiological and clinical data (personal, legal history, psychiatric comorbidities),~     clinical trauma and dissociation, prognosis estimates.~   "
47174|NCT02949427|"~     The human microbiome is composed of unique groups of microorganisms occupying distinct~     habitats distributed throughout the human body. The Human Microbiome Project recently~     evaluated the bacterial composition of the microbiome in 18 (for women) and 15 (for men) body~     sites. Much initial attention in the field of microbiome research has focused on the~     bacterial contribution to a healthy microbiome. However, it is clear that other~     microorganisms, including fungi and viruses, are also distributed throughout the human body~     and serve as functional components of the microbiome.~      The populations of microorganisms residing within the oral and nasal cavities make important~     contributions to human health and disease. These contributions may be especially important in~     immunosuppressed patients, including those patients receiving myelosuppressive chemotherapy~     or undergoing hematopoietic stem cell transplantation. In these patients, organisms typically~     considered as commensals can become pathogenic, either locally or systemically.~      This observational study is primarily undertaken to evaluate the oral and nasal microbiota~     and to define the population of fungal organisms residing within the oral and nasal cavities~     in pediatric oncology patients before and after receiving protocol-directed chemotherapy and~     associated supportive care.~   "
47175|NCT02949414|"~     This is a phase I study to evaluate the safety, efficacy and tolerability of a novel tracheal~     replacement therapy using cadaveric de-cellularised tracheal scaffold and patients' own~     mesenchymal cells isolated from a sample of their bone marrow in patients' who suffer from~     severe tracheal malacia or stenosis.~   "
47176|NCT02949388|"~     This study is designed as a randomized, double blind, parallel group, placebo-controlled~     trial to study the efficacy and safety of two oral doses of Prurisol administered twice daily~     for twelve weeks to subjects with moderate to severe chronic plaque psoriasis.~   "
47177|NCT02949375|"~     Primary objectives:~      To evaluate the change in serum alanine transaminase [ALT] levels from Day 0 to Day 28,~     following daily doses of 4.5 or 6mg of GRI-0621 compared to placebo, in patients with chronic~     liver disease and elevated serum levels of ALT. Serum ALT level will be used as a marker of~     liver inflammation.~      To assess the safety and tolerability of GRI-0621 at these two doses.~      Secondary objectives:~      To assess the change in serum aspartate transaminase [AST] levels from baseline to Day 28,~     following daily doses of 4.5 or 6mg of GRI-0621 or matching placebo, in patients with chronic~     liver disease and elevated serum levels of AST. Serum AST level will be used as a second~     marker of liver inflammation.~      To evaluate the response to 4.5mg GRI-0621 versus 6mg GRI-0621 in terms of the change in~     serum ALT levels from baseline measured at the different trial time points.~      To assess changes in serum cytokeratin 18 [CK-18] levels from baseline to Day 28, following~     daily doses of 4.5 or 6mg of GRI-0621 or matching placebo, in patients with chronic liver~     disease. Serum CK-18 is used as a marker of hepatocyte cell death due to either necrosis or~     apoptosis.~      To measure Natural Killer T lymphocyte [NKT] cell activity at baseline and at Day 28~     following daily doses of 4.5 or 6mg of GRI-0621 or matching placebo.~      To describe the steady-state pharmacokinetics [PK] of GRI-0621 in patients with chronic liver~     disease.~      Exploratory objectives:~      To assess the effect, if any, that the investigational product may have on serum triglyceride~     levels.~   "
47178|NCT02949362|"~     The purpose of this study is to evaluate the safety and efficacy of teduglutide treatment of~     children with short bowel syndrome (SBS) who completed the TED-C13-003 study over a long-term~     period. It will evaluate how these children fared after the TED-C13-003 study ended. This~     study will also offer teduglutide treatment to eligible subjects, regardless of treatment~     received in TED-C13-003.~   "
47179|NCT02949349|"~     This study is designed to compare the safety and efficacy of Mycocep Capsules (Mycophenolate~     Mofetil) and a marketed Azathioprine formulation, Imuran Azathioprine Tablets, in the~     maintenance therapy of lupus nephritis.~   "
47180|NCT02949336|"~     The proposed study is a prospective collection of health related personal data (observational~     study). A total of approximately 10 subjects with traditional medial SIGMA® High Performance~     Partial Knee System and 10 ACL deficient subjects with medial SIGMA® High Performance Partial~     Knee System are analyzed during sitting onto a chair and getting up, deep knee bend, stance~     and swing phase of level walking, downhill walking (ramp descent) and stair descent at least~     12 months post-operatively, in terms of 3D fluoroscopic assessed tibio-femoral motion as well~     as simultaneous skin marker assessed whole leg motion and ground reaction forces. All the~     video-fluoroscopic testing is performed at the Institute for Biomechanics at the ETH Zurich.~     The UKA subjects are recruited based on the inclusion and exclusion criteria.~      The primary objective is to quantify and describe the three-dimensional kinematics for~     patients with a traditional medial SIGMA® High Performance Partial Knee System (functional~     ACL and tibial posterior slope matching the native bone) during these daily activities.~      The secondary objective is to evaluate patients with the same medial UKA implant (SIGMA® High~     Performance Partial Knee System) in an ACL deficient knee, where the UKA was implanted at a~     50% reduced tibial posterior slope relative to the native knee.~   "
47181|NCT02949323|"~     The incidence of nephrolithiasis in children has been reported to increase by approximately~     6-10% annually, and the incidence is currently 50 per 100,000 children with high recurrent~     rate. Investigators aimed to determine the metabolic risk factors in Chinese children through~     metabolic evaluation.~      In order to identify diagnostic criteria of hypocitraturia and hyperoxaluria in western~     country wether adapt to Chinese children, investigators aim to determine normal urine levels~     of oxalate and citrate in children without kidney stone.~   "
47182|NCT02949310|"~     Breast cancer surgery is known to cause severe acute postoperative pain, which can persist~     for a long time. The investigators administered nefopam preventively to patients undergoing~     total mastectomy or modified radical mastectomy with axillary lymph node dissection or~     sentinel lymph node biopsy, and evaluated its efficacy on acute and chronic postoperative~     pain.~   "
47183|NCT02949297|"~     A prospective clinical evaluation of the effectiveness of the Ovation Alto Abdominal Stent~     Graft System when used in the treatment of subjects with abdominal aortic aneurysm (AAA).~   "
47220|NCT02948816|"~     Participants will be exposed to 3 conditions, in random order:~        1. A Facebook page where 70% of posts are related to food.~        2. A Facebook page where only 20% of posts are related to food.~        3. A control condition (colouring quietly).~      During each of the above conditions participants will be provided with identical snacks. The~     snacks will be weighed before and after each condition, to determine whether there is a~     change in food intake across the 3 conditions.~   "
47184|NCT02949284|"~     This randomized phase II trial studies how well androgen receptor antagonist ARN-509 works~     with or without abiraterone acetate, gonadotropin-releasing hormone agonist, and prednisone~     in treating patients with high-risk prostate cancer undergoing surgery. Androgen can cause~     the growth of prostate cancer cells. Hormone therapy using androgen receptor antagonist~     ARN-509, abiraterone acetate, and gonadotropin-releasing hormone analog (GnRH agonist) may~     fight prostate cancer by lowering the levels of androgen the body makes. Prednisone may~     either kill the tumor cells or stop them from dividing. Giving androgen receptor agonist~     ARN-509 with or without abiraterone acetate, GnRH agonist and prednisone may work better in~     treating patients with prostate cancer.~   "
47185|NCT02949271|"~     The aim of this prospective, doubled-blinded randomized study is to compare two modes of~     epidural analgesia delivery, programmed intermittent epidural boluses (PIEB) versus~     continuous epidural infusion (CEI) with patient controlled epidural analgesia (PCEA) dosing,~     for providing labor epidural analgesia. The primary outcome will be the volume of local~     anesthetic received through PCEA. Secondary outcomes will measure time to first PCEA bolus,~     labor pain scores, degree of motor blockade, mode of delivery, PCEA attempts and ratio of~     successful to unsuccessful attempts, frequency of hypotension, duration of first and second~     stages of labor and level of patient satisfaction. The investigator plans to enroll 120~     nulliparous participants at 2-5 com cervical dilation, with 60 patients to each arm. The~     subject will be assigned to receive either delivery of epidural medication ropivacaine 0.1%~     with fentanyl 2mcg/mL with PIEB + PCEA dosing method or CEI + PCEA. Continuous data will be~     analyzed using the Kruskal-Wallis test or t-test as appropriate. Categorical data will be~     analyzed using Chi-square test or Fisher's exact test as appropriate.~   "
47186|NCT02949258|"~     Scirrhous gastric cancer, also known as linitis plastic or Borrmann type 4, is an aggressive~     tumor with an extremely poor prognosis. Aggressive surgical procedures and adjuvant~     chemotherapies have not improved the survival rate. The purpose of this study is to determine~     whether neoadjuvant Chemotherapy with SEEOX regimen via intra-arterial and intravenous~     administration are effective in the treatment of Borrmann type 4 gastric cancer.~   "
47187|NCT02949245|"~     272 subjects with high risk adult spinal deformity requiring surgical correction were~     enrolled in the previous prospective multi-center international Scoli-RISK-1 study. High~     risk patients were defined by either their diagnoses and/or the type of surgical~     intervention as listed in the inclusion criteria. Neurological complications in the form of~     new motor and sensory deficits were monitored prospectively in all patients at hospital~     discharge, at 6 weeks (± 2 weeks), 6 months (± 2 months) and 24 months (± 2 months) after the~     surgery. The relationship to the surgical intervention was assessed in all new deficits.~      Regression analyses were used to evaluate the association between patient demographics,~     co-morbidities, treatment history, spinal deformity characteristics, surgical~     characteristics, non-neurologic complications and pre-surgical status to occurrence of a~     neurologic deficit after surgery.~      All enrolled Scoli-RISK-1 participants will be re-consented and asked to return for a 5 year~     FU visit.~   "
47188|NCT02949232|"~     Treatment with prednisolone can be used as a proof of concept to investigate the possibility~     of immune modulation as a treatment for schizophrenia. It is expected that daily treatment~     with prednisolone in addition to antipsychotic treatment reduces psychotic symptoms and~     improves cognition, as compared to placebo. The investigators propose to investigate the~     effects of administering the corticosteroid prednisolone versus placebo in addition to~     standard antipsychotic medication in patients with early stage schizophrenia or related~     disorders, hypothesizing that a decrease in the overall low-grade cerebral inflammation due~     to prednisolon treatment will be expressed as a decrease in overall symptom severity.,~     Secondly, addition of prednisolone is hypothesised to slow down cognitive deterioration in~     recent-onset psychosis patients. Finally, the investigators aim to determine whether indirect~     immunological parameters of the hypothesised low grade inflammation status in schizophrenia~     are shifted due to the addition of prednisolone.~   "
47189|NCT02949219|"~     This phase II trial studies how well pembrolizumab works in treating patients with small~     bowel adenocarcinoma that has spread to other places in the body or that cannot be removed by~     surgery. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of~     tumor cells to grow and spread.~   "
47190|NCT02949206|"~     The purpose of this study is to assess the safety and tolerability of JNJ-64179375 in Part 1~     (Intravenous dose) and Part 3 (Subcutaneous dose) and potential for reversibility of~     JNJ-64179375 induced Pharmacodynamic effects on coagulation parameters and platelet function~     (Part 2) in healthy male participants.~   "
47191|NCT02949193|"~     This is a randomized, double-blind, active-controlled, phase III clinical trial to~     investigate the efficacy and safety of evogliptin when added to ongoing metformin monotherapy~     in patients with type 2 diabetes who have inadequate glycemic control~   "
47192|NCT02949180|"~     Prospective, blinded, multicenter international trial to test the Preventicus Heartbeats App~     in a prospective cohort.~   "
47193|NCT02949167|"~     Approximately 24,000 women attend a follow-up care program after end of primary treatment for~     breast cancer (BC) in Denmark. There is no well-conducted, larger randomized controlled~     trials (RCT) outlining a gold standard for follow-up programs ensuring early detection of~     recurrence, good management of symptoms and cost-effectiveness. The primary aim of this~     randomised, controlled trial is to test whether a nurse-led individually tailored symptom~     management program (MyHealth) will significantly reduce reported symptoms among BC patients~     following primary treatment compared to physician-led scheduled follow-up. Secondary, the~     investigators will examine patient activation (self-management), anxiety, depression, fear of~     recurrence, work ability, time to recurrence, overall survival, health behavior changes,~     health care utilization and financial costs in the two arms.~      The MyHealth program provides patients with a nurse-led education focusing on management of~     symptoms, an electronic platform to report symptoms to the nurses and support in symptom~     management and navigation of patients to appropriate health care services.~   "
47194|NCT02949154|"~     A retrospective study investigating the relationship between FDG-PET uptake and LDH levels.~   "
47221|NCT02948803|"~     The aim of this smartphone-based intervention study is to determine whether a newly developed~     app is effective in promoting an active lifestyle in low educated working young adults.~   "
47195|NCT02949141|"~     This study is designed to evaluate the use of lung ultrasound compared to chest x-ray to~     diagnose pneumonia in Nepal. Given the ease, portability, and relative ease of teaching~     ultrasound, this would be potential technology available for many clinicians throughout Nepal~     to use for adult and pediatric patients presenting with suspected pneumonia. This would be~     especially useful in remote areas where clinicians have limited access to x-rays. Despite its~     utility, use of ultrasound to diagnose pneumonia in resource-limited settings like Nepal has~     not yet been studied. Therefore, this study is designed as a prospective, clinical diagnostic~     study to evaluate patients presenting with suspected pneumonia using diagnostic imaging of~     beside ultrasound compared with chest x-ray using computed tomography as the gold standard~     for diagnosis of pneumonia.~   "
47196|NCT02949128|"~     The purpose of the study is to assess the efficacy of ALXN1210 to control disease activity in~     adolescent and adult patients with aHUS who have not previously used a complement inhibitor.~   "
47197|NCT02949115|"~     Aside from aging, numerous factors increase the risk for developing cardiovascular disease~     (CVD) including diet and nutrition. High-fat meal consumption induces postprandial vascular~     endothelial dysfunction and other cardiometabolic disturbances (e.g. dyslipidemia and~     hyperglycemia) in normal weight individuals and is exacerbated in overweight/obese~     individuals. These postprandial responses are likely largely due to activation of~     pro-inflammatory and pro-oxidant pathways. Given that much of the day is spent in the~     postprandial state, this may further impair cardiovascular health in aging overweight/obese~     individuals. Interventions that attenuate these responses are needed. Red beetroot (Beta~     vulgaris L.) is an excellent source of bioactive compounds including nitrate, flavonoids,~     phenolic acids, betalains, carotenoids, and ascorbic acid. These bioactive compounds and~     their metabolites have been shown to have antioxidative, anti-inflammatory, and~     cardiovascular-protective effects. These effects, particularly the cardiovascular-protective~     effects, have been primarily attributed to its high content of nitrate since it is converted~     to nitric oxide independent of the vascular endothelium via the enterosalivary~     nitrate-nitrite-nitric oxide pathway. However, red beetroot juice contains a number of other~     potentially beneficial bioactive compounds and few studies have aimed to determine whether~     these compounds work independently, additively, or synergistically in exerting these effects.~     Given the findings of previously conducted research in the broad area of red beetroot juice~     consumption and human health, it can be suggested that: 1) acute red beetroot juice~     consumption may prevent or attenuate the adverse postprandial responses to consuming a~     high-fat meal in individuals with exaggerated responses; and 2) chronic consumption of red~     beetroot may improve underlying factors contributing to these exaggerated responses.~     Accordingly, this project aims to: 1) investigate the efficacy of acute and chronic whole red~     beetroot juice consumption compared with its bioactive components in attenuating postprandial~     vascular endothelial dysfunction and adverse cardiometabolic responses to a high-fat meal;~     and 2) to gain insight into the underlying mechanisms responsible.~   "
47198|NCT02949102|"~     The purpose of the research is to test whether a gymnemic acids (GA) lozenge will reduce~     reward region response to intake of high-sugar food and ad lib candy intake and whether the~     GA lozenge reduced reward region response to anticipated intake of high-sugar food and~     high-sugar food pictures relative to a placebo lozenge.~   "
47199|NCT02949089|"~     This study intends to provide information on the safety and tolerability of repeated oral~     doses of ACH04. A phase I, single-center, first in human, open-label, dose escalation study~     of ACH04 to assess the safety and tolerability in healthy adults subjects is selected to best~     address the study goals.~   "
47200|NCT02949076|"~     Cancer and its treatment can have profound effects on skeletal muscle, the most~     well-recognized being atrophy, weakness and diminished oxidative capacity. These adaptations~     negatively impact quality of life, treatment decisions and survival. Despite these~     consequences, the factors promoting these adaptations remain poorly defined and understudied~     in human patients. To address this gap in knowledge, our goal in this study is to examine the~     role of muscle disuse as a regulator of muscle size and function in human cancer patients~   "
47201|NCT02949063|"~     A mixed methods design was used to explore the outcomes of a 6-week, occupational therapy-led~     Comfortable Cafeteria program designed to build capacity of cafeteria supervisors to create a~     positive mealtime environment so that all students can successfully participate in and enjoy~     their meal and socialization with peers.~   "
47202|NCT02949050|"~     Patients demonstrated allergic to corn pollen and timothy grass pollen (by allergy testing)~     who have undergone 1 to 2 years of subcutaneous allergen immunotherapy (SCIT) containing~     timothy grass extract with moderate symptomology (as documented via rhinitis symptom score~     surveys) will constitute the treatment group. Those who previously chose not to undergo SCIT~     who have documented symptomology and are skin test positive to corn pollen will constitute~     the control group. Prospective symptom score analyses and retrospective quality of life~     assessments (RQLQ) will be the primary and secondary efficacy outcome measures.~   "
47203|NCT02949037|"~     Multi-site feasibility study designed to assist type-2 diabetes patients in self-care~     activities. The study includes Bluetooth-enabled medical devices (i.e. scales, blood pressure~     cuffs, glucometers, and activity monitors) for both intervention and control groups. Those in~     the intervention group will have the devices linked too a mobile health care environment that~     provides key benefits that include: device data trending, reinforcing tailored behavioral~     messages, and enhanced communication with the clinic.~   "
47204|NCT02949024|"~     This study is designed to demonstrate the safety and tolerability of suprachoroidal CLS-TA~     alone or in combination with intravitreal aflibercept in subjects with diabetic macular edema~     associated with diabetes mellitus.~   "
47205|NCT02949011|"~     The primary objective of this study is to evaluate the efficacy of a single, oral dose of~     Baloxavir Marboxil compared with placebo by measuring the time to improvement of influenza~     symptoms in patients with influenza presenting within 48 hours of symptom onset.~   "
47216|NCT02948868|"~     This study will correlate MA-abstinence outcomes from an 8-week contingency management (CM)~     program of voucher- based incentives using an escalating schedule that has been successfully~     implemented as an adjunct to MA treatment by the investigators collaborators in the United~     States. Pre- and post- treatment neuroimaging and neurocognitive assessments will assist in~     identifying structures and/or processes that may represent targets for development of novel~     behavioral and/or medication therapies.~   "
47217|NCT02948855|"~     Initially investigators will find LncRNA which to be able to affect Notch2 signaling pathway;~     then confirm the relationship between Notch2 and LncRNA, and analysis the regulation mode of~     LncRNA to Notch2 signaling pathway, and to observe the correlation between LncRNA and thymoma~     complicated with autoimmune diseases.~   "
47218|NCT02948842|"~     The purpose of this study is to assess the efficacy of clostridium histolyticum collagenase~     (XIAFLEX®) in treating urethral strictures.~   "
47219|NCT02948829|"~     The purpose of this study is to assess the cellular immune responses following 2 doses of~     tetravalent dengue vaccine candidate (TDV) in 4 to 16 years' healthy participants.~   "
47206|NCT02948998|"~     Hypertrophic Cardiomyopathy (HCM) is the most common hereditary heart disease with high~     mortality. Heart failure is the most common complication (about 50% incidence) in these~     patients. However, it is lack of efficiency medicine to treat heart failure for HCM patients.~      Recent studies found fibrosis was common in HCM patients and it was progressive with aging.~     Late gadolinium enhancement cardiac magnetic resonance (LGE-CMR) is a gold standard to~     measure the left ventricular(LV) fibrosis extent and been proven to be useful in HCM~     patients.~      Aldosterone plays an important role in the development of fibrosis. Meanwhile, a few studies~     suggested that aldosterone might participate the development of fibrosis in HCM patients.~     Spironolactone, a mineralocorticoid receptor antagonist, has been proven its effect on~     inceasing the survival of the heart-failure patients with the eject fraction lower than 35%.~      Thus, the investigators hypothesize that fibrosis is one important reason of heart failure~     for HCM patients. The purpose of this study is to investigate whether small dosage and early~     prescription of spironolactone to HCM patients can relieve and/or reverse the fibrosis~     progress and improve patients' symptoms.~      This study is a multicenter, randomized, controlled and open-label study being conducted in 4~     centers in Shanghai, China. The primary objective of the study is to evaluate the efficacy of~     spironolactone on relieving the LV fibrosis in HCM patients. This study plans to recruit 260~     participants with definite HCM diagnosis. Then these participants will be randomized to two~     groups-- control group (not taking spironolactone) and spironolactone group (taking 20mg~     spironolactone orally and daily). LGE-CMR, echocardiography, 24-hour Holter,~     electrocardiography (ECG), and blood test (including hemoglobin, creatitine, potassium, liver~     enzymes, proBNP, TnT, angiotensin and aldosterone) will be performed before random allocation~     and after 2 years. LGE-CMR will be used to measure the extent of fibrosis in LV. The extent~     of LGE+% (the area showing LGE divided by the total area) before and after 2-year experiment~     and the increase of LGE+% after 2-year experiment will be compared between control and~     spironolactone groups. Meanwhile, symptoms, New York Heart Association classification of~     cardiac function, arrhythmia, proBNP and TnT etc. will be compared between two groups.~   "
47207|NCT02948985|"~     Evaluation of individual peripheral blood circulating tumor cells combined with tumor marker~     detection of efficacy of chemotherapy in patients with advanced colorectal cancer: A~     observational clinical trial~   "
47208|NCT02948972|"~     The ENDOFERT Study is an open, multicenter, randomized, parallel-group, controlled trial.~     This study includes patients presenting colorectal DIE and infertility. Patients will be~     randomized in two parallel-groups; one group underwent complete surgery of colorectal DIE~     prior to ART and the other group underwent ART alone (ratio 1:1)~   "
47209|NCT02948959|"~     Primary Objective:~      To evaluate the efficacy of dupilumab in children 6 to <12 years of age with uncontrolled~     persistent asthma.~      Secondary Objectives:~      To evaluate in children 6 to <12 years of age with uncontrolled persistent asthma:~        -  The safety and tolerability of dupilumab.~        -  The effect of dupilumab in improving patient-reported outcomes (PROs).~        -  The dupilumab systemic exposure and incidence of anti-drug antibodies.~        -  To explore the association between dupilumab treatment and pediatric immune responses to~          vaccines: any vaccination for tetanus, diphtheria, pertussis and/or seasonal~          trivalent/quadrivalent influenza vaccine.~   "
47210|NCT02948946|"~     The purpose of this study is to evaluate how well an investigational blood test performs. The~     study will look at the sensitivity and specificity of a blood-based multitranscriptome assay~     (NETest).~   "
47211|NCT02948933|"~     The aim of this study is to evaluate the safety profile of Dengvaxia® when used in the~     real-world immunization setting~      Primary Objective:~        -  To measure the incidence of selected adverse events (AEs) and serious AEs (SAEs)~          occurring over a period of six (6) months after each Dengvaxia® dose administration;~        -  To quantify the association between Dengvaxia® and each of the selected AEs and SAEs for~          which a risk window after vaccination can be defined, using estimates of relative risk~        -  To monitor the occurrence and frequency of hospitalized dengue disease as well as any~          other SAEs leading to hospitalization or death, including new and previously~          unrecognized SAEs, following Dengvaxia® administration on a longer term (up to 5 years~          after the first Dengvaxia® dose administration.~      Secondary objectives:~        -  To identify risk factors for hospitalized dengue disease (severe or not) among subjects~          vaccinated with Dengvaxia®;~        -  To describe the frequency of hospitalized dengue disease and/or other SAEs or selected~          AEs according to the number of Dengvaxia® doses and/or interval between doses.~   "
47212|NCT02948920|"~     A prospective double-blinded randomized controlled study to determine efficacy of ephedrine~     in preserving core temperature in patients under neuraxial spinal anesthesia for knee~     arthroscopic surgery.~   "
47213|NCT02948907|"~     Several benign and malignant diseases are associated with hilar and mediastinal~     lymphadenopathy. Endobronchial elastography that is an imaging procedure used for the~     visualization of tissue elasticity and Tissue Harmonic Imaging (THI) might be useful for~     the differentiation of benign and malignant lymph nodes.~   "
47214|NCT02948894|"~     Primary aim: The MOSAIC trial aims to assess the impact of a mandibular advancement device~     (MAD) on Apnea-Hypopnea Index (AHI) in Asian patients with Heart Failure with reduced~     Ejection Fraction (HFrEF) and obstructive sleep apnea (OSA). The investigators hypothesize~     that the AHI was 60% lower after 3-month treatment with MAD than with sham MAD.~      Secondary aims: The investigators also aim to determine i. the interaction between ethnicity~     (Chinese, Malay, Indians) and the effects of MAD in lowering AHI; ii. the effect of MAD on~     cardiac remodeling (LVEDVI assessed by cardiac magnetic resonance imaging [CMR]); iii. the~     characteristic craniofacial skeletal anatomy (using coned beam computed tomography [CT])~     associated with OSA in Asian patients with HFrEF; iv. the association between self-reported~     adherence to MAD and cardiac remodeling; v. the effects of MAD on biomarkers of HF~     (N-terminal pro-B-type natriuretic peptide [NT-proBNP],high sensitivity cardiac troponin T~     [hs cTnT], high-sensitivity C-reactive protein [hs-CRP], and ST2);~      Rationale: OSA is associated with incident HF. The investigators will study Asian patients~     because a body of evidence suggests mechanisms for OSA differ between Asians and Caucasians.~     While obesity is the major contributing factor in Caucasians, craniofacial skeletal anatomy~     (short mandible, maxilla, and cranial base and a large mandibular volume) plays an important~     role in the development of OSA among Asians. Using cone beam CT, it has been shown that~     Asians have shorter mandibular, maxillary, and cranial base lengths and a greater mandibular~     volume compared with Caucasians. Using a MAD to adjust maxillary-mandibular juxta-positioning~     to maintain a patent airway may be an ethnic-specific approach to treat OSA in Asians.~   "
47215|NCT02948881|"~     The purpose of this study is to estimate the effect of oral Boniva (ibandronate sodium)taken~     once monthly versus placebo on bone quality and strength at the hip at one year.~   "
47222|NCT02948790|"~     The aim of this study is to assess the auditory nerve functionality with an intraoperative~     approach following a surgical removal of acoustic neuroma in patients with severe to profound~     sensorineural hearing disabilities.~   "
47223|NCT02948777|"~     Postprandial lipemia is highly prevalent in type 2 diabetes subjects even with normal fasting~     triglyceride values. Humans are mostly in a postprandial rather than in a fasting state and~     therefore non-fasting triglyceride values reflect more accurately the continuous exposure of~     arterial wall to the substantial cholesterol load. Evolocumab lowers blood LDL-cholesterol.~     This study evaluates the effect of evolocumab on postprandial lipid metabolism in type 2~     diabetes. All participants in this study receive evolocumab treatment.~   "
47224|NCT02948764|"~     The main purpose of the study is to evaluate the potential of a minimal invasive,~     vacuum-assisted biopsy (VAB) to reliably diagnose a pathological complete response (pCR) in~     the breast after neoadjuvant chemotherapy (NACT) in breast cancer patients.~      The study is designed as a multicenter, confirmative, one-armed,~     intra-individually-controlled, open, diagnostic trial, in which we aim to confirm the~     applicability of preoperative VAB in patients after NACT. Furthermore, we aspire to quantify~     the rate of concordant pathological findings (pCR yes / no) in biopsy and surgical specimen.~   "
47225|NCT02948738|"~     Children with asthma are admitted for asthma attacks very frequently in the U.S. The families~     and children are given basic education about asthma but studies are needed to improve this~     education so that it makes a meaningful difference in health outcomes and asthma care. This~     study compares two inpatient education models for children hospitalized with asthma.~   "
47226|NCT02948725|"~     Based on the current state of knowledge and gaps in the literature we will conduct an~     intervention study to explore novel treatment and rehabilitation of patients at Royal~     University Hospital (RUH) with motor deficits following stroke. This project has the~     following objectives:~        1. To determine if cross-education, in addition to standard rehabilitation leads to better~          recovery of upper limb function for stroke patients with hemiparesis.~        2. To incorporate functional brain activation as measured by functional magnetic resonance~          imaging (fMRI) to examine the neural mechanisms associated with changes in motor~          function of the paretic arm post-stroke.~        3. To use diffusion tensor imaging (DTI) tractography to measure connectivity and examine~          the extent to which white matter tract thickness correlates with preserved motor output~          in patients post-stroke.~   "
47227|NCT02948712|"~     The purpose of this study is to help adolescents and young adult cancer survivors address~     their psycho-social needs during the transitional period. The transitional period begins at~     completion of cancer treatment and continues throughout that first year. Patients often~     report this period can be difficult and distressing in many areas of life. This study will~     use a simple tool to measure, on a regular basis, the level of distress a young adult may be~     feeling. Based on this assessment additional mental health support and intervention can be~     recommended to help cancer survivors cope and enhance their feelings of well-being.~   "
47228|NCT02948699|"~     The chemo-radiotherapy for the local advanced nasopharyngeal carcinoma patients will induce~     the mucosal ulcer and damage salivary glands. Consequently, it can disturb the nutrition~     conditions and clinical outcomes of patients. This research tries to evaluate the nutrition~     status at the baseline, before and after radiotherapy, during the follow-up by the body mass~     index, hematological indexes, immunological indexes, and nutrition questionnaires including~     PG-SGA and NRS 2002. Through the evaluation of two different nutritional interventions, the~     investigators aim to find an optimized assessment model and the best nutrition support~     patterns.~   "
47229|NCT02948686|"~     Treatment clinical trial, randomized, controled, parallel, double-blinded, with four groups,~     that aims to evaluate the best application strategy when using a new Universal Adhesive~     system, Ambar Universal (FGM, Joinville, Brazil). Volunteers will be selected and~     recruited,following inclusion criteria and pre-established exclusion. All volunteers will be~     informed and sign a term of clarification and consent. 38 enrolled patients will receive four~     Class V dental restorations, made in four different ways, one from each experimental group,~     using the same universal self-etching adhesive system, which is the tested material in this~     study. Non-carious cervical lesions will receive the applied adhesive system in 4 different~     protocols separated by groups. Group Self Etching (SET) (control): no conditioning, the~     adhesive system will be used in 55 teeth, according to the manufacturer's instructions, in~     the self-etching mode. The adhesive system will be brushed during 10 seconds in the cavity,~     will be air-dried during 5 seconds, brushed again during 10 seconds, air-dried during 10~     seconds and activated during 10 seconds with Light Emission Diode (LED) light; Group SEE~     (Selective enamel etching): 37% phosphoric acid will be applied during 15 seconds, only in~     enamel in 55 teeth. This acid will be removed using water, the cavity will be air-dried, and~     then, the adhesive will be applied according to the manufacturer's instructions, as described~     in group SET; Group SETT (Self-Etching with extended time): Similar to Group SET, but during~     the 2 applications, the adhesive systems will be brushed during 20 seconds, and not during 10~     seconds as described in Group SET; Group SETL (Self-Etching with extended number of layers):~     The adhesive system will be applied as describe in Group SET, but the researchers will apply~     4 layers, and not 2 layers, as described in Group SET. After applying the adhesive, the~     restorations will be made with composite resin, and evaluated every 6 months for pain~     assessment, shape, staining or recurrent caries, using scores. To determine in which group~     each tooth will be enrolled, the authors will randomize the teeth.~   "
47230|NCT02948673|"~     Objectives: The research focus of the study is the production of reactive oxygen species~     (ROS) in patients with type 2 diabetes (T2D) in response to glutathione (GSH) supplementation~     and in response to acute exercise.~      Oxidative stress is suggested as a possible causative factor in the pathophysiology of~     skeletal muscle insulin resistance. GSH is the most abundant endogenous antioxidant in the~     cell and thus, a crucial protector against oxidative stress and insulin resistance. It has~     been found that patients with T2D have a decreased level of GSH in plasma and that 1 h GSH~     infusion improves skeletal muscle glucose uptake by ~25% and the redox environment in~     patients with T2D. Therefore, we want to investigate the effect of 3 months of GSH~     supplementation on skeletal muscle insulin sensitivity and mitochondrial ROS production in~     patients with T2D and healthy controls.~      Hypothesis: Oral GSH supplementation will improve skeletal muscle insulin sensitivity in~     patients with T2D and this effect will be linked to a reduced mitochondrial ROS production in~     the skeletal muscle.~      In contrast to the link between oxidative stress and insulin resistance, ROS produced in~     response to exercise is an important physiological stimulus as it is suggested to play a key~     role in the beneficial mitochondrial biogenesis observed in response to training. It has been~     reported that some patients with T2D have a diminished mitochondrial biogenesis in response~     to training, but the reason for this defect is not known. We want to investigate the link~     between exercise-stimulated ROS production and the mitochondrial biogenesis response in~     patients with T2D and healthy controls in response to acute exercise at two different~     intensities.~      Hypothesis: Considering the pathological condition of T2D skeletal muscle (i.e. high chronic~     ROS level), we speculate that a lower exercise intensity, leading to a lower~     exercise-stimulated ROS production is a more optimal stimulus (i.e. not to high) for~     mitochondrial biogenesis in patients with T2D.~   "
47231|NCT02948660|"~     The research contains three parts. Part 1: To explore the evaluating and prognostic values of~     electroencephalography sleep cycle combined with the serum melatonin and orexin level of~     patients with disorders of consciousness; Part 2: To assess the efficacy of the~     wake-promoting function of zolpidem tartrate in comotase patients; Part 3: To assess the~     efficacy of the wake-promoting function of melatonin in comotase patients.~   "
47258|NCT02948309|"~     In this study a mistletoe preparation (Iscador Qu) is added to standard therapy in inoperable~     pancreatic cancer in order to evaluate effect on overall survival and health-related quality~     of life. Half of participants will take subcutaneous injections with mistletoe in addition to~     standard therapy (palliative chemotherapy or best supportive care); the other half will~     receive a placebo and standard therapy.~   "
47259|NCT02948296|"~     The goal of this study is to evaluate the efficacy of two promising brain stimulation~     treatment protocols designed to decrease the brain response to alcohol cues among heavy~     alcohol users.~   "
47232|NCT02948647|"~     This dietary intervention aims at developing a more personalized and targeted treatment for~     NAFLD in Hispanic children and adolescents who are GG for the PNPLA3 variant. The~     investigators previous publications have shown that this particular demographic has a greater~     than 2-fold higher liver fat compared to GC and CC individuals. They have also demonstrated a~     significant gene*dietary sugar interaction with a significant association between liver fat~     and dietary sugar intake in GG subjects with no such association in GC or CC individuals.~     These studies suggests that different dietary strategies may have differential effects on~     reducing liver fat, depending on PNPLA3 genotype. To confirm this, the investigators will~     complete a clinical trial in 120 overweight and obese Hispanic children (12 - 18 years) with~     clinically verified NAFLD who will be randomized to one of two 12-week interventions:~      Group 1 (standard of care control group): Dietary intervention focused on healthy eating~     (n=60; 30GG + 30GC/CC)~      Group 2 (standard of care + sugar reduction): Dietary intervention based on healthy eating~     and sugar reduction focused on reduction of sugary beverages and added sugar towards a goal~     of 10% of daily calories (n=60; 30GG + 30GC/CC)~      The following outcomes will be measured before and after intervention: Total liver fat~     fraction, and visceral and subcutaneous abdominal adipose tissue volume by magnetic resonance~     imaging (MRI); liver fibrosis by magnetic resonance elastography (MRE); total body fat by~     DEXA; liver enzymes, fasting insulin, glucose, lipids, free fatty acids and inflammatory~     markers, gut microbiome, and insulin and glucose response to an oral glucose challenge. The~     investigators hypothesize that liver fat fraction, liver fibrosis, and metabolic outcomes,~     such as fasting and 2h-glucose and insulin, and inflammatory biomarkers, will show~     significantly greater improvements with sugar reduction relative to control. In addition, the~     investigators also hypothesize a treatment*genotype interaction whereby the reduction in~     liver fat will be significantly greater in GG relative to CC/CG subjects.~   "
47233|NCT02948634|"~     The purpose of this study is to examine the use of low level therapeutic laser (LLLT) for its~     effects on pain, fatigue, and physical function in individuals with fibromyalgia.~   "
47234|NCT02948621|"~     The endoscopic sleeve gastroplasty allows stomach size reduction through an endoluminal~     suture approach without any incision. It could reduce the complications associated with~     current surgical techniques while obtaining the target gastric restriction, weight loss,~     comorbidities and quality of life improvement.~      The primary objective of this study is to assess weight loss after endoscopic sleeve~     gastroplasty in patients with morbid obesity.~   "
47235|NCT02948608|"~     The objective of the study is to investigate extra-articular manifestations, pain mechanisms,~     patient-reported outcomes, comorbidities and association between these conditions in patients~     with spondyloarthropathy (SpA) treated with Biologics. Further, to assess the predictive~     value of baseline pain profile on treatment outcome after ≥ 3 months.~   "
47236|NCT02948595|"~     The long term goal of our research is to develop a curriculum for Obstetrics and Gynecology~     resident physicians that regularly employs use of video assessment to improve surgical~     skills. Regular use of video feedback may enable improved self-assessment and allow for~     formal documentation of proficiency. The overall objective is to compare the use of video~     feedback to use of structured verbal feedback in the simulated task of laparoscopic vaginal~     cuff closure.~   "
47237|NCT02948582|"~     The study assessed the safety and ability of an orally inhaled medicine [i.e., Glycopyrrolate~     Inhalation Solution = GIS] to improve airflow in the lungs when delivered using an eFlow~     nebulizer in 42 patients with Chronic Obstructive Pulmonary Disease (COPD). Each patient~     randomly received several, single doses of GIS, or placebo, separated by approximately 1 to 2~     weeks. After the dose was given, lung airflow was measured over 24 hours and blood was~     collected to measure how much GIS was in the bloodstream. The study was conducted to find the~     once-a- day GIS dose that produced the highest improvement in lung airflow using the eFlow~     nebulizer.~   "
47238|NCT02948569|"~     Metabolic syndrome increases the risk for development of heart disease. Another condition~     associated with metabolic syndrome is fatty liver disease which is also referred to as~     nonalcoholic fatty liver disease (NAFLD). Recently, drugs that block fatty acid synthesis~     have been developed to treat cancer. These drugs are now being considered for the treatment~     of NAFLD. A research test designed to measure liver fatty acid synthesis involves consumption~     of a sugary solution and measurement of blood fats over a six-hour period. The present study~     will test the drug 3-V Bioscience-2640 in healthy subjects with characteristics of the~     metabolic syndrome before and after 10 days of treatment to determine if 50 mg/d~     significantly reduces liver fat synthesis and lowers liver fat storage.~   "
47239|NCT02948556|"~     The purpose of this study is to identify daily activity patterns, negative life events and~     autonomic abnormalities that may be related to non-improvement in myalgic~     encephalomyelitis/chronic fatigue syndrome (ME/CFS). For both naturalistic studies and~     behavioral intervention trials, roughly 50% of patients report worsening or unchanged~     illness. The proposed four year study would be the first to look at the relation between~     illness non-improvement, patient activities at home and autonomic function. Our long-range~     goal is to identify physiological signals and activity patterns that predict non-improvement~     and relapse and develop a self-management program that prescribes improvement-linked~     behaviors and discourages non-improvement activities.~   "
47240|NCT02948543|"~     Open label, randomised phase 3 trial of the addition of Mitomycin C to BCG as adjuvant~     intravesical therapy for high-risk, non-muscle-invasive bladder cancer. The study aim is to~     compare disease-free survival between treatment arms: BCG alone versus Mitomyicn C in~     addition to BCG.~   "
47241|NCT02948530|"~     Classically lung elastance and transpulmonary pressure are measured from the difference in~     tidal variations of airway pressure subtracted by tidal variations i esophagus pressure~     divided by the tidal volume. This requires the presence of a esophageal balloon catheter~     which is cumbersome and costly. In this study values obtained as described above are compared~     to values obtained with a new method in which a stepwise increase in positive endexpiratory~     pressure (PEEP) is performed with a size of the lung volume increase which corresponds to the~     tidal volume which the patient is ventilated with. The measurements are performed in sedated~     and mechanically ventilated patients in the intensive care unit.~   "
47242|NCT02948517|"~     Time restricted feeding (TRF) is a novel form of intermittent fasting that involves confining~     the period of food intake to 8 h/d (e.g. 10 am to 6 pm) without calorie counting. TRF is~     effective for weight loss and cardio-protection in obese adults. It is of great interest to~     see whether subjects can adhere to TRF for longer periods of time, and to see what degree of~     weight loss that can be achieved with TRF. Accordingly, the aims of this trial are: Aim 1: To~     determine if TRF can be implemented to facilitate weight loss in obese adults, and Aim 2: To~     determine if TRF can produce clinically meaningful reductions in plasma lipids, blood~     pressure, insulin resistance, and inflammatory markers.~   "
47445|NCT02945878|"~     This is a prospective, observational study to analyze the clinical and dosimetric factors~     about the radiation oral mucositis caused by radical chemo-radiotherapy for nasopharyngeal~     carcinoma patients and try to find the indicators for acute radiation oral mucositis.~   "
47243|NCT02948504|"~     Intracranial aneurysms are common in the general population. The overall prevalence of~     unruptured intracranial aneurysms (UIAs) is estimated of 2.3-3.2% in the population without~     specific risk factors for SAH. As noninvasive imaging modalities are more commonly used than~     before, UIAs are increasingly being detected. Most patients with small aneurysms (less than~     5mm) are incidentally found in clinical practice. Some studies indicate that the majority of~     patients with UIAs, particularly with small aneurysms (<7mm), have a low risk of rupture, and~     others have found that small ruptured aneurysms have a high proportion in patients with SAH.~     Therefore, there is a lot of controversy regarding which small aneurysms can be left~     untreated, or which aneurysms are needed to be treated with clipping or coiling.~      The prevalence varies widely among different detection methods, race/ethnicity or patients~     with other inherited diseases. Although a wealth of data is available for the natural history~     of UIAs, the true natural history remains unknown because case selection bias occur in almost~     all studies. However, data on Chinese UIA is unknown. Using the MR angiography (MRA) to~     detect aneurysms, the prevalence is 7% of selected adult population in China. Therefore,~     small UIAs are very common and are increasingly being detected in clinical practice.~     Conservative treatment, surgical clipping and endovascular coiling are the three treatment~     options for UIAs. The optimal treatment remains controversial, particularly for small~     aneurysms (less than 7mm). To date, no clinical trials have compared the safety and efficacy~     between conservative treatment and surgical clipping or endovascular coiling for UIAs. It may~     be impossible to conduct the randomized controlled study considering aneurysm ruptured as a~     devastating event. However, surgical clipping or endovascular treatment itself carries a risk~     of immediate morbidity or mortality. Therefore, a substantial variability widely exists in~     treatment decision-making for UIAs, and this may lead to a great variability in clinical~     recommendations.~      Our study is a prospective observational study to identify the incidence of rupture of small~     aneurysms in the first year after the diagnosis of the aneurysm which is left untreated.~     Meanwhile, we determine the differences of outcomes, procedural complications, and rates of~     retreatment between surgical clipping and endovascular coiling for small UIAs in China.~   "
47244|NCT02948491|"~     Pragmatic, randomized controlled clinical trial with blinding of the evaluator, performed in~     order to estimate the effectiveness, six (6) months after hospital discharge, of music~     therapy on the intra-hospital evolution and neurodevelopment of preterm neonates (gestational~     ages 28 to 37weeks) who are treated in Neonatal Intensive Care Units (NICU) in the~     Bucaramanga Metropolitan Area.~   "
47245|NCT02948478|"~     Precariousness is a multifactorial concept that can be broken down in the form of economic~     insecurity, and / or social insecurity and / or territorial insecurity. Precariousness has an~     impact on health that is difficult to assess precisely because it also impacts on other~     factors that may themselves influence health. Therefore, the understanding of the impact of~     precariousness on health involves studying individuals in their context.~      Our study is designed to assess the impact of precariousness on the history of breast cancer,~     on care pathways, on treatment and rehabilitation in a multidisciplinary contextual analysis.~     Indeed, the socio -economic and geographical inequalities affect the history of breast~     cancer, treatment and its delay and post- treatment rehabilitation.~      The main objective of this project is to compare the stage of disease at diagnosis (according~     to the TNM classification) in deprived and non deprived patients. The secondary objectives~     are to compare in the two groups - the socio-economic and geographical inequalities - the~     direct and indirect costs related to the management, the out-of pocket costs and to describe,~     based on individual inequalities identified, the pathway of care of the patient.~      These objectives will be pursued in the framework of an observational cohort study,~     prospective, multicenter (Ile de France) comparative exposed / unexposed category. Each~     precarious patient will be matched to a non- precarious patient in the same age group,~     regardless of the center. The study will include any patient resident in Ile de France~     seeking treatment for breast cancer, regardless of the stage.~   "
47246|NCT02948465|"~     Cerebral infarcts represent a major cause of morbidity/mortality in spite of therapeutics for~     a premature recanalisation (intravenous recombinant tissue plasminogen activator (rt-PA) and~     thrombectomy). Thrombolysis failure by the administration of rt-PA is frequent, in particular~     in proximal occlusion. Experimental studies suggest that neutrophils could play an important~     role in the thrombus development via the organization of a network (NET) within the thrombus.~     Targeting this network of NET could, in addition to the fibrinolysis, increase the rate of~     recanalisation and thus improve the neurological prognostic after a cerebral infarct.~      The aim of the research is to Study of the biochemical and histological composition of the~     stemming thrombi of cerebral thrombectomies with in vitro analysis of the sensibility in the~     thrombolysis induced by rt-PA +/- Desoxyribonuclease I (DNase I).~   "
47247|NCT02948452|"~     This study is designed to understand responsiveness to reward in adolescents with~     restricting-type anorexia nervosa compared with non-clinical controls, and how it is affected~     by potential-threat perception.~   "
47248|NCT02948439|"~     Maintenance of a healthy pregnancy depends on an appropriate adaptation and responsiveness of~     blood vessels, to ensure appropriate blood flow to the fetus during everyday stressors.~     Previous work by the investigators has demonstrated that during pregnancy, the part of the~     nervous system responsible for cardiovascular function (the sympathetic nervous system) is~     hyperactive. The investigators also know that in women who develop high blood pressure during~     pregnancy that sympathetic nervous system activity is even higher. Yet, very little is known~     about why this occurs and how this might be affected.~      Pregnant women are encouraged to be active, yet, less than 15% of women perform sufficient~     exercise to meet current guidelines. This is important because hyperactivity of the~     sympathetic nervous system is observed in other inactive populations and has been linked to~     adverse cardiovascular health outcomes including hypertension, atherosclerosis, heart attack,~     and stroke. Indeed, in 2011, the American Heart Association stated that inactivity was a risk~     factor as potent as cigarette smoking for the development of future cardiovascular disease in~     women.~      The investigators' work and others have demonstrated that exercise during pregnancy is~     beneficial for both the mom and baby; however, the effect of prenatal exercise on~     neurovascular function is not known. If exercise is effective in controlling the increase in~     sympathetic activity that occurs during pregnancy, or its effects on the cardiovascular~     system, this may help prevent the development of high blood pressure or other cardiovascular~     problems during pregnancy.~   "
47260|NCT02948283|"~     This pilot clinical trial studies the side effects and best dose of metformin hydrochloride~     and ritonavir in treating patients with multiple myeloma or chronic lymphocytic leukemia that~     has returned after a period of improvement or has not responded to treatment. Metformin~     hydrochloride and ritonavir may stop the growth of cancer cells by blocking some of the~     enzymes needed for cell growth.~   "
47274|NCT02948101|"~     The goal of this clinical research study is to learn about the effects of PD 0360324 on~     participant's immune system in participant's with epithelial ovarian, Fallopian tube, or~     primary peritoneal cancer and who have agreed to participate on Protocol PA13-0291. As part~     of this study, participant will also receive a type of standard chemotherapy called~     cyclophosphamide.~      The safety of PD 0360324 and cyclophosphamide will also be studied.~   "
47249|NCT02948426|"~     Ovarian cancer is a leading cause of cancer death in women. Monocytes are white blood cells~     that slow tumor growth. Interferons (IFNs) are molecules that help immune cells fight cancer.~     Researchers want to stimulate monocytes with IFNs. They want to test if these stimulated~     monocytes combined with the drugs Sylatron and Actimmune can shrink tumors and slow the~     progression of cancer.~      Objective:~      To test how well IFN stimulated monocytes, with Sylatron and Actimmune, kill tumor cells.~      Eligibility:~      Women ages 18 and older with certain ovarian, fallopian tube, or peritoneal cancers~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Blood and urine tests~      Scan~      Results or sample from previous biopsy~      Participants may have a tumor sample taken.~      Participants who do not have a port will have a catheter placed inside the abdominal cavity.~     It will be used to give the treatment.~      Participants will have visits for 4 days of each 28-day cycle. This includes overnight~     observation.~      Participants with ascites fluid in their abdominal cavity will have it sampled twice.~      Each cycle, participants will have:~      Blood tests~      Leukapheresis. Some blood is removed and put through a machine that separates out the~     monocytes. The rest of the blood is returned to the body.~      Infusion of the monocytes and study drugs~      Participants will have weekly phone calls in Cycle 1 and scans every 2 cycles.~      Participants will continue treatment until they can no longer tolerate it or their cancer~     gets worse.~      Participants will have a visit about 1 month after stopping treatment, then monthly phone~     calls.~   "
47250|NCT02948413|"~     Background:~      A cancer diagnosis is a threat to life and bodily integrity. This can cause people with~     cancer to experience traumatic stress. Researchers want to better understand the types of~     stress and emotional reactions people with cancer experience. They also want to know if the~     stress people with cancer have had during their life affects their stress related to cancer.~      Objective:~      To see if lifetime traumas, along with psychosocial distress, can predict traumatic stress~     symptoms in people with cancer.~      Eligibility:~      People ages 18 and older who have had or are currently getting care from the NIH Clinical~     Center for one of these cancers:~      Leukemia~      Lymphoma~      Mesothelioma~      Prostate cancer~      Design:~      Participants will be screened with name, date of birth, and diagnosis.~      Participants will allow access to their medical records.~      Participants will complete, online or in person, a demographic sheet and 3 questionnaires:~      The PTSD Checklist for DSM-5: This assesses traumatic stress symptoms and takes 5 10~      minutes to complete.~      The Life Events Checklist for DSM-5: This assesses potentially traumatic life events and~      takes about 5 minutes to complete.~      The Brief Symptoms Inventory 18: This assesses psychosocial distress and takes about 4~      minutes to complete....~   "
47251|NCT02948400|"~     The investigators will conduct a non-inferiority clinical trial to evaluate whether children~     trained in pedestrian safety amidst a Google Cardboard virtual environment achieve equivalent~     levels of pedestrian safety to children trained in a full semi-immersive virtual pedestrian~     environment~   "
47252|NCT02948387|"~     Determine if antibiotic prophylaxis with intravenous cephalosporin and aminoglycoside in~     patients with Type II and II open fractures is safe and effective.~   "
47253|NCT02948374|"~     Critical care patients are at a high risk of developing delirium and impaired cognitive~     function 3 and 12 months after their ICU stay. In this study the aim is to try to elucidate~     the pathophysiology behind delirium in the ICU and subsequent development of cognitive~     dysfunction in ICU survivors.~      Biomarkers in cerebrospinal fluid (CSF) will be analysed in patients with and without~     delirium in the ICU. Samples will also be taken 3 and 12 months after the ICU-stay. CSF will~     also be obtained in healthy age- and sexmatched controls undergoing surgery.~   "
47254|NCT02948361|"~     Subjects will be scanned on the QT Ultrasound Breast Scanner. For subjects that may have~     breast calcifications and/or mass(es) and/or other finding(s) on the QT scan image(s),~     standard imaging modalities (e.g., mammogram and HHUS) will be performed per ACR~     recommendations.~      If available, subjects may provide copies of their breast imaging exams and related reports.~      Demographics and medical history will be collected.~   "
47255|NCT02948348|"~     This is a phase Ib/II, open-label, single-arm, multicenter study to investigate the safety,~     efficacy, and proof of concept (POC) of monotherapy with nivolumab, an anti-PD-1 antibody~     drug, as a sequential therapy following chemoradiotherapy (CRT) with capecitabine and~     subsequent surgical therapy in patients with locally advanced resectable rectal cancer.~   "
47256|NCT02948335|"~     Microorganisms that colonize hospital environments play an important role in the transmission~     of hospital acquired infections (HAI) and multi-drug resistant organisms. Previous studies~     examining microorganisms in the hospital environment have been limited by reliance on~     targeted culture-based methods resulting in potentially missed or unrecognized organisms.~     Evidence now suggests that using microbiome analysis offers an innovative strategy that may~     improve our understanding of HAI and how best to prevent them.~      This pilot longitudinal observational study aims to characterize the taxonomic composition of~     microbial communities on environmental surfaces and people in these environments prior to and~     following the introduction of patients, caregiver, and hospital staff to newly constructed~     inpatient care areas at St. Jude Children's Research Hospital (SJCRH). This proposed study is~     uniquely characterized by evaluating the hospital environment of a pediatric~     immunocompromised oncology patient population that has not been studied in the past using~     advanced molecular techniques such as microbiome analysis.~      PRIMARY OBJECTIVE:~        -  To describe the pattern of microbial communities of the hospital environment before,~          during and after patient occupancy of a newly constructed hospital space.~      SECONDARY OBJECTIVES:~        -  To describe the similarity or difference of environment microbial communities to that of~          the humans occupying this environment in a newly occupied hospital space.~        -  To describe the pattern in environment microbial communities after each step of~          disinfection (manual cleaning with chemical disinfectant and Ultraviolet light~          disinfection machine) after patient discharge from the inpatient hospital environment.~        -  To evaluate the correlation between environmental Adenosine Triphosphate (ATP) measures~          and organism bioburden.~   "
47257|NCT02948322|"~     In this study, the investigators will evaluate the cardiac structure and function, focusing~     on the myocardial water content and interstitial fibrosis, in patients with active acromegaly~     in comparison with 1) healthy volunteers, 2) the same acromegalic patients that have received~     efficient therapy.~      The investigators hypothesize that the myocardial water content in acromegaly is increased as~     these patients present with sodium and water retention and that this myocardial water~     infiltration will improve with efficient treatment of the disease. They will thus assess~     using CMRI, this parameter by measuring the myocardial transverse relaxation time (T2),~     reflecting water content in the myocardium.~   "
47324|NCT02947451|"~     Patients with knee Osteoarthritis have high prevalence of pain , requiring ever more precise~     interventions in their management. This study aims to investigate the immediate effects of~     manual therapy and TENS on pain in patients with knee Osteoarthritis. Knowledge of best~     interventions favors reducing spending on health and safety for the patient.~   "
47261|NCT02948270|"~     The interpersonal problems of adolescents with ADHD may be the most debilitating aspect of~     their psychopathologic behaviour. This being said, the investigators still do not have a~     clear understanding of why it is the case that individuals with ADHD have such impaired~     social and communicative competence. In particular, research has not identified whether the~     communicative difficulties stems from deficits in taking the perspective of a communicative~     partner, or in being able to make use of this information in a systematic way. This study~     will compare adolescents with ADHD to adolescents not diagnosed with ADHD and their~     performance on a number of social inference and communication tests. This study hypothesizes~     that persons with ADHD will not perform as effectively as control participants on the social~     inference and communication tests, and will evidence lower WM score. As well, this study~     hypothesizes that a working memory/cognitive load task will impede performance on certain~     social inference and communication tests to a greater extent in the ADHD population than in~     the control group.~   "
47262|NCT02948257|"~     The objective of the registry is to collect procedural outcomes data when the Cardiva VASCADE~     Vascular Closure System (VCS) is used to seal femoral arterial access sites at the completion~     of ipsilateral peripheral interventional procedures performed through 5-7F introducer sheaths~     via an antegrade approach.~   "
47263|NCT02948244|"~     This multi-centre, randomised, double-blind, placebo-controlled crossover trial will compare~     changes in strength-related motor function following treatment with creatine monohydrate to~     treatment with placebo, as measured by the Motor Function Measure, from baseline to 12 weeks.~     Eligible subjects will undergo baseline assessments then will be randomised to either~     creatine monohydrate therapy or placebo for three months, followed by a six week wash-out~     period, then crossover to a further three months of therapy with either placebo or creatine.~     Subjects will undergo clinical assessments and study safety assessments at the beginning and~     end of each treatment period. The study will begin recruitment in early 2017.~   "
47264|NCT02948231|"~     The Mistral is an investigational device intended for percutaneous trans-catheter repair in~     high risk for surgery individuals suffering from functional Mitral Regurgitation.~      The device system is to be used only in accordance with the approved Investigational Plan on~     subjects who have signed an informed consent form. Device use is limited to the approved~     study investigators.~   "
47265|NCT02948218|"~     Knee osteoarthritis (KOA) is a major public health problem among the elderly and is~     associated with considerable disability. A recent analysis of data indicated that about 35%~     of women and men aged 60 years and above had radiographic knee OA.Despite the high prevalence~     rate of OA, the treatment of OA is far from satisfactory. Acupuncture may be a promising~     treatment option for knee OA due to the effectiveness of the pain relief and the rarity of~     adverse effects. In order to get some more reliable data to confirm acupuncture effectiveness~     on KOA, a long-term follow up interventional study will be started to confirm the effects of~     long term for acupuncture treatment.~   "
47266|NCT02948205|"~     This study intends to carry out a prospective, randomized controlled trial to compare the~     trans-umbilical laparoendoscopic single-site surgery by 3D laparoscopy with normal~     laparoendoscopic surgery in the treatment of infertility patient, so as to further clarify~     the safety and curative effect of TU-LESS by 3D laparoscopy and provide evidence-based basis~     for its application in infertility population.~   "
47267|NCT02948192|"~     Pregnant African American women between 18 and 45 years of age will be enrolled at 20 weeks~     of gestation or less. Biological specimens (vaginal swabs, rectal swab) will be collected at~     enrollment, 23-24 weeks, at 28-29 weeks, and at the onset of labor. A urine sample will be~     obtained at entry and at the time of delivery for metabolomic analysis. Participants will~     also collect a dietary survey at entry, 23-24 weeks, and 28-29 weeks. The biological~     specimens will then be analyzed for their microbiomial profile. This will then be correlated~     with the timing of their delivery as well as other comorbidities such as obesity,~     hypertension, and diabetes.~   "
47268|NCT02948179|"~     Autosomal dominant polycystic kidney disease (ADPKD) is the most common monogenic hereditary~     kidney disease in humans. ADPKD may affect all the generations of the ADPKD family and the~     probability of ADPKD is 50% in the second generation for each gender. It has been confirmed~     that PKD1 and PKD2 are two pathogenic genes of ADPKD. Nowadays, the investigators have~     established an effective gene detection technology platform for PKD1/2 gene with long~     fragment PCR and next generation sequencing. First, the investigators performed genetic~     testing in patients with clinically diagnosed ADPKD and strong fertility desire, but afraid~     of hereditary risk. Using Preimplantation genetic diagnosis, including multiple annealing and~     looping-based amplification cycles amplification technique, the investigators successfully~     screened out healthy embryos by In Vitro Fertilization. Then the investigators transplanted~     embryos returned to the parent. When the baby is born, using umbilical cord blood gene~     detection, the investigators confirmed that the neonates do not inherit genetic defects form~     parents. The investigators have succeeded in one couple. The investigators design a~     multicenter clinical trial to confirm those procedures efficacy and safety.~   "
47269|NCT02948166|"~     Comparison of two methods for revascularization of the superficial femoral artery: remote~     endarterectomy vs. stenting of the superficial femoral artery cin patients with~     steno-occlusive lesion of the femoro-popliteal segment of TASC C, D~   "
47270|NCT02948153|"~     This study raises two main hypotheses: 1) Asthmatics patients who present with bronchial~     hypersecretion differ phenotypically from asthmatic patients without hypersecretion and 2)~     mucins in asthmatic patients with hypersecretion of bronchial mucus and the expression of~     TLRs differ from non-mucus hypersecretory asthmatics patients.~   "
47271|NCT02948140|"~     The aim of the study is to estimate the contribution of abdominal imaging by magnetic~     resonance Imaging (MRI) and abdominal scanner in the detection of subdiaphragmatic infarction~     associated to the atrial fibrillation in the cerebral infarction.~   "
47272|NCT02948127|"~     The purpose of this study is to evaluate the safety, infectivity, and immunogenicity of a~     single dose of a recombinant live-attenuated respiratory syncytial virus (RSV) vaccine in~     RSV-seronegative infants and children 6 to 24 months of age.~      This study is a companion study to IMPAACT 2012.~   "
47273|NCT02948114|"~     The study is intended to evaluate the microorganisms found in infant stools when consuming~     study formulas containing prebiotics and/or probiotics compared to infants consuming mother's~     own breast milk.~   "
47275|NCT02948088|"~     TGCT is a rare disease that is difficult to manage, surgical resection is the primary~     treatment currently available. To date no disease registry exists and there is little data~     available detailing the management of patients with diffuse TGCT, the burden of diffuse TGCT~     for patients (including pain, joint stiffness, swelling, reduced mobility and quality of~     life) or the economic impact of diffuse TGCT.~      This study aims to collect data by an observational disease registry involving no~     intervention to the patient or changes to investigators treatment decisions.~   "
47276|NCT02948075|"~     This is a multicenter, open-label study of safety and efficacy of Quisinostat in combination~     with Paclitaxel + Carboplatin chemotherapy in patients with metastatic or locally advanced~     epithelial ovarian cancer, primarily peritoneal or fallopian tube carcinoma, resistant to~     first line platinum and Paclitaxel based chemotherapy.~      The study will be carried out in 5-8 Russian and Belarusian sites. A maximum of 32 patients~     with metastatic or locally advanced epithelial ovarian cancer, primarily peritoneal or~     fallopian tube carcinoma, resistant to first line platinum and Paclitaxel based chemotherapy,~     will be enrolled in the study.~   "
47277|NCT02948062|"~     The goal of this single institution study is to evaluate boys with adrenoleukodystrophy (ALD)~     diagnosed early in life, and to prospectively monitor them to determine parameters that will~     facilitate earlier detection of the childhood cerebral form of the disease. These at-risk~     subjects will be assessed yearly through travel to the University of Minnesota, where plasma~     and cerebral spinal fluid (CSF) biomarker studies, MRI based imaging and neuropsychological~     assessments will be performed at the University of Minnesota Masonic Children's Hospital and~     Clinics. The MRI and lumbar puncture to obtain CSF will be obtained under sedation. In~     addition, at intervening 6 months intervals information will be obtained remotely, including~     surveys and MRI's in their home location. Also at that time blood samples will be obtained~     locally and shipped to the University of Minnesota for study. There is no therapeutic intent~     in this study.~   "
47278|NCT02948049|"~     This study is a single site, prospective, observational trial utilizing a wrist-worn~     accelerometer to evaluate clinical outcomes of SCS and PNS in the treatment of chronic pain.~   "
47279|NCT02948036|"~     Specific Aim 1: Finalize development of the closed-loop strategy in the Moodify application.~      Specific Aim 2: Evaluate the acceptability and feasibility of the Moodify application with~     the target population to prepare for a large-scale efficacy trial.~   "
47280|NCT02948023|"~     This is a investigative initiated, comparative pilot clinical trial to ascertain the safety~     of application of ex-vivo cultivated limbal stem cells in human eyes for treating different~     superficial corneal pathologies. Pre-clinical work in murine models have already demonstrated~     efficacy of this technique in curing murine corneal pathologies.~   "
47281|NCT02948010|"~     The purpose of this trial is to assess device performance against participants in an~     overnight study to ensure the product meets user and clinical requirements~   "
47282|NCT02947997|"~     The purpose of this study is to test the safety and feasibility of a redesigned tethered~     capsule catheter that contains an integrated micro-motor. Investigators will be testing~     imaging of this new technology in healthy volunteers.~   "
47283|NCT02947984|"~     The purpose of this study is to determine the best radiation dose for participants with~     meningioma that has grown back after previous surgery, or which the surgeon has been unable~     to remove completely. This research study is designed to determine whether a higher dose of~     radiation will decrease the likelihood that the tumor will grow back, compared to the~     probability of re-growth that occurs after standard radiation doses.~   "
47284|NCT02947971|"~     The goal of this research is to test a distal scanning capsule and a compact redesigned~     version of the OFDI imaging system in healthy and BE subjects to assess ease of use, safety~     and feasibility in preparation for its use in a multicenter clinical trial.~   "
47285|NCT02947958|"~     To evaluate the effectiveness of the use of teleconsultation in qualifying counter-reference~     between tertiary and primary care for patients with stable benign prostatic hyperplasia (BPH)~     symptoms.~   "
47286|NCT02947945|"~     Reslizumab is a type of medicine called a monoclonal antibody that is made in the research~     clinic; it works by blocking a specific protein in the body called interleukin-5. The study~     medicine, reslizumab, is not yet approved for doctors to treat patients with EGPA. It is~     considered an experimental drug in this study.~   "
47287|NCT02947932|"~     Acute pancreatitis is the most common and feared complication of ERCP, occurring after 1% to~     30% of procedures. Since 2012, a multicenter RCT was published in NEJM, indomethacin use in~     high risk patients was considered a standard method to prevent PEP. However, the risk~     factors of PEP is not fully clear. Additionally, the complication of NSAID use lead to some~     serious physical problem bleeding. Therefore, the exclusive criteria for limiting the NSAID~     use is including allergy， gastrointestinal haemorrhage ，presence of coagulopathy or received~     anticoagulation therapy. Previous study showed that another natural compound, resveratrol,~     owns similar biological effect with NSAID. Firstly, it could inhibit the inflammatory~     response on in vivo model through inhibition of COX and IL-6 etc. Secondly, it could not~     influence the level of platelet and coagulation, which means safer than NSAID. Thirdly,~     numerous studies showed that resveratrol could effectively the progression of severe acute~     pancreatitis. According to data, we design the project. The purpose of this study is to~     determine whether oral resveratrol pre-ERCP is effective on control of Post-ERCP~     pancreatitis.~   "
47288|NCT02947919|"~     Preoperative anxiety and stress are present in up to 60% of pediatric patients undergoing~     surgery, having a great physiological and emotional impact on children in both the short and~     long term. There are many reports on the use of music therapy in the perioperative period as~     a complementary technique in the preoperative stress and anxiety management. However, there~     are no assessments of the effect of this intervention on the physiological variables, such as~     salivary cortisol.~   "
47289|NCT02947906|"~     Fifty patients who were referred to receive physiotherapy and 20 healthy volunteers will be~     participants of the study.Participants with multiple sclerosis will evaluate with the~     following assessment tools: Modified Ashworth scale will use to evaluation of severity of~     plantar flexor spasticity. Plantar pressure distribution parameters will assess with dynamic~     pedobarography.~   "
47290|NCT02947893|"~     The investigators hypothesize that Nilotinib will be safe in individuals with mild to~     moderate AD. Specifically, investigators hypothesize that low daily oral doses of Nilotinib~     will lead to CSF penetration, CNS Abl inhibition, and stabilization of CSF total Tau and~     p-Tau231/181 and Abeta42/40 levels. The investigators hypothesize that Nilotinib will~     decrease brain load of amyloid using amyloid positron emission tomography (PET). The~     investigators also predict that Nilotinib will reduce CSF markers of cell death, including~     neuron specific enolase (NSE) and S100B.~   "
47291|NCT02947880|"~     During a previous therapeutic trial, investigators showed that the bumetanide improved~     significantly autism. This trial showed that a therapeutic response was obtained in 75% of~     cases.~      These first results were reinforced by a study led with adult patients for whom the eye~     tracking measurements as well as the functional MRI showed a diminution of the response time~     and a modification (amplification) of the cerebral response during an emotions recognition~     test.~      Finally, investigators confirmed the physiological mechanism behind the action of the~     bumetanide in a study in two mouse models of autism.~   "
47292|NCT02947867|"~     A prospective, randomised, placebo-controlled, double-masked, three-armed multi-centre phase~     II/III trial for the Study of a Topical Treatment of Ischaemic Central Retinal Vein Occlusion~     to Prevent Neovascular Glaucoma - the STRONG Study~   "
47293|NCT02947854|"~     Fimaporfin (TPCS2a) is a photosensitiser drug being developed by PCI Biotech AS for use in~     novel Photochemical Internalisation (PCI) technology. PCI technology is designed to enhance~     the effects of other drugs in a site-specific, light-directed manner and is used to~     re-localise endocytosed molecules from endosomes to cytosol. This research study is~     evaluating the use of the PCI Technology in combination with adjuvant and vaccine antigens~     for safety and induction of immune responses.~   "
47294|NCT02947841|"~     The purpose of this study is to investigate the hypothesis that alternating DBS parameters on~     a weekly basis will prevent tolerance to stimulation and thus waning of benefit, compared~     with non-alternating stimulation. The primary endpoint will be preserved tremor control with~     the alternating group compared with standard treatment using the Tremor Research Group~     Essential Tremor Rating Assessment Scale (TETRAS). Key secondary endpoints will be preserved~     activities of daily living measures as well as preserved tremor control as quantified by~     motion sensor data.~      This study has one primary aim: To determine if alternating DBS stimulation parameters on a~     weekly basis will be superior at preserving tremor control compared with usual stimulation~     (non-alternating stimulation) in ET patients with VIM DBS.~   "
47295|NCT02947828|"~     This is a population-based study of type 2 diabetes patients with and without neuropathy~     recruited from the Danish National Type 2 Diabetes cohort (DD2).~      Perspective: The study will identify risk factors for developing diabetic polyneuropathy and~     painful diabetic polyneuropathy and provide information on the underlying mechanisms, which~     will hopefully contribute to significant improvements in the treatment and prevention of~     diabetic polyneuropathy in future.~   "
47296|NCT02947815|"~     The purpose of this study is to evaluate the Efficacy and Safety of NABOTA in treatment of~     essential blepharospasm~   "
47297|NCT02947802|"~     This is an online survey assessing consumer support for different labeling policies related~     to sugar sweetened beverages. The investigators will present consumers with three labels that~     are being considered for sugar sweetened beverages: a calorie label, a text warning label~     that says Warning drinking beverages with added sugar(s) can lead to health problems like~     obesity, diabetes and tooth decay and a graphic warning label that includes graphic images~     to correspond with each of the health problems listed with the text warning. The~     investigators will ask participants their support for each label. The investigators will also~     see if support for the labels change after learning of the effectiveness of these labels. The~     investigators will share the results of a recent field study that suggested calorie and~     textual warning labels had no influence on the purchasing of sugar sweetened beverages while~     the graphic label decreased purchasing by 11 percent.~   "
47298|NCT02947789|"~     Surgery has risk of morbidity and mortality. Risk factors include: patient factors; surgical~     factors; and anesthetic factors. The risk is much higher in emergency cases. The study of~     relevant risk factors can lead to improvement in patient management and reduction in~     mortality.~   "
47299|NCT02947776|"~     Aims: This exploratory trial will:~        1. Explore the feasibility of a definitive/phase III RCT on clinical and cost-effectiveness~          of peer-befriending for people with aphasia post-stroke.~        2. Investigate psychological and social wellbeing outcomes of participants, significant~          others, and peer befrienders.~        3. Explore the feasibility of a full economic evaluation of usual care + peer befriending~          versus usual care control.~      Design: Single blind, mixed methods, parallel group phase II RCT comparing usual care +~     peer-befriending vs. usual care, starting at discharge from hospital. The study will deliver~     on four work packages: development phase; RCT; qualitative study; economic evaluation.~     Participants (n=60) will be assessed three times up to 10 months post-randomisation.~      Outcome measures: Feasibility: feasibility of recruitment to definitive trial (proportion~     screened who meet criteria; proportion who consent; rate of consent); participant,~     significant other, peer befriender views on acceptability of procedures (qualitative study);~     number of missing/incomplete data on outcome measures; attrition rate at follow-up; potential~     value of conducting main trial using value of information analysis (economic evaluation);~     description of usual care; treatment fidelity of peer-befriending. Patient-reported outcomes~     will include mood, wellbeing, communication and social participation.~      Benefits: Peer befriending may help avert some of the serious psychological consequences of~     stroke, and prevent the need for more complex and costly psychological therapies.~   "
47300|NCT02947763|"~     Healing rate after single visit or multiple visit endodontic treatment using triple paste~     intracanal medicament will be assessed both clinically and radio-graphically for follow-up~     period up to one year~   "
47301|NCT02947750|"~     The purpose of this study is to find out why patients with chronic kidney disease (CKD) have~     poor exercise capacity and to explore what causes an increase in blood pressure during~     exercise (i.e. increased adrenaline levels, or decreased ability of blood vessels to dilate).~     This study will also test whether or not regular exercise on a bicycle and/or treatment with~     6R-BH4 (Kuvan) pills improves these measures during exercise. 6R-BH4 is currently~     FDA-approved for use in patients with certain forms of a disease called phenylketonuria, but~     it is not currently FDA approved for blood pressure or exercise capacity in people with CKD.~   "
47302|NCT02947737|"~     The purpose of this study is to compare the effectiveness of applying amniotic membrane~     dressings compared to gentamicin and xeroform dressings to donor sites for skin grafts. This~     study will enroll ten participants who undergoing a split thickness skin graft procedure with~     two or more donor sites. The amniotic membrane will be applied to one donor site and a~     dressing of xeroform and gentamicin will be applied to another other donor site. Each~     participant will receive both types of dressing and will serve as their own control.~     Postoperative follow up will follow standard of care, regardless of the dressing type.~     Dressings will be removed on postoperative day 4 and participants will return to be~     re-examined one week after being discharged from the hospital.~   "
47303|NCT02947724|"~     Two hundred women aged from 20 to 35 years undergoing conservative laparoscopic treatment of~     ovarian endometriomas (either by drainage or cyst wall excision) were included. Participants~     were randomized into 4 groups; group A (drainage only) in which 50 patients underwent~     laparoscopic fenestration and electrocautery of the endometrioma cyst wall, group B~     (cystectomy only) in which 50 patients underwent laparoscopic excision of the endometrioma~     cyst wall, group C (drainage & Surgicel) in which 50 patients underwent laparoscopic~     fenestration of the endometrioma cyst wall followed by insertion of 4 pieces of Surgicel~     inside the cyst cavity, group D (cystectomy & Surgicel) in which 50 patients underwent~     laparoscopic excision of the endometrioma cyst wall followed by insertion of 4 pieces of~     Surgicel inside the remaining ovarian tissues.All patients were followed up every 3 months~     for 2 years following the laparoscopic surgery. The primary outcome was the recurrence of~     endometriomas in the ipsilateral ovary (recurrence was defined as the presence of ovarian~     cysts with the characteristic sonographic features of endometriomas (≥1 cm). The ovarian~     reserve was reassessed (AMH & day 2 AFC) as a secondary outcome 6 months following the~     laparoscopy.~   "
47304|NCT02947711|"~     This Phase 1, open-label, single-sequence, drug-drug Interaction study is conducted to~     evaluate the effect of diltiazem extended release (ER) (a moderate CYP3A inhibitor and P~     glycoprotein [Pgp] inhibitor) on the pharmacokinetics (PK) of a single oral dose of E2027 in~     healthy participants.~   "
47305|NCT02947698|"~     Increased in-hospital mortality associated with weekend admission has been reported for many~     acute conditions, but no study has investigated weekend effect for acute kidney injury~     requiring dialysis (AKI-D). In this study, the investigators compared mortality in AKI-D~     patients admitted on weekday versus weekend and assessed factors associated with increased~     mortality.~   "
47306|NCT02947685|"~     The primary objective of this study is to demonstrate that the combination of palbociclib~     with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus~     endocrine therapy alone in improving the outcomes of subjects with hormone receptor-positive,~     HER2+ metastatic breast cancer.~   "
47307|NCT02947672|"~     Effect of intravenous versus intra-peritoneal dexamethasone on the incidence of postoperative~     nausea and vomiting following Laparoscopic gynecological surgeries.~   "
47308|NCT02947659|"~     [Purpose] To investigate the prevalence of musculoskeletal disorders among healthy students~     of Ahlia University and to determine the relationship between the prevalence of~     musculoskeletal disorders and academic stressors and body mass index. [Subjects and Methods]:~     Self-administered questionnaires were distributed to 94 students aged 18-26 years who were~     enrolled at various Ahlia University colleges and met other inclusion criteria. The students~     responded to the standardized Nordic musculoskeletal questionnaire and the modified College~     Student Stress Inventory regarding musculoskeletal symptoms and academic stressors. Height~     and weight measurements were also obtained to determine body mass index.~      Keywords: Body mass index, Academic stress, Musculoskeletal disorders~   "
47309|NCT02947646|"~     This is a pilot, randomized, safety and efficacy study of an investigational device (i.e.~     BabyGentleStick™; BGS, Actuated Medical, Inc). The primary study objectives are to obtain~     subject feedback, assess device performance; and ascertain potential harm in healthy adult~     volunteers.~   "
47310|NCT02947633|"~     The purpose of this research is to compare the effect of single-injection sciatic PNB to~     continuous sciatic PNB on 1) postoperative pain control as measured by self-reported pain~     scores, pain medication use, and unplanned hospital admission due to poor pain control, 2)~     active knee flexion, and 3) patient satisfaction with pain control following ACL~     reconstruction with a hamstring autograft. The results of this research have the potential to~     positively impact pain control for the adolescent population undergoing this surgical~     procedure and foster responsible utilization of limited resources.~   "
47311|NCT02947620|"~     A Multi-center, Randomized, double-blind, active-controlled, phase 3 trial to evaluate the~     safety and efficacy of Metformin/Atorvastatin in subjects with Type II Diabetes and~     dyslipidemia.~   "
47312|NCT02947607|"~     The purpose of this study is the investigation of new host-microbiome interactions promoting~     adenoma formation and adenocarcinoma progression. For that purpose, the investigators will~     collect saliva, stool and colon biopsy specimens from patients referred to colonoscopy or~     surgical resection of colorectal tumor. Besides, a questionnaire about diet, lifestyle and~     medical history will be collected. Sample analysis will involve simultaneous characterization~     of host and microbiota genomic and transcriptomic components.~   "
47313|NCT02947594|"~     Parenteral nutrition-associated cholestasis (PNAC) is one of the most common complications~     resulting from administration of parenteral nutrition in neonates. Excess intravenous intake~     of vegetable oil-based lipid emulsions containing phytosterols is felt to be a major~     contributing factor. To date, no information is available on plasma phytosterols half-lives~     in very-low-birth-weight (VLBW) preterm infants with PNAC. In a prospective cohort study,~     plasma phytosterols (campesterol, stigmasterol and sitosterol) of VLBW preterm infants with~     PNAC will be measured by gas chromatography-mass spectrometry (GC-MS) during PN~     administration and also after the stop of intravenous lipid infusion. Plasma phytosterols~     half-lives will be calculated from the monoexponential decay curves. Blood samples will be~     weekly collected from 1st to 12th week of life during routine metabolic tolerance analysis or~     gas-analysis in order to avoid burden of additional phlebotomy. Samples will be collected in~     ethylenediaminetetraacetic acid-tubes and immediately centrifugated. Plasma will be stored in~     pyrogallol added-tubes at -20°C until analysis. Saponification reaction will be done using~     5-alpha-cholestane as internal standard.~   "
47314|NCT02947581|"~     Taenia solium neurocysticercosis (NCC) is a parasitic infection causing much neurological~     disease in most of the world. When parasites locate in the cavities around the brain~     (subarachnoid NCC, SANCC), it becomes an aggressive, progressive and frequently lethal~     presentation. Current treatment regimens for SANCC have quite limited efficacy. The~     investigators propose to compare the current standard of care (a single antiparasitic drug,~     albendazole) with a combined regimen using two antiparasitic drugs simultaneously by adding~     praziquantel. The trial will enrol 164 patients in four centers, two in Peru, one in Ecuador,~     and one in Brasil.~   "
47315|NCT02947568|"~     The present study investigates relationship between non-alcoholic fatty liver disease and its~     risk factors, such as genetic background and diseases, such as chronic kidney disease and~     diabetes mellitus.~   "
47316|NCT02947555|"~     The rate of lens autofluorescence will be compared in diabetic and non diabetic patients~     with/without atherosclerotic vascular diseases to evaluate if it is associated with the risk~     of cardiovascular diseases.~   "
47317|NCT02947542|"~     There is no evidence from prospective randomized clinical trials regarding the performance of~     conventional (two-catheter-concept; TCC) versus one-catheter-concepts (OCC) for invasive~     coronary angiography over the radial access.~      The aim of the present trial is to evaluate the efficacy and safety of different one-catheter~     concepts by use of the BLK and Tiger catheter compared to a TCC using standard Judkins~     catheters in diagnostic coronary angiography via transradial access. Patients with stable~     angina pectoris will be randomly assigned to coronary angiography performed with the BLK or~     Tiger (OCC) or Judkins catheters (TCC). The primary endpoint is coronary angiography~     duration.~   "
47318|NCT02947529|"~     BACKGROUND: Tranexamic acid (TXA) has been used widely for the reduction of post operative~     blood loss for various orthopaedic procedures including but not limited to total hip~     arthroplasty and total knee arthroplasty. A recent multihospital meta-analysis conducted in~     2013 showed that patients who received TXA showed a significant reduction in post-operative~     transfusion (20.1% to 7.7%). The procedures the investigators will be evaluating are the~     intramedullary nail for intertrochanteric fracture and hip hemiarthroplasty. These procedures~     are similar to the total hip or knee replacement in that they can result in significant blood~     loss that requires a post operative transfusion.~      STUDY PURPOSE: To determine the efficacy of TXA to decrease the rate of post-operative~     transfusion for acute hip fractures repaired with the following two methods, intramedullary~     nailing for intertrochanteric fracture and hemiarthroplasty.~      METHODS: The model for the study is a prospective randomized control trial. Patients will be~     placed in one of two arms of the study after passing our inclusion criteria. The arms will be~     for either the intramedullary nailing for intertrochanteric fracture or for hemiarthroplasty.~     These two categories will be subdivided into those receiving TXA and those not receiving TXA.~     The patients in each category will have standard post-operative care and laboratory testing.~     The investigators will record the patients in either arm of the study, whether it be no TXA~     or TXA, who require post-operative transfusion within 1 week of the operation.~   "
47319|NCT02947516|"~     There are several ways to perform liver biopsies, including the percutaneous route~     (historical gold standard) and via endoscopic ultrasound (EUS) guidance. The primary aim of~     this study is to prospectively compare patients undergoing EUS-guided liver biopsies to~     patients undergoing percutaneous biopsy. The investigators hypothesize that (1) patients who~     are randomized to undergo EUS-guided liver biopsy will rate themselves as having less pain in~     the 48 hours following the procedure, and (2) will have comparable histologic yield to a 2:1~     matched cohort of patients undergoing percutaneous liver biopsies.~   "
47320|NCT02947503|"~     One approach to prevent the rising burden of diabetes is to address the issue of gestational~     diabetes mellitus (GDM). GDM has a growing prevalence up to 5-10% (and even higher in~     specific subgroups), with a pregnant population becoming older and more obese worldwide. GDM~     increases the risks of complications during pregnancy, at delivery and on the longer term,~     like type 2 diabetes (T2D) and persistent obesity, in mother and child. Moreover, insulin~     added to diet as the standard care for GDM has disadvantages for mother (maintenance of~     hyperinsulinaemia, increasing weight and blood pressure) and child (macrosomia,~     hypoglycaemia) with related adverse pregnancy outcomes. Metformin, as an insulin sensitizer~     targeting the cause of GDM, may have essential benefits, as suggested by observational~     studies. However, RCTs with metformin (early positioned in the treatment of GDM) are still~     lacking. The POEM study is the first Randomized controlled trial (RCT) in GDM to test the~     hypothesis that metformin, early given from the start of the diagnosis GDM, on top of diet~     and lifestyle improves clinically relevant pregnancy outcomes in mother and child during~     pregnancy, at delivery and on the longer term - up to 20 years after birth.~   "
47321|NCT02947490|"~     This blinded end point RCT will recruit high risk TIA and mild stroke patients (through the~     emergency TIA clinics and the acute stroke services at the Norfolk & Norwich University~     Hospital) who require anti-hypertensive therapy to examine the clinical and cost~     effectiveness of self-monitoring and self management of Blood Pressure compared to self~     monitoring alone and treatment as usual.~   "
47322|NCT02947477|"~     The proposed study will develop and pilot a fourteen-day assessment tailored for the~     high-demand schedule of residents through a smart phone intervention, EmoTrak.EmoTrak uses~     ecological measurement assessment (EMA), which solicits real-time user feedback at various~     time points across a series of days or weeks.~   "
47323|NCT02947464|"~     Cure rate os pediatric Obstructive Sleep Apnea Syndrome (OSAS) after gold-standard-treatment~     adenotonsillectomy is 50-80 %. Treatment alternatives are scarce, poorly effective and based~     up on low scientific evidence. This means one out of five patients will remain exposed to the~     well-known neurocognitive, behavioral and quality of live adverse effects of disease.~      Rapid Maxillary Expansion, an orthopaedic-orthodontic treatment of pediatric malocclusion,~     has recently shown promising results in the treatment of pediatric OSAS based upon its effect~     on craniofacial and upper airway growth, usually limited in this patients.~      The investigators propose a randomized, prospective, controlled trial in patients with~     Pediatric OSAS non-responding to adenotonsillectomy. The aim of the study is to enhance the~     treatment success rate avoiding morbimortality associated to disease persistence during~     childhood and development during adult life.~   "
47325|NCT02947438|"~     This study is aimed to comprehensively establish the bio-similarity/bioequivalence in EPIAO®~     and EPREX® in terms of 52-week comparisons in efficacy, safety and immunogenicity. The~     targeted population is anaemia patients with end-stage chronic renal disease who previously~     received epoetin treatment and on haemodialysis.~   "
47326|NCT02947425|"~     This is a prospectively registered database of patients with early breast cancer who will be~     treated with radiotherapy during surgery. More than 2000 women have already received this~     treatment in clinical trials. This study will monitor the health status of women who receive~     this treatment outside of a clinical trial, especially those who might not have been eligible~     for the original clinical trials. The aim is to confirm the long-term effectiveness and~     safety of the technique.~   "
47327|NCT02947412|"~     Today sleeve gastrectomy is the most performed bariatric procedure worldwide. Since 2005 it~     is gaining popularity as a single procedure. Long term data is scarce. In this retrospective~     study long term follow-up in relation to weight loss, comorbidities, re-do and revisional~     surgery is getting analyzed.~   "
47328|NCT02947399|"~     This research study is to compare the radiopharmacokinetics of I-124 to the~     radiopharmacokinetics of I-131 in patients who have well-differentiated thyroid cancer after~     thyroid hormone withdrawal. I-131 is routinely used for imaging and dosimetry for patients~     with well-differentiated thyroid cancer. In this study, I-124 is administered orally in~     capsular form, and the radiopharmacokinetics of I-124 is compared with I-131. I-124 is~     another isotope of iodine, which is cyclotron-produced. I-124 has multiple advantages:~        -  Ideal Half-Life (4.2 days) for delayed imaging.~        -  High resolution tomographic imaging.~        -  Feasibility of quantitating lesion uptake.~        -  Potential of dosimetry for the planning of radioiodine therapy.~      Voluntary patients will have I-124 dosimetry performed in addition to the I-131 dosimetry,~     which is planned as part of routine clinical care. I-124 dosimetry is composed of three~     parts: (1) the administration of I-124, (2) imaging, and (3) drawing blood samples.~      Patients will start 3-5 weeks of thyroid hormone withdrawal. This is similar to the procedure~     for I-131 dosimetry. Second, they will receive I-124. I-124 is similar to I-131 except I-124~     decays in a different way to emit a positron so that the PET scanner can be used for imaging.~     I-124 is given in the form of one or several capsules, which are taken by mouth. This is also~     similar to I-131. Third, PET/CT imaging is done for approximately 30 minutes to one hour on~     five consecutive days. Radiation from PET/CT scan is far less than what they receive from a~     diagnostic CT scan. For the fourth part, a technologist will draw about 5 cc from the forearm~     on each of the five consecutive days. This is also similar to I-131.~      Initially, all patients will be randomized to one of two study groups. The first group will~     have the I-131 dosimetry performed first followed by the I-124 dosimetry, and the second~     group will have the I-124 dosimetry performed first followed by the I-131 dosimetry.~      The risk of this study is considered very low, and the potential benefits to the patient are~     considered very high.~   "
47329|NCT02947386|"~     This phase I/II trial studies the best dose and side effects of nimotuzumab when giving~     together with nivolumab and to see how well they work in treating patients with non-small~     cell lung cancer that has spread to other places in the body and usually cannot be cured or~     controlled with treatment. Monoclonal antibodies, such as nimotuzumab and nivolumab, may~     block tumor growth in different ways by targeting certain cells.~   "
47330|NCT02947373|"~     This is a single arm pilot trial within the Pacific Pediatric Neuro-Oncology Consortium~     (PNOC).~      The pilot study will look at the safety and toxicity of acquiring hyperpolarized carbon-13~     imaging in children with brain tumors.~   "
47331|NCT02947360|"~     Broad Goal: To demonstrate that focused vascular ultrasound (FOVUS) can accurately risk~     stratify patients with chest pain in the emergency department (ED).~      Background and Rationale: Traditional risk assessment focuses on characteristics of the pain,~     known Coronary Artery Disease (CAD), risk factors, electrocardiogram (ECG), and blood tests~     to identify active ischemia. Identifying clinically significant CAD remains one of the most~     challenging tasks in the ED. Current clinical decision rules err on the side of over~     investigation and admission. To address this limitation, the Investigators have developed a~     point-of-care carotid ultrasound test predictive of CAD. The Investigators have shown that~     carotid plaque is strongly associated with significant angiographic CAD in a population~     referred for angiogram.~      Research Aims:~      Primary - To determine the association between carotid plaque measured by a dedicated~     sonographer and 30-day major adverse cardiac events (MACE), including MI, reperfusion, or~     death in patients presenting to the ED with suspected cardiac ischemia.~      Secondary - To determine the agreement sonographer and emergency physician FOVUS results.~      Methodology: The Investigators propose a prospective cohort study to assess the prognostic~     value of a novel point-of-care carotid ultrasound plaque quantification protocol in the ED of~     Kingston General Hospital. We will enroll 500 consecutive patients presenting with a chief~     complaint of chest pain prompting at least one 12-lead ECG and troponin measurement. Patients~     will undergo carotid scan by a dedicated sonographer and emergency physician. Patients will~     be followed for MACE for 30 days. Those performing scans will be blinded to clinician's~     impression and care plans while clinicians will be blinded to FOVUS findings. The primary~     analysis will involve determination of the sensitivity, sensitivity, positive predictive~     value, negative predictive value and likelihood ratios associated with FOVUS for 30-day MACE.~      Expected Outcomes: The study will provide evidence to determine whether FOVUS may be a useful~     prognostic tool for emergency physicians assessing patients with suspected ischemic chest~     pain. The secondary analysis will provide evidence to determine whether emergency physicians~     can be trained to measure carotid plaque height accurately when compared to the gold standard~     ultrasonographer measurement.~      Significance: If FOVUS can reliably identify very low risk patients, implementation of this~     novel tool could reduce ED length of stay, monitoring, and overcrowding.~   "
47332|NCT02947347|"~     The purpose of this study is to evaluate whether the addition of ibrutinib will result in~     prolongation of progression-free survival (PFS) when compared with rituximab alone in~     treatment naïve subjects with follicular lymphoma.~   "
47333|NCT02947334|"~     This study is a Phase 3, double blind, placebo controlled, randomized, stratified, parallel~     group, multi-center clinical trial designed to compare the efficacy and safety of bococizumab~     150 mg SC Q2wks to placebo for LDL-C lowering in subjects with primary hyperlipidemia or~     mixed dyslipidemia at high or very high risk for CV events. The study will enroll a total of~     approximately 750 subjects from 4 - 5 Asian countries/areas (including China mainland); of~     which approximately 600 subjects will be from sites in China. Subjects will be randomized~     into a bococizumab treatment arm and a placebo arm in a 1:1 ratio.~   "
47334|NCT02947321|"~     Given the benefits of genicular nerve radiofrequency ablation (RFA) in improving pain and~     functional status in non-surgical patients with knee osteoarthritis as well as the high~     prevalence of postoperative pain from total knee arthroplasty (TKA), this study is designed~     to determine the efficacy of preoperative genicular nerve RFA in improving acute and chronic~     postoperative pain as well as functional status in patients undergoing TKA. Patients will be~     randomized to one of two study arms: RFA group (genicular nerve thermal RFA) or control group~     (RFA needles placed in proper location without effective neurotomy).~   "
47335|NCT02947308|"~     This study will examine longitudinal brain development in young adolescent girls with a~     history of Non-Suicidal Self-Injury (NSSI). Specifically, three constructs outlined by the~     the Research Domains Criteria (RDoC) will be examined through self-assessment, MRI, and a~     cognitive battery.~   "
47336|NCT02947295|"~     To develop a rapid, sensitive, and inexpensive diagnostic method, as well as more efficacious~     vaccine, for countries where typhoid fever remains a major public health burden.~   "
47381|NCT02946710|"~     This research will be achieved by the assessment of p75NTR-ECD expression (total and linked~     to different species of Aβ (Aβ1-40 and Aβ-1-42)) within the cerebrospinal fluid (CSF) of~     patients with AD dementia, mild cognitive impairment (MCI) due to AD, frontotemporal dementia~     and non-neurodegenerative dementia.~   "
47337|NCT02947282|"~     The pelvic floor is composed of muscles and connective tissue which acts to provide support~     for pelvic organs, and weakness or injury to the pelvic floor can result in pelvic floor~     dysfunction. Respect for patient autonomy is a guiding principle in medicine and is of~     increasing importance for patients. The PREPARED Trial hopes to demonstrate whether a single~     workshop on pelvic floor health during pregnancy will lead to improved knowledge of pelvic~     floor symptoms postpartum, increase the practice of pelvic floor muscle exercises, increase~     satisfaction with their delivery experience, and change participants preferences and thoughts~     surrounding various modes of delivery.~   "
47338|NCT02947269|"~     Postoperative ileus (POI) refers to the period of gut dysmotility that occurs after abdominal~     surgery. Patients with POI are unable to eat, suffer ongoing nausea and vomiting, are unable~     to open their bowels and have a prolonged hospital stay. Research at ADHB shows that 25% of~     patients will have a prolonged POI after elective bowel resection, which makes it the most~     common major complication after colorectal surgery. Clinicians currently lack a definitive~     medication to prevent or treat POI, which means POI causes patients ongoing morbidity and~     places a significant drain on healthcare resources. Serotonin plays an important role in gut~     motility. Evidence suggests that serotonin agonists, such as prucalopride, increase gut~     transit and may have anti-inflammatory properties. The hypothesis of this study is that~     Prucalopride given pre-operatively and continued post-operatively in patients having an~     elective bowel resection will improve gut function recovery after surgery and reduce POI.~      The investigators' proposed study is a double-blinded randomised controlled trial of~     prucalopride compared to an identical placebo tablet, in patients having an elective bowel~     resection at Auckland City Hospital. Patients will receive a single tablet of Prucalopride or~     placebo 2-3 hours preoperatively and then daily after operation for a maximum of 6 days. The~     primary endpoint will be return to bowel function defined by the time to tolerate a solid~     diet and pass stool. In addition, the investigators plan to assess postoperative gastric~     emptying rates using the safe and non-invasive carbon breath test method. This will allow the~     investigators to determine the effects of prucalopride on the stomach, and support its role~     as a gastric prokinetic.~   "
47339|NCT02947256|"~     Aimed to evaluate laparoscopic cholecystectomy by retro-infundibular (RI) approach compared~     to standard laparoscopic cholecystectomy (SLC) in difficult cases with scarred~     chole-cystohepatic (Calot's) triangle.~   "
47340|NCT02947243|"~     Children with burn injuries experience severe pain intensity during medical procedures~     despite the increasing doses of analgesics. Current guidelines on pediatric procedural pain~     management recommend the combination of non-pharmacological and pharmacological interventions~     to enhance pain management and decrease the numerous side effects of analgesics. Virtual~     reality (VR) has gained growing consideration as a non-pharmacological method as it engages~     multiple senses and allows interactions with a virtual world. Oculus Rift ® is a new~     technology in VR that provides more immersiveness, at a relatively low cost, and could~     probably improve the management of pain and anxiety in burn care. It also has the potential,~     with appropriate custom software designed for burn pediatric patients, to reduce the~     cybersickness symptoms (nausea, dizziness) associated with VR. To the knowledge of the~     investigators, none of the pediatric hospitals across Canada have tested VR as a method of~     pain and anxiety management in children with burn injuries. Overall hypotheses: VR~     distraction via Oculus Rift ® could be an effective method to relieve pain, and anxiety, as~     well as a less traumatizing hospital experience, while promoting a more humanistic care~     environment by combining new technologies (VR via Oculus Rift ®) to standard analgesic~     interventions administered to these children. The expected results will have a direct effect~     on physical (pain) and psychological (anxiety, pain memories) health of the child. In~     addition, clinical implications may include other indicators of quality of care and economic~     benefits such as a wider range of motion of burned limbs and reduction in dosage of opioids~     and anxiolytic drugs administered.~   "
47341|NCT02947230|"~     The McMaster Optimal Aging Portal (the Portal) was launched in 2014 to increase public access~     to trustworthy health information. The Portal helps readers to access evidence-based~     resources; identify trustworthy messages; and understand scientific findings. Now the~     investigators want to know whether using the Portal changes what people know and do to stay~     healthy and mobile.~      This project will help us to:~        1. Understand how middle aged and older adults (age 40+) use the Portal to obtain~          information about maintaining and improving mobility~        2. Evaluate whether use of the Portal results in a change in knowledge about maintaining~          and improving mobility, or change in lifestyle behaviours that may help maintain or~          improve mobility with age.~   "
47342|NCT02947217|"~     In this study the investigators propose a randomized controlled trial to evaluate the effect~     of influenza vaccination on clinical pregnancy rates among women undergoing in vitro~     fertilization.~   "
47343|NCT02947204|"~     The investigators will conduct a study around the best way to monitor infants hospitalized~     with bronchiolitis, the most common lung infection and a leading reason for hospitalization~     in infants. Infants with bronchiolitis have breathing difficulties and are provided~     supplemental oxygen if their oxygen levels are low. However, there is uncertainty regarding~     how to best monitor oxygen levels. A probe placed on the hand or foot can be used to monitor~     oxygen levels all the time (continuous oxygen monitoring) or just every 4-6 hours~     (intermittent oxygen monitoring). Research has suggested that placing infants with~     bronchiolitis on continuous monitoring results in unnecessary use of oxygen and infants~     staying longer in hospital. However, due to the lack of high quality research, its unclear~     which strategy is best and practice varies. The objective of this study is to conduct high~     quality research across hospitals to determine whether intermittent compared to continuous~     oxygen monitoring will reduce the length of hospital stay in infants hospitalized with~     bronchiolitis. The investigators will also compare safety and cost. The results of this study~     will inform bronchiolitis practice standards and the best use of health care resources.~   "
47344|NCT02947191|"~     The purpose of this study is to assess the safety and efficacy of collagen membrane combined~     with human clinical grade umbilical cord mesenchymal stem cells(HUC-MSCs) transplantation in~     patients with chronic nasal septum perforation.~   "
47382|NCT02946697|"~     This study is a randomized controlled trial (RCT) to assess the impact of a culturally based~     social support program (i.e. Joy Luck Academy, JLA) among Chinese American breast cancer~     survivors.~   "
47345|NCT02947178|"~     Femoroacetabular impingement is a pathologic process within the hip joint that results from a~     mechanical discord between the femoral head and neck and the acetabulum that results in~     chronic hip pain, hip labral tears and early progression of osteoarthritis of the hip.1, 2~     Historically an open surgical hip dislocation was performed to treat patients with this~     condition, however with recent advances in arthroscopy, patients more commonly now undergo~     arthroscopic hip surgery. From a pain management standpoint, previous attempts to provide~     peri-operative analgesia included intraarticular or portal analgesic injections. More~     recently, regional anesthesia techniques are being employed to provide more reliable and~     longer lasting post-operative pain control.3, 4 Currently, there are several local~     anesthetics available for regional anesthesia. However, they only provide an average of 12-18~     hours of post-operative pain control following a single injection.5 Bupivacaine is a local~     anesthetic that has been used for many years by multiple routes to control post-operative~     pain. A new formulation of the medication prolongs the release of the active ingredient after~     a single injection and has been shown to result in up to 72 hours of post-operative~     analgesia.6, 7 To the investigator's knowledge, there has not been any studies in the~     literature comparing a historical control local anesthetic to this new formulation of~     liposomal bupivacaine via a fascial iliaca regional soft tissue infiltration blockade to~     provide post operative pain control following hip arthroscopy.~   "
47346|NCT02947165|"~     To characterize the safety and tolerability of NIS793 as single agent and in combination with~     PDR001 and to identify recommended doses for future studies.~   "
47347|NCT02947152|"~     A first-in-human study using HKT288 in solid tumors, including epithelial ovarian cancer and~     renal cell carcinoma~   "
47348|NCT02947139|"~     A randomized, open label, crossover study to explore drug-drug interactions between DWC20155~     / DWC20156 and DWC20161 in Healthy Volunteers~   "
47349|NCT02947126|"~     When developing new medications for lung diseases like Cystic Fibrosis (CF), scientists~     perform lab experiments using cells from the airways, physiology studies of how the lungs~     change when a drug is given, and clinical studies to determine how drugs affect overall~     health. The investigators of this study are seeking to develop computer models that will~     predict how patients will respond to drugs by just doing lab studies on cell samples from~     their noses. Such models would allow for medications to be developed more rapidly for all~     patients and allow treatments to be personalized as well. In order to develop these computer~     models a series of tests will be performed on patients who have CF. Tests will include~     sampling cells from the nose and measuring lung physiology using a combination of different~     imaging, breathing, and other studies performed both before and after participants take a~     therapy. Similar tests will be performed on people who do not have CF, and on the parents of~     the CF participants who carry a single CF gene because this will provide information on how~     specific genes might affect CF lung disease.~   "
47350|NCT02947113|"~     Concurrent chemoradiotherapy is the standard treatment for locally advanced non-small cell~     lung carcinoma (NSCLC). Different chemotherapy and radiation regimens have been advocated but~     in general, cisplatin-doublets are deemed standard of care. Decreasing the overall treatment~     time of irradiation by hypofractionation is thought to increase the efficacy. Extensive~     experience is available on the combination of daily-dose cisplatin in combination with~     hypofractionated radiotherapy. However, no data is available on the safety of cisplatin~     doublets and hypofractionated radiotherapy~   "
47351|NCT02947100|"~     The purpose of this study is to determine the safety of a new formulation of the omega-3~     fatty acids Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA) and to assess whether~     it decreases inflammation and inflammatory pain in children and young adults with Sickle Cell~     Disease.~   "
47352|NCT02947087|"~     Primary objective: To describe and compare the safety and efficacy of treatment with AAT in~     chronic pancreatitis patients who undergo total pancreatectomy and islet autotransplantation~     (TP-IAT).~   "
47353|NCT02947074|"~     Rationale: Healthcare professionals face a growing burden of responsibilities and work~     overload which may cause psychological suffering expressed by burnout, depression and other~     negative psychological variables. Personal behavioral strategies may facilitate the coping~     process. To maintain these positive characteristics, it is necessary that one decouples from~     automatic thoughts, habits and patterns of unhealthy behaviors, leading to behavioral and~     physiological regulation, through mindfulness techniques. More specifically, Yoga is an~     ancient Indian philosophical and practical system and its ultimate goal is to calm the human~     mind, and increase vital capabilities. In addition to the ethical precepts of Yoga, practices~     involve asanas (postures), pranayama (breathing exercises) and dhyana (meditation). Many~     studies have shown the positive effects of Yoga and meditation on psychometric variables,~     however, there are few which address the effectiveness of Yoga on improving psychometric~     variables of health care professionals. Thus, aiming to reduce the symptoms that health care~     professionals experience when they are under burnout, this study intends to use Yoga~     meditation, which may enable the professional to experience decoupling of harmful feelings,~     improving, firstly, one's own inner self-relationship and therefore, with patients and their~     families.~      Objective: To investigate the effects of a 8-week yoga meditation program on psychometric and~     physiological variables of Pediatrics health professionals.~      Methods: randomized controlled clinical trial. Participants: 60 health professionals from the~     Pediatrics Department of a tertiary hospital from Federal University of São Paulo (UNIFESP)~     will be randomized to meditation or control (waiting list) groups. Subjects of the meditation~     groups will have 2 30 min classes a week.~      Evaluations: Psychometric and physiological variables will be accessed at study entry~     (baseline) and after its completion (8-weeks).~      Statistical Analysis: mixed general linear model (intervenient factors: groups - meditation~     vs. control and moment - baseline vs. 8-weeks). Significance accepted with p<0.05.~   "
47354|NCT02947061|"~     To compare the progression free survival(PFS) and safety of TS-S vs. TX-X in Patients With~     Advanced Breast Cancer first-line treatment~   "
47355|NCT02947048|"~     This is a five-arm designed to assess the safety of L1-79 that incorporates 15 prospectively~     randomized, placebo controlled patients and 5 open label patients at either 100 tid or 200~     tid dosing for 28 days. The open label patients will be assessed for the purpose of~     understanding PK/PD and to determine if there are any EKG changes associated with the~     administration of L1-79. Additional safety information will be provided by the 30 patients~     randomized 2:1 active:placebo.~   "
47356|NCT02947035|"~     The research study consists of the participant agreeing to 1) the use of preoperative~     molecular testing (ThyroSeq) to guide extent of initial surgery and 2) the prospective~     collection of medical record data related to treatment of thyroid cancer.~   "
47383|NCT02946684|"~     This project seeks to determine whether estradiol suppression achieved with adjuvant~     treatment with an aromatase inhibitor improves end-follicular and midluteal phase parameters~     during IVF. 128 patients will be randomized to either placebo or active treatment.~   "
47357|NCT02947022|"~     Purpose: There are two goals we have for this prospective single arm study; to see an~     increase in the amount of gadolinium in 24 hour urine collection following each infusion~     treatment with Calcium and Zinc DTPA, and to see a reduction or elimination of gadolinium~     deposition disease (GDD) symptoms.~      Participants: Twenty (20) patients who are suffering from gadolinium deposition disease (GDD)~      Procedures: Over a series of three (3) treatment time-points patients will be treated with IV~     Ca-DTPA on day one, and Zn-DTPA on day two.~   "
47358|NCT02947009|"~     Exercise-induced paradoxical vocal fold motion disorder (E-PVFMD) - which severely impacts~     the lives of up to 1 million adolescents in the U.S. annually - is under- or mis-diagnosed in~     as many as 80% of cases, leading to ineffective, protracted periods of management.~     Additionally, what makes those with the condition different from those at risk for the~     condition (e.g., playing sports/engaging in athletic activity within a competitive athletic~     environment) is unclear. The goals of this proposed study are to address this diagnostic~     challenge by (1) pursuing a previously published preliminary taxonomic algorithm for the~     clinical identification and classification of EPVFMD, and by (2) elucidating potential~     underlying mechanisms driving this clinical presentation. Study outcomes will improve~     sensitivity and specificity of diagnosis protocols for PVFMD, thereby reducing prevalence of~     misdiagnosis and improving clinical management in individuals with this disorder in the~     future. Outcomes will also be used to create preventative care measures for adolescents at~     risk for the condition.~   "
47359|NCT02946996|"~     The purpose of this study is to look at the effects that the study drugs (metformin and OPC)~     have on AGE levels in patients with prostate cancer.~   "
47360|NCT02946983|"~     The investigators will test whether a subliminal, intragastric dose of fructose is able to~     influence the emotional state at the behavioural and neural level, as has been previously~     shown for fatty acids. They will also examine the potential involvement of gut peptide~     release. Based on previous research using fatty acids, an attenuating effect of fructose~     compared to placebo on the induced negative emotional state is hypothesized at the~     self-report as well as the brain level.~   "
47361|NCT02946970|"~     The investigators aim to study the brain mechanisms underlying the effect of subliminal (not~     consciously perceived) intragastric administration of bitter tastants on hunger and food~     intake, which was previously found. The investigators will assess brain activation patterns~     after an acute intragastric administration of Quinine-hydrochloride versus saline on two~     different test days, and will simultaneously assess a putative role of altered gut peptide~     release in these effects. The hypothesis is that intragastric infusion of a bitter agonist~     will decrease the activity in homeostatic and hedonic brain regions and that this effect is~     mediated by gut peptide release.~   "
47362|NCT02946957|"~     Osteoarthritis (OA) pain affects 50 percent of older adults, more than half of whom also~     experience significant sleep disturbance. This randomized trial will determine whether a~     telephone-based cognitive behavioral treatment targeting insomnia in older adults with~     chronic severe OA-related insomnia and pain results in substantially greater reductions in~     insomnia severity and in related improvements in pain, fatigue, mood, quality of life and~     healthcare costs compared to telephone-delivered education (attention control) about~     insomnia. The trial will test an intervention that if demonstrated to have long term efficacy~     is scalable and has the potential for wide-scale deployment in healthcare systems.~   "
47363|NCT02946944|"~     Pilot randomized study of the sidlenafil efficacy in combination with oral anticoagulants in~     the treatment of patients with intermediate-high risk of pulmonary embolism~   "
47364|NCT02946931|"~     To evaluate safety and effectiveness of Prizbind® for Intravenous Solution 2.5 g under~     Japanese clinical condition~   "
47365|NCT02946918|"~     In some patients, levothyroxine liquid gel capsules may demonstrate superior absorption than~     the tablet option. Impaired absorption of thyroid hormone directly correlates to higher and~     more unpredictable TSH (thyroid stimulating hormone) levels.~      The investigators therefore hypothesize that following thyroidectomy for Stage I/II~     differentiated thyroid cancer the gel capsule levothyroxine formulation will provide more~     predictable TSH results and in turn require fewer dose adjustments to achieve optimal hormone~     levels in the postoperative period.~      The aim of this investigation is to compare the use of levothyroxine in liquid gel capsules~     to tablet form for TSH suppression following thyroidectomy for presumed stage I/II~     differentiated thyroid cancer.~   "
47366|NCT02946905|"~     Cognitive impairment is a poorly understood, serious, and emerging complication for adult~     patients with sickle cell disease. Because there is extensive microvascular damage from~     oxidative damage in sickle cell disease, the investigators hypothesize that this is also~     present in the cerebral microvasculature to cause cognitive impairment. The investigators~     plan to test this by correlating markers of inflammation and oxidative damage with cognitive~     performance and 7 Tesla brain MRI microvascular findings in these patients, with the long~     term goal of understanding the mechanisms and risk factors of cognitive impairment in sickle~     cell disease.~   "
47367|NCT02946892|"~     This study evaluates the effect of carvedilol in patients who have undergone a Fontan heart~     operation. All participants will receive carvedilol and placebo for 12 weeks. Exercise tests~     will be performed at the end of each 12 week period.~   "
47368|NCT02946879|"~     This study is a longer-term follow-up study for patients who have been administered~     AAV2/5-OPTIRPE65 in the Phase I/II, open label, non-randomised, two-centre, dose escalation~     trial in adults and children with retinal dystrophy associated with defects in RPE65.~   "
47369|NCT02946866|"~     The aim of this prospective study is to reveal the natural history of symptomatic hemorrhage~     in adult patients with cerebral cavernous malformation with the goal of informing the~     treatment plan.~   "
47370|NCT02946853|"~     Cardiac resynchronization therapy (CRT) is a demonstrably effective device intervention for~     patients with heart failure with reduced ejection fraction and specific indication. However,~     many patients with heart failure (HF) are unable to maintain sinus rhythm and approximately~     30-36% of CRT patients are in atrial fibrillation (AF).~   "
47371|NCT02946840|"~     Endoscopic ultrasound-guided fine-needle aspiration biopsy (EUS-FNA) is a reliable, safe, and~     effective technique for obtaining samples from pancreatic masses. A new core biopsy needle~     has been developed by Beacon bnx® (Medtronic, Newton, MA) that allows the possibility to~     achieve a core for histology evaluation and the interchangibility of needle size using the~     same needle shelter and different needle sizes.~   "
47372|NCT02946827|"~     FODMAPS (fructose, oligosaccharides, monosaccharides, disaccharides and polyols) are~     characterised as fermentable but poorly absorbed carbohydrates which enter the colon and are~     utilised by colonic bacteria. During fasting colonic nutrients are scarce but ingesting~     FODMAPS causes a rapid increase in carbohydrate which can overwhelm the microbiota's ability~     to utilise substrate. The excess reducing equivalents will generate hydrogen or methane. The~     principal symptoms are diarrhoea and abdominal distension. Patients with irritable bowel~     syndrome appear to benefit by restricting intake, possibly because they are hypersensitive to~     intestinal distension.~      The focus of the study is to evaluate if in celiac patients with persistent abdominal~     symptoms and with a correct gluten free diet, a low FODMAPs diet can improve their symptoms.~     Moreover the study would like to observe if a dietary restriction in FODMAPs carries the risk~     of nutritional inadequacy.~   "
47373|NCT02946814|"~     This study aims to evaluate the in situ antibacterial activity of a mouthwash containing~     essential oils with and without alcohol on undisturbed de novo plaque-like biofilm~     (PL-biofilm) up to 7 h after its application.~      An appliance was designed to hold six glass disks on the buccal sides of the lower teeth,~     allowing PL-biofilm growth. Twenty healthy volunteers will the appliance for 48 h and then~     performed a mouthwash with essential oils. Disks will be removed after 30 s and at 1, 3, 5,~     and 7 h later. After a washout period, the same procedure will be repeated with a sterile~     water mouthwash and a mouthwash with essential oils without alcohol. After PL-biofilm vital~     staining, samples will be analyzed using a confocal laser scanning microscope analysing their~     bacterial viability and thickness.~   "
47374|NCT02946801|"~     The accumulation and maturation of oral biofilm in the gingival margin is widely recognised~     to be the primary aetiological factor in the development of chronic gingivitis. Based on this~     association, the current treatment of gingivitis is focused on biofilm disruption, which will~     normally include mechanical processes, both professionally and at home. However, for~     patients, it is not easy to achieve a proper level of plaque control. The efficient plaque~     control techniques are very time consuming and require a special motivation and skills for~     their optimum use. It was at this point where mouthwashes become important, due to the fact~     that they include diverse types of antimicrobial agents to complement the results of~     mechanical oral hygiene measures.~      The essential oils have been presented as a realiable alternative to the gold Standard~     (Chlorhexidine). However, it use has been limited clinically due to their alcohol contain.~     Some years ago, a new alternative without alcohol has been launched to the market. This~     formulation has not been already deeply tested specific antiplaque studies in which the~     structure of the biofilm remained intact.~      The aim of this study was to evaluate the in situ antiplaque effect of 2 antimicrobial agents~     (based on an essential oils formulation with and without alcohol) in the short term with a~     posterior analysis on non-destructured biofilm with Confocal Laser Scanning Microscope~     combined with fluorescence staining.~   "
47375|NCT02946788|"~     This is a multi center open label study intended to provide photo documentation and time to~     response data for BPX-01 1 and 2% minocycline topical gel for the treatment of moderate to~     severe non-nodular inflammatory acne vulgarism.~   "
47376|NCT02946775|"~     To define the etiologic agents of community acquired bacteremic syndromes (defined as~     septicemia, bacteremia, pneumonia and/or meningitis) in a malaria endemic setting.~   "
47377|NCT02946762|"~     At correctional facilities in Zambia and South Africa, a cross-sectional study design will be~     used to characterize the full continuum of integrated HIV/TB care under Treatment as~     Prevention (TasP), and will enrich this approach by: 1) using individual-level cohort data~     for HIV-infected inmates to assess ART uptake under TasP/Universal Test and Treat (UTT), as~     well as 6-month virological suppression and retention in care for inmates initiating ART; and~     2) mixed methods to identify health-system, corrections-related socio-cultural and~     individual-inmate barriers to and facilitators of TasP/UTT to refine TasP implementation; and~     3) conducting a retrospective chart review using routine data from Ministry of Health~     registers to reconstruct an approximate HIV and TB cascade for all inmates (HIV-infected and~     HIV-uninfected) at 3 and 12 months into TasP/UTT implementation.~   "
47378|NCT02946749|"~     As the two-child policy implementation, caesarean women's clinical pregnancy is a huge~     problem again, Especially the placenta planting abnormal disease is a serious threat to the~     maternal health and life. Through this research, the investigators can obtain relevant~     epidemiological data and provide objective data for the department of public health policy;~     Predicting an placenta abnormal planting early diagnosis model was constructed, it will fill~     the blank in this field, and high-risk groups in the early stages of pregnancy will be taken~     proper disposal, the related complications will be reduced to ensure the safety of maternal.~   "
47379|NCT02946736|"~     This study is a randomized controlled trial that will assess the effects of (1) the~     Family-Supportive Supervisor Behavior (FSSB) and Sleep Leadership training and (2)~     sleep/cognitive effectiveness feedback intervention on health and well-being among full-time~     employees in the Oregon National Guard, their supervisors, and their families. The~     interventions involving both health protection and health promotion are expected to~     contribute to improvements in employees' and their supervisors' sleep, risk behaviors, mental~     and physical health, and injury, as well as employees' and their spouse/partners' family~     experiences, health and well-being, and workplace outcomes.~   "
47380|NCT02946723|"~     Overactive bladder(OAB,Urgency) was determined by International Continence Society as Urinary~     urgency, usually accompanied by frequency and nocturia, with or without urgency urinary~     incontinence, in the absence of urinary tract infection (UTI) or other obvious pathology.The~     SNM treatment involves a two-stage surgical procedure performed under local anesthesia. The~     device include IPG (implantable programme generator) and lead. In the initial test phase, 1st~     stage, electrode is placed near the sacral nerve and requires a 2 weeks assessment. This~     allows your doctors and you to assess your initial response according to your voiding dairy~     and satisfaction. In 2nd stage, SNM procedure is implantation of the IPG.~      X ray guidance is harmful to both patients and doctors, while ultrasound guidance is real~     time visual guidance ,easy to operate by doctors and a radiation free option to challenge~     anatomy. Urologists are skilled in both ultrasound operations and anatomy basics and~     dedicating to developing better guidance technique in surgery.~      The study here compare the efficacy and safety of ultrasound versus X ray guidance technique~     in SNM.~   "
47385|NCT02946658|"~     Chronic Obstructive Pulmonary Disease (COPD) is a lung-related disorder that is characterized~     by long-term, often progressive state of poor airflow. Primary symptoms include low oxygen~     tension, shortness of breath, productive cough, and broncho-pulmonary inflammation and~     interference with oxygen-carbon dioxide exchange.~      Air pollution and tobacco smoking are felt to be the most common cause of these issues.~     Diagnostic testing is based on poor airflow measured by lung function studies and whose~     symptoms do not improve much with antiasthma bronchodilators.~      Study is an interventional study to document the safety and efficacy of use of AD-cSVF in~     chronic broncho-pulmonary disease groups.~   "
47386|NCT02946645|"~     Temporomandibular joint dysfunction (TMD) therapy remains an open challenge for modern~     dentistry. Usually physiotherapy is considered a reliable approach to treatment of TMD~     patients. Moreover, neuromuscular bites (orthotic) are able to reduce signs and symptoms of~     TMD. To our knowledge, no specific trials have been designed for the evaluation of the~     efficiency of physiotherapy vs neuromuscular bites in TMD patients.~      The aim of this trial is to evaluate the efficiency in term of cranial muscles~     electromyography (sEMG), mandibular kinetic (KNG) and subjective pain scores, of orthotic vs~     manual physiotherapy therapy compared to placebo.~   "
47387|NCT02946632|"~     In this study, the investigators will assess the efficacy and tolerability of a novel,~     initial triple combination therapy with metformin, saxaglipitin, and dapagliflozin, compared~     to conventional stepwise add-on therapy in drug-naïve patients with recently onset type 2~     diabetes.~   "
47388|NCT02946619|"~     This study is a randomized controlled trial (RCT) with the aim of determining the cultural~     sensitivity, feasibility, and effectiveness of an expressive writing intervention for Chinese~     breast cancer survivors.~   "
47389|NCT02946606|"~     This is a randomized, active-controlled, open-label, sequential dose group, Phase 1b/2 study~     designed to assess the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics~     of weekly and every other week doses of GX-H9 in the treatment of AGHD.~   "
47390|NCT02946593|"~     The purpose of the study is to examine the feasibility of the program and data collection~     protocol to plan a multisite clinical trial. The program, Stroll Safe, an outdoor fall~     prevention program, will take place in the lab space of the New York University occupational~     therapy department and in the surrounding neighborhood.~      Twenty-four people who meet the inclusion criteria will be enrolled after informed consent.~     Recruitment will include follow up with people who expressed interest in the fall prevention~     program during a survey study conducted by the PI, and interested members of community-based~     programs for seniors who have agreed to be community partners for this study. Twelve~     participants will be assigned to the 7-week program and 12 will receive written information~     on outdoor fall prevention (control group).~      The topics addressed in the once a week, 7-week outdoor falls prevention program, for which a~     treatment manual has been developed, are based on the results of a survey conducted of~     community dwelling older adults that identified gaps in knowledge and use of prevention~     strategies, and the related literature. The program includes pre-set modules, however,~     participants will be able to voice individual concerns and problem-solve solutions during~     group discussions. Using an ecological perspective, the Health Belief Model, and problem~     solving theory as a guide, the intervention will include a didactic component, group problem~     solving, practical application of strategies, and self-advocacy regarding reporting problems~     to the city.~      Analysis will primarily focus on process measures.Post-intervention, semi-structures~     interviews will be conducted and analyzed to assess strengths/limitations of the program and~     participant's attribution of any behavioral changes to the intervention. Although statistical~     significant is not anticipated in this small feasibility study, repeated measures ANOVA will~     be used to examine changes in Falls Efficacy Scale-International (FES-I), Outdoor Falls~     Questionnaire (OFQ) and Falls Behavioral Scale for the Older Person (FaB) scores from pre to~     post-test for the treatment and control groups. Effect sizes (Cohen's d) will also be~     calculated. Change in number of stumbles, trips, slips, and falls before and after the~     program will also be analyzed.~      Data will be collected on falls self-efficacy and strategy use at study enrollment~     (Baseline), after completion of the 7 week program (1st Post-test), and at 2 months~     post-program completion (2nd Post-test). Participants will be asked to keep daily diaries of~     stumbles, trips, slips, and falls from the time they enroll in the study until two months~     following the completion of the program.~   "
47391|NCT02946580|"~     Constipation is a known complication of the postoperative period after spinal surgery, where~     prescription pain medicines called opioids are traditionally used in high doses for the~     treatment of surgery-related pain. The goal of this study is to determine the effectiveness~     of Movantik (naloxegol)—a FDA-approved drug used to treat constipation that is caused by~     opioids—in preventing constipation in patients undergoing spinal fusion surgery at MGH.~   "
47392|NCT02946567|"~     The investigators are studying the educational potential of games, with the goal of~     developing a game to improve learning and promote healthy hearing behaviors.~      The project is looking for adolescents and young adults that play games to share their~     experience and learning from playing games.~      The investigators ask participants to fill out an enrollment form/informed consent, complete~     surveys on healthy hearing habits, and play a game provided by the project.~      This projects aims the development and evaluation of a game to educate teenagers and young~     adults about noise-induced hearing loss, enhance knowledge about hearing, and promote healthy~     hearing behaviors with the potential to improve hearing health care.~   "
47393|NCT02946554|"~     The study will assess the safety of different dose regimens of HepaStem in cirrhotic Patients~     with ACLF or with acute decompensation at risk of developing ACLF up to Day 28 of the active~     study period.~   "
47394|NCT02946541|"~     This is a randomized, double-blind, placebo-controlled, phase III clinical trial to~     investigate the efficacy and safety of evogliptin after oral administration in patients with~     type 2 diabetes who have inadequate glycemic control on diet and exercise.~   "
47395|NCT02946528|"~     Within the last decade, urgent-start peritoneal dialysis(PD) has gained considerable interest~     amongst nephrologists. Several publications have provided assurances that urgent-start PD is~     indeed feasible and can serve patients well; however, most of the studies have small sample~     sizes, retrospective design, and the impact of the urgent-start dialysis modality on outcome,~     especially on short-term complications, has not been directly evaluated. Therefore, we~     started this multi-centered, prospective, interventional study compared the dialysis-related~     complications and survival rate directly between urgent-start PD and HD groups with a large~     sample to determine the feasibility and safety of urgent-start PD as an alternate initial~     modality of dialysis for patients who require urgent initiation of dialysis therapy.~   "
47396|NCT02946515|"~     This study is looking at the feasibility and efficacy of using SIMmersion's PeopleSim~     technology to train providers through role playing simulations to effectively conduct~     discussions with parents to provide intervention for, and reduce the likelihood of~     progression to childhood obesity.~   "
47397|NCT02946502|"~     The purpose of this study is to test the association between ICU acquired weakness as~     evaluated by dominant handheld dynamometry (handgrip) and the mechanical ventilation weaning~     outcome~   "
47398|NCT02946489|"~     Cannabis use disorders remain a significant public health problem. The pharmacological~     facilitation of behavioral treatment represents a promising strategy for addressing~     disordered cannabis use. Cannabis use disorders are recognized to be associated with various~     vulnerabilities that complicate the course of treatment and that may be amenable to glutamate~     modulators. The purpose of this randomized, double-blind, controlled trial is to test various~     glutamate modulators in conjunction with motivational enhancement therapy (MET) and~     mindfulness based relapse prevention (MBRP) for cannabis use disorders.~   "
47399|NCT02946476|"~     To better understand the public health prognostic impact of noncardiac chronic illnesses, we~     explored the attributable risk of noncardiac comorbidities on outcomes between heart failure~     patients with reduced ejection fraction (HFREF) and heart failure patients with preserved~     ejection fraction (HFpEF) in a large contemporary heart failure (HF) population The adjusted~     hazard ratio (HR) and the population attributable risk were used to compare the contributions~     of 15 noncardiac comorbidities to adverse outcome. The comorbidities that contributed to high~     attributable risk were: anemia, chronic kidney disease, chronic obstructive pulmonary~     disease, diabetes mellitus, and peripheral artery disease. These findings were similar for~     HFrEF and HFpEF groups. Interaction analysis confirmed similar results.~   "
47400|NCT02946463|"~     The purpose of this study is to assess ALXN1210 compared to eculizumab in adult patients with~     PNH who have not previously used a complement inhibitor.~   "
47401|NCT02946450|"~     The purpose of this study is to assess safety of Omnipure inj. (lohexol) contrast media in CT~     scanning patients~   "
47402|NCT02946437|"~     Feasibility and safety of short term application of sevoflurane in patients with SAH treated~     with aneurysm coiling or clipping in the setting of a neurointensive care unit.~   "
47403|NCT02946424|"~     This is a double blind, randomized, placebo -controlled clinical trial with the primary goal~     of determining the osteogenic benefits of simvastatin in acute SCI.~   "
47404|NCT02946411|"~     The study is designed to test if there is any correlation between the glucose levels in the~     postoperatory period and the length of hospital stay.~   "
47405|NCT02946398|"~     Procedures for identification of high-risk elderly patients in the emergency department are~     lacking.~      We aim to identify early risk factors associated with an adverse outcome in elderly patients~     who visit the emergency department (ED). Second, we aim to find practical tools to identify~     those elderly patients who are at risk for an adverse outcome in an early stage (by applying~     and testing triage and risk stratification scores, clinical impression and laboratory~     results).~      With the results of this study, we intend to develop a clinical prediction model to identify~     older emergency department patients with an increased risk of adverse outcomes.~   "
47406|NCT02946385|"~     The purpose of this study is to compare the effectiveness of 2 (given at 0, 2 months) or 3~     (given at 0, 2, 6 months) doses of the GSK MenABCWY vaccine administered to healthy~     adolescents in study V102_15 (NCT02212457), against a panel of randomly selected U.S. N.~     meningitidis serogroup B invasive disease strains at 24 months after the last meningococcal~     vaccination in V102_15 (NCT02212457) and response to a booster dose.~   "
47407|NCT02946372|"~     Macular hole is an infrequent retinal pathology (2 to 4/1000) which most often affects people~     aged over 60, and twice common in women than men.~      The vast majority of cases are idiopathic. Without treatment, the macular hole evolves~     through a series of stages until the extension of the diameter (up to 500 microns and higher~     values). With a fully developed macular hole, patients complain of metamorphopsia and~     decreased visual acuity.~      This pathology has clearly benefited from advances in microsurgery and better understanding~     of its pathophysiology. Macular hole treatment has evolved to include small-gauge pars plana~     vitrectomy with or without internal limiting membrane (ILM) peeling and placement of~     intraocular gas tamponade.~      The postoperative closure rate is close to 80%, but strongly depends on the initial~     characteristics of the hole, its diameter remaining the main prognostic factor. Thus for~     macular holes <400 microns, the closure rate is close to 92% dropping to 56% for macular~     holes above 400 microns. In case of surgical failure, one or more reoperations can be~     proposed, but with a lower closure rate.~      The quest for a surgical technique presenting a greater success rate is a common goal to all~     retinologists.~      Here the investigators propose a new surgical technique, derived from the FLAP method, and~     consisting of an inner limiting membrane transposition.~      The objective of this study is to evaluate the feasibility of a new surgical technique for~     the treatment of macular holes already operated but without macular hole closure, allowing~     these patients a new therapeutic alternative. The success of this technique will be confirmed~     by detecting postoperatively the presence of the transposed internal limiting membrane into~     the foveal region.~   "
47408|NCT02946359|"~     This is a phase II, prospective, single arm, non comparative study with crizotinib combined~     with bevacizumab in treatment-naive lung adenocarcinoma cancer patients with ALK~     translocation or ROS1 translocation or MET amplification~   "
47409|NCT02946346|"~     Most genital infections by human papillomaviruses (HPV) are asymptomatic or benign and clear~     within a few months or years. There infections are much less studies than chronic infections,~     even though they represent the main reservoir for the virus. The goal of this project is to~     decipher the kinetics of the virus and of the host immune response in acute HPV genital~     infections in your women. This will be performed by following women longitudinally and~     regularly in order to measure variations in virus load, immune cell count, cytokine~     concentration and antibody titers. The investigators will also investigate the interaction~     between these kinetics and host genetics and host vaginal microbiota~   "
47410|NCT02946333|"~     Those patients with newly diagnosed Multiple Myeloma (MM) who are not candidates for~     Autologous Stem Cell Transplant (ASCT) and who meet the screening criteria described in this~     protocol can participate. The participating patients must sign an informed consent, which the~     investigator who will collect the study variables in an electronic case report form (eCRF)~     will provide to them. The investigators must recruit at least 450 patients in a 24-month~     period.~   "
47411|NCT02946320|"~     The purpose of this study is to determine the optimal way of predilatation for BVS~     implantation.~   "
47412|NCT02946307|"~     The purpose of this study is to evaluate the efficacy and safety of RESTORE Paclitaxel~     eluting balloon in the treatment of Chinese patients with coronary heart disease and small~     vessel lesions in comparison with RESOLUTE Zotarolimus eluting stent.~   "
47414|NCT02946281|"~     The primary objective of Do CHANGE is to develop a health ecosystem for integrated disease~     management of citizens with high blood pressure and patients with ischemic heart disease or~     heart failure. The system will give them access to a set of personalized health services in a~     near real-time fashion. This disruptive system will incorporate the behaviour change methods,~     such as Do Something Different, in conjunction with new innovative wearable/portable tools~     that can monitor behaviour and clinical parameters in normal living situations.~   "
47415|NCT02946268|"~     The purpose of this study is to determine the ideal delivery of local anesthetics for pain~     control when using continuous interscalene peripheral nerve catheters for shoulder surgery.~      The study will be conducted in three stages. In the first stage the ideal bolus volume of~     ropivacaine will be determined. In the second stage the optimal rate of delivery of the bolus~     (infusion rate) will be determined. Finally, once both the ideal volume and infusion rate has~     been determined, the optimal interval between boluses of local anesthetic will be determined.~   "
47416|NCT02946255|"~     The investigators propose to examine the effectiveness of a brief intervention that might~     better facilitate the transition into the community for people with schizophrenia. The~     intervention is called the Welcome Basket. It involves Peer Support Workers connecting with~     and supporting hospitalized individuals in the days before discharge and again in the~     community in the first month immediately following discharge. The investigators will compare~     the outcomes of discharge from hospital as usual with the full version of the welcome basket~     and a preliminary test of an abbreviated 2 visit version of the intervention.~   "
47417|NCT02946242|"~     Ultrasound devices components and accessories are under continuous development in order to~     optimize, validate and improve the devices, including improving the quality of images. In~     this study, GEHC proposes to collect data in order to achieve the following~        1. Aim 1: Perform iterative evaluations of the device (including features, accessories and~          components) to optimize device performance, assess feasibility of new features, and to~          perform testing necessary to support product and technology development;~        2. Aim 2: Perform activities to support design validation and/or to confirm user~          requirements and specifications have been met, as per design controls and other~          applicable requirements;~        3. Aim 3: Evaluate device complaints and analyze potential causes. There is no animal or~          phantom model that is adequate to accomplish these aims; therefore human subjects are~          required.~      Due to the inherently varied nature of study data, specific data points will be recorded on a~     per-case basis and the study final report will summarize at minimum number and type of study~     scans conducted. Electronic image data may be collected. The number and type of safety~     issues, including adverse events (AEs) and serious adverse events (SAEs) will be reported.~     Unexpected device issues that occur outside of expected and controlled engineering~     optimization will be reported.~   "
47418|NCT02946229|"~     The purpose of this study is to enable longitudinal data collection of a library of~     ultrasound images and associated case data in a diseased population with varied sonographic~     findings. This data is required to support future engineering development of new ultrasound~     technologies.~   "
47419|NCT02946216|"~     The study aims to explore the prevalence of ALK/ROS1/MET mutations assessed with ctDNA~     samples in EGFR-wildtype NSCLC~   "
47420|NCT02946203|"~     In this research study, two different oral contrast materials that can be used for CT or MR~     enterography will be studied. This study is designed to compare which oral contrast material~     (VoLumen or Breeza) is preferred by pediatric patients and which provides higher quality~     exams.~   "
47421|NCT02946190|"~     This is a phase II, randomized double-center, and observer-blind controlled pilot vaccine~     trial in 11 to 15 years old healthy subjects to assess the immunogenicity of the genetically~     detoxified pertussis toxin (rPT) included in a novel acellular pertussis vaccine (Pertagen®)~     manufactured by BioNet-Asia when delivered by the intramuscular route to adolescents~     previously primed and boosted with chemically-detoxified PT, along with Td-pur® and in~     comparison with that of Boostrix® dTpa.~      At Day 0, eligible volunteers will undergo a venous bleed for the determination of baseline~     values and enter the randomization scheme, being allocated to one of two groups: A (Pertagen®~     + Td-pur®), B (Boostrix® dTpa).~      Randomized participants will receive one dose of Pertagen® and Td-pur® (Group A) or 1 dose of~     Boostrix® dTpa (Group B) by intramuscular injection in the deltoid. All subjects will be~     observed in the Plateforme de Recherché Pédiatrique for 30 minutes after immunization.~      Post-immunization local and systemic reactions will be followed up for 7 days after~     immunization. Adverse events will be followed for 28 days after immunization.~      At Day 28, a second visit (study end visit) will take place for safety evaluation and blood~     draw for immunogenicity evaluation.~      Blood draws performed on Day 0 (Baseline) and Day 28 will be used to evaluate immune response~     to study vaccines.~      The primary statistical analysis will be performed with visit 2 (Day 28) data to compare the~     immunogenicity and safety of one dose of Pertagen®, given simultaneously with Td-pur®, to~     those elicited by Boostrix® dTpa.~   "
47422|NCT02946177|"~     In this study the investigators propose a randomized controlled trial to evaluate the effect~     of influenza vaccination on clinical pregnancy rates among women undergoing in vitro~     fertilization as donor egg recipients.~   "
47423|NCT02946164|"~     This study is a pilot evaluation of 'Stick To It', a behavioral intervention based on the~     concept of gamification. The objective of the program is to encourage young men who have sex~     with men (MSM) to be regularly screened for HIV and sexually transmitted infections (STIs)~     and to adopt safer sexual behaviors, with the ultimate goal to decrease HIV and STI~     incidence. Gamification is the application of game elements, like points, badges, and~     rewards, to non-game settings.~   "
47424|NCT02946151|"~     The study is a two-phase study, which aims to investigate the performance of a novel~     electrode type in detecting epileptic seizures. The electrode is designed for subcutaneous~     implantation with long-term monitoring in mind.~   "
47425|NCT02946138|"~     The aim of this research project is to assess the efficacy and toxicity of hypofractionated~     carbon-ion radiotherapy with concurrent granulocyte-macrophage colony-stimulating factor for~     the treatment of hepatocellular carcinoma~   "
47426|NCT02946125|"~     This is a Phase 2 study to investigate the safety, efficacy and pharmacokinetics of EYN-1601~     for dilation of the pupil. A single microdose of EYN-1601 will be compared to single doses of~     commercially available phenylephrine hydrochloride 2.5% and 10% ophthalmic solutions.~   "
47430|NCT02946073|"~     This study will be a Phase III, placebo-controlled, multicenter study with an~     enriched-enrollment withdrawal design to evaluate the efficacy and safety of CAM2038 in~     opioid-experienced subjects with moderate to severe CLBP that requires continuous,~     around-the-clock (ATC) opioid treatment. The study will comprise 5 phases: a Screening Phase~     (up to 2 weeks), a Transition Phase (up to 2 weeks), an open label Titration Phase (up to 10~     weeks), a Double-Blind Phase including a Final Study Visit (12 weeks), and a Follow-up Phase~     (4 weeks). The overall duration of participation will be up to 32 weeks, from Screening Phase~     to Follow up Phase, including 12 weeks of double-blinded treatment.~   "
47431|NCT02946060|"~     This study (MAINTAIN -II) aims to examine the effect of audio playlists [with or without~     Rhythmic Auditory Stimulation (RAS)] on the weekly volume of physical activity. Participants~     will be randomized into 3 Interventions: Control (standard, usual care), Audiobook, or~     Tempo-pace Synchronized Playlists (TSP). The investigators also aim to explore the effects of~     these interventions on mood, perceived exertion and dissociative attention among patients~     participating in cardiac rehabilitation.~   "
47432|NCT02946047|"~     The goal of this study is to determine the safety and tolerability of Ixazomib in HIV~     infected patients who are on a stable regimen of ART that suppresses HIV replication. A~     secondary goal is to determine the effect of ixazomib on the size of the HIV reservoir.~   "
47433|NCT02946034|"~     Single arm, open-label experimental trial of 12 weeks of Viekira Pak treatment ± ribavirin~     for adults with chronic kidney disease and hepatitis C.~   "
47434|NCT02946021|"~     Assessment of lymphatic structure and function pre- and post- treatment and during recovery~     in head and neck cancer related lymphedema patients using NIR fluorescence lymphatic imaging:~     Response to ICD therapy in HNC Patients.~   "
47435|NCT02946008|"~     This is a single-arm prospective non-randomized, non-blinded trial to assess the safety of~     neoadjuvant stereotactic body radiation therapy (SBRT) before surgery in high risk prostate~     cancer patients.~      Radiation therapy will be delivered over 5 treatment sessions for approximately 1.5 weeks~     total.~   "
47436|NCT02945995|"~     The purpose of the study is to evaluate outcome after arthroscopy if the hip in patients~     previous treated with periacetabular osteotomy~   "
47437|NCT02945982|"~     Portal hypertension is a common pathology in chronic liver disease, particularly in liver~     cirrhosis. Hepatitis B Virus (HBV) is one of most etiologies of liver cirrhosis in China. The~     basic reason for portal hypertension in HBV is the largely deposition of hepatic~     extracellular matrixes which causes high pressure in liver vessels. One of the most common~     symptoms of cirrhotic portal hypertension is gastroesophageal varices.The effective~     inhibition of HBV can partially stop or reverse liver fibrosis in patients with chronic~     Hepatitis and liver cirrhosis due to HBV and the anti-fibrotic strategy focusing on the~     regulation of hepatic extracellular matrix may have a great benefit. Therefore, antivirals~     therapy is also a basic treatment for low-grade cirrhotic portal hypertension. Fuzheng Huayu~     has been found to enhance the degradation of collagens in fibrotic liver and have a good~     action against liver fibrosis in patients with chronic hepatitis B. However, there are no~     high quality clinical evidences which can demonstrate if the combination of anti-viral and~     anti-fibrotic therapy can relieve the pressure of liver vessels and decline incidence rate~     and bleeding rate of gastroesophageal varices.~   "
47438|NCT02945969|"~     The proposed randomized controlled trial will test the effect of dietary sodium reduction on~     albuminuria in patients with proteinuric chronic kidney disease. Results from this study will~     clarify the role of dietary sodium reduction in management of patients with proteinuric~     chronic kidney disease and its potential to halt the progression of chronic kidney disease.~   "
47439|NCT02945956|"~     Portal hypertension is a common pathology in chronic liver disease, particularly in liver~     cirrhosis. Hepatitis B Virus (HBV) is one of most etiologies of liver cirrhosis in China. The~     basic reason for portal hypertension in HBV is the largely deposition of hepatic~     extracellular matrixes which causes high pressure in liver vessels. One of the most common~     symptoms of cirrhotic portal hypertension is gastroesophageal varices.The effective~     inhibition of HBV can partially stop or reverse liver fibrosis in patients with chronic~     Hepatitis and liver cirrhosis due to HBV and the anti-fibrotic strategy focusing on the~     regulation of hepatic extracellular matrix may have a great benefit. Therefore, antivirals~     therapy is also a basic treatment for low-grade cirrhotic portal hypertension. Fuzheng Huayu~     has been found to enhance the degradation of collagens in fibrotic liver and have a good~     action against liver fibrosis in patients with chronic hepatitis B. However, there are no~     high quality clinical evidences which can demonstrate if the combination of anti-viral and~     anti-fibrotic therapy can relieve the pressure of liver vessels and decline incidence rate~     and bleeding rate of gastroesophageal varices.~   "
47440|NCT02945943|"~     Our purpose was to examine the combined effects of thrust mobilization of the proximal and~     distal ankle joints in conjunction with a six-week rehabilitation program on ankle function~     in subjects reporting chronic ankle instability (CAI).~   "
47441|NCT02945930|"~     To observe the Safety and Efficacy of Compont Medical Glue in the Treatment of~     Esophagogastric Varices.~   "
47442|NCT02945917|"~     The use of esophageal balloon catheter to estimate pleural pressure has gained renewed~     popularity in recent years. Indeed, measurement of transpulmonary pressure may allow a more~     pathophysiological-based approach to ventilator strategy in acute respiratory distress~     syndrome (ARDS) patients. Nevertheless, it is well known that esophageal balloon catheter~     derived parameters can be influenced by several patient-related or technical-related factors.~      During a PEEP trial, the investigators will observe in-vivo the esophageal pressure and~     derived measurements obtained using different esophageal balloon calibration volumes.~   "
47443|NCT02945904|"~     Purpose of this clinical trial is to improve prediction of outcomes from surgical~     intervention in patients with Primary aldosteronism, and evaluate the merits of non-invasive~     metomidate PET CT versus adrenal vein sampling in the diagnosis of surgically correctable~     aldosteronism.~   "
47444|NCT02945891|"~     Study aims to support development of evidence based health care in Norway through evaluating~     recently proposed technological improvements in cervical cancer control before their routine~     use. SESAM II study evaluates the accuracy of vaginal self-sampling for high risk human~     papillomavirus (hrHPV) testing compared with a physician-taken sample.~   "
47446|NCT02945865|"~     It is estimated that 45-80 % of nursing home residents have substantial pain at any given~     time. Residents with impaired cognition have been found to report chronic pain more often,~     more frequent and more severe, compared to residents with normal cognition. Approximately 3/4~     of permanent residents in nursing homes in Norway have developed dementia. The burden of~     dementia is often compounded by painful conditions. Despite over a decade of research on the~     subject, inadequate pain assessment and management remain significant problems among~     institutionalized older adults, with and without dementia. The poor pain management in~     patients with dementia has been attributed, at least in part, to difficulties with, and lack~     of, pain assessment in this population. Therefore, this study seek to determine the effect of~     regular pain assessment.~   "
47447|NCT02945852|"~     Although fist-line therapy with Cisplatin and etoposide(EP)or Carboplatin and~     etoposide(CE)and second-line therapy with topotecan has been given, patients with extensive~     small cell lung cancer(ED-SCLC) still relapse and 2-year survival is less than 10%. There is~     no standard treatment recommendation for this group of patients who failed to second-line~     therapy and had good performance status. Apatinib has been approved as a second-line~     treatment for advanced gastric cancer. Several phase III clinical studies of non small cell~     lung cancer, liver cancer, colorectal cancer and other tumors also showed apatinib has less~     toxic side effects and better patient tolerance. However, the clinical application of~     apatinib in small cell lung cancer is still lack of evidence-based medicine. And this~     clinical trial is designed to prospectively investigate the efficacy and safety of apatinib~     in refractory or recurrent ED-SCLC patients in our center.~   "
47448|NCT02945839|"~     Collectively, evidence shows that a combination of medication and behavioral therapy is most~     effective for migraine care. The ED is a critical point of contact with the health care~     system for many migraine patients; in current practice, it is a missed opportunity to~     initiate and establish a comprehensive migraine management paradigm. Behavioral headache~     treatments (e.g., progressive muscle relaxation (PMR), biofeedback, cognitive-behavioral~     therapy (CBT)) are effective migraine treatment options that are essentially free of side~     effects. PMR has also been successful as a technique that patients can do independently.~     Studies have shown that combination pharmacological-behavioral therapy is most effective for~     migraine treatment.~      Several aspects of this study are innovative, including: 1. Initiation of preventive~     medication in a timely manner for migraineurs who present to the ED. 2. Introduction of~     PM+PMR in the ED at a time that can serve as a teachable moment. 3. Introduction of a~     smartphone application-based product (a minimal contact based behavioral therapy) in the ED~     setting to reduce headache disability, frequency, and intensity.~   "
47449|NCT02945826|"~     The purpose of this study is to investigate the applicability of urokinase plasminogen~     activator receptor (uPAR) Positron Emission Tomography (PET) / MRI molecular imaging of~     glioblastoma.~   "
47450|NCT02945813|"~     The main objective of the trial is to explore the efficacy of salvage radiotherapy (SRT) plus~     metformin compared to SRT in the endpoint of time to progression after prostatectomy failure.~   "
47451|NCT02945800|"~     The purpose of this study is to see if nab-paclitaxel combined with gemcitabine prevents the~     formation or growth of tumors in participants with relapsed or refractory osteosarcoma, Ewing~     sarcoma, rhabdomyosarcoma and other soft tissue sarcoma and to measure the length of time~     during and after treatment that their disease does not get worse. Researchers also want to~     find out if nab-paclitaxel combined with gemcitabine is safe and tolerable.~   "
47452|NCT02945787|"~     Results of a recently completed National Cancer Institute (NCI) funded trial of an~     intervention, Forever Free: Stop Smoking for Good, revealed high efficacy throughout the 24-~     month follow-up period, further supporting the utility of extended self-help for promoting~     and maintaining tobacco abstinence. Investigators have recognized that wide-scale~     implementation, and therefore public health impact, would be enhanced by the availability of~     a Spanish-language version to reach the largest and fastest growing ethnic minority~     population of smokers.~      The goal of this study is to address this gap by testing a Spanish-language version of the~     validated self-help smoking cessation intervention. If demonstrated effective, the proposed~     intervention would represent an easily disseminable and low-cost intervention with~     significant public health impact for Hispanic/Latino smokers throughout the United States.~     The aims of this project are to test the efficacy of a Spanish-language version of a~     validated, extended self-help intervention for smoking cessation among Spanish-speaking~     smokers against usual care control. Participants (N = 1400) recruited nationally will be~     randomized to the two arms.~   "
47453|NCT02945774|"~     Neuroinflammation is increasingly implicated as a potential critical pathogenic mechanism in~     a variety of neurologic and psychiatric disorders. This study will use hybrid PET/MRI imaging~     to evaluate neuroinflammation and its relationship to cerebral perfusion in frontotemporal~     dementia (FTD). Patients with FTD will be recruited from the Cognitive Neurology and Aging~     Brain clinics at Parkwood Institute and will undergo neurocognitive assessment and MRI/PET~     using the PET ligand FEPPA which binds to activated microglia, a marker of neuroinflammation.~     Correlations will be conducted to determine whether abnormal neuroinflammation is present in~     Frontotemporal dementia and whether differential patterns of neuroinflammation are present in~     different FTD clinical and molecular subtypes, and to determine the relationship between~     neuroinflammation, cerebral perfusion using arterial spin labeling MRI imaging techniques,~     and indices of brain structure including volumetric and white matter analysis.~   "
47475|NCT02945488|"~     The objectives are to: 1) Assess the independent and synergistic efficacy of exercise and~     nutrition interventions to manage major symptomatic concerns of inflammatory bowel diseases~     (IBD), 2) Assess the independent and synergistic efficacy of exercise and nutrition to~     mitigate inflammation in IBD, and 3) Assess the feasibility of such an intervention in~     preconception women with IBD. The investigators hypothesize that the combination of~     anti-inflammatory exercise and nutritional interventions will have a synergistic effect on~     managing major symptomatic concerns associated with IBD, reducing inflammation, and improving~     fertility status in preconception women with IBD, as compared to either intervention~     independently.~   "
47476|NCT02945475|"~     This study is aimed at understanding neuroendocrine responses to different types of sugars~     and how this influences feeding behavior among lean, obese and obesity prone individuals.~   "
47477|NCT02945462|"~     Recovery of erectile function using bone marrow mesenchymal stem cells (MSCs) after in vitro~     expansion under restricted culturing conditions.~   "
47454|NCT02945761|"~     Surgeons easily get wound infections. Most wound infections will be cured by applying~     medicines and changing dressing in very short period of time. But some wounds are severely~     contaminated combined with fat liquefaction, crateriform ulcer and large undermined lacuna,~     so changing dressing takes a very long time. In order to better change the dressing, it needs~     to expose the wound thoroughly, which requires to completely open the healed skin, so the~     healing will be slowed down. Some scholars lay stress on prevention. Wound infection control~     concerns prevention--not therapy--of an infrequent but expensive kind of surgical~     morbidity.(1.2)Some scholars think that the main armamentarium of the attack is the use of~     topical anti-infectives, which invade the bacteria where they reside, and, consequently,~     reduce their numbers and promote wound healing.(3)For example, silver is reemerging as a~     viable treatment option for infections encountered in burns, open wounds, and chronic ulcers.~     But it is expensive and is difficult to acquire silver-containing dressings. And Recent~     findings, however, indicate that the compound delays the wound-healing process and that~     silver may have serious cytotoxic activity on various host cells. (4) As High concentration~     of sugar solution, honey appears to heal partial thickness burns more quickly than~     conventional treatment (which included polyurethane film, paraffin gauze,~     soframycin-impregnated gauze, sterile linen and leaving the burns exposed) and infected~     post-operative wounds more quickly than antiseptics and gauze.(5)This study involve the use~     of another high-concentration of sugar solution (HCSS) to lavage infected wounds when~     changing dressings.~   "
47455|NCT02945748|"~     Hemodynamically unstable ventilated PICU & PCICU patients, which a decision for commencement~     in inotropic therapy or fluid bolus has been made, will be recruited. Hemodynamic~     measurements will be carried out before and after therapy have been made, including customary~     hemodynamic parameters, echocardiography and USCOM studies.~      All parameters will be analyzed for fluid responsiveness or inotropic therapy prediction.~     Trend in USCOM parameters will be compared to echocardiography CO parameters.~   "
47456|NCT02945735|"~     The purpose of this study is to determine whether giving gaze-contingent feedback is an~     effective attention modification procedure, helping in the treatment of Major Depressive~     Disorder (MDD)~   "
47457|NCT02945722|"~     S. aureus nasal carriage is a well-known risk factor for S. aureus infections in hemodialysis~     (HD) patients. Strains of carriage and infections are the same in >80% of cases We recently~     shown that persistent carriers of S. aureus, not intermittent ones are at increased risk of~     staphylococcal infections in HD. Thanks to a new algorithm developped based on one nasal~     sample the determination of carriage status (persistent, intermittent or non-carriers) among~     patients is easy. Mupirocin use in HD have been shown to reduce significantly S. aureus~     infections however, multiples schedules of decolonization have been proposed to all S. aureus~     carriers. To date, there is no national guideline for decolonization of S. aureus in HD. We~     showed that only 50% of HD centers in France propose screening and decolonization of S.~     aureus carriers. The aim of the study is therefore to evaluate the impact of a targeted~     decolonization of S. aureus persistent carriers using mupirocin nasal ointment and~     chlorhexidine baths during 5 days on the occurrence of S. aureus infections in HD patients~     compared to the absence of decolonization using a randomized open study methodology.~   "
47458|NCT02945709|"~     The purpose of this study is to explore the efficacy of Attention Control Training for Post~     Traumatic Stress Disorder (PTSD).~      ACT was found to be effective in decreasing attention bias variability and PTSD symptoms in~     combat veterans (Badura-Brack, et al., 2015). It is now important to continue the examination~     of ACT's efficacy in additional populations of patients with PTSD. Such extension of~     treatment to other traumatic experiences raises the question of whether the threatening~     content of the training material could be personalized for each patient.~   "
47459|NCT02945696|"~     The investigators will perform a prospective randomized study to compare the effectiveness of~     laparoscopic-guided abdominal wall nerve blocks with local wound site infiltration and with~     ultrasounded guided abdominal wall blocks.~   "
47460|NCT02945683|"~     The purpose of this study is to evaluate in a randomized, double-blinded, controlled trial,~     whether a new food supplement containing Lactobacillus reuteri DSM 17938 and vitamin D3~     (Reuterin® D3) may improve the SCORAD in pediatric patients with mild to moderate atopic~     dermatitis~   "
47461|NCT02945670|"~     The purpose of this study is to learn what women of childbearing age think of Long Acting~     Reversible Contraception. A variety of myths regarding LARCs have been described in the~     literature. This study is designed to asses women's cultural belief's regarding LARCs.~     Investigators are looking to collect information from women in general, rather than solely~     who are seeking contraception. Investigators will be recruiting women ages 18-45 years from~     seven family health centers affiliated with UPMC. Participants will be asked to a attend a~     60-90 minutes focus group session. During the session the facilitator will try to engage~     participants in a discussion about contraception in general. They will also be asked to~     complete a short demographic survey of 8-12 questions. Data from focus groups will be~     assessed for recurring themes which will be used to create a cultural survey instrument that~     will be used in the second phase of the study.~   "
47462|NCT02945657|"~     The purpose of this study is to assess the pharmacokinetic parameters and safety of topical~     MM36 (OPA-15406) ointment in pediatric subjects with atopic dermatitis under maximal use~     conditions.~   "
47463|NCT02945644|"~     Trazodone may help obstructive sleep apnea patients to stick to their therapy, but optimal~     dosing is unknown. This study looks at what dose of trazodone has the best balance of~     potential benefits to side-effects in people with obstructive sleep apnea who are either~     starting on positive airway pressure therapy or not adherent to it. Participants will be~     randomly assigned to one of three groups: trazodone 50 mg, trazodone 100 mg, or placebo for~     14 days. The investigators will monitor side-effects and adherence to positive airway~     pressure therapy.~   "
47464|NCT02945631|"~     The purpose of this study is to establish the efficacy and toxicity of low dose~     chemoradiotherapy after induction chemotherapy in patients with locally advanced HPV+~     oropharynx cancer and establish prognostic factors that would apply to help select patients~     for this treatment in the future.~   "
47478|NCT02945449|"~     Intracavernous injection of Wharton jelly Mesenchymal stem cells for the treatment of~     erectile dysfunction in diabetic patients.~   "
47465|NCT02945618|"~     The objective of this exploratory randomized control trial is to compare, in participants~     with acute lateral ankle sprain (LAS) , the reduction of symptoms and functional limitations~     between two groups of subjects who undergo a conventional rehabilitation program with~     (experimental group) or without CRYOFOS (comparison group). The hypothesis is that CRYOFOS~     will lead to a faster reduction of symptoms and functional limitations, and a faster return~     to daily living activities.Thirty-six participants of 18 years of age and older with acute~     LAS (sustained a LAS three days or less before the first evaluation session) will be~     recruited and randomly assigned to either a group receiving conventional rehabilitation~     program with the addition of CRYOFOS (experimental group; n=18), or to a group only receiving~     the conventional rehabilitation program (comparison group; n=18). This single-blind~     (evaluator), parallel-group RCT will include five evaluation sessions over 6 weeks (baseline,~     day 7, week 2, week 4 and week 6) and 8 treatment sessions (1st and 2nd weeks: 3~     sessions/week; 3rd and 4th weeks: 1 session/week) during a 4-week period. The primary outcome~     will be the functional limitations, evaluated using the Lower Extremity Functional Scale~     (LEFS).~   "
47466|NCT02945605|"~     This study examines the effect of early vestibular rehabilitation on reducing physical~     post-concussion symptoms (e.g. dizziness, balance problems) and improving the timeline to~     achieve medical clearance to return to activities such as sports and work activities. Half of~     the participants will receive early vestibular rehabilitation added to standard of care,~     while the other half will receive standard of care only.~   "
47467|NCT02945592|"~     The presented study investigates standardized visual cueing in reading and visual spatial~     task as a treatment method for spatial neglect. In a randomized controlled design patients~     receive either cued reading and visual spatial tasks (intervention) or treatment which is~     unspecific to neglect (control).~      In the intervention condition, patients with left-sided neglect receive intense training,~     including reading and visual spatial task with standardized and adapted visual cueing by the~     therapist. Improvements in reading and visual spatial tasks lead to a reduction of cues by~     the therapist. Accordingly, the patient has to apply self-cueing over time in order to solve~     the task.~      For the control condition, all patients receive unspecific treatment without any standardized~     adapted cueing implemented by the therapist.~      To enhance the effectivity of cueing in reading and visual spatial tasks, the investigators~     additionally conduct parietal transcranial direct current stimulation (tDCS) in those~     patients without tDCS exclusion criteria (see exclusion criteria below).~      It is hypothesised that systematic and adaptive therapeutic cueing leads to a significant~     reduction of omissions of word and word parts in reading.~      UPDATE: No Add-on tDCS was performed since it was not applicable for our severly impaired~     patients due to the strict exclusion criteria of tDCS.~   "
47468|NCT02945579|"~     The goal of this clinical research study is to learn how often breast cancer recurs (returns~     after treatment) in the breast in patients who have been treated with chemotherapy and have~     had follow-up radiation therapy (but not surgery) and are in complete remission (no evidence~     of disease).~      This is an investigational study. Radiation therapy is delivered using FDA-approved and~     commercially available methods. The study doctor can explain how radiation therapy is~     designed to work.~      About 50 participants will be enrolled on this multicenter study. Up to 50 may take part at~     MD Anderson.~   "
47469|NCT02945566|"~     Colorectal cancer is the third most common tumour in the UK, Netherlands and Denmark with~     41000, 14000 and 4000 new cases per year respectively. Standard primary radical Total~     Mesorectal Excision (TME) surgery is an oncologically effective treatment for early stage~     rectal cancer. However, resection of a low rectal tumour requires a permanent stoma in~     approximately 5-10% of cases while many more patients have a temporary stoma, some of which~     are not reversed. Radical surgery, which evolved to treat locally advanced, symptomatic~     tumours, may not be the optimal method of treatment for early screen-detected tumours and an~     organ preserving strategy may generate significantly less morbidity without substantially~     compromising oncological outcomes.~      TREC was a randomised phase II trial to test the feasibility of randomisation between TME and~     an organ preserving policy of short course pre-operative radiotherapy (SCPRT) delay followed~     by transanal endoscopic microsurgery (TEM). STAR-TREC is a phase II feasibility study that~     will evaluate whether it is possible to accelerate the patient recruitment attained in the~     TREC study, to 4 per month in the first year of recruitment and 6 per month in the second.~     This would demonstrate deliverability of a phase III study.~   "
47470|NCT02945553|"~     Traumatic knee injury is common and highly debilitating. Surgical reconstruction/repair~     improves knee biomechanics and function, but neuromuscular dysfunction persist for years~     despite rehabilitation, hindering resumption of normal activities, increasing risk of further~     injury and, in a majority of patients, hastening the development of knee osteoarthritis (OA).~     Our goal in this research study is to evaluate the utility of neuromuscular electrical~     stimulation (NMES), initiated following injury and maintained through the early post-surgical~     period, to prevent muscle atrophy and intrinsic contractile dysfunction compared to active~     control intervention of micro-electrical stimulation.~   "
47471|NCT02945540|"~     This study seeks to evaluate patient satisfaction within the patient therapeutic education~     program gestational diabetes (multidisciplinary and multi-professional program) to see if~     they deem effective to limit the impact of gestational diabetes on pregnancy . Patients are~     questioned on the skills acquired in everyday life, the effective support in personal~     development, development of self-determination capabilities and communication with health~     professionals.~      This study must include all patients participating in the therapeutic education program for a~     year and meeting the inclusion criteria.~   "
47472|NCT02945527|"~     Three-arm open, randomized comparative study of acetazolamide, dexamethasone, or no~     additional treatment to evaluate decrease in peri-calcification edema in neurocysticercosis~   "
47473|NCT02945514|"~     Provide personally tailored dietary suggestions to participants based on the Personalized~     Prediction Engine (patent pending) owned by DayTwo.~   "
47474|NCT02945501|"~     The purpose of this study is to determine if the enhancement of electroencephalographic (EEG)~     slow-wave activity using transcranial electrical stimulation (TES) at Slow Oscillation (SO)~     frequency, during a restricted period of nocturnal sleep, enhances the restorative properties~     of that period of sleep and improves performance during a subsequent period of sleep~     deprivation.~   "
47479|NCT02945436|"~     A sample of 600 young (15-29) men who have sex with men (MSM) and transgender persons living~     in South-East Michigan's Detroit Metro Area (DMA) will be recruited through venue-based~     sampling and online ads to examine the efficacy of adding a substance use brief intervention~     (SUBI) to standard HIV prevention and care (SOC) for achieving gains in successful engagement~     in HIV care. The investigators will partner with Detroit-area AIDS Service Organizations~     (ASOs) to deliver the intervention.~   "
47480|NCT02945423|"~     Catatonia is a neuropsychiatric syndrome which is frequently missed or misdiagnosed among~     psychiatric patients. The current project is a systematic examination of catatonia which will~     characterize the phenotype and identify biological correlates that play a central role in the~     pathophysiology and effective pharmacological treatment of this condition.~   "
47481|NCT02945410|"~     The purpose of this study is to determine if an increased protein intake can attenuate the~     suppression of metabolic and anabolic hormones during caloric restriction~   "
47482|NCT02945397|"~     The study compares the effect of a group-based activity with an individual work-out activity~     on work participation.~   "
47483|NCT02945384|"~     This project involves the development of a scaled-up model of a successful dual-generation~     intervention targeting attention, stress, and self-regulation in families attending Head~     Start, and improvements of outcome assessments of the intervention. The investigators~     hypothesize that families randomly assigned to receive the intervention, compared to families~     not receiving the intervention, will show improved brain function for attention and~     self-regulation and improved physiological function for stress regulation in both children~     and their parents, improvements in child school performance and cognition, and improvements~     in assessments of parent/family well being.~   "
47484|NCT02945371|"~     Insufficient inhibitory control is one pathway through which early adversity is related to a~     range of problems including excessive alcohol use, tobacco use, and unhealthy eating. The~     proposed research leverages a neurally informed model of inhibitory control and how it can be~     improved to test the efficacy of a person-centered inhibitory control intervention in a~     sample of mid-life individuals with early adversity. The knowledge obtained by this study~     could be scaled into a flexible, low-cost, and wide-ranging intervention to remediate some of~     the effects of early adversity on inhibitory control and thus a number of prevalent health~     risking behaviors.~   "
47485|NCT02945358|"~     A prolonged stay in intensive care unit (ICU) after cardiac surgery with cardiopulmonary~     bypass increases not only cost of patient care but also morbidity and mortality of patients.~     The ability to predict which patient has the tendency to have a prolonged ICU stay would help~     in patient and resource management of the hospital. There are many predictive models aiming~     at identifying patient at risk of prolonged ICU stay after cardiac surgery with~     cardiopulmonary bypass but almost all involve the preoperative assessment for proper resource~     management with one model, Open-Heart Intraoperative Risk (OHIR) Scoring concerning~     intraoperative manipulatable risk factors to improve anesthetic care and patient outcome. The~     OHIR model comprises 6 risk factors, 5 of which can be managed intraoperatively, with total~     score of 7 and a score of ≥ 3 indicating a likely prolonged ICU stay. The objective of this~     study was to re-validate the performance of OHIR score in the recent context.~   "
47486|NCT02945345|"~     The Evaluation of Clinical Responsiveness Using the Cutaneous Dermatomyositis Disease Area~     and Severity Index (CDASI), established in 2008, is a one-site database study conducted at~     the University of Pennsylvania. The database has yielded valuable information and clinical~     insights into the pathophysiology, disease processes, including psychological responses,~     treatments and quality of life associated with dermatomyositis. The CDASI database~     incorporates the Cutaneous Dermatomyositis Disease Area and Severity Index), a validated~     outcome measure of disease responsiveness in patients, and other assessment tools, surveys~     and patient information to help validate the clinical course and quality of life of patients~     with dermatomyositis.~      The CDASI database has led to publication of comparison studies of CDASI and other clinical~     instruments and the effect of dermatomyositis on Quality of Life (QoL).~      The CDASI database is an ongoing resource that enables clinicians to evaluate the evolving~     clinical changes, treatment modalities and patient response to a challenging disease. Data~     will be analysed over a 5 years.~   "
47487|NCT02945332|"~     Specifically, the main objective of this pilot and feasibility study is to develop the~     infrastructure that will be used in a larger study that would be proposed at a later date.~     Hence, this study has two parts. Part A: To establish contacts, collaboration, and networking~     to develop the infrastructure needed to conduct the study, Part B: To recruit eight subjects~     (4 subjects randomly assigned to either a control group or intervention group) from a~     low-income community in East Lubbock who are willing and able to participate in this pilot~     study. The research team's central hypothesis is that the disease burden of obesity and~     related co-morbidities could be attenuated within low-income communities by providing~     incentive-based free access to a safe and convenient exercise facility and earned credit to~     subsidize healthful food cost. The research team's secondary hypothesis is that the~     anticipated decrease in disease burden will make the incentivized changes in lifestyle~     cost-effective.~   "
47494|NCT02945241|"~     Determine if a cystatin C-inclusive vancomycin dosing algorithm improved target trough~     achievement compared to creatinine clearance-guided vancomycin therapy in critically ill~     patients.~   "
47495|NCT02945228|"~     The main objective of this study is to evaluate the safety and effectiveness of~     paritaprevir/ritonavir/ombitasvir with ribavirin used for participants infected with chronic~     hepatitis C virus (HCV) genotype 2 in daily practice in Japan.~   "
47496|NCT02945215|"~     Randomised, double-blind, parallel group study to compare PK and PD profiles between IBI301~     and rituximab in patients with CD20+ B-cell Lymphoma~   "
47497|NCT02945202|"~     This study investigates the effects of trabeculectomy and combined phacoemulsification plus~     trabeculectomy on corneal astigmatism.~   "
47498|NCT02945189|"~     This is a sample collection study, participants will be required to collect one (if last~     menstrual period ≥12 months) or two (if last menstrual period <12 months) urine samples and~     return them to the study site, together with collection sample information. Participants~     having a menstrual cycle within the last 6 months will also be required to provide follow-up~     information on pregnancy status and date of next menstrual bleed.~   "
47488|NCT02945319|"~     The study aims at developing and validating an integrated clinico-molecular model for an~     accurate survival prognostication in newly diagnosed SMZL.~      Already existing and coded tumor biological material and health-related personal data will be~     retrospectively collected. Mutation analysis will be performed by targeted deep next~     generation sequencing of tumor genomic DNA. Deletion of 7q will be assessed by FISH on nuclei~     isolated from tumor tissues. Immunoglobulin gene rearrangement and mutation status will be~     analyzed on tumor genomic DNA by PCR and Sanger sequencing. The methylation status of target~     genes will be assessed by methylation specific PCR on tumor genomic DNA.~      The adjusted association between exposure variables and OS will be estimated by Cox~     regression. This approach will provide the covariates independently associated with OS that~     will be utilized in the development of a hierarchical molecular model to predict OS. The~     hierarchical order of relevance in predicting OS among covariates will be established by~     recursive partitioning analysis. An amalgamation algorithm will be used to merge terminal~     nodes showing homogenous OS. The discrimination capacity of the model will be assessed by~     calculating the c-index. Relative survival analysis will be used to provide a measure of the~     excess mortality experienced by patient's subgroups stratified according to the developed~     hierarchical molecular models, irrespective of whether the excess mortality is directly or~     indirectly attributable to the disease. The model developed in the training set will be~     tested in the validation sets and the model performance (c-index) in the validation set will~     be compared with that in the training set.~   "
47489|NCT02945306|"~     Sleep disorder breathing (SDB) is a condition affecting 10% of children aged 2-6 years. It is~     a combination of snoring most nights during sleep, patchy sleep, short periods of stopping~     breathing (apnoea) and usually big tonsils. Most of these children get better with no~     treatment by 8 years old. It has been suggested that having SDB mean that some children~     concentrate and behave less well during the day and may learn more slowly than children who~     don't snore. It has become common for many Ear, Nose and Throat (ENT) surgeons to take out~     tonsils and adenoids (adenotonsillectomy) for this condition. Removing the tonsils and~     adenoids (which are normally big at this age) means that most children quickly stop snoring~     and seem to be cured. Unfortunately it is not clear if this operation makes any difference to~     learning compared to just watching the child and letting them grow out of the condition~     (watchful waiting).~      There is no set treatment in the UK today. Children may be offered adenotonsillectomy or~     watchful waiting; it is not know which, long term, is the right thing to do. Therefore the~     investigators wish to do a study looking at these two different treatments to see if there is~     a difference in children's learning over time between the two different treatments. The~     investigators will look at children with SDB, measure their learning (and behaviour) and then~     randomly select which children get one treatment or the other. They will then re-measure~     learning (and behaviour) 7 months later to see if there is any difference between the two~     groups. The investigators will also scientifically measure their sleep. This is possibly~     quite a difficult study to do, the investigators are unsure whether families will agree to~     take part and how easy it will be to measure learning with such young children (aged 2:6 -~     5).~   "
47490|NCT02945293|"~     The purpose of this study is to examine the relationship between heavy alcohol use, pain, and~     response to pain medication in older adults.~   "
47491|NCT02945280|"~     This study will assess the safety and effectiveness of a drug called apixaban for the~     treatment of upper extremity deep vein thrombosis (UEDVT) and clinically important bleeding.~     Subjects will receive apixaban 10 mg by mouth twice a day for 7 days, followed by 5 mg by~     mouth twice a day for a duration of 11 weeks. There will be a followup visit at 12 weeks for~     all participants. A total of 375 are to be enrolled.~      The study drug has been approved to treat blood clots. The study drug has not been studied~     uniquely for the treatment of blood clots in the upper extremity however. Because it is~     unknown whether it is effective to treat blood clots in the upper extremity, the principal~     investigator cannot guarantee that there will be benefit to study subjects; however, it is~     hoped that the information obtained from this research study will help treat patients in the~     future.~   "
47492|NCT02945267|"~     Background: Monotherapy with S-1, oral fluoropyrimidine, shows non-inferiority to gemcitabine~     in overall survival (OS) with good tolerability for advanced pancreatic cancer in Asian~     patients. It is also shown that nimotuzumab plus gemcitabine could improve OS and progression~     free survival (PFS) in patients with unresectable pancreatic cancer. However, it is still~     unknown whether nimotuzumab plus S1 would improve more to OS and PFS than single S-1.~     Maintenance treatment, as a new treatment pattern, has also been tried in these patients~     after first line treatment to improve the OS. Thus, this study is designed to compare~     nimotuzumab plus S1 to placebo plus S1 as maintenance treatment in patients with locally~     advanced or metastatic pancreatic cancer who has benefited from the first-line treatment of~     gemcitabine combined with nimotuzumab and S1 (complete response+partial response+stable~     disease).~      Patients and methods: 60 patients will be enrolled,and randomized in a 1:1 ratio to group~     nimotuzumab plus S1 and group placebo plus S1. nimotuzumab/placebo: 400 mg/w, intravenous~     infusion, Infusion time ≥ 60 min, d1, once every two weeks. S1: oral, 40 mg (Body surface~     area<1.5 m2) or 60 mg (Body surface area>1.5 m2), d1-d14, every three weeks for a cycle.~     Treatment interventions will be stopped under the conditions of disease progression or~     intolerable toxic reaction or participants ask to quit. The primary endpoint is the time to~     disease progression since randomization (TTP), secondary points include OS, 3 years overall~     survival rate (OSR) and safety.~   "
47493|NCT02945254|"~     Insufficient and low-quality sleep is a major public health problem that has been linked to~     motor vehicle crashes, industrial disasters, and medical and other occupational errors.~     Persons experiencing sleep insufficiency are also more likely to suffer from chronic diseases~     such as hypertension, diabetes, depression, and obesity, as well as from cancer, increased~     mortality, and reduced quality of life and productivity.~      The number of people using sleep-inducing drugs to increase or improve sleep is steadily~     increasing in the last few decades; however, the side effects of these therapies often~     outweigh the benefits.~      A few small trials and anecdotal findings suggest that continuous background (pink or white)~     noise overnight can improve sleep quality, increase acoustic arousal threshold, and reduce~     sleep onset latency.~      In an attempt to find new, alternative solutions to increase sleep quality in people~     suffering from insomnia, the investigators would like to test the effect of surrounding~     filtered white noise on sleep onset latency and subjective sleep quality in healthy subjects.~   "
47499|NCT02945176|"~     The ARGOS-IO pressure sensor is intended to be implanted in the human eye in combination with~     Boston Keratoprosthesis (BKPro) surgery and to remain in place indefinitely. It is intended~     to be used together with the hand-held Mesograph reading device to telemetrically measure the~     intraocular pressure (IOP) of patients with a BKPro.~      The purpose of this study is to evaluate the safety and performance of the ARGOS-IO system in~     patients undergoing concomitant implantation of a BKPro and an ARGOS-IO sensor over the 12~     month period beginning at implantation.~   "
47500|NCT02945163|"~     Tenofovir+lamivudine+efavirenz is still the first line regimen of combination antiretroviral~     therapy in developing countries. Based on our previous data, we aim to evaluate whether~     reduce the dose of tenofovir and efavirenz could decreasing the incidence of the side effects~     while not scarifying their virological efficacy.~   "
47501|NCT02945150|"~     Proof of concept, open-label single center study for the donation of HCV positive kidneys to~     HCV negative patients, with preemptive, interventional treatment to prevent HCV transmission~     upon transplantation.~   "
47502|NCT02945137|"~     The accurate diagnosis of H. pylori infection is an important step for establishing the~     strategy for gastric cancer prevention. During endoscopy, rapid urease test (RUT) is the~     first of biopsy-based H. pylori tests. Despite indirect test for H. pylori detection, RUT~     shows rapid result with good sensitivity and specificity. Several study reported that H.~     pylori density was related to positive reaction time of RUT. However, there was no study~     comparing the positive reaction times of RUT according to biopsy site, degree of gastric~     atrophy, and intestinal metaplasia.~   "
47503|NCT02945124|"~     To investigate the effects of K Tape on walking pattern, muscle activity and motor~     performance in children with and without developmental coordination disorder (DCD).~   "
47504|NCT02945111|"~     The purpose of this study is to assess whether the degree of anxiety experienced by women~     undergoing visual inspection with acetic acid (VIA) and Lugol's iodine (VILI) can be reduced~     by watching the procedure in real-time on a digital screen.~   "
47505|NCT02945098|"~     Sixty volunteers with a mean age of 21,8 ± 2,6 years participated in this study, randomly~     distributed into one of the following groups: control, Kinesio taping group with tension in~     the anterior arm region and Kinesio taping group without tension in the same region. All~     subjects underwent an eccentric exercise protocol and three evaluations: before the protocol,~     immediately after and 48h after protocol. The following variables were analyzed: sensation of~     pain as the primary outcome; peak torque normalized by body weight; average peak torque;~     total work and average power, using an isokinetic dynamometer. In addition, muscle activation~     amplitude (Root Mean Square) and median frequency were recorded using surface~     electromyography.~   "
47506|NCT02945085|"~     This study addresses how to achieve better outcomes for cognitively vulnerable~     community-dwelling older adults and their families. Cognitive vulnerability means living with~     dementia, depression, and/or a recent episode of delirium (the 3Ds). The investigators will~     test the effectiveness of a team care model focused on the 3Ds (Home Based Care Team) guided~     by nurse practitioners with expertise in geriatrics and geriatric psychiatry. Specific aims~     are to determine Home Based Care Team effects on hospitalization or emergency department use,~     and other outcomes including depression, disability, and quality of life.~   "
47507|NCT02945072|"~     The aim of this study is to investigate long-lasting or later behavioral changes in children~     in the context of different anesthesia techniques (Inhalation anesthesia vs. TIVA)~   "
47508|NCT02945059|"~     The aim of this study is to prospectively evaluate the tolerance and efficiency of a new~     technique of preoperative selective portal vein embolization (PVE) in patients requiring~     major hepatic resection.~   "
47509|NCT02945046|"~     This is a 13-week, multicenter, randomized, double-blind, double-dummy, placebo-controlled,~     parallel-group study to compare the efficacy and safety of 2 dose regimens of TEV-48125~     (Fremanezumab) versus placebo in adult patients for the prevention of ECH.~   "
47510|NCT02945033|"~     Four retrospective studies were recently published on efficacy of aspirin in patients with~     surgically resected colon cancer. Two of these studies strongly suggested that aspirin used~     in low doses (100 mg/d) after surgical resection of colorectal cancer with PI3K mutation~     could act as a targeted therapy with a major protective effect on the risk of recurrence. The~     other two studies did not confirm the benefit of aspirin in this situation. These four~     retrospective studies provide an insufficient level of evidence to demonstrate the benefit of~     low-dose aspirin as adjuvant to surgery for colorectal cancer. Therefore, it is necessary as~     recommended in the conclusion of these studies and meta-analyses to perform a randomised~     prospective study to validate these data.~   "
47511|NCT02945020|"~     The purpose of this study is to evaluate the effect of steady-state concentrations of~     odalasvir (ODV), as a single agent or in combination with simeprevir (SMV), on the~     single-dose pharmacokinetics of dabigatran etexilate in healthy participants.~   "
47512|NCT02945007|"~     The purpose of this study is to assess the relative bioavailability of 1 to 3 concept~     formulations of JNJ-53718678 compared to the currently existing oral solution, and to assess~     the effect of food on the bioavailability of 1 to 3 oral concept formulations of JNJ-53718678~     when administered as a single oral dose of 500 milligram (mg) in healthy adult participants.~   "
47513|NCT02944994|"~     The purpose of this study is to examine effectiveness and implementation for the Unified~     Protocol for the Transdiagnostic Treatment of Emotional Disorders in trauma exposed veterans.~   "
47514|NCT02944981|"~     The intrathecal administration of morphine is gaining popularity. It is easy to do and can~     reduce the pain after surgery up to 24 hours. However, it causes postoperative nausea and~     vomiting more than other methods providing postoperative analgesia. Patients suffering from~     these side effects have to spend a longer period of time recovering in the hospital with high~     cost of medical treatment.~   "
47515|NCT02944968|"~     The QDOT-Micro study is a prospective, multi-center, non-randomized, interventional clinical~     study.~   "
47516|NCT02944955|"~     This is a clinical trial to determine the safety, recommended dose level (RDL), and infection~     control of BLEX 404 Oral Liquid in combination with azacitidine in patients with~     International Prognostic Scoring System (IPSS) intermediate-1 (int-1), intermediate-2 (int-2)~     or high-risk myelodysplastic syndrome (MDS) and Chronic Myelomonocytic Leukemia (CMML).~   "
47517|NCT02944942|"~     General anesthetic technique plays a key role in most surgical procedures. This technique has~     some complications especially postoperative nausea/vomiting (PONV). This complication can~     lead to serious problems. Department of Anesthesiology has developed and implemented a PONV~     prophylaxis guideline for high risk PONV patients but PONV still remains.~   "
47518|NCT02944929|"~     The addition of a self-rehabilitation program to repeated Botulinum Toxin Injections (BTI)~     and usual physiotherapy should increase the proportion of patients who attain their Primary~     Treatment Goal (impairments and function) more than usual care (involving repeated Botulinum~     Toxin Injections and conventional physiotherapy), in post stroke out-patients with~     spasticity.~   "
47519|NCT02944916|"~     The study descripted of efficacy of IryPump®R Set in term of success of the procedure at each~     irrigation~   "
47520|NCT02944903|"~     The investigators will conduct nationally representative survey in chest physicians in Egypt~     in 2016-2017. Self-administered questionnaire will be used to assess the physicians'~     knowledge of lung cancer screening guidelines, beliefs about the effectiveness of screening~     tests, and ordering of screening chest radiography, low-dose spiral computed tomography, or~     sputum cytology in the past 12 months.~   "
47521|NCT02944890|"~     The purpose of this study is to evaluate the safety and efficacy of Paclitaxel drug eluting~     balloons (RESTORE DEB, 3μg/mm2 balloon surface area ) for success of intervention treatment~     and maintaining the vessels unobstructed in the treatment of coronary in-stent restenosis~     compared with a product of the same category (SeQuent® Please).~   "
47522|NCT02944877|"~     This study [HOPE: Harnessing Online Peer Education] seeks to determine the efficacy of using~     online social networks to scale peer community leader models to increase HIV prevention~     within African-American and Latino men who have sex with men. The peer community leader~     model, which teaches community popular opinion leaders about how to disseminate behavior~     changes messages throughout the community, has been proven to increase HIV prevention~     behaviors. Social networks such as Facebook.com may be a cost-effective platform for scaling~     these models. Primarily upper middle-class White populations used the Internet in its early~     years, however, Internet use within African-American and Latino households has recently~     increased dramatically, especially on online social networks such as Facebook.com. People~     using the Internet may be at the highest risk for contracting HIV and are using novel~     Internet approaches to find sex partners, such as through online social networks. This is the~     first study to examine the effectiveness of the HOPE social media intervention to increase~     HIV testing among at-risk groups in the United States.~   "
47523|NCT02944864|"~     To study the pharmacokinetic characteristics of TQ-B3395 in the human body, recommend a~     reasonable regimen for subsequent research.~   "
47524|NCT02944851|"~     The aim of this work is determine the more successful noninvasive method by comparison of two~     noninvasive methods ( IVC ultrasound - noninvasive hemoglobin measurement (SpHb)) that used~     in the detection of patients with blood loss.~      The works were completed in 6 months. The study was conducted at the blood donation center~     and in Emergency department. Vital parameters were measured and recorded before making the~     voluntary blood donation. Following Masimo brand portable device fingers SpHb value was~     measured.Then IVC diameter of patients in the supine position were measured using~     ultrasonography. Then he left to donors return in routine blood donation programme. A unit~     (500ml) of blood were drawn from each donor. After the blood donation process measured and~     recorded the vital signs again. SpHb was measured noninvasively from finger again. Following~     these measurements were recorded again by measuring the diameter of IVC.~   "
47525|NCT02944838|"~     Senior Change Makers is an intergenerational intervention that compares two, 8-week programs:~     (1) an advocacy program wherein senior participants perform audits of their physical activity~     environments, identify an advocacy project, and advocate for improvements; and (2) a walking~     program designed to increase participant physical activity through education and guided~     walks. The investigators expect that the advocacy program will produce greater improvements~     in seniors' advocacy skills, confidence, and attitudes at 8 weeks.~   "
47526|NCT02944825|"~     This study will be a single-institutional randomized, single-blinded prospectively controlled~     clinical trial of a single dose of Ciprofloxicin 500mg antibiotic tablet as prophylaxis at~     the time of office flexible cystoscopy with ureteral stent removal. The control group will be~     no prophylaxis oral antibiotics.~   "
47527|NCT02944812|"~     This trial intends: 1.To evaluate the concentration of Chidamide in the serum and~     cerebral-spinal fluid of PTCL patients at certain time points after taking the medicine, to~     evaluate the pharmacokinetics of Chidamide in these patients and its CNS (central nervous~     system) distribution.~      2. To evaluate the efficiency and safety of Chidamide in PTCL patients.~   "
47528|NCT02944799|"~     A randomized, double-blind, placebo-controlled trial including 160 consecutive patients who~     have been diagnosed with both rheumatoid arthritis (RA) and osteoporosis and have been~     treated with alendronate (ALN) for five years or more. Patients will be randomized to~     discontinuation or continuation of alendronate. Outcomes are measured using dual energy~     absorptiometry (DXA), High Resolution peripheral Quantitative Computer Tomography (HR-pQCT)~     and biochemical markers of bone metabolism and inflammation after 6 months, 1 and 2 years.~   "
47529|NCT02944786|"~     The overall aim of the project is to evaluate the Help Overcoming Pain Early model (which~     includes patient education, person-centered health dialogues and pain/stress management),~     which is an adolescent-centered school health prevention program when adolescents have~     chronic pain. This is an intervention that has the hypothesis to support students to manage~     their chronic pain. The primary outcome is self-efficacy. Secondary outcomes are self-rated~     health, quality of sleep, pain intensity and school attendance. The project aims to evaluate~     the intervention through qualitative and quantitative data collection by students and school~     nurses. The project has a hybrid design, which means that outcomes of the intervention and~     the evaluation of the implementation are taking place in the same data collection. The~     results of this project can be of great importance in the early detection of students with~     chronic pain and promote their confidence in their own ability to manage their symptoms.~   "
47530|NCT02944773|"~     Randomized crossover clinical trial in which is intended to assess the effect of facilitated~     tucking of premature infants during daily weight. Heart rate, respiratory rate and neo-scale~     stress (ALPS-Neo) be observed before, during and one hour after the weight, and compared with~     normal practice, without facilitated tucking device.~   "
47531|NCT02944760|"~     Chronic kidney disease is a renal injury and progressive and irreversible loss of kidney~     function and in its most advanced stage is called chronic renal failure. Although~     hemodialysis replace some kidney function, patients suffer some alterations characterized by~     uremic syndrome typically expressed by: motor neuropathy and/or autonomic neuropathy,~     cardiac or musculoskeletal myopathies, peripheral vascular changes, among others. Thus, the~     functional capacity and ability to exercise presents diminished these patients. The aim of~     this study is to verify the acute effect of low level laser therapy on the functional~     capacity of these individuals.~      The research will be developed in the hemodialysis unit of the Santa Clara hospital of Santa~     Casa de Misericordia de Porto Alegre and the patients will be evaluated before and~     immediately after the application of laser therapy protocol. Before the protocol will be~     evaluated pain in the lower limbs, Borg scale, level of physical activity through the~     International Physical Activity Questionnaire (IPAQ) and blood collection will be held for~     later analysis parameters of biochemical oxidative stress and deoxyribonucleic acid (DNA)~     damage.~      The laser therapy protocol will be applied in 6 points in quadriceps and 4 points in the~     gastrocnemius, bilaterally. After application, will be held the 6-minute walk test, effort~     subjective perception by Borg scale, assessment of pain in the lower limbs with visual analog~     scale and a new blood sample for further analysis. Patients will be randomized in two groups.~     The intervention group (IG), which will be held laser therapy and placebo group (PG), where~     the laser therapy will be placebo mode applied. The application will take place with the~     Chattanooga device, with the laser diode cluster probe from the same manufacturer consisting~     of five diodes 850 nanometers (nm) and power output of 200 milliwatts (mW). It is irradiated~     6 points in quadriceps and 4 points in gastrocnemius, bilaterally.~   "
47532|NCT02944747|"~     Background (brief):~        1. Burden: Bangladesh has a high maternal (194 per 100,000 live births) and newborn~          mortality (28 per 1000 live births). In 2010, prematurity represented ~14% of all births~          and directly and indirectly contributed to 45% of all neonatal deaths. Gestational age~          (GA) is a key determinant of newborn survival and long-term impairment. Accurate~          estimation of GA facilitates timely provision of essential interventions to improve~          maternal and newborn outcomes.~        2. Knowledge gap: Last menstrual period (LMP) is a simple, low-cost self reported~          information, recommended by the World Health Organization for estimating gestational age~          but has issues of recall mainly among poorer, less educated women and women with~          irregular menstruation, undiagnosed abortion, and spotting during early pregnancy.~          Several studies have noted that about 20-50% of women cannot accurately recall the date~          of LMP.~        3. Relevance: The goal of this study is to improve maternal and newborn outcomes by~          increasing the accuracy of gestational age estimation, using menstrual based dating,~          that is vital for providing timely and necessary obstetric and newborn care~          interventions. The study will determine the efficacy of three community based~          interventions using e-platform targeted to improve the recall and reporting of the date~          of last menstrual period in a rural resource poor setting. The innovative e-platform~          based interventions, if successful, can provide substantial evidence to scale-up in a~          low resource setting where e-Health and m-Health initiatives are proliferating with~          active support from all sectors in policy and implementation.~      Hypothesis :~        1. Implementation of conventional and e-platform based interventions will lead to a 30%~          improvement in recall of the date of the LMP in adolescent girls and married women in~          rural Bangladesh.~        2. Intervention triggered improvement in LMP date recall among pregnant women in rural~          Bangladesh will improve the accuracy in GA estimation.~      Objectives: The main objectives of the study are to:~        1. Determine whether a set of conventional and e-platform based interventions improve~          recall of the date of the LMP in adolescent girls and married women in rural Bangladesh.~        2. Determine whether intervention triggered improvement in LMP date recall in rural~          Bangladesh improves the accuracy in GA estimation or not~      Methods: A 4- parallel arm, superiority, community based cluster randomized controlled trial~     comparing three conventional and e-platform based interventions is proposed to improve recall~     of GA with a control arm. The trial will be conducted among adolescent girls and recently~     married women (within past two years) with no children or a single child in Mirzapur~     sub-district of Bangladesh.The interventions include (i) education and calendar for recording~     date of LMP (ii) education and SMS based system for recording dates of LMP and reminders~     using mobile phone (normal) (iii) education and smart-phone based application for recording~     dates of LMP with an inbuilt reminder system.~      Outcome measures/variables: The trial has two primary outcomes, (i) improvement in the recall~     of LMP date among enrolled participants in the three different intervention compared to~     control arm and (ii) increased accuracy of LMP-based gestational age measurement, as compared~     to USG, following the intervention.~   "
47533|NCT02944734|"~     The purpose of this study is to explore the optimal dose of fixed-dose combination of~     candesartan cilexetil and amlodipine besylate by examining the safety and efficacy of the~     combination therapy compared to each of the monotherapy in patients with essential~     hypertension.~   "
47534|NCT02944721|"~     The aim of the study is to establish the genetic, neurophysiological and psychological~     phenotype of the patients presenting a persistent neuropathic pain after surgery of the~     breast cancer, by comparing the neuropathic painful patients with the not painful and with~     the not neuropathic painful . This will be realized on a transverse cohort~     (Seintinellecohort) and confirmed on a forward-looking longitudinal cohort.~   "
47535|NCT02944708|"~     The purpose of this study is to examine the efficacy of maintenance chemotherapy for the~     treatment of metastatic nasopharyngeal carcinoma. Participants will be randomized to 3 arms.~     Arm 1, control group, participants will receive only 4-8 cycles of conventional chemotherapy;~     arm 2, participants will receive 6 cycles of maintenance chemotherapy after conventional~     chemotherapy; arm 3, experiment arm, after conventional chemotherapy, participants will~     receive maintenance chemotherapy until disease progression or intolerable toxicities.~   "
47536|NCT02944695|"~     Both patient and staff safety are of major importance during the procedure of fibreoptic~     bronchoscopy. Patient safety depends partly on adequate disinfection of instruments and~     accessories used as well as careful monitoring during the procedure.~   "
47537|NCT02944682|"~     This study is a randomized controlled trial of liquefied petroleum gas (LPG) stove and fuel~     distribution in 3,200 households in four countries (India, Guatemala, Peru, and Rwanda).~     Following a common protocol, each intervention site will recruit 800 pregnant women (aged~     18-34 years, 9 - <20 weeks gestation), and will randomly assign half their households to~     receive LPG stoves and an 18-month supply of LPG. Controls will receive the same cookstoves~     and LPG supply at the end of the study. The mother will be followed along with her child~     until the child is 1 year old. The researchers estimate that 25% of households will have a~     second, non-pregnant older adult woman (aged 40-79 years) who will also be enrolled at~     baseline and followed during the 18-month follow-up period. To optimize intervention use, the~     researchers will implement behavior change strategies informed by previous experiences and~     formative research in Year 1. This study will assess cookstove use, conduct repeated personal~     exposure assessments of household air pollution, and collect dried blood spots and urinary~     samples for biomarker analysis and biospecimen storage. The primary outcomes are low~     birthweight, pneumonia incidence, and linear growth in the child, and blood pressure in the~     older adult woman. Secondary outcomes include preterm birth and gross motor development in~     the child, maternal blood pressure during pregnancy, and endothelial function, respiratory~     impairment, carcinogenic metabolites, and quality of life in the older adult woman.~   "
47538|NCT02944669|"~     This study seeks to further evaluate the Multi-Tiered Training Program and to further explore~     the overall safety profile of the ReWalk Personal Device outside of the institutional setting~     under conditions of routine medical practice.~   "
47539|NCT02944656|"~     This is a randomized controlled trial of gabapentin 600 mg compared to placebo given 1-2~     hours preoperatively in conjunction with perioperative paracervical block for surgical~     abortion. The researchers hypothesize that adding gabapentin to local anesthesia will reduce~     perioperative and postoperative pain associated with surgical abortion. Additionally, the~     researchers hypothesize that gabapentin will reduce nausea, vomiting, anxiety, and~     consumption of pain medication.~   "
47540|NCT02944643|"~     Chronic liver disease and cirrhosis pose a huge financial burden to the health care system.~     This includes the cost of medical care, employment, disability-related issues and reduced~     survival. Specifically, the complication of cirrhosis known as hepatic encephalopathy (HE)~     especially hinders quality of life, the performance of activities of daily living and the~     ability to drive a motor vehicle in affected subjects. The hidden burden to family members~     and caregivers of these subjects, however, has been all but ignored to date. Evaluation of~     family members and caregivers is essential. The burden of caring for someone with liver~     disease can result in added cost for health care for family members and caregivers and is~     typically not recognized. The importance of the burden to families and family members or~     caregivers resulting from other neurological diseases such as Alzheimer's has been well~     evaluated and specific strategies to educate and counsel family members and caregivers have~     been elaborated. This is important because as the findings of this study have emerged, we~     have found that both Veterans and non-Veterans with cirrhosis and HE have a poor quality of~     life, worse socio-economic status and place a significantly higher burden on their family~     members or caregivers than those without HE~   "
47541|NCT02944630|"~     The aim of this study is to determine the benefits of individual psychotherapy on quality of~     life for people with psoriasis receiving medical treatment versus a control group (awaiting~     group) treated with medical treatment, without psychotherapy.~   "
47542|NCT02944617|"~     This randomized clinical trial studies how well probiotic yogurt supplement works in reducing~     diarrhea in patients with kidney cancer that has spread from the primary site to other places~     in the body and that are being treated with sunitinib. Studying samples of blood and stool~     from patients who eat probiotic yogurt and those who avoid probiotic yogurt may help doctors~     plan better treatment.~   "
47543|NCT02944604|"~     The purpose of the study is to evaluate the efficacy and safety of PEG-rhG-CSF in patients~     with breast cancer who were treated with intensive chemotherapy for prevention of neutrophil~     reduction.~   "
47544|NCT02944591|"~     The purpose of this research study is to investigate the potential benefits of participant~     use of a smartphone application (App) called COPD Co-Pilot™. When used by the participant,~     COPD Co-Pilot™ may provide early detection of worsening COPD symptoms. Early symptom~     detection may allow the pulmonary providers and nurses to respond with timely medical advice~     and treatment. The goal for use of COPD Co-Pilot™ is to reduce the frequency and duration of~     hospitalizations, emergency department visits, and hospital readmissions. The study will also~     examine the financial impact of the COPD Co-Pilot™ program to determine whether costs of~     hospital stays, emergency department visits, and hospital readmissions differ when patients~     are enrolled in COPD Co-Pilot™ than when they are not enrolled. Another purpose of this study~     is to measure patient satisfaction with use of COPD Co-Pilot™.~   "
47545|NCT02944578|"~     The purpose of this study is to see if curcumin can reverse a cervical precancerous state by~     looking at people who have the condition and intervening with a study drug or placebo (an~     inactive drug), prior to planned therapeutic loop electrosurgical excision procedure (LEEP)~     which is a treatment procedure for removing cervical cancer. 40 women with high grade~     squamous intraepithelial lesion (HSIL) of the cervix will be enrolled to either insert 2000~     mg capsule of curcumin or a placebo in their vagina daily for 12 weeks. After a 4 week long~     washout period the participants will then undergo removal of the precancerous cells as~     recommended standard of care. Participants will have regular monthly visits for the duration~     of the study.~   "
47546|NCT02944565|"~     This phase II trial studies the side effects and how well daratumumab works in treating~     patients with multiple myeloma when the infusion is accelerated. Monoclonal antibodies, such~     as daratumumab, may interfere with the ability of tumor cells to grow and spread.~   "
47547|NCT02944552|"~     The study adopted the superiority design of multi center, randomized, double-blind, positive~     control drug, dose finding, using two simulation skills. The qualified subjects, according to~     the ratio of 1:1:1, were randomized into low dose group, high dose group and positive drug~     control group, and received a treatment course of 4-8 weeks, all individuals were followed up~     for 4 weeks after drug withdrawal.~   "
47548|NCT02944539|"~     Compelling epidemiological evidence indicates that alterations of mitochondrial DNA,~     including mutations and abnormal content of mitochondrial DNA (mtDNA), are associated with~     the initiation and development of gastric cancer.The aim of this study was to explore~     association between mtDNA content in peripheral blood cells could be used as a risk predictor~     for gastric cancer.~   "
47549|NCT02944526|"~     Patients presenting with subacute, less than 6 months of evolution, adhesive capsulitis are~     randomly attributed to the control or study group. Both groups receive a series of 3~     suprascapular nerve blocks under ultrasound guidance with either 5ml saline or 5ml~     ropivacaine 2mg/ml ( ref) at 1 week interval. Testing consists of glenohumeral range of~     motion (ROM) (anterior elevation, lateral elevation, external and internal rotation) measured~     by goniometer, Constant score and visual analog scale (VAS) pain score. Evaluations are done~     immediately before and one hour after every suprascapular block and at 4 weeks after the~     third suprascapular block.~      All suprascapular nerve blocks are performed by one physician and the evaluations are done by~     a occupational therapist or MD experienced in glenohumeral function evaluations. All~     practitioners are blinded to the assigned group.~      All patients continue their pre-study treatment of physiotherapy and per os pain medication.~     Patients keep a record of analgesics and NSAID use during the trial. Drop-out rate is~     measured.~   "
47550|NCT02944513|"~     Research Objectives: This is a 1-year trial designed to gather information about the use of~     the Quell for persons with chronic musculoskeletal low back pain. The investigators~     hypothesize that those assigned to using the device will report reduced back pain compared~     with those in the control condition; with those using the device also showing improvement in~     sleep, mood, and level of activity. The investigators hypothesize that frequency of using the~     Quell (increased tolerability and adherence) will be correlated with greater reduction in~     pain. The investigators hypothesize that the device will be safe to use and will demonstrate~     a reduction in healthcare utilization (reduced clinic and ED visits). Finally, based on~     preliminary analyses limited by few subject numbers, the investigators will investigate~     whether certain individuals report greater benefit from using the Quell than others and, in~     particular, would predict that those with more intense and longer duration of pain will~     demonstrate most benefit.~   "
47555|NCT02944448|"~     The study schedule consists of a Screening Period (up to 14 days), a blinded 4- week~     Titration-to-Effect Period with weekly visits, a blinded 4-week Maintenance Treatment Period~     at the optimal dose level determined for each patient, and a 1-week Follow-up Period.~      Eligible patients will be randomized to receive either CR845 or placebo in a 2:1 ratio. Every~     patient will be started on a 1-mg dose of CR845 or matching placebo. During the~     post-randomization Titration-to-Effect period, the dose of study drug may be increased to 2.5~     mg or 5 mg in a double-blind fashion. Patients may know their dose is being changed but will~     not know whether they were randomization to active study drug or placebo. Approximately 330~     patients will be enrolled in this study.~   "
47556|NCT02944435|"~     This is a Phase 1, randomized, single-dose, 2-way crossover PK comparability study of CB-839~     administered as capsule and tablet formulations in healthy adult subjects.~   "
47557|NCT02944422|"~     This study is designed to determine the prevalence of oral habits among primary Egyptian~     school children in Cairo Governorate, Egypt.~   "
47558|NCT02944409|"~     This post-market clinical follow-up study intends to investigate long-term functionality of~     the VEGA System®. The design of the VEGA System® is meant to provide the patient with more~     knee mobility compared to their pre-operative state.The endpoint is the revision of at least~     one of the prosthesis components~   "
47559|NCT02944396|"~     This study seeks to establish the recommended Phase 2 dose (RPTD) of veliparib in combination~     with nivolumab and platinum doublet chemotherapy (carboplatin/paclitaxel or~     carboplatin/pemetrexed) (Phase 1 portion) and to assess whether the addition of nivolumab to~     veliparib in combination with platinum doublet chemotherapy results will improve progression~     free survival (PFS) compared to veliparib with platinum doublet chemotherapy alone in~     participants with metastatic or advanced Non-small Cell Lung Cancer (NSCLC) (Phase 2~     portion).~   "
47560|NCT02944383|"~     A 12-Week, Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy~     Safety and Tolerability of Gemcabene in Subjects with Severe Hypertriglyceridemia (INDIGO-1)~   "
47561|NCT02944370|"~     The investigator is pilot testing the feasibility and impact of a low-cost intervention that~     uses existing gymnasiums, and therefore has the potential to be replicated across the United~     States. The intervention, PlayFit, is designed for adults aged 21-50. PlayFit has five key~     components, intended to overcome the major barriers to physical activity. First, it will~     assist people in finding others to play with, using the Pick-Up model of designating times to~     play and making those times known in the community. Second, it will overcome a lack of~     confidence in physical activity by including games of lower intensity for relatively unfit~     adults, then building up to moderate and vigorous games. Third, it will require team members~     of varying ages and genders to encourage intergenerational play. Fourth, it will use modified~     equipment (e.g., softer, lighter balls) and smaller game space to require less running, so~     that even relatively unfit people can feel confident participating. Fifth, it will be~     designed to be led by community volunteers, which will increase its disseminability.~      AIM - Understand the optimum design for PlayFit. To meet this aim, the investigators will~     come up with a list of games to play and pilot the games at a gymnasium. The investigators~     will observe the participants playing the games and have them complete a brief survey.~   "
47562|NCT02944357|"~     This pilot clinical trial studies how well gemcitabine hydrochloride, cisplatin, and~     AGS-003-BLD work in treating patients with bladder cancer that has spread to the muscle and~     who are undergoing surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride and~     cisplatin, work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Vaccines made from~     a person's tumor cells may help the body build an effective immune response to kill tumor~     cells. Giving gemcitabine hydrochloride, cisplatin, and AGS-003-BLD before surgery may make~     the tumor smaller and reduce the amount of tissue that needs to be removed by surgery.~   "
47563|NCT02944344|"~     The purpose of this study is to see whether patients with metastatic breast cancer, their~     caregivers, and their healthcare providers can improve in shared decision making (SDM) and~     preparedness around end of life (EOL) planning through participation in Reimagine's online~     Four Conversations™ program. The goal is to close clinical practice gaps and enhance the~     quality of care for patients with metastatic breast cancer through increased competence and~     performance of healthcare providers and healthcare systems.~   "
47564|NCT02944331|"~     The aim of this study is to evaluate the long-term effects of endovenous steam ablation~     (EVSA). Postoperative data at 3-4 year follow-up will be collected from patients treated with~     EVSA.~   "
47565|NCT02944318|"~     School is a favorable environment for the development of actions aimed at healthy behavioral~     changes. This project proposes to evaluate the effectiveness of an intervention program on~     aspects of lifestyle, with a focus on physical activity (PA) and reducing sedentary~     behaviors, and the relationship of these factors with the academic performance of students in~     the school from Florianopolis, SC, Brazil.~      This is a randomized controlled intervention study enroling classes of 7th to 9th grade of~     fundamental education.~      The intervention program will last for one year (about ten months), with three focuses:~     training of teachers, educational and environmental changes to behavior change.~   "
47566|NCT02944305|"~     Failure in airway management is one of the most common anesthesia-related morbidity and~     mortality. Each individual airway assessment has limitation to predict difficult intubation.~   "
47567|NCT02944292|"~     The purpose of this study is to evaluate the effect of deepening of sedation on~     intra-abdominal pressure in mechanically ventilated adult patients with intra-abdominal~     hypertension.~   "
47602|NCT02943824|"~     The proposed, mono-institutional, randomized-controlled trial aims to determine whether the~     dosimetric outcomes following prostate Low-Dose-Rate (LDR) brachytherapy, planned using a~     novel machine learning (ML-LDR) algorithm, are equivalent to manual treatment planning~     techniques. Forty-two patients with low-to-intermediate-risk prostate cancer will be planned~     using ML-LDR and expert manual treatment planning over the course of the 12-month study.~     Expert radiation oncology (RO) physicians will then evaluate and modify blinded, randomized~     plans prior to implantation in patients. Planning time, pre-operative dosimetry, and plan~     modifications will be assessed before treatment, and post-operative dosimetry will be~     evaluated 1-month following the implant, respectively.~   "
47568|NCT02944279|"~     The acute respiratory distress syndrome (ARDS), characterized by alveolar flooding with~     protein-rich pulmonary edema fluid, is one of the most common disease in the intensive care~     unit (ICU) throughout the world. In recent years, much effort has been focused on the~     biological markers for their potential values to diagnose ARDS and outcomes.~      ARDS is generally accompanied by the disruption in alveolar-capillary barrier permeability,~     which subsequently caused an influx of neutrophils into the interstitium and alveolar space.~     It was reported that the aggregation, adhesion activation and release proteases of~     neutrophils are the key pathogenesis of ARDS pulmonary edema. Neutrophil Elastase (HNE), the~     most crucial protease generated in neutrophil azurophilic granules, plays an important role~     in various inflammations, especially the lung injury. The destructive action of HNE on almost~     all extracellular matrix influences cell signaling through cleavage of surface receptors.~     Once released in circulation, HNE is rapidly inactivated by conjugation with PI3. This local~     inhibitor reduces HNE mediated tissue injury and inflammation. Thus, the investigators plan~     to conduct a cohort study with repeated measures to examine the diagnostic and prognostic~     value of HNE and PI3 for ARDS.~   "
47569|NCT02944266|"~     This is an observational study to evaluate the role of a Bed side Focus assessed~     Transthoracic Echocardiography (FATE) in identifying the patients at a potential risk of~     developing hypotension secondary to general anesthesia induction using the FATE parameters~     like velocity time integral ( VTI ), Inferior venacava diameter , Caval index and Left~     ventricular end end diastolic area.~   "
47570|NCT02944253|"~     Two dietary approaches, very low energy diets (VLEDs) and ketogenic low carbohydrate diets~     (KLCDs), have the ability to suppress appetite. The suppression of appetite typically~     observed during these diets is believed (but not clinically proven) to be due to ketosis, a~     condition where circulating concentrations of ketone bodies are increased due to a higher~     production of ketones in the liver. Little is known about the potential mechanisms through~     which ketosis may lead to appetite suppression in VLEDs and KLCDs. A 'ketogenic diet'~     typically contains less than 50 grams carbohydrate per day, yet ketosis has been seen in~     subjects who consume diets with a carbohydrates ranging between 59-192 grams per day.~     Although an association between ketosis and appetite suppression has been established, the~     minimum level of ketosis and maximum carbohydrate intake that is still associated with~     appetite suppression remains unknown and should be explored. The ability to increase~     carbohydrate intake while maintaining a suppressed appetite will allow dieters to consume~     more carbohydrate-rich food that is beneficial for health without feeling more hungry. The~     aim of this study is, therefore, to identify the maximum carbohydrate intake that is still~     associated with appetite suppression in a low energy diet and to determine the impact of a~     higher carbohydrate intake on appetite suppression, body composition, and resting metabolic~     rate.~   "
47571|NCT02944227|"~     The objective of this pilot study is to evaluate the efficacy of intensive fixed monthly~     dosing of intravitreal Lucentis® (Ranibizumab) for the treatment of SRF and PED in~     neovascular AMD which is persistent to anti-VEGF (anti-vascular endothelial growth factor)~     monotherapy.~   "
47572|NCT02944214|"~     The purpose of this study is to determine whether febuxostat and benzbromarone could protect~     renal function in chinese, and which one could be better.~   "
47573|NCT02944201|"~     This will be a single arm, window of opportunity study in men with treatment-naïve prostate~     cancer who will proceed to prostatectomy. Men will be treated with carvedilol prior to~     undergoing prostatectomy.~   "
47574|NCT02944188|"~     In this study, the investigators have compared the clinical outcomes of the laparoscopic and~     open right hemicolectomy within enhanced recovery after surgery (ERAS) programs in the~     treatment of right-sided colon cancer.~   "
47575|NCT02944175|"~     Cholinesterase inhibitors such as Neostigmine and Edrophonium have been used to reverse~     neuromuscular blockade after surgery. However, these drugs have a relatively slow onset and~     have adverse effects associated with stimulation of muscarinic receptors. In addition,~     neostigmine cannot be used to reverse profound blockade.~      Anesthetics may exert their effects on various facets of cerebral function such as cerebral~     metabolic rate (CMRO2), cerebral blood flow (CBF), cerebral blood flow-metabolism coupling,~     intra cranial pressure (ICP), autoregulation, vascular response to CO2 and brain electrical~     activity. The net result of all these effects of the anaesthetic agents combined with their~     systemic effects may prove beneficial or detrimental to an already diseased brain.~      In neurosurgical patients, clear and rapid recovery is required to early assess the~     neurological status and to maintain the cerebral oxygenation and metabolism within the normal~     physiological values which may be saved by sugammadex.~   "
47576|NCT02944162|"~     The purpose of this clinical trial is to study genetically engineered NK92 cell therapy in~     treating patients with CD33 positive acute myeloid leukemias that is relapsed (after stem~     cell transplantation or intensive chemotherapy) or refractory to further chemotherapy.~   "
47577|NCT02944149|"~     The study is a non-inferiority randomized controlled trial (RCT) that aims to demonstrate~     that tubal ligations by minilaparotomy (ML) conducted by trained clinical officers (COs) are~     no less safe as compared to those conducted by assistant medical officers (AMOs) in Tanzania.~     Participants will be randomized in a one to one ratio to ML by a CO and ML by an AMO. In~     addition to the screening and enrollment/ML visit, there will be three scheduled follow-up~     visits at 3, 7 and 42 days post-surgery.~   "
47578|NCT02944136|"~     The proposed randomized controlled trial will test the efficacy of a stepped collaborative~     care intervention, versus enhanced usual care arm, to reduce depression of cancer caregivers.~     Biobehavioral factors will include assessment of changes in health behaviors and biomarkers~     of inflammation. The investigators will also include measures metabolic abnormalities and~     clinical markers of CVD. The investigators expect few cardiac events during the study period.~     The investigators will also measure other health outcomes but CVD risk factors will be the~     focus of the study.~   "
47579|NCT02944123|"~     East Asian patients will be required optimal dose of newer P2Y12 inhibitors (prasugrel or~     ticagrelor) to determine the safer treatment and better outcome. Whether lower dose of these~     regimens are more adequate for clinical practice in Korea is unclear. Therefore, the~     investigators aim to evaluate efficacy and safety of half dose of new oral P2Y12 inhibitors~     in Korean patients with acute coronary syndrome (ACS) undergoing percutaneous coronary~     intervention (PCI).~   "
47580|NCT02944110|"~     Patients with diabetes are characterised not only by compromised insulin secretion and~     action, but also by elevated plasma levels of the 29-amino acid peptide hormone glucagon,~     which hitherto has been considered a pancreas-derived hormone (produced in and secreted from~     alpha cells in the islets of Langerhans). In patients with diabetes, circulating glucagon~     concentrations are elevated in the fasting state and fail to decrease appropriately or even~     increase in response to an oral glucose tolerance test (OGTT) or after ingestion of a mixed~     meal. Hyperglucagonaemia is known to be a potent stimulator of hepatic glucose output, and,~     thus, contributes significantly to the fasting and postprandial hyperglycaemia characterising~     patients with diabetes. Despite intense research over the years the mechanisms behind the~     elevated glucagon levels in diabetes is still not clear. Recently, the investigators showed~     that totally pancreatectomised patients also show a hyperglucagonaemic response during OGTT,~     a finding that suggests that the pancreas is not the only source of glucagon production in~     man.~      In the present project, the investigators wish to evaluate the impact of gastrointestinally~     derived glucagon secretion observed in totally pancreatectomised patients on postprandial~     glucose tolerance.~      The investigators hypothesise that antagonisation of glucagon signalling (from~     gastrointestinally derived glucagon) in totally pancreatectomised patients will improve or~     perhaps normalise the patients glucose tolerance during a 75g-OGTT. In order to test this~     hypothesis, the investigators wish to apply the potent and selective oral antagonist of the~     human glucagon receptor LY2409021 and placebo, respectively.~      The study is a randomised, placebo-controlled, double-blinded, cross-over study.~      10 healthy persons and 10 pancreatectomized patients (i.e. patients who have had their~     pancreata removed due to pancreatic cancer or severe chronic pancreatitis) will be subjected~     to two experimental days with LY2409021 and placebo, respectively, on which they will undergo~     an OGTT followed by a fasting period and finished off with an ad libitum meal.~   "
47581|NCT02944097|"~     To enhance the oral bioavailability of the antioxidants trans-resveratrol and~     trans-ε-viniferin from Vineatrol30 grapevine-shoot extract, the native powder was~     incorporated into micelles. A single dose, single blind, two arms crossover trial was~     conducted. Plasma and urine samples were collected at intervals up to 24 h after oral intake~     of native or micellar Vineatrol30 (500 mg), and resveratrol content was quantified and~     compared between formulations. Tolerability of the dose was also controlled by safety~     parameters in plasma.~   "
47582|NCT02944084|"~     The oral absorption and urinary excretion kinetics of the bioactive ingredients from rice~     bran (gamma-oryzanol, tocotrienols, tocopherols and ferulic acid esters) after incorporation~     into an oat porridge (oat porridge) compared to unprocessed rice bran extract oil were~     investigated. The influence of the type of preparation (with water vs. milk) of porridge on~     the bioavailability of the bioactive compounds was compared. The study followed a single dose~     (2 g rice bran extract), randomized, three armed crossover study design with ≥1-week washout~     periods. Plasma and urine samples were collected at intervals up to 24 h after intake.~   "
47583|NCT02944071|"~     This clinical study is a prospective, non-randomized, multicenter study to demonstrate the~     acceptable safety and performance of angioplasty with the Ranger DCB in native~     femoropopliteal artery lesions. It is intended that all patients with qualifying lesions~     would be considered for enrollment and treated with the Ranger DCB catheter. Approximately~     123 patients with femoropopliteal artery lesions will be enrolled. All lesions will be~     treated with the Ranger DCB. Up to 15 clinical sites located in China are expected to~     participate.~   "
47584|NCT02944058|"~     The purpose of the project is to compare the management of 3 and 4 part proximal humerus~     fractures (PHF) with an angular stable plate (Philos) with that of an intramedullary nail~     (Multiloc) in light of complications, radiological, economical, functional and clinical~     outcome.~   "
47585|NCT02944045|"~     Pneumocystis jiroveci pneumonia (PcP) increased in non HIV immunocompromised patients.~     Mortality remains high for those patients with comorbidities (50% for patients with the most~     severe Pneumocystis pneumonia). Physiopathology, characteristics and outcome of PcP in~     non-HIV patients remains different from those in HIV patients. Steroids in HIV patients with~     PcP has been associated with decreased mortality but in non-HIV patients, adjunctive steroids~     remains controversy. Some retrospective studies in that field did not find any beneficial~     effects of steroids ((1mg/kg/jour d'Equivalent Prednisone (EP)). However, all the studies~     were retrospective, non randomised studies including various underlying disease and severity~     of PcP was variable. Moreover, dosage and delay of steroids were variable leading difficult~     to interpret all the results.~      The investigators want to demonstrate the beneficial effect of steroid during PcP in non-HiV~     immunocompromised patients with a double blinded randomised clinical trials comparing~     adjunctive steroids to placebo.~   "
47586|NCT02944032|"~     Th main objective of the study is to assess the efficacy of a home-based, computerized~     cognitive training (CT) program, called CogmedRM, targeted to improve working memory in~     children with NF1 and working memory difficulties.This is a Phase II randomized parallel~     group controlled clinical trial comparing two interventions on cognitive outcomes.~     Participants will be stratified by stimulant medication use and randomized equally between~     the two interventions within stratum. Participants will be in the study for to 11 weeks.~   "
47587|NCT02944019|"~     In order to understand the risks and benefits of edoxaban use in a real-world clinical~     setting in the Non-valvular Atrial Fibrillation (NVAF) indication, Daiichi-Sankyo proposed~     this post-authorization safety study (PASS) to gain insight into the safety (bleeding, liver~     adverse events, all-cause mortality and other drug related adverse events) of edoxaban use in~     patients with NVAF who were not preselected.~   "
47588|NCT02944006|"~     This study aims to establish radiomics database for pancreas cancer from multiparametric MRI~     including DCE-MRI obtained by using incoherent undersampling and radial acquisition for~     clinical staging as well as quantitative analysis.~   "
47589|NCT02943993|"~     According to current guidelines, duration of anticoagulant treatment after a venous~     thromboembolic event varies from 3 months to indefinite treatment depending on the estimated~     risks of venous thromboembolism (VTE) recurrence and bleeding. Current data for edoxaban are~     limited to a maximum treatment duration of 12 months (Hokusai-VTE; N Engl J Med. 2013;~     369:1406-15).~      Therefore, this study aims to gather further insight into efficacy (i.e. symptomatic~     recurrent VTE) and safety (i.e. bleeding events, liver adverse events, all-cause mortality~     and other drug related adverse events) of extended treatment with edoxaban up to 18 months in~     an unselected patient population in routine clinical practice.~   "
47590|NCT02943980|"~     A randomized controlled prospective study of laryngoscopy and evaluation of the~     Intraoperative nerve monitoring during thyroid surgery comparing direct laryngoscopy and the~     McGrath® Mac videolaryngoscope.~   "
47591|NCT02943967|"~     The purpose of this study is to evaluate safety and efficacy of corneal cross-linking and~     photorefractive keratectomy for refractive correction in patients with bilateral asymmetric~     topography.~   "
47603|NCT02943811|"~     The investigators sought to retrospectively assess whether the use of a intrauterine device~     to manipulate the uterus does affect the long-term oncologic outcomes of patients operated by~     laparoscopy for endometrial cancer~   "
47592|NCT02943954|"~     Although current guidelines recommend fractional flow reserve (FFR) to identify~     haemodynamically relevant coronary lesion(s) in stable patients when evidence of ischaemia is~     not available (Class I, Level of Evidence: A), no published study has assessed the usefulness~     of FFR to guide percutaneous coronary intervention (PCI) in ST-elevation myocardial~     infarction (STEMI) patients with multi-vessel disease (MVD).~      The main objective of this study is to determine whether, in STEMI patients with MVD amenable~     to PCI, the use of FFR in addition to angiography will improve cardiovascular outcomes,~     compared with the current practice of angiography- guided PCI, by improving the~     appropriateness of revascularisations by assessing the relevance of non-culprit lesions in~     the context of STEMI with multivessel coronary artery disease.~      The secondary objective is to assess the safety and the cost-effectiveness of the FFR-guided~     strategy compared to the angiography-guided strategy.~   "
47593|NCT02943941|"~     The purpose of this study is to understand how the pressure in the pulmonary artery changes~     under different conditions of posture, respiration and exertion.~   "
47594|NCT02943928|"~     laryngoscope combined with chest CT in double lumen endotracheal tube accurate positioning~   "
47595|NCT02943915|"~     A randomized, controlled trial comparing exoskeleton gait training with standard gait~     training or no gait training in community-dwelling participants with chronic incomplete~     spinal cord injury~   "
47596|NCT02943902|"~     This study will evaluate the immunogenicity of a reduced dosing schedule of Pneumococcal~     Conjugate vaccine (PCV) PCV10 and PCV13, in which children will receive a primary dose at~     either 6 or 14 weeks of age, followed by a booster dose at 9 months of age (1+1 schedule),~     and compare this immune response to those who receive a two dose primary series (at 6 and 14~     weeks of age) and booster dose at 9-months (2+1 schedule).~   "
47597|NCT02943889|"~     Chronic liver disease end by liver cirrhosis and increases the risk of cancer development.~     Chronic liver disease in Egypt is recognized as a serious health problem affecting greater~     than (20 %) of the population, where the main cause is chronic infection.~      Liver transplantation is still the standard treatment for advanced decompensated liver~     cirrhosis. However, this treatment is quite limited in clinical practice. Therefore there is~     a concerted effort around the world to develop regenerative and alternative therapies, so,~     stem cell-based therapies are emerging as new alternatives to liver transplantation for~     end-stage liver pathologies.~   "
47598|NCT02943876|"~     Major depressive episode (MDE) is one of the most prevalent and disabling form of mental~     illness in the general population. Despite increased mental health services and~     antidepressants use in the past 10 years, there has been no measurable change in the~     prevalence of MDE in the Canadian general population, which motivates the search for~     additional strategies for reducing the burden of MDE. One strategy that has been successful~     in the fields of oncology, cardiology and diabetes is early identification and prevention -~     identifying people who are at high risk and taking preventive actions to lower the risk so as~     to prevent symptoms from progressing into a MDE. As multivariable risk prediction algorithms~     are used to estimate an individual's risk (probability) of future disease, they can play an~     important role in the process of early identification. The proposed study stems from a~     project funded by an operating grant from the Canadian Institutes of Health Research (CIHR).~     With the CIHR support, the team developed and validated sex-specific prediction algorithms~     for MDE. As risk prediction is at very early stage in psychiatry and MDE is still highly~     stigmatized, to facilitate the future implementation of the developed risk prediction~     algorithms, the proposed study seeks to answer the following research questions: (1) Does~     disclosure of personalized depression risk information promote high-risk individuals to take~     preventive actions? (2) Will disclosure of personalized depression risk information~     negatively affect high-risk people's mental health status in terms of increased psychological~     distress? To answer the questions, the investigators planned to conduct a randomized~     controlled trial (RCT) with an embedded qualitative component. The proposed study will~     develop an evidence base for guiding the disclosure of personalized risk information and~     understanding the process of risk communication and consumer empowerment, contributing to the~     advancement of early prevention of MDE in Canada.~   "
47599|NCT02943863|"~     High-flow nasal cannula (HFNC) that uses heated and humidified oxygen was recently introduced~     for bedside care. It has been shown to be associated with reduced risks of tracheal~     intubation rates and mortality in adult hypoxic patients.~      The mechanisms of the effects of HFNC are thought to be related to the favorable effects of~     the heated and humidified gas, the high-flow rate used to minimize the entrainment of room~     air, and an increase in the ventilation efficiency, including the elimination of~     nasopharyngeal dead space, positive end-expiratory pressure (PEEP) effects, and improvements~     in paradoxical abdominal movement. Regarding the effects on lung volume, global ventilation~     in the lungs increases during HFNC, which is thought to attribute to PEEP effects. However,~     how regional ventilation is affected during HFNC in comparison with conventional NC remains~     unknown.~      Because PEEP in mechanically ventilated patients improves the regional homogeneity of~     ventilation, investigators postulated that HFNC via PEEP effects would result in more~     homogeneous regional distributions in the ventilation changes. Investigators therefore~     assessed global and regional ventilation in patients with hypoxia receiving care via HFNC~     using electric impedance tomography and compared these results with conventional nasal~     cannula.~   "
47600|NCT02943850|"~     The investigator is examining the safety of transplanting cells that have been engineered to~     produce a growth factor into the spinal cord of patients with Amyotrophic Lateral Sclerosis~     (ALS). The cells are called neural progenitor cells, which are a type of stem cell that can~     become several different types of cells in the nervous system. These cells have been derived~     to specifically become astrocytes, which is a type of neuronal cell. The growth factor is~     called glial cell line-derived neurotrophic factor, or GDNF. GDNF is a protein that promotes~     the survival of many types of neuronal cells. Therefore, the cells are called~     CNS10-NPC-GDNF. The investigational treatment has been tested in animals, but it has not~     yet been tested in people. In this study, we want to learn if CNS10-NPC-GDNF cells are safe~     to transplant into the spinal cords of people.~   "
47601|NCT02943837|"~     Background: Preoperative pathologic diagnosis of subepithelial tumor (SET) can improve~     clinical decision making. Although EUS-guided fine needle aspiration (FNA) is currently~     considered the standard method for sampling SET, its diagnostic yield is generally~     suboptimal. EUS-guided fine needle biopsy (FNB) of SET is safe and feasible with adequate~     histology obtained.~      Objective: To compare the diagnostic accuracy of EUS-FNA and EUS-FNB.~   "
47604|NCT02943798|"~     The primary endpoint is to compare the PFS (progress-free survival ) of etoposide plus~     carboplatin with paclitaxel combined with carboplatin as first-line treatment for advanced~     pulmonary large cell neuroendocrine carcinoma.~   "
47856|NCT02940509|"~     The goal of this research proposal is to determine if the intraoperative administrative of~     Ketamine and Magnesium during laparoscopic gynecologic surgery improves postoperative pain in~     patients on chronic opioid therapy for management of chronic pelvic pain.~   "
47605|NCT02943785|"~     When the upper chambers of a person's heart receive irregular electrical signals it causes~     abnormal rhythm in the heart beat. This is called atrial fibrillation.~      Atrial fibrillation increases the chance of having a heart attack or stroke. Some patients~     also get new heart valves using a catheter.~      Often doctors give patients a medicine called a vitamin K antagonist (VKA), because it is~     considered the standard care. This study will see how edoxaban compares to VKA in patients~     who got a new heart valve by using a catheter.~      The study will compare the two drugs for up to three years after heart valve replacement,~     looking at the drug's overall side effects (called adverse events) and major bleeding.~   "
47606|NCT02943772|"~     The investigators propose to examine the effect of local cooling of testis in participants~     with acute epididymitis or orchiepididymitis on participants reported pain level and~     analgetics consumption.~   "
47607|NCT02943759|"~     The trial is to test the resolution of pain, swelling and other signs of periapical infection~     and the antimicrobial efficacy when using the neem leaf extract compared to chlorhexidine as~     root canal irrigant in Pulpectomy treatment for children.~   "
47608|NCT02943746|"~     While new innovations in the care of extremely premature infants have led to decreased~     morbidity and mortality, poor postnatal growth remains as a major challenge. Early growth in~     the postnatal period influences neurodevelopmental and growth outcomes.~      This proposed study will challenge current nutritional regimens for infants < 1000 g birth~     weight (BW) by providing an exclusive human milk based diet with a higher amount of protein~     based on individual caloric and protein analysis of human milk utilizing targeted~     fortification. The investigators will evaluate the effects of a high versus standard protein~     enteral diet on growth and body composition in infants < 1000 g BW.~      There are no published studies evaluating the effect of an exclusive human milk protein diet~     on body composition in premature infants. Research has shown that infants who receive this~     diet achieve growth at targeted standards but body composition has not been evaluated. As an~     all human milk diet is well tolerated and associated with improved outcomes in the highest~     risk neonates, it is imperative to evaluate the benefits of a high protein exclusive human~     milk diet and the possible positive changes in body composition, specifically lean mass, in~     these infants.~      Results from this proposed study will immediately influence current nutritional practices and~     will provide landmark information regarding targeted fortification with provision of adequate~     protein providing the most optimal body composition in the most fragile and vulnerable~     infants.~   "
47609|NCT02943733|"~     The goal of this study is to establish maximum tolerated doses/recommended phase 2 dose~     (RP2D) of temozolomide (TMZ) and TAS-102 when these agents are used in combination and to~     evaluate the safety profile of this drug combination.~   "
47610|NCT02943720|"~     A multicentre, Double-blind, Placebo-Controlled, Randomized Trial to Assess the Efficacy and~     Tolerability of Two Dosing Regimens of AllerT, a Combination of Contiguous Overlapping~     Peptides Derived from Bet v 1, in Adults with Birch Pollen Allergic~     Rhinitis/Rhinoconjunctivitis~   "
47611|NCT02943707|"~     This study evaluates the effect of autologous bone marrow stem cells infusion (ABMSCi)~     therapy for liver diseases.Treatment group will receive ABMSCi and drugs therapy ,while~     control group will only receive drugs therapy.~   "
47612|NCT02943694|"~     Colorectal cancer is one of the leading deadly diseases in the world. Due to the TME (total~     mesorectal excision) for the last decades, the survival and relapse rate of rectal cancer~     patients have been considerably improved. However, anatomical limitations in pelvic space~     hinder the further optimization of surgical treatment Thus, the natural orifice transluminal~     endoscopic surgery (NOTES) emerges as an alternative surgical strategy. Of note, transanal~     total mesorectal excision (TaTME) , a new invention based on TME principle, NOTES conception~     and single port technique, has been prevailing both in West and East nations, with or without~     the abdominal laparoscopic assistance. Up to date, there are various kinds of instruments and~     patterns to complete TaTME with comparable clinical outcomes. However, flaws in each~     instrument remains according to the feedbacks. This study is therefore designed to clinically~     evaluate the feasibility and safety of the new instruments specifically for TaTME~     (CS-Compact, GelPoint pathway).~   "
47613|NCT02943681|"~     This study evaluates the non-specific effects on child mortality and morbidity of a second~     dose of measles in the second year of life. Half of the study participants will receive a~     second dose of measles vaccine at 18 months of age while the other half will receive a second~     dose of measles by 4 years of age or at the end of the study.~   "
47614|NCT02943668|"~     This phase II trial studies how well deferasirox works in treating patients with very low,~     low, or intermediate-risk anemia or myelodysplastic syndrome that depends on red blood cell~     transfusions. Deferasirox may treat too much iron in the blood caused by blood transfusions.~   "
47615|NCT02943655|"~     Abnormal uterine bleeding encompasses abnormalities in the regularity, duration of flow,~     frequency, and/or blood flow volume relative to normal menstruation. Of these menstrual~     abnormalities, heavy menstrual bleeding (HMB), defined objectively as a blood loss of 80 ml~     or more per menstrual cycle , which is unrelated to pregnancy or known pelvic or systemic~     disease.~   "
47616|NCT02943642|"~     This study evaluates the effectiveness — as judged by complete response — of a single~     four-day treatment with the fusion protein A-dmDT390-bisFv(UCHT1) compared to oral Zolinza~     (Vorinostat), in a randomized 2-arm trial after a maximum of 12 months of treatment. Patient~     eligibility is stage IB/IIB mycosis fungoides with mSWAT < 50 who have never had lymphoid~     disease or a prior bone marrow / HSCT transplant.~   "
47617|NCT02943629|"~     The study will test the efficacy of the Pentax AWSTM video laryngoscope (VLS) equipped with a~     P Blade (Figure 1) as the means to provide Apneic Oxygenation (AO) and prolong Duration of~     Apnea Without Desaturation (DAWD) in non-obese and morbidly obese females.~   "
47618|NCT02943616|"~     The ABSORB Post-Approval Clinical Study is a prospective, open-label, multi-center,~     single-arm, non-randomized trial to evaluate the safety of the use of ABSORB in a real-world~     setting following commercial physician training'and to observe the effectiveness of~     commercial physician training on appropriate vessel sizing.~   "
47619|NCT02943603|"~     This research study is being down to find what, effects, good and/or bad, adding~     Pembrolizumab to standard chemotherapy mFOLFOX before and after surgery have on the patient~     and the patient's cancer.~   "
47623|NCT02943551|"~     Unwarranted use of antibiotics for pediatric acute respiratory tract infections (ARTIs) and~     use of second-line, broad spectrum antibiotics for bacterial ARTIs has contributed to the~     rapid development of resistance in many strains of bacteria. Provider-parent communication~     during pediatric visits for ARTIs strongly influence antibiotic prescribing rates. The~     overall goal of this study is to develop and test a distance learning quality improvement~     (QI) program called Dialogue Around Respiratory Illness Treatment - DART. The DART program~     aims to improve provider communication practices and treatment decisions during pediatric~     ARTI visits, with the ultimate goal being to decrease rates of antibiotic prescribing for~     these illnesses in children.~   "
47624|NCT02943538|"~     Pragmatic clinical trial, randomized, controlled parallel, 3 group (group technology~     platform, call group and control group), developed in the monograph Reference Unit of~     Inflammatory Bowel Disease Valencia (single-center).~   "
47625|NCT02943525|"~     Vaginal packing is used routinely following vaginal reconstructive surgery, however, no~     recommendation regarding vaginal packing after laparoscopic sacrocolpopexy exists. Despite~     little data to support the practice, purported benefits better positioning and fixation of~     the mesh, improving incorporation of the mesh by its fixation and reduced blood loss.~     Patients often complain of discomfort associated with the packing or its removal. The aim of~     this randomized controlled is to compare the subjective impressions of pain and bother in~     women undergoing laparoscopic sacrocolpopexy treated with and without packing. The~     investigators also aim to assess differences in postoperative bacteriuria, urine retention~     and hemoglobin levels on day 5 after the surgery and surgery outcome and complications at one~     year after the surgery in those with and without packing.~   "
47626|NCT02943512|"~     This study is to assess if subjects receiving a clinically indicated implanted cardiac~     pacemaker or defibrillator can be safely discharge home the same day of the procedure.~   "
47627|NCT02943499|"~     The purpose of this study is to understand brain mechanisms of app-based mindfulness training~     in smokers ages 21 to 65 years.~   "
47628|NCT02943486|"~     The goal of this study is to evaluate the safety and efficacy of using mesenchymal stromal~     cell derivatives (dac-MSCs) in the treatment of chronic diabetic foot ulcers (type 1 and 2)~     in adults. A third of the participants will receive dac-MSCs and Triticum vulgare~     (Fitostimoline) in combination, the other third MSCs and Fitostimoline in combination, and~     the last third only Fitosimoline. This study will be a randomized, blind, and parallel and~     controlled-group trial.~   "
47629|NCT02943473|"~     The purpose of this research study is to test whether the drug ibrutinib (trademark name:~     IMBRUVICA®) is effective at preventing the development of multiple myeloma in people who~     currently have smoldering myeloma. The researchers conducting this trial) have reason to~     believe that ibrutinib can delay the development of multiple myeloma, thus giving people who~     currently have smoldering myeloma a longer period of time when they feel healthy and well.~      Smoldering myeloma is an abnormal condition that is considered to be an early phase of the~     disease multiple myeloma. In this disorder, there is an abnormal growth of plasma cells,~     which is a type of blood cell found in the bone marrow. This growth is not as severe in~     people with smoldering myeloma as it is in multiple myeloma, so people with smoldering~     myeloma do not have any symptoms and tend to feel well. However, they have a higher risk of~     developing multiple myeloma than people in the general population.~      Some people with smoldering myeloma are at an especially high risk of developing myeloma -~     50% of these people will develop multiple myeloma 2 years after they are diagnosed with~     smoldering myeloma. The investigators identify these people by looking at the amount of~     myeloma in the bone marrow (called bone marrow plasma cell percentage) and the amount of~     myeloma protein (called serum protein electrophoresis and serum free light chain assay)~     in the blood. To be considered high risk, individuals must have highly abnormal levels for~     these tests.~      Based upon current guidelines, people with smoldering myeloma do not require any treatment.~     However, known is that many of these people will develop multiple myeloma in the near future.~     Currently there have been no proven and effective way of preventing these people from~     developing multiple myeloma, which remains an incurable disease.~   "
47630|NCT02943460|"~     The primary objective of this study is to evaluate the safety and tolerability of GS-9674 in~     adults with primary sclerosing cholangitis (PSC).~   "
47631|NCT02943447|"~     The primary objective of this study is to evaluate the safety and tolerability of GS-9674 in~     adults with primary biliary cholangitis (PBC).~   "
47632|NCT02943434|"~     This study will examine differences in diet-induced thermogenesis (DIT) between a meal made~     of processed ingredients and an equivalent, isocaloric meal made of whole ingredients. For~     the purpose of this study processed foods (PFs) will be considered those that are purchased~     in a state that is modified from their whole food (WF) counterpart (e.g. shell eggs compared~     to powdered eggs). Research has shown that less energy is expended to digest processed foods~     than whole foods, which confers an advantage to processed foods in terms of caloric~     efficiency, but a disadvantage in terms of energy balance and weight loss. A 2010 study~     showed that subjects expended approximately 10% less energy to digest sandwiches made of~     white bread and cheese product compared to sandwiches made of whole grain bread and cheddar~     cheese. The intent of this study is to enhance those results and improve upon the study~     design by constructing meals to be more similar in the makeup of individual ingredients,~     making ingredient processing a more isolated variable. Subjects will be healthy CWU male~     students with a body mass index of 18.5 - 24.9 kg/m2. Metabolism will be assessed by repeated~     measurements of resting energy expenditure via indirect calorimetry. Measurements of baseline~     metabolism will be made; subjects will then be provided one of two meals, both comprised of~     rice, green beans, and eggs cooked in canola oil and equivalent but differing in processing~     status (e.g. brown rice and white rice, fresh cooked green beans and canned green beans,~     etc). Hourly metabolic measurements will be made post-meal for 6 hours. During this time~     subjects will be asked to minimize non-DIT deviations in metabolism; e.g. those due to~     physical activity, excitement level, etc. The procedure will be repeated one week later with~     the other meal so that changes in DIT can be assessed on a subject-by-subject basis. The~     results of this study will be assessed in the lens of weight loss, specifically dietary~     choices that affect energy balance. It is possible that consuming a diet that includes more~     whole foods (versus processed foods) would be beneficial to the attainment of a healthy body~     weight - either through potential weight loss or weight maintenance.~   "
47633|NCT02943421|"~     Placenta accreta is considered a severe pregnancy complication that may be associated with~     massive and potentially life-threatening intrapartum and postpartum hemorrhage.~     Life-threatening bleeding is the most common complication to be associated with this~     condition; the average blood loss at time of delivery is reported to be 3000-5500 mL, which~     leads to significant postoperative morbidity and death.~   "
47634|NCT02943408|"~     Recent Veterans of the OIF/OEF/OND conflicts are presenting in VA care with high rates of:~     PTSD, depression, anxiety, and alcohol abuse, reporting significant difficulties with~     community reintegration, and dropping out of mental health care at high rates. Surveys of~     recent Veterans show that Veterans want the VA to provide mental health care tailored to~     their concerns and reintegration priorities. The VA is committed to providing personalized,~     proactive, patient centered care (PCC); but little research or intervention development has~     been done on PCC in mental health care settings and preliminary research indicates Veterans~     may lack the skills and knowledge to be active partners in PCC. This study aims to examine~     PCC behaviors in VA mental health care and, informed by this data, develop a brief patient~     centered mental health intervention that will help recent Veterans take the lead in their~     care personalization and support their functional recovery. Results from this study will~     demonstrate the acceptability, feasibility, and preliminary efficacy of this intervention.~   "
47635|NCT02943395|"~     Light curing cements used for laminate veneers may be not totally cured in certain areas, so~     dual cured resin cements may solve this problem yet the dual cured cements containing amines~     cause yellowish discoloration of the veneers after time.~      A new dual cured cement which is amine free is introduced so the investigators have to try it~     clinically using parallel groups in randomized clinical trial.~   "
47636|NCT02943382|"~     Dry eye disease remains one of the most common complaints seen in ophthalmic clinics. Causes~     of dry eye are multifactorial, with the most common cause of evaporative dry eye disease~     being meibomian gland dysfunction (MGD).~      Fingerprick autologous blood (FAB) is a novel method which uses a patient's own blood to~     treat dry eye conditions.~   "
47637|NCT02943369|"~     Platelets and thrombus formation play a key role in the pathogenesis of acute coronary artery~     occlusion and subsequent myocardial infarction. Apart from mechanically opening the occluded~     artery with angioplasty, adjunctive antiplatelet treatment is of utmost importance. However,~     orally administered antiplatelet agents exhibit a delay in their onset of action in the~     setting of acute myocardial infarction and angioplasty is mostly performed without adequate~     platelet inhibition. Cangrelor is an intravenous antiplatelet agent which can provide almost~     immediate strong platelet inhibition. The investigators aim to compare a strategy of~     cangrelor administered on top of ticagrelor-an oral antiplatelet agent- vs ticagrelor alone,~     on their efficacy to inhibit platelet function in the early hours of an acute myocardial~     infarction.~   "
47638|NCT02943356|"~     Observational study to evaluate the effect of Tadalafil 5mg once daily on Erectile~     Dysfunction and QOL in Andropause patients with Erectile Dysfunction.~      Patients will be observed for 8weeks.~   "
47639|NCT02943343|"~     The China Pulmonary Thromboembolism Registry Study (CURES) is a prospective multicenter~     registry project initiated in January 2008 and consisting in obtaining an extensive data~     registry of consecutive patients with pulmonary thromboembolism.~        -  The main objective of this registry study is to help physicians to improve their~          knowledge on the natural history of pulmonary thromboembolism, including epidemiological~          characteristics, personal history, risk factors, clinical manifestations, diagnostic~          methods, therapeutic regimens, clinical outcomes, prognosis, etc..~        -  Secondly, this study is also aimed to find some useful information for some patients who~          are usually not recruited in randomized clinical trials (pregnant women, elderly~          patients, disseminated cancer, severe renal insufficiency, patients with~          contraindications to anticoagulation therapy, extreme body weight, etc).~        -  Thirdly, the ultimate purpose of CURES study is decreasing mortality, frequency of~          thromboembolic recurrences as well as bleeding complications and arterial events.~   "
47640|NCT02943330|"~     Depression is one of the most common psychiatric diseases, with prevalence estimates ranging~     from 5% to 20%. Depression is now recognized as a brain disease; it can be managed and~     treated effectively with a wide range of options, but its biological basis is still far from~     clear. Studies of monozygotic and dizygotic twin pairs suggest polygenic inheritance, with an~     overall heritability estimate between 40% and 70 %. Gene-environment interaction has been~     recognized for a long time in the pathophysiology of depression, and its best biological~     substratum at present is represented by the serotonin transporter (5-HTT) gene. It would be~     interesting to study association between the novel allelic variants or at least the~     triallelic 5-HTTLPR polymorphism and depression. Depression is common in patients with~     end-stage renal disease and to occur in about 20% to 30% of hemodialysis patients.~     Interferon-induced depression is estimated up to 50% among patients with hepatitis C. Several~     sets of observations support the supposition that cytokines, and proinflammatory cytokines in~     particular, are involved in depressive disorders. Depression sufferers have been reported to~     have elevated blood levels of interleukin 1 (IL-1), IL-6 and tumor necrosis factor α (TNF-α).~   "
47641|NCT02943317|"~     This is a Phase 1/1b, open-label, multicenter, dose-escalation and dose expansion trial to~     evaluate the safety, efficacy, PK and PD of defactinib (VS-6063) in combination with avelumab~     in epithelial ovarian cancer.~   "
47642|NCT02943304|"~     This prospective cohort study will determine the natural history of fetal exposure to Zika~     virus (ZIKV) and its effects on the fetus and newborn with emphasis on neurodevelopment~     outcome. Exposure of the fetus will be determined by maternal symptomatology, RT-PCR ZIKV~     (blood and urine) and serologic test specific for ZIKV. Neonates will be classified according~     to trimester of infection and as exposed and unexposed to ZIKV.~   "
47643|NCT02943291|"~     The primary aim of this trial is to investigate adipose tissue function in women with and~     without polycystic ovary syndrome (PCOS). PCOS is a common endocrine disorder in young women.~     The pathogenesis behind PCOS is complex and only partly understood, and deeper mechanistic~     insight is needed. Insulin resistance is a central feature of PCOS, and recent studies have~     suggested that this is linked to aberrant adipose tissue function. Exercise training has been~     found to improve the symptoms in PCOS, but we need more knowledge about why. While processes~     involved in skeletal muscle oxidative remodeling are well described, it is to a large extent~     unknown whether the oxidative capacity of human adipose tissue is modified by endurance~     training. The women included in this study will be matched (for body mass index, body weight,~     and age) to participants in another study. This will enable the investigators to do a~     comparison between cases (women with PCOS) and controls (women without PCOS) at baseline, and~     to assess the responses to exercise training in adipose tissue.~   "
47644|NCT02943278|"~     In this study we are testing 2 different forms of sleep therapy to help people with insomnia~     and depression. As part of the study, you receive 1 of these 2 sleep therapies. We want to~     see how these sleep therapies help insomnia in people with depression.~   "
47668|NCT02942966|"~     This is a prospective, multi-center, single-arm, non-blinded study designed to investigate~     the safety and efficacy of the Tack Endovascular System in the Mid/Distal Popliteal, Tibial,~     and Peroneal Arteries ranging in diameter from 1.5mm to 4.5mm for the treatment of post~     percutaneous transluminal balloon angioplasty (PTA) dissection(s) requiring repair.~   "
47670|NCT02942940|"~     Background: Telemedicine is increasingly used to overcome distance between patients and~     physicians. Preliminary studies suggest that mobile app follow-up care for ACL reconstruction~     patients is feasible, can avert in-person follow-up care, and is cost-effective.~      Objective: To avert in-person follow-up through the use of a mobile app in the first six~     weeks after surgery.~      Methods: This will be a single-center, prospective randomized controlled trial~      Results: Data to be analyzed from 72 patients.~   "
47645|NCT02943265|"~     Nearly 70% of people living with cancer are complex patients with multiple chronic~     conditions who must deal not only with effects of their cancer but also continuing diseases~     such as diabetes, depression, hypertension, or heart disease. Care coordination strategies~     shown to be effective in improving outcomes for common medical conditions seen in primary~     care include: systematic transitions for patients to and from specialty care; intensive case~     management; and a team-based approach to comprehensive care. Despite an Institute of Medicine~     report suggesting these strategies as potential ways to improve care for cancer survivors,~     their implementation has not yet been evaluated for cancer survivors. Parkland Health and~     Hospital Systems will be implementing care coordinator strategies as part of as quality~     assurance/quality improvement activities, which Aim 2 and Aim 3 (research components) will~     evaluate. This protocol has been organized to reflect this distinction between the aims. The~     investigators expect no more than 1500 patients to be included in these study aims.~   "
47646|NCT02943252|"~     This is a Single-center, Open-label, Single-arm, Phase Ⅱ exploratory clinical trial~     evaluating the efficacy and safety of Apatinib plus S1 for patients with advanced~     (unresectable, locally advanced, recurrent or metastatic) non-squamous head and neck cancer.~   "
47647|NCT02943239|"~     Assess the safety and tolerability of REGN2477 alone and combined with REGN1033 in health~     postmenopausal women.~   "
47648|NCT02943226|"~     The purpose of this research study is to compare two types of catheters used for infusing the~     contrast dye necessary for viewing internal organs during computed tomography (CT) scanning.~     The standard catheter, which has one hole from which contrast dye enters veins, will be~     compared to the Becton Dickinson Nexiva Diffusics System catheter, which has three holes for~     diffusing dye into veins. The purpose of this study is to determine which catheter type gives~     the best image.~   "
47649|NCT02943213|"~     Cycle Pharmaceuticals Ltd. (Cycle) is developing an oral tablet formulation of Chlorpromazine~     Hydrochloride and intends to conduct bioequivalence trials to demonstrate its similarity to~     the RLD.~      The aim of this pilot study is to investigate intrasubject variability in the bioavailability~     of Chlorpromazine Hydrochloride 25 mg sugar coated tablets.~      Cycle aims to demonstrate that Chlorpromazine Hydrochloride has a shallow dose response curve~     and a wide safety margin. This will then allow for the modification of bioequivalence~     acceptance criteria in future pivotal studies which will reduce the number of participants~     required whilst still maintaining assurance of safety and efficacy.~      Pilot Subjects (n): 20 Periods: 2 (2xR) Dosing: Single-dose Strength: 25 mg Test Product: N/A~     Reference: USL PHARMA Chlorpromazine Hydrochloride Analytes (in plasma): Chlorpromazine;~     7-Hydroxychlorpromazine Bioequivalence based on 90% CI (Cmax, AUC): Standard; 80.00 - 125.00%~   "
47650|NCT02943200|"~     The purpose of the study is to determine the prevalence of malocclusion among a group of~     Egyptian children with digit sucking aged 3 to 6 years.~   "
47651|NCT02943187|"~     The purpose of this investigation is to conduct a series of case studies on the impact of a~     novel functional medicine approach to improving cognitive skills, brain structure, and daily~     functioning for participants with Mild Cognitive Impairment (MCI).~   "
47652|NCT02943174|"~     This investigation aims to apply and test the feasibility of an acceptance, mindfulness and~     compassionate-based intervention structured for cancer patients. MIND programme for cancer~     thus comprises 8 weekly group sessions, lasting 1 and a half hour each, run in small groups~     at an Oncology Service at the Coimbra's University Hospital. For each week participants have~     assigned homework (e.g., mindfulness exercises). This programme mainly aims to increase~     participants' physical and psychosocial quality of life, and attenuate depressed mood and~     anxiety. Additionally, this study also intends to explore whether the reduction of depression~     and anxiety symptoms will promote better results in the medical treatments of the~     participants, and influence the course and prognosis of the illness.~   "
47653|NCT02943161|"~     This study will evaluate whether treatment with L-citrulline, which is an amino acid found in~     some foods, can increase levels of L-arginine and thereby restore the concentration of nitric~     oxide (NO) in the airways.~   "
47654|NCT02943148|"~     Several methods have been used to predict adhesions after abdominal operations.~     High-resolution ultrasonography, magnetic resonance imaging and scar healing properties were~     the methods that were evaluated in the English literature for this study. Estimating the~     likelihood of adhesions and related complications after prior surgery and assessing the~     severity of adhesion formation after surgery is not easy. Anticipating adhesions is very~     important to preventing complications by ensuring that the necessary preoperative~     preparations are in place and/or that appropriate cases are referred to a tertiary center.~   "
47655|NCT02943135|"~     Intrauterine device can cause pain and discomfort in several ways: Use of the tenaculum to~     grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions~     including measuring uterine depth, inserting the insertion tube, and removing the tube; and~     placement of the device in the uterus.~   "
47656|NCT02943122|"~     Preeclamptic pregnancy is associated with alterations in the left ventricular structure and~     function and elevation of cardiovascular biomarkers. The alterations are still persistent~     several months after delivery and are more clearly observed in early-onset and severe~     Pre-eclampsia~   "
47657|NCT02943109|"~     A large-scale randomized control trial (RCT) of the impact and use of an inpatient~     tablet-based patient portal embedded in a larger mixed methods study to examine changes in~     patient experiences and outcomes, and subsequent ambulatory patient portal usage.~   "
47669|NCT02942953|"~     The diaphragmatic pacemaker (DP) has proven its utility in replacing mechanical ventilation~     (MV) in patients with chronic spinal cord injury (SCI) and Amyotrophic Lateral Sclerosis~     (ALS), by improving the patients quality of life and reducing morbi-mortality and the~     associated health care costs. The anesthetic management of these patients and the~     particularities of the surgical procedure represent an anesthetic challenge. The objective of~     our study is to analyze the management and the intraoperative complications in the patients~     with DP in our institution.~   "
47696|NCT02942602|"~     1) to test HDL function comprehensively in healthy and diseased individuals; 2) to evaluate~     if this test correlates with cardiovascular risk, independent of traditional risk factors; 3)~     and to differentiate effects of lipid-modifying or antiatherosclerotic drugs on HDL function~     and composition~   "
47658|NCT02943096|"~     The goal of this proposal is to conduct the first pilot study of whether consuming flavanol~     supplements will augment the cognitive and mood benefits of antidepressant medication in~     older adults with Late LifeDepression (LLD). Flavanols represent a specific group of plant~     derived nutrients that are found in cocoa beans, grapes, tea, berries and various other~     fruits and vegetables. The specific flavanols investigated in this study come from cocoa.~     Currently available treatments for LLD (i.e., antidepressant medication) are limited in~     efficacy, especially in individuals who also suffer from cognitive impairment. Recent studies~     performed at Columbia and elsewhere suggest that flavanols may induce beneficial brain~     changes that support cognitive functioning and elevate mood, but their precise clinical~     effects in older adults with combined depression and cognitive impairment remain to be~     evaluated. For this study, the investigators plan to recruit 50 adults aged ≥60 years who~     have Major Depressive Disorder, meet a minimum depressive symptom threshold despite currently~     receiving an adequate trial of an antidepressant, and have a significant cognitive complaints~     without a diagnosis of dementia. Subjects will be randomized to receive 8 weeks of~     augmentation treatment with flavanol capsules (in addition to continuing their~     antidepressant) vs. capsules not containing flavanols. Pre- and post-treatment MRI scanning~     of the brain will be conducted, and comprehensive pre- and post-treatment neuropsychological~     assessment will be performed. Results from this project will allow the investigators to~     evaluate a novel therapeutic approach to LLD, which could have large public health~     ramifications given the prevalence, frequent treatment resistance, and chronicity~     characteristic of LLD.~   "
47659|NCT02943083|"~     The aims of this study are to determine if:~        1. during pregnancy, a progressive muscle relaxation and abdominal touch ritual involving a~          pleasing scent (i.e. a relaxation ritual) can, acutely, reduce maternal stress and~          affect the fetus (in terms of movement, changes in heart rate and heart rate~          variability);~        2. a progressive muscle relaxation and abdominal touch ritual involving a pleasing scent~          (i.e. a relaxation ritual) during pregnancy can have an effect on mitochondria~          functioning in the placenta through reducing maternal stress during pregnancy (based on~          our recent findings (Monk et al, 2016));~        3. the scent will come to function as a conditioned stimulus such that exposure to the~          scent postpartum will induce greater maternal relaxation, which will have an effect on~          the mother-infant interaction and infant physiology;~        4. prenatal maternal exposure to scent combined with abdominal touch will lead to mothers'~          increased likelihood of utilizing infant massage with a lotion of the same scent~          postpartum;~        5. the prenatal ritual and the increased likelihood of engaging in infant massage will lead~          to a maternal perception of greater mother-infant bonding, attachment and parenting~          efficacy, and improved maternal mood;~        6. the prenatal ritual and the increased likelihood of engaging in infant massage will lead~          to improved performance on the conjugate reinforcement paradigm conditioning task~          administered to infants at 4 months of age~   "
47660|NCT02943070|"~     Evaluate the safety and efficacy of the Rezum System for the treatment of BPH~   "
47661|NCT02943057|"~     25 patients who are diagnosed with Cytomegalovirus (CMV) anterior segment infection, either~     uveitis or endotheliitis, will be started on 2% guttae ganciclovir, 1 drop 5 times a day for~     6 weeks.~      Following 6 weeks of continuous application of 2% guttae ganciclovir, patient will be~     reviewed at the clinic within 3 hours following the last application of topical ganciclovir~     and clinical features will be documented for activity assessment. An aqueous sample 0.2ml is~     drawn. 0.1ml will be sent for RT-PCR for CMV viral load and another 0.1ml will be sent for~     ganciclovir drug level by HPLC method.~   "
47662|NCT02943044|"~     The goal of this study is to determine the optical spectroscopy characteristics of tumor in~     patients with head and neck squamous cell carcinoma (HNSCC). HNSCC constitutes over 90% of~     all head and neck cancers. These spectroscopy measurements will be compared with pathological~     diagnosis of tissue biopsies from the same site. These readings will be performed in the~     operating room during routine endoscopy with biopsy and tumor mapping of patients who have a~     suspected squamous cell carcinoma of the head and/or neck. Furthermore, a built in pressure~     sensor will be used to compare biopsy sites with their benign counterparts. If successful,~     the optical measurements could be used to survey for and delineate the extent of malignancies~     in a noninvasive manner. This would be especially helpful for clinic visits where suspicious~     lesions are seen and would otherwise require biopsy for diagnosis. Immediate benefits would~     include patients with unknown primaries in which numerous directed biopsies are obtained from~     multiple head and neck sites.~   "
47663|NCT02943031|"~     This is a prospective cohort study. Patients who meet the inclusion criteria will be enrolled~     in this study. The samples of biliary tract tumors will be collected. Genome sequencing,~     mini-PDX and PDX will be performed according to the requirement of individualized precision~     therapy programs. Suitable drugs will be chose according to drug screening results. OS and~     PFS will be compared with traditional chemotherapy to evaluate the effect of individualized~     precision therapy programs.~   "
47664|NCT02943018|"~     Interobserver variation in measuring the anovaginal distance (AVD) with perineal ultrasound~   "
47665|NCT02943005|"~     The aim of this study is to compare rehabilitation with the wearing of a sling, to~     rehabilitation without any immobilization after an arthroscopic repair of the supraspinatus~     tendon. The goal is to offer to patients a simplified rehabilitation management, with a~     faster recovery, less pain and a quicker return to normal life.~   "
47666|NCT02942992|"~     To develop an intervention specifically targeted for these clients who have the frailty~     syndrome. The Investigators propose to develop an exercise intervention that can reduce~     frailty in older adults to facilitate their ability to age-in-place. The long-term objective~     of this work is to develop a package of interventions that can be administered within the~     existing Medicaid Home and Community Based Services (HCBS) Waiver programs. The specific goal~     of this proposal is to develop a resistance exercise intervention to reduce frailty in older~     adults receiving long term care services in their home through the Illinois Community Care~     Program, a HCBS Waiver Program.~   "
47667|NCT02942979|"~     This study seeks to implement wrap around services for Veterans suffering from co-occurring~     mental illness and substance use and who are homeless. It will compare Implementation as~     Usual of MISSION to Facilitation Implementation of MISSION.~   "
47671|NCT02942927|"~     In an aging population, most seniors suffer from multiple chronic conditions. When the number~     of medications taken is ≥5 (polypharmacy), the burden of taking multiple concurrent~     medications can do more harm than good. Seniors take an average of 7 regular medications and~     studies link polypharmacy with adverse effects on morbidity, function and health service use.~     However, it is not clear to what extent these are reversible if medication burden is reduced.~      This trial will test the effects on medication numbers and patient health outcomes of an~     intervention to polypharmacy. This study will test a program focused on medication reduction~     number and dose. Prioritizing medications according to the patient's preference as reducing~     the dose also reduces the risk of drug side effects.~      Patients, aged over 69 years taking ≥5 medications, will randomly receive the program~     immediately or at 6 months. The program involves information gathering from the patient,~     including systematically seeking patients priorities and preferences medication review with~     the pharmacist and then a consultation with the family doctor. The intervention is focused on~     discontinuing/reducing the dose of medications where possible using a 'pause and monitor'~     framework to assess the need for restart. An electronic program that detects drug adverse~     effects and flags potentially inappropriate medications will be integrated into an electronic~     clinical pathway incorporating monitoring and follow up systems.~      This study will examine effects on patient and health relevant outcome measures as well as~     qualitative research exploring patients' and clinicians' experiences of reducing medication~     burden. The results will be used to determine whether this system can be implemented as part~     of routine preventative care in primary care for older adults.~   "
47672|NCT02942914|"~     This trial is conducted to evaluate the safety of a study drug given by injection under the~     skin to healthy participants and participants with type 2 diabetes. It will also investigate~     how the body processes the study drug and the effect of the study drug on blood sugar levels.~     Information about any side effects and tolerability will be documented. This study is~     approximately 30 days for each participant, not including screening. Screening is required~     within 28 days prior to the start of the study.~   "
47673|NCT02942901|"~     Surgery has been available for the treatment of pulmonary metastases in metastatic colorectal~     cancer and promising overall survival was observed in retrospective studies with selected~     patients. This study investigated whether the preoperative FDG- PET/CT scan influences~     survival in this patient group. Furthermore, we tried to identify other prognostic factors~     associated with overall survival and progression-free survival.~   "
47674|NCT02942888|"~     The purpose of this study is to determine the effects of Niagen (nicotinamide riboside,~     vitamin B3), on NAD levels, brain function including cognition and blood flow in people~     diagnosed with mild cognitive impairment (MCI).~   "
47675|NCT02942875|"~     Our study aims at investigating the effect of intensive mirror therapy on the motor recovery~     of severely impaired paretic arm at subacute stroke.~   "
47676|NCT02942862|"~     Colon cancer is a very common cancer. Prognosis and adjuvant treatment depend on the~     pathological results. Histoprognostic new factors have recently been published by several~     authors, but their validity is still debated.~   "
47677|NCT02942849|"~     Prospective, non-comparative, multi-centre, multi-country, observational post-authorization~     study, to correlate predictive factors with number of oocytes in relation to the gonadotropin~     dose administered using a new r-hFSH product (Bemfola®) for ovarian stimulation and~     GnRH-antagonists for pituitary suppression~   "
47678|NCT02942836|"~     The goal of the proposed study is to test the capability of the CareTaker monitor to extract~     the respiration signature from its acquired signal, and to determine a respiration rate of~     breaths/minute that meets or exceeds the performance levels of its predicate device.~   "
47679|NCT02942823|"~     Obesity and its associated comorbidities are becoming a key and rapidly growing public health~     problem. The cause of obesity is an imbalance between energy intake and energy expenditure in~     favor of the former. Childhood and adolescence are seen as critical time for its development.~     It is therefore crucial to provide both prevention and treatment actions already during~     childhood. The prevention and treatment weight-management programs in children focus on~     improving diet, eating behaviours, psychosocial aspects and increasing physical activity. One~     important basic requirement for any weight-management program is, that both children and~     their families are motivated and ready for change. Video games, including exergames, serious~     games or combined approaches offer additional chances in the treatment and prevention of~     obesity by approaching children in their environment and motivating them to deal with~     life-style topics.~      As children do not decide alone what they eat - but their parents - the involvement of~     parents in the intervention appears to be very important to reach a sustained effect.~      The investigators developed a motion-controlled serious game for children aged between 9 and~     12 years, addressing all the three core areas nutrition, physical activity, and psychosocial~     factors. In addition to the motion control, a tablet is used for knowledge-based and~     cognitive tasks. In comparison to other studies the nutrition part not only deals with the~     food pyramid but also with the energy density of foods and liquids and offers a~     self-reflexive diagnostic tool to analyse daily food intake. Moreover, psychological aspects,~     especially stress and stress-coping strategies are addressed e.g. by relaxation-exercises and~     a reflexion exercise about leisure behaviour. The game consists of two sessions, having each~     a duration of about 35 minutes.~      The aim of the KOP-1 study was to evaluate the game regarding its acceptance and efficacy in~     a cluster-randomized controlled trial in a primary school setting in children aged 9 to 12~     years. The aim of the here presented KOP-2 study is to evaluate the game regarding its~     acceptance and efficacy in a randomized controlled trial in parents of primary school~     children aged 9 to 12 years receiving the KOP-1 intervention. Therefore, 4th grade pupils of~     the same school will be randomly allocated to an intervention and a control group. Both~     groups will play the game within two weeks, whereas the intervention group will take the game~     home on a tablet computer to play it with their parents in between session 1 and 2. At~     baseline, one day after session 2 and at four weeks follow-up, measurements will be performed~     in pupils and the parents of the intervention group. The primary outcomes of the study are~     the gain of knowledge (nutrition, psychosocial aspects) in parents and children, measured by~     a self-constructed questionnaires tailored specifically for the serious game. Secondary~     outcomes are the interaction of pupils and their parents for the intervention group,~     acceptance of the game, changes of nutrition behaviour, physical activity and intentions of~     the children to follow a healthy lifestyle, measured by mostly validated questionnaires.~   "
47680|NCT02942810|"~     This is a Phase 1, open label, single-dose, pharmacokinetic study to be conducted in male and~     female subjects with normal and impaired renal function. The study will be composed of five~     groups of patients with mild (6 patients), moderate (6 patients), severe (6 patients) renal~     impairment, end stage renal disease patients on hemodialysis (6 patients) and their~     respective matched controls in 1:1 ratio (24 healthy subjects with normal renal function).~     The severity of renal impairment will be assessed based on estimated creatinine clearance~     (CLCR) by the Cockcroft-Gault equation~   "
47681|NCT02942797|"~     This is a prospective study of patients diagnosed with chronic obstructive pulmonary disease~     (COPD) with respiratory failure and admitted in West China Hospital during April 2017 to~     March 2019. The following variables will be prospectively studied: age, sex, height, weight,~     respiratory function indicators, arterial blood gas analysis results, biochemical data,~     nutritional risk screening 2002 (NRS 2002) score, short-term and long-term prognostic~     outcomes. The purpose of this study is to assess whether NRS 2002 is a useful prognosis~     predictor in COPD patients with respiratory failure.~   "
47682|NCT02942784|"~     This is a retrospective study of patients diagnosed with chronic obstructive pulmonary~     disease (COPD) with respiratory failure and admitted in West China Hospital during January~     2014 to March 2016 by review of medical records. The following variables will be~     retrospectively studied: age, sex, marriage, height, weight, respiratory rate, PaO2, PaCO2,~     nutritional risk screening 2002 (NRS 2002) score, ALB, short-term and long-term prognostic~     outcomes, and so on. The purpose of this study is to compare the predictive power of three~     widely used nutritional assessment methods (BMI, NRS 2002 and ALB) predicting the prognostic~     outcomes in a cohort of COPD patients with respiratory failure.~   "
47683|NCT02942771|"~     The purpose of this Study is to find out whether an investigational drug is safe and well~     tolerated. MW189 is being studied as a possible short-term treatment for people with~     different types of brain injury. MW189 has previously been given to healthy human volunteers~     as a single dose, and there were no significant problems or bad effects in people who~     received the Study drug. However, before it can be tested in people with brain injury, it is~     important to test MW189 in healthy volunteers when given multiple doses.~   "
47731|NCT02942134|"~     Acute dyspnea after use of non-invasive ventilation (NIV) is a common phenomenon in patients~     with COPD and emphysema. This trial aims to document incidence and severity of augmented~     dyspnea in patients with long term NIV therapy. These findings may help in understanding the~     pathomechanisms that lead to post-NIV dyspnea and thus give way to potential therapy schemes.~   "
47684|NCT02942758|"~     Diagnosis: Acute myeloid leukemia refractory to intensive induction chemotherapy; Age ≥ 60~     years, no upper age limit; Study drug: low-dose azacitidine, pioglitazone, ATRA; Safety~     Run-In Phase; randomized Phase II, open-label~        -  Safety Run-In Phase: Based on a 3 + 3 modified design, the tolerable dose of ATRA for~          the randomized phase II is defined.~        -  Phase II: Experimental Arm: low-dose azacitidine, pioglitazone, ATRA; Standard Arm:~          standard-dose azacitidine; in both arms patients can receive further cycles (with no~          limit to the number given) as long as clinically appropriate~   "
47685|NCT02942745|"~     Areca nut, also known as betel nut, is the fourth most commonly consumed psychoactive~     substance in the world, following only alcohol, nicotine, and caffeine in prevalence of~     consumption. Although betel nut is chewed by approximately 600 million people globally, its~     use is concentrated in South Asia, Southeast Asia, and some Pacific Islands. Betel nut has~     been classified as a Group 1 carcinogen by the International Agency for Research on Cancer.~     Despite the global significance and carcinogenicity of betel nut, there has been very little~     behavioral or psychological research about betel nut chewing, and there has been no~     systematic research on the topic of betel nut cessation interventions. The current~     intervention builds directly upon the National Institutes of Health - National Cancer~     Institute's U54 University of Guam/University of Hawaii Cancer Center Comprehensive~     Partnership to Advance Health Equity. Previous data collected through the partnership suggest~     that betel nut chewers, like smokers, generally want and intend to quit, but do not have~     specific plans of how or when they will quit. In addition, most betel nut chewers in the~     partnership's previous study already have tried to quit on one or more occasions. The~     findings suggest that betel nut chewers could benefit from cessation programs modeled after~     smoking cessation programs. During 2014, partnership investigators conducted a feasibility~     study of the betel nut cessation program. The program was well received and yielded~     surprisingly high rates of self-reported betel nut cessation.~      Specific Aim 1. To test the efficacy of an intensive group-based betel nut cessation program.~      Specific Aim 2. To quantitatively determine the efficacy of the group-based betel nut~     cessation intervention trial using bio-verification.~   "
47686|NCT02942732|"~     The investigators examined the effect of vitamin D supplementation on glucose homeostasis and~     metabolic markers in healthy normal weight and overweight young subjects and healthy~     normal-weight and overweight elderly subjects living in Beirut, Lebanon.~   "
47687|NCT02942719|"~     1. To describe the average labor curve and establish new labor progression standards.~        2. Cesarean section rates: Based on big data, the investigator will introduce the~          international advanced Robson class method and identify the appropriate level of~          cesarean section rate for each type population.~        3. Establishment of Chinese maternal-fetal medical collaboration network and APP to~          promote natural childbirth.~   "
47688|NCT02942706|"~     This study is try to evaluate the effect of cetuximab monotherapy as maintenance treatment,~     versus continuation after 8 courses of induction therapy with cetuximab plus standard~     chemotherapy regimen (FOLFIRI or mFOLFOX6）in metastatic colorectal cancer (mCRC) patients.~     The maintenance treatments are continued until disease progression or untolerated toxicity.~     The aim of this study is to demonstrate that cetuximab monotherapy is non-inferior to~     continuation treatment, in those mCRC patients who responded to induction therapy(SD, PR, or~     CR), and carry biomarker-panels (KRAS, NRAS, BRAF, and PIK3CA) favor EGFR antibody.~   "
47689|NCT02942693|"~     It is a randomized phase II study to determine the efficacy and safety of particle therapy~     with or without apatinib as induction therapy for the treatment of head and neck adenoid~     cystic carcinoma. Participants will be randomized to arm 1: receiving apatinib for 6 weekly~     followed by particle radiotherapy; arm 2: particle radiotherapy alone.~   "
47690|NCT02942680|"~     evaluate the safety of preoperative aspirin therapy when performing bypass surgery in~     conditions of artificial blood circulation~   "
47691|NCT02942667|"~     The primary objective is to collect high quality MRI data (un-processed or processed) from~     participating subjects for Medtronic research purposes.~   "
47692|NCT02942654|"~     This study evaluates a new formulation of LY900014, a drug that lowers blood sugar. It is~     administered by injection under the skin of the abdomen. The study will be conducted in~     healthy people to investigate how quickly and how much LY900014 is absorbed and the effect of~     different doses of LY900014 on blood sugar levels. Side effects and tolerability will be~     documented. The study will last about 6 to 7 weeks for each participant, including screening~     and follow up. Screening is required within 28 days prior to entering the study.~   "
47693|NCT02942641|"~     Objective: Acute urinary retention (AUR) is a common problem in hospitalized patients. Either~     indwelling urethral catheterization or clean intermittent catheterization (CIC) can be the~     choice of treatment. In chronic urinary retention, most physicians prefer CIC to chronic~     indwelling urethral catheter on the basis of the claim that the rate of catheter-associated~     urinary tract infection (CAUTI) is lower.~      Method: The patients were randomized into indwelling urethral catheter and CIC groups. The~     primary outcomes of the study were catheter-associated asymptomatic bacteriuria and CAUTI.~     The secondary outcomes were pain, hematuria, cloudy urine, and quality of life.~   "
47694|NCT02942628|"~     Open label, 6 week randomized, cross-over study to compare the effect of a vegetarian diet to~     a conventional (meat containing) diet based on the Swedish average meat consumption on a~     range of parameters with prognostic importance for cardiovascular disease.The study will be~     conducted in patients diagnosed with ischemic heart disease. We hypothesize that patients~     will benefit from a vegetarian diet as assessed by multiple risk markers for this type of~     disease with a primary focus on changes in oxidized LDL cholesterol.~   "
47695|NCT02942615|"~     Under the modern precise radiotherapy technology, clear the best dose volume limit index and~     the limit value for the primary level prevention of heart injury; clear best follow-up~     interval and measures for heart function of breast cancer patients, to achieve the secondary~     prevention of cardiac injury; explore combined cardiovascular specialist optimal treatment~     strategy for heart injury in the treatment of breast cancer, during the tertiary prevention~     of cardiac injury; put forward rationalization proposal for prevention, treatment and~     follow-up for breast cancer associated with heart injury.~   "
47732|NCT02942121|"~     The purpose of this study is to learn whether it is feasible to use the LifeScience~     Technologies application (LST app) in patients undergoing radical cystectomy with the~     eventual goal to reduce complications and readmissions to the hospital after surgery.~   "
47697|NCT02942589|"~     The purpose of this study is to test whether food intake in response to large portion sizes~     differs between women who have received portion-control training and women who have not~     received such training. In a crossover design, women come to the laboratory on four occasions~     to eat a lunch of seven foods varying in energy density. Across meals, all foods are varied~     in portion size (100%, 125%, 150%, or 175% of baseline amounts). Food and energy intake is~     determined for each meal. Participants are from two groups: women who completed a one-year~     weight-loss trial in which they were trained in portion-control strategies, and women who had~     not received such training (community controls).~   "
47698|NCT02942576|"~     There are insufficient data on the safety and efficacy of edoxaban therapy in subjects with~     AF following catheter ablation. This phase 3b study is designed to evaluate the safety and to~     explore the efficacy of an edoxaban-based antithrombotic regimen versus a VKA-based~     antithrombotic regimen in subjects with AF following catheter ablation. Bleeding is a central~     safety outcome in cardiovascular clinical trials, especially for antithrombotic strategies~     and invasive procedures.~   "
47699|NCT02942563|"~     The concurrent neoadjuvant chemoradiation therapy is standard care for local advanced rectal~     cancer (LARC), however, this regimen may induce sorts of adverse events, and part of them~     even more severer. A number of pilot studies had shown high rate of complete resection after~     neoadjuvant chemotherapy alone, but the results did not increase the ratio of pathological~     complete response (pCR), which was associated with overall survival (OS). Here, the~     investigators adopt the three active cytotoxic agents (Fluorouracil, Oxaliplatin, Irinotecan,~     FOLFOXIRI) as the neoadjuvant chemotherapy regimen to replace the concurrent chemoradiation~     and to improve the ratio of pCR further.~   "
47700|NCT02942550|"~     This study will examine the impact of the peripheral opioid antagonist methylnaltrexone on~     the onset of effect of ticagrelor in morphine treated patients with ST elevation myocardial~     infarction (STEMI). Half of the participants will receive methylnaltrexone, while the other~     half will receive placebo.~   "
47701|NCT02942537|"~     Uterine fibroids are benign tumors that occur most commonly in women of reproductive age.~     Symptoms of uterine fibroids may be heavy menstrual bleeding which may lead to anemia,~     pressure symptoms, bowel symptoms or urinary urgency. In recent years, increasing attention~     has been paid to the study of minimally invasive methods for treatment. Microwave ablation of~     myomas and endometrium has been shown to have good effect and acceptability has been high.~     This study aims to compare the effectiveness, feasibility and acceptability of percutaneous~     Cmicrowave ablation and uterine artery embolization for the treatment of uterine myomas in a~     randomized single blind study.~      Primary outcome~      1. Volume reduction 6 months post treatment (+/- 15 days) compared to pre treatment measured~     as mean volume reduction of the 3 largest fibroids evaluated by magnetic~      Power calculation~      To be able to show a difference between the groups in myoma shrinkage at 6 months of 75% in~     microwave ablation and 50%[11] in the embolization group with a standard deviation of 25%~     with a alpha of 0.05 and a power of 80% we would need 16 women in each group and thus need to~     randomize 32 women.~      In order to compensate for loss to follow-up or drop out a total of 36 women will be~     randomized.~      Patients and investigators will not be blinded. The MRI will be performed and evaluated by a~     blinded radiologist.~      After having signed informed consent but before randomization patients will undergo MRI of~     the uterine fibroids. Patients with a single fibroid measuring more than 6cm will be excluded~     from further participation in the study.~      All women included in the study after MRI examination will fill in a PBAC evaluation[7]~     during the menses preceding treatment. Women will fill a VAS for maximal pain during 1 month~     prior to treatment.~      Microwave ablation will be performed percutaneously using a Covidien Emprint microwave~     ablation system. Embolization will be performed in conscious women with an epidural catheter~     for pain relief.~      At follow up visit 1, 3 months and 6 months post treatment acceptability will be assessed as~     overall satisfaction of treatment on a scale from 1-7 and if the woman would recommend the~     treatment to a friend.~      A new MRI scan will be performed 6 months post treatment (+/-15 days).~   "
47702|NCT02942524|"~     This clinical trial studies how well a checklist tool works in engaging patients in the~     discharge planning process. Engaging patients in the discharge process may increase~     participation in the discharge process and improve discharge outcomes, understanding of care~     after hospitalization, and decrease complications.~   "
47703|NCT02942511|"~     To idetify the factors favoring the use of enteral nutrition would be helpful to select~     preferred patients suitable for enteral nutrition.~   "
47704|NCT02942498|"~     The purpose of this study is to determine vitamin C and vitamin E in combination are~     effective in the treatment of cognitive and behavior disorder in children with fragile X~     syndrome.~   "
47705|NCT02942485|"~     This study investigates the efficacy and safety of rectally administered metronidazole for~     pediatric Giardia lamblia infection, as well as the acceptance of this treatment regimen by~     patients/caregivers. The investigators hypothesize that rectal metronidazole is non-inferior~     to single-dose of oral tinidazole and will cure at least 72% of patients, a well as will be~     tolerated as good as tinidazole.~   "
47706|NCT02942472|"~     Position of the tip of the inner catheter and air bubbles detection (at time,5min~     10min)during embryo transfer influence the pregnancy rate in ICSI cycles .~   "
47707|NCT02942459|"~     The Aim of this National study is to examine whether music therapy can reduce negative~     symptoms and raise Quality of Life for patients suffering from Schizophrenia. It is an~     Randomized Controlled Trial (RCT), double-blinded study with two arms. 120 Participants are~     anticipated. The two Arms consist of 25 weekly hours of Music Therapy by educated Music~     Therapists and time compensated Music Listening by unknown Care Staff Members.~      The Study is a close Cooperation between Aalborg University (The Music Therapy Research~     Clinic) and Aalborg University Hospital,Psychiatry (The Center of Psychosis Research).~   "
47708|NCT02942446|"~     This investigation is designed to evaluate the at-home usability, performance, user~     acceptance and reliability of the headgear with a CPAP mask for a duration of 6 months.~   "
47709|NCT02942433|"~     Introduction: Change Starts at Home (Change) is a multi-component social behavior change~     communication and community engagement strategy designed to prevent intimate partner violence~     (IPV), a significant public health issue in Nepal and throughout the world.~      Methods and analysis: The study uses a concurrent mixed-methods design. The quantitative~     aspect of the evaluation is a pair-matched, repeated cross-sectional 2-armed, single-blinded~     cluster trial (RCT: N=36 clusters, 1440 individuals), comparing a social behavior change~     communication (SBCC) strategy to radio programming alone for its impact on physical and / or~     sexual IPV at the end of programming (12 months' post-baseline) and 6-months post the~     cessation of project activities (24-months post baseline). The qualitative aspects of the~     design include several longitudinal approaches to understand the impact of the intervention~     and examine mechanisms of change including in-depth interviews with participants (N=18~     couples), and focus group discussions with community leaders (N=3 groups), and family members~     of participants (N=12 groups). Treatment effects will be estimated with generalized logistic~     mixed models specified to compare differences in primary outcome from baseline to follow-up,~     and baseline to 24-months post following intention-to-treat principles.~   "
47710|NCT02942420|"~     Subjects on a standard regimen of tiopronin (cystine binding thiol drug; CBTD) plus~     prescribed first-line therapy (i.e. on a hydration, alkali therapy and dietary restriction)~     who are failing therapy will be selected for this trial.~      After completing informed consent, the subject will have Screening consisting of medication~     history and physical examination with vital signs. Samples of blood and urine will be taken~     for clinical laboratory and urinalysis. Patients will undergo a 12-lead ECG test. A history~     of side effects with current CBTD as well as laboratory recordings of abnormalities~     attributable to treatment will also be recorded.~      Subjects will be dosed in a sequential manner, starting with the low dose group (300 mg/day),~     then proceeding to the 600 mg.day dose group.. Safety and tolerability will be monitored~     closely by an Independent Medical Monitor (IMM) and based on the IMM's assessment that it is~     safe to proceed to the higher dose (600 mg/day), subsequent subjects will be enrolled into~     that group. Up to 15 subjects each will be enrolled into either Group A or Group B.~      After 7 days on the assigned bucillamine dose, a 24-hour urine sample will be taken and after~     completing the Day 8 safety visit, subjects will undergo a 7 day washout where no CBTDs will~     be taken. Thereafter, subjects will be allowed to resume their originally prescribed CBTDs~     under Investigator's supervision.~      One week following study drug discontinuation, subjects will return to the clinic for~     follow-up safety assessments.~   "
47711|NCT02942407|"~     This is a prospective, randomized, open-label, blinded end-point evaluation trial. The~     patient population consists of patients on hemodialysis who have atrial fibrillation (AF) and~     end-stage renal disease (ESRD) .~   "
47712|NCT02942394|"~     Primary objective:~      To assess the efficacy of the stents (sinus-Obliquus stent for the common iliac vein, the~     sinus-XL Flex stent or sinus-Venous stent for the external iliac and common femoral veins) by~     evaluating different gradations of patency rates, patient's rating of disease severity and~     quality of life in patients with post-thrombotic syndrome and concomitant common iliac vein~     compression.~      Secondary objective:~      To assess long-term safety of venous stenting~   "
47713|NCT02942381|"~     The investigators study will recruit IgA nephropathy patients with proteinuria range from~     0.75 to 3.5g/d even after three-month treatment by sufficient ACEi/ARB. The patients were~     treated with Hydroxychloroquine 200-400mg/d according to eGFR. The proteinuria will recorded~     every two months and total four months. Then, the drug will be stopped for two months for~     observation of change of proteinuria.~   "
47714|NCT02942368|"~     This pilot study aims to investigate the potential role of transcranial direct current~     stimulation (tDCS) in the treatment of treatment-resistant major depressive disorder (MDD).~     tDCS is a noninvasive brain stimulation technique which has been utilized for the treatment~     of major depression in several studies, both as a primary and adjunctive treatment. The~     treatment will be administered under the supervision of a physician with experience in~     administering the treatment and monitoring for complications. This will be a prospective~     adaptive tDCS stimulation open label research study. Participants will receive 20 minute~     sessions of up to 4 milliamps (mA) transcutaneous electrical stimulation sessions over 4 to 6~     weeks. Building on the theory that greater current dose may be a significant factor in~     determining efficacy, this study aims to determine whether higher tDCS current doses lead to~     greater improvements in depressive symptoms in this population of patients with~     treatment-resistant major depressive disorder.~   "
47715|NCT02942355|"~     This is an open-label, pilot study designed to evaluate the safety and feasibility of~     combining anastrozole and palbociclib in the following two cohorts: Cohort A) as first-line~     therapy and Cohort B) as maintenance therapy after first-line chemotherapy in postmenopausal~     patients with HR-positive, HER2-negative metastatic breast cancer. Pre- and perimenopausal~     women must receive therapy with an LHRH agonist. The LHRH agonist will be by choice for an~     approved LHRH agonist administered according to its respective prescribing information.~     Following informed consent and eligibility check, subjects will be enrolled to either Cohort~     A or Cohort B.~   "
47716|NCT02942342|"~     The primary goal of this study is to determine the prevalence of undiagnosed asymptomatic~     coronary artery disease (CAD) in Kalamazoo and its neighboring areas using Coronary Computed~     Tomography (CCTA) and Coronary Artery Calcium Score (CACS) to assess if asymptomatic CAD is~     widespread enough to warrant implementation of CCTA as a routine screening tool.~     Additionally, this study will use the CCTA results to evaluate several methods of assessing~     CAD risk in the asymptomatic population including Framingham Risk Score (FRS) and Reynold's~     Risk Score, Biomarkers (High sensitivity C-Reactive Protein, Fibrinogen, Vertical Auto~     Profile, oxidized Low Density Lipoprotein (LDL), Apolipoprotein A1 (ApoA1), Apolipoprotein B1~     (ApoB1), Vitamin D, Homocysteine) as well as a large panel of genetic markers of~     atherosclerosis and dyslipidemia.~   "
47717|NCT02942329|"~     The purpose of this study is to observe and preliminary explore the efficacy and safety of~     combination of Apatinib and SHR-1210 regimen in treating advanced hepatocellular carcinoma or~     gastric cancer.~      Apatinib is a small-molecule vascular endothelial growth factors receptor (VEGFR) tyrosine~     kinase inhibitor, similar to vatalanib (PTK787), but with a binding affinity 10 times that of~     vatalanib or sorafenib.~      SHR-1210 is a humanized anti-PD-1 monoclonal antibody.~   "
47718|NCT02942316|"~     In this study, the pupillary dilation reflex is measured as a nociceptive indicator during~     elective abdominal surgery under general anesthesia.~   "
47719|NCT02942303|"~     The purpose of this study is to describe three safe and reproducible techniques for brow~     lifting using botulinum toxin. It will also describe the effect of 2 techniques on the~     eyebrow shape using quantitative, objective measurements and satisfaction scales.~   "
47720|NCT02942290|"~     This is a Phase 1b, open-label, non-randomized, multicenter, dose-finding study evaluating~     venetoclax in combination with azacitidine in subjects with treatment-naïve higher-risk MDS~     comprising a dose-escalation portion and a safety expansion portion.~   "
47733|NCT02942108|"~     The aim of this clinical trial is to investigate and compare the effect of piezoelectric~     surgery on tissue, cellular and molecular level of oral surgical wound healing and~     postoperative outcomes (pain, swelling, trismus) after lower third molar surgery in healthy~     patients~   "
47854|NCT02940535|"~     The management of the poor responder patients is very difficult. Currently, there is no any~     standard treatment for poor responder patients. The study is designed to test a modified~     GnRHa protocol for poor ovarian response, low dose GnRHa early luteal phase down regulation,~     compare with GnRHa ultra-short protocol. This is a randomized controlled trial.~   "
47721|NCT02942277|"~     Background:~      Researchers are looking for new ways to control and eradicate malaria. They want to test~     vaccines to block malaria transmission in adults in Mali. These vaccines work by inducing~     antibodies in a person. The antibody is then taken up with blood by a mosquito that bites the~     person. This blocks parasite development in the mosquito. This stops malaria transmission to~     another person.~      Objective:~      To test the safety, reactogenicity, immunogenicity, and transmission-blocking activity of the~     vaccines Pfs25M-EPA and Pfs230D1M-EPA with AS01 in Malian adults.~      Eligibility:~      Healthy Malians ages 18-50 living in certain areas in Mali who:~      Are not pregnant or breastfeeding~      Are not infected with HIV, Hepatitis B and Hepatitis C~      Do not have evidence of immunodeficiency~      Do not have history of severe allergic reaction or anaphylaxis~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Malaria Comprehension Exam~      Blood and urine tests~      Electrocardiogram (for participants in certain study groups)~      Participants will be randomly assigned to a study group.~      Participants will be monitored for 12-16 months. For the first 7 months, they will have~     between 1 and nine visits a month. The number depends on the month and on what group they are~     in. For the rest of the months, they will have 1 monthly visit.~      Each visit includes a physical exam. Most include blood tests.~      Participants will get 3 doses of a study or comparator vaccine. They get the vaccine through~     an injection in the upper arm. This occurs at their first visit, then 1 month later, and then~     5 months later.~      Participants will be followed for at least 6 months after the last vaccine.~      If participants develop an injection site rash or reaction, photographs may be taken of the~     site.~   "
47722|NCT02942264|"~     Background:~      TG02 is an investigational drug that penetrates the blood-brain barrier and might treat brain~     tumors. Temozolomide (TMZ) is a drug used to treat brain tumors.~      Objective:~      To find out if TG02 is safe, and to find out if it in combination with TMZ is as effective as~     TMZ alone in people with brain tumors.~      Eligibility:~      People ages 18 and older with a brain tumor that has progressed after standard treatment~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Blood and urine tests~      MRI of the brain if they have not had one in 14 days~      Heart test~      Tissue sample from prior surgeries~      Participants will take TG02 plus TMZ by mouth in 28-day cycles.~      Some will take TMZ for 7 days on and 7 days off. Others will take it every day.~      They will all take TG02 three days before Cycle 1, and then on four days during every cycle.~      They will all get treatment to prevent vomiting and diarrhea before and for 24 hours after~     each TG02 dose.~      They will all keep a diary of when they take the drugs and their symptoms.~      Participants will have study visits. These include:~      Physical exam, heart test, quality of life questionnaire, brain MRI, and urine tests every 4~     weeks~      Blood tests every 2 weeks~      Participants will continue treatment until their disease gets worse or they have intolerable~     side effects.~      Participants will also be enrolled in another protocol to test molecular markers for their~     brain tumor.~   "
47723|NCT02942251|"~     Major depressive depression(MDD) is an severe public mental disorders. The purpose of current~     study is using big data analysis based on clinical features and immunochemistry to~     investigate and establish an relapse predict model for patients with first episode MDD.~   "
47724|NCT02942238|"~     To standardize the surgery for advanced right hemi colon cancer with laparoscopy and~     investigate whether extended lymphadenectomy (CME) could improve disease-free survival in~     patients with right colon cancer, compared with D3 radical operation in laparoscopic~     colectomy.~   "
47725|NCT02942225|"~     The purpose of this study is to understand the pathophysiological mechanisms of ADHD,~     especially the metabolomic pathway related to the behavioral/neuropsychological deficits of~     ADHD.~      To identify specific metabolites that show significant differences between ADHD and control~     groups, both liquid chromatography-mass spectrometry and gas chromatography-mass spectrometry~     will be performed. In addition, the behavioral measures include ADHDRS-IV, SNAP-IV, CBCL,~     CGI-ADHD-S, SAICA, and Family APGAR-C. Neuropsychological testing, including CPT and CANTAB,~     will be performed. Conditional logistic regression and partial least squares discriminant~     analysis will be applied to identify significant metabolites for ADHD. Pathway enrichment and~     topology analyses will be conducted to evaluate the regulated pathways.~   "
47726|NCT02942212|"~     In-Depth Interviews:~      The goal of this research study is to learn about ways to help people might have trouble~     understanding health information quit smoking.~      Pilot Study:~      The goal of this research study is to test 2 different approaches, Standard Treatment (ST)~     and Helping Adults with Health Literacy Trouble (HALT) tailored treatment, for helping~     smokers who might have trouble understanding health information with quitting smoking.~   "
47727|NCT02942199|"~     The goal of the MyMOBILE study is to evaluate the feasibility, acceptability, and usability~     of a novel platform that integrates text messaging reminders, secure electronic pill~     organizers, and daily remote brief motivational recovery support visits with a standardized~     protocol for supervised self-administration of buprenorphine via videoconferencing.~   "
47728|NCT02942173|"~     The purpose of this prospective randomized study is to determine whether infusions of~     T-memory cells prevent infections in children with leukemia after allogeneic alpha, beta~     T-cell receptor (TcRab)/CD19-depleted hematopoietic stem cell transplantation (HSCT).~   "
47729|NCT02942160|"~     A Phase 2, Open-Label Extension Study of EN3835 in the Treatment of Edematous Fibrosclerotic~     Panniculopathy (commonly known as Cellulite).~   "
47730|NCT02942147|"~     Objective: The objective of this study is to compare the efficacy of TENS (transcutaneous~     electrical nerve stimulation) therapy with those of the conventional radiofrequency and pulse~     radiofrequency therapies.~      Design: A single-blind randomized controlled trial~      Setting: An outpatient physical therapy and rehabilitation clinic~      Subjects: The study included 60 patients who presented with a complaint of chronic low back~     pain prevailing at least for 3 months and who were diagnosed with facet joint syndrome.~      Interventions: The patients were randomized into 3 groups so that Group 1 (n: 20) patients~     would receive conventional radiofrequency therapy, Group 2 (n: 20) patients conventional TENS~     procedure for 15 days and Group 3 (n: 20) patients pulse radiofrequency therapy.~      Main measures: The patients were assessed before treatment, and at month 1 and 6 for pain~     (visual analogue scale), disability (Oswestry Disability Index), lumbar movements (hand-floor~     distance), functional status (20-meter walking times, 6-min walking distances), quality of~     life (Short Form 36), and depression (Beck Depression Inventory).~   "
47734|NCT02942095|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of ixazomib and erlotinib that can be given to patients with advanced solid~     tumors. The safety of these drugs will also be studied.~      This is an investigational study. Erlotinib is FDA approved and commercially available to~     treat non-small cell lung cancer, but its use in advanced solid cancer is considered~     investigational. Ixazomib is FDA approved. The study doctor can explain how the study drugs~     are designed to work.~      Up to 36 patients will take part in this study. All will be enrolled at MD Anderson.~   "
47735|NCT02942082|"~     Evaluating the effect of a desensitizing agent on post-bleaching hypersensitivity.~   "
47736|NCT02942069|"~     The purpose of this project is to investigate whether the glucose response in type 1 diabetes~     patients measured using Continuous Glucose Monitoring measurement is reproducible in repeated~     standardized test sessions that include physical activity.~   "
47737|NCT02942056|"~     The overall goal of this proposal is to establish the efficacy of cinnamon for the treatment~     of T2DM. Additional aims will assess the effect of cinnamon on cardiovascular risk factors~     and explore novel potential mechanisms of action leading to improved insulin sensitivity.~     Based on previously published animal and human data we have hypothesized that six months~     treatment with Cinnamon cassia supplementation (2.25 grams/day) will improve glycemic control~     and cardio-metabolic risk factors. We believe these benefits may be mediated in part through~     improved insulin mediated capillary recruitment and skeletal muscle vasodilators leading to~     reduced insulin resistance. We will achieve our goal through completion of the following~     aims:~      Aim 1. To demonstrate the efficacy, safety, and tolerability of oral cinnamon use (750 mg~     three times daily) to improve glucose control. The primary outcome will be determined as a~     reduction in hemglobin A1c (HbA1c) level of at least 0.5% compared to placebo.~      Aim 2. To quantify effects of oral cinnamon (vs. placebo) on cardio-metabolic risk factors,~     including: fasting levels of plasma insulin and glucose, homeostatic model assessment of~     insulin resistance (HOMA-IR), lipids (total, VLDL, LDL, HDL cholesterol; triglyceride), free~     fatty acids, as well whole body, abdominal, and visceral adiposity as measured with dual~     energy x-ray absorptiometry (DEXA) imaging.~      Aim 3. In this mechanistic exploratory aim, potential gastrointesitnal effects will be~     assessed as follows: a 3-hour oral glucose tolerance test (OGTT) with blood samples collected~     for insulin, glucose, C-peptide, glucagon, GLP-1, and GIP will be performed separately.~     Additional biochemical markers (ghrelin, PYY, pro-insulin, apo B, adinopectin) will be~     collected as well.~   "
47738|NCT02942043|"~     The purpose of this study is to explore the efficacy and safety of different doses of~     bevacizumab injection in the treatment of malignant pleural effusion in patients with~     advanced non-squamous non-small cell lung cancer.~   "
47739|NCT02942030|"~     Attentional symptoms characterize both ADHD and other mental conditions in children.~      The diagnosis is based on clinical psychiatric evaluation.~      With the expanding knowledge regarding the neurobiological basis in ADHD the investigators~     have learned that attention is not a general property of the whole brain, but involves~     several coordinated networks. This knowledge promoted the scientific community to the stage~     in which scientists can recognize different types of attention domains.~      in the current study, the investigators use computerized battery to separate between the~     different attention abilities and provide specific attentional profile. in this study the~     investigators aim to characterize different attentional profiles in children who are~     diagnosed with ADHD versus children who diagnosed with other mental condition (which are~     common differential diagnoses of ADHD)~   "
47740|NCT02942017|"~     This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of~     the efficacy, safety, and pharmacokinetics of SAGE-547 Injection in up to 100 adult female~     subjects diagnosed with moderate postpartum depression~   "
47741|NCT02942004|"~     This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of~     the efficacy, safety, and pharmacokinetics of two dose levels of SAGE-547 Injection in up to~     120 adult female subjects diagnosed with severe postpartum depression~   "
47742|NCT02941991|"~     The purpose of this study is to evaluate the long term safety and tolerability of hESC-RPE~     cellular therapy in patients with advanced SMD from 1 to 5 years following the surgical~     procedure to implant the hESC-RPE cells.~   "
47743|NCT02941978|"~     The purpose of the study is to investigate the impact of motivational interviewing in the~     adherence of patients with AF to oral anticoagulation (OAC) regimens. Half of the patients~     will be interviewed and guide on the importance of adherence to OAC medication. Patients~     assigned to the intervention group will be contacted at 1 week, 2 months, 6 months and 1 year~     after discharge. Patients in the control group will be contacted at 1 year after discharge.~   "
47744|NCT02941965|"~     This will be a prospective, randomized (1:1 ratio) clinical trial for patients with~     male-factor infertility with or without preimplantation genetic screening (PGS). Qualified~     650 patients are randomized into either of two groups: group A will undergo intracytoplasmic~     sperm injection (ICSI) without PGS (325 cases), Group B will undergo ICSI with PGS (690~     cases). The partners of all participants will receive the same protocol for ovarian~     stimulation and standardized luteal phase support.~      The target population will be patients with male-factor infertility aged between 20 and 50~     years, diagnosed by the ESHER Criteria (oligospermia and asthenspermia). Women with other~     reasons of infertility (eg. anovulation, endometriosis, and premature ovarian failure) are~     excluded.~      The randomization will take place before the oocyte pick-up day by a computer randomization~     system. The pregnancy test results, pregnancy complications, congenital anomalies, neonatal~     complications will be followed up by checking medical records and telephone calls.~   "
47769|NCT02941640|"~     During laparoscopic appendectomy, the base of the appendix is usually secured by an endoloop~     ligature or the stapler. Non-absorbable plastic hem-o-lok clip was shown as an alternative~     technique with which laparoscopic appendectomy was done faster and cheaper than the standard~     techniques. However, biocompatibility of different materials udes in securing the base of~     appendix is different. It was observed that stapler's clips made by titanium caused the~     mildest inflammatory reaction and creation of adhesions. Disadvantages of stapler's are their~     high price.~      Titanium clips made for the use in laparoscopic appendectomy are safe and effective option in~     securing the appendicular stump in laparoscopic appendectomy. They have potential advantages~     over stapler, because they have the same bio compatibility, and their price is lower.~   "
47745|NCT02941952|"~     In high-risk patients, it is now recommended to guide the intraoperative volume replacement~     via the stroke volume.~      Today, the most commonly used technique for estimating the stroke volume is the~     transpulmonary thermodilution and the arterial waveform analysis in the radial artery by~     PICCO®.~      This technique has the disadvantage of being invasive and increasing the time dedicated to~     anesthesia during the surgery.~      The future is the non-invasive monitoring of stroke volume. Thus, Edwards Life Science has~     developed a continuous monitoring technology and non-invasive arterial pressure, cardiac~     output and stroke volume using a digital sensor (ClearSight®). This continuous monitoring of~     blood pressure was validated in cardiothoracic surgery but studies about monitoring cardiac~     output or stroke volume are inconclusive and contradictory.~      The objective of this study is to compare the use of non-invasive monitoring of stroke volume~     by ClearSight® with the transpulmonary thermodilution and the arterial waveform analysis in~     radial artery by PICCO® in abdominal major surgery.~   "
47746|NCT02941939|"~     Hyperbaric oxygen has previously been tested as a possible means for pre-conditioning to~     enhance exercise performance. This study is designed to examine the effects of exercising in~     a hyperbaric chamber for improving fitness when combined with high-intensity training.~   "
47747|NCT02941926|"~     The purpose of this Phase IIIb study is to collect additional safety and efficacy data for~     the combination of ribociclib + letrozole in men and pre/postmenopausal women with HR+HER2-~     advanced breast cancer.~   "
47748|NCT02941913|"~     BACKGROUND: Palonosetron is a second generation serotonin antagonist usually used in a ﬁxed~     dose of 75 mcg for the prophylaxis of postoperative nausea and vomiting. Although there are a~     few trials evaluating bodyweight-adjusted doses of palonosetron, the ideal dose for obese~     patients has not yet been investigated. The aim of this study is to evaluate if the use of~     bodyweight-adjusted doses of palonosetron (1mcg / kg) is more effective than a fixed dose~     (75mcg) on preventing postoperative nausea and vomiting in female patients with a body mass~     index equal to or above 30 kg /m2 whom have undergone breast surgery METHODS: A prospective,~     randomized double-blind trial will be conducted at the National Cancer Institute (INCA -~     HCIII), in Rio de Janeiro, Brazil. Eligible patients are female aged between 18-70 years of~     age with an ASA physical status of one to three, with body mass index equal to or greater~     than 30 kg / m2, scheduled to undergo elective breast surgery. Forty patients will be~     randomized to receive a fix dose of 75 μg of palonosetron (group I - GI) and 40 patients will~     receive a bodyweight-adjusted dose of 1mcg/kg of palonosetron (group II - GII). Patients will~     be assessed over 3 time periods: 0-6 h, 6-26 h and 24-48 h after surgery. After discharge,~     all patients will be contacted by telephone at regular intervals to record the episodes of~     nausea and vomiting as well as analgesic and antiemetic requirements. The primary outcome~     measure will include the number of emetic episodes, the incidence of nausea, the need for~     rescue antiemetics and the analgesic requirement over 48h. The secondary outcome will be to~     evaluate the frequency of polymorphism of the 5-HT3 receptors and their correlation with the~     antiemetic effect and adverse effects.~   "
47749|NCT02941900|"~     The purpose of this study is to learn whether the patient might be interested in skin cancer~     genetic testing, and if so, what kinds of thoughts, feelings, and behaviors might result from~     this testing. Testing for skin cancer risk based on the MC1R gene is not currently used in~     clinical practice; it will be offered in this study for research purposes only.~   "
47750|NCT02941887|"~     This study aimed at correlating global behavior of Down's Syndrome patients to periodontal~     disease status.~   "
47751|NCT02941874|"~     The purpose of this study is on one hand to verify the measurement conformity of the IRAP~     dosage and on the other hand to obtain normal values of the blood IRAP concentration on~     healthy volunteers.~   "
47752|NCT02941861|"~     Objective:~        1. To study the factors that influence the 3- year recurrence of liver carcinoma after~          surgery~        2. To study the related factors affecting recurrence of liver carcinoma after surgery~   "
47753|NCT02941848|"~     The purpose of this study is to evaluate Pharmacokinetic Properties and Safety after~     administration of HCP1306 tablet and Co-administration of HGP0816 tablet, HGP1404 tablet in~     the healthy adults.~   "
47754|NCT02941835|"~     The PROBI is a phase I/II trial assessing the feasibility of preoperative whole breast~     irradiation in female patients with low to intermediate risk breast cancer, who undergo~     breast conserving therapy, including a boost dose of irradiation.~      An additional goal of this study is to assess tumor response to radiotherapy, by imaging~     modalities (PET-CT and MRI) and pathology~   "
47755|NCT02941822|"~     This study will evaluate the safety, tolerability and pharmacodynamics of ambroxol in~     participants with Parkinson Disease. Participants will administer ambroxol at five dose~     levels and will undergo clinical assessments, lumbar punctures, venepuncture, biomarker blood~     analysis and cognitive assessment throughout the course of the study.~   "
47756|NCT02941809|"~     This study evaluates the addition of placebo to the normal treatment course of methadone in~     patients who are undergoing treatment for opioid use disorder. All participants will be~     enrolled in a methadone outpatient treatment program who have been prescribed a daily regimen~     of methadone. Half of the participants will be given a placebo pill (to be taken with the~     methadone), and the other half will be given standard treatment of care.~   "
47757|NCT02941796|"~     To investigate the pharmacokinetic properties and safety after administration of HCP1105 and~     co-administration of HGP0918, HGP0816 in healthy male volunteers~   "
47758|NCT02941783|"~     The objective in this study is collecting post-marketing information on the safety and~     efficacy of Kovaltry under the routine clinical practice.~   "
47770|NCT02941627|"~     The aim of the study is to assess the efficacy and the safety profile of the Neuro Cochlear~     Implant System (CIS) in adults with severe to profound sensorineural hearing disabilities.~   "
47816|NCT02941029|"~     This research study is being done to develop a new test to identify prostate cancer patients~     at highest risk of radiotherapy-related complications. This research study would allow~     monitoring of total tissue damage within 24 hours of radiation exposure in blood samples that~     could give an initial result within a few days that would help clinicians make treatment~     decisions. Detection of unusual tissue damage at this early time, well before symptoms occur,~     could allow doctors to tailor interventions that could include patient therapies that would~     reduce or prevent the problems that occur due to treatment of their cancer.~   "
47759|NCT02941770|"~     The prevalence of pediatric obesity makes this condition a worldwide public health concern.~     Physical Activity (PA) is recognized as having many health benefits, many of them related to~     obesity and its comorbidities. Despite of all the efforts, the majority of the overweight~     children/adolescents still present low levels of PA and high levels of sedentary behaviors.~     Thus, it seems that the greatest challenge is to influence behavior change in order to~     increase PA exposure in this population. PA consultation can be a cost-effective way of~     enhancing PA and improve weight status among overweight children.~      The main objective of this study is to analyze if the inclusion of a PA consultation in a~     multidisciplinary program for the management of adolescent overweight improves body mass~     index (BMI) z-score, PA levels and sedentary behavior outcomes at six and twelve months,~     compared to those attending only the Pediatric and the Dietetic consultations.~      This study was designed as a non-randomized, controlled clinical trial with six months~     duration and follow-up at the 12th month, that will include overweight adolescents (BMI ≥~     p85) aged 12 to 17, attending the Clinic for the first time, and accepted to be enrolled.~     Those with (i) major pathologies (other than obesity or its related comorbidities), (ii)~     inability to perform regular PA, (iii) mental disorders, (iv) smoking habits, (v) under any~     kind of prescription (other than antihypertensives or metformin), or (vi) being involved in~     another weight loss program will be excluded. According to the sample size calculation, we~     expect to recruit 129 participants that will be allocated in three groups by consecutive~     sampling: (i) control group - standard care (Pediatric and Dietitian consultations); (ii)~     intervention group I - standard care plus PA consultation; (iii) intervention group II - 2~     weekly exercise sessions additionally to the standard care and PA consultations..~   "
47760|NCT02941757|"~     The purpose of this study is to modify the food culture of the fire service by motivating~     firefighters and their families to incorporate Mediterranean diet principles at work and home~     through behavior change strategies that involve education, participation and incentives. The~     ultimate purpose is to lower firefighters' risks for CVD and cancer by successfully getting~     more firefighters and their families to adopt and incorporate the healthy eating principles~     behind the Mediterranean diet.~   "
47761|NCT02941744|"~     Nivolumab (OpdivoTM, BMS), a human IgG-4 anti-PD-1 monoclonal antibody has demonstrated~     anti-tumor activity in patients with advanced melanoma.~      The investigators postulate that patients with melanoma nivolumab have a comparable tumor~     response rate at a dose range of 0.1 to 10 mg/kg q2wks.~      Ipilimumab (YervoyTM, BMS), a human IgG-1 anti-CTLA-4 monoclonal antibody improves the~     survival of patients with advanced melanoma. Adjuvant therapy with ipilimumab improves the~     relapse-free survival after complete resection of high-risk stage III melanoma (EORTC 18071).~      Combined treatment with ipilimumab plus nivolumab improves the tumor response rate and~     overall survival of patients with advanced melanoma but is associated with a higher incidence~     of immune related adverse events (CheckMate 067).Nivolumab and ipilimumab have distinct~     immunological mechanisms that can be revealed by analyzing TCR usage in blood lymphocytes.~   "
47762|NCT02941731|"~     The purpose of this study is to investigate the bioequivalence after administration of~     HIP1403 and HGP0919 suspensions in healthy male volunteers.~   "
47763|NCT02941718|"~     Most treatment-seeking smokers will fail in their attempts to quit smoking in the early days~     and weeks of quitting. Poor sleep (e.g., short duration) is an overlooked, but important~     nicotine withdrawal symptom that can affect up to 80% of treatment seeking smokers and~     predicts relapse. Addressing sleep deficits could promote cessation, particularly in smokers~     who may be vulnerable to poor sleep in one or more sleep metrics even before quitting. This~     study will address this conceptual and empirical gap by conducting a 15-week proof-of-concept~     study to determine whether standard smoking cessation treatment can be optimized with a~     multi-metric sleep advancement counseling intervention.~   "
47764|NCT02941705|"~     Perform a randomized, double blind, placebo-controlled Phase 2a feasibility study to~     determine whether treatment of HFPEF patients with intracoronary allogeneic CDCs affects~     clinical functional status (QOL scores), exercise tolerance (6MHW), exercise hemodynamics~     (supine exercise ergometry during right heart catheterization), myocardial interstitial~     fibrosis (MRI with native T1 mapping and calculation of extracellular volume [ECV] after~     gadolinium administration), macroscopic fibrosis by delayed gadolinium enhancement (DGE), and~     diastolic function (catheterization, echocardiography, BNP).~      Treatment of patients with symptomatic hypertensive heart disease-induced HFPEF with~     allogeneic CDCs will be safe and will improve clinical functional status, exercise~     tolerance/hemodynamics, myocardial interstitial structure, and diastolic function; the~     mechanisms underlying these improvements will be reflected in changes in plasma biomarkers~     that indicate a reduction in pro-inflammatory and pro-fibrotic signaling.~   "
47765|NCT02941692|"~     Oxytocin is a promising new medication found to have positive effects on prosocial behavior,~     reduce negative affect such as fear and anxiety, and reduce stress-induced addictive~     behaviors. This study aims to investigate the extent to which a 40 IU dose of intranasal~     oxytocin improves couples' conflict resolution skills and subjective, physiological, and~     neuroendocrine responses to conflict. Conflict resolution discussions will take place in the~     laboratory and will be videotaped.~   "
47766|NCT02941679|"~     A phase 3 study to evaluate efficacy and safety of HCP1202~   "
47767|NCT02941666|"~     Previous studies have shown an increase in the concentration of mesenchymal stem cells~     (MSC's) in the setting of osteoarthritis of the knee and its correlation to severity.~     Researchers have shown that as there is an increase in the severity of the disease, the~     concentration of stem cells also increases. The purpose of this study is to determine if~     there is the same increase in stem cell concentration in patients with osteonecrosis (ON) of~     the femoral head.~   "
47768|NCT02941653|"~     Objectives: This study will determine the effectiveness of the use of desensitivity gels~     prior in office bleaching on risk and intensity of tooth sensitivity caused by in-office~     bleaching using 35% hydrogen peroxide. Materials and Methods: Fourty seven patients will be~     selected for this triple-blind, randomized, cross-over, placebo-controlled clinical trial. 10~     minutes prior to bleaching procedure, patients will receive the the potassium nitrate 2% and~     potassium oxalate 5% desensitivity gel application on vestibular surface. The whitening~     treatment with 35% hydrogen peroxide will be carried out in two sessions with a 7-day~     interval. Tooth sensitivity will be assessed before, during and 24 hours after the procedure~     using analog visual and verbal scales. Color alteration will be assessed by a bleach guide~     scale and Vita Easy shade spectrophotometer 7 days after each session. Relative risk to~     sensitivity will be calculated and adjusted by session; while comparison of overall risk will~     performed by McNemar's test. Data on the sensitivity level for both scales and color shade~     will be subjected to the Friedman, Wilcoxon and Mann-Whitney tests, respectively (α = 0.05).~   "
47797|NCT02941276|"~     This trial is looking at using an intra-oral electrostimulating device for the management of~     radiotherapy-induced dry mouth.~   "
47771|NCT02941614|"~     Many breast cancer patients experience psychological distress during their cancer care~     journey. There are effective treatments for breast cancer patients experiencing distress,~     such as individual or group therapy, health education, and medication. Unfortunately,~     clinicians may not be aware of the symptoms of distress in their breast cancer patients, and~     some breast cancer patients who could benefit from referral to behavioral health specialists~     are overlooked. New guidelines recommend that all cancer patients be regularly screened for~     distress. However, there are unanswered questions about the impact of distress screening~     conducted on such a large scale. Few studies have evaluated the impact of distress screening~     on important outcomes in breast cancer patients, such as patient experience, symptom~     management, and use of health care services, as compared to the usual care offered by the~     health care organization. In addition, oncology clinicians are uncertain about the benefits~     of large-scale distress screening, and pilot screening programs have not been uniformly~     successful, particularly in the community oncology setting.~      The overarching goals of this study are to assess the effectiveness of implementing a~     guideline-recommended distress screening program for newly diagnosed breast cancer patients~     on improving identification and referral to treatment for highly distressed breast cancer~     patients, to assess patient-reported outcomes, health services utilization, and~     implementation outcomes of the program. This study will address two main research questions:~     1) Is a community-oncology based, large-scale distress screening program more effective than~     usual care on improved identification of distressed patients, referral to behavioral health~     services, and patient-reported outcomes for breast cancer patients? 2) What are the barriers,~     facilitators, and other implementation-related outcomes related to distress screening in the~     community oncology setting?~   "
47772|NCT02941601|"~     The main purpose of this study is to evaluate the effectiveness and safety of~     gemcitabine-carboplatin plus necitumumab in chemotherapy-naïve participants with locally~     advanced or metastatic squamous non-small cell lung cancer.~   "
47773|NCT02941588|"~     Recent guidelines of the ACC/AHA suggest that elective non-cardiac surgery (NCS) should~     optimally be delayed one year after percutaneous coronary intervention (PCI) with~     drug-eluting stent (DES). Regarding the antiplatelet agents, dual antiplatelet therapy, or at~     least aspirin is recommended to be continued considering the relative risk of bleeding and~     stent thrombosis especially during the first 4 to 6 weeks after DES implantation. However,~     these recommendations are based upon insufficient and conflicting evidences.~   "
47774|NCT02941575|"~     In patients receiving implants in the esthetic zone, would the use of new Nano hybrid ceramic~     crown material (Crystal Ultra) improve esthetic patient satisfaction and peri-implant tissue~     success when compared with Lithium Disilicate crown (E-max)?~   "
47775|NCT02941562|"~     The study is designed to analyze the pathological tumor response on locally advanced rectal~     cancer after preoperative treatment with neo-adjuvant therapy regimen or with chemotherapy~     combined with short-course radiotherapy in a prospective cohort and to correlate this~     response with patient's outcome~   "
47776|NCT02941549|"~     The purpose of this randomised, double-blind, placebo-controlled, parallel group study is to~     assess the safety and efficacy of orally administered DS102 capsules versus placebo in the~     treatment of adult patients with Non Alcoholic Fatty Liver Disease (NAFLD)~   "
47777|NCT02941536|"~     This study assesses the number of CTCs before and 4-5 weeks after focal stereotactic~     radiotherapy, in single or fractionated dose, and correlate with the local and distant brain~     progression-free survival in patients with metastatic breast cancer.~   "
47778|NCT02941523|"~     The study evaluates the safety and activity of NOX66 in patients with refractory solid tumors~     that are non responsive to standard therapies.~      This is a two part with a potential third part, open-label, multicenter, dose escalation~     study of NOX66 as monotherapy and in combination with carboplatin.~   "
47779|NCT02941510|"~     A randomized, double-blinded study administering budesonide, a medication to reduce~     inflammation in the lungs, to healthy volunteers to examine effects on altitude illness~     prevention by spending 18 hours overnight at 14,000 ft elevation.~   "
47780|NCT02941497|"~     This program is a non-diet approach to obesity prevention for older adolescents which does~     not promote following a special diet to manage weight; instead, it promotes healthy behavior~     associated with obesity prevention. This approach is especially important with youth and~     older adolescent populations so as to avoid impairment in emotional well-being associated~     with body dissatisfaction. Healthy weight status will be achieved by improving dietary intake~     patterns, increasing physical activity, and improving stress management.~      Fall of year 01 was devoted to the recruitment of student partners (intense intervention~     group) and the development of partnerships. In the spring of year 01, recruited students were~     enrolled in two newly developed undergraduate courses across four intervention state~     partners, became collegiate 4-H members, planned a social marketing campaign, and/or learned~     to be peer mentors or student researchers. In year 02, first year college students were~     recruited, peer mentors were matched with a group of first year students, and the developed~     social marketing campaign was pilot tested on four college campuses (diffuse intervention) by~     the collegiate 4-H teams. In year 02, a toolkit with 24 weeks of intervention activities was~     also refined. In year 03, the collegiate 4-H team (intense intervention group) will use the~     refined toolkit to test and implement the intervention on college campuses. In year 03, the~     assessment process for high school 4-H students (intense intervention group) will be pilot~     tested and college students will work with the high school students on adapting the toolkit~     for use in the implementation of the social marketing campaign in high school settings in~     year 04 (diffuse intervention). In year 04, the college tool kit will be disseminated to~     additional college campuses. In year 05, the program will be disseminated to additional high~     schools.~      The nine month interactive, social marketing environmental intervention will aid older~     adolescents in effectively managing weight through increasing healthfulness of diet,~     increased physical activity, and improved stress management behavior as compared to a control~     group. On all measures it is anticipated that participants in the intensive intervention~     group will have greater improvements than those in the diffuse intervention group and both~     intensive and diffuse intervention groups will have improvements over those in the control~     groups.~   "
47781|NCT02941484|"~     Early oral intake after Pancreaticoduodenectomy is recommended strongly according to the ERAS~     guideline, which was based on studies in patients with gastrointestinal cancer, mainly~     colorectal and gastric. Specific clinical study on early oral intake after PD is very~     limited. inadequate nutritional intake was significantly associated with a high incidence of~     postoperative complications. Therefore, the present study is aim to evaluate the tolerance,~     safety, and efficacy in the patients undergoing PD in the age of ERAS.~   "
47782|NCT02941471|"~     Several transabdominal electrical stimulation studies have been reported for constipation in~     childhood. This study aims to assess the efficacy of this technique in adults with chronic~     constipation and compare two different electrical therapies.~   "
47783|NCT02941458|"~     The GECP, in its commitment to improve the treatment and prognosis of patients with lung~     cancer and other thoracic tumors, has marked the individualization of treatment according to~     the expression of markers predictive of response to chemotherapeutic agents and molecular~     inhibitors of cell proliferation as one of its primary objectives. This could significantly~     improve the prognosis of patients with lung cancer, and will lead to a radical change in~     routine clinical practice. The aim of the register is to explore all data available of all~     patients treated because of thoracic tumours.~   "
47815|NCT02941042|"~     Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses of~     NNC9204-1177 in Subjects being Overweight or with Obesity~   "
47817|NCT02941016|"~     This study aim to detect change in vascular inflammation following intense lipid lowering~     therapy~   "
47818|NCT02941003|"~     The purpose of this study is:~        1. To establish a set of diagnostic criteria of intraoperative frozen section of early~          stage lung adenocarcinoma, including clinicopathologic and molecular characteristics.~        2. To assess its clinical usefulness in guiding surgical procedure for early stage lung~          adenocarcinoma.~   "
47784|NCT02941445|"~     Weight reduction is the most important treatment target in obese women with polycystic ovary~     syndrome (PCOS), yet it is usually hardly achievable with lifestyle intervention alone.~     Glucagon-like peptide 1 (GLP-1) receptor agonist (RA) liraglutide was recently approved as an~     anti-obesity drug but with some limitations, which include high cost and the lack of~     long-term efficacy and safety data regarding weight reduction. In addition, weight loss~     achieved with liraglutide is often non-sustainable after treatment cessation. Although DPP-4~     inhibitors are weight neutral, they reduced weight regain in animals previously treated with~     GLP-1 RAs if they were switched to DPP-4 inhibitor rather than placebo. The aim is to~     evaluate whether DPP-4 inhibitor sitagliptin in combination with metformin reduce body weight~     regain more effectively than metformin alone in obese PCOS who had been previously treated~     with liraglutide.~   "
47785|NCT02941432|"~     Facial eczema and perioral dermatitis are clinical entities that develop exclusively in the~     face and present a special therapeutic challenge. Topical corticosteroids that are commonly~     applied to treat eczema/dermatitis at other body sites are best avoided in the face, as they~     may result in rapid atrophy of facial skin and in the long term rather aggravate facial~     dermatoses. Black tea compresses have been successfully used by German-speaking~     dermatologists to treat facial eczema/dermatitis for decades. The precise mechanism of action~     is unknown but is presumably based on astringent properties of tannins in the black tea and~     on the antiinflammatory action of a wet compress as such. This therapy is cheap, universally~     available and practically free of side-effects. Despite these perceived advantages the~     effects and tolerance of black tea compresses have not been formally studied to date.~     Therefore, the investigators plan to treat 25 patients with facial eczema/perioral dermatitis~     over a period of 6 days each within the current trial. The disease activity will be assessed~     before, during and after completion of treatment using several clinical scores. In addition,~     side-effects, if any, will be documented.~   "
47786|NCT02941419|"~     Induction of autologous angiogenesis in patients with critical limb ischemia using platelet~     lysate.~   "
47787|NCT02941406|"~     The aim of the present study is to investigate the reproducibility of the MP3 and to compare~     the results with conventional perimetry using the Octopus 101 in healthy subjects and~     patients with macular disease.~   "
47788|NCT02941393|"~     In this study, parturients will be randomized to either internal or external tocodynamometry~     contractions' follow up. Investigators recruit primiparous, those who try to have vaginal~     birth after cesarean section and multiparous, who need oxytocin during labor. Primary~     endpoint is the number of operative labors in each group. Secondary endpoints are the~     duration of labor, the use of oxytocin and the condition of the newborn.~   "
47789|NCT02941380|"~     Purpose:~      The purpose of this study is to examine cerebral oxidative and inflammatory stress and~     cerebral hemodynamics during and after coronary artery bypass grafting and correlate with~     postoperative cognitive function.~   "
47790|NCT02941367|"~     Primary Objective:~      To compare the safety, in terms of percentage of patients with symptomatic documented~     hypoglycemia during Ramadan fast, of lixisenatide versus sulfonylurea (SU).~      Secondary Objectives:~        -  To assess effect of lixisenatide versus SU on:~        -  Changes in glycemic control;~        -  Changes in body weight.~        -  To assess overall safety of lixisenatide and SU.~   "
47791|NCT02941354|"~     This trial is conducted globally. The aim of this trial is evaluating the pharmacokinetics~     (the exposure of the trial drug in the body) of NovoEight® (turoctocog alfa) in relation to~     BMI (body mass index) in subjects with haemophilia A.~   "
47792|NCT02941341|"~     Non-comparative, observational, ambispective post-authorisation study (EPA-SP).~   "
47793|NCT02941328|"~     A trial investigating the effects of pyridostigmine (mestinon) versus a placebo in a~     double-blind cross over trial in patients with hereditary proximal spinal muscular atrophy~     (SMA) types 2, 3 and 4.~   "
47794|NCT02941315|"~     The investigators aimed to use CMR technique in helping diagnose the etiology of unknown~     cardiomyopathy. Try to make a risk stratification of susceptible heart failure based on the~     extent of myocardial impairment.~   "
47795|NCT02941302|"~     Knowledge of the spatial extent of gliomas is an essential prerequisite for the treatment~     planning. In particular, the localization of the border zone between tumor infiltrated and~     normal brain tissue is one of the major problems to be solved before beginning therapy.~     However, it is a well known problem that, in conventional magnetic resonance imaging (MRI),~     it often is difficult to detect areas with low tumor infiltration, especially in gliomas,~     because of their infiltrative and often diffuse nature.The study has two purpose:I.To~     correlate the imaging border zone with pathological grade of different tumor site following~     surgery in patients with newly diagnosed intracranial gliomas, work out the biological border~     zone, and complete resect the tumor.II.To determine the feasibility of defining the optimal~     target volume for radiation therapy using MR spectroscopy, diffusion, perfusion and~     functional imaging.~   "
47796|NCT02941289|"~     The aim is to understand which components of attentional deployment and selection are~     impaired in AD during searching in realistic scenes on a computer screen (Experiment 1) and~     in a natural setting (Experiment 2).The investigators will also examine how deficits in~     visual exploration may be related to impairments in semantic, long-term memory (LTM) and~     working memory (WM) representations by manipulating the semantic consistency between the~     target and its visual surroundings, and the type of target cue (abstract vs. precise),~     respectively. Perceptual saliency of target and distractor objects will be also manipulated~     in Expt.1, In Expt.2, in order to determine how deficits in visual exploration may be~     involved in the IADL deficits shown by AD patients, participants at each trial will be~     required to search in a natural settings different types of targets and then to perform an~     IADL using five objects, among which one of the searched targets. Measures analysed: for the~     search tasks (Expt. 1 and 2): eye movements in different search phases, accuracy and response~     times; for IADLs tasks (Expt. 2): eye movements during action planning and execution, motor~     efficiency (number and types of action performed), time to terminate the activity. Compared~     to controls, the investigators expect that AD patients will have reduced ability using scene~     semantic LTM in order to locate the objects, greater attentional capture from highly salient~     features and greater search performance impairment when higher WM resources are required~     (abstract target cues). The investigators also expect that their performance at IADLs will be~     less efficient and, in particular, less organized than control, with reduced advantage of eye~     guidance.~   "
47798|NCT02941263|"~     Background:~      Age-related macular degeneration (AMD) affects the macula in the eye. This is the central~     part of the retina. It is needed for sharp, clear vision and activities like reading and~     driving. AMD is the leading cause of vision loss in Americans 60 years of age and older. An~     advanced form of AMD is called geographic atrophy or GA. It happens when light-sensitive~     cells in the macula die so much that central vision decreases.~      Objective:~      To learn more about geographic atrophy associated with age-related macular degeneration.~      Eligibility:~      Adults at least 55 years old with a certain kind of GA. They must be enrolled in study~     08-EI-0102, 08-EI-0169, 08-EI-0043, 12-EI-0042, or 11-EI-0147 but no other studies.~      Design:~      Participants will be screened with medical history, physical exam, and an eye exam.~      Participants will have study visits every 3 months for 15 months, then every 6 months. They~     will be in the study almost 4 years.~      Visits will last about 8 hours. At each visit, participants may have:~      Medical and eye history. Participants will answer questions about their general health and~     eye health. They may answer written questions about how their eye problems affect their life.~      Eye exam and photographs. Eye pressure will be measured and eye movements will be checked.~     Pupils will be dilated with drops. The thickness of the retina will be measured and photos of~     the eye may be taken....~   "
47799|NCT02941250|"~     Evaluate the operation of the Implantable Subcutaneous String Defibrillator (ISSD) system in~     patients who require an Implantable Cardioverter Defibrillator (ICD) using an emulator.~   "
47800|NCT02941237|"~     This study is to test the usability of a new pulse oximeter probe designed for children 0-5~     years.~   "
47801|NCT02941224|"~     The primary objective of the Clinical Investigation is to assess the clinical safety and the~     inhibition of restenosis of the Investigational Device in the treatment of de-novo~     occluded/stenotic or re-occluded/restenotic lesions of the superficial femoral and/or~     popliteal arteries.~      The primary endpoint of the Clinical Investigation is Late Lumen Loss (LLL) of the target~     lesion, as measured by Quantitative Vascular Angiography (QVA) at 6 months post-index~     procedure.~   "
47802|NCT02941211|"~     Evaluation of efficacy and safety of using Aqueduct -100 - Cervical Dilator Device~   "
47803|NCT02941198|"~     To compare two intrauterine systems in order to avoid complications originating from short~     pregnancy interval and undesired pregnancies in the early postpartum period.~   "
47804|NCT02941185|"~     Preterm newborns are born with lower vitamin D stores. Although vitamin D supplementation is~     recommended there is no consensus regarding the adequate dose of supplementation for preterm~     infants.~   "
47805|NCT02941172|"~     This study investigates cannabinoid CB1 receptors in human brown adipose tissue (BAT) and~     other tissues using positron emission tomography (PET) imaging. Subjects will be scanned in~     room temperature conditions and during controlled cold exposure, and the density of CB1~     receptors in BAT and other tissues will be quantified. The investigators hypothesize, that~     cannabinoid signaling is increased in cold conditions, when BAT is metabolically active.~      Understanding the mechanisms of BAT activation and the role of endocannabinoids in humans is~     important and beneficial in fighting against the epidemic of obesity and diabetes.~   "
47806|NCT02941159|"~     The purpose of this study is to assess the safety and tolerability of SF2000SD in adult male~     healthy volunteers~   "
47807|NCT02941146|"~     Evaluate the safety and efficacy of abdominal DualSculpting with CoolAdvantage applicators.~   "
47808|NCT02941133|"~     The purpose of this study is to determine the effectiveness of neural mobilization techniques~     compared to standard care treatment in patients with lumbar radiculitis.~   "
47809|NCT02941120|"~     Retrospective non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in~     patients with full-thickness cartilage defects in the knee joint.~   "
47810|NCT02941107|"~     Australian Indigenous children, particularly those living in remote communities, suffer a~     disproportionately high burden of rotavirus gastroenteritis disease. Despite the introduction~     of rotavirus vaccine into the Northern Territory (NT) Immunisation Schedule in 2006, the rate~     of hospitalization for rotavirus in NT Aboriginal children < 5 years continues to be high,~     and the rate ratio of rotavirus hospitalisations for Indigenous versus non-Indigenous~     children has actually increased. The reasons for sub-optimal vaccine response are not~     completely understood, but both reduced vaccine immune responses and low vaccine coverage are~     likely to be important factors.~      The purpose of this study is to determine if Aboriginal children who receive an additional~     dose of RV1 between the ages of 6 and 12 months, will have an increase anti-rotavirus serum~     IgA seroconversion and decreased medical presentations with gastroenteritis in the first~     three years of life, compared to those who receive placebo.~   "
47811|NCT02941094|"~     Ultrasound guidance has been established as an effective and safe method during insertion of~     internal jugular vein catheter.. Needle visualization during advancement toward the vein has~     a great impact on both safety and success of the procedure. Clinicians have adopted variable~     techniques to increase needle visualization including changing needle- probe relation~     (in-plane vs. out-of-plane), or using specific ultrasound needles The angle between the~     inserting needle and the probe lying on patient skin affects both the distance to the vein~     and the length of the needle part travelling through the us beam~   "
47812|NCT02941081|"~     This study aims to determine whether IHAT is non-inferior to ferrous sulphate at correcting~     iron deficiency and anaemia, and if IHAT does not increase diarrhoea risk in young children~     living in rural and resource-poor areas of the Gambia.~      The study hypothesis is that IHAT will eliminate iron deficiency and improve haemoglobin~     levels in young children without increasing infectious diarrhoea or promoting inflammation in~     the gut.~   "
47813|NCT02941068|"~     This prospective intended to observe the influence of prophylactic and empirical anti-fungal~     treatment on Severe Sepsis patients with perforations. With the consent of patients' legal~     guardian for prophylactic use of antifungal agents, patients were divided into two groups:~     prophylactic group and Empirical group.~   "
47814|NCT02941055|"~     Rheumatoid arthritis (RA) is a chronic inflammatory disease that affects 0.5-1% of the~     population, and where many patients in spite of modern pharmacological treatment fail to~     reach remission. The main goal of the randomized cross-over trial ADIRA (Anti-inflammatory~     Diet In Rheumatoid Arthritis) is to test the hypothesis that a diet intervention will~     decrease disease activity and improve quality of life in patients with established RA.~   "
47821|NCT02940964|"~     Abstract~      Introduction~      Bystander cardiopulmonary resuscitation (CPR) can more than double the patient's chance of~     survival in Out-of-hospital cardiac arrest (OHCA). In Singapore, bystander CPR rate was low.~     Recent studies have proposed and validated the use of popular songs as aids in performing~     CPR. These songs may not be widely known when applied to a different population, and further,~     may lose popularity over time. Count on me Singapore (COMS) is believed to be known to over~     90% of the Singapore population. Pilot data indicated that CPR performed using COMS as a~     mental metronome (COMSCPR) can achieve guideline-compliant rate of chest compression with~     lower fatigue level than CPR guided by the conventional one-and-two-three-and (Standard~     CPR). The investigators hypothesize that COMSCPR is non-inferior to Standard CPR in achieving~     guideline-compliant rate of chest compression.~      Methodology~      The investigators planned a prospective, randomized, crossover non-inferiority trial~     comparing COMS CPR and Standard CPR. 80 eligible volunteers will be recruited from a~     convenience sample of camp personnel from a military training camp. After a 15 minutes~     familiarization session, they will be randomized into two groups (A and B). Group A will~     proceed to perform one cycle (two minutes) of Standard CPR, while group B will proceed to~     perform one cycle of COMS CPR. participants will cross over to perform one cycle of the other~     method of CPR. After completing this second cycle, a survey form will be administered. The~     Laerdal SkillReporter will be used to measure the CPR performed. After a 7-14 days interval,~     participants will be recalled to attend a test scenario. Statistical analysis will be used to~     compare the two arms.~   "
47822|NCT02940951|"~     Older adults living with incurable and advancing life-limiting illness frequently desire to~     spend as much time as possible comfortably at home, rather than in hospital. They often have~     complex problems that not only affect their ability to function, but also their and their~     family caregivers' overall quality of life (QOL). Routine assessment of their perceived~     health care needs and their self-reported QOL is necessary to ensure that patients' and~     family caregivers' concerns are visible to home care clinicians so that they can be~     effectively monitored and addressed. These types of assessments involve asking people to~     respond to questions about their symptoms, their physical, psychological, social and~     existential/spiritual wellbeing, and their experiences with the care provided. Handheld~     electronic information systems are increasingly used and recommended to facilitate such QOL~     assessments. However, there is a need for information about how such systems are best~     translated into practice improvements that ultimately may improve patient- and family-centred~     outcomes.~      This study is about the implementation of an electronic tablet-based innovative health care~     information system, the Quality of life Assessment and Practice Support System (QPSS), into~     routine care provided by home care services for older adults with life-limiting illnesses and~     their family caregivers. Nine home care sites in Canada are participating. At each site the~     investigators will first adapt the QPSS to the local context and develop a plan for its local~     implementation. Then home care staff will be asked to use it in practice and the~     investigators will evaluate the process of using the QPSS and its effect on patient and~     family caregiver quality of life, health, and satisfaction with care as well as the cost~     consequences of its integration into practice. The effect of its use will be studied in a~     randomized trial, which is the part of the study described in this registry. Patients and~     their family caregivers will be randomly assigned to 1) have their home care team use the~     QPSS in their care or 2) not to use it, instead receiving care as usual. The effect of using~     the QPSS will be measured using questionnaires completed by the participating patients and~     family caregivers every two months. If using the QPSS improves quality of life, health, or~     satisfaction with care, the last stage will explore how to scale up use of the QPSS in~     practice and its integration with existing health information systems.~   "
47823|NCT02940938|"~     The purpose of this study is to evaluate the variations of respiratory changes in pulse~     oximeter plethysmographic amplitude (delta POP) according to different contact forces between~     finger and sensor of pulse oximeter. During general anesthesia without surgical stimuli,~     pulse oximeter sensor is applied with serial contact force, from 0 to maximal 1.5N (increased~     by 0.2N) and POP waveform is obtained for 60 seconds. Delta POP will be calculated and~     compared.~   "
47824|NCT02940925|"~     The purpose of this study is to compare the survival and toxicity of TPC (TAXOL, DDP AND~     CAPECITABINE ) VS PF (cisplatin and 5-Fluorouracil) as induction chemotherapy combined with~     concurrent chemoradiotherapy (CCRT) for stage IVa-b nasopharyngeal carcinoma patients in~     endemic area.~   "
47825|NCT02940912|"~     The purpose of the study is to demonstrate that continuous apomorphine treatment during the~     night compared with placebo improves sleep quality in insomniac patient with Parkinson's~     disease.~   "
47826|NCT02940899|"~     Syracuse University Fit Families is designed to increase the activity level and frequency of~     the children through modified activities using adapted equipment and, importantly, to~     increase the families' comfort level in having their children participate in a variety of~     physical activities, including team and individual sports.~   "
47827|NCT02940886|"~     Evaluation of safety and efficacy of iron isomaltoside compared to iron sucrose in subjects~     suffering from IDA~   "
47828|NCT02940873|"~     Insulin treatment for type 1 diabetes inevitably carries risk of hypoglycaemia (low blood~     sugar) which can be severe enough to cause coma, seizure, even death. Being unable to feel~     when blood glucose is falling, a condition called impaired awareness of hypoglycaemia (IAH),~     increases risk of severe hypoglycaemia 6-fold. IAH can be reversed and risk of severe~     hypoglycaemia reduced when people are taught how to adjust their insulin around their~     life-styles through structured education but problematic hypoglycaemia may persist. Many~     people with apparently intractable IAH and recurrent severe hypoglycaemia have thoughts about~     hypoglycaemia that form barriers to their ability to avoid hypoglycaemia. They cannot benefit~     from conventional treatments to reduce hypoglycaemia. The investigators developed the~     Hypoglycaemia Awareness Restoration Programme for people with type 1 diabetes and problematic~     hypoglycaemia despite otherwise optimised self-care (HARPdoc), a novel intervention that~     combines revision of knowledge about hypoglycaemia avoidance with psychological therapies~     that directly address unhelpful health beliefs about hypoglycaemia. HARPdoc is delivered over~     six weeks, by diabetes educators to groups of 6 people. In a pilot study, severe~     hypoglycaemia was greatly reduced in 23 people with very longstanding IAH and recurrent~     severe hypoglycaemia.~      The investigators propose a group-randomised controlled trial of HARPdoc, comparing it to an~     established educational intervention (Blood Glucose Awareness Training, BGAT) which has also~     been shown to reduce severe hypoglycaemia. 96 people with type 1 diabetes and problematic~     hypoglycaemia persisting despite otherwise optimised insulin self-management will be~     recruited into groups which will be randomised to receive either HARPdoc or BGAT, in 4~     centres. The investigators will measure severe hypoglycaemia over two years following~     courses; hypoglycaemia risk and experience; overall diabetes control and quality of life.~   "
47829|NCT02940860|"~     Evaluation of safety and efficacy of iron isomaltoside compared to iron sucrose in subjects~     with IDA and NDD-CKD.~   "
47830|NCT02940847|"~     The axillary brachial plexus block is a technique of locoregional anesthesia indicated in the~     distal upper limb surgery : hand, forearm, the lower third of the arm including the elbow.~     The anesthesia of the posterior and the medial side of the arm requires a selective block of~     the medial brachial cutaneous nerve and the intercostobrachial nerve, for example to improve~     the tolerance of the inflatable tourniquet used by the surgeons. There are two techniques to~     achieve this block : the blind technique (without ultrasound) and the ultrasound-guided~     technique. At the moment, there are no studies which compare these two techniques. So, the~     purpose of this study is to determine the effectiveness of ultrasound-guided technique~     compared to blind technique in medial brachial cutaneous nerve block and intercostobrachial~     nerve block, in the axilla.~   "
47831|NCT02940834|"~     Observational study about prevalence, predictors of sodium imbalance and prognostic~     significance.~   "
47833|NCT02940808|"~     Cognitive control driven by the prefrontal cortex (PFC) of the brain is thought to be~     important for goal-directed control over stimulus-driven processes. EEG-measured spontaneous~     theta/beta ratio (TBR) may potentially be used as an electrophysiological marker for this~     PFC-mediated cognitive control. In the present study the investigators further examine TBR as~     an electrophysiological marker for cognitive control, by administering caffeine to forty~     healthy female participants. After a first training session, participants will visit the lab~     twice in separate weeks, during which they will orally consume one capsule containing 200mg~     of caffeine, and one capsule containing a placebo substance (double-blind and random order of~     administration). EEG will be measured before and after capsule consumption, and cognitive~     control tasks will be administered after capsule consumption. Generally, the investigators~     expect that caffeine will decrease TBR and thereby increase cognitive control. Additionally,~     the investigators expect that individual differences in baseline frontal (reflected by TBR)~     and central dopaminergic (reflected by spontaneously-measured eye-blink rates; EBR) activity~     will moderate the relationship between caffeine and cognitive control. Furthermore, the~     effects of caffeine on specifically hypervigilance for threatening distractors (taking into~     account a possible moderating role of trait anxiety) were examined as a separate research~     question.~   "
47834|NCT02940795|"~     The majority of pregnant women in the United States are either overweight or obese at~     conception with their offspring having greater adiposity at birth, a 2-fold greater risk of~     later obesity and neonatal insulin resistance.~      Conventional wisdom holds that breast-milk composition is uniform; recently our group has~     questioned this. An increase in consumption of dietary sugars including fructose over the~     past 30 years has risen, and this has been associated with chronic metabolic and endocrine~     disorders and phenotypic alterations that promote obesity and diabetes. However, no prior~     studies have examined how maternal increases of sugars/fructose during lactation affects~     breast-milk composition with potential transmission to the infant. The objective of this~     proposal is to comprehensively assess the presence and pharmacokinetics of sugars, including~     fructose in human breast-milk in response to maternal consumption. The central hypothesis is~     that a graded, dose-response relationship be-tween maternal adiposity and sugar~     concentrations in breast-milk exist and that milk fructose concentrations are associated with~     altered body composition in the first months of life. This proposal, guided by compelling~     preliminary data will examine the evidence linking high intakes of milk fructose with altered~     metabolism and early obesity by pursuing two Specific Aims: 1) Test novel relationships~     between breast-milk sugars and changes in infant fat mass and 2) Characterize the~     pharmacokinetics of milk sugars after consuming a 20 oz. cola. These aims are significant~     given the intractability of obesity/diabetes and a potentially identifiable novel target,~     making for a clear but powerful public message to reduce sugary beverage consumption during~     lactation.~   "
47835|NCT02940782|"~     A randomized clinical trial to assess postoperative pain in patients with symptomatic~     irreversible pulpitis after using Reciproc versus One Shape rotary NiTi Systems.~   "
47836|NCT02940769|"~     The primary study objective is to observe/measure the circadian pattern of sleep, Cortisol~     and Melatonin in MDD subjects and Control subjects. We will also assess if controlled~     exposure to light in MDD subjects (post-partum females, non- post-partum females and males)~     will change these parameters using light glasses. In addition to the biological outcome~     measures (sleep, cortisol and melatonin) we will also monitor sleep and depressive symptoms~     in the research subjects for the duration of the protocol.~   "
47837|NCT02940756|"~     The Democratic Republic of the Congo (DRC) is among the countries most affected by malaria in~     Sub-Saharan Africa. Condidering its size and the geographic position, the DRC is meant to~     play a major role in the malaria control in the region. The National Malaria Control program~     recommends artemisinin-based combination treatments (ACTs), in particular~     artesunate-amodiaquine or artemether-lumefrantrine for the treatment of uncomplicated~     malaria. Previous studies indicated that ACTs are still effective, with efficacy above the~     required threshold of 90%. It is required to assess regularly the efficacy of antimalarial~     drugs, in order to ascertain the relevance of treatment guidelines such that, in case of~     increasing failure rates, alternative options can be decided ontime.~      The purpose of this trial is to assess efficacy and safety of artesunate-amodiaquine (ASAQ~     Winthrop®), artemether-lumefantrine (Coartem Dispersible®) and~     dihydro-artemisinin-piperaquine (Eurartesim®) at day 42 in the treatment of uncomplicated~     Plasmodium falciparum malaria in six surveillance sites around DRC.~   "
47838|NCT02940743|"~     The purpose of this randomized clinical trial is to evaluate alternative technology-supported~     behavioral approaches to engaging 42 maintenance hemodialysis (HD) patients with persistent~     hyperphosphatemia in phosphorus binder adherence and dietary phosphorus restriction.~     Participants will be randomized to 1 of 3 intervention groups: (1) Education (Edu); (2) Edu +~     Self-Monitoring (SM); or (3) Edu + SM + Social Cognitive Theory (SCT)-based training program.~   "
47839|NCT02940730|"~     This study will evaluate the pharmacokinetic properties of dalbavancin when administered as~     an intravenous infusion and instilled into the peritoneal space in patients who are~     undergoing peritoneal dialysis. The patients will receive intravenous dalbavancin followed by~     intensive plasma and peritoneal dialyses fluid sampling. Following a washout phase, the~     patients will then receive dalbavancin instilled into their peritoneal space followed by the~     same intensive plasma and peritoneal dialyses fluid sampling.~   "
47840|NCT02940717|"~     Patients need laminate veneer for their teeth usually use Emax CAD as an etchable ceramic.~     Yet fracture may occur so a stronger material is needed. Vita Suprinity is a recent material~     with glass ceramic enriched with zirconia (approx. 10% by weight) that offer practices and~     laboratories a high-strength, zirconia-reinforced lithium silicate ceramic (ZLS) and can be~     used to fabricate laminate veneers but the investigators have to know clinically it is~     fracture resistance, so the investigators are going to have Parallel groups in a randomized~     clinical trial.~   "
47853|NCT02940548|"~     This trial evaluates the effects of Nifedipine GITS and Amlodipine besylate on blood pressure~     rhythm restoration and arterial stiffness in young and middle-aged non-dipper hypertensives.~     Half of participants will receive Nifedipine GITS, half of half will take medicine in the~     morning or at night. While the other half participants will take amlodipine besylate, whom~     will also be assigned taking medicine in the morning or at night. Ambulatory blood pressure~     monitoring and arterial stiffness examination will be performed before and after~     pharmaceutical intervention.~   "
47841|NCT02940704|"~     -  The aim of this study is to assess the postoperative pain and the intake of analgesic~          medication after using Reciproc single-file reciprocating system or One Shape~          single-file continuous rotary system in patients with symptomatic irreversible pulpitis.~        -  Patients will be diagnosed to determine whether they are eligible for the inclusion~          criteria of this study or not. Patients who are eligible will then start their root~          canal treatment on the same visit and to be completed in one visit only. Patients will~          be phone called in order to record the intensity of pain, amount and frequency of~          analgesic intake at 6, 12, 24, 48 and 72 hours after treatment.~   "
47842|NCT02940691|"~     This study is a phase IV, open-label, single arm, multicentre study whose aim is to assess~     whether interferon-free and ribavirin-free Direct Acting Antiviral (DAA) Hepatitis C Virus~     (HCV) therapy with grazoprevir/elbasvir, will be feasible for the treatment of People who~     inject drugs (PWID) with recent injecting drug use and chronic HCV genotype 1 or 4 infection.~   "
47843|NCT02940678|"~     Trauma is one of the top threats to population health globally. A substantial body of~     research has been devoted to the development of clinical prediction models to aid early~     decision making in trauma care. Often these models are applied outside the context in which~     they were originally developed. In contrast, very little research has focused on the effects~     on model performance of such transfers despite the fact that a potential loss in performance~     could have devastating consequences.~      Data from the Swedish trauma registry SweTrau will be used to study the effects on model~     performance of transfers between different contexts within a single conceptually homogenous~     setting. Using logistic regression models for predicting all-cause mortality within 30 days~     of trauma in adult patients will be developed, focusing on systolic blood pressure,~     respiratory rate, and Glasgow coma scale as predictors.~      Four different sets of data sampled from SweTrau will be used to simulate transfer of models~     between high and low volume centres, metropolitan and non-metropolitan centres, multicentre~     and single centre data, and finally between individual centres. Measures of overall~     performance, clinical usefulness, discrimination, calibration, and recalibration will be used~     to quantify the effects on performance of model transfers.~      The study will provide evidence to help clinicians and policy makers in deciding on whether~     it is appropriate to apply models developed in other contexts. For example, the results of~     this study may inform decisions on the development and implementation of models intended to~     be applied on a national or regional level, and ultimately help designing better trauma care~     and improve the outcomes of trauma patients.~   "
47844|NCT02940665|"~     The primary objective of this prospective cohort study is to compare protein intake and~     adequacy between patients receiving Enhanced Recovery After Surgery (ERAS) protocols with~     patients receiving conventional care. The study will also compare energy intakes, gut~     function, and clinical outcomes between groups. The ability of nutritional parameters,~     including preoperative malnutrition risk and postoperative protein intake, to predict length~     of hospital stay will be evaluated.~   "
47845|NCT02940652|"~     The aim of the trial is to obtain and to describe the position of the laryngeal mask during~     elective magnetic resonance imaging in paediatric patient. The radiologic findings will be~     compared to the clinical performance of the laryngeal mask.~   "
47846|NCT02940639|"~     A Real-Life Study to Evaluate Efficacy and Safety of Nivolumab in Patients with Advanced~     Renal Cell Carcinoma after prior therapy.~   "
47847|NCT02940626|"~     The purpose of this study is the prevention of Staphylococcus aureus pneumonia in~     mechanically ventilated subjects heavily colonized with S. aureus. Staphylococcus aureus is a~     human pathogenic bacterium that causes severe infections, including pneumonia and sepsis.~     Hospital-acquired bacterial pneumonia (HABP) caused by S. aureus, including~     ventilator-associated bacterial pneumonia (VABP) in mechanically ventilated subjects, is a~     significant public health threat despite efforts to optimize antibiotic treatment. ASN100 is~     an investigational monoclonal antibody product that targets the toxins produced by S. aureus~     to protect subjects from developing S. aureus pneumonia.~   "
47848|NCT02940613|"~     This study has two aims: 1) to test the validity of an eating disorder symptom checklist~     against an established clinical interview; and 2) to examine whether providing eating~     disorder patients with visual graphs of their symptom frequency in the early sessions of~     active treatment will lead to higher numbers of patients achieving a rapid response (65%~     reduction in symptoms in the first 4 weeks of treatment). Groups where patients receive~     visual graphs of symptom frequency will be compared with groups where patients do not receive~     visual graphs of symptom frequency on rates of rapid response to cognitive behavior treatment~     for eating disorders.~   "
47849|NCT02940600|"~     The purpose of this study is to evaluate the impact of normothermic machine perfusion in~     liver transplantation using grafts of brain death donors older or equal than 70 years~   "
47850|NCT02940587|"~     The aim of this trial is to demonstrate the effectiveness of complete wound healing in a~     prospective, open-label, randomized trial in which venous leg ulcers (VLU)n will be treated~     using Aurix and compared to patients receiving undefined Usual and Customary Care (UCC)~   "
47851|NCT02940574|"~     The current trial aims to explore the neural and behavioral effects of oxytocin in autism~     spectrum disorders (ASD). Oxytocin is a nonapeptide produced by the paraventricular and~     supraoptic nuclei of the hypothalamus and is known to play a pivotal role in a variety of~     complex social behaviors. Initial studies showed that intranasal administration of oxytocin~     can have a positive effect on social functioning in ASD.~      However, future studies are necessary to explore whether and how oxytocin effects neural~     processes in the brain underlying these behavioral improvements. This trial will not only~     measure behavioral enhancements, but will specifically focus on elucidating the associated~     neurophysiological changes by guiding the administration of oxytocin with regular~     neurophysiological assessments.~   "
47852|NCT02940561|"~     To characterize the pharmacokinetic profile of the Test product - Methotrexate Tablets USP,~     2.5 mg of Amneal Pharmaceuticals, compared to that of the corresponding Reference product -~     Methotrexate Tablets USP 2.5 mg manufactured for DAVA Pharmaceuticals, Inc. in patients with~     mild to severe psoriasis or rheumatoid arthritis, who are already on established regimens of~     2.5 mg every 12 hours for three doses per week under fasting conditions, and to assess their~     bioequivalence.~   "
47855|NCT02940522|"~     To demonstrate that a single dose of Makena® delivered SQ via auto-injector has comparable~     bioavailability to a single IM injection of Makena®.~   "
47857|NCT02940496|"~     The goal of this clinical research study is to learn about the safety and tolerability of~     pembrolizumab when given to patients with advanced liver cancer.~      This is an investigational study. Pembrolizumab is not FDA approved or commercially~     available. It is currently being used for research purposes only. The study doctor can~     explain how the study drug is designed to work.~      Up to 15 participants will be enrolled in this study. All will take part at MD Anderson.~   "
47858|NCT02940483|"~     The goal of this clinical research study is to establish the safety of direct administration~     of 5-Azacytidine into the fourth ventricle of the brain or resection cavity in patients with~     recurrent posterior fossa ependymoma.~   "
47859|NCT02940470|"~     The primary objective of this pilot study is to determine the effect of weight loss on a wide~     range of biomarkers associated with risk of breast cancer recurrence in overweight and obese~     breast cancer survivors. We hypothesized that weight loss would result in a statistically~     significant improvement in biomarkers associated with risk of breast cancer recurrence.~   "
47860|NCT02940457|"~     This study investigates the beneficial effects of prefrontal brain stimulation (with~     transcranial direct current stimulation [tDCS]) during working memory training in seniors~     with mild cognitive impairments.The placebo-controlled double blinded study includes 50~     elderly patients which will be randomized into verum or sham tDCS.~   "
47861|NCT02940444|"~     Thromboembolism is an important perioperative complication in major thoracic surgery, even~     though current guidelines have recommended postoperative administration of heparin or LMWH~     for thromboprophylaxis for those high-risk patients, there are still many cases of~     thromboembolism. Therefore, as the guideline itself writes, the investigators believe the~     rational of dose and timing of heparin in thoracic surgery are still not well established.~     Therefore, the investigators aimed to conduct this randomized controlled study to explore the~     safety and efficacy of preoperative Administration of Heparin as Thromboprophylaxis in Major~     Thoracic Surgery.~   "
47862|NCT02940431|"~     The purpose of this study is to look at the effects of active video game play on youth~     physical activity.~   "
47863|NCT02940418|"~     Allogenic adipose derived mesenchymal stem cells will be injected into patients newly~     diagnosed with type 1 Diabetes Mellitus~   "
47864|NCT02940405|"~     The aim of this study to assess effect of ketorolac premedication on the effectiveness of the~     inferior alveolar nerve block, pretreatment and postoperative pain in patients with~     symptomatic irreversible pulpitis.~   "
47865|NCT02940392|"~     Evaluate the effect of the NxThera BPH Rezum System on prostate tissue in subjects suffering~     from LUTS symptoms secondary to benign prostatic hyperplasia (BPH).~   "
47866|NCT02940379|"~     Primary Objective:~      To assess the effect of repeated once-daily oral doses of sotagliflozin on CYP2D6 and CYP3A~     activities using a CYP probe cocktail of metoprolol and midazolam.~      Secondary Objective:~      To assess the clinical and laboratory safety of sotagliflozin coadministered with the~     cocktail probes as compared to that of cocktail probes alone.~   "
47867|NCT02940366|"~     This purpose of this study is to evaluate effect of high-dose Pitavastatin on glucose control~     in patients with metabolic syndrome.~   "
47868|NCT02940353|"~     Prospective, single cohort, multi-center study evaluating the TREFOIL concept for the~     treatment of edentulous or patients with failing mandibular dentition over 5 years. 90~     patients (15 per centre) will be included. The subject population is at least 18 years old,~     in need of an implant restored full prosthesis providing sufficient bone in the~     interforaminal where a fixed restoration on three implants is regarded as an appropriate~     treatment solution. The components are TREFOIL treatment concept (implants and framework).~   "
47869|NCT02940340|"~     Infective endocarditis (IE) is a severe clinical condition with a high in-hospital and 5-year~     mortality. It has a growing incidence, both related to healthcare and possibly to changes in~     prophylaxis recommendations regarding oral procedures. Though not a new disease, several~     aspects in its clinical and laboratory diagnosis remain to be better studied and innovated.~     The evaluation of systemic microvascular disease has proven crucial in the investigation and~     comprehension of pathophysiology of cardiovascular diseases, as well as a tool for early~     diagnosis and prediction of complications. Few studies deal with microcirculation in patients~     with IE, and so far none utilizing speckle contrast imaging and functional capillary density.~     The present study will contribute to the investigation of microcirculatory changes in IE and~     possibly to earlier diagnosis of the condition and/or of its severity and complications. The~     aim of the study is to evaluate the changes in microvascular bed of patients with both acute~     and subacute endocarditis by speckle contrast imaging and skin video-capillaroscopy.~   "
47870|NCT02940327|"~     Respiratory failure in newborns is common and has high rates of death. Where conventional~     intensive care strategies have failed, newborn children are referred to treatment with Extra-~     Corporeal Membrane Oxygenation (ECMO). This involves connecting children via large bore~     cannulas placed in their heart and major blood vessels to an artificial lung that adds oxygen~     to their blood and removes waste gases (carbon dioxide). Although this treatment saves lives,~     it still has some limitations. In particular, severe complications like bleeding, or damage~     to the kidneys can occur. These complications can lead to death in some cases and long-term~     disability in others. Based on ongoing research in adults and children undergoing cardiac~     surgery the investigators have identified a new process that may underlie some of the~     complications observed in ECMO. The investigators have noted that when transfused blood is~     infused in an ECMO circuit, this results in the accelerated release of substances from the~     donor cells that cause organ damage; at least in adults. There are treatments that can~     reverse this process. Before the investigators explore whether these treatments should be~     used in newborn children on ECMO, the investigators must first demonstrate that they can~     measure the complex inflammatory processes that occur in these critically ill children. The~     investigators therefore propose to conduct a feasibility study to identify the practical~     issues and challenges that would need to be overcome in order to perform a successful trial~     in this high-risk population.~   "
47871|NCT02940314|"~     The purpose of this study is to compare the safety and pharmacokinetic characteristics after~     administration of HIP1503 and HGP1103 in healthy male volunteers.~   "
47887|NCT02940106|"~     This randomized pilot study will assess if there is a difference in clinical pregnancies~     using donor oocytes cryopreserved in either a closed or a semi-closed vitrification device.~   "
47872|NCT02940301|"~     This phase II trial studies how well ibrutinib and nivolumab work in treating patients with~     classical Hodgkin lymphoma that has come back or has not responded to treatment. Ibrutinib~     may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~     Monoclonal antibodies, such as nivolumab, may block cancer growth in different ways by~     targeting certain cells. Giving ibrutinib and nivolumab may work better in treating patients~     with classical Hodgkin lymphoma.~   "
47873|NCT02940288|"~     Auricular (ear) acupuncture treatment involves placing filiform needles in the ears at~     particular locations called acupoints. Although the mechanism for acupuncture analgesia is~     still unclear, it is believed ear acupoints work like reflex points that once stimulated with~     penetration by a needle have the ability to relieve pain in a different part of the body.~      The purpose of this study is to explore the safety and effects of auricular acupuncture~     therapy on postoperative analgesic consumption and pain scores immediately following~     laparoscopic surgery.~   "
47874|NCT02940275|"~     This is an observational clinical study, patients with systemic diseases will be enrolled~     according to the inclusion and exclusion criteria. Patients will received the examination of~     sublingual microcirculation by using incident dark field video microscope (Cytocam，Braedius~     Battery Powered Transilluminator). The microcirculation data includes total small vessel~     density, perfused small vessel density, microvascular flow index, and heterogeneity index.~     The patients will be divided into right groups according to their systemic diseases as~     follows: group 1 hypertension (60 patients), group 2 diabetes mellitus (60), group 3~     hypertension and diabetes mellitus (60), group 4 end stage renal disease with hemodialysis~     (60), group 5 kidney transplant recipients (60), group 6 coronary artery disease (60), and~     group 7 peripheral arterial occlusive disease (60).~   "
47875|NCT02940262|"~     This clinical trial studies how well 68Ga-PSMA-11 positron emission tomography (PET)/computed~     tomography (CT) works in detecting prostate cancer that has come back in patients after~     initial therapy. Diagnostic procedures, such as 68Ga-PSMA-11PET/CT, may help doctors detect~     tumors that have come back after initial therapy.~   "
47876|NCT02940249|"~     Postprandial hyperglycaemia can lead to adverse modifications to functional proteins within~     the body and eventually lead to the development of type 2 diabetes. Previous research by this~     group has shown that an apple polyphenol extract reduced hyperglycaemia following a~     high-carbohydrate meal. The aim of this study is to investigate the effects of lower doses of~     the apple extract on postprandial glycaemia, insulinaemia and plasma gastric inhibitory~     polypeptide concentrations following a mixed carbohydrate test meal.~   "
47877|NCT02940236|"~     To assess possible risk of aspiration with pre-operative oral medications taken with sips~     of water (100ml).~   "
47878|NCT02940223|"~     The goal of this clinical research study is to learn about the effects of combining physical~     activity with fish oil to treat fatigue in patients with advanced cancer receiving~     regorafenib.~      This is an investigational study. Fish oil is commercially available for use as a dietary~     supplement. The use of fish oil in combination with physical activity is currently being~     studied. The study doctor can explain how the study supplements are designed to work.~      Up to 96 participants will be enrolled in this study. All will take part at MD Anderson.~   "
47879|NCT02940210|"~     A randomized, single-blind, multi-center, Phase III clinical trial to evaluate the efficacy~     and safety of adhesion barrier Mediclore versus no treatment in patients with total~     thyroidectomy~   "
47880|NCT02940197|"~     Background: Obesity treatment should be individualized since some calorie restricted diet~     doesn't work for some individuals.~      Objective: we assess the effect of two different calorie restriction with MediterrAsian diet~     on weight loss of FTO rs9939609 carriers with overweight.~      Methods: we recruit 80 healthy overweight participants aged 20-45 years that randomly~     allocated in two interventional group [group 1: Mediterrasian diet according to adjusted~     ideal body weight with 500 calories restriction (RD) and group 2: without 500 calories~     restriction (NRD)+ Moderate physical activity]. Anthropometric indices will be assesses for~     all participants weekly for two month. The criteria for weight loss is 250-500 grams weekly.~     Metabolic indices, physical activity and psychologic aspects will be assesses at baseline and~     the end of the intervention. Dietary adherence will be checked by 24hr recalls at day 0, 30~     and 60. At the end of the study, we compare carriers with different alleles (AA+TA and TT) in~     two intervention groups to find out which calorie restriction is appropriate for each~     genotype. Significant p-value is less than 0.05.~   "
47881|NCT02940184|"~     Investigation of the importance of vagal signaling for the glucohomeostatic effects of GLP-1.~     The study will include physiological studies of truncally vagotomized participants and~     matched controls.~   "
47882|NCT02940171|"~     Prognosis of burn patients has improved over the last decades. Early excision of full~     thickness burns is thought to be one of the key factors which have led to prognostic~     improvement. Best timing for burn excision remain uncertain however. In this multicenter~     observational study, we aim at exploring the impact of timing of surgery on outcome in~     severely ill patients using a propensity analysis.~   "
47883|NCT02940158|"~     The purpose of this study is to assess the effects of consuming either 1/2 or 1/4 cup~     servings of lentils on post-prandial blood glucose and insulin as compared to 4 types of~     starchy foods (corn, macaroni, white potato, white rice).~   "
47884|NCT02940145|"~     The main purpose of the present study was to investigate the effects of 12 weeks of~     resistance training (RT) on phase angle (PhA), body composition, inflammatory and oxidative~     stress biomarkers, in older women and to evaluate whether RT induced adaptations on body~     composition, inflammatory and oxidative stress biomarkers are related to healthy adaptations~     in PhA.~   "
47885|NCT02940132|"~     SC10914 is a potent selective PARP-1 and PARP-2 inhibitor. This study aims to determine the~     safety , tolerability , pharmacokinetic/pharmacodynamics profile of increasing doses of~     SC10914 when administered orally to patients with advanced solid tumors. Furthermore, the~     safety and efficacy of SC10914 in patients with advanced solid tumors and negative expression~     of ATM or BRCA1 or BRCA2 mutation will be evaluated in expanded cohorts to establish the~     Recommended Phase 2 Dose(RP2D).~   "
47886|NCT02940119|"~     Pain in the neck and shoulders is a musculoskeletal disorder that affects a significant~     number of individuals.The aim of this study is to evaluate the effects of PBMT (with a device~     that combines low level laser therapy and light emitting diode therapy) in chronic pain~     relief of musculoskeletal origin in the neck and shoulders area.~   "
47888|NCT02940093|"~     The combined analysis of microbiome, immunological parameters and host genetics in patients~     has potential for applying personalized approaches of prevention, diagnostics or therapy in~     the future. However, the acquisition and analysis of these patient characteristics in a~     scientifically sound, technically reliable, cost-effective, practicable and future-oriented~     fashion are a far from trivial task. Therefore the objectives of the study are (i) to~     optimize a sample and data acquisition and analysis pipeline that fulfills these criteria~     (using samples from healthy volunteers); (ii) validate the pipeline in a cohort of children~     undergoing stem cell transplantation, yielding information on host immuno-genetics, gut~     immune function and the human gut microbiome; (iii) deduct the most critical parameters for~     host-microbiome interplay from this complex dataset.~   "
47889|NCT02940080|"~     A randomized, single-blind cross-over clinical nutrition trial will be conducted. The effects~     of yellow-fleshed potatoes and yellow-fleshed potatoes supplemented with anthocyanins~     extracted from purple-fleshed potatoes on healthy men's postprandial glycemia and insulinemia~     will be compared. Additionally, the postprandial metabolism and metabolites, and the~     appearance and metabolism of the flavonoids and their metabolites is studied in plasma, urine~     and feces.~   "
47890|NCT02940067|"~     This is a pilot study to investigate the effect of prehabilitation on patients undergoing~     elective surgery for pancreatic disease.~   "
47891|NCT02940054|"~     Observational prospective study to validate a new index for early diagnosis of Crohn's~     disease (CD)~   "
47892|NCT02940041|"~     Determine the concordance between gynaecological sonography and pelvic MRI for the~     pre-surgical diagnosis of uterine malignant tumors.~   "
47893|NCT02940028|"~     The ICU is a stressful and challenging place for patients and their families. Many family~     members experience anxiety, depression, and posttraumatic stress disorder during and after~     their ICU experience. The investigators are studying post-traumatic growth in this study.~     Post-traumatic growth (PTG) is a set of positive changes that occurs after a challenging or~     difficult life experience. This study investigates the effects of expressive writing on~     positive changes that occur after a difficult experience .PTG will be compared between the~     intervention group receiving the expressive writing intervention and the control group~     (non-expressive or fact based writing).~   "
47894|NCT02940015|"~     Background:~      Scientists want to improve new studies on how the environment, diet, and genetic factors~     affect human health. To do this, they need biological samples and clinical data. They want to~     find better ways to collect, handle, store, and test these samples and data. This could make~     them more useful for research.~      Objective:~      To collect anonymous samples and clinical data from people. To find better ways to collect,~     handle, store, and test them to support health research.~      Eligibility:~      Healthy people ages 18 and older~      Design:~      Participants will complete a screening form by phone or in person. The form could include~     questions about age, race, ethnicity, menopause status, or pregnancy.~      Participants will donate a specific amount of a sample. This could be blood, breast milk,~     cerumen, ear wax, exhaled breath, hair, mucosal or skin cells, nail clippings, saliva, semen,~     stool, or urine.~      Participants may provide an environmental sample such as dust, water, soil, air, or plant~     life.~      Participants may get kits to collect their samples. They may also donate them at a clinic~     visit.~      Visit will take about 30 minutes. They may include:~      Sample collection~      Questions about diet, smoking, alcohol use, medication, menstrual cycle, and health~      Measurement of body composition, naturally occurring radioactivity, or Doppler blood flow~      Moderate exercise~      Flexibility, muscle strength, or sensory testing~      Participants may be asked to participate several times during the study.~   "
47895|NCT02940002|"~     To explore the efficacy and safety of four BAY1003803 formulations by means of a within~     subject comparison in an open Psoriasis Plaque Test~   "
47896|NCT02939989|"~     The purpose of this study is to evaluate the efficacy and safety of co-administration of~     ABT-493/ABT-530 plus sofosbuvir (SOF) plus ribavirin (RBV) in hepatitis C virus (HCV)~     genotype (GT) 1 - 6-infected participants (including non-cirrhotic, or cirrhotic~     participants) who have experienced virologic failure in an AbbVie parent clinical study.~   "
47897|NCT02939976|"~     Patients with partially blocked blood vessel(s) in their heart may need a medical procedure~     called Percutaneous Coronary Intervention (PCI) to open the narrowed blood vessel(s). The~     purpose of this study is to simultaneously address four potential advances in ST-Elevation~     Myocardial Infarction (STEMI) care for patients at least 65 years old. The investigators are~     looking to see if these advances can improve the outcome for these patients.~        1. Opening the arteries with a Medtronic stent~        2. Radial access (from wrist) success with a Medtronic stent~        3. Checking the percent of blockage in the diseased artery/arteries using Volcano guide~          wires.~        4. Reduced bleeding and vascular complications with radial arterial access for primary PCI~          in STEMI.~   "
47898|NCT02939963|"~     Patients who are intubated and mechanically ventilated for acute respiratory failure in the~     Intensive Care Unit (ICU) are at some point eligible for weaning. The common way to wean them~     from mechanical ventilation is to screen criteria for feasibility and, if present, to test~     feasibility by performing spontaneous breathing trial. This latter can be done either by~     setting a low pressure support level (expected to compensate the airflow resistance due to~     endotracheal tube) or by allowing the patient to breathe spontaneously through the tube~     without any support from the ventilator. Combination of low pressure assistance strategy (7~     cm H2O) and positive expiratory pressure (PEP) of 4 cm H2O is the strategy used in our unit.~     Such a low pressure support level should actually result in a real assistance and, hence this~     is not the real spontaneous breathing capacity that is tested. Some ICU ventilators offer the~     option of compensating for the airflow resistance due to endotracheal tube, automatic tube~     compensation (ATC). Therefore, investigators aimed at comparing in patients ready to wean the~     usual procedure in our ICU and the ATC mode. In the ATC arm, the patients are breathing~     spontaneously through the endotracheal tube and are connected to the ventilator set at~     inspiratory pressure support of 0 cm H2O, PEP 4 cm H2O and ATC on.~      Two parallel arms depending on the order of allocation of each mode: pressure support 7 cm~     H2O + PEP 4 cm H2O then ATC or the opposite. The primary endpoint is the power of the work of~     breathing. The hypothesis is that the power of the work of breathing is greater in ATC than~     in the usual procedure, and hence this latter is a real ventilator support.~   "
47899|NCT02939950|"~     The objective of this study is to evaluate the safety and effectiveness of the Bausch + Lomb~     samfilcon A soft (hydrophilic) contact lens, a new silicone hydrogel contact lens, compared~     to the Bausch + Lomb PureVision® contact lens when worn for 7-day extended wear by adapted~     soft contact lens wearers.~   "
47900|NCT02939937|"~     Optic neuritis typically occurs in young (mean age, 32 years), female (77%) patients, and it~     presents as subacute monocular visual loss that develops over several days.~      As yet, treatment with intravenous corticosteroid for optic neuritis had no long-term~     beneficial effect on vision.~      There are a number of factors that contribute to nerve fibre damage including increased level~     of sodium, so blocking sodium entry could help to protect them against damage.~      The main objective of the study is determine whether phenytoin (which blocks sodium entry)~     can protect nerve fibre and improve final visual function after optic neuritis.~   "
47901|NCT02939924|"~     To assess safety and efficacy of the Kanshas DCB in the treatment of de novo lesions in the~     superficial femoral (SFA) and/or popliteal arteries.~   "
47902|NCT02939911|"~     Residual neuromuscular blockade (RNB) is frequent and it is associated with postoperative~     morbidity and mortality. The incidence of the RNB in pediatric anesthesia is currently not~     known. The aim of this prospective observational cohort study is to evaluate the early RNB~     just before extubation and late RNB at the time of arrival to postanesthetic care unit~     (PACU).~   "
47903|NCT02939898|"~     The goal of this project is to identify autocrine, paracrine and endocrine factors which are~     associated with intercycle variation in cyclical follicle recruitment.~      Patients will be monitored in a natural cycle, a stimulated cycle and a follow up. In the~     stimulated cycle patients will be randomized to co-treatment with aromatase inhibitor or~     placebo during ovarian stimulation.~   "
47904|NCT02939885|"~     The purpose of the study is to better define and understand the brain mechanisms related to~     emotional and cognitive dimensions using odorous stimuli, gustatory stimuli, visual stimuli~     and auditory stimuli using functional Magnetic Resonance Imaging (fMRI).~   "
47905|NCT02939872|"~     The purpose of this study is to evaluate optimal duration of antiplatelet therapy after~     Bioresorbable Vascular Scaffold implantation to reduce late coronary arterial thrombotic~     events.~   "
47906|NCT02939859|"~     Purpose of study is to determine safety and efficacy of use of autologous Adipose-Derived~     cellular Stromal Vascular Fraction (AD-cSVF) suspended in Normal Saline and delivered via~     intravascular system of quality of life and alteration of documented Muscular Sclerosis (MS)~     and related neurodegenerative patients. It is believed that the heterogeneous cell population~     which includes multipotent stem/stromal cells are capable of immune modulation/inflammatory~     modulation properties. Exam of disease progression and quality of life changes will be~     evaluated.~   "
47907|NCT02939846|"~     Present clinical study will be conducted in China to evaluate the pharmacokinetics of single~     and repeat oral doses of trametinib, the safety profile and the clinical activity in Chinese~     subjects with solid tumor. Approximately 10 evaluable subjects will be enrolled in the study,~     Subjects will receive trametinib 2 mg once daily (QD). Study treatment will continue until~     disease progression, death or unacceptable toxicity. The study will be completed after all~     subjects have discontinued from study treatment or last enrolled subject has had at least 16~     weeks of follow-up, whichever occurs first.~   "
47908|NCT02939833|"~     Patients undergoing meningeoma resection surgery will be randomly assigned to two groups. One~     group will receive scalp nerve blocks with 0.5% ropivacaine, whereas the other group will~     receive scalp nerve blocks with 0.9% saline after anesthesia induction and before skull-pin~     insertion. Serum levels of TNF-α、IL-6 and IL-1β will be measured and compared at before~     surgery, 1h, 24h and 72h after surgery, respectively. VAS score, dosage of pain-control~     medicine and NRS score at the first three days after surgery, ratio of intracranial infection~     within 30d after surgery, and total hospitalization days and medical expenditure will also be~     recorded and compared between the two groups.~   "
47909|NCT02939820|"~     The purpose of this study is to provide expanded access of patisiran to patients with~     hereditary transthyretin-mediated amyloidosis (hATTR).~   "
47910|NCT02939807|"~     This is a Phase II efficacy study of single agent ABC294640. Patients with advanced~     hepatocellular carcinoma (HCC) who have experienced tumor progression with 1st line single~     agent sorafenib will receive ABC294640 500 mg po bid continuously.~      Patients will continue on therapy until the development of progressive disease per modified~     RECIST, intolerable toxicity, withdrawal of patient consent or other event as outlined in~     patient discontinuation.~   "
47911|NCT02939794|"~     Anemia after cardiac surgery is a vast phenomena. More than 70% of the patients who under~     went surgery represented with hemoglobin less than 8 mg/dl (the cutoff for blood transfusion)~     and more than 80% of the patients receives at least one unit of red blood cell transfusion.~      There were number of attempts to prevent the postoperative anemia by giving erythropoietin,~     Iron per os and intra venus iron. non of the above have shown increase in Hemoglobin after~     the cardiac surgery.~   "
47920|NCT02939677|"~     Anterior cruciate ligament reconstruction (ACLR) is high volume surgery, carried out in about~     2800 patients annually in Denmark per year. ACLR patients (using hamstring auto-graft) have~     persistent hamstring strength deficiency when evaluated more than 1-2 years after~     ACL-reconstruction. The investigators have designed this randomized controlled trial (RCT)~     with the main purpose to investigate the effect of a targeted muscle strength exercise~     intervention on the neuromuscular rehabilitation of ACLR-patients compared with 'care-as-~     usual'.~      The study is designed as a prospective, superiority, parallel-group with balanced~     randomization (1:1) RCT (Level of evidence: II) with blinded allocation, and outcome~     assessment according to the CONSORT statement (Consolidated Standards of Reporting Trials).~     50 patients with ACL reconstruction and persistent hamstring muscle deficiency, will be~     recruited at the outpatient clinic 1-year follow-up, and allocated to one of two 12 weeks'~     interventions, either a) the supervised progressive strength and neuromuscular exercise group~     (SNG) with supervised training twice weekly. Or b) the control group (CON) receiving patient~     education based on a home-based exercise regime of low intensity, defined as 'care as usual'.~     Outcome measures include, maximal isometric knee flexor muscle strength (primary outcome),~     knee extensor strength, and the Knee injury and Osteoarthritis Outcome Score (KOOS)~     (secondary outcomes). In addition, the following explorative outcomes will be investigated;~     hamstring to quadriceps strength ratios, the International Knee Documentation Committee~     Subjective Knee Form (IKDC), magnetic resonance imaging (MRI) to evaluate tendon regeneration~     of the hamstrings and finally kinetic/kinematic biomechanical outcomes of knee related~     functional tasks.~      To the investigators knowledge, this is the first RCT to investigate the efficacy of combined~     progressive resistance training and neuromuscular exercise in the late rehabilitation phase~     in patients demonstrating persistent limb-to-limb knee muscle asymmetry following ACLR.~     Reduced hamstring strength represents a potential risk factor for secondary ligament rupture~     and accelerated progression of osteoarthritis (OA). If deemed effective, the intervention~     paradigm introduced in this study may help to improve current treatment strategies.~   "
47912|NCT02939781|"~     Fever is part of the body's immune response, often triggered by infection. Fever is commonly~     treated with medicines such as paracetamol, mainly because people feel unwell with fever.~     However fever does have a role in fighting infection: it enables the rest of the immune~     system to function more efficiently, and may directly stop bacteria and viruses from~     multiplying. In most cases however treating fever does not matter because the rest of the~     immune system can cope well enough to fight the infection (with or without additional~     treatment, like antibiotics).~      In critically ill patients however any advantage in the fight against infection may be~     crucial. In a large observational study of adult patients in the intensive care unit,~     patients who developed an early fever with temperature between 38.5-39.5 degrees C fared~     relatively better than patients who were colder. So it is possible that in critical illness~     fever may be beneficial. However in critical illness the body does have limited energy~     resources. In order to raise the body temperature energy is required. However the~     investigators do not know how much energy is required to generate a fever in critically ill~     children. This study will aim to try and measure the energy required to generate a fever in a~     critically ill child. The investigators will measure energy expenditure directly in children~     admitted to the intensive care unit by measuring the levels of oxygen and carbon dioxide they~     breathe in and out (a method called indirect calorimetry). This will enable the investigators~     to judge whether the benefits of a fever can be justified by the energy costs in the energy~     depleted state that is critical illness.~   "
47913|NCT02939768|"~     Background: Type 1 diabetes mellitus (T1DM) is characterized by the destruction of β cells~     and consequent loss of insulin secretion due an autoimmune process, being associated with~     increased cardiovascular risk, oxidative stress and inflammation.~      Considering that most people with T1DM do not reach recommended levels of physical activity~     due to concern about the rapid drop in blood sugar and the excuse of lack of time, shorter~     sessions of exercise that provide several benefits should be encouraged. Thus, this work aims~     to compare the effects of high-intensity interval training (HIIT), strength training (ST) and~     both interventions on several blood markers and functional parameters in T1DM patients.~      Study hypothesis: (1) ST+HIIT will be more beneficial than HIIT, which in turn will be more~     beneficial than ST, on modification of blood levels of pro and anti-inflammatory, pro and~     antioxidant, lipid, renal and glucose metabolism parameters and (2) ST+HIIT will be more~     beneficial than HIIT, which in turn will be more beneficial than ST, on modification of~     functional parameters, body composition and maximal oxygen uptake.~   "
47914|NCT02939755|"~     To test the efficacy of a web-based stepped collaborative care intervention to reduce~     symptoms of depression, pain, and fatigue and improve health-related quality of life (HRQL)~     in advanced cancer patients and to reduce stress and depression, and fewer CVD risk factors~     in caregivers.~   "
47915|NCT02939742|"~     The purpose of this study is to determine if a repeat course of betamethasone given to~     pregnant women with preterm premature rupture of membranes (PPROM) will decrease the infant's~     length of stay in the neonatal intensive care unit (NICU) and the overall neonatal morbidity~     associated with this condition.~   "
47916|NCT02939729|"~     The purpose of this study is to determine the effects of a physiotherapy prehabilitation~     programme (walking and deep breathing exercises) in cardiac or thoracic patients by measuring~     changes in lung volumes, functional capacity physiotherapy length of stay postoperatively.~   "
47917|NCT02939716|"~     When patients have bowel surgery they are sometimes left with a stoma, where the small bowel~     exits onto the wall of the abdomen, not into the colon. Certain foods have been shown to~     increase the amount of water lost through a stoma. This can lead to dehydration. Such~     patients are encouraged to avoid such foods but knowing which ones to avoid relies partly on~     trial and error.~      In a survey 1 in 3 patients said that rhubarb increased stoma output. Rhubarb is known to~     contain chemicals that can stimulate the bowel. 1 in 6 patients also reported the same effect~     with lettuce which has not previously been shown to have such an effect. Latex found in~     lettuce leaves may stimulate the bowel to produce more fluid, explaining this effect.~      In Nottingham the investigators have developed techniques that use Magnetic Resonance Imaging~     (MRI) to measure water in the small bowel. They want to use these techniques to explore~     whether eating lettuce increase small bowel water content. They will compare lettuce to~     rhubarb and to bread, which they know reduces small bowel water. They will see if they can~     detect any relationship between water in the bowel and feelings of bloating.~   "
47918|NCT02939703|"~     We propose to study the role of the gut microbiome in the development of obesity, and whether~     we can change the microbiome's contribution to host energy balance through diet. We have~     created a novel model that explicitly links the effects of microorganisms on human energy~     balance and modeled weight change, and will use the power of metabolic ward studies to~     measure small changes in energy absorption, total daily energy expenditure, and/or food~     intake that affect long-term weight gain or loss. By integrating clinical measurements,~     bioreactor experiments, and mathematical modeling, we will be able to describe~     cause-and-effect mechanisms that will enable a quantification of the microbiota's~     contribution to weight gain and inspire future studies on the interactions of diet, the gut~     microbiome, and human physiology.~   "
47919|NCT02939690|"~     In this randomized clinical study, neonates who require umbilical venous catheter (UVC)~     insertion as part of their routine care at anytime during their NICU admission will be~     randomized to one of the 2 formulas for estimation of the pre-insertion UVC depth (umbilicus~     to the nipple in cm minus 1 (UN - 1) or birth weight based formula ([(3× birth weight (Kg) +~     9)/2+1)]. UVC will be inserted under sterile condition as per unit protocol. To verify the~     UVC tip position, a thoracoabdominal radiograph will be taken. In addition, the investigators~     will do a ultrasound of the heart to assess the exact location of the catheter tips as soon~     as possible but within 6 hours of insertion.~   "
47921|NCT02939664|"~     This study try to identify differences in length of operation, weight loss and complications,~     between two different bariatric surgical techniques, the laparoscopic Roux-en-Y gastric~     bypass and the laparoscopic Roux-en-Y banded gastric bypass. The study will be conducted in a~     Spanish public health system hospital. The patients of the trial will have the preoperative~     studies, hospital treatment during the admission, postoperative treatment and follow up as~     any other patient included in the hospital bariatric surgery program. The study cases will~     have placed around the gastric pouch a band of polypropylene mesh, and will be randomly~     choose between the participants.~      Patients will be randomized in a 5/3 (study/control) ratio.~   "
47922|NCT02939651|"~     The purpose of this research study is to test if pembrolizumab is safe and effective for~     treating patients with metastatic high-grade neuroendocrine tumors who have failed platinum~     based chemotherapy.The study drug, pembrolizumab has been FDA approved for treating a type of~     skin cancer called melanoma and for metastatic non-small cell lung cancer. However, it is not~     approved for treatment of metastatic high-grade neuroendocrine tumors.~   "
47923|NCT02939638|"~     This randomized, controlled trial aims to elucidate the mechanisms by which a plant-based~     dietary intervention causes weight loss. Using a low-fat, plant-based diet for 16 weeks,~     along with an untreated control for comparison, the study will measure changes in insulin~     sensitivity, beta-cell function, postprandial metabolism, and intracellular lipid, and assess~     their associations with changes in body weight.~   "
47924|NCT02939625|"~     Asthma is characterized by recurrent episodes of bronchospasm, bronchial hyperresponsiveness~     and chronic airway inflammation and pharmacological treatment for this condition is done with~     bronchodilators and anti-inflammatory.~   "
47925|NCT02939612|"~     The purpose with this study is to test the effect of an app for stress management among~     patients with different cancer diagnosis.~   "
47926|NCT02939599|"~     This is a long-term open-label safety extension to the Phase 2a study of inhaled QCC374 in~     adult patients with PAH. This study provides the patients who completed the QCC374X2201 study~     with the option to continue receiving QCC374. The study will monitor the long-term safety,~     tolerability and efficacy of QCC374 in patients with PAH.~   "
47927|NCT02939586|"~     Sleep disturbance is a significant issue in people undergoing dialysis. More than 80% of~     haemodialysis patients complain of difficulty sleeping. Inadequate sleep can cause poor~     daytime function and increased risk of motor vehicle incidents.~      One of the common reasons for sleep disturbance in dialysis patients is sleep apnoea. Sleep~     apnoea involves pauses in breathing that occur during sleep. Each pause can last only a few~     seconds or minutes. Severe sleep apnoea reduces oxygen supply and increases risk of heart~     attack and stroke, which are the leading causes of death in dialysis patients.~      In this project, the investigators will examine how a change of dialysis treatment might~     improve sleep. This project will first identify patients at risk of sleep disturbance using~     surveys and a subsequent sleep study. The investigators will then test different dialysis~     models to see the effect of dialysis treatment on sleep apnoea. The aim is to find a dialysis~     model that works better for patients with sleep apnoea.~   "
47928|NCT02939573|"~     Multi-center sequential multiple assignment randomized trial comparing the effectiveness of~     three different standard of care treatment options for patients with isolated skin~     vasculitis.~   "
47929|NCT02939560|"~     The goal of this proposal is to investigate whether a standard rTMS protocol for depression,~     including multiple sessions applied to left dorsolateral prefrontal cortex (DLPFC) results in~     reduction of depressive symptoms for adult patients with ASD and MDD (Aim 1). The secondary~     goal is to investigate and whether there is any beneficial reduction in the core symptoms of~     autism (Aim 2).~   "
47930|NCT02939547|"~     This research study is being conducted to find out whether Trappsol® Cyclo™, an experimental~     treatment for people with Niemann Pick disease Type C (NPC-1) is safe at 2 different dose~     levels and what effects it has on people who have this condition. NPC-1 is caused by a defect~     in the protein which is important for the transport of fatty substances like cholesterol out~     of cells. Without this protein, fats build up in the cells ultimately leading to organ~     damage. The way in which this experimental treatment works is not fully understood but~     laboratory experiments have shown that it can potentially remove cholesterol build up from~     the cells in people who have NPC-1. Approximately 12 patients will be asked to take part in~     this research study for up to 20 weeks (w) in total (including screening. treatment and~     follow-up). Recruitment is expected to take 6- 9 months.Patients who take part will receive~     treatment by an intravenous infusion every two weeks. The study will look at what the body~     does to the drug as well as what the drug does to the body by taking and examining blood and~     urine samples. Samples of cerebrospinal fluid (CSF) will be taken by lumbar puncture during~     and following the first and subsequent treatment doses. Liver and skin biopsy specimens will~     be taken to assess filipin staining. Cholesterol metabolism will be investigated in liver~     samples and splenic and hepatic elasticity will be assessed by ultrasound..Patients will also~     have their hearing tested, be asked questions by their doctor as well completing~     questionnaires to help assess any changes in their condition during treatment.This study is~     being sponsored and funded by CTD holdings Inc. It is planned to be run in the USA,.~   "
47931|NCT02939534|"~     The way the immune system responds to certain PD-related proteins in PD donors compared to~     the way it responds in persons without or fewer PD related proteins is not well studied and~     this study aims to analyze the autoimmune response in each group. The study involves a one~     time visit involving brief questionnaires and a blood draw of 30 mL (approximately 2~     tablespoons) to be collected.~   "
47932|NCT02939521|"~     A prospective design that studies the effects of a new technique for the treatment of pincer~     nails. The technique consists of a flattening of the bone of the distal phalanx with a~     frontal skin lifting that is performed in patients with a pincer nail deformity. Visual~     Analog Scale (VAS) will be measure before surgery, one month and one year after surgery.~   "
47933|NCT02939508|"~     This prospective study was designed to compare the difference of effects of conventional~     treatment, medicine intervention, endoscopic therapy, and surgery between colon originated~     and non-colon originated ALGID in critical patients, in order to alert doctors to differ the~     treatment of the two ALGID and provide basis for treatment.~   "
47934|NCT02939495|"~     The purpose of this study is to evaluate the efficacy and safety of Dapoxetine/Sildenafil~     30/50 mg film-coated tablet in the treatment of men with premature ejaculation and erectile~     dysfunction.~   "
47935|NCT02939482|"~     The purpose of this study is to determine the effects of different rates of Caudal Epidural~     Steroid Injection (CESI) on clinical outcomes of the patients.~   "
47936|NCT02939469|"~     Since the invention of electrocardiogram (ECG), ECG has been an important part of clinical~     practice. A primary reason for the popularity of the ECG is that it is non-invasive and can~     be performed in any patient by placing electrodes on the skin. The present methods of ECG~     recording focus on detecting electrical signals from the heart. the investigators propose~     that with high frequency sampling and high pass filtering, the investigators can also record~     SNA from the skin. The somata of the subcutaneous sympathetic nerves on the skin are located~     at the ipsilateral cervical and stellate ganglia. Because the left stellate ganglion nerve~     activity (SGNA) is known to trigger cardiac arrhythmias, including AF, VF and VF, It is~     possible that skin SNA can also be used for arrhythmia prediction. the investigators tested~     that hypothesis in our preclinical studies (supported by R01 HL71140) using canine models.~     The results showed that subcutaneous nerve activity (SCNA) recorded with implanted electrodes~     can be used to estimate stellate ganglion nerve activity(SGNA) in normal dogs and in a canine~     model of ventricular arrhythmia and sudden death. the investigators also showed that SCNA is~     more accurate than heart rate variability in estimating cardiac sympathetic tone in~     ambulatory dogs with myocardial infarction.Therefore, SKNA and SCNA may be useful in~     estimating cardiac sympathetic tone. In addition to studying the autonomic mechanisms of~     cardiac arrhythmia, these new methods may have broad application in studying both cardiac and~     non-cardiac diseases. For example, sympathetic tone is important in the pathogenesis of heart~     failure, atherosclerosis, peripheral neuropathies, epilepsy, vasovagal syncope, renal~     failure, hypertension and many others diseases. Direct SKNA and SCNA recording may provide~     new approaches to study the mechanisms of these common diseases. SKNA recording may also have~     immediate clinical applications by assisting in the diagnosis and treatment of hyperhidrosis~     (sweaty palms), paralysis, stroke, diabetes, and neuromuscular diseases. It may be used to~     assist biofeedback monitoring performed by neurologists to control neuropsychiatric~     disorders. Because of these potential clinical and commercial applications, the investigators~     propose that this research project is significant.~      b. Innovation~        -  Using conventional electrodes on the skin to record SNA. The neuECG utilizes the~          conventional skin electrodes that are widely used in health care facilities. Skin SNA~          had been recorded using microneurography techniques, and had been estimated using~          cutaneous blood flow (vasodilator responses) skin temperature, skin conductance and~          sweat release. However, microneurography cannot be used in ambulatory patients. The~          other methods are not direct measurements of SNA. neuECG is the first method that can~          directly and non-invasively measure the SNA from the skin.~        -  Automated real-time signal processing. the investigators will develop signal processing~          software to automatically eliminate noise, such as that generated by muscle contraction,~          electrical appliances, body motion, respiration, and radiofrequency signals. The~          remaining signals are then processed to separately display in real time to provide~          health care providers a new method to instantly estimate sympathetic tone. The ECG~          signals are used for automated arrhythmia detection while the SNA signals are available~          for risk stratification. This approach allows us to improve and broaden the clinical~          application of Einthoven's original invention by simultaneous detecting ECG and SNA from~          the skin.~        -  SKNA patterns as new biomarkers. the investigators have identified unique SKNA patterns~          that precede the onset of human AF. If proven correct by Specific Aim 3, this new~          biomarker can help physicians to estimate the arrhythmia risk and to predict the~          efficacy of catheter ablation for AF.~   "
47937|NCT02939456|"~     This is a pilot study taking place at University Hospitals of North Midlands NHS Trust.~     Patients referred for MRI for possible prostate cancer will be invited to take part in the~     study. Following consent, participants will have an additional MRI sequence performed during~     their routine MRI called Double Inversion Magnetic Resonance Imaging (DIR-MRI).~      Participants scan images and prostate biopsy histology report (if applicable) will be~     reviewed by the research team.~   "
47938|NCT02939443|"~     Background: The aim of this study was to investigate the efficacy of prone-position computed~     tomography (CT) for detecting and classifying inguinal hernia relative to supine-position CT~     before laparoscopic inguinal hernia repair.~      Materials and Methods: Sixty-eight patients who underwent laparoscopic transabdominal~     preperitoneal repair of inguinal hernia were enrolled in this prospective study. Patients~     diagnosed with inguinal hernia by physical examination underwent abdominal CT in the supine~     and prone positions for preoperative assessment. The anatomy of the right and left inguinal~     regions was confirmed during the surgery and compared with the preoperative CT findings.~   "
47939|NCT02939430|"~     Sugammadex is new drug that is used for reversal of rocuronium induced muscle relaxation.~     benefits of reversal of neuromuscular blockade appears to be of great value in living donor~     liver transplant recipients. However, Few Clinical reports have investigated the~     anticoagulant effect of sugammadex. In this study, effects of sugammadex on bleeding profile~     of living donor liver transplantation will be investigated.~   "
47940|NCT02939417|"~     The aim of this study is to evaluate the clinical performance of E-max veneers cemented with~     and without using grape seed extract before bonding.~   "
47941|NCT02939404|"~     One reason people gain weight is eating more calories from food than what they need for~     energy over 24 hours. Metabolism is the amount of energy a person uses over 24 hours.~     Researchers want to study the relationship between changes in metabolism and how much a~     person eats.~      Objectives:~      To see how much food a person eats when the body's temperature is cooled. To study how~     changes in metabolism may alter the amount of food a person eats.~      Eligibility:~      Healthy people ages 18-55.~      Design:~      Participants will stay at NIH for 20 days.~      During the first 4 days, participants will have:~        -  Medical exam~        -  Electrocardiogram~        -  Blood and urine tests. One blood test includes drinking a sugar solution.~        -  DXA body composition scan~        -  Questions about foods they like, physical activity, and personal behavior~        -  Exercise test on a stationary bicycle~      Participants will spend 24-hour periods in a metabolic chamber. The chamber will be at normal~     room temperature or cooler.~      Some times, participants will eat a diet that matches their daily needs. Other times, they~     can eat as much as they wish from a vending machine.~      Participants will have blood and urine collected.~      Participants will swallow an ingestible wireless sensor and wear a small data recorder~     device.~      On the second to last day, participants will stay in the metabolic chamber but only consume~     water and non-caffeinated sugar-free beverages.~      Participants will come back for 1-day visits at six months and one year from the first~     admission. They will have blood and urine tests, and a DXA scan. They will answer questions~     on physical activity and food habits.~   "
47942|NCT02939391|"~     The primary objective is to evaluate the effect of KW-6356 on motor symptoms in Parkinson's~     disease and the primary endpoint is the change from baseline in the MDS-UPDRS part III score~     between KW-6356 and placebo in subjects with early Parkinson's disease in Japan.~   "
47943|NCT02939378|"~     Recently, ketogenic diet has been recognized a useful treatment strategy for glioblastoma in~     vitro.~      Therefore, the purpose of the study is to evaluate the safety and efficacy of ketogenic~     adjuvant to salvage chemotherapy for recurrent glioblastoma.~   "
47944|NCT02939365|"~     The purpose of this study is to determine the safety and feasibility of converting patients~     to Belatacept monotherapy (receiving just one immunosuppression drug), and to see what~     percentage of those patients can be safely converted to once every 8 week administration of~     Belatacept. Belatacept has been approved by the Food and Drug Administration (FDA) for kidney~     transplant recipients.~   "
47945|NCT02939352|"~     High relapse rates among substance dependent individuals are likely due to a combination of~     factors that involve limbic circuits in the brain involved in craving, including~     vulnerability to salient cues. Emerging data suggests that non-invasive, targeted brain~     stimulation may be able to modulate activity in these circuits and decrease craving. The~     primary goal of this pilot study is to determine the extent to which a single session of~     continuous theta burst stimulation (TBS) to the medial prefrontal cortex can attenuate limbic~     circuitry involved in craving among cocaine users and alcohol users. This will be tested~     through a double-blind,sham-controlled brain stimulation and brain imaging study in a cohort~     of polysubstance abusers and alcohol users.~   "
47946|NCT02939339|"~     The goal of this study is to determine whether transcranial magnetic stimulation (TMS) is an~     effective treatment in decreasing craving in individuals who habitually smoke cigarettes. The~     study consists of six total visits to MUSC; one for the consent process, two that will~     include MRI scans, and five that will include TMS administration. Compensation will be~     provided for each visit.~   "
47947|NCT02939326|"~     To evaluate the safety and efficacy of EB-001 compared to placebo in subjects with glabellar~     frown lines (GL).~   "
47948|NCT02939313|"~     The goal of this investigation is to determine if, in heavy alcohol users, a single session~     of transcranial magnetic brain stimulation (TMS) over a brain region involved in craving~     (medial prefrontal cortex) and a brain region involved in cogntive control (dorsolateral~     prefrontal cortex) can lower an individual's craving and brain response to alcohol cues. This~     study involves a screening visit, followed by three visits which involve brain imaging (using~     functional MRI) and brain stimulation (using TMS). There is also an additional Magnetic~     resonance spectroscopy (MRS) exploratory Aim in which we will measure the concentration of~     glutamate in the prefrontal cortex before and after a session of TMS.~   "
47949|NCT02939300|"~     This research study is studying a combination of two drugs as a possible treatment for~     Leptomeningeal Metastases from Melanoma.~      The names of the study interventions involved in this study are:~        -  Ipilimumab~        -  Nivolumab~   "
47950|NCT02939287|"~     The purpose of this study is to help answer the following research question:~        -  Whether administration of an aprepitant containing regimen or an olanzapine containing~          regimen will prevent nausea and vomiting better for patients undergoing an autologous~          stem cell transplant with melphalan chemotherapy. Both of these medications are approved~          by the United States Food and Drug Administration (FDA) for nausea and vomiting.~        -  Participants will be randomly assigned to one of the 2 treatment groups:~             -  Arm A: aprepitant plus standard anti-emetic regimen~             -  Arm B: olanzapine plus standard anti-emetic regimen~   "
47963|NCT02939118|"~     The purpose of this trial is to evaluate the long-term safety in subjects previously~     implanted with VC-01™ combination product.~   "
47951|NCT02939274|"~     The purpose of this Phase II study is to evaluate the efficacy and safety of Continuous Low-~     Irradiance Photodynamic Therapy (CLIPT) when used with Verteporfin in the treatment of~     cutaneous metastases of breast cancer for which no curative or significantly palliative~     therapy exists, including chest wall therapy.~   "
47952|NCT02939261|"~     The overall objective of this research is to test, among families with children age 2-5~     years, the immediate and longer-term impacts of a home-based intervention to improve~     household routines associated with reduced obesity risk. The investigators primary hypothesis~     is that, compared to control, children in the intervention group will have lower BMI~     following the 6-month intervention period and 18-month follow-up period. The secondary~     outcomes are change in children's % body fat, waist circumference and obesity-related~     behaviours: sleep, activity, sedentary behaviour, family meals, and dietary intake. Although~     child outcomes are the focus of this evaluation, changing household routines may also improve~     parent behaviour; thus, the investigators will assess change in parent behaviours and weight~     outcomes. This study will also assess the cost-effectiveness of the intervention from a~     societal perspective.~   "
47953|NCT02939248|"~     The purpose of this study is to evaluate differences in the pharmacokinetics and~     pharmacodynamics of ticagrelor and its active metabolite between patients who received~     ticagrelor and morphine followed by naloxone versus patients treated with ticagrelor and~     morphine alone for unstable angina pectoris.~   "
47954|NCT02939235|"~     The purpose of this study is to evaluate differences in the pharmacokinetics and~     pharmacodynamics of ticagrelor and its active metabolite between patients who received~     ticagrelor and morphine followed by metoclopramide versus patients treated with ticagrelor~     and morphine alone for unstable angina pectoris.~   "
47955|NCT02939222|"~     Implant placement may trigger bone trauma, which might result in 3-dimensional bone changes.~     While the process of peri-implant disease is not well understood, implant position within the~     bony structure might play a role. However, there is no data available on this regard.~   "
47956|NCT02939209|"~     Arthroscopic shoulder rotator cuff repair is associated with severe postoperative pain. The~     interscalene block (ISB) is commonly used for this type of surgery, providing analgesia by~     anesthetizing the nerves that supply the shoulder. Although the nerve block provides~     extremely effective analgesia for the first 6-8 hours, patients experience severe pain once~     its effect has regressed. This study will assess whether a single dose of oral hydromorphone~     controlled release, given to overlap the waning of the ISB, will improve postoperative pain~     control and reduce the incidence of rebound pain.~      Seventy patients undergoing rotator cuff repair will receive standardized ISB and general~     anesthesia for the surgery. Six hours after ISB, the patients will randomly receive either a~     single oral dose of 2 mg Hydromorphone (immediate release formulation) or placebo. The~     patient will be then discharged home with a prescription for multimodal analgesia, which is~     the standard of care. Patients will be given a diary to record their pain scores and track~     use of analgesic medications for 24 hours. Twenty-four hours after the ISB, the patients will~     receive a phone call from a nurse as per the standard of care. During this phone call,~     questions will be asked about their pain control.~      If a single dose of pre-emptive hydromorphone is demonstrated to be safe and effective, it~     will lead to change in practice of how we manage pain after rotator cuff repair. Furthermore,~     the finding of this study may apply to similar surgical procedures (such as elbow, knee and~     ankle repairs) that are associated with rebound pain when the nerve block wears off.~   "
47957|NCT02939196|"~     The purpose of the investigators'study was To compare 2 different diameter rigid hysteroscopy~     in vaginoscopic approach regarding pain during and after the procedure.~      And to evaluate patient acceptability and tolerability in order to determine the best way to~     perform hysteroscopy in an outpatient setting.~   "
47958|NCT02939183|"~     A study evaluating two new formulations of oprozomib plus pomalidomide and dexamethasone in~     patients with relapsed refractory multiple myeloma.~   "
47959|NCT02939170|"~     The purpose of this study is to evaluate the impact of back surface molded marks (MM) applied~     to delefilcon A contact lenses as measured by the incidence of ocular discomfort~     device-related adverse events with DAILIES TOTAL1® Multifocal contact lenses with molded~     marks (DT1 MF MM) and current DAILIES TOTAL1® Multifocal contact lenses (DT1 MF).~   "
47960|NCT02939157|"~     Assessment of pocket sized ultrasound (Vscan GE Healthcare) for diagnosing heart failure in~     primary care patients, with a comprehensive cardiac ultrasound examination (Siemens Acusan~     P10) performed at a specialized the eco.lab, as reference.~   "
47961|NCT02939144|"~     Aldosterone, the major mineralocorticoid hormone and cortisol, the major glucocorticoid~     hormone are produced in the adrenal gland. Aldosterone binds intracellular mineralocorticoid~     receptors (MR) in the kidney promoting urinary reabsorption of sodium and water and excretion~     of potassium and hydrogen ions. Unregulated mineralocorticoid excess may, therefore, lead to~     high blood pressure due to sodium and water retention and hypokalaemic alkalosis.~      Blood concentrations of cortisol which has equal affinity for MR are 1000fold greater than~     those of aldosterone. Therefore in order not to overwhelm MR, cortisol needs to be~     inactivated before it binds MR. This is achieved by the enzyme 11-betahydroxysteroid~     dehydrogenase type 2 (11ßHSD-2) in the kidney which rapidly inactivates cortisol to cortisone~     (this process allows only aldosterone to bind MR). Reduced activity of 11ßHSD-2 leads to an~     accumulation of cortisol which binds MR and hence has the effect of aldosterone. Reduced~     activity of 11ßHSD-2 may be seen in the inherited condition of 'Apparent mineralocorticoid~     excess (AME)' or in excessive liquorice ingestion. The diagnosis of AME and liquorice~     toxicity is difficult due to unavailability of diagnostic urine analysis in most general~     laboratories. Cortisol in the salivary glands, similarly to that in kidneys, is metabolised~     by 11β-HSD2 to cortisone. It is proposed that increased salivary cortisol/cortisone ratio~     could offer a simple and convenient diagnostic test for AME and liquorice toxicity and can be~     used as a surrogate marker of urinary cortisol/cortisone ratio. The advantages of salivary~     cortisol/cortisone include non-invasiveness making it stress free for the patient, no risk of~     needle stick injury and ease of collection allowing potential home testing and posting of~     samples.~   "
47962|NCT02939131|"~     IMPAACT 2002 is a prospective, multi-site, two-arm, cluster-randomized study to evaluate~     whether a health and wellness Cognitive Behavioral Therapy and Medication Management (COMB-R)~     intervention for depression demonstrates improved depression and medical outcomes for~     HIV-infected youth in the US compared to enhanced standard care (ESC).~   "
47967|NCT02939066|"~     Current modalities for lymph node staging in cancer can be limited. Needle-based confocal~     laser endomicroscopy (nCLE) is a novel endoscopic technique, which is compatible with the~     19-gauge FNA needle. Under endoscopic ultrasonography (EUS) guidance, nCLE enables real-time~     in vivo imaging of lesion tissues at cellular and subcellular levels.This study aimed to~     evaluate the feasibility of needle-based confocal laser endomicroscopy (nCLE) at the time of~     endoscopic ultrasound (EUS) and to describe the nCLE features that distinguish between benign~     and malignant lymph nodes.~   "
47968|NCT02939053|"~     This study aims to establish the degree to which change in the ratio of ECF to TBW measured~     using the SOZO BIS device correlates with change in end-expiratory end-diastolic PAP measured~     using the CardioMEMS HF System (St. Jude Medical).~   "
47969|NCT02939040|"~     This study is to assess the feasibility of using a positive activities intervention, Positive~     Piggy Bank, in newly diagnosed women with breast cancer who will soon undergo surgery. A~     randomized controlled pilot trial of a brief self-guided positive activities intervention,~     The Positive Piggy Bank (PPB), compared to Treatment as Usual. The PPB intervention involves~     noting at least one positive event each day, writing it down on a slip of paper and then~     depositing this piece of paper in a piggy bank. This practice is to take place at the end of~     the day, every day over a circumscribed period of time. At the end of the deposit period,~     in the case of this study after approximately 21 days, the participant closes the account~     and makes a full withdrawal by taking all of the slips out of the piggy bank and reading each~     one on the night before surgery.~   "
47970|NCT02939027|"~     Electronic brachytherapy (EBT) offers an isotope-free radiation therapy modality for the~     treatment of specific skin lesions, especially non-melanoma skin cancers (NMSC). Within the~     treatment of NMSC, surgical removal of the lesion is currently the treatment of choice for~     the majority of cases. However in an estimated 10-15% of NMSC patients, surgery might not be~     the best treatment option. Location of the tumour in cosmetically sensitive areas, patient~     comorbidities, old age, use of anti-coagulation etc. might all be reasons to select~     radiotherapy as first choice of treatment. The objective of ths study will be to determine~     histologically confirmed clinical efficacy, safety, and usability of Electronic~     Brachytherapy, an innovative treatment for Basal Cell Carcinoma (BCC).~   "
47971|NCT02939014|"~     The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics (PK) of~     brentuximab vedotin as a single agent in Chinese participants with relapsed/refractory CD30+~     Hodgkin Lymphoma (HL) or Systemic Anaplastic Large Cell Lymphoma (sALCL).~   "
47972|NCT02939001|"~     This study included patients who visit for refractive surgery (photorefractive keratectomy,~     photorefractive keratectomy with with corneal collagen cross linking, laser in situ~     keratomileusis, small incision lenticule extraction), phakic Intraocular Lens implantation~     (Implantable Collamer Lens, artiflex), and cataract surgery. Patients will be examined~     whether iris recognition scanner of smartphone works before and after surgery. In addition,~     before and after pupil dilation (5mm, 6mm, 7mm, 8mm), patients will be examined whether iris~     recognition scanner of smartphone works well.~   "
47973|NCT02938988|"~     The aim of this study was to evaluate the effectiveness of antimicrobial photodynamic therapy~     as an adjuvant of scaling and root planning for treatment of periodontal disease in patients~     with Down's Syndrome. After scaling and root planning, half of patients received~     antimicrobial photodynamic therapy with methylene blue dye and laser and the sessions were~     repeated after 3, 7 and 14 days. The other half received only scaling and root planning.~   "
47974|NCT02938975|"~     Purpose~      While there is strong evidence that permethrin treated clothing prevents insect bites there~     is insufficient evidence from trials to demonstrate a reduction in infections. The evidence~     that topical insect repellants prevent malaria is more robust, but studies in civilian suffer~     from poor compliance. It is not known if there is an added benefit from combining the two.~     The effectiveness of permethrin-treated uniforms with and without DEET lotion are compared in~     a 2x2 design in Mgambo Jeshi la Kujenga Taifa (JKT) military camp in Tanga region.~      The four arms are: 1) combined intervention group receiving permethrin treated uniform (PTU)~     and 30% DEET (diethyl toluamide) liposome formula; 2) permethrin intervention group receiving~     PTU and placebo lotion; 3) DEET intervention group receiving untreated army combat uniform~     (ACU) and 30% DEET liposome formula; 4) placebo group receiving untreated ACU and placebo~     lotion. Both participants and investigators will be blinded to treatment allocation.~      The outcome measure is the incidence of Plasmodium falciparum malaria infection measured by~     Polymerase Chain Reaction every month by active case detection.~   "
47975|NCT02938962|"~     The objective of this study is to evaluate and compare the effects of intravenous and topical~     administration of tranexamic acid during revision hip arthroplasty on blood loss, allogenic~     blood transfusion rates, length of hospital stay and perioperative complications.~   "
47976|NCT02938949|"~     Phase IV investigator initiated clinical trial to study the effectiveness of alirocumab, an~     inhibitor of proprotein convertase subtilisin/kexin (PCSK9), versus placebo added to~     high-intensity statin (atorvastatin 80 mg) in lowering low density lipoprotein (LDL)~     cholesterol during non-ST segment elevation myocardial infarction (NSTEMI).~   "
47977|NCT02938936|"~     Our study's principle purpose is to determine whether decreasing waiting time before being~     seen for antenatal care increases demand for and use of antenatal care services in~     Mozambique.~   "
47978|NCT02938923|"~     This study is a randomized, controlled multi-center clinical trial comparing the effects of~     six months of testosterone replacement therapy, with and without supervised exercise~     training, in frail elderly female hip fracture patients. One third of the participants will~     receive topical testosterone therapy and a supervised exercise training program; one third~     will receive topical placebo gel and a supervised exercise training program; one third will~     receive topical placebo gel and a home exercise program.~   "
47994|NCT02938715|"~     In this study, subjects who are attending the dermatology clinic and who have already been~     prescribed topical 5-fluorouracial for the treatment of actinic keratoses as part of their~     standard of care will be recruited. The purpose of the study is to assess patient~     satisfaction when engaging in follow up treatment of actinic keratosis via the~     HIPAA-compliant teledermatology platform called Klara. Additionally, the goal is to assess~     the difference in total duration of treatment between treatment and control group. A total of~     50 subjects will be enrolled and will be randomly assigned into the treatment group~     (teledermatology group; n=25) or control group (telephone only group; n=25).~   "
47979|NCT02938910|"~     Animal models have demonstrated the role of aldosterone in left ventricular remodeling~     involving fibrosis, apoptosis and hypertrophy. Myocardial fibrosis is a risk factor for~     serious arrhythmia and sudden death in ischemic and idiopathic hypertrophic heart disease. It~     is accepted that patients with primary aldosteronism have a higher prevalence of LV~     hypertrophy , arterial involvement and increased cardiovascular risk. In humans, a link has~     been demonstrated between aldosterone and heart failure as well as the benefit of the~     administration of an anti -aldosterone drug to lower mortality in this population ,~     regardless of blood pressure level . The administration of spironolactone ( aldosterone ) in~     hypertensive rats has prevented the occurrence of aortic fibrosis . Plasma aldosteronism in~     humans has been associated with inflammation, fibrosis and aortic stiffness . However,~     primary aldosteronism is generally associated with so-called secondary hypertension . Chronic~     hypertension alone is a recognized etiological factor of myocardial hypertrophy ( myocardial~     fibrosis very advanced ) . The purpose of this study is to investigate the effects of MRI~     hyperaldosteronism on the heart.~   "
47980|NCT02938897|"~     This study is a 12-week pilot randomized controlled trial to test the feasibility and~     effectiveness of a home telenutrition weight loss program in men in West Virginia.~   "
47981|NCT02938884|"~     The primary objective of this study would be to determine whether utilization of this~     technology improves adherence to recommended increases in hydration for stone forming~     patients with low urine volume relative to standard techniques such as education and reading~     materials. We hypothesize that the addition and utilization of the smart water bottle to~     standard recommendations will lead to measurable increases 24 hour urine output for affected~     patients.~   "
47982|NCT02938871|"~     The purpose of this study is to evaluate the use of synbiotic in patients after liver~     transplantation and assess the effect of these agents on postoperative infections, antibiotic~     use, length of hospital stay, mortality and nutritional status.~   "
47983|NCT02938858|"~     The registry aims to compare the two first-line available treatment approaches in~     non-high-risk APL patients aged ≤ 70 years - ATRA plus chemotherapy and ATRA plus ATO - in~     terms of practitioner's choice between the two options, clinical effectiveness and~     cost-effectiveness, long-term outcome, and short- and long-term toxic effects.~   "
47984|NCT02938845|"~     The purpose of this study was to identify factors that may contribute to anxiety of patients~     undergoing total abdominal hysterectomy(TAH) or total laparoscopic hysterectomy(TLH) before~     and after the operation. Thus, we aimed to learn whether anxiety levels change according to~     the type of hysterectomy.~   "
47985|NCT02938832|"~     This is a multi-centre, open, randomised study in patients treated for ischemic heart disease~     in Linköping, Norrköping and Jönköping hospitals. One thousand two hundred patients who are~     treated at the cardiac rehabilitation units will be consecutively recruited during three~     years. The patients will be randomised 1:1 to be given advice on a 1) Mediterranean diet with~     an energy content (E%) from carbohydrates between 25-30% or to 2) a traditional low-fat diet~     with 45-60 E% from carbohydrates. All eligible patients will be asked if they want to~     participate and provided with written information about the study when they are discharged~     from the hospital after treatment for ischemic heart disease. The decision to participate or~     not will be given at the following outpatient treatment at the cardiac rehabilitation unit.~     When the signed informed consent to participate in the study has been provided, the patient~     will be randomised to advice of either of the two dietary regimes.~   "
47986|NCT02938819|"~     Upper-limb disorders in patients with Parkinson's disease include decreased speed and~     amplitude of movements, difficulty in sequential tasks, and disrupted execution of fine~     manipulative hand activities.The aim of the study was to evaluate the effects of home-based~     goal-oriented upper limb intervention in patients with Parkinson's disease.~   "
47987|NCT02938806|"~     This study employs a cross-sectional design to profile the gut microbiome and urine~     metabolome in overweight/obese children with type 1 diabetes (T1D).~   "
47988|NCT02938793|"~     This is an investigator initiated single institution, open-label study to evaluate the~     antitumor activity, safety, and tolerability of durvalumab in combination with tremelimumab~     in subjects with select advanced rare solid tumors.~   "
47989|NCT02938780|"~     Preventing or reducing obesity is one factor that has been hailed as a way to improve quality~     of life, reduce recurrence, and increase survival rates among breast cancer survivors. An~     experienced team of multi-disciplinary researchers has developed an innovative and unique~     approach to encourage enhanced nutrition and exercise behaviors in this population using~     principles of behavioral economics. In particular, the use of social norms or exemplars has~     been shown in other applications to be effective, and if successful in this population could~     be inexpensively scaled up for widespread adoption. The proposed pilot study develops a~     system of text messages for social/mobile media that will provide ongoing reinforcement of~     desired behavior in breast cancer survivors. These messages would focus on achieving~     compliance with the expert-developed nutrition and exercise recommendations of the American~     Cancer Society. In the main study, 310 breast cancer survivors will be randomly placed in~     intervention and control groups for the 12 week study. Behavior change will be measured using~     established measures of self-reported behavior. In a sub-study, 60 of the breast cancer~     survivor participants will also provide blood and urine samples so changes in biomarkers can~     be assessed. The impact of the study will be measured by biomarkers and self-reported survey~     responses.~   "
47990|NCT02938767|"~     Cardiovascular (CV) disease is the main cause of death in patients on dialysis. The aim of~     this study is the long-term prognostic values of carotid intima-media thickness and coronary~     flow reserve in cardiovascular mortality of peritoneal dialysis patients.~   "
47991|NCT02938754|"~     In this study the investigators evaluate the effectivity of Virtual Reality-based~     rehabilitation protocols for preventing motor deterioration in patients with cerebral palsy.~   "
47992|NCT02938741|"~     ATG based conditioning regimen in HLA related allogeneic hematopoietic stem cell~     transplantation for aggressive T-cell tumors: multi-center, open, randomized controlled~     clinical study~   "
47993|NCT02938728|"~     Melanoma is the most aggressive skin cancer. Major advances in metastatic melanoma treatment~     emerge from new immunotherapies that target specific immune inhibitory checkpoint receptors,~     mainly PD1 and CTLA-4, and overcome the exhaustion state of T cells. In this context,~     checkpoint inhibitors, such as Ipilimumab (anti-CTLA-4 monoclonal antibodies, mAb) and~     Nivolumab or Pembrolizumab (anti-PD1 mAb), have demonstrated survival benefit in advanced~     melanoma patients. Anti-PD1 agents and combination of anti-PD1 and anti CTLA-4 have now been~     approved as first line therapy in melanoma. However, the predictive factors of response to~     these immunotherapies remain so far elusive. Recent studies provided consistent evidence that~     the immune infiltration could be tested as a biomarker for such immunotherapies. Moreover,~     the very recent concept of tumor neoantigens as biomarkers of response to anti-CTLA-4 mAb,~     and potentially also to anti-PD1 or combination therapies, is promising but needs to be~     further explored.~      In this context, the aim of our program is to identify and validate an immune signature~     predictive of anti-PD-1 benefit in the treatment of advanced melanoma patients. To this aim,~     tumor samples from 120 melanoma patients enrolled prospectively, treated with anti-PD1 mAb~     alone or combined with anti CTLA4, will be collected as well as the corresponding peripheral~     blood mononuclear cells (PBMC). Tumor infiltration with immune cells will be characterized on~     paraffin embedded melanoma samples. The investigators will also perform whole-exome~     sequencing on tumors and matched PBMC samples. Our primary objective is to develop a combined~     immuno-signature based on an immuno-score (CD3, CD8, CD45RO…) to quantify the in situ immune~     populations with a dedicated image analysis system combined with the simultaneous detection~     of CD8-PD-1 and PD-L1 by immunofluorescence in baseline tumor samples. This will permit to~     predict 1-year survival of patients with advanced melanoma treated with anti-PD1 and transfer~     in patient's care.~      Our secondary objectives are: 1/ To assess the interest of the detection of tissue-resident~     memory (TRM) T cells (CD8-CD103) as a predictive biomarker of response and survival at~     1-year; 2/ To extend the panel of neoantigens published by Snyder et al to other neoantigens~     using a next-generation sequencing (NGS) approach on tumor samples obtained before therapy;~     3/ To establish the prognostic value of this panel of neoantigens to predict tumor response~     to anti-PD1 and 1-year survival; 4/ To functionally validate the identified tumor neoantigens~     by stimulating patient PBMC with neoantigen peptides and measuring tumor-specific T-cell~     reactivity; 5/ To define the best marker and/or the best combination of markers predicting~     the overall response rate and the survival at 12 and 18 months; 6/ To attempt to establish a~     correlation between immuno-signature and neoepitopes and 7/ To transfer this immune signature~     in routine basis if validated.~      Thus, our project will integrate two complementary strategies to define a robust and reliable~     score system for predicting anti-PD1 targeting immunotherapy response. This study will~     provide a unique opportunity to validate various putative biomarkers in an integrated way~     that could help in determining the respective value of each isolated parameter and~     potentially lead to the definition of a composite biomarker. The identified immune signature~     would be of major interest in the field of cancer immunotherapy in order to select and manage~     patient treatment, and to consider the benefice or toxicities expected. It will also help to~     identify new target antigens of effective antitumoral immune responses and to understand the~     resistance mechanisms established by the tumor and its influence on the response to current~     immunotherapies.~   "
48020|NCT02938364|"~     The aim of this study is to evaluate the efficacy of two proposed non-invasive techniques:~     the ear plug technique and acupressure on the P6 point in reducing gag reflex during~     impression making and to assess patient's experience in terms of comfort and satisfaction.~   "
47995|NCT02938702|"~     The study is a multi-center prospective cohort study of active surveillance in papillary~     thyroid cancer with low risk. The purpose of the study is to observe natural course of low~     risk papillary thyroid cancer in Korean population, and comparison of prognosis between~     active surveillance group and conventional surgery group. Patient will be well informed about~     their choice of active surveillance or surgery.~   "
47996|NCT02938689|"~     This study is to compare the efficacy of exercises based on the lumbar extension and flexion~     on the pain relief and the prevention of pain recurrence in chronic low back pain patients.~   "
47997|NCT02938676|"~     Any member of the research team conducted screening for the selection of eligible patients.~     Nurses will be responsible for delivering the Guide tips for the person with a transplanted~     heart, thus initiating an individualized education program. Education will be held at the~     time of admission in which the patient has passed the most critical post-operative.~      Educational tips guide contains all the information necessary for the patient to have a first~     contact on the habits that must change. Education lasts 10-30 minutes and is taught in~     daytime, in a calm environment and at the right time, favoring the presence of the caregiver.~     Later, education is reinforced on the doubts that arise both the patient and the primary~     caregiver.~      During the first days of admission to the unit of cardiology, socio-demographic data of the~     patient and primary caregiver by the research team will be collected.~      A few days before discharge, having left time between 7-8 days after delivery of educational~     advice guide, any member of the research team, who does not work in the cardiology unit, will~     provide the patient and the primary caregiver the satisfaction questionnaire where the~     perception of information and education received during the postoperative period in the~     inpatient cardiology unit and the appropriateness of the topics covered in the guide~     educational advice.~   "
47998|NCT02938663|"~     The overall goal of this study is to examine the relationships between cultural identity and~     identity-based motivation, physical activity, diet and obesity risk in African-American~     adolescents. It was hypothesized that African-American youth who self-report a bicultural~     identity maintain health promotion beliefs and behaviors that reduce obesity risk compared to~     minority youth who only identify with one culture or neither culture. It was also~     hypothesized that African-American youth who self report a bicultural identity are more~     likely to hold beliefs about health promotion behaviors that are congruent with their~     cultural identity than compared to youth who only identify with one culture or neither~     culture.~   "
47999|NCT02938650|"~     We are looking to see how the addition of nitrosomonas alters the presence of nitrolipids and~     inflammatory cytokines on the skin.~   "
48000|NCT02938624|"~     A single arm, phase I, dose escalation trial and expansion cohort, examining the safety and~     feasibility of neoadjuvant pembrolizumab treatment for early resectable NSCLC patients.~      Hypothesis: The investigators hypothesize that response rate to neo-adjuvant pembrolizumab~     will be higher than the response rate of advanced NSCLC patients.~   "
48001|NCT02938611|"~     The main objective of this study is to evaluate the feasibility of estimating the prevalence~     of stage 4 and 5 chronic kidney disease in the Gard department of France from data obtained~     via laboratory databases. To verifiy if the demand for care thus authenticated by laboratory~     tests is adapted to nephrology care delivery, as recommended by the French High Authority of~     Health (HAS), laboratory data will be compared with those of patients seen by nephrologists~     in the department.~   "
48002|NCT02938598|"~     Mothers with symptoms suggesting clinical depression can be identified and potentially~     motivated to seek further care during pediatric visits for their young children. The best~     ways for pediatric providers to encourage mothers to seek further evaluation and treatment~     for their depressive symptoms are not known. The investigators plan to provisionally optimize~     a pediatric office-based intervention that the investigators developed to motivate mothers~     who may be depressed to seek further care and, thereby to improve the well-being of women~     from diverse backgrounds and their children.~   "
48003|NCT02938585|"~     This trial is conducted in China. The aim of this trial is to evaluate the clinical efficacy~     of turoctocog alfa in treatment of bleeding episodes in Chinese patients with severe~     haemophilia A (FVIII≤1%).~   "
48004|NCT02938572|"~     This trial is conducted in Europe. The aim of this trial is to investigate Pharmacodynamics~     (the effect of the investigated drug on the body) , Pharmacokinetics (the exposure of the~     trial drug in the body), and Safety of NNC0143-0406 in Subjects with Type 1 Diabetes Mellitus~   "
48005|NCT02938559|"~     The aim of this study protocol is to conduct a confirmatory efficacy trial to test whether~     the Memory Support Intervention improves illness course and functional outcomes in major~     depressive disorder (MDD) and cognitive therapy (CT).~   "
48006|NCT02938546|"~     The subject is going to use 18F-FDG PET/CT to assess different genetic NSCLC metabolism after~     cisplatin chemotherapy and targeted therapy, define the assessment criteria for the role of~     18F-FDG PET/CT in NSCLC treatment respone and at last build multi-centre clinical trial~     platform of molecular classification and molecular imaging for cancer chemotherapy~     assessment.~   "
48007|NCT02938533|"~     Interventions incorporating constructs from behavioral economics and psychology have the~     potential to enhance HIV 'treatment as prevention' (TasP) strategies. To test this~     hypothesis, the investigators evaluated a combination intervention to improve antiretroviral~     therapy (ART) adherence based on the concepts of social norms and priming.~   "
48017|NCT02938403|"~     This is a study to determine the efficacy of a smoking cessation intervention (nicotine~     replacement therapy (NRT) and counseling) done in a systematized manner with participants~     recruited from the UAB Substance Abuse Program. The definition of In Vivo experience is: use~     of the NRT medication during the session using specialized counseling focused around their~     experience of using NRT, including how the use of NRT may help them quit smoking, side~     effects, and smoking cessation expectancies. In this study those in the In Vivo group will~     put the patch on during Session 1 and given nicotine gum in Session 2 and will discuss the~     experience of wearing the patch or chewing the gum while they are in session. The control~     group will not put on the patch or chew gum during the sessions but will be given standard~     counseling regarding quitting smoking.~   "
48018|NCT02938390|"~     Approximately 100 women scheduled for NSM will be consented pre-operatively to participate in~     the study. US will be performed after induction of general anesthesia, prior to surgery using~     Sonosite™ portable US, 5-12mHz transducer using doppler mode.~   "
48008|NCT02938520|"~     The First Long-Acting Injectable Regimen (FLAIR) study is being conducted to establish if~     human immunodeficiency virus type-1 (HIV-1) infected adult participants whose virus is~     virologically suppressed on an integrase inhibitor single tablet regimen (INI STR) will~     remain suppressed after switching to a two-drug intramuscular (IM) long-acting (LA) regimen~     of cabotegravir (CAB) and rilpivirine (RPV). In this study, the INI STR will be limited to~     abacavir/dolutegravir/lamivudine (ABC/DTG/3TC). FLAIR is a Phase 3, multi-phase, randomized,~     open label, active-controlled, multicenter, parallel-group, non-inferiority study in HIV-1,~     anti-retroviral therapy (ART)-naïve adult participants. This study is designed to demonstrate~     the non-inferior antiviral activity of switching to a two drug CAB LA 400 mg + RPV LA 600 mg~     regimen every 4 weeks (Q4W: monthly) compared to remaining on ABC/DTG/3TC over 48 weeks (4~     weeks oral CAB + RPV, 44 weeks LA therapy). Participants who are HLA-B*5701 positive at~     Screening may enroll into the study and receive DTG plus a non-abacavir containing dual~     nucleoside reverse transcriptase inhibitor (NRTI) regimen. Eligible particpants will enroll~     into the Induction Phase of the study and receive ABC/DTG/3TC for 20 weeks (Week [-20] to Day~     1). Participants who have an HIV 1 ribose nucleic acid (RNA) <50 copies per milliliter (c/mL)~     at Week (-4) will be randomized (1:1) into the Maintenance Phase at Day 1 to either continue~     ABC/DTG/3TC or to discontinue ABC/DTG/3TC and begin oral therapy with CAB 30 mg + RPV 25 mg~     once daily for approximately 4 Weeks, followed by monthly CAB LA + RPV LA injections from~     visit Week 4b until study completion or withdrawal. At the end of the Maintenance phase,~     eligible participants who were randomized to continue ABC/DTG/3TC will be given an option to~     switch to LA therapy at Week 100. Those participants (HIV 1 RNA <50 c/mL at Week 96) will~     transition to LA dosing, beginning with approximately 4 weeks oral CAB + RPV therapy at Week~     100, and receive the first IM CAB LA + RPV LA injections at Week 104b. Participants will~     continue to receive injections every 4 weeks during the Extension Phase until CAB LA and RPV~     LA are either locally approved and commercially available, the participant no longer derives~     clinical benefit, the participant meets a protocol-defined reason for discontinuation, or~     until development of either CAB LA or RPV LA is terminated.~   "
48009|NCT02938507|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of~     different formulations of orally administered solabegron in healthy male subjects.~   "
48010|NCT02938494|"~     Safety and Efficacy of IDP-123 Lotion to Tazorac® (tazarotene) Cream, 0.1%, in the Treatment~     of Acne Vulgaris~   "
48011|NCT02938481|"~     The T-REX study aims to clarify the actual status of metastatic lymph node (LN) distribution~     in colon cancer and provide reliable evidence regarding the optimal length of bowel resection~     and the extent of central lymph node dissection in colon cancer surgery.~   "
48012|NCT02938468|"~     Chronic subdural hematoma (cSDH) is a collection of blood and its breakdown products in the~     subdural compartment. It is a condition frequently seen in any neurosurgical practice. cSDH~     is believed to arise from tearing of bridging veins as a result of trauma, which may be minor~     and unapparent to the patient. Management of cSDH is widely varied. A wait-and-see or~     wait-and-rescan approach may be acceptable in asymptomatic patients with a relatively small~     hematoma whilst cSDH with severe neurological deficits or decreased level of consciousness~     may require surgical decompression by burr-hole craniostomy, twist drill craniostomy or~     craniotomy. Surgery is associated with serious morbidity and mortality of up to 17% and~     recurrence rates of 4%-33% requiring further treatment in some instances.The safety and~     efficacy of different neurosurgical procedures have been evaluated but there is a paucity of~     well-designed randomized controlled trials in the literature. Consequently, there is no~     consensus on the best treatment with respect to surgical technique, pre-operative and~     post-operative management and nonsurgical alternatives including the use of Corticosteroids,~     Tranexamic acid, Osmotic diuretics, Atorvastatin or Angiotensin converting enzyme (ACE)~     inhibitors.~      Corticosteroids may be a therapeutic option in the management of cSDH. There is very little~     data on the efficacy of corticosteroids in the treatment of cSDH and certainly no randomized~     trials. The purpose of the study is to prove dexamethasone can be just as efficacious as~     surgery in treating chronic subdural hematoma. The investigators also hope to show that those~     patients treated with dexamethasone suffer less complication compared to those who undergo~     surgery.~   "
48013|NCT02938455|"~     In the last few years much attention has been paid to hyperalgesia induced by opioids, which~     represents a clinically significant condition following acute and chronic exposure to~     opioids. It has been suggested that the increase in gene expression of μ-opioid receptors and~     the development of hyperalgesia could be linked to epigenetic mechanisms. In particular the~     use of opioids seems to be related to an increase of the degree of DNA methylation. In the~     literature are not currently available data about the degree of DNA methylation in surgical~     patients, opioid-naive prior to surgery, receiving acute opioids treatment in the~     perioperative period.~      The primary objective of this study is to assess the degree of perioperative DNA methylation~     (extracted from whole blood) in patients undergoing major surgery exposed to opioids~     according to current clinical practice compared to preoperative baseline levels. The timing~     (preoperative vs intraoperative vs postoperative) in which the possible increase of the~     degree of DNA methylation will happen wil be assessed.~      20 consecutive patients undergoing major surgery performed under general anesthesia that have~     expressed their consent to participate to the study will be enrolled. This sample is adequate~     to allow the observation of a possible increase of DNA methylation in opioid-naive patients~     exposed to anesthesia/analgesia based on opiates according to current clinical practice.~   "
48014|NCT02938442|"~     The purpose of this research is to compare the effect on breast cancer of using a new~     experimental breast cancer vaccine (used to stimulate immune cell production) with~     chemotherapy and surgery versus the usual treatment of chemotherapy and surgery.~   "
48015|NCT02938429|"~     This study will be a cross sectional assessment of physical activity as measured through~     accelerometers and its association with endothelial function of children with Fontan~     circulation and healthy age and gender matched controls who are followed at the University of~     Alberta - Stollery Children's hospital.~   "
48016|NCT02938416|"~     Our participants will include 40 patients within one month of stroke, 40 patients who~     received total hip replacement or total knee replacement two to four weeks before. The~     participants will be randomly assigned to the isokinetic training group or the isotonic~     training group. Outcome measures including isometric peak torque of hip/knee at 90 degree of~     flexion, peak torque of hip/knee at angular velocity of 60 degree/s and 120 degree/s, Short~     Form 36 (SF-36), the Timed Up and Go test, the Oxford Hip/knee Score, the plasma~     concentration of hsCRP, and the level of substance P in saliva will be collected at the~     beginning and 4 weeks after the training program. Statistical significant differences will be~     determined between the improvement of outcome measures of the isokinetic and the isotonic~     training groups.~   "
48019|NCT02938377|"~     Aim 1: Examine effects of algorithm-guided alcohol treatment on alcohol consumption and~     alcohol use Disorders (AUD) symptoms.~      Aim 2: Examine effects of algorithm-guided alcohol treatment on retention in HIV care and~     HIV-related outcomes.~      Aim 3: Examine effects of algorithm-guided alcohol treatment on comorbid conditions~   "
48022|NCT02938338|"~     The aim is~      to examine the energy consumption before and after bariatric surgery. The study will~     contribute to the knowledge if operations should be complemented by interventions to increase~     energy expenditure, mainly by reducing sedentary.~      as input for the design of an intervention to reduce sedentary. Such intervention should be~     based on knowledge of the mediators of physical activity among the subjects that need to be~     strengthened.~   "
48023|NCT02938325|"~     General anesthesia (GA) is the process of induction of unconsciousness in order to undergo~     surgery. Unlike sleep, a process of anesthesia is not related at all, 'Sleep' and does not~     include dreams - but is done by using drugs that cause a kind of unconsciousness control.~      The induction of GA includes combination of drugs - for sleep (inhalation anesthesia or~     hypnotic drugs intravenously), analgesia (opiates) and muscle relaxants. Since most of our~     patients paralyzed during surgery, the anesthesiologists have no way of knowing whether our~     paralyzed patient is asleep or awake. If the patient is awake and paralyzed, a situation~     named awareness under anesthesia it can cause him a traumatic experience that would leave~     him a cripple for his whole life.~      There are many stories about patients who lay paralyzed, awake, while been operated, who~     remembered every word of what happened during the operation and of course could not mark the~     anesthetist that they are awake. The anesthesiologist might suspect that his patient is awake~     and paralyzed through signals from the sympathetic nervous system - for example the~     increase in heart rate and blood pressure. But many of our patients receive different~     medications (eg, beta-receptor blockers that does not allow the rise of a pulse) obscuring~     the clinical signs, so that the patient is awake and paralyzed without being noticed by the~     anesthesiologist.~      Some patients are at a higher risk to suffer from awareness under anesthesia, because the~     anesthesiologist cannot provide enough anesthesia, due to their medical condition, for~     example: women in caesarean section under GA, patients in cardiac surgery or injured trauma~     patients.~      Twenty years ago, an EEG based tool, naming BIS was developed. Nowadays, BIS monitor's~     credibility is questionable 1. The effect of different hypnotic drugs is not uniform. 2.~     Recently it was shown that a paralyzed patient BIS index could fall mimicking a situation of~     a sleep - enabling a paralyzed patient being awake. Thus, it is not clear whether the~     calculation of the BIS monitor is based on physiological models that define what is~     consciousness, loss of consciousness and how consciousness arises. It seems that the BIS is~     only suitable for certain drugs - not as a general monitor for the level of anesthesia.~      The purpose of the present study is to develop a universal system for determining awareness~     under GA using an innovative algorithm for analyzing EEG waves, based on the physiological~     processes of attention and perception underlying the basis for sedation and GA.~   "
48024|NCT02938312|"~     This study is being conducted in 8 rural counties in Alabama and Mississippi (4 per state).~     Approximately 400 overweight or obese African American women living in the selected counties~     will participate in a 2-year weight loss study.~   "
48025|NCT02938299|"~     Phase III, open-label, randomized, controlled multi-center study. In the study, 214 patients~     will be enrolled and parallel assigned (via randomization system) in a 1:1 fashion to one of~     two different arms.~   "
48026|NCT02938286|"~     The purpose of this study is to compare the effect of pretreatment with two different~     ablative laser modalities, a CO2 laser and an Er:YAG laser, and to assess the role of laser~     density in fractional laser assisted topical anesthesia.~   "
48027|NCT02938273|"~     This is an open-label phase IB trial with Bioimmunoradiotherapy, i.e. concurrent radiotherapy~     with intravenous administration of cetuximab and avelumab followed by avelumab maintenance~     therapy in patients with locally advanced head and neck cancer, unfit for cisplatin.~   "
48028|NCT02938260|"~     Atrial fibrillation (AF) is the most common arrhythmia, accounting for one third of all~     hospital admissions and 1% of all emergency department visits (ED). Approximately 65% of~     those presenting to the ED with AF are admitted. There are also numerous reasons for patients~     to get AF with rapid ventricular rate (AF RVR) during hospitalization. In the acute setting~     these patients are often treated with diltiazem, a non-dihydropyridine calcium channel~     blocker (ND CCB), or metoprolol, a beta blocker (BB). Non-dihydropyridine calcium channel~     blocker (diltiazem and verapamil) use is considered harmful and national guidelines recommend~     against use in patients with decompensated heart failure (HF). This recommendation is based~     on studies with long-term treatment. The purpose of this study is to assess the difference~     between metoprolol and diltiazem for the acute treatment of AF RVR in patients with HF with~     reduced ejection fraction (HFrEF).~   "
48029|NCT02938247|"~     The aim of the study is to assess gastro-intestinal tolerance, palatability, compliance, and~     use of a high caloric, high protein oral nutritional supplement (ONS) in elderly people~   "
48030|NCT02938234|"~     The aim of the study is to assess gastro-intestinal tolerance, palatability, compliance, and~     use of a high caloric, high protein oral nutritional supplement (ONS) in elderly people~   "
48031|NCT02938221|"~     The study investigates the feasibility and safety of the telemedical implementation of three~     diagnostic oculomotor tests using a video-oculography device and an extended teleconferencing~     system. The testing battery comprises Halmagyi's head impulse test, test for nystagmus and~     test of skew (vertical misalignment) known as the HINTS protocol. Previously published data~     have shown high sensitivity and specificity of the protocol for the discrimination of central~     and peripheral causes of acute vestibular syndrome. In this study the three tests will be~     executed on 30 healthy subjects using video goggles (EyeSeeCam, Interacoustics GmbH, Germany)~     connected to a mobile wireless-workstation for bidirectional audiovisual communication in a~     clinical environment (MEYTEC GmbH, Germany). A newly developed remote control and video~     conferencing solution allows the execution and evaluation of the HINTS protocol in a~     telemedical setup.~      The examination is guided by a remote physician using the help of a trained assistant~     attending to the subject. Corresponding clinical bedside tests will be executed for~     comparison. Primary endpoint is feasibility of the three diagnostic tests in a telemedical~     setting. Safety as well as accuracy of the telemedical versus bedside examination will be~     analyzed as secondary outcome measures. Aim of the study is to improve diagnostic accuracy~     for patients with acute vestibular syndrome in remote areas where specialists are rare.~   "
48032|NCT02938208|"~     This investigation is a prospective non-blinded and non-randomized clinical investigation.~     This investigation is designed to evaluate the performance (leak and comfort) as well as~     participant's overall acceptance of the Jupiter mask amongst OSA participants. A total number~     of up to 15 OSA participants who currently use full face masks will be recruited for the~     trial.~   "
48033|NCT02938195|"~     The investigators designed a new preoperative chemoradiotherapy regimen to focus on the most~     important radiation area and hope to reduce the radiation volume and try to reduce the~     postoperative mortality and treatment-related mortality.~   "
48034|NCT02938182|"~     The underlying mechanisms of association between the right-to-left shunts (RLS) and migraine~     may concern with platelet aggregation and paradoxical embolization. The aim of the study is~     to evaluate the prophylactic effectiveness of clopidogrel for migraineurs with RLS.~   "
48035|NCT02938169|"~     The purpose of this study is to determine the effective exercise protocol in chronic low back~     pain patients.~   "
48036|NCT02938156|"~     Severe haemophilia A and B (SHA, SHB) are inherited bleeding disorders affecting male~     patients and are characterised by low levels of circulating clotting factors VIII and IX~     respectively. Clinically low levels present with multiple recurrent bleeds into joints and~     muscle from the first couple of years of life. In addition patients may present with~     spontaneous and potentially fatal bleeding into any organ. The mainstay of treatment is~     replacement with the missing factor in the form of intravenous injections of factor VIII and~     IX. Clotting factors can be given to treat a bleed or can be given to prevent a bleed, and~     the latter is termed prophylaxis. Regular prophylaxis is the current standard of care and~     aims to decrease spontaneous bleeding events and resulting joint damage, and this requires~     patients to self-infuse factor into their veins two to four times week. Patient's compliance~     with prescribed regimen and recommendations has a significant influence on outcomes.~      Advances in biomolecular and protein engineering have extended the duration of the effect of~     clotting factor VIII and IX through multiple mechanisms. This extension of the duration of~     the effect presents the clinician and patients with opportunities to tailor the treatment to~     their particular needs, circumstances and body other characteristics. It has been suggested~     that decreasing the frequency of infusions will improve adherence and thus contribute to~     improved outcomes.~      In rare disorders, it is an accepted fact that post-marketing studies are crucial to~     understand the generalisability of the efficacy and safety outcomes and identify any new~     safety and efficacy concerns in relation to specific population group. The investigators~     propose the development of a registry for systematic collection of information with the dual~     aim of analysing the relationship between patient and treatment characteristics, and~     outcomes, and simultaneously identify areas for practice development that can improve the~     overall quality of life experienced by the haemophilia patient community.~   "
48037|NCT02938143|"~     Patellar tendinopathy is a frequent overuse injury that causes pain and impaired performance~     in jumping athletes. Exercise therapy is considered the best initial treatment option for~     tendinopathies as clinical improvements in pain and function have been demonstrated. Although~     painful eccentric exercise protocols have been promoted as standard care based on positive~     results in early studies, a recent systematic review demonstrated that these are not~     associated with improved tendon structure and are ineffective when applied in-season.~     Progressive tendon-loading exercise therapy for patellar tendinopathy constitutes a novel~     concept in sports medicine. A recent study advocates a progressive 4-stage criteria-based~     exercise protocol as it results in a less reactive tendon and ability to restore collagen~     alignment. This protocol consists of progressive isometric, isotonic, plyometric, and~     sport-specific exercises. Isometric exercises have been shown to reduce pain and decrease~     motor cortex inhibition of the quadriceps. This approach would enable jumping athletes to~     resume sports within the limits of pain, with improved muscle function, and sufficient tendon~     structure re-organization. The diagnostic imaging work-up of patellar tendinopathy typically~     consists of ultrasound, magnetic resonance imaging (MRI), or a combination of both.~     Ultrashort echo time (UTE) MRI is an advanced MRI technique, which enables assessment of~     tissues with short T2-time, such as tendon, the structure of which is invisible on regular~     MRI. UTE has been shown to quantitatively depict changes in tendon microstructure and~     therefore allows in-vivo evaluation of tendon regeneration. It is currently unknown whether~     quantitative UTE MRI parameters change after exercise treatment, are related to clinical~     symptoms of patellar tendinopathy, have prognostic value for exercise treatment response, and~     offer additional value over ultrasound~   "
48038|NCT02938130|"~     People with disabilities experience a staggering incidence of secondary conditions that can~     result in death or negatively impact their health, participation in the community, and~     quality of life. Many of these chronic secondary conditions are preventable. The Institute~     for Healthcare Improvement has advocated for optimizing care through programs that~     simultaneously improve health and the patient experience of care, while reducing cost, called~     the Triple Aim. Studies have shown that the Triple Aim can be achieved through programs~     that facilitate community integration; however the U.S. healthcare system lacks a paradigm of~     care for individuals with disabilities that promotes community integration. In order to~     identify potential models of healthcare delivery for individuals with disabilities that are~     effective in achieving the Triple Aim, we will conduct a rigorous research project to~     evaluate the impact of two different models of care on the Triple Aim: 1) a community-based~     care management program delivered by a non-profit organization through waiver funds, and 2)~     the Program for All-inclusive Care for the Elderly (PACE) applied to younger individuals with~     disabilities between ages 55-64.~   "
48039|NCT02938117|"~     Nowadays, eccentric exercise can be realized in a dynamic way with an ergocycle wich permits~     eccentric (ECC) lower limbs contractions at a defined power output. With this type of~     ergometer, O2 consumption (VO2) in ECC is three fold lower than in concentric (CON) for the~     same power output. Consequently, ECC program could be used in chronic disorders with limited~     capacities, such as obesity.~      The investigators hypothesis that an eccentric training program, as it will induce higher~     mechanical constraints, would improve body composition, especially by reducing fat mass. This~     effect could be explained by an increased rest energy expenditure and a better improvement in~     biological parameters (particularly lipid profile and insulin-resistance) after ECC training~     (versus CON training).~      This study aims to compare the modification of fat mass after an ECC program versus a CON~     program at the same VO2. The secondary goal is to assess the physiological mechanisms~     involved in the modification of body composition~   "
48040|NCT02938104|"~     The investigators propose a randomized controlled study in patients undergoing lung resection~     for cancer to compare the impact of multimodal intervention composed of exercise, nutritional~     supplement and psychological well-being on functional exercise capacity. One group~     (rehabilitation group) will receive the multimodal intervention after surgery for 8 weeks;~     the other will start 4 weeks before surgery and continue for 8 weeks postop (prehabilitation~     group). In this case, both groups will be exposed to the program, which will be available to~     both groups postoperatively. One of the two groups will start this program 4 weeks before~     surgery and continue for 8 weeks postoperatively, and the other will start once they leave~     the hospital and continue for 8 weeks postoperatively.~   "
48041|NCT02938091|"~     The investigators evaluated dietary modulation of LIPC rs1800588 (-514 C/T) for lipids and~     glucose using a randomized cross-over design comparing a high-fat Western diet and a low-fat~     traditional Hispanic diet in Caribbean Hispanics (n=42; 4 weeks/phase).~   "
48042|NCT02938078|"~     The primary study objectives are: to evaluate (1) the change in ocular discomfort at 30 days~     and (2) the change in signs and symptoms of ocular surface disease in demodex-positive~     subjects beginning the use of Avenova.~   "
48043|NCT02938065|"~     The proposed study will use this technology to observe emptying of the stomach of a protein~     and carbohydrate rich clear liquid sports/nutrition drink.~   "
48044|NCT02938052|"~     The focus of this study is to examine the feasibility, acceptability, and preliminary impact~     of our customized positive psychology (PP)-based health behavior intervention in a group of~     patients with mild to moderate heart failure (HF).~   "
48045|NCT02938039|"~     This study will guide the anesthetists regarding the appropriate selection of the LMA in~     neonatal age group based on scientific basis.~      This study will add up to existing literature about the safety of LMA usage in neonates and~     infants. Furthermore it may shed some light on which LMA type will be more feasible and~     effective for neonatal/ infants usage.~   "
48046|NCT02938026|"~     Nutrition therapy is recognized as one of the crucial components for the standard treatment~     of diabetes along with physical activity and drug therapy. Of note, dietary habits are~     culture specific and hence understanding the dietary intake, eating behavior and physical~     activity level of the local population is important to formulate effective nutrition and~     lifestyle strategies. Weight control is a major therapeutic challenge because many~     conventionally used anti-diabetic agents, such as sulphonylurea and insulin, can cause weight~     gain, thus setting up a vicious cycle with increasing insulin resistance due to increasing~     levels of free fatty acids from adipose tissues . Although intensive face-to-face lifestyle~     intervention program has showed that even modest weight loss in people with Type 2 diabetes~     (T2DM) who were overweight or obese was associated with improvements in glycemic control and~     associated conditions, it may not be feasible in public hospital setting in Hong Kong due to~     factors such as limited resources, scheduling, patient's employment and willingness for~     frequent travel to the clinic. Hence, alternative strategies such as a combination of face-~     to-face individual dietary and lifestyle consultation together with telephone intensive~     lifestyle reinforcement program will likely to be an useful strategy to engage those obese~     T2DM patients through frequent individual contacts. On the other hand, bariatric surgery has~     emerged as an impressive therapeutic option for poorly control obese T2DM patients.~      Realizing there is a knowledge gap in understanding the lifestyle factors in the Hong Kong~     Chinese obese T2DM patients, we therefore propose to conduct a 1-year prospective clinical~     trial with two main objectives:~        1. To study and compare the glycemic and weight improvement after bariatric surgery versus~          a telephone intensive lifestyle intervention program for 1 year in Hong Kong Chinese~          obese patients with type 2 diabetes.~        2. To investigate the effect of lifestyle factors including dietary intake, eating~          behaviors and physical activity level on the glycemic and weight control of Hong Kong~          Chinese obese patients with type 2 diabetes.~   "
48047|NCT02938013|"~     Open-label, partially-randomized plasma and liver sampling study to assess hepatitis C virus~     (HCV) kinetics during treatment with two (Sofosbuvir/Velpatasvir) or three~     (Sofosbuvir/Velpatasvir/Voxilaprevir) direct acting antivirals (DAAs)~   "
48048|NCT02938000|"~     This pilot study intends to evaluate an online exercise video rehabilitation program for~     stroke survivors with moderate disability compared to usual care. The intervention videos~     combine aerobic and resistance training using a latex resistance band, Thera band® elastic~     band, specifically designed for rehabilitation. This study will aim to show that for patients~     suffering acute ischemic stroke resulting in disability, at-home physical therapy with~     aerobic exercise videos will improve depression level and aerobic capacity more than usual~     care.~   "
48049|NCT02937987|"~     The objective of this study is to describe and examine the dietary intake, eating behavior~     and physical activity level of a cohort of Hong Kong Chinese with T2DM and their association~     with weight and glycemic control at baseline and 1 year follow-up. The investigators~     hypothesize that Hong Kong Chinese T2DM patients with unhealthy dietary intake and pattern~     and low physical activity level are associated with poorer glycemic and weight control, and~     there will be no improvement with weight and glycemic control under usual care after 1 year.~   "
48050|NCT02937974|"~     Objective: A prospective multicenter randomized controlled trial to assess the efficacy and~     safety of Xuebijing injection for acute exacerbation of chronic obstructive pulmonary~     disease(AECOPD).~      Methods: 254 AECOPD inpatients will be recruited in 6 hospitals in China over 2 years. They~     will be randomly assigned to Experimental group and Placebo group，Experimental: Xuebijing~     injection 50ml in 100ml of Normal Saline IV, in 80mins, per 12 hours. administration of the~     agent for consecutive 5 days；Placebo Comparator: Normal Saline 150ml IV, in 80mins, per 12~     hours. administration of the agent for consecutive 5 days. Compare the following index~     between the two groups: Invasive mechanical ventilation rate, length of hospital stay, Treg~     cell,Th1,Th2,HLA-DR,CRP,PCT,IL-4,IL-6,IL-10,TNF-α，IFN-γ, APACHEⅡ, CAPS score.~   "
48051|NCT02937961|"~     Consecutive patients with cirrhosis and septic shock with AKI who give written informed~     consent will be included in this prospective trial. At baseline NT-Pro BNP, urine N-GAL will~     be done for all patients. A baseline serum blood sample (10 ml) and urine sample will be~     stored. Septic shock will be defined by the presence of two or more diagnostic criteria for~     the systemic inflammatory response syndrome, proven or suspected infection with hypotension~     non-responsive to adequate fluid resuscitation assessed by no evidence of stroke volume~     variation on flow track and need of a vasopressor to achieve a target mean arterial pressure~     (MAP) of ≥ 65 mm Hg. A record of CVP, IVC diameter and B-lines on ultrasound lung would also~     be done. Patients with age less than 18 years, severe known cardiopulmonary disease~     (structural or valvular heart disease, coronary artery disease, COPD) pregnancy, chronic~     kidney disease on hemodialysis, patients already meeting emergency criteria for immediate~     hemodialysis at the time of randomization as specified in the late group, patients~     transferred from other hospitals who have already been on hemodialysis before their arrival~     in the intensive care unit, extremely moribund patients with an expected life expectancy of~     less than 24 hours, failure to give informed consent from family members.~   "
48052|NCT02937948|"~     This study evaluates the effect of adaptative Intensity-Modulated Radiation Therapy (IMRT) in~     the treatment of locally advanced cervical cancer on acute genito-urinary (GU), and~     gastrointestinal (GI) toxicities. Every patients will be treated according to the adaptative~     IMRT strategy.~   "
48053|NCT02937935|"~     Intervention: All patients at presentation would be assessed for the underlying cause of and~     will be managed by removal of all precipitants(careful review of medications, diuretics,~     nephrotoxic drugs,vasodilators or non-steroidal anti-inflammatory drugs). The second step~     would be to consider plasma volume expansion in patients with hypovolemia (the choice of~     fluid could either be a crystalloid or albumin or even blood as indicated) along with~     identification and early treatment of bacterial infections. Along with this patients with a~     differential diagnosis of HRS-AKI would be given terlipressin ( or noradrenaline/octreotide~     midodrine in case of contraindication to terlipressin). Patients with a clinical diagnosis of~     ATN would be randomized to the on-demand versus protocol-guided dialysis groups. Further,~     patients with urine output of less than 0.5ml/kg/hour for 4-6 hours despite adequate fluid~     resuscitation and vasoconstrictors would also be subjected to randomization.~        1. In the on-demand group patients would get dialysis only when patient fulfills absolute~          criteria requiring dialysis such as metabolic acidosis with ph<7.2, hyperkalemia,~          refractory fluid overload (non-responsive to diuretics) or oliguria with urine output of~          less than 0.5ml/kg for more than 24-48 hours from the time of randomization~        2. In the protocol guided group patients all patients would be considered for dialysis~          within 6 hours of randomization After randomization patients would receive dialysis as~          three sessions per week of at least 4 h with a blood flow >200 mL/min and a dialysate~          flow >500 mL/min in intermittent group and as 20-25 mL/kg/h of effluent, by filtration~          and/or diffusion in continuous form until recovery of renal functions~   "
48054|NCT02937922|"~     Introduction: Endothelial dysfunction precedes atherosclerosis being evidenced in patients~     with hypertension. Increasing physical activity levels and/or physical exercise are part of~     the recommendations of antihypertensive therapy. However, the effects of oscillations and/or~     increase the systemic blood pressure induced by exercise session on endothelial function has~     not been studied.~      Objective: To evaluate the effect of aerobic exercise, resistance exercise and combined~     exercise on endothelial injury levels in patients with hypertension.~      Methodology: Hypertensive (n = 51) and healthy subjects (n = 30) (30-59 years old) will~     perform at random 40 minutes of aerobic exercise (50-60% of heart rate reserve) or 40 minutes~     of resistance exercise (4 x 12 repetitions of exercises for lower limbs, 60-70% of one~     repetition maximum and 60-90 second interval) or 40 minutes of combined exercise (20 minutes~     of resistance exercise and 20 minutes of aerobic exercise, in that order). Blood will be~     collected 10 minutes before, 10 and 60 minutes after intervention for the quantification of~     endothelial microparticles (MPE) circulating (induced endothelial lesion) and endothelial~     progenitor cells (EPC) circulating (endothelial recovery capacity) by flow cytometry.~     Ambulatory blood pressure monitoring (ABPM) will be held before and after the intervention.~     Ultrasonography is used to measure the flow-mediated dilation of the brachial artery 10~     minutes before, 10, 30 and 60 minutes after the intervention.~      Statistics: generalized estimating equation (GEE) for repeated measurements and Person~     correlation, being significant p < 0.05.~      It is expected to show results to ensure cardiovascular protection in patients with~     hypertension caused by different types of exercise and consequent endothelial injury and~     release induced regenerative factors. Knowledge of the magnitude of injury and endothelial~     recovery provided by different types of exercise can contribute scientifically to health~     professionals aimed at prescribing exercise with a vascular protective vision in patients~     with hypertension.~   "
48055|NCT02937909|"~     This study is designed to investigate whether the adoption of the use of a range of wound~     care products from a single manufacturer makes training in appropriate product selection more~     effective and results in more accurate selection of the appropriate product for the wound and~     for the patient's lifestyle, thereby incurring less waste and reducing the number of~     referrals by the community nursing team to the Tissue Viability Team.~      One community nursing team will switch to using a full range of dressings and compression~     products from BSN medical UK for three months. Nurse training on the products will be given~     and nurse competencies and confidence in woundcare and appropriate product selection will be~     tested at the start and end of the study.~      The number and type of referrals to the Tissue Viability Team will be measured.~      Total anonymised data on numbers of referrals, wound closure, numbers of wounds and quantity~     and cost of products used will be collected and compared with the historical record for three~     months prior to the study. Patients will complete a Quality of Life questionnaire at~     enrolment and exit from the study.~      Patients for whom BSN medical UK products are not appropriate or not desired by the patient~     will not be enrolled and will receive the usual range of products available to the community~     nursing team.~   "
48056|NCT02937896|"~     The aim of this study is the comparison of efficacy of intravenous ketorolac and intranasal~     desmopressin in renal colic patients pain control.~   "
48057|NCT02937883|"~     The purpose of this study is to evaluate the effects of an empowerment intervention for~     community-dwelling persons with young onset dementia and their informal caregivers.~   "
48058|NCT02937870|"~     The objective of this 4-treatment, 4-period, randomized, crossover, proof of principle bite~     force study will be to compare bite force measurements over a 12 hour period across two~     (test) cream denture adhesives, with a currently marketed cream denture adhesive (positive~     control), and a negative/no treatment control.~   "
48059|NCT02937857|"~     This is a multicenter, randomized, open Label,add-on study.~   "
48060|NCT02937844|"~     CAR T cell immunotherapy has achieved great success in CD19+ B-cell malignancies. Whether~     this new generation of cell-based immunotherapy can be applied to solid tumors remain to be~     investigated, partly due to hostile immune-suppressive tumor microenvironment which favors~     tumor growth but not immune system. Signaling pathway of programmed death 1 (PD-1) and its~     ligand PD-L1 plays an important role in suppressing immune response against tumors. PD-L1 is~     over-expressed in 88% of glioblastoma.~      We constructed a chimeric switch receptor (CSR) containing the extracellular domain of PD1~     fused to the transmembrane and cytoplasmic domain of the costimulatory molecule CD28. CSR~     modified T cells are able to recognize PD-L1-expressing tumor cells and transduce signals to~     activate T cells, which results in tumor killing. A truncated EGFR (tEGFR) which lacks of the~     ligand binding domain and cytoplasmic kinase domain of wildtype EGFR is incorporated into the~     CSR vector and is used for in vivo tracking and ablation of CSR T cells when necessary. This~     pilot study is to determine the safety and efficacy of autologous CSR T cells in patients~     with recurrent glioblastoma.~   "
48061|NCT02937831|"~     The purpose of this survey is to understand the following items observed in the actual~     clinical use of RIXUBIS.~        1. Unexpected adverse drug reactions~        2. Occurrence of adverse drug reactions in the actual clinical use~        3. Factors that may affect safety and effectiveness~        4. Occurrence of Factor IX (FIX) inhibitor development in patients with coagulation FIX~          deficiency~        5. Safety and effectiveness for hemophilia B patients who received routine prophylactic~          therapy, on-demand therapy and perioperative therapy~   "
48062|NCT02937818|"~     Study design This is a Phase II, open-label, multi-drug, multi-center, multi-arm,~     signal-searching study in patients with extensive-stage small-cell lung cancer (SCLC) who~     have refractory or resistant disease from prior platinum-based chemotherapy.~   "
48063|NCT02937805|"~     Vulvovaginal atrophy is a common problem associated with decreased levels of estrogen.~     Typical symptoms include feelings of dryness and uncomfort of the mucous membranes of~     intimate area. The objective of this study is to investigate the effects of a non-hormonal~     moisturizing cream on symptoms and signs of vulvovaginal atrophy and dryness.~   "
48064|NCT02937792|"~     To test the safety of high dose spinal in elective CS after prolonged sitting position.~   "
48077|NCT02937610|"~     PEG tubes are commonly used to provide nutritional support to patients with head and neck~     cancer. PEG insertions are typically carried out by gastroenterologists, but also~     otorhinolaryngologist - head and neck surgeons perform the procedure in some countries.~     Prospective studies on PEG tube placements in an ORL - HNS service are lacking. The~     investigators aim was to prospectively evaluate the preformance of ORL - HN surgeons in PEG~     tube insertions, and analyze the time gains and cost effectiveness achieved of the~     independency from other specialities.~   "
48114|NCT02937129|"~     The primary aim of this study was to determine the accuracy of an infrared thermometer~     compared to the gold standard, mercury-in-glass thermometer. The secondary aim was to compare~     tympanic and axillary temperature measurements by evaluating agreement and correlation to~     determine whether an infrared tympanic thermometer can replace an axillary mercury~     thermometer in the emergency department.~   "
48065|NCT02937779|"~     The World Health Organization recommends that all high endemic countries for HBV infection~     based their mother to child transmission prevention strategies on vaccination of all children~     and administration of immunoglobulins (HBIG) to infants born to infected mothers in the first~     24 hours after birth. Lack of access to antenatal screening and to HBIG significantly results~     in failure of this strategy in many countries. Moreover, despite sero-vaccination, 10 to 15%~     of infants of mothers that are positive for HBsAg and HBeAg are still infected, as high~     levels of HBV replication occurring in the third quarter of pregnancy act as a major risk~     factor.~      The objective of this study is to assess the effectiveness of an operational strategy to~     prevent HBV mother-to-child transmission (MTCT) in Cambodia based on the use of rapid tests~     HBs Ag and HBe Ag to screen HBV infection and a treatment by TDF for patients with a positive~     HBeAg test with a test and treat strategy for those seen for Antenatal Care (ANC) from 24~     weeks of amenorrhea. In all cases, vaccination of the newborn will be carried out according~     to the national protocol in Cambodia i.e. 4 injections at 24 hours, 6, 10 and 14 weeks of~     age.~      A phase IV multicenter observational and interventional non randomized prospective study will~     be conducted in 4 maternity in Cambodia.~      The primary outcome will be the proportion of active HBV infection in new-born at 6 months of~     life estimated by HBs Ag positivity.~      The study will aim to document the acceptability and the operational implementation of the~     study using rapid tests usable in all health centers and a drug available in all the country~     thanks to HIV national program. The results will be helpful for Cambodian government in order~     to implement guidelines and algorithm follow-up for HBV-infected pregnant women.~   "
48066|NCT02937766|"~     To demonstrate that Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) delivered~     subcutaneously via auto-injector is associated with less pain as compared to intramuscular~     injections of Makena®~   "
48067|NCT02937740|"~     Multicenter study consisting of two study periods as follows: a 90-day Treatment Period, with~     potential extension by 30 days for those patients requiring a dose increase, as determined by~     the treating physician. Participants receiving 122.5mg of NATESTO (5.5 mg of testosterone)~     per nostril twice daily may have an increased daily dose adjustment on Day 90, based on their~     hypogonadism symptoms.~   "
48068|NCT02937727|"~     Deep Brain Stimulation represents the golden standard for surgical treatment of Parkinson's~     disease (PD), but it is not optimally effective for controlling every motor sign and adverse~     events are not so infrequent. Therefore,other approaches should be considered. New Approaches~     in MRI at 3T and long-term local field potential (LFP) recording are very important to target~     subthalamic nucleus (STN) and understand mechanisms of DBS on Parkinson Patients. This study~     aims at evaluating the safety and effectiveness of 3T MRI Compatible and LFP recordable deep~     brain stimulation on PD patients. The Chronically LFP recording using G106R is for two goals:~     1) Evaluate the performance of long-term recordable neural simulation. 2) Study long-term~     clinical and electrophysiology effects of deep brain stimulation on STN.~   "
48069|NCT02937714|"~     Significantly higher prevalence of emotional and behavioural problems have been reported from~     Pakistan.This higher prevalence along with stigma of psychiatric problems and limited child &~     adolescent mental health services in Pakistan means that it is important to consider~     alternate methods for promoting psychological and emotional well-being of our youth. Schools~     can thus act as a natural platform for mental health promotion as schools context has almost~     as much impact on students' emotional health as the family context.~      Teachers' role in the school mental health initiatives cannot be overemphasized. Teachers own~     knowledge and beliefs regarding mental health influence the way they respond to students~     mental health crisis. Recognizing the need for wider implementation of evidence based school~     mental health interventions in the region and to help in addressing the mental health~     literacy of educators in resource constrained settings, World Health Organization, Eastern~     Mediterranean Region (WHO-EMRO) has developed a concise and practical manual of school mental~     health in December 2014. In the absence of any whole school approach study from Pakistan~     focusing on teachers training and addressing all the various evidence based components of~     promotion of positive mental health, Investigators aim to conduct a pilot randomized~     controlled trial to assess effectiveness of training based on WHO-EMRO manual, in addition to~     its feasibility & acceptability in improving teachers' mental health literacy and~     self-efficacy in dealing with students mental health issues.~      HYPOTHESIS:~      For teachers:~        -  School mental health training intervention will significantly improve teacher's mental~          health literacy & self-efficacy compared to wait list control group.~        -  At 3 months follow-up, control group teachers' mental health literacy will also improve~          compared to baseline due to contamination of information provided, across groups within~          the same school.~      All hypothesis pertains to individual level.~      For students:~      Mental health training of teachers would lead to an overall improvement in student's outcome~     measure (student's emotional and behavioural difficulties) at 3 months follow-up.~   "
48070|NCT02937701|"~     This trial is designed to determine what effects the human body has on the investigational~     medicine, ABP 710, and what effects the body has on the investigational medicine after you~     have been given it, and if this is comparable to what is seen for the licensed medicine,~     infliximab, in patients with moderate or severe rheumatoid arthritis (RA).~      This study will assess if the investigational medicine is safe and effective in~      treating moderate or severe RA compared to the licensed medicine.~   "
48071|NCT02937688|"~     To gather data on DBS Therapy effectiveness in different geographic populations.~   "
48072|NCT02937675|"~     This clinical trial is a Phase 1-2, open-label, sequential-group, dose-escalation and~     cohort-expansion study evaluating the safety, pharmacokinetics, pharmacodynamics, and~     antitumor activity of eFT508. The study will evaluate oral daily administration of eFT508.~     Treatment and study subject evaluation will be performed in 21-day cycles.~   "
48073|NCT02937662|"~     In this multi-center, randomized, open-label, prospective clinical trial, a total of 60~     relapsed/refractory AML patients will be randomized into 2 groups. In the experimental arm,~     patients receive IAC regimen. In the control arm, patients receive other physician-directed~     regimen. The primary end point is complete remission rate.~   "
48074|NCT02937649|"~     Staple-line leak is the most frequent and incapacitating complication after laparoscopic~     sleeve gastrectomy (LSG). The aim of this prospective randomized trial is to compare the~     staple-line leak rate after LSG according to the use of a bougie calibre of 36 or 48-Fr,~     assuming that a higher diameter is correlated with a lower risk of leak, without lowering~     long-term weight loss.~   "
48075|NCT02937636|"~     This single-centre, examiner-blind, randomized, stratified, two-treatment, parallel group~     clinical study will evaluate the efficacy of a 0.454% w/w stannous fluoride dentifrice~     compared to a reference dentifrice to control gingivitis (gingival bleeding and visual signs~     of gingival inflammation) in dentally and periodontally healthy adult volunteers over 12~     weeks use in a Chinese population.~   "
48076|NCT02937623|"~     A proof of principle single-centre, randomized-controlled, examiner-blind, two treatment~     group study to investigate the efficacy of an experimental 15% w/w dissolvable strip in~     relieving dentine hypersensitivity (DH) after a single application and up to 4 hours after~     application compared to no treatment.~   "
48078|NCT02937597|"~     Objective:~      To determine the effectiveness of proficiency based inter-professional communication training~     in an online environment on medical student's use of the ISBAR (Identify, Situation,~     Background, Assessment, Recommendation) communication escalation protocol in the~     deteriorating patient~      Setting: The study will be conducted in University College Cork, Ireland. Participants: Fifth~     year medical students, who are scheduled to undertake ISBAR training as part of the National~     Early Warning Score (NEWS) programme.~      Intervention: Participants will be prospectively randomized to one of three groups for~     training before undertaking a performance assessment of an ISBAR communication relevant to a~     deteriorating patient in a low fidelity simulation environment: HSE group (the national~     e-learning programme only); S group (national e- learning plus access to online scenarios and~     facilitator when requested) and PBP group (national e-learning plus access to online~     scenarios training course with in-built proficiency-based progression, and facilitator when~     requested).~      Main outcome and measures: A proficiency benchmark on the performance of ISBAR communication~     in the context of an acutely deteriorating patient.~   "
48079|NCT02937584|"~     To assess the effect of treatment with Glycopyronnium (GP) MDI administered twice daily (BID)~     and Formoterol Fumarate (FF) MDI administered BID on specific image-based airway volumes and~     resistance in subjects with moderate to severe chronic obstructive pulmonary disease (COPD)~     following chronic dosing after approximately two weeks treatment.~   "
48080|NCT02937571|"~     The purpose of this study is to test whether giving high doses of carfilzomib along with the~     other drugs (lenalidomide and dexamethasone) is safe and which dose is best tolerated by~     patients. In addition, the study is designed to test the amount of remaining myeloma cells in~     the body after treatment with higher carfilzomib doses which is known as minimal residual~     disease (MRD).~   "
48081|NCT02937558|"~     This is a Phase 2, multi-center, randomized, placebo-controlled, double-blind trial with~     open-label follow-up designed to assess the efficacy of Xeris Glucagon delivered as a~     continuous subcutaneous infusion to prevent hypoglycemia with lower intravenous glucose~     infusion rates in children < 1 year of age with congenital hyperinsulinism.~   "
48082|NCT02937545|"~     This study aims to compare patient use of and satisfaction with community~     pharmacist-delivered pharmacogenetic (PGx) testing delivered along or as part of a medication~     therapy management (MTM) service. Pharmacist and patient outcome measures will be collected~     by surveys, interviews, and review of pharmacy records.~   "
48083|NCT02937532|"~     The aim of the study is to evaluate whether combining cognitive-behavioral therapy (CBT) with~     task-oriented balance training (TOBT) is more effective than general health education (GHE)~     together with TOBT in promoting fear of falling and reducing activity avoidance behavior.~   "
48084|NCT02937519|"~     1. Observe and compare the chrono-chemotherapy IMRT and conventional chemotherapy and~          intensity modulated radiotherapy term efficacy of the treatment of locally advanced~          nasopharyngeal carcinoma.~        2. Evaluation chrono-chemotherapy IMRT and conventional chemotherapy and intensity~          modulated radiotherapy in locally advanced nasopharyngeal carcinoma safety and~          tolerability.~      3）observing the adverse reaction and effects of two groups,expected chrono-chemotherapy group~     can achieve lower toxicity, improve the curative effect, for the treatment of nasopharyngeal~     carcinoma provides a more reasonable way.~   "
48085|NCT02937506|"~     The primary purpose of this study is to determine if patient satisfaction with propofol is~     better than with non-propofol anesthesia for outpatient colonoscopies.~   "
48086|NCT02937493|"~     A total of around 351.500 consecutive patients admitted to Dep. of Trauma Surgery, Medical~     University Vienna, from 01/2008 to 12/2015 have been considered eligible for inclusion. Out~     of this patient population a total of 1.406 cases associated with IPV have been consecutively~     and prospectively included in our in-house screening service for IPV cases. Data collection~     was performed prospectively and statistical evaluation was performed retrospectively,~     approved by local IRB (1453/2016).~   "
48087|NCT02937480|"~     The majority of people after stroke demonstrate mobility limitations, which may reduce their~     physical activity levels. Task-specific training has shown to be an effective intervention to~     improve mobility in individuals with stroke, however, little is known about the impact of~     this intervention on levels of physical activity. The main objective will be to investigate~     the efficacy of a task-specific training, focused on both upper and lower limbs, in improving~     physical activity levels and mobility in individuals with stroke. The secondary objective~     will be to investigate the effect of the training, in improving muscle strength, exercise~     capacity, and quality of life. A randomized controlled trial with blinded assessment will~     assign eligible participants to either: 1) experimental group or 2) control group.~     Participants will receive interventions three times per week over 12 weeks. The experimental~     group will undertake task-specific training, while the control group will undertake global~     stretching and memory exercises, and health education sessions. Primary outcomes will include~     measures of physical activity levels and mobility, whereas secondary outcomes will be muscle~     strength, exercise capacity, and quality of life. The outcomes will be measured at baseline,~     12 weeks post-intervention, and four and 12 weeks follow-up. The findings of this trial have~     the potential to provide important insights regarding the effects of task-specific training,~     focused on both upper and lower limbs, in preventing secondary post-stroke complications and~     improving the participants' general health through changes in physical activity levels.~   "
48102|NCT02937285|"~     The relative effectiveness of current treatments and their different mechanisms of action~     yield to consider more and more that the multiple sclerosis (MS) therapeutic approach must~     use multiple molecules, both combined and sequential.~      In this sense, one can assume that the combination of two molecules with different but~     complementary mechanisms of action, can delay progression of the disease. Mitoxantrone has a~     powerful action, immediate and total, whereas interferon a selective action, immunomodulatory~     and delayed.~   "
48103|NCT02937272|"~     The main purpose of this study is to evaluate the safety of the study drug known as LY3200882~     in participants with solid tumors.~   "
48115|NCT02937116|"~     The purpose of this study is to determine the safety, tolerability and efficacy of IBI308~     monotherapy or in combination with chemotherapy in patients with certain types of advanced~     solid tumors. Another purpose is to determine the pharmacokinetics, pharmacodynamics and~     immunogenicity of IBI308~   "
48088|NCT02937467|"~     The incidence rates of thyroid cancers have increased in the past decade. Additionally, up to~     68% of people have thyroid nodules. Consequently, a precise evaluation of thyroid nodules is~     very important and can avoid unnecessary biopsy of benign nodules. Shear wave~     elastography(SWE), a novel ultrasound-based elastographic method, is a new real-time,~     quantitative, operator-independent, and reproducible technique. Briefly, shear wave~     elastography uses a radiation force produced by an ultrasonic beam to stress tissues and~     ultrafast sonographic tracking techniques to measure the speed of shear waves. Based on the~     Young modulus formula, tissue elasticity can be derived from the shear wave propagation~     speed, and a real-time color-coded elastogram can be displayed, showing softer tissue in blue~     and stiffer tissue in red.~      There are lots of research confirmed that SWE has a certain value in the diagnosis of thyroid~     carcinoma. These studies include prospective studies and retrospective studies, but both~     belong to a single center study. It has not been applied to the study of the multicenter of~     thyroid disease.~      The main purpose of the study is to assess the performance of SWE for identification of~     benign and malignant thyroid nodules and calculate the optimal cutoff value for each~     parameter in multicenter study; the secondary purpose is to evaluate the application value of~     SWE for uncertain nodules by FNA.~   "
48089|NCT02937454|"~     Study to Compare Ferric Carboxymaltose With Placebo in Patients With Acute Heart Failure and~     Iron Deficiency (Affirm-AHF)~   "
48090|NCT02937441|"~     The purpose of this study is to determine cerebral edema with evaluation of measurement of~     diameter of optic nerve sheath.~   "
48091|NCT02937428|"~     It is common for people to advise individuals undergoing vaccination to look away from the~     needle to make them hurt less and be less scary. However, this advice is not backed up by~     research evidence. the purpose of this study is to learn about how looking away vs. looking~     at the needle during vaccination makes people feel. People will be randomized to 1 of 2~     groups: look at the needle, look away. Then they will undergo vaccination and report on pain~     and fear experienced.~   "
48092|NCT02937415|"~     Waterpipe is a tool for smoking tobacco, which is thought to be less harmful than cigarette.~     Unfortunately, there aren't adequate studies about its harms to health that are threatening~     the young generation all over the world today. The objective of this study was to show the~     carbon monoxide (CO) levels in waterpipe smokers' breaths, whether can be used or not to~     reflect the changes of oxidative stress for this reason to predict harmful effects on the~     pulmonary functions.~   "
48093|NCT02937402|"~     This pilot clinical trial studies how well bronchoscopy with bronchoalveolar lavage works in~     identifying biomarkers of response to immune checkpoint inhibitors in patients with non-small~     cell or small cell lung cancer. Bronchoscopy uses a thin, tube-like instrument inserted~     through the nose or mouth to view the inside of the trachea, air passages, and lungs.~     Bronchoalveolar lavage washes out the bronchi and alveoli by flushing with a fluid.~     Bronchoscopy with bronchoalveolar lavage may make it easier to help determine biomarkers that~     are more present in some cancers than others that will help determine which individuals have~     a greater or lesser chance of benefiting from immunotherapy.~   "
48094|NCT02937389|"~     Gastric conduit ischemia or anastomotic breakdown after esophagectomy with cervical~     esophagogastrostomy often cause severe complications, such as leakage, necrotic organs, and~     strictures. Thus, the purpose of this study is the safety and efficacy of endoscopic~     evaluation about reconstructive organs after esophagectomy. The investigators evaluate~     endoscopic predictions using classifications in acute phase after esophagogastrostomy.~   "
48095|NCT02937376|"~     The purpose of this study is to investigate the effects of N-acetyl Cystein (NAC)~     supplementation on redox status, physiological and biochemical parameters in G6PD deficient~     individuals after acute exercise.~   "
48096|NCT02937363|"~     The purpose of this study is to investigate the effects of alpha-lipoic acid supplementation~     on redox status, physiological and biochemical parameters in G6PD deficient individuals after~     acute exercise.~   "
48097|NCT02937350|"~     The goal of this study is to better understand vitamin D catabolism and how it is affected by~     CKD and race. Specifically, the study team will evaluate the metabolic clearance of~     25-hydroxyvitamin D3 in individuals with varying degrees of CKD and among participants who~     self-report race as Caucasian, African American or African. The long-term goal of this work~     is to enhance the clinical evaluation and treatment of impaired vitamin D metabolism.~   "
48098|NCT02937337|"~     In this randomized controlled trial, we aimed to compare the efficacy of video-stylet guided~     laryngeal mask airway real time insertion technique with the standard recommended index~     finger-guided insertion technique in pediatric patients.~   "
48099|NCT02937324|"~     This study compares the comparing the validity and usability of smartphone software for home~     monitoring of symptoms and signs in Parkinson's disease as compared to the current clinical~     gold standard - the Unified Parkinsons Disease Rating Scale.~   "
48100|NCT02937311|"~     This study aimed to compare the effects of kinesiotaping, neuromuscular electric stimulation~     (NMES), and neuromuscular training on pain, and motor activity and function in patients with~     upper extremity hemiplegia.~   "
48101|NCT02937298|"~     Weight gain occurs because of imbalances in energy balance favouring energy intake. Whilst~     over 50% of a person's energy requirement goes towards the maintenance of physiological~     functions, around 40% is used for physical activity. In addition to this, around 10-15% of~     energy is spent on what is termed as Diet Induced Thermogenesis (DIT). Diet Induced~     Thermogenesis is the increase in energy expenditure following a meal, and represents the~     energy utilised for the digestion and metabolism of food. Some nutrients such as proteins~     require more energy to digest and therefore produce a greater DIT than others. In addition to~     this, some food components are able to independently stimulate calorie burning. For example~     caffeine, chilli, ginger and green tea have been shown to induce calorie burning through DIT.~     Therefore the inclusion of such foods in the diet could increase energy expenditure and~     thereby help in weight control.~      The objective of this study is to determine the DIT effects of some plant foods that are~     native to Scotland (blackberries, blueberries, red raspberries, wild garlic and sea~     buckthorn). These foods have been shown to contain compounds that stimulate DIT. If found to~     be effective, these foods could then be used to develop dietary strategies for weight control~     in Scotland.~   "
48104|NCT02937259|"~     Self-admission is a novel treatment tool whereby patients who are well-known to a service who~     have high previous utilization of health care are offered the possibility of self-admission~     to the inpatient ward for up to seven days without having their motive for admission~     questioned. Patients are free to admit themselves because of deteriorating mental health,~     acute stress, lack of structure in their everyday life, loneliness, boredom, or any other~     reason. The patients decide when they want to admit themselves and can discharge themselves~     at any time. The purpose behind the self-admission model is to increase the availability of~     inpatient care for severely ill patients, to avoid stressful and possibly destructive visits~     to the emergency service, and to decrease total inpatient care utilization. Patients offered~     a contract for self-admission usually have a history of repeated and prolonged~     hospitalizations. By encouraging them to monitor their own mental health status and allowing~     them to seek help swiftly when they are feeling poorly, the delay from first signs of~     deterioration to admission can be minimized and full-blown relapse can be avoided, ultimately~     reducing the total time spent in hospital. Until now, projects of self-admission have mainly~     targeted patients with long-standing psychotic disorders, such as schizophrenia, or bipolar~     disorder. Starting in August 2014, a four-year clinical project at the Stockholm Centre for~     Eating Disorders began offering self-admission to patients with severe and enduring eating~     disorders. The purpose of this study is to determine whether this model is viable in a~     specialized eating disorders treatment setting, if it does lead to increased patient~     participation and agency and a reduction of the total time spent hospitalized for this~     particular patient group, and if it is cost-effective.~   "
48105|NCT02937246|"~     Previous studies indicated that covered stents are less likely to become occluded in~     comparison to bare stents. While the probability of occlusions caused by tumor in-growth is~     less in covered stents, they are more likely to spontaneously migrate to a position that is~     distal to the original deployment site. However, newer covered stents with improved designs,~     such as the partially covered double bare metallic stent used for this study, include~     features to mitigate the migration issue. The purpose of this study is to confirm whether the~     difference in patency rate between regular covered stents and bare stents, which has already~     been well established by existing studies, is also reproducible when double covered stents~     are compared against double bare stents.~   "
48106|NCT02937233|"~     This is a phase 1 trial of one or more administrations of Zika Virus Purified Inactivated~     Vaccine (ZPIV). The trial will be conducted under a placebo controlled, double-blind,~     randomized allocation of study product. There are four groups in the study. Each group is~     testing a different vaccine schedule.~   "
48107|NCT02937220|"~     The aim of this study is to evaluate the influence of superstructure material on crestal bone~     resorption and esthetic outcome of dental implants in patients with single missing tooth in~     the aesthetic zone.~   "
48108|NCT02937207|"~     The purpose of this study is to evaluate the clinical efficacy of traditional Chinese~     medicine in the treatment of asthma, and to promote the application in community hospitals.~   "
48109|NCT02937194|"~     Early childhood caries (ECC) is a global health problem that causes pain and infection to the~     children affected. It is a common disease among preschool children in Hong Kong. There is a~     great need to improve at-home ECC preventive measures through oral health promotional~     activities as early as possible to parents.~      The investigators will propose a 4-year randomized controlled trial of family-centered oral~     health promotion for new parents which aims to increase the proportion of parents brushing~     their infants' teeth at 1 year, establishing proper feeding and dietary habits, reducing the~     transfer of MS from the parents to their infants and then reducing the risk of ECC of the~     children at 3 years. The investigators also aim to improve the oral hygiene status of the new~     parents and prevention of oral diseases among themselves.~      First-time expectant mothers and their husbands will be recruited. The recruited families~     will be randomly allocated to the test and control groups. In the test group, personal~     hygiene instruction (OHI) for the expectant mothers and their husbands together with oral~     health education materials on infant's tooth development and eruption, establishment of~     proper feeding, dietary and toothbrushing habits will be given before the delivery of the new~     born babies. Reinforcement of OHI and demonstrations on how to clean the infant's oral~     cavities and perform toothbrushing will be delivered after the babies are born. Comprehensive~     data will be collected from the mothers, fathers and the infants in both the test and control~     groups at different time points through dental examination, biological testing and~     questionnaire survey. The CONSORT statement will be strictly followed when conducting the~     clinical trial, analyzing the data and reporting the results.~      It is anticipated that the effectiveness of oral health promotion starting at the pregnancy~     period and for both expecting mothers and their husbands will be greater in preventing the~     infants from developing ECC. Furthermore, establishing good oral health care habits will have~     long term benefits, helping safeguard the oral health of the children as they grow and the~     family as a whole. This study will also provide much needed evidence for the further~     development of oral health policies and oral health promotion programmes in Hong Kong;~     specifically how these can be integrated into family health education so as to achieve a~     higher effectiveness. This will contribute significantly to the improvement of oral health in~     the population of Hong Kong.~   "
48110|NCT02937181|"~     Prospective look at antibiotic prophylaxis with Ceftaroline in patients with type II and III~     open fractures~   "
48111|NCT02937168|"~     This is an exploratory study with the primary objectives to 1) establish that PET/CT of the~     lung can reliably distinguish healthy, non-asthmatic volunteers from patients with asthma and~     an eosinophilic phenotype and 2) to examine the utility of PET/CT for demonstrating that~     reslizumab produces a reduction in lung inflammation in patients with severe asthma and an~     eosinophilic phenotype .~   "
48112|NCT02937155|"~     This study will look at cervical tissue samples in women with abnormal cervical cells to see~     if the frequency of the HPV 16/18 subtypes has changed in female populations today, after the~     introduction of the HPV vaccine. It will compare women who have been exposed to the HPV~     vaccine with those who have not.~   "
48113|NCT02937142|"~     Attention Deficit Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder which starts~     in childhood and is characterized by symptoms of attention deficit, hyperactivity and~     impulsivity. Persistence into adolescence is frequently associated with among other low~     educational achievement, interpersonal difficulties, anxious and depressive symptoms and~     sleep problems. Treatment guidelines recommend psychological treatment as part of the~     treatment plan, however compared to children and adults, there is still a substantial lack of~     knowledge about appropriate psychological treatment in adolescents. The present study~     examines a psychological intervention for adolescents with ADHD, cognitive behavior group~     therapy. The intervention consists of 12 weekly cognitive behavioral therapy sessions~     addressing core difficulties and concerns of the adolescent population with ADHD. The~     investigators wish to determine the efficacy of group therapy in adolescents with ADHD who~     receive medical treatment but still have impairing ADHD symptoms.~   "
48116|NCT02937103|"~     The overall purpose of this study is to explore the therapeutic effect of CD123-targeted~     chimeric antigen receptor T(CAR-T) cells in the treatment of Myeloid Malignancies.~   "
48117|NCT02937090|"~     Polycystic Ovary Syndrome is kind of disease with unclear etiology. Recent studies on~     intestinal microbiota have raised the possibility that dysbiosis of intestinal microbiota~     maybe a novel theory for the development of Polycystic Ovary Syndrome. Hence, the~     investigators will compare the intestinal microbiota composition and diversity in PCOS with~     age, BMI-matched control and then assess whether intestinal microbiota modification is~     associated with clinical and biological parameters.~   "
48118|NCT02937077|"~     Background:~      Different studies with real-life data and randomized controlled trials have shown a detection~     rate of paroxysmal atrial fibrillation (AF) of 10-20% in patients with cryptogenic stroke~     using insertable continuous cardiac monitoring for 6 months. More studies are needed,~     however, to identify factors which can be used to select the patients where the possibility~     of detecting AF with prolonged rhythm monitoring is highest, to evaluate the best duration of~     rhythm monitoring, to determine the optimal deﬁnition of short-term AF that warrants~     intervention and to evaluate whether intervention results in improved clinical outcomes.~      Methods: The NOR-FIB study is a multi-centre prospective observational trial, designed to~     evaluate detection of AF in cryptogenic stroke and transient ischemic attack (TIA). Patients~     admitted with cryptogenic stroke or TIA in stroke units in the Nordic countries, aged 18-80~     years are included and have the Reveal LINQ® Insertable cardiac monitor system implanted for~     12 months for the purpose of AF detection. Biomarkers that may identify patients, who could~     derive the most clinical benefit from the detection of AF by prolonged monitoring, are being~     studied.~      Conclusion: This NOR-FIB study will increase our knowledge regarding the occurrence of AF in~     patients with cryptogenic stroke and TIA that potentially can improve secondary prevention.~     The study will provide information on biomarkers that may be used to select cryptogenic TIA~     and stroke patients for long-term monitoring as well as information on the significance of~     short-term AF and optimal duration of cardiac rhythm monitoring.~   "
48119|NCT02937064|"~     The purpose of this study is to assess both osteoarthritis and other pathological knee~     conditions from the combination of signals that are known to provide information on the knee~     joint.~   "
48120|NCT02937051|"~     This study involves 25 current young adult combustible tobacco cigarette (CTC) smokers who~     will complete 5 Latin square ordered, within-subject, laboratory conditions that differ by~     the tobacco product smoked:~        1. own-brand CTC (positive control),~        2. original-flavored Black & Mild (B&M) cigar,~        3. apple-flavored B&M cigar,~        4. cream-flavored B&M cigar, and~        5. wine-flavored B&M cigar.~   "
48121|NCT02937038|"~     Purpose:~        1. Develop reference values for hydration biomarkers for children of 3 to 13 years old~        2. Explore the association between children's and parents' hydration markers and fluid~          intake habits in children aged 3-13 y~        3. Evaluate the equivalence of spot urine osmolality to 24h urine osmolality in children~          aged 3-13 y~        4. Evaluate the differences in hydration markers between school and non-school days in~          children aged 3-13 y~        5. Examine the role of different foods and fluids on hydration in children (3-13 y) and~          parents~   "
48122|NCT02937025|"~     This study mainly evaluated the feasibility and safety of a kind of Left Atrial Appendage~     Occluders which is to prevent ischemic stroke caused by nonvalvular atrial fibrillation (AF)~   "
48123|NCT02937012|"~     The primary biliary cholangitis (PBC), formerly known as primary biliary cirrhosis, treatment~     is based in the use of ursodeoxycholic acid (UDCA) at a daily dose of 13 to 15 mg/kg, without~     other treatment options. Patients with good or complete response to UDCA have more liver~     transplant-free survival and delay histologic progression compared to patients with partial~     or no response. Nowadays there is an estimated partial response to UDCA in approximately 30~     to 50% of patients with PBC. There is a need for new second line management strategies for~     patients without a biochemical response to UDCA.~      The addition of bezafibrate to the treatment of PBC patients with partial biochemical~     response to UDCA, will increase the biochemical response and improve the long term prognosis?~     And if so, which are the efficacy and security of bezafibrate in PBC patients without~     biochemical response?~   "
48124|NCT02936999|"~     The purpose of this study is to determine the safety and usefulness of oral Vitamin D~     supplementation in subjects with in situ carcinoma. More specifically, this study is being~     done to (1) understand the effect of Vitamin D supplementation on behavior of breast cancer~     cells and (2) the development of invasive breast cancer disease.~   "
48125|NCT02936986|"~     The differential diagnosis of gastric subepithelial tumors by endoscopic ultrasound is~     currently suboptimal. Needle-based confocal laser endomicroscopy (nCLE) is a novel endoscopic~     technique, which is compatible with the 19-gauge FNA needle. Under endoscopic ultrasonography~     (EUS) guidance, nCLE enables real-time in vivo imaging of lesion tissues at cellular and~     subcellular levels. This study aimed to describe nCLE interpretation criteria for the~     characterization of gastric subepithelial tumors, with histopathological correlation, and to~     perform the validation of these criteria.~   "
48126|NCT02936973|"~     The primary objective of this multicenter randomized controlled trial is to evaluate~     treatment effectiveness of intervening simple obesity people with catgut implantation at~     preferred acupoints, which excludes placebo effect; the secondary objective is to evaluate~     safety and superiority of treating simple obesity with catgut implantation at acupoints to~     provide high-level evidence for it clinically.~   "
48127|NCT02936960|"~     The differential diagnosis of solid pancreatic masses by endoscopic ultrasound-guided~     fine-needle aspiration (EUS-FNA) is currently suboptimal. Needle-based confocal laser~     endomicroscopy (nCLE) is a novel endoscopic technique, which is compatible with the 19-gauge~     FNA needle. Under endoscopic ultrasonography (EUS) guidance, nCLE enables real-time in vivo~     imaging of lesion tissues at cellular and subcellular levels. This study aimed to describe~     nCLE interpretation criteria for the characterization of pancreatic masses, with~     histopathological correlation, and to perform the validation of these criteria.~   "
48128|NCT02936947|"~     That study combines High Frequency Percussive Ventilation (HFPV) with radiotherapy treatment~     in patients with tumors that are moving with respiration like breast or lung cancers. The use~     of a High Frequency Percussive Ventilation system leads to the cessation of respiratory~     motions while administering radiotherapy (RT) to tumors which allows a reduction of the~     amount of irradiated normal tissues and which potentially decrease radiation-induced~     collateral damages.~   "
48130|NCT02936921|"~     Several decades ago, France has made the choice to implement a national prevention program~     for congenital toxoplasmosis. The identification in their first trimester of pregnancy of all~     pregnant women who are susceptible to Toxoplasma infection has been mandatory since 1985. In~     1992, the decision was made to extent the program to the monthly retesting of all women~     identified as not immune, in an attempt to reduce the number of severely infected children.~      The systematic detection of all maternal and congenital infections has generated many~     questions from clinicians, biologists, parents and older patients, on the short and long-term~     prognosis of congenital toxoplasmosis, on the best tests to use to diagnose infections in~     mothers and children, on the efficacy of existing treatments, and on how to manage patients~     in the long-term.~      The need to answer these many questions has prompted the medical team working within the~     laboratory and the outpatient department of the Parasitology Department at the Croix-Rousse~     Hospital in Lyon to implement a clinical research program. It is based on the systematic~     inclusion in our cohort of all pregnant women whose infection is confirmed, on their follow~     up, in order to monitor the outcome of pregnancy 2) and on the follow up of their children in~     order to confirm their infection or to rule it out. All congenitally infected subjects~     undergo clinical examinations, serological tests and ocular examination at least once a year~     without age limit.~      The following data are prospectively collected in a dedicated database: gestational age at~     maternal infection and corresponding serological profile; type and dates of maternal~     treatment; findings of ultrasound tests and amniotic fluid analysis; serological and clinical~     findings at birth; types and dates of postnatal treatment; postnatal serological profiles;~     infection status at one year of age; long term clinical (ophthalmologic) et serological~     findings.~      These data have allowed producing original findings on the risk of maternal-foetal~     transmission according to gestational age at maternal infection, on the long term~     ophthalmological outcome of congenital toxoplasmosis and to offer guidelines for the~     diagnosis, treatment and follow-up of maternal and congenital infections.~      These efforts are still to be maintained in the future in order~        -  to further analyse the impact of puberty, pregnancy, or adult co-morbidities on the risk~          of ophthalmological events~        -  to increase precision around our risk estimates for materno-foetal transmission,~        -  to continue innovating in terms of diagnostic strategy to improve tests performances and~          reduce costs~        -  to explore new potential clinical outcomes such as neuropsychiatric disorders associated~          with congenital and postnatal infection~        -  to determine if infections due to oocysts could have different clinical outcomes than~          those due to the ingestion of cysts~        -  to assess the efficacy of treatments for maternal and congenital infections~   "
48131|NCT02936908|"~     Retrospective multicentric observational study exploring the population of adult~     neuromuscular patients presenting a respiratory distress requiring their admission in an~     Intensive Care Unit (ICU) for ventilatory support.~      Research of markers associated with long term mortality and ventilatory status.~   "
48132|NCT02936895|"~     Childhood deaths from pneumonia is almost 2000 times higher in developing countries than in~     developed countries. In 1970, pneumonia was responsible for 9% of all deaths in children~     under 5 years. This rate was 2% in 2007.~      Some studies have shown that supplementing with vitamin D reduces disease of the respiratory~     tract infection. Some other studies have shown anti-inflammatory effect of vitamin D in cell~     lines. Studies about the role of vitamin D supplementation in pneumonia in children are~     inadequate to conclude about its role.~      The aim of this study is to determine the efficacy of vitamin D supplementation in~     Respiratory Index of Severity in Children (RISC) hospitalized clinical outcomes of~     hospitalized patients with community-acquired pneumonia.~   "
48133|NCT02936882|"~     This study evaluates antral ultrasonography for the diagnosis of full stomach before surgical~     emergencies in pediatric population. Preoperative ultrasonographic antral evaluation is~     compared to peroperative gastric aspirate with nasogastric tube.~   "
48134|NCT02936869|"~     The purpose of this study is to identify the causal impact of performance-based monetary~     incentives in increasing postnatal care (PNC) referrals by traditional birth attendants~     (TBAs), via a randomized controlled trial (RCT).~   "
48135|NCT02936856|"~     Primary liver cancer is one of the most common malignant tumor and leading cause of~     cancer-related death worldwide. Basically therapeutic strategies were considered and given~     based on the staging of liver cancer. Thus, the confirmatory diagnosis of numbers and~     distribution of malignant lesions were extreme important. Enhanced CT or MRI is routinely~     imaging scans to detect and identify lesions. Unfortunately, some malignant lesions usually~     presented untypical imaging characteristics, especially among lesions no larger than 1 cm,~     which misleading to the exact staging of liver cancer and the optimal therapeutic strategies.~      Basically most of blood supply for malignant liver tumors is from the hepatic artery. Based~     on this fact, hepatic arterial digital subtraction angiography could potentially elevate the~     accuracy and sensitivity of detection malignant lesions numbers and distribution.~      In this study the investigators will compare the numbers and distribution of malignant~     lesions before and after hepatic arteriography, then to revise the staging of liver cancer~     and to provide better therapeutic strategies.~   "
48136|NCT02936843|"~     Diabetic neuropathy (DN) is the most common chronic complication of diabetes, affecting up~     to50% of individuals with type 1 diabetes (T1DM).~      Multiple pre-clinical and clinical studies demonstrate a pathogenic role for inflammation,~     especially cytokine production, in the disease course of DN and CAN. This suggests that~     agents with known anti-inflammatory properties, such as salicylates, may prevent the~     development of DN and the pain associated with DN. This study builds upon and expands on~     prior work done by the investigators with salsalate, a pro-drug form of salicylate, as an~     agent to address inflammatory pathways in people with T1DM.~   "
48137|NCT02936830|"~     The aim of this study is to compare the efficacy of dentine hypersensitivity reduction using~     in office paste formula containing nanoHydroxyapatite with the commercially available~     fluoride (duraphat) and a placebo in treating hypersensitivity in a single visit.~   "
48138|NCT02936817|"~     Primary:~      The primary objective of this study is to evaluate the effect of the Aerobika® device on the~     aerosol deposition pattern of concomitant inhalation medication using FRI.~      Secondary:~      The secondary objective of this study is to evaluate the effect of the Aerobika® device on~     the airway volume (iVaw), lung and lobe volume (iVlobes), airway resistance (iRaw),~     hyperinflation, airway wall thickness (iVaww), blood vessel density (iVbv), and air trapping~     using FRI.~   "
48139|NCT02936804|"~     The present study is a single arm clinical trial aiming to improve the key technology in the~     diagnosis and treatment of early stage lung cancer. 60,000 high-risk subjects (age 45-70) are~     planned to recruit and assign to the Low Dose Computed Tomography (LDCT) screening arm~     (Baseline + 2 rounds of biennial repeated LDCT screening). Management of positive screening~     test will be carried out by a pre-specified protocol.~   "
48140|NCT02936791|"~     This observational study will collect blood and urine and clinical information from~     individuals with early-stages of polycystic kidney disease (PKD), their unaffected siblings~     and normal volunteers to create a biobank, also called a biorepository. The long-term goal is~     to develop new knowledge on biological markers or biomarkers that indicate changes in the~     disease progression. An understanding of biomarkers for early renal cyst growth will benefit~     PKD patients as new therapies are being developed and tested.~   "
48327|NCT02934360|"~     The TR(ACE) Assay is a quantitative in vitro diagnostic test run on the TR(ACE) Instrument~     intended for the measurement of high molecular weight human DNA from plasma as an aid to~     monitoring disease progression or response to therapy or recurrent or residual disease.~   "
48141|NCT02936778|"~     This study will prospectively assess the impact and relevance of several risk factors for~     children with severe acute asthma (SAA) or acute wheeze that have been identified in~     retrospective studies. Secondary we will assess short-term medical and psychosocial~     functioning in patient (and parents) admitted to a PICU for SAA/acute wheeze versus a control~     group admitted to a MC for SAA/acute wheeze.~   "
48142|NCT02936765|"~     This is an investigator-initiated study. The primary goal is to evaluate the efficacy of two~     different cervical disc devices (prosthesis vs rigid spacer) with respect to postoperative~     change in neck disability index. The evaluation will include clinical and radiological~     parameters.~   "
48143|NCT02936752|"~     This phase Ib trial studies the side effects and best dose of entinostat when given together~     with pembrolizumab in treating patients with myelodysplastic syndrome after deoxyribonucleic~     acid (DNA) methyltransferase inhibitor (DNMTi) therapy failure. Entinostat may stop the~     growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal~     antibodies, such as pembrolizumab, may interfere with the ability of cancer cells to grow and~     spread. Giving entinostat together with pembrolizumab may work better in treating patients~     with myelodysplastic syndrome after DNMTi therapy failure.~   "
48144|NCT02936739|"~     This is an investigator-initiated study. The primary goal is to evaluate the efficacy of two~     different cervical disc prosthetic devices with respect to postoperative change in neck~     disability index. The evaluation will include clinical and radiological parameters.~   "
48145|NCT02936726|"~     There is evidently great potential in implementing workplace health promotion programs, but~     more randomized trials are needed to determine which interventions are worksite-effective in~     helping to decrease inactive behaviors and increase engagement in healthy lifestyle~     activities. For employers, it could mean improving the health and productivity of employees.~     For workers, especially those in physically and/or psychologically demanding positions, it~     could mean developing strength, muscular endurance and agility to reduce musculoskeletal pain~     while developing the stress reduction skills that reduce long-term sickness and absenteeism~     risks. While changing behavior in a complex workplace is, as seen in multiple studies,~     difficult due to the need to change workplace and organizational culture between employers~     and employees, this study aims to identify the effectiveness of workplace interventions in~     relation to counseling for university employees to increase overall work fitness without~     affecting any hierarchal interactions at the work site. Simply put, the investigators will~     examine the benefits of a workplace exercise and mindfulness (two-prong) intervention (in~     combination) vs. a group who just receive a workplace exercise intervention. Both~     interventions will be guided by health coaches. Given the limited research with health~     coaching and workplace interventions for university workers, the aim is to contribute to a~     developing research literature. This study is geared to engage university employees at their~     workplace over a 3 month period. Participants will be assessed through pre and post physical~     and psychological measures and will also undergo semi-structured interviews (SSI).~   "
48146|NCT02936713|"~     To select among different dietary and clinical conditions the most appropriate to assess the~     impact of a fermented milk product on gas-related symptoms~   "
48147|NCT02936700|"~     Suicidal behaviors (SB) are a major health problem in France:10,000 suicides and 220,000~     suicide attempts every year. SB management is therefore a major public health issue.~     Recently, investigators have demonstrated the interest of acceptance and commitment therapy~     (ACT) as an add-on treatment to reduce intensity and severity of suicidal ideation in~     depressed patients having a history of suicide attempt within previous year (i.e actual SB~     disorder according to the Diagnostic and Statistical Manual of Mental Disorders, fifth~     edition (DSM-5)). Based on structural and functional findings, it is admitted orbitofrontal~     and ventral prefrontal cortices play a role in suicidal vulnerability. Interestingly,~     previous functional MRI (fMRI) studies have also reported the modulation of these regions by~     ACT in subjects suffering from chronic pain. fMRI could thus be an interesting tool to~     identify biomarkers of SB and its improvement by ACT.~      The aim of study is to investigate neural biomarkers of ACT efficiency in patients with SB~     disorder. Patients having a history of SB within previous year were randomized in an ACT~     program (21 patients) or relaxation program (21 patients) during 7 weeks. Before and after~     the completion of the group, they performed 3 tasks during fMRI: implicit emotional~     visualization, Cyberball game, motivational task Investigators will compare cerebral~     activations between groups, between pre and post intervention as well as measure baseline~     cerebral activations associated with improvement of suicidal ideation during follow up.~   "
48148|NCT02936687|"~     The objective of this study is to identify insulin-specific cerebral blood flow (CBF) control~     mechanisms, and establish cerebrovascular responsive baseline in younger (18-45 yrs)~     metabolic syndrome adults (MetSyn) who are at substantial risk of stroke and other types of~     cardiovascular mortality even if they never develop diabetes. The central hypothesis is that~     vasodilator actions of insulin are impaired in MetSyn due to loss of dilator and gain of~     constrictor signals. This study will focus on 2 mechanisms that likely limit CBF in MetSyn:~     1) Disruption of nitric oxide (NO) vasodilation, and 2) Exaggerated endothelin (ET-1)~     constriction. Three specific aims will be addressed: Aim 1: To test the hypothesis that~     physiologic surges of insulin acutely increase CBF in young adults, but adults with MetSyn~     exhibit paradoxical insulin-mediated vasoconstriction. Aim 2: To test the hypotheses that key~     mechanisms responsible for poor CBF in MetSyn are shifts in NO and ET-1 signaling.~     Specifically, in healthy controls, NO mediates robust dilation, with little to no ET-1~     constriction. In contrast, adults with MetSyn exhibit uncoupled NO synthase (NOS) and~     exaggerated ET-1 constriction. Aim 3: To test the hypothesis that insulin regulation of CBF~     is regionally distinct (e.g. Middle Cerebral Artery (MCA) reactive than Anterior Cerebral~     Artery (ACA) or basilar), and the negative effects of insulin resistance (IR) are similarly~     regionally specific.~   "
48149|NCT02936674|"~     The purpose of this study is to examine the effects of complex, broad-band spectra light on~     the production of melatonin in humans.~   "
48150|NCT02936661|"~     It is a multicenter randomized, double-blind and placebo-controlled trial. Totally 6500 women~     to delivery by cesarean section will be recruited in this study. In addition to routinely~     oxytocin, the women in study group will receive TXA 1 g in 2 minutes after they delivered~     their babies, and those in control group will receive placebo. The incidence of postpartum~     hemorrhage, the amount of bleeding, as well as the side effects will be observed.~   "
48151|NCT02936648|"~     The VISN1 VA Hepatitis C Testing and Linkage to Care Quality Improvement project aims to: (1)~     increase the proportion of Veterans tested for HCV in those born between 1945-1965 and in~     vulnerable, high-risk groups, (2) Increase linkage to specialized HCV care among VISN 1 VA~     Veterans diagnosed with HCV infection, and (3) Evaluate whether race, ethnicity, gender, or~     other markers of social disparity influence completion of HCV testing and linkage to~     specialty care, and whether disparities are reduced by the planned VISN 1 VA HCV Quality~     Improvement (QI) program. The central focus is to reduce delays in diagnosis and linkage to~     treatment evaluation, management of comorbidities and contraindications, and subsequent~     initiation.~   "
48152|NCT02936635|"~     The purpose of this study is to assess the long-term safety and tolerability of tirasemtiv in~     patients with ALS.~   "
48153|NCT02936622|"~     This randomized multi-center study is intended to compare different coatings on stents for~     treatment of lesions of the above-the-knee femoropopliteal artery.~   "
48154|NCT02936609|"~     This innovative and timely study will measure the impact of Affordable Care Act (ACA)~     Medicaid expansions on cancer screenings and preventive services. To assess this natural~     policy experiment, the investigators will use electronic health record data from the~     Accelerating Data Value Across a National Community Health Center Network (ADVANCE) clinical~     data research network (CDRN) of the National Patient-Centered Clinical Research Network~     (PCORnet).~   "
48155|NCT02936596|"~     Biochemical response of primary biliary cholangitis-autoimmune hepatitis overlap syndrome~     induced by ursodeoxycholic acid only or combination therapy of immunosuppressive agents~   "
48156|NCT02936583|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
48157|NCT02936570|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
48158|NCT02936557|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
48159|NCT02936544|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
48160|NCT02936531|"~     In this study the investigators aim to identify and characterize a potential~     neurophysiological biomarker by mapping functional networks of brain activity (Brain Network~     Activation, BNA) based on analysis of evoked response potential (ERP) signals in both~     asymptomatic FMR1 premutation carriers and in patients with various stages of FXTAS.~     Additionally correlations will be studied between these BNA scores and demographics (gender,~     age and disease duration) as well as genetic mutation and clinical scores.~   "
48161|NCT02936518|"~     A previously published study (https://www.ncbi.nlm.nih.gov/pubmed/27641715) identified~     breastfeeding improvements following lingual frenotomy and/or maxillary labial frenectomy. In~     the previous cohort, babies were excluded from the study if they had previously undergone an~     attempted frenotomy prior to seeing the P.I. in the office. The proposed study will only look~     at those babies who did undergo a previous frenotomy to determine:~        1. the presence of continued problematic breastfeeding symptoms~        2. if further tongue tie or lip tie release improves those outcomes~   "
48162|NCT02936505|"~     A controlled randomized, open-label, multi-centre study evaluating if an immunosuppressive~     protocol, based on ATG-induction, once daily tacrolimus-dose (Advagraf®), mycophenolate~     mofetil and corticosteroid reduces the incidence of chronic lung allograft dysfunction (CLAD)~     after lung transplantation, in comparison with a standard cyclosporin-based protocol.~   "
48163|NCT02936492|"~     Systemic safety following single and multiple dermal administration of BAY1003803~   "
48164|NCT02936479|"~     This is an open-label, single arm trial in which patient who have ongoing antibody mediated~     rejection of a kidney transplant deemed refractory to maximal medical therapy are given the~     complement inhibitor C1-INH (Berinert) in an effort to protect the graft from ongoing~     antibody mediated injury. A maximum of 5 patients will be enrolled.~   "
48165|NCT02936466|"~     Bipolar disorder is a condition characterized by succession of episodes- manic, hypomanic,~     and depressive episodes. Major risks factors of relapses are poor compliance, sleep disorder,~     and toxics consumption. The aims of psychoeducation programs are to increase compliance and~     knowledge about bipolar disorder. Serious game are supposed, in bipolar disorder, to~     strengthen the efficacy of psychoeducation programs. Bipolife® is a serious game which~     purpose is to help bipolar patients to deal with their conditions, through 3 mains messages :~     to pursue the treatment, to have daily routine and to request the psychiatrist in case of~     relapse.~      This is a multicentric randomized controlled study with two harms parallels. After a classic~     psychoeducation group program, patients are randomized in two groups : interventional group~     and control group with treatment as usual.~      The main objective is to evaluate the observance in the two groups. The other objectives are~     to evaluate daily routine, global functioning, and access to health care. Evaluations are~     realized at one and four months after inclusion visit. Acceptability and satisfaction about~     the serious game Bipolife® will be assessed in the interventional group.~   "
48166|NCT02936453|"~     STIMO is a First-in-Man (FIM) study to confirm the safety and feasibility of a closed-loop~     Epidural Electrical Stimulation (EES) in combination with overground robot assisted~     rehabilitation training for patients with chronic incomplete spinal cord injury (SCI).~      Patients will participate during 8-12 months, during which there will be:~        -  Pre-implant evaluations (6-8 weeks)~        -  Device implantation and stimulation optimization (6-8 weeks)~        -  Overground rehabilitation training with EES (5-6 months). In the period after~          implantation, participants need to be present for testing and training, 4 days per week~          at the CHUV University Hospital in Lausanne (lodging can be provided). It is possible to~          complement the neuro-rehabilitative training at CHUV with training outside the~          rehabilitation room by making use of the Home-use system.~      At the end of the protocol, the study aims to make the patients walk better and faster. As~     this is the first study of its kind, success is not guaranteed. However, the potential~     benefits outweigh the potential risks.~      An optional extension of the study up to 3 years is offered. During this period, the patient~     can continue the training with the Home-use system.~   "
48223|NCT02935712|"~     This study will be a phase I, first time in human (FiH), randomized, single-blind,~     placebo-controlled, SAD study in male patients with T2DM, performed at a single study center.~     The study will consist of 2 parts, (A and B) up to 60 male patients with T2DM aged 18 to 65~     years will be included~   "
48167|NCT02936440|"~     The state of hyperhydration in critically ill patients with acute kidney injury (AKI) is~     associated with increased mortality. Bioelectrical impedance vector analysis (BIVA) appears~     to be a viable method to access the fluid status of critical patients but has never been~     evaluated in critical patients with AKI. The objective of this study is to evaluate the~     hydration status using BIVA in critical patients under intensive care at the time of AKI~     diagnosis and to correlate this measurement with mortality. A sample of 224 patients with AKI~     will be evaluated by BIVA and followed until they are discharged or death in intensive care~     unit and the BIVA vectors will be analysed to define differences in hydration characteristics~     from each group.~   "
48168|NCT02936427|"~     Post-op analgesia is the most important part of early and safe patient recovery in thoracic~     surgery. This is for both humane and patient outcome reasons. Patient outcomes are greatly~     improved with optimal pain control and complications and length of stay are minimized. Most~     post-op thoracic complications are from decreased respiratory effort, failure to clear~     secretions and pulmonary infections from retained sputum with subsequent sequelae. Good~     post-operative analgesia not only prevents these complications but also considerably enhances~     early mobilization and thus, decreased hospital stay and efficient resource allocation. Early~     post-operative pain is also associated with late and chronic post thoracotomy pain syndromes~     which can be debilitating.~      Pain following thoracic surgery is different to the standard surgical incision pain and is~     due to intercostal nerve damage, compression or traction injury to the nerve. This occurs~     with the incision, rib retraction, and is compounded by the on-going need for respiratory~     effort. The approach to managing this pain is multi-modal analgesia. The standard regimen~     stretches from preemptive analgesia and preoperative placement of thoracic epidurals to~     post-op opioid infusions. However, non-invasive pharmacology includes paracetamol, non~     steroidal anti inflammatory drugs (NSAIDs), mild and moderate opioids as well as~     anti-convulsants like pregabalin. However, opioid use has well-known side effects including~     central nervous system (CNS) and respiratory depression which unfortunately delay mobility~     and recovery. This has motivated opioid-sparing strategies.~      The investigators study aims to assess whether the addition of perineural dexamethasone (a~     steroid) to the current practice of local anaesthetic wound catheters increases the efficacy~     and duration of analgesia provided.~   "
48169|NCT02936414|"~     The etiology and pathogenesis of schizophrenia remains unclear. Immune dysfunction hypothesis~     for schizophrenia has attracted increasing attention of the researchers, substantial~     evidences suggested the levels of C-reaction protein and cytokine such as IL-1β, IL-6, TNF-α~     markedly elevated in patients with schizophrenia which may be particularly relevant for the~     cognitive impairment and metabolic disturbance of schizophrenia. In recent years, it has been~     demonstrated the beneficial effects of berberine on regulating lipid and glucose metabolism,~     reducing the proinflammatory status and improving cognition. As the investigators known, the~     report of berberine being used in schizophrenia is rare. This protocol is aim to evaluate~     berberine, as an adjunctive therapy, on inflammatory markers, lipid and glucose metabolism,~     cognition in patients with schizophrenia.~   "
48170|NCT02936401|"~     The purpose of this study is to determine the efficacy of Mindfulness Based Stress Reduction~     (MBSR) to alleviate stress, anxiety, and depressive symptoms, and improve attention among~     patients aged 60 or older who suffer from HIV-associated neurocognitive disorders (HAND) and~     have maximized treatment options.~   "
48171|NCT02936388|"~     Characterisation of effect of SIRT and DSM-TACE as local treatment options for liver~     metastases in patients with advanced uveal melanoma with respect to progression-free survival~     and exploratory comparison of secondary endpoints regarding application, activity, adverse~     effects and impact on quality of life in a randomized study design.~   "
48172|NCT02936375|"~     This study is a 52-week, randomized, open, active-controlled trial of patients with active~     diffused lupus nephritis, to assess the efficacy and safety of a novel chemical synthetic~     agent iguratimod. The subjects will randomly receive iguratimod or cyclophosphamide followed~     with azathioprine, both combined with steroids.~   "
48173|NCT02936362|"~     Bread is the most common grain product in the world, with consumption surpassing 3 billion~     individuals per year. Sourdough whole-grain bread is considered a healthy alternative to~     white, refined-wheat bread.~      This cross-over study will test the effect of consumption of sourdough bread compared to~     white bread following a short dietary intervention period (one week) on multiple clinical~     parameters and gut microbiota.~   "
48174|NCT02936349|"~     Current HHT guidelines recommend CT scan to detect new or recurrent PAVMs after~     embolotherapy. Recent studies using transthoracic contrast echocardiography (TTCE) shunt~     grade for PAVM screening suggest that graded TTCE can accurately predict the size of PAVMs on~     chest CT and their amenability to embolization. This study's purpose is to evaluate whether~     TTCE shunt grade can also accurately predict PAVM size and amenability to treatment in~     patients who are post-embolization.~   "
48175|NCT02936336|"~     Osteoporosis is a serious global health problem, second only to cardiovascular disease.~     Osteoporosis is the most common metabolic bone disease in the elderly population,~     characterized by loss of bone mineral density (BMD) and continuous destruction of bone~     microstructure, especially in postmenopausal women. It gives rise to bone fragility and~     fracture risk. Moreover, as people grow older, falls frequently occur with high severity, and~     nearly 35% to 45% of persons aged 65 or older fall at least once a year. Osteoporotic~     fractures increase mortality, morbidity, chronic pain, and the cost of social care and it~     decreases the quality of life. Here, investigators plan to perform different exercise~     interventions such as circuit exercise, aerobic dance and Tai Chi on the community's older~     adults to evaluate whether exercise intervention could improve the bone mineral density,~     physical fitness, muscle strength or quality of life.~   "
48176|NCT02936323|"~     Protocol PEN-221-001 is an open-label, multicenter Phase 1/2a study evaluating PEN-221 in~     patients with SSTR2 expressing advanced gastroenteropancreatic (GEP) or lung or thymus or~     other neuroendocrine tumors or small cell lung cancer or large cell neuroendocrine carcinoma~     of the lung.~   "
48177|NCT02936310|"~     The primary objective of this proposed one-year (January 01, 2017 to December 31,2017)~     project is to assess whether a mindfulness based intervention('Mindful Living With Stress')~     will be effective at helping nurses caring for HIV/AIDS patients in China to reduce stress.~     Based on the efficacy of previous studies in stress reduction, it is hypothesized that~     'Mindful Living With Stress' will be an effective, feasible and affordable stress reduction~     program in China.~   "
48178|NCT02936297|"~     Non-celiac gluten sensitivity (NCGS) is an emerging clinical entity defined as the presence~     of intestinal and/or extraintestinal symptoms induced by the ingestion or gluten and relieved~     by a gluten free diet (GFD) in patients without celiac disease or wheat allergy. The~     pathologic mechanism of the disorder is unknown, and there are no known biomarkers or~     associated histopathologic findings. In this prospective, randomized controlled trail, we are~     investigating the utility of patient reported symptom questionnaires, as well as stool gluten~     and urine quantification tools in patients with NCGS and healthy controls.~   "
48179|NCT02936284|"~     This study evaluates the effect of a music enhancement program to strengthen the motivation~     to engage in music related behaviors rather than eating in infants who are high in motivation~     to eat. Half the participants will participate in a Music Together Program, while the other~     half will participate in a Play Date control. For both groups, participants will attend 34~     weekly sessions for one year, and 12 monthly sessions the next year, in 4 cohorts.~   "
48180|NCT02936271|"~     The purpose of this study is to evaluate the effectiveness of Vasculera in reducing post~     procedural pain, bruising and edema in the post procedure period for patients diagnosed with~     C2-C5 disease requiring an intervention(s).~      The hypothesis is that Vasculera will reduce post procedural pain, bruising and edema for~     patients requiring an intervention.~      This will be a randomized, double-blind, placebo-controlled study. Vasculera is a specially~     formulated prescription medical food product for the clinical dietary management of the~     metabolic processes of chronic venous insufficiency. Vasculera has limited side effects,~     please see the product insert.~      A total of 110 patients will be enrolled into this study. Patients will be randomized to~     receive Vasculera (Study Product) or placebo. Study Product or placebo will be prescribed as~     one (1) tablet twice a day.~   "
48181|NCT02936258|"~     The aim of this study is to assess the efficacy of MRI-targeted biopsy compared to standard~     of care systematic TRUS guided biopsy in the detection of clinically significant and~     clinically insignificant prostate cancer in men without prior biopsy. The implication of this~     trial is that MRI-targeted biopsy could replace systematic TRUS guided biopsy as the standard~     of care in the diagnosis of prostate cancer.~   "
48182|NCT02936245|"~     Cervical spondylotic myelopathy (CSM) is the most frequent cause of myelopathy in those over~     the age of 50. They claim that surgical treatment of myelopathy, especially of the mild and~     moderate forms, has not shown better results than conservative treatment in the long term,~     and criteria for the indication and the timing of the operation have not been established. In~     order to get some more reliable data, a long-term follow up observational study will be~     started to confirm the effects of long term for conservative treatment.~   "
48183|NCT02936232|"~     The aim of this study is to construct multi-center sepsis registry that can be used for data~     warehousing and clinical research.~   "
48184|NCT02936219|"~     In this Austrian observational study preterm infants born with a birth weight <1500 g and a~     gestational age <32 weeks will be investigated at the neonatal outpatient clinic. Infants~     will be stratified according their feeding regimen (breast, formula and combined feeding) and~     their introduction of solid foods (early complementary feeding group: <17th week of life~     corrected for prematurity, late complementary feeding group: ≥17th week of life corrected for~     prematurity). Nutrient intakes and anthropometric parameters will be assessed at term, 6~     weeks, 12 weeks, 6 months, 9 months and 12 months - all corrected for prematurity and with~     40, 54 and 66 months.~   "
48185|NCT02936206|"~     The purpose of this study is to microscopically examine breast cancer cells of pre-menopausal~     and post-menopausal women before and after exposure to one of the two commonly used breast~     cancer drugs, tamoxifen or fulvestrant.~   "
48186|NCT02936193|"~     The safety and efficacy of Laparoscopy-assisted Pylorus-preserving Gastrectomy (LAPPG) for~     the treatment of early gastric cancer (EGC) remain controversial. The investigators conducted~     a randomized controlled trial to compare LAPPG and laparoscopic distal gastrectomy with D2~     lymph node dissections for EGC.~   "
48187|NCT02936180|"~     Influenza, a vaccine-preventable respiratory disease, is ranked 8th among the causes of death~     in the Canadian population. Among rheumatoid arthritis (RA) patients, the incidence of both~     seasonal influenza and serious influenza-related illness (IRI) are increased. Despite being a~     high priority group targeted for vaccination, the diagnosis of RA and other patient-specific~     factors (i.e. older age, treatment, current smoking) are linked to impaired vaccination~     responses.~      Thus the burden of influenza among people with RA is disproportionally high, and~     interventions to improve responses to influenza vaccination are urgently needed. Strategies~     to optimize protection in another vulnerable group, the elderly, include the use of~     quadrivalent vaccines, higher antigen doses, and adjuvants. A high-dose, trivalent,~     inactivated influenza vaccine (HD-TIV) has recently been shown to have a similar safety~     profile to standard dose vaccine (SD-TIV) with improved immunogenicity and protection in~     adults ≥65 years of age. Whether or not analogous strategies to improve responses to~     influenza vaccine will enhance protection in people with RA is unknown. The investigators~     hypothesize that the use of the HD-influenza vaccine will improve vaccine-induced protection~     (i.e. seroconversion and seroprotection) in people with RA compared to SD-influenza vaccine.~     The investigators propose to conduct a stratified, randomized, modified double blind,~     active-controlled trial to assess immune responses to two commercial influenza vaccines~     containing different antigen doses in individuals with RA.~   "
48199|NCT02936024|"~     Undescended Testis (UDT) is the most common congenital anomaly of the genitalia in boys and~     it is commonly managed by surgical intervention. Patients with intra-abdominal or non~     palpable testis, specifically, are often managed using a laparoscopic assisted orchidopexy, a~     common surgical technique to bring undescended testes down into the scrotum. Evidence in the~     medical literature to support the superiority of either one stage or two stage gubernaculum~     sparing laparoscopic orchidopexy (GSLO) is lacking. Due to this reason, this study focuses on~     the effects of one stage versus two stage GSLO on a patient important outcome: testicular~     atrophy.~   "
48200|NCT02936011|"~     Percutaneous Coronary Intervention (PCI) is increasingly effective to treat Chronic Total~     Occlusion (CTO) lesions in coronary arteries. This trial will examine modern dissection and~     re-entry approaches to treat more complex CTO lesions with the Absorb Bioresorbable Vascular~     Scaffold (BVS).~   "
48253|NCT02935322|"~     The aim of the present study was to study if there are interactions and reduced clinical~     effect between chlorhexidine and fluoride when they are combined in the same mouthrinse.~   "
48188|NCT02936167|"~     In children fluids are supplemented during surgery to provide volume, to maintain blood~     glucose levels, electrolyte balance and to meet the ongoing fluid losses during surgery.~     Fluid replacement during surgery since decades has been based on the Holliday and Segar~     method.These authors proposed that water maintenance in children includes: 100 millilitre~     (ml)/100 kilocalorie (kcal) for the first 10 kg of body weight, 50mL/100 kcal for 11-20 kg~     and 20mL/100 kcal for every kilogram of body weight above 20 kg. The maintenance electrolyte~     requirements of 3 mEq/100 kcal for sodium and 2 mEq/100 kcal for potassium per day, were~     based upon the electrolyte composition of breast and cow's milk. Based on these~     recommendations hypotonic fluid (0.45% saline) was considered as the ideal fluid for~     maintenance in children undergoing surgery.~      Since the past many years there have been many documented cases of hyponatremia after~     administration of hypotonic fluids with potential for serious neurological injury in this~     group of patients.The use of Holliday and Segar's formula to calculate the maintenance fluid~     regimen in postoperative children leads to an overestimation of the volume of fluid needed,~     as there is a low urine output in this period. The postoperative period is at risk for~     non-osmotic secretion of anti-diuretic hormone (ADH), which reduces the ability of kidney to~     excrete free water and carries risk for development of hyponatraemia.Authors in favour of~     hypotonic solutions feel that hyponatremia results from excessive volume of fluid and~     isotonic solutions have risk of hypernatremia, interstitial fluid overload, excessive sodium~     excretion, and hyperchloremic metabolic acidosis.~      Based on the increased incidence of hyponatremia in children undergoing surgery, the~     paediatric anaesthesia societies [Society of Paediatric Anesthesia (SPA), Paediatric~     Anaesthesia Society of Great Britain and European society of Paediatric Anesthesia (ESPA)]~     put forward guidelines for the type and amount of fluid to be administered during~     surgery.Since then normal saline is the commonly used fluid during the perioperative~     period.However recent studies have shown that the use of normal saline is associated with~     development of hyperchloremic metabolic acidosis and poor outcome.~      Ringer lactate (RL) is a commonly used intravenous fluid during surgery and has been found to~     have decreased possibility of producing hyponatremia although it is a slightly hypotonic~     solution.Plasmalyte is an isotonic fluid which has been shown to maintain electrolyte balance~     and prevent hyponatremia as well as hyperchloremic acidosis in adult population.However~     plasmalyte has been less frequently used in paediatric population.Therefore this study is~     planned with the aim of comparing intravenous fluids, ringer lactate and plasmalyte in the~     perioperative period regarding the incidence of hyponatremia produced by these solutions,~     their effect on electrolytes and blood gases in children undergoing elective surgery.~   "
48189|NCT02936154|"~     The purpose of this study is to evaluate the tolerability, safety and pharmacokinetics of~     PF-06650833 orally administered as modified release tablets in healthy Japanese subjects.~   "
48190|NCT02936141|"~     The aim of this project is to describe the mental health status of the homeless people in~     Maputo and Matola utilising standardised clinical and socio-demographic assessments.~     Simultaneously; the study aims to determine the influence of a psychosocial intervention in~     patients with apparent signs of mental illness, aiming at his/her family reintegration; This~     study is conducted hypothesizing that the familial reintegration after intervention would be~     the same across patients with different mental disorders.~   "
48191|NCT02936128|"~     The purpose of this study is to compare the clinical outcomes of TruSkin® and an Active~     Comparator in patients with chronic venous leg ulcers.~   "
48192|NCT02936115|"~     The purpose of this study is to compare the clinical outcomes of TruSkin® and an Active~     Comparator in patients with chronic diabetic foot ulcers.~   "
48193|NCT02936102|"~     The purpose of this first-in-human study of FAZ053 is to characterize the safety,~     tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of FAZ053~     administered Intravenously (i.v.)as a single agent or in combination with PDR001 in adult~     patients with advanced solid tumors.~      By blocking the interaction between Programmed Death Ligand-1 (PD-L1) and its receptors,~     Programmed Death-1 (PD-1) and B7.1, FAZ053 inhibits the PD-L1 immune checkpoint, resulting in~     activation of an antitumor immune response by activating effector T-cells and inhibiting~     regulatory T-cells.~      This study has been designed as a Phase I, open-label, multi-center study with a dose~     escalation part of FAZ053 as single agent and in combination with PDR001, followed by a dose~     expansion part of FAZ053 as single agent and in combination with PDR001.~      FAZ053 will initially be dosed every three weeks. A less frequent dosing regimen such as~     every 6 weeks may be evaluated in parallel.~      A patient may continue treatment with FAZ053 single agent or in combination with PDR001 until~     the patient experiences unacceptable toxicity, confirmed disease progression per immune~     related Response Criteria and/or treatment is discontinued at the discretion of the~     investigator or the patient.~   "
48194|NCT02936089|"~     Acute myeloid leukemia with t(8;21) /AML1-ETO-positive (AE AML) is a heterogeneous disease~     entailing different prognoses. There were significant differences in the therapeutic effect~     between different subgroups of AE AML. Therefore, risk stratification-directed therapy is~     very necessary for AE AML.~   "
48195|NCT02936076|"~     The purpose of this study is to examine the psychological benefits of chronic exercise as~     well as the effects of exercise training on eating behaviors and stress-induced overeating in~     overweight and obese women. Participants will be randomized to an 12-week exercise condition~     or a delayed exercise condition. Assessments will occur at baseline, 6 weeks, and 12 weeks~     and will include answering surveys in real-time using smartphones, several assessments of~     eating behaviors and dietary intake, and questionnaire measures of factors which could~     mediate the relationship between exercise and eating. Participants will be compensated for~     completing assessments and for adherence to the exercise protocol.~   "
48196|NCT02936063|"~     When patients undergo neck dissection surgeries, the current standard of care is to close the~     skin layer with either metal staples, which are removed a few days post-operatively, or with~     sutures, which can be absorbable or removed. To date, there is no conclusive data in the~     literature that definitively suggests one method is better than the other, with regard to~     wound complications or mature scar cosmesis. Currently, skin closure method is chosen by each~     individual surgeon, and is based on personal preference, factoring in evaluation of the~     wound. The goal of the study is to compare the two methods of skin closure, and the measured~     outcomes the investigators will be looking at are patient satisfaction, wound complications,~     and mature scar cosmesis. The investigators will be randomizing patients undergoing head and~     neck surgery to receive either staples or subcuticular sutures, and giving them surveys at~     their post-operative clinic visits to evaluate the outcomes, to determine if patients~     perceive one method to be superior to the other.~   "
48197|NCT02936050|"~     The cost related to management of heart failure is significant, both with respect to the~     financial costs and the suffer of patients. Still as much as 50% of heart failure patients~     are readmitted within 6 months after hospitalization for decompensated heart failure.~      Specialized nurses have a growing role in diagnostics and follow-up of outpatient HF~     patients, and adding ultrasound diagnostics to the nurses consultations may improve care. In~     heart failure patients the use of ultrasound as a tool for assessing volume status and~     guidance of diuretic therapy are promising. Aim of the study is to evaluate the feasibility~     and reliability of echocardiographic acquisitions by heart failure nurses to assess cardiac~     function indices and assess volume status in outpatient heart failure clinics combined with a~     telemedicine approach for near real-time interpretation of the recordings by a cardiologist~     specialized in echocardiography and heart failure at a remote location.~   "
48201|NCT02935998|"~     1. The title of this study is a multi-center,non randomized,open-labeled,intervention~          study:the efficacy and safety of intramuscular ziprasidone for three days in patients~          with acute psychotic agitation.~        2. The primary objectiveis to evaluate the efficacy of intramuscular ziprasidone in~          patients with acute psychotic agitation in daily clinical practice.~        3. The secondary objectives are:1.To evaluate the safety of intramuscular ziprasidone in~          patients with acute psychotic agitation in daily clinical practice.2.To compare the~          efficacy and tolerance of intramuscular ziprasidone in patients with agitation in the~          different psychotic disorder 3.To compare the efficacy and tolerance of intramuscular~          ziprasidone in patients with first episode andmulti-episode patients. 4.To explore the~          measured based administration according to severity of symptoms.5.To compare the~          efficacy and tolerance of ziprasidone im between the monotherapy and combination with~          other antipsychotic drug in clinical practice.~        4. The Rationale:In China, the studies of ziprasidone im treating agitation focus on~          schizophrenia. But in the foreign country, ziprasidone im also is approved to treat~          psychotic agitation, including bipolar and schizoaffective disorder. And in the clinical~          practice of China, ziprasidone im is also used to treat other patients, although the~          evidence is less. In this study, we assume ziprasidone im treat the psychotic agitation~          is effective and safe.~        5. Study populations:The study plan to enroll 1000 subjects in China. （6）The background and~          the hypothesis：The researches of ziprasidone mesylate injection in our country are more~          concentrated in schizophrenia at present, while in foreign countries ziprasidone is~          approved for psychotic agitation, including mania etc. It's also used for substance~          abuse and alcohol induced agitation.Therefore, this study assumes that ziprasidone~          mesylate injection is effective in the treatment of acute agitation, and it's well~          tolerated.~   "
48202|NCT02935985|"~     The bio-markers substudy of EsICH is designed to recruit patients with acute (first 8h)~     spontaneous intracerebral hemorrhage and assess a series of biological parameters (CBC,~     glucose, cholesterol, LDL cholesterol, triglycerides) and point-of-care bio-markers (cTnI,~     hsCRP, D-Dimer) in order to predict the functional outcome of these patients and to determine~     their input for early risk stratification and prognosis.~   "
48203|NCT02935972|"~     Prostate biopsy under transrectal ultrasound (TRUS) guidance is considered the procedure of~     choice for diagnosing prostate cancer. And as in any other diagnostic biopsy procedures;~     patients perceive anxiety before, during and after biopsy and ultrasound guided prostate~     biopsy is not an exclusion.~      TRUS guided prostatic biopsies are mainly performed in an outpatient clinic, men undergoing~     transrectal prostate biopsy experience considerable psychological stress. It may be~     attributable to the fear of the potential diagnosis of cancer, the anal route of penetration,~     the fact that the subject organ examined is part of the sexual system and the anticipated~     pain and as a matter of fact the issues of discomfort and pain perceived throughout the~     procedure referred to the negative impact of the whole procedure, that is probe insertion and~     biopsy punctures.~      Thus it is essential to employ a simple method that can liberate the patient from pain during~     prostate biopsy. Some studies recommend sedation , others recommend intra-rectal lidocaine~     gel and others periprostatic nerve block while others recommend Nitrous oxide inhalation as~     an effective method of analgesia for the procedural related pain or discomfort of prostate~     biopsy. The employment of analgesics, sedation and/or narcotic medication may alleviate much~     of the discomfort associated with transrectal prostate biopsy, such treatment may be~     associated with additional risks. Furthermore, when systemic medication is administered,~     patients require conscious sedation monitoring during and after the procedure, which may be~     inconvenient and relatively expensive in addition to their unsuitability to be performed on~     outpatient clinic basis. Therefore, a simple form of anesthesia is desirable.~      Although a wide variety of anesthetic techniques are available for transrectal~     ultrasound-guided prostate biopsy, including rectal administration of lidocaine gel,~     periprostatic nerve blocks, intravenous propofol, and narcotic intramuscular premedication,~     these methods may not optimally prevent or relieve pain.~   "
48204|NCT02935959|"~     Evaluate the efficacy of nebulized dexmedetomidine, nebulized ketamine, and nebulized~     midazolam a premedication prior to general anesthesia (GA) in oncologic preschool children~     undergo bone marrow aspirate and biopsy.~   "
48205|NCT02935946|"~     A previous study revealed that dysphagia preterm infants show statistically significant~     improvements in their swallowing mechanism when fed cold liquid barium when compared to room~     temperature liquid barium. The previous study was the first to identify these positive~     effects, although, only assessed 5 cold liquid swallows, immediately after the room~     temperature condition. This limited data set restricts the efficacy and safety of using cold~     liquids in clinical practice, emphasizing the need for further information. The present study~     aims to objectively assess the influence of cold liquid on the pharyngeal swallow mechanism~     in preterm infants with dysphagia after 10 minutes of a cold liquid feeding. The~     investigators will utilize videofluoroscopic swallow studies (VFSS) to analyze the frequency~     and severity of pharyngeal swallowing deficits during room temperature swallows and compare~     it to cold liquid swallows at various time points within a 10 minute feeding. Safety measures~     will also be obtained, such as participant axillary body temperature and gastric content~     temperature, to identify indicators for the development of cold stress.~   "
48206|NCT02935933|"~     Evaluate the effect of addition of morphine, dexmedetomidine to bupivacaine in PVB could~     improve the analgesic effect and thus reduce postoperative morphine consumption and~     development of chronic neuropathic pain, compared to PVB with bupivacaine , in patients~     undergoing major breast cancer surgery, i.e., modified radical mastectomy (MRM) and breast~     conservation surgery with axillary lymph node dissection.~   "
48207|NCT02935920|"~     Background:~      In February 2015 the Danish Health and Medicines Authority published new clinical guidelines~     describing how cancer patients should be followed. It is recommended that patients receiving~     specific oncological treatment such as endocrine therapy be followed at the department of~     oncology responsible for the treatment and providing the medication. There is no evidence~     that routine examinations improve overall survival after breast cancer. Mammography is the~     only specific examination to be offered to asymptomatic women after treatment for breast~     cancer~      Aims of the study:~      The hypothesis is that individualized follow-up with the introduction of Patient Reported~     Outcome (PRO) data will help postmenopausal women regain control of health related self-care~     and encourage them to a larger extent to take part in their follow-up after cancer treatment.~     This is believed to improve the health related quality of life and increase the positive~     experience of the follow-up program.~      Design:~      Patients are randomly assigned to the department's standard control program or an~     individualized solution in the context of shared decision making. PRO data will be used to~     evaluate the patient's need for consultations.~      Primary outcome:~      Evaluation of the experience and feasibility of PRO data in connection with individualized~     follow-up of postmenopausal women with breast cancer. Systematically applying PRO data we~     will uncover patient needs, empower the patients to take part in shared decision making, and~     improve the current follow-up in the sense of a more patient-centered care and tailored~     follow-up.~   "
48208|NCT02935907|"~     APG-115 is a novel, orally active small-molecule mouse double minute 2 homolog (MDM2)~     inhibitor. Mechanistically, APG-115 increases p53 and p21 overexpression, activates p53 -~     mediated apoptosis in tumor cells retaining wild-type p53. APG-115 has shown strong dose- and~     schedule-dependent antitumor activities in multiple human cancer xenograft and a patient~     derived xenograft (PDX) models. The preclinical data generated from APG-115 suggest that it~     may have a broad therapeutic potential for the treatment of human cancer as a single agent~     and in combination with other classes of anticancer drugs. APG-115 is intended for the~     treatment of patients with advanced solid tumors and lymphomas. Upon completion of the Phase~     1 dose escalation study to establish the maximum tolerated dose (MTD), dose-limiting~     toxicities (DLTs), and/or recommended phase 2 dose (RP2D), several phase Ib/II studies will~     be implemented accordingly.~   "
48209|NCT02935894|"~     The purpose of this study is to see what the differences are in sweat (amount and small~     molecule content) collected from different sites of the body and by different methods of~     sweat stimulation. Additionally, the investigators want to know whether the amount and small~     molecule content of the sweat is the same in an individual over time, and the same across~     individuals at a given time. Finally, the investigators want to know how consumption of~     over-the-counter anti-inflammatory drugs such as ibuprofen will affect the inflammatory~     mediator content of sweat and how that compares to blood. This information will help to~     better understand the composition and behavior of sweat and assess its potential utility as a~     routine clinical tool in skin research.~   "
48210|NCT02935881|"~     Gastro-esophageal reflux disease (GERD) is a chronic disorder with significant impact on the~     quality of life of patients. It may also lead to several complications like peptic~     strictures, ulcerations, Barrett 's disease and subsequently adenocarcinoma of the esophagus.~     Proton pump inhibitors (PPIs) are the mainstay of GERD treatment, with up to 90 % of patients~     with reflux disease becoming asymptomatic while taking PPIs. Several studies have~     demonstrated that RF delivery at the gastro-esophageal junction(GEJ), also called the Stretta~     procedure, induces symptom relief and decreases need of PPI intake in GERD. The investigators~     propose to perform a sham-controlled randomized study to evaluate the influence of the~     Stretta procedure on symptoms and esophageal acid exposure in patients of refractory GERD.~   "
48211|NCT02935868|"~     Diabetes Mellitus is a risk factor for periodontal disease increasing its prevalence,~     extension and severity. Periodontal disease is considered the sixth complication of diabetes.~     There is a global epidemic of diabetes, including an increase of incidence of type 1 diabetes~     in younger patients. Thus, the aim of this observational study was to evaluate the~     periodontal and salivary condition of a sample of patients with type 1 diabetes of a~     brazillian city.~   "
48212|NCT02935855|"~     Diabetic and nondiabetic patients will be evaluated if they had a first diagnosis of~     non-valvular atrial fibrillation and in therapy with non-vitamin K oral anticoagulants and~     with vitamin K oral anticoagulants.~   "
48213|NCT02935842|"~     Due to Parkinson's Disease (PD) speech and language (SL) deficits may occur. Further, the~     literature reports that PD patients, who have not undergone deep brain stimulation (DBS),~     have deficits regarding voice quality (e.g. loudness and intelligibility of their voice),~     while PD patients who have undergone DBS suffer from deficits in word retrieval and speech~     apraxia symptoms. To-date, therapeutic approaches focusing specifically on SL deficits~     observed in PD-DBS patients are yet to be developed and evaluated.~      Therefore, this study investigates the short-and longterm effectiveness of specific and~     intensive, high-frequency speech-language therapy in terms of reducing SL-deficits compared~     to a nonspecific and non-verbal sham treatment (i.e. a rhythmic balance-movement training~     (rBMT)) as well as to a 'no-therapy' condition.~   "
48214|NCT02935829|"~     This study investigated any potential associations between two preloads offered as snacks and~     postprandial glycemic response, subjective and objective appetite and energy intake in~     healthy, normal-weight adults.~   "
48215|NCT02935816|"~     The investigator prospectively compare diagnostic concordance of whole body~     multi--‐parametric Magnetic Resonance Imaging (MRI) with current conventional~     multi--‐modality reference standard imaging (CT scan, isotope bone scan +/--‐ PET--‐CT scan)~     for staging of prostate cancer patients with biochemical relapse following external beam~     radiotherapy or brachytherapy of locally advanced prostate cancer.~   "
48216|NCT02935803|"~     An increasing number of specific procedures have been described for the surgical repair of~     pelvic organ prolapse (POP) and concomitant stress urinary incontinence (SUI). The~     investigators introduced an alternative operative method for POP-Q II-III repair and~     anti-incontinence with the trans vaginal mesh (TVM) anterior edge fixed to the periurethral~     tissues at the level of mid-urethra. The efficacy and short- and long-term complication~     profile, of this new surgical technique as compared with those of non-modified TVM.~   "
48217|NCT02935790|"~     Determine the safety, tolerability, dose-limiting toxicities (DLTs), maximum tolerated dose~     (MTD), and recommended Phase 2 dose (RP2D) of ACY-241 in combination with ipilimumab and~     nivolumab in patients with unresectable Stage III/Stage IV melanoma.~   "
48218|NCT02935777|"~     The double-blinded, randomised, placebo-controlled crossover pilot study is conducted as a~     two week intervention after a pre-intervention registration and preparation period.~      This study explores whether acute supplementation with pomegranate extract can modulate~     indicators of cognitive function and mood in healthy adults. Changes in physiological and~     biochemical markers are also investigated.~   "
48219|NCT02935764|"~     This study is designed to compare the efficacy and safety of FOLFIRI regimen with irinotecan~     monodrug in the treatment of advanced colorectal cancer patients in the second-line setting.~   "
48220|NCT02935751|"~     The ADIOS study is a prospective, observational study will evaluate one hundred and thirty~     (130) patients with non-valvular atrial fibrillation who are currently receiving treatment~     with apixaban as indicated to reduce the risk of stroke or systemic embolism, and who require~     an elective major surgical or invasive procedure will be included in the study. The purpose~     of the study is to evaluate the efficacy of the recommended pre-procedure washout period of~     48 hours.~   "
48221|NCT02935738|"~     Corticosteroids have been indicated to treat men with ASAs. Although many studies have~     confirmed the clinical therapeutic significance of corticosteroids in the treatment of men~     with ASAs, other studies have not found a therapeutic significance for corticosteroids in the~     treatment of men with ASAs. Moreover, although some reports have shown high fertilization and~     conception rates in couples when husbands did not have ASAs, other reports have shown that~     ASAs do not have a negative effect on fertilization and conception rates. These contradictory~     results have left the therapeutic effect of corticosteroids in men with ASA in continuing~     controversy. This controversy is also extended to include the usefulness of assisted~     reproductive technology (ART) in the treatment of patients with ASAs. In this regard,~     although some studies have shown that the pregnancy rate following in vitro fertilization~     (IVF) or intracellular sperm injection (ICSI) were similar in men with or without ASA or did~     not associate with ASA, others reported the superiority of ICSI over IVF and intrauterine~     insemination over natural intercourse in men with ASAs. It is possible that some patients~     with ASAs also have an additional problem(s) related to sperm binding to the oolemma and~     fusion into the ovum as well as sperm head decondensation. The latter condition may~     negatively influence or mask the clinical significance of corticosteroids on pregnancy rates~     in patients with ASAs. Some patients might not have benefited from corticosteroids and~     conventional IVF treatments due to the impaired sperm fusogenic capacity in addition to ASAs.~     Human sperm penetration assay (SPA), of the hamster oocyte free from zona pellucida, is a~     sensitive tool that can address such potential impairment of sperm binding with the oolemma~     and fusion into the oocyte as well as sperm head decondensation. Males with poor SPA results~     benefit from ICSI whereas those with good SPA results can still benefit from conventional~     IVF.~      The present study was therefore conducted to address the therapeutic usefulness of a~     corticosteroid named prednisolone in the treatment of immunologically infertile men~     undergoing IVF or ICSI determined by SPA.~   "
48224|NCT02935699|"~     This will be a multicenter, parallel group, randomized, double-blind, active controlled,~     Phase III clinical study of cetirizine injection, 10 mg/mL, compared to diphenhydramine~     injection, 50 mg/mL (Benadryl or generic equivalent), in approximately 256 patients (1:1~     ratio) with acute urticaria requiring treatment in Emergency Departments, hospitals, Urgent~     Care Centers, Allergy Clinics, and etc.~   "
48225|NCT02935686|"~     The primary purpose of this study is to assess safety/tolerability of the different vaccine~     regimens and to assess envelope (Env)-binding antibody (Ab) responses of the 2 different~     vaccine regimens.~   "
48226|NCT02935673|"~     The purpose of this study is to characterize the Pharmacokinetic and to confirm the popPK~     model derived from healthy volunteers in hospitalized adults who are infected with~     respiratory syncytial virus (RSV) and to determine in adults who are hospitalized with~     respiratory syncytial virus (RSV) infection the dose response relationship of multiple~     regimens of lumicitabine on antiviral activity based on nasal RSV shedding using quantitative~     real-time reverse transcriptase-polymerase chain reaction (qRT-PCR) assay.~   "
48227|NCT02935660|"~     Mult-center study to evaluate the safety and efficacy of an investigational version of the~     Cutera enlighten laser that offers multiple wavelengths for tattoo removal~   "
48228|NCT02935647|"~     This study is designed to determine if the antidepressant effects of deep anesthesia via~     propofol are related to EEG burst suppression.~   "
48229|NCT02935634|"~     The purpose of this study is to determine whether Nivolumab in combination with other~     therapies is more effective than Nivolumab in combination with Ipilimumab in treating~     patients/subjects with advanced gastric cancer.~   "
48230|NCT02935621|"~     The central aim of this proposed study is to test a multimodal, mindfulness-oriented~     intervention designed to disrupt the risk chain leading to prescription opioid dose~     escalation, opioid misuse and opioid addiction, which are mounting threats to active duty~     service members and Veterans with chronic pain conditions, who may develop disordered opioid~     use as a consequence of long-term opioid pharmacotherapy.~   "
48231|NCT02935608|"~     The primary objective of the study is to evaluate the efficacy of two dose regimens of~     BIIB074 on neuropathic pain in participants with pain from lumbosacral radiculopathy (PLSR).~     Secondary objectives are to evaluate the efficacy of 2 dose regimens of BIIB074 on additional~     neuropathic pain measures and assessments of low back pain, disability, and quality of life;~     To investigate the safety and tolerability of 2 dose regimens of BIIB074 and To characterize~     the pharmacokinetics (PK) of BIIB074 in this population.~   "
48232|NCT02935595|"~     The primary goal of the project is to study the effect of Ketamine on cortical~     neurophysiological function in TRD patients. The proposal employs robust and non-invasive~     neurophysiological techniques TMS and EEG to investigate the cortical excitability and~     oscillatory activity in patients with treatment resistant depression.~   "
48233|NCT02935582|"~     Multinational real-life study of current psoriasis treatment strategies, topical treatment~     patterns and treatment outcomes of these treatments, including the newly introduced~     calcipotriol/betamethasone dipropionate aerosol foam fixed combination product Enstilar®~     (calcipotriol/betamethasone dipropionate).~   "
48234|NCT02935569|"~     This study hypothesizes that in patients undergoing whole brain radiotherapy, a compression~     headband will decrease the percentage of patients with significant hair loss following~     radiation.~   "
48235|NCT02935556|"~     This study will recruit women with post partum pre-eclampsia and match them to controls~     without postpartum pre-eclampsia to identify an epigenetic signature that is specific to~     women with post partum pre-eclampsia to help characterize the underlying pathophysiology of~     post partum pre-eclampsia.~   "
48236|NCT02935543|"~     This is a single center, single arm, open-label phase 2 study to determine the efficacy of~     autologous T cells expressing CD19 chimeric antigen receptors expressing tandem TCRζ and~     4-1BB (TCRζ/4-1BB) co-stimulatory domains (referred to as CART19 cells) in adults with~     minimal residual disease (MRD) during upfront treatment for CD19+ acute lymphoblastic~     leukemia.~   "
48237|NCT02935530|"~     Venous thromboembolism (VTE) is an important cause of post-operative morbidity and mortality~     in women undergoing surgery for gynecologic malignancies. Although the benefit of~     thromboprophylaxis in reduction of post-operative VTE events after surgery for gynecologic~     cancers has been well documented around the world, the evidence for Chinese women is rare.~     The investigators designed this prospective and randomized study to assess the benefit of~     pharmacologic prophylaxis for patients received surgical treatment for gynecologic~     malignancies in China.~   "
48238|NCT02935517|"~     This will be a non-randomized, open-label, Phase 1/2 study of the safety and efficacy of~     AGTC-402, administered to one eye by subretinal injection in individuals with achromatopsia~     caused by mutations in the CNGA3 gene. The primary study endpoint will be safety and the~     secondary study endpoint will be efficacy.~   "
48239|NCT02935504|"~     The primary goal of this study is to evaluate the PRogram In Support of Moms (PRISM) that~     aims to improve women's access to and participation in perinatal depression treatment and~     thereby improve depression outcomes~   "
48240|NCT02935491|"~     Transcatheter Aortic Valve Implantation (TAVI) indications are progressing rapidly as an~     alternative to conventional surgery for aortic stenosis cure. Despite a high rate of~     procedural success, some patients do not benefit from the procedure. The investigators~     hypothesis is that aortic stiffness may be of major prognostic significance after stenosis~     relief.~      The aim of this study is to test the prognostic impact of aortic stiffness estimated by the~     volume of calcifications of the thoracic aorta on the CT-scan performed systematically before~     the procedure. This prognostic value will be assessed in 4 independent cohorts issued from 4~     french cities (Lyon, Rouen, Paris, Clermont-Ferrand).~   "
48241|NCT02935478|"~     Hepatocellular carcinoma (HCC) is the most common primary malignant liver tumor and has a~     grave prognosis. Obesity is an epidemic in the US.Patients with HCC and obesity are not~     candidates for liver transplantation, depriving them of the best option for cure from HCC.~      Recent studies have shown that blocking blood vessels to a particular portion of the stomach~     (bariatric or left gastric artery embolization) can temporarily decrease levels of the~     appetite inducing hormone ghrelin, and result in weight loss.The purpose of this study is to~     determine if Left gastric artery embolization (LGAE) in patients with cirrhosis and HCC who~     are not transplant candidates due to morbid obesity, leads to clinically significant weight~     loss with eligibility for liver transplantation.~   "
48242|NCT02935465|"~     The overarching aim of this project is to conduct a randomized controlled study to determine~     whether Mindfulness-Oriented Recovery Enhancement (MORE) vs. a Support Group (SG) can improve~     pain regulation and hedonic functions (i.e., natural reward responsiveness) thought to be~     governed by the endogenous opioid system among opioid-treated, chronic, non-neuropathic back~     pain patients (CNBP) and thereby improve clinical pain, affect, and opioid use.~   "
48243|NCT02935452|"~     The Generating Engagement in Network Involvement (GENIE) Tool is designed to support people~     to find and join social activities in their own neighbourhoods.~      Evidence has shown that people with more social support have increased ability to manage long~     term conditions and ill health.~      Patients with Chronic Obstructive Lung Disease (COPD) have difficulty breathing every day;~     this is both tiring and makes its difficult to socialise as they did prior to having their~     condition. COPD can be managed with medicines, and exercise, but will never be cured, so it~     is considered a 'long term condition.'~      This study plans to use a social mapping tool (GENIE) with COPD patients that are already~     part of the community service. The aim of the study is to increase opportunities to socialise~     and get day to day support outside of the health service.~      Patients will be offered either the tool, or usual care.~      If the study is successful then use of health care may reduce in the COPD patients already~     using the COPD service.~   "
48244|NCT02935439|"~     The purpose of this research study is to learn about the use of a cell phone for monitoring~     patients with heart failure. Participants will be asked questions about their heart failure~     daily and participants will need to answer them. The investigator will try to assess if the~     questions are easily understood by the participants. The investigator will also assess if the~     phone-based system for monitoring is easy to use by the participants. The investigator will~     also assess if the daily questions and interactions increase the self-efficacy, knowledge,~     and quality of life of participants related to their heart failure.~   "
48245|NCT02935426|"~     Cyanoacrylate tissue adhesives have been successfully used for wound closure. The purpose of~     this clinical trial is to compare cyanoacrylate tissue adhesives to polytetrafluoroethylene~     (PTFE) sutures in the donor site of connective tissue grafts. Two groups of volunteers will~     randomly assigned to one of the two study groups. The wound closure at the palatal donor area~     will be achieved with polytetrafluoroethylene (PTFE) sutures in one group and with high~     viscosity cyanoacrylate tissue adhesives on the other group. The surgical procedure will be~     performed by one of three calibrated periodontics residents. Data will be collected at~     baseline-day of the surgery and in one week post-operatively. The primary outcome is~     patient's discomfort from the donor site during the first week after the surgery. Secondary~     outcomes is the time required for suture placement or cyanoacrylate application, patient's~     pain from donor and recipient site one week post-operatively, painkillers intake, presence or~     absence of inflammation and modified EHI early-wound healing index.~   "
48246|NCT02935413|"~     The purpose of this Study is to determine whether non-invasive transcranial direct current~     stimulation (tDCS) is effective in increasing rehabilitation effects after stroke in visual~     Cortex.~   "
48247|NCT02935400|"~     The long term objective of the research is to identify new biomarkers of disease activity in~     the human acute porphyrias. This pilot study is intended to provide pilot and feasibility~     data needed to plan larger and more definitive future studies.~   "
48248|NCT02935387|"~     Rheumatoid arthritis (RA) patients in remission with a combination of TNFinhibitors (TNFi)~     and methotrexate (MTX) often express their wish to stop MTX treatment because of side~     effects. Given the efficacy of TNFi it is conceivable that in early RA patients in remission~     with methotrexate (MTX)/TNFi stepwise discontinuation of MTX prior to TNFi is superior in~     maintaining sustained remission and reaching drug free remission as compared to~     discontinuation of TNFi prior to MTX.~      Objective: To investigate whether tapering MTX first, then the TNFi golimumab (GOL), is more~     efficacious than tapering GOL first, then MTX, in sustaining remission and reaching drug free~     remission.~      Study design: multicenter, open label clinical trial in very early RA patients. Remission~     will be induced by an open label treat-to-target (T2T) remission induction protocol in~     clinical care: (MTX, hydroxychloroquine (HCQ), i.m. glucocorticoids (GC), and, if not in~     remission, the TNFi golimumab (GOL)) (phase I, 3/4th or 1 year). Patients in sustained~     remission on MTX/GOL (DAS28<2.6 with max 4 swollen joints of the 44 swollen joint count (SJC)~     at 2 consecutive visits 3 months apart) will be randomized to taper either MTX first, then~     GOL or GOL first, then MTX with as primary endpoint sustained (drug free) remission (phase~     II, 1 year). During 1 year additional follow-up maintenance of drug-free sustained remission~     will be investigated (phase III).~      Study population: RA patients fulfilling 2010 American College of Rheumatology (ACR)/EUropean~     League Against Rheumatism (EULAR) criteria for RA, with symptom duration <12 months; naïve~     for anti-rheumatic drugs and glucocorticoids for RA; DAS28 ≥3.2.~      Intervention: Patients in sustained remission (defined as DAS28<2.6 with max 4 swollen joints~     of the 44SJC at ≥ 2 consecutive visits 3 months apart) on MTX/GOL at the end of phase I~     (after 24 weeks of treatment with MTX/GOL) will be randomized in a ratio of 1:1 to taper~     medication as follows:~        -  Taper and stop GOL first during 24 weeks, then, if still in sustained remission, taper~          and stop MTX during 24 weeks~        -  Taper and stop MTX first during 24 weeks, then, if still in sustained remission, taper~          and stop GOL during 24 weeks The primary end point is the proportion of patients in~          sustained remission at week 24 after start of tapering of either MTX or GOL first. The~          main secondary end point is the proportion of patients in drug-free sustained remission,~          at week 48 after start of tapering.~   "
48249|NCT02935374|"~     This is a randomized, controlled trial studying the effects of various antimicrobial~     treatments on the intestinal microbiome of small children. The participating children with~     acute otitis media are treated wither with amoxicillin, amoxicillin-clavulanate or without~     antibiotics. The children with allergy to amoxicillin receive a course of macrolide and they~     will be monitored as a separate group. The main outcomes of this trial are the changes in the~     intestinal microbiome after the treatment.~   "
48250|NCT02935361|"~     This phase I/II trial studies the side effects and best dose of guadecitabine when given~     together with atezolizumab and to see how well they work in treating patients with~     myelodysplastic syndrome or chronic myelomonocytic leukemia that has spread to other places~     in the body and has come back or does not respond to treatment. Guadecitabine may stop the~     growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal~     antibodies, such as atezolizumab, may interfere with the ability of cancer cells to grow and~     spread. Giving guadecitabine and atezolizumab may work better in treating patients with~     myelodysplastic syndrome or chronic myelomonocytic leukemia.~   "
48251|NCT02935348|"~     Children and adolescents with Hodgkin lymphoma currently undergo multiple investigations~     including a separate PET and MRI scans during their treatment.~      Investigators want to investigate if a combined PET-MRI scan could give the same information.~      Children who join our study will have an extra scan twice during their treatment~   "
48252|NCT02935335|"~     AME is a non-interventional, prospective, longitudinal and multicenter study. This study aims~     to measure the relationship between antimüllerian hormone serum level (AMH), as measured by a~     fully automated assay and the initial dose of Menopur® HP-hMG 600 IU/mL prescribed for~     infertile women undergoing their first IVF/ICSI cycle in the current practice.~   "
48255|NCT02935296|"~     The purpose of this study is to determine the feasibility of a future trial that will assess~     whether an integrated intervention combining psychosocial counseling and supported referrals~     for antiretroviral therapy (ART) at any CD4 cell count and substance use treatment for~     HIV-infected people who inject drugs (PWID) will reduce HIV transmission to HIV-uninfected~     injection partners, as compared to routine care dictated by national guidelines for~     HIV-infected PWID.~   "
48256|NCT02935283|"~     In proximal urea cycle disorders (UCD), particularly ornithine transcarbamylase deficiency~     (OTCD), hyperammonemia (HA) causes increased brain glutamine (Gln) which perturbation is~     thought to be at the core of the neurological injury. In contrast, in distal UCD such as~     citrullinemia (argininosuccinate synthetase deficiency; (ASSD) and argininosuccinic aciduria~     (argininosuccinate lyase deficiency); (ASLD) cognitive impairment and neuropsychiatric~     disease are common even in the absence of acute HA. As a consequence, both citrulline and~     argininosuccinate (ASA) or their metabolic products have been implicated as neurotoxic. In~     this project the investigators will use state-of- the-art neuroimaging and neuropsychological~     methods to investigate whether patients with OTCD have chronically elevated brain Gln and~     reduced myo-inositol (mI) levels that correlate with regional brain structural abnormalities~     and neurocognitive dysfunction. The researchers will further investigate whether during an~     acute episode of HA elevated brain Gln and decreased mI levels correlate with the magnitude~     of cytotoxic edema and whether a Gln/mI ratio threshold can be identified at which the~     cytotoxic edema is followed by cell loss. Finally, the researchers will investigate whether~     regions of brain damage in ASSD and/or ASLD are distinct from those in OTCD and compare brain~     Gln levels in ASSD and ASLD in the absence of HA to those in OTCD. The investigators will~     also seek to determine if brain citrulline and ASA can be identified in the brains of~     patients with distal UCD and whether they correlate with brain abnormalities seen in MRI and~     neuropsychological testing. This project will elucidate the chronology of brain pathology~     both in acute hyperammonemia and chronic UCD and whether, proximal and distal UCD differ in~     their pathophysiology of brain damage.~   "
48257|NCT02935270|"~     The purpose of this study is to examine measurement of unilateral neglect post stroke.~     Although a number of clinical assessments are used to measure neglect, it is unclear whether~     items from some of the most commonly used assessments are able to effectively and~     comprehensively measure neglect. This study will determine whether these assessments measure~     different aspects of neglect and whether items from various neglect assessments can be~     combined to more effectively measure neglect.~   "
48258|NCT02935257|"~     This is a multi-centre, non-randomised, open label Phase I clinical trial of an Advanced~     Therapy Investigational Medicinal Product (ATIMP) in adults (age 16 to 65 years) with high~     risk, relapsed/refractory CD19+ B-ALL. The ATIMP for this study is cryopreserved autologous~     patient-derived T-cells transduced with a lentiviral vector to generate the CD19CAT-41BBZ CAR~     T-cells (referred to subsequently as CD19CAR T-cells). Patients will undergo an unstimulated~     leucapheresis for the generation of the ATIMP which will take approximately 15 days to~     generate. During this period, patients may receive holding chemotherapy as per~     institutional practice to maintain disease control. Patients will receive pre-conditioning~     lymphodepleting chemotherapy with cyclophosphamide 60mg/kg on Day -6 and fludarabine 30mg/m2~     administered over 3 days (Day -5 to Day -3).~      The study is designed as an intra-patient dose escalation employing a total dose range (over~     2 doses, Dose 1 and Dose 2) of between 5 x 106 CD19CAR T-cells and 1.1 x 109 CD19CAR T-cells.~     The study will evaluate ATIMP safety and efficacy and the duration of disease response in~     adults with high risk / relapsed CD19+ B-ALL.~      After completing the interventional phase of the study all patients, irrespective of whether~     they progressed or responded to treatment, will enter long term follow up until 5 years~     post-CD19CAR T-cell infusion.~   "
48259|NCT02935244|"~     ASPIRE-SSI is a prospective, observational, multicentre cohort study among adult surgical~     patients, which aims to determine the incidence of healthcare-associated S. aureus~     infections, particularly S. aureus surgical site infections (SSIs), across Europe and to~     assess the most important risk factors for this type of infection.~   "
48260|NCT02935231|"~     Background: Many smokers cannot quit due to nicotine withdrawal symptoms, which peak at the~     first week of abstinence. Proactive recruitment of smokers is needed as most smokers do not~     seek smoking cessation (SC) services. A smoking hotspot (SH) is defined as a public outdoor~     place where smokers stop/linger and smoke. We aim to include a reasonably representative or~     unbiased sample of SH at different locations from all 3 regions of Hong Kong. We will~     randomly select 6 eligible SH (2 in each regions) from the 15 hotspots in our previous~     community trial.~      Methods: Two trained SC ambassadors (student helpers) and one supervisor (experienced~     research assistant) will be deployed for each session of intervention at a SH. Potential~     subjects will be approached using the a-foot-into-the-door method in which SC ambassador~     will ask if smoker would like to reduce/quit smoking and receive SC intervention or advices.~     Smokers will be assessed for eligibility and informed written consent will be sought.~     Subjects will complete a brief self-administered questionnaire (baseline) using tablet. To~     reduce later hang-ups of telephone interventions or surveys, SC ambassador will save contact~     number of the trial into subjects' mobile phones.~      Discussion: The findings will provide much needed and original evidence to support a main RCT~     on these new, proactive, simple and low-cost interventions for improving current SC services~     and policy for smokers who do not actively seek help from SC services in Hong Kong and~     elsewhere.~   "
48261|NCT02935218|"~     N=15 mothers with Borderline Personality Disorder who had young children (aged 0-6 years)~     participated in a 12-week training program. To estimate the participants' impairment,~     parental stress and psychological distress were assessed before the training. After the~     training, participants and trainers were asked to provide feedback regarding the valuation of~     and the changes due to the training.~   "
48262|NCT02935205|"~     This phase I/II trial studies the side effects of enzalutamide and indomethacin and to see~     how well they work in treating patients with prostate cancer that does not respond to~     treatment with hormones, has come back, or has spread from where it started to other places~     in the body. Androgens can cause the growth of prostate cancer cells. Hormone therapy using~     enzalutamide and indomethacin may fight prostate cancer by lowering the amount of androgen~     the body makes and/or blocking the use of androgen by the tumor cells.~   "
48263|NCT02935192|"~     A Phase 3, double-blind, randomized, placebo-controlled trial of a seasonal, trivalent,~     split, inactivated influenza vaccine produced by Torlak.~   "
48264|NCT02935179|"~     The purpose of this project is to use white-skinned sweet potato as the main material for~     weight control for overweight and obesity, the non-communicable diseases (cardiovascular~     diseases, cancers, chronic respiratory diseases and diabetes) are also included. All high~     quality sweet potato are provided by CAES in Taiwan to produce special nutrient food and~     health food that to do functional study in Shih Chien University and Taipei Medical~     University. In this study, the investigators will recruit overweight and obesity subjects~     that divide into white sweet potato group (experimental group) and no intervention group~     (control group) by using randomized, parallel and open clinical study in sixty days.~   "
48265|NCT02935166|"~     Respiratory muscle weakness and fatigue are related to clinical deterioration in patients~     with Chronic Obstructive Pulmonary Disease (COPD). Respiratory muscle training (RMT) is a key~     therapeutic strategy in these patients. It is necessary therefore to increase its~     dissemination on a large scale, improve patient´s adherence and optimize the control of the~     implementation of training. The aim of this project was to design a RMT device including~     light and sound incentives, digital registration application and analysis of the training~     sessions, and studying the effectiveness of a new shortened RMT scheme of high intensity that~     could provide added value to enhance the implementation of training in patients with COPD.~     From an operational point of view, researches were organized into three packages of~     complementary work focused on the design of a new portable dual valve with electronic~     lighting and auditory incentives components. The conceptualization and design of a software~     to analyze the performance and individual continuous use of the valve, and the evaluation of~     the feasibility, safety and efficacy of a shortened schedule of respiratory muscle training~     in adult patients with COPD were realized.~   "
48266|NCT02935153|"~     The overall purpose of this study is to explore the therapeutic effect of CD22-targeted~     chimeric antigen receptor T(CAR-T) cells in the treatment of Malignant B-cell Derived~     Leukemia and Lymphoma.~   "
48267|NCT02935140|"~     Many children who are born medically fragile due to prematurity, multiple congenital~     abnormalities or an acquired insult (i.e. cardiac, neurologic, etc.) may require tracheostomy~     tube placement due to need of chronic respiratory support. Patients on tracheostomy tubes are~     often unable to vocalize, causing a delay in speech development and poor speech. To help~     restore normal phonation and promote language development in young pediatric patients with~     tracheostomies, speaking valves are used. Previously it was shown that the Passy-Muir~     speaking valve was safe to use during sleep in children by showing there were no adverse~     cardiopulmonary events seen. One objective measurement that was not evaluated was~     trans-tracheal pressure manometry. The purpose of this study is to continue to validate the~     safety of the Passy-Muir speaking valve while asleep, with the use of trans-tracheal~     manometry by comparing expiratory pressure manometry while the patient is awake and asleep.~   "
48268|NCT02935127|"~     Absorbable sutures are not generally accepted by the majority of vascular surgeons for the~     possible complications such as the breakage of the suture at the anastomoses level. Some~     experimental and clinical studies in the current literature demonstrated that the use of~     absorbable sutures may even reduce some important complications such as restenosis.~      The aim of this study is to compare absorbable and non-absorbable sutures in patients~     undergoing peripheral vascular surgery with vein bypass grafting.~   "
48269|NCT02935114|"~     Objectives: This study will determine the clinical efficacy of bleaching agent 37% carbamide~     peroxide compared to 35% hydrogen peroxide on the change of color scores in anterior superior~     teeth, in-office bleaching technique after 7, 14 and 37 days; and the Risk to the tooth~     sensitivity before, during and 24 hours after the procedure.~      Materials and Methods: Fifty patients will be selected for this single-blind, parallel,~     randomized-controlled clinical trial. The whitening treatment with 37% carbamide peroxide or~     35% hydrogen peroxide (control) will be carried out in a single application of 45 minutes for~     two sessions with a 7-day interval. The sensitivity level will be assessed before, during and~     24 hours after the procedure using verbal and analogic visual analogue (VAS) scales. Color~     alteration will be assessed by a bleach guide scale 7 days after each session and 30 days~     after the last session. Relative risk to sensitivity will be calculated and adjusted by~     session; while comparison of overall risk will performed by McNemar's test. Data on the~     sensitivity level for both scales will be subjected to the Mann-Whitney tests (α = 0.05). The~     color change will be measured with a spectrophotometer using the CIE L * a * b * and the L*,~     a * and b * parameter delta data, and ΔE and Δ00, will be individually subjected to two-way~     repeated measures ANOVA test to compare the two bleaching techniques at each evaluation time~     (α = 0.05).~   "
48270|NCT02935101|"~     The purpose of this study is to evaluate whether prednisolone lowers intensity and frequency~     of craving in heroin-addicted subjects undertaking a detoxification of cocaine and/or heroin.~   "
48271|NCT02935088|"~     The purpose of this study is to understand routine use of FFR (Fractional Flow Reserve) and~     alternate indices in clinical practice. This study will determine the use and clinical~     outcome of FFR-guided PCI in patients presenting with either stable coronary artery disease,~     or in patients presenting with Acute Coronary Syndrome (ACS) on culprit and non-culprit~     lesions as well as during index and secondary procedures.~   "
48272|NCT02935075|"~     The combination antiretroviral therapy (cART) inhibit HIV replication effectively. However,~     synergy among these drugs has not been well considered. The dose of drugs used as monotherapy~     is the same as that used in combination therapy. Tenofovir+lamivudine+efavirenz is still the~     first line regimen of cART in developing countries. The side effects of these drugs are~     related to the concentration of drugs. Based on our previous data, we aim to evaluate whether~     reduce the dose of tenofovir and efavirenz could decreasing the incidence of the side effects~     while not scarifying their virological efficacy.~   "
48273|NCT02935062|"~     The aim of this study is to compare phonological and auditory aspects of children submitted~     to traditional phonological therapy, phonological therapy using a software and placebo~     therapy in children with phonological disorders.~   "
48274|NCT02935049|"~     For tough colic resection, evaluation of our practice for these lesions unresectable in~     monoblock and evaluation of the contribution of the hybrid technique EMR (mucosectomy~     dissection) /ESD (submucosal dissection)~   "
48275|NCT02935036|"~     Safety and efficacy study in patients with acne vulgaris~   "
48276|NCT02935023|"~     The goal of this clinical study is to determine impact of carbon ion radiotherapy (CIRT)~     treatment in combination with systemic therapy for oligo-metastatic prostate cancer. The~     primary objective: to determine disease biochemical progression-free survival in man with~     oligo-metastatic (M1a/b) prostate cancer undergoing systemic therapy with definitive~     radiotherapy of the primary tumor. The secondary objective: to determine local control,~     overall survival and quality of life in men with oligo-metastatic prostate cancer undergoing~     carbon ion radiotherapy~   "
48277|NCT02935010|"~     With markedly increased antibiotic resistance and unsatisfactory efficacies of common empiric~     eradication regimens in the mainland of China, tailored therapy may be the best choice to~     achieve good efficacy. This study compared the eradication rates, safety, and compliance of~     antibiotic sensitivity-based tailored therapy compared with empiric bismuth quadruple therapy~     in the naive patients with Helicobacter pylori infection.~   "
48278|NCT02934997|"~     To determine the role of dysfunctional high density lipoprotein (Dys-HDL) in predicting or~     mediating progression to chronic critical illness or morbid long-term outcomes in patients~     being treated for community-acquired or hospital-acquired sepsis.~   "
48279|NCT02934984|"~     The aim of the study is to evaluate whether peripheral circulating cell-free tumor DNA(ctDNA)~     can help early screening of pancreatic cancer recurrence or not. And we are also planning to~     evaluate correlation between ctDNA with clinical outcome of pancreatic cancer.~   "
48280|NCT02934971|"~     The present project will develop an automated machine learning approach using multi-modality~     data (imaging, laboratory, electrocardiography and questionnaire) to increase the~     understanding and prediction of arising heart failure in patients scheduled for cardio-toxic~     chemotherapy. This algorithmus will be developed by the technical cooperation partner at~     Technion, the institut for biomedical engineering in Haifa, Israel.~   "
48281|NCT02934958|"~     We plan to study whether the impact of offering the choice of a pre-colonoscopy physician~     visit or direct referral to colonoscopy will increase adherence to colonoscopy relative to~     usual care in a large fecal immunochemical test (FIT) mailing campaign.~      We will evaluate two study options, usual care during which patients will be required to have~     an office visit with wither a PCP or a Gastroenterologist prior to being scheduled for a~     colonoscopy, or a choice where patients will be given the option of a pre-colonoscopy visit~     with a gastroenterologist or PCP vs. direct referral for a colonoscopy.~      In these two options we will examine colonoscopy adherence, adequacy of triage, patient~     satisfaction, colonoscopy outcomes (no show rate, prep quality, and pain during colonoscopy)~     and how insurance coverage, gender, race, education or patient understanding of colon cancer~     screening message during the navigation process might impact outcomes.~   "
48282|NCT02934945|"~     Bronchial asthma is a common respiratory disease characterized by chronic airway~     inflammation, which have been affecting about 1-18% of the population in the world, causing~     tremendous economic burden for the patients and countries. Generally, asthma is a~     heterogeneous disease, and it could be classified into many types on the basis of symptoms,~     that is, typical asthma, cough variant asthma, and chest tightness variant asthma etc.~     Typical asthma (TA) is defined according to the history of repeated respiratory symptoms such~     as wheeze, shortness of breath, chest tightness, and cough, usually with reversible airflow~     limitation, airway hyper-responsiveness, and airway remodeling. Cough variant asthma (CVA) is~     characterized by the single manifestation, recurrent cough, which could be improved after the~     use of bronchodilators. However, according to different guidelines, it is still controversial~     on the treatment of CVA and TA. The guidelines of Global Initiative for Asthma(GINA) in 2014~     put forward the treatment of TA patients, but did not list the treatment specific to CVA. The~     guideline of ACCP（American College of Chest Physicians） and cough guidelines of China are~     proposed to treat the CVA effectively with bronchial diastolic drug. Inhaled corticosteroids~     (ICS) and leukotriene receptor antagonists are effective for the treatment of CVA. Currently,~     more and more studies supported that application of ICS combined with bronchial dilation~     agents is more beneficial to CVA patients. Budesonide/formoterol is a compound of ICS and~     long-acting beta2-agonist(LABA), which can not only be used as a maintenance medication, but~     also be used as a relief medication, namely, budesonide/formoterol treatment regimen for~     SMART (Symbicort as both maintenance and reliever therapy). Most studies show that SMART~     treatment can be used in the treatment of TA patients. But the study on whether~     budesonide/formoterol can be used to treat CVA is still little. To provide basis for clinical~     medication guidance for patients with CVA and TA, this study will enroll 30 patients with TA~     or CVA , who will be required to adopt the SMART regimen in the following 6 months.The~     symptom score, airway inflammation, pulmonary function and airway reactivity changes, will be~     measured every mouth. After the study finished, the investigators will compare the difference~     between the two groups.~   "
48283|NCT02934932|"~     Determine if brexpiprazole treatment will be associated with a dose-dependent reduction in~     resting pupil diameter as a reflection of locus coeruleus (LC) norepinephrine (NE) neuron~     target engagement in a group of subjects with PTSD. All subjects will be evaluated by~     physical examination, ECG, standard blood chemistry, hematologic labs, toxicology testing,~     and urinalysis. Results of these studies must demonstrate a lack of clinically significant~     abnormalities prior to enrollment. Subjects will need to satisfy DSM-5 criteria for PTSD and~     receive a CAPS-5 score of 40 or greater on testing for study enrollment. Resting pupil~     diameter during pupillometric evaluation after two weeks on each treatment will serve as the~     primary outcome measure. This will be compared in the treatment groups using mixed effects~     repeated measures models to evaluate if there is a significant difference in pupil size among~     the treatments studied. As a secondary analysis this approach will be used to evaluate~     whether there is treatment effect on total CAPS-5 score. Lastly, the investigators will~     compute correlations between pupil size and CAPS-5 scores.~   "
48284|NCT02934919|"~     Impulse control disorders (ICDs) (such as pathological gambling, hypersexuality, compulsive~     shopping …) are an increasingly recognized psychiatric complications in Parkinson's disease~     (PD). Therapeutic management of these disorders is important since they have an impact on~     patient quality of life. Dopamine agonists play a key role in the emergence of ICD.~      Animal models and imaging underline the implication of opioid system in the genesis of ICD.~      An opioid antagonist, the naltrexone, has been studied to treat ICDs in PD. Papay and al 2014~     have found that patients treated by naltrexone showed an interesting decrease of their ICDs~     measured by the QUIP RScale. Nevertheless, naltrexone has shown adverse effects such as~     increasing hepatic liver enzymes. Nalmefene has no known hepatic adverse effects. Nalmefene~     is an opioid antagonist that has an antagonist action on μ and δ receptors, but also an~     agonist action on κ receptor. Grant and al 2006 has shown significant reduction of the~     severity of pathological gambling in patients treated with nalmefene.~      The primary purpose is to evaluate the efficacy and the safety of nalmefene in the treatment~     of ICDs in PD.~   "
48285|NCT02934906|"~     This clinical study aims to investigate the anti-HPA antibodies caused neonatal alloimmune~     thrombocytopenia in Chinese pregnant women. The survey and data collect will help form an~     appropriate clinical screening procedure~   "
48286|NCT02934893|"~     The benefit of drug therapy to persons with diabetes has been well established in clinical~     trials in terms of reducing cardiovascular risk, microvascular complications and mortality.~     However, treatment adherence and treatment effectiveness continue to be challenges in~     diabetes management.~      Rimidi Diabetes has developed software algorithms to simulate the effect of anti-diabetic~     medications on an individual's glucose profile, allowing the clinician and their patient to~     visualize the anticipated outcome of a medical intervention. Use of this technology should~     allow for more targeted decision-making by the clinician and should facilitate a shared~     decision-making process with the PwD who is now privy to the thought process behind their~     medical management.~      The proposed study is designed to test whether adding a decision support capability~     (Diabetes+Me Rx) that allows for modeling the anticipated effect of medication adjustments~     leads to improved glycemic control and a perceived benefit by healthcare providers and PwDs.~   "
48287|NCT02934880|"~     Breast cancer is the most frequent cancer in women in western countries. The improvement of~     therapeutic management associated to the developement of supportive care allows patient to~     live longer in better conditions. But several studies have showed the deleterious impact of~     treatment such as chemotherapy on cognition. To limit these damages, non therapeutic~     approaches such as Adapted Physical Activity (APA) have been developped.~      The goal of this study is to evaluate the benefit of APA program on cognitive functions in~     patients with locally advanced breast cancer.~   "
48288|NCT02934867|"~     Medical call center have no phone advice protocol within out of hospital cardiac arrest in~     France. The purpose of the present study is to compare a group of patients with protocol~     phone advice delivered by the dispatchers (CONTARM group) versus usual phone advice (~     CONTHAB group). Comparison will be performed on survival to seven days. The hypothesis is~     that CONTARM group has an higher survival at seven days. A second goal is to measure the~     survival to 15 and 30 days. The trial is randomized, controlled and will include 2600~     patients. The patients will be enrolled in 19 hospitals in France.~   "
48289|NCT02934854|"~     Development of a new MS-based biomarker for the early and sensitive diagnosis of creatine~     deficiency syndromes from plasma~   "
48290|NCT02934841|"~     The investigators hypothesize that it is safe and effective to treat patients with choroidal~     neovascularisation (abnormal blood vessels growing under the retina) secondary to uveitis~     with Conbercept.~      This will be a randomized, placebo-controlled trial. 20 patients will receive three~     injections of Conbercept into the affected eye (and repeated injections if required), and 20~     patients will receive three sham injections requiring no needle stick, but making the patient~     unaware of whether or not he received active treatment.~      Outcome of the two treatment groups will be compared after one year.~   "
48291|NCT02934828|"~     The investigators research aim to explores the optimal comprehensive treatment for TNBC and~     her2 positive breast cancer by comparing the efficacy of neoadjuvant with that of adjuvant~     treatment in improvement of RFS.~   "
48292|NCT02934815|"~     To test the feasibility of supportive-expressive group intervention (SEGT) for women with~     primary breast cancer and to provide a preliminary test of its efficacy.~   "
48293|NCT02934802|"~     This post-market clinical follow-up study intends to investigate the survival rate at 5 years~     of the e.motion® PS Pro System.~   "
48294|NCT02934789|"~     This study aims to evaluate the quality of life in patients treated for submucosal leiomyomas~     using the Truclear hysteroscopic morcellator compared to women managed medically. Study~     population includes women age 18 and older with symptomatic submucosal myomas. Patients will~     be asked to complete the Uterine Myoma Symptom and Health-related Quality of Life~     Questionnaire (UFS-QOL) at enrollment and at 1, 3, and 6 months after treatment.~   "
48295|NCT02934776|"~     The purpose of this study is to examine if investigators can improve diagnosis of prostate~     cancer by using MRI/DTI?~   "
48296|NCT02934763|"~     Opioid Induced Hyperalgesia (OIH) is an entity than has been demonstrated in healthy~     volunteers and in animal models. Is defined as an increase in the perception to painful~     stimuli, increasing the opioid requirements and diminishing the pain thresholds to stimuli.~      The apparition of OIH is also related to the exposure to opioids during surgery, depending of~     the dose, the time of exposition and the type of opioid.~      This condition can be modulated, specially in the perioperative context. It has been seen in~     healthy volunteers and in animal models, than the use of propranolol can modulate this~     phenomena, diminishing the postoperative requirements of analgesia. It is also unknown, the~     dose of propranolol required to modulate adequately OIH.~      The objective of this work is to evaluate the efficacy of propranolol in the modulation of~     opioid induced hyperalgesia, with lower postoperative requirements of analgesia rescue.~   "
48297|NCT02934750|"~     This randomized, cross-over study aims at describing the effect of pursed lip breathing on~     exercise-induced dyspnea and exercise capacity in patients with interstitial lung disease.~   "
48298|NCT02934737|"~     Obese patients will be enrolled from 2006 to 2014. The progression of diabetes mellitus will~     be observed (if any). Anthropometric and biochemical parameters will be evaluated.~   "
48299|NCT02934724|"~     The overall aim of the study is to assess the effect of school-based Human Papillomavirus~     (HPV) vaccination by comparing type-specific HPV prevalence between vaccinated and~     non-vaccinated women born in 1997. Women born in 1997, residence to Norway in 2009 (the year~     of vaccine initiation of the 1997-cohort) are invited to participate in the study.~   "
48300|NCT02934711|"~     Identify and analyze in the exercise groups coordinated (GECO) the effects of coordination~     arrangements between professionals on the transformation of modes of exercise of professional~     care, and on the experience of patients / users and that of caregivers, particularly on~     dimensions constituted that the quality of care in order to build a coordinated exercise~     structures rating scale primary care on the basis of criteria suggested by patients~   "
48301|NCT02934698|"~     This postmarketing N of 2 study is designed to evaluate the efficacy and safety of open-label~     ivacaftor treatment in two sisters with cystic fibrosis and pancreatic sufficiency.~   "
48328|NCT02934347|"~     Our hypothesis is that the view of the glottis may be improved by putting all patients~     requiring intubation in the ramped or back up position while maintaining the classic sniffing~     position.~   "
48302|NCT02934685|"~     To determine if hypofractionated IG-VMAT (70 Gy in 28 fractions over 5.6 weeks) will result~     in disease-free survival (DFS) that is no worse than DFS following conventionally~     fractionated IG-VMAT (80Gy in 40 fractions over 8 weeks) in patients treated for localized~     prostate cancer. Analysis the local progression, disease-specific survival (DFS), freedom~     from biochemical recurrence (FFBR), and overall survival (OS) of two groups. Observe the~     incidence of GI and GU toxicity.~   "
48303|NCT02934672|"~     The primary objectives of the survey are to obtain patient preference information that can be~     useful during the benefit-risk assessment of the KineSpring System.~   "
48304|NCT02934659|"~     The primary objective of this pilot study is to collect data on the safety and effectiveness~     of the Atlas Knee System in subjects with medial knee osteoarthritis through 24 months~     postoperative follow-up.~   "
48305|NCT02934646|"~     This is a phase-II clinical study to assess whether intense passive mobilization of the elbow~     during the early stage is effective in preventing spasticity from occurring at a later stage.~     A group of subacute stroke patients was treated with the device named NEUROExos Elbow Module~     (NEEM) on a daily basis, in addition to traditional physical therapy. The outcome was~     assessed in terms of (i) system safety, (ii) system usability and (iii) treatment efficacy.~      Investigators expected that intense therapy performed in the sub-acute phase following the~     stroke would be effective in preventing elbow spasticity from occurring at a later stage~     (i.e. 3-4 months after the stroke), the latter being quantified by means of the Modified~     Ashworth Scale (MAS). Similarly to other phase-II studies in the field of post-stroke~     rehabilitation, the present study will include only one group of patients. As a secondary~     objective, similarly to other studies with robot-assisted therapy, investigators wiil test~     the ability of this system to be used for assessing rehabilitation outcome. Investigators~     will introduce novel evaluation metrics based on the kinematics and kinetics variables~     recorded by the NEEM and compared them with MAS values.~   "
48306|NCT02934633|"~     This project completed an intervention designed to teach parents of children aged 0-2 years~     of age how to prevent injuries to their child. The intervention consisted of a two DVD~     package with information on creating a safe home environment and correctly choosing and~     installing an appropriate car safety seat. The study hypothesis was that parents who used the~     intervention would score significantly higher on measures of knowledge, motivation, intention~     and self-efficacy in implementing injury prevention strategies.~   "
48307|NCT02934620|"~     Globally, women in established relationships remain at risk for unintended pregnancy and~     sexually transmitted infections (STIs), including HIV. In Vietnam, the location of the~     proposed research, unmet need for contraception is substantial as reflected in the nation's~     high abortion ratio. Married women account for about one-third of HIV cases in Vietnam, and~     among this group, most were exposed to the virus through sexual activity with their husband.~     Condoms will remain crucial for prevention for some time to come. Sustained condom use,~     however, is notoriously difficult to achieve. A key barrier to the consistent use of condoms~     is their effect on sexual pleasure. Although sexual pleasure is a primary motivation for~     engaging in sex and is an integral part of overall sexual health, most programs to improve~     sexual health operate within a pregnancy and disease-prevention paradigm. A new condom,~     CSD500, containing an erectogenic drug was developed for use among healthy couples to improve~     sexual pleasure by increasing penile firmness, size and erection duration. The overall~     objective of the proposed two-arm randomized trial is to test whether promoting the novel~     condom CSD500 for improved sexual pleasure results in couples having less unprotected vaginal~     sex. Investigators will measure the occurrence of unprotected vaginal sex by testing women's~     vaginal fluid for the presence of prostate-specific antigen (PSA), an objective, biological~     marker of recent semen exposure. Investigators will randomize 500 adult, heterosexual,~     monogamous couples in Thanh Hoa province, Vietnam to receive either CSD500 for sexual~     pleasure or the standard condom currently provided only for pregnancy and disease prevention~     to patients during routine care. Study staff will interview female participants at enrollment~     and after 2, 4, and 6 months and their male partners at the 6-month visit. Study clinicians~     will sample vaginal fluid from female participants at all visits to test for the presence of~     PSA.~   "
48308|NCT02934607|"~     This study will be conducted to establish the relative bioavailability of budesonide and~     formoterol delivered via Symbicort pressurized metered-dose inhaler (pMDI) with and without a~     spacer device.~      Administration under each condition will occur with the concomitant administration of~     activated charcoal to estimate exposure through the lung and without activated charcoal to~     estimate total systemic exposure.~   "
48309|NCT02934594|"~     Patients with metastatic spinal cord compression (MSCC) are treated with different options~     according to the life expectancy. Survival and surgical outcome can be influenced by surgical~     timing in MSCC patients treated with palliative decompression.~   "
48310|NCT02934581|"~     A prospective observation study to screen adult obese (BMI ≥30 kg/m2) patients who were newly~     admitted to the medical intensive care units and turned out to be diagnosed as Obesity~     hypoventilation syndrome(OHS). The investigators purpose is to look into the prevalence,~     predictive factors, and outcomes of OHS in these critically ill patients.~   "
48311|NCT02934568|"~     This study is to allow continued use of ribociclib (LEE011) as single agent or in combination~     with other investigational treatments in patients benefitting from treatment in an eligible~     Novartis-sponsored ribociclib (LEE011) study that has reached its primary objective(s) or has~     been halted for other reasons.~   "
48312|NCT02934555|"~     To study the effects of ubiquinol as a metabolic resuscitator in post-cardiac arrest.~   "
48313|NCT02934542|"~     The objective of this study is to evaluate the ability to reduce the number of OR personnel~     required while performing the following procedures: colon resections, cholecystectomies and~     anti-reflux/hiatal hernia surgery with the AutoLap system compared with the standard~     operation.~   "
48314|NCT02934529|"~     The FIRE-4 study aims to define a treatment concept for patients with RAS wild-type tumours,~     optimised with regard to overall survival. The first-line treatment will be conducted with~     FOLFIRI plus cetuximab, which resulted in a significantly prolonged overall survival versus~     bevacizumab in the FIRE-3 study. Following initial progression (PD1) it is recommended that~     the treatment be continued with FOLFOX plus bevacizumab, as this concept led to significantly~     prolonged survival in the E3200 study. Owing to the encouraging results of the Santini study~     , a cetuximab rechallenge in combination with irinotecan-based chemotherapy is to be~     performed as part of the third-line treatment in patients who showed a response defined~     according to RECIST 1.1 during the first-line treatment (tumour diameter < -30%) or presented~     with stable tumour disease for at least 6 months (tumour diameter +20 to -30%). The concept~     of the ideal sequence has not yet been studied to date in a clinical trial.~   "
48315|NCT02934516|"~     The study aims to compare maternal and early neonatal outcomes of abdominal disimpaction with~     lower uterine segment support in comparison to the classic push method for delivery of~     impacted fetal head during Cesarean section for obstructed labor.~   "
48317|NCT02934490|"~     The study is to explore the effectiveness of a new-style anterior vaginal wall mesh in the~     treatment of female stress urinary incontinence(SUI). Meshes were made by Gynemech TM PS,~     (Johnson & Johnson Shanghai Medical Equipment Co. China Food and Drug Administration (CFDA)~     registration No. 3460365, size 10 × 15cm). Meshes were cut to appropriate size. The~     incontinence questionnaire summary table (ICIQ-SF), pad test, urodynamic and other diagnostic~     tests were used for preoperative assessment and the evaluation of postoperative surgical~     outcome and complication. The results were compared with the one-year cure rates of Burch and~     trans vaginal taping (TVT) surgeries. The analysis indicated that the surgery using the~     new-style anterior vaginal mesh, as a minimally invasive procedure, not only achieved its~     expectation with similar cure rate to Burch, TVT/ trans vaginal taping obturator (TVT-O)~     surgeries, but also has lower economic cost and complication rate than the TVT /TVT-O~     approach. The evaluation of long-term treatment effect needs further follow-up of the~     patients.~   "
48318|NCT02934477|"~     This observational study will compare outcomes of a prospectively-enrolled cohort of~     Hematopoietic Stem Cell Transplant (HCT) recipients with outcomes of a cohort of age-matched~     historical non-HCT controls. Patients undergoing alloHCT will receive HCT in a US transplant~     center and be reported to the Center for International Blood and Marrow Transplant Research~     (CIBMTR) using well-established CIBMTR report forms and data collection procedures as well as~     a study-specific supplemental form. Data on the historical non-HCT controls will be collected~     at 14 US academic centers. These centers will provide data on all consecutive patients with~     PMF, post-ET MF, or post-PV MF referred to their institutions between 2000 and 2012.~   "
48319|NCT02934464|"~     This is a randomized, open-label, multicenter phase III trial of ramucirumab plus paclitaxel,~     given as switch maintenance, versus continuation of first-line chemotherapy, given as per~     standard clinical practice, in subjects with unresectable locally advanced or metastatic~     HER-2 negative gastric or GEJ cancer, without disease progression following 3 months of~     first-line doublet chemotherapy.~      The acceptable first-line or lead-in chemotherapy will be:~        -  FOLFOX4:Oxaliplatin 85 mg/m2. l-Leucovorin 100 mg/m2 5-fluorouracil 400/600 mg/m2. Cycle~          length is 2 weeks +/- 3 days.~        -  ModifiedFOLFOX6: Oxaliplatin a 85 mg/m2. l-Leucovorin 200 mg/m2. 5-fluorouracil 400~          mg/m2 and 2400 mg/m2 46-hours continous infusion. Cycle length is 2 weeks +/- 3 days.~        -  XELOX:Oxaliplatin130 mg/m2.Capecitabine will be 2000 mg/m2 for 14 days. Cycle length is~          3 weeks +/- 3 days.~   "
48320|NCT02934451|"~     Osteogenesis imperfecta (OI) is a rare inherited disorder that causes bones to break easily.~     Individuals with osteogenesis imperfecta break bones often and may have other problems,~     including hearing loss and pain and difficulty getting around. People with moderate to severe~     OI may also be diagnosed with dentinogenesis imperfecta (DI). DI is characterized by grey or~     brown teeth that may chip and wear down and break easily. People with DI may also have skull~     and neck defects. These patients may have severe teeth misalignment resulting in clinically~     significant chewing problems. Teeth misalignment in OI is very hard to treat because of the~     quality and quantity of bone. The overall goal of this study is to improve dental health to~     improve the quality of life of people with OI.~   "
48321|NCT02934438|"~     Reduced nitric oxide (NO) availability is a hallmark of a number of cardiovascular diseases~     (CVD) including peripheral artery disease (PAD). The investigators will test the hypothesis~     that sub-chronic NEO40™ supplementation will improve vascular NO function and improve~     intermittent claudication in patients with PAD. Using a prospective, double blind, placebo~     controlled experimental design in 30 patients, graded treadmill tests will be performed at~     baseline and after 3 months after randomization, according to the Skinner-Gardner protocol.~     Initial claudication distance (ICD) and absolute claudication distance (ACD) will be~     recorded. Two consecutive treadmill tests will be performed within 1 week at baseline (before~     administration of study drug); and 2 test will be performed at 3 months. Functional status~     will also be assessed by the Walking Impairment Questionnaire and the Health Status Survey~     SF-36 questionnaire (SF-36). Vascular function will be assessed with the use of a Vendys®~     vascular reactivity (endothelial function) test (Endothelix Inc). Digital pulse amplitude~     will be assessed using sensor probes on the index finger during reactive hyperemia. Blood~     will be collected for measurement (by Neogenis) of plasma levels of nitrite and nitrate at~     baseline and at the completion of the study. Based on previously published trials using this~     NO technology, the investigators predict that the group receiving the active supplement will~     exhibit an improvement in claudication distance and all measures of vascular function after 3~     months.~   "
48322|NCT02934425|"~     The goal of this study is to assess the effects of consumption of a lean pork-containing,~     high-protein breakfast versus a refined carbohydrate-rich breakfast on satiety and~     cardiometabolic parameters in overweight or obese adults with pre-diabetes.~   "
48323|NCT02934412|"~     This is a randomized, double-blind, placebo-controlled, single dose escalating, study in 5~     sequential cohorts to investigate the effect of a single s.c. injection of SHR-1314 at 5 dose~     levels (20mg, 40mg, 80mg, 160mg, and 240mg) in healthy subjects. Each cohort will consist of~     6 subjects receiving active drug and 2 subjects receiving placebo, for a total of~     approximately 40 subjects dosed at one study site.~   "
48324|NCT02934399|"~     The study will investigate 27 hour profiles of hormones in the subcutaneous tissue of healthy~     subjects and patients with Addison's, Congenital Adrenal Hyperplasia, Growth Hormone~     Deficiency, acromegaly, Cushings and Primary Hyperaldosteronism during conventional~     diagnostic and therapeutic follow-up.~      The 27 hour monitoring by ULTRADIAN takes into account the rhythm of hormones throughout the~     day. It is hoped that this information may in the future improve and simplify diagnostic~     procedures. Follow-up of patients in endocrinology still remains difficult including clinical~     signs of over and under-treatment, questionnaires of quality of life and blood testing~     necessitating often retesting. Simplification of the diagnostic procedure by obtaining~     detailed knowledge about the rhythm of hormones may contribute to the improvement and~     individualization of treatment and may decrease morbidity and mortality of endocrine~     patients.~   "
48325|NCT02934386|"~     The study will evaluate the accuracy of BP measurements by a new algorithm to be embedded to~     the existing CE-marked WinPack device, compared to two reference devices (one oscillometric~     and one volume-clamp device), in healthy subjects and patients undergoing a standardized~     physical-activity hypertensive protocol.~   "
48326|NCT02934373|"~     Clinical study designed to collect user feedback from Cochlear Implant recipients on a new~     Sound Processor System~   "
48329|NCT02934334|"~     The Wellness Monitoring for Major Depressive Disorder (MDD) study is a prospective,~     longitudinal, observational study aimed at identifying biomarkers of relapse in MDD. Results~     may help refine clinical approach to relapse management, and may ultimately help MDD patients~     sustain wellness while on antidepressant medication.~   "
48330|NCT02934321|"~     Erythritol is a low calorie sugar substitute that is being increasingly used to sweeten~     beverages and other food items. Greater amounts of erythritol are required to reach the~     sweetness level of a common soft drink as compared to aspartame, resulting in higher~     osmolarity for the erythritol sweetened beverage. Since associations have been noted between~     osmolarity and satiety, investigators propose that an erythritol sweetened beverage may~     enhance satiety more than a beverage sweetened with aspartame.~   "
48331|NCT02934308|"~     Pain in hospitalized patients has received increasing attention, however due to its~     subjective nature, it has defied objective, quantitative measurements. If a patient is able~     to communicate, pain may be assessed using standardized sentences, visual analog scales (VAS)~     or plain numeric scales.When a patient is unable to communicate, a method that would allow~     the caregiver to continuously monitor patients' pain and alert the provider that the patient~     may be in pain would be quite useful. The Pain Monitor uses a novel measurement technique of~     analyzing changes in skin conductance that can be used in patients who are unable to provide~     a subjective pain score. This study will compare the relationship between the measurements~     taken by the PainMonitor and pain scores given by communicative patients to evaluate the~     safety and efficacy of this monitor during planned, routine procedures.~   "
48332|NCT02934295|"~     The aim of the research is to study humoral and cellular immunity in pregnant women for who~     the level of rubella virus antibodies is weakly positive, equivocal or negative with the~     usual laboratory technique.~   "
48333|NCT02934282|"~     The purpose of this protocol is to provide treatment with HBOC-201 to patients with~     life-threatening anemia for whom blood is not an option. Such patients may also be referred~     to in this document as patients who refuse blood transfusion (PWRBT). Other patients who~     potentially may require HBOC-201 treatment include those with red blood cell alloantibodies~     for whom immunologically compatible red blood cell units cannot be found, although these~     patients are less common than PWRBT.~   "
48334|NCT02934269|"~     This is a randomized, double-blind, placebo-controlled study to evaluate the safety,~     tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of CC-90006 following~     administration of single subcutaneous doses in healthy subjects.~   "
48335|NCT02934256|"~     1)Preliminarily evaluate the treatment effect of Icotinib Hydrochloride Tablets on NF2;~     2)Preliminarily evaluate the safety and the patient's tolerance of the treatment of Icotinib;~     3)Provide an objective basis for an enlarged randomized double-blind trial.~   "
48336|NCT02934243|"~     Even if the laryngeal mask (LM) is considered a very safe device with a low incidence of~     complications there may be situations where it is difficult to insert.~      Therefore it seems appropriate to carry out a prospective observational study that will~     identify the risk factors relating to the positioning of LM for the purpose of identification~     and prediction of them.~      From reading the literature and from the opinion of the experts with extensive practice in~     airway management (part of the Working Group Management of Airway of the Italian Society of~     Anaesthesia, Analgesia, Resuscitation and Intensive Care) some possible causes of difficulty~     in the insertion of laryngeal mask have been identified; these possible causes were listed in~     a report that will be distributed to the centers enrolled in the conduction of the study.~      1,864 patients will be enrolled in 8 Italian research centers to calculate the relative risk~     of each of the factors analyzed in order to identify those that, in view of the LM~     positioning, must be modified to reduce the risk of failure and, secondly, to identify the~     risk factors whose presence may contraindicate the use of the device and indicate the use of~     alternative methods for airway management.~   "
48337|NCT02934230|"~     The rapid aging of the population means that anesthesiologists care for elderly patients with~     increasing regularity. Although age is an independent predictor for adverse postoperative~     outcomes, significant outcome variation exists among older surgical patients. Frailty, a~     syndrome that describes an aggregate susceptibility to adverse health outcomes due to age-,~     and disease-related deficits that accumulate across multiple domains is a key predictor of~     adverse postoperative outcomes in elderly patients. Frail surgical patients are at increased~     risk of complications, institutionalization, death, and are high healthcare resource users.~      Multiple stakeholders, including anesthesiologists and patients, have identified improving~     the outcomes of older patients and preoperative exercise training (prehabilitation) as 2 of~     the 10 most important areas for future perioperative research. Physical vulnerability is an~     important aspect of the frailty syndrome, and may be amenable to structured exercise therapy.~     However, the evidence for preoperative exercise training (prehabilitation) improving~     postoperative outcomes is obscured by methodological limitations and a focus on non-elderly~     patients. Recently, evidence has emerged that older and sicker patients may benefit most from~     prehab, however, this hypothesis has not been formally tested.~      Because the complex needs of frail perioperative patients require a longitudinal and~     multidisciplinary approach, the investigators are developing a perioperative surgical home~     for the frail elderly (PSH-Frail). Development of the PSH-Frail is supported by a robust data~     collection system, including linkage of prospectively collected data to health administrative~     data infrastructure to improve efficiency and long-term follow up.~      The investigators hypothesize that prehabilitation will be a vital intervention supported by~     the PSH frail, however, high quality evidence from randomized trials is needed to support its~     efficacy. Therefore, the investigators propose a single center randomized controlled trial of~     prehabilitation of frail elderly patients having elective abdominal and thoracic cancer~     surgery to improve postoperative function (primary outcome), and to decrease postoperative~     resource utilization (secondary outcomes).~   "
48338|NCT02934217|"~     Infarct size is a major determinant of vital prognosis after AMI. We recently reported that~     cyclosporine A, when administered immediately prior to PCI reperfusion, can significantly~     reduce infarct size in STEMI patients. The CIRCUS study aimed at determining the impact of~     cyclosporine on the combined incidence of (death, hospitalization for heart failure, LV~     remodelling) at one year after AMI. However, many patients may display increased adverse LV~     remodelling beyond year 1 and develop heart failure thereafter. The present CIRCUS II trial~     aims at examining the 3-year clinical outcome of all patients recruited in the CIRCUS study.~   "
48339|NCT02934204|"~     Consolidation treatment for Primary Central Nervous System Diffuse Large B cell~     Lymphoma(PCNSL)patients remains to be defined.Here we designed a tolerated treatment of HDMTX~     plus Temozolomide,followed by consolidation with Temozolomide in PCNSL patients.~   "
48350|NCT02934061|"~     Open label, randomized, controlled, multicenter study with two parallel groups of patients~   "
48351|NCT02934048|"~     Strongly evidence supports that H. pylori eradication is an effective approach to reduce the~     incidence of those pathologies. However, due to the increasing resistance rates to~     antibiotics, failures of H. pylori eradication get more and more common. Thus, rescue therapy~     for persistent H. pylori infection is becoming a grand challenge the investigators have to~     face.~   "
48340|NCT02934191|"~     Tonsillectomy is one of the most common pediatric surgical procedures in the United States.~     Postoperative pain is substantial, with typical regimens employing narcotic derivatives and~     acetaminophen for 1-2 weeks after surgery. Recent enthusiasm for use of ibuprofen as an~     alternative has been tempered by equivocal data on its relative safety in regard to risk of~     postoperative hemorrhage. The primary objective is to evaluate efficacy of celecoxib for pain~     control after tonsillectomy in children. The secondary objective is to assess safety in~     regard to postoperative hemorrhage and adverse events.~   "
48341|NCT02934178|"~     This is a research study about an experimental (investigational) live attenuated Shigella~     sonnei vaccine (WRSS1) to find a dose of the vaccine that is safe, tolerable, and develops an~     immune response. Shigella causes bloody and watery diarrhea, and infants and children living~     in developing countries experience the greatest consequences of this disease. The WRSS1~     vaccine in will be given to healthy toddlers (12-24 months old). The first vaccination will~     be given to toddlers in the inpatient unit and the second and third doses will be~     administered on an outpatient basis. A safety evaluation will be preformed after the first~     dose before enrolling subjects in subsequent cohorts to receive a higher vaccine dose. As of~     September 2017, the study will be close out after Cohort 1 and enrollment of Cohorts 2, 3 and~     4 will not occur.~   "
48342|NCT02934165|"~     As the leading cause of death and disability in children in America, unintentional injuries~     are a critical public health issue. Most injuries can be prevented by parents implementing~     effective child safety practices. This project produced an interactive multimedia (IMM)~     program delivered via Internet/Intranet that taught injury prevention skills to parents of~     children aged 2 through 5 years, with the ultimate goal of reducing mortality and disability~     from unintentional injury in this population.~   "
48343|NCT02934152|"~     Background: Rebound acid hypersecretion and acid-related symptoms after discontinuation of~     proton-pump inhibitor has been reported in previous studies. In patients with concurrent~     gastro-esophageal reflux disease and Helicobacter pylori infection, whether eradication of H.~     pylori will aggravate acid-related symptoms after discontinuation of proton-pump inhibitor~     (PPI) remains elusive Objective: This study aims to investigate the incidence and severity of~     acid-related symptoms after discontinuation of proton-pump inhibitor in reflux patients~     receiving H. pylori eradication Expected result: The investigators will find out the~     incidence and severity of acid-related symptoms after discontinuation of proton-pump~     inhibitor in reflux patients receiving H. pylori eradication~   "
48344|NCT02934139|"~     The present study is designed to assess the safety and tolerability of escalating, multiple~     ascending doses of Cavosonstat (N91115) in healthy subjects.~   "
48345|NCT02934126|"~     Background: The Dutch guideline on breast cancer treatment shows several grey areas, where no~     clear recommendation is given on the radiotherapy options, but where the advice is to discuss~     the treatment of choice with the patient. Currently, patients are exposed to different~     information given by the professionals' personal styles of informing patients. The challenge~     for all oncological professionals is to give clear, structured, and neutral information on~     the pros and cons of the treatment option(s) in the context of the natural course of the~     disease to the patient; to elicit patients' needs and preferences. How and which information~     should be shared in a decision aid is up for investigation, as well as how this should best~     be implemented.~      Research goals: Qualitative assessment of patients' and health care professionals'~     informational needs and perspectives on breast cancer radiotherapy and shard decision making.~      Methods: Semi-structured interviews will be held with both breast cancer patients and health~     care professionals. To reach as heterogeneous groups as possible patients of different ages,~     with different education levels and who underwent different treatments or chose not to get~     radiotherapy at all will be selected . Data will be collected til saturation is reached.~     Interviews will be transcribed verbatim and analysed using thematic analysis.~      Results: Results of the qualitative study are expected at the beginning of 2017.~      Hypothesis: Investigating the patients' and health care professionals' perspectives on shared~     decision making and informational needs on radiotherapeutic options will help the development~     of a personalized decision aid eligible for broad implementation.~   "
48346|NCT02934113|"~     The purpose of this study is to test a workplace intervention program targeted at low SES~     workers. Working in partnership with BJC HealthCare, we will test an innovative multi-level~     intervention that includes an interactive obesity treatment program (iOTA) using SMS text~     messaging. The iOTA intervention will be embedded in a newly described Healthy Workplace~     Participatory Program, which incorporates employee participation in decision making to~     produce changes in the workplace environment that are acceptable, effective, and sustainable.~     These nested interventions will be tested a large delayed-start group-randomized trial. This~     study will rigorously test readily scalable interventions that can be translated to other~     work settings to reduce obesity and diabetes risk among low SES workers, a group at high risk~     for these disorders. This pragmatic clinical trial will advance the long-term goal of~     enabling employers and employees to reduce obesity and obesity-associated illnesses including~     diabetes.~   "
48347|NCT02934100|"~     This study evaluates the effectiveness of physiotherapy and kinesiotherapy in patients with~     calcaneal spurs. the aim of the study is to compare the efficacy of calcaneal spurs treatment~     provided with extracorporeal shock wave therapy, ultrasound therapy, electric field diathermy~     associated with kinesiotherapy and sham laser in combination with kinesiotherapy. In each~     group kinesiotherapy treatment is the same and consists of an eight-minute massage of~     posterior lower leg muscles and plantar aponeurosis stretching.~   "
48348|NCT02934087|"~     This study will evaluate a randomized comparison of direct versus snare techniques for~     cannulation of contralateral gate during an endovascular aneurysm repair (EVAR) procedure.~      This information will be used to determine if primary snaring is superior to retrograde~     cannulation in decreasing procedural time and radiation exposure.~   "
48349|NCT02934074|"~     Twenty individuals who were referred to receive physiotherapy will be participants of the~     study. Participants with lower limb loss will evaluate with the following assessment tools:~     Demographic datas; age, gender, height, body mass, year, side and level of limb loss will be~     recorded. Gait parameters (step length, variation of step length) will evaluate with Gait~     Trainer Biodex 2, at participant's preferred speed.Phantom sensation and phantom pain will be~     asked as existence or not. Sensorial loss will evaluate with Semmes Weinstein Monofilaments~   "
48352|NCT02934035|"~     Major depressive disorder (MDD) affects around 7% of the population yearly. Although~     effective treatments are available, only around half of all patients participating in~     clinical trials respond to 6 to 12 weeks of antidepressant treatment. Given these high~     failure rates, the ability to predict as early as possible whether a patient is (un)likely to~     respond would be of great value, as it would enable physicians to change treatment strategies~     faster.~      Early improvement has consistently been found to be a strong predictor of later response.~     However, misclassification is still quite common, with perhaps a third of those who do not~     show early improvement going on to respond. Conversely, a substantial proportion of those who~     do show early improvement do not go on to respond. One possibility for improving the~     predictive power of early improvement is to examine individual symptoms, rather than the~     total score on a depression rating scale. Some items, for example, could reflect~     antidepressant side effects (e.g. gastrointestinal symptoms) and may not be very predictive.~      The proposed project aims to examine the relationship between early improvement in individual~     symptoms and response to antidepressants in a very large patient sample. This large sample~     size makes it possible to use more rigorous methods than previous studies, such as the use of~     cross-validation to confirm the findings. It also makes it possible to examine a large set of~     predictors, including possible interactions among early-improving symptoms and between~     symptoms and demographic factors like age and gender. The added value of individual symptoms~     over and above using the total symptom score alone will also be examined, as well as possible~     differences between different antidepressant classes.~      The project will use penalized (lasso) regression, which is well-suited to analyzing data~     with a large number of (potentially highly correlated) predictors. In the primary analysis,~     response after 6 weeks of treatment will be predicted. In secondary analyses, remission at~     week 6 and response and remission at week 12 will also be predicted.~   "
48353|NCT02934022|"~     Many patients on Highly Active Antiretroviral Therapy (HAART) are able to achieve a sustained~     response with viral loads becoming undetectable and staying undetectable, but do not have an~     increase in their CD4 counts to levels greater than 500. Adding maraviroc to the treatment~     regimen of these patients may result in an increase in their CD4 counts. As the patient would~     be continuing their prior regimen, they will likely continue with full control of viral~     replication.~   "
48354|NCT02934009|"~     The determination of fluid status in dialysis patients is a major clinical problem. In this~     study the NMR-MOUSE is used to determine if it can be used to non-invasively determine~     hydration status of the skin. This evaluation will be performed in dialysis patients and~     healthy volunteers.~   "
48355|NCT02933996|"~     Cardiac surgery usually leads to postoperative immunosuppression, which is characterized by~     predisposition to develop secondary nosocomial infections and high risk of tumorigenesis and~     development. Current studies showed that acupuncture treatment was effective on~     immunoregulation. Our previous study proved that electroacupuncture (EA) can regulate the~     innate immune system overreaction to endotoxin and reduce excessive inflammatory response~     induced by myocardial ischemia and reperfusion. However, whether transcutaneous electrical~     acupoint stimulation(TEAS) can improve immune function in patients post cardiac surgery is~     not clear. The investigators perform a randomized controlled study to evaluate whether TEAS~     treatment can improve the immunosuppression post cardiac surgery, which may provide rational~     for the development of TEAS to treat cardiac patients perioperatively.~   "
48356|NCT02933983|"~     The aim of this study is to investigate whether the microbiota in the upper respiratory tract~     (URT) (nose, nasopharynx and sinuses) of chronic rhinosinusitis (CRS) patients is disturbed~     compared to healthy individuals. Therefore, bacterial DNA from swabs, aspirates and tissue~     will be isolated via commercially available DNA extraction kits, followed by Illumina MiSeq~     sequencing in order to identify the bacterial species present in these samples. Special~     attention will go to microbial species that are overrepresented in the healthy populations as~     potential health promoting microbes (i.e. probiotics). A better understanding of the URT~     microbiome might help us to better understand the pathology of CRS and might help to develop~     new microbiota-based strategies for CRS.~   "
48357|NCT02933970|"~     To compare the effectiveness of a patient-centered, opiate agonist treatment (OAT)-integrated~     telemedicine-based approach for management and delivery of hepatitis C virus (HCV) treatment~     to persons with substance use disorders (PWSUD) versus usual care, which we anticipate in~     most cases will be referral to an offsite location for HCV management. The effectiveness will~     be expressed through the primary patient centered and clinical outcome, achievement of viral~     eradication, defined as undetectable HCV RNA 12 weeks post-treatment cessation.~   "
48358|NCT02933957|"~     Traditionally, people have always been focusing on vascular injuries by angiography. Recent~     years, the investigators have further known that the pathological foundation of various~     cardiovascular complications not only lies in the vascular lumen, but also vessel wall.~     Therefore, now it is possible to detect and prevent vascular disease early. There are many~     influencing factors on functional and structural damages of vessels, including genetic and~     environmental factors. The investigators have done many researches on populations of the Han~     nationality, which has the largest population in China. Thus, the investigators further~     wonder whether the function and structure of vessel differ in the She Minority of a remote~     southern region in China. The investigators will enroll 150 subjects of two ethnic groups~     respectively in the local population， namely She Minority and Han nationality. All subjects~     enrolled into the study will complete a questionnaire survey of the general situation and~     conduct vascular related examinations, including evaluation of arterial stiffness, arterial~     elasticity indexes, subclinical carotid atherosclerosis and biomarkers. The investigators~     will analysis vascular differences between the two populations and provide a theoretical~     basis for the specific strategies of prevention and treatment.~   "
48359|NCT02933944|"~     The purpose of this study is to determine safety and anti-tumor immune activation generated~     by TG02 and Granulocyte macrophage colony stimulating factor (GM-CSF), first as monotherapy~     (Part I), thereafter in combination with the checkpoint inhibitor pembrolizumab (Part II), in~     patients with locally recurrent rectal cancer scheduled to have surgery.~      Part I and Part II will include approximately 10 patients each. Part I and Part II are~     separate and independent sequential components of the study. Patients will only be able to~     participate in either the Part I cohort or Part II cohort.~      Main objective of the study is to investigate safety and immune response after~     TG02-treatment.~   "
48360|NCT02933931|"~     This prospective observational cohort study will follow the roughly 100 adults who received~     the VSV-ZEBOV vaccine in the Geneva phase 1 randomized controlled trial in 2014-2015 in order~     to determine their long-term (5-year) immune response to vaccination.~   "
48391|NCT02933528|"~     An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal~     Use Treatment with DSXS .~   "
48941|NCT02926339|"~     This study evaluates the efficacy of Teens Against Tobacco Use anti-tobacco presentations on~     tobacco use susceptibility in 6th through 8th grade. Students will be randomly assigned to~     either receive 3 anti-tobacco presentations or 3 presentations on a different topic,~     unrelated to tobacco.~   "
48361|NCT02933918|"~     Chronic rhinosinusitis (CRS) is one of the most common chronic diseases, affecting the~     quality of life of patients who suffer. Despite medical and surgical treatments available,~     there are a significant number of people suffering from CRS refractory to these standard~     treatments.~      A preliminary clinical trial conducted at CHUM Hôtel-Dieu, has allowed us to evaluate the~     therapeutic potential of intranasal irrigation of probiotics in patients with CRS. This~     treatment administered twice daily for 14 days was well tolerated and resulted in improved~     chronic rhinosinusitis symptoms.~      Prior to deployment on a larger scale, the safety of this therapy must be confirmed in a~     healthy population, free of sinus disease. Therefore, this study aims to assess the safety of~     the use of probiotic intranasal irrigation in healthy volunteers.~   "
48362|NCT02933905|"~     Influence of the vitreomacular interface on the progression of diabetic macular edema after~     treatment with intravitreal injection of vascular endothelial growth factor inhibitors~   "
48363|NCT02933892|"~     The investigators will conduct a randomized controlled trial that aims to compare the~     incidence of contrast-induced nephropathy between transradial- and transfemoral-access~     cardiac catheterization.~   "
48364|NCT02933879|"~     A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Multi- Site Phase 2b Clinical~     Study to Assess the Efficacy, Safety and Tolerability of 8-Week Regimens of NVXT topical~     product in Patients with Mild to Moderate Onychomycosis~   "
48365|NCT02933866|"~     A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Design, Multiple-Site, Phase III~     Clinical Study to Evaluate the Efficacy and Safety of DSXS topical product in Patients with~     Mild to Severe Scalp Psoriasis~   "
48366|NCT02933853|"~     A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting~     Insulin Aspart in Subjects with Type 2 Diabetes Mellitus~   "
48367|NCT02933840|"~     The purpose of this study is to determine the efficacy of a remote patient monitoring~     platform and alert system in reducing adverse events for hospitalized geriatric orthopedic~     trauma patients.~   "
48368|NCT02933827|"~     1. To assess the safety of allogeneic injection of expanded ADSCs to patients with Moderate~          to Severe Chronic Kidney Disease~        2. To assess the efficacy of allogeneic injection of expanded ADSCs to patients with~          Moderate to Severe Chronic Kidney Disease~   "
48369|NCT02933814|"~     This study is being done to evaluate pain management regimens following ambulatory hand~     surgery. Improved pain control may be associated with decreased complications, decreased pain~     scores, decreased opioid dependence, improved patient comfort and satisfaction, and reduced~     healthcare costs. Liposomal bupivacaine is an FDA-approved local anesthetic. There will be~     two groups. One group will receive liposomal bupivacaine. One group will not. The results~     will be compared.~      Patients will be over the age of 18 ambulatory hand surgery. Approximately 40 subjects will~     participate in this study at LLU.~   "
48370|NCT02933801|"~     The main objective of the trial is to assess impact of maintenance therapy with ODM-201 on~     radiographic progression-free survival (rPFS) of patients with mCRPC pretreated with novel~     hormonal agents who have non-progressive disease after chemotherapy with a taxane.~   "
48371|NCT02933788|"~     This study evaluates the more suitable treatment for the prevention of vascular complications~     in diabetes patents who were at high cardiovascular risk group by comparing the platelet~     aggregation inhibitory effect of aspirin and cilostazol.~   "
48372|NCT02933775|"~     This study is designed for determining the safety and relative engraftment levels of the~     redirected autologous T cells transduced with the anti-CD19 lentiviral vector in patients~     with CD19-positive B cell leukemia and malignant lymphoma.~   "
48373|NCT02933762|"~     The primary purpose of this study is to investigate the effects of JNJ-54175446 (dose~     response) on levels of Aβ fragments (Aβ1-42, Aβ1-40, Aβ1-38, Aβ1-37) in plasma and~     cerebrospinal fluid (CSF), the effects of JNJ-54175446 on markers of (neuro)~     inflammation/protection in blood and CSF and the pharmacokinetics of JNJ-54175446 followed by~     single and multiple dose administration.~   "
48374|NCT02933749|"~     The sitting or prone positions are used for posterior fossa surgery. Although the sitting~     position may cause hemodynamic instability, venous air embolism, it also provides optimum~     access to midline lesions, decreases intracranial pressure. The sitting position has not been~     only used in neurosurgery, it has been also used in the shoulder surgery. The sitting~     position related hypotension may reduce the cerebral perfusion pressure, therefore may cause~     cerebral ischemia. The sitting position related cerebral ischemia has been shown in the~     shoulder surgery. The non invasive cerebral oxymetry (INVOS-Covidien) has been used to~     measure cerebral oxygen saturation. Some studies has been done to investigate whether the~     sitting position cause cerebral desaturation or not in the shoulder surgery by non invasive~     cerebral oxymetry. The study results are controversial.~      It has been investigated that the effect of the prone position on the cerebral oxygenation in~     the spine surgery and the investigators found that the prone position may increase cerebral~     oxygenation.~      However, all studies have been done in patients without intracranial pathology. We speculate~     that due to the sitting position reduces the intracranial pressure, it may improve the~     cerebral oxygenation in the patients have intracranial pathology. Therefore we will compare~     the sitting and the prone positions effects on the cerebral oxygenation in patients~     undergoing posterior fossa tumour surgery by non invasive cerebral oxymetry.~      Method: 62 patients have posterior fossa tumour will include the study. Patients will divide~     to 2 groups according to the surgical position, the prone (n=31) or the sitting (n=31).~     Patients heart rate, mean blood pressure (MAP), cerebral oxygen saturation (SctO2),~     peripheral oxygen saturation (SpO2), BIS values will record before the induction of~     anesthesia. Five minutes after the standard anesthesia induction all values will record and~     it will accept as a baseline. After that all these parameters will record in each 3 minutes~     until the beginning of surgery. Mean while, more than 5 % reduction in SctO2 and more than 20~     % reduction in SctO2 and/or MAP will record. As well as, if the SctO2 reduces than 55 and 60~     %, it will record.~   "
48375|NCT02933736|"~     In the proposed trial, patients will be administered ribociclib prior to surgical resection~     of their tumor. Patients will be enrolled in time-intervals sequentially (non-randomized).~     All patients will be orally-administered 5 doses of LEE011 (900 mg/d) with the final dose~     occurring at one of 3 intervals before brain tumor resection.~   "
48376|NCT02933723|"~     The study is designed to evaluated if adjuvanted vaccine elicits higher T cell and B cell~     responses than non-adjuvanted standard dose influenza vaccine in nursing home residents.~   "
48377|NCT02933710|"~     The purpose of the study is to perform the re-examination of IMOJEV® in routine clinical~     settings in accordance with the Ministry of Food and Drug Safety regulation.~      Primary objective:~        -  To describe the safety profile of the first dose of IMOJEV® administered under routine~          health care visit as primary vaccination or as booster.~   "
48378|NCT02933697|"~     The Study is an open-labeled, randomized controlled trial, phase IIIb. Its objective is to~     assess the safety of the factor Xa inhibitor apixaban versus the vitamin-K antagonist (VKA)~     phenprocoumon in patients with NVAF and ESKD on hemodialysis. The safety will be assessed by~     means of the incidence of major and clinically relevant, non-major bleeding on~     anticoagulation.~   "
48406|NCT02933333|"~     The purpose of this study is to explore the effect of G-CSF combination with GM-CSF on~     prevention and treatment of infection in children with malignant tumor.~   "
48379|NCT02933684|"~     The proposed project aims to increase accessibility of exposure therapy, an evidence based~     treatment for social anxiety disorder, by adapting a therapist-assisted computer-based~     program to be delivered in a self-guided manner on an iPad. A significant problem with~     self-guided treatment delivered via computer is compliance. The vast majority of users do not~     complete treatment, so achieving therapeutic benefit as quickly as possible is essential.~     D-cycloserine is a drug found to augment response to therapist-guided exposure therapy for~     anxiety disorders, but has never been tested with self-guided exposure. This study uses a~     randomized, double-blind methodology to compare D-cycloserine (50 mg; DCS) to placebo in~     combination with self-guided virtual reality exposure therapy (VRE) delivered via iPad to~     treat social anxiety disorder. The proposed study tests the hypothesis that patients who~     receive DCS in combination with the self-guided VRE will show more improvement than those who~     receive placebo in combination with VRE. Outcome measures include self-reported symptoms of~     social anxiety, behavioral avoidance, and diagnostic remission. Participants (N=34) are~     adults with a primary diagnosis of social anxiety disorder. Participants will complete a~     structured diagnostic interview, standardized self-report measures of social anxiety, and a~     behavioral avoidance task (i.e., giving a speech) and will be assessed at pre-treatment, at~     post-treatment and at 3 month follow-up. Hierarchical linear regression and chi-square~     analyses will be used to test differences between those randomized to DCS versus placebo on~     the following outcomes: post-treatment scores of self-reported social phobia symptoms,~     willingness to and anxiety while giving a speech at post-treatment, and diagnostic remission~     at 3 month follow-up. The proposed project combines technological advances with translational~     research to develop an innovative and accessible treatment for those with social anxiety~     disorder. The pilot data generated from this study will be appealing to a variety of funding~     agencies, including the National Institute of Mental Health's call for exploratory clinical~     trials of novel interventions for mental illnesses, the Patient-Centered Outcomes Research~     Institute's call for effectiveness studies aimed to overcome barriers to treatment, and the~     National Science Foundation's call for innovation-technology translation research.~   "
48380|NCT02933671|"~     The purpose of this study is to learn if using a suprainguinal fascia iliaca (SIFI) injection~     technique (also called a nerve block) that numbs the nerves going to the side and front of~     the upper leg will improve pain control after surgery. The SIFI technique uses a numbing~     solution (local anesthetics) that is injected next to nerves in the hip to reduce pain. This~     block may affect movement in the leg and make the legs weak. The amount of leg weakness is~     not known and assessment of this will be included in the study. Many institutions use the~     SIFI block for patients having total hip replacements, with the hope of providing good pain~     relief combined with improved mobility after surgery.~   "
48381|NCT02933658|"~     A non-randomized, two-arm, single-sequence, crossover, open label, multiple oral dosing~     clinical trial to evaluate the safety and the pharmacokinetic drug-drug interaction of~     Telmisartan/Amlodipine and Rosuvastatin in healthy male volunteers~   "
48382|NCT02933645|"~     Recent research has suggested that intranasally administered insulin can reach the brain~     quickly without passing through circulation and evoke increased insulin sensitivity and~     tissue glucose consumption during insulin stimulation (low-dose hyperinsulinemic, euglycemic~     clamp). It is still not known what mechanism causes these changes or what tissues are~     involved in this.~      In this study, the changes in tissue-specific insulin sensitivity and glucose uptake will be~     investigated by using glucose-analogue radiotracer ([18F]-fluorodeoxyglucose) with positron~     emission tomography (PET) imaging during insulin stimulation. Ten healthy males are studied,~     each receiving nasal sprays containing insulin or placebo in a randomized order on two~     separate days. After spray administration, glucose uptake in skeletal muscle, liver,~     subcutaneous and visceral adipose tissue, myocardium, intestines, brown adipose tissue and~     brain assessed by PET imaging and glucose uptake in these tissues is analyzed. Endogenous~     glucose production is calculated facilitating the measurements glucose and radiotracer uptake~     in tissues and tracer loss into urine.~      As skeletal muscle consumes most of the glucose available, it is likely that administration~     of insulin sprays will result in an increased uptake in this tissue. Some increase in glucose~     uptake might also be seen in other tissue types after insulin spray versus placebo spray~     administration.~   "
48383|NCT02933632|"~     Accelerated rehabilitation protocol in Total Hip Arthroplasty (THA-AR).~   "
48384|NCT02933619|"~     Following product approval, confirmation of appropriate VF episode detection after MRI~     exposure of the ProMRI ICD/CRT-D systems and to evaluate left ventricular pacing threshold~     changes post-MRI.~   "
48385|NCT02933606|"~     This is a randomized, double-blind, placebo-controlled study, evaluating the effects of~     BNC210 versus placebo on the symptoms of Post-Traumatic Stress Disorder, as measured by the~     Clinician-Administered PTSD Scale for DSM-5 (CAPS-5).~      The secondary objectives of the study are to evaluate the effects of BNC210 on anxiety,~     depression, global functioning and patient reported outcomes in patients with PTSD. Safety~     and tolerability of BNC210 will also be assessed. Study participants will receive 12 weeks of~     blinded treatment followed by a 3 week follow-up period.~   "
48386|NCT02933593|"~     The investigators plan to monitor the central blood pressure in women with severely elevated~     blood pressures (160/110) in pregnancy in the acute setting. Currently ACOG recommends 3~     different options for blood pressure control, however no one has studied how these~     medications affect the central pressures, only peripheral blood pressure.~   "
48387|NCT02933580|"~     The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics~     (PK) of JNJ-56136379 in healthy Japanese adult participants following oral administration of~     single doses from 25 milligram (mg) up to 600 mg, in fasted conditions.~   "
48388|NCT02933567|"~     In response to the growing need for training on interventions to address first episode~     psychosis, the Center for Social Innovation (C4) has partnered with experts in Coordinated~     Specialty Care (CSC) to develop and test CSC OnDemand: An Innovative Online Learning Platform~     for Implementing Coordinated Specialty Care. The product builds on the findings of the~     Recovery After an Initial Schizophrenia Episode (RAISE) studies, funded by the National~     Institute of Mental Health (NIMH). RAISE examined team-based models of care for people early~     in the course of schizophrenia. Through a Fast Track Small Business Innovation Research~     (SBIR) grant, investigators will prototype, test, refine, and evaluate the impact of CSC~     OnDemand.~   "
48389|NCT02933554|"~     Obesity is an epidemic in the US. With progression of obesity, Nonalcoholic steatohepatitis~     (NASH) has been a growing public health issue. Presently there is no cure for NASH.Prevention~     of progression of fibrosis in NASH is crucial, as they are at a high risk for cirrhosis and~     may need liver transplant.~      Recent studies have shown that blocking blood vessels to a particular portion of the stomach~     (bariatric or left gastric artery embolization) can temporarily decrease levels of the~     appetite inducing hormone ghrelin, and result in weight loss.The purpose of this study is to~     determine if Left gastric artery embolization (LGAE) in patients with obesity and NASH leads~     to clinically significant weight loss with improvement of NASH.~   "
48390|NCT02933541|"~     Plan to monitor central arterial pressure in women who are undergoing spinal anesthesia for~     cesarean delivery or epidural anesthesia for vaginal delivery.~   "
48392|NCT02933515|"~     The long-term goal of this project is to advance best practices in occupational therapy (OT)~     to manage fall risk factors and reduce fall rates in older adults with stroke. To address~     this long-term goal, this team previously developed and pilot-tested a therapeutic yoga~     intervention to improve balance, balance self-efficacy, and fear of falling and a group OT~     intervention to improve the management of fall risk factors and fear of falling. The success~     of both prior studies supports Merging Yoga and group OT to improve balance, balance~     self-efficacy, and fall risk factor management. The objectives of this feasibility study are~     to 1) further develop, standardize, and manualize the MY-OT intervention and 2) assess change~     in balance, balance self-efficacy, and fall risk factor management.~   "
48393|NCT02933502|"~     An Open-Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal~     Use DSXS topical product (Taro Pharmaceuticals U.S.A., Inc.) in Patients with Moderate to~     SevereScalp Psoriasis~   "
48394|NCT02933489|"~     This randomized phase II trial studies how well abbreviated breast magnetic resonance imaging~     (MRI) and digital tomosynthesis mammography work in detecting cancer in women with dense~     breasts. Abbreviated breast MRI is a low cost procedure in which radio waves and a powerful~     magnet linked to a computer and used to create detailed pictures of the breast in less than~     10 minutes. These pictures can show the difference between normal and diseased tissue.~     Digital tomosynthesis mammography is a procedure that uses multiple x-rays pictures of each~     breast to produce a 3-dimensional rendering of the entire breast. Combined screening with~     abbreviated breast MRI and digital tomosynthesis mammography may be a better method to screen~     women with dense breasts.~   "
48395|NCT02933476|"~     The purpose of this study is to examine the possibility of a new, non-invasive, non-drug~     treatment for Parkinson's disease. The treatment involves gentle vibratory stimulation~     delivered to the fingertips (called 'vibrotactile stimulation'). Along with the treatment,~     participants will also undergo kinematic testing.~   "
48396|NCT02933463|"~     This study is designed to clinically evaluate the retention and development of caries when~     using self-priming (Embrace wetbond) and conventional flowable composite (Clinpro) as pit and~     fissure sealant in young first permanent molars.~   "
48397|NCT02933450|"~     The Investigator hypothesize that a single dose of patiromer will lower serum potassium~     levels in less than 6hrs. Since a dosage of 30g/day for a period of 4 weeks has been studied~     in at least two multicenter randomized controlled trials, the Investigator further~     hypothesize that a single dose of 25.2g of patiromer will be well tolerated in hyperkalemic~     patients in the Emergency Department setting. The FDA approved dosage of 25.2g is appropriate~     for this study because the research staff will enroll patients with moderate (K greater than~     6 mEq/L) to severe hyperkalemia, and the higher dosage has typically been used in this~     population for more effective control.~   "
48398|NCT02933437|"~     Standard, high lead and sodium channel provoked electrocardiograms of a healthy volunteers~     will be performed to observe the various ECG changes. Participants will the undergo detailed~     imaging with cardiac magnetic resonance imaging and deep genotyping to identify structural or~     genetic variants which might dictate the electrocardiographic patterns at rest and with~     sodium channel provocation.~   "
48399|NCT02933424|"~     The objective of this study is to compare the effects of adding three plant-based proteins~     (rice, oats and pea proteins) to a breakfast beverage on the glycemic response, appetite and~     subsequent food intake of healthy adults.~   "
48400|NCT02933411|"~     This is a research study for patients diagnosed with heavy menstrual bleeding (HMB) and low~     Von Willebrand Factor (VWF). Menstruation, also known as a period, is the regular discharge~     of blood and tissues from the uterus. HMB is having a heavier amount of discharge during~     menstrual period. Low Von Willebrand Factor means that the participant has lower level of a~     blood protein that is important for clotting of blood and so, the participant is at a higher~     risk for bleeding.~      The purpose of this project is to study the genetic differences of adolescent females with~     HMB and low VWF activity and compare the genetic differences with their bleeding~     manifestations, response to medications and outcome.~   "
48401|NCT02933398|"~     A prospective, randomized, controlled trial including patients who are diagnosed with a small~     renal mass (<4 cm) amenable to resection using either RALPN or LPN.~   "
48402|NCT02933385|"~     Currently there are very few efficacy studies that integrate classical interventions~     (screening clinics) and online tools in order to obtain sustainable lifestyle changes in~     workers. The current project aimed to evaluate l'efficiency of a combined approach versus~     more traditional approaches. Health Data collected by CAPSANA in the workplace between 2012~     and 2014 showed that, out of 4231 workers, 69% should aimed at a more active lifestyle and~     74% at a better nutrition profile. In addition, 53% of the sampled population was overweight.~     In this context, the current project aimed to motivate and follow individuals towards a~     healthier lifestyle. To do so, the Défi Santé Plus+ will be implemented and tested using~     various versions (light to more complete) in several compagnies.~   "
48403|NCT02933372|"~     Varying oral doses of Varenicline (VCN), starting with very low doses, will be administered~     to participants with Parkinson's Disease (PD) for several days. Positron emission tomography~     (PET) scans after administration of VCN will be used to determine the lowest oral dose of VCN~     producing an adequate brain level of VCN. With an appropriate oral dose of VCN identified,~     the investigators will administer VCN to PD participants to determine if VCN improves walking~     speed and measures of balance. VCN will receive VCN or a placebo (fake drug) for 3 weeks to~     assess the effects of VCN administration on gait speed and balance. Participants will undergo~     examinations to assess the intensity of their Parkinsonism and asked questions to assess~     their mood and thinking.~   "
48404|NCT02933359|"~     The primary objectives of this study are:~      i) to procure human calvarial bone, ii) to grow cells from these tissues in vitro, iii) and~     to evaluate the osteogenic potential of these cells.~   "
48405|NCT02933346|"~     Our study sought to examine nivolumab efficacy and safety in advanced NSCLC patients treated~     under the Temporary Authorization for Use (ATU, compassionate use) setting and describe their~     long-term clinical characteristics, notably the treatments they received after nivolumab~     discontinuation. The profile of these patients shows greater conformity to that of a~     non-selected population, yet the clinical data collection does not reflect real life~     conditions and stops when treatment ends, which does not enable us to get an overview of~     post-immunotherapy treatments.~   "
48408|NCT02933307|"~     Rationale: Monitoring patients' vital signs is done to detect clinical deterioration. For~     this, the MEWS, a scoring list comprising seven vital signs measured by nursing staff, is~     used. Although the MEWS provides relevant data on patients' health status, the interval~     measurements may not capture early deterioration of vital signs, especially during the night.~     As a result, unsafe situations may occur such as periods of low oxygen saturation and cardiac~     arrhythmias, which are known to complicate postoperative course. Besides, this way of~     measuring vital signs may be stressful for patients and disturbs patients' sleep. New~     technology such as ViSi Mobile and HealthPatch allows for remote continuous monitoring of~     vital signs using wearable devices transmitting relevant data to nurses and clinicians. With~     this, the investigators think that clinical deterioration may be detected in an early phase~     and reduce nurse work load and patient distress.~      Objective: to investigate the feasibility of wearable devices on the general ward.~      Study design: feasibility study.~      Study population: adult patients hospitalized on the internal medicine ward and adult~     postoperative patients on the surgical ward.~      Intervention: patients in the intervention groups will be randomized in one of the two~     groups. Patients in the group 1 will wear ViSi Mobile; patients in group 2 will wear the~     HealthPatch. Wearable devices will be worn for at least three days. Regular MEWS measurements~     take place at usual time points.~      Main study parameters/endpoints: Evaluation with patient and care givers (primary outcome~     measure), MEWS calculations, time between alarm (continuous data) and next regular MEWS~     measurement (nurse), intervention by nurse after alarm, admission to ICU, complications, side~     effects of devices, STAI scores, and PCS scores will be documented.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: Patients will wear one device for at least three days. Devices can be~     uncomfortable by being heavy or the patches can start itching. More measurements by nurses~     can take place when indicated, for example after alarms. The participating patients will fill~     out the STAI on daily basis and the PCS on the last day of hospitalization. Both~     questionnaires will take a few minutes to complete. Patients could benefit from early~     detection of clinical deterioration and early corrective interventions or ICU admissions.~   "
48409|NCT02933294|"~     Lung cancer is one of the most common cancers in the world. At present, surgical resection is~     still the standard treatment for early stage lung cancer. Triportal thoracoscopic lung~     resection is a routine surgically procedure for early stage lung cancer while uniportal~     thoracoscopic lung resection is developing rapidly in recent years. Although uniportal VATS~     pulmonary resection has been proven to be effective in preventing postoperative morbidities,~     there is still no ample evidences to demonstrate that uniportal VATS pulmonary resection is~     equal or superior to traditional triportal thoracoscopic pulmonary resection. The purpose of~     this multicenter randomized controlled trial study is to compare the uniportal VATS with~     traditional triportal VATS pulmonary resection in postoperative complications, long-term~     survival, lymph node dissection and local recurrence.~   "
48410|NCT02933281|"~     MTBVAC at four dose levels: 5 x 10^3 CFU, 5 x 10^4 CFU, 5 x 10^5 CFU, and 5 x 10^6 CFU. The~     active control is BCG (5 x 10^5 CFU). Participants will receive a single dose of MTBVAC or~     BCG revaccination administered intradermally on Study Day 0.~   "
48411|NCT02933268|"~     DRINK is an open-label randomised controlled feasibility trial of high versus ad libitum~     water intake in ADPKD.~   "
48412|NCT02933255|"~     Background:~      The immune system is the cells and organs in the body that recognize and fight infection and~     cancer. The PROSTVAC vaccine might teach the immune system to find and kill certain prostate~     cancer cells. Nivolumab is a drug that allows the immune system to fight tumors. Itmight help~     PROSTVAC work better.~      Objective:~      To test the safety and effectiveness of the combination of PROSTVAC and nivolumab. To test~     this for people with castration resistant prostate cancer and then for other people with~     localized prostate cancer who are candidates for surgical removal of the prostate.~      Eligibility:~      Men ages 18 and older with prostate cancer~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Blood and urine tests~      Electrocardiogram~      Bone scan~      CT scan or MRI~      Tumor sample. This may be from a previous procedure.~      All participants will get a combination of the study drugs over 8 weeks. They will have 1~     visit for the initial injection then 3 booster injection / nivolumab infusion visits. Blood~     will be tested at these visits.~      Over the next 4 weeks, some participants will have:~      An exam of the large intestine through the rectum.~      CT and bone scans~      Standard hormonal treatment~      Option to continue treatment every 3 weeks if their disease does not get worse. They will be~      have scans every 12 weeks.~      Other participants will have surgery to remove the prostate in week 9.~      Participants will have a safety visit about a month after their last treatment. This will~     include a physical exam, blood tests, and possibly scans.~      If their cancer progresses, participants will leave the study and may enroll in a long-term~     follow-up study. They will be contacted once a year to ask about their cancer and treatment.~   "
48413|NCT02933242|"~     This is a study measuring toxicity while making observations about the survival benefits of~     treating participants with oligometastatic disease using stereotactic ablative radiotherapy~     (SABR).~   "
48414|NCT02933229|"~     Helicobacter pylori (H. pylori) infection, affecting an estimated 50% of the global~     population, is a main cause of chronic gastritis, peptic ulcers and gastric cancer. By~     causing progressive damage to the stomach and may eventually result in gastric atrophy, H.~     pylori infection has been demonstrated to be responsible for more than 95% of gastric~     malignancies~   "
48415|NCT02933216|"~     Cesarean scar diverticula (CSD) is a novel recognized cause of postmenstrual abnormal uterine~     bleeding in women. No clinical guidelines have been issued for the management of CSD.~     Currently, several limited surgical management procedures for CSD have been reported, such as~     hysteroscopic combined with laparoscopic excision (abbreviated as hysteroscope + laparoscope)~     and vaginal repair of CSD (abbreviated as VR). However, which management can achieve better~     clinical effects remains unknown. Therefore, this prospective study is designed to compare~     the therapeutic effects between VR and hysteroscope + laparoscope in the treatment of CSD.~   "
48416|NCT02933203|"~     The purpose of this study is to examine whether stress predicts telomere length in~     individuals who hold executive-level positions. Telomeres are the caps at the end of each~     strand of DNA that may affect how cells age. Subjects will complete an online~     survey/interview and provide one blood sample or saliva samples. The goal is to understand~     whether stress predicts genetic markers of longevity.~   "
48417|NCT02933190|"~     To investigate the fertility in patients after treatment by transvaginal surgery or uterine~     artery embolization combined with uterine curettage~   "
48442|NCT02932865|"~     Men are recruited to collect seminal plasma samples and serum samples from men with~     azoospermia, men receiving medical treatment of infertility and men attending semen analysis.~     MicroRNA (miRNA) and PiWi-interacting RNA (piRNA) are analyzed for all of the groups to find~     potential differences. Steroid hormones are analyzed by liquid chromatography-tandem mass~     spectrometry.~   "
48942|NCT02926326|"~     An open-label, single-sequence study to evaluate the effect of azithromycin on BCT197~     exposure in healthy male subjects.~   "
48418|NCT02933177|"~     In order to offer a non-drug intervention for caregivers in nursing home to respond promptly~     to a behavioral crisis with an appropriate response to each patient, a chariot has been~     developed by the Institute of Ageing Well Korian (Institut du Bien Vieillir Korian) to bring~     together eleven mediation activities. These activities lasting about 15 minutes are based on~     emotion (reminiscent, games) and sensory interventions (music, massage, touch) to~     decentralize patient stimulus that disturbs and focus on a subject not disruptive. This~     emergency intervention should provide a reduction in Behavioral and Psychological Symptom of~     Dementia (BPSD) of nursing home patients. The main objective is to measure its immediate~     effect on productive symptoms (agitation, aberrant motor behavior and disinhibition). The~     secondary objectives are to measure its immediate impact on the well-being and psychotropic~     treatments, and measure its effect after two months and after four months on all BPSD with a~     focus on agitation, the administration of psychotropic drugs, the hospitalizations and the~     number of falls.~   "
48419|NCT02933164|"~     The purpose of this clinical investigation is to evaluate the effectiveness of modified~     Sensor designs on the longevity (up to 180 days) of the Senseonics Continuous Glucose~     Monitoring (CGM) System. The investigation will also evaluate safety of the Senseonics CGM~     System usage, while in the clinic and during home use.~   "
48420|NCT02933151|"~     To conduct a pragmatic randomized clinical trial in which the researchers will determine the~     mortality impact of a protocol whereby all hemodialysis patients receive an oral,~     protein-based nutritional supplement during the dialysis procedure as compared to the~     existing nutritional protocol whereby only hemodialysis patients with serum albumin below 3.5~     g/dL and incident hemodialysis patients during the first months of care receive an oral,~     intradialytic protein-based nutritional supplement during the dialysis procedure.~   "
48421|NCT02933138|"~     Purpose: The mechanism of most of the multifactorial chylomicronemia (MCM) remains elusive.~     In order to decipher the mechanisms involved in the occurrence of this disease, plasma TG~     lipolysis characteristics will be monitored for 60 minutes after heparin injection instead of~     the 10 minutes gold standard, in a large group of genotyped MCM patients.~   "
48422|NCT02933125|"~     Background: Substance abuse among children and adolescents is an important public health~     issue in Taiwan. Kaoshiung Chang Gung Memorial Hospital and Taiwan Kaoshiung Juvenile and~     Family Court will cooperate in a counseling program for adolescents with illicit drug abusers~     in 2013, to perform a mandatory 10-week family-based group psychotherapy.~      Aims: This study aims (1) to investigate the effectiveness of the family-based group~     psychotherapy for adolescents with illicit drug abusers and their parents; (2) to identify~     whether the counseling program is effective for preventing the adolescents from relapse of~     substance abuse.~      Expected Results: The investigators expect that (1) group psychotherapy may involve~     comprehensive benefits for adolescents with illicit drug abusers, by improving the changes in~     adolescents' substance-craving symptoms and behavioral problems, and reducing stress of their~     parents; (2) this counseling program is effective for preventing the adolescents from relapse~     of substance abuse; (3) the findings in this study will not only demonstrate empirical~     evidence of treatment effectiveness for adolescents with illicit drug abuse, but will also~     provide useful clues for future implementation of policy making.~   "
48423|NCT02933112|"~     The purpose of the study is to test the workflow of an auto-titrating mandibular positioner~     in its intended setting. Participants with obstructive sleep apnea will use the device to~     determine their eligibility for oral appliance therapy and provide feedback on usability of~     the device.~   "
48424|NCT02933099|"~     To compare the antiemetic combination of palonosetron, dexamethasone, and aprepitant (PDA)~     with antiemetic combination of palonosetron and dexamethasone (PD) in nasopharyngeal~     carcinoma patients receiving docetaxel, cisplatin, and 5-FU based chemotherapy.~   "
48425|NCT02933086|"~     The relevance of this study is given by the feasibility to assess the effect of an~     intervention program based on the functionality and trunk neuromuscular activity and postural~     control in pregnant women with low back pain. The main outcomes will be computed by~     electromyography measurement so that to assess the trunk neuromuscular activation pattern as~     well as by force platform parameters for determining of postural control. Clinical symptoms~     such as pain intensity, perception of disability and fear and avoidance will also be~     computed. This is the first study to compare two intervention methods using the main~     biological outcomes related to trunk segment function.~   "
48426|NCT02933073|"~     This is a Phase I trial to test the safety and feasibility of OncoImmunome vaccine in stage~     III/IV ovarian cancer patients. OncoImmunome is a tumor specific vaccine formulation which is~     predicted to elicit tumor-protective immune responses. A total of 15 patients will be~     enrolled from the Principal Investigator (PI) clinical practice. These patients will have~     just successfully completed standard of care surgical debulking with preservation of fresh~     tumor, chemotherapy treatment and be in documented clinical remission prior to receiving the~     vaccine. The patients receive 6-monthly doses of the vaccine and are monitored for up to 5~     years post vaccination. This is a personalized vaccine, unique to each patient and is the~     first in human use.~   "
48427|NCT02933060|"~     The purpose of this study is to determine whether patients in the emergency department with~     migraine headache who are administered an intravenous fluid bolus will report greater~     improvement in pain scores than control patients.~   "
48428|NCT02933047|"~     Laparoscopic Hysterectomy (LH) is increasingly used as a standard surgical approach to~     hysterectomy. It is a safe procedure with low rates of complications and readmissions.~     Increasing evidence indicates that LH may be suitable for an outpatient setting but this may~     impair patient's satisfaction in more than 25% of cases. In addition, change from in-patient~     care to day case surgery might influence readmission rates and postoperative physical~     activity. No data are available on the current length of sick leave in Danish patients after~     hysterectomy, and the effects of outpatient surgery on this parameter are difficult to~     predict. A randomized controlled trial of LH performed as an outpatient procedure compared~     with today's inpatient standard will provide a firm platform for future planning of routine~     treatment of patients with need of hysterectomy for benign indications.~   "
48429|NCT02933034|"~     The purpose of this study is to evaluate the safety and tolerance of a new intravenous~     diagnostic agent , SeeMore or EVP 1001-1, in patients with Cardiovascular Disease. The~     initial phase of this study, NCT01989195 enrolling a total of 6 patients, has been closed.~     This second phase adds 10 patients in a safety cohort and 60 additional patients for a total~     of 70 patients.~   "
48431|NCT02933008|"~     Traumatic, debilitating anterior cruciate ligament (ACL) injuries occur at a 2 to 10-fold~     greater rate in female than male athletes. Consequently, there is a larger population of~     females that endure significant pain, functional limitations, and radiographic signs of knee~     osteoarthritis (OA) within 12 to 20 years FOLLOWING injury. To reduce the burden of OA, The~     National Public Health Agenda for Osteoarthritis recommends expanding and refining~     evidence-based prevention of ACL injury. Specialized training that targets modifiable risk~     factors shows statistical efficacy in high-risk athletes; however, clinically meaningful~     reduction of risk has not been achieved. A critical barrier that limits successful training~     outcomes is the requirement of qualified instructors to deliver personalized, intuitive, and~     accessible feedback to young athletes. Thus, a key gap in knowledge is how to efficiently~     deliver objective, effective feedback during training for injury prevention. The~     investigators long-term goal is to reduce ACL injuries and the subsequent sequela in young~     female athletes. The overall objective of this proposal is to implement and test innovative~     augmented neuromuscular training (aNMT) techniques to enhance sensorimotor learning and~     reduce biomechanical risk factors for ACL injury. The rationale that underlies this proposal~     is that, after completion, the investigators will be equipped to more effectively deliver~     biofeedback and decelerate the trend of increasing ACL injury rates in female athletes. This~     contribution will be significant for the reduction of the long-term sequel following ACL~     injury in young females.~   "
48432|NCT02932995|"~     The purpose of this study is to evaluate the efficacy of a novel dual drug-eluting stent (DXR~     stent), which slowly releases both cilostazol and paclitaxel, for strut coverage,~     malapposition, and thrombus formation, assessed by an optical coherence tomography.~   "
48433|NCT02932982|"~     Dyspnea and chest pain represent 1.5% of general practice consultations. They may be a sign~     of many diseases, potentially serious. The concept of Gut Feelings brings a sense of alarm~     and reinsurance. The sense of alarm reflects a sense of mistrust about the patient's clinical~     situation, in the absence of objective argument. The sense of reinsurance reflects a sense of~     confidence about the patient's situation, in the absence of objective argument. Gut Feelings~     plays a key role in the diagnostic reasoning in general practice. A questionnaire measuring~     the Gut Feelings was validated in French after a linguistic validation procedure.~   "
48434|NCT02932969|"~     The purpose of this Phase 1 study is to evaluate the safety, tolerability, PK, and~     pharmacodynamics (PD) of BMS-986231 in healthy Japanese and Non-Asian participants. There is~     no formal hypothesis to be statistically tested.~   "
48435|NCT02932956|"~     This study enrolls patients who have a type of cancer with GPC3-positive solid tumors. The~     cancer has come back, has not gone away after standard treatment or the patient cannot~     receive standard treatment. This research study uses special immune system cells called GAP T~     cells, a new experimental treatment.~      The body has different ways of fighting infection and disease. No single way seems perfect~     for fighting cancers. This research study combines two different ways of fighting cancer:~     antibodies and T cells. Antibodies are types of proteins that protect the body from~     infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special~     infection-fighting blood cells that can kill other cells, including cells infected with~     viruses and tumor cells. Both antibodies and T cells have been used to treat patients with~     cancers. They have shown promise, but have not been strong enough to cure most patients.~      Investigators have found from previous research that they can put a new gene into T cells~     that will make them recognize cancer cells and kill them. In preclinical studies, the~     investigators made several genes called a chimeric antigen receptor (CAR), from an antibody~     called GC33 that recognizes glypican-3, a proteoglycan found on solid tumors (GPC3-CAR). This~     study will test T cells genetically engineered with a GPC3-CAR (GAP T cells) in patients with~     GPC3-positive solid tumors.~      The GAP T cells are an investigational product not approved by the Food and Drug~     Administration.~      The purpose of this study is to find the biggest dose of GAP T cells that is safe, to see how~     long they last in the body, to learn what the side effects are and to see if the GAP T cells~     will help people with GPC3-positive solid tumors.~   "
48436|NCT02932943|"~     This study will evaluate the efficacy, safety, and tolerability of rapastinel 450 mg compared~     to placebo adjunctive to antidepressant therapy (ADT) in patients with major depressive~     disorder (MDD) who have a partial response to ADT.~   "
48437|NCT02932930|"~     The original concept of a quadratus lumborum block (QLB) indicated for analgesia after~     abdominal surgery was first described by Blanco in 2007. Also referred to as a posterior~     transversus abdominis plane (TAP) block, the QLB consists in deposition of local anesthetic~     on either the posterior or the anterolateral border of the quadratus lumborum muscle. TAP~     blocks have already been proved effective in urologic, abdominal, and gynecologic procedures~     by blocking the sensory nerve supply to the anterior abdominal wall thus reducing the amount~     of postoperative analgesic medication. The main advantages of QLB compared to the TAP block~     is a wider sensory block area and a longer duration of analgesia. This is due to the~     extension of local anesthetic agents beyond the TAP plane to the thoracic paravertebral~     space(4).~      Previous reports have shown that QLB is effective in providing pain relief after various~     abdominal operations. However, there are no published reports on QLB for postoperative pain~     after abdominoplasty. This prospective, randomized, double-blinded, controlled study aims to~     evaluate the analgesic efficacy, opioids consumption and quality of recovery of QLB in~     patients undergoing abdominoplasty. Patients scheduled to have abdominoplasty will be~     randomized to receive bilateral QLB with either ropivacaine 0.2% or normal saline.~     Post-operative cumulative analgesic medication consumption, pain severity at rest and on~     movement, as well as quality of recovery will be evaluated and compared in both groups.~   "
48438|NCT02932917|"~     Place-based cues can be an important trigger of smoking behavior, therefore the investigators~     wish to learn more about the influence of the built environment on individual smoking~     behavior. This is to facilitate dynamic support during the post-quit phase. MapMySmoke is a~     mobile phone application that enables the capture of spatial data during smoking and craving~     events. These data will be used to create individualized support plans via the app.~   "
48439|NCT02932904|"~     The purpose of this study is to evaluate the effect of vortioxetine (10 and 20 mg, once~     daily) versus paroxetine (20 mg, once daily) on sexual functioning in healthy participants~     after 5 weeks of double-blind treatment.~   "
48440|NCT02932891|"~     An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following~     Treatment with DSXS in Patients with Atopic Dermatitis~   "
48443|NCT02932852|"~     Transplantation of cellularized human cornea impregnated and populated by mesenchymal stem~     cells derived from the patient's adipose tissue. The purpose of the study is to assess the~     safety, tolerability, and preliminary efficacy of transplantation of a single dose of~     autologous mesenchymal adipose tissue derived adult stem cells (ADAS) cellularized into~     laminas for subjects with corneal defects. 3 groups will be included in the study: (1)~     transplantation of ADAS alone without scaffold, (2) transplantation of scaffold (human~     corneal decellularized lamina) without ADAS, and (3) transplantation of ADAS cellularized on~     scaffold (the human corneal decellularized lamina)~   "
48444|NCT02932839|"~     This study aims to uncover the neuronal bases of epilepsy by recording the activity of single~     neurons in the brain of patients with epilepsy who are candidates for assessment with~     intracranial electroencephalography (EEG). A micro-electrode array will be inserted into the~     brain in addition to the standard intracranial EEG electrodes for up to 4 weeks.~   "
48445|NCT02932826|"~     The purpose of this study is to investigate the safety and therapeutic effect of ex-vivo~     expanded umbilical cord blood regulatory T cells on autoimmune diabetes.~   "
48446|NCT02932813|"~     The aim of this study is to examine the effects of a translational health in nutrition and~     kinesiology (THINK) after school program on physical variables, nutrition and exercise~     knowledge base/behaviors, and exercise enjoyment and confidence.~      Partnering with the YMCA investigators in the Kinesiology and Sport Sciences department at~     the University of Miami will set up the after-school THINK program offered three afternoons~     per week for nine months in two experimental and two control schools. The schools will~     consist of minority elementary school students (predominantly Hispanic and Black) in the~     South Florida area. The control schools will receive baseline, mid-year and follow-up testing~     nine months later, but will not go through the THINK program. They will instead go through~     their standard YMCA after school Sports, Play, and Active Recreation for Kids (SPARK)~     program.~   "
48447|NCT02932800|"~     Context: The central venous catheter is used in intensive care units for several indications,~     including the administration of drugs with sclerosis potential, infusion solutions and~     hemodynamic monitoring. It can be accessed by per cutaneous puncture using the Seldinger~     technique, which is an extremely common procedure in intensive care units. The displacement~     or accidental removal of central venous catheter caused by poor fixation have received little~     attention, but imply potentially life threatening caused by the complications which can~     result from the removal of the catheter and the need for reinsertion. Among these~     complications, can mention the interruption of vital therapies (inotropic and vasopressor~     drugs) and hemorrhagic shock. In fixing the catheter, the literature is not sufficient to~     assess whether sutures, staples or tapes are associated with a higher risk of infections.~     Objective: To compare the efficiency in fixing the short stay central venous catheter using~     the Ballerina technique associated with flap fixation to the usual fixation technique and~     to observe differences in colonization of microorganisms on the device insertion site.~     Methods: The investigators propose an individual study, analytical, intervention,~     longitudinal, prospective, controlled clinical trial and randomized to be developed in the~     Intensive Care Unit Adult Clinical and Surgical of The Samuel Libânio Clinical Hospital in~     The University of Sapucaí Valley and Intensive Care Unit Adult Clinical and Surgical of The~     Hospital e Maternity Santa Paula. After admission of the patient in the Intensive Care Unit~     and obtaining informed consent and informed, with indication of the short stay central venous~     catheter, the patient will be allocated through a table of random numbers for the groups:~     Habitual Fixation (n = 31) and Fixation with ballerina technique and flip (n = 31). The~     participants will evaluate fixation efficiency and colonization of the device's insertion~     site.~   "
48448|NCT02932787|"~     The purpose of this study was to look at the effects that height-adjustable workstations on~     occupational sitting time and workplace productivity in office workers. Participants~     workplace activity (sitting, standing and walking) and productivity was measured before the~     installation of the height-adjustable workstations. Workplace activity and productivity were~     then measured four weeks after the installation of height-adjustable workstations and four~     weeks after the removal of height-adjustable workstations, where possible. The results were~     compared to a control group who received no intervention whilst the intervention had the~     height-adjustable workstations.~   "
48449|NCT02932774|"~     The objective of this clinical trial was to assess the efficacy and safety of cetirizine HCl~     syrup vs. loratadine syrup vs. placebo syrup in the treatment of SAR in children 6 to 11~     years old.~   "
48450|NCT02932761|"~     Cesarean scar diverticula (CSD) is a novel recognized cause of postmenstrual abnormal uterine~     bleeding in women. No clinical guidelines have been issued for the management of CSD. The~     investigators have previously demonstrated that vaginal repair of CSD was an relative~     effective treatment of CSD. However, only 28.2% of the CSD patients normalized to less than 7~     days of menstruation, whereas 51.2% of women had 7 to 10 days of menstruation at 6 months~     post vaginal repair. Postoperative menstruation may contribute to surgical site infections,~     which may subsequently affect the healing of uterine scars. Treatment CSD patients with~     gonadotropin-releasing hormone agonist (GnRHa) may has the potential to improve therapeutic~     effects of vaginal repair. Therefore, the current multiple-center randomized controlled trial~     was designed to evaluate whether the application of GnRHa in combination with vaginal repair~     could achieve better clinical effects than those achieved by vaginal CSD repair alone.~   "
48451|NCT02932748|"~     The goal of this study is to evaluate the effect of three weight management interventions~     (group phone conference calls, individual phone calls, and enhanced usual care) on weight~     across 18 months in overweight and obese adults recruited through and treated by rural~     primary care clinics.~   "
48452|NCT02932735|"~     Gastric intestinal metaplasia (GIM) is an important premalignant lesion for gastric cancer.~     Precisely surveillance of patients with GIM may result in early detection and improved~     prognosis. Though important, it is not necessary to recommend surveillance endoscopy for all~     patients with GIM, since the progression rate to gastric cancer within 10 years is only 1.8%~     in those patients.~   "
48453|NCT02932722|"~     This study involves research using human subjects (cardiac surgical patients) to evaluate the~     effect of remote ischemic preconditioning (RIPC) on cardioprotective outcomes. RIPC applied~     to upper or lower extremities has been shown cardioprotective role by lowering release of~     cardiac troponin in patients with cardiac diseases. However, it is not clear whether~     anesthetics, such as propofol or sevoflurane, may impair the cardioprotective effect of RIPC~     in cardiac surgical patients. Therefore, the purpose of the study is to compare the effects~     of anesthetics on cardioprotection of RIPC in patients undergoing cardiac surgery.~   "
48465|NCT02932566|"~     This randomised, double-blind, placebo-controlled, phase 2 study aims to evaluate the~     efficacy and safety of the anti-fibrotic drug pirfenidone in the treatment of patients with~     heart failure and preserved left ventricular ejection fraction (HFpEF). Participants will be~     randomised to receive either pirfenidone or placebo, for a period of 12 months.~   "
48454|NCT02932709|"~     Attempted suicide is a major public health problem, and the efficacies of current postvention~     protocols vary. The investigators evaluated the effectiveness of telephone follow-up of~     patients referred to an emergency psychiatric unit for attempted suicide on any further~     attempt/s over the following year.~      In a single-center, controlled study with intent to treat, they evaluated the efficacy of a~     protocol of telephone follow-up of patients at 8, 30, and 60 days after they had been treated~     for attempted suicide. For comparison, they evaluated as controls patients with similar~     social and demographic characteristics referred to their emergency psychiatric unit in the~     year prior to the study who did not receive telephone follow-up after their initial~     hospitalization. Data were analyzed using logistic regression.~   "
48455|NCT02932696|"~     The main goal of our project is to study and describe the effect of exercise training on~     systolic and diastolic myocardial function assessed by 2D ultrasound strain after myocardial~     infarction.~      Our working hypothesis is that the intrinsic myocardial contractility and relaxation assessed~     by global longitudinal strain in phase II (or 2D strain) during post-infarction exercise~     training will be improved compared to baseline values as well as compared to values in a~     no-training group. Should this hypothesis prove true, it would help explain the improvements~     in functional capacity observed during the post-infarction period and after exercise~     training.~   "
48456|NCT02932683|"~     This study was designed to evaluate if MedNav impacts the ability of novice resuscitators to~     perform Neonatal Life Support (NLS) in the simulated environment, and if this ability is~     maintained after a 7 week period. Testing the nul hypothesis that there is no difference in~     technical skill completion when performing neonatal resuscitation on a mannequin with or~     without MedNav, immediately after training or after a period of 7 weeks since the training~     episode.~   "
48457|NCT02932670|"~     The aim of this study is to determine the minimum effective volume of lidocaine in 90% of~     patients (ED90) required for single-injection US-guided costoclavicular infraclavicular.~   "
48458|NCT02932657|"~     Cystic fibrosis is so far a disease whose treatment remains essentially symptomatic care~     teams perceive the boundaries of a support mainly focused on drug treatments. The patient had~     no other choice but to learn to live with their disease, the goal is to make every effort so~     that tames the disease while maintaining high self-esteem that gives meaning to his life,~     allowing, among other things, a good grip of treatment.~      Through this research we hope to encourage the integration of art therapy in the course of~     care of cystic fibrosis patients, from children to adults before and after transplantation,~     in connection with the patient education and counseling~   "
48459|NCT02932644|"~     The aim of the study is to evaluate cardiovascular events during long-term follow-up in~     Rheumatoid Arthritis. The primary outcome any cardiovascular event will be evaluated using~     systematic audits of patient records, and will be associated to low levels of vitamin D at~     baseline, to investigate the hypothesis that low levels of vitamin D can be part of a~     prediction model for cardiovascular disease in Rheumatoid Arthritis.~   "
48460|NCT02932631|"~     It is estimated that worldwide, about 15 million people are affected by vascular accident~     (CVA) per year, and in Brazil, the stroke is a major cause of death and disability,~     generating too much economic and social impact by generating motor sequelae , sensory and~     cognitive arising from blockage or rupture of blood vessels. Among the motor sequelae is the~     hemiparesis, which affects about 80% of cases with consequent impairment of the quality of~     life of individuals. However, physical therapy has shown to facilitate return of the function~     of these individuals, while minimizing the sensorimotor deficits for promoting neuronal~     plasticity through the motor relearning. Among the features of physical therapy are the~     conventional physical therapy techniques, Therapy and Restriction of Movement Induction~     (TRIM) and the Mental Practice. In view of this, the objective of the study is to compare the~     application of conventional physiotherapy protocols and TRIM and / or mental practice on the~     morphometric features, functionality and quality of life of post-stroke hemiparetic subjects~     in the chronic phase. 60 volunteers will be selected, of both sexes, aged between 45 and 80~     years with a clinical diagnosis of stroke, with hemiparesis in the chronic phase were divided~     into four groups (N = 15): control group (CG), TRIM Group (GT), Mental Practice group (GPM)~     and group TRIM + Mental Practice (GTPM) to perform specific exercises for each group for~     three times a week, totaling 24 sessions. Volunteers will be evaluated in four times through~     the Fugl-Meyer Assessment scale (FMA) adapted and Motor Ability Test of the Upper Limb~     (THMMS) and to assess the Quality of Life will be used Quality Scale Specific Life Vascular~     Accident brainstem (EQVE-AVE) and oxidative stress analysis by collecting blood and~     electromyography for muscular activity. After the research data will be tabulated on an Excel~     spreadsheet to perform intergroup and intragroup comparisons between the four evaluation~     times, which will be used for data analysis the BioEstat® 5.2 program, the choice of tests~     for analysis dependent on the statistical distribution types found and the homogeneity of~     their variances.~   "
48461|NCT02932618|"~     The purpose of this study in pediatric participants (<18 years of age) with severe hereditary~     von Willebrand disease (VWD) is:~        1. To assess the efficacy, safety, and tolerability of recombinant von Willebrand Factor~          (rVWF), with or without ADVATE, in the treatment and control of nonsurgical bleeding~          events~        2. To assess the efficacy and safety of rVWF with ADVATE during elective or emergency~          surgery~        3. To determine the pharmacokinetic (PK) profile of rVWF~   "
48462|NCT02932605|"~     The main objective of this study is to compare microglia activation as measured with PET in~     combination with the tracer [11C]-R-PK11195 between recent-onset schizophrenia patients who~     are randomised to CBD and those randomised to placebo.~   "
48463|NCT02932592|"~     To evaluate the glycemic variations during acute coronary syndrome in non-diabetic patients~     (euglycemic, or with impaired fasting glucose, or with impaired glucose tolerance)~   "
48464|NCT02932579|"~     Opioid analgesics are the most common postoperative pain medications used among dentists in~     the United States.Although these medications are highly effective in the postoperative dental~     pain management, not all patients optimally benefit from this therapy. Many suffer adverse~     consequences such as nausea, emesis, and psychomotor impairment, and there is a high~     prevalence of opioid prescription misuse among substance abusers within the dental patient~     population.~      The use of non-opioid analgesics including ibuprofen and acetaminophen in the management of~     postoperative dental pain has demonstrated equivalent or superior analgesic effects compared~     to opioid analgesic therapies, typically with significantly less adverse effects.However,~     despite these results, dentists have encountered a high variability in the success of~     non-opioid analgesic responses among the postoperative dental pain population.Thus, new~     strategies for earlier recognition of analgesic responses for pain medications is fundamental~     in the field of dentistry. Therefore, this study will evaluate the clinical utility of~     pharmacogenomic testing in acute postoperative dental pain management among healthy adults~     who undergo extraction of impacted mandibular third molar.~   "
48467|NCT02932540|"~     Cerebral autoregulation is an important mechanism whereby cerebral perfusion is normally~     maintained at a constant level, over a relatively wide blood pressure range. It can be~     assessed noninvasively by the use of Trans Cranial Doppler (TCD). This means using ultrasound~     probes over both sides of the head to measure changes in blood flow in one of the main brain~     arteries (the middle cerebral artery) in response to beat to beat changes in blood pressure~     dynamic cerebral autoregulation (dCA). It is established that dCA is impaired following~     moderate to severe stroke, acting as a key role in the development of secondary brain damage~     related to brain swelling and further damage related to the low blood flow. The~     administration of clot busting therapy (thrombolysis), one of the main approved treatments of~     acute ischaemic stroke (AIS), results in recanalisation of the blocked artery in only~     approximately 50% of patients. Therefore, as well as attempts to treat major vessel blockage,~     improving brain blood flow, particularly to the penumbral area, through arteries that bypass~     the blockage is another potential therapeutic approach in AIS.One simple way of achieving~     this might be to lower the head of AIS patient into a lying flat (0⁰) position. However, to~     date, there have been very few studies exploring this. This research will use the noninvasive~     technique of Trans Cranial Doppler (TCD) to see how blood flow changes in different head~     positions, both in healthy volunteers and AIS patient. This study will provide important data~     regarding blood pressure management in acute stroke, an important and common clinical~     dilemma.~   "
48468|NCT02932527|"~     Lifestyle and environmental factors can disrupt development and testicular function. In~     France, cannabis is the most widely used illicit substance and about 8% of adults between 18~     and 64 years smoke cannabis at least once a year, and mostly men under 45 years.~     Endocannabinoids are lipid mediators that share some effects with the active ingredients of~     cannabis. Cannabis and endocannabinoids act via two types of endogenous receptors which were~     detected at different levels of the reproductive system and are involved in the central and~     local regulation of the gonad. Cannabis use may alter the normal regulation of the~     endocannabinoid system. In males, the regulation of the endocannabinoid system is critical~     for Sertoli and Leydig cells functions, germ cell differentiation, maturation of sperm~     nucleus and sperm quality. The cannabis can have a negative impact on sperm parameters,~     capacitation and acrosome reaction. Cannabinoids may decrease testosterone synthesis and~     induce apoptosis of Sertoli cells. Studies on the effect of cannabinoids on male fertility~     are scarce or nonexistent in infertile men because of ethical considerations and bias due to~     consumption often underreported. Investigators hypothesized that cannabis use may alter sperm~     nuclear quality. Investigators want to explore this hypothesis conducting a multicentric~     prospective study exposed/non-exposed in infertile men who are consulting for Medically~     Assisted Reproductive Technologies (ART). To reach this study, it is planned to include a~     total of 200 subjects taking into account any exclusions.~   "
48469|NCT02932514|"~     The purpose of this clinical investigation is to evaluate the accuracy of the Eversense~     Continuous Glucose Monitoring System (Eversense System) measurements when compared with a~     Self-monitoring blood glucose (SMBG) meter. The investigation will assess device performance~     in two insertion locations (abdomen and upper arm), evaluate safety of the Eversense System~     usage, and assess the usability of the Eversense system in the hands of user at home setting.~     Changes in HbA1c from baseline will also be evaluated.~   "
48470|NCT02932501|"~     Approximately 500 patients will be included in this patient registry. Data collection~     includes demographics, clinical data of underlying disease and use of bisphosphonates,~     denosumab and antiangiogenic drugs , degree and extension of osteonecrosis,~     osteonecrosis-specific treatment, outcomes and complications within 1 year after treatment.~   "
48471|NCT02932488|"~     The purpose of this study is to show that PET-MR imaging can be used for obtaining a~     pharmacodynamic profile of drugs. By using the 5-HT1B receptor as target we also aim to find~     effect areas and sizes of the 5-HT1B receptor agonist sumatriptan.~   "
48472|NCT02932475|"~     Purpose: The objective of this proposal is to study the safety and efficacy of metformin~     added to insulin for treatment of type 2 diabetes mellitus (T2DM) among pregnant women.~      Participants: 1200 pregnant women with type 2 diabetes complicating pregnancy from 10 U.S.~     clinical centers~      Procedures (methods): Pregnant women with T2DM between 10 weeks and 20 weeks 6 days and a~     singleton fetus will be randomized to insulin/placebo versus insulin/metformin. Primary~     outcome is composite adverse neonatal outcome (clinically relevant hypoglycemia, birth~     trauma, hyperbilirubinemia, stillbirth/neonatal death). Study visits monthly at clinical~     visits; blood draw at 24-30 weeks. Maternal and infant outcomes will be chart abstracted.~   "
48473|NCT02932462|"~     A Randomized Double-Blind, Vehicle-Controlled, Parallel Design, Multiple-Site, Phase III~     Clinical Study~   "
48474|NCT02932449|"~     This is a 5-year, longitudinal, observational study of patients with PBC designed to~     specifically address important clinical questions that remain incompletely answered from~     registration trials. In addition to the study database, a bio specimen repository will also~     be included so that translational studies of genomics and biomarkers of response may be~     performed.~   "
48475|NCT02932436|"~     The purpose of the EmDia trial is to compare the effects of empagliflozin with placebo in~     addition to standard diabetic treatment or dietetic treatment on cardiac diastolic function~     in patients with type 2 Diabetes mellitus.~   "
48476|NCT02932423|"~     The purpose of this clinical study is to investigate the effect of drinking a sugar-sweetened~     beverage along with a meal on insulin concentrations and, glucose and lipid metabolism, in~     overweight and obese subjects, during a 10-hour visit.~   "
48477|NCT02932410|"~     This is a prospective, multicenter, open-label, randomized, controlled, parallel group,~     group-sequential, event-driven Phase 3 study to evaluate efficacy, safety and~     pharmacokinetics (PK) of macitentan in children.~   "
48543|NCT02931552|"~     The primary aim is to assess the effectiveness of the Nuevo Amanecer-II (NA-II)~     cognitive-behavioral stress management program through a 6-month RCT with 150~     Spanish-speaking Latinas with breast cancer in three rural settings in terms of improving~     quality of life (QoL) and reducing distress, compared to a usual care control group (that is~     offered the program at the end of the 6 months). The investigators will also test the effects~     of the program on biomarkers of stress (hair and saliva cortisol) and aging (telomere length~     from saliva). Trained Latinas, called Compañeras (Companions), who have had breast cancer~     deliver the stress management program in-person to Spanish-speaking Latinas with breast~     cancer.~   "
48478|NCT02932397|"~     Emergence of general anesthesia is a critical period, in the same way as the induction of~     anesthesia, during which several adverse events may occur. Extubation may even be more~     difficult than the intubation, with a higher respiratory complications rate. Among these,~     cough is common and expected. It can be associated with significant complications including~     hypertension, tachycardia, increased intracranial pressure, bleeding at the surgical site or~     even wound dehiscence.~      The incidence of coughing during emergence of general anesthesia varies depending on the type~     of airway instrumentation, the population under study, agents used for the maintenance of the~     anesthesia and techniques used to prevent coughing. In the literature, the incidence of~     coughing during emergence of general anesthesia under endotracheal intubation varies from 38~     to 96%. In our center, the incidence of coughing during emergence of general anesthesia under~     desflurane and endotracheal intubation is 30 % according to a local preliminary study.~      Propofol is well-known to inhibit airway reflexes. Total intravenous anesthesia (TIVA) is~     associated with a lower incidence of coughing compared to inhalated anesthesia. The efficacy~     of propofol at a subhypnotic dose to reduce coughing during emergence has recently been~     demonstrated in patients undergoing nasal surgery under sevoflurane. However, the most~     effective antitussive dose remains unknown and its efficacy during anesthesia under~     desflurane has not yet been demonstrated.~      Propofol is rapidly available, simple to administer and has an interesting pharmacological~     profile, among others due to its short half-life.~      The aim of this study is to evaluate if an intravenous bolus of 0.5 mg/kg of propofol is more~     effective than placebo administration to decrease the incidence of coughing during emergence~     of general anesthesia under desflurane (PROPOREV). Propofol could also reduce the incidence~     of postoperative nausea and vomiting (PONV).~   "
48479|NCT02932384|"~     The proposed research study will focus on Black men who have sex with men (BMSM) who~        -  are HIV- or unknown status AND~        -  have not received HIV testing in over a year or~        -  who test irregularly (on 9/21/2016, the protocol was changed to modify the last to~          criteria and focus on those who have not used PrEP in the prior six months).~      and implement an innovative, culturally-informed, peer-based, and client-centered approach~     that is designed to increase their awareness of their HIV status and their timely entry into~     prevention (including PrEP), testing, care, and treatment services. The research design~     compares the effect of an incentives-only approach to one that uses incentives, along with~     the involvement of peer mentors to support timely entry into prevention, testing, care and~     treatment. This phase of the study is designed to assess peer-supported intervention group~     versus a passport/incentive-only control group over an 18-month period using a randomized~     trial approach.~   "
48480|NCT02932371|"~     The objective of the study is to estimate the reliability of the determination of the cardiac~     output measured by the ECOM™ device. This study will be performed with the latest version of~     the software which should give better results than those published previously. Two techniques~     of measure of the cardiac output will be compared: the reference measure by trans-esophageal~     echography and the bioimpedance used by the ECOM™. monitor.~   "
48481|NCT02932358|"~     A cluster-randomized crossover trial involving adult ICU patients, family members, and ICU~     professionals will be conducted. Forty medical-surgical Brazilian ICUs with visiting hours~     <4.5 h/day will be randomly assigned to either a restrictive family visitation model (RFVM)~     (visits according to local policies) or a flexible family visitation model (FFVM) (visitation~     during 12 consecutive hours per day) at a 1:1 ratio. After enrollment and follow-up of 25~     patients, each ICU will be switched over to the other visitation model, until 25 more~     patients per site are enrolled and followed. The primary outcome will be the cumulative~     incidence of delirium among ICU patients, measured twice a day using the Confusion Assessment~     Method for the ICU. Secondary outcome measures will include delirium-free days,~     ventilator-free days, any ICU-acquired infections, ICU length of stay, and all-cause hospital~     mortality among the patients; symptoms of anxiety and depression and satisfaction among the~     family members; and prevalence of symptoms of burnout among the ICU professionals. Tertiary~     outcomes will include need for antipsychotic agents and/or mechanical restraints, unplanned~     loss of invasive devices, and ICU-acquired pneumonia, urinary tract infection, or bloodstream~     infection among the patients; self-perception of involvement in patient care among the family~     members; and satisfaction among the ICU professionals.~   "
48482|NCT02932345|"~     The primary objective is to describe the genomic profile of long-term survivors, especially~     to find out potential genomic prognosis and/or predictive factors for gefitinib long-term~     efficacy as compared to rapid PD patients~   "
48483|NCT02932332|"~     The goal of this clinical research study is to compare high-flow oxygen, low-flow oxygen,~     high-flow air, and low-flow air in helping to decrease shortness of breath in cancer~     patients. Researchers also want to learn if these therapies can help to improve lung function~     and quality of life.~   "
48484|NCT02932319|"~     15 to 20 % of nulliparous needs an induction at term. None study has evaluated Foley catheter~     induction at home versus expectative in this population~   "
48485|NCT02932306|"~     Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris~   "
48486|NCT02932293|"~     There is only one kind of treatment (simeprevir 150 mg + sofosbuvir 400 mg+daclatasvir 60 mg)~     in this study but the treatment duration may be different depending on patients' response to~     the antiviral therapy and whether patients have liver cirrhosis. If patients have no~     cirrhosis and the HCV viral load on day 2 is <500 IU/ml, patients will receive sofosbuvir,~     daclatasvir and simeprevir for 3 weeks, otherwise the treatment duration is 4 weeks. If~     patients have cirrhosis and the HCV viral load on day 2 is <500 IU/ml, patients will receive~     sofosbuvir, daclatasvir and simeprevir for 6 weeks, otherwise the treatment duration will be~     8 weeks.~   "
48487|NCT02932280|"~     The purpose of this study is to test the safety of neratinib at different dose levels and to~     find out what effects, good and bad, it has on the patients and the cancer.~   "
48488|NCT02932267|"~     This is a multicenter open-label, prospective study in subjects with dark skin from one of~     the 3 ethnic/race backgrounds: Asian, Latin American and Black/African-American and with~     moderate to severe acne vulgaris on the face.~      All eligible subjects will receive Adapalene 0.3% - BPO 2.5% gel (Epiduo Forte/TactuPump~     Forte) once daily on whole face.~      The purpose of this trial is to evaluate subject reported outcomes with the combination of~     Adapalene 0.3% - BPO 2.5%, Epiduo Forte / TactuPump Forte gel, after 16 weeks of treatment of~     moderate to severe acne in dark skin phototypes (IV to VI).~   "
48489|NCT02932254|"~     The aim of this study is to evaluate the treatment effect of magnesium sulfate on the T4 / T1~     ratio after reversal with sugammadex deep or moderate neuromuscular blockade induced by~     rocuronium.~   "
48544|NCT02931539|"~     The purpose of this study is to determine if an investigational treatment (Maribavir) is safe~     and effective in treating transplant recipient subjects with cytomegalovirus (CMV) infections~     that are refractory or resistant to treatment with ganciclovir, valganciclovir, foscarnet, or~     cidofovir.~   "
48490|NCT02932241|"~     Alcohol use is considered to be a significant risk factor among those who die by suicide,~     especially among those who drink to regulate their emotions. Unfortunately, there is a dearth~     of treatment outcome research for suicidal heavy drinkers. Further, treatments that target~     this population must be maximally effective, with promise for wide dissemination. The~     application of technology has been increasingly utilized as an efficacious and acceptable way~     to rapidly disseminate evidence-base treatment. However, these methods are used infrequently~     for individuals deemed too high risk for computerized treatment. Along these lines, the goal~     of this project is to begin a line of research focused on developing interventions to reduce~     heavy drinking and risk for suicide through the use of technology. Dialectical Behavior~     Therapy (DBT) skills training is an effective intervention for behaviors associated with~     emotion dysregulation including addictive and suicidal behaviors. Further, DBT skills use has~     been identified as the active ingredient for treatment effectiveness; thus, a skills training~     intervention delivered via the Internet has the capacity to be a potent and efficient method~     of treatment delivery. The goal of this research is to establish a proof of concept for~     developing and evaluating a potentially efficacious and acceptable intervention for heavy~     episodic drinkers who are suicidal. Specifically, this project proposes to conduct a~     randomized controlled pilot trial of a computerized DBT skills training intervention for~     suicidal individuals who engage in heavy episodic drinking (HED) to regulate emotions. The~     project's aims are to conduct a randomized controlled pilot trial of cDBT vs. a Wait-list~     control (WL). This pilot trial is not intended to demonstrate that cDBT works better than~     other interventions in improving clinical indices, but rather to determine whether further~     revisions of the cDBT intervention are needed and will inform the design of a subsequent~     full-scale randomized controlled trial.~   "
48491|NCT02932228|"~     This evaluation will examine the feasibility, implementation, and effectiveness of a quality~     improvement intervention-Intensive Management Patient Aligned Care Team (ImPACT)-for~     high-risk patients.~   "
48492|NCT02932215|"~     This is a 10 week, open-label, prospective study, involving 10 volunteer participants with~     cannabis use disorder to test the feasibility and safety of using lorcaserin in addition to~     the feasibility, likability, and utility of a mobile sensor device in cannabis users. The~     study will be entirely outpatient. Upon study entry, participants will begin clinic visits at~     the Substance Treatment and Research Service (STARS) clinic. All consented participants will~     receive a Fitbit Charge HR device in week 1 to wear for the entire study and receive~     lorcaserin beginning in week 2 for a total of 8 weeks (weeks 2-9). At the beginning of week~     10 following discontinuation of lorcaserin, the participants will continue to wear the Fitbit~     Charge HR device for this final week following completion of the medication trial. All~     participants will visit the clinic twice weekly to provide urine toxicology on THC, report on~     adverse events, complete additional assessments (outlined below), and upload de-identified~     data from the Fitbit Charge HR device to the secure encrypted Fitabase database. Study~     assessments will be collected at baseline, throughout the study, and 1 week following~     medication discontinuation. All participants will also receive medical management, a~     medication adherence focused psychosocial intervention that facilitates compliance with study~     medication and other study procedures, including adherence to wearing the Fitbit Charge HR~     device, and promotes abstinence from cannabis and other substances. Progressive voucher~     incentives will be provided for compliance with visit attendance and study procedures.~   "
48493|NCT02932202|"~     Obesity and excessive weight gain in pregnancy have significant associated maternal and fetal~     complications including gestational diabetes, large for gestational age infants, birth~     trauma, and stillbirth. The standard of care places the responsibility on the providers~     during prenatal visits to remind patients of their weight gain goals and provide appropriate~     counseling. The objective of this study is to evaluate a sustainable medical student-assisted~     longitudinal program of nutritional counseling and web based nutrition tracking for pregnant~     women on excessive weight gain during pregnancy and the effects on diet choices and fetal and~     maternal complications.~   "
48494|NCT02932189|"~     Introduction:~      It is well established that physical fitness improves muscle performance either in sedentary~     people or in athletes. In this regard, specific exercises for respiratory muscles can result~     in better functional performance in hospitalized individuals, especially in critically ill~     patients in prolonged weaning.~      Objectives:~      To compare the following variables between intervention and control patients: success in~     weaning, free time off ventilator on ICU after weaning, and gain of muscle strength with the~     use of the inspiratory muscle training (IMT).~      Patients and methods:~      Prospective randomized controlled clinical trial. Only individuals on prolonged weaning will~     be enrolled. They will undergo IMT or will be managed in a conventional manner. The primary~     endpoint will be successful weaning. In addition, other variables such as free time off~     ventilator on ICU after weaning and muscle strength will be measured. In addition, mortality~     in the ICU, inside the hospital and after discharge will be followed for one year after study~     entrance.~      Expected results:~      According to the working hypothesis, it is expected that the performance of patients~     undergoing IMT will be superior to the conventional treatment. Also, their time to mortality~     is expected to be longer.~   "
48495|NCT02932176|"~     The use of handheld arterial 'stethoscopes' (continuous wave Doppler devices) are ubiquitous~     in clinical practice. However, most users have received no formal training in their use or~     the interpretation of the returned data. This leads to delays in diagnosis and errors in~     diagnosis.~      The investigators intend to create a novel machine-learning algorithm to assist clinicians in~     the use of this data. This study will allow the investigators to collect sound files from the~     use of the devices and compare the algorithms output to established, existing vascular~     testing. There will be no invasive procedures, and use of these stethoscopes is part of~     routine clinical care.~      If successful, this data and algorithm will be later deployed via smartphone app for point of~     case testing in a separate study~   "
48496|NCT02932163|"~     Chronic non-specific low back pain (CNSLBP) has been defined as a persistent pain in the~     lower back for at least three months with no known causes. The CNSLBP prevalence is estimated~     of 90% among all types of the LBP. The LBP imposes high direct and indirect costs on the~     patients and the society. Whereas a specific pathology has not been identified for CNSLBP,~     mechanical factors (e.g. changes in muscle length, strength, or endurance) may contribute to~     the pain and disability.~   "
48545|NCT02931526|"~     The aim of this study is to determine the Pharmacokinetics/Pharmacodynamics(PK/PD) of~     tigecycline in critical ill patients undergoing continuous renal replacement therapy（CRRT）and~     examine whether the dosage needs adjustment.~      The study will observe two groups of patients respectively and compare the difference between~     them. Patients who need to receive CRRT when treat with high-dose tigecycline will be~     collected in Group CRRT. Patients who treat with high-dose tigecycline only will be collected~     in Group non-CRRT.~   "
48943|NCT02926313|"~     A randomized control study aimed to investigate if suitable individualized seating provision~     is effective for adult nursing home residents in reducing the incidence of pressure ulcers,~     and increasing their quality of life and functioning.~   "
48497|NCT02932150|"~     The primary objective of Cohort 1 of this study is to evaluate the safety, tolerability, and~     antiviral activity (HBV DNA < 20 IU/mL) of tenofovir alafenamide (TAF) 25 mg once daily~     versus placebo through Week 24 in treatment-naive and treatment-experienced adolescent~     adolescents (aged 12 to < 18 years) with chronic hepatitis B (CHB).~      Cohort 2 will consist of 2 parts: Part A and Part B. Intensive pharmacokinetic (PK) data will~     be collected from all participants in Part A to confirm the dose of TAF in each dose group~     and the remaining participants will be enrolled into Part B once dose confirmation is~     achieved. The primary objectives of Part A are to evaluate the steady-state PK of TAF and~     tenofovir (TFV) and confirm the dose of TAF given once daily in children (aged 2 to < 12~     years) with CHB. The primary objective of Part B is to evaluate the safety and tolerability~     of TAF at Week 48 and the antiviral activity (HBV DNA < 20 IU/mL) of TAF at Week 24 in~     children (aged 2 to < 12 years) with CHB.~   "
48498|NCT02932137|"~     The objective of this clinical study is to evaluate the potential effect of anti-infection of~     low-does IL-2 in patients with SLE.~   "
48499|NCT02932124|"~     The aim of this study was to analyse a large CPR database, the German Resuscitation Registry,~     to evaluate potential benefits of mechanical CPR devices over manual CPR in adult cardiac~     arrest victims. The primary endpoint considered is ROSC.~   "
48500|NCT02932111|"~     The Irritable Bowel Syndrome (IBS) is defined by a combination of abdominal pain, bowel~     dysfunction during recurrent periods of shorter or longer duration. The absence of~     well-defined pathophysiological marker requires a clinical definition. The most used are the~     Rome criteria III whose version was published in 2006 and version IV under development.~      An epidemiological study conducted in 2003 in Europe in 8 countries with over 42 000 people,~     found on the basis of questionnaires a prevalence of 11.5% with a diagnosis of IBS of 4.8%.in~     the total population; the results of this study were comparable to data obtained in the USA.~     A French work of our team at 35 447 healthy adults found a 6.2% frequency. In all these~     studies, there is a very large predominance of women (sex ratio near 2), with a preponderance~     of subjects of the age group 40-50 years.~      IBS economic weight is high, partly due to costs directly incurred by the IBS and the costs~     generated by associated diseases: number of visits to the general practitioner, to the~     specialist, the prescription and realization of complementary examinations, hospitalization,~     purchase drugs and work stoppage.~      From a pathophysiologic perspective, IBS is now considered as a multifactorial disease~     involving varying degrees, depending on the individual variables, visceral hypersensitivity,~     disturbances of digestive motility, impaired sensorimotor way communications between the~     gastrointestinal tract and the central nervous system, intestinal micro-inflammation.~      Hypothesis of this search is that the osteopathic manipulative treatment (OMT) will improve~     the symptomatology of IBS in patients with functional gastrointestinal disorders.~   "
48501|NCT02932098|"~     Purpose: The purpose of this study will be to test the use of a web-based mobile application~     (app) initiated at the time of hospital discharge to engage and monitor patients in order to~     efficiently deliver better outcomes. The mobile app will be used to remind patients of~     discharge instructions, assess adherence treatment regimens, and evaluate symptoms.~      Rationale: Approximately 60% of patients with ovarian cancer have advanced stage disease at~     diagnosis, and thus aggressive surgical procedures are often medically necessary. Recent~     evidence suggests that nearly one in five patients hospitalized for ovarian cancer surgery~     will be readmitted within 30 days of discharge. Patients readmitted within 30 days have a 50%~     increase in one-year mortality rates and significantly increased costs of care. In addition,~     many of the conditions and complications that led to readmission could potentially have been~     avoided with more intensive post-surgical follow-up care. Mobile health technologies can~     effectively and efficiently connect patients with their healthcare team and have been shown~     to improve treatment adherence and reduce avoidable ER visits and hospitalizations.~   "
48502|NCT02932085|"~     This study is a randomized, double-blind, and sham-controlled trial to examine the effects of~     transcranial magnetic stimulation on the brain of health individuals.~   "
48503|NCT02932072|"~     Microscopy remains a key indicator in drug efficacy testing performed in the context of~     clinical trials for monitoring existing antimalarials or in the context of regulatory~     clinical trials for registration of new drugs. It is one of the main diagnostic methods for~     malaria diagnosis in general, as in an ideal setting it can provide low-cost accurate~     diagnosis, determine the density of parasites in the blood, and accurately differentiate~     between different malaria parasite species, characteristics vital to the implementation of~     global plans for drug efficacy monitoring. Malaria rapid tests (RDTs), while useful for case~     management, do not provide information on the parasite density nor the species~     differentiation necessary for research and drug efficacy assessment. Microscopy therefore~     retains key advantages over a number of newer technologies, but its reliability is severely~     impeded by dependence on high technical competence of the human operators as well as~     availability of high quality equipment and reagents. Recent studies have demonstrated the~     frequent poor specificity and sensitivity associated with manual microscopy diagnostics in~     operational conditions , , . Advances in digital microscopy performance and affordability~     have now opened the door to potentially significant improvements in the performance of~     malaria diagnostic microscopy, overcoming serious deficiencies in current drug efficacy~     assessment, and more broadly in malaria diagnosis and management.~      Intellectual Ventures Laboratory (IVL), in collaboration with Global Good Fund (GG), has~     developed an initial microscope prototype to support its research into dark field imaging of~     unstained malaria slides. The system consists of low cost electromechanical components for~     scanning a standard slide, an optical train with a high numerical aperture objective, and an~     image capture system. Captured images are analyzed with custom image analysis software~     developed at GG/IVL, using algorithms that are designed for automatic malaria diagnosis,~     without user input. Additionally, image processing algorithms have been built around~     detection of Giemsa-stained malaria slides which is the current standard for malaria~     microscopy. Initial results show excellent potential for sensitivity and specificity which~     exceeds that of typical manual microscopists in the field. Based on the positive market and~     needs assessment in January, 2013, given by stakeholders in the malaria diagnostics~     community, GG/IVL are pursuing improvement and integration of this algorithm into a portable~     microscope platform with characteristics similar to the prototype microscope already~     developed at GG/IVL for dark field imaging. The prototype Autoscope was first tested in field~     settings in Thailand in Nov 2014 - Jan 2015 at clinics operated by the Shoklo Malaria~     Research Unit (SMRU). The goal of the first field evaluation was to assess the Autoscope in~     with respect to its diagnostic performance and also its suitability for harsh conditions~     typically encountered in field clinics. Further, user feedback on the design and~     functionality was sought. The Autoscope and the accompanying image analysis algorithms have~     since been further developed and a new version is now available for testing.~   "
48504|NCT02932059|"~     The purpose of this study is to determine the respective roles of aging and schizophrenia in~     the regulation of metamemory using a sentence construction strategy. 4 groups will be~     necessary to comparison:~      Adult patients (18-45 years) Adult controls (18-45 years) Aged patients (≥ 55 years) Aged~     controls (≥ 55 years)~      The effects of age and the disease could lead to interaction in regulating metamemory. The~     effect of age would be aggravated by the disease.~   "
48505|NCT02932046|"~     Anorexia means loss of appetite. But there is disagreement about whether the appetite is~     changed by the disease anorexia nervosa (AN). Appetite is a subjective essential sense, which~     is regulated in a complex ensemble between brain, stomach - intestinal system and hormones.~     As a direct result of malnutrition, there are many somatic complications caused by the~     disease AN. Several of these complications may in itself affect hunger- and satiety~     perception. An example of this is delayed gastric emptying. Furthermore, changes in the~     hormone systems affects the biological reward system in the brain, which plays an important~     role in appetite regulation. There is clearly need for research that could lead to better~     treatments for AN. Hunger- and satiety perception has only been studied in a few small~     cross-sectional studies with no clear conclusion.~      The purpose of the study is to determine whether a visual analog scale measurement can detect~     changes in hunger- and satiety perception in a least 30 patients admitted to nutrition for~     life-threatening severe anorexia nervosa. It may lead to the first step in the development of~     a simple and inexpensive instrument which may prove to be useful in measuring the impact of~     new and ongoing treatments of the disease.~   "
48506|NCT02932033|"~     This prospective randomized trial is performed to analyze the post-operative pain (acute and~     chronic) after endoscopic TEP repair after bilateral inguinal hernia repair.~   "
48507|NCT02932020|"~     In this pilot study, investigators will test the efficacy of AlloGen-LI, an allograft derived~     from amniotic fluid, injected into the epidural space at the level of spinal stenosis as an~     anti-inflammatory treatment to relieve back and leg pain symptoms in patients with spinal~     stenosis and/or disc herniation. The patients will be followed for 12 weeks. The effect of~     this treatment will be examined by patient reported changes in pain and disability utilizing~     validated outcome measures, and MRI imaging evaluating changes in contrast enhancement and T2~     signal related to that reflect inflammation and degeneration.~   "
48509|NCT02931994|"~     Removal and prevention of formation of dental plaque biofilms is one of the current hygiene~     regimen to prevent, reduce or even reverse the gingival and periodontal disease condition. In~     such endeavors of mechanical plaque removal, tooth-brushing and use of dental floss play an~     important role. Gomes et al have presented a modification in the use of knotted floss in~     wider embrasure areas. The modification in the dental floss has been done so as to increase~     the effective width of the floss. The purpose of this study is to compare the reduction of~     the clinical signs of plaque accumulation, gingival inflammation and gingival trauma in the~     area the knotted floss technique has been utilized versus the area where conventional~     flossing has been utilized in Type I gingival embrasures. Patients' acceptability of the~     knotted flossing technique will also be evaluated. This study is part of a larger study~     protocol involving different sample groups comparing the knotted floss technique with~     conventional dental flossing, use of interdental brushes and unitufted brushes in type II and~     type III embrasures as well.~   "
48510|NCT02931981|"~     Our study aims to evaluate the role of Dickkopf-4 as biomarkers in the treatment of~     gastrointestinal stromal tumor.~   "
48511|NCT02931968|"~     This study is designed to recall all patients who have received a full-arch monolithic~     zirconia implant supported fixed dental prosthesis in the University of North Carolina (UNC)~     School of Dentistry Graduate Prosthodontic and/or Dental Faculty Practice clinics between~     January 1, 2008 to September 1, 2015. The main purpose is to evaluate the biological and~     technical complications associated with this form of prosthetic treatment. Additionally~     patient centered outcomes will be evaluated.~   "
48512|NCT02931955|"~     Study Objective Allergies affect up to 20% of the population of developed countries and can~     cause substantial individual disease burden. For some allergies, immunotherapeutic regimens~     (hyposensitization) have been established, e.g. for insect venom allergies and pollen~     allergies. This project aims at identifying the T cell activation potential in vivo from~     resting T cells of patients undergoing immunotherapy (IT) via a systems biology approach. For~     the participants, it involves blood draws and stool collection as well as gathering some~     basic medical information. The participation takes one week for patients undergoing insect~     venom IT and three months for patients undergoing pollen IT.~      This study is a cooperation project between the Centre Hospitalier de Luxembourg (CHL), the~     Luxemburg Institute of Health (LIH), the University of Luxembourg and the Integrated Biobank~     of Luxemburg (IBBL).~   "
48513|NCT02931942|"~     Rationale: Recent studies showed that ascorbic acid (AA) stimulates proliferation and~     maturation of T lymphocytes and NK cells. Chemotherapy results in depletion of those cells~     and thereby an increased infection rate. A pilot study showed low levels of AA in the plasma~     of several patients after chemotherapy for hematological malignancies. AA suppletion could be~     beneficial to the recovery of the immune system in these patients. But before an intervention~     study can be undertaken, further understanding of changing over time of AA levels and the~     relationship with the immune status after chemotherapy is necessary.~      Objective: The aim of this pilot study is to evaluate the changing over time of AA levels in~     plasma and in leukocytes before and during chemotherapy treatment for several different~     groups of patients and compare that to healthy controls. In this way we want to identify the~     patients were further interventions could be useful and use the data in the development of an~     intervention study for power calculations and to identify the primary endpoint.~      Study design: observational study~      Study population: There will be 6 different groups of participants in the study: two groups~     of patients that receive clinical intensive chemotherapy (acute leukemia and high dose~     chemotherapy with autologous stem cell rescue), two groups of patients that receive~     relatively mild chemotherapy in outpatient setting (colon cancer and lung cancer) and two~     control groups. All participants will be adults and recruited at the MUMC+. In total there~     will be 150 participants.~      Main study parameters/endpoints: Influence of chemotherapy on AA levels in plasma and in~     leukocytes.~   "
48514|NCT02931929|"~     Tyrosine-kinase Inhibitors (TKI) resistance in gastrointestinal stromal tumours (GIST) is a~     common problem after prolonged treatment periods. The main objectives of this monocentric~     diagnostic Phase I/IIa study are safety and tolerability, pharmacokinetics and dosimetry of~     68Ga-NeoBomb1 in GIST patients. The rationale behind this study is to improve diagnostic~     accuracy in GIST via positron-emission tomography/computer tomography (PET-CT) with a focus~     on TKI-resistant subtypes. Better detection, classification and definition of lesion extent~     are expected from the use of 68Ga-NeoBOMB1.~   "
48515|NCT02931916|"~     The purpose of this study is to evaluate the reliability and validity of smart-phone based~     system in postural control ability assessment on subjects with chronic ankle instability.~   "
48516|NCT02931903|"~     The aim of this study is to assess the effect of the newly introduced (hybrid dental ceramic)~     superstructure materials, Vita Enamic versus IPS Emax on implant stability, patient~     satisfaction and crestal bone loss.~   "
48517|NCT02931890|"~     The CRITICS-II trial aims to identify the optimal preoperative regimen in resectable gastric~     cancer by comparing three investigational treatment arms: chemotherapy vs. chemotherapy and~     subsequent chemoradiotherapy vs. chemoradiotherapy. The rationale behind this trial design is~     based on the following concepts:~        -  Preoperative treatment is associated with better patient compliance than postoperative~          regimens~        -  Preoperative treatment increases the likelihood of disease downsizing/downstaging and~          radical R0 resections~        -  Preoperative paclitaxel/carboplatin-based concurrent chemoradiotherapy and DOC~          chemotherapy are effective, feasible and safe regimens~   "
48518|NCT02931877|"~     As the investigators know, postoperative cognitive dysfunction (POCD) is a fairly~     well-documented clinical phenomenon, which affect patients' short-term and long-term outcome.~     Most patients will receive general anesthesia and cardiopulmonary bypass (CPB) during cardiac~     valvular surgery. Inhalation sevoflurane based and propofol based anesthesia are most~     commonly used strategy for general anesthesia. At present, it was unknown that which one is~     better in providing cerebral protection effect for patients undergoing cardiac valvular~     surgery with CPB. The current study aimed to explore the possible difference.~   "
48619|NCT02930551|"~     Neuromas are frequent after trauma and surgery, including amputation and can be identified by~     high-resolution ultrasound. The role of neuromas as the cause of neuropathic pain is~     uncertain. The investigators therefore wish to explore if spontaneous and evoked pain will be~     relieved by injection of local anesthetics near painful neuromas in subjects with peripheral~     nerve injury.~   "
48519|NCT02931864|"~     Breast cancer is the most common cancer in women in Singapore. Breast cancer survivors~     usually experience side effects/symptoms after surgery and/or adjuvant chemotherapy and/or~     radiotherapy such as fatigue, lymphedema, problems with sleeping, peripheral neuropathy, and~     anxiety/depression. Currently, there is no study to include both symptom management and~     mindfulness training components for breast cancer survivors. And given breast cancer~     survivors have infrequent clinical follow-up, we aim to develop an e-Home based symptom~     management and mindfulness training programme for breast cancer survivors and to determine~     its effects on quality of life, symptom distress, psychosocial adjustment, psychological~     morbidity, and unplanned outpatient attendance or hospitalisation in breast cancer survivors.~     We employ a randomised clinical trial with four study arms (with 47 subjects in each arm)~     together with a process evaluation; group 1 (usual care), group 2 (experimental group: five~     weekly sessions of online symptom management + mindfulness training programme and usual~     care), group 3 (comparison group 1: five weekly sessions of online symptom management~     programme and usual care), and group 4 (comparison group 2: five weekly sessions of online~     mindfulness training programme and usual care). Subjects will complete questionnaires~     measures of 6-item Social Support Questionnaire, Breast Cancer Survivor Self-Efficacy Scale,~     the Quality of Life-Cancer Survivor Scale, Memorial Symptom Assessment Scale, Psychosocial~     Adjustment to Illness Scale, short version of the Fear of Recurrence Scale, Hospital and~     anxiety Depression Scale and Five Facet Mindfulness Questionnaire at baseline (printed~     questionnaires), at 8 weeks from baseline, at 12 weeks from baseline and at 24 weeks from~     baseline by an online system or printed questionnaires. Individualised semi-structured~     interview (15-25 mins) for experimental and comparison groups will be conducted at 24 weeks~     from baseline to understand the subjects' experiences of the study programme. Data will be~     analysed using SPSS version 24. Baseline demographic and clinical information of subjects in~     the experimental, comparison and control groups will be summarised using descriptive~     statistics, and will be compared using chi square tests and ANOVA/ANCOVA tests.~     Intention-to-treat approach will be used. Repeated measures analysis of variance will be used~     to examine the differences on outcome measures among the experimental, comparison and control~     groups across study time points. In addition, differences in changes in outcome measures~     among experimental, comparison groups and usual care groups will be tested using multilevel~     modelling techniques. A p-value smaller than 5% will be considered as statistically~     significant. Content analysis will be conducted to analyse the interviews data.~   "
48520|NCT02931851|"~     Relatives in intensive care units (ICU) are important partners in decision-making in the~     treatment of critically ill patients and provide a significant resource in the care and~     recovery of patients. Therefore, a professional, educational intervention targeting these~     caregivers may have fundamental benefits with little risk. As in other fields, information is~     searched in the internet, but this unselected information is often overwhelming and of little~     use in this context.~      Symptoms of anxiety, stress and depression are common in affected relatives. The majority of~     family members report some level of anxiety, depression and stress, sometimes even resulting~     in post-traumatic stress disorder (PTSD). Importantly, an association between lack of~     information and post-traumatic stress disorder PTSD has been reported. The large number of~     potentially affected families poses a particular challenge to healthcare and may cause~     substantial secondary costs to national economy.~   "
48521|NCT02931838|"~     A Study to evaluate efficacy and safety in subjects with moderate to severe Psoriasis treated~     with BMS-986165~   "
48522|NCT02931825|"~     Colorectal cancer is one the most frequent cancer in developed countries. In France, it rank~     third with 43000 new cases in 2015. French Health Authority recommended colonoscopy screening~     for people with a high risk for colorectal cancer. But this compliance with colonoscopy is~     low (20-40%), it is therefore necessary to develop new strategies to improve compliance.~      The purpose of this project is to to offer and evaluate the feasibility and the effectiveness~     of a specific surveillance system for high risk people for colorectal cancer~      The project will be divided into 2 phases:~      Objectives of the first phase:~        -  Identify high risk people for colorectal cancer in the department of Indre-et-Loire,~        -  Fill in as completely as possible their colonoscopic history in the past 5 years,~        -  Estimate the proportion of high risk people for colorectal cancer in the target~          population for colorectal cancer screening in Indre-et-Loire (Men and women aged from 50~          to 74 years).~      Objective of the second phase:~      Compare the performed colonoscopy rate of high risk people for colorectal cancer without~     notion of colonoscopy in the past 58 months following or not (control group) the sending of a~     letter reminding the importance of compliance with colonoscopy.~   "
48523|NCT02931812|"~     This study evaluates the influence of the taste sensitivity, of food preferences and of the~     reward system on the energetic balance before and after liver transplantation in cirrhotic~     patients and after kidney transplantation in renal failure patients~   "
48524|NCT02931799|"~     Patients with Inflammatory Bowel Disease (IBD) are frequently hospitalized, with an increased~     risk of repeat hospitalizations within the same calendar year. Given that hospital~     readmissions represent a significant burden to patients and the health care system, a~     standardised pathway for IBD patients discharged from the hospital can have a significant~     impact on reducing readmission rates, healthcare utilization and patient satisfaction. The~     primary aim of this study is to evaluate the effectiveness of an IBD post-discharge pathway,~     involving post-discharge nurse follow-up and electronic monitoring, in reducing IBD~     readmission rates.~   "
48525|NCT02931786|"~     Investigators researched the effect of two different types of drugs on core body temperature~     during magnetic resonance imaging. The hypothesis is in ketamine group, thermo disregulation~     is not as distinct as in propofol group, due to its positive effect on thermo regulation~   "
48526|NCT02931773|"~     The investigators are studying the initial autonomic alterations in participants recently~     diagnosed with DM2 and in those patients classified as Pre-Diabetes, mainly focused on the~     baroreceptor sensitivity and on the peripheral sympathetic innervation.~   "
48527|NCT02931760|"~     Aim: To compare patient satisfaction with intramuscular placement of a pacemaker pocket to~     subcutaneous placement.~      Patients will be randomized (approximately half i each group) to receive the pacemaker device~     either subcutaneously (current practise) or intramuscular)~   "
48528|NCT02931747|"~     The purpose of this study is to determine the effect of Bacopa Monnieri on working memory and~     cognitive processing in student.~   "
48529|NCT02931734|"~     The aim of this study is through a randomized clinical trial, double blind, splith-mouth,~     evaluate the various types of protocols and clinical efficacy in the reduction or even~     elimination of dentinal hypersensitivity by the agents Desensibilize KF - FGM Dental~     Products, Clinpro - 3M Company, Minnesota - USA, Photon Laser III - DMC, Brazil,~     Desensibilize KF and laser, Desensibilize KF and Clinpro, laser and Clinpro and the~     association of all products. Data will be collected, tabulated and submitted to statistical~     analysis.~   "
48530|NCT02931721|"~     Testes of men with non-obstructive azoospermia (NOA) are imaged using MRI to find potential~     differences depending on the outcome, ie. sperm recovery in consequent microdissection~     testicular sperm extraction (MD-TESE).~   "
48620|NCT02930538|"~     The proposed research will determine whether a 6-item screening questionnaire previously~     shown to correlate with moderate or severe OSA is useful for predicting postoperative~     outcomes in children undergoing surgery under general anesthesia.~   "
48531|NCT02931708|"~     Heart failure is an incapacity to provide adequate blood flow to the others organs, such as~     brain, liver and kidney. The patients presents weakness and fatigue of inspiratory muscles,~     mainly diaphragm muscle, that contributes to dyspnoea and limited physical capacity in this~     patients.~      Some methods are being studied to decrease the diaphragm weakness. The diaphragm functional~     eletrical stimulation is a new technique, which has been studied to improve the respiratory~     muscle strength. Then, the aim of this study is to assess the effects of diaphragm functional~     electrical stimulation (FES) on respiratory muscle strength and muscle architecture of~     patients with heart failure.~      For this the following assessments will be performed before and after stimulation:~     manovacuometry to verify the maximum inspiratory pressure and maximum expiratory pressure;~     and ultrasonography to assess muscle architecture.~      The subjects will be selected by the decompensation in heart failure, with the adequate~     elegibility criteria. This study have no control group, because this technique has been~     little researched and could be unethical with the patient who won't receive this treatment.~      The subjetcs of this research will receive the diaphragm functional electrical stimulation~     twice of day for consecutive five days or until the hospital discharge.~      Expected results at the end of the protocol with Diaphragm Functional Electrical Stimulation~     are: to improve respiratory muscle strength; to correlate with diaphragm muscle arquiteture.~   "
48532|NCT02931695|"~     QT interval prolongation, corrected for heart rate (QTc), either spontaneous or drug-induced,~     is associated with an increased risk of torsades de pointes and sudden death. Women are at~     higher risk of torsades de pointes, particularly during post-partum and the follicular phase.~      The aim of this study is to explore if QTc duration is prolonged during post-partum as~     compared to the 3rd trimester of pregnancy~   "
48533|NCT02931682|"~     With only limited prospective longitudinal data currently available on Creatine Transporter~     Deficiency (CTD), its natural history is at present incompletely understood. This~     international study is designed to provide additional insights into disease progression, to~     characterize how patients perform on clinical neurodevelopmental assessments, and to evaluate~     magnetic resonance spectroscopy (MRS) and event-related potentials (ERPs) in patients with~     CTD.~   "
48534|NCT02931669|"~     The perception of disability has changed throughout history, and today, people who previously~     did not have a way to communicate are able to express themselves through Augmentative and~     Alternative Communication (AAC). However, the potential of AAC is not being fully realised~     and devices are often abandoned. It is therefore essential to hear the voice of those who use~     it and those who interact with them on a daily basis, in order to find out what the meaning,~     value and purpose of AAC is for them. This will support SLTs in directing intervention and~     establishing priorities, as well as in advocating for funding and acknowledging the voice of~     AAC users. The study uses a qualitative descriptive approach, using thematic analysis to~     establish emerging themes from surveys completed by AAC users, family members, health~     professionals, teachers, and face to face interviews with children who use AAC.~   "
48535|NCT02931656|"~     Gestational diabetes mellitus (GDM) is increasing worldwide and has been associated with~     adverse perinatal outcomes and high risk for chronic disease both for the mother and for the~     child. Physical exercise is feasible to diabetic pregnant women and contributes to a better~     glycemic control and to decrease adverse perinatal outcomes. However there are no studies~     assessing the effects of aquatic physical exercise on GDM control.~   "
48536|NCT02931643|"~     This study aims to investigate the effect of mixed of herbs and spices on gene expression of~     pathways associated with glucose homeostasis, oxidative stress, inflammation and its~     interrelation with circulating miRNA, in the postprandial phase in healthy human subjects.~   "
48537|NCT02931630|"~     The prevalence of overweight and lifestyle related diseases such as cardiovascular disease~     (CVD) and type 2 diabetes (T2D) is increasing world wide. The metabolic syndrome (MeS) is a~     condition characterized by abdominal obesity, high blood lipids, high blood pressure and~     elevated blood sugar. MeS is associated with an increased risk of developing CVD and T2D.~     Dietary fibers and whey protein have independently shown beneficial effects on several of~     these risk factors in previous studies. Whey protein is furthermore seen to show positive~     effects on bone turnover.~      The purpose of this trial is to investigate whether an increased intake of dietary fibers and~     whey protein (separately or combined) over a period of 12 weeks will affect the risk markers~     of MeS and bone turnover in abdominally obese subjects.~      A total of 80 people with abdominal obesity will be included. The design is a randomized,~     double blinded, controlled dietary intervention trial. Subjects are assigned to one of four~     experimental groups. Each group are provided with test products containing either high or low~     whey protein and high or low dietary fibers to replace part of their regular diet. The~     subjects are instructed in how to incorporate the test products in their habitual diets in~     order to maintain weight stability.~      The primary outcome is postprandial lipaemia (PPL) - an independent risk factor of developing~     CVD. PPL is estimated by performing a standardized high fat meal test during which~     postprandial level of triglycerides is measured. The authors hypothesize that a diet of high~     content of whey protein and high dietary fiber during 12 weeks will induce a reduction in~     PPL.~   "
48538|NCT02931617|"~     Two forms of pre and postoperative physiotherapy are compared in three cohorts of patients~     undergoing cardio-thoracic surgery: Minor thoracic surgery (biopsy), major thoracic surgery~     (lobectomy etc, open or VATS) and cardiac surgery~   "
48539|NCT02931604|"~     The purpose of this study is to clinically evaluate sinus wash device prototypes in patients~     with sinusitis during Endoscopic Sinus Surgery (ESS) and in the hospital outpatient~   "
48540|NCT02931591|"~     This study is aimed to determine if Metformin treatment in children born small for~     gestational age (SGA) who are being treated with Growth Hormone (GH) for short stature~     improves the response to GH by producing greater concentrations of Insulin-like growth factor~     -1 (IGF-1) in the blood.~   "
48541|NCT02931578|"~     The purpose of this study is to determine the glycemic index of commonly consumed sweeteners.~   "
48542|NCT02931565|"~     The objectives of this study are as follows:~      In patients with primary Type I or II Achalasia, following a single 5-mg dose of IW-1701,~        -  To assess the safety and tolerability~        -  To determine the effects on measures of esophageal function by high-resolution impedance~          manometry (HRIM)~        -  To determine the pharmacokinetic (PK) parameters, Cmax, Tmax, and AUClast~   "
48546|NCT02931513|"~     Primary biliary cholangitis (PBC) is an autoimmune chronic liver disease, characterised by~     destruction of the small intrahepatic bile ducts. Ursodeoxycholic acid (UDCA) is the first~     line treatment for patients with PBC. However, up to 40% of patients respond inadequate to~     this treatment.~      sCD163 is a macrophage activation marker shedded into plasma by macrophages in the liver. sMR~     is a soluble mannose receptor. The investigators want to investigate whether sCD163 and sMR~     can predict response to treatment with UDCA in newly diagnosed patients with PBC.~   "
48547|NCT02931500|"~     To develop machine learning algorithms for the identification of future development of~     cardiovascular and metabolic disease~   "
48548|NCT02931487|"~     Selective biases in attention can be modified by a simple computerized technique: The~     Attention Bias Modification Task (ABM) pioneered by MacLeod et al. Cognitive biases may be~     one reason depression recurs, and altering these biases should reduce risk of recurrence.~     Recently, evidence has supported this hypothesis . The mechanisms by which ABM works are not~     well understood. More research is needed to explore how altering an implicit attentional bias~     can lead to changes in subjective mood. One possible explanation is that positive attentional~     biases are an important component of explicit methods of emotion regulation. The ability to~     effectively regulate one's emotions is a fundamental component of mental health and this~     ability is impaired in depression. It has also been shown that recovered depressed people~     spontaneously show a more dysfunctional pattern of emotion regulation as compared to never~     depressed controls. Supporting this, growing evidence implicates dysregulation of a~     medial/orbitofrontal circuit in mood disorders. This circuit includes the orbitofrontal~     cortex and anterior cingulate cortex, the ventral striatum, the ventral pallidum and medial~     thalamus. Components of this circuit are reciprocally connected with the amygdala, which is~     implicated in emotional processing in the healthy brain and dysregulated in depression.~     Negative emotion processing biases depend on both enhanced bottom-up responses to~     emotionally salient stimuli and reduces top-down cognitive control mechanisms, required to~     suppress responses to emotionally salient but task irrelevant information. Cognitive~     reappraisal and distancing are common strategies to down- or upregulate emotional responses.~     Reappraisal is an emotion regulation strategy that involves reinterpretation and changing the~     way one thinks about an event or stimulus with the goal of changing its affective impact.~     Distancing is a type of reappraisal that involves creating mental space between oneself and~     the emotional event in order to see things from a different, less self-focused perspective.~     It has been shown that distancing is a strategy that people can improve at over time compared~     to reinterpretation. The neural systems which support the explicit regulation of emotion have~     previously been characterized and include both lateral- and prefrontal cortex. This frontal~     activity is predicted to downregulate limbic circuitry involving the amygdala during passive~     viewing of emotional salient stimuli.~   "
48549|NCT02931474|"~     Background:~      People who have had a traumatic brain injury (TBI) often have trouble sleeping. TBI may also~     alter hormones, which can cause poor sleep. Researchers believe that a form of growth hormone~     releasing hormone (GHRH) might improve sleep in service members and veterans who have had a~     TBI.~      Objective:~      To see if GHRH can improve sleep in people who have had a TBI.~      Eligibility:~      Active duty service members or veterans (active duty in the past 10 years) ages 18-45 who~     have had a TBI in the past 6 months to 10 years.~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Blood and urine tests~      Getting ACTH (a hormone) through an intravenous catheter (thin plastic tube)~      Interview about their mood and alcohol and drug use~      Questionnaires about their TBI, mood, and sleep~      Participants will have 2 overnight study visits a couple weeks apart. These will include:~      Physical exam~      Urine sample~      Two intravenous catheters placed. Blood samples will be taken throughout the night.~      Two shots under the skin of the belly. The shots will be GHRH on one visit and placebo on the~     other.~      Spending the night in the sleep lab. Their brain waves will be recorded with electrodes~     placed on the scalp.~      A questionnaire in the morning about their sleep~      Participants will be called a few days after each overnight visit. They will be asked about~     how they are feeling and to rate their sleep....~   "
48550|NCT02931461|"~     The ProCore ultrasound biopsy needle, used primarily to obtain intra-abdominal tissue core~     biopsies, has not been widely used for endobronchial ultrasound-guided transbronchial needle~     aspiration (EBUS-TBNA). In this study the investigators are going to evaluate the utility of~     the ProCore needle for sampling mediastinal or hilar lymph nodes during EBUS-TBNA versus~     standard 22 gauge needle for diagnosis of lung cancer.~   "
48551|NCT02931448|"~     In France, the carbon monoxide is one of the first causes of the accidental poisonings with~     approximately 8000 cases a year, among which 500 deaths.~      The severe forms are translated by neurological disorders even a coma or the death straight~     away. The more insidious forms with a little carboxyhémoglobine level give rise to frustrate~     clinical pictures, mimicking flu or intestinal syndromes. The syndrome post--intervallaire~     corresponds to the appearance of remote neuropsychiatric disorders of the poisoning. Its~     appearance and its gravity are not correlated in the gravity of the initial poisoning,~     however the precocity of the treatment tends to decrease its frequency.~      Carbon monoxide elimination is made under unchanged form in the expired air. In a spontaneous~     way, the half-life in ambient air is of the order of 4 hours. In ventilation in isobaric pure~     oxygen, the half-life is shortened at 80 minutes and in hyperbaric oxygen at 23 minutes.~      This imposes a fast diagnosis for two reasons:~        -  For poisonings with low level, the more the investigators wait to measure the~          carboxyhémoglobine (HBCO), the more they risk not to detect it.~        -  The oxygen therapy decreases the duration of the poisoning and thus the tissular~          suffering.~      Actually the risk is important to pass next to the diagnosis and to let leave a patient~     without adapted care and without technical intervention to eliminate the source of the~     poisoning.~      Presently, to make the diagnosis, the investigators possess the analysis of the blood HbCO by~     realization of gas of the venous blood, which are taken in emergencies, but very often a few~     hours after the end of the exposure at the source of poisoning, what is translated by a~     disappearance of the symptoms and an underestimate of the initial blood HbCO. Since 2005,~     MASIMO laboratory commercialize a pulse carboxymètre, the RAD 57, which allows to estimate~     the carboxyhémoglobinémie in a not invasive way.~      Lot of studies showed the interest of its use in the early screening of carbon monoxide~     poisonings, allowing a faster dosage of the blood HbCO, and thus an also faster adapted care.~   "
48552|NCT02931435|"~     Chronic knee osteoarthritis (OA) is one of the most common diseases with increasing~     prevalence in advanced age. Knee OA results in movement restriction, sleep disturbance, and~     disability. Total knee arthroplasty (TKA) is employed often in the symptomatic treatment of~     knee OA. It has been estimated that 3.4 million TKAs will be performed in the year 2030 in~     the United States alone. Many studies report rewarding outcomes for patients, but other~     research shows there are many patients that remain dissatisfied post-arthroplasty.~      The purpose of this study is to evaluate whether genicular radiofrequency ablation can~     relieve chronic post-arthroplasty knee pain.~   "
48553|NCT02931422|"~     The aim of the pilot study is to evaluate the feasibility, acceptability and costs of a~     financial incentive intervention to motivate pediatric HIV testing in Western Kenya. The~     study will evaluate 3 cash incentive values and determine percent uptake of testing. A~     post-test questionnaire will explore parental satisfaction, mechanisms of incentive~     effectiveness and the impact of testing on emotional health and pediatric healthcare~     utilization.~   "
48590|NCT02930941|"~     It is estimated that epistaxis results in 4.5 million emergency department visits per year~     throughout the United States. Due to the adverse effects of standard treatment options for~     epistaxis, tranexamic acid (TXA) may be considered an attractive option. In previous studies,~     when used with nasal packing, TXA showed faster time to control of bleeding. The goal of this~     study is to determine the efficacy and safety of topical intranasal TXA applied via atomizer~     for patients with epistaxis who present to the emergency department.~   "
48554|NCT02931409|"~     The purpose of this prospective randomized controlled trial is to determine the effects of~     intraoperative lung protective mechanical ventilation using an individual optimal PEEP value~     on postoperative pulmonary complications and inflammatory response. A total number of 40~     patients undergoing open radical cystectomy and urinary diversion will be enrolled and~     randomized into two groups. Standard lung protective ventilation using a PEEP of 6 cmH2O will~     be performed in control group and an optimal PEEP value determined during a static pulmonary~     compliance (Cstat) directed PEEP titration procedure will be applyed in study group. Low~     tidal volumes (6mL/Kg IBW) and a fraction of inspired oxygen (FiO2) of 0.5 will be applyed in~     both groups. Procalcitonin kinetics will be monitored during and after surgery until the~     third postoperative day as well as postoperative pulmonary complications. Clinical condition~     and extrapulmonary complications will be evaluated by the Sequential Organ Failure Assessment~     (SOFA) Score and in-hospital stay, 28-days and in-hospital mortality will also be followed.~   "
48555|NCT02931396|"~     The purpose of this study is to demonstrate the efficacy of FES for trans-tibial amputees.~     The investigators aim to demonstrate that providing three months of FES intervention will~     increase knee extension strength, increase volume of the residual limb and decrease chronic~     and phantom pain.~   "
48556|NCT02931383|"~     This is a substudy to a randomised trial investigating the effect of liraglutide on body~     weight and pain in overweight or obese patients with knee osteoarthritis (OA) (NCT02905864).~     In the parent trial, patients will be subjected to an 8-week diet intervention phase~     including a low-calorie diet and dietetic counseling, after which patients will be randomised~     to receive either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic~     guidance on re-introducing regular foods and a focus on continued motivation to engage in a~     healthy lifestyle.~      This substudy aims to investigate the impact of, and subsequent change of, joint inflammation~     and clinical symptoms, in obese patients with knee osteoarthritis following a randomisation~     to Liraglutide 3 mg or Liraglutide 3 mg placebo treatment between weeks 0-52.~   "
48557|NCT02931370|"~     This is a substudy to a randomised trial investigating the effect of liraglutide on body~     weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864). In~     the parent trial, patients will be subjected to an 8-week diet intervention phase including a~     low-calorie diet and dietetic counseling, after which patients will be randomised to receive~     either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on~     re-introducing regular foods and a focus on continued motivation to engage in a healthy~     lifestyle.~      This substudy aims to investigate any changes in Ultrasound (US) measures associated with the~     initial 8-week weight loss intervention.~   "
48558|NCT02931357|"~     This is a randomized, open label, parallel-groups, multicenter study. The study will be~     conducted in three clinical sites. Test Medical Device: 0.54% Hyaluronic Acid rose honey~     flavour gel medical device class IIa.~   "
48559|NCT02931344|"~     This is a substudy to a randomised trial investigating the effect of liraglutide on body~     weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864).~      This substudy aims to investigate any changes in biomarkers associated with the initial~     8-week weight loss intervention~   "
48560|NCT02931331|"~     Regional absolute myocardial blood flow during stress (sMBF) as measured by Positron Emission~     Tomography (PET) improves post mechanical revascularization provided there is a baseline~     stress induced perfusion defect. Coronary revascularization performed on regions without a~     stress induced perfusion defect does not increase the sMBF.~   "
48561|NCT02931318|"~     In this descriptive study, the purpose was to determine the knowledge levels and attitudes of~     the people in Nevsehir, Turkey on organ donation.~      It has been determined that the people living in Nevsehir do not have sufficient knowledge on~     organ donation, they had various concerns on the issue, and they wanted to receive~     information from Organ Donation Units. It can be used the exemplification and internalization~     in educational curricula about increasing the organ donation.~   "
48562|NCT02931305|"~     The primary objective of the trial is to develop Epimedium Prenylflavonoid (EP) extract as a~     pharmaceutical-quality intervention for post-menopausal osteoporosis and cardiovascular~     disease. There will be 3 cohorts of 10 healthy men each for the Phase 1 study. In each~     cohort, 8 men will receive the Epimedium capsules and 2 men will received the matched~     controls.~   "
48563|NCT02931292|"~     Obesity is a chronic disease and its treatment requires close follow-up to accurately assess~     the efficacy and durability of any treatment strategy. It is widely accepted that bariatric~     surgery patients require lifetime follow-up to assess for weight loss, co-morbidity changes,~     and nutritional deficiencies.~      The study objective was to ascertain efficacy of weight loss and complication rates in 562~     consecutive cases of laparoscopic sleeve gastrectomy (LSG) in a single surgeon practice.~   "
48564|NCT02931279|"~     Prospective, multicenter non comparative and observational study (post-market clinical~     follow-up).~      Patients operated with PASS OCT® manufactured by MEDICREA® INTERNATIONAL between July 2016~     and July 2017.~      The inclusion period will be 12 months and the follow-up 24 months~   "
48565|NCT02931266|"~     Prospective, multicenter non comparative and observational study (post-market clinical~     follow-up).~   "
48566|NCT02931253|"~     The purpose of this study is to see if the study drug metformin will help patients who are~     overweight and have atrial fibrillation. This study aims to see if metformin helps patients~     stay in normal sinus rhythm after a catheter ablation.~      Metformin is investigational for use in patients with atrial fibrillation. Metformin is~     approved by the Food and Drug Administration (FDA) for use in patients with type 2 Diabetes~     Mellitus. Metformin is used with a proper diet and exercise program to control high blood~     sugar, and has been shown to help people lose weight. This study aims to look at the effects~     of metformin on weight loss and heart rhythm in patients with atrial fibrillation.~   "
48567|NCT02931240|"~     A prospective, multi-center, dual-arm pivotal study of the BioVentrix Revivent TC System,~     with 2:1 study vs. active concurrent control group allocation ratio. This study will include~     126 patients of which 84 patients will be treated with the investigational device and 42~     patients will be included in an active control group.~   "
48675|NCT02929823|"~     The purpose of this study is to determine whether SJP-0035 ophthalmic solution is effective~     in promoting corneal epithelial wound healing in conditions associated with corneal~     epithelial disorders.~   "
48568|NCT02931227|"~     Temperature is one of the vital signs usually monitored in patients of ICUs. Indeed, fever~     occurs frequently in ICU especially in brain injured patients and may require targeted~     temperature management (TTM) in special case as intracranial hypertension or post cardiac~     arrest. In ICU, non invasive device to monitor temperature are not recommended and only~     invasive ones are accurate enough for TTM. Arterial pulmonary temperature is still the gold~     standard, but esophageal device is currently used in ICU patients.~      The goal of this study is to compare accuracy of a continuous noninvasive cutaneous~     temperature using zero-heat-flux (ZHF) method to esophageal temperature, arterial temperature~     and intracerebral temperature if present for clinical monitoring.~      All adults patients admitted in the neurosurgical or surgical ICU are eligible for inclusion~     into this study.~      Assessment of temperature will be continuously monitored by esophageal probe (MON-A-THERM,~     12Fr, COVIDIEN, Dublin, Ireland) (Teso), ZHF sensor (SpotOn, 3M, St Paul, MN, USA) (TZHF)~     and, in patients requiring cardiac output monitoring, by femoral arterial catheter~     (Pulsiocath PICCO, PULSION, Munich, Germany) (Tart). The correct positioning of the~     esophageal probe will be controlled by chest X-ray. The ZHF temperature sensor (TZHF) will be~     placed on the forehead as recommend by the manufacturer and connected to the SpotOn monitor.~     Intra cerebral temperature (Tbrain) will be obtained with an intracranial probe used as~     calibrator for partial pressure of O2 in brain (PbO2, Licox®Combined Oxygen and Temperature~     Probe 462 mm device necessary for monitoring severe brain injured patients. The ZHF sensor~     will be changed every 24 hours according to the manufacturer's directions for use.~     Temperatures will be recorded automatically at a 5-minutes interval via the patient's monitor~     with an electronic data acquisition system (Data Collect, Phillips) for a maximum of 5 days.~      For each patient included, data recorded will be: demographic and clinical particulars for~     each patient; information on hemodynamics, sedative, analgesic and inotropic agents, use of~     neuromuscular blockades and their indication, reason of hypo or hyperthermia (spontaneous or~     therapeutic), indication and the means used (neuromuscular blockades, external or internal~     cooling) in case of Targeted Temperature Management; complications related to the ZHF sensor~     application.~   "
48569|NCT02931214|"~     The purpose of this study is to evaluate safety and pharmacokinetics of single ascending IV~     doses of GMI-1359 in healthy adult subjects.~   "
48570|NCT02931201|"~     The purpose of this study is to evaluate whether a semi-quantitative interpretation using the~     liver SUVmax as reference can better interpret 18F-FDG PET/CT and predict disease progression~     during chemotherapy or survival in DLBCL.~   "
48571|NCT02931188|"~     There are currently no studies evaluating the effect of anacetrapib on blood vessel function~     and stiffness of the arteries. The REVEAL-Vasc trial will assess whether anacetrapib, in~     addition to atorvastatin (LDL-C lowering drug) treatment, results in greater~     endothelial-dependent vascular function and aortic stiffness in patients with established~     cardiovascular disease, compared to adding placebo.~      Participants will be asked to provide a blood sample and pulse Wave Velocity/Pulse Wave~     Analysis and Flow Mediated Dilation will be carried out to assess blood vessel function and~     stiffness of the arteries. REVEAL-Vasc is an investigator led sub-study of HPS3/TIMI 55:~     REVEAL (Randomized Evaluation of the Effects of Anacetrapib through Lipid modification): A~     large-scale, randomized placebo-controlled trial of the clinical effects of anacetrapib among~     people with established vascular disease (NCT01252953) which is coordinated by OXFORD CTSU.~      No treatment will be received on this sub-study, therefore only participants who have been~     enrolled in HPS3/TIMI55 REVEAL in which participants received anacetrapib with atorvastatin~     or placebo will be considered for this trial.~   "
48572|NCT02931175|"~     The study aims to evaluate the potential role of ACTH gel in the management of non-infectious~     uveitis.~   "
48573|NCT02931162|"~     To investigate the mechanism and effects of moxibustion on patients with ulcerative colitis.~   "
48574|NCT02931149|"~     To avoid complications secondary to advanced endoscopic resection techniques (Endoscopic~     Mucosal Resection -EMR- or Endoscopic Submucosal Disection -ESD-) the endoscopists have to~     avoid deep thermal damage and increase mucosal healing. Platelet-rich plasma (PRP) has~     demonstrated efficacy in preclinical endoscopic resection models.~   "
48575|NCT02931136|"~     The purpose of this study is based on the Flutemetamol-PET senile plaque imaging to~     investigate the peripheral blood biochemical and brain MRI imaging biomarkers and to research~     completely independent intellectual property rights neuropsychological test tool for the MCI~     due to AD. At the same time, the investigators will study the efficacy and safety of early~     treatment of MCI due to AD by Huperzine A in 52 weeks.~   "
48576|NCT02931123|"~     This is a randomized controlled trial whose purpose is to evaluate the efficacy of therapy~     with lactulose and rifaximin associated with a vegetable diet in the prevention of post-TIPS~     hepatic encephalopathy.~   "
48577|NCT02931110|"~     This clinical trial is a Phase 1, open-label, sequential-group, dose-escalation (Part 1) and~     cohort-expansion study (Part 2) evaluating the safety, pharmacokinetics, pharmacodynamics,~     and antitumor activity of CBL0137. The study will evaluate CBL0137 administered IV weekly on~     Days 1 and 8 of repeated 21 day treatment cycles in subjects with previously treated~     hematological malignancies.~   "
48578|NCT02931097|"~     Gait and balance disorders represent the main motor disability in advanced Parkinson's~     disease. These symptoms are less or unresponsive to levodopa treatment and are considered to~     be a contraindication for deep brain stimulation of the subthalamic nucleus. Falls and~     freezing of gait are responsible for high morbidity (fractures, residential health care) and~     increased significantly mortality. The pathophysiology of gait and balance disorders is still~     poorly understood, but recent data obtained in animals and humans suggest that a degeneration~     of cholinergic neurons of the pedunculopontine nucleus (PPN), within the mesencephalic~     locomotor region, could play a crucial role. In line with this hypothesis, low-frequency~     stimulation of the pedunculopontine area, thought to increase the activity of the remaining~     cholinergic PPN neurons, has been proposed to alleviate gait and balance disorders in~     advanced PD patients. Here, the efficacy of deep brain stimulation of the mesencephalic~     locomotor region will be tested in 12 PD patients in a randomized, double-blind, cross-over,~     controlled study.~   "
48591|NCT02930928|"~     The purpose of this prospective single center study is to investigate if the accuracy of~     length based body weight estimation by the already investigated algorithm (CLAWAR) can be~     improved by adding another parameter. For this study 500 patients are required to collect~     anonymized data (length, weight, age, mid upperarm circumference and patient habitus by~     visual estimation) for achieving a power of 80% during statistical analysis. The main~     hypothesis ist that CLAWAR's accuracy can be improved.~   "
48592|NCT02930915|"~     This study investigates the feasibility of using 3D-Printing to manufacture masks used to~     immobilize patients undergoing radiotherapy treatment for tumors affecting the head and neck.~   "
48678|NCT02929784|"~     The purpose of the study is to investigate the possibility of treating Hemiplegic Shoulder~     Pain (HSP) using transcranial direct current stimulation (tDCS) in patients following stroke.~      The secondary aims are to see if this treatment affects motor function of the upper limb, to~     asses the different types of HSP and whether there is any correlation to the location and~     extent of the stroke.~   "
48579|NCT02931084|"~     The natural course after ACL injury is not well described in the literature. Every year about~     7000 people, a majority aged 15-30 years old, injure their anterior cruciate ligament (ACL)~     in Sweden. About 3500 go through surgical treatment and rehabilitation. Despite the large~     amount of research on ACL-injuries, there are still many patients who have unsatisfactory~     outcomes regarding instability, decreased activity level, and quality of life, not being able~     to return to sport as well as an increased risk for osteoarthritis. The general aim of the~     study is to evaluate the natural course and recovery after ACL injury. Specific aims:~        -  To evaluate physical, psychological and contextual factors affecting recovery after~          anterior cruciate ligament (ACL) injury. Recovery is related both to natural course and~          to treatment chosen~        -  To evaluate factors affecting the decision for which treatment to choose (ACL~          reconstruction and rehabilitation or rehabilitation alone)~        -  To evaluate factors affecting the decision for return to sports~        -  To study development of knee osteoarthritis after ACL-injury~        -  To study epidemiology of acute knee trauma~        -  To study risk factors for new injuries after ACL-injury These aims will be pursued by~          consequently and prospectively following patients who sustain a new ACL injury in a~          multicenter study including approximately 800 patients. Assessment methods will be~          questionnaires to patients, orthopedic doctors and physical therapists. A sub-cohort of~          130 patients will undergo multiple clinical and functional examination as well as MRIs~          and blood, urine and joint fluid samples.~   "
48580|NCT02931071|"~     Fanconi anemia (FA) is a congenital disease characterized by bone marrow failure and~     increased incidence of malignant tumors. The Project pursue the optimization of the~     collection of hematopoietic progenitor cells for later use in another clinical trial entitled~     Clinical Trial Phase I/II to evaluate the safety and efficacy of the infusion of autologous~     CD34+ cells mobilized with mozobil and filgrastim, and transduced with a lentiviral vector~     carrying the FANCA gene (Orphan Drug) for patients with Fanconi Anemia Subtype A . The~     objectives of this study are, therefore, to assess the safety and efficacy of CD34+ cells~     mobilization with mozobil and filgrastim, which is postulated the most efficient for the~     collection of CD34+ cells from FA patients.~   "
48581|NCT02931058|"~     The trial investigates the efficacy of knee-extension exercise prior to total knee~     replacement. The participants are randomly allocated to one of three exercise dosages. There~     is no control group.~   "
48582|NCT02931045|"~     Platelet activation and aggregation leads to myocardial infarction. Platelet P2Y12 receptors~     are essential for platelet activation. Antagonists against the P2Y12 receptor, which are~     established in secondary prevention of myocardial infarction, have unexplained~     anti-inflammatory effects. A novel P2Y12 receptor antagonist ticagrelor reduced~     infection-related mortality compared to clopidogrel, previous standard treatment for patients~     with myocardial infarction. Activated platelets release pro-inflammatory and procoagulant~     platelet extracellular vesicles. The investigators assume that decrease in infection-related~     mortality in patients treated with ticagrelor may be explained by greater inhibition of the~     release of platelet vesicles by ticagrelor, compared to clopidogrel. This study is expected~     to identify an additional mechanism of action of ticagrelor, which might contribute to the~     observed clinical benefits in patients treated with ticagrelor.~   "
48583|NCT02931032|"~     Oral diseases tend to be exacerbated due to delayed diagnosis. Patients avoid visiting their~     dentist even for regular checkups, and develop late stage disease, jeopardizing the treatment~     outcome. There is an urgent need for an inexpensive and minimally invasive technology that~     would serve as a diagnostic aid, allowing 1) efficient early detection and 2) treatment~     customization. Diagnostic modalities based on the detection of volatile organic compounds in~     the exhaled air may answer this need.~      The proposed research aims at investigating signature molecular patterns of common oral~     diseases, as a first step toward the development of a computerized non-invasive diagnostic~     breath test, based on the Na-Nose device.~      The proposed research will be divided to three distinct stages. Stages 1-2 will serve for the~     detection and analysis of Volatile Organic Compounds connected with common oral diseases, and~     for the characterization of a specified diagnostic nano-receptor array. Stage 3 will serve~     for the clinical testing of the array and as a proof of concept.~      In a pilot experiment, headspaces above colonies of S.mutans, S.sanguis, P.gingivalis and~     F.nucleatum were trapped and analyzed using Gas Chromatography Mass Spectrometry (GC-MS). A~     unique VOC signature, consisting of 20-35 molecules, was detected for each of the bacterial~     strains.~      These promising results allow the development of an algorithm for statistical detection of~     oral diseases by their VOC profile alone. Bacteria and distressed tissues emit unique VOCs,~     and additional research is required with other types and strains of bacteria - including~     cultivation of samples from active periodontal and carious lesions.~      The results of the proposed research may be revolutionary. A simple and non-invasive air~     sampling at home or in a drugstore will significantly increase patient compliance and~     curability rates, and decrease healthcare expenditure.~   "
48584|NCT02931019|"~     For better view of fiberoptic intubation, the posture of neck is compared between neck~     flexion and extension.~   "
48585|NCT02931006|"~     50 men will be recruited to this study. Participants will be asked to ingest commercially~     available bovine milk. Hormonal profile will be analyzed before and after consumption.~   "
48586|NCT02930993|"~     This is a single-arm, open-label, one center, dose escalation clinical study, to determine~     the safety and efficacy of infusion of autologous T cells engineered to express chimeric~     antigen receptor targeting mesothelin in adult patients with mesothelin positive, recurrent~     or metastatic malignant tumors.~   "
48587|NCT02930980|"~     The purpose of the MASS2 is to characterize accelerometer signals of Micra implantable device~     during different postures and activities and to understand the source of the sensed motion,~     in order to test feasibility for future enhancements in device functionalities.~   "
48588|NCT02930967|"~     A Chimeric Switch Receptor, which was constructed by fusing the PD1 extracellular ligand~     binding domain to the CD28 intracellular costimulatory domain, was designed to target PD-L 1~     positive tumors . In this single-arm, open-label, one center, dose escalation clinical study,~     the main purpose is to determine the safety and efficacy of infusion of autologous Chimeric~     Switch Receptor modified T cells (CSR T) in adult patients with PD-L1 positive, recurrent or~     metastatic malignant tumors.~   "
48589|NCT02930954|"~     This is a single arm phase II clinical trial, which aims to evaluate the effectiveness of~     combination of gefitinib and doublet chemotherapy or antiangiogenesis in advanced non-small~     cell lung cancer patients with EGFR activating mutation, accompanied with Bim deletion or low~     activating EGFR mutation abundance.~   "
48690|NCT02929615|"~     The purpose of the study is to research the standard and individualized treatment model for~     relapse and refractory lymphatic system malignant tumors.~   "
48944|NCT02926300|"~     The purpose of this clinical trial is to evaluate long-term safety and efficacy in patients~     who has history of FURESTEM-CD injection at least once.~   "
48593|NCT02930902|"~     The goal of this clinical research is to learn about the safety and tolerability of Keytruda®~     (pembrolizumab) in combination with paricalcitol, with or without standard chemotherapy in~     patients who have resectable (can be removed with surgery) pancreatic cancer. In this study,~     standard chemotherapy is the combination of Gemzar® (gemcitabine) and Abraxane®~     (nab-paclitaxel).~      Researchers also want to learn if giving the study drugs before surgery may help to control~     the disease. The safety of this drug combination will also be studied.~      This is an investigational study. Pembrolizumab is FDA approved and commercially available~     for the treatment of melanoma and non-small cell lung cancer. Paricalcitol is FDA approved~     and commercially available for preventing hyperparathyroidism (a type of hormonal disorder).~     Gemcitabine and nab-paclitaxel are FDA approved and commercially available for the treatment~     of many cancers, including pancreatic cancer.~      It is considered investigational to use the combination of pembrolizumab and paricalcitol, by~     itself or in combination with standard chemotherapy, to treat pancreatic cancer. The study~     doctor can explain how the study drugs are designed to work.~      Up to 30 participants will take part in this study. All will be enrolled at MD Anderson.~   "
48594|NCT02930889|"~     This is a investigator-initiated evaluation of the safety and efficacy of treating benign~     prostatic hyperplasia (BPH) by prostatic artery embolization.~   "
48595|NCT02930876|"~     Cancer causes 8.2 million deaths each year, with an estimated worldwide cost of $895 billion.~     Pharmacological treatments provide improvements in expected survival and symptoms, but at~     cost of a high rate of toxicities and increased time spent by patients away from their homes~     and families during treatment. This is particularly important for patients with advanced~     disease as the timeframe at stake relates to their last months of life.~      Sarcopenia (i.e. loss of muscle mass together with decreased functional capacity) has been~     widely reported as an important prognostic factor in advanced cancer, with impact on~     survival, toxicities, response to treatment and other patient-centered outcomes (such as~     functional capacity, quality of life and fatigue).~      Sarcopenia is a term first used in 1988 by Rosenberg, meaning an age-related loss in skeletal~     muscle mass and function. It was derived from the greek: sarx = flesh and penia = loss. In~     2010, a European Consensus defined sarcopenia as a triad of muscle mass loss, decreased~     functional performance and muscle strength. It has been reported as a hallmark of cancer,~     with impact on prognosis, response to treatments, side effects of chemotherapy and recovery~     after surgery. The prevalence of sarcopenia in advanced cancer seems to vary according to~     gender, stage, primary tumor location and treatments, being present in about 28 to 67% of~     patients.~      Exercise, in particular resistance training, is one of the most powerful ways of increasing~     muscle mass and evidence from elderly patients suggests that it is among the most promising~     interventions for sarcopenia. There is evidence that resistance training can be effective but~     evidence is still scarce for patients with advanced disease. Historically there have been~     some concerns regarding safety and efficacy for oncologic patients, and though evidence~     suggests that resistance training is one of the most preferred forms of exercise by patients,~     the effectiveness of resistance training alone on sarcopenia in patients with advanced cancer~     remains unknown. Another question is whether home (which seems to be the patients' preferred~     location for exercise) produces better results than hospital (the traditional location).~   "
48596|NCT02930863|"~     This study will evaluate the effectiveness of an automated voice prompting system on post~     operative hypoxia within the Postoperative Anesthesia Care Unit (PACU). This will be done to~     detect an improvement of the patient experience and provider care through a decrease in the~     number of peripheral capillary oxygen saturation (SpO2) monitor alarms via the patients own~     ability to follow the instruction and improve their SpO2 levels.~   "
48597|NCT02930837|"~     To evaluate the safety and efficacy of alteplase when administered between 3 and 4.5 hours~     after onset of stroke symptoms in Chinese patients with acute ischemic stroke~   "
48598|NCT02930824|"~     Investigators will conduct a comparative effectiveness study of genotype-supported vs.~     conventional PPI dosing. Patients presenting with Gastroesophageal Reflux Disease (GERD) or~     dyspepsia symptoms and either 1) being initiated on proton pump inhibitor (PPI) therapy or 2)~     with continued symptoms on current PPI therapy will be recruited from gastroenterology~     clinics and randomized to a genotype-supported versus conventional PPI therapy management~     strategy.~   "
48599|NCT02930811|"~     Peripheral Arterial Disease (PAD) is a highly debilitating disease that affects 202 million~     people around the world and about 7 million people in France. Morbi-mortality from~     cardiovascular events is increased in this population. Intermittent claudication is the most~     common clinical feature of PAD.~      Primary therapeutic approach is medical treatment and advice to walk. Sildenafil, a PDEi type~     5, is well tolerated, largely used in impotence and has interesting clinical delay and~     duration of action in the concept of a potential use in claudication.~      For patients agreeing and signing informed consent, randomisation of treatment~     (placebo/sildenafil) will be done. Treatment will be proposed in addition to usual treatment.~     The experimental drug will be delivered for a 1 month treatment. First follow up visit at~     month one will focus on tolerance, compliance and eventual side effects. If no major side~     effect is found the study drug will then be delivered for an additional 2 months. Patients~     will be evaluated at month 3 (second follow-up visit) for persistent or non-persistent~     indication for revascularisation and addressed for revascularization if needed. In parallel~     focus on tolerance, compliance and eventual side effects will be done. If no major side~     effect is found, the study drug will be delivered for an additional 3 months treatment. Third~     and fourth follow-up visit are scheduled at month 6 (end of treatment) and month 9 (3 months~     after the end of experimental drugs).~   "
48600|NCT02930798|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
48601|NCT02930785|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
48602|NCT02930772|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
48603|NCT02930759|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
48604|NCT02930746|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
48605|NCT02930733|"~     Serratus plane block was first described in 2013 by Blanco and designed to primarily block~     the thoracic intercostal nerves. And this block provides sufficient analgesia lateral~     anterior and posterior part of thoracic wall.Increased use of ultrasound guidance for~     regional anesthesia in recent years has led to definition of thoracic wall PECs blocks by~     Blanco. The Serratus plain block (SPB), providing wider analgesia, with easier application~     and less adverse effects than neuroaxial blocks, has been defined after these blocks and has~     taken its place in the literature.In spite of the insufficient randomized clinical trials in~     the literature, SPB has been reported for many cases such as thoracoscopy, shoulder~     arthroscopy, breast surgery and axillary lymph node dissections, and the results are~     promising. The aim of this study is to determine effectiveness of ultrasound guided bilateral~     serratus plane block in patients undergoing breast reduction surgery.~      Main outcome measures: The primary endpoint is postoperative opioid consumption.~      Secondary endpoints are visual analogue pain scores, opioid related side effects.~   "
48606|NCT02930720|"~     Pelvic floor main role is to maintain continence. pelvic floor malfunction could lead to~     urinary incontinence (UI). The known prevalence of UI among women is 25%-72%, in about~     25%-50% it is Stress Urinary Incontinence (SUI), SUI prevalence changes with age and~     obstetric history. SUI is the complaint of involuntary leakage on activities which involves~     inter abdominal pressure rase, such as effort or exertion, or sneezing or coughing. pelvic~     floor movement is coordinated with the diaphragm, it moves caudally while inhaling and~     cranially while exhaling. it was shown that cranial sagittal displacement of the pelvic floor~     is correlated to pelvic floor normal and efficient function. in order to maintain continence~     while internal abdominal pressure rises the pelvic floor as to work in a precise trajectory,~     timing and force. observing the Urinary bladder by trans abdominal ultra sound (TAUS) was~     found as a valid and reliable way to estimate pelvic floor sagittal displacement and~     function.~   "
48607|NCT02930707|"~     Major abdominal surgeries are associated with severe abdominal pain, which can affect~     respiratory and cardiac functions, if insufficiently managed. This increases the incidence of~     post-operative morbidity.~      The objective of this study was to detect the efficacy and safety of magnesium sulphate as an~     adjuvant to the analgesia offered by local anesthetic in ultrasound guided TAP block in~     patients undergoing total abdominal hysterectomy.~   "
48608|NCT02930694|"~     The primary purpose of the study is to investigate the plasma pharmacokinetics and~     bioavailability (BA) of a single dose of a solid dose formulation with 2 different strengths~     of JNJ-54175446 (50 milligram [mg] and 100 mg capsules) relative to the suspension of~     JNJ-54175446 under fasting conditions.~   "
48609|NCT02930681|"~     Glucosanol had previously been proven to be effective in aiding weight loss and weight loss~     maintenance. Studies have also shown that Glucosanol (also known as Phaseolamin), was~     effective in aiding weight loss and also has evidence on reducing post-prandial glucose~     levels. This study is to enrich the existing evidence on dose-dependent post-prandial glucose~     effects of Glucosanol~   "
48610|NCT02930668|"~     It was proven in a previous clinical study that Glucosanol™ is effective and safe in reducing~     weight in the overweight and obese. The present study aims at expanding the data concerning~     the weight management effect of Glucosanol™ in overweight and moderately obese population.~   "
48611|NCT02930655|"~     The primary purpose of this study was to assess the safety and tolerability of lucerastat in~     adults with Fabry Disease receiving Enzyme Replacement Therapy (ERT).~      The secondary objectives were to investigate the effects of lucerastat on plasma and urine~     levels of biomarkers, to assess its effects on renal and cardiac functions and to determine~     the pharmacokinetic profile of lucerastat at steady-state.~   "
48612|NCT02930642|"~     The objective of this study is to determine the relations among food insecurity status,~     obesity, and impulsive food choice patterns and to test the extent to which a mindful eating~     strategy reduces impulsive choice for food. The central hypothesis is that food-insecure~     individuals will demonstrate more impulsive food choice patterns and demonstrate a greater~     likelihood of obesity than individuals who are food secure. Two specific aims are proposed:~      Specific aim #1: Determine the relation between food insecurity, obesity, and impulsive food~     choice patterns in women. The working hypothesis is that food-insecure individuals,~     especially those that are obese, will exhibit more impulsive food choice patterns than~     food-secure individuals.~      Specific aim #2: Determine the efficacy of an extended mindfulness-based eating strategy on~     impulsive choice patterns among food insecure women. The working hypothesis is that mindful~     eating will reduce impulsive food choice patterns relative to baseline and control~     conditions, and will persist to follow-up. The investigators expect mindful eating to reduce~     impulsive choice compared to control conditions, despite food security status.~   "
48613|NCT02930629|"~     The purpose of this study is to assess the incidence of residual block in patients arriving~     in the Post Anaesthetic Care Unit (PACU) following surgery, and in those who have received~     neuromuscular blocking drugs (muscle relaxants). Residual block (decreased motor function)~     due to residual levels of muscle relaxants is associated with increased morbidity.~   "
48614|NCT02930616|"~     Gastric intestinal metaplasia (GIM) is an important premalignant lesion for gastric cancer.~     Precisely surveillance of patients with GIM may result in early detection and improved~     prognosis. Though important, it is not necessary to recommend surveillance endoscopy for all~     patients with GIM, since the progression rate to gastric cancer within 10 years is only 1.8%~     in those patients.~   "
48615|NCT02930603|"~     A Longitudinal Study of Function and Participation in Life Activities of Patients with~     Developmental Disabilities~   "
48616|NCT02930590|"~     Pressure ulcers are severe injuries and wounds causing a substantial burden on patients,~     caregivers, and on healthcare systems worldwide. There is common agreement, that effective~     pressure ulcer prevention is of crucial importance to maintain skin and tissue integrity in~     individuals at risk. Besides risk assessment and repositioning the use of special pressure~     ulcer preventive support surfaces are the key interventions in pressure ulcer prevention.~     Pressure ulcer preventive support surface modify the degree of skin and tissue deformation~     and/or skin temperature and moisture. Therefore, an association between the type and working~     mechanism of a pressure ulcer support surface and skin function after loading is highly~     likely. Furthermore, such a relationship may be used to characterize and/or to quantify the~     performance pressure ulcer support surfaces in terms of skin protection. The overall aim of~     this explorative study is to measure skin responses of the two most common pressure ulcer~     predilection sites (heel, sacral skin) after two hours loading on three different support~     surfaces and the sternal skin (control area).~   "
48617|NCT02930577|"~     This study evaluates the factors associated with treatment adherence in substance users.~     Differences in the level of adherence to treatment according to patient-related factors,~     addiction and treatment are analyzed. The individual effect of each factor on treatment~     adherence is assessed.~   "
48618|NCT02930564|"~     The Challenge study is a prospective, open label, pilot trial in patients in deep remission~     on dietary maintenance therapy.~      The purpose of this study is to determine whether they can consume some of the products that~     were eliminated from their diet, named the Crohn's Disease Exclusion Diet (CDED), and to~     evaluate if low dose exposure is harmful.~   "
48958|NCT02926118|"~     This study test whether a Continuous Glucose Monitor can pickup differences in glucose (in~     the interstitial fluid) during a dietary intervention using meals with either a high with a~     low glycemic load.~   "
48621|NCT02930525|"~     Procedural sedation is an established and safe intervention and is widely used in diagnostic~     and therapeutic procedures for pediatric patients. Nonetheless, problems of the respiratory~     system such as upper airway obstruction, hypoventilation and apnea are frequent adverse~     events. We postulate that respiratory instability is less frequent in patients high flow~     nasal cannula vs. standard care on respiratory stability, i.e. low flow nasal cannula, in~     pediatric procedural sedation. The purpose of this pilot study is to estimate the effect of~     HFNC (high flow nasal cannula) on the respiratory instability in children undergoing upper~     gastrointestinal endoscopy under pediatric procedural sedation (PPS).~   "
48622|NCT02930512|"~     Studies show that patients with idiopathic Parkinson's disease (IPD) have an increased risk~     of fracture, particularly hip fracture whose complications and postoperative mortality appear~     to be higher than in the general population.~      This increased risk of fracture is due partly to an increased risk of falling, and secondly~     to an impairment of bone tissue with lower bone mineral density (BMD). A meta-analysis~     concluded that patients with IPD have lower BMD than healthy controls. Prospective studies~     also showed rapid bone loss in these patients compared with controls. The association between~     low BMD and IPD seems dependent on the severity and duration of the disease even if some data~     are contradictory. Various mechanisms may explain this bone loss including weight loss,~     malnutrition and a low level of physical activity. However, enrollments in these studies are~     often weak and it is difficult to conclude on the real impact of these factors on bone loss~     in the IPD. The main objective of our study is to assess and prioritize from these various~     bone loss mechanisms. Bone assessment by peripheral quantitative computed tomography (pQCT)~     will also assess the impact of various risk factors on bone strength parameters. The~     prevalence of vertebral compression fractures in the IPD, at this day unknown can be~     evaluated. This study will also estimate the prevalence of vertebral compression fractures in~     the IPD.~   "
48623|NCT02930499|"~     The purpose of this pilot study is to compare the incidence and rate of wound healing in~     subjects with venous ulcers treated with an extracellular matrix composed of hyaluronic acid~     plus compression therapy as compared to standard care. The study also intends to follow the~     subjects for a 16-week period in order to evaluate ulcer recurrence within treatment groups.~   "
48624|NCT02930486|"~     Treatment of syndesmotic injury with Weber C fracture. A randomized study comparing ZipTight~     suture endobutton and one tricortical 3,5 mm syndesmotic screw.~   "
48625|NCT02930473|"~     This study aims to evaluate the efficacy of a psychotherapeutic intervention model in nursing~     on the nursing diagnosis Anxiety. A randomised controlled trial will be carried out to do~     so.~   "
48626|NCT02930460|"~     Prospective observational study of obstructive Sleep Apnea patients treated with Bilevel~     Positive Airway Pressure: AirCurve 10 VAutoTM~   "
48627|NCT02930447|"~     Autologous glue therapy with platelet-rich plasma (PRP) was reported to improve outcomes in~     plastic surgery. However, only pilot studies and retrospective uncontrolled trials have~     reported the potential benefits of autologous glue treatment up to now. Therefore, a larger,~     blinded, randomized and placebo-controlled clinical trial would be useful to determine~     whether platelet-rich plasma is safe and effective in abdominoplasty procedures.~      Currently, there are pharmacological options such as artificial fibrin glues composed of~     homologous fibrinogen and animal-derived thrombin. However, these therapeutics present a risk~     of transmissible diseases and may induce allergic reactions. Therefore, autologous glues,~     which are fully made of blood components from the patient itself (autologous fibrinogen~     contained in PRP and autologous thrombin) represents a safe alternative to artificial~     biological glues.~      Regen Lab SA developed RegenKit®-Surgery to prepare autologous PRP, on one hand, and an~     autologous activated thrombin serum, on the other hand, in a safe and rapid manner.~     RegenKit®-Surgery is a CE-marked class IIb medical device.~      This study, conducted on 56 patients, will evaluate the effects of autologous glue prepared~     with RegenKit®-Surgery when used in reconstructive abdominoplasty.~   "
48628|NCT02930434|"~     The purpose of this study is to evaluate vitamin D (VD) deficiency in the population of~     Chilean Antarctica and evaluate the efficacy and safety of VD supplementation to decrease VD~     deficiency and favorably influence biomarkers for bone, cardiovascular, and immune health~     risk in the inhabitants of Chilean Antarctica.~   "
48629|NCT02930421|"~     The primary aim of this clinical study is to investigate if exercise training can improve~     exercise capacity and quality of life in dyspneic mild chronic obstructive pulmonary disease~     patients.~   "
48630|NCT02930408|"~     Steinert's disease is an orphan disease. The prognosis of patients with this disease is~     conditioned by cardiac involvement. Search an early stage alterations in contractile function~     in subjects suffering from dystrophy would detect patients at risk of sudden death. The first~     stage of work is to validate the tools to detect early stage of infringement systolic~     function in a population of patients with myotonic dystrophy.~   "
48631|NCT02930395|"~     In the past 20 years, the incidence of concussion in direct contact sports has significantly~     increased. The incidence of concussion in rugby players ranges between 8 to 17 episodes /~     1000 playing hours. A recent study published by the French Rugby Federation (FFR) and the~     National Rugby League (LNR) showed similar results. The latter study was performed analyzing~     the French TOP14, which includes 14 teams participating in professional rugby~     championships. At least two concussions were diagnosed each week. Despite the recent~     evidence, cognitive assessment remains the only means to determine whether or not players~     experiencing concussions can return to the game or not.~   "
48632|NCT02930382|"~     We must implement 8 implantable cardioverter defibrillators (ICDs) to save a life in 3 years~     after myocardial infarction (MI) in primary prevention.~      Only the ejection fraction of the left ventricle (LVEF) is used as a tool for risk~     stratification of sudden death after myocardial infarction.~      Several studies have shown that impairment of spontaneous baroreflex sensitivity (BRS) after~     MI was predictor of sudden death.~   "
48633|NCT02930369|"~     The purpose of this study is to determine the effects of two different internal limiting~     membrane (ILM) peeling area on anatomical closure outcomes after macular hole surgery~     measured by optical coherence tomography (OCT).~   "
48634|NCT02930356|"~     This study is intended to measure hepatocyte growth factor levels in smokers and non smokers~     with periodontitis before and after non surgical periodontal therapy.~   "
48635|NCT02930343|"~     RA (Rheuatoid arthritis) is a multisystem disease that mainly involves joints resulting in~     destructive arthritis if not treated rapidly. Inspite of various advances in field of early~     diagnosis and treatment of RA, there is still a need for better understanding of the efficacy~     and safety of various combinations of conventional DMARDS, and to rank them in order~     accordingly, so as to give a clearer vision for further management of RA once MTX monotherapy~     fails, so as to achieve remission as soon as possible. The study will be conducted at the~     Department of Clinical Immunology, JIPMER (Jawaharlal Institute of Postgraduate Medical~     Education & Research). patients who fail methotrexate monotherapy will be randomised to 2~     treatment arms - either a combination of Sulfasalazine (SSZ), Hydroxychloroquine (HCQ) and~     Methotrexate (MTX) or Leflunomide (LEF), Hydroxychloroquine (HCQ) and Methotrexate (MTX)~   "
48636|NCT02930330|"~     The purpose of this study is to determine whether high intensity interval training (INT) is~     more effective in suppressing platelet reactivity than continuous, moderate intensity~     training (CONT) in patients undergoing cardiac rehabilitation after percutaneous coronary~     intervention.~   "
48637|NCT02930317|"~     Efficacy, Safety and Pharmacokinetics Study of a rFVIII in Chinese subjects with Hemophilia~     A.To assess efficacy and safety of rFVIII administered as treatment and as on-demand therapy~     in adult and adolescent (12-65 years) patients with severe or moderately severe Hemophilia A.~     To determine the pharmacokinetic (PK) parameters of rFVIII.~   "
48638|NCT02930304|"~     Lateral epicondylitis (tennis elbow) is a painful musculoskeletal condition, which is~     considered to be due to overuse, over-stress or over-exertion of the wrist extensors of the~     forearm, especially extensor carpi radialis brevi.~      The aim of this study is to The compare the short-term effects of different physiotherapy~     approaches on pain, function and grip strength in the rehabilitation of patients with lateral~     epicondylitis.~   "
48639|NCT02930291|"~     The purpose of this study is to explore the effect of preoperative inflammation-based scores~     on postoperative morbidity and mortality for laparoscopic gastrectomy.~   "
48640|NCT02930278|"~     The purpose of this study is to explore the effect of preoperative hemotologic markers on~     postoperative long-term and short-term outcomes for laparoscopic gastrectomy.~   "
48641|NCT02930265|"~     It has been known that liraglutide reduces infarct size, improved left ventricular function,~     reduce myocardial stunning, and play a protective role in myocardial ischemia-reperfusion~     injury for patients with acute myocardial infarction. But it is not sure whether liraglutide~     can benefit patients with ischemic cardiomyopathy. This study aim to explore the effect of~     Liraglutide in improving cardiac function for patients with ischemic cardiomyopathy.~   "
48642|NCT02930252|"~     The purpose of this study is to compare the duration of stent patency of a covered vs. an~     uncovered biliary self-expandable metal stents (SEMS) placed to relieve biliary obstruction~     in patients with inoperable extrahepatic malignant biliary obstruction.~   "
48643|NCT02930239|"~     A randomized control trial where subjects following an anterior cruciate ligament~     reconstruction will be randomized to either a control group who will receive the normal~     rehabilitation or an experimental group who will perform a 2-week gait rehabilitation using~     the anti-gravity treadmill in addition to the normal rehabilitation. The intervention will be~     added to the existing care received at Linkoping University Hospital 2 weeks post-surgery,~     while the evaluation will be performed in week 5 and 12 post-surgery using: a 3D-gait~     analysis (with the Qualisys software), self-reported function questionnaires and a clinical~     examination.~   "
48644|NCT02930226|"~     Assess the safety of single infusions with RePlas FDP product at increasing fixed doses~   "
48645|NCT02930213|"~     In this study, the core body temperature of 7 disorders of consciousness ( DOC ) patients~     were measured every 2 hour for 168 h .~   "
48646|NCT02930200|"~     The primary long-term objective of this research is to reduce smoking relapse through the use~     of automated mobile smoking cessation interventions that tailor content (e.g., treatment~     messages/materials) in real-time based upon currently present symptoms. The primary~     short-term objective of this pilot study is to determine the initial utility of a novel~     smartphone based smoking cessation intervention compared with standard in-person smoking~     cessation clinic care and the free National Cancer Institute (NCI) QuitGuide smoking~     cessation application. The current pilot study is a 3 armed randomized clinical trial that~     aims to determine the initial utility of a novel smartphone based smoking cessation~     intervention compared with standard in-person smoking cessation clinic care and the free NCI~     QuitGuide smoking cessation application.~   "
48647|NCT02930187|"~     Evaluate correlations between the validated 12 joints-Naredo ultrasound score (B-mode (0-3),~     PD (0-3) or PDUS (0-3, max between B-mode or PD)) and the DAS28-ESR, DAS28-CRP, CDAI, SDAI~     and ACR-EULAR criteria for remission in routine care.~   "
48648|NCT02930174|"~     This study is being done to further the investigators' knowledge of the EIT system and to see~     if measures between two non-invasive ventilation systems routinely used clinically are~     equivalent.~   "
48649|NCT02930161|"~     The study is designed to assess the safety and efficacy of different doses and dosing~     regimens of Runihol, tablets, enteric coated, produced by NTFF POLYSAN (Russia), in~     prevention of liver disease progression in patients with non-alcoholic fatty liver disease~     and metabolic syndrome.~   "
48650|NCT02930148|"~     the aims of the present study is to test the PEGASO system in real life conditions in~     Lombardy (Italy), England and Scotland (UK) and Catalonia (Spain), as well as to assess~     changes in teen-agers' awareness and lifestyles after the use of PEGASO system. Specifically,~     the investigators aim to:~        1. To test the usability of PEGASO platform~        2. To pilot approaches to testing the effectiveness of the system to:~             1. Evaluate the increase of knowledge/awareness about healthy habits~             2. Assess behavioural change in lifestyle, and specifically on target behaviours In~               particular, the pilot study will help to assess likely recruitment and retention in~               a controlled trial, to test the acceptability and utility of assessment procedures,~               to obtain estimates of effect size and variability to power a future substantive~               study~   "
48651|NCT02930135|"~     The aim of this study is to compare the clinical and radiographic success of indirect pulp~     capping of vital young permanent teeth with deep caries using two-step antibacterial bonding~     system versus conventional one.~   "
48652|NCT02930122|"~     Injury to the knee during sports participation often involves partial or full detachment of~     the anterior cruciate ligament (abbreviated as ACL). ACL tears cause pain, swelling and~     inflammation. While the swelling and inflammation usually goes away in time, individuals with~     ACL injuries may experience pain and notice knee instability (knee slipping, etc.). Often~     surgery can repair or replace the ACL within the joint, allowing individuals the ability to~     walk or run again pain free or participate in sports. Unfortunately, osteoarthritis of the~     knee, which also causes pain and swelling, can occur in that same knee 10-20 years later for~     reasons which are not well understood.~      In this research study, the investigator hopes to reduce the initial pre-operative pain. The~     reduction of pain will allow for earlier movement of the knee joint and preparation for~     surgery. The investigator is interested to see if the use of Kineret does decrease the risk~     of developing arthritis in individuals with ACL injuries by treating them within 1-7 days~     after their injury.~   "
48653|NCT02930109|"~     A phase I-II open label study of PTX-200 in combination with cytarabine in the treatment of~     relapsed or refractory acute leukemia.~   "
48654|NCT02930096|"~     To evaluate the pulsatility index changes after setting supine position in non brain- injured~     patient under general anesthesia.~   "
48655|NCT02930083|"~     To improve activities of daily living (ADL) and social functions is the important treatment~     plans and goals in participants with schizophrenia. Precise and effective measures of ADL and~     social functions are critical for clinicians to set up appropriate treatments plans, follow~     up participants' changes, and understand participants' progress. Three common measures of ADL~     and social functions used in participants with schizophrenia were the Comprehensive~     Occupational Therapy Evaluation Scale (COTES), the Activities of Daily Living Rating Scale~     third ed. (ADLRS-3), and the Social Functioning Scale. To investigators' knowledge,~     psychometric properties of these assessments have not been examined in participants with~     schizophrenia. Therefore, the purpose of the study is to (1) examine internal consistency and~     construct validity of these 3 assessments (the COTES, the ADLRS-3, and the Social Functioning~     Scale); and (2) calculate missing rate of self-report assessment (the ADLRS-3 and the Social~     Functioning Scale). Investigators expect that these results of internal consistency,~     construct validity and/or missing rate will provide empirical evidence for using these three~     measures in both clinical and research setting.~   "
48656|NCT02930070|"~     The new definition of sepsis (sepsis 3.0) restricts the early diagnosis of sepsis in general~     wards. Despite an alternative process by using a simplified qSOFA score, many patients may~     still be left out. Whether these patients matter or not is unknown. This prospective cohort~     includes patients from ten general wards with high incidence of infection during a~     consecutive half year, obtains qSOFA and SOFA score, follows up prognostic data, therefore to~     compare patients under different groups, eventually to evaluate the diagnostic accuracy of~     qSOFA score in diagnosis of sepsis.~   "
48657|NCT02930057|"~     The purpose of this study is to examine the potential changes in levels of pain, quality of~     life (QoL) and activities of daily living (ADL) observed when transforaminal epidural steroid~     injection is administered in conjunction with pulsed radiofrequency treatment of the lumbar~     dorsal root ganglion during the initial 3 months follow-up period. Safety (monitoring side~     effects) of the treatment is determined.~      The study hypothesis is that the application of transforaminal epidural steroid injection~     (TFESI) in conjunction with pulsed radiofrequency treatment (PRF) treatment of the lumbar~     dorsal root ganglion would increase the treatment response of PRF and thereby provide a~     measurable difference in the pain scores, quality of life and activities of daily living for~     the patients suffering from chronic lumbosacral radicular pain.~   "
48658|NCT02930044|"~     The purpose of this study is to determine whether adult DKA patients who present to the~     emergency department treated with early subcutaneous long acting insulin versus standard care~     receive a shorter total duration of intravenous (IV) insulin infusion.~   "
48659|NCT02930031|"~     In this investigation the investigators utilized N-acetylcysteine (NAC) supplementation to~     enhance reduced glutathione (GSH) stores during an 8-day recovery period from a strenuous~     eccentric exercise protocol in order to test the hypotheses: i) redox status perturbations in~     skeletal muscle are pivotal for the immune responses and ii) antioxidant supplementation may~     alter immune cell responses following exercise-induced muscle microtrauma.~   "
48660|NCT02930018|"~     The ESCAPE-NA-1 study is designed to determine the safety and efficacy of the~     neuroprotectant, NA-1, in reducing global disability in subjects with major acute ischemic~     stroke (AIS) with a small established infarct core and with good collateral circulation who~     are selected for endovascular revascularization.~   "
48661|NCT02930005|"~     This study evaluates the feasibility of administering meclofenamic acid or pentosan~     polysulfate sodium as an adjunctive treatment to patients diagnosed with a psychotic~     disorder. Half of participants will receive meclofenamic acid, while the other half will~     receive polysulfate sodium.~   "
48662|NCT02929992|"~     The investigators propose the Delivery Optimization for Antiretroviral Therapy Study - The DO~     ART Study - a prospective randomized study of strategies to optimize community-based ART~     initiation, monitoring and resupply among HIV-positive persons in South Africa and Uganda.~     The investigators will work closely with community members, stakeholders, local providers,~     and the local Department of Health (DoH) to integrate the community-based ART delivery with~     HIV clinics, pharmacies and labs. Following community sensitization, participants will be~     recruited through community-based HTC and HIV clinics. HIV-positive persons not engaged in~     care will receive point-of-care CD4 testing to determine ART eligibility. HIV-positive~     persons who are eligible for ART by national guidelines will be randomized to one of three~     ART delivery arms: (i) Home ART initiation and mobile van ART monitoring and resupply, (ii)~     Hybrid model with clinic ART initiation and mobile van ART monitoring and resupply, and (iii)~     Clinic ART initiation, monitoring and resupply - the current standard of care (SOC)~   "
48676|NCT02929810|"~     Emerging evidence suggests that approximately 30% of the US adult population sleeps less than~     7 hours per night, and those who do exhibit 20-52% enhanced risk to develop cardiovascular~     diseases and particularly hypertension. Since sleep curtailment is largely voluntary, sleep~     deficiency can be corrected and its detrimental health consequences potentially reversed. The~     purpose of the present proposal is to investigate the cardiovascular and metabolic effects of~     sleep extension in prehypertensive and stage 1 hypertensive subjects who report habitual~     short sleep.~   "
48663|NCT02929979|"~     The project will examine whether a computerized neuroscience-based cognitive training program~     can improve cognitive functioning and recovery outcomes among Veterans with Alcohol Use~     Disorder and co-occurring PTSD. Information from this study will help determine the~     malleability of cognitive dysfunction, an established risk factor for poor recovery outcomes~     in this population. Improved functional outcomes can decrease risk of chronic impairment and~     ultimately help affected individuals live richer, more productive lives. Web-based treatment~     technologies may increase the reach and impact of treatment, and foster patient recovery in~     cases where staffing, space, acceptability of counseling, and transportation are barriers.~     Findings may also support expanding use of existing, highly-accessible cognitive remediation~     technologies to other vulnerable clinical populations.~   "
48664|NCT02929966|"~     The investigators will examine the effect of introducing palliative in patients with~     end-stage idiopathic pulmonary fibrosis, refractory to the pharmacological treatment or not~     deemed to be treated, on patient-reported outcomes and end-of-life care. The investigators~     will randomly assign patients who receive either early palliative care integrated with~     standard respiratory care or standard respiratory care alone.~      Quality of life and symptoms will assessed at baseline and at 12 weeks The primary outcome~     will be the change in the quality of life and symptoms at 12 months.~   "
48665|NCT02929953|"~     The aims of this study are:~        1. To assess the prevalence of prematurity, especially early prematurity, among T1D~          patients, and compare it to the prematurity prevalence among the non-diabetic general~          population in Israel.~        2. To characterize epidemiological and clinical factors that differ between premature-born~          patients that developed T1D and those that have not, including the nutritional and~          therapeutic properties in NICU.~   "
48666|NCT02929940|"~     Alpha1-antitrypsin deficiency (AATD) is the third most common genetic disorder leading to~     death worldwide. Apart from lung disease, AATD also leads to liver involvement in up to 50%~     of patients. Hence, liver involvement is the second most common cause of morbidity and~     mortality in AATD patients. But the natural history of disease in adults is not well~     understood and specific therapies are still in the phase of preclinical studies. Despite~     these facts and the therapeutic and preventative potential, the AATD-related liver disease is~     still largely being neglected by both the patients and the healthcare professionals.~      To improve the hepatologic care of patients with AATD, the investigators initiated a~     prospective multi-center study in Europe that systematically evaluates the liver function in~     these patients and their relatives. The investigators cooperate with both patient~     organizations as well as with lung centers specialized on AATD-related lung disease.~   "
48667|NCT02929927|"~     This study tries to collect clinical cases to compare the clinical effect of traditional root~     canal disinfection, to photodynamic in root canal disinfection .And provide the reference for~     clinical application and experience.~   "
48668|NCT02929914|"~     The aim of the proposed study is to assess the clinical effect of photodynamic therapy~     (PDT)using LED on dentin with carious lesions in permanent teeth. Patients with molars~     exhibiting deep carious lesions on the occlusal surface indicated for restorative treatment~     will be randomly allocated to two groups: Group 1 -Control after incomplete caries~     removal,indirect pulp treatment with calcium hydroxide(CH); Group 2 - PDT + CH after~     incomplete caries removal,disinfect the residual dentin with PDT(LED + methylene),then~     indirect pulp treatment with CH. Dentin samples will be removed before and after PDT for~     microbiological analysis. The microbiological samples will be cultured in Brucella blood~     agar, Mitis Salivarius-bacitracin agar and Rogosa Selective Lactobacillus agar. The teeth~     will then be restored using resin with clinical and radiographic follow up at six, 12 and 24~     months. The data will be submitted to descriptive statistics.~   "
48669|NCT02929901|"~     The purpose of this study is to investigate the effects of coffee main constituents (caffeine~     and chlorogenic acid) supplements on inflammatory, metabolic factors, hepatic steatosis and~     fibrosis in none- alcoholic fatty liver patients with type 2 diabetes. Two hundred patients~     with fatty liver and type 2 diabetes will be randomly assigned to one of four groups: group~     1, caffeine (200 mg/d) plus chlorogenic acid (200 mg/d); group 2, caffeine (200 mg/d) plus~     placebo; group 3, chlorogenic acid (200 mg/d) plus placebo; group 4, placebo plus placebo.~     Supplementation will be daily and will supervise for 6 months.~   "
48670|NCT02929888|"~     Prasugrel and ticagrelor, new P2Y12-ADP receptor antagonists, are associated with greater~     pharmacodynamic inhibition and reduction of cardiovascular events in patients with an acute~     coronary syndrome. However, evidence is lacked about the effects of achieving faster and~     stronger cyclooxygenase inhibition with intravenous lysine acetylsalicylate (LA) compared to~     oral aspirin on prasugrel inhibited platelets. Recently, we demonstrated in healthy~     volunteers that the administration of intravenous LA resulted in a significantly reduction of~     platelet reactivity compared to oral aspirin on prasugrel inhibited platelets. Loading dose~     of LA achieves platelet inhibition faster, greater and with less variability than aspirin.~     However, there are no data of this issue in patients with an ST-segment elevation myocardial~     infarction (STEMI). The ECCLIPSE-STEMI trial will study the effect of LA versus aspirin in~     platelet reactivity in patients with STEMI~   "
48671|NCT02929875|"~     In an experimental research, 100 nulliparous pregnant women who had referred to health care~     centers in Kermanshah were randomly selected and after taking Written Informed Consent~     letter, assigned into case and control groups. instruction based on TPB was provided just for~     the case group. Afterwards, post-test was taken by both groups and the results were analyzed.~   "
48672|NCT02929862|"~     This is a Phase 1/2A study designed to evaluate the safety and tolerability of increased~     repeated doses of LYC-55716 in subjects with locally advanced or metastatic solid tumors.~   "
48673|NCT02929849|"~     The purpose of this study is to determine whether an herb with known alpha-glucosidase~     inhibitor properties (Salacia Chinensis, SC), affects postprandial appetite ratings and~     glucose indices in overweight/obese individuals.~   "
48674|NCT02929836|"~     This randomized prospective study compared three ablation strategies in patients with~     longstanding persistent atrial fibrillation (LPeAF). It also explored the best procedural~     endpoint from among the following: circumferential pulmonary vein isolation (PVI)+left atrial~     (LA) linear lesions (roof line, mitral isthmus)+complex fractionated atrial electrogram~     (CFAE) ablation, PVI+LA linear lesions +cavotricuspid isthmus (CTI) ablation +CFAE ablation,~     and PVI+CFAE ablation.~   "
48679|NCT02929771|"~     This study will assess the impact of virtual reality (VR) in decreasing procedural pain~     related to subcutaneous port (SCP) access in children with cancer. The study is a~     pilot-randomized controlled trial (RCT) using a cross-over design that will provide us with~     detailed information on the feasibility of implementing our trial protocol in a future~     multi-center RCT as well as preliminary estimate of VR treatment effect on children with~     cancer undergoing SCP access, including child and parent factors potentially associated with~     VR distraction treatment efficacy.~   "
48680|NCT02929758|"~     The purpose of this prospective, within-subject randomized cross-over design study is to~     determine if a computer training program (Speed of Processing Training - SOPT) improves safe~     pedestrian behavior in patients with Parkinson's disease and in healthy older adults in a~     virtual reality pedestrian environment. Pedestrian injury poses significant risk to healthy~     older adults and patients with Parkinson's disease. Several age-related changes, including~     slowing of visual processing speed, increase risky pedestrian behavior. This study will~     determine if SOPT improves pedestrian behavior in patients with Parkinson's disease and~     healthy older adults and evaluate the persistence of the SOPT training effects.~   "
48681|NCT02929745|"~     The purpose of this study is to understand how genetics play a role in psoriasis.~     Specifically, a genetic allele HLA-Cw6 is known to be associated with psoriasis, and this~     study aims to find out how it affects genetic and protein expression in patients with~     psoriasis, compared to healthy people, at a single-cell level using a novel flow cytometry~     and RNA-sequencing protocol.~   "
48682|NCT02929732|"~     Willis-Ekbom disease (WED), also known as restless legs syndrome (RLS) is a common~     neurological sensorimotor disorder that typically impairs sleep and quality of life, likely~     consequent to a central dopaminergic dysfunction associated to brain iron deficiency.~     Periodic limb movements (PLMS) in sleep are present in 80% of patients with WED. PLMS are~     often associated with micro-arousals that contribute to sleep fragmentation and repeated~     increases of blood pressure and heart rate throughout the night, thus representing an~     increased risk for hypertension and cardiovascular diseases (CVD).~      Willis-Ekbom disease affects people with higher cardiovascular risk factors, such as advanced~     age, obesity, diabetes mellitus and hypercholesterolemia. However, previous observational,~     cross-sectional or longitudinal population-based studies on the association between RLS and~     CVD and hypertension showed controversial results.~      While the pathophysiology of RLS is yet to be elucidated and is likely multifactorial, one~     theory involves a reduction in dopaminergic outflow to the preganglionic sympathetic neurons~     in the dorsal horn of the spinal cord. Dopamine inhibits preganglionic sympathetic neurons,~     therefore a reduction in dopamine may in turn increase sympathetic outflow.~      Based on this notion, the investigators hypothesize an increase of sympathetic autonomic~     activity in Willis-Ekbom disease responsible for the recurrent increase in blood pressure and~     heart rate during sleep, which may play a role in increasing the risk of cardiovascular~     diseases.~      The aim of this study is to analyze the autonomic nervous activity in patients with WED~     compared to healthy volunteers controls. The investigators will measure primarily the cardiac~     sympathetic activity by the 123I-metaiodobenzylguanidine (123I-MIBG) scintigraphy and~     secondarily the sympathetic nerve activity by the microneurography, the plasmatic pro~     inflammatory biomarkers and urinary catecholamine levels and the circadian variation of blood~     pressure and heart rate as assessed by the 24-hour ambulatory blood pressure monitoring.~   "
48683|NCT02929719|"~     Therapeutic equivalence and safety study~   "
48684|NCT02929706|"~     NUDT15 R139C was comfirmed to be associated with thiopurine-induced leukopenia inflammatory~     bowel disease (IBD) cohort.The present study aim to explor the following questions:can~     optimizing thiopurine dose by NUDT15 genotype reduce thiopurine-induced leucopenia?What is~     the influence of this optimizing strategy on clinical outcome?Thus,we conduct a randomised~     controlled study.Subject in the conventional group detect NUDT15 genotype before thiopurine~     use and optimise dosage according to the genotype.While the subjects in the control group~     follow the conventional monitor strategy.The primary endpoint was the rate of leukopenia.The~     secondary endopoint was the efficacy of thiopurine.The follow up duration was 1 year.~   "
48685|NCT02929693|"~     The investigators performed a multi-centered, randomized, double blinded, placebo-controlled,~     prospective clinical trial on the effect of Yiqi-yangyin-jiedu decoction (YYJD), a chinese~     herbal medicine (CHM) formula combined with gefitinib to prolong the progression free~     survival (PFS) of advanced pulmonary adenocarcinoma patients with activating EGFR mutation~     (exon19del or exon21L858R). The investigators plan to enroll 198 cases in 3 years (99 cases~     for gefitinib, 99 cases for gefitinib plus YYJD), expecting that combination therapy has a~     better efficacy on prolonging PFS, overall survival, improving quality of life(QOL).~   "
48686|NCT02929667|"~     Sudden unexpected death in epilepsy patients (SUDEP) is devastating outcome for some patients~     with epilepsy. It ranks second only to stroke among neurological diseases in years of~     potential life lost. Patho-mechanisms of SUDEP remain not well understood, however peri-ictal~     respiratory dysfunction likely plays an important role in many cases.~      Literature supports a critical role for the serotonergic system in central control of~     ventilation. Serotonin neurons in the raphe nuclei of the brainstem sense rising carbon~     dioxide and low pH, thereby stimulating breathing and arousal. These responses may serve as~     mechanisms that protect against asphyxia, particularly during sleep or the post-ictal state.~     In mouse models of seizure-induced sudden death, pre-treatment with selective serotonin~     reuptake inhibitor (SSRI) agents prevents death following seizures. Hence, the investigators~     hypothesize that a subset of drug resistant epilepsy patients who have impaired central~     chemo-responsiveness have a greater degree of peri-ictal respiratory depression, therefore a~     higher risk of SUDEP. The investigators further hypothesize that fluoxetine will improve~     central chemo-responsiveness and therefore will reduce peri-ictal respiratory depression.~   "
48687|NCT02929654|"~     To investigate whether novel insight features in new BGMs can improve glycemic control.~   "
48688|NCT02929641|"~     When a polyp is found, it woulf be recorded by a white-light and OE1 model with magnification~     for assessing and predicting its histology. After that, its really histology will be reported~     by an pathologist.~      When a polyp is found, OE mode 1 with magnification was first used with near focus the polyp~     and an endoscopist made a real-time prediction of polyp pathology. After that,~     high-definition mode and OE mode 1 without magnification were used to observe polyp~     sequencely. The video of all procedure was recorded.~   "
48689|NCT02929628|"~     Patients with an implantable electrical nerve stimulation system Patient criteria included:~     over 18 years of age,MMSE≥ 24 score; H-Y stage in medicine off condition＞2.0;an ability to~     walk at least 10 meters independently;subscore≥2 for UPDRS part II item 15;subscore ＞1 for~     UPDRS part II item 14; permissions given by informed consent. Patients with serious diseases~     such as tumor, sever liver or kidney dysfunction were not selected in the clinical trials.~     Subjects participating in other clinical trials related or not related to these trials were~     not chosen.~   "
48691|NCT02929602|"~     Opioid analgesics prescribed by dentists may contribute to the larger national issue of the~     use and abuse of the drug. On occasion dental pain may be sufficiently severe to support the~     use of opioids. This study used both dentist and patient input to evaluate the use of opioid~     and over-the-counter analgesics following one of seven coded common dental procedures. The~     study includes a five day patient follow up assessment of the effectiveness of the analgesic.~     Baseline questionnaires were completed by eligible participants, and they responded to the~     day 5 follow up questionnaires.~   "
48692|NCT02929589|"~     This is a prospective, randomized, double-blinded, and placebo-controlled trial comparing~     oxycodone/acetaminophen prescribed with or without ibuprofen for pain control following open~     unilateral inguinal hernia repair, with allowed exception of any currently prescribed opioid~     (codeine, hydrocodone, hydromorphone, morphine, methadone, oxymorphone, transdermal~     fentanyl), which can be continued. The patients will not be allowed to continue any~     over-the-counter pain medications, such as ibuprofen, naproxen, or acetaminophen containing~     medications, that were not prescribed by the investigators during this study. Patients not~     receiving Ibuprofen will be given a placebo pill composed of corn starch. The placebo pill~     will be formulated into the same shape, size and color as the ibuprofen capsule. Neither the~     investigators nor the research subjects will know if the subject is receiving a placebo~     versus Ibuprofen. The subjects will complete pain level and medication diaries, and will be~     followed for 2 months after their surgery. The research aims to discover the appropriate~     amount of opioid medication to prescribe to patients undergoing an elective open inguinal~     hernia repair, and reduce the total opioid dose needed by utilizing ibuprofen in combination.~     The investigators expect that the subjects who take ibuprofen will use less~     oxycodone/acetaminophen, and have comparable or lower mean pain levels. This could contribute~     to reducing the surplus opioids prescribed by physicians after surgery, which can lead to~     opioid use disorders. This particular procedure is common in men, and the findings have the~     potential to decrease the symptoms and pain of Active Duty members and DoD beneficiaries who~     undergo an inguinal hernia repair, and are at risk for prescription drug abuse or dependence.~   "
48693|NCT02929576|"~     The purpose of this study is to evaluate and compare the clinical benefit and safety of~     treatment with enzalutamide in combination with paclitaxel chemotherapy or as monotherapy~     versus placebo with paclitaxel in patients with locally advanced or metastatic,~     diagnostic-positive, triple-negative breast cancer (TNBC).~   "
48694|NCT02929563|"~     This study tests the feasibility of a large study of stress ulcer prophylaxis in critically~     ill children. Children admitted to the Pediatric Intensive Care Unit who are expected to~     require mechanical ventilation for more than 48 hours will be randomized to intravenous~     pantoprazole 1 mg/kg or matching placebo once daily until they no longer need mechanical~     ventilation.~   "
48695|NCT02929550|"~     Methods: All patients <75 years registered in the Swedish Secondary Prevention after Heart~     Intensive care Admission registry (SEPHIA), will be followed-up within one year~     post-myocardia infarction (MI). The REACH risk prediction and a calibrated model for~     recurrent cardiovascular disease (CVD) events and death will be used to estimate base case,~     and calibrated CVD outcomes based on gender-specific risk factors. The predicted impact of~     the LDL-C reduction on the risk of CVD will be based on Cholesterol Treatment Trialists´~     Collaboration findings.~   "
48696|NCT02929537|"~     With the comparative effectiveness research methods and hospital registration study approach,~     the purpose of this study is to objectively record the methods, efficacy and its influencing~     factors of COPD commonly used treatment methods/programs (Western medicine, Traditional~     Chinese Medicine and Integrative Medicine) in the actual medical environment, analysis of~     application characteristics for the different programs, and provide the basis for its~     revision and promotion. It is a first registration study for COPD in China.~   "
48697|NCT02929524|"~     Randomized clinical trial, controlled, double-blind, parallel two-arm.~   "
48698|NCT02929511|"~     In this study, the researchers will investigate the effect of single-file reciprocating~     versus single-file rotational file systems on the postoperative pain in adult patients who~     have necrotic pulp and apical periodontitis. The participants will be assigned by chance to~     separate groups that compare 2 different treatments, reciprocating single-file system~     (Reciproc Blue) and rotational single-file system (OneShape). As a reference, Mtwo multi-file~     (full-sequence) will be used.~   "
48699|NCT02929498|"~     This is a Phase I/II, open-label, 2 arm study to evaluate the safety and clinical activity of~     GSK2879552 alone, or in combination with azacitidine in subjects with MDS. The study~     consisted of 2 parts. The objective of Part 1 is to determine the recommended phase 2 dose~     (RP2D) of GSK2879552 administered alone and in combination with azacitidine in adult subjects~     with high risk MDS previously treated with HMA. The objective of Part 2 is to evaluate~     clinical activity after treatment with GSK2879552, alone or in combination with azacitidine,~     in adult subjects with high risk MDS previously treated with HMA.~   "
48700|NCT02929485|"~     In this study, the investigators are looking at how people make decisions about~     reward-related items, both monetary and food related after taking either the dopamine agonist~     bromocriptine or the COMT inhibitor tolcapone, in healthy control subjects. Subjects will~     fill self-report questionnaires and undergo an MRI scan.~   "
48710|NCT02929355|"~     Diabetes is a risk factor for carotid atherosclerotic whose progression is associated with an~     increased risk of vascular events. Investigators assessed prospectively by arterial duplex~     ultrasonography the progression of carotid atherosclerosis in a cohort of people with~     diabetes to assess the importance of progression and to analyze the impact of this~     progression on vascular events. The main hypothesis is that people with carotid~     atherosclerosis progression are at higher risk of vascular events than those without any~     progression.~   "
48711|NCT02929342|"~     The purpose of this study is to better define the absorption and elimination pathways, and~     circulating metabolites of Pitolisant at steady state using Pitolisant radiolabelled, in~     healthy CYP2D6 genotyped male subject.~   "
48712|NCT02929329|"~     The purpose of this study is to determine if treatment with omecamtiv mecarbil/AMG 423 when~     added to standard of care is well tolerated and superior to placebo in reducing the risk of~     cardiovascular death or heart failure events in subjects with chronic HFrEF.~   "
48701|NCT02929472|"~     The aim of this study was: to evaluate the effectiveness of a multicomponent pilot~     intervention in improving physical fitness (PF) and metabolic risk markers in children and~     adolescents; and examine if possible changes in PF are associated with metabolic risk markers~     in children and adolescents exposed to intervention. For such, a multicomponent pilot~     intervention was performed, consisting of sessions of physical exercise and nutrition~     education.The study included 35 children and adolescents (ages 7-13) divided into two groups:~     a intervention group (INT, n = 17) and a control one (CONT, n = 18). The sample underwent two~     moments of data collection (T0 and T1). The 1-hour exercise sessions were held based on an~     intensity above 65% of maximum HR. To assess the metabolic risk markers, analyzes of total~     cholesterol, HDL-C fraction, LDL-c fraction, triglycerides, blood glucose, insulin, aspartate~     aminotransferase (AST) and alanine aminotransferase (ALT) were conducted in T0 and T1.~     Physical activity (PA) was assessed by accelerometry (Actigraph, GT3-X model, Florida) for 10~     consecutive days. The health related PF components were evaluated throw different tests 20m~     Shuttle-run Test; handgrip dynamometry (TKK 5101 tightening D; Tokyo Japan); standing feet~     jump Test; Abdominal Test; trunk extension test; and body mass index (BMI) was calculated.~     Motor fitness was assessed by coordinations Test für Kinder - KTK. To assess food~     consumption, a 24-hour recall was held. For statistical analysis, the t-Student test and~     General Linear Model (GLM) - ANCOVA for repeated measures test with post-hoc Bonferroni (p~     <0.05) were performed. Multilinear regressions were done to analyse associations between~     measured outcomes.~   "
48702|NCT02929459|"~     The purpose of this trial is to investigate comprehensively the effect of riboflavin~     supplementation on the abundance of F. prausnitzii and on other members of the gut microbiota~     in faeces of healthy volunteers. Additionally it will be assessed whether riboflavin~     supplementation affects the abundance of potentially pathogenic bacteria such as adherent~     invasive E. coli (AIEC). Finally, the effect of riboflavin supplementation on the production~     of Short Chain Fatty Acids, the release of gut hormones and potential changes in glucose~     homeostasis and appetite perception will be assessed.~   "
48703|NCT02929446|"~     Advances in surgical technique have led to a more complex surgery on patients with more~     serious comorbidities and the risk of postoperative pulmonary complications (PPC) such as~     pneumonia, and respiratory insufficiency, is considerable . The isolated effect of~     mobilization immediately after surgery has previously not been studied. The aim of the study~     is to evaluate the effects of immediate mobilization (within 2 hours) after abdominal~     surgery.~      Methods~      A randomized controlled trial will be conducted . A total of 200 Swedish-speaking, adult~     patients (≥18 years) planned for elective open abdominal surgery with surgery time exceeding~     2 hours are eligible for consecutive enrollment in the study. Patients who cannot walk~     independently will be excluded. Procedure: Patients will be randomized to either:~        1. Mobilization within 2 hours after surgery - sitting 1-3 hours in a chair interspaced by~          1 hour bedrest during the day of surgery or to~        2. Mobilization within 2 hours after surgery - sitting 1-3 hours in a chair interspaced by~          1 hour bedrest during the day of surgery + breathing exercises with PEP or to~        3. No mobilization - that is laying or sitting in bed with a maximum of 30° elevation of~          the head rest. No mobilization out of the bed until after 4 hours.~      Outcome assessment The primary outcome is occurrence of respiratory insufficiency defined as~     arterial oxygen pressure (PaO2) <8 kilo pascal (kPa) measured via arterial blood gas sample,~     or peripheral oxygen saturation (SpO2) <90%, measured peripherally with a pulse oximeter.~     Secondary outcomes are changes in arterial carbon dioxide pressure (PaO2), arterial oxygen~     pressure/fraction inspired oxygen (PaO2/FiO2) (arterial blood gas sample) over time and~     between groups; lung function assessed as inspiratory vital capacity (IVC), forced vital~     capacity (FVC), forced expiratory flow in the one second (FEV1) and peak expiratory flow~     (PEF) by a micro spirometer; number of patients with respiratory insufficiency, defined as~     SpO2 <90%, or PaO2 <8kPa and/or PaCO2 ≥6.5 kPa measured without oxygen supply ; postoperative~     pneumonia and total length of stay at the wards and at the hospital.~      Clinical significance If a fairly simple and cheap intervention, such as mobilization~     immediately after open abdominal surgery, can lead to less postoperative complications,~     shortened stay at hospital in total, it should be included as a routine in postoperative~     care.~   "
48704|NCT02929433|"~     The cycloergometer is a mechanical device consisting of a bicycle frame fixed on a support~     base, designed to measure the amount of muscle work performed during exercise and the~     resistance to pedaling. The cycloergometer has been already employed in many fields of~     medicine.~      However, up to date, a little use of cycloergometer in the management of chronic joint~     diseases has been documented and scientific studies have not clarified if cycloergometer is~     effective in these diseases and, particularly, in Rotator Cuff Tear patients.~   "
48705|NCT02929420|"~     The purpose of this study is to evaluate the efficacy and safety of Xiaoru Sanjie capsule in~     the treatment of cyclomastopathy.~   "
48706|NCT02929407|"~     The purpose of this trial is to investigate safety, tolerability, pharmacodynamics, and~     pharmacokinetics after intravenous administration of FE 204205 in patients with cirrhotic~     portal hypertension.~   "
48707|NCT02929394|"~     Maintenance therapy with trabectedin versus observation after first line treatment with~     doxorubicin of patients with advanced or metastatic soft tissue sarcoma.~      This is a prospective, multicenter, randomized, open label Phase III trial investigating~     whether a maintenance treatment with trabectedin, as compared to the observational approach,~     can prolong progression-free survival in patients with advanced, inoperable and/or metastatic~     STS after response or stabilisation during first line treatment with doxorubicin.~   "
48708|NCT02929381|"~     The aim of the study is to evaluate the usefulness of high-tech endoscopy in clinical~     practice.~      The important elements of this evaluation are:~        -  Evaluation of the character of neoplastic lesions in the colon based on different~          imaging techniques~        -  Verification of the endoscopic image with histopathologic descriptions~        -  Establishing the type of the lesion on the basis of Kudo and NICE classifications~        -  Comparison of the result of histopathological examination with the macroscopic type of~          the lesion~        -  Determination of the most advanced lesions (MAL)~        -  Comparison of the cecal intubation time~        -  Evaluation of the type of anesthesia used during colonoscopy~        -  Subjective assessment of the severity of pain according to VAS (visual analogue scale)~        -  Comparison of the accuracy of the location of lesions on the basis of endoscopic~          navigation~        -  Comparison of the total examination time~        -  Comparison of adenoma detection rate~   "
48709|NCT02929368|"~     Peripherally inserted central catheters, or PICC lines, has now been successfully in use for~     many years, especially in the chemotherapeutic treatment of oncologic patients or in~     parenertal nutrition. The implantation of PICC lines is mostly performed under x-ray~     (fluoroscopy). The aim of the clinical study is to assess the safety and the efficacy of the~     SHERLOCK-Systems eliminating the confirmatory chest x-ray exposure. Additionally, the~     SHERLOCK-System immediately confirms the PICC tip position even at the bedside of the~     patient, thus, saving costs and time.~   "
48725|NCT02929160|"~     Randomized control trial to compare the efficacy and safety of percutaneous nephrostomy with~     retrograde ureteric stenting for emergency renal decompression in cases of obstruction and~     sepsis associated with ureteric calculi.~   "
48713|NCT02929316|"~     Celiac disease (CD) is characterized as an autoimmune disorder whereby gluten (a protein~     found in wheat, barley, rye, malt) induces an immunological response in genetically~     susceptible individuals. The prevalence of CD has been estimated to affect 0.5-1% of the~     population worldwide. Long term sequelae are numerous and include risk of lymphoma,~     malabsorption leading to weight loss, anemia, multiple vitamin deficiencies,~     osteoporosis/osteopenia, secondary autoimmunity, etc. (1)~   "
48714|NCT02929303|"~     This is an expanded access protocol for use of intravenous fish oil infusion, Omegaven, in~     infants and children with parenteral nutrition associated liver disease (PNALD) to decrease~     elevated liver enzymes and direct bilirubin.~      This study aims to describe the response of PNALD after use of Omegaven by normalization of~     serum levels of liver enzymes and bilirubin.~   "
48715|NCT02929290|"~     The main objective of this study is to evaluate the safety, tolerability, efficacy and~     pharmacokinetics of BPI-9016M in patients with c-Met-dysregulated advanced NSCLC.Biomarkers~     related to the efficacy of BPI-9016M will be investigated.~   "
48716|NCT02929277|"~     PASTURE is a birth cohort of children born to farm and non-farm women from rural areas across~     Europe. Five study centres Austria, Germany, Switzerland, France and Finland enrolled 1133~     children (farmers in about half of the children) to study the origins of asthma and atopy and~     to develop potential preventive strategies.~      Previous results show a protective effect of farm exposure on allergic risk by livestock~     contacts and microbial exposures and by raw cow milk consumption in early age.~      PASTURE Part IV is the 10-year follow up of this birth cohort. The primary objective is to~     characterize the allergic phenotype between 6 and 10 years old (asthma and allergic rhinitis)~     and to explain how early age exposures and particularly milk products consumption contribute~     in the process of allergic illness in childhood. A focus on the characterization of the~     protective biologically active components in raw milk and identification of immunological~     mechanisms are involved.~   "
48717|NCT02929264|"~     An fMRI study in healthy volunteers to investigate the effects of ABX-1431 on experimental~     hyperalgesia and its neural correlates.~   "
48718|NCT02929251|"~     RUBI, is the first prospective randomized, head to head study, comparing Adalimumab to either~     anakinra, or tocilizumab in refractory Non Infectious Uveitis (NIU). There is no firm~     evidence or randomized controlled trials directly addressing the best biologic agent in~     severe and refractory NIU. NIU can cause devastating visual loss and up to 20% of legal~     blindness. Corticosteroids and immunosuppressants failed to demonstrate sustainable remission~     over 70 % of refractory/relapsing severe uveitis. The incidence of blindness in NIU has been~     dramatically reduced in the recent years with the use of biologics, raising the question of~     whether these compounds should be used earlier in the treatment of severe non infectious~     uveitis. Contrasting with immunosuppressors, biotherapies act rapidly and are highly~     effective in steroid's sparing thus preventing occurrence of cataract and/or glaucoma.~      Despite a strong rationale, these compounds are not yet approved in uveitis, which guarantees~     the innovative nature of this study that aims selecting or dropping any arm when evidence of~     efficacy already exists.~   "
48719|NCT02929238|"~     You are being asked to participate in this study because you have a complex wound that~     requires treatment with negative pressure wound therapy (NPWT). NPWT is a therapeutic~     technique which involves the placement of a wound vacuum at the site of the wound. The wound~     vacuum delivers a negative pressure at the wound site through a dressing. Any fluid collected~     during this process is collected through a foam (sponge) underneath the dressing. This~     therapy helps to draw the edges of the wound together, while removing infectious material, to~     help promote healthy tissue growth and speed up wound healing. The purpose of this study is~     to determine if placing polypropylene suture (a material normally used to close wounds)~     between the wound and the NPWT foam would decrease pain upon removal of the sponge while~     allowing adequate healing of the wound.~   "
48720|NCT02929225|"~     Intestinal microbiota has recently emerged as an important player in the progression and~     complications of chronic kidney disease(CKD). And drug therapy which selects the gut as a~     target has raised lots of concern. It has been reported that the composition of intestinal~     flora has changed in uremic patients. Specifically, imbalanced ecosystem has higher number of~     pathogens such as Clostridia, Enterobacteria,and lower number of beneficial microbes such as~     Lactobacilli and Bifidobacteria. This modification of intestinal flora can strongly increase~     transformation of amino acids into Uremic Retention solutes, e.g., indoxyl-sulfate (IS),~     p-cresyl sulfate (PCS), which are so called gut-derived uremic toxins. The dysbiosis also~     contributes to an increase in intestinal permeability by disrupting the colonic epithelial~     tight junction,which may subsequently lead to translocation of endotoxin and bacteria into~     the host's internal environment,resulting in systemic micro-inflammation.Also all of these~     can promote the progression of renal failure and the incidence of cardiovascular~     complications,renal osteodystrophy and anemia.Probiotics is defined by the World Health~     Organization as 'live microorganisms that, when administered in adequate amounts, confer a~     health benefit on the host'. Probiotics are being increasingly used for various pathologic~     conditions.It is said that probiotics have a therapeutic role in maintaining a metabolically~     balanced gastrointestinal tract (GIT).And in our previous study,the investigators found that~     in uremic rats,lactobacillus acidophilus can relieve bacterial translocation and decrease the~     level of inflammatory markers.So our study is mainly designed to investigate whether~     probiotics can modulate the balance of intestinal ecosystem, prevent the bacterial~     translocation from gut and alleviate the systemic inflammation in hemodialysis(HD) patients.~   "
48721|NCT02929212|"~     The purpose of this study is to determine the effect of meal size and texture on the levels~     of incretin hormone, GLP-1, after Gastric Bypass Surgery (GBP). Patterns of food intake~     change after bariatric surgery and patients often eat multiple small low-calorie meals, a~     pattern that may affect blood glucose as well as incretin levels. Whether the release of~     GLP-1 after an oral challenge or a single liquid meal has any physiological relevance in~     'real life' setting of multiple small meals diet is unclear.~   "
48722|NCT02929199|"~     The aim of this study compare soft tissue reaction (bleeding, gingival color and texture),~     bacteria type and count in the gingival sulcus around the restoration margin and sulcus depth~     of Bio-compatible High performance polymer( Bio-Hpp) restorations to E-max regardless its~     popularity in the dental field.~   "
48723|NCT02929186|"~     This is a randomized controlled pilot study aimed at testing different outreach strategies~     (opt-in versus opt-out) to increase colorectal cancer screening through completion of mailed~     home fecal immunohistochemical testing (FIT).~   "
48724|NCT02929173|"~     The aim of this study is to compare the patient satisfaction and clinical assessment (shade~     matching, surface texture and marginal discoloration) of Bio- High Performance Polymers (HPP)~     restoration versus E-max restoration compared to contralateral tooth in anterior zone.~      Regardless E-max popularity in the dental field.~   "
48726|NCT02929147|"~     An optimal analgesic therapy is very important for postoperative recovery. In recent years,~     several studies showed that the prevalence of the moderate to severe pain after craniotomy~     ranged from 69 to 87% of patients. In a previous study, the investigators showed that the use~     of morphine based patient controlled analgesia prevented moderate to severe postoperative~     pain in patients undergoing supratentorial craniotomy. Morphine related side effects such as~     sedation, miosis, respiratory depression, nausea and vomiting produce a general reluctance~     for their use in neurosurgery. Therefore, all patients were closely observed to detect opioid~     related side effects in the intensive care unit for 24 hours following surgery in the~     previous study. The Integrated Pulmonary Index (IPI) is a new tool that calculates~     respiratory and hemodynamic parameters noninvasively. In the present study the investigators~     will use different doses of morphine based PCA and the IPI system to determine more effective~     and safer morphine dose for postoperative analgesia following supratentorial craniotomy.~   "
48727|NCT02929134|"~     Current lymphedema management protocols are based on the use of simple measures of hygiene~     (regular washing with soap and water, skin and nail care), use of topical antibiotics or~     antifungal agents, exercise and footwear. This is considered the standard of care in most~     endemic countries in the absence of any structured treatment programs. Previous controlled~     clinical trials and extensive field experience have shown the benefit of these measures in~     reducing the frequency of attacks of acute dermato-lymphangio-adenitis (ADLA) that drive the~     progression of lymphedema.~      In the present study, the progression of lymphedema in a group of patients who receive a~     six-week course of doxycycline will be compared with that of a group who receives doxycycline~     look-alike placebo tablets. However, both groups will be enrolled into a standardized~     regimen of hygiene described above. Thus, patients enrolled in the placebo group also~     will receive the current standard of care, and the placebo used in the study will help to~     identify the benefits of doxycycline on a background of simple hygiene measures. The regimens~     will be explained to all participants who will be trained to use established standardized~     methods of hygiene and be effectively applying it prior to the initiation of the drug~     treatment. In addition, patients will be evaluated at 3, 6, 12 and 24 months.. A common,~     generic SOP with handouts that describes methods and the training schedule will be used so~     that similar methods are employed across all sites.~   "
48728|NCT02929121|"~     Current lymphedema management protocols are based on the use of simple measures of hygiene~     (regular washing with soap and water, skin and nail care), use of topical antibiotics or~     antifungal agents, exercise and footwear. This is considered the standard of care in most~     endemic countries in the absence of any structured treatment programs. Previous controlled~     clinical trials and extensive field experience have shown the benefit of these measures in~     reducing the frequency of attacks of acute dermato-lymphangio-adenitis (ADLA) that drive the~     progression of lymphedema.~      In the present study, the progression of lymphedema in a group of patients who receive a~     six-week course of doxycycline will be compared with that of a group who receives doxycycline~     look-alike placebo tablets. However, both groups will be enrolled into a standardized~     regimen of hygiene described above. Thus, patients enrolled in the placebo group also~     will receive the current standard of care, and the placebo used in the study will help to~     identify the benefits of doxycycline on a background of simple hygiene measures. The regimens~     will be explained to all participants who will be trained to use established standardized~     methods of hygiene and be effectively applying it prior to the initiation of the drug~     treatment. In addition, patients will be evaluated at 3, 6, 12 and 24 months.. A common,~     generic SOP with handouts that describes methods and the training schedule will be used so~     that similar methods are employed across all sites.~   "
48729|NCT02929108|"~     The project will test the effect of educating and supporting caregivers of hospice cancer~     patients on their active participation in shared decision making in the plan of care for~     their patients.~   "
48730|NCT02929095|"~     Percutaneous trans-arterial angioplasty(PTA) is one of the peripheral arterial occlusive~     disease(PAOD) treatment. During and after PTA, ischemia-reperfusion pain is induced so proper~     analgesia is important. ischemia-reperfusion injury is due to reactive oxygen species.~     Dexmedetomidine has analgesic, sedative and anti oxidant effect. So the investigators~     research the patient's satisfaction that are given the dexmedetomidine during PTA procedure.~   "
48731|NCT02929082|"~     FORCE project aims to measure actives forces of malignant tumor by magnetic resonance force~     (FRM). Two main forces are considered as key indicators of therapeutic response and~     metastatic potential: interstitial force and traction force at the interface cell/tumor.~     Biomarkers of these forces will be developped using direct images of magnetic resonance force~     (FRM). Efficiency of these non-invasive biomarkers will be evaluated through their capacity~     to predict tumoral environment invasion, notably micro-vascular invasion, and therapeutical~     results in Hepatocellular Cancer (HCC).~      Principal criteria will be~        1. micro-vascular invasion assessed by pathological examination of surgical pieces (gold~          standard).~        2. interstitial force and traction force at the cell/tumor interface assessed by FRM.~      Population of patients will be divided in three groups. A first group will be constituted of~     20 volunteer patients coming for abdominal MRI with no known hepatic disease, in order to~     determine the feasibility of FRM. A second group will be constituted of 60 patients with~     resectable HCC eligible for surgery. This group will enable to evaluate the tumoral~     environment invasion. Third group will be constituted of 50 patients with HCC eligible for~     transplant with transcatheter arterial chemoembolization (TACE) treatment as pending~     treatment before transplant. This groups will enable to evaluate the efficiency of TACE~     through the necrosis percentage in treated HCC.~      Inclusion of patients will occur during 24 months for a total study duration of 36 months.~      All patients will have MRI as usual care. FRM is performed during MRI with the use of a~     specific medical device and therefore corresponds to an additional procedure of the research.~      Moreover, patients in group 2 and 3 will be asked to participate to an ancillary study~     consisting in circulating tumoral cells (CTC) measurement. If they accept, a blood sample~     will be collected just before the MRI in order to evaluate the correlation between CTC and~     micro-vascular invasion.~   "
48732|NCT02929069|"~     The intent of the proposed randomized controlled trial is to test the efficacy of a~     principle-based, transdiagnostic cognitive behavioral therapy (CBT) intervention that~     addresses the pathways through which minority stress compromises young gay and bisexual men's~     (YGBM) co-occurring mental (e.g., depression), behavioral (e.g., substance use), and sexual~     (e.g., condomless anal sex) health problems.~   "
48733|NCT02929056|"~     The purpose of this study is to evaluate and compare healing characteristics, reduction in~     the size of the wound and to measure complete healing of the wound following the application~     of a biologic product dressing instead of the alginate dressing along with standard~     debridement and compression therapy versus the standard of care treatment for VLUs. The~     biologic product that will be used in this study is called AmnioExCel™.~   "
48734|NCT02929043|"~     Up to date, devices capable of delivering controlled, calibrated, non-contact cold air~     stimuli in a MR environment are unavailable for quantitative sensory testing. This project~     therefore aimed at designing and constructing a novel MR-compatible, computer-controlled cold~     air stimulation device that produces air puffs in a broad flow and cold temperature range. By~     means of this device, detailed psychophysically testing and subsequent brain scanning of~     dentine hypersensitivity (DH) subjects will be possible to gain new insights about DH~     mechanisms.~   "
48735|NCT02929030|"~     The study aims to evaluate the safety and efficacy of polymer-free sirolimus-eluting coronary~     stent system (NANO plus) in patients with coronary artery disease . The primary endpoint is~     target lesion failure, a composite endpoint of cardiac death, target vessel related~     myocardial infarction and clinically-driven target lesion revascularization at 1 year~     follow-up.~   "
48736|NCT02929017|"~     Patients with Idiopathic Pulmonary Fibrosis (IPF) and their caregivers will be randomized to~     receive this intervention or usual care. The intervention will include information about the~     disease, self-management strategies, and introduction to advanced care planning in a format~     with enhanced content available across multiple domains (face-to-face, printed material,~     digital (tablet) delivered by an interventionist. The usual care group will be provided with~     routine printed patient education.~      At the end of life, IPF patients and their caregivers experience stress, symptom burden, poor~     quality of life, and inadequate preparedness for end-of-life care planning. The proposed~     study will measure feasibility, acceptability, and impact of a Supportive Care intervention.~   "
48737|NCT02929004|"~     These last years, it has been proven that the solicitation of a muscle using vibration may~     lead to positive effects on the neuromuscular function. Thus, the aim of the current study is~     to assess if the addition of local vibration training sessions on the quadriceps muscle to~     the classic readaptation program (i.e. physiotherapist sessions) may allow a better~     recuperation 2 months after the surgery and the reconstruction of the anterior cruciate~     ligament.~      The aim of the vibration training proposed in the current study is to allow a better~     recuperation 2 months after the anterior cruciate ligament reconstruction when compared with~     conventional physiotherapy alone.~   "
48738|NCT02928991|"~     This is a pilot study to determine whether fludarabine-based reduced intensity conditioning~     (RIC) regimens facilitate successful donor engraftment of patients with acquired aplastic~     anemia (AA) and Inherited bone marrow failure (iBMF) syndromes undergoing Matched related~     donor bone marrow transplant (MRD-BMT).~   "
48739|NCT02928978|"~     This study is evaluating how ruxolitinib affects premalignant breast cells. One half of the~     study participants will receive ruxolitinib for approximately 15 days, and the other half~     will receive a placebo (sugar pill) for approximately 15 days. Once study participants have~     completed their ruxolitinib or placebo, participants will undergo surgery to remove the~     premalignant breast tissue.~   "
48740|NCT02928965|"~     The purpose of this study is to investigate if minocycline limits the development of negative~     symptoms in early psychosis and to test via what mechanism of action this change occurs.~   "
48741|NCT02928952|"~     The purpose of this study is to see if adding Mindfulness training to diabetes education~     reduces feelings of stress and makes it easier to adhere to healthy behaviors that improve~     diabetes outcomes (such as hemoglobin A1c).~   "
48742|NCT02928939|"~     Clinical practice guidelines do not take into account multimorbidity and various potential~     therapeutic conflicts. Identifying and quantifying therapeutic conflicts is crucial in~     multimorbid patients having more than two acute or chronic diseases. Guidance should be~     available for frequent encountered situations, e.g. gastrointestinal bleeding or exacerbation~     of diabetes mellitus.~   "
48743|NCT02928926|"~     Cerebral autoregulation is an important mechanism whereby cerebral perfusion is normally~     maintained at a constant level, over a relatively wide blood pressure range. It can be~     assessed noninvasively by the use of Trans Cranial Doppler (TCD). This means using ultrasound~     probes over both sides of the head to measure changes in blood flow in one of the main brain~     arteries (the middle cerebral artery) in response to beat to beat changes in blood pressure~     dynamic cerebral autoregulation (dCA). It is established that dCA is impaired following~     moderate to severe stroke, acting as a key role in the development of secondary brain damage~     related to brain swelling and further damage related to low blood flow. The administration of~     clotbusting therapy (thrombolysis), one of the main approved treatments of acute ischaemic~     stroke (AIS), results in recanalization of the blocked artery in over approximately 50%~     patients. However, due to its clot dissolving property, it may increase the risk of bleeding~     in the body, especially in the brain, leading to greater disability or even death. To date,~     there has been very little information regarding the natural history and prognostic~     significance of impaired Cerebral Autoregulation during and following reperfusion, especially~     those who receive thrombolysis. This research will use the noninvasive technique of Trans~     Cranial Doppler (TCD) to see how blood flow changes in AIS patient at the initiation and~     completion of thrombolysis, and during acute, subacute and chronic phase post stroke onset,~     compared with those AIS patient who did not receive thrombolysis. This study will provide~     important data regarding perithrombolysis blood pressure management, an important and common~     clinical dilemma~   "
48744|NCT02928913|"~     To investigate associations between sedentary and active behaviour with bone health and~     functional ability, and to associate mechanical loading at the lumbar spine and hip in~     sedentary and active individuals with bone mineral density.~   "
48745|NCT02928900|"~     The goal of this study is to develop and evaluate a clinical training intervention utilizing~     standardized patient actors to improve communication and interpersonal skills of health care~     workers who serve HIV-infected adolescents and youth in Kenya, resulting in increased~     engagement in HIV care. The effect of the intervention on retention in care will be evaluated~     in a stepped-wedge randomized controlled trial at 24 HIV care and treatment facilities.~   "
48746|NCT02928887|"~     The goal of this study is to determine whether or not exposure to blue spectrum light reduces~     acute kidney injury and systemic inflammation in subjects undergoing cardiopulmonary bypass.~     Subjects scheduled to undergo cardiopulmonary bypass surgery will be exposed to either bright~     (1000 lux) blue spectrum (480nm) light or to ambient, white fluorescent light for a 24 hour~     photoperiod the day prior to surgery and for a 24 hour photoperiod in the immediate~     postoperative period.~   "
48747|NCT02928874|"~     Using an integrated approach, this study examines multiple eating traits concurrently under~     states of hunger and satiety. It examines the impact of short-term appetite and intake~     regulation on longer-term energy intake control and weight development in a cohort of~     ethnically diverse normal-weight and obese boys and girls with different familial~     predispositions to obesity.~   "
48748|NCT02928861|"~     The purpose of this study is to evaluate whether 18F-FDG PET/CT-based prognostic model of~     diffuse large B-cell lymphoma can predict disease progression~   "
48749|NCT02928848|"~     In the present sham-controlled study, the investigators examine whether tDCS could be used to~     enhance language abilities (e.g., picture naming) in individuals with PPA variants primarily~     characterized by difficulties with speech production (non-fluent and logopenic).~   "
48750|NCT02928835|"~     To evaluate the effects of a knee flexion Dynasplint orthosis on knee flexion angle after a~     total knee arthroplasty. Sixty participants, who underwent a total knee arthroplasty, were~     randomly assigned in two groups: control group and Dynasplint group.~   "
48751|NCT02928822|"~     The purpose of this study is to determine whether VR based language rehabilitation scenario~     based on the core premises of ILAT has a beneficial effect on the linguistic performance~     (faster retrieval of the target lexicon and general fluency) of Broca's aphasia patients.~     Furthermore, it aims at testing the effects of cueing (visual and auditory) on word~     retrieval.~   "
48752|NCT02928809|"~     The objective of this study is to perform an evaluation of the effect of LLLT on the~     prevention of fatigue in the masseter and anterior temporal muscles in young individuals with~     and without TMD.~   "
48753|NCT02928796|"~     Uncovering the distinct measurements and features that potentially exist in different levels~     of expertise when performing cardiology-based procedures. There is a belief that tracking the~     visual attention and other psychophysiological measures during performance of these~     procedures may assist in uncovering the attentional capacity of participants and how it links~     with overall performance.~   "
48754|NCT02928783|"~     Home-based rehabilitation programs have not been widely few been studied and the training~     effects are not unclear. This study evaluates the beneﬁcial effects of home-based cardiac~     rehabilitation on quality of medical care in patients with chronic heart failure.~   "
48755|NCT02928770|"~     The purpose of this research study is to test a new approach for treating patients with~     obstructive sleep apnea and/or snoring. The new nasal device, nastent (NAS: nasal airway~     stent), appears to be a useful alternative or additive treatment.~   "
48756|NCT02928757|"~     There are ~6,200 children in Ontario with special and complex healthcare needs requiring~     multiple services from many different doctors and other healthcare providers. These children~     are at a high risk of missed, duplicated or inappropriate care, and extraordinary financial~     burden and stress on families. While small in number (<1% of Ontario kids), these children~     use 1/3 of all child healthcare resources, and are known to desperately need coordinated care~     to optimize their health. Complex Care Kids Ontario (CCKO) brings together researchers,~     children and families, and healthcare providers from across Ontario to develop, implement and~     evaluate an evidence-based and coordinated model of care for every child with medical~     complexity in Ontario.~   "
48757|NCT02928744|"~     Limitation of expiratory flows is considered as the main determiner of dynamic distension and~     dyspnoea in chronic obstructive pulmonary disease (COPD). The analysis of proximal and distal~     resistances should allow to better appreciate the functional impact.~      This study should also allow to specify the best parameters in respiratory functional~     explorations useful for the follow-up in COPD and to specify the relevance of functional~     indications other than the forced expiration volume at 1 second (FEV1) or the functional~     residual capacity (FRC) to estimate in a more relevant way the clinical improve with the~     increase of the therapeutic load (increase of posology, association of two bronchodilatators,~     addition of an anti-inflammatory drug, thus etc…) at already handled patients suffering from~     a persistent dyspnoea insufficiently relieved.~   "
48758|NCT02928731|"~     The aim of this study is to explore the impact of cancer and therapy-related symptoms on~     Mainland Chinese children's physical and psychological well-being.~   "
48759|NCT02928718|"~     Pancreatitis remains the most common complication of ERCP, with the reported incidence~     ranging from 2% to 9%. Although 80% of cases are mild, a significant number of patients may~     develop severe pancreatitis, that means additional morbidity and risk for death. ERCP,~     despite the development of new diagnostic tools, remains a widely used procedure, so~     post-ERCP pancreatitis is a problem with significant impact. Several studies and~     meta-analyses helped us to recognize special factors that put an individual in high risk for~     the development of post-ERCP pancreatitis. Among these factors special interest presents the~     history of post-ERCP pancreatitis as an independent risk factor for a new episode of~     post-ERCP pancreatitis. It seems that some individuals have a genetically predisposed~     susceptibility in this particular complication. The aim of the present study is to~     investigate the possible genetic variation associated with post-ERCP pancreatitis using whole~     genome sequencing.~   "
48760|NCT02928705|"~     The purpose of this retrospective study is to analyze quality and adverse events of analgesia~     by telemedically supported paramedics in comparison to conventional treatment by on-scene~     emergency medical service (EMS) physicians in the EMS of the city of Aachen, Germany.~   "
48761|NCT02928692|"~     Postoperative cognitive dysfunction (POCD) and postoperative delirium occurs mainly in aged~     patients. POCD and POD may increase the mortality and morbidity. However, the mechanism of~     POCD is not clear yet and no effective therapy method was proved. According to previous~     study, the neuroinflammation is the main reason both for POCD and POD. Minocycline is a~     tetracycline derivative. Due to it's lipophilic structure, it is easy to pass through blood~     brain barrier and attenuate neuroinflammation. It's neuroprotective effects has been proven~     in many experimental animal models such as Alzheimer's disease, Huntington's disease and~     Parkinson's syndrome. In present study, the investigators hypothesized that minocycline would~     attenuate the incidence of POCD and POD in the aged patients.~   "
48831|NCT02927769|"~     The purpose of this study is to determine whether nivolumab plus brentuximab vedotin~     (followed by brentuximab vedotin plus bendamustine in patient with suboptimal response) is~     safe and effective in treating patients with Hodgkin's lymphoma (cHL). Eligible patients are~     children, adolescents, and young adults relapsed or refractory to first line.~   "
48762|NCT02928679|"~     This is a substudy to a randomised trial investigating the effect of liraglutide on body~     weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864). In~     the parent trial, patients will be subjected to an 8-week diet intervention phase including a~     low-calorie diet and dietetic counseling, after which patients will be randomised to receive~     either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on~     re-introducing regular foods and a focus on continued motivation to engage in a healthy~     lifestyle.~      This substudy aims to investigate the impact of, and subsequent change of, joint~     inflammation, articular cartilage composition, overall knee morphology, and clinical~     symptoms, in obese patients with knee osteoarthritis following a randomisation to Liraglutide~     3 mg or Liraglutide 3 mg placebo treatment between weeks 0-52.~   "
48763|NCT02928666|"~     Introduction: in the course of the research, the investigators will develop a~     decision-support system (comorbidity-DSS) consisting (1) a knowledge base (KB) consisting of~     (a) computer-interpretable clinical guidelines for type 2 diabetes and 2 other diseases from:~     obstructive pulmonary disease, osteoporosis, hypertension, and osteoarthritis; and (b) an~     ontology of relevant general medical knowledge that could complement (a) in order to propose~     non conflicting treatment options not mentioned in the clinical practice guidelines; and (2)~     an algorithm that matches the KB with a patient's data set to identify the guidelines-based~     recommendations applicable for the patient and their interactions and which proposes ways to~     mitigate conflicting interactions (e.g., suggesting to select intervention A.2 (instead of~     A.1) from guideline A and intervention B.3 (instead of B.1) from guideline B together with an~     action B' mentioned in the general medical knowledge, because these interventions are not~     conflicting yet A.3 fulfills the same goals as intervention A.1 and intervention B.3 + B'~     together fulfill the same goal as B.1).~      Research purpose: Assessing the correctness and completeness of detection of~     recommendation-interaction and generation of conflict-free recommendations by a~     comorbidity-DSS~      Research question: How will the usage of the comorbidity-DSS affect the completeness and~     correctness of clinicians regarding (a) detection of interactions between recommendations~     originating from different clinical guidelines applicable for patients with comorbidities and~     (b) identification of interventions that fulfill the guidelines' goals and are not~     conflicting.~   "
48764|NCT02928653|"~     The aim of this study will be to compare the effects of daily consumption of aspartame,~     rebaudioside a, saccharin, sucralose, and sucrose on body weight and composition in a~     standardized protocol. The investigators hypothesize that individual low calorie sweeteners~     (consumed in a beverage) differ from each other in promoting weight loss and decreased fat~     mass (without energy restriction or dietary guidance) based on their chemical structure.~   "
48765|NCT02928640|"~     The purpose of the study is to collect information on prostrate biopsy tissue for use in~     developing a method determining the difference in normal and cancerous prostrate tissue using~     the ClariCore System.~   "
48766|NCT02928627|"~     Hepatocellular carcinoma (HCC) is the most frequent primary tumour of the liver and is the~     third cause of cancer-related mortality worldwide. Depending on the stage of the disease, the~     treatment options are surgery, liver transplantation, chemotherapy or radiotherapy.~      Recently, scientific research has focused on small molecules called microRNAs which are~     produced by human cells and can be released in the blood. They have a role in cell~     proliferation and are found to be dysregulated in different types of cancer.~      It has been shown that microRNAs have a role in the development of HCC but it is unknown if~     these molecules can be used as markers for diagnosis and survival in HCC.~      In particular, microRNAs miR-221 and miR-222 are dysregulated in the tumoral tissues in about~     80% of patients with HCC. This can be assessed on tissues from liver biopsies or surgical~     specimens, both invasive approaches. Only few studies showed the presence of microRNAs in the~     blood of patients with HCC but it is unknown if there is a correlation between tumoral tissue~     expression and circulating levels.~      The aim of this study is to evaluate if these two microRNAs are expressed not only in the~     tumoral tissues but also in the blood from cancer patients, and in different amounts compared~     to circulating levels in healthy individuals. A correlation between tumoral tissue and blood~     levels will also be evaluated.~      Should this evaluation show a strong correlation and reliability of circulating microRNAs in~     the diagnosis and follow up of HCC, future clinical trials targeting these microRNAs and~     their related pathways might benefit from this being adopted as conventional practice instead~     of the need of assessing tissue levels from liver biopsies.~      The results of this pilot study will bring preliminary results as a first step for future~     analysis on a larger cohort of patients.~   "
48767|NCT02928614|"~     This is a substudy to a randomized trial investigating the effect of liraglutide on body~     weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864). In~     the parent trial, patients will be subjected to an 8-week diet intervention phase including a~     low-calorie diet and dietetic counseling, after which they will be randomized to receive~     either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on~     re-introducing regular foods and a focus on continued motivation to engage in a healthy~     lifestyle.~      This substudy aims to investigate the impact of, and subsequent change of biomarkers in obese~     patients with knee osteoarthritis following a randomization to Liraglutide 3 mg or~     Liraglutide 3 mg placebo treatment between weeks 0-52.~   "
48768|NCT02928601|"~     This study evaluates the effect of prophylactic ondansetron on the incidence of spinal~     hypotension and vasopressor consumption in caesarean section patients using norepinephrine~     treatment. Half of participants receive ondansetron before spinal anesthesia while the other~     half receive saline.~   "
48769|NCT02928575|"~     The purpose of this study is to determine whether a combination of Sunitinib, Temozolomide~     and Radiation Therapy would be effective in the treatment of newly diagnosed Glioblastoma~     patients harboring tumors with unmethylated MGMT promoter.~   "
48794|NCT02928250|"~     Carnosine, a naturally-occurring dipeptide (β-alanyl-L-histidine) first described in 1900 by~     Gulewitsch and Amiradzibi, is found predominantly in post-mitotic tissues (e.g. brain and~     innervated muscle) of vertebrates . Carnosine is claimed to decrease oxygen free-radical~     mediated damage to cellular macromolecules either by chelating divalent cations or scavenging~     hydroxy radicals with its imidazole moiety. Free-radical damage is not the only process to~     affect the structure of proteins and nucleic acids.~      To the best of our knowledge, no previous study assessed the role of carnosine in diabetes~     associated complications in particular diabetic nephropathy and there is insufficient~     evidence to recommend its supplementation in those patients. Therefore, this study was~     undertaken to investigate the role of carnosine as an adjuvant therapy for diabetic~     nephropathy in children and adolescents with type 1 diabetes and assess its relation to~     microalbuminuria, tubulointerstitial damage marker, glycemic control and oxidative stress.~   "
48795|NCT02928237|"~     To evaluate the effect of transcranial direct current stimulation (tDCS) applied to the motor~     cortex to reduce chronic abdominal visceral pain in a group of participants with~     hepatocellular carcinoma~   "
48770|NCT02928562|"~     Rehabilitation after total knee arthroplasty (TKA) should consider control of postoperative~     pain and swelling, protection of the healing graft, restoration of full range of motion~     symmetric to the contralateral knee, strengthening of the muscles that stabilize the knee,~     hip, and trunk, enhancing neuromuscular control, and a gradual progression to functional~     activities that are required for return to the normal daily life. The effects of concomitant~     injuries and surgical procedures must also be considered in planning an individualized~     rehabilitation program. However, it is still unclear regarding the optimal exercise~     prescription after TKA. In the current study, the investigators plan to develop an exercise~     protocol and evaluate the result in a multidisciplinary approach, i.e. bone mineral density~     assessment. The exercise prescription consisted of cyclic exercise, aerobic exercise and~     resistant training exercise for first, second and third year, respectively. Cyclic exercise~     is advantaged safety and effectiveness of hydraulic resistance equipment, as well as the~     exercise can be quantitatively determined. Aerobic exercise is privileged by the~     cardiopulmonary endurance improvement, along with muscle strengthening in the associated~     muscle groups. Resistance exercise is specified for the indicated muscle groups, especially~     knee extensors, flexors, ankle plantar flexor and dorsi flexor in TKA reconstructed patients.~     The investigators hypothesis that using this cyclic exercise process can improve the body~     composition, muscle strength, bone mass density, level of oxidative damage indicators, gait~     performance, quality of life, knee joint range of motion, function of cardiopulmonary and~     fitness. This project will establish the scientific basis for rehabilitation protocol~     involving knee surgery.~   "
48771|NCT02928549|"~     The purpose of this study is to explore the experiences of Black women who receive care for~     ovarian cancer at Memorial Sloan Kettering Cancer Center, or MSK for short. The study~     consists of interviews with Black women who recently obtained some part of their ovarian~     cancer care at MSK.~   "
48772|NCT02928536|"~     Within the TackSHS project (H2020 project grant agreement No 681040), we will conduct a~     European cross-sectional study, aiming at i) estimating prevalence and investigating~     determinants of smoking, e-cigarette use and exposure to SHS and to e-cigarette aerosol; ii)~     analyzing the attitudes, perceptions and behaviours of the adult European population towards~     policies to limit SHS exposure; iii) comparing selected smoking-related data between TackSHS~     and a previously conducted pan-European survey; iv) assessing mortality and morbidity from~     selected respiratory and cardiovascular diseases attributable to SHS exposure among adults~     and children in Europe; v) quantifying the economic burden associated to the exposure to SHS~     and e-cigarette aerosol in Europe. Overall, approximately 12,000 individuals aged 15 years or~     over will be enrolled in 12 different European countries (BG, DE, ES, FR, GR, IE, IT, LV, PL,~     PT, RO, UK). Surveys will be representative of the country-specific population in terms of~     sex, age, and socio-economic characteristics.~   "
48773|NCT02928523|"~     The investigators propose to use autologous fecal microbiota transplantation (AFMT) to acute~     myeloid leukemia (AML) patients treated with intensive chemotherapy and antibiotics in order~     to restore the balance of their intestinal microbiome and thereby eradicate treatment-induced~     multidrug resistant bacteria (MDRB), infection-related complications, as well as sequelae to~     the gastrointestinal tract. Therefore, the investigators propose to perform a single-arm~     multicentre prospective fecal microbiota transplantation (FMT) trial in AML patients~     receiving intensive chemotherapy, and who are usually heavily treated with broad-spectrum~     antibiotics during aplasia that generate a profound status of dysbiosis. For this purpose, at~     the time of admission and AML diagnosis, patients will be requested to donate stools that~     will be comprehensively screened, and if deemed appropriate according to protocol criteria,~     conditioned and stored frozen until future processing and transplantation after aplasia~     completion.~   "
48774|NCT02928510|"~     This research trial studies the mechanisms of idelalisib-associated diarrhea in patients with~     chronic lymphocytic leukemia, indolent non-hodgkin lymphoma, or small lymphocytic lymphoma~     that has come back after a period of improvement. The cancer treatment drug idelalisib~     triggers diarrhea in some patients. Studying stool, blood, and tissue samples in the lab from~     patients who are given idelalisib may help doctors learn more about the side effects and may~     help to treat them in future patients.~   "
48775|NCT02928497|"~     The purpose of this study is to establish the safety and effectiveness of the WATCHMAN™ Left~     Atrial Appendage Closure (LAAC) Device, including the post-implant medication regimen, for~     subjects with non-valvular atrial fibrillation who are deemed not to be eligible for~     anti-coagulation therapy to reduce the risk of stroke.~   "
48776|NCT02928484|"~     The purpose of this pilot study is to evaluate whether a probiotic supplement improves~     gastrointestinal (GI) function.~   "
48777|NCT02928471|"~     This is a substudy to a randomised trial investigating the effect of liraglutide on body~     weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864). In~     the parent trial, patients will be subjected to an 8-week diet intervention phase including a~     low-calorie diet and dietetic counseling, after which. Patients will be randomised to receive~     either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on~     re-introducing regular foods and a focus on continued motivation to engage in a healthy~     lifestyle.~      This substudy aims to investigate any changes in MRI associated with the initial 8-week~     weight loss intervention, and the value of CT scans in predicting the effect of weight loss.~   "
48778|NCT02928458|"~     This research study is for patients with adhesive small bowel obstruction (ASBO). ASBO is a~     condition in which the small intestine gets blocked due to scars called adhesions. To see the~     blockage, a contrast agent is given and an x-ray is taken of the belly (abdomen). MD~     Gastroview and omnipaque are two contrast agents that may be given as part of your normal~     care for ASBO. This study hopes to see if one is better than the other.~   "
48779|NCT02928445|"~     This 6-month extension study will provide further information regarding the long-term safety~     and tolerability of intepirdine (RVT-101) in subjects with Dementia with Lewy bodies (DLB)~     who have participated in the double-blind, placebo-controlled, lead-in study RVT-101-2001.~   "
48780|NCT02928432|"~     Abiraterone acetate (AA) has shown a favourable impact in overall survival, administered with~     prednisone to decrease the adverse event related to CYP171A suppression.~      Our hypothesis is that the change of prednisone to dexamethasone in CRPC patients that~     progress biochemically to AA + prednisone can improve the number and the length of the~     responses, and also improve tolerance to treatment, decreasing the adverse events associated~     to a moderate dosage of steroids used chronically.~   "
48781|NCT02928419|"~     Myelodysplastic syndromes (MDS) prevail in elderly patients and are characterized by~     inefficient erythropoiesis and peripheral cytopenias. Supportive care still represents the~     main therapeutic option in most patients. Quality of life is deteriorated mostly by anemia~     and by limitations due to dependence on transfusions, thrombocytopenia, and neutropenia. The~     only treatment available for severe thrombocytopenia consists of PLT transfusions, mainly in~     the presence of bleeding.~      In patients with low and intermediate-1 risk MDS with an isolated deletion 5q cytogenetic~     abnormality, red blood cell (RBC) transfusion-dependence is a prevalent condition. For these~     latter patients reaching transfusion-dependence, lenalidomide, an immunomodulatory drug, has~     been approved by FDA and EMA. It has been shown that the drug induces significant erythroid~     (about 65%) and cytogenetic responses which have been associated with a survival benefit. In~     patients with MDS with del5q and serum erythropoietin levels > 500 miU/L, lenalidomide dosing~     of 10 mg/day for 21 days every 28, rather than 5 mg dosing, induces higher rates of~     transfusion-independence and cytogenetic responses with a trend to survival advantage. As a~     consequence, the recommended starting dose of lenalidomide is 10 mg orally once daily on days~     1-21 of repeated 28-day cycles. Lenalidomide treatment must not be started if the Absolute~     Neutrophil Counts (ANC) < 0.5 Gi/L and/or PLT counts < 25 Gi/L.~      For patients who are dosed initially at 10 mg and who experience thrombocytopenia < 25 Gi/L~     (45-75%), it is recommended to interrupt lenalidomide treatment until PLT count returns to ≥~     25 Gi/L on at least 2 occasions for ≥ 7 days or when the PLT count recovers to ≥ 50 Gi/L at~     any time, to resume lenalidomide at 50% dose reduction.~      Eltrombopag is an orally bioavailable agonist of the thrombopoietin receptor. It has been~     shown that in patients affected by MDS and by acute myeloid leukemia, Eltrombopag neither~     increases the proliferation, nor the clonogenic growth capacity of bone marrow blasts.~     Furthermore, Eltrombopag induces an increase in the megakaryocytic differentiation and in the~     formation of normal megakaryocytic colonies. These results provide the rationale for pursuing~     further research on Eltrombopag for the treatment of thrombocytopenia in case of MDS.~      Preliminary results of an ongoing randomized trial, EQoL-MDS, for the evaluation of efficacy,~     safety of eltrombopag for thrombocytopenia of low and intermediate-1 IPSS risk MDS has shown~     that eltrombopag is able to significantly raise PLT counts in about 65% of patients without~     additional toxicity Furthermore, the combination of lenalidomide and eltrombopag resulted in~     significant inhibitory effects on the growth of leukemic colonies in the majority of primary~     MDS and AML samples. Most importantly, eltrombopag was able to reverse the~     anti-megakaryopoietic effects of lenalidomide in primary MDS patient samples. These results~     provide a preclinical rationale for the use of this combination in MDS and AML~   "
48782|NCT02928406|"~     This Phase IIIb, multicenter study will assess the safety of atezolizumab as second- to~     fourth-line treatment for participants with locally advanced or metastatic urothelial or~     non-urothelial cancer of the urinary tract in addition to evaluate the efficacy of~     atezolizumab and potential tumor biomarkers associated with atezolizumab.~   "
48783|NCT02928393|"~     This Phase IIa, randomized, double-blind, placebo-controlled, parallel group study will~     evaluate the safety, efficacy and pharmacodynamics of basmisanil in adult participants with~     severe motor impairment following an ischemic stroke.~   "
48784|NCT02928380|"~     In this clinical study, an experimental denture adhesive with a precision tip nozzle was~     tested to evaluate the relative efficacy to reduce the ingress of food under the denture~     compared to use of no adhesive or a standard marketed adhesive.~   "
48785|NCT02928367|"~     Community-acquired pneumonia (CAP) represents a major health care problem and mortality and~     morbidity associated with severe pneumonia remain considerable, despite state of the art~     care.~      While the role of altered DNA methylation in cancer has been widely studied, knowledge of its~     impact on antibacterial defense is highly limited. In addition, recent preclinical studies~     showed that the gut and respiratory microbiota contributes to host defense against bacterial~     pneumonia.~      This study aims to explore a completely novel research area linking the extent of DNA~     methylation in blood leukocyte (monocytes and neutrophils) and function of gut and~     respiratory microbiota on the influence of innate immune responses to and host defense~     against CAP~   "
48786|NCT02928354|"~     This study is an open label, randomized, three-way crossover study to assess the effect of~     particle size on the PK and safety of single inhaled doses of AZD7594 in healthy subjects~     (males aged 18 to 55 years [inclusive]). The study will be performed at a single study~     center.~   "
48787|NCT02928341|"~     The aim of the study is to evaluate the impact of a large-scale urban water supply~     improvement intervention on cholera and other diarrhoeal diseases. The study uses a step~     wedge cluster randomised controlled trial (SWcRCT) to measure the effect of the intervention~     on cholera centre admission rates and confirmed cholera cases. A nested cohort study will~     examine changes in water-related practices following the intervention.~   "
48788|NCT02928328|"~     The effect of peripheral GABAA receptor activation on pain and sensitivity in healthy human~     subjects has never been investigated. However, as earlier studies suggest that activation of~     peripheral GABAA receptors is anti-nociceptive in rats, it is important to determine if these~     findings can be translated into human subjects to determine if peripheral GABAA receptors are~     a viable target for future analgesic drug development.~   "
48789|NCT02928315|"~     It is well known that magnesium sulfate has a membrane stabilizing effect , and broad~     spectrum anti arrhythmic properties. In this trial, the investigators study its prophylactic~     effect against atrial fibrillation in postoperative period of cardiac surgery.~   "
48790|NCT02928302|"~     Preterm birth (PTB) is a major cause of perinatal morbidity and mortality. Worldwide, about~     15 million babies are born too soon every year, causing 1.1 million deaths, as well as short-~     and long-term disability in countless survivors. Few prognostic tests are available to~     predict PTB. A short transvaginal ultrasound cervical length (TVU CL) has been shown to be a~     good predictor of PTB.Different strategies have been adopted for prevention of PTB. The~     evidence supports the use of vaginal progesterone in singleton pregnancies with short cervix,~     while cervical cerclage seems to be beneficial only in the subgroup of singleton gestations~     with both prior spontaneous PTB and TVU CL ≤25mm, and not in singletons without prior PTB,~     nor in multiple gestations.~      However, so far there are no level-1 data on the efficacy of TVU CL screening neither in low~     risk nor in high risk pregnancy Thus, we aim to assess the efficacy of a policy of TVU CL~     screening in singleton pregnancy without prior spontaneous PTB~   "
48791|NCT02928289|"~     The purpose of this study is to evaluate the safety and effectiveness of the Sight Sciences~     VISCO™360 Viscosurgical System in reducing intraocular pressure (IOP) in adult, pseudophakic~     subjects with open-angle glaucoma.~   "
48792|NCT02928276|"~     RA is the most common inflammatory, persistent and progressive disease of the joints with~     serious co-morbidities and huge health and socio-economic impact worldwide.~   "
48793|NCT02928263|"~     A retrospective study to evaluate healthcare cost and resource utilization for patients with~     metastatic renal cell carcinoma who have been treated with IV or oral agents~   "
48796|NCT02928224|"~     This is a multicenter, randomized, open-label, 3-arm Phase 3 study to evaluate encorafenib +~     cetuximab plus or minus binimetinib versus Investigator's choice of either~     irinotecan/cetuximab or FOLFIRI/cetuximab, as controls, in patients with BRAFV600E mCRC whose~     disease has progressed after 1 or 2 prior regimens in the metastatic setting. The study~     contains a Safety Lead-in Phase in which the safety and tolerability of encorafenib +~     binimetinib + cetuximab will be assessed prior to the Phase 3 portion of the study.~   "
48797|NCT02928211|"~     This is an open-label study to evaluate Aftobetin-HCl and florescence detection as measured~     by the Sapphire II device.~      Performance of Part I of the study has been completed (15 subjects received a single~     administration of Aftobetin HCL followed by Sapphire II measurements) and indicated that 3~     administrations of Aftobetin-HCl are necessary. For Part II, a second group of up to 30~     subjects (CN =10 and mild AD or MCI =20) will receive three Aftobetin HCL administrations. If~     three administrations of Aftobetin HCL are optimal, up to an additional 30 MCI and 30 mild AD~     subjects will be entered.~      The purpose of the study as Part II is performed is to determine the ability of the Sapphire~     II device to detect B-amyloid in the lens of the eye in subjects with Mild Cognitive~     Impairment (MCI), and mild Alzheimer's Disease (AD) after three Aftobetin-HCl~     administrations. Subjects with Normal Cognition (CN) will also be tested to further establish~     that subjects who are highly unlikely to have B-amyloid deposits in the lens of the eye will~     have close to baseline post ligand fluorescent uptake value (FUV) using the Sapphire II~     technology.~   "
48798|NCT02928198|"~     The Bifurcation ABSORB OCT Trial is a prospective, randomized (1:1) evaluation of the~     efficacy and performance of single ABSORB everolimus eluting bioresorbable vascular scaffold~     provisional strategy in the treatment of (a) coronary bifurcation lesion(s) in consecutive~     subjects with and without fenestration towards the side branch.~      Patients included in this study will be divided into three different cohorts:~        -  Cohort A (patient 1-20): Angiographic FU with OCT at 12 months.~        -  Cohort B (patient 21-40): Angiographic FU with OCT at 24 months.~        -  Cohort C (patient 41-60): Angiographic FU with OCT at 36 months.~      All patients will also have telephone FU at 30 days, 12, 24 and 36 months.~      Inclusion of patients in the BISORB OCT trial stopped in November 2016 after safety concerns~     of the ABSORB BVS were reported. BISORB OCT included 3 patients, which were all included in~     the Academic Medical Center~   "
48799|NCT02928185|"~     The purpose of this study is to see what the patients perceptions are of the Coping Together~     manuals during the first 100 days after their Hematopoietic Stem Cell Transplantation (HSCT),~     and if they would make any changes to Coping Together manuals for future patients, caregivers~     and couples that use these manuals after their HSCT. The investigators would also like to see~     what is the caregiver's perception of this intervention, and to see if they have any~     suggestions for changes. If the caregiver is interested in providing feedback, they will sign~     a separate consent form.~   "
48800|NCT02928172|"~     Hypothesis:~      There is a statistically measurable correlation between qNOX and rough clinical signs of~     insufficient anti-nociception such as movements during Laryngeal Mask Airway (LMA) insertion,~     skin Incision, LMA removal. It will reduce the problem of anticipating the nociception in~     patients undergoing general anesthesia.~      Objectives:~        1. to compare two indexes of hypnosis, the qCON (Quantium Medical, Spain) with the~          Bispectral index (BIS™) (Covidien, Boulder CO. USA), in patients undergoing surgery~          under sedation and general anesthesia.~        2. to assess the qNOX index of pain/nociception (Quantium Medical, Barcelona, Spain) and~          the qCON index of hypnosis.~        3. to assess qNOX reliability as a specific indicator of response to nociceptive~          stimulation.~   "
48801|NCT02928159|"~     This study assesses the feasibility of a full course of Low Pulse Amplitude-Seizure Therapy~     (LAP-ST) (primary outcome).~   "
48802|NCT02928146|"~     The aim of the study is to evaluate the effectiveness of various methods of inguinal hernia~     repair and to evaluate techniques of synthetic mesh fixation during laparoscopic and open~     hernia repair.~   "
48803|NCT02928133|"~     Rationale: Adult patients with congenital heart disease (CHD) with atrial tachyarrhythmias~     need to be anticoagulated. It is not known whether non-vitamin K antagonist oral~     anticoagulants (NOAC) in this patient group are efficient and safe.~      Aim: The purpose of the NOTE registry is to evaluate the efficacy and safety of NOACs for~     thromboembolic prevention in atrial tachyarrhythmias in adult patients with congenital heart~     disease (CHD).~      Methods: In this multicenter prospective registry adult CHD patients with atrial~     tachyarrhythmias on NOACs (switch from VKA or new on anticoagulants) will be followed for a~     minimum of two years.~      Primary efficacy endpoints are defined as thromboembolism, i.e. the composite of ischemic~     stroke, systemic and pulmonary embolism and intracardiac thrombosis, and as the composite of~     stroke and systemic embolism. Primary safety endpoint is defined as major bleeding according~     to the ISTH criteria. Secondary endpoints include each thromboembolic or bleeding event~     analysed separately, all-cause mortality, therapy adherence, quality of life, risk assessment~     of stroke and evaluation of natural history of atrial tachyarrhythmia in adult CHD patients.~      Primary endpoint assessment will be performed with a per protocol analysis, and demonstrated~     as Kaplan Meyer estimates of event free survival and event rates per year.~   "
48804|NCT02928120|"~     Colorectal cancer (CRC) is one of the most common forms of cancer and the second leading~     cause of cancer-related deaths in the western world.~      CRC mortality is related to stage of disease with a five year survival for early-stage~     disease of 77.0% and 50.8% for late stage disease. Methods for early detection of primary as~     well as recurrent CRC are therefore important to increase patient survival. Tumour biomarkers~     from blood, stool, or urine could aid the early diagnostics of CRC, but despite extensive~     research such markers have only provided limited clinical value.~      Sporadic CRC develops as a result of the accumulation of genetic and epigenetic alterations.~     Epigenetic alterations include DNA hypermethylation, which through transcriptional silencing~     of tumour suppressor genes is associated with cancer development and cancer progression. The~     search for gene promoter regions hypermethylated in cancer has been ongoing for nearly two~     decades, and a number of genes have been shown to be preferentially hypermethylated in CRC.~     Therefore, hypermethylated DNA in plasma has been suggested as a marker for tumour-stage and~     survival in CRC patients. The only approved biomarker for the detection of CRC recurrence is~     the protein carcinoembryonic antigen (CEA). CEA is limited by its low sensitivity and~     therefore not recommended as a diagnostic biomarker. Hypermethylation of CRC specific genes~     as part of a molecular biomarker panel measured in blood could prove to be a recurrence~     marker in CRC patients, with elevated sensitivity and specificity.~      The aims of this project are to examine if hypermethylation of specific genes measured from~     cell-free DNA in plasma of CRC patients can be used to detect primary CRC, to detect CRC~     recurrence and to be a biomarker for CRC prognosis.~      Development of a reliable sensitive and specific biomarker for CRC will immensely improve the~     diagnostics and handling of CRC patients.~   "
48817|NCT02927951|"~     The hypothesis of this study is that pregabalin, 150 mg bid, will reduce general daytime pain~     in patients diagnosed with diabetic peripheral neuropathy and that it will also reduce the~     level of pain associated with walking. Consequently, it is hypothesized that the reduction in~     pain will result in an increase in the amount of walking they do during the day, improvements~     in their gait, balance, risk of falls and sleep patterns.~   "
48832|NCT02927756|"~     Study purpose is to evaluate treatment outcome and survival in patient with aggressive~     lymphomas transformed from Follicular Lymphoma.~   "
48805|NCT02928107|"~     The aim of this project is to develop evidence that can inform hearing health care best~     practices for adults between the ages of 65-75, and to determine what level of involvement by~     the primary care practitioner (PCP) is required to inform and encourage adults age 65-75 to~     follow through with routine hearing screening. The ultimate goal is to provide information to~     implement changes in health care policy to facilitate accessible and affordable hearing~     health care.~      This project will compare implementation of three PCP-based hearing screening strategies that~     include progressive levels of PCP time and guidance to complete telephone-based hearing~     screening.Those who fail screening go on to a medical referral study and receive (1)~     diagnostic audiological testing and (2) determination of the reliability and validity of~     identification of conditions that should require medical referral prior to hearing aid~     provision (called FDA 'Red Flag' conditions, including conditions such as sudden hearing~     loss, cerumen impaction, conductive hearing loss, dizziness, external deformity, ear~     drainage). Adults between the ages of 65-75 years old who are being seen for a routine~     appointment at a participating Duke primary care site may be eligible to participate.~      The primary outcome measure will be the proportion of subjects in Groups 1 and 2 who dial the~     phone number and complete the test at or within two months of their PCP visit, relative to~     Group 3.~      Secondary outcome measures will be the proportion of subjects in all groups who: a) schedule~     and b) complete the visit for diagnostic audiological testing, and subsequently, c) complete~     a plan for appropriate hearing loss intervention, if indicated, within four months of initial~     hearing screening. Physical exams and procedures associated with this study present no~     significant risk to the participant.These are conducted routinely in the clinical~     setting.There is the potential for loss of confidentiality.~   "
48806|NCT02928094|"~     The purpose of this study is to determine whether a single intracoronary infusion of an~     adenovirus serotype 5 virus expressing the gene for human fibroblast growth factor-4~     (Ad5FGF-4) is effective in improving angina-limited exercise duration, angina functional~     class, frequency of angina attacks, frequency of nitroglycerin usage, and quality of life.~     Half of the study participants will receive Ad5FGF-4, and half will receive placebo. The~     primary endpoint is the change from baseline to Month 6 in Exercise Tolerance Test (ETT)~     duration. Long-term safety of Ad5FGF-4 will also be assessed.~   "
48807|NCT02928081|"~     The aim of this study is to determine whether the performance of extended lymphadenectomy in~     association with pancreatoduodenectomy improves the long-term survival in patients with~     pancreatic head ductal adenocarcinoma.Half of participants will receive pancreatoduodenectomy~     with extended lymphadenectomy,while the other half will receive pancreatoduodenectomy with~     standard lymphadenectomy.~   "
48808|NCT02928068|"~     The purpose of this study is to investigate the efficacy of a 12 week telehealth intervention~     for families of children with autism spectrum disorders under the age of 6 years on child~     participation and parent efficacy.~   "
48809|NCT02928055|"~     The primary objective of this RCT is explore the mechanism for Hemiplegic Shoulder Pain (HSP)~     reduction due to treatment with peripheral nerve stimulation. We will explore the association~     of subject-specific clinical and demographic information and pain relief from PNS. We will~     explore the possible role of central sensitization mechanisms in perpetuating pain via~     measures of sensory and pain perception. Lastly, we will explore the dose-response~     association of muscle-contraction from PNS and pain reduction, completion of activities of~     daily living (ADLs), and improvement in quality of life.~   "
48810|NCT02928042|"~     This study evaluates that P. aeruginosa, A. baumannii, K. pneumonia and Staph aureus which~     are obtained from patients' tracheal aspiration culture who treated with mechanical~     ventilation will be compared with Lactobacillus (LAB) members and nisin bactriocin in the~     laboratory. The aim is to investigate the probiotics' antimicrobial properties and effects on~     these bacteria's growth rate.~   "
48811|NCT02928029|"~     This study will be conducted in 2 parts. The phase 1b part will be an international, phase~     1b, open-label, dose-escalation assessment of radium-223 dichloride administered with~     bortezomib and dexamethasone in subjects with relapsed multiple myeloma. The primary endpoint~     is to determine the optimal dose of radium-223 dichloride in combination with~     bortezomib/dexamethasone for the Phase 2 portion of the study.~      The phase 2 part will be an international, phase 2, double-blind, randomized,~     placebo-controlled assessment of radium-223 dichloride versus placebo administered with~     bortezomib and dexamethasone, in subjects with relapsed multiple myeloma.~      Up to approximately 30 total subjects in all dose cohorts combined will be treated in the~     phase 1b part of the study and approximately 196 subjects will be enrolled in the phase 2~     part of the study.~   "
48812|NCT02928016|"~     In a randomized, cross-over designed study, the investigators examined the effectiveness of~     the carbohydrate counting method after consumption of mixed meals typical of the Greek~     cuisine with various protein and fat contents in a sample of people with type 1 diabetes~     (DM1). The investigators also tried to further explore the effects of additional extra virgin~     olive oil (11 ml) on the glycemic response.~   "
48813|NCT02928003|"~     Chronic post-thoracotomy pain is the most common long-term complication that occurs after a~     thoracotomy with a reported incidence of up to 80%. Surgical approach as well as other~     factors (genetic, psychological) could have a major and independent role in the development~     of the post operative pain.The main objective of this study is to identify genetic and~     psychological profile (cognitive and emotional) of patients who develop chronic pain after~     lung surgery.~   "
48814|NCT02927990|"~     The new software package is intended to assist the physician in imaging the coronaries during~     percutaneous coronary interventions.~      This study investigates the amount of contrast used during percutaneous coronary~     interventions with the aid of the new software package.~      The results of the study will be compared with control group data (before the new software~     package was installed or after it was removed) to define a possible contrast reduction.~   "
48815|NCT02927977|"~     The purpose of this randomized clinical trial is to verify the effectiveness of the addition~     of the dry needling in individuals with non-specific neck pain who receive a multimodal~     physical therapy rehabilitation program.~   "
48816|NCT02927964|"~     This phase Ib/II trial studies the side effects and best dose of toll-like receptor 9 (TLR9)~     agonist SD-101 when given together with ibrutinib and radiation therapy and to see how well~     they work in treating patients with grade 1-3a follicular lymphoma that has come back after a~     period of improvement or no longer responds to treatment. Immunostimulants such as TLR9~     agonist SD-101 may increase the ability of the immune system to fight infection and disease.~     Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell~     growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.~     Giving TLR9 agonist SD-101 with ibrutinib and radiation therapy may induce an immune response~     and prolong anti-tumor response.~   "
49059|NCT02924792|"~     In this study the impact of two CE marked and FDA approved sternal needles in comparison to~     intravenous access on the flow-rate of autologous reinfusion of whole blood and the possible~     hemolysis of red cells post-transfusion in a population of healthy military officers is~     investigated.~   "
48818|NCT02927938|"~     Most patients with acute myeloid leukemia (AML) achieve complete remission (CR) following~     induction chemotherapy. However, a large majority subsequently relapse and succumb to the~     disease. Currently, cytogenetics and molecular aberrations are the best prognostic~     indicators; however, these factors cannot prognosticate accurately for individual patients.~     Overall, the majority of patients with favorable or intermediate-risk AML will experience~     relapse. Prognosis after relapse is dismal with a five-year overall survival rate of less~     than 10%. A leukemia stem cell (LSC) paradigm may explain this failure of CR to reliably~     translate into cure. This study is undertaken to determine whether the presence of LSCs has~     prognostic value as well as to determine whether the presence of LSCs has predictive value.~     This study has an observational component, whereby we intent evaluate whether the presence or~     absence of LSCs is prognostic. This study also has an interventional component in which it~     uses LSC status to determine whether favorable and intermediate risk AML patients in CR~     receive consolidation with chemotherapy or allogeneic HCT.~   "
48819|NCT02927925|"~     The purpose of this study is to assess the clinical efficacy and safety of daratumumab in~     relapsed or refractory natural killer/T-cell lymphomas (NKTCL).~   "
48820|NCT02927912|"~     This phase II trial studies the side effects of intraoperative electron beam radiotherapy~     boost and to see how well it works in treating patients with stage I-II breast cancer~     undergoing surgery with reconstruction. Giving a single dose of electron beam radiation to~     the tumor cavity during the breast surgery before reconstruction may be a better way to kill~     tumor cells and shrink tumors.~   "
48821|NCT02927899|"~     This study is a sensory analysis of several different formulations of a novel~     tomato-soy-arugula seed beverage in men with prostate cancer. Eating a diet rich in a variety~     of fruits and vegetables has been associated with decreased risk of a variety of diseases,~     including prostate cancer. Mixed vegetable beverages may be useful in prostate cancer~     survivorship.~   "
48822|NCT02927886|"~     The objective of the study is to document the clinical efficacy and complications of~     endoscopic pyloromyotomy in patients with refractory gastroparesis (diabetic, post-operative~     and idiopathic), compared to Botulinic toxin injection intra-pyloric the results of which are~     close to the placebo.~   "
48823|NCT02927873|"~     The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of the~     respiratory syncytial virus (RSV) candidate vaccine when first administered via intramuscular~     (IM) injection according to a 0, 1-month schedule to RSV-seropositive infants aged 12 to 23~     months.~   "
48824|NCT02927860|"~     Show by collecting sleep and activity data, outcomes after thoracic surgery are improved with~     better sleep and increased activity.~   "
48825|NCT02927847|"~     The goal of this study is to evaluate the effects of a smoking cessation intervention~     combining behavioral treatment with low nicotine cigarettes on neuroimaging measures of~     reward function and smoking cessation outcomes. The results of this study will provide~     information about mechanisms contributing to smoking and smoking cessation and will help to~     guide future treatment studies.~   "
48826|NCT02927834|"~     Chronic rhinosinusitis is a common disease that effects millions of people world wide.~     Despite its frequency it is unclear what treatment options are the best for these patients.~     Typically patients with chronic rhinosinusitis without nasal polyps (CRSsNP) are given a long~     term antibiotic (3 weeks), nasal steroid sprays, saline nasal irrigation and occasionally~     oral steroids. Oral steroids benefit patients with chronic rhinosinusitis with nasal polyps~     (CRSwNP) however their role in non polyp patients is less clear. It is the goal of this study~     to see if oral steroids benefit the treatment outcomes in those patients with chronic~     rhinosinusitis without nasal polyps. In addition this study will look to see if a short~     course (5 day burst) versus a longer course (21 day taper) of oral steroids make a difference~     in outcomes.~   "
48827|NCT02927821|"~     Over 15 million family caregivers provide more than 85% of long-term care to older adults~     with Alzheimer's Disease and Related Disorders. Caregivers typically assume care~     responsibilities without training or support and may in turn experience multiple health risks~     including depression. Providing evidence-based caregiver supportive programs on a wide scale~     basis is identified by the National Alzheimer's Plan Act as a national priority. One approach~     is to augment existing community-based services for older adults with a caregiver~     evidence-based program. Adult day service (ADS) is one such growing and critical~     community-based option for older adults with Alzheimer's Disease and related disorders but~     which does not systematically address common caregiver challenges or burdens using~     evidence-based programs. The purpose of the study is to: 1) evaluate the effectiveness of~     Adult Day Services (ADS) Plus to improve caregiver well-being and reduce depressive symptoms~     compared to routine ADS use at 6 months; and 2) evaluate long-term maintenance effects of ADS~     Plus at 12 months on caregiver well-being and depressive symptoms. ADS Plus consists of 5 key~     components: care management, referral/linkage, education about dementia, situational~     counseling/emotional support/stress reduction techniques, and skills to manage behavioral~     symptoms (e.g., rejection of care, agitation, aggression). Based on care challenges~     identified by family caregivers, an ADS Plus Prescription is provided, a written document~     detailing easy-to-use strategies to address specified care challenges and caregivers are~     trained in their use. The proposed study will employ a practical trial design to assess the~     effectiveness and uptake of ADS Plus on a large scale. Thirty ADS programs throughout the~     U.S. varying in geographic location and staffing levels will be involved. A total of 300~     diverse caregivers (150 in 15 ADS Plus sites; 150 in 15 ADS usual care sites) will be~     enrolled.~   "
48828|NCT02927808|"~     This study will investigate the impact of motivational interviewing in achieving low-density~     lipoprotein cholesterol therapeutic targets in patients with acute coronary syndromes.~   "
48829|NCT02927795|"~     This is a self-controlled study design enrolling consented COPD patients who will be treated~     with Spiolto® Respimat® according to the approved SmPC. Patients will be enrolled~     consecutively and will be followed over an observational period of approx. 6 weeks.~   "
48830|NCT02927782|"~     Patients with persistent symptoms of cerebrospinal-fluid leakage (positional headache,~     photophobia, nausea and vomiting, clear drainage from the wound, fluctuant subcutaneous~     wound) after a primary repair should be considered for revision surgery to avoid potentially~     serious complications including CSF (cerebro spinal fluid) fistula formation. Prolonged bed~     rest immediatel after reapir of an ID () incidental durotomy) is widely accepted and~     frequently applied. current literature provides supporting retrospective evidence that~     prolonged bed rest may not be required after watertight closure of dural tears.~      The purpose of this study is to further investigate the impact of prolonged bed rest on the~     need for early reoperation following primary repair of an ID after lumbar spinal surgery. The~     primary endpoint of this study is the difference in reoperation rate between the two study~     groups to further investigate if either one or the other postoperative mobilisation regimen~     provides a significant benefit in terms of persistent dural leakage.~   "
48833|NCT02927743|"~     Inappropriate use of antibiotics in primary care is associated with Development of antibiotic~     resistant strains. As part of a quality improvement program carried out in primary care in~     Uruguay, Argentina, Paraguay and Bolivia, a cluster randomized control trial was performed.~     The aim of the study was to assess whether the use of continuous evidence-based feedback~     about management of respiratory tract infections could decrease use of antibiotics in Acute~     bronchitis, common cold and acute otitis media.~   "
48834|NCT02927730|"~     The main purpose is to evaluate the correlation in qualitative and quantitative manner~     between clinical diagnosis of retained placenta and histology. Secondly, to assess different~     clinical parameters that are likely related to accuracy of the diagnosis of RPOC~   "
48835|NCT02927717|"~     Study purpose is to evaluate baseline clinical data, outcome after front-line Rituximab~     containing chemotherapy and survival in patients with grade 3b Follicular Lymphoma.~      Also an histological central review is planned in order to re-assess baseline diagnosis~     according to new 2016 World Health Organization (WHO) criteria.~   "
48836|NCT02927704|"~     The aim of this study is to estimate GCF MCP-1 levels of healthy and Aggressive periodontitis~     (AgP) subjects and to compare MCP-1 levels between Localized AgP (LAgP) and Generalized AgP~     (GAgP) to establish its predictive value/role for distinguishing LAgP and GAgP development.~   "
48837|NCT02927691|"~     Currently, there are no efficacious behavioral treatment approaches to address uncompensated~     aspiration, or aspiration without appropriate cough response, in Parkinson's disease (PD).~     This is of particular public health concern given that aspiration pneumonia is the leading~     cause of death in persons with PD. The overarching aim of the proposed study is to determine~     the efficacy of two distinct intensive rehabilitation paradigms, expiratory muscle strength~     training (EMST) and sensorimotor treatment for airway protection (smTAP), on airway~     protective clinical outcomes in persons with PD and dysphagia. The investigators anticipate~     the results will lead to reductions in the risks associated with airway protective deficits.~   "
48838|NCT02927678|"~     Osteomyelitis is a risk factor for lower extremity amputation in diabetic people. Antibiotic~     therapy allows a remission in 60 to 80% of cases. However the optimal duration of antibiotic~     therapy remains controversy due to the absence of validated marker of osteomyelitis~     remission. We have previously shown that the negativity of white blood cell SPECT/CT (Single~     Photon Emission Computed Tomography/Computed Tomography) imaging at the end of treatment~     allowed to predict remission of osteomyelitis at 1 year in all cases. A positive imaging was~     associated with recurrence in 70% of cases. The aim of our study was to evaluate~     prospectively the interest of white blood cell SPECT/CT to set the duration of antibiotic~     therapy.~   "
48839|NCT02927665|"~     The ReShape Post Approval Study is a prospective multicenter study of the ReShape(TM)~     Integrated Dual Balloon System in Obese Subjects.~   "
48840|NCT02927652|"~     The goals of this project are aimed at the following:~        1. Identifying psychiatric comorbidity in patients presenting to the HNSCS clinic 1F and~          Duke Otolaryngology of Raleigh clinic using the validated assessment tool Brief Symptom~          Inventory (BSI-18) and the patient control scale. The BSI-18 is an 18 question and~          patient control an 8 item tool that takes about four minutes to complete.~        2. Gathering data regarding patient satisfaction in new patients to the HNSCS clinics via~          the CG-CAHPS visit survey.~        3. Examining relationships between psychiatric comorbidity and patient satisfaction.~        4. Examining relationships between psychiatric comorbidity and healthcare system use.~   "
48841|NCT02927639|"~     To develop a text messaging intervention using MyDiaText and to determine whether such an~     intervention will decrease HbA1c in children 12 to 18 years old. The intervention will~     consist of daily text messages sent to the subject's personal mobile device. Previously~     developed text messages based on the American Diabetes Association (ADA) behavior goals will~     be used for this intervention. These will be adapted with input from the focus groups that~     will be carried out with adolescents with Type 1 diabetes mellitus (T1DM). The details of the~     intervention, such as frequency and timing of text messages, will be determined from input~     obtained from the focus groups.~   "
48842|NCT02927626|"~     Clinical research of Yang Yin Fu Zheng therapy in HBV associated hepatocellular carcinoma~     basing on immune microenviroment.The purpose of this study is to observe the efficacy of~     routine medical care combined with Yang Yin Fu Zheng therapy for patients belong to HBV-HCC.~   "
48843|NCT02927613|"~     This study aims to describe the patient characteristics, feasibility, and outcomes of an home~     mechanical ventilation (HMV) program at a university hospital in Thailand.~   "
48844|NCT02927600|"~     The primary objective is to determine which among high vs low Glycemic Index (GI) / Glycemic~     Responses (GR) interventions at breakfast or at dinner is the most effective for lowering~     glycemic response of the subsequent standard meal.~   "
48845|NCT02927587|"~     Target-Controlled Infusion (TCI) of Propofol has been proved to be a safe agent for conscious~     sedation in flexible bronchoscopy (FB) .However, the target setting of effect-site~     concentration (Cet) of propofol is still unclear in the elderly population .The aim of this~     study was to compare two induction Cet of propofol in elderly patients undergoing flexible~     bronchoscopy.~   "
48846|NCT02927574|"~     Restenosis is still an issue after endovascular revascularization for femoropopliteal~     occlusive disease. One approach to reduce the rates of restenosis and reintervention is local~     application of Paclitaxel with drug-coated balloon angioplasty. The purpose is to conduct a~     systematic review and meta-analysis of randomized-controlled trials comparing on Drug-Coated~     Balloon angioplasty (DCB) vs. Plain Old Balloon Angioplasty (POBA) in de-novo femoropopliteal~     disease.~   "
48847|NCT02927561|"~     In Brazil 10% of the adult population has diabetes. Of these, 39.0% are undiagnosed, at risk~     for developing complications such as diabetic retinopathy (DR). Due to the increasing~     prevalence of diabetes and high percentage of patients with uncontrolled disease,~     cost-effective tools are needed with focused attention on diabetes prevention and management~     in the current health system. The automatic retinopathy detection can enlarge the screening,~     reducing the workload and costs compared to manual image graders.~   "
48848|NCT02927548|"~     This is a single-center retrospective study that evaluates the effectiveness and long-term~     safety of the TVT tape ( advantage Boston Scientific) in the treatment of stress urinary~     incontinence in women on a population of 500 patients with a mean follow-up of 6 years.~   "
48849|NCT02927535|"~     Aim: To describe 1) The use of TNF blockers monotherapy in early arthritis in daily clinical~     practice in France 2) To evaluate symptomatic, structural efficacy, and retention rate over 5~     years of TNF blockers monotherapy 3) To evaluate predictive factors for TNF blocker response~     monotherapy Type of study: Observational cohort study using cross-section and longitudinal~     data.~      Description of the project methodology~        -  Patients: All patients in the ESPOIR cohort (multicentre French cohort study of early~          RA).A sub-analysis will be conducted among patients satisfying the ACR-EULAR 2010~          criteria.~        -  Data collected: Patient characteristics, Clinical data regarding RA and related~          pathologies, Characteristics of treatments received The analysis will be conducted using~          data collected at baseline, 6, 12, 18, 24, 36, 48, 60 months.~        -  Analyses:~             1. Frequency of use of TNF blockers monotherapy: we will calculate the % of patients~               initiating TNF blockers monotherapy (Kaplan-Meier method), and we will describe the~               type of TNF blocker, the route of administration, the dosage, and the place of the~               TNF blockers monotherapy in the treatment strategy during the first 5 years.~             2. Identification of potential predictive factors for initiation of TNF blockers~               monotherapy: a survival curve (Kaplan-Meier) will be performed. The baseline~               characteristics of the patients with regard to the initiation of TNF blocker~               monotherapy during the first 5 years of the disease will be compared by univariate~               analysis and Log-rank test will be performed in all variables. A stepwise~               multivariate analysis (Cox analysis) will be performed.~             3. Therapeutical effect: we will calculate the retention rate over time, and will~               compare the changes in different variables in the group of patients who have~               received TNF blockers monotherapy matched (using a propensity score) to 1,2 or 3~               patients who have received TNF blockers in combination with synthetic DMARDs. We~               will assess and compare DAS28 and HAQ at short term (after at least 8 weeks of~               treatment) and long term (last available visit) in groups. The structural efficacy~               was evaluated by the radiographic progression at last available visit. We will~               identically estimate the drug effect depending on the TNF blocker used, by~               calculating the retention rate and comparing DAS28 at short term and long term.~             4. Identification of predictive factors for TNF blocker monotherapy response: To~               evaluate the impact of baseline demographics and disease conditions on the DAS28~               and HAQ response during the first 5 years will be compared by univariate and~               multivariate analysis.~      Expected results:~      Increase knowledge on the use of TNF blocker monotherapy, its efficacy and retention rate,~     and on predictive factors for TNF blocker monotherapy response in early RA patients.~   "
48850|NCT02927522|"~     Postoperative cognitive dysfunction (POCD) occurs mainly in aged patients. POCD may increase~     the mortality and morbidity. However, the mechanism of POCD is not clear yet and no effective~     therapy method was proved. According to our previous study, the central cholinergic system~     impaired by the anesthesia and surgery play a very important role in the POCD and donepezil~     an acetylcholinesterase inhibitor can prevent the POCD after isoflurane anesthesia in aged~     mice. Donepezil is a commercial medicine used for the Alzheimer Disease, which is tolerable~     and has minimal adverse events. In present study a multi-center randomized case control study~     was conducted and we hypothesized that donepezil attenuate the POCD.~   "
48851|NCT02927509|"~     Aim: To describe 1) The use of TNF blockers in early arthritis in daily clinical practice in~     France 2) To evaluate symptomatic, structural efficacy, and retention rate over 5 years 3) To~     evaluate predictive factors for TNF blocker response Type of study: Observational cohort~     study using cross-section and longitudinal data.~      Description of the project methodology~        -  Patients: All patients in the ESPOIR cohort (multicentre French cohort study of early~          RA).A sub-analysis will be conducted among patients satisfying the ACREULAR 2010~          criteria.~        -  Data collected: Patient characteristics, Clinical data regarding RA and related~          pathologies, Characteristics of treatments received The analysis will be conducted using~          data collected at baseline, 6, 12, 18, 24, 36, 48, 60 months.~        -  Analyses:~             1. Frequency of use of TNF blockers: the % of patients initiating TNF blockers will be~               calculated (Kaplan-Meier method), and the type of TNF blocker will be described,~               the route of administration, the dosage, the association with other DMARDs and the~               place of the TNF blockers in the treatment strategy during the first 5 years.~             2. Implementation of EULAR recommendations: the percentage of patients that initiate~               TNF blockers meeting the EULAR criteria for initiation will be estimated, and the~               concordance coefficient Kappa with regard to such fulfilment and the initiation of~               TNF blockers will be calculated, and disease severity outcome measures will be~               compared depending on the fulfilment or not.~             3. Identification of potential predictive factors for initiation of TNF blockers: a~               survival curve (Kaplan-Meier) will be performed. The baseline characteristics of~               the patients with regard to the initiation of TNF blocker during the first 5 years~               of the disease will be compared by univariate analysis and Log-rank test will be~               performed in all variables. A stepwise multivariate analysis (Cox analysis) will be~               performed.~             4. Therapeutical effect:the retention rate over time will be calculated, the changes~               in different variables will be compared in the group of patients who have received~               TNF blockers matched (using a propensity score) to 1,2 or 3 patients who have not.~               The DAS28 and HAQ will be assessed and compared at the short term (after at least 8~               weeks of treatment) and long term (last available visit) in groups. The structural~               efficacy was evaluated by the radiographic progression at last available visit.The~               drug effect will be identically estimated depending on the TNF blocker used, by~               calculating the retention rate and comparing DAS28 at short term and long term.~           6) Identification of predictive factors for TNF blocker response: To evaluate the impact~          of baseline demographics and disease conditions on the DAS28 and HAQ response during the~          first 5 years will be compared by univariate and multivariate analysis.~      Expected results:~      Increase knowledge on the optimal use of TNF blocker and on predictive factors for TNF~     blocker response in early RA patients.~   "
48852|NCT02927496|"~     Current lymphedema management protocols are based on the use of simple measures of hygiene~     (regular washing with soap and water, skin and nail care), use of topical antibiotics or~     antifungal agents, exercise and footwear. This is considered the standard of care in most~     endemic countries in the absence of any structured treatment programs. Previous controlled~     clinical trials and extensive field experience have shown the benefit of these measures in~     reducing the frequency of attacks of acute dermato-lymphangio-adenitis (ADLA) that drive the~     progression of lymphedema.~      In the present study, the progression of lymphedema in a group of patients who receive a~     six-week course of doxycycline will be compared with that of a group who receives doxycycline~     look-alike placebo tablets. However, both groups will be enrolled into a standardized~     regimen of hygiene described above. Thus, patients enrolled in the placebo group also~     will receive the current standard of care, and the placebo used in the study will help to~     identify the benefits of doxycycline on a background of simple hygiene measures. The regimens~     will be explained to all participants who will be trained to use established standardized~     methods of hygiene and be effectively applying it prior to the initiation of the drug~     treatment. In addition, patients will be evaluated at 3, 6, 12 and 24 months.. A common,~     generic SOP with handouts that describes methods and the training schedule will be used so~     that similar methods are employed across all sites.~   "
48853|NCT02927483|"~     The trial is designed as a randomized, multicenter, open label, comparative, 6 months,~     clinical study.~   "
48854|NCT02927470|"~     The purpose of this study is to understand how the brain allows individuals to keep~     information in mind over brief intervals. During the experiment, participants will be asked~     to maintain fixation while they attend to and remember different visual stimuli (e.g., the~     location of a dot on the screen, the color of a circle, the orientation of a line, the speed~     of a group of moving dots) on a computer monitor. Participants will make decisions about~     these visual stimuli and indicate their decisions by pressing buttons or making eye~     movements. Through the use of Transcranial Magnetic Stimulation (TMS) investigators hope to~     understand the contributions of different anatomical areas while subjects perform this task.~   "
48865|NCT02927327|"~     The purpose of the study is to collect representative clinical images (head and whole-body~     scans) of demonstrated diagnostic quality using the next-generation SIGNA PET/MR device~     equipped with investigational software components in adult population. The images and summary~     data from this study are intended for use in regulatory submission.~   "
48866|NCT02927314|"~     This is a multicenter, randomized, double-blind, placebo-controlled clinical trial in~     subjects with NAFLD and NASH.~   "
48867|NCT02927301|"~     This study is designed to evaluate the safety and efficacy of neoadjuvant and adjuvant~     atezolizumab in participants with resectable Non-Small Cell Lung Cancer (NSCLC). Neoadjuvant~     therapy will consist of two 21-day cycles with atezolizumab. Following surgery, adjuvant~     therapy will consist of up to 12 months of atezolizumab in participants who demonstrate~     clinical benefit with neoadjuvant therapy.~   "
48855|NCT02927457|"~     This study is designed to examine safety, tolerability, pharmacokinetics, pharmacodynamics~     and clinical effect of repeat dosing of GSK2646264 in patients with subacute and chronic~     cutaneous lupus erythematosus (CLE) lesions and in acute CLE like lesions induced by~     photoprovocation (PV).~      Current study is two group study. In Group A, Patients with fewer than two active lesions~     will be enrolled and exposed to photoprovocation (PV) for 3 consecutive days. Patients that~     develop PV lesions at any time during this period, as determined by the local investigative~     team, will receive 1% strength GSK2646264 on 1 lesion and placebo on 1 lesion daily and~     either 1% strength GSK2646264 or placebo on an area of uninvolved skin, for skin~     pharmacokinetic (PK) of study drug, for 28 days.~      In Group B, Patients that have a minimum of 2 active existing CLE lesions as determined by~     the investigators will be enrolled into group B and have one lesion treated with 1%~     GSK2646264 and 1 lesion with placebo.~      A completed patient will be defined as a subject who receives at least 25 days of study drug~     and completes the end of treatment biopsy (at day 28) and assessment. Thereafter patients~     will be followed for 28 days in Group A only or until complete resolution of induced PV~     lesions, as determined by the investigator.~   "
48856|NCT02927444|"~     This study will assess the immunogenicity and safety of booster vaccination with NBP606~     compared to the existing commercial vaccine, when given concomitantly with routine pediatric~     vaccinations.~   "
48857|NCT02927431|"~     Danirixin (DNX) is a novel, selective, and reversible antagonist of the C-X-C chemokine~     receptor (CXCR) 2 and has been shown to decrease neutrophil transmigration and activation to~     areas of inflammation. An intravenous (IV) formulation of DNX hydrobromide (HBr) is being~     developed as an anti-inflammatory agent for treatment of adults hospitalized with influenza~     (IFV). While early therapy with antivirals decreases severity and duration of symptoms of~     influenza, there are no drugs that have demonstrated clinical efficacy in randomized clinical~     trials in this population. Current treatment guidelines for hospitalized IFV recommend~     neuraminidase inhibitors as standard of care therapy. IFV studies in animals have~     demonstrated that therapeutic treatment with the combination of a CXCR2 antagonist and a~     neuraminidase inhibitor reduced lung neutrophils and showed trends for improvements in~     clinical scores, lung function and pathology with no evidence of worsening outcomes,~     including viral load. This Phase 2, randomized, double-blind (for IV DNX), placebo-controlled~     (for IV DNX) 3-arm study will be the first study to determine the efficacy and safety of IV~     DNX when co-administered (in all groups) with standard of care antiviral treatment~     (open-label oral oseltamivir [OSV]) in subjects hospitalized with IFV. The primary objective~     of the study is to assess the efficacy of treatment with IV DNX twice daily given with oral~     OSV compared to oral OSV twice daily on time to clinical response (TTCR). In this study,~     subjects will be randomized in a 2:2:1 ratio to 15 milligram (mg) free base equivalent (FBE)~     IV DNX, 50 mg FBE IV DNX, or matching placebo twice daily. All subjects will also receive~     open-label 75 mg oral OSV, twice daily (given as standard of care). The study treatment~     duration will be for up to 5 days. The investigator may elect to continue treatment with OSV~     after 5 days of study treatment. Follow up will continue until Day 45 for all subjects. The~     study will begin with enhanced safety monitoring in sentinel cohorts, leading to stepwise~     enrollment of subjects. Subjects will be enrolled based on increasing levels of renal~     impairment, and less severe hospitalized subjects will be enrolled prior to enrollment of~     critically ill subjects, as this is the first study conducted in the hospitalized population~     with severe IFV. Approximately 300 subjects are targeted to be enrolled in the study.~   "
48858|NCT02927418|"~     The purpose of this study is to explore the effects of a strength & conditioning (S & C)~     program on risk factors for injury (Y-balance and Functional Movement Screen scores), as well~     as parent reported injury occurrence in 12-16 year old male and female athletes. Forty girls~     and 40 boys aged 12-16 will be recruited; half will participate in supervised S & C sessions~     2-3x/week while the other half will continue with their regular sports and activities. Risk~     factors for injury and performance indices (20 m sprint and multiple jump test) will be~     assessed before and after the 4 month study. Injury occurrence will be recorded via bi-weekly~     phone calls to the parent and athlete.~   "
48859|NCT02927405|"~     There is an increasing trend on decreasing narcotic use and maximizing efficiency in the~     perioperative care. There are no studies that have compared a TAP block versus a TAP block~     plus gabapentin for laparoscopic procures.This study will investigate if taking gabapentin~     and receiving a TAP block decrease post-operative morphine consumption. It will be a~     randomized controlled, double blind study, with 130 patients between 18-60 years; that will~     undergo laparoscopic GYN procedures. Secondary outcomes will look at the incidence of nausea,~     vomiting, and VAS (verbal analog scale) scores. This combination may be helpful because~     gabapentin will be used to decrease visceral and central pain, and TAP block will decrease~     somatic pain. Performing a multimodal approach may decrease narcotic consumption, adverse~     effects and improve pain management.~   "
48860|NCT02927392|"~     The physiological relevance of brown adipose tissue (BAT) in humans is largely unknown. The~     investigators have shown that suppressing ovarian function in premenopausal women reduces~     resting energy expenditure (REE), and this is prevented by adding back estradiol (E2). The~     investigators preliminary data suggest that this may be due, in part, to reduced brown~     adipose tissue (BAT) activity. The overarching hypothesis is that BAT activity in humans is~     modulated by E2. To determine if natural declines in endogenous E2 contribute to changes in~     BAT activity, we will compare BAT activity in pre-and post-menopausal women. The~     investigators will also explore whether suppression of ovarian hormones in pre-menopausal~     women impairs BAT activity. BAT activity will be quantified using dynamic positron emission~     topography/computed tomography (PET/CT) imaging combined with 11C-acetate tracers. We will~     assess the thermogenic response of BAT by measuring cold-induced changes in REE, shivering,~     and skin and core temperature.~   "
48861|NCT02927379|"~     This study aims to compare the effects of local wound infiltration with ketamine versus~     dexmedetomidine when added to bupivacaine on stress response and postoperative pain in lower~     abdominal cancer surgery.~   "
48862|NCT02927366|"~     This is a non-confirmatory, randomized, subject and investigator blinded, placebo controlled~     study of QCC374 in PAH patients. The study will have 2 parts. In Part 1, an initial safety~     cohort, 8 subjects will be randomized in a 6:2 ratio and the starting dose will be 0.03 mg~     b.i.d.. In Part 2, ~ 30 subjects will be randomized in a 2:1 ratio, with a planned starting~     dose of 0.06 mg b.i.d.. In both Parts, subjects will be up-titrated during the first two~     weeks of the study to 0.12 mg b.i.d, or to their maximum tolerated dose (MTD) if their~     individual MTD is below 0.12 mg b.i.d. during the first two weeks of the study. The treatment~     duration is 16 weeks.~   "
48863|NCT02927353|"~     To determine the pharmacokinetic bioequivalence of DMB-3113 and adalimumab and to confirm the~     safety of the study drug in healthy Japanese adult male subjects~   "
48864|NCT02927340|"~     This research study is studying a drug as a possible treatment for ALK-positive or~     ROS1-positive non-small cell lung cancer (NSCLC).~      The following drug will be involved in this study :~        -  Lorlatinib~   "
48868|NCT02927288|"~     The purpose of this study is to develop a new test to help diagnose mild traumatic brain~     injury (mTBI) and post-traumatic stress disorder (PTSD) in soldiers. Chemicals in the brain~     will be measured using a Magnetic Resonance Spectroscopy (MRS) scan. In the study, the~     investigators will compare the information they obtain from scans of participants with mTBI,~     PTSD or both, to scans from healthy volunteers to understand the differences between these~     groups. If the results can tell the difference between participants with mTBI and PTSD, the~     investigators should be able to help safely diagnose patients in the future.~   "
48869|NCT02927275|"~     The purpose of this study is to evaluate the effect of low-intensity exercise on cognitive~     functioning during activity. Evaluation was accomplished by having participants perform~     standardized cognitive tests while in three forms of low-intensity exercise and then~     comparing results to performance when sitting.~   "
48870|NCT02927262|"~     The purpose of this study is to compare relapse-free survival (RFS) between subjects with~     FMS-like tyrosine kinase 3 (FLT3) / internal tandem duplication (ITD) acute myeloid leukemia~     (AML) in first complete remission (CR1) and who are randomized to receive gilteritinib or~     placebo beginning after completion of induction/consolidation chemotherapy for a two-year~     period.~   "
48871|NCT02927249|"~     This randomized phase III trial studies how well aspirin works in preventing the cancer from~     coming back (recurrence) in patients with human epidermal growth factor receptor 2 (HER2)~     breast cancer after chemotherapy, surgery, and/or radiation therapy. Aspirin is a drug that~     reduces pain, fever, inflammation, and blood clotting. It is also being studied in cancer~     prevention. Giving aspirin may reduce the rate of cancer recurrence in patients with breast~     cancer.~   "
48872|NCT02927236|"~     Background:~      More effective treatments for people with cocaine use disorder are needed. Researchers want~     to understand the parts of the brain involved in the disorder. Transcranial magnetic~     stimulation (TMS) stimulates parts of the brain. A form of TMS called intermittent~     theta-burst stimulation (iTBS) may help reduce cocaine use. Researchers want to learn how the~     brain might change with treatment.~      Objectives:~      To test if iTBS can reduce cocaine use. Also, to learn how cocaine changes the heart and the~     brain.~      Eligibility:~      Healthy, right-handed adults ages 18-60 who do or do not have cocaine use disorder.~      Design:~      Participants will be screened with:~        -  Questionnaires~        -  Medical history~        -  Physical exam~        -  Blood and urine tests~        -  Alcohol breath tests~      In the pilot study, 10 participants with cocaine use disorder will have 10 treatment days~     over 2 weeks. Half will be inpatient and half will be outpatient. They will have 2 follow-up~     visits. Treatment includes:~        -  iTBS: A coil is placed on the head. A brief electrical current passes through the coil.~          They view cocaine-related images during each session. Sessions are videotaped.~        -  Repeat of screening tests~             -  In the main study, participants will be randomly assigned to have either real or~               fake iTBS.~             -  Participants with cocaine use disorder will join an incentive program to quit.~             -  Participants will have 39 visits over 6 months. These include:~        -  Repeat of screening tests~        -  MRIs at 5 visits: Participants lie on a table that slides into a cylinder that takes~          pictures of the brain. They respond to images while in the scanner.~        -  iTBS at 10 visits (5 days a week for 2 weeks)~      Participants will be contacted throughout the study to discuss iTBS treatment and drug use.~   "
48873|NCT02927223|"~     To test the hypothesis that increasing the sinus node rate with atropine treatment prior to~     exercise will reduce exercise-triggered ventricular ectopy compared to baseline in patients~     with CPVT.~   "
48874|NCT02927210|"~     This is a Phase I multicenter, double-blind, single dose, dose-ranging study, in healthy men~     to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of~     Dimethandrolone Undecanoate (DMAU) administered as an intramuscular or subcutaneous~     injection.~   "
48875|NCT02927197|"~     The purpose of this study is to examine changes in multiple cognitive skills after completing~     60 hours of cognitive training with ThinkRx, a LearningRx program.~   "
48876|NCT02927184|"~     This study will investigate the efficacy, safety, and tolerability of VK2809 in lowering~     LDL-C and liver fat content in patients with primary hypercholesterolemia and fatty liver~     disease. The primary efficacy endpoint is percent change from baseline LDL-C at the end of~     the treatment period (Week 12). Secondary endpoints include effects on liver fat content and~     other liver and lipid markers, as well as effects on safety and tolerability, and~     pharmacokinetic (PK) measurements.~   "
48877|NCT02927171|"~     This study seeks to improve rehabilitation methods for restoring physical function with~     skilled nursing facility care. More specifically, this study is designed to evaluate the~     effectiveness of an intensive therapeutic rehabilitation program for older adult skilled~     nursing home residents compared to usual care.~   "
48878|NCT02927158|"~     This study is designed to utilize whole exome and whole genome sequencing techniques to~     identify underlying genetic causes for undiagnosed disorders in the Plain Communities, and to~     do population genetic studies looking at genetic drift and founder mutations in this unique~     population.~   "
48879|NCT02927145|"~     This is an open-label, multi-centre Phase I/IIa dose escalation blood-stage malaria CHMI~     trial to assess the safety, immunogenicity and efficacy of the candidate malaria vaccine~     RH5.1/AS01. All volunteers recruited will be healthy, malaria naïve adults aged between 18~     and 45 years.~      Volunteers will be recruited and vaccinated at the CCVTM, Oxford; Guys and St Thomas' NIHR~     CRF, London; and the NIHR WTCRF, Southampton for the Phase Ia part of the trial, and at the~     CCVTM, Oxford and Guys and St Thomas' NIHR CRF, London for the Phase IIa stage.~   "
48880|NCT02927132|"~     This research seeks to evaluate expressive writing as a novel intervention for problem~     drinking among college students. The vast majority of individually focused brief~     interventions targeting college drinking have focused on personalized feedback approaches and~     recent innovations have largely been limited to finer distinctions of these, which require~     assessment and programming for implementation. The present research proposes expressive~     writing as a novel alternative, which has been used extensively in other domains but not as~     an alcohol intervention strategy.~      H1a: Participants writing about negative drinking events will show reduced drinking and~     drinking-related negative consequences relative to students in the neutral control group.~      H1b: Participants writing about distressing non-alcohol events will show increased~     psychological wellbeing relative to students in the neutral control group.~      H1c: Participants writing about negative drinking events will show reduced drinking and~     consequences compared with an empirically-supported brief intervention (i.e., PNF). This is~     an exploratory hypothesis.~      H2a: Alcohol narratives will have stronger effects on alcohol outcomes relative to distress~     narratives.~      H2b: Alcohol guilt narratives will have the strongest effect on alcohol outcomes relative to~     all other conditions.~      H3a: Expression of guilt, assessed by self-report and by content coding with LIWC, will~     mediate intervention effects on drinking outcomes.~      H3b: Change thought, assessed by LIWC coding, will mediate intervention effects on drinking.~   "
48881|NCT02927119|"~     The purpose of the investigation is to assess iodine status of pregnant women at week 16 of~     gestation targeting serum thyroglobulin as a biomarker of iodine deficiency. The~     investigators aim to assess whether pre-gestational initiation of iodine supplementation is~     more advantageous in comparison to supplementation start at the time of pregnancy detection.~   "
48882|NCT02927106|"~     In this study, DNA sequencing, computational biology modeling, and ex vivo drug sensitivity~     assays will be utilized to define clinically relevant gene mutations and identify potential~     therapeutics for patients with acute myeloid leukemia (AML).~   "
48883|NCT02927093|"~     The Shoklo Malaria Research Unit (SMRU) provides care to refugees and migrant populations~     along the Thai-Burma border since 1986. Services include antenatal and birthing care, with~     2,500 births per year and Special Care Baby Units (SCBU) set up in 2008; all medical records~     including clinical and laboratory data are archived. The treatment of neonatal jaundice is~     based on treatment thresholds adapted from the neonatal jaundice guidelines, published by the~     Royal College of Obstetricians and Gynaecologists, UK. Total serum bilirubin (SBR) is done at~     regular intervals to monitor neonatal hyperbilirubinemia (NH) evolution, following SMRU~     guidelines. The SCBU have been set up to provide intensive care for neonates in a resource~     constrained setting and don't have equipment for assisted ventilation other than oxygen~     therapy. Neonates presenting with high serum bilirubin levels and/or clinical signs of acute~     bilirubin encephalopathy (ABE) cannot receive exchange transfusion on site and have to be~     referred to the Thai general hospital one hour drive from the clinics; and, for those~     neonates surviving, there has not been a systematic follow-up of their growth and~     neurodevelopment.~      The study will consist of a matched case-control series and a retrospective review of SCBU~     charts of neonates with NH reaching exchange transfusion threshold. The SCBU database will be~     searched for neonates born at ≥ 28 weeks of gestation hospitalized for phototherapy between~     January 2009 and December 2014; charts will be manually researched to identify study~     participants which will be classified as NH reaching exchange transfusion threshold (cases)~     or as NH within moderate threshold (controls). Additionally neurological signs compatible~     with ABE will be searched in the clinical notes and coded as present/absent. Cases discharged~     alive from the SCBU will be traced back to evaluate their clinical and neurocognitive long~     term outcome. Each case will be matched with a moderate NH control from the same clinic, sex,~     gestational age and season of birth and hospitalized within the same month.~      The results of this study will help to improving the clinical care during the neonatal period~     and to developing a guideline for a better follow-up of children with NH reaching exchange~     transfusion threshold.~   "
48884|NCT02927080|"~     Study A083-02 is a multicenter, Phase 2 study to evaluate the safety, tolerability,~     pharmacodynamics (PD), efficacy, and pharmacokinetics (PK) of ACE 083 in patients with FSHD~     to be conducted in two parts. Part 1 is open-label, dose-escalation and Part 2 is randomized,~     double-blind, and placebo-controlled.~   "
48885|NCT02927067|"~     The purpose of this study is to compare the efficacy and safety of maribavir to~     valganciclovir for the treatment of cytomegalovirus (CMV) infection in asymptomatic~     hematopoietic stem cell transplant recipients.~   "
48886|NCT02927054|"~     A questionnaire was provided, including clinical vignettes and free text answers, to assess~     and evaluate the ability of resident physicians to identify systemic inflammatory response~     syndrome (SIRS), sepsis, and severe sepsis. Questionnaire scores were compared between~     specialties. A whole-hospital educational campaign was provided with the aim to improve~     sepsis recognition, and the questionnaire survey was repeated after one year to assess the~     effect of the education on the recognition of sepsis.~   "
48887|NCT02927041|"~     The gold standard in hemodynamic evaluation has been the combined use of echocardiography and~     right heart catheterization. Fall backs to echocardiography are its time consumption and~     requirement for specialist interpretation while the Swan-Ganz® catheter shows a poor~     correlation of central venous pressure to volume status and provides indirect and difficult~     to interpret measurements in patients with unique pathophysiological states.~      Next generation continuous hemodynamic transesophageal echocardiography (hTEE®) is being~     increasingly utilized to assist with complex resuscitations and to monitor the hemodynamic~     profiles of critically ill patients. hTEE is proving to be an essential diagnostic,~     therapeutic and monitoring tool for the rapid evaluation of the hemodynamic state in the~     critically ill patient and or hemodynamically compromised patient.~      The purpose of this observational study is to evaluate the role of hTEE in clinical~     decision-making in 30 patients recruited from OR-Trauma and in 30 patients from the~     Cardiovascular-OR. Hemodynamic trans-esophageal echocardiography (hTEE) incorporates an~     FDA-approved miniaturized, disposable probe for continuous use in patients for up to 72~     hours. This device has been used for postoperative assessment in the ICU for several years~     with successful placement of probes and without any adverse incidents.~      The probe allows for the rapid, intermittent or continuous evaluation of bi-ventricular~     function, volume status and valve function at bedside or intraoperatively. It also allows for~     the evaluation of pericardial effusions and or the exclusion of pericardial tamponade.~   "
48888|NCT02927028|"~     With an emphasis on oral processing, this study seeks to characterize the mechanisms that~     account for the high satiation properties of walnuts and low energy yield during digestion.~   "
48889|NCT02927015|"~     Assess impact of potato phytochemical on post-prandial gastric emptying and glucose release~     from products in a pilot human study.~   "
48890|NCT02927002|"~     The goal of this project is to study the effect of noninvasive brain stimulation on~     decision-making and on brain activity in impulse control disorders.~   "
48891|NCT02926989|"~     The main objective of the trial is to evaluate the risk of hypokalemia following~     administration of a isotonic solution compared to a hypotonic solution in acutely ill~     hospitalised children, who need intravenous fluid therapy.~   "
48892|NCT02926976|"~     The Optimal Treatment for Treatment-resistant Schizophrenia~   "
48893|NCT02926963|"~     Chronic granulomatous disease (CGD) is a rare genetic disease of innate immune due to the~     malfunction of phagocytic cells unable to destroy pathogens during infection. The four genes~     implicated are CYBB, CYBA, NCFA and NCF2 respectively encoding Nox2, p22phox, p47phox and~     p67phox. Nox2 analogs have recently been discovered in cells other than phagocytes. So the~     question arises on physiopathological impact of the absence of theses proteins not only in~     phagocytes but also in other cells types such as fibroblasts or neurons.~      The principal objective is thus to study the impact of protein deficits Nox2 and p22phox, in~     the pathophysiology of neurons from inducible pluripotent bone marrow cells (iPSC).~      For this purpose, a collection was built of fibroblasts and keratinocytes from patients with~     different forms of CGD to get iPSC similar to embryonic marrow cells and differentiable into~     several cell types (neurons, phagocytes).~   "
48940|NCT02926352|"~     There are two specific aims for this study. Aim 1 is to test whether low-level laser therapy~     (LLLT) can enhance the efficacy of fear extinction training in the modification of~     pathological fear. Aim 2 is to investigate the efficacy of low-level laser therapy (LLLT) as~     a stand-alone intervention for anxiety/phobias.~   "
48894|NCT02926950|"~     Primary Objective:~      To demonstrate the superiority of sotagliflozin versus placebo on hemoglobin A1c (HbA1c)~     reduction in patients with type 2 diabetes (T2D) who have inadequate glycemic control with~     metformin.~      Secondary Objectives:~        -  To compare sotagliflozin versus placebo for:~        -  Change from baseline in 2-hour postprandial glucose (PPG) following a mixed meal.~        -  Change from baseline in fasting plasma glucose (FPG);~        -  Change from Baseline in systolic blood pressure (SBP) for patients with baseline SBP~          ≥130 mmHg;~        -  Change from baseline in SBP for all patients;~        -  Change from baseline in body weight;~        -  Proportion of patients with HbA1c <6.5% and <7.0%.~        -  To evaluate the safety of sotagliflozin versus placebo.~   "
48895|NCT02926937|"~     Primary Objective:~      To demonstrate the superiority of sotagliflozin dose 1 versus placebo on hemoglobin A1c~     (HbA1c) reduction in patients with type 2 diabetes (T2D) who have inadequate glycemic control~     on diet and exercise.~      Secondary Objectives:~        -  To compare sotagliflozin dose 1 versus placebo based on:~        -  Change from baseline in 2-hour postprandial glucose (PPG) following a mixed meal;~        -  Change from baseline in fasting plasma glucose (FPG);~        -  Change from baseline in systolic blood pressure (SBP) for patients with baseline SBP~          ≥130 mmHg;~        -  Change from baseline in SBP for all patients;~        -  Change from baseline in body weight;~        -  Proportion of patients with HbA1c <6.5%, <7.0%.~        -  To compare sotagliflozin dose 2 versus placebo based on:~        -  Change from baseline in HbA1c~        -  Change from baseline in 2-hour postprandial glucose (PPG) following a mixed meal;~        -  Change from baseline in body weight;~        -  Change from baseline in SBP for all patients.~        -  To evaluate the safety of sotagliflozin doses 1 and 2 versus placebo.~   "
48896|NCT02926924|"~     This is a prospective randomized study evaluating the use of a prophylactic incision wound~     vac dressing, applied in the OR, on patients undergoing posterior spine surgery with a~     BMI>35. Patients are randomized in the operating room to normal postoperative dressing vs.~     vac dressing. The vac dressing would be left on for 72 hours postoperatively. In the interim,~     the patients' postoperative care can proceed as usual. Our primary outcomes will be~     antibiotics or return trip needed to the operating room for wound related complications.~      The patients only intervention would be the application of an incisional wound vac. The will~     be no change in the patients postoperative protocol otherwise. This procedure is noninvasive.~   "
48897|NCT02926911|"~     This study looks at the risks and benefits of active surveillance (AS) compared to guideline~     concordant care (GCC) in the setting of a pragmatic prospective randomized trial for low risk~     DCIS. Our overarching hypothesis is that management of low-risk Ductal Carcinoma in Situ~     (DCIS) using an AS approach does not yield inferior cancer or quality of life outcomes~     compared to GCC.~   "
48898|NCT02926898|"~     The primary purpose of this study is to evaluate the safety, tolerability and efficacy of a~     single dose of ZX008 (Fenfluramine Hydrochloride) when added to standard of care and when~     added to Adjunctive Antiepleptic therapy to Stiripentol treatment in children and young~     adults with Dravet Syndrome~   "
48899|NCT02926885|"~     Evaluation of a new technique of liver retraction for the exposure of the His angle in~     gastric bypass Roux-en-Y surgery.~   "
48900|NCT02926872|"~     The primary outcome of this study is the development of a clinical profile of pediatric~     patients with LAL-D, which will enable the Sponsor to provide more focused guidance to the~     medical community as to which pediatric patients should be tested for LAL-D.~   "
48901|NCT02926859|"~     Current antipsychotic treatments of schizophrenia are only partially effective, and their use~     is often associated with serious side effects. Cannabidiol is a natural counterpart of the~     psychoactive component of marijuana, delta-9- tetrahydrocannabinol and has no psychotomimetic~     or addictive properties. In a controlled clinical trial of cannabidiol versus amisulpride in~     acute paranoid schizophrenia we showed a statistically significant clinical improvement in~     all symptoms clusters of schizophrenia compared to baseline with either treatment.~     Cannabidiol displayed a significantly superior side-effect profile in particular regarding~     prolactin elevation, extrapyramidal symptoms and weight gain. The favorable side-effect~     profile and potentially novel mechanism of action identify this molecule as a potential~     antipsychotic. However, long-term safety and efficacy data is still lacking. This study is to~     evaluate the efficacy and safety of the novel compound cannabidiol in the maintenance~     treatment of schizophrenia in comparison to placebo as an add-on to an established treatment~     with either amisulpride, aripiprazole, olanzapine, quetiapine or risperidone, in a 12-months,~     double-blind, parallel-group, randomized, placebo-controlled clinical trial. Thereby,~     relevant data on cannabidiol's antipsychotic potential will be gained.~   "
48902|NCT02926846|"~     This is a randomized controlled trial to evaluate whether a switch to intravenous antibiotics~     with adjunctive lavage can improve the outcome of severe peritoneal dialysis related~     peritonitis.~   "
48903|NCT02926833|"~     This is a phase 1-2, open-label study in subjects with refractory DLBCL, evaluating the~     safety and efficacy of axicabtagene ciloleucel, an autologous anti-CD19 chimeric antigen~     receptor (CAR) T cell therapy, in combination with atezolizumab, a humanized, monoclonal~     antibody that binds to PD-L1 and blocks interaction with the PD-1 and B7.1 receptors. The~     trial will be separated into two distinct phases designated as phase 1 and phase 2.~   "
48904|NCT02926820|"~     There is a paucity of investigation into effective interventions to enhance cognitive~     function and/or mitigate cognitive decline in individuals with Huntington disease (HD). This~     study targeted working memory (WM), which is the ability to actively hold information in the~     mind in order to perform complex mental tasks, given reports of WM dysfunction in patients~     with HD. The investigators examined the feasibility of conducting a 5-week WM training~     program (Cogmed). Patient adherence and treatment tolerance were assessed. In addition,~     preliminary evidence for the efficacy of this training program on targeted cognitive~     abilities was examined. Nine patients with pre-manifest or early stage HD underwent training.~     Patients were assessed before the intervention and one week after completion.~   "
48905|NCT02926807|"~     A total of 30 subjects with moderate to severe atopic dermatitis. Thirty subjects without AD~     matched for sex, age and coronary artery disease risk factor with the AD subjects will also~     be included. All subjects will undergo the following imaging procedures: a 18FDG-PET to~     quantify vascular inflammation in the ascending aorta and carotids and a MDCT to calculate~     the Agatston score. Skin and blood biomarkers will also be assessed.~   "
48906|NCT02926794|"~     Two hundred and ninety-three college students who reported drinking in the past month were~     randomly assigned to condition in a 2 (self-affirmation: values vs. control writing task) x 2~     (implementation intentions: formed vs. not formed) between-subjects factorial design.~     Participants first completed a self-affirmation or control writing task, then read an article~     describing the risks of drinking. Next, all participants reported their common drinking~     behaviors and contexts, and then selected two harm-reduction strategies making either general~     intentions to use the strategies or making implementation intentions to use the strategies.~     Alcohol consumption was measured 1 and 2 weeks after the experimental session.~   "
48907|NCT02926781|"~     Radiographic evaluation of the amount of bone height gain and clinical evaluation of the~     possibility of developing complications after transcrestal sinus floor elevation using drills~     and the conventional osteotome technique.~   "
48908|NCT02926768|"~     CK-101 is a novel, potent, small molecule tyrosine kinase inhibitor (TKI) that selectively~     targets mutant forms of the epidermal growth factor receptor (EGFR) while sparing wild-type~     (WT) EGFR. The purpose of the study is to evaluate the pharmacokinetic (PK) and safety~     profile of oral CK-101; to determine the maximum tolerated dose (MTD) and/or recommended~     Phase 2 dose (RP2D) of oral CK-101; to assess the safety and efficacy of CK-101 in previously~     treated NSCLC patients known to have the T790M EGFR mutation.~   "
48909|NCT02926755|"~     The goal of this study is to use three (3) different imaging techniques:Fractional Flow~     Reserve (FFR) allows precise measurement of blood flow in the arteries to the heart, and is~     more reliable than pictures alone to determine the significance of blockages in the heart;~     Near Infra-Red Spectroscopy-Intravascular Ultrasound (NIRS IVUS) provides information about~     the amount of lipid and cholesterol in the plaque, and plaque volume; and Optical Coherence~     Tomography (OCT) allows physicians to assess tears in the surface of plaque and plaque~     thickness; to evaluate high risk non-infarct-related coronary lesion in patients who have~     suffered a recent heart attack, underwent successful opening of the artery with a stent, and~     have blockages greater than or equal to 50% in one or more of the other arteries to the~     heart; and to correlate this findings with cardiovascular outcomes at 1 year.~   "
48910|NCT02926742|"~     This single site study evaluates the efficacy of ultrasound accelerated thrombolysis using~     EKOS Endovascular Device with a standard infusion of thrombolytics for treatment of PE~   "
48911|NCT02926729|"~     This research is studying a new investigative imaging instrument called a nonlinear~     microscope (NLM). A nonlinear microscope can produce images similar to an ordinary~     pathologist's microscope, but without first processing tissue to make slides. This study will~     determine if a NLM can be used to evaluate tissue during lumpectomy surgery for breast cancer~     in order to reduce the probability that standard pathologic examination of the specimen after~     the end of the operation will find close or positive margins, thus possibly requiring the~     patient to have additional breast surgery.~   "
48912|NCT02926716|"~     As the proportion of early gastric cancer has been steadily increased in Korea, so has~     function-preserving surgery. The function preserving surgery is characterized by the~     minimized extent of gastrectomy, so this implies that bilateral margins are getting shorter~     than those of standard gastrectomies.~      Currently, there is only one way to identify resection margin status in gastric cancer,~     'frozen biopsy'. However, it is labor-intensive and time-consuming procedure. In addition,~     the results rely on the pathologist's expertise, thereby it showed limitation of its~     accuracy; high false negative rate of signet ring cell carcinoma was reported in a previous~     study.~      Recently, many studies on magnifying endoscopy with narrow band imaging(NBI) demonstrated~     that this emerging technique is useful to identify the gastric tumor margin more clearly in~     vivo, compared with conventional indigocarmine chromoendoscopy. So it was hypothesized that~     NBI may allow reliable delineation of tumor and identification of resection margin status in~     the specimen after gastrectomy for gastric cancer.~   "
48913|NCT02926703|"~     The investigators compared the feasibility of serum creatine kinase and serum lactate~     concentration as diagnostic markers to distinguish between generalized tonic-clonic seizures~     (GTCS) and syncopes in clinical settings that require fast-action treatment, such as in the~     emergency departments.~   "
48914|NCT02926690|"~     The purpose of this study is to determine the maximum tolerated dose (MTD) of OTS167~     administered via oral capsule (PO) to patients with relapsed/refractory locally advanced or~     metastatic breast cancer.~   "
48915|NCT02926677|"~     This study is designed to examine three treatment conditions for traumatized youth:~     Cue-Centered Treatment (CCT), Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT), and~     Treatment as Usual (TAU) to determine which treatment works most effectively for which youth.~     The investigators would like to determine feasibility of training on the treatment~     interventions. In addition, this study aims to inform development of systems of care for~     chronically traumatized youth.~      The investigators hope to determine whether 1) TF-CBT and CCT will have better outcomes than~     TAU, 2) Child characteristics predict better outcome in either TF-CBT or CCT and to identify~     which phases of treatment are most effective, and 3) Imaging findings will be predictors of~     improved outcome. This research is important because while there are many existing trauma~     interventions for youth, little is known about what is most essential in those interventions.~     This study will shed light on what components of treatment are most effective. Furthermore,~     there are minimal guidelines on how to select the most appropriate intervention for a~     particular child. This study will contribute to that knowledge by informing which~     interventions are suited best for which youth.~   "
48916|NCT02926664|"~     The study will investigate the prognostic value of qSOFA (quick Sequential Organ Failure~     Assessment) kinetics between H0 and H1, and between H0 and H3 in patients with suspicion of~     Sepsis, i.e. an initial qSOFA of at least of 2.~   "
48917|NCT02926651|"~     As tranexamic acid (TXA) becomes more prevalent, all patients are receiving the same dose~     regardless of their pre-operative risk of transfusion. Therefore the aim of the study is to~     determine whether or not repeated dosing of oral TXA reduces the post-operative reduction in~     hemoglobin, hematocrit, number of transfusions, and post-operative blood loss following~     primary TKA and THA surgeries in patients with low pre-operative hematocrit and high risk for~     transfusion. The investigators hypothesize that a multi-dose TXA regimen will significantly~     minimize post-operative blood loss and transfusion requirements compared to the use of a~     single dose regime.~   "
48918|NCT02926638|"~     This randomized phase II/III compares rilotumumab when given together with erlotinib~     hydrochloride against erlotinib hydrochloride alone in treating patients with stage IV~     squamous cell lung cancer that has come back after previous treatment. This is a sub-study~     that includes all screened patients positive for the met proto-oncogene (MET)/hepatocyte~     growth factor (HGF) biomarker. HGF can interact with MET and can cause tumor cells to grow~     more quickly. Rilotumumab may decrease the activity of HGF and may be able to shrink tumors.~     Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. It is not yet known whether giving rilotumumab with erlotinib~     hydrochloride works better than erlotinib hydrochloride alone (standard treatment) in~     treating squamous cell lung cancer.~   "
48919|NCT02926625|"~     Fevers in childhood are common and usually self-resolve. In sub-Saharan Africa, when a~     febrile child presents to a community health worker (CHW), the child is assessed for malaria,~     pneumonia, and diarrhea, and other danger signs, according to WHO guidelines for integrated~     Community Case Management (iCCM) of childhood illnesses. In the cases where 1) there are no~     danger signs present, and 2) malaria, pneumonia, and diarrhea have been ruled out, the World~     Health Organization (WHO) recommends that all children be reassessed in 3 days. It is~     hypothesized that health outcomes for these cases will be equivalent if the CHW advises to~     come back in 3 days only if symptoms have not resolved. In order to assess this hypothesis, a~     two-arm cluster-randomized, community-based non-inferiority trial in Southern Nations,~     Nationalities and People's Regional State (SNNPR) in Southwest Ethiopia will be conducted to~     assess the non-inferiority of CHW-advised systematic follow-up on day 3 compared to~     conditional follow-up for non-severe febrile illness in children age 2 to 59 months, in which~     no cause of fever can be identified and where danger signs are absent.~   "
48920|NCT02926612|"~     This is a multicenter prospective collection of leftover respiratory tract secretions, paired~     blood and NP swabs, and clinical circumstances from pediatric HCT patients, followed by next~     generation genomic sequencing, transcriptome analysis, protein biomarker measurement, and~     statistical modeling.~   "
48921|NCT02926599|"~     Simulated environment allowed safe learning of critical events and knowledge of appropriate~     response and treatment. Anesthesiology resident education curriculum in Lyon plans several~     high fidelity simulation session with a large panel of critical events. Anticipation of~     critical events before they may occur and planification of team resources and priority in the~     treatment strategy may help to improve team performance during the scenario. The~     investigators' goal is to compare individual and team performances with or without an~     optimization personal potential training.~   "
48922|NCT02926586|"~     The purpose of the study is to determine whether Fludarabine in combination with cytarabine~     is more effective than high-dose cytarabine in post-remission therapy for patients with~     core-binding factor acute myeloid leukemia~   "
48923|NCT02926573|"~     Patient satisfaction with healthcare is increasingly being utilized as a metric to reflect~     provider and hospital quality of care. Furthermore, at the core of a healthcare team and~     healthcare system is the desire to provide patients with the best possible care in order to~     achieve the best possible outcomes. Providers have the duty to identify areas of needed~     improvement within the domains of treatment. An area of need that is ubiquitous within~     medicine is pain control; in this case acute postoperative pain control is the targeted~     condition. Studies have already shown that better control of acute postoperative pain leads~     to shortened hospital stays, reduced hospital costs and patient morbidity, improved patient~     satisfaction and a reduced likelihood of developing chronic pain. Research within the field~     of pain management has definitively revealed that a combination of different medication~     regimens can control acute postoperative pain better than narcotics alone. In particular, the~     medication gabapentin has been shown to improve acute postop pain in many kinds of surgical~     settings, and it is a safe medication with arguably fewer side effects than narcotics. The~     investigators know that certain groups of post surgical otolaryngology patients can be at~     risk for high levels of postoperative pain. Given all of this information, physicians have a~     responsibility to utilize medications such as gabapentin to do a better job of controlling~     patient's pain. This investigation is a quality improvement project designed to elucidate the~     benefits of gabapentin in pain management in patients undergoing surgery of the head and neck~     mucosal surfaces. It will provide much needed data in an understudied population and~     ultimately will improve the practice of pain management, patient satisfaction and quality of~     care delivered in the Barnes otolaryngology department.~   "
48924|NCT02926560|"~     The aim of this study is~      1) To describe the level and determinants of methotrexate adherence in patients with chronic~     inflammatory rheumatism (rheumatoid arthritis, spondyloarthritis and psoriatic arthritis) in~     the department of rheumatology in the Nîmes University Hospital~   "
48925|NCT02926547|"~     1. Identify the tissue proteins associated with early breast cancer invasion phases without~          lymph node involvement .~        2. Consider their role in the invasion and the risk of tumor spread .~   "
48926|NCT02926534|"~     The purpose of this study is to assess the prevalence of COPD among individuals aged 35 - 59~     years based results of spirometry before and after bronchodilator, presence of structural~     changes in lungs (emphysema, inflammatory changes and thickening of the walls of the large~     and small airways)detected by computer tomography as well as the symptoms of COPD. The study~     has three study groups: smokers of conventional cigarettes; those who had quit smoking 1 - 5~     years ago, and those who haven't smoked cigarettes.~   "
48927|NCT02926521|"~     The investigators' objective is to evaluate whether any of the various peripheral nerve block~     catheter dressing strategies currently employed by the Boston Children's Hospital Regional~     Anesthesia Service has any differential impact on specific outcome endpoints such as regional~     block catheter dislodgement, catheter occlusion, catheter leakage, skin irritation, and skin~     infection.~   "
48928|NCT02926508|"~     Recently, there has been an emerging interest in how manipulating gut microbiota (which is~     composed by microorganisms living in our digestive system) can influence learning, memory and~     cognition. This influence is thought to primarily occur via the gut endocrine and immune~     systems, and the vagus nerve, all of which influence brain function and are modulated by~     intestinal microorganisms. One way to manipulate the microbiota is to ingest dietary~     compounds, such as prebiotics.~      Prebiotics are non-digestible dietary fibres that enhance the growth of healthy bacteria in~     the intestines when given in adequate amounts. Prebiotics are relatively stable, can be~     stored at room temperature and can be easily added to foods or drinks. They are not degraded~     by enzymes and acids in the digestive tract; therefore they reach the colon relatively~     unchanged, where they are metabolised by specific bacteria, thus promoting their beneficial~     effects. Prebiotics can be found in very small proportions in vegetables and fruits such as~     leeks, onions, tomatoes, garlic, etc., but this naturally occurring quantity is generally~     insufficient to promote a significant growth of beneficial bacteria. Therefore, large~     quantities of purified prebiotics are available as powder supplements and sold in packages of~     the appropriate dose.~      Pre-clinical studies in animals have shown that prebiotics modulates brain expression of key~     molecules involved in cognition and brain health in rats. These findings therefore highlight~     the potential of influencing cognition through the manipulation of gut microbiota (in this~     case, via the ingestion of a prebiotic).~      Building on this evidence, the aim of this study is to investigate how manipulating gut~     microbiota can influence reading, learning and behaviour in a group of children whose reading~     scores suggest there is room for improvement.~   "
48929|NCT02926495|"~     Hypertension is a serious public health issue, affecting approximately 30% of adults.~     Hypertension greatly contributes to the risk for heart disease and stroke, both among the top~     three leading causes of death in the Americas, Europe, and Asia. While most treated~     individuals with hypertension are controlled on medication, diet and exercise, an estimated~     12% are resistant to conventional medical intervention. Alternative effective treatments are~     still needed for this hypertensive patient population to mitigate the risk and incidence of~     mortality and morbidity.~      This original Investigational Device Application is for a study intended to confirm the~     safety and efficacy of bilateral subcutaneous median nerve stimulation using the eCoin system~     to treat resistant hypertension. The eCoin device delivers electrical stimulation pulses to~     the median nerve from a small coin sized device placed under the skin of the distal anterior~     forearm. The implant delivers a weekly 30 minute treatment based on previous studies showing~     a long lasting and cumulative effect. The safety and efficacy of eCoin therapy has previously~     been demonstrated in a multinational, randomized, double-blind, sham-controlled study in New~     Zealand, Taiwan and Canada.~      This trial is a multi-center, prospective, double-blind, 1:1 randomized sham-controlled study~     of the safety and effectiveness of eCoin median nerve neuromodulation in subjects with~     drug-treatment resistant hypertension. The eCoin neuromodulation device will be implanted~     subcutaneously in the right and left forearms of patients with uncontrolled hypertension~     despite treatment with 3 or more antihypertensive agents. After a 4 week implant healing~     period, subjects will be 1:1 randomized into either a treatment or control group. One half of~     the subjects have their devices activated (treatment) and the other half undergo a sham~     activation (control) to maintain participant blinding to their treatment allocation. During~     the six months post-randomization, the eCoin is ON in the treatment group and OFF in the~     control group.~   "
48930|NCT02926482|"~     This is a cluster-randomized controlled trial designed to increase the availability of~     buprenorphine and extended-release naltrexone treatment capacity for opioid use disorder~     (OUD). The intervention being tested is a bundle of OUD pharmacotherapy capacity building~     practices called the Prescriber Recruitment Bundle (PRB). For the study, 70 organizations~     will be identified and recruited, and those organizations will then be randomized into one of~     two arms: 1) control, and 2) intervention: organizations implementing the PRB using the~     Network for Improvement of Addiction Treatment (NIATx) Organizational Change Model. The~     primary research question is to test the impact of the PRB, relative to the control, on~     increasing buprenorphine treatment slots and extended-release naltrexone capacity and the~     number of patients receiving these pharmacotherapies.~   "
48931|NCT02926469|"~     The purpose of the proposed study is to evaluate the feasibility of using immersive Virtual~     Reality (VR) during labor. We will also explore whether VR distraction is helpful for~     reducing subjective pain during labor, even if this pain is severe or excruciating. We~     predict that VR is feasible in this setting and that VR distraction will reduce acute pain~     and anxiety during labor.~   "
48932|NCT02926456|"~     The purpose of this study is to describe the effectiveness of darunavir/cobicistat~     (DRV/c)-based regimens, measured as maintenance of virological suppression 48 weeks after~     baseline, defined as the day when the treatment with DRV/c-based regimen is started, through~     collection of daily practice data in the Italian setting.~   "
48933|NCT02926443|"~     The shoulder is the most mobile joint in the body but still has the responsibility of~     ensuring a strong stability of our upper limbs during daily activities. The shoulder joint~     therefore requires a significant level of neuromuscular control at all times. The shoulder~     heavily relies on 4 key stabilizing muscles, known as the rotator cuff complex (RC). A~     tendinopathy of the RC may cause pain, significant muscle weakness, and a decrease in motor~     control of the shoulder during functional activities as well as work tasks. Individuals who~     have an RC tendinopathy often have neuromuscular and proprioceptive deficits. The objectives~     of this study are to evaluate the effectiveness of a brand new strength and motor control~     exercise program for the upper extremities and to compare the effectiveness of this program~     to usual physiotherapy care (such as manual therapy, motion exercises, strengthening, manual~     techniques) in reducing shoulder pain and improving overall function. A total of 44~     participants suffering from an RC tendinopathy will be recruited; 22 will be assigned to the~     exercise group (EXP) and 22 participants will be receiving usual physiotherapy care (CTL).~     Participants in the EXP group will partake in the new exercise program 3 times / week for 6~     weeks whereas participants in the CTL group will receive usual physiotherapy treatments twice~     / week with home exercises for 6 weeks. The results of this study will provide clinicians~     with a cost-effective and innovative treatment approach to treating shoulder pain. This study~     will provide active rehabilitation guidelines for reducing shoulder pain and the incidence of~     recurrence.~   "
48934|NCT02926430|"~     The purpose of this study is to assess the safety and tolerability of 2 single doses of~     either 5*10^10 viral particles (vp) or 1*10^11 vp of Ad26.RSV.preF, administered~     intramuscularly to elderly adults given approximately 12 months apart.~   "
48935|NCT02926417|"~     The IPOD-B2 Study aims to understand the pathogenesis of postoperative delirium in patients~     undergoing major surgery. The investigators will identify then correlate soluble biomarkers~     in blood and cerebral spinal fluid with changes in High Density-Electroencephalogram.~   "
48936|NCT02926404|"~     Retro-prospective study allowing inclusion of patients with spinal deformities treated by~     patient-specific rods (UNiD).~      This study aims to assess performance, clinical outcomes and safety~   "
48937|NCT02926391|"~     Multicenter study allowing to include the first sixty patients implanted with a custom-made~     corpectomy implant (UNiD 3D VBR): 30 patient implanted in cervical region and 30 patients~     implanted in thoracolumbar region.~      The main objective is to confirm feasibilty and safety of patient-specific implants for one~     or multi-level corpectomy and fusion.~      This study was approved in March 2016 allowing to include retrospectivley all patients since~     the first implantation in January 2015 and prospectively all patients after the approval.~   "
48938|NCT02926378|"~     Based on the evidence, a pre-post test pilot study design will be implemented to clarify the~     benefits of an acupuncture intervention before and after treatment. The initial assessment~     will contain a brief demographic interview and a review of medical records, and both pre and~     post-intervention evaluations will comprise an imaging protocol that includes RS-fMRI, pCASL,~     diffusion kurtosis imaging (DKI), and a brief cognitive assessment, as described in greater~     detail below. Several quantitative measures within DMN regions will be generated and compared~     between pre- and post-acupuncture therapy. These include 1) RS-fMRI measures such as~     connectivity strength and fractional amplitude of low frequency fluctuations (fALFF); 2)~     regional CBF measured with pCASL; 3) water diffusion measures for microstructural changes~     with DKI.~   "
48939|NCT02926365|"~     The purpose of this study is to test internet-delivered cognitive behavior therapy for~     children and adolescents with anxiety disorders and obsessive-compulsive disorder in a~     routine clinical setting in a rural part of Sweden.~   "
48945|NCT02926287|"~     Main objective is evaluation of success rate of ambulatory surgery (AS) for pelvic organ~     prolapse (POP). All surgical approaches (laparoscopic, vaginal) are included in the study.~      Secondary objectives are AS rate in the overall population and reasons for ineligibility or~     failure of ambulatory surgery.~      This pilot study will evaluate the feasibility of AS for POP and identify pitfalls in AS.~      A randomized control study will follow PCAP study.~   "
48946|NCT02926274|"~     Massive hemorrhage is a major cause of potentially preventable death following trauma. A~     common consequence of hemorrhagic shock is uncontrollable bleeding from coagulopathy, leading~     to death from exsanguination. Even when bleeding is controlled, patients are at increased~     risk of complications and mortality. Reconstituted whole blood, or component therapy with~     packed red blood cells (PRBCs), plasma, and platelets was introduced by the military in~     recent conflicts in Iraq and Afghanistan with remarkable results and has been adopted by most~     civilian trauma centers. Despite improving coagulopathy, it is apparent that transfusion of~     blood components is not equivalent to whole blood transfusion. Transfusion of high plasma~     volumes may be associated with increased risk of allergic reaction, transfusion associated~     acute lung injury (TRALI), hypervolemic cardiac failure, and acute respiratory distress~     syndrome (ARDS). Military services have recently reintroduced fresh whole blood (WB) for~     standard resuscitation of massive hemorrhage, have found that WB offers a survival advantage~     over component therapy, and that risks of transfusion reactions are similar for WB and PRBCs.~     On the civilian side, whole blood is an FDA-licensed product that has been in use in~     pediatric open heart surgery and autologous blood donation but is no longer commonly~     available for other indications. However, the military results are renewing interest in whole~     blood for trauma resuscitation. The use of low-antibody titer whole blood leukoreduced with a~     platelet-sparing filter was recently approved by the University of California Los Angeles~     Blood and Blood Derivatives Committee and two other trauma centers for male trauma patients.~     This study will test the feasibility of providing stored WB for resuscitation of patients in~     hemorrhagic shock and determine the effects of WB on clinical outcomes as well as the effects~     on coagulation, fibrinolysis, and inflammation, compared to standard blood component therapy.~   "
48947|NCT02926261|"~     Nutritional status in patients with cirrhosis has been shown to have a direct influence on~     the prognosis of these patients, it is related to higher mortality and it has been linked to~     the developement and perpetuation of certain complications such as hepatic encephalopathy,~     ascites and spontaneous bacterial peritonitis.~      Despite the importance of nutritional status in this patients, most of the methods for its~     assessment are still not completely reliable or not easily accessible; therefore, evaluating~     nutritional status in the daily clinical practice is still a complex task.~   "
48948|NCT02926248|"~     The specific aim of this study is to evaluate the effect of oral colchicine in primary TKA~     patients at 3 months following a manipulation under anesthesia.~   "
48949|NCT02926235|"~     The goal of this trial is to assess the efficacy of essential amino acids (EAA) on muscle~     atrophy and malnutrition compared to a placebo in patients following a total knee~     arthroplasty. The investigators specific objectives included analysis of (1) muscle strength,~     (2) change in malnutrition, (3) perioperative complications (4) physical activity.~   "
48950|NCT02926222|"~     This study aims to evaluate the role of Regorafenib in prolonging the overall survival of~     glioblastoma multiforme patients who progressed after surgery and Stupp regimen with or~     without bevacizumab.~   "
48951|NCT02926209|"~     This will be a prospective multi-center, multi-national comparative non-blinded clinical~     investigation. Each subject will undergo back-to-back tandem colonoscopies with the~     Aer-O-Scope Colonoscope System and a conventional colonoscope since this is a tandem~     colonoscopy study, each subject will serve as their own control. The 1st procedure will be~     randomized, half to Aer-O-Scope Colonoscope System and half to conventional colonoscope. The~     same investigator will perform both procedures on each subject. All pathologies found will be~     either removed or tattooed. Unmarked pathologies found on second pass will represent those~     missed during the 1st pass, thus making the subject and the control one and the same.~     Tattooed pathologies that can be removed endoscopically will be removed in an additional~     colonoscopy. This may occur if a large polyp cannot be removed for any reason with the~     Aer-O-Scope, but can be removed with conventional colonoscopy.~   "
48952|NCT02926196|"~     Phase III randomized trial of the anti-PD-L1 antibody avelumab as adjuvant or~     post-neoadjuvant treatment for high-risk triple negative breast cancer patients. The overall~     protocol-defined patient population will include the following two strata of patients:~        -  Stratum A - Patients who have completed treatment with curative intent including surgery~          of the primary tumor followed by adjuvant chemotherapy and (if indicated) radiotherapy.~        -  Stratum B - Patients who have completed treatment with curative intent including~          neoadjuvant chemotherapy followed by surgery of the primary tumor and (if indicated)~          radiotherapy.~   "
48953|NCT02926183|"~     Gemcitabine plus nub-paclitaxel (GA) regimen was recently presented at an international~     oncology meeting and represents a new standard regimen in the treatment of metastatic~     pancreatic cancer. Therefore, it was decided to consider the balance of safety and efficacy~     on survival time as a preoperative chemotherapy, the investigators use the NAC-GA regimen~     includes only two cycles (three times weekly and one week rest) of GA regimen.~   "
48954|NCT02926170|"~     Long-term anticoagulation is widely used for secondary thromboprophylaxis in the~     antiphospholipid syndrome (APS) due to the high risk of recurrent events. Currently~     anticoagulation with vitamin K antagonists (VKAs) is the standard of care but have~     unpredictable pharmacodynamic properties that requiere monitoring for dose adjustment.~     Rivaroxaban, an orally active direct factor Xa inhibitor, has been shown to be effective and~     safe compared with warfarin for the treatment of venous thromboembolism and non valvular~     atrial fibrillation in major RCTs. No studies had been published in APS.The aim of the study~     is to investigate the efficacy and safety of rivaroxaban in preventing recurrent thrombosis~     in patients with APS compared with acenocoumarol~   "
48955|NCT02926157|"~     The purpose of this study is to investigate whether a comprehensive group education combined~     with a lifestyle activation program that includes (a) sleep hygiene course, (b) physical~     activity promotion, and (c) bright light therapy, can improve both sleep quality and~     cognitive function among 96 community-dwelling older adults.~   "
48956|NCT02926144|"~     The main objective of this study is to compare the proportion of tracheal intubations for~     which more than one person is necessary when using the McGRATH® MAC videolaryngoscope.~   "
48957|NCT02926131|"~     This is an observational prospective study. The main purpose is to evaluate the stability of~     the Bilistick system in a humid and hot climate compared to the quantitative test for serum~     bilirubin (SBR) measurement currently used, the BR-501 total bilirubin meter, kept in a~     controlled environment.~      The secondary aim is to assess the operational feasibility of the Bilistick system in a~     tropical limited-resource setting, when used by locally trained nurses.~   "
48959|NCT02926105|"~     This study compares the effects of three home-based exercise programmes in at-risk to~     falling older adults living in their own home on the incidence of falls (number and~     severity), risk factors, and quality of life as well as on the adherence to exercise. The~     subjects will be randomized and allocated in three groups. The group A will receive the~     Test-and-Exercise home-based programme (T&E), the group B will receive the Otago~     home-based exercise programme and the group C (activ-control group) will receive the~     Helsana booklet~   "
48960|NCT02926092|"~     The purpose of this study is to gain an understanding of how adRP progresses over time in~     patients with misfolded rod opsin mutations.~   "
48961|NCT02926079|"~     This proposed study; Investigation of mechanisms for transmission of impaired glucose~     metabolism in infants exposed to diabetes in utero, will test the overarching hypothesis that~     impaired maternal substrate oxidation (metabolic inflexibility) and placental lipotoxicity~     are characteristics of diabetic pregnancies and in utero development within these conditions~     programs a metabolically inflexible phenotype in the offspring.~   "
48962|NCT02926066|"~     This clinical trial expansion is to offer patients, who are not enrolled into the Phase I/II~     trial, a chance of treatment, to extend the experience in this gene therapy, and to increase~     the dosage slightly to waive the drug dilution procedure.~   "
48963|NCT02926053|"~     Adoptive T cell therapy (ACT) with tumor infiltrating lymphocytes (TIL) has achieved~     impressive clinical results with durable complete responses in patients with metastatic~     melanoma. The TILs are isolated from patients own tumor tissue followed by in vitro expansion~     and activation for around 4-6 weeks. Before TIL infusion the patients receive 1 week of~     preconditioning chemotherapy with cyclophosphamide and fludarabine. After TIL infusion~     Interleukin-2 is administered to support T cell activation and proliferation in vivo.~      Recent studies suggest, that TIL therapy works in other cancers than Metastatic Melanoma,~     including Renal Cell Carcinoma. In this study TIL therapy is administered to patients with~     metastatic Renal Cell Carcinoma.~   "
48964|NCT02926040|"~     A. Pancreatic cancer background In 2012, 1,172 new pancreatic cancer patients were diagnosed~     in Switzerland. Only 20% of the patients with newly diagnosed pancreatic cancer are~     candidates for surgical resection, the only potential treatment for cure. Over 30% of the~     patients initially present with locally advanced disease. Patients with locally advanced~     disease have no evidence of metastatic spread to the liver, lung, and peritoneum but present~     with local involvement of vital structures that prohibits reasonable tumor resection.~     Currently, those patients are evaluated for palliative chemotherapy +/- radiation therapy.~     However, even with best conventional medical therapy, median survival of patients with~     locally advanced disease is mostly below 1 year. Over the last years, loco-regional therapies~     gained increased attention including radiofrequency-, cryo-, and microwave ablation as well~     as electrochemotherapy. However, all those entities are criticized by their complication~     rates leading to morbidity and mortality, limited area of application given the complex~     anatomical structures around the pancreas, and ill-defined improvements in overall survival.~      B. Irreversible electroporation (IRE):~      Irreversible electroporation is an emerging ablative modality that gained enormous interest~     over the last five years. For locally advanced pancreatic cancer, it was introduced in 2009.~     IRE is mainly non-thermal and primarily works through apoptosis. Its well studied safety~     profile allows ablation also within the context of locally advanced pancreatic cancer given~     it mainly spares vessels from destruction.~      Increasing evidence shows that IRE for locally advanced, unresectable pancreatic cancer is~     effective compared to historic controls with a significant prolongation of local progression~     free survival, distant progression free survival and overall survival. The improvement in~     overall survival is about double the amount of what is seen with best new chemotherapy and~     chemoradiation regimens used at the present time. Those results are even more impressive~     given the discouraging improvements among palliative systemic options.~      The NanoKnife IRE device (Angiodynamics, Queensbury, NY) is commonly used to perform IRE~     procedures in pancreatic cancer patients and is commercially available since 2009 and got~     Food and Drug Administration (FDA) 510K clearance for soft tissue ablation in October 2011 in~     the United States.~      C. Quality of life and nutritional status/long term outcomes Given the overall poor long-term~     outcomes of patients with pancreatic cancer, health-related quality of life (HRQoL) measures~     are of utmost importance when treatment recommendations are discussed with patients. This is~     especially true for patients with more advanced staged disease where definitive surgical~     resection with curative intent is not possible. However, HRQoL reports for patients with~     locally advanced pancreatic cancer undergoing IRE are very limited. To the best of the~     investigators' knowledge, no other specific investigations exist that assessed HRQoL measures~     for patients undergoing IRE for locally advanced pancreatic cancer, no specific assessment~     exists that focuses on nutritional status for this patient group. In addition, impact on~     local and distant recurrence as well as cancer-specific and overall survival are still~     ill-defined and further information is needed.~   "
48965|NCT02926027|"~     Effect of Vascepa on Progression of Coronary Atherosclerosis in Persons with Elevated~     Triglycerides (200-499) on Statin Therapy. The study is to determine progression rates of low~     attenuation plaque under influence of Vascepa as compared to placebo.~   "
48966|NCT02926014|"~     The aim of this research was to evaluate the lingual tonsil hypertrophy (LTH) grading of~     patients with dysphagia using videolaryngoscopy and determine the relation of LTH grades to~     sociodemographic factors and clinical symptoms.~   "
48967|NCT02926001|"~     The purpose of this study is to evaluate formally the short term impacts of the tax policy~     applied to Sugar-Sweetened Beverages (SSBs) in Chile. The Impuesto Adicional a las Bebidas~     Analcohólicas (IABA, or additional tax on soft drinks) in Chile was enacted in October~     2014, affecting any non-alcoholic beverages to which colorants, flavourings or sweeteners~     have been added. For beverages above an added sugar concentration of at least 6.25 grams per~     100ml (or equivalent proportion), the tax was increased from 13% to 18%, while for those~     below this threshold the tax was decreased to 10%, producing an 8% tax difference between~     these beverage groups. This impact evaluation analysis of the Chilean sugar-sweetened~     beverage (SSB) tax will estimate the impact of increasing the tax as well as decreasing the~     tax on soft drinks. The study will use household level grocery purchasing data for Chile. The~     purchasing records are available from October 2011 to September 2015 (three years before; and~     one year after the implementation of the tax in October 2014). The investigators will use a~     series of quasi-experimental approaches to evaluate the causal impact of the SSB tax policy~     on consumers' behaviour as well as on industry responses in the form of pricing and price~     promotion decisions.~   "
48968|NCT02925988|"~     Over the past decade, technical advances have improved the efficiency of continuous EEG~     recording and remote review, leading to a steep increase in the number of continuous EEGs~     performed, and to an emerging change in what is considered the standard of care with regards~     to brain monitoring. Critically ill patients are at high risk for CNS insults, which can~     result in permanent neurologic disability if untreated. Non-convulsive status epilepticus and~     other secondary brain injuries are often unrecognized without continuous EEG monitoring.~     There is increasing evidence that continuous EEG monitoring facilitates early identification~     and management of changes in brain function, and a recent consensus statement concludes that~     each center should provide critical care continuous EEG at the highest level that local~     resources allow. Neonatal neuro-intensive care is a rapidly developing field with a focus on~     monitoring of the developing brain. Without continuous EEG monitoring, neonates with~     paroxysmal events that are suspicious for seizures are treated with phenobarbital, often for~     many months, with inherent risks of side effects. Because paroxysmal events in neonates may~     or may not represent seizures, and electrographic seizures may have no discernable clinical~     correlate, this approach fails to adequately diagnose seizures and exposes neonates to~     possible harm, either by medication overuse for paroxysmal events that have no electrographic~     correlate, or by under-treatment of seizures without clinical manifestations.~     Amplitude-integrated EEG technology is now increasingly used as a simplified monitoring~     method, using fewer numbers of electrodes and usually being interpreted by a neonatologist or~     trainee. This model has been implemented at the investigators NICU. However, a recent~     systematic review came to the conclusion that amplitude-integrated EEG has relatively low and~     variable sensitivity and specificity, and therefore should not be the mainstay for diagnosis~     and management of neonatal seizures. Continuous video EEG monitoring is recommended as the~     gold standard for critically ill neonates, but is a very expensive and resource-intense~     method. An approach combining both techniques in a standardized algorithm may provide~     improved patient care in a resource-restricted environment. The investigators are planning to~     test this hypothesis in a pilot project.~   "
48969|NCT02925975|"~     The aim of this study is to investigate the possibilities of early and precise management to~     decrease portal vein pressure in cirrhotic patients, guided by a non-invasive~     3D-virtual-model of hepatic portal system (3D-vHPS). Healthy volunteers are enrolled to~     determine the normal range of pressure density in different sites of HPS. Cirrhotic patients~     without visible gastro-esophageal varies by endoscopy are randomly enrolled to virtual portal~     vein pressure gradient (vPVPG) monitored or non-vPVPG monitored groups. Non-vPVPG groups are~     followed-up and treated according to Baveno V consensus in portal hypertension. Patients in~     vPVPG-monitored groups are followed-up by anatomic computed tomographic angiography (CTA) and~     Doppler ultrasound every six months. Once vPVPG is above 12mmHg, participants will receive~     carvedilol treatment. All cirrhotic patients are followed-up with the incidence of portal~     hypertension-related complications, mortality rate and life quality assessment.~   "
49004|NCT02925507|"~     It is the purpose of this study to determine if a commercially available electronic~     stethoscope synchronized with an smart phone or iPad application can be used as an accurate~     and objective screening tool for measuring dysphagia. The investigators plan to do so in two~     phases; in Phase I the investigators will recruit normal subjects to establish normal~     swallowing patterns, as well as optimal sensor placement; and in Phase II the investigators~     will compare the recordings obtained by the electronic stethoscope with those obtained using~     videofluoroscopy.~   "
48970|NCT02925962|"~     The investigators propose a three-arm, pragmatic, cluster-randomized clinical trial based in~     primary care. Participating Primary Care Providers (PCPs) will be randomized to usual care or~     one of two intervention arms. The first intervention will evaluate the efficacy of an~     automated CDSS that utilizes the electronic health record (EHR) to facilitate triple marker~     test ordering, guideline implementation and BP management, compared with usual care, among~     patients with previous documentation of eGFRcreat <60 ml/min/1.73m2. The second intervention~     goes a step further, and will evaluate whether a CDSS plus a follow-up telephone call from a~     pharmacist (CDSS PLUS) can improve BP management and patient CKD and NSAID toxicity knowledge~     among the patients with CKD, compared with CDSS alone. The primary clinical outcome is BP~     level, with secondary outcomes related to processes of care and patient knowledge.~   "
48971|NCT02925949|"~     This is a randomized controlled trial of a new behavioral intervention designed to improve~     engagement in HIV care for same-sex male couples. Investigators will compare the HIV viral~     load outcomes of couples randomized to a couples-based adherence intervention (DuoPACT) or to~     an individual adherence intervention (LifeSteps).~   "
48972|NCT02925936|"~     Compare the radiation in pediatric patients thyroid submitted to chest X-ray using the~     position of the anode and cathode.~   "
48973|NCT02925923|"~     The purpose of this study is to compare the inhibition of platelet aggregation (i) ticagrelor~     and bivalirudin/heparin versus (ii) clopidogrel, eptifibatide and heparin in patients with~     unstable angina undergoing coronary intervention.~   "
48974|NCT02925910|"~     Two groups of randomised rehabilitation patients will try a softwheels wheelchair and a~     regular one. One group will start with the softwheelsl and then change to the regular, and~     the other will start with the regular and then change to the softwheel.~   "
48975|NCT02925897|"~     The prevalence of people living with problems due to a long-term condition (LTC) such as~     heart disease, diabetes or arthritis in England exceeds 15 million, and the number of those~     with more than one LTC continues to grow (LTCs). This population consumes a large proportion~     of health service resources. Advancing age and LTCs increase the likelihood of becoming~     housebound, this has a detrimental effect on health and quality of life. Health policy~     advocates a health service model of empowerment and self-care. People who live with LTCs are~     often very knowledgeable about how to look after their health but find it difficult to adjust~     their.~      Motivational techniques have been demonstrated to facilitate behaviour change through~     changing the style of communication from directive to collaborative. The use of~     patient-centred conversational style of communication has been shown to elicit more~     willingness to change than professional-led directive consultations. Community nurses are in~     a unique position to influence housebound patients to play a greater part in caring for~     themselves, preventing complications in their long-term conditions and further ill health.~      This study intends to test the feasibility and acceptability of training community nurses in~     Understanding Behaviour Change, a communication technique which uses motivational~     interviewing to guide patients to change their behaviour. The opportunistic use of~     motivational techniques to create participatory relationships between patients, community~     nurses potentially represents an effective intervention to enable patients with LTCs to~     optimise the way they care for themselves.~      Motivational interviewing techniques have been widely demonstrated to bring about behaviour~     change but have not been studied in the context of changing the style of communication~     between housebound patients and the professionals caring for them.~   "
48976|NCT02925884|"~     The proposed study aims to test if Gunnar computer glasses provide any advantages, in~     comparison to no glasses, on the following aspects in computer-related office work:~        -  Any enhancement on visual performance of basic visual function, including visual acuity,~          contrast sensitivity, color discrimination, etc.~        -  Any enhancement on visual performance of typical office work, including reading,~          word-spelling check, number searching, or target identification.~        -  Any benefit in objective viewing comfort measured with viewing distance, blink~          frequency, post-viewing pupil size.~        -  Any benefit in subjective viewing comfort reflected on the questionnaire of viewing~          symptom survey.~        -  Any benefit in viewing comfort and visual performance with increased environmental~          ventilation or under strong glare.~        -  Any benefit in life quality from daily wearing (e.g., better comfort or sleep quality).~   "
48977|NCT02925871|"~     There is strong evidence that early supported discharge and continued rehabilitation at home~     (ESD) delivered by an interdisciplinary team reduces deaths or dependency in activities in~     daily living after stroke. Despite recommendations in national guidelines ESD is only~     implemented in few places in Sweden. There are interdisciplinary teams that supply~     rehabilitation in the home but the coordinated transition is lacking. Such rehabilitation is~     not evidence based. The key components of a coordinated transition to achieve the benefits of~     ESD are not known. The aim is to design, implement and evaluate new person-centred~     transitions between stroke units and the home to achieve full ESD. The development of~     person-centred transition will be performed together by people with stroke, significant~     others, stroke unit staff and interdisciplinary teams.~      Phase 1, a prospective observational study of current transitions from stroke units to~     rehabilitation in the home without coordination. The aim is to identify factors that are~     facilitators or barriers to transitions, patient and caregiver outcomes, use of health care~     during the first year after stroke. In phase 2, a co-design process of new person-centred~     transitions will be carried out by people with stroke, significant others, stroke unit staff~     and interdisciplinary home rehabilitation teams. In phase 3 new person-centred transitions~     will be implemented to form a full ESD service and evaluated in a cluster randomised~     controlled trial.~   "
48978|NCT02925858|"~     Randomized, controlled, double-blind pilot study evaluating the effect of an intraoperative~     infusion of intravenous Ketamine on the quantity of opioid consumed postoperatively in~     coronary artery bypass surgery patients receiving a median sternotomy.~   "
48979|NCT02925845|"~     -  Objective: To analyze the effect of neuromuscular electrostimulation in the maturation~          of radiocephalic arteriovenous fistula (RC-AVF) patients with chronic kidney disease~          (CKD) stage 5-5D~        -  Design: Clinical Trial with medical devices, 18-month, single-center, within the~          hospital setting.~        -  Disease or disorder study: vascular Access maturation.~        -  Population: Patients with CKD stage 5-5D at the research center.~        -  Project duration: 78 weeks~        -  Methodology:~        -  Patients with CKD stages 5-5D that has undergone a native AV in service stations to give~          their informed consent and meeting the inclusion criteria will be included.~        -  At baseline two study groups were established:~             -  Group 1: neuromuscular electrostimulation~             -  Group 2: isometric exercises~   "
48980|NCT02925832|"~     Deep topical fornix nerve block anaesthesia is now a known form of nerve block for cataract~     surgeries by phacoemulsification. In this study the investigators intend to compare~     ropivacaine and bupivacaine in various parameters during phacoemulsification.~   "
48981|NCT02925819|"~     The objective of this study is to collect in a prospective registry all cases of French~     patients undergoing an assessment for percutaneous treatment of mitral valve disease on a~     native valve or due to deterioration after surgical valve repair or replacement. In these~     patients, valvular surgery should be considered contra-indicated or at prohibitive risk. This~     registry will evaluate the morbidity and mortality up to 24 months for those patients with~     severe mitral valve disease who are not included in a clinical trial. The association of~     demographic, clinical, laboratory, echocardiographic variables and treatment options with~     morbidity and mortality will be evaluated by univariate and multivariate analyses.~   "
48982|NCT02925806|"~     A drug utilization study will be performed to describe trends in the number of prescriptions~     and patients for class REMS ER/LA opioids and comparator products.~   "
48983|NCT02925793|"~     The purpose of this randomized, double blind, placebo controlled, parallel group study is to~     compare the safety and efficacy of topically applied DS107 cream (1% and 5%) versus vehicle~     cream, in the treatment of adult patients with mild to moderate Atopic Dermatitis.~   "
48984|NCT02925780|"~     Clinical trial to investigate the clinical efficiency of resin infiltration technique for the~     improvement of dental fluorosis.~   "
48985|NCT02925767|"~     A randomized controlled non-inferiority trial based on split-body was planned to compare the~     efficacy of 308-nm excimer laser and 311-nm Ti:Sapphire laser in patients with vitiligo.~   "
48986|NCT02925754|"~     Pain catastrophizing is conceptualized as a negative cognitive-affective response to~     anticipated or actual pain and has been associated with a number of important pain-related~     outcomes.~      The aims of this study are~        1. To describe the characteristics of the patients and determinants of catastrophizing in~          chronic painful patients hospitalized in rheumatology in the Nîmes University Hospital~        2. To describe the impact of the catastrophizing on the level of insomnia and the drugs~          consumption in chronic painful patients hospitalized in rheumatology in the Nîmes~          University Hospital~   "
48987|NCT02925741|"~     This study will use a traditional cluster randomized crossover design with patients in five~     medical intensive care units at the Cleveland Clinic to evaluate the efficacy of silk-like~     bed sheets and underpads for prevention of Unit-Acquired Pressure Ulcers (UAPU). Adult~     hospitalized patients in beds with standard bed linens versus those with silk-like linens~     will be compared for 1) rate of development of UAPU, 2) time to develop the first UAPU, and~     the maximum severity of any UAPU that develop. Bed linens will be changed per unit protocol.~     Patient characteristics will be summarized using frequencies and percentages for categorical~     factors and means, standard deviations, percentiles and median and range for continuous~     measures. For the primary outcome of unit-acquired pressure ulcer rate, generalized linear~     mixed models, assuming a Poisson distribution for the outcome, and unit length of stay as an~     offset will be used. For the time to event analysis, frailty models will be used to assess~     whether time to first pressure ulcer differs between treatment types. Generalized linear~     mixed models will be used for other secondary endpoints, including maximum severity of~     observed pressure ulcers~   "
48988|NCT02925728|"~     The undernourishment and the prevention of its risk at the elderly person in seniors's~     resident represent a major issue in public health. The diagnosis of undernourishment and its~     risk are systematically recommended in these structures where the nutrition of these people~     is a problem because often inappropriate for their capacities of prehension and consequently~     for their nutritional needs. One of the solutions to remedy can be found in the  finger-food~     .~      The study FIFO (Finger-Food) suggests verifying the hypothesis which the finger-food would~     allow to increase the nutritional intake of the resident who have disorders of the prehension~     and\or requiring a nutritional stimulation and\or require an help to the preparation of the~     meal.~   "
48989|NCT02925715|"~     Comparison of two techniques of central venous cannulation of subclavian vein using~     ultrasound was performed. ultrasound guided central venous cannulation is the standard~     practice today but its use in subclavian vein is technically challenging and not much~     literature is available. In this study 96 Patients were randomized into one of the groups and~     compared for various outcomes. The primary outcome studied was the time taken for procedure.~     Secondary objectives included comparison of total access time using both the~     techniques,comparison of first attempt success rate, comparison of the quality of needle~     visualization and the comparison of immediate (mechanical) and delayed complication rates.~   "
48990|NCT02925702|"~     PRORADIUM is a prospective multicentre study to analyze circulating and tissue biomarkers~     that may predict prognosis and response in patients with CRPC treated conventionally with~     Radium-223.~   "
48991|NCT02925676|"~     To evaluate the technical performance of the hyposafe H02 during everyday activities and~     during insulin-induced hypoglycaemia, in addition to safety issues associated with the~     implantation and use of the hyposafe H02 in subjects with type 1 diabetes.~   "
48992|NCT02925663|"~     The purpose of this study is to establish the feasibility, accessibility, acceptability, and~     preliminary efficacy of an individually-tailored intervention to improve EF in adolescents~     with epilepsy (EFI-E).~   "
48993|NCT02925650|"~     This study evaluates the safety and pharmacological effects of 3 different doses of Posiphen®~     when compared to a placebo, in adult male and female patients with early Alzheimer's disease~     (AD).~   "
48994|NCT02925637|"~     To develop and assess the effectiveness of a novel cognitive-functional intervention (FACoT)~     in occupational therapy for people after mild to moderate stroke.~   "
49005|NCT02925494|"~     This is an extension study for women who have already received six months of treatment in the~     phase III clinical trial M12-815 or M12-817, and will evaluate the long-term efficacy and~     safety of elagolix administered alone and in combination with estradiol/norethindrone acetate~     for an additional six months in the treatment of heavy menstrual bleeding associated with~     uterine fibroids.~   "
49048|NCT02924935|"~     This study evaluates the role of histidine in patients with HARS Syndrome. Children with HARS~     Syndrome will receive oral nutritional supplementation with histidine at a dose which will be~     increased in the event of acute febrile illness. Vision, hearing and plasma biomarkers will~     be monitored throughout the study period.~   "
48995|NCT02925624|"~     Title: CLOSE-guided pulmonary vein isolation (PVI) as Cure for Paroxysmal Atrial Fibrillation~     ('CLOSE to CURE' study)~      Design: This is a prospective, observational, single-center, unblinded, clinical 3-year~     study.~      Background: In a population of paroxysmal atrial fibrillation (AF) 'CLOSE'-guided PVI, a new~     approach to obtain single-procedure durable PVI, has been shown to virtually eliminate~     recurrence of AF at 1 year follow-up with repetitive but discontinuous Holter monitoring.~      Objectives: (1) To objectively compare atrial tachyarrhythmia (ATA) burden before and after~     'CLOSE'-guided based PVI using continuous monitoring. (2) To assess ATA burden using~     continuous monitoring up to 3 years after ablation. (3) To identify baseline structural and~     electrical properties of the atria or procedural characteristics that predict 1-year and~     3-year outcome.~      Enrollment: Up to 100 subjects will be enrolled in this observational, prospective study.~      Clinical Sites: 1 site.~      Subject Population: Eligible patients are patients with paroxysmal high-burden AF who are~     planned for a 'CLOSE'-guided PV isolation. At the time of procedural planning we will ask the~     patient his/her consent for (1) implantation of a subcutaneous continuous loop recorder~     (sCLR), (2) a concise electrophysiological study at the time of PVI, (3) a transthoracic~     echocardiogram at the time of PVI and (4) collection of data during 3 years. Anti-arrhythmic~     drug treatment (ADT) and oral anticoagulation (OAC) will be given according the updated 2012~     European society of Cardiology (ESC) guidelines on AF (Camm et al, European Heart Journal~     2012) and the 2012 Heart rhythm society (HRS)/European Heart Rhythm association/European~     cardiac arrhythmic society Expert Consensus Statement on catheter and surgical ablation of~     atrial fibrillation (Calkins et al, Heart Rhythm 2012).~   "
48996|NCT02925611|"~     Postoperative delirium (POD) is a known complication of inhalational agents used to~     anaesthetise patients for surgery with potential long term implications.The incidence of~     postoperative delirium in spine surgery is 3.3% to 3.8%.The purpose of this study is to~     compare the occurrence of postoperative delirium with inhalational anaesthetics namely~     isoflurane and desflurane in spine surgery patients.~   "
48997|NCT02925598|"~     The standard procedure used for airway control in general anesthesia for LC (laparoscopic~     cholecystectomy) is endotracheal intubation (EI). AuraGain and I-Gel are supraglottic airway~     devices (SADs) used for airway control for certain types of surgeries. The aim of this study~     was to evaluate and compare the performances of new types of SADs with EI regarding their~     insertion times, durations, perioperative complications and effects on hemodynamic parameters~     and peak airway pressures (Paw) in LC as well.~   "
48998|NCT02925585|"~     The investigators will analyze biomechanical transformation of pelvic floor tissues and~     support structures under affected pelvic floor conditions and repaired states after the~     surgery.~   "
48999|NCT02925572|"~     Nowadays, eccentric exercise can be realized in a dynamic way with an ergocycle which permits~     eccentric (ECC) lower limbs contractions at a defined power output. With this type of~     ergometer, O2 consumption (VO2) in ECC is three fold lower than in concentric (CON) for the~     same power output. Consequently, ECC program could be used in chronic disorders with limited~     capacities, such as obesity.~      The investigators hypothesis that an eccentric training program, as it will induce higher~     mechanical constraints, would improve body composition, especially by reducing fat mass. This~     effect could be explained by an increased rest energy expenditure and a better improvement in~     biological parameters (particularly lipid profile and insulin-resistance) after ECC training~     (versus CON training).~      This study aims to compare the modification of fat mass after an ECC program versus a CON~     program at the same VO2.. The secondary goal is to assess the physiological mechanisms~     involved in the modification of body composition.~   "
49000|NCT02925559|"~     Objectives~      Primary objective:~      To access the change from baseline to week 12 in MAGE index of glycemic variability measured~     by CGMS for dapagliflozin versus. gliclazide MR.~      Secondary objectives:~        1. Change from baseline to week 12 in glycated hemoglobin A1c (HbA1c), fasting plasma~          glucose, postprandial glucose and achievement of HbA1c ≤6.5% and <7% at the end of the~          study) for dapagliflozin versus gliclazide MR.~        2. Change from baseline to week 12 in glycemic variability defined by the interquartile~          range (IQR - interval between 25th and 75th percentiles) measured by CGMS for~          dapagliflozin versus gliclazide MR.~        3. Change from baseline to week 12 in glycemic variability measured by the Standard~          Deviation of the mean glycemia (SD) measured by CGMS for dapagliflozin versus gliclazide~          MR.~        4. Change from baseline to week 12 in glycemic variability measured by the Coefficient of~          Variation (CV) measured by CGMS for dapagliflozin versus gliclazide MR.~        5. Change from baseline to week 12 in the time spent on hypoglycemic range (glycemia~          <70mg/dL) measured by CGMS for dapagliflozin versus gliclazide MR.~      Study design This is a single-center, prospective, randomized, open-label, comparative, phase~     IV study to compare the effects of gliclazide MR and dapagliflozin on Glycemic Variability in~     patients with Type 2 Diabetes Mellitus (T2DM). All patients should be treatment naïve or~     receive standard of care therapy for T2DM as well as for co-morbidities based on accepted~     guidelines and local best practices.~      Target patient population Approximately 120 patients with T2DM will be randomized from study~     site. Patients who were treated with metformin only and had inadequate glycemic control at~     the time of enrollment as well as treatment naïve or non-medically treated (e.g., diet)~     patients, will be enrolled and receive either dapagliflozin 10mg qd or comparator gliclazide~     MR 120mg qd in addition to standard of care treatment for T2DM and co-morbidities.~      Investigational product, dosage and mode of administration Dapagliflozin 10mg tablets~     administered orally once daily for 12 weeks.~      Comparator, dosage and mode of administration Gliclazide MR 60mg tablets administered orally,~     2 tablets once daily for 12 weeks.~      Duration of treatment The treatment with study medication or comparator will have a total~     duration of 15 weeks.~   "
49001|NCT02925546|"~     GSK2798745 is being developed as a novel therapeutic intervention for the treatment of~     pulmonary edema associated with heart failure (HF) and is currently under investigation in~     the form of a compounded capsule. This is an open-label, randomized, single-dose, crossover~     study with the purpose to determine the pharmacokinetics (PK) of three 2.4 milligrams (mg)~     tablet formulations of GSK2798745 in 12 healthy subjects. The three formulations developed~     for this study will be micronized GSK2798745 active pharmaceutical ingredient (API) (Tablet~     A), micronized GSK2798745 API with sodium lauryl sulfate (SLS) and hypromellose (Tablet B),~     milled GSK2798745 API with SLS and hypermellose (Tablet C), and Tablet D, which will be~     either A/B/C based on interim PK analysis of data from the first three treatment periods.~      Following a 30-day screening period, subjects will be randomized to one of the 6 treatment~     sequences: Treatment sequence 1: ABCD, 2=CABD, 3=ACBD, 4=BACD, 5=BCAD, 6=CBAD over three~     4-day treatment periods. For treatment period 4, the best formulation based on the interim~     analysis data from the three treatment periods will be evaluated under fed conditions. Each~     treatment period will be separated by a minimum of 7 (+14)-day washout period. The total~     duration of participation in the study will be approximately 11 weeks including the follow-up~     visit.~   "
49002|NCT02925533|"~     This research study is studying a combination of two experimental drugs as a possible~     treatment for Bladder Cancer that recurred after treatment with standard therapy, or Bladder~     Cancer that got worse while on treatment with standard therapy.~      The following interventions will be involved in this study:~        -  B-701~        -  Pembrolizumab~   "
49003|NCT02925520|"~     This is an expanded access study to assess the safety profile and changes in serum direct~     bilirubin levels in infants with PN associated cholestasis. Eligible patients will receive~     therapy with Omegaven on an expanded access basis by method of continuous infusion. Omegaven~     will be infused intravenously through either a central or peripheral catheter in conjunction~     with parenteral nutrition. The same standards of care provided to all patients receiving~     parenteral nutrition solution will be followed.~   "
49595|NCT02917759|"~     Patients having surgery to remove a liver or biliary tissue mass or having a biopsy of a mass~     or lesion will have a tissue sample collected and stored for future research of liver and~     biliary diseases. A blood sample may also be collected at the time of enrollment.~   "
49006|NCT02925481|"~     Each year more than 26,000 pregnancies in the United States end in stillbirth (late fetal~     death at >20 weeks of gestation). A 2011 issue of the Lancet, dedicated entirely to~     stillbirth, recognized it as a too-often-ignored public health problem despite occurring~     once in every 160 pregnancies. The death of a baby is highly traumatic and can incite~     negative mental, emotional, and physical health consequences lasting years after the loss.~     Bereaved mothers with stillbirth have a 4-fold higher risk of depression and 6-fold higher~     risk for post-traumatic stress disorder (PTSD). These mental health consequences are likely~     to negatively affect subsequent pregnancies, many of which occur within the first year after~     loss (50-98%).~      Inter-conception care is provided to women of reproductive age between pregnancies; however,~     few interventions focus on PTSD symptomatology and its related comorbidities in bereaved~     mothers. Treatment for bereaved mothers may include psychiatric medication and/or referral to~     support groups. Because bereaved mothers with stillbirth may have additional mental and~     physical health risks, pharmacological interventions are typically a first and sole line of~     treatment and may not sufficiently allay bereaved mothers' emotional distress. Moreover,~     women may be trying to conceive or may have already conceived and report reticence to taking~     medication. Additionally, support groups with little emphasis on coping may not be helpful~     for some grieving mothers.~      Non-pharmacological approaches, such as yoga, may be an alternative option for bereaved women~     with stillbirth. Yoga has been established as an effective, safe, acceptable, and cost~     effective approach to improving mental health in a variety of populations, including pregnant~     and post-partum women. Yoga has also been used as a means to cope with PTSD associated with~     surviving a traumatic event (i.e., interpersonal violence, military veterans). We are unaware~     of any studies that have explored yoga to reduce PTSD in bereaved mothers with stillbirth.~     Furthermore, online streaming yoga (on-demand videos played in the home) has recently grown~     in popularity and may address the unique barriers that women experiencing stillbirth may~     have. To reduce PTSD symptoms and its co-morbid conditions (i.e., anxiety and depression) we~     propose to develop and test the feasibility and acceptability of a home-based, online~     streamed yoga intervention (www.udaya.com) for bereaved mothers with stillbirth.~   "
49007|NCT02925468|"~     The correction of a deep overbite is assumed to involve incisor intrusion and the extrusion~     or eruption of premolars and molars. The latter is also assumed to be the major contributor~     for growing patients where the vertical facial growth increase accommodates for the~     additional eruption of posterior teeth with anterior bite plane appliances.~      In this study the nature and rate of adaptation of the occlusal changes following insertion~     of a fixed anterior bite plane for the reduction of a deep overbite in growing patients will~     be investigated.~   "
49008|NCT02925455|"~     This is a pilot randomized controlled trial of an intervention to improve arm function in~     children ages 6 to 17 with cerebral palsy and upper limb hemiparesis. Twenty participants~     will be randomized to either a group treated with neuromuscular electrical stimulation and~     video games or video games alone. Both groups will receive 6 wks of treatment consisting of~     home and lab sessions. Both the experiment group and control group interventions consist of~     therapist-guided sessions in the rehabilitation clinic and self-administered or~     caregiver-assisted sessions at home. While both groups will receive the same task practice~     and video game training, only the experiment group will receive an electrical stimulation~     device to assist with hand opening during practice. Changes in upper extremity motor~     impairment and function will be assessed for each participant at baseline, mid treatment, end~     of treatment and at 3 mo follow-up.~   "
49009|NCT02925442|"~     Three primary reasons prolong hospital stays following unilateral knee arthroplasty. Pain is~     the primary reason followed by opioid drowsiness and nausea/vomiting side effects. Standard~     genicular radiofrequency ablation (t-RFA) has been effective pain management for~     non-operative knee pain associated with osteoarthritis. Additionally, cooled radiofrequency~     ablation (C-RFA), is now available for knee pain management. Both t-RFA and C-RFA offer~     minimally invasive, non-surgical, non-opioid pain relief options following surgery. The study~     will perform a double-blinded, parallel grouped, placebo-controlled randomized study to~     compare three pain management paradigms involving preoperative genicular C-RFA, t-RFA, and~     control placebo/sham. The aim of this study is to establish if C-RFA and t-RFA, offered~     preoperatively to patients undergoing unilateral knee arthroplasty, provide postoperative~     pain relief.~   "
49010|NCT02925429|"~     PostNAPs was a continuation of the PreNAPs study. 246 women were enrolled in the postnatal~     period with the primary scientific objective of determining whether food insecurity was an~     independent risk factor for poor maternal nutritional or psychosocial outcomes or for~     sub-optimal infant feeding practices.~   "
49011|NCT02925416|"~     The purpose of this study is to evaluate the safety and tolerability of two 1200-mg IV~     infusions of oritavancin when administered one week apart.~   "
49012|NCT02925403|"~     This is a study in which healthy adult volunteers will be given either an experimental~     Malaria vaccine or a saline control vaccine.~      Each volunteer will receive three vaccinations in total. Volunteers will be randomly~     allocated to one of three groups:~      Group 1 will receive a low dose of the Malaria vaccine on days 0, 28, and 56. Group 2 will~     receive a high dose of the Malaria vaccine on days 0, 28, and 56. Group 3 will receive a~     saline solution on days 0, 28, and 56.~   "
49013|NCT02925390|"~     This study involves research, and the purpose of this study is to evaluate live birth rates~     among couples who are treated by Natural procreative technology, (NPT) for infertility and~     miscarriage.~      Comparisons will be made to those declining NPT treatment, waiting for NPT treatment,~     receiving other treatment, or stopping treatment. The investigator seeks to document specific~     pregnancy rates for different factors such as age and type of infertility diagnosis.~     Investigators will also assess characteristics of environmental exposures that may be~     associated with infertility. Couples will be followed for up to three years, regardless of~     when they begin NPT treatment, or whether they continue treatment. Data from all couples will~     be useful for this study, regardless of their individual circumstances or actual treatment.~   "
49014|NCT02925377|"~     Female handball athletes are at a particular risk of sustaining lower extremity injuries. The~     study examines time-dependent adaptations of static and dynamic balance as potential injury~     risk factors to a specific warm-up program focusing on neuromuscular control.~   "
49024|NCT02925247|"~     Direct oral anticoagulants (DOAC), an inhibitor of factor IIa (dabigatran) or factor Xa~     inhibitors (rivaroxaban, apixaban) are an alternative to treatment with warfarin in patients~     with atrial fibrillation (AF) non-valvular .~      These molecules have demonstrated non-inferiority compared to warfarin standard treatment for~     the prevention of thromboembolic events in patients with non-valvular AF at high risk~     thomboembolique (Score CHA2DS2-VASc ≥1). These molecules have a constant biological~     effectiveness does not require laboratory monitoring in clinical practice, unlike AVK whose~     use requires, because of their variability action intra- and inter-individual, a constant~     dose adjustment based on 'Nationalized Index Ratio (INR).~      The objective of this study is to evaluate the interest of specific dosage of anti-activated~     factor X activity (Xa) in the identification of non-observing treating patients with Factor~     Xa inhibitor in patients with non-FA valvular~   "
49015|NCT02925364|"~     The current study is an amendment to a previously approved blinded randomized controlled~     trial (NCT02697812) which examines the rate at which the sternal retraction maneuver is~     performed during cardiac surgery (standard over 30 seconds versus. gradual over 15 minutes)~     and examines the incidence of chronic post-sternotomy pain 6 months following surgery.~      Patients enrolled in the parent study will be identified at the 6 month follow-up and~     recruited in terms of whether they report chest pain. A total of 30 participants will be~     recruited (15 with and 15 with no pain) to undergo a single MRI session in which functional~     MRI will be done on the brain stem and spinal cord and anatomical MRI images will be~     collected for specific chest and neck structures. This will indicate whether there are~     long-term differences in pain processing and/or physical damage to neck and chest structures~     in those with and without chronic pain 6 months following coronary artery bypass graft~     surgery. All functional and anatomical MRI images will be reviewed and interpreted with study~     personnel blinded to whether the patient is reporting pain or no pain at their 6 month~     follow-up interview.~   "
49016|NCT02925351|"~     This pilot trial studies how well fluorine F 18 clofarabine positron emission tomography~     (PET)/computed tomography (CT) works in imaging patients with autoimmune or inflammatory~     diseases. Fluorine F 18 clofarabine is an imaging agent or tracer which may be taken up by~     inflammatory tissue in the body. Diagnostic imaging, such as PET/CT scans, can be used to~     measure the amount of injected tracer that is taken up by inflammatory tissue. PET/CT scan~     may help to determine how fluorine F 18 clofarabine is distributed throughout the body.~   "
49017|NCT02925338|"~     National, prospective, multicentre observational study designed for eligible patients treated~     with Inflectra.~      Its objectives are to describe under real conditions of use, the profile of patients treated~     with Inflectra and the response to treatment.~   "
49018|NCT02925325|"~     Residual Symptoms of Depression (SRD) are those symptoms that persist despite remission of~     MDD. They are characterized by a high incidence (approx. 90% of patients in remission) at the~     psychiatric clinic, have become a growing problem. Its presence is associated with a high~     probability of relapse / recurrence and disability, as determined by decreased performance~     and low quality of life. Their neglect has generated an increase in clinical and~     socioeconomic costs, alerting the need for research to provide treatment strategies. The~     application of different types of psychotherapy has been successful in abating SRD. The~     present study aims to evaluate the clinical changes related to the application of music~     therapy as a treatment of SRD, through a randomized controlled trial with two treatment arms~     trial. Music Therapy (MT) is a psychotherapy provided by specialized health professionals,~     and is defined as the clinical use of musical evidence-based interventions within a~     therapeutic relationship. MT treatment group will design an application schema of 8 sessions~     (2 hrs. Each) over a period of two months (one session per week). The control group will~     receive the Usual Treatment (TU) which corresponds to the usual clinical psychiatric~     treatment by the physician in the INPRF, with the same duration. The evaluation will be~     conducted with clinimetric testing at baseline, at the end of the track and after three~     months of treatment. This study seeks to identify the presence of SRD in a Mexican sample and~     explore a treatment designed for that purpose, also, show that the MT is a cost-effective~     implementation can become a new clinical option to extend the possibilities of assistance and~     deepen the investigation of this problem.~   "
49019|NCT02925312|"~     The MedStar Diabetes Institute (MDI), in partnership with key MedStar Health system diabetes~     stakeholders, seeks to implement an evidence-based innovative integrated care pathway for~     MedStar patients with uncontrolled diabetes which will demonstrate improvement in diabetes~     care outcomes.~   "
49020|NCT02925299|"~     The main study objective is to determine whether 24/7 automated closed-loop glucose control~     combined with low glucose feature will improve glucose control as measured by HbA1c.~      This is an open-label, multi-centre, multi-national, single-period, randomised, parallel~     group design study, involving a 6 month period of home study during which day and night~     glucose levels will be controlled either by a closed-loop system combined with low glucose~     feature (intervention group) or by insulin pump therapy alone (control group).~      It is expected that a total of up to 150 subjects (aiming for 130 randomised subjects) with~     type 1 diabetes will be recruited through paediatric outpatient diabetes clinics of the~     investigation centres. Participants will all be on subcutaneous insulin pump therapy.~      Subjects in the intervention group will have proven competencies both in the use of the study~     insulin pump and the study continuous glucose monitoring (CGM) device, and will receive~     appropriate training in the safe use of closed-loop insulin delivery system and low glucose~     feature. All subjects will have regular contact with the study team during the home study~     phase including 24/7 telephone support. The primary outcome is between group differences in~     HbA1c levels at 6 months post study arm initiation. Secondary outcomes are the time spent in~     the glucose target (3.9 to 10.0mmol/l; 70 to 180mg/dl), time spent with glucose levels above~     and below target, as recorded by CGM, and other CGM-based metrics. Safety evaluation~     comprises assessment of the frequency of severe hypoglycaemic episodes and diabetic~     ketoacidosis (DKA).~   "
49021|NCT02925286|"~     The purpose of this study is to determine the effects of a workplace prevention program~     targeting problematic gambling.~   "
49022|NCT02925273|"~     The goal of this project is to determine the optimal technique to elicit the grasping~     response in patients with dementia or suspected frontal lobe dysfunction. The proposed study~     is to perform two techniques to elicit grasp response in patients with dementia or suspected~     frontal lobe dysfunction and observe the presence or absence of the response and prominence~     of the response on a proposed rating scale. Future goals will be aimed at aiding clinicians~     in refining their clinical techniques to be more sensitive for diagnosing frontal lobe~     dysfunctions.~   "
49023|NCT02925260|"~     A study to investigate the prevalence of pelvic collections in a representative sample of~     participants with normally functioning ileal pouches. It also aims to establish the~     feasibility and reporting variables for dynamic MRI enemas in ileal pouches and defaecating~     enema pouchography.~   "
49034|NCT02925117|"~     This is an 88-week Phase 2b, randomized, double-blind, parallel-group, placebo-controlled~     multicenter study to evaluate the safety and efficacy of ABT-494 (upadacitinib) in adult~     subjects with moderate to severe atopic dermatitis. In Period 1, subjects will be randomized~     in a 1:1:1:1 ratio to one of four treatment groups.~   "
49025|NCT02925234|"~     This is a prospective, non-randomized clinical trial that aims to describe the efficacy and~     toxicity of commercially available, targeted anticancer drugs* prescribed for treatment of~     patients with advanced cancer with a potentially actionable variant as revealed by a genomic~     or protein expression test. The study also aims to simplify patient access to approved~     targeted therapies that are contributed to the program by collaborating pharmaceutical~     companies and to perform next generation sequencing on tumor biopsies for biomarker analyses.~     Eligible patients have an advanced solid tumor, multiple myeloma or B cell non-Hodgkin~     lymphoma for which standard treatment options are no longer available and acceptable~     performance status and organ function. A genomic or protein expression test must have been~     performed on the tumor and the results must identify at least one potentially actionable~     molecular variant as defined in the protocol. Results from the molecular profiling test will~     be used to determine an appropriate drug(s) from among those available in the protocol. The~     choice of drug will be supported by a list of potential profiles, a molecular tumor board, a~     knowledge library and by study coordinators for review and approval of the match. The~     protocol-specified treatment will be administered to the patient once any drug-specific~     eligibility criteria are confirmed and a fresh pre-treatment biopsy is performed for future~     genetic studies. All patients who receive treatment with a drug available in the protocol~     will be followed for standard efficacy outcomes including tumor response, progression-free~     and overall survival as well as duration of treatment. In addition, treatment related~     toxicity will be evaluated.~   "
49026|NCT02925221|"~     This study is part of the Health Canada approval requirement for tolvaptan and is an~     observational, non-interventional study (NIS) describing the impact of tolvaptan on~     ADPKD-related burden of illness as measured with a set of Patient Reported Outcome (PRO)~     Questionnaires. The study is also describing the time to renal replacement therapy (RRT),~     such as dialysis and transplantation, and the long-term mortality rate and causes (i.e. renal~     and hepatic), in ADPKD patients treated with tolvatan (JINARC™)~   "
49027|NCT02925208|"~     Cortical mastoidectomy and posterior tympanotomy is a classic approach for cochlear implant.~     Intimate knowledge of the relevant surgical anatomy of the temporal bone and facial recess is~     important to safely perform the posterior tympanotomy. Anatomical variation of facial nerve~     such as lateral or anterior position of vertical segment of facial nerve, will render this~     approach challenging. In this research, investigators proposed a Radiological Classification~     system of the position of vertical segment of facial nerve in relation to the lateral~     semicircular canal to predict difficult cases with narrow facial recess.~   "
49028|NCT02925195|"~     The goal of this clinical trial is to determine individual-level genetic and metabolic~     characteristics that modify the response to cholecalciferol treatment.~      This study is double blind, parallel design, randomized clinical trial that will assess~     genetic and metabolic characteristics that modify the response to cholecalciferol treatment.~     . Eligible participants will be randomly assigned to receive cholecalciferol treatment (2,000~     international units of cholecalciferol daily by mouth) or placebo in a 3:1 ratio for a total~     duration of 16-weeks. The planned sample size is 1,600. The primary aim of this study is to~     identify genetic polymorphisms, clinical characteristics, and biomarkers that modify the~     biologic response to vitamin D3 treatment, assessed by changes in serum concentrations of~     parathyroid hormone (PTH) and 1,25(OH)2D and urine calcium excretion.~   "
49029|NCT02925182|"~     The aim this study was to investigate the efficacy of Er,Cr:YSGG laser irradiation in~     reducing pain and on healing rate of recurrent aphthous stomatitis 40 patients with RAS were~     included to the study. For each patient, ulceration were randomly assigned to the test or the~     control group. In test group RAS irradiated with Er,Cr:YSGG laser using non-contact mode. In~     the placebo group, the same Er,Cr:YSGG laser without laser emission was used. Pain was~     evaluated with visual analog scale (VAS). Healing of RAS (HRAS) was graded by a clinician.~   "
49030|NCT02925169|"~     Cricoid is considered the narrowest part with the shape of airway defined as elliptical with~     the subglottis as the narrowest region.~      This study using imaging modality (2D CT images) is done to determine any differences in~     airway shape between infants and children, and to evaluate the dimensional transition between~     the subglottic area and the cricoid ring.~   "
49031|NCT02925156|"~     This project examines whether individuals' amount of activity energy expenditure (AEE) is~     related to adiposity and adiposity/diabetes-related hormones in a diverse sample of 2500, and~     to test the ecological hypothesis that a decline in levels of AEE is an important cause of~     the increases in obesity that are currently taking place in many societies.~      One goal is to use doubly labeled water and/or accelerometers to objectively measure activity~     energy expenditure in community samples from five adult populations across the spectrum of~     obesity risk. From each site, (i.e., Ghana, South Africa, Seychelles, Jamaica, and the US),~     500 black adults will be recruited. Among all participants, AEE will be measured using~     accelerometers and in a subset of 75 per site, AEE will also be measured by doubly labeled~     water.~      The doubly labeled water sample will be used to confirm site-specific concordance with the~     accelerometer measurements and to estimate population mean levels of AEE. Additionally, body~     composition, dietary intake, fasting glucose, insulin, adiponectin, leptin and ghrelin will~     be measured. The relationships between calories expended in activity and body composition,~     dietary intake, glucose, hormones and adipocytokines, both within and between each population~     using doubly labeled water and accelerometers will be examined. In this longitudinal study,~     weight will be measured at 12 and 24-months, and AEE by accelerometer will be assessed at~     enrollment and again at 2-years of follow-up; associations between change in AEE and change~     in weight will be estimated.~      The central purpose of this project is to test whether AEE or change in AEE can be identified~     as a contributory mechanism to population-wide weight gain and, if so, to quantify its~     importance. In addition, we seek to understand the interrelationships between the~     adipocytokines and the hormones ghrelin and insulin as well as AEE in the regulation of body~     weight across the continuum of body mass indices (BMI) represented by these five populations.~   "
49032|NCT02925143|"~     To assess the impact of an e-learning course in neuromuscular monitoring on the frequency of~     application of objective neuromuscular monitoring for assessment of depth of neuromuscular~     blockade in general anaesthesia and secondarily on the incidence of residual neuromuscular~     blockade after anesthesia.~      We will collect data prospectively from 6 Danish anaesthesia departments from the time of~     intervention, using data from the Anaesthesia Information Management System (AIMS). Baseline~     data is obtained from another study based on the same data extraction procedure~     (NCT02914119).~   "
49033|NCT02925130|"~     Beta2-mimetics such as Salbutamol have been shown to have ergogenic effects. Acute and~     chronic inhaled or oral doses of Salbutamol have been shown to increase whole body exercise~     and muscle performances. The underlying mechanisms are however unclear. Some data suggest~     that Salbutamol may have some effects on the central nervous system which may explain the~     improved exercise and neuromuscular performances. The present study aims to assess the~     effects of acite inhaled or oral Salbutamol intake on the neuromuscular system by using~     neurostimulation techniques and magnetic resonance imaging.~   "
49036|NCT02925091|"~     Helicobacter pylori infects ~ 50% of the world's population and a quarter of the European~     population. H. pylori is responsible for a large proportion of gastric and duodenal ulcers~     and gastritis. Chronic infection with H. pylori is a risk factor for the development of~     stomach cancer and MALT (mucosa-associated lymphoid tissue) Lymphoma. The prospects of~     success for an antimicrobial eradication therapy is drastically reduced by the significant~     increase in antibiotic resistance in Austrian H. pylori isolates. The currently available~     data were obtained however from narrowly defined geographical regions and the clinical~     routine without information on patient selection. We suspect a considerable geographical~     variability of resistance patterns and a clinical bias for a preferential investigation of~     patients with unsuccessful, empirical eradication therapy. The objective of the proposed~     study is therefore an Austria-wide collection of data on H. pylori resistance in a~     prospective clinical study. The data thus collected will enable a significant improvement in~     current treatment recommendations.~   "
49037|NCT02925078|"~     The primary objective of this study is to compare the amount of implant marginal bone loss~     radiographically and probing depth in between thin and thick mucosa group that will receive a~     machined collar implant.~      Null hypothesis is mucosa thickness does not affect implant marginal bone loss on implant~     with smooth collar.~   "
49038|NCT02925065|"~     This controlled prospective cohort study is designed to assess the feasibility and effect of~     twice-weekly 60 minute non-traditional guitar classes on PD patient's self-reported and~     measurable outcomes including upper extremity function, motor findings, quality of life,~     mood, and cognitive findings. 24-30 individuals with PD will be randomly assigned to an~     early-start and a late-start guitar instruction group. Prior to conducting a larger study,~     this study seeks to assess the possibility that participation in an instrumental performance~     activity in a group setting may improve outcomes in PD patients.~   "
49039|NCT02925052|"~     A randomized controlled prospective study of orogastric tube placement with the Gastric Tube~     Guide vs conventional placement.~   "
49040|NCT02925039|"~     The sit-to-stand (STS) movement is a key functional movement critical to independent living.~     This movement is physically demanding to conduct, especially in older adults, and in the~     presence of physical impairments associated with a range of conditions, such as stroke,~     osteoarthritis, Parkinson disease and hip arthroplasty. A limited capacity to perform this~     movement increases the risk of falls, dependency and increased support for personal care and~     rehabilitation. Restoring independence in this movement is, therefore, considered a priority~     for physical rehabilitation.~      Sit-to-stand capacity can be regained through participating in rehabilitation exercises.~     Providing feedback on performance of this movement could enhance the training. Thus, it is an~     essential aspect of physical therapy. Healthcare providers are required to meet the needs of~     an increasingly frail population as well as meeting national, evidence-based, guidelines for~     improving outcomes in conditions such as stroke which includes an increase in the practice~     repetition of functional movements. Reliance on rehabilitation staff to provide practice,~     however, places a limit on practice volume, potentially restricting outcomes. Using~     technology to enhance safe, repetitive practice of this movement with minimal supervision~     from skilled professionals would be beneficial to patients and rehabilitation services.~      The primary aim of this study is to test the acceptability and feasibility of a STS training~     system that enhances movement feedback to patients undergoing rehabilitation. A secondary aim~     is to gather data on the effectiveness of the system compared to conventional rehabilitation.~     This information will inform a statistically powered phase 2 trial.~   "
49041|NCT02925026|"~     Randomized, double-blind, placebo controlled trial of daily lactoferrin and lysozyme~     supplementation in improving environmental enteric dysfunction in Malawian children~   "
49042|NCT02925013|"~     This study aims to investigate the omega 3 lipid profile in pregnant women at term and their~     fetuses compared to non pregnant women , in normal western diet adding no supplementation~   "
49043|NCT02925000|"~     This is a phase I/IIa, Open label, Dose-escalation Study Investigating the Safety,~     Tolerability, and Pharmacokinetics of Intravenous Liposomal Vinorelbine Tartrate Injection in~     Patients with Advanced Malignancy.~   "
49044|NCT02924987|"~     Multicenter randomized trials have demonstrated the safety and efficacy of intravitreal~     anti-vascular endothelial growth factor (anti-VEGF) agents for the treatment of diabetic~     macular edema. The results are generally good in the short term, with approximately 75% of~     patients maintaining or improving vision after initiation of treatment. Despite this~     favorable outcome, the observation of persistent fluid is not infrequent during treatment,~     even in patients undergoing monthly treatment sessions. Persistent fluid was observed on~     optical coherence tomography (OCT) in 70.9% of patients receiving bevacizumab monthly and in~     79% of those receiving bevacizumab as needed at the end of the first year in the Comparison~     of diabetic macular edema. Treatment Trials. It is possible that resolution of this fluid,~     especially when it is centrally located (i.e., foveal), might result in better visual~     outcomes.~      A drug with higher VEGF-binding affinity may help patients with persistent fluid despite~     treatment with bevacizumab. Aflibercept is a new intravitreal VEGF antagonist approved on 28~     November 2014 by the Health Canada for the treatment of diabetic macular edema.~      In contrast to the antibody-based VEGF binding strategy used by bevacizumab, aflibercept~     incorporates the second binding domain of the VEGFR-1 receptor and the third domain of the~     VEGFR-2 receptor. By fusing these extracellular protein sequences to the Fc segment of a~     human IgG backbone, developers have created a chimeric protein with a very high VEGF binding~     affinity. Aflibercept binds all isomers of the VEGF-A family like bevacizumab, but it also~     binds VEGF-B and placental growth factors 1 and 2,1,2 which have been both implicated in the~     pathogenesis of diabetic retinopathy and of age-related macular degeneration. In addition,~     because of the increased trough binding activity and the stronger binding affinity,~     aflibercept should be efficacious in neutralizing VEGF more effectively and for longer~     duration.~   "
49045|NCT02924974|"~     This study will investigate if a single shot of spinal morphine will increase patient~     satisfaction when compared to intravenous morphine in Robot-Assisted Radical Prostatectomy~   "
49046|NCT02924961|"~     The goal of this study is to compare the fixed bearing (FB) Triathlon knee (Stryker, USA) and~     the mobile bearing (MB) Triathlon knee (Stryker, USA) and study the effect of implant design~     on kinematics and micromotion. During two tasks the kinematics measured with fluoroscopy~     (kinematics and movement of the polyethylene bearing). Roentgen Stereophotogrammetric~     Analysis (RSA) will be used to evaluate micromotion between prosthesis and the bone for the~     MB and FB Triathlon knee.~   "
49047|NCT02924948|"~     Endoscopic ultrasonography (EUS) is an essential technique required in diagnosis of~     pancreatobiliary diseases. In previous studies, 6% of patients who undergone EUS had~     significant throat pain. (NRS scale 5 or greater) Although some endoscopists think balloon~     inflation while EUS insertion could result in decreased throat damage and pain, there is no~     data to back up. We designed a single center randomized pilot study to compare throat pain~     caused by EUS insertion with conventional vs balloon inflation method.~   "
49049|NCT02924922|"~     Currently, partial nephrectomy (PN) is considered as the gold standard treatment modality for~     small renal masses. In this setting, robot-assisted and conventional laparoscopic approaches~     are gaining more consensus every day. However, until now, no superiority of one technique~     over the other has yet been demonstrated, especially on postoperative function recovery.~      This study compares oncological and functional outcomes after laparoscopic partial~     nephrectomy versus robot assisted partial nephrectomy.~   "
49050|NCT02924909|"~     Phase II trial of induction chemotherapy with carboplatin AUC 6 plus paclitaxel 175 mg/m2 in~     a 21 day cycle for two cycles followed by radiotherapy 4500 cGy in 25 fractions plus~     carboplatin AUC=2 paclitaxel 50 mg/m2 in a week regimen followed by minimally invasive~     surgery after 6 to 10 weeks. A PET scan will be performed at the time of randomization and 14~     days after de first cycle to determine the relation between metabolic response and survival.~   "
49051|NCT02924896|"~     Aims: To investigate whether acute ingestions of palm oil will have an effect on appetite~     regulation~      Design: A randomized, single blind, cross over design including 4 single study visits~     separated by a week. Visit 1 is an acclimatization visit followed by visit 2,3, and 4 where~     different types of fat will be given.~      Population: 12 healthy males and females aged between 18 and 60 years with body mass index~     (BMI) between 18.5- 29.9kg/m2 and normal fasting plasma glucose and no evidence of insulin~     resistance will be recruited. No-pre existing morbidity including cardiac, hepatic or renal~     disease, history of diabetes, hypertension or hyperlipidaemia.~      Treatment: Acclimatization visit: At visit 1, all participants will be given a milkshake like~     drink containing fat, protein and carbohydrate. A cannula will be inserted for the duration~     of the study day but no blood will be taken. Studies show than during the first visit stress~     response can affect the metabolic response to the study drink resulting in inaccurate~     results.~      Study visit 2,3,4: following the acclimatization visit, participants will attend 3 more study~     visits separated by a week to test the metabolic response to the following fats: palm olein,~     interesterified palm olein and soybean oil in random order. Participants will be asked to~     complete a visual analogue scale questionnaire about their appetite at each time point.~     Fasting and postprandial plasma glucose, insulin, appetite hormones and lipids will be~     measured.~   "
49052|NCT02924883|"~     This Phase II, double-blind, randomized, placebo-controlled multicenter study will~     investigate the efficacy and safety of trastuzumab emtansine in combination with atezolizumab~     or atezolizumab-placebo in participants with HER2-positive locally advanced or metastatic BC~     who have received prior trastuzumab and taxane based therapy, either alone or in combination,~     and/or who have progressed within 6 months after completing adjuvant therapy.~   "
49053|NCT02924870|"~     Main objective: To compare the level of physical activity (PAL) at 12 months in patients with~     moderate to very severe chronic obstructive pulmonary disease (COPD) between those who~     completed a health education program and those who did not.~      Study patients. Subjects older than 35 years; diagnosis of moderate to very severe COPD (FEV1~     <80% predicted), established at least 3 months; current or former smoker with an accumulated~     consumption >10 packs x year; and hospital admission for COPD exacerbation.~      Design. Randomized, parallel and open-label clinical trial, controlled with conventional~     treatment.~      Intervention: During hospitalization, selected patients will receive conventional treatment.~     At discharge, they will be randomized (1:1) to control group [treatment and follow-up~     according to conventional clinical practice] or intervention group [in addition to~     conventional treatment and follow-up, the patients will be referred to a nursing consultation~     for perform two health education sessions, at 15 and 30 days after hospital discharge].~      Measurements. At 15 days and 12 months after discharge, the following determinations will be~     made: anthropometric characteristics; clinical evaluation (smoking history, date of COPD~     diagnosis, comorbidities, current medication; health care utilization; moderate or severe~     COPD exacerbations); questionnaires (mMRC, Charlson, COPD-specific co-morbidity test (COTE),~     COPD Assessment Test (CAT) and LCADL), spirometry and six-minutes walking test; and~     evaluation of daily physical activity using an accelerometer.~   "
49054|NCT02924857|"~     The Chocolate Touch study is a randomized, multi-center, prospective, adaptive study,~     designed to show sufficient safety and effectiveness of the Chocolate Touch™ for use in~     superficial femoral or popliteal arteries with the intention of obtaining regulatory approval~     to market this device in the United States~   "
49055|NCT02924844|"~     The aim of this before-after study was to assess the impact of a clinical pharmacy bundle of~     care activities on patient outcomes (length of hospital stay as a primary endpoint) and cost~     expenditure in two French ICUs.~   "
49056|NCT02924831|"~     1. To study the relationship between Chronic Fatigue Syndrome (CFS) and heart rate (HR) and~          its variability (HRV).~        2. To compare the curative effects and the HR/HRV indices between applicationa of different~          acupoints as well as different treatments (acupuncture and moxibustion).~   "
49057|NCT02924818|"~     Chronic inflammatory pulmonary diseases including chronic obstructive pulmonary disease~     (COPD), interstitial lung diseases (ILD), bronchiectasis, and cystic fibrosis (CF) are~     characterized by lung inflammation and remodelling. Clinical, functional, microbiological,~     biological, pathological and prognosis features are highly variable and heterogeneous. A~     precise phenotyping is a key-element to better understanding the pathophysiology of these~     chronic inflammatory diseases and to develop innovative treatment strategies.~      The objectives of this prospective study is to analyze the clinical, demographic, biological,~     morphological, pathological, and microbiological characteristics in a cohort of patients~     diagnosed with COPD, ILD, bronchiectasis, and CF. The associations between clinical,~     demographic, biological, morphological, pathological, and microbiological features will be~     assessed.~      The Cohort for Research and Innovation in Chronic Inflammatory Respiratory Diseases (the~     RINNOPARI Project: Recherche et Innovation en Pathologie Respiratoire Inflammatoire) is a~     monocentric study conducted at the University Hospital of Reims, France. Adult patients (>18~     year-old) followed at the University Hospital of Reims and diagnosed with COPD, ILD,~     bronchiectasis, or CF will be considered for inclusion. Patients will sign an informed~     consent for inclusion. Exclusion criteria include subjects protected by the law as required~     by the French authorities. Control patients with no respiratory diseases after clinical and~     pulmonary function tests assessment will be also included. The expected number of patients~     included is 225 (COPD, n=100; CF, n=25; bronchiectasis, n=25; ILD, n=25; controls, n=50).~     Inclusion will be conducted for 36 months from September 2016 (9/30/2016) to September 2019~     (9/30/2019).~      For all COPD, ILD, bronchiectasis, and CF patients included, data will be registered at~     inclusion, and at follow-up visits for 10 years. Patients will be followed-up as usual care~     with no specific therapeutic intervention. For control patients, data will be registered at~     inclusion with no follow-up.~      Data will be registered in a centralized anonymized database. The characteristics of the~     patients will be described as mean and standard deviation for quantitative data and as number~     and percentages for qualitative data. Comparisons and associations between groups and~     variables will be analyzed by Student, Wilcoxon, Chi2, Fischer exact, and Spearman tests as~     applicable. A p<0.05 will be considered as significant.~      This study should help to better characterize clinical, demographic, biological,~     morphological, pathological, and microbiological characteristics and phenotypes in chronic~     inflammatory respiratory diseases.~   "
49058|NCT02924805|"~     Comparison of telemedical prehospital emergency care and conventional on-scene physician~     based care of hypertensive emergencies and urgencies. The adherence to current Guidelines~     should be researched.~   "
49060|NCT02924779|"~     This is a small observational study investigating the physical changes that occur to epidural~     catheters after insertion for obstetric anaesthesia. Using the observed physical changes as a~     correlate for the position of the catheter in the patient we will investigate a connection~     between the position and e function during labour. This information may be useful in guiding~     the physicians responses to epidurals that do not provide adequate analgesia to aid in~     deciding on the most appropriate action~   "
49061|NCT02924766|"~     The purpose of this study is to assess the safety and pharmacokinetics of niraparib when~     administered in combination with an androgen receptor (AR)-targeted therapy (apalutamide or~     abiraterone acetate plus prednisone) in adult men with metastatic castration resistant~     prostate cancer (mCRPC) who may or may not have deoxyribonucleic acid (DNA)-repair anomalies.~   "
49062|NCT02924753|"~     This is a study for patients who have been previously treated for B-ALL. The purpose of this~     study is to determine the safety and feasibility of CART-19 cells to the patients with~     relapsed and refractory CD19+ B-ALL.~   "
49063|NCT02924740|"~     Pelvic Floor Muscle Training (PFMT) is the basis of conservative treatment in women with SUI.~     In systematic reviews, PFMT was recommended as a first option for treatment of SUI. The aim~     of PFMT is to improve sphincter activity and increase the support of bladder and urethra.~     Recommendations regarding the prevention and treatment of SUI with PFMT include Knack~     maneuver (the conscious contraction of the pelvic floor before and during the abdominal~     pressure increases); pelvic floor exercises to enhance the structural support and endurance~     of pelvic floor muscles; adding transversus abdominis contraction; and functional~     rehabilitation.It was reported that the progressive overload principle should be considered~     to improve the muscle strength and endurance. According to this principal, resistance against~     to movement, duration and/or frequency should be increased to obtain the optimal response.~     There are a lot of methods to run a muscle or muscle group based on the progressive overload~     principal. These are adding resistance or weight, increasing the duration and number of~     contraction, changing the type of exercise and the range of movement. In the literature, it~     was reported that special vaginal or rectal tools, vaginal cones or tampons might be used to~     establish resistance during the pelvic floor muscle exercises.the use of cones in a different~     way may provide extra benefit for patients: patients can be instructed to perform pelvic~     floor muscle contraction and try to pull the cone or the other tools out of the vagina. In~     this study, investigators preferred to use vaginal tampons since pulling the cone out of the~     vagina cause the elimination of the weight of the cone. Vaginal tampons are also sterile,~     hygienic, and single use. There is no study investigates the effects of vaginal tampon~     exercises in the literature. Therefore, the aim of this study is to investigate the effect of~     the vaginal tampon training adding to PFMT on symptoms of the urinary incontinence, the~     strength and the endurance of pelvic floor muscles and the quality of life.~   "
49064|NCT02924727|"~     The purpose of this study is to evaluate the efficacy and safety of LCZ696 titrated to a~     target dose of 200 mg twice daily, compared to ramipril titrated to a target dose of 5 mg~     twice daily, in addition to conventional post-AMI treatment, in reducing the occurrence of~     composite endpoint of CV death, HF hospitalization and outpatient HF (time-to-first event~     analysis) in post-AMI patients with evidence of LV systolic dysfunction and/or pulmonary~     congestion, with no known prior history of chronic HF..~   "
49065|NCT02924714|"~     The trial The stop-GIST trial is an Oslo University Hospital sponsored, prospective,~     open-label, 1-group, multicenter phase II trial evaluating discontinuation of imatinib in~     highly selected patients treated with imatinib longer than 5 years for oligo-metastatic GIST~     (≤ 3 metastases) and who have no detectable overt GIST lesions on CT/MRI imaging following~     complete surgical resection (R0/R1-resection) or radiofrequency ablation (RFA) of the~     metastases.~   "
49066|NCT02924701|"~     Primary biliary cholangitis (PBC) is an autoimmune chronic liver disease, characterised by~     destruction of the small intrahepatic bile ducts. sCD163 is a macrophage activation marker~     shedded into plasma by macrophages in the liver. sMR is a soluble mannose receptor. The~     investigators want to investigate whether sCD163 and sMR correlate with disease severity in~     patients with PBC, and whether sCD163 and sMR can predict short term disease progression,~     changes in quality of life and death in these patients.~   "
49067|NCT02924688|"~     A once-daily 'closed' triple FDC therapy of FF/UMEC/VI via a single ELLIPTA® dry powder~     inhaler (DPI) is being developed by GlaxoSmithKline (GSK) with the aim of providing a new~     treatment option for the management of asthma by improving lung function, health-related~     quality of life (HRQoL) and symptom control over established combination therapies. This is a~     phase III, multi-center, active-controlled, double-blind, parallel-group study to compare the~     efficacy, safety and tolerability of the FDC of FF/UMEC/VI with the FDC of FF/VI. This study~     has 5 phases: Pre-Screening (Visit 0), Screening/Run-in, Enrolment/Stabilization,~     Randomization/Treatment, and Follow up. At Visit 1 (Screening), subjects meeting all protocol~     defined inclusion/exclusion criteria will enter a 3-week run-in period and will receive fixed~     dose inhaled corticosteroid/long-acting beta agonist (ICS/LABA) (fluticasone/salmeterol,~     250/50 micrograms (mcg), via the DISKUS® DPI) one inhalation twice a day. At Visit 2~     (Enrolment), eligible subjects will be enrolled into the 2-week stabilization period to~     receive FF/VI (100/25 mcg via the ELLIPTA DPI once a day, in the morning). At the conclusion~     of the stabilization period (Visit 3), all subjects who meet the pre-defined randomization~     criteria will be randomized 1:1:1:1:1:1 during the treatment period to receive either~     FF/UMEC/VI (100/62.5/25 mcg; 200/62.5/25 mcg; 100/31.25/25 mcg; 200/31.25/25 mcg) or FF/VI~     (100/25 mcg; 200/25 mcg) via the ELLIPTA DPI once daily in the morning. The duration of the~     treatment period is variable but will be a minimum of 24 weeks and a maximum of 52 weeks.~     Subjects will have up to 6 on-treatment clinic visits scheduled at Visits 3, 4, 5, 6, 7 and~     8/End of Study (EOS) (Weeks 0, 4, 12, 24, 36 and 52, respectively). A follow-up visit will be~     conducted approximately 7 days after the end of treatment period or, if applicable, after the~     early withdrawal visit. Subjects will be provided with short acting albuterol/salbutamol to~     be used on an as-needed basis (rescue medication) throughout the study. Approximately 2250~     subjects will be randomized, with approximately 375 subjects randomized to each of the 6~     double-blind treatment arms to ensure approximately 337 evaluable subjects per treatment arm.~     DISKUS and ELLIPTA are registered trademarks of GSK groups of companies.~   "
49068|NCT02924675|"~     Referred otalgia is one of the symptoms of oropharynx and hypopharynx cancer. It can be~     primary (otodynia) or secondary (referred otalgia and projected pain). The mechanism of~     referred otalgia involves several non adjacent nerve territories as those of head, neck or~     ear. Referred otalgia is a projected pain due to injury (most of the time cancer) localized~     far from the ear but sharing the same innervation. In this contest, the otoscopy is normal.~      Four cranial nerves participate in the sensory innervation of the external ear: the~     trigeminal nerve (V) via the auriculo temporal nerve (V3), the facial nerve (VII) for the~     Ramsay-Hunt's zone with the conch, tragus, antitragus, a part of the anthelix, of the~     external auditory meatus and of the eardrum, the glossopharyngeal nerve (IX) via the~     Jacobson's nerve for the external ear canal and the C2 and C3 cervical plexus. However, there~     are important interindividual anatomical variations.~      The relationship between referred otalgia and probable nerve damage has been described. In he~     oropharynx and hypopharynx, the proximity of the sensory innervation of the ear can then~     explain the otalgia during the cancer progression. Then referred otalgia has a neuropathic~     component.~      In the literature, the curative treatment of referred otalgia is the cancer treatment.~     However, the high intensity of referred otalgia leads the patients to a large consumption of~     analgesics in particular of opioids. These latter are particularly adapted for pain resulting~     from excess of nociceptive stimulation. Pregabalin (Lyrica®) is an analogue of gamma~     aminobutyric acid. This molecule binds to alpha subunit 2 delta 1 calcium dependent voltage~     channels in the central nervous system. its effectiveness has been demonstrated for the~     treatment of neuropathic pain on diabetic neuropathy, post herpetic neuralgia, lesions in the~     bone marrow but also the postoperative pain when the molecule is administered after the~     surgery. The anti hyperalgesic activity of pregabalin is at a dosage of 150mg/day in two or~     three daily doses.~      The purpose of this study was to evaluate the activity of pregabalin administered orally for~     three weeks after the anesthesia consultation on the intensity of the pain of referred~     otalgia and on its neuropathic component.~   "
49476|NCT02919319|"~     The main objectives of this first-into-man study were to investigate the safety, tolerability~     and the pharmacokinetic profile of single oral doses of ACT-541468 in healthy male adults.~     Pharmacodynamic effects (through a battery of Central Nervous System tests) were also~     assessed.~   "
49069|NCT02924662|"~     Studies have reported that the patient's psychological state such as anxiety, depression and~     other emotion affect the therapeutic effect of osteoarthritis, also may be the important~     reason for the poor knee joint osteoarthritis efficacy.~      The aim of this study are firstly to investigate the depression status of patients with~     osteoarthritis. Secondly, the study will aim to assess whether osteoarthritis progression~     will affect depression status, ultimately, provide reference for clinical.~   "
49070|NCT02924649|"~     Increasing focus on the negative effects of bed rest have become more apparent in the~     intensive care unit within the last decade. A few studies have found an association between~     early rehabilitation starting at the intensive care unit and outcome after discharge from~     rehabilitation. The early mobilization presents with challenges regarding haemodynamic~     stability. The aim of this trial is to assess the feasibility before conducting a larger~     randomised trial that will investigate benefits and harms of an intensive physical~     rehabilitation intervention focusing on mobilisation to the upright position, starting as~     early as clinically feasible in the intensive care unit~   "
49071|NCT02924636|"~     The purpose of this study is to assess the efficacy of an electronic-based intervention to~     help pregnant overweight and obese women gain an appropriate amount of weight and improve~     their delivery i.e. to reduce the rate of labour procedures and interventions. We chose a~     composite outcome including instrumental delivery and Caesarean section, as clinically~     relevant outcomes because the mode of delivery is one of the major goals of the obstetrical~     management and is is strongly associated with body mass index and gestational weight gain.~   "
49072|NCT02924623|"~     Patients and physicians often differ in their perceptions of rheumatoid arthritis (RA)~     disease activity, as quantified by the patient's global assessment (PGA) and by the~     evaluator's global assessment (EGA).~      The objectives of this study were:~        1. to explore the extent and reasons for the discordance between patients and physicians in~          their perception of RA disease activity~        2. to determine if this discordance at baseline is associated with RA outcomes at 1 year~          (remission, function and structure) in early arthritis (EA) in daily clinical practice.~             -  Patients: from the French cohort of early arthritis (EA) ESPOIR³ (at least 2~               swollen joints for less than 6 months, DMARD naïve), fulfilling the ACR-EULAR~               criteria for RA at baseline~      Analysis: At baseline, agreement between PGA and EGA (Bland-Altman plot) was assessed.~     Multivariate linear regression was used to determine the patient and EA features~     independently associated with discordance (calculated as PGA - EGA). Logistic regression was~     used to analyze discordance as│PGA - EGA│≥20.~      Multivariate logistic models were used to determine if discordance at baseline is associated~     with remissions (Boolean, SDAI and DAS28), functional stability (HAQ≤0.5 and deltaHAQ≤0.25)~     and absence of radiographic progression (delta Sharp score<1) after 1 year of follow-up.~   "
49073|NCT02924597|"~     To evaluate the feasibility and efﬁciency of zero ischemia robot-assisted laparoscopic radio~     frequency ablation assisted enucleation of T1a renal cell carcinoma in comparison with~     robot-assisted laparoscopic partial nephrectomy without hilar clamping.~   "
49074|NCT02924584|"~     Breast cancer is the most common cancer in Taiwanese women. Most of them were diagnosed in~     relatively early stages. Only 700 metastatic breast cancer were registered in Official Cancer~     Registration 2012, while more than11,305 were registered as early breast cancer. With broadly~     application of aromatase inhibitors, hormonal-receptor-positive breast cancer patients can~     survive longer and longer. However, there is no prevalence of metastatic breast cancer can be~     available yet. NHIA database coverage is more than 90% population in Taiwan, thus it can be~     an appropriate surrogate of prevalence. In this retrospective database analysis, we will~     explore the real world experience on aromatase inhibitor use for breast cancer in Taiwan.~   "
49075|NCT02924571|"~     The aim of this investigation is to compare the use of bone marrow aspirate concentrate~     (BMAC) and allograft versus to recombinant human bone morphogenetic protein-2 (BMP) in~     subjects undergoing elective thoracolumbar spinal fusion with interbody support. The~     investigators will look at the safety and efficacy of these two different surgical methods by~     assessing surgery outcomes and participants' quality of life.~   "
49076|NCT02924558|"~     The goal of this study is to evaluate the effects of replacing some refined starches and~     added sugars with a combination of egg protein and unsaturated fatty acids on markers of~     cardiometabolic health in men and women with hypertriglyceridemia.~   "
49077|NCT02924545|"~     Evaluate the support of osteoporosis in women over 50 years with severe osteoporotic~     fractures (hip, vertebral, rib, Humeral, pelvic fractures) in the Nîmes University Hospital~     taking prediction of treatment of osteoporosis as criterion.~   "
49078|NCT02924532|"~     The main objective of this study is to establish an optimal threshold Early parathormon (PTH)~     assay in order to exclude hypoparathyroidism , that is to say to obtain a negative predictive~     value of hypoparathyroidism highest possible.~   "
49079|NCT02924519|"~     Shoulder disorders are frequent, often associated with pain and occur in 7-34% of the general~     population and in 21% of the elderly population.~      Of particular interest is prediction of postoperative pain after outpatient arthroscopic~     shoulder surgery since the clinical experience is that surgery does not always provides pain~     relief and the interindividual variation in acute postoperative pain intensity is~     significant. In addition, a Swedish study has shown that shoulder operations are associated~     with longer convalescence than other orthopaedic outpatient surgeries.~   "
49080|NCT02924506|"~     Nowadays, there is no clinical and radiological study comparing two different types of mobile~     implants in patients requiring surgical treatment for symptomatic cervical disc disease.~     Thus, the choice of the ideal implant remains uncertain.~      The goal of this work is to compare the impact of two types of mobile implants in height~     drives, solicitation facets, positioning and collection of prostheses within the~     intervertebral spaces.~   "
49094|NCT02924324|"~     The purpose of this study is to identify whether or not the addition of a numbing medicine~     that is injected directly into the site of the bone marrow procedure can reduce pain and the~     use of opioid pain medication after bone marrow procedures. The addition of this medicine,~     called ropivacaine, is the experimental part of this study. This is the first time~     ropivacaine will be directly injected into the bone marrow site at MSKCC Pediatrics.~   "
49081|NCT02924493|"~     Many patients with endometriosis experience extra genital and abdominal symptoms as a major~     part of their problem. This includes gastrointestinal dysfunction with pain, urinary symptoms~     compatible with interstitial cystitis and gastrointestinal symptoms resembling the irritable~     bowel syndrome (IBS). Such problems may be secondary to changes in autonomous neuronal~     structure and function elicited by the endometriotic elements, which may cause a visceral~     syndrome with the above mentioned symptoms.~      The investigators hypothesize that dietary treatment will improve the experience of~     gastrointestinal symptoms, pain and quality of life in patients with endometriosis-related~     irritable bowel syndrome. The aim of this first randomized, placebo controlled pilot study~     investigating patients with both endometriosis and IBS, is to test the application of a low~     FODMAP diet and a placebo diet for endometriosis-related IBS-like symptoms in order to~     stablish a platform for a randomized controlled study. Thus, the primary aim of this pilot~     study is to investigate the applicability of a placebo diet in patients with endometriosis~     and to investigate the compliance in both intervention group and control group. In addition,~     the aim is to investigate whether the participants find the diet manageable and whether they~     are able to identify the placebo diet.~   "
49082|NCT02924480|"~     Patients scheduled for a cystectomy at Charleston Area Medical Center (CAMC) will be enrolled~     into a randomized, double blinded clinical trial to assess if postoperative pain and ileus~     are reduced by perioperative intravenous lidocaine infusion versus placebo. The hypothesis is~     that patients receiving the lidocaine infusion will experience better pain control and ileus~     resolution. It is believed that lidocaine patients will also have less opioid requirement,~     less mortality, a shorter length of stay, less nausea /vomiting, and fewer adverse events.~   "
49083|NCT02924467|"~     Despite U.S. guidelines for influenza vaccination of all children starting at age 6 months,~     only about half of children are vaccinated annually, leading to substantial influenza disease~     in children and spread of disease to adults. A major barrier is that families are not~     reminded about the need for their children to receive influenza vaccination. The~     investigators will evaluate the impact of patient reminder/recall performed by state~     immunization information systems to improve influenza vaccination rates by using three~     clinical trials in two states. The investigators will assess effectiveness and~     cost-effectiveness of phone reminder/recall on improving influenza vaccination rates. The~     investigators will disseminate the state immunization information system-based~     reminder/recall system to all states for use for seasonal and pandemic influenza vaccinations~     with the goal of lowering influenza morbidity.~   "
49084|NCT02924454|"~     The aim of this study is to investigate whether intravenous lipid emulsion is effective in~     attenuating the clinical effects of a cardioactive drug, exemplified by the beta-blocking~     agent metoprolol. In addition, the investigators will clarify how intravenous lipid emulsion~     affects the pharmacokinetic parameters of metoprolol.~   "
49085|NCT02924441|"~     To determine in a randomized trial whether it is possible to decrease the discomfort and~     anxiety of mammography by using the local analgesic lidocaine, or by using calming music in~     patients receiving a mammogram.~   "
49086|NCT02924428|"~     The purpose of the study is to evaluate the efficacy of facial acne vulgaris treatment using~     the Venus Versa Diamondpolar applicator in combination with the Venus Versa AC dual~     applicator using two intense pulsed light wavelength bands.~   "
49087|NCT02924415|"~     Bipolar disorder patients frequently presents recurring episodes and often experience~     subsyndromal symptoms, cognitive impairment and difficulties in the functioning with a low~     quality of life, relapses of disease and recurring hospitalization. Early diagnosis and~     appropriate intervention may play a role in preventing the neuroprogressive course of bipolar~     illness. The new technologies represent an opportunity to develop psychological standardized~     treatments using internet devices that minimizing the limitations of face to face treatments~     because of its accessibility that allow adjusting to the availability of each user. However,~     although exist many online psychological programs through web and mobile devices for bipolar~     disorder, there is not evidence about their efficacy and effectiveness due to the variability~     in measures and methodology used.~   "
49088|NCT02924402|"~     The purpose of this study is to determine the safety and tolerability of weekly intravenous~     (IV) administration of XmAb13676 and to determine the maximally tolerated dose (MTD) after~     the first dose, and then to determine the MTD after second and subsequent infusions.~   "
49089|NCT02924389|"~     The purpose of this study is to find out how well the HIV medication dolutegravir gets into~     different parts of the body: including blood plasma, special blood cells, and rectal tissue.~     Specifically, investigators want to compare how fast dolutegravir lowers the HIV viral load~     in these three different sites. In addition, investigators seek to learn if there are any~     differences in how dolutegravir acts in males and females. Results of this study will provide~     more information about HIV medications and their limitations. In the future, this could help~     create better HIV medications that can get into these hard-to-reach places and eventually~     cure HIV infection.~   "
49090|NCT02924376|"~     The purpose of this study is evaluate the efficacy of INCB054828 in subjects with~     advanced/metastatic or surgically unresectable cholangiocarcinoma with FGFR2 translocation~     who have failed at least 1 previous treatment.~   "
49091|NCT02924363|"~     The purpose of this study is to use cardiac magnetic resonance (CMR) and echocardiography to~     define the anatomic and functional remodeling that results from MitraClip implantation. A~     total of sixty (60) patients undergoing MitraClip implantation will be enrolled across~     multiple sites. The severity of mitral regurgitation, cardiac morphology and function will be~     assessed in these patients by taking cardiac magnetic resonance imaging with an FDA approved~     contrast agent at BASELINE (within 30 days prior to MitraClip implantation), during the ACUTE~     REMODELING PHASE (pre-discharge following implantation), and during the CHRONIC REMODELING~     PHASE (6 months post-implantation).~   "
49092|NCT02924350|"~     This single center study will investigate the efficacy of an experimental stannous fluoride~     containing dentifrice in relieving DH compared with a standard fluoride dentifrice after~     short term use.~   "
49093|NCT02924337|"~     The purpose of this study is to assess the effect of a single therapeutic dose and a single~     supra-therapeutic dose of imeglimin on the QT/QTc interval~   "
49095|NCT02924311|"~     The main objectives of this observational study are to describe outcomes, monitoring and~     treatment patterns of patients with diabetic macular edema in routine clinical practice who~     are either treatment naïve patients or previously treated patients. The total study~     population will be evaluated as well as the two subgroups (previously treated patients and~     treatment naïve patients).~      This study is designated to answer French Health Authority (HAS Haute Autorité de Santé)~     requirements.~   "
49096|NCT02924298|"~     In the past two decades, the prevalence of obesity in the US has increased from 23.2% to~     32.9%. This epidemic is fueling the Chronic Kidney Disease (CKD) epidemic. This likely is the~     major challenge facing the nephrology community in the next decade and beyond. This pilot~     study is designed to test the feasibility of the Sit Less, Interact, Move More (SLIMM)~     intervention and to determine its preliminary impact on light physical activity (PA) levels.~     Increasing light PA may have significant impact on both obesity and slowing the progression~     of CDK.~   "
49097|NCT02924285|"~     For therapy of symptomatic premature ventricular complexes (PVCs) in subjects with structural~     heart disease the current European Guidelines for the management of patients with ventricular~     arrhythmias and the prevention of second cardiac death recommend catheter ablation as well as~     amiodarone with a class IIa indication. Due to the lack of randomized data this study~     investigates the comparison of catheter ablation and amiodarone for PVC treatment in patients~     with structural heart disease. Therefore, patients will be randomized to one of two treatment~     strategies: 1) catheter ablation, or 2) amiodarone.~   "
49098|NCT02924272|"~     The purpose of this study is to provide continued access to ixazomib and evaluation of the~     long-term safety profile of ixazomib.~   "
49099|NCT02924259|"~     The purpose of this study was to examine the effects of a foam rolling intervention on~     pressure pain thresholds (PPT) of the ipsilateral antagonist and contralateral muscle groups.~     Through this research we sought to gather data to further develop the methodology for future~     studies of this intervention.~   "
49100|NCT02924246|"~     Rationale: Oral vaccination is known to induce a systemic immune response as well as an~     immune response in mucosal tissues, and can therefore serve as a model to study systemic and~     mucosal immunity. In this study, the oral cholera vaccine Dukoral® was chosen as model~     vaccine. The kinetics of the immune response and the interaction with a raw milk matrix have~     been evaluated in a previous, pilot study (NL49042.081.14). Based on the outcomes of this~     pilot, in this study oral cholera vaccination will be applied to study the support of~     immunity by raw milk, compared to heat-treated milk. The study design has been optimised~     based on previous results: study duration is extended and sample size is based on relevant~     change and known variation in the primary outcome parameters.~      Infections are an important worldwide cause of death, both in elderly and young children.~     Therefore, support of immunity could help to reduce the incidence of infections. To screen~     the potential of specific foods or food ingredients to support immunity, oral vaccination can~     serve as a model. In a previous study, this model was developed using oral cholera~     vaccination in human adult volunteers. In that study, raw milk was shown to support the~     immune response to vaccination. In this follow-up study, the effect of raw milk will be~     compared with pasteurized and ultra-heat treated (UHT) milk.~      Objective: To investigate whether pasteurized milk and/or UHT milk are able to enhance the~     immune response as induced by oral cholera vaccination, in comparison to raw milk and to~     regular vaccination.~      Study design: The study is designed as a single-blind randomized controlled trial of 6 weeks.~      Study population: Healthy subjects of 18-50 years of age.~      Interventions: 1) Raw milk, obtained from farms that comply to the high quality requirements~     for production of raw milk, and that has been screened according to the safety criteria for~     raw milk; 2) commercially available full-fat UHT milk; 3) commercially available full-fat~     pasteurized milk.~   "
49101|NCT02924233|"~     This is a phase 1b/2b study investigating the safety and preliminary antitumor effects of~     Sym004 in combination with nivolumab versus nivolumab monotherapy when administered every~     second week.~   "
49102|NCT02924220|"~     Listeriosis is a rare, severe foodborne infection caused by the bacterium Listeria~     monocytogenes (Lm). It manifests as septicemia, central nervous system (CNS) infection and~     maternal-fetal (MF) infection. Its associated overall mortality is very high, above of 30%. A~     better knowledge on the factors involved in its occurrence and in clinical manifestations is~     therefore needed to improve outcome.~      A number of frequent acquired risk factors for listeriosis have been identified, such as~     pregnancy, diabetes, cancer, HIV infection, and immunosuppressive therapies. However, no~     genetic study on host susceptibility to listeriosis in humans has been performed so far, in~     the absence of prospective collection of patients' samples. Also, listeriosis diagnosis is~     based on Lm culture from clinical samples. This method lacks sensitivity, and the~     contribution of biomarkers to listeriosis diagnosis and prognosis has not been evaluated.~      The Multicentric Observational NAtional Analysis of Listeriosis and Listeria (MONALISA), is~     the first national case-control prospective study on listeriosis. It is implemented since~     2009 and enrolls all culture-proven cases declared to the NRCL: and collects for each patient~     clinical and biological data and biological samples. Controls with comparable background and~     presentation are also included. 818 cases have been included (427 S, 252 CNS and 107 MN) over~     3.5 years, along with 456 controls.~      The aim of the study is to identify human genetic susceptibility factors to listeriosis,~     biomarkers to improve its diagnosis and prognosis (survival or death), and thereby help~     improve management of patients with listeriosis.~      Samples from the completed cohort will be analyzed : SNPs genotyping and exam sequencing;~     biomarkers a identification in serum and plasma of patients and controls by simultaneous~     multi-analyte and metabolomic profiling.~   "
49103|NCT02924207|"~     To determine the impact of an electronic decision support tool on physician decision making~     and patient outcomes for the treatment of poorly controlled diabetes mellitus. Primary~     endpoint will measure change in hemoglobin A1c. Secondary endpoints will examine cost of~     therapy and patient satisfaction with therapy. Study hypothesis is that use of the PATH~     decision tool will produce greater reduction overall in measurements of hemoglobin A1c in~     patients who participate and follow the PATH decision tool than patients who elect not to~     follow the PATH decision tool. PATH decision tool will provide more cost effective solutions~     for management of diabetic medication than current methods.~   "
49104|NCT02924194|"~     The purpose of this study is to evaluate the safety and effectiveness of deep brain~     stimulation of the nucleus basalis of Meynert (also called the nbM) at improving memory in~     Parkinson's disease patients with mild cognitive impairments and memory difficulties.~     Patients with Parkinson's disease (PD) that are eligible for Deep Brain Stimulation (DBS)~     therapy for improvement of their motor symptoms and with evidence of mild cognitive~     impairments and memory difficulties will be enrolled.~   "
49136|NCT02923778|"~     This phase II trial studies the side effects of talimogene laherparepvec and radiation~     therapy and to see how well they work in treating patients with newly diagnosed soft tissue~     sarcoma that can be removed by surgery. Biological therapies, such as talimogene~     laherparepvec, use substances made from living organisms that may stimulate or suppress the~     immune system in different ways and stop cancer cells from growing. Radiation therapy uses~     high energy x-rays, photons. electrons, or protons to kill tumor cells and shrink tumors.~     Giving talimogene laherparepvec and radiation therapy may work better in treating patients~     with soft tissue sarcoma.~   "
49105|NCT02924181|"~     Pulmonary vein (PV) isolation is very important in atrial fibrillation (AF) catheter~     ablation. PV reconnection is one of the main reasons in AF recurrence. Contact force-sensing~     catheter is a new catheter which has valuable tools to monitor and increase the efficacy of~     PV isolation. Previous paper reported the efficacy of contact force-sensing catheter on~     immediate PV isolation and outcome. However, there might be confounding factor as~     inter-individual variation. Therefore, we would like to compare the efficacy of contact~     force-sensing catheter within same patient but different veins.~      In this study, we would like to confirm the efficacy of contact force-sensing catheter on~     immediate PV isolation outcome within same patient. This study randomized the right or left~     PVs whether to use the contact force-sensing function or not. The study design will minimize~     the inter-individual variation on evaluating the efficacy of contact force-sensing catheter~     on immediate PV isolation.~      Also, in patients who had recurred AF or AT, we would like to evaluate the long-term efficacy~     of contact force-sensing catheter on PV isolation.~   "
49106|NCT02924168|"~     This is a double blind randomized clinical trial to evaluate the effect of radial shock waves~     on functional recovery of the upper limb of patients with sequelae of ischemic strokes in the~     territory of the middle cerebral artery. A total of 20 patients will be enrolled and will~     undergo motor, functional and cortical excitability evaluations before and after four weekly~     sessions of radial shockwaves. 5,000 pulses with a frequency of 15 Hz and 3.5 to 4 bar of air~     pressure will be applied to the active group, resulting in an energy flux density (EFD) of~     approximately 0.07 mJ/mm2. The sham group will receive identical treatment, except for the~     fact that no energy flux will be applied.~   "
49107|NCT02924155|"~     This study is a randomized, double-blind, placebo-controlled, single day/multiple day dosing,~     Phase I clinical trial to investigate the systemic exposure, safety and local tolerability of~     SJP002 ophthalmic solution in healthy Korean male volunteers.~   "
49108|NCT02924142|"~     PICOTS:~      P: Kennedy class І patients~      I : Mandibular removable partial denture with OT Cap attachment~      C: Mandibular removable partial denture with gingival approaching clasp assembly~      O: 1ry outcome: Oral Health Related Quality of Life~      2ry outcome: Biting force~      T: 1 Year~      S : Randomized control trial~      Research question:~      In Kennedy class І patients will the removable partial denture with OT Cap attachment~     compared to conventional removable partial denture with clasp assembly results in difference~     in Oral Health Related Quality of Life of Patients?~   "
49109|NCT02924129|"~     The purpose of this study is to evaluate the safety and efficacy of the Saluda Medical Evoke~     SCS System with feedback control to treat chronic pain of the trunk and/or limbs.~   "
49110|NCT02924116|"~     The purpose of this study is to determine the effects of the Bioboosti device on sleep for~     patients who have been diagnosed with insomnia.~   "
49111|NCT02924103|"~     A test of a newly designed device (Contamination free bacterial swab). This device can be~     used to introduce a standard bacterial swab into the nose without direct or indirect contact~     with the nasal vestibule.~   "
49112|NCT02924090|"~     This is a randomized controlled study assessing the effect of pre-emptive hyperventilation on~     ECT seizure duration, cerebral desaturation and remission of depressive symptoms in patients~     with Major Depressive Disorder. Comparison of etomidate and ketamine on remission of~     depressive symptoms with and without pre-emptive hyperventilation will also be studied.~   "
49113|NCT02924077|"~     Study was a non-interventional, prospective study of pregnant women who agreed to provide~     information about their medication use and certain lifestyle factors on a periodic basis~     throughout their pregnancy. Volunteers were recruited by measures such as placement of~     pamphlets near pregnancy test kits in pharmacies and by links from carefully selected~     websites and social networking sites. Subjects were invited to learn about the study either~     through visiting the study web site or phoning a telephone number where a recorded message~     described the study and invite eligible women to register for participation.~      Participants were asked whether they prefer to provide data via the internet or by~     interactive voice response system (IVRS).~      Data were collected in the predominant natural languages of the four study countries:~     Denmark, the Netherlands, Poland, and the United Kingdom (UK).~      Data were collected on use of prescription and non-prescription medication, as well as on use~     of herbals and homeopathic medications. More information was be collected from women who~     provided their response over the internet than by phone, in order to best utilize the full~     capacity of internet- based data collection.~   "
49114|NCT02924064|"~     This study is designed as a prospective, multi-centre, parallel group, double-blind~     randomized, placebo-controlled, phase 3 clinical study to evaluate the efficacy and safety of~     MP-513 (Teneligliptin) in combination with metformin.~   "
49115|NCT02924051|"~     Healthy eating can be difficult for people who live in poor, geographically isolated regions~     of the United States. In particular, people who live in Appalachia often experience food~     insecurity (i.e., their access to adequate food is limited by a lack of money and other~     resources at times during the year) and lack of access to healthy foods. This pilot study~     evaluates the effectiveness of motivational interviewing in helping individuals who live in~     these austere regions improve their diets in the context of limited resources and healthy~     food availability~   "
49116|NCT02924038|"~     This is a pilot, randomized, two arm neoadjuvant vaccine study in human leukocyte antigen-A2~     positive (HLA-A2+) adults with World Health Organization (WHO) grade II glioma, for which~     surgical resection of the tumor is clinically indicated. Co-primary objectives are to~     determine: 1) the safety of the novel combination of subcutaneously administered IMA950~     peptides and poly-ICLC (Hiltonol) and i.v. administered CDX-1127 (Varlilumab) in the~     neoadjuvant approach; and 2) whether addition of i.v. CDX-1127 (Varlilumab) increases the~     response rate and magnitude of CD4+ and CD8+ T-cell responses against the IMA950 peptides in~     post-vaccine peripheral blood mononuclear cell (PBMC) samples obtained from participating~     patients.~   "
49148|NCT02923609|"~     The primary objective of the study is to investigate safety and efficacy of transendocardial~     CD34+ cell therapy in patients with HFpEF by evaluating changes in myocardial structure and~     function, myocardial perfusion and electrical activity, biomarkers of neurohormonal~     activation, patient exercise capacity and clinical outcome.~      The secondary objective of the study is to better define the patophysiological background of~     HFpEF by the use of multimodality imaging platform, which will include data from~     electro-anatomical mapping, cardiac MRI, 2D and 3D echocardiography, high resolution~     electrocardiography, and cardiac catheterization~   "
49117|NCT02924025|"~     The aim of the study is to examine if motivational interviewing can have a positive effect on~     weight loss over a 6 month period. By losing weight, the investigators assume the patients~     will have a positive effect on quality of life, and also that weight loss will help to~     regulate the factors that are present with polycystic ovary syndrom (PCOS); such as menstrual~     disorders and infertility.~      Participants will be randomly assigned to a treatment group and a control group.~      Both groups will be followed as normal with blood samples and other tests such as scans of~     the ovaries and measurement of height and weight at the beginning of the study and after six~     months.~      In addition, there will be a small hair sample taken from the neck at the first consultation~     and after 6 months. This is done to measure the stress hormone cortisol in the body over the~     duration of the experiment.~      The treatment group receive individual motivational interviews by a nurse every 14 days for a~     period of six months. After half a year, tests are repeated to see if there are significant~     differences between the groups.~   "
49118|NCT02924012|"~     The aim of this study was to determine the energy demand and the potential to promote reduce~     blood pressure of an active video game (AVG). Fourteen hypertensive (56.4 ± 7.5 years) held a~     session AVG and traditional sedentary video game sessions (SVG) and walk (WAL), as negative~     and positive controls, in order determined randomly. During the sessions, they were observed~     oxygen consumption and energy expenditure (EE). Blood pressure (BP) and cardiac autonomic~     modulation (CAM) were measured at rest and every 15 minutes of a 60 minute period of recovery~     activities. It was also applied a rating scale of pleasure (enjoyment scale).~   "
49119|NCT02923999|"~     A randomised phase I trial of a monoclonal antibody which neutralises HIV-1 (P2G12) to be~     given as a single intravenous infusion to healthy human volunteers to assess the safety and~     reactogenicity~   "
49120|NCT02923986|"~     The primary objective of the Phase 1b study is to determine the dose-limiting toxicity (DLT)~     and maximal tolerated dose (MTD) of BP1001 and Dasatinib (Das) in patients with Philadelphia~     chromosome positive (Ph+) Chronic Myelogenous Leukemia (CML) in accelerated or blast phase.~     The primary objective of the Phase IIa study is to assess the efficacy of the combination of~     BP1001 and Das in patients with Ph+ CML.~   "
49121|NCT02923973|"~     Preterm birth (PTB) is a major cause of perinatal morbidity and mortality. Worldwide, about~     15 million babies are born too soon every year, causing 1.1 million deaths, as well as short-~     and long-term disability in countless survivors. Few prognostic tests are available to~     predict PTB. A short transvaginal ultrasound cervical length (TVU CL) has been shown to be a~     good predictor of PTB.Different strategies have been adopted for prevention of PTB. The~     evidence supports the use of vaginal progesterone in singleton pregnancies with short cervix,~     while cervical cerclage seems to be beneficial only in the subgroup of singleton gestations~     with both prior spontaneous PTB and TVU CL ≤25mm, and not in singletons without prior PTB,~     nor in multiple gestations.~      However, so far there are no level-1 data on the efficacy of TVU CL screening neither in low~     risk nor in high risk pregnancy Thus, the investigators aim to assess the efficacy of a~     policy of TVU CL screening in singleton pregnancy with prior spontaneous PTB~   "
49122|NCT02923960|"~     This is a randomized, double blinded, multi treatment, crossover study intended to compare~     the glycemic and insulinemic response after consuming liquid nutritional products in people~     with type 2 diabetes.~   "
49123|NCT02923947|"~     The purpose of this study is to assess the effect of severe renal impairment on the levels of~     AZD9291 in the blood in patients with advanced solid tumours compared to patients with normal~     renal function~   "
49124|NCT02923934|"~     The three tumour streams that will be studied in this protocol are: (i) upper GI malignancies~     (comprising intra-hepatic/extra-hepatic cholangiocarcinomas,gall bladder cancers and duodenal~     cancers).); (ii) neuroendocrine tumours (inc. Pancreatic, bronchial and intestinal carcinoid~     tumours) and (iii) rare gynaecological tumours (including but will not be limited to: vaginal~     or vulval carcinomas, clear cell carcinoma of the ovary, low grade serous ovarian cancer,~     mixed mullarian tumours (carcinosarcoma), sarcomas of the female genital tract and granulosa~     cell tumours).~      The role of immunotherapy is being defined in more common cancer types, however because of~     their rarity, the efficacy of immunotherapy for these cancers is poorly defined.~      This protocol provides an important opportunity to establish whether the combination of~     nivolumab & ipilimumab has efficacy in these cancers.~   "
49125|NCT02923921|"~     To compare the efficacy of AM0010 in combination with FOLFOX versus FOLFOX alone in patients~     with metastatic pancreatic cancer as measured by overall survival~   "
49126|NCT02923908|"~     The study is designed to see if, after tasting specific things, whether a child's facial~     pattern and voice pattern can determine the difference in something that has a sweet taste,~     no taste, and a bitter taste. The investigators will do this by comparing video recordings of~     a child's facial expression and voice to the child's response to follow-up questions after~     tasting three (3) different substances.~   "
49127|NCT02923895|"~     This single centre study will be used to investigate the efficacy of an experimental stannous~     fluoride containing dentifrice in relieving dentinal hypersensitivity (DH) after short term~     use compared with a standard fluoride dentifrice.~   "
49149|NCT02923596|"~     Purpose of this retrospective study is to review and analyze the information and data that~     has been already been generated during the course of routine practice of medicine by the~     investigators from 2007 up until Sept 1, 2016 from keloid patients who have sought medical~     care or medical advice for their keloid disorder.~   "
49150|NCT02923583|"~     The purpose of this study is assess the pharmacokinetics and safety of M834 and Orencia ®~     following administration of a single-dose in healthy volunteers.~   "
49151|NCT02923570|"~     Compared to IMRT, PBRT is thought to give less radiation exposure to the surrounding healthy~     tissues. It is possible that side effect rates with PBRT will be lower or the same compared~     to IMRT, but this has not been well studied to date. Although both of these radiation~     therapies have been used in the past to treat head and neck cancer, this research study will~     compare the effects of these two different radiation treatment modalities with each other to~     see whether PBRT is better, the same or worse than IMRT.~   "
49152|NCT02923557|"~     This clinical trial is designed to evaluate the efficacy of single immediate intravesical~     chemotherapy instillation in the prevention of bladder recurrence after nephroureterectomy~     for primary upper tract urothelial carcinoma (UTUC) patients.~   "
49128|NCT02923882|"~     Low-birth-weight (LBW) is a major adverse pregnancy outcome in resource-poor countries. About~     28% of all neonatal deaths worldwide are directly attributed to LBW. Exposure to biomass fuel~     during cooking is associated with LBW. There is unlikely to be any significant change in the~     use of biomass fuels in the near future, therefore, interventions targeted to reduce the~     harmful effects on poor pregnancy outcomes is warranted. To address this need, the~     investigators proposed a locally-made inexpensive prefabricated model of the~     100-dollar-kitchen($100Kitchen) with an improved cookstove for resource-poor settings. The~     improved cookstove of the $100Kitchen ensure complete incineration of the biomass fuels and~     thus, provided safeguard to the pregnant women using these fuels. This study has been~     measured the impact of our '$100Kitchen and improved cookstove' intervention as to whether a~     pregnant woman residing in a household with a '$100Kitchen and improved cookstove' is less~     likely to give birth to a LBW newborn. A cluster-randomized controlled trial has been adopted~     in Shahjadpur sub-district in Bangladesh and 628 and 639 pregnant women at 8-12 weeks~     gestational age enrolled for each intervention and control area respectively and followed-up~     through 42-days post-delivery. Birth outcomes have been noted and the newborns have been~     weighted within 72-hrs of the delivery. Non-invasive maternal blood Carbon Monoxide~     Hemoglobin saturation (SpCO) level between the intervention and control groups have also been~     measured.~   "
49129|NCT02923869|"~     A cleft deformity of the lip and/or palate is one of the commonest major birth defects.~      Primary surgery of cleft palates (CP) varies according to the different surgical teams. Its~     peculiarity lies in the numerous care management protocols proposed according to the surgical~     techniques used, operating time (between M3 and M18 of life), anesthetic technique and~     postoperative management.~      This surgery must be associated to a specific care management because of potential associated~     complications, especially the risk of obstruction of the upper respiratory tract and~     respiratory distress majored by the use of morphine anesthetics during and after surgery.~      Adequate postoperative analgesia in children is a vital part of perioperative care. Regional~     block given preoperatively in combination with general anesthesia (GA) provides good~     preemptive analgesia. It is associated with perioperative hemodynamic stability, rapid and~     complete recovery and reduced analgesic requirement in the postoperative period.~      CP repair is painful, necessitating high doses of intravenous (IV) opioids. Therefore, the~     risk of postoperative respiratory depression and airway obstruction is important, and~     continuous monitoring is required during the initial 24-h postoperative period. Cleft palate~     surgery is not only painful, but may also compromise the airway, particularly in children~     with craniofacial syndromes. Opiate analgesia has the potential to further compromise the~     airway, whereas bilateral maxillary nerve block can provide analgesia without the risk of~     respiratory depression in these vulnerable patients. Bilateral maxillary nerve block is~     performed using a suprazygomatic approach and is based on a computer tomography study.~      The nerve supply to the hard and soft palate is from the greater and lesser palatine nerves~     passing through the sphenopalatine ganglion. The maxillary nerve (MN) provides sensory~     innervation of the anterior and posterior palate, the upper dental arch, the maxillary sinus,~     and the posterior nasal cavity. Maxillary nerve block (MNB) through the infrazygomatic route,~     used for the treatment of trigeminal neuralgia in adults, permits anesthesia of the entire~     palatine territory. However, this nerve block has led to complications such as orbital~     puncture, intracranial injection, maxillary artery puncture, or posterior pharyngeal wall~     injury.~   "
49130|NCT02923856|"~     As the resistant rate of the Helicobacter pylori to some common antibiotics was rising，the~     eradication rate of the Helicobacter pylori with the standard triple therapy failed to exceed~     70% in China，and had to drop out of the first-line treatment recommendations. However, with~     the increase of treatment time, patients burden, adverse reactions of antibiotics or proton~     pump inhibitor (PPI) will also increase. Resistance to clarithromycin is the major cause of~     the failure to eradicate Helicobacter pylori. But, in terms of population, there are still~     more than 70% of the patients with clarithromycin sensitive. Under the guidance with~     susceptibility test，7-day standard triple therapy could be used. In this study, investigators~     will select the patients with infection of H. pylori and with clarithromycin sensitive.~     Eradication of Helicobacter pylori with triple therapy based on accurate susceptibility~     testing of clarithromycin will be studied. The treatment time will be assigned into 7 days,10~     days and 14 days groups. Then, investigators will perform a sequencing for failed treatment~     patients in groups, such as drug resistance gene mutation, phenotype and genotype. Finally,~     investigators will compare the differences between the patients with triple therapy and~     traditional quadruple therapy.The incidence of adverse effects in the eradicate treatment~     will reduce at least 10% and avoid patients' unnecessary economic losses at least 400RMB per~     person.~   "
49131|NCT02923843|"~     Frailty and multimorbidity is one of the biggest challenges of todays health care due to the~     demographic development with more and more elderly surviving many diseases that was mortal~     just a few decades ago. Health care in Sweden is one of the best in the world, yet many frail~     older people do not receive appropriate health care. Several reports have described a~     fragmented care with lack of good quality due to lack of a holistic view on the patient and~     her situation. At the same time the care given is costly and ineffective with a lack of~     continuity. Additionally, there are a lack of hospital beds in Sweden due to the ageing~     population and a cut down of beds in the last decades.~      There is though a method, Comprehensive Geriatric Assessment (CGA), where studies have shown~     many benefits for older patients including less need of hospital beds, better functional~     outcomes and a better chance of living at home after an Acute Hospital Discharge, but this~     method is not much used in Sweden.~      The aim of this study is to show that CGA in an Out-patient Care Setting save hospital beds~     without decreasing the quality of care measured by sustained functional capacity. Other~     parameters to be evaluated are mortality, degree of frailty, health economy, quality of life,~     and cognition.~   "
49132|NCT02923830|"~     The purpose of this study is to determine the safest and most effective flushing solution for~     maintaining patency (unobstructed flow) in BioFlo implanted port catheters. The complication~     rate in patients whose ports are flushed with saline only will be compared to the~     complication rate in patients whose ports are flushed with a combination of saline and~     heparinized saline.~   "
49133|NCT02923817|"~     The purpose of study is to determine whether autologous mononuclear cells deriving from the~     bone marrow are effective in the treatment of spinal cord injury.~   "
49134|NCT02923804|"~     This study is a prospective, randomized, placebo-controlled, double-blind trial to determine~     the effect of high concentrate omega-3 capsules on the omega-3 status of patients with~     non-alcoholic fatty liver.~   "
49135|NCT02923791|"~     This study compares the potential immunogenicity of two filgrastims, the proposed biosimilar~     Filgrastim Hospira (US) and the US-approved Neupogen reference product. Subjects will receive~     doses of one of the two filgrastims by injection of 5 micrograms/kilogram (mcg/kg). Subjects~     will receive 5 consecutive daily doses in Period 1 (Days 1-5) and a single dose on Day 1 of~     Period 2. Pre-dose and serial post-dose assessments of immunogenicity will be conducted each~     of the two study periods. In addition, safety assessments will be conducted throughout the~     study.~   "
49137|NCT02923765|"~     Stroke rehabilitation of hemiplegics primarily lies in motor control and training of~     activities of daily life. Whole body aerobics is much less emphasized. Nonetheless,~     cardiopulmonary fitness of even ambulatory hemiparetics is only half compared with healthy~     people, which is prone to deconditioning. The present study aims to understand the efficacy~     of aerobic training in addition to the usual neuro-rehabilitation, including aerobic fitness,~     daily activities dependency, anti-inflammation and anti-thrombosis. This is a prospective and~     randomized design. The subjects will be recruited from the hospitalized patients in the~     rehabilitation ward of Chang Gung Memorial Hospital at Linkuo. 120 hemiplegic patients due to~     stroke will be enrolled and randomized into two groups: combined training (CT) and usual~     rehabilitation. Participants in CT will receive aerobics at moderate intensity in addition to~     the usual rehabilitation. The program has 35 minutes/session, 5 sessions/week and 4-5 weeks~     in total. A constant-power semi-recumbent stepper will be employed as the training modality.~     It uses bilateral reciprocal movement of the arm coupled with the opposite leg, which allows~     for a push and pull motion. Additional 20 healthy participants will also be recruited as the~     healthy control. Assessment before and after training includes: (I) graded cardiopulmonary~     exercise test using constant-load stepper. (II) Functional Independence Measure. (III)~     coagulation system assessment, using Thrombin generation assay and Ceveron alpha (Technoclone~     GmbH, Vienna, Austria) : Von Willebrand factor, tissue plasminogen activator, plasminogen~     activator inhibitor-1, D-dimer, factor VIII, etc. [the 1st year]; (IV) monocyte-platelet~     aggregation and its subtypes, using flow cytometry [the 2nd year]. ( V) systemic~     inflammation, platelet activation and prognostic biomarker：C-reactive protein, soluble~     P-selectin, asymmetric dimethylarginine, Lipoprotein-Associated Phospholipase A2, etc [the~     3rd year]. Statistical analysis will use ANOVA with post-hoc, two-way repeated measure ANOVA,~     etc. The investigation will start after approval and end in 2019, July. We hope this~     investigation will establish a more comprehensive rehabilitation program for clinical~     application.~   "
49138|NCT02923752|"~     This is a new vessel wall imaging-based stroke registry which will investigate the clinical~     utility of the whole-brain intracranial vessel wall Magnetic Resonance Imaging (MRI)~     technique in assessing the etiologies in patients with ischemic stroke.~   "
49139|NCT02923739|"~     The goal of this clinical research study is to learn if adding emactuzumab to the combination~     of paclitaxel and bevacizumab can help to control relapsed or refractory ovarian, fallopian~     tube, or primary peritoneal cancer. The safety and side effects of this drug combination will~     also be studied.~   "
49140|NCT02923726|"~     The primary objective is to understand the role of antitachycardia pacing (ATP) in primary~     prevention patients indicated for ICD therapy and programmed according to current guidance of~     higher rate cut-offs and therapy delays. The time to first all-cause shock will be tested in~     subjects with standard therapy (ATP and shocks) compared to subjects programmed to shock only~     to assess equivalency.~   "
49141|NCT02923700|"~     Platelet-rich Plasma (PRP) is the most exploited biologic agents currently used for the~     treatment of osteoarthritis (OA) of different joints, in particular knee OA.~      In previous studies, it has been showed its potential to reduce pain and improve functional~     status in patients treated by simple intra-articular injections. However, there are several~     PRP formulation currently available in clinical use, and therefore it is very difficult to~     compare data coming from trials using different products. The most debated aspect concerning~     PRP formulation is the role of leukocytes, which might stimulate an early inflammatory~     response in the joint due to the release of metalloproteases and other pro-inflammatory~     cytokines.~      The investigators hypothesized that the presence of leukocytes in PRP could be clinically~     relevant in terms of outcome, so the present double blind randomized controlled trial was~     designed to compare leukocyte-rich and leukocyte-poor PRP injections for the treatment of~     knee OA.~      A power analysis has been performed for the primary endpoint of IKDC (International Knee~     Documentation Committee) subjective score improvement at the 12-month follow-up for PRP. From~     a pilot study, a standard deviation of 15.2 points was found. With an alpha error of 0.05, a~     beta error of 0.2 and a minimal clinically significant difference of 6.7 points corresponding~     at 1/3 of the documented mean improvement, the minimum sample size was 83 for each group.~     Considering a possible drop out of 15%, 96 patients per group are required for total 192~     patients, selected according to well-defined inclusion criteria (see 'Eligibility criteria'~     section). Patients are then assigned to two different treatment groups, according to a~     randomization list. The first group of treatment consists of three weekly intra-articular~     injections of autologous leukocyte-rich PRP, whereas the second group of patients will be~     treated by three intra-articular injections of leukocyte-poor PRP.~      PRP will be obtained with the following procedure: a 300-ml autologous venous blood sample~     will undergo 2 centrifugations (the first at 1480 rpm for 6 minutes to separate erythrocytes,~     and a second at 3400 rpm for 15 minutes to concentrate platelets) to produced 20 ml of~     leukocyte-rich PRP. In case of patients allocated to receive leukocyte-poor PRP, a special~     filter will be then used to separate leukocytes and obtain leukocyte-poor PRP.~      The total amount of PRP will be divided into 4 small units of 5 ml each. One unit is sent to~     the laboratory for analysis of platelet concentration and for a quality test, 3 units are~     stored at -30° C.~      One week after the PRP production, the injective treatment starts, with 3 weekly injections.~     At the moment of the injection the syringe is properly covered to prevent the patient from~     discovering the substance he was receiving. After the injection, patients are sent home with~     instructions to limit the use of the leg for at least 24 h and to use cold therapy/ice on the~     affected area to relieve pain. During this period, the use of non-steroidal medication is~     forbidden.~      Patients are prospectively evaluated basally and at 2, 6, and 12 months of follow-up using~     clinical subjective scores and objective parameters to determine clinical outcome (see~     'Outcome measure' section). Patient satisfaction and adverse events will be also reported.~     All the clinical evaluations are performed by a medical staff not involved in the injective~     procedure, in order to keep the study double blinded. At the end of the study, the nature of~     the injected substance is revealed to the patients.~   "
49142|NCT02923687|"~     Objective: The aim of this study is to evaluate premedication with ketorolac infiltration on~     post endodontic pain in patients with symptomatic irreversible pulpitis.~      Design: Randomized double blind clinical trial~      Setting and conduct: Sixty adult volunteers with including criteria will be divided into two~     groups (n=30) based on random table. All patients will receive standard inferior alveolar~     nerve block of 2% lidocaine with 1:800000 epinephrine and supplemental buccal infiltration of~     0.9 mL 2% lidocaine with 1:800000 epinephrine. After five minutes one group will receive~     supplemental buccal infiltration of 30 mg/mL of Ketorolac Tromethamine and the control group~     will receive buccal infiltration of normal saline. Endodontic access preparation will~     initiate after 15 minutes of initial IANB with two negative responses to the electric pulp~     test. The pain level will be recorded immediately and at the 2,4,6 and 24 hours following the~     treatment using Heft- Parker Visual Analog Scale (HP- VAS). Data will be evaluated using~     Repeated measured test (if possible) and otherwise non-parametric tests such as rival~     Friedman and X2 test. Participants including major eligibility criteria: all patients age~     ranged 18-65 with symptomatic irreversible pulpitis (HP VAS ≥54) and without pain on~     percussion on a mandibular molar tooth who need root canal treatment and are without systemic~     diseases; nonsmoking; non pregnant, non breast feeding without any medicine consumption or~     analgesic and sedation~      Intervention: Ketorolac infiltration~      Main outcome measures: Pain level at immediately after the treatment, 2, 4, 6 and 24 hours~     following the root canal treatment using HP VAS.~   "
49143|NCT02923674|"~     This study will help determine the appropriate type, amount and intensity of physical~     activity most beneficial for preventing weight regain after weight loss in older adults.~   "
49144|NCT02923661|"~     this study was conducted to clarify the effect of two different attachments on patient~     satisfaction and marginal bone loss. The primary and secondary objectives are to determine~     patient satisfaction and the marginal bone loss around implant when using CM LOC compared to~     conventional ball attachment. all the patients will receive a single median implant to which~     the denture will be loaded upon using the two different attachment systems~   "
49145|NCT02923648|"~     Obstructive lung disease is an increasing global health problem of pandemic proportions, with~     COPD alone affecting >10% of the population. Smoking is the main and most well studies risk~     factor for developing COPD. However, chronic airway obstruction also in never-smoking~     populations has recently been recognized as an increasing health problem. Prematurely born~     children, particularly survivors of bronchopulmonary dysplasia (BPD), defined as the need for~     oxygen therapy up to the 28th day of life for children born prior to gestational week 32,~     have an increased incidence of both airway obstruction and hyper-reactivity, both~     representing major risk factors for developing COPD, or asthma, later in life. The purpose of~     this study is to perform in-depth clinical and molecular characterizations of of the lungs of~     survivors of BPD as they enter adulthood, and compare these profiles to relevant control~     groups (individuals with mild asthma, healthy prematurely born, and healthy individuals born~     at full term). Specifically, alterations at the epigenetic, mRNA, microRNA, protein and~     metabolite level as well as associated molecular pathways critical in the pathological~     mechanisms of obstructive lung disease related to premature birth and BPD will be identified.~   "
49146|NCT02923635|"~     The aim of this study is to asses the oncological safety of oncoplastic breast surgery, and~     its impact on patient satisfaction.~   "
49147|NCT02923622|"~     Although patients of colorectal cancer use Traditional Chinese Medicine (TCM) herbal therapy~     extensively in China, no strong evidence exists to demonstrate the safety and survival~     outcomes of TCM herbal therapy combined with conventional western medicine for treatment of~     this disease. The purpose of this multi-center perspective cohort study is to evaluate the~     relationship between TCM herbal therapy and survival outcomes in patients with advanced~     colorectal cancer.~   "
49167|NCT02923362|"~     Prospective registry comparing outcomes after laparoscopic treatment of gastroesophageal~     reflux disease and hiatal hernia.~   "
49153|NCT02923544|"~     The purpose of this study is to test the feasibility and safety of using a new device called~     Yukio's Uterine Manipulating Instrument (YUMI). The YUMI is a type of uterine manipulator. It~     is a reusable metal device designed to be simple and study. It is also adjustable in size~     which makes it easy for surgeons to use. It will be placed at the beginning of the surgery~     and removed at the end. This study will allow the researchers to find out if the surgeons~     find the YUMI effective and easy to use. It will also allow the researchers to see if the~     device is safe. This is the first time that the YUMI is being used in humans.~   "
49154|NCT02923531|"~     The purpose of this study is to determine if the combination of X4P-001 plus nivolumab is~     safe and tolerable. Secondly, the study will investigate if adding X4P-001 to nivolumab~     treatment has an effect on the body and the cancer tumor, in patients receiving nivolumab but~     not exhibiting a radiological response.~   "
49155|NCT02923518|"~     In 2010 there was published new European recommendations for assessment of adult and elderly~     men and women, who want to start with physical activity and/or participate in endurance~     contests. In this study we want to test if a group of people with positive score on a~     self-reported questionnaire and/or high-risk score in a risk scoring system (NORRISK) have~     more undetected heart diseases than a control group with no reported or detected risk~     factors.~   "
49156|NCT02923505|"~     The aim of the study is to test the hypothesis that treatment of sleep disordered breathing~     (SDB) in patients with comorbid chronic obstructive pulmonary disease (COPD) and/or heart~     failure (HF) with positive airway pressure (PAP) is associated with reduced risk for~     hospitalizations and death, lower health care utilization, and greater cost-effectiveness.~   "
49157|NCT02923492|"~     The translation study aims to refine and package intervention and training materials~     essential to translating an efficacious Emergency Department (ED) based Brief Intervention~     (BI) for violence (SafERteens) for two delivery methods: by ED staff on site or by therapist~     remotely. The study will take place in two phases. During the Effectiveness phase, we will~     determine the effectiveness of the interventions [on-site therapist delivered BI + text~     messages (n=133); remote therapy delivered BI + text messages (n=133)], as compared to a~     usual care control (brochure; n=133), on violence outcomes at 3 months. Note that tailored~     text messages will be delivered daily for the first month post-discharge, and three times per~     week in the second month post-discharge to the BI groups. During the Implementation phase,~     components of the RE-AIM model will be assessed over a 4-month period.~   "
49158|NCT02923479|"~     The purpose of this trial is to determine the effectiveness, safety and tolerability of~     robot-assisted rehabilitation using ARBOT in patients with ankle dysfunction resulting from~     work related ankle fractures, compared with conventional rehabilitation programs.~   "
49159|NCT02923466|"~     This is a Phase 1 multi-center study designed to determine the maximum tolerated dose (MTD)~     and toxicity of intratumoral administration of VSV-IFNβ-NIS in patients with refractory~     advanced/metastatic solid tumors.~   "
49160|NCT02923453|"~     Objective: We aim to evaluate longer term efficacy and safety of AG as an add-on therapy in~     patients with type 2 diabetes controlled by conventional treatment. Materials and Methods: A~     total of 23 type 2 patients are enrolled in the study. Utilizing a double-blind, crossover~     design, the participants are randomized to receive either placebo or American ginseng extract~     (AG) 1g/meal=3g/day for 8-week, while maintained on their conventional diabetes treatment.~     Following ≥4-week washout period the participants are crossed over to another 8-week~     treatment arm. Throughout the study period, all individuals maintain their original diabetes~     treatment and regular lifestyle. The primary endpoint is HbA1c, and secondary are fasting~     blood glucose and insulin, blood pressure, serum nitrates/nitrites (NOx) and PAI-1. Safety~     parameters include liver, kidney and hemostatic functions.~   "
49161|NCT02923440|"~     Congenital heart defects are seen in 0,8% of life births. In France this means more than 5000~     newborns per year. The south-east region of France is particularly affected as a result of a~     higher birth rate and consanguinity, when compared to other regions. The majority of~     congenital heart diseases remain unexplained. Genetic causes are indisputable but remain~     poorly understood. Genetic research needs the availability of a large-scale DNA collection,~     guided by a robust phenotypic classification. Such a DNA-bank has been created in Paris~     (CARREG DNA bank, created by the M3C reference centre for congenital heart diseases). Such a~     bank is currently unavailable in south-east France. To transport biological specimens from~     Marseille to Paris would be very expensive. In addition, the whole infrastructure required~     for correct diagnosis and classification of the congenital heart diseases, for sampling, for~     storage of the samples and genetic analysis, does exist in our AP-HM hospital and in our AMU~     research unit. For those reasons it is highly preferable to elaborate such a database and~     DNA-bank locally. The acronym SEA-HD (South-EAst-Heart-Diseases) would be used to name this~     DNA-bank~   "
49162|NCT02923427|"~     To compare the effects of i-gel and Laryngeal mask airway Supreme (LMA-Supreme) on~     ventilation parameters and surgical view during Trendelemburg Position laparoscopic~     gynecological surgery in cases administered positive pressure ventilation without the use of~     neuromuscular agents.~   "
49163|NCT02923414|"~     Atrial fibrillation is the most common heart rhythm disorder. For patients suffering atrial~     fibrillation direct current cardioversion is performed to reduce patients symptoms and~     prevent disease progression. The optimal energy selection for biphasic cardioversion is~     unknown.~      We aim to investigate the efficiency and safety of a high energy shock protocol (360 J)~     versus a standard escalating shock protocol (125-150-200 J) in cardioversion of atrial~     fibrillation.~   "
49164|NCT02923401|"~     The goal of this research study is to learn if there is a level of exercise training that is~     more effective in lowering biomarker levels that are linked to breast cancer risk. Biomarkers~     are found in the blood/tissue and may be related to your reaction to exercise.~      This is an investigational study. Up to 72 participants will be enrolled in this study. All~     will take part at MD Anderson.~   "
49165|NCT02923388|"~     This study will be conducted to evaluate the effect of vitamin B12 and vitamin B6 in delaying~     the onset and reducing the incidence and severity of Vincristine Induced Peripheral~     Neuropathy (VIPN) in Acute Lymphoblastic Leukemia (ALL) patient.~   "
49166|NCT02923375|"~     The purpose of this study is to assess the safety, tolerability and efficacy of two infusions~     of CYP-001 in adults with steroid-resistant GvHD.~   "
49170|NCT02923323|"~     Study population : 90 Participants. 60 with T1DM , and 30 healthy controls. T1DM patients~     will be recruited by research publication in diabetes mellitus forums.~      Baseline visit: informed consent signing. Medical history data, vital signs, physical exam~     and neurocognitive testing. Capillary glucose prior to testing > 70 mg/dl.~      Session 2 - combined simultaneous EEG , continuous glucose monitor system (CGMS) assessment,~     neurocognitive testing, and sleep quality assessment.~      Participants will be hospitalized for 30 hours in the continuous-EEG unit at the Pediatric~     Neurology Department, Assaf-Harofeh Medical Center. Continuous simultaneous EEG and CGMS~     monitoring, and two separate sessions of neurocognitive assessments at glucose > 240 mg/dl~     and at glucose < 180 mg/dl, respectively.~      Neurocognitive assessment will be performed after lunch on day 1, and after lunch on day 2.~     Day 1, regular insulin dose before lunch, and a cognitive assessment which will be performed~     with glucose level > 70 mg/dl and below 180 mg/dl.~      On day 2, with no regular insulin dose before lunch and the same cognitive test will be~     performed with glucose level > 240 mg/dl During the 30 hours the participants will be~     connected to continuous EEG recording, sleep monitoring and CGMS. The study participants and~     research team will be blinded to the EEG and CGMS readings while recorded.~      Participants will be able to convey their daily activities in their room. They will have~     their regular diet and regular daily activities.~      Participants will measure at least 4 blood glucose measurements by prick tests, insulin~     management by multiple daily injections or pump therapy and meals.~      Healthy participants will measure twice daily as required for CGMS calibration. The~     participants will stay connected to the CGMS for additional 4 days at their home setting for~     complete sleep quality assessment by sleep diary and actigraph.~      The first night in hospital is to assess the association between actigraph and EEG and CGMS~     variability. The 4 nights at home are for assessment of CGMS, quality of life and actigraph~     readings.~      Control group (healthy) will perform only one session of neurocognitive studies on day 1,~     after lunch with no insulin injection and will be discharged after 24 hours, with the CGMS~     and actigraph~   "
49171|NCT02923310|"~     OOsteoarthritis (OA) is a chronic joint disease characterized by progressive degeneration of~     cartilage and bone tissue, leading to the appearance of subchondral cysts, osteophyte~     formation and synovial inflammation. Although the causes of OA are still poorly understood,~     biomechanical stresses able to reach the articular cartilage and subchondral bone,~     biochemical changes in cartilage and synovial membrane, as well as genetic factors are~     important items in its pathogenesis. Although there is no cure for OA, treatment is directed~     to each individual patient, seeking to minimize pain, maintain or improve joint range of~     motion and limit disability. New therapies able to accelerate regeneration and tissue repair~     process are being discussed. The viscosupplementation with hyaluronic acid (HA) have been~     shown to be an effective and safe treatment alternative in the fight against knee OA, in~     addition to HA, worth highlighting the therapeutic effects of growth factors derived from~     autologous platelets. The platelet-rich plasma (PRP) appears as an autologous therapy,~     non-immunogenic, able to induce healing and repair of bone soft tissue. This study aims to~     evaluate the clinical efficacy, comparing treatment with PRP and the combination of HA and~     PRP in the treatment of knee OA. To this, 120 will be selected OA patients with mild,~     moderate and severe (Grade II, III and IV). Selected patients will be scheduled for the~     procedures and randomly assigned randomly. In PRP be determined concentrations of the growth~     factor PDGF, TGFb 1, VEGF, EGF, by the method Bio Plex®.\. Functional evaluations will be~     conducted through questionnaires (WOMAC and SF-36) as measures of function and quality of~     self-reported life. The walking and strength test will be performed before and during periods~     of 90.180 and 360 days after the first application. The main motivation for the development~     of this study is the lack of randomized, double-blind clinical studies in the literature, and~     also based on the favorable results researchers have obtained, both with the use of HA, as~     the use of PRP in accelerating the process scar, preventing the development of arthrosis~     above. Therefore, we believe that the PRP, with its growth factors associated with synthetic~     HA play a synergistic action that should be studied in detail, in order to establish an~     effective therapeutic approach in the treatment of patients with knee OA.~   "
49172|NCT02923297|"~     Parkinson's disease (PD) is the most frequent neurodegenerative disorder after Alzheimer's~     disease. It is characterized by motor symptoms (rigidity, tremor, slowness of movements), and~     non-motor symptoms (neuropsychological, psychiatric, pain ...). Neuronal death initiates in~     the brainstem and extends progressively through the entire cortex. The processes leading to~     cell death are poorly understood. Pathological cells exhibit abnormal deposits, called Lewy~     bodies, which contain numerous proteins. A major constituent of these protein deposits is~     alpha-synuclein. It has recently been demonstrated, in the Laboratory of Molecular Biophysics~     of the CNRS (Scientific Research National Center) in Orleans, that α-synuclein interacts with~     Cytogaligin, a protein produced by the proapoptotic GALIG gene. Cytogaligin could thus be a~     factor regulating α-synuclein activity or aggregation. It is postulated that the level of~     expression of the GALIG gene is different in Parkinson's disease patients compared with~     control subjects.~   "
49173|NCT02923284|"~     The incidence of renal cell carcinoma (RCC or kidney cancer) in men exceeds that of~     pancreatic cancer or leukemia. In women, the incidence of RCC is similar to that of leukemia,~     ovarian, or pancreatic cancer; thus, RCC is significant health issue. This study focuses on~     identifying specific molecules [biomarkers] of RCC that can be used to develop a reliable~     low-cost screening method at the point of service. If successful, our method would provide a~     diagnostic test to distinguish benign kidney masses from malignant ones, eliminating the need~     to surgically remove a kidney with a benign tumor.~   "
49174|NCT02923271|"~     Research participants and their parents will be recruited to take part in a randomized~     control trial. Participants' and their parents' cellphone use will be observed during an~     initial baseline period. Participants and their parents will then be randomly assigned to one~     of two conditions: opt-out blocking with parental notification, opt-out blocking with~     bidirectional notification.~   "
49175|NCT02923258|"~     This is a randomized,controled, phase III, open label study of postoperative concurrent~     chemoradiotherapy with Docetaxel versus Cisplatinum for high-risk squamous cell carcinoma of~     the head and neck(HNSCC).The primary purpose of this study is to evaluate the efficacy and~     safety of concurrent chemoradiotherapy with docetaxel in HNSCC patients.~   "
49176|NCT02923245|"~     The purpose of this study is to assess the accuracy and utility of point-of-care ultrasound~     (POCUS) of the bladder compared to patient's sensation of bladder fullness in predicting the~     ability to successfully perform a comprehensive transabdominal pelvic ultrasound in the~     pediatric Emergency Department (ED). We hypothesize that POCUS can more accurately and more~     quickly determine adequate bladder fullness to successfully perform transabdominal pelvic~     ultrasound than patient's perception of bladder fullness.~   "
49177|NCT02923232|"~     Presbyopes (people who might have a significant loss of their ability to accommodate their~     crystalline lens in the eye) will be recruited to wear a test lens and perform typical~     clinical tests of visual acuity with different luminance levels and viewing distances/angles.~   "
49178|NCT02923219|"~     The purpose of this study is to determine whether the adipose-derived stem cells therapy is~     effective in the treatment of facial rejuvenation.~   "
49179|NCT02923206|"~     This clinical investigation is a medical device trial to examine the safety and efficacy of~     TheraSorb sFlt-1 adsorber treatment of pregnant patients with preeclampsia.~   "
49192|NCT02923037|"~     This pilot clinical trial studies Hatha yoga in reducing physical and emotional problems in~     breast cancer survivors with stage II-III lymphedema. Yoga practices may benefit breast~     cancer survivors with lymphedema as they directly support lymph transport (postures,~     breathing, relaxation) and emotional well-being (relaxation, meditation).~   "
49180|NCT02923193|"~     Shockwave Medical Inc. intends to conduct a prospective, multi-center, single blind,~     randomized (1:1) study of Lithoplasty treatment used in combination with DCB versus standard~     balloon angioplasty used in combination with DCB to treat moderate and severely calcified~     femoropopliteal arteries. Assuming that roughly 15% of the subjects will be~     lost-to-follow-up, a total of 334 subjects (167 per treatment arm) will be enrolled in the~     study.~      In addition to the randomized study, an observational study of subjects who do not meet the~     inclusion/exclusion criteria for the randomized study will be conducted. The objective of the~     observational study is to assess the real-world acute performance of the Shockwave Medical~     Peripheral Lithoplasty System in the treatment of calcified, stenotic, peripheral arteries.~      The observational study is a prospective, multi-center, single arm observational study for~     subjects who do not meet the inclusion/exclusion criteria of the randomized study.~      A maximum of 250 subjects at the same 50 sites will be enrolled in the observational study.~   "
49181|NCT02923180|"~     This study evaluates the safety, anti-tumor effect, and immunogenicity of Enoblituzumab given~     before radical prostatectomy. All patients will receive Enoblituzumab for 6 weekly doses~     beginning 50 days prior to radical prostatectomy.~   "
49182|NCT02923167|"~     This is an intervention study including a baseline data collection, 6 weeks of a training~     intervention with robotic-assisted manual training and a post-intervention data collection.~     The study will be conducted in the Motion Analysis Laboratory at Spaulding Rehabilitation~     Hospital, Boston, MA.This study aims to assess the effectiveness of a robot-assisted training~     on hand function and quality of life in children with cerebral palsy. Additionally, the~     investigators will study the relationship between muscle synergies and the outcomes of~     robot-assisted training.~   "
49183|NCT02923154|"~     The purpose of this study is to investigate the efficacy, safety, tolerability and~     pharmacokinetics of multiple oral administration of MT-3995 in patients with NASH.~   "
49184|NCT02923141|"~     The Purpose of this study is to see if it is possible to deliver an intervention that targets~     trauma, substance use, and engagement in HIV care with HIV-positive women.~   "
49185|NCT02923128|"~     The purpose of this study is to determine whether postoperative analgesia pump continuous~     infusion of dexmedetomidine are effective in the prevention of Postoperative delirium and~     Postoperative cognitive dysfunction.~   "
49186|NCT02923115|"~     This is a Phase 1b, double-blind (Principal Investigators, study subjects, Sponsor, Academic~     Research Organization ARO and Clinical Research Organization CRO blinded),~     placebo-controlled, randomized, single-ascending dose, multi-center study to assess the~     safety, efficacy, tolerability, pharmacokinetics PK, and pharmacodynamics PD of DS-1040b in~     subjects with acute submassive pulmonary embolism.~   "
49187|NCT02923102|"~     The aim of the study is to investigate a pre and post workout supplementation (15 days) with~     Recoverben® , a Aloysia citriodora extract on recovery after exhaustive exercise. Effects~     will be investigated with 400mg Recoverben® and compared to placebo.~   "
49188|NCT02923089|"~     This study will recruit 20 healthy adults (male and female) to complete 9 study visits where~     they will consume different food products (chili, soup and muffin) with or without lentils~     incorporated into the them. Blood samples will be obtained by finger prick before and for 2~     hours after the meal and analyzed for glucose and insulin.~   "
49189|NCT02923076|"~     Allogeneic hematopoietic cell transplantation from a CCR5 Δ32/Δ32 unrelated donor, performed~     for the first time in the Berlin patient, provides the only evidence to date of long-term~     control of HIV infection. Stringent criteria to select human leukocyte antigen (HLA)-matched~     conventional donors and low prevalence of the CCR5 Δ32/Δ32 homozygous genotype (<1%) made the~     pursuit of patient number 2 unsuccessful for many years. Cord blood (CB) transplantation~     allows more permissive HLA-matching criteria, making the search for HLA-compatible Δ32/Δ32 CB~     units potentially feasible for transplantation of HIV-infected individuals.~      The investigator team involved in this trial has recently reported the first such case of~     CCR5 delta32/delta32 CB transplantation in a patient with HIV infection, showing a reduction~     of the patient's latent viral reservoir and, upon achievement of full CB chimerism,~     resistance of his CD4 T-lymphocytes to infection by HIV. This proof of concept led the~     Spanish National Transplant Organization (ONT) to generate an inventory of over 150 CCR5~     Δ32/Δ32 CB units readily available for transplant.~      From this initial evidence and repository of CB units, financial support from the Fundación~     Mutua Madrileña (FMM) has allowed the investigators to launch this first pilot clinical trial~     in this indication. The study was launched in January 2016 at Hospital Universitario Puerta~     de Hierro Majadahonda. All HIV virology and reservoir analyses are carried out by the AIDS~     Immunopathology Unit at the Spanish Instituto de Salud Carlos III. Three additional~     transplant centres in Spain will also shortly open the trial.~   "
49190|NCT02923063|"~     Skeletal muscle dysfunction (sarcopenia) is an under-recognized target organ complication of~     CKD with substantial adverse clinical consequences of disability, hospitalization, and death.~     Sarcopenia in this proposal is defined by impaired metabolism and physical function~     associated with decreased skeletal muscle mass or function. Skeletal muscle tissue relies on~     mitochondria to efficiently utilize oxygen to generate ATP. Impaired mitochondrial energetics~     is a central mechanism of sarcopenia in CKD. The investigators propose a series of studies~     designed to shed light on the pathophysiology of sarcopenia in persons with CKD not treated~     with dialysis. Investigators will conduct a randomized-controlled intervention trial of~     combined resistance training and aerobic exercise vs. health education to assess changes in~     skeletal muscle mitochondrial function, metabolism and physical function. Investigators~     hypothesize that exercise improves mitochondrial function and physical function in persons~     with CKD. If successful, these experiments will identify novel pathophysiologic mechanisms~     for CKD-associated sarcopenia. The proposed study will provide useful insight into benefits~     associated with exercise among patients with CKD and investigate mechanisms associated with~     improved metabolism, muscle function and physical function in population.~   "
49191|NCT02923050|"~     The purpose of this study is to determine effectiveness of a family meals intervention,~     Simple Suppers, aimed at eliciting positive changes in child dietary intake and weight~     status.~   "
49254|NCT02922218|"~     PROSENZA is a prospective multicentre study to analyse circulating and tissue biomarkers that~     may predict prognosis and response in patients with CRPC treated conventionally with~     Enzalutamide.~   "
49193|NCT02923024|"~     Oscar spends a significant amount of money every year on high cost high need individuals.~     With this increase in health care spending, Oscar Health is looking to expand care post~     emergency room and inpatient utilization for their members. In order to reduce hospital~     readmissions, reduce emergency room utilization, and increase the overall health of their~     members, Oscar is investing in a program to bring members better care through increased~     engagement with their primary care physician.~   "
49194|NCT02923011|"~     Osteoid osteomas are painful, benign bone tumors that occur most frequently in young males~     between ages 10 and 20 years. The goal of the proposed study is based on the premise that~     MRgFUS is noninferior to CT-guided radiofrequency ablation (CTgRFA), in terms of pain~     reduction following treatment of osteoid osteomas, and offers possible improvements with~     regards to 1) post-procedural pain, 2) clinical resource utilization, 3) patient experience,~     and/or 4) adverse events. The data from the current study would provide clinicians important~     information in deciding between treatment options for ablation of osteoid osteomas.~   "
49195|NCT02922998|"~     The purpose of the study is to find out whether CD64 expression on neutrophils measured by a~     new bedside test (LeukoDx) within 30 minutes is associated with effective antibiotic therapy~     in critically ill adult patients at risk of sepsis.~   "
49196|NCT02922985|"~     Opioid use and abuse has become a major medical problem in the United States. Over~     prescription of opioid medications is a major contributor to this growing problem. Cesarean~     delivery (CD) is the most commonly performed surgery in the US and women are generally given~     opioid medications for postoperative pain management. This is not a common practice in other~     developed countries. The investigators believe that a multimodal pain management strategy is~     superior to current practices for control of postoperative pain after CD and will lead to a~     decrease in the use of opioid medications. This will have beneficial effects on patients'~     recovery and bonding with their newborns, as well as societal effects in reducing the burden~     of opioid abuse in the US. The objective is to investigate the use of a multimodal pain~     regimen in pregnant patients undergoing CD. This is a randomized double-blinded, placebo~     controlled trial. The multimodal intervention consists of a pre-operative dose of intravenous~     (IV) acetaminophen (Ofirmev), infiltration of subcutaneous bupivacaine prior to skin~     incision, and a dose of intramuscular (IM) ketorolac at time of fascia closure. These study~     medications are currently used in the patient population but not in a standardized fashion,~     not in every patient, and not always in combination with each other. The control group will~     receive placebo IV infusion preoperatively and an IM injection at fascia closure, and~     subcutaneous infiltration with normal saline before skin incision. Both groups will receive~     spinal regional anesthesia as per anesthesia team. Post-operatively, both groups will receive~     the current standard of care, which consists postoperative hydrocodone/acetaminophen and~     ibuprofen as needed depending on pain score. The primary outcome of interest will be the~     total opioid intake in the first 48 hours after surgery. Secondary outcomes include time to~     first opioid requested, pain scores at 6-12, 24 and 48 hours post op, and total number of~     opioid tablets left after discharge on post op day number 7. Additional outcomes include~     patient satisfaction scores and total length of hospital stay. The hypothesis is that our~     multimodal pain regimen will decrease the total opioid requirement in the first 48 hours~     after surgery.~   "
49197|NCT02922972|"~     The aim of this prospective study is to assess the efficacy of autologous Platelet Rich~     Plasma prepared with RegenKit-BCT in the prevention and the treatment of keloid scars~     refractory to conventional treatments. Fifteen patients were included and received three PRP~     injection sessions with a one-month interval. The outcomes were assessed at baseline (before~     treatment), 3, 6, 12 and 24 months after the last injection session. Safety was assessed by~     reported adverse event analysis.~   "
49198|NCT02922959|"~     This project will further develop and test the Tailored Telephone Intervention delivered by~     Peers to Prevent Recurring Opioid Overdoses (TTIP-PRO), a promising, low-cost, intervention~     to facilitate entry into medication assisted treatment (MAT) for individuals experiencing a~     non-fatal opioid overdoses (OOD). A prior small-scale pilot/feasibility study of TTIP-PRO~     (NCT02282306) found that the participating patients and the Peer Interventionists were~     satisfied with their participation, the intervention was acceptable, and the system for~     generating patient-tailored intervention information performed well. The overall goal of the~     present study is to conduct a pilot randomized controlled trial of TTIP-PRO versus a control~     group. It is hypothesized that patients in the TTIP-PRO group will have more favorable~     drug-abuse-related outcomes than patients in the control group.~   "
49199|NCT02922946|"~     The objectives of this study are to evaluate the effect of the timing of a moderate-fat meal~     on the single dose pharmacokinetics of entinostat and to evaluate the safety and tolerability~     of entinostat under fed and fasting conditions in healthy adult subjects.~   "
49200|NCT02922933|"~     The purpose of this study is therefore to evaluate the effect of concomitant drugs known to~     affect solubility of drugs through increase of intra-gastric pH levels on the bioavailability~     of entinostat.~      The primary objectives of this study are to evaluate the effect of multiple doses of~     omeprazole, famotidine, and the effect of an acidic beverage on the single-dose PK profile of~     entinostat.~      The secondary objectives are to evaluate the safety and tolerability of a single dose of~     entinostat when administered with multiple doses of omeprazole, famotidine, and when~     administered with an acidic beverage.~   "
49201|NCT02922920|"~     Tart cherries are a rich source of antioxidants. Studies have shown that tart cherries exert~     anti-oxidative and anti-inflammatory properties. The purpose of this study is to learn about~     the effects of drinking tart cherry juice on cardiovascular and cognitive health.~   "
49202|NCT02922907|"~     Double-blind placebo-controlled randomized trial of Arabinoxylan Rice Bran Supplementation~     for 12 weeks with BRM4 in HIV-infected participants with inadequate immune reconstitution.~   "
49203|NCT02922894|"~     This study will investigate potential therapeutic approaches for sleep-disordered breathing~     (SDB) in patients with chronic cervical spine injury (>6 months post-injury).~   "
49204|NCT02922881|"~     Ulcerative colitis is a chronic inflammatory disease primarily involving the colon and has~     long been considered to be due to a dysregulated immune response targeting the colon, and~     involves unknown environmental factors. Currently, no effective therapy targets the~     microbiota or its interaction with the colonic epithelium. Diet has a significant impact on~     the composition of the microbiota; however, no dietary intervention to date has proven~     effective for induction of remission. The primary objective of this study is to determine~     whether the Ulcerative Colitis Diet (UCD) can induce remission or response in pediatric UC~     patients with active mild to moderate UC on a stable medication.~   "
49205|NCT02922868|"~     The purpose of this research study is to compare the effectiveness and efficiency of using a~     sterile sheath (EndoSheath®) during cystoscopy versus a standard scope.~   "
49281|NCT02921867|"~     The investigators hypothesise that simulation-based training will have initial educational~     benefits and in coherence with the traditional apprenticeship model will heighten the~     educational end-level: That training on the simulator before clinical education will prepare~     the trainee for practice and thereby support more effective learning.~   "
49206|NCT02922855|"~     A randomized controlled trial (RCT) of incentives for an initial primary care visit within 6~     months of enrollment in a health care coverage program. Study subjects are drawn from a~     low-income adult population that gains coverage and access to community-based primary care~     services under a program administered by an academic safety-net hospital. The investigators~     will offer financial incentives to encourage an initial primary care visit within 6 months of~     enrollment and evaluate whether the primary care visit altered subsequent health seeking~     behavior and influenced patient satisfaction and other outcomes such as self-reported health~     status.~   "
49207|NCT02922842|"~     The purpose of the study is to compare patient centered- outcomes between Transcutaneous~     Electrical Nerve Stimulation (TENS) at three locations to treat urinary urge incontinence.~     One of these locations will be along the tibial nerve, which is traditionally accessed near~     the medial malleolus. The second site will be on the sacral nerve which is accessed over the~     sacrum. The third site will be a sham site on the shoulder. This study will evaluate the~     feasibility of transcutaneous electrical stimulation in the treatment of overactive bladder.~   "
49208|NCT02922829|"~     The Prenatal Nutrition and Psychosocial Health Outcomes (PreNAPS) study was a two year~     collaboration between Gulu, Makarere, Cornell, and Tufts Universities. The PreNAPs study's~     primary goals were: a) to determine the differential impacts of food insecurity on~     gestational weight gain and prenatal depression, and b) to elucidate the mechanisms~     underlying the relationship between food insecurity and weight gain and/depression among HIV~     infected and HIV uninfected pregnant women in Gulu, Northern Uganda.~   "
49209|NCT02922816|"~     Transplant patients are at increased risk of colonization and infection with Multidrug~     Resistant Organisms (MDROs) due to medications that modify their immune systems, increased~     healthcare and antibiotic exposure, and surgical manipulation of mucosa. In this study,~     kidney transplant patients who have infections with resistant bacteria will be given a Fecal~     Microbiota Transplant (FMT), also known as a fecal transplant, after they receive antibiotic~     treatment. This study will see if FMT will eliminate the resistant bacteria so that the~     kidney transplant patients do not have to use last resort antibiotics.~      This Phase 1 pilot study is to obtain preliminary safety data for FMT in renal transplant~     patients to support the rationale for a subsequent clinical trial, not to establish efficacy~     or toxicity. This trial is designed to test the safety of FMT, identify clinical outcomes,~     assess feasibility, and refine the target population in participants with MDRO colonization~     and intestinal dysbiosis. Data from this study should provide directions for the design of~     future clinical trials.~   "
49210|NCT02922803|"~     Somali migrant women, often in veiled clothing, living in a town in mid Sweden on the 60:th~     parallel were observed to be weak and to have a waddling gate.~      Study 1 was carried out in the setting of an antenatal clinic administered from a primary~     care center in Borlänge, a Swedish middle-sized industrial town at the 60:th parallel in~     Sweden. The investigators chose an initial study period in late spring to reflect the effects~     of the dark season with little ultraviolet B radiation that affects vitamin D production.~     Study 1 was carried out in a short period of time. The recruitment was performed in a~     retrospective design in order to neglect the seasonal effects of ultraviolet B radiation.~     Study 1 was carried out in year 2010. It was a cross sectional baseline study of blood levels~     of vitamin D measured as 25-hydroxyvitamin D (25-OHD) and physical performance in 123~     pregnant and new mothers from Somalia (n=52) and Sweden (n=71).~      Study 2: Examines the results on muscular performance, i.e. grip strength and squatting~     ability, from intervention with advice and prescription of vitamin D3 and calcium for 10~     months, in all the women from study 1 with 25-OHD levels <50 nmol/L or 50 nmol/L of 25-OHD.~      Study 3: The recruitment to Study 1 also serves as recruitment for a cohort study on delivery~     outcome in birth protocols starting 2016.~      Study 4: The aim is to study the emic perspective and lifestyle related to vitamin D and~     strength in the group of Somali women by focus interviews among the Somali women from above.~      A possible fifth study will explore correlations between 25-OHD and pain distribution and~     pain parameters.~   "
49211|NCT02922790|"~     The purpose of the study is to explore how feedback of cellular DNA (Deoxyribonucleic Acid)~     damage, as a marker of exposure to the genotoxic agents of tobacco smoke, promotes cessation.~   "
49212|NCT02922777|"~     This study is being done to evaluate the safety of the investigational study drug, BGB324~     when administered in combination with docetaxel, and to establish the maximum tolerated dose.~   "
49213|NCT02922764|"~     Study RGX-104-001 is a Phase 1, first-in-human, dose escalation and expansion study of~     RGX-104, an oral small molecule targeting the liver X receptor (LXR), as a single agent and~     in combination with nivolumab. RGX-104 activates LXR, resulting in depletion of both~     myeloid-derived suppressor cells (MDSCs) as well as tumor blood vessels. MDSCs block the~     ability of T-cells and other cells of the immune system from attacking tumors.~      During the dose escalation stage, multiple doses and schedules of orally administered RGX-104~     with or without nivolumab (single agent or combination therapy) will be evaluated in patients~     with advanced solid tumors and lymphoma (i.e., locally advanced and unresectable, or~     metastatic) who have had progressive disease (PD) on available standard systemic therapies or~     for which there are no standard systemic therapies of relevant impact.~      In the expansion stage of the study, additional patients with epithelial ovarian carcinoma~     (EOC), melanoma, non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), renal~     cell cancer (RCC), bladder cancer (BLC), or triple negative breast cancer (TNBC) will be~     treated at the MTD (or maximum tested dose if no MTD is identified, or dose below the MTD if~     there is evidence suggesting a more favorable risk/benefit profile). This stage will provide~     further characterization of the safety, efficacy, PK, and pharmacodynamics, including~     biomarkers of immunologic activity and LXR target activation, of RGX-104 as a single agent~     (EOC) and in combination with nivolumab (melanoma, NSCLC, SCLC, RCC, BLC, and TNBC).~   "
49214|NCT02922751|"~     Noninvasive monitoring of liver fibrosis is an unmet need within the clinical management of~     pediatric chronic liver disease. While liver biopsy is often used in the initial diagnostic~     evaluation, subsequent biopsies are rarely performed because of inherent invasiveness and~     risks. This study will evaluate the role of non-invasive FibroScan™ technology to detect and~     quantify liver fibrosis.~   "
49215|NCT02922738|"~     Health care providers use a variety of computerized medical information sources to reduce~     knowledge gaps and support patient care decisions. Few studies have evaluated the impact of~     medical information sources on patient outcomes. Skin problems are the reason for many visits~     to primary care providers and result in a high percentage of referrals to dermatologists and~     return visits to primary care for the same skin problem.~      The objective is to evaluate the impact of primary care providers' use of a dermatology~     information source, VisualDx, on skin problems outcomes.~      The study design is a cluster-randomized controlled trial. Participants include primary care~     providers as clusters and their patients with skin problems. Providers are randomized to~     intervention group that refers to VisualDx when seeing a patient with a skin problem, or to~     the control group who does not. Patients have the randomized group status of the doctor they~     saw for the problem.~      Patients are interviewed to determine the problem status and how many follow-up visits they~     had for the problem at intervals after the index visit.~   "
49216|NCT02922725|"~     The investigators propose to determine if 8 weeks of dietary augmentation with oral 5g~     creatine monohydrate daily and 100 mg of 5-hydroxytryptophan (5-HTP) twice daily reduces~     hypoxia-related depressive symptoms measured by the 17-item Hamilton Depression Rating Scale~     (HAM-D) in women with SSRI- or SNRI-resistant depression, combined with the examination of~     changes in functional connectivity based on resting-state fMRI and changes in brain~     metabolism inferred from phosphorus-31 magnetic resonance spectroscopy.~   "
49217|NCT02922712|"~     Study is conducted to evaluate safety and efficacy in patients with osteoarthritis~   "
49218|NCT02922699|"~     Comparison of efficacy of H.pylori eradication during first line therapy using standard or~     high doses of omeprazole administered twice daily in combination with amoxicillin and~     clarithromycin for 10 days.~   "
49219|NCT02922686|"~     The main objective of this study is to investigate the non-inferiority of oral flucloxacillin~     alone compared with a combination of oral flucloxacillin and phenoxymethylpenicillin for the~     emergency department directed outpatient treatment of cellulitis, wound infections and~     abscesses, recently renamed by the Food and Drug Administration (FDA) as acute bacterial skin~     and skin structure infections (ABSSSIs). Half of the trial participants will receive~     flucloxacillin and placebo in combination, and the remaining half will be treated will~     flucloxacillin and phenoxymethylpenicillin.~      In a secondary objective the trial aims to measure adherence and persistence of trial~     patients with outpatient antibiotic therapy. In addition a within-trial evaluation of the~     cost per quality adjusted life year (QALY) gained from the use of oral flucloxacillin~     compared with combination therapy from the perspective of the health-care payer (direct~     costs) the patient and government. Finally the study will externally validate the Extremity~     Soft Tissue Infection-score, a Health Related Quality of Life (HRQL) questionnaire designed~     to quantify the impact of cellulitis, wound infections and abscesses on patient HRQL in~     clinical trials.~   "
49220|NCT02922673|"~     Rationale:~      The last years, research focus has moved to immunostimulatory agents in order to restore or~     increase the functionality of the immune system during sepsis-induced immunoparalysis.~     Epidemiologic data show that prehospital use of low dose acetylsalicylic acid (ASA) is~     associated with improved outcome of sepsis. Experimental data indicate that ASA exerts~     pro-inflammatory effects during systemic inflammation. However, it remains to be determined~     whether treatment with ASA improves immune function once immunoparalysis has developed and~     whether prehospital use of low dose ASA prevents the development of immunoparalysis. In the~     former case, ASA is a potential immunostimulatory therapy that can treat sepsis-induced~     immunoparalysis. In the latter case, ASA may have a broader indication as an immunomodulating~     agent. Taken together, ASA might be a promising, cheap, well-known, and globally available~     agent to reduce the incidence of secondary infections and improve patient outcome in sepsis.~      Objective:~        -  To determine whether acetylsalicylic acid treatment can reverse endotoxin tolerance,~          which is expressed as a decrease in pro-inflammatory cytokine levels between the first~          and second endotoxin challenge.~        -  To determine whether acetylsalicylic acid prophylaxis can prevent endotoxin tolerance,~          which is expressed as a decrease in pro-inflammatory cytokine levels between the first~          and second endotoxin challenge.~      Study design:~      Double-blind randomized placebo-controlled pilot study in 30 healthy male volunteers during~     repeated experimental endotoxemia. All subjects will receive a 14 day course of study~     medication (low-dose ASA or placebo) and undergo experimental endotoxemia (lipopolysacharide~     (LPS), E.Coli type O113) on day 7 and on day 14. LPS is administrated using an initial bolus~     of 1ng/kg followed by continuous infusion at 1ng/kg/hr during 3 hours.~      Subjects are randomized in three study arms:~        1. Treatment group: 7 days placebo / first endotoxemia / 7 days ASA 80 mg (loading dose on~          first day of 160mg) / second endotoxemia~        2. Prophylaxis group: 7 days ASA 80 mg (loading dose on first day of 160mg) / first~          endotoxemia / 7 days ASA 80 mg / second endotoxemia~        3. Placebo group: 7 days placebo / first endotoxemia / 7 days placebo / second endotoxemia~   "
49221|NCT02922660|"~     This is a single-center, randomized, prospective research which aims to investigate the~     advantages and disadvantages between desflurane balanced anesthesia and TIVA-TCI with~     propofol in ophthalmic ambulatory surgery, so that to evaluate a better anesthesia method in~     ophthalmic surgery through a large sample clinical study.~   "
49222|NCT02922647|"~     The urpose of this study is to compare the urinary tract infection rate on the four~     postoperative day between the 2 groups of patients who have undergone total mesorectal~     excision for cancer and low anastomosis, with either suprapubic or transurethral~     catheterization.~   "
49223|NCT02922634|"~     The objectives of this study are to determine whether identifying patients with baseline~     cognitive deficits through preoperative cognitive screening may aid patient, family, and~     surgeon decision-making; inform and potentially improve anesthetic management and improve~     patient safety by identifying risk for postoperative morbidity.~      Aim 1. Assess the marginal benefit of structured preoperative cognitive screening relative to~     standard or systematic preoperative evaluation for identifying seniors with likely cognitive~     impairment.~      Aim 2. Determine whether preoperative cognitive impairment predicts postoperative outcome.~   "
49224|NCT02922608|"~     High fidelity simulation provide educational skills but the simulation of critical events~     could eventually provide anxiety among participants.~      The anxiety could raise before the simulation session and affect the perceived quality of~     sleep the night prior to the simulation session. The lack of sleep would eventually affect~     both participation and memorization during the simulation session. The investigators would~     like to investigate with a survey how much participants had their sleep affected before the~     simulation session.~   "
49225|NCT02922595|"~     The primary purpose of this study is to compare with a non-inferiority randomised study the~     new laryngeal tube (Intubating Laryngeal Tube Single-Disposable - iLTS-D) to the~     well-established Intubating Larygeal Mask Airway (ILMA/ Fastrach) for the success rate and~     time for intubation under fiberoptic control. Secondary purposes are success rates and times~     for ventilation for both devices and finally success rate of gastric tube placement.~   "
49226|NCT02922582|"~     This is a Phase 2, randomized, single-blind, active-controlled dose-ranging study in subjects~     scheduled to undergo total knee arthroplasty (TKA).~   "
49227|NCT02922569|"~     This study is a parallel arm, double-blind, randomized, controlled clinical trial to assess~     the safety and efficacy of an experimental software program designed to improve cognitive~     functions versus a computer-based software control. Both the study and the software being~     investigated meet the criteria of Non-Significant Risk. The primary objective of this study~     is to evaluate the effects of combination of mindfulness training (MT) and adaptive cognitive~     training (CT) on the cognitive abilities, functional status and quality of life of soldiers~     and veterans diagnosed with traumatic brain injury (TBI, also referred to as a concussion, or~     blast exposure), as compared to a computer-based control.~   "
49228|NCT02922556|"~     To assess the efficacy of a mobile-device-deployed cognitive emotional treatment for~     depression (Moodify) versus an active control treatment (commercially available computer~     games).~   "
49229|NCT02922543|"~     To understand the safety and efficacy of Revlimid® 5 mg Capsules (hereinafter referred to as~     Revlimid) in patients with relapsed or refractory multiple myeloma (hereinafter referred to~     as relapsed or refractory MM) who have received long-term treatment with it under the~     actual condition of use.~        1. Planned registration period This period started on the date of initial marketing of~          Revlimid and will end at the time when the planned number of patients to be enrolled,~          300, is reached (estimated to be approximately 1 year and 3 moths).~        2. Planned surveillance period This period started on the date of initial marketing of~          Revlimid and will end 3 years after the last enrolled patient begins receiving Revlimid~          (estimated to be approximately 4 years and 3 months).~   "
49230|NCT02922530|"~     The overall goal of this research proposal is to develop an adjunct to standard treatments~     that 'correct' disrupted neural circuitry in Parkinson's Disease (PD) patients. Directly~     treating these core deficits via targeted behavioral training should slow the progression of~     PD, assure greater resilience against future decline, and improve the quality of life of many~     living with PD. The purpose of this exploratory research study is to determine the benefits,~     if any, of the mobile device-based treatment described above in individuals with PD.~   "
49231|NCT02922517|"~     Fibrosis, myocardial deformation and biomarkers in hypertrophic cardiomyopathy (HCM)~   "
49232|NCT02922504|"~     A surgical abortion under local anesthesia is potentially painful. A protocol using analgetic~     is systematically used. Also the protocol is relevant , the question of taking care of the~     pain in a safe manner remains.~      The use of Music during surgery can have a real effect on pain and anxiety. This study has~     for goal to evalued the use of music on pain as adjuvant treatement instead of a standard~     care for an abortion.~   "
49233|NCT02922491|"~     It is a study of clinical and interventional character, in which individuals who participate~     in the intervention will be selected for convenience of the project database entitled Second~     Cycle Diagnosis and Intervention Food Situation, Nutrition and Noncommunicable Disease More~     Prevalent Population of the city of João Pessoa / PB . They will be invited to participate~     in the intervention female subjects, overweight or obese, aged 20 and 59 years. The selected~     individuals will be distributed randomly into four groups: receive daily supplementation of~     01 capsules containing 400 mg of vitamin E synthetic source (Group 1); receive daily~     supplementation of 01 capsules containing 400 mg of natural source vitamin E (Group 2);~     receive daily supplementation of 01 placebo capsule (control group); and non-intervention~     group. Individuals of intervention groups will receive dietary plan respecting individual~     needs, in order to control weight during the 08 weeks period. The subjects of the group~     without intervention, did not follow a diet plan, nor did they take vitamin E or placebo~     capsules, and were asked to continue their current eating habits over the 8-week period This~     project aims to evaluate whether vitamin E supplementation may modify the methylation and~     microRNAs profile.~   "
49234|NCT02922478|"~     This study aims to create a database of patients with stable and chronic heart failure with~     comprehensive assessment of bone, skeletal and vascular status. RoC-HF will facilitate~     cross-sectional and, eventually, longitudinal mechanistic epidemiological analyses to~     disentangle the role of the bone- vascular axis in chronic heart failure. Blood and urine~     samples will be stored to facilitate future biomarker analyses.~   "
49235|NCT02922465|"~     The primary objective of this study is to assess the effects of clopidogrel on the PK of~     K-877 in healthy adult subjects.~   "
49236|NCT02922452|"~     This study is to evaluate the effect of dilitazem on the single-dose PK of BMS-986141 with~     parameters like Cmax, AUC(INF), and AUC(0-T).~   "
49237|NCT02922439|"~     The purpose of this study will to be to evaluate the effects of a mobile intervention focused~     on improving the chronic disease self management skills of individuals with low health~     literacy. The intervention will provide information that culturally and linguistically~     tailored to participants' level of health literacy.~   "
49238|NCT02922426|"~     This study will characterize insulin sensitivity in response to treatment with ALKS 3831,~     olanzapine, and placebo.~   "
49239|NCT02922413|"~     The purpose of this study is to determine if Panhematin is safe and effective for prevention~     of acute attacks of porphyria.~      The study aims to provide high quality evidence for the use on hemin for prevention of acute~     attacks of porphyria. A separate study is in progress to evaluate the use of Panhematin for~     treatment of acute attacks of porphyria. Such studies have not been done previously for~     treating or preventing acute attacks with hemin. The lack of strong evidence for efficacy of~     hemin for treatment and prevention of attacks limits its availability for patients with acute~     porphyrias.~   "
49240|NCT02922400|"~     The primary objective of this study is to determine the efficacy and feasibility of a battery~     of neuropsychological measures evaluating social cognition and behavior in young adults~     diagnosed with schizophrenia, autism spectrum disorders, or traumatic brain injury (TBI). It~     also investigates functional differences in regions of the brain associated with social~     cognition and differences in cognitive processing. Additionally, this study implements a~     virtual reality intervention to strengthen social cognition skills.~   "
49255|NCT02922205|"~     The purpose of this observational study is to evaluate the safety and performance of the~     Endoscopic Linear Cutter Stapler and reloads from Fengh Medical used in laparoscopic~     Roux-en-Y gastric bypass surgery to create anastomoses. The goal of the study will be~     achieved by assessing the device performance and reporting of peri- and postoperative~     complications in a prospectively maintained database.~   "
49241|NCT02922387|"~     Prospective, open-label, parallel-group, 52-week trial comparing varenicline in combination~     with behavioral support with one session of behavioral support alone.~      Eligible patients were smokers hospitalized due to a) acute exacerbation of chronic~     obstructive pulmonary disease (COPD), or b) bronchial asthma attack, or c) community-acquired~     pneumonia (CAP).~      The primary outcome was the success rate (%) at week 52. Secondary outcomes were quality of~     life (QoL) alterations on the domains of the 36-Item Short Form Health Survey (SF36) and~     investigation of possible predictors for smoking abstinence.~   "
49242|NCT02922374|"~     For acute severe colitis (ASC) patients, corticosteroids (CS) was recommended as the~     first-line treatment in the guideline, but patients have a great risk of requiring colectomy~     or turning to second-line treatment. This study aim to verify the effectiveness of ulcerative~     colitis endoscopic index of severity(UCEIS) in predicting the reaction to corticosteroids,~     and explores the possibility that noninvasive marker fecal calprotectin (FC) could act as an~     alternative to UCEIS.~   "
49243|NCT02922361|"~     This project will use data from a large network-model health maintenance organization that~     operates Medicare Advantage (MA) plans (CareMore) and fee-for-service Medicare data to (1)~     better understand the characteristics of high-need, high-cost MA enrollees patients and (2)~     evaluate the impact of a care management program focused on high-need high-cost MA enrollees~     with end-stage renal disease.~   "
49244|NCT02922348|"~     The investigators intend to establish feasibility/acceptability of a pilot randomized trial~     comparing hormone replacement therapy (HRT) and combined oral contraceptives (COCs) in women~     with premature ovarian insufficiency to estimate differences in quality of life (QOL) and~     serum hormone assays and markers of bone turnover/cardiovascular risk. At baseline, QOL~     survey will be administered and serum testing performed. Patients then randomized to HRT or~     COCs. Repeat testing will be performed after 3 and 6 months.~   "
49245|NCT02922335|"~     This study's purpose is to test the effectiveness of a promising intervention for emerging~     adults (EAs) with mental illness (MI) and serious antisocial behavior in achieving the~     ultimate outcome of reduced antisocial behavior, and proximal intermediate outcomes.~     Multisystemic Therapy-Emerging Adults (MST-EA) is an adaptation of MST, a well-established,~     effective intervention for antisocial behavior in adolescents.~   "
49246|NCT02922322|"~     To analyze the effectiveness of mat Pilates compared to no intervention in individuals with~     chronic nonspecific low back pain.~   "
49247|NCT02922309|"~     People over 55 years are high-risk with voice disorders. Voice disordered elderly need vocal~     training in order to improve communication efficiency and quality of life. However,~     participation in vocal training of elderly is often restricted by motivation, time of~     practice, and availability to hospital, which thus reduces treatment effects. The purpose of~     the study is to design a telecommunication vocal training system and a vocal training program~     for voice disordered elderly in Taiwan. The investigator proposed a 3-year consecutive study,~     including a single-blind, randomized controlled trial, to test the hypothesis that vocal~     training via telepractice for voice disordered elderly are not inferior to the standard face~     to face training.~   "
49248|NCT02922296|"~     The purpose of the study is to better understand how the body handles sugars glucose and~     fats, such as cholesterol and triglycerides in sickle cell disease, and what puts certain~     persons at risk to develop diabetes. This understanding may help us to find new treatments to~     control blood sugar and prevent diabetes in people with and without sickle cell disease~     (SCD).~      In this research, DNA and RNA will be isolated from blood cells. DNA will be used to find~     genes that cause or protect from diabetes, high cholesterol and high triglyceride, and RNA~     will be used for studies designed to find out how genes are doing their job of eventually~     producing proteins.~   "
49249|NCT02922283|"~     T cell infiltration of tumor lesions is a known prognostic factor in several tumor types and~     is used as treatment mechanism in some of these tumor types. In metastatic melanoma,~     treatment with immune checkpoint inhibitors induces clinical benefit in about 30-50% of the~     patients. These immune-based therapies are however accompanied by serious immune-related~     adverse events and high costs.~      Tumor infiltrating T cells express the high affinity interleukin-2 (IL2) receptor on their~     surface. These T cells could therefore be visualized by molecular imaging with a~     radio-labelled ligand for this receptor. For this purpose, the investigators have developed~     the PET tracer [18F]FB-IL2.~      The study commences with a biodistribution study (phase 1) in 5 subjects. Thereafter the main~     study (phase 2) starts, in which 25 subjects will receive two [18F]FB-IL2 PET scans at~     baseline and week 6 of treatment with either ipilimumab, nivolumab, pembrolizumab or the~     combination of ipilimumab and nivolumab. If [18F]FB-IL2 PET is able to detect a response to~     treatment, it could serve as a non-invasive early indicator of T cell response to the~     treatment. Besides, accumulation of the PET tracer in non-target tissue could indicate~     infiltration of activated T cells in normal organs and thus may predict the development of an~     immune-related adverse event.~   "
49250|NCT02922270|"~     INTRODUCTION AND AIMS: The aims of this study were to evaluate patient and technique survival~     rates, investigate peritonitis rates and evaluate factors affecting mortality in peritoneal~     dialysis (PD) patients over a period of 20 years at Istanbul Faculty of Medicine Peritoneal~     Dialysis Unit.~      METHODS: Two hundred seventy seven patients have received PD as renal replacement therapy~     (RRT) over a period of 20 years. After exclusion of patients with follow-up shorter than 3~     months and patients whose data were not available, 250 patients were examined~     retrospectively. Data for sex, age, primary disease, comorbidities, follow up duration, cause~     of death, and cause of technique failure were collected from medical records.~   "
49251|NCT02922257|"~     This study will investigate the potential for FK506 binding protein 5 (FKBP5) (and other gene~     expression markers, for example pentraxin 3 [PTX-3], serum/glucocorticoid regulated kinase 1~     [SGK1], and glycogen synthase kinase 3 beta [GSK3b]) to be developed as a biomarker for use~     in diagnosis of Cushing's syndrome, assessment of effectiveness of medical or surgical~     treatment, and detection of relapse of endogenous Cushing's syndrome after surgery.~   "
49252|NCT02922244|"~     The herbal products on reduction of radiation-induced dermatitis in patients with breast~     cancer~   "
49253|NCT02922231|"~     Primary: To characterize the safety of RIXUBIS when used under normal clinical care in South~     Korea.~      Secondary: To describe hemostatic effectiveness in subjects receiving RIXUBIS under normal~     clinical care in South Korea.~   "
49256|NCT02922192|"~     Purpose:~      With the existing biologic anti-inflammatory product patents expiring and the FDA approval of~     new biosimilar and innovator biologics, patients with rheumatologic (RA), psoriatic~     (PsO-PsA-AS), and gastrointestinal (GI) conditions will have additional therapeutic options.~     This observational study will describe the patient characteristics of new users of Tumor~     Necrosis Factor-α (TNF) antagonists, non-TNF- α antagonists, oral DMARD, and non-biologic~     agents. It will describe in the treatment cohorts outcomes of serious infections that require~     hospitalization. The BBCIC will use the findings from this descriptive analysis to design a~     comparative study evaluating the real-world effectiveness and safety of biosimilar and~     innovator anti-inflammatory biologics.~   "
49257|NCT02922179|"~     Over the past 40 years, new types of insulins have been marketed to mirror the effect of~     endogenous insulin. With the existing long-acting insulin product patents expiring and the~     FDA approval of new biosimilar and innovator insulins, adults with diabetes and their~     physicians will have additional therapeutic options. This observational study will describe~     the patient characteristics of new and existing users of long-acting or intermediate acting~     insulins with and without oral anti-diabetic agents (OAD) as well as acute hypoglycemic~     episodes, acute cardiac events, and A1C measures. The Biologic and Biosimilars Collective~     Intelligence Consortium (BBCIC) will use the findings from this descriptive analysis to~     design a comparative study evaluating the real-world effectiveness and safety of biosimilar~     and innovator insulins.~   "
49258|NCT02922166|"~     To determine the effects of SRX246 on fear and anxiety based on fear-potentiated startle in~     humans. Additionally, the effects of the compound on emotion recognition will be explored.~   "
49259|NCT02922153|"~     The investigators propose to assess whether intra-operative intercostal cryoanalgesia using~     the cryoICE® probe (AtriCure®, Inc., 7555 Innovation Way, Mason, Ohio) provides superior~     post-operative analgesic efficacy as compared to current pain management in patients~     undergoing unilateral thoracotomy cardiac procedures.~   "
49260|NCT02922140|"~     This study aims to investigate the role of clinical pharmacist in the development of a~     pharmaceutical care program for patients with Acute coronary syndrome tailored to their~     specific learning needs and their cultural context, and to verify the program's effects on~     physiological factors and recurrent symptoms or cardiac events.~   "
49261|NCT02922127|"~     Breast cancer accounts for almost a quarter of all cancers in women. In the United States~     (U.S.) in 2014, more than 230,000 women were diagnosed and 40,000 died of breast cancer.~     There is an urgent need to develop acceptable means of preventing breast cancer both for high~     risk and average risk women.~      The proposed study is a clinical trial in premenopausal women aged 18-39 to evaluate the~     capacity of daily Ulipristal Acetate (UPA) to reduce breast epithelial cell proliferation~     (increase in number of cells in the breast) and to measure its effect compared to that found~     with a combined estrogen-progestin oral contraceptive (COC). UPA is an anti-progestin in use~     as daily medication up to 12 months for the treatment of abnormally heavy bleeding at~     menstruation due to uterine fibroids, and is currently in trials in the U.S. to evaluate its~     use as a daily contraceptive.~      The investigators will use breast biopsies to compare breast cell proliferation, comparing~     biopsies at the end of 3 months treatment to biopsies taken at baseline in the 2 groups (UPA~     and COC). The investigators will also compare the changes in the 2 groups to each other. The~     comparison of the effect of UPA to that of a conventional COC is because of UPA's potential~     use as a daily contraceptive.~      Cell proliferation in the breast occurs throughout the menstrual cycle. The actions of~     hormones on the breast are rapid and an anti-progestin such as UPA, which will block the~     action of progesterone in the breast, would be predicted to quickly lower breast cell~     proliferation in premenopausal women. Effects of UPA on the uterus continue to be studied and~     are reassuring. COC use has not been found to lower breast cell proliferation and is not~     associated with any decrease in risk of breast cancer.~      The changes in breast cell proliferation will also be compared to changes seen on breast MRI.~     If the changes are highly correlated future studies will be able to be done without the need~     for breast biopsies.~   "
49262|NCT02922114|"~     Arthritis is a current manifestation of systemic lupus erythematosus (SLE) and participates~     to the SLEDAI composite score calculation (0 to 105). Ultrasonography (US) is a validated and~     sensitive tool for joint assessment. Published studies showed US joint abnormalities in~     systemic lupus erythematosus patients with or without joint pain. Nevertheless,~     ultrasonography evaluations were not standardized and no study compared clinical and~     ultrasonography assessments. The objectives were 1) to describe ultrasonography joint~     abnormalities in systemic lupus erythematosus population, 2) to compare clinical and~     ultrasonography standardized joint assessments, 3) to estimate the reliability of clinical~     swollen joint count (C-SJC) and SLEDAI (C-SLEDAI) score versus ultrasonography-SJC and~     ultrasonography-SLEDAI.~   "
49263|NCT02922101|"~     This study evaluates the addition of a quality improvement toolbox to an online audit and~     feedback intervention in Dutch intensive care units. The toolbox comprises for each quality~     indicator (e.g., percentage of patients per shift whose pain is measured) a list of potential~     bottlenecks in the care process (e.g., staff is unaware of the prevailing guidelines for~     measuring pain every shift), associated recommendations for actions to solve mentioned~     bottlenecks (e.g., organize an educational training session), and supporting materials to~     facilitate implementation of the actions (e.g., a slide show presentation discussing the~     importance and relevance of measuring pain every shift). Half of the participating intensive~     care units will only receive online feedback, while the other half will additionally gain~     access to the integrated toolbox to facilitate planning and executing actions.~   "
49264|NCT02922088|"~     The DuraGraft® Registry is a European registry of patients who have undergone CABG and whose~     vascular grafts have been treated with DuraGraft. All participating sites will be from~     countries in Europe. The DuraGraft Registry will collect pre-CABG, intraoperative and~     post-operative data, major post-CABG cardiovascular adverse events, health economic outcomes~     and patient reported quality of life over a period of 5 years.~   "
49265|NCT02922075|"~     This study evaluates the impact of soft tissue grafts on soft tissue recession following~     immediate implant, provisional and bone graft placement in compromised sockets. One third of~     the patients received a collagen matrix (CM group), another third received a connective~     tissue graft removed from the palate (CTG group) and the final third did not receive any soft~     tissue graft (CTL group).~   "
49266|NCT02922062|"~     The purpose of this study is to determine the effects of palm oil when consumed as either~     part of a low carbohydrate diet or a high carbohydrate diet on blood lipids, cardiovascular~     health and inflammation. The study will help us better understand how the quality of~     saturated fat and the quantity of carbohydrate interact to impact blood lipids and~     cardiovascular health.~   "
49267|NCT02922049|"~     To assess diagnostic accuracy and clinical effectiveness including cost-effectiveness~     analysis of pCLE in patients after finishing the endoscopic treatment of BORN in detecting~     persistent/recurrent IM, recurrent neoplasia and buried glands.~   "
49269|NCT02922023|"~     In this study, investigators will compare chronotherapy to ABPM. Data collected will include~     hypertension drug therapy regimen prior to and during the study, timing of medication~     administration, and dose, along with the patient's office blood pressure values prior to~     study and one month after modification in therapy. This will enable us to explore whether it~     is a practical endeavor to implement ABPM as a routine process for all uncontrolled~     hypertension patients or whether ABPM does not seem to provide considerable value over~     shifting the timing of drug administration.~   "
49270|NCT02922010|"~     The objective of this study is to assess oral health, oral hygiene knowledge, and daily oral~     hygiene practices of women who participated in a randomized controlled trial (2011001) at~     University of Alabama Birmingham during the period 2012-2014. Additional objectives of the~     research include evaluation of possible cultural, biological or other mechanisms for outcomes~     observed in the OHMOM clinical trial, and oral health screening of children born to mothers~     during the study for the purposes of understanding possible multigenerational effects of oral~     hygiene education.~   "
49271|NCT02921997|"~     This is a single center, randomized, partially-blinded, Phase II, small, targeted,~     prospective study in approximately 30 healthy male and non-pregnant female subjects aged 18~     to 49 years old, inclusive, designed to evaluate and compare the immunogenicity between an~     intramuscular monovalent inactivated influenza A/H7N9 virus vaccine given with and without~     AS03 adjuvant, and an intramuscular unadjuvanted monovalent inactivated influenza A/H3N2v~     virus vaccine. The primary objectives include assessing the serum anti-HA~     hemagglutination-inhibition (HAI) response to influenza A, identifying differentially~     expressed genes in human immune cells, and identifying differentially abundant cellular~     proteins in human immune cells.~   "
49272|NCT02921984|"~     The role of postoperative concurrent chemotherapy (CCT) has not been established for salivary~     gland tumors (SGTs). This prospective study was conducted to evaluate the feasibility and~     safety of customized CCT regimens based on the gene targets of SGTs.~   "
49273|NCT02921971|"~     Primary Objective:~      To evaluate, in comparison with placebo, the efficacy of SAR156597 administered~     subcutaneously for 24 weeks on skin fibrosis in patients with dcSSc.~      Secondary Objectives:~        -  To evaluate the efficacy of SAR156597 compared to placebo on physical/functional~          disability in patients with dcSSc.~        -  To evaluate the efficacy of SAR156597 compared to placebo on respiratory function in~          patients with dcSSc.~        -  To evaluate the safety profile of SAR156597 compared to placebo in patients with dcSSc.~        -  To evaluate the potential for immunogenicity (anti-drug antibodies [ADA] response) of~          SAR156597 in patients with dcSSc.~        -  To evaluate the pharmacokinetics (PK) (trough plasma concentrations) of SAR156597~          administered subcutaneously for 24 weeks.~   "
49274|NCT02921958|"~     Data was collected from Parents of children who were receiving occupational therapy services.~     Three assessment tools were used: 1. Life Participation for Parents, 2. Infant Toddler~     Sensory Profile, and 3) Child Behavior Checklist. Data was used to pursue 2 investigations.~        1. Is the Life Participation for Parents responsive to change after intervention?~        2. Are there correlations between child behavior, child sensory processing, and parental~          participation in their own lives while raising a child with special needs.~   "
49275|NCT02921945|"~     In this trial safety and efficacy of SCT800 (B-domain deleted recombinant factor VIII) is~     being evaluated in 50 subjects, 12 to 65 years of age, with moderate to severe Hemophilia A.~     These subjects will receive open label treatment with SCT800 for approximately 6 months for~     on-demand treatment.~   "
49276|NCT02921932|"~     This study aims to study the efficacy of a preoperative bundle of interventions, which~     consists of preoperative physiotherapy, nutritional support and cognitive exercises on~     elderly frail patients undergoing major abdominal surgery, and evaluating their outcomes.~     There will be two arms, intervention and control.~   "
49277|NCT02921919|"~     This is a single-arm, open-label, extended treatment, safety study in patients treated with~     talazoparib in qualifying studies.~   "
49278|NCT02921906|"~     Neonatal diabetes is diagnosed before 6 months of age and causes high blood glucose levels~     due to the pancreas not secreting insulin. Neonatal diabetes can be caused by a change in a~     DNA region called the KCNJ11 gene. KCNJ11 encodes a channel in the pancreas that acts as a~     switch to turn 'on' and 'off' insulin secretion. A change in KCNJ11 results in a faulty~     channel, which keeps insulin secretion 'switched off'. The diabetes can be treated with~     tablets called sulphonylureas that switch the pancreatic channel 'on', allowing it to secrete~     insulin in response to gut hormones called incretins. Previous research has shown that~     patients who switch from insulin to sulphonylureas have better blood glucose control,~     including fewer episodes of hypoglycaemia (glucose dropping too low), and also avoid the need~     for injections. It is thought that serious side effects from sulphonylureas are uncommon in~     KCNJ11 neonatal diabetes. Some patients report low glucose after meals and we think this may~     be because they make too much insulin if they eat a meal with protein but low amounts of~     carbohydrate. The investigators will test this by giving study participants different meals~     and measuring the amount of insulin, glucose and incretin hormone in the blood afterwards.~   "
49279|NCT02921893|"~     This pilot clinical trial studies how well ixazomib citrate, lenalidomide, and dexamethasone~     work in treating patients with polyneuropathy, organomegaly, endocrinopathy, monoclonal~     gammopathy, and skin changes (POEMS) syndrome. Ixazomib citrate may stop the growth of cancer~     cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy,~     such as lenalidomide and dexamethasone, work in different ways to stop the growth of cancer~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Giving ixazomib citrate, lenalidomide, and dexamethasone may work better in~     treating patients with POEMS syndrome.~   "
49280|NCT02921880|"~     The aim of this pilot study is to assess function, independence, frailty and emotional status~     in 30 patients who have been accepted for TAVI. All patients will attend clinic for review at~     4 weeks post implant and at that stage, 15 patients will be randomised to undertake a cardiac~     rehabilitation programme and the remaining 15 patients will receive standard of care. All~     patients will return to clinic at 3 months and 6 months post implant and undertake the~     functional, independence, frailty and emotional testing again.~   "
49282|NCT02921854|"~     In this exploratory study, the investigators will investigate if markers (molecular and~     immunological) of ICD or anti-tumor immunity (exosomal or molecular) can be detected in the~     serum of patients after high-dose radiotherapy alone or concurrent cisplatin-doublet therapy~     and radiotherapy. For each patient: withdraw blood at three times during treatment for~     analysis.~   "
49283|NCT02921841|"~     Teenagers in mental health treatment are at greater risk for HIV and other sexually~     transmitted infections. This greater risk comes from many factors, some of which are related~     to poor emotion regulation and low self-confidence. There is a need for an HIV prevention~     program specifically for these at-risk teens. The goal of this study is to develop a~     computerized HIV prevention study tailored to adolescents in mental health treatment. The~     first part of the study will develop core sessions of D*STAR. It will do this by using focus~     group feedback from approximately 15 adolescents in mental health treatment, and~     approximately 10 parents of youth in mental health treatment and mental health treatment~     center staff. Feedback on D*STAR prototype sessions will also be collected from two~     individual interviews with approximately 15 youth in mental health treatment. Core sessions~     will then be reviewed in an open trial with approximately 30 adolescents.~      The second part of the study will develop and refine digital versions of the remaining~     sessions of STAR and a digital general health promotion intervention. It will do this by~     using focus group feedback from approximately 20 adolescents in mental health treatment, and~     approximately 10 community advisory board members which include variety of staff from mental~     health treatment settings such as administrators, supervisors, therapists, health teachers at~     therapeutic schools, clinicians at day hospitals and day treatment programs, parents of youth~     in mental health treatment and from relevant community organizations, such as those serving~     lesbian, gay, bisexual, transgender, and questioning youth. Feedback on D*STAR prototype~     sessions will also be collected from two individual interviews with approximately 20 youth in~     mental health treatment. All developed sessions (from both Phase I and Phase II) will then be~     reviewed in an open trial with approximately 20 adolescents. A randomized control trial (RCT)~     will then be conducted to compare D*STAR to a time matched digital general health promotion~     intervention among approximately 120 adolescents. For the pilot and RCT phases, assessments~     will be administered prior to randomization, immediately following the last intervention~     session, and at one month post-intervention (pilot study) or at three month post-intervention~     (RCT).~   "
49284|NCT02921828|"~     1. Planned enrollment period One year (The planned number of patients to be enrolled is set~          to 400 patients.) Since all patients who are prescribed with Pomalyst are registered in~          RevMate®, enrollment using the Registration Form of the surveillance will be completed~          at the time when the planned number of patients to be enrolled is reached. During a~          period until conditions for approval are removed, a system enabling to retrospectively~          collect appropriate information based on patient data from RevMate® will be, as~          necessary, maintained.~        2. Planned duration of the surveillance Anticipated to be 2 years and 6 months from the~          start date of release of Pomalyst~   "
49285|NCT02921815|"~     To analyze the occurrence of transformation from myelodysplastic syndrome (MDS) to acute~     myeloid leukemia (hereinafter referred to as transformation from MDS to AML) in patients with~     myelodysplastic syndrome with a deletion 5q cytogenetic abnormality (hereinafter referred to~     as del(5q)MDS) who received Revlimid® 5 mg Capsules (hereinafter referred to as Revlimid) and~     who are continuing or no longer continuing Revlimid treatment.~        1. Planned registration period This period started on the date of initial marketing of~          Revlimid and will end on the day when the appropriateness of enrollment is assessed for~          all del(5qMDS) patients in the all-case surveillance.~        2. Planned surveillance period This period started on the date of initial marketing of~          Revlimid and will end 3 years after the last enrolled patient begins receiving Revlimid.~   "
49286|NCT02921802|"~     To understand the safety and efficacy of Revlimid® 5 mg Capsules (hereinafter referred to as~     Revlimid) in all patients who are treated with it under the actual condition of use pursuant~     to the conditions of approval.~        1. Planned registration period This period started on the date of initial marketing of~          Revlimid and will end at the time when the planned number of patients to be enrolled is~          reached.~        2. Planned surveillance period This period started on the date of initial marketing of~          Revlimid and will end on the day when the approval condition related to all-case~          surveillance is terminated.~   "
49287|NCT02921789|"~     The purpose of this study is to assess the efficacy of the bleselumab regimen (basiliximab~     induction, tacrolimus, steroids and bleselumab) compared with the Standard of Care (SOC)~     regimen (basiliximab induction, tacrolimus, steroids and mycophenolate mofetil [MMF]) in the~     prevention of recurrent Focal Segmental Glomerulosclerosis (rFSGS) defined as nephrotic range~     proteinuria with protein-creatinine ratio (≥ 3.0 g/g) through 3 months post-transplant.~     Death, graft loss or lost to follow-up will be imputed as rFSGS.~   "
49288|NCT02921776|"~     This Phase II Small Business Technology Transfer Research (STTR) will deliver a comprehensive~     patient communication solution for communication-impaired patients in the intensive care unit~     that may help decrease days in delirium, decrease anxiety levels, and reduce sedation~     exposure which are proximal outcomes known to be associated with decreased mechanical~     ventilation days, shorter lengths of ICU and hospital stay, and lower healthcare cost. The~     primary goal of this Phase II STTR proposal is to further define user requirements and~     product specifications and develop a prototype of VidaTalk, a patient-centric, touch pad~     communication software, to provide mechanically ventilated (MV) patients an evidence-based~     solution for effectively communicating their needs to care providers and family. A secondary~     goal is to test the impact of the VidaTalk on clinical outcomes. This study will use mixed~     methods including observations and interaction with hospitalized patients as they use the~     VidaTalk tool, surveys and medical record data extraction, product evaluation and brief~     interview, satisfaction surveys with family members of ICU patients, and focus groups with~     Registered Nurses.~      Specific Aim 1. Develop a commercial prototype of VidaTalk that will include multilingual and~     customizable messages, compatibility with tablet devices, picture symbols, and integration~     with mobile communication devices.~      Specific Aim 2. Demonstrate usability with iterative user assessment testing in a clinical~     setting.~      Specific Aim 3. Test the clinical efficacy of VidaTalk via android application with MV~     patients by examining qualitative and quantitative endpoints in a clinical setting. Aim 3~     hypothesis: MV patients using VidaTalk will demonstrate significant reductions in~     patient-reported communication difficulty and frustration, anxiety, sedation exposure,~     delirium/coma-free days, and improved patient and family satisfaction with ICU care compared~     to MV patients receiving attention-control (i.e., tablets with health education application).~      Specific Aim 4. Validation of electronic visual analogue scale, verses current standard paper~     scale.~      Specific Aim 5 a, b and c. Test the effect of the communication tablet (VidaTalk) on~     psychological symptoms in family caregivers.~   "
49289|NCT02921763|"~     This survey is intended to collect efficacy and safety data of Duphaston® Tablets in patients~     with endometriosis under actual condition of its use and to obtain data for effectively and~     safely utilizing this drug.~   "
49290|NCT02921750|"~     The investigation is designed as an open, randomized, non-inferiority, multi-centre~     investigation.~      212 evaluable subjects will be randomised. Subjects to be included will suffer from an~     exuding venous or mixed ulcer of predominantly venous origin. Subjects will either be~     randomized to Exufiber® or Aquacel® Extra using centralized randomization~   "
49291|NCT02921737|"~     This is an open-label, non-randomized, sequentially enrolling single arm phase II trial to~     evaluate the activity of TAS-102 in previously treated metastatic and locally advanced~     unresectable pancreatic cancer after progression through or intolerance to first line~     chemotherapy. Trial therapy will consist of TAS-102 (Lonsurf®) 35 mg/m2 to be given orally~     twice daily on days 1-5 and 8-12 with cycles repeating every 28 days. The primary endpoint is~     to determine the progression free survival (PFS) in subjects with unresectable pancreatic~     adenocarcinoma.~   "
49292|NCT02921724|"~     This is a prospective testing-validation, interventional, non-pharmacological study on a new~     app for oral anticancer therapy management.~      A total of 80 patients will be considered: 20 evaluable patients in the training step; 60~     patients in the validation step. In the training step will be considered evaluable the~     patients with: at least 6 weeks of treatment; visit at 6 weeks after the start of treatment~     performed and questionnaires self-administered.~      Patients will be visited every 6 weeks. In the training step, patients will remain under~     observation for a minimum of 6 weeks, until change of therapy (due to progression of disease,~     unacceptable toxicity, death, discontinuation) or for a maximum of 12 weeks. Patients~     enrolled in the validation step will remain under observation until change of therapy (due to~     progression of disease, unacceptable toxicity, death, discontinuation) or for a maximum of 24~     weeks.~      The objective of this study is to assess the capability of a newly developed interactive~     health care application to support patients and health professionals in the shared management~     of oral anticancer therapies, improving adherence, preventing complications at home,~     toxicities, improper treatment reductions or interruptions, emergency accesses and to assess~     the system usability and acceptability by patients and health professionals, integration in~     the hospital workflow, monitoring over time patient perceived levels of quality of care,~     quality of life, social support, anxiety, and self-care capability.~   "
49293|NCT02921711|"~     A prospective, multicenter, observational assessment of the safety and effectiveness of the~     LVIS® device in the treatment of wide necked intracranial aneurysms.~   "
49294|NCT02921698|"~     A prospective, multicenter, observational evaluation of the safety and efficacy of the FRED®~     device in the treatment of intracranial aneurysms.~   "
49295|NCT02921685|"~     This study will determine the Maximal Tolerated Dose if any and the recommended dose for~     phase 2 of monalizumab, a monoclonal antibody directed against the CD94/NKG2A receptor, after~     allogenic stem cell transplantation. All patients will receive one single intravenous~     administration of one of the four doses of monalizumab.~   "
49296|NCT02921672|"~     By doing this study, researchers hope to learn if older adults with and without cognitive~     impairment can adhere to a Mediterranean diet.~   "
49297|NCT02921659|"~     The purpose of this study is to assess the efficacy of supplementation with the Nicotinamide~     Adenine Dinucleotide (NAD+) precursor compound, Nicotinamide Riboside (NR), for improving~     physiological function (vascular, motor, and cognitive) in healthy middle-aged and older~     adults.~   "
49298|NCT02921646|"~     The purpose of this study is to determine whether evolution of resting energetic expenditure~     is a predictive marker of tumoral response for patients suffering from metastatic pancreatic~     cancer and treated with 1st line of chemotherapy.~   "
49299|NCT02921633|"~     This study will investigate whether behaviourally informed changes to the invitation process~     can improve uptake of childhood influenza vaccine by two and three year olds at primary care.~   "
49300|NCT02921620|"~     The study will be a randomized, double blind, placebo-controlled study of the safety and~     efficacy of PRX-102 in ERT naïve male patients randomized 1:1. Patient age will be 14 to 45~     years. Patients must have diarrhea defined as ≥ 3 stools a day with an average consistency of~     ≥ 5.5 on the Bristol Stool Form Scale (BSFS) by patient electronic diary and moderate to~     severe gastrointestinal symptoms as defined by the Irritable Bowel Symptom Severity Score~     (IBSSS) Part 1 average > 175 derived from at least two IBSSS assessments during screening~     period. Patients will receive intravenous infusions of PRX-102 1 mg/kg or placebo every two~     weeks for 6 months.~   "
49301|NCT02921607|"~     The goal is to define a set of clinical pathways for heart failure patients, reflecting the~     period from prior to admission to the post-discharge period following hospitalisation, under~     the current system that exists at the two clinical sites [as mentioned previously, the main~     site is at St Vincent's University Hospital in Dublin, but to ensure generalizability the~     project team will also carry out similar work Portsmouth Hospital, United Kingdom]. These~     pathways have been drawn up using the experience of the clinical investigators, using an~     interactive workshop approach and a pilot study.~        1. Pre-Admission Pathway~        2. Emergency Department Pathway~        3. In-Hospital management Pathway~        4. Pre-discharge Pathway~        5. Post-Discharge Pathway~      During identification of these pathways, the research team identified the settings/personnel~     that require study to more fully comprehend the methods, strengths and weaknesses of the~     present processes. Study activities are focused on two aspects of the patient journey,~     immediately before discharge and three months post discharge during the outpatient phase.~   "
49302|NCT02921594|"~     Primary: The primary objective of this pilot study is to compare the intraarticular~     kinematics by fluoroscopy of Vanguard XP to that of Vanguard CR.~      Secondary: The secondary objective of this pilot study is to compare the standing balance by~     force plate of patients with the Vanguard XP prosthesis to those who have Vanguard CR~     prosthesis. Furthermore, we wish to assess isometric quadriceps muscle strength in both~     groups.~   "
49303|NCT02921581|"~     Dose-painting may increase the chance of cure at minimised radiation-induced toxicity in~     intensity-modulated radiotherapy (IMRT) for primary head and neck cancer. This could also~     apply for recurrent and second primary head and neck cancers in previously irradiated~     volumes. This trial (RIDPAINT) investigates the feasibility of FDG-PET guided radiotherapy~     using IMRT dose-painting by contours for patients with recurrent and second primary head and~     neck cancer.~   "
49304|NCT02921568|"~     This study is designed to evaluate and compare in-tissue performance of OCT scans on the new~     Optos P200TE, versus the predicate Optos Spectral OCT/SLO device.~   "
49305|NCT02921555|"~     The purpose of this study is to determine the efficacy of high-dose corticosteroid pulses~     added to conventional oral corticosteroid course for moderate flares of ulcerative colitis.~   "
49306|NCT02921542|"~     To evaluate vessel lumen quality (gain) and patient outcomes based on treatment with a~     predetermined laser treatment protocol in patients presenting with varying lesion types or~     morphologies: homogenous (plaques with a uniform texture-smooth and regular), heterogeneous~     (plaques with non-uniform texture-smooth and irregular surface), calcific (consisting of~     calcium) and restenotic (reoccurring narrowing of the vessel following prior treatment)~     associated with peripheral arterial disease (PAD).~   "
49307|NCT02921529|"~     The purpose of this study is to observe the effects of transcutaneous electrical acupoint~     stimulation(TEAS) on postoperative recovery after colon surgery.~   "
49308|NCT02921516|"~     Despite overall declines in HIV incidence and mortality since ART scale-up in low and middle~     income countries, both have risen among youth. In addition, HIV-infected youth achieve~     inferior treatment outcomes compared to their adult counterparts in both high- and low-income~     countries, and these poorer outcomes are generally attributed to suboptimal adherence. Thus,~     there is a critical need for the development of adherence and risk reduction interventions~     for the growing cohort of these youth, and the proposed cognitive behavioral N'ap Grandi is~     one such intervention.~   "
49309|NCT02921503|"~     The study aims to evaluate the effectiveness of a mobile application to assist in the~     prescription of topical corticosteroids (TCS), focusing on best fit choices of potency,~     vehicle and volume. The mobile application will be developed from the results obtained in a~     systematic literature review and quality assessment of clinical practice guidelines for~     topical corticosteroid use. The quality of the guidelines will be assessed using the AGREE II~     tool. After the app user enters in information concerning patients' rash location and desired~     treatment duration, the app will generate a list of recommended topical steroids (focusing on~     specific quantity and potency) for the patient's particular area of need. The objective of~     the study is to evaluate whether the use of a standardized application will change~     prescribing practices for primary care physicians, physician assistants and nurse~     practitioners.~   "
49310|NCT02921490|"~     Chronic pain incurs over half a trillion dollars in lost productivity (healthcare, lost~     wages, etc) annually. The most common source is low back pain (LBP), often from facet joints.~     The clinical evaluation of facet joints is challenging and anatomic imaging findings of facet~     joint; degenerative change; correlate poorly with pain. Therefore, it is difficult to select~     appropriate candidate patients/facet joints to treat. Misguided percutaneous treatment can~     cost thousands of dollars per session and delay diagnoses. Very limited retrospective~     information suggests that high grade peri-facet MRI signal change correlates to the side of~     LBP. However, this has not fully characterized the imaging findings and has not correlated to~     expert clinical exam/percutaneous response, precluding robust and meaningful clinical impact.~     Minimal retrospective data concludes inflammatory changes can be identified on FDG-PET exams,~     but the evidence of correlation to patient pain is lacking. Limited DWI exists for~     inflammatory spondyloarthropathies and myopathies, but is also lacking.~      This is an exploratory study investigating the utility of FDG PET activity and MRI signal~     change around facet joints in the clinical management of low back pain. This study will help~     determine if such imaging biomarkers could change clinical management. Additionally, this~     will provide data that will be vital to planning a larger prospective study evaluating the~     ability of imaging biomarkers to predict response to comparison medial branch blocks and RF~     ablation for treatment of facet joint pain.~   "
49311|NCT02921477|"~     The present study is designed as an open label study of patients with mild cognitive~     impairment or dementia to evaluate longer term tolerability and potential efficacy of~     tyrosine kinase inhibitors. Baseline and outcome measures in this study utilize validated~     tests that are appropriate for repeated measures which are not affected by practice effects.~     Advantages of this study include the fact that the neuropsychological testing instruments and~     advanced MRI imaging protocols that have been in routine clinical deployment provide for a~     high degree of availability and reliability for diagnosis and for monitoring change of~     status. Quality assurance is tightly controlled. The study population is sufficiently broad~     and the conditions of interest are sufficiently prevalent so that recruitment of the~     projected numbers of subjects is not a limiting factor.~      For a Phase I trial there is a proposed 20 patient sample to determine the frequency of~     common side effects in the population that is being studied. Subjects will be administered~     the initial dose of bosutinib, with dosage progressively increased over the course of the~     study. The initial dose of bosutinib is 100 mg tablet, once per day. The dose will be~     increased as tolerated up to 300 mg per day.~      All subjects will be started at 100 mg/day and the dose will be increased by 100 mg each~     month if the lower dose is tolerated without significant side effects. That is to say, the~     subject will take 100 mg/day every day for the first month, 200 mg/day every day for the~     second month, and 300 mg/day every day for the third month and for the remainder of the~     study, provided that adverse reactions do not prohibit continuation at this dosage. The~     investigators will be using the Common Terminology Criteria for Adverse Events (CTCAE)~     Version 4.0 to monitor, evaluate, and report adverse reactions on an ongoing basis. Stopping~     and dose reduction rules for reported adverse reactions have been taken from the package~     insert of bosutinib.~   "
49312|NCT02921464|"~     Florida Cardiovascular Quality Network Application of Clinical Decision Support Software~     Tools at the Point of Care in Patients with Stable Ischemic Heart Disease - a Quality~     Outcomes Registry~   "
49313|NCT02921451|"~     The purpose of this study is to determine the long term performance of Restorelle system for~     the treatment of uterine prolapse.~   "
49314|NCT02921438|"~     The study is a prospective multi-centre observational study to evaluate a portable~     magnetocardiograph device for the rule-out of acute coronary syndrome (ACS) in patients who~     present to the emergency department with chest pain and other symptoms consistent with ACS.~   "
49315|NCT02921425|"~     This study was a pilot 3-month clinical trial that investigated the feasibility,~     effectiveness, and acceptability of using the Track Health function of the Veterans Health~     Administration's patient health record for effecting a more positive physical activity (PA)~     and dietary intake lifestyle in a sample of 38 overweight and obese Veterans with~     prediabetes. Baseline and three-month post-intervention outcomes were measured in two main~     domains: objective (e.g., weight) and subjective (e.g., self-efficacy).~   "
49316|NCT02921412|"~     This is a prospective, multi-center, subject-masked, bilateral, daily wear, two-month~     dispensing study~   "
49317|NCT02921399|"~     After endoscopic resection (ER) of gastric tumors, eradication of Helicobacter pylori (H.~     pylori) infection is advised to reduce metachronous recurrence. However, few studies have~     addressed factors influencing H. pylori eradication rates in the aftermath of ER, and none~     have focused on the optimal timing of therapy to eradicate H. pylori post-ER.Therefore, the~     investigators will conduct to evaluate whether differences in timing of eradication therapy~     after ER of gastric tumors.~   "
49318|NCT02921386|"~     A Phase 2, open-label, randomized, cross-over, pharmacokinetic study designed to determine~     the effect of meals of various amounts of fat given immediately prior to dosing on the~     pharmacokinetics of oral testosterone undecanoate. Approximately 20 hypogonadal subjects will~     be dosed for a 14 day run-in period. This will be followed by a randomized sequence of five~     periods over a 6 day confinement period. Subjects will receive a randomly ordered sequence of~     breakfast meals containing various amounts of fat, fasting, 15 g, 30 g, 45 g and a high fat~     breakfast consistent Guidance for Industry on Food-Effect Bioavailability and Fed~     Bioequivalence Studies.~   "
49319|NCT02921373|"~     Cell-based therapies in the form of stem cell-based or immune cell-based therapies are~     becoming important treatment options that are either approved for clinical use or are showing~     promise in clinical trials. One of the issues regarding cell-based therapies is that, once~     the cells are injected into a subject, there is no easy way to track where they go, assess~     whether adequate numbers of cells arrive at the intended therapeutic target and for how long~     they persist at a given location. To address this issue non-invasive imaging methods have~     been developed using magnetic resonance imaging (MRI). When used with an appropriate cell~     labelling contrast agent, Cellular MRI can track cells non-invasively in vivo. Detection of~     cells is accomplished with an inert imaging agent containing the MRI sensitive fluorine-19~     (19F) nuclei. The objective of this study is to demonstrate that 19F-MRI is safe to use in~     humans so that it can subsequently be used to track cell-based immunotherapies in future~     clinical trials. The long term goal is to be able to quantify immune cell migration to~     secondary lymphoid tissues and potentially to tumors and correlate to therapeutic outcomes.~   "
49320|NCT02921360|"~     The aim of this study is to determine whether early administration of aspirin in acute~     ischemic stroke patients treated with systemic thrombolysis is safe and can improve outcomes~     due to decreasing the number of early rethromboses.~   "
49321|NCT02921347|"~     The aim of this study is to facilitate weaning by switching between invasive and noninvasive~     ventilation in difficult-weaning patients.~   "
49322|NCT02921334|"~     The aim of this study is early tracheotomy to facilitate weaning by switching between~     invasive and noninvasive ventilation.~   "
49323|NCT02921321|"~     Muscular Dystrophy can affect the skeletal muscles and also the heart and breathing muscles,~     causing significant morbidity and mortality. As patients are now living longer, treatment of~     muscular dystrophies involves drugs that help improve heart function. However, better types~     of heart imaging studies are needed to understand how these treatments work. Researchers want~     to improve heart imaging to identify earlier indicators of heart dysfunction in muscular~     dystrophy patients and how these are changed by medical treatment. The new imaging indicators~     will also help identify candidates for entry into future clinical trials.~   "
49324|NCT02921308|"~     Health Issue: Bronchopulmonary dysplasia (BPD), a chronic lung disease, is the most common~     complication of being born premature. Damage to the still developing lung stops the normal~     formation of the alveoli. Young adults with a history of BPD have lower lung function, early~     heart disease, and increased risk of death, compared to those without BPD. Recently, it has~     been reported that they may also develop a type of lung disease typically seen in older~     adults with a longstanding history of smoking. The severity of lung disease is usually~     measured using pulmonary function tests (PFT), but these tests may be normal, even in the~     presence of important changes in the fine structure of the lung. Such structural changes may~     be early markers of future lung disease and can be detected using lung magnetic resonance~     imaging (MRI). Unlike other ways of imaging the lungs, MRI does not expose people to harmful~     X-rays. To date, no studies have been done to examine the fine structure of the lung of~     school-aged children who had a history of BPD, to determine whether there are signs of lung~     disease that might not otherwise be obvious. This is important because once armed with this~     information, preventive measures can be taken to avoid worsening of lung disease.~      Objective: 1) In 7-9 year-old children born extremely premature, lung MRI will be compared~     between those with and without BPD. The Investigators expect to observe more severe~     structural lung abnormalities in children with BPD, compared to those without BPD; 2) The~     Investigators will test to see if children with more severe MRI abnormalities also have worse~     lung function, and/or more symptoms of breathing problems. The Investigators expect to~     observe more PFT abnormalities in children with BPD than in those without and that these will~     match up with lung fine structure abnormalities identified on MRI.~      How will work be undertaken? Children 7-9 years old who were born extremely prematurely will~     be recruited to participate in this study. Participants will be identified from Neonatal~     Follow-up clinics they attended. The Investigators will enroll 20 children with BPD and 20~     without BPD. Participants will have lung MR images taken, during which they need to lie still~     for a few minutes. PFT will also be performed, during which they will blow into a machine.~     Parents will be asked to complete questionnaires about breathing problems, their living~     conditions (environment) and any doctor visits or hospital stays. Medical charts will be~     reviewed for information about their birth.~      Unique/Innovative Aspects: This will be the first study using MRI as an innovative way to~     visualize and measure fine structure of the lung in children born prematurely with and~     without BPD. These findings may be early markers of lung disease, which would identify~     children who have, or are at risk of developing lung disease later in life, for whom the~     Investigators may be able to offer treatments now and/or prevent worsening of lung disease.~   "
49325|NCT02921295|"~     The purpose of this study is to compare the College Park Sidekicks to conventional stubby~     prosthetics to investigate their effects on bilateral above-knee-amputee gait velocity,~     exertion, and balance. The investigators aim to demonstrate that: (i) greater balance will be~     observed and reported on a level and gravel surface with the Sidekicks; (ii) time to complete~     the 10-meter walk test will be decreased wearing Sidekicks compared to the conventional~     stubby prosthesis; and (iii) subjects will report feeling less exerted with the sidekicks.~   "
49326|NCT02921282|"~     In this study, potential associations between several genetic polymorphisms and nicotine~     dependence will be examined. The relative reinforcing efficacy of cigarettes using the~     forced-choice procedure will be assessed. In addition, reactivity to smoking cues using a~     reliable procedure will be conducted.~   "
49327|NCT02921269|"~     This phase II trial studies how well atezolizumab and bevacizumab work in treating patients~     with cervical cancer that has come back, remains despite treatment, or has spread to other~     places in the body. Monoclonal antibodies, such as atezolizumab and bevacizumab, may shrink~     tumor cell and interfere with the ability of tumor cells to grow and spread.~   "
49328|NCT02921256|"~     This randomized phase II trial studies how well veliparib works with combination chemotherapy~     and radiation therapy in treating patients with rectal cancer that has spread from where it~     started to nearby tissue or lymph nodes (locally advanced). Veliparib may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as modified (m)FOLFOX6 regimen, work in different ways to stop the growth~     of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink~     tumors. Giving veliparib with combination chemotherapy and radiation therapy may kill more~     tumor cells and giving it before surgery may make the tumor smaller and reduce the amount of~     normal tissue that needs to be removed.~   "
49343|NCT02921061|"~     This phase I/II trial studies the side effects and best dose of decitabine when given~     together with filgrastim, cladribine, cytarabine, and mitoxantrone hydrochloride in treating~     patients with acute myeloid leukemia or myelodysplastic syndrome that is newly diagnosed, has~     come back or has not responded to treatment. Drugs used in chemotherapy, such as decitabine,~     cladribine, cytarabine, and mitoxantrone hydrochloride work in different ways to stop the~     growth of cancer cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Colony-stimulating factors, such as filgrastim, may increase~     the production of blood cells and may help the immune system recover from the side effects of~     chemotherapy. Decitabine, filgrastim, cladribine, cytarabine, and mitoxantrone hydrochloride~     may work better in treating patients with acute myeloid leukemia and myelodysplastic~     syndrome.~   "
49329|NCT02921243|"~     In a sample of 20 inpatients with a DSM-IV-TR/DSM 5 diagnosis of schizophrenia or~     schizoaffective disorder, investigators propose to conduct a prospective, 2 week~     observational trial to collect gastrointestinal stool samples in order to characterize the~     microbiota in people with schizophrenia and examine its variability over time. Participants~     may elect to participate for an additional two weeks, during which they will receive the~     prebiotic, oligofructose-enriched inulin (FOS), in order to examine its effects on the~     relative preponderance of butyrate-producing bacteria in the gut microbiome. Investigators~     will use an inpatient sample in order to standardize meals, exercise and environmental~     mediators. This is considered a feasibility, pilot study in order to apply for future grant~     funding. Investigators will recruit patients from the Treatment Research Program inpatient~     unit, Maryland Psychiatric Research Center, University of Maryland School of Medicine.~   "
49330|NCT02921230|"~     The EMINENT study is a prospective, multi-center study confirming the superior effectiveness~     of the ELUVIA stent versus Self-Expanding Bare Nitinol Stents in the treatment of lesions in~     the femoropopliteal arteries.~   "
49331|NCT02921217|"~     The study's main objective is to investigate if an extract containing the probiotic~     Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145) has a positive effect on the~     accumulation of abdominal visceral fat in people with abdominal obesity.~   "
49332|NCT02921204|"~     Vitamin D deficiency is most diagnosed among women living in the Kingdom of Saudi Arabia.~     Many factors have been attributed to the incidence of vitamin D deficiency. Saudi women are~     thought to be at greater risk for vitamin D deficiency because of their darker skin type and~     the likelihood of reduced ultraviolet exposure . The present study entitled, Dietary Intake~     and Vitamin D Level in adult Women, was formulated as there is paucity of data on the~     etiologic importance of dietary intake in Vitamin D level on blood on women. The major~     objective of the proposed study is to assess the effect of dietary intake of nutrients and~     level of vitamin D in women .~   "
49333|NCT02921191|"~     Purpose:~      With the existing recombinant human granulocyte colony-stimulating factors (G-CSFs) patents~     expiring and the FDA approval of new biosimilar and innovator biologics, patients being~     treated with Grade III and IV myelosuppressive chemotherapy regimens will have additional~     therapeutic options. This observational study will describe the patient characteristics of~     new users of G-CSFs. It will describe in the treatment cohorts a primary outcome of~     hospitalizations for febrile neutropenia. The BBCIC will use the findings from this~     descriptive analysis to design a comparative study evaluating the real-world effectiveness~     and safety of biosimilar and innovator G-CSFs.~   "
49334|NCT02921178|"~     The purpose of this study is effects of Omalizumab compared to non-Omalizumab treatment in~     the propensity-matched group on asthma exacerbation in asthma patients in Korea: a~     retrospective cohort in real world.~      Omalizumab was approved 2007 in Korea and has been used in this center. We would like to~     collect and analyze the data and exacerbation outcomes of these patients on Omalizumab; no~     Korean real world data available.~   "
49335|NCT02921165|"~     The aim of this study is to determine the beneficial effect of mouth rinses, both topical~     analgesic and saline regimens as an adjuvant therapy in the presence of standard prescription~     of post-operative pain killers on the progress of socket healing following routine dental~     extraction.~   "
49336|NCT02921152|"~     Operable early stage breast cancer patients staged according to NCCN guidelines are subjected~     to bone marrow aspiration/trephine biopsy at the time of the definitive operation under~     general anesthesia. The specimen will be fixated in neutral tamponaded formalin and the~     sections will be examined by H&E and cytokeratin immunohistochemically. If disseminated tumor~     cells are identified ER (estrogen receptor), PR (progesterone receptor), HER2/neu will be~     studied. Disseminated tumor cells will be recorded quantitively and semiquantitatively.~     Results of the pilot study will be evaluated as observational study.~   "
49337|NCT02921139|"~     Till now, trans-arterial chemoembolization (TACE) is still one of the common modalities in~     treating hepatocellular carcinoma patients with unresectable intermediate stage. However,~     residual viable HCC after TACE is not uncommon, leading to a poor overall survival after TACE~     alone. Recently, stereotactic ablative radiotherapy (SABR) has been reported to be~     potentially useful for curatively managing early-stage HCC in retrospective studies. Thus,~     conducting a randomized clinical trial to test the role of SABR in eradicating post-TACE~     residual tumors is therefore encouraged. The present phase-III trial intended to compare~     clinical outcomes between TACE + SABR and TACE + re-TACE for HCC patients with~     post-prior-TACE residual tumors.~   "
49338|NCT02921126|"~     To quantify rates of bleeding events and investigate the characteristics of prescribed~     patients, rates of bleeding events, persistence and healthcare resource utilization of Oral~     Anticoagulants (OACs) prescribed in routine clinical practice.~   "
49339|NCT02921113|"~     Acute Kidney Injury(AKI) is of the serious complications in patients with undergoing on-pump~     cardiac surgery. End stage kidney failure requiring dialysis therapy after cardiac surgery is~     associated with more than 60% mortality rate. Involvement of AKI after on-pump cardiac~     surgery increases the mortality rate 19 times. suPAR is one of the novel biomarker which has~     potential prognostic value for renal dysfunction in patients with undergoing on-pump cardiac~     surgery. Early diagnosis and prompt intervention to prevent AKI has great importance for~     management of postoperative cardiac patients.~   "
49340|NCT02921100|"~     150 patients who had suspected pancreatic malignancy were planed to be enrolled in this~     study. Equal cytological samples of each patient undergoing EUS-FNA were examined by digital~     image analysis and conventional cytology respectively. The investigators aim to compare the~     efficacy of DIA and conventional cytology in diagnosing pancreatic cancer. Further more, the~     investigators also collected the blood sample of each enrolled patient for advanced study.~   "
49341|NCT02921087|"~     This study seeks to address whether or not different types of daily disposable soft contact~     lenses may be a beneficial option for patients complaining of eye strain and visual~     discomfort while using digital devices.~   "
49342|NCT02921074|"~     This study is a validation study to document the acceptability of the Tonic and Phasic~     Alertness Training (TAPAT) training program in older adults with chronic late-life insomnia.~     The goal of this study is to employ a computerized attention-training program, TAPAT,~     designed for chronic late-life insomnia in a randomized, controlled trial to assess~     feasibility and initial efficacy in this population.~   "
49344|NCT02921048|"~     This observational study recruits healthy individuals who have been routinely taking high~     amount (at least 3 g/wk) of dietary eicosapentaenoic acid (EPA) and docosahexaenoic acid~     (DHA), and those who don't, and examines the efficacy of dietary EPA and DHA in ameliorating~     the cardiopulmonary effects of exposure to ambient air pollution.~   "
49345|NCT02921035|"~     This is an open label, non randomized, uncontrolled, multicenter, single arm observational~     study. In this study, the enrolled subjects will be treated with Rebif human serum albumin~     (HSA)-free formulation (with or without RebiSmart) 44 microgram (mcg), subcutaneous (sc),~     thrice in a week (tiw) for 24 months.~   "
49346|NCT02921022|"~     The purpose of this study is to test any good and bad effects of the study drug called~     PEGPH20. PEGPH20 alone is considered investigational. The Food and Drug Administration (FDA)~     has not approved the marketing or sale of PEGPH20, but have authorized its use in research~     studies with humans. PEGPH20 could shrink the cancer but it also can cause side effects.~     PEGPH20 is an enzyme that breaks down a specific tissue component called hyaluronan produced~     by some tumors. Pancreatic tumors often have a large amount of hyaluronan. The removal of~     hyaluronan from tumors may decrease tumor growth.~   "
49347|NCT02921009|"~     This study will investigate the effectiveness in treating keratoconus, pellucid marginal~     degeneration and post LASIK iatrogenic ectasia utilizing fluence rates and treatment times of~     Corneal Cross Linking other than the original FDA approved protocol of 3mw/cm2.~   "
49348|NCT02920996|"~     This research study is examining merestinib (a targeted therapy) as a possible treatment for~     non-small cell lung cancer (NSCLC) that was found to have a specific change in the MET gene~     (a MET exon 14 mutation); or as a treatment for solid tumors that have an alteration in the~     NTRK gene (an NTRK1, 2, or 3 rearrangement).~   "
49349|NCT02920983|"~     This study aims to compare the clinical performance of the somfilcon A, nelfilcon A II 2 and~     omafilcon A II 2 daily disposable contact lenses.~   "
49350|NCT02920970|"~     This study aims to compare the clinical performance and subjective acceptance of the~     narafilcon A lens with the stenfilcon A lens when used on a daily wear, daily disposable~     basis.~   "
49351|NCT02920957|"~     The aim of this study is to determine the clinical performance of comfilcon A in comparison~     to senofilcon C.~   "
49352|NCT02920944|"~     This study aims to examine technical feasibility and diagnostic yield of new 20-gauge Procore~     needle for EUS-guided fine needle biopsy in solid lesions by comparing with 22-gauge Procore~     needle. The study design is prospective, randomized study.~   "
49353|NCT02920931|"~     A Randomized, Open-label, Single-dosing, 2X2 Crossover Study to Compare the Safety and~     Pharmacokinetics of BR-TND Tablet(Tenofovir Disoproxil) With Viread Tablet(Tenofovir~     Disoproxil Fumarate) in Healthy Male Volunteers.~   "
49354|NCT02920918|"~     Investigator Initiated Study to study the effects of Canagliflozin 100 milligrams (mg) vs~     Sitagliptin 100 mg on parameters of aerobic exercise capacity (peak oxygen consumption [VO2])~     and ventilator efficiency (minute ventilation [VE]/carbon dioxide production [VCO2] slope) at~     cardiopulmonary exercise test (CPET) after 12 weeks of active treatment (primary endpoints).~     Blood pressure (BP), body water content, body composition, cardiac function, and diet will be~     also measured (secondary endpoints).~   "
49355|NCT02920905|"~     The present clinical study will be undertaken to compare study between the effect of~     atracurium with lidocaine versus addition of magnesium sulphate to the same doses with~     lidocaine administrated alone in IntraVenous Regional Anaesthesia to access motor block,~     sensory block, tourniquet pain and post operative analgesia .Also assessment of patient and~     surgeon satisfaction .~   "
49356|NCT02920892|"~     The overall goals are to change the paradigm for development of mechanism targeted~     pharmacotherapy in neurodevelopmental disorders and provide a definitive test of the mGluR~     theory in humans by determining whether AFQ056, an mGluR5 negative modulator, can enhance~     neural plasticity in the form of language learning during an intensive language intervention~     in very young children with fragile X syndrome. This trial therefore will use an innovative~     but exploratory new trial design to develop a different way to examine efficacy of an agent~     with substantial support as a drug targeting CNS plasticity in preclinical models of a~     developmental disorder. If the design is successful, this trial can serve as a model for~     future trials of mechanistically-targeted treatments operating on neural plasticity in other~     neurodevelopmental disorders.~   "
49357|NCT02920879|"~     This study investigates airway effects of PEEP during maskventilation at anesthesia~     induction. Four patient groups will be ventilated with different PEEP and driving pressures~     to evaluate time to open airway after start of positive pressure maskventilation during~     anesthesia induction.~   "
49358|NCT02920866|"~     This study plans to learn more about the effects of physical therapy (PT) following a total~     hip arthroplasty (THA). The purpose of this study is to compare standard of care PT after THA~     with a physical therapy program specifically designed to integrate targeted core and hip~     muscle strength and functional training.~   "
49359|NCT02920853|"~     The purpose of this study is to assess whether a novel, enhanced form of biofeedback can help~     individuals regulate their chronic musculoskeletal pain more effectively.~   "
49360|NCT02920840|"~     Combining TMS and EEG, this study investigates a personalized therapeutic non-invasive brain~     stimulation protocol in patients with major depression, whereby the timing of the TMS pulses~     is synchronized with the instantaneous phase of ongoing brain oscillations in order to~     modulate the inter-hemispheric left and right dorso-lateral prefrontal cortical brain~     network.~   "
49361|NCT02920827|"~     The proposed study is a single center, double-blind placebo-controlled trial to assess the~     safety and tolerability of the dapivirine ring as compared to a placebo ring when inserted~     for 28 days in 16 healthy, HIV-negative women.~   "
49401|NCT02920307|"~     Although mesh fixation has been associated to an increased incidence of nerve injury and~     involves increased operative costs, many surgeons feel that fixation is necessary to reduce~     the risk of hernia recurrence. The aim of this study is to evaluate the outcomes of~     laparoscopic herniorrhaphies performed with and without mesh fixation at our institution.~   "
49402|NCT02920294|"~     To determine the small intestinal microbiota response in humans to dietary interventions for~     two consecutive weeks, and to relate this to parameters of intestinal barrier function and~     immune and metabolic responses in blood, as functional outcome parameters of host physiology~   "
49362|NCT02920814|"~     The aims of this project are to determine the effectiveness of a time intensive form of~     Cognitive Behavioural Therapy (CBT) for Specific Phobia of Vomiting (SPOV). Current research~     shows that this brief format can be effective in other specific phobias e.g. insects and~     animals. However, to date limited research has been conducted on the effectiveness of time~     intensive forms of CBT for SPOV. A single case experimental design will be used to analyse~     specific and idiosyncratic outcome measures in 6-8 cases of SPOV, referred to the Centre for~     Anxiety Disorders and Trauma (CADAT) for treatment. Specifically, the project will explore~     the effectiveness of CBT delivered in a time-intensive format and imagery rescripting~     elements of the treatment. This initial study will provide important information about which~     elements of CBT are most effective at reducing targeted symptoms and whether symptom~     reduction can be achieved in a shorter number of sessions. It represents a crucial step~     before this format of CBT can be more rigorously evaluated and compared to other treatment~     approaches by Randomised Controlled Trial.~   "
49363|NCT02920801|"~     In this study, the investigators aim to investigate whether saxagliptin modulate endothelial~     progenitor cells number and flow-mediated dilation in newly diagnosed, treatment-naive type 2~     diabetic patients.~   "
49364|NCT02920788|"~     One of the most pressing concerns within the VA currently is the provision of interventions~     that address the cognitive as well as emotional problems faced by Veterans with mild TBI and~     comorbid conditions. When completed, these studies will inform us whether training core~     attentional self-regulatory control functions via personally-relevant activities will be~     effective in improving daily life for Veterans with mild TBI and comorbid conditions. The~     study design will provide a test not only of potential benefits for real life functioning,~     but also determine to what extent these benefits are related to actual changes in~     cognitive/behavioral performance and brain networks corresponding to these functions. This~     project will provide a foundation for future studies to investigate the neural mechanisms~     that support improvements of cognition and behavior in mTBI.~   "
49365|NCT02920775|"~     Changes in prescribing will be compared in prescribers from specialties whose prescribing is~     hypothesized to be relatively unaffected by the REMS (such as oncologists and hospice~     providers) versus those for whom the REMS could have greater impact on prescribing (e.g.,~     dentists). Trends and changes in monthly prescription volume and average monthly prescription~     volume will be evaluated by prescriber specialty.~   "
49366|NCT02920762|"~     A study will be performed to evaluate changes in prescribing behavior of prescribers of ER/LA~     opioids~   "
49367|NCT02920749|"~     The purpose of this study is to compare the perioperative hemodynamic parameters, recovery~     profiles and cost containment of sevoflurane and propofol based general anesthesia for~     otorhinolaryngeal surgery.~   "
49368|NCT02920736|"~     The purpose of this study is to determine the value of urine sTREM-1 on early predicting~     secondary acute kidney injury in sepsis~   "
49369|NCT02920723|"~     Sleep apnoea affects more than 20% of people over 65 years and is largely underdiagnosed. It~     does multiply tenfold the occurrence of vascular events, particularly stroke. While~     Continuous Positive Airway Pressure (CPAP) is currently the Gold standard treatment to~     prevent cerebrovascular and cardiovascular events, with a major clinical benefit, long term~     adherence to CPAP is a significant problem and search for alternative treatment is essential.~   "
49370|NCT02920710|"~     There is a need for a more reliable, expeditious therapy that can be used as an alternative~     to glucocorticoids in severe Central Nervous System (CNS) sarcoidosis. This study aims to~     provide evidence for effectiveness of ACTHAR gel in CNS sarcoidosis, and provide information~     about its safety and tolerability~   "
49371|NCT02920697|"~     The purpose of this study is to determine the safety profile and tolerability of S 55746 in~     patients with CLL, B-Cell NHL and MM, in terms of Dose-Limiting Toxicities (DLTs), Maximum~     Tolerated Dose (MTD) and determine the Recommended Phase 2 Dose (RP2D) through safety profile~     (DLT, MTD), PK profile, PD profile and preliminary efficacy.~   "
49372|NCT02920684|"~     Despite several positive studies, benefits of early rehabilitation on recovery and motor~     performance improvement need to be demonstrate. A recent study finds that despite early~     rehabilitation, 1 survivor of 2 (52%) acquired an ICU weakness. The low intensity exercises~     applied in intensive care is common and most patients stay in bed.~      Under these conditions, the optimal choice of the rehabilitation technique for bedridden~     patient and its intensity should be studied.~      The objective of the study is to evaluate the cardiovascular and metabolic response of~     patients during four interventions: Passive legs mobilization, Passive cycloergometter,~     Quadriceps neuromuscular electrical stimulation and Functional electrical stimulation.~   "
49373|NCT02920671|"~     Investigators are recruiting adults (men and women, ages 18 to 65 years, inclusive) with a~     confirmed genetic diagnosis of mitochondrial disease. Investigators are also recruiting both~     obese and normal-weight healthy volunteers (men and women, ages 18 to 65 years, inclusive)~     without a family history of mitochondrial disease to compare to affected individuals.~      The study involves non-invasive MRI methods and glucose tests to focus on the relationship~     between mitochondrial disease, obesity, and the risk of diabetes. All study visit procedures~     will be completed within 2 days, which includes an overnight stay at the Hospital of the~     University of Pennsylvania. There are no study medications or sedations, and participants~     will be continually monitored during minimally-invasive procedures (e.g., blood draws).~      All participants will be able to receive compensation. Furthermore, it may be possible to~     provide reimbursement for travel, lodging, and meals for individuals with mitochondrial~     disease.~      Investigators hope that this research will contribute to the current knowledge of~     mitochondrial disease and that it will improve diagnostic and treatment approaches.~   "
49374|NCT02920658|"~     This study evaluates the effectiveness of topical NAVS naphthalan in the treatment of oral~     lichen planus (OLP) and recurrent aphthous stomatitis (RAS). Half of participants with OLP~     and RAS will receive topical NAVS naphthalan in adhesive paste, while the other half will~     receive 0.05%-betamethasone dipropionate in adhesive paste. Our hypothesis is that NAVS could~     be efficient in the treatment of OLP and RAS, with effects comparable to that of topical~     steroids.~   "
49403|NCT02920281|"~     The aim of the study is to evaluate the impact of sleep quality on the length of mechanical~     ventilation weaning, in intensive care unit patients~   "
49375|NCT02920645|"~     The primary objective of this multicenter study is to validate the AVICH score in terms of~     patient outcome prediction in AVM patients with associated ICH.~      Secondary objectives are the impact of pretreatment of the AVICH score. Patients outcome is~     measured using the modified Rankin Scale (mRS) and are grouped in favorable (mRS score, 0-2)~     and unfavourable (mRS score, 3-6) outcome at last follow-up (LFU). The following parameters,~     which are part of the AVICH score, will be compared between the 2 groups: ICH score including~     age, Glasgow Coma Scale (GCS) score, haemorrhage volume, presence of intraventricular~     hemorrhage (IVH), and localization of the ICH. Spetzler-Martin grade including AVM size,~     eloquent location, and venous drainage, as well as the Lawton-Young grade, including age,~     presence of ruptured AVM, and the nidus structure. In addition pre-/postruptured treatment~     modalities, including embolization, radiotherapy, surgery or no treatment will be analysed.~     Outcome (mRS) at 3 months, at 1 year, and at LFU will be compared.~      Multicentre validation study~      Key inclusion criteria:~        -  All patients with ICH associated AVMs and a modified Rankin Scale <2 (so 0-1) before~          hemorrhage~        -  Pretreatment (embolization, radiosurgery, surgery) before ICH is not an exclusion~          criteria.~      Key exclusion criteria:~        -  incomplete data set~        -  AVM Patients with only subarachnoid hemorrhage (SAH) or IVH and no ICH~   "
49376|NCT02920632|"~     This study evaluates the efficacy of an eight-week online cognitive training program on~     objective and subjective cognitive functions in Parkinson's disease. Moreover, we intend to~     map the effect on brain network function, and if cognitive training can prevent the~     development of PD-MCI/PD-D after one- and two-year follow-up. In this study, two training~     groups will be compared (N: 70 vs 70). In a part of the participants MRI will be assessed (N:~     40 vs. 40). We expect cognitive training to improve cognitive functions, and to improve the~     efficiency of brain network function. Moreover, we expect that cognitive training can~     decrease the risk of PD-MCI/PD-D at one- and two-year follow-up.~   "
49377|NCT02920619|"~     The purpose of this study is to develop computational methods for cross-comparison of muscle~     composition measurements in three laboratory ultrasound systems.~   "
49378|NCT02920606|"~     The procedure currently recommended for the treatment of irreversible pulpitis is the~     endodontic treatment, i.e. the complete elimination of the pulp, disinfection and obturation~     of the whole root canal system. The emergency procedure consists of a pulpotomy, followed at~     an ulterior appointment by the root canal treatment. The purpose of the present pilot study~     is to evaluate the feasibility of performing the pulpotomy as a permanent treatment in mature~     molars. If hemostasis can be achieved after removing the coronal part of the pulp, a~     tricalcium silicate cement will be directly applied on the remaining pulp at the root canal~     entrances. A short-term follow-up will be performed at one week by evaluating the pain relief~     of the patient. Long-term success will then be evaluated every year by verifying the absence~     of periapical radiolucency on the x-ray as well as the absence of clinical symptoms and~     signs. A standard root canal procedure will serve as control.~   "
49379|NCT02920593|"~     The investigators aim to determine if Vitamin D prophylaxis in pregnancy reduces the~     incidence of hypertensive disorders of pregnancy.~   "
49380|NCT02920580|"~     This randomized controlled trial will enrol patients with acute severe brain injury who pass~     a spontaneous breathing trial but have decreased level of consciousness. It will directly~     compare (1) prompt extubation vs. (2) usual care, with extubation or tracheostomy timed~     according to physicians' discretion. The primary outcome will be ICU free days (days spent~     alive and outside an ICU).~   "
49381|NCT02920567|"~     This study aims to examine whether octreotide has an effect on inhibition of the exocrine~     secretion fo the pancreas, which might lower the rate of postoperative pancreatic fistula~     after pancreatoduodenectomy. Patients who will undergo pancreatoduodenectomy for~     periampullary tumors were enrolled. The patients were randomly assigned to intervention (use~     of octreotide) or placebo groups. Octreotide was injected subcutaneously every 8 hours for 7~     days. Every patients will undergo pancreaticojejunostomy with external stent for remnant~     pancreas management. The pancreatic juice is drained through the external stent by negative~     pressure and amounted.~      Primary endpoint was the amount of pancreatic juice for each postoperative day. Secondary~     endpoint was the rate of pancreatic fistula.~   "
49382|NCT02920554|"~     The extent of hepatic resection for gallbladder cancer can be done from a wedge resection to~     4b/5 bisegmentectomy. This study aims to compare the recurrence rates and survival rates~     between wedge resection group and bisegmentectomy group. Patients with T2 or T3 gallbladder~     cancer on preoperative CT exam or patients who were pathologically diagnosed as T2 or T3~     gallbladder cancer after initial simple cholecystectomy were enrolled. All patients are~     randomly assigned to wedge resection or bisegmentectomy group. Number of patients in each~     group is 44. Primary endpoint is recurrence-free-survival rates and overall survival rates.~   "
49383|NCT02920541|"~     The purpose of this study is to determine the safety profile and tolerability of S 055746 in~     patients with AML, and high or very high risk MDS, in terms of Dose-Limiting Toxicities~     (DLTs), Maximum Tolerated Dose (MTD) and determine the Recommended Phase 2 Dose (RP2D)~     through safety profile (DLT, MTD), PK profile, PD profile and preliminary efficacy.~   "
49384|NCT02920528|"~     This is a prospective, randomized controlled trial which will be conducted to determine~     whether sub-dissociative dose ketamine (SDDK) can improve pain control in subjects with~     chronic pain syndrome presenting to the emergency department with exacerbation of their~     chronic pain. The investigators also aim to determine whether use of SDDK can reduce the~     amount of subsequent opioid pain medications required for adequate pain relief in this~     population.~   "
49385|NCT02920515|"~     This is a prospective, multicentric, comparative, non-randomized interventional study in~     which subjects diagnosed with central precocious puberty (CPP) and early puberty (EP) were~     treated for 6 months to compare the effect with GnRHa and traditional Chinese medicines.~   "
49413|NCT02920151|"~     This study evaluates the effect of balance circuit in patients with more than one year of~     postoperative total hip or knee arthroplasty. Patients were randomized between intervention~     group (IG) (balance exercise circuit ) and control group (CG) (usual routine). The~     evaluations were conducted by blind examiners.~   "
49386|NCT02920502|"~     Optimal Vitamin D dosing to obtain adequate serum concentrations of 25-hydroxyvitamin D~     (25OHD) is controversial. The optimal dose and dosing interval is unknown, and the tendency~     over the last few years is to give higher, less frequent doses. Disease-specific dosing is of~     interest, and there may be optimal serum concentration targets based on disease process. The~     best evidence so far is for optimal bone health, where most experts agree that 25OHD serum~     concentration should be above 30 ng/ml.~      There is mounting evidence that Vitamin D therapy will reduce inflammatory response and~     macrophage activation. The optimal dosing needed to decrease the inflammatory response is~     unclear, although our recent mouse model has demonstrated that a onetime high dose is~     effective. The investigators therefore hypothesize that a one-time high dose of~     cholecalciferol will be effective in suppression of macrophage production of tumor necrosis~     factor-alpha (TNFa) and inducible nitric oxide synthase (iNOS). The purpose of this pilot~     study is to assess the optimum dosage for the most macrophage suppression.~   "
49387|NCT02920489|"~     Neuraxial analgesia is the gold standard to relieve labor pain. A recent Practice guidelines~     for obstetric anesthesia suggests that neuraxial analgesia should be provided in the early~     stage of labor (cervical dilation < 5 cm) or on a individualized basis. The purpose of this~     randomized controlled trial is to investigate whether neuraxial labor analgesia administered~     on an individualized basis can improve analgesia quality and maternal satisfaction.~   "
49388|NCT02920476|"~     This is a non-randomized, open label, sequentially enrolling phase II study with a Simon~     two-step enrollment design to evaluate the activity of TAS-102 in previously treated~     unresectable or metastatic squamous non-small cell cancer after progression through or~     intolerance to prior systemic therapy. The trial therapy of TAS-102 is to be administered~     orally at 35 mg/m2 each dose twice daily. The primary objective of the trial is to determine~     the progression-free survival, in months, of subjects receiving TAS 102 for the treatment of~     unresectable or metastatic recurrent squamous non-small cell lung cancers.~   "
49389|NCT02920463|"~     DetermInants of Antimicrobial use aNd de-escalAtion in critical care (DIANA study), is a~     multicenter, international, prospective, observational cohort study, aiming to describe the~     rate of de-escalation as well as the associated outcome and the empirical antibiotic therapy~     for infections at the intensive care unit.~   "
49390|NCT02920450|"~     The purpose of this research study is to determine if the study drug, Gedatolisib~     (PF-05212384), given in combination with paclitaxel and carboplatin will work against~     unresectable non-small cell lung cancer.~   "
49391|NCT02920437|"~     A pilot randomized controlled trial will be conducted to investigate the feasibility and~     effectiveness of a salt intake reduction intervention to young hypertension patients in Hong~     Kong who had high salt intake.~   "
49392|NCT02920424|"~     The purpose of this study is to assess the safety and tolerability of JNJ-56022473 following~     multiple subcutaneous (SC) study agent administrations in subjects with Systemic Lupus~     Erythematosus (SLE) and to determine whether premedication with corticosteroids is required~     to improve the tolerability of SC JNJ-56022473.~   "
49393|NCT02920411|"~     The purpose of this study is to determine the effectiveness of a combined dermatological~     treatment in children up to 5 years old with mild or moderated atopic dermatitis.~   "
49394|NCT02920398|"~     Investigating single dose pharmacokinetics and safety of turoctocog alfa pegol from the~     pivotal process and turoctocog alfa pegol from the commercial process in patients with severe~     haemophilia A~   "
49395|NCT02920385|"~     This trial is conducted in Europe. The aim of this trial is to investigate the influence of~     oral semaglutide on the pharmacokinetics (the exposure of the trial drug in the body) of~     levothyroxine and the influence of co-administered tablets on the pharmacokinetics of~     semaglutide administered orally in healthy subjects.~   "
49396|NCT02920372|"~     The study consists of generation of biological samples (in blood and urine) positive to~     Epoetin alfa for laboratories that wish to perform the analysis of doping controls and~     maintain accreditation from World Anti-Doping Agency.~   "
49397|NCT02920359|"~     The study consists of the generation of biological samples (in urine) positive to leuprorelin~     acetate for doping control by new developed methods, and establish the analytical parameters~     that reveal the administration of Leuprorelin acetate in healthy volunteers with these~     methods.~   "
49398|NCT02920346|"~     The purpose of the research study Heart Sounds at Home is for pregnant SSA or SSA/SSB~     (Sjögren syndrome B) antibody positive mothers to use a Doppler fetal heart rate monitor to~     detect abnormal heart rates and rhythms in their babies before they are born.~   "
49399|NCT02920333|"~     This study is to compare the efficacy of two types of non-invasive brain stimulation (NIBS)~     in lower limb motor function recovery in stroke patients. The intervention will be tDCS~     (transcraniel direct current stimulation) or rTMS (repetitive transcraniel magnetic~     stimulation) plus conventional gait training for 10 days over 2 weeks.~      The study hypothesizes that:~        1. When combined with conventional gait training, NIBS could improve the walking ability of~          stroke survivors.~        2. NIBS will modulate cortex activity of the brain area representing the lower limbs.~        3. The effects of NIBS might be related to some genetic factors. 45 subjects will be~          randomly divided into 3 groups, receiving tDCS plus conventional gait training, or rTMS~          plus conventional gait training, or sham tDCS plus conventional gait training.~      The outcome measures include clinical functional assessment, brain activity assessed by TMS~     measurement and MRI, genetic factor measurement. All these will be done at pre, immediate~     after intervention and 4 weeks after intervention.~   "
49400|NCT02920320|"~     In this study, people who suffer from strong self-critical tendencies will be randomized to~     two study conditions. The first group receives an account to an internet-based self-help~     intervention. The second group is a waiting control group. In both conditions additional care~     or treatment is allowed. The aim of the study is to investigate the effectiveness of an~     internet-based self-help intervention on depressive, anxiety and stress symptoms compared to~     a waiting list. Assessments are at baseline, 8-week and 6-months post-randomization. After 8~     weeks, participants in the waiting control group get also access to the intervention and fill~     out questionnaires after 8 weeks again.~   "
49404|NCT02920268|"~     Recurrent abdominal pain affects up to 37% of school-age children, mostly girls. These~     problems results in decreased quality-of-life, absence from school, lower sleep quality and~     increased health-care consumption. Long-term effects are lasting pain-symptoms and increased~     risk for psychiatric illness.~      The scientific evidence for interventions towards long-term pain in children is limited and~     pharmacological treatment is not effective. Cognitive behavioral therapy has shown some~     effect but is time- and resource consuming. Dance and yoga can enhance positive protective~     factors through better body awareness and increased self-regulation. Relaxation in yoga also~     has positive effect on abdominal pain.~      The aim of this study is to evaluate the effects of an intervention with dance and yoga for~     girls, 9 to 12 years old, with recurrent abdominal pain. The participants will be identified~     through pediatric clinics in Örebro County, primary health care and school health care. They~     will be randomized to intervention with weekly dance- and yoga class for 8 months or control~     group with standard treatment. Primary outcome is the fraction of girls in each group who,~     direct after intervention, has decreased their maximum pain measured by Faces Pain Scale.~     Secondary outcomes are stress, psychical health, well-being, school and sleep functions,~     physical activity and health-economy. The study group will be followed up for two years.~      Just-in-TIME is an interdisciplinary research group with expertise in interventions for~     psychosomatic problems in children and adolescents. TIME, which stands for Try, Identify,~     Move and Enjoy, also characterizes this project, aiming at decreasing recurrent abdominal~     pain through an intervention with dance and yoga for 9-12 year old girls.~   "
49405|NCT02920255|"~     The objective is to compare the accuracy and reproducibility of measurements taken with~     electronic calipers and conventional calipers. Using both calipers, reproducibility will be~     determined by comparing results from a number of practitioners and accuracy will be~     determined by comparing results with those obtained from X-rays.~   "
49406|NCT02920242|"~     This study will compare safety and efficacy of a generic rifaximin tablet to the reference~     listed drug in the treatment of travelers' diarrhea. Additionally both the generic and~     reference formulations will be tested for superiority against a placebo tablet.~   "
49407|NCT02920229|"~     Single-center, prospective, diagnostic trial in radically treated patients with biochemical~     recurrence of prostate cancer. Patients with radically treated prostate cancer with~     biochemical relapse and negativity of all traditional morphological and functional imaging~     (transrectal ultrasound, bone scan, 18F-FMC PET/CT, CT/MRI) or doubtful imaging of~     2-deoxy-2-[fluorine-18] (18F)-fluoromethylcholine (FMC) PET/CT will receive a Gallio-68~     (68Ga)- Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET)/Computed~     Tomography (CT) scan.~   "
49408|NCT02920216|"~     Treatment of Head and Neck Squamous cell carcinoma often combines chemoradiotherapy when~     organ has to be preserved or when surgery is not indicated. The loco-regional failure is~     about 30%. Then salvage surgery is the only chance for patients to survive but the overall~     survival rate is only 29% at 24 months. This prognostic is bad because of poor local control~     which is non-optimized by a complementary radiotherapy and negative exeresis margins.~      Currently, there is no intraoperative technique to better visualize the tumor limits in real~     time. With fluorescence techniques, an accurate mapping of tumor extension can be considered.~     Recently, Atallah et al. (2015) demonstrated the use of fluorescence during a head and neck~     surgery in mice, as a tool allowing for better surgical margins. Digonnet et al (2015) found~     a tumor fragment after an injection of indocyanine green (ICG) intravenously in salvage~     surgery for patient with head and neck cancer.~      The ability of ICG to detect a surgical margin positive intraoperatively has never be~     evaluated in irradiated area.~      The aim of this pilot study is to evaluate the interest of fluorescence in salvage surgery~     for recurrence of head and neck cancer in irradiated area.~   "
49409|NCT02920203|"~     The purpose of the study is to better identify hereditary cardiac causes of sudden unexpected~     death in young subjects through Next-Generation Sequencing of autopsy tissue~   "
49410|NCT02920190|"~     Background~      Antigen-driven selection has been implicated in the pathogenesis of monoclonal gammopathies.~     Patients with Gaucher's disease have an increased risk of monoclonal gammopathies and~     symptomatic myeloma. Clonal immunoglobulin in patients with Gaucher's disease and in mouse~     models of Gaucher's disease-associated gammopathy are reactive against lyso-glucosylceramide~     (LGL1), which is markedly elevated in these patients and mice. A recent report indicates that~     clonal immunoglobulins in 33% of sporadic human monoclonal gammopathies may also be specific~     for the lysolipids LGL1 and lysophosphatidylcholine. Substrate reduction ameliorates~     Gaucher's disease-associated gammopathy in mice. This principle (that antigen removal can~     induce tumor regression) has been proven in other hematologic malignancies, where H. Pylori~     eradication causes lymphoma regression is a significant group of patients. Thus, as longterm~     immune activation by lysolipids may underlie both Gaucher's disease-associated gammopathies~     and some sporadic monoclonal gammopathies, this may represent a focus for treatment.~      Epicardial fat (EAT), the visceral fat of the heart, is highly enriched in genes involved in~     inflammation and lipid metabolism; it activates local and systemic inflammation and innate~     inflammatory response. EAT is rich in saturated fatty acids and has high protein content, and~     the greatest capacity for free fatty acids release and uptake among any other visceral fat~     depots. Of interest, EAT is highly enriched in sphingolipids, including ceramide. EAT~     clinical measurability with an ultrasound technique, first developed and validated by~     Iacobellis, and its rapid responsiveness and reduction to medications targeting the visceral~     fat, such as the glucagon-like peptide 1 analogues (GLP1A), as ongoing clinical trials are~     demonstrating, is of growing and remarkable interest.~      Study Hypothesis~      To target EAT, as marker of visceral fat, with GLP1A treatment to modulate/reduce/remove the~     antigen(s) (lipid/inflammatory/immune) stimulation for patients with monoclonal gammopathies~     that are lipid targeted.~      Study Design~      Interventional, single-group, open label pilot study. The investigators will identify~     monoclonal gammopathy patients whose antibodies are lipid/visceral fat targeted (goal is 10~     initially as a pilot) and who are overweight/obese (BMI > 27). Eligible patients will be~     started on Liraglutide up to 1.8 mg sc once daily, as adjunct weight loss treatment for 12~     months.~      Study Endpoints~        -  Ultrasound measured EAT reduction by at least 20%~        -  Improvement in the monoclonal immunoglobulin profile Reduction in plasma ceramide and~          lipidomics levels~      Parameters will be monitored at 3 months, 6 months and 12 months.~   "
49411|NCT02920177|"~     The purpose of this study is to compare the clinical response of intra-articular platelet~     rich plasma (PRP) versus corticosteroid injection in patients affected by femoroacetabular~     impingement (FAI).~   "
49412|NCT02920164|"~     Title of the study: Auricular acupuncture (AA) for pre-exam anxiety: A blinded randomized~     crossover study on healthy volunteers~      Study period: 04/2012 - 07/2012~      Institution: Department of Anesthesiology and Intensive Care Medicine University Medicine of~     Greifswald~      Aim of the study: To investigate the anxiolytic effect of auricular acupuncture (AA) in~     comparison to placebo acupuncture and no intervention during oral exams in anatomy at the~     University of Greifswald~      Design: Prospective blinded randomized crossover trial~      Intervention:~        1. AA using indwelling fixed needles, retained 24 h in situ~        2. AA using placebo needles~      Number of volunteers: N = 40~      Outcome measures: Anxiety level, Heart rate, blood pressure.~   "
49414|NCT02920138|"~     Background: Study was designed to determine the effect of zero (ZEEP) and 5 mmHg positive end~     expiratory pressure (5PEEP) on serebral oxymeter levels in morbid obese patients whose~     undergoing laporoscopic sleewe gastrectomy. Second outcome is to investigate the effect of~     IAP changes on cerebral oxygen values in LSG.~      Method:18-65 yo, ASA2-3 status, 60 MO patients which planned SLG under general anesthesia~     were included.Two patient in Group 5 PEEP were excluded because of the haemodynamic~     instability during procedure. Patients were divided into 2 groups which was ventilated with~     no PEEP (Group ZEEP)(n=30) and 5 cmH2O PEEP levels (Group5 PEEP)(n=28). All patients were use~     right hand dominant. Near infrared spectroscopy probes were applied to both frontal cerebral~     area of all patiens and measured rSO2 values. IAP were measured transvesically in all groups.~     Datas were recorded as basal, after induction of anesthesia, 5 minute before~     insuflation(5BI), 5 minute after insuflation(5BA), 15, 30, 45, 60 minute after induction, 5~     minute before desuflation(5BD) and 5 minute after desuflation(5AD) time periods. Invasive~     arterial pressures, serebral oxymeter values, 5 lead electrocardiography, peripheral oxygen~     saturation, end tidal carbondioxide, peak inspiratory pressures, IAP, were recorded time~     periods in all groups. Arterial blood sample analysed on 5BI,5AI, 5AD periods.~   "
49415|NCT02920125|"~     To evaluate the benefits of Ayurvedic SUVED & REIMMUGEN Colostrum for reduction/reversal of~     symptoms and study clinical progress in Vascular disease; CAD, CAV, Stroke, DVT patients.~   "
49416|NCT02920112|"~     This second phase of a pilot study (non-drug) will examine the effectiveness and feasibility~     of Telephone based Cognitive Behavioural Therapy (Tele-CBT) as an additional treatment to the~     usual standard of care in bariatric surgery patients. Participants one year post-surgery will~     receive six sessions of Tele-CBT and complete measures before, during, immediately after, and~     one year after participation in the study.~   "
49417|NCT02920099|"~     The purpose of this study is to develop a tool to help researchers better understand what~     diet information people know and what skills they use to make diet choices.~   "
49418|NCT02920086|"~     The purpose of this study is to improve the outcomes of critically ill older patients and the~     health outcomes of their families by capacitating and partnering with families in optimizing~     patient/family centered care.~   "
49419|NCT02920073|"~     The objective of this trial is to evaluate gut microbiota changes in undernourished patients~     with anorexia nervosa under enteral nutrition.~   "
49420|NCT02920060|"~     This study is a randomized, open label, parallel group,comparing the safety and efficacy of~     valproate and levetiracetam in patients of age group 1 to 16 years with status epilepticus~     not responded to phenytoin and benzodiazepines approaching to pediatric emergency , IMS, BHU.~     The primary outcome measures will be Proportion of children in either group who have~     Cessation of all clinical seizure within 30 min of drug administration and secondary outcome~     will be time taken to control seizure (minutes) from the initiation of infusion. Proportion~     of children in either group who required additional drugs to abort ongoing clinical seizures,~     rates of adverse events (hypotension, bradycardia, respiratory depression, PICU stay, in~     hospital mortality) in the two groups were measured. Refractory status epilepticus condition~     is major pediatric neurological emergency with high mortality and morbidity. Till now, the~     treatment guidelines for it are based primarily on retrospective studies with very few~     randomized studies. There is lack of sufficient data to recommend one drug over another for~     treatment of refractory status epilepticus.~   "
49421|NCT02920047|"~     The purpose of this study is to evaluate the pharmacokinetics and safety when administrated~     Fimasartan/Amlodipine and when co-administrated Fimasartan and Amlodipine.~   "
49422|NCT02920034|"~     Prospective, randomized trial to assess the effectiveness of different renal sympathetic~     denervation methods (radiofrequency main vs. branches + main vs. ultrasound based) in a~     cohort of patients with therapy refractory arterial hypertension and large renal arteries~   "
49423|NCT02920021|"~     The purpose of this study is to determine ANB020 safety, tolerability and activity in adult~     patients with peanut allergy.~   "
49424|NCT02920008|"~     Multicenter, randomized, open-label, parallel-group study of guadecitabine vs treatment~     choice (TC). Subjects will be randomly assigned in a 1:1 ratio to either guadecitabine or TC.~     TC options include the 8 high or low intensity, locally available regimens below; or Best~     supportive Care (BSC) alone:~        -  High intensity (intermediate or high dose cytarabine [HiDAC]; mitoxantrone, etoposide,~          and cytarabine [MEC]; or fludarabine, cytarabine, granulocyte colony stimulating factor~          [G-CSF], +/- idarubicin [FLAG/FLAG-Ida]).~        -  Low intensity (low dose cytarabine [LDAC], decitabine, or azacitidine).~        -  BSC.~   "
49425|NCT02919995|"~     This study evaluates two doses of RPL554 and placebo in adult patients with cystic fibrosis.~     All patients receive all three treatments in a randomised sequence.~   "
49426|NCT02919982|"~     The purpose of this study is to establish a benchmark for rate of prescription of oral~     anticoagulants (OA) in patients with non-valvular atrial fibrillation (NVAF) seen in an~     ambulatory care setting, based on independent medical assessment of clinical data and~     physician and patient surveys. The study will also assess reasons for not prescribing OA to~     prevent thromboembolic complications in patients with NVAF seen in ambulatory care, and~     patients' perspectives of non-use of OA for treatment of NVAF.~   "
49427|NCT02919969|"~     This research study is studying a targeted therapy as a possible treatment for advanced anal~     cancer.~      The following intervention will be involved in this study:~      -Pembrolizumab~   "
49428|NCT02919956|"~     Single ventricle lesions are the leading cause of illness and death from congenital heart~     disease. The modified Fontan Operation is the corrective surgery for these lesions. The~     operation is done in stages over a few years and children who complete the operation are~     known to have greater neurodevelopmental (ND) deficits than the general population. The~     purpose of this study is to understand how blood flow to the brain (CBF) and brain lesions~     relate to ND outcome, as well as how CMRO2 relates to anatomic brain lesions. These~     relationships will be studied through Magnetic Resonance Imaging (MRI) and ND Testing.~   "
49429|NCT02919943|"~     To define and evaluate the impact of angiographic coregistered OCT on physicians~     decision-making through prospective data collection in PCI procedures.~   "
49430|NCT02919930|"~     The purpose of this study is to compare the effects of nasal and oronasal interfaces during~     ASV treatment on sleep efficiency and sleep architecture. Therefore, patients starting~     treatment with ASV, will be randomized between two groups. In the first group, patients will~     use a nasal interface during the first night and an oronasal interface during the second~     night. In the second group, patients will use an oronasal mask first and a nasal mask during~     the second night. The results of this trial will have major impact on future clinical~     practice as it would deliver prediction rules to choose the correct interface immediately.~   "
49431|NCT02919917|"~     While treatment strategies for OH have been identified for use in persons with acute SCI, the~     field of SCI medicine lacks a gold standard for treatment thresholds and well-defined outcome~     parameters. Comprehensively documenting the impact of orthostatic hypotension (OH),~     regardless of symptoms, during acute rehabilitation and identifying the effects of two~     different treatment approaches on therapy participation and adherence to an intended~     rehabilitation plan could have a significant impact on clinical practice in the acute~     rehabilitation setting following SCI.~   "
49432|NCT02919904|"~     The feasibility of using the Apnea Risk Evaluating System (ARESTM) device to take~     longitudinal measures of sleep parameters in asymptomatic men with prostate cancer who are~     about to initiate androgen deprivation therapy (ADT) will be evaluated. Study participants~     will complete serial questionnaires relating to sleep quality, hot flashes, and quality of~     life.~   "
49433|NCT02919891|"~     This is a retrospective, observational study which will utilise the Edinburgh Cancer Research~     Centre's Tissue Bank to provide samples for IENFD testing in those who have undergone~     mastectomy surgery for breast cancer.~      The investigators shall identify all those patients in the Tissue Bank database who have~     undergone mastectomy surgery for breast cancer. The investigators shall consult the patient's~     electronic health record, and general practitioner if required, to ascertain whether the~     patient has died, been diagnosed with cognitive impairment or a psychotic disorder, or~     receiving ongoing oncological treatment which would exclude them from the study. The~     investigators shall also exclude all those patients who received surgery within the last year~     as we intend to elucidate the presence of pain in the immediate post-operartive period up to~     12 months post-operatively.~      Having identified these patients the investigators shall contact them via post with a pack~     containing an information document, a consent form and questionnaires. As this is an~     observational study we shall contact all of the identified patients who meet the inclusion~     criteria with the aim of recruiting as many as possible. The investigators would anticipate a~     high response rate as has been the experience with previous questionnaire studies of breast~     cancer patients.~      Once a signed consent form has been returned the patient's tissue sample would undergo IENFD~     testing. Their questionnaire responses will allow participants to be split into two groups~     based upon whether they experience CPSP or not. Blinding of this grouping will take place so~     that those undertaking the IENFD testing are unaware of the patient's questionnaire~     responses.~      Statistical analysis of the two group's IEFD results and questionnaire responses will then be~     undertaken with the null hypothesis that the pre-operative IENFD at the site of surgery does~     not predict or correlate with CPSP.~   "
49434|NCT02919878|"~     Phase II Study of Neo-adjuvant Chemoradiotherapy using infusional Gemcitabine followed by~     Surgery for Locally Advanced (T3 and T4 or Node positive) Rectal Adenocarcinoma.~   "
49435|NCT02919865|"~     Radiation therapy is an important adjunct in the treatment of patients with glioma, although~     a common side effect is radiation-induced injury of brain parenchyma. Unfortunately,~     conventional MRI is not accurate in differentiating radiation-induced brain injury from~     recurrent tumour, both of which may demonstrate progressive contrast enhancement. Recent~     studies have suggested that perfusion MRI could improve this differentiation. Perfusion MRI~     can be performed with an injection of exogenous contrast using dynamic contrast enhancement~     (DCE) or dynamic susceptibility contrast enhancement (DSC). Perfusion MRI can also be~     performed without contrast injection using arterial spin labeling (ASL) or intravoxel~     incoherent motion (IVIM). DCE-MRI relies on accurate measurement of T1 values in order to~     convert the MRI signal intensity to contrast concentration. Dynamic susceptibility-weighted~     contrast enhancement (DSC) perfusion is the most common technique used in clinical practice~     but measurement of tumor relative cerebral blood volume (rCBV) can be biased by extravascular~     contrast leakage and susceptibility-weighted artifacts. The purpose of this study is to~     evaluate the accuracy of perfusion MR imaging using non-contrast and contrast-based~     techniques in differentiating recurrent tumour from radiation-induced brain injury in~     patients with known high grade glioma. The investigators will compare the accuracy of IVIM,~     ASL, DCE and DSC techniques. A secondary goal of the study is to compare two new different T1~     mapping methods used for DCE-MRI.~   "
49436|NCT02919852|"~     The purpose of this study is to identify whether a new operative technic would be acceptable~     in female with pelvic organ prolapse.~   "
49437|NCT02919839|"~     Personalized medicine methods in the management of type 1 diabetes~   "
49438|NCT02919826|"~     To determine the feasibility and effectiveness of a RCT of an adapted DBT group delivered to~     individuals with ID and emotional dysregulation.~   "
49439|NCT02919813|"~     The purpose of this study is to learn more about Mindfulness based Group Cognitive Behavior~     Therapy (M-gCBT) as a treatment for Provoked Localized Vulvodynia (PLV). M-gCBT is a~     counseling technique that has been shown to reduce pain and anxiety with other medical~     conditions, including chronic pain conditions. The investigators wish to see if participation~     in M-gCBT course will help reduce anxiety, fear, and pain in women with PLV greater than~     education alone. Both techniques use a group setting including other women with PLV.~     Mindfulness-Based Group Cognitive Behavior Therapy for Women with Localized Vulvodynia is a~     study designed to learn more about the use of mindfulness based group cognitive behavior~     therapy for PLV pain and anxiety over education alone. Participants will be randomized to one~     of two groups: mindfulness based cognitive behavior therapy or group education seminars.~   "
49440|NCT02919800|"~     A Phase 1, randomized, single-blind, placebo-controlled, single dose, dose-escalation study~     to assess the safety, pharmacokinetic and pharmacodynamic profile of subcutaneous~     administration of a long-acting recombinant factor VIIa (MOD-5014) in healthy adult males.~   "
49441|NCT02919787|"~     This study evaluate the additional effect of adding chemotherapy prior to resection of a~     pancreatic head malignancy. The patients will be randomized into two groups; surgery first~     (control group) and neoadjuvant chemotherapy (intervention). Primary endpoint is overall~     survival after resection~   "
49442|NCT02919774|"~     The study will evaluate the effects of the mGluR2/3 partial agonist LY2140023 (Pomaglumetad~     Methionil, POMA) at selected doses on ketamine-stimulated glutamate release in prefrontal~     cortex as measured by pharmacoBOLD fMRI (also termed resting BOLD fMRI).~   "
49443|NCT02919761|"~     2 part multicenter study to examine the effect of Acthar in adult subjects with rheumatoid~     arthritis (RA) with persistently active disease. Part 1 is an Open Label Period in which all~     eligible subjects receive Acthar for 12 weeks. After 12 weeks of treatment with Acthar,~     subjects will be evaluated for treatment response using the DAS28-ESR. Subjects who have~     achieved low disease activity will enter a double-blind randomized maintenance period (Part~     2) and be randomized in a 1:1 ratio to receive either Acthar or matching placebo for an~     additional 12 weeks.~   "
49444|NCT02919748|"~     To evaluate the efficacy of choral singing in the prevention of dementia and examine the~     underlying mechanisms using Magnetic Resonance Imaging (MRI) technique and a panel of~     peripheral biomarkers in venous blood and urine. The investigators hypothesize that Choral~     singing could prevent cognitive decline among community-dwelling elderly who are at high risk~     of dementia. The underlying neural mechanisms involve the changes in brain structure and~     function that can be quantified using MRI technique. The changes in cognitive outcomes will~     be accompanied by observable changes from a panel of carefully selected peripheral~     biomarkers.~   "
49445|NCT02919735|"~     Phase II clinical trial~   "
49446|NCT02919722|"~     Investigators hypothesize, based on anecdotal evidence to date, that active music making~     interventions conducted on a patient's neglected side will result in improved attention to~     that side and that this will be measurable within session.~   "
49447|NCT02919709|"~     The study aims to investigate the existence of a reliable correlation between the progression~     of aortic diameters and blood levels of circulant endothelial progenitor cells CD34+ in~     patients with not surgical aortic aneurysms.~   "
49448|NCT02919696|"~     The purpose of this study is to determine the safety of the study drug known as abemaciclib~     in native Chinese participants with advanced and/or metastatic cancers.~   "
49449|NCT02919683|"~     This research study is studying nivolumab, an investigational drug, in combination with~     ipilimumab, also an investigational drug, as a possible treatment for Squamous Cell Carcinoma~     of the oral cavity.~      The following drugs are involved in this study:~        -  Nivolumab (Opdivo™)~        -  Ipilimumab (Yervoy™)~   "
49450|NCT02919670|"~     This research study is evaluating Enterade, a supplement, as a possible treatment for the~     side effects caused by Stem Cell Transplant.~      The following interventions will be involved in this study:~        -  Enterade plus standard supportive care~        -  Placebo plus standard supportive care. The placebo will be a mixture of water,~          electrolytes, and sweetener.~   "
49451|NCT02919657|"~     Genepro Gen2 Absorption and Protein Value Clinical Trial.~   "
49452|NCT02919644|"~     Single-arm, monocentric trial to assess safety and immunological efficacy of adjuvant~     vaccination with autologous dendritic cells loaded with autologous tumour homogenate after~     curative resection for stage IV colorectal cancer~   "
49453|NCT02919631|"~     Background: Patients with the sugar metabolism disorder, Glycogen Storage Disease Type V,~     have insufficient breakdown of sugar stored as, glycogen, within the cells. The investigators~     know from previous studies with McArdle patients, that they not only have a reduced sugar~     metabolism, both also have problems in increasing their fat metabolism during exercise to~     fully compensate for the energy deficiency.~      Studies on Triheptanoin diet used in patients with other metabolic diseases have shown that~     Triheptanoin can increase metabolism of both fat and sugar. In these patients, Triheptanoin~     has had a positive effect on the physical performance and has reduces the level of symptoms~     experienced by patients.~      Aim: To investigate the effect of treatment with the dietary oil, Triheptanoin, in patients~     with McArdle disease on exercise capacity.~      Methods: 20-30 adult patients will be recruited through Rigshospitalet in Copenhagen, Denmark~     and Hopital Pitié-Sapêtrière in Paris, France.~        1. Pre-experimental testing (1 day): Baseline blood samples are collected to obtain~          baseline values of safety parameters: Plasma-acylcarnitines, free fatty acids and~          creatine kinase. Subjects perform a max-test to determine their VO2max~        2. Treatment period #1 (2 weeks): Subjects follow a diet consuming a dietary treatment oil.~          Neither patients nor members of the study group know who receive which type of oil.~        3. Washout period (1 week +7 days): Subjects receive no treatment~        4. Treatment period #2 (2 weeks +7days): Subjects who received Triheptanoin oil in the~          first treatment period, now receive placebo oil and vice versa.~      Assessments: Before and after each treatment periods, subjects perform a 30-minutes exercise~     test on a cycle ergometer, comprising of 20-22 minutes of constant load exercise and 6-8~     minutes increasing load to peak. Subjects will complete a Fatigue Severity Scale~     questionnaire and metabolic products will be measured in blood and urine.~   "
49454|NCT02919618|"~     Phase I/II Study of EP-guided Noninvasive Cardiac Radioablation (ENCORE) for Treatment of~     Ventricular Tachycardia~   "
49455|NCT02919605|"~     Introduction: Up to the present, have been few studies with pentamidine in the Americas; and~     there is no consensus regarding the dose used.~      Objectives: To evaluate the use of pentamidine in single dose, double and triplo in the~     treatment of cutaneous leishmaniasis.~      Methods: Clinical trial of phase II pilot study with 159 patients. Pentamidine will be used~     at a dose of 7 mg/kg, in three arms: single dose, double dose and triple dose. They will be~     also assessed the safety and adverse effects. The sic will be reviewed one, two and six~     months after the end of the treatments.~   "
49456|NCT02919592|"~     The purpose of this study is to collect additional post-approval clinical data on the~     long-term performance of MemoryShape and MemoryGel Breast Implants, as indicated for primary~     or revisional breast augmentation and primary or revisional breast reconstruction.~   "
49457|NCT02919579|"~     The primary purpose of this study is to evaluate the effect of a single 84-milligram (mg)~     dose of intranasal esketamine compared to placebo, on next day driving performance and~     repeated administration of 84 mg intranasal esketamine on same-day driving performance as~     assessed by the mean difference of standard deviation of lateral position (SDLP) from an~     on-road driving test.~   "
49458|NCT02919553|"~     The purpose of the study is to compare two particular techniques of tissue (capillary vs~     wet-suction techniques) sampling during endoscopic ultrasound guided fine needle~     aspiration/biopsy (EUS-FNA/FNB) of a solid lesion to determine the diagnostic yield and~     procedure logistics (e.g. procedure time).~   "
49459|NCT02919540|"~     This project aims at testing the effect of applying the KMC on the premature infants'~     physiological outcomes. The findings of this project are expected to contribute to the~     discipline of preterm infants' care by providing evidence of the benefits, barriers, and~     facilities of providing the KMC in our Jordanian NICUs.~   "
49475|NCT02919332|"~     This clinical trial studies how well delayed fludeoxyglucose F-18 (18F-FDG) positron emission~     tomography (PET)/computed tomography (CT) works in improving visualization of brain tumors in~     patients with glioblastoma. Radiotracers such as 18F-FDG are highly taken up by tumors in the~     brain and are visualized using PET/CT. Increasing the interval of time between 18F-FDG~     administration and PET/CT scan may improve the visualization of brain tumors in patients with~     glioblastoma.~   "
49460|NCT02919527|"~     Treatment or training of fascial tissues has moved into the focus of medical research in the~     last decade. In this context, the use of foam rollers or roller massagers for~     self-myofascial-release (SMR) techniques has become increasingly popular in health and~     fitness professionals. The primary objective of these techniques is to mimic manual massage~     or myofascial-release therapy with a self-usable tool. Recent studies suggest that SMR~     improves, inter alia, range of motion (ROM) without a decrease in neuromuscular performance~     (Cheatham et al. 2015).~      Concurrent effects on the muscle and especially the surrounding connective tissue network~     have been proposed as underlying mechanisms for these observed changes in ROM after SMR.~     Several authors assume a positive effect of SMR on sliding properties of different~     independent fascial layers. Also, changes in passive tissue stiffness is suggested. Passive~     stiffness is thereby characterized by passive resistance in the tissues' (muscles')~     functional direction, the passive resistive torque (PRT).~      In conclusion, for many of the proclaimed effects of SMR, such as improvements of sliding of~     fascial layers or decreases of passive stiffness, there is a lack of evidence in the~     literature. Therefore, the aim of the study is to evaluate acute effects of SMR on the~     viscoelastic properties of the muscles on the anterior thigh and the corresponding fascia.~      In a cross over design, 16 subjects receive all of the following interventions after a~     familiarization session: a) 2x60 seconds of SMR at the anterior thigh, b) 2x60 seconds of~     static stretching at the anterior thigh, c) no intervention in a balanced permutated~     randomization sequence. Before and directly after each intervention, outcome parameters are~     collected.~      Passive Resistive Torque is evaluated using a computerized isokinetic dynamometer. In passive~     mode, the lower leg is moved from full knee extension (0°) to the point of maximal knee~     flexion with a velocity of 5°/s. Torque and angle are recorded at 100 Hertz (Hz). Sliding of~     fascial layers is quantified with a frame-by-frame cross correlation algorithm of~     high-resolution ultrasound images (Dilley et al. 2001).~      First stretch sensation is quantified using the passive mode in the isokinetic dynamometer.~      Maximal ROM is detected using a an ultrasonographic movement analysis system in a prone~     position.~   "
49461|NCT02919514|"~     To investigate effects of soft, sand and hard surfaces on functional ability and falls in~     elderly with or without history of multiple falls.~   "
49462|NCT02919501|"~     To evaluate the early onset of efficacy of vortioxetine 17 mg intravenously (IV) and~     vortioxetine 10 mg/day oral dose regimen versus vortioxetine 10 mg/day oral dose regimen on~     depressive symptoms~   "
49463|NCT02919488|"~     The purpose of this study is to determine if postprandial (after a meal) endothelial (inner~     lining of blood vessels) dysfunction induced by a high sugar meal improves with a bout of~     exercise~   "
49464|NCT02919475|"~     This study will evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of~     JTE-051 administered for 12 weeks in subjects with active rheumatoid arthritis who are~     receiving background non-biologic disease-modifying anti-rheumatic drug therapy.~   "
49465|NCT02919462|"~     This is an open-label, multicentre, randomized phase II trial.~      Eligible patients with Non Small Cell Lung Cancer (NSCLC) with high Thymidylate Synthase (TS)~     expression , will be randomly assigned with 1:1 ratio to the following treatment Arms:~      A. 4 cycles of Cisplatin + Oral Vinorelbine followed by maintenance with Metronomic Oral~     Vinorelbine until disease progression~      B. 4 cycles of Cisplatin + Pemetrexed followed by maintenance with Pemetrexed until disease~     progression~      Treatment will be repeated every 21 days .~   "
49466|NCT02919449|"~     This a Phase 1 study designed to determine the maximum tolerated dose (MTD) and toxicity of~     attenuated Measles virus (MV-NIS) combined with Atezolizumab in patients with recurrent and~     metastatic NSCLC.~   "
49467|NCT02919436|"~     Randomization (1:1) of male patients, over age 50, undergoing elective spine surgery to~     tamsulosin versus a placebo.~   "
49468|NCT02919423|"~     The purpose of this study is to investigate the modulatory effects of repetitive transcranial~     magnetic stimulation (rTMS) on functional connectivity with the insula. Functional~     connectivity (FC) measures the interaction between brain regions, and recent neuroimaging~     studies have used FC to investigate how addiction affects FC among pertinent brain regions.~     rTMS, which can excite cortical neurons, has shown promise as a method to manipulate brain~     connectivity and could be used therapeutically to treat addiction. However, investigators~     first need more information on brain FC and how it relates to behavior, in order to guide~     rTMS target selection.~   "
49469|NCT02919410|"~     This is a prospective, randomized control trial evaluating the efficacy of~     iodophor-impregnated adhesive drapes for reducing bacterial count in hip surgery.~   "
49470|NCT02919397|"~     The overall aim of this feasibility trial is to assess the effectiveness of a wearable~     technology and an e-diabetes prevention programme delivered via a smartphone application,~     including motivational messaging, in reducing weight and increasing physical activity in~     people at risk of developing type 2 diabetes.~   "
49471|NCT02919384|"~     During this study, patients will undergo a routine in vitro fertilization cycle as they would~     otherwise if not participating in the study. After eggs have been fertilized they will be~     cultured as usual until day 3 of embryo development. On day 3 of development, the~     embryologist will randomize half of the embryos to be cultured in 2% oxygen concentration and~     the other half at 5%, which is currently the standard of care. All other embryological care~     procedures will remain the same. On day 5 or 6 of embryo development, the embryos will be~     evaluated and each blastocyst stage embryo will be recorded. The primary outcome will be the~     blastulation rate (or percentage of embryos that reach the blastocyst stage).~   "
49472|NCT02919371|"~     Combined sunitinib and bevacizumab in advanced renal cell carcinoma.~   "
49473|NCT02919358|"~     The purpose of this study is to investigate the effect of classical music exposure on~     improved time to regain birth weight and improved feeding readiness in healthy premature~     infants in the NICU.~   "
49474|NCT02919345|"~     Background Endothelial dysfunction is one of the early events in atherosclerotic plaque~     development. It is characterized by an increased ratio of substances with vasoconstrictive,~     pro-thrombotic, and proliferative properties over substances with vasolidatory,~     antithrombogenic and antimitogenic properties. Endothelial dysfunction is also associated~     with high-risk patients with coronary artery disease. Hyperglycemia, obesity, hypertension~     and fat mass also impair the endothelium by increasing the expression of cytokines,~     inflammatory markers and vascular markers.~      Hypothesis Administration of dapagliflozin in addition to metformin background with clinical~     or subclinical cardiovascular atherosclerotic disease improves endothelial function when~     compared to those using glibenclamide in addition to metformin.~      Objectives Evaluate the effect of dapagliflozin vs glibenclamide on a metformin background on~     endothelial function in patients with clinical or subclinical cardiovascular atherosclerotic~     disease and poorly controlled diabetes.~      Enpoints Prymary Change in flow mediated dilation (FMD) and its related endpoint (FMD post~     reperfusion lesion) between the randomization visit and over 12 weeks of treatment.~      Secondary Change in plasma nitric oxide, isoprostane, ICAM-1, VCAM-1, ET-1, leptin,~     adiponectin, C-reactive protein, TNF- α, interleukin-6, interleukin-2, weight and body~     composition (% of fat mass and % free fat mass) at the randomization visit and over 12 weeks~     of treatment.~      3~      Design Randomized, parallel-group, comparative, prospective clinical study. The study is~     divided in two phases: Run-in and Randomization. In the former phase, which must have the~     maximum period of 16 weeks, patients will visit the outpatient to adjust metformin and blood~     pressure medications. After run-in phase, patients that fulfill inclusion criteria will~     perform an ambulatory blood pressure monitoring (ABPM) in order to asses BP; body composition~     will be assessed by dual x-ray absorptiometry (DXA); endothelial function as assessed by flow~     mediated dilation and vascular cytokines. Patients will by randomized to dapagliflozin or~     glibenclamide on a metformin background. After 12 weeks, the ABPM, DXA and endothelial~     function will be assessed.~   "
49477|NCT02919306|"~     The purpose of the study is to assess: 1 safety and tolerability of adenovirus serotype 26~     (Ad26) prime and Modified Vaccinia Ankara (MVA) boost versus placebo in participants on~     suppressive antiretroviral therapy (ART) that was initiated during acute Human~     Immunodeficiency Virus (HIV) infection; 2) Measure the frequency and duration of sustained~     viremic control after receiving Ad26 prime/MVA boost or placebo, defined as greater than 24~     weeks with plasma HIV ribonucleic acid (RNA) lesser than (<)50 copies/ml after antiretroviral~     (ARV) analytical treatment interruption (ATI).~   "
49478|NCT02919293|"~     To evaluate Immunogenicity and Safety of Adjuvant and Adjuvant-Free Meningococcal Groups A~     and C and Haemophilus b Conjugate Vaccine in Infants 2 to 5 Months of Age.~      Primary objective:~        -  To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups~          A, C and Haemophilus influenzae type b following the administration of adjuvant-free~          MenAC-Hib conjugate vaccine compared to those observed following the administration of~          adjuvant MenAC-Hib conjugate vaccine.~        -  To describe the safety profile of adjuvant-free MenAC-Hib conjugate vaccine compared to~          that of adjuvant MenAC-Hib conjugate vaccine.~      Secondary objective:~      •To compare the antibody level of meningococcal serogroups A, C and Haemophilus influenzae~     type b following the administration of adjuvant-free MenAC-Hib conjugate vaccine to those~     observed following the administration of adjuvant MenAC-Hib conjugate vaccine.~   "
49479|NCT02919280|"~     The Dallas 2K is a 10-year natural history, longitudinal, prospective study of a cohort of~     2,000 participants that will help uncover the socio-demographic, lifestyle, clinical,~     psychological and neurobiological factors that contribute to anti-depressant treatment~     response: remission, recurrence, relapse and individual outcomes in depressive disorders.~     Hence, the expected duration of this study is 20 years in length. Since this is an~     observational study, investigators will explore a comprehensive panel of carefully selected~     participant specific parameters: socio-demographic (age, ethnicity, economic); lifestyle~     (physical activity, substance use); clinical (medical history, anxious depression, early life~     trauma), biological (biomarkers in blood, saliva, urine), behavioral (cognitive, emotional),~     neurophysiological (EEG), and neuroimaging (structural, functional brain circuitry) with the~     goal to develop the most robust predictive models of treatment response and of depression~     outcomes. There is no medication or non-medication treatment or intervention provided by this~     study.~      Subjects will have elevated symptomatology of nonpsychotic chronic or recurrent depressive~     disorder and will be currently receiving or will be prescribed standard of care medication or~     non-medication based treatments by their providers/clinicians. The study cohort will reflect~     the wide range of patients seen in typical primary or psychiatric care settings, and may~     include unipolar or bipolar disorders and dysthymia (a more chronic form of depression). The~     cohort will be broadly representative of and generalizable to the US general population as a~     whole.~   "
49480|NCT02919267|"~     Lung isolation technique and one-lung ventilation (OLV) are the mainstays of thoracic~     anesthesia. Two principal lung isolation techniques are mainly use by clinicians, the double~     lumen tubes (DLT) and the bronchial blockers (BB). The physiology of lung collapse during OLV~     is not well described in the literature. Few publications characterized scant aspects of lung~     collapse, only with the use of DLT and sometime in experimental animals. Two phases of lung~     collapse have been described. The first phase is a quick and partial secondary to the~     intrinsic recoil of the lung. The second phase is the reabsorption of gas contained in the~     alveoli by the capillary bed. The investigators plan to describe the physiology of the second~     phase of lung deflation using of DLT or BB, in a human clinical context.~   "
49481|NCT02919254|"~     The purpose of this study is to examine the effect of varying nitrate doses of beetroot juice~     supplementation on dynamic, multijoint resistance exercise performance in active, trained~     individuals. Performance will be assessed based on parameters including neuromuscular~     efficiency, anaerobic performance capability, oxygen consumption, plasma nitrate/nitrite~     levels, specific muscle tissue biomarkers including lactate, and anthropometric measurements~     of select muscle groups.~   "
49482|NCT02919241|"~     Clinical trial of an application of cognitive behavioural one-session therapy method with~     patients who have severe or average dental fear/anxiety measured by Modified Dental Anxiety~     Scale (MDAS). The intervention consists of two different parts: a diagnostic interview and~     one-session treatment of dental care. The method is based on One-Session Therapy manual (Öst~     & Skaret, 2013). 30 minimum 18 years old adults takes part to the study. They comes from~     three different places,primary care clinic, community dental care and dentist´s teaching~     clinic.~   "
49483|NCT02919228|"~     NOTE: This is the fourth of in total 7 sub-studies related to the Ethics Committee of the~     Canton of Bern Ref. No. KEK-BE 2016-00674. This sub-study includes 50 participants and 8~     arms, in total 350 participants will be assessed in all 7 sub-studies.~      General study information: This is a randomized, cross-over, quantitative study, which~     investigates physiological variables, mood, and affect of healthy participants in response to~     colored light exposure. The Participants take part in 5-8 arms and are exposed to colored~     light only, or are additionally asked to solve cognitive tasks during the colored light~     exposure. Primary aim is to measure the change in several physiological variables, mood, and~     affect during colored light exposure of 15 or 45 minutes. The risk for the participants is~     negligible and comparable to the risk during daily life.~   "
49493|NCT02919098|"~     The investigators have developed a game-based sexual violence prevention program that uses a~     bystander intervention approach. This program is called Bystander and was designed for use~     with high school students in grades 9-12. The goal of this research is to evaluate the~     efficacy and feasibility of Bystander when implemented in a school setting. The research will~     capture data on knowledge about sexual violence and harassment, as well as attitudes,~     self-efficacy, perceived social norms and behavioral intentions around bystander behaviors.~     This research will consist of a baseline survey, program participation, a immediate~     post-program survey, and a 3-month follow up survey with youth participants. It will also~     involve qualitative in-depth interviews with school staff and administration about the~     program.~   "
49534|NCT02918552|"~     This is a randomized double blinded controlled trial of 20-40 mg sodium nitrite tid in~     subjects with HFpEF. Primary outcomes are measures of physical function with non-invasive and~     invasive cardiopulmonary exercise testing, and fatigability, skeletal muscle bioenergetics,~     serology including inflammatory markers and platelet bioenergetics, quality of life measures.~   "
49484|NCT02919215|"~     Teachers are increasingly faced with classrooms of students whose needs require support far~     beyond what traditional teacher-training programs prepare educators to provide. The presence~     of students with greater challenges in classrooms is due in part to the move to a full~     inclusion model of education and also to the rising epidemic of mental health disorders in~     youth. Mental health problems affect up to one million Canadian youth and their families.~     However, few of these individuals (~20%) receive the support they need (Kirby, 2013; Kutcher~     & McLuckie, 2013). The Teacher Help research team along with industry partner, Velsoft, and~     key knowledge user, Nova Scotia Department of Education and Early Childhood Development, will~     address this barrier by developing, evaluating, and commercializing a sustainable eHealth~     resource for teachers. Teacher Help is an online program that assists teachers in providing~     evidence-based interventions to students in grades 1-12 with mental health disorders in the~     classroom. The program allows teachers in a typical classroom setting to access information~     and expert-coach and peer support when they need it, so they can intervene early in order to~     reduce the negative consequences of mental health disorders in youth. Currently three modules~     (Attention-Deficit/Hyperactivity Disorder [ADHD], Autism Spectrum Disorder [ASD], and~     Learning Disabilities [LD]) are at different stages in the innovation pipeline. The~     investigators will test whether teachers make good use of this program and whether it is~     effective in improving mental health outcomes among children and youth both at school and at~     home. The investigators will also study whether the program changes teacher's attitudes~     toward children and youth with these disorders. The investigators will provide information to~     the Department of Education on how to use this program. This approach will help ensure that~     the program will continue after the research study ends. To the Teacher Help team's knowledge~     Teacher Help is the first and only research-validated eHealth program directly targeting~     teachers to help them intervene with children and youth who have mental health disorders,~     thus allowing Canada to take a lead in eHealth as applied to a school context.~   "
49485|NCT02919202|"~     This study compares the efficacy of two dental interventions in the treatment of cervical~     dentine sensitivity. The participants will be selected from adult dental patients registered~     at a general dental practice in West Sussex, UK. The participants will be split into 2~     groups. One group will receive the intervention of topical fluoride varnish application while~     the other group will receive a topical application of self-etching dentine bonding agent.~   "
49486|NCT02919189|"~     NOTE: This is the fifth of in total 7 sub-studies related to the Ethics Committee of the~     Canton of Bern Ref. No. KEK-BE 2016-00674. This sub-study includes 50 participants and 8~     arms, in total 350 participants will be assessed in all 7 sub-studies.~      General study information: This is a randomized, cross-over, quantitative study, which~     investigates physiological variables, mood, and affect of healthy participants in response to~     colored light exposure. The Participants take part in 5-8 arms and are exposed to colored~     light only, or are additionally asked to solve cognitive tasks during the colored light~     exposure. Primary aim is to measure the change in several physiological variables, mood, and~     affect during colored light exposure of 15 or 45 minutes. The risk for the participants is~     negligible and comparable to the risk during daily life.~   "
49487|NCT02919176|"~     This is an open lable, pilot study in which the investigator will research the effect of two~     FDA approved drugs, Mirabegron and Pioglitazone on fat tissue.~      Pioglitazone is drug approved by the FDA for the treatment of diabetes and Mirabegron is a~     drug that is approved by the FDA for the treatment of overactive bladder. These drugs are not~     approved by the FDA for the purposes being studied in this research. Therefore, the way in~     which the investigator intends to use them in this study are considered investigational.~   "
49488|NCT02919163|"~     NOTE: This is the sixth of in total 7 sub-studies related to the Ethics Committee of the~     Canton of Bern Ref. No. KEK-BE 2016-00674. This sub-study includes 50 participants and 8~     arms, in total 350 participants will be assessed in all 7 sub-studies.~      General study information: This is a randomized, cross-over, quantitative study, which~     investigates physiological variables, mood, and affect of healthy participants in response to~     colored light exposure. The Participants take part in 5-8 arms and are exposed to colored~     light only, or are additionally asked to solve cognitive tasks during the colored light~     exposure. Primary aim is to measure the change in several physiological variables, mood, and~     affect during colored light exposure of 15 or 45 minutes. The risk for the participants is~     negligible and comparable to the risk during daily life.~   "
49489|NCT02919150|"~     The aims of this study are:~        -  To examine the inter-rater reliability to assess myofascial trigger points using a~          myotonometer~        -  To determinate the strength of the correlation between myotonometric parameters and~          isokinetic parameters~        -  To evaluate the sensitivity of myotonometric measurements to detect the location of~          myofascial trigger points~   "
49490|NCT02919137|"~     NOTE: This is the seventh of in total 7 sub-studies related to the Ethics Committee of the~     Canton of Bern Ref. No. KEK-BE 2016-00674. This sub-study includes 50 participants and 8~     arms, in total 350 participants will be assessed in all 7 sub-studies.~      General study information: This is a randomized, cross-over, quantitative study, which~     investigates physiological variables, mood, and affect of healthy participants in response to~     colored light exposure. The Participants take part in 5-8 arms and are exposed to colored~     light only, or are additionally asked to solve cognitive tasks during the colored light~     exposure. Primary aim is to measure the change in several physiological variables, mood, and~     affect during colored light exposure of 15 or 45 minutes. The risk for the participants is~     negligible and comparable to the risk during daily life.~   "
49491|NCT02919124|"~     The aim of this study is to evaluate whether use of the echoclip device (an ultrasound~     transducer positioning device which can stabilize the involved part of the myocardium on the~     beating heart) facilitates imaging of coronary bypass anastomoses during coronary bypass~     surgery. A total of 100 low risk patients undergoing elective on-pump coronary bypass surgery~     will be included in the study in order to evaluate if the surgeons can visualize the coronary~     anastomoses before closure of the sternum. Ultrasonograpic pictures will be analyzed directly~     peroperatively and electronically post-operatively in order to evaluate if selected areas of~     the anastomoses can be visualized. Use of the echoclip devise will be considered a success if~     at least 80% of the anastomoses can be visualized.~   "
49492|NCT02919111|"~     The investigators are imaging patients with prostate cancer using a new PET imaging agent~     (Ga-68-PSMA-11) in order to evaluate it's ability to detection prostate cancer in patients~     with high risk disease prior to prostatectomy.~   "
49507|NCT02918903|"~     The objective of this study is to assess and compare the possible post-operative pulpal~     symptoms (Spontaneous pain, pain on percussion, swelling, sinus or fistula), incidence of~     pulp exposure, child acceptance, chair time and radiographic success between two techniques~     for managing dental caries: minimal caries removal and complete caries removal in primary~     molars.~   "
49535|NCT02918539|"~     This registry will be used to identify patients who have etiology diagnosed or suspected to~     be Alzheimer's disease and positive amyloid scans, and have indicated their interest in being~     contacted for an Eli Lilly and Company (Lilly) Alzheimer's Disease drug research trial.~   "
49494|NCT02919085|"~     To analyze changes on respiratory muscle strength, peripheral and functional capacity of~     critically ill patients with clinical and surgical etiology, breathing spontaneously and~     bedridden, within 48 hours of admission to the intensive care unit (ICU) and if there are~     correlations among these variables. This is an observational study. Respiratory muscle~     strength will be assessed through the maximum inspiratory pressure (MIP) and maximal~     expiratory pressure (MEP) and peripheral muscle strength, by the Medical Research Council~     score (MRC) and hand grip test and functional capacity through the Functional Independence~     Measure (FIM) and Physical Function ICU Test Score (PFIT-s) in the period between 24h and 48h~     of hospitalization in the adult ICU. For descriptive purposes, the sample will be stratified~     according to clinical and surgical characteristics. Correlations will be determined using the~     Pearson test, with significance level of p <0.05.~   "
49495|NCT02919072|"~     The study evaluate the quality of epidural anaesthesia and the safety of Chloroprocaine HCl~     3% compared with Ropivacaine HCl 0.75% in patients with an epidural catheter in situ~     undergoing unplanned Caesarean section.~   "
49496|NCT02919059|"~     This superiority of central pressure versus peripheral measures to predict cardiovascular~     events has also been reported in general population or in elder people~   "
49497|NCT02919046|"~     This single-arm, multicenter clinical study will treat the patient who have relapsed or~     refractory neuroblastoma with an infusion of the patient's own T cells that have been~     genetically modified to express a chimeric antigen receptor(CAR)that will bind to tumour~     cells modified to express the GD2 protein on the cell surface. The study will determine if~     these modified T cells help the body's immune system eliminate tumour cells .The trial will~     also study the safety of treatment for CAR-T, how long CAR-T cells stay in the patient's body~     and the impact on this treatment for survival.~   "
49498|NCT02919033|"~     This three arm study is to compare the effects of a coordinated PCP-Cardiologist Telemedicine~     Model (PCTM) with usual care and self-care in community hypertension management in China.~   "
49499|NCT02919020|"~     To evaluate the effectiveness of the method Proprioceptive Neuromuscular Facilitation (PNF)~     as physical therapy approach to the reduction of pain and improvement in functional~     performance and quality of life in women with knee osteoarthritis.~   "
49500|NCT02919007|"~     This is a Usability study, conducted for the purpose of testing Silk'n HST Device usability.~   "
49501|NCT02918994|"~     The purpose of this investigation is to conduct a series of case studies on the impact of~     LearningRx cognitive training on cognitive skills, brain structure, and daily functioning for~     participants with Traumatic Brain Injury (TBI).~   "
49502|NCT02918981|"~     Using stable isotope methodology, investigators will determine the postabsorptive and~     postprandial muscle protein synthetic response in 60 female adults (Age 50-79, BMI: <30~     kg/m2) immediately after an acute bout of resistance exercise. Participants will be divided~     in to 5 groups of twelve women (n=12). Each group will receive a different protein beverage~     or placebo to consume following the resistance exercise training. Group 1 will consume a~     beverage consisting of whey protein; group 2 will consume whey protein supplemented with~     additional leucine; group 3 will consume whey protein supplemented with additional leucine~     and hydrolyzed whey peptides; group 4 will consume whey protein supplemented with additional~     leucine and citrulline; group 5 will just consume water. During the testing, blood and muscle~     samples will be collected.~   "
49503|NCT02918968|"~     The objective of this study is to compare the efficacy and safety of the combination therapy~     with enzalutamide + androgen deprivation therapy (ADT) and the combination therapy with~     flutamide + ADT in patients with castration resistant prostate cancer who have relapsed~     during combined androgen blockade (CAB) therapy with bicalutamide and ADT. This study will~     also investigate the order of alternative antiandrogen therapy (AAT) by changing the 1st line~     medication after relapse of prostate-specific antigen (PSA).~   "
49504|NCT02918955|"~     Treatment of regionally-advanced head and neck squamous cell carcinoma (HNSCC) requires a~     multidisciplinary approach with a combination of surgery, radiotherapy (RT) and chemotherapy.~     Due to these aggressive combined modalities, patients undergoing treatment and many survivors~     develop toxicities which impact quality of life (QoL) and sometimes lead to mortality.~      Lymph node metastases of HNSCC are frequent and considered one of the most important~     prognostic factors, resulting in decreased survival by 50%. More than three decades, the~     optimal management strategy of node positive HNSCC was a key subject of debate. In summary,~     the current literature provides us two important findings: First, with the contemporary~     imaging and treatment modalities, there is no role of a planned neck dissection (ND) added to~     (chemo)radiotherapy ((C)RT) in terms of oncological outcome and survival. Second, with modern~     RT techniques, a tailored treatment followed after an up-front neck dissection (UFND) allows~     a significant reduction of treatment volumes and de-escalation of the dose to the neck,~     leading to reduction of treatment related toxicities.~      In this study strategies with and without up-front neck dissection prior to~     chemo-radiotherapy will be compared.~   "
49505|NCT02918929|"~     This randomized, double-blind, placebo-controlled study will assess the safety, tolerability,~     and pharmacokinetics of single and multiple orally administered doses of EDP-305 in healthy~     adult subjects, and adult subjects with presumptive NAFLD (i.e., obese subjects with or~     without prediabetes or T2DM).~   "
49506|NCT02918916|"~     Introduction: Recent studies have shown positive results from the application of phototherapy~     for the improvement of performance and acceleration of the recovery process both in the~     application before and after exercise. However, the effects of phototherapy during combined~     training and after a primary adaptation process remain unclear.~      Research objectives: The primary objective of the study is to analyze and compare the effects~     of phototherapy using different light sources (laser and light emmiting diode - LED)~     interacting with combined training on clinical, functional, and psychological outcomes and~     vascular endothelial growth factor. The secondary objective is to compare the benefits~     provided by phototherapy in participants with different levels of training adaptation.~      Design: A controlled trial, double-blind, placebo-controlled will be conducted with~     stratified randomization and concealed allocation.~      Participants and Setting: After fulfilling the eligibility criteria, forty-five male~     participants will participate in the study.~      Procedure: In phase 1, the participants will perform six-weeks of combined training (sprints~     and squats). In phase 2, participants will be allocated, through stratified randomization~     (based on adaptation capacity to training), into three groups: active phototherapy group~     (AG), placebo phototherapy group (PG), and control group (CG). A new six-week training period~     will then start. In this phase the participants will carry out training normally with the~     adjusted loads and between sprints and squats will receive the recovery strategy related to~     the group to which they belong.~      Intervention: Active and placebo phototherapy will be applied by a trained therapist, between~     sprints and squats. During the period of recovery strategies for the AG and PG, the CG~     participants will remain seated for passive recovery, supervised by an independent therapist.~      Measurements: The measurements include clinical, functional, and psychological outcomes and~     vascular endothelial growth factor.~   "
49508|NCT02918890|"~     A randomized control trial examining the relationship between changes in hand function and~     brain plasticity following intensive therapy. Two treatment approaches are used:~     constraint-induced movement therapy (CIMT) or Hand-Arm Bimanual Intensive Therapy (HABIT).~     The protocols have been developed at TC Columbia University to be child friendly and draw~     upon our extensive experience with constraint-induced movement therapy in children with~     cerebral palsy. Our center has been providing interventions camps for children with cerebral~     palsy since 1998. The interventions are performed in a 15 day day-camp setting with several~     children and at least one interventionist per child. The aim of the intervention is to~     improve the use of the affected hand and quality of overall movement in a fun, social~     setting. PARTICIPATION IS FREE. Please check out our website for more information:~     http://www.tc.edu/centers/cit/~   "
49509|NCT02918877|"~     The purpose of this study is to investigate whether the use of inhaled anesthetics, compared~     to intravenous anesthetics, can affect the amount of lung inflammation and postoperative~     respiratory complications seen after cardiac surgery.~   "
49510|NCT02918864|"~     The purpose of this study is to evaluate the feasibility, safety, and preliminary efficacy of~     integrating targeted dosing of intranasal oxytocin with a social cognitive skills group~     therapy for school-aged children with autism spectrum disorder (ASD).~   "
49511|NCT02918851|"~     This is a single-center, randomized, partially blinded study to determine whether 42-day old~     red blood cells (RBCs) deliver oxygen as effectively as 7-day old RBCs and also to determine~     whether transfusion with 28-day old RBCs is non-inferior to 7-day old RBCs with respect to~     oxygen delivery.~      In this study, subjects will be randomized to be transfused with 2 units of autologous (one's~     own) RBCs that are either 7-, 28-, or 42-days old. Endpoints include changes in exercise~     duration and VO2 max (test of oxygen consumption/delivery) between groups.~   "
49512|NCT02918838|"~     This study is an extension of Reminding Adolescents to Adhere (RATA) (Unique protocol ID:~     1R01HD074925-01). Participants for SATA will be recruited during the RATA month 24 exit~     survey.~      Participants will be randomized 1:1:1 into either one of two intervention group (receiving~     the weekly messages and a chance to draw a prize at each clinic visit based on either a fixed~     adherence level of 90% or a self-chosen one of at least 80% as further detailed below) or the~     control group that receives the existing RATA intervention consisting of weekly motivational~     messages and the chance to get mobile airtime rewards conditional on responding. Doing so~     will allow the investigators to cleanly evaluate the impact of these additional~     adherence-based lotteries, and guarantees that those who have been in the control group~     receiving standard of care in the first 24 months of the RATA intervention will also receive~     an intervention for reasons of fairness.~   "
49513|NCT02918825|"~     A randomized trial of olanzapine and Long-acting paliperidone palmitate injection in the~     treatment of 100 treatment- naive first-episode patients with schizophrenia.~   "
49514|NCT02918812|"~     This study compares the effect of intracervical block with 1% lidocaine and intramuscular~     diclofenac 75mg in decreasing pain perception during hysterosalpingography. Half of~     participants will receive intracervical block with 1% lidocaine, while the other half will~     receive intramuscular diclofenac 75mg.~   "
49515|NCT02918799|"~     This project will adapt and pilot a multi-level, community-based intervention to promote HIV~     prevention and sexual health among young men who have sex with men in Beirut.~   "
49516|NCT02918786|"~     The purpose of this study is to compare the effect of continuous positive airway pressure~     (CPAP) delivered by the variable generator WhisperFlow System with high flow nasal cannula~     oxygen therapy in mechanically ventilated patient who are at risk for postextubation failure.~   "
49517|NCT02918773|"~     Acute otitis media (AOM), defined as acute inflammation in the middle ear, is a leading cause~     of health encounters and antimicrobial prescriptions in children worldwide. Diagnosis of AOM~     is often dependent on a brief view of the tympanic membrane in an uncooperative child's ear~     canal. As a consequence, AOM may be inappropriately diagnosed when visualization of the~     tympanic membrane (ear drum) is not optimal. Improved methods for visualizing the tympanic~     membrane including capturing still images and recording video of the ear exam would be~     beneficial in the diagnosis and management of otic complaints, including acute and chronic~     otitis media. Use of a smartphone otoscope has the potential to optimize clinician ability to~     manage otic complaints, visualize the tympanic membrane, and support antimicrobial~     stewardship. This study will be conducted as a randomized control study in two affiliated~     children's hospital emergency departments. Twenty volunteer clinicians will be randomly~     assigned to use either a smartphone otoscope or a conventional otoscope for all otic~     examinations for a 6-month period.~   "
49518|NCT02918760|"~     Aim :The aim of this study is to evaluate the efficacy of oral Gabapentin in the treatment of~     chronic pelvic pain in females.~      The study is designed as a randomised, placebo-controlled, clinical trial.32 patients will be~     enrolled each arm.~      Group A (cases):~      This group will include (32) women according to inclusion and exclusion criteria and will~     receive a card of Gabapentin which will be taken orally by the patient at home three times~     daily and maximum dose 2700mg per day by 300 mg increments each week until sufficient pain~     relief, or the occurrence of side effects such as dizziness, somnolence, edema and ataxia.~     Group B (controls):This group will include (32) women .~      Assessment of the patient's pain during the physical examination will be done using the~     Visual Analogue Scale (VAS). The patient will be asked to place a mark on a drawn 10 cm line~     at a point which is corresponding to the intensity of her pain. One end of the line denotes~     no pain and the other end of the line indicates that pain is as bad as it can be (the worst~     pain).the distance in cm from the low end of VAS to the patient's mark will be used (it gives~     a number.Questionnaire: will be given to all participants at randomization (0 months) , at 3~     months and at 6 months to assess the degree of pain improvement via VAS.~      Patients' overall satisfaction with their pain treatment &Side effect recording (e.g.,~     dizziness, somnolence, mood changes, appetite and poor concentration).~   "
49519|NCT02918747|"~     Extranodal natural killer/T-cell lymphoma (ENKTL) is an aggressive subtype of non-Hodgkin's~     lymphoma and shows extremely poor survival. Several retrospective studies and singe-arm~     prospective phase 2 studies have shown that pegaspargase combined Gemox or CHOP regimen~     achieved a promising efficacy in treatment of ENKTL. However, there is no prospective study~     to compare the efficacy of these two regimens. This prospective pilot study to compare the~     efficacy and safety of the P-Gemoxd chemotherapy regimen with those of the P-CHOP regimen for~     stage IE to IIE ENKTL.~   "
49520|NCT02918734|"~     In this randomized controlled trial the investigators will compare the results after primary~     anterior cruciate ligament (ACL) reconstruction using two different methods for femoral~     fixation of a bone-patellar tendon-bone (BPTB) autograft. Interference screws have been the~     standard method for fixing the femoral side of BPTB grafts; however, several pitfalls have~     been reported. Cortical fixation with the Endobutton CL BTB Fixation System has become~     available and the clinical results have been described as promising; however, no randomized~     controlled trials comparing these two femoral fixation methods have been conducted, and there~     is no published data that confirms that the bone block heals in the tunnel with the newer~     method.~      The aim of our study is to compare the outcome after primary ACL reconstruction with BPTB~     autografts using the Endobutton CL BTB or metal interference screw for femoral fixation.~   "
49521|NCT02918721|"~     The purpose of this study is to evaluate the pain and safety associated with injections of~     Restylane Lidocaine compared to Restylane using a visual analogue scale.~   "
49522|NCT02918708|"~     The National Vaccine Evaluation Consortium conducts Department of Health funded trials trials~     to provide information to underpin changes to the national immunisation and vaccination~     schedule.~      This study will assess how different schedules of pneumococcal conjugate vaccines work in~     providing protection to young infants. It is well established that vaccines can behave~     differently depending on which order they are given and alongside which other immunisations.~     This has been shown for Hib and MenC vaccines, which are similar in structure to the~     pneumococcal vaccines that will be studied here. The investigators will measure responses to~     the pneumococcal vaccines as well as to other routine immunisations, all of which will be~     provided by our study team. Infants will be recruited by dedicated study staff through~     primary care and will participate from their first vaccinations at 2 months of age, until the~     blood sample taken a month after their boosters at a year old, i.e. until 13 months of age.~      Any child found to have antibody levels below that which indicates protection for Hib, MenC,~     MenB or pneumococcal in the blood sample taken at 13 months of age will be offered an extra~     dose of the relevant vaccine(s).~   "
49523|NCT02918695|"~     The purpose of this study is to compare clinical judgment and comprehensive geriatric~     assessment as screening tools for optimization of treatment for newly diagnosed elderly~     multiple myeloma patients.~   "
49524|NCT02918682|"~     This study evaluates if a multi-component intervention, respecting the characteristics of~     frail older person and increasing intensity and challenge of exercises according to frail~     older person capacity/evolution will induce better functional results than a multi-component~     intervention specific to lower body. the volunteers will be randomized into experimental~     group and control group.~   "
49525|NCT02918669|"~     Examine the long-term survivorship via CT Scan of the coflex in patients who presented with~     spinous process fracture(s) at 24 months in the Paradigm Spine coflex IDE Study.~   "
49526|NCT02918656|"~     The objective of the investigators study is to evaluate the efficacy of infographics in~     presenting information, in terms of understanding and remembering research results, compared~     to standard PLS formats and scientific summary formats (SciSum).~   "
49527|NCT02918643|"~     Objective: To develop and evaluate the effectiveness of a mobile application to support~     decision making for prescription drugs to elderly patients. Method: Firstly, there will be a~     two-tier content validation of potentially inappropriate medicines (PIM) for the elderly~     based on Beers Criteria and STOPP. For the validation, a modified Delphi consensus technique~     will be applied. Twelve national experts will be invited. For each statement contained in the~     Beers criteria and STOPP a proposition will be prepared in order to allow each participant to~     issue an opinion on each of the propositions by assigning a value according to their~     agreement to the statement. Therefore, the Likert scale with established score of 1 to 5~     (completely disagree - strongly agree) will be used. Statements with average scores above 4.0~     will be considered consensus. All information regarding PIMs will be made available through~     an application for tablets. The information on risks and recommendations about the drugs will~     be available whenever the users enter the medicines name. The application will be developed~     for the Android platform, which is based on the Java programming language. To evaluate the~     use of this application 30 doctors working in basic health units and health units of the~     family in a municipality from Bahia will be asked to join the study. Upon acceptance, the~     proportion of PIMs' prescription by these professionals for a minimum period of two months~     will be analyzed. Later, 15 doctors will be randomized into the intervention group and will~     receive a tablet with the application installed. They will be trained to use it as well as to~     access to the Evidence Based Health Portal of the Ministry of Health. The control group of 15~     other physicians will receive the tablet and will be trained to access the Evidence Based~     Health Portal. The study will be blind to the participants and to the main investigator. To~     continue, the information will be analyzed by sampling the PIMs' prescription in both groups.~     To access this information the prescriptions' duplicate original, filed in pharmacies,~     patient files or home visit will be required. The PIMs prescription ratios before and after~     the intervention will be compared.~   "
49528|NCT02918630|"~     The purpose of this study is to assess if access to an electronic nicotine delivery device,~     or e-cigarette, in addition to nicotine patch (21 mg) can help reduce cigarette smoking among~     individuals diagnosed with schizophrenia compared to nicotine patch alone.~   "
49529|NCT02918617|"~     This study will investigate the effectiveness of nanohydroxyapatite (nano-HAP)-containing~     toothpastes and cream to relieve dentin hypersensitivity, comparing it with those of a~     commercial desensitizing dentifrice containing calcium sodium phosphosilicate (Novamin®~     technology) and a standard fluoride dentifrice containing 1,500 ppm fluoride as sodium~     monofluorophosphate (MFP).~   "
49530|NCT02918604|"~     multicenter, prospective and cohort study to evaluate infrared technology for identifying and~     and indwelling peripheral veins in 0 up to 4 years old children.~   "
49531|NCT02918591|"~     It has been shown that in patients with type 2 diabetes (T2D) at high risk for cardiovascular~     disease (CVD) who received Empagliflozine as compared with placebo had a lower rate of death~     from cardiovascular causes, non-fatal MI, or non-fatal strokes as well as death from any~     cause and hospitalization for heart failure.~      This lower incidence of cardiovascular disease in individuals treated with selective~     inhibitor of renal sodium-glucose co-transporters (SGLTs) has been associated with reduction~     of blood levels of fibroblast growth factor 23 (FGF23) and with increase of blood levels of~     Klotho.~      Therefore we will investigate the blood levels of fibroblast growth factor 23 (FGF23) and of~     Klotho in type 2 diabetic patients treated with Empagliflozine The investigators anticipate~     that patients treated with Empagliflozine will have decreased levels of FGF23 and increased~     levels of Klotho which would provide a good explanation for the beneficial cardiovascular~     effects of selective inhibitors of renal sodium-glucose co-transporters (SGLTs)~   "
49532|NCT02918578|"~     The purpose of this study is to compare different modalities to communicate a remote and~     individually tailored physical activity promotion program.~   "
49536|NCT02918526|"~     The purpose of the study will be to record the hemodynamic response measured by traditional~     methods (non-invasive blood pressure and ECG) and Pressure Recording Analytical Method in~     patients undergoing laryngeal mask placement compared with the hemodynamic response measured~     in patients undergoing laryngoscopy and tracheal intubation for performing surgery in~     gynecological area and assess the differences with the two methods.~   "
49537|NCT02918513|"~     The purpose of this study is to explore the efficacy and feasibility of an integrated,~     prescriptive, and trackable wellness intervention combining five wellness elements including~     exercise, mindfulness, sleep, social connectedness, and nutrition.~   "
49538|NCT02918500|"~     This study will determine whether or not patients who use a Nicotine Replacement Therapy~     (NRT) patch prior to their by-pass surgery are more likely to be smoke-free 6 months after~     their surgery and have fewer post-operative complications~   "
49539|NCT02918487|"~     The aim of this trial is to study the effect of a polyherbal capsule containing four herbs:~     Inula racemosa, Ocimum sanctum, Terminalia Belerica and Piperum longum in the treatment of~     bronchial asthma.~   "
49540|NCT02918474|"~     An online decision support tool will be field tested that provides patients facing a decision~     about contralateral prophylactic breast cancer (CPM) with evidence-based information about~     the expected incidence of contralateral breast cancer and the life expectancy benefit of CPM.~     The tool will be designed for use in clinical settings and viewed jointly by the patient and~     physician as part of a shared decision making process around CPM.~   "
49541|NCT02918461|"~     At Cedars-Sinai Medical Center, the investigators have developed a novel curriculum for a~     6-week psycho-educationally-based, cognitive behavioral program to help patients with~     subjective cognitive complaints after cancer treatment, titled Emerging from the Haze™~     (Haze). Each series meets once a week for 2-2.5 hours for 6 weeks.~      The objective of this study is to quantify the impact of a trainee-taught Emerging from the~     Haze course on gynecologic cancer survivors' self-report of cognitive changes based on the~     change of FACT-Cog score.~   "
49542|NCT02918448|"~     Metabolic syndrome (MetS) is a multicomponent disorder closely linked to low grade~     inflammation, and cardiovascular disease (CVD). The aim of this study was to investigate the~     effects of a 12-week resistance training (RT) program on body composition, risk factors for~     metabolic syndrome (MetS), and inflammatory biomarkers in older adult women~   "
49543|NCT02918435|"~     This research project is aimed to assess the implementation, effectiveness, and~     sustainability of a pediatric-based intervention aimed at reducing families' unmet material~     needs (food, housing, employment, childcare, household heat, education) in pediatric~     practices throughout the United States.~   "
49544|NCT02918422|"~     To determine the effects of high cheese diets varying in carbohydrate content on markers of~     disease risk.~   "
49545|NCT02918409|"~     The purpose of this study is to find the safest and most effective way to administer IV~     antibiotics to treat acute pulmonary exacerbations (APEs) in patients with cystic fibrosis~     (CF) that are caused by pathogens, like Pseudomonas aeruginosa. This study will test the~     safety and effectiveness of two commonly prescribed IV antibiotics: tobramycin and colistin.~     Though regularly used, not much is known about how these drugs compare with each other in~     terms of their toxicities, both during short term treatment of an APE and after many~     treatment courses with these drugs over many years. There are currently no guidelines on the~     safest and most effective antibiotics to use when treating APEs. We will study kidney~     function, sputum cultures, and treatment outcomes in patients receiving routine~     administration of one of these two IV antibiotics. We will also test these outcomes in~     patients receiving a less frequent dosing schedule for IV colistin. The hope is that this new~     schedule for IV colistin, which is twice a day and adjusted based on blood and urine tests,~     will reduce harmful side effects, such as kidney damage, while still being a powerful~     treatment against CF microbial pathogens.~   "
49546|NCT02918396|"~     Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia with increasing~     morbidity and mortality. A catheter-based AF ablation technique that isolates pulmonary veins~     (PV) from the left atrium has been established to disrupt AF. Despite significant~     development, AF ablation with pulmonary vein isolation (PVI) is reported to have a success~     rate of 40-80% in various AF populations.~      Persistent AF appears to be more reliant upon fibroblast proliferation and myocyte-fibroblast~     coupling than paroxysmal AF with obvious implications on its management. Despite the~     knowledge that fibrotic substrate is responsible for the perpetuation of persistent AF,~     several ablation techniques targeting these extra-pulmonary veins sites have failed to prove~     an additional benefit to PVI alone. Nevertheless, two recently developed technologies, aimed~     at detecting AF substrate with high precision, seem to constitute a potential breakthrough in~     the management of persistent AF. On one hand, late gadolinium-enhanced MRI (LGE-MRI) is a~     well-established method to identify fibrosis in the myocardium. Recent reports from a single~     center have shown that MRI-based left atrial fibrosis detection is able to predict the~     outcome of the procedure. Hence, targeting lesions seen on LGE-MRI in the setting of~     persistent AF is an option yet to be explored and compared to the widely adopted, yet~     suboptimal, PVI. On another hand, a novel ablation method with promising results is focal~     impulse and rotor modulation (FIRM). Undergoing wide sampling of the atria with~     spatiotemporal and computational mapping while in AF has identified areas with stable~     organized rotational electrical activity (rotors). Several studies are under way to prove the~     reproducibility of rotor mapping, with more groups reporting improved rates of acute and~     long-term suppression of AF with ablation of FIRM-identified rotors.~      The SIMPle AF study will be a randomized clinical trial designed to test the hypothesis that~     ablation tailored to the underlying substrate using either LGE-detected dense scar or rotor~     anchor sites predicted by computational modeling is superior to anatomic non-tailored PVI~     ablation in patients with persistent AF. For the present study, the investigators plan to~     enroll a total of 30 patients.~   "
49547|NCT02918383|"~     Laser Angiography using indocyanin green (ICG) is a relatively new technique and has been~     utilized to assess the viability of soft tissue, most prominently in the general surgery and~     plastic surgery literature. This technique has been used for prediction of soft tissue~     viability by assessing the perfusion status. There is currently no Orthopaedic literature~     regarding the use of this device for assessment of subchondral perfusion of articular~     surfaces such as the distal femur or other chondral surfaces.~      In this pilot study, the use of ICG to detect the perfusion status of a distal femur and~     proximal tibia during a surgical approach to the knee and correlating this to visible signs~     of arthritis. For example, due to the difference visible with ICG angiography correlate to~     gross changes in the cartilage health visible to the naked eye with radiographic imaging.~   "
49591|NCT02917811|"~     The aim of this study is to verify if high values of RDW are useful prognostic marker for ICU~     mortality and 90-days mortality. Moreover, we will investigate the prognostic value of RDW in~     specific subgroup population with some clinical characteristic wich may modify RDW baseline~     values, i.e. transfused patients or patients with high markers of hemolysis~   "
49548|NCT02918370|"~     The investigators will conduct a 12-week, randomized, double-blind, parallel-group,~     placebo-controlled study of aripiprazole in 132 persons with Alcohol Use Disorder (AUD) and~     bipolar I or II disorder, currently depressed or mixed phase. Primary Aim will be to assess~     change in alcohol use by the Timeline Followback (TLFB) method. Secondary Aim will include~     change in alcohol craving using the Penn Alcohol Craving Scale (PACS). Changes in psychiatric~     symptoms (mania/hypomania and depression) and predictors of response will be assessed.~     Participants with ≥ 1 drinking day at week 12 will be enrolled in a 4-week extension phase~     with an upward titration to 30 mg/day for those in the active treatment group. The placebo~     group will remain on placebo.~      Subjects will be discontinued from the study if any of the following conditions occurs:~     change in diagnosis to other than bipolar I or II disorder and AUD, development of active~     suicidal or homicidal ideation with plan and intent, worsening in mood symptoms, that in the~     opinion of the investigators requires discontinuation, pregnancy, development of severe or~     life-threatening medical condition, involuntary psychiatric hospitalization or incarceration,~     significant alcohol withdrawal (e.g. delirium tremens) based on clinical judgment (increases~     in Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) scores will initiate a~     careful clinical assessment of possible worsening of withdrawal symptoms), or cocaine or~     amphetamine-positive urine drug screen during the study.~   "
49549|NCT02918357|"~     The investigators are imaging patients with prostate cancer using a new PET imaging agent~     (Ga-68-PSMA-11) in order to evaluate it's ability to detection prostate cancer in patients~     with biochemical recurrence after prostatectomy and radiation therapy.~   "
49550|NCT02918344|"~     The goal of this study is to determine if the use of calcium phosphate paste in mandibular~     lengthening surgery causes more complications as surgical site infections and hardware~     removal.~      An evaluation will be made to determine if the benefits of the use of the paste~     (3D-stability, prevention of early relapse and unaesthetic indentation) outweighs the~     disadvantages.~   "
49551|NCT02918331|"~     The purpose of this study is to evaluate the safety of daratumumab when combined with~     lenalidomide and dexamethasone in Japanese participants with newly diagnosed multiple myeloma~     who are not candidates for high-dose chemotherapy and autologous stem cell transplantation~     (ASCT).~   "
49552|NCT02918318|"~     The purpose of this study is to evaluate the efficacy of fixed dosed intranasal esketamine~     compared to intranasal placebo, as an add-on to an oral antidepressant in Japanese~     participants with treatment-resistant depression (TRD), in improving depressive symptoms.~   "
49553|NCT02918305|"~     The REQUIRE STUDY is a multi-center, randomized, double-blind, sham-controlled study, which~     aims to confirm the efficacy and safety of PRDS-001 (ReCor Medical Inc. Paradise® in Europe)~     for renal denervation therapy in patients with treatment resistance hypertension, in~     comparison with the sham procedure.~   "
49554|NCT02918292|"~     This study is a prospective, simultaneous, parallel phase II study with one arm receiving~     unrelated cord blood transplantation and the other arm receiving haploidentical~     transplantation for Severe Aplastic Anemia (SAA) patients. The primary objective is to assess~     overall survival (OS) separately in the 2 arms at 1 year post-hematopoietic stem cell~     transplantation (HSCT).~   "
49555|NCT02918279|"~     This trial is conducted globally. The aim of this trial is to investigate the effect of~     liraglutide for weight management in pubertal adolescent subjects with obesity.~   "
49556|NCT02918266|"~     The purpose of this study is to assess the effect of a single oral dose of TAK-071 on the~     attenuation of cognitive deficit induced by scopolamine as measured by Groton Maze Learning~     Test (GMLT) (total number of errors).~   "
49557|NCT02918253|"~     Brachytherapy as a monotherapy treatment is highly effective for localized prostate cancer,~     traditionally being delivered to the whole prostate gland. Lately, low dose rate (LDR)~     brachytherapy has been increasingly replaced by high dose rate (HDR) brachytherapy treatment~     schemes. While brachytherapy's oncologic outcomes are excellent, it is not without incidence~     adverse effects including urinary, rectal, and sexual toxicities that affect the patient's~     quality of life.~      This study will incorporate HDR monotherapy treatment option for early stages and favourable~     risk prostate cancer.~      Additionally, we aim to evaluate the role of focal HDR brachytherapy for well-defined disease~     based on multiparametric MRI (mpMRI). This approach may offer an option of reducing the~     treatment toxicities while maintaining oncologic outcomes when compared with whole-gland~     therapy. Advantages in quality of life could be exhibited in the form of reduced urinary~     discomfort and incontinence, rectal symptoms, and improved erectile and prostatic gland~     function. This study would be particularly relevant in the current era of earlier localized~     prostate cancer detection, where newer imaging modalities (e.g. mpMRI) become a routine~     component of patient care.~   "
49558|NCT02918240|"~     Fixed orthodontic braces are routinely used to straighten teeth and correct the bite of~     individuals. Once the braces are fit, the patient is recalled every few weeks to adjust or~     tighten the brace. Although convention states that the patient returns every 6-8 weeks to~     have the brace adjusted, there is no consensus or evidence to support a specific timeframe.~     Indeed some orthodontist see their patients as frequently as every 4 weeks and others as long~     as every 10 weeks. The aim of this investigation is to determine whether the amount of time~     between brace adjustment appointments has an effect on the overall treatment time. Knowing~     which appointment interval will lead to the shortest overall treatment time will be of~     benefit to patients as prolonged orthodontic treatment may be associated with an increased~     incidence of adverse effects associated with orthodontic treatment.~      Patients who are to be treated with fixed orthodontic braces at will be invited to take part~     in the study. Consenting subjects will be randomly allocated into one of four groups. The~     first will be seen to adjust their brace every 4 weeks, the second group every 6 weeks, the~     third group every 8 weeks and the fourth group every 10 weeks.~      The primary outcome measure is the total treatment time. The mean treatment time of each of~     the four groups will be compared to establish whether or not treatment appointment intervals~     affects treatment time.~      Secondary outcome measures will include difference in number of appointments required~     throughout the course of treatment between groups, differences in treatment outcomes,~     differences in patient compliance.~   "
49559|NCT02918227|"~     Every year in France, more than 60 000 people are operated for benign prostatic hyperplasia~     (BPH). This surgery is accompanied by a change or even a loss of ejaculations externalized~     what constitutes the main constraint for patients. Empirically, the investigators talk to the~     patient retrograde ejaculation to explain a possible loss of ejaculation. Yet the~     underlying mechanism of this modification or loss of ejaculation remains completely unknown.~     Yet the underlying mechanism of this modification or loss of ejaculation remains completely~     unknown. No study could not determine whether the predominant mechanism was a real retrograde~     ejaculation or aspermia. Moreover, technical changes are sometimes tempted to preserve~     antegrade ejaculation but no scientific rationale can not validate.~   "
49560|NCT02918214|"~     Sepsis induces a reversible systolic and diastolic cardiac dysfunction. The presence of a~     left ventricular (LV) diastolic dysfunction during septic shock could favor harmful volume~     overload. Recently, a meta-analysis suggested a negative prognostic role of LV diastolic~     dysfunction in septic patients (Od Ratio: 1.82; 95%CI: 1.12 - 2.97; p = 0.02) but its~     external validity is hampered by the numerous limits and the heterogeneity of the studies. To~     date, a pathophysiological link between LV diastolic dysfunction associated with septic shock~     and the water balance (reflecting volume overload) remains to establish. In addition, small~     size studies reported an excess of mortality in patients with septic shock who were diagnosed~     with a high cardiac output. However, no large cohort has yet confirmed the negative~     prognostic role of a hyperkinetic hemodynamic profile at the initial phase of septic shock.~   "
49561|NCT02918201|"~     After surgical procedures, interventions to reduce postoperative bleeding are of great~     importance. In this study, the effect will be investigated of administering tranexamic acid,~     which is designed for injection, directly onto the raw wound surface (topical application)~     created during surgery. In this way only a small amount of drug is to reach a large wound~     area. There will be a higher drug concentration of it in the exposed wound surface than after~     injection, but only a very low concentration in the body, and no risk of injury from needles.~     The researchers have recently shown that topically applicated tranexamic acid reduces~     bleeding in women who had two-sided breast reduction surgery. Now it will be studied whether~     topically applicated tranexamic acid reduces bleeding and wound effusions from superficial~     wounds, using as a study model the homogenous wounds created by tangential skin excision when~     harvesting split skin grafts for skin transplants. Two identical wound surfaces in the same~     patient will serve as case and control.~   "
49562|NCT02918188|"~     This study suggested that hydrogen has a potential as an effective and safe therapeutic agent~     on cGVHD.~   "
49563|NCT02918175|"~     The overall objective of this study is to test a personalized mHealth intervention designed~     to increase physical activity and improve medication adherence in subjects with heart failure~     and diabetes mellitus. The study will leverage consumer technology as both an intervention~     and as a tool for data collection.~   "
49564|NCT02918162|"~     This is a non-randomized, multi-site, open-label trial of pembrolizumab and chemotherapy in~     subjects with gastric or gastroesophageal (GE) junction adenocarcinoma. The purpose of this~     study is to determine and evaluate the efficacy of combination therapy with immune checkpoint~     blockade and chemotherapy used in the perioperative period in eradicating micrometastatic~     disease; and to compare paired tissue and serum samples (pre-treatment and post-treatment)~     from individually treated patients to explore the immune effects of combination therapy and~     predictors of response.~   "
49565|NCT02918149|"~     Clinicians are often unable to successfully do a spinal tap. Ultrasound has been proposed as~     a method to improve success but it is not known if it helps. This study is designed to see if~     ultrasound improves the success rate.~   "
49566|NCT02918136|"~     This is a prospective, randomized, multi-site, safety and efficacy study in subjects with~     rotator cuff injuries.~      Patients will fall into two categories: treatment group (12 subjects) and non-treatment or~     control group (six subjects). The treatment group will undergo a small liposuction procedure~     and receive rotator cuff repair treatment with an ultrasound-guided injection of 5cc~     adipose-derived stem cells (ADSCs) into the point of injury. The control group will receive a~     5cc cortisone injection into the point of injury~   "
49567|NCT02918123|"~     Phase I clinical trial to evaluate safety of FURESTEM-CD Inj. in patients with moderate to~     severe in plaque-type psoriasis injection for 4weeks.~   "
49568|NCT02918110|"~     The study will compare orally administrated solution of Misoprostol (Cytotec®) with vaginal~     slow release (7ug/h) Misoprostol (Misodel®) regarding efficacy and safety during labour.~   "
49569|NCT02918097|"~     To evaluate the effectiveness of an algorithm for Bipolar Disorder depressive episodes (BDD)~     using medications available in the Brazilian Public Healthcare System (SUS). Quality of life~     assessment of these patients was also employed.~      A randomized pragmatic trial was conducted. An algorithm was developed for the treatment of~     episodes of bipolar disorder depression episodes.~   "
49570|NCT02918084|"~     Breast cancer is the most common form of cancer among women. For patients candidated for~     adjuvant chemotherapy and endocrine therapy the optimal timing for their has not been clearly~     defined yet.~   "
49571|NCT02918071|"~     The purpose of the study is to assess functionality, performance, and reliability of an~     single-use auto-injector (AI) with benralizumab administered subcutaneously (SC) in an~     at-home setting reported by the patient or caregiver, and to confirm the safety and clinical~     benefit of benralizumab administration in asthma patients with severe asthma~   "
49592|NCT02917798|"~     This study will evaluate patients' experiences with having gynecologic or prostate medical~     oncologists and surgeons offer them genetic testing, and having genetic counselors return the~     test results to patients over the telephone. This is different from the usual approach to~     genetic testing, where gynecologic or prostate medical oncologists and surgeons refer their~     patients to a genetic counselor in order to have these tests done, and the genetic counselors~     return the test results to the patient in person or over the telephone. The investigators~     will only be evaluating this alternative way of providing genetic testing to ovarian or~     prostate cancer patients.~   "
49593|NCT02917785|"~     the purpose of this study is to examine the success rates of Karman curettage in completing~     the abortion after failed recurred treatment with Misoprostol for women with missed abortion.~   "
49572|NCT02918058|"~     Potentially inappropriate medications (PIMs) can lead to adverse drug events (ADEs) among~     older adults and especially those classified as frail. ADEs are responsible for nearly 27,000~     hospital admissions in Canada annually. Within 30 days of discharge, medications contribute~     to two-thirds of adverse events, with nearly 60% being preventable or ameliorable. MedSafer~     is software product that guides patients and physicians in the community through the process~     of deprescribing. MedSafer electronically cross-references patient comorbidities with the~     most recent evidence-based PIMs, as of the study date, in order to generate a~     patient-tailored deprescribing care plan. This study will evaluate whether this application,~     when applied at hospitalization, leads to a reduction in the proprotion of patients with PIMs~     prescribed at discharge, by highlighting harmful medications for deprescription to treating~     physicians. This study will take place on the clinical teaching units (CTUs) at four~     hospitals. Based on historical records, the investigators estimate enrolling 480 patients~     aged 65 or older over three months. A trained research assistant will identify eligible~     patients, and will enter their medications, comorbidities, and an estimate of frailty into~     MedSafer. A deprescribing plan will be generated for the CTU team containing rationale for~     suggested medication changes and strategies for safe and successful deprescription. The CTU~     team will then decide in conjunction with the patient or proxy, and with relevant~     consultants, which medications can rationally be stopped or tapered at discharge.~   "
49573|NCT02918045|"~     The purpose of this study is to compare two hemostatic agents in patients under dual~     antiplatelet therapy using the intraoral bleeding time after dental extractions.~   "
49574|NCT02918032|"~     This study aims to understand the state of onset of NLSD(neutral lipid storage disease) /~     TGCV(triglyceride deposit cardiovasculopathy) worldwide, background information of affected~     patients, and natural history of the disease, as well as exploring the prognostic factors and~     assessing the efficacy of disease-specific treatment.~   "
49575|NCT02918019|"~     This is a Phase IIb, randomized, placebo-controlled, double-blind, multicenter, multi-arm~     study will evaluate efficacy, safety, and pharmacokinetic of MSTT1041A compared with placebo~     as add-on therapy in participants with severe, uncontrolled asthma who are receiving medium-~     or high-dose inhaled corticosteroid (ICS) therapy and at least one of the following~     additional controller medications: long-acting beta-agonists (LABA), leukotriene modifier~     (LTM), long-acting muscarinic antagonist (LAMA), or long-acting theophylline preparation. The~     total duration of this study for each participant is approximately 70 weeks including~     screening, run-in, treatment, and follow-up.~   "
49576|NCT02918006|"~     A Phase 2 Randomized, Placebo- and Active-Controlled, Human Influenza A/California/04/2009~     (H1N1) Challenge Study Following Administration of an Oral H1N1 HA Adenoviral-Vector Based~     Seasonal Influenza Vaccine and dsRNA Adjuvant (VXA-A1.1) to Healthy Adult Volunteers.~   "
49577|NCT02917993|"~     The purpose of this study is to evaluate the safety and tolerability of INCB039110 in~     combination with osimertinib in subjects with locally advanced or metastatic non-small cell~     lung cancer (NSCLC).~   "
49578|NCT02917980|"~     This project aimed to optimize the therapeutic strategy for structural heart disease by~     choosing optimal treatment, such as,surgical treatment,interventional and surgery combined~     with interventional hybrid treatment. Thereby improve successful rate of clinical treatment,~     and establish the guideline for treatment of structural heart disease.At the same time,online~     registration database for structural heart disease will be established to further data~     analysis and objective assessment of clinical curative effect for structural heart disease in~     China.~   "
49579|NCT02917967|"~     This is a longitudinal, prospective, and open-label interventional study in a single center.~     We will investigate the effect of single injection in each patient. This study was designed~     to establish the clinical evidence for effect of botulinum toxin type a (Dysport,~     abobotulinum toxin A) injection on changes in musculotendinous length and dynamics of~     hamstring muscles during gait in children with spastic cerebral palsy walking with excessive~     knee flexion.~      Baseline data such as Modified Ashworth scale (MAS), Modified Tardieu scale (MTS), Gross~     Motor Function Measures (GMFM), and Gross Motor Function Classification System (GMFCS) level~     will be assessed. Gait analysis will be performed using a computerized gait analysis system~     (VICON MX-T10 System with 6 infrared cameras, Oxford Metrics Inc., Oxford, UK) to measure the~     kinematic data (angle of each joint) during the gait cycle. A trained investigator will place~     14 reflective markers on the anterior and posterior superior iliac spine, the mid points of~     the lateral femur, the lateral knee joint axis, the midpoints of the lateral tibia, the~     lateral malleolus, and the dorsal foot between metatarsal heads 2 and 3. All subjects should~     walk barefoot at a self-selected speed along an 8-meter path with the markers in place and~     the motion will be captured with a 100-Hz sampling frequency. Force-plates (AMTI OR 6-5,~     Advanced Mechanical Technology, Newton, MA, USA) under the path will record ground reaction~     forces during the walking trials with a 1000-Hz sampling frequency, and joint moments will be~     expressed as internal moments to counter the ground reaction forces. Data collection will~     continue until the subject achieved at least 3 'clean' force-plate strikes. Kinematic and~     kinetic data from successful trials will be used for statistical analysis. Video recording~     will be done simultaneously from the front, rear, and side, with the 3D gait analysis.~   "
49580|NCT02917954|"~     Canadian and international health care systems require solutions on how to address the needs~     of a relatively small population that take up a large portion of health care resources. In~     Ontario, 10% of the population accounts for 79% of total system costs, with similar trends~     found in other parts of Canada and internationally. Most high-cost users are seniors, older~     adults, with multiple chronic conditions and complex care needs who are living in the~     community. Beyond the cost issues, older adults experiencing multi-morbidity are at~     higher-risk of poor health outcomes and experience lower quality of life as compared to~     individuals experiencing single illness only.~      Since April 2013 the electronic Patient Reported Outcomes (ePRO) mobile application and~     portal, has undergone a multi-phased, user-centred design evaluation approach to develop a~     tool designed to meet the needs of older adults with complex care needs and their primary~     care providers. The ePRO tool is designed to collect person-centred, person-reported~     indicators to improve care by supporting primary care delivery and enhancing patient~     self-management.~      The ePRO tool includes two features: 1) My Goal Tracker and 2) Health Journal. My Goal~     Tracker allows patients and providers to collaboratively create goal-oriented patient~     care-plans, and helps patients to track outcomes related to their goals using a mobile~     device. The Health Journal allows patients, their caregivers and primary care providers to~     monitor patients' symptoms and outcomes. The ePRO tool was re-evaluated and modified~     following each previous study phase (I-IV). This project marks the final phase of the study~     in which the investigators will conduct a pragmatic trial of the ePRO tool in 8-16 Family~     Health Teams in Ontario through a stepped-wedge randomized trial with an embedded case study.~     In this evaluation of the tool the investigators will assess outcome, process and context~     measures to identify how the tool affects patients, providers and the system at~     point-of-care.~   "
49581|NCT02917941|"~     The purpose of this study is to evaluate the efficacy and safety of ixazomib plus~     lenalidomide and dexamethasone in Japanese patients with relapsed and/or refractory multiple~     myeloma.~   "
49594|NCT02917772|"~     TITAN RCC (0216-ASG) is a Phase 2, open-label study of nivolumab monotherapy with additional~     nivolumab/ipilimumab boost cycles in previously untreated and pretreated (2nd line),~     advanced or metastatic renal cell carcinoma (mRCC) subjects with intermediate and high risk~     disease according to IMDC.~   "
49582|NCT02917928|"~     The investigators hypothesise that carnosine supplementation will improve:~        1. glycaemic control~        2. cardiovascular risk factors~        3. cognitive outcomes~      in patients with prediabetes and type 2 diabetes, and this will be modulated by reduction in~     chronic low grade inflammation, oxidative stress and circulating advanced glycation end~     products levels.~      3. Aims~      To determine the potential of carnosine supplementation for 14 weeks to improve glycaemic~     control in type 2 diabetes, reduce risk factors for cardiovascular disease and improve~     cognitive function as well as identify metabolic pathways involved, specifically by:~        1. Improving glycaemic control (HBA1c, fasting and 2 hour glucose and glucose area under~          the curve after oral glucose tolerance test)~        2. Reducing cardiovascular risk factors (lipids; arterial (aortic) stiffness; central blood~          pressure (cBP); endothelial function).~        3. Improve cognitive function (global cognitive score formed by a composite of 4 cognitive~          tests)~        4. Decrease the chronic low grade inflammation, oxidative stress, advanced glycation end~          products, and advanced lipoxidation end products, and increase detoxification of~          reactive carbonyl species (RCSs).~   "
49583|NCT02917915|"~     Chronic obstructive pulmonary disease (COPD) is a chronic lung disease primarily caused by~     smoking. Pulmonary rehabilitation (PR) is an evidence-based, interdisciplinary, and~     comprehensive intervention for COPD patients that includes patient assessment, exercise~     training, and self-management education to promote behavior changes. PR has been shown to be~     the most effective strategy to improve clinical health outcomes, and is now considered to be~     a standard of care intervention for individuals with COPD who remain symptomatic despite~     optimal drug therapies. Despite considerable evidence supporting the effectiveness of PR at~     enhancing clinical outcomes, it is unclear if PR influences the behaviors that promote COPD~     management (i.e., physical activity, medication adherence, self-managing exacerbations).~      In collaboration with the local clinical staff as well as national colleagues and the~     Canadian Thoracic Society, a new national pulmonary rehabilitation program has been~     co-developed that is designed to increase physical activity, medication adherence, and skills~     to help manage chronic lung diseases. The new program aims to increase people's confidence~     and autonomy for performing disease-management behaviors, and has been designed to be more~     effective at increasing physical activity, medication adherence, and disease management~     skills than previous pulmonary rehabilitation programs. The program is designed to be~     delivered within different settings of practice, including traditional PR centers, satellite~     sites (i.e., sites that are remote from the major institutions),with the use of Tele-health~     and web-based resources, and primary care medical centers. The effectiveness of the new~     Standardized Canadian PR program will be assessed relative to the traditional PR program.~     This trial is an important step towards establishing the necessary evidence that will then~     enable us to work on dissemination and implementation of this new standardized PR program~     across the country.~   "
49584|NCT02917902|"~     To compare the effectiveness of providing monthly boxes of nutritious foods to low-income~     patients with diabetes on site at Free Clinics with referrals to off-site food pantries on~     diabetes related health outcomes~   "
49585|NCT02917889|"~     Check the acute influence of caffeine on the autonomic modulation and cardiorespiratory~     parameters after aerobic exercise. Hypothesized that caffeine can promote a slower recovery~     of the cardiorespiratory parameters and the SNA recovery after aerobic exercise.~   "
49586|NCT02917876|"~     This study seeks to understand the physical, physiologic and biologic features that~     predispose a woman to the development of obstructive sleep apnea once they are exposed to the~     cardiopulmonary and metabolic physiological changes of pregnancy. Knowing these specific~     predictive factors can help identify a population at risk and guide clinicians to develop~     suitable targeting screening strategies.~   "
49587|NCT02917863|"~     Thyroid disorders, in particular hypothyroidism, are associated with gastrointestinal~     impairment, such as celiac disease. A study reported an increased prevalence of celiac~     disease in a large cohort of children affected by congenital hypothyroidism, underlying the~     relationship between these two conditions. The hypothesis of our study is that the onset of~     celiac disorder may be related to the gut concentration of thyroid hormone (TH) in~     hypothyroidism patients treated with replacement therapy. In fact, TH replacement therapy~     showed a low bioavailability with a consequent high gut concentration. Two different~     pharmaceutical formulations (liquid and solid, per os) are available. The liquid one has a~     better absorption profile and bioavailability than the solid; therefore, it is associated~     with a low TH intestinal concentration. According to our hypothesis, the solid TH formulation~     could increase the microbial diversity in the gut instead of the liquid form, due to the high~     local TH concentration. Based on these findings, the purpose of this study is to evaluate the~     effect of two different pharmaceutical formulations of TH on the gut in terms of modification~     of gut microbiota, inflammatory parameters and gut absorption.~   "
49588|NCT02917850|"~     Post-stroke patients often present with gait disorders due to several physical impairments.~     Hip flexor deficit is one of the more prevalent trouble and is associated with gait~     capacities. This study aims at evaluating the impact of an isokinetic hip flexors~     strengthening rehabilitation program in the subacute phase after stroke. Patients will be~     randomized to an intervention group (isokinetic rehabilitation) or a control group~     (conventional rehabilitation) and assessed at the end of the rehabilitation program, at 3 and~     at 6 months.~   "
49589|NCT02917837|"~     Diagnostic imaging (DI) tests (for example, x-ray tests, ultrasounds, CT scans, or MRIs) are~     used by health care providers to help diagnose patient illness, but decisions regarding when~     these tests should be ordered are subjective. As a result, some physicians order these tests~     more than others. Ordering rates between clinicians seeing similar kinds of patients have~     been shown to be considerably different, suggesting that many of the tests are unnecessary.~     DI currently accounts for about 6.6% of Canadian hospital budgets, but this percentage may be~     much higher in Newfoundland where test ordering rates are almost twice the national average.~     However, cost is not the only concern. Over-testing can lead to further unnecessary testing~     to follow-up on harmless findings, and in the case of CT, large doses of potentially harmful~     radiation. The purpose of this study is to assess DI test-ordering by family physicians~     across the Eastern Health region, and compare these test ordering rates with those from other~     jurisdictions. We suspect that many clinicians are not aware that they order more DI tests~     than their peers. We will therefore develop a report card for family physicians in the~     province that shows them how many tests they are ordering compared to other physicians in the~     region. We expect that physicians who are over-ordering DI tests will reduce the number of~     tests they order after receiving their report cards. This is a low-cost way to potentially~     prevent expensive over-ordering of DI tests that can easily be implemented in the province's~     other health regions and elsewhere.~   "
49590|NCT02917824|"~     Inspiratory muscle training (IMT) can reverse or delay the complications from the~     deterioration of inspiratory muscle function in asthma. Thus, the IMT has been considered a~     treatment option for people with asthma. The aim of this study is to investigate the training~     principles of intensity, specificity and reversibility of IMT in asthmatics.~   "
49596|NCT02917746|"~     This multi-center, open-label, non-randomized controlled intervention study aims to~     investigate the treatment efficacy, side-effects and quality of life associated with~     imiquimod treatment of high-grade CIN lesions, as an alternative to surgical treatment by~     Large Loop Excision of the Transformation Zone (LLETZ). Non-surgical treatment may prevent~     side-effects associated with surgical treatment, such as premature birth in subsequent~     pregnancies. The study hypothesis is that approximately 75% of patients with high-grade CIN~     will be adequately treated with imiquimod.~      120 women with a histological diagnosis of CIN2 or CIN3 will be included and allocated to one~     of two treatment arms according to their preference:~        1. Imiquimod treatment arm(60 patients). Patients in this group are treated with vaginal~          imiquimod 5% cream during 16 weeks.~        2. Standard treatment arm (60 patients). Patients in this group will undergo LLETZ~          treatment.~   "
49597|NCT02917733|"~     This type of study is called a radiolabeled study. For this study, LY3039478 (study drug) has~     been specially prepared to contain radiolabeled carbon [¹⁴C]. [¹⁴C] is a naturally occurring~     radioactive form of the element carbon. This study will help determine how the drug appears~     in the blood, urine, and stool after it is administered by mouth to healthy people.~     Information about any side effects that may occur will also be collected. This study will~     last about 10 weeks for each participant.~   "
49598|NCT02917720|"~     The main goal of the study is the assessment of duration of major molecular response (MMR) or~     better at 12 and 36 months after stopping tyrosine kinase inhibitors (TKI) therapy a second~     time in patients with at least three years prior TKI treatment comprising at least two years~     of nilotinib treatment within this trial and maintained stable MR4 (BCR-ABL ratio <0,01% on~     international Scale (IS) for at least one year and MR4.5 (BCR-ABL ratio <0,0032% on IS) for~     at least 6 months:~        -  who failed a first stop in the EURO-SKI study (standardized criteria)~        -  who failed a first stop outside the EURO-SKI study but would have had fulfilled same~          eligible criteria and were stopped according to EURO-SKI rules~        -  who failed a first stop outside the EURO-SKI study without fulfilling EURO-SKI rules~   "
49599|NCT02917707|"~     The investigators will perform integrative analysis of CRC liver metastasis~   "
49600|NCT02917694|"~     This study aims to assess the feasibility of obtaining details about a patients previous~     level of function from the patient of friend/relative, after they have been admitted an~     intensive care unit (ICU). It will also assess the feasibility of re-assessing level of~     function at 6 months after the patient has been discharged from ICU.~   "
49601|NCT02917681|"~     The study aims to evaluate primarily safety of two injections of autologous mesenchymal stem~     cells in Amyotrophic Lateral Sclerosis patients. Secondary outcomes of efficacy will also be~     evaluated~   "
49602|NCT02917668|"~     This study aims to evaluate the risk of hyperoxia-induced hypercapnia in post-op obese~     cardiac surgery patients. It will compare two oxygenation modes in terms of their effect on~     the arterial partial pressure of carbon dioxide (PaCO2) : manual titration of oxygen delivery~     for a peripheral oxygen saturation (SpO2) target of > or = 95 % versus automatic titration by~     a closed-loop system for a SpO2 target of 90%. 15 post-op obese cardiac surgery patients will~     be recruited and each will receive both interventions (cross-over design). The main outcome~     will be the PaCO2, which will be compared after each study period. The research hypothesis is~     that the usual SpO2 target of > or = 95 % is associated with a greater PaCO2 compared with a~     lesser SpO2 target of 90%.~   "
49603|NCT02917655|"~     BACKGROUND: Osteoarthritis (OA), and particularly knee osteoarthritis (KOA) is a disorder~     that greatly impairs the quality of life of patients and its incidence increases with~     longevity, obesity and lower socioeconomic and educational level. It is expected that 40% of~     people over 60 have symptomatic OA of the knees and hips. The core treatment of OA is~     education, weight loss and increased physical activity. We create an educational program that~     improved function of the patients given by the five-times-sit-to- stand test (FTSST).~     However, weight loss, an important foundation of clinical treatment, was only effective (more~     than 2 points in BMI) in 10% of the program participants. For greater effectiveness in weight~     loss and adherence to physical activity, we prepared an intensive program with more intensive~     nutritional care, psychological, physical therapy and physical trainers and compare the~     existing program educators. OBJECTIVE: To compare an educational program isolated to an~     educational program associated with nutritional consultations, group therapy sessions and~     progressed physiotherapy sessions to sessions with physical educators in patients with KOA~     and comorbidities (metabolic syndrome).~      METHODS: Ninety patients with OAJ and co-morbidities (Two or more of: overweight or obesity,~     hyperglycemia, dyslipidemia, hyperuricemia, high blood pressure) will be divided into two~     groups: study (S) and control (C). Both groups will attend the two-day multi-professional~     classes on OA with two months interval. But the study group will also make three group~     consultations about nutrition, 1 extra session of group therapy with psychology team and 7~     exercise sessions in groups with physical therapy and subsequently 7 sessions with physical~     educators. The groups will be evaluated for weight, height (to calculate BMI), waist-hip~     ratio, percentage of body fat, consumption of daily medications, WOMAC, Lequesne, IPAQ, Tampa~     Scale for Kinesiophobia (TSK), test sits and rises, timed-up- and-go (TUG) and six minute~     test. At inclusion, six, twelve and 24 months after the classes.~   "
49604|NCT02917642|"~     The purpose of this clinical study was to compare the effectiveness of passive ultrasonic~     irrigation with that of traditional syringe irrigation on the removal of bacteria and~     endotoxin (lipopolysaccharide [LPS]) from root canals.~   "
49605|NCT02917629|"~     This randomized phase IIb trial studies how well ACTOplus met XR works in treating in~     patients with stage I-IV oral cavity or oropharynx cancer that are undergoing definitive~     treatment. Chemoprevention is the use of drugs to keep oral cavity or oropharynx cancer from~     forming or coming back. The use of ACTOplus met XR may slow disease progression in patients~     with oral cavity or oropharynx cancer.~   "
49606|NCT02917616|"~     This study evaluates the effect of alkaline (pH=9) versus neutral (pH=9) drinking-water on~     the gut microbiota of healthy male volunteers.~   "
49615|NCT02917499|"~     The goal of this study is to examine the efficacy and safety of transcranial magnetic~     stimulation (TMS) and deep TMS (dTMS) for treatment of different psychiatric and neurological~     disorders. Subjects will be randomized into two groups: experimental (treated with~     pharmacotherapy and TMS) and control group (treated only with pharmacotherapy). They and~     their clinicians will complete a battery of instruments that measure relevant symptoms,~     global functioning and quality of life. The first measurement will be done after the~     inclusion and before treatment. The second measurement will be made immediately after the end~     of treatment (after 4 weeks). The other measurements (follow-up) will be made after 3 and 6~     months.~   "
49616|NCT02917486|"~     The objective of the study is to investigate the exposure difference between antibiotic~     studied patients in intensive care with Extracorporeal Membrane Oxygenation and patients~     without Extracorporeal Membrane Oxygenation.~      The exhibition is evaluated by population pharmacokinetic modeling.~   "
49607|NCT02917603|"~     Twenty-eight percent of Americans over the age of 65 die in a nursing home. Research has~     found the quality of care of end-of-life care in nursing homes to have many challenges. It~     has also been documented that family members, especially those living at a distance, want to~     be involved in the care of their resident and family support can be beneficial to residents.~     Family members' involvement in decision-making in the nursing home setting improves outcomes~     for residents with life-limiting illnesses. Shared decision-making is a process wherein a~     healthcare choice is jointly made by a healthcare provider and a resident or resident's~     proxy, often a family member. This proposal seeks to facilitate SDM among family members,~     residents with life-limiting illnesses (who are not enrolled in hospice), and the nursing~     home care team. The overall research question (RQ) asks: To what extent are outcomes for~     family member and residents with life limiting illnesses associated with SDM via~     web-conferencing in the nursing home? The overall hypothesis (H) is that SDM among family~     members, residents (when possible), and skilled nursing home staff via web-conferencing will~     improve outcomes for family members and residents with life-limiting illnesses. This is an~     exploratory mixed methods randomized clinical trial pilot to test the effect of shared~     decision making using web-based conferencing on the depression and burden of family members~     and the pain of nursing home residents.~   "
49608|NCT02917590|"~     Is dual-task obstacle crossing training more efficiently than single-task obstacle crossing~     training on the improvement of walking ability, balance ability, and lower extremity muscle~     strength in ambulatory subjects with spinal cord injury~   "
49609|NCT02917577|"~     The study is a prospective, single centre, double-blinded randomized controlled trial whose~     goal is to compare the immune response of a population of immunosuppressed pediatric~     rheumatology patients on immunosuppressive medications to two different doses of Hepatitis A~     vaccine. The objectives are (a) to confirm that adolescents, like their adult counterparts,~     have a reduced immune response to hepatitis A vaccine, and (b) to compare the immunogenicity~     of two different dosing options of vaccine for this age group after one and two doses. A~     total of 60 adolescents aged 12 - 15 years with confirmed chronic rheumatologic conditions~     for which they are being treated with an immunosuppressive therapy will be recruited from the~     Rheumatology Clinic at Alberta Children's Hospital (ACH). Those found to have no immunity to~     hepatitis A will be enrolled. Informed, written consent will be obtained from the parent or~     guardian of subject, with assent obtained from the study subjects. Subjects will be randomly~     assigned to two doses of either Avaxim Pediatric® or Avaxim ® (adult) vaccine (Sanofi Pasteur~     Canada), six months apart, with hepatitis A titres done at baseline and one month after each~     dose. Both formulations are licensed for this age group.~   "
49610|NCT02917564|"~     During glaucoma surgery, a new opening is created that allows fluid to drain out of the eye,~     bypassing the clogged drainage channels that are malfunctioning in patients with glaucoma. In~     some patients who have had glaucoma surgery too much fluid flows out and this results in a~     pressure that is too low. This may cause swelling of one layer at the back of the eye called~     the choroid. The formation of this swelling, called a choroidal effusion or choroidal,~     often makes the eye pressure stay too low, and one of the results is a decrease in vision.~     The treatment for a choroidal effusion is to try to raise the eye pressure somewhat to allow~     the swelling to subside. In our clinical work, we have found that an injection with an~     anti-inflammatory drug called triamcinolone appears to be helpful in speeding up healing. We~     plan to compare two groups of patients with choroidal effusions, one group that gets an~     injection of triamcinolone and one that gets a sham treatment with nothing injected and~     compare the length of time it takes the choroidal effusions to disappear. Both groups receive~     the standard treatment with eye drops. We will also assess the outcome of the glaucoma~     surgery and any other complications that may occur. This research is aimed at studying a new~     method of improving the outcomes of surgery for glaucoma patients, and further the treatment~     of glaucoma.~   "
49611|NCT02917551|"~     The burden of bloodstream infections is large and increasing over time. Antibiotic overuse~     continues to drive increased rates of antimicrobial-resistant pathogens across Canada.~     However, prospective audits have revealed that 30-50% of antibiotic utilization is~     unnecessary or inappropriate. If shorter duration therapy is as effective as longer duration~     therapy for these infections, antimicrobial consumption would be decreased. A pilot trial~     (approved by the Sunnybrook Research Ethics Board), is underway in critically ill patients at~     17 Canadian ICUs. Investigators have successfully demonstrated feasibility with respect to~     protocol adherence and recruitment rates in the ICU. Investigators now aim to conduct a~     similar pilot RCT among non-ICU patients admitted to hospital wards with bloodstream~     infections to determine feasibility and protocol adherence of the same trial protocol.~   "
49612|NCT02917538|"~     A clinical randomized trial to evaluate if CF guided Radio Frequency Ablation (RFA) to a~     specific of LSI in atrial flutter i superior to standard RFA.~   "
49613|NCT02917525|"~     Early development of calcified aortic valve disease (CAVD) is a commonly occurring~     complication in patients with a bicuspid aortic valve (BAV, an aortic valve consisting of two~     leaflets instead of three). In general, CAVD is characterized by progressive narrowing of the~     aortic valve, with involvement of altered calcium metabolism. CAVD progression in fact may~     lead to necessity of valve replacement, since to date, no other therapies have been shown~     effective in the treatment of CAVD.~      The primary objective of our study is to test the hypothesis that supplementation of vitamin~     K2 will slow down the calcium metabolism in CAVD. Vitamin K2 is essential in the activation~     of matrix Gla Protein (MGP), an important inhibitory factor in the regulation of~     calcification.~      In this randomized controlled trial, 44 patients will be allocated to either the vitamin K2~     or placebo group. To assess the calcification process in a detailed manner in these patients,~     a Positron Emission Tomography (PET) scanner using a tracer (18F-fluoride [NaF]) that has~     been shown to bind to regions of newly developing microcalcification in aortic valve tissue~     is used.~      We expect that vitamin K2 supplementation will reduce the calcium metabolism in the aortic~     valve on 18NaF-PET (primary endpoint) and slow progression of CAVD as measured by the calcium~     score on CT and echocardiography after 18 months (secondary endpoints), when compared to~     placebo.~   "
49614|NCT02917512|"~     A multicenter, Placebo controlled, Restasis® referenced, Randomized, Double blind, Phase II~     Study to Evaluate the Efficacy and Safety of HU00701/HU007 Eye Drops in Adult Patients with~     Dry Eye Syndrome~   "
49617|NCT02917473|"~     First-degree relatives of patients with melanoma have a greater risk of developing melanoma.~     Patients are advised orally to inform their first-degree relatives that they should protect~     their skin from UV radiation and ask for a skin examination from a general practitioner or~     dermatologist. The study will evaluate the effectiveness of a written sheet in addition to~     the usual oral counselling to increase acceptance of skin examination by the first-degree~     relatives. If effective, written counselling provided to the patient for relatives should be~     recommended and generalized.~   "
49618|NCT02917460|"~     Rady Children's Institute for Genomic Medicine (RCI) will collect biological samples (such as~     blood), derived genomic sequences (from DNA and RNA), and clinical features in a~     Biorepository as a standardized resource for future research studies. The purpose of the~     Genomic Institute Biorepository is to provide consented samples and data for basic and~     clinical research related to the genomic cause and treatment of childhood disease, and, in~     the future, as reference (Quality Control) data to improve the ability to make clinical~     diagnoses or clinical decisions.~      In addition, the Biorepository will provide a mechanism for making a diagnosis of a genetic~     disease. That is, once genomic sequences have been derived from biological samples, they will~     be immediately analyzed. If a genetic disease is identified that appears to explain an~     affected child's clinical features, then those results will be confirmed by the medically~     accepted standard, and placed in the electronic health record.~   "
49619|NCT02917447|"~     The purpose of this study is to evaluate an online PTSD intervention that was adapted for~     women Veterans, called DElivery of Self TRaining and Education for Stressful Situations-Women~     Veterans version (DESTRESS-WV). The intervention consists of structured online sessions as~     well as weekly brief phone calls for additional support with a study coach. Women Veterans~     with PTSD who are eligible will be randomized to receive either DESTRESS-WV or phone~     monitoring only for 8 weeks. Participants will be assessed immediately post-treatment as well~     as at 12 and 24 weeks post-treatment. Investigators hypothesize that participants randomly~     assigned to DESTRESS-WV will have a greater decrease in severity of PTSD symptoms compared to~     those randomly assigned to phone monitoring only.~   "
49620|NCT02917434|"~     The study is an open intervention study with the aim to determine the effects of weight-loss~     treatment with Low-Energy liquid Diet (LED) on disease activity, quality of life and markers~     of the metabolic syndrome in patients with psoriatic arthritis and obesity.~   "
49621|NCT02917421|"~     This protocol is for patients with newly diagnosed breast cancer with an indication for~     post-operative radiotherapy after neo-adjuvant chemotherapy and surgery.~   "
49622|NCT02917408|"~     Retrospective study of all patients diagnosed with primary biliary cholangitis during January~     2001 to July 2016 at West China Hospital by review of medical records. The following~     variables will be retrospectively studied: age, sex, first symptoms, clinical~     characteristics, pathology, treatment, stage, complications of cirrhosis, other autoimmune~     diseases and long-term outcome.~   "
49623|NCT02917395|"~     Population study- patients with obstructive hypertrophic cardiomyopathy that are treated with~     disopyramide.~      Tow echo examination, few hours apart, that includes strain rate will be done to each~     patient. The first, after taking the regular medical treatment excluding disopyramide and the~     last one after taking the disopyramide.~   "
49624|NCT02917382|"~     Liver transplantation (LTx) is the standard treatment used in the final stage of chronic or~     acute liver failure. The success for the LT depends on many factors. One of the factors~     related to morbidity and mortality of these patients is malnutrition. Patients on the waiting~     list for LTx are increased risk of malnutrition and metabolic disorders that may be~     associated with decreased functional capacity, change in resting energy expenditure cardiac~     autonomic dysfunction. These conditions may influence the results both before and after~     transplantation, as the clinical outcome and complications present in the postoperative~     period. Therefore, this study aims to characterize and relate nutritional status, metabolic,~     functional and clinical outcomes in the recent postoperative patients undergoing liver~     transplantation. It is an observational, prospective study based on four evaluations: the~     first will be conducted while the patient is awaiting transplantation; and after insertion of~     the graft, patients will be evaluated between the 1nd and 3th postoperative day, between 5~     and 7 days and at discharge from hospital.~      In the late post-transplant, there is the action of immunosuppressive drugs, largely~     responsible for increased survival, but also on the other hand, are responsible for important~     nutritional and metabolic disorders. Metabolic complications such as hyperkalemia,~     hypertension, diabetes mellitus and overweight have been described. Thus, due to the high~     incidence of these complications, alternative options, such as lowering the dose of~     immunosuppressive drugs, have been fully explored, particularly as regards association with~     the viability of the graft. However, few studies have evaluated whether there is change in~     the incidence of metabolic disorders, cited above, in relation to the different doses of~     immunosuppressive drugs. Furthermore these metabolic complications will be evaluated in the~     late post-transplant period.~   "
49625|NCT02917369|"~     Integrative analysis of LCLC~   "
49626|NCT02917356|"~     Osteoarthritis (OA) is the most common form of chronic degenerative joint disease, as well as~     the main cause of pain and disability in older persons worldwide. The limited results of~     physical therapy in OA makes OA patients potential candidates for complementary therapies,~     such as laying on of hands. The present study aims to investigate the effect of Laying on of~     Hands on the Pain, Joint Stiffness and Functional Capacity of Elderly Women With Knee~     Osteoarthritis. This is a randomized controlled trial with three allocation groups: spiritual~     laying on of hands (passe espiríta - Spiritist passe/spiritual healing) (SP), non-spiritual~     laying on of hands (LH) and Control Group without laying on of hands (CG). All subjects will~     participate in a 45-minute kinesiotherapy program. After that, groups will be directed to the~     5-minute session of laying on of hands according to their groups. During the application of~     SP, LH and CG, the subjects will remain in a sitting position, blindfolded with dark goggles,~     and receive the following verbal command: Relax and calm your mind. The intervention will~     happen twice a week for eight weeks and a blinded physical therapist will assess the pre and~     post scores of pain, functionality, joint stiffness (through WOMAC and visual analogic~     scale), anxiety and depression (HADS), religiosity (DUREL) and spirituality (FACIT Sp12) and~     quality of life (WHOQOL-Bref), among other secondary outcomes.~   "
49627|NCT02917343|"~     The purpose of the study is to determine the effect of a combined mirror therapy and task~     oriented/repetitive task training on upper extremity function of persons with hemiplegia due~     to cerebrovascular accident or stroke.~   "
49641|NCT02917148|"~     The goal of this research proposal is to identify a miRNA expression profile as a biomarker~     to diagnose and predict acute graft versus host disease (aGVHD) in patients who undergo~     allogeneic transplantation. This biomarker, once identified, will need validation in larger~     cohorts.~   "
49642|NCT02917135|"~     This is a post-market, observational, retrospective multi-center Registry designed to gather~     information on the performance of the Angel® Catheter in general clinical practice.~   "
49628|NCT02917330|"~     The purpose of this randomized and controlled intervention study is to explore the effect of~     a physiotherapy intervention targeting contract and spastic hamstring muscles in children~     having bilateral spastic cerebral palsy (CP), GMFCS I-III: A stretching routine targeting~     hamstrings (and psoas if short), and a progressive strengthening program on the muscles~     extending then lower extremities (quadriceps, gluteus maximus and triceps surae)~      Study hypothesis: Stretching of hamstrings and strength training of the extending muscles in~     the lower extremities in children with bilateral spastic cerebral palsy will increase~     popliteal angle, active knee extension, and gait function.~   "
49629|NCT02917317|"~     To investigate the risk factors and prediction biomarkers of chronic disease in adults aged~     35-74 years.~   "
49630|NCT02917304|"~     The purpose of this study is to evaluate immunological efficacy and safety of GC3110A among~     healthy adults over 65 years of age.~   "
49631|NCT02917291|"~     The main objective of the study is the evaluation of the safety and tolerability of FAB117-HC~     (a medicinal product containing human allogeneic adipose derived adult mesenchymal stem cells~     expanded and pulsed with H2O2, HC016 cells) administered at a single-time point to patients~     with acute thoracic traumatic spinal cord injury (SCI). The study will also include initial~     exploration of potential clinical efficacy. Dose levels of 20 million and 40 million cells~     will be administered.~   "
49632|NCT02917278|"~     This pilot study aims to produce preliminary data on the safety of providing high-protein~     meals to patients during dialysis, and effects of this intervention on nutritional status and~     quality of life outcomes. This is a non-randomized, parallel arm study. Meals provided will~     follow recommended dietary guidelines for HD patients and will provide approximately 1/3 of~     daily recommended protein intake. Patients will be allocated to either the treatment or~     control group by HD shift schedule. 2 months of baseline data will be collected, followed by~     9 weeks of meal intervention/control and data collection. The primary outcome will be~     frequency of hypotensive events during dialysis requiring intervention. Secondary outcomes~     will include highest and lowest systolic blood pressure during dialysis, blood biochemistries~     including measures of renal function, nutritional status, and electrolyte balance; dialysis~     compliance; fluid retention; sleep and other quality of life measures; and dietary intake~     data.~   "
49633|NCT02917252|"~     This study evaluate the metabolic effects of orally ingested ketone bodies. The study is~     conducted as a randomized, cross over study.~   "
49634|NCT02917239|"~     Overall survival of multiple myeloma (MM) patients has increased significantly due to the~     availability of the new drugs. Moreover, since MM is an incurable disease, patients are~     exposed to repeated lines of therapy with different agents. It is therefore increasingly~     important to monitor the long-term side-effects of treatments. In the present study we~     focused on ocular disorders. This is an observational study aiming to assess the prevalence~     of ocular disorders in 100 patients on treatment or follow-up for MM.~   "
49635|NCT02917226|"~     The purpose of the study is to develop a user-friendly, comprehensive, fully integrated web~     and mobile-based Clinical Decision Support and Monitoring System (CDSMS) for DM diseases~     screening, diagnosis, treatment and monitoring for the use of physicians and patients in~     primary care and to determine the effectiveness of the system. For validating the CDSMS for~     diabetes patients, randomized controlled trial will be conducted.A parallel single blind~     randomized controlled trial will be implemented. 10 physicians and their 439 patients are~     involved in the study. According to the results of screening which is done using developed~     CDSMS, DM diagnosed patients will be recruited for trial from the primary care centers by the~     physicians. The recruited patients will register to the CDSMS with their accounts given by~     their physicians. Eligible participants will be assigned to intervention and control groups~     with simple randomization. The significance level will be accepted as p<0,05. In the~     intervention group, the system recommendations on diagnosis, treatment and monitoring will be~     carried out as the final decision given by the physician. In the control group, physicians~     will treat DM patients as the general routine. Patients in both groups will be monitored for~     6 months. Patient data on 0th and 6th month will be compared. Clinical and laboratory~     outcomes will be face-to-face assessed, others will be online self-assessed.~   "
49636|NCT02917213|"~     This project aims to assess the ability of cardiac imaging (cardiac MRI and~     Doppler-echocardiography) post-processing tools to predict a combined end-point of~     intraventricular thrombosis, silent brain infarcts, clinical stroke and peripheral arterial~     embolism in patients with first acute myocardial infarction and ventricular dysfunction.~   "
49637|NCT02917200|"~     The purpose of this study is to evaluate whether different DAV132 dose regimens are safe and~     effective for capturing fecal residues of moxifloxacin in healthy volunteers.~   "
49638|NCT02917187|"~     The primary objective of the study is to investigate the efficacy of repeat oral dosing of~     BIIB074 on paroxysmal pain in participants with Primary Inherited Erythromelalgia (EM). The~     secondary objective of the study is to investigate the efficacy of repeat oral dosing of~     BIIB074 on varying additional aspects of pain in participants with EM; and to investigate the~     safety and tolerability of repeat oral dosing of BIIB074 in participants with EM.~   "
49639|NCT02917174|"~     Bronchial asthma is a heterogeneous disease characterized by chronic airway inflammation,~     which is a common and frequently occurring disease in the world, and has resulted in a~     sustained increase of social and economic burden. However, several studies suggest, lots of~     asthma patients did not get their asthma controlled. The investigators study showed that in~     China only 28.7% of asthma patients achieve asthma controlled during 2007-2008. In recent~     years, application softwares of mobile-phones for asthma have gradually increased, studies~     suggested that application of these application softwares can make treatment more standard,~     reduce asthma attacks, help patients to control their asthma, improve adherence and these~     application softwares also show many other advantages. This study is a prospective, multi~     center, randomized, controlled study, aims to evaluate the efficacy of application softwares~     in asthma patients, provide a new tool to asthma management.~   "
49640|NCT02917161|"~     MRI findings after successful PAE in patients suffering from BPH suggest a complete necrosis~     of the prostate after this intervention. Thus, PAE might also play a role in the treatment of~     prostate cancer.~      This proof of concept study assess the impact of PAE in patients with proven prostate cancer.~   "
49643|NCT02917122|"~     Parkinson's disease (PD) is one of the most common neurological diseases manifested by~     movement disturbance. The concomitant psychiatric symptoms, especially depression, are often~     observed and have also great impact on patients' quality of life. The treatment of depressive~     symptoms in PD with antidepressants as the majority remains variable and inefficient, which~     complicates the disease prognosis. Transcranial direct current stimulation (tDCS) is a~     non-invasive brain modulation technique and has been demonstrated to improve psychiatric~     diseases such as major depression. In this study the investigators will assess the combined~     effects of tDCS on sertraline for the treatment of depression in PD. Ten sessions of tDCS in~     two weeks will be applied and the follow-up evaluation will continue bi-weekly for one month~     after completing all sessions. The efficacy of tDCS vs sertraline will be compared and~     evaluated with behavioral and cognitive outcome. In addition, the investigators will evaluate~     if the baseline dopaminergic activity in brain could predict the treatment outcome by using~     SPECT imaging. The investigators aim to establish the therapeutic parameters and safety~     criteria of tDCS as an add-on or alternative therapy, and further enhance the overall~     clinical efficacy in the treatment of depression in PD.~   "
49644|NCT02917109|"~     The purpose of this investigation is to conduct a series of case studies on the impact of~     LearningRx cognitive training on cognitive skills, brain structure, and daily functioning for~     participants with ADHD.~   "
49645|NCT02917096|"~     This pilot clinical trial studies the side effects and best dose of ruxolitinib phosphate~     when given together with chemotherapy before and after a donor stem cell transplant in~     treating patients with myelofibrosis. Ruxolitinib phosphate may stop the growth of cancer~     cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy,~     such as fludarabine phosphate and melphalan, work in different ways to stop the growth of~     cancer cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Giving ruxolitinib phosphate together with chemotherapy before and after~     a donor stem cell transplant may help stop the growth of cells in the bone marrow, including~     normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's~     immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor~     are infused into the patient they may help the patient's bone marrow make stem cells, red~     blood cells, white blood cells, and platelets. The donated stem cells may also replace the~     patient's immune cells and help destroy any remaining cancer cells.~   "
49646|NCT02917083|"~     The subject has a type of lymph gland cancer called Lymphoma.~      The body has different ways of fighting infection and disease. No single way seems perfect~     for fighting cancer. This research study combines two different ways of fighting disease:~     antibodies and T cells. T cells, also called T lymphocytes, are special infection-fighting~     blood cells that can kill other cells, including tumor cells or cells that are infected with~     germs. Both antibodies and T cells have been used to treat patients with cancers; they both~     have shown promise, but have not been strong enough to cure most patients. Investigators hope~     that both will work better together.~      Investigators have found from previous research that they can put a new gene into T cells~     that will make them recognize cancer cells and kill them. They now want to test whether these~     genetically modified T cells given after chemotherapy will be more effective at killing~     cancer cells.~      The gene that will be put into the T cells makes an antibody called anti-CD30. This antibody~     sticks to lymphoma cells because of a substance on the outside of the cells called CD30.~     Anti-CD30 antibodies have been used to treat people with lymphoma, but have not been strong~     enough to cure most patients.~      For this study, the anti-CD30 antibody has been changed so that instead of floating free in~     the blood it is now joined to the T cells. When an antibody is joined to a T cell in this way~     it is called a chimeric receptor. These CD30 chimeric receptor-activated T cells (CD30.CAR T~     cells) seem to kill some of the tumor, but they don't last very long and so their chances of~     fighting the cancer are unknown.~      Several studies suggest that the infused T cells need room to be able to multiply and grow to~     accomplish their functions, and that this may not happen if there are too many other T cells~     in circulation. Because of that, doctors may use chemotherapy drugs to decrease the level of~     circulating T cells prior to the CD30.CAR T cells infusion. This is called lymphodepletion.~      CD30.CAR T cells have previously been studied in lymphoma patients. What is new for this~     study is that lymphodepletion chemotherapy will be administered in patients who are not post~     autologous transplant in the hope that it will result in more durable anti-tumor effects.~   "
49647|NCT02917070|"~     Inbreeding and consanguineous marriages are known to increase the risk of autosomal recessive~     disorders. The aim of this study was to examine the association between consanguinity and~     kidney diseases in the adult Turkish population.~   "
49648|NCT02917057|"~     Exenatide once weekly (Bydureon) was approved in January 2012 by FDA in USA for the treatment~     of type 2 diabetes mellitus. Evidence from clinical trials suggested that Bydureon improves~     glucose control with low risk of hypoglycemia. Bydureon does not require a dose titration as~     necessary for other glucagon-like peptide-1 agonists, and appears to have other advantages,~     such as reducing insulin resistance, reducing weight, and improving blood pressure and lipid~     profiles. However, the degree to which these advantages of Bydureon lead to improve outcomes~     in customary clinical care in patients with mild and moderate renal impairment and in elderly~     patients are unknown.~      The aim of this study is to evaluate the effectiveness and tolerability of Bydureon relative~     to basal insulin initiated as first-ever injectable therapeutic regimens among elderly~     patients and patients with renal impairment. Patients who initiated treatment with Bydureon~     or basal insulin between July 2011 and March 2015 will be recruited into the study cohorts~     from Optum's database of electronic health records. The two treatment cohorts will be matched~     by propensity score method. Changes in HbA1c, weight, markers for renal function (estimated~     glomerular filtration rate (eGFR), serum creatinine, and albumin/creatinine ratio (ACR)), and~     incidences of gastrointestinal symptoms and hypoglycaemia are investigated for patients with~     different eGFR categories and with different ages.~   "
49649|NCT02917044|"~     This is a prospective, multicentre, randomized single blind, parallel group study to be~     conducted in the UK (2 sites).Approximately 48 patients will be recruited aiming for 40~     eligible for randomization. The study is designed to compare the operator's best attempt at~     WACA completion with and without Rhythmia guidance~   "
49650|NCT02917031|"~     This is a 24 week, multicenter, randomized, double-blind, parallel group, placebo-controlled~     study to investigate the effects of saxagliptin and sitagliptin on cardiac dimensions and~     function in patients with type 2 diabetes (T2DM) mellitus and heart failure (HF).~   "
49671|NCT02916732|"~     The Zika (ZIKV) epidemic has spread into the three French Overseas Departments in the~     Caribbean (DFAs). It is therefore urgent to set up tools to collect clinical and paraclinical~     data for the evaluation of potential complications due to having ZIKV infection during~     pregnancy. This study is meant to collect, within usual care practices, clinical and~     paraclinical information which will allow the precise description of the consequences of ZIKV~     infection occurring during pregnancy.~   "
49651|NCT02917018|"~     Emergence agitation is a post-anesthetic phenomenon that develops in the early phase of~     general anesthesia recovery, and is characterized by agitation, confusion, disorientation,~     and possible violent behavior. The incidence of emergence agitation is less common in adults~     as compared to pediatric patients. It may lead to serious consequences for the patient such~     as bleeding, falling, removal of catheters and self extubation, which lead to further~     complications like hypoxia and aspiration.~      Despite its common occurrence, unclear etiology, and serious sequelae, emergence agitation~     has rarely been studied in adults.~      The stress response to surgery is an unconscious response to tissue injury. Activation of the~     sympathetic nervous system, increase of catabolic hormone release and pituitary gland~     suppression are considered a response to surgical stress, in clinical practice these~     activities cause changes in heart rate, blood pressure and biochemical fluctuations of~     noradrenaline, adrenaline, dopamine, and cortisol. Above all, these fluctuations prolong~     hospitalization and delay patients discharge.~      Dexmedetomidine is a highly selective alpha-2 receptor agonist having sedative, analgesic and~     sympatholytic properties. Decreased stress response to surgery ensuring a stable hemodynamic~     state is a beneficial property of the agent. Peri-operative use of dexmedetomidine also~     decreases postoperative opioid consumption, pain intensity, and antiemetic therapy. However,~     the data related to the effects of dexmedetomidine on reducing agitation from general~     anesthesia in adults are limited.~   "
49652|NCT02917005|"~     This is an open label, randomized, multicenter, international phase II study for~     premenopausal patients with hormone receptor positive, HER2 negative metastatic or locally~     advanced breast cancer. Patients will be randomized to receive either palbociclib +~     exemestane + OFS (Arm 1) or exemestane +OFS (Arm 2).~      Treatment will be continued until disease progression, unacceptable toxicities, or withdrawal~     of consent.~   "
49653|NCT02916992|"~     To assess the prevalence of BHD (Birt-Hogg-Dubé syndrome) among patients with spontaneous~     pneumothorax. Patients who were treated for primary spontaneous pneumothorax in Rijnstate~     hospital are to be included. Patients will receive a questionnaire. When given consent, the~     investigators will invite them for a one-time visit to the out-patient clinic. Patients will~     be asked for a blood sample to determine pathogenic FLCN (folliculin) mutations and a~     pulmonary CT scan for evaluation of presence of lung cysts.~   "
49654|NCT02916979|"~     This study is examining a chemotherapy regimen and immune suppressive medications in the~     setting of an allogeneic stem cell transplant. A pilot clinical trial to characterize the~     incidence, prevalence and function of myeloid-derived suppressor cells (MDSCs) and immune~     checkpoint regulators (V-domain Ig Suppressor of T-cell Activation [VISTA], cytotoxic~     T-lymphocyte- associated protein 4 [CTLA-4], programmed death-ligand 1 [PD-L1]) during early~     immune recovery following an allogeneic stem cell transplant. The site will use a~     myeloablative regimen of fludarabine with busulfan, adopted from CALGB 100801, to define~     clinical endpoints, including engraftment, 100 day survival and one year survival (Objective~     #1). The site will characterize the incidence, prevalence and function of MDSCs and immune~     checkpoint regulators in patients' blood and bone marrow following transplantation (Objective~     #2). The site will correlate these laboratory results with clinical outcomes and the~     incidence of graft-versus-host disease (GVHD). As an exploratory aim, in those patients~     experiencing GVHD and requiring treatment, the site will define the MDSCs frequency and~     checkpoint regulator expression and correlate these results with the patient's response to~     GVHD therapy.~   "
49655|NCT02916966|"~     The proposed research is particularly relevant to the National ALS Registry and public~     environmental health issues because it addresses the potential environmental causes of~     sporadic ALS. The research will develop an ALS surveillance program in Ohio that can be~     compared with the national and State-Metro Surveillance Programs of the National ALS~     Registry, and novel methodologies to determine the role of the cyanobacterial toxin, BMAA,~     and other environmental toxicants as risk factors for ALS. This work will advance the mission~     of the CDC ATSDR National ALS Registry by offering data on ALS cases in Ohio that address~     public health concerns over the effects of chronic exposure to cyanobacterial blooms in Lake~     Erie.~   "
49656|NCT02916940|"~     There is currently no real consensus on the optimal management of acute sprains of the~     proximal interphalangeal joint of the long fingers.~      The aim of this study is to assess the beneficial effect of an injection of corticosteroids~     for the treatment of this type of sprain (one single sub-cutaneous injection, in the acute~     phase). This treatment, if effective, might become the treatment of choice for these types of~     injuries, instead of a prolonged immobilization or a careful early mobilization.~   "
49657|NCT02916927|"~     Objective: The purpose of this study is to determine if administering ketamine as an~     intravenous (IV) infusion over 15 minutes, as compared to an IV push, will decrease adverse~     drug reactions without attenuating its analgesic effects.~      Study design: prospective, randomized, controlled, double-blind trial.~   "
49658|NCT02916914|"~     Preterms are usually fed with intervals of either two or three hours during their stay in~     neonatal intensive care unit. Recommendations of World Health Organization about feeding~     regimens, 3-hourly for infants 1500 - 2000 gr, and 2-hourly for infants 1000 - 1500 gr, are~     not proposed with regards to results of randomized controlled trials. Investigators aimed to~     investigate the impact of 2-hourly feeding on time of transition from orogastric to oral~     feeding.~   "
49659|NCT02916901|"~     The purpose of this study is to determine influence of CKD-519 on 24-h ambulatory blood~     pressure after oral administration in healthy adult volunteers.~   "
49660|NCT02916888|"~     The purpose of this study is to investigate the differences in the quality of life of~     patients and caregivers who are treated by general pediatricians versus pediatric~     dermatologists for eczema (atopic dermatitis or AD).~   "
49727|NCT02915991|"~     This is a prospective, single-arm, unblinded, case observation study evaluating a~     commercially released 'Conformité Européenne' (CE)-mark co-registration software system~     along-side of a commercially- released CE-mark coronary physiology and X-ray system during~     routine clinical workflow. The purpose of this study is to collect Professional user feedback~     regarding clinical utility of the SyncVision 4.X system.~   "
49728|NCT02915978|"~     The primary objective of this trial is to evaluate analgesic efficacy of Fentanyl Sublingual~     Spray compared with placebo in participants with postoperative pain after a bunionectomy.~   "
49661|NCT02916875|"~     In 2015 the Danish healthcare authorities initiated major changes in the follow-up (FU)~     program for patients with ovarian cancer. The new FU program argues that there is no effect~     of routine monitoring, and every patient's FU is now individualized. These changes have~     caused major concern, especially regarding the omission of routine examinations aimed at~     detection of recurrence, since clinical symptoms of relapse can be diffuse. Clearly, tools~     and FU plans to support the patients in feeling safe during FU are of vital importance.~      Patient-reported outcome measures (PROM) is a tool to improve the focus on patients' needs,~     symptoms and preferences. It is also a tool to monitor quality of life (QoL), and side~     effects.~      300 patients with ovarian cancer are planned to be enrolled after primary treatment when they~     enter follow-up program. This is a multi-center study.~      All participants fill in a questionnaire at baseline and then every 3 months for two years,~     and every 6 months the third year. The questionnaire consists of EORTC-QLQ-C30, EORTC-OV28,~     and questions on symptoms of relapse. At baseline the questionnaire is extended with~     demographic issues.~      The patients will also fill in a brief questionnaire (CollaboRATE) dealing with patient~     satisfaction and the level of shared decision making experienced.~      All participants are followed for 3 years.~   "
49662|NCT02916862|"~     The primary aim of this proposal is to determine the effects of soluble corn fiber (SCF)~     supplementation for 1 year on bone metabolism in growing adolescents compared to controls.~     For the proposed study, a randomized double-blinded placebo controlled clinical trial will be~     conducted in 168 healthy adolescents aged 11-14 years, equally randomly assigned to one of~     three intervention groups: SCF (12 g/d, administered twice a day), SCF + calcium (12 g/d of~     SCF + 600 mg/d of elemental calcium carbonate, twice a day), or placebo (0 g/d of SCF or~     calcium, administered twice a day). Bone metabolism and bone related biomarkers will be~     assessed at baseline and at 12 months.~   "
49663|NCT02916849|"~     This five arm feasibility study aims to promote self-management in strength and balance~     exercises among community-living older people. The research process, implementation~     strategies and procedures, acceptability of the exercise programs, perceived benefits of the~     programs, and the ecological validity, acceptability and ability to detect change of possible~     outcome measurements will be evaluated before a future randomized controlled trial. A~     comparison of two exercise programs will be performed; a) Safe Step, a mobile technology~     based exercise program with motivational strategies, developed by researchers in~     collaboration with older adults, and b) Otago Exercise Program (OEP), home exercises~     presented in a booklet. The older participants will be free to select either of the~     intervention programs and the selection process and outcome will be studied as part of the~     process evaluation.~      The participants in three of the arms (OEP, Safe Step, and Safe Step with mentors) will be~     recruited through advertisements in local papers and through posters and meetings at senior~     citizens organisations. In the fourth and fifth arms (OEP and Safe Step) the participants~     will be recruited from health care centres and their registered professionals with experience~     of greens prescriptions (Fysisk aktivitet på recept). All five groups, with at least 10~     participants in each, will be exercising for four months and will undergo testing at~     baseline, after two and four months and they will be asked to keep an exercise diary (digital~     or paper format) during the intervention.~   "
49664|NCT02916836|"~     The drug iatrogenesis represents an important public health problem. In the Iatromed project,~     we want to to assess a specific therapeutic drug conciliation sheet (TDC). This multicenter~     observational study is focus on 750 patients aged over 75 year old with polymedication. The~     main objective will be to determine if the use of the TDC, at the discharge of hospital,~     allows to reduce the number of use in emergency care within the two month after their~     hospital discharge~   "
49665|NCT02916810|"~     Neuroimaging studies suggest that aberrant activities at specific brain regions such as~     sensory areas and language-related areas are related to psychosis symptoms including auditory~     and visual hallucination, delusion, and thought disorders. Transcranial magnetic stimulation~     (TMS) provides a non-invasive means for altering brain electrical neural activity. TMS has~     been approved by FDA for treatment of depression. Other applications have not been approved~     but it has been used in a wide range of clinical research especially in neurology and~     psychiatry. Among psychotic symptoms, there are preliminary significant improvement in~     treatments of auditory hallucination using TMS with small samples, but those treatments are~     not robust in larger samples. The high inter-subject variability limits the efficacy of TMS~     treatment in schizophrenia patients. We aim to develop a TMS treatment method with a~     fMRI-defined treatment target area, where the TMS target is individually identified to~     maximize the TMS effects. The identification method uses both the anatomical character and~     its functional relationship with auditory hallucination and other psychosis symptoms. If the~     current target-identification successfully identified effective TMS target individually, the~     treatment efficacy will be significant improved and more patients will benefit from TMS~     treatment.~   "
49666|NCT02916797|"~     -  Are there differences in immediate effects of stepping training with and without the use~          of visually weight-taking machine (VWTM) on variables relating to well-controlled~          walking and walking symmetry in ambulatory patients with stroke?~        -  Are there differences of 4-week stepping training with and without the use of VWTM on~          variables relating to well-controlled walking and walking symmetry in ambulatory~          patients with stroke?~   "
49667|NCT02916784|"~     1. Were there differences in functional ability between ambulatory individuals with SCI who~          passed and failed the independent sit-to-stand (iSTS) task?~        2. Did the ability of iSTS relate to ability of walking as determined using a type of AAD~          used?~        3. What were factors associated with the ability of iSTS?~   "
49668|NCT02916771|"~     This research study is evaluating a new drug called ixazomib as a possible treatment for~     Smoldering Multiple Myeloma.~   "
49669|NCT02916758|"~     This study evaluates the program outcomes of the Let's Go program. The standardized community~     mobility program employs multi-modal group and individual sessions to facilitate wellness in~     older adults.~   "
49670|NCT02916745|"~     This research study is being conducted to assess the safety and feasibility of using a new~     developed bronchoscopic technology called electronavigational bronchoscopy to treat subjects~     with solid tumor in peripheral lung, who are inoperable or refused surgery. It will involve~     10 sites in USA and Canada. Participation will last 6 months.~   "
49672|NCT02916719|"~     Magnetic resonance imaging (MRI) is the method of choice in breast cancer to perform the~     loco-regional staging and direct the treatment.~      European Guidelines (EUSOMA) currently recommend MRI for initial evaluation and assessement~     of the neoadjuvant chemotherapy (NAC) response, for breast cancer. The standard of care~     consists of realizing a MRI before the start of the NAC and another one after it's ended, six~     months later.~      There is currently no consensus on the realization of an interval MRI for early assessment of~     the chemosensitivity of the tumor. It would allow though alterations in the therapeutic~     regimen in the event of a non response. Similarly, there is no consensus on when this~     interval MRI should be performed.~      Some recent studies suggest that Diffusion-weighted Magnetic Resonance Imaging is interesting~     for the evaluation of the early response. However, these are preliminary studies with~     quantitative measures realized by the region of interest (ROI) method. A response to~     neoadjuvant chemotherapy results in elevated values of apparent diffusion coefficients (ADC).~      There is'nt any published data on the potential interest of breast MRI after a radiotherapy~     treatment and before the surgical treatment.~      Therefore, the expected benefits of this study are:~        -  to monitor the early modifications of the perfusion and diffusion parameters at the~          level of the tumor after radiotherapy, and correlate them to the histology of the~          surgical monster.~        -  to assess if MRI is able to objectivate the early signs of response after a radiotherapy~          neo-adjuvant treatment of breast cancer.~      This record is linked to the NCT02858934 record and will share the same cohort of patients~   "
49673|NCT02916706|"~     This study is designed as a prospective, multi-centre, parallel group, double-blind~     randomized, placebo-controlled, phase 3 clinical study to evaluate the efficacy and safety of~     MP-513 (Teneligliptin).~   "
49674|NCT02916693|"~     The only class of oral erectile dysfunction (ED) medication on the market are the~     phosphodiesterase Type 5 inhibitors (PDE5i). This pilot study is being done to evaluate the~     effect of Mirabegron, an oral beta-3 adrenergic agonist, on men with both Overactive Bladder~     (OAB) symptoms and mild to moderate ED.~   "
49675|NCT02916680|"~     The overall objective is to establish that transplantation of allogeneic pancreatic islet~     cells into the anterior chamber of a severely visual impaired diabetic human eye is safe and~     does not cause ophthalmic or systemic complications. Furthermore, the change in insulin~     production, glucose control and hypoglycaemia awareness will be assessed.~   "
49676|NCT02916667|"~     Working hypothesis and aims:~      To asses Chrono Biological factors during the third trimester of gestational diabetes~     melittus (GDM) with birth weight and related complications. The investigators hypothesize~     that participants with GDM pregnancies with higher Chrono Biologocal status will be ended~     with higher birth weight compared to participants with GDM pregnancies with lower status. In~     addition, the investigators hypothesize that the Chrono Nutritional intervention program will~     contribute to the reduction of the rate of birth weight above percentile 90 compared with the~     participants with GDM in the control group.~   "
49677|NCT02916654|"~     Sucrosomial iron (Sideral® Forte) is a preparation of ferric pyrophosphate conveyed within a~     phospholipid membrane associated with ascorbic acid, is a new-generation oral iron which~     shows a high gastrointestinal absorption and high bioavailability with a low incidence of~     side effects due to lack of any direct contact with intestinal mucosa. In comparison with the~     other standard oral iron preparations, sucrosomial iron seems to be a promising new strategy~     of iron replacement in CD patients.~   "
49678|NCT02916641|"~     Ursodeoxycholic acid (UDCA) has been the only treatment for PBC approved by US and European~     drug administrations. Long-term use of UDCA(13—15 mg/kg/day) in patients with PBC improves~     serum liver biochemistries and survival free of liver transplantation However, about 40% of~     patients do not respond to UDCA optimally as assessed by known criteria for biochemical~     response. Those patients represent the group in need for additional therapies, having~     increased risk of disease progression and decreased survival free of liver transplantation.~     And UDCA has less effect on PBC patients whose pathology stage 3-4. Liver fibrosis might~     jeopardize the UDCA effect. Fuzhenghuayu is a Chinese traditional medicine for liver fibrosis~     and cirrhosis. Both lab research and some clinical studies suggest that Fuzhenghuayu could~     significantly reverse liver fibrosis and cirrhosis due to different kind of etiology. Here we~     start a random, open and parallel clinical research to explore the effect of Fuzhenghuayu~     combined with UDCA in the PBC treatment.~   "
49679|NCT02916628|"~     Objective The purpose of this study is to examine the effects of auricular acupressure and~     group counseling with positive psychology and motivational interviewing on smoking cessation~     and tobacco withdrawal symptoms.~      Methods This study is a single blind randomized controlled trial. This study has been~     performed at a University in South Korea. 180 smokers and 60 non-smokers will be recruited.~     Smokers will be randomly assigned to three groups: group 1 (auricular acupressure + group~     counseling); group 2 (placebo acupressure + group counseling); and the control group~     (self-help smoking cessation). Group counseling is undertaken once per week for 6 weeks.~     Auricular acupressure using acupellets is performed for 6 weeks continuously.~   "
49680|NCT02916615|"~     The purpose of this study is to examine the effect of different vegetables on cardiovascular~     function in subjects with moderately increased blood pressure. Specifically we are comparing~     the effects of vegetables with a high natural content of inorganic nitrate with those of~     vegetables with a low nitrate content.~   "
49681|NCT02916602|"~     A phase 3 study to evaluate efficacy and safety of HCP1401~   "
49729|NCT02915965|"~     The purpose of this study is to determine whether docetaxel, cisplatin, and capecitabine~     (DCX) are effective as the neoadjuvant chemotherapy before esophagectomy in patients with~     loco-regional esophageal squamous cell carcinoma (ESCC).~   "
49730|NCT02915952|"~     The study will evaluate the ZipLine Medical Surgical Skin Closure device (Zip)versus sutures~     when utilized for skin layer closure during wound closure of Cesarean Section Procedure.~   "
49743|NCT02915783|"~     This is a single-arm, multicenter, Phase 2 study of lenvatinib in combination with everolimus~     in participants with unresectable advanced or metastatic non clear cell renal cell carcinoma~     (nccRCC) who have not received any chemotherapy for advanced disease. The primary objective~     of the study is to evaluate the objective response rate (ORR). This study consists of three~     phases: a Pretreatment Phase (Screening and Baseline Periods), a Treatment Phase (starting~     Cycle 1, Day 1), and a Posttreatment Phase (End of Treatment Visit and survival Follow-up).~   "
49682|NCT02916589|"~     Obesity continues to pose major public health challenges worldwide with cardiovascular~     damage, hypertension and diabetes as possible subsequent conditions. The obese are at risk~     for mortality and morbidity as they suffer from a high level of immune sensitivity with~     consequences related to damage to the circulation and microvasculature. The immune process~     itself is modulated by cytokines, which are small proteins which can modulate the spectrum of~     the inflammatory process. These proteins may act as biomarkers in the mouth.~      Diabetes is also a consequence of sustained obesity and this condition can strongly influence~     immune status. Diabetes is characterized by the failure to produce the hormone insulin or a~     loss of sensitivity to insulin. Without insulin high blood glucose results in the release of~     a series of pro-inflammatory factors, which lead to pathological processes in several organs~     leading to high mortality and morbidity. Periodontitis, a common complication of diabetes, is~     an inflammatory condition of the soft tissue of the periodontium, causing alveolar bone loss.~     The accessibility of the oral cavity facilitates the study of early inflammatory processes.~      Changes in diet may reduce inflammation, controlling gingival inflammation as well as~     clinical treatment. Since 2004 Igelösa Life Science AB has developed a modified Nordic diet~     based on evidence, primarily from the Japanese island of Okinawa, where the world's oldest~     and most healthy people live. In this study we will investigate the association between~     Igelösa dietary intake and measurements of inflammation in 30 overweight individuals with or~     without other systemic diseases.~   "
49683|NCT02916576|"~     The user performance evaluation shows whether people with diabetes are able to obtain~     accurate measurement results with a blood glucose monitoring system. In this study, user~     performance evaluation will be performed for Contour Plus One (Ascensia Diabetes Care GmbH),~     Accu-Chek Performa Connect (Roche Diabetes Care GmbH), FreeStyle Optium Neo (Abbott Diabetes~     Care Inc.), OneTouch Select Plus (LifeScan Europe) based on ISO 15197:2013; EN ISO~     15197:2015, clause 8.~      For each BGMS, measurement procedures for user performance evaluation will be performed with~     1 test meter and 1 reagent system lot by the study subjects.~      The same meter and an additional test meter will be used for double measurements performed by~     study personnel (with the same reagent system lot used by subjects).~   "
49684|NCT02916550|"~     This study examines the impact of a breathing training intervention on cardiorespiratory~     sensations and anxiety in adults with cardiac arrhythmias.~   "
49685|NCT02916537|"~     The purpose of this study is to test a novel diagnostic Positron Emission Tomography (PET)~     imaging agent for safety and biodistribution. The agent binds Prostate Specific Membrane~     Antigen (PSMA) and is designed to detect prostate tumors.~   "
49686|NCT02916524|"~     The purpose of this investigation is to implement a computational model that can predict and~     optimize training and cross-language generalization patterns for bilingual persons with~     aphasia (BPA). The proposed work will determine the best possible treatment program for each~     individual patient even before they are rehabilitated. In addition, the computational model~     allows specification of variables such as age of acquisition, language exposure/proficiency,~     impairment and their systematic influence on a range of language rehabilitation outcomes.~   "
49687|NCT02916511|"~     The purpose of this study is to evaluate safety and 2-year local control rate for extensive~     clinical target volumes in postoperative radiotherapy concurrent with chemotherapy for~     esophageal squamous cell carcinoma.~   "
49688|NCT02916498|"~     The study aims to better understand how to program Spinal Cord Stimulation for the treatment~     of chronic low back and leg pain~   "
49689|NCT02916485|"~     Assessment of the clinical performance and the safety of the Magmaris Sirolimus-Eluting~     Resorbable Coronary Magnesium Scaffold in a cohort of patients in India with de novo coronary~     artery lesions.~   "
49690|NCT02916472|"~     Only a few clinical trials evaluating the potential benefits of exercise have been conducted~     in adolescents and young adults (AYA) with cancer and, no prior studies have evaluated the~     potential effects of 'cybercycling' (exergaming on a stationary bike) in AYA cancer~     survivors. Therefore, the study aims to conduct a pilot trial to determine feasibility~     (adherence, user acceptance) and to explore potential effects of a 'cybercycling' exercise~     program on fitness, body composition, quality of life, sleep and cognition.~   "
49691|NCT02916459|"~     This is a prospective randomised diagnostic clinical study to determine whether the use of a~     new flexible sampling needle can improve the yield of endobronchial ultrasound guided~     transbronchial needle aspiration (EBUS-TBNA). Patients undergoing EBUS-TBNA for clinical~     reasons as deemed necessary by the managing physician or multidisciplinary team will be~     randomised to undergo either EBUS-TBNA or Flex 19G EBUS-TBNA. The procedure will be performed~     under local anaesthesia using conscious sedation or general anaesthesia according to usual~     practice at the trial centre. Specimens will be placed in saline and formalin and forwarded~     to the pathology laboratory. The specimens will be spun down to create a cell pellet which~     will undergo cytological and histological examination as per usual protocol at the trial~     centre.The pathologist, who will be blinded as to which technique was used to obtain the~     sample, will grade the quality, quantity, and cellularity of the specimens.~   "
49692|NCT02916446|"~     This study evaluates the safety of Viaskin Peanut 250 mcg in the treatment of peanut allergy~     in children from 4 to 11 years of age. Subjects will receive either Viaskin Peanut 250 mcg or~     a placebo for a period of 6 months, after which all subjects will be receiving the active~     treatment up to a period of 3 years under active treatment.~   "
49731|NCT02915939|"~     Emerging research on family caregiving and institutionalization has emphasized that families~     do not disengage from care responsibilities following a relative's admission to residential~     long-term care settings. The Residential Care Transition Module (RCTM) provides 6 formal~     sessions of consultation (one-to-one and family sessions) over a 4-month period to those~     family caregivers who have admitted a cognitively impaired relative to a residential~     long-term care setting (nursing home, assisted living memory care unit). The proposed mixed~     method, randomized controlled trial will determine whether and how the RCTM decreases family~     caregivers' emotional and psychological distress, placement-related strain, and increases~     relative's transitions back to the community. The RCTM will fill an important clinical and~     research gap by evaluating a psychosocial intervention designed for families following RLTC~     placement to determine whether and how this approach can help families better navigate the~     residential care transitions of relatives with Alzheimer's disease or a related dementia.~   "
49693|NCT02916433|"~     This study is an open-label, randomized controlled trial. Patients will be randomized into~     two groups of 15, Routine Care group, which will serve as the control group, and~     Octreotide group. The amount of bronchial secretions is routinely measured in all~     mechanically ventilated patients. Once the Primary Team identifies a patient as a candidate~     for the study (based on the inclusion and exclusion criteria) and an informed consent has~     been obtained, the baseline volume of bronchial secretions per 12-hour period will be~     recorded and a security envelope containing group assignment will be opened by the ICU~     attending. Both groups will continue to receive treatments that have already been initiated~     to manage bronchial secretions. In addition, Octreotide group will receive parenteral~     octreotide, while Routine Care group will receive care as deemed necessary by the Primary~     Team. The rate of bronchial secretions will be measured and recorded daily; the changes,~     relative to the baseline measurements, will be compared between the groups. These~     interventions will be continued for 72 hours or until extubation or withdrawal from the~     study, whichever occurs earlier. Subsequently, the standard of care management, as determined~     by the Primary Team, will be resumed.~   "
49694|NCT02916420|"~     This study aims to assess the efficacy and safety of pomalidomide in combination with~     low-dose dexamethasone in Chinese patients with relapsed and refractory multiple myeloma.~   "
49695|NCT02916407|"~     The investigators evaluate extubation time and recovery profiles in children undergoing~     entropion surgery.~   "
49696|NCT02916394|"~     The investigators developed [68Ga]-labelling Anti-IGF-1R Affibody Molecule as a targeted~     molecular imaging agent for noninvasive and repeatable detecting IGF-1R expression status.~   "
49697|NCT02916381|"~     Unilateral mastectomy is associated with moderate to severe postoperative pain. A new~     regional anaesthetic technique has been recently described, call the PEC block. This~     technique consists of injecting local anaesthetic between different muscles of the chest in~     order to relieve postoperative pain. The investigators aim to verify that this technique has~     a clinical relevant postoperative analgesic effect. For that purpose, the investigators will~     randomise 50 patients scheduled to undergo unilateral mastectomy into two groups: one group~     will receive a PEC block after the induction of the general anaesthesia under ultrasound~     guidance, while the other group will not have this regional procedure.~   "
49698|NCT02916368|"~     Head and neck Squamous Cell Carcinoma (HNSCC) is one of the most common head and neck~     malignant tumors .Investigators found that several patients with early TNM stage and poor~     differentiated HNSCC had poor prognosis, yet someone with advanced TNM stage and well~     differentiated HNSCC had good prognosis. Hence, Investigators suggested that prognosis~     factors and survival rates probably related to the differentiation of HNSCC, and prognosis~     factor of poorly differentiated HNSCC were rare discussed and controversy. Investigating the~     prognostic factors of poorly differentiated HNSCC is undoubtedly crucial.~   "
49699|NCT02916355|"~     Role of IL-1 in postprandial fatigue - The Chäschüechli 2 Study It is a randomized, single~     dose, placebo-controlled, double blind, cross-over, proof-of-concept study.~      16 healthy young men will be included in this study. The objective of this study is to~     evaluate if severity of postprandial fatigue is driven by IL-1.~      Since fatigue is associated with increased cytokine levels, and since fatigue in chronic~     inflammatory settings, such as type 2 diabetes, can be reduced by inhibition of IL-1β,~     postprandial fatigue might also respond to anti-inflammatory intervention with IL-1~     inhibition.~      The aim of the study is to investigate whether postprandial fatigue is, at least in part,~     driven by the IL-1 system.~   "
49700|NCT02916342|"~     The interscalene block provides effective analgesia after shoulder surgery. It consists of~     injecting local anaesthetic within the brachial plexus, in the interscalene groove, between~     the anterior and middle scalene muscles. Unfortunately, this technique is associated with~     respiratory complications such as hemidiaphragmatic paresis due to the spread of the local~     anaesthetic towards the phrenic nerve that lies close to the brachial plexus, with an~     incidence up to 100%. The diaphragmatic paresis may be a serious side-effect, especially in~     patients suffering from a reduced respiratory function such as chronic obstructive pulmonary~     disease; this entity may even represent a contraindication to the performance of the block.~      The shoulder is mainly innervated by the suprascapular and axillary nerves, both of them~     coming from C5 and C6 branches of the brachial plexus block. Recently, several authors have~     successfully identified and block these two nerves under ultrasound guidance. Only one~     randomised controlled trial compared interscalene block with a combination of suprascapular~     and axillary nerve blocks, and showed inconclusive results probably due to the absence of~     ultrasound guidance; indeed, analgesia was equivalent at the sixth postoperative hour, while~     patients with an interscalene block had reduced pain scores in the recovery room. Besides,~     the authors did not investigate the impact on the respiratory function.~      In that randomised controlled trial, the investigators would like to compare the analgesic~     efficacy and the respiratory outcomes between the interscalene block and the combined~     suprascapular-axillary nerve blocks.~   "
49701|NCT02916329|"~     The investigators developed [68Ga]-labelling Anti-EGFR Affibody Molecule as a targeted~     molecular imaging agent for noninvasive and repeatable detecting EGFR-ECD expression status.~   "
49702|NCT02916316|"~     All patients enrolled in the study will have to be treated with a chemo immunotherapy scheme~     R-CHOP with doxorubicin, with doxorubicin analogue or non pegylated liposomal anthracycline~     (R-COMP; Sec. 648 DM) administered every 21 days for 6 cycles. In unfavourable patients~     (stage II-IV) are allowed 2 additional cycles of rituximab at the end of the 6 cycles of~     R-CHOP.~   "
49732|NCT02915926|"~     A single-blind Randomized Controlled Trial will be used to test the efficacy of the OPC on~     self-efficacy and occupational performance with mothers of children with cerebral palsy.~     Canadian Occupational Performance Measurement and Sherer general self-efficacy scale will be~     employed to data collection. The sample size was determined for each group of 15 people. The~     participants conveniently and according to inclusion and exclusion criteria will be~     randomized into the groups. Participants in the intervention group will be participated in 10~     sessions of OPC. At the end the questionnaires will be completed by both groups.~   "
49733|NCT02915913|"~     The BrainFit Study aims to examine acute effects of High Intensity Interval- vs Resistance or~     Combined program has benefits on Cognitive Function as well as on secretion and regulation of~     neurotrophic factors or neurotrophins in a cohort of sedentary, overweight adults (aged 18-30~     years) from Bogota, Colombia.~   "
49703|NCT02916303|"~     Schizophrenia has very significant economic consequences. Costs fall on many different parts~     of society, especially on individuals with schizophrenia and their families. The first five~     years after onset appears to be a critical period in which the symptoms are more responsive~     to treatment. In addition, if left untreated for a long time, psychosis can impact many areas~     of a person's life. The evidence base regarding the effectiveness of specialist early~     intervention services for psychosis has grown steadily and evidence from randomized~     controlled trials in Denmark, the United Kingdom and Spain has demonstrated the superiority~     of specialized early intervention programs over standard care on a broad range of outcomes~     including symptomatic and vocational, social functioning, and reduced inpatient care and~     treatment dropout, as measured over follow-up intervals of 2-3 years. Information about the~     cost-effectiveness of early intervention programs for first-episode psychosis is limited. The~     provision of such services requires investment by health departments and services, and the~     question of whether such services represent value for money has to date received little~     research attention. Only a few international studies, and none conducted in Spain, have~     investigated the cost effectiveness of early intervention in psychotic disorders at medium (3~     years) and long-term (up to 10 years). In this study, the investigators aimed to analyse the~     cost-effectiveness of an intensive early-intervention programme, using data from First~     Episode Psychosis Clinical Program (PAFIP), the largest trial treating first episode~     non-affective psychosis in Spain to date.~   "
49704|NCT02916290|"~     Ursodeoxycholic acid (UDCA) has been the only treatment for PBC approved by US and European~     drug administrations. Long-term use of UDCA (13—15 mg/kg/day) in patients with PBC improves~     serum liver biochemistries and survival free of liver transplantation.~      However, about 40% of patients do not respond to UDCA optimally as assessed by known criteria~     for biochemical response. Those patients represent the group in need for additional~     therapies, having increased risk of disease progression and decreased survival free of liver~     transplantation. And UDCA has less effect on PBC patients whose pathology stage 3-4. Liver~     fibrosis might jeopardize the UDCA effect. Fuzhenghuayu is a Chinese traditional medicine for~     liver fibrosis and cirrhosis. Both lab research and some clinical studies suggest that~     Fuzhenghuayu could significantly reverse liver fibrosis and cirrhosis due to different kind~     of etiology. Here the investigators start a random, open and parallel clinical research to~     explore the effect of Fuzhenghuayu combined with UDCA in the PBC treatment.~   "
49705|NCT02916277|"~     In this study; in patients undergoing mechanical ventilation, making the day series Endocan~     measurements during the first 5 day to look at whether there is a relationship between the~     levels of VAP with Endocan. This relationship, if any, aimed to investigate whether~     correlated with clinical and laboratory findings [presence of fever, pathological lung X-ray,~     the number of white blood cells (WBC), procalcitonin (PCT), C-reactive protein (CRP)] .~   "
49706|NCT02916264|"~     It is a randomized control trial to compare the surgical plethysmographic index (SPI)~     response during a Mayfield head-holder insertion in neurosurgical patients who receive a~     scalp block versus those who do not receive the scalp block after induction of anesthesia~     with propofol with fentanyl and intubation with cis-atracurium.~   "
49707|NCT02916251|"~     The trial is a single-centre, randomised, sequential, cross-over trial assessing~     pharmacokinetic and pharmacodynamic responses after micro-doses of ZP4207 (dasiglucagon*)~     administered subcutaneously to patients with type 1 diabetes mellitus under euglycaemic and~     hypoglycaemic conditions and compared to marketed glucagon.~      *dasiglucagon is the proposed International Nonproprietary Name (pINN) for ZP4207~   "
49708|NCT02916238|"~     Depression is often the most prevalent mental health problem among people living with HIV~     (PLWH) worldwide, and if not adequately treated, it may impair response to antiretroviral~     treatment (ART) and the ability of individuals to adhere to medications and healthy behavior.~     Most patients with depression receiving ART in the poorest countries of the world are left~     untreated because no systematic approach or expertise is available. This study adapts an~     evidence-based model of depression care (Measurement-Based Care - MBC) using auxiliary HIV~     clinic staff, and tests feasibility and assesses costs among HIV positive patients beginning~     ART in Port-au-Prince, Haiti.~   "
49709|NCT02916225|"~     The purpose of this study is to determine whether high intensity interval training (HIIT) is~     superior to moderate continuous training in increasing cardiopulmonary capacity in heart~     failure with preserved ejection fraction patients.~   "
49710|NCT02916212|"~     This project aims to reduce the frequency of duplicate, false and clinically insignificant~     alarms in hospital units, and subsequent alarm fatigue resulting from excessive alarm~     frequency. The investigators will implement evidence-based guidelines for alarm optimization~     according to patient-population specific parameters, and evaluate alarm frequency and staff~     perception of alarm fatigue at baseline and 60 days after implementation of this quality~     improvement initiative.~   "
49711|NCT02916199|"~     The aim of this study are to evaluate the feasibility of needle knife fistulotomy (NKF) as an~     initial procedure for biliary access in patients with biliary disease who are at increased~     risk for post-endoscopic retrograde endoscopic retrograde cholangiopancreatography (PEP) and~     to assess the incidence rate of complications including PEP between NKF and conventional~     cannulation methods.~   "
49712|NCT02916186|"~     The goal of the present study is to compare the amount of root coverage resulting from~     subepithelial connective tissue graft and acellular dermal matrix associated with tunnel~     technique among patients suffering from multiple gingival recession.~   "
49713|NCT02916173|"~     The follicular phase of the menstrual cycle involves the hourly release of~     gonadotropin-releasing hormone, which binds to receptors on the gonadotropes. This results in~     the secretion of follicle stimulating hormone and luteinizing hormone in hourly pulses that~     regulate follicular growth. At midcycle, rapidly rising estradiol from the dominant follicle~     and a small rise in progesterone lead to a gonadotrophic surge. An increase in the amplitude~     of Luteinizing hormone and Follicle stimulating hormone pulses initiates oocyte maturity and~     triggers ovulation approximately~   "
49744|NCT02915770|"~     This study evaluates the clinical application of cholangiojejunostomy in the surgical~     treatment of cholelithiasis with Moderate dilatation of common bile duct. Half of~     participants will receive hepatectomy, cholangiojejunostomy and T-tube Drainage, while the~     other half will receive hepatectomy and T-tube Drainage.~   "
49714|NCT02916160|"~     Chronic Heart Failure (CHF) is a frequent pathology burdened with mortality and significant~     morbidity. Sleep apnea syndrome (SAS) is frequently associated with CHF in 20% to 75% of~     cases. Treatment of SAS is however inconsistently associated with a decline in the morbidity~     and mortality. To date, the CHF medical treatments have been reported to be inconsistently~     efficient in the treatment of SAS.~      SACUBITRIL-VALSARTAN (ENTRESTO®) is a new treatment of CHF recently indicated class I, level~     B in the recent European Society of Cardiology (ESC) guidelines 2016 on CHF. PARADIGM-HF~     trial demonstrated that morbidity and mortality can be improved with SACUBITRIL-VALSARTAN. In~     comparison to enalapril, it reduced the occurrence of cardiovascular death or hospitalisation~     for CHF by 20% with a 16% reduction in all-cause mortality.~      The purpose of the research is the evaluation of SACUBITRIL-VALSARTAN combination in CHF~     patients presenting sleep apnea syndrome. A three months real life observational trial is~     performed. A measure of the Apnea Hypopnea Index is realised before and after 3 months of~     SACUBITRIL-VALSARTAN treatment. A concomitant evaluation of cardiological and quality of life~     parameters is realized.~   "
49715|NCT02916147|"~     This study aim to observe and compare the change of alarmins such as high mobility group~     nucleosome-binding protein-1 (HMGN1), high mobility group proteins b1 (HMGb1), Interleukin~     (IL)-33 and their soluble receptors including soluble toll like receptor 4 (sTLR4) and~     soluble ST2 (sST2) during pulmonary lobectomy for cancer patients receiving volatile~     anesthesia or intravenous anesthesia under one-lung ventilation (OLV). By which, this study~     will preliminarily evaluate the correlation of alarmins and prognosis as well as the effect~     of inhalational and intravenous anesthesia on the prognosis of surgical patients.~   "
49716|NCT02916134|"~     This study aims to compare antibiotic treatment versus surgery for patients with~     uncomplicated appendicitis.~   "
49717|NCT02916121|"~     The investigators study aims are:~        1. To investigate folate, vitamin B12, and homocysteine levels in patients with~          schizophrenia.~        2. To evaluate the relationships among folate, vitamin B12, and homocysteine levels,~          genetic variants of one-carbon cycle pathway, psychopathology, including positive~          symptoms, negative symptoms, and cognition, and metabolic abnormalities in patients with~          schizophrenia.~        3. For patients with low folate levels, the investigators would like to conduct a 24-week~          double-blinded, placebo-controlled of folic acid (5 mg/d) and vitamin B12 (500 ug/d)~          supplementation study to know whether combination of folic acid and vitamin B12 can~          improve patients' psychopathology or metabolic profiles, and the effects of genetic~          variants in one-carbon cycle pathway on treatment response.~   "
49718|NCT02916108|"~     Approximately 150,000 children present each year to emergency departments (EDs) in the US~     with concussion and many more are treated by primary care physician, or outpatient~     specialists.~      Concussion is defined as a traumatically induced transient disturbance of brain function and~     involves a complex pathophysiological process. There is a variety of symptoms related to~     concussion, and the diagnosis of concussion requires the use of symptom-checklist. Since~     there is a various degree of the severity of those symptoms, the diagnosis is a subjective~     one and lacks sensitivity.~      One major problem is that approximately one-third of the children with concussion experience~     ongoing somatic, cognitive, and psychological or behavioral symptoms, referred to as~     persistent post-concussion symptoms. A recent study that investigated the validity a 12-point~     PPCS risk score revealed that it had modest validity (0.71). Moreover, one of the greatest~     concerns is the child's schedule return to activity.~      Since the basic mechanism for concussion is acceleration/ deceleration movement of axons, it~     is likely to be expressed in desynchronization of delta wave activity between anterior~     hemispheres as seen in pathological problems related to attention and/ or working memory).~      The aim of this proof-of-concept study is to find-out whether interhemispheric~     desynchronization of delta waves (IHDD) in the anterior hemispheres can identify acute~     concussion in children. If the investigators find that IHDD can accurately diagnose acute~     concussion, a second objective will be to examine whether this index can be a useful tool in~     the follow up of patients with persistent post-concussion symptoms.~   "
49719|NCT02916095|"~     The purpose of this study is to evaluate the safety , tolerability, pharmacokinetics of~     Kanitinib and determine the optimal dose in patients with recurrent or metastatic solid~     tumors.~   "
49720|NCT02916082|"~     To evaluate the value of measuring cervical length as a predictor of vaginal birth after~     induction of labor with prostaglandins in pregnancies with 41 weeks of gestation.~   "
49721|NCT02916069|"~     Multimodal brain monitoring is feasible and can be used in formulating therapeutic strategies~     during cardiac surgery. Such monitoring may help to improve patient outcome and to reduce~     costs after cardiac surgery with CPB.~   "
49722|NCT02916056|"~     This is an open-label extension study in patients with mild Alzheimer's disease who have~     completed participation in the azeliragon Phase 3 (STEADFAST) trial. Patients will receive~     azeliragon 5 mg/day for up to 2 years.~   "
49723|NCT02916043|"~     Cell-count related risk factors for acute kidney injury after cardiovascular surgery have~     been reported. The authors attempted to investigate whether the perioperative cell counts of~     neutrophil, lymphocyte, platelet are associated with the postoperative acute kidney injury~     and long-term mortality after cardiovascular surgery using cardiopulmonary bypass.~   "
49724|NCT02916030|"~     Stroke remains one of the most devastating neurological diseases, often causing death, or~     gross physical impairment. It is the second most common cause of death worldwide and a major~     cause of acquired disability in adults.Vitamin D deficiency has been reported to contribute~     to the risk of cardiovascular disease especially stroke.~   "
49725|NCT02916017|"~     This study evaluates the long- term safety and effectiveness of adalimumab in participants~     with non-infectious intermediate-, posterior-, or pan-uveitis in daily practice in Japan.~   "
49726|NCT02916004|"~     The aim of the study was to describe the feasibility of the nociception flexion reflex and~     the pupillary dilatation reflex as objective pain assessment tools in the Intensive Care Unit~     (ICU). Furthermore to describe the relationship between the responses and the standard of~     care pain evaluation in the critically ill sedated patients.~      Patients were under propofol / remifentanil or propofol / sufentanil sedation protocol during~     measurements in a stair-case increasing intensity model of standardized stimulations.~     (Stimulation intensity are similar to the stimulations of neuromuscular blocking agents~     monitoring.)~   "
49734|NCT02915900|"~     During in vitro fertilisation (IVF) treatment, women receive hormone stimulation with~     gonadotropins to induce growth of several ovarian follicles. Selecting the optimal dosage of~     gonadotropin is important to avoid maturation of too few or too many follicles, which may~     impair the chances of treatment success, lead to treatment cancellation, or serious side~     effects.~      Motivated by the lack of standardised procedures to estimate the optimal dosage of~     gonadotropins, a patient-specific test has been developed to predict the optimal hormone~     dosage. By measuring internalisation of gonadotropin by the patient's monocytes isolated form~     the peripheral blood ex vivo, the Gonadotropin Removal Test determines whether a patient~     needs increased or reduced hormon doses.~      In this clinical study the investigators compare deviation from optimal outcome at oocyte~     pick-up day in two patient groups. Optimal outcome of stimulation is defined as 10 oocytes~     collected in the group of patients matching the inclusion criteria of the study.~      The control group receives starting hormone dosage assigned by the clinician according to~     standard clinical procedures. The intervention group receives starting hormone dosage~     adjusted according to the results of the Gonadotropin Removal Test.~   "
49735|NCT02915887|"~     Objective: This study examined the effects of elastic tape applied to the neck on patients~     experiencing chronic neck pain.~      Background: Neck pain is often persistent or recurrent. Various treatments have been~     described, including exercises and manual therapy. Taping is commonly used clinically in the~     management of neck pain, however research in this field is sparse.~      Methods: Elastic tape was applied over the posterior cervical extensor muscles from insertion~     to origin on patients experiencing chronic neck pain. Patients were assessed pre-taping,~     immediately post-taping, and one week post-taping and did not receive additional~     physiotherapy during the study.~      Subjective measures included the Visual Analogue Scale (VAS) for pain intensity, the Neck~     Disability Index (NDI) to determine the level of disability in daily living, and the Tampa~     Scale of Kinesiophobia (TSK) to assess fear of movement or re-injury. Objective outcome~     measures included cervical range of motion, velocity, smoothness, and accuracy of cervical~     motion. These kinematic measures were collected using a customised virtual reality system~     designed to evaluate neck motion disorders.~   "
49736|NCT02915874|"~     The goal of this study is to evaluate the effectiveness of a brief, intensive 1-day~     psychotherapy group intervention (Acceptance and Commitment Therapy, ACT), compared to a 12~     week time control group on anxiety symptoms, vascular function, inflammation, muscle~     sympathetic nerve activity (mSNA), and oxidant stress. Similar measures will be performed at~     baseline in individuals with low or no anxiety for comparison. Individuals who are interested~     in the study will be identified by an online screening survey and will be contacted by the~     research team; advertisements, flyers and mass emails will direct individuals to the online~     screening survey. Those deemed eligible to participate will be randomized to the ACT~     intervention or a control group. Assessments of anxiety symptoms (via various surveys) and~     vascular function (via non-invasive, well-established techniques) will be performed at~     baseline and 12 weeks post-ACT group intervention session. In addition, reassessment of~     anxiety symptoms via aforementioned surveys will take place 6 weeks post-ACT group session.~     After 12 weeks, anxiety and vascular assessments will be repeated to re-evaluate severity of~     anxiety symptoms, vascular function, inflammation, and oxidant stress.~   "
49737|NCT02915861|"~     This is an observational study of patients with scrub typhus (rapid diagnostic~     test/quantitative polymerase chain reaction (RDT/qPCR) positive) and an inoculation eschar~     present on examination, recruited from Chiangrai Prachanukroh Hospital, North of Thailand.~      In this study, we aim to:~        -  Investigate relevant pathogen dissemination dynamics, early innate immune response, and~          pathogen-host interactions in scrub typhus using a minimal set of easily accessible~          samples; the inoculation eschar (crust or biopsy), whole blood and - where possible - a~          lymph node fine-needle aspiration (FNA).~        -  Determine the potential use of the inoculation eschar for improving early diagnostics~          and assessing the diversity of human pathogenic strains; by evaluating non-invasive~          swabs and scrapings, as well as biopsies for molecular diagnostics templates.~        -  Dissect the underlying patho-biology associated with the inoculation eschar and in a~          subgroup, including the draining lymph node; by defining the spectrum of infected cells~          via microscopy and double-immune labeling; by determining cytokine and RNA gene~          expression profiles in blood peripheral blood mononuclear cell (PBMCs) and eschar~          samples.~   "
49738|NCT02915848|"~     Movement disorders such as Parkinson Disease, dystonia, and tremor are related to~     abnormalities of part of the brain known as the basal ganglia. Recently, it has been~     suggested that the basal ganglia works by oscillations (group of neurons cycle between~     activation/deactivation when stimulated) of electrical signals. A treatment that involves~     insertion of electrodes in the subthalamic nucleus (STN) for electrical stimulation, known as~     deep brain stimulation (DBS), is an established treatment for advanced Parkinson's disease.~     However its mechanism of action is still not completely understood. Currently, DBS utilizes~     an open loop system whereby the stimulation settings are manually adjusted depending on the~     patients' clinical response.~        1. Determine whether the local field potential (LFP) recorded from the STN is stable over a~          1.5 year period.~        2. Address whether STN LFP is a suitable control signal, and how it should be used to~          change DBS parameters~   "
49739|NCT02915835|"~     The primary objective of this study is to provide preliminary data on the efficacy (digital~     ulcer net burden) and safety of riociguat administered 3 times daily (TID) in comparison to~     placebo in patients with scleroderma-associated digital ulcers~   "
49740|NCT02915822|"~     The aim of this study is to assess the feasibility of conducting a study to compare the~     patient recorded and clinical outcomes for the surgical management of Hallux Valgus~     correction. A prospective trial will randomise the patients into two groups - Open Scarf/Akin~     osteotomy and Minimally Invasive Chevron/Akin osteotomy.~   "
49741|NCT02915809|"~     The purpose of this study is to evaluate immunological efficacy and safety of GC3110B versus~     GCFLU Quadrivalent Inj. among healthy adults in 18 to 60 years of age.~   "
49742|NCT02915796|"~     The main aim of the present study was to evaluate the therapeutic potential and safety of~     transarterial infusion of granulocyte colony stimulating factor (G-CSF) mobilized cluster of~     differentiation (CD) 133(+) cells when combined with percutaneous transluminal angioplasty~     (PTA) in treatment of below the knee (BTK) peripheral arterial disease (PAD) in diabetic~     patients.~   "
49745|NCT02915757|"~     Suicide, suicide attempts and depression are major social problems. The present research~     program focuses on the relationship between electrodermal hyporeactivity, as measured by the~     ElectroDermal Orienting Reactivity (EDOR) Test, and suicide and suicide attempts with death~     intent in patients with a primary diagnosis of depression. Electrodermal hyporeactivity has~     in several publications from different laboratories repeatedly been shown to have a high~     sensitivity (up to 97%) and high raw specificity (up to 98%) for suicide. Such levels are~     unique in psychiatry. The relationship between suicidal propensity and hyporeactivity can be~     considered as strongly significant. Almost all evidence in the topic up today has been~     established in research settings with specific exclusion criteria for some secondary~     psychiatric and some somatic illnesses. However, it is important to study the relationship~     between electrodermal hyporeactivity and suicide in relatively unselected patients regarding~     secondary psychiatric diagnoses and somatic diagnoses in a natural clinical ward situation~     and milieu. A previous naturalistic study proved that a test of electrodermal hyporeactivity~     fits very well into the daily clinical work.~   "
49746|NCT02915744|"~     This is an open-label, randomized, active comparator, multicenter, international Phase 3~     study of NKTR-102 versus TPC in patients with metastatic breast cancer who have stable brain~     metastases and have been previously treated with an anthracycline, a taxane, and capecitabine~     in either the adjuvant or metastatic setting (prior anthracycline may be omitted if medically~     appropriate or contraindicated for the patient).~   "
49747|NCT02915731|"~     This study will assess total body vitamin A pool size, as well as liver vitamin A stores, by~     means of stable isotope dilution in preschool children from a South African community where~     liver, an exceptionally rich source of vitamin A, is frequently eaten, and the children~     exposed to vitamin A fortified staple foods, as well as a vitamin A supplementation~     programme.~   "
49748|NCT02915718|"~     Dilated cardiomyopathy (DCM) causes significant morbidity and mortality and is the third most~     common cause of heart failure and the most frequent reason for heart transplantation. The~     etiology of dilated cardiomyopathy(DCM) is complex. There is a growing body of literature~     suggesting that the humoral immune system activation and autoantibodies against myocardial~     generation play an important role in the progression of DCM. At present immunoadsorption~     technology has been successfully applied in autoimmune antibody removal treatment of a~     variety of diseases. And some applications of immunoadsorption(IA) in patients with DCM~     showed that immunoadsorption(IA) can indeed reduce the autoantibodies, improve symptoms and~     prognosis, but additional research is needed to identify indications and instruments for the~     IA treatment of DCM.~   "
49749|NCT02915705|"~     UX023-CL301 is a multicenter, randomized, open-label, Phase 3 study comparing the efficacy~     and safety of KRN23 with active control (oral phosphate/active vitamin D therapy) in children~     with XLH (aged 1 to ≤12 years) who have radiographic evidence of rickets, open epiphyses, and~     have received oral phosphate/active vitamin D therapy for ≥ 6-12 consecutive months prior to~     screening. Approximately 60 subjects will be randomized 1:1 to receive open-label KRN23~     administered by subcutaneous injection or oral phosphate and active vitamin D therapy for a~     total of 64 weeks.~   "
49750|NCT02915692|"~     The Foley catheter is one component in a catheter insertion procedure that could contribute~     to a catheter associated urinary tract infection (CAUTI). Improvements in the catheter~     insertion procedure using the ERASE CAUTI Tray system may help to lower these infection~     rates.~   "
49751|NCT02915679|"~     In France, almost 1 death on 50 is a suicide. The suicide occurs in unbearable psychic pain~     where mental trouble has a major influence. It is classified as preventable mortality.~     According to interpersonal psychological theory of suicide, the repeated exposition to~     stressful and painful events (as physical abuse) would facilitate suicide attempt through the~     increased pain tolerance. The social pain (or psychical pain on the broader sense) and~     physical pain are closely linked.~      The investigators hypothesize that the measure of painful perception will be significantly~     superior on suicidals attempters compared to non-attempters. It will be the case for recent~     suicide attempters and former suicide attempters, suggesting a suicidal vulnerability trait.~     Moreover, the investigators expect that social distress induced by a social exclusion~     paradigm will be significantly superior on suicide attempters compared to non-attempters.~      The aim of the study is to investigate the physical and psychic pain on depressed subjects~     with or without history of suicide attempts.~      After a clinical evaluation (psychiatric symptomatology, personality trait, suicidal~     dimension), subjects will be submitted to a painful thermic stimulation and will participate~     at a computer test of social exclusion (named Cyberball).~   "
49752|NCT02915666|"~     This study is being done to find out if the combination of dabrafenib, trametinib and digoxin~     will lessen the side effects that you may experience and to measure your response and~     duration of response to the combination of drugs.~   "
49753|NCT02915653|"~     The study is a pre-post two round, randomized controlled study design of PCPs randomly~     assigned to a control or 1 of 2 intervention arms.~   "
49754|NCT02915640|"~     This study compares the utilization of remote technology versus not using remote technology~     when triaging and managing pediatric patients in remote settings prior to pediatric~     specialized inter-facility transportation.~   "
49755|NCT02915627|"~     Study comparing different groups of people and how they respond to application of the~     non-pneumatic anti-shock garments. Investigators will divide all recruited participants into~     three groups based on health status (group 1: hemodialysis patients; group 2: patients with~     severe chronic kidney disease but not on dialysis; group 3: healthy participants with no~     clinically known kidney disease). Each group, which will comprise of 10 people, will receive~     the same treatment using the non-pneumatic anti-shock garments.~   "
49778|NCT02915328|"~     Stenting is an alternative to traditional surgery in the treatment of carotid stenosis.The~     intra and/or postprocedural cerebral embolization remains the most frequent complication.~      The type of carotid stent and of cerebral protection are the two most important variables~     potentially affecting the rate of cerebral microembolization. So far there no consensus on~     the the best stent and cerebral protection.~   "
49823|NCT02914743|"~     The purpose of this research intervention is to assess the oral health status and periodontal~     health of patients with diabetes hospitalized on a general medicine service, and to assess~     the effect of providing dental prophylaxis and motivational interviewing to patient~     health-seeking behaviors and provider attitudes towards oral health, as well as on patient~     health outcomes.~   "
49756|NCT02915614|"~     In a former study, the investigator observed significant differences in the response to~     pulmonary rehabilitation between COPD patients with the normal genetic variant of alpha-1~     antitrypsin (PiMM) and those with a homozygous deficient variant (PiZZ) (Jarosch et al.,~     2016, DOI: 10.1159/000449509). PiZZ COPD patients showed less improvement in exercise~     capacity compared to PiMM patients. This latter finding was mirrored by an increase of~     oxidative myofiber type I proportion - that is important for aerobic exercises in daily life~     - in PiMM but not PiZZ patients.~      Based on this finding of impaired skeletal muscle adaptation, the aim of this study is to~     compare the effects of pulmonary rehabilitation including exercise training on a) specific~     enzymes of energy metabolism reflecting the oxidative capacity of the skeletal muscle and b)~     the analogue gene expression of these oxidative enzymes in a cohort of PiMM and PiZZ COPD~     patients.~   "
49757|NCT02915601|"~     Low serum bicarbonate levels, even within the normal laboratory range, are strongly~     associated with increased risks of hypertension, endothelial dysfunction, cardiovascular~     disease and death. The current proposal will investigate whether bicarbonate administration~     in patients with chronic kidney disease (CKD) will improve the health and function of~     arteries and reduce the size of the left ventricle of the heart. Overall, the proposed~     research will provide important new scientific evidence upon which physicians can base~     recommendations to patients with CKD to decrease the risk of developing cardiovascular~     diseases.~   "
49758|NCT02915588|"~     The purpose of the study is to compare two different rehabilitation protocols after~     arthroscopic rotator cuff surgery.~   "
49759|NCT02915575|"~     The purpose of this trial is to test the clinical benefit and feasibility of structured risk~     based post discharge care for hospital acquired Acute kidney injury survivors.This is a~     Pragmatic randomized controlled trial. It will be conducted at 2 hospitals in Alberta. 166~     participants will be enrolled in this Randomized controlled trial..~   "
49760|NCT02915562|"~     The purpose of this study is to determine the effects of depressive mood on outcomes of an~     in-house rehabilitation program.~   "
49761|NCT02915549|"~     To test the hypothesis that progressive feeding without minimal enteral feeding (MEF)~     compared to progressive feeding preceded by a 4-day course of MEF will result in an increased~     number of days alive on full enteral feeding in the first 28 days after birth in extremely~     preterm infants receiving human milk.~   "
49762|NCT02915536|"~     With the implementation of Universal Salt Iodization (USI) in 1995, China has successfully~     combated Iodine Deficiency Diseases (IDD). However, China is a country with a complicated~     iodine geographical environment with wide natural variation in the iodine content of drinking~     water. It has been reported that the water iodine of at least 11 provinces and cities in~     China is high, with nearly 31 million people exposed to the risks of excessive iodine intake.~     This has raised a new public health concern that a safe upper level of iodine intake should~     be established to ensure that people avoid ingesting excessive iodine intake while continuing~     to implement USI to control IDD. The investigators have successfully explored the tolerable~     upper intake level (UL) of iodine for Chinese adults by conducting a randomized~     double-blinded trial in 256 euthyroid volunteers. However, due to limited data on the safe~     upper intake level of iodine for children worldwide, current ULs of iodine for children are~     extrapolated from those for adults based on body weight or body surface area. As it is~     impossible to ethically conduct a randomized clinical trial regarding excessive iodine intake~     in children, the investigators plan an observational study to investigate children who have~     been living with different drinking water iodine levels for over 5 years, observing the~     changes of thyroid function in response to each iodine exposure level. Subtle changes in~     thyroid function and thyroid volume of children corresponding to different iodine intake~     levels will be determined, which will contribute to the establishment of UL of iodine for~     children.~      The aim was:~        1. To establish the tolerable upper intake level (UL) of iodine for children of China.~        2. To define the adverse effects of excess iodine on children.~        3. To monitor the iodine status of children living in high water iodine areas in China.~   "
49763|NCT02915523|"~     The purpose of this study is to determine the biologically active dose of entinostat, when~     given in combination with avelumab, that is safe and warrants further investigation.~     Additionally, this study will evaluate the effectiveness of entinostat in combination with~     avelumab at the determined dose in terms of progression free survival compared to avelumab~     plus placebo in patients with refractory or recurrent epithelial ovarian cancer.~   "
49764|NCT02915510|"~     This study will evaluate the safety, gastrointestinal (GI) tolerance, acceptability and~     compliance of a Glycomacropeptide-based protein substitute for patients with Phenylketonuria~     (PKU).~   "
49765|NCT02915497|"~     The objective of this study is to assess the feasibility and effectiveness of AEPET plus~     Resilience Based Therapy (RBT) versus RBT alone for the prevention of PTSD and depression in~     trauma patients. The intervention group who have AEPET plus RBT will have reduced level of~     post traumatic stress symptoms and depression post sessions as well as reduced symptoms of~     PTSD and depression at 4- 6 weeks as compared to the control group who have -Resilience~     Based less specific supportive therapy.~   "
49766|NCT02915484|"~     The purpose of this study is to test the efficacy and safety of tDCS (Transcranial Direct~     Current Stimulation) on apathy in stroke patients.~   "
49767|NCT02915471|"~     The overall aim of this research program is to develop and examine the impact of a Cancer~     virtual peer-to-peer (VP2P) Support Program on health-related quality of life (HRQL) in~     adolescents with cancer (AWC). In the current proposal, the feasibility of trialing the~     Skype-based VP2P program providing peer-support from mentors and the magnitude of program~     effect estimates will be evaluated in a pilot randomized control trial (RCT). This pilot RCT~     will enable us to refine the program and determine the appropriate sample size for a future~     large-scale RCT, which will compare the effectiveness of VP2P to a waitlist control group at~     a major Children's Oncology Group- affiliated centers in Canada and the United States.~   "
49768|NCT02915458|"~     Making a weaning decision for a patient on a mechanical ventilator is an important clinical~     issue. The most common index to predict successful weaning is the rapid shallow breathing~     index (RSBI), however, the accuracy of RSBI to predict successful weaning have been~     questioned.~      The investigators proposed a new mathematical model and algorithm, called WIN, which capture~     the essential feature of the variability ruling the physiological dynamics to provides better~     perdition to wean than RSBI.~   "
49799|NCT02915055|"~     This will be a single-center, prospective observational study. The study will compare~     post-operative pain scores and narcotic consumption between two groups of patients - one~     cohort will receive ibuprofen (Motrin) and Percocet (to be used as needed) while the other~     cohort will receive only Percocet. Both pain management options are considered to be standard~     of care.~      The primary objective of the study is to compare patients' reported pain and narcotic use~     following meniscectomy, and determine if NSAIDs can provide adequate pain relief.~   "
49769|NCT02915445|"~     This study is for patients that have nasopharyngeal carcinoma or breast cancer. As epithelial~     cell adhesion molecule (EpCAM) is a well characterized molecule that is closely with poor~     prognosis and tumor metastasis and invasion. Many therapies targeting EpCAM have shown~     benefits for cancer patients. This study is to determine the safety of the engineered T cells~     armed with chimeric antigen receptor (CAR-T) recognizing EpCAM. At the same time, efficacy is~     to be evaluated by the criteria of RECIST. The EpCAM CAR-T were produced by lentiviral~     transduction of the 3rd generation of CAR genes. Different cohorts of patients receive EpCAM~     CAR-T with a dose-escalating manner. This study is to find the largest dose of EpCAM CAR-T,~     to learn what the adverse effects are and to find out whether this experimental intervention~     might help patients with nasopharyngeal carcinoma or breast cancer.~   "
49770|NCT02915432|"~     The purpose of this study is to preliminarily evaluate anti-tumor activity of a Recombinant~     Humanized Anti-PD-1 Monoclonal Antibody for Infusion (JS001) in treating advanced gastric~     adenocarcinoma, esophageal squamous cell carcinoma, nasopharyngeal carcinoma and head and~     neck squamous cell carcinoma and to determine the recommended phase II dose (RP2D)~   "
49771|NCT02915419|"~     This study aims to compare the ability of different regenerative protocols in the treatment~     of mature necrotic~   "
49772|NCT02915406|"~     This protocol is designed to enable access to related or unrelated CD34 cells manufactured~     using the CliniMACS (Miltenyi) under the HUD designation for patients needing T cell depleted~     allogeneic grafts for hematopoietic stem cell transplant (HSCT). This will include patients~     with inherited immunodeficiency disorders as well as patients with malignancies, bone marrow~     failure, and other rare diseases amenable to HSCT. Finally, patients with poor graft function~     and Graft Versus Host Disease(GVHD) after a previous HSCT may require a boost of T-cell~     depleted donor Peripheral Blood Stem Cell (PBSCs) or bone marrow cells that are CD34 selected~     using the CliniMACS device ENROLLMENT BY INVITATION ONLY~   "
49773|NCT02915393|"~     Spleen Deficiency Syndrome(SDS)is a widely researched issue, but due to the limitations of~     the research methods, the scientific mechanism of SDS is biased and not comprehensive. SDS~     would be researched in this project deeply and systematically with modern life-scientific~     methods. Based on the previous work, the participants, with SDS, suffering from Qi deficiency~     syndrome--chronic superficial gastritis--chronic atrophic gastritis--gastric cancer would be~     included, and the corresponding research would be conducted at the molecular-cell-gastric~     tissue level, and at the same time, systematical biological database of SDS would be built by~     systematical biological methods, such as pioneered SPARS sequencing technology created in our~     research group, proteomics and metabonomics. Under the above work, the investigators would~     conduct data mining and molecular network analysis, and then verify the key functions. By~     analyzing the systematical biological features of syndrome and its relationships with~     constitution and disease, this study would provide a new basis for objective reality of~     syndrome, and also offer a crucial premise of revealing biological basis for syndrome~     correctly, which is of important theoretical and practical significance.~   "
49774|NCT02915380|"~     Recently, the occurrence and potential impact of pituitary dysfunction after aSAH has gained~     increasing interest. Several studies have demonstrated pituitary dysfunction after SAH~     suggesting that pituitary dysfunction may be a contributing factor for residual symptoms~     after SAH. This is an observational multicentric study aimed to test the prevalence of~     thyroid abnormalities, other neuroendocrinological dysfunction and their influence on outcome~     of patients affected by aSAH.~   "
49775|NCT02915367|"~     Next generation real-time monitoring for PrEP adherence in young Kenyan women~   "
49776|NCT02915354|"~     The inclusion criteria was patients who aged 18 or older with ankylosing spondylitis,~     fulfilled the 1984 modified New York criteria for AS. Inclusion criteria enriched the AS~     patients with clinical remission, including the following definition: 1. Administration of~     etanercept 50 mg for 6-week period at least; 2. Acquisition of Assessment of~     SpondyloArthritis International Society criteria 20(ASAS20) response at the end of the~     treatment. We excluded patients who have developed to complete spinal fusion. We also~     excluded patients with kidney disease induced by other conditions; pregnancy; suckle;~     accompany other chronic diseases; various infections in acute stage; and other infectious~     diseases. At the end of the trial, patients who fulfilled the inclusions would stop~     etanercept treatment. Cotherapy with disease modifying anti-rheumatic drugs or non-steroidal~     anti-inflammatory drugs could be continued if maintained at a stable dose;Patients were~     followed up from the time of etanercept withdrawal per 6 weeks for 3 years by telephone. If~     symptoms suggestive of relapse or other problems occurred, patients were invited to come back~     to the center. Relapse after etanercept withdrawal was defined as an increase Bath~     Spondylitis Disease Activity Index(BASDAI)15 score goes back to 80 percentages of it at the~     beginning of the trial16. The following data were collected: demographic and disease~     characteristics, therapeutic modification, clinical values (BASFI, Bath Ankylosing~     Spondylitis Global Score (BAS-G)), Ankylosing Spondylitis Disease Activity Score (ASDAS)1718)~     and biologic values at baseline of the trial and the time of relapse. Adverse events and~     other safety measures were also collected.~   "
49777|NCT02915341|"~     The overall objective of this study is to extend previous work in the development of methods~     to automatically detect the timing of cocaine use from cardiac interbeat interval and~     physical activity data derived from wearable, unobtrusive mobile sensor technologies. The~     specific objectives of this protocol are to characterize under which conditions high quality~     continuous interbeat interval data and physical activity data can be obtained from a~     specially developed smartwatch device in the natural field setting among a population of~     cocaine users. In addition to identifying common failure scenarios and understanding~     wearability/usage patterns when collecting interbeat interval from smartwatches, this study~     will extend previous work in the detection of cocaine use via interbeat interval and physical~     activity data that were previously obtained from wearable chestband sensors. Information from~     this study will contribute toward the adaptation of the investigators' existing computational~     model for detecting cocaine use via the chest sensors, so it can be applied to the interbeat~     and physical activity data obtained from less obtrusive smartwatches.~   "
49800|NCT02915042|"~     The primary objective of this study is to evaluate the efficacy of administering intravenous~     dexmedetomidine as a single preemptive dose to placebo in reducing the total 24 hour dose of~     opioids as measured on a weight adjusted morphine equivalent basis.~   "
49779|NCT02915315|"~     Essential hypertension is a complex trait which results from interaction between~     environmental factors and genetic factors. Our study aimed to detect the differential~     expression of LncRNAs and epigenetic changes such as DNA methylation associated with salt~     sensitive hypertension in human based on a chronic salt loading study conducted in Lantian~     county, China. Firstly, a chronic salt loading study will be conducted in a Chinese~     population to differentiate salt-sensitive and salt-resistant individuals. Second, LncRNAs~     and DNA methylation Chip analysis will be performed using samples collected from~     salt-sensitive and salt resistant individual, and the results will be analyzed by modern~     bioinformatics methods to seek for differential genetic markers. In addition, the~     investigators also try to examine the effects of chronic salt loading on BP, ambulatory BP,~     microalbuminuria and baPWV and other biochemical indexes. This project had great significance~     to reveal molecular genetics mechanism in the development of salt, salt-sensitive and~     hypertension.~   "
49780|NCT02915302|"~     The aim of the study was to describe the safety and immunogenicity of a 0.5-mL dose (15 μg~     hemagglutinin [HA] per strain) of Fluzone Quadrivalent vaccine in children 6 to <36 months of~     age.~      Primary objective:~        -  To compare the rate of any fever (temperature ≥100.4 degrees Fahrenheit [38.0 degrees~          Celsius) following a 0.5-mL dose of Fluzone Quadrivalent vaccine to that following a~          0.25-mL dose of Fluzone Quadrivalent vaccine during the 7 days after either vaccination~          (Dose 1 and Dose 2 combined) in participants 6 to < 36 months of age.~      Secondary objective:~        -  To compare antibody responses induced by a 0.5-mL dose of Fluzone Quadrivalent vaccine~          to those induced by a 0.25-mL dose of Fluzone Quadrivalent vaccine as assessed by~          geometric mean titer (GMT) ratios and seroconversion rate differences after the final~          vaccination in participants 6 to < 36 months of age.~      Other objectives:~        -  To describe the safety of 2 different dose levels of the 2016-2017 formulation of~          Fluzone Quadrivalent vaccine in participants 6 to < 36 months of age.~        -  To describe the immunogenicity of 2 different dose levels of the 2016-2017 formulation~          of Fluzone Quadrivalent vaccine in participants 6 months to < 36 months of age.~        -  To submit available sera from approximately 30 participants to the Center for Biologics~          Evaluation and Research for further analysis by the World Health Organization, the~          Centers for Disease Control and Prevention, and the FDA to support formulation~          recommendations for subsequent influenza vaccines.~   "
49781|NCT02915289|"~     Endometritis, an infection of the uterus in the postpartum period, has been shown to~     complicate the postoperative course of a cesarean delivery in 6% to 27% of cases. Vaginal~     cleansing prior to cesarean delivery has been shown to minimize the presence of~     micro-organisms and risk of infection. Although povidone-iodine is the most commonly used~     anti-septic for surgical preparation of the vagina, it is not an ideal agent due to it's~     diminished efficacy in acidic vaginal pH and in the presence of blood. Chlorhexidine~     gluconate, on the other hand, has demonstrated superior disinfectant properties in several~     clinical trials, as compared to povidone iodine. In this randomized, comparator controlled,~     study the investigators will be comparing chlorhexidine gluconate vs povidone iodine for~     intrapartum vaginal preparation in women undergoing non-emergent cesarean delivery.~   "
49782|NCT02915276|"~     For the purpose of this study, the investigators will perform the removal of trophectoderm~     (TE) the cells as required for the purpose of pre-implantation genetic screening, in order to~     perform the genetic analysis. Additionally, the investigators will remove the blastocoelic~     fluid (BF) and perform additional genetic analysis on the embryo in order to determine the~     agreement of the genetics results between TE cells and BF.~   "
49783|NCT02915263|"~     The goal of this pilot study is to obtain preliminary data on the magnitude of the treatment~     effect of IVIG on the neuropathic pain and neuropathy severity associated with treatment~     induced neuropathy (TIND).~      The investigators hypothesize that immune globulin, administered intravenously (IVIG), will~     reduce the pain associated with treatment induced neuropathy and reduce the neuropathy~     severity.~      Treatment induced neuropathy in diabetes, is an iatrogenic complications of diabetes. The~     preliminary data will be used to power a larger treatment trial, and to aid the understanding~     of the mitigating factors in the treatment response.~   "
49784|NCT02915250|"~     This is a two-centre, randomised, double-blind, double-dummy, 3-treatment, 3-period~     cross-over study using a standardised solid meal test in subjects with type 2 diabetes to~     investigate postprandial glucose control of BioChaperone® Combo compared with Humalog® Mix25~     and with simultaneous subcutaneous injections of Humalog® and Lantus® during three separate~     dosing visits.~   "
49785|NCT02915237|"~     Gulf War Illness (GWI) is a multi-symptom disorder that is characterized by complex traits~     such as fatigue, headaches, joint pain, insomnia, and memory problems. With no treatment for~     GWI currently available, there is an urgent need to develop novel interventions to alleviate~     major GWI clinical complications. Recent evidence highlights the potential value of~     flavonoids, a subclass of organic chemical called polyphenols abundantly found in some plants~     and common dietary preparations, in helping relieve clinical complications in Veterans with~     GWI. The overall goal is to test whether daily consumption of commercially available Concord~     grape juice, which is very Flavonoid-rich, is effective for treating cognitive deficits and~     chronic fatigue in Veterans with GWI.~   "
49786|NCT02915224|"~     This multicenter, single arm, non-interventional, observational study will evaluate the~     efficacy and safety of obinutuzumab in daily clinical practice in participants with chronic~     lymphocytic leukemia (CLL). The study will also assess cost of disease management. The total~     length of the study is 42 months.~   "
49787|NCT02915211|"~     To evaluate the tolerance, acceptability and compliance of Keyo in 20 subjects aged 3 years~     and over, with intractable epilepsy or Glut-1 DS on a KD.~   "
49788|NCT02915198|"~     This research will help us to learn if the medicine called metformin reduces the risk of~     death, heart attacks, and/or strokes in patients who have pre-diabetes and heart or blood~     vessel problems.~   "
49822|NCT02914756|"~     Is HMGB1 (High Mobility Group Box 1) elevated in sepsis patients for weeks after recovery~     from severe sepsis/septic shock, similar to what has been observed in mice? Do patients~     recovering from severe sepsis/septic shock suffer from cognitive impairment and is such~     impairment associated with prolonged HMGB1 levels in plasma? Is there a difference from~     patients recovering from critical illness without prior sepsis?~   "
49789|NCT02915185|"~     A substantial proportion of individuals are left with poor residual functioning of the~     affected arm after a stroke. This has a tremendous impact on the quality of life and the~     ability for stroke survivors to live independently. While exercise is considered essential to~     any rehabilitation program, its benefits are generally far from optimal because of the lack~     of proper dosing in terms of intensity. One way to tackle this problem is to develop better~     tools that could predict an individual's potential and then adjust the intensity of exercise~     accordingly. One such predicting tool exists and consists of using non-invasive brain~     stimulation such as transcranial magnetic stimulation (TMS), to assess the integrity of~     descending motor pathways originating from the brain. TMS consists of applying a magnetic~     wand near the scalp to stimulate brain cells without inducing pain or discomfort. One goal of~     the current proposal is to use TMS to test the integrity of the motor pathway in chronic~     stroke survivors. The level of responses to TMS will be used to classify participants in~     terms of potential for recovery and then, to determine the optimal level of exercise. The~     study will also examine the effect of another non-invasive brain stimulation technique called~     transcranial Direct-Current Stimulation—tDCS to determine whether it can enhance the response~     to strength training exercise in the affected arm. Half of the participants will be trained~     with the tDCS on, while the other half will be trained with the stimulator off. The training~     program will last 4 weeks; 3X/week. Both clinical and neurophysiological measures will be~     performed to determine the impact of the strength training intervention on participants.~     Overall, the proposed project is expected to have a positive and significant impact on stroke~     survivors' quality of life.~   "
49790|NCT02915172|"~     There are 2 phases in this study: Phase 1 (dose escalation) and Phase 2 (dose expansion).~      The goal of Phase 1 of this clinical research study is to find the highest tolerable dose of~     lenvatinib and Xeloda (capecitabine) that can be given to patients with advanced cancer. The~     goal of Phase 2 of this study is to learn if the dose of lenvatinib and capecitabine found in~     Phase 1 can help to control advanced cancer.~      The safety of this drug combination will be studied in both phases of the study.~   "
49791|NCT02915159|"~     The purpose of this study is to evaluate the efficacy of abatacept compared to placebo in~     patients with Sjögren's Syndrome.~   "
49792|NCT02915146|"~     Narrowband ultraviolet B phototherapy is the standard phototherapy for atopic eczema;~     ultraviolet A1 is sometimes used but is not a widely available treatment. We do not know the~     most important chromophores in treating atopic eczema; in which phototherapy is thought to~     work by improving epidermal barrier function, having beneficial effects on skin microbiome~     and local immunosuppression. It seems plausible that there are several chromophores and that~     'targetting' several at once with different wavebands should help and for severe eczema that~     has not responded adequately to narrowband UVB or ultraviolet A1 alone the combination is~     sometimes used. This study is to test if the combination is moderately to greatly more~     effective than narrowband ultraviolet B monotherapy amongst patients referred for any form of~     first-line phototherapy for atopic eczema.~   "
49793|NCT02915133|"~     Macular foveoschisis (MF) is a common complication of pathological myopia, which is~     characterized by choroid-retinal degeneration and vision impairment. Although pars plana~     vitrectomy (PPV) is the primary method for MF treatment, there is still a large proportion of~     recurrent MF due to the extremely long global axial length and posterior staphyloma. Macular~     buckling (MB) surgery aims at counteracting the traction exerted by the posterior staphyloma,~     and has been proven an effective method for treating MF. Optical Coherence Tomography (OCT)~     is widely used for the structural analysis of MF. Multifocol electroretinogram (mfERG) is an~     objective examination for visual evaluation. To our knowledge, there is a lack of data on the~     comprehensive visual function evaluations of MF patients associated with OCT findings. Our~     clinical trial aims to provide the structural and functional relationship in MF patients~     undergoing MB surgery, and find out potential factors to determine the visual prognosis.~   "
49794|NCT02915120|"~     The purpose of this study is to determine if patients with chronic painful knee~     osteoarthritis experience meaningful and long-term improvement in pain, function, and~     analgesic use after ultrasound-guided pulsed radiofrequency of the genicular nerves following~     a double diagnostic genicular nerve blocks.~   "
49795|NCT02915107|"~     The aim of the Danish Organization for Randomized Trials with Clinical Outcome (SORT OUT) IX~     STEMI OCT is to compare early vascular healing of the polymer-free Biolimus-eluting~     BIOFREEDOM stent with a biodegradable-polymer Sirolimus-eluting ORSIRO stent in patients with~     ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary~     intervention (PCI).~   "
49796|NCT02915094|"~     Objective of the study is to gain knowledge about the administration of Kineret in patients~     with rheumatoid arthritis in the daily routine treatment and not in controlled trials. In the~     current survey, the investigation of the response rate of Kineret regarding the date of onset~     of action, the efficacy, as well as the tolerability and safety are of particular interest.~   "
49797|NCT02915081|"~     The investigators hypothesize that subjects undergoing liver resection and who are exposed~     preoperatively to high illuminance blue spectrum light will exhibit reduced organ injury,~     specifically liver dysfunction, than subjects exposed to standard ambient white fluorescent~     light.~   "
49798|NCT02915068|"~     The investigators propose to modify and expand the internationally-recognized evidence-based~     Physician Asthma Care Education (PACE) program to make it a suitable tool for training~     primary care clinicians on the effective use of EHRs at the point of care. The investigators~     will first develop the EHR edition of PACE (EHR-PACE) through literature and expert review of~     best practices for clinicians interacting with patients in the presence of computer systems~     in the exam room. They will then establish the feasibility and potential impact of EHR-PACE~     via a randomized design on 125 patients of 20 physicians who receive the intervention on the~     following outcomes via survey 3 and 6 months post-intervention: patient satisfaction with the~     physician's performance, asthma control, and asthma-related quality of life. Outcomes will be~     assessed on patients, but physicians will receive the intervention. Patients will not know~     which arm their doctor was randomized to. The pilot trial will compare two groups of primary~     care physicians who see patients with asthma in clinics equipped with certified EHRs. It is~     hypothesized that patients of physicians who receive EHR-PACE training will achieve better~     outcomes compared to physicians who do not receive EHR-PACE.~   "
49801|NCT02915029|"~     People reach End Stage Renal Disease (ESRD) due to progressive chronic kidney disease (CKD).~     CKD is associated with increased risks for heart disease and death. The burden of chronic~     kidney disease is increased among minority populations compare to Caucasians. The Zuni~     Indians are experiencing an epidemic of chronic kidney disease is due primarily to the high~     rates of obesity and diabetes. The present study entitled Home-Based Kidney Care is designed~     to delay / reduce rate of ESRD by early interventions in CKD. Investigators propose to assess~     the safety and efficacy of conducting a full-scale study to determine if home based care~     delivered by a collaborative team composed of community health workers and University of New~     Mexico faculty will decrease the risk for the development and the progression of CKD.~   "
49802|NCT02915016|"~     This study will evaluate the safety and immune response to the DNA-HIV-PT123 vaccine used in~     combination with one of two protein vaccines (Bivalent Subtype C gp120/MF59 or Bivalent~     Subtype C gp120/AS01B) in healthy, HIV-uninfected adults.~   "
49803|NCT02915003|"~     With the help of local focus groups, the investigators are designing and testing a website to~     help urban people have better access to health care through understanding their insurance~     options better. They hypothesize that once individuals engage with the website and go through~     all of its modules, they will: 1) become more informed consumers of the ACA and its health~     insurance options; 2) enroll in an insurance plan; and 3) better leverage the benefits of~     their existing plans.~   "
49804|NCT02914990|"~     The main objective of this study is to evaluate the safety and tolerability of BPI-15086.~   "
49805|NCT02914977|"~     In this pilot study, eligible patients will be treated with 5 days of low dose daunorubicin~     for one cycle only. Any patient who receives treatment on this protocol will be evaluable for~     toxicity. Each patient will be assessed for the development of toxicity at all scheduled~     visits (Days 1-5). Following participation on this brief pharmacodynamic trial, patients can~     then proceed to other conventional or investigational therapies, as clinically indicated.~   "
49806|NCT02914964|"~     The purpose of this study is to compare the effect of the Swank Diet (low saturated fat) and~     the Wahls Elimination Diet (modified paleo) on fatigue levels in individuals with~     relapsing-remitting multiple sclerosis who have documented fatigue. Participants will follow~     their usual diet for 12 weeks and then be randomly assigned to follow one of the two diets~     for 24 weeks.~   "
49807|NCT02914951|"~     In addition to the core symptoms, children and adolescents with Autism Spectrum Disorder~     (ASD) often exhibit disruptive behavior problems including irritability, tantrums,~     noncompliance, and aggression. The purpose of this study is to investigate~     cognitive-behavioral therapy (CBT) for disruptive behavior in children with autism spectrum~     disorders and intellectual disability. This pilot study will include children with ASD and IQ~     between 55 and 85 in an open study of CBT. CBT is modified in this study to reduce complexity~     of activities during therapy sessions but retains all key elements and principles of CBT.~     Assessments of irritability and disruptive behavior will include clinical interviews, parent~     ratings and child self-report measures. Study participants will be asked to complete~     functional magnetic resonance imaging (fMRI) to evaluate biomarkers of social perception and~     emotion regulation before and after CBT.~   "
49808|NCT02914938|"~     This is a two-arm, Phase 1b, open-label, dose escalation study of ME-401 alone and an~     open-label study of ME-401 in combination with rituximab in patients with relapsed/refractory~     B-cell malignancies.~   "
49809|NCT02914925|"~     The purpose of this study is to assess the use of a commercially available arm weight~     supporting training system (Armeo®Spring) in conjunction with Constraint Induced Therapy~     (CIT) for improving upper extremity function for children with unilateral cerebral palsy. In~     addition, the study aims to assess the potential cortical changes with Armeo®Spring therapy~     and CIT with the use of the Transcranial Magnetic Stimulation (TMS) motor mapping.~      This within-subjects repeated-measures study will be conducted at St. Mary's Hospital for~     Children. Subjects will be recruited from the general population. A sample size of 10~     participants is required for the study. Minority and gender distributions of this study are~     expected to reflect the distributions in the general population of this region.~      Therapy: Participating children will have their unaffected arm placed in a sling. The sling~     is placed at the start of the day and the child is encouraged to have this on during all~     therapy sessions.The affected arm will be used for repetitive therapeutic activities.Therapy~     sessions will include activities aimed at building motor learning skills.~      TMS will be used to map the brain. Participants will have MRI of the brain that is T1~     weighted with 0.9 -1.1 voxel. size to allow for on-screen navigation of the cerebral cortex~     while performing TMS.The stimulating coil will be held to the scalp over each M1 hemisphere~     and an induced electrical current passed through the coil will create a magnetic pulse that~     stimulates the brain~      Children will be assessed using functional hand tests and TMS.~   "
49810|NCT02914912|"~     Patients suspected for chronic mesenteric ischemia shall be investigated with gastroscopy~     assisted laser Doppler flowmeter and light spectroscopy (GALS).~   "
49811|NCT02914899|"~     The purpose of this study is to improve the efforts of Community health workers (CHWs) by~     developing materials to help increase lung cancer screening in NYC Chinese taxi drivers who~     smoke or who have quit smoking within the past 15 years.~   "
49812|NCT02914886|"~     The purpose of this study is to investigate whether a zinc-free insulin is an effective~     treatment option for lipoatrophy in patients with type 1 Diabetes (T1D) and insulin pump~     (CSII, continuous subcutaneous insulin infusion) therapy.~   "
49813|NCT02914873|"~     A large proportion of men with prostate cancer are overdiagnosed and overtreated mainly due~     to PSA testing. Active surveillance (AS) aims to reduce these harms by recommending curative~     treatment only when and if signs of tumor progression occur. There are however a number of~     uncertainties in AS, the most important being when to initiate treatment. The investigators~     are therefore starting a large randomized multicenter trial testing the safety of a~     standardized active surveillance protocol with specified triggers for repeat biopsies and~     initiation of curative treatment. The standardized protocol is compared with current practice~     for active surveillance. The primary aim of the study is to reduce overtreatment and~     subsequent side effects, without increasing the risk of disease progression or prostate~     cancer mortality.~   "
49814|NCT02914860|"~     The purpose of this study is to compare DUA (discrete uptake accumulations) of mIBG activity~     in patients with different forms of atrial fibrillation and within a sub-group of healthy~     subjects.~   "
49815|NCT02914847|"~     Self-harm has substantial personal impacts as well as costs on the National Health Service~     (NHS). Around 13-17% of young people report experiences of self-harm. In Cambridgeshire, this~     is a significant issue with the number of admissions to hospital for self-harm in young~     people being higher than the United Kingdom (UK) average. Treating underlying mental illness~     can lead to a reduction in self-harm, but these are long interventions for complex disorders~     and many people who self-harm are not under treatment for mental illness. Moreover, young~     people struggle to access traditional mental health services where these therapies are~     delivered. No short interventions specifically tailored for young people have been developed~     so far.~      The Imaginator project aims to address the urgent need for an effective and innovative~     short-term therapy for self-harm in young people. The investigators will pilot a new~     imagery-based psychological intervention for young people aged 16-25 who experience~     repetitive self-harm. Mental imagery (the experience of seeing through the mind's eye) can~     carry intense emotions (positive and negative), and imagining something can facilitate~     behaviour. Imagery-based therapies have proven useful (i) for problems that feature intense,~     hard to manage emotions such as those associated with self-harm, and (ii) for promoting~     healthy behaviour. Our new intervention called Functional Imagery Training will support young~     people to imagine more adaptive behaviours to cope with the emotional distress that triggers~     self-harm, and motivate them to reduce self-harm. Imaginator will comprise of just two~     sessions followed by phone support over three months.~      Moreover, the investigators will address the challenge of young people accessing and staying~     in therapy by using a smartphone app to support the therapy, as apps are widely used and~     favoured by this age group. The app will enable participants to continue with the strategies~     they have learnt in therapy by themselves, thus ensuring a potential longer-term benefit and~     self-empowerment.~   "
49816|NCT02914834|"~     This pilot study aims to determine if it is possible to perform acupuncture on women~     diagnosed with stable angina who have symptoms. The investigators want to determine if~     acupuncture reduces the pain and other symptoms of angina. The investigators also want to~     examine whether this study is acceptable to the participants, and by carrying out this study~     the investigators will be able to tell how many participants they will need in a future~     larger study to further test acupuncture to reduce the symptoms of angina in women.~   "
49817|NCT02914821|"~     The study will take place at a cafe managed by university dining services and is located in a~     university building adjacent to the psychology building. The cafe sells sugar-sweetened~     beverages and a variety of diet drinks. The campus dining services and the manager of the~     cafe have given investigators permission to tax their sugar sweetened beverages and will~     provide their sales data for a 12 week period.~      The investigators will introduce four arms to the experiment. One arm will be baseline data~     where business 'as usual' will be conducted and no price increases will be implemented on~     SSBs. In the general tax condition the investigators will introduce a 3 cent/ounce tax on the~     five SSB flavors the café offers. In the Pre-K tax condition the investigators will institute~     a 3 cent/ounce tax but will label the tax as proceeds going to Pre-K education. This is~     designed after the Philadelphia tax that was recently passed where funds were earmarked to~     benefit childhood education. In the childhood healthy eating program condition the~     investigators will institute a 3 cent/ounce tax but will label the tax as proceeds going~     toward childhood healthy eating programs. In all tax conditions the firm will keep the~     proceeds, but the research team will make a donation to a Pre-K education non-profit and a~     childhood healthy eating non-profit of the amount generated by the tax during the study~     period.~      Each experimental arm will run for 3 weeks total (for a total study period of 12 weeks). The~     conditions will alternate by week (i.e., week 1: business as usual; week 2: general tax; week~     3: pre-K tax; week 4: childhood healthy eating tax; week 5: business as usual, etc). A~     research assistant will visit the café each week to make any necessary changes to signs that~     will label the drinks.~      The investigators will change the signage of the drinks in the cooler during the study~     period. For the baseline period there will be no changes to the signs made. Currently all~     beverages are labeled with their name and cost (e.g., Pepsi, $1.89). In the tax conditions~     the investigators will change the price of the drink (3 cents/ounce) and add a line notifying~     consumers of the soda 'surcharge' (note surcharge will be used in the study because no tax~     was actually passed by the local government). An example of this sign would be 'Pepsi, $2.29,~     includes 40 cent sugary drink surcharge.' In the Pre-K tax condition an added line will say,~     Pepsi, $2.29, includes a 40 cent sugar sweetened beverage surcharge. Proceeds benefit Pre-K~     education. In the childhood healthy eating programs condition the text will say, Pepsi,~     $2.29, includes a 40 cent sugary drink surcharge. Proceeds benefit Childhood Healthy Eating~     programs.~   "
49818|NCT02914808|"~     The chroedem study is aiming to assess tissue and biomolecular components of chronic lower~     limb oedema (CO). The investigators working hypothesis is that according to the aetiology of~     CO, the proportion of oedema & composition of peri-oedema tissues (fat, muscle,~     fibrosis/inflammation) might differ and could at least in part explain differences in~     failure/success of compressive therapies from one patient to another. For that purpose, 24~     patients with a post-thrombotic syndrome (PTS)-related oedema and 24 patients with a primary~     lymphedema will undergo a magnetic resonance imaging (MRI)) of the legs and biological~     (genetic) testing.~   "
49819|NCT02914795|"~     Approx. 65% of resuscitated patients at the intensive care unit for internal medicine are due~     to myocardial infarction. Almost all patients are initially diagnosed and treated in the cath~     lab. Therapy usually consists of one or more stent implantations. After implantation of a~     coronary stent, dual platelet inhibition is necessary for 12 months. Insufficient platelet~     inhibition causes an pronounced increase in risk of stent thrombosis. Therefore, knowledge of~     the individual platelet function is valuable.~      Several factors potentially promote a delayed or reduced mode of action of platelet function~     inhibitors in resuscitated patients:~        1. oral administration is impossible and medication needs to be administered via a gastric~          line.~        2. gastric absorption is delayed after resuscitation~        3. according to current guidelines patients are treated with therapeutic hypothermia.~          Including the time of rewarming cooling period is ~48h~   "
49820|NCT02914782|"~     Critically ill patients need intravenous fluid therapy in order to correct or prevent~     problems with their fluid and/or electrolyte status and for renal protection. The decision~     for the optimal composition and amount of IV-fluids can be difficult and complex. It is well~     known that errors in fluid- and electrolyte management contribute to overall morbidity and~     mortality. For decades, urinary sodium was used to diagnose renal disease. Nevertheless,~     renal excretion of sodium is largely impaired in critically ill patients, particularly in~     patients with acute kidney injury. Due to the high frequent measurement of renal output, it~     would be possible to measure the urinary electrolytes and its relative changes. Urinary~     electrolyte measurement may alert for the presence of the development of an akute kidney~     injury before occurring increases in creatinine or oliguria. The rationale of this~     investigation is therefore to collect data related to fluid- and electrolyte management from~     critically ill patients in order to find patterns of fluid- and electrolyte imbalances which~     may lead to disturbances and further, may allow an early detection of acute kidney injury.~   "
49821|NCT02914769|"~     The purpose of the present trial is to test the efficacy of Ayahuasca in treatment-resistant~     depression. Ayahuasca is a decoction of two plants, long used by Amazonian Amerindians.~     Traditionally, it is prepared by decoction of a bush (Psychotria viridis) with a liana~     (Banisteriopsis caapi). P. viridis is a rich source of N,N-dimethyltryptamine (DMT), a~     serotonergic agonist, and B. caapi contains potent monoamine oxidase-A inhibitors (MAOi-A),~     such as harmine, harmaline. The study is designed as a randomized placebo controlled trial~     with two parallel arms, and it will also evaluate changes of different biomarkers of~     depression including anatomical and functional Magnetic Resonance Imaging (MRI), serum levels~     of BDNF, TNF-a, cortisol, IL-6, and IL-10, polysomnography, neuropsychological, psychiatric~     scales and questionnaires.~   "
49861|NCT02914249|"~     This study aimed to verify if combination of a low calorie diet and orange juice consumption~     results in weight loss and ameliorates metabolic obesity-related biomarkers.~   "
49862|NCT02914236|"~     Evaluation of the Aerin Medical Device used for the treatment of nasal obstruction.~   "
49824|NCT02914730|"~     In this cross-sectional study the investigators will examine two populations: young adults~     with (ages 18-35) and older adults (ages 65 and over) with diabetes who are on > 2 insulin~     injections per day. The sample size for this observational study will be up to 125 patients.~     The investigators will issue a Common Sensing GoCap bluetooth-enabled pen cap that fits on~     the end of Solostar Lantus and Apidra insulin pens; this pen cap registers the position of~     the insulin pen plunger and automatically sends confirmation of dose delivery to a smartphone~     app.~   "
49825|NCT02914717|"~     Ulcerative colitis (UC) is a chronic inflammatory condition causing continuous mucosal~     inflammation of the colon, which is accompanied by episodes of bloody diarrhoea and abdominal~     pain. Both infliximab and adalimumab have been used with success for moderate-to-severe UC~     refractory to conventional therapy. More recently, golimumab, another anti-TNF antibody, has~     been added to the treatment armamentarium.~      In the multi-centre, double-blind, placebo-controlled PURSUIT trial, patients with~     moderate-to-severe UC randomized to induction therapy with golimumab (200-100 mg, or 100-50~     mg at week 0 and 2) achieved clinical response, clinical remission and mucosal healing more~     frequent than patients randomized to placebo. In the PURSUIT maintenance trial, patients~     randomized to golimumab every four weeks (100 or 50 mg) maintained clinical response through~     week 54 significantly more often than patients randomized to placebo. Data on the use of~     golimumab in daily clinical practice are unavailable.~      The aim of the retrospective Belgian multi-centre BE-SMART trial is to evaluate the mid-term~     outcome of golimumab in patients with moderate-to-severe colitis. The primary endpoint will~     be steroid-free golimumab continuation at week 26. Secondary endpoints will include~     (steroid-free) clinical remission, (steroid-free) clinical response, (steroid-free) mucosal~     healing, (steroid-free) complete mucosal healing hospitalization-free survival, and~     colectomy-free survival.~   "
49826|NCT02914704|"~     MRI-guided high intensity focused ultrasound (MRI-HIFU) has been proven to be a safe and~     effective method in treating uterine fibroids and also adenomyosis. However, systematic~     studies on the effect of this treatment on factors affecting fertility are still lacking.~     Also quite little is known about body's systemic response to MRI-HIFU. Thus the aim of this~     study is to obtain more information on the systemic response of the body to the~     HIFU-treatment when treating non-malignant disease as well as to study the effect of MRI-HIFU~     on factors affecting fertility. Women with symptomatic uterine fibroids or adenomyosis and~     with no wish for further pregnancies will be selected for this study and treated using~     MRI-HIFU. The severity of symptoms will be assessed with UFS-QoL and the same questionnaire~     will also be used in follow-up 3, 6 and 12 months after treatment. Blood, urine and~     endometrium samples will be collected pre- and postoperatively and during follow-up 3, 6 and~     12 months after the treatment. From these samples detailed analysis of the immunological,~     inflammatory and hormonal response will be performed. As this is the first study in Finland~     of treating uterine fibroids and adenomyosis using MRI-HIFU, also a report about the efficacy~     of the MRI-HIFU in treating the uterine disorders will be published, and a key tool in~     assessing the treatment outcome would be the UFS-QoL questionnaire.~   "
49827|NCT02914691|"~     Background: SGLT2 inhibitors are the first antiglycaemic drugs with a direct renal action. A~     part from reducing blood glucose, systemic blood pressure and albuminuria are decreased,~     while natriuresis is increased.~      Previous research into urinary peptide patterns (proteomics) has revealed that patients in~     risk of progressive renal disease display a risk peptide pattern in their urine, ahead of~     decline in renal function. Furthermore a urinary proteome pattern is related to CVD risk.~      The long-term impact of dapagliflozin (dapa) treatment on renal parameters is unknown, but~     long term randomized trials are ongoing. By investigating the impact of dapa treatment on~     this peptide pattern, it will be determined whether this intervention can improve the urinary~     proteomic peptide pattern. In addition new knowledge regarding renal processes that the~     treatment influences is sought.~      The impact of treatment of urinary and tubular markers of oxidative stress and function~     (metabolomics) will be assessed. These markers are thought to represent one of several~     deleterious pathways involved in the pathology of diabetic renal disease, and here the impact~     dapa treatment will be investigated. Improvement of these markers of oxidative stress may~     indicate long-term benefit.~      Objective: The primary objective is to assess the impact of three months of treatment with~     dapa 10 mg once daily or placebo on renal proteomics pattern and other risk markers of~     diabetic comorbidity.~      Design: Double blinded, randomized, placebo-controlled crossover, single center study.~     Treatment period: 2 x 12 weeks.~      Patient population: 40 patients with type 2 diabetes recruited from Steno Diabetes Center in~     accordance with the study in- and exclusion criteria.~      Intervention: Dapa 10 mg daily vs. placebo. Endpoints: Primary outcome: To evaluate the~     effect of dapa treatment on urinary proteomic patterns in patients with type 2 diabetes,~     microalbuminuria and eGFR equal to or above 45 ml/min/1.73m2.~      Secondary endpoints are the effect of the intervention on other markers for tubular function,~     inflammation, endothelial dysfunction, microcirculation, kidney function, albuminuria,~     vasoactive hormones in plasma, and effect on global longitudinal strain as measured by~     echocardiography.~      Timeframe: Randomisation planned from June 2015, inclusion over the following 9 months. Last~     patient is expected to be completed October 2016. Data analysis completed December 2016,~     presentation autumn 2017 and publication early 2018.~   "
49828|NCT02914678|"~     In a previous study the investigators evaluated the apparent efficacy and safety of~     intravenous fentanyl administered by ambulance personnel and found that 58.4% (CI 56.4-60.4)~     out of 2348 prehospital patients treated with fentanyl still experienced moderate to severe~     pain [numeric rating scale (NRS, 0-10) > 3] at hospital arrival. The number of patients with~     possible fentanyl-related side effects was low.~      Therefore, the aim of the present study is to explore the efficacy and safety of a~     liberalized pain treatment protocol for ambulance personnel (a total of 3 μg/kg per~     transport) compared with existing restrictive protocol (a total of 2 μg/kg per transport).~     The investigators hypothesize that:~        -  A higher proportion of patients will experience sufficient pain relief at hospital~          admission (NRS < 4) using the liberalized protocol and~        -  There will be no differences in the proportion of potential fentanyl related~          side-effects are observed.~   "
49829|NCT02914665|"~     This is a phase 2 randomized, double-blind, placebo-controlled study to evaluate the cardiac~     and renal effects of short term treatment with elamipretide in patients hospitalized with~     congestion due to heart failure~   "
49830|NCT02914652|"~     The overall objective for this study is to test whether β2-agonists will affect the~     cardiopulmonary capacity of VSD-operated patients compared with un-operated VSD-patients and~     healthy age- and gender-matched controls.~   "
49831|NCT02914639|"~     The primary purpose of this study is to evaluate the safety and exploratory efficacy of~     SF0166 Topical Ophthalmic Solution in patients with Neovascular (wet) Age-related Macular~     Degeneration (AMD).~   "
49863|NCT02914223|"~     The main objective of the study is to investigate the rate and routes of elimination of~     cenerimod and the mass balance in urine, feces, and expired air~   "
49832|NCT02914626|"~     Neovascular glaucoma is a potentially blinding condition characterized by the growth of~     newvessels at the anterior part of the eye. This growth is driven by the overexpression of a~     protein called Vascular Endothelial Growth Factor (VEGF). That happens in diseases such as~     diabetic retinopathy or venous retinal occlusion, and lead to a fast increase in intraocular~     pressure (IOP). Traditional treatment include laser photocoagulation of the retina in order~     to decrease VEGF formation. The investigators postulate that the use of anti-VEGF~     intravitreal injections may accelerate recovery and decrease the need of surgery in cases of~     neovascular glaucoma.~   "
49833|NCT02914613|"~     The primary purpose of this study is to evaluate the safety and exploratory efficacy of~     SF0166 Topical Ophthalmic Solution in patients with Diabetic Macular Edema (DME).~   "
49834|NCT02914600|"~     The primary objective of this study is to observe the long-term safety of filgotinib in~     adults who have completed or met protocol specified efficacy discontinuation criteria in a~     prior Gilead-sponsored filgotinib treatment study in Crohn's disease (CD).~   "
49835|NCT02914587|"~     To investigate and compare the safety and effectiveness of the ARTAS™ System to manual hair~     follicle implantation method following a nine month period of post-procedure evaluation.~   "
49836|NCT02914574|"~     This study primarily aims to investigate arthrogenic muscle inhibition (AMI), an underlying~     mechanism in patellofemoral pain (PFP), which remain to date understudied. Although, studies~     have revealed that AMI needs to be eliminated before improvements in muscle strength can be~     achieved, to date quadriceps muscle inhibition in patients with PFP remains understudied. To~     date the influence of AMI on functional performance and the direct link to pain in patients~     with PFP remain unclear. This study aims to investigate the link between AMI to pain,~     functional performance and how an acute treatment can affect functional performance and pain.~   "
49837|NCT02914561|"~     The primary objectives of this study are to evaluate the safety and efficacy of filgotinib~     during induction and maintenance treatment of moderately to severely active Crohn's disease~     (CD) in participants who are biologic-naive and biologic-experienced.~      Participants who complete the study, or do not meet protocol response or remission criteria~     at Week 10 will have the option to enter a separate long-term extension (LTE) study (Gilead~     Study GS-US-419-3896).~   "
49838|NCT02914548|"~     The purpose of this study is to assess the efficacy and safety of OPA-15406 ointment in~     patients with atopic dermatitis.~   "
49839|NCT02914535|"~     The primary objective of this study is to observe the long-term safety of filgotinib in~     adults who have completed or met protocol specified efficacy discontinuation criteria in a~     prior Gilead-sponsored filgotinib treatment study in ulcerative colitis (UC).~   "
49840|NCT02914522|"~     The primary objectives of this study are to evaluate the safety and efficacy of filgotinib in~     the induction and maintenance treatment of moderately to severely active ulcerative colitis~     (UC) in participants who are biologic-naive and biologic-experienced.~      Participants who complete the study, or do not meet protocol response or remission criteria~     at Week 10 will have the option to enter a separate, long-term extension (LTE) study (Gilead~     Study GS-US-418-3899).~   "
49841|NCT02914509|"~     The objective of the study is to evaluate evaluate the safety and IOP lowering efficacy of~     OTX-TP, a sustained release travoprost drug product, placed in the canaliculus of the eyelid~     in the treatment of subjects with open-angle glaucoma or ocular hypertension~   "
49842|NCT02914496|"~     For many people living with type 1 diabetes it is a challenge to achieve good glucose~     control. Barely 20% reaches the goal level and many people experience self-care as complex,~     demanding and stressful. The purpose of this study is to evaluate the effect of a~     stress-management program on glucose control, self-care and psychosocial factors. The program~     is based on Acceptance and Commitment Therapy (ACT), a specific form of Cognitive behavior~     therapy (CBT). A total of 70 adult patients with type 1 diabetes from Ersta hospital will be~     recruited. Half of them will receive the intervention and the other half will continue with~     their regular diabetes care. A licensed psychologist specialised in CBT and a diabetes~     specialist nurse will be leading the intervention that is given in a group format. The~     program consists of seven 2-hour sessions given over 14 weeks. Glucose control, self care and~     stress will be measured at inclusion, after session four and seven, at six , 12 and 24 months~     and finally after 5 years~   "
49843|NCT02914483|"~     The Women's HARP study is a multi-center study focusing on women with clinical presentation~     of myocardial infarction (MI). Women will complete stress questionnaires following~     presentation to the medical center with elevated cardiac enzymes and abnormal~     electrocardiograms (ECGs). 2 months following MI, participants will be screened for the~     Stress Ancillary Study and enrolled if an elevated level of perceived stress is reported.~     After completing baseline assessments, participants will be randomized to Enhanced Usual Care~     (EUC) or stress management for 8 weeks. Participants will be followed for 6 months.~   "
49844|NCT02914470|"~     This is a single centre, 3+3, dose finding, open label, phase 1b clinical study of~     carboplatin and cyclophosphamide, in combination with atezolizumab.~   "
49845|NCT02914457|"~     The SYNSEQ study intends to assess the positive left ventricular dP/dt max achieved by~     multipoint LV pacing (either simultaneously or sequentially) in comparison to the response~     achieved by the current (standard) BiV pacing configuration in patients indicated/recommended~     for cardiac resynchronization therapy.~   "
49846|NCT02914444|"~     Monitoring data during anesthesia of surgical patient in the operation room will be collected~     and stored into the registry automatically. Patients' information and preoperative assessment~     from medical records will be included. Furthermore, intraoperative events will integrated and~     entered in the registry.~      The purpose of the registry is to establish an automatic and accessible database of surgical~     patients for further retrospective studies.~   "
49847|NCT02914431|"~     The purpose of this study is to determine whether personalized titanium plates can achieve~     better accuracy than CAD/CAM surgical splint in maxilla repositioning in orthognathic~     surgery, and evaluate the feasibility of this technique in clinical application.~   "
49848|NCT02914418|"~     This study will investigate how repetitive transcranial magnetic stimulation (TMS) using~     intermittent theta-burst stimulation (iTBS) paradigm affects sensorimotor dysfunction such as~     pain, spasticity, motor weakness and sensory loss. TMS is technique which allows non-invasive~     stimulation of the cortex, and can modulate activity of neurons. The purpose of this study~     will be to assess the feasibility of using TMS with iTBS paradigm to treat sensorimotor~     dysfunction in people with incomplete spinal cord injury affecting the upper limbs.~   "
49849|NCT02914405|"~     Neuroblastoma, the most common extra-cranial solid tumour in children, remains one of the~     major challenges in paediatric oncology. A promising way to further improve outcome in this~     disease appears to be the development of adjuvant therapeutic strategies. In this research~     the anti-GD2 antibody, which is a standard treatment, is to be combined with 131-l~     Metaiodobenzylguanidine (mlBG) and anti-Programmed Cell Death Protein 1 (anti-PD1) antibody~     Nivolumab - the investigated drugs - with the aim of generating sustained anti-neuroblastoma~     immunity. In particular it will be determined the safety and tolerability of the novel~     combination as well as documented any evidence of efficacy in paediatric patients with~     relapsed and refractory high risk neuroblastoma.~      This study is sponsored by the University Hospital Southampton and will take place in 4~     hospitals in the United Kingdom, Germany and USA. The estimated duration of the study is 2~     years, starting in December 2016.~      This is an adaptive study. Such design uses accumulating of data from the ongoing trial to~     modify aspects of the study (e.g. duration, number of treatments) without undermining its~     validity or integrity. There will be 3 cohorts of patients. As safety of Nivolumab is well~     established, Cohort 1 will assess its safety and tolerability in combination with 131-l mlBG.~     Cohort 2 will then add anti-GD2 to the drug combination, assessing safety and tolerability.~     Cohort 3 will escalate all 3 agents to the full 100% dose level to assure safety for expanded~     analyses of clinical and laboratory data at that dose level.~      Patients will initially be recruited into Cohort 1. Patients must have completed at least 12~     weeks of trial treatment without reaching a Dose Limiting Toxicity before a patient can be~     recruited to the next cohort.~      A minimum of 3 evaluable patients will be treated in cohorts 1-3. Assuming the full dose~     combination therapy (cohort) is tolerable, 15 evaluable patients will be treated.~   "
49850|NCT02914392|"~     The objective of this study is to research the relationship between maternal exposure to~     environmental factors and fetal congenital heart disease in a community-based case-control~     study.~   "
49851|NCT02914379|"~     The purpose of this study is to measure how much LY3337641 gets into the bloodstream and how~     long it takes the body to get rid of it. In addition, the safety and tolerability of the~     study drug will be evaluated.~      Participants will be admitted to a clinical research unit (CRU) the day before dosing.~     Participants remain confined to the CRU for at least 7 days. Participants may be discharged~     from the CRU any time after 7 days post-dose (Day 8), and up to a maximum of 21 days~     post-dose (Day 22).~      This study will last approximately 30 days for each participant, not including screening.~     Screening is required within 28 days prior to the start of the study.~   "
49852|NCT02914366|"~     The present study will test the hypothesis that the medication Ambroxol is safe and well~     tolerated and will improve cognitive and motor symptoms of Parkinson's Disease Dementia~     (PDD). Ambroxol has been shown to raise the levels of the enzyme beta-glucocerebrosidase~     resulting in lower the levels of the protein alpha-synuclein, both of which have been shown~     to improve cognition in mouse models. This will be a 52 week trial of Ambroxol in 75 patients~     with PDD. Patients will undergo clinical, neuropsychological and neuroimaging assessment~     throughout the study to assess changes.~   "
49853|NCT02914353|"~     This First-In-Human study will evaluate the safety and tolerability, pharmacokinetic profile,~     and pharmacodynamic effects of EP-7041, a novel Factor XIa inhibitor, following IV~     administration of single ascending doses in healthy normal volunteers, and following~     continuous IV infusions of multiple ascending doses in healthy normal volunteers.~   "
49854|NCT02914340|"~     This is a multicenter, prospective study designed to evaluate performance of the SVS in the~     REACH SVS control patients. The study is expected to enroll up to 20 patients at up to 12~     sites with up to 6 patients per site.~   "
49855|NCT02914327|"~     SNX-5422 is a prodrug of SNX-2112, a potent, highly selective, small molecule inhibitor of~     the molecular chaperone heat shock protein 90 (HSP90). Hsp90 inhibitors may overcome~     ibrutinib resistance in Mantle cell lymphomas and this study will investigate whether the~     addition of SNX-5422 to an established dose of ibrutinib will result in the removal of~     mutated BTK from blood mononuclear cells and/or prevents or delays disease progression of~     subjects with CLL~   "
49856|NCT02914314|"~     The purpose of this study is to evaluate the pharmacokinetics (PK) of an oral suspension of~     perampanel given as an adjunctive therapy and to generate preliminary safety and efficacy~     data in pediatric participants, ranging from 1 month to less than 24 months of age, with~     epilepsy.~   "
49857|NCT02914301|"~     Prenatal care is defined as preventive healthcare characterized by regular check-ups by~     doctors or midwives to treat and prevent potential health problems throughout the course of~     the pregnancy. The investigators propose that a mobile app for prenatal care has the~     potential to provide patient-tailored, risk-appropriate prenatal educational content and may~     facilitate vital sign and weight checks between visits. The investigators describe the~     methods used to develop and test the effectiveness of a mobile app for prenatal care to~     safely reduce the number of in-person visits to the obstetrician (OB) compared to standard of~     care.~   "
49858|NCT02914288|"~     Intracranial artery disease has been more detected with development of HR-MR. HR-MR can~     depict vascular wall directly and give us more information beyond the pre-existing imaging~     modalities such as digital subtraction angiography, magnetic resonance angiography, computed~     tomography angiography. Hence, HR-MR is considered to become promising imaging modality for~     intracranial artery disease and many studies have been published recently. However, there was~     not enough to differentiate various intracranial artery disease such as atherosclerosis,~     dissection, moyamoya disease, vasculitis, reversible vasoconstriction syndrome. In real~     clinical arena, intracranial artery disease is too difficult to diagnose and distinguish~     among the disease. Of the disease, usefulness of HR-MR has been consistently published in the~     detection and diagnosis of intracranial artery dissection recently. HR-MR seems to be the~     most important and reliable imaging method in intracranial artery dissection as of now.~     Therefore, intracranial artery dissection is necessary to study using HR-MR. Intracranial~     artery dissection is dynamic vascular pathology. The geometric change is the most common~     among intracranial artery disease. However, there was no report about the geometric change in~     HR-MR. The investigators acquired retrospective data about the natural course of intracranial~     artery dissection in HR-MR and are preparing for publishing an article. However, the data is~     not prospective and not intraindividual comparison. Therefore, reliability is not enough to~     convince the natural course. If the investigators got prospective and intraindividual data,~     definite natural course of intracranial artery dissection could be acquired and would be~     helpful to diagnose the dissection and differentiate from other vascular pathologies. The~     prospective longitudinal information from this study could guide us as the important map on~     the confusing HR-MR findings. The protocols for imaging are as follows: initial (optional), 1~     month, 3 month, 6 month (optional), 12 month.~   "
49859|NCT02914275|"~     This is a study to assess the immune (antibody) response and safety of a Seqirus split~     virion, inactivated Quadrivalent Influenza Vaccine (Seqirus QIV), in comparison with a US~     licensed 2016/2017 Quadrivalent Influenza Vaccine (comparator QIV) in a healthy pediatric~     population 6 months through 59 months of age.~   "
49860|NCT02914262|"~     This will be a double-blind, randomized, placebo-controlled, single ascending dose, Phase I~     study in healthy male subjects.~   "
49864|NCT02914210|"~     The goals of this research study are the following:~        1. To compare the effects of tele-rehabilitation-supported physical therapy versus~          traditional home and/or clinic-based physical therapy for total knee replacement (TKR)~          on 90-day health service use costs.~        2. To compare tele-rehabilitation-supported physical therapy and traditional physical~          therapy on patient-centered outcomes~        3. To explore whether individual patient characteristics are associated with differential~          improvement from 6 to 12 weeks assessed by patient-reported outcomes.~   "
49865|NCT02914197|"~     To trial the provision of full information on the benefits and risks of mammography in women~     that are eligible for breast screening. The knowledge many women have of mammography is not~     reflective of the recent change in evidence; it is often missing information on~     over-diagnosis and over-detection. Women tend to overestimate their risk of breast cancer and~     the benefits of breast screening. In addition, universal breast screening programs are biased~     towards emphasizing screening. However, a mammogram is not a perfect test and there is no~     right or wrong decision about whether to have a screening mammogram. It is an individual~     woman's decision to make. To understand the effect of changing information to reflect the~     potential for over-diagnosis and over-treatment, we will carry out a pragmatic controlled~     trial of implementation of balanced information on mammography in family practice.~   "
49866|NCT02914184|"~     The purpose of this study is to evaluate the clinical consistency of three production lots of~     the Porcine circovirus (PCV)-free liquid formulation of oral live attenuated human rotavirus~     (HRV) vaccine and to evaluate the PCV-free liquid formulation of HRV vaccine as compared to~     the currently licensed lyophilised formulation of the HRV vaccine in terms of immunogenicity,~     reactogenicity and safety when administered as a two-dose vaccination in healthy infants~     starting at age 6-12 weeks. No new subjects will be enrolled in the extension phase of the~     study~   "
49867|NCT02914171|"~     The objective of this study is to determine the safety and feasibility of autologous~     mononuclear cells (MNS) collected from bone marrow (BM) and using an add-on intramyocardial~     delivery for individuals with Ebstein anomaly undergoing surgical intervention compared to~     the control group undergoing the same surgical procedure without cell delivery. This add-on~     procedure has the potential to foster a new strategy for individuals with congenital heart~     disease.This is an open-label study of autologous MNC derived from bone marrow with a 2-year~     follow-up to document 1) incidence and severity of adverse event and 2) monitor changes in~     cardiac structure and function.~   "
49868|NCT02914158|"~     The objective of this study is to compare the curative effects in patients under the age of~     35 with hormone receptor positive breast cancer and high recurrent risk factors including~     large tumor or metastatic lymph nodes randomized to ovarian function suppression (OFS) plus~     aromatase inhibitors or OFS plus tamoxifen as adjuvant endocrine therapy, and explore the~     differences of curative effects between different subtypes to provide direct evidence for~     treatments of young breast cancer patients.~   "
49869|NCT02914145|"~     In line with the global and regional efforts towards malaria elimination, a five year program~     was established to assist the NMCP in adopting targeted evidence-based elimination plans~     through a 'learn by doing' strategy. The project aims to generate knowledge as data is~     generated to inform the programmatic aspects of the elimination plan, most importantly how to~     clear malaria parasites from the asymptomatic reservoir.~   "
49870|NCT02914132|"~     The purpose of this study is to determine whether the Seraph® 100 Microbind® Affinity Blood~     Filter (Seraph 100) is safe in the treatment of dialysis patients with bacteremia.~   "
49871|NCT02914119|"~     Aim: To explore~        -  the frequency of use of objective neuromuscular monitoring for assessment of depth of~          neuromuscular blockade in general anaesthesia~        -  the incidence of residual neuromuscular blockade, and~        -  the timing of reversal of the neuromuscular blockade at the end of anaesthesia.~      We will collect data from 7 Danish anaesthesia departments, using data from the Anaesthesia~     Information Management System (AIMS).~   "
49872|NCT02914106|"~     Despite several scientific and technological advances, there is no single neuroprotective~     treatment that can reverse the brain damage after acute ischemic stroke (AIS). Neuroactive~     steroids are cholesterol-derived hormones that have the ability to modulate the normal and~     pathologic nervous system employing genomic and non genomic mechanisms.~      In this work, we first investigated if AIS affects the plasma concentration of five~     neuroactive steroids (cortisol, estradiol, progesterone, testosterone and 3-alpha~     androstenediol glucuronide). Second, we studied if levels of circulating steroids associate~     with neurological, cognitive and functional outcome in a cohort of 60 to 90 year-old male and~     female patients with AIS.~      For this purpose, we recruited patients who were hospitalized at the Emergency Room of the~     Central Military Hospital within the first 24 hours after stroke onset. We designed two~     experimental groups, each one composed of 30 control subjects and 30 AIS patients, both males~     and females. The assessment of neurological deficit was performed with the NIHSS and the~     tests used for the functional and cognitive status were: (1) modified Rankin Scale; (2) Photo~     test and (3) abbreviated Pfeiffer's mental status questionnaire.~   "
49873|NCT02914093|"~     The overall objective of the study is to investigate the feasibility of home based~     inspiratory muscle training (IMT) on chronic hypercapnia in patients with severe COPD, and to~     examine the relationship between inspiratory muscle strength and carbon dioxide level.~   "
49874|NCT02914080|"~     Social isolation and loneliness of the elderly have become major public health problems,~     because of the deleterious consequences if not lethal they can generate.~      Because of frequent resignation to these phenomena, support must be given to all means of~     prevention to prevent or at least mitigate their impacts. It appears from the literature that~     are isolated or living as they have adjustment difficulties which are linked to fragility. If~     geriatric frailty have been defined to date in somatic and cognitive criteria, psychological~     fragility criteria have been little discussed outside of psychiatric disorders (depression,~     anxiety disorders in particular).~      This study aims to test in the elderly in isolation psychological fragility questionnaire and~     to study the statistical qualities and relations with socio-demographic variables,~     environmental and other known vulnerabilities.~   "
49897|NCT02913781|"~     Cases which undergone ICSI before with failure of fertilization will do another ICSI cycle~     with removal of the polar body just before the ICSI procedure and sperm injection at the site~     of polar body removal. This study group will be evaluated with another group with the classic~     ICSI procedure~   "
49875|NCT02914067|"~     The investigators will focus on two cohorts of brain tumor patients aged, 4-18 years, to~     answer two critical questions: 1) Can the investigators acquire high quality data relevant to~     cognitive function during the peri-diagnostic period and, 2) can the investigators develop~     predictive models for cognitive outcomes using serial examination of functional imaging and~     cognitive function. Any patient with a newly diagnosed brain tumor aged 4-18 will be eligible~     for enrollment in cohort 1. Only patients with previously diagnosed tumors of the posterior~     fossa will be eligible for cohort 2. The rationale for of the focus on these patients is that~     first, the posterior fossa is the most common location for pediatric brain tumors and~     therefore this focus will impact the largest segment of this patient population. Second,~     three tumors commonly occur here, medulloblastoma, ependymoma and pilocytic astrocytoma.~     These are treated with surgery, radiation and chemotherapy (medulloblastoma), surgery and~     radiation therapy (ependymoma) or surgery only (pilocytic astrocytoma). Thus, this focus will~     provide a platform to analyze the impact that different tumor types and different standard~     treatments have on cognitive dysfunction. Finally, the fact that all subjects will have~     tumors of the same brain region will control for the effect that tumor location will have on~     cognitive testing and rsfcMRI. Here, repeated evaluations on and off therapy will provide the~     necessary data points to establish trajectories of cognitive development and recovery in this~     population.~   "
49876|NCT02914054|"~     In this prospective, randomized, controlled clinical trial investigators' aim was to compare~     the efficacy and the adverse effect of 3 therapy cycles of HD-DXM versus conventional~     treatment with PDN for untreated adult patients with ITP. In this study standardized criteria~     and definitions were used according to consensus international working group guideline for~     ITPto compare clinical outcomes of the two corticosteroid treatment regimens and determine~     the superior regimen as a first line strategy for new primary ITP in adults~   "
49877|NCT02914041|"~     Are the KypDisT and conventional C7WD are practical, valid, reliable, and effectiveness of~     the tools to discriminate the functional ability impairments relating to kyphosis when~     compare with gold standard (Cobb's method), and compare among physical therapy, VHS and~     caregiver?~   "
49878|NCT02914028|"~     Inguinal hernia repair with mesh has a high incidence of postoperative chronic pain.~     Transversus abdominis plane block is a current intervention to support postoperative~     analgesia, however it is recently in research area how to be applied in different surgical~     areas to be more effective than intravenous opioids. Subcostal transversus abdominis plane~     block is not advised but has not been studied to be effective for postoperative analgesia in~     inguinal herniography patients.~      This study aims to research the effect of subcostal transversus abdominis plane block in~     subacute postoperative pain after inguinal hernia repair~   "
49879|NCT02914015|"~     This prospective, randomized study, control study aims to compare the analgesic effect,~     opioids consumption, quality of recovery, length of hospital stay and et al. between~     unilateral continuous quadratus lumborum block (QLB) and intravenous patient-controlled~     analgesia (IPCA) alone in patients undergoing hepatectomy with right J-shape subcostal~     incision.~   "
49880|NCT02914002|"~     Comer en Familia is a psychoeducational intervention in nutrition aimed to improve~     nutritional status in families, particularly mothers and caregivers of children between the~     ages of 5 and 13 years and their children through providing healthy cooking lessons in their~     communities where the optimal preparation and use of local foods based on vegetables is~     promoted at the same time the importance of cooking at home and eating as a family is~     highlighted.~   "
49881|NCT02913989|"~     Abstract: Tobacco dependence remains one of the primary health care concerns worldwide.~     Attitude of healthcare professionals towards smoking is crucial for any long-term prevention~     and smoking cessation program.~      Objectives: Analyze smoking habits of medical doctors from a central hospital in Lisbon~     (2014), comparing results between medical versus surgical specialities. Results were compared~     with those obtained in 1999.~      Design and setting: A voluntary and anonymous questionnaire was distributed to all physicians~     for a period of 4 months. The questions included sociodemographic data, smoking habits~     characterization, attitudes towards smoking, importance attribute to smoking cessation~     programme in the hospital and knowledge of the 2008 country law.~      Participants: All medical doctors working in the central hospital studied between 1/1/2014~     and 30/6/2014 Outcome measures: The primary outcome measure was to characterize the smoking~     habits of medical doctors. Secondary outcomes included comparison of results between surgical~     and medical groups and with those obtain in a similar study in 1999.~   "
49882|NCT02913976|"~     The aim of this study is to demonstrate that the application of Kinesio Taping on a~     myofascial trigger point in the trapezius muscle able to cause a decrease of the pain and an~     increase of the cervical range of motion in patients diagnosed with cervical pain.~   "
49883|NCT02913963|"~     The aim of this study is to demonstrate that the application of Kinesio Taping on a~     myofascial trigger point in the trapezius muscle able to cause a decrease of the trigger~     point pain and an increase of the cervical range of motion in asymptomatic subjects~   "
49884|NCT02913950|"~     There is a need to develop a stool scale for baby's and toddlers who are not potty-trained~     yet. The investigators try to get a uniform and approved Bristol stool scale for children who~     ware diapers.~   "
49885|NCT02913937|"~     The aim of this study is to compare the effect of passive ultrasonic irrigation versus needle~     irrigation on post-operative pain and healing in patients with permanent posterior teeth with~     apical periodontitis treated in a single visit.~   "
49886|NCT02913924|"~     The proposed protocol is a double-blind, placebo-controlled inpatient and outpatient~     study,looking at the clinical treatment of cannabis use disorder.~      The treatment study is a total of 12 weeks. There will be two options offered to participants~     for week 1 of the treatment study. 1) Patient will go inpatient for 5 nights and after~     discharge from the inpatient phase will complete the 11-weeks of outpatient treatment or 2)~     patients who cannot complete the inpatient phase due to work or other obligations will~     complete the treatment 12-week study outpatient. 80 patients seeking treatment for cannabis~     use disorder will be enrolled into either the inpatient/outpatient or only outpatient study.~     This combined design will provide a comprehensive understanding of clonazepam's effects on~     individuals with cannabis use disorder across a range of outcome measures while also testing~     the medication's ability to prevent relapse in cannabis-abstinent patients.~   "
53278|NCT02869568|"~     Database of Institut Paoli-Calmettes patients diagnosed with ovarian cancer~   "
49887|NCT02913911|"~     -  Does the utility of external feedback in terms of goal-directed LLL approach during STS~          training immediately improve functional ability relating to walking in ambulatory~          patients with SCI?~        -  Does the utility of LLL feedback improve functional ability relating to walking in~          ambulatory patients with SCI after 2-week training?~   "
49888|NCT02913898|"~     This study will assess learning bias (the tendency to learn more from negative relative to~     positive outcomes) at baseline in 3 groups of participants (currently depressed, previously~     depressed and never depressed). It will then try to modify this bias using a simple~     computerised training task completed at home daily for 2 weeks. Outcome measures include~     symptoms of depression, cognitive measures (i.e. accuracy and reaction time during completion~     of tasks), pupillometry measures and salivary cortisol.~   "
49889|NCT02913885|"~     The aim of this study is to compare the effect of color change between remineralizing agent~     and guided enamel regeneration in treatment of white spot lesion after orthodontic treatments~   "
49890|NCT02913872|"~     What are the capacity and training needs in general practice to implement routine spirometry~     and eNO testing in children aged 5-16 years?~      Asthma is the commonest long-term disease of childhood in the United Kingdom (UK).~     Under-diagnosis and under-treatment of childhood asthma in general practice (GP) have been~     reported from several European countries including the UK. This can result in poor symptom~     control and increased risk of asthma related deaths.~      It has been suggested that both under- and over- diagnosis of childhood asthma in general~     practice could be improved by routinely using objective lung function testing for diagnosis~     and monitoring.~      The proposed objective lung function tests (spirometry and exhaled nitric oxide measurements~     - eNO) are already used routinely in UK hospitals, but are not usually available in general~     practice where most children are cared for.~      Why is it important? - Availability of these tests will help health professionals in general~     practice to look after children with asthma better, and hopefully improve asthma control.~      What will this study achieve? - Though it is believed that providing spirometry and eNO in~     general practice would be beneficial, there is little data on how this can be achieved. This~     study will employ both qualitative and quantitative measures in order to evaluate the~     resources required to implement routine spirometry and eNO testing for children in primary~     care; and to investigate the impact this would have on diagnosis in children with suspected~     asthma.~      How? - The investigators will work with general practices in and around Leicestershire, UK.~     Firstly, to identify what the barriers are to implementing these tests, and secondly to train~     the practices to perform and interpret spirometry and eNO independently in children.~      Children with suspected or previously diagnosed asthma will be invited for review and lung~     function testing. The investigators will record the time it takes to train general practices~     to perform and interpret spirometry and eNO independently, and the additional clinic capacity~     required to provide these tests.~   "
49891|NCT02913859|"~     PART I~      Hormone therapy with or without definitive radiotherapy in metastatic prostate cancer~      The goal of this clinical study PART I is to determine impact of radiotherapy treatment in~     combination with standard androgen deprivation therapy comparing with androgen deprivation~     therapy alone at controlling metastatic prostate cancer. The primary objective: to determine~     disease progression free survival in man with metastatic (M1) prostate cancer (PC) undergoing~     androgen deprivation therapy with or without definitive radiotherapy of the primary tumor.The~     secondary objective: to determine disease progression (local, bone marrow, visceral) in men~     with metastatic prostate cancer (M1PC) undergoing systemic therapy with/without definitive~     radiotherapy of the primary tumor, to determine expression in number of genes analysed 8: 2~     housekeeping genes; integrin subunits αv, β3, β5, α4β1 ; 3 EMT markers N-cadherin,~     E-cadherin, vimentin before radiotherapy, after radiotherapy and at the time of the disease~     progression , to determine plasma serotonin (5HT, 5 hydroxytryptamine). Subgroup analysis in~     locally advanced prostate cancer (serves as a control group for integrins analysis): to~     determine expression in number of genes analysed 8: 2 housekeeping genes; integrin subunits~     αv, β3, β5, α4β1 ; 3 epithelial-mesenchymal transition (EMT) markers N-cadherin, E-cadherin,~     vimentin before radiotherapy, after radiotherapy and at the time of the disease progression.~      PART II~      Identification of genetic determinants of disease progression and castrate resistance in~     metastatic prostate cancer.~      The goal of this clinical study PART II is to assess feasibility of genomic testing in the~     multidisciplinary clinical management of metastatic prostate cancer, to gain insight in~     specific genomic signature(s) of progressive metastatic prostate cancer in the natural course~     of disease spanning from primary tumor to metastases, to test if 'treatment selection' and/or~     'treatment adaptation' as means of evolutionary pressures represent the mechanistic models of~     castrate resistance and ultimate treatment failure following course of androgen deprivation~     therapy (ADT).~   "
49892|NCT02913846|"~     Denutrition is defined as a measurable decrease in functions and/or as change in the body~     composition, associated with a worsening of the prognosis of the underlying medico-surgical~     pathology. It is induced by a deficiency in energy, proteins or any other micro or~     macronutrient and is the result of malnutrition, itself caused by a poor diet or a metabolic~     disorder.~      According to the National Nutrition and Health Plan for Belgium, denutrition is an~     independent risk factor for the increase of complications, morbidity and mortality rates,~     average length of hospitalisation and global medical care cost. It is necessary to invest in~     the prevention of denutrition as the costs of preventive measures are lower than the cost of~     treating a denutrished patient.~      The Belgian financing system of hospitalisation days is based on the structure of the treated~     pathologies, the age of the patient and the geriatric features of the patient. It encourages~     all hospitals to lower the length of hospitalisation to the national average for all these~     criteria. As a consequence, there is a mounting tendency to shorten the average length of~     stay within the hospital.~      The so-called 'Sp' hospital departments occupy a specific place within the organisation of~     Health Services in Belgium. They are specialized in the treatment and rehabilitation of~     patients with cardiopulmonary, neurological, locomotor, psycho-geriatric and chronic~     diseases. These services act as an extension of acute services (continuity of acute~     hospitalisation) but also as a first entry point for the medical care of patients with~     various specific diseases (multiple sclerosis, psycho-geriatric disorders, chronic pulmonary~     disorders...).~      The financing of the Sp departments is, as opposed to the financing of other departments, not~     linked to the patient length of stay. However, an increase in hospitalization duration~     decreases the rate of admissions and the possibility to accept patients coming from acute~     hospital units.~      The aim of the study is to evaluate the influence of denutrition of patients hospitalized in~     an Sp department on the length of revalidation stay, the associated costs and the patient's~     functional autonomy.~   "
49893|NCT02913833|"~     The financing of the Belgian hospitals is based on a system taking into account the length of~     hospitalization of a given patient according to his/her pathology, his/her age and his/her~     geriatric characteristics. This system encourages all hospital to lower the hospitalization~     duration to the national average for these criteria. This results in better efficiency in the~     management of hospitalizations but also means a swifter transfer to structures exempted from~     this system such as revalidation units, nursing homes and psychiatric units. An assessment of~     the differences in the medical practice, in terms of quality and outcomes of care, is~     essential for any reform willing to reduce medical costs.~      Pain management is part of the quality indicators within hospitals. Pain is defined by the~     International Association for the Study of Pain as an unpleasant sensory and emotional~     experience, associated to present or potential tissue damage, or described in terms of such a~     damage. Several studies have showed that pain affects the quality of life and impacts the~     daily activities. Acute or chronic pain can cause adverse symptoms such as sleep disturbance,~     appetite loss, decreased concentration, mood changes and the disruption of familial, work and~     social activities. Pain might also slow down revalidation processes. A study performed by~     Aprile et al showed that pain negatively influenced the rehabilitation program of a quarter~     of the patients having had a stroke. The functional recovery was slower and the costs were~     higher.~      The aim of this study is to determine if the systematic evaluation of the pain of a patient~     hospitalized in a revalidation unit has an impact on his/her length of stay.~   "
49894|NCT02913820|"~     Changes in the ambient temperature (esp. warm to cold) as well as exercise are triggers for~     vasospasms and plaque rupture. Weather data (temperature, precipitation in general as well as~     snowfall and changes in atmospheric pressure) will be correlated with the incidence of~     myocardial infarctions.~   "
49895|NCT02913807|"~     This study will test the accuracy of computerized custom mandibular reconstruction to~     traditional methods of mandibular reconstruction using a vascularized osteocutaneous fibula~     flap.~   "
49896|NCT02913794|"~     Fimasartan and Rosuvastatin for hypertension and dyslipidemia control~   "
49898|NCT02913768|"~     Subarachnoid block is the preferred method of anaesthesia for caesarean section, but is~     associated with hypotension and bradycardia, which may be deleterious to both parturient and~     baby. Animal studies suggest that in the presence of decreased blood volume, 5-HT may be an~     important factor inducing the Bezold Jarisch reflex via 5-HT3 receptors located in~     intracardiac vagal nerve endings. In this study, the investigators evaluated the effect of~     ondansetron, as a 5-HT3 receptor antagonist, on the haemodynamic response following~     subarachnoid block in parturients undergoing elective caesarean section.~   "
49899|NCT02913755|"~     Acquired Brain Injury (ABI) is damage to the brain caused by a head injury or illness/disease~     such as stroke or aneurysm. ABI is often associated with poor awareness into ongoing symptoms~     of damage to the brain, which can be cognitive, physical, and psychological. A~     multi-disciplinary rehabilitation programme is recommended to help with such symptoms.~     However, without self-awareness of difficulties, people with ABI can have poor motivation to~     take part. The study aims to discover whether showing people a short 'preparatory' video~     about ABI rehabilitation has an effect on self-awareness, and their motivation to take part~     in rehabilitation offered to them.~      The study also aims to investigate the feasibility of using the preparatory video on a larger~     scale across inpatient ABI rehabilitation, by exploring whether staff find delivering the~     video easy to incorporate into routine practice.~      People invited to take part in the study will be recruited from a specialist inpatient brain~     injury rehabilitation unit (BIRT).~      People who are approached will be given information about what the study will involve, and~     can choose not to take part.~      Each participant will be asked to fill out a series of questionnaires. They will then be~     supported by staff to watch a short video every two/three days, over four weeks. Half of the~     participants will be shown the video right away, while the other half will wait two weeks, to~     allow for comparisons between the groups. The video will aim to improve understanding of the~     kinds of emotional and/or practical difficulties they may be experiencing, and will inform~     participants about what rehabilitation might be like. After they have regularly watched the~     video for four weeks both sets of participants will be asked to complete another set of~     questionnaires, and the staff will be asked to complete an evaluation of how they found~     delivering the video.~   "
49900|NCT02913742|"~     Mesial temporal lobe epilepsy (MTLE) is the most common cause of medication-resistant~     epilepsy in adults, and MRI-guided laser interstitial thermal therapy is a new approach to~     its surgical management; however, while LITT demonstrates fewer complications than~     traditional surgical techniques, it generates lower rates of seizure freedom. During~     traditional temporal lobectomy for MTLE, neurophysiologic intraoperative monitoring (NIOM)~     can be used to better identify epileptogenic tissue and guide resection. Our study proposes~     to investigate the utility of NIOM during LITT for MTLE. Subjects will be drawn from~     refractory mesial temporal lobe epilepsy patients determined to be candidates for LITT.~     During their LITT surgery, in addition to the placement of the stereotactic LITT probe,~     subjects will receive a second smaller stereotactic electrode for intraoperative monitoring~     of epileptic discharges before and after surgery. After surgery, at regularly scheduled~     follow-ups, patients will receive the Quality of Life in Epilepsy questionnaire (QOLIE-31-P),~     in addition to standard post-operative care. Endpoints will be surgical complications,~     fractional decrement in epileptiform discharges from pre- to post-ablation recordings, and~     surgical outcome at 6 months and one year. Analysis of severe complications will be expressed~     as a simple complication rate, for overall complications, severe complications, and~     hemorrhagic complications in specific. The relationship between fractional discharge~     decrement and outcome will be assessed by regression analysis. Risks of the study will stem~     from the placement of the stereotactic electrode for intraoperative monitoring, which~     represents a small incremental risk beyond typical LITT for MTLE.~   "
49901|NCT02913729|"~     Most of the local recurrences (LR) found after breast-conserving therapy are within or close~     to the tumor bed. This pattern of recurrence was confirmed by studies of breast conserving~     surgery without adjuvant irradiation and by the update of the NSABP B-06 trial. In the EORTC~     boost trial, however, 29% of all LR were found outside the area of the original tumor. Still,~     a recent review of Breast Conserving Therapy (BCT) trials showed that the site of local~     recurrences after BCT was mostly in the tumor bed, with less than 10% of LR elsewhere in the~     breast. This led to the concept of partial breast irradiation. With accelerated partial~     breast irradiation (APBI), a limited volume of breast tissue is irradiated, allowing for a~     higher dose per fraction compared to whole breast irradiation (WBI), which is favorable~     considering the low alpha/beta ratio, and thus higher sensitivity to high dose per fraction.~   "
49902|NCT02913716|"~     This study assesses the mass balance recovery, pharmacokinetics, metabolite profile and~     metabolite identification of defactinib.~   "
49903|NCT02913703|"~     Background and Significance: The peptide hormone ghrelin drives hunger and feeding behavior,~     making it a focus of obesity research. Released mainly by the stomach and proximal small~     intestine, ghrelin peaks prior to meals, potentially priming the gut for anticipated~     nutrients. After eating, ghrelin abruptly declines, with levels varying 2- to 3-fold between~     the fasted and fed states. Interestingly, in obesity and type 2 diabetes (T2D), this pattern~     is disrupted. Individuals with these disorders have chronically suppressed ghrelin levels and~     little variation before and after meals.~      Although ghrelin's preprandial rise and postprandial fall is a well-established phenomenon,~     its role in regulating glucose metabolism is unclear. In mice, increasing preprandial ghrelin~     levels improves glucose tolerance through enhanced glucagon-like peptide-1 (GLP-1) secretion.~     Ghrelin also stimulates GLP-1 secretion from mouse and human intestinal L-cells in vitro.~     These findings suggest enhanced postprandial GLP-1 as a novel role for the preprandial~     ghrelin surge. A ghrelin-incretin enteroendocrine axis could also explain the poor~     postprandial GLP-1 secretion and glucose tolerance in subjects with T2D, given their~     preprandial hypoghrelinemia.~      The investigators' preliminary data demonstrate that in humans, increasing circulating~     ghrelin to a supraphysiologic range worsened glucose tolerance, despite increased GLP-1~     secretion. The discrepancy between these findings and the ones from rodents could be due to~     difference in study design and/or species. For example, the investigators' study used a~     continuous ghrelin infusion, which resulted in elevated levels of ghrelin pre- and~     postprandially. Elevated postprandial ghrelin likely mitigated the positive effects of~     increased GLP-1 secretion by raising levels of glucagon and other counter-regulatory~     hormones.~      This study seeks to delineate the interactions between ghrelin and GLP-1 in the regulation of~     glucose tolerance, beta-cell function, and insulin sensitivity. The investigators hypothesize~     that increased preprandial ghrelin will enhance GLP-1 secretion and consequently improve~     glucose tolerance in healthy subjects and those with T2D. Confirmation of these hypotheses~     would advance the investigators understanding of the control of glucose homeostasis and have~     important clinical and therapeutic implications. Modulating ghrelin levels may provide a~     novel therapeutic strategy to improve glucose tolerance in individuals with T2D, which~     affects an estimated 350 million people worldwide.~   "
49904|NCT02913690|"~     This study aims to determine if tocotrienol rich fraction (TRF) supplementation can improve~     markers of inflammation, oxidative stress and blood lipids in Malaysian hemodialysis (HD)~     patients.~   "
49905|NCT02913677|"~     Recent studies showed the benefits of early initiation and advancement enteral feeds with~     daily increments in preterm infants on decreasing invasive infections and early achievement~     of full enteral feedings. But the data on enteral feeds of extremely low birthweight infants~     are limited. Preterm infants especially those <1250 gr birthweight are at increased risk of~     developing feeding intolerance and necrotizing enterocolitis (NEC) and so the initiation and~     the rate of increments of enteral feeds are usually uncertain issues for neonatologists.~   "
50143|NCT02910492|"~     Single-center study to evaluate the safety and efficacy of an investigational version of the~     enlighten™ 670nm laser for photo-rejuvenation.~   "
49906|NCT02913664|"~     Physical inactivity, high blood pressure and dyslipidemia are risk factors for Alzheimer's~     disease (AD) and vascular dementia. Importantly, these risk factors are modifiable with~     lifestyle changes, pharmacological treatment, or both. The rrAD study will determine effects~     of aerobic exercise training and intensive vascular risk reduction on cognitive performance~     in older adults who have high risk for AD.~   "
49907|NCT02913651|"~     Autonomic nervous system dysfunction has been described in narcolepsy with cataplexy~     affecting the sympathetic function. In this study the investigators analyzed whether altered~     diurnal and nocturnal cardiovascular control is present in idiopathic hypersomnia. Drug-free~     patients diagnosed with idiopathic hypersomnia and age-matched controls were included.~     Clinical data, 24-h polysomnography, heart rate variability and the heart rate response to~     spontaneous arousal are analyzed.~   "
49908|NCT02913638|"~     The purpose of this clinical study which is to evaluate the benefits of lactation support~     intervention, in conjunction with maternal nutritional supplementation during the last~     trimester to 12 weeks postpartum in comparison to pre- and postnatal care on 1) breast~     feeding practices (primary objective), and 2) cognitive development in children within 28~     months 16 days - 32 months 30 days (secondary objective).~   "
49909|NCT02913625|"~     Locoregional anesthesia provides several advantages over general anesthesia in terms of~     postoperative pain, decreased postoperative opioid needs and reduced recovery time for~     patients undergoing orthopaedic surgery.~      For upper limb surgery, the coracoid infraclavicular brachial plexus block is generally~     preferred because of its simplicity and effectiveness but, needle visibility remains a~     challenge because of the angle between the ultrasound beam and the needle.~      The retroclavicular approach for brachial plexus anesthesia requires an angle between the~     needle and the ultrasound beam that is less steep than the angle required to perform an~     infraclavicular coracoid block. This approach has already been proven effective and safe in~     the past.~      The general objective is to provide a formal comparison between the retroclavicular approach~     and coracoid infraclavicular approach for brachial plexus anaesthesia. This study will~     delineate the differences between the two techniques.~   "
49910|NCT02913612|"~     Multi-center, double-masked randomized, efficacy, safety and pharmacokinetic (PK) study.~   "
49911|NCT02913573|"~     Patients undergoing total mastectomy with immediate breast reconstruction with a tissue~     expander or implant under general anesthesia will be randomly assigned to the addition of a~     pectoral nerve block or no regional block. Post-operative pain, nausea/vomiting scores will~     be assessed.~   "
49912|NCT02913547|"~     The objective of the study is to evaluate the safety, efficacy and usage compliance of the~     home-use device Silk'n HST for self-treatment of periorbital wrinkles and skin laxity and~     improvement of skin appearance.~   "
49913|NCT02913534|"~     The aim is to identify in patients with brain metastases the predictive factors of overall~     survival, survival without local recurrence and survival with progression-free brain~     metastases after complementary whole brain radiotherapy.~   "
49914|NCT02913521|"~     A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Three-Arm, Multi-Site Study~     to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Topical Gel 1% (Hi-Tech~     Pharmacal Co., Inc.) With Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% (Novartis) in~     Patients With Osteoarthritis of the Knee~   "
49915|NCT02913508|"~     The purpose of this study is to assess the bioavailability and pharmacokinetics (PK) of~     multiple doses of vedolizumab subcutaneous (SC) compared to vedolizumab intravenous (IV).~   "
49916|NCT02913495|"~     The purpose of this study is to evaluate the two suggested therapies for prevention of~     recurrent preterm birth (PTB) in women with a prior spontaneous preterm birth, vaginal and~     intramuscular progesterone to determine whether vaginal progesterone is superior to~     intramuscular progesterone in the prevention of recurrent preterm birth.~   "
49917|NCT02913482|"~     Open-label, multi-center clinical study is to assess the safety, tolerability,~     pharmacokinetic (PK), pharmacodynamics (PD), and efficacy of RO7034067 in infants with Type 1~     spinal muscular atrophy (SMA). The study consists of two parts, an exploratory dose finding~     part (Part 1) and a confirmatory part (Part 2) which will investigate RO7034067 for 24-months~     at the dose selected in Part 1.~   "
49918|NCT02913469|"~     Percutaneous coronary intervention(PCI) has become the first choice for STEMI~     patients.According to the current guidelines,dual antiplatelet therapy with a P2Y12 receptor~     inhibitor and aspirin ,and intravenous injection of morphine therapy for chest pain relief in~     necessity play a pivotal role in the treatment of patients with ST elevation myocardial~     infarction before primary percutaneous coronary intervention.And ticagrelor is recommended in~     patients with ST segment elevation myocardial infarction undergoing PCI, with class IB~     indication.Therefore coadministration of morphine and ticagrelor are commonplace.Currently,~     some studies have found that morphine delayed and attenuated exposure to ticagrelor,but it is~     not clear of the pathogenesis of it.Some researchers say that morphine results in a weaker~     and retarded antiplatelet effect of ticagrelor in STEMI patients before PCI by inhibition of~     gastrointestinal peristalsis and causing vomiting.The study is aimed at exploring whether~     morphine delay and attenuate exposure to ticagrelor and its antiplatelet effect.In addition,~     the trial will explore the possible mechanism which morphne delay and attenuate exposure to~     ticagrelor in patients with ST-segment elevation myocardial infarction before PCI.~   "
49919|NCT02913456|"~     This disease registry is a prospective, multicenter non-interventional study designed to~     observe anti-cancer treatment regimens and clinical outcomes in participants with~     HER2-positive unresectable LA/mBC. Diagnosis of unresectable LA or mBC can be up to 6 months~     old prior to registry enrollment.~   "
49920|NCT02913443|"~     This is a Phase I, open-label, multicenter study designed to assess the safety and~     tolerability of RO7051790 in participants with relapsed ED SCLC. This dose escalation and~     expansion study plans to determine the maximum tolerated dose and/or optimal biological dose~     as a recommended Phase 2 dose for RO7051790, based on the safety, tolerability,~     pharmacokinetic and pharmacodynamic profiles observed after oral administration of RO7051790.~   "
49921|NCT02913430|"~     To study progression free survival for treatment with Fulvestrant compared to treatment with~     tamoxifen in Metastatic Breast Cancer.~   "
50213|NCT02909582|"~     Hypothesis: A Pfannenstiel cesarean skin incision placed under the pannus (should a pannus~     exist) will have a higher maternal morbidity composite rate than a Cohen cesarean skin~     incision placed above the pannus (should a pannus exist).~   "
49922|NCT02913417|"~     Reports to date show limited efficacy of immunotherapy for uveal melanoma. Recent~     experimental and clinical evidence suggests synergy between radiation therapy and~     immunotherapy. The investigators will explore this synergy with a feasibility study of 18~     patients with uveal melanoma and hepatic metastases who will receive SirSpheres Yttrium-90~     selective internal hepatic radiation followed by immunotherapy with the combination of~     ipilimumab and nivolumab.~   "
49923|NCT02913404|"~     The purpose of this study is to asses functional biomechanical outcomes and patient reported~     outcome measures following single bundle ACL reconstruction (ACL-R) compared to single bundle~     ACL reconstruction and extra articular tenodesis (ACL-R+EAT).~   "
49924|NCT02913391|"~     Cardiac surgery can evolve with complications in the postoperative period, atelectasis and~     hypoxemia are the major pulmonary dysfunctions. They can lead to a prolonged length of stay~     in the hospital, increasing morbidity and mortality. In order to prevent or reduce such~     complications noninvasive ventilation (NIV) has been used in the postoperative period in a~     prophylactic and therapeutic way. The use of positive end-expiratory pressure (PEEP) is~     widely practice in intensive care unit (ICU), being used in patients under mechanical~     ventilation, NIV and exercises with intermittent positive pressure. The recruitment maneuver~     (RM) consists of sustained increase of pressure in the airway using PEEP in individuals with~     hypoxemia, in order to minimize the deleterious effects from alveolar collapse, providing a~     more homogeneous ventilation of the pulmonary parenchyma increasing the pulmonary area~     available for gas exchange and, consequently, arterial oxygenation. In recent years the~     increase in the application of PEEP in cardiac patients under has shown great benefits and~     the use of NIV to improve oxygenation by the reversal of atelectasis is already used and~     recommended in hospital routine. Despite NIV being used in great proportion, the relevant~     literature is poor in showing studies with NIV associated with RM in postoperative period of~     cardiac surgery. Therefore, the aims of this study are to evaluate if the use of NIV~     associated with RM improves oxygenation and if it can be safely applied in coronary artery~     bypass grafting (CABG) with cardiopulmonary bypass (CPB) postoperative patients.~   "
49925|NCT02913378|"~     This is a randomized trial comparing conservative with surgical treatment (with open~     reduction and locking plate fixation) for proximal humeral fractures in patients aged more~     than 60 years.~   "
49926|NCT02913365|"~     The study consist of a retrospective analysis of the etiologies, investigations and outcomes~     of patients presenting between 2005 to 2010 with hemoptysis in a North-American Tertiary~     center.~   "
49927|NCT02913352|"~     Randomized clinical trial, parallel 1:1, comparing Latarjet to Modified Eden-Hybinette (iliac~     bone crest + capsular repair) for recurrent traumatic anterior glenohumeral dislocation.~   "
49928|NCT02913339|"~     Cardiovascular disease (CVD) accounts for approximately one-third of Argentina's deaths.~     Despite the availability of management and treatment for CVD which is offered to the~     uninsured population at government primary care clinics (PCCs), the rates at which those at~     risk are screened, identified and referred to the clinics are very low. This study will~     determine if providing CHWs with an mHealth application using an integrated, inexpensive and~     validated screening tool on cell phones for screening in the community which is linked with~     the PCC scheduling system wirelessly allowing the CHWs to make appointments at the time they~     identify high-risk individuals, will increase the number of referral and follow-up visits~     that patients attend at the PCCs.~   "
49929|NCT02913326|"~     This is a multi-center, prospective, international, randomized (1:1), open-label study with~     two parallel groups. This phase III study is planned to investigate the efficacy and safety~     of dabigatran etexilate versus dose-adjusted warfarin on a net clinical benefit endpoint of~     major bleeding (ISTH criteria) and new venous thrombotic event (VTE) (primary endpoint) with~     blinded endpoint adjudication.~   "
49930|NCT02913313|"~     The purpose of this study is to evaluate the safety and effectiveness of experimental~     medication BMS-986207 by itself and in combination with Nivolumab in solid cancers that are~     advanced or have spread.~   "
49931|NCT02913300|"~     Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS -TBNA) is commonly~     performed for diagnosis of mediastinal pathologies. The procedure can either be performed~     under general anaesthesia or under moderate sedation with topical anaesthesia. Most patients~     tolerate the procedure well although cough is often reported as a distressing symptom.~     Topical lignocaine is administered during bronchoscopy for local anaesthesia. There is no~     literature on the efficacy of lower concentrations (1%) versus a higher (2%) during EBUS~     TBNA. This study would help to determine whether 1% lignocaine is as effective as 2%~     lignocaine for airway anaesthesia during EBUS-TBNA.~   "
49932|NCT02913287|"~     The aim of the overall project is to investigate the potential of a combination of~     commercially available nutraceuticals produced by Marigot Ltd (natural seawater derived~     mineral-rich AquaminMG and seaweed-derived mineral-rich food supplement AquaminTM (FDA GRAS~     000028) isolated from Lithothamnion species), as safe and effective supplements to promote~     cognition in the aged brain.~   "
49933|NCT02913274|"~     Dysfunctions such as tight stenosis or thrombosis in haemodialysis vascular accesses are the~     leading cause of hospitalisation (20%) and morbidity in chronic haemodialysis patients~     incurring significant related costs estimated at over one billion dollars in the USA.~      Dysfunctions of these vascular accesses are generally treated by conventional angioplasty as~     this is the least invasive procedure, the alternative being revision surgery. Angioplasty~     uses an inflatable balloon of various diameters. Different types of angioplasty balloons may~     be needed to break fibrous venous stenosis, in particular high-pressure balloons (20 atm) or~     cutting balloons. These angioplasty procedures which are often painful during dilation have a~     high technical success rate (90-97%) but a poor 1-year patency rate, varying between 26 and~     64% depending on the team and a mean rate estimated at 40% for the studies including the~     larger number of patients, some of whom requiring several procedures.~      These invasive repeated procedures impair the quality of life of these patients with~     end-stage renal disease who are on permanent dialysis or awaiting a kidney transplant and for~     whom vascular access patency is vital.~      Due to their traumatic effect on the vessel wall, these procedures induce cell proliferation~     processes that retrigger neointimal hyperplasia the very act of preserving the haemodialysis~     access is the key factor in development of a new stenosis and hence a vicious circle of~     stenosis-angioplasty.~      For the past few years, angioplasty balloons delivering anticancer drugs (Paclitaxel,~     Sirolimus, Everolimus) have been developed. These drugs, generally used in high doses for~     cancer chemotherapy, are released in small doses on the medical angioplasty devices. During~     inflation, the local release of the anticancer (antimitotic) molecule through the different~     layers of the vessel wall (Paclitaxel is lipophilic and hydrophobic) confers local~     antiproliferative action without the systemic toxic effects associated with high-dose~     chemotherapy.~      These medical devices have demonstrated their efficacy in terms of increase in primary and~     secondary patency rates on procedures such as coronary artery angioplasty, femoro-popliteal~     or sub-popliteal artery angioplasty (treatment of angina or lower limb arteriopathy).~      These drug-eluting balloons (DEBs) are also CE marked with the recommendation of being~     indicated for AVF anticancerangioplasties, but no randomised multi-centre clinical trial has~     proven their medical effectiveness, and in particular their contribution in terms of patency~     rate improvement. However, studies on animal models show significant results regarding~     efficacy against neointimal hyperplasia and the first single-centre clinical trials on a~     small sample size appear promising.~      The key assessment criterion is primary patency of the dilated stenosis at one year defined~     by patients efficaciously dialysed at one year without re-intervention on the dilated lesion~     after initial angioplasty. The delay of occurrence of dilation will be considered (censored~     criteria). Patients that will be non-evaluable for the primary endpoint (death, lost to~     follow-up…) will be censored at the date of the latest news.~   "
49934|NCT02913261|"~     To evaluate the safety and efficacy of ruxolitinib compared to Best Available Therapy in~     patients with corticosteroid-refractory acute graft vs. host disease after allogeneic stem~     cell transplantation~   "
49935|NCT02913248|"~     The purpose of the present investigation is to record and compare bacterial compositions in~     subgingival plaque samples and saliva samples in subjects receiving periodontal treatment.~     The hypothesis is that the composition of the salivary microbiota might reflect local~     bacterial alterations in relation to periodontal treatment.~   "
49936|NCT02913235|"~     The purpose of the present investigation is to record and compare bacterial compositions in~     supragingival plaque samples and saliva samples in subjects discontinuing regular oral~     hygiene for 10 days. The hypothesis is that the composition of the salivary microbiota might~     reflect local bacterial alterations in relation to discontinuation of oral hygiene.~   "
49937|NCT02913222|"~     Intra-articular, prearthritic hip disorders (PAHD) result in substantial dysfunction in young~     adults and are proposed precursors to hip osteoarthritis (OA). Effective treatment of PAHD is~     needed to improve function in the young adult and prevent or delay the onset of hip OA,~     however evidence related to treatment of PAHD is limited. This research will provide the~     foundation for a future clinical trial to assess the efficacy of movement pattern training,~     an innovative rehabilitation approach for the treatment of PAHD.~   "
49938|NCT02913209|"~     Fatigue is consistently rated as the top symptomatic complaint for individuals with multiple~     sclerosis (MS). Currently, the MS Fatigue Impact Scale (MFIS), a subsection of the Multiple~     Sclerosis Quality of Life (MSQoL), is the clinical standard used by neurologists for~     monitoring and tracking fatigue in individuals with MS. However, fatigue is multidimensional~     phenomenon and subjective measures have had poor or limited relationships with functional~     status. While previous study has focused on contributing factors to fatigue such as sleep~     disorders and diminished cortical excitability, this line of inquiry has neglected the role~     of muscle structure and function on fatigue in every day functional tasks. An alternative~     approach is to assess quantitative fatigue using anaerobic testing methods. However, more~     knowledge is needed to understand the role that quantitative fatigue plays in self-reported~     fatigue measures and function of daily activities. Our purpose is to determine the~     association between quantitative fatigue tests with performance-based measures of mobility~     and self-reported health-related quality of life. Our secondary goal is to understand how the~     intrinsic properties of muscle tissue influence muscle performance in Veterans with MS.~   "
49939|NCT02913196|"~     This is a multi-center, Phase I study of apalutamide in combination with abiraterone acetate,~     docetaxel and prednisone in patients with metastatic mastrate resistant prostate cancer~     (mCRPC).~      This study is designed to determine the dose that apalutamide can be administered safely in~     combination with abiraterone acetate, docetaxel and prednisone.~   "
49940|NCT02913183|"~     Stroke is one of the main severe disease of public health importance. Recent studies showed~     that old age is one of the most important factors in influencing the outcome of patients with~     acute stroke, and the young plasma can reverse age-related brain impairments in mice.~     Therefore, this pilot study aims to investigate whether young plasma is effective in~     alleviating brain injury and neurologic deficits induced by acute stroke in patients.~   "
49941|NCT02913170|"~     The aim of this study is to examine the effects of nattokinase supplementation on hemostatic~     factors in nondiabetic and hypercholesterolemic subjects. Collagen-epinephrine closure time,~     prothrombin time, activated partial thromboplastin time, fibrinogen levels, and lipid~     profiles were measured at baseline and at 8-week follow-up.~   "
49942|NCT02913157|"~     The purpose of this clinical trial is to determine if HCQ in a dose of 400mg daily can~     prevent worsening of walking ability in people PPMS. The number of participants in this study~     will be 35. A maximum of 42 people with PPMS will be included. The trial is funded through a~     private donation to the Hotchkiss Brain Institute MS Translational Clinical Trials Research~     Program and the University of Calgary. There is no sponsorship from the pharmaceutical~     industry.~   "
49943|NCT02913144|"~     OBJECTIVES: To investigate the incidence of cardiovascular events as well as progression of~     coronary artery calcium (CAC) in healthy middle-aged subjects over a period of 7 years, and~     the relation to traditional as well as new cardiovascular risk factors.~      METHODS: The Danrisk cohort was established in 2009-2010 based on random retrieval from the~     Danish national civil registry (N=1825). Initially, distribution of gender, area of residence~     and year of birth (1949 or 1959) were equal among the 4 involved centres (OUH, Svendborg,~     Vejle and Esbjerg). A total of 1257 subjects (69%) accepted the invitation to undergo~     cardiovascular risk evaluation including non-contrast enhanced cardiac CT-scan for CAC~     estimation, and a total of 1227 subjects were found free of cardiovascular disease (CVD) and~     diabetes (DM), and was included in the study back then.~      In 2014-2015 the DanRisk cohort was invited to a 5 year follow-up examination. The~     investigators examined a total of 1031 subjects (82%) in the investigators 4 regional~     centres. The follow-up examination included general health evaluation and estimation of CAC~     by non-contrast enhanced cardiac CT-scan. Information of death, cardiovascular events and~     medication usage was obtained from the Danish national patient register, the Danish register~     of causes of death and the Danish national database of reimbursed prescriptions in 2016.~   "
49944|NCT02913131|"~     This is a single center prospective imaging study investigating the utility of hyperpolarized~     C-13 pyruvate as a Biomarker of PI3K/mTOR pathway inhibition in patients with advanced solid~     tumor malignancies. The current protocol will serve as a companion imaging biomarker study~     paired with therapeutic trials of PI3K/mTOR pathway inhibitors (e.g. CUDC-907, BYL719), as~     well as a stand-alone protocol for patients treated with standard-of-care therapies~     inhibiting the PI3K/mTOR signaling pathway (eg. everolimus).~   "
49945|NCT02913118|"~     Adjunctive Therapy of AndrographolidSulfonate in Community Acquired Pneumonia: A Multicenter,~     Randomized,Double-blinded, Placebo Controlled Clinical Trial. The hypothesis is that~     combination therapy with Andrographolid Sulfonatein injection and antibacterial is~     significantly better than antibacterial alone in achieving clinical stability among~     hospitalized CAP patients.~   "
49946|NCT02913105|"~     The purpose of the present study is to assess the effects of LMB763 with respect to safety,~     tolerability, and on markers of liver inflammation in patients with NASH~   "
49947|NCT02913092|"~     This study will evaluate the role of using electronic sensors for asthma inhaler devices in~     monitoring medication adherence and asthma control~   "
49948|NCT02913079|"~     Context and Rationale: Uninterrupted sitting is associated with increased risk of diabetes,~     heart disease, and death, even among people who are physically active. These relationships~     are likely due to increases in post-meal blood sugar observed when people sit for long~     periods (e.g. > 1 hour) without interruption. In contrast to sitting, standing results in~     large reductions in post-meal blood sugar levels. Our group has recently shown that sit-stand~     desks result in large (e.g. 2.5 hour/day) reductions in occupational sitting time. Taken~     together, these findings suggest that sit-stand desks may help to reduce post-meal blood~     sugar levels. However, this has yet to be examined in the field. Theoretical Approach and~     Objectives: The objective of this randomized crossover study is to determine whether people~     have lower blood sugar when using a sit-stand desk, in comparison to a desk that can only be~     used while sitting. Methods and Procedures: Sixteen participants will be asked to wear a~     continuous glucose monitor to measure their blood sugar levels during 2 separate conditions.~     During one condition, they will be asked to use a sit-stand desk to sit and/or stand as much~     as they like during 1 workday. During the other condition, they will be asked to work at a~     seated desk for 1 workday. Participants will be provided with identical meals to eat during~     each of the two conditions. We hypothesize that participants will have lower blood sugar~     levels on the day when they use the sit-stand desk, in comparison to the day using a~     traditional seated desk. Significance and Future Use: If our results support this hypothesis,~     this would suggest that sit-stand desks may be a useful way to reduce blood sugar levels in~     people at risk for diabetes. This could also lead to larger population-based interventions~     studying the health impact of sit-stand desks.~   "
49949|NCT02913066|"~     Will meet the inclusion criteria of patients with esophageal squamous cell carcinoma, divided~     into 2 groups randomly:~      Experimental group: radiotherapy combined with S-1 chemotherapy.~      Control group: radiotherapy combined with S-1 chemotherapy and cisplatin.~   "
56895|NCT02822300|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
49950|NCT02913053|"~     Exercise interventions to prevent dementia and delay cognitive decline have gained~     considerable attention in recent years. Human and animal studies have demonstrated that~     regular physical activity targets brain function by increasing cognitive reserve. Although~     initial studies indicate enhanced cognitive performance in patients with mild cognitive~     impairment (MCI) following an exercise intervention, little is known about the effect of an~     extensive, controlled and regular exercise regimen on the neuropathology of patients with~     MCI.~      The aim of this study is to compare a 12- month aerobic exercise programme versus a~     stretching and toning (non-aerobic) programme versus a control group on the progression of~     cognitive decline in MCI.~      It is hypothesized that MCI-related decreases in cognitive and psychomotor functioning will~     show less progression or even be improved after a one-year aerobic exercise intervention~     compared to a group of patients undergoing stretching and toning exercise as well as to a~     control group provided with no intervention.~   "
49951|NCT02913040|"~     In this multi-centre randomized controlled trial the investigators compare the effect on~     dyspnoea severity of oxgen delivery through High Flow Nasal cannula with Low Flow Nasal~     Prongs in children < 2 years of age hospitalised for bronchiolitis with moderate-severe~     dyspnoea.~   "
49952|NCT02913027|"~     The purpose of this study is to investigate patients self-reported comfort levels during each~     section of the pelvic exam.~   "
49953|NCT02913014|"~     This study is being done to find out if patients taking Anti Arrhythmia Drugs (AAD's) after~     cryoballoon ablation for atrial fibrillation, compared to patients who do not take Anti-~     Arrhythmic Drugs after an ablation affect Atrial Fibrillation from coming back. The study~     will also look at the side effects of the AAD's.~   "
49954|NCT02913001|"~     This randomized controlled trial will examine changes in some hormonal markers associated~     with acne among adults with moderate/severe acne randomized to a low glycemic index and~     glycemic load diet or usual eating plan for two weeks.~   "
49955|NCT02912988|"~     In-vitro fertilization (IVF) is the treatment of choice for couples with prolonged~     infertility. The treatment usually involves hormonal stimulation of the ovaries by follicle~     stimulating hormone (FSH), followed by surgical removal of eggs which are then mixed with~     sperm in the laboratory to create embryos. The success rates of IVF treatment remain~     unsatisfactory and are no longer increasing. One of the reasons is an adverse effect of high~     serum estradiol levels following FSH stimulation on the lining of the uterus.~      Letrozole is a drug used in the prevention of recurrence of breast cancer because of its~     action to reduce the intra-ovarian aromatization of androgens to estrogens. It is now~     increasingly used for ovulation induction and is as safe as clomiphene citrate. Use of~     letrozole during standard ovarian stimulation for IVF producing adequate numbers of oocytes~     with physiological levels of estradiol may increase the present success rate of standard IVF~     treatment.~      The aim of this randomized study is to compare the live birth rate of FSH alone versus~     combined FSH and letrozole used for ovarian stimulation in IVF treatment.~   "
49956|NCT02912975|"~     A randomized controlled clinical to examine the effect of mirror therapy on phantom pain and~     residual limb pain in patients with traumatic transtibial amputations in Cambodia. The study~     will be conducted with a semi-crossover design using self-rated pain and function as the main~     result variables.~   "
49957|NCT02912962|"~     Fetal alcohol spectrum disorder (FASD) describes a collection of physical, mental, and~     behavioral disabilities that result from prenatal alcohol exposure (PAE). Individuals with~     FASD often struggle with self-regulation, or the ability to control thoughts, emotions and~     actions, which can lead to many long-term problematic life circumstances.~      This study aims to improve self-regulation abilities in adolescents, aged 11-17, with FASD~     using a targeted intervention. Researchers adapted the Alert Program®, a developed~     intervention targeting self-regulation in children, to be appropriate for an adolescent FASD~     population. Participants are split into two groups: an FASD intervention group, and an FASD~     waitlist group. These groups are compared on a variety of measures. These measures include~     cognitive measures (executive functioning, response conflict, inhibitory control, etc),~     behavioural measures (self-regulation, adaptive behaviour, etc), and physiological measures~     (cortisol and sleep). The FASD intervention group will be tested at baseline and once after~     the intervention, and lastly after an approximately 12-week wait following the intervention.~     The FASD waitlist group will be tested at baseline, after a three month wait period, and~     again after receiving the intervention.~      The investigators expect that the Alert program® will lead to significant improvements in~     participant's self-regulation abilities as evidenced by cognitive, behavioural, and~     physiological changes. Improving self-regulation in adolescents with FASD will reduce the~     high level of adverse outcomes experienced by adolescents with FASD, and help them have a~     successful transition into adulthood.~   "
49958|NCT02912949|"~     This is a Phase I/II, open-label, multi-center, multi-national, dose escalation, single agent~     study to assess the safety, tolerability, PK, PD, immunogenicity and anti-tumor activity of~     MCLA-128~   "
49959|NCT02912936|"~     The purpose of this study is to determine safety, tolerability, and pharmacokinetics/dynamics~     of a ketogenic dietary supplement containing medium chain triglycerides (MCTs) in patients~     with Alzheimer disease (AD). Novel imaging and laboratory biomarkers in response to this~     intervention will also be explored.~   "
49960|NCT02912923|"~     The project targets stroke survivors to investigate the effect of augmented feedback (using~     robotic force cues and visual feedback) and rewards (game scores), on their upper limb~     reaching patterns and trunk compensatory movements~   "
49961|NCT02912910|"~     To study central blood pressure changes caused by commonly used high blood pressure~     medications in pregnancy.~   "
49989|NCT02912546|"~     Postural changes are commonly used as therapeutic maneuver to enhance or reduce cerebral~     perfusion. For instance, in acute stroke, the patient can be positioned in head down tilt~     position so as to increase perfusion of cerebral tissues perfusion. In During stroke and in~     hypertensive patients and during stroke, varying degrees a various loss of cerebral~     autoregulation is loss are usually observed. The aim of this study is to assess cerebral~     perfusion with ASL perfusion in human subjects in different conditions: healthy, hypertensive~     and stroke.~   "
49990|NCT02912533|"~     The purpose of this study is to investigate the safety and efficacy for 52-week dosing of~     JR-131 in renal anemia patients with chronic kidney disease (CKD).~   "
50214|NCT02909569|"~     This study evaluates the effect of twice daily dose of INCB39110 in the treatment of itch in~     adults.~   "
49962|NCT02912897|"~     The etiologic mechanisms involved in multiple sclerosis (MS) are not yet fully understood.~     Indeed MS is a multifactorial disease involving genetic and environmental factors and~     Epstein-Barr-Virus (EBV) could be one of these factors. However the link between EBV~     infection and the immunological mechanisms underlying MS is not clear. Robust~     sero-epidemiological evidences support an association between EBV infection and MS, and~     immunological data suggest an altered/deficient immune response against this virus. In~     healthy individuals EBV produces a persistent infection that is tightly controlled by the~     immune system. In patients with MS, cellular and humoral immune studies demonstrate an~     altered response against the virus with a T-cell abnormal reactivity against the EBV-infected~     autologous B-cells, elevated humoral immune response to Epstein Barr Nuclear Antigen-1, and~     in the case of children, an increased EBV shedding, demonstrating frequent EBV reactivations.~     Thus, it has been proposed, that patients with MS present a partially inefficient control of~     the EBV infection. Some experimental data support the hypothesis suggesting that the presence~     of autoreactive EBV-B cells in the meninges of patients, probably due to an insufficient~     clearance of these cells by the immune system, lead to the infiltration of autoreactive T~     cells. Another hypothesis also suggests a deficient control of the virus, in that case during~     the inactive phase of the disease. Together, the above data and hypotheses lead to the notion~     that an immune intervention capable of restoring the host-EBV balance could be beneficial to~     MS patients In this project, we will assess the feasibility and safety of autologous transfer~     of several amounts of CD8 T cells directed against autologous EBV transformed B cell lines,~     in order to finally restore an efficient control of EBV in MS patients. The main objective of~     the project is to test the feasibility and safety of the process, while efficacy parameters~     will be also assessed in secondary objectives.~   "
49963|NCT02912884|"~     Myeloproliferative neoplasms (MPN) such as Polycythemia Vera (PV) and, Essential~     Thrombocythaemia (ET) are rare clonal myeloid neoplasms associated with an increased risk of~     both venous and arterial thrombosis. Thrombotic complications are the main determinant of~     morbidity and in a less extend mortality.~      Routine haemostasis analysis (TP, aPTT) are usually normal and are useless to demonstrate a~     hypercoagulable state. However, previous evidence suggests that global coagulation tests such~     as thrombin generation or thromboelastometry are able to detect signs of procoagulant~     imbalance in MPN. Similarly, current data seems to demonstrate that fibrin clot properties~     (clot permeability, turbidimetry, clot lysis time) properties is altered suggesting an~     hypercoagulable state.~      Goals of PV and ET treatments are to control blood count to reduce the risk of thrombotic~     events. Moreover, new drugs such as Janus Kinase Inhibitors (JAKi) were recently licensed for~     PV and are under investigations on clinical trial for ET. It is currently unknown if~     treatments that were used for ET and PV, and especially JAKi are able to modify the~     hypercoagulable state that is observed in those diseases, and if there is difference between~     drugs.~      To evaluate impact of MPN treatment on prothrombotic haemostatic profile, we propose to~     evaluate global coagulation and fibrin clot properties in MPN, depending on the treatment.~   "
49964|NCT02912871|"~     Based on published animal and human studies, ExAblate Transcranial subthalamotomy can be as~     safe and as effective as any of the surgical treatments within the currently accepted~     standard of care including radiofrequency lesioning and Deep Brain Stimulation (DBS). A~     unilateral lesion of the subthalamic nucleus has shown reduction of contralateral motor~     symptoms in Parkinson's disease (PD). Using ExAblate Transcranial Magnetic Resonance guided~     High Intensity Focused Ultrasound (MRgHIFU) to create the subthalamotomy has several~     potential advantages over current therapies including the fact that transcranial lesioning~     can be performed in a precise manner with simultaneous as well as continuous clinical and~     radiographic monitoring. If the potential of ExAblate Transcranial subthalamotomy can be~     realized, it could supplant radiofrequency and radiosurgery techniques and provide a viable~     alternative procedure for subjects considering DBS.~   "
49965|NCT02912858|"~     Chronic venous leg ulcers (VLU) are painful, debilitating wounds that place a significant~     burden on the patient, their family, and healthcare resources. Treating VLU can present a~     significant challenge to clinicians, who currently have a limited range of treatments at~     their disposal. The mainstay of treatment is compression bandaging, ambulation and elevation~     at rest. In addition to the aforementioned, intermittent pneumatic compression has also been~     utilised1. When applied to the leg or foot intermittent pneumatic compression (IPC) devices~     intermittently inflate and deflate to increase venous return. These devices can be~     uncomfortable to wear, and compliance can be inhibited because of size, weight and external~     power source that limit the patient's mobility. In patients who cannot walk, or in those who~     are unable to tolerate compression bandaging, ulcers may deteriorate and never heal.~     Accordingly, there is a need for novel, alternative devices or strategies that can be used to~     complement or replace compression bandage therapy.~   "
49966|NCT02912845|"~     The primary purpose of this study is to confirm the safety of KamRAB (Human Rabies~     Immunoglobulin) in children ages 0 months to <17 years, when administered as part of~     post-Rabies Exposure Prophylaxis (PEP).~   "
49967|NCT02912832|"~     The purpose of this study will be to determine the performance characteristics of TBDx with~     culture as a gold standard. In addition, the investigators will assess the laboratory~     technicians' appraisal and technical suitability of the TBDx system.~   "
49968|NCT02912819|"~     General anesthesia and mechanical ventilation promotes atelectasis and airway closure. The~     open-lung approach (OLA) strategy restores the functional residual capacity. Pulse oximetry~     hemoglobin saturation (SpO2) using room air can diagnose shunt induced by lung collapse~     during general anesthesia and the SpO2 breathing air was useful to detect the lung´s opening~     and closing pressure during a recruitment maneuver (RM) in morbidly obese anesthetized~     patients.~      Investigators hypothesized that the SpO2 breathing air can personalize the open-lung~     approach.~   "
49969|NCT02912806|"~     Evolving reimbursement policies are driving health systems to improve quality and efficiency.~     Transitioning to an electronic health record (EHR) provided Dartmouth-Hitchcock Medical~     Center (DHMC) an opportunity to redesign staff roles and care path for Total Knee Replacement~     (TKR). The organization implemented a coordinated team-based care delivery model that~     integrated real-time measurement of: (1) compliance with trusted guidelines, (2) process of~     Shared Decision-Making (SdM), and (3) use of Patient-Reported Outcomes (PROs). The~     investigators present the implementation protocol and data.~   "
49991|NCT02912520|"~     Investigators hypothesize that Immunoglobine (Ig) production is influenced by the microbiota~     of the gut. Investigators will compare microbiota-dependent Ig production in the~     bronchoalveolar lavage fluid of patients with and without antibiotic therapy in order to~     detect significant differences.~   "
49992|NCT02912507|"~     Study to evaluate safety and efficacy of treatment with the investigational Cutera enlighten~     laser for tattoo removal as compared to treatment with the Cynosure PicoSure laser~   "
49993|NCT02912494|"~     The purpose of this study is to investigate the equivalence of JR-131 to Darbepoetin alfa and~     evaluate the safety of JR-131 in renal anemia patients with chronic kidney disease (CKD).~   "
49970|NCT02912793|"~     This research study is being conducted to find out whether Trappsol® Cyclo™, an experimental~     treatment for people with Niemann-Pick disease Type C1 (NPC-1) is safe at 3 different dose~     levels and what effects it has on people who have this condition. NPC-1 is caused by a defect~     in a protein which is important for the transport of fatty substances like cholesterol out of~     cells. Without this protein, fats build up in the cells ultimately leading to organ damage.~     The way in which this experimental treatment works is not fully understood but laboratory~     experiments have shown that it can potentially remove cholesterol build up from the cells in~     people who have NPC-1. Approximately 12 patients will be asked to take part in this research~     study for up to 56 weeks in total. recruitment is expected to take 9 months.Patients who take~     part will receive treatment by an intravenous infusion every two weeks. The study will look~     at what the body does to the drug as well as what the drug does to the body by taking and~     examining blood and urine samples. Samples of Cerebrospinal fluid (CSF) are also taken by~     lumbar puncture during and following the first treatment dose. Patients will also have their~     hearing tested, be asked questions by their doctor as well completing questionnaires to help~     assess any changes in their condition during treatment. Optional assessments patients can~     choose to take part in include liver biopsies, additional lumbar punctures for~     CSF.examinations to see if the drug is affecting these. This study is being sponsored and~     funded by CTD holdings INC. It is planned to be run in the UK, Italy, and Sweden.~   "
49971|NCT02912780|"~     The advancement in life-saving technologies and clinical expertise in the care of extremely~     premature infants, have resulted in the development of large neonatal intensive care units~     (NICU). It has been suggested that reconstruction of megaunits of neonatal intensive care to~     smaller care units with specific patient population and clinical team providers will be~     essential to maintain optimal teamwork, quality of care and patient outcome.~      Despite the growing knowledge around the need for reconstruction of large NICUs to smaller~     units of care, there is no evidence regarding the safety and efficacy of microsystem model of~     care on the key aspects of health care. At the McMaster Children's Hospital (MCH), we planned~     a change from standard model of care to the microsystem model of care and therefore we aimed~     to prospectively assess the effect of this organizational change on the variable aspects of~     health care.~      A working group met weekly to formulate the implementation planning, to review the adaptation~     and adjustment process and to ascertain the quality of implementation following the~     initiation of the microsystem model.~      The study was retrospectively registered.~   "
49972|NCT02912767|"~     The investigators are interested in understanding how the patient has been doing since their~     surgery for endometrial cancer and if they are experiencing any symptoms related to~     lymphedema (swelling) in the your lower body. The investigators hope that information from~     the patient and others will help them improve care for women treated for endometrial cancer.~   "
49973|NCT02912754|"~     This study involves adding the kinase inhibitor Ruxolitinib to Ibrutinib to treat Chronic~     Lymphocytic Leukemia (CLL).~   "
49974|NCT02912741|"~     The aim of this study is to evaluate the addition of new technology of resin modified~     glass-ionomer in comparison to resin infiltration in treating post-orthodontic white spot~     lesions; both applies into the same patient's mouth; to reveal which material will have more~     clinical satisfactory performance inside the oral cavity and to overcome the high expensive~     cost in treating such clinical cases~   "
49975|NCT02912728|"~     The primary objective of this study is to compare the efficacy and safety of CGM alone and~     CGM combined with a family behavioral intervention with a control group using home blood~     glucose monitoring (BGM) alone.~   "
49976|NCT02912715|"~     Prospective, multi-center, non-randomized clinical trial with follow-up investigations at 1,~     6 and 12 months. To confirm safety and efficacy of Passeo-18 Lux DCB in new and non-stented~     re-stenotic lesions in the superficial femoral artery (SFA) and proximal popliteal artery~     (PPA) in a Chinese patient population.~   "
49977|NCT02912702|"~     This study aimed to investigate the efficacy and safety of Pegaspargase together with~     liposomal doxorubicin, etoposide and high dose methylprednisolone (L-DEP) as an initial~     treatment for Epstein Barr virus-induced hemophagocytic lymphohistiocytosis.~   "
49978|NCT02912689|"~     Number of Patients:~      Total no. of patients = 40 patients NIV-PSV group (Group A) = 20 NIV-NAVA group (Group B) =~     20~      Inclusion criteria~      a) Patients of Chronic obstructive pulmonary disease with acute hypercapnic respiratory~     failure (pH < 7.35 and PaCO2 >45 mmHg) requiring noninvasive ventilation and with no~     indication for invasive mechanical ventilation.~      Exclusion criteria~        1. Patient with any contra-indication for insertion of nasogastric tube (like recent~          gastrointestinal bleeding in previous 30 days, esophageal varices)~        2. Patient with any contraindication of noninvasive ventilation (such as hemodynamic~          instability, active gastrointestinal bleed etc)~        3. Patients with a known neuromuscular, central or peripheral nervous system disorder.~        4. Patient not willing to give consent.~      Control(s): Patients receiving pressure support ventilation (NIV-PSV) will act as control~      Study design: Randomized interventional study~      Dosages of drug: None~      Duration of treatment: Till patient improves or requires invasive ventilation.~      Brief Methodology Patients of COPD with acute exacerbation will be randomized into two groups~     (group A and group B) to receive NIV-PSV or NIV-NAVA respectively. A special naso-gastric~     catheter (EAdi-catheter) will be placed in all patients. In each mode, NIV will be applied~     using a non-vented oro-nasal mask that will be fitted enough to avoid air leaks. Patients in~     Group A will receive NIV-PS and Group B will receive ventilation via NIV-NAVA. Pressure~     support and PEEP levels will be set by the treating physician to achieve a tidal volume (Vt)~     of 6 to 8 mL/kg of ideal body weight. NAVA level will be adjusted to match peak pressures of~     NIV-PSV using manufacturer-supplied software. After stabilization, a 30-min period of each~     NIV trial will be recorded and manually analyzed offline. Subsequent readings will be taken~     at 2, 6 and at 24 hours and then at 6 hourly interval from day 2 onwards. In each trial,~     patient-ventilator asynchronies (ineffective efforts, auto triggering, premature cycling,~     delayed cycling, and double triggering) will be determined on EAdi, airway pressure, and flow~     signal. The number of each type of asynchrony, defined as the number of events per minute,~     will be determined for each recording period. The asynchrony index (AI), in percentage, will~     be calculated as described previously, and an AI >10% will be considered severe asynchrony.~     Patient comfort level after each mode of ventilation will be assessed by using visual~     analogue scale. Various clinical, ventilatory and arterial blood gas parameters will be~     recorded.~      Statistical analysis Data will be expressed as mean ± standard deviation (SD), or percentage.~     Differences in continuous variables between the two groups will be compared using student's t~     test (or Mann-Whitney U test); while differences in categorical data will be compared using~     the chi- square test (or Fisher's exact test). A p value of less than 0.05 will be considered~     statistically significant.~   "
49979|NCT02912676|"~     Acute Lymphoblastic Leukaemia (ALL) is the most frequent cancer in children. The survival~     rate has improved significantly during the last decades, but the treatment still fails to~     cure 15 % of the patients. Within the Nordic/Baltic countries, children are treated according~     to the same protocol, i.e. NOPHO ALL-2008 protocol. Children and adolescents with~     Lymphoblastic Non-Hodgkin's Lymphoma (LBL) are treated in accordance with the EURO-LB 02~     protocol, whereas adults with Lymphoblastic Non-Hodgkin's Lymphoma in Denmark are commonly~     treated in accordance with the NOPHO ALL-2008 protocol.~      The longest treatment phase in both protocols is maintenance therapy, which is composed of~     6-Mercaptopurine (6MP) and Methotrexate (MTX).~      The cytotoxic property of 6MP relies upon conversion of 6MP into thioguanine nucleotides~     (TGN), which can be incorporated into DNA instead of guanine or adenine. This incorporation~     can cause nuclotide mismatching and cause cell death second to repetitive activation of the~     mismatch repair system. At Rigshospitalet investigators have developed pharmacological~     methods able to measure the incorporation of TGN into DNA (DNA-TGN). In a Nordic/Baltic study~     the investigators have demonstrated higher levels of DNA-TGN during maintenance therapy in~     children with ALL that do not develop relapse.~      Preliminary studies indicate that the best approach to obtain DNA-TGN within a target range~     could be a combination of 6MP, MTX and 6-thioguanine (6TG), as 6TG more readily can be~     converted into TGN.~      This study aims to explore if individual dose titration of 6TG added to 6MP/MTX therapy can~     achieve DNA-TGN levels above a set target above 500 fmol/µg DNA, and thus can be integrated~     into future ALL and LBL treatment strategies to reduce relapse rates in ALL and LBL.~      The investigators plan to include 30 patients, and A) give incremental doses of 6TG until a~     mean DNA-TGN level above 500 fmol/µg DNA is obtained; and B) analyze the changes in DNA-TGN~     as well as cytosol levels of TGN, methylated 6MP metabolites, and MTX polyglutamates (the~     latter two metabolites inhibit purine de novo synthesis and thus enhance DNA-TGN~     incorporation), and C) occurrence of bone-marrow and liver toxicities during 6TG/6MP/MTX~     therapy.~   "
49980|NCT02912663|"~     This is a phase 1, blinded-outcome, randomized, placebo controlled study to investigate the~     safety and feasibility of super-selective intra-arterial administration of verapamil and~     magnesium sulfate immediately following successful endovascular thrombectomy as a potential~     neuroprotective synergistic therapeutic strategy in emergent large vessel occlusion stroke.~     This trial represents the first time that magnesium sulfate will be evaluated in human~     subjects as a superselectively administered neuroprotective agent administered in an acute~     time frame as an adjunct to intra-arterial thrombectomy. Furthermore, it will represent the~     first trial to evaluate combinational therapy for acute stroke neuroprotection.~   "
50215|NCT02909556|"~     Cinical trial aimed at evaluating the safety and performance of the ACURATE neo™ AS Aortic~     Bioprosthesis and ACURATE neo™ AS TF Transfemoral Delivery System for CE mark approval~     purposes.~   "
49981|NCT02912650|"~     This is a randomized, double blind, placebo-controlled, parallel group, single-center study~     in approximately 560 subjects to determine the overall analgesic efficacy and safety of a~     fixed-dose ibuprofen 250 mg / acetaminophen 500 mg formulation compared to ibuprofen 250 mg~     alone, acetaminophen 650 mg alone, and to placebo. Subjects will be healthy males and females~     aged 18-40 years, inclusive, who are experiencing post-operative pain following surgical~     extraction of 3 or more third molar teeth. Following extraction, subjects must experience,~     within 5 hours, post-surgical pain of at least moderate severity (on a 4-point categorical~     scale), confirmed by a Visual Analog Pain Severity Rating Scale (VAS PSR) of at least 50 mm~     on a 100 mm VAS PSR scale. Eligible subjects will be randomized to receive a single oral dose~     of study medication under double-blind conditions and then evaluated on site for 12 hours~     following administration of study medication. Subjects will provide self-ratings of pain~     severity and pain relief at various time points using categorical and numerical scales.~     Additionally, subjects will also evaluate the time to first perceptible relief and time to~     meaningful relief using a double stopwatch method. Finally, at 12 hours, subjects will~     complete a categorical Global Evaluation of the study medication. A review of any reported~     adverse events will also be completed.~   "
49982|NCT02912637|"~     Chronic lung diseases show a gradual onset of irreversible lung damage which can lead to~     severe breathing problems and/or respiratory failure. Imaging is central to guiding~     treatment; however, current techniques are either inaccurate or involve exposure to~     radiation. Recent developments in lung magnetic resonance imaging (MRI) provide promise as a~     radiation-free alternative. However, conventional MRI cannot directly show changes in~     distribution of inhaled air or absorption of gas which are important signs of early lung~     disease. Recently MRI imaging of the inhaled gas contrast agent Xenon has been developed~     which can provide this important information. This study aims to determine how Xenon MRI can~     help determine air flow distribution and gas uptake in the lungs. The investigators will also~     be able to compare the information from patients with that from healthy volunteers. This~     should give insight into the processes involved in chronic lung diseases and help evaluate~     disease extent in patients.~   "
49983|NCT02912624|"~     Circulatory shock is a condition of generalized inadequate blood flow through the body,~     leading to insufficient tissue perfusion and inadequate delivery of oxygen and other~     nutrients, to the extent that tissues are damaged. Four basic mechanisms of circulatory~     failure are distinguished, caused by a scale of underlying illnesses: distributive,~     hypovolemic, obstructive and cardiogenic shock. The last three types are characterized by a~     low cardiac output and hypovolemia. Distributive shock is characterized by peripheral~     circulation failure, with a low systemic vascular resistance, a disturbed microcirculation~     and a high cardiac output. Frequently, these forms overlap.~      Shock is a common problem in the intensive care unit (ICU) as it affects about one third of~     the patients. Septic shock appears to be the most common type, followed by cardiogenic and~     hypovolemic shock. The diagnosis of shock is based on clinical examination with use of~     well-known circulatory parameters such as blood pressure and heart rate; biochemical~     parameters such as lactate and direct (semi-)invasive measurement of cardiac output and other~     variables.~      Since cardiac output is an important determinant of oxygen delivery, many different methods~     of measuring cardiac output have been suggested. These methods range from non-invasive to~     invasive measurements with central lining. The most invasive method, the pulmonary artery~     catheter (PAC) has long been considered the optimal form of monitoring cardiac output by~     using thermodilution. However, this technique is associated with adverse events, such as~     bleeding, and there is no clear evidence of improved outcome. Therefore, numerous other~     techniques have been proposed, ranging from systems that use the dilution technique but only~     require central venous and peripheral artery lines; to less invasive tools that estimate~     cardiac output based on the arterial pressure waveform; and to non-invasive echocardiography.~      Despite technical advances, much remains unknown about the value of conventionally used~     hemodynamic parameters for estimating cardiac output. A distinction between macro- and~     microcirculatory parameters can be made. Commonly used macro-circulatory parameters are heart~     rate, systolic and diastolic blood pressure, mean arterial pressure and central venous~     pressure. Lactate is used as a proxy for microcirculatory status. Over the years several~     other measurements have been suggested to improve insight in the hemodynamics of a certain~     patient or a group of patients. Skin temperature, capillary refill, mottling score and~     urinary output are used for hemodynamic assessment of the peripheral circulation and tissue~     perfusion. Most of these parameters have not been evaluated in a large prospective study and~     especially a combination of all these parameters has not directly been correlated to cardiac~     output.~      More knowledge on the predictive value of all hemodynamic parameters in estimating cardiac~     output could assist physicians in earlier detection of impaired hemodynamics without the need~     for invasive or advanced methods. In this study the investigators aim to evaluate all~     hemodynamic parameters in a large unselected population of critically ill patients and to~     correlate them to cardiac output.~      Purpose:~      The purpose of this study is to create an infrastructure for a registry flexible to~     incorporate temporarily added specific research questions on the outcome of critically ill~     patients.~   "
49984|NCT02912611|"~     This feasibility study will be conducted at 4 international sites located in Asia (Dhahran,~     Nepal); Africa (Blantyre, Malawi and Kilimanjaro, Tanzania) and Latin America (Cochabamba,~     Bolivia).~      Each site comprises a cluster (including 3-4 health centers - 1 district hospital - 1~     regional referral hospital) that service the population around the site area. Patients~     presenting at a health care clinic or hospital emergency department with signs and symptoms~     associated with high and moderate risk of developing AKI will undergo a point of care (POC)~     test to measure serum creatinine, saliva urea nitrogen dipstick (exclusively in Malawi), and~     a urine dipstick test for color, protein, glucose, blood and specific gravity. Patients who~     meet the study inclusion criteria will be approached for consent. Patients enrolled in the~     study will be followed throughout the health care evaluation and tracked through their course~     by location i.e. health care center, hospital, and home. Outcomes will be recorded through 6~     months following the health care evaluation.~      The protocol will have an initial observation phase, during which relevant healthcare staff~     and the research team will be trained to identify patients at moderate or high risk of AKI~     and use of the point of care (POC) test for serum creatinine, saliva urea nitrogen dipstick~     (exclusively in Malawi), and urine dipstick test. During this phase patients will be tracked~     throughout the health care evaluation, however the teleconsultation will not be implemented~     and no specific guidance for managing the patient will be provided.~      During the subsequent intervention phase, the research team will interact with the local~     healthcare providers to and the teleconsultation physician, providing guidance on the~     management of the patient based on a standardized protocol. Protocols for patient care will~     be pre-specified, with minor adjustments to meet local requirements.~   "
49985|NCT02912598|"~     Surgery involving the chest cavity, particularly VATS procedures, often require one-lung~     ventilation. The double-lumen tube (DLT) is considered the gold standard for lung isolation~     with different models of bronchial blockers (BB) used in special populations and~     circumstances. Their routine use is impeded by prolonged placement times, frequent~     malpositionings and higher costs when compared to the DLT, as recently reported in a~     meta-analysis by Clayton-Smith et al. The VivaSight™ SL+EB as a combination of a single-lumen~     tube with an integrated camera and a bronchial blocker allows for endobronchial placement~     without the use of a fiberoptic bronchoscope. An external monitor provides continuous~     visualization of the tracheal carina and the position of the bronchial cuff. The purpose of~     this study was to evaluate the clinical performance of the VivaSight™ SL+EB when compared to~     a left-sided double-lumen tube and established bronchial blockers. The investigators~     hypothesized a reduction in time to initial lung isolation due to the simplified placement~     procedure compared to other bronchial blockers. Continuous intraprocedural airway~     visualization may allow for early detection of dislocations. Necessary repositionings may be~     possible without additional bronchoscopies, reducing both disruptions of ventilation and~     maintenance costs.~   "
49986|NCT02912585|"~     Infections are the main causes of morbidity and mortality in very low birth weight infants.~     Use of mother's own breast milk in feeding these babies is associated with a decreased risk~     of acquiring nosocomial infection. This protective effect is assigned to a plurality of~     immune components in human milk. However, clinical instability of the preterm newborn in the~     first days of life results in delayed initiation of enteral nutrition. Thus, alternative~     methods for colostrum administration have been investigated, such as oropharyngeal~     administration with evidence that would be safe and feasible to perform in children admitted~     to the NICU in the first hours of life. Objective: To evaluate the immune stimulatory effect~     of oropharyngeal administration of colostrum in the incidence of sepsis in very low birth~     weight preterm infants.~   "
49987|NCT02912572|"~     This research study is evaluating a drug called Avelumab as a possible treatment for~     recurrent or Metastatic Endometrial Cancer.~   "
49988|NCT02912559|"~     This randomized phase III trial studies combination chemotherapy and atezolizumab to see how~     well it works compared with combination chemotherapy alone in treating patients with stage~     III colon cancer and deficient deoxyribonucleic acid (DNA) mismatch repair. Drugs used in~     combination chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as~     atezolizumab, may interfere with the ability of tumor cells to grow and spread. Giving~     combination chemotherapy with atezolizumab may work better than combination chemotherapy~     alone in treating patients with colon cancer.~   "
50226|NCT02909413|"~     This study compares desflurane with sevoflurane for school-age children in postoperative~     cognitive function.~   "
50461|NCT02906345|"~     Therapeutic plasma exchange (TPE) should used for patients with septic shock in a controlled,~     prospective study focusing on the organ functions of the patients.~   "
49994|NCT02912481|"~     Arterial catheterization in small children is challenging, even for experienced~     anesthesiologists. For successful arterial catheterization, the arterial diameter,~     cross-sectional area, and depth from the skin surface are important considerations,~     especially in pediatric patients. THe investigators examined the posterior tibial artery~     (PTA) and dorsalis pedis artery (DPA) using ultrasound (US) to find a reasonable alternative~     arterial cannulation site to the radial artery (RA) in pediatric patients.~   "
49995|NCT02912468|"~     Primary Objective:~      To evaluate the efficacy of dupilumab compared to placebo on a background of mometasone~     furoate nasal spray (MFNS) in reducing nasal congestion/obstruction (NC) severity and~     endoscopic nasal polyp score (NPS) in patients with bilateral nasal polyposis (NP). In~     addition for Japan, reduction in computed tomography (CT) scan opacification of the sinuses~     will be also a coprimary objective.~      Secondary Objectives:~        -  To evaluate the efficacy of dupilumab in improving total symptoms score (TSS).~        -  To evaluate the efficacy of dupilumab in improving sense of smell.~        -  To evaluate the efficacy of dupilumab in reducing CT scan opacification of the sinuses~          (primary objective for Japan).~        -  To evaluate ability of dupilumab in reducing proportion of patients requiring treatment~          with systemic corticosteroids or NP surgery.~        -  To evaluate the effect of dupilumab on patient reported outcomes and health related~          quality of life outcome by sinonasal outcome test-22 (SNOT-22).~        -  To evaluate the effect of dupilumab in the subgroups of patients with prior surgery and~          co-morbid asthma (including non-steroid antiinflammatory drug [NSAID] exacerbated~          respiratory disease [NERD]).~        -  To evaluate residual effect in follow up.~        -  To evaluate the safety of dupilumab in patients with bilateral NP.~        -  To evaluate functional dupilumab concentrations (systemic exposure) and incidence of~          treatment-emergent anti-drug antibodies.~   "
49996|NCT02912455|"~     This is a prospective, randomized clinical trial for patients with recurrent type 2 diabetes~     post-gastric bypass surgery that will compare a 6 month course of canagliflozin monotherapy~     vs. placebo on clinical outcomes of type 2 diabetes.~   "
49997|NCT02912442|"~     The present Ph.D.-study investigates the mechanisms behind the association between thyroid~     autoimmunity and reproductive failure.~   "
49998|NCT02912429|"~     There is currently no sufficient evidence if there is superiority of one of the two available~     types (onlay type, inlay type) of patellofemoral arthroplasty. Therefore, it is the aim of~     this study to compare the two types in a prospective comparative setting. Patients on the~     waiting list for patellofemoral arthroplasty are randomized to either onlay or inlay type~     patellofemoral arthroplasty. The KOOS - knee score serves as the primary outcome parameter.~     Secondary outcome parameters are the Marx Activity Scale, the HSS patella score, the Kujala~     Score, radiographic loosening, progression of tibiofemoral degeneration, revision surgery and~     parameters of patellofemoral tracking. Inferential statistics will be performed at 1-year~     follow up data-sets.~   "
49999|NCT02912416|"~     Determine the effect of probiotics on improving iron status in a population of healthy,~     pregnant women.~   "
50000|NCT02912403|"~     Investigators plan to study blood pressure trends on days 3 to 6 of the postpartum period.~     Investigators will use a home blood pressure monitor that stays on the arm, and takes blood~     pressures hourly. Participants will record any symptoms that they feel are attributed to high~     blood pressure and pain medication use.~   "
50001|NCT02912390|"~     Through cervical length measurement in uncomplicated twin gestations, women with cervical~     length ≤ 25 mm will be approached for randomization to cerclage placement or expectant~     management with activity restriction and treatment of preterm labor~   "
50002|NCT02912377|"~     Multiple-doses, randomised, double-blind, three-periods, two-sequences crossover study to~     assess the immunogenicity and pharmacodynamic comparability of a biosimilar pegfilgrastim~     (B12019) and the reference product Neulasta® in healthy subjects~   "
50003|NCT02912364|"~     Double-blind, randomized, two period crossover comparison of the cognitive and behavioral~     effects of Eslicarbazepine acetate and Carbamazepine in healthy volunteers.~   "
50004|NCT02912351|"~     This is a retrospective, single-site observational study, designed to assess the clinical~     outcomes and collect safety data of GMK Revision knee system used for primary or revision~     total knee arthroplasty at minimum two years post-treatment.~   "
50005|NCT02912338|"~     Purpose: To understand the change in body composition, physical functions and quality of life~     of elderly residents with sarcopenic obesity in LTC facilities after the implementation of~     exercise intervention.~   "
50006|NCT02912325|"~     The primary objective is to evaluate the efficacy of FaseMETS for 6 consecutive months in~     lowering serum lipids and glucose in subjects with Metabolic Syndrome;~      The secondary objectives of the trial are:~        -  to evaluate the potential benefit after 3 months of therapy (by an interim analysis)~        -  to evaluate the safety of FaseMETS~   "
50007|NCT02912312|"~     The goal of this clinical research study is to compare how often arm swelling develops after~     4 weeks of radiation treatment to how often arm swelling develops after 6 weeks of radiation~     treatment in patients who receive radiation therapy delivered to the lymph nodes near the~     breast. Researchers also want to know about other side effects that can develop during or~     after radiation treatment.~   "
50008|NCT02912299|"~     This study investigates the differens in sodium storage in skin between normal subjects,~     patients after cardiac surgery and septic patients.~   "
50009|NCT02912286|"~     The aim of this study is to compare the postoperative pain after root canal treatment~     following irrigation by endodontic needle, sonic and passive ultrasonic irrigation~     techniques.~   "
50010|NCT02912273|"~     To establish the optimal strategy of fall-risk assessment to predict falls in older adults~     receiving cancer therapy.~   "
50011|NCT02912260|"~     The primary objective of this study is to determine the effect of once-daily oral MGL-3196 on~     the percent change in hepatic fat fraction from baseline in patients with biopsy-proven~     Non-alcoholic Steatohepatitis (NASH).~   "
50012|NCT02912247|"~     This clinical study is a phase 1 study which carried out to establish the pharmacokinetic~     equivalence and equal safety of human recombinant anti-tumor necrosis factor alpha monoclonal~     antibody injection and Adalimumab when used as a single subcutaneous injection in healthy~     volunteers.~   "
50013|NCT02912234|"~     This study is to evaluate the effects of multiple-dose clarithromycin on the single-dose~     pharmacokinetics (PK) of apixaban with parameters like Cmax, AUC(INF), and AUC(0-T).~   "
50014|NCT02912221|"~     This study will examine the benefits of a monitored physical activity program for~     participants with rheumatoid arthritis (RA) or psoriatic arthritis (PsA) using a wearable~     activity device (e.g.fitbit). The goals of this pilot study are to examine 1) whether an~     incentive is better than no incentive in maintaining an increased level of physical activity~     and 2) the benefits of physical activity on patient reported disease activity in inflammatory~     arthritis.~   "
50015|NCT02912208|"~     Myelodysplastic syndromes (MDS) prevail in older age and are characterized by ineffective~     erythropoiesis and peripheral cytopenias. Supportive therapy is the main therapeutic option~     for most patients. Quality of Life (QoL) is mainly deteriorated by anemia and by the~     limitations associated with thrombocytopenia, neutropenia and transfusion dependence. The~     only available treatment for severe thrombocytopenia, in the presence of bleeding, is~     platelet transfusion.~      Eltrombopag is an orally bioavailable agonist of the thrombopoietin receptor. In adult~     patients with chronic immune thrombocytopenia (ITP), Eltrombopag rapidly increases platelet~     counts and significantly reduces bleeding episodes during treatment. Eltrombopag is well~     tolerated. In 2007, Eltrombopag has received the Orphan Drug Designation for the treatment of~     ITP (EMEA/OD/031/07), and in 2008 the Food and Drug Association approved Eltrombopag for the~     treatment of ITP refractory or resistant. It has been shown that in patients affected by MDS~     and by acute myeloid leukemia, Eltrombopag neither increases the proliferation, nor the~     clonogenic growth capacity of bone marrow blasts. Furthermore, Eltrombopag induces an~     increase in the megakaryocytic differentiation and in the formation of normal megakaryocytic~     colonies. These results provide the rationale for pursuing further research on Eltrombopag~     for the treatment of thrombocytopenia in case of MDS.~      The study is open to adult patients with myelodysplastic syndrome (MDS) with thrombocytopenia~     and low- or intermediate-1 IPSS risk (Index Prognostic Score System).~      Severe thrombocytopenia associated with MDS may lead to death from hemorrhage, even in low~     prognostic risk patients. The benefit of platelet transfusion is short-termed. Patients~     become refractory in the long term. The availability of a treatment that induces the increase~     of platelet count is extremely important, either in terms of quality of life, and in overall~     survival.~   "
50016|NCT02912195|"~     Objective: Evaluate the analgesic efficacy of intravenous (IV) lidocaine versus provider~     chosen dose of IV morphine for the treatment of severe pain in the emergency department.~      Study design: Open-label, randomized controlled pilot study.~   "
50017|NCT02912182|"~     Randomized placebo controlled trial on patients suffering from acute unilateral~     vestibulopathy. Patients will be randomized into 3 arms; 1) Placebo only, 2) Short~     corticosteroid treatment (3days) 3) Longer corticosteroid treatment (11 days).~      Vestibular function as well as subjective symptoms will be estimated in the acute stage and~     regularly up to one year after the debut.~   "
50018|NCT02912169|"~     The intent of this clinical study is to answer the questions: 1) Is the proposed treatment~     safe and 2) Is treatment effective in improving the disease pathology of patients with~     Alzheimer's Disease and clinical outcomes?~   "
50019|NCT02912156|"~     A Randomized, Parallel, Single-Dose Study to Evaluate the Pharmacokinetics of Two Different~     Formulation of Voriconazole 200 mg Tablets in Healthy Adult Subjects.~   "
50020|NCT02912143|"~     The German Pediatric Hemophilia Research Database will collect data on the prophylactic and~     therapeutic use of factor concentrates, complications, outcome measures (joint scores, QoL)~     and living circumstances in newly diagnosed children with hemophilia.~   "
50021|NCT02912130|"~     This project will investigate the synergistic effects of Aerobic and Resistance type~     Exercise, in combination with Protein Supplementation, on; Body Composition, Musculoskeletal~     Functioning, Nutritional Status and Quality of Life in Age-related Sarcopenia.~   "
50022|NCT02912117|"~     Prospective, observational study at Stanford University Hospital comparing the Karius~     Infectious Disease Diagnostic Sequencing Assay to the Final Microbiologic Diagnosis in~     Patients with Fever and Neutropenia.~   "
50023|NCT02912104|"~     This project will clarify the safety and effectiveness of human amniotic epithelial cells~     transplantation for the treatment of primary ovarian insufficiency(POI) patients and provide~     a new therapeutic method for patients with infertility.~   "
50024|NCT02912078|"~     This study will examine recent claims regarding the beneficial effect of warming epidural~     medications in order to hasten the onset of labor analgesia.~   "
50025|NCT02912065|"~     A retrospective chart review to assess feeding tolerance in children who had been switched~     from an intact protein formula to a Peptide based formula due to feeding intolerance in a~     pediatric facility for the developmentally delayed.~   "
50026|NCT02912052|"~     A prospective Randomized Clinical Trial to investigate the Effect ofPeri-operative~     Chemotherapy VS Postoperative Chemotherapy for the Treatment of Colon Cancer With Resectable~     Liver Metastasis~   "
50027|NCT02912039|"~     There is an urgent need for an easy-to-use and accurate quantitative neuromuscular monitor in~     the clinical setting. The aim of this clinical investigation is to examine a prototype of a~     quantitative monitoring instrument that will meet most, if not all, of the clinical~     requirements.~   "
50028|NCT02912026|"~     Open label radiolabelled metabolism study of intravenous and oral solution forms of F901318.~     Five healthy male subjects will receive IV and five will receive an oral solution. Blood,~     urine and faeces will be collected over a period adequate to obtain 90% recovery of parent~     compound and to determine the metabolic profile of both IV and oral forms.~   "
50029|NCT02912013|"~     The Mē Mini is a compact version of the Mē device that was cleared by the FDA for removal of~     unwanted hair and for permanent hair reduction for all skin colors (Fitzpatrick skin~     photo-types I-VI) based on a series of multi-site clinical studies.~      The purpose of this post-marketing study is to support the claims for removal of unwanted~     hair and for permanent hair reduction in the compact version of the device.~   "
50030|NCT02912000|"~     The proposed study is a pre- /post-implementation study in a pediatric practice with a~     control practice designed to test the feasibility and effectiveness of an electronic~     screening and service delivery tool for three modifiable health risk factors in pediatrics:~     parental tobacco use, sugar-sweetened beverages consumption, and poor dental care~   "
50052|NCT02911714|"~     Contrast-enhanced ultrasound (CEUS) is a promising non-invasive imaging tool that may aid in~     the early detection of kidney transplant complications, such as delayed graft function (DGF)~     and acute allograft rejection. The technique uses an intravenous contrast agent to improve~     organ visualization with standard duplex ultrasound equipment. A number of FDA-approved~     agents, including Optison, Definity and Lumason are widely used to improve visualization in~     technically limited echocardiograms, and Lumason was recently approved for contrast-enhanced~     ultrasound of the liver. The specific aims of this study are to: develop, implement and~     refine a contrast-enhanced ultrasound protocol using Lumason to safely maximize kidney~     allograft visualization; determine associations between contrast-enhanced ultrasound and~     patterns of allograft injury consistent with delayed graft function; and to compare~     contrast-enhanced ultrasound with duplex ultrasound for differentiating acute rejection from~     other causes of dysfunction.~   "
50031|NCT02911987|"~     Low back pain is a common disorder, occurring worldwide in both males and females in all age~     groups. The prevalence is higher in females and the incidence peaks between 30 and 65 years.~     It is currently the most frequent musculoskeletal cause of functional disability and it has a~     major socio-economic impact on today's society. Although a small percentage of persons with~     low back pain can be diagnosed with a specific underlying cause, almost 90% of persons with~     low back pain present with symptoms of nonspecific origin. A part of these symptoms are only~     of short duration, but 23% of all people will develop nonspecific chronic low back pain~     (NSCLBP).~      Exercise therapy (ET) is currently an important component in the treatment of NSCLBP.~     Previous studies analysed the effects of various modes of exercise therapy, such as motor~     control therapy, core stability training and aerobic conditioning training. However, therapy~     outcomes can be low, and guidelines in favour of using a specific program are contradictory.~     It thus still remains unclear which therapy modality is best suited. Furthermore, no~     recommendations are available about optimal training intensities during rehabilitation of~     persons with NSCLBP.~      Since as well aerobic as muscular deconditioning are apparent in persons with chronic low~     back pain and improvements in overall physical fitness can affect therapy outcomes in this~     population, ET specifically focussing on physical fitness can be advocated for NSCLBP~     rehabilitation. High Intensity Training (HIT), has been promoted as an effective and~     efficient training method for improving physical fitness and health related parameters in~     healthy persons. Also, HIT resulted in successful reconditioning and improvement of~     functional and disease related outcomes in persons with other chronic diseases such as~     multiple sclerosis, heart failure, COPD and cardiometabolic diseases. Although some studies~     showed promising results for the effect of HIT on low back pain such as high intensity~     isolated, evidence is still scarce and study results are unclear because of methodological~     shortcomings.~      The aim of this randomized clinical trial study is to evaluate the effects of a HIT program~     on disease related outcomes, physical fitness and muscle contractile characteristics compared~     to a conventional rehabilitation program in persons with NSCLBP.~   "
50032|NCT02911974|"~     This is a randomized prospective clinical study comparing a fine needle biopsy device and an~     aspiration needle.~   "
50033|NCT02911961|"~     The objective of this study is to provide preliminary data to describe serum~     acetaminophen-cysteine protein adduct (APAP-CYS) concentrations following therapeutic doses~     of acetaminophen in the setting of non-acetaminophen induced liver injury. This study will~     utilize hepatic embolization as a model of hepatic injury.~   "
50034|NCT02911948|"~     Comparing the efficacy and safety of insulin degludec/liraglutide and insulin degludec both~     in combination with metformin in Japanese subjects with type 2 diabetes mellitus inadequately~     controlled with basal or pre-mix/combination insulin therapy and oral anti-diabetic drugs~   "
50035|NCT02911935|"~     The main objective of the APW-RSV II clinical trial is to evaluate if the addition of~     azithromycin to routine bronchiolitis care, among infants hospitalized with RSV~     bronchiolitis, reduces the occurrence of recurrent wheeze during the preschool years.~   "
50036|NCT02911922|"~     Patients with low-risk or favorable intermediate-risk prostate cancer as defined by 1.2016~     NCCN criteria will be eligible to participate on this study.~   "
50037|NCT02911909|"~     The aim of this study is to determine if there is a difference in post operative~     rehabilitation after anterior cruciate ligament (ACL) reconstruction surgery while using~     moderated blood flow therapy vs. standard physical therapy. All patients undergoing ACL~     reconstruction, between the ages of 18-30, that consent to taking part in the study, and meet~     eligibility criteria, will be included in the study. Patients will be followed for two years~     to determine any differences in muscle strength, thigh circumference, knee range of motion,~     pain, functional and activity levels, patient satisfaction, levels of Human growth hormone~     HGH), Insulin-like Growth Factor (IGF), and Creatine Kinase (CK), KT2000, and Lachman~     physical examination.~   "
50038|NCT02911896|"~     Impairment in physical function is a significant problem for survivors of critical illness.~     There is a growing urgency to develop a core set of outcome measures, which can be adopted in~     clinical and research practice to evaluate efficacy in response to interventions such as~     rehabilitation.~      Phase 1: Development of a new outcome measure. This study aims to examine the development of~     a single outcome measure which may be able to be utilised across the continuum of recovery of~     critical illness in the evaluation of physical function. The study will involve examination~     of two common physical function measures - the Physical Function in intensive care test~     scored (PFIT-s) and De Morton Mobility Index (DEMMI) and the development of a new measure~     based on rasch principles which may be able to capture physical functioning changes in~     individuals with critical illness. Aims: (1) To determine the clinical utility of two~     physical function measures (DEMMI and PFIT-s) when used in isolation across the hospital~     admission; and (2) To transform the (15-item) DEMMI and (4-item) PFIT-s into a single measure~     to evaluate function in intensive care survivors using Rasch analytical principles.~      Phase 2: Measurement properties of the PACIFIC physical function outcome measure in an~     independent validation sample.~   "
50039|NCT02911883|"~     The purpose of this study is to assess the repeatability and reproducibility of measurements~     of the vascular structures and the anatomical structures of the posterior pole of the eye~     based on AngioVue volume scans in normal subjects, glaucoma patients, and retina patients.~   "
50040|NCT02911870|"~     This trial is conducted in Europe. The aim of this trial is to evaluate the effect of SNAC on~     cardiac repolarisation in healthy male subjects~   "
50041|NCT02911857|"~     The primary objective of this study is to evaluate safety and tolerability of ACZ885 in this~     extension study. This extension study offers the opportunity for patients who completed Epoch~     4 of the preceding CACZ885N2301 study to continue to be treated with ACZ885 until approval in~     Japan of the drug in Periodic Fever Syndromes or until development of ACZ885 in Periodic~     Fever Syndromes is suspended.~   "
50042|NCT02911844|"~     The main purpose of this clinical trial is to examine the feasibility and effects of~     fulvestrant in post-menopausal women with pulmonary arterial hypertension (PAH). The study~     will evaluate how well the drug is tolerated. The study will evaluate changes in circulating~     hematopoietic progenitor cells, plasma hormone levels, NT-proBNP, and other plasma biomarkers~     after the administration of fulvestrant. Changes in tricuspid annular plane systolic~     excursion, stroke volume index, right ventricular fractional area change, and other echo~     parameters after fulvestrant administration will be evaluated as well as changes in distance~     walked in six minutes.~   "
50043|NCT02911831|"~     The objective of this study is to determine the effect of 1g of IV tranexamic acid given~     within 1 hour pre-operatively on intraoperative blood loss at time of hysterectomy.~   "
50064|NCT02911558|"~     The aim of the study is to estimate the impact of the implication of a Mobile Team of~     Palliative Care (EMSP) on the palliative strategy in the units with concerned patients. The~     Mobile Team of Palliative of Foch hospital Care was created in March, 2011.~   "
50301|NCT02908438|"~     The study was designed to investigate the effect of luteal-phase administration of~     gonadotrophin releasing hormone agonist(GnRHa) on pregnancy outcomes in in-vitro~     fertilization-embryo transfer.~   "
50044|NCT02911818|"~     This is a 52 week, single center, open-labeled, randomized controlled trial.~      A total of 150 subjects with obesity, who are free of types 1 and 2 diabetes, as well as~     contraindications to weight loss, will be randomly assigned to one of three treatment groups:~     1) lifestyle counseling, as currently recommended by the Centers for Medicare and Medicaid~     Services (CMS) (i.e., CMS-Alone); 2) CMS lifestyle counseling plus liraglutide (i.e.,~     CMS-Liraglutide); or 3) CMS-Liraglutide plus a portion-controlled diet (i.e., Multi-Component~     Intervention).~      Subjects in all three groups will have 14 brief (15 minute) lifestyle counseling visits the~     first 24 weeks, followed by monthly visits in weeks 25-52. This is the schedule and duration~     of counseling visits recommended by CMS. Counseling sessions will be delivered by a~     physician, nurse practitioner or registered dietitian (RD) working in consultation with the~     former providers.~      Subjects in all three groups also will have brief physician visits at weeks 1, 4, 8, 16, 24,~     36, and 52 (total of 7 visits). These visits are needed for subjects in both liraglutide~     groups to monitor their response to the medication. These visits are included for subjects in~     CMS-Alone to match the intensity of medical care provided the two other groups.~      The primary outcome is % reduction in initial body weight, as measured from randomization to~     week 52. Secondary outcomes include the proportion of participants who at week 52 lose >5%,~     >10%, and >15% of initial weight, as well as % reduction in weight at week 24 and the~     proportion of participants who meet the three categorical weight losses at this time. The~     secondary efficacy measures include changes (from randomization to week 52) in cardiovascular~     disease (CVD) risk factors, glycemic control, mood, quality of life, eating behavior,~     appetite, sleep, and satisfaction with weight loss.~      Safety endpoints will include physical examination, adverse events (AEs), standard laboratory~     tests, and mental health assessed by the Columbia Suicidality Severity Rating Scale (C-SSRS)~     and Patient Health Questionnaire (PHQ-9).~      Statistical Analysis. Using a sample size equation for longitudinal clustered samples, a~     randomization sample of 50 subjects in CMS-Alone, 50 in CMS-Liraglutide, and 50 in the~     Multi-Component Intervention provides >80% power to detect the two primary contrasts to be~     statistically significant. This estimate allows for 20% attrition during the 52-week trial,~     resulting in approximately 40 treatment completers per group. The ITT longitudinal~     statistical design will further improve power by allowing the inclusion of available data for~     non-completers and the adjustment of possible variance reducing baseline covariates.~   "
50045|NCT02911805|"~     This study will determine whether blood biomarker changes predict sight-saving benefits of~     exercise.~   "
50046|NCT02911792|"~     The investigators propose to treat newly diagnosed, hyperfiltering T2DM patients with or~     without microalbuminuria with dapagliflozin or metformin for 4 months. The metformin-treated~     group will serve as controls for improved glycemic control, since the investigators have~     shown that insulin therapy to normalize A1c reduces hyperfiltration and kidney size in T1DM~     patients.~   "
50047|NCT02911779|"~     In order to determine the optimal angle to perform an episiotomy, the investigators assessed~     the angle of marked episiotomy lines at the first stage of labor and at the time of crowning~     of the head.~      Incision lines for mediolateral episiotomy were pre-marked on the perineal skin at 30°, 45°,~     and 60° angles from the midline, at the first stage of labor, in women with singleton~     pregnancies. The angles of the marked lines were measured again at crowning of the head.~     Mediolateral episiotomy was performed only for obstetric indications.~   "
50048|NCT02911766|"~     Chlorhexidine is the gold standard of dental plaque prevention, but which concentration is~     the most effective is not known. The aim of the present study was to compare the plaque and~     gingivitis inhibiting effect of commercial products containing 0.2%, 0.12% and 0.06%~     chlorhexidine in a modified experimental gingivitis model.~      In three groups of healthy volunteers, experimental gingivitis was induced and monitored over~     21days, simultaneously treated with the commercial solutions containing 0.2%, 0.12% and 0.06%~     chlorhexidine. The maxillary right quadrant of each individual received mouthwash only,~     whereas the maxillary left quadrant was subject to both rinsing and mechanical oral hygiene.~     Compliance and side effects were monitored at days 7, 14, and 21. Plaque and gingivitis~     scores were obtained at baseline and day 21.~      The commercial mouthwash containing 0.2% chlorhexidine resulted in statistically~     significantly lower plaque scores than the 0.12 and 0.06% mouthwashes after 21 days use,~     whereas no statistically significant difference was found between the effect of the two~     latter mouthrinses.~      A commercial available mouthwash containing 0.2% chlorhexidine proved statistically~     significant better effect in preventing dental plaque than 0.12% and 0.06% solutions.~   "
50049|NCT02911753|"~     This study aims to 1) assess the feasibility and acceptability of a prescribed beverage~     intervention in 50 obese Hispanic adults ages 18-64 years over 6 weeks; and 2) assess~     preliminary effects of the beverage intervention on cholesterol and triglyceride levels as~     well as other markers of health such as blood pressure, glucose and markers of inflammation.~     This project, if successful, will provide early evidence that targeting dietary behavior~     around beverage intake could be a novel and easily adopted approach to reduce the burden or~     delay the onset of metabolic abnormalities in obese Hispanic adults. The expected outcome of~     the proposed project is the identification of feasible and appropriate beverage intervention~     strategies to improve engagement and adherence to dietary modification approaches for control~     of metabolic health indicators in this vulnerable ethnic group.~   "
50050|NCT02911740|"~     Tuberculosis (TB) is one opportunistic infection often seen in HIV individuals. In 2013,~     there were an estimated 31,800 HIV-TB co-infection cases and 6,100 HIV-related deaths due to~     TB in the Americas. Due to the non-specific nature of its clinical symptoms, TB can be~     confused with various diseases such as histoplasmosis, sarcoidosis, lymphoma, and pneumonia.~     In Panama, where Histoplasma capsulatum is endemic, diagnosing TB versus histoplasmosis based~     on clinical symptoms can be difficult. In Panama, approximately 7.65% of HIV patients are~     co-infected with histoplasmosis, and there is a 30% mortality rate in HIV-histoplasmosis~     patients in Latin America. Due to similar clinical features, misdiagnosis of active TB and~     disseminated histoplasmosis in endemic regions may lead to incorrect antibiotic management,~     which in turn results in unnecessary toxicity, antibiotic resistance, and monetary~     expenditures. The investigators interests lie in increasing TB diagnostic accuracy using a~     simple urine dipstick test and evaluating physician response to new diagnostic testing, in~     order to reduce misdiagnosis and improve health outcomes in the HIV population.~   "
50051|NCT02911727|"~     Cesarean section (CS) is a procedure with prolonged hospital stay compared to the routine for~     normal vaginal delivery in multiparas. The difference is caused mainly by postoperative pain~     but improvements in management of pain may change this situation and make early discharge~     possible. However, several aspects need to be considered.~      The aim of this project is to evaluate fast-track discharge for multiparas after elective CS~     concerning neonatal and maternal complications as well as the parents' sense of security and~     well-being.~      The study is a randomized controlled trial including 142 women allocated to either 1) the~     intention to discharge within 28 hours followed by a home visit or 2) standard discharge~     after at least 48 hours after elective CS.~      This study will be among the first evaluating fast-track discharge after CS in a European~     context. If a positive outcome is achieved, we expect that fast-track discharge can be~     implemented with improved quality and reduced costs in postnatal care following elective CS.~   "
50053|NCT02911701|"~     NSAIDs, specifically cyclo-oxygenase (COX) inhibitors, are known to increase blood pressure~     over time in non-pregnant adults, but the effect of COX-inhibitors on blood pressure in the~     setting of preeclampsia have not been well studied. This study aims to assess the effect of~     avoiding COX-inhibitors on postpartum blood pressure control among women diagnosed with~     preeclampsia with severe features. Eligible women will be randomized to receive either~     acetaminophen or ibuprofen for postpartum pain control. Both agents are first line therapies~     for pain control although ibuprofen has better pain control than acetaminophen. The primary~     outcome will be duration of postpartum severe-range hypertension.~   "
50054|NCT02911688|"~     To study the effects of 1200mg gamma tocopherol (yT), a form of vitamin E, given daily on the~     response of the airway in mild asthmatics after exposure to ozone (O3)~   "
50055|NCT02911675|"~     Traumatic brain injury (TBI) is a leading cause of death following injury in civilian~     populations and is a major cause of death and disability in combat casualties. While primary~     brain injury cannot be reversed, the management of severe TBI focuses on the mitigation of~     secondary injury mechanisms which occur as part of the downstream effects of the primary~     damage to the brain. Many secondary injury mechanisms are manifested clinically as elevated~     intracranial pressure (ICP) and cerebral perfusion pressure (CCP). This level and duration of~     elevated ICP is strongly associated with poor long term patient outcome.~      Currently, there are two invasive techniques that are used at our facility for monitoring ICP~     and CPP. The first method requires the placement of an intra-parenchymal fiberoptic pressure~     monitor (IPM), also known as a camino, into the brain tissue that measures and displays ICP~     continuously. The second method requires placement of an extracranial ventricular drain (EVD)~     which both measures ICP when it is closed or clamped and also allows for therapeutic drainage~     of cerebral spinal fluid (CFS) to reduce pressure within the skull when it is open.~      While clinical practices vary greatly across institutions, current clinical practice at our~     institution when using the EVD for ICP management is to allow continuous therapeutic CSF~     drainage and to manually close the drain for ICP assessment on an hourly basis. However, in a~     retrospective of study of TBI patients at our institution with simultaneous IPM and EVD~     placement, a spike in ICP was noted to correspond with the clamping of the EVD which often~     remained elevated for 15-30 minutes before returning to baseline. Due to the strong~     association between poor patient outcome and elevated ICP, this finding is alarming. These~     findings have important implications for procedures to not only treat elevated ICP, but also~     prevent potentially harmful intermittent elevations in ICP. Therefore, this study seeks to~     prospectively investigate the association between EVD clamping and elevated ICP.~      Specifically, this study has 2 main objectives:~        1. Evaluate the need for an optimized device that can simultaneously measure intracranial~          pressure and drain CSF without requiring potentially harmful clamping.~        2. Provide data in support of retaining or modifying current clinical practices regarding~          intermittent versus continuous monitoring during periods of therapeutic drainage of CSF.~   "
50056|NCT02911662|"~     This is a prospective randomized controlled day comparing the efficacy of three-day~     antimicrobial treatment of asymptomatic bacteriuria (ASB) in pregnancy to the standard~     seven-day treatment. Half the patients will receive 3-day treatment and the other half will~     receive 7 days of antibiotics.~   "
50057|NCT02911649|"~     Cancer-related fatigue (CRF) can be experienced by individuals with Prostate Cancer (PC),~     which can have profound effects on their well-being. Although physical activity has been~     shown to improve CRF, the recommended levels are generally not met. Step count and distance~     traveled information can help individuals to increase their physical activity. Wearable~     technology (WEAR) provides the user with feedback of their physical activity which can~     motivate behaviour change. Similarly, education workshops (EDU) on the effects of sedentary~     behaviour and physical activity may also reduce sedentary behaviour.~      The objectives of this study are to evaluate the effects of WEAR and EDU on sedentary~     behaviour and CRF, and to explore the feasibility of WEAR in this population. Participants in~     this study will be randomly assigned into WEAR, EDU, WEAR+EDU, or control over a three-month~     intervention. Assessments at baseline, post-intervention and a 3-month follow up will~     evaluate CRF, quality of life and level of sedentary behaviour, and use of WEAR devices.~      The results from this study will provide evidence-based knowledge on the impact of WEAR and~     EDU on sedentary behaviour and CRF, and an understanding on the use of technology within the~     PC population. These results can shape the development of programming for CRF and the use of~     scale-able technology-based interventions/approaches in this population.~   "
50058|NCT02911636|"~     Stereotactic Ablative Radiation(SABR) 35 Gy in 5 fractions, once weekly to prostate with~     simultaneous intraprostatic boost to the MR detected nodule up to 50Gy + 25 Gy in 5~     fractions, once weekly simultaneously to seminal vesicles (SV's) and pelvic lymph nodes +~     6-18 months of ADT~   "
50059|NCT02911623|"~     To observe early safety and performance of the Shockwave Medical Lithoplasty® System~     (specifically, Lithoplasty® Catheters: 2.5 x 60mm, 2.75 x 60mm, 3.0 x 60mm, 3.25 x 60mm, and~     3.5 x 60mm) in subjects to demonstrate that the Shockwave device can safely and effectively~     deliver localized pulsatile mechanical energy for balloon dilation of calcified, stenotic,~     infrapopliteal arteries.~   "
50060|NCT02911610|"~     The use of arthroscopy with the surgery of wrist fractures has a great health and economic~     impact (prolongs the time of surgery, requires adequately trained personnel, increases the~     time and surgical expenses and the risk of complications, however, in return ameliorate the~     prognosis and improves the functional recovery). There are few clinical trials showing a~     sufficient level of evidence in comparing the results of the surgical treatment of these~     fractures with volar plate and added arthroscopy so it is necessary to perform a clinical~     trial with an appropriate design and a sufficient sample size to elucidate the usefulness of~     arthroscopy in wrist fractures. Therefore, the investigators want to perform an open and~     controlled clinical trial to adequately analyze the role of arthroscopy in the surgical~     treatment of wrist fractures in the investigators hospitals.~      The main objective of the study is to probe the arthroscopy effectiveness in the~     functionality of the injured wrist by PRWE (a questionnaire assessing pain and wrist~     function) between the treatment groups of the trial at 12 months after surgery and for this~     the investigators plan a phase IV multicenter clinical trial.~   "
50061|NCT02911597|"~     The primary objective is to determine if the opioid properties of ketamine are responsible~     for its antidepressant effects. Since naltrexone can block opiate actions, the investigators~     will determine if naltrexone can effectively block ketamine's effects.~   "
50062|NCT02911584|"~     This is the first study comparing the laparoscopic sacropexy with Pelvic Organs Prolapse~     Suspension (POPS) to treat pelvic organ prolapse. This prospective randomized surgical trial~     is designed to test the clinical and functional effects of the two different laparoscopic~     procedures in terms of anatomical correction of the prolapse, post-operative and long term~     morbidity, rate of recurrence and subjective satisfaction of the patient evaluated by a~     quality of life questionnaire.~   "
50063|NCT02911571|"~     This will be a prospective, case-only, study to measure the impact of MMprofiler on treatment~     intention decisions in active Multiple Myeloma patients.~   "
53279|NCT02869555|"~     Database of Institut Paoli-Calmettes patients diagnosed with multiple myeloma~   "
50065|NCT02911545|"~     Non-vitamin K oral anticoagulants (NOAC) have been shown to be safe and effective~     alternatives to warfarin for stroke prevention in patients with nonvalvular AF (NVAF). There~     are yet limited real life data on outcomes following elective cardioversion in AF patients~     treated with NOACs. The aim of this study is to investigate the complications and the use of~     NOACs in AF patients undergoing cardioversion.~   "
50066|NCT02911532|"~     The purpose of this study is to determine whether tissue engineering conjunctiva is effective~     in the treatment of pterygium and atretoblepharia.~   "
50067|NCT02911519|"~     This study evaluates the addition of psychoeducation to treament as usual in the treatment of~     adults with schizophrenia for relapse prevention. Half of partipants will receive a brief (5~     sessions) psychoeducation intervention and treatment as usual in combination, while the other~     half will receive treatment as usual only.~   "
50068|NCT02911506|"~     The aim of the study is to evaluate the impact of sleep quality on extubation failure rate in~     intensive care unit patients at high risk.~   "
50069|NCT02911493|"~     To determine the change in sedentary time and number of steps/day for older patients with~     heart failure at risk for mobility disability who receive a program to decrease sedentary~     behavior versus a standard program to increase exercise.~   "
50070|NCT02911480|"~     The current study is designed as a phase I multiple dose study to evaluate the~     pharmacokinetics and bioavailability of [14C]-labelled oxytocin in healthy women.~   "
50071|NCT02911467|"~     This is a prospective imaging study evaluating the utility of baseline metabolic MR imaging~     with Hyperpolarized Pyruvate (HP) (13C) as a predictive response biomarker to androgen~     signaling inhibition in patients with castration-resistant prostate cancer.~   "
50072|NCT02911454|"~     A prospective, multi-country, open label study to describe the stool characteristics and~     behaviour as well as the parents' experience in infants receiving a recently launched infant~     formula in a real life situation.~   "
50073|NCT02911441|"~     This study evaluates a cognitive behavioral therapy intervention for mothers with symptoms of~     anxiety and depression living in insecure environments using a randomized controlled~     methodology. Key outcomes of interest include maternal mental health and infant cognitive~     development. The intervention will be delivered by community mental health workers who will~     be trained to administer 8 to 12 cognitive behavioral therapy sessions.~   "
50074|NCT02911428|"~     The purpose of this study is to evaluate the post-vaccination immune status at different time~     points in subjects immunized against Ebola Virus Disease; to select an optimal regimen of~     product administration; and, to assess safety of medicinal product GamEvacVector-Based~     Vaccine against Ebola Virus Disease, 0.5 ml+0.5 ml/dose, following the immunization with a~     half (0.25 ml+0.25 ml/dose) and full (0.5 ml+0.5 ml/dose) therapeutic doses.~   "
50075|NCT02911415|"~     The purpose of this study is to evaluate the post-vaccination immune status at different time~     points in subjects immunized against Ebola Virus Disease; to select an optimal regimen of~     product administration; and, to assess safety of medicinal product GamEvac-Combi - Combined~     Vector-Based Vaccine against Ebola Virus Disease, 0.5 ml+0.5 ml/dose, following the~     immunization with a half (0.25 ml+0.25 ml/dose) and full (0.5 ml+0.5 ml/dose) therapeutic~     doses.~   "
50076|NCT02911402|"~     Sea sickness syndrome is present for 80% of persons on board when the boat rotation missions~     Astrolabe, sometimes there is a risk of very significant dehydration. A special unit~     specialized in the fundamental study of the vestibular system (inner ear), sensory organ at~     the base of visual-vestibular conflict inducing this syndrome, also provides medical support~     for parabolic flights (flight reproducing weightlessness) where this syndrome is strongly~     present. The goal of the study is to assess the frequency of occurrence of this sea sickness~     syndrome on the Astrolabe, to understand the triggers (type of boat movements, personality~     traits, anxiety / stress) without changing habits on board for those on board taking a~     antinaupathique treatment given by the ship's doctor. This study will be done in~     collaboration between INSERM U 1075 (France) and the Laboratory of military research VIPER~     specialized in extreme environments (Belgium). The ultimate goal will be to provide the best~     recommendations and the best treatment regimen to alleviate as best as possible the symptoms~     of people on board of the Astrolabe so scientists on board can perform their work.~   "
50077|NCT02911389|"~     The purpose of this study is to determine if unsupervised, home rehabilitation delivered by a~     web-based platform or paper manual is a safe and effective alternative to outpatient physical~     therapy after total knee replacement.~   "
50078|NCT02911363|"~     The main purpose of this study will be to two-fold; firstly to determine whether the use of a~     Captivator tissue cassette has an effect on the preservation of tissue histology (minimizing~     artifactual curling) , and secondly to determine whether the use of a intraprocedural~     cassette is practical. The investigators believe that this will greatly aid in elucidating~     the best technique for optimizing performance of EMR for esophageal lesions.~   "
50079|NCT02911350|"~     The purpose of this study is to determine if the combination therapy of Hormone, Paclitaxel~     and Radiation therapy are effective in treatment of locally advanced prostate cancer~   "
50080|NCT02911337|"~     The purpose of this study is to examine the efficacy of an intensive, supervised, lifestyle~     modification program on symptoms and signs of heart failure as well as laboratory and~     echocardiographic measures of cardiac structure and function. This will be a 6 month trial in~     50 patients with a clinical diagnosis of heart failure with preserved ejection fraction~     (HFpEF). Patients will be enrolled in the Medical University of South Carolina weight~     management 15 week lifestyle change program which will involve weekly visits that rotate~     among the clinical specialities (dietary, exercise and behavioral) and scheduled visits with~     the research Registered Nurse. Each patients baseline data will be used as the control and~     compared with the same measurements at the 6 month end point.~   "
50081|NCT02911324|"~     The purpose of this pilot research study is to test the effects of a medication called~     nabilone (Cesamet) in adults with obsessive-compulsive disorder (OCD). Participants will~     receive either nabilone on its own, or nabilone in combination with a form of~     cognitive-behavioral therapy (CBT) called exposure and response prevention (EX/RP). Nabilone~     is a synthetic cannabinoid and acts on the brain's endocannabinoid system, which has been~     hypothesized to play a role in OCD. Nabilone is approved by the FDA for the treatment of~     chemotherapy-induced nausea and vomiting. It is not FDA-approved for treating OCD.~   "
53280|NCT02869542|"~     Database of Institut Paoli-Calmettes patients diagnosed with lymphoma~   "
50082|NCT02911311|"~     Panretinal photocoagulation (PRP) has been the standard treatment for Proliferative diabetic~     retinopathy (PDR) since the Diabetic Retinopathy Study demonstrated its benefit nearly 40~     years ago,but PRP has inevitable adverse effects on visual function. Intravitreal injection~     of vascular endothelial growth factor(VEGF) can induce short-term regression of retinal~     neovascularization(NV). The purpose is to assess and compare the efficacy and safety between~     intravitreal injection of conbercept and PRP.~   "
50083|NCT02911298|"~     This is a Phase I, open label, single-site trial to evaluate the in vivo release~     characteristics in the gastrointestinal tract of metronidazole benzoate capsules designed to~     disintegrate in the large intestine. This will be examined by means of metronidazole plasma~     levels and scintigraphic images in healthy subjects. Overall, nine subjects will be evaluated~     for each formulation prototype. Two formulation prototypes will be investigated. Each subject~     will receive one radio-labelled capsule only.~   "
50084|NCT02911285|"~     As a result of sustained operations in Afghanistan and Iraq, there are an increasing number~     of U.S. military Veterans with substance use disorders and comorbid posttraumatic stress~     disorder (PTSD). If left untreated, individuals with substance use disorders and PTSD are at~     increased risk for developing other mental health problems (e.g., depression, anxiety),~     suicidal ideation and attempts, medical problems, reduced resiliency and military readiness,~     vocational problems, and family/social impairment. This study will determine the benefits of~     N-acetylcysteine (NAC) in treating alcohol use disorder and comorbid post-traumatic stress~     disorder (PTSD) among military Veterans.~   "
50085|NCT02911272|"~     Objective: To compare active labour outcomes in nulliparous women at term supervised with a~     partograph with the action line placed at either 2 hours or 4 hours and to determine whether~     the 2-hour action line placement is better for the prevention of prolonged labour.~      Design: Randomised controlled trial.~      Setting: A university teaching hospital in Nigeria.~      Population: Nulliparous women in labour at term.~      Method: Nulliparous women in labour were randomly supervised with a partograph with the~     action line placed at 2 hours (n=320) or 4 hours (n=320). Oxytocin augmentation, when~     required, was used only at the 2-hour (n=87) or 4-hour (n=61) action lines. Progress~     monitoring was the same in both groups.~      Main outcome measure: The primary outcome measure was the prolonged labour rate. The~     secondary outcome measures were the mode of delivery and neonatal outcome.~   "
50086|NCT02911259|"~     The level of suction on post-operative chest tubes after video-assisted thoracoscopic surgery~     (VATS) lobectomy for lung cancer has previously shown to affect duration of drainage. These~     results, however, are based on traditional drainage systems with water seal and need to be~     confirmed using digital drainage systems.~      Hypothesis: Suction of -2 cmH2O is equal to or superior compared with standard suction of -10~     cmH2O when looking at chest tube duration and complications.~   "
50087|NCT02911246|"~     Malnutrition is defined by an energy supply deficit, protein, macro-molecules or~     micro-nutrients, resulting from an imbalance between nutrient intakes and metabolic needs of~     the body. It concerns 40 to 60% of patients upon entry into resuscitation and influences~     their prognosis. Studies over the past decade have shown that nutritional deficiency~     increases the morbidity and mortality in intensive care.~      Several clinical and biological parameters were evaluated as markers of malnutrition,~     including the ratio of urea / urine creatinine.~      The report would identify patients in a state of malnutrition, to optimize their nutritional~     care.~      This setting is easy to obtain in all patients by simple urine collection unlike other~     clinical and biological criteria of resuscitation malnutrition assessment.~      This ratio of urea / urien creatinine would optimize energy intake of critically ill~     patients, for which nutritional management methods are widely debated.~   "
50088|NCT02911233|"~     Hemophilia A is a rare X chromosome-linked recessive bleeding disorder that concerns one~     individual in 5000. In its severe form, hemophilia A is a life-threatening, crippling~     hemorrhagic disease. The treatment of bleeding episodes in hemophilia A patients involves the~     administration of exogenous human FVIII to restore normal hemostasis. The main complication~     of the substitutive treatment of hemophilia A is the development, in 15 to 30% of the cases,~     of anti-FVIII antibodies (FVIII inhibitors) that neutralize the pro-coagulant activity of~     therapeutically administered FVIII. In 2003, the average annual cost of care for a patient~     with hemophilia A was evaluated to be equal to 63,000 euros (2), which, in France (6000~     patients), represents an annual budget of 378 million euros.~      In order to reduce the cost of treatment and to bypass this complication, different~     therapeutic strategies (new products or adjunctive therapeutic options) have been explored,~     including platelet infusion, tranexamic acid, amino caproic acid, molecules that block tissue~     factor pathway inhibitor, combination of phospholipid -Factor Xa- Factor XIII and antibodies~     directed to the Tissue Factor Inhibitor Pathway (TFPI). Recently, Soluble thrombomodulin~     (Solulin) have been developed. This molecule may be used to partially correct the premature~     lysis defect in Factor VIII deficient plasma through an activated TAFI - dependent mechanism.~      With a long half-life (15- to 30-hour) and effective dose range estimated to range from the~     sub-nanomolar to approximately 40nM, Solulin could potentially be administered on a weekly~     basis and provide the basis for a factor-sparing regime that would cut costs and make therapy~     more widely available. However, before proceeding to advanced trials, safety concerns~     stemming from the anticoagulant properties of Solulin must be addressed. The development of~     Solulin mutants lacking protein C activation capacity would make this concern redundant. At~     the same time, such mutant molecules are likely to possess an effective dose range.~      Our project is to compare the behavior of recombinant Solulin and mutants of Solulin lacking~     protein C activation capacity with respect to their ability to stabilize fibrin clots in~     whole blood of humans with different coagulation factor deficiencies (hemophilia A,~     hemophilia B and rare blood coagulation deficiencies (factor X, VII, V).~   "
50089|NCT02911220|"~     The intrinsic asthma (atopic or not) is a particular phenotype marked by an early later~     symptoms, increased severity, sensitivity associated with nonsteroidal anti-inflammatory~     drugs (NSAIDs), a sinonasal polyposis and eosinophilia.~      Unlike allergic asthma, this form does not today demonstrated its genetic character. However,~     the existence of familial forms of asthma in this region Pays de La Loire led us to~     hypothesize the existence of genetic variations can explain some familial forms of non-atopic~     asthma. Corresponding genes may be relevant to understanding the pathophysiological pathways~     involved in the more common sporadic forms.~      The investigators propose a study combining genetic linkage analysis and complete sequencing~     exomes to identify one or more genetic abnormalities associated with non-atopic asthma. The~     clinical stage essential for mutation identification is to identify and recruit large~     families with members affected by non-atopic asthma and ensure accurate phenotyping of all~     individuals recruited over several generations.~      The aim of this study is to create a cohort of families who have more members within them~     non-atopic asthma. A high genetic combined exome sequencing throughput analysis in a family~     linkage study will then reveal the presence or absence of genetic variations associated with~     intrinsic asthma.~   "
50718|NCT02902978|"~     The primary purpose of this study is to evaluate the safety, tolerability, and~     pharmacokinetics of a single dose of E6130 in Japanese healthy adult male participants.~   "
50090|NCT02911207|"~     There are very few studies on emotion management in chronically ill patients. They usually~     include small sample size (less than 30 persons) and are not randomized controlled trials.~     However, emotion management is an essential coping skill in mental well-being and quality of~     life and is the subject of numerous studies in psychology.The investigators hypothesized that~     a creative and physical activities combination in chronically ill will promote the~     strengthening of emotion management skill. The investigators will conduct an innovating study~     combining quantitative and qualitative variables in a randomized controlled trial to confirm~     our hypothesis.~   "
50091|NCT02911194|"~     Under double-blind, placebo-controlled, cross-over conditions, the short-term effects of use~     of A1 beta casein free milk (a2 milk) and milk containing A1 beta casein will be compared in~     a sample of pre-pubescent boys diagnosed with an autism spectrum disorder (ASD) with~     concurrent features of attention-deficit hyperactivity disorder (ADHD).~   "
50092|NCT02911181|"~     Observational study to investigate nutrition state in all admitted patients in ICU.~     Measurement by BIVA and SNAQ score.~   "
50093|NCT02911168|"~     The purpose of this study is to compare the proximal intercostal block to the more medial~     (classic) ultrasound-guided paravertebral block. The investigators hypothesize that the~     proximal intercostal block will allow for improved needle visualization, shorter block time,~     and improved safety profile compared to the classic paravertebral bock.~   "
50094|NCT02911155|"~     Background:~      The field of nuclear medicine has changed a lot in the past decades. Technology has gotten~     better, so patients are exposed to less radiation. But now workers are doing procedures more~     often and using lead aprons less. So they may be exposed to more radiation. This may put them~     at higher risk for cancers and other health problems that are related to radiation.~     Researchers want to collect data from technologists to learn more about the risks and~     appropriate doses of radiation.~      Objective:~      To learn more about the risks and appropriate doses of radiation for nuclear medicine~     technologists.~      Eligibility:~      Adults who were first certified in nuclear medicine technology in the United States after~     1980. They must be living in the United States. They must not be participants in the USRT~     study.~      Design:~      Participants will be recruited online.~      Participants will complete an online survey. It will take about a half hour. This will have~     questions about their work with nuclear medicine procedures. There will be questions about~     the kinds of procedures and how often they do them.~      Participants will give a short work history. This will include the names of current and past~     employers.~      Participants will allow researchers to get records of their film badge dose readings. These~     will come from dosimetry providers.~      Dosimetry data will not be shared with participants. Researchers can t ensure the how~     accurate or complete the data are.~   "
50095|NCT02911142|"~     Background:~      Primary effusion lymphoma (PEL) is a rare disease with no standard treatment. Researchers~     want to see if a drug called lenalidomide along with common chemotherapy drugs may be~     effective in treating PEL.~      Objective:~      To test a new treatment for PEL.~      Eligibility:~      People ages 18 and older with PEL.~      Design:~      Participants will be screened with blood tests, imaging studies, a physical exam, and other~     tests.~      Participants will have tests to evaluate their disease. These may include:~      Blood tests~      Scans~      Lumbar puncture. Fluid around the spinal cord will be removed with a needle.~      Bone marrow removed with a needle and studied~      Samples of skin or lymph nodes removed~      Fluid removed from around organs~      Lung and eye tests~      Tubes with cameras taking pictures of airways or digestive tract~      Participants will take lenalidomide pills for 10 days. They will keep a pill diary.~      Participants will have a catheter (small tube) placed in the large vein in the arm or chest.~      Participants will get DA-EPOCH-R as intravenous infusions by catheter over several days. This~     will be repeated in 21-day cycles. Most participants will have 6 cycles.~      Participants will get the drug filgrastim by injection under the skin. They will get the drug~     methotrexate injected into the spinal fluid.~      During the study, participants will have the following tests done at least once:~      Medical history~      Physical exam~      Blood, urine, and stool tests~      Lesions photographed and measured~      Lumbar puncture~      Participants will have follow-up visits for 5 years. They will repeat the screening tests~     plus have urine and stool tested.~      Participants may be contacted later by phone to see how they are doing.~   "
50096|NCT02911129|"~     Background:~      After a stroke, the balance between the two halves of the brain can be lost. This may cause~     people to lose the ability to perceive a side of space. This is called neglect. Having people~     wear prism glasses (called PA) can reduce neglect symptoms. Researchers want to find out more~     about how PA, and whether it restores the balance in the brain.~      Objective:~      To learn how prism adaption temporarily changes vision and connections in the brain.~      Eligibility:~      People ages 18 75 with brain damage of the right side of the brain from a stroke or other~     cause, leading to neglect.~      Healthy volunteers ages 18 75.~      Design:~      Participants will have 1 3 visits.~      Participants will be screened with a neurological exam. They may also have:~      Tests of thinking and vision~      Tests to see which eye and hand they prefer~      A pregnancy test~      All participants will:~      Answer questions about their personality, style of thinking, and beliefs.~      Do simple tasks on paper or computer~      Have magnetic resonance imaging. They will lie on a table that can slide in and out of a~     cylinder in a strong magnetic field. Participants will lie still or do computer tasks in the~     scanner.~      Participants may also have:~      Transcranial magnetic stimulation. A brief electrical current passes through a wire coil on~     the scalp. This creates a magnetic pulse that affects brain activity. Participants may be~     asked to tense certain muscles or perform simple actions or tasks.~      PA. They will sit in front of a board and point to a dot on it while they wear prism glasses~     that shift vision to the left or right.~   "
50106|NCT02910999|"~     This study intends to describe the real-life effectiveness and safety of nivolumab in~     advanced NSCLC patients in Germany, as well as the patient profile, pattern of use and the~     quality of life.~   "
50107|NCT02910986|"~     This study will examine behavioral and psychological outcomes of breast density notification~     using a 3-group randomized design comparing usual written notification to two educationally~     enhanced approaches.~   "
50309|NCT02908334|"~     In this study patients will be randomized 1:2 to receive either standard of care treatment or~     standard of care + Sertraline 200mg/day for 2 weeks, then 400 mg/day for 50 weeks for~     treatment of disseminated and meningeal coccidioidomycosis.~   "
50097|NCT02911116|"~     Background:~      Uveitis is an inflammation of the eye that can cause vision loss. It is treated with~     medications and sometimes surgery. However, in many people, treatment does not always prevent~     loss of vision. A new medication, ustekinumab, reduces inflammation in patients with other~     inflammatory diseases. Therefore, it might be helpful in treatment of uveitis.~      Objective:~      To see if ustekinumab is safe and can help people with uveitis.~      Eligibility:~      People ages 18 and older with uveitis~      Design:~      Participants will be screened with:~      Medical and eye disease history~      Physical exam~      Eye exam: The pupil is dilated with eye drops. A machine scans the back of the eye. Pictures~      are taken of the inside of the eye.~      Blood and urine tests~      Tuberculosis test~      Participants will have 6 clinic visits over 28 weeks. Visits lasts 2-3 hours and include:~      Medical and eye disease history~      Physical and eye exams~      Blood and urine tests~      Fluorescein angiography: A needle guides a thin plastic tube into an arm vein. A dye is~      injected into the tube. The dye travels through the veins up to the blood vessels in the~     eyes. A~      camera takes pictures of the dye as it flows through the blood vessels in the eyes.~      Ustekinumab injections at Weeks 0, 4, and 8: The injection is under the skin of the upper~      arm, leg, or abdomen.~      Participants will have their uveitis monitored and receive standard uveitis care during the~     study.~   "
50098|NCT02911103|"~     Researchers want to test a procedure called deep brain simulation (DBS) to treat focal hand~     dystonia (FHD). A device called a neurostimulator is placed in the chest. It is attached to~     wires placed in brain areas that affect movement. Stimulating these areas can help block~     nerve signals that cause abnormal movements.~      Objectives:~      To test DBS as treatment for FHD. To learn about brain and nerve cell function in people with~     dystonia.~      Eligibility:~      People ages 18 and older with severe FHD who have tried botulinum toxin treatment at least~     twice~      Design:~      Participation lasts 5 years.~      Participants will be screened with:~      Medical history~      Physical exam~      Videotape of their dystonia~      Blood, urine, and heart tests~      Brain MRI scan~      Chest X-ray~      Neuropsychological tests: answering questions, doing simple actions, and taking memory and~     thinking tests.~      Hand movement tests~      Participants will have surgery: A frame fixes their head to the operating table. A small hole~     is made in the skull. Wires are inserted to record brain activity and stimulate the brain~     while they do simple tasks. The wires are removed and the DBS electrode is inserted into the~     hole. The neurostimulator is placed under the skin of the chest, with wires running to the~     electrode in the brain. They will have CT and MRI scans during surgery.~      Participants will recover in the hospital for about 1 week.~      The neurostimulator will be turned on 1 4 weeks after discharge. Participants will have~     regular visits until the study ends. Visits include:~      Checking symptoms and side effects~      MRI~      Movement, thinking, and memory tests~      If the neurostimulator s battery runs out, participants will have surgery to replace it.~   "
50099|NCT02911090|"~     The purpose of this data registry is to prospectively collect data from patients referred to~     an interdisciplinary clinic for pelvic pain and endometriosis to investigate long-term~     patient outcomes, prognosis, predictors, causes, and treatment of pelvic pain and~     endometriosis.~   "
50100|NCT02911077|"~     Background:~      Many bacteria live in the gut. The gut is the tube that moves food from the mouth through the~     stomach to the intestines. Heavy alcohol use disturbs these bacteria. There is evidence that~     the bacteria in the gut may affect anxiety and depression. Researchers want to learn more~     about these bacteria in order to better treat diseases such as alcohol dependence.~      Objective:~      To identify the different bacteria that live in the mouth and gut. Also, to learn if these~     bacteria change as a person goes through alcohol detoxification.~      Eligibility:~      People ages 18 and older who:~        -  Enrolled in screening protocol 14-AA-0181~        -  Are going through detoxification treatment at the Clinical Center~      Design:~      Participants will have physical exams.~      Participants will answer questions about:~        -  Anxiety and depression~        -  Alcohol use~        -  Sleep~        -  Abdominal and oral health~        -  Diet~      Participants will keep a regular record of their diet.~      Participants will have breath alcohol analysis 4 times per day.~      Participants will provide stool and oral specimens at most once a day for the first week.~     Then, they will provide them once a week while they are at the Clinical Center.~        -  For the oral specimen: A small brush rubs the tongue. They may not eat, drink, or~          perform oral care within 2 hours of collection.~        -  For the stool specimen: They will receive a container that fits in the toilet. They will~          let the nurse know right away when the sample is ready.~      Participants will have a dental visit. This consists of an oral exam and oral health~     assessment. The dentist may recommend a cleaning or dental X-rays.~   "
50101|NCT02911064|"~     The goal of this research study is to learn if there is a difference between your~     expectations of how well you will perform daily living activities after short-term inpatient~     rehabilitation and the doctor's expectations of how well you will perform daily living~     activities.~   "
50102|NCT02911051|"~     The clinical study evaluates the safety of a new catheter for Urinary Intermittent~     Catheterisation in self catheterized patients~   "
50103|NCT02911038|"~     The aim of this observational study is: producing complete dental prosthesis with the aid of~     CAD-CAM (Computer aided design & manufacturing) - 3D printing (Stereolithography) technology~     - using as printable material Poli(methylmetacrylate) - PMMA - with Nano TiO2 nanoparticles~     composite completely characterized.~   "
50104|NCT02911025|"~     The purpose of this study is to monitor the effect of Clobazam on sleep and daytime alertness~     in people with Epilepsy.~   "
50105|NCT02911012|"~     The aim of this study is to overcome the current limits of the scoring systems used to~     predict both the thrombotic (VTE) and hemorrhagic (BLD) risk for the patient. The main~     problem of these scoring systems is due to the high rigidity related to the score assigned at~     each risk item. The presence of an item assigns the full score for that item, without the~     possibility to moderate that item's score. The final class of risk, for the patient, is the~     sum of the scores of the selected items. The approach used for the assessment is based on the~     presence or absence of certain items that will be summed.~      Starting from scoring system currently used for VTE (PADUA, CAPRINI, KHORANA) and also for~     BLD (IMPROVE), we will integrate all common items in a single scoring system managed by risk~     management algorithms that can identify the different classes of risk.~   "
51212|NCT02896543|"~     This study evaluates the relationship of change of dendritic cells fractalkine and P-selectin~     in patients with acute myocardial infarction.~   "
50108|NCT02910973|"~     Persistent chronic inflammation is an important underlying event in multiple diseases~     including rheumatoid arthritis, inflammatory bowel diseases and type 2 diabetes. These~     disorders are characterized as inflammatory in part because of the important mediating role~     of pro-inflammatory cytokines in their pathogenesis. This study will investigate whether~     transcutaneous auricular electrical stimulation of the vagus nerve will affect and decrease~     the inflammatory cytokine response in healthy individuals.~   "
50109|NCT02910960|"~     This is a randomized prospective clinical study comparing the Acquire Biopsy Device to~     SharkCore Biopsy Device.~   "
50110|NCT02910947|"~     Two ultrasound guided techniques to give postoperative pain relief to the patients following~     abdominal surgeries would be compared using scoring systems for pain relief and scientific~     methods. while one technique is routinely used, other i.e quadratus lumborum has been~     recently described and relies on posterior deposition of the drug. Both the techniques are~     safe and ultrasound imaging is to be used for guidance.~   "
50111|NCT02910934|"~     This study aims to provide National Malaria Control Programs (NMCP), international donors and~     other key stakeholders with clear evidence on the impact and cost-effectiveness of using~     indoor residual spraying (IRS) with a non-pyrethroid insecticide in a high malaria~     transmission area that has universal long-lasting insecticidal net (LLIN) coverage. This is~     an interventional study with IRS serving as the research intervention.~      The district of Mopeia, in the province of Zambezia, Mozambique will be the study site. This~     is a high transmission area with a malaria parasite prevalence of 54% in children. The~     Ministry of Health distributed LLINs in Mopeia in 2014-2015.~      The NMCP through funding from President's Malaria Initiative Africa Indoor Residual Spraying~     Project (PMI-AIRS) was able to cover half a district with indoor residual spraying. A~     simplified census took place in mid-2016 to determine the number of children five years of~     age and under in the district and enumerate and map the households to assist in~     implementation.~      From the 115 villages/bairros existent in Mopeia, 86 clusters were randomized in a government~     randomization ceremony to either receive IRS with Actellic or maintain no IRS. The IRS was~     implemented through a partnership between the NMCP and PMI-AIRS according to standard~     operational and consent procedures. From each cluster, a cohort of 18 children five years of~     age and under will be followed monthly to assess malaria incidence at the community level in~     both IRS and non-IRS villages. There will be 774 children in the IRS villages and 774~     children in the no-IRS villages (total cohort will be 1548). Additionally, the routine health~     centre reporting system will be strengthened to assess malaria incidence in children five~     years of age and under by passive case detection. Two cross sectional studies in April 2017~     and April 2018, will assess changes in net use, health seeking behaviour and malaria~     prevalence at the community level.~      Entomological data will be collected from both IRS and non-IRS areas to assess the vector~     dynamics and insecticide resistance pattern of the local vector populations from sprayed and~     unsprayed areas. Data on the costs of the implementation as well as health-related~     expenditures at health system and household levels will be collected prospectively throughout~     the study. These costs will be determined using both health system and societal perspectives.~      The incidence rate in IRS and no-IRS areas will be combined with the micro-costing data to~     calculate the cost per case averted at community and health facility level.~      These findings will be disseminated to the NMCP and international donors and stakeholders to~     complement the WHO guidance on combining indoor residual spraying and long-lasting~     insecticidal nets.~   "
50112|NCT02910921|"~     This trial is collaboration between Mayo Clinic, Second Opinion Health (Simon Bloch,~     simon@somobilehealth.com 408-981-3814) and Allergan. Mayo Clinic investigators are conducting~     the clinical trial, Second Opinion Health is providing the software for use in the trial~     (Migraine Alert app for data collection, analysis and machine learning algorithms), and~     Allergan is providing funding.~      The investigators hypothesize that the use of a mobile phone app and Fitbit wearable to~     collect daily headache diary data, exposure/trigger data and physiologic data will predict~     the occurrence of migraine attacks with high accuracy. The objective of the trial is to~     assess the ability to use daily exposure/trigger and symptom data, as well as physiologic~     data (collected by Fitbit) to create individual predictive migraine models to accurately~     predict migraine attacks in individual patients via a mobile phone app.~   "
50113|NCT02910908|"~     Elderly (i.e.>75 yrs) represent about 40% of incident dialysis patients in the French REIN~     Registry and are growing population in high income countries. Those elderly patients with CKD~     have a high risk of dying within the first months of dialysis start or could have a good~     long-term prognosis suggesting kidney transplantation access. Elderly patients with CKD also~     have a higher risk of dying than reaching ESRD. Therefore, outcomes of elderly patients with~     advanced CKD need to be better described and understood to be able to give accurate~     information to the patients and their relatives and help decision making concerning the~     treatment strategy including several options (i.e preemptive kidney transplantation, in~     center or home dialysis and conservative care). In France we have information about patients~     who started dialysis with French dialysis registry (REIN) but not about elderly patient~     treated with conservative care. Then we don't have information about description of the~     therapeutic project in this population and their evolution in a prospective cohort design.~     Finally we need to identify patients with high risk of early mortality to help shared~     decision making for better care organisation.~      The project of the study is the development of a French multicenter prospective cohort~     including elderly patients more than 75 years old reaching ESRD. Objectives are as follow:~      Description of the characteristics of the population such as, clinical and social conditions,~     medicine treatment, therapeutic project declared by nephrologist and laboratory value at~     inclusion.~      Description of the evolution of therapeuic project, kidney function and the outcomes defined~     as death or dialysis or kidney transplantation.~      Development of a mortality prognosis tools to help decision making in this population.~   "
50114|NCT02910895|"~     Outside the setting of well-designed prospective clinical studies, the current standard~     preoperative RT should be a conventionally 1.8-2 Gy fractionated regimen to a total dose of~     50 Gy in 5-6 weeks. However, given the vast diversity of sarcoma subtypes, it is also~     unlikely to assume a uniform therapeutic management to be optimal for all sarcomas alike.~     Other than 2 Gy fraction sizes and/or 50 Gy total dose series have been investigated in the~     past and should be further exploited in the future, but the practical implementation in~     humans is hampered by the rarity of the disease.~      The current systemic treatment of sarcomas consists of both the older cytotoxic~     chemotherapies and the newer targeted therapies like tyrosine kinase inhibitors. But it is~     hard to predict which patients will respond to which specific systemic treatment. This leads~     to worse prognoses and unnecessary toxicity for sarcoma patients. Despite the fact that the~     number of sarcoma patients in current studies is too small with a mix of different subtypes,~     some subtypes show a better response than other subtypes. This platform may form the basis~     for preclinical translational investigations with radiotherapy and various systemic~     treatments.~   "
50115|NCT02910882|"~     This is a single arm phase II trial assessing the potential activity of combination PEGPH20~     plus Gemcitabine with radiotherapy in ten patients with localized, unresectable pancreatic~     adenocarcinoma.~   "
50479|NCT02906111|"~     The purpose of this study is to determine whether the vaginal estriol before vaginal surgery~     for pelvic statics disorders is more efficacy of no estriol treatment on vaginal health and~     quality of life.~   "
50116|NCT02910869|"~     This observational study will investigate the potential clinical utility of the Pathway Fit®~     test by investigating whether patients who successfully lose weight (defined as losing at~     least 5% of body weight 8 weeks after initiation) in the MOVE! or TeleMOVE! Weight Management~     programs have a distinct nutrigenetic profile over those that were unable to lose a~     significant amount of weight. We will use electronic records to identify all individuals who~     have successfully completed the MOVE! program (i.e. attended the full 8 week course) or~     TeleMOVE! program. In addition we will find age- and gender- matched individuals who attended~     and completed the MOVE! or TeleMOVE! programs but did not lose weight. After completion of~     the MOVE! or TeleMOVE! programs Veterans will submit a saliva sample for the Pathway Fit®~     test. Also, blood will be collected for storage for further studies on metabolomics. The~     start and end weight of all participants will be recorded. The nutrigenic profiles of those~     with successful weight loss will be compared to those less successful to determine if this~     cohort has a particular genetic profile.~   "
50117|NCT02910856|"~     ELDERL-IE is a multicenter national prospective observational study.~      The main objective is to describe geriatric characteristics (comorbidities, cognitive status,~     autonomy, nutritional status, balance and walking) in patients aged 75 years or older with~     infective endocarditis (IE).~      The secondary objectives are to assess the impact of geriatric features on the medico -~     surgical care and on morbidity and mortality at 3 months after the end of the~     hospitalization, and to describe the initial clinical presentation and diagnostic modalities~     in the IE elderly.~   "
50118|NCT02910843|"~     Despite treatment of locally advanced rectal cancer relapses are frequent. Several attempts~     to improve these results with therapy intensification have shown modest effect on disease~     free survival (DFS) and overall survival (OS). Recent studies with addition of sorafenib and~     cediranib revealed promising effect on tumor response with acceptable toxicity. Regorafenib~     is a multi tyrosine kinase inhibitor (TKI) with a broad mechanism of action. Therefore this~     trial investigates if similar results can be achieved as with sorafenib or cediranib.~   "
50119|NCT02910830|"~     The role of tobacco in osteoarthritis remains controversial. The Khoala cohort is the first~     multicenter French cohort of subjects with knee and / or hip osteoarthritis prevalent . It~     guarantees its methodology great representativeness and therefore an interesting material for~     the study of risk factors in the population. In addition, it should have little here~     Radiographs of hands for all its patients. It therefore has the opportunity to study a~     possible relationship between tobacco and hip osteoarthritis , knee and hand but also to~     study the relationship between tobacco and structural evolution of hip osteoarthritis and /~     or symptomatic knee.~   "
50120|NCT02910817|"~     RCT to investigate whether metformin co-treatment would improve IVF outcomes in overweight~     and obese women with PCOS.~   "
50121|NCT02910804|"~     This is an open-label positron emission tomography/near infrared (PET/NIRF) study to~     investigate the imaging navigation performance and evaluation efficacy of dual modality~     imaging probe 68Ga-BBN-IRDye800CW in glioblastoma (GBM) patients. A single dose of~     40μg/111-148 Mega-Becquerel (MBq) and 1.0 mg/ml 68Ga-BBN-IRDye800CW will be injected~     intravenously before the operation and intraoperative respectively. Visual and~     semiquantitative method will be used to assess the PET images and real-time margins~     localization for surgical navigation.~   "
50122|NCT02910791|"~     Atopic dermatitis and psoriasis are two skin diseases often associated with bacterial~     infections and inflammation. Studies indicate that skin cells from these patients may have~     some changes that make these patients more susceptible to bacterial infections. Inflammatory~     environment may have an effect on the function of skin cells.~      The purpose of this study is to learn more about skin cells (keratinocytes and fibroblasts)~     and how they regulate skin barrier function. To study this we need to establish skin cells~     that can be grown in the laboratory. We will use small skin biopsies from patients with~     atopic dermatitis, psoriasis and healthy people as a source of these cells. Since these skin~     cells have a limited lifetime when grown in laboratory as part of the project we would like~     to modify them, which allows them to grow for long time in the research laboratory. Some of~     the collected skin biopsies and isolated skin cells will be used to examine what gene~     products they make.~   "
50123|NCT02910778|"~     To test the effect of atorvastatin or placebo in combination with ticagrelor on ACh-induced~     vasodilatation of the forearm resistance vasculature as assessed by forearm blood flow (FBF)~     measurement before and 10 min after a 20 min forearm ischemia. The area under the dose-effect~     curve (AUC) of different ACh doses will be calculated and compared between treatment groups~     (atorvastatin + ticagrelor vs. placebo + ticagrelor) and different time points (pre-ischemia~     vs. post-ischemia).~   "
50124|NCT02910765|"~     effects of methylene blue and ozone O3 therapy effects in early sepsis management , and their~     implications upon outcome~   "
50125|NCT02910752|"~     For acute leukemia patients with early relapse after allogeneic stem cell transplantation,~     the overall outcome is poor. In this study, we evaluate the treatment outcome and safety of~     chemotherapy with Cladribine, cytarabine and mitoxantrone followed by peripheral stem cell~     support from the original donor.~   "
50126|NCT02910739|"~     This study consists of Part I and Part II. The purpose of Part I is to compare the plasma~     pharmacokinetics of verubecestat (MK-8931) following administration of a single oral dose of~     40 mg MK-8931 to participants with moderate hepatic insufficiency (HI) to that of healthy~     matched controls. A safety and pharmacokinetic analysis will be performed in order to support~     the decision to continue with part II. If a decision to continue with part II is made,~     participants with mild HI will be enrolled to receive a single oral dose of MK-8931 40mg. If~     any healthy participants from Part I do not meet the matching criteria for Part II additional~     healthy participants will be enrolled.~   "
50127|NCT02910726|"~     This study is being done in patients that have tumors to find out how well sentinel lymph~     nodes (SLNs) can be found with a special dye called indocyanine green (ICG).~   "
50141|NCT02910518|"~     Primary Objective:~      To demonstrate bioequivalence between insulin glulisine given as 300 Units/mL test~     formulation and insulin glulisine 100 Units/mL reference formulation after a single~     subcutaneous (SC) dose.~      Secondary Objectives:~        -  To assess the pharmacodynamic (PD) profiles and further pharmacokinetic (PK)~          characteristics of insulin glulisine U300 in comparison to insulin glulisine U100 after~          a single SC dose.~        -  To assess safety and tolerability of the test and the reference formulation of insulin~          glulisine.~   "
50128|NCT02910700|"~     The goal of this clinical research study is to learn if nivolumab and trametinib (with or~     without dabrafenib) can help to control metastatic melanoma in patients who have a BRAF,~     NRAS, or BRAF-wild-type mutation.~      This is an investigational study. Nivolumab, trametinib, and dabrafenib are each FDA approved~     and commercially available for the treatment of melanoma. However, it is considered~     investigational to use these drugs in combination with each other to treat melanoma. The~     study doctor can explain how the study drugs are designed to work.~      Up to 60 participants will be enrolled in this study. All will take part at MD Anderson.~   "
50129|NCT02910687|"~     In the FINE 75+ study, 307 Non ST Elevation Myocardial Infarction (NSTEMI) patients, 75 years~     old or older, were included between September 2009 and June 2010. The purpose of this~     observational study (FINE75+5) is to describe these patients, especially regarding the~     following variables: cardiovascular risk, co-morbidity and frailty, and to assess the~     prognostic value of frailty on 5-year outcomes. We hypothesize that frailty is independently~     associated with 5-year mortality.~   "
50130|NCT02910661|"~     The overall goal of the Teen Adherence in KidnEy transplant Improving Tracking TO Optimize~     Outcomes (TAKE-IT TOO) study is to adapt the successful TAKE-IT intervention, aimed at~     improving medication adherence in adolescent kidney transplant, for use in 'real world'~     clinical care. The specific aims of Stage 1 of this study are: (1) To understand the needs~     and preferences of stakeholders (kidney transplant recipients, parents, and healthcare~     professionals (HCP)) in order to optimize the TAKE-IT intervention for 'real world' use.~   "
50131|NCT02910648|"~     This research is being done to study the impacts of a computerized learning task on health~     behaviors. The investigators are interested in studying whether this computerized learning~     task can help with weight loss.~   "
50132|NCT02910635|"~     The primary objective of this study is to assess the corrected QT interval (QTc) effect of~     volanesorsen (ISIS 304801) administered as a 300 mg subcutaneous (SC) therapeutic and a 300~     mg intravenous (IV; 2-hour infusion) supra-therapeutic dose relative to placebo in healthy~     adult male and female subjects.~   "
50133|NCT02910622|"~     The choice of treatments for cancers by systemic way - chemotherapy, hormone therapy and~     targeted therapies - is currently defined by criteria for population groups and not to an~     individual. These expensive treatments - in financial terms and quality of life - will be~     effective for some and administered unnecessarily for other because there is no predictive~     test of response for a given individual.~      For breast cancer, the usual treatment includes the first surgery and adjuvant therapies~     (chemotherapy, hormonal therapy ...) whose effectiveness will be assessed after many years as~     the occurrence or not of a recurrence or metastases.~      These systemic treatments can also be administered before surgery to reduce the tumor volume~     and secondarily allow less mutilating surgery: it is the principle of treatment neo adjuvant.~     In this case, the efficiency will be evaluated more quickly.~      In practice, a patient with breast cancer suspicion has a biopsy which confirms the diagnosis~     and defined the parameters (hormone receptors, cytological grade, receptor monoclonal~     antibodies ...) that guide to the most appropriate type of treatment.~      Tumor size is evaluated in neo adjuvant pre-treatment by imaging: mammography, ultrasound and~     MRI.~      At the end of this medication, the evaluation of the response is achieved by radiology and~     surgery.~      Pathological examination evaluates and precise response by the criteria of Chevallier and /~     or Sataloff. An ex vivo test for predicting the response of cells to different chemotherapy~     regimens, the oncogramme, was developed by Oncomedics, a young company whose technology is~     derived from the University of Limoges.~      Clinical response and / or histopathological could be compared in a reasonable time (2-6~     months), the results of the oncogramme proposed by Oncomedics whether the efficiency obtained~     in vivo is that predicted by the ex vivo test.~      It is the same in the metastatic setting when there is an available target for biopsy and~     assessment of response.~      The management of ovarian cancer in advanced stages can also benefit from a radiological and~     histopathological evaluation strategy before and after systemic treatment to compare the in~     vivo results with those predicted by ex vivo by Oncomedics.~   "
50134|NCT02910609|"~     The three options for the treatment of patent ductus arterioles (PDA) in preterm infants are~     conservative approach, pharmacological intervention and surgical ligation. There is not any~     randomized-controlled trial that demonstrates the superiority of these approaches in preterm~     infants.~   "
50135|NCT02910596|"~     Compare the effectiveness of bethanechol chloride and early bladder training for prevention~     of bladder dysfunction after radical hysterectomy in cervical cancer stage IB - IIA.~   "
50136|NCT02910583|"~     This is a multicenter, 2-cohort Phase 2 study assessing both MRD-guided discontinuation and~     fixed duration therapy with the combination of ibrutinib + venetoclax in subjects with~     treatment-naïve CLL or SLL~   "
50137|NCT02910570|"~     This is sub-study to a randomised, double blind, placebo-controlled, parallel group, and~     single-centre trial investigating the effect of liraglutide on body weight and pain in~     overweight or obese patients with knee osteoarthritis (NCT02905864).~      In the parent trial patients will be subjected to a run-in diet intervention phase (week -8~     to 0) including a low-calorie diet and dietetic counselling. At week 0 patients will be~     randomised to receive either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to~     dietetic guidance on re-introducing regular foods and a focus on continued motivation to~     engage in a healthy lifestyle.~      This sub-study of the parent trial only involves an additional assessment of skin auto~     fluorescence (AGE concentration) in the preallocation phase and in the main trial phase, i.e.~     from enrollment (defined as signature of informed consent) to treatment allocation (visits~     -Tx and T0 in the parent trial visit schedule) and from allocation to end of trial (visits T0~     and T15 in the parent trial visit schedule).~   "
50138|NCT02910557|"~     A Postmarketing Prospective Cohort Study of Melanoma Patients Treated With IMLYGIC®~     (Talimogene Laherparepvec) in Clinical Practice to Characterize the Risk of Herpetic~     Infection Among Patients, Close Contacts, and Health Care Providers; and Long-term Safety in~     Treated Patients~   "
50139|NCT02910544|"~     This is a substudy to a randomised trial investigating the effect of liraglutide on body~     weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864). In~     the parent trial, patients will be subjected to an 8-week diet intervention phase including a~     low-calorie diet and dietetic counselling, after which.they will be randomised to receive~     either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on~     re-introducing regular foods and a focus on continued motivation to engage in a healthy~     lifestyle.~      This substudy aims to investigate any changes in physical activity associated with the~     initial 8-week weight loss intervention.~   "
50140|NCT02910531|"~     This study evaluates how daily alpha lipoic acid supplementation affects cystine kidney stone~     recurrence. Half of the subjects will receive 1200 mg alpha lipoic acid orally daily for~     three years, while the other half will receive a placebo. The funding source for this~     clinical trial is FDA OOPD.~   "
50142|NCT02910505|"~     Single center study to evaluate the safety and efficacy of an investigational version of the~     Cutera enlightenTM laser that offers multiple wavelengths for tattoo removal.~   "
50144|NCT02910479|"~     E-Celsius device used for measuring the gastrointestinal temperature is composed of an~     ingestible capsule measuring the temperature as well as a transportable module receiving data~     from the capsule. This device allows to measure the body temperature (± 0.2 ° C) during~     transit of the pill in the digestive tract to a maximum sampling frequency of 30 seconds. The~     main risks related to such devices are related to biocompatibility (in materials used for the~     capsule shell, or level of contamination of the gastrointestinal environment due to a defect~     in the plastic envelope the pill or a lack of hygiene, previously tested in clinical trials;~     see section 10.2).~      It will compare conventional methods of estimating the central temperature continuously with~     gastrointestinal data obtained from the e-Celsius device. The main objective of the research~     is to validate the extent of gastrointestinal temperature obtained from the device under test~     consists of an ingestible electronic capsule and a data reception monitor.~      Secondary objectives will be pursued:~        -  Assess the effects of ingestion of cold drinks on temperature readings taken via~          e-device Celsius, esophageal probe and a rectal probe.~        -  Explore the thermal homogeneity of the digestive tract.~        -  Evaluate the internal memory of the capsule and its data forwarding capacity. This~          protocol will also measure the reliability of the measurement system while comparing it~          to the standards used by health staff today.~   "
50145|NCT02910466|"~     Chronic hypoparathyroidism is a life-long and irreversible disease for which the chronic~     administration of rhPTH(1-84) is a potential treatment option. The group of participants in~     the AAAE0544 core study has been taking rhPTH(1-84) for the treatment of hypoparathyroidism~     for up to 11 years. This study is designed to extend this experience and gain knowledge about~     how safe and effective rhPTH(1-84) is in participants with hypoparathyroidism over a~     long-term duration.~   "
50146|NCT02910453|"~     The standard operative approach to pulmonary lesions has been via postero-lateral thoracotomy~     and direct vision. This technique has some advantages but its morbidity is significant. Some~     surgeons advocate a resection by video-assisted thoracic surgery (VATS) to reduce the impact~     on chest wall and the impairment on respiratory mechanic. However, an evidence for~     superiority of the approach minimally invasive is lacking, particularly for the difficult~     assessment of the change in pulmonary function. The aim of this study is to compare VATS-~     over open lobectomy regarding the differences of chest wall kinematic, analyzed by~     optoelectronic plethysmography (OEP).~   "
50147|NCT02910440|"~     The primary objective of this study is to compare the efficacy of DCL-101 to GoLYTELY in~     preparing the large bowel for colonoscopy. Additional secondary objectives will compare the~     safety of DCL-101 to GoLYTELY in preparing the large bowel for colonoscopy and compare the~     tolerability of DCL-101 to GoLYTELY in preparing the large bowel for colonoscopy.~   "
50148|NCT02910427|"~     Cerebrovascular disease is the second leading cause of death in Taiwan. Although stroke~     incidence and mortality decline steadily in Taiwan, its impact on medical cost, quality of~     life and neurological deficits remains extraordinary. Stroke incidence and mortality are also~     rising in the developed countries presumably due to a world-wide increase in prevalence of~     obesity and metabolic syndrome. Negative associations have been observed between high blood~     pressure, hyperglycemia and two major dietary cations in vegetables and dairy products:~     potassium and magnesium. Mean levels of dietary potassium and magnesium intake in Taiwan are~     much lower than those of dietary reference intake. Short term supplementation studies have~     demonstrated their effects in reducing blood pressure and degree of insulin resistance.~     However, long-term studies on cardiovascular events are lacking. Our previous long-term~     intervention trial in elderly veteran home showed a 41% reduction in cardiovascular mortality~     by simply switching regular cooking salt to potassium-enriched salt in kitchens. The~     investigators have previously observed an annual reduction of medical cost around $ 15,000 NT~     in the aforementioned veteran home trial. A multi-centered randomized controlled trial was~     carried out with three arms: (1) regular salt (Na salt), (2) potassium-enriched salt (K~     salt), and (3) potassium and magnesium-enriched salt (K/Mg salt). The objectives of this~     study was to investigate whether potassium and magnesium-enriched salt would improve the~     neurological performance of the stroke patients.The investigators anticipate to observe~     beneficial effect from consuming potassium and magnesium enriched salt for neurological~     improvement in stroke patients.~   "
50149|NCT02910414|"~     The TARGET BP I Trial is a randomized, double-blinded, multi-center, international,~     sham-procedure controlled trial, comparing renal denervation performed with the Peregrine~     System Kit in the treatment group to the sham control group (without renal denervation - no~     alcohol infusion). Subjects will be randomized in a 2:1 fashion to treatment versus sham~     control via central randomization.~   "
50150|NCT02910401|"~     Rhinovirus (RV) infections represent the most common cause of asthma exacerbations in~     children and adolescents. The investigators hypothesize that the immune responses generated~     in the nose of allergic rhinitics and asthmatics underlie subsequent systemic modulation of~     the immune system, and that - in susceptible individuals (i.e., those with pre-existing~     asthma) - this modified nasal milieu is responsible for the asthma exacerbation.~      Open label single center study in asthmatics as well as allergic rhinitis (AR) and healthy~     controls. All subjects will undergo good manufacturing practice (GMP) RV16 inoculation and~     responses will be compared between the 3 cohorts.~   "
50151|NCT02910388|"~     To assess the benefits of large Loop excision of the transformation Zone (LLETZ) under direct~     colposcopic Vision.~   "
50152|NCT02910375|"~     This retrospective multi-centric Belgian prospective trial will involve 10 patients~     initiating or under maintenance subcutaneous golimumab therapy for moderate-to-severe colitis~     at the University Hospitals Leuven (Leuven, Belgium) or AZ Groeninge (Kortrijk, Belgium)~      Patients will (have) receive(d) standard induction therapy with golimumab 200mg at week 0,~     and golimumab 100mg at week 2. Maintenance therapy will (have) start(ed) at week 6, with 50~     or 100mg of golimumab every 4 weeks, depending on body weight (50mg every 4 weeks for~     patients with a body weight of less than 80kg, and 100mg for the others)~      Patients will come to the hospital for clinical evaluation, blood sampling and golimumab~     administration following daily clinical practice. The patients will be requested to perform~     several dry blood spot analyses at home.~   "
50335|NCT02907996|"~     The objectives of this study are to collect and assess data related to safety and~     effectiveness of Sovaldi treatment regimens, per the approved prescribing information for~     Sovaldi, in routine clinical practice and report results to Korean Ministry of Food and Drug~     Safety (MFDS).~   "
50153|NCT02910362|"~     This study will measure the dynamic real-time intraocular pressure (IOP) in the anterior~     chamber during standard phacoemulsification surgery.~      What is known:~        -  Fluidics control is determined to be one of the primary drivers of physician decision~          making in choosing phacoemulsification equipment.~        -  Active pressure system fluidic control has a perceived and possibly real (based upon~          recent literature) improvement in intra-cameral IOP stability and reduced pressure~          fluctuations.~        -  Improved fluidics can allow for reduced dynamic IOP fluctuations, in-the-bag positioned~          phaco tip, and intra-cameral fluid flow all of which will likely improve corneal health~          post-operatively.~   "
50154|NCT02910349|"~     Severe aortic regurgitation is a common valvular heart disease with prevalence of~     approximately 1%, affecting rather younger patients. The surgical treatment is the only~     causal treatment; it is recommended in patients with severe symptomatic aortic regurgitation.~     The optimal timing of the surgery is crucial because there is a certain risk of perioperative~     mortality and most patients require lifelong anticoagulation therapy. It is widely accepted,~     that asymptomatic patients with severely dilated left ventricle with systolic impairment have~     worse postoperative prognosis. We aim to evaluate native myocardial T1 relaxation time~     derived from cardiac magnetic resonance and global longitudinal left ventricular strain~     measured by echocardiography. These parameters are related to diffuse myocardial fibrosis and~     we expect to identify the cut off values, which correlate with further clinical course. This~     might enable better timing of the surgical treatment with the optimal postoperative left~     ventricular reverse remodelling and improved patient prognosis.~   "
50155|NCT02910336|"~     Orofacial pain, specially neuropathic orofacial pain, is a challenge of diagnosis and~     treatment in orofacial pain. It is associated with sensory abnormalities.With increasing life~     expectancy of the population is more and more common to find individuals with chronic~     diseases however, there is little evidence about the influence of comorbidities and~     medications in use on sensory thresholds of neuropathic orofacial pain. Objective: to~     investigate the influence of comorbidities and medication in somatosensory function of~     patients with orofacial neuropathic pain compared to controls.In this case-control study, 336~     orofacial pain patients and controls were recruited from the Hospital das Clinicas da~     Faculdade de Medicina da USP were investigated about comorbidities, use of chronic~     medication, pain characteristics and a detailed standardized protocol of somatosensory~     evaluation at the trigeminal territories for cold, warm, tactile, vibration, deep,~     superficial and electric pain thresholds.~   "
50156|NCT02910323|"~     The Will Erwin Headache Research Center Study of Cluster Headache and Trigeminal Neuralgia is~     a prospective, multicenter, observational research network for subjects with Cluster Headache~     and/or Trigeminal Neuralgia.~   "
50157|NCT02910310|"~     This study is a prospective, systematic evaluation to assess the effectiveness and safety of~     introduction of UBT into PPH care at secondary level and district hospitals in 3 low-resource~     countries. The first component of the evaluation is a prospective stepped wedge cluster~     randomized design to assess the potential reduction in PPH-related mortality and invasive~     procedures (blood transfusion, arterial ligation, hysterectomy and uterine arterial~     embolization) for PPH performed at participating facilities following introduction of UBT.~     The second component is a nested cohort analysis to assess the safety and acceptability of~     UBT among women diagnosed with PPH.~   "
50158|NCT02910297|"~     The purpose of this study is to determine if cannabidiol (CBD) obtained via the state of~     Minnesota reduces seizures in patients with severe intractable epilepsy (Dravet Syndrome or~     Lennox Gastaut Syndrome), and to measure blood levels of CBD to help determine CBD~     concentration-response characteristics.~   "
50159|NCT02910284|"~     This study is a follow-up study from Study GEN-003-002 to evaluate long-term efficacy and~     immunogenicity of GEN-003 in subjects with genital HSV-2 infection.~   "
50160|NCT02910271|"~     AIMS: Determining the clinical features and prevalence of peripheral artery disease (PAD) in~     asymptomatics patients with type 1 diabetes mellitus (T1DM) and checking the validity of the~     current recommendations regarding for PAD screening in T1DM.~      METHODOLOGY: An observational and cross-sectional prevalence study. The whole group of~     patients (sample size calculated: 299 patients) will make the Edinburgh Questionnaire for~     detecting classic symptoms of intermittent claudication, and after verifying the absence of~     symptoms and exclusion criteria, they will be included in the study. All patients will~     undergo assessment of clinical parameters related to T1DM and classic cardiovascular risk~     factors, as well as, an analytical assessment of the lipid profile, HbA1c level,~     proinflammatory profile and oxidative stress status. They will also undergo a comprehensive~     anthropometric assessment including office blood pressure (BP) monitoring and ambulatory~     24-hours BP monitoring in patients with an indication as routine clinical practice,~     assessment of cardioautonomic function, and lastly an ankle-brachial index (ABI) by Doppler~     ultrasound, in the context of routine clinical practice in patients with clinical indication,~     or as an extraordinary procedure for participating in the study in patients who do not meet~     criteria for screening according to current recommendations.~   "
50161|NCT02910258|"~     Patients who carried primary or secondary myelofibrosis from Philadelphia negative MPNs~     (PMF/SMF) and who are treated or are about to be treated with pegylated-interferon (mostly~     α2a) are eligible to this prospective study. Biological and clinical parameters will be~     collected from the beginning of the drug use until last news.~      A non-opposition consent form need to be signed before entering this study.~   "
50162|NCT02910245|"~     This project is a double-blind, randomized, placebo-controlled, multicenter trial in the~     Netherlands. The aim of this study is to investigate the therapeutic efficacy of optimized~     6-mercaptopurine (6-MP) in ulcerative colitis patients. Therapeutic drug monitoring (TDM)~     will be performed in order to optimize treatment outcomes and objective endoscopic endpoints~     will be used.~   "
50163|NCT02910232|"~     Biodegradable scaffold is an accepted and commercialized medical alternative choice for bone~     regeneration. In this project we will used our new invention, porous starch- hydroxyapatite~     composite, for in vivo clinical trial.~   "
50164|NCT02910219|"~     Chemotherapy induced diarrhea is seen in up to 40-80% of patients receiving this treatment~     for HER2 positive locally advanced or metastatic breast cancer. This diarrhea can~     significantly impact a patient's quality of life and ability to tolerate chemo/anti-HER2~     therapy. This study will look at the efficacy of the drug crofelemer in preventing diarrhea~     in breast cancer patients.~   "
50165|NCT02910206|"~     Elderly patients have high mortality and postoperative complications rate after surgery,~     especially postoperative cardiac complications. A meta-analysis revealed haemodynamic~     intraoperative events significantly increased the risk of postoperative cardiac~     complications.To limit the risk, optimize the intraoperative management of circulation is~     essential. Anesthetic drug may effect on the haemodynamic intraoperative, reduction of~     postoperative complications should aimed at choosing the optimal anesthetic drug with minimal~     effect on haemodynamic.So this study is to explore the comparative efficacy and safety of~     anesthetic drug (etomidate or propofol) in elderly patients~   "
50166|NCT02910193|"~     The goal of the multicenter subproject (SP) 10 of the eMED Alcohol Addiction Consortium - A~     Systems-Oriented Approach is to study neuroimaging x genetics predictions in an existing~     sample (NGFNplus) of tightly endophenotyped and genome-wide genotyped alcohol dependent~     subjects (N=240) and controls (N=240); (ii) to translate the results of neuroimaging and~     genetic analyses from an adolescent risk sample (IMAGEN) to adult disease (NGFNplus sample)~     by examining related MRI-paradigms tagging the same functional brain systems in both samples~     (e.g. reward system, inhibitory control system, emotion processing, working memory); (iii) to~     conduct a follow-up neuroimaging study on the NGFNplus sample validating the neurobehavioral~     risk profiles predictive for juvenile harmful alcohol use in adult patients with alcohol~     addiction, (iv) to expand the NGFNplus sample by including a new set of healthy subjects with~     high genetic risk (1st degree relatives of patients with alcohol addiction). The~     investigators will do so by using elaborate imaging genetic methods that are already~     available and successfully used in other multicenter studies by the investigator's research~     group (e.g. univariate analyses, functional and effective connectivity analyses, polygenetic~     scores, network topology) as well as by using complex computational algorithms and~     mathematical models, in particular advanced machine learning methods, developed in SP 6. The~     investigator's approach aims in the long to predict and characterize longitudinal outcomes in~     patients with alcohol addiction (5 years following our index session) and to complement the~     NGFN-sample with an add-on study with 1st degree relatives that will allow the investigators~     to test the generalizability of the identified predictive risk profiles for early risk~     identification.~   "
50167|NCT02910180|"~     This study encompasses the maintenance and utilization of a repository of samples from~     patients with cerebrovascular disease and stroke. The types of tissue taken are blood,~     cerebrospinal fluid (CSF), tissue, and microdialysis samples. Future analysis of these~     samples can potentially help investigators to better categorize groups of patients,~     understand the underlying etiology of these pathologies, identify markers that are associated~     with favorable or poor outcomes, and track changes that occur during the natural course of~     the disease or with treatment. This is a prospective observational study which will use~     samples from such patients to create this library which can be used to explore these~     questions in the future.~   "
50168|NCT02910167|"~     What AE occur in routine clinical practice, what is the incidence of AE and ADR, how many~     patients present with AE symptoms related to a potential liver injury. What are the drug~     utilization patterns in patients, what are the predisposing factors for the occurrence of~     adverse events and adverse drug reactions.~   "
50169|NCT02910154|"~     Angina is the most common symptom of coronary heart disease among women but unlike men most~     women do not have stenosis of the coronary arteries. In a large proportion of these women,~     coronary microvascular dysfunction (CMD) is thought to be the cause of angina. However, CMD~     is also demonstrable in the asymptomatic population, and may merely be an innocent bystander~     related to the presence of cardiovascular risk factors rather than a cause of angina~     symptoms.~      The aim of this study is to determine whether comprehensive intervention is feasible and~     results in improvement in both angina and microvascular function in these patients.~   "
50170|NCT02910141|"~     This study aims to compare glycaemic control during continuous subcutaneous insulin fusion~     (CSII, insulin pump therapy) and multiple daily insulin injections in type 2 diabetes and to~     identify patient-level characteristics that predict the best improvement in control and any~     change in insulin dose or other outcome.~   "
50171|NCT02910128|"~     This study evaluates the effect of the education innovation programchiquichefs on~     anthropometric variables, quality of life and nutritional habits in an elementary school~     children. Compared with a control group of the same age but in another school.~   "
50172|NCT02910115|"~     The objective of the study is to demonstrate whether cooling the uterine smooth muscle during~     cesarean section (following delivery of the fetus) will promote better uterine contraction~     and involution resulting in lower blood loss, use of fewer uterotonic medications, and fewer~     hysterectomies following cesarean section for dysfunctional labor.~   "
50173|NCT02910102|"~     This study seeks to evaluate the effect of intepirdine (RVT-101) on gait and balance in~     patients with Alzheimer's Disease, Dementia with Lewy Bodies or Parkinson's Disease Dementia.~   "
50174|NCT02910089|"~     The purpose of this study is to evaluate whether a combination of pharmacist-delivered~     patient engagement techniques improves disease control and medication adherence among~     patients with poorly-controlled diabetes compared with usual care. These engagement~     techniques include shared decision-making and brief negotiated interviewing and are delivered~     telephonically.~   "
50175|NCT02910076|"~     Antimalarials such as hydroxychloroquine (HCQ), are among the oldest prescribed drugs still~     used in clinical practice. Relatively inexpensive and well tolerated, these drugs have been~     recognized to be effective in autoimmune diseases such as rheumatoid arthritis (RA) and~     systemic lupus erythematosus (SLE). Interestingly, there is growing evidence of their~     beneficial impact on cardiovascular risk, particularly diabetes. HCQ therapy can improve~     balance in patients with unbalanced diabetes. This drug therapy may be a new therapeutic~     approach for diabetes. There is need for a better understanding of the mechanisms responsible~     for the improvement of the metabolic response to drug treatment. The investigators~     hypothesize that treatment with a drug improves the function of the beta cell and its ability~     to secrete insulin in response to glucose. The investigators will examine the impact of~     short-term therapy for HCQ in beta cell function in healthy volunteers and in patients with~     type 2 diabetes.~   "
50407|NCT02907047|"~     The purpose of this study is to correlate functional outcomes and perioperative complications~     with tourniquet use during total knee arthroplasty.~   "
50408|NCT02907034|"~     Financials constraints of health systems require suitable indices and criteria to better~     allocate resources in order to enhance and maximize social welfare. Among multiple methods,~     the quality-adjusted life year (QALY) is used as a validated and preference-base measure for~     health care procedures in health economics studies such as cost-utility analyses.~      In France, the methodological guide of the public agency of the High Authority for Health~     (HAS) recommends the valuation of health states with the use of a generic and descriptive~     instrument (EQ5D), validated by the Time Trade Off method (TTO) in samples from general~     French population.~      Although it appears to be legitimate to distribute collective resources based on general~     population preferences, a major concern is that individuals do not face a real choice that~     can have a direct implication on their welfare and their life.~      The existence of a discrepancy between revealed hypothetical preferences and real~     preferences would raise the problem concerning production of the currently available~     standards and norms. Hence, a methodological deepening of these preferences revelation~     process is necessary.~      Virtual reality (VR) could play a key role in resolving this methodological problem. Widely~     used in the field of health (such as therapy, medical training...), VR is a simulation that~     seeks to approach the reality, without trying to be quite like it. It aims one or more~     individuals to explore a sensorimotor and cognitive activity in an artificial world in 3D,~     which can be imaginary, symbolic or a simulation of some aspects of the real world (Fuchs,~     2006). VR could be well applied to the field of health economics by offering hypothetical~     scenarios of the different health states from the EQ5D that individuals might experience in~     the first person.~      To date, existence of this discrepancy between revealed hypothetical preferences and actual~     preferences of individuals from the general population is extremely difficult to explore.~     However, this is an important methodological challenge in the revelation of preferences to~     guide health-related decisions.~      Indeed, comparing the revealed preferences about health states established from a first~     person experience in VR to the revealed preferences established from the classic narrative~     approach without VR, may provide an accurate approach of actual and real preferences of~     individuals from the general population.~      Moreover, another advantage of VR is to permit the assessment of a greater number of health~     states, this method being faster processed than the narrative approach: individuals are~     experimenting immediate experience of a situation when under VR. Thus, VR method may overcome~     technical constraints of the classic narrative approach concerning limited sample sizes in~     norms production.~      To the investigators knowledge, VR has never been proposed for valuating health conditions.~      This study would report the relevance and interest in using VR (immersive and immediate life~     situation experience) for the production of utility EQ5D health states values in the general~     population by the revelation of preferences method called the Time Trade Off (TTO), the~     currently approach recommended by the HAS.~      Using VR could circumvent some limitations of the current narrative approach: it would~     provide a better feasibility and acceptability among subjects, fewer inconsistencies, an~     easier and wider access to disadvantaged individuals. Eventually revisions of available~     standards could be proposed to allow the HAS and policy makers to base their choices on more~     reliable, standardized and accurate classifications of health states conditions, that~     associate each health state to a predefined value.~   "
59160|NCT02792504|"~     To evaluate safety and efficacy of CE/BZA in real practice in Korea~   "
50176|NCT02910063|"~     This is a phase 2/3 open label, multicenter trial testing blinatumomab monotherapy for the~     treatment of subjects with Relapsed/Refractory (R/R) aggressive B-NHL not achieving CMR after~     2 cycles of standard platinum-based chemotherapy regimens administered as S1. This study~     incorporates multiple interim analyses for futility, efficacy, and unblinded sample-size~     re-estimation. In the phase 3 part of the study, blinatumomab will be compared to~     Investigator's Choice chemotherapy.~   "
50177|NCT02910050|"~     This study is aim to evaluate the efficacy and safety of bicalutamide and aromatase inhibitor~     in ER(+)/AR(+)/HER2(-) metastatic breast cancer patients who have disease progression after~     treatment of an aromatase inhibitor.~   "
50178|NCT02910037|"~     This study aims to use a clinically validated metagenomic next-generation sequencing (mNGS)~     assay to provide a demonstration of precision medicine for diagnosis of acute infectious~     disease in hospitalized patients. From June 2016 to June 2017, 200 patients will be enrolled~     from multiple hospitals in California and outside of California. Patients will be evaluated~     to determine the impact on the mNGS assay on diagnostic yield, hospital costs and clinical~     outcomes.~   "
50179|NCT02910024|"~     The present prospective, randomized, controlled, double-blinded trial investigates the~     effects of intermittent theta-burst stimulation (iTBS) during the early rehabilitation after~     stroke. Patients with hemipresis will receive either sham or real iTBS over their affected~     hemispheres before occupational therapy for 8 days. Motor recovery is assessed one day after~     the intervention phase and three months after enrollment.~   "
50180|NCT02910011|"~     This study will investigate the safety and clinical efficacy of a novel doxycycline topical~     formulation in subjects with Atopic Dermatitis (AD). The investigators hypothesize that daily~     application of the study drug in AD subjects will reduce severity of the disease, by reducing~     skin driven inflammation and restoring skin barrier function. The investigators will also~     monitor the anti-microbial activity of this product on AD skin, as colonization with Staph~     aureus is typically associated with disease severity.~   "
50181|NCT02909998|"~     Use of genotyping for the optimization of treatment with biologics in chronic arthritis by~     looking for an association between certain alleles and response to treatment.~   "
50182|NCT02909985|"~     This pilot study will evaluate the visual response to infrared (IR) in humans after dark~     adaptation. The investigators plan to determine which wavelength and intensity the human eye~     is most sensitive too, using a broad spectrum light source and wavelength-specific bandpass~     filters. The investigators will then evaluate the electrophysiologic response in healthy~     humans to IR, followed by studies in those with specific retinal diseases.~      The long-term goal of this research is to better understand the role that IR plays in visual~     function, and whether this can be manipulated to allow for vision in certain retinal~     pathologies that result from loss of photoreceptor cells. The investigators central objective~     is to test the electrophysiologic response to IR in the dark-adapted retinal and visual~     pathways. The investigators central hypothesis is that IR evokes a visual response in humans~     after dark adaptation, and the characteristics of this response suggest transient receptor~     potential (TRP) channel involvement. The investigators rationale is that a better~     understanding of how IR impacts vision may allow for an alternative mechanism for vision in a~     number of diseases that cause blindness from the degradation or loss of function of~     photoreceptor cells. The investigators will test the investigators hypothesis with the~     following Aims:~      Aim 1: To determine the optimal IR wavelength for visual perception in dark-adapted human~     participants. The investigators hypothesize that the healthy human eye will detect IR~     irradiation, with a maximum sensitivity at a specific wavelength. Using a broad-spectrum~     light source with wavelength-specific bandpass filters, the spectral range of visual~     perception to IR will be evaluated. The same will be done on colorblind participants.~      Aim 2: To test the electrophysiologic response to IR in healthy humans after dark adaptation.~     The investigators hypothesize that IR will elicit an amplitude change on electroretinography~     (ERG) and visual evoked potential (VEP) responses after dark adaptation in healthy human~     participants. Participants will be tested with both test modalities to evaluate their~     response to IR.~      Aim 3: To test the electrophysiologic response to IR after dark adaptation in humans with~     certain retinal diseases. Participants with retinitis pigmentosa, age related macular~     degeneration and congenital stationary night blindness, will be tested. Results will be~     compared to baselines and to those of healthy participants. The investigators hypothesize~     that there will be a response to IR on ERG and VEP, which will provide clues to the retinal~     cell layer location of the response to IR and the nature of potential TRP channel~     involvement.~   "
50183|NCT02909972|"~     Phase I, open label, multi-center dose escalation (DEP) and dose expansion (EXP) study~     designed to evaluate safety, tolerability, PK (pharmacokinetics), PD (pharmacodynamics) and~     anti-tumor effects of ALRN-6924 in patients with acute myeloid leukemia or advanced~     myelodysplastic syndrome with wild-type (WT) TP53.~   "
50184|NCT02909959|"~     The aim of this randomized controlled trial is to determine if a nutritional supplement~     containing broccoli sprout and seed extracts, a rich source of sulforaphane, is effective in~     reducing core symptoms of autism spectrum disorder (ASD). The study will also explore the~     safety and tolerability of a sulforaphane supplement in young men with ASD, as well as its~     effects on challenging neuropsychiatric symptoms that are commonly associated with ASD, such~     as hyperactivity, irritability, and repetitive movements.~   "
50185|NCT02909946|"~     Multidrug-resistant organisms (MDROs) are endemic in nursing homes (NHs) with prevalence~     rates surpassing those in hospitals. The aim of the study is to design and evaluate the~     effectiveness of a multi-component intervention to reduce new acquisition of MDROs in NH~     residents. The intervention will incorporate resident-level, environmental, and caregiver~     based strategies. Using a cluster-randomized study design, three NHs will be randomized to~     the intervention group and three to the control group. Control NHs will be allowed to~     continue standard infection prevention practices. Nursing homes will serve as the unit of~     allocation. Analyses will be performed both at the resident and the cluster level. The~     primary outcomes of the study are reduction in MDRO prevalence, and reduction in new MDRO~     acquisition .~   "
50186|NCT02909933|"~     Weight reduction is the most important treatment target when polycystic ovary syndrome (PCOS)~     is linked to obesity. Liraglutide (LIRA) in dose of 3 mg was recently approved as an~     anti-obesity drug. Metformin could enhance weight lowering potential of liraglutide.~      We investigates short term interventions with low dose liraglutide in combination with~     metformin and high dose liraglutide alone influence on significant weight reduction in obese~     women with PCOS.~   "
50187|NCT02909920|"~     Shoulder pain is a common and high prevalence in the general population. Subacromial Syndrome~     (Shoulder Impingement Syndrome (SIS)) is the most frequent cause. SIS patients suffering~     pain, muscle weakness and loss of movement in the affected joint. Initial treatment of the~     SIS is predominantly conservative. Surgical option has high success rates and is often used~     when conservative strategy fails. Traditional Physiotherapy and Postoperative exercises is~     needed to the recovery of joint range, muscle strength, stability and functionality. This~     Research evaluates the feasibility and effectiveness of a telerehabilitatión Program in SIS~     after surgery compared with traditional therapy.~   "
50188|NCT02909907|"~     To compare the efficacy of botulinum toxin (BoNT) injections in forearm flexors plus extensor~     muscles versus flexors alone for the treatment of essential hand tremor (ET).~   "
50511|NCT02905682|"~     The purpose of this trial is to demonstrate efficacy of desmopressin ODT against placebo for~     the treatment of female subjects with nocturia due to nocturnal polyuria, during 12 weeks of~     treatment.~   "
50189|NCT02909894|"~     Research shows that sitting for long periods of time on a regular basis is bad for health and~     can leave individuals more susceptible to Obesity, Cardiovascular Disease, Type 2 Diabetes~     and premature death regardless of exercise engagement outside of these seated hours.~      As sitting is so common in modern society it is vital that research explores ways to protect~     individuals from this worsening issue. Investigators want to see if breaking up long periods~     of sitting time with short, frequent bouts of light physical activity, while remaining~     seated, is enough to alleviate these risk factors.~   "
50190|NCT02909881|"~     PhytoSpherix (Phx) is an all-natural, edible polysaccharide extracted from sweet corn. This~     carbohydrate is the major muscle fuel for intense exercise and its stores are quite small~     such that one can run out of it during a single exercise bout. Therefore, Phx should provide~     significant exercise fuel if consumed during exercise. As a result its intake could enhance~     intense exercise performance by providing additional fuel. This experiment Will investigate~     the effects of 4 different dosages of Phx consumed throughout a prolonged exercise bout on~     carbohydrate and fat utilization as well as its oxidation rate and perception of effort~     during prolonged intense exercise in trained cyclists. Muscle and liver carbohydrate stores~     will be examined using a non-invasive ultrasound technique.~   "
50191|NCT02909868|"~     The position of the RV lead may have an important role in the effectiveness of the~     Programmable Hypertension Control (PHC) therapy by the Moderato pacemaker eliciting a lag~     from which RV signals (QRS) are identified.~      The study attempts to measure RV Pressure and RV Volume with PHC in two RV lead locations.~   "
50192|NCT02909855|"~     This study investigates whether there are psychological predictors of parental perception of~     side-effects following vaccination with the child flu vaccine. We will also investigate~     whether the perception of side-effects affects parents' intention to vaccinate their child~     again in the following flu season, as well as whether there are underlying differences in~     parents' cognitive biases between those who do and do not re-vaccinate their child.~   "
50193|NCT02909842|"~     This blinded randomized controlled trial aims to investigate the effect of drinking fermented~     milk containing Lactobacillus paracasei (IMULUS) on immune response against influenza.~   "
50194|NCT02909829|"~     Despite current treatments for type 1 diabetes, maintaining blood glucose levels within a~     good range is a difficult task. A primary source for poor glucose control in adolescents is~     skipping insulin boluses at mealtimes. Advances in glucose sensors have motivated the~     research towards closed-loop delivery systems to automatically regulate glucose levels.~     Closed-loop delivery (artificial pancreas) is composed of an insulin pump, a continuous~     glucose sensor and a dosing algorithm that calculates the insulin dose to infuse based on~     sensor readings. The performance of a closed-loop delivery after a missed bolus may be~     improved if the computer program that calculates the insulin is enhanced with a meal~     detection module. The meal detection module will automatically detect the meal (which had no~     bolus delivered), and signal the delivery of more insulin.~      The aim of this study is to assess the safety and efficacy of a closed-loop delivery with and~     without meal detection module compared to conventional pump therapy in regulating~     post-prandial glycemic levels after omission of a meal bolus.~      The primary hypothesis is that closed-loop delivery with no meal detection module will reduce~     the mean increase in postprandial glucose levels after a missed bolus compared to~     conventional pump therapy.~   "
50195|NCT02909816|"~     The objective was to assess adverse event risk in the use of Nitrous Oxide for Pediatric~     Dental Patients. The investigators performed a multicenter observational study. The~     investigators included patients aged 1 to 18 years and who have already failed dental care~     because of non-cooperation; they could be with mental or cognitive disabilities and could~     have sedative premedication. The investigators performed any type of dental care With the Use~     of Nitrous Oxide/Oxygen Sedation. The primary outcome was vomiting assessed during or after~     dental care.~   "
50196|NCT02909803|"~     It is not known whether different lentil varieties have the same efficacy in lowering blood~     glucose. Similarly, the carbohydrate component of lentils responsible for lowering blood~     glucose is not known, nor is the bioavailability of lentil metabolites and polyphenol~     bioactive.~   "
50197|NCT02909790|"~     The purpose of this study is to assess the safety and effectiveness of the CURVE Low-Level~     Laser Therapy for circumference reduction of the waistline.~   "
50198|NCT02909777|"~     This research study is evaluating a novel drug called CUDC-907 as a possible treatment for~     resistant (refractory) pediatric solid tumors (including neuroblastoma), lymphoma, or brain~     tumors.~   "
50199|NCT02909764|"~     The goals of the proposed research are to determine whether repeated exposure to a low sodium~     food will result in reduced preference for salt in that food among children; and to determine~     whether such reductions in preference are related to dietary intake of salt, taste receptor~     genotype, and anthropometric and physiological measures.~   "
50200|NCT02909751|"~     The purpose of this study is to investigate whether tocotrienol can improve the effect and~     reduce the side effects of standard chemotherapy before operation for breast cancer.~   "
50201|NCT02909738|"~     The investigators would like to test how well healthy human volunteers power a modified~     oxygen concentrator. The investigators modified the oxygen concentrator to be powered by a~     bicycle instead of wall power so that it can be used in low resource countries where the~     power supply is unreliable.~   "
50202|NCT02909725|"~     Multiple studies have demonstrated a very low prevalence of women meeting physical activity~     and weight gain recommendations during pregnancy. Additionally, previous Blossom Project~     studies have shown that when pregnant women engage in a 20 minute walk each day, they spend~     significantly more time sitting in addition to longer bouts of sitting resulting in increased~     total sedentary time. We are going to test which method works best to decrease sitting time,~     and how those methods effect metabolic parameters such as insulin resistance and blood~     glucose. This study will consist of three groups, each utilizing a commercially available~     fitness tracker, Fitbit. Group 1 (SR): will reduce sedentary time by interrupting prolonged~     sitting. Group 2 (WALK): will reduce sedentary time via walking. Group 3 (UC): will continue~     on with their normal daily routine; usual care.~   "
50423|NCT02906839|"~     The main aim of this project is to assess the effect of Sleep apnea syndrome (SAS) screening~     (and treatment if SAS is moderate to severe, defined by an apnea hypopnea index >15 / h) on~     recurrence of atrial fibrillation (AF) over a twenty-four month follow-up period, in patients~     on optimal medical treatment after AF ablation.~   "
50203|NCT02909712|"~     Sulfadoxine-pyrimethamine (SP) is currently recommended by the World Health Organization for~     use as intermittent preventive treatment against malaria in pregnancy (IPTp) in areas of~     moderate to high malaria transmission. However, in some locales malaria parasites have lost~     sensitivity to SP, compromising its protective effect. Dihydroartemisinin-piperaquine (DP) is~     a candidate replacement for SP. This trial is designed to confirm the cardio-safety of DP~     compared to SP amongst pregnant women in Tanzania.~   "
50204|NCT02909699|"~     This study will investigate how resveratrol (phenol present in red grapes, wine and peanuts)~     can improve heart muscle function and ability of arteries to dilate in response to an~     increase in blood flow in adults 65 years of age and older. Additionally, investigators will~     look at how resveratrol can improve functioning of cells (cellular house-keeping) which can~     be related to cardiovascular function.~   "
50205|NCT02909686|"~     The overall objective of this protocol is to test if Gulf War Illness (GWI) involves chronic~     inflammation that cannot be measured with typical techniques. The investigators will be~     observing the effects of nine different botanical compounds (supplements) that are known to~     suppress inflammation. If one of those supplements helps the symptoms of GWI, it will give~     the investigators information about what is wrong in people with GWI.~   "
50206|NCT02909673|"~     This study is a school-based cluster randomized trial of the 7th grade version of Fourth R, a~     promising teen dating violence prevention program, with 24 ethnically diverse middle schools~     (12 intervention schools, 12 control schools) in one of the nation's largest school~     districts. Students (N = 3,375) will be the unit of analysis and studied prospectively~     (baseline, [post-intervention], and annually for 3 years) to determine the impact of the~     program by comparing students in intervention schools with those in control schools.~   "
50207|NCT02909660|"~     This study evaluates the efficacy and acceptability of two cognitive-behavioural~     interventions for reassurance seeking behaviour in obsessive-compulsive disorder (OCD), a~     family accommodation reduction protocol vs. a novel support-seeking protocol. Half of~     participants will be randomly assigned to participate in the support-seeking intervention,~     whereas the other half will participate in the family accommodation reduction intervention.~   "
50208|NCT02909647|"~     Background: Three dimensional (3D) digital pre-operative planning software for osteosynthesis~     of fractures was developed. To assess the usefulness of the 3D planning, we evaluated the~     accuracy of the reduction shapes and selected implants in the patients with distal radius~     fractures.~      Methods: Thirty wrists of 30 distal radius fracture patients who underwent osteosynthesis~     using volar locking plates were evaluated. Fifteen wrists were treated with 3D preoperative~     planning as the plan group. The other fifteen wrists were treated with conventional~     preoperative planning as the control group. Volar tilt and radial inclination were measured~     after operation and compared with the healthy side wrist. In addition, preoperative planning~     and postoperative reductions were compared by measuring the volar tilt and radial inclination~     of the 3D images in the plan group. The intra-class correlation coefficient (ICC) values of~     the radiological parameters between healthy side wrists and injured side wrists, between~     preoperative planning and postoperative reductions were evaluated. For the accuracy of the~     implant choices, the ICCs for the screw lengths between the preoperative plan and the actual~     choices were evaluated in the plan group.~   "
50209|NCT02909634|"~     Currently, the number of patients having either permanent or temporary stomas placed is~     increasing each year. Yet, patients with ostomy pouches often struggle with predicting when~     stool output will occur and how to plan around dynamic changes in intestinal activity.~     Ostom-I provides a real-time assessment of the volume in the ostomy bag, it does not predict~     when and how fast such output will occur. In this pilot study the investigators aim to gather~     normative AbStats and Ostom-I data in participants with an ostomy to improve prediction of~     stool output.~      Aim 1: To gather normative AbStats and Ostom-I data in subjects with an ostomy to improve~     prediction of stool output.~      Aim 2: Correlate the data from both wearable biosensors and test the predictive validity of~     AbStats in determining ostomy bag filling as measured by Ostom-I.~   "
50210|NCT02909621|"~     This study is a prospective, randomized, double-blind, placebo-controlled with 3~     parallel-groups and multicenter trial in patients suffering from knee OA (osteoarthrosis).~      A first exploratory non comparative study (TILFLEXY002, NCT01909037, Henrotin et al., 2014~     BMC Complementary and Alternative Medicine) evaluated the efficacy of FLEXOFYTOL® at the dose~     of 2x3 caps/day, during a 3-month period, in 22 patients suffering from knee OA, on the serum~     levels of cartilage-specific and inflammatory biomarkers, on the evaluation of pain and on~     the global patient assessment of disease activity.~      This study demonstrated a statistically significant decrease of sColl2-1 cartilage specific~     biomarker, an early decrease of the ultrasensitive C-reactive protein (CRP), an improvement~     of the global assessment of the disease by the patient as well as a good tolerance and~     compliance for the treatment. Results of this exploratory study are encouraging and justify~     the setup of a randomized, placebo-controlled double blind and dose-ranging trial.~   "
50211|NCT02909608|"~     Physical activity is an important factor in understanding how diseases can affect a child.~     Decreases in physical activity are sometimes the first thing that happens before a child is~     diagnosed with a disease. When a child sees their doctor, that visit reflects a single point~     in time. It does not capture how a child feels during the days in between visits to their~     doctor. This study plans to use special monitors called actigraphs to collect information~     about physical activity in children with a type of disease called pulmonary hypertension.~     This study will measure how active these children are and compare their activity to clinical~     information and to actigraphy measurements in children without pulmonary hypertension.~   "
50212|NCT02909595|"~     Endoscopic bile duct stone (BDS) removal is a well-established treatment; however, the~     preference for basket or balloon catheters for extraction is operator-dependent It is~     reported that complete endoscopic treatment with a single catheter is more likely when~     choosing a balloon catheter over a basket catheter for extraction of BDSs≤10mm. However, a~     study comparing the two catheter types in patients with periampullary diverticulum has not~     been performed, and there is no strong basis on which to recommend the balloon catheter as a~     first-line stone removal device. The investigators therefore conducted a multicenter~     prospective randomized trial to compare catheter performance in patients with periampullary~     diverticulum.~   "
53281|NCT02869529|"~     Database of Institut Paoli-Calmettes patients diagnosed with chronic lymphatic leukemia~   "
50216|NCT02909543|"~     This research will focus on young women between the ages of 18-38 who underwent a heart~     operation and their life experiences. This research will focus on these life events and the~     paradigm of these women being raised as heart sick, and consequently lacking self-esteem~     (Frigiola, Bull, & Wray, 2014; Hickey et al., 2012). Most qualitative studies focusing on the~     quality of life compare men and women, completely ignoring women's body image and the~     experience of womanhood (Hickey et al., 2012; Hövels-Gürich et al., 2007; Sarikouch, et al.,~     2013). This study aims to focus on women's stories about their life experiences and the~     influence of surgery(ies) on their daily life using an the qualitative phenomenological~     approach.~   "
50217|NCT02909530|"~     Endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) is a valid and recommended~     technique for tissue diagnosis of pancreatic masses. However, the diagnostic yield is with a~     sensitivity of 64%-95% and an accuracy of 78%-94% still very low. The EUS-FNB of pancreatic~     masses is usually performed with a 22-gauge biopsy needle. The small diameter of the needle~     is usually responsible for the low yield of tissue samples for histopathological examination.~     The 19-gauge needles help to overcome the limitations of a 22-gauge needle by acquiring a~     larger amount of cellular material. Thus, performing EUS-FNB with a 19-gauge needle can~     maximize tissue acquisition and sample adequacy, which is important for appropriate~     diagnosis. Contrariwise, the technical success rate for sample retrieval in patients with~     pancreatic head lesions is significantly lower using the 19-gauge compared to the 22-gauge~     needle. This is attributable to the technical difficulty to push the needle out of the~     endoscope in the duodenum. Since about 60% of pancreatic cancers are located in the head~     region, it is therefore particularly important to improve technical success in these cases.~     The new 19-gauge biopsy needle Olympus EZ Shot3 Plus is more flexible than common biopsy~     needles such as EZ Shot2 and should therefore provide improved access to regions like~     pancreatic head. The aim of this multicenter prospective randomized crossover study is to~     compare those two needles during EUS-FNB of solid pancreatic masses.~      Therefore this study will enroll 40 patients in five German centers with solid pancreatic~     masses and consecutive indication for EUS-FNB. Both needles will be used in each patient~     following a predetermined random order.~      Primary endpoint is the correct histological diagnosis of the mass assessed by each needle.~     Technical failure is regarded as a negative histological diagnosis.~      Secondary endpoints include a comparison of technical failure using each needle, histological~     quality, duration of procedure and rate of adverse events.~   "
50218|NCT02909517|"~     This prospective, non-therapeutic study will determine whether a novel imaging technique can~     identify presumptive tumour associated macrophages (TAMs) in patients with ocular tumours.~      In this study, we will modify the standard angiography protocol by having patients return~     twice in the week following angiography for additional photographs. Photographs will be~     obtained 2-7 days after angiography, but without further injection of dye. This technique~     contrasts with normal angiography in which photographs are taken during the transit phase of~     dye circulation and in the minutes thereafter. Of note, both the dye and the cameras used for~     its detection have been approved for clinical use for several decades and are routinely used~     in the evaluation of patients with ocular tumours.~      We will evaluate 5 groups:~        1. Choroidal nevus (low-risk features): requires distinction from melanoma through~          diagnostic testing~        2. Choroidal indeterminate melanocytic lesion (high-risk features): requires diagnostic~          testing for identification and distinction from nevus and melanoma~        3. Choroidal melanoma: requires confirmation of diagnosis and evaluation for potential~          metatstases~        4. Suspected metastatic tumour (ie, primary tumour elsewhere): requires identification of~          primary tumour~        5. Locally treated ocular tumours: requires followup to evaluate response to treatment and~          potential change or repeat therapy~   "
50219|NCT02909504|"~     This study is a 4-month open-label study of lithium in the acute treatment of patients with~     bipolar I or II disorder. Eligible patients will receive lithium 300 mg twice daily and~     titrated in 300 mg increments every 7 days as tolerated to levels > 0.6 mEq/L. Blood samples~     are collected at baseline and at the end of study. Analyses of 45 molecule expressions in~     mononuclear blood cells at baseline and endpoint will be carried out after the completion of~     study. Fifty patients meeting Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)~     criteria for bipolar I or II will be enrolled.~   "
50220|NCT02909491|"~     The primary objective of this study is to determine whether geriatric inpatients with severe~     behavioral disorders exhibit higher serum ionized calcium concentration than geriatric~     inpatients without behavioral disorders, but no difference in serum calcium or corrected~     calcium concentrations. The secondary objective of this study is to determine whether the~     serum ionized calcium concentration is associated with behavioral and cognitive performance~     among geriatric inpatients.~   "
50221|NCT02909478|"~     Addition of aprepitant, an NK1 receptor antagonist to a 5-HT3 receptor antagonist and~     dexamethasone regimen was shown to be effective for prevention of chemotherapy-induced nausea~     and vomiting (CINV) with moderately emetogenic chemotherapy (MEC). Little is known about the~     efficacy of aprepitant when used without dexamethasone. Dexamethasone is widely used to~     prevent both acute and delayed nausea and vomiting induced by chemotherapy. However,~     multi-period use of dexamethasone could be associated with side effect, such as~     hyperglycemia, dyspepsia and insomnia. This randomized phase III trial studies antiemetic~     therapy with aprepitant and tropisetron to see how well they work compared to dexamethasone~     plus tropisetron in preventing chemotherapy-induced nausea and vomiting in patients with~     colorectal cancer receiving FOLFOX(oxaliplatin, leuvovorin and 5-fluorouracil) chemotherapy.~   "
50222|NCT02909465|"~     Ketamine is the cornerstone of procedural sedation in emergency department but ketamine~     induced agitation has limited its usage by many physicians. As a solution, some propose using~     midazolam or haloperidol before ketamine injection. In this randomized double blind clinical~     trial, patients who are eligible for sedation by ketamine are allocated in 3 groups. In first~     group, the patients will receive 0.05 mg/kg midazolam, in second group 5 mg of haloperidol~     and in 3rd group a placebo five minutes before receiving the sedative dose of ketamine (1~     mg/kg). The patients are assessed for agitation during and after the procedure the~     clinician's satisfaction with sedation instrument is evaluated after the procedure.~   "
50223|NCT02909452|"~     The objectives of this study are to explore different dosing levels and schedules of~     entinostat in combination with pembrolizumab in patients with advanced solid tumors, in terms~     of safety, tolerability, pharmacokinetics (PK), impact on immune correlatives, and efficacy~   "
50224|NCT02909439|"~     This study will compare patient recovery measures after reversal of neuromuscular blockade~     with neostigmine or sugammadex after surgery. Measures include pulmonary function, muscle~     strength, time to extubation and quality of recovery in the post anesthesia care unit.~   "
50225|NCT02909426|"~     Mammography screening has limited performance in young women or women with dense breasts~     although it is the only proven method for breast cancer screening that reduces the mortality.~     The investigators propose a multicenter trial of breast cancer screening to assess the~     effectiveness of supplemental ultrasonography for Korean women aged 40-59 years.~   "
50227|NCT02909400|"~     Mitochondrial Diseases are rare, progressive, multi-system, often-early fatal disorders~     affecting both children and adults. KH176 is a novel chemical entity currently under~     development for the treatment of inherited mitochondrial diseases, including MELAS~     (Mitochondrial Encephalomyopathy, Lactic acidosis, and Stroke-like episodes), MIDD~     (Maternally Inherited Diabetes and Deafness), Leigh's Disease and LHON (Leber's Hereditary~     Optic Neuropathy). The current Proof of Concept study aims to explore the effects of~     treatment with KH176 for 4 weeks on clinical signs and symptoms and biomarkers of~     mitochondrial disease and to evaluate the safety and pharmacokinetics of KH176 in patients~     with m.3242A>G related mitochondrial disease.~   "
50228|NCT02909387|"~     Specific Aim 8. Evaluate the efficacy of Project UPLIFT for reducing symptoms of anxiety,~     depression, and PTSD among African Americans at immediate posttest, after 3 months, and after~     5 months.~   "
50229|NCT02909374|"~     Fall is one of the most common causes of ill health and morbidity in the older population. In~     Sweden about 300 000 people/year seek emergency treatment due to falls and out of these 1600~     dies. Poor balance control leads to a sedentary life with muscle weakness, fear of falling~     and an increased risk for falls. Balance training and physical activity have positive effects~     on fall prevention and balance, but long-term follow-ups are limited. There is also a gap~     between what has been proven to be efficient in research and what is performed in communities~     and clinical settings.~      Many studies reports on the efficacy of certain treatment, method or training program, which~     often may have taken years to develop, but few of these results are taken further into~     clinical practice and it may take years for them to come into daily use. This delay means~     that there is a gap between what is known and what is consistently done. It if of importance~     implement methods that have been proven to have beneficial impact on health and physical~     function in a clinical trial. Furthermore to evaluate which strategies for implementation~     that are of significance. The aim of this study is to implement evidence based balance~     training into clinical practice to prevent future falls and fall-related injuries in older~     adults.~      The program has been proven to be efficient, but not yet been implemented in the community~     and clinical settings. Implementation outcomes will include effectiveness, acceptability,~     feasibility, fidelity, cost and sustainability. Outcome variables on individual level will be~     fall-related concerns, balance performance, physical function and activity, health related~     quality of life and number of falls.~      The investigators foresee that this balance training for older adults will prevent future~     falls and fall related injuries, increase physical activity level, health related quality of~     life and provide the participants with a strategy to be able to have a physically active and~     healthy life style.~   "
50230|NCT02909361|"~     Fulvestrant 500mg in Patients With Advanced Breast Cancer~   "
50231|NCT02909348|"~     There is a new form of cancer treatment called immunotherapy which does not attack cancer~     directly but works on the immune system to make it more effective. This type of treatment may~     have side effects which are called autoimmune side effects and are caused by the immune~     system attacking the normal parts of the body. At the moment doctors cannot predict which~     patients may be at more risk of developing such autoimmune side effects and doctors also~     cannot predict which patients are more likely to benefit. This study will analyse blood~     samples from patients receiving immunotherapy to see if markers can be identified to help~     make such predictions.~   "
50232|NCT02909335|"~     Tacrolimus is a calcineurin inhibitor. This is the immunosuppression of reference for~     patients undergoing a first liver transplant. This treatment can prevent graft rejection, but~     can cause side effects including kidney failure (in 25% after the first year).~      Everolimus is an immunosuppressive that effectively prevents acute rejection in heart and~     kidney transplant recipients. It preserves renal function when it is started soon after the~     transplant, i.e. before a severe dysfunction is installed.~   "
50233|NCT02909322|"~     The best mode of analgesia delivery after hepatectomy is currently unknown. Many institutions~     routinely use continuous epidural analgesia (CEA) for pain control in this patient~     population. A functioning CEA provides adequate analgesia, but is associated with high~     failure rates (20-30%) and sometimes significant hemodynamic disturbances (hypotension)~     requiring an increased amount of intravenous fluid and blood products to maintain~     homeostasis. Furthermore, its safety has been the subject of debate in liver resection~     patients due to the elevated risk of epidural hematoma and its serious neurological~     consequences. These limitations highlight the need to explore other options for analgesic~     control after hepatectomy, such as paravertebral block (PVB). PVB has been shown to provide~     similar analgesia with a lower incidence of pulmonary complications, side effects (pruritis,~     urinary retention, nausea and vomiting, hypotension), and failure rates (6.1%) when compared~     to CEA in thoracic surgery, and therefore has been suggested as a safer alternative in~     hepatectomy patients. Despite this, there are no studies comparing the efficacy of CEA and~     PVB as analgesic techniques after hepatectomy. The investigators propose a randomized~     controlled trial to compare the analgesic efficacy, side effects, and complications~     associated with CEA and PVB in patients undergoing elective hepatectomy through a right~     subcostal incision.~   "
50234|NCT02909309|"~     Evaluation of a Mandibular and Abdominal Motion Detection Sensor (JAWAC) to Prevent Apnea~     During Sedation With Propofol in TCI Mode~   "
50235|NCT02909296|"~     The pancreatic surgery causing some pancreatic collections. And in a number of case, this~     surgery can require a surgical resumption, a percutaneous drainage or an endoscopic drainage.~      The endoscopic care of the treatment of pancreatic collections post-surgery is not yet~     standardized.~      After failure of the medical treatment, the drainage of collections by echo-endoscopy was~     described.~      There are not much series on this specific subject. Only 2 series contain more than 20~     patients with 31 patients for the most important.~      The timing and the technical choice of the endoscopic treatment as well as the long-term~     follow-up are not clear.~      The purpose of this study is to estimate the success and the complications of the endoscopic~     drainage by echo-endoscopy according to the techniques of drainage and the timing of the~     endoscopic treatment.~      The not estimated long-term follow-up will be also considered.~   "
50236|NCT02909283|"~     The aim of this study is to evaluate determinants of cerebral oxygenation and perfusion at~     the microcirculatory level in children with sickle cell anemia (SCA) using combined novel~     investigational tools: Arterial Spin Labeling (ASL) perfusion MR (Magnetic Resonnance)~     imaging, brain Near Infra-Red Spectroscopy (NIRS) and red blood cell (RBC) rheological~     properties.~   "
50237|NCT02909270|"~     A randomized, single-blind, multi-center, Phase III clinical trial to evaluate the efficacy~     and safety of adhesion barrier Mediclore versus no treatment in patients with total~     thyroidectomy~   "
50238|NCT02909257|"~     Femoral nerve blocks are commonly used to provide pain control for total knee replacement,~     anterior cruciate ligament (ACL) reconstruction. Commonly employed local anesthetic~     concentrations result in motor block of the quadriceps and constitute an inherent risk factor~     for patient fall.~      The aim of this study is to determine the minimum effective concentration of bupivacaine in~     90 % of patients (MEC90) required for a motor-sparing, successful sensory block of the~     femoral nerve.~   "
50239|NCT02909244|"~     Some Primary Immune Deficiencies can be associated with an inflammatory bowel disease,~     mimicking Crohn disease : the Chronic Granulomatous Disease (CGD), the XIAP deficiency, and~     the TTC7A deficiency.~      This inflammatory bowel disease is frequent but inconstant, raising questions about other~     factors contributing to the disease. The aim of our study is to analyze, describe and compare~     the gut microbiota of patients with those primary immune deficiency, with or without~     intestinal disease.~      The investigators can expect, in the long term, to compare on a same patient, the gut~     microbiota evolution, and to assess the role of gut microbiota modifications on the onset of~     an inflammatory bowel disease.~   "
50240|NCT02909231|"~     This study evaluates the three, six, and twelve month patient reported outcomes of people~     admitted two trauma centres in western Canada over a four month period. Participants are~     evaluated using the Trauma Outcome Profile and a custom survey instrument.~   "
50241|NCT02909218|"~     The purpose of this study is to evaluate the feasibility, acceptability, clinical outcomes,~     affordability, and scalability of offering early antiretroviral treatment to all HIV-positive~     individuals in Swaziland's government-managed health system.~   "
50242|NCT02909205|"~     The aim of the study is to improve care practice related to gastrostomy management. This a~     before-after study, aimed at evaluating knowledge of care givers, families and patients about~     gastrostomy management. The intervention includes 1) A training in a care protocol for~     hospital care givers, and 2) A booklet for patients, families, and outpatient care givers.~     The evaluation criterion is a questionnaire to assess knowledge of hospital care givers,~     patients, families, and outpatient care givers.~   "
50243|NCT02909192|"~     Disruption of sleep and alertness is one of the most disabling non-motor symptoms of~     Parkinson's disease (PD). Mechanisms leading to impaired sleep and alertness in PD are not~     well understood, and treatment options remain limited. The proposed research will examine~     markers of the circadian system, sleepiness and sleep quality in PD patients. Further, the~     project will examine effects of bright light exposure on circadin function, sleep and~     alertness in PD.~   "
50244|NCT02909179|"~     The purpose of this community-based randomized controlled trial is to test whether the~     mCARE-II intervention package, delivered by the existing Government of Bangladesh community~     health workforce, will improve neonatal and perinatal survival in a rural setting in~     northwestern Bangladesh. mCARE-II is a digital health intervention, which incorporates~     automated workload scheduling, client prioritization and risk stratification, overdue service~     reminders and demand generation through client side reminder messaging. The intervention~     package focuses on the pregnancy and early postpartum period.~   "
50245|NCT02909166|"~     The aim of the study is to find out whether aliskiren reduces atrial fibrillation burden~     measured with a pacemaker device~   "
50246|NCT02909153|"~     The main purpose is to determine the pharmacokinetic (PK) profile, maximum concentration~     (Cmax) and Area Under the Concentration Time Curve (AUC0-t) of Triferic iron administered~     intraperitoneally in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD).~     It is an open label, dose escalation study.~   "
50247|NCT02909140|"~     Obtaining appropriate mydriasis prior to cataract surgery is an important variable in~     successful surgery. The current practice includes using topical anticholinergic and~     sympathomimetic agents in the preoperative area prior to cataract surgery, but the pupils are~     sometimes insufficiently dilated and can often need additional mydriasis with intracameral~     agents during cataract surgery. Pre-operative topical mydriatic drops take time to take~     effect, are mildly uncomfortable for the patient, and have a cost to the healthcare system.~     If intracameral mydriasis alone can achieve adequate pupil dilation, perhaps topical~     mydriatics would not be needed. The purpose of this study is to evaluate whether topical~     versus intracameral versus topical + intracameral mydriasis is the optimal way to dilate~     pupils during routine cataract surgery. The results of this study have implications for~     improving the efficiency and reducing time prior to cataract surgery. In addition, it has~     significant potential to reduce the cost associated with cataract surgery if preoperative~     drops can be eliminated.~   "
50248|NCT02909127|"~     There is no dysphagia spesific and patient/parent centered outcome instrument in the~     pediatric population. The purpose of this investigation is to develop the Pediatric version~     of the Eating Assessment Tool (PEDI-EAT-10) and investigate its validity and reliability.~   "
50249|NCT02909114|"~     Single arms prospective phase II study of SBRT for oligometastatases from colorectal cancer~   "
50250|NCT02909101|"~     The purpose of this study is to examine the effects of a cognitive training program in~     persons with Human Immunodeficiency Virus (HIV) infection who have used cocaine. This study~     tests the feasibility and preliminary efficacy of a computerized cognitive training program~     to improve working memory and decrease impulsivity (delay discounting) among HIV-infected~     individuals.~   "
50251|NCT02909088|"~     The primary objective of this study is to evaluate the efficacy and tolerability of ecopipam~     in reducing stuttering symptoms.~      It is hypothesized that ecopipam effectively reduces stuttering symptoms as measured on the~     SSI-IV total score, the CGI, SSS and OASES.~   "
50252|NCT02909075|"~     The purpose of this study is to see if a positron emission tomography/computed tomography~     (PET/CT) scan and a magnetic resonance imaging (MRI) of the chest can assess changes in the~     thymus size and function. The researchers would like to monitor the thymus with a PET/CT scan~     and a MRI before and after the participants transplantation.~   "
50253|NCT02909062|"~     Electronic activity monitoring (EAM) devices are wearable electronic devices that monitor~     functional activity and provide personal feedback on activity progression. This study aims to~     determine if EAM can provide an objective, assessment of patient functional activity. The~     study will also examine the change in functional activity experienced by patients during the~     first cycle of chemotherapy. Another objective of the study will be to see if baseline~     functional activity and the change in functional activity that occurs during the first cycle~     of chemotherapy can be used to predict patient tolerability of subsequent cycles of~     chemotherapy.~   "
50254|NCT02909049|"~     To assess the effectiveness of two anesthetic techniques by measuring the pain through visual~     analog scale (VAS), to obtain saturation prostate biopsies.~   "
50458|NCT02906384|"~     This is a prospective, randomized phase-II study observing the memory preservation and~     functional brain MRI changes with conformal avoidance of the hippocampal neural stem-cell~     compartment during prophylactic cranial irradiation for small cell lung cancer patients.~   "
50255|NCT02909036|"~     Captisol Enabled Melphalan, is a new formulation of the standard of care melphalan~     chemotherapy that in packaged in an inactive substance that is believed to help the~     chemotherapy be more stable (meaning that it doesn't lose its effect or need to be~     administered quickly after being mixed). It may also have fewer side effects such as problems~     with important levels of body electrolytes such as potassium, phosphorous and magnesium; and~     cause less kidney and heart damage] than standard formulation melphalan.~      The purpose of this study is to determine if the investigators can achieve a certain level of~     Captisol Enabled Melphalan that would be best to use in treating Multiple Myeloma and AL~     Amyloidosis.~   "
50256|NCT02909023|"~     Activation of the immune system against a pathogen can be considered one of the most~     effective interventions in the field of infectious diseases.~      Transgene is developing a therapeutic vaccine TG1050 for the treatment of patients with~     chronic and treated Hepatitis B. This biotherapy compound is for the development of T~     cellular immune response in these patients in order to achieve the total elimination of~     infected cells.~      Therefore it is necessary to have measures of ways to assess accurately and reliably the~     presence of such a response in the study subjects.~   "
50257|NCT02909010|"~     A randomized, control trial to compare the total dose of sedatives use in patients over 65~     years admitted to the intensive care unit, guiding sedation by monitoring with BIS® versus~     monitoring with the exclusive use of sedation scales.~      The study will include all patients over 65 years who enter the intensive care unit of the~     University Hospital of Bellvitge affected with medical or surgical pathology of non~     neurological etiology who require sedation for more than 24 hours to maintain adaptation to~     mechanical ventilation.~   "
50258|NCT02908997|"~     A study to investigate the effectiveness of a reminder tool application at increasing~     performance on memory tasks in people with mild dementia~   "
50259|NCT02908984|"~     In part 1 of the project clinical efficacy of specific neck rehabilitation will be compared~     with standard primary health care among patients with cervicogenic headache and study whether~     fear avoidance beliefs and self-efficacy predict long term neck function and headache~     frequency superior to active range of neck movement. Part 2 will investigate whether patients~     with cervicogenic headache have changes in cerebral grey and white matter and in connectivity~     of the resting state state network, whether these are reversed after effective neck~     rehabilitation, and correlate to symptom severity and degree of disability.~   "
50260|NCT02908971|"~     Background: Children in industrialized and developing countries have a higher tendency to~     present earlier signs of puberty. One hypothesis includes the hormonal effects of~     phytoestrogens found in soy products.~      Objective: to examine the association between consumption of soy-based food in early infancy~     and childhood and the incidence of early or precocious puberty and overweight in school-aged~     children.~      Methods: the study population for this case control study is randomized from a prospectively~     followed cohort of all babies born at Assaf Haroffeh medical center and followed for milk~     allergy signs and food intake until the age of 3 years (A nested cohort). It is divided to~     those who were allergic to milk, and thus consumed only soy based formula and food during~     infancy and childhood (soy group) and a randomized control group who consumed non-soy based~     intake. For both groups data are available of food habits during infancy and collected from 3~     days food diaries during the current study. Physical examination, including weight , height,~     blood pressure and Tanner Pubertal Staging will performed annually.~   "
50261|NCT02908958|"~     To evaluate the safety and efficacy of PEG Somatropin Injection (Jintrolong®) in the~     treatment of short stature due to endogenous growth hormone deficiency (GHD) in the broad of~     population of children.~   "
50262|NCT02908945|"~     Monitoring the brain using electroencephalography (EEG) during general anesthesia provides~     the anesthesiologist with valuable feedback of how deeply anesthetized their patient is,~     reducing the chances of under- or overdosing and potentially improving patient outcomes.~     However, commercial EEG monitors that output processed EEG (pEEG) were developed under~     carefully controlled, simple anesthetic regimes - in contrast to the multimodal cocktail of~     drugs often used in clinical practice. Ketamine is one potential adjunct to a standard~     anesthetic, which has a growing body of evidence suggesting that it may improve~     post-operative outcomes. The effects of ketamine on pEEG parameters are poorly understood.~     This randomized, open-label, feasibility study will be undertaken in a sample of 30 adult~     outpatient surgery patients. The primary objective is to observe the intra-operative raw and~     pEEG trends using the NeuroSENSE monitoring system in patients receiving one of two different~     analgesic doses of ketamine, compared to patients not receiving ketamine, during an otherwise~     comparable general anesthetic. Secondarily, we will consider other clinical data of interest~     from both intra- and post-operative contexts in order to establish a broader understanding of~     the potential influence of two analgesic ketamine doses on anesthetic depth and~     post-operative outcomes. Feasibility outcomes will be assessed with the ultimate goal of~     developing a larger-scale clinical trial.~   "
50263|NCT02908932|"~     The goal of this study is to determine if supplementation with krill oil concentrate~     containing the phospholipid-bound omega-3 fatty acids improves performance on specific~     cognitive tests that underlie key elements in U.S. Army Infantry Basic Officer Leaders Course~     (IBOLC) and in Ranger School (Training) at Fort Benning, Georgia (GA).~   "
50264|NCT02908919|"~     The purpose of this study is to determine optimal time intervals for preparation before~     colonoscopy using different formulas.~   "
50265|NCT02908906|"~     The Primary purpose of this study is to identify the recommended Phase 2 dose [RP2D(s)] for~     JNJ-63723283 in Part 1 and to assess the anti-tumor activity of JNJ-63723283 at the RP2D(s)~     in participants with selected advanced cancers including non-small-cell lung cancer (NSCLC),~     melanoma, renal, bladder, small-cell lung cancer (SCLC), gastric/esophageal cancer, and~     high-level microsatellite instability (MSI-H) or mismatch repair-deficient (dMMR) colorectal~     cancer (CRC) in Part 2.~   "
50266|NCT02908893|"~     The investigators design a 6-week messaging campaign aimed at promoting flu vaccination among~     fully insured members of a national payer that participate in a wellness program offered by~     the insurer through a mobile app. Outcomes measured will include uptake in flu vaccination~     rate as measured by the insurer and engagement with the campaign through the app.~      The goal of the research is to assess the effectiveness of pervasive computing messaging in~     promoting preventative care treatments such as flu shots. An additional goal is that of~     quantifying the importance of emphasizing incentives to increase efficacy of the messages.~   "
50267|NCT02908880|"~     Research study which tests the safety and effectiveness of a new vascular closure device to~     close the femoral access puncture that is created in patients who require this form of access~     in order to perform the planned procedure. The MANTA device is expected to seal the femoral~     access puncture in less than 1 minute. This may result in less blood loss and a shorter time~     to walking compared to alternative closure means. Use of the MANTA device in this study is~     experimental. All other parts of the procedure involve standard medical care.~   "
50268|NCT02908867|"~     Objectives: To know the main therapeutic strategies used by men with spinal cord injury in~     sexual dysfunctions.~   "
50269|NCT02908854|"~     A two-phase, school-based intervention will be conducted at a high school in Baltimore to~     evaluate whether the addition of spices and herbs to vegetable dishes in the National School~     Lunch Program (NSLP) can increase vegetable intake among students in an urban and~     predominantly African-American high school.~   "
50270|NCT02908841|"~     Surgicel Snow is an FDA approved topical hemostatic agent for use during surgical procedures.~     Like the other mechanical agents, Surgicel Snow forms a physical barrier that blocks blood~     flow while providing a large surface area for the rapid formation of a fibrin clot. As a~     mechanical agent derived from oxidized regenerated cellulose, Surgicel Snow shares with other~     mechanical hemostatic agents, the benefits of a favorable risk profile. This study would~     examine the efficacy of Surgicel Snow vs. direct compression in the control of capillary,~     venous, and small arterial hemorrhage when ligation or other conventional methods of control~     are impractical or ineffective in patients undergoing laparoscopic or robotic assisted~     laparoscopic hysterectomy. The intraoperative inclusion bleeding characteristics are minimal~     and mild retroperitoneal bleeding and moderate retroperitoneal bleeding that has been~     adequately reduced by standard surgical methods. 60 patients will be recruited for this~     study, all of which will be scheduled for hysterectomy at Western Connecticut Health Network~     (Norwalk Hospital and Danbury Hospital) under the direction of Dr. Thomas Rutherford, Dr.~     John Garofalo, and Dr. Robert Samuelson. The investigators will randomize 30 patients to the~     treatment group and 30 patients to the control group. Participants may continue all regular~     medications before and during the study. The consent process will be incorporated into the~     last pre-operative office visit. The health risks associated with use of Surgicel Snow may be~     less, the same or more than direct pressure alone. Surgicel Snow is generally used for~     minimal to mild bleeding from specific or widespread area; however, its effectiveness~     compared to direct pressure is unknown for a hysterectomy surgery.~   "
50271|NCT02908828|"~     Copepod oil is extracted from the marine copepod Calanus finmarchicus, the dominant plankton~     species in the marine food web in the Norwegian Sea. Copepods constitute the largest~     renewable and harvestable resource in the Norwegian Sea and adjacent waters, and it is now~     developed knowledge and technology for sustainable harvesting of this new resource. The~     purpose of this study is to investigate whether Calanus copepod oil supplementation has an~     equivalent effect on maximal oxygen uptake in humans to that seen in experimental studies in~     mice.~   "
50272|NCT02908815|"~     The main objective of this study is to investigate the effects of repetitive Transcranial~     Magnetic Stimulation (rTMS) treatment on patients with probable early or moderate Alzheimer's~     disease.~   "
50273|NCT02908802|"~     Subjects will answer the following questionnaire and tests:~        -  Symptom severity and improvement will be measured using ADHA Rating scale IV (ADHD RS)~        -  Demographic Questionnaire - composed by the researchers~        -  Family Eating Habits Questionnaire (FEAHQ-33)~        -  Food Frequency Questionnaire (FFQ)~        -  Test MOXO~      The subjects will take the study product for six months.~      After six months the subject will fill once again all the questionnaires.~   "
50274|NCT02908789|"~     This project aims to evaluate the effect of antimicrobial photodynamic therapy (aPDT) in deep~     carious lesions. This is an in vivo study approved at the Research Ethics Committee, which~     will be conducted in 30 patients between 3 and 12 years. Patients included in the study~     should have at least one primary molar or permanent with deep active caries limited occlusal~     / proximal surfaces involving beyond the inner half of dentin. The investigators will~     considered from exclusion criteria children whose parents refuse to sign the informed consent~     document; children who do not cooperate with the clinical examination/treatment; children~     with syndromes or chronic systemic diseases; teeth with painful symptoms consistent with~     irreversible pulpitis or mobility; periodontal changes; roots with pathological resorption;~     cases of primary teeth roots in advanced stage of physiological resorption and patients that~     have made the use of any antibiotics during the study period or within three months prior to~     its beginning. The treatments will be carried out after local anesthesia and isolation of the~     operative field with a rubber dam. The removal of carious dentin surface demineralized~     necrotic and not subject to remineralization will be held with drill at low rpm under cooling~     with sterile saline. The removal of decayed tissue will start by the side walls and later on~     the pulp wall. After this time the intervention with aPDT using 0.01% methylene blue as~     photosensitizer will be held. Finally, the cavity is restored with adhesive and composite~     resin system. The dentin samples will be collected with the help of spoon sterile dentine in~     two stages: C1 after digging and C2 after aPDT. The microbiological analyzes will be~     conducted with counting of colony forming units (CFU / mg of carious dentin), blindly from~     coded samples. The viability of microorganisms will be evaluated in the following culture~     media: Brain Heart Infusion agar for feasibility total microorganisms; CHROMagar candida to~     Candida genus; Mitis Salaviarius agar with addition of bacitracin 0.2 U/mL, sucrose and~     glucose to Streptococcus mutans; Mitis Salivarius agar to total Streptococcus; Rogosa Agar to~     Lactobacillus spp. and enterococcosel for Enterococcus genus. The reproducibility of the~     counting method will be verified between triplicates. Microbiological data will be evaluated~     with appropriate statistical tests with a level of 5%. Based on this project is expected to~     prove the clinical efficacy of aPDT using 0.01% methylene blue as an adjunct in reducing of~     microorganisms from interior of deep carious lesions contributing to the clinical and~     radiographic success.~   "
50275|NCT02908776|"~     MYDA-MI study is a randomized, placebo controlled, double blind study performed in San~     Filippo Neri Hospital, Roma, Italy. The planned study duration is 18 months. The objectives~     are to assess the effects of pre-treatment with probiotic Ecoviesel on the incidence and~     magnitude of peri-procedural myocardial damage caused by coronary angioplasty in stable~     patients. 250 patients with chronic stable angina scheduled for a coronary angiography and~     possible ad hoc angioplasty will be randomized to receive pre-treatment with Ecoviesel~     sachets (each sachet contains 200 billions bacteria) or Placebo. The pre-treatment dosage~     will be 4 sachets of probiotic Ecoviesel or placebo for at least 2 weeks before the planned~     procedure. In patients undergoing angioplasty the same treatment will be continued for 4~     weeks after PCI with secondary outcome measures performed at the end of this second stage.~   "
50276|NCT02908763|"~     HBsAg Loss/Seroconversion is uncommon in Low replicative chronic HBV infection patients. The~     purpose of this study is to investigate the ability of peginterferon alpha to achieve HBsAg~     loss/seroconversion therapy in Low replicative chronic HBV infection patients with Low Level~     HBsAg.~   "
53282|NCT02869516|"~     Database of Institut Paoli-Calmettes patients diagnosed with Acute Leukemia~   "
50277|NCT02908750|"~     This is a Phase I, open-label, 2-part study in patients with a confirmed diagnosis of~     epidermal growth factor receptor (EGFR) mutation positive (EGFRm+) non-small cell lung cancer~     (NSCLC), who have progressed following prior therapy with an approved EGFR tyrosine kinase~     inhibitor (TKI) agent.~      Part A will assess the effect of osimertinib on the pharmacokinetic (PK) parameters of~     fexofenadine, following single and multiple oral dosing of osimertinib in a fasted state.~      Continuous Access will allow patients further access to osimertinib after the PK phase (Part~     A). All patients from Part A who completed treatment may continue to receive osimertinib 80~     mg once daily until: they are no longer deriving clinical benefit; or any other reason.~   "
50278|NCT02908737|"~     The clinical study is designed to evaluate the safety and effectiveness of recipient~     controlled Bass and Treble.~   "
50279|NCT02908724|"~     The purpose of this study was to assess the progression of cardiac involvement in adult~     patients with Fabry Disease (FD), in the unique Danish Fabry cohort and comparing those FD~     patients receiving primary therapy vs. those that did not.~      The hypothesis is, that we will not be able to see a significant positive difference in~     cardiac involvement in those FD patient who received FD specific therapy vs. those that did~     not.~   "
50280|NCT02908711|"~     Total knee arthroplasty (TKA) is associated with severe postoperative pain. Multimodal~     analgesia, including peripheral nerve block, is recommended for post-operative pain relief 1.~     Perineural analgesia offers the advantage of extended pain relief up to 24 hours after~     surgery2.~      This is a prospective, randomized control trial designed to compare the analgesic efficacy of~     the adductor canal block (ACB) performed immediately before or immediately after primary~     total knee arthroplasty (TKA). The primary objective of this study is to measure pain score~     associated with knee motion following TKA among patients receiving ACB as part of their~     analgesic regimen for TKA. Secondary end points include assessment of postoperative~     ambulation, range of motion, pain at rest, opioid consumption, and patient satisfaction~     between the two analgesic approaches. The investigators hypothesize that ACB before the~     surgery will reduce a patient's postoperative pain and improve patient satisfaction.~      All consecutive patients undergoing primary TKA will be recruited for enrollment in the~     study. Patients will be for randomized preoperatively to receive either preemptive ABC~     (PreACB) or postoperative ABC (PostACB). Patients randomized to the PreACB group will receive~     the block prior to incision. Patients randomized to the PostACB group will receive the block~     at the end of the surgery. Both techniques are in accordance to the standard of care at our~     institute. All patients will have the ACB done by a regional anesthesiologist in the regional~     anesthesia unit, or in the operating room. Patient medical history will be obtained and~     blocks will be placed per usual protocol. Operative and anesthetic details, including~     medications given, will be recorded.~      Pain scores and pain medications given in the PACU will be recorded. Supplementary analgesics~     will be provided per institutional PACU protocol. Study data will be recorded for up to 72~     hours or until patient discharge. A follow-up will occur in 4- 6 weeks at the orthopedic~     follow-up appointment to evaluate the patient's late pain scores and overall satisfaction.~     Data will be analyzed both at the conclusion of the study and at several intervals prior to~     completion of the study.~   "
50281|NCT02908698|"~     Atopic Dermatitis (AD), also known as eczema, is a common skin disease characterized by itchy~     lesions. The prevalence of AD has increased over the past few decades, with 15-30% of~     children and 2-10% of adults being affected. The lesions of atopic dermatitis patients are~     very inflamed, with an increased number of inflammatory cells in the skin. The first line~     treatment for AD is steroids, which reduce inflammation in the skin. There are several ways~     to measure if the treatment is effective, including clinical and cellular. We are proposing~     that a controlled skin allergen challenge will be an effective way to measure the effect of~     steroid at a cellular level through the measurement of inflammatory cells in the late~     cutaneous response. This will be examined using a placebo-controlled trial.~   "
50282|NCT02908685|"~     Multi-center, randomized, double-blind, placebo-controlled, Phase II study to assess the~     safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RO7034067 in adult~     and pediatric participants with Type 2 and Type 3 SMA. The study consists of two parts, an~     exploratory dose finding part (Part 1) of RO7034067 for 12 weeks and a confirmatory part~     (Part 2) of RO7034067 for 24 months.~   "
50283|NCT02908672|"~     This is a Phase III, double-blinded, placebo-controlled, randomized, multicenter study~     designed to evaluate the efficacy, safety, and pharmacokinetics of atezolizumab + cobimetinib~     + vemurafenib compared with placebo + cobimetinib + vemurafenib in patients with previously~     untreated BRAFv600 mutation-positive metastatic or unresectable locally advanced melanoma.~   "
50284|NCT02908659|"~     In ICU setting, a large number of medical devices are attached to patients, generating~     numerous alarm signals. Several studies have demonstrated that most of these alarms are not~     clinically relevant and tend to lower the attentiveness of healthcare professional and, in~     turn, lower patient safety.The aim of the study is to assess the relevance of respiratory~     rate alarm on a monitoring device in non-ventilated ICU patients.~      The investigator primary hypothesis is that this alarm is potentially useless. If this~     hypothesis is confirmed, a second interventional trial will be conducted on the impact of~     this alarm removal.~   "
50285|NCT02908646|"~     Both of microcoil localization and hookwire localization have been proved as good~     preoperative CT(computed tomography)-guided techniques to guide VATS resection for the~     diagnosis of small peripheral pulmonary nodules technique to guide VATS resection for the~     diagnosis of small peripheral pulmonary nodules. The objective of this study is to determine~     if microcoil localization for pulmonary nodules can be safer than hookwire localization~   "
50286|NCT02908633|"~     It is a comparative study of Safety and Efficacy of Three Variants of Canaloplasty:~     ab-externo, ab-interno and minicanaloplasty. Combined With Phacoemulsification to Treat~     Glaucoma and Cataract. It is a Randomised, Prospective Study.~   "
50287|NCT02908620|"~     The purpose of this study is to determine if the topical application to cheek tissue of the~     combination of benzocaine and tetracaine has a longer duration of local anesthetic activity~     than benzocaine alone.~   "
50288|NCT02908607|"~     When screening results for cervical premalignant lesions are positive, colposcopy is~     recommended. This is highly sensitive screening method. However, specificity of the test is~     of low.~      Thus, a technology that improves the accuracy of the colposcopic exam is needed.~      This is a feasibility study with the goal of examining the performance of a thermal imaging~     camera in the detection of cervical malignant and premalignant lesions.~   "
50310|NCT02908321|"~     Children with Autism Spectrum Disorder (ASD) often have other difficulties as a result of the~     disorder. Up to half of the children with ASD are thought to suffer with anxiety in a way~     that interferes with their wellbeing and every day functioning. In this project the~     investigators will study the effect of the group program The Cool Kids Anxiety Program:~     Autism Spectrum Disorder Adaptation (Cool Kids ASD) - an anxiety treatment program specific~     developed for children with ASD. The investigators expect a decrease in the overall anxiety~     level together with an increase in the ability of handling anxiety.~   "
53283|NCT02869503|"~     Database of Institut Paoli-Calmettes patients diagnosed with colorectal cancer~   "
50289|NCT02908594|"~     Aim. To investigate the effect of an intradialytic aerobic and resistance cycling exercise~     program (IARCEP) on depression, fatigue, and quality of life (QOL) in end-stage renal disease~     (ESRD) patients receiving haemodialysis, and further determine the effect of mediation~     through self-efficacy and resilience in patients receiving the IARCEP.~      Background. Depression and fatigue are common in ESRD patients undergoing haemodialysis,~     which negatively affects their QOL. Exercise can mitigate this effect. Patient's~     self-efficacy and resilience may be crucial mediators in exercise.~      Design. This study was a randomised controlled trial. Method. Seventy-six participants were~     randomly assigned to either a control or exercise group. Both groups received routine care;~     whereas the exercise group participated the 3- months IARCEP. Data were collected at~     baseline, the first, second, and third months, over a 14 months in 2013-2014.~   "
50290|NCT02908581|"~     This study will be conducted to observe any change in fungal pattern on skin of arsenicosis~     patients before and after administration of iron (150 mg) and folic acid (0.5 mg) tablets.~   "
50291|NCT02908568|"~     Study over muscular stretching to reduce pain the oral cavity.~   "
50292|NCT02908555|"~     The purpose of this exploratory study is to evaluate the characteristics of sleep,~     perceptions of barriers and facilitators to adequate sleep, and the associations among sleep~     characteristics, executive functioning, coping, adherence, 24-hour glucose levels, and~     adjustment in adolescents with type 1 diabetes. A mixed methods approach that includes a~     quantitative component, consisting of actigraphy and sleep diaries, questionnaires, tests of~     executive function and continuous glucose monitoring (CGM) as well as a narrative qualitative~     component will be used. Results from this pilot study will be used to provide the effect~     sizes needed for a larger-scale descriptive study and to establish the need for a possible~     sleep-promoting intervention for adolescents with type 1 diabetes. This project is consistent~     with ongoing research focused on developing preventive, behavioral interventions for youth~     with type 1 diabetes and their families to improve physiological (i.e., glycemic control) and~     psychological (i.e., quality of life) outcomes. Sleep promotion may become an important~     component of these interventions. Thus, the following specific aims will be addressed:~        1. Describe the objective and subjective characteristics of sleep (duration, continuity,~          bed time/rise times); sleep quality and sleep habits among adolescents with type 1~          diabetes.~        2. Explore the relationship between characteristics of self-reported sleep (i.e., habits,~          duration, daytime sleepiness) and executive function, coping, adherence, and adjustment~          (i.e., depressive symptoms, quality of life) in adolescents with type 1 diabetes.~        3. Explore the relationship of glucose excursions on sleep characteristics and executive~          functioning.~      3. Conduct a qualitative study using narrative analysis with adolescents to identify~     perceived barriers, facilitators, and consequences associated with insufficient sleep in~     adolescents with type 1 diabetes.~   "
50293|NCT02908542|"~     Hypercalcemia, whether chronic or acute, exposes the patient to potentially serious~     complications (arrhythmias, nephrolithiasis, nephrocalcinosis, ...). Prevention relies~     primarily on effective etiological necessary for taking matched load. Under the French~     reference center for rare disorders of calcium and phosphorus, the investigators looked for~     mutations in the coding sequence of the CYP24A1 gene (encoding the enzyme responsible for the~     breakdown of vitamin D), among patients with hypercalcemia without hyperparathyroidism with~     hypersensitivity to vitamin D. However, only 25% of these patients have a genetic anomaly~     suggesting the involvement of other genes (Molin et al. 2015). Recently our team, combined~     with Kaufmann et al. (2014 JCEM) validated the interest of the determination of metabolites~     of vitamin D by liquid chromatography-tandem mass spectrometry (LC-MS / MS), as biological~     pre-screening stage for patients with hypercalcemia.~      The objective of this project is to complement the molecular and biochemical studies of~     patients without mutation of the coding sequence of CYP24A1, in a gene candidate approach~     using massively parallel sequencing (MPS) which allows to study a panel of gene potentially~     involved in disorder of metabolism of calcium and phosphorus. Highlighted variations will be~     tested in silico, and if possible in vitro. The investigators will also use LC-MS / MS to~     evaluate in vivo the effects of these variations on the metabolism of vitamin D, to develop a~     genotype / phenotype correlation.~      The work carried out within the Genetics Department Caen University Hospital in collaboration~     with physicians of the rare disease reference center of the metabolism of calcium and~     phosphorus should identify new genetic mechanisms underlying hypercalcemia. At the time of~     development of personalized medicine, it will adapt the therapy in patients at risk for~     metabolic complications and / or kidney following administration of vitamin D and finally to~     offer genetic counseling.~   "
50294|NCT02908529|"~     Obstructive sleep apnea (OSA) is common and has major health implications but treatment~     options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle~     activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared~     to normal subjects. Until recently, the search for medicines to activate pharyngeal muscles~     in sleeping humans has been discouraging. However, exciting new animal research has shown~     that drugs with noradrenergic and antimuscarinic effects can restore pharyngeal muscle~     activity to waking levels. In this protocol the investigators will test the effect of~     atomoxetine (a norepinephrine reuptake inhibitor) and oxybutynin (an antimuscarinic drug)~     administered together on OSA phenotype traits and OSA severity during sleep.~   "
50295|NCT02908516|"~     The primary objective of this study is to assess the safety and efficacy of Tranexamic acid~     (TXA) in reducing blood loss and transfusion requirements for patients with osteoporotic hip~     fractures. In addition to assessing blood loss in these patients, complications associated~     with TXA use would be characterized including systemic (pulmonary embolism, deep venous~     thrombosis, myocardial infarction, stroke) and surgical site (hematoma, infection) events,~     need for re-hospitalization or re-operation and 30 day mortality.~   "
50296|NCT02908503|"~     The purpose of this study is to evaluate use of four different vaginal films - two sizes and~     two textures. The vaginal films have no active ingredients or medications. Information will~     be gathered about each film (i.e. ease of insertion, proper placement, opinions about each).~     The results of this study will help investigators determine which type of vaginal film to use~     (and how to write product instructions) for future studies.~   "
50297|NCT02908490|"~     The purpose of this study is to determine whether sildenafil improves parameters of vascular~     function and blood markers involved in development of heart disease in patients with~     rheumatoid arthritis.~   "
50298|NCT02908477|"~     This study is designed for patients with a cancer of the oropharynx (tonsils or base of~     tongue) caused by the HPV virus. Traditional treatment involves surgery followed by six weeks~     of daily radiation therapy. This study investigates a less intense radiation treatment~     following surgery that uses half the dose of radiation given over two weeks rather than six~     weeks. Patients will be randomly assigned to receive the less intense treatment versus the~     traditional treatment by coin flip. Patients are twice as likely to receive the less intense~     treatment during randomization.~   "
50299|NCT02908464|"~     The purpose of this trial is to determine whether using a brain training program in the time~     leading up to as well as after heart surgery will reduce confusion and cognitive loss that~     can occur after surgery.~   "
50300|NCT02908451|"~     This study is to define the safety profile and to determine the maximum tolerated dose (MTD)~     and preliminary efficacy of AbGn-107 administered every 28 days (4 weeks) in patients with~     chemo-refractory locally advanced, recurrent or metastatic gastric, colorectal or pancreatic~     adenocarcinoma.~   "
51965|NCT02886728|"~     The primary objective of this study is to evaluate the effects of filgotinib in combination~     with methotrexate (MTX) versus MTX alone in adults with active rheumatoid arthritis (RA).~   "
50302|NCT02908425|"~     Statins are a class of drugs that are the most commonly prescribed medications in developing~     countries. Statins act on the enzyme HMG-CoA reductase to inhibit its conversion to~     mevalonate, a precursor for cholesterol synthesis. Subsequently statins are prescribed to~     patients with relatively high blood cholesterol levels. However, taking statins does not come~     without side effects. Most notably, the effects of statins on muscle wasting have been~     studied extensively. This includes up-regulation of the ubiquitin proteasome system, muscle~     cell damage and rhabdomyolysis, elevated creatine kinase, and mitochondrial dysfunction. Due~     to the negative side effects of statin therapy, additional therapies are warranted to help~     offset the effects on muscle wasting.~      Loss of muscle mass is a significant concern as it is associated with a reduction in muscle~     strength and power (Ferrando et al., 1996; Creditor, 1993). This condition is observed in~     aging, disease states, and long periods of unloading such as hospital admission and can lead~     to disability, increased falls, loss of independence, and mortality. Subsequently, there is a~     critical need to develop interventions to counteract this loss of muscle mass and strength.~     Exercise is one such intervention, however, in some cases may not be a feasible option. For~     instance, exercise has been demonstrated to exacerbate the muscle side of effects of statins.~     Subjects complain of increased muscle soreness and have elevated creatine kinase levels and~     they also do not want to take statins anymore (Kearns et al., 2008; Parker et al., 2012;~     Sinzinger et al., 2004). Because of this limitation, there is a critical need to develop~     other interventions that can prevent the loss of muscle mass during statin use.~   "
50303|NCT02908412|"~     The decision to transfuse or not to transfuse blood products is one of the main issues in~     patients undergoing surgery.~      The standard laboratory method of hemoglobin assessment is time-consuming, gives intermittent~     data, and requires venipuncture which is invasive and painful. In the past decade, the use of~     non-invasive and faster methods, which allow physicians to measure hemoglobin levels at the~     patient's bedside, have become widespread. One of the tools that make this possible is~     Spectrophotometric Hemoglobin.~      However, one of the main concerns regarding this method is its accuracy. Since the accuracy~     of this assessment depends on the extent of perfusion of the organ on which the probe is~     placed, use of digital nerve blocks proposed to increase its accuracy.~      This study aims to evaluate the effects of digital nerve block (with bupivacaine) on the~     accuracy of non-invasive hemoglobin monitoring by spectrophotometry in patients undergoing~     spinal surgery.~   "
50304|NCT02908399|"~     This is a prospective study of up to 250 participants, from birth to 18 months, who have~     already had a chest x-ray while a patient at the National Institute of Health (NICH) in~     Karachi, Pakistan. Participants will include both males and females as well as all races and~     ethnicities. Participants will have thermal pictures of their chest taken by trained study~     staff using a Smartphone and a FLIR ONE attachment. Thermal images will be read by trained~     radiologists to determine if bacterial pneumonia is present. Results of the thermal image~     will then be compared to the results of the chest x-ray. If additional images of the chest or~     other areas of suspected related infection are available, additional thermal images will be~     taken of the same location within 24 hours of the other image.~   "
50305|NCT02908386|"~     Given the lack of evidence for the benefit of particle therapy in relevant cases, he~     investigators proposed an in silico trial to investigate the dosimetric effect of contour~     changes for OAR as well as tumor during chemoradiation in H&N patients. Photon and~     proton-therapy will be compared based on dosimetric data on 7 time points during treatment~     combined with plan robustness. In that way the investigators will be able to assess and~     compare the optimal timing for replanning for photon and proton therapy.~      A database of the University of Pennsylvania (Upenn) consists of 10 patients with head and~     neck tumors treated with chemo-radiation. Contrast-enhanced CT scans were acquired prior and~     during RT (T1-T7)~   "
50306|NCT02908373|"~     The Réseau QualiSanté (risk management network) hardly works on risk management in nursing~     homes. A model to help nursing homes managers to structure and analyze adverse events has~     been constructed by a working group of health professionals in the Réseau QualiSanté. Several~     questions appeared: is the model able to increase patient safety culture of professionals~     working in nursing homes? How to characterize adverse events in nursing homes? How frequent~     are they? The main objective of this research project EHPAGE is to measure the impact of the~     model to structure and analyze adverse events in nursing homes on the patient safety culture~     of professionals. The project combines quantitative data (questionnaire) and qualitative data~     (interviews).~   "
50307|NCT02908360|"~     The prevalence of allergic diseases (atopic dermatitis, asthma, rhinitis, conjunctivitis and~     food allergy) has increased dramatically in industrialized countries over the last 20-30~     years.~      Allergic diseases are present especially in children and young adults, but all age groups are~     affected, with variations across countries and age. To propose new therapies, the~     investigators must first understand the physiopathology.~      Since their discovery the regulatory T cells have continued to be the subject of work to~     understand their role in maintaining immune homeostasis in the human body but also their~     involvement in autoimmune diseases, inflammatory diseases, transplants of solid organs or~     fluids and allergic diseases.~      It was identified two broad classes of regulatory T cells:~        -  T cells = natural regulators acquisition of a phenotype and a regulatory function right~          out of the thymus ( CD25 + / CD127 + low / FoxP3 +).~        -  T cells induced regulators = acquisition of a phenotype and a regulatory function on the~          periphery depending on the cytokine micro-environment.~      Phenotypic characterization of these is less obvious and even more so than during the last~     ten years several induced regulatory T cell populations have been described ( eg, Tr1 ).~      A new subpopulation of T cells induced in patients with inflammatory bowel disease recently~     identified have a particular phenotype as bearing the CD4 and CD8 double marking with a~     regulatory phenotype.~      These regulatory T cells are also induced a specific of a commensal intestinal bacterium~     (Faecalibacterium prausnitzii).~      Regarding allergies, it has been widely demonstrated a relationship between changes of the~     intestinal microbiota and the occurrence of allergic diseases.~      The investigators would therefore propose a cross-sectional study, single-center, controlled,~     single blinded to study the role of T cells called double positive induced regulators DP8 to~     compare the frequency and the regulatory function of specific DP8 of Faecalibacterium~     prausnitzii in atopic dermatitis, asthma and allergic rhinitis compared to control samples.~   "
50308|NCT02908347|"~     This Phase IIa study is designed to assess the safety and tolerability of oral MP1032 in~     patients with moderate to severe psoriasis over a period of 6 weeks. Secondary endpoints to~     evaluate clinical parameters for psoriasis during the 6 week treatment period and a 4-week~     follow up will provide an opportunity to perform a first assessment of oral MP1032's clinical~     efficacy in the treatment of moderate to severe psoriasis.~      The study population will consist of 44 enrolled (40 completed) patients with moderate to~     severe chronic plaque psoriasis. Patients must be able to provide written consent and meet~     all the inclusion criteria and none of the exclusion criteria.~   "
52576|NCT02878759|"~     The WristBot constitutes a comprehensive, integrated robotic system for the early diagnosis~     and rehabilitation of sensory and fine motor dysfunction to neurological or orthopedic~     disease.~   "
50311|NCT02908308|"~     ILCOR guidelines recommend Target Temperature Management (TTM) to between 32°C and 36°C after~     out-of-hospital cardiac arrest, based on low quality evidence. In a previous trial, TTM at~     33°C did not confer a survival benefit or improved neurological function, compared to TTM at~     36°C. A lower target temperature might be beneficial compared with normothermia and early~     treatment of fever. Therefore the primary purpose of the TTM2-trial will be to study any~     differences in mortality, neurological function and quality of life between a target~     temperature of 33°C and standard care avoiding fever.~   "
50312|NCT02908295|"~     Comparison of efficacy of rectal misoprostol for reduction amount of blood loss in women~     undergoing myomectomy, both open and laparoscopic approach~   "
50313|NCT02908282|"~     The primary objective of this study is to evaluate the efficacy of REMOGEN® OMEGA in reducing~     Dry Eye Syndrome (DES) symptoms.~   "
50314|NCT02908269|"~     The aim of the study was to describe the safety and immunogenicity of the 2016-2017~     formulations of Fluzone Quadrivalent vaccine in children 3 to < 9 years of age and in adults~     18 to < 65 years or age, and of the 2016-2017 formulation of Fluzone High-Dose vaccine in~     adults ≥65 years of age.~      Primary Observational Objectives~        -  To describe the safety of the 2016-2017 formulation of Fluzone Quadrivalent vaccine in~          children 3 to < 9 years of age and adults 18 to < 65 years of age, and the safety of the~          2016-2017 formulation of Fluzone High-Dose vaccine in adults ≥ 65 years of age.~      Observational Objectives:~        -  To describe the immunogenicity of the 2016-2017 formulation of Fluzone Quadrivalent~          vaccine in children 3 to < 9 years of age and adults 18 to < 65 years of age, and the~          immunogenicity of the 2016-2017 formulation of Fluzone High-Dose vaccine in adults ≥ 65~          years of age.~        -  To submit available sera from approximately 90 participants (30 participants 3 to < 9~          years of age and 30 participants 18 to < 65 years of age who receive Fluzone~          Quadrivalent vaccine, and 30 participants ≥ 65 years of age who receive Fluzone~          High-Dose vaccine) to Center for Biologics Evaluation and Research (CBER) for further~          analysis by the World Health Organization (WHO), the Centers for Disease Control and~          Prevention (CDC), and the Food and Drug Administration (FDA) to support formulation~          recommendations for subsequent influenza vaccines.~   "
50315|NCT02908256|"~     An optimal intraoperative fluid replacement reduces the hospital stay, the admissions in the~     intensive care unit and the mortality rate after a major surgery.~      Different criteria are used to guide the optimal vascular filling of a patient. Among the~     various monitoring for the last twenty years are parameters originating from the respiratory~     variations of the arterial pressure curves and the pulse oximetry.~      On arterial curves, the Systolic Pressure Variation (SPV) is the difference between the~     maximum systolic pressure (DeltaUp) and the minimal one (DeltaDown).On the oxygen saturometry~     curves obtained with the Masimo Radical7, the plethysmographic variability index (PVI)~     corresponds to the formula (PImax-PImin/PImax X 100%) where PI corresponds to the quotient~     expressed in % between the pulsed infrared absorption signal and the continuous absorption~     signal.~      It has been demonstrated that the dynamic indexes were better than the static indexes to~     determine the response to the vascular filling. A meta-analysis showed that the dynamic~     changes of the variables derived from the arterial pressure curve of patients under mechanic~     ventilation could predict the vascular filling responsiveness with a high specificity and~     sensibility. The same thing applies to the variables derived from the pulsed oxymetry curves.~      Furthermore, monitoring and minimizing, through the vascular filling, the variations of the~     pulsated arterial pressure (delta PP) induced by the mechanic ventilation during a high risk~     surgery allows to reduce the postoperative complications and the hospital length of stay.~     This has not yet been proved for the non invasive parameters (IP and PVI).~      The goal of this study is thus to compare a non invasive strategy (based on PVI) to an~     invasive strategy (based on the deltaPP) of perioperatory filling during abdomino-pelvic~     interventions (digestive, gynecologic, urologic), in order to test their equivalence and~     measure their impact in terms of hospital stay.~      This record is linked to the NCT02709252 record and share the same cohort of patients.~   "
50316|NCT02908243|"~     Primary prophylaxis in severe hemophiliacs is defined that prophylaxis therapy starts before~     2 years of age and prior to any clinically evident joint bleeding or after first joint~     bleeding and prior to the onset of joint damage irrespective of age, joints can be kept~     normal or very mildly damaged till teenage or adulthood. Primary prophylaxis has been proved~     to be more beneficial and cause less damage to joint than on-demand therapy. Primary~     prophylaxis is also known to be able to decrease the occurrence of factor VIII inhibitor and~     is the most advanced and useful, cost-effective therapy for hemophilia care. However, it~     requires 2 to 3 injections of factor VIII or IX of 20-50 IU/Kg doses every week, it costs a~     lot of expenses. In the year 2013, we tried hard to discuss with Bureau of National Health~     Insurance (BNHI) and have meeting a couple of time, eventually a guideline of an~     intermediate-dose prophylaxis for severe hemophilia was established and a consensus was~     reached that this prophylactic treatment will be cost effective without increased burden of~     total budget. This guideline was finally approved by BNHI and will be implemented from July~     1st, 2014. In oder to evaluate the efficacy of prophylaxis treatment, patients will be~     arranged to come back to each hemophilia center at least once a year to have investigation of~     doses and annual consumption of clotting factors, frequencies and causes of bleedings,~     especially joint bleedings, joint outcome by studies of hemophilia joint health score (HJHS),~     hemophilia actives list and health-related quality of life. These results will be collected~     and compared between intermediate-dose prophylaxis group of patients and on demand treatment~     group of patients.~      The life span of hemophiliacs has been improved remarkably in recent years due to sufficient~     and adequate treatments, especially prophylaxis treatment, therefore comorbidities in the~     hemophilic population, e.g. hypertension, diabetes, hyperlipidemia and cancer, etc, have been~     found with prevalences close to those in non-hemophilic population. It is worth that the~     prevalence of these comorbidity will also be investigated. In addition, basic data of the~     patients including age, sex, severity, the development of inhibitor and viral infection etc~     will also be collected for analysis.~   "
50317|NCT02908230|"~     The primary aims of this research project are to:~        1. Evaluate the efficacy of Camp NERF to improve child nutrition, physical activity, mental~          health, and anthropometric outcomes.~        2. Evaluate the efficacy of Camp NERF to improve caregiver self-efficacy for establishing~          healthy family nutrition and physical activity practices, amount of physical activity,~          and BMI.~        3. Evaluate the efficacy of Camp NERF to improve youth mentor nutrition, physical activity,~          and anthropometric outcomes.~   "
50318|NCT02908217|"~     Patients are treated with infusions of Tocilizumab (TCZ) or placebo for 5 months. Clinical~     evaluation is performed using PMR-AS.~      The PMR-AS is computed by summing the 5 variables after multiplying by 0.1 for weighting~     purposes: PMR-AS (activity scale = AS) = C reactive protein (CRP) (mg/dl) + patient scale~     (VASp) (0-10 scale) + physician scale (VASph) (0-10 scale) + morning stiffness(MST)~     [min]×0.1) + elevation of upper limbs (EUL) (0-3 scale).~      All the patients included are treated with glucocorticoid (GC).GC are reduced at each visit~     until the end of the study, depending on response to treatment and PMR-AS.~   "
50333|NCT02908022|"~     The overall aim of the present proposal is to investigate how patients' and clinicians'~     (Licensed acupuncturists, LAc) neural and autonomic processes during treatment interaction~     correlate to patient outcomes. Male and female healthy clinicians and fibromyalgia patients~     will be recruited for the study.~   "
50334|NCT02908009|"~     This is a prospective, single-center case control comparison of expression of target genes~     responsible for energy utilization, mitochondrial function and oxidative stress and levels of~     histone acetylation/ DNA methylation in obese and non-obese adult cardiac surgery patients.~   "
53284|NCT02869490|"~     Database of Institut Paoli-Calmettes patients diagnosed with cervical cancer~   "
50319|NCT02908204|"~     Tumor is the primary public health problem and the incidence of esophageal cancer showed the~     increasing trend in the past thirty years. According to the statistics in 2015, the new onset~     of esophageal cancer is about 477,900 yearly. The mainly pathologic type of esophageal cancer~     in China is esophageal squamous cell carcinomas, which accounts for more than 90% of patients~     in China. With the development of endoscopic technics, more and more patients choose to~     receive the endoscopic procedure rather than traditional surgery. However, the long-term~     efficacy and outcomes of patients with superficial esophageal squamous cell carcinoma~     received different interventions remained unclear. Thus, investigators aim to conduct a~     multi-center retrospective study to investigate the long term outcomes of superficial~     esophageal squamous cell carcinoma patients receiving endoscopic treatment and surgery.~   "
50320|NCT02908191|"~     This two-part, Phase 1 protocol will be the first clinical study of ABI-H0731. Part I will be~     a Phase 1a dose-ranging assessment of ABI-H0731 in healthy adult volunteers. If the~     dose-related safety, tolerability and pharmacokinetics (PK) of ABI-H0731 in human volunteers~     are deemed satisfactory, then the study will advance to Part II, a Phase 1b dose-ranging~     assessment of ABI-H0731 in non-cirrhotic, CHB patients.~   "
50321|NCT02908178|"~     Patients with ductal carcinoma in situ (DCIS) treated with available therapies have~     experienced excellent outcomes and very low mortality rates due to the disease's non-invasive~     nature. However, considerable debate exists as to how the DCIS lesion should be treated. As a~     result, determining strategies to manage DCIS has been identified as a research priority. The~     role of sentinel lymph node biopsy (SLNB) for DCIS management is controversial in general and~     needs further scrutiny. Our study addresses this evidence gap as the investigators propose a~     retrospective cohort study to investigate the outcome of SLNB among DCIS patients.~     Specifically, the investigators will compare the outcomes, including survival outcomes and~     treatment side effects, among women older than 67 years of age with DCIS receiving SLNB vs.~     not receiving SLNB within 6 months of DCIS diagnosis. The investigators have two primary aims~     in this study: Aim 1: the investigators select our study sample using SEER-Medicare database.~     The investigators will determine associations between SLNB and acute/subacute side effects,~     including lymphedema, pain, and limitation of movement of upper extremity from the first~     breast conserving surgery to 9 months post-diagnosis. Aim 2: the investigators will determine~     associations between SLNB and long-term outcomes, including breast cancer specific mortality,~     ipsilateral invasive breast cancer diagnosis, subsequent mastectomy as treated recurrence,~     and lasting side effects, from >9 months post-diagnosis to death or the end of this study~     period.~      Given the nature of our observational study design, the investigators will apply standard~     multivariate analyses and propensity score methodology to reduce the influence from~     confounders. The investigators will control for patient demographics, comorbidities,~     functional status, tumor characteristics, and prior healthcare utilization. Using distance to~     the nearest provider that uses SLNB for DCIS or surgeon's tendency in using SLNB for stage~     I/II breast cancer, the investigators also plan to conduct instrument variable analyses if~     necessary. Stratifying patients by key DCIS characteristics (including grade, comedonecrosis,~     and tumor size) and their predicted life expectancy (given their age and comorbidities), the~     investigators also hope to identify patient subgroups who may safely forgo SLNB. The study~     would provide evidence on the efficacy and safety outcome of SLNB for DCIS management.~   "
50322|NCT02908165|"~     The study will be a single-center, randomized Phase II study of conventional TACE in~     combination with sorafenib, given either continuously or sequentially, in patients with~     unresectable HCC. The primary variables will be tumor response (by MR Imaging) and plasma~     VEGF levels, prior to and after cTACE.~   "
50323|NCT02908152|"~     The purpose of this study is to investigate the effects of curcumin supplement on metabolic~     factors and hepatic fibrosis in nonalcoholic fatty liver patients with type 2 diabetes.~     Subjects will participate in 3 month, two group, randomized intervention, where one group~     (n=25) will take 1.5g/d curcumin and the other group (n=25) will take a placebo to compare~     differences in outcomes between the two groups.~   "
50324|NCT02908139|"~     Central blood pressure and pulse wave velocity were measured using a BR 102 Plus PWA device~     in perioperative time after kidney transplantation~   "
50325|NCT02908126|"~     This is a Phase I open-label, parallel-group clinical study in healthy term pregnant females~     undergoing a caesarean section. Two administrations of oxytocin will be tested, after which~     uterine contractility will be assessed.~   "
50326|NCT02908113|"~     We aim to increase our knowledge of the impact of preterm birth on the maturation of the~     visual and auditory systems and on the development of multisensory perception~      Specifically, we aim to evaluate the preterm infants' capabilities of detection and~     discrimination of different visual and auditory stimuli according to gestational age, post~     menstrual age and the duration of the postnatal life.~      A secondary aim is to compare this competencies in preterm and full term control art term~     equivalent age.~      The final aim is to optimize the hospital environment in order to make it correspond to the~     expectations and sensory abilities of very preterm infants.~      Our hypothesis is that preterm birth exposes the infants to numerous atypical stimuli which~     could accelerate the processes of sensory maturation~   "
50327|NCT02908100|"~     This is a multicenter, Phase II, randomized, double-blind, placebo-controlled,~     parallel-group, dose-ranging study to evaluate the safety and efficacy of GDC-0853 in~     combination with standard of care therapy in participants with moderate to severe active~     systemic lupus erythematosus (SLE).~   "
50328|NCT02908087|"~     The main objective of the trial is to study whether daily treatment with liraglutide improves~     insulin secretion and reduces the requirement of exogenous insulin, and whether liraglutide~     treatment is tolerable and safe in subjects aged 10-30 years, having an early diagnosis of~     type 1 diabetes (no symptoms, diagnosis in OGTT), and treated with insulin.~   "
50329|NCT02908074|"~     This is a 6 months, active treatment, extension study, open to subjects who have completed~     full 24 weeks in Study MBGS205 (A Phase IIb multicentre, double-blind, dose-ranging,~     randomised, placebo-controlled study evaluating safety and efficacy of BGS649 in male obese~     subjects with hypogonadotropic hypogonadism [HH]).The main purpose of Study MBGS206 is to~     evaluate long term safety and efficacy parameters in subjects after 12 months exposure with~     BGS649.~   "
50330|NCT02908061|"~     The purpose of this study is to compare any good and bad effects of using Ultrapro mesh along~     with the usual bladder removal surgery, versus having the usual bladder removal surgery~     without the use of the mesh.~   "
50331|NCT02908048|"~     The study will examine and evaluate the use of extracellular RNA in blood as markers for the~     diagnosis of liver disease or cancer, and as markers for prediction of response to treatment~     or recurrence of cancer after surgery~   "
50332|NCT02908035|"~     This is a prospective, multi-center, randomized, dose escalation study to document the~     effects of adventitial delivery of temsirolimus (Torisel) after revascularization of lesions~     below the knee in symptomatic patients with critical limb ischemia (CLI).~   "
50719|NCT02902965|"~     This is a Phase 2 open-label study to evaluate the efficacy and safety of ibrutinib in~     combination with bortezomib and dexamethasone for patients with relapsed or relapsed and~     refractory multiple myeloma.~   "
50336|NCT02907983|"~     Hot flashes and night sweats (i.e., vasomotor symptoms, VMS) affect 80% of women during the~     menopausal transition (MT). VMS are associated with decreased quality of life, increased~     depressive and anxiety symptoms, memory complaints, sleep disturbance, and reduced work~     productivity. Hormone therapy (HT) is highly effective in reducing VMS, but the use of HT~     declined 75% to 80% in the U.S. after the Women's Health Initiative (WHI) raised safety~     concerns about HT. In 2013, the Food and Drug Administration (FDA) approved paroxetine, a~     selective serotonin reuptake inhibitor (SSRI; 7.5 mg), as the first non-hormonal treatment~     for VMS. SSRIs are an important treatment option for many women, but their use in treating~     VMS is limited by lower effectiveness when compared to HT, side effects, and relapse of~     symptoms following treatment discontinuation. Identifying safe and effective non-hormonal~     treatments for VMS remains a priority in women's health research.~      Stellate ganglion blockade (SGB), used for decades in pain management, is a potential new~     approach to VMS treatment. Located in the cervical spine region, the stellate ganglia are~     part of the sympathetic nervous system. Although SGB is commonly performed to treat~     neuropathic pain, hyperhidrosis or vascular insufficiency, anatomic studies reveal~     connections between this ganglion and thermoregulatory regions of the brain, specifically the~     insular cortex.~      In this clinical trial, we aim to assess whether stellate ganglion block (SGB) with~     bupivacaine, a local anesthetic, is an effective and safe non-hormonal intervention for women~     seeking relief from vasomotor symptoms (VMS), and identify the physiologic mechanisms~     underlying SGB effects. Outcomes will include frequency and intensity of hot flashes,~     objectively-measured VMS, mood, quality of life, sleep, and memory performance in 220~     postmenopausal women with 28 or more moderate to very severe hot flashes per week as measured~     by self-report for six months. They will be reassessed at 3 and 6 months following the SGB or~     a sham intervention for objective hot flashes and quality of life measures. Mechanistic~     outcomes (neuroimaging) will be obtained at baseline and 3 months following the intervention.~     Ambulatory monitoring of sympathetic nervous system function (SKNA) will be performed at~     baseline before the procedure, during the procedure and 1 hour following the procedure. This~     will be repeated at 2 and four weeks following the SGB or sham procedure for 1 hour~     recordings.~   "
50337|NCT02907970|"~     FOSFORE study aims at identifying the barriers of cervical cancer screening in Reunion Island~     and key levers for improvment.~   "
50338|NCT02907957|"~     Regional analgesia via caudal neuraxial blockade provides pain relief for pediatric patients~     following urological and lower extremity procedures. The injection of local anesthetic into~     the caudal epidural space causes a sensory loss. This sympathetic blockade in turn causes a~     vasodilation, or increased blood flow, to the lower extremities.~      The purpose of this study is to determine whether the FLIR ONE thermographic camera, a~     smartphone attachment which utilizes an application (app) to measure the temperature at a~     site on an image of the lower extremity, will be able to differentiate between caudal,~     non-caudal, and failed caudal images.~   "
50339|NCT02907944|"~     Tobacco, alcohol and opioid use disorders threaten the health of HIV-infected patients. What~     if evidence-based counseling and medication treatments for tobacco, alcohol and opioid use~     disorders (herein refered to as addiction treatments) were routinely provided in HIV clinics?~     Implementation Facilitation is an established strategy to increase the uptake of~     evidence-based treatments. Our goal is to evaluate the impact of Implementation Facilitation~     on the use of addiction treatments in four large HIV clinics.~      The purpose of the WHAT-IF study is:~      Aim 1. Among key stakeholders, to use quantitative and qualitative (mixed) methods to~     identify the site-specific evidence, context and facilitation-related barriers and~     facilitators to the integration of addiction treatments to help tailor an Implementation~     Facilitation for each clinic.~      Aim 2. To evaluate the impact of Implementation Facilitation on:~      2a: Organizational readiness to deliver addiction treatments 2b: Provider readiness to~     deliver addiction treatments 2c: Provision of addiction treatments 2d: Changes in~     organizational models of care used to deliver addiction treatments~      Aim 3. To evaluate the impact of Implementation Facilitation on antiretroviral therapy~     receipt, HIV viral suppression, VACS Index, and retention in HIV care among patients eligible~     for addiction treatment.~   "
50340|NCT02907931|"~     Ultrasound represents an attractive non-invasive method to assess hemodynamic status.~     Understanding dynamic changes in hemodynamics in situations such as hypovolemia, sepsis, and~     cardiogenic shock can potentially help improve patient care. However, the inter-rater~     reliability and accuracy of how various ultrasound measurements reflect dynamic changes in~     physiology remains incompletely understood. Overall our aims are to investigate the use of~     ultrasound in a controlled setting, specifically using lower body negative pressure (LBNP),~     which can simulate hypovolemia at varied levels in human volunteers.~      Aim 1: To determine the change in carotid blood flow (measured by velocity time integral,~     VTI) in subjects undergoing simulated hypovolemia at LBNP levels that precede vital sign~     changes.~      Hypothesis: Carotid VTI will demonstrate significant changes that precede vital sign changes~     in simulated hypovolemia.~      Aim 2: To compare transcranial color Doppler indices of cerebral blood flow with carotid~     blood flow, as assessed by VTI of the common carotid artery.~      Hypothesis: Changes in transcranial color Doppler indices of cerebral blood flow will be~     mirrored by changes in carotid blood flow, indicating carotid VTI is an adequate surrogate~     for measuring cerebral blood flow in variable states of central hypovolemia. However, if~     cerebral blood flow remains more constant than carotid blood flow throughout varying levels~     of hypovolemia, our assumption is that cerebral autoregulation alters the relationship~     between carotid and cerebral blood flow. The more complex procedure of Transcranial Doppler~     ultrasound (TCD) must be performed to obtain valid assessments of cerebral blood flow.~   "
50341|NCT02907918|"~     The investigators propose to influence estrogen receptor (ER) signaling by combining~     endocrine therapy with CDK4/6 inhibition along with trastuzumab in ER+/ human epidermal~     growth factor receptor 2 (HER2)+ early stage breast cancer.~   "
50342|NCT02907905|"~     Social insecurity is a significant cost in human terms (health and societal), it defines evil~     and can be identified as difficulties accessing health and especially water.~      We chose to take stock of these populations defined by difficulties accessing water as~     precarious setting. Subjects homeless population fall into this by accident of life, a life~     homeless or migrant subjects often illegally having only transitory access (associative or~     charitable structures host) the conditions precarious sanitation including drinking water or~     toilet. Populations of slums in the same conditions or the presence rationed water (one tap~     for 150 people) restricts hygiene.~   "
50343|NCT02907892|"~     A randomized controlled trial to determine whether changing of gloves by the surgical team~     during cesarean section may decrease post-operative infectious morbidity and wound~     complications~   "
50344|NCT02907879|"~     The objective of the study is to assess brain tissue perfusion by ultrasound perfusion~     imaging. Specifically~        -  to diagnose brain tissue hypoperfusion due to CVS with contrast enhanced UPI and to~          assess specificity and sensitivity, and predictive values for detection of brain tissue~          hypoperfusion leading to infarction~        -  to test whether treatment-effects by induced hypertension, balloon-dilatation, or~          intra-arterial nimodipine infusion can be detected and quantified by UPI~   "
50345|NCT02907866|"~     Endobronchial ultrasound (EBUS) is a technique that uses ultrasound along with bronchoscope~     to visualize airway wall and structures adjacent to it. Pneumothorax is a known complication~     from EBUS procedure. To rule out a Pneumothorax after the procedure, a Chest -X-ray is~     usually done. Point-of-care sonography has emerged as an invaluable tool in the assessment of~     patients with both traumatic and non-traumatic dyspnea. Multiple studies involving bedside~     ultrasound has shown that a pneumothorax can easily be ruled out if pleural sliding sign or B~     lines are visualized on lung ultrasonography; the accuracy of lung ultrasound in ruling out~     pneumothorax approach computed tomography and exceed plain radiography. Preforming a lung~     ultrasound using the EBUS bronchoscope tip as a way to rule out pneumothorax has never been~     described previously. If this is possible it will obviate the need of getting a Chest -X-ray~     and decrease the dose of radiation that the patient is exposed to. In this study we will~     demonstrate that the feasibility of using the transducer of the EBUS Bronchoscope to perform~     bedside lung ultrasound to rule out pneumothorax.~   "
50346|NCT02907853|"~     This study will link findings from neuroscience with clinical outcomes using contingency~     management (CM) to identify changes in brain structure and function that emerge during purely~     behavioral therapy for methamphetamine (MA) use.~   "
50347|NCT02907840|"~     The study will explore the possibility to predict potential for recruitment in acute~     hypoxemic respiratory failure patients by electrical impedance tomography (EIT) Swisstom BB2~     (Swisstom, Landquart, Switzerland) during stepwise increase in positive end-expiratory~     pressure (PEEP) followed by recruitment maneuver (RM). It will compare data obtained by EIT~     to those obtained by pressure-volume (P-V) curves on respiratory system mechanics and data on~     pulmonary gas exchange.~   "
50348|NCT02907827|"~     Patients with locally advanced melanoma are at high risk for recurrence following surgical~     treatment. More patients with stage IV melanoma remain in complete remission following~     systemic therapy. No standards have been established for the surveillance of patients at high~     risk for recurrence. Whole-body diffusion-weighted magnetic resonance imaging and cfDNA~     analysis of blood are innovative imaging and laboratory investigations that may be of benefit~     for early detection of recurrence in this patient population.~   "
50349|NCT02907814|"~     Optical Coherence Tomography (OCT) is routinely used in ophthalmic clinical practice. It uses~     infrared light to image patient's eyes. Some patients, such as those with an inflammatory~     disease called uveitis or those who have just undergone cataract surgery, have intraocular~     inflammation. This intraocular inflammation commonly manifests as cells that can be seen on~     routine microscopic clinical examination. However, the only currently available method to~     quantify this intraocular inflammation is by manually counting on the microscopic clinical~     examination. The investigators plan to use the OCT machine to image patient's eyes. The~     investigators will then use the images obtained from the OCT to objectively quantify the~     degree of intraocular inflammation.~   "
50350|NCT02907801|"~     Infants with congenital muscular torticollis (CMT) display postural and functional asymmetry~     that interferes with their development. The use of the Perception-Action Approach (P-AA)~     intervention in infants with CMT is supported by a single case report and needs to be~     researched further to determine its efficacy. This study will investigate the immediate~     effects of the P-AA intervention on habitual head deviation from midline, active head~     rotation range of motion, and functional use of both sides of the body in infants with CMT.~      The participants will be 3 infants with CMT, aged birth to 9 months. A randomized,~     nonconcurrent A-B multiple baseline design across subjects will be used. The intervention~     phase will include 5 daily PT sessions, with outcome data collected at the end of each~     session.~      It is hypothesized that improvements on all outcome measures will be documented upon the~     initiation of the P-A Approach intervention, with the most substantial change expected in~     habitual head deviation from midline measured by still photography.~   "
50351|NCT02907788|"~     Airway disease, featuring intense inflammation, is the main cause of morbidity and mortality~     in cystic fibrosis (CF). Mechanisms of CF airway inflammation remain unclear, hampering~     development of better treatments.This time-sensitive ancillary study leverages a unique~     longitudinal cohort of CF infants, assessing the early phase of airway disease. Through the~     use of innovative cell and fluid based tools for in vivo profiling and in vitro testing of~     BALF samples, this translational effort will yield unprecedented insights into mechanisms of~     PMN dysfunction in CF, and assess new paths for early intervention.~   "
50352|NCT02907775|"~     Over 87,000 people have a first stroke in the UK each year; about 70% of victims have altered~     arm function and about 40% are left with a non-functional arm. Spasticity is a significant~     deterrent for recovery of arm function following stroke. One in four patients develop~     spasticity within the first 2 weeks of the stroke and by 12 months 39 % have spasticity. The~     use of oral antispasticity medications like baclofen and tizanidine are often restricted due~     to side effects like sedation, weakness and floppiness. Compliance of adults to treatment~     with oral anti spasticity drugs is only around 50%.~      There are a few exploratory studies on sensory stimulation using Transcutaneous Electrical~     Nerve Stimulation (TENS) in reducing spasticity. Amatya et al reviewed the evidence and~     concluded that there was not sufficient evidence to recommend its routine use. One possible~     explanation for the ineffectiveness of TENS is that it uses a single channel, single strength~     and fixed duration stimulation to which the nervous system may get habituated. We have~     developed Shefstim; a unique miniaturised 64 channel electrical stimulator. Using Shefstim we~     pioneered a technique called Sensory Barrage Stimulation ;rapid simultaneous stimulation at~     multiple sites, in a constantly changing pattern. We hypothesise that this approach will~     significantly reduce habituation compared to single site stimulation, thus providing a better~     treatment for spasticity.~      Objective of the proposed study is to to explore the feasibility of conducting a community~     based randomised cross over trial comparing SBS with TENS for post stroke upper limb the~     spasticity of elbow flexors to optimise the stimulation parameters through quantifying~     objectively the muscular response to two different stimulation protocols.~   "
50353|NCT02907762|"~     The First In Human (FIH) study is a long-term, single center, non-randomized study~     established by Lombard Medical, Inc. to collect on-label data in the clinical setting on~     patients undergoing endovascular repair with IntelliFlex™, the latest generation of the~     Aorfix™ AAA Flexible Stent Graft Delivery System, for treatment of abdominal aortic and~     aorto-iliac aneurysms in anatomy where the aorta in the aneurysm neck is bent through an~     angle between 0° and 90°.~   "
50354|NCT02907749|"~     The aim of this study is to investigate the effects of spironolactone on liver fibrosis~     progression and portal hypertension in patients with compensated cirrhosis. The patients were~     nonrandomized according to the medical conditions determined by the physicians, in 3 arms~     (spironolactone start from 40mg once daily and increase every week with a maximum dose as~     100mg once daily, carvedilol start from 6.25mg once daily and increase to 12.5mg once daily~     in next week if being tolerated, spironolactone in combination with carvedilol:~     spironolactone is added when carvedilol has reached the most tolerated dose). Portal pressure~     gradient by virtual hepatic venous pressure gradients based on enhanced CT, and liver~     elasticity by Fibroscan Medical Device are documented at baseline level and every six months~     after the treatment. Changes in serum fibrosis markers and liver function are monitored~     before and every 3 months after the treatment.~   "
50355|NCT02907736|"~     Acute Ischemic stroke (AIS) remains a leading cause of adult disability, cognitive impairment~     and mortality worldwide despite the development of revascularization therapies (intravenous~     Tissue Plasminogen Activator (t-PA) and endovascular therapy). Thrombosis resistance after IV~     t-PA therapy is frequent especially in case of AIS with proximal occlusion. In recent years,~     neutrophil extracellular traps (NETs) have been identified as major triggers and structural~     factors of various forms of thrombosis. NETs are extracellular webs primarily composed of DNA~     from neutrophils. A recent study shows that the NETs burden in coronary thrombi is positively~     correlated with the infarct size and negatively correlated with electrocardiogram~     (ST-segment) resolution. This later study revealed that in vitro addition of DNase I~     accelerated the t-PA-induced thrombolysis of coronary thrombi. NETs could, in consequence, be~     promising targets for improved thrombolysis in AIS.~      The aim of this study is to assess the impact of NETs composition of thrombi retrieved during~     endovascular therapy in AIS patients on IV t-PA induced thrombolysis, clinical outcome and~     AIS etiologies.~   "
50356|NCT02907723|"~     This pilot study aims to assess a new device designed for an objective measure of sleep~     parameters. The purpose of the device is to assess, in a more simple and precise way, the~     impact of deep brain stimulation on patient's sleep.~   "
50357|NCT02907710|"~     A total of 300 patients with pathologically confirmed Locoregionally advanced nasopharyngeal~     carcinoma were enrolled. Patients were randomly divided into two groups, with 150 patients in~     each group. One group was treated with Concurrent Chemoradiotherapy combined with Endostar~     and the other group was treated with Concurrent Chemoradiotherapy. The short term efficacy~     and the toxic and side effects of these treatments were evaluated. The 1-year, 3-year, 5-year~     overall survival and progression-free survival of patients were analyzed. The investigators~     data may provide an alternative option for the treatment of Locoregionally advanced~     nasopharyngeal carcinoma with high efficacy and low toxicity.~   "
50358|NCT02907697|"~     Many people living with HIV use illicit drugs, which leads to worsened health outcomes and~     increased transmission of HIV due to poor adherence to medication regimens. This research~     will develop an intervention targeting medication adherence that is tailored to the unique~     needs of HIV-infected drug users. This research will promote adherence and improve treatment~     outcomes among HIV-infected drug users thereby minimizing the development of drug resistant~     strains of HIV and reducing transmission.~   "
50359|NCT02907684|"~     The purpose of this study is to investigate the cardio-metabolic health effects of consuming~     almond nuts in place of habitual (usual) snack products in adults at moderate risk of~     developing cardiovascular disease~   "
50360|NCT02907671|"~     Effectiveness of ultrasound guided corticoanesthetic injection in carpal tunnel syndrome~     treatment comparing two different injection sites. Single-blind randomized trial.~   "
50361|NCT02907658|"~     Background. The reduction of prevalence rates of Internet Use Disorder (IUD) and its~     effective treatment are at high priority in both public health and educational policies.~     School-based preventive interventions facilitate a low-threshold approach for individuals~     with IUD, who are typically characterized by high therapy avoidance. Moreover, indicated~     approaches which target adolescents at high-risk show larger effects than universal~     prevention approaches. Simultaneously, they reduce unnecessary burden for the majority of~     high-school students that is not at-risk. The PROTECT intervention for indicated prevention~     of IUD in school settings was developed based on these preventive strategies.~      Methods. Three-hundred and forty adolescents, aged 12-18 years, from 40 secondary schools in~     Germany, screened for high-risk of IUD onset, will be randomly assigned to a) PROTECT~     intervention group or b) assessment only control group. The tested intervention consists of a~     cognitive-behavioral 4-session brief-protocol. Follow-up assessments are at 1, 4 and 12~     months after admission. Primary outcome is the 12-months incidence rate of IUD. Secondary~     outcomes are the reduction of IUD and comorbid symptoms and the promotion of problem solving,~     cognitive restructuring and emotion regulation skills.~      Discussion. The indicated preventive intervention PROTECT follows the APA-guidelines for~     psychological prevention. It is theory- and evidence-based (guideline 1) and addresses both~     risk-reduction and strength-promotion (guideline 3), it considers current research and~     epidemiology (guideline 4) and ethical standards (guideline 5) such as professional secrecy~     and is designed as a systemic intervention (guideline 8) at the school-level. It is expected~     that the intervention decreases risk of IUD onset (incidence rate).~   "
50362|NCT02907645|"~     Influenza vaccine is recommended as routine care for all individuals who are at least 6~     months of age and older. Recently, questions about vaccine safety and concerns for side~     effects have increased, contributing to both influenza vaccine hesitancy and refusal. In an~     effort to educate patients, public health entities and physicians give informational handouts~     in various forms.~      However, recent publications have found that pro-vaccine messages can have paradoxical~     effects on vaccine intentions, therefore further studies on vaccine related public health~     communication is needed. The purpose of this study is to compare the effectiveness of~     pro-vaccine messages of local data, pro-vaccine messages of national data, and no educational~     message on patient's receipt of the influenza vaccine. These results will help to understand~     the relationship between patient education and the intent to vaccinate and receipt of the~     influenza vaccine as well as to optimize educational information given to patients regarding~     the influenza vaccine.~   "
50610|NCT02904395|"~     Given the 100 fold increase of the incidence of Pompe's disease in Western French Guiana, the~     objective of the present study is to implement systematic screening in newborns in French~     Guiana in order to start treatment before the muscular and cardiac symptoms appear.~   "
50363|NCT02907632|"~     Gastroesophageal Reflux (GER) is a condition that affects the majority of premature infants~     that are followed at the Kangaroo Mother Care Program (ambulatory program for preterm infants~     discharged with their mothers in continuous skin to skin contact and strict outpatient follow~     up). For over 20 years, the use of Metoclopramide has been systematic among all preterm~     infants according to the protocols of the Kangaroo Mother Care (KMC) Program . The aim of~     this clinical trial is to evaluate the effectiveness and security of metoclopramide to lessen~     the symptoms of GRE in premature infants that are followed and treated in the Ambulatory KMC~     Program before 40 weeks of gestational age. Design: Randomized, double blind trial,~     controlled with placebo. Eligible Population: Premature infants that are followed and treated~     in the Ambulatory Kangaroo Mother Care Program at Hospital Universitario San Ignacio before~     40 weeks of gestational age, which systematically receive: metoclopramide 0.2 mg per kg,~     every 8 hours, 15 minutes before every feeding up to 40 weeks of gestational age, between~     January 01 2017 and December 31 2017.Outcomes: Incidence of regurgitation episodes reported~     by the parents of the infants, episodes of apnea, bronchoaspiration, postprandial~     irritability, the infant rejects feeding, alteration in the postprandial posture and the~     frequency and severity of adverse effects associated with the use of Metoclopramide such as~     extrapyramidal symptoms and sedation. In the case of continuous variables, the mean and~     median will be compared according to the distribution and for nominal variables, a chi~     squared test or fisher test will be carried out.~      Duration: 12 months. Ethical Aspects: Experiment with minimum mayor risk. Informed consent~     will be requested to parents. An independent committee from the work group will be in charge~     of carrying out the follow-up of the safety and progression of the study. A methodological~     expert, a thematic expert, a statistician and an expert in bioethics will constitute the~     committee.~      Financial Disclosure: The study will be funded through the Kangaroo Foundation with the~     collaboration of the  Hospital Universitario San Ignacio, Bogotá, Colombia.~   "
50364|NCT02907619|"~     This study is an open-label extension to protocol B5161002 and will provide an assessment of~     the long term safety, efficacy, pharmacodynamics and pharmacokinetics of intravenous dosing~     of PF 06252616 in boys with Duchenne muscular dystrophy. Approximately 105 eligible subjects~     will be assigned to receive a monthly individualized maximum tolerated dose based on their~     tolerability profile/data from B5161002. This study will not contain a placebo comparator.~     Subjects will undergo safety evaluations (Laboratory, cardiac monitoring, physical exams,~     x-ray, MRI), functional capacity evaluations (4 stair climb, range of motion, strength~     testing, Northstar Ambulatory Assessment, upper limb functional testing, six minute walk test~     and pulmonary function tests) and pharmacokinetic testing.~   "
50365|NCT02907606|"~     This study will evaluate the feasibility and effectiveness of urinary ctDNA detection and~     dynamic monitoring during treatment of NSCLC patients prospectively,by collecting and~     detecting tumor tissues, peripheral blood samples and urine samples of NSCLC patients.~   "
50366|NCT02907593|"~     This is a phase I/II open-label study to determine the lowest, safe, effective dose of~     budesonide given with calfactant as the vehicle.~   "
50367|NCT02907580|"~     Influenza vaccine is recommended as routine care for all individuals who are at least 6~     months of age and older. Recently, questions about vaccine safety and concerns for side~     effects have increased, contributing to both influenza vaccine hesitancy and refusal. In an~     effort to educate parents and patients, public health entities and physicians give~     informational handouts in various forms. However, recent publications have found that~     pro-vaccine messages can have paradoxical effects on vaccine intentions, therefore further~     studies on vaccine related public health communication is needed. Few, if any, studies have~     analyzed the relationship between influenza vaccine attitudes and intention with actual~     vaccine receipt in the pediatric population. These results will help to understand the~     relationship between parent's vaccine perception and the intent to vaccinate versus the~     child's receipt of the influenza vaccine, as well as to optimize educational information~     given to families regarding the influenza vaccine.~   "
50368|NCT02907567|"~     This is a multi-center, randomized, double-blind, placebo-controlled, parallel group study of~     two doses of CT1812 in adults with mild to moderate Alzheimer's Disease to evaluate the~     safety and tolerability of oral CT1812, administered for 28 days. This trial may include up~     to 8 qualified investigator sites in Australia.~   "
50369|NCT02907554|"~     Organ donors included in the study are randomized to a control group or an intervention group~     receiving 2.5 mg/kg of cyclosporine A before organ procurement. Harvested kidneys from these~     patients are transplanted to chronic kidney insufficiency patients. According to the~     pretreatment of the transplant, delayed graft function during the first week was evaluated as~     well as kidney function at different timepoints and mortality during the first year after~     transplantation.~   "
50370|NCT02907541|"~     This study evaluates the use of eLearning of quality improvement methods. Participants who~     use eLearning only, facilitated learning only and a combination of eLearning and facilitated~     learning will complete questionnaires and be interviewed to establish the effect of eLearning~     of quality improvement methods to improve knowledge, change in behaviour and impact on~     healthcare services for better patient care.~   "
50371|NCT02907528|"~     Objective: To clinically evaluate mandibular furcation treated with Beta tricalcium~     phosphate/hydroxyapatite (βTCP/HA) isolated or combined with enamel matrix derivative (EMD +~     βTCP/HA) and EMD alone.~      Material and Methods: 39 patients, presenting at least one mandibular class II furcation~     defect, probing pocket depth (PPD) ≥ 4 mm and bleeding on probing, were included. The defects~     were assigned to the βTCP/HA group 1 (n = 13); open-flap debridement (OFD) + βTCP/HA filling;~     βTCP/HA + EMD group 2 (n = 13); OFD + βTCP/HA + EMD filling; and EMD group 3 (n = 13) OFD +~     EMD filling. Plaque (PI) and gingival index (GI), PPD, relative gingival margin position~     (RGMP), vertical and horizontal attachment level (RVCAL and RHCAL), and furcation diagnosis~     were evaluated at baseline, 6 and 12 months.~   "
50372|NCT02907515|"~     The single implant overdenture (IOD) represent the simplest form of IODs compared to the 2~     IOD which is the traditional gold standard IOD treatment option. Mandibular single-implant~     overdentures are proven to be a successful treatment option for older edentulous adults but~     we need to know if the CM-LOC attachment will retain its superiority over the ball~     attachments intraorally regarding the prosthetic complications in single implant retained~     overdenture like in 2 IOD~   "
50373|NCT02907502|"~     To assess growth of children (enrolled between 11.5 and 13.5 months) fed with two~     iso-energetic, young-child formulas with different protein content during the second year of~     life~   "
50374|NCT02907489|"~     The purpose of this study is to determine whether the use of triple antibiotic paste as~     intracanal medication with an anti-inflammatory drug, compared to a calcium hydroxide will~     reduce postoperative pain and intracanal bacteria or not in patients with asymptomatic~     necrotic teeth.~   "
50731|NCT02902809|"~     A 52-Week, Open-Label, Multicentre Study to Evaluate the Safety of Tralokinumab in Japanese~     Adults and Adolescents with Asthma Inadequately Controlled on Inhaled Corticosteroid plus~     Long-Acting β2-Agonist~   "
50375|NCT02907476|"~     This randomized controlled trial is designed to test the Vagal-gamma amino-butyric acid~     (GABA) Hypothesis that one of the mechanisms by which yoga-based practices improve mood and~     decrease anxiety is by correcting an autonomic system (ANS) imbalance with too much activity~     in the sympathetic nervous system (SNS) and too little activity in the parasympathetic~     nervous system (PNS). This imbalance is associated with under activity in the GABA system. It~     is hypothesized that yoga-based practices increase activity in the PNS by increasing~     respiratory sinus arrhythmia (RSA), which is associated with increased activity in the GABA~     system and decreased depressive and anxiety symptoms.~   "
50376|NCT02907463|"~     The purpose of this active, observational, open-label, non-randomized, post-market~     surveillance study is to confirm that EDWARDS INTUITY Elite reduces cross clamp time (XCT) in~     MIS setting when compared to published data with a conventional valve within the MIS setting.~     The published dataset will used as a control group. Then to describe short term (30 days) and~     long term (6 months) clinical safety, to assess and compare hemodynamic data with EDWARDS~     INTUITY Elite to a conventional valve at discharge and at 6 months post AVR, to assess~     Quality of Life at baseline, and at 6 months post AVR to assess NYHA functional class at~     baseline, discharge, 1 month and at 6 months post AVR to assess Fitness for hospital~     discharge.~   "
50377|NCT02907450|"~     The TwiCare® device is a removable brace that can be used in orthopedic referred to stimulate~     mandibular growth or in interception / contention.~      The proposed research project will focus initially on assessing the comfort and safety of~     TwiCare® device. The orthopedic efficiency therefore not part of this study.~      The comfort and safety of the brace will be evaluated firstly by the practitioner during the~     visit control around 2 ½ months (or 11 weeks) after the start of the port of the device, and~     with the help of a questionnaire completed by the patient at home 3 weeks and 6 weeks after~     the start of the port of the device, and during the control visit at 11 weeks.~   "
50378|NCT02907437|"~     Current medications have only a limited effect on two core symptoms of schizophrenia,~     negative symptoms and cognitive deficits. Minocycline is a second-generation tetracycline~     which has a beneficial effect in various neurological disorders. In the past years, various~     findings from clinical studies showed its potential role for the treatment of these symptoms~     of schizophrenia. The current study aims to examine the efficacy of minocycline as add-on~     treatment for alleviating positive, negative and cognitive symptoms in schizophrenia~     patients.The current study is a single center, double-blind, randomized study that assess the~     adjuvant therapeutic effect of minocycline vs. placebo added to antipsychotic medications, in~     adult patients suffering from schizophrenia. Patients will be recruited and randomly~     allocated to a minocycline or placebo treatment (200 mg/day) for 6 weeks of treatment. In~     addition, all patients will receive probiotics (450mg/day) in order to prevent any~     gastrointestinal influences of antibiotics administration. Positive and negative symptoms ,~     as well as cognitive functions will be assessed before and after treatment.~   "
50379|NCT02907424|"~     In order to make Cambodia independent from importing a product for the treatment and~     prevention of malnutrition, UNICEF, DFPTQ Fisheries Administration and IRD have started a~     collaboration for the development of a range of products for the treatment and prevention of~     malnutrition. To reduce costs of the product, and to adapt the taste to local circumstances,~     the protein source of the usual RUTF (milk powder) has been changed to fish (Trey Riel). The~     main objective of this sub-study is to test the efficacy of the newly developed RUTF on the~     recovery of children suffering from severe acute malnutrition. As comparison, the current~     treatment of SAM with BP-100 will be used.~   "
50380|NCT02907411|"~     Quad Rivas Therapy has been developed by Alyna Eekma from the Netherlands for over thirteen~     years; anecdotally she has been able to significantly reduce lipedema SAT in women with Stage~     1 and 2 lipedema, and can reduce lipedema SAT by 80% in women with Stage 3 lipedema. The~     study will last for one month, for a total of 12 treatments per subject, seven subjects~     total, to see if there is a change in percent body fat percentage over the course of these~     treatments.~   "
50381|NCT02907398|"~     Inspire intends to conduct this registry to: 1) collect Inspire therapy clinical evidence in~     the clinical practice setting; 2) collect additional information on the effectiveness, use~     and safety in the commercial setting; and 3) engage physician customers to report the~     collective outcome within a group of properly trained programs that utilize Inspire therapy~     on a regular basis.~      In addition, a sub-study will be conducted under this Registry at a limited number of~     Registry centers and will include a cohort of Registry patients and a cohort of patients who~     have not received the Inspire therapy device due to denial of insurance coverage. The two~     sub-study cohorts' quality of life and AHI data will be compared.~   "
50382|NCT02907385|"~     LifeSeal™ Kit, surgical sealant designed for staple-line reinforcement that is applied over~     the anastomotic line to prevent bowel content leakage until full physiological function is~     restored.~      RATIONALE : Postoperative anastomotic leakage is one of the most devastating and feared~     complications in colorectal surgery. The risk of postoperative anastomotic leakage varies~     widely depending on the level of anastomosis while the risk is higher in low anastomosis.~      In order to best demonstrate the benefits of LifeSeal™ in providing staple line reinforcement~     and helping to reduce leaks, the study includes high risk anastomoses, defined as colorectal~     and coloanal anastomoses performed within 10 cm from the anal verge.~      STUDY DESIGN: This study is designed as a prospective, multi-center, multinational~     randomized, single-blind, double armed study PRIMARY OBJECTIVE: The primary objective of this~     study is to assess the efficacy and safety of LifeSeal™ Kit as measured by the change in~     overall anastomotic leak rates in subjects undergoing low anterior resection with an~     anastomosis below 10 cm from the anal verge, over the first 17 weeks after surgery.~      SECONDARY OBJECTIVES: The secondary objective of this study is to assess the incidence of~     post-operative leaks and additional benefits that could be related to the use of LifeSeal™~     Kit such as reducing the severity and improving the outcome of a leak once it has occurred.~     In addition, the study will allow for collection and analysis of additional safety data and~     usability assessment of the device, medical resource utilization, and health related quality~     of life measures.~   "
50383|NCT02907372|"~     This study will assess the impact of the novel oral hormonal agents (abiraterone acetate or~     enzalutamide) among elderly metastatic prostate cancer patients. This study will assess the~     influence of treatments on patients' cognitive functions on a longitudinal basis and evaluate~     the quality of life and the adherence of patients who had or develop cognitive disorders.~   "
50384|NCT02907359|"~     A Phase 3, randomized, open-label, parallel-group, multicenter study designed to evaluate the~     efficacy and safety of guadecitabine in subjects with MDS or CMML who failed or relapsed~     after adequate prior treatment with azacitidine, decitabine, or both. This global study will~     be conducted in approximately 15 countries. Approximately 408 subjects from approximately 100~     study centers will be randomly assigned in a 2:1 ratio to either guadecitabine (approximately~     272 subjects) or Treatment Choice (approximately 136 subjects). The study consists of a~     14-day screening period, a treatment period, a safety follow-up visit, and a long-term~     follow-up period. The study is expected to last more than 2 years, and the duration of~     individual subject participation will vary. Subjects may continue to receive treatment for as~     long as they continue to benefit.~   "
50385|NCT02907346|"~     The purpose of this pilot project is to evaluate the effectiveness of a behavioral economic~     intervention to increase use of continuous glucose monitors (CGM) in adolescents and young~     adults with T1D. This study will be done in conjunction with Nancy Petry, PhD and her~     research team at University of Connecticut School of Medicine (UConn Health). The~     intervention will reinforce patients for wearing CGM and for uploading it and reviewing its~     data. A 6-month pilot trial will be conducted with up to 20 patients receiving the~     intervention. The specific aims are:~   "
50386|NCT02907333|"~     Women who are diagnosed with CIN2 and who have a pregnancy wish are followed up 3-6 months~     after the diagnosis with new examinations. The regression rate is based solely on the woman's~     own ability to clear the cervical lesions. The use of condoms has shown a relatively good~     protective effect against Human Papillomavirus (HPV) infection. It has furthermore been~     indicated that condoms increase the regression rate of cervical lesions.~      The hypothesis of this study is that the regression rate of cervical intraepithelial~     neoplasia grade 2 (CIN2) increases when condoms are used consistently in the follow-up period~     of 3-6 months.~   "
50387|NCT02907320|"~     Chronic Venous Disorder is the most prevalent vascular disease. It is multifactorial~     pathology that has an important impact on quality of life and represents a significant public~     health concern, due to its very high frequency in all European and American (north and south)~     countries.~      Venous pathology develops when venous pressure is increased and return of blood is impaired~     through several mechanisms. Wish induce leg symptoms (tingling, aching, burning, pain, muscle~     cramps, sensation of swelling, sensations of throbbing or heaviness, itching skin, restless~     legs, leg tiredness and/or fatigue.~      The aims of this research is to study the effects on microcirculatory activity (activity on~     very small vessels) of CYCLO 3 ® FORT, MPFF (Micronised Purified Flavonoid Fraction) and~     Placebo after 8 week of treatment by Microscan, and Duplex, two imaging non-invasive~     technologies will be performed to obtain measurements of microcirculatory parameters in~     standardized and reproducible conditions for all the participants. In addition, will assess,~     in blood samples, the inflammatory biomarkers .~   "
50388|NCT02907307|"~     The purpose of this study is to compare the efficacy and safety of LactiSal 1%vaginal gel and~     LactiSal 50 mg vaginal tablet with the standart treatment of clotrimazole 100 mg vaginal~     tablet in woman with vulvovaginal candidiasis (VVC)~   "
50389|NCT02907294|"~     To assess the safety and tolerability of five doses of PBF-999 (160 mg and 320mg) after~     repeated (8 days) single daily oral dose administration in young male and female healthy~     subjects.~   "
50390|NCT02907281|"~     This is a 3-year, pharmacologically non-interventional study to evaluate OCT as an outcome~     measure in patients with relapsing remitting multiple sclerosis (RRMS).~      Approximately 350 RRMS patients, either untreated or treated with an approved MS~     disease-modifying therapy and approximately 70 reference subjects without ophthalmologic or~     neurologic disease are enrolled. No study medications are provided. Patients on~     disease-modifying therapy are treated according to the local prescribing information. For~     each MS patient and each reference subject, the study consists of Screening (up to 1 month),~     Baseline, and a 36-month longitudinal data collection phase. Eligibility will be confirmed~     during Screening.~   "
50391|NCT02907268|"~     A 16-week single-blind, split-face, randomized study. Each patient served as their own~     control, receiving onabotulinumtoxinA and abobotulinumtoxinA randomized to either the left or~     right side of the face. Patients received intradermal BTXA injections at week 0 and~     intramuscular BTXA injections at week 2. The objective is to examine the effectiveness of~     intradermal botulinum toxin type A (BTXA) injection in improving skin texture and midface~     lift while reducing pore size and sebum production, as well as investigate the differences in~     effectiveness between onabotulinumtoxinA and abobotulinumtoxinA using intradermal and~     intramuscular injection methods.~   "
50392|NCT02907255|"~     Patients are at risk of respiratory depression after having surgery. The medications that~     patients are treated with to control their pain can impair their breathing and this can~     progress to respiratory and cardiac arrest and even death. Vital signs assessment on surgical~     wards is usually done every 4 hours and this may be insufficient to identify and manage many~     cases of respiratory depression. The aim of this study is to determine the impact on safety~     and nursing workflow of a respiratory monitoring on two surgical wards by measuring safety~     outcomes. Respiratory depression is a serious complication of pain treatment that can lead to~     patient complications and death. The level of monitoring available in hospitals by nursing~     staff is insufficient to manage this problem. If this new monitoring technology works as~     designed then patient safety can be improved while maintaining effective pain therapy.~   "
50393|NCT02907242|"~     The purpose of this study is to evaluate the role of an integrated strategy at selecting~     fetuses for delivery at term based on a combination of fetal biometry and cerebroplacental~     ratio (CPR) to reduce stillbirth rate and adverse perinatal outcome.~   "
50394|NCT02907229|"~     This trial is conducted to evaluate the safety and technical effectiveness of using NCVC-CS1,~     a newly developed honeycomb microporous covered stent, for the treatment of intracranial~     aneurysms which are difficult to be cured by conventional surgical or endovascular~     procedures.~   "
50459|NCT02906371|"~     This is a two cohort, open-label, pilot study to describe the efficacy of administration~     timing of tocilizumab on CART19 (CTL019) associated cytokine release syndrome safety events~     in pediatric patients with CD19 expressing relapsed and refractory B-cell acute lymphoblastic~     leukemia with high versus low pre-infusion tumor burden following redirected autologous T~     cells transduced with the anti-CD19 lentiviral vector (CART19/CTL019).~   "
53285|NCT02869477|"~     Database of Institut Paoli-Calmettes patients diagnosed with cardia cancer~   "
50395|NCT02907216|"~     The purpose of this study is to evaluate the immunogenicity and safety of the diphtheria,~     tetanus, pertussis and inactivated poliovirus (DPT-IPV) vaccine Squarekids administered with~     or without the GSK Biologicals' liquid Rotarix (HRV) vaccine, in healthy Japanese infants~     aged 6 - 12 weeks. GSK Biologicals' liquid HRV vaccine Rotarix is licensed in Japan since~     2011. Although the concomitant administration of GSK Biologicals' DTP-IPV vaccine has been~     evaluated during the clinical development of the HRV vaccine, the vaccine differed in~     composition and route of administration from the DPT-IPV vaccine Squarekids manufactured in~     Japan. Hence, as requested by the Japanese regulatory authorities, this post-licensure study~     will evaluate the immunogenicity of the DPT-IPV vaccine manufactured in Japan when~     co-administered with the liquid HRV vaccine~   "
50396|NCT02907190|"~     The objective of this study is to compare the glycemic and insulinemic response elicited by ½~     cup servings of 6 beans to those elicited by ½ cup servings of mashed potato, macaroni, rice~     and corn.~   "
50397|NCT02907177|"~     This clinical study compares the efficacy, safety, and tolerability of therapy with ponesimod~     vs placebo in subjects with active RMS who are treated with DMF (Tecfidera®).~   "
50398|NCT02907164|"~     The investigators are interested in using social norms to motivate people to sign up for a~     100-day exercise challenge and exploring how to make social norms messages more effective.~   "
50399|NCT02907151|"~     To assess the value of a dedicated knowledge questionnaire, filled by the patient prior~     consultation. Indeed, it could allow to target specific shortcomings of patients first, and~     help the cardiologist to prioritize the other therapeutic education, targeting specifically~     the information provided.~   "
50400|NCT02907138|"~     The purpose of this study is to compare the effect of Medical Yoga as a group treatment, to~     conventional treatment provided by a physical therapist, for people with perceived~     stress-related symptoms.~      Forty people are to be randomized to either:~        1. Intervention Group - Medical Yoga, group treatment for eight weeks, 60 minutes per week,~          with the guidance of a physical therapist.~           or~        2. Control - treatment as usual (TAU) in physical therapy.~   "
50401|NCT02907125|"~     SEHER Plus- Strengthening Evidence base on scHool-based intErventions for pRomoting~     adolescent health, seeks to evaluate a school based adolescent health promotion intervention~     delivered by two different delivery agents viz. teacher-as-SEHER Mitra (TSM) and lay school~     counsellor called as SEHER Mitra (SM) in government- run secondary schools in Bihar, India.~     SEHER Plus will be implemented in the same randomly assigned 74 schools wherein, the SEHER~     trial (ClinicalTrials.gov ID: NCT02484014)-a three armed clustered randomised trial (CRT) was~     implemented to evaluate the effectiveness and cost-effectiveness of these two models compared~     with the Tarang-Adolescence Education Programme (usual care) implemented by the State~     Government of Bihar.~      The SEHER trial hypothesised that both interventions, compared to the control arm, would lead~     to a greater impact on school climate (school connectedness and relationship with teachers~     and fellow students). In addition, the interventions would increase the knowledge, attitude~     and awareness, and promoting healthy behaviours in youth on reproductive and sexual health~     outcomes, mental health and substance use, and gender related attitudes and violence. The~     SEHER trial also hypothesized that the addition of more resource intensive component (the SM~     arm) would be associated with the best outcomes. The hypothesis for the SEHER Plus is that~     students who will have exposure to the SEHER intervention activities in two academic years~     (Class IX and X) will show greater benefits on the primary, secondary and exploratory~     outcomes than students who have exposure to the SEHER intervention activities in one academic~     year (Class IX).~   "
50402|NCT02907112|"~     Excessive meat consumption, particularly of red and processed meat, is associated with~     increased risk of developing a range of chronic diseases. Meat production also significantly~     contributes to the production of global greenhouse gasses (GHG). Given the predicted global~     increase in the human population, coupled with the rise in demand for meat within emerging~     economies, it has been suggested that strategies to alter dietary patterns and reduce meat~     intake should be devised. With the provision of appropriate non- or reduced-meat~     alternatives, this study aims to investigate whether free living subjects can significantly~     reduce their meat intake, and whether such dietary changes positively impact on a range of~     health measures~   "
50403|NCT02907099|"~     The goal of this clinical research study is to learn about the effectiveness, safety, and~     tolerability of pembrolizumab in combination with BL-8040 when given to patients with~     advanced pancreatic cancer.~      This is an investigational study. Pembrolizumab is FDA approved and commercially available~     for the treatment of melanoma and lung cancer; however, it is not FDA approved for pancreatic~     cancer. BL-8040 is not FDA approved or commercially available for the treatment of pancreatic~     cancer.~      The study doctor can explain how the study drugs are designed to work.~      Up to 15 participants will take part in this study. All will be enrolled at MD Anderson.~   "
50404|NCT02907086|"~     Observational study to allow the collection of blood and medical information to evaluate the~     role of circulating tumor material in patients with colorectal cancer and melanoma~   "
50405|NCT02907073|"~     The goal of this proposal is to perform first-in-man evaluation of and experimental imaging~     agent F-18 tetrafluoroborate (BF4) or (TFB).~   "
50406|NCT02907060|"~     A pregnancy is considered ''prolonged'' from 41 weeks of gestation. Prolonged Pregnancies~     (PP) are associated with increased maternal morbidity: emergency caesarean, 3rd and 4th~     degree perineal lesions and postpartum haemorrhage. Foetuses are at increased risk of~     oligohydramnios, meconium-staining and Fetal Heart Rate (FHR) anomalies. Around 15% of all~     pregnancies are prolonged.~      A Cochrane review on induction of labour showed that a policy of labour induction at or~     beyond 41 weeks was associated with significantly fewer perinatal deaths. Thus the French~     College of Obstetricians and Gynaecologists stated, induction of labour can be proposed to~     patients between 41+0 and 41+6 weeks of gestation. In cases where labour is induced and~     cervix is unfavourable, cervical ripening is advised. Methods of cervical ripening include~     pharmacological (prostaglandins) and mechanical (Foley catheter or trans-cervical double~     balloon) methods. Those two methods were compared in the PROBAAT trial among women with term~     pregnancies (beyond 37+0). The rates of caesarean section with these two strategies were~     identical, however uterine hyper stimulation with FHR anomalies occurred less when cervical~     ripening was mechanical.~      Considering pharmacological cervical ripening is associated with more uterine hyper~     stimulation and more FHR anomalies, it may not be the most appropriate in cases of fragile~     foetuses that include cases of prolonged pregnancies. Considering prolonged pregnancies are~     associated with a risk of FHR anomalies and that cervical ripening with a pharmacological~     method is another factor which increases this risk: women with prolonged pregnancies could~     benefit from a more gentle cervical ripening.~      At present, no particular method is recommended in cases of cervical ripening and prolonged~     pregnancies. We hypothesise that, in cases of prolonged pregnancies, mechanical cervical~     ripening, with less uterine hyperstimulation and fewer FHR anomalies, could be more~     appropriate and could reduce the rate of caesarean section for suspicion of fetal distress.~   "
84203|NCT02464865|"~     This study is aimed to assess the prevalence of thiamin deficiency in obese Thai children.~   "
50409|NCT02907021|"~     Trastuzumab is an important treatment for HER 2 positive breast cancer. But trastuzumab can~     cause injury to the heart, and this is one of the main reasons it cannot be administered as~     planned. Heart injury can often be successfully treated using cardiac medications. The aim of~     SCHOLAR is to evaluate whether it is safe to continue trastuzumab in individuals with mild or~     moderate cardiac injury, while treating them with appropriate cardiac medications. In this~     way the investigators hope to be able to optimise the delivery of a treatment to patients~     with breast cancer that has proven survival benefits, especially when administered for a full~     12-month course.~   "
50410|NCT02907008|"~     The aim of the study is to evaluate the impact of sleep quality on intubation rate in~     intensive care units patients with acute respiratory failure~   "
50411|NCT02906995|"~     The purpose of the study is to compare two different dosage forms from which nicotine is~     released and absorbed into the bloodstream.~   "
50412|NCT02906982|"~     The purpose of this study is to evaluate the efficacy of a novel gum health formulation, when~     used in an intra-oral device or on a toothbrush, for teeth whitening and clinical~     improvements in periodontal diseases.~   "
50413|NCT02906969|"~     Background:~      The investigators assessed the use of a colonoscopy instructional video to improve both bowel~     preparation and education prior to procedure. Preceding studies have been vague, pinning~     patient education via diagrams and text as both pivotal and useless for compliance in bowel~     preparations. These studies however lacked assessment of comprehension prior to procedure.~      Methodology:~      This is a prospective study of diverse, inner city outpatient university center, first time~     colonoscopy patients given 1 of 2 on-site videos and written/verbal instruction.~     Experimentals saw a 5 min video on the purpose of colonoscopy, bowel preparation,~     pre-colonoscopy diet, and proper laxative use. Controls saw a 5 min video from the same~     spokesperson on upper endoscopy; which was trivial. Both groups were given a quiz within 30~     days of the colonoscopy on demographics, and 14 test questions about colonoscopy and~     preparation. Subsequently, endoscopists used the additive Ottawa scale to rate quality of~     preparation (range 0-14) via: fluid (0=sm,1=mod, 2=lg) and cleanliness in each the right, mid~     and rectosigmoid colon, (0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate).~   "
50414|NCT02906956|"~     The purpose of this study is to explore whether adherence to upper extremity home programs~     changes when persons post stroke practice with preferred music.~   "
50415|NCT02906943|"~     Substantial progress has been made in the treatment of cancer through the use of targeted~     therapies, but what works for one patient might not work for another patient. Certain drugs~     are now being developed that target specific molecules in the body that are believed to be~     part of the disease.~      Biomarkers are specific characteristics of the cancer that may help provide prognostic~     information (e.g. how well patients will be regardless of the treatments given) or help~     predict sensitivity or resistance to a specific treatment.~      The study will collect archival tumor samples (previously collected biopsy or surgical tumor~     samples) to provide biomarker data about a patient's cancer, which may help their physicians~     to identify which clinical trials of new drug treatments may be most appropriate for the~     patient in the future and may also guide the use of approved treatments that may potentially~     benefit the patient.~      Another goal of this study is to develop a province-wide registry of targeted gene sequencing~     testing results that will be made available to cancer researchers. Additional tumour tissue~     and blood samples collected from all study participants will also be stored in a biobank at~     the Ontario Institute for Cancer Research for future research.~      The study will also look at linking data from this study to other health care databases to~     further collect information about the health care the patients received, including medical~     tests, clinic visits, or procedures both before and after participating in this study. Having~     more information about patient health to relate to the DNA sequences may provide new insights~     into cancer and its treatment.~   "
50416|NCT02906930|"~     This trial is conducted globally. The aim of this trial is to investigate efficacy and safety~     of oral semaglutide versus placebo in subjects with type 2 diabetes mellitus treated with~     diet and exercise only.~   "
50417|NCT02906917|"~     Trial comparing effect and safety of insulin degludec/insulin aspart vs. insulin glargine~     plus insulin aspart in subjects with type 2 diabetes treated with basal insulin with or~     without oral antidiabetic treatment in need of treatment intensification.~   "
50418|NCT02906904|"~     Non Rapid Eye Movement (NREM) sleep parasomnias (sleepwalking and sleep terrors) are frequent~     and disabling sleep disorders characterized by arousal specifically from slow wave sleep~     (SWS) with dissociated brain activity that may be related to lower nociceptive state. The~     investigators recently reported frequent subjective complaints of chronic pain, migraine and~     headache during wakefulness in adult sleepwalkers. They also described frequent analgesia~     during severe and injuring episodes, suggesting a relationship between dissociated brain~     activity and nociceptive dysregulation. However, this study did not included objective~     nociceptive measures and the retrospective assessment of perceived pain during parasomnia~     episodes over a lifetime span might also introduce a recall bias.~      The aims of the present study are to measure objective pain sensitivity in patients with NREM~     parasomnias and matched controls during 1) parasomniac episodes, 2) light NREM sleep and SWS,~     and 3) wakefulness.~      Fifteen adults with severe NREM parasomnia and 15 age and sex-matched controls will be~     recruited. A 25 hours (8 AM to 9 AM) sleep deprivation protocol followed by auditory~     stimulations during SWS will be used to trigger parasomniac episodes. Thermoalgic~     stimulations of graduate intensity will be applied during wakefulness (8 PM) to determine the~     nociceptive threshold. During the recovery sleep following the sleep deprivation, the~     investigators will apply repeated subthreshold thermoalgic stimulations in NREM stage 2, SWS~     and triggered parasomniac episodes and report the behavioural/neurophysiologic nociceptive~     responses.~      The investigators hypothesized a lower nociceptive threshold during wakefulness in~     sleepwalkers and a decrease of the arousabiliy during SWS and parasomniac episodes. This~     study may help to better understand the etiology and mechanisms underlying the clinical~     enigma of the nociceptive dysregulation in NREM sleep parasomnias.~   "
50419|NCT02906891|"~     A single center pilot study assessing the Vigilant Diabetes Management Companion for the~     prevention of recurrent nocturnal hypoglycemia in type I diabetes patients.~   "
50420|NCT02906878|"~     PLATCAT study's purpose is to evaluate platelet kinetics after platelet transfusion~   "
50421|NCT02906865|"~     Proximal hamstring rupture is a rare injury, which may be immediately diagnosed.~      In 1996, Sallay showed that functional results of surgical repair were better than those of~     conservative treatment. Surgery is now the rule. The main aim of this study is to obtain a~     more detailed and quantified description of the postoperative outcomes.~   "
50422|NCT02906852|"~     The aim of this study is to evaluate the performance of Inivata liquid biopsy analysis~     compared with standard tissue biopsy analysis for detection of genomic alterations in~     patients with advanced lung cancer.~   "
52591|NCT02878564|"~     The aim of this study is to assess the impact of Schistosoma mansoni infection and its~     treatment on genital immunology and HIV susceptibility in Ugandan women.~   "
50424|NCT02906826|"~     An airway clearance technique (ACT) is one of the core treatments for children with chronic~     lung diseases who are unable to clear their secretions effectively. Unfortunately adherence~     to performing an ACT is low with a reported rate between 40 - 70%. Up to the present, there~     has been no way to objectively measure adherence to an ACT. With new technology, it is now~     feasible to connect an electronic manometer to an airway clearance device to objectively~     measure how often the child is actually performing their ACT. The first part of this proposed~     study is to objectively measure adherence against reported adherence over a 4 month period.~     During the second 4 months a video game will be added to the digital manometer which only~     operates if participants are performing their ACT properly. Adherence will again be measured.~   "
50425|NCT02906813|"~     The purpose of this study is to assess the relative bioavailability (BA) of 300 milligram~     (mg) TAK-935 tablets compared to 300 mg of TAK-935 solution and to determine the effect of~     food on the BA of TAK-935 300 mg tablets in healthy adult participants.~   "
50426|NCT02906800|"~     Introduction: Patients with primary unresectable advanced head and neck squamous cell~     carcinomas (HNSCC) have a poor prognosis with a median survival of 22 months (Hauswald H~     Radiat Oncol 2011). They are usually treated with induction chemotherapy followed by~     radiochemotherapy or platinum-based concomitant radiochemotherapy. Most patients achieve an~     objective clinical response contrasting with a high rate of local recurrence and distant~     metastases in the year following radiochemotherapy (Argiris A Ann Oncol 2011). Improvement of~     the efficacy of chemotherapy remains therefore a major clinical goal for this group of~     patients. During the past years, the investigators demonstrated that some conventional~     chemotherapeutics (anthracycline, oxaliplatin…) induce a type of immunogenic cell death~     (ICD) characterized by the exposure of calreticulin on the tumor cell surface, the secretion~     of ATP and the release of high-mobility group box 1 (HMGB1) resulting in activation of tumor~     immunity (Galluzzi L Nat Rev Drug Discov 2012). The investigators recently showed that the~     Na/K-ATPase inhibitor, digoxin, favors ICD, when combined with cisplatin, a drug known not to~     induce ICD. In preclinical models, a synergy between cisplatin and digoxin which led to a~     significant therapeutic improvement (Menger L Sci Transl Med 2012) has been observed. This~     effect seems to be mediated by the immune system as the combined therapy induced intratumor T~     cell infiltration producing cytokines (Menger L Sci Transl Med 2012).~      Hypothesis: Based on our preclinical data, the hypothesis is that adding digoxin to the~     conventional cisplatin based induction chemotherapy regimen in unresectable advanced HNSCC~     will increase the efficacy of this therapy via the induction of anti-tumor immunity.~      Objectives:~      Main: the primary objective is to assess the clinical and biological safety of the~     combination of digoxin to cisplatin-based chemotherapy.~      Secondary: The secondary objectives are to investigate biological markers of efficacy by~     analyzing the recruitment of functional T cells in tumour biopsies after treatment with the~     combination of digoxin and chemotherapy.~   "
50427|NCT02906787|"~     The purpose of this research study is to better understand (1) why people gain weight when~     they quit smoking and (2) whether certain types of smoking cessation (i.e. quit smoking)~     counseling combined with the nicotine patch help people quit smoking and gain less weight.~   "
50428|NCT02906774|"~     This is a proof-of-principle research study designed to determine whether fecal microbiota~     transplantation (FMT) can eliminate highly drug-resistant bacteria from the intestinal tract~     of renal transplant patients. The primary goal of this study is to test whether oral gut~     decontamination followed by FMT by enema delivery will result in decolonization of the~     intestinal tract of renal transplant patients shortly after solid organ transplantation,~     thereby preventing difficult to treat post-transplant infections.~   "
50429|NCT02906761|"~     Asthma is characterized by changes in eicosanoids metabolism, especially high production of~     bronchoconstrictive cysteinyl leukotrienes (CystLTBs) and leukotriene B4 (LTB4). Recent~     studies have also demonstrated a relative low production of lipoxin A4, an endogenous lipid~     mediator resulting from lipo-oxygenase action, distinct from CystLTBs, with anti-inflammatory~     properties, in bronchial epithelial cells and lung macrophages of severe asthma patients,~     leading to imbalance between pro-resolving and pro-inflammatory eicosanoids production in~     airways. Such data suggest that aspirin, that induces lipoxins production, could restore~     lipoxins deficit in severe asthma. Interest for aspirin is also supported by data obtained in~     asthma patients with aspirin intolerance (Aspirin induced asthma, AIA) : in this particular~     group of patients, aspirin treatment significantly improves nasal symptoms, quality of life,~     asthma and rhinitis scores, and reduces need for hospitalizations, nasal surgery and oral~     steroids use. Potential effect of aspirin in patients with uncontrolled asthma without~     aspirin intolerance, who presented changes in arachidonic acid pathway close to those~     observed in AIA, is not established.~      The aim of the study is to assess whether long term aspirin treatment could improve asthma~     control, compared to placebo, in patients with uncontrolled disease and nasal polyposis,~     whatever their aspirin tolerance level.~   "
50430|NCT02906748|"~     The functional parathyroid auto-transplantation (PA) could release parathyroid hormone (PTH)~     into the circulatory system of the body through the capillaries. But when parathyroid glands~     were auto-grafted in the sternocleidomastoid muscle, it would be inconvenient to detect PTH~     to examine whether the graft functions. So the investigators took the forearm as the aim~     place for auto-transplantation, either subcutaneous or brachioradialis, with its relatively~     fixed - antecubital vein blood test which is simple. The survival criteria is assumed as the~     PTH gradient of 1.5 times or greater through comparing the bilateral PTH value in grafted and~     not-grafted forearm.~   "
50431|NCT02906735|"~     Knee reconstructive surgery (knee prosthesis, osteotomies) often results in changes of~     alignment of the lower limb axis. This affects also biomechanics of the hindfoot. There is a~     lack of understanding what changes of alignment of the lower limb causes to the ankle. The~     investigators want to evaluate the effects of knee surgeries onto the plantar foot pressure~     investigated by means of static and dynamic pedography.~   "
50432|NCT02906722|"~     Few antimicrobials are available to treat ventilated associated pneumonia (VAP) caused by~     Gram negative multi-resistant (MDR) bacteria. Colimycin often remains the only active~     antibiotic. The aim of the study is to demonstrate the superiority of nebulized colimycin~     over intravenous colimycin to treat VAP caused by Gramnegative MDR bacteria.~   "
50433|NCT02906709|"~     This study will examine the efficacy of omarigliptin 25 mg once weekly compared to placebo in~     Japanese patients with T2DM who have inadequate glycemic control on insulin monotherapy in~     addition to diet and exercise therapy. The primary hypothesis of the study is that~     omarigliptin 25 mg once weekly provides greater reduction in hemoglobin A1C (HbA1c) compared~     with placebo as assessed by change from baseline to Week 16 [Phase A (double-blind period)].~   "
50460|NCT02906358|"~     The purpose of this study is to conduct a parallel group, randomized trial of primary care~     clinic-based and community-based programs to educate and support low-income, Hispanic~     patients with chronic pain to adopt evidence-based pain self-care behaviors and activities.~   "
50434|NCT02906696|"~     Bosutinib is a type of tyrosine kinase inhibitor (TKI) which is commonly used for the~     treatment of chronic phase chronic myelogenous leukemia (CP CML). The standard dose of~     bosutinib often causes temporary, but severe, diarrhea which goes away after bosutinib is~     stopped or the dose is lowered.~      The goal of this clinical research study it to learn if a lower dose of bosutinib is as~     effective as the standard dose. Researchers think that by starting with a lower dose of~     bosutinib and slowly increasing the dose (if needed), the likelihood and severity of diarrhea~     and other side effects may be lowered in patients with CP CML.~      To help researchers learn if the lower dose of bosutinib is as effective as the regular dose,~     researchers will test your cytogenetic response to the drug. Cytogenetic testing looks at how~     genetic changes to cells (in this study, the BRC-ABL protein and Philadelphia chromosome) may~     affect how the disease may react to the study drug.~      This is an investigational study. This is an investigational study. Bosutinib is FDA approved~     and commercially available for the treatment of chronic phase CML. It is considered~     investigational to use bosutinib at a lower dose compared to the standard dose.~      The study doctor can explain how the study drug is designed to work.~      Up to 42 participants will take part in this study. All will be enrolled at MD Anderson.~   "
50435|NCT02906683|"~     The purpose of this study is to evaluate the efficacy and safety of TAS-303 in female~     patients with stress urinary incontinence.~   "
50436|NCT02906670|"~     This is the first study to test Sym013 (Pan-HER) in humans. The primary purpose of this study~     is to see if Sym013 is safe and effective for patients with advanced epithelial malignancies~     without available therapeutic options.~   "
50437|NCT02906657|"~     Context Adverse drug events (ADEs) may occur in hospitalized patients and may result from~     discrepancies between patient's current medications and the drugs prescribed at admission~     (omission, commission, dosing errors….). Consequences of these discrepancies may be mild~     (e.g. isolated biological abnormalities), but may also lead to severe clinical outcomes.~     Medication reconciliation is a process of creating the most accurate list of patient's~     current medication in order to decrease discrepancies and eventually ADEs. Information~     technology and electronic health records are of great interest in this process. In France,~     medications dispensed in community pharmacies during the past 4 months are registered in~     patient's electronic pharmaceutical record. The impact of this record together with a~     pharmacist medication reconciliation will be tested in the CONCIPAGE study.~      Design The CONCIPAGE study is a national, multicenter, cluster-randomized, two-period~     cross-over study. It will estimate the impact of a medication reconciliation, made by a~     pharmacist, using patient pharmaceutical record, on the occurrence of ADEs during the~     hospitalization of patients aged 65 years and over.~      Fifteen hospitals gathering 20 centers (8 geriatric departments, 8 internal medicine~     departments, and 4 orthopedic surgery departments) will participate in the study. An~     equilibrated randomization will be applied to the 20 centers. The recruiting period will last~     for 24 months and will be divided into four 6-month consecutive periods (A, B, C, D). During~     the first 6-month period (period A), 5 centers (1 to 5) will apply one strategy (intervention~     or usual care) while 5 others (6 to 10) will apply the alternative strategy. Centers 11 to 20~     will not recruit patients during period A. During the next period (period B), centers 11 to~     15 and 16 to 20 will apply the intervention or the control strategy, while centers 1 to 10~     will apply a 6-month wash-out period. During period C, centers 1 to 10 will apply the~     alternative strategy as compared to that applied during period A (cross-over design), while~     centers 11 to 20 will apply the 6-month wash-out period. During period D, centers 11 to 20~     will apply the alternative strategy as compared to that applied during period B, while~     centers 1 to 10 will not recruit patients during period D.~      Description of the intervention During the control period, no intervention will be held. The~     prior to admission medication list will be made as usual by the hospital physician: interview~     of the patient and relatives, prescriptions brought by the patient, call to community~     physicians and pharmacists, hospital medical records, etc. This process will result in a~     medication prescription list at admission.~      During the intervention period, a local hospital pharmacist will independently perform an~     additional (i.e. to that made by the hospital physician) prior to admission medication list,~     using the above-mentioned sources and in addition, with the help of the electronic~     pharmaceutical record. The medical reconciliation in the intervention period consists in the~     comparison of the pharmacist's and physician's prior to admission medication lists. Such a~     reconciliation might lead to a modification of the medication prescription that was made by~     the physician at admission.~      Patient follow-up Patients will be included the day of admission and will be followed-up up~     to 30 days. A study pharmacist will be enrolled and will be in charge of collecting follow-up~     data for all patients. The study pharmacist will visit centers 2, 4, and 7 months after the~     beginning of each period. He/she will study the record of each patient included in the study,~     and will collect all potential biological or clinical abnormalities, prescriptions of~     antidotes and diagnostic imaging, transfer to ICU, death.~      Objectives The primary objective of the study is to assess the impact of medication~     reconciliation by a pharmacist using usual sources plus the electronic pharmaceutical record~     on ADEs occurring in hospital settings.~      The secondary objectives are the following:~        -  To assess severity and preventability of ADEs in both groups.~        -  To assess the distribution of ADEs in both groups.~        -  To compare the 30-day mortality rates observed in the two groups.~        -  In the intervention group only, to assess the rate of intentional (treatment~          modification intended by the physician) and unintentional discrepancies between the~          prior to admission medication list made by the pharmacist and the hospital physician's~          prescription at admission.~        -  In the intervention group only, to assess the rate of discrepancies between the hospital~          prescription at admission and the prescription after medical reconciliation.~        -  To estimate the cost-effectiveness of the intervention.~   "
50438|NCT02906644|"~     This study plans to compare the efficacy of the nicotine patch / lorcaserin combination~     treatment vs. the nicotine patch alone in terms of leading to a reduction in smoking behavior~     and withdrawal symptoms.~   "
50439|NCT02906631|"~     Introduction: Acute encephalitis (AE) is a severe neurological disorder associated with~     significant morbidity and mortality. Approximately 50% of patients with AE require ICU~     admission because of coma, seizures or acute respiratory failure. Determinants of~     neurological prognosis in these patients are not known.~      Objectives:~      Main objective: To identify determinants of outcome in adult patients admitted to the ICU;~     Secondary objectives: a) To study the impact of diagnostic studies (Brain MRI, CSF analysis,~     EEG) on neurologic outcome; b) to describe the epidemiology of patients admitted to the ICU~     with AE; c) to study the impact of early appropriate therapy on neurologic outcomes; d) to~     describe morbidity and mortality associated with AE at 90 days and 1 year following~     diagnosis.~      Methods: prospective observational multicenter study in French ICUs. All patients admitted to~     the ICU for probable or confirmed AE (2013 IDSA criteria)with a Glasgow coma scale score < or~     =to 13 will be eligible for inclusion. Factors associated with a poor prognosis at 90 days~     will be identified by multivariable logistic regression analysis.~      Duration of study: 30 months (recruitment 18 months, follow-up 12 months).~      Patients: 300 patients~      Endpoints:~        -  Primary endpoint: The primary endpoint is the modified Rankin scale score 90 days~          following onset of abnormal status (GCS < or =13). This score will be determined by~          contacting the patient. A poor outcome will be defined as a mRS >2 at 90 days.~        -  Secondary endpoints: a) neurological findings within 7 days following onset of altered~          mental status; b) abnormal findings on diagnostic studies (MRI, EEG, CSF analysis)~          within7 days following onset of altered mental status; c) Time between onset of altered~          mental status and completion of diagnostic studies; d)Time between onset of altered~          mental status and start of appropriate specific therapy; e) neurologic outcomes at 1~          year mRS score and extended Glasgow outcome scale (GOS); f) causes of death in~          non-survivors at 1 year; g) quality of life and posttraumatic stress at 1 year: IADL and~          SF36 scales;~   "
50440|NCT02906618|"~     The study involves one dose of LY3039478 given by mouth followed by an intravenous infusion~     (IV) (via a tube linked to a small needle in the vein) of LY3039478. The results of this~     study will help to answer the following research questions:~        -  How much LY3039478 gets into the blood stream when given by mouth as a capsule compared~          to when given by an IV~        -  How long it takes the body to remove the study drug~        -  The safety of LY3039478 and any side effects that might be associated with it~      Participation in the study is expected to last up to 7 weeks. There will be screening, a~     single study period, and a follow-up.~   "
50441|NCT02906605|"~     The purpose of this study is to evaluate if the anti-tumor activity of JNJ-809 combined with~     apalutamide is improved compared with apalutamide alone for subjects with metastatic~     castration-resistant prostate cancer (mCRPC).~   "
50442|NCT02906592|"~     The objective of this study is to implement a brief geriatric oncology assessment (GOA) in a~     community-based oncology clinic, the Scotland Cancer Treatment Center - a clinic within the~     Duke Cancer Network, located in the rural, low resource Scotland County community of North~     Carolina. Secondly, the investigators will evaluate the effectiveness of the brief GOA by~     comparing historical and post-GOA service referral patterns and adherence to planned cancer~     therapy. For this study, the investigators will prospectively enroll up to 60 patients who~     have been diagnosed and/or treated for cancer to complete the brief GOA. In addition to these~     60 patients, the investigators will also conduct retrospective chart reviews on 120 patients~     that would be eligible for this study to evaluate past referral patterns. Eligible and~     consented patients will complete the brief GOA at the Scotland Cancer Treatment Center~     alongside their normal clinic appointment. The investigators will assess impact on the~     healthcare system by evaluating referral patterns (i.e., how many, what type of services)~     using the brief GOA data and EHR data. The study value includes the possibility for~     recognition and access to additional health care referrals if needed.~   "
50443|NCT02906579|"~     To evaluate the impact of escalating doses of IW-1973 on endothelial function [using EndoPAT~     to measure fingertip small vessel pulse volume], blood pressure (BP), and heart rate.~   "
50444|NCT02906566|"~     There has been increasing evidence for different rates of natural aging in humans and one of~     the best organs to study human aging is skin. Studies have demonstrated anti-aging effects of~     topical agents (such as creams, gels, lotions, or ointments) and one of them, retinol or~     vitamin A, was shown to decrease fine wrinkling in skin of older individuals. Additionally,~     studies of retinol in humans have largely occurred in white populations and so this study~     aims to focus on skin aging in individuals of East Asian descent as they represent a majority~     of the world population. This study aims to better characterize the molecular basis of~     rejuvenation effects and to potentially discover new topical agents with similar and/or more~     effective preservation of skin youthfulness.~   "
50445|NCT02906553|"~     This study evaluates the role of the Nitric Oxide system in cognition in patients with~     schizophrenia. Participants will be randomised to 2 equal groups and receive either the~     Nitric Oxide donor molecule glyceryl trinitrate, or a placebo. Performance on several~     cognitive tasks will be assessed.~   "
50446|NCT02906540|"~     To verify the efficacy of transpubic symphysis reset therapy for low back pain, and provide~     support for the clinical application of this treatment.~   "
55731|NCT02837523|"~     Development of a new MS-based biomarker for the early and sensitive diagnosis of Cystinosis~     disease from plasma.~   "
50447|NCT02906527|"~     The aim of the study is to compare, in real life, the risk benefit (including both major~     bleeding and thrombotic events (TE) and death from any cause) associated with direct oral~     anticoagulants (DOAC) and with anti vitamin K (VKA) in older adults (≥ 75 years) suffering~     from nvAF.~      The study will be conducted in the French Health insurance database (SNIIRAM). Data of octo+~     patients newly treated with an oral anticoagulant (VKA or DOAC) for non valvular atrial~     fibrillation (nv AF) will be collected from the first exposure of the patient to the drug of~     interest during the inclusion period to the end of the follow-up period (at least one year of~     follow-up for each patient).~   "
50448|NCT02906514|"~     Best priming for cardiopulmonary bypass in cardiac surgery is unknown. Efficacy and toxicity~     of Hydroxyethyl Starch 130/0.4 used in this context are uncertain.~      The aim of this pilot study is to determine if Hydroxyethyl Starch 130/0.4 is more effective~     than Sodium Chloride 0.9% in short term hemodynamic purpose without side renal or hemostatic~     effect.~   "
50449|NCT02906501|"~     Introduction: The use of low dose risperidone and other antipsychotic drugs off-label as~     augmentation treatment for adolescents with Attention Deficit Hyperactivity Disorder (ADHD)~     and Disruptive Behavioral Disorder (DBD) has become widely common worldwide, usually to help~     control behavioral difficulties. While some argue that agents that block dopaminergic~     receptors may have a deleterious cognitive effect, others stress their moderating effects,~     which possibly improve function in all domains, including cognitive functions. Only a few~     studies have examined this topic, with inconclusive results.~      Aim of study: To measure the effect of risperidone treatment on various cognitive functions~     in a population of ADHD diagnosed children and adolescents with normal IQ.~      Design: The study is an observational prospective open label clinical controlled trial. The~     investigators will compare the performance in a battery of cognitive tasks using the Penn~     Web-Based Computerized Neurocognitive Battery (WebCNP) and the IGT, in children and~     adolescents diagnosed with ADHD, with and without risperidone.~      Study population: Children and adolescents diagnosed with ADHD, 8-17 years old, may be~     eligible for this study. We will recruit subjects who their psychiatrist is considering~     rispieridone treatment, those who are already treated with risperidone and subjects with only~     stimulants treatment. All pharmacological treatment is supervised and prescribed to subjects~     by their personal psychiatrist unrelated to the study.~      Significance: Better knowledge of the specific cognitive effects of this form of therapy will~     help us guide both clinical decisions, and recommended monitoring in daily clinical work.~   "
50450|NCT02906488|"~     The purpose of this study is to assess the safety and efficacy of long-term use of Duodopa in~     patients with Parkinson's disease in actual usage~   "
50451|NCT02906475|"~     The primary objective of this study is to investigate the effectiveness of a standardized~     skin care regimen using a milk lotion once daily and a bathing addendum as needed during the~     first 52 weeks of life on the development of atopic Dermatitis (AD) compared to no structured~     skin care regimen in infants with atopic predisposition. Secondary objectives are to~     investigate the influence of a structured skin care regimen on the development of AD in the~     second year of life and the skin barrier function up to the infants' age of 2 years.~   "
50452|NCT02906462|"~     In 2003, MAHO study (Ferrand E, Jabre P, Vincent-Genod C, et al. Circumstances of death in~     hospitalized patients and nurses' perceptions: French multicenter Mort-a-l'Hôpital survey.~     Arch Intern Med. 2008 168: 867-875.) evaluated the way 3793 patients died in 200 French~     hospitals and showed that their conditions of death were not optimal. The 22th April 2005~     French Law precised patient's end of life rights with necessity to refrain from any~     unreasonable obstinacy, the right to refuse treatments and the obligation of a collegial~     process decision when the patient is not conscious. Since then, studies haven't demonstrate~     any improvement and found that palliative strategy in France is much less used than in other~     developed countries.~   "
50453|NCT02906449|"~     The primary purpose of this study is to investigate the effectiveness of a brief~     mindfulness-based intervention for targeting chronic physiological underarousal and~     post-concussive symptoms following a mild head injury (MHI), as self-reported by~     undergraduate university students. For the purposes of this study, MHI is defined (and~     identified) through our demographic questionnaire as a traumatic-based injury to the head -~     Have you ever hit your head with a force sufficient to alter your state of consciousness~     (consistent with the Kay et al., 1993 criteria/definition; American Congress of~     Rehabilitation Medicine - ACRM). The investigators exclude congenital or genetic injuries.~   "
50454|NCT02906436|"~     Only about 15% of the potential candidates for lung donation are considered suitable for~     transplantation. Thus, a strategy that could improve the quality and precision of assessment~     of nonacceptable donor lungs could have a major impact on reducing waiting time and mortality~     while on the list.~      A new method for ex vivo lung perfusion (EVLP) has been developed recently by Steen and~     colleagues to assess the quality of lungs from a non-heart-beating donor. The method can also~     be used to recondition marginal and nonacceptable donor lungs.~      After harvesting, the lungs were perfused ex vivo with Steen Solution, an extracellular~     matrix with high colloid osmotic pressure. A membrane oxygenator connected to the circuit~     received gas from a mixture of nitrogen and carbon dioxide, maintaining a normal mixed venous~     blood gas level in the perfusate. The lungs were gradually rewarmed, reperfused, and~     ventilated for evaluation through analyses of oxygenation capacity, pulmonary vascular~     resistance (PVR), lung compliance (LC), and biopsy.~   "
50455|NCT02906423|"~     The purpose of this retrospective chart review pilot study is to research the results and~     scores of the QOL questionnaire implemented across Allina Health clinics. This study will~     investigate average QOL scores by clinical population and demographic group, the change in~     scores over time, and the effect of clinical interventions on QOL scores. The results will~     provide insight into QOL trends within different patient populations and provide guidance~     regarding optimal treatment plans so that Allina caregivers can positively impact patients'~     QOL.~   "
50456|NCT02906410|"~     Participants will be asked to select a hypothetical lunch from a menu that features entrees,~     sides, and drinks. Participants will be able to select a maximum of 1 item from each~     category. Following this meal selection, participants will complete a short survey about~     their demographics, their estimates of information about the meal and about recommended~     eating habits.~   "
50457|NCT02906397|"~     To determine the safety and tolerability of galunisertib when combined with Stereotactic Body~     Radiotherapy (SBRT) (hypofractionated radiation).~   "
50462|NCT02906332|"~     This is an open-label, Phase II, single center trial of pembrolizumab (MK-3475), lenalidomide~     and dexamethasone in subjects with high risk Multiple Myeloma (hrMM) post high-dose~     chemotherapy with autologous stem cell transplantation (ASCT).~      Patients with high-risk MM defined as those with one of the following abnormalities who have~     undergone induction therapy followed by single or tandem melphalan -based ASCT will be~     considered eligible.~   "
50463|NCT02906319|"~     The purpose of this study is to determine the association between serum 25-hydroxyvitamin D~     and HbA1c levels in diabetic patients with chronic kidney disease. The investigators~     hypothesized that serum 25-hydroxyvitamin D levels were negatively correlated with HbA1c~     levels.~   "
50464|NCT02906306|"~     The objective of this study is to determine whether individual and/or group occupational~     therapy leads to changes in generalized self-efficacy and psychological well-being, and to~     identify the type of therapy that has the best effects on older adults.~   "
50465|NCT02906293|"~     This study seeks to: Assess normal intestinal event rates for healthy subjects, to~     determine the effect of meal size on an individual's intestinal rate, and to determine~     whether there are differences between individuals in the fasting and post-prandial setting.~      The investigators hypothesize the following:~        1. Fasting intestinal rate will be consistently less than 14 events per minute, similar to~          previously documented bowel sound frequency.~        2. There will a uniform increase in intestinal rate in the immediate post-prandial setting.~          There will be direct correlation between maximal and average post-prandial intestinal~          rates and meal size. Likewise, meal size will correlate with time to baseline fasting~          intestinal rate.~        3. Males and those with lower body mass index (BMI) will experience higher maximal and~          average post-prandial intestinal rates and shorter time to baseline fasting levels~          compared to females and those with higher BMI, respectively.~   "
50466|NCT02906280|"~     EBUS-TBNA is often the sole diagnostic test applied in patients with stage IV lung cancer. A~     limitation of the TBNA needle when using a 22 Gauge needle is the limited ability to procure~     adequate histological samples. Although a larger 19 Ga needle can procure histological~     samples as demonstrated by the conventional 19 Ga needle, published data are not existing~     with respect to molecular diagnostics. A new nitinol-based 19 Ga needle has been developed~     for EBUS-TBNA. Given the frequent usage of 22 Ga needles for molecular diagnostics and the~     recent technical advancements in 19 Ga needle technology, we conduct a RCT to compare the~     performance of both needle types.~   "
50467|NCT02906267|"~     This study is designed to evaluate the occurrence of gastric insufflation and the critical~     volume of the stomach after three different modes of positive pressure ventilation during~     induction (Manual-controlled, volume-controlled and pressure-controlled ventilation)~   "
50468|NCT02906254|"~     Febrile neutropenia requires prompt initiation of broad-spectrum antibiotics, which can be~     responsible for side-effects and selection of resistance. This study demonstrates the safety~     of an early discontinuation of empirical treatments, in carefully selected patients~     presenting with fever of unknown origin.~   "
50469|NCT02906241|"~     This research has the overall goal of increasing rates at which African American and White~     men with prostate cancer make an informed decision to participate in a cancer clinical trial.~   "
50470|NCT02906228|"~     The purpose of this study is to investigate possible effects of radio frequency~     electromagnetic fields on EEG activity during sleep and on Brain function during wake (EEG in~     the resting state condition, slow EEG potentials, auditory evoked potentials) and cognitive~     performance measures in test of selective attention, divided attention and working memory in~     healthy elderly females (60 - 80 years).~   "
50471|NCT02906215|"~     Many people living with HIV use illicit drugs and require treatment for both HIV and drug~     use, however, many barriers exist which prevent integration of dual care services. This study~     will develop a novel intervention aimed at the provider-level which will combine an~     evidence-based training model with use of mobile technology to improve care coordination~     between providers at HIV clinics and substance use treatment facilities. If proven effective,~     this intervention may be widely disseminated and easily implemented into existing clinic~     structures, thereby improving care coordination among providers and linkage to dual treatment~     for HIV-infected people who use drugs.~   "
50472|NCT02906202|"~     This is a single-arm, multi-site, single-dose, Phase 3 study in approximately 23 subjects ≤50~     years of age with transfusion-dependent β-thalassemia (TDT), also known as β-thalassemia~     major, who do not have a β0 mutation at both alleles of the hemoglobin β (HBB) gene. The~     study will evaluate the efficacy and safety of autologous hematopoietic stem cell~     transplantation (HSCT) using LentiGlobin BB305 Drug Product.~   "
50473|NCT02906189|"~     The primary objective of the study is to determine the safety of MRI in patients with non-MRI~     conditional pacemakers. The secondary objective is to determine if there are clinically~     relevant parameter changes in the devices.~   "
50474|NCT02906176|"~     A clinical trail to investigate the influence of SLCO2B1 polymorphism on the pharmacokinetic~     characteristics of voriconazole in CYP2C19 poor metabolizers~   "
50475|NCT02906163|"~     Phase I: evaluate the safety and tolerability two different dosing regimens of Thymosin alpha~     1 in patients with advanced EGFR mutation positive NSCLC on Standard of Care (SoC) therapy.~      Phase II: evaluate the efficacy in terms of PFS of Thymosin alpha 1 in patients with advanced~     EGFR mutant NSCLC taking SoC as compared to SoC alone.~   "
50476|NCT02906150|"~     Thymosin alpha 1 plus maintenance therapy with the Standard of Care (SoC) chemotherapy plus~     cisplatin (or carboplatin) in patients with metastatic Non-Small Cell Lung Cancer (NSCLC),~     EGFR wild type~   "
50477|NCT02906137|"~     The gut immune barrier is not fully restored in HIV-1-infected subjects despite they were~     receiving antiretroviral treatment. This leaky gut leads to microbial translocation from the~     gut lumen into the bloodstream that fuels deleterious systemic inflammation. The chemotaxis~     axes that allow T lymphocytes to migrate from the blood to the gut mucosa in order to~     reconstitute the mucosal immune barrier seems altered in treated HIV-1-infected subjects.This~     study aims at better understanding the mechanisms involved in this lack of mucosal immune~     restoration.~   "
50478|NCT02906124|"~     To evaluate outcomes of pregnancy in females diagnosed with familial hypercholesterolaemia~     (FH), exposed to Repatha® during pregnancy. This includes follow-up of their infants to the~     age of 12 months~   "
50480|NCT02906098|"~     This study evaluates behavioral interventions to increase adolescent's motivation for self~     performed periodontal infection control, by means of adequate oral hygiene. Study subjects~     will be allocated to test and control group where the test will be subjected to an~     individually tailored oral health education program, based on cognitive- behavioral theory~     and principles, and the control to standard educational intervention.~   "
50481|NCT02906085|"~     One third of migraine patients experience aura, i.e. dramatic, transient neurological~     symptoms, most often in the form of visual disturbances, that usually appear before the onset~     of migraine headache. The likely underlying mechanism of aura is known as cortical spreading~     depression, a wave of changes in electrical activity that slowly spreads in the outermost~     layer of the brain. It is currently not known what causes the aura to initiate in patients or~     what the relationship is between aura and migraine headache, e.g. if treatment targeted at~     aura mechanisms will prevent subsequent headache. Due to the short-lasting and unpredictable~     nature of aura, the only possible approach for systematic investigations is to experimentally~     trigger aura, but currently no method for aura-triggering is available.~      The overall goal of the proposed project is to reveal the earliest mechanisms of the migraine~     attack by investigating the initiating factors of aura in the migraine brain.~      Current animal evidence indicates that infusion of endothelin-1 (ET-1), a naturally occurring~     signaling molecule released from blood vessels, is safe and very likely to trigger migraine~     aura in patients.~      In this project the investigators aim to study the effects of ET-1 on the human brain, to~     investigate aura-inducing effects of ET-1 in patients and to develop a safe and reliable~     method for the experimental induction of migraine aura using ET-1.~   "
50482|NCT02906072|"~     The effect of a diet free from animal-sourced nutrients on body composition in weight~     reduction programs is not well established. In this non-randomised free living interventional~     case-control study, the investigators will document the effects of a 10-week, low-fat,~     plant-based diet supplemented with two daily plant-based meal replacements on body~     composition indices measured with bioimpedance analysis. Control subjects will be exposed to~     weekly lectures on the rationale and expected benefits of plant-based nutrition. The~     investigators hypothesise that low-fat plant based diet supplemented with meal replacements~     eaten ad libitum allows a significant reduction of body fat without the loss of lean tissue.~   "
50483|NCT02906059|"~     The purpose of this study is to determine whether combination therapy of irinotecan with~     AZD1775 is safe and effective in treating mutated metastatic colorectal cancer patients.~   "
50484|NCT02906046|"~     Few studies evaluated the efficacy of adding weights on the lower limbs in patients with~     ataxic disorders. There is no current evidence on which would be the most appropriate weight~     for use in this context. To assess progress and benefits of using this load, gait of~     symptomatic carriers of spinocerebellar ataxia type 3/Machado Joseph disease the objective of~     the study is to evaluate the gait with and without different load weights on lower limbs.~     Outcomes were the Scale for the Assessment and Ataxia Rating of (SARA), kinematic gait~     assessment by the accelerometer and gyroscope and the Patient Global Impression (PGI) about~     which weight they prefer for walking.~   "
50485|NCT02906033|"~     The aim of the study is to improve the surgical patients' care process. The objective is to~     explore the effect of a new perioperative practice model on 1) patient outcomes~     (satisfaction, surgery-related anxiety and quality of life), 2) nursing outcomes~     (organizational engagement), and 3) organization outcomes (timeline of surgical care~     process).~   "
50486|NCT02906020|"~     Primary Objectives:~        -  Part 1: To determine the safety and tolerability of GZ/SAR402671 administered orally, as~          compared to placebo in patients with early-stage Parkinson's disease (PD) carrying a GBA~          mutation or other pre-specified variants.~        -  Part 2: To determine the efficacy of GZ/SAR402671 administered orally daily, as compared~          to placebo in patients with early-stage Parkinson's disease carrying a GBA mutation or~          other pre-specified variants.~      Secondary Objectives:~      Part 1:~        -  To assess the pharmacokinetic (PK) profile of oral dosing of GZ/SAR4027671 in plasma~          when administered in early-stage Parkinson's disease patients carrying a GBA mutation.~        -  To assess the exposure of GZ/SAR402671 in cerebrospinal fluid (CSF) when administered in~          early-stage Parkinson's disease patients carrying a GBA mutation.~      Part 2:~        -  To demonstrate overall safety and tolerability of GZ/SAR4027671 administered orally in~          early-stage Parkinson's disease patients carrying a GBA mutation as compared to placebo.~        -  To assess the pharmacodynamic response to daily oral dosing of GZ/SAR402671 in plasma~          and CSF as measured by glucosylceramide (GL-1) when administered in early-stage~          Parkinson's disease patients carrying a GBA mutation.~   "
50487|NCT02906007|"~     The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability~     of an antituberculosis drug, bedaquiline (BDQ), when used to treat multidrug-resistant~     tuberculosis (MDR-TB) in HIV-infected and HIV-uninfected infants, children, and adolescents.~   "
50488|NCT02905994|"~     The study intervention involved in this study is the addition of a dose of volasertib as a~     part of the initial chemotherapy regimen for AML.~      The trial will involve a combination of the following drugs:~        -  Volasertib (the study drug)~        -  Idarubicin~        -  Cytarabine~   "
50489|NCT02905981|"~     The main purpose is to determine whether Triferic, administered orally with Shohl's solution,~     is safe and effective for the treatment of iron-refractory iron-deficiency anemia (IRIDA).~   "
50490|NCT02905968|"~     The purpose of this study is to evaluate the effectiveness of transanual tube placement in~     low anterior resection (LAR) for rectal cancer in preventing anastomotic leakage.~   "
50491|NCT02905955|"~     All patients with deep venous obstruction below the sapheno-femoral junction elective for~     hybrid procedure with creation of an arterio venous-fistula (AVF) in the MUMC or patients~     with primary percutaneous procedure (and thus venous obstruction above the sapheno-femoral~     junction) who present with occluded stents which need an additional AVF after thrombolysis~     will receive a Prevena NPWT. Incidence of wound infections and wound scoring will be~     performed afterwards.~   "
50492|NCT02905942|"~     The purpose of the study is to evaluate the efficacy and safety of PEG-rhG-CSF on the~     recovery of hematopoietic function after autologous stem cell transplantation in patients~     with lymphoma.~   "
51452|NCT02893423|"~     With this research the investigators hope to determine the lowest dose of ropivacaine used in~     transversus abdominis plane (TAP) blocks that can effectively treat pain in women after~     cesarean section (c-section).~   "
50493|NCT02905929|"~     Project 2 of the University of California, San Diego (UCSD) American Heart Association (AHA)~     Women's Health Program will assess 3-month changes in sitting time, standing time, physical~     activity and blood pressure in a randomized control trial (RCT). This 2-arm RCT will occur in~     the community with post menopausal Latina women (N=250) who spend at least 8 hrs/day sitting~     and have increased risk for cardiovascular disease through high BMI and other cardiometabolic~     risk factors. Women will be identified through the San Ysidro Health Center and assessed at~     the South Bay Latino Research Center.~   "
50494|NCT02905916|"~     The purpose of the trail is to evaluate the efficacy and safety of PEG-rhG-CSF in primary~     prophylaxis and secondary prophylaxis of neutropenia after chemotherapy.~   "
50495|NCT02905903|"~     Post-inflammatory hyperpigmentation (PIH) is an acquired hypermelanosis that occurs after~     cutaneous inflammation or injury that frequently affects darker skinned populations.~     Previously, a model of 35% TCA-induced PIH was validated against acne induced PIH, which has~     value in product testing for the treatment of PIH. In this second phase of the study, the~     investigators would like to determine if a lower concentration of TCA-induced PIH is~     comparable to acne-induced PIH.~   "
50496|NCT02905890|"~     The proposed study, Hormonal Contraception & BV (HCBV), will investigate the effect of NET-EN~     and DMPA on recurrent BV, vaginal microbiota and inflammatory markers among women at high~     risk for HIV in Kampala, Uganda. The hypothesis is that NET-EN will show a similar beneficial~     effect on recurrent BV and vaginal microbiota as DMPA, without inducing signs of mucosal~     inflammation.~   "
50497|NCT02905877|"~     Functional disorders, also called psychogenic or psychosomatic are very common, disabling and~     their costs to society are immense.~      Functional movement disorders are abnormal, involuntary movements, that are illogical in~     terms of classic neurology. Intriguingly, they typically manifest when patients pay attention~     to them and disappear with distraction.~      The investigators aim to further the understanding of the pathophysiological mechanisms~     underlying functional neurological disorders in order to improve treatment. In particular~     they aim to understand the effect of attention on movement in general, on functional~     neurological mechanisms and on the sense of agency (of subjective control) over a movement.~      Patients with a functional neurological disorder, patients with an organic neurological~     disorder and healthy participants will perform simple tasks, such as reaching to a target,~     while additional tasks will manipulate their attention. The effects of these attentional~     manipulations will be analysed on several levels: movement performance, analysed by the~     kinematics and electromyography (EMG), psychophysical measures, such as the sense of agency,~     and the neural correlates with functional magnetic resonance imaging (fMRI).~      If the hypothesis turns out to be true, then changing the attentional focus could be used as~     a treatment in functional neurological disorders.~   "
50498|NCT02905864|"~     A randomised, double blind, placebo-controlled, parallel group, and single-centre trial~     investigating the effect of liraglutide on body weight and pain in overweight or obese~     patients with knee osteoarthritis.~      Patients will be subjected to a run-in diet intervention phase (week -8 to 0) including a~     low-calorie diet and dietetic counselling. At week 0 patients will be randomised to receive~     either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on~     re-introducing regular foods and a focus on continued motivation to engage in a healthy~     lifestyle.~   "
50499|NCT02905851|"~     To see if teledermatology can be used to reduce antibiotic burden in patients on doxycycline~     or minocycline for acne vulgaris~   "
50500|NCT02905838|"~     To assess and compare the esthetic outcome and clinical performance of anterior maxillary all~     ceramic implant single crowns based either on prefabricated zirconia abutment veneered with~     pressed ceramics or on a CAD/CAM (computer-aided design and computer-aided manufacturing)~     CARES® abutment veneered with hand build-up technique.~      Participants will be recruited from the patient population who has previously received dental~     implant treatment, received a provisional restoration and met the inclusion and exclusion~     criteria according to the study protocol. After final impression, patients will be randomised~     into Group A (prefabricated anatomic abutments ): one-piece screw retained single crown using~     a press technique (fluorapatite glass-ceramic, e.max ZirPress) with cut-back technique or~     Group B (CAD/CAM CARES® abutments): one- piece screw retained single crown with a hand~     build-up technique (fluorapatite veneering ceramic, e.max Ceram). One week after final~     restoration (base line visit) the primary and secondary outcome parameters will be assessed.~     The patients will be followed up to 5 years after final restoration.~   "
50501|NCT02905812|"~     Methodology: Pilot randomized controlled trial with 1 intervention and 1 parallel standard~     care group to assess the feasibility and treatment effect of a multimodal integrative~     intervention for delirium prevention and associated detrimental effects.~      Duration: 2 years, two months. Study Center(s): Multi-center (2 sites) Aim: To assess~     feasibility and measures of effect of a multimodal intervention consisting of relaxation with~     guided imagery (RGI), and moderate pressure massage on physiological and psychological~     outcomes of critically ill patients.~      Objectives: a) assess clinical trial feasibility with pre-defined goals (enrollment,~     randomization, adherence, timing of intervention, workload), b) calculate estimates and~     variance of treatment effect across outcome measures, c) calculate confidence intervals (CI)~     of incidence proportions, means and standard deviation (SD) of outcome measures in study~     groups., d) explore underlying physiological mechanisms of efficacy Number of Subjects: 60~     participants per arm. Total: 120 participants Diagnosis and Main Inclusion Criteria: Critical~     illness Inclusion criteria: a) Age over 18 years, b) ICDSC:0-3. Exclusion Criteria: Patients:~     a) with expected ICU LOS< 72 hours, b) with acute neurological illness/ trauma, persistent~     sedation or coma, c) with current history of severe mental health problems and dementia, as~     per history and psychiatrist assessment, c) with hearing impairment or conditions not~     permitting use of headphones, e) on neuro-muscular blockers, f) with substance/ alcohol~     withdrawal, g) enrolled in trials of sedatives, antipsychotics.~      Intervention: REPOSE intervention (a multimodal relaxation intervention) It includes: a)~     relaxation and guided imagery (RGI) (40 min, headphones), b) a brief moderate pressure~     massage session (massage: 15 min). RGI involves: a) guided relaxation, b) a structured guided~     imagery script and c) music for 15 min (Mozart piano sonata KV283, G major (2 3) II Andante).~     Duration of administration: Up to 5 days while participants still in the ICU.~      Reference therapy: Standard care plus placebo to maintain blinding. Statistical Methodology:~     Outcomes will be analyzed longitudinally over 5 days by logistic regression model based on~     generalized estimating equations (GEE) with AR(1) correlation structure. Confidence intervals~     will be presented with estimated effects. Primary analysis will be based on all available~     data utilizing data from all assessments.~   "
50502|NCT02905799|"~     The purpose of this study is to determine whether resveratrol is effective in the treatment~     of painful knee osteoarthritis.~   "
50536|NCT02905357|"~     The Women's HARP study is a multi-center, diagnostic observational study employing~     standardized imaging protocols in women with MINOCA (MI with Non Obstructive Coronary~     Arteries) to determine the underlying diagnosis in each participant. Participants will be~     followed for recurrent clinical events, every 6 months, for a maximum of 3 years.~   "
50503|NCT02905786|"~     Heart failure (HF) imposes a burden for patients and health economics. Although guidelines~     exist, they are not implemented as such in the Belgian health care system. General~     practitioners (GPs) are confronted with the broadest range of HF management. Therefore, a~     multifaceted intervention will be implemented in Belgian general practice to support GPs in~     the implementation of evidence-based HF guidelines. This multifaceted intervention will~     consist of audit and feedback as a method to detect unrecognized HF patients and increase~     awareness for proactive HF management. Additionally, a NT-proBNP point-of-care test will be~     offered to every practice to improve detection and adequate diagnosis of HF patients.~     Furthermore, a specialist HF nurse will assist GPs in education of patients, optimization of~     treatment and transition of care. The investigators' aim is evaluating the feasibility of the~     implementation of this multifaceted intervention in general practice and the evolution in~     predefined quality indicators.~   "
50504|NCT02905773|"~     The aim of this study was to evaluate the intensity and duration of postoperative pain after~     the removal of root canal filling material in retreatment procedures of upper incisor teeth~     with chronic apical periodontitis, using different techniques.~      The patients were assigned to three groups of 45 patients, according to the method used to~     remove old canal filling material. The presence of postoperative pain was assessed after 6,~     12, 24, 48, and 72 hours, 7 days, and finally after 10 days.~      The hypothesis of this study: there would be no difference in postoperative pain intensity~     among the groups.~   "
50505|NCT02905760|"~     Right ventricular necrosis increases patient in hospital mortality and can be observed in~     20-50% of patients admitted for during acute myocardial infarction. Current guidelines~     recommend managing cardiogenic shock related to right ventricular necrosis by optimizing RV~     load using fluid expansion and if insufficient adding inotropic support. However, several~     experimental studies reported a potential deleterious effect of right ventricular dilation~     related to fluid expansion because right and left ventricular interaction decreases stroke~     volume and cardiac output. Consistently with these finding, a study on a small patient sample~     conducted at Henri Mondor Hospital demonstrates the safety and efficiency of furosemide in~     patients with right ventricular necrosis.~      The present study is a phase 3, interventional, prospective, randomized, multicenter,~     double-blind analysis by intention to treat.~      The main objective is to demonstrate improved hemodynamic parameters in the short term in~     patients admitted for acute myocardial infarction with extension RV treated with furosemide.~      The primary endpoint is compare the change in cardiac output in patients admitted and treated~     by either fluid expansion or furosemide.~      The study population will consist in 88 patients and the duration of subjects' participation~     will be one month.~   "
50506|NCT02905747|"~     The aim of the project is to investigate effects of medical exercise therapy (MET) on~     patients with knee osteoarthritis. MET is a common physical therapy intervention, and the~     project aim to strengthen the evidence of this intervention. An experimental cohort design is~     chosen, and 20 participants will be followed for 6 months. Assessments will be clinical~     tests, questionnaires and accelerometer measurements before, during, and after a 3 month~     period of exercise (3 days per week) with a physical therapist. The project will answer if a~     3 month physical therapy intervention using MET causes changes in pain level, function and~     activity level for patients with knee osteoarthritis. In addition, it will investigate~     whether a single global endurance workout for 30 minutes will have an effect on pain level~     for these patients~   "
50507|NCT02905734|"~     Tobacco use affects more than 50% of adult arrestees, of which 70% are dependent on nicotine.~     However, they have no access to tobacco during detention in police cells. Nicotine withdrawal~     symptoms, that include irritability, anxiety and lack of concentration, may worsen the~     arrestee's health status during detention. Nicotine withdrawal is a treatable condition.~     Validated treatments in other situations than police custody include nicotine replacement~     therapy.~      This study is based on the following hypotheses: Manifestations related to nicotine~     withdrawal could increase the discomfort due to detention in police cells, A nicotine~     replacement therapy initiated during detention could improve the course of detention in~     police cells and could be useful in a perspective of long-lasting smoking cessation.~      The primary objective is to evaluate the efficacy of nicotine replacement therapy among~     nicotine-dependent arrestees on the course of detention as perceived by the arrestees. Our~     secondary objectives are to evaluate the efficacy of nicotine replacement therapy on desire~     to smoke during detention in police cells and to improve long-term smoking cessation among~     dependent smokers.~      Interventions consist in the single administration of an active treatment (nicotine patch) or~     of a control treatment (placebo patch). Evaluations will include the results of a medical~     examination during detention, a self evaluation by the arrestees of their desire to smoke,~     and medical consultations and evaluations of tobacco use 7-10 days, one month and six months~     later.~   "
50508|NCT02905721|"~     Spectral cardiac CT scan performed in an emergency setting in patients with suspected acute~     myocarditis and presenting one selves with an acute chest pain, allows the non-invasive~     assessment of both the coronary arteries and the myocardium. Delayed iodine contrast-enhanced~     CT imaging should show the inflamed area with an increased uptake of iodine contrast agent in~     the interstitial space, such as the well-known hypersignal seen on the myocardial delayed~     enhancement sequence with MRI (corresponding of an uptake of gadolinium contrast agent in the~     abnormal myocardium).~      This technique has the potential to replace MRI, thus allowing the diagnosis of acute~     myocarditis with a rapid and easily accessible technique. Moreover, it has the additional~     benefit of avoiding invasive coronary angiography in the specific population of patients~     without any significant risk factors of atheromatous disease.~   "
50509|NCT02905708|"~     Efficacy of Stand-alone, Non-tethered, Self-applying Warming Garment in the Preoperative,~     Intraoperative and Postoperative Recovery Period; Using an Integrated Chemical Heat Pack~     Construction, With a View to Maintaining Normothermia During the Peri-operative Period~   "
50510|NCT02905695|"~     The aim of this placebo-controlled clinical trial is to assess the effectiveness of the local~     infiltration of the analgesic Chirocaïne® on perineal pain after episiotomy or first-degree~     tear. The pain intensity is measured in immediate postpartum period by using a numerical~     rating scale (NRS) at the following times: H2, H4, H8, H12, H24, H36, H48 during rest,~     defecation and during activities. The safety of Chirocaïne® and the patient satisfaction are~     also evaluated at each time.~   "
50512|NCT02905669|"~     Impedance planimetry using Endoscopic Functional Lumen Imaging Probe (EndoFLIP) device is a~     promising diagnostic tool to assess esophageal, esophago-gastric junction and pylorus~     function. It allows the measurement of esophageal and pylorus distensibility as well as~     contractile activity in response to distension. Examination is useful performed under~     sedation. General anesthesia might affect distensibility values. The aim of this study is to~     normal values for esophageal, esophago-gastric junction and pylorus distensibility in~     controls during an upper gastro-intestinal endoscopy performed under general anesthesia.~   "
50513|NCT02905656|"~     To our knowledge, no study has evaluated the independent effects of motivational interviewing~     and rate reduction, individually versus in combination, for motivating smokers who are not~     ready to quit (SNRTQ) to increase both quit attempts and tobacco abstinence. Given the~     disseminability and the fact that findings can be readily translated into the network of~     tobacco quitlines, we propose: (1) To test a tobacco quitline for SNRTQ, following methods~     that we have previously implemented and evaluated (HL-123978, CA-127964); (2) To randomize~     828 SNRTQs to: (a) Brief Advice + typical smoking cessation resources (control group); (b)~     motivational interviewing format recommended by the Clinical Practice Guidelines; (c)~     behavioral and pharmacologic rate reduction, and (d) both motivational interviewing and~     behavioral and pharmacologic rate reduction. This design allows us to evaluate the~     independent and additive effects of motivational interviewing and rate reduction on quit~     attempts and smoking cessation.~      We plan to evaluate the efficacy of the intervention utilizing point prevalence at the~     12-month follow-up. The Society for Research in Nicotine and Tobacco consensus paper~     concluded that point prevalence (7 days without a cigarette, not even a puff) is an~     appropriate measure in measuring long term outcome in cessation induction trials. Prolonged~     abstinence at the 12-month follow-up and quit attempts at the 2-, 4- and 6-month and the~     12-month follow-up are secondary endpoints. Self-efficacy, level of smoking reduction,~     tobacco dependence, intentions, motivation, and confidence to quit, and intervention~     adherence (# sessions attended, amount of nicotine replacement therapy used) will be tested~     as important treatment mediators.~   "
50514|NCT02905643|"~     One-third of all primary brain tumors are astrocytomas, the most common type of glioma. Grade~     4 astrocytomas, more commonly known as glioblastomas (GBMs), represent about 50% of all~     gliomas (annual incidence of over 3 per 100,000) and are associated with high mortality rates~     and median patient survival of just 12-15 months post-diagnosis. Treatment response is~     assessed by measuring post-treatment tumor size on contrast-enhanced magnetic resonance~     images (MRI). However, radiation and chemotherapy cause inflammatory and necrotic changes~     which, like actual tumor progression itself, demonstrate contrast enhancement on the first~     post-treatment MRI scan. This enhancement eventually subsides (typically within 6 months of~     treatment) and is known as pseudoprogression (PsP). Currently, there is no gold standard~     noninvasive tool for distinguishing between pseudoprogression and progressive disease.~     Dynamic susceptibility-weighted contrast-enhanced perfusion MRI (DSC perfusion MRI) permits~     measurement of hemodynamic imaging variables. Previous literature reports attempted to use~     some or all of these metrics to assess their utility in distinguishing PsP from true cancer~     progression. These studies showed mixed results, likely due to a number of factors, including~     poor statistical power, poorly defined PsP, analysis of multiple cancer grades and types, and~     varied analysis methodologies. The investigators aim to address these issues in this study.~   "
50515|NCT02905630|"~     This pilot study evaluates the effect of exercise training on CFR, functional capacity, heart~     rate variability, endothelial function and quality of life in patients with no obstructive~     coronary artery disease and angina.~   "
50516|NCT02905617|"~     A 12-month study to evaluate the clinical experience with Sientra 207 Silicone Gel Breast~     Implants~   "
50517|NCT02905604|"~     The primary objective is to evaluate if repetitive transcranial magnetic stimulation (rTMS)~     with theta burst frequency over dorsomedial prefrontal cortex (DMPFC) is an effective~     treatment for negative symptoms (anhedonia and avolition) in schizophrenia or depression.~     Other objectives are to increase the understanding of the underlying neurobiology of negative~     symptoms and the mechanisms for the treatment effect of rTMS.~   "
50518|NCT02905591|"~     This clinical trial evaluates adding high-dose ascorbate (vitamin C) to a standard therapy~     for non-small cell lung cancer. The standard therapy is radiation therapy combined with~     carboplatin and paclitaxel (types of chemotherapy). All subjects will receive high-dose~     ascorbate in addition to the standard therapy.~   "
50519|NCT02905578|"~     This clinical trial adds high-dose ascorbate (vitamin C) to the standard of care regimen for~     metastatic pancreatic adenocarcinoma (a type of pancreatic cancer). All subjects receive~     high-dose ascorbate in addition to the standard treatment.~   "
50520|NCT02905565|"~     This is a Phase 2 multicenter, randomized, double-blind, placebo-controlled, add-on to~     standard of care study of NBP softgel capsules for the treatment of mild to moderate AIS in~     adults.~   "
50521|NCT02905552|"~     Myelodysplastic Syndromes (MDS) are characterized by quantitative and qualitative bone marrow~     failure and by a disorder of the medullary production which is a pre-leukemic state which can~     evolve into acute myeloid leukemia.~      The risk of leukemic transformation is estimated by the score IPSS (International Prognostic~     Score System). We distinguish the MDS of low risk (IPSS<1) and those of high risk of leukemic~     transformation (IPSS=1,5).~      Besides the risk of leukemic transformation, MDS much be complicated of infections which~     could be life-threatening.~      The risk of developing first infection after the diagnosis of MDS of high risk is probably~     influenced by anamnestic (disease duration, comorbidities), clinical (veinous central~     catheter, previous hospitalization), biological (neutropenia, lymphopenia, serum ferritin)~     and therapeutics (demethylating agent, lenalidomide, erythropoietin, G-CSF, transfusions,~     anti-infectious preventive treatment) factors. Their identification will allow for improved~     targeting of the population which is is likely to benefit from anti-infective prophylaxis~     Primary objective is to identify risk factors associated with first acute episode of~     infection in patients with MDS, by comparing index cases and matched control cases who did~     not develop infection episode since diagnosis.~      Secondary objectives are to explore nature and severity of infectious episodes, number of~     recurrences during 1 year of follow up and survival at 6 and 12 months~   "
50522|NCT02905539|"~     The purpose of this study is to determine to what extend a treatment with the iron compounds~     Iron Isomaltoside 1000 or Ferric Carboxymaltose is leading to hypophosphatemia and to study~     the potential clinical impact of hypophosphatemia.~   "
50523|NCT02905526|"~     This randomised controlled trial will establish the effect a contraceptive intervention~     delivered by mobile phone app instant messaging on use of effective contraception in Bolivia.~     Woman aged 16-24 will be randomised to have access to Centro de Investigacion, Educacion y~     Servicios's sexual and reproductive health app (control) or the app plus 0-3 instant messages~     a day for 4 months (intervention). Participants will complete a questionnaire at baseline and~     4 month follow-up.~   "
50524|NCT02905513|"~     This randomised controlled trial will establish the effect a contraceptive intervention~     delivered by mobile phone app instant messaging on the acceptability of effective~     contraception in Tajikistan. Woman and men aged 16-24 will be randomised to have access to~     the Tajik Family Planning Alliance's sexual and reproductive health app (control) or the app~     plus 0-3 instant messages a day for 4 months (intervention). Participants will complete a~     questionnaire at baseline and 4 months.~   "
50525|NCT02905500|"~     AVIRON study aims at estimating the burden of various causes of death and morbidity in the~     Reunion Island population.~   "
50526|NCT02905487|"~     ADIPOGEST study aims at comparing circulating levels of inflammatory adipocytokins and~     C-reactive protein in obese women and their newborn at delivery whether exposed or not to~     Gestational Diabetes Mellitus (GDM)~   "
50527|NCT02905474|"~     Patients with complex, long-lasting conditions such as chronic kidney disease (CKD) often~     take multiple medications and frequently have serious medication problems, arising from poor~     communication between doctors and patients. Prescription errors or misunderstandings can~     cause harm and lead to emergency room visits or even hospitalizations. To address these~     issues, medication reconciliation is now used by hospitals as a way to confirm the medication~     list of patients on admission to and discharge from hospital. However, a similar process does~     not exist outside the hospital setting. In recent years patients have become more proactive~     in undertaking activities with a direct bearing on their health. Such activities may include~     maintaining an accurate list of their medications. The rapid growth of the digital health~     arena has led to the development of a large number of commercially available mobile~     medication management apps for patients. These digital tools are 'stand-alone' products that~     are not integrated with the patients' pharmacy or health record system. They rely on patients~     to enter the list of their medications and update it as necessary. Moreover, few have a~     function to communicate medication changes or problems with their healthcare providers.~     Recently, an integrated smartphone, eKidneyCare, app system was developed with a medication~     management feature to help patients maintain an accurate mobile medication list. Patients'~     current medication information in the pharmacy database is uploaded onto their by a~     pharmacist and changes are tracked regularly through a bi-directional communication system.~     Updates to the medication list occur seamlessly by the pharmacist, and patients and their~     physicians are notified about any medication errors or serious adverse events. This study~     will determine whether our eKidneyCare app with its medication management feature will~     decrease medication errors and improve patient safety compared to the more traditional way of~     managing medications.~   "
50528|NCT02905461|"~     This randomised controlled trial will establish the effect a contraceptive intervention~     delivered by mobile phone text message on the acceptability of effective contraception in~     Palestine. Woman aged 18-24 will be randomised to receive 0-3 text messages a day for 4~     months (intervention) or a monthly text message not about contraception (control).~     Participants will complete a questionnaire at baseline and 4 month follow-up.~   "
50529|NCT02905448|"~     The effect of a diet free from animal-sourced nutrients on a variety of risk factors for~     chronic non-communicable diseases in weight reduction programs is not well established. In~     this non-randomised interventional study, the investigators will document the effects of a~     low-fat, plant-based diet supplemented with two daily plant-based meal replacements on serum~     LDL cholesterol as a primary end-point and total cholesterol, triglycerides, serum fasting~     glucose, serum urate, serum insulin-like growth factor 1 (IGF-1) and body fat mass as~     secondary end-points. These end-points will be measured at baseline, after 10 weeks and after~     30 weeks of intervention. Participants will be enrolled in the interventional arm with~     prescribed low fat plant-based diet from the group of all applicants to a free living~     population-based diet optimising program. The choice to participate in the study will be made~     by participants themselves.~      The investigators hypothesise that low-fat plant based diet supplemented with plant-based~     meal replacements eaten ad libitum allows a significant reduction of serum LDL cholesterol~     concentration.~   "
50530|NCT02905435|"~     This is a multi-center, single arm, traditional feasibility study to allow a preliminary~     assessment of the safety and effectiveness of a new method of treating skin burns using~     Biodegradable Temporizing Matrix (BTM).~   "
50531|NCT02905422|"~     The proposed study aims to combine evidenced based tools and guidance (H.E.A.L.T.H.: Healthy~     Eating Activity Lifestyle Training Headquarters) previously tested that has been developed~     specifically for use by Army Soldiers and a remote clinical intervention model that includes~     mobile tracking technology/devices for physical activity, weight and nutrition. This program~     is called the H.E.A.L.T.H. Intensive.~   "
50532|NCT02905409|"~     The purpose of this study is to determine the effects of two different internal limiting~     membrane peeling with distinct diameters on anatomical closure grades after macular surgery~     measured by OCT (optical coherence tomography.).~   "
50533|NCT02905396|"~     Small fibre neuropathy (SFN) is a disorder in which selectively thinly myelinated and~     unmyelinated nerve fibres are involved. SFN can cause severe and chronic symptoms such as~     burning pain in the extremities in combination with autonomic symptoms. So far, the results~     of symptomatic SFN treatment have been rather disappointing, despite the fact that new agents~     have been developed.~      This study is a pilot study to investigate whether Spinal Cord Stimulation (SCS) combined~     with best (drug) treatment as usual (TAU) leads to clinically significant pain relief in~     patients suffering from pain in the lower limbs due to SFN, defined as ≥30% pain reduction on~     a mean NRS during daytime, and/or ≥30% pain reduction on a mean NRS during night-time, and/or~     at least much improved or very much improved, on the Patient Global Impression of Change~     (PGIC) for pain and sleep.~   "
50534|NCT02905383|"~     The aim of this study is to investigate the effect of a multi-component exercise program on~     physical function, physical activity and health-related quality of life (HRQOL) in older~     people recently discharged from hospital. The intervention consists of 32 group-based~     exercise sessions, performed twice a week. In addition the participants in the intervention~     group will be encouraged to perform an exercise program on their own, at least once weekly.~     The participants in the control group will be encouraged to exercise on their own, according~     to the World Health Organization (WHO) recommendations on physical activity for adults aged~     65 and above.~   "
50535|NCT02905370|"~     This research study explores the effects of a progressive, multi-component intervention~     following a stay in the hospital or rehabilitation facility. The purpose of this research~     study is to compare a multi-component intervention (higher intensity exercise, nutritional~     supplementation, and greater emphasis on functionally enhanced care transitions) with usual~     care physical therapy.~   "
50537|NCT02905344|"~     Within the Ear, Nose, and Throat (ENT) medical space, a relatively small number of patients~     follow through with elective surgeries to fix ailments like a deviated septum or occluded~     sinus passage. Patient understanding of their diagnosis and treatment plan is integral to~     compliance, which ultimately yields improved medical outcomes and better quality of life.~     Here the investigators report the usage of advanced inkjet 3D printing methods to develop a~     multimaterial replica of the patient's nasal sinus anatomy, derived from clinical X-ray~     Computed Tomography (CT) data. The final patient education model was developed over several~     iterations to optimize material properties, anatomical accuracy and overall display. A two~     arm, single center, randomized, prospective study was then performed in which 50 ENT surgical~     candidates (and an associated control group, n = 50) were given an explanation of their~     anatomy, disease state, and treatment options using the education model as an aid. Each~     patient was then surveyed for their self-rated understanding of their anatomy, disease, and~     treatment options.~   "
50538|NCT02905331|"~     The purpose of the study is to evaluate the efficacy, safety, pharmacokinetics,~     immunogenicity, usability, and acceptability of guselkumab delivered using SelfDose device in~     participants with moderate to severe plaque-type psoriasis.~   "
50539|NCT02905318|"~     The purpose of this study is to find out what effects a new drug, palbociclib, has on~     prostate cancer and will look at the side effects of treatment with palbociclib. The~     researchers doing this study are also interested in looking for markers that may help predict~     which patients are most likely to be helped by palbociclib and to see how the cancer cells~     respond to palbociclib.~   "
50540|NCT02905305|"~     In an effort to further preserve residual acoustic hearing after cochlear implantation, it~     may be beneficial to incorporate anti-inflammatory agents into the electrode array for~     passive elution over a time course after implantation. This study aims to assess the ease and~     effectiveness of such an electrode design, and to assess the preliminary safety of use of~     such a device in the post-operative period. This study is a first-time-in-human study of the~     investigational device.~      In the first instance, the aim of the current investigation is to obtain first experience in~     use of a Combined Device in the adult clinical population, and to assess tools and techniques~     that may be considered in future clinical studies of similar devices.~   "
50541|NCT02905292|"~     The overall objective of the research is to identify the prevalence and incidence of BPPV and~     the impact on balance problems, fall risk and inactivity in frail elderly. The investigators~     will demonstrate the importance of early diagnosis and treatment in this patient group.~   "
50542|NCT02905279|"~     This study tests the effectiveness of exposure therapy for fear of spiders as enhanced by the~     use of antagonistic or opposite actions during treatment. The goal of the study is to compare~     the efficacy threat-relevant opposite actions and threat-irrelevant opposite actions in~     extinguishing fear.~   "
50543|NCT02905266|"~     This is a safety and efficacy study of different administration regimens of nivolumab plus~     Ipilimumab in subjects with previously untreated, unresectable or metastatic melanoma.~   "
50544|NCT02905253|"~     The primary purpose of this first-in-man study is to investigate whether AC-084 is safe and~     well-tolerated when orally administered at single- and multiple-ascending dose to healthy~     adults~   "
50545|NCT02905240|"~     A double-blind, multicenter, randomized, controlled trial (RCT) that will evaluate the~     efficacy of a single dose of Autologous Protein Solution (APS) in patients with~     Osteoarthritis (OA) of the knee.~   "
50546|NCT02905227|"~     This study is an open-label, parallel group study to evaluate acute pulmonary safety and~     Pharmacokinetics (PK) of two doses, separated by 2 hours, of CVT-427 zolmitriptan inhalation~     powder in three groups of adults: those with asthma, those who smoke and healthy volunteers.~   "
50547|NCT02905214|"~     Postmarket surveillance in terms of the safety and efficacy of Sirolimus-eluting Coroflex~     ISAR Stent for the treatment of real world patients with de-novo and restenotic lesions~     after stand-alone angioplasty in coronary arteries.~   "
50548|NCT02905201|"~     The primary purpose of this study is to determine the rate of compliance to abiraterone~     acetate and prednisone (AA + P) treatment in Colombian Castration-resistant metastatic~     prostate cancer (mCRPC) participants experiencing adequate response to treatment, in a~     real-world clinical setting.~   "
50549|NCT02905188|"~     This study enrolls patients who have a type of cancer that arises from the liver called~     hepatocellular carcinoma. The cancer has come back, has not gone away after standard~     treatment, has spread outside of the liver or the patient cannot receive standard treatment.~     This research study uses special immune system cells called GLYCAR T cells, a new~     experimental treatment.~      The body has different ways of fighting infection and disease. No single way seems perfect~     for fighting cancers. This research study combines two different ways of fighting cancer:~     antibodies and T cells. Antibodies are types of proteins that protect the body from~     infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special~     infection-fighting blood cells that can kill other cells, including cells infected with~     viruses and tumor cells. Both antibodies and T cells have been used to treat patients with~     cancers. They have shown promise, but have not been strong enough to cure most patients.~      Investigators have found from previous research that they can put a new gene into T cells~     that will make them recognize cancer cells and kill them. In preclinical studies, the~     investigators made several genes called a chimeric antigen receptor (CAR), from an antibody~     called GC33 that recognizes glypican-3, a protein found on almost all hepatocellular~     carcinoma cells (GPC3-CAR). This study will test T cells genetically engineered with a~     GPC3-CAR (GLYCAR T cells) in patients with hepatocellular carcinoma.~      The GLYCAR T cells are an investigational product not approved by the Food and Drug~     Administration.~      The purpose of this study is to find the biggest dose of GLYCAR T cells that is safe, to see~     how long they last in the body, to learn what the side effects are and to see if the GLYCAR T~     cells will help people with GPC3-positive hepatocellular carcinoma.~   "
50550|NCT02905175|"~     Rheumatoid arthritis (RA) is the most frequent joint inflammatory disease inducing joint~     destruction strongly correlated with anti-citrullinated protein antibodies citrullinated~     anti-peptide (ACPA). Precise RA etiology remained unclear with a described association~     between RA and periodontal disease. The missing link could be a gram-negative anaerobic~     bacterium called Porphyromonas gingivalis (P. gingivalis), which is heavily involved in~     periodontal disease and able to induce gingival citrullinated protein via an enzyme called~     peptidyl arginine deiminase (PAD). DNA of P. gingivalis was detected in synovial tissue and~     in peripheral blood mononuclear cell. To improve knowledge of P. gingivalis involvement in~     RA, the investigators will compare its effect on various cell type with comparison with~     another oral bacteria Provatella intermedia.~   "
50599|NCT02904538|"~     Both perineural and systemic dexamethasone administration allows an increase in analgesic~     duration of regional anesthesia.~      There is a lack of data to determine wich route allows a longer analgesic effect.~      This study aims to determine wether perineural dexamethasone allows a longer analgesic~     duration than systemic route in combination with regional anesthesia (Ropivacaine 0.375%) for~     front foot surgery.~   "
50551|NCT02905162|"~     To inform the design of a future transitional HIV care intervention for releasees, the study~     proposes to prospectively assess clinical outcomes for HIV-infected prisoners after release;~     explore factors from health behavior theory that are associated with post-release retention~     in care, with a special focus on Alcohol Use Disorders (AUDs); and conduct formative research~     to determine releasee and stakeholder knowledge, attitudes, and preferences surrounding~     transitional care interventions.~   "
50552|NCT02905149|"~     The purpose of this project is to evaluate the analgesic efficacy of a regional anesthesia~     technique ( interfascial block at the serratus muscle) performed in patient undergoing breast~     surgery and the effect of this technique on postoperative analgesia.~   "
50553|NCT02905136|"~     Neurological and psychiatric diseases are one of the major health problems worldwide. Decades~     of fundamental and clinical research have led to the model that these disorders results from~     synaptic imbalance between excitatory, inhibitory and modulatory systems in key brain~     structures. Although the network and neurotransmitter systems involved have been delineated,~     the mechanisms leading to improper neurotransmissions remain poorly understood. One major~     limitation lays in the difficulty to transpose the identified dysregulation in humans to~     relevant animal models in which molecular and cellular targets can be manipulated.~      The amino-acid glutamate mediates the vast majority of excitatory neurotransmission in the~     mammalian brain. We know that the glutamatergic synapses can change their strength by~     regulating surface expression and dynamics of their postsynaptic receptors, through changes~     in receptor recycling and/or lateral diffusion. This synaptic plasticity underlies higher~     cognitive functions such as learning and memory and is likely compromised in several disease~     states. Regulating glutamate receptor number and function is thus of primary importance. New~     subcellular imaging technique rendered possible the study of receptor trafficking and~     receptor regulation in various conditions including pathological models opening new~     fundamental questions. Moreover, recent breakthroughs on glutamate receptor structure offer~     unprecedented clues on the molecular and structural mechanisms underpinning receptor~     dysfunction at the atomic level.~      Recently, description of encephalitis associated with specific autoantibodies (Abs) directed~     against neuronal synaptic receptors or proteins (NSA-Abs) opens new lights in the~     pathophysiological mechanisms of some human brain disorders. The best example and the most~     frequent syndrome is the synaptic autoimmune encephalitis associated with autoantibodies~     against extracellular domains of the glutamatergic NMDA receptor (NMDAR-Abs). Classically,~     patients first present psychiatric symptoms with hallucinations and bizarre behavior before~     development of neurological symptoms such as seizures, dyskinesia, and autonomic instability.~     Despite the severity of neuropsychiatric symptoms, more than 80% of patients fully recover~     after immunomodulatory treatments and many arguments suggest a direct role of NMDAR-Abs in~     the symptoms. The investigators recently demonstrated that NMDAR-Abs directly modify, at the~     synaptic level, NMDAR lateral diffusion by disruption of the interaction between NMDAR and~     EphrinB2 receptor, a synaptic protein anchoring NMDAR at the synapse (Mikasova et al, Brain~     2012; Dupuis et al, EMBOJ 2014). These data suggest that NMDAR-Abs could directly participate~     in the neuropsychiatric disorders observed in patients and that NMDAR dysfunctions could be~     directly responsible for the observed symptoms. Furthermore, these data suggest that other~     NSA-Abs directed against other synaptic proteins could explain specific neurological symptoms~     in patients with encephalitis that are not associated with NMDAR-Abs.~      The aim of MECANO is to combine multidisciplinary approaches (clinical, immunological, and~     neurobiological ones) to identify new NSA-Abs, to characterize their specific pathological~     roles and to decipher acute and chronic NMDAR-Abs effects on biophysical and structural~     properties of the NMDA receptor, synaptic plasticity, neuronal morphology, and cognitive~     performance. This project should provide key insights onto the effects of patients' NSA-Abs~     on the cellular dynamic and regulation of synaptic proteins or receptors and on the molecular~     cascades activated during synapse dysfunction. The investigators will investigate how NSA-Abs~     binding alter receptor activity, modify surface receptor mobility and dynamically regulate~     the maturation of synapses and circuitries. For that purpose, The investigators will use a~     unique combination of high-resolution imaging (single nanoparticle tracking), receptor~     engineering, cellular electrophysiology, computational (structural modeling) and cellular and~     molecular biology approaches and finally behaviour assays. Based on both cutting-edge~     neurobiology and clinical expertise of autoimmune disorders, and strengthened by promising~     preliminary experiments, the MECANO project will likely open new avenues of fundamental~     research in the understanding of synaptic dysfunction and clinical research for the treatment~     of neuropsychiatric disorders.~   "
50554|NCT02905123|"~     Amazon's Mechanical Turk (MTurk) is an online platform that has become a popular means of~     recruiting participants with problem drinking, gambling, or even illicit drug use for the~     purposes of survey-based research. There is also the possibility that potential participants~     could be identified through MTurk for online longitudinal studies, including for brief~     intervention research. The potential to quickly and easily identify large numbers of~     participants through MTurk is important for research evaluating online interventions during~     the period that these interventions are being developed and refined. However, before~     proposing MTurk workers as a viable source for participants in online intervention trials, it~     is important to evaluate the feasibility of using MTurk for such a purpose. This pilot study~     proposes to test this feasibility by systematically replicating a trial of an extensively~     evaluated brief online intervention for hazardous alcohol use (CheckYourDrinking; CYD) and~     will attempt to recruit and follow-up participants for this replication using people~     recruited through MTurk.~      Participants will be recruited through Amazon's MTurk crowdsourcing platform. Participants~     identified as problem drinkers based on an initial survey will be invited to complete another~     survey in 3 months time. Those who are interested will be randomized to receive access to the~     Check Your Drinking screener (CYD condition) or to a no additional information condition~     (control condition). At three-months post-baseline, the MTurk portal will be used to send~     invitation emails that contain a link to the follow-up survey. The primary hypothesis to be~     tested is that participants receiving access to the CYD intervention will report a greater~     level of reduction in number of drinks in a typical week between the baseline survey and~     three-month follow-up as compared to participants in the no information control condition.~   "
50555|NCT02905110|"~     The goal of this clinical research study is to establish the safety of simultaneous infusions~     of methotrexate and etoposide into the fourth ventricle of the brain or resection cavity in~     patients with recurrent malignant posterior fossa brain tumors. These tumors include~     medulloblastoma, ependymoma, atypical teratoid/rhabdoid tumor or other malignant brain tumor~     with recurrence or progression involving anywhere in the brain and/or spine. Patients'~     disease must have originated in the posterior fossa of the brain.~   "
50556|NCT02905097|"~     The aim of the study is to assess the performance of the cementless Triathlon Tritanium~     tibial baseplate for total knee replacement, with a minimum follow up of 5 years.~   "
50557|NCT02905084|"~     The environment of the ICU and operating room allows the multi continuous monitoring of~     patients in critical situations. The physician anesthesiologist is working more and more in~     an environment where he receives a multitude of information from both the patient's medical~     history but also measured data in real time to its physiological situation. It is sometimes~     difficult for practitioners to consider all of the information by identifying a course of~     action. A decision support and a degree of automation can increase security along the lines~     of what has been observed in many processes and industries like aviation.~      The goal of this project is to establish initially a database of physiological parameters. We~     want to use patient data to model physiological processes in order to advance towards the~     creation of physios program,~   "
50558|NCT02905071|"~     The main objective of this work is to explore the psychometric properties of scale of~     well-being at work called Serenat in order to validate it. Secondary objectives are to~     study the influence of socio-demographic characteristics of the subjects on the results of~     Serenat and to describe the results on subjects monitored among an adult psychiatric~     population.~   "
50559|NCT02905058|"~     IUD can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix~     and straighten the uterus for proper insertion; trans-cervical actions including measuring~     uterine depth, inserting the IUD insertion tube, and removing the tube; and placement of the~     device in the uterus.~   "
50560|NCT02905045|"~     hysterosalpingography can cause pain and discomfort in several ways: Use of the tenaculum to~     grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions~     including measuring uterine depth, inserting the cannula; and injection of the dye~   "
50561|NCT02905032|"~     The objective of this project is to evaluate a treatment decision aid for patients with~     atrial fibrillation.~   "
50562|NCT02905019|"~     The purpose of this study is to assess the safety and efficacy of adjuvanted R21 alone and in~     combination with a viral-vectored vaccine regimen (constituting adjuvanted R21 + ChAd63 and~     MVA encoding ME-TRAP) against malaria sporozoite challenge in healthy malaria-naive~     volunteers.~      Healthy adult volunteers will be recruited in London, Oxford and Southampton.~      All vaccinations will be administered intramuscularly. The study involves having either two,~     three or five vaccinations and then undergoing challenge infection with malaria, or receiving~     no vaccinations then undergoing challenge infection with malaria.~   "
50563|NCT02905006|"~     This is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled,~     parallel-group, dose ranging study to investigate the safety, efficacy, pharmacokinetics~     (PK), and pharmacodynamics (PD) of Bimekizumab compared with placebo in adult subjects with~     moderate to severe chronic plaque psoriasis in order to guide the selection of doses and~     clinical indices in the Phase 3 development program.~   "
50564|NCT02904993|"~     To compare two methods of post-operative pain management in patients undergoing total hip~     arthroplasty. There is a perception that the periarticular injections may not be as effective~     in controlling post-operative pain.~      Both methods are current standard of care. The investigators want to compare the outcomes of~     each when patients are randomized to one of the methods compared to the other method of~     post-operative pain control.~   "
50565|NCT02904980|"~     The aim of this study was to integrate a gaze training intervention (i.e., quiet eye~     training; QET) that has been shown to improve the throwing and catching skill of children~     with Developmental Coordination Disorder (DCD), within an approach (i.e., group therapy) that~     might alleviate the psychosocial influence of these motor skill deficits.~   "
50611|NCT02904369|"~     This multi-center Phase I study is designed to characterize the PK and PD of F/TAF oral~     tablets to assess systemic and genital tract bioavailability in healthy women. The oral~     tablets to be used in the study are F/TAF (200/10 mg), F/TAF (200/25 mg) and F/TDF (200/300~     mg, Truvada). Samples will be obtained before, during and after dosing in two study phases.~   "
50566|NCT02904967|"~     Venous thromboembolism (VTE) is a common and potentially fatal disease. It is considered a~     chronic disease with a recurrence rate of 30% at 10 years.~      Reduce the risk of recurrence is a serious public health issue. For this it is necessary to~     identify patients at high risk of recurrence. However, until now, only 50% of recurrences are~     in the presence of known risk factors, suggesting that there are still yet unidentified risk~     factors.~      The assumption behind this project is that there are specifically associated genetic~     polymorphisms to the risk of VTE recurrence.~      The aim of our project is to identify these polymorphisms from genome-wide data MARTHA~     cohort. This cohort is composed of 1542 subjects from the Marseille region with at least one~     episode of VTE documented. Patients in the cohort MARTHA have all been genotyped for~     approximately 500,000 polymorphisms.~      The investigators want to achieve a case-control study nested in the cohort MARTHA. Subjects~     with recurrent VTE (the case) will be compared to subjects with only one episode of VTE (the~     controls). The allelic frequencies of polymorphisms previously genotyped 500,000 will be~     compared between cases and controls. The identification of these new genetic variants~     associated with VTE recurrence should allow us to improve the pathophysiological knowledge of~     the disease, reduce the frequency of episodes and focus research on new therapeutic~     approaches.~   "
50567|NCT02904954|"~     The purpose of this study is to find out the effectiveness of the drug durvalumab (MEDI4736)~     with or without stereotactic body radiation therapy (SBRT) as treatment for stage I (tumors >~     2cm), II, and IIIA non-small cell lung cancer (NSCLC) prior to surgery and one year following~     surgery.~   "
50568|NCT02904941|"~     This is a randomised trial that aims to evaluate whether a transient skin cover made out of~     human amniotic membranes is effective in managing burns among pediatric patients. The primary~     outcome of this trial is the proportion of skin grafted amongst participants. Secondary~     outcomes include hospital stay and the number of surgical debridements required by included~     patients.~   "
50569|NCT02904928|"~     With the increasing number of advanced surgical operations being done annually, including the~     elderly, the risk of developing postoperative delirium is potentially high. Postoperative~     delirium is associated with longer hospital stay, poorer functional outcome, cognitive~     decline and an elevated morbidity and mortality, in addition to an increased cost of health~     care. However, most of the studies on postoperative delirium have been done in high income~     countries, leaving a paucity of literature on the incidence and associated factors of~     postoperative delirium in Africa and hence a need to do this study.~   "
50570|NCT02904915|"~     The purpose of this study is to compare the pain level and level of discomfort with~     paracervical block versus no analgesia in women who present to the University of Texas (UT)~     Physicians Obstetrics and Gynecology Continuity Clinic, The UT Physicians Women's Center, and~     the UT Physicians Women's Center- Bellaire for IUD insertion.~   "
50571|NCT02904902|"~     This study investigates efficacy, safety and pharmacokinetics of adalimumab in Japanese~     subjects with moderate to severe Hidradenitis Suppurativa (HS).~   "
50572|NCT02904889|"~     Most older adults want to stay at home for as long as possible. To reach this aim it is~     important to maintain their mobility and self-care abilities. However, many older adults are~     at risk to lose their abilities, as they have an inactive lifestyle. In this study, homecare~     professionals learn to motivate their clients to be more active in daily and physical~     activities. Examples of these activities are washing and dressing, household chores or going~     for a walk.~      The primary aim of this exploratory study is to evaluate the implementation of the 'Stay~     Active at Home' program (process evaluation). The secondary aim is to get insight into the~     potential effectiveness of the program with regard to several primary and secondary outcomes~     measures (effect evaluation). The tertiary aim is to test the feasibility of the proposed~     study design.~   "
50573|NCT02904876|"~     Through this phase IV study, multicenter prospective exploratory, uncontrolled, the~     investigators propose to identify MRI predictive factors of treatment response, using~     diffusion MRI sequences, in addition to conventional sequences.~      The primary objective is to study the links between changes on MRI diffusion and response to~     treatment with Tysabri to 2 years.~      The secondary objective is to compare the evolution of diffusion MRI data with the volumetric~     MRI data.~   "
50574|NCT02904863|"~     The Hemolytic Uremic Syndrome (HUS) is a rare thrombotic microangiopathy (TMA), affecting~     both children and adults. HUS is characterized by the abnormal occurrence of diffuse~     thrombosis in the microcirculation resulting in the occurrence of ischemic events affecting~     especially the kidneys and is associated with hemolytic anemia. One of the major problems~     encountered in the management of HUS is the absence of reliable marker of treatment response~     or relapse; conventional hematological markers being too insensitive to judge therapeutic~     efficacy or identify early relapse. Data from the literature suggest that the endothelial~     cell is a major target of this syndrome. Our hypothesis is that an initial micro-endothelial~     activation plays a critical role in the initiation and / or relapse of the disease.The main~     objective of this study is to define a vascular competence profile in a population of~     patients with typical or atypical HUS; both in the acute phase and in remission of the~     disease.~   "
50575|NCT02904850|"~     Several arguments are in favor of a therapeutic monitoring for the erlotinib, therefore, a~     pharmacokinetic (PK) has been prepared using data from the literature. This model must be~     validated at concentrations achieved in practice. This is a preliminary study before the~     implementation of a randomized trial confirming the therapeutic monitoring of erlotinib~     through this model.~   "
50576|NCT02904837|"~     Among the impairments associated with Parkinson's disease (PD), gait disturbance is one of~     the most injurious to the independence in daily living activities and the quality of life of~     people living with Parkinson's disease (PPD). Despite a considerable amount of research,~     there is no consensus about the most efficient physiotherapeutic approach to improve gait~     disturbance. Mental practice (MP) is considered an efficient strategy to improve the motor~     performance of healthy individuals and people with stroke. However, there is little evidence~     about its therapeutic results as a tool to improve gait performance in PPD. Thus, the aim of~     this study is to investigate the effects of mental gait practice associated with physical~     practice (PP) to improve the gait performance of PPD.~   "
50612|NCT02904356|"~     The study aims to assess the impact of repetitive transcranial magnetic stimulation (rTMS) on~     brain imaging and neurophysiological measures of cognitive control in patients with~     Obsessive-Compulsive Disorder (OCD).~   "
50577|NCT02904824|"~     This is the first Development Safety Update Report prepared for Phase I-IIA Clinical Trial-~     FIBHGM-ECNC007-2010 (PHASE I / IIA CLINICAL TRIAL, UNICENTRIC, RANDOMIZED, CONTROLLED, TWO~     PARALLEL-GROUPS, TO EVALUATE THE SAFETY OF A NEW THERAPY WITH STEM CELLS DERIVED FROM ADIPOSE~     TISSUE FOR GLOTTAL GAP(GG) IN THE UNILATERAL PARALYSIS OF THE VOCAL CORD(VC) ) in the~     International Conference on Harmonization (ICH). Patients are randomized to receive one of~     the following therapeutic strategies:~      Group A: Autologous Fat processed by centrifugation to fill a paralyzed vocal cord. Group B:~     Autologous Fat enriched with stem cells from adipose tissue to treat vocal cord paralysis.~      Active control: Autologous fat tissue processed by centrifugation. Route of administration:~     Injection into a paralyzed vocal cord.~      Experimental drug: Stem cells from autologous adipose tissue in which autologous tissue is~     enriched or in suspension to fill the paralyzed vocal cord. The aim is to induce the~     overexpression and production of microvessels at local level. Route of administration:~     injection into the thickness of a paralyzed vocal cord.~   "
50578|NCT02904811|"~     The main objective of the study is to determine whether early screening and treating young~     women (<25 years of age) for genital Chlamydia Trachomatis (Ct) infection reduces the~     cumulative incidence of pelvic inflammatory disease (PID) over 24 months.~      As secondary objectives, the study aims~        -  To determine the baseline prevalence and the incidence of Ct infection;~        -  To improve knowledge on natural history of Ct infection in young women such as the rate~          and timing of progression to PID (at the beginning of the infection, at the end,~          throughout the course of infection), as well as the incidence of reinfections with Ct;~        -  To investigate the relation between host immuno-genetic factors and the clearance,~          persistence and development of late complications (PID) as an explanation for the~          inter-individual heterogeneity in the susceptibility to and course of Ct infection.~   "
50579|NCT02904798|"~     Polypodium Leucotomos Extract (PLE) is a tropical fern that has antioxidative,~     photoprotective, chemoprotective, anti-inflammatory, and immunomodulatory properties. The~     antioxidative effects of PL include inhibition and scavenging of free radicals, lipid~     peroxidation and reactive oxygen species (ROS) such hydrogen peroxide, superoxide anion,~     hydroxyl radical and singlet oxygen. Visible light (400-700 nm) causes pigmentation in~     melanocompetent individuals and induces DNA damage in the human skin through ROS production.~     The goal of this study is to determine whether the administration of oral PLE has an effect~     on the development of visible light induced pigmentation.~   "
50580|NCT02904785|"~     The purpose of this study is to determine whether Extracorporeal Focused Shock Wave Therapy~     reduces knee pain and enhance function in patients with primary knee osteoarthritis.~   "
50581|NCT02904772|"~     The aim of the study is to provide further confirmatory evidence of clinical benefit in LPLD~     patients treated with alipogene tiparvovec by assessing both the clinical response (as~     defined by a range of parameters), and the metabolic response (postprandial CM metabolism)~     in LPLD patients with and without an immunosuppressant regimen.~   "
50582|NCT02904759|"~     The purpose of this trial is to demonstrate efficacy of desmopressin ODT against placebo for~     the treatment of male subjects with nocturia due to nocturnal polyuria, during 12 weeks of~     treatment.~   "
50583|NCT02904746|"~     This study will evaluate the preliminary effectiveness of Make It!, a single 15-minute~     intervention aimed at increasing attendance to a follow-up appointment for psychological~     services (i.e., an information class) among clients accessing walk-in services at a mental~     health crisis response centre. As a secondary aim, we will examine the demographic~     correlates, presenting problems, and symptom correlates of clients who do and do not attend~     follow-up services.~   "
50584|NCT02904733|"~     A large (3900 patients) cohort study, undertaken in five European sites to validate in a~     mHealth platform to enable self-management of HIV in patients with stable disease using a~     tailored HTA process, Model for Assessment of Telemedicine Applications (MAST), specifically~     developed for the assessment of mHealth solutions.~      As site recruitment will be sequential and the recruitment period will last 18 months, a~     maximum follow-up of 35 Months will be undertaken. Study visits will take place at baseline~     defined as the time of mHealth introduction, months 6, 12, 18, 24 and 30.~   "
50585|NCT02904720|"~     The purpose of this study is to determine the prevalence of vitamin D deficiency among the~     population of pregnant women receiving prenatal care and giving birth at the investigators'~     clinic. The further purposes are to identify the population at risk for vitamin D deficiency~     and to analyse whether vitamin D deficiency is associated with pregnancy complications.~   "
50586|NCT02904707|"~     Leg ulcers (UDJ) is defined as a chronic skin wound, lasting for more than 4 to 6 weeks,~     between the knee and foot, and with no tendency to spontaneous healing.~      In 2002, the prevalence of leg ulcers is estimated between 0.5% and 1% of the general~     population and 3% in subjects over 65 years.~      The sex ratio is generally 3 females to 1 male. It is in most cases a complication of~     vascular disease, usually venous (70 to 90%), then blood (5-15%), mixed (5-10%) and~     microcirculatory.~      In three quarter of cases, the UDJ is a chronic painful wound to the social repercussions~     (sleep disorders, eating, work stoppages) and major economic (individual and collective costs~     of absorptions).~      The treatment of a chronic wound uses validated techniques for several years as the skin~     graft in tablets, associated with the etiological treatment.~      The latest recommendations HAS implemented to date from 2006 and concerns the management of~     leg ulcers predominantly venous.~      Few articles in the literature address the possibility of an analgesic effect of the~     transplant pellets in the treatment of chronic ulcers algic.~      In 2008, a Swedish article, evaluated pain before and after skin grafting in carriers of leg~     ulcer patients and feet and showed that there was a reduction in pain post transplant.~      We propose to evaluate the analgesic effect of the skin graft in pellet on a patient~     population having one or more Algic ulcers.~   "
50608|NCT02904421|"~     The study aimed to:~        1. To investigate and compare the changes in bone mineral density (BMD), trabecular bone~          micro-architecture, bone strength, and curve severity at a mean of 6 years longitudinal~          follow up in AIS girls with low bone mass between Group A and B:~             1. Group A: subjects followed at a mean of 4 years after completion of 2-year calcium~               and Vit-D supplementation and~             2. Group B: subjects without calcium and Vit-D supplementation~        2. To evaluate the correlation between changes in BMD, trabecular bone micro-architecture,~          and bone strength documented in Objective 1 with changes in serum bone turnover markers~   "
50587|NCT02904694|"~     A national database is being set-up to collate clinical outcome information before and after~     children undergo Selective Dorsal Rhizotomy (SDR). SDR is a surgical procedure that has been~     used for many years but has not been routinely available within the United Kingdom National~     Health Service (NHS). The SDR procedure is used to improve spasticity in children with~     cerebral palsy and involves dividing some of the nerve fibres running from the muscles back~     to the spinal cord. While it is believed that SDR is effective, there are no definitive data.~     In July 2014 NHS England commissioned five NHS Trusts to undertake SDR surgery in eligible~     children for a two-year period, and to collect detailed information on their outcomes. The~     proposed database will aggregate these data from the five centres and analyse them to provide~     overall evidence on the clinical effectiveness of SDR. This information will be used to~     inform future commissioning decisions. The database has been developed by the King's~     Technology Evaluation Centre (KiTEC) in conjunction with NHS England and the national~     clinical SDR steering committee and its data subcommittee. KiTEC undertakes research~     evaluations for the National Institute for Health and Care Excellence (NICE), and has been~     commissioned by NICE to undertake this work. Clinicians in the SDR data subgroup have liaised~     closely with KiTEC to agree which data to collect so that it the least amount needed and will~     be in a standardised format across all centres. When all two-year outcome data are recorded,~     KiTEC will analyse the data and present a report to NHS England, NICE and the SDR steering~     committee and data sub-group. While there are no firm plans to follow the children beyond two~     years post-surgery, all parties involved are hoping that further funding can be obtained to~     continue following these children up as these data will be unique.~   "
50588|NCT02904681|"~     Spinal growth dystrophy (CRD), also called Scheuermann's disease, corresponding to impaired~     vertebral structure occurring in children and adolescents with involvement of the growth~     cartilage causing impaired growth and kyphosis.~      There are forms thoracolumbar and thoracic conventional forms of DRC with variable clinical~     expressions; the most important being kyphosis with spinal stiffness associated with painful~     elements.~      The radiographic definition according Sorenson is uniformisation 5 ° affecting at least three~     adjacent vertebrae.~      Scheuermann's disease and three problems. First, the thoracic kyphosis generates back pain~     which may be thoracic or lumbar indirectly attributed to compensatory lordosis. Moreover~     disruption sagittal balance frequently causes a significant aesthetic discomfort. Finally,~     scalability because the curvature may increase the likelihood of degenerative lesions disc~     degeneration or lumbar spinal stenosis for example.~      When the disease is diagnosed early, treatment is most often associated with orthopedic~     physiotherapy. However, for patients with active deformation, despite an orthopedic brace~     treatment with chronic pain, neurological deficit or for aesthetic reasons, surgical decision~     can be taken.~      The goal of surgical treatment of DRC is a correction of the thoracic kyphosis. It goes~     through a spinal fusion must be released from his column stiffness in a bad position,~     changing the equilibrium profile and ensure that it remains in a good position.~      This surgery usually requires a prior operative time (thoracic surgery to remove the~     intervertebral discs) and a posterior surgical time (blockage of the vertebrae together with~     a bone graft and osteosynthesis). Currently different surgical strategies are practiced there~     is no real consensus between the teams.~   "
50589|NCT02904668|"~     Neck pain is a complex biopsychosocial disorder often precipitated or aggravated by neck~     movements or sustained neck postures. The onset and course of this pain is influenced by~     environmental and personal factors.Many studies report that participants preferred self-care~     measures for the management of neck pain and they sought professional help only when those~     measures fail~   "
50590|NCT02904655|"~     The study is a randomized, crossover meal-replacement pilot intervention to determine~     feasibility of a larger scale dietary trial in asthma and gather preliminary evidence for the~     impact of a healthy diet on asthma outcomes. Participants with doctor-diagnosed asthma were~     randomized to crossover trial of a 4-week dietary intervention or usual diet with a 4-week~     washout period. During the dietary intervention, all meals and snacks were provided by the~     study.~   "
50591|NCT02904642|"~     The overall objective is to test the impact of short message service (SMS) reminders, with or~     without unconditionally provided mobile-money incentives, can improve measles vaccination~     coverage in rural western Kenyan infants.~   "
50592|NCT02904629|"~     The objective of this research study is to evaluate a culturally tailored sexual and~     reproductive health intervention among American Indian (AI) youth. Specifically, the~     investigators aim to evaluate the impact of Respecting the Circle of Life: Mind, Body and~     Spirit on knowledge, attitude and behavioral outcomes associated with risk for unprotected~     sex, sexually transmitted infection (STI) and unintended pregnancy through a randomized~     controlled trial on the White Mountain Apache (WMA) reservation. The investigators will~     examine whether the RCL intervention effectively reduces risky sexual behavior among AI~     adolescents (11-19 years old), with long term goals of reducing teen pregnancy and~     incidence/prevalence of STIs. The evaluation will focus on well-established intermediate~     outcomes/risky sexual behaviors that predict long-term impact on teen pregnancy and STI~     incidence.~   "
50593|NCT02904616|"~     The Institut has developed a spectrofluorimeter for the registration and monitoring of skin~     autofluorescence.~      This Spectrofluorometer must be initially validated in healthy volunteers. In the long term,~     it will be used clinically to measure residual photosensitivity of patients who received a~     photosensitizer in photodynamic therapy.~   "
50594|NCT02904603|"~     Direct acting antivirals offer a new opportunity to monitor the immune response in Hepatitis~     C infection. In this study cytokine markers will be measured during therapy up to time point~     SVR 12 an correlated to clinical Parameters and regular laboratory findings.~   "
50595|NCT02904590|"~     The purpose of this study is to determine the incidence and risk factors related to Infection~     in patients with Inflammatory Bowel Disease (IBD)~   "
50596|NCT02904577|"~     Prospective collection of data of possible prognostic relevance in patients with indolent non~     - follicular B-CELL Lymphomas.~   "
50597|NCT02904564|"~     The purpose of this study is to determine whether 5-FU infusion (Microinfusion of Medicine~     Percutaneously - MMP) is effective for Idiopathic Guttate Hypomelanosis (IGH) repigmentation~     compared to conventional Microneedling. MMP is a procedure done with tattoo devices using~     medication in place of ink.~   "
50598|NCT02904551|"~     This prospective controlled randomized blind clinical study investigated 44 implants~     displaying lack of KG in 29 subjects. Fourteen subjects received FGGs followed by oral~     prophylaxis. Fifteen subjects in the control group did not receive FGGs. The width of KG,~     gingival recession (GR), pocket depths (PD), plaque index (PI) and gingival index (GI) were~     assessed at baseline, 6, 12, and 18 months. Changes in crestal bone levels, from baseline,~     were assessed at 18 months.~   "
50668|NCT02903628|"~     The purpose of this study is to determine whether Eye Health Intervention can obviously~     reduce and delay myopia onset and development and improved the awareness rate of knowledge~     apparently .~   "
50600|NCT02904525|"~     Despite maximal safe surgery followed by combined chemo-radiation therapy, the outcome of~     patients suffering from glioblastoma (GBM) remains extremely poor with a median survival of~     15 months. Hence, new avenues have to be taken to improve outcome in this devastating~     disease. Given their intracerebral localization and their highly invasive features, GBM pose~     some specific challenges for the development of adequate tumor models. Orthotopic xenograft~     models directly derived from the tumor of a patient might represent an attractive perspective~     to develop patient-specific targeted therapies. This approach remains however to be validated~     for GBM as it offers specific challenges, including the demonstration that the properties of~     xenograft models validly represent treatment relevant features of the respective human~     tumors.~      In this innovative project the investigators aim to compare and validate an approach of~     paired human GBM and respective derived orthotopic xenografts in the mouse brain on the~     levels of radiological behavior and metabolism of the tumors, as determined by high~     resolution MRI of the patients (7T MRI) and the respective orthotopic mouse xenografts (14.1T~     MRI), as well as on the level of the transcriptome, genome, and methylome of the original GBM~     tissue and respective derived xenografts/glioma sphere lines. The data will be integrated in~     multidimensional analyses and interrogated for similarities and associations with molecular~     GBM subtype.~      This pilot project will provide the basis for the crucial next steps, which will include drug~     intervention studies. New promising drugs, tested pre-clinically in the mouse orthotopic~     xenograft models established here using the radiologic/metabolic/molecular procedures~     described for this project, will be taken into patients in phase 0 studies. GBM patients will~     receive radiologic/metabolic follow-up using high resolution MRI under drug treatment,~     followed by resection of the tumor and subsequent acquisition of molecular data.~   "
50601|NCT02904512|"~     Several observational studies have shown that uncontrolled hyperglycemia in hospitalized~     patients in the non-critical care, non-Intensive Care Unit (non-ICU) setting is associated~     with prolonged length of stay, increased mortality and an increased incidence of infections.~     Randomized clinical trials in both the critical and the non-ICU settings have shown that by~     improving glucose control there is a decrease in the incidence of infections, length of stay~     and inpatient health care costs.~      Continuous glucose monitoring (CGM) systems have evolved as useful devices providing~     excellent clinical care in patients with Diabetes Mellitus (DM). These systems detect glucose~     in subcutaneous interstitial fluid using a glucose sensor that transmits glucose measurements~     to a receiving device that reads out average glucose levels every couple of minutes.~      In this clinical trial the investigators propose to examine the clinical use of CGM in~     hospitalized patients with Diabetes Mellitus type 2 (DM2). CGM use may improve glucometric~     values and clinical outcomes in hospitalized individuals with Diabetes Mellitus type 2 (DM2).~      We use CGM devices to monitor but also to transmit glucose values wirelessly to monitoring~     devices that are in the nursing station. Half of the participants are placed on Real Time CGM~     (alarms turned on) and half of them are placed on blinded CGM values (alarms turned off).~     Nursing staff will be notified when glucose is <85 mg/dl , in order to treat and potentially~     prevent a potential hypoglycemic episode.~   "
50602|NCT02904499|"~     Public health surveillance models, previously used for the ongoing detection of occurrence of~     rare events, could be used to reinforce existing pharmacovigilance systems. These models have~     not been previously used for Adverse Drug Reaction (ADR) detection in medico-administrative~     databases. DABISURV research project focuses on a new anticoagulant therapy, dabigatran,~     launched recently on the French market for atrial fibrillation (AF). This drug is at high~     risk for severe ADR and requires thus careful pharmacovigilance monitoring.~      Primary objective is to compare the results of ongoing surveillance models to detect~     hemorrhages or acute myocardial infarction (AMI) associated with dabigatran, with the results~     obtained from the analysis of a cohort of patients with AF under the same treatment.~   "
50603|NCT02904486|"~     The purpose of this study is to Effectiveness of Modified Health Belief Model Based~     Intervention to Reduce Body Mass Index for Age in Overweight Junior High School Students.~   "
50604|NCT02904473|"~     This is a pilot study to assess the feasibility, acceptability and preliminary efficacy of~     the GROWell diet intervention. The objective of this study is to determine whether the~     GROWell intervention can help transition women from consuming a Western diet to consuming a~     prudent diet (characterized by consumption of primarily fruits, vegetables, healthy fats,~     lean proteins, and whole grains) during pregnancy. Efficacy will be measured as change in~     dietary components, using a Food Frequency Questionnaire (FFQ) at baseline and at a follow up~     visit at 37 weeks gestation.~      The GROWell intervention is a mobile health technology that uses interactive text messaging~     and dietician coaching calls, and may be effective in transitioning pregnant women from a~     Western to a prudent diet during an approximately 6 month intervention period. GROWell~     results will be measured against an Attention Support Control (ASC) arm, where participants~     will receive messaging that is pregnancy rather than diet focused, and a Usual Care (USC)~     arm, where participants will not receive text messages or study coaching.~      Results from this study will be used to support a grant submission for a larger study, aiming~     to investigate the GROWell intervention and prudent diet consumption as preventatives against~     postpartum depression.~   "
50605|NCT02904460|"~     The new progresses relative to sedation-analgesia for resuscitation unit lead to perform a~     light and cooperative sedation as soon as possible in order to decrease the period of~     mechanical ventilation. Dexmedetomidine (DEX), which is a central alpha-2 agonist, is the~     referential hypnotic in this case with a reduction of the morphine-type use.~      DEX was mainly studied in the bandage procedures for the burned adult. The aim of this study~     is to evaluate the reducing effect of DEX on the morphine use in case of severe burnings for~     adults, to describe the receivers of DEX and to report the procedure of this new molecule.~   "
50606|NCT02904447|"~     The purpose of this study is to examine variabel pressure gradients of the 1st toe, 2-5th~     toes and the metatarsal distal caput in patients who have had surgery with a partial proximal~     hemiarthroplasty in the 1st metatarsalphalangeal joint (MTP) between 2006-2014.~      Also, to examine these variables and compare them to the totalt range of motion and pain, to~     find out if the measured pedobar pressure can be used identify the well treated patient and~     the poorly treated patient.~      The pedobar pressure gradients will be compared with a control group with healthy feet.~   "
50607|NCT02904434|"~     Voriconazole has better response rates, improved survival and less adverse side effects~     compared to other drugs for the treatment of invasive fungal infections making it a desirable~     therapeutic option for children. However, dosing is unpredictable in children and this leads~     to therapeutic failure. This study aims to understand the physiological differences between~     children and adults that leads to therapeutic failure of voriconazole in children.~   "
50609|NCT02904408|"~     The aim of this study is to determine the benefits of group psychotherapy on quality of life~     for people with hidradenitis suppurativa receiving medical and surgical treatment versus a~     control group (awaiting group) treated with medical and surgical treatment, without~     psychotherapy.~   "
50613|NCT02904343|"~     An important reason for the costs of hemodialysis treatment in China are expensive is the~     hemodialysis machine and related products mainly rely on imports. Hemodialysis machine is the~     basis equipment of the hemodialysis treatment. After years of research and development, China~     has had the domestic hemodialysis machine. However, due to the lack of control studies of~     domestic and imported hemodialysis machine, thus causing the domestic hemodialysis machine~     promotion has been hindered. The aim of this study is to verify the quality and safety of~     domestic hemodialysis machine.~   "
50614|NCT02904330|"~     This study is the first time that K1-70 will be administered to humans. The principal aim of~     this study is to obtain safety and tolerability data when K1-70 is administered as an IM~     injection to subjects with Graves' disease.~      Current therapy for Graves' disease includes treatment with anti-thyroid drugs, destruction~     of the thyroid using radioiodine, or total surgical thyroidectomy. Beta-blockers and calcium~     antagonists may be used to control some of the symptoms of hyperthyroidism.~      K1-70 is a thyroid stimulating hormone receptor antagonist that may provide new in vivo~     diagnostic and therapeutic tools for the management of patients with Graves' disease,~     patients with thyroid cancer and patients who would benefit from controlling receptor~     activity.~   "
50615|NCT02904317|"~     Objective: To compare the efficacy and safety of the misoprostol vaginal insert (MVI) with an~     off-label use of oral misoprostol (OM).~      Design: Pair-matched case-control study.~      Setting: Tertiary-care academic centre in Germany.~      Population: A cohort of 138 women ≥ 37/0 weeks pregnant undergoing labour induction.~      Methods: The induction of labour with a retrievable prostaglandin vaginal insert in a~     consecutive series of 69 women was compared with induction using oral misoprostol in a~     pair-matched cohort.~      Main outcome measures: The primary outcomes were the time from induction to delivery and the~     caesarean section rate. Secondary outcomes included uterine tachysystole, tocolysis, fetal~     scalp blood testing, meconium-stained amniotic fluid, umbilical arterial pH, and Apgar score.~   "
50616|NCT02904304|"~     National clinical trial, phase III, multicenter, randomized, prospective, double-blind,~     parallel, placebo-controlled, which one hundred and fifty (150) subjects of both sexes aged~     equal or more than 18 years will be randomly allocated to one the drug group or placebo~     group.~   "
50617|NCT02904291|"~     Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the~     pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the~     pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery.~     Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological~     availability of medication. In this study we investigate the pharmacokinetic effects of~     bariatric surgery on amlodipine.~   "
50618|NCT02904278|"~     The purpose of this study is to collect and compare information on how and when adolescent~     heart transplant recipients take their prescribed medication. The investigators want to find~     out if regular use of 'an app' on cell phones, called the Teen Pocket PATH® (TPP), can help~     adolescents take their medication according to their prescribed dosing schedule. This may~     then help reduce complications of transplant, such as rejection. The investigators also want~     to find out if how adolescent heart transplant recipients take their medications affects the~     development of antibodies in their blood. Antibodies are small proteins in the blood that may~     develop after heart transplantation, and which can sometimes damage a new heart.~   "
50619|NCT02904265|"~     The purpose of this study is to compare the effectiveness of the medications acetazolamide~     and diazepam in the treatment of continuous spike wave in sleep (CSWS) and Landau-Kleffner~     syndrome (LKS).~   "
50620|NCT02904252|"~     The primary objective is to assess the prevalence and genotypes of HCV infection in~     thalassemia major and thalassemia intermediate patients who have received blood transfusion~     in the Department of Medicine, Faculty of Medicine Siriraj Hospital.~      The secondary objective is to identify the effect of HCV infection as well as the risk~     factors of advanced liver disease and liver cirrhosis in these patients~      The third objective is to identify the role of serum HA level and fibrotest in the prediction~     of cirrhosis in these patients.~   "
50621|NCT02904239|"~     Modern high-end CT scanners with faster scan acquisition times now allow for routine~     assessment of cardiac pathologies, which could result in numerous incidental cardiac findings~     on standard thoracic CT angiography (CTA) scans. The CaPaCT-study aims to assesses the~     presence, management and possible clinical impact of incidental cardiac pathologies which are~     becoming visible on standard thoracic CT scans performed on new high-end scanners.~   "
50622|NCT02904226|"~     JTX-2011-101 is a Phase 1/2, open label, dose escalation and expansion clinical study of~     JTX-2011 alone or in combination with a fixed dose of nivolumab in subjects with advanced~     solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose~     (RP2D), as well as to evaluate preliminary efficacy.~   "
50623|NCT02904213|"~     An open label, non-comparative bridging study to evaluate the safety of pentavalent vaccine~     ComBe Five (Liquid) made in India, in healthy Vietnamese children aged from 8 - 10 weeks as a~     3-dose series, interval for each dose is 4 weeks~   "
50624|NCT02904200|"~     The primary objective of this investigation is to evaluate changes on Peri-Wound skin from~     baseline to termination when using two different wound dressings~      The secondary objectives are to evaluate:~      •pain before and during and after dressing removal from baseline to termination~   "
50625|NCT02904187|"~     The primary objective to this study is to describe bilateral auditory information processing~     in profoundly deaf patients with bilateral cochlear implants compared with normal hearing~     patients. Assumption used is that due to the central consequences of bilateral deafness on~     binaural auditory information central processing, time between activation of the two cochlear~     implants is a decisive factor in bilateral implantation compared to unilateral implantation~   "
50626|NCT02904174|"~     Malnutrition, risk of falls and medication incidents are commonly faced by the older adults.~     This study aimed to provide health education to community-dwelling older adults and to assess~     the effectiveness of a Healthy Living Program (HLP) to older adults in terms of fall~     prevention, drug management and healthy eating habits.~   "
50706|NCT02903134|"~     This study seeks a better understanding of the pathogenesis of asthma in early life. The aim~     of this project is to determine whether the offspring of obese mothers at 3 years of life~     have increased the risk of asthma compared to children whose mothers were not obese and~     whether this increased risk is associated with a programming altered immune reactivity at~     birth.~   "
50627|NCT02904161|"~     To address the challenges of isolating and analyzing rare cells, this study aims to validate~     technical diagnostic instrumentation, tests, protocols and analysis to correlate the number~     of circulating tumor cells present in whole blood for predicting cancer prognosis and~     treatment efficacy. Investigators propose to enroll and follow cohorts of cancer patients.~     Blood samples will be collected from these patients at regular intervals as determined by~     their doctors. The patient's disease progression will be monitored over the lifetime of this~     study. The specific aims are to isolate, enumerate and analyze the number of circulating~     tumor cells (CTCs) in patient blood using chip-based sorting, filtration and imaging~     techniques. Investigators will also use this study to optimize diagnostic instrumentation,~     test protocols and downstream CTC analysis. Investigators may also correlate the results of~     these tests with the prognosis of the patients as well as any clinical evidence (e.g. from~     radiological imaging scans). While investigators focus on prognosis in this study, these~     correlated tests potentially may also be valuable in future studies for early diagnosis and~     monitoring of cancer.~   "
50628|NCT02904148|"~     Hemiplegia is a high prevalence pathology with 1 per 1000 habitants in France. One of these~     complications is shoulder pain which affects about 35 to 70% of cases. The medical care of~     this complication is critical because it affects the patient's quality of life and also~     hinders participation in rehabilitation sessions slowing the recovery of independence in~     activities of daily living.~      Literature confirmed the involvement of the scapula in the hemiplegic shoulder pain with his~     attitude pronounced lateral rotation. But no data to confirm that passive mobilization reduce~     shoulder pain.~      Because no data available to permit us to determine the sample size we set-up this~     preliminary study to check if efficiency found in these preliminary data are consistent with~     an estimable real efficacy in a randomized trial feasible.~   "
50629|NCT02904135|"~     To address the challenges of isolating and analyzing rare cells, this study aims to validate~     the instrumentation, the test protocols, and the analysis of patient's outcome to show the~     instrument's capability to reproducibly and accurately detect CTCs in cancer patients. In~     order to facilitate the validation process, investigators will only focus on metastatic~     patients for whom CTCs supposedly present at higher abundance. Investigators propose to~     enroll cohorts of metastatic breast cancer patients. Blood samples will be collected from~     these patients before they start any new line of therapy as determined by their doctors. The~     specific aims are to isolate, enumerate and analyze the number and/or molecular information~     of circulating tumor cells in patient blood using microfluidic chip-based sorting, imaging,~     and molecular profiling techniques. Investigators will use this study to optimize diagnostic~     instrumentation, test blood processing protocols and CTC analysis algorithm. During this~     study investigators will collect patients' clinical information related to cancer, as well as~     the patients' survival status to validate the system's prognosis ability.~   "
50630|NCT02904122|"~     In this study we want to compare a dental diagnose during face to face consultation vs remote~     consultation with telemedicine device.~   "
50631|NCT02904109|"~     The purpose of this study is to investigate the effects of the eNOS activating agent~     triflusal on episodic memory and cognitive functions in participants under chronic stress.~   "
50632|NCT02904096|"~     The primary objective of this study is to evaluate the safety of Radiesse implantation for~     very severe volume loss in the dorsum of the hand at 6 months after treatment.~   "
50633|NCT02904083|"~     Bipolar disorders are common psychiatric disorders characterized by severe and recurrent~     symptomatic periods (Major Depressive Episode, mania, hypomania) and interictal periods~     characterized by persistent residual symptoms, impaired functioning and quality of life. In~     addition, the prognosis of bipolar disorder is aggravated by an increased risk of suicide and~     a high frequency of somatic comorbidities. Poor adherence is one of the major factors~     influencing the course of the disorder and one of the causes of ineffective treatments.~     Considering that between 20 and 60% of patients with bipolar disorder have problems with~     adherence. Adherence is modulated by a number of socio-demographic, clinical and~     neuropsychological factors. It is also modulated by the knowledge, beliefs and In addition,~     studies have shown that the reasons attributed to poor adherence are different depending on~     whether questioning patients or healthcare professionals. This fault diagnosis, assessment of~     the causes and fit into the reasons associated with poor adherence is an aggravating factor~     of the problem. However, this factor seems modifiable by better training of professionals. A~     team from Newcastle University in England has developed a training program for all health~     professionals to improve the diagnosis and understanding of compliance issues in bipolar~     patients and provide simple tools to fight against patients with this problem. The~     investigators assume that this training will improve medication adherence among outpatients~     by trained professionals.~   "
50634|NCT02904070|"~     Prematurity is the leading cause of mortality and perinatal morbidity. Despite the many~     preventive measures and use of tocolytic therapy, the incidence of premature births has not~     decreased in recent decades. In 2010 the preterm birth rate (single child, born alive) was~     still 5.5% in France and 11% in the population of Reunion. In 50% of cases, premature birth~     is related to spontaneous premature labor layout without rupture of amniotic membranes,~     called threat of premature birth.The threat of premature birth, defined by the combination of~     cervical modifications and regular and painful uterine contractions from 22 weeks of~     amenorrhea and 36 weeks of amenorrhea + 6days, is the major cause of hospitalization in~     pathological pregnancies services. But all threat of premature delivery situations do not~     cause premature delivery. In our service, only 30% of patients hospitalized for threat of~     premature delivery give birth prematurely in accordance with published international data.~     The diagnosis of threat of premature delivery is difficult and it is still not possible to~     differentiate a false labour of a real labour.~      Currently the diagnosis of threat of premature delivery in routine is based on the~     combination of vaginal examination, the ultrasound, cervical length, but this strategy lacks~     specificity.~      In absence of prognostic tool for predicting more reliably the risk of premature delivery in~     situation of threat of premature delivery, the medical cares are maximalist.:~     hospitalization, conducting paraclinical investigations, prescription of tocolytics~     treatments and conducting antenatal corticotherapy. it seems particularly necessary to~     identify more efficient prognostic criteria that the clinic and ultrasound for judging the~     severity of threat of premature delivery in other words to predict the risk of premature~     delivery to adapt and adjust the care of patients after diagnosis of threat of premature~     delivery.~   "
50635|NCT02904057|"~     This study will evaluate the sensitivity of the validated Merz Jawline Grading Scale (MJGS)~     to detect treatment effects following Radiesse (+) correction of subcutaneous volume loss and~     contour deficits of the jawline. Treatment effects detected on the MJGS will be correlated~     with assessments of aesthetic outcomes on the Global Aesthetic Improvement Scale (GAIS) and~     FACE-Q instrument~   "
50636|NCT02904044|"~     TsColEPS aims at identifying individual determinants of sport injuries during physical~     activity lessons in secondary school at reunion Island.~   "
50637|NCT02904031|"~     -  Few data are available about the treatment of metastatic colorectal cancer (mCRC)~          elderly patients with anti-EGFR agents in combination with chemotherapy. Up today, most~          of the available data are from retrospective/post-hoc analyses, making them difficult to~          translate to everyday clinical practice.~        -  FOLFOX plus panitumumab is a standard first-line therapy option for RAS wild-type~          untreated mCRC patients. Slight adjustments in chemo-dosage are commonly applied in~          routinary practice to elderly patients, but those modified schedules have never been~          prospectively tested.~        -  In elderly patients, a reasonable upfront treatment is a fluoropyrimidine-based~          monotherapy plus bevacizumab, irrespectively of the molecular status of RAS.~        -  BRAF mutation is a strong negative prognostic factor associated to advanced age, poor~          performance status (PS), extended and aggressive disease and is associated to a lack of~          benefit from anti-EGFR moAb.~        -  Clinical definition of elderly (over 70 years old) CRC patients that may deserve a more~          or less intensive combination therapy is still debated. The cut-off of 75 years old~          combined with ECOG PS assessment is a reasonable approach for clearly defining~          candidates to different approaches31.~        -  Several geriatric screening tools have been used to identify patients with a geriatric~          profile potentially predicting for overall survival and risk of toxicity. The G8~          screening tool has been validated in cancer patients showing the strongest prognostic~          value for overall survival; the CRASH score is able to stratify patients according an~          estimated risk of treatment-related toxicities.~      On the basis of these considerations, the investigators designed the present randomized phase~     II trial of first-line therapy panitumumab in combination with simplified FOLFOX or with~     5-fluorouracil, in previously untreated elderly patients with RAS and BRAF wild-type~     unresectable mCRC.~   "
50638|NCT02904018|"~     In this study we want to evaluate the oral care pathway after an oral teleconsultation.~   "
50639|NCT02904005|"~     This study aims at identifying predictors of suicidal behaviors in depressed subjects.~     Investigators will first compare demographic, clinical, and biological features of depressed~     recent suicide attempters (within one week) and depressed subjects without lifetime history~     of suicide attempt. Baseline risk factors for suicide will be used to predict the risk of~     attempting suicide during a one year follow-up. A thorough evaluation of these patients will~     allow to identify the factors associated with suicidal risk and develop a simplified risk~     score that could be used in clinical settings to improve our practice.~   "
50640|NCT02903992|"~     The age-associated loss of lean mass is a defining parameter of sarcopenia and may lead to~     various negative health outcomes such as impairment of physical performance and disability.~     Furthermore sarcopenia is considered to be one of the main factors in the pathogenesis of the~     frailty syndrome. However, for clinical use and for treatment and prevention strategies,~     reliable diagnostic criteria and cutpoints based on clinically relevant thresholds are~     indispensable.~      This topic has recently been addressed by the Foundation for the National Institutes of~     Health Sarcopenia Project which identified cutpoints for appendicular lean mass (ALM) below~     which older adults had a higher likelihood of clinically relevant weakness reflected by low~     grip strength. Moreover, a low ALM-to-body mass index (BMI) ratio (<0.789 men and <0.512~     women) was found to be associated with increased likelihood for mobility impairment.~      In this context, the aim of this study is to study the prevalence of sarcopenia in a sample~     of community-dwelling frail and pre-frail older adults.~   "
50641|NCT02903979|"~     In front of a lack of evidence to determine the best treatment for deep cavitated carious~     lesions, the search for an effective restorative technique, which results in a least possible~     discomfort to patients, and reduce the time needed for the restorative treatment, if becomes~     relevant. The objective of this randomized clinical trial to evaluate the efficacy of high~     viscosity glass ionomer cement restorations (HVGIC) compared to restoration with calcium~     hydroxide restoration associated with high viscosity glass ionomer cement (HVGIC) for~     treatment of deep lesions in primary molars, as well as the impact of treatment in the~     criteria focused on the patient as well as cost-efficacy of the techniques . Children with 4~     to 8 years will be selected randomly at the Clinic for Children at the University Ibirapuera~     of Dentistry. 108 teeth will be randomized into two groups: (1) restoration with calcium~     hydroxide cement associated with HVGIC and (2) HVGIC restoration. The restorations will be~     evaluated after 6, 12 and 24 months by two trained examiners blinded to the treatments. The~     efficacy of each treatment is measured by four main outcomes, which are: (1) criteria related~     to the effectiveness of the restorative treatment (2) criteria focused on the patient and (3)~     cost-efficacy. For comparison between the two groups will be used the Kaplan-Meier survival~     and the long-rank test. Cox regression is performed the assessment of the influence of some~     other variable results. For all analyzes, the significance level is set at 5%.~   "
50642|NCT02903966|"~     This study is the first experience with GSK2982772, a receptor-interacting protein-1 (RIP1)~     kinase inhibitor, in subjects with active ulcerative colitis (UC). The primary objective will~     be to investigate the safety and tolerability of repeat oral doses of GSK2982772 60 mg or~     placebo three times daily for 42 days (Part A) followed by open label with GSK298772 60 mg~     three times daily for 42 days (Part B). In addition to pharmacokinetics (PK), a number of~     experimental and clinical endpoints will be employed to obtain information on the~     pharmacodynamics (PD), and preliminary efficacy in subjects with active UC. Although no~     formal hypothesis will be tested, these endpoints will enable a broader understanding of the~     mechanism of action and potential for clinical efficacy of GSK2982772 in UC. Within 30 Days~     of screening visit, subjects will be randomized to receive either GSK2982772 60 mg or placebo~     orally three times daily for 42 Days (6 weeks) in a 2:1 ratio in Part A study. Subjects who~     complete the Part A study will move to open label Part B study to receive GSK2982772 60 mg~     three times daily for an additional 42 Days (6 weeks). After the open label (Part B)~     treatment period, subjects will enter the Follow-up period which lasts for 28 Days (+/- 3~     Days) post the last administration of study medication. The total duration of participation~     in the study will be approximately 20 Weeks from screening to the last study visit.~   "
50643|NCT02903953|"~     The very most part of clinical research in France takes place in teaching hospitals.~     Advantages to develop it in others hospitals are numerous: access to innovative treatments,~     improvement of healthcare quality, hospitals' attractiveness, increased inclusion rates and~     reduced selection bias. The objectives of the study are to report the current situation of~     clinical research outside of teaching hospitals in France.~   "
50644|NCT02903940|"~     The purpose of this study is to evaluate the application of Negative Atrioventricular~     Hysteresis (NAVH) to improve electrical synchrony in Cardiac Resynchronization Therapy (CRT)~     patients.~   "
50645|NCT02903927|"~     The main objective of the clinical study is to evaluate the performance of the CT LUCIA 601~     PY for the monocular uncorrected distance visual acuity and compare it to the reference~     monofocal IOL Acrysof IQ SN60WF.~   "
50646|NCT02903914|"~     This study is an open-label Phase 1/Phase 2 evaluation of INCB001158 as a single agent and in~     combination with immune checkpoint therapy in patients with advanced/metastatic solid tumors.~   "
50647|NCT02903901|"~     To test the efficacy of melatonin compared to placebo in preventing post-operative delirium~     and reduction in intensity or duration of delirium in individuals 65 years of age and older~     who undergo orthopedic surgery after low energy lower extremity fractures (LELEF).~      Biomarkers may play important roles in the detection, prediction and management of delirium~     especially in frail elderly individuals. Predictive biomarkers may help characterize an~     individual's susceptibility to delirium and thereby help specialized treatment, care and~     management of such individuals during their hospitalization. They may also help predict~     treatment response to a specific modality and help in selection of such modality. Recent~     studies performed in the UK and published in 2011 have measured plasma cholinesterase~     activity and determined that these levels were lower in patients who developed delirium~     compared with remaining subjects. Other studies have indicated that CRP may also have a role~     in delirium prediction as they have found that CRP measured on admission to an ICU had~     predictable changes that occurred within 24 hours that in turn were predictors of delirium.~     One the aims of the study is to compare the predictive and treatment response values of~     groups of biomarkers that have been hypothesized to be of predictive value.~   "
50648|NCT02903888|"~     A cross-sectional, observational multicenter study to assess the reasons for choosing the~     3-year hormonal IUD and level of IUDs knowledge among women aged 18 to 29 years. The study~     will be conducted in standard clinical practice conditions at public and private gynecology~     clinics and during a single study visit.~      Approximately 1,000 women aged 18 to 29 years who have freely chosen the 3 year hormonal IUD~     as their contraceptive method will be included in the study.~   "
50649|NCT02903875|"~     The therapeutic education of patients and their close relations is, as yet, poorly developed~     in France in the field of oncology, in particular for cancers of the upper aerodigestive~     tract. In the case of pharyngeal and laryngeal cancer, total laryngectomy associated with~     radiotherapy remains a reference treatment for advanced stage cancers. This mutilating~     surgical procedure has a major impact on the patient's life, due to its physical and~     functional sequelae. Its psychosocial consequences are also important, owing to the~     biographical disruption and the identity-related metamorphoses associated with illness and~     its treatment, which alter the quality of life not only of patients, but also of their close~     relations. Currently, care for laryngectomised patients consists essentially in informing and~     educating them on certain technical procedures during hospital admission. New voice education~     can be a long process and often involves the intervention of a speech therapist, who serves~     as the link between the patient and the hospital care team. These healthcare modalities often~     insufficiently account for the social, environmental and personal factors that interact in~     health-related problems.~      The aim is to design, implement and evaluate a patient therapeutic education (PTE) programme,~     for laryngectomised patients and their close relations, aimed at improving their quality of~     life.~      The research will be conducted over three phases:~      The first phase, referred to as the pilot phase, will include exploratory, observational~     and retrospective analysis aimed at developing knowledge on the consequences of laryngectomy~     on the quality of life of patients and their close relations, the strengths and weaknesses of~     current practice in patient support and the needs expressed by the players involved~     (patients, relations, professional carers). This analysis will be conducted via interviews~     with patients and their close relations and focus groups with the healthcare professionals~     involved in patient care and support (hospital and independent). This first phase will enable~     the pluridisciplinary design of a therapeutic education programme for laryngectomised~     patients and their close relations which will be tested in the study's principle coordinating~     centre. The method defined thus is in keeping with quality criteria set by the HAS specifying~     that the PTE should focus on the patient, be scientifically justified, and be developed by a~     pluridisciplinary group reuniting representatives of patients or patient associations.~      The second phase, referred to as the prospective intervention replication phase, aims at~     evaluating the programme's transferability and quality in three centres. The centres~     participating in this second phase already have experience in the development of PTE~     programmes and will be involved in the workgroup entrusted with the design of the PETAL~     programme during phase 1.~      The third phase, referred to as the randomised multicentric comparative intervention phase,~     should enable us to assess the benefits of the developed PTE programme on the quality of life~     of patients and their close relations.~      This is a pluridisciplinary study via which we hope to improve the quality of life of~     laryngectomised patients and their close relations through the design and the sustainable~     deployment of an innovative PTE programme in France and Belgium. This project also aims at~     reinforcing town-hospital links to improve help, follow-up and support for patients and their~     close relations, as well as dialogue between healthcare professionals.~   "
50650|NCT02903862|"~     The purposes of this study are to (1) track dementia caregiver health indicators over 12~     weeks, both with and without the Mindoula plus DANA intervention (case manager and mobile~     messaging and assessment applications) to determine if the intervention improves caregiver~     health and (2) obtain feedback from caregivers to inform on the design of future~     interventions.~   "
50651|NCT02903849|"~     The investigators are interested in using personalized, self-motivating messages to motivate~     people to exercise more.~   "
50652|NCT02903836|"~     Study to Determine the Safety, Tolerability, Pharmacokinetics and Efficacy of Oral~     Nafithromycin Versus Oral Moxifloxacin in the Treatment of Community-Acquired Bacterial~     Pneumonia (CABP) in Adults~   "
50653|NCT02903823|"~     The goal of this pilot study to determine whether there is a significant therapeutic~     advantage to place the ITB catheter within the cervical, thoracic or lumbar region of the~     spine. It is also a goal of this pilot study to determine whether the origin of spasticity~     influences the effect of Lioresal Intrathecal (baclofen injection) on ITB catheters located~     in the cervical, thoracic or lumbar regions of the spine. The investigators propose to study~     the impact of catheter location on the reduction in spasticity within a group of patients who~     are scheduled for ITB trial.~   "
50654|NCT02903810|"~     Clinical study of CD19 CAR-T in the treatment of blood and lymphatic system tumor has been~     achieved a breakthrough. The main solution in clinical research is to use CD19 CAR-T infusion~     alone. Because of the heterogeneity of the tumor, the patient often carries tumor cells with~     CD19 deficient but other positive target antigens (such as CD22). Specifically removal of~     CD19 positive tumor cells in CAR-T treatment, CD19 negative tumor cells or tumor cells which~     carry other target antigens would amplify with extra free space released at the same time,~     resulting in the relapse of tumors of heterogeneities. In order to effectively control the~     recurrence, CAR-T treatment scheme specific for several target antigens was presented and~     verified. However treatment with the sequential infusion of different target specific CAR-T~     cells, the window period between two times infusions may be the opportunity for the tumor~     recurrence of heterogeneity; and bispecific CAR-T has also been reported only one CAR can be~     fully functioned. In order to avoid these problems, this topic puts forward for the first~     time in the international with a treatment scheme of an equal amount of infusion of CD19-41BB~     and CD22-41BB two Car-T in the treatment of refractory hematologic malignancies. We expect~     the treatment is more effective in eliminating tumor burden, and also can inhibit the~     recurrence of tumor heterogeneity at the same time.~   "
50655|NCT02903797|"~     The purpose of the study is to determine serum irisin hormone levels an its relation between~     endometrial hyperplasia~   "
50656|NCT02903784|"~     According to the O.M.S. Classification, grade 2 glioma is a pre-cancerous lesion, slowly~     progressive, infiltrating the central nervous system, mainly affecting young adults.~      This surgery should nevertheless be conducted in awake condition to achieve two conflicting~     goals: get maximum brain tissue infiltrated by the tumor while preserving the integrity of~     functional structures. So awake after opening the skull, the patient undergoes a series of~     preoperative tests, administered by a speech therapist present in the operating room. This~     procedure allows the neurosurgeon to establish an individual functional brain mapping in real~     time, through the observation by the SLP of the patient's answers to direct electrical~     stimulation applied to the cortical and sub-cortical. This support is based on the~     extraordinary plasticity demonstrated by the brain in the presence of a slowly progressive~     lesion. To ensure the patient the highest achievable load should increase our understanding~     of brain function, including the neural bases of language, glioma grade 2 is predominantly~     localized functional area of language.~   "
50657|NCT02903771|"~     The main purpose of this study is to determine the safety and feasibility of weekly~     intra-peritoneal administration of Cantrixil to women with persistent or recurrent ovarian~     cancer, Fallopian tube cancer or primary peritoneal cancer. The study also aims to determine~     the maximum tolerated dose of Cantrixil in these patients when administered as a monotherapy~     or a combination therapy.~   "
50658|NCT02903758|"~     Malaria is still endemic in the interior of French Guiana. mixed infections by 2 or more~     different malaria parasites lead to complex and potentially harmfull therapeutic problems.~     The aim of the study was to look at malaria smears between 2000 and 2008 and determine using~     PCR the frequency of mixed infections, and their distribution in the terrtory of French~     Guiana. Overall 10.75% of 400 smears showed mixed infection with P. falciparum and P. vivax.~     The Maroni river where Duffy negative populations live was largely devoid of vivax~     infections. These results suggest that mixed infections are frequent in french guiana except~     on the Maroni river which leads to practical implications for clinicians facing a patient~     with clinical malaria.~   "
50659|NCT02903745|"~     French Guiana is the French territory where the prevalence of HIV is highest. in order to~     determine the knowledge attitudes, beliefs, and practices among the target group of teenagers~     attending the public school system a survey was conducted in 2011. schools and classrooms~     were randomly selected, and a structured questionnaire was administered. Descriptive~     statistics were obtained and multivariate logistic regression was used to determine~     predictors of main outcomes such as age at first sex.~      the results will be used to guide prevention of HIV and sexually transmitted infections~     though the school system.~   "
50660|NCT02903732|"~     The objective of the autism registry is to estimate the prevalence of autism in French Guiana~     in the cohort of children aged 8 years. Secondary objectives are to determine the prevalence~     of comorbidities, and to determine the theoretical and actual orientation of these children~     regarding care and education in a territory with significant structural deficits relative to~     mainland France. The outcomes of this registry will be to guide decision makers in their~     funding priorities to improve, screening, diagnosis, care and education for children on the~     autistic spectrum~   "
50661|NCT02903719|"~     The aim of this study is to explore whether the use of ultrasound guided phrenic nerve block~     can reduce the postoperative pain in the shoulder after liver resection. The intervention is~     directed postoperative to the patients experiencing novel right sided shoulder pain.~   "
50662|NCT02903706|"~     Malaria is the most widespread parasitic illness in the world, and it is endemic to Guiana.~     Although the number of cases has decreased since 2005, sources of infection still remain,~     particularly within illegal gold mines. These malaria carriers/sufferers often use~     self-medication to deal with malaria symptoms, resulting in a risk of resistance to~     anti-malarial treatments, and particularly to artemisinine. The mobility of this population~     across the Guiana Shield increases both the risk of malaria spreading and the resistance of~     this illness to treatment in the region, and puts the population at risk of new outbreaks of~     this disease despite the great efforts put into anti-malarial policy in this region.~      Fighting malaria within this population is therefore a dual public health challenge: on the~     one hand, make it possible for the WHO to eliminate malaria from the Guiana Shield by 2017,~     on the other to limit resistance to artemisinine in this region. However, Guiana's particular~     context - namely the illegal status of gold mines and the difficult geographical access, the~     Harpie military operations, the illegality of carrying out malarial diagnosis tests and~     treating cases without the presence of a health professional - prevents us from achieving~     this goal using the same tools as our neighbours in Suriname, whose  Looking for Gold,~     Finding Malaria  programme was a success.~      A better understanding of the malarial epidemiology in this population will enable us to~     propose innovative, more adapted measures to combat malaria within these guyanese~     populations. This is an transversal, multicentric observational study.~   "
50663|NCT02903693|"~     Given that cervical cancer is the second most frequent cancer among women in french guiana~     the aim of the study was to determine the screening rate among women living in French Guiana.~     Cervical smears are read in 2 laboratories which allowed us to compute screening rates per~     100 women-years. overall the screening activity was 23.5-25.8 smears per 100 women-years.~     between 2006 and 2011 54% of women were screened. These baseline figures will allow to~     evaluate present efforts to increase the screening rate for this frequent cancer in French~     Guiana.~   "
50664|NCT02903680|"~     Background: Headaches is one of the most common complaints of children in the ED and the~     treatment of pediatric migraine is largely based on extrapolation data from adult studies,~     limited pediatric trials, clinical experience and expert consensus. Despite the fact that~     dexamethasone has already been proven effective to reduce recurrence and is currently used in~     treating adults with migraine, no studies have looked at its use in the treatment of~     childhood migraine where relapse rate of about 50% are described in the 48h following~     successful treatment in the ED.~      Objective: To examine the effectiveness of parenteral dexamethasone at preventing migraine~     recurrence in children and to study the risk factors for migraine relapse after discharge~     from the ED.~      Methods: This a randomised, double-blind, placebo-controlled clinical trial among all~     children 8 to 17 years of age with a presumptive diagnosis of acute migraine and treated with~     a standardized protocol in the ED of the CHU Ste-Justine, a tertiary care pediatric hospital.~     After the parenteral administration of prochlorperazine or metoclopramide and~     diphenhydramine, the patients were randomised to receive either dexamethasone or a placebo.~     They were excluded from the intervention if they had a known allergy or absolute~     contraindications to receiving parenteral corticosteroids, if they were already on a~     corticosteroid regimen or if they did not respond to the initial abortive migraine therapy.~     All included patients were discharged on a 48-hour course of naproxen and with a headache~     diary to fill out and return. The primary outcome was the incidence of relapse in the 24-48h~     following discharge from ED. The secondary outcomes evaluated were the mean level of pain,~     the use of rescue medication after ED discharge, the return rate to the ED or the visit to a~     health care professional within 7 days including hospitalisation. The associated symptoms,~     the adverse events after parenteral corticosteroids and the risk factors for migraine relapse~     were also evaluated. A telephone follow-up was made to ensure the headache diary was~     completed and returned.~   "
50665|NCT02903667|"~     An open, prospective, randomized, multicenter study focused on the ridge diminution in case~     of grafting of fresh extraction sockets with Bio-Oss Collagen, Bio-Gide (Geistlich Pharma,~     Wolhusen, Switzerland), placing Dentsply implants (Astra Tech System).~   "
50666|NCT02903654|"~     Given the high incidence of Pompe's Disease in French Guiana (100 times higher than in~     mainland France) the aim is to determine the prevalence of heterozygotes among women having~     just delivered in French Guiana who accepted that their newborn child enters the depipomp1~     study. In these women the specific mutations p.Gly648Ser and p.Arg854X will be sought using~     PCR in order to calculate the prevalence of these mutations and estimate the risk factors~     associated with them in order to improve genetic counselling.~   "
50667|NCT02903641|"~     Malnutrition accounts for nearly half of child deaths worldwide. Children who are~     well-nourished are better able to learn in school, grow into more physically capable adults,~     and require less health care during childhood and adulthood. Moreover, it is difficult to~     make up for poor childhood nutrition later in life. I present here the proposal for an~     intervention that builds on a larger study in Ethiopia and will generate insights into the~     importance of behavioral factors related to persistent malnutrition in low-income settings,~     allowing for more targeted, cost-effective interventions in the future.~      Existing data from the study region, Oromia, Ethiopia, suggest that many mothers know how to~     correctly respond to a hypothetical situation where a young child exhibits poor growth. On~     the other hand, however, mothers frequently appear unaware about their own children's growth~     deficiencies. Together, these facts suggest that false beliefs about the appropriateness of a~     child's physical size are a more likely contributor to malnutrition, rather than a weak~     understanding of how to help a malnourished child.~      The proposed intervention will provide evidence on the relationship between caregiver beliefs~     about child nutritional status and the caregiver's behavior, ultimately analyzing how this~     relationship influences important nutritional choices for young children in a setting with~     limited resources. The study uses a two-by-two randomized trial; the first treatment is a~     cash transfer labeled for child food consumption, and the second is the provision of~     personalized information about the quality of the child's height compared to other children~     like those of the same age and gender in East Africa. Together the two treatment arms will~     provide evidence about the relative importance of behavioral versus resource barriers to~     improved nutrition. Better understanding of the interaction between these key factors is~     essential in addressing one of the foremost health issues facing developing countries today.~   "
50669|NCT02903615|"~     Type 1 diabetes is an autoimmune condition where circulating immune cells destroy the~     beta-cells in the pancreas that make insulin, resulting in a degree of insulin deficiency,~     whereby blood glucose levels rise and diabetes develops. When there is severe insulin~     deficiency, life-threatening ketoacidosis can develop. Treatment is lifelong insulin~     replacement therapy; dietary intervention is a also cornerstone of glucose management.~      The Optimise Diet is a multi-pronged diet based on best health principles: to minimise~     blood glucose rises after eating, reduce the immune cells involved in destruction of the~     insulin-secreting beta-cells, and improve the gut microbiome and systemic inflammation. In~     this study, its effects will be compared to the Standard Diabetes Diet that is currently~     recommended in Australia and internationally.~   "
50670|NCT02903602|"~     The purpose of this study is to determine the effectiveness of an innovative methodology for~     training Community Health Workers that will improve their effectiveness in educating mothers~     to adopt best practice health behaviors in the home.~   "
50671|NCT02903589|"~     The HIV epidemic flared from 0 to over 1% prevalence in a decade on the Maroni river which~     lies between French Guiana and Surinameaim of the study is to determine the knowledge,~     attitudes, behaviours, and practices on HIV in the population living along the French bank of~     the Maroni border. Descriptive statistics are computed from the tabulation of answers to a~     structured questionnaire. Multivariate logistic models were computed to determine predictors~     of key outcomes. These data will help taylor prevention intervention in this very particular~     area.~   "
50672|NCT02903576|"~     This study is a Phase I/II , open label,non randomized, prospective study to determine the~     safety of human embryonic stem cell derived Retinal pigmented epithelium (hESC RPE) sub~     retinal injections versus hESC RPE seeded on a polymeric substrate implanted in the sub~     retinal space,~   "
50673|NCT02903563|"~     The aim was to determine the knowledge attitudes, beliefs, and practices regarding HIV in a~     population of sex workers in French Guiana and in the Brazilian border town of Oiapoque. A~     standardized questionnaire was administered face to face to sex workers. Analysis of the~     questionnaires led to descriptive statistics. Multiple logistic regression models were~     computed to determine the predictors of condom use.~   "
50674|NCT02903550|"~     Cholesteatoma is a destructive and expanding pathologic condition consisting of keratin pearl~     arising from a squamous epithelium in the middle ear and/or mastoid process. Evolution~     consists in a destruction of the ossicles as well as their possible spread through the base~     of the skull into the brain. Surgical treatment is required to prevent infectious or~     functional complications. A recurrence after surgery occurs in approximately 10% of patients~     and rarely affects initial site. Surgical treatment is the only care option for recurrent~     cholesteatoma. Various locations such as surgical approach cavity, mastoid, hypotympanum are~     seen. Temporal bone CT is performed prior to surgery for added information on bone erosions~     especially of ossicules, tegmen tympani, facial nerve canal of internal ear. Due high~     anatomical resolution and complex anatomy, temporal bone CT is usually displayed with~     Magnetic Resonance Imaging (MRI) in operating room to help surgical guidance .~      Imaging especially using MRI is the cornerstone for diagnosis in asymptomatic patients. Since~     2006, non echo planar imaging (EPI) Diffusion weighted imaging (DWI) Magnetic resonance~     imaging (MRI) (sequences has shown high accuracy to depict recurrent cholesteatoma. If EPI~     sequences had a high rate of diffeomorphic atefacts whereas non EPI sequences using either~     HAlf-Fourier acquisition Single-shot Turbo spin-Echo (HASTE) or Fast-spin-echo demonstrates~     less magnetic susceptibility artifacts. Multimodality fusion between NonEPI-DWI-MRI and~     computerized tomography (CT) is a rational promising tool to rise the performance for~     cholesteatomas delineation. The performances of NonEPI-DWI-MRI in assessing lesion spread and~     volume are still unknown and needs further investigations. The aim of the study is to assess~     the DWI-MRI/CT fusion feasibility, reproducibility and the accuracy prior to surgery~     propectively compared to surgical findings.~   "
50675|NCT02903537|"~     The purpose of this study is to determine the safety and tolerability of the intranodal~     administration of autologous monocyte-derived dendritic cells tolerised with Vitamin-D3 and~     pulsed with myelin peptides (tolDC-VitD3) in multiple sclerosis patients . To select the most~     appropriate regime for the development of future therapeutic trials.~      To evaluate the preliminary proof of concept by clinical and/or radiological activity and~     immunological markers.~   "
50676|NCT02903524|"~     Evaluate the efficacy and safety of Doxorubicin Hydrochloride Liposome Injection Plus~     Cyclophosphamide Compared to Pirarubicin Plus Cyclophosphamide as Neoadjuvant Chemotherapy in~     Locally Advanced Breast Cancer Patients~   "
50677|NCT02903511|"~     This study is being done to determine if treatment with metformin, a drug widely used for the~     treatment of diabetes type 2, is safe and well tolerated by individuals with Autosomal~     Dominant Polycystic Kidney Disease (ADPKD) who are not diabetic and who have slightly~     decreased kidney function. The study will also evaluate the effects of metformin on kidney~     growth and kidney function.~   "
50678|NCT02903498|"~     The purpose of this study is to evaluate the efficacy and tolerability of the maintenance~     treatment of tegafur-uracil (UFT) after the standard first-line chemotherapy in advanced~     gastric cancer.~   "
50679|NCT02903485|"~     This study aims to demonstrate that presurgical assessement of patients' risk factors and~     surveillance during surgery, both performed by nurses, are not inferior to anesthetic team's~     care, concerning the rate of complications in cataract surgery with topical anesthesia.~      The nurse performs the triage of patients based on a chart of risk factors assessment. The~     triage, according to the presence or not of risk factors, leads to patients' care by an~     anesthetic team (medical anesthesist for pre-surgical assessement and anesthetic nurse for~     surveillance during surgery) or to patients' pre-surgical assessement and surveillance during~     surgery both performed only by nurses.~      In the control group, all patients are taken care of by an aesthetic team, with medical pre~     surgical assessement and surveillance during surgery both performed by anesthetic nurses.~   "
50702|NCT02903186|"~     The goals of this multi-site clinical trial are to pilot test weekly SMS sent to~     parents/caregivers of infants to improve feeding practices and decrease excessive weight gain~     in infants who are participants of the Women, Infants and Children (WIC) program in Puerto~     Rico and Hawaii. The intervention consists of weekly SMS for 4 months to reinforce the~     feeding messages provided by WIC.~   "
50703|NCT02903173|"~     The purpose of this study is to evaluate the breathing patterns of women who undergo cesarean~     delivery with spinal or epidural morphine for post-operative pain control in the first day~     after surgery. Some women who undergo cesarean delivery may be at risk for respiratory~     complications related to opiate administration for post-operative pain. The primary aim of~     this study is to evaluate post-operative minute ventilation in women who undergo cesarean~     delivery using a novel method of non-invasive minute ventilation monitoring, and to see if~     there are predictive risk factors that may predispose women to post-operative~     hypoventilation.~   "
50680|NCT02903472|"~     Changes in the GI microbiota and/or metabolomics have been linked to evolving transformations~     in immune system function and infection rates in experimental SCI in animal models. A recent~     study involving chronic survivors of SCI show distinct GI microbiome changes in comparison to~     healthy controls. GI microbial metabolism of dietary components has been causally linked to~     various health conditions, such as cardiovascular disease, infections, which is an ongoing~     concern for chronic SCI survivors. It is probable that alterations of GI microbiota are~     established acutely after SCI and could subsequently alter medical care and impact health~     outcomes for people living with SCI.~      This project is a pilot study to describe any changes in the GI and urinary tract microbiota~     as they appear over the first year after SCI. When available, data on factors, other than~     SCI, that may impact change in the gut microbiome after SCI will also be noted, including:~        -  the level and severity of SCI,~        -  the time since SCI,~        -  the person's immune profile,~        -  the antibiotic regimen of the individual and time since antibiotic administration,~        -  the incidence and type of infections after SCI and~        -  the person's diet or activities after SCI~   "
50681|NCT02903459|"~     The aim of this study is analyze the relationship between the density of visceral and~     subcutaneous fat and cellulite with the lumbar lordosis degree.~   "
50682|NCT02903446|"~     Bone erosions are a common manifestation and feature of structural damage in severe/chronic~     tophaceous gout. Management of this destructive and often debilitating gout complication has~     focused exclusively on urate-lowering therapy (ULT) to reduce frequency of gout attacks, but~     little attention has been given to prevention or reversal of gout related bone erosions and~     other structural damage to bone caused by gout. Since there is no known effective treatment~     to attenuate or improve structural damage caused by gout, we propose a pilot, controlled,~     proof-of-concept study in which denosumab, an FDA approved medication for the treatment of~     bone loss, will be added to standard ULT in 20 patients with erosive gout.~   "
50683|NCT02903433|"~     Avocados are an excellent source of fiber, potassium, magnesium, and poly- and~     mono-unsaturated fats. They can be a nutrient dense component of healthful dietary patterns~     and have the potential to improve the cardiovascular disease (CVD) risk profiles of families~     in the United States (US). The proposed research plan will focus on the contribution of~     avocado intake to the reduction in CVD risk of US families, by examining the effects of~     avocado intake on the overall nutritional status of families. Of particular interest is~     establishing these effects in ethnic populations such as Hispanics/Latinos. On average,~     Hispanic/Latinos are at increased risk for metabolic diseases that predispose to CVD. This~     6-month cluster randomized trial in Hispanic/Latino Americans aims to accurately determine~     the impact of avocados on the overall dietary pattern of their families. Future research will~     extend the results of the current trial to a larger sample of ethnically diverse families in~     order to evaluate whether sustained changes occur in nutritional, cardiovascular and~     metabolic health status.~   "
50684|NCT02903420|"~     A single arm, prospective, open, non-randomized, Japanese multicenter trial to evaluate the~     safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve System (Model:~     9600TFX) in the treatment of symptomatic severe aortic stenosis patients on chronic dialysis,~     who are determined by the heart team to be unable to undergo safe open surgical therapy and~     have the benefits of the study valve implantation.~   "
50685|NCT02903407|"~     This study aims to examine the use of protocol directed sedation using the Duke PAD protocol~     with the current sedation medications of propofol or dexmedetomidine compared to the PAD~     protocol with midazolam, per cardiac intensive care unit (CICU) usual care, as an initial~     step toward understanding the best management of sedation in these patients.~   "
50686|NCT02903394|"~     The purpose of this study is to develop a multiplexed low coherence interferometry (mLCI)~     endoscopic probe for mapping the epithelial types of the cervix. This vaginal mLCI probe will~     obtain optical measurements from the cervix. These measurements can be used to create a map~     of the surface cells that distinguishes ectocervical epithelia, endocervical epithelia, and~     the squamocolumnar junction (t-zone), which is the region where cervical dysplasia is most~     likely to occur.~   "
50687|NCT02903381|"~     This research study is evaluating a new drug called nivolumab as a possible treatment for~     smoldering multiple myeloma in order to prevent or postpone development of active multiple~     myeloma.~      - Patients with smoldering multiple myeloma do not have symptoms but are at risk for~     progressing to active multiple myeloma. Multiple myeloma is a cancer of the plasma cell,~     which is an important part of the immune system. Patients with active multiple myeloma~     generally require treatment.~   "
50688|NCT02903368|"~     This research study is studying a combination of drugs called abiraterone acetate and~     Apalutamide as a possible treatment for new diagnosed Prostate Cancer.~      The following interventions will be use in this study :~        -  Abiraterone Acetate~        -  Prednisone~        -  Apalutamide~        -  Leuprolide Acetate~   "
50689|NCT02903355|"~     This prospective study is a randomized, double-blind, placebo-controlled Phase 3 clinical~     trial of oral D-methionine (D-met) to reduce noise-induced hearing loss (NIHL) and tinnitus.~     The goal of the study is to develop a safe, oral pharmacological agent to augment physical~     hearing protectors for noise exposures that exceed the protective capabilities of ear plugs~     and/or muffs. The study population is a cohort of Drill Sergeant (DS) instructor trainees~     during and 22 days after their 11 day weapons training. The primary objective of this study~     is to determine the efficacy of D-met in preventing NIHL or reducing tinnitus secondary to a~     minimum of 500 rounds of M-16 weapons training occurring over an 11 day period.~   "
50690|NCT02903342|"~     To assess the suitability and user-friendliness of an information leaflet for parents on~     management of fever and febrile illness in children. The purpose of the leaflet is to provide~     evidence-based information for parents regarding fever and febrile illness in children.~   "
50704|NCT02903160|"~     The purpose of this study is to determine the clinical benefits of using a rapidly cycling,~     non-cross reactive regimen of FDA-approved prostate cancer therapeutic agents in the~     management of castration resistant prostate cancer. The hypothesis is that the identification~     of optimal combinations and sequencing of therapies can help prevent or delay the development~     of therapeutic drug resistance, and can be safely tolerated.~   "
50705|NCT02903147|"~     The objective of the study is to examine the effectiveness of a functional-meta-cognitive~     intervention program to reduce driving risk factors amongst professional bus drivers.~   "
50691|NCT02903329|"~     Medication-overuse headache (MOH) is a common, costly and disabling disorder affecting~     approximately 63 million people worldwide. MOH is a potentially treatable condition, and~     there are different opinions among headache specialists concerning the correct treatment~     strategy.~      The study is a prospective longitudinal open-label randomized controlled study comparing two~     detoxification programs conducted in a tertiary headache care center. Patients with MOH are~     either randomized to treatment in program A or program B. In program A, patients undergo~     detoxification without any acute medication during a two months period (complete stop of~     acute medication intake). In program B, patients was allowed to take up to 2 days a week with~     analgesics or migraine medication during the two months detoxification period (restricted~     acute medication intake). Both A and B are out-patient programs, and patients in both groups~     receive patient education, consisting of six lessons, managed by specialized headache nurses~     in collaboration with specialized psychologists and physiotherapists (Figure 1). All patients~     are also offered rescue medication (levomepromazine or promethazine) and antiemetics, if~     necessary.~      The need for prophylactic treatment is evaluated individually after 2-month detoxification.~     Patients are followed-up at 2, 6 and 12 months after detoxification. All patients are asked~     to continuously register headache calendar and to fulfill questionnaires at all the follow-up~     visits. In addition they are asked to fill out questionnaires (Headache Under-Response to~     Treatment (HURT), Hospital Anxiety and Depression Score (HADS), Severity of Dependence Score~     (SDS), World Health Organization Quality of Life Score(WHO QoL) and Dolo-score) at baseline,~     2, 6 and 12 months~   "
50692|NCT02903316|"~     The purpose of this study is to determine if extra systoles can be used to predict fluid~     responsiveness perioperatively in patients undergoing on pump coronary artery bypass graft~     (CABG) surgery. As an additional study we will investigate the ability of a mini fluid~     challenge to predict response of a larger volume of fluid.~   "
50693|NCT02903303|"~     This pilot study consists in testing the efficacy of hypnosis as an adjuvant treatment for~     patients suffering from chronic lumbar pain and for whom a facet block is indicated by a~     doctor in the Centre d'antalgie of CHUV (Centre Hospitalier Universitaire Vaudois), where~     this study will take place. 5 to 8 patients will be included in this study. The goals of this~     study are :~        -  Assess the feasibility of such a protocol with more patients~        -  Measure the number of patients necessary to obtain a significant result~        -  Search for possible side effects of the combination of both treatments~      Every patient in this pilot study will undergo 4 hypnosis sessions within 2 weeks before the~     facet block. These sessions will be done with an hypnotherapist formed for this kind of~     treatment.~      Three times during this study, each patient will have a discussion with the co-investigator~     :¨~        -  1st discussion : just before the first hypnosis session~        -  2nd discussion : after the 4 hypnosis sessions and just before the facet block,~          approximately 3 to 4 weeks after the 1st discussion~        -  3rd discussion : 2 to 4 weeks after the facet block~      They will allow to obtain several data :~        -  Pain assessment : intensity, localization, variability, characteristics, effects on~          daily life activities~        -  Anxiety and depression assessment~        -  Expectations assessment : about both treatments and their combination~        -  Efficacy assessment : about both treatments for the patient~        -  Questions about the perceptions of the treatments (prejudice, ...) et possible side~          effects.~      These data will then be analysed (quantitative and qualitative analysis, depending on the~     question type) to fulfill the objectives of the study.~      will include 5 to 8 people suffering from chronic lumbar pain. The procedure consists in two~     steps :~        1. 4 hypnosis sessions as an adjuvant treatment for number 2~        2. a facet block, which is the standard procedure in the Centre d'antalgie in CHUV.~      There will be no control group, so every patient will participate to the hypnosis sessions~     and undergo the facet block. All the procedure of the facet block (including~     contraindications and side effects) are not considered to be part of this study because all~     patients in this study would have had a facet block if they would not participate in it.~      The only data that will be collected are questionnaires about several items (pain, anxiety,~     depression, ...). These questionnaires are filled with the patient at the beginning of the~     study (day 0), before the facet block (between day 14 and day 21) and 2-4 weeks after it~     (between day 28 and day 49). There are quantitative and qualitative questions.~   "
50694|NCT02903290|"~     Genetic cerebellar ataxias involves progressive degeneration of the cerebellum. Their overall~     prevalence is estimated at 2-4 cases per 100 000 people. These diseases are manifested by a~     static and kinetic cerebellar syndrome characterized by impaired balance, coordination, and~     an ataxic gait. To date, no therapy is available for patients and physical therapy is~     essential and recommended. The evolution of the pathology causes a degradation of walking,~     increased instability and risk of falling. In one year, between 74% and 93% of patients~     reported having fallen at least once. Falls prevention by understanding the mechanisms~     affecting stability is a major issue in the management of these patients physiotherapy. The~     analysis of the literature, we assume that there exists a trio fatigue - instability -~     energy expenditure in which the three parameters would influence each other. To date, we do~     not have data to characterize these interrelationships and their evolution over time.~      STUDY OBJECTIVES: The main objective is to study the relationship between changes in energy~     expenditure and changes in instability when walking at one year in patients with cerebellar~     ataxia gene. The secondary objectives are to study, after one year of development, the~     relationship between fatigue, instability, energy consumption, the number of falls, the~     severity of ataxia and quality of life.~      CONDUCT OF THE STUDY: This is a pilot, multicenter, interventional. The projected duration of~     patient recruitment will be 12 months and the total number of patients will be included in~     15. The duration of participation in this study is 12 months for each patient. The~     anticipated duration of the study is 30 months. Development of the study: Patients included~     will perform two sets (S1 and S2) tests a year apart including the evaluation of ataxia~     according Scale for the assessment and rating of ataxia (SARA); measuring the quality of life~     through SF36 (The Short Form (36)) Questionnaire; quantifying the severity of fatigue~     perceived by FSS questionnaire quantifying the severity of physical tiredness by VAS before~     and after physical activity; quantified analysis of walking on walking track GAITRite® (with~     score calculation FAP and GVI) before and after physical activity; physical activity like~     walking on a treadmill (with measurement of maximal voluntary quadriceps by manual~     dynamometer before and after physical activity to ensure the induction of fatigue). Patients~     will be provided with a portable device for analyzing gas exchange FitMateMED® (COSMED, Rome,~     Italy) during walking analyzes GAITRite®.~   "
50695|NCT02903277|"~     The median age of onset of chronic myeloid leukemia (CML) in chronic phase PC is about 60~     years. However CML affects all age groups including 18-25 year olds, called adult-young~     adolescents (AJA). In France, there is no record of CML and especially not for this~     particular population, only a European Register of CML in children up to 18 years has been~     set up under the coordination of Professor Frederic Millot, pediatrics, CHU Poitiers.~     Malignancies diagnosed in this population usually have characteristics, evolution,~     therapeutic strategies with tyrosine kinase inhibitors (TKIs) are a real therapeutic~     revolution with an overall survival very significantly augmented but at present only a~     minority of patients may one day consider a final judgment of treatment. AJA are the most~     exposed patients to the complications, the socio-economic repercussions, professional and~     personal of a very long-term treatment. But there is little data in the literature concerning~     this population. Two studies show that diagnosis of CML presents with poor prognostic factors~     (high skoal), the observed responses are poorer compared to older patients but it is~     accompanied difference in survival in all cases with a decline of about 70 mois. However,~     these studies have focused solely on the patients included in the study receiving optimized~     treatment is not the standard treatment at the time. It is clearly demonstrated that the~     inclusion in a study brings a benefit to the patient. However, the majority of AJA are not~     included in a study. The investigators therefore want to describe the AYA population of CML~     in France and compare the evolution of patients included or not in a protocol. The~     investigators also want to investigate specific issues of the age of these patients as the~     reproductive desire. Indeed, while it does not seem to be any risk of teratogenicity for men~     treated with ITK, this risk is clearly established for women and requires specific supported.~     Another important point is that of the quality of life. The state of physical and mental~     health and his feelings, physical activity and its limitations and well-being was assessed by~     the SF-3612 questionnaire. The results of this analysis were compared with those already~     obtained for the general population (not representative of Italian adults with cancer sample)~     and adjusted for sex, age, geographic region, marital status and education level . There~     seems to be young people and women who express a feeling more pejorative. This does not only~     covers the frequency of side effects but also on physical activity and well-being. the~     affected population will be noted that that is particularly involved in the social,~     professional and in the development of his personal life. The impact of treatment on quality~     of life must be considered under penalty of seeing the difficulties of compliance. But~     several studies have demonstrated the negative impact of poor adherence in response to~     treatments .~   "
50696|NCT02903264|"~     This study evaluated the periodontal condition of gestational diabetes mellitus (GDM)~     patients and a healthy non-pregnant control group. For the GDM group all medical data were~     recorded, including obesity/insulin resistance indicators.~   "
50697|NCT02903251|"~     This study evaluates the effect of oxytocin nasal spray on alcohol withdrawal and dependence~     in adults admitted for detoxification of alcohol, and during the following 4 weeks in an~     outpatient setting. Half of the participants will receive oxytocin nasal spray, the other~     half placebo nasal spray.~   "
50698|NCT02903238|"~     This is a two week,single-blind study evaluating pain response and changes in brain imaging~     upon treatment with placebo in people with knee OA.~   "
50699|NCT02903225|"~     Controlled exercise training is a valuable therapeutic addition to pharmacological treatment~     in most patients with chronic heart failure, reducing long-term mortality, preventing cardiac~     remodeling and improving functional capacity. Despite the mechanism underlying its benefits~     might be multifactorial, a sustained improvement in autonomic balance is usually attributed~     as a major effect. Nevertheless, not all eligible subjects show the same response to~     exercise, probably due to several differences in the subpopulations enrolled. The~     investigators hypothesize that some Heart Rate Variability indexes could be valid tools to~     optimize the selection and follow-up of chronic heart failure patients to training~   "
50700|NCT02903212|"~     The aim of the study is to determine the tolerance of apoptotic autologous cells injection in~     subjects with active rheumatoid arthritis.~   "
50701|NCT02903199|"~     The current study will investigate the effect if whey protein on postprandial glycaemia and~     appetite in type II diabetics, assessing incretin (GLP-1, GIP), insulin, and appetite control~     (leptin, PYY3-36) hormone responses.~   "
50707|NCT02903121|"~     The etonogestrel (ENG) subdermal contraceptive implant (ENG implant) is a highly effective~     method of preventing pregnancy, but it has bleeding side effects that make it unappealing for~     many women. The only study to demonstrate a sustained reduction in bleeding lasting for two~     months was the selective estrogen receptor modulator (SERM) tamoxifen in users of the~     levonogestrel (LNG) contraceptive implant. Based on the investigators encouraging preliminary~     data of tamoxifen and ENG implant users, the investigators plan to perform additional studies~     on the impact of tamoxifen on the breakthrough bleeding experience by ENG implant users.~   "
50708|NCT02903108|"~     The purpose of the present study was to evaluate the effects of subgingival delivery of boric~     acid gel as an adjunct to scaling and root planing in chronic periodontitis (CP) patients.~   "
50709|NCT02903095|"~     Single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and~     pharmacodynamics of TD-1439 in healthy subjects~   "
50710|NCT02903082|"~     Sepsis remains a major cause of death in developed countries. A better understanding of the~     mechanisms involved in the regulation of inflammatory and immune response of patients with~     severe sepsis is an important step that could open the way for new therapeutic approaches.~   "
50711|NCT02903069|"~     This study is for newly diagnosed WHO Grade IV malignant glioma patients to determine whether~     an investigational drug known as marizomib (MRZ) will improve the treatment of newly~     diagnosed glioblastoma patients by delaying the growth of the cancer, reducing the size of~     the tumor, and/or improving survival. Marizomib (MRZ) is being added to standard-of-care~     treatments of radiotherapy (RT), temozolomide (TMZ), and Optune.~   "
50712|NCT02903056|"~     Introduction: Rett Syndrome is a neurodevelopmental disease that primarily affects girls.~     Clinically, patients are normal before six months to one and half years old, and then develop~     progressive severe problems with communication, learning, co-ordination and neurodevelopment,~     with loss of motor skills around the age of two. At the same time, stereotyped hand movement~     typically appears. However, some of them will improve the abilities in speech and eye gaze,~     and the repetitive hand movements may decrease after few years.~      Background / hypothesis：Preliminary evidence suggests that there are many differences in~     brain structure between Rett syndrome and normal people including cerebral volume reduction~     in both white matter and gray matter, cerebral blood flow in the frontal area, and density of~     receptors in basal ganglia. In MR imaging studies, decreases in parietal lobe gray matter~     were found, and several reductions in cortical white matter were observed by DTI. However,~     the visual related pathway- posterior corona radiata in Rett syndrome girls was normal to be~     increased in FA values. The similar result was also discovered in the superior longitudinal~     fasciculus, associated with speech, which equal to control subjects and patients with~     preserved speech (phrases and sentences).Despite this, few studies mentioned comparison with~     brain microstructure in the different stage, especially in adult patients. Therefore, our~     prospective study will be planned to figure out the specific changing pattern of brain~     structure in different stages of Rett syndrome. And the trajectory of microstructure in brain~     is going to be in accordance with the functional improvement.~      The investigators suppose that (1)there are different microstructural changes for patients~     with/without preserved mobility, verbal ability and communication skill; (2)there are a few~     specific brain microstructures changes in visual pathway; (3) there is a specific changing~     pattern of brain microstructure in different aging of Rett syndrome. To acquire more specific~     results, the investigators aim to apply conventional MRI, diffusion-spectrum imaging, and~     some clinical assessment tools like Rett syndrome -related questionnaire, SSI, PDMS-2 and~     six-minute walk test to investigate their correlation.~   "
50713|NCT02903043|"~     Limb muscle dysfunction, characterized by loss of capillaries, is amongst the most~     troublesome systemic consequences of chronic obstructive pulmonary disease (COPD) leading to~     poor functional status and premature mortality.~      One prevailing hypothesis stipulates that modification in the expression of miR-204 leads to~     change the regulation of angiogenesis in vastus lateralis of patients with COPD when compared~     to controls.~   "
50714|NCT02903030|"~     The physical and mental/emotional health of people with autism spectrum disorder (ASD) are~     closely connected. The emerging data on immune abnormalities and gut microbiome differences,~     and interactions of the genome with these suggest a possible etiological link between~     physical and mental dysfunction, especially the gastrointestinal (GI) dysfunction and severe~     anxiety that many individuals with ASD manifest. The investigators have preliminary clinical~     evidence that children with ASD & GI symptoms differ in microbiome composition and function~     from neurotypical children with GI symptoms. The investigators hypothesize that altered~     host-microbial signals, which include altered fecal neurotransmitter gamma-aminobutyric acid~     (GABA) levels contribute towards anxiety and sensory over-responsivity in ASD. Our~     preliminary findings also show that probiotic Visbiome Extra Strength, improves GI and pain~     symptoms, correlating with altered gut microbiome composition and related metabolites (the~     macrobiome). The proposed crossover trial will explore the possibilities of this new~     appreciation of the microbiome-mental/physical function connection for ASD, GI dysfunction,~     and anxiety. If altering the gut microbiome results in better GI and emotional function, it~     could improve the quality of life for children with ASD and their parents. A pilot trial with~     12 children with ASD will test feasibility for a proposed three-site crossover randomized~     clinical trial (RCT) of probiotics (beneficial bacteria including Lactobacilli &~     Bifidobacteria) in 60 children 3-12 years old with ASD, GI dysfunction, & anxiety. In a~     balanced crossover children will be randomized 1;1 to Visbiome or placebo first, 8 weeks per~     condition with 3 weeks washout between. The investigators have access to significant fecal~     microbiome and metabolome data from NIH-funded Human Microbiome Projects (HMP) on similar-age~     healthy and irritable-bowel children, with and without ASD. These will help leverage our~     understanding of macrobiome changes that correlate with functional improvement of GI and~     abdominal pain symptoms. Pilot study efficiency will also benefit from those HMPs having~     already collected and analyzed baseline stools for some children with ASD, thus saving~     significant costs for baseline stool analyses for the pilot.~   "
50715|NCT02903017|"~     Upper gastrointestinal hemorrhage is a frequently diagnosis in emergency departments.~     Although new drugs and endoscopic techniques were easily applied in various settings in this~     condition, the role of local administered therapies such as antifibrinolytic agents remain~     unclear. The investigators aimed to compare standard therapy (proton pump inhibitors,~     endoscopic treatments etc.) and standard therapy + local administered tranexamic acid in~     upper gastrointestinal hemorrhage in a double-blind, randomized trial.~   "
50716|NCT02903004|"~     This is an open-label, prospective, multicenter, randomized Phase III, clinical trial~     evaluating the efficacy and safety of trabectedin in BRCA1 and BRCA2 mutation carrier and~     BRCAness phenotype advanced ovarian cancer patients in comparison to physician' choice~     chemotherapy.~      Arm A: Trabectedin 1.3 mg/mq d1 q 21 in 3 hours (central line) Arm B: Pegylated Liposomal~     Doxorubicin 40 mg/mq q 28 or Topotecan 4 mg/mq dd 1,8,15 q 28 or Gemcitabine 1000 mg/mq dd 1,~     8, 15 q 28 Weekly Paclitaxel 80 mg/mq gg 1, 8, 15 q 28 Carboplatin AUC 5-6 q 21 or 28~      Patients will be randomly assigned in a 1:1 ratio to treatment arms. During the randomization~     process, patients will be stratified by~        -  Platinum sensitivity~        -  Measurable disease~        -  Number of previous chemotherapy lines > vs < 3~        -  BRCA mutational status~   "
50717|NCT02902991|"~     Through this prospective clinical trial,the investigators will focus on the relationship~     between circulating tumor biomarkers (i.e. circulating tumor cells, circulating tumor DNA and~     other biomarkers) and the status of primary tumor to discuss its application for assessing~     prognosis and individualized therapeutic direction. Moreover, the relationship between the~     circulating tumor cell subpopulations based on epithelial-mesenchymal transition and~     molecular pathological classification of breast cancer will be determined, which may enable~     the determination of the value of its application in therapeutic decision making.~   "
50720|NCT02902952|"~     Anxiety is one of the most frequent comorbidities in children with ASD leading to poor~     clinical outcomes. Physical exercise has been shown to be a promising and easy to implement~     intervention for reducing anxiety. However, little is known about the feasibility and~     efficacy of physical exercise to reduce anxiety in children with ASD from underserved,~     low-income families. Children with ASD, ages 6 - 12 years old from low-income and Latino~     families will be recruited for the study and assigned to an exercise intervention group and a~     sedentary control group. The physical exercise program is an eight-week program, administered~     three times per week in small groups. Compliance, parent-rated anxiety, and salivary cortisol~     will be measured before and after completion of the exercise and control group interventions.~   "
50721|NCT02902939|"~     Pro- and anti-inflammatory response during the formation of the critical state develops at~     the same time. Because of its balanced or unbalanced systemic inflammation can be either~     aborted or able to lead to multiple organ failure. With regard to sepsis, systemic~     inflammatory response characteristics are well understood, is not achieved in respect of the~     sterile inflammation.~      Extracorporeal circulation is a clinical model of systemic inflammatory response due to~     non-physiological activation of tissue factor in the extracorporeal perfusion, the use of~     non-pulsatile circulation mode, intentional / unintentional hypothermia, bacterial~     translocation from the gastrointestinal tract and perfusion deficit.~      We have proved that the monocytes demonstrate suppressor function, which can be a predictor~     of complications from cardiac surgery patients.~      The most important component of the formation of multiple organ failure (MOF) in critically~     ill patients is immunosuppression.~      During the study of experimental and clinical tumor growth process scientists has provided a~     new population of immature myeloid cells (myeloid suppressor cells or suppressor cells of~     myeloid origin, MDSC). Most of the works have been devoted to the role of MDSC in the~     development of tumors, where it has been clearly shown that this cell population has an~     undoubted effect of immune suppression. However, recent studies show that the role of MDSC is~     not limited to cancer process, but extends to chronic or acute inflammation.~      The aim of this study is to determine the role of MDSC in the development of immune~     suppression and complications after heart surgery carried out under cardiopulmonary bypass.~   "
50722|NCT02902926|"~     IBS is a global disease, patients often because of long-term symptoms of recurrent, not~     timely diagnosis and treatment effect is not ideal and frequent treatment, seriously affect~     the quality of life, and cause the corresponding economic and social burden.At present，a~     number of studies suggest that fermentable oligosaccharides, disaccharides and~     monosaccharides and polyols (FODMAPs) can induce IBS symptoms.Data from large randomized~     controlled trials are limited, leaving clinicians with the challenge of providing patients~     with reliable guidance based on minimal evidence.~   "
50723|NCT02902913|"~     Data from limited dietary intervention trials suggest that the cardiovascular health benefit~     of extra virgin olive oil (EVOO) may increase with phenolic content. However, while EVOOs~     contain an array of bioactive compounds, little information exists regarding the~     physiological effects of specific chemical species. Among the EVOO-derived phenolics with~     demonstrated anti-inflammatory effects in animal and in vitro models is oleocanthal, an~     inhibitor of cyclooxygenase (COX). The current study compared the impact of acute intake (40~     mL) of EVOO on platelet reactivity in healthy adult males (n=9). The volunteers were randomly~     assigned to consume three EVOOs in a double-blind controlled trial. The EVOO were~     characterized and chosen for equivalency in their total phenolic content and fatty acid~     profiles, but differing in their oleocanthal to oleacein ratio.~   "
50724|NCT02902900|"~     This study, a national, multicenter, observational, ambispective, non-interventional study,~     will be conducted in French hospitals prescribing pomalidomide and already participating in~     the ongoing Imnovid registry.~      This study will add to the registry. Indeed, pomalidomide-prescribing physicians and~     pharmacists dispensing pomalidomide have to enter into the Imnovid registry all patients who~     have been prescribed this drug since the date on which it was marketed regardless of the~     initiation date of pomalidomide or the indication for which it was prescribed.~   "
50725|NCT02902887|"~     This study presents an opportunity to understand a novel, previously unreported controlled~     intermittent alternate occlusion (CIAO) therapy glasses, which may improve the control of~     Intermittent exotropia (IXT).~   "
50726|NCT02902874|"~     To study the correlation between the polymorphism of the main immunity genes and~     progression-free survival in ALCL of the child.~   "
50727|NCT02902861|"~     This is a multicenter, multinational (12 centers planned, in Germany 9 centers and in France,~     the Netherlands and the United Kingdom (UK) 1 center in each country respectively),~     randomized, double-blinded, placebo-controlled study. The primary objective is to evaluate~     the efficacy of methotrexate (MTX) in patients with moderate to severe Psoriasis compared to~     Placebo as assessed by the primary endpoint 75% reduction of Psoriasis Area Severity Index~     (PASI 75 ) during a 16 week treatment phase. As secondary objectives the safety and efficacy~     of the optimized treatment schedule will be assessed using multiple methods (e.g. (Serious)~     Adverse Events ((S)AE) occurrence and questionnaires)~   "
50728|NCT02902848|"~     The purpose of this study is to evaluate the INR value of hemodialyzed patient coagulation~     state (prothrombin time) measured inside the therapeutical zone and thanks to a portable~     monitor. The values obtained at the point of care will be compared to the standard biological~     assessment.~   "
50729|NCT02902835|"~     The goal of this study is to test whether peer mentors (i.e., individuals with past opioid~     addiction and prior incarceration) can facilitate entrance into buprenorphine (Suboxone)~     treatment for individuals with opioid use disorder who were recently released from jail or~     prison. In order to test whether it is helpful to have peer mentors paired with recently~     released individuals, the investigators will conduct an 18 month study, recruiting 72~     formerly incarcerated individuals and assigning them by chance selection (like flipping a~     coin) to either a group that will receive peer mentorship or a group that will receive a~     referral to a community clinic.~   "
50730|NCT02902822|"~     The purpose of this study is to demonstrate the validity and utility of a tele-dermatology~     system in the midterm periodic screening of non-widespread skin lesions of recent onset or~     for which a specialized early classification is deemed to change the prognosis - including~     precancerous skin lesions as well as melanoma and non-melanoma skin cancers - compared to~     control visits at fixed follow-up.~   "
50732|NCT02902796|"~     A randomized controlled with cross over study compares efficacy of burst stimulation, 1000~     hertz stimulation, and standard stimulation in an non-superiority trial. The study duration~     is approximately 24 weeks and each stimulation modes will last for approximately 3 weeks with~     approximately 4 days of wash off in between.~   "
50733|NCT02902783|"~     The DONATE-Pilot is a prospective observational cohort study in organ donation (OD) that~     observes the ICU management of consented deceased organ donors at 4 high volume centres over~     a period of 12 months each. The pilot study will be followed by a 1-year prospective national~     observational study a 15-20 ICUs across Canada.~   "
50734|NCT02902770|"~     The literature regarding analgesic modalities, their combinations and routes of~     administrations for patients with pain related to renal colic is expanding. NSAID's (IV~     ketorolac) and opioids (morphine) constitutes the mainstay of treatment of renal colic either~     alone or in combinations. Despite their synergism and analgesic superiority when administered~     together, both classes of these medications possess a set of unfavorable side effects that~     limit their use. Emerging data of the use of IV lidocaine for patients with renal colic~     demonstrated good analgesic efficacy and safety profile. However, none of the trials directly~     compared lidocaine to ketorolac or the combination of both as viable options in patients~     unable to tolerate or to have serious contraindications to opioids. We designed a~     double-blinded, randomized, controlled trial to evaluate analgesic efficacy, safety and~     feasibility of non-opioid analgesics and their combinations in patients with renal colic. The~     hypothesis and proposed study will try to determine if a combination of IV lidocaine and~     reduced dose of IV ketorolac is superior to either drug alone and if this non-opioid~     analgesic modality is effective for controlling pain of renal colic origin.~   "
50735|NCT02902757|"~     This pilot clinical trial studies fluordeoxyglucose (fludeoxyglucose) F-18 (FDG) positron~     emission tomography (PET)/computed tomography (CT) in monitoring very early therapy response~     in patients with glioblastoma. Diagnostic procedures, such as FDG PET/CT, may help measure a~     patient's response to earlier treatment. Chemotherapy can induce very rapid changes to the~     tumor's glucose consumption which can be measured with imaging. FDG PET/CT shortly after the~     start of therapy may help identify very early therapy response in patients with glioblastoma.~   "
50736|NCT02902744|"~     Primary Objective:~      • To collect post-approval safety data related to intraocular pressure (IOP) after one or~     more injections of Iluvien as standard of care in subjects with diabetic macular edema (DME).~      Secondary Objectives:~      • To collect visual and anatomic outcome data after one or more injections of Iluvien as~     standard of care in subjects with diabetic macular edema (DME).~   "
50737|NCT02902731|"~     SYNOPSIS The giant cell arteritis (GCA) is the most frequent vasculitis in people over 50~     years. Despite recent progress and physiopathogenic, corticosteroids remains the standard~     treatment for decades with a very good initial clinical efficacy but a high relapse rate~     (nearly 40% to 6,5 months) during its decay. This sensible population is particularly exposed~     to the side effects of corticosteroids, leading to think about savings strategies. But the~     association of immunosuppressive therapy and/or anti- TNFα has not demonstrated benefits in~     terms of efficiency or long-term tolerance to cumulative doses of prednisone. The~     responsibility of proinflammatory cytokines such as TNFα, IL- 6 and IL-1 has been studied in~     the pathogenesis of GCA in temporal artery walls and in mouse models. The primary pathogenic~     role of IL- 1 is based on the increase in serum or nuclear protein itself or that of its~     mRNA. The study of temporal artery biopsies has shown increased local production of IL- 1β~     mRNA, IL- 6 and TGFβ (indicative of macrophage activation ) and those of INFɣ and IL 2~     (indicative of T lymphocyte activation). Recently, Ly et al (Ly KH JBS 2014) reported the~     efficacy of anakinra, a recombinant molecule of IL- 1RA specifically blocking the IL- 1 α/β,~     in three cases GCA refractory to conventional treatments.~      Here investigators propose a randomized, multicenter, controlled, double-blind study of~     anakinra against placebo in addition to corticosteroids in the treatment of GCA.~      This study will include 70 patients randomized equally in both arms: reference treatment~     (prednisone plus placebo) or the experimental treatment (prednisone + anakinra). Treatment~     with prednisone will be identical in the two arms, namely a dose of 0.7 mg/kg/day orally on~     day 1, followed by a progressive decrease in the dose pattern depending on the weight. In the~     experimental arm, dose of anakinra is the one usually used, ie 100 mg/day by subcutaneous~     injection from day 1 until the end of week 16 (S16). In the reference arm of the treatment, a~     placebo anakinra is associated with corticosteroid in the same packaging, duration and~     respecting the double-blind.~      Investigators thus hypothesized that the addition of anakinra to corticosteroid compared to~     placebo added to the latter, will show a significant decrease in GAC relapse rate. Indeed,~     the challenge of corticosteroid therapy in this disease is not so much a problem of initial~     effectiveness, than the adverse events related to relapses and steroid dependence.~   "
50738|NCT02902718|"~     The purpose of this pilot study is to evaluate the feasibility of the Mē device for at home~     facial skin rejuvenation.~   "
50739|NCT02902705|"~     Many metabolic disturbances, such as protein-energy wasting, inulin resistance, and~     dyslipidemia are common features of chronic kidney disease (CKD). However, to date, the~     underlying mechanisms of these disturbances remain elusive. Many in vitro studies have~     demonstrated that white adipose cells exhibit dysfunctions in conditions that mimics uremic~     environment. In good agreement, several animal experiments have reported that chronic kidney~     disease was associated with lipoatrophy, adipose tissue dysfunction and ectopic lipid~     redistribution. The goal of this protocol is to collect and study structural and metabolic~     properties of white adipose tissue in CKD stage V patients to evidence adipose tissue~     dysfunction associated with CKD. The primary outcome measure will be the cellularity of the~     adipose tissue (i.e. size of the adipose cells) and the secondary measure to study the gene~     expression profile using microarray and metabolic properties of adipose tissue (i.e.~     lipogenesis). To this end, 15 male adult volunteers and 15 non-diabetic and non-dialyzed CKD~     stage V patients, matched for age, gender and body mass index (BMI) will be recruited at the~     Departments of Nephrology or Urology of Lyon University Hospital (Lyon, France). The biopsies~     of abdominal subcutaneous white adipose tissue (2-3 g) will be performed during elective~     urologic surgery (i.e. peritoneal dialysis catheter for CKD patients and radical~     prostatectomy for non CKD patients).~   "
50740|NCT02902692|"~     The current study will examine the effects of a brief mindfulness based intervention (BMBI)~     on mood, memory and attention in comparison to a wait-list control (WLC) group. Participants~     for the study will be 90 adults aged 50 years and above who have presented at a memory clinic~     within SLaM NHS Trust with subjective cognitive concerns and/or those who have received a~     diagnosis of mild cognitive impairment (MCI) from their memory clinic.~   "
50741|NCT02902679|"~     An oral dose of BMS-986177 administered in End-stage Renal Dysfunction (ESRD) participants~     before and after a hemodialysis session to evaluate safety, tolerability, and~     pharmacokinetics in this patient population.~   "
50808|NCT02901808|"~     The registry includes patients undergoing cardiovascular and thoracic surgery at the Saarland~     University Medical Center, Homburg/Saar, Germany. This study is a monocentric, retrospective~     study investigating the development of NOMI and outcome of patients.~   "
50742|NCT02902666|"~     The purpose of this study is to evaluate the bioequivalence of a new paracetamol 1000~     mg/codeine 30 mg formulation vs. the marketed reference Co-efferalgan® 500 mg/30 mg in terms~     of rate and extent of absorption, when administered as single oral dose (one tablet of the~     new A.C.R.A.F. formulation vs. two tablets of the reference formulation Co-efferalgan®) to~     healthy male and female volunteers, under fasting conditions, in two consecutive study~     periods.~   "
50743|NCT02902653|"~     This study evaluates the efficacy and safety of the administration of oral misoprostol versus~     vaginal dinoprostone and vaginal misoprostol for cervical ripening and labor induction.~   "
50744|NCT02902640|"~     This is a pilot, observational and multicentric study of safety of sulfamethoxazole +~     trimethoprim + guaifenesin (Balsamic Bactrim) in adult participants with acute bronchitis.~     Adult participants with acute bronchitis eligible for treatment with Balsamic Bactrim will be~     enrolled. Administration of Balsamic Bactrim will be according to physician's recommendation~     under local labeling.~   "
50745|NCT02902627|"~     l'ANI (Analgesia Nociception Index~      The main objective of the research is to estimate the Analgesia Nociception Index (ANI) as a~     parameter giving the possibility of measuring the pain in painful metastatic cancer. The~     parameter ANI is compared with visual analogical scale (VAS) score.~   "
50746|NCT02902614|"~     Selection of side of embryo biopsy that will not interfering with implantation power of~     developed blastocyst embryo during biopsy procedure arranged for PGT.~   "
50747|NCT02902601|"~     The primary purpose of this study is to investigate the safety and tolerability of JNJ~     54175446 in participants with Major Depressive Disorder (MDD).~   "
50748|NCT02902588|"~     The purpose of the study is to confirm the applicability and usefulness of the novel method~     of assessment of the permeability of the blood-brain barrier and in monitoring of the~     treatment of patients with meningitis. The proposed technique is based on evaluation of the~     kinetics of the indocyanine green (ICG) outflow from the brain with the use of near-infrared~     spectroscopy (NIRS). Usefulness of the NIRS-based method will be analyzed in relation to the~     reference method, which is contrast-enhanced magnetic resonance imaging (MRI).~   "
50749|NCT02902575|"~     The purpose of this study is to explore the safety, feasibility, long-term and~     oncologicaloutcomes of laparoscopic-assisted gastrectomy for advanced Gastric Cancer after~     neoadjuvant chemotherapy.~   "
50750|NCT02902562|"~     This study is about using contrast-enhanced ultrasound (CEUS) to assess the degree of~     synovitis (joint inflammation) in patients with inflammatory arthritis, such as rheumatoid~     arthritis, and whether it can be used for assessing a treatment response. The investigators~     hope to learn whether contrast enhanced ultrasounds are better than regular imaging~     techniques, such as MRI, when used to evaluate the response to disease modifying~     anti-rheumatic drug (DMARD) therapy in inflammatory arthritis.~   "
50751|NCT02902549|"~     Surgeons are nowadays unable to visualize and quantitatively evaluate microvascularisation in~     real-time during surgery. Complications due to vascular compromise are a major problem,~     especially in reconstructive surgery. Poor blood perfusion leads to ischemia and even tissue~     necrosis. If, however, perfusion and ischemia could be monitored during surgery, then~     surgeons could change their reconstructive design and the anaesthesiologists could improve~     perfusion with fluids, inotropes or vasopressors, if necessary. Surgeons therefore need a~     tool that is able to image in high resolution (microvascularisation), direct,~     intra-operative, in 3D (to image thrombosis, luminal narrowing or distinct overlaying~     vessels) and that produces quantitative data to objectify image interpretation.~      Optical techniques, based on the interaction of light with tissue, are able to image tissue~     at high resolution and in real-time. These techniques are FDA-approved and have emerged as~     powerful diagnostic tools in different departments of medicine, such as ophthalmology for~     visualizing retina vascularisation and dermatology for skin diagnostics.~      In this study, investigators hypothesize that four novel optical technologies: Fluorescence~     Imaging, Laser Speckle Contrast Imaging, Optical Coherence Tomography and Sidestream~     Darkfield Microscopy are able to quantitatively image perfusion in real-time during surgery.~   "
50752|NCT02902536|"~     This is a study during which the investigators collect plasma and cells from patients with~     myasthenia gravis for the purpose of finding new antibodies.~   "
50753|NCT02902523|"~     A randomized, open-label, single-dosing, 2x2 crossover study to compare the safety and~     pharmacokinetics of HUG116 tablet(Tenofovir Disoproxil) with Viread® tablet(Tenofovir~     Disoproxil Fumarate) in healthy male volunteers~   "
50754|NCT02902510|"~     This is a single blind, randomized, wait-list controlled, phase II exploratory pilot study.~   "
50755|NCT02902497|"~     The goal of this study was to evaluate, in the hands of an inexperienced surgeon, the~     cochleostomy location of an endaural approach (MINV) compared to the conventional posterior~     tympanotomy (MPT) approach. Since 2010, the investigators use in the ENT department of Nice a~     new surgical endaural approach to perform cochlear implantation. In the hands of an~     inexperienced surgeon, the position of the cochleostomy has not yet been studied in detail~     for this technique. This is a prospective study of 24 human heads. Straight electrode arrays~     were implanted by an inexperienced surgeon: on one side using MPT and on the other side using~     MINV.~   "
50756|NCT02902484|"~     The study will perform a clinical study evaluating the safety and tolerability of nintedanib~     when combined with standard chemotherapy (Gemcitabine + nab-Paclitaxel) for metastatic~     pancreatic cancer. It will utilize advanced imaging correlates including dynamic contrast~     enhanced Magnetic Resonance Imaging (DCE-MRI) which correlates with tumor grade and~     microvessel density.~   "
50757|NCT02902471|"~     A study to evaluate the role of forced oscillations in diagnosis of bronchiolitis obliterans~     syndrome in patients after bone marrow transplantation. The force oscillations technique will~     be compared with classical spirometry.~   "
50758|NCT02902458|"~     This study aims to investigate whether follow-up with a psychologist has an impact on the~     outcome of patients with an implantable automated defibrillator.~   "
50759|NCT02902445|"~     The GASTROVIM research explores the links between individual genetic susceptibility, genetic~     variability of rotavirus strains and effectiveness of immunization with the rotavirus~     vaccination: a clinical investigation to assess glycan attachment specificity, toward~     rotavirus vaccine improvement.~   "
50879|NCT02900885|"~     Retrospective medical chart and medical imaging file review of patients suffering from palsy~     of the superior rectus extraocular muscle~   "
50760|NCT02902432|"~     The purpose of this study is to evaluate the efficacy and safety of recombinant human~     endostatin（continuously-pumped）combined with chemoradiotherapy in patients with advanced~     squamous cell carcinoma of the head and neck. The patients will be randomized to concurrent~     radiotherapy (CRT) arm and CRT + Endostar arm. All patients will receive one cycles of~     induction chemotherapy, intensity modulated radiation therapy (IMRT) with weekly cisplatin~     and 3 cycles of chemotherapy after IMRT. Treatment cycles will be repeated every 21 days for~     a maximum of 4 cycles. In CRT + Endostar arm, Endostar will be continuously intravenous~     pumped (7.5 mg/m2) for 14 days (d1-d14) during chemotherapy and for 5 days/week (d-5-d-1,~     d3-d7, d10-d14, d17-d21) during IMRT.~   "
50761|NCT02902419|"~     A randomized controlled trial measuring surgical site infection rate as a function of timing~     of wound dressing removal.~   "
50762|NCT02902406|"~     This is a follow up study which aims to evaluate the correlation between several methylated~     genes (potential biomarkers) and oral cancers. A prospective case control trial is designed~     with sample size of at least 300 cases with estimated 200 subjects with precancerous lesion~     or oral cancer, and 100 subjects with normal oral mucosa. This study is approved by the~     National Taiwan University Hospital Research Ethics Committee. After signing the informed~     consent, all subjects will receive an intraoral examination and followed by epithelial cells~     collection with oral swab. The gDNA will be extracted from the oral swab collected cells and~     followed by bisulfite conversion procedures. Subsequently, bisulfite converted DNA will be~     subjected to methylated gene detection by Real-Time PCR. The methylation index (clinical~     sensitivity and specificity) of oral cancer related genes will be evaluated. For diagnosis~     confirmation, photos and biopsy specimens will be taken upon observation of abnormal lesion.~   "
50763|NCT02902393|"~     Revascularisation using recombinant tPA is the reference treatment of stroke. However, the~     efficacy of fibrinolysis is about 50%. Several factors, including the size of thrombus, have~     been associated with revascularisation efficacy.~      The aim of this prospective study is to evaluate ex vivo the effect of tPA in patients with~     stroke with thromboelastography and to correlate results with the clinical outcome of~     patients. Results may predict revascularisation in patients with stroke.~   "
50764|NCT02902380|"~     Surgical stress induces stress hormone release and sympathetic hyperactivation.~     Dexmedetomidine has sympatholytic effect and attenuates stress responses. This study~     investigate the effect of dexmedetomidine on stress responses and autonomic nervous system~     balance in patients undergoing major spine surgery.~   "
50765|NCT02902367|"~     Eighty community-living individuals in Uppsala municipality will be included. Intervention:~     Outdoor walking exercise program and one strength exercise. Methods: Clinical assessments,~     questionnaires and medical records. Assessment of motor function, cognition, level of~     physical activity, food intake and perceived stress are performed at screening as baseline~     measurements. Walking capacity, mobility, handgrip strength, body composition and~     cardiovascular risk markers will be assessed at baseline and after 12 week of training. At~     one year after training health-related quality of life, another cardiovascular incidence and~     mortality will be documented.~   "
50766|NCT02902354|"~     To determine the central blood pressure changes in normotensive women who are receiving~     nifedipine for uterine contraction suppression~   "
50767|NCT02902341|"~     Background: Malnutrition is widespread among cardiac surgery patients and is independently~     related to an adverse postoperative evolution or outcome. The investigators aimed to assess~     whether nutrition therapy (NT) could alter caloric deficit, morbidity, and mortality in~     patients scheduled for non-emergency coronary artery bypass graft (CABG) or aortic valve~     surgery.~      Methods: 351 patients undergoing either elective CABG or aortic valve surgery were studied.~     Patients receiving NT were enrolled from January 2013 until December 2014. A historical~     control group consisted of 142 matched patients. Preoperative nutritional status was~     evaluated. Resting energy expenditure was measured using indirect calorimetry or calculated.~     Caloric intake and caloric deficits were assessed. The primary endpoint was to evaluate~     whether NT could limit caloric deficit (Intake to Need Deviation). A secondary endpoint~     addressed the potential effect of NT on morbidity and mortality. Patients were followed for~     one year after surgery.~   "
50768|NCT02902328|"~     SIS has developed a software technology, based on machine learning and image processing,~     designed to enhance standard clinical images for the visualization of anatomical structures.~   "
50769|NCT02902315|"~     Acutely resistance exercise induces inflammatory responses and leukocytosis arising of~     oxidative stress, that clinically manifested by pain and/or delayed onset muscle soreness~     (DOMS). Beginners in resistance exercise programs are more vulnerable to the effects of~     oxidative stress as they exhibit lower antioxidant capacity, greater lipid peroxidation and~     present increased perception of pain after exercises that may lead to abandonment the~     exercises practice. Vitamins C and E are exogenous antioxidants which are able to prevent~     damages caused by oxidative stress. Cryotherapy decreases temperature and reduced generation~     of reactive oxygen species. The aim of the present research are to investigate the effects of~     the concomitant of vitamins and of cryotherapy on leukocytosis, inflammatory markers,~     oxidative stress parameters and pain in untrained individuals submitted to a resistance~     exercise session.~   "
50770|NCT02902302|"~     The main objective of the study is to evaluate the bioequivalence of a new formulation of~     ibuprofen 400 mg/10 mL oral suspension vs. the marketed reference product MOMENTACT 400 mg~     film-coated tablet, when administered under fasting conditions as single oral dose to healthy~     male and female volunteers, in two consecutive study periods.~   "
50771|NCT02902289|"~     The main objective of the study is to evaluate the bioequivalence of a new formulation of~     ibuprofen 200 mg/5 mL oral suspension vs. the marketed reference product MOMENT 200 mg coated~     tablet, when administered under fasting conditions as single oral dose to healthy male and~     female volunteers, in two consecutive study periods.~   "
50784|NCT02902120|"~     The purpose of this study is to determine whether patients treated for chronic hepatitis C~     (HCV) with zepatier (grazoprevir/elbasvir) prior to kidney transplant will have a stronger~     immune response compared to patients treated after kidney transplant. 25 patients with~     chronic kidney disease (CKD) and HCV will be treated with zepatier and 25 kidney transplant~     recipients with chronic kidney disease will be treated with zepatier. Blood markers of immune~     function will be monitored in both groups to determine their response to therapy.~   "
50772|NCT02902276|"~     In critically ill patients, the small bowel permeability is increased, leading to bacterial~     translocation, and systemic inflammatory response syndrome.~      Plasma citrulline is a validated biomarker of functional enterocyte mass. Lipopolysaccharide~     (LPS) is a part of Gram negative bacteria, and plasma LPS concentration is a biomarker of~     bacterial translocation. The link between plasma citrulline and LPS in the critically ill is~     unknown. Investigators hypothesize that patients presenting with low plasma citrulline~     concentration, with presumed altered small bowel function, would have an increased phenomenon~     of bacterial translocation, and increased plasma LPS concentration. Investigators aimed to~     evaluate the link between plasma citrulline and LPS concentrations in critically ill patients~     at the time of ICU admission.~   "
50773|NCT02902263|"~     Early thrombolysis is essential in treating ischemic strokes. The time window for~     thrombolysis is limited to 4,5 hours after symptoms onset.~      In the French region of Franche Comté, in order to reduce the thrombolytic delay, a~     telemedicine network was developed between the neurovascular reference unit (NVU) localised~     in the University Hospital of Besançon and the peripheral hospital centres. Patients may then~     be transported to the NVU immediately after the thrombolysis initiation.~      The aim of our study was to assess the relevance of a systematic medicalization of transfer~     to the NVU of patients with stroke who were telethrombolyzed before.~      It was a retrospective, monocentric and observational study conducted over 24 months, in~     Franche-Comte (France).~   "
50774|NCT02902250|"~     The purpose of this study is to compare the treatment efficacy between vertebral body~     decompression procedure and vertebroplasty with non-inferiority design~   "
50775|NCT02902237|"~     In this phase I clinical trial cancer patients suffering from solid tumors or lymphomas,~     recurring after and/or refractory against standard treatment are treated intravenously (iv)~     with increasing doses of tTF-NGR(tTF= truncated tissue factor; NGR=Asn-Gly-Arg). The~     objectives of this trial are to evaluate the maximum tolerated dose (MTD) and the~     dose-limiting toxicity (DLT) of intravenously (iv) infused daily applications of tTF-NGR for~     5 days every 3 weeks in patients with cancer, who had obtained all standard treatment known~     for their disease entity prior to entry on study. Further objectives are to determine the~     perfusion and vascular volume fraction of measurable tumor lesions versus normal reference~     tissue before and after tTF-NGR application by MRI as a biological surrogate parameter for~     biological activity of the investigational medicinal product (IMP), tTF-NGR, and to obtain~     pharmacokinetic data.~   "
50776|NCT02902224|"~     The objective is to investigate neuro-anatomical correlates of the regulation of energy~     intake by means of functional MRI before and after bariatric surgery. Administration of~     glucose as well as fructose is followed by functional brain MRI, and findings are correlated~     with serum glucagon-like peptide 1 (GLP-1) levels as an endogenous satiety signal in obese~     humans.~   "
50777|NCT02902211|"~     This study will determine whether an ankle foot orthosis (AFO) improves walking performance~     in patients with PAD from its first use. Additionally, the study will test walking~     performance after a three month AFO intervention and will examine the feasibility of this AFO~     intervention.~      Data for evaluations will be collected from 50 patients with PAD. Fifty healthy age-matched~     controls will be participate in one baseline gait assessment for comparison purposes. Both~     groups between 40-85 years old.~      Interventions and Evaluations Biomechanics evaluations: Patients with PAD will complete a~     biomechanics evaluation at baseline, following three months of control (standard of care),~     and following three months of AFO intervention. The evaluation will include measurement of~     walking distances, gait function, physical activity, quality of life, energy cost, muscle~     morphometrics, muscle activity, muscle oxygenation, and muscle strength and endurance while~     walking with and without the AFO. Healthy controls will be assessed during one baseline~     collection only and their participation in the study will then be finished.~      Feasibility interview: All patients with PAD will participate in feasibility interviews that~     will assess acceptability, demand, implementation, and practicality. Interviews will occur~     1.5 months and following completion of the AFO intervention (not the control arm).~      AFO and Control (standard of care) Intervention: Patients will wear an off-the-shelf, carbon~     composite AFO that is adjusted for them for three months. The patients will be asked to wear~     the AFO at all times except when they are in bed or showering/bathing. The instructions given~     to the patients about walking will be to follow the instructions from their doctor regarding~     risk factor management and exercise. The intervention order will be randomized and all~     subjects will participate in both arms.~   "
50778|NCT02902198|"~     The objective is to investigate neuro-anatomical correlates of gastrointestinal taste~     stimulation by means of functional MRI before and after bariatric surgery. Intragastric~     administration of glucose, monosodium glutamate, chloroquine and placebo is followed by~     functional brain MRI in obese humans before and 3 months after surgery.~   "
50779|NCT02902185|"~     HIV replication can be effectively suppressed and acquired immunodeficiency syndrome(AIDS)~     can be prevented with highly active antiretroviral therapy (HAART). However, HIV-infected~     people must remain on treatment continuously to avoid viral rebound and progression to AIDS.~     HIV persistence is thought to stem primarily from the presence of integrated copies of the~     proviral genome within long-lived cells. Because active viral gene expression causes cell~     death due to viral cytopathic effects and the immune response, long-lived cells likely harbor~     transcriptionally silent, latent provirus. HIV-1 persistence in long-lived cellular~     reservoirs remains a major barrier to a cure. HDACi have the potential to activate (Kick)~     these latently infected cells. This will make the HIV infected cells visible to the immune~     system; the immune response and antiretrovirals(ARVs) will be able to attack and eliminate~     (Kill) the infected cells. This study is subsequent to our NCT02513901. The purpose of this~     study is to verify the efficacy of multi-dose Chidamide in combination with antiretroviral~     therapy in HIV-infected adults with suppressed viral load in a randomized controlled clinical~     trial.~   "
50780|NCT02902172|"~     Women who have the diagnosis of hypertension (pre-pregnancy and pregnancy induced) and~     deliver an infant via vaginal delivery will be placed into two groups in the postpartum~     period. One group will receive Ibuprofen for pain control and the other group will be given~     Tylenol. Blood pressures during the postpartum period will then be collected and compared in~     order to see if NSAIDs use increases blood pressure.~   "
50781|NCT02902159|"~     A randomised controlled trial to compare the effect on wellbeing of an online peer review~     website (Big White Wall) compared to freely available online information (NHS Moodzone) for~     people with depression and anxiety.~   "
50782|NCT02902146|"~     This prospective, open-label trial randomizes adult patients intubated in the ED with a~     Macintosh blade to use or not use a bougie for the first intubation attempt. The primary~     outcome is first pass success.~   "
50783|NCT02902133|"~     This is a non-randomized pilot study of Acetazolamide administration in patients at high risk~     for CSF leak after endoscopic skull base surgery.~   "
50797|NCT02901951|"~     The purpose of this study is to assess the long-term protection against HBV infection in~     adult subjects, aged 18-40 years vaccinated with three or four doses of Engerix-B 20 to 30~     years ago~   "
50785|NCT02902107|"~     This study is a pilot study of the CivaSheet, a new type of intraoperative radiation therapy~     (IORT) device that offers several advantages over existing techniques of performing IORT. The~     CivaSheet device in this study is already approved by the FDA and is not an experimental~     device. This study will allow us to determine how feasible it is to implant the CivaSheet~     into patients undergoing surgery for abdominal and pelvic tumors, and assess any possible~     side effects of the device. This study, if successful, may allow us to offer the CivaSheet~     more widely as treatment option to future patients.~   "
50786|NCT02902094|"~     DeVA is a single blinded, prospective, multicentre RCT designed to determine the safety and~     effectiveness of a drug eluting angioplasty balloon compared with a standard angioplasty~     balloon in patients with symptomatic native AV fistula stenosis.~   "
50787|NCT02902081|"~     The purpose of this research is to examine the effect of cannabidiol (CBD), a cannabinoid~     compound found in marijuana, on responses to emotional stimuli. Both preclinical and clinical~     studies indicate that CBD may act to reduce anxiety without excessive sedative side-effects.~     Thus the investigators hypothesize that CBD may reduce responses specifically to negative~     emotional and social stimuli, including pictures and emotional faces, without altering~     responses to positive stimuli. To examine this, the investigators will administer placebo,~     300mg, 600mg, and 900mg CBD to healthy normal adults in a double-blind within-subjects study.~     The investigators will measure subjective and subtle physical responses to positive and~     negative stimuli using measures that have been characterized with classic anxiety-reducing~     drugs and drugs of abuse. Further, the investigators will examine whether CBD-induced changes~     in these measures of emotional response relate to changes in actual behavior in a controlled~     social interaction. These results will allow the investigators to examine the potential~     usefulness of CBD as an anxiety-reducing drug, and suggest mechanisms by which CBD may reduce~     anxiety.~   "
50788|NCT02902068|"~     In this study we would like to monitor cardiac output by the use of NICAS bioimpedance in~     women undergoing cesarean section delivery.~      This study is a purely observational study, it will not have any clinical intervention nor~     will it interfere with standard cesarean delivery protocols in any way. This study's primary~     objective is to evaluate how spinal and general anesthesia influences cardiac output during~     cesarean section deliveries. Secondary endpoints is whether the hemodynamic changes as~     measured in cardiac output correlate with women's pain, measured by a visual analogue~     scale(VAS) from o-10. (0=representing no pain at all, 10= worse pain imaginable)~   "
50789|NCT02902055|"~     Paediatric acute respiratory distress syndrome (ARDS) is a manifestation of severe,~     life-threatening lung injury. Care for paediatric patient is mainly supportive and based on~     what works in adults and personal experiences, including the use of mechanical ventilation.~     However, differences in lung physiology and immunology between (young) children and adults~     suggests that adaptation of adult practices into paediatrics may not be justified. A study in~     adults with severe ARDS showed that early use of neuromuscular blocking agents (NMBA)~     improved 90-day survival and increased time off the ventilator without increasing muscle~     weakness. It is unknown if this is also true for paediatric ARDS~   "
50790|NCT02902042|"~     This study will investigate the influence of maintenance therapy on progression-free survival~     (PFS) and overall survival (OS) after combination therapy with BRAF/MEK (MAP-ERK kinase)~     inhibitors and PD-1 antibody pembrolizumab.~      In the safety phase I part the optimal dose of pembrilizumab in combination with BRAF~     inhibitor and MEK inhibitor and the safety of this three-drugs-combination regime will be~     determined.~      In the randomized part 2 different maintenance therapies will be tested for toxicity and~     efficacy. Patients with disease control after 6 months of triple therapy will be randomized~     to receive 2 different maintenance therapies further on, either continuation of triple~     therapy or administration of pembrolizumab alone.~   "
50791|NCT02902029|"~     Most patients with locally advanced or metastatic tumors succumb to their disease. Thus,~     there is a substantial need for novel therapeutic strategies to improve the outcome for~     patients with advanced or metastatic melanoma. Targeting the the Ras/Raf signalling pathway~     by BRAF and MEK inhibition as well as targeting immunologic checkpoint control with an~     antiPD-L1 antibody have emerged as treatment option.~      In this study the best timing for sequential use of both treatment options (BRAF/MEK~     inhibition and antiPD-L1 antibody) in patients with unresectable or metastatic BRAFV600~     mutant melanoma will be assessed.~   "
50792|NCT02902016|"~     This study is designed to assess the effect of a new PPARgamma modulator on the expression~     and activity of the lactase enzyme in human intestinal epithelial cells. Based on their~     previous experimental results, the investigators hypothesized that modulating intestinal~     PPARgamma activity is a new pharmacological mechanism allowing the control of lactase~     expression and activity in the gut~   "
50793|NCT02902003|"~     The Parenting Center (TPC) offers the Empowering Families program, which integrates a~     relationship education curriculum (Family Wellness) into a comprehensive set of services that~     includes case management, employment services, and financial coaching. The evaluation will~     test the effectiveness of offering relationship skills education services with a robust~     economic security component to low-income couples raising children.~   "
50794|NCT02901990|"~     This study was aimed to conduct a 3-year perspective study to observe the immunological~     effect of one-dose mumps-containing vaccine, monitor the incidence of mumps in vaccinated~     population aged 3-7 years，and provide basis for adjusting MMR immunization strategy in~     Jiangsu province, China.~   "
50795|NCT02901977|"~     Randomized double-blind parallel group study in patients with mild-to-moderate hypertension~     to evaluate the effects beyond the blood pressure lowering effect of treatment for 12 weeks~     with ramipril or doxazosin on hemostatic mechanisms and on endothelial function.~   "
50796|NCT02901964|"~     Osteoarthritis (OA) is a prevalent disease associated with significant morbidity and is one~     of the most common causes of joint pain. Characterized by their chronicity, slow and~     progressive evolution. The overall prevalence of symptomatic knee osteoarthritis is estimated~     at 3.8%, with peak prevalence in the population with an average age of 50 years. The main~     objectives of interventions in patients with knee OA are reduced pain and improved functional~     capacity and exercises are widely recommended. The literature shows a lack of clinical trials~     verifying the effect of strengthening the hip muscles in patients with knee osteoarthritis.~     Thus, the aim of this study is to assess the effect of strengthening the hip abductor muscles~     versus hip adductor muscles in patients with symptomatic OA of the knee.~   "
50798|NCT02901938|"~     This study will investigate the effects of implantation of cemented femoral stem versus~     percutanous internal fixation with cannulated compression screws on hip joint function~     recovery, pains, femoral head collapse and sterile prosthesis loosening, peri-prosthesis~     infection, and the histocompatibility of prosthesis material with host tissue in the elderly~     patients with osteoporotic fracture of proximal femoral neck complicated by avascular~     necrosis of the femoral head, which will provide scientific evidence for selecting surgical~     methods and internal fixation/artificial prosthesis material for osteoporotic fracture of~     proximal femoral neck in the elderly patients.~   "
50799|NCT02901925|"~     The primary study objective is to determine if microdoses of ABY-029 lead to detectable~     signals in sampled tissues with an EGFR pathology score ≥ 1 based on histological staining.~      The secondary study objective is to assess diagnostic accuracy of ABY-029 detection by iFI~     and intraoperative probe relative to histopathology diagnosis, and other indicators (e.g.~     proliferation, infiltration, etc.) as the gold standard, and to measure the molecular uptake~     and concentration of ABY-029 in resected specimens.~   "
50800|NCT02901912|"~     Gut microbiota comparison of active and sedentary women~   "
50801|NCT02901899|"~     The purpose of this study is to look at how patients respond to treatment with guadecitabine~     and pembrolizumab. The researchers will also be looking at the amount of time it takes for~     cancer to get worse when participants take the study drugs. All participants will be treated~     with guadecitabine and pembrolizumab. Guadecitabine interferes with the cancer cells' DNA and~     can increase the production of certain proteins, making cancer cells more recognizable by the~     immune system. Pembrolizumab helps your immune system to kill cancer cells. Thus the~     combination of guadecitabine and pembrolizumab may increase the ability of the immune system~     to eliminate cancer cells. Researchers want to find out whether the combination of~     guadecitabine and pembrolizumab is effective in treating ovarian cancer that has not~     responded to traditional chemotherapy. Participants will keep receiving treatment until their~     cancer gets worse, they have side effects, or they decide they don't want to receive the~     treatment anymore. After stopping treatment, the study doctor will watch participants for~     side effects and follow their condition every 6-12 weeks. The study aims to keep track of~     participants' medical conditions for the rest of their lives. This helps us look at the~     long-term effects of the study drugs.~   "
50802|NCT02901886|"~     This study aims to test the effect of an intensive smoking cessation intervention~     (motivational counseling combined with nicotine replacement) on smoking cessation and disease~     activity in patients with Rheumatoid Arthritis (RA). Half of the patients will participate in~     a smoking cessation intervention; the other half will receive usual treatment.~   "
50803|NCT02901873|"~     Parathyroid glands are involved in calcium metabolism and their damage during neck surgery~     results in 'hypoparathyroidism', a condition characterized by 'low blood calcium' levels;~     this is associated with significant short and long term morbidity. There are four parathyroid~     glands in the neck which can vary in size and location. They can be mistaken for lymph nodes,~     fat or thyroid nodules. A normal parathyroid gland is the size of a small pea and is often~     difficult to recognize during surgery; making it susceptible to inadvertent injury or~     removal.~      Thyroid and parathyroid surgery are commonly performed in the UK. Prompt and accurate~     identification of parathyroid tissue during surgery reduces the likelihood of~     hypoparathyroidism. However, this complication is still common. Research exploring the use of~     intraoperative technologies to enable early identification and preservation of normal~     parathyroid glands during surgery is ongoing. Electrical impedance spectroscopy (EIS) is one~     such technology. ZedScanTM is a handheld device that measures electrical impedance of~     tissues. It is currently used as a adjunct during colposcopy in cervical cancer screening.~     The device has a CE mark for this purpose and is safe to use in humans. We have already~     demonstrated that electrical impedance spectroscopy can detect differences in cellular~     structure and differentiate between tissues in the rabbit neck. We now aim to demonstrate the~     feasibility of using this technology (ZedScanTM) in humans. This has potential to be used in~     thyroid and parathyroid surgery to differentiate parathyroid glands from other structures;~     thereby decreasing their damage and the risk of post surgical hypothyroidism.~   "
50804|NCT02901860|"~     The purpose of this research is to test the hypothesis that those with non-traditional work~     schedules (e.g. shift workers) have a higher cardio-metabolic risk than those with~     traditional work schedules (e.g. day workers), and that both accumulated sleep debt and the~     degree of circadian disruption predict the elevated cardio-metabolic risk. The findings of~     this research are expected to increase our understanding of physiologic tolerance to~     non-traditional work schedules and provide the basis for the development of methods for the~     early detection of adverse health effects and determine coping strategies for the millions of~     workers with non-traditional work schedules.~   "
50805|NCT02901847|"~     The aim of the project is to investigate the clinical and patient centred outcomes of people~     with Peripheral Arterial Disease (PAD) attending a podiatry led integrated care pathway,~     utilising advice on diet, activity and smoking cessation. The podiatry clinic will be~     delivered from the Move More centre (NCSEM) and participants will be encouraged to access~     these facilities as part of their activity programme which will be agreed with the physical~     activity team. Primary and secondary outcomes will be clinical - claudication pain, distance~     walked at 3 and 6 months, blood pressure and lipid monitoring, weight management, reduced~     BMI, and the success of any smoking cessation. Quality of life and patient satisfaction with~     the programme will also be assessed.~   "
50806|NCT02901834|"~     Adolescents with cancer (AWC) are in a unique developmental stage that may mean pain~     characteristics, the impact of pain, and pain treatment outcomes are different in adolescents~     compared to children and adults. In response, we will develop and test the PainSquad+ pain~     management smartphone app. First, we will conduct usability testing to refine PainSquad+ so~     that it is useable, acceptable and understandable for AWC. Secondly we will: (a) test the~     feasibility of conducting a large-scale PainSquad+ experiment and (b) begin to examine how~     effective PainSquad+ is at helping adolescents manage pain. We hope that once developed and~     tested for effectiveness, PainSquad+ will improve pain treatment and ultimately quality of~     life in AWC.~   "
50807|NCT02901821|"~     The purpose of this study is to identify changes in salivary micro ribosomal nucleic acid~     (miRNA) expression that are predictive of symptom duration and severity following mild~     traumatic brain injury (mTBI) in children.~   "
50809|NCT02901795|"~     All included patients will have their fetal heart rate recording performed with an EDAN F3~     fetal monitor that allowed the back up recording of the fetal heart rate beat to beat~     detection. Fetal heart rate variability analysis will be performed using Matalb® software.~   "
50810|NCT02901782|"~     Microwave ablation of bone tumors is time-consuming and usually results in postoperative~     fractures. Hence the investigators designed and fabricated a titanium plate customized to the~     patient's bone structures for fixation after the removal of tumorous tissue, to improve the~     clinical outcomes of microwave ablation.~   "
50811|NCT02901769|"~     Suicide is known to be frequent in depression, and in most of the psychiatric diseases. But~     as it can occur in patients with no psychiatric illness and doesn't occur in every patients~     with psychiatric illness, it has to be considered henceforth as a specific vulnerability.~      This trial will study two fMRI paradigms, emotional prosody recognition and decision making,~     in order to characterize emotional and cognitive trait factors in a population of patients~     vulnerable to suicide. Four different groups will be constituted : depressed suicide~     attempters, depressed patients with past history of suicidal acts, depressed patients with no~     history of suicidal acts and healthy controls.~      The main goal will be to correlate fMRI activation during the two paradigms in subjects~     vulnerable to suicide. The secondary goals will be to characterize emotional and cognitive~     trait factors in these subjects, to demonstrate that those characteristics are independent~     from depression and to correlate these trait factors with socio-demographic and clinical~     features with fMRI activations.~   "
50812|NCT02901756|"~     Adult patients suffering from migraine according to the criteria of the International~     Headache Society were enrolled by general practitioners (≥2 migraine attacks during previous~     month; exclusion of chronic migraine and medication overuse) and after a one-month baseline~     phase, supplemented with one tablet of 100 mg feverfew, 100 mg coenzyme Q10 and 112.5 mg~     magnesium per day for 3 months.~   "
50813|NCT02901743|"~     The main aim and objective of this study was to evaluate the effects of Non- surgical~     periodontal therapy on the subgingival microbiota and biochemical parameters in patients with~     chronic kidney disease and chronic periodontitis.~   "
50814|NCT02901730|"~     Glaucoma is the second cause of blindness worldwide. Laser peripheral iridoplasty (LPI) is a~     simple and effective treatment for angle closure glaucoma. LPI can widen or reopen an~     existing angle close or angle adhesion in order to reduce the risk of attack of the angle~     closure glaucoma. However, there are very little research on the laser site, laser~     wavelengths, laser energy and laser spot intervals. The purpose of this study is to determine~     the optimum laser wavelengths of LPI.~   "
50815|NCT02901717|"~     This is a Phase 3, multi-center, randomized, double-blind study to determine the efficacy and~     safety of MLT, a novel antibiotic lock therapy that combines minocycline with edetate~     disodium in 25% ethanol solution.~      Approximately 700 subjects who have been diagnosed with CRBSI/CLABSI and who meet all~     necessary criteria for the study will be randomized in a 1:1 ratio to 1 of 2 treatment arms:~        -  MLT Arm: MLT + SOC intravenous (IV) antibiotic therapy; or~        -  Control Arm (subjects randomized to the Control Arm will receive treatment based on the~          type and virulence of the infecting organism as documented by the Investigator prior to~          randomization)~   "
50816|NCT02901704|"~     The purpose of Iberis-HTN trial is to evaluate the safety and effectiveness of renal~     denervation in subjects with primary hypertension by using Iberis multielectrode renal~     denervation system~   "
50817|NCT02901691|"~     The deaf children showed deficits in speech processing and temporality. They badly apprehend~     temporal concepts and perceptions of deficit so the acoustic phenomena marking the time~     course linguistically. Their prediction capabilities and anticipation multisensory events are~     thereby affected, thus impacting their ability to adapt to multiple and complex interaction~     possibilities that arise during a conversation.The project aim it is to measure the impact of~     a musical rhythmic stimulation of neuronal activity and the temporal prediction capabilities~     of older deaf children 5 to 8 years and its impact on their language skills in a~     conversational task. A matched control group of age will be examined for each of the proposed~     tasks.~      We first measure the capacity to anticipate a situation of language interaction. For this~     purpose, we will use an alternate naming paradigm with a virtual partner, already developed~     and tested in children with normal hearing. This paradigm approaches the conversational~     situation while allowing control of the time parameter of speech (speed of trade) and by~     controlling the bias (temporal) inherent linguistic programming difficulties of children in a~     spontaneous conversation situations .~      Then we will couple behavioral measurements with measurements of eye movements and the~     electroencephalogram (EEG) in deaf children. For this, we use a dialog observation task~     already developed for normal hearing children. This task will allow us firstly to analyze the~     anticipation level of speaking turns by analyzing eye movements (which precedes the~     speaker). Secondly, it will allow us to study the effects of manipulation of the acoustic~     parameters of auditory evoked potentials (AEP) and the oscillatory activity of the motor~     system (EEG, mu rhythm and beta). The audiomoteur coupling would seem to be the key point of~     anticipatory processes and convergence in conversational interaction will also be studied~     using cortico-cortical coherence techniques to assess the dynamics of connectivity between~     remote networks (system here auditory and motor system).~   "
50818|NCT02901678|"~     A Randomized clinical trial comparing two different force magnitudes in maxillary posterior~     segment intrusion in adult patients with skeletal open bite malocclusion~   "
50819|NCT02901665|"~     The purpose of this pilot study is to compare parent and infant outcomes and unit outcomes~     pre and post a planned unit-wide intervention aimed at increasing parent presence in the~     Neonatal Intensive Care Unit (NICU). The FCC intervention will consist of communicating an~     expectation that all NICU parents be present at minimum 4 hours/day versus the current~     practice of telling families to come as much as they can that has resulted in inconsistent~     parent presence.~   "
50820|NCT02901652|"~     Purpose is to compare introduction of NIPPV (Nasal Intermittent Positive-Pressure~     Ventilation) and nBiPAP (Nasal Bi-level Positive Airway Pressure) in terms of mechanical~     ventilation (MV) need (non-invasive respiratory support failure) and surfactant need within~     the first 72 hours of life in preterm infants with Respiratory Distress Syndrome (RDS) at~     26-30 weeks of gestation.~   "
50821|NCT02901639|"~     Unwanted pregnancies are not only the major cause of maternal mortality and morbidity but are~     also a great social and financial burden on societies and countries. According to~     World-health-organization statistics, there are an estimated 200 million pregnancies around~     the world each year, and a third of these, 75 million, are unwanted. Unintended pregnancy~     also is a major health problem in the United States of America. In the 2002 National Survey~     of Family Growth assessment, 1.22 million, or 31%, were reported as unintended. When~     abortions were included, unintended pregnancies increased to 2.65 million, or 49% of all~     pregnancies~   "
50822|NCT02901626|"~     The purpose of the study is to determine whether the Arabin pessary is a useful intervention~     of preterm birth at less than 37 weeks in women with a singleton gestation and a short~     cervix.~   "
50823|NCT02901613|"~     To evaluate the effectiveness of negative-pressure wound therapy in decreasing wound~     complications in morbidly obese patients (BMI greater than of equal to 40) at Albany Medical~     Center Hospital. Retrospective data will be collected regarding morbidly obese patients who~     have undergone cesarean section and patients will be recruited to have the intervention~     (negative-pressure wound therapy) applied and outcomes will be evaluated.~   "
50824|NCT02901600|"~     Although colorectal cancer is a preventable and curable disease if early stage tumors are~     removed, it is still the fourth cause of cancer worldwide and the second leading cause of~     death in many industrialized countries. The 5-year survival is about 55% often due to a late~     detection. Then, the identification of sensitive and specific molecular markers is therefore~     a major challenge for early diagnosis and prognosis of this disease.~      Preliminary work have reported variations in the expression of DMBT1 (deleted in malignant~     brain tumor 1), a glycoprotein co-secreted with mucins in the light of the glands, during~     several stages of colon carcinogenesis. The goal of this study is to study by mass~     spectrometry (MS), alterations in the repertoire of glycosylation of mucins from colorectal~     tumors of various stages, grades, and recurrence status.~   "
50825|NCT02901587|"~     The purpose of this study is to investigate the effect of Lu AF35700 on electrical activity~     in the heart as measured on an electrocardiogram (ECG) in patients with schizophrenia or~     schizoaffective disorder after 6 weeks of treatment~   "
50826|NCT02901574|"~     People with post-stroke aphasia are left with some degree of chronic deficit for which~     current rehabilitative treatments are variably effective. This study investigates the~     behavioral and neural effects of multiple consecutive cerebellar tDCS sessions coupled with~     computerized naming therapy in stroke survivors with aphasia.~   "
50827|NCT02901561|"~     The purpose of the investigators' study was to evaluate whether misoprostol will improve pain~     scores .~   "
50828|NCT02901548|"~     The purpose of this study is to test if an experimental drug called Durvalumab (Medi4736)~     given by intravenous (IV) infusion is effective in treating carcinoma in situ (CIS) of the~     bladder that no longer responds to Bacillus Calmette-Guérin (BCG) and to collect information~     on the safety of these drugs and whether they cause any side effects.~   "
50829|NCT02901535|"~     The purpose of this study is to determine the effectiveness of telemedicine multifaceted~     intervention in symptoms patients with chronic obstructive pulmonary disease.~   "
50830|NCT02901522|"~     The purpose of this study is to determine the effectiveness of telemedicine multifaceted~     intervention in symptoms patients with asthma.~   "
50831|NCT02901509|"~     QoLCHIK study aims at evaluating impact of chikungunya infection on the quality of life of~     infected people during the 2005-2006 outbreak in Reunion Island and followed in the TELECHIK~     cohort by comparing scores of SF-36 health survey.~   "
50832|NCT02901496|"~     Aim: Exercise training improves the risk of cardiometabolic diseases; yet the underlying~     mechanisms are unclear. Exercise induces release of IL-6 from skeletal muscle. Acute~     elevations in IL-6 improve lipid and glucose metabolism, the latter partly through a delayed~     gastric emptying. Physical inactivity causes accumulation of visceral fat (VAT). Visceral and~     epicardial adipose tissue (EAT) is more inflamed than subcutaneous adipose tissue. Thus, the~     investigators hypothesize that exercise-induced IL-6 mediates the exercise-induced reduction~     in EAT and VAT. Secondly, the investigators hypothesize that exercise-induced adaptations in~     glucose metabolism and gastric motility are dependent on IL-6. Finally the investigators~     hypothesise that both endurance and resistance exercise training reduce VAT and EAT.~      Primary aim: To investigate the effects of exercise training on VAT and to determine to what~     extend IL-6 mediates this effect.~      Secondary aims: 1) To determine whether 12 weeks of endurance and strength training can~     reduce the amount of EAT. 2) To study whether the effects of exercise on glucose metabolism~     and gastric emptying are dependent on IL-6.~      Methods: Inclusion: 70 inactive men and women, >18 years, waist to height ratio > 0.5 and/or~     waist circumference ≥ 88 cm (women); waist circumference ≥ 102 cm (men) Design: A 12-week,~     double-blinded randomised, placebo-controlled exercise intervention study.~      Intervention: Subjects will be randomised to one of five groups: i) Tocilizumab (IL-6~     receptor antibody) and endurance training, ii) Placebo to Tocilizumab and endurance training,~     iii) Tocilizumab, no exercise iv) Placebo to Tocilizumab and no training, and v) Placebo to~     Tocilizumab, and resistance training. Tocilizumab/placebo dose will be administered~     (according to standard recommendations) before the first training session, and maintained~     during the 12-week training program. Training will be supervised to ensure intensity and~     compliance. Subjects will be instructed not to change eating habits and informed that this~     study does not aim for a weight loss.~      Statistical considerations: Study investigators are blinded to treatment allocation. Dropouts~     will be replaced. A sample size of 70 subjects is needed to detect a 10% change in visceral~     adipose, with a power of 80% and a significance level of 0.05.~   "
50833|NCT02901483|"~     It's a prospective, open-label, single arm, nonrandomized study of PEP503 in head and neck~     squamous cell carcinoma (HNSCC) patients.~        -  Escalation portion (Phase 1b):A 3 + 3 dose escalation study design will be adopted in~          this phase to identify the recommended intratumor injection volumes of PEP503.~        -  Expansion portion (Phase 2): Following confirmation of the recommended volumes, 18~          additional patients will be enrolled at the recommended volume level to evaluate for~          safety and efficacy.~   "
50834|NCT02901470|"~     The support of help to the prevention of sores include a big diversity of devices. The~     clinical experiment of these support comes up against the problem of the large number of~     factors participants in the genesis of bedsores. Nevertheless, it seems to be interesting to~     estimate the incidence of bedsores in these supports, with control of other factors~   "
50835|NCT02901457|"~     Too many Norwegian adolescents experience severe body dissatisfaction (40-70 %), and strive~     to accomplish the perfect body. At the same time, only 50 % meet the government`s~     recommendations on physical activity and intake of fruits and vegetables. Also, 14-24 % has~     unhealthy sleeping habits. Optimizing these lifestyle factors is associated with physical and~     psychological health. These factors, along with the pressure to obtain the perfect body,~     are threatening the adolescent`s physical and psychological health, jfr. Meld St nr 19. It is~     now a need for knowledge on how the investigators can contribute to promote positive body~     experience among the adolescents.~      It has recently, through a controlled study on elite youth athletes at Norwegian sports high~     schools, been shown that it is possible to change eating habits, improve body image and~     reduce new cases of eating disorder. It is now desirable to test an adapted program through a~     school-based program at regular Norwegian high school students (12th grade). Today, no~     controlled, school-based intervention studies with long-term follow-up have been conducted.~      The main aim of this project is to investigate if it is possible, through a school-based~     intervention program (Healthy Body Intervention), to promote positive body image, increase~     physical activity level, and healthy eating and sleeping habits in both boys and girls at~     Norwegian high schools.~      The intervention program will contribute with new evidence-based knowledge on the effect of~     an adapted health-promoting program.~   "
53581|NCT02865629|"~     N-acetylcysteine in the treatment of depressive symptoms in youth at high-risk for bipolar~     disorder: a functional connectivity study~   "
50836|NCT02901444|"~     Stemming from the common practice of attribution of the technical helps in the posture in~     Canada, the multidisciplinary approach of positioning develops in France for more than 10~     years old.~      To date, no observatory study was led to estimate the impact of such consultation in daily~     activities, an essential objective conditioning the observance and the acceptance of~     assistive devices. This study wants to estimate the impact through modification of WHOM~     scale.~   "
50837|NCT02901431|"~     This is a Phase II multi-center, randomized, double-blind, 24-week, 3-arm, parallel group,~     placebo-controlled study to investigate the efficacy, safety, and pharmacokinetics of~     RO5285119 in children and adolescents aged 5-17 years with ASD who are high functioning~     (intelligence quotient [IQ] greater than or equal to [>=] 70). Enrollment will be staggered,~     starting first with adolescents (aged 13 to 17 years) and then with children (aged 5 to 12~     years). Initially, a first cohort of approximately 24 adolescents will be enrolled together.~     Based on pharmacokinetic evaluation, safety, and tolerability in the first adolescent cohort~     and determined final doses, enrollment of adolescents will resume and the enrollment of a~     first cohort of approximately 24 children (aged 5 to 12 years) can commence. Based on~     acceptable safety and tolerability in the first children cohort and determined final doses,~     enrollment of children will resume.~   "
50838|NCT02901418|"~     Chronic hepatitis B (CHB) is a serious liver disease worldwide，HBV MTCT is the important~     reason to keep high prevalence of chronic HBV infection in China. Intrapartum infection is~     the main period of neonatal HBV infection. Injecting HBIG and hepatitis b vaccine immediately~     after birth is the most important method of blocking mother-to-child transmission of HBV.~     However, regular doses of HBIG combined with hepatitis b vaccine blocking measures still have~     a failure rate as high as 5% ~ 15%.There are numerous studies to explore pregnancy women with~     HBV positive, especially high viral load of those women during pregnancy being treated with~     nucleoside analogs to increase the blocking rate of HBV MTCT, but there is still a failure~     rate of 2.2% to 18%. In this study, we will explore the efficiency of personalized blocking~     method of HBV maternal-neonatal transmission in high-risk newborns,according to the venous~     blood HBsAg state of neonatus at birth.~   "
50839|NCT02901405|"~     This randomised controlled trial aims to evaluate the difference in surgical site infection~     following excision of soft tissue sarcomas. The intervention is a negative wound pressure~     therapy dressing for 120 hours, the control is standard absorbent dressings~   "
50840|NCT02901392|"~     Stress urinary incontinence is a significant potential source of morbidity after radical~     prostatectomy or radiation therapy for prostate cancer. At present, artificial urinary~     sphincter remains the preferred therapeutic option. However, this technique is not free from~     complications. In an attempt to avoid such complications, male sling has been suggested for~     use in patients with mild degrees of stress incontinence.~   "
50841|NCT02901379|"~     The purpose of this study is to determine whether atorvastatin 80mg can reduce the~     development of myocardial edema following coronary artery bypass surgery.~      This study also want to determine:~        1. whether atorvastatin 80mg can influence Follistatin-like 1 (FSTL1) plasma level~          following bypass surgery?~        2. whether there is correlation between myocardial edema and FSTL1 plasma level?~        3. the efficacy of atorvastatin 80mg compared to atorvastatin 10mg in reducing hs-CRP (high~          sensitive-C reactive protein) and MDA (malondialdehyde) plasma level following bypass~          surgery?~        4. the efficacy of atorvastatin 80mg compared to atorvastatin 10mg in raising PKA and PKB~          plasma level following bypass surgery?~   "
50842|NCT02901366|"~     To assess the plasma pharmacokinetics, the routes extent of elimination, and the metabolites~     of FYU-981 after a single 1 mg oral dose of 14C-FYU-981 in healthy male subjects.~   "
50843|NCT02901353|"~     A prospective, single-arm, multi-centre, observational, real world registry to evaluate~     safety and performance of the BioMime™ Morph Sirolimus Eluting Coronary Stent System for very~     long coronary lesions.~   "
50844|NCT02901340|"~     The purpose of the study is to investigate third trimester fetal renal artery doppler indices~     in borderline idiopathic isolated oligohydramnios and relationship between neonatal outcomes.~   "
50845|NCT02901327|"~     Chronic Mechanical Low Back Pain (CMLBP) is a common disabling health problem among the~     general population. Multifidus muscle inhibition accompanying CMLBP plays a major role in~     perpetuating the pain and functional disability. Lumbar stabilisation and treadmill exercises~     are established treatments for CMLBP. However, it is not known which of the two techniques is~     more effective. This study was conducted to compare the effects of lumbar stabilisation and~     treadmill walk on multifidus activation, pain and functional disability in individuals with~     CMLBP.~   "
50846|NCT02901314|"~     Non-adherence to the heart failure (HF) plan of care after hospital discharge has been~     associated with clinical outcomes, including the combined endpoint of all-cause mortality and~     rehospitalization for decompensated HF. Patients and informal caregivers receive education~     materials but may not act due to multiple factors. A recorded message that could be~     repeatedly played by patients and caregivers might increase adherence to post-discharge~     self-care behaviors and early follow-up appointments, and have clinical benefits related to a~     reduction in all-cause mortality and rehospitalization. The purposes of this randomized,~     controlled study are to examine the effects of use of a novel MyROAD (Recordable On-Demand~     Audio Discharge) card, given to patients at discharge. The aims of this single-blind,~     placebo-controlled study are to examine the effects of recorded messages that can be replayed~     post discharge (delivered via the MyROAD card) on multiple subjective and objective clinical~     outcomes.~   "
50880|NCT02900872|"~     Systematic retrospective study of medical charts and medical imaging files, of patients~     consulting for acute neck pain and presenting unclassified abnormalities on dedicated vessel~     imaging.~   "
50881|NCT02900859|"~     Systematic medical chart and imaging files review of patients presenting with non-lymphoma,~     non-thyroid-related orbital inflammation. The review aims at comparing the frequency of MRI~     infra-orbital nerve enlargement, between patients diagnosed with an IgG4-related ophthalmic~     disease (IgG4-ROD) and other patients.~   "
50882|NCT02900846|"~     Retrospective medical charts and medical imaging files review of patients suffering from~     lacrimal fossa lesions who underwent ocular ultrasonography with color flow doppler imaging.~   "
53416|NCT02867774|"~     The purpose of this pilot study is to evaluate the impact of an intervention to increase~     physical activity on pain, function and quality of life in women with chronic pelvic pain.~   "
50847|NCT02901301|"~     Gastric cancer is one of the major health problems worldwide, and one of the leading cause of~     death especially in Asia. Though the cytotoxic chemotherapy is the main treatment option,~     newer and molecularly targeted agents are recently incorporated to improve the survival~     outcome. Human epidermal growth factor receptor 2 (HER2, ErbB2) is a transmembrane tyrosine~     kinase receptor and is overexpressed or amplified in 10-20% of gastric cancer. Recently,~     Trastuzumab for Gastric Cancer (ToGA) study reported the clinical benefit of trastuzumab for~     HER2 positive gastric cancer patients. However, because the majority of patients develop~     intrinsic or acquired resistance within 1 year, elucidating the molecular mechanisms for~     trastuzumab resistance is warranted to improve the survival outcome of HER2 positive gastric~     cancer patients.~      A growing body of preclinical and clinical evidence shows that the immune system contributes~     substantially to the therapeutic effects of monoclonal antibody, trastuzumab in solid~     tumors. Pembrolizumab is a potent and highly selective humanized monoclonal antibody designed~     to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2.~      Based on strong rationale in exploring the impact of combining trastuzumab with anti-PD-1~     inhibitor in HER2 positive cancer, we suggest multicenter phase IB/II study to determine~     antitumor activity and safety of pembrolizumab in combination with standard treatment~     (trastuzumab, capecitabine, and cisplatin) in patients with HER2 positive gastric cancer.~   "
50848|NCT02901288|"~     The purpose of the study is to evaluate the safety and efficacy of two shortened regimens for~     newly diagnosed smear positive drug susceptible pulmonary tuberculosis in comparison to World~     Health Organization recommended standard 6-month regimen.~   "
50849|NCT02901275|"~     This research is being done to evaluate whether combining medications that are FDA approved~     but have not yet been approved for combination treatment, can be an effective way to reduce~     pain.~   "
50850|NCT02901262|"~     To evaluate the ability of NICU staff to interpret, before and after a training period,~     symmetry, sedation level, seizures activities and artefact on continuous cEEG/qEEG tracings.~   "
50851|NCT02901249|"~     To evaluate the effectiveness of one algorithm for Major Depression Disorder (MDD) using~     medications available in the Brazilian Public Healthcare System (SUS), and assessment of the~     quality of life of these patients.~      A randomized pragmatic trial was conducted. An algorithm was developed for the treatment of~     episodes of unipolar depression episodes.~   "
50852|NCT02901236|"~     Refractory glaucoma often requires vision-sparing trabeculectomy. To increase surgical~     success, adjunctive pharmacotherapy is utilized albeit the risk of adverse events. This~     prospective trial randomizes adults with uncontrolled glaucoma to assess an emerging healing~     modulatory strategy. Over a 1-year follow-up, trabeculectomy complemented with intracameral~     delivery of anti-angiogenic bevacizumab (1.25 mg) is compared to standard trabeculectomy with~     anti-fibrotic mitomycin-C (0.02%; applied for 2 minutes).~   "
50853|NCT02901223|"~     The aim of this study is to asses the oncological safety of oncoplastic breast surgery, its~     impact on patient satisfaction and is it worthy for general breast surgeon to learn different~     oncoplastic techniques.~   "
50854|NCT02901210|"~     The aim of this study is to evaluate the investigator new modification for delorme procedure~     in patients with rectal prolapse , assessing intra-operative morbidity and recurrence rate .~   "
50855|NCT02901197|"~     The purpose of this dual-site quasi-experimental pilot study is to evaluate if the~     implementation of an educational intervention paired with an environmental assessment to~     address accessibility barriers is associated with improvement in staff knowledge and skills,~     and adherence to national guidelines for use (evaluation in the knowledge transfer framework)~     in an emergency department (ED) setting.~   "
50856|NCT02901184|"~     Heart failure with preserved ejection fraction (HFPEF) is common and deadly but without~     therapy. Inconclusive studies such as TOPCAT (Treatment of Preserved Cardiac Function Heart~     Failure With an Aldosterone Antagonist) suggest spironolactone may be effective in HFPEF, but~     it is generic and will not be studied by industry.~      SPIRRIT is a unique Registry-Randomized Clinical Trial (RRCT) that will test the hypothesis~     that spironolactone reduces all-cause mortality in HFPEF and is summarized by PICO (Patient~     Intervention Comparison Outcome) as follows: Population: HFPEF patients in the Swedish Heart~     Failure Registry. HFPEF defined as symptoms/signs of HF, elevated NTproBNP (B-type~     Natriuretic Peptide; N-terminal pro b-type Natriuretic Peptide) and EF>=40%. Intervention and~     control: Randomized 1:1 to intervention: spironolactone + usual care vs. control: usual care~     alone.~      Outcome: Primary outcome all-cause mortality. Secondary outcomes include hospitalization for~     various causes, adverse events and treatment adherence. Outcomes are obtained automatically~     by linking with the Population, Patient and Drug Dispensed Registries. The trial is~     event-driven with enrollment 3 years and study duration 5 years. Based on actual patients~     meeting eligibility 2008-2010, the control death rate is 0.141 / year. Based on TOPCAT and~     accounting for dropouts, the investigators conservatively assume hazard ratio 0.85, or a~     clinically meaningful 15% reduction in death, yielding a required number of events of 1208~     and a sample size of 3335, conservatively rounded to 3500. A detailed feasibility assessment~     shows that there will be > 8197 eligible patients to meet the required enrollment of 3500.~   "
50857|NCT02901171|"~     The purpose of this study is to evaluate the efficacy of a smartphone application in~     enhancing Acceptance and Commitment Therapy group treatment for smoking cessation. This study~     also aims to elucidate the processes through which the treatment promotes smoking cessation~     and for whom it is most effective.~   "
50858|NCT02901158|"~     Esophageal pressure measurements are used in to determine chest wall elastance and calculate~     lung elastance and transpulmonary pressure in mechanically ventilated patients. A dedicated~     esophageal balloon catheter is then placed in the esophagus to measure tidal variations in~     esophageal pressure.~      In this study high resolution solid-state manometry technique was used to provide detailed~     and continuous measurements of esophageal pressures in the different parts of the esophagus.~     Measurements were performed during ongoing mechanical ventilation at different levels of~     endexpiratory pressure.~   "
50859|NCT02901145|"~     patients with progressive/relapsed solid tumors who failed first line therapy , will be~     treated biweekly with the anti PD1- Nivolumab. at least one month after treatment initiation~     low dose cyclophosphamide will be started .~      patients on trial will submit tissue and blood tests for whole exome an immune genomic~     signature. patients will also undergo repeated immunophenotype as part of follow up.~   "
50860|NCT02901132|"~     Malnutrition in oncologic patients has a negative impact on post- surgical recovery, survival~     and quality of life. The etiology of malnutrition in cancer patients is multifactorial,~     therefore, the nutritional assessment should be carried out by different parameters. The~     objective of this study is to investigate the association and prognostic value of five~     distinct methods of nutritional assessment (molecular, body composition, functional,~     anthropometric and subjective) in relation to postoperative complications and short-term~     survival in patients with cancer. Regarding the molecular parameter, mtor signaling pathwayon~     will be assessed in rectus muscle samples, harvested in the moment of the operation. Body~     composition was assessed by computed tomography (CT) and bioelectrical impedance test was~     conducted to evaluate the phase angle. Handgrip strength was used to determine functionality.~     The percentage of weight loss in relation to usual weight was the anthropometric parameter~     used. Subjective Global Assessment (SGA) was used to provide the nutritional diagnosis.~     Postoperative complications were classified according to the Dindo and Clavien~     classification. Overall time survival was the period between the first assessment of the~     patients until death or end of follow-up. Chi-square test, t test, Kaplan-Meier method and~     the Log Rank test and regression analysis will be used (p <0.05).~   "
50861|NCT02901119|"~     Malnutrition is prevalent among chronic liver disease patients. Inadequate ingestion and/or~     metabolic alterations modify the body composition and biological functions. The purpose of~     this study is to determine whether whey protein comsumption, due to amino acid profile,~     digestibility and bioactive compounds may be beneficial for patients waiting for liver~     transplantation~   "
50862|NCT02901106|"~     The dimethyl fumarate is an oral drug, indicated in the treatment of the relapsing-remitting~     multiple sclerosis (MS) , which efficacy and safety has been assessed and validated in two~     randomised, placebo phase-controlled III international studies, organized by the~     pharmaceutical company developing the molecule. TECFIDERA® (dimethyl-fumarate) has received~     European approval on January 30, 2014, for the treatment of adult patients with relapsing~     remitting MS.~      Treatment with dimethyl fumarate is introduced as part of the usual care under supervision of~     a physician experienced in the treatment of the disease.~      It has proved effective to reduce the number of relapses in patients with recurring-remitting~     MS and reduce the number of patients who have relapses during treatment.~      The objective of the study is to observe, in real conditions, on the one hand the tolerance~     and the other evolution, clinical and radiologic disease in patients already treated by~     dimethyl-fumarate and collect long-term safety data.~   "
50863|NCT02901093|"~     Sensorineural complications of stapes surgery are rare but potentially serious. Imaging is~     usually performed to identify an underlying cause, such as excessive intravestibular~     penetration of the prosthesis or pneumolabyrinth suggesting perilymphatic fistula.~      Unfortunately, there is very little data in an unselected series of uneventful patients.~      The aim of this study is to analyze the depth of prosthesis penetration within the vestibule~     and the rate of pneumolabyrinth the day or the day after the procedure by performing a Cone~     Beam CT (CBCT) of the temporal bone in a cohort of unselected patients, and to correlate~     imaging findings to clinical outcome. This prospective monocentric study is conducted in a~     tertiary referral medical center. A CBCT is performed in 80 consecutive patients having~     undergone stapes surgery for otosclerosis, the day or the day after the procedure.~     Penetration length and location of the prosthesis within the vestibule, as well as presence~     or absence of a pneumolabyrinth are recorded, and compared to clinical data (vertigo,~     nystagmus, hearing measurement).~   "
50864|NCT02901080|"~     This is a single-centre research study in patients seen within an NHS Improving Access to~     Psychological Interventions (IAPT) service with suspected generalised anxiety disorder (GAD).~     The study will involve 120 patients from the Leicestershire and Rutland area in England,~     United Kingdom.~      Participants will use the Alpha-Stim AID Cranial Electrotherapy Stimulations (CES) medical~     device, which is approved for use and proven to be safe and work for the treatment for~     anxiety, depression and insomnia.~      Participants will use the Alpha-Stim AID for 60 minutes every day for 6 or 12 weeks, either~     whilst on the waiting list for standard care treatment from IAPT, or in conjunction with~     standard care treatment from IAPT.~      The study will involve 6 study visits - one face-to-face at visit 1, followed by 5 visits via~     telephone at week 4, 6, 8, 12 and 24. At each visit, participants will be asked to complete~     questionnaires to assess anxiety, depression, sleep difficulty, quality of life and work and~     social functioning.~      The purpose of the study is to gather evidence for the clinical benefits and cost~     effectiveness of the Alpha-Stim AID when used in an NHS setting - how well does it work, and~     does it's use result in cost savings for the NHS.~      The study may show that the Alpha-Stim AID should be available on the NHS for patients with~     suspected GAD.~   "
50865|NCT02901067|"~     This is a phase II, pragmatic, prospective, randomized, double-blind, adaptive clinical trial~     examining the efficacy of statins and aspirin in the reduction of acute lung injury and~     venous thromboembolism in patients with fibrinolysis shutdown.~   "
50866|NCT02901054|"~     Serotonergic 5-HT3 receptors in the central nervous system are involved in pain processing~     after nerve injury. We are interested in learning if 5-HT3 receptor antagonist ondansetron~     might be an appropriate drug for treating pain after nerve injury (neuropathic pain), by~     investigating its bio-distribution in the cerebro-spinal fluid, and the genetic variability~     that may affect that distribution.~      Study procedures will include iv ondansetron administration, serial blood draws,~     cerebrospinal fluid (CSF) sampling, pregnancy testing, and possible ECG.~   "
50883|NCT02900833|"~     Clinical and experimental data suggest that neutrophil activation and extravasation are~     deleterious in acute ischemic stroke (AIS) involving an increased risk of unfavorable outcome~     and hemorrhagic transformation (HT). However, clinical trials targeting neutrophil~     recruitment in AIS patients were negative. Recently, an experimental study has shown that~     neutrophil activation and transmigration begin immediately after the occlusion. Inhibition of~     neutrophil recruitment several hours after the start of ischemia appears therefore too late~     to have a clinical relevance.~      The objective is to study the time dependent impact of neutrophils in AIS and the predominant~     mediators in each time point to identify the appropriate therapeutic target and time window.~   "
50915|NCT02900417|"~     The present study will recruit 9 newly diagnosed type 2 diabetic patient to receive~     sitagliptin 100mg daily for 12 weeks. The aim of this study was to investigate the~     composition of gut microbiota before and after the therapy of sitagliptin.~   "
50867|NCT02901041|"~     Alcoholism is the third leading cause of preventable death in the US, accounting for 80,000~     deaths annually. Almost 18 million US adults have alcohol use disorder (AUD); however,~     approved medications for the treatment of AUD has shown limited effectiveness.~      Zonisamide (ZON), a broad spectrum anticonvulsant, has proven to be more effective than a~     placebo in reducing alcohol intake in individuals with alcohol dependence. ZON's mechanism of~     action seems to be quite distinct from currently approved anti-alcoholism medications, which~     holds promise for treatment of individuals who are not responsive to conventional~     medications. However, much remains unknown about ZON's therapeutic mechanisms and ZON's~     efficacy in treating patients with a diagnosis of AUD.~      To fill in these gaps, the investigators will conduct a double-blind randomized controlled~     study that assesses ZON's treatment mechanisms and effectiveness in reducing alcohol~     consumption in patients with AUD. Participants will be randomized to one of two conditions:~     1) treatment with ZON and a computerized psychotherapy platform called Take Control (TC); 2)~     treatment with a placebo (PLC) and TC. To understand the neurobiology behind ZON's potential~     therapeutic effects on AUD, fMRI will be used to compare the brain activity of the ZON+TC~     versus PLC+TC group while participants perform an alcohol and emotional-word Stroop task, as~     well as an alcohol related cues task.~   "
50868|NCT02901028|"~     Significant morbidity, mortality, and related costs are caused by traumatic brain injury~     (TBI). A simple, effective, and lightweight device worn by athletes or war fighters in the~     field, designed to mitigate TBI resulting from blast trauma or concussive events, would save~     lives, and the huge costs currently being experienced for life-treatment of surviving~     victims. An externally-worn medical device that applies mild jugular compression according to~     the principle of the Queckenstedt Maneuver. PURPOSE: To monitor changes in vital signs, blood~     physiologies, oxygen consumption, biomechanics, strength, neurological capabilities, and~     balance in a population of athletes wearing the Device. Secondly, to determine the tolerance~     and acceptance of the Device while undergoing exertion.~   "
50869|NCT02901015|"~     Interventional, multicenter, and longitudinal study, of a cohort of patients with~     schizophrenia, evaluated on social cognition, neurocognition, symptoms, functioning with 12~     months interval.~   "
50870|NCT02901002|"~     In CRPS, perturbation of body image and pseudo-neglect syndrome of the body part affected are~     frequently found. Pain and sensory perturbation seems to modify the way patients perceived~     their body part affected.~      Does a local body image perturbation can affect the balanced of the global self-awareness?~   "
50871|NCT02900989|"~     The ASQ-Fr study aims at validating the French version of Ask Suicide-Screening Questions~     composed of 5 items in adolescents managed in pediatric emergency department. Therefore, use~     of this brief valid screening instrument could assess the risk for suicide in pediatric~     patients and then improve the prevention of suicidal tendencies in this population.~   "
50872|NCT02900976|"~     This pilot clinical trial studies how rituximab and latent membrane protein (LMP)-specific~     T-cells work in treating pediatric solid organ recipients with Epstein-Barr virus-positive,~     cluster of differentiation (CD)20-positive post-transplant lymphoproliferative disorder.~     Monoclonal antibodies, such as rituximab may block tumor growth in different ways by~     targeting certain cells. LMP-specific T-cells are special immune system cells trained to~     recognize proteins found on post-transplant lymphoproliferative disorder tumor cells if they~     are infected with Epstein-Barr virus. Giving rituximab and LMP-specific T-cells may be better~     in treating pediatric organ recipients with post-transplant lymphoproliferative disorder than~     rituximab alone.~   "
50873|NCT02900963|"~     Radiotherapy and chemotherapy are standard treatment of head and neck cancer alone or~     associated to surgical treatment. Early (during treatment or the following weeks) and late~     side effects contribute to malnutrition in this population at risk. In this context,~     nutritional support adapted by dietary monitoring and enteral nutrition (nasogastric tube or~     gastrostomy) are often necessary. The early identification of the patients with high~     malnutrition risk and requiring enteral nutrition is necessary to improve the tolerance and~     efficacy of treatment. This prospective study research the factors of malnutrition during~     head and neck radiotherapy.~   "
50874|NCT02900950|"~     A single-centre, randomised clinical trial of patients affected by periampullary cancer who~     underwent pancreaticoduodenectomies which included two different types of specimen~     margination: arm A (multicolour inking) and arm B (monocolour inking). The randomisation of~     the specimen was made after the resection, blinded for the surgeons involved in the~     operation. The primary endpoint was the overall R1 resection rate and its difference between~     the two arms. The secondary endpoints were the R1 resection rate in each margin and its~     difference between the two arms, and the impact of margin status on survival. A sample size~     of 18 patients was required.~   "
50875|NCT02900937|"~     The purpose of this study is to evaluate the safety and performance of a new version of a~     coronary artery stent for treating blockages in the arteries supplying blood to the heart~     muscle. The Amaranth Medical MAGNITUDE scaffold releases a drug (sirolimus) to reduce the~     likelihood of the treated blood vessel developing a new blockage. In addition, the scaffold~     dissolves away over time, leaving no permanent implant after the blood vessel has healed.~   "
50876|NCT02900924|"~     The MIMICS-3D study will evaluate safety, effectiveness and device performance within a~     real-world clinical population of patients undergoing femoropopliteal intervention.~   "
50877|NCT02900911|"~     Head and neck cancer has a negative impact in swallowing function and quality of life.~     Rehabilitation has proven its usefulness after radiation therapy (RT), but some studies~     suggest that interventions should be initiated prior to RT sessions. This study aims to~     evaluate the effects of prophylactic rehabilitation on swallowing and quality of life. The~     study pretends to establish a preventive rehabilitative program with the target of reducing~     RT side effects and improve patients' quality of life.~   "
50878|NCT02900898|"~     Rheumatoid arthritis (RA) is a chronic autoimmune disease with metabolic alterations due~     mainly by the liberation of catabolic cytokines leading to changes in body composition as~     rheumatoid cachexia. Dynamic exercise (DE) has demonstrated to improve muscular, strength and~     joint function as well as inflammatory process. Also, a diet focused on the consumption of~     certain fatty acids like the Mediterranean is recommended to reduce inflammation. The aim of~     this study is to assess the effect of a dynamic exercise program in combination with a~     Mediterranean diet in strength, joint mobility and disease activity in women with RA.~   "
50884|NCT02900820|"~     There is no evidence that discontinuing antibiotic therapy for non-bacterial infections is~     safe. The main objective of this study is to determine whether discontinuation of antibiotic~     therapy when a clinician no longer considers it necessary makes any difference in terms of~     the number of days with severe symptoms. This is a multicentre, open-label, randomised~     controlled clinical trial. The study will be conducted in ten primary care centres in Spain.~     We will include patients from 18 to 75 years of age with uncomplicated acute respiratory~     tract infections (RTIs) in whom: antibiotics are not necessary; or those diagnosed with~     clinical conditions for which antibiotics might be necessary but according to the history and~     clinical examination the physician considers that antibiotics are not needed or the patient~     feels that the antibiotic regimen has not worked as expected; or several doses of an~     antibiotic have been taken from leftovers found in the household or obtained at the pharmacy~     without any medical prescription for a clinical condition for which antibiotics are not~     necessary. The patients will be randomly assigned to the usual strategy of continuing~     antibiotic treatment (usual intervention group) or discontinuing antibiotic therapy (novel~     intervention group). A sample size of 215 patients per group was calculated on the basis of a~     reduction of one day in the duration of severe symptoms as a clinically relevant outcome. The~     primary outcome will be duration of severe symptoms, i.e. symptoms scored 5 or 6 by means of~     a symptom diary. Secondary outcomes will include: antibiotics taken, adverse events, patient~     satisfaction, and complications within the first 3 months.~   "
50885|NCT02900807|"~     Oro-tracheal intubation is performed daily in anesthesia and in the ICU. When a patient is~     intubated, the endotracheal tube must be inserted into the trachea to the right depth. If the~     tube is not deep Inserted enough there is a risk of accidental extubation and trauma to the~     vocal cords by the balloon. If the tube is inserted too far there is a risk of selective~     intubation into the right or left mainstem bronchus, which can lead to contralateral lung~     atelectasis and hypoxemia.~      The purpose of this study is to determine whether there is a correlation between the~     measurement of the airway of an adult population and criteria that would be easily accessible~     in daily clinical practice: the height of the patient and the size of their feet.~   "
50886|NCT02900794|"~     Sinusitis is a common medical problem, which significantly decreases patients' quality of~     life (QOL). Patients may have symptoms such as headaches, sinus pressure, nasal congestion~     and drainage, decreased sense of smell, and malaise. Surgical therapy for sinusitis attempts~     to restore the sinus health by directly relieving sinus obstruction. Small telescopes, called~     endoscopes, are placed through the nostrils into the nasal cavity to enhance visualization,~     illumination, and magnification of the sinuses and adjacent structures. There are a variety~     of surgical instruments available to a surgeon for ESS such as stainless steel tools~     (shavers, microdebriders, or grasping tools) to address sinusitis. Surgical therapy has been~     shown to improve QOL, decrease medication use and days missed at work for subjects. The use~     of lasers in treatment of chronic sinus infections is well documented. The LF-40 Gold Laser~     (Medical Energy, Inc.; Pensacola, FL) has already been approved for clinical use in various~     procedures including tonsillectomy, adenoidectomy, tracheal stenosis (narrowing),~     post-intubation granuloma, recurrent respiratory papilloma, and microtia (an underdeveloped~     ear), and sinus surgery. In this study, the investigators plan to utilize the Gold laser for~     1) excision of the concha bullosa, 2) maxillary antrostomy, and 3) submucosal cauterization~     of the turbinates and compare postoperative outcomes with the use of a microdebrider. These~     uses are under the approved indication for the LF 40 Gold Laser1, 2, 3. The follow-up times~     are as follows: 2 weeks postoperatively, 2 months postoperatively, 6 months postoperatively.~   "
50887|NCT02900781|"~     Partial or Total Knee Arthroplasty are procedures commonly used in severe degeneration of the~     knee joint due to osteoarthritis. With an increasing number of Partial or Total Knee~     Arthroplasty performed in a population that is aging during a time where the amount of~     healthcare dollars allotted to rehabilitation is declining, there is a need to develop remote~     monitoring of rehabilitation and to engage and optimize self-management of recovery.~      Current management of Partial or Total Knee Arthroplasty recovery is typically performed in~     the out-patient setting and is highly protocol driven. A typical case might be seen by the~     physical therapist 2-3x/week for 8-10 weeks to perform specific exercises and to monitor~     progress (i.e. compliance with ROM and strengthening exercises). One recent study suggested~     that variation in patients' independent exercise and activity after arthroplasty surgery may~     contribute to variable functional gains.~      The investigators are proposing that the StepRite device developed by MedHab, (a shoe insert~     that collects functional data) will reduce cost and improve the efficacy of rehabilitation in~     total knee arthroplasty patients~   "
50888|NCT02900768|"~     Although allogeneic haematopoietic stem cell transplant (AlloHSCT) is a curative treatment~     option for malignant hematological diseases, it is also associated with significant morbidity~     such as graft versus host disease, infections, and immune complications. Moreover, long-term~     survivors are likely to have reduced physical performance and functioning due to~     deconditioning, sarcopenia, and bone loss, and particularly high levels of fatigue and~     psycho-social stress, all of which negatively impact patients' quality of life.~      Purpose: To conduct a randomized controlled, single site trial investigating whether a~     partially supervised exercise intervention in the first 100 days post alloHSCT patients will~     result in improved quality of life at Day 100 post-transplant compared to standard of care~     treatment. Secondary objectives will investigate the effect of an exercise intervention on~     muscle strength, cardiorespiratory fitness, mobility, bone mineral density, body composition,~     exercise, and immunological/inflammatory biomarkers compared to standard of care.~      Procedure: 120 patients receiving alloHSCT will be baseline tested, and then randomized into~     an Exercise Intervention Group or Standard of Care Control Group.~   "
50889|NCT02900755|"~     Perampanel, a novel AED, has been recently authorized in Korea and worldwide as a treatment~     of refractory partial-onset seizures with a new anti-epileptic mechanism of a selective~     non-competitive antagonist of AMPA receptors.~      Evaluating adverse effects during the introduction of new AED is often difficult since the~     complaints are subjective and objective assessment is complicated due to the polytherapy.~     Majority of previous studies are focused on quantitative analysis of EEG for taking new AEDs~     because of the correlation of EEG analysis results and side effects of AED such as cognitive~     slowing. Therefore, this study aims to investigate the effects of perampanel on EEG in terms~     of EEG background spectra and to evaluate perampanel effects by using subjective~     questionnaires assessing depression, anxiety, sleep quality and fatigue.~   "
50890|NCT02900742|"~     The investigators performed a randomized, prospective study method on observation of~     Traditional Chinese Medicine(TCM) combined with chemotherapy maintenance to prolong the~     efficacy of long-term survival of advanced non small cell lung cancer(NSCLC) patients.The~     investigators plan to involve 100 cases for observation in 3 years (50 cases for chemotherapy~     maintenance, 50 cases for chemotherapy maintenance plus TCM), expecting that integrated TCM~     combined with chemotherapy maintenance has a better efficacy on prolonging progression-free~     survival time, overall survival, improving quality of life(QOL) of patients than that of~     chemotherapy maintenance.~   "
50891|NCT02900729|"~     Hypertension represents a significant global public health problem, contributing to vascular~     and renal morbidity, cardiovascular mortality, and economic burden. For a mostly asymptomatic~     disease, there is a huge challenge to maintain a good adherence and longtime persistence of~     drug use so as to adequately control it. Even so, a significant proportion of patients will~     develop resistant hypertension. In recent years, renal denervation has been argued as an~     effective means to address blood pressure problem in several non-Chinese clinical trials. The~     technique is to deliver low level radiofrequency energy through the renal artery wall to~     target the sympathetic nervous system and then modulate blood pressure.~      Shanghai WiseGain Medical Devices Co., LTD has developed the WiseGo Catheter System, which is~     an irrigated radiofrequency ablation Catheter. With this Catheter, it is expected to improve~     blood pressure status among patients with resistant hypertension failing polypharmacy. The~     purpose of this randomized control trial is to obtain an assessment of the efficacy and~     safety of WiseGo renal denervation technique in the presence of three standard~     antihypertensive medications in Chinese patients.~   "
50892|NCT02900716|"~     This study will evaluate the safety, antitumor activity and preliminary pharmacokinetics of~     an investigational drug product, DTRMWXHS-12, in patients with chronic lymphocytic leukemia~     or other B-cell lymphomas. DTRMWXHS-12 will be evaluated as a single agent, and in~     combination.~      This study will be conducted in two parts: phase Ia and Ib. Both parts will explore~     escalating doses of DTRMWXHS-12. The phase Ia study will evaluate DTRMWXHS-12 monotherapy.~     The phase Ib study will evaluate DTRMWXHS-12 combinations.~   "
50893|NCT02900703|"~     -  Epidemiological studies have shown the diversity of resistance genotypes and the~          evolution of their prevalence in the paediatric population. This large study conducted~          in a context of very low vaccination coverage will generate more precise data on the~          natural epidemiological evolution of rotavirus, notably the G9 genotype, which has~          appeared relatively recently.~        -  This study will allow us to identify and document rare or unusual strains of human or~          animal origin. The complete genetic characterization of these strains will also make it~          possible to study their ability to recombine and to assess the risk of emergence. Among~          these still rare strains, the investigators are particularly monitoring G12 rotavirus,~          whose ability to recombine raises the risk of emergence.~        -  For at least one of the centres taking part in the study, the paediatric population~          studied will be given strong vaccination coverage. It will be extremely interesting to~          compare the results obtained in the vaccinated population with non-vaccinated children~          to assess the impact of this vaccination on the distribution of rotavirus genotypes~   "
50894|NCT02900690|"~     The main objective of this project is to assess the average cost of the treatment of bleeding~     postpartum with recombinant activated factor VII (NovoSeven®) and compare it to the reference~     strategy. Costs related to medicine NovoSeven® can generate surplus, but it also avoids in~     some cases very costly invasive procedures. It will be interesting to compare the average~     cost of the complete strategies supported.~   "
50895|NCT02900677|"~     The aims of this three-year study are to:~        1. explore the change of fatigue, nutritional status, quality of life and care needs in~          patients with operable pancreatic cancer perioperatively and following surgery within 3~          months.~        2. develop and evaluate the effect of patient-centered cancer prehabilitation care program~          on improving fatigue, nutritional status and quality of life (QOL) in this population.~   "
50896|NCT02900664|"~     The purpose of this study is to combine the PDR001 checkpoint inhibitor with each of four~     agents with immunomodulatory activity to identify the doses and schedule for combination~     therapy and to preliminarily assess the safety, tolerability, pharmacological and clinical~     activity of these combinations.~   "
50897|NCT02900651|"~     The purpose of this Phase I/II study is to establish the maximum tolerated dose (MTD) and/or~     recommended phase 2 dose (RP2D) and to evaluate the safety, antitumor activity and~     pharmacokinetic (PK) profile of MAK683 in patients with advanced malignancies such as Diffuse~     Large B cell Lymphoma (DLBCL), nasopharyngeal carcinoma (NPC) or other advanced solid tumors~     for whom no further effective standard treatment is available.~   "
50898|NCT02900638|"~     The purpose of this study is to determine whether mentoring is associated with beneficial~     cardiovascular health effects in both mentors and mentees.~   "
50899|NCT02900625|"~     Cryopreservation of ovarian tissue is offered to young girls and women aged under 35 who have~     to undergo sterilizing gonadotoxic treatment, with the aim of preserving their fertility. The~     main part of the ovary is preserved, as primordial and primary follicles are resistant to~     freezing / thawing protocols. In the absence of other techniques (in vivo maturation,~     injecting isolated ovarian follicles, etc.) autografting this cryopreserved tissue is~     currently the only technique allowing fertility to be restored. Autograft is possible only if~     the indication for ovary cryopreservation is a non-neoplastic pathology or a malignant~     pathology with a low risk of ovarian metastasis. In other cases of neoplastic pathologies,~     particularly in cases of acute leukemia, tissue cannot as yet be re-used due to the lack of~     any codified technique for evaluating residual disease (MRD). The team has for two years been~     developing and validating a technique to look for residual disease in fragments of ovarian~     cortex in cases of acute leukemia. This technique is based on an original protocol for~     dissociating ovarian tissue to obtain a population of isolated ovarian cells that may be~     analyzed by multicolor flow cytometry. The specificity and sensitivity of the technique have~     been demonstrated in an experimental model. This model consists in using 8 color flow~     cytometry to look for characterizable leukemia cells added in different dilutions to a~     population of isolated ovarian cells taken from model ovarian cortex and up to a dilution of~     10-5. When the molecular markers were present on diagnosis, they were found by RQ-PCR with~     the same dilutions. The model tissue came from laparoscopic ovarian drilling in patients with~     polycystic ovary syndrome. The main objective of this project is to validate techniques that~     have been previously codified with different populations of leukemia cells that may be~     characterized. The investigators then aim to adapt and validate this technique to look for~     MRD using 8 color flow cytometry on cryopreserved fragments of ovarian cortex from leukemia~     patients that are at risk of metastasis. Secondary objectives will be to implement procedures~     for oncological qualification of grafts in cases of malignant pathology and to consider the~     recommendations for using this cryopreserved ovarian tissue through the autograft technique~     for these indications.~   "
50900|NCT02900612|"~     This study aims to compare the effects of two water-based training models in physiological~     parameters of dyslipidemic elderly women. Thus, a randomized controlled clinical trial will~     be conducted in parallel with the participation of 45 dyslipidemic elderly women.~   "
50901|NCT02900599|"~     Much of HIV is related to behaviour: sexual risk taking, late diagnosis, adherence to~     antiretroviral therapy, follow up, disclosure of one's HIV status. The project aimed to use~     various psychometric tools to determine if these scores have a predictive value on late~     testing, treatment succes, quality of follow up, and disclosure of HIV to sex partners. The~     expected outcomes would be to be able to stratify patients using a behavioural risk score and~     allocate targeted ressources to improve the quality of care for the most at risk patients.~   "
50902|NCT02900586|"~     The purpose of this study is to contribute to the evaluation of SIOUX study by adding data~     about the choices of the observant patients, the mis-observant ones or the protocol~     deviations.~   "
50903|NCT02900573|"~     Withdrawing artificial nutrition in palliative care is an issue that often leads to ethical~     dilemmas among health care providers, despite clinical guidelines.~   "
50904|NCT02900560|"~     The purpose of the study is to determine the optimal dose of CC-486 (oral azacitidine) in~     combination with pembrolizumab for the treatment of platinum-resistant/refractory Epithelial~     Ovarian Cancer (EOC).~   "
50905|NCT02900547|"~     The PREMEDIC is a prospective, observational study. Patients hospitalized for Systolic Heart~     Failure will be enrolled and health data will be collected at hospital admission and during~     hospital stay. No data will be collected before detailed information is given to the patient~     and a non-opposition is obtained.~      The aim of this observational and prospective study is to evaluate the concordance actual~     patient management during the in hospital treatment of heart failure and the therapeutic~     proposals from a medical algorithmic decision support software.~   "
50906|NCT02900534|"~     The purpose of this study is to evaluate the efficacy of an internet-based self-help~     intervention for older adults with prolonged grief symptoms after spousal bereavement or~     separation/divorce. The study design is a randomized trial with a waiting control condition~     of 12 weeks and a follow-up after 6 months. The investigators will test the following main~     hypotheses:~        1. The intervention group shows a significant decrease in grief symptoms, psychological~          distress, depression symptoms and embitterment, and a significant increase in life~          satisfaction, as well as session related outcomes from baseline to 12 weeks post~          intervention assessment.~        2. The effects in the intervention group are larger than the effects in the waiting control~          group.~        3. These effects are stable from the post measure at 12 weeks to the 6-month follow-up.~   "
50907|NCT02900521|"~     The registry is the main objective exhaustive list of cases validated stroke brain on a~     geographical area defined to calculate an incidence.~   "
50908|NCT02900508|"~     The purpose of this study was to investigate the effects of virtual reality-base training for~     cerebellar ataxia.~   "
50909|NCT02900495|"~     Children referred to the pediatric urology clinic for primary nocturnal enuresis will be~     screened for enrollment. Patients who fail behavioral therapy and who meet inclusion criteria~     will be offered therapy with a TENS unit.~      Patients will be randomized into four groups. Group 1 will be the direct bladder stimulation~     arm with electrodes placed onto the abdomen in the suprapubic region directly over the~     bladder. Group 2 will be the distal neural loop arm with electrodes placed over the posterior~     tibial nerve. Group 3 will be the proximal neural loop arm with electrodes placed about 2-3~     cm lateral to the midline in the sacral region at the level of S3. Group 4 will be the~     control arm with electrodes placed on the scapula. We will aim to recruit 32 patients per~     group for a total of 128 patients. The patients will be provided with a TENS unit (TENS 3000~     Analog) and electrode pads and caretakers instructed on how to use the apparatus.~      The TENS sessions will be performed nightly before bed for 20 minutes. TENS units will be set~     at a frequency of 10 Hz, and intensity determined by the sensitivity threshold of the~     patient. Diaries including nighttime incontinence episodes and a wet sheet scale (dry,~     damp, wet, soaked) will be recorded, along with any adverse reactions to the TENS unit.~     Patients will be followed up after one month of TENS with evaluation including the Pediatric~     Urinary Incontinence Questionnaire, a validated tool for measuring quality of life in~     children with bladder dysfunction; this questionnaire will be filled out prior to starting~     TENS treatment in order to compare the effect of treatment on QOL. . They will then follow up~     on these parameters again after another month (one month off of TENS therapy) to assess the~     durability of treatment effect. The data will be collected at different time points~     (baseline, 1 month, 2 months) for each group by itself and the groups compared against each~     other using statistical analysis.~   "
50910|NCT02900482|"~     The main objective is to identify the genes involved in congenital dislocation of the hip.~      The secondary objectives are to measure the association between mechanical risk factors and~     congenital dislocation of hip and study the interactions between these factors and genetic~     factors.~   "
50911|NCT02900469|"~     The purpose of this study is to determine whether one dose of denosumab can lead to changes~     in the tumor, which may decrease the ability of tumor to spread.~   "
50912|NCT02900456|"~     Intra-aortic Balloon Pumps (IABP) have been used for roughly 50 years in Critical Care Units,~     Intensive Care Units, Cath labs as a way to improve systemic and coronary circulation in~     patients in cardiogenic shock (CS) or at high risk situation as mechanical complications~     stemming from myocardial infarction (MI), critical coronary stenosis, high-risk PCI, etc.~     Several papers recently questioned the relevance of this assistance device - namely the~     IABP-SHOCK II trial in CS and the CRISP-AMI trial in anterior MI without CS - resulting in~     the downgrading of the recommendation standards of the IABP by medical societies.~   "
50913|NCT02900443|"~     Rationale: Current standard therapy of autoimmune hepatitis consists of a combination of~     prednisolone and azathioprine. However, a significant proportion of patients does not respond~     to, or is intolerant for, azathioprine. Mycophenolate mofetil (MMF) has surpassed~     azathioprine as therapy to prevent organ transplant rejection and is sometimes used as an~     alternative option for autoimmune hepatitis. Several case series and one prospective study~     have documented the efficacy and safety of mycophenolate mofetil as induction therapy for~     autoimmune hepatitis. Robust evidence from a formal randomized clinical trial is lacking.~      Objective: To assess the efficacy and safety of mycophenolate mofetil as induction therapy in~     patients with treatment naive autoimmune hepatitis.~      Study design: Multicenter, randomised, open-label intervention study Study population:~     Patients with newly diagnosed autoimmune hepatitis who are in need of induction therapy~     according to current guidelines.~      Intervention: The intervention group will receive oral mycophenolate mofetil for 24 weeks.~     The control group will be treated with azathioprine for 24 weeks. Both groups will be treated~     with steroid induction which will closely follow the schedule from the recent Clinical~     Practice Guidelines by the European Association for Study of the Liver (EASL).~      Main study parameters/endpoints: The primary outcome is the proportion of patients in~     remission, defined as normalization of serum alanine transaminase (ALT) and immunoglobulin G~     (IgG) levels after 24 weeks of treatment, per treatment group. Secondary endpoints include~     safety and tolerability of mycophenolate mofetil, time to remission, changes in Model For~     End-Stage Liver Disease (MELD) -score (and its components bilirubin, INR, creatinine),~     albumin, pseudocholinesterase and N-terminal procollagen-III-peptide, ELF (Enhanced Liver~     Fibrosis) -score and aspects of quality of life. In a sub-study, drug levels will be~     measured.~   "
50914|NCT02900430|"~     Patients with acute myeloid leukemia (AML) are at risk to develop severe infections whose~     invasive aspergillosis (IA). These infections are leading to an important morbidity and~     mortality. Antifungal prophylaxis is recommended by posaconazole for AML patients during~     neutropenia induced by induction chemotherapy. Their application is not uniform.~   "
50916|NCT02900404|"~     This study shall determine whether XAPPORT - a mobile device app based on different~     guidelines, the summary of product characteristics of rivaroxaban, and clinical facts and~     practice - provides adequate guidance to physicians attending patients undergoing elective~     surgery, who have to interrupt treatment with rivaroxaban for surgery, in deciding how to~     approach the pre- and postoperative management of anticoagulation.~   "
50917|NCT02900391|"~     Elderly population is increasing quickly and their need for health care ressources through~     emergency care is also growing. While these patients are ageing physical impairment often~     happens along the way. Apart from senior homes, different types and levels of home care~     services have been developped in order to overcome or to adapt to these situations.~      Our goals are:~        -  to assess mortality rate depending on home care services level for the elderly~          population consulting in the ED or being taken in charge by the Emergency Medical System~          in France.~        -  to describe this population in terms of autonomy, impairment and home care services~   "
50918|NCT02900378|"~     The purpose of this randomized, actively controlled, double-blind study is to demonstrate the~     superiority of sacubitril/valsartan over enalapril in increasing non-sedentary physical~     activity chronic heart failure patients with reduced ejection fraction. Physical activity~     will be continuously measured by means of a wrist-worn accelerometry device from 2 weeks~     before until 12 weeks after start of study therapy (sacubitril/valsartan or enalapril).~   "
50919|NCT02900365|"~     In a randomized clinical trial, 30 eyes with traumatic cataract after open globe injury with~     IOL implantation underwent early and 30 eyes underwent late cataract surgery. We excluded~     patients who were under 12-year-old. All patients were visited at 1week, 4 weeks , 12 weeks~     and six months after surgery. In each visit, patients were examined regarding visual acuity,~     intraocular pressure (IOP), anterior chamber inflammation, IOL position and posterior~     synechiae. In addition, posterior segment evaluation and funduscopy were performed.~     Intraoperative complication including posterior capsular rupture, anterior vitrectomy and~     zonulysis as well as the site of IOL implantation were documented and postoperative~     complications including raised IOP, anterior chamber inflammation, visual axis opacity,~     posterior synechiae, subluxation of IOL, IOL pigment deposition were listed.~   "
50920|NCT02900352|"~     This is a randomized, placebo-controlled, double-blind, 16 week trial of the medication~     zonisamide for the treatment of heavy drinking alcoholic civilians.~   "
50921|NCT02900339|"~     Magnetic resonance imaging (MRI) is a noninvasive and non-ionizing (no use of X-rays) imaging~     modality. Today it is considered an anatomical and functional exploration reference~     technique. Since its inception around 1985, this technology is constantly evolving.~      Many advances in MRI require constant adaptations of radiological practices. The~     morphological image is now associated with functional and parametric information (infusion,~     diffusion spectroscopy, etc ...). In parallel, work combining acquisition and post-processing~     of data also open new applications (tractography, functional MRI, etc ....). Thus, more and~     more procedures are necessary to integrate these techniques for the diagnosis and adapt to~     new demands of clinicians.~      The type of sequence and its associated parameters allow to directly influence the contrast~     of images, to characterize tissue compared to another and, ultimately, to highlight~     morphological or functional abnormality. Image quality can be optimized on each MRI,~     depending on the time available for the acquisition on the one hand, and on the desired~     resolution and contrast, on the other hand. For each sequence, it is therefore necessary to~     find a compromise that will optimize the diagnostic quality of the examination.~      This optimization requires a phase focusing on healthy volunteers. It is therefore important~     that researchers and physicists could design on healthy volunteers, the best settings of all~     parameters for an image or spectrum. Indeed, it is always necessary to properly optimize~     every parameter choices before beginning a study of a cohort of patients.~      In this context, the main objective of this study is to optimize sequences and imaging~     protocols to evaluate and validate the choice of parameters in healthy volunteers.~   "
50922|NCT02900326|"~     Integrative approaches to promote wellness and reduce the distress associated with cancer are~     considered as essential components of cancer care. In case, exercise training has been shown~     to produce many positive physiological and psychological benefits. Mindfulness-based stress~     reduction program shows similar beneficial effects, and especially in emotional distress~     management. The aim of the study is to examine the cumulative effect of an 8~     week-exercise-training program combined with an MBSR program on cardio-respiratory fitness~     and quality of life in women with breast cancer. These effects are thought to be mediated in~     part through changes in underlying brain processes, that investigators will be put in light.~     Through telomerase activity, oxidative stress, mitochondrial respiration and blood cytokine~     level measurements, investigators could expect to better understand the effect of these~     combined training in breast cancer.~   "
50923|NCT02900313|"~     Cardiac surgery associated acute kidney injury is an independent factor of morbidity and~     mortality . Despite its delayed elevation, serum creatinine (Cr) remains the goal standard to~     diagnose AKI. Hyperphosphatemia is well-know in case of AKI because of its excretion~     decrease. Moreover, serum phosphorus (Ph) is daily measure d after cardiac surgery since its~     variation may lead to cardiac dysfunction. In case of AKI, Ph may reflect the decrease of~     renal function in this context. Consequently, the purpose of this study is to evaluate the~     predictibility of Ph to detect both AKI induction and in a second time, renal recovery.~   "
50924|NCT02900300|"~     The first aim of the study is to obtain from chirurgical micro biopsy myoblast in culture~     which will differentiate in Diaphragm fiber. Then these fibers will be submitted under~     mechanical stress condition similar to those imposed in vivo by mechanical ventilation to~     validate in human a model in vitro of diaphragm dysfunction induced by mechanical~     ventilation. Then the second part of the study will be to evaluate with this model, the~     efficiency of an antioxidant therapy.~   "
50925|NCT02900287|"~     Cancer survival is important to determine prognostic of patients and evaluate care and~     prevention health strategies. Sucre is the first study to describe cancer survival in Reunion~     Island. Sucre aims at evaluating five year cancer prognostic in Reunion Island by cancer site~     and gender. Sucre is a retrospective cohort study of cancer diagnosed between 01/01/1998 and~     31/12/2008.~   "
51453|NCT02893410|"~     Patients treated with oral or sub-cutaneous drugs for polycythemia vera or essential~     thrombocythemia completed an unique paper questionnaire in order to describe their~     observance, the side effects and their own appreciation of the taken drug.~   "
50926|NCT02900274|"~     The aim of the study is to assess the safety and efficacy of the Multi-LOC® peripheral stent~     system to treat de novo and restenotic lesions (no in-stent restenosis (ISR), no restenosis~     post drug coated balloon (DCB) after flow limiting plain old balloon angioplasty (POBA)~     and/or DCB dilatations in the superficial femoral artery (SFA) and popliteal segments (P1, P2~     & P3)~   "
50927|NCT02900261|"~     This study will compare different methods (24 hour urine collection, evening and morning~     spots, and questionnaires) to measure the consumption of sodium and cafeine in children and~     adolescents.~   "
50928|NCT02900248|"~     Registry participants with advanced malignancy or myelodysplasia will have a sample of their~     tumor or tissue analysed for genetic alterations using next generation sequencing (NGS)~     performed in a lab that has been certified to meet a high quality standard. Treatments and~     outcomes will be reported to the registry to allow further understanding of how genetic~     differences can lead to better diagnosis and treatments.~   "
50929|NCT02900235|"~     The purpose of this study is to investigate the absorption, metabolism and excretion of~     MT-3995 in healthy subjects.~   "
50930|NCT02900222|"~     The purpose of this study is to determine whether endoscopic choroid plexus coagulation is~     safe in adult patients with communicating hydrocephalus and risk factors for complications~     from the standard surgical treatment. It may also help determine whether the endoscopic~     choroid plexus coagulation is effective in treating your communicating hydrocephalus. The~     Investigators hope that this research will allow us to place fewer shunts in patients with~     conditions similar to yours, avoiding complications.~   "
50931|NCT02900209|"~     The aim of this study is to determine responses of the immune system to the annual flu~     vaccination in people with COPD who experience frequent or infrequent exacerbations and~     healthy participants. We will collect blood and saliva immediately before and one month after~     flu vaccination at GP surgeries in the Autumn/Winter period. By measuring how quickly~     antibodies (that provide protection against infection) develop in the blood after vaccination~     we can provide important new information to help confirm whether those prone to COPD flare~     ups have weaker immune systems.~   "
50932|NCT02900196|"~     The purpose of this clinical study is to evaluate the effect of a four-week consumption of a~     fresh fermented dairy drink containing probiotic strains on Antibiotic-Associated Diarrhea~     and Gastro-Intestinal disorders in adult subjects treated for Helicobacter pylori~     eradication.~   "
50933|NCT02900183|"~     Patients with Alpha-1 Antitrypsin Deficiency (AATD) will be enrolled to receive multiple~     doses of ARC-AAT Injection. All subjects will require a pre-dose biopsy and a biopsy post~     last dose.~   "
50934|NCT02900170|"~     Anticoagulation-Related Nephropathy (ARN) is a side effect of treatment with blood thinners~     which leads to kidney dysfunction. A recent review suggests that kidney function should be~     assessed (by measuring serum creatinine) serially in the first few months of starting a blood~     thinner. ARN is diagnosed when there is a decline in kidney function after starting the blood~     thinner and other possible causes of this decline have been excluded. ARN has mainly been~     studied in relation to the common blood thinner - warfarin, where the prevalence is variable~     but can be as high as 37% (approximately 1 in 3) in the patients at highest risk. The risk~     factors that make this side effect more likely include the presence of pre-existing kidney~     disease, high blood pressure, older age and diabetes mellitus. Studies have shown that the~     occurence of ARN can lead to an accelerated progression of pre-existing kidney disease and a~     65% increase in the risk of death (mortality).~      The non-vitamin K oral anticoagulants (NOACs) are a new group of drugs which have been~     recently approved for use as blood thinners. They have a faster onset of action compared to~     warfarin and unlike warfarin, they do not need frequent monitoring. Rivaroxaban is the most~     commonly prescribed NOAC at Einstein Medical Center Philadelphia. There are some case reports~     that other NOACs (such as dabigatran and apixaban) can lead to ARN, however there is no study~     that has determined the true incidence of ARN in NOACs. Our study is designed to find out the~     incidence of ARN in patients who are started on rivaroxaban.~      The investigators intend to serially monitor the kidney function of 40 high risk patients who~     are recently started on rivaroxaban over a six month period. This will enable us to discover~     how many patients actually develop ARN after starting a NOAC. The information the~     investigators will obtain from this study will enable patients and health care providers make~     better decisions about using blood thinners. If the investigators find that the incidence of~     ARN with rivaroxaban is less common than that previously reported with warfarin, it can~     potentially make more patients use the NOACs and hence save them from the morbidity and~     mortality associated with ARN. Our study is unique because this will be the first study~     focused on ARN in one of the new blood thinners. The information the investigators get from~     this study will be a very important foundation for future studies.~   "
50935|NCT02900157|"~     This is an open-label, study of MEDI9090 to evaluate the safety, tolerability, PK,~     immunogenicity, and antitumor activity of MEDI9090 in adult subjects with advanced solid~     tumors.~   "
50936|NCT02900144|"~     The main purpose of this trial is to develop and investigate the effects of a modified~     comprehensive behavioral intervention for tics (CBIT) protocol for children and adolescents~     with chronic tic disorders and ADHD.~      CBIT is a first-line behavioral treatment for individuals with tic disorders. However, the~     benefit of CBIT is mitigated in those with co-occurring ADHD, as ADHD is negatively~     associated with effect size in behavioral treatments for tics. Additionally, while tic~     disorders are associated with reduced quality of life measures, CBIT is 'tic-specific.'~     Despite improving tics, measures do not show associated improved quality of life. Currently,~     there are no standardized behavioral treatments for tics that account for ADHD symptoms~     and/or addresses the impact that tics and ADHD symptoms have on quality of life.~      The first aim is to develop a treatment protocol that combines elements from CBIT, Cognitive~     Behavioral Therapy (CBT) for ADHD and factors targeting psychosocial impairment.~      The second aim is to determine the treatment feasibility and acceptability (e.g. retention,~     reasons for treatment refusal and dropout, and motivation) of this modified CBIT treatment.~     The investigators will evaluate and assess the randomization process, the treatment modules,~     and the expectations and satisfaction of the participants and their parents.~      The final aim is to use a pilot randomized control trial (RCT) design to evaluate improvement~     using measures including tic, ADHD and quality of life scales as rated by a blinded~     clinician. Though the investigators will evaluate efficacy of the modified protocol, the~     primary purpose will remain feasibility. The hope is to use this study to develop larger~     trials in the future.~   "
50937|NCT02900131|"~     Atopic Dermatitis is a chronic relapsing eczematous skin disease with increasing prevalence.~     Complementary and alternative medical approaches have been employed to relieve symptoms of~     Atopic Dermatitis. We aim to establish basic clinical efficacy and safety data for Jaungo in~     patients with Atopic Dermatitis.~   "
51055|NCT02898584|"~     The purpose of this research study is to test the feasibility, acceptability, and preliminary~     effectiveness of the use of a mobile pharmacist-led intervention that incorporates home BP~     monitoring and medication reminders with patients recruited from a primary care setting, as~     well as identify challenges and potential solutions to broader implementation of a mobile~     pharmacist-led home-based BP monitoring intervention in primary care clinics through key~     stakeholder interviews.~   "
50938|NCT02900118|"~     Breast cancers are among the cancers that metastasize the most to the skeleton. The~     appearance of bone metastasis, whether they are initials or during a relapse, is a turning~     point of the disease, due to the additional morbidity they imply (pain, pathologic fractures,~     hypercalcaemia, neurological compression, etc.). A specific treatment of these metastasis is~     often undertaken, usually a chemotherapy or hormone therapy. It is important to evaluate the~     efficacy of this treatment in order to know whether to continue or change it depending on the~     response observed. But there is no consensus at this time on paraclinical examinations~     enabling this monitoring. Also, if some criteria for assessing bone metastasis in imaging and~     nuclear medicine (MDA, PERCIST, EORTC) have been published in the literature, none is~     formally validated and evaluation in routine practice remains subjective.~      The main objective of our study is to determine if the PET-CT and the whole-body MRI are in~     agreement on the status of bone metastasis (stability, progression, partial response,~     complete response).~   "
50939|NCT02900105|"~     The investigators hope to learn if Letrozole is effective and safe in improving severe male~     infertility by increasing testosterone, decreasing oestradiol and stimulating sperm~     production thereby improving sperm motility (movement) and concentration. The study is being~     conducted because Letrozole is not yet proven to be a standard treatment in subjects with~     absent or very low sperm counts. The investigators are hoping to determine whether Letrozole~     is equal or superior to no treatment.~   "
50940|NCT02900092|"~     Major depressive disorder (MDD) is highly prevalent and nearly 70% of individuals with MDD do~     not respond to standard antidepressant therapies despite adequate dosing. An effective and~     well-tolerated antidepressant augmentation therapy would have important clinical and public~     health implications. Neuroactive steroid hormones are known to directly activate~     neurotransmitter receptors in the brain, and thus are potential candidates for augmentation~     therapies to enhance the effect of traditional antidepressants. The investigators hypothesize~     that administration of an allopregnanolone analog in women with treatment-resistant~     depression will improve depressive symptoms.~   "
50941|NCT02900079|"~     This study is part of a larger prospective cohort study (JOKA), designed to study the~     incidence and etiological spectrum of febrile illness occurring during a travel to the~     tropics, as well as clinical course, care, treatment and outcome of these febrile illness~     episodes. Its objective is to evaluate the clinical use of malaria rapid diagnostic tests~     (RDT) by travelers or their peers during travel, as a decision aid for the management of~     febrile illness in the tropics.~      If the study demonstrates that malaria can be ruled out safely by travelers themselves using~     a RDT, a combination of self/peer testing with SBET may become an alternative to antimalarial~     chemoprophylaxis in travel medicine.~   "
50942|NCT02900066|"~     This study is part of a larger prospective cohort study (JOKA), designed to study febrile~     illness occurring during a travel to the tropics, as well as the evaluation of the clinical~     use of malaria rapid diagnostic tests (RDT) by travelers or their peers during travel, as a~     decision aid for the management of febrile illness in the tropics.~      Filter paper blood spots and paired serology are used in addition to routine post-travel~     evaluation, to study the incidence and etiological spectrum of febrile illness occurring~     during travel to the tropics.~      The study will yield valuable and prospective data of incidence rate, the clinical and~     etiological spectrum, clinical course and outcome of febrile illness during (and post-)travel~     in a prospective cohorts of travelers. This knowledge may lead to better pre-travel advice.~   "
50943|NCT02900053|"~     Post-Traumatic Stress Disorder (PTSD) is an anxiety disorder that can develop after exposure~     to a terrifying event or ordeal in which there was the potential for or actual occurrence of~     grave physical harm. Traumatic events that may trigger PTSD include violent personal~     assaults, natural or human-caused disasters, accidents, and military combat. People with PTSD~     have persistent frightening thoughts and memories of their ordeal, may experience sleep~     problems, feel detached or numb, or be easily startled. Its lifetime prevalence is quite~     high, with 7-8% in various studies and 4% in french studies.~      The current PTSD treatment usually involves antidepressants as serotonin-specific reuptake~     inhibitors (SSRIs) and Cognitive Behavioral Therapies, such as exposure therapy to~     trauma-linked elements (memories, feelings and thoughts) so the fear associated to the~     traumatic event can decrease. But the therapeutic response stays partial, even combining~     these treatments.~      To improve the PTSD treatment efficiency, innovative approaches are being explored like new~     drugs or cerebral stimulation. This project aims to assess the efficacy of a less known but~     promising therapeutic strategy for PTSD : the use of transcranial Direct-Current Stimulation~     (tDCS) to enhance the trauma-focused therapy results.~   "
50944|NCT02900040|"~     The French DIVAT (standing for Données Informatisées et VAlidées en Transplantation in~     french, and in English Computerized and VAlidated Data in Transplantation ) cohort was~     Kicked off in 1994 by the Transplantation Urology Nephrology Institute of the Nantes~     University Hospital in France. The primary objective of this multicenter computerized~     database was to enable prospective clinical and epidemiological research studies concerning~     kidney transplant recipients, particularly focusing on mid- and long-term clinical outcomes,~     therapeutic strategies and public health issues. The patient-case system of the DIVAT cohort~     allows the monitoring of medical records of all patient-specific and allograft-specific data,~     including bio-banking since 2005. Data are collected from the date of transplantation until~     the graft failure, at each scheduled outpatient visit or hospital admission motivating by a~     new clinical, therapeutical or biological expression. The DIVAT cohort contains information~     on more than 11000 transplant recipients between 1994 and today, issued from 8 French~     university hospitals centers (the DIVAT Network is organized by a consortium agreement). 18%~     of all patients underwent retransplantation and 11% of all kidney transplants originated from~     living donors. The DIVAT network heavily works to ensure a high-quality data collection with~     the aim of exploring adequately the complex post-transplantation process. The Divat network~     encourage collaborations and enables interested researchers to submit a research project by~     completing a request form available on the DIVAT website (http://www.divat.fr/en) describing~     the context, objectives and design of the study~   "
50945|NCT02900027|"~     The purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of~     IONIS APOC-III-LRx given to healthy volunteer subjects.~   "
51073|NCT02898350|"~     Prospective, randomized, split lesion treatment with 4 study Arms to evaluate safety and~     efficacy of combined treatment for minimizing of surgical scars, including post Moh's~     surgery.~   "
50946|NCT02900014|"~     Cell therapy appears to be an alternative to treat bone defects. Scientific advances have~     shown in animal models and in humans that mesenchymal stem cells were good candidates to~     support cellular bone regeneration after transplantation. However, their collection requires~     invasive sampling usually bone marrow. A new candidate stem cells able to stimulate bone~     regeneration has recently been identified in the nasal cavity, these cells are called~     ecto-mesenchymal cells. These stem cells have very similar biological characteristics of~     mesenchymal stem cells of bone marrow. They exhibit a high mitogenic activity and hold great~     potential for differentiation into osteoblast lineage. Given their properties and their ease~     of access within the nasal cavity, ecto-mesenchymal stem cells offer new prospects for cell~     therapy targeting bone involvement. In this context, the ecto-mesenchymal stem cells~     represent a nasal bone reconstruction interesting alternative in particular in indication of~     the cleft. They are directly and easily accessible in these children when conventional~     surgical reconstruction. The investigators propose in this study to validate a production~     method of stem cell called ecto-mesenchymal isolated from a biopsy of the nasal cavity of~     children with cleft lip and palate to be able to soon propose cell therapy innovative in this~     indication.~   "
50947|NCT02900001|"~     This study is to evaluate the efficacy and safety of a routinely deferred invasive strategy~     in comparison with an early invasive strategy in Chinese elderly patients of 75 years or~     older with non-ST elevation myocardial infarction, aiming to test the hypothesis that~     routinely deferred invasive strategy is not inferior to early invasive strategy in such an~     elderly group of patients.~   "
50948|NCT02899988|"~     The main purpose of this study is to evaluate the efficacy of the study drug mirikizumab in~     participants with moderate to severe plaque psoriasis.~   "
50949|NCT02899975|"~     The objective of this study is to validate the prototype of the WeTakeCare- system in the~     real environment (=end users homes) and is embedded in Work-Package 4 (validation and~     evaluation) with the following main tasks:~      T4.1. Definition of methodologies and protocols T4.2. First validation: concept assessment~     T4.3. Second validation: functional assessment T4.4. Third validation: real environment T4.5.~     Final check~      Within the validation phase III of our project the investigators want to validate the~     contents of our fitness and information software WeTakeCare with the target group: elderly~     and their unprofessional caregivers. It runs on the Microsoft Kinect-System, which is~     authorised in Switzerland, and is in accordance with the prescribing information. The~     fitness- and information software contains information about strategies and devices which are~     available in case an older person is not able to perform the everyday movements in a safe and~     easy way.~      Aim of the training and information software is to support elderly to stay independent from~     others help as long as possible. The mentioned software is not a medical or therapeutical~     treatment or a medical or therapeutical product. Performed exercises or presented information~     are highly regarded in the interest of safety and protection of the participants, and serves~     to prevent physical restrictions or damage .~      There is only minimal risk or burden for the participants; the contents of the intervention~     itself (training of basic motor skills, instruction of strategies and the use of assistive~     devices to (partly) compensate restrictions in ADL performance, enablement of caregivers) are~     a standard in rehabilitation of elderly.~      The investigators expect the start of the third validation in October 2015.~   "
50950|NCT02899962|"~     A phase 3 trial comparing the efficacy and safety of LEO 90100 aerosol foam with the aerosol~     foam vehicle used twice weekly as long-term maintenance therapy in subjects with psoriasis~     vulgaris.~      A 12-month, international, multi-centre, randomised, vehicle controlled, double-blind, 2-arm,~     parallel group trial.~   "
50951|NCT02899949|"~     Real-world data can supplement the knowledge gained from traditional randomized controlled~     trials. To date, only a couple of studies (Andrew et al. 2014 and Wilding et al. 2015) have~     been conducted assessing the use of dapagliflozin in the real-world clinical settings in the~     United Kingdom and no research has been done on the use of dapagliflozin in Canadian clinical~     practice settings.~      To the investigators' knowledge, no real-world study exits assessing the impact of using~     dapagliflozin in conjunction with insulin in people with type 2 diabetes mellitus on dosage~     and frequency of insulin, oral antiglycemic agents and hypertension drugs. This study will~     use an electronic medical record-based data that contains demographic, drug coverage, vitals,~     lab results, medical problems and diabetes-related complications, and medication prescription~     information of patients with diabetes received care from all outpatient diabetes clinics in~     London Ontario, Canada to assess the impact of using dapagliflozin in conjunction with~     insulin in patients with type 2 diabetes mellitus on health outcomes, and medications dosing~     and frequency.~   "
50952|NCT02899936|"~     The DOLF Triple Drug Therapy for Lymphatic Filariasis study will determine the frequency,~     type and severity of adverse events following triple-drug therapy (IVM+DEC+ALB, IDA) compared~     to the standard two-drug treatment (DEC+ALB, DA) in infected and uninfected individuals in a~     community in 5 different countries. The objective is to acquire safety, efficacy, and~     acceptability data to assess the safety and acceptability of the IDA drug combination.~   "
50953|NCT02899923|"~     Autoimmune bullous dermatoses are a group of diseases with chronic course. They are provoked~     by the production of autoantibodies against the dermal-epidermal junction or against the~     inter-keratinocyte junctions, resulting in the formation of intra-epidermal or sub-epidermal~     blisters.~      The diagnosis of autoimmune bullous dermatoses is based on clinical and immunopathological~     findings, including skin direct immunofluorescence.~      Systemic corticosteroid therapy is generally considered as the mainstay of treatment for many~     years both for bullous pemphigoid and pemphigus which are the most frequent diseases.~   "
50954|NCT02899910|"~     The purpose of this study is to measure the metabolic and behavioral effects of a 12-week~     yoga program coupled to health education (HED) compared to HED alone.~   "
50963|NCT02899793|"~     Primary Objectives: To assess the antitumor activity (proportion of objective response by~     RECIST 1.1 criteria) of pembrolizumab with objective tumor response in patients with~     persistent, recurrent or metastatic endometrial cancer harboring an ultra-mutated or~     hyper-mutated (MMR gene-defective) phenotype identified by next generation sequencing (NGS)~     and comprehensive genomic profiling (CGP). To determine the nature and degree of toxicity of~     pembrolizumab as assessed by CTCAE in patients with persistent, recurrent or metastatic~     endometrial carcinoma. Secondary Objective(s): To estimate the duration of progression-free~     survival (PFS) and overall survival (OS).~   "
50955|NCT02899897|"~     IV fluid therapy remains an essential haemodynamic objective in the treatment strategy of~     septic shock. Left ventricular systolic dysfunction secondary to sepsis is observed in 40%~     and up to 65% of the population concerned. However, the capacity of the various indices to~     predict the response to IV fluid therapy in septic shock with left ventricular systolic~     dysfunction have not been clearly defined. Measurement of parameters reflecting filling~     pressures during transthoracic echocardiography (TTE) is one of the methods used to evaluate~     cardiac function and estimate the filling reserve, but with no strong evidence. Right heart~     catheterization with determination of cardiac output by pulmonary thermodilution can also be~     used to measure the various parameters commonly used to predict the response to IV fluid~     therapy. Very few data are available with no reliable and clinically relevant data in this~     population with septic shock and left ventricular systolic dysfunction (LVEF ≤ 40%) and the~     response to IV fluid therapy monitored by dynamic indices obtained by transpulmonary~     thermodilution and right heart catheterization. Consequently, the capacity of the various~     indices of preload dependence to predict the response to IV fluid therapy in septic shock~     with left ventricular systolic dysfunction remains difficult to define.~   "
50956|NCT02899884|"~     The purpose of this study is to determine the prevalence of breakthrough cancer pain and~     characterize breakthrough cancer pain in an unselected, representative cohort of cancer~     outpatients with or without pain who attend consultations.~   "
50957|NCT02899871|"~     IBD (inflammatory bowel disease) are associated with various types of joint manifestations,~     especially inflammatory. Patients with IBD treated with anti-TNF commonly report joint~     symptoms, with variable expressions and aetiologies, possibly responsible for impaired~     quality of life, and possibly leading to discontinuation of an effective and validated~     treatment.~   "
50958|NCT02899858|"~     Spinal cord neural circuitry exists in the lumbar enlargement that makes it possible to stand~     and create synergistic, rhythmic stepping activity in the lower limbs. In the past 20 years,~     clinicians have tried to reengage such these circuits for standing and walking in the lower~     spinal cord of paralyzed humans through novel paradigms of physical therapy, pharmacological~     stimulation of the spinal cord, or recently - epidural stimulation of the spinal cord.~     Although standing and stepping with these maneuvers are rudimentary at best, these human~     studies offer promise to restore controlled, lower extremity movement to the spinal cord~     injured (SCI) individual. Evidence from animal data suggests that more focal activation of~     intraspinal circuitry (IntraSpinal Micro-Stimulation - ISMS) would produce more fatigue~     resistant, natural standing and stepping activity in humans. To date, there has been no~     direct confirmation of such circuitry in the spinal cord of bipedal humans who have been~     paralyzed. Furthermore, mapping of such circuitry would provide the basis of a novel~     intraspinal neuroprosthetic that should be able to restore control of standing or walking in~     a manner that is much more physiologically normal and tolerable than by stimulating each~     individual muscle group. Proof of the existence of these spinal circuits in man, and the~     ability to activate and control these circuits by first mapping the spinal cord is the basis~     of this proposal.~   "
50959|NCT02899845|"~     This project aims to study the effect of haptic sensory information delivered at the hand~     using a cane in light touch or light support condition on postural stability and spatial~     and temporal gait parameters of elderly subjects with and without walking difficulties~   "
50960|NCT02899832|"~     This study will included 20 children presenting with epilepsy with spasms. It aims to offer~     these children, non invasively and without supplementary examinations, a recording of local~     and cerebral hemodynamic changes concomitant with an electroencephalographic recording during~     epileptic episodes. This will be carried out by combining optical imaging using near~     infra-red spectroscopy (NIRS) with electroencephalography (EEG), in a simultaneous~     high-resolution (HR) recording.~      This study is among those based on multimodal analyses of epilepsy, combining methods of~     analysis of electrical activity (electrical imaging) and hemodynamics (optical imaging).~      Surface electroencephalography (EEG) is a precious tool enabling the study of neuronal~     dysfunction from a functional point view. It is used in the routine follow-up of children~     with epilepsy. Optical imaging is a promising medical imaging technique. It uses light in the~     spectral regions of near infra-red as a source of radiation. It is quantitative, rapid, non~     invasive, and inoffensive which could easily be used at the child's bedside or in a clinical~     setting and can provide metabolic information about cerebral function.~      This study is multidisciplinary, which calls upon the skills of neurophysiologists,~     biophysicists, and clinicians~   "
50961|NCT02899819|"~     The MecoExpo project seeks to evaluate the in utero exposure of newborns in the Picardie~     region to commonly used pesticides. These pesticides were selected in a pilot study (the~     Mecopic study) on the basis of their toxicity (effects on foetal development, endocrine~     perturbation, neurological toxicity and carcinogenicity) and a certain number of indicators~     of pesticide use and the presence of pesticide in the environment in Picardie.~      These substances (or their metabolites) will be measured in the each newborn's meconium (the~     first faeces after birth) and each newborn's mother's hair in the Picardie region during the~     study period. The mother's exposure will also be assessed using a retrospective questionnaire~     (filled out within a few days of the delivery).~      Thus, the MecoExpo project will enable the investigators to:~        1. evaluate the relationships between foetal exposure (via the meconium), maternal exposure~          (via the hair and the questionnaire) and clinical parameters measured at birth (term,~          length, weight, etc.).~        2. map pesticide exposure across the Picardie region.~        3. create a meconium bank in Picardie (the first ever meconium bank in France).~   "
50962|NCT02899806|"~     The aim of this study was to investigate the impact of multimedia information on epidural~     anesthesia. Pregnant women were randomly assessed to get a video information in addition to~     an oral and written information on epidural anesthesia. Maternal satisfaction concerning the~     quality of the information as well their anxiety and understanding of the procedure were~     assessed and compared in both groups.~   "
50964|NCT02899780|"~     This study is a first-in-man clinical trial using fiber optically delivered ultraviolet light~     for reducing viable bacteria within indwelling tunneled dialysis catheters.~   "
51074|NCT02898337|"~     Torsades de pointes (TdP) is a polymorphic ventricular tachycardia associated with~     prolongation of the heart rate-corrected QT (QTc) interval on the electrocardiogram (ECG).~     TdP can result in catastrophic outcomes, including sudden cardiac death. QTc interval~     prolongation is a well-known adverse event associated with methadone use. While some risk~     factors for methadone-associated QTc interval prolongation and TdP have been identified, the~     contribution of interacting drugs and concomitant administration of other QTc~     interval-prolonging agents to overall risk has not been determined. The effect of ECG~     screening and monitoring on clinical outcomes in patients taking methadone has not been~     evaluated, and clinical opinion regarding routine ECG and risk factor monitoring varies.~     Twelve lead ECGs are costly and time-intensive for clinic staff. ECG screening in selected~     patients based on presence of QTc interval risk factors, rather than broadly in all patients~     taking methadone, would facilitate more targeted, strategic QTc interval monitoring. The~     FDA-approved AliveCor® handheld smart phone/tablet device records a single lead ECG (iECG)~     within 30 seconds. Use of this device may facilitate simpler, more rapid and less costly ECG~     monitoring in patients receiving care in narcotic treatment centers.~      Our long-term goals are to determine mechanisms by which drugs cause arrhythmias, to identify~     patients at greatest risk of drug-induced arrhythmias, and to determine safe and effective~     methods for prevention and management of drug-induced arrhythmias.~      Specific Aim 1: Identify independent risk factors for methadone-induced QTc interval~     prolongation in patients undergoing care in a narcotic treatment center.~      Research Design: This will be a retrospective/prospective analysis of ECGs and health~     information from patients receiving methadone therapy in the Eskenazi Health Midtown Narcotic~     Treatment Center in Indianapolis, IN. Currently, at the Midtown Narcotic Treatment Center,~     baseline 12-lead ECGs are recorded for all patients prior to initiation of methadone therapy;~     follow-up ECGs are obtained approximately 2 weeks after methadone initiation only in patients~     with a baseline prolonged QTc interval. At the start of the study, methadone-treated patients~     who have not had follow-up ECGs on methadone therapy will be identified and contacted~     prospectively. Those consenting to participation will undergo a follow-up 12-lead ECG to~     determine QTc interval during methadone maintenance therapy. For all patients, retrospective~     analysis of the electronic medical record will be performed to document sex, pregnancy~     status, age, family history, current and past medical history, and concomitant use of~     prescribed, over the counter, and illicit drug use with the aim to identify all potential~     risks. QTc interval prolongation will be defined as QTc interval ≥ 500 ms or an increase in~     QTc interval of ≥ 60 ms compared with the baseline QTc interval. Electronic health~     information variables will be compared in patients who develop methadone-associated QTc~     interval prolongation versus those who do not using univariate analysis. Patients with~     prolonged QTc interval at baseline will be excluded from the study.~      Specific Aim 2: Validate the handheld AliveCor® smart phone/tablet iECG device as a simple,~     rapid method of monitoring QTc intervals in methadone-treated patients in a narcotic~     treatment center.~      Research Design: A separate cohort of patients will be utilized to validate the AliveCor®~     device for use in measuring QTc intervals in patients initiated and maintained on methadone~     in a narcotic treatment center. Twelve lead ECGs and simultaneous single lead ECGs using the~     AliveCor® device will be recorded for all newly enrolled patients at baseline and again after~     six weeks of methadone therapy. The QTc identified by the 12-lead ECG will be compared to the~     single lead ECG for all baseline and follow-up recordings to validate the use of the~     AliveCor® device for potential use in narcotic treatment centers to reduce cost and save~     time. Comparison of QTc intervals between the 12-lead and single lead measurements will be~     performed using the Bland-Altman method for analysis of measurement agreement. The mean and~     95% confidence interval of the difference in QTc interval between the two methods will be~     calculated.~      This will be a pilot study to justify a larger extramural study to develop and validate a~     risk score for methadone-induced QTc interval prolongation and to use the handheld ECG device~     for QTc interval monitoring in patients identified as high-risk using this risk score. Our~     rationale is that identification of risk factors for methadone-induced QTc interval~     prolongation and quantification of degree of risk conferred by each risk factor will~     ultimately reduce the incidence and risk of QTc interval prolongation through targeted ECG~     monitoring of patients at highest risk and modulation of modifiable risk factors.~   "
51454|NCT02893397|"~     The goal of this clinical research study is to learn if regular exercise is possible for~     children and young adults with bone cancer who are having chemotherapy.~   "
50965|NCT02899767|"~     Acute myeloid leukaemia (AML) is a haematological malignant disease characterized by an~     uncontrolled proliferation of immature hematopoietic cells. Over the last two decades,~     clinical trials have demonstrated an improved response rate in younger adult AML. Aggressive~     induction plus more potent intensification programs with chemotherapy alone or chemotherapy~     plus stem cell transplantation (SCT) has improved treatment results. Advances in~     understanding disease biology, improvements in induction and consolidation program, and~     better supportive care have also all contributed. A number of clinical and laboratory~     characteristics influence the response to treatment and, thus, the survival of patients with~     AML. Among them, cytogenetic at diagnosis represents the most important prognostic variable.~     However, other factors may have a prognostic value and may influence patient's outcome.~      Anaemia and thrombocytopenia are cardinal manifestations of AML. Over the last decades, it~     has become apparent that the frequency of allogeneic blood transfusions can modify host~     immunity and clinical outcomes. Anaemia has long been recognized as an adverse prognostic~     factor in myelodysplastic syndrome (MDS), which represents a pre-leukemic disease. Red blood~     cell (RBC) transfusion need was identified as a strong and independent risk factor for~     survival in MDS, for which the presence and severity of anaemia were attributed to a clonally~     advanced and biologically more aggressive disease.~      Based on these data, we retrospectively assessed the prognostic value of RBC and platelet~     transfusions at the time of diagnosis and the frequency of transfusions during the first~     induction course of chemotherapy in a large unselected group of patients with previously~     untreated AML.~   "
50966|NCT02899754|"~     Veterans have a high risk of developing lung in comparison to general populations due to~     their older age and smoking history. Recent evidence indicates that lung cancer screening~     with low dose CT scan reduces lung cancer mortality among older heavy smokers. However, the~     rates of false positive findings are high, requiring further testing and evaluation.~     Preliminary studies report that while some Veterans are enthusiastic about screening, others~     are highly reluctant. Patient preferences should be considered as part of an informed~     decision making process for this emerging paradigm of lung cancer control. Effective methods~     for preference assessment among Veterans have not yet been developed, evaluated, and~     integrated into clinical practice. The specific aims of this study are to 1) elicit patient~     and provider stakeholder input to inform the development of a lung cancer screening decision~     tool, 2) develop a web based Lung Cancer Screening Decision Tool (LCSDecTool) that~     incorporates patient and provider input, and 3) evaluate the impact of the LCSDecTool~     compared to usual care on the decision process, clinical outcomes, and quality of life.~      To Date (5/8/18)-This project involves the recruitment of both Veterans as well as health~     care providers/leaders. Patient recruitment efforts at both sites will target male and female~     patients enrolled in a Patient Aligned Care Teams (PACT) who are eligible for lung cancer~     screening. Our recruitment goals for patients are 40% African American, 5% Hispanic patients,~     and 10% women. To Date, 32 Veterans have signed the consent for and completed their portion~     of the trial (16 at CMCVAMC and 16 at West Haven, CT). To Date, 61 Providers have completed~     their portion of the trial (18 at CMCVAMC and 43 at West Haven, CT). Enrollment for Phase 1~     is complete. Enrollment for Phase 2 will begin in June, 2018.~   "
50967|NCT02899741|"~     The purpose of this study is to determine whether omega-3 is effective in the treatment of~     medically intractable epilepsy as adjunctive therapy.~   "
50968|NCT02899728|"~     This randomized phase II trial studies how well olaparib, cediranib maleate, and standard~     chemotherapy work in treating patients with small cell lung cancer. Drugs used in~     chemotherapy, such as carboplatin, cisplatin, and etoposide, work in different ways to stop~     the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Olaparib and cediranib maleate may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. Olaparib, cediranib maleate,~     and standard chemotherapy may work better in treating patients with small cell lung cancer.~   "
50969|NCT02899702|"~     IGHN2 is an international, multicenter, double blind, randomized controlled trial aimed at~     assessing the efficacy on organ dysfunctions of Intravenous Immunoglobulins (IVIG) treatment~     in the acute phase of streptococcal or staphylococcal toxic shock syndrome in children.~   "
50970|NCT02899689|"~     Women undergoing mechanical cervical ripening for labor induction will be randomized to~     Dilapan-S® versus Foley bulb. The investigators hypothesized that osmotic cervical dilators~     (Dilapan-S®) are as effective as Foley bulb catheter in rates of vaginal delivery.~   "
50971|NCT02899676|"~     The aim of this study was to identify neural correlates involved in arthmetics processing in~     adults and children aged 8 to 14 with normal cognitive function. Brain area will be~     identified by functional magnetic resonance imaging (IRMf).~   "
50972|NCT02899663|"~     Systematic retrospective medical chart and medical imaging file review of all patients~     receiving brain MRI for the follow-up of glioblastoma.~   "
50973|NCT02899650|"~     The purpose of this study to determine if older adults who are healthy and physically active~     (i.e., Masters athletes) demonstrate slower rates of recovery from unaccustomed strenuous~     exercise of downhill running than younger peers.~   "
50974|NCT02899637|"~     The main objective is to conduct a study protocol to investigate the effects of repetitive~     Transcranial Magnetic Stimulation (rTMS) on sensory and motor performance of individuals with~     incomplete spinal cord injury (iSCI) . A double-blind randomized sham-controlled trial of~     patients with iSCI will be conducted.~   "
50975|NCT02899624|"~     Bicuspid aortic valve (BAV), congenital anomaly present in 2% of the population, is defined~     by the presence of two sigmoid valves instead of three. It is conventionally associated with~     histological abnormalities of the wall of the ascending aorta, risk factors of aortic~     dystrophy observed in 50% of cases, and dissection. Long considered an accident of~     development, the discovery of mutations in the NOTCH1 gene in 2 families alternating BAV and~     aortic dystrophy suggests the existence of a genetic predisposition and a common genetic~     origin for these two pathologies.~      Data on the genetic basis of the BAV are still limited, but the existence of a large~     phenotypic diversity suggests the involvement of other genes. The establishment of large~     collections of DNA will allow great advances in this field.~      The purpose of this project is to confirm the existence of a genetic determinism at the~     origin of the BAV with or without dystrophy of non syndromic ascending aorta, identifying~     genetic defects associated with the presence of a BAV in a series of candidate genes.~   "
50976|NCT02899611|"~     Patients with medically refractory epilepsy will be treated by intracerebroventricular (ICV)~     delivery of valproate using an implantable drug pump system. The dose of valproate will be~     escalated weekly during a blinded-evaluation period through Day 64 to determine the maximum~     tolerated dose (MTD). After Day 64, patients can continue for 52 weeks in the open-label~     evaluation period (non-blinded).~   "
51490|NCT02892929|"~     This randomized clinical trial was designed to test the effectiveness of Motivational~     Interviewing in lowering blood pressure during six months follow-up.~   "
50977|NCT02899598|"~     Neonatal thrombocytopenia isoimmunization maternal-fetal is related to maternal immunization~     against fetal platelet antigens with paternal origin not present in the mother. It is~     considered the equivalent of hemolytic disease of the newborn. The incidence of this disease~     is about 1 in 800-1000 births. The most severe forms associated petechiae, purpura or~     cephalhematoma at birth with a major risk of cerebral hemorrhages (20% to 25% of cases) can~     cause the death of the child (15%) or severe neurological troubles (15-30%) Biologic~     diagnosis requires the detection of anti-platelet antibodies with maternal determination of~     platelet phenotypes and genotypes of the two parents.~      The objective of this work is to develop specific molecular tools to fetal platelet~     genotyping from maternal blood. We are particularly interested to antigens HPA-1, HPA-5 ,~     HPA-3 and HPA-4. We evaluate the sensitivity and specificity of this test by comparing these~     results with those obtained from an invasive sampling of amniotic fluid.~      This is a prospective study to assess the technical and diagnostic performance of a new~     molecular method noninvasive prenatal diagnosis of platelet genotyping.~   "
50978|NCT02899585|"~     The aim of the research is to detect prematurely vulnerable patients needing a global~     coverage in integrated care with a created and metrological validated score.~   "
50979|NCT02899572|"~     Erection disorders constitute the first sign of vascular injury in type 2 diabetes patients.~     The important frequency of these disorders and their consequences in term of quality of life~     have a strong contrast with the actual interest showed for them by the medical community.~      Natural evolution of the disease and its management make that these disorders often occur~     little time after a therapeutic change. As a consequence, patients often accuse their~     medication to be responsible for the appearance of these disorders. This confusion,~     associated to false believes that may have the patients on their disease or their treatment,~     often leads to treatment discontinuation which has a deleterious effect on the disease~     evolution.~      Educational therapy programs showed a positive impact on therapeutic adherence. Increasing~     patients' knowledge on their disease and treatments increases their therapeutic adherence and~     makes it easier to balance diabetes and therefore limits complications appearance.~      Educational therapy programs concern today the disease, its process, its evolution, its~     treatments, their efficacy, their adverse effects but erection disorders are not specifically~     addressed.~      This study aims to evaluate the impact of a sexology consultation on diabetes balance~     measured via HbA1c rate. This consultation aims at precising this particular symptom of~     erection disorders, without any medicine prescription. The aim is to explain to patients the~     different links between their symptoms, diabetes, medicines and themselves.~   "
50980|NCT02899559|"~     This primary object of this study is to test to the hypothesis that the both the nudge and~     boost messages will increase short term gym utilization relative to the control condition but~     that only the boost message will increase long-term gym utilization.~      Non-technical summary: College students will receive one of three messages about exercise.~     Their card swipe data as a measure of gym utilization will be tracked as an assessment of the~     effect of those messages.~   "
50981|NCT02899546|"~     Septi-PICC study aims at assessing incidence of Peripherally Inserted Central Catheter~     (PICC)-related infections among patients managed in the University Hospital of La Reunion for~     PICC setting.~   "
50982|NCT02899533|"~     In this study positron emission tomography (PET/CT) imaging will be used to evaluate~     evaluation of estrogen receptor heterogeneity and functionality in Pulmonary Arterial~     Hypertension (PAH) using the investigational radiotracer [18F]fluoroestradiol (FES).~   "
50983|NCT02899520|"~     The objective of this study is to compare two methods of pelvic floor muscle training:~     reference method versus CMP ® method ( (Connaissance et Maîtrise de Périnée : Knowledge and~     Control of Perineum)~   "
50984|NCT02899507|"~     The purpose of this study is to determine whether there is potential benefits of prophylactic~     antibiotic treatment in comatose survivors of out-of-hospital cardiac arrest (OHCA) treated~     in intensive care unit with therapeutic hypothermia.~   "
50985|NCT02899494|"~     To emit voluntarily sounds mastered during the childbirth is a practice found in certain~     cultures of country of Africa or Muslim or gypsy traditions. Today, because of the medical~     coverage and because of the childbirth in a hospital environment, this tradition is not~     anymore transmitted.~      The emission of a sound vibration conjugated to a positive intention managed during the~     childbirth was experimented with around thirty mothers. In the term of this pilot study, most~     of the women expressed one felt very positive towards the new method, in particular when they~     compared it with a previous childbirth where this method was not used.~      During these childbirths, the midwives also indicated a shortening of the working time.~      The present study aim essentially is to confirm the positive effect of the method on the felt~     of the childbirth.~   "
50986|NCT02899481|"~     Investigators will perform a multicentric randomized controlled trial comparing the effect of~     transabdominal and transperineal ultrasound in pregnant women in the second stage of labor,~     in whom it was decided an operative delivery. Our objective is to evaluate the impact of~     intrapartal ultrasound measurements, as an auxiliary to clinical evaluation, in the efficacy~     of an instrumental delivery.~   "
50987|NCT02899468|"~     The purpose of the study is to evaluate the feasibility and effectiveness of a novel virtual~     reality (VR) therapeutic rehabilitative device (BrightBrainerTM) to treat patients with~     traumatic brain injury (TBI). These patients, service members with TBI, can be both with and~     without upper limb dysfunction and use uni- and bimanual virtual reality (VR) exercises to~     improve cognitive and motor function, as well as mood.~   "
50988|NCT02899455|"~     A phase 3 study to evaluate efficacy and safety of Co-administered HGP0904, HGP0608 and~     HGP0816 in Patients with Hypertension and Dyslipidemia~   "
51006|NCT02899221|"~     This phase I trial studies the side effects and best way to give hyperthermia and high dose~     rate radiation therapy in treating patients with prostate cancer that has come back after~     prior radiation treatment. Radiation therapy, such as high dose rate brachytherapy, uses~     radioactive material placed directly into or near a tumor to kill tumor cells. Hyperthermia~     therapy may make tumor cells more sensitive to the effects of radiation therapy by heating~     them to several degrees above normal body temperature. Giving hyperthermia and high dose rate~     radiation therapy may work better in treating patients with recurrent prostate cancer after~     radiation.~   "
54422|NCT02854605|"~     The primary objective of this study is to evaluate the safety and tolerability of GS-9674 in~     participants with nonalcoholic steatohepatitis (NASH).~   "
50989|NCT02899442|"~     With around 15 to 20% of workforce engaging in nightshift work in modern society for obvious~     economic and social reasons, the consequences of night work on cardiovascular risks are~     substantial. Compared to day workers, it was reported higher risks of cardiovascular diseases~     (estimated at 40%) and of metabolic syndrome (1.5 times) in shift workers. The occurrence of~     metabolic syndrome increases the risk to develop high blood pressure, diabetes and~     cardiovascular events. Because some characteristics of night work are potentially modifiable,~     some preventive strategies could be applied to reduce its adverse effects. For shift workers,~     some recent guidelines (High Health Authority, 2012 & 2016) and fruitful literature propose~     to develop regular assessments of cardiovascular risk factors and occupational activities,~     and stress the need to expand preventive strategies. Moreover, some recent French laws~     provide an opportunity to implement preventive interventions and specific monitoring through~     the occupational physicians network. However, whether the concept is defined, the exact~     content, method and the potential benefits are unknown. The investigator assume that~     individual advice related to collective countermeasures referenced on guidelines (applied on~     worksite within plant) could lead a better improvement on incidence of metabolic syndrome~     compared to those that benefit only individual advice.~      Main objective:~      To measure the benefit from implementation of individual and collective prevention (dispensed~     in worksites within plants) on metabolic syndrome compared to strategy relying only on~     individual prevention among night workers, over 2 years' follow-up. The secondary objectives~     of the study are to evaluate in both groups:~        1. Observance of different types of preventive strategies~        2. Impact of observance of preventive advice on metabolic syndrome in shift workers and on~          each component of metabolic syndrome~        3. Determinants which promote the up-take of preventive strategies among night workers~        4. The countermeasures which could be applied and effective within company 5)~          Medico-economic assessment is planned from an ancillary study.~   "
50990|NCT02899429|"~     Systematic study of the ultrasound infringements of tendons chest expanders of entheses the~     most involved in spondylarthropathies and small joints of hands and feet in expanding~     patients of psoriasis to estimate if there is an infra-clinical infringement of the psoriasic~     rheumatism .~   "
50991|NCT02899416|"~     BELINDA is a follow'up of subjects included 10 years ago in HELENA study which was a~     cross-sectional study carried out from 2006 to 2007 in more than 3500 adolescents aged from~     12.5 to 17.5 years old through 10 Europeans towns from 9 countries.~      BELINDA main objective is to assess CV risk using PDAY score (Pathobiological Determinants of~     Atherosclerosis in Youth) during young adulthood (20 to 31 years) and analyze lifestyle risk~     factors from adolescence (12 to 18 years). This analyze may define new CV risk factors and~     risk population cluster.~   "
50992|NCT02899403|"~     In the perspective to better evaluate the efficacy of new treatment strategies for Alzheimer~     disease (AD), it appears important to develop experimental paradigms to precisely measure~     cognitive endpoints/biomarkers that may be used in healthy volunteers as tools to validate~     drug efficacy profile.~      The use of Electroencephalography (EEG) may be, therefore, a good candidate. The purpose of~     the present study is to use EEG to more precisely explore cognitive processes in healthy~     subjects, with a particular interest in episodic and working memory functions that are~     usually altered in both AD and Mild Cognitive Impairment (MCI) as well as to better~     understand underlying neural mechanisms involved in these processes.~   "
50993|NCT02899390|"~     Diabetes is a major non communicable chronic diseases in the world. It occupies the fourth or~     fifth leading cause of death in most high-income countries and there is strong evidence that~     has epidemic proportions in many developing countries, including Mexico. Like diabetes,~     prediabetes is associated with obesity and insulin resistance, thus promoting a lifestyle~     with healthy eating and physical activity can reduce weight and in turn the risk of diabetes.~      Several studies have shown that it is possible to prevent or delay the development of type 2~     diabetes through a lifestyle intervention based on diet and physical activity. The National~     Diabetes Prevention Program is a study based on the Diabetes Prevention Program conducted in~     real-world conditions.~      It is known that the acculturation of some ethnic groups has led to the increase in certain~     chronic degenerative diseases due to increased associated risk factors. The rural Yaqui tribe~     has a high prevalence of overweight, obesity, high triglycerides and type 2 diabetes. In~     addition to the rural Yaqui tribe there is another settlement of this tribe in the city of~     Hermosillo Sonora. Information on the health of this ethnic group is limited, however, it is~     known that being seated in an urban setting with an obesogenic lifestyle, which has been~     shown to have serious health effects in other populations, suggesting a high prevalence~     chronic non-communicable diseases such as obesity, type 2 diabetes and hypertension at this~     ethnic group.~      The present study is a translational research clinical trial to evaluate the effectiveness of~     the National Diabetes Prevention Program to improve obesity parameters (weight, BMI, waist~     circumference) and increase physical activity in adults who are at risk of diabetes in the~     Yaqui tribe established in Hermosillo, Sonora.~   "
50994|NCT02899377|"~     This is a pilot imaging study to determine whether molecular imaging with 18^F~     fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT),~     11^C-Methionine (MET) PET/CT, and salivary gland magnetic resonance imaging (MRI) with~     Dotarem (gadoterate meglumine) have the potential to characterize and quantify disease~     manifestations in primary Sjögren's syndrome (pSS) subjects. This will be achieved by~     assessing the associations and consistency between the imaging techniques studied, clinical~     assessments (salivary and tear flow and clinical scores), laboratory biomarkers, and~     histological findings on minor salivary gland biopsy.~      In this study, healthy volunteers will be enrolled in Group A and pSS subjects in Group B.~     The subjects will be required to undergo screening and baseline assessments including~     unstimulated and stimulated salivary flow and Schirmer's test; an imaging visit (Visit 1); a~     sample collection visit (Visit 2) for repeat of selected baseline assessments and a minor~     salivary gland biopsy for pSS subjects only; and a follow-up visit. The total duration of~     participation in the study will be up to 11 weeks.~   "
51007|NCT02899208|"~     This study aims to investigate whether an actigraph, measuring in-hospital activity, used for~     a week after discharge from the ICU at Zealand University Hospital Køge, can predict physical~     function at three-month follow up.~      The hospital activity will be measured with actigraphy, a measurement tool that quantifies~     activity level. The activity will be measured for 7 days after ICU discharge. The actigraph~     is to be worn as a bracelet.~      The physical function will be measured with Chelsea Critical Care Physical Assessment Tool~     (CPAx). CPAx is assessed at ICU discharge and after three months.~   "
51008|NCT02899195|"~     Patients with pleural mesothelioma that can not be surgically removed will receive~     durvalumab, in combination with standard chemotherapy of pemetrexed and cisplatin as~     first-line treatment.~      Durvalumab is a type of drug called a monoclonal antibody (a type of protein). Laboratory~     tests show that it works by allowing the immune system to detect your cancer and reactivates~     the immune response. This may help to slow down the growth of cancer or may cause cancer~     cells to die.~      The purpose of this study is to see whether adding durvalumab to standard chemotherapy will~     improve overall survival (OS).~   "
50995|NCT02899364|"~     Rationale: the cornerstone treatment of a heart attack is a procedure called primary~     percutaneous coronary intervention (PPCI): the cardiologist uses a catheter and guides it~     through an artery, mostly the wrist artery, to the site of the narrowing in the coronary~     artery in the heart and opens it with a balloon. Thereafter a small metal tube is placed at~     the site of the narrowing to keep the artery open). However, a heart attack still leads to~     irreversible injury to the heart with a risk of heart failure. The investigators have~     evidence from (cell/animal) that administration of hydrogen sulfide (H2S), which is also made~     in the human body, has been shown to protect the heart muscle and organs from damage caused~     by the lack of oxygen resulting from a heart attack. Data in humans suggests that sodium~     thiosulfate (STS) (a medicine that releases H2S in the body, and is already used to treat~     other diseases, i.e. cyanide poisoning and renal failure associated diseases) can be~     administered safely.~      Objective: to evaluate if sodium thiosulfate protects the heart from damage caused by a heart~     attack.~      Study design: a single centre, double blind (both doctor and patient do not know which~     treatment patient gets), randomized controlled clinical trial.~      A total of 380 patients, aged 18 years and above, undergoing treatment for a first heart~     attack are divided in two groups (decided by chance): 1 group receives sodium thiosulfate,~     the other receives a fake medicine (salt water that looks exactly like sodium thiosulfate).~      After 4 months patients receive a magnetic scan of the heart to evaluate the permanent damage~     of the heart muscle. When comparing the patients from both groups to each other the~     investigators can say something about the effectivity sodium thiosulfate.~   "
50996|NCT02899351|"~     In this research study, the investigators want to learn more about whether the Respiratory~     Volume Monitor (ExSpiron) can accurately measure breathing in infants less than 12 months of~     age. The Respiratory Volume Monitor uses up to 5 stickers that are placed on the chest to~     measure the amount of air going in and out of the lungs with each breath (Tidal Volume), the~     number of times per minute a breath is taken (Respiratory Rate), and the amount of air going~     in and out of the lungs per minute (Minute Ventilation).~      It is important for medical staff to be able to collect information about breathing~     non-invasively because it may help determine if certain children are experiencing breathing~     problems sooner than the way it is currently detected.~      The goal of this study is to determine if the Respiratory Volume Monitor works accurately in~     infants less than 12 months of age.~   "
50997|NCT02899338|"~     To characterize and compare the pharmacokinetics and to assess the safety of BI 695501 after~     single injection using either auto injector or prefilled syringe.~   "
50998|NCT02899325|"~     Liver cancer is one of the leading causes of cancer death among Asian men. If diagnosed early~     the disease is treatable with surgery. Current conventional imaging modalities have~     limitations to early detection. This study proposes to use 18F-FGal and 18F-FDG PET/CT scans~     to compare the clinical efficacy of diagnosing hepatocellular carcinoma (a type of liver~     cancer) using these PET/CT scans.~   "
50999|NCT02899312|"~     Prostate cancer (PC) is the third most common cause of cancer death in men. Most patients~     with localized PC will be cured with surgery or radiation therapy, but up to 35% of patients~     will have their PC return. Whether it has returned locally or distantly determines which type~     of treatment they will receive. Current conventional imaging modalities have limitations~     particularly at low prostate-specific antigen (PSA) levels. This study proposes to use~     Fluorine-18-2-(3-(1-carboxy-5-[(6-[18F]fluoro-pyridine-3-carbonyl)-amino]-pentyl)-ureido)-pen~     tanedioic acid (18F-DCFPyL) Positron Emission Tomography / Computer Tomography (PET/CT) scans~     which targets prostate-specific membrane antigens (PSMA) to detect where in the body the PC~     has recurred.~   "
51000|NCT02899299|"~     The purpose of this study is to test the effectiveness and tolerability of the combination of~     Nivolumab and Ipilimumab compared to Pemetrexed and Cisplatin or Carboplatin in patients with~     unresectable pleural mesothelioma.~   "
51001|NCT02899286|"~     To evaluate the efficacy of PEG-BCT-100 in patients with relapsed or refractory acute myeloid~     leukemia (AML) in terms of remission rate.~   "
51002|NCT02899273|"~     In Germany about 5 to 20% of children suffer from early childhood caries (ECC). Preceding~     results of eye-tracking-studies on the perception of patients with unilateral cleft and~     patients with severe orthognathic malocclusion let us assume that caries and missing teeth~     might influence the observer's focus. The aim of this study is to test the hypothesis that~     the faces of patients with ECC and patients with signs of dental treatment (crown, gap etc.)~     are contemplated differently from and assessed more negatively than healthy patients.~     Particular attention should be paid to potential differences between the findings of the two~     observer-groups (medical laypersons/ dental students).~   "
51003|NCT02899260|"~     This study is designed as a prospective, randomized controlled trial that will compare the~     use of the peanut exercise ball in laboring patients compared with no use of the exercise~     ball. We hypothesize that use of the peanut ball decreases the incidence of cesarean section.~   "
51004|NCT02899247|"~     This trial, based on a split mouth and double-blind design, will evaluate the effects of a~     surface sealant on the clinical performance of composite resin class I restorations.~     According to eligibility criteria, 10 pairs of upper and lower molars or premolars will be~     restored with Esthet X composite resin. For each pair, one surface will be sealed with~     Lasting Touch surface sealant. A clinical evaluation will be performed by two experienced~     operators using modified USPHS (United States Public Health service) after 5 years after~     treatment. Data will be analyzed using the McNemar test (p < 0.05).~   "
51005|NCT02899234|"~     According to the World Health Organization cigarette smoking is today one of the leading~     single causes of preventable death and morbidity. The electronic cigarette (e-cigarette) has~     been marketed as a safer alternative to conventional cigarettes, and its global sales~     continue to grow exponentially each year. Despite growing e-cigarette use, scientific data on~     health effects are insufficient in some respects and completely lacking in others. Therefore~     the current study is designed to investigate the effects of active e-cigarette inhalation on~     the cardiovascular and respiratory systems.~   "
51044|NCT02898727|"~     This study aims to show that brain metastases from Human Epidermal Growth Factor Receptor~     Type 2 (HER2) positive breast cancers are able to be controlled by local therapies,~     Stereotactic Radiosurgery (SRS) and/or Neurosurgery (NS), without the need for Whole Brain~     Radiotherapy (WBRT).~   "
60033|NCT02781051|"~     Pilot study to assess a multi-component intervention to increase physical activity among~     breast cancer survivors with depression.~   "
51009|NCT02899182|"~     Introduction: Transrectal ultrasound-guided prostate biopsy (TUPB) is the gold standard~     diagnostic tool for prostate cancer and, though may be well tolerated for some patients,~     about 65 to 90% of then still complain of discomfort, weather associated or not to pain.~     Therefore, as a manner of improvement in visual analogic pain score (VAS) and satisfaction~     between those patients, the aim of this study is to propose the gas mixture N2O-O2 50-50%, as~     a non-invasive, safe and cost-effective method to deliver analgesia and/or sedation, without~     the need for an anesthesiologist.~      Materials and methods: A randomized clinical trial, simple blind, which took place in~     Hospital Universitário Antônio Pedro, Niteroi, RJ, within two groups containing 42 patients~     each, divided in conventional (C), which received 100% oxygen and nitrous oxide (NO), which~     received inhalation of the mixture N2O-O2 50-50% from a self-demand valve during exam. They~     were accessed for pain with VAS, answered a satisfaction task and were recorded about~     collateral side effects.~   "
51010|NCT02899169|"~     The investigators design a multicenter randomized controlled trial to prove that RIF plus~     ATRA is possibly superior to ATO plus ATRA as consolidation and maintenance treatment for the~     patients with non-high-risk APL.~   "
51011|NCT02899156|"~     Delirium within the intensive care unit (ICU) is associated with poor outcomes such as~     increased mortality, ICU and hospital length of stay (LOS), and time on mechanical~     ventilation. Benzodiazepine (BZD) exposure is an independent risk factor for development of~     delirium. Reversal of hypoactive delirium represents a potential opportunity for reducing~     duration of delirium and subsequent complications.~      This is a single-center randomized, double-blind, placebo-controlled study of critically ill~     adult patients with benzodiazepine-associated hypoactive delirium. The hypothesis is that~     flumazenil continuous infusion reverses hypoactive delirium associated with BZD toxicity and~     thereby reduces duration of delirium and ICU LOS.~   "
51012|NCT02899143|"~     The purpose of this study is to compare the effect of a short course antimicrobial therapy~     (5-days) versus a 10-days therapy on sepsis-related organ dysfunction.~   "
51013|NCT02899130|"~     This trial will study the effect of a polyherbal capsule in lowering the viral load of~     patients with chronic Hepatitis B infection and record the incidence of from Hepatitis B~     surface antigen elimination in 12 months~   "
51014|NCT02899117|"~     The proposed project will examine feasibility and preliminary efficacy of a yoga intervention~     in the pediatric oncology unit at Connecticut Children's Medical Center (CCMC) and includes~     two parts: (1) a survey of children and parents regarding preferences (e.g., convenient~     days/times), experiences and expectations regarding yoga (including barriers and positive~     expectancies) and (2) an eight week clinical trial of a yoga intervention in 10 pairs of~     children and parents.~   "
51015|NCT02899104|"~     Categorize the clinical parameters and patient determinants that drive physician decision~     making for treatment selection including Radium-223 for patients with mCRPC.~   "
51016|NCT02899091|"~     The objective of the study is to evaluate the safety and the potential therapeutic effects of~     CB-AC-02 Intravenous Transplantation in patients with Alzheimer' disease comprised of 2~     treatment cohorts:~   "
51017|NCT02899078|"~     This phase Ib/II trial studies how well ibrutinib and nivolumab work in treating patients~     with previously-treated kidney cancer that has spread to other parts of the body. Ibrutinib~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~     Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to~     grow and spread. Giving Ibrutinib and nivolumab may work better in treating patients with~     metastatic kidney cancer.~   "
51018|NCT02899065|"~     This will be a prospective, patient-oriented, pilot randomized clinical trial to evaluate (in~     aggregate) both the use of the Roche Cobas Liat Flu/RSV Assay and the use of pharmacist-led~     education for providers in the interpretation of these test results.~   "
51019|NCT02899052|"~     A Phase 2, open-label, dose escalation study to evaluate the safety and efficacy of~     venetoclax in combination with carfilzomib-dexamethasone (Kd) in participants with relapsed~     or refractory MM and have received 1 to 3 prior lines of therapy.~   "
51020|NCT02899039|"~     IgG4-related disease is a rare and very recently identified pathology, whose frequency is~     certainly underestimated.~      The clinical presentation varies among affected organs, and most often, patients have at~     least three organ damage.~      These organs exhibit tissue infiltration mononuclear polymorphic cells with often severe~     fibrosis progression resulting in a loss of function.~      The biomarker, though not specific, is a polyclonal elevated serum IgG4, and histological~     marker, currently held by several teams, is the presence within the inflammatory infiltrate,~     of a predominance of IgG4-expressing plasma-cells with a relative plasma-cells IgG4 + / IgG~     +> 50% on tissue immunostaining.~      The investigators project provides a global assessment of T lymphocyte abnormalities and~     specifically the TFH (Follicular Helper) during this IgG4-related disease compared to~     so-called groups control subjects suffering from Sjogren syndrome or healthy subjects.~   "
51021|NCT02899026|"~     Sirukumab is a human anti-IL-6 monoclonal antibody that selectively binds to the cytokine~     with high affinity that may have therapeutic benefit in the treatment of polymyalgia~     rheumatica (PMR) by interrupting multiple pathogenic pathways. Sirukumab inhibits~     IL-6-mediated signal transducer and activator of transcription 3 (STAT3) phosphorylation,~     resulting in the inhibition of the biological effect of IL-6. This study will evaluate the~     efficacy and safety of sirukumab to characterize the benefit-to-risk profile of sirukumab in~     the treatment of active PMR. The study will be conducted in 2 parts (Part A and Part B) and~     consists of the following phases: Screening phase, Part A: 52-week double-blind treatment~     phase, Part B: 52-week extension phase with no study drug administration and a 16-week~     follow-up phase if applicable.~      Approximately 150 subjects with a diagnosis of PMR and active disease within 6 weeks of~     baseline will be randomized into Part A, the 52-week double-blind treatment phase, to receive~     one of two doses of sirukumab or placebo, each in addition to a pre-specified prednisone~     taper. The efficacy and safety of sirukumab in sustaining remission will be assessed at Week~     52. Subjects completing Part A of the study who are in clinical remission will be eligible to~     enter Part B, the 52-week extension phase, designed to investigate the long-term maintenance~     of remission and safety following cessation of sirukumab treatment and to assess long-term~     corticosteroid use. Subjects will need to have follow-up safety evaluations for at least 16~     weeks after receiving the last dose of study drug, applicable for those who have withdrawn~     prematurely from the study or who have completed Part A but are not eligible for Part B.~   "
51022|NCT02899013|"~     The perianal lesions (LAP) specific for Crohn's disease have been reported in 1938, six years~     after the first cases of luminal disease. If phenotypic data of the latter are well~     documented today, those of perianal disease remain inadequately described. The reasons are~     numerous: understated symptoms by patients, elementary semiotics proctology ignored by~     practitioners, lack of validated classifications to track these violations and challenges to~     undertake clinical trials to high standard of proof in view of these variables, etc. ...~     Moreover, the impact of these LAP varies across studies (10-80%). in addition to the~     above-mentioned reasons, these results are also due to the different definitions of LAP used~     in the studies, their collection in reference centers versus tertiary centers, their~     potential occurrence at any time of disease progression, their greater frequency in case of~     distal disease (12% for infringement isolated ileal, 15% in breach ileo colic, 41% in case of~     colonic involvement and 91% in case of rectal involvement). Yet the specific LAP should be~     better documented because they are a factor of poor prognosis of Crohn's disease.~   "
51023|NCT02899000|"~     Demonstrate that a daily treatment regimen of adapalene 0.3%/benzoyl peroxide 2.5% gel + oral~     Doxycycline 200 mg is effective and safe in severe inflammatory acne with 3 or fewer nodules~     or cysts (non-nodulocystic) during a 12-week treatment period.~   "
51024|NCT02898987|"~     The objective of the Dataids cohort is to continue a long-term, prospective collection of~     clinical, laboratory and therapeutic data on a large cohort of HIV infected patients seeking~     care in 15 HIV centers in France in order :~        1. to provide and develop a surveillance system to describe clinical practice and temporal~          changes in the clinical course of HIV and HIV-related co-infections and co-morbidities~          in France.~        2. to assess the factors associated with the clinical, immunological and virological course~          of HIV infection and HIV-related co-infections and co-morbidities~      The specific objectives are as follows~        -  To continue surveillance of HIV infection in France to describe temporal changes~        -  To evaluate the efficacy of ART and factors associated with ART efficacy~        -  To monitor the uptake and outcome of HCV therapy~   "
51025|NCT02898974|"~     Medical marijuana is commonly prescribed people with Multiple Sclerosis (MS) for symptom,~     e.g. spasticity and pain, management. Unfortunately not much is known about its effects~     outside the treatment for these 2 symptoms. Several previous studies have suggested people~     with MS using medical marijuana have lower levels of physical disability and improved walking~     abilities. A major limitation of these previous studies is that the investigators used~     subjective measures of motor function. In this proposed observational case-control study the~     investigators plan to objectively measure multiple domains of motor function, such as:~     fatigue, strength, and walking ability. No marijuana will be brought on to campus or given to~     participants.~   "
51026|NCT02898961|"~     Low first-dose peak serum concentrations of amikacin and gentamicin are commonly reported in~     ICU patients. The present study aimed to assess whether 30 mg/kg amikacin or 8 mg/kg~     gentamicin achieved target concentrations in ICU patients with severe sepsis.~   "
51027|NCT02898948|"~     Levels of PCT (a marker of bacterial infection) are highest during sepsis: in fact, PCT is~     normally produced by the C cells in the thyroid gland. PCT was initially studied by Assicot1~     for distinguishing between bacterial meningitis and viral meningitis. The CALC-I gene codes~     for PCT. In the absence of infection, the extrathyroid mRNA expression of the CALC-I gene is~     repressed, and expression is restricted to neuroendocrine thyroid and pulmonary cells.~     Infection induces the ubiquitous expression of the CALC-I gene. PCT is not transformed into~     calcitonin in parenchymatous tissues. In a context of sepsis, the whole body acts as a~     neuroendocrine gland. Sepsis upregulates PCT mRNA expression much more than that of other~     cytokines.~      PCT is used in critical care departments as a diagnostic marker, a guide to treatment~     (antibiotics are withdrawn if the level falls) and a prognostic marker.~      There are few data on the diagnostic use of PCT in an internal medicine department. The~     available studies yielded contradictory results and only one prospective study has been~     performed . The objective was to study PCT in non-infectious, inflammatory pathologies and to~     establish whether PCT could distinguish infections from other inflammatory pathologies in~     patients in an internal medicine department. In a ROC curve analysis, a PCT threshold of 0.35~     µmol/l gave the greatest specificity (88%) and sensitivity (72%). Other studies have been~     performed but featured small sample sizes and a retrospective design.~      Of the various studies performed in internal medicine departments, none included patients~     presenting with a suspected bacterial infection (according to the clinician's interpretation)~     and lacking information on their bacterial status. In fact, these diagnoses are a core~     component of hospitalisation in internal medicine departments for fever or inflammatory~     syndrome. The investigators intend to include all patients, including those lacking~     information on their microbiological status).~   "
51028|NCT02898935|"~     Reconstruction software allows visualization of cortical structure in 3 dimensions, showing~     on a single picture the position of all the electrodes. The EEG signal of each recording plot~     of the electrode is analyzed and compared with the underlying brain structure reconstructed~     by the software. It is therefore possible to visualize 1) ictogenic and epileptogenic areas~     using neurophysiological stereoelectroencephalography (SEEG) data and 2) adjacent functional~     cortical areas with functional imaging and SEEG. Software makes it possible to determine the~     links between these areas. This study aims to show that using these software is an asset in~     surgical decision and in the choice of surgical strategy.~      Each patient has presurgical evaluation (usual care), including morphologic and (if~     necessary) functional MRI, EEG and SEEG. In this study, software will be used to analyze the~     processed data (FSL software, FMRIB laboratory, Oxford University and BrainVisa/Anatomist.~     The surgical decision will be taken according to the usual staff procedures, based on the~     usual examination results. After the decision making process, the staff will be asked to~     reconsider the surgical decision, according to the analysis provided by the software. The~     discrepancies between the decisions will be recorded.~   "
51029|NCT02898922|"~     Background Hepatitis B virus (HBV) co-infection in individuals with hepatitis C virus (HCV)~     can enhance the severity of hepatitis and the risks of liver cirrhosis and hepatocellular~     carcinoma (HCC). Hepatitis B vaccine is an effective measure to prevent HBV infection.~     Whether patients with HCV infection have non-protective antibody responses to hepatitis B~     vaccination more frequently than healthy subjects is still controversial and studies about~     cytokine response have been seldom reported.~      Methods Not-in-treatment patients with chronic HCV infection and 1:2 community/gender matched~     healthy control were obtained from a community-based screening. All participants received~     three doses of hepatitis B vaccine (20 μg HBsAg/ml/dose) on 0, 1 and 6 months schedule.~     Anti-HBs was tested 1 month after the third dose of vaccination and was compared between two~     groups. Spot-forming cells (SFCs) of interferon-γ (IFN-γ), interleukin-2 (IL-2),~     interleukin-4 (IL-4), interleukin-5 (IL-5) and interleukin-6 (IL-6) produced by lymphocyte~     were tested by enzyme-linked immunospot (ELISPOT) and were compared between two groups.~   "
54439|NCT02854384|"~     This work is intended to assess the effect of -30 minutes- exposure to mobile-phone on the~     functions of the central nervous system (CNS) in epileptic patients.~   "
51030|NCT02898909|"~     Femtosecond laser-assisted cataract surgery consists in nuclear lens fragmentation, followed~     by ultrasound phacoemulsification of nuclear lens, which is then removed.~      It can be assumed that fragmenting the nuclear lens in more pieces could facilitate the~     post-laser ultrasound phacoemulsification to extract the lens, with a lesser amount of~     ultrasonic energy.~      The decrease of ultrasonic energy delivered during cataract surgery is beneficial to the~     patient because it optimizes the vitality of corneal endothelial cells, which ensure corneal~     transparency.~   "
51031|NCT02898896|"~     HIV-infected patients with intermediate-high risk have a high prevalence of CAD and a~     substantial proportion of obstructive CAD. Degree of stenosis is associated with~     immunoactivation (lymphocyte and monocyte) and microbial translocation~   "
51032|NCT02898883|"~     The investigators study seeks to evaluate the feasibility and efficacy of a parent-focused,~     early intervention to prevent the development of chronic PTSD for children admitted to the~     emergency department for an acute traumatic injury and their parents. Furthermore, the~     investigators will identify potential risk factors for the development of PTSD and factors~     that influence treatment response. Finally, the investigators will prospectively measure~     trajectories of parental and child responses to trauma and their interaction over time. This~     study will bring together a multidisciplinary team across two major research universities~     (Case Western Reserve University and Kent State University) and a large pediatric trauma~     center (Akron Children's Hospital) in an effort to reduce rates of PTSD in children following~     traumatic injury.~   "
51033|NCT02898870|"~     The link between the products of synthetic chemistry and cancer is at the heart of much~     research. Recent work has identified the use of plant protection agents by farmers as a risk~     factor for developing non-Hodgkin lymphoma, including diffuse large B cell lymphoma (DLBCL)~     is the most common histology. Different biological models were used to understand the role of~     pesticides in lymphomagenesis. To summarize, most pesticides act at the cellular and~     molecular level, on different signaling pathways. After metabolized by cytochrome P450, these~     compounds generally become pro-oxidants. The increase in reactive oxygen species rate (SAR)~     causes the activation of signaling pathways involved in cell proliferation and survival. But~     deregulation of oxidative status does not in itself justify the specificity of the impact of~     pesticides on specific pathologies. Several agents have a genotoxic effect, others induce the~     activation of signaling pathways by binding to transcription factors and others have~     immunomodulating properties.~   "
51034|NCT02898857|"~     Every year in France, 30.000 deaths are due to lung cancer and 39.500 new cases of this~     disease are diagnosed (INCa 2014). Patients suffering from locally advanced non-small-cell~     lung cancer (NSCLC), stage IIIa, usually undergo a multimodality treatment including~     chemotherapy with platinum compounds before surgery (called neoadjuvant chemotherapy or~     induction chemotherapy). The reason of this combined modality treatment is the really poor~     prognosis of patients presenting a disease already spread to lymph nodes (classified N2 when~     the lymph node under the carina is affected). Up till now, the five-year survival of patients~     who underwent surgical resection of N2 NSCLC does not exceed 15%~   "
51035|NCT02898844|"~     This study examined how dieting with a partner affects weight loss, diet adherence,~     psychological well-being, and cortisol.~   "
51036|NCT02898831|"~     This study will be a prospective randomized controlled trial comparing cold compression to no~     intervention immediately prior to and during intrauterine device insertion. Subjects will be~     randomized to cold compress or no intervention (standard practice in our clinics). Following~     IUD insertion they will complete a validated pain scale survey regarding their pre-procedure~     and intra-procedure pain.~   "
51037|NCT02898818|"~     To study the vaginal and oral microbiome by swab samples. On selected cases, also papa smear~     will be studied.~   "
51038|NCT02898805|"~     The study is designed to compare the effects of two combination of nutraceuticals: Armolipid~     Plus® and LopiGLIK® (Akademy Pharma), a new supplement that, in addition to Berberine and Red~     Rice, contains Morus Alba's extract. The study will analyze the impact of 16 week treatment~     with one of the combinations, according to a randomized scheme, on metabolic parameters in~     dyslipidemic subjects that do not require or not tolerate a statin therapy. In particular, it~     will assess the ability of the two combinations to reduce the levels of total and LDL~     cholesterol, HbA1C, glicaemia and insulin and increase those of HDL cholesterol.~   "
51039|NCT02898792|"~     Obstructive Sleep Apnea (OSA) is the most common problem that affects sleep. People with this~     problem have their airway blocked or minimized, causing snoring or gasping while sleeping. It~     can also reduce the amount of oxygen that circulates in the blood of people affected by it.~     Millions of Americans have OSA; 10% of adults have diagnosed OSA, an estimated 25% have~     undiagnosed OSA. There is concern in the medical community about how to manage pain in~     patients with OSA because of the risk of decreased or slower breathing associated with~     certain pain medications called opioids. Giving OSA patients opioids could cause them to have~     even lower oxygen amounts in their blood stream. It is conceivable that patients with OSA may~     require lower doses of opioids to cause decreased breathing as compared to patients without~     OSA, however this has not been proven. In this study, we are using a very short acting and~     easily reversible opioid pain medication called remifentanil in patients with OSA in order to~     find out if treated and untreated OSA patients respond to opioid differently than patients~     without OSA.~   "
51040|NCT02898779|"~     To investigate the comparative tolerability, metabolism and pharmacokinetics of individual~     enantiomers of PQ in healthy human volunteers. The specific aim is the comparative evaluation~     of the metabolism, pharmacokinetic behavior, and tolerability of the isomers of PQ (RPQ and~     SPQ and the racemic mixture RSPQ) in normal healthy human volunteers.~   "
51041|NCT02898766|"~     This will be a randomized, cross-over design. Subjects will be randomized to one of two~     interventions on two separate study days, 1 week apart.~   "
51042|NCT02898753|"~     Phase I/II study enrolling up to 12 patients in a twelve-month, Open-label, Randomized,~     Parallel Active Control, Single and Repeat Dose, Dose-escalation Study of the Safety,~     Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) and Preliminary Efficacy of~     VAL-1221 Delivered Intravenously (IV) in Ambulatory and Ventilator-free Patients with~     Late-Onset GSD-II (Pompe Disease) Study~   "
51043|NCT02898740|"~     This project is investigating whether a home-based exercise program will reduce depression in~     patients with Parkinson's disease.~   "
51045|NCT02898714|"~     On the first of July 2016, the Freestyle Libre Flash Glucose Monitor (FGM) will be reimbursed~     in Belgium by means of a new diabetes reimbursement program for adults. For children, the~     Freestyle Libre FGM is also reimbursed by means of a new reimbursement program from the first~     of August 2016 onwards. Making this the only way to receive the device in Belgium. To~     understand the impact of this new FGM on diabetes patients in UZ Leuven and OLVZ Aalst, we~     want to study the use of the device by our patients by means of an observational study where~     patients complete questionnaires at regular time points in the first year of usage and after~     24 months Clinical data will be gathered during the routine clinical visits as part of the~     reimbursement program.~   "
51046|NCT02898701|"~     This study contains two pilot studies: 1) one study will investigate practice dosage of a~     postural stepping task in healthy young individuals in order to determine an operational~     definition of performance plateau, and 2) the other study will investigate whether practicing~     beyond reaching a performance plateau improves learning of a postural stepping task in~     healthy older adults, compared to discontinuing practice immediately after reaching a~     performance plateau. The investigators hypothesize that the group that continues to practice~     beyond reaching their performance plateau will learn and retain the motor task better than~     the other group.~   "
51047|NCT02898688|"~     This study will address vaccine uptake both for pregnant women and for their children,~     through 20 months of age, to test the hypothesis that exposure to the P3+ intervention~     package will increase the likelihood a pregnant woman gets herself vaccinated against~     influenza and pertussis before delivery and get her child vaccinated on time. This study~     builds off of a prior intervention, developed by Emory, at the practice, provider, and~     patient levels (P3) to develop, implement and evaluate an enhanced intervention (P3+) to~     improve vaccination uptake among pregnant women, and later, their children.~   "
51048|NCT02898675|"~     Platelet rich fibrin is a second generation platelet concentration which contains various~     growth factors. The aim of this study is to evaluate the clinical and biochemical efficacy of~     PRF in subjects of chronic periodontitis in the operation of conventional periodontal flap.~   "
51049|NCT02898662|"~     Ph2a study planned to be run at approximately 16-18 sites in 4 EU countries (Denmark,~     Hungary, Poland and Sweden) enrolling approximately 170 patients to ensure 70 randomized~     patients with eosinophilic, moderate to severe asthma. The patients will receive 13 once~     weekly inhaled doses of the study drug. Treatment is initiated on top of their ICS/LABA~     controller medication, which is then tapered down and withdrawn during a period of 3 weeks~     and during the last 3 weeks of treatment the study drug is given as monotherapy. SABA is used~     as reliever medication during the whole study period. Primary endpoint is Loss of asthma~     control. When the endpoint is met, patients will resume their ICS/LABA, will be followed for~     an additional 4 weeks and will thereafter discontinue the study.~   "
51050|NCT02898649|"~     Pancreatic cancer is 5th leading cause of cancer-related death in Korea. It has a dismal~     prognosis with very low 5-year survival rate, about 5%. Only 10% of pancreatic cancer~     patients is diagnosed in operable status. So, most of patients could not be treated with~     curative resection.~      Locally advanced pancreatic cancer (LAPC) is defined by defined as surgically unresectable~     due to vascular encasement (e.g. celiac trunk or superior mesenteric artery) by tumor, but~     have no evidence of distant metastases. In LAPC patients, systemic chemotherapy with/without~     radiotherapy was used as a standard therapy, but therapeutic response was very poor. Only~     less than 30% of patients showed treatment response, and median survival of LAPC patient was~     only 9 months. Thus, more effective treatment modality is needed for LAPC patients.~      Irreversible electroporation (IRE) is a soft tissue ablation technique using ultra short but~     strong electrical fields to create permanent and hence lethal nanopores in the cell membrane,~     to disrupt the cellular homeostasis. IRE does not cause thermally induced necrosis and has~     tissue selectivity, so adjacent tissue or vascular structures can be preserved.~      Several clinical trials using IRE were performed to liver, kidney or lung cancer patients. We~     will operate IRE procedure to LAPC patients who were previously received standard therapy but~     showed no response, using NanoKnife IRE device. We will investigate treatment response and~     safety of IRE.~   "
51051|NCT02898636|"~     Identify the cytokine or combination of cytokines, with the best diagnostic performance to~     characterize the vital nature of a skin wound in the body.~   "
51052|NCT02898623|"~     TB remains a health problem in France with about 5,000 new cases per year. Development of new~     screening tests is a priority for TB. The main objective of the study is to evaluate~     performances of innovative blood tests to identify active tuberculosis in adults patients~     living in low-prevalence country. Adult patients with possible TB from will be tested for the~     presence of antibodies directed against M. tuberculosis selected antigens. Positive and~     negative predictive values will be established based on TB culture results.~   "
51053|NCT02898610|"~     This study evaluates the use of Colchicine in adults over 40 years of age who have suffered~     an ischaemic stroke or transient ischaemic attack NOT caused by cardiac embolism or other~     defined causes. Patients will be randomised to 0.5 mg/day of Colchicine plus usual care, or~     to usual care alone.~      To investigate the efficacy of low dose colchicine (0.5mg/day) plus usual care (defined as~     antiplatelet, lipid-lowering, antihypertensive treatment, and appropriate lifestyle advice)~     compared with usual care alone to prevent non-fatal recurrent ischaemic stroke, myocardial~     infarction, cardiac arrest, hospitalization for unstable angina and vascular death after~     ischaemic stroke or transient ischaemic attack (TIA) not caused by cardiac embolism or other~     defined causes unrelated to atherosclerosis~   "
51054|NCT02898597|"~     As people with HIV/AIDS live longer, the burden of non-AIDS-related health problems such as~     cardiovascular diseases and cancers on these people have consistently increased. Smoking is~     one of the major contributing factors to these health problems and rates of cigarette smoking~     in this group are substantially higher than those of the general population: 40-70% vs.~     17-10%. Especially, women living with HIV/AIDS seem to be more susceptible to the negative~     consequence of smoking than their male counterparts. They are also less likely to see tobacco~     dependence treatment for dual stigma associated with both conditions: HIV infection and~     nicotine addiction. This is a pilot study to develop smoking cessation intervention for these~     women.~   "
51966|NCT02886715|"~     A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing~     Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both Active Treatments to a~     Vehicle Control in the Treatment of Acne Vulgaris~   "
51056|NCT02898571|"~     The aim of this project is to measure the differences in antioxidant capacity at different~     time points after consuming a single dose of antioxidant-containing drink (vitamin C or~     epicatechin) compared with a control drink in 10 volunteers, and then match the data with the~     proposed modelling corresponding to either homeostasis or accumulation. Additionally it will~     also determine whether the effect on changes of antioxidant capacity in response to~     epicatechin and vitamin c is equal.~   "
51057|NCT02898558|"~     This study explores the possible implications of the increase in perceived body size for~     rehabilitation of motor functions. In a recent study we have tested if motor abilities of~     patients with stroke improve wearing magnifying lenses, showing that a beneficial effect of~     magnifying lenses can be observed in some patients. In the present study, we will identify 12~     patients from this cohort who demonstrated an improvement greater than 10% in one or two~     motor task when wearing magnifying glasses. These participants will be invited to take part~     in a clinical study in which they will undergo a training phase: subjects will wear~     magnifying lenses at home for 30 minutes daily for 14 days while completing a jigsaw puzzle;~     a log will be kept to document participation. Participants' performance on different motor~     tasks will be assessed before, immediately after and 1 month after the training session.~     Standardized measures of motor performance will include the the Action Research Arm test and~     the Rivermead Assessment of Somatosensory Performance (RASP). In addition, participants will~     undergo grip strength, finger tapping tasks and a reaching and grasping task. We expect the~     repeated use of magnifying lenses to generate an improvement of patients' performance across~     tasks and this effect to be persistent in time.~   "
51058|NCT02898545|"~     This study will evaluate the recurrence rates of atrial fibrillation that develops in the~     hospital following non cardiac procedures or surgeries or acute medical illnesses.~   "
51059|NCT02898532|"~     Practising target shooting sport requires focused attention and motoric steadiness. Parental~     reports suggest that children with attention-deficit/hyperactivity disorder (ADHD) benefit~     from participating in target shooting sport in Danish Shooting Associations.~      Aim: This study aims at examining if and to which extent target shooting sport in children~     with attention difficulties reduces parent- and teacher-reported severity of inattentiveness,~     hyperactivity, and impulsivity, and improves the children's well-being and quality of life.~   "
51060|NCT02898519|"~     Leptospirosis is a zoonotic infection induced by pathogen bacteria (genus: Leptospira)~     growing in water polluted by animal fluids. Due to its 10 fold occurence in French overseas~     aera, and especially in Reunion Island, as compared to metropoly, it is considered as a major~     public health issue.~      An important inter-individual variability in humoral immune response suggests that~     vaccination should be recommended in exposed subjects.~      This cohort study aimed to determine if subjects that have been infected by leptospirosis for~     1 to 7 years still remain immunized, and then do not need vaccination.~   "
51061|NCT02898506|"~     The objective of the trial is to study whether daily treatment with liraglutide improves~     endogenous insulin secretion, postpones progression to overt Type 1 diabetes, and is~     tolerable and safe in subjects aged 10-30 years, who are positive for multiple islet~     autoantibodies and have dysglycemia.~   "
51062|NCT02898493|"~     The evaluation of quality of life in health is particularly important for measuring the~     impact of the chronic diseases. The scales of measure constitute the main measurement tool in~     clinical trials because of their psychometrics properties and of their ease of use.~      Among these scales, the 36-Item Short Form Survey (SF-36) and the EuroQol five dimensions~     questionnaire ( EQ-5D) were widely validated in various populations, of which the population~     of the diabetics patients. Both scales have validated versions in French.~      In the Antilles and in Reunion Island, diabetes is a frequent pathology and is the subject of~     many clinical and epidemiological trials. One of the difficulties encountered during the~     implementation of these studies is the absence of measurement tools validated for these~     populations.~      Investigators thus suggest, within a common workgroup uniting Guadeloupe, Martinique and~     Reunion Island, adapting and validating these scales according to an identical procedure in~     Creole from Guadeloupe, from Martinique and from Reunion Island and validating the French~     versions of these scales in their populations of type II diabetics patients.~   "
51063|NCT02898480|"~     Remote ischemic conditioning (RIC) is a therapeutic strategy for protecting organs or tissue~     against the detrimental effects of acute ischemia-reperfusion injury. It remains unknown~     whether this can be used in retinal vascular occlusive diseases. The purpose of the present~     study is to examine whether the autoregulation of retinal vessel diameters in normal persons~     change after remote ischemic conditioning.~   "
51064|NCT02898467|"~     Intraplaque hemorrhage is the driving force of atherothrombotic plaque vulnerability to~     rupture and associated clinical complications. Polymorphonuclear neutrophils (PMNs) represent~     about 70% of leukocytes and may constitute a source of proteases and oxidants that favour~     plaque rupture. Our objective is to evaluate PMN activation in atherosclerotic plaque of~     non-diabetic versus type 2 diabetic patients. For this purpose, investigators will quantify~     the presence of cell-free DNA, that reflect the formation of neutrophil extracellular traps~     (NETs) in carotid endarterectomy samples.~   "
51083|NCT02898220|"~     The Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network~     has been established by the National Institute of Diabetes and Digestive and Kidney Diseases~     (NIDDK) of the National Institutes of Health (NIH) to focus on a broader approach to the~     study of Interstitial Cystitis (IC)/ Bladder Pain Syndrome (BPS) in men and women, and~     Chronic Prostatitis (CP)/Chronic Pelvic Pain Syndrome (CPPS) in men, than previously~     undertaken. Patients with IC or CP are being recruited for a new study called the Trans-MAPP~     Study of Urologic Chronic Pelvic Pain: Symptom Patterns Study (SPS). This research study will~     recruit Control Participants to better understand the symptoms of individuals with some form~     of IC or CP. As with many chronic pain disorders, IC and CP are poorly understood, and~     treatment is often not helpful. The goal of this study is to better understand how pain is~     felt in people with IC or CP and the investigators hope that this study will lead to~     improvement in the treatment of IC and CP.~   "
51414|NCT02893917|"~     This randomized phase II trial studies how well olaparib with or without cediranib works in~     treating patients with castration-resistant prostate cancer that has spread to other places~     in the body. Olaparib and cediranib may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth.~   "
51065|NCT02898454|"~     Primary Objective:~      To evaluate the efficacy of dupilumab compared to placebo on a background of mometasone~     furoate nasal spray (MFNS) in reducing nasal congestion/obstruction (NC) severity and~     endoscopic nasal polyposis score (NPS) in patients with bilateral nasal polyposis (NP). In~     addition for Japan, reduction in computed tomography (CT) scan opacification of the sinuses~     will be also a co-primary objective.~      Secondary Objectives:~        -  To evaluate the efficacy of dupilumab in improving total symptoms score (TSS).~        -  To evaluate the efficacy of dupilumab in improving sense of smell.~        -  To evaluate the efficacy of dupilumab in reducing CT scan opacification of the sinuses~          (Primary objective for Japan).~        -  To evaluate ability of dupilumab in reducing proportion of patients requiring treatment~          with oral corticosteroids or NP surgery.~        -  To evaluate the effect of dupilumab on patient reported outcomes and health related~          quality of life outcome by sinonasal outcome test-22 (SNOT-22).~        -  To evaluate efficacy with various regimen.~        -  To evaluate the effect of dupilumab in the subgroups of patients with prior surgery and~          co-morbid asthma (including non-steroid antiinflammatory drug [NSAID] exacerbated~          respiratory disease [NERD]).~        -  To evaluate the safety of dupilumab in patients with bilateral NP.~        -  To evaluate functional dupilumab concentrations (systemic exposure) and incidence of~          treatment-emergent anti-drug antibodies (ADA).~   "
51066|NCT02898441|"~     The present study is a randomized controlled trial of LDCT screening for lung cancer versus~     usual care. 6000 high-risk subjects (age 45-70) were recruited and randomized to the Active~     arm (Baseline + 2 biennial repeated LDCT screening) or to the Passive arm, followed up in~     usual care (Baseline + 2 biennial repeated questionnaire inquiries). Follow-up for lung~     cancer incidence, lung cancer mortality and overall mortality was performed. Blood samples~     were stored from the Active arm in a Biobank. Management of positive screening test was~     carried out by a pre-specified protocol.~   "
51067|NCT02898428|"~     With appropriate day-time carbohydrate intake and insulin dose, the 24 hour glucose levels~     and prevalence of night-time hypoglycaemia are comparable in breastfeeding new mothers and~     formula feeding new mothers with type 1 diabetes at the second after delivery diabetes~     control compared with the first after delivery diabetes control at Steno Diabetes Center.~   "
51068|NCT02898415|"~     Liver transplantation (LT) is one of the curative treatment options for patients with HCC~     associated to chronic liver disease (cirrhosis). All current international guidelines~     recommend LT for HCC only within pre-defined criteria The use of restrictive criteria to~     select patients affected by HCC for LT was originally proposed with the Milan criteria. These~     criteria were based on pathologic assessment of number and size of the HCC nodules on the~     explanted liver. Subsequently, many authors proposed the expansion of such restrictive~     criteria (e.g. UCSF, Tumour Volume, Up-To-Seven etc.). All these attempts, based on different~     combinations of morphologic parameters, have been defined on the pathologic staging of the~     tumor made on the removed liver, namely after LT, once decision on treatment and treatment~     itself could not be changed Although post-LT pathology / pre-LT radiology correlation have~     improved over time, significant biases still affect clinical assessment of HCC stage and no~     reliable protocols has entered clinical practice yet. In addition, robust evidence indicates~     that other biological markers of aggressiveness (such as α-Fetoprotein levels and clinical~     response to bridge therapies) have to be added when evaluating pre-operative variable~     Although many studies have been conducted, prognostic calculators of cancer-specific survival~     for HCC patients undergoing an evaluation for LT are not yet available. Such models should be~     able to provide survival estimates based on pre-treatment oncologic variables.~      The main goal of the study is the definition of a cancer-specific prognostic model based on~     pre-operative features (radiologic staging and α-Fetoprotein levels) of a wide population of~     patients who underwent LT for HCC.~      Considering the competitive risk of cancer-specific mortality and death due to other causes,~     the investigators aim to redefine the Up-To-Seven criteria, as they were developed on the~     base of pathologic staging~   "
51069|NCT02898402|"~     Emergent and infectious diseases are a public health priority on Reunion Island. Amongst~     public health threats, the infection due to Coxiella burnetii (Q fever) seems to have~     appeared on Reunion island in 2007 with two hospitalised confirmed cases (one death) and one~     probable case with a goat farmer.~      According to the investigator, the diffusion of C. burnetti is more ancient and such~     diagnosis have been made in the last 30 years with 80 positive serologies identified between~     2005 and 2011.~      Considering the high epidemic power of this disease, its often silent clinical expression and~     its life-threatening condition, the principal investigator wishes to perform a~     sero-epidemiological study in order to establish or to reject the risk of emergence of Q~     fever in Reunion island.~      The study will be performed on pregnant women because Q fever is responsible for particular~     complications during pregnancy and because the number of pregnancy followed on Reunion island~     is stable from one year to the other. The pregnant women population presenting the same~     exposure criteria as the general population, this population will be used to extrapolate to~     the general population of the island.~   "
51070|NCT02898389|"~     The primary objective of this study is to show that cardiovascular risk factors associated~     with the chronic elevation of arterial resistance may be associated with false profiles of~     intracranial hypertension during transcranial doppler ultrasound of the middle cerebral~     arteries in intensive care unit patients. A false profile of intracranial hypertension is~     defined by a high pulsatility index without any intracranial pathology.~   "
51071|NCT02898376|"~     This study evaluates the dermatological life quality six months after spa cares in patients~     with severe late toxicity involving the skin and / or soft tissues after postoperative~     radiotherapy for breast cancer. Half of the patients will be treated with a combination of~     pentoxifylline (PTX) and alpha-tocopherol (Vit E) when Half of the patients will receive~     skin-oriented spa cares in addition.~   "
51072|NCT02898363|"~     Context People with intellectual disability (PWIDs), nearly 1,300,000 adults and children in~     France, develop as many cancers as persons in the general population. However, their tumors~     are different by their particular organ distribution, the age of onset, the biological~     background (2,000 genetic conditions are associated with an intellectual disability) and~     above all the unusual clinical presentation. These cancers are not well known from~     physicians, carers and families, and often discovered late. A recent review of the literature~     shows many inequalities in the prevention, monitoring, screening, diagnosis and treatment of~     cancer in these patients. Currently, no population study on clinical features and stage at~     diagnosis of cancer in PWIDs is available. No interventional research study has been~     conducted on this subject.~      Hypothesis Investigators hypothesize that inequalities in cancer care of PWIDs do not result~     from a direct link between intellectual disability and cancer, but are related to diagnosis~     difficulties of these tumors which are not well known, and to difficulties of communication~     with these patients who do not express easily their symptoms, particularly pain.~   "
51075|NCT02898324|"~     Bullying is a major problem worldwide and, with no exception, in Chile. Bullying is defined~     as a systematic aggressive behavior against a victim who cannot defend himself or herself.~     Victims suffer many consequences such as social isolation, psychological maladjustment, and~     self-injury behavior. Additionally, bullies have a higher risk for conduct problems and~     substance use disorders. These problems appear to last in time, affecting mental health even~     years later since the experience of bullying.~      There are few studies in Chile aiming to determine the prevalence of bullying. In one of such~     studies, 47% of the students reported having been bullied during the last month before the~     application of the questionnaire. Even though there are many initiatives and guidelines in~     Chile supported by the government to help schools in order to deal with bullying, there is no~     any cluster randomized controlled trial (RCT) aiming to assess the effectiveness of an~     anti-bullying program.~      KiVa anti-bullying prevention program contains universal and indicated actions. Main~     universal actions for 5 to 6 graders consist of 10 two-hours lessons given during a year and~     an online game, which have the aim to raise awareness of the role of the group in bullying,~     increase empathy and promote strategies to support victims. Indicated actions consist of a~     set of discussion groups with the victims and with the bullies with proper follow-up.~      The aims of this study are: 1) To develop a culturally appropriate version of the Kiva~     material, and 2) to test its effectiveness of KiVa program with and without the online game,~     to reduce bullying behavior among low-income primary schools in Santiago using a cluster RCT~     design with three arms: i) KiVa full program group, ii) KiVa without online game program~     group, and iii) Control group.~   "
51076|NCT02898311|"~     This study evaluates the success rate, as the biological and prosthesis complications, of~     posterior single-unit implants immediately loaded with a chair side Computer-Aided Design and~     Manufacturing (CAD-CAM) composite crown, after a follow-up period of 6 months,1,2,3,4 and 5~     years.~      Complementary ex vivo analyses will be performed to evaluate the wear of restorations. The~     time and cost benefit of the presented digital workflow, as patient centered outcomes will~     also be evaluated.~   "
51077|NCT02898298|"~     The purpose of this study is to evaluate the efficacy of a novel positive emotion regulation~     intervention that aims to increase positive emotions and improve emotion regulation skills in~     children, adolescents and young adults. The study focuses on individuals with a developmental~     disorder such as Autism Spectrum Disorder and other Learning or Developmental Disabilities in~     comparison to typically developing (TD) controls. Participants will complete a~     psycho-educative training to learn about positive emotions and how to increase them in their~     daily lives. Participants are expected to benefit from the training, which will be evident in~     a change in emotion experience, emotion regulation strategy use, and well-being. Emotion~     regulation efficacy will be related to symptom severity (autistic symptoms), alexithymia and~     problematic behaviors.~   "
51078|NCT02898285|"~     The primary objective of this investigation is to test the efficacy of two sport~     participation formats (individual sport, team sport) on key psychosocial outcomes compared to~     a non-sport condition among parents of young children who were not participating in sport at~     baseline of the study.~      Research of this type is important because parents represent a group dealing with numerous~     challenges and this is a period of time shown to have the greatest decline in physical~     activity. Furthermore, parents could reap great benefits in psychological health through the~     increase in physical activity and sport participation.~      It is hypothesized that participation will be predicted by sports commitment as per the~     tenets of the Sport Commitment Model, and commitment will be predicted primarily by enjoyment~     (+), social constraints from family obligations/involvement alternatives (-), followed by~     social involvement opportunities/personal investments (+).~   "
51079|NCT02898272|"~     The SCCOR Minorities study will recruit minority participants from the COPDGene cohort, in~     whom the University of Pittsburgh has already obtained baseline and five year data, in order~     to enhance bone mineral density and vascular function data collection from minority smokers.~     Dual X-ray absorptiometry (DXA) scans will be obtained to measure bone mineral density.~     Non-invasive vascular studies will be performed to measure endothelial function.~     Questionnaires regarding symptoms and activity levels will be administered and a blood sample~     will be obtained in participants in which blood samples are not already available from the~     COPDGene study visits.~   "
51080|NCT02898259|"~     A Phase IB/II Trial of Lenalidomide (Revlimid®), Ixazomib and Rituximab (RIXAR) as Front-line~     Therapy for High Risk Indolent B cell Lymphoma~   "
51081|NCT02898246|"~     The aim of the study is to evaluate the psychometric properties of the newly developed Fear~     of Activity in Situations - Heart Failure (FActS-HF 15) scale. The FActS-HF 15 is a~     questionnaire assessing fear of physical activity (fear of movement) in patients with chronic~     heart failure. FActS-HF 15 assesses cognitions and emotions that can occur during physical~     activity, independent of avoidance behavior. Firstly, the study aims at evaluating the~     instrument's reliability and validity and to investigate associations of fear of physical~     activity with demographic, medical, and psychosocial patient characteristics. Secondly, the~     study aims at assessing everyday physical activity using accelerometric measures to test the~     hypothesis that fear of physical activity in patients with heart failure is related with~     lower actual physical activity.~   "
51082|NCT02898233|"~     The purpose of this study is to better understand how low-level light therapy (LLLT) can be~     used to augment the antidepressant effects of Deprexis, an internet-based treatment program~     for depression, for participants with current major depressive disorder. The researchers will~     administer active and placebo LLLT to the right forehead of participants who show an~     improvement of at least 10% in depressive symptoms from baseline after two weeks of Deprexis~     treatment.~      Hypothesis: Participants who receive active LLLT will show a greater reduction of depressive~     symptoms than participants who receive placebo LLLT.~   "
51084|NCT02898207|"~     This phase I trial studies the side effects and best dose of olaparib and onalespib when~     given together in treating patients with solid tumors that have spread to other places in the~     body or cannot be removed by surgery or ovarian, fallopian tube, primary peritoneal, or~     triple-negative breast cancer that has come back. Olaparib and onalespib may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth.~   "
51967|NCT02886702|"~     A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing~     Tazarotene Cream 0.05% to TAZORAC® (tazarotene) Cream 0.05% and Both Active Treatments to a~     Vehicle Control in the Treatment of Stable Plaque Psoriasis~   "
51085|NCT02898194|"~     Background:~      Some people cannot make medical treatment decisions on their own. The people who make~     decisions on their behalf are called medical surrogates. Sometimes surrogates cannot predict~     which treatment course the person or their loved ones would have chosen. The surrogates often~     become distressed because of making these decisions. Researchers think a tool called a~     Patient Preference Predictor (PPP) may be able to make the process easier. The PPP would~     predict what treatment the person would want. This is based on treatment preferences of~     similar people in a similar circumstance. Researchers want to interview surrogates to explore~     their views on the PPP.~      Objective:~      To explore surrogates views on incorporating a PPP into shared medical decision-making.~      Eligibility:~      People 18 years or older who:~      Have acted as a surrogate medical decision-maker within the past 3 years. This includes~     decisions about~      treatment, medication, hospice care, hospital admission, or discharge.~      Are not pregnant~      Design:~      Participants will be screened by meeting with clinicians in person or by phone to discuss the~     study.~      Participants will take part in a focus group. This is a small group of people discussing~     their thoughts and opinions. This will last for about 2 hours.~      Participants will be served a light meal.~      Participants will provide information about themselves and their views. They will talk about~     their past experiences making medical decisions for someone. They will discuss how they felt~     about these decisions.~      The PPP will be explained to participants. They will give their views on it.~      The research team will audio record the focus group and take notes.~      Participants will fill out questionnaires.~   "
51086|NCT02898181|"~     Acute Decompensated Heart Failure (ADHF) is a major cause of morbidity and mortality. It is~     associated with increased systemic inflammation. Previous studies have demonstrated increased~     levels of cytokines such as C-reactive protein (CRP), interleukin-1 (IL-1), interleukin-6~     (IL-6), interleukin-10 (IL-10) and Tumor Necrosis Factor alpha (TNFα) in patients with heart~     failure (HF). Increased activity of sympathetic nervous system in ADHF is linked to~     inflammation. Previous anti-inflammatory drug therapies in HF have demonstrated no~     significant impact on cardiovascular outcomes. Low-level vagus nerve stimulation (LLVNS) is a~     non-invasive way to modulate autonomic tone and thereby inflammation. Vagal nerve stimulation~     is thought to increase the parasympathetic activity and suppress the sympathetic activity.~     Clinical studies of vagal stimulation in chronic HF have been negative. Recent experimental~     and clinical data suggest that low level tragus nerve stimulation (LLTNS) may produce the~     same desired neuromodulator effect compared to LLVNS. It is however unknown if LLTNS in ADHF~     will directly lead to a reduction in the levels of pro-inflammatory cytokines (CRP, IL-1,~     IL-6 and TNF-α) and an increase in the level of anti-inflammatory marker IL-10.The objective~     of this proposal is to determine the impact of LLTS on inflammatory cytokines in patients~     with ADHF.~      Patients will be randomized to either active or no stimulation(~8 hours daily). Serum~     collected will (post admission and on days 2, 3 and 4 post admission) will be used for~     cytokine measurement. This investigation will likely establish the first evidence of effects~     of LLTS on suppression of inflammation in patients presenting with ADHF.~   "
51087|NCT02898168|"~     Among the sequelae of stroke, gait disorder is directly linked to the degree of autonomy in~     the daily life of patients. It is considered significant effects on their Quality of~     Life(QOL).~      Further methods of rehabilitation are required for convalescent patients to recover their~     function soon and better, due to a multitudes of recovery patient with troubles such as gait~     problem.~      This trial is studying to investigate the effects of gait training with a functional~     electrical stimulation (FES) `WalkAide[R](WA)' to improve the lower-limb function and~     ambulation in convalescent stroke patients.~   "
51088|NCT02898155|"~     Potentially Avoidable Hospitalizations (Pah) Are Studied As An Indirect Measure Of Access To~     Primary Care And Of The Interface Between Primary And Secondary Care. A Previous Work Unveils~     Considerable Geographic Variation In The Rate Of Pah In France And Suggest That Primary Care~     Organization Might Play A Role In This Variation. However, A Limitation Of This Work Lies In~     The Lack Of Data On Actual Primary Care Utilization.~      The Aim Of This Study Is To Analyze The Role Of Primary Care In The Variation Of Potentially~     Avoidable Hospitalizations At the Zip Code Level, In The French Region~     Languedoc-Roussillon-Midi-Pyrénées.~      The investigator will implement An Ecological Approach In Which The Geographic Variation In~     The Rate Of Pah Is Analyzed In The French Region Lrmp, Year 2014. Age- And Sex-Adjusted Rate~     Of Pah By Zip Codes (N=612) Is Modeled Using A Spatial Regression Model.~   "
51089|NCT02898142|"~     Fasting and postprandial hypertriglyceridemia (HTG) depends on increased production of~     intestinal triglyceride rich lipoproteins in patients with isolated fasting~     hypertriglyceridemia.~      The objective of this study is to compare the serum apoB48 rate after a standardized load~     test, among patients with isolated hypertriglyceridemia and patients with metabolic syndrome.~   "
51090|NCT02898129|"~     The research question is Are the different types of house in Ho Chi Minh city equally~     contributing to chronic respiratory diseases?.~      According to this question, a cross-sectional and explorative study was set up to explore the~     differences in the environmental characteristics and prevalence of chronic respiratory~     diseases among common housing types in Ho Chi Minh city. Preliminary work was performed in~     100 houses (20 houses per type, included tube houses, rental houses, rural houses, slum and~     apartment) from November 2013 to June 2015. It included measures by environmental devices,~     questionnaires and indoor activities diaries.~      This study will aim to collect information about the prevalence of chronic respiratory~     diseases (CRDs) inside those house types to understand more about role of house types in~     developing CRDs.~      The objective is:~        1. to evaluate the relationships between the type of house and lung function of inhabitants~          in each housing type.~        2. to evaluate the effects of environmental risk factors in each house type on prevalence~          of CRDs~   "
51091|NCT02898116|"~     This is an open-label, multicenter, single-arm study to evaluate the safety and preliminary~     efficacy of a targeted therapy for NSCLC in combination with a checkpoint inhibitor:~        -  Ensartinib (X-396), an anaplastic lymphoma kinase (ALK) Inhibitor and~        -  Durvalumab (MEDI4736), an anti-programmed cell death ligand 1 (PD-L1) antibody.~   "
51113|NCT02897830|"~     Open-label study to evaluate the safety and efficacy of Ixazomib in combination with~     Lenalidomide and Dexamethasone in patients with newly diagnosed multiple myeloma (MM). The~     patient population will consist of adult men and women up to 65 years, who have a confirmed~     diagnosis of MM who meet eligibility criteria.~   "
51092|NCT02898103|"~     The moderate-to-severe pain many patients experience following orthopedic surgery is often~     treated with opioids, which are associated with side effects such as nausea/vomiting,~     sedation, and respiratory depression (and a risk of abuse). Potent site-specific analgesia~     with fewer side effects may be provided with a continuous peripheral nerve block, which~     involves the percutaneous insertion of a catheter adjacent to the peripheral nerve(s)~     supplying a surgical site. Local anesthetic is introduced via the catheter. However, there~     are major problems with continuous nerve blocks that have dramatically limited their use~     outside academic centers. Percutaneous peripheral nerve stimulation (PNS) or nerve~     modulation is an alternative method of pain control involving the insertion of an electrical~     lead through an introducing needle—obviating an open surgical incision for placement—followed~     by the introduction of electric current to produce analgesia. This modality has been used to~     treat chronic pain, but it has not been evaluated with a randomized, controlled study when~     applied to acute pain management (post-surgical analgesia). This temporary therapy has~     multiple theoretical benefits over existing analgesics, such as a lack of systemic side~     effects (e.g., nausea, respiratory depression), an absence of induced muscle weakness, and a~     reduced risk of adverse events (e.g. infection). The purpose of the proposed randomized,~     double-masked, placebo-controlled, crossover, feasibility study is to explore the possibility~     of treating postoperative pain with ultrasound-guided percutaneous PNS and, if so, to help~     power a subsequent definitive randomized, controlled trial.~   "
51093|NCT02898090|"~     This research focuses on the development and validation of indicators on the appropriateness~     of oral anticoagulant prescriptions. The investigators want to propose transferable tools to~     other healthcare institutions to allow automated construction of indicators as part of a~     structured approach to improve future practices. The main objective of the study is to~     develop indicators on the appropriateness of oral anticoagulant prescriptions in adult~     medicine automated from the hospital information system and to assess their criterion~     validity.~   "
51094|NCT02898077|"~     The purpose of this study is to evaluate the efficacy of the study drug known as ramucirumab~     in participants with gastric and gastroesophageal cancer.~   "
51095|NCT02898064|"~     Consenting patients with multiple myeloma (MM) will be randomly allocated to receive either~     standard medical treatment (chemotherapy, radiotherapy, pain-killing medication) alone or~     standard medical treatment plus a brace. Patients will be regularly evaluated in research~     clinics; the results data will inform the design of a full trial. Information will be~     collected to inform a list of requirements a centre needs to have in place to run an RCT of~     these interventions.~   "
51096|NCT02898051|"~     Low molecular weight heparins (LMWH) are the reference molecule for the long term treatment~     of venous thromboembolism (VTE) in cancer patients but remains, however, associated with a~     high risk of recurrent thromboembolism. The high rate of recurrence may result from~     alterations in the pharmacokinetics of LMWH. The primary purpose of the study is to compare~     the pharmacokinetics of anti-Xa activity in patients with cancer and patients without cancer~     treated with curative dose of low molecular weight heparins (LMWH) for venous thromboembolism~     (VTE). The secondary purposes are 1/ to study the correlation between anti-Xa LMWH and~     concentration of plasma heparanase and 2/ to evaluate the predictive nature of the anti-Xa~     activity on the occurrence of thromboembolic recurrence in cancer patients treated with LMWH~     for VTE.~   "
51097|NCT02898038|"~     Tolerance and Acceptability of new oral nutritional supplement - AYMES PARIS~   "
51098|NCT02898025|"~     This study aims to evaluate the effectiveness of the low level laser therapy and~     interferential current in 168 patients with knee osteoarthritis~   "
51099|NCT02898012|"~     The optimal treatment of glioblastoma multiforme (GBM) in patients aged ≥70 years with a~     Karnofsky performance status (KPS) <70 is unestablished. This clinical trial evaluated the~     efficacy and safety of upfront temozolomide (TMZ) and bevacizumab (Bev) in patients aged ≥70~     years and a KPS <70.~   "
51100|NCT02897999|"~     The purpose of this dose-escalation study is to assess the safety and pharmacodynamics of~     single and multiple doses of QBKPN SSI, administered subcutaneously to healthy adult~     volunteers~   "
51101|NCT02897986|"~     Cancer remains the first cause of death due to disease in children and adolescents despite~     important progress and 70% of the survivors present sequelae. It is therefore mandatory to~     generate new and preferably less toxic treatment strategies relying on new anticancer agents,~     and/or new combinations or schedules of administered compounds.~      Metronomic chemotherapy (MC) consists in administrating low doses of anticancer agents on a~     daily/weekly basis. MC has been showed to be a safe and effective way to administer~     chemotherapy to obtain anti-cancer effects through anti-angiogenic and pro-imune effects.~      Drug repositioning consist in using non-anticancer drug for which anti-cancer properties have~     been unveiled. Propranolol is a non selective beta-blocker initially used to treat~     hypertension but recently its anticancer properties have been discovered. The place of~     Betablockers as anticancer agents is supported by both preclinical and epidemiologic data.~     The investigators have showed that the use of betablockers could sensitize breast cancer,~     angiosarcoma and neuroblastoma to chemotherapy in vitro and in vivo at least in part via an~     anti-angiogenic mechanism. There are currently 12 clinical trials evaluating prospectively~     their potential in adults with cancer but none in children so far.~      The Objective is to determine the Maximal Tolerated Dose (MTD) of a combination of oral~     metronomic vinorelbine and daily oral propranolol. This study is a phase I trial with a~     rolling six design and a dose escalation with thrice weekly oral vinorelbine only plus~     addition of daily oral propranolol after completion of the first cycle. PK analysis of~     vinorelbine and propranolol will be performed. Once the recommended dose of the combination~     established 4 extension cohorts of 9 patients will be added Potential biomarkers (such as~     beta-adrenergic receptors on the tumours, B-tubulin isotypes in the tumour) will also be~     evaluated.~      This will provide a well tolerated, all oral combination for patients with~     refractory/relapsing tumours. This combination could also be then proposed as a maintenance~     for instance in patients with rhabdomyosarcoma or neuroblastoma.~   "
51102|NCT02897973|"~     The prevalence of low back pain among persons with unilateral lower limb amputation is~     significantly higher than the rate experienced by the general public. Chronic pain, including~     low back pain, limits functional independence and negatively impacts quality of life. As~     such, this project will investigate the role of a biomechanical casual pathway in the~     development of low back pain; to do this, the investigators will explore the relationship~     between the adopted neuromuscular patterns post-amputation to perform activities of daily~     living and the risk of developing spinal tissue damage.~   "
51114|NCT02897817|"~     The aim of this study is to evaluate, at 6 months, the rate of patients whose adherence to~     injectable MTX remained strong or improved according to patient-reported outcome.~   "
51509|NCT02892682|"~     Previous studies reported infraclinical modifications of the homeostasis in chronic~     urticaria, recurrent idiopathic angioedema and hereditary angioedema. This study aim to~     compare groups with isolated wheals, isolated angioedema, combination of both and hereditary~     angioedema in terms of coagulation pathways.~   "
51103|NCT02897960|"~     Abnormal respiratory sounds (wheezing and/or crackles) are diagnosis criteria of acute~     bronchiolitis. One third of these infants will develop recurrent episodes, leading to the~     diagnosis of infant asthma. Nowadays, no available treatment shortens the course of~     bronchiolitis or hastens the resolution of symptoms, thus, therapy is supportive. Our~     hypothesis is that the diagnosis of wheezing during bronchiolitis (~60% of infants) will help~     to select infants who will benefit from anti-asthma therapy. In this setting the diagnosis of~     wheezing is crucial, and an objective tool for recognition of wheezing is of clinical value.~     The investigators developed a wheezing recognition algorithm from recorded respiratory sounds~     with a Smartphone placed near the mouth (Bokov P, Comput Biol Med, 2016). The objectives of~     the present cross sectional, observational study are 1/ to further validate our approach in a~     larger sample of infants (1 to 24 months) admitted to hospital for a respiratory complaint~     during the period of viral bronchiolitis, and 2/ to use gold standard diagnosis of wheezing~     by respiratory sound recording (Littmann) and subsequent analysis by two experienced~     pediatricians.~   "
51104|NCT02897947|"~     There is no international consensus on evaluation and surgical treatment of Lumbar Spinal~     Stenosis (LSS). The indication for operative treatment is relative, and the variation in~     surgical rates and procedures is significant, both within and between countries.~     Understanding practice-based variety is critical since these differences may reflect a~     disparity in quality of the health care in different institutions, regions, or countries.~     Norway, Sweden, and Denmark do all have National spine registers for research and quality~     assessment. Comparing indications for surgery, selected procedure, patient reported outcomes,~     and factors predicting outcome after surgery for LSS between these countries could provide~     information about optimal indications and strategy for surgery. Register-based studies have~     advantages such as large sample sizes and high external validity, but also limitations such~     as lower follow-up rates, and inferior data quality compared to clinical trials.~      Hypotheses: Between these three countries, there are no differences in (i) indications for~     surgery, (ii) patient-reported outcome after surgery or (iii) risk factors associated to~     outcome are similar.~   "
51105|NCT02897934|"~     The objectives of this work are threefold:~        1. To evaluate the analgesic efficacy of CWI in women discharged within 23 hours of major~          breast cancer surgery~        2. To evaluate objective indices of patient recovery following anaesthesia and surgery in a~          23 hour model of care~        3. To evaluate patient satisfaction with their care pathway~   "
51106|NCT02897921|"~     Many myopathies are inherited in a recessive manner, but in some of these recessively~     inherited disorders, clinical manifestations may potentially manifest in carriers of just a~     single mutation.~      The aim of the study is to describe the clinical characteristics of single mutation carriers~     of recessive myopathy, through measuring serum creatine kinase, muscle strength, muscle~     degeneration (by MRI) and heart affection. The investigators will do this by blood sampling,~     Biodex 4 Isokinetic Dynamometer, MRI analysis, ECG, Holter monitoring, and echocardiography.~      The aim is further to describe whether these characteristics are found primarily with~     specific mutations.~   "
51107|NCT02897908|"~     The primary goal of this study is to establish a database of people with varying levels of~     hepatic fibrosis and various etiologies of liver disease for use in future research~     protocols.~   "
51108|NCT02897895|"~     The study is an interventional, multicentre, prospective, randomized, controlled,~     single-blind, comparative trial of two processes for adjusting the inhibitor of calcineurin~     (CNI) dosage in lung transplant recipients. Recipients will be stratified by transplant~     center and according to the underlying lung disease (affected with cystic fibrosis or not)~     and will be randomized to either evaluation of calcineurin activity (CN-a) in combination~     with CNI blood levels versus CNI blood levels alone in a 1:1 ratio. The objective is to~     compare the proportion of acute rejection that has required a specific curative treatment at~     6 months after transplantation between patients in the two groups.~   "
51109|NCT02897882|"~     The objective of this project is to estimate the frequency and the characters of the chronic~     pains by a follow-up which begins during the registration on the waiting list of transplant~     and which ends at the end of the third year following the lung transplantation. It is a~     forward-looking study of prevalence entering within the framework of the common care. After~     lung transplant, pain will be evaluate with questionnaires every day during the~     hospitalisation, and then after 1 month, 3 months, 6 months, 1 year, 2 years and 3 years.~   "
51110|NCT02897869|"~     Single-center, open-label, 2-sequence, 3-period crossover drug-drug interaction study.~     Repeated doses of POL7080 and repeated doses of amikacin will be administered alone or~     combined. In total, 14 subjects will be enrolled to obtain at least 10 evaluable subjects.~     The study consists of an eligibility screening period, up to 3 treatments periods and a~     follow-up visit.~   "
51111|NCT02897856|"~     The goal of this study is to prove that intramuscular midazolam is more effective than buccal~     midazolam in cessation of seizure activity with comparable side effects.~   "
51112|NCT02897843|"~     Electroconvulsive therapy (ECT) is an effective treatment for a variety of psychiatric~     disorders. However, despite continued advances in ECT technique, neurocognitive dysfunction~     continues to be a frequent adverse effect. Declarative memory and less so selective memory~     are often impaired after an ECT course. Immediate memory, however, is broadly preserved. It~     is hypothesized that memory impairments are due to ECT induced disruptions on long term~     potentiation as well as in cerebral flux and glutamatergic and cholinergic systems. Different~     pharmacological agents for the treatment of ECT induced cognitive dysfunction have been~     tried. Agents such as opioids, vasopressin, neuropeptides, cholinergic agents, thyroid~     hormone, and stimulants have been used with equivocal results, and no controlled studies~     showed clear efficacy.~      Transcranial direct current stimulation (tDCS) is a non-invasive, painless brain stimulation~     treatment that uses direct electrical currents to stimulate specific parts of the brain.~     Electrical currents are applied constantly at low intensities (1-2 mA) over a long period,~     usually in minutes (5-30 minutes), to achieve changes in cortical excitability by influencing~     spontaneous neural activity. There are two types of stimulation with tDCS: anodal and~     cathodal stimulation. Anodal stimulation acts to excite neuronal activity while cathodal~     stimulation inhibits or reduces neuronal activity. Several studies demonstrated moderate to~     strong effect sizes of tDCS in various neurocognitive and neuropsychiatric settings. Majority~     of studies show positive effects of tDCS on cognitive functioning among healthy volunteers~     and subjects with neurological or psychiatric conditions. Beneficial effects of online~     stimulation applied over the left dorsolateral prefrontal cortex have been reported for~     working memory, attention and information processing in depressed patients. To the~     investigators' knowledge no studies have evaluated the potential efficacy of tDCS for the~     prevention of ECT induced cognitive adverse effects.~      In the current study, the investigators propose a double blind, randomized controlled trial~     to test the use of tDCS as a strategy to prevent or mitigate the memory impairments~     frequently associated with an ECT course.~   "
51510|NCT02892669|"~     This study is designed to evaluate the predictive value of heart rate variability on medial~     outcome in patients admitted to the intensive care department~   "
51115|NCT02897804|"~     The overall objective of the proposed research is to reduce the incidence of sexually~     transmitted infections (STIs) among college students. The investigators propose to accomplish~     this by using the innovative, engineering-inspired multiphase optimization strategy (MOST) to~     develop a highly effective, appealing, economical, and readily scalable internet-delivered~     behavioral intervention targeting the intersection of alcohol use and sexual risk behavior.~     The rate of STIs on college campuses is alarming: one in four college students is diagnosed~     with an STI at least once during their college experience. Sexual activity when drinking~     alcohol is highly prevalent among college students. Alcohol use is known to contribute to the~     sexual risk behaviors that are most responsible for the transmission of STIs, namely~     unprotected sex, contact with numerous partners, and hook-ups (casual sexual encounters).~     Few interventions have been developed that explicitly target the intersection of alcohol use~     and sexual risk behaviors, and none have been optimized. In order to reduce the incidence of~     STI transmission among this and other high-risk groups, a new approach is needed. MOST is a~     comprehensive methodological framework that brings the power of engineering principles to~     bear on optimization of behavioral interventions. MOST enables researchers to experimentally~     test the individual components in an intervention to determine their effectiveness,~     indicating which components need to be revised and re-tested. Given the high rates of alcohol~     use and sex among college students, the college setting provides an ideal opportunity for~     intervening on alcohol use and sexual risk behaviors. The proposed study will include a~     diverse population of college students on 4 campuses which will increase the generalizability~     of the findings. The specific aims are to (1) develop and pilot test an initial set of online~     intervention components targeting the link between alcohol use and sexual risk behaviors, (2)~     use the MOST approach to build an optimized preventive intervention, and (3) evaluate the~     effectiveness of the newly optimized preventive intervention using a fully powered randomized~     controlled trial (RCT). This work will result in a new, more potent behavioral intervention~     that will reduce the incidence of STIs among college students in the US, and will lay the~     groundwork for a new generation of highly effective STI prevention interventions aimed at~     other subpopulations at risk.~   "
51116|NCT02897791|"~     Main idea perception of written stories and in pictures among impaired right hemisphere~     patients Abstract The right hemisphere is considered to complement the language processing~     abilities of the opposite hemisphere; it is responsible for the processing of secondary and~     unusual characteristics of linguistic stimulates. This processing enables, among other~     functions, the comprehension of metaphors and humor. Additionally, it enables the execution~     of inferring from spoken and written discourse. Studies which deal with common impairments~     among right-hemisphere-damaged (RHD) individuals, found that inference processing of written~     stories and narrative sequences presented in pictures was impaired. This impairment could~     damage the ability to create global coherence, which is an important component of central~     theme comprehension of different types of narrative. Another important component is~     superstructures, schemas which aid creating, remembering and producing the main ideas of~     spoken and written discourse. Other studies consider impairment in creating global coherence,~     or Theory of Mind impairment, as the source of central theme comprehension impairment among~     RHD individuals.~      Discourse is an integral part of interpersonal communication, and of proper social conduct.~     The themes chosen for conversation reflect the functional role of discourse from semantic and~     pragmatic points of view.~      The aim of the current study is to deepen the current knowledge concerning central theme~     comprehension among RHD individuals following cerebrovascular accident (CVA), in two genres~     of written discourse (classic stories and stories with a twist), and in situations~     represented by single pictures. Unlike written stories, the extraction of the central theme~     out of a single picture requires focusing on a single situation and relying on non-linguistic~     visual information. Differences concerning central theme comprehension in the different~     discourse genres and in the pictures might be able to assist in selecting diagnostic and~     therapeutic tools designed to work on high cognitive-linguistic abilities, which are usually~     impaired among RHD individuals. In later stage, these tools are meant to help improving RHD~     individuals' spontaneous narrative skills.~      The study will include 20 RHD adults following CVA, and 20 healthy adults without any known~     damage to the right hemisphere. The two groups will be matched concerning sex, age,~     educational level and socio-economic status. The subjects will perform the study tests during~     three sessions, 60 minutes each. The screening tests will include language diagnosis -~     Western Aphasia Battery (WAB), and reading test no. 37 included in the Psycholinguistic~     Assessments of Language Processing in Aphasia's battery (PALPA). Patients diagnosed with~     aphasia will be excluded from research. The research tests will include: central theme~     comprehension test in stories and pictures, including classic stories, stories with a twist,~     and pictures of different situations (each will be accompanied by a multiple-choice question~     concerning the central theme), sub- exanimations taken from Frigbi battery designed to~     evaluate memory and phonological memory capacity, Raven's Progressive Colored Matrices test~     designed to evaluate pre-morbid abilities (non-linguistic), Theory of Mind (T.O.M) evaluation~     test, and tests designed to evaluate central coherence impairment: Navon Figures test for~     evaluation of global visual perception impairment, and Rey-Osterrieth Complex Figure Test~     (RCFT) - Recall Form test for evaluation of visual-perceptive organizational ability, and~     non-verbal memory. The performances of the two groups will be compared in each test using~     statistical tests. In addition, the interaction between all variables will be measured.~   "
51117|NCT02897778|"~     The purpose of this study is to evaluate the effect of entinostat on heart rate and other~     electrocardiogram parameters. This study will also evaluate the safety and tolerability of~     entinostat, as well as pharmacokinetic and pharmacodynamic parameters.~   "
51118|NCT02897765|"~     The purpose of this study is to evaluate if the treatment with NEO-PV-01 + adjuvant in~     combination with nivolumab is safe and useful for patients with certain types of cancer. The~     study also will investigate if NEO-PV-01 + adjuvant with nivolumab may represent a~     substantial improvement over other available therapies such as nivolumab alone. All eligible~     patients will receive NEO-PV-01 + adjuvant and nivolumab while on this trial.~   "
51119|NCT02897752|"~     RATIONALE:~      The previous study resulted that the gait training using Functional Electrical Stimulation~     (FES) improved the ankle joint function and the walking ability for the chronic stroke~     patients with foot drop.~      In addition, the further exploratory study in multicenter obtained the result that the~     training with WA were especially good adaptation to the patients who have slight paralysis~     and can walk independently.~      PURPOSE:~      This multicenter prospective trial is studying to reveal whether the gait training with the~     WalkAide[R](WA) for chronic stroke patients who can walk independently is superior to gait~     training with a physical therapist.~   "
51120|NCT02897739|"~     Tako Tsubo Cardiomyopathy (TTC), also known as Broken Heart Syndrome, is a disorder of the~     heart that occurs most commonly in women (although it occasionally occurs in men) and is~     usually related to a stressful event. Symptoms are often similar to a heart attack, and~     include chest pain and shortness of breath. Although Tako Tsubo Cardiomyopathy is not a new~     medical condition, it has not been widely recognised until the last decade. Currently the~     investigators don't have an exact understanding of how or why the heart is affected in this~     way, and so the investigators are conducting a study to help understand what causes Tako~     Tsubo Cardiomyopathy.~   "
51121|NCT02897726|"~     The purpose of this study is to evaluate and compare the safety and pharmacokinetics of~     NVP-1402 and NVP-1402R in healthy male subjects.~   "
51122|NCT02897713|"~     Patients with mechanical ventilation are in risk of malnutrition, which could lead to worse~     outcome. According to guidelines released from authority organizations, enteral nutrition~     (EN) should be prior approach for critically ill patients. However, initiation and delivery~     of EN during the early period of ICU admission are frequently hampered, which results in~     underfeeding. The investigators speculate whether an intensive enteral nutrition strategy~     could reinforce the delivery of EN thereby improving outcomes. In this multi-center,~     prospective, randomized parallel clinical trial, the investigators aim to assess the~     feasibility, safety and outcomes of intensive enteral nutrition in mechanical-ventilated~     patients.~   "
51123|NCT02897700|"~     The overarching purpose of this study is to determine if the mainstay chemotherapeutic~     regimens represented by several genotoxic agents including but not limited to~     Cyclophosphamide, Doxorubicin, Epirubicin, Fluorouracil and Methotrexate (CDEFM), in the~     format of either a single agent or combinations are safe, tolerable, and effective in the~     treatment of patients with infiltrating ductal carcinoma of breast.~   "
51124|NCT02897687|"~     Twelve participants were randomized to either a Facebook group or a book club group for six~     weeks. Data was collected on the participants social and behavioral function at both the~     start and the conclusion of the intervention.~   "
51125|NCT02897674|"~     Aims: To investigate whether diet with realistic doses on palm oil will have an effect on~     lipid profile and fat deposition in healthy volunteers.~      Design: Randomized, parallel design over 14 weeks including a 2 week standardization period~     and 12 week supplementation. In the standardization period all participants will incorporate~     palm oil into their diet which will make up 20% of their calories providing a baseline~     measure. In the supplementation period of 12 weeks, each volunteer will be randomized into~     one of the three fats: palm olein, interesterified palm olein or soybean oil, consuming 20%~     of their calories from these fast and remaining 10% fat calories from fats naturally~     occurring in foods like meat and nuts. Otherwise participants will keep the rest of their~     diet habitual.~      Population: 60 healthy males and females aged between 18 and 60 years, of which 30~     participants with a BMI between 18.5-24.9kg/m2 and 30 participants with a BMI between~     25-29.9kg/m2 and fasting plasma glucose and no evidence of insulin resistance will be~     recruited. No pre-existing morbidity including cardiac, hepatic or renal disease, history of~     diabetes, hypertension or hyperlipidemia.~      Treatment: Pre-intervention: Participants will be asked to record habitual dietary intake by~     completion of a 4-day food diary and be asked to wear an accelerometer armband to assess~     physical activity at the beginning and at the end of supplementation period.~      2 weeks standardization period: All participants will be asked to replace added fat in their~     diet with palm olein providing two thirds of 30% fat calories.~      At the end of the standardization period, which will be the first day of a 12 week dietary~     intervention, as well as at the end of 12 week supplementation, participants will attend the~     clinical research facility for a study visit. Weight, height and waist circumference will be~     taken; total and regional body composition will be measured by MRI. Fasting and post prandial~     plasma glucose, insulin, appetite hormones and lipids will be measured. Participants will be~     asked to come in for follow-up visits at week 6 and 10 for a single blood samples and weight~     check.~      12 week supplementation period: participants will be randomized into one of the three~     supplementation groups: palm olein, interesterified palm olein or soybean oil. Participants~     will be asked to consume two thirds of their 30%fat calories from one of the oils while~     incorporating it into their normal diet in cooking and baking.~   "
51126|NCT02897661|"~     Patients with Crohns' disease are always complicated with malnutrition. This trial aimed to~     assess whether FMT accompanied by enteral nutrition (EN) can make contributions to patients~     with Crohns' disease.~   "
51511|NCT02892656|"~     The purpose of this study is to determine the reliability of the Oswestry disability index~     (ODI) Numerical Rating Scale (NRS), Pain Self-Efficacy Questionnaire (PSEQ) and the Major~     Depression Inventory (MDI) in a chronic low back pain (CLBP) population referred to The~     Danish Rheumatism Associations´ rehabilitation centre Sano Aarhus.~   "
51127|NCT02897648|"~     The route of subcutaneous administration of drugs has become a common practice in some~     specialties (palliative care, geriatrics).~      This is an alternative to oral, sublingual, rectal or intravenous Many drugs are used by~     subcutaneous route but few clinical studies evaluating the level of scientific relevance~     justifies their use.~      The purpose of this study is to assess:~        1. / Determine that there is no difference between the subcutaneously compared to~          intravenous administration in terms of dosage and serum PK / PD of Beta lactam~          objectives in a geriatric population.~        2. / The safety and lack of toxicity of administrations subcutaneously.~      Advantages disadvantages~        -  easy Of establishment~        -  Simplicity Monitoring and manipulation~        -  Reduced Risk of infection~        -  No Risk of venous thrombosis~        -  Lower cost Simple -Technique for support at home taking~        -  Limitation Aggressive gestures~        -  multiplicity Of all possible injection sites~        -  Technique Of choice for agitated patients or confused -Risk of localized edema (<1000mL~          / 24 / site)~        -  Use Impossible for some drugs~        -  Risk Discomfort and intolerance at the injection site~      A practical study was conducted among 382 physicians (289 geriatricians and 93 infectious~     disease specialists). Among them 97.5% reported regular use of the subcutaneous route for the~     administration of antibiotics.~      Declarative criteria pretend curb the use of this route was the lack of data Pk / Pd (61.2%);~     the absence of marketing authorization for the subcutaneous route (34.5%); the absence of~     serum assay available (2.1%).~   "
51128|NCT02897635|"~     The purpose of this study is to develop and test a 12-month Integrative Medicine intervention~     based on Ayurvedic medicine in recent breast cancer survivors.~   "
51129|NCT02897622|"~     Patients with severe and enduring eating disorders (SEED) are seriously ill and have a low~     quality of life. In 2014, a special unit based on case management (CM), for patients with~     SEED (the Eira unit) was started at Stockholm Centre for Eating Disorders, Sweden. Eating~     disorder is a serious illness that creates a great deal of suffering. Most patients who~     undergo specialized eating disorder treatment will be healthy, but a small percentage of the~     patients develop a SEED. SEED patient have gone through numerous of treatments and has been~     to several specialists units for years as well as they has completed many different therapies~     without getting fee from the eating disorder (ED). Due to the long term sick in ED the SEED~     patient is often alone and has difficulties to cope with everyday life situations. SEED~     patients are a vulnerable patient population with a great suffering and poverty to release~     the identity of the ED. However, no previous study is done in which patients with SEED~     themselves describe their own theory about why they are still ill and how specialized eating~     disorder care has affected them. In the ED field, there is a growing consensus that treatment~     of patients with SEED needs to be multi-professional, with a focus on improving the patients'~     social situation, minimizing medical complications, and enhancing quality of life and~     independence, rather than focusing one-sided on symptom reduction. Is case management a way~     to help the SEED patients witness a better quality of life? Besides the personal suffering of~     patients and their families, SEED is also associated with high costs for health care and for~     society in general.~   "
51130|NCT02897609|"~     3rd generation cephalosporins (C3G) are the antibiotics recommended in probabilistic in most~     enteric infections in France including pyelonephritis and bacteraemia.~      However, the prevalence of resistance of Enterobacteriaceae including E. coli to C3G is~     continuously increasing for several years. In 2012, in France, the proportion of E. resistant~     or intermediate coli categorized to C3G is 10 to 25% (EARSS data).~      Antibiotics not adapted early in severe sepsis is responsible for worse prognosis for~     patients in terms of morbidity and mortality and unnecessary prolongation of the DMS.~      At St. Joseph's Hospital on enterobacteria levels of resistance to C3G is 15.4%.~      To avoid overuse of carbapenems for probabilistic antibiotic and to quickly prescribe~     antibiotics adapted to the resistance of the bacteria, it is interesting to use a rapid test~     for detection of resistance to C3G.~      The Lacta ™ test could be used in this indication. This is a rapid test diagnostic~     orientation detecting hydrolysis of a substrate (chromogenic cephalosporin) by the enzymatic~     action of ESBL, cAMP-type cephalosporinases and carbapenemases. This test was initially~     marketed for rapid detection of resistance to C3G enterobacteria from isolated bacterial~     colonies in culture.~   "
51131|NCT02897596|"~     Evaluate the efficacy of 12 or 8 weeks treatment with Grazoprevir/Elbasvir in Early Chronic~     Hepatitis C GT1,4 in HIV co-infected patients and evaluate the safety and tolerability of~     Grazoprevir + Elbasvir in HIV-HCV co-infected patients.~   "
51132|NCT02897583|"~     This is a single-center, prospective randomized controlled trial evaluating the safety and~     efficacy of YAG vitreolysis versus sham for symptomatic Weiss ring due to posterior vitreous~     detachment.~   "
51133|NCT02897570|"~     This study aims at assessing the effects of glucose and different types of breakfast on~     metabolic and neurofunctional responses in healthy individuals.~      Twelve healthy subjects, on a stable diet, in a randomized-crossover fashion, received either~     a 50 g glucose load (control) or one of these breakfast:~      B1: milk (125ml) and cereals (30g); B2: milk (220ml), apple (200g) and cream chocolate filled~     sponge cake (30g); B3: milk (125ml), bread (50g), apple (150g) and hazelnut cream chocolate~     (15g). Prior and upon completion of each tolerance test, an EEG was performed to measure~     frontal P300-evoked potentials.~   "
51134|NCT02897557|"~     The purpose is to perform an early investigation on the safety and performance of an~     Automated Glucose Control (AGC) algorithm using the OmniPod® Insulin Management System and~     gather clinical data that will be used to make improvements or modifications to the algorithm~     for subsequent studies in adults, adolescents and children with type 1 diabetes.~   "
51135|NCT02897544|"~     The purpose of this study is to develop and test a 6 month manualized Health Education~     intervention in recent breast cancer survivors.~   "
51136|NCT02897531|"~     The purpose of this study is to evaluate the efficacy of end-to-side anastomosis after~     laparoscopic right hemicolectomy compared with that of side-to-side anastomosis. The~     investigators hypothesize that the end-to-side anastomosis may be associated with superior~     recovery compared with side-to-side anastomosis after laparoscopic right hemicolectomy under~     enhanced recovery program. The primary endpoint is the cumulative recovery rate, consisting~     of the recovery time of diet, pain, ambulation, and afebrile status.~   "
51996|NCT02886325|"~     The overall goal is to develop a culturally appropriate and easy to disseminate educational~     intervention documented to improve cancer prevention and increase cancer screening behaviors~     in the rural Midwest.~   "
51137|NCT02897518|"~     The primary end point of this study is the feasibility of intubation. The secondary~     end-points are the success to intubate in the first attempt, the intubation time, the Cormack~     and Lehane score view, the comparison of the intubation difficulty scale (IDS) score and the~     need for maneuvers to aid the endotracheal intubation comparing Imago V-Blade ® and~     Glidescope®.~      Patients admit to the operation rooms of University of Naples Federico II and requiring~     endotracheal intubation for general anesthesia will be consecutively screened for the~     presence of predicted difficult airway according Italian guideline. According to this~     guideline, the presence of one or more of the following parameters may be considered highly~     predictive of difficult intubation: Mallampati class 3-4, inter-incisor distance < 30 mm,~     mental-thyroidal distance < 60 mm, large prominence of superior incisors above inferior~     incisors uncorrectable with jaw-thrust, reduced head and neck motility, and reduced~     mental-jugular distance. Patients matching more then 1 of the previous criteria stated by~     Italian guideline will be included in this case controlled study. Patients 1) without~     criteria for predicted difficult airway; 2) those requiring emergency surgery; 3) aged < 18~     years; or 4) declined consent to participate, will be excluded from this study.The primary~     end-point was the comparison of the intubation difficulty scale (IDS) score. The secondary~     end-points were the learning curve, the intubation time, the Cormack and Lehane score view,~     and the need for maneuvers to aid the endotracheal intubation comparing different~     videolaryngoscopes available in our department. Two anesthesiologists with 10 years of~     experience in conventional endotracheal intubation and trained for video assisted intubation~     will perform the maneuvers.~   "
51138|NCT02897505|"~     Women will be recruited from the EMPOWER clinic when they present for care; they may be given~     a flyer as part of their clinic entry paperwork, or approached by a study staff member in the~     waiting area of the clinic. Women who are clients of Sanctuary for Families may find out~     about the music workshops and the study through Sanctuary for Families staff, who will post~     flyers in their noticeboards or offices.~      This study will use a repeated measures survey design to evaluate the effect of a musical~     workshop intervention to aid in the management of mood, anxiety, and stress among women~     enrolled in the EMPOWER clinic for survivors of sex trafficking and sexual violence.~     Assessment of the feasibility and acceptability of this music intervention will be carried~     out on participants as they are taught to manage stress and emotions.~   "
51139|NCT02897492|"~     Patients with chest pain may have postponed or missed diagnosis of acute coronary events due~     to relatively late detection of troponin elevation. The study will investigate a new~     diagnostic method for early detection of even minimal troponin elevation in patients admitted~     with chest pain.~   "
51140|NCT02897479|"~     This is a Phase II, open-label, multicenter study of Savolitinib administered orally once per~     day(QD) to locally advanced/metastatic PSC patients with MET Exon 14 mutation. The targeted~     population is the patients with MET Exon 14 mutation who have failed prior systemic therapy~     (ies), or are unwilling or unable to receive chemotherapy. Pathological diagnosis will be~     confirmed retrospectively by the central pathological laboratory.~   "
51141|NCT02897466|"~     Inappropriate antibiotic therapy in ventilator-associated pneumonia (VAP) is associated with~     increased mortality. The international guidelines recommend using broad spectrum~     antimicrobials especially in patients who received previous antimicrobials, with risk factors~     of muti-drug resistant (MDR) VAP or after 5 days of mechanical ventilation. Using~     broad-spectrum antibiotics for 48h until the results of conventional cultures and~     antimicrobial susceptibility testing (AST) are available, may promote the emergence of~     drug-resistant bacteria. Exposure to imipenem, as short as 1 to 3 days, is associated with a~     5-fold increase in the risk of imipenem resistance in the gut microbiota of ICU patients~     (Armand-Lefevre AAC 2013). Performing AST directly on clinical respiratory samples would~     hasten the process by at least 24h.~      The diagnostic performance of a rapid method combining mass spectrometry and direct AST~     [DAST] are previously analyzed, and compared it with the conventional method (mass~     spectrometry with conventional AST [CAST]) and its potential impact was assessed on~     antimicrobial use in 85 patients (Le DORZE M et al - Clin. Microbiol. Infect. 2015).~      The results produced by the dast were useable in 85,9% of the cases and the sensitivity and~     negative predictive values of DAST were 100% for all antibiotics tested, except gentamicin~     (97.1% [95%CI = 93.3-101] and 97.4% [93.7-101], respectively) and amikacin (88.9% [81.7-96.1]~     and 96.4% [92.1-100.7], respectively), compared with CAST. Specificity and positive~     predictive values ranged from 82.9 (74.2-91.5) to 100%, and from 86.4 (78.5−94.2) to 100%,~     respectively. If results had been reported to the clinicians, that DAST would have saved~     carbapenem prescription in 17 cases (22%) and would have allowed immediate narrow spectrum~     antimicrobials in 35/85 (41.2%) cases. But, the benefit of DAST was based on a simulation and~     should be now tested in a randomized fashion. This project is a prospective multicenter~     study. The hypothesis is that, DAST compared to CAST, would increase the number of adequate~     antimicrobial therapy within 24 hours in case of late VAP (> 5 days under mechanical~     ventilation) with Gram negative bacilli (GNB) in IC patients while sparing carbapenems~     (imipenem and meropenem). The primary objective is to determine the impact of a strategy~     using DAST on the rate of day1 adequate therapy without carbapenems in case of late VAP due~     to GNB.~   "
51142|NCT02897453|"~     This study is an opportunity to gather long term safety and efficacy information from~     patients who have had their scoliosis treated via anterior vertebral body tethering (VBT).~   "
51143|NCT02897440|"~     A prospective cohort study to compare full repairing and partial repairing of soft tissue~     surrounding the hip joint in anteriorolateral approaching arthroplasty concerning hip~     function. Patients admitted with a femoral neck fracture operated with a hip arthroplasty~     through an anteriorolateral approach were screened for inclusion. Patients with altered~     mental status SPMSQ <7, pathological fractures, non-walkers were excluded.~   "
51144|NCT02897427|"~     The goal of this clinical research study is to learn about the relationship between human~     papillomavirus (HPV) and cancer risk in men who test positive for HPV antibodies. Antibodies~     are created by the immune system and may attack foreign cells or diseased cells, such as HPV.~      HPV infections can lead to oropharyngeal (throat area), anal, and/or penile cancer. The goal~     of the entire study is to learn if screening for HPV can help doctors learn which patients~     may be at a higher risk for developing these types of cancer.~      This is an investigational study.~      Up to 5000 men may be enrolled in this study. All will take part at MD Anderson.~   "
51145|NCT02897414|"~     In April 2011, the U.S. Food and Drug Administration (FDA) determined that a class-wide risk~     evaluation and mitigation strategy (REMS) for all extended-release (ER) and long-acting (LA)~     opioid medications was necessary to support national efforts to reduce serious adverse~     outcomes resulting from opioid abuse. This study will evaluate trends before and after the~     ER/LA REMS implementation for changes in mortality rates associated with prescription opioids~     utilizing state medical examiner databases from multiple states. Databases from 2005 through~     the most recent year available will be obtained.~   "
54442|NCT02854345|"~     The goal of this study is to assess the performance of parathyroid imaging on a~     cardiac-dedicated CZT camera, compared to planar pinhole imaging, in patients referred for~     primary hyperparathyroidism.~   "
51146|NCT02897401|"~     Multicenter, national study, non-randomized , controlled, comparative with 4 independent~     groups (20 participants in each group). There are 3 experimental groups (smocker, nicotine~     replacement therapy an electronic cigarette) and 1 control group (without nicotine).~      The main objective of the study is to compare the level of urinary NNN in the electronic~     cigarette users versus the nicotine replacement therapy (patch) users.~   "
51147|NCT02897388|"~     To assess the prevalence of breast milk feeding in a NICU in China, to implement a quality~     improvement program to increase breast milk feeding, and to evaluate its impact.~   "
51148|NCT02897375|"~     This phase I trial studies the side effects and best dose of palbociclib with cisplatin or~     carboplatin in treating patients with solid tumors that have spread to other places and~     usually cannot be cured or controlled with treatment. Palbociclib may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as cisplatin and carboplatin, work in different ways to stop the growth of~     tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them~     from spreading. Giving palbociclib with cisplatin or carboplatin may help stop tumor growth~     in patients with advanced solid tumors.~   "
51149|NCT02897362|"~     This study seeks to characterize sleep physiology in adolescents with and without Attention~     deficit hyperactivity disorder (ADHD) and its relationship to differential neurocognitive and~     clinical outcomes within these groups.~   "
51150|NCT02897349|"~     To evaluate the efficacy and safety of linagliptin compared to placebo when added on to~     insulin therapy alone or in combination with metformin in Chinese patients with type 2~     diabetes mellitus with insufficient glycaemic control~   "
51151|NCT02897336|"~     An open-label randomized trial to compare the efficacy of ultrasound-guided caudal and~     interlaminar corticosteroid injections for the treatment of lumbar disk herniation-related~     sciatica.~   "
51152|NCT02897323|"~     The incidence of congenital heart disease is about 8 per thousand live births. Thanks to~     advances in cardiac surgery, 90% of children born with heart defects reach adolescence and~     adulthood. Congenital heart defects are the leading cause of heart disease in young adults~     and expectant mothers in Western countries. The number of patients increases continuously as~     life expectancy increases. An increasing number of patients with complex heart defects~     survive to adulthood. The medico-surgical management of this highly specialized growing~     number of patients is difficult and requires a multidisciplinary collaboration. In France, an~     estimated 200,000 patients the number of carrier patients with congenital heart disease. Half~     of them will require monitoring, medical procedures, catheterizations and/or surgical~     re-intervention. No objective demographic data are currently available on the French~     patients. So, the investigators decided to set up an epidemiological project to better~     understand this cohort of patients. The main objective of this project is to obtain accurate~     epidemiological data needed to adapt the supply of care.~   "
51153|NCT02897310|"~     This study assess the vital status, renal function and renal recovery of patients admitted to~     intensive care unit and requiring renal replacement therapy for acute kidney failure. Patient~     follow up is up to 3 years after ICU admission when possible.~   "
51154|NCT02897297|"~     All patients diagnosed or followed in Brest University Hospital for Philadelphia negative~     MPNs will be included in this observational study.~      MPNs recorded included: polycythemia vera (PV), essential Thrombocythemia (ET) and Primary~     Myelofibrosis (PMF).~      This is a not interventional study. Alive patients need to sign a non-opposition consent~     form.~      Patients will be followed until last news (death, change of reference centre...).~   "
51155|NCT02897284|"~     Burnout Syndrome is one of the major challenges for health systems worldwide. This study~     strives to evaluate the feasibility and effectiveness of an 8- versus 2-week~     mindfulness-based self-care program on burnout symptoms and psychological and biological~     variables.~   "
51156|NCT02897271|"~     The purpose of this study is to investigate features of patients with Eosinophilic~     Gastrointestinal Disorders (EGIDs) other than Eosinophilic Esophagitis (EoE) alone, including~     Eosinophilic Gastritis (EG), Eosinophilic Gastroenteritis (EGE), and Eosinophilic Colitis~     (EC).~   "
51157|NCT02897258|"~     The study T2HD Thrombosis and Haemorrhage in chronic hemodialysis patients is a study of~     pharmacoepidemiology observational, retrospective cohort, multicenter including 12 dialysis~     centers for adults Lorraine.~      The main objective is to :~      Describe the prescribing practices of drugs anticoagulants and antiplatelet agents in chronic~     hemodialysis patients in the Lorraine region.~      The second objective is to :~      Study the impact of these practices on the survival and the occurrence of major clinical~     events, thrombotic and hemorrhagic.~   "
51158|NCT02897245|"~     Treatment of Chronic Myeloid Leukemia (CML) has been revolutionized by the use of tyrosine~     kinase inhibitors including imatinib mesylate (Gleevec, Novartis Laboratories). Two other~     inhibitors of the BCR-ABL kinase are currently on the market in France, nilotinib (Tasigna®,~     Novartis Laboratories) in the first and second-line treatment and dasatinib (SPRYCEL®,~     Bristol-Myers Squibb Laboratories) in second line. Achieving a complete molecular response~     (CMR) in patients with Chronic Myeloid Leukemia (CML) treated with tyrosine kinase inhibitors~     may be currently regarded as the ultimate level of reduction of residual disease. The pilot~     Stop Imatinib study has opened the way for a french prospective study of stopping imatinib,~     the STIM study. The results of the STIM study showed that almost 60% of patients exhibited~     molecular relapse, most frequently within the first 6 months after discontinuation. The~     parameters that are statistically associated with the loss of complete molecular response are~     the Sokal score at diagnosis and the total duration of treatment with imatinib. Criteria to~     define molecular relapse in treatment free remission patients are not well defined and~     validated. The aim of the study is to validate the loss of major molecular response as a~     robust criteria for TKI resumption. The patient's population will be CML patients who are~     offered to discontinue therapy outside the STIM strial.~   "
51172|NCT02897063|"~     The purpose of this study is to learn more about the effects of midodrine and droxidopa, two~     medications used for the treatment of orthostatic hypotension (low blood pressure on~     standing), on the veins of the abdomen of patients with autonomic failure. The study will be~     conducted at Vanderbilt University Medical Center, and consists of 2 parts: a screening and 2~     testing days. The total length of the study will be about 5 days. About 34 participants will~     be screened for the study.~   "
51159|NCT02897232|"~     This is a minimal risk, anonymous, convenience sample, social behavioral study using~     qualitative descriptive survey methods. It is to ascertain community member, physician,~     resident and medical student perspectives regarding Human Papillomavirus (HPV) infection,~     associated diseases and to identify barriers which prevent these groups from ensuring that~     males 9-26 receive the three-shot vaccine series to prevent HPV infection.~      The research is focused on these questions:~      Do community members understand the ease of transmission of the HPV virus in males 9-26? Do~     community members, physicians, residents and medical students have knowledge of the~     associated diseases that may occur with the HPV virus infection in males age 9-26? Do~     community members, physicians, residents and medical students know the ages in which males~     should receive the HPV vaccine three-shot series? What barriers prevent community members and~     physicians, residents and medical students from ensuring that males 9-26 receive the~     three-shot vaccine series to prevent HPV infection?~   "
51160|NCT02897219|"~     The objective of this study is to confirm efficacy of ASP1941 based on the changes in HbA1c~     and to assess its safety in subjects with type 1 diabetes mellitus receiving ASP1941 once~     daily in combination with insulin for 24 weeks. This study will also assess the~     safety/efficacy of long-term treatment (52 weeks).~   "
51161|NCT02897206|"~     This is a prospective, single-center, randomized, placebo-controlled, double-blind clinical~     trial that aims to investigate the beneficial and harmful effects of prophylactic use of~     imipenem in patients with predicted severe acute pancreatitis. All patients with first attack~     of acute pancreatitis, an onset of disease less than 72h before admission, and an APACHE II~     score ≥ 8 calculated within the first 24h from admission will be enrolled.~   "
51162|NCT02897193|"~     Horizontal bone augmentation procedures are commonly used to increase bone width to allow the~     placement of dental implants or to improve aesthetics in deficient areas. Smaller diameter~     implants could be used instead in order to avoid bone augmentation procedures.~      The comparison between these two solutions will be evaluated in the trial.~   "
51163|NCT02897180|"~     The use of a supplement food like Nyaditum resae is a reliable opportunity to stop the~     progression towards active TB through the most updated knowledge of this disease:the~     induction of tolerance.~      In order to demonstrate the percentage of efficacy of this approach, different studies must~     be run to elucidate the percentage of protection in different setting all over the world. The~     strategy is to establish its efficacy through a simple clinical trial, aimed just to know the~     incidence of TB in Placebo and NR treated contacts of active TB cases.~   "
51164|NCT02897167|"~     The study of immune pathways involved in the etiopathogeny of schizophrenia would be an~     important advance to understand the mechanisms involved in the development of this disease~     and it would be a turning point in drug therapy. Until now, the mechanism of action of~     antipsychotics focused on the blockade or modulation of brain dopaminergic pathways. If~     immunological pathways responsible for neuroinflammation and neurodegeneration which involve~     alterations in different areas and brain pathways (including dopaminergic pathways) are~     discovered, investigators could develop new treatments that act on these new targets,~     allowing to delay the onset of the first psychotic episode and improve the evolution and~     impact of this disease.~   "
51165|NCT02897154|"~     The objective of this study is to compare the performance of two i-STAT Analyzers in a~     Point-of-Care (POC) setting. The evaluation will be performed using a cartridge to test~     glucose, hematocrit and sodium on capillary specimens.~   "
51166|NCT02897141|"~     The goal of this study is to facilitate the dissemination and implementation of patient~     centered outcomes research using mHealth technology to improve self-management of adverse~     symptoms in persons living with HIV/AIDS (PLWH). Symptom management in PLWH is especially~     important because the US HIV epidemic continues to exact a huge toll, especially among Agency~     for Healthcare Research and Quality (AHRQ) priority populations including racial, ethnic, and~     sexual minorities and low-income persons. The incorporation of HIV symptom management~     strategies into patients' lives through the use of mHealth technologies has the potential to~     advance the effective dissemination and implementation of patient centered outcomes research~     findings.~   "
51167|NCT02897128|"~     Wound complications after sarcoma resection are frequent and potentially devastating problem.~     The burden of surgical wound complications in the lower extremity after preoperative external~     beam radiation therapy (EBRT) for soft tissue sarcoma is estimated at 43%. A noninvasive~     method of predicting complications would be extremely beneficial. The aim of this study is to~     evaluate the relationship between preoperative skin oxygenation and wound outcomes in a~     multi-center prospective analysis. This information could lead to a change in practice~     regarding surgical timing and adjunctive interventions to improve wound healing outcomes.~   "
51168|NCT02897115|"~     A study comparing a treat-to-target (T2T) intense treatment approach in participants with~     axial spondyloarthritis (axSpA) with routine treatment (Standard of Care (SOC)) concerning a~     reduction in disease activity.~   "
51169|NCT02897102|"~     The aim of this study was to investigate the effects of a structured program, which was based~     on abacus training associated with other activities, administered as weekly group classes~     over a 7 month period in older adults.~   "
51170|NCT02897089|"~     The purpose of this study is to evaluate and compare the clinical retention of a resin-based~     fissure sealant placed with prior application of etch-and-rinse and self-etch modes of~     universal adhesives.~   "
51171|NCT02897076|"~     Extensive animal studies have indicated that antenatal betamethasone exposure results in~     altered developmental trajectories of several fetal systems. Follow up of a randomized~     controlled trial has shown that antenatal betamethasone exposure might result in insulin~     resistance 30 years later. Furthermore, animal studies and randomized trials in Humans have~     clearly demonstrated that betamethasone-induced growth alterations were dose-related.~      In ewes, a 50% reduced dose regimen resulted in maximal improvement in preterm lamb lung~     function, similar to those obtained after a full dose.~      Our hypothesis is that antenatal betamethasone after a 50% dose reduction, justified by the~     potential long term effects of this drug, is not inferior to a full dose to promote fetal~     lung maturation in Humans.~   "
51209|NCT02896582|"~     This study is a multicentric, single arm phase II trial to evaluate the efficacy of upfront~     obinutuzumab in mantle cell lymphoma patients treated by Cisplatinum-Cytarabine-Dexamethasone~     (DHAP) followed by autologous transplantation plus obinutuzumab maintenance then Molecular~     Residual Disease (MRD) driven maintenance~   "
51173|NCT02897050|"~     This multi-center, open-label, phase II randomized controlled trial is to evaluate the~     efficacy of docetaxel(T) combined with metronomic cyclophosphamide/capecitabine (mCX)~     followed by fluorouracil /epirubicin/cyclophosphamide (FEC) versus T followed by FEC as~     neoadjuvant chemotherapy in treating women with triple negative breast cancer (TNBC), and to~     study the anti-tumor immune effect of metronomic neoadjuvant chemotherapy. 186 stage M0 TNBC~     patients who had a primary tumor > 2cm by imaging or an axillary lymph node > 2cm by imaging~     are randomly enrolled to receive neoadjuvant T combined with mCX (3 cycles) followed by FEC~     (3 cycles) or T (3cycles) followed by FEC (3 cycles) before surgery. The primary end point is~     pathological complete response (pCR) rate, and the secondary end points include: clinical~     response rate, toxicities, breast-conserving rate, Ki67 and CD31 reduction rate, changes in~     the percentages of peripheral blood or tumor microenvironmental regulatory T cells (Treg), T~     helper cells (Th), CD8+ T cell, and tumor-specific CTL, and changes in tumor~     microenvironmental immune cytokines. Once there is a significant statistical difference in~     terms of pCR rate between two groups, 3-year disease-free survival (DFS) and 3-year overall~     survival (OS) will be included in the secondary end points. The aims of this study are to~     determine whether the neoadjuvant T combined with metronomic CX followed by FEC can~     significantly increase the pCR rate in TNBC with acceptable toxicity, and to explore the~     anti-tumor immune effect of metronomic neoadjuvant chemotherapy.~   "
51174|NCT02897037|"~     The purpose of the study is to evaluate the efficacy and safety of bivalirudin in AMI~     patients with DES.~      This is a prospective, randomized, single-blind, active drug controlled multicenter clinical~     research and the study would enrolled a total of 380 AMI patients undergoing percutaneous~     coronary intervention (PCI) to one of two antithrombotic regimens: bivalirudin alone, or~     unfractionated heparin alone. All enrolled patients would be followed-up to 30 days.~   "
51175|NCT02897024|"~     The ACHIEVE study is a comparison of the effectiveness of 2 intensities of physical therapy~     treatment for children with Cerebral Palsy in an outpatient physical therapy setting. High~     intensity periodic is 2 hours of focused and high intense treatment per weekday for 4 weeks.~     In comparison, usual weekly is considered standard of care; although both dosing models are~     used clinically for children with CP.~   "
51176|NCT02897011|"~     To investigate whether a transient discontinuation of methotrexate MTX for 2 weeks improves~     the vaccination response to a seasonal influenza.~   "
51177|NCT02896998|"~     The objective of this trial is to demonstrate that the functional outcome of 'removal on~     demand' of the syndesmotic screw is non-inferior compared to routine removal of the~     syndesmotic screw in patients with an ankle fracture.~   "
51178|NCT02896985|"~     This is a multi-center study that explores the relationship between recapture of response~     with escalation to weekly adalimumab and trough adalimumab concentration before escalation in~     patients experiencing lack of response (LOR).~   "
51179|NCT02896972|"~     To evaluate efficacy of vitrectomy with inverted internal limiting membrane (ILM) flap~     technique for macular hole retinal detachment (MHRD) in highly myopic eyes, and to~     demonstrate postoperative clinical course of MHRD after inverted ILM flap technique using~     swept-source optical coherence tomography (OCT)~   "
51180|NCT02896959|"~     Postoperative surgical pain has been extensively study with regard to anaesthesia pain~     modalities, however little is published with regards to various arthroscopic shoulder~     surgical techniques. An intriguing characteristic of shoulder arthroscopy is the various~     arthroscopic pump pressures used by different surgeons. One could hypothesize that excessive~     water retention from the arthroscopic pump could causes excessive tissue pressure and~     swelling resulting in post operative pain. Unfortunately we could not find any literature in~     the English language regarding varying pressure pump settings on post operative pain control.~     For that reason we would like to assess how variable pump pressure effect tissue pressure~     over pre set time points, and how this may relate to post operative pain control.~   "
51181|NCT02896946|"~     The detection of small liver metastases represents a major challenge during the staging~     process of patients with pancreatic adenocarcinoma. Currently, thoraco-abdominopelvic CT~     represents the established imaging modality for selecting patients with pancreatic~     adenocarcinoma for curative surgery. However, despite its performance, 13% to 23% of patients~     undergoing a surgical procedure are finally found to have an unresectable disease because of~     arterial involvement, peritoneal carcinomatosis, or the existence liver metastasis that had~     not been detected by preoperative workup. Compared to CT, diffusion-weighted MRI provides a~     better contrast resolution for soft tissue and liver imaging, and thus leads to a better~     detection of focal liver lesions. Hence, it could be hypothesized that the use of DW-MRI in~     patients with potentially resectable PA may improve the selection process of candidates for~     curative pancreatic resection by increasing the detection of LM undiagnosed by traditional~     preoperative work-up~   "
51182|NCT02896933|"~     35 patients with multiple sclerosis have been enrolled in a previous study to record and~     analyze gait parameters.~      This study aims to enroll gender and and matched healthy subjects for a control group, to~     compare patients' gait parameters with healthy subjects'.~   "
51183|NCT02896920|"~     This study assesses Humira's® real-life effectiveness in the management of dermatological~     manifestations of moderate to severe Hidradenitis Suppurativa (HS).~   "
51184|NCT02896907|"~     This pilot clinical trial studies the side effects of ascorbic acid and combination~     chemotherapy in treating patients with pancreatic cancer that has spread to other places in~     the body, has come back, or cannot be removed by surgery. Nutrients found in food and dietary~     supplements, such as ascorbic acid, may improve the tolerability of chemotherapy regimens.~     Drugs used in chemotherapy, such as fluorouracil, irinotecan hydrochloride, and oxaliplatin,~     work in different ways to stop the growth of tumor cells, either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading. Giving ascorbic acid and~     combination chemotherapy may work better in treating patients with pancreatic cancer.~   "
51185|NCT02896894|"~     This is a mixed methods study that evaluates the effectiveness of the Big White Wall (BWW)~     online community and its implementation in 3 hospital/health system sites across Ontario. The~     6 month study includes 1000 participants that are randomized to an immediate treatment group~     or a delayed treatment group. The primary outcome includes a change in total and subscale~     scores on the Recovery Assessment Scale. Qualitative interviews with various stakeholders~     will explore issues relating to successful implementation.~   "
51186|NCT02896881|"~     In previous studies exploring specific sequences of MRI (susceptibility weighted imaging~     (SWI) and arterial spin labeling (ASL)), the investigators have shown the great sensibility~     of these MRI sequences to detect arteriovenous shunts, compared to angiography imaging~     (static or dynamic).~      This prospective study aims to compare multisequence MRI to brain arteriography imaging in~     patients undergoing brain arteriovenous malformations embolization.~   "
51187|NCT02896868|"~     The main purpose of this study is to investigate the safety and tolerability of the study~     drug known as LY3041658 in participants with certain types of skin diseases. The study will~     measure how the body absorbs, breaks down and gets rid of LY3041658. It will last about 127~     days for each participant, not including screening. This study is for research purposes only,~     and is not intended to treat any medical condition.~   "
51188|NCT02896855|"~     This Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial in~     China will evaluate the efficacy and safety of pertuzumab + trastuzumab + docetaxel compared~     with placebo + trastuzumab + docetaxel in participants with previously untreated~     HER2-positive MBC.~   "
51189|NCT02896842|"~     Imatinib mesylate (Gleevec/Glivec, IM) is currently the gold standard or CML-CP front line~     therapy. The recommended dose of IM is 400 mg/day. The rates of complete cytogenetic~     responses at 3, 6 and 12 months are 27%, 50% and 69% respectively. The optimal IM daily dose~     is not yet determined and randomized studies addressing this question are on-going. First~     results from the TOPS trial (EHA 2008 congress) suggest a more rapid kinetic of response for~     patients treated with imatinib high dose. Recent studies revealed that initial Imatinib~     plasmatic dosage is predictive for achieving complete cytogenetic responses (CCR) and that a~     dosage of 1000 ng/ml is associated with a higher proportion of major molecular responses~     (MMR) (Picard et al., Blood 2007, Larson et al. Blood 2007).~      Results from the study of Larson et al. indicate that around 40% of the patients had a trough~     plasmatic level below 1000 ng/ml after day 28 of imatinib 400 mg/d. The major molecular~     response rate at 12 months for the patients with the lower plasmatic through level is 25.4%~     compared to 40.1% for the patients with a plasmatic dosage over 800 to 1000 ng/ml.~      Investigators propose to adapt the imatinib daily dose in case of imatinib through plasmatic~     level at day 28 below 1000 ng/ml. Patients with a trough plasmatic dosage ≤ 1000 ng/ml will~     be randomized between a prospective adaptation strategy of the imatinib daily dose (cohort 1)~     versus observation only (cohort 2). The patients with adequate imatinib dosage (> 1000 ng/ml)~     will be followed up according the ELN recommendation (cohort 3). Imatinib trough plasmatic~     level will then be rechecked every month thereafter for patients in cohort 1 and cohort 2 and~     every three months in cohort 3. The first endpoint of the study will be the rate of major~     molecular response at 12 months in cohort 1. Our hypothesis is to improve the 12 months MMR~     rate with the optimized strategy (cohort 1) from 25% of MMR at 12 months to 40% of MMR at 12~     months.~   "
51190|NCT02896829|"~     It's an observational study based on 98 patients included in the STIM trial to extend the~     monitoring of patients and to have molecular and clinical data, with long follow up. Are~     there late relapses? What has become patients who relapsed during STIM trial and restarted~     TKI (inhibitor tyrosine kinase) treatment?~   "
51191|NCT02896816|"~     Study Purpose:~      Parkinson's disease leads to severally impaired motor control. The purpose of this study is~     to better understand and analyze the characteristics of arm muscle activity while doing some~     reaching tasks and of leg muscles while walking. This will allow the investigators to improve~     understanding of the mechanisms underlying the motor impairments in Parkinson's disease.~   "
51192|NCT02896803|"~     Patients with locally advanced or metastatic pancreatic adenocarcinoma not eligible for~     infusional fluorouracil, irinotecan and oxaliplatin (FOLFIRINOX) (PPS 2 or~     hyperbilirubinemia, among other causes) will be treated with mFLOX regimen (fluorouracil~     bolus and oxaliplatin). The primary endpoint is to assess the objective response rate~     according to RECIST criteria (version 1.1) and the secondary endpoints are time until~     clinical or radiological progression, overall survival, toxicity profile.~   "
51193|NCT02896790|"~     The use of oral targeted therapies draws new medical management but also new practices for~     the patients (compliance), their family and the healthcare professionals [1,2]. These~     therapies have sometimes heavy toxicity: side effects to identify, to treat, and for the~     patient to learn to manage. This situation underlines the importance of a therapeutic~     education to accompany this learning [3]. Nevertheless, in France, the therapeutic~     educational programs, built according to the standards of the therapeutic education (TE),~     are still very rare in cancer research [4]. In May 2012, a therapeutic educational program~     for these patients has been developed in the oncology department of the Teaching Hospital of~     Bordeaux through a multidisciplinary team. This program, dedicated to metastatic renal cancer~     patients treated by oral targeted therapies, becomes here an object of research: MODAP~     (action-research).~   "
51194|NCT02896777|"~     The culturing human embryo in vitro is a process of myriad contributing elements. From these~     factors is the pH of embryo culture media, which is crucial for embryo development. The~     investigators plan to examine three different pH values of the culture media on the live~     birth rate of in vitro cultured human embryos.~   "
51195|NCT02896764|"~     Cone beam computed tomography (CBCT), is a recent medical imaging technique where the X-rays~     are divergent, forming a cone.~      As a result, this technique is less irradiating that the scanner. The purpose of this~     exploratory study is to compare the performance of the scanner and the cone beam in the~     detection of anatomical structures of the ear.~   "
51196|NCT02896751|"~     This is a small pilot study to look at the feasibility of creating a customized sleep mask~     for use with Continuous Positive Airway Pressure (CPAP) or other similar treatments for sleep~     apnea. The participant will have three dimensional (3D) pictures of the face taken by special~     cameras. The pictures will be sent to a 3D printer and a mask will be created based on the~     participant's face contours. The participant will use the mask for about 6 months. The study~     will measure the amount it is used during sleep and if there is an increase in reported~     comfort.~   "
51197|NCT02896738|"~     This pilot study aims to assess the interest to add an auditory pathway morphological~     analysis during the MRI exploration of visual pathway in visually impaired children.~   "
51198|NCT02896725|"~     Venous leg ulcers (VLU) are the most common leg ulcer, can be painful, and limit work,~     lifestyles and activity, especially in older patients. Compression bandaging is the main~     treatment but there are few added treatments for patients with slow healing VLU. About 50% of~     patients with VLU may be slow healing. Research suggests using keratin dressings as well as~     using compression may help healing in patients with show healing VLU, but the current~     evidence is not enough to change clinical practice. The investigators will conduct a~     randomised controlled trial to test whether using keratin dressings is better than usual care~     for slow healing VLU.~   "
51210|NCT02896569|"~     The purpose of this study is to compare the tolerability of the application of a combination~     of a serum containing human bone marrow stem cell derived growth factor (SCR Complex) and~     cytokines and a botanical lipid-based occlusive (Bio Cel) immediately following fractional~     radiofrequency treatment using the Venus Viva versus standard of care.~   "
51199|NCT02896712|"~     First, the investigators will determine whether Acceptance and Commitment Therapy in~     combination with Contingency Management increases initial treatment response rates.~      Second, for patients who do not respond to initial treatment, the investigators will examine~     whether dopamine-targeted pharmacotherapy is an effective augmentation strategy.~      Third, for patients who respond to initial treatment, the investigators will assess the~     relative benefit of continued treatment with Acceptance and Commitment Therapy in combination~     with Contingency Management, as compared to Drug Counseling in combination with Contingency~     Management, to prevent relapse.~   "
51200|NCT02896699|"~     This study will evaluate the feasibility of a network intervention to train individuals to~     disseminate PrEP information and motivate initial PrEP interest and knowledge of PrEP in~     their social networks.~   "
51201|NCT02896686|"~     The aim of the present study is to determine the efficacy of the placement of an onlay mesh~     to prevent incisional hernia after loop ileostomy closure in patients with a prior rectal~     resection for cancer~   "
51202|NCT02896673|"~     Acute respiratory distress syndrome remains a serious condition, with a mortality rate of~     between 30 and 50%. The use of mechanical ventilation with small tidal volumes, and by~     limiting the plateau pressure in the respiratory tract below 30 cm H2O has been shown to~     reduce mortality by approximately 10%, probably by reducing pulmonary hyperinflation and~     pulmonary lesions induced by mechanical ventilation. It is therefore now established that the~     respirator settings influence patient prognosis. However, around 30% of patients with ARDS~     ventilated with these settings supposedly protective continue to present signs of pulmonary~     hyperinflation on tomodensitometry, suggesting an additional reduction in the tidal volume~     could be required in certain patients. Electrical impedance tomography (EIT) is a new imaging~     technique that gathers functional pulmonary information at bedside.~      This technique also allows a regional analysis, allowing the complexity of the spatial~     distribution of ARDS pulmonary lesions to be understood. The hypothesis is that EIT is a~     reliable method to detect at-risk situations of lesions induced by mechanical ventilation~     among patients with ARDS.~   "
51203|NCT02896660|"~     HITLAB will conduct a crossover study wherein participants will be asked to wear an~     actigraphy device continuously for 12 weeks. The first four weeks of the study participants~     will continue their previously scheduled treatment regimen, prior to receiving the Probuphine~     implant. Following four weeks of activity and sleep baseline monitoring using the actigraphy~     device, the participant will receive the Probuphine implant as part of their regularly~     scheduled treatment plan. Observation of the participant's activity levels will continue for~     eight weeks following implantation of Probuphine. Actigraphy measurements will include total~     time asleep, total time awake, sleep efficiency, and time mobile.~   "
51204|NCT02896647|"~     This study aims to assess the interest of 3D Phase Sensitive Inversion Recuperation~     (PSIR)sequence in the MRI detection of spinal cord lesion. It will compare the sensitivity of~     this MRI sequence compared to the T1 and T2 sequences recommended in the assessment of~     neuraxis inflammatory diseases.~   "
51205|NCT02896634|"~     Dried Blood Spot or DBS is a collection of blood capillary drops spotted and dried on to a~     filter paper used for different bioanalysis. In comparison to conventional blood testing, DBS~     offers practical, analytical, clinical and financial advantages. This less invasive sampling~     is already used in infectious diseases screening and is useful for persons with poor venous~     (babies, drug users or elderly). Mass-spectrometry-based analyses allow protein~     quantification on very low amount of blood sample. In the project we combine the two~     approaches to measure on DBS blood proteins with clinical relevance -including many FDA~     approves biomarkers). The detection of the relevant clinical analytes will be validated on~     available patient samples in accordance with the clinical norm ISO15189 and the requirement~     for CE IVD marking. This will allow commercial developments (kits, protocols...) realized~     with the industrial partner Spot-to-lab~   "
51206|NCT02896621|"~     The investigators investigated diastolic function among patients with obstructive sleep apnea~     (OSA) and hypertension stage I. In this randomized controlled trial, participants were~     randomly allocated to one of two groups: chlorthalidone associated with amiloride or~     amlodipine. Randomization was carried out prior to the start of the trial by an~     epidemiologist out of clinic and the randomization list was stratified by gender and severity~     of OSA. The research team and participants were blinded to the randomization list and~     allocation concealment was implemented. This trial aimed to detect changes in the~     echocardiography parameters with the drug treatment (higher in the intervention than in the~     placebo group). The investigators also assess change in daytime sleepiness among participants~     who already have been diagnosed with OSA.~   "
51207|NCT02896608|"~     This study addresses the changes in the axonal excitability parameters. It will compare these~     changes in patients with early infantile epileptic encephalopathy with HCN1 channel mutation~     and in control patients, with and without epilepsy.~   "
51208|NCT02896595|"~     In recent years it has been shown that catheter ablation of symptomatic atrial fibrillation~     (PAF) is superior to antiarrhythmic drug therapy with regards to effectiveness and clinical~     outcomes. Atrial fibrillation is the most common cardiac arrhythmia, with high rates of~     concomitant heart failure, stroke and mortality. During an ablation procedure, a patient can~     be managed with intravenous sedation or General Anesthesia (GA). Within this setting, General~     anesthesia is associated with improved procedure time and cure rate compared to sedation.~      Airway management during GA can be achieved through a laryngeal mask airway (LMA) or an~     endotracheal tube (ETT). The use of LMA compared to ETT has been shown in different surgical~     populations to decrease procedure and recovery time, improve hemodynamic stability and reduce~     anesthetic requirements. It has also shown to decrease airway complications, and~     postoperative nausea/vomiting which are important factors that affect overall patient~     satisfaction.~      Although general anesthesia in electrophysiology procedures is associated with a higher cure~     rate, there have been reports of increased airway trauma.Additionally, it is believed that~     volatile anesthetics may be associated with increased ventricular action potential duration~     as well as prolonged QT interval. The increased usage of opioids during general anesthesia is~     also thought to interfere with electrophysiology studies by affecting vagal tone.~      At Virginia Commonwelath University (VCU) Health system, Anesthesiologists have been~     successfully using LMA (General Anesthesia) for ablation in PAF in eligible patients for over~     five years. The investigators plan to perform a retrospective review of all patients who~     underwent catheter ablation of PAF at Virginia Commonwealth University Health System from~     January 2014 - December 2015. The primary endpoint evaluated will be procedure time. Other~     data collected will include demographics, cardiac history, type of anesthesia, amount of~     intra-procedure opioids, time to discharge from post anesthesia care unit (PACU), total~     length of hospital stay, intra-procedure hemodynamics, intra-procedure~     ionotrope/chronotrope/pressor requirements. and atrial fibrillation recurrence at a 3 month~     follow-up.~   "
51211|NCT02896556|"~     The purpose of this study is to evaluate the esthetic performance of resin infiltration~     technique on superficial hypo-mineralized and demineralized enamel lesions of anterior teeth~   "
51213|NCT02896530|"~     Vascular complications in patients with inflammatory bowel disease (IBD), comprising mainly~     Crohn's disease (CD) and ulcerative colitis (UC), representing 2% extra-intestinal~     complications. In over 60% of cases, these vascular complications of deep venous thrombosis~     (DVT) or pulmonary embolism (PE). Several studies have shown that patients with IBD have a~     risk of venous thromboembolic disease (VTE) increased from 1.5 to 3.5. This risk is closely~     related to disease activity.~   "
51214|NCT02896517|"~     Rhabdomyolysis is a common condition in the UAA. Support is heterogeneous, it is in most~     cases a mass hyperhydration. The idea is to initially with an EPP simultaneously screened for~     the most affected by this disease and aggravating factors population, associated~     comorbidities.~      The rhabdomyolysis prognosis depends mainly on the etiology and associated comorbidities.~        -  Acute renal failure and hyperkalemia are the major complications that worsen the~          prognosis.~        -  In most cases, acute renal failure is reversible. Acute renal failure caused by renal~          vasoconstriction with ischemia, precipitation of myoglobin in the tubules and direct~          cytotoxic action of myoglobin.~      If the prime mover of rhabdomyolysis is ischemia (or hypoxia) cell, we now know that the~     tissue damage is greatly aggravated during muscle reperfusion, creating ischemia-reperfusion.~     Reperfusion will not only cause the release into the bloodstream of the cell contents~     myocytes but also an increase in necrotic areas. Indeed, the massive arrival of oxygen at the~     myocyte will cause significant production of free radicals, increasing their toxic effects.~      Predictive factors of acute renal failure is creatinine and urea. The urine alkalinisation by~     bicarbonates is questionable oral alkalizing seems to be an alternative when possible (oral~     alkaline solution) but not used to this day.~      The track N-acetyl cysteine as an antioxidant that can possibly have an effect on release of~     the free radicals during reperfusion by decreasing their toxicity is still not considered~     clinically.~   "
51215|NCT02896504|"~     Some cancer patients report experiencing mild problems with thinking during or following~     chemotherapy. Symptoms include problems concentrating, slow thinking, some gaps in memory and~     difficulty performing complex or multi-tasks. These symptoms often soon disappear after~     treatment. However for some patients, they may persist for years and this can have a~     significant effect on their quality of life. The reasons for these symptoms are not well~     understood.~      This study proposes to examine the effects of chemotherapy on the brain and how the changes~     in the brain affect one's ability to move one's arms and fingers. By better understanding the~     negative consequences of chemotherapy on the brain and nervous system, the hope is to help~     pharmaceutical companies develop safer cancer treatment drugs.~   "
51216|NCT02896491|"~     To investigate possible effects of radio frequency electromagnetic fields on EEG activity~     during sleep and on Brain function during wake (EEG in the resting state condition, slow EEG~     potentials, auditory evoked potentials) and cognitive performance measures in test of~     selective attention, divided attention and working memory in healthy elderly males (60 - 80~     years).~   "
51217|NCT02896478|"~     The path of a patient depends largely on his health care network, that is to say of the~     interrelationships between health professionals who will be involved throughout his career.~     At the hospital, the transition points in the care process is a vulnerable time for the~     patient regarding the continuity of his medication. These transition points are the intake,~     the transfer and the outlet. In town, our health system must be able to build on the~     inter-city hospital, warranty essential guarantee of the continuity of care. However, there~     is often a breakdown in this relationship with more or less serious consequences ranging from~     simple dissatisfaction of the patient, to the realization of duplicate examinations or the~     use unjustified emergency and re-hospitalization. Medication errors can occur, resulting from~     incomplete information or poorly communicated in this city hospital interface.~      The city hospital dysfunctions are mainly organizational, hospital being rather specialized~     therapeutic approach centered on pathology and medicine city instead focuses on a patient's~     overall approach.~      The involvement of the pharmacist in the hospital, as the city is an interesting axis to~     develop. In town, the pharmaceutical nomadism, including in major cities remains low,~     patients generally have a dedicated pharmacies for the treatment of their serious or chronic~     pathologies. The development of the pharmaceutical dossier today allows the pharmacies to~     access the history and the entire therapy of patients prescribed to town by different~     specialists and general practitioners, on the last 4 months. Its recent availability within~     our hospital Group allows us to consider its use to fully optimize the patient's drug~     monitoring.~   "
51218|NCT02896465|"~     Assessment of the impact of oral Human Milk Oligosaccharides (HMO) application on acute~     diarrhoea and the development of prolonged and persistent diarrhoea in paediatric patients~     hospitalized with acute diarrhoea.~   "
51219|NCT02896452|"~     The investigators have documented a genetic predisposition for some astronauts to develop~     ophthalmologic issues (e.g., choroidal folds, cotton wool spots, optic disc edema). Women~     with polycystic ovary syndrome (PCOS) have several characteristics similar to those described~     in astronauts, including: higher homocysteine concentrations, increased incidence of~     intracranial hypertension, increased retinal nerve fiber layer thickness, increased incidence~     of white matter hyperintensities on MRI, increased androgen concentrations (or androgen~     responses to space flight), and indices of altered carbohydrate metabolism. Women with PCOS~     have not been evaluated in detail regarding the occurrence of other anomalies observed in~     astronauts including choroidal folds, optic disc edema and cotton wool spots as well as~     changes in cycloplegic refraction, and optic nerve sheath diameter. While researchers have~     evaluated one-carbon metabolism pathway polymorphisms re: PCOS, and initial studies show an~     association with certain one-carbon polymorphisms, none have looked at the complete set of~     SNPs proposed here. This study will evaluate women with PCOS and/or idiopathic intracranial~     hypertension (IIH) to assess one-carbon biochemistry and genetics and their possible~     correlation with ophthalmologic findings. The investigators aim to clarify the relationship~     of one carbon metabolism and ophthalmic findings in astronauts and patients with PCOS and/or~     IIH.~   "
51310|NCT02895269|"~     COSIMPO is a randomised controlled trial in which a collaborative shared care for psychosis~     implemented by complementary alternative providers (traditional and faith healers) and~     conventional primary health care providers (PHCP) is compared with care as usual in which no~     formal collaboration takes place between the two groups of health providers. COSIMPO is~     therefore a test of a complex task sharing approach for the care of patients with severe~     mental disorders.~   "
51220|NCT02896439|"~     Pelvic fractures in which integrate the acetabulum fractures represent a risk of traumatic~     injury to the sciatic nerve trunk by stretching or section (1): Judet and Letournel reported~     a complication rate of around 6% (1). Fractures of the acetabulum strictly speaking are also~     providers of neurological complications with rates, significant, have recently been precisely~     detailed by a cohort study published by Lehmann et al. (2): In a series of 2073 patients, the~     authors reported an overall complication rate of neurological related to the initial trauma~     of the order of 4%. In this series, 1395 patients were operated with a rate of iatrogenic~     neurological complications of 2 to 3%. Regarding the first routes (and therefore the types of~     fractures), the Kocher-Langenbeck path is the path that leads to the greatest number of~     neurological complications: 3 to 4% in this series (2). However, this cohort study does not~     specify what truncal achievement it is. Obviously violations posterior acetabular are~     preferentially providers of sciatic injury while violations prior acetabular are more~     providers of obturator or femoral lesions. But this is not always the case. Moreover, this~     study does not specify the type or severity of neurological involvement.~   "
51221|NCT02896426|"~     The main objectives of this study are to evaluate the feasibility, acceptability, and effects~     of a CPS parent group on outcomes for a sample of parents of children ages 3 to 5 compared to~     outcomes after attending a parenting group that promotes behavioral (operant) parenting. We~     hypothesize that guardians in the CPS group will report a better understanding of how~     neurocognitive skills relate to children's behaviors, greater improvements in child~     functioning and behavior, and greater reductions in parents' stress than those in the~     comparison group.~   "
51222|NCT02896413|"~     Surgical stress and anesthesia may cause immunosuppression in immunocompromised cancer~     patients. The natural killer (NK) cell is a critical part of anti-tumor immunity.~     Dexmedetomidine has sympatholytic effect and preserves NK cell function. This study~     investigate the effect of dexmedetomidine on immune suppression and postoperative outcomes in~     patients undergoing uterine cancer resection.~   "
51223|NCT02896400|"~     The investigators propose an innovative full-factorial design in a cohort of 1056 adult~     smokers in an urban emergency department (ED), to test the efficacy of four key intervention~     components: motivational interviewing, medication, quitline referral, and texting. At the~     trial's completion, a mixed-methods approach will be used to identify the components that~     were efficacious within the proposed cost constraint, along with feasibility and~     acceptability to providers and subjects. The investigators will then assemble an intervention~     that maximizes efficacy, given a cost-effectiveness constraint and findings from a~     qualitative analysis.~   "
51224|NCT02896387|"~     Ectodermal dysplasia associated with p63 is a rare disease which, in addition to limbic~     abnormalities, primarily affects the skin and cornea. The most common forms are called~     Ectrodactyly, Ectodermal dysplasia, palate Key for cleft lip and palate (EEC) and~     Ankyloblepharon, Ectodermal dysplasia, cleft lip and palate (AEC). Apart from symptomatic~     treatment, no cure is available. To understand the molecular defects associated with this~     disease and to identify therapeutic tools, a research team modelized the disease by~     reprograming EEC and AEC patient fibroblasts in pluripotent stem cells (iPSC), then induced~     iPSC differentiation in patients and controls epidermal (skin) and limbic (cornea) cells and~     demonstrated that the mutated cells can reproduce in vitro the abnormalities observed in~     patients.~      P63 gene belongs to the family of p53 gene. The functions of the two proteins are very~     similar. Data suggest that molecule Prima could reactivate the p63 protein mutated in~     patients and thus alleviate skin defect healing and limbic regeneration.~   "
51225|NCT02896374|"~     Case-control comparison of clinical population, interventional and single-center research.~   "
51226|NCT02896361|"~     This purpose of this study is to evaluate the therapeutic efficacy of burst microdosing~     stimulation paradigms in patients with chronic pain.~   "
51227|NCT02896348|"~     The goal of this study is to explore if the SynPhNe system can be used without difficulties~     in the home setting for upper extremity rehabilitation therapy for people who suffered a~     stroke.~   "
51228|NCT02896335|"~     This research study is studying palbociclib as a possible treatment for recurrent brain~     metastases.~      - Pfizer, a pharmaceutical company, is supporting this research study by providing the study~     drug as well as funding for research activities~   "
51229|NCT02896322|"~     Accelerated partial breast irradiation with CyberKnife (CK-APBI) is a promising innovative~     approach for early breast cancer after conservative surgery, for addressing the need of a~     radiotherapy target only to the surgical cavity in selected patients, exceeding the limits of~     other PBI/APBI.~   "
51230|NCT02896309|"~     This study evaluates the effect of oral sodium bicarbonate treatment on the intrarenal~     renin-angiotensin-system in adult patients with a metabolic acidosis and chronic kidney~     disease. This treatment is compared to sodium chloride treatment, which serves as control for~     increased sodium-intake and no treatment, which serves as time-control.~   "
51231|NCT02896296|"~     Study is to provide ongoing treatment with RBP-6000 and safety monitoring for subjects who~     complete the RB-US-13-0003 study and for whom a new treatment venue has not been identified.~   "
51232|NCT02896283|"~     The aim of this randomized split-mouth design clinical trial is to clinically evaluate the~     effectiveness of diode laser in the healing of donor site of palate in free gingival graft.~   "
51233|NCT02896270|"~     The trial investigates the use of VPA (Valproic Acid) for the treatment of adult patients~     with biopsy proven idiopathic focal segmentel glomerulosclerosis (FSGS) or minimal change~     disease (MCD).~      VPA used as an add-on to steroids might induce clinical remission in a first category of~     patients and potentially reduce the dose of maintenance immunosuppression required to~     maintain remission thereafter.~      In a second category of patients VPA might allow the reduction or even cessation of~     immunosuppression while clinical remission is maintained.~   "
51234|NCT02896257|"~     This Quality Enhancement Research Initiative (QuERI) is designed to determine efficacy and~     acceptance of an intervention method to provide primary care providers with patient-tailored~     electronic consults and corresponding unsigned orders for de-implementation of inhaled~     corticosteroids (ICS) for patients with COPD when ICS are not indicated by guidelines.~   "
52043|NCT02885701|"~     The purpose of this study is to determine if any difference exists among 3 different~     postoperative splinting regimens- no splint, removable splint, and plaster non-removable~     splint- following mini-open carpal tunnel release (CTR) surgery.~   "
51235|NCT02896244|"~     During or after antibiotic treatment, antibiotic residues impair the intestinal microbiota~     (gut flora) and lead to adverse effects such as the emergence of bacterial resistance or the~     occurrence antibiotic-associated diarrhoea (AAD) including antibiotic-induced C. difficile~     infection (CDI). The spread of resistant Gram-negative bacteria and the increasing number and~     severity of CDI are considered as worldwide public health threats.~      Da Volterra is a biotechnology company developing a novel product, DAV132 (a medical device~     in Europe), intended to prevent these antibiotic adverse effects. Da Volterra is planning to~     carry out a phase 2-3 randomized controlled trial (RCT) of DAV132 in the prevention of~     antibiotic-induced CDI. The RCT will involve hospitalized patients aged ≥50 years old and~     treated with predefined antibiotic classes known to increase the risk of CDI. The incidence~     of CDI in this population is unknown, yet, incidence is an important determinant for the~     required sample size.~      Therefore, the main objective of the current study is to assess CDI incidence in patients ≥50~     years of age treated with predefined antibiotic classes.~      In addition, to optimise the target population of the DAV132 RCT, the effect of the~     predefined antibiotic agents on the intestinal microbiota will be assessed. Furthermore,~     biomarkers predictive of CDI occurrence might help identify patients at high risk for the~     disease, which could further optimise the RCT. No validated biomarkers have been described in~     the literature yet. Assessment of potential biomarkers is another aim of the present study.~   "
51236|NCT02896231|"~     This phase I, first-in-human dose-escalation study was conducted to determine the maximum~     tolerated dose (MTD), recommended phase II dose (RP2D), dose-limiting toxicities (DLTs),~     pharmacokinetics (PK) profile, and preliminary antitumor activity of PLB1001.~   "
51237|NCT02896218|"~     Vancomycin is a glycopeptide antibiotic that is the first line antibiotics for the treatment~     of serious gram-positive infections involving methicillin-resistant Staphylococcus aureus~     (MRSA). Its therapeutic window is narrow, so there is a need to monitor serum vancomycin~     concentration in clinical practice, especially in the critically ill patients. So far, few~     studies have investigated the clinical outcomes of the dosage strategy that vancomycin dosage~     is administered and adjusted individually using PPK and Bayesian methods based on observed~     concentrations. The objective of this study is to investigate the effectiveness, safety and~     economics of the vancomycin individualized dosing service provided by pharmacists.~   "
51238|NCT02896205|"~     Systemic sclerosis is a multisystem disease and can involve the lungs in the form of ILD.~     Lung involvement is the most common cause of death in these patients. The present study is~     performed to study the efficacy of oral mycophenolate mofetil in treating early and mild ILD~     in patients of SSc. The efficacy and side effects of mycophenolate mofetil will be compared~     with that of oral placebo.~   "
51239|NCT02896192|"~     The purpose of the study is to determine the effect of setmelanotide (RM-493) on weight and~     other factors in patients with pro-opiomelanocortin (POMC) deficiency obesity due to rare~     bi-allelic loss-of function POMC or PCSK1 genetic mutations.~   "
51240|NCT02896179|"~     Multiple Sclerosis (MS), the most common non-traumatic cause of neurologic disability in~     young adults, affects mobility and ambulation in the majority of patients. Nearly 50% of~     persons with MS will require an assistive device to ambulate within 10 years of diagnosis. A~     subgroup of MS is Primary Progressive MS, which manifests with gait disturbances over 80% of~     patients in the long term. In addition to altered gait, nearly 70% of patients will~     experience cognitive deficits during the course of the disease. Therefore, actions that~     facilitate patient involvement in finding solutions for personalized management of disease~     and disability are needed.~      Although immunomodulatory drugs offer some benefit in other types of Multiple Sclerosis,~     there is currently no effective treatment for Primary Progressive MS. A fundamental goal in~     the management of persons with MS is to maximize their ability to ambulate and perform safe~     and effective transfers in everyday life.~      In the last decade, research has increasingly centered on the effects of robot devices in the~     rehabilitation of patients with neurological diseases. This has led to the development of new~     robot-assisted gait devices engendered by virtual-reality systems, and several studies have~     demonstrated the positive effects that these devices have on gait endurance and quality of~     life in patients with neurological diseases and disability.~      The aim of this project is to develop and study the effects of a novel, cognitively intensive~     virtual-reality -based rehabilitation software application that simulates a real-world~     environment where a person can walk. The virtual-reality application is an upgrade version~     synchronized to a robotic device, the GEO System. The second aim is to compare the cognitive~     and motor effects of robot-assisted gait training with this application against training with~     robot-assisted gait training without virtual reality.~      The experimental group will receive robot-assisted gait training with the virtual-reality~     application and the control group will receive robot-assisted gait training All subjects will~     undergo training for 6 weeks (2 sessions/week) for a total of 12 sessions. Assessments before~     training, after training, and at follow-up will be performed using clinical and instrumental~     tests to compare the effects of training.~      Successful completion of the study may help patients to alleviate the impact of disability,~     increase their independence in activities of daily life, and improve their quality of life.~     Through new rehabilitative strategies that combine cognitive and motor training involving~     higher brain functions and motivation, patients will be stimulated to walk in a reality-based~     environment.~   "
51241|NCT02896166|"~     Lung cancer, the leading cause of cancer related mortality. Among them, non small cell lung~     cancer accounts for 85%. Only part of patients could be treated with radical surgery, and~     some patients were unfit for surgery due to the poor cardio-pulmonary function or refuse~     surgery. For those patients, microwave ablation (MWA) could be an alternative treatment.~     Several small sample retrospective studies verified that MWA could be an efficacy and safe~     treatment.~   "
51242|NCT02896153|"~     In France, consumption of hypnotic drugs is high. In this context, and given the planned~     regulatory modifications, it seems essential to make an inventory of the consumption of drugs~     taken for a hypnotic purpose. This study aims to identify the substances (medical or not)~     used for a hypnotic purpose in the adult population going to a pharmacy.~   "
51243|NCT02896140|"~     The aim of this study is to determine the relationship between the percentage of calories~     from dairy intake and long-term glycemic control and weight maintenance in patients with type~     2 diabetes who participate in an intensive lifestyle intervention program.~      The investigators hypothesize that overweight and obese patients with type 2 diabetes who~     consume higher percentage of calories from dairy products during intensive lifestyle~     intervention programs have better glycemic control and maintenance of weight loss as compared~     to those who consume lower percentage of calories from dairy products.~   "
51244|NCT02896127|"~     To demonstrate the clinical efficacy, safety and tolerability of secukinumab compared to~     placebo in patients with ankylosing spondylitis at Week 16 and long term efficacy and safety~     up to Week 52.~   "
51245|NCT02896114|"~     The study aims to evaluate the current methods of surgical treatment for Congenital~     Pseudarthrosis of tibia(CPT) in children and their results respectively.~   "
51246|NCT02896101|"~     This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study~     to Evaluate the Therapeutic Equivalence of a Generic Pimecrolimus Cream, 1% (Glenmark~     Pharmaceuticals Ltd) to the Marketed Product ELIDEL® (pimecrolimus) Cream, 1% (Valeant~     Pharmaceuticals North America LLC) in the Treatment of Mild to Moderate Atopic Dermatitis~     (AD).~   "
51247|NCT02896088|"~     Currently, the real scope of sealants (AS) is poorly documented in temporary dentition and~     its effectiveness has not been demonstrated. Yet it seems reasonable that the AS in temporary~     dentition could slow the specific development of carious lesions in early childhood. In~     addition, this non-invasive approach could delay the conventional food and thus save~     financial costs for more complex treatments. Finally, the installation of AS could afford, as~     demonstrated in adult teeth, lowering the cariogenic bacteria prevalence engaged in the~     caries process.~   "
51248|NCT02896075|"~     The purpose of this study is first to investigate the effect of a controlled intervention~     with a comedy video on pain tolerance in a social setting while quantitatively measuring~     laughter in a young healthy population experiencing delayed onset muscle soreness. The comedy~     intervention will be compared to a control of watching a documentary. The second aim is to~     examine to what extent various methods of eliciting pain would cause physiological responses~     that confound the interpretation of a pain stimulus.~   "
51249|NCT02896062|"~     In the present study, a 4-week sleep coaching program is developed and evaluated in members~     of the German armed Forces. The aim of the program is to provide an efficient tool to prevent~     sleep disorders, and to improve mild sleep disorders, with a special focus on insomnia.~   "
51250|NCT02896049|"~     Based on the basic data of all patients foreseen for a local hyperthermia in the~     participating centers the failure rate (of the Celsius TCS Hyperthermia System) and the~     complication rate (injury to the patients) will be recorded.~   "
51251|NCT02896036|"~     Purpose: The primary objective is to compare the time required for adequate intraperitoneal~     insufflation (from skin incision to reaching intraperitoneal pressure of 15 mmHg). Also the~     number of attempts needed before successful entry is achieved. The secondary objectives will~     evaluate rates of secondary outcomes measures such as; failed entry, extra peritoneal~     insufflation, vascular injury, visceral injury, gas embolism, solid organ injury, and omental~     injury between the two techniques.~      Study design: prospective randomized control trial~      Hypothesis: The investigators hypothesize that participant's undergoing laparoscopic surgery~     for benign Gynecologic indications at TGH who undergo laparoscopic entry technique of Veress~     needle entry with concomitant CO2 insufflation will require less time to achieve a 15 mmHg of~     intraperitoneal pressure as opposed to Veress needle entry with subsequent CO2 insufflation,~     and will require less number of attempts to achieve successful entry.~   "
51252|NCT02896023|"~     Patients will be subjected to:~      A. Clinical evaluation including history and examination~      B. Ultrasonographic evaluation of Ovarian Morphometry:~        -  Patients will be evaluated in early follicular phase of the menstrual flow (cycle's days~          1-3) by TVS scanning; using MINDRAY DP-1100 Plus Digital Machine, 7.5MHz, China, by only~          one examiner to avoid inter-observer variations.~        -  Ovarian images will be procured in the sagittal and coronal planes and the frozen image~          reflecting the largest ovarian dimensions will be utilized for the measurement of~          ovarian length, width, and height (cm) as per standard clinical practice. Mean values of~          both ovaries will be used. Ovarian volume will be calculated from ellipsoid volume~          formula, {Ovarian volume = Ovarian Width (D1) × Ovarian Length (D2) ×Ovarian Height (D3)~          × 0 .523}~        -  Antral follicle count will be determined for each patient~      C. Laboratory Evaluation:~      Blood samples will be collected in the early follicular phase. Samples will be immediately~     centrifuged and serum saved at -20 degrees for measurement of:~        -  Anti Mullerian Hormone (AMH)~        -  Follicle Stimulating Hormone (FSH)~        -  Estradiol (E2) Using electro-chemiluminescence immunoassay (ELICA)~   "
51253|NCT02896010|"~     Sweetch is a personalized mobile-health platform coaching system (mobile phone app) designed~     to promote adherence to physical activity guidelines for people with prediabetes.~   "
51254|NCT02895997|"~     The purpose of the study is to determine if temporarily relocating clinicians who deliver~     remote care using the eICU telehealth system to Sydney, Australia will lead to greater job~     satisfaction, reduced physiologic stress, and improve performance. Four nurses and six~     physicians will be sent to a site in Sydney Australia on a rotating basis to determine~     whether providing care during the Australian daytime is more efficient and precise than~     providing care during the night in the United States.~   "
51255|NCT02895984|"~     Alcohol use is almost ubiquitous on college campuses and first-year students are at~     particularly high risk of alcohol-related harm when they first make the transition to~     college. Peers are important agents in socializing both healthy and unhealthy behaviors, but~     despite the clear role of peer behavior in the maintenance of college problem drinking, there~     have been no efforts to measure the effect of individual change on the reduction of~     alcohol-related risks in the broader student body. That is, despite the importance of social~     connections for inducing and maintaining alcohol use in youth, intervention approaches have~     not measured nor capitalized on the potential of social influences for changing this problem~     behavior. It is essential that we understand the indirect effects of individual interventions~     and the impact such interventions have on the social structure and social connections. The~     best way to evaluate such effects is to use a research design that experimentally manipulates~     drinking using the best available intervention and measures its effects on the social network~     and its members.~      The purpose of this research is to investigate whether using an established individual Brief~     Motivational Intervention (BMI) administered to a small number of influential network members~     embedded in a social network significantly reduces heavy drinking and alcohol consequences~     among close peers who do not receive any intervention (the investigators call this the~     indirect intervention effect). In addition, the investigators will investigate putative~     social influence mechanisms of this transmitted effect, investigate how specific types of~     network connections and relationships moderate the indirect intervention effect, and~     investigate the effects of the intervention on network position and structure. First-year~     students at Brown (N = 1,280) will be enrolled and assessed early in their fall 2016 academic~     semester. Using baseline data, dormitories (N = 10) will be matched on size and randomly~     assigned to one of two conditions: BMI or natural history control (NHC). Heavy drinkers in~     each dormitory who are in the top quartile of betweenness centrality, a social network~     construct that reflects high connectivity and potential influence, will either receive BMI or~     serve as controls, according to their dormitory's intervention assignment. All participants~     will be assessed again 5 and 12 months after baseline to measure changes in behavior and in~     peer ties in the entire network of first-year students. The long-term objective of this~     research is to understand how peer influences function in social networks in order to~     leverage those mechanisms to reduce problematic alcohol use in heavy drinking populations.~   "
51256|NCT02895971|"~     The aim of this study estimate VTE incidence. Investigators prospectively record all cases of~     symptomatic pulmonary embolism (PE) and deep vein thrombosis (DVT) of the lower limbs~     diagnosed between March 1, 2013 and February 28, 2014 in hospitals and in the community.~   "
51257|NCT02895958|"~     Evaluation of Zepatier in a community-based setting among cirrhotic and non-cirrhotic~     patients on stable opiate substitution therapy.~   "
51258|NCT02895945|"~     The purpose of this study is to evaluate the efficacy and safety of BAX 802 in males with~     congenital hemophilia A (CHA) with inhibitors who are undergoing major or minor elective~     surgical, dental, or other invasive procedures.~   "
54581|NCT02852538|"~     This study aims to measure the effect of a neurobiologically-guided intensive family based~     treatment for adults with anorexia nervosa.~   "
51259|NCT02895932|"~     The purpose of this study is to determine if changes in brain serotonin affects the~     accumulation of amyloid in the brain. The investigators will use brain imaging methods to~     measure the amount of serotonin and amyloid in the brain of individuals with Parkinson's~     Disease (PD) and otherwise healthy older people. PD participants will undergo repeat brain~     imaging to assess amyloid accumulation two years after their first brain imaging session. All~     participants will undergo examinations to assess their motor function, and asked questions to~     assess their mood and thinking.~   "
51260|NCT02895919|"~     This study seeks to determine non inferiority of direct inoculation of ascitic fluid in lab~     as compared to current culture media standard, bedside inoculation with blood culture~     bottles.~   "
51261|NCT02895906|"~     This is a 5-week, multi-center, open-label, dose optimization trial in subjects aged 12-17~     years with 22q11DS who have a diagnosis of anxiety disorder, and/or ADHD, and/or ASD.~     Approximately 12 subjects will be initiated, dose optimized, and maintained on NFC-1 over a~     period of 5 weeks.~   "
51262|NCT02895893|"~     The goal of this Phase I study is to conduct a proof-of-concept trial of a contingency~     management (CM) targeting adherence to oral HIV antiretroviral pre-exposure prophylaxis~     (PrEP) administered via a smartphone-based medication adherence platform (PrEP SMART, the~     app).~   "
51263|NCT02895880|"~     The purpose of this study is to collect initial data on what survivors of childhood,~     adolescent, and young adult cancer think of how information about statins is communicated.~     Statins are medications that lower cholesterol. The results of this study will be used to~     improve the communication about statins. This is to aid patients and their providers in~     making health care decisions together, also known as shared decision making.~   "
51264|NCT02895867|"~     This is a randomized prospective clinical study in patients with type 2 diabetes to evaluate~     the effect of dairy products with full or low fat on glycemic control and cardio-metabolic~     risk factors in comparison to a regular diet.~   "
51265|NCT02895854|"~     The aim of this trial is to find out if there are any differences in the profiles of acute~     and late adverse effects among men with low and intermediate risk prostate cancer treated~     either with low dose-rate brachytherapy or hypofractionated external radiotherapy~     (CyberKnife). Also the prostate specific antigen (PSA) responses and cost utility of each~     treatment will be analysed.~   "
51266|NCT02895841|"~     The purpose of this study is to learn more about the ways in which mobile technology can be~     integrated into inpatient care to help better track pain levels using mobile technology of~     patients with sickle cell disease, oncology patients, and bone marrow transplant patients.~     The study will assess whether or not daily mobile monitoring with wearable accelerometers~     (devices that detect movement as well as heart-rate) to monitor and manage medical treatments~     can have a lasting positive impact on outcomes in patients with chronic diseases. The~     investigator hopes to learn more about the ways in which mobile technology can be integrated~     into inpatient care. Specifically, the investigator is looking to help patients better track~     their pain, use wearable technology to track physiological measures (for example, heart rate,~     sleep quantity and quality), and integrate these data points into the medical care of~     patients by providing the information to providers. This study will first gather information~     regarding the feasibility and acceptability of the use of technology on the inpatient unit.~     This will help the study team to refine the technology of the mobile app and logistics of~     integration. Following this, the investigator will complete a second phase of the study,~     during which select patients will pilot the intervention. This will be followed by the third~     and final phase, during which patients will be randomly assigned to the active intervention~     or standard of care. This phase approach will enable the study team to refine the~     intervention, relying on the feedback from patients and providers, and subsequently test its~     utility compared to standard of care through random assignment.~   "
51267|NCT02895828|"~     This study will compare the effects of 2 exercise programs including core stabilization~     exercise and general trunk strengthening exercise programs on trunk muscle activity, physical~     dysfunction, quality of life and lumbar motion in low back pain patient with clinical lumbar~     instability.~   "
51268|NCT02895815|"~     The purpose of the study is to evaluate the efficacy and safety of CNTO 2476 cells~     administered into the subretinal space by the suprachoroidal surgical approach and the~     subretinal access kit (SRAK-02) in participants with visual acuity impairment associated with~     Geographic Atrophy (GA) secondary to Age Related Macular Degeneration (AMD).~   "
51269|NCT02895802|"~     Purpose: To assess the feasibility of using videos depicting people with DS to teach other~     adults with DS to perform healthy behaviors.~      Hypothesis: Videos of adults with DS performing healthy behaviors is a more effective way to~     promote healthy behaviors by adults with DS than other methods tested.~      This project will study whether videos showing a person with DS washing his hands correctly~     can improve hand washing by other adults with DS.~   "
51270|NCT02895789|"~     This proposal will focus on (1) estimating oxidative capacity of specific muscle groups~     during exercise using near infrared spectroscopy and (2) describing body composition to~     better understand exercise capacity and mitochondrial function in ambulatory spinal muscular~     atrophy (SMA) patients and disease controls. It is a 6-month observational study including 14~     ambulatory SMA patients, 14 ambulatory patients with mitochondrial myopathy, and 14 healthy~     controls.~   "
51271|NCT02895776|"~     Thrombectomy is now the standard of care of revascularization in acute ischaemic stroke. Data~     tend to show that final neurologic outcome is superior if the thrombectomy procedure was~     performed under conscious sedation.~      The Rothschild Foundation is a high output centre with more than 400 thrombectomy procedures~     every year.~      We report a rate of 5% of these procedures requiring general anesthesia despite conscious~     sedation being the standard of care. This study aims to identify clinical factors associated~     with a risk of conversion of a conscious sedation to a general anesthesia.~   "
51311|NCT02895256|"~     Cluster headache is a syndrome characterized by disabling headache and accompanying autonomic~     symptoms. Despite cluster headache is called suicide headache, its natural history has not~     been well investigated. The investigators aimed to investigate its disease course, overall~     prognosis, and treatment pattern in retrospective cohort.~   "
51312|NCT02895243|"~     This pilot study will be a clinical trial to test the feasibility and effectiveness of a~     kidney transplant (KT) prehabilitation intervention in adults with end stage renal disease~     (ESRD) who are within 3-6 months of transplantation.~   "
51272|NCT02895763|"~     A Quality work was conducted to enable the future construction of a Quality of Life~     Questionnaire Related to Health (HRQoL) in patients with slowly progressive neuromuscular~     disease (NMD) as myopathies and muscular dystrophies. The discussion group training is an~     effective method to perform a thorough investigation of aspects of HRQoL potentially altered~     by NMD. Patients were recruited in France by 4 reference centers MNMs. All verbal~     interactions between participants focus groups were recorded. A qualitative analysis of the~     transcript was performed. The transcript provided 2424 CIF categories. The results helped to~     identify and quantify aspects of life that are altered by NMDs between patients. A pool of 64~     items and a validated questionnaire (the WHOQOLBREF) were thern passed by 159 patients~     enrolled in eight reference centers MNMs. The investigators constructed a questionnaire~     called QoLNMD which is composed of two general items and 24 items classified into three~     areas: (1) \ Impact bodily symptoms, (2) \ Self-perception and (3) \ Activity~     participation. Each area has good psychometric properties (Cronbach's alpha> 0.77,~     test-retest ICC> 0.81, H Loevinger> 0.41) and met the assumptions of IRT. the comparison with~     the WHOQOL-BREF was used to assess similarities and differences with a generic questionnaire.~     The next step was to validate the QoLNMD reassessing its psychometric properties in a new~     patient sample and calibrate the IRT measurement system. The purpose of these new part of~     study was to validate the French version of the QoL-NMD on a confirmatory sample of patients~     and to calibrate its measurement system. A prospective study in 8 NMD referral centers~     (France) was conducted. Both the QoL-NMD and a validated generic questionnaire (the~     WHOQOLBREF) were administered to patients. 156 patients were included for the confirmatory~     psychometric analysis. All three domains showed adequate psychometric properties and met IRT~     assumptions. The IRT model calibration was then performed successfully on 315 patients. The~     French version of the QoL-NMD showed adequate psychometric properties and can be used in~     rehabilitation services. A conversion table enables easy transformation of sum scores into~     IRT-calibrated measures. Minimum detectable change tables help interpreting score change.~   "
51273|NCT02895750|"~     There is limited data availability on effect of Metformin XR on 24-h plasma glucose, and~     there is no available data in chronic kidney disease (CKD). The planned study aims to provide~     data on glucose plasma level in relation to metformin plasma level in Diabetes Type II~     patients.~   "
51274|NCT02895737|"~     This prospective, randomized study was designed to analyse the difference of cerebral~     embolization in patients undergoing transcatheter aortic valve implantation with~     balloon-expandable vs. self-expandable valves by using a cerebral protection system (Claret~     Sentinel™ Device).~   "
51275|NCT02895724|"~     The purpose of this study is to examine if pressurechamber treatment (HBOT) can reduce early~     stages of breast cancer related lymphedema, and to explore the mechanisms involved in the~     disease progress.~   "
51276|NCT02895711|"~     The purpose of this study is to quantify the radiation exposure from diagnostic testing and~     surgical treatment during routine endourologic procedures for symptomatic urolithiasis.~   "
51277|NCT02895698|"~     The main aim of this study is to investigate the effects of dry cupping on calf muscle~     trigger points in patients with plantar heel pain. A secondary aim is to examine the~     correlation between several outcome measures in those patients.~   "
51278|NCT02895685|"~     The investigators have planned a randomized study, examining the effect of self-directed~     training in groups vs. individual training on trainees' acquisitions of open surgical skills.~      Eighty participants who signed up for a pre-existing simulation-based course in basic open~     surgical skills will be randomized to practice either in pairs or individually during the~     course. Participants open surgical skills will be tested on a simulated skin model before and~     after the course. The investigators hypothesis is that dyad training will enhance~     self-directed learning in open surgical skills.~   "
51279|NCT02895672|"~     This is a real-world, pre-post observational study from an ambulatory endocrinology practice~     which will determine the effectiveness and safety of the addition of glucagon-like~     peptide-1(GLP-1) agonist therapy (weekly exenatide {Bydureon} or daily liraglutide~     {Victoza}), added to the regimens of T2DM patients who have already received a minimum of one~     year of basal insulin therapy. Specifically, the investigators hypothesize that GLP-1 agonist~     therapy added to basal insulin therapy will result in statistically significant improved~     glycemic control and weight loss, with no higher risk of hypoglycemia compared to baseline.~   "
51280|NCT02895659|"~     Background: Currently used crystalloid solutes have a variable composition and may therefore~     influence acid-base status, intra- and extracellular water content and plasma electrolyte~     compositions and have a major impact on organ function and outcome. Despite continuing~     evaluation no superiority of one particular type of fluid has been reached so far. To the~     best of the investigators' knowledge no study in humans has ever assessed whether the type of~     crystalloid fluid given for fluid resuscitation in patients undergoing cardiac surgery has an~     impact on hemodynamic stability and cardiac function so far. Nonetheless in the animal model~     it was shown that the choice of crystalloid fluid may greatly influence cardiac performance~      Primary Aim: In this study the investigators want to clarify whether a balanced type~     acetate-buffered fluid solution in patients undergoing cardiac surgery is associated with~     better hemodynamic stability and cardiac function than a lactate-buffered crystalloid solute.~   "
51281|NCT02895646|"~     Beta-lactam antibiotics include penicillin and cephalosporins and are among the most~     prescribed antibiotics. This category of drugs is the most involved in immediate allergic~     manifestations with 2% reactions in treated subjects and a fatal outcome in 1/50000~     treatments. Reactions are IgE-mediated and have a considerable but unknown genetic origin,~     revealed by studies in groups of different ethnical origins in the same geographical region.~     There are also some families with a high frequency of allergic reactions without identified~     Mendelian inheritance.~      The purpose of this study is to identify predictive risk factors associated to immediate~     allergic reactions against beta-lactam antibiotics with a pangenomic approach.~      A secondary purpose is to identify rare predictive factors with homozygosity mapping and~     exome sequencing in various families with high risk of allergy to beta-lactam antibiotics.~   "
51282|NCT02895633|"~     The purpose is to compare and evaluate multiple functional imaging methods (perfusion,~     diffusion, spectroscopy) for initial benign/malignant characterization of osteoarticular~     tumors and to determine which method or which association of methods could improve non~     invasive tissue characterization.~      Secondary purposes are:~        -  to determine a possible correlation between some parameters and the histological grade~          (FNCLCC)~        -  to suggest a coherent diagnostic imaging approach for osteoarticular tumors.~      The ancillary study will enroll patients needing radiological tumor follow-up. The purpose is~     to identify tools for evaluation of tumor activity and therapeutic response before~     modification of morpho-volumetric data.~   "
51351|NCT02894736|"~     Transcranial Direct Current Stimulation (tDCS) is a novel non-invasive brain stimulation~     treatment that is effective with no significant side effects. It can potentially be~     self-administered by patients in their own homes with remote monitoring, substantially~     reducing treatment costs and increasing accessibility, including to remote areas. This study~     will evaluate the feasibility and efficacy of home-administered tDCS treatment for~     depression.~   "
51283|NCT02895620|"~     Intravesical BCG immunotherapy is used after transurethral resection (TUR) for the prevention~     of recurrence of NMIBC. BCG treatment is usually started a few weeks after TUR and is given~     once a week for 6 weeks. It stimulates immune responses that can destroy bladder cancer cells~     (acute and chronic induced inflammations) and as a consequence causes side effects. The~     investigators postulate that Xpert® test might be used to demonstrate the presence of~     residual (after TURB) or recurrent (during adjuvant treatment) disease at the time of~     intravesical treatment, which could be of very significant impact in the management of this~     complex situation.Urines of BCG treated patients are rich in immune system elements~     (cytokines, lymphocytes,…), this complex inflammatory milieu of urines may interfere with~     urinary biomarkers. This study will allow assessing the effect of the complex inflammatory~     milieu induced by BCG treatment in urines of patients with NMIBC on the Xpert® Bladder cancer~     assay.~   "
51284|NCT02895607|"~     Care in ambulatory surgery (CA) is growing in France, despite lagging behind other countries~     in North or US Europe. Arthroscopic knee surgery is a minimally invasive surgery eligible for~     CA. Currently 71.8% of knee arthroscopy are made in this context. However ligamentoplasties~     anterior cruciate are still carried out predominantly in conventional hospitalization (HC)~     with a median of 3 to 5.5 days of stay.~      Two recent prospective studies French single-operator shows the feasibility of reconstruction~     of the anterior cruciate ligament (ACL) in ambulatory: no serious events were recorded, the~     risks are comparable to those of a HC.~      However, this support requires a structure and a coordinated network between different~     medical and paramedical (surgeons, anesthetists, nurse frame, City nurse, doctor,~     physiotherapist).~      The objective of the study is to evaluate (i.e. EPP or feasibility) ACL reconstruction in~     CA in hospitals, multi-operator.~   "
51285|NCT02895594|"~     Retrospective medical chart review of patients undergoing surgical repair of idiopathic~     macular hole~   "
51286|NCT02895581|"~     Retrospective medical chart review of HIV-infected patients diagnosed with progressive~     multifocal leukoencephalopathy~   "
51287|NCT02895568|"~     This study is to measure prevalence of established and candidate molecular markers of drug~     resistant malaria at Komé, Doba, Republic of Chad.~   "
51288|NCT02895555|"~     The average life expectancy in Denmark is increasing resulting in an increasing part of the~     population having age-related disease, ex lumbar spinal stenosis (LSS). LSS causes~     constriction of the nerves in the lumbar spine resulting in pain in the legs and lower back,~     especially when standing and walking, known as neurogenic claudicatio(Goh KJ FAU - Khalifa et~     al.). LSS occurs in a combination of degenerative changes in the lower back, including~     hypertrophy of the ligamentum flavum, arthrosis of the facet joints and bulging of the disc.~      Current treatment of LSS is varied ranging from non-operativ conservative treatment to~     operation.~      Operative intervention shows very good results according to physical ability and~     pain(Christensen FB et al.;Hee HT and Wong;McGregor AH FAU - Hughes and Hughes;Xu et al.),~     but the most optimal treatment is still debated. Nevertheless, a decompression and, if~     needed, a spinal fusion is recommented.(Ausman).~      The investigators want to se whether i-FACTOR improves clinical outcomes compared to using~     allograft in spinal fusion in the elderly, and thereby find an improved methods operating~     this diffycult patient population.~      The hypothesis is, that there is no difference in clinical outcomes whether you use i-FACTOR~     or allograft i non-instrumentated spinal fusion surgery in patients with spinal stenosis due~     to degenerative listhesis.~   "
51289|NCT02895542|"~     This study to find out more about how patients take their anticancer medications and~     challenges related to taking cancer medications.~   "
51290|NCT02895529|"~     The purpose of this study is to investigate the hypothesis that the efficacy of intravenous~     (IV) itraconazole followed by oral itraconazole is non-inferior to that of intravenous~     caspofungin as empiric therapy for suspected fungal infection participants with fever and~     neutropenia.~   "
51291|NCT02895516|"~     The study is a prospective, open-label, single-arm study, to evaluate the ease of use,~     tolerability, efficacy and safety of the Vibrant Capsule administered in the home~     environment.~      One arm will be assessed: Vibrant Capsule administered twice a week.~      Patients will follow a 2 weeks baseline period and then take the Vibrant Capsule for a~     treatment period of 6 weeks.~      During the 2 weeks of baseline, patients will be asked to refrain from taking any medication~     or supplement to relieve their constipation.~      After 14 days the patients will return and eligibility will be re-assessed. Patients will be~     instructed to complete a simple patient eDiary each day throughout the duration of the study.~     After 3 weeks of treatment, the patient will attend for evaluation and to receive new~     capsules. A final visit will take place at the end of the 6 week treatment period.~   "
51292|NCT02895503|"~     The purpose of this research study is to evaluate the effects of yoga (including breathing~     exercises) on the quality of life in patients, diagnosed and undergoing standard treatments~     for non-small cell lung cancer.~   "
51293|NCT02895490|"~     This randomized clinical trial studies communication training in promoting employment~     retention among cancer patients. Communication training may improve patient-employer~     communication and increase the likelihood that cancer patients will remain employed, reduce~     patients' time away from work, and increase workplace accommodations that enable patients to~     balance treatment and work.~   "
51294|NCT02895477|"~     Goal of this study is to determine the benefit of an improved feature on a new hearing aid~     platform.~      To investigate the improvements of this feature is compared on a new and older hearing aid~     platform. The obtained results will be used for future improvement for this feature. This~     feature should improve the speech understanding and speech recognition of the hearing aid~     user.~   "
51295|NCT02895464|"~     The purpose of the study is to evaluate the feasibility of recruitment procedure,~     intervention including compliance and the collaboration between in- and out patient clinics~     of preoperative home-based exercise in older people before colorectal surgery.~   "
51296|NCT02895451|"~     The purpose of this study is to investigate the effects of an extended behavioral~     intervention in exercise-based CR for improvement of physical capacity, adherence,~     psychological and physiological parameters, compared with usual care.~   "
51553|NCT02892110|"~     Marijuana is the most commonly used illicit drug. There is high demand for effective~     interventions for cannabis use disorder, yet few specific treatments for have been developed.~     This study will evaluate the efficacy of varenicline for reducing marijuana use in people who~     use marijuana frequently.~   "
51297|NCT02895438|"~     Irritable Bowel syndrome (IBS) is a very frequent condition in children. Its management is~     difficult, often resulting in a persistence of chronical abdominal pain.~      In adults, many patients affected by IBS improve under a gluten-free diet, even in the~     absence of Celiac Disease (CD) or wheat allergy. This condition is called Non Coeliac Gluten~     Sensitivity (NCGS). However, it is still not clear how to diagnose and manage NCGS, and the~     pathophysiological mechanisms also remain elusive.~      The aim of this study is to determine if NCGS exists in children with IBS and to identify the~     clinical, serological, and histological characteristics, which could distinguish patients~     with NCGS from conventional IBS and CD patients.~      This is a prospective cohort study in a population of children affected by a moderate to~     severe IBS for more than 6 months. All children had a Gluten Free Diet (GFD) for 6 weeks.~     Then, children who improved under GFD were randomized in two groups for a double-blind~     placebo-controled trial. One group had a reintroduction of gluten followed by a wash-out~     period, then a placebo reintroduction, whereas the other group had the placebo first, then~     the wash-out and the gluten reintroduction.~   "
51298|NCT02895425|"~     The rein registry collects case record data from patients with end stage renal disease~     followed in French Guiana. This allows to generate incidence and rates for terminal renal~     disease, mortality rates for each territory. The regional data are pooled in order to get~     national statistics for end stage renal disease and transplantation activity in order to~     adapt prevention to the main causes of renal failure and treatment and care infrastructure.~   "
51299|NCT02895412|"~     This study is to test a new therapy for patients with acute myeloid leukaemia who are~     undergoing blood stem cell transplant. In this study, the investigators will take a small~     number of your immune cells whose normal function is to give immunity to infections and help~     to fight leukaemia. These cells will be stimulated to multiply in the laboratory and will~     then be given to the transplant recipient after the transplant. This is a sort of immunity~     transplant. The exact purpose of this study is to investigate if these cells are safe and~     effective in patients having a transplant for AML.~   "
51300|NCT02895399|"~     Cervical cancer is the second most frequent cancer of women in French Guiana. Studies have~     shown that populations living in remote villages in the interior of the territory have early~     sexual relations and that multiple sexual partnerships are frequent. Hence, the main~     objective of the study was to determine the prevalence of HPV in these areas, and the~     predictive factors and epidemiology of this viral infection.~      Methods - This multicentric cross sectional study aimed the population of women aged 20 to 65~     years, living in the remote villages along the Maroni and Oyapock rivers. Women wishing to~     participate will be included after being informed of the study team schedule through radio~     address and key opinion leaders. The search for HPV and cytologic examinations will be~     performed for each woman. 2 samples will be taken from each woman: one sample will be sent to~     Fort De France hospital for cytology, and HPV testing; cytologic analyses will be performed~     using the 2001 Bethesda classification. Another sample will be sent to Pasteur Institute in~     Cayenne for sequencing and detection of E6 and E7 RNA which are associated with~     carcinogenesis. HPV infection will be defined by the detection of viral DNA using the~     GREINER-BIO-ONE kit. Statistical analysis of the results will use STATA software and mapping~     will use Mapinfo.~   "
51301|NCT02895386|"~     To evaluate the safety and effectiveness of the ROX Coupler used to create an arteriovenous~     anastomosis in the iliac region (between the iliac artery and vein) in subjects with~     hypertension.~   "
51302|NCT02895373|"~     Bleeding complications and thromboembolic complications are frequent during extracorporeal~     membrane oxygenation (ECMO). Retrospective data suggest that platelet inhibition using~     prostaglandins, in this case PGE1, may reduce thromboembolic complications without increasing~     the bleeding risk. This randomized, double-blind trial aims to investigate the effects of~     PGE1 on bleeding risk, thromboembolic complications and the function of the ECMO.~   "
51303|NCT02895360|"~     Single-agent, open-label, multi-center sequential dose escalation and expansion study of~     BAL101553, administered as an intravenous (IV) infusion over 48 hours to adults with advanced~     or recurrent solid tumors.~   "
51304|NCT02895347|"~     The goal of the project is to define the optimal learning environment and protocol for dvSS®~     simulation activities using medical students as robotic-naïve research participants.~   "
51305|NCT02895334|"~     This study will conduct an initial clinical evaluation of this support program to examine its~     impact on reducing caregiver stress, increasing confidence in daily feeding, and improving~     weight-for-age growth percentiles in infants with Congenital Heart Disease (CHD).~   "
51306|NCT02895321|"~     The chief aim of this study is to evaluate the difference in tooth sensitivity after having~     used a gel containing nano - hydroxyapatite and potassium nitrate~      This randomized double-blind clinical study is designed to compare the efficacy in reducing~     dentin hypersensitivity of a toothpaste gel containing Nano-hydroxyapatite and potassium~     nitrate (Cavex Bite & White ExSense, Cavex Holland BV) with a fluoride-based gel toothpaste (~     Colgate, Protection Caries, Palmolive SPA ).~      Specific objectives :~      To evaluate through standardized tests the dental sensitivity before and after the~     application of toothpastes; To compare the variations of dental sensitivity test and control~     groups.~      Safety:~      determination of adverse reactions, such as increased tooth pain and changes in the oral~     mucosa after application of the materials.~   "
51307|NCT02895308|"~     The aims of this study are to experimentally investigate and compare whether motivation~     variables can predict adherence to a prescribed assignment in face-to-face and online~     interventions using a psychotherapy analogue model.~      A total of 100 participants are included in this study and randomized to either a~     face-to-face or online intervention. Participants in both groups receive a psychoeducation~     session and are given an assignment for the subsequent week.~   "
51308|NCT02895295|"~     The objective of this study is to determine whether providing Medicare beneficiaries with a~     web-based patient-centered decision tool to help them choose among prescription medication~     coverage plans improves outcomes for patients including a greater likelihood of changing a~     plan, better coverage for prescribed drugs, less decisional conflict when choosing plans, and~     greater satisfaction with the choice process relative to current practice.~   "
51309|NCT02895282|"~     The main objective is to investigate chronobiological aspects of childhood obesity studying~     the potential relationship between meal patterns and circadian rhythmicity in a~     cross-sectional sample of obese, overweight and normal weight children/adolescent.~   "
51313|NCT02895230|"~     The research focuses on the safety profile of androgen-deprivation therapy (ADT). The~     hypothesis is that safety issue, as regards to cardiovascular risk, is not homogenous across~     the spectrum of androgen-deprivation therapy modalities. Our study will encompass all ADT~     modalities including intermittent ADT.~      ADT is a cornerstone therapy in prostate cancer management. Decisions about ADT should weigh~     improvements in cancer-specific outcomes against potential increased risks for cardiovascular~     diseases. The potential for harm from ADT should be more precisely defined according to the~     type of ADT. Those potential risks underscore the importance of better understanding benefits~     of ADT, especially in contexts where data are still lacking.ADT is also indicated in sexually~     deviant behavior.~   "
51314|NCT02895217|"~     Exercise training on an immersible ergocycle is becoming more popular as it appears to be~     more suitable for men and women even with poor physical activity level. Commercial tagline~     highlight beneficial effect of this activity on weight management. However there are poor~     information concerning the energy response induced by this activity. The aim of this project~     is to investigate energetic response (energy expenditure and food intake) of a single bout of~     cycling exercise in water vs on dryland in normal weight and overweight premenopausal women.~   "
51315|NCT02895204|"~     To investigate the impact of supplementing fermented Maillard reacted whey protein (F-MRP) on~     natural killer (NK) cell activity, circulating cytokines and serum protein levels.~   "
51316|NCT02895191|"~     Compared with placebo, evaluate the effects and safety of Ulinastatin(UTI) added to~     conventional treatment for ARDS; Evaluate the dose response relationship of Ulinastatin for~     ARDS.~   "
51317|NCT02895178|"~     The purpose of this study is to examine the effects of exercise program on health-related~     physical fitness and biomarkers among breast cancer survivors.~   "
51318|NCT02895165|"~     The PREgnancy and FERtility (PREFER) study is a comprehensive program aiming to optimize care~     and improve knowledge around the topics of fertility preservation and pregnancy issues in~     young breast cancer patients. The program was initiated at the National Institute for Cancer~     Research, IRCCS AOU San Martino - IST in Genova (Liguria Region, Italy) and then it has been~     spread to other Italian Institutions under the umbrella of the Gruppo Italiano Mammella (GIM)~     study group. It is composed of two distinctive studies, one assessing fertility (i.e.~     PREFER-FERTILITY) and the other pregnancy (PREFER-PREGNANCY) issues. Hence, two different~     study protocols were developed under the umbrella of the PREFER registry.~      PREFER-FERTILITY aims to obtain and centralize data about the preferences and choices of~     young cancer patients on the fertility preservation strategies available in Italy.~     Furthermore, it aims to assess the outcomes of patients undergoing one or more strategies for~     fertility preservation in terms of success of the techniques (i.e. recovery of ovarian~     function, number of cryopreserved oocytes, post-treatment pregnancies) and safety (i.e.~     long-term survival outcomes).~      PREFER-PREGNANCY has two main objectives: 1) to obtain and centralize data on the management~     of breast cancer diagnosed during pregnancy, the obstetrical and paediatric care of children~     born after prior in utero exposure to anticancer treatments, and the long-term survival~     outcomes of these patients; 2) to obtain and centralize data on the clinical outcomes of~     breast cancer survivors that achieve a pregnancy after prior diagnosis and treatment of~     breast cancer.~   "
51319|NCT02895152|"~     In patients with Chronic Obstructive Pulmonary Disease (COPD) lifestyles with lower physical~     activity levels have been shown to increase the risk of hospital admissions and shorten~     survival rates. An established process in increasing activity levels is to undergo pulmonary~     rehabilitation classes.~      The investigators wish to identify whether the use of activity monitors,which will provide~     feedback on activity levels, will increase the physical activity levels of patients with COPD~     outside of the supervised pulmonary rehabilitation sessions.~   "
51320|NCT02895139|"~     This study will assess the ability of different orthotic insole treatments to reduce pressure~     under the ball of the foot. This is important for people who have diabetes because their feet~     are at higher risk of foot problems in this area. This study will involve the participants~     wearing a a range of insoles produced by milling, handmade processes and additive manufacture~     along with normal orthotic footwear. A researcher will measure the pressures under the feet~     while the participants walk wearing the orthotic insoles.~   "
51321|NCT02895126|"~     In so-called at risk families, the child-parent attachment relationship is more difficult to~     set up and this can be a barrier to social and emotional development of young children. To~     help parents build and sustain this relationship, and to prevent child development disorders,~     many parenting programs have been created, usually with frequent home visits by early~     childhood professionals. In France, therapeutic interventions at home are little used and~     they are not evaluated.~      In Montpellier, an action of this type has been conducted since 2001 by the Conseil~     Départemental de l'Hérault in collaboration with the University Hospital of Montpellier~     including, in addition to home visits, supervision of professionals: the Appui Parental~     Program.~      Before extending this action to other areas of Herault, the Conseil Départemental de~     l'Hérault, the Abri Languedocien and the University Hospital of Montpellier are conducting~     an assessment to know the effectiveness of the program for families under care.~      This 3-year multicenter prospective study includes 88 children aged 1 to 20 months from~     families meeting vulnerability criteria previously defined, 44 benefiting Appui Parental~     program (experimental group) and 44 benefiting a regular support (control group).~      A paediatric examination on the basis of the Denver scale, parental questionnaires,~     questionnaires to professionals and an a video of infant-parent interactions are used. The~     data, collected at baseline and 18 months later, will be compared.~   "
51352|NCT02894723|"~     Essential Hypertension is characterized by endothelial dysfunction due to reduced nitric~     oxide (NO) bioavailability. Impairment in nitric oxide-mediated vasodilatation in human~     brachial, coronary, and renal arteries has been demonstrated in patients with essential~     hypertension. Administration of L-arginine, a NO substrate yeld controversial results.~      The purpose of the present study, double blind and matched for age, sex and body mass index~     (BMI), is to assess the efficacy of L-arginine treatment on blood pressure (BP) control and~     arterial stiffness in patients with stage1 hypertension.~   "
51630|NCT02891109|"~     The chronic immune thrombopenia is an autoimmune disease caused by B cells. These cells~     produce anti platelets and megakaryocytes antibodies. Some B cells, named regulatory B cells,~     are known to control other cells. Their action in chronic immune thrombopenia is actually~     unknown.~   "
51322|NCT02895113|"~     The pathophysiology of diabetes is multifactorial. Beyond genetic susceptibility loci, a lot~     of acquired risk factors are involved in the development and progression of the disease.~     Chronic complications of diabetes can be divided into vascular and nonvascular. The risk of~     developing complications increases with the duration of hyperglycemia, and usually become~     apparent in the second decade of hyperglycemia. Vascular complications are further subdivided~     into microvascular (retinopathy, nephropathy and neuropathy) and macrovascular (coronary~     artery disease, peripheral arterial disease, cerebrovascular disease). It is estimated that~     the annual decline of estimated glomerular filtration rate (eGFR) in diabetic adults is about~     2.1-2.7 ml/min.~      While there is consolidated evidence about the use of aspirin (ASA) for secondary prevention~     in diabetic patients, there is no consensus on the use in primary prevention; the use of ASA~     in these patients is at physician discretion.~      ASA is an effective antithrombotic agent that inhibits the production of thromboxane (Tx) A2~     and other prostaglandins by blocking cyclooxygenase (COX). In patients treated with aspirin,~     serum TxB₂ level is the most reliable in vivo indicator of COX-1 inhibition than TxA2, due to~     its short half-life and artifacts associated with platelet activation ex vivo.~      COX are present in the kidney in the macula densa, in the medulla and in the interstitium.~     Experimental animals models have demonstrated that COX are involved in regulation of renal~     blood flow. In particular, in a murine animal model, after the administration of COX~     inhibitors such as aspirin and celecoxib, it was observed an improvement in renal plasma flow~     and eGFR, suggesting a role for Tx in the progression of renal damage However, data on the~     relationship between aspirin and renal function in humans are scarce. In a recent work lead~     on a large cohort of 800 patients with non-valvular atrial fibrillation, ASA use was~     associated with a reduced progression of eGFR <45 ml/min during 2 years of follow-up.~     Furthermore, basal levels of urinary excretion of TxB2, correlated inversely with the use of~     aspirin and with the decrease of eGFR at follow-up.~      The aim of the study is to evaluate the decline in renal function in diabetic patients~     treated with low-dose aspirin (100 mg/day) vs. untreated diabetic patients.~   "
51323|NCT02895100|"~     The main objectives of this study are to evaluate the efficacy, safety, and tolerability of~     daily doses of PTG-100 in subjects with moderate to severe ulcerative colitis (UC).~   "
51324|NCT02895087|"~     Despite advances in AntiRetroviral Therapy (ART) leading to a rapid control of the HIV virus~     in individuals affected, HIV can persist indefinitely and there is no cure. The HIV virus has~     been shown to have a unique ability to hide within the human gene inside human cells and in~     tissues, remaining 'silent' and rapidly reactivate 'waking up if ART is stopped.~      There are a number of ways to measure the silent HIV reservoir, including a common~     research-based laboratory test called Cell-Associated UnSpliced (CA-US) HIV RNA. This is an~     early marker of the HIV virus waking up. It is often used to test how well new drugs~     developed to eliminate the silent virus might work.~      This study is examining whether the diurnal variation (daily rhythm) and/or stress can affect~     CA-US HIV RNA levels in individuals diagnosed with HIV and receiving ART.~   "
51325|NCT02895074|"~     To compare the effects of femtosecond laser-assisted cataract surgery (FLACS) and~     conventional phacoemulsification surgery (CPS) on subfoveal choroidal thickness (SFCT) in~     age-related cataracts.~   "
51326|NCT02895061|"~     Primary objective was to evaluate the efficacy between daily and pulse oral alfacalcidol~     treatment of SHPT in chronic hemodialysis patients, a 12-week treatment. Secondary objective~     was to observe the adverse effects between these two treatment regimens.~   "
51327|NCT02895048|"~     The effects of Cardiac Contractility Modulation (CCM) treatment are observed in patients with~     heart failure.~   "
51328|NCT02895035|"~     The objective of this study is to compare the maintenance of intraoperative mydriasis during~     cataract surgery between two drugs: epinephrine, which has routinely been used for decades,~     and Omidria, a newly FDA approved combination drug of phenylephrine and ketorolac. Patients~     undergoing cataract surgery that are enrolled in the trial will randomly receive one of the~     drugs in one eye, and the other eye will receive the drug during the subsequent cataract~     surgery.~   "
51329|NCT02895022|"~     The need to resort to a midwifery course work in cesarean is a common practice. Epidural~     analgesia for labor analgesia is practiced in 90% of women in obstetric work, as when the~     cesarean decision is taken course work in practice and the recommendations are to use the~     epidural catheter in place to convert the epidural analgesia in epidural anesthesia by~     re-injecting a local anesthetic on the catheter. General anesthesia is reserved only cases of~     extreme urgency and cons-indications for regional anesthesia as a purveyor of high maternal~     morbidity and mortality.~      The initial assumption is that the 2% lidocaine with epinephrine is the optimal and~     recommended local anesthetic solution.~   "
51330|NCT02895009|"~     The purpose of the study is to investigate the protective effects of short term TR Band~     compression on transradial coronary occlusion after transradial coronary intervention.~   "
51331|NCT02894996|"~     To predict fluid responsiveness in anesthetized pediatric patient is not an easy task~     although anesthesia provider has to deal with this question on their daily practices. Today,~     very few parameters can help anesthesia provider to predict fluid responsiveness in the~     pediatric anesthetized patient. Therefore anesthesia provider are let with fluid challenge~     with high volume of fluid boluses to see if patient were fluid responsive or not. This could~     lead to fluid overload and it's associated morbidity. We would like to investigate if the~     cardiac output response to a mini fluid challenge of 3 ml/kg in 2 minutes would be predictive~     of the response to an usual fluid challenge of 15 ml/kg in 10 minutes in elective pediatric~     anesthetized patients.~   "
51332|NCT02894983|"~     There is no consensus about the best conservative treatment for patients with dorsally~     displaced distal radius fractures. The previous studies that have examined the most valid~     method for cast immobilization have lacked uniform and patient-rated outcome measures, proper~     randomization and sufficient study population. The aim of this study is to compare functional~     position cast to flexion-ulnar -deviation with dorsally displaced distal radius fractures in~     patients aged 65 years or older. The conservative treatment is performed in clinical practice~     by various health care professionals with different techniques of reduction which are not~     limited to any specific technique in this pragmatic, randomized controlled trial.~   "
51333|NCT02894970|"~     To evaluate feasibility of photoplethysmography (PPG) of pulmonary arteries in adults~     children and neonates and to compare normal controls to premature newborns suffering from~     patent ductus arteriosus and neonates suffering from pulmonary hypertension.~   "
51366|NCT02894541|"~     The purpose of this study is to investigate the effects of food on the~     pharmacokinetics/pharmacodynamics of CKD-519.~   "
51412|NCT02893943|"~     The aim of the study is to evaluate the potential of probiotics on weight management. It is~     hypothesized that the consumption of 1 capsule of probiotics daily will modulate the~     intestinal gut microbiota thereby reducing body weight and fat compared to those who do not~     consume probiotics. In addition, a diet supplemented with probiotics can be expected to be~     more beneficial than a diet without probiotic supplementation in impacting biomarkers of~     obesity-associated disorders including diabetes, hypertension and CVD.~   "
51334|NCT02894957|"~     Rationale: No studies have examined the effect of varenicline for gradual smoking cessation~     in COPD smokers currently not interested in quitting.~      Objective: To compare the efficiency of varenicline-assisted gradual vs. abrupt smoking~     cessation in low-motivated COPD smokers~      Setting: Pulmonary outpatient clinic~      Design: Open, randomized pilot smoking cessation trial~      Participants: COPD smokers with low motivation to quit. Such low motivation will be defined~     as a score of ≤ 3 points observed in a 10 cm visual analog scale (0=non motivated; 10=highly~     motivated).~      Interventions/procedures: Patients will be randomized either to receive varenicline~     (uptitrated to 1 mg twice daily) for smoking reduction or smoke as usual for 4-6 weeks before~     quitting. After quit-day, the two groups will receive standard 12-week varenicline treatment.~     Non-treatment follow-up will continue to 6 months.~      Measurements: The main outcome measure is carbon monoxide-verified complete abstinence rate~     (CAR) 6 months after quit-day. Other measures are: CAR at 3 months; point prevalence at 3 and~     6 months; change in motivation; cigarettes/day; differential dropout rate; decline in~     pulmonary function; COPD symptoms, episodes of exacerbation and medication; and adverse~     events.~      Sample size: One hundred twenty-one subjects per group will be necessary to detect CAR~     differences between the two groups of 15% at 6 months.~      Potential study limitations: The main potential limitation is the lack of 1-yr follow-up.~      Relevance: This study may provide useful preliminary information on the safety and efficiency~     of varenicline for gradual smoking cessation in low-motivated COPD smokers and it may~     assist in the preparation of a larger, more comprehensive trial.~   "
51335|NCT02894944|"~     Pancreatic cancer is associated with an extremely poor prognosis, reflected by a 5-y survival~     probability of less than 5% when all stages are combined. At present, only approximately~     10%-20% of patients are considered candidates for curative resection. The majority of~     patients (50%-60%) are present with metastatic disease, and substantial number of patients~     (approximately 30%-40%) are considered ''locally advanced'' at the time of diagnosis.~      Replication-competent Adenovirus-mediated Double Suicide Gene Therapy~     (Theragene®,Ad5-yCD/mutTKSR39rep-ADP) showed an anti-cancer effect in patients with prostatic~     cancer in phase I study. From the experience of prostatic cancer, the safety of combination~     with standard chemotherapy with Theragene treatment is assessed in this study.~   "
51336|NCT02894931|"~     While previous atherosclerosis-related studies have focused mainly on the atherogenicity of~     lipids, the proposed study aims to investigate the effects of other dietary factors, i.e.~     monosaccharides, disaccharides, amino acids, or artificial sweeteners, on the atherogenicity~     of serum or macrophages. Findings from the current proposed study may shed light on yet~     unknown mechanisms by which the above dietary factors could affect atherosclerosis~     development and CVD risk and hence could possibly assist in the future development of~     anti-atherogenic strategies.~   "
51337|NCT02894918|"~     This study evaluates whether addition of Peginterferon alfa-2a to CHB Patients Treated with~     nucleoside analogues (NAs) can enhance the rate of HBsAg clearance at end of treatment. This~     study is a Randomized, open-label, multi-center study.~      The CHB patients with NAs treatment and have achieved HBV DNA <15 IU/ml、HBeAg <100~     PEIU/ml、HBsAg positive and HBsAg<1500 IU/ml will be randomized into 2 groups:~      Group 1 (Combination group): Maintain NAs treatment while add 48-week standard treatment by~     Peginterferon alfa 2a 180µg/week Group 2 (Mono NA group) : Maintain NAs treatment for 49~     weeks. Note: NAs including: LAM, ADV, ETV, or TDF.~   "
51338|NCT02894905|"~     The purpose of this study is to evaluate the pharmacokinetics (PK) of a single oral dose of~     AL-335 in participants with various degrees of impaired renal function (mild, moderate, and~     severe) compared to participants with normal renal function.~   "
51339|NCT02894892|"~     Gastric cancer is one of the leading causes of cancer-related deaths worldwide. In Taiwan,~     there are around 3800 fresh cases annually, with about 5% of total cancers cases. Gastric~     cancer development is known to follow a multistate process from non-atrophic gastritis,~     atrophic gastritis, intestinal metaplasia, dysplasia, and carcinoma; H. pylori infection~     plays the key role of this carcinogenic process. Although H. pylori eradication would result~     in a marked gastric cancer reduction, treatment success using standard regimens has become~     more difficult in recent years, and increased antibiotic resistance is considered the most~     important reason for decreased treatment efficacy. As no specific new medications have been~     introduced in recent years, novel treatment regimens have been created using different~     combinations, durations and sequences of available medications. The addition of bismuth~     improved the cure rates despite a high prevalence of resistance, and resistance of H. pylori~     to bismuth has not been reported. Bismuth absorption is not required for efficacy in H.~     pylori treatment regimens, suggesting a local mechanism of action. The mechanisms of bismuth~     with responsible for rapid destruction of H. pylori within the stomach remain unclear.~     Knowledge of the mechanism of action of bismuth compounds against H. pylori would be~     beneficial in the development of improved treatment regimens in this era of declining~     eradication success rates. We conduct the pilot study to evaluate the bacteria fragments of~     H. pylori in specimen through electron microscopy after bismuth therapy and provide insight~     into the mechanism of action of pH on bismuth therapy. We also help to develop optimal H.~     pylori therapeutic strategies.~   "
51340|NCT02894879|"~     The purpose of this study is to explore effectiveness of modified chest physical therapy~     techniques using new device in pre and post-operative program in patients undergoing open~     heart surgery~   "
51341|NCT02894866|"~     The purpose of this study is to to evaluate the safety and efficacy of hyperbaric oxygen in~     term gestation newborn infants with hypoxic-ischemic encephalopathy..~   "
51342|NCT02894853|"~     The investigators hypothesize that an early molecular profiling, that includes both tissue~     and blood-bases analysis, for all NSCLC patients, including stage I-III, will increase~     diagnostic efficiency. When molecular profiles are available at an earlier stage of disease,~     more patients will benefit from personalized therapy once needed. This will result in both a~     better quality of life and outcome.~   "
51343|NCT02894840|"~     The study is aim to evaluate the safety and immunogenicity of one dose (15 μg HA per strain~     per dose) of the GPO seasonal trivalent inactivated split virion influenza vaccine (Tri~     Fluvac) in healthy adults aged 18 to 49 years over 90 days post-injection.~   "
52244|NCT02883088|"~     The multicenter observational CLIMA registry has been conceived to explore correlation~     between OCT morphology of atherosclerotic plaques located in the left anterior descending~     artery with mid and long term clinical outcome.~   "
51344|NCT02894827|"~     Polypathology in elderly subjects requires polypharmacy but even though the efficacy of a~     medication and digestive tolerance are ensured, the medication can be taken a long time from~     meals to reduce its side-effects. Despite numerous studies that have investigated links~     between medication and malnutrition, none have assessed the influence of the time the drug is~     taken on the evolution of the nutritional status of elderly hospitalized persons. So as to~     identify the best nutritional criterion in hospitalized persons, a retrospective pilot study~     will be conducted in about thirty patients. Their medication will be recorded and their~     nutritional status will be evaluated using the Geriatric Nutritional Risk Index (GNRI),~     albumin, prealbumin levels, weight and the Mini Nutritional Assessment (MNA) short form.~      This preliminary study will allow us to choose the best nutritional criterion to compare the~     impact of two strategies for taking medication (post prandial versus pre-prandial) on~     improving the nutritional status of malnourished elderly hospitalized patients taking~     multiple drugs.~   "
51345|NCT02894814|"~     The primary purpose of this study is to investigate if patient involvement in the medication~     procedures through elements of the medication system One-Stop Dispensing (use of own~     medication, placed in bedside locker, partly or self-administration of medication) and~     focused dialogue about medication can maintain or improve the patients' health literacy to~     perform the prescribed medical treatment during and after hospitalization.~      The hypothesis is, that involving the patient in the medication procedure and focused~     dialogue about the medicine during hospitalization will improve the patients' health literacy~     measured by patient adherence, patient knowledge and perceptions of safety about the~     medication. It is further expected that more time will be spent together with the patient,~     and that the new medication procedures will be cost-neutral.~   "
51346|NCT02894801|"~     Colorectal cancer (CRC) has high incidence and is associated with high case fatality. In~     France, the 5-year survival, pooled across all cancer stages at diagnosis, ranges from 57% in~     men to 60% in women. About one third of patients diagnosed with CRC will develop a~     metachronous recurrence during the following years. It is of paramount importance to~     accurately identify factors associated with the increased risk of progression and death, in~     order to develop effective follow-up and treatment strategies. However, to accurately assess~     the role of patients' specific characteristics in the progression of cancer several~     methodological challenges need to be overcome.~      One difficulty, common to prognostic studies of cancer, concerns the need to separate the~     effects of prognostic factors on different clinical endpoints, such as disease recurrence vs~     recurrence-free death. Another difficulty, encountered in prognostic studies, is that the~     cause of death is not available or not accurately coded. Yet, some patients are likely to die~     of causes not related to the disease of primary interest, especially in cancers with longer~     survival and in those that affect older subjects. Until recently, the existing statistical~     methodology was not able to simultaneously, deal with both difficulties, i.e. to account for~     (i) possibly different effects of prognostic factors on death vs recurrence, and (ii) unknown~     causes of death. However, this challenge has been addressed by the recent development of the~     Markov relative survival model (MRS) , which extends the Markov multi-state model to~     incorporate relative survival modelling. Simulations demonstrate that MRS is able to~     accurately estimate different effects of prognostic factors on the risk of each of several~     events, including separate effects on disease-specific vs other causes of death. To date, the~     MRS had not been applied in clinical or epidemiological studies.~      The aim of this study was to assess the potential advantages of the new multi-state relative~     survival model (MRS), proposed by Huszti et al. (2012), in a prognostic cancer study. To this~     end, we compared the MRS results with those obtained with two more conventional analyses,~     based on Cox's proportional hazards model, and the multi-state Markov model proposed by~     Alioum and Commenges (2001). The three models were applied to explore the impact of~     prognostic factors on cancer-specific mortality and recurrence, in a large population-based~     French registry of colorectal cancer, with up to 25 years of follow-up.~   "
51347|NCT02894788|"~     Several score systems were created to stratify perioperative risk and predict mortality. The~     study rises from the needing of a rapid and simple system to identify the patient worthy of~     Postoperative Intensive Surveillance. In the first phase Authors retrospectively investigated~     on patients underwent to elective surgery searching for determining factors (DFs) for~     postoperative ICU admission. Later, Researchers prospectively studied how DFs could predict~     the admission in ICU of consecutive patients scheduled for elective surgery during a~     three-months period and created an index, named PoIS (Post-operative Intensive Surveillance),~     based on the results of this analysis. Authors used surgical invasiveness (SI), Diabetes~     Mellitus (DM), Myocardiopathy (MCP), Cerebrovascular Disease (CVD), Body Mass Index (BMI),~     age, serum creatinine level (sCr), Tiffenau Index (TI) and male sex for the development of~     the original model. Authors classified SI from G1 (lowest) to G5 (highest).~      The results show that the power of prediction of postoperative morbidity of PoIS and POSSUM~     resulted coincident and better than the American Society of Anesthesiology scoring system.~   "
51348|NCT02894775|"~     Since the early 1990s, evidence-based medicine has played an increasingly important role in~     decision-making for the treatment of patients with cancer. The highest level of evidence is~     attributed to the results of randomized comparative studies, and the public health~     authorities require proof from randomized therapeutic trials before authorizing the use of~     new treatments. Patients included in therapeutic trials benefit either from the best current~     treatment (control group) or from a treatment supposed to present a better or similar~     efficacy, together with an extremely rigorous surveillance protocol. Inclusion in a~     randomized therapeutic trial represents the optimal therapeutic strategy.In order to optimize~     the fight against cancer, French public health policies have led to the progressive~     implementation of successive nationwide Cancer Plans since 2003. One of the objectives is~     to increase the proportion of patients included in clinical research trials. Thus, the~     fraction enrolled in France has progressively increased but remained low at around 8% in~     2010. The current 2014-2019 plan aims to expand inclusion to 50,000 patients per year. In a~     context of socio-economic inequalities that concern resources, residence and access to~     services, identifying factors that determine inclusion in trials will in turn highlight the~     reasons for non-inclusion.~      The aim of this study was to determine, at a population level, the influence of demographic~     characteristics and socio-economic status of patients with digestive cancer on inclusion in a~     clinical trial.~      Between 2004 and 2010, 4632 patients were recorded by the Burgundy Digestive Cancer Registry.~     According to a balancing score, the 136 patients included in a clinical trial were matched~     with 272 patients who met the eligibility criteria for trials. Deprivation was measured by~     the ecological European deprivation index. A conditional multivariate logistic regression was~     performed.~   "
51349|NCT02894762|"~     This is an interim report for POC testing of skyla Clinical Chemistry Analyzer and four skyla~     Test Systems (ALB, BUN, GLU, and TP). The analyses are performed with skyla Clinical~     Chemistry Analyzer.~      Analyte Principle:~      Albumin (ALB) - Dye-Binding BCG~      Blood urea nitrogen (BUN) - Urease with GLDH (coupled enzyme)~      Glucose (GLU) - Hexokinase, Colorimetry~      Total Protein (TP) - Biuret~   "
51350|NCT02894749|"~     This is a randomized prospective monocentric study to evaluate the benefits of a 3D~     rotational acquisition (3DRA) to assess technical success after treatment of infra-renal~     aneurysm with bifurcated endograft. Patients will be randomized between the standard strategy~     (2D angiography at the end of the procedure and angioCT-scan before discharge) and the new~     strategy (3DRA at the end of the procedure). Expected findings are a reduction of radiation~     exposure and contrast medium used during the hospital stay, with a similar resolution between~     angioCT-scan and 3DRA to depict the main complications after EVAR (occlusion, kinking,~     endoleak). Furthermore, any complication depicted after 3DRA group could benefit from an~     additional procedure during the same operating time, and therefore avoid a second~     intervention for the patient.~   "
51353|NCT02894710|"~     Lidocaine, local anesthetic used for more than five decades, is being intravenously~     administered aiming at managing pain in different types of surgeries with promising results.~     Opioid-induced hyperalgesia need to be considered in ear-nose-throat (ENT) surgery owing to~     the difficulty of locoregional anesthesia and high level of opioid consumption.~      This randomized study aims to compare quality of perioperative analgesia after infusion of~     intravenous lidocaine during carcinological ENT surgery. The main purpose of this study is to~     evaluate morphine consumption during the 48 postoperative hours.~      Others purposes are evaluation of peroperative remifentanil consumption, morphine consumption~     during the 24 postoperative hours, chronic post-surgical pain evaluated from 3 to 6 months~     after carcinologic ENT surgery, and incidence of side effects that can be attributed to~     lidocaine infusion.~   "
51354|NCT02894697|"~     Previous studies reported 20-30% of under-expansion or malapposition with BVS, which would~     increase the risk of adverse events including late stent thrombosis. OCT-guidance may improve~     more optimized scaffold placement and also better outcomes. However, there is still no~     sufficient evidence that OCT has an inevitable role in optimal implantation of BVS and it~     should be more evaluated in real practice. In the study, the investigators will evaluate an~     incidence of OCT-defined BVS sub-optimization requiring additional PCI+A1.~   "
51355|NCT02894684|"~     This study evaluates the role of AZLI in the treatment of acute pulmonary exacerbations of~     CF. For consecutive exacerbations patients will receive AZLI + IV Colistin, or two IV~     anti-pseudomonals.~   "
51356|NCT02894671|"~     The study has as general objective to analyze in the adult population, (male and female) the~     presence of a very common protein, in its normal form and modified, isolated from the blood~     of patients and called albumin. The opportunity to observe the distribution of this protein~     in the population, provides the basis to be able to perform this type of assay also in the~     population of patients with pathologies, in the near future, with the aim of increasing~     knowledge on the subjective tolerability to orthopedic implants.~   "
51357|NCT02894658|"~     The LipiFlow System (TearScience, Morrisville, NC) is an in-office FDA approved treatment for~     meibomian gland dysfunction. It relieves meibomian gland obstruction through the use of heat~     and pulsatile pressure. A recent study has observed that a single treatment with the LipiFlow~     system can decrease dry eye symptoms and objective findings of meibomian gland dysfunction~     for 1 year. We aim to see if the Lipiflow System will be beneficial in patients with~     Parkinsons disease who may have difficulty performing normal meibomian gland dysfunction~     treatment.~   "
51358|NCT02894645|"~     The overall objective of this study is to continue to improve the cure rate of childhood~     acute lymphoblastic leukemia (ALL) in Singapore and Malaysia in the context of a multi-centre~     cooperative trial using a risk-stratified therapy based primarily on early response to~     therapy utilizing a simplified minimal residual disease (MRD-lite) platform.~   "
51359|NCT02894632|"~     A novel magnetic resonance (MR) compatible accelerometer for respiratory motion sensing~     (MARMOT) has been developed as a surrogate of the vendors' pneumatic belts. The aim is to~     model and correct respiratory motion for free-breathing thoracic-abdominal MR imaging and to~     simplify patient installation.~   "
51360|NCT02894619|"~     This observational study evaluates prevalence of functional perinea disorders (stress urinary~     incontinence, overactive bladder syndrome, dysuria, anal incontinence) on CF adults patients~     of the North-West CF Network. Its aims are to measure the severity of urinary and anorectal~     symptoms ; assess their impact on patients' quality of life, sexuality, care and social life~     and relationships ; identify the medical and demographic factors associated with the severity~     of urinary and anorectal disorders and their impact and determine the relationship between~     the severity of these disorders, various repercussions, and risk factors.~   "
51361|NCT02894606|"~     The investigators expect to better characterise B cell subpopulation and functional~     properties early after graft, to analyse effect of induction therapy (thymoglobulin versus~     basiliximab) on B cells, and to compare this B cell profiles with those obtained in our~     previous study in patients with chronic Antibody Mediated Rejection (cAMR)~   "
51362|NCT02894593|"~     The purpose of this study is to evaluate the antiplaque effects of an alcohol-free~     essential-oil containing mouthrinse - Listerine Zero (LZ) and an alcohol-based essential oils~     (EO+) mouthwash compared to a positive control of 0.20% chlorhexidine (CHX) mouthwash, and a~     negative control of a placebo solution (saline), using an in vivo plaque regrowth model of 3~     days.~   "
51363|NCT02894580|"~     The efficacy of implantable cardioverter-defibrillators (ICD) in primary prevention of sudden~     cardiac death (SCD) is well demonstrated but pivotal studies have been published more than 10~     years ago and implantation's conditions tend to change.~   "
51364|NCT02894567|"~     The purpose of this study is to provide proof-of-concept that directional stimulation and~     directional recording, in an intraoperative setting, is perceivable in a subject. The tests~     will be performed using a dedicated intraoperative lead connected to an external~     neuro-recorder/stimulator, during a deep brain stimulation implantation surgery.~   "
51365|NCT02894554|"~     The hepatitis B virus (HBV) infection rate among renal transplant recipients was reported~     from 3% to 20.9%. And patient survival and graft survival rates following renal~     transplantation may be worsen in HBsAg-positive carriers than in HBsAg-negative recipients.~     Due to viral replication in asymptomatic HBV carriers induced by post-transplant~     immunosuppression, liver-related complications, such as liver failure and bleeding, account~     for 37% to 57% of the mortality cases in HBsAg-positive renal allograft recipients.~      Since the late 1990s, Lamivudine has been recognized as an effective and well-tolerated~     antiviral drug for chronic HBV infection. Lamivudine treatment among HBsAg-positive renal~     allograft recipients has significantly improved patient survival rates during short-term~     follow-up. Telbivudine is another approved nucleoside antiviral agent for patients with~     chronic hepatitis B (CHB). Recently, it was shown that eGFR was improved in HBV-related~     decompensated cirrhosis patients after 52 weeks Telbivudine treatments. Additional eGFR~     increase was also observed in Lamivudine experienced CHB patients after switch to Telbivudine~     treatment.~      However, limited results were known about the renal function affected by oral anti-HBV drugs~     when patients received kidney transplantation. Therefore, we would like to conduct this study~     to evaluate the renal function of Lamivudine long term used HBsAg positive patients received~     kidney transplantation after switch to Telbivudine treatment. The clinical and virological~     outcomes will provide valuable insights of clinical practice.~   "
51367|NCT02894528|"~     Fifteen patients were selected, each presenting at least two jaw front teeth indicated for~     extraction: in the Test Group (TG), post-extraction sockets was filled by synthetic bone~     substitute ReproBone, and in the Control Group (CG) the socket was filled only by clot. In~     both groups, the sockets were covered by a resorbable collagen membrane BioMend, which in~     turn was covered by a flap. Computed tomography scans were acquired in the immediate~     postoperative period and 6 months after surgery, and the horizontal and vertical dimensional~     changes in bone crests were quantified.~   "
51368|NCT02894515|"~     The purpose of this study is to investigate whether 2 different tablet compositions are~     similar regarding absorption (uptake) in the body. One composition was used in the clinical~     development program and the other is intended for the market~   "
51369|NCT02894502|"~     The aims of this study will be to evaluate the effect of motivational interviewing (MI) to~     improve self-care in heart failure (HF) patients and caregiver contributions to HF self-care.~     Also this study will evaluate the effect of MI on the following secondary outcomes: In HF~     patients: HF somatic symptom perception, generic and specific quality of life, anxiety and~     depression, sleep quality, mutuality with caregiver, hospitalizations, use of emergency~     services, and mortality; In caregivers: generic quality of life, anxiety and depression,~     mutuality with patient, preparedness, social support and sleep quality.~   "
51370|NCT02894489|"~     Our study is aimed to observe the long termed effect of contact lens wear on ocular surface,~     especially focused on visual function and ocular inflammation mediators.~   "
51371|NCT02894476|"~     The SUBUSQOL cohort aimed to improve knowledge of the quality of ambulatory care, in~     particular the prognostic role of the early satisfaction with care on the change from~     baseline quality of self-reported health status in outpatients with alcohol or opioid~     dependence. It is a multicenter prospective cohort. Satisfaction was assessed using a~     multidimensional self-administered and validated questionnaire during the early care process.~     In addition to measuring satisfaction and obtaining sociodemographic and clinical data, this~     study collected data on the self-reported health status at inclusion and 3, 6 and 12 months~     after inclusion.~   "
51372|NCT02894463|"~     The aim of this study is to evaluate the potential risk of abusive behavior for children in~     care using nitrous oxide for dental care.~   "
51373|NCT02894450|"~     The objective of this study was to investigate whether there is a link between clinical and~     biological variables and bioassay high xaban in elderly patients as part of an unscheduled~     hospitalization.~   "
51374|NCT02894437|"~     The purpose of the Protocol is the prevention of pelvic pressure ulcers within a care network~     of SCI patients whose general organization refers to the medical literature and the~     recommendations of the ministerial circular of 18 June 2004. A conceptual framework for work~     (CFW) will be set up and semi-structured interviews will be conducted with patients and~     professionals. They will confirm or dismiss the CFW gradually with a refined coding As of~     domains and sub-domains of the skin preventing spinal cord injury related to the perceptions~     and behaviors of those involved in the sector. Quality control will be provided by experts in~     qualitative research and interviews will be stopped when the analyzes will further refine the~     domains and subdomains. A final framework will be validated to modulate our organization.~   "
51375|NCT02894424|"~     The idiopathic macular hole, age-related disease, is a major cause of vision loss and affects~     at least two persons in 1000 after 40 years.~      This hole causes an acute decline linked to a central scotoma. The only treatment is~     surgical. The surgery involves removing the posterior hyaloid (vitreous base) to relieve the~     tensile forces. To be sure the removed is complete and to facilitate the closure of the hole,~     a peeling of the internal limiting, the outermost layer of the retina, is often suggested.~     The inner limiting membrane (ILM), transparent and adherent to the retina, is colored with~     vital dyes to facilitate its removal. After closure of the macular hole, the central scotoma~     disappears but a diffuse and asymptomatic loss of pericentral sensitivity is often described.~     This sensitivity decrease could be induced by the dyes used during surgery.~      This effect has not been studied clinically for recent dyes (Membrane Blue Dual®, Brilliant~     Blue®, Acid Violet®) at the concentrations used, but is known in electrophysiology at higher~     concentrations, at least on the isolated retina models.~      It would be interesting to search for a decrease in retinal peri-foveal postoperative~     sensitivity after surgery of macular holes, performed with the usual dyes. Only~     microperimetry can observe this decrease in retinal sensitivity. This is a noninvasive~     technique that explores the macular visual field. It is performed without iris dilatation and~     allows an automatic exploration ensuring rapid and accurate analysis of retinal sensitivity.~   "
51376|NCT02894411|"~     The paralysis of the fourth cranial nerve (paralysis IV), commonly known as the superior~     oblique muscle (SO) paralysis, represents half of vertical strabismus. The diagnosis of SO~     paralysis and of its congenital or acquired etiology, are based on a range of clinical~     findings. The three main clinical diagnostic elements are the hypertropia in paralyzed side~     which increases in adducted position, the positivity of Bielschowsky head tilt test and the~     twisting of the eye fundus. These criteria are always considered together and are~     interdependent. The diagnostic value and the sensitivity of each of these signs is not~     defined. Brain and orbital Magnetic Resonance Imaging (MRI) allowed a better understanding of~     the physiopathology of a number of oculomotor disorders.~      For this reason, MRI constitute a reference for the SO palsy. The atrophy of the SO muscle is~     qualitatively determined by the asymmetry of muscle volume on two contiguous coronal MRI.~      The diagnostic value of various clinical signs observed in SO paralysis (sensitivity,~     specificity) remains unknown.~   "
51377|NCT02894398|"~     The purpose of this study is to evaluate the efficacy and quality of life in women with~     advanced breast cancer (locally advance inoperable or metastatic adenocarcinoma of the~     breast), HR+ / HER2-, who are treated with an aromatase inhibitor or fulvestrant as baseline~     therapy in combination with palbociclib (Ibrance)~   "
51378|NCT02894385|"~     Evaluate the potential effect of hepatic or renal impairment on the pharmacokinetics, safety~     and tolerability of BAY 1841788 (ODM-201).~   "
51379|NCT02894372|"~     The purpose of the study was to assess the effectiveness of Faringomoss in reducing the~     throat discomfort and pain in patients with acute throat diseases and postoperative patients~     after throat surgeries.~   "
54739|NCT02850484|"~     The objective of this pivotal study is to evaluate the relative bioavailability of SYN010 HFA~     Inhaler and Symbicort 160/4.5μg in healthy volunteers with charcoal block.~   "
51380|NCT02894359|"~     Cervical dystonia (CD) is a syndrome characterized by sustained and/or phasic involuntary~     neck muscle activity causing abnormal head postures and movements. It is the most frequent~     form of adult focal dystonia. The distribution of dystonic muscles is unique for each~     patient, explaining the variety of patterns encountered.~      The therapeutic management of CD is essentially local and symptomatic: Botulinum Neurotoxin~     injections and/or specific retraining therapy programmes. Therefore, analyzing the~     characteristics of abnormal head movements and identifying the dystonic muscles are the key~     points of these treatments.~      To a better understanding of the posture and movement disorders of head and neck, we wish to~     establish a three-dimensional (3-D) computer model of cervical spine movements of ten healthy~     subjects built from images obtained with the Cone Beam  system. Then we will compare the~     cervical posture and movements for each of ten CD patients matched in age and genre to the~     computer model. Comparison with patients' images in the axial plane reconstructed by computer~     with the 3-D computer model will lead to the description of various patterns of CD. Analysis~     of the musculoskeletal disturbances in CD should be a help to improve the localization of~     Botulinum Neurotoxin injection sites as well as retraining programmes.~   "
51381|NCT02894346|"~     Since 2014 45 minutes of physical activity (PA) has been a mandatory part of all public~     schools in Denmark. PA has to be part of subject teaching, including Physical Education (PE),~     and of so-called support teaching. Research has shown that teachers not always find it~     meaningful to implement PA during lessons. In addition, even though PA seemingly has positive~     impacts on children's concentration and learning, teachers find it hard to integrate good~     quality PA with the learning objectives of any school subject. The purpose of this study is~     therefore to: 1) Analyse teachers' underlying factors of motivation for using PA as a~     learning tool using The Self Determination Theory (SDT), and 2) analyse how to support~     teachers' motivation by using the theory of scaffolding.~      The study uses mixed methods. Through quantitative and qualitative methods the study analyses~     behavioural patterns focusing on teachers' motivation for implementing PA and need for~     support. The process is iterative moving from a quantitative (survey) to a qualitative~     approach (interviews).~      The study provides new and important knowledge of teachers' motivation for implementing PA as~     a learning tool. Results from SDT analysis will point out teachers' levels of controlled~     versus autonomous motivation, and analysing teacher's need for scaffolding will give insight~     into how teachers' motivation can be framed in the process of implementing PA.~      There can be both potentials and barriers for implementing PA in a learning context, and in~     the process of implementing PA during school days the role of the teacher becomes crucial. It~     is therefore important to understand teachers underlying factors of motivation for using PA~     as a learning tool, and in order to help them carry out qualified and suitable PA, it is~     important that the investigators know how to support them and maintain their motivation in~     this process.~   "
51382|NCT02894333|"~     The ideomotor theory of action control is considered to be central to the understanding of~     human voluntary action. According to the ideomotor theory, an action is represented in terms~     of its desired sensory effects and actions are selected by internally activating these effect~     representations. Recent imagery and behavioral studies showed that this anticipated~     representation of action-effects triggered a sensory attenuation, meaning a decrease of~     perceptive performances or a decrease of sensory event-related potentials (ERP) for an~     expected event. Thus, the sensory attenuation constitutes a relevant behavioral tool to~     investigate sensory anticipation impairment in patients with Parkinson's disease. In a~     behavioral paradigm, patients and matched control participants have to perform a perceptive~     task on predicted visual action-effects mixed with mispredicted visual action effects.~     Performances should be better in mispredicted visual action effects for control participants~     only.~   "
51383|NCT02894320|"~     The ability to predict sensory effects of people's own motor actions is a key component of~     Human action realization. Recent studies revealed this anticipation process to be involved in~     early and late stages of voluntary actions. Nevertheless, the question whether the~     action-effect anticipation is impacted or not by motor pathologies, such as the Parkinson's~     disease, remains unclear. The current study is aimed to clarify this issue by using a~     subliminal priming paradigm in patients with Parkinson's disease and in matched control~     participants. Indeed, subliminal primes corresponding to visual action-effects are displayed~     at different time points before the actions' execution. Results should allow to determine~     whether or not the action-effect prediction is impaired at different stages of voluntary~     action in patients with Parkinson's disease.~   "
51384|NCT02894307|"~     Anticoagulant treatment reduces the incidence of death and cardioembolic events in patients~     with atrial ﬁbrillation or prosthetic heart valve and the incidence of death and recurrences~     in patients with VTE. Warfarin and similar vitamin K antagonists (VKA) have been the standard~     therapy for patients with a metallic valve, or bioprosthesis with atrial fibrillation (AF).~     The Dabigatran versus Warfarin in Patients with Mechanical Heart Valves (RE-ALIGN) trial~     comparing dabigatran etexilate to warfarin was the only randomized controlled study in~     patient with mechanical valve prosthesis, but it was terminated prematurely because of an~     excess of thromboembolic and bleeding events among patients in the dabigatran group. To date,~     novel oral anticoagulants (NOACs) have shown to be not both safe and or effective for~     patients with mechanical valves.~   "
51385|NCT02894294|"~     Seasonal malaria chemoprevention (SMC) is a new strategy recommended by World Health~     Organization in 2012 for areas of highly seasonal transmission such as the Sahel. Although~     randomized controlled trials have shown SMC to be highly effective, evidence and experience~     from routine implementation of SMC has been lacking. For these reasons, we conducted a~     comprehensive evaluation of the coverage, adherence, and impact of SMC on malaria infection~     and disease and anemia when delivered through routine programs using existing community~     health workers in the Kayes region in Mali. Our evaluation used a pre-post design with~     cross-sectional surveys and abstraction of routine health information system data in an~     intervention district (Kita) where SMC was implemented through the health system, and a~     comparison district (Bafoulabe) where SMC was not implemented.~   "
51395|NCT02894164|"~     This is a cohort study in which patients who survive Acute Kidney Injury (AKI) during~     intensive care unit (ICU) admission are recalled at 3-6 months and renal function tests are~     performed.~      The purpose of the study is describe renal function in AKI survivors at follow-up.~      Additional aims are to determine how well admission values of renal function markers perform~     as predictors of renal function at follow-up and whether estimates of renal function at~     follow-up differ depending on which renal function marker is used.~   "
51396|NCT02894151|"~     The primary objective : To compare effectiveness of pain control in endometriosis associated~     pelvic pain between LNG-IUS and DMPA The secondary objective : To compare vaginal bleeding~     pattern, side effect, continuation rate, satisfaction and quality of life between LNG-IUS and~     DMPA in treatment of endometriosis associated pelvic pain~   "
55333|NCT02842723|"~     Prospective, open labelled, phase II, monocenter trial to combine partial surgery resection~     and protontherapy to management paediatric craniopharyngioma.~   "
51386|NCT02894281|"~     Retrobulbar optic neuritis (NORB) is the damage to the optic nerve caused by inflammation. It~     causes a rapidly progressive and painful visual loss, often among young subjects. Diagnosis~     confirmation is important to start proper treatment, because a NORB is often the first~     symptom of multiple sclerosis. This diagnosis, based on a set of arguments, is difficult to~     define by a non-expert ophthalmologist.~      The pupillary light reflex is a way to test the visual afferent pathways. If it is subject to~     a large inter-individual variability, the dynamics of the pupillary light reflex and its~     latency are more reproducible. An easy way to study the dynamics of the pupillary light~     reflex is to study the pupillary cycle time (PCT). In the case of NORB, elongation of the~     conduction in the visual afferent pathways related to demyelination plate increases the~     latency of the pupillary light reflex and decreases the frequency of the PCT.~      Our hypothesis is that PCT dynamics measures would be a reliable indicator and easy to~     evaluate some pathologies affecting the integrity of the nerve. The validation of a decrease~     in the frequency of the PCT in NORB, compared to the frequency observed in subjects~     ophthalmological or neurological disease, could help developing methods to study the~     conduction of the visual pathways with portable devices used during the standard~     ophthalmologic consultation and quickly orientate patients to specialized centers.~   "
51387|NCT02894268|"~     Doxycycline- and Furazolidone-containing Quadruple Regimen can be a successful rescue~     treatment for Helicobacter pylori Infection patients after Failure of several therapy. It is~     superior of tailored therapy as rescue treatment for helicobacter pylori Infection after~     failure of several therapy.~   "
51388|NCT02894255|"~     This prospective multicenter registry evaluates the efficacy of hybrid coronary~     revascularization (HCR) combining coronary artery bypass surgery (CABG) and percutaneous~     coronary intervention (PCI) in the treatment of multivessel coronary artery disease. CABG is~     to be performed in the left anterior descending artery and the left circumflex artery using~     only arterial grafts, whereas PCI is to be conducted for the treatment of significant~     stenotic disease in the right coronary artery with everolimus-eluting stents (EESs). This~     research plans to involve patients scheduled for coronary revascularization for multivessel~     coronary artery disease who consent to participate in the registry.~   "
51389|NCT02894242|"~     This investigation is designed to evaluate the performance as well as the patients overall~     acceptance of the mask.~   "
51390|NCT02894229|"~     The primary purpose of the present study is to investigate the relationship between~     mindfulness and stress habituation. The investigators propose to measure the effect of~     mindfulness on stress habituation by randomly assigning participants to a 6-week~     mindfulness-based stress reduction group intervention, a cognitive-behavioral skills group~     comparison intervention, or a waitlist control condition followed by repeated acute~     psychosocial stress testing (2 laboratory sessions on 2 separate days). Saliva will be~     collected from participants throughout both laboratory testing sessions to measure HPA axis~     activation (an essential stress-responsive system), along with other measures of~     physiological and psychological stress (e.g., heart rate, blood pressure, emotions).~     Mediators and moderators of treatment outcome will be examined. The cognitive-behavioral~     skills group condition is an appropriate comparison group due to the well-documented efficacy~     of cognitive-behavioral interventions on stress.~   "
51391|NCT02894216|"~     The investigators retrospectively reviewed all radionuclide shuntographic tests using~     (99m)technetium-pertechnetate (DTPA) performed between August 2005 and December 2015 in~     nuclear medicine department of Far Eastern Memorial Hospital. The results of shuntography~     were evaluated visually and qualitatively, and correlated with clinical follow-up. The tests~     were interpreted as normal and abnormal, including complete distal obstruction, partial~     distal obstruction or miscellaneous. Clinical outcomes within 30 days were defined based on~     subsequent need for revision, re-implantation or adjustment of shunt pressure. Then the~     investigators calculated the sensitivity (Se), specificity (Sp), positive predictive value~     (PPV), negative predictive value (NPV) and overall accuracy.~   "
51392|NCT02894203|"~     The investigators aim to explore the psychobiological effects of a 5-day meditation~     intervention on offenders within dangerous and severe personality disorders (DSPD) unit at~     HMP Whitemoor. DSPD unit accommodates offenders with psychopathy or with two or more~     personality disorders. DPSD unit provides them with a 5-year rehabilitation programme that~     consists of group and individual therapy and aims to improve their self-regulation.~      This project includes a total of 60 participants and has two major methodological~     innovations. First, it will include yoga as an active control group that will be matched to~     the meditation intervention (which means it will have the same length and the same social~     components) and a passive control group that will be following their usual regimen. Thus, the~     effects of meditation will be contrasted with another type of intervention and with not~     receiving any intervention.~      The second methodological innovation is the combination of psychological and biological~     measures. Psychological measures include questionnaires (emotion regulation, mindfulness,~     stress) and cognitive measures (attention,empathy,behavioural control). Biological measures~     include EEG to measure brain activity related to empathy; gene expression and protein~     interlukin-6 to measure changes in immune system; and stress related hormone cortisol. The~     investigators also aim to determine to whom does meditation benefit the most by exploring how~     initial expectations of meditation, personality, mood and previous life adversity predict~     outcomes of meditation or yoga. The data will be collected at three time points: at baseline,~     immediately after and 10 weeks after the 5-day intervention.~      The investigators expect that meditation and yoga will similarly improve mental and physical~     health. If this hypothesis are confirmed, these results will extend previous findings on the~     benefits of meditation and yoga to vulnerable populations, and would provide a cost-effective~     addition to prisoner rehabilitation.~   "
51393|NCT02894190|"~     The main aim of this study is the development of the Beliefs about Ventilation Questionnaire~     (BVQ).~   "
51394|NCT02894177|"~     Difficult weaning from ventilation and extubation failure are major issues in intensive care,~     concerning 30% and 12% of patients respectively. These can be partly explained by the lack of~     accuracy of spontaneous breathing trial (SBT) failure criteria to predict extubation failure.~     The investigators performed a pilot study to evaluate transcutaneous carbon dioxide pressure~     (tcPCO2) monitoring during SBTs. The results showed that the difference between maximum and~     initial tcPCO2 (or ΔtcPCO2) was significantly higher in the group of patients who failed SBTs~     according to the usual criteria. Moreover, the results suggested that ΔtcPCO2 could be an~     accurate and early criterion for SBT failure. The size of the study could not examine ΔtcPCO2~     regarding extubation failure. Therefore, the main objective of this study is to determine if~     Δ tcPCO2 during SBTs is associated with extubation failure.~   "
51397|NCT02894138|"~     In this study the investigators test the hypothesis that alteplase given intra coronary after~     PCI reduce infarct size in patients with ST-elevation myocardial infarction(STEMI) and~     impaired microvascular function defined as a value of index of microvascular resistance (IMR)~     >30.~   "
55732|NCT02837510|"~     This study will examine how abstinence-induced brain changes contribute to smoking cessation~     outcomes in treatment-seeking smokers.~   "
51398|NCT02894125|"~     Low back pain is considered to be chronic if it has been present for longer than three~     months.~      This pathology is extremely frequent with an annual incidence between 5 in 10 % of the~     general population. Thus she is frequently met in general medicine, in particular to the~     ageing subject. It is the 2nd motive for consultation.~      The Chronic Low Back Pain is a mild pathology the forecast of which is in the favorable great~     majority of the cases but she pulled a socioeconomic cost mattering with a poly-consumption~     of care, in private individuals.~      The primary objective of this study is to determine the impact of a 3 months SPA Therapy on~     the Chronic Low Back Pain in older adults (from 60 to 80 years old) realizing a SPA Therapy~     of 3 weeks to Neyrac-les-Bains.~   "
51399|NCT02894112|"~     Epidemiological studies indicate that risk of type 2 diabetes is lower when milk is consumed~     in the regular diet. Milk products are unique in that they produce high insulin response~     despite their low glycemic index. The general aim of the proposed study is to determine the~     effect of fluid milk on attenuating the postprandial surge in plasma glucose and triglyceride~     after meals and its associated physiological mechanisms. The investigators hypothesize that~     the consumption of one or two servings of non-fat milk added to a standard oral glucose~     tolerance test (OGTT) solution or the high fat tolerance test meal will attenuate~     postprandial hyperglycemia and triglyceridemia. The investigators hypothesize that the~     postulated improvement in postprandial metabolic response due to the consumption of fluid~     milk will be associated with increased postprandial insulin secretion as well as~     insulin-mediated endothelial vasodilation and whole-limb perfusion.~   "
51400|NCT02894099|"~     In adults, the sedentary behavior was related to cardiovascular risk markers, regardless of~     the level of physical activity (PA). However, the interruption of prolonged sedentary time~     has shown positive results even when performed in breaks of low intensity and short duration~     of activity. The aim of this study is to analyze the influence of a sedentary uninterrupted~     period, as well as different forms of breaks in sedentary time for the glycemic, insulin and~     inflammatory markers responses in older adults. This is a controlled clinical trial to be~     conducted in older (≥ 65 years) and sedentary (<150 min / week of moderate to vigorous~     physical activity) people. Those with BMI ≥ to 35.00 kg /m2; diabetic, on medication for~     glycemic control, or with absolute or relative contraindications to PA practice will not be~     included . Participants will undergo four phases of intervention separated by an interval of~     7 days: (1) Prolonged Sitting Time(PST), in which older people will stay for 5 hours seated;~     (2) Prolonged sitting with PA of light intensity and short duration (LiSd), time sitting is~     interrupted for PA bouts of 50-60% of the Heart Rate (HR)max; (3) Prolonged sitting with PA~     of moderate intensity and short duration (MiSd), time sitting will be interrupted for PA~     bouts of 65-75% predicted HR max; (4) Prolonged sitting with PA of moderate intensity and~     long duration (MiLd,) time sitting will be interrupted with PA bouts of 65-75% of HRmax. PA~     bouts will be performed by walking into a hallway every 20 minutes of sitting time and will~     last 2 minutes, except in MiLd phase (10 minute breaks every 75 minutes). To evaluate the~     effects of different PA interruptions in plasma glucose, serum insulin and inflammatory~     markers, blood samples will be collected serially (-30min, Baseline and 30min, 1h, 2h, 3h, 4h~     and 5h after a standardized meal. It is expect that interruption of sedentary time, even with~     breaks of short duration and light intensity can bring benefits to cardiovascular risk~     markers even in the elderly.~   "
51401|NCT02894086|"~     Acute appendicitis is a frequent surgical emergency, with an estimated incidence of about~     80,000 cases a year (in France). It mainly affects young adults but is associated with a low~     complication rate and a short stay in hospital. Ambulatory treatment is an innovative type of~     care in which the patient is hospitalized for less than 12 hours and does not stay overnight~     in hospital.~      Ambulatory care is based on the guidelines issued by three French learned societies (the~     SFCD, the ACHBT and the AFCA) and has been defined by the French government as a national~     priority.~      The literature data show that 20% of patients undergoing appendicectomy for acute~     appendicitis can be treated on an ambulatory basis. However, the success factors for~     short-stay care (hospitalization <24 hours) or ambulatory care (hospitalization <12 hours)~     have yet to be identified.~      The investigators thus intend to perform a retrospective study of data from the PMSI French~     national hospital information system, in order to identify factors that are predictive of a~     length of hospital stay below 24 hours in patients having undergone appendicectomy for acute~     appendicitis during 2013 in France. The objective is to define the population of patients~     that could potentially benefit from ambulatory care.~   "
51402|NCT02894073|"~     Placement of a peripheral venous catheter (PVC) is the most common invasive procedure in~     anaesthesia and perhaps even in the field of medicine as a whole. This procedure may be~     challenging in the obese patient - even for the most experienced healthcare professionals.~      In a study, PVC placement was considered to be difficult in 46% of obese patients but only~     13% of non-obese patients.~      Placement of a central venous catheter is an option when PVC placement is impossible,~     although central access is associated with a non-negligible risk of complications~     (pneumothorax, infection, arterial puncture, etc.).~      Facilitating peripheral venous access in obese patients should shorten the time required for~     PVC placement, decrease the number of perfusion attempts (a source of dissatisfaction and~     discomfort for the patients) and limit the use of a central venous catheter.~      Although a number of novel vein visualisation devices (such as the VeinViewer®Vision from~     Christie Medical) have been developed to guide PVC placement, there are no literature data on~     the value of these devices in the management of difficult venous access in obese patients.~   "
51403|NCT02894060|"~     Cardiovascular disease linked to atherosclerosis (e.g. infarcts, cerebro-vascular accidents)~     are one of the main causes of mortality in the general population. The recruitment of~     macrophages from the walls of the arterial lumen followed by unregulated capture of oxidated~     LDL (LDLox) leads to the accumulation of cholesterol esters and the formation of foamy cells~     characteristic of fatty streaks, the first phase of atherogenesis. These fatty streaks are~     rarely followed by clinical events, but can progress to complicated atheromatoses~     (calcification, rupture) resulting in the occurrence of various clinical events such as~     myocardial infarction and cerebro-vascular accidents (CVA). Once oxidated, LDL becomes~     immunogenic and induces anti-LDLox antibody production that could be markers of progression~     of atherosclerosis. During LDL oxidation, a multitude of specific oxidative epitopes (SOE)~     such as oxidated phospholipids (PLox) and malondialdehyde-lysine epitopes (MDA) are~     generated. In order to measure the level of markers in the blood, researchers developed a~     series of immunologic levels in vitro, using specific antibodies directed against~     well-defined epitopes. Recently, it was shown that Lp(a ) would be the preferred transporter~     of these PLox. In fact, several clinical studies show a strong correlation between PLox/apoB~     concentrations and Lp(a). This marker (PLox/apoB) predicts future morbidity and mortality due~     to cardiovascular diseases, including CVA, up to 15 years in advance, independent of all~     other known risk factors. CD36 is a scavenger receptor that recognizes LDLox, but more~     specifically PLox present in these lipoproteins .One soluble form of inflammatory CD36~     (sCD36) was recently identified. In this study, only healthy volunteers were recruited in~     order to be able to establish normal serum ranges of different immunologic biomarkers.~   "
51404|NCT02894047|"~     Rheumatoid arthritis (RA) is the most frequent form of chronic inflammatory rheumatism in~     adults. The erosive damage influences the functional prognosis in patients with RA. At~     present, there are no sufficiently sensitive and specific predictive markers of erosive~     damage.~   "
58246|NCT02804490|"~     The purpose of this randomized control trial is to test the impact of provitamin A carotenoid~     biofortified maize meal consumption on maternal and infant vitamin A status.~   "
51405|NCT02894034|"~     Sub Arachnoid Hemorrhage (SAH) is a public health concern because of its high incidence~     (7/100 000 inhab.), its mortality rate (25%), and its morbidity rate (50%).~      Prognostic tools are indispensable in guiding and optimizing the care of these patients.~      Some diagnostic factors have been identified (e.g. age, comorbidities, ACSOS , GCS, ICP,~     occurrence of complications) as well as some classification schemes used for grading~     seriousness of the disease (Hunt and Hess, World Federation of NeuroSurgery).~      A tool that is simple, reliable, reproducible, non costly, non invasive, and simple to~     perform (including remote methods and without changing planned patient care) would be ideal.~      The measurement of the Optic Nerve Sheath Diameter (ONSD,) correlated by MRI and ultrasound~     in previous studies, with intra-cranial pressure (ICP: a fundamental prognostic factor for~     SAH) could be one of these tools.~      This measurement, previously demonstrated using ultrasound, could be carried out at the time~     of the patient's initial cerebral scan.~      In practice, at admission each patient undergoes a cerebral CT scan much more often than an~     ultrasound (faster, less costly, less technical training required).~      Two preliminary studies seem to suggest that this measurement of ONSD on CTc is a predictive~     factor for morbi-morbidity in patients having serious traumatic skull fractures.The~     measurement is reliable, reproducible, non invasive, and non costly, with good sensitivity~     and specificity.~      Proving that it is also applicable to SAH could be particularly useful.~   "
51406|NCT02894021|"~     Lymphoceles, or seromas, are the most frequent complication following mastectomy and are~     associated or not with axillary dissection occurring in 10 to 90% of cases. It is defined as~     the presence of a palpable post operative serous accumulation that is bothersome for the~     patient and requires a puncture and drainage or even several repeated punctures. The presence~     of seromas is therefore associated with discomfort and pain. Seromas could also be~     responsible for increased morbidity due to complications such as infection, suture~     separating, lymphedema, prolonged of hospital stay, or a delay in initiation of adjunct~     treatment (e.g. chemotherapy, radiotherapy). Some risk factors have been identified, such as~     obesity, increased post operative drainage of J1 to J3, and arterial hypertension.~      Different measures have demonstrated the benefits of limiting axillary lymphoceles after~     dissection : placement of a drain, padding and delay in shoulder mobility.~      Studies have shown that axillary padding decreases lymphocele development and shortens the~     length of hospital stay. Some studies based on padding of the mastectomy site also have shown~     a decrease in post operative seromas; however no study has been done on the usefulness of~     padding in the mastectomy site alone because they include both padding and a drain or padding~     of the axillary area.~      The padding technique the investigators employ is performed at the donor site in breast~     reconstruction by latissimus dorsi muscle flap, demonstrating a reduction in the rate of~     seromas.~      In this study, the classic technique will be compared to padding in the mastectomy site with~     short drainage (48h).~   "
51407|NCT02894008|"~     This is a study to assess the safety of a new candidate Leishmania vaccine ChAd63-KH in~     patients with persistent post kala azar dermal leishmaniasis (PKDL).~      This is a Phase II trial in patients with PKDL, to assess the safety and compare the humoral~     and cellular immune responses generated by the candidate vaccine in patients, and observe any~     clinical changes in the disease over a 42 day period following vaccination.~      Study design: Eight adult volunteers will receive 1x10(10)vp and the subsequent eight~     volunteers will receive 7.5 x10(10)vp. Adolescents will be vaccinated with either 1x10(10)vp~     or 7.5 x10(10)vp, to be determined by evaluation of all available data after DSMB & CTSC~     review.~   "
51408|NCT02893995|"~     This is an open-label, multicenter, parallel, randomized (1:1 Slow Dose Titration Group;~     Rapid Dose Titration Group), two-group study to evaluate the safety, tolerability,~     pharmacokinetics and efficacy of slow and rapid dose titration regimens of subcutaneous~     Remodulin infusion in subjects with pulmonary arterial hypertension (PAH). The study will~     include about 50 subjects at up to 10 clinical trial centers in China. The treatment phase of~     the study will last approximately 16 weeks. Subjects who complete all required assessments~     will also be eligible to enter a long-term open-label, extension study (CVT-CV-004).~   "
51409|NCT02893982|"~     The objectives of this study are to demonstrate feasibility of an optimized, image-guided~     pre-planned workflow to deliver at least 25 Gy to the periphery of the target lesion while~     maintaining established dose constraints to normal tissues, and to determine the maximum~     tolerated dose (MTD) while evaluating treatment delivery, safety, and efficacy utilizing a~     pre-planned and optimized image-guided workflow for percutaneous HDR brachytherapy of liver~     lesions.~   "
51410|NCT02893969|"~     The goal of this study is to investigate when is the best time to resume physical activity~     following a head injury. Two treatment plans will be studied; the first treatment plan~     consists of gradually reintroducing physical activity in the child's routine, starting 72~     hours following the head injury. The second treatment plan involves physical and mental rest~     until the child as no more symptoms. Once symptom free, physical activity is gradually~     reintroduced in the child's routine.~   "
51411|NCT02893956|"~     Experimental nociceptive stimulation of the fetus and neonate induces pulmonary artery~     vasoconstriction. The investigators assessed whether echocardiography for Ductus arteriosus~     screening may generate this hemodynamic response and whether postural support would be able~     to modulate it.~      Study design~      Prospective, single center, randomized study in less than 29 weeks of gestation neonates,~     with a post natal age < 48 hours, and requiring invasive mechanical ventilation.~      Crossover design with order of echocardiographies determined by computer randomization: in~     one group ultrasounds are performed with postural support, than standard conditions, in the~     other, ultrasounds are performed in standard conditions than with postural support.~      The objective of the study is to assess the ratio of the acceleration time/ejection time of~     pulmonary arterial flow.~      The others objectives are to assess echocardiographic-Doppler features (ductus arteriosus~     shunt pattern, pulmonary flow pattern, estimated systolic pulmonary arterial pressure, right~     and left ventricular functions using tissue Doppler imaging and speckle-tracking~     echocardiography), pain assessment with a clinical scale and heart rate variability analysis.~   "
51413|NCT02893930|"~     This phase II trial studies how well sapanisertib works in treating patients with pancreatic~     neuroendocrine tumor that has spread to other places in the body, does not respond to~     treatment, or cannot be surgically removed. Drugs such as sapanisertib may stop the growth or~     shrink tumor cells by blocking some of the enzymes needed for cell growth.~   "
51415|NCT02893904|"~     A cerebral pharmacodynamic feedback may help the anesthesiologist to adjust anesthetics~     administration. The BIS, which provides a single number resulting from an algorithm~     calculated from cortical EEG parameters, may play this role.Moreover, halogenated agents and~     propofol may have different EEG effects, which might interfere on measured BIS values.~      The aim of this prospective randomized study was to compare, in steady state conditions, the~     EEG profiles in children anesthetized with sevoflurane (S) or propofol (P) : for both~     anesthetics, the BIS-concentration relationship and raw EEG were analysed at different levels~     of general anesthesia.~   "
51416|NCT02893891|"~     Literature data clearly demonstrate that treatment of obese patients is very expensive, long~     and achieve weight loss may not be permanent, and regardless of whether the treatment~     dominated diet therapy, physical activity, or pharmacotherapy. Experience of the last decade~     has shown that after surgical interventional treatment of obesity occurs not only long-term~     (10 years and over) weight loss of 35-40%, but also an important endocrine changes.~      In recent years, it was discovered a number of signaling molecules produced by adipose~     tissue, whose physiological significance beyond the general metabolic aspects organism. The~     fat is therefore currently understood as an endocrine organ whose hormones modulate the~     function of many systems, including the skeleton. These hormones include the adipokines that~     modulate metabolism skeleton as at tissue level (Leptin, Adiponectin) and indirectly - by~     activation of neurohumoral hypothalamic centers - Leptin.~      Studying endocrine interactions between adipose tissue and bone is a highly topical issue.~     This mutual communication is a homeostatic feedback system in which adipokines and molecules~     secreted by osteoblasts and osteoclasts are the connecting link active axes fat - bone~     tissue. However, the mechanisms of this axis remain largely unknown.~   "
51417|NCT02893878|"~     The purpose of this 2016/17 pilot study is to improve the combination of a card-based adverse~     drug reaction (ADR) system and the use of routine data to collect adverse events following~     vaccination with seasonal influenza vaccines, as per European Medicines Agency (EMA) guidance~     and Pharmacovigilance Risk Assessment Committee of EMA (PRAC) requirements, and to identify~     additional data which may need to be collected in order to appropriately address the~     requirement.~   "
51418|NCT02893865|"~     Published data indicate that obstructive sleep apnea syndrome (OSAS) worse the prognosis of~     coronary artery disease (CAD) and that oxidative stress can link this 2 diseases.~      Investigators hypothesise that oxidative stress decrease after 3 months of continuous~     positive airway pressure (CPAP) in this specific population.~      The results may have major implication in the comprehension of physiopathologic processes~     linking OSAS and CAD and in the treatment of OSAS in this specific population.~   "
51419|NCT02893852|"~     The purpose of this study is to investigate the effects of the Cognitive Orientation to daily~     daily Occupational Performance Approach (CO-OP Approach) on activity and participation in~     school-aged children with developmental coordination disorder (DCD).~   "
51420|NCT02893839|"~     Patients consulting in the Allergy Unit of the Arnaud de Villeneuve Hospital for whatever~     suspicion of allergy were asked to participate in the study. Besides a standard battery of~     respiratory allergens, native raw and cooked potato were tested by means of the prick to~     prick method, using a metal lancet.~   "
51421|NCT02893826|"~     Safety and Pharmacokinetic study comparing intracisternal EG-1962 to enternal nimopidine in~     the treatment of aneurysmal subarachnoid hemorrhage.~   "
51422|NCT02893813|"~     Ectropion of the eyelid can lead to skin retraction, stenosis of lacrimal point, chronic~     watering, visual discomfort or low visual acuity, mostly when it occurs with ectropion of~     lacrimal point. The objective of the study is to compare two surgical strategies for eyelid~     ectropion combined with ectropion of the lacrimal point~   "
51423|NCT02893800|"~     The project aims to make new technologies for locating people with dementia easier to use for~     the patients and those caring for them.~      Objective: To systematically understand what improves the user experience of persons with~     dementia (PwD) and their primary caregivers (CG) with locating system watches to ultimately~     allow users to obtain more benefits from using these watches.~      Aim: Improving the user experience of PwD and CG with locating system watches using a~     cross-over design and a theory-based educational session approach.~   "
51424|NCT02893787|"~     The main goal of this study is to compare the values of echocardiographic parameters obtained~     by Speckle Traking analysis on myocardial function among patients under 18 years treated with~     anthracyclines in childhood, with healthy age and sex mached volunteers.~   "
51425|NCT02893774|"~     Generally, French studies concerned with the quality of life of cancer patients focus on the~     period of treatment (up to 2 years post diagnosis). However, studies about quality of life~     after cancer are relatively rare (= long-term quality of life, or from 5 years post~     diagnosis). These studies mainly concern the most common cancers (breast and prostate).~      Or changes in quality of life after treatment could be different depending on the type of~     cancer. In addition, there is a significant influence of sociodemographic variables on the~     quality of life in remission.~      Similarly using remote diagnostics, quality of life questionnaires related to health, must be~     reassessed because too often developed for situations in process.~      Based on these findings, ELCCA II study proposes to study for five years, the evolution of~     the impacts of two types of cancer (breast and melanoma) on quality of life (overall and~     related to the subjective health), socioeconomic status, and behavioral and emotional~     dimensions (post-traumatic development, coping, anxiety-depression) of those treated.~   "
51426|NCT02893761|"~     A database of breast cancer patients was established at Institute Bergonié since the 90s , to~     assess patients' survival, assess practice, search for prognostic factors.~   "
51427|NCT02893748|"~     The purpose of this study is to compare the level of cleanliness using the HyGIeaCare Prep vs~     the standard of care Split-dose PEG prep used prior to colonoscopy.~   "
51450|NCT02893449|"~     Main objective:~      To assess the impact of a structured program of preoperative cognitive remediation on~     postoperative social adaptation in patients suffering from Parkinson's disease profiting from~     bilateral subthalamic nucleus stimulation.~      Secondary objectives:~      To assess in the same patients the impact of structured program of preoperative cognitive~     remediation on quality of life, mood, anxiety, apathy and psychologic, social and~     professional functioning depending on psychiatric symptomatology after intervention.~   "
60870|NCT02770131|"~     Review of clinical characteristics of patients who are prescribed Repatha® and how their~     treatment is managed.~   "
51428|NCT02893735|"~     The aim of this study was to evaluate the clinical performances of nano-hybrid resin~     composite systems used for anterior diastema closure and tooth reshaping at 4 years in~     service using FDI Criteria.~      Twenty-three patients with diastema problem were enrolled. Nano-hybrid resin composites to be~     used on each patient were randomly selected. Thirty-seven teeth (10 patients) were restored~     with Filtek-Z550 (3M/ESPE) in combination with Adper™ Single Bond 2 (3M/ESPE) in Group 1;~     whereas 39 teeth (13 patients) were restored with Charisma-Diamond (Heraeus Kulzer) in~     combination with Gluma2 Bond (Heraeus Kulzer) in Group 2, by two operators. Esthetic,~     functional and biological properties of the restorations were evaluated at baseline, 1-4~     years using FDI Criteria establishing a score-range of 1-5. The data were evaluated using the~     Fisher's Chi-Square (p=0.05).~   "
51429|NCT02893722|"~     This study intends to carry out a prospective, randomized, double blind and controlled study~     to compare the influence of Atosiban and placebo on uterine contraction frequency,~     endometrial blood flow perfusion, oxytocin and serum concentration of PGF2α, embryo~     implantation rate and clinical pregnancy rate on the RIF population after fresh embryo~     transfer, so as to further clarify the curative effect of Atosiban in the treatment of RIF~     and provide evidence-based basis for Atosiban for application in RIF population.~   "
51430|NCT02893709|"~     The objectives of this study are to examine the effects of ethnicity, gender, and proton pump~     inhibitor (PPI, omeprazole), on the human gut microbiome. The investigators hypothesize that~     PPI therapy might perturb microbial communities and alter the gut microbiome. Young, healthy~     subjects of Chinese, Malay and Indian ancestry, were enrolled. They were required to provide~     a baseline stool sample (Day 1) and were then given a course of omeprazole at therapeutic~     dose (20 mg daily) for a duration of 7 days. Stool samples were collected again on Day 7 and~     Day 14 (one week after stopping omeprazole). The DNA samples were subjected to 16S ribosomal~     ribonucleic acid (rRNA) sequencing.~   "
51431|NCT02893696|"~     After injection of the spinal anesthetic drug, women will be allowed to lie down immediately~     (0-30 sec) or after three minutes (180 sec) of sitting. The incidence of maternal hypotension~     and fetal umbilical cord blood pH will be recorded.~   "
51432|NCT02893683|"~     Cognitive impairment affects up to 65% of multiple sclerosis (MS) subjects, especially memory~     function.~      Rothschild Foundation has developped the Paris Visual Learning and memory Test (PVLT). 165~     healthy volunteers were studied for its normalization.~      The main objective of the present study is to assess the validity of PVLT by comparing MS~     patients' test results to a database including the test results of 280 healthy control~     subjects, following recommended international standards.~   "
51433|NCT02893670|"~     Background: Smooth transition of adolescent patients diagnosed with inflammatory bowel~     diseases (IBD) to adult care is necessary in order to secure continues clinical management~     and to prevent possible deleterious clinical and psychosocial implications. In recent years~     there is an emphasis on successful transition, however, there are no standardized models or~     consensus guidelines incorporating both clinical and psychosocial aspects of transition.~     Objectives: To examine the effect a comprehensive clinical and psychosocial transition~     package on clinical management and patients outcomes in adolescents with IBD. Design: A~     prospective, trans-sectional study. Setting: The Schneider Children's Medical Center and the~     Rabin Medical Center. Participants: Children 17 year to 18 years who are diagnosed with IBD~     and are planned to initiate transition process to adult care. Main outcome measures: Change~     in clinical management as a result of tailored re-evaluation as a part of tailored transition~     package. Secondary outcome measures: a. The effect of a tailored transition package on~     patients' self-efficacy perception and readiness for transition. b. The effect of a tailored~     transition package on patient's outcomes (disease activity, flares, hospitalizations) during~     the first year following transition.~   "
51434|NCT02893657|"~     The aim of the present study is the evaluation of the occurrence and effect of hepatic~     dysfunction on outcome following cardiac surgery, as well as the monitoring of changes in~     liver haemodynamics in the early postoperative period.~   "
51435|NCT02893644|"~     Prospective study aiming to measure central ablation depth during excimer laser surgery in~     myopic patients operated with femtosecond laser assisted LASIK with intraoperative OCP,~     before and after laser ablation. This measurement will be compared with pre and 1 month~     postoperative topography differential pachymetric measurements.~   "
51436|NCT02893631|"~     Stroke treatment includes thrombolysis, thrombectomy for patients with proximal artery~     occlusion and sometimes neurosurgery. It rises questions regarding hemostasis: thrombolysis~     induces fibrinolysis but its effects on coagulation, fibrinogen and platelets and duration of~     these effects are unknown. Thus management of antithrombotics and hemostasis during~     thrombectomy and surgery is an issue.~      Objectives : to describe thrombolysis-induced hemostatic disorders (fibrinolysis,~     coagulation, fibrinogen, platelets) in patients requiring thrombectomy for stroke and to~     evaluate the time required for the normalization of these disorders.~      Methods : Observational monocentric study including rtPA-treated patients requiring~     endovascular treatment for stroke. Blood sampling within the first 48 hours after rtPA~     administration to assess of fibrinolysis, coagulation and platelet functions with point of~     care devices and specific laboratory tests. Record of clinical and biological data.~   "
51437|NCT02893618|"~     Open label, parallel-group, single site, 5 treatment-period study with 4 dose levels of DCCR,~     1 of which is administered both with and without food.~   "
51438|NCT02893605|"~     This is a case-control study performed on a biological collection. The polymorphisms present~     on a pre-defined list of genes will be studied for 400 Amyotrophic Lateral Sclerosis~     (sporadic type) DNA samples and 400 control DNA samples.~   "
51439|NCT02893592|"~     The photorefractive keratectomy was the first correction mode refractive laser. It's a~     photo-ablation of a predetermined thickness of anterior corneal stroma. Debridement of~     epithelium can be done either mechanically (m-PRK) or by laser (trans-PRK). Trans-PRK has a~     lot of interests: facility and speed of procedure as well as suppression of human variable.~     Very good results are obtained by m-PRK. The aim of this study is to show equivalence or non~     inferiority of trans-PRK over conventional m-PRK in terms of safety and refractive efficiency~   "
51451|NCT02893436|"~     The purpose is to calculate the time for an optimal recovery (T4/T1 > 0.9) from the moment~     when 2 responses to double burst stimulation are visually identical and this for 95% of~     patients.~   "
51440|NCT02893579|"~     This is a single center, randomized controlled trial which will include women with ischemic~     heart disease to receive either a self-directed stress reduction program delivered through a~     smart-phone application or activity tracking only for the first month (early SR~     intervention and delayed SR intervention, respectively). Patients will be monitored for 1~     month for application use and step counts via telephone or email interview and/or collection~     of screen-captured data. Baseline questionnaires will be repeated at the end of one month to~     assess for all primary and secondary measures, at which time the control group (activity~     tracking only) will be introduced to the intervention program. The early SR intervention~     group will not receive a new intervention but will be encouraged to continue using the app.~     Data will be collected for an additional 2 months with all participants in both groups. After~     the three-month study period, the study will close with the collection of final questionnaire~     data.~   "
51441|NCT02893566|"~     This is an eight-month research project using one group pretest-midst-posttest design. This~     study is based on self-efficacy and self-regulation of Social Cognitive Theory. The~     investigators will recruit 50 university students with a body mass index of 24 kg/m2 or above~     at one university campus. Participation is completely voluntary. After pretesting, a 12-week~     Mi Band Step Challenge will be launched immediately. Participants will be assessed with the~     validated instruments of International Physical Activity Questionnaire (IPAQ)-Taiwan~     short-form, Sedentary Behavior Questionnaire (SBQ), self-efficacy and self-regulation~     questionnaires. Mi Band activity trackers will be used to monitor step counts. An ioi 353~     body composition analyzer will be used to assess body composition. Data will be analyzed~     using generalized estimating equation (GEE).~      The expected outcomes of this study include: (1) Mi Band Step Challenge will be developed~     based on the theory, which is expected to be effective. If this is true, the intervention can~     be packaged and applied at different types of colleges and universities with overweight~     students. (2) Mi Band Step Challenge has the potential to be used for the reference of the~     healthy weight - physical activity, which is embedded in the School Health Promotion Program~     executed by the Ministry of Education. (3) The result of this study can serve as an example~     for the promotion of evidence-based health care.~   "
51442|NCT02893553|"~     Dysregulation of blood pressure (BP), secondary to decentralized autonomic nervous system~     (ANS) control of the cardiovascular system, often results in chronic hypotension and~     orthostatic hypotension (OH) in persons with spinal cord injury (SCI), particularly in those~     with high cord lesions (i.e., above T6). While most hypotensive individuals with chronic SCI~     remain asymptomatic and do not complain of symptoms associated with cerebral hypoperfusion,~     evidence of reduced resting cerebral blood flow (CBF) has been reported in association with~     low systemic BP in the SCI and non-SCI populations. Reduced CBF in hypotensive individuals~     may lead to cognitive dysfunction, and we reported significantly impaired memory and~     marginally impaired attention processing in hypotensive individuals with SCI compared to a~     normotensive SCI cohort. Furthermore, we found that CBF was not increased during cognitive~     testing in individuals with SCI, which may contribute to impaired cognitive function compared~     to non-SCI controls. Although asymptomatic hypotension may have an adverse impact on~     cognitive function and quality of quality of life (QOL) clinical management of this condition~     is extremely low. In fact, we reported that while nearly 40% of Veterans with SCI were~     hypotensive, less than 1% carried the diagnosis of hypotension or were prescribed an~     anti-hypotensive medication. The discrepancy between incidence and treatment of asymptomatic~     hypotension in the SCI population may relate to a paucity of treatment options which are~     supported by rigorous clinical trials documenting safe and effective use of anti-hypotensive~     therapy on BP, CBF and cognitive function. We hypothesize these study medications may~     increase systolic blood pressure to the normal range and improve cerebral blood flow~     velocity. Results and conclusions will not be removed from the record.~   "
51443|NCT02893540|"~     The optimum regimen of maintenance treatment after first-line chemotherapy in patients with~     metastatic colorectal cancer (mCRC) is unknown. This study was designed to determine the~     efficacy and safety of maintenance treatment with capecitabine metronomic chemotherapy versus~     conventional chemotherapy.~   "
51444|NCT02893527|"~     Evaluate and compare the return to work rate at 12 months~   "
51445|NCT02893514|"~     This study will develop a clinical decision support tool that assists primary care providers~     in carrying out substance use interventions, and then compare (in Phase 2) two clinical~     scenarios, screening only (SO) vs. SUSIT, (on dose of substance use brief intervention~     received) and changes in drug use at 3 and 6 months, among primary care patients.~     Investigators will develop the Clinical Decision Support (CDS) component and then test the~     full SUSIT approach, using mixed methods to assess its acceptability and adoption, and~     gathering preliminary data on its efficacy for reducing unhealthy drug use. CDS development~     is concurrent with the SO phase to avoid losing valuable time, but will be conducted at a~     secondary study site to avoid contaminating the SO condition.~   "
51446|NCT02893501|"~     The objective of this study is to evaluate the microbiome composition of infant's (9-12~     month) skin experiencing diaper rash in order to determine if the onset and severity of~     erythema associated with diaper rash is influenced by the type of bacteria colonizing the~     skin.~   "
51447|NCT02893488|"~     This is an open-label, randomized, crossover study in healthy adult subjects with 5 treatment~     groups over 5 dosing periods. This study will evaluate pharmacokinetic parameters and~     relative bioavailability of a dispersible, fixed-dose combination (FDC) tablet of TRIUMEQ™~     ([abacavir, ABC]/[dolutegravir, DTG]/[lamivudine, 3TC]) when dispersed and consumed under~     four different dosing conditions in comparison to an oral dose of TIVICAY™ (DTG) + EPZICOM™~     (ABC/3TC) non-dispersible tablets administered in the fasted state. Approximately 20 subjects~     will be randomized, each to one of 5 treatment groups. The total duration of participation of~     a subject in this study will be approximately 10-11 weeks. It will include a screening visit~     within 30 days prior to the first dose of study drug, five treatment periods each with a~     single dose of study drug per treatment period and a follow up visit within 7 10 days after~     the last dose. There will also be a washout of at least 7 days between doses in each~     treatment period. TRIUMEQ, EPZICOM, and TIVICAY are trademarks of the GlaxoSmithKline group~     of companies.~   "
51448|NCT02893475|"~     Living donor (LD) kidney transplantation is currently the best treatment for end-stage renal~     disease (ESRD) in terms of life expectancy and quality of life. This method allows preemptive~     transplantation, before beginning dialysis.~      The main objective of this study will be to investigate quality of life and societal~     participation in a population of LD kidney transplant recipients comparing preemptive LD~     transplantation versus non-preemptive transplantation (performed after a period of dialysis).~   "
51449|NCT02893462|"~     The aim of this study is the establishment of a warehouse physiological data and biomedical~     signal in intensive care adult patients in acute situations from particular records from the~     Philips Intellivue MP70 monitor.~   "
64073|NCT02728297|"~     Evaluation of staged endoscopic thoracoscopic sympathicotomy in treatment of~     palmo-axillo-plantar hyperhidrosis~   "
51455|NCT02893384|"~     Pain following mastectomy surgery for breast cancer can be significant. Poorly managed pain~     in the immediate time-period following surgery can potentially lead to long-term (chronic)~     pain conditions. There is still a need to find the safest, least invasive, and most effective~     method to manage this pain. The investigators believe that a new technique of injecting local~     anesthesia (freezing) in to specific areas at the end of mastectomy surgery may be a very~     important step to managing pain after breast surgery. The investigators would like to begin~     by performing a pilot study, meaning the investigators will perform the technique in patients~     and compare what their pain outcomes are to patients who have not had the technique.~   "
51456|NCT02893371|"~     The objective of this retrospective observational study is to compare commonly prescribed~     bipolar disorder medications for their impact on: (1) all-cause mortality; (2)~     hospitalization; (3) mood episodes; (4) suicide attempts and self-harm; and (5) risk of~     drug-induced adverse effects such as kidney disease/failure and metabolic syndrome. In~     addition, the investigators will examine heterogeneity of treatment effect by co-morbidity~     within pediatric, adult, and elderly sub-populations. Patient focus groups are convened to~     elicit additional questions and provide feedback on results.~   "
51457|NCT02893358|"~     The primary purpose of the study is to estimate the target organ protection after 12 months~     of antihypertensive treatment in masked hypertension patients with at least one kind of~     target organ damage (left ventricular hypertrophy, large arterial stiffness and~     microalbuminuria). Improvement was defined as the relevant parameter back to normal or~     declined at least 20%.~      The secondary objectives include: blood pressure lowering effect, target organ damage~     parameters improvement, and the incidence rate of all cause death and cardiovascular events~     (stroke and myocardia infraction).~   "
51458|NCT02893345|"~     People who sustain moderate to severe traumatic brain injury (TBI) have an increased risk for~     unintentional injury and harm when resuming day to day activities in the home and community.~     People who sustain brain injuries primarily want to independently do the activities they~     enjoy while families primarily focus on avoiding injury or other harm events. Safe@Home is an~     injury prevention education and activity training program. Participants who have sustained a~     moderate or severe TBI receive a personalized strengths and safety risk assessment, tailored~     injury prevention education, and in-home training with a transition coach on self-selected~     activities. This study will evaluate whether the Safe@Home program reduces injuries and harm~     and increases clients' independence in their everyday activities in the home and community~     compared to a usual care control group.~   "
51459|NCT02893332|"~     To tested if the adding of consolidative SBRT to TKI in EGFR mutated patients with less than~     or equal to 5 metastatic sites (primary + 5) will improve progression free survival (PFS)~     compared to TKI alone.~   "
51460|NCT02893319|"~     Rapid growth early in infancy is a risk factor for obesity and cardiovascular disease later~     in the lifespan. Evidence is limited, but both pre- and postnatal factors are associated with~     early rapid growth, and include high maternal BMI prior to pregnancy and excessive~     gestational weight gain. This research focuses on aspects of early feeding as potentially~     modifiable factor affecting early infant weight gain. Formula feeding mothers are randomized~     to receive either 5 oz of 8 oz bottles to use in feeding their infants from 2- to 16 weeks~     postpartum. In addition, a reference group of exclusively breastfeeding mother-infant dyads~     are also included. The hypothesis is that differences in feeding practices will be associated~     with differences in growth and that infants randomized to be fed from smaller bottles will~     grow more slowly that those randomized to larger bottles. Growth patterns of formula fed~     infants will also be compared to those of exclusively breastfed infants.~   "
51461|NCT02893306|"~     The purpose of this study is to evaluate whether the administration of multipotent stromal~     cell also referred as to mesenchymal stem cells (MSCs), modified Type 1 Diabetes progression.~   "
51462|NCT02893293|"~     The goal of the project is to evaluate osteonecrosis before and after decompression surgery~     with ferumoxytol-enhanced MRI.~   "
51463|NCT02893280|"~     ACSSLAP is the first island wide audit project in Sri Lanka on ACS.~   "
51464|NCT02893267|"~     Hemiplegic shoulder pain (HSP) affects up to 60% of moderate to severely impaired stroke~     survivors. HSP is associated with poor rehabilitation outcomes, including interference with~     activities of daily living (ADLs) and poor quality of life (QoL). While many treatments for~     HSP have been proposed, most do not result in long-term relief of pain.~      The investigators developed the use of intramuscular peripheral nerve stimulation (PNS) for~     the treatment of HSP, which involves the temporary placement of a percutaneous intramuscular~     electrode to stimulate the axillary nerve motor points to the deltoid muscle. A systematic~     review of randomized controlled trials (RCT) concluded that intramuscular PNS was the only~     treatment to provide long-term relief of pain for those with HSP. However, physical therapy~     (PT), which focuses on correcting biomechanics, is the most commonly prescribed treatment for~     HSP and is recommended by multiple practice guidelines. Prior to acceptance by the clinical~     community, the superiority of PNS to a course of PT must be demonstrated. The investigators~     completed a pilot RCT comparing PNS to PT and 67% vs. 25% of participants experienced~     successful pain relief (i.e., ≥ 2-pt or 30% reduction) from PNS and PT, respectively. Thus,~     the primary objective of this 2-site RCT is to confirm the findings of this preliminary pilot~     RCT. Combining PNS and PT, which may be how PNS is actually implemented in clinical practice,~     may have a synergistic therapeutic effect. Thus, the second objective of this RCT is to~     determine if multimodal treatment of HSP with PNS + PT is more efficacious for pain relief~     than PNS alone or PT alone. Mechanisms also will be explored.~   "
51465|NCT02893254|"~     Study of the efficacy and safety of IBI303 compared with adalimumab in adult patients with~     ankylosing spondylitis (AS) who have had an inadequate response to or who are intolerant to~     one or more nonsteroidal anti-inflammatory drugs (NSAIDs)~   "
51466|NCT02893241|"~     This is a national, multicentre, prospective, open, two-arm, non-interventional study with~     hospitalized patients, who are treated routinely with cafedrine/theodrenaline or ephedrine~     after occurrence of perioperative hypotension, wherein the patients are assigned to a~     treatment arm based on the department.~   "
52060|NCT02885480|"~     Describe and analyze routes and modes of care for patients in emergency consultant in various~     emergency care and public psychiatric outpatient devices to provide useful information to~     optimize trajectories taken into psychiatric load on the Eurométropole territory upstream and~     downstream of where they viewed urgently.~   "
51467|NCT02893228|"~     Hemi-diaphragmatic palsy is a common undesirable effect of interscalene block, with an~     incidence of up to 100%. Mechanism of palsy is thought to be related to spread of local~     anaesthetic anterior to the anterior scalene muscle. We hypothesize that by injecting saline~     in this anatomical location prior to performing an interscalene block the incidence of~     phrenic palsy will be reduced.~   "
51468|NCT02893215|"~     The primary aim of the present study is to screen high-risk type 2 diabetes patients and~     heart failure patients without any history of atrial fibrillation (AF), ongoing oral~     anticoagulation (OAC) treatment, implanted device or recent stroke/Transient Ischemic Attack~     (TIA), for silent AF.~      Moreover, we aim to establish the prevalence of two or more risk factors for stroke in~     patients with heart failure and diabetes mellitus type 2 (DM2) with the aim of assessing the~     feasibility for this group to undergo AF screening.~      Overall, the aim of the study is to prevent stroke in high-risk patients groups through~     identification of silent (asymptomatic) atrial fibrillation.~   "
51469|NCT02893202|"~     The purpose of the research project was to assess changes in Posttraumatic stress disorder~     [PTSD] symptoms, quality of life and participation of combat veteran who participate in~     equine assisted activities [EAA]. The study used a mixed-methods, waitlist-controlled,~     repeated measures trial of a standardized 8-week therapeutic riding intervention for combat~     veterans with PTSD. Behavioral changes were assessed four times during the study. Veterans~     meeting inclusion criteria were selected to participate in either the intervention group or~     the control/waitlist group.~   "
51470|NCT02893189|"~     Eligible patients will receive escalating doses of 4G7-CARD T-cells paralleling clinical~     standard of care with unmanipulated donor lymphocytes. There are 3 intra-patient dose levels~     planned.~      Patients will be followed up regularly during the interventional phase of the study until 12~     months post-final 4G7-CARD T-cell infusion. Thereafter patients will be followed up annually~     for years 2 and 3.~   "
51471|NCT02893176|"~     Potential therapy with MACITENTAN in the treatment of Chronic Lung Allograft Dysfunction~     (CLAD) after Lung Transplantation. Pilot Study, Double-blind, ADD-ON Therapy with~     MACITENTAN to usual standard of care immunosuppressive therapies after lung transplantation~     for established BOS Stages I or II versus a matched control group who receive usual~     standard of care immunosuppressive therapies alone, results in a decrease in the Primary~     Endpoint: rate of decline in Forced Expiratory Volume-1 sec (FEV1) versus time while~     Secondary Endpoints including: differences in Six minute walk distance (6MWD), BORG Score,~     corrected single-breath diffusing capacity (DCO corrected) at time intervals of 1, 3, 6~     months on therapy. Specific biomarkers for BOS, including inflammatory chemokines, which are~     routinely collected in the context of post-transplant surveillance will be analyzed.~     Chemokines which our group has previously described in the pathogenesis of the continuum of~     acute-to-chronic lung allograft rejection, have included both C-C (CCL2, CCL5) and CXC~     (CXCL9, CXCL10, CXCL11) chemokines as determined in bronchial-alveolar lavage (BAL).~   "
51472|NCT02893163|"~     The primary purpose of this trial will be to test the effectiveness of CHANGE intervention to~     increase physical activity, improve diets, reduce obesity and reverse Metabolic Syndrome~     among adult patients identified as at risk for cancer due to diet and physical activity~     behaviours when implemented in typical primary care settings within the Alberta context.~   "
51473|NCT02893150|"~     Mindfulness has been applied in the United States and Europe to improve both physical and~     psychological health, however, it is still poorly studied in Brazil. Mindfulness, or its~     lack, may also have particular relevance to obesity and eating disorders, reducing the~     episodes of binge eating, which are partly responsible for weight regain for many people,~     and improving the eating behavior in order to promote awareness of emotional states which~     distort the physiological signals generated by the process. The hypothesis is that~     Mindfulness-based Interventions (MBI) as well as specific programmes focused on conscious~     eating, as Mindfulness Based Eating Awareness Training (MB-EAT) can, in short time, and in a~     sustainable fashion, improve biochemical, psychometric and anthropometric parameters in~     primary care patients with overweight.~   "
51474|NCT02893137|"~     The present study proposes a new and potentially superior clinical approach to Optune™~     therapy of selected glioblastoma patients. The approach is based on combining TTFields with~     targeted surgical skull remodeling, such as minor craniectomy or a distribution of burr~     holes, designed for the individual patient. Pre-clinical modeling results suggest that such~     procedures may enhance the induced electrical field strength by up to ~100% and thereby~     potentially improve the clinical outcome of treated patients to a significant extent.~      The study is an open label phase 1 clinical pilot experiment designed to investigate~     feasibility, safety and efficacy of the concept. Fifteen patients with first recurrence of~     glioblastoma will be included in the trial. All patients will receive TTFields therapy with~     targeted craniotomy and best physician's choice chemotherapy.~   "
51475|NCT02893124|"~     HBeAg-negative chronic hepatitis B (CHB) patients with low Level HBsAg and with a history of~     drug resistance or suboptimal/partial virological response were enrolled. After giving~     informed consent, patients were treated with nucleoside analog(s) (NAs) once a day and weekly~     subcutaneous injections of alfa-2a 180 micrograms/week or peginterferon alfa-2b 80~     micrograms/week for 12 weeks. 12 weeks later, NAs was stopped, patients were treated with~     weekly subcutaneous injections of alfa-2a 180 micrograms/week or peginterferon alfa-2b 80~     micrograms/week. Treatment endpoint was HBsAg loss(＜0.05 IU/mL).~   "
51476|NCT02893111|"~     Neuromyelitis Optica Spectrum Disorders (NMOSD) is characterized by the pathogenic anti-AQP4~     antibody, which can be produced by specific plasma cells. The patients who are not responsive~     to rituximab treatment may be due to the presence of short-lived and long-lived plasma cells.~     Previous studies confirmed that the proteasome inhibitor bortezomib (Velcade®, approved for~     therapy of multiple myeloma) eliminated both plasmablasts and plasma cells by activation of~     the terminal unfolded protein response. Treatment with bortezomib may help deplete plasma~     cells producing auto-antibodies. Therefore, the rationale for using bortezomib in NMOSD is in~     that bortezomib may help eliminate autoreactive plasma cells and reduce anti-AQP4 antibodies~     titers. It is noted that bortezomib may protect astrocytes from NFκB-dependent inflammatory~     damage in early events in NMOSD pathogenesis.~      The purpose of this study is to determine if the drug bortezomib contributes to reduce the~     average relapsing rates (ARRs) and alleviate neurological disability in NMOSD patients.~   "
51477|NCT02893098|"~     A Multi-Centre, Parallel, Double-Blind, Active comparator, Randomised phase III Clinical~     Trial~   "
51478|NCT02893085|"~     The differential diagnosis between benign and malignant bile duct strictures is a difficult~     and demanding task for clinicians. Clinical, biochemical, and radiological characteristics of~     malignant biliary strictures are non-specific and tissue diagnosis is difficult to obtain~     preoperatively. For this reason, there is a need for the development of new diagnostic~     modalities. Of particular interest is the quest of tumor markers secreted or shed in bile by~     tumor cells developing in the biliary tract.~      In addition, patient's tumor molecular profile is the basis for selecting personalized~     therapy. Cholangiocarcinomas are characterized by a large genetic heterogeneity. The most~     frequent mutations are TP53, KRAS, BRAF, EGFR, MET, NRAS, PIK3CA, ERBB2, SMAD4, FBXW7,~     ARID1A, PBRM1, BAP1 et IDH1/2. In the case of pancreatic cancers, the most frequent are KRAS~     mutation detected in 90 % of the patients and CDKN2A, SMAD4, TGFBR1, TGFBR2, ATM, BRCA2,~     MLL2, MLL3, KDM6A, ARID1A, ARID1B, SMARC1, GNAS and RNF43 mutations.~      It is well established that KRAS and P53 mutations can be detected in bile samples from~     patients with biliary strictures related to cholangiocarcinoma and cancer of the head of the~     pancreas. The main objective is to determine if bile sample analysis from patients with~     malignant biliary stricture may allow to identify tumor mutation profile and determine tumor~     genotype. A secondary objective is to evaluate the diagnostic value of Vascular Endothelial~     Growth Factor (VEGF) and metallo-proteinases (MMPs) levels in bile samples.~      Tumor genotyping will be performed in bile samples (supernatant and cell pellet) and tumor~     tissues in a series of 10 patients surgically treated for malignant biliary stricture related~     to cholangiocarcinoma or cancer of the head of the pancreas. The biochemical markers, VEGF~     and MMPs, will be assessed in bile samples obtained during endoscopic retrograde~     cholangiopancreatography in 50 patients with malignant biliary stricture and 50 patients~     treated for benign biliary diseases.~   "
51479|NCT02893072|"~     Gestational diabetes mellitus (GDM) is one of the most frequent complications of pregnancy,~     that affect between 1 to 14% of population around the world. The overall purpose of this~     study is to determine the efficacy of individualized medical nutrition therapy (MNT)~     intervention to reduce and control the development of GDM.~   "
51480|NCT02893059|"~     The main objective of this study is to estimate the reporting bias of patients in terms of~     prescripted drug and care consumption by comparing data collected in a patient diary and~     database of health insurance .~   "
51481|NCT02893046|"~     The main objective of this research is to evaluate a care pathway adapted to different~     category populations at risk of being infected with the hepatitis C virus in order to improve~     both the diagnosis turnaround times and the access to treatment. The aim is to allow a quick~     and effective access to diagnosis and treatment of HCV by strengthening the city hospital~     networks, access to early consultations and coordination of medical social actors.~   "
51482|NCT02893033|"~     The patients with chronic dysphagia secondary to first-ever stroke were randomly assigned to~     2 groups: Group A: sham stimulation for 10 minutes , Group B: real rTMS for 10 minutes. rTMS~     conditioning: daily rTMS 10 min for 10 days. Assessments: 1. videofluoroscopy，2.Functional~     outcome swallowing scale (3 scales). 3. MEP measurements~   "
51483|NCT02893020|"~     Recent studies have highlighted a high incidence of burnout among surgeons. The aim of this~     study is in particular to investigate if this is the consequence of performing surgery (i.e.~     invasive procedures) or whether it is related to the cultural background of surgeons.~   "
51484|NCT02893007|"~     Family interventions have been emphasized in the treatment of BPD and have benefits for~     patients' symptoms and health; however, the effects of family interventions on family~     function and caregivers' health-related outcomes have not been well investigated. This~     randomized controlled trial with 47 hospitalized patient-with-BPD/family-caregiver dyads at a~     medical center in northern Taiwan compared the effects of a brief family-centered care (BFCC)~     program with treatment-as-usual (TAU). The findings support both the feasibility of using the~     BFCC program for inpatients and its specific benefits for family function. An intensive~     family intervention during hospitalization has been suggested in psychiatric practice to~     support patients with BPD and family caregivers.~   "
51485|NCT02892994|"~     This study will compare ultrasound 0.4 W/cm^2 and 100% duty cycle versus no ultrasound~     (placebo) for bilateral masseter myalgia in up to 38 adult women. The dose will be applied~     for 5 minutes on each side. Both the dose and the starting side will be randomized. Both the~     subject and ultrasound operator will be blind to the dose. The outcome measures will be~     pressure pain threshold on both masseter muscles and both temporalis muscles, self reported~     pain scale (0, no pain to 10, worst pain ever), thermographic temperature of the muscles, and~     intraoral temperature. These outcome measures will be taken before and after each dose, so~     three times per subject.~   "
51486|NCT02892981|"~     Aim of the study is to evaluate the role of chemoreceptor activity and ventilation perfusion~     mismatch on the genesis of exercise induced hyperventilation in Pulmonary hypertension~     patients. So the investigators tested the chemoreceptor response at rest, both with hypoxic~     and hypercapnic stimuli, and the ventilatory response during exercise analyzing its two~     components, alveolar and dead space ventilation.~   "
51487|NCT02892968|"~     Hip fractures are common, costly and affect older people - Canadians spend 1 billion dollars~     to treat hip fractures each year. Unfortunately, as many as two-thirds of hip fracture cases~     suffer a complication known as delirium, or acute confusion. Patients with delirium may~     become frightened and agitated. This in turn leads to other serious problems. Having delirium~     doubles the chances of dying or can increase the need for admission into a nursing home.~     People with delirium spend an extra week in hospital on average.~      Using ultrasound to locate and 'freeze' or block specific nerves can stop hip fracture pain~     almost immediately, and use of this technique is known to reduce delirium when administered~     by Anaesthetists to patients at the time of their hip operation. Unfortunately, patients with~     hip fractures commonly wait hours or even days in the Emergency Department (ED) prior to~     their operation. Currently, these patients are given narcotic pain killers like morphine to~     dull their pain, as most ED physicians have not been trained in using this 'freezing'~     technique and Anaesthetists are rarely able to leave the operating room to administer~     freezing to patient in the ED.~      The EDU-RAPID study will test whether training ED physicians on how to use the nerve freezing~     technique will reduce the number of patients who develop delirium after a hip fracture. To~     study this, ED physicians will be trained at 6 hospitals in small groups every 6 weeks over~     18 months. The study will look at how patients who are treated by ED physician who has been~     trained compare to patients treated by a ED physician who has not yet been trained. Also, the~     study will see if the training motivates ED physicians to use the block regularly.~      If correct, this study could significantly improve the comfort, quality of life, and~     independence of patients who suffer a hip fracture. In addition, if the study shows a~     reduction in delirium rates, this could represent a significant cost reduction to the health~     care system.~   "
51488|NCT02892955|"~     The objective of the study is to continue to evaluate safety and clinical performance of the~     HM3 LVAS for the treatment of advanced, refractory, left ventricular heart failure following~     completion of enrollment in the the MOMENTUM 3 IDE Study.~   "
51489|NCT02892942|"~     To overcome unsuitable effects of controlled ovarian hyperstimulation (COH )while maintaining~     large oocyte availability, investigators elaborated an innovative protocol (NATural Ovarian~     Stimulation) that dissociates E2 production from multiple follicle development.~      The purpose of this prospective, randomized trial is to demonstrate that, in a good prognosis~     IVF-ET population, the physiological E2 environment resulting from NATOS significantly~     improves IVF-ET outcome when compared to the conventional GnRH antagonist protocol.~   "
66401|NCT02697838|"~     A single arm study: Apatinib plus paclitaxel as the reverses treatment in advanced gastric~     cancer which paclitaxel-resistant.~   "
51491|NCT02892916|"~     Postoperative delirium is a frequent complication of major surgery and affects 10% to 70% of~     surgical patients > 60 years. Delirium is associated with increased morbidity and mortality,~     prolonged recovery, functional and cognitive dysfunction with nursing home or long-term care~     facility placement. The acute deterioration in cognition and psychomotor agitation frequently~     seen with delirium is often distressing for both patients and their relatives. The~     pathophysiology and causal relationship between delirium and persistent postoperative~     cognitive dysfunction remain incompletely understood. Identified clinical risk factors for~     both include advanced age, type of surgery, preexisting cognitive impairment, and drug~     addiction. The inflammatory response triggered by surgical trauma and pain may contribute to~     the development of delirium and cognitive impairment after surgery.~      Ketamine, a N-methyl-D-aspartic acid receptor antagonist, is commonly used in anaesthesia and~     postoperative analgesia. By reducing both pain and glutamate excitotoxic effects on neuronal~     and microglial brain cells, it contributes to tone down the neuroinflammatory process~     associated with surgery. A recent body of evidence has shown that ketamine reduces the~     depressive-like behavior induced by inflammatory or stress-induced stimuli in mice. Ketamine~     was also found to reduce by 28% the absolute risk of postoperative delirium and levels of~     inflammatory biomarkers in cardiac surgical patients.~      Orthopaedic surgery is a high-risk situation for developing postoperative delirium. In~     patients undergoing total hip or knee replacement, the prevalence (incidence, respectively)~     of delirium is 17% (12-51%, respectively) and it is associated with a 6-fold increase~     increased risk of developing dementia and cognitive dysfunction after surgery. Hundred~     thousands of patients > 60 years undergo elective orthopaedic procedures per year around the~     world. The purpose of the study is to assess the superiority of ketamine at subanaesthetic~     dose versus placebo to reduce the incidence of postoperative delirium in patients aged ≥ 60~     years undergoing elective orthopaedic surgery under general anaesthesia.~   "
51492|NCT02892903|"~     A randomised controlled trial to compare two strategies for the investigation of coronary~     artery disease at the time of angiography. Patients will be randomised to conventional~     angiography or additional, routine pressure wire assessment - measuring fractional flow~     reserve (FFR) - in all main vessels judged as being of sufficient vessel calibre to allow~     percutaneous coronary intervention (PCI) (experimental arm).~   "
51493|NCT02892890|"~     Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) is an acquired neuropathy~     characterized by an inflammatory multifocal segmental demyelination. Due to the clinical~     heterogeneity of this condition and the lack of specific marker that can reliably identify~     all patients, the diagnosis of CIDP remains difficult. Similarly, there are no clear factors~     predicting the evolution or the prognosis of the disease. Current treatments are the~     intravenous immunoglobulin (IVIg), corticoids and plasma exchange; IVIg therapy being the~     most commonly used. Responses of the patients to the treatments are variable. Thus, it is~     necessary to identify predictive markers of the therapeutic response of CIDP patients treated~     by IVIg.~      Several potential biomarkers have been proposed recently, but none of them has yet been~     validated as a predictive criterion for therapeutic response. It is therefore necessary to~     continue to investigate several biological parameters to identify a reliable biological~     marker.~      In electromyography, the Motor Unit Number Index (MUNIX) technique allows measuring the~     axonal loss by a precise count of functional motor units. This method, more sensitive than~     the measure of the Compound Muscle Action Potential (CMAP), is rarely used in CIDP. MUNIX~     might be a good tool to better characterize the patients and to follow the course of CIDP. It~     also might be a new sensitive and reliable marker predictive of the therapeutic response.~      Magnetic resonance Imaging (MRI) is increasingly used for the assessment of neuromuscular~     diseases. A recent study on CIDP patients reported a significant decrease of the muscle~     Magnetisation Transfer Ratio (MTR) compared to healthy subjects, correlated to clinical~     parameters. The use of advances MRI techniques could allow characterizing the structure and~     composition of muscle and nerve tissues of CIDP patients. It could also be a mean for~     identifying potential new markers, largely unexplored until now, that might be sensitive to~     disease course and/or IVIg response.~      The objective of this study is to identify predictive markers of the treatment response of~     CIDP patients receiving IVIg.~      This is a prospective observational exploratory study of a cohort of 30 CIDP patients treated~     with IVIg and followed-up during one year.~   "
51494|NCT02892877|"~     The French Gestational Trophoblastic Disease (GTD) centre has been set up and active by~     registering, monitoring and treating women with GTD since november 1999. The aim is to~     improve the management of trophoblastic disease in France.~      About 850 new cases are registered each year and 140 women treated, mostly with chemotherapy~     and surgery.~      The center works as follow, based on a multidisciplinary approach. The policy is that patient~     remains followed by her local physician, but can be seen and treated in the Center at demand~     and that the registry is done on a voluntary basis.~      Each administrative french area has a local expert team (oncologist and gynaecologist) who is~     able to look after the patients with the help of the national reference center physicians~     based in Lyon.~        -  Once a doctor discovers a molar pregnancy, he contacts the center, with the agreement of~          his patient, for an opinion, an advice or simply to report the case.~        -  The center sends to the doctor the informed consent form to be signed by the patient, a~          registering form and information about pathology for patient and physician, and first~          guidelines based on initial pathology report.~      The patient remains followed by her gynecologist, who stays her first interlocutor throughout~     the whole process and she goes to her local laboratory for hCG monitoring;~        -  A letter is sent to the initial pathology laboratory that originally carried the~          diagnosis of molar pregnancy to require slide sending to the pathologist referral center~          (9 experts with a specific pathologist national network) that centrally review initial~          diagnosis.~        -  In the mean time, the data manager collects weekly hCG values to establish a follow-up~          chart. The physician is regularly informed by mail of the hCG evolution.~        -  The local physician is contacted in case of modification of the diagnosis by the~          pathologist expert. The center informs him about length and monitoring methodology.~        -  Emails or letters are sent at each step of the management (at inclusion, at hCG~          negativation, and at the end of hCG follow-up).~        -  In case of abnormal hCG evolution (raise, plateauing or positivity at 6 months,) or if a~          neoplasia is anatomopathologically diagnosed (choriocarcinoma, PSTT or ETT), physician~          is immediately contacted by phone or email by referent gynaecologist. A complete work up~          including pelvic US with Doppler, pelvic MRI, thoraco-abdominal CT-scan with chest~          radiography if pulmonary nodules are present and brain MRI, is planned to determine the~          adequate treatment.~      Very briefly, based on imaging results, FIGO stade and score are calculated to determine the~     risk. In case of low-risk, a monochemotherapy is settled, while a polychemotherapy is started~     in case of high-risk disease.~      The investigators have developped specific expertise at key levels of diagnosis, management,~     follow-up, fertility preservation and treatment.~      Assignments :~        -  Registration and monitoring post diagnosis of complete or partial molar pregnancy,~          choriocarcinoma,PSTT, ETT, atypical placental site nodules~        -  Histopathological analysis and genetics services~        -  Measurement of human chorionic gonadotrophin (hCG) isoforms~        -  Complex gynaecological surgery~   "
51495|NCT02892864|"~     Facial palsy can be divided into supranuclear lesion (central facial palsy) and infranuclear~     lesion such as Bell's Palsy, an idiopathic disease. The peripheral facial paralysis (PFP) is~     a frequent but little-known pathology (20 / 100 000 inhabitants in France a year). Oro-facial~     functions and the ability to convey emotional facial information are seriously affected by~     facial palsy, thereby reducing patient's quality of life. The PFP can have several~     repercussions on the functional, aesthetic, social, occupational and psychological levels.~     Evolution and prognosis depend not only on its etiology and gravity, but also on the~     precocity and the quality of the medical and paramedical care. It is essential to assess~     functional and psychological issues before beginning an adapted global therapeutic care. If~     these depressive symptoms can be explained by multiple factors, the inability to smile would~     be one of the triggering factors of depression. The facial feedback hypothesis could be one~     of many explications because smiling induces a positive emotional state and a feeling of~     well-being. In PFP, patients must cope with their difficulties to smile. Their facial~     behaviour affected their own emotional experiences.~      The main purpose of the present study is to determine if virtual rehabilitation program is~     relevant compared to standard therapy. The second aim is to characterize the efficiency by~     analysing the time required to obtain a stable score of 4 in the Sunnybrook test. A secondary~     objective will be to decrease the functional and social repercussions of the facial paralysis~     with an intensive and targeted therapy of the smile. Furthermore, a virtual rehabilitation~     program will be implemented in an interactive platform.~      To this end, a parallel randomized controlled trial (RCT) of the two groups will be~     conducted: standard therapy versus virtual rehabilitation program. RCT involves a treatment~     in which active participation of the patient is necessary so only the assessment will be~     blinded. Facial motor skills (tongue, mouth and face motricity) are measured using electronic~     devices, objective and subjective evaluation with pragmatic fields such as communication,~     emotion and quality of life. The severity of patient's facial paralysis is appraised by the~     House and Brackmann scale. This global assessment will be conducted before the beginning of~     the therapy and every 3 months during 18 months.~      The patients will be recruited within the Ear, Nose, and Throat (ENT) service after a~     baseline assessment. Simple randomization will be used in order to establish both therapeutic~     groups with 45 patients in each group.~      Group A: Patients taken care in consultation within the ENT service which provides~     oro-myo-functional classical rehabilitation.~      Group B: Patients taken care in external consultation who receive oro-myo-functional~     rehabilitation through a virtual rehabilitation program targeted at the smile, in their place~     of living in virtual conditions.~      The patients must have been diagnosed with unilateral peripheral facial palsy, according to~     House and Brackmann international classification.~      Inclusion time : 18 months~      Between-two-groups analysis will be conducted in order to compare a targeted and intensive~     implementation-intention rehabilitation such as virtual rehabilitation program to standard~     therapy. This virtual therapy will consist in repeating mentally movement desired, so that it~     will be more spontaneously executed in the every-day-life situation.~   "
51496|NCT02892851|"~     Cocaine addiction is a chronic condition with severe cardiac, neurologic, psychiatric and~     social complications. Cocaine is the second most consumed illicit drug in France. Its~     prevalence has been multiplied by 3 between 2000 and 2008, and is still on the rise. Craving,~     the compulsive need to consume, is a key feature of cocaine addiction. It is also predictive~     of treatment efficacy. However, there is no validated treatment for severe cocaine dependence~     yet. Response to current psychological and medical treatment is poor, with 73% relapse after~     3 months. Patients with severe cocaine addiction are thus in a therapeutic deadlock.~      To address these unmet medical needs, the investigators designed a pilot study (n=2) to~     evaluate the safety and the efficacy of the deep brain stimulation of the subthalamic nuclei~     (STN-DBS) in severe cocaine addiction with at least one cardiac, neurologic or psychiatric~     complication. Indeed, compulsivity is a critical component of craving, and severe~     treatment-resistant obsessive compulsive disorder (OCD) are already successfully treated~     using STN-DBS. Moreover, animal studies recently demonstrated a therapeutic effect of STN-DBS~     in rats addicted to cocaine. Together, these two lines of research suggest a therapeutic~     effect of STN-DBS in cocaine addiction mediated by an anti-obsessive mechanism on craving.~   "
51497|NCT02892838|"~     Total Knee Arthroplasty (TKA) is the surgical reconstruction of the knee joint in order to~     relieve pain, restore function and correct deformity. It is a very common surgical procedure~     with figures showing more than 500'000 arthroplasties performed annually worldwide. Total~     knee arthroplasty is considered one of the most successful types of joint reconstruction in~     that surgical results usually meet and even exceed expectations. Much of the current~     literature focuses on the issues relating to implant wear as a potential failure mode for~     artificial knee implants. It has been suggested that knee with mobile or rotating bearing~     options, such as the comparative device proposed for this clinical investigation, may survive~     longer than fixed bearing knee designs because of the greater contact surface area possible~     with more congruent components with unconstrained, mobile component design.~   "
51498|NCT02892825|"~     The purpose of the study is to assess the effect of music therapy on anxiety and hypertension~     during cataract surgery procedures performed under topical anaesthesia.~   "
51499|NCT02892812|"~     The purpose of this study is to evaluate the safety and immunogenicity of LBVE013~     (Pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) or LBVE014~     (Pneumococcal 14-valent conjugate vaccine [diphtheria CRM197 protein]) in healthy adults.~   "
51512|NCT02892643|"~     Experimental: Laparoscopic proximal gastrectomy Laparoscopy proximal gastrectomy with~     esophago-jejunostomy, gastro-jejunostomy and jejuno-jejunostomy (double tract~     reconstruction). Systemic en bloc lymph node dissection is mandatory. Resection margin should~     be negative for malignancy with intraoperative frozen biopsy.~      Active Comparator: Laparoscopic total gastrectomy Laparoscopic total gastrectomy with~     esophago-jejunostomy and jejuno-jejunostomy (Roux-en-Y reconstruction). Systemic en bloc~     lymph node dissection is mandatory. Resection margin should be negative for malignancy with~     intraoperative frozen biopsy.~   "
51540|NCT02892279|"~     The adverse effects of air pollution on cardiovascular and respiratory health have been~     demonstrated in an extensive series of epidemiological, observational and experimental~     studies. In the current project the investigators aim to determine whether an acute exposure~     to diesel exhaust causes impacts on sympathetic nervous system activation in healthy~     volunteers.~   "
51500|NCT02892799|"~     This is a research study about monitoring diuresis in acute respiratory failure. Often,~     patients with respiratory failure have fluid building up in the lungs, which means less~     oxygen can reach the blood stream, which deprives the organs of oxygen. Managing the amount~     of intravenous fluids is crucial to the treatment of respiratory failure. Diuresis, the~     increased formation of urine by the kidney, is one way that fluid balance is maintained.~     Previous studies of respiratory failure suggest that diuretic therapy may be beneficial in a~     group of patients with Acute Respiratory Distress Syndrome, (ARDS), which is a severe type of~     respiratory failure. Although protocols exist for managing fluid status in ARDS, all of them~     require invasive monitoring using a central venous catheter. This study will compare central~     venous catheter-guided diuresis to ultrasound-guided diuresis. Participants in this study~     will be randomized into one of three treatment arms:~        -  Fluid and Catheter Treatment Trial-lite (FACTT-Lite) diuresis arm~        -  Echocardiography diuresis arm~        -  Central venous pressure CVP diuresis arm This research study will assess differences~          in clinical outcomes, number of ventilator free days, ICU free days, 60 day mortality,~          and incidence of acute kidney injury or new shock between the three treatment arms.~   "
51501|NCT02892786|"~     The dissemination of individual tumor cells is a common phenomenon in solid cancers.~     Detection of tumor cells in peripheral blood circulating tumor cells (CTC) in nonmetastatic~     situation is of high prognostic significance.~      The objective of our study was to detect circulating tumor cells in two different method in~     patient with head and neck squamous cell carcinoma .~   "
51502|NCT02892773|"~     The purpose of this study is to better understand how air is spread throughout study~     participants' lungs after abdominal surgery by comparing two lung inflation treatments:~        1. Incentive Spirometry (I.S.) lung expansion therapy~        2. EzPAP® lung expansion therapy.~      Lung expansion therapy is routinely used after upper abdominal surgery. Taking deep breaths~     after surgery helps lungs to stay inflated. At the University of Virginia, it is at the~     physician's discretion as to which treatment will be used to help with deep breathing lung~     inflation therapy after surgery. The investigators would like to know which of the lung~     inflation therapies is better at helping inflate participants' lungs.~      The investigators will be using a device called Electrical Impedance Tomography (EIT) to~     measure how effectively air spreads in participants' lungs. This device is not currently~     approved by the Food and Drug Administration (FDA) for the purpose used in this study, and~     therefore, it is considered investigational.~      Investigators are inviting eligible participants to consider participating in this study~     because doctors order Incentive Spirometry as a standard of care following upper abdominal~     surgery. Information gained from monitoring how air is spread throughout participants' lungs~     will help investigators to determine if there is a clinical difference and benefit when~     comparing Incentive Spirometry and EzPAP lung expansion therapies.~   "
51503|NCT02892760|"~     The purpose of this study is to develop a clinical algorithmic-based evaluation and treatment~     approach for C-Brace for use by persons with hemiparesis or hemiplegia due to stroke.~   "
51504|NCT02892747|"~     The intervention tested in this research project aims to reduce the unplanned~     hospitalizations in CHF patients by preventing the malnutrition using a personalized dietetic~     education program. This new program provides concrete solutions to patients by offering~     balanced menu ideas, adapted to their tastes and social-cultural habits, and a panel of~     recipes easy to make, inexpensive and tasty (despite the lack of salt). This new educational~     program should improve the dietary behavior of patients and reinforce the importance of~     dietary guidance in support of the CHF.~   "
51505|NCT02892734|"~     The purpose of this research study is to look at the efficacy (the effect on tumor) and the~     safety (the effect on body) of the study drugs when given as a combination in patients with~     metastatic recurrent epidermal growth factor receptor 2 (HER2) negative inflammatory breast~     cancer. This is a phase II study of 2 drugs used in combination: nivolumab and ipilimumab.~     The combination of these drugs is already approved by the Food and Drug Administration (FDA)~     to treat advanced melanoma (a type of skin cancer). Nivolumab and ipilimumab are not approved~     by the FDA for patients with metastatic recurrent HER2 negative inflammatory breast cancer,~     hence the treatment is considered experimental or investigational.~   "
51506|NCT02892721|"~     Colorectal cancer (CRC) is an important United Kingdom healthcare issue affecting 1 in 20~     individuals, half of whom will die from the disease. Late presentation of CRC has a poor~     prognosis, whereas excellent cure rates (>95%) are seen in those who present early. Accurate~     and early diagnosis of CRC is therefore crucial. In most patients this is achieved via~     colonoscopy, a camera test which is widely available and allows tissue samples to be taken of~     any abnormalities seen during the procedure. However, a non-invasive alternative is Computed~     Tomography Colonography (CTC) which uses X-rays to produce images of the large bowel which~     are then interpreted by Radiologists. CTC has high sensitivity for the diagnosis of CRC~     (comparable to colonoscopy) and the cancer precursor - adenomatous polyps.~      Unlike colonoscopy, however, there is no accreditation process for CTC and there is no~     infrastructure to ensure that all reporting Radiologists are able to do so adequately and, as~     a result, there is a wide range of diagnostic accuracy. There are no universally-accepted~     standards to monitor quality or assess diagnostic performance, partly because we do not know~     what the quality markers are and there is currently no system to quantify them. Overall, this~     contributes to low cancer detection rates, missed cancers and inequity for patients across~     the National Health Service (NHS).~      This study aims to assess the impact of a structured training programme with assessment and~     feedback on NHS radiologist performance. If the impact is positive and results in~     significantly improved performance, then such a scheme could be adopted into an accreditation~     programme for CTC in the English Bowel Cancer Screening Programme (BCSP).~   "
51507|NCT02892708|"~     The objective of this study is to evaluate the efficacy and safety of surgical resection in~     elderly patients 70 years or older with a supratentorial glioblastoma de novo. The~     sensitivity of Magnetic Resonance Spectroscopy with perfusion sequences in the diagnosis of~     malignant glioma in the elderly will also be studied.~   "
51508|NCT02892695|"~     The purpose of this study is to evaluate the safety and optimal dose of PCAR-119 in patients~     who are going to receive stem cell transplantation but without available treatment to achieve~     complete remission prior to the transplant.~   "
58756|NCT02797808|"~     The investigators will examine how treatment with sertraline for 12 weeks impacts~     frontal-striatal-thalamic circuitry (FSTC) in this OCD sample.~   "
51513|NCT02892630|"~     The pregnancy may activate flares of certain autoimmune diseases such as lupus. The influence~     of pregnancy on the evolution of ITP was never studied while this pathology affects firstly~     women old enough to procreate. Also, the influence of ITP on pregnancy (risk of obstetric~     complications) and on newborns (risk of neonatal thrombocytopenia) is rather unknown and~     never studied in a prospective study. The realization of a prospective study to answer these~     questions is necessary to allow us to inform better the patients affected by ITP and to~     define better in this context the strategy of supervision of the mother, the foetus and the~     newborn. The highlighting of risk factors of ITP flare or obstetric or neonatal complications~     will indeed allow the implementation of prevention measures.~      The conclusions of this study will allow us to adapt national guidelines for ITP during~     pregnancy.~   "
51514|NCT02892617|"~     Low back pain is one of the most frequent reasons for consultation in rheumatology. There is~     a strong correlation between low back pain, and the presence of a type of Modic 1 signal on~     MRI.~      The anomaly Modic 1 results in a hypointense signal T1-weighted images and hyperintense on~     T2-weighted sequences (including T2 STIR and / or Fat Sat) and contrast enhancement of the~     endplates after gadolinium injection; it corresponds to a replacement of normal cancellous~     bone of fibrovascular tissue.~      The origin of this inflammatory process Modic 1 into the vertebra is still unknown.~      infectious hypothesis was raised, including contamination by germs called slow-growth such~     as Propionibacterium acnes (PA).~      Many studies interesting Bacteriological analysis of disc material found the presence of~     bacteria (prevalence between 0 and 54%).~      A recent clinical trial evaluating the efficacy of antibiotic treatment compared to placebo~     in low back pain with Modic 1; a show effectiveness of this treatment on the different~     clinical parameters evaluated.~      However skin contamination is not formally excluded, particularly in patients previously~     infiltrated (including epidural).~      Our hypothesis is that the slow-growing bacteria are not involved in Modic 1 type of disc~     disease, and the possible presence of PA or other slow-growing bacteria in samples obtained~     discal posterior approach would be related to intraoperative contamination or during~     preoperative spinal infiltrations The main objective is to assess the prevalence of germs~     slow growth in the intervertebral disc in the spinal surgery by anterior disc disease in type~     1 Modic.~   "
51515|NCT02892604|"~     A new version of the DiAs artificial pancreas (AP) system has been developed in view of wide~     scale outpatient trials. Denominated as inControl , it includes improved user interface and~     communication modules while closed-loop algorithms remain similar. During this pilot study,~     the investigators will evaluate this new version of AP for a two-week period during which the~     patients will use it for closed-loop insulin delivery 24/7 The main goal is train the~     clinical team with the new system and collect patient opinions on system acceptance from~     questionnaires. If this trial is conclusive, a randomized 6-month multicentre study including~     240 patients will be initiated. A total of 5 patients will be included in this training study~     over a 4-week period.~   "
51516|NCT02892591|"~     This study investigates the ability of cannabis to reduce chronic back and neck pain and to~     reduce sensitivity to an acute painful stimulus. Cannabis will be compared to both oxycodone~     and a placebo.~   "
51517|NCT02892578|"~     Atrial fibrillation is the most common arrhythmia. Some studies shown that systematic~     screening with electrocardiogram could improve atrial fibrillation detection. No studies are~     available in nursing home. The goal of this study is to screen atrial fibrillation in~     patients who live in nursing home.~   "
51518|NCT02892565|"~     The purpose is to determine the hypercoagulable phenotype by thrombinography associated to an~     increased risk of symptomatic and objectively confirmed first venous thrombotic event. This~     is a case-control study in a population with patients having systemic lupus erythematosus~     (SLE) and/or antiphospholipid antibodies (APL).~      Secondary purposes are:~        1. To determine the frequency of hypercoagulable phenotype in study population;~        2. To analyze the sensibility: consequences of variation of hypercoagulable phenotype~          threshold on the importance of risk;~        3. To identify (genetic and not) factors for hypercoagulable phenotype and their frequency~          in different groups.~   "
51519|NCT02892552|"~     Objective: To evaluate the diagnostic concordance between multislice computed tomography~     (MSCT) and cone beam computed tomography (CBCT) in the early postoperative assessment of~     patients after cochlear implantation.~      Study Design: Prospective, randomized, single-center, interventional, pilot study on the~     diagnostic performance of a medical device.~      Setting: Tertiary referral center. Patients: Patients aged over 18 years requiring a CT scan~     after cochlear implant surgery.~      Interventions: Nine patients were implanted with electrode arrays from three different~     manufacturers, including one bilateral. High-resolution MSCT and CBCT were then performed,~     and 2 experienced radiologists blinded to the imaging modality evaluated the randomized~     images, twice.~   "
51520|NCT02892539|"~     The purpose of this study is to evaluate the radiation exposure in patients undergoing~     coronary angiography, and to identify reference values for the main radiation doses~     parameters.~   "
51521|NCT02892526|"~     The purpose is to determine intrinsic properties of various immunohistochemical markers~     (FVIIIra, CD15, CD30, tryptase, TNFα, IL-1β, TGFα et TGFβ1) for diagnosis of vital wound,~     alone and in association (evaluation of sensibility with surgery wounds and evaluation of~     specificity with post-mortem wounds).~      Secondary purposes are to measure the minimum time to obtain a positive labeling in vital~     wounds, and to evaluate inter-observer reproducibility of vitality diagnosis with different~     markers. Expression of microRNA miR 9, miR 21 et miR 198 will be also studied.~   "
51538|NCT02892305|"~     The goal of this study is to evaluate and describe the surgical and overall outcomes of~     subjects who undergo pancreatectomy and hepatic resection/ablation for pancreatic cancer with~     low-volume hepatic metastases, as part of routine care. Subjects will be followed to~     determine operative risks and 90-day morbidity and mortality. In addition, survival outcomes~     will be compared to historical controls who did not undergo surgery. Secondary outcomes will~     include mortality and morbidity; operative time; blood loss and transfusion requirements; and~     oncologic outcomes such as: margin status, lymph node harvest, disease-free survival, and~     overall survival. Analysis of subject and tumor characteristics will help the investigator~     identify subjects who would benefit from this aggressive multimodal approach.~   "
51539|NCT02892292|"~     The objective of this study is to realize the typing of all HLA loci and validate this~     technique with continued optimization of next-generation sequencing technology (NGS).~   "
51522|NCT02892513|"~     Pain after surgery is unavoidable, and opioid medications are the cornerstone of most pain~     management regimens. However, they come at a cost with profound impacts on gastrointestinal~     motility, respiratory depression, and even long-term dependence. Stimulating the external ear~     with cutaneous electrical current is similar to acupuncture and could help improve~     postoperative pain. The Bridge device (manufactured by Key Electronics [Jeffersonville, IN,~     USA] and distributed by Innovative Health Solutions [Versailles, IN, USA]), has been used~     with success in treating opioid withdrawal and in animal studies has shown increases in pain~     thresholds. The investigators propose a prospective, randomized, placebo-controlled,~     double-blinded trial to evaluate if auricular neurostimulation improves postoperative pain~     and reduces opioid requirements for patients undergoing elective colon surgery.~      pain perception in post-operative patients may be modulated via the auricular branch of the~     vagus nerve. This has the potential to reduce the use of opioid medications, which will in~     turn reduce the incidence of postoperative ileus and reduce patient need for and dependence~     on narcotic pain medications. This would have an enormous economic impact due to decreased~     length of hospital stays for patients who undergo abdominal surgery. In addition, opioid~     reduction could potentially lessen the national crisis of opioid addiction.~   "
51523|NCT02892500|"~     This study evaluates the use of corticosteroids acutely as an adjuvant treatment of the high~     ankle sprain. Subjects will receive either a corticosteroid or a local anesthetic injection.~   "
51524|NCT02892487|"~     Toxicity and mainly dysphagia have increased in head and neck cancers as chemoradiation~     indications have risen over the last decade, leading to a significant loss of quality of life~     for patients. Recently, many retrospective studies and two evidence-based and systematic~     reviews on strategies to reduce radiation-induced dysphagia have suggested a trend toward~     benefit for a preventive swallowing exercise program.~      The main hypothesis of this study is that an early active swallowing therapy can improve the~     Quality of Life (QoL) of patients treated by radiotherapy for head and neck cancer.~      The study will be a randomized controlled, open-label, multicentric phase III clinical trial~     comparing early active swallowing therapy versus non specific swallowing management (usual~     care).~   "
51525|NCT02892474|"~     The purpose of the study is to find out if hybrid coronary revascularization (HCR) and~     coronary artery bypass grafting (CABG) procedure outcomes are similar. HCR is a combination~     of surgery and catheter procedures to open up clogged heart arteries. CABG is a surgical~     procedure to open up clogged heart arteries.~   "
51526|NCT02892461|"~     This study aims to determine whether umbilical cord milking can improve iron related health~     outcomes for cesarean-delivered infants. Half of participants will receive umbilical cord~     milking, while the other half will receive routine clinical treatment and care.~   "
51527|NCT02892448|"~     There may be a relationship between heart function and the metal ION levels in patients~     having undergone total hip replacement. The idea is to use results from a clinical cardiac~     MRI to assess heart function in a sample of 30 patients whom have undergone either~     metal-on-metal hip replacement (unilateral or bilateral) or a non-metal on metal total hip~     replacement to determine whether having undergone a metal on metal hip procedure may be~     impacting heart function. In addition to the clinically used parameters, the images will also~     be retrospectively assessed using special software to assess amount of fibrosis and early~     changes affecting cardiac muscle contraction which may be indicative of impaired heart~     function. With these values we will compare to known, and previously collected, hip~     replacement and function data to determine whether there is any differences in how the heart~     works in those having had a hip replacement relative to a normal population.~   "
51528|NCT02892435|"~     Comparison in abdominal wound healing after contaminated or dirty surgery with incisional~     negative pressure wound therapy versus standard dressing.~   "
51529|NCT02892422|"~     To evaluate the safety and tolerability of the long-term treatment with Lu AF35700.~   "
51530|NCT02892409|"~     To evaluate the safety, tolerability, and pharmacokinetics (PK) of quadruple therapy with~     bismuth, clarithromycin, amoxicillin, and TAK-438 versus quadruple therapy with bismuth,~     clarithromycin, amoxicillin, and lansoprazole.~   "
51531|NCT02892396|"~     This study evaluates the local and systemic inflammatory response in the airway in COPD~     patients who consume electronic cigarettes compared with conventional cigarette smokers.~   "
51532|NCT02892383|"~     The aim of the project is to improve quality of life for multiple myeloma patients in the~     future.~   "
51533|NCT02892370|"~     The purpose of this open-label, randomized, two-period, two-treatment (single doses of 10 mg~     SHR0302 fasted or fed), crossover study was to evaluate the effect of a high-fat meal on the~     pharmacokinetics of SHR0302 and mass balance study in 14 healthy subjects.~   "
51534|NCT02892357|"~     Randomized, double-blind, active-controlled, multi-center phase 2 clinical trial to~     investigate the safety, tolerability and efficacy of Jianpi Qinghua granule combine and Low~     dose omeprazole in patients with non-erosive reflux disease (NERD)~   "
51535|NCT02892344|"~     The purpose of the trial is to evaluate efficacy and safety of QMF149 150/80 microgram o.d.~      delivered via Concept1 compared to MF 200 microgram o.d., delivered via Twisthaler® in terms~     of lung function and symptom control in poorly (ie inadequately) controlled asthma patients.~     This study will assess contribution of LABA as an add-on therapy to low dose ICS monotherapy.~   "
51536|NCT02892331|"~     African Americans are at a substantially greater type 2 diabetes risk compared to Caucasians;~     however, very little data are available on the effects of exercise training on type 2~     diabetes risk factors in at risk African Americans. The present proposal will evaluate the~     effects of 6 months of moderate versus vigorous intensity aerobic exercise training on~     fitness, insulin sensitivity, mitochondrial capacity, skeletal muscle oxidative/insulin~     sensitivity markers, adiposity, and quality of life in African Americans.~   "
51537|NCT02892318|"~     This is a non-randomized, open-label, Phase Ib study of atezolizumab in combination with~     immunomodulatory agents for the treatment of participants with AML (relapsed/refractory and~     treatment-naive, elderly participants unfit for induction chemotherapy). The study has been~     designed with the intent, over time, to study multiple combinations of atezolizumab with~     different immunomodulatory agents in participants with AML. The study will begin with the~     evaluation of the combination of atezolizumab and guadecitabine (Arm A). In the future,~     additional arms may be added.~   "
51541|NCT02892266|"~     This study is conducted to better understand Post-Traumatic Stress Symptoms (PTSS) in~     adolescent transplant recipients and their parent/guardian and to see if PTSS play a role in~     the way adolescent transplant recipients take their prescribed medicine.~      Target population: medically stable adolescent solid organ (e.g., heart, kidney, liver, lung,~     small bowel) transplant recipients and their parent(s)/guardian.~   "
51542|NCT02892253|"~     This Randomized Controlled Trial evaluates the clinical impact of parathyroid~     autofluorescence visualization using near infrared light (NIR) during total thyroidectomy~     (TT). It compares patients who undergo TT associated or not with lymph node dissection (LND)~     with NIR vs without NIR use during surgery.~   "
51543|NCT02892240|"~     In 1965, Emile Letournel and Robert Judet reported their experiences on acetabular fractures~     at the 5th day of the Raymond Poincaré Hospital in Garches. Classification Letournel is still~     relevant and in use today.~      Many studies have sought to determine if the treatment had to be surgical or orthopedic.~     Although the standard treatment of displaced fractures of the acetabulum is the reduction and~     osteosynthesis, some advocate the THA in elderly patients with comminuted fracture of the~     acetabulum, impaction of the femoral head or acetabular impaction affecting more than 40% of~     the articular surface and including bearing zone. All these treatments and those supported~     have been studied in the literature.~      However the study of the laying of total hip remote trauma after acetabular fracture~     osteosynthesis or treated conservatively, is not rich in literature. Only a few articles have~     been published in recent years.~      Indeed, a recent review of the literature are nearly 11 series focusing on the results~     remotely hip prostheses for treatment of acetabular fracture. These two prospective series~     with between 21 and 63 patients. All authors report rates well above those reported~     complications for primary arthroplasty, with a revision of rates ranging between 0 and 26.5%.~      Fractures of the acetabulum are covered in our service by one operator using the same release~     technique based on the stiffening. The objective of this study is to determine whether the~     systematic surgical treatment of these patients by an experienced operator reduces the high~     complication rate.~   "
51544|NCT02892227|"~     Our hypothesis: a daily bedside echocardiographic assessment, protocolized, simple and~     reproducible estimation of filling pressures with an evaluation of mitral inflow and the~     inferior vena cava, allow a more reliable estimate of the true blood volume of the patient~     and thus lead to a therapeutic adjustment more suitable.~      This therapeutic adjustment closer to patient's needs would impact fewer readmissions at 30~     days and mortality, less alteration of biological parameters myocardial, kidney and liver.~   "
51545|NCT02892214|"~     The proposed study will evaluate how personality characteristics, cognitive factors and the~     emotional and behavioral responses of patients with provoked vestibulodynia (localized~     provoked vulvodynia) influence the natural history of the syndrome, patients' adherence to~     therapeutic interventions, provoked pain levels, pelvic floor rehabilitation, emotional~     health and sexual functioning.~   "
51546|NCT02892201|"~     This is a phase II study for patients with squamous cell carcinoma of the head and neck who~     have residual disease following definitive therapy with radiation (with or without systemic~     therapy). Patients must be diagnosed with residual disease within 24 weeks of completion of~     radiation therapy. Residual disease must be biopsy proven before the patient can consent to~     the trial, and can be either from lymph nodes in the neck, or from the primary tumor site.~     Prior to beginning study therapy patients are evaluated by an ENT to determine if they have~     disease amenable to surgical resection. Both resectable and unresectable patients will be~     eligible for participation in the study.~   "
51547|NCT02892188|"~     The purpose of this study is to evaluate the follow-up of the osteoporotic patient by a~     physician-pharmacist collaboration.~   "
51548|NCT02892175|"~     The Leonetti law of 22 April 2005 on the rights of patients at end of life provides the~     opportunity for all adults to write advance directives in case she would one day be unable~     to express their will. If this right is enshrined in the hospitalized patient's charter,~     brought to the attention of any patient entering a hospital, the fact remains that only 2.5%~     of the deceased have written advance directives (study National Institute of demographic~     studies published in 2012).~      Moreover, according Régis Aubry, a researcher at the observatory on the end of life, the~     conditions of the end of life are insufficiently discussed with patients and their families~     and can lead to difficult situations conflicting view. Now, thinking about advance directives~     should allow an exchange on the conditions of the end of life desired by patients.~      Sicard report of December 2012 concluded that such legislation is known neither patients nor~     doctors. This is the first obstacle to its use, even if major psychological barriers exist~     both in patients that their doctors.~      It is in this context that Valls government asked MM. Claeys and Leonetti to propose a new~     bill on the subject. The bill provides that advance directives will no longer be valid for 3~     years, but until changed or until the patient's death, and they can be invoked against~     doctors except emergency or illegality. In addition, to complete the bill, the Ministry of~     Health commissioned the National Health Authority (HAS) writing a form of advance directives,~     as well as a doctor's information guide and patient on the subject. The working group is~     chaired by Professor Sicard. Among the recommendations made to physicians (and by extension~     health professionals), the investigators accept that talk of advance directives as often as~     possible and as early as possible, even in the absence of commitment in the short or medium~     term prognosis .~   "
51549|NCT02892162|"~     Use of catheter ablation for persistent atrial fibrillation (PerAF) remains controversial due~     to unsatisfactory long-term success rates (15% - 28.4%). The investigators' previous study~     indicated that the upper area of the left atrium (LA) plays an important role in PerAF, with~     the LA roof and mitral isthmus appearing to serve as main substrate in progression from PAF~     to PerAF and maintenance of fibrillatory activities. The investigators therefore hypothesized~     that AF should not be initiated or sustained if the latter crucial regions for AF maintenance~     are abolished. This study aimed to describe the efficacy and safety of additional linear~     ablation on the left atrial anterior wall for PerAF.~   "
51550|NCT02892149|"~     A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance~     treatment of anemia in subjects with DD-CKD~   "
51551|NCT02892136|"~     This study will explore new ways of using magnetic resonance imaging (MRI) to evaluate~     pediatric patients with cardiovascular disease,congenital heart disease in patients of all~     ages, fetuses undergoing clinically indicated MR imaging.~   "
51552|NCT02892123|"~     To evaluate the maximal tolerated dose (MTD), optimal biological dose (OBD) or other~     recommended dose (RD), and overall safety and tolerability of ZW25 in patients with locally~     advanced (unresectable) and/or metastatic HER2-expressing cancers.~   "
52285|NCT02882555|"~     The hypothesis is that the cough reflex induced by capsaicin is inhibited during exercise.~     The purpose of this study is to determine if a short muscular exercise inhibits the cough~     reflex induced by capsaicin inhalation.~   "
51554|NCT02892097|"~     The purpose of this study is to test the effects of three different rehabilitation training~     sessions that combine non-invasive brain stimulation (transcranial direct current~     stimulation, tDCS) with arm rehabilitation training (repetitive task-specific practice, RTP)~     for individuals with unilateral spatial neglect following stroke. This study is designed to~     determine the effects of tDCS + RTP on the excitability in the brain, attention to the~     affected side, and arm movement ability.~   "
51555|NCT02892084|"~     This project will evaluate two different methods of normalizing the center of mass~     acceleration (COMa) in individuals post-stroke, specifically focusing on rates and pattern of~     recovery to analyze walking-specific adaptations as precursors to motor learning. In~     addition, the proposed project seeks to establish the optimal configuration of electrodes to~     activate neural circuits involved in post-stroke locomotion. Once the better method of~     training COMa and optimal parameters of electrode placement for tDCS are identified, the~     investigators will evaluate the effects of tDCS on locomotor adaptations during single~     sessions and over a five-day training period.~   "
51556|NCT02892071|"~     Tri-split face study of skin resurfacing modalities for the treatment of melasma, comparing~     the medium depth trichloroacetic acid peel, CO2 laser and Qs-NdYag laser.~   "
51557|NCT02892058|"~     The need for a tool to measure flare in lower limb osteoarthritis (OA of the hip and knee) is~     justified by the opportunities for development of clinical trials targeting hip and knee OA~     long-term treatment (slow acting drug, disease modifying drug) and short-term treatment of~     symptoms. Such treatments are currently under development and will likely bring important~     changes in the treatment of patients. The development of a Flare-OA tool would be essential~     to capture the occurrence of flare, and to implement and adapt treatment strategies.~      This project was elaborated with the aims to:~        1. define the construct through development of a conceptual framework~        2. use the conceptual framework to inform the development of a patient-reported outcome~          measure, Flare-OA tool, for people with OA~        3. evaluate the psychometric properties of the new measure using the OMERACT (Outcome~          Measures in Rheumatology) filter 2.0 and Rasch measurement methods.~   "
51558|NCT02892045|"~     A new NMT module from Mindray (Mindray Co. Shenzhen, People's Republic of China.) claims to~     measure 3 directional accelerography. The aim of the study is to compare the neuromuscular~     block of rocuronium 0.6 mg/kg (twice the 95% effective dose, ED95) monitored by the NMT~     versus that monitored by the Relaxometer Mechanomyograph on the other hand in Group 1, and~     versus the TOF-Watch on the other hand in Group 2 to clinically evaluate the new system for~     its diagnostic accuracy.~   "
51559|NCT02892032|"~     This study aims to examine the effects of smartphone-based Attention-Bias Modification~     Training (ABMT) in chronic pain participants.~   "
51560|NCT02892019|"~     This study is designed to explore lung function effects of two doses of indacaterol acetate,~     75 μg and 150 μg, in pediatric asthma patients 6-11 years old, and to compare the systemic~     exposure to indacaterol in plasma with historical data in adults, to identify an appropriate~     dose to Phase III evaluation.~   "
51561|NCT02892006|"~     Managing distress and improving well-being is critically important for optimal survivorship~     care. Treatment of distress leads to better adherence to treatment, better communication,~     fewer calls and visits to the oncologist's office, and avoidance of development of severe~     anxiety or depression. Based on national guidelines, distress is typically managed with~     pharmacologic options (i.e. benzodiazepines), support groups, individual counseling, or~     chaplaincy services. To our knowledge, the role of a structured improvisational comedy~     (improv) program in reducing distress and improving well-being has never been evaluated in~     the oncology setting.~   "
51562|NCT02891993|"~     The purpose of this research study is to address the challenge of symptom management for~     hospitalized patients with cancer.~   "
51563|NCT02891980|"~     This is a Phase 1, double-blind, randomized trial to evaluate the safety and immunogenicity~     of two heterologous and two homologous prime-boost regimens using MVA-BN®-Filo and Ad26.ZEBOV~     administered in different sequences at Days 1 and 29 in healthy adult subjects aged 18 - 45~     years.The study will evaluate the 'omics (transcriptomics, proteomics, lipidomics,~     metabolomics), antibodies for immunogenicity, CMI, ADCC, lymphoproliferative and plasmablast~     responses to MVA-BN®-Filo and Ad26.ZEBOV vaccines. The primary objectives of this study are:~     1) To Assess the safety and reactogenicity of each study group. 2) To assess responses to the~     study vaccination by study group after the first, second and third dose by transcriptomics.~     3) To assess the peak antibody response to the study vaccination by study group to filovirus~     antigens.~   "
51564|NCT02891967|"~     restoring posterior teeth by bulk fll and nanofill composite and clinical evaluation of~     performance and durability of both restorations during one year follow up~   "
51565|NCT02891954|"~     Five daily doses of canagliflozin (300 mg) will be administered to healthy volunteers.~     Pharmacodynamic responses to canagliflozin will be assessed both at 2 days and 6 days after~     administration of the first dose of canagliflozin. A genome-wide association study (GWAS)~     will be conducted to search for genetic variants that are associated with each of the~     pharmacodynamic responses to canagliflozin.~   "
51566|NCT02891941|"~     This exploratory study aims to identify the most promising biomarkers that alone or in~     combination might predict development of mood disorders [i.e., major depression (MD],~     cognitive disorders [i.e., executive function deficits (EFD)], and functional impairment~     following repetitive/mild traumatic brain injury (MTBI).~   "
51567|NCT02891928|"~     The purpose of this study is to determine if the wearing of shoes rocker sole type~     prescribed in type 2 diabetics patients with neuropathy are responsible for disorders of~     equilibrium.~   "
51568|NCT02891915|"~     This is a multi-center, randomized, double-blind, placebo-controlled, superiority clinical~     trial will test the effectiveness of short (5-day) vs.standard (10-day) course therapy in~     children who are diagnosed with CAP and initially treated in outpatient clinics, urgent care~     facilities, and emergency departments. Primary objective is to compare the composite overall~     outcome (Desirability of Outcome Ranking, DOOR) among children 6-71 months of age with CAP~     assigned to a strategy of short course (5 days) vs standard course (10 days) outpatient~     beta-lactam therapy at Outcome Assessment Visit #1 (Study Day 8 +/- 2 days)~   "
52563|NCT02878928|"~     A prospective, multi-center, randomized, subject and outcome evaluator blind , parallel-group~     study evaluating the effect of pharmacogenetic-guided versus standard of care treatment for~     subjects diagnosed with depression and/or anxiety disorders.~   "
51569|NCT02891902|"~     The purpose of this study is to evaluate in a multicentric cluster randomized study the~     effect of the presence of dedicated nurses for training of ICU staff in preventing nosocomial~     infections. The rate of bloodstream infections per 100 admitted patients is used as the main~     endpoint. A sample of 4000 included patients in the 6 participating ICU is included with the~     objective to show a reduction of one third of the rate of ICU-acquired bloodstream~     infections. The study is currently at the end of the recrutimeent phase.~   "
51570|NCT02891889|"~     The aim of this study is to investigate aspects of brown fat in scanner with injection via~     the PET-CT study.~   "
51571|NCT02891876|"~     Biodentine® is a most recent material for direct pulp capping. The aim of this study is to~     determine the 3 months success rate (defined as clinical and radiographic successes together)~     of direct pulp capping realized with Biodentine®.~   "
51572|NCT02891863|"~     The LEVER study is a prospective, unblinded, non-randomized, first in human feasibility study~     that will assess and characterize early safety and effectiveness of low energy therapies in~     converting monomorphic ventricular tachycardias (MVTs).~   "
51573|NCT02891850|"~     To demonstrate the effectiveness of riociguat as replacement of phosphodiesterase-5~     inhibitors (PDE-5i) therapy in pulmonary arterial hypertension (PAH) patients~   "
51574|NCT02891837|"~     The purpose of this study is to determine whether L-citrulline is effective and safe in the~     prevention of clinical sequelae of Acute Lung Injury in pediatric subjects undergoing surgery~     for congenital heart defects.~   "
51575|NCT02891824|"~     This is a phase III, randomized, double-blinded, comparative, multi-centre study to assess~     the efficacy of atezolizumab in combination with platinum-based chemotherapy plus bevacizumab~     administered concurrent to chemotherapy and in maintenance, in patients presenting epithelial~     ovarian cancer (including patients with primary peritoneal and / or fallopian tube~     adenocarcinoma) who have platinum-sensitive relapse (platinum-free interval > 6 months).~   "
51576|NCT02891811|"~     This is a randomized, 2-arm phase II, multi-center study to evaluate the overall response~     rate in newly diagnosed, transplant ineligible patients receiving 9 cycles induction therapy~     with either KTd or KRd followed by randomization to either carfilzomib maintenance treatment~     for 12 months or to observation only. Maintenance is given for 12 cycles or progression of~     disease, whatever occurs first.~   "
51577|NCT02891798|"~     After total joint replacement, early hospital discharge to home (with patients capable of~     continuing a home-based rehabilitation program) is a cost- effective management strategy.~     This project will use improved local anesthetic nerve block techniques to enhance technical~     capability and clinical practice by (i) reducing pain and other morbidities during recovery,~     (ii) improving weight-bearing achievement during in-hospital physical therapy to allow for~     earlier return home, and (iii) continued rehabilitation as an outpatient at home when~     feasible (versus in an extended care facility).~   "
51578|NCT02891785|"~     Background: Significant barriers to cancer pain management are patient-related. So far,~     cancer pain self-management support interventions have only been tested in strictly~     controlled settings of randomized controlled trials (RCT) and thus evidence for comparative~     effectiveness is lacking.~      Methods: This study includes a multicenter cluster RCT with a stepped wedge design and a~     qualitative substudy. The aim of the study is to evaluate the implementation of ANtiPain in~     clinical practice. The primary patient-related aim is to improve pain interference with daily~     activities. Secondary patient-related aims are pain intensity, barriers to pain management,~     self-efficacy, and quality of life. Secondary organization-related aims are nurse proficiency~     and satisfaction with cancer pain self-management support, participation rates, and~     implementation fidelity.~      Inclusion and exclusion criteria: On 17 wards in 3 hospitals in Vienna adult oncology~     patients will be included (n=150 pre-, n=150 post-implementation) if they are admitted to one~     of the participating wards, have pain ≥3 (0=no pain to 10=worst imaginable pain) or regular~     pain medication, able to understand German, discharged with pain self-management, and give~     informed consent. Patients with signs of disorientation that may severely limit pain~     self-management will be excluded.~      Interventions: Pre-implementation, patients receive standard care. Post-implementation,~     patients receive ANtiPain which is based on 3 key strategies: information, skills building~     and nurse coaching and consists of in-hospital sessions by staff nurses and follow-up phone~     calls after discharge. The implementation process will include training of the designated~     staff nurses, case discussions, as well as measures to ensure sustainability of the~     implementation (e.g., training of clinical nurse specialists).~      Procedures: Wards are randomized according to the stepped wedge plan. Patients will complete~     questionnaires at admission, and 2, 4 and 8 weeks after discharge. Nurse-level data will be~     collected before implementation and 1 and 3 months after implementation. Data on ward and~     hospital level will be collected at the beginning of the study.~      Statistical analysis: The statistical analysis will be conducted based on mixed models, with~     a random intercept for the respective ward and time as a covariate.~      Qualitative substudy: The qualitative substudy will comprise interviews with head and~     intervention nurses about their views of the implementation.~   "
51579|NCT02891772|"~     Hypotension often happens immediately after anesthetic induction. Particularly in 5-10~     minutes after anesthetic induction it is reported to happen more frequently. Patients may~     have preexisting hypovolemia resulting from dehydration and impaired compensatory responses,~     which increase the risk. However, it is still challenging to assess intravascular volume~     status in spontaneously breathing patients before anesthetic induction. Recently, the~     measurement of corrected flow time in carotid artery was introduced as quite useful, simple~     and noninvasive for the evaluation of circulating blood volume. The aim of this study is to~     evaluate whether corrected carotid artery flow time as determined by ultrasonography in~     spontaneously breathing patients before general anesthesia can predict hypotension after~     induction.~   "
51580|NCT02891759|"~     This study will evaluate the performance of Alloderm RTU medium (LifeCell) vs. Cortiva 1mm~     Allograft Dermis (RTI Surgical®, Inc.). These are the thinnest versions of acellular dermal~     matrices (ADM) offered by both vendors and can be used for post-mastectomy breast~     reconstruction. Alloderm RTU medium has a thickness of 1.6±0.4 mm, while Cortiva 1mm~     Allograft Dermis has a thickness of 1.0±0.2 mm. In the context of breast reconstruction,~     these ADMs are used in the same manner. They may be inserted with a tissue expander~     immediately after skin- or nipple-sparing mastectomy. The investigators will examine~     breast-reconstruction associated complication rates, pre- and post-operative patient reported~     outcomes using the Breast Q, and physician reimbursement as well as direct hospital costs.~     The endpoint will be either exchange of the tissue expander for a permanent breast implant or~     autologous flap, explantation due to patient preference, development of a complication, or~     less common reasons. The investigators propose that Cortiva 1mm Allograft Dermis and Alloderm~     RTU will have equivalent complication and patient reported outcome rates as well as physician~     reimbursement, but that direct hospital cost will be less with Cortiva 1mm Allograft Dermis.~   "
51683|NCT02890420|"~     This study permit to evaluate the characteristics of children in third year of preschool,~     during a year, in 16 schools in Thionville (north-eastern France) by the way of the annual~     medical visit.The aim of the study is to describe the nutritional status of children~     under-six years of age: underweight, overweight, and obesity considering the sex. .~   "
51581|NCT02891746|"~     The aim of the study is to characterize and monitor the microbiome of premature infants born~     in the investigators facility until discharge from the NICU. The investigators will also~     examine the relationship between mode of delivery and the microbiome of the infant, while~     exploring various possible factors that may affect it. In addition, the investigators will~     compare the microbiome of premature infants to the microbiome of term babies born at the same~     time in the same facility.~   "
51582|NCT02891733|"~     Lung cancer is the leading cause of cancer mortality in France and worldwide. 60% of patients~     present themselves with a disease diagnosis immediately metastatic non curable.~     Adenocarcinomas account for 50% of incident tumors. Treatment is based on the platinum-based~     chemotherapy with or without maintenance therapy. When there is to exhaust this first line, a~     second line treatment is offered to the patient. Three drugs are allowed in this situation:~     docetaxel, erlotinib (inhibitor of the tyrosine kinase activity of the receptor for epidermal~     growth factor - TKI-EGFR) and pemetrexed (which in fact has become virtually standard in~     first online and in combination with platinum in all patients with non-squamous cancer, so~     that his place is in second line reduced facto). There is no recommendation for treatment in~     third line situation where only erlotinib is allowed.~      Most recently, the nivolumab, anti-PD1 monoclonal antibody (which aims to enable immunutaire~     system) saw its demonstrated effectiveness in the second line and beyond in the two Phase 3~     trials where it was compared with docetaxel for the treatment of squamous cell carcinoma and~     non-squamous. The very recent availability in France of the drug under an ATU fact that it~     will most likely become a standard second line, which will tend to place the third line~     docetaxel.~      Therefore, erlotinib will be in 4th line situation. However, in the absence of an EGFR~     mutation (which is only seen in more than 10% of Caucasian patients) use of the drug does not~     seem appropriate or even harmful. A selection of patients likely to benefit from the~     prescription of EGFR TKI-is essential.~      Neurotensin (NTS) is a polypeptide of 13 amino acids present and active in the central~     nervous system and the periphery. At the peripheral level, neurotensin is secreted~     postprandial by endocrine cells in the intestinal mucosa and is involved in the motor~     functions of the gastrointestinal tract. The effects of neurotensin pass through the~     activation of three subtypes of receptors which, mainly, NTSR1 and NTSR2 which are receptors~     coupled to G proteins in the extra-digestive normal tissues, including lung, torque NTS /~     NTSR1 n is not expressed physiologically. Rather, this complex is likely to recur in tumor~     tissues.~      The mechanism of this effect is derogatory activation torque NTS / NTSR1 of matrix~     metalloproteinases which causes the release by the cell membrane ligands EGF-like and thus,~     activation of HER receptor (EGFR or HER1, HER2 and HER3). Indeed, in experimental tumors~     created by subcutaneous injection in athymic mouse cell lines adenocarcinomas NTS + / NTSR1 +~     (non-mutated EGFR), treatment with erlotinib - which blocks EGFR pathway - causes a~     significant decrease of tumor growth.~      Expression of the neurotensin receptor in cancer cells metastatic primary bronchial~     adenocarcinoma is not known. Therefore, its pejorative prognostic value is not confirmed in~     the metastatic setting.~   "
51583|NCT02891720|"~     The goal of this study is to evaluate an integrated technology system that confirms ingestion~     of oral PrEP, monitors adherence both in real-time and longitudinally, and provides visual~     feedback mechanisms to promote enhanced adherence behaviors.~   "
51584|NCT02891707|"~     This joint research project between the Department of Veterans Affairs (VA) and Department of~     Defense (DoD) will demonstrate that the implementation of the Mobile Device Outcomes-based~     Rehabilitation Program (MDORP) will improve the quality of rehabilitative care at a decreased~     cost to the healthcare system and a reduced burden for service members (SMs) and veterans~     with lower limb loss. The development of the MDORP will be executed by a multisite~     translational clinical care team that will use web-based mobile computing devices designed to~     assess mobility, enable remote prescription of targeted exercise program, and provide~     continual measureable outcomes to document the continuum of care with the intent of~     maximizing prosthetic performance while minimizing adverse medical events. The information~     obtained from this web-based mobile device application will be used by clinicians to promote~     continuity of care from the DoD and VA facilities nationwide to the community and at home.~   "
51585|NCT02891694|"~     Recurrent corneal erosion (RCE) syndrome can be observed either in the context of a dystrophy~     of the basement membrane or following corneal trauma. This syndrome is characterized by~     recurrent episodes of ocular pain more or less associated with localized separations between~     the outer epithelium and the epithelial basal lamina (basement membrane) because of anchorage~     abnormalities between these two corneal layers. This could be the result of an increased~     expression of metalloproteinases cleaving the hemidesmosomes which anchor epithelium to the~     basement membrane.~      The investigators hypothesis is that episodes of RCEs are favored by a hyper- expression of~     matricial metalloprotease 9 (MMP-9) induced by EMMPRIN and Galectin-3. The identification of~     such induction could lead to development of therapeutics inhibiting EMMPRIN and Galectin- 3~     in the RCE syndrome.~   "
51586|NCT02891681|"~     To determine the accuracy of NIR/US assessment of tumor vasculature and oxygen changes in~     predicting and monitoring early neoadjuvant treatment response compared to pathological~     response.~   "
51587|NCT02891668|"~     This project has the following primary aims:~      The main objective is to delineate the association between changes in Resting energy~     expenditure (REE) and QOL in hypothyroid patients before and after one year of L-T4~     treatment. To achieve this, the investigators plan to compare newly diagnosed hypothyroid~     patients soon after diagnosis before L-T4 therapy has been initiated after 6 months and after~     1 year of treatment.~      Primary endpoint is changes in REE compared to changes in QOL Secondary endpoint is changes~     in cognitive function and changes in body composition before and after one year of treatment~     and furthermore changes in insulin resistance following changes in body composition and free~     fatty acids (FFA).~   "
51588|NCT02891655|"~     Corneal stromal thinning observed in keratoconic eyes could result from an increased~     synthesis of MMP at the level of the anterior stroma and the corneal epithelium induced by an~     overexpression of the Extracellular Matrix Metalloproteinase Inducer (EMMPRIN) and Galectin-3~     by epithelial cells. A differential expression of EMMPRIN, Galectin-3 and metalloproteinases~     (MMP) may be observed between the apex of the keratoconus and the peripheral cornea.~     Highlighting the implication of EMMPRIN and Galectin-3 could lead to the development of~     specific inhibitors to slow or to stop keratoconus evolution.~   "
51589|NCT02891642|"~     The purpose of the current study is to establish a Liquid biopsy method (positive enrichment~     by a novel immunomagnetic beads capture assay) for detection of malignant cell in serous~     effusions and to evaluate its sensitivity and specificity for clinical application.~   "
51590|NCT02891629|"~     The EyeControl device is an eye movement-based communication device in the form of wearable~     glasses with connected infrared cam-era that tracks the pupil and translates blinks and~     movements into commands.This study is aimed to demonstrate the safety and feasibility of the~     EyeControl device in healthy volunteers, and ALS patients in early stages.~   "
51591|NCT02891616|"~     In the current study, advanced positron emission tomography/computed tomography (PET/CT) and~     positron emission tomography/magnetic resonance (PET/MR) imaging methods will be used to~     validate our hypothesis that melanoma patients receiving Dual-Immune Checkpoint Blockade~     (DICB) therapy, who ultimately achieve clinical benefit, will have an increase, or FLARE,~     in tumor FLT and/or FDG uptake from baseline, as seen after cycle#1 of treatment, and that~     after 2 cycles of treatment responders will have a decline in FLT and FDG uptake, in~     comparison to the patients classified as non-responders. In addition, alterations in tumor~     apparent diffusion coefficient (ADC) on diffusion-weighted magnetic resonance imaging~     (DW/MRI) will be evaluated, expecting after cycle#1: transient reductions in ADC due to~     lymphocyte proliferation, increased cellularity and restriction of water movement in~     responding patients, with these patients tumors having increased ADC at 2 cycles into therapy~     associated with tumor necrosis. This study will evaluate rather early PET imaging with FLT~     and FDG is a useful imaging biomarker of response to DICB.~   "
51592|NCT02891603|"~     The purpose of this study is to examine a new approach to preventing a serious problem after~     transplant called graft vs. host disease (abbreviated as GVHD).~      This is a single-arm, phase I/II, study of Pacritinib with Sirolimus and Tacrolimus~     (PAC/SIR/TAC) for the prevention of acute GVHD after matched related and unrelated allogeneic~     hematopoietic cell transplantation (alloHCT).~   "
51593|NCT02891590|"~     The Primary Objective is to evaluate the safety and tolerability of multiple dose oral~     administration of DTRMWXHS-12 capsule in patients with B-cell lymphoma.~      The Secondary Objective is to evaluate the pharmacokinetics of multiple dose oral~     administration of DTRMWXHS-12 capsule in patients with B-cell lymphoma.~   "
51594|NCT02891577|"~     This study aims to describe the ratio of the diameter of inferior vena cava to the common~     femoral vein measured by ultrasonography in critically ill patients with shock, and to~     evaluate the potential link between this ratio and the existence of intra-abdominal disease.~   "
51595|NCT02891564|"~     Project:EVO is a video-game based intervention that targets neural networks associated with~     cognitive control. The same networks have been implicated in poor treatment response in~     middle and older aged adults suffering from major depression. Related work has demonstrated~     that healthy older adults show significant improvement in cognitive control. In a very small~     sample of older adults suffering from depression (n=12), we found similar improvements in~     selective attention and working memory after 4 weeks of intervention, along with improvements~     in mood comparable to participants receiving an evidence-based psychotherapy. The intent of~     this proposal is to first determine if at least 2/3 of participants who use Project:EVO for~     four weeks demonstrate significant improvements in the function of these neural networks, and~     if improvements are observed, to conduct a second study to see if changes in neural network~     functions are associated with changes in mood. If we show that Project:EVO improves neural~     function and mood to a greater degree than a placebo cognitive training game, we will be in a~     position to move onto the next phase of study, which is to demonstrate the intervention's~     efficacy in a much larger sample of adults with depression.~   "
51596|NCT02891551|"~     The study design is a prospective, non-interventional, observational single arm study.~      A minimum of 150 patients will be recruited from approximately 30 haematology/oncology sites~     in the Netherlands. In all cases, the decision to treat the patient with azacitidine was~     already made prior to the decision to enter the subject into the study.~      Recruitment will continue until end of June 2015, provided a minimum of 150 patients have~     been included in the study. When this date is reached, all patients on azacitidine will~     continue to be followed until the last patient enrolled has been followed for 12 months.~   "
51597|NCT02891538|"~     This will be a randomized, controlled pilot trial of patients with histological documentation~     of primary colon or rectal adenocarcinoma with resectable cancer, who have not received any~     treatments for cancer. If patient is a candidate for surgical resection, with no planned~     neoadjuvant chemotherapy, then the patient is eligible. All eligible subjects will be~     consented prior to surgery.~   "
51598|NCT02891525|"~     In this study, the investigators aimed at evaluating the role of sweet taste receptors in the~     gastrointestinal tract (GIT). Intragastric administration of glucose, fructose or~     acesulfame-K were compared with placebo administration for their effects on gastrointestinal~     motility, gut hormone release (motilin, ghrelin, glucagon-like peptide-1 (GLP-1) and insulin)~     and hunger feelings.~   "
51599|NCT02891512|"~     The purpose of the study is to determine the effectiveness of the treatment with very low~     frequency magnetic fields (ELF) on the reduction of pain and the relief of the associated~     signs such as sensitivity disorders that affect the first three fingers and half of the~     fourth finger of the hand in patients with carpal tunnel syndrome versus the supplement (=~     Xinepa).~   "
51600|NCT02891499|"~     The purpose of this study is to evaluate the effect of Low level laser therapy on stability~     and displacement of orthodontic miniscrew implants using two different force application~     protocols.~   "
51601|NCT02891486|"~     Post-operative wound infections can prolong hospital stays, increase rates of readmission to~     the intensive care unit, and increase the costs of treatment significantly. This study will~     conduct a prospective chart review of all patients undergoing elective spinal surgery on both~     the neurosurgery and orthopedic spine services at two facilities on an academic campus. The~     investigators will collect the data of those patients who develop post-surgical infections.~     This data will then be analyzed and compared to published data from other studies. The aim of~     this investigation is to passively collect this infection data, which may ultimately provide~     needed baseline incidence rates using current and standard protocols.~   "
51602|NCT02891473|"~     The purpose of the study is to evaluate the effectiveness of a rehabilitative approach using~     breathing and relaxation techniques, and specifically the elongation of the latissimus dorsi~     muscle according to the Mézières Method to improve balance and posture and relief pain in~     patients with Parkinson's disease.~   "
51603|NCT02891460|"~     The purpose of this study is to evaluate the clinical response of the tumors within the~     bladder of recurrent NMIBC patients to Mitomycin-C embedded in UroGen Pharma's (known at that~     time as TheraCoat Ltd.) TC-3 Sterile Hydrogel (TC-3) and to evaluate the patency of ureters 6~     hr post instillation.~   "
51604|NCT02891447|"~     The goal of this clinical research study is to learn whether cytoreduction surgery (surgery~     to reduce or remove lesions), gastrectomy (where all or part of the stomach is removed), and~     hyperthermic intraperitoneal chemoperfusion (HIPEC, a heated chemotherapy treatment delivered~     directly inside the abdomen during surgery) can help control the disease in patients with~     gastric and/or gastroesophageal cancer. The safety of these procedures will also be studied.~   "
51605|NCT02891434|"~     The task consists in reach as much bubbles as they can, the bubbles appear on the screen of~     the computer and should be reached in 10 seconds. To accomplish that, three different devices~     will be used: (1) Kinect for Windows Microsoft - which consists of a sensor that captures~     body movements (including upper limbs). And (2) the Leap Motion (LMCH, Leap Motion, Inc., San~     Francisco, CA, USA), and (3) Touch Screen. To describe motor impairments was used the Motor~     Function Measure Scale; Scale Vignos and Scale Egen Klassifikation;~   "
51606|NCT02891421|"~     The project partnered with U.S. military veterans with a premier accredited therapeutic~     riding center for six weeks. The veterans interacted with horses by grooming and learning~     about them, as well as riding them for one hour per week during which they gained a variety~     of skills. We hoped the veterans would experience a reduction in Post Traumatic Stress~     Disorder (PTSD) symptoms, depression, and loneliness, while improving their social and~     emotional health and self-efficacy.~   "
51607|NCT02891408|"~     The primary objective of this study is to evaluate the single-dose pharmacokinetics (PK) of~     GS-0976 in adults with normal hepatic function, and mild, moderate, or severe hepatic~     impairment.~   "
51608|NCT02891395|"~     Open label non-randomized multicenter phase 2 trial with direct individual benefice~   "
51631|NCT02891096|"~     The investigators conducting this study to investigate the relation between the respiratory~     muscle strength and respiratory complications. To understand more about respiratory~     complications the influence of different factors (such as in- and expiratory muscle strength,~     lung function parameters, physical activity, smoking, medications,…) on respiratory~     complications (such as pneumonia) will be investigated.~   "
51609|NCT02891382|"~     This feasibility study aims to compare the implementation process of three different~     interventions that use economic incentives to promote lifestyle behavioral changes in~     patients with type 2 diabetes mellitus, and to identify barriers and facilitators linked to~     the process of implementing each of the interventions. The interventions are based on~     economic incentives directed to the patient (individual incentives) or a team comprised by~     the patient and a partner (mixed incentives).~      Design: Three-month randomized control feasibility study to test the feasibility of~     implementing three types of intervention with economic incentives in patients with diabetes~     mellitus.~      Setting: Diabetes outpatient clinics from a public hospital in Peru.~   "
51610|NCT02891369|"~     The refractory malignant ascites is a complication of advanced stages of many cancer types.~     It is characterized clinically by abdominal pressure sensation, shortness of breath and~     pelvic pain. Thus, it contributes to decreased quality of life for these patients in~     palliative care.~      Conventional treatment is based on paracentesis of ascites. The progression of the disease~     leads to increased production of ascites requiring more frequent paracentesis. Main~     therapeutic alternatives are constituted by the controversial use of diuretics and the use of~     an antibody inhibiting the activity of the Vascular Endothelial Growth Factor (VEGF):~     bevacizumab. Catumaxomab, a monoclonal antibody anti-EpCAM and CD3, developed for the~     treatment of refractory malignant ascites showed no sufficient clinical benefit.~      VEGF is overexpressed in many tumors. VEGF causes an increase in capillary permeability and~     capillary filtration surface generating increased protein extravasation. These phenomena are~     responsible for an increase of the volume of ascites product. Thus the use of inhibitors of~     VEGF, such as bevacizumab, could reduce the production of ascites.~      The efficacy of bevacizumab to decrease the volume of ascites product was demonstrated on~     small animals in intraperitoneal administration.~      Studies in humans are few and the doses used are not consistent from one study to another.~   "
51611|NCT02891356|"~     The mechanism of bone loss in anorexia nervosa is complex. Marrow adipose tissue seems to~     play a role in the regulation of bone metabolism. Adipocytes secrete cytokines and adipokines~     that either stimulate or inhibit adjacent osteoblasts. This study consist to explore the~     relationship in anorexia nervosa patients with change in bone mineral density and adipokines~     like leptin, adiponectin and Préf-1 Bone mineral densities will be measure in 180 anorexia~     nervosa patients at inclusion and every two years during 6 years.It is assessed blood and~     urinary calcium and phosphate levels, bone remodelling markers and adipokines (leptin,~     adiponectin and Préf-1)~   "
51612|NCT02891343|"~     The early assessment of new symptomatic drugs for Alzheimer disease remains difficult because~     of the lack of predictive end-point. The use of a battery including different parameters~     could improve this early development. In healthy volunteers, to test the reverse effect of~     symptomatic drugs, it is necessary to induce transient and reversible cognitive impairment~     and cerebral activity changes by a challenge test. In this context, a transient hypoxia could~     be relevant.~   "
51613|NCT02891330|"~     The postprandial dumping syndrome is a frequent consequence of Roux-en-Y Gastric ByPass due~     to the rapid emptying of the stomach remnant in to the intestinal lumen. Dumping-related~     symptoms occur very early after eating (within 30 minutes), are not associated with~     concurrent hypoglycemia, and are most prominent in the early postoperative period. This~     syndrome very debilitating for the patient can be improved by dietary and nutritional~     recommendations. We hypothesize that a personalized approach based on dietary and nutritional~     recommendations conducted by a nurse would likely to decrease the frequency of dumping~     syndrome and improve the postoperative quality of life of patients in the early postoperative~     period.~   "
51614|NCT02891317|"~     The purpose of this study is to assess how surgical interventions in glaucoma affect 24-hour~     intraocular pressure, 24-hour ocular perfusion pressure, optic nerve blood flow, and retinal~     oxygen saturation.~   "
51615|NCT02891304|"~     Hypothesis: ACE (The Assessment in Competency in Endoscopy Tool) tool for colonoscopy and EGD~     (Esophagogastroduodenoscopy) allows for reliable standardized learning curves, competency~     benchmarks, and creation of a centralized database that compares trainee performance amongst~     peers. Trainees receiving quarterly learning curves achieve competence in endoscopic~     procedures at a faster rate (ie less procedures) compared to trainees receiving usual~     feedback on endoscopic performance as established by their respective GI (gastrointestinal)~     fellowship program.~      Aims: To compare the number of procedures necessary to achieve competence in EGD and~     colonoscopy between trainees receiving learning curve performance feedback every three months~     in addition to standard feedback versus trainees receiving annual learning curve performance~     feedback in addition to standard feedback for these endoscopic procedures. To demonstrate the~     feasibility of development and adoption of a centralized database that would allow program~     directors and general GI trainees to generate performance reports in relation to national~     peers to provide real-time targeted performance feedback during training and evaluate trainee~     and GI fellowship program directors predictors of competence.~   "
51616|NCT02891291|"~     Optical coherence tomography is technology widely used in medicine. In this study, the~     investigators will use an optical tomographic scanner to scan skin tissue image.~   "
51617|NCT02891278|"~     This is a Phase I study with the goals of determining the feasibility, safety, and toxicity~     of administering sertraline in combination with timed-sequential cytosine arabinoside (ara-C)~     in adults with relapsed and refractory acute myeloid leukemia.~      Primary objective:~        -  To define the maximum tolerated dose (MTD) and Recommended Phase II Dose (RP2D) of~          sertraline administered in combination with timed-sequential cytosine arabinoside in~          adult patients with relapsed and refractory acute myeloid leukemia.~        -  To evaluate the safety and tolerability of sertraline given in combination with~          timed-sequential cytosine arabinoside in adult patients with relapsed and refractory~          acute myeloid leukemia.~   "
51660|NCT02890719|"~     Pilot, single center, open-label study to evaluate the efficacy and tolerability of~     Grazoprevir and Elbasvir in HCV GT1 and 4 liver transplant recipients.30 liver transplant~     recipients with hepatitis C recurrence.~   "
51661|NCT02890706|"~     Comparing two techniques (Subtraction and Dual Energy CT) for functional Chest CT for~     patients with suspected with pulmonary embolism.~   "
53289|NCT02869425|"~     This study is designed to assess the effects of a therapeutic dose of arbaclofen extended~     release (ER) tablets compared with placebo on human sperm concentration, motility, and~     morphology in male subjects with multiple sclerosis (MS).~   "
51618|NCT02891265|"~     Tobacco use is the leading preventable cause of death contributing to more than 5 million~     estimated deaths per year globally. The longterm negative effects of smoking are well~     established. Complications due to smoking, from an orthopaedic perspective include impair~     bone and wound healing, and increased risk of infection and osteomyelitis.~      The primary outcome of this research is smoking cessation in patients attending the~     orthopaedic fracture clinic. This is a unique environment whereby previously healthy patients~     are faced with the impact of disability. This impetus to abstain from the benefit of fracture~     outcomes provides an opportunity for previously unattained early intervention and thus a~     greater potential for decreased patient morbidity and mortality. Furthermore it is a high~     volume clinic that, given the unique nature of traumatic injuries consists of a high~     proportion of males, ages 24-34 years old, obliged to follow up. This population is~     traditionally regarded as unattainable from primary prevention smoking cessation strategies.~     The investigators hypothesize that The Ottawa Hospital Fracture Clinic will serve as an~     effective environment to employ established primary prevention smoking cessation~     interventions, reducing the incidence of complications associated with fracture and surgical~     healing, and result in greater long-term cessation rates.~   "
51619|NCT02891252|"~     hemithyroidectomy as a outpatient procedure is performed in some countries, it has never been~     done a RCT whether it is feasible~   "
51620|NCT02891239|"~     This is an open-label, multi-center study. Subjects in this study will receive up to eight~     (8) treatments in 11±5 weeks (6-16 weeks) interval, with the PicoWay device using the 785 nm~     wavelength alone or combined with 1064 nm or 532 nm wavelengths. Subjects will return for one~     follow‐up (FU) visit at the clinic at 8 weeks following the last treatment.~   "
51621|NCT02891226|"~     The purpose of this study is to evaluate the safety and effectiveness of the study drug~     Mirikizumab in participants with active Crohn's Disease.~   "
51622|NCT02891213|"~     Systemic Lupus Erythematosus (SLE) is the most common systemic autoimmune disease. The~     clinical manifestations are severe and affect multiple target organs such as the kidney,~     central nervous system, skin, heart and joints. Despite the progress made in the therapeutic~     approach with new immunosuppressive regimens, morbi-mortality is still high. Therefore, it's~     important to identify new biomarkers to help clinicians to predict severity and evolution of~     the disease for better adaptation of treatments and try to improve the prognosis.~      RAGE (Receptor for Advanced Glycation Endproducts) :~      RAGE (Receptor for Advanced Glycation Endproducts) is an ubiquitous membrane receptor,~     involved in development of many diseases such as diabetes, chronic renal failure but also in~     vascular remodelling, inflammatory, infectious deseases and cancer. RAGE regulates a number~     of crucial cell processes like inflammation, and tissue and cellular homeostasis.~      RAGE is able to bind not only the advanced glycation end products (AGEs) such as pentosidine,~     carboxymethyllysine (CML), methyl-glyoxal-hydroimidazolone-1 (MG- H1), but also other ligands~     such as HMGB1 (high mobility group box1), and S100A8/A9 proteins which have been correlated~     in recent studies to the activity index of SLE. The activation of RAGE leads to a cascade of~     intracellular signaling and activation of the transcription factor NF-ΚB . NF-ΚB enable the~     traduction of proinflammatory cytokines such as IL-6, IL-1α ,IFN-γ. In SLE, these cytokines~     involved in perpetuation of inflammation and tissue damages including lupus nephritis.~     Moreover, the activation of RAGE induces the expression of adhesion molecule such as sICAM -1~     and sVCAM -1 wich were recently involved in SLE vasculitis.~      Soluble forms of RAGE, sRAGE and esRAGE :~      RAGE is a proinflammatory membrane receptor. But RAGE also exists in soluble plasma forms,~     esRAGE (secreted form) and sRAGE (a truncated form as cleaved by MMP9 and ADAM10 enzymes).~     esRAGE and sRAGE have the same ligand-binding specificity as RAGE and may function as a~     'decoy receptor' by binding pro-inflammatory ligands and preventing them from accessing cell~     surface RAGE (Kierdorf and Fritz, 2013). Therefore, both soluble forms have an~     anti-inflammatory action. Several studies have shown a decrease in circulating levels of~     sRAGE in patients with Rheumatoid Arthritis, or Sjögren Syndrome compared with healthy~     controls. However, the role of RAGE in SLE remains unknown.~      RAGE and Systemic Lupus Erythematosus, recent advances :~      Our team (Laboratory of Nephrology, CNRS UMR 7369, URCA) showed in a study in lupus RAGE~     knockout mice (B6/ MRL-FAS lpr/J RAGE-/-) a strong involvement of RAGE in systemic~     manifestations SLE. Recently, another report showed that sRAGE has an anti-inflammatory~     effect on the lupus nephritis and could be a potent therapy in mice.~      In humans, two studies show a correlation between the plasma level of sRAGE and lupus~     phenotype ( Nienhuis et al. , 2008).~      Working hypothesis :~      Based on the results and those of the current studies, the investigators think that RAGE axis~     and its soluble forms play a crucial role in the complex pathogenesis of SLE.~      The investigators hypothesize that plasma levels sRAGE and esRAGE are a reflection of the~     activity and the development of SLE in humans. Soluble forms of RAGE and ligands may be novel~     biomarkers of SLE and sRAGE a potent therapeutic target.~   "
51623|NCT02891200|"~     The study is to compare the effectiveness of two health communication and dissemination~     strategies that are designed to engage patients and family caregivers in successfully~     managing COPD in 'real-world' settings. Both strategies aim to advance patient understanding~     of COPD, its treatment options, and self-care tasks; support them in coping with the disease;~     and enable them to adopt a variety of positive behaviors, including adherence to treatment~     plans, smoking cessation, joining pulmonary rehabilitation programs, and assuming an active,~     healthy lifestyle. One strategy relies on the healthcare professional (HCP) as the primary~     communicator about COPD self-management (HCP arm), whereas the other uses a dual approach~     that involves both healthcare professionals and peer mentors delivering such communication~     (HCP plus Peer arm). Peer mentors are COPD patients and caregivers who have successfully~     managed COPD and have received foundational training on peer mentoring. Specifically, the~     study aims are to : 1) Conduct a randomized controlled trial in which the 'HCP' and 'HCP plus~     Peer' strategies are tested in 'real-world' healthcare settings; 2) compare the impact of~     these strategies on patient satisfaction, experience, activation, self- efficacy, self-care~     behavior, health status, quality of life, use of Emergency Department (ED) and hospital~     services, and survival; and, 3) compare the impact of these strategies on caregiver~     satisfaction, experience, self-efficacy, stress, and coping skills.~   "
51624|NCT02891187|"~     The OPTIONs study is a randomized controlled, non-inferiority study to evaluate postoperative~     care using outpatient clinic visits versus telephone calls for women undergoing surgery for~     pelvic floor disorders. The primary outcome is patient satisfaction using the~     Surgical-Consumer Assessment of Healthcare Providers and Systems (S-CAHPS) questionnaire~     provided by the Agency for Healthcare Research and Quality (AHRQ). Secondary outcomes include~     safety and cost analysis for patients' direct and indirect medical costs. Women who speak and~     understand either English or Spanish and planning to undergo an elective surgery for a pelvic~     disorder will be recruited. Baseline demographics, satisfaction, and cost analysis~     questionnaires will be acquired pre-operatively. Randomization will be assigned at the time~     of discharge from the hospital. Patients will either have scheduled clinic visits at 1-2~     weeks, 6 weeks, and 3 months or telephone calls by a registered nurse at these same~     intervals. Questionnaires will be completed at 3 months for satisfaction and cost analysis.~   "
51625|NCT02891174|"~     To assess the effect of routine doses of ibuprofen on post-partum blood pressure control in~     women with gestational hypertension (gHTN) or preeclampsia without severe features (preE).~   "
51626|NCT02891161|"~     This is an open label, multi-institutional, single arm study of a phase Ib study, followed by~     a phase II study of durvalumab with radiation therapy (RT) in patients with urothelial cancer~     (UC). No randomization or blinding is involved.~   "
51627|NCT02891148|"~     To investigate safety, tolerability, pharmacokinetics and pharmacodynamics following single~     rising doses of BI 690517~   "
51628|NCT02891135|"~     In its 2015 revision of the global guidelines for HIV care and treatment, the World Health~     Organization called for initiating lifelong antiretroviral treatment (ART) for all patients~     testing positive for HIV, regardless of CD4 cell count. As countries adopt the new~     recommendation, known as treat all, millions of additional patients are becoming eligible~     for ART worldwide. In sub-Saharan Africa, where most of these patients are located, studies~     continue to document high losses of treatment-eligible patients from care before they receive~     their first dose of antiretroviral medications. Among facility-level reasons for these losses~     are treatment initiation protocols that require multiple clinic visits and long waiting times~     before a patient who tests positive for HIV is dispensed an initial supply of medications.~     Simpler, more efficient, accelerated algorithms for ART initiation will be needed if treat~     all is to realize the benefits expected.~      Experts have proposed a simplified clinical algorithm to screen patients for eligibility for~     immediate ART initiation at a patient's first clinic visit, without the use of point-of-care~     laboratory test technologies. The Simplified Algorithm for Treatment Eligibility (SLATE) uses~     four screens to assess whether a patient is eligible for same-day treatment initiation: i)~     symptom report, ii) medical history, iii) brief physical examination; and iv) readiness~     assessment. SLATE is a pragmatic, individually randomized evaluation to determine the~     effectiveness of the algorithm in increasing ART initiation among non-pregnant adult~     patients. Approximately 960 HIV-infected adult patients not yet on ART will be enrolled~     during a routine clinic visit and randomized to receive the intervention or standard care.~     Patients in the intervention arm will be administered the SLATE screens; those found eligible~     under the algorithm will be offered immediate treatment initiation, while those who are not~     eligible will be referred for standard clinic care. Patients in the standard arm will be~     referred for ART initiation under standard clinic procedures. All care after the initial~     visit will be by the clinic under standard of care. If successful, SLATE will offer a~     standardized approach to collecting and interpreting a minimum set of patient data that will~     avoid delaying treatment initiation for the majority of patients who are eligible for~     immediate ART, while deferring initiation in the minority who should not start immediately.~   "
51629|NCT02891122|"~     This study aims to determine if prolonged fasting represents an independent risk factor for~     hypotension during induction of general anesthesia in the elderly.~   "
51632|NCT02891083|"~     Histological Node Negative thoracic esophageal squamous cell carcinoma（pN0 ESCC） after~     radical resection still carries the risk of recurrence after complete surgical resection,~     especially in some high-risk patients. There are still lack of knowledge on postoperative~     treatment indication and methods for pN0 ESCC.Our previous study has shown that risk of~     recurrence is associated with the location and cell differentiation of primary tumor, as well~     as the presence of lymphovascular invasion. This project is designed to study the efficacy of~     adjuvant therapies for at patients with pN0 ESCC and above mentioned risk factors of~     recurrence after radical surgery. We aim to compare the differences among adjuvant~     chemotherapy, adjuvant radiotherapy, and surgery alone for pN0 ESCC by prospective randomized~     controlled trial. There has been no similar studies in esophageal cancer previously reported~     with similar design. The results of this study is expected to have a high clinical relevance.~   "
51633|NCT02891070|"~     The objective of this study is to evaluate the safety and efficacy of FS VH S/D 500 s-apr for~     use as an adjunct to sutured dural repair in cranial surgery.~   "
51634|NCT02891057|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
51635|NCT02891044|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
51636|NCT02891031|"~     The aim of this study is to evaluate the effects of Rhus coriaria L. (Rhus) commonly known as~     Somagh on serum uric acid levels.~   "
51637|NCT02891018|"~     Study purpose The safety and efficacy of paclitaxel controlled release balloon catheter~     Vasoguard TM in treatment of in-stent restenosis.~      Study group Experimental group: paclitaxel controlled release balloon catheter Vasoguard TM~     Control group: paclitaxel release coronary balloon catheter SeQuent Please~   "
51638|NCT02891005|"~     Study Purpose The safety and efficacy of paclitaxel controlled release balloon catheter~     VasoguardTM in treatment of small vessel lesion.~      Study Group Experimental group: paclitaxel controlled release balloon catheter (VasoguardTM)~     Control group: common balloon catheter (Maverick2)~   "
51639|NCT02890992|"~     Primary Objective:~      To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels~     after 8 weeks of treatment in heterozygous familial hypercholesterolemia (heFH) patients age~     of 8 to 17 years, with LDL-C ≥130 mg/dL (3.37 mmol/L) on optimal stable daily dose of statin~     therapy +/- other lipid modifying therapies (LMTs) or a stable dose of non-statin LMTs in~     case of intolerance to statins for at least 4 weeks prior to the screening period.~      Secondary Objective:~        -  To evaluate the safety and tolerability of alirocumab.~        -  To evaluate the pharmacokinetics profile of alirocumab.~        -  To evaluate the effects of alirocumab on other lipid parameters.~   "
51640|NCT02890979|"~     This pilot clinical trial studies how well a swallowable sponge cell sampling device and next~     generation sequencing work in detecting esophageal cancer in patients with low or high grade~     dysplasia, Barrett esophagus, or gastroesophageal reflux disease. Checking biomarkers in~     abnormal esophageal cells using a swallowable sponge cell sampling device and next generation~     sequencing may improve diagnosis and treatment of esophageal cancer.~   "
51641|NCT02890966|"~     The objective of the study is to assess the tolerance, pharmacokinetic and pharmacodynamic~     properties of multiple dose adminstration of SHR4640 in healthy volunteers.~   "
51642|NCT02890953|"~     The objective of this study is to evaluate the efficacy and safety of a single~     intraventricular administration of Pneumostem® for treatment of Intraventricular hemorrhage~     (IVH) in high-risk premature infants by comparing Pneumostem-treated group with a control~     group.~   "
51643|NCT02890940|"~     The goal of this study is to explore whether facial expression changes in visual portraits~     correlate with Quality of Life (QOL) questionnaire responses before and after pet therapy~     sessions and to compare scores of QOL questionnaires before and after pet therapy.~   "
51644|NCT02890927|"~     The primary objective of the evaluation study is to determine if geriatric co-management is~     superior to standard of care in preventing functional decline in older patients admitted for~     acute heart disease or Transcatheter Aortic Valve Implementation (TAVI) to the cardiology~     units of the University Hospitals Leuven.~   "
51645|NCT02890914|"~     Obstetrics and gynecology residents are deemed to be proficient in transvaginal ultrasound~     (TVUS) upon graduation from an accredited program, although TVUS education in residency is~     not standardized. The objective of this study is to assess for improvement in transvaginal~     ultrasound knowledge among residents after viewing an educational DVD.~   "
51646|NCT02890901|"~     The determinants associated with severe outcome and death from Escherichia coli bloodstream~     infections (BSI) remain poorly understood. The epidemiology of E. coli BSI has recently~     changed dramatically with the global emergence of multiresistant strains producing~     extended-spectrum ß-lactamases (ESBL). Outcome is worse in case of ESBL-E. coli, which may be~     due to the intrinsic virulence of ESBL-E. coli or to a delayed adequate empirical antibiotic~     therapy because of multiresistance. Predicting the severity of an infection as soon as the~     initial clinical assessment is of major importance to provide the best care, while limiting~     unnecessary hospitalizations and costs. Yet, no simple clinical score exists to predict the~     severity of E. coli infections.~      In a translational approach, the investigators will include during a maximum of one year 500~     adults with E. coli BSI hospitalized in 7 hospitals in the Paris area, France. Precise~     clinical data will be collected at inclusion and 28 days after inclusion or upon patient's~     discharge (if before day 28). The primary endpoint of the study is death from E. coli BSI at~     day 28.~      The first aim is to determine risk-factors for death at day 28, including clinical and~     bacteriological factors (determined by WGS) in the era of the global emergence of ESBL~     producing E. coli. The second aim is to determine virulence characteristics of ESBL strains~     both at the genome and phenotypic level thanks to a mouse model of septicaemia, and compare~     them to the clinical data. The third aim, will establish and evaluate a simple clinical~     severity score (named COLISCORE), in order to help clinician evaluate patients' severity upon~     initial clinical evaluation and particularly to detect patients at risk of severe outcome.~     The ultimate goal of this work is to have a clinical impact on patients' management, by~     understanding the determinants of patient severity due to E. coli BSI in the context of~     current major epidemiological changes.~   "
51647|NCT02890888|"~     Patients will have a Functional MRI before and after 10 hyperbaric Oxygen treatments.~   "
51648|NCT02890875|"~     Patients on long-term parenteral nutrition (PN) are at high risk for central line-associated~     bloodstream infections (CLABSI). This study evaluates the efficacy and safety of ethanol lock~     therapy for CLABSI prophylaxis in adult patients on PN.~   "
51649|NCT02890862|"~     Development of reliable and objective evaluation methods is required for natural~     upper-extremity tasks. Three-dimensional imaging measurement techniques are a powerful tool~     for quantitative assessment of multijoint movements.~   "
51670|NCT02890589|"~     To assess strut coverage in patients presenting an acute myocardial infarction and treated~     either with the SYNERGY stent or the Bioresorbable Vascular Scaffold, through a parallel~     group design.~   "
51650|NCT02890849|"~     The detection of tissue PD-L1 immunohistochemistry in Non-small cell lung cancer (NSCLC) has~     an important role in guiding for the treatment of immune detection point. At the same~     time,tissue detection is time-consuming and laborious, liquid biopsy can reflect the~     information of tumor tissue,PD-L1 mRNA in plasma exosomes (pExo) is expected to be simple,~     rapid, non-invasive means of detection. The project is planned to explore the consistency~     analysis of PD-L1 expression level detected in cancer tissues and pExo.We have designed to~     detected the expression levels of PD-L1 mRNA and protein in cancer tissue and detected the~     expression levels of PD-L1 mRNA in pExo.By using variance analysis of repeated measures~     design information. Thus exploring the consistency analysis of PD-L1 expression level~     detected in tissues and pExo,guiding clinical practice of radiotherapy combining with~     immunotherapy.~   "
51651|NCT02890836|"~     Aim: First, to investigate the prevalence of a) confirmed hypertension, b) white coat~     hypertension and c) normal blood pressure in pregnant women with pre-existing diabetes.~     Second, to explore the prevalence of preeclampsia and preterm delivery in women with~     pre-existing diabetes with a) confirmed hypertension, b) white coat hypertension and c)~     normal blood pressure before entering the third trimester of pregnancy. Third, to explore the~     influence of lifestyle, gestational weight gain and mental well-being on confirmed~     hypertension and preeclampsia in pregnant women with diabetes.~      Design: A prospective multicentre observational study where approximately 400 pregnant women~     with pre-existing diabetes are offered measurements of office blood pressure (BP) and home BP~     for three days three times during pregnancy as well as when the routinely measured office BP~     exceeds 135/85 mmHg. The prevalence of confirmed hypertension (office BP >135/85 mmHg and~     home BP >130/80 mmHg) and white coat hypertension (office BP >135/85 mmHg but home BP ≤130/80~     mmHg) will be determined. Women with confirmed hypertension are offered antihypertensive~     treatment mainly with methyldopa. In women with a) confirmed hypertension, b) white coat~     hypertension, and c) normal blood pressure before entering third trimester of pregnancy, the~     prevalence of preeclampsia and preterm delivery will be evaluated. Possible side effects of~     antihypertensive treatment including impaired fetal haemodynamics and lower infant birth~     weight will be recorded. The women will complete food diaries and questionnaires on lifestyle~     and mental health three times in pregnancy in order to evaluate the influence of these~     parameters on hypertension and preeclampsia.~   "
51652|NCT02890823|"~     To characterize the effect of three different doses of vitamin D3 supplementation on serum~     25-hydroxyvitamin D (25(OH)D) changes in epilepsy patients receiving enzyme-inducing~     antiepileptic drugs (EIAEDs) versus patients receiving non enzyme-inducing antiepileptic~     drugs (non-EIAEDs), and to determine the prevalence of and risk factors for hypovitaminosis D~     among Thai patients with epilepsy.~   "
51653|NCT02890810|"~     In this placebo controlled, patient and assessor blinded clinical trial, the investigators~     will administer electroacupuncture vs sham electroacupuncture to patients suffering from~     chronic low back pain, and monitor their symptoms as well as collecting objective outcome~     measures. The investigators objective is to identify predictors of pain reduction and~     functional improvement with electroacupuncture vs placebo.~   "
51654|NCT02890797|"~     The diagnosis of bronchiolitis, the most frequent lung infectious disease in infancy, is~     based on clinical examination. Chest X-ray is proposed when a lung parenchymal condensation~     is suspected. Chest ultrasound is supposed to be a useful tool in the diagnosis of these~     complication but is poorly evaluated. We aim to compare chest X-ray and chest ultrasound for~     the diagnosis of parenchymal condensation in infant with bronchiolitis.~   "
51655|NCT02890784|"~     Treatment optimization for patients with chronic myeloid leukemia (CML) with treatment naïve~     disease (1st line) and patients with resistance or intolerance against alternative Abl-Kinase~     Inhibitors (≥2nd line) (DasaHIT Trial (Dasatinib Holiday for Improved Tolerability))~   "
51656|NCT02890771|"~     Periodontal disease is considered as inflammatory, multifactorial, and threshold disease~     accompanied by destruction of periodontium and eventually the loss of natural teeth.~     Periodontal disease is highly prevalent dental disease especially, in developing and~     underdeveloped countries affecting more or less 80% of the population. For the prevention of~     this highly prevalent dental affliction, still no effective and practical preventive measures~     are available which can reduce its high prevalence rate though, lot of research work is going~     on.~   "
51657|NCT02890758|"~     The purpose of this study is to find the number of natural killer (NK) cells from non-HLA~     matched donors that can be safely infused into patients with cancer. NK cells are a form of~     lymphocytes that defend against cancer cells. NK cells in cancer patients do not work well to~     fight cancer. In this study, the NK cells are being donated by healthy individuals without~     cancer who are not matched by human leukocyte antigen (HLA) genes to patients. After~     receiving these NK cells, patients may also be given a drug called ALT803. ALT803 is a~     protein that keeps NK cells alive, helps them grow in number and supports their~     cancer-fighting characteristics. HLA-unmatched NK cell infusion is investigational~     (experimental) because the process has not approved by the Food and Drug Administration~     (FDA).~   "
51658|NCT02890745|"~     The purpose of this study is to investigate the effect of empagliflozin on oxidative stress~     in patients with type 2 diabetes. The association is examined by comparing the difference in~     oxidative modifications before and after 14 days treatment with 25 mg empagliflozin compared~     to placebo treatment. The study is randomised, double-blinded, and placebo controlled. Each~     treatment group consists of 17 males with type 2 diabetes. Oxidative modifications are~     measured by urinary excretion of 8-oxo-7,8-dihydro-2'-deoxyguanosine and~     8-oxo-7,8-dihydroguanosine. A student t-test will be performed to compare the drug treatment~     with placebo. The results will be published in a peer-review journal.~   "
51659|NCT02890732|"~     This project will benefit from the results of the concept study conducted from July to~     October 2014 from groups of coronary patients. This first study will help to develop the~     precise contours of Appet HEART application for the production of the prototype version used~     in the clinical feasibility study.~      The objectives of the feasibility study are:~        1. assess the rate of use of the application~        2. to determine the ideal target population of the application~        3. to evaluate the effectiveness of the application~        4. to measure the risks and potential limitations of its use~        5. to determine the medical and economic impact of this application~   "
59161|NCT02792491|"~     This is Phase II prospective trial of addition of rituximab to reduced dose CHOP chemotherapy~     in DLBC L patients aged 65 years and over.~   "
51662|NCT02890693|"~     MySweetHeart Trial is a randomized controlled trial to test the effect of a multidimensional~     interdisciplinary lifestyle and psychosocial intervention to improve the cardio-metabolic and~     mental health of women with GDM and their offspring.~      Primary objective of MySweetHeart Trial:~      To test the effect of a multidimensional interdisciplinary lifestyle and psychosocial~     intervention in women with GDM to improve 1) their metabolic health (decrease in maternal~     weight between study inclusion after GDM diagnosis and at 1 yr postpartum) and 2) their~     mental health (decrease in maternal symptoms of depression during the same time period).~      Secondary objective of MySweetHeart Trial:~      To test the effect of a multidimensional interdisciplinary lifestyle and psychosocial~     intervention to improve other cardio-metabolic and mental health markers in women with GDM~     and their offspring.~      MySweetHeart trial is linked to MySweetHeart Cohort, an observational cohort study that~     assesses the effect of GDM on offspring cardiovascular health early in life. The principal~     investigators of the cohort are Nicole Sekarski and Arnaud Chiolero (University Hospital~     Lausanne, Switzerland). Their primary objective is to assess the effect of GDM on the~     surrogate markers of cardiovascular disease (CVD) at birth (left ventricular mass index and~     subclinical atherosclerosis) and the secondary objective is to assess the effect of GDM on~     the cardiovascular structure and function during the fetal period and neonatal adverse~     cardiovascular risk factors.~   "
51663|NCT02890680|"~     The purpose of this study is to evaluate the bone regeneration after impacted third molar~     surgery on split mouth design using platelet-rich fibrin.~   "
51664|NCT02890667|"~     This study is a population based observational study conducted on the French administrative~     databases to estimate cancer incidence in 2012 by using the ECHANTILLON GENERALISTE DES~     BENEFICIAIRES (EGB, a 1/97th dynamic random sample of the SNIIRAM).~      The EGB database contains anonymous and prospectively recorded data about all beneficiaries'~     medical reimbursements. Many algorithm definitions are defined to estimate the incident rate~     of cancer in 2012 from the EGB database. The incidence rates obtained by each algorithm~     definition are compared to national incidence rates by indirect age and sex standardization.~     National incidence rates are obtained from FRANCE CANCER INCIDENCE ET MORTALITE (FRANCIM):~     the French network of cancer registries.~   "
51665|NCT02890654|"~     Around the scoliosis surgery, the pain (pre or post operative, physical, psychological,~     fantasy or real) is a major concern for adolescents and their families. She is also a key~     concern of caregivers, both its assessment and management is complex. this pain involved~     predominantly in the quality of life of these teenagers today who will become the adults of~     tomorrow.~      To date in France, no study aims to describe and evaluate the effect of a multidisciplinary~     approach and its impact on the quality of life of these young people made.~      The present study wish to prevent, anticipate and limit the short, medium and long-term~     morbidity. Focus will be on pain and its management, on preparing for surgery,~     hospitalization, follow-up after surgery, rehabilitation until recovery.~      Help teens reclaim their bodies after the changes caused by the intervention is a major~     issue.~      This study believe that support good quality, adapted to patient needs will limit operating~     and postoperative pain in the medium and long term.~      Medical team developed special attention around the teenagers that are operated for scoliosis~     (teen groups and parent groups, interview before the operation and counseling, physiotherapy~     support ...).~      The present study would systematize data collections in order to have a comprehensive and~     accurate assessment of the care.~      The qualitative research will focus on the multidisciplinary care in an effort to evaluate~     the whole course of these teenagers, their experience and to identify efforts to put in place~     to optimize the current care.~   "
51666|NCT02890641|"~     Genetic abnormalities in focal epilepsies are well known. A novel gene (DEPDC5) was~     identified, associated with various genotypes of epilepsies. Recently, DEPDC5 mutations were~     identified also inside focal cortical dysplasias. This could suggest that a somatic mutation~     in DEPDC5 could be responsible for the cortical dysplasia. The study aims to identify various~     genetic mutations responsible for drug-resistant focal epilepsies due to Focal cortical~     dysplasia in children undergoing surgery for epilepsies due to focal cortical dysplasias in~     Rothschild Foundation, Paris. Patients and their parents will be recruited to identify~     genetic abnormalities both in lymphocytic and cortical DNA.~   "
51667|NCT02890628|"~     This study is to explore perceptions, experiences, beliefs and knowledge around teenage~     pregnancy, motherhood, sexual and reproductive health, family planning and support structures~     adolescent refugees and migrants and to identify demographic, social and medical~     characteristics of study participants.~   "
51668|NCT02890615|"~     Depressive symptoms are common in cancer survivors; 15% or more of cancer patients, even 1~     year after diagnosis, experience depressive symptoms that can have a negative impact on their~     quality of life. Canadian care guidelines for cancer survivors recommend supporting the~     active engagement of survivors in their self-care.~      This study is an evaluation of the effect of a depression self-care program which includes a~     self-care toolkit and support in the form of regular telephone calls from a self-care coach.~      The toolkit contains tools that help cancer survivors:~        1. Learn new information to better understand depression. This can help people feel that~          they are not alone, and that their experience is not abnormal. Better understanding a~          condition also helps people feel more confident in their communications with health care~          professionals and can make it easier to share their experience with family and friends.~        2. Learn and practice new coping skills. This can help people feel confident that they can~          engage in the behaviours that have been shown to be beneficial for mood, e.g.~          restructuring thoughts, problem solving, and planning pleasant activities.~      People eligible for the study are aged 18 and over, 1-10 years post-diagnosis, have completed~     primary cancer treatment (chemotherapy, radiation therapy or surgery) for any type of cancer,~     and have moderate depressive symptoms (as measured by a Patient Health Questionnaire (PHQ-9)~     score of 8-19). Recruitment will be conducted at cancer care centres in Montreal and at the~     Princess Margaret Cancer Centre in Toronto, and via community cancer support groups in Quebec~     and Ontario. Each participant enrolled in the study will receive the self-care toolkit (half~     will receive the toolkit and support calls at the start of the study, and half will receive~     the toolkit at the end), and will be followed for 6 months.~      This proposed self-care program is innovative in its approach to the treatment of depression~     and has the potential to significantly improve the quality of life for Canadian cancer~     survivors with persistent depressive symptoms. The results of the study will determine~     whether the supported depression self-care program for cancer survivors is effective. The~     program is designed to be sustainable and widely applicable as it involves minimal costs, and~     the coaching can be delivered by telephone by volunteers in hospital and community settings.~     Investigators will work with clinical stakeholders and patient representatives to ensure that~     deliverables are relevant to the target population. Specific deliverables (in both French and~     English) include: a toolkit with a manual describing its use; a manual detailing coaching~     procedures; reports for decision makers and community cancer care groups; and short summaries~     for stakeholder groups.~   "
51669|NCT02890602|"~     This is a phase Ⅱ study of erythropoietin for management of anemia caused by chemotherapy in~     patients with Diffuse Large B-cell Lymphoma. The investigators want to investigate~     hematopoietic response of darbepoietin alfa and the quality of life assessment of~     increasement of hemoglobin.~   "
59162|NCT02792478|"~     Analysis of freely circulating DNA in liquid biopsies using the BEAMing method~   "
51671|NCT02890576|"~     The number of patients with cochlear implants increases every year, constituting an active~     queue increasingly important (60 new cases per year in Toulouse, active list in 2013: 380~     adult patients). The number of approved cochlear implant centers is limited by guardianships,~     and corresponds to the Hospitals University. It is not possible to create networks of~     correspondents. Teams of implantation centers must meet the needs of new patients and ensure~     continuity of care for patients already implanted: speech therapy monitoring, adjustment and~     rehabilitation.~      In case of malfunction of the implant, patients use in first-line reference center. The~     increasing number of patients leads to a lack of specialized teams that can not meet the~     demands of patients in a timely manner, while continuing to provide support for new patients.~     It is therefore necessary to find solutions to improve the service provided to patients who~     received a cochlear implant system to respond quickly and effectively to the request of~     troubled patients, while optimizing the workload of the teams . The introduction of a~     telemedicine platform is expected to achieve these goals, distinguishing minor malfunctions,~     not requiring a consultation in a center, and the most complex situations requiring~     consultation in a center.~   "
51672|NCT02890563|"~     Study purpose is to research whether compression therapy is beneficial after truncal vein~     RF-ablation and distal sclerotherapy done in the same session when needed. Patients will be~     randomised to either no compression group (Group I) or compression group (Group II)~   "
51673|NCT02890550|"~     The aim of the study is to characterize the clinical manifestations of ALMS within the~     ciliopathies to prevent complications and determine preventive and therapeutic targets.~      The investigators believe that the clinical consequences of mutations in the gene result~     ALMS1 unprecedented protests and the ALMS study should help to be informed, not only about~     the understanding and decision support other ciliopathies, but also about some common~     diseases, as some physiopathogenic roads could be common; the rare disease being exacerbated~     a model of the channel concerned. Secondarily, the clinical data generated by this project~     will also be used as part of basic research (eg comparison with results in animal models, use~     of human cells for in vitro studies or transcriptomic ....) (which will be a secondary~     upgrading to this work).~   "
51674|NCT02890537|"~     Non-traumatic osteonecrosis is a painful disorder of the hip characterized by a necrosis of~     the osteomedullary tissue, which leads to subchondral bone collapse and joint destruction.~     Core decompression is currently the treatment of choice for early stage osteonecrosis of the~     femoral head. This method consists in decompressing the rigid intra-osseous chamber to~     promote revascularization, thus halting progression of the disease and stimulating repair.~     Still this treatment remains highly controversial, since the success rates of the first~     studies have not been repeated.~      The exact pathology mechanisms involved in osteonecrosis have not yet be fully elucidated.~     Several hypotheses have been evoked, including fat embolism, trabecular bone microfractures,~     microvascular tamponade and, more recently, impaired bone and/or mesenchymal cells~     recruitment.~      Three studies have indicated the potential clinical benefits of cell-based approaches for the~     treatment of osteonecrosis (Hernigou 1997, Hernigou & Beaujean 2002, Gangji et al. 2004).~     This is on the basis of these observations that a proprietary population of autologous~     osteoblastic cells (PREOB®) has been developed.~      This Phase 2B study aims at demonstrating the efficacy and safety of PREOB® in the treatment~     of early stage osteonecrosis of the femoral head. The primary goal of this study was to~     investigate the safety and efficacy of the implantation of the investigational product PREOB®~     (human autologous bone marrow-derived osteoblastic cells) in comparison to bone marrow~     concentrate (BMC) when implanted at the osteonecrotic lesion of the femoral head, with a~     follow-up period of up to 5 years.~   "
51675|NCT02890524|"~     The investigators will investigate whether the night guard can suppress the development of~     recurrent aphthous stomatitis (RAS). The investigators will record the patients' oral~     condition for 60 days before and after intervention with the night guard made of~     Ethylene-Vinyl Acetate copolymer (EVA). The patients' saliva will be analyzed for measurement~     of inflammatory cytokines or oxidative stress.~   "
51676|NCT02890511|"~     A study of DHP107, a novel oral paclitaxel formulation, to determine maximum tolerated dose~     and recommended dose for phase II trial in patients with advanced solid cancer and explore~     efficacy of DHP107 in patients with gastric cancer~   "
51677|NCT02890498|"~     Retrospective analysis of vaginal microbiota in the post-operative course of patient operated~     for genital prolapse with vaginal mesh with or without mesh related complication~   "
51678|NCT02890485|"~     This study is testing the effectiveness of dry needling for pain management and on muscle~     strength and leg function for those with knee pain. Dry needling consists of small,~     monofilament needles that are administered directly into the tissue and manipulated to make~     the muscle relax for pain relief. This technique is used to treat dysfunctions in skeletal~     muscle and connective tissue to help diminish pain, reduce impairments of body structure and~     restore function.~   "
51679|NCT02890472|"~     22q11.2 microdeletion seems the prenatally under-diagnosed . Indeed , there is a mismatch~     between the series on the heart rate of 22q11.2 antenatal 84% against 30% in the adult series~     despite a perinatal mortality of 16% suggesting opportunities for improvement in the prenatal~     diagnosis of fetus with a microdeletion 22q11.2 , especially without heart disease~   "
51680|NCT02890459|"~     The success of combination HIV prevention efforts, including HIV treatment as prevention,~     hinges on universal, routine HIV testing with effective treatment after HIV diagnosis. The~     proposed study will evaluate the comparative effectiveness and sustainability of innovative~     incentive strategies, informed directly by behavioral economics and decision psychology, to~     promote HIV testing among men and HIV treatment among HIV-infected adults in rural Uganda.~   "
51681|NCT02890446|"~     This study compares the effects of an internal versus an external focus of attention on motor~     training of the affected arm for individuals with stroke. Participants were randomly assigned~     to either the internal or external focus treatment groups and received 12 sessions of arm~     training.~   "
51682|NCT02890433|"~     The national recommendations promote the applying of the Contact Additional Precautions (CAP)~     with the Standard Precautions (SP) to limit the transmission of multi-drug resistant (MDR)~     bacteria. However, that could entail more costs and a reduction of quality of the patient~     care.~   "
60396|NCT02776319|"~     The objective of the study is to determine the effect of non-invasive brain stimulation on~     craving for tobacco and brain metabolites.~   "
51684|NCT02890407|"~     The association study will compare the allele frequencies of polymorphisms of a single~     nucleotide (SNP) in the population of individuals with aortic stenosis compared to a control~     population.~      Patients will be included only if they are suffering from a typical form of tight and~     surgical tricuspid aortic stenosis. Patients will therefore only included if they are~     suffering from aortic stenosis, the surface is less than 1 cm² and if histological analysis~     or failing intraoperative findings of the surgeon showed a tricuspid aortic stenosis.~   "
51685|NCT02890394|"~     The project is based on checking the effectiveness of the technique of suboccipital~     inhibition in patients with mechanical neck pain. Suboccipital inhibition technique involves~     the placement of the hands of the physiotherapist under the patient's head so that fingers~     can feel the spinous processes of the cervical vertebrae. Then the fingers slowly leads~     upward to contact the occipital condyles. At this point the investigator should gently move~     your fingers down, finding the space between the condyles and the spinous process of the~     axis. Then, flexing the metacarpophalangeal joints at 90 degrees, slowly raises the skull. In~     this technique the investigator would be carrying out the relaxation of the suboccipital~     muscles: lower rectus capitis posterior, superior oblique head straight back and head higher.~     It is a technique used very often but without knowledge about the time needed for~     implementation. In several studies that have used the technique it has been maintained for~     2.4 or 10 minutes without agreeing how long is necessary. The study will consist of three~     groups formed by patients with mechanical neck pain that they applied the technique two, four~     or ten minutes and a control group of patients with mechanical neck pain. The four groups~     were measured before and after treatment the pain threshold to pressure by algometer and~     conduct the test repositioning of the head to show any changes after application of the~     technique.~   "
51686|NCT02890381|"~     The purpose of this study is to evaluate the safety, infectivity, and immunogenicity of a~     single dose of a recombinant live-attenuated respiratory syncytial virus (RSV) vaccine in~     RSV-seronegative infants 6 to 24 months of age.~      This study is a companion study to CIR 312.~   "
51687|NCT02890368|"~     This is a multicenter, open-label, phase 1 study conducted to test intratumoral injections of~     TTI-621 in subjects that have relapsed and refractory percutaneously accessible solid tumors~     or mycosis fungoides.~      The study will be performed in two different parts. Part 1 is the Dose Escalation phase and~     Part 2 is the Dose Expansion phase.~      The purpose of this study is to characterize the safety profile of TTI-621 and to determine~     the optimal dose and delivery schedule of TTI-621. In addition, the safety and antitumor~     activity of TTI-621 will be evaluated in combination with other anti-cancer agents or~     radiation.~   "
51688|NCT02890355|"~     This randomized phase II trial studies how well modified irinotecan hydrochloride, leucovorin~     calcium, fluorouracil (FOLFIRI) and veliparib as a second line of therapy work compared to~     FOLFIRI in treating patients with pancreatic cancer that has come back after a period of~     improvement (metastatic). Drugs used in chemotherapy, such as irinotecan hydrochloride,~     leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Veliparib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. It is not yet known whether modified FOLFIRI and veliparib as second~     line therapy is more effective than FOLFIRI alone in treating metastatic pancreatic cancer.~   "
51689|NCT02890342|"~     Background:~      People s bodies need to break down food into the chemicals. These chemicals are used for~     energy and growth. Some people cannot process all chemicals very well. Too much of some~     chemicals can cause diseases. One of these diseases is called propionic acidemia (PA). People~     with PA can have problems with growth, learning heart, abdomen, and other organs. Researchers~     want to better understand how these problems happen.~      Objective:~      To learn more about propionic acidemia and the genes that might contribute to it.~      Eligibility:~      People at least 2 years old with PA who can travel to the clinic~      Some unaffected family members~      Design:~      Participants will have a 3 to 5-day hospital visit every year or every few years. Family~     members may have just 1 visit.~      During the family member visit, they may have:~      Medical history~      Physical exam~      Samples of blood and urine~      Questions about diet and a food diary~      Doctors and nurses may do additional studies:~      Samples of saliva, skin and stool~      Fluid from a gastronomy tube, if participants have one~      Dental and eye evaluations~      A kidney test - a small amount of dye will be injected and blood will be collected.~      Consultations with specialists~      A test of calories needed at rest. A clear plastic tent is placed over the participant to~     measure breathing.~      Stable isotope study. Participants will take a nonradioactive substance then blow into a bag.~      Photos taken of the face and body with underwear on~      Ultrasound of the abdomen~      Heart tests~      Hand x-ray~      Brain scan~      Participants may have other tests if study doctors recommend them. They will get the results~     of standard medical tests and genetic tests.~   "
51690|NCT02890329|"~     This phase I trial studies the side effects and best dose of ipilimumab when given together~     with decitabine in treating patients with myelodysplastic syndrome or acute myeloid leukemia~     that has returned after a period of improvement or does not respond to treatment. Monoclonal~     antibodies, such as ipilimumab, may block cancer growth in different ways by targeting~     certain cells. Drugs used in chemotherapy, such as decitabine, work in different ways to stop~     the growth of cancer cells, either by killing the cells, by stopping them from dividing, or~     by stopping them from spreading. Giving ipilimumab and decitabine may work better in treating~     patients with relapsed or refractory myelodysplastic syndrome or acute myeloid leukemia.~   "
51691|NCT02890316|"~     To evaluate the effects of homeopathy treatment on radiotherapy-induced fatigue, cognitive~     and emotional functions.~   "
51692|NCT02890303|"~     This study will evaluate outcome in subjects who have elected to have Zepto capsulotomies~     during cataract surgery with phacoemulsification.~   "
51704|NCT02890147|"~     Connective tissue diseases (CTD) or systemic autoimmune diseases (SADs) as they are known~     today are a group of chronic inflammatory conditions with autoimmune aetiology with few~     treatment options and difficult diagnosis.Brest team contribute to perform a new~     classification of the following systemic autoimmune diseases in a European Union's Seventh~     Framework Programme. The aim of this research is to constitute a Healthy Volunteers cohort to~     compare with systemic autoimmune diseases cohort into molecular clusters instead of clinical~     entities through the determination of molecular profiles using several Omics techniques.~   "
51693|NCT02890290|"~     The purpose of this study is to determine whether a marine protein hydrolysate given as a~     supplement can prevent age related loss of muscle mass and loss of physical function in frail~     elderly. The study will recruit elderly living at home with help from municipal health care~     services, and a secondary goal of the study is to describe food habits, seafood intake and~     nutritional status in this group of patients.~      Edit: the recruitment procedure was changed in august 2017, to include elderly without help~     from municipal health care services. Participants are now recruited trough media and~     organizations for elderly, and these changes in recruitment procedure was approved by the~     ethics committee august 2017.~   "
51694|NCT02890277|"~     Nonneoplastic epithelial disorders of skin and mucosa of vulva refer to a group of chronic~     diseases shown as female genital skin and mucosal tissue degeneration and pigmentation~     change. The main symptoms are vulval itching, squamous cell hyperplasia, vulval and perianal~     skin atrophy or thinning, hypopigmentation. The current treatments are primarily local drug~     or surgical treatments. However, the effect is not good enough, but the diseases often recur~     and severely affect patients' quality of life. In this study, the investigators combined the~     technology of high intensity focused ultrasound (HIFU) (ultrasound device made by Mianyang~     Sonic electronic LLC, Mianyang China, registration number: 2005-2230099} with special drug to~     treat. The data from colposcopy and biopsy pathology were collected before and after~     treatment to create the objective identifying degree of the disease by with grading methods~     and evaluate the treatment effect. At the meantime, the standardized treatment procedure,~     methods and efficacy criterion were all stipulated to achieve satisfactory results, which~     could be used to clinical treatments. So far, the investigators have not seen similar study~     reported internationally.~   "
51695|NCT02890264|"~     The main purpose for holding this survey is epidemiological surveillance, it must provide the~     indicators that contribute to the evaluation of the plan improvement of the quality of life~     in chronic diseases and monitoring the goal of 81 health law public in August 2004. This~     survey is intended to be renewed during the implementation period of the public health law to~     provide plan monitoring indicators.~      The main objective is : To describe the quality of life of patients with major end-stage~     renal disease treated with dialysis method for at least one year.~      The seconds objectives are :~        -  To contribute to the knowledge of the key determinants of the quality of life among~          chronic renal failure patients.~        -  To study the influence on way of giving a questionnaire about assessment of level of~          quality of life~   "
51696|NCT02890251|"~     The purpose is to describe the level of visual maturation of premature newborns at term~     equivalent age.~      The secondary purpose is to determine factors associated to an altered level of visual~     maturation, through an exploratory approach.~   "
51697|NCT02890238|"~     100 women with infertility classified into 2 groups.~      Group A: Included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2~     times/day from 2rd-7th day of the cycle and sildeaynafil citrate 20mg tab from 7th-11th day~     of the same cycle orally 3 times/day.~      Group B: Included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2~     times/day from 2rd-7th day of the cycle and placebo tablets from 7th-11th day of the same~     cycle orally 3 times/day.~   "
51698|NCT02890225|"~     The treatment of renal calculus by retrograde intrarenal surgery(RIRS) isn't able to~     eliminate stone completely~   "
51699|NCT02890212|"~     The main goals of antidepressant treatments are to achieve remission of depressive episodes~     and prevent recurrences. However, clinical trials designed to approve antidepressants targets~     a response rate of at least 50%, which is considered partially effective. Therefore, there is~     a need for new treatment strategies, including augmentation with other substances such as~     lithium. This research aims to verify through a pilot study, the effect of selenium as an~     augmentation treatment for sertraline-resistant major depression. This clinical trial was~     designed to be a randomized, placebo-controlled, double-blind trial evaluating the effect of~     selenium or placebo in subjects diagnosed with major depression who have not responded to~     treatment with sertraline~   "
51700|NCT02890199|"~     During surgery for pelvic organ prolapse, it is common for the surgeon to inject fluid into~     the vaginal tissues to help with tissue dissection. It is common that anesthetic medication~     is mixed into this fluid to help with pain control after surgery. Usually the pain medication~     injected is short-acting. In this study the investigators plan to compare the usual~     short-acting injected pain medication with a long-acting injected pain medication to evaluate~     whether this improves pain control after surgery.~      One type surgical procedure for prolapse will be evaluated. The procedure is sacrospinous~     ligament fixation. This is suspension of the vagina to treat pelvic organ prolapse. Study~     participants will be randomized to one of two study groups:~        1. Lidocaine group (short-acting medication).~        2. Liposomal bupivacaine group (long-acting medication)~      Information will be collected on study participants, including: demographics, procedure data,~     and post-operative information. The primary outcome of this study is determine if use of~     long-acting injected local anesthesia at the time of sacrospinous ligament fixation leads to~     less post-operative pain compared to short-acting local anesthesia.~      Secondary outcomes include:~        1. post-operative opioid medication use~        2. return to baseline pain status~        3. post-operative time to first bowel movement~        4. post-operative antiemetic use (nausea medication)~        5. results of voiding trial after surgery~        6. patient satisfaction with pain control~   "
51701|NCT02890186|"~     To investigate the application of closed target-controlled infusion(TCI) of propofol and~     remifentanil guided by Narcotrend index in the anterior cervical decompression and fusion~     with internal fixation surgery.~   "
51702|NCT02890173|"~     To evaluate antihypertensive effect and safety of CS-3150 compared to Eplerenone in patients~     with essential hypertension.~   "
51703|NCT02890160|"~     The FUTURE-II study is a confirmative clinical trial for Sirolimus Target Eluting~     Bioresorbable Vascular Scaffold (Firesorb) after the feasibility and safety of the device has~     been preliminary confirmed in a small-scale First-in-Man clinical trial.~   "
51729|NCT02889822|"~     Conducted in Chinese healthy adult volunteers,the study aims to observe the safety and~     tolerability of single/multiple-dose administration of different doses of Alprostadil~     Liposome for Injection as well as to confirm the safety dose range.~   "
53302|NCT02869256|"~     It will be a centralized database , multicentre (6 centers) , regional, chronic myelogenous~     leukemia cases of registration (CML) prospectively and retrospectively.~   "
51705|NCT02890134|"~     Connective tissue diseases (CTD) or systemic autoimmune diseases (SADs) as they are known~     today are a group of chronic inflammatory conditions with autoimmune aetiology with few~     treatment options and difficult diagnosis.Brest team contribute to performe a new~     classification of the following systemic autoimmune diseases in a European Union's Seventh~     Framework Programme. The aim of this research consiteis to reclassify the individuals~     affected by SADs into molecular clusters instead of clinical entities through the~     determination of molecular profiles using several Omics techniques.~   "
51706|NCT02890121|"~     Connective tissue diseases (CTD) or systemic autoimmune diseases (SADs) as they are known~     today are a group of chronic inflammatory conditions with autoimmune aetiology with few~     treatment options and difficult diagnosis.Brest team contribute to perform a new~     classification of the following systemic autoimmune diseases in a European Union's Seventh~     Framework Programme. The aim of this research is to reclassify the individuals affected by~     SADs into molecular clusters instead of clinical entities through the determination of~     molecular profiles using several Omics techniques.~   "
51707|NCT02890108|"~     This study will compare the effect of acute consumption of two carbonated drinks, sweetened~     with sugar or with non-caloric sweeteners, over the insulin response of healthy adults who~     normally consumed foods or drinks that contain non-caloric sweeteners~   "
51708|NCT02890095|"~     Exposure to certain classes of chemical contaminants, including certain persistent organic~     pollutants (POPs) with a character of endocrine disruptors, could be one of the factors that~     lead to increase incidence of breast cancer in the Western world .~      However, the causal role of POPs in the onset of breast cancer remains nowadays unproven.~     Preliminary epidemiological studies on the impact of these environmental factors in breast~     cancer etiology have ignored the critical periods of exposure. Similarly, they have~     considered a limited number of pollutants (not including possible joint or synergistic~     effects between individual compounds) and did not distinguish the different breast cancer~     subtypes may have different etiologies or even of genetic susceptibility factors (POP~     polymorphism of detoxification enzymes).~      Thus, POPCASE study examines the association between the presence of breast cancer and the~     levels and exposure profiles to a group of POPs measured in adipose tissue (AT) and blood, in~     particular using spectrometric methods developed by the team LABERCA (Nantes, France). These~     internal levels of POPs (organochlorine pesticides, dioxins, PCBs, brominated flame~     retardants) will be measured both quantitatively (tissue concentrations) and qualitative~     (relative proportions of different pollutants sought).~   "
51709|NCT02890082|"~     The rates of patients with spontaneous pregnancies reported after breast cancer is between 3~     and 7%, particularly because of these treatments.~      Therefore, it is essential to anticipate this problem by proposing the use of fertility~     preservation techniques for these young patients prior to any gonadotoxic treatment.~      PRESAGE study offers to patients fewer than 40, to preserve their fertility before~     neoadjuvant or adjuvant chemotherapy for invasive breast cancer.~      The aim of this study is to evaluate the feasibility of ovarian stimulation emergency order~     not to delay the start of treatment. This stimulation combined gonadotropin and tamoxifen~     followed by an oocyte retrieval. The patient may receive an oocyte vitrification and / or~     embryonic.~      This procedure is already done in many countries, and by some French teams, by combining~     tamoxifen or letrozole to the classic gonadotropin stimulation.~   "
51710|NCT02890069|"~     The purpose of this study is to combine the PDR001 checkpoint inhibitor with several agents~     with immunomodulatory activity to identify the doses and schedule for combination therapy and~     to preliminarily assess the safety, tolerability, pharmacological and clinical activity of~     these combinations.~   "
51711|NCT02890056|"~     The purpose of this study is to determine the efficacy of a community-based behavioral~     intervention (H2GO!) on decreasing sugar-sweetened beverage consumption and promoting water~     consumption among school-aged youth and parents/caregivers. We hypothesize that participants~     in the intervention site will demonstrate reduced sugar-sweetened beverage intake intake and~     increased water intake compared to participants in the comparison site at 2 and 6 months~     follow-up.~   "
51712|NCT02890043|"~     The object of this study was to evaluate the accuracy and safety of the Tirobot system.~   "
51713|NCT02890030|"~     The patients enrolled on this new study will serve as an appropriate comparison group~     consisting of patients with the diagnosis of germ cell testicular cancer who were cured with~     surgical resection and did not receive cisplatin-based chemotherapy with a group of patients~     from another study who did receive cisplatin-based chemotherapy.~   "
51714|NCT02890017|"~     This is a medico-economic study of outpatient surgery paired with a night stay in a~     patient-hotel, compared with a conventional hospitalization for three types of urological~     surgeries.~      The aim is to show that those two strategies are not different in term of adverse effects or~     rehospitalization, and that the patient-hotel provide a better quality of life at a reduced~     cost, in order to generate savings for the paying agent: the Healthcare insurance.~   "
51715|NCT02890004|"~     This prospective, observational study aim to identify :~        -  Prognostic factor of patients with subarachnoid haemorrhage in neuro intensive care unit~        -  The impact of standard therapeutic used (surgery, embolization ; medical treatment of~          vasospasm ; treatment of complications like hyponatremia, stress myocardiopathy, …)~   "
51716|NCT02889991|"~     This study evaluates the deep dry needling technique as a percutaneous technique included in~     the professional field of physiotherapy.~      The project quantifies a significant limit on the number of local twitch responses necessary~     for the favorable treatment of myofascial pain and analyzes the injury degree and/or the~     repair of myofascial tissue, with Elastography.~   "
51717|NCT02889978|"~     GRAIL is using deep sequencing of circulating cell-free nucleic acids (cfNAs) to develop~     assays to detect cancer early in blood. The purpose of this study is to collect biological~     samples from donors with a new diagnosis of cancer (blood and tumor tissue) and from donors~     who do not have a diagnosis of cancer (blood) in order to characterize the population~     heterogeneity in cancer and non-cancer subjects and to develop models for distinguishing~     cancer from non-cancer.~   "
51741|NCT02889666|"~     The purpose of this study is to determine if the commonly administered chemotherapeutic~     agents including cisplatin, carboplatin, oxaliplatin, docetaxel and gemcitabine for solid~     tumors in clinical oncology, either a single format or given as combinations followed by~     surgery are effective in the treatment of relapsed and refractory non-small cell lung cancer~     patients.~   "
51718|NCT02889965|"~     OFSEP is an observational cohort of Multiple Sclerosis (MS) and related disorders set up in~     France. It aims to provide a major epidemiological tool on MS for the scientific community in~     France and abroad. This tool must help to answer a large number of questions concerning the~     causes and mechanisms of MS, the prognostic factors of disease progression, the effectiveness~     and safety of therapeutic drugs, the impact of the disease on patients and society, etc.~      In December 2015, it has already included more than 54.000 patients. To achieve this goal,~     OFSEP's objectives are~        -  To maintain and develop the French cohort of patients suffering from MS or related~          diseases and syndromes. This means collecting standardized socio-demographic and~          clinical data as part of the routine medical follow-up of patients already in the cohort~          and recruitment of new patients.~        -  To supplement the existing clinical data with standardized and quality biological~          samples and MRI scans.~        -  To improve the previous data with medical/administrative data from the health insurance~          fund databases in particular, in order to get more information on comorbidity, treatment~          protocols and the medico-economic aspects of this disease.~        -  To use OFSEP infrastructures to facilitate the implementation of specific studies~          requiring the collection of additional data or specific patient monitoring processes.~        -  To ensure the availability of these data and samples to researchers, health care~          authorities and industrial players to enable analysis and thus provide answers to~          research questions or public health issues. This availability is only possible after~          scientific and regulatory evaluation of the request.~        -  To provide regular descriptions of the patient population in the cohort to offer~          statistics, targets and up-to-date information on this disease and thus enable a better~          approach to the personal, professional and social impacts of the illness, the effects of~          basic treatments and the requirements related to the follow-up of this disease in~          France.~        -  To conduct specific studies on the entire population of patients in the cohort (parent~          cohort) or on patient sub-groups with specific characteristics (nested cohorts). Four~          nested cohorts have been defined: patients with radiologically isolated syndromes,~          patients with clinically isolated syndromes, patients with primary progressive courses~          of the disease and patients with neuromyelitis optica (Devic's syndrome) spectrum~          disorders.~   "
51719|NCT02889952|"~     This Before-and-after Controlled Study study evaluates the clinical impact of parathyroid~     autofluorescence visualization using near infrared light (NIR) during total thyroidectomy~     (TT).~      It compares two groups of consecutive patients who underwent TT associated or not to lymph~     node dissection (LND) with and without intraoperative use of NIR, by the same surgeon.~   "
51720|NCT02889939|"~     The aim of this project is to investigate whether it is possible to improve the functioning~     and activity level for individuals more than 6 months after stroke by partaking in a~     rehabilitation program consisting of high-intensity task-specific, goal-directed training in~     an enriched environment.~   "
51721|NCT02889926|"~     Leg ulcers are defined as wounds lasting for more than a month. They would receive 0.2% of~     the population of Western countries. In Europe, the cost per episode of leg ulcers is~     estimated at 6650 euros (10 000 euros for a foot ulcer). The cost of treatment of wounds~     would be 2 to 4% of the health budget. Infection is the most common complication of chronic~     wounds: in most cases, it results in delayed healing, at most, it can result in amputation or~     serious general complications Bacterial contamination of ulcers is constant. Over time for~     over 25 years, various studies have shown about relatively identical results. The bacteria~     are present in over 90% of the etiology of venous leg ulcers. These bacteria are divided into~     four most common classes: Staphylococcus aureus, Enterococcus, Streptococcus, Pseudomonas.~     The bacterial ecology changes over time. Indeed Staphylococcus aureus appears first, while~     the Pseudomonas is associated with ulcers lasting for several months. Anaerobic more~     difficult to find, are found in 30% of cases Cohabitation between leg ulcers and bacteria~     often without clinical consequence: These are the stages of infection and colonization.~      The infection is related to the proliferation of bacteria and their invasion into the skin,~     by increasing their virulence (virulence genes acquisition). The increase in the number of~     bacteria and the multiplicity of bacterial genera are one reason for the increased virulence~     of bacteria. When bacteria proliferate, because the host defenses are inadequate, or because~     there is a vascular disease which promotes the proliferation, clinical signs appear~   "
51722|NCT02889913|"~     Leg ulcers are frequent. There are no epidemiological studies available in France, but~     international studies estimate the prevalence between 0.045 and 0.63% of the total~     population, prevalence increases with age, reaching 5% of patients over 80 years.~     Extrapolating these prevalences in the French population between 28 000 and 395 000 people~     are affected in France a leg ulcer.~      It is a costly disease. In 2001, a French study conducted among 800 physicians, including~     85.7% of general practitioners, involving more than 1000 patients with venous ulcers, it was~     estimated that the total cost of treatment per patient average was 888 32 euros. This is~     truly a public health problem.~      Leg ulcers are in 80% of cases of vascular causes (venous, arterial or arteriovenous mixed).~     However, there are rare causes of ulcers: skin carcinoma, infectious ulcers and vasculitis.~     These ulcers rare causes require specific treatments that can often heal. To diagnose, to~     perform a skin biopsy. Thus, the general practitioner must know when to put the indication~     for biopsy of a leg ulcer.~   "
51723|NCT02889900|"~     This is an open label, single arm, multi-center study to assess the efficacy and safety of~     the combination of cediranib and olaparib tablets in platinum-resistant relapsed high grade~     serous, high grade endometroid or clear cell ovarian, fallopian tube or primary peritoneal~     carcinoma patients who have received at least 3 prior lines of chemotherapy and who do not~     carry deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA)~     mutations.~   "
51724|NCT02889887|"~     The aim of this study is to analyse correlation between the sensory processing and motor~     development in preterm infants.~   "
51725|NCT02889874|"~     This is a randomised, phase III, non-inferiority trial evaluating radiation therapy versus~     observation following breast conserving surgery and planned endocrine therapy in patients~     with stage I breast cancer of luminal A subtype defined using the Prosigna (PAM50) Assay.~   "
51726|NCT02889861|"~     IMCgp100-401 is a rollover study that is designed to provide continued access to IMCgp100 for~     eligible patients with advanced melanoma who have previously participated in an IMCgp100~     study (parent study).~   "
51727|NCT02889848|"~     This pilot study evaluates the safety and tolerability of a single injection of collagenase~     enzyme directly into a uterine fibroid in subjects already selected for hysterectomy or~     myomectomy.~      Fibroids contain excessive amounts of collagen and it is possible that digestion of collagen~     may be beneficial in reducing pain and bleeding associated with fibroids.~      Three subjects will be injected with saline only to evaluate the safety and effectiveness of~     the injection method. Additional subjects will then be injected with increasing doses of~     study drug.~   "
51728|NCT02889835|"~     This study will examine the clinical performance of Class II restorations over a three year~     period with 3 composite resins - a conventional composite resin, a flowable composite resin~     and a bulk placed and cured composite resin.~   "
51742|NCT02889653|"~     The purpose of this study is to determine the incidence and severity of bleeding~     complications in patients with cerebrovascular and cardiovascular diseases treated with oral~     antithrombotic therapy.~   "
51730|NCT02889809|"~     There is a regulatory requirement to evaluate the extent of reduction (if any) of growth~     velocity associated with inhaled corticosteroid (ICS) containing products that are to be~     administered to children, and to this end there is Food and Drug Administration (FDA)~     regulatory guidance. This is a randomised, single-blind (run-in period)/double-blind~     (treatment period), parallel group, placebo controlled, multicentre study to assess the~     effect of once daily (OD) inhaled fluticasone furoate (FF) 50 microgram (mcg) on growth~     velocity in prepubertal asthmatic children on a background therapy of open-label montelukast.~     This study will be conducted over a total duration of approximately 76 weeks: 16-week run-in~     period (single-blind placebo inhaler), 52-week double-blind treatment period (inhaled FF 50~     mcg /placebo administered OD in the morning for 52 weeks) and 8-week follow-up period. The~     purpose of the study is to evaluate the magnitude of effect (with a level of precision) on~     growth velocity of prepubertal asthmatic paediatric subjects (aged 5 to <9 years) following~     administration of OD inhaled FF 50 mcg for one year. This study fulfills European Union (EU)~     and United States (US) regulatory requirements for the evaluation of potential growth~     suppression in children.~   "
51731|NCT02889796|"~     The primary objective of this study is to evaluate the effects of filgotinib versus placebo~     in adults with active rheumatoid arthritis (RA) who have an inadequate response to~     methotrexate (MTX).~   "
51732|NCT02889783|"~     This is a routine evaluation of urethral sensation during urodynamic studies. The record has~     been realized retrospectively. The investigators propose a new way to represent urethral~     sensation, in a simple and non-invasive way.~   "
51733|NCT02889770|"~     This studies´ objective is to describe how different PEEP levels affect dead space measured~     by Bohr´s formula.~   "
51734|NCT02889757|"~     Animal studies have shown that INH-RIF-induced oxidative injury can be prevented by~     supporting the cellular antioxidant defense mechanism by N-acetylcysteine (NAC). However,~     there are few published data and large sample sizes regarding the protective effect of NAC~     against hepatotoxicty induced by anti-TB drugs in humans, to our knowledge.~      Therefore, the investigators designed a clinical trial with the aim to see whether NAC could~     protect against anti-TB drug-induced hepatotoxicity (DIH)~   "
51735|NCT02889744|"~     The investigators hypothesize that~        1. if decrease in SctO2 level is caused by the degree of hypothermia, SctO2 level in the~          33-TH may be lower than that in the 36-TH group.~        2. if decrease in SctO2 level is not caused by the degree of hypothermia but caused by~          brain injury, SctO2 level may be associated with only the prognosis of cardiac arrest~          victims regardless of core temperatures.~      The primary objective of this study is to compare the 72-hour changes in SctO2 level between~     the 36-TH and 33-TH groups in cardiac arrest victims.~   "
51736|NCT02889731|"~     Background: Suicides by jumping from the high buildings of acute hospitals are dramatic~     events which are highly traumatizing to families, staff and fellow pts. In the 10 years~     from1995 to 2010 the investigators have counted 10 suicide cases despite extensive measures~     taken to predict and avoid them.~      The investigators hypothesized that constructive measures at the windows that would render~     access more difficult could discourage spontaneous suicidal behaviour and would reduce the~     suicide rates.~      Intervention: Starting in 6/2004, a 20 mm diameter metal guard-rail (which resists 250kg) was~     installed at each window of a 360 bed acute hospital at a height of 113cm, 18cm above the~     window parapet with the aim to visually, psychologically and physically discourage potential~     suicidal impulses.~   "
51737|NCT02889718|"~     This is a feasibility study of anesthesia in closed loop with the CONCERT-CL® station, on the~     effect of the hypnotic agent, measured by the bispectral index of the electroencephalogram,~     to maintain the hypnosis level within the recommended limits for general anesthesia. The~     analgesic agent is administered in Target-Controlled Infusion = TCI and analgesia evaluated~     by pupillometry.~      This is a prospective, open, non-controlled, non-randomized, monocentric study. The main~     objective is to study the potential contribution of the system in the conduct of anaesthesia,~     as decision support, for the administration of the hypnotic agent.~      Secondary objectives will include hemodynamic stability, and the average concentrations of~     opioid and hypnotic anesthetic agents evaluated from the pharmacokinetic model.~      The study will involve surgical patients scheduled for surgery under general anesthesia for~     more than 1 (one) hour.~   "
51738|NCT02889705|"~     Objective: To document the sternocleidomastoid (SCM) muscle fibrosis in congenital muscular~     torticollis (CMT) infants with quantified echotexture and measured thickness during the~     treatment course.~      Design: Cohort study. Setting: Rehabilitation department in a tertiary care hospital.~     Participants: Infants with clinical diagnosis of CMT, without any neurological presentation,~     cervical spin abnormality, and developmental dysplastic hip problem, were recruited in the~     study.~      Intervention: All subjects had physiotherapy for at least 3 months. They underwent at least~     two times of clinical assessment and ultrasonographic examination (1) for bilateral SCM~     muscles during the follow-up period.~      End of follow-up: Subjects who still had prominent clinical presentations after physiotherapy~     for 6 months or were older than 1 year would receive surgery. Subsided presenting clinical~     features determined by the clinician was the other end-point of this investigation.~      Main Outcome Measures: The K value, derived from the difference of echo intensities (2)~     between the involved and uninvolved SCM muscles on longitudinal sonograms, was used to~     represent the severity of muscle fibrosis in CMT infants. Bilateral SCM muscle thickness and~     involved-to-uninvolved thickness ratio (Ratio I/U) were also obtained from longitudinal~     sonograms. Clinical outcome was also recorded.~   "
51739|NCT02889692|"~     The investigators performed a randomized, double blind controlled, prospective study method~     on observation of Traditional Chinese Medicine (TCM) combined with targeted therapy~     maintenance to prolong the efficacy of long-term survival of advanced pulmonary~     adenocarcinoma patients. The investigators plan to involve 200 cases for observation in 3~     years (100 cases for targeted therapy maintenance, 100 cases for targeted therapy maintenance~     plus TCM,), expecting that integrated TCM combined with targeted maintenance therapy has a~     better efficacy on prolonging progression-free survival time, overall survival, improving~     quality of life(QOL) of patients than that of targeted maintenance therapy.~   "
51740|NCT02889679|"~     The aim of this study is to compare the efficacy of underwater resection (polypectomy) versus~     conventional polypectomy techniques for small and large colorectal lesions identified during~     colonoscopy.~   "
51743|NCT02889640|"~     The inability to consistently deliver at large scale promising education interventions is one~     of the most important contributing causes to inequality in the U.S. The research team applies~     insights from price theory and field-based randomized controlled trials to examine the effect~     of implementing a promising academic skills development program at large scale before~     implementing at scale. The project is designed to provide evidence of direct scientific and~     policy value for attempts to scale up a specific intervention, but also stimulate much more~     investigation of social policy scale-up challenges by refining these methods and~     demonstrating their feasibility and value.~      The research team examines the challenge of program scale up for a promising intervention~     studied in Chicago at medium scale in the past - SAGA tutoring. Past work has demonstrated~     that SAGA's intensive individualized, during-the-school-day math tutoring can generate very~     large gains in academic outcomes in a short period, even among students who are many years~     behind grade level. This study will explicitly explore the extent to which there is a~     trade-off between effectiveness and scale for this intervention. By taking advantage of the~     power of random sampling, this study will also allow for observation of the program's~     effectiveness as if it were running at three-and-a-half times the proposed scale in a subset~     of the study population.~   "
51744|NCT02889627|"~     Increasing evidences showed the microbiota effects on neuropsychiatric disorders. This~     clinical trial aims to evaluate the efficacy and safety of fecal microbiota transplantation~     for epilepsy.~   "
51745|NCT02889614|"~     Familial hypobetalipoproteinemia (FHBL, OMIM # 1707730) is a genetic disorder heterozygotic~     of LDL-C metabolism. Clinical manifestation range from asymptomatic patients to metabolic~     (fatty liver, diabetes) or psychiatric disorders still unrecognized. HYPOPSY research, aims~     to evaluate prevalence of hypobetalipoproteinemia, and to characterize specific related~     psychiatric disorders.~   "
51746|NCT02889601|"~     Psycho-behavioral disorders assessment is crucial for the diagnosis and follow-up of patients~     with frontotemporal degeneration (FTD). DAPHNE scientific staff have therefore developed a~     quantification and follow-up scale specifically dedicated to patients with FTD in current~     clinical practice. This scale is called DAPHNE to Disinhibition, Apathy, Perseveration, Hyper~     orality, Negligence and loss of Empathy.~   "
51747|NCT02889588|"~     Refractive surgery includes interventions to correct refractive errors, using a medical~     device such as a laser or an implant (intraocular lenses) or surgical instruments. The study~     distinguishes corneal interventions, carried on the surface of the eye, and intraocular~     interventions, performed on the lens or in the anterior or posterior chamber of the eye. The~     number of procedures in refractive surgery is growing significantly. They seem to offer~     satisfactory visual results but a number of issues remains unresolved. In order to get~     emmetropia, refractive surgery corrects optical defects by decreasing aberrations of lower~     orders (ie spherical refractive error and astigmatism). This increases high-order aberrations~     (the most common is a bright halo on the edge of the image). The cutting of the flap to the~     surface of the cornea in the case of LASIK increases high-order aberrations, which have the~     effect of reducing post-surgical visual performance (ie visual acuity and contrast~     sensitivity) and can't be corrected by glasses, while the adaptation of contact lenses on a~     post-operative cornea is more complex. It is therefore necessary to limit these post-surgical~     aberrations and to identify their possible sources. Indeed, some authors have provided~     insight into the effects of some high-order aberrations, but the influence of several factors~     characterizing the preoperative eye on refractive surgery are still unknown, such as~     pupillary diameter, depth of the anterior chamber, Intra Ocular Pressure or astigmatism.~   "
51748|NCT02889575|"~     Acute Renal Failure (ARF) is defined by a severe, and usually reversible, glomerular~     filtration rate decreasing. Acute Tubular Necrosis (ATN) remain the major cause of ARF~     involving distress and destruction of tubular cells. This specific typology of ARF may evolve~     toward Chronic Renal Failure (CRF) concretizing a major public health issue.~      Predict the progression of ARF towards CRF appears essential. The investigators believe that~     the PIIINP and urinary NGAL biomarkers may constitute robust biomarkers of progression risk~     towards CRF.~   "
51749|NCT02889562|"~     In this open-label, prospective, randomized pilot study, patients who develop atrial~     fibrillation after isolated coronary artery bypass grafting surgery will be identified.~     Patients with persistent atrial fibrillation (>12 hours) or recurrent sustained atrial~     fibrillation (>2 episodes of atrial fibrillation lasting longer than 30 minutes) will be~     candidates for inclusion. Upon meeting study inclusion and exclusion criteria, and after~     informed consent, patients will be randomized to either the standard of care (warfarin per~     protocol) or apixaban arms of the trial. Routine postoperative care after CABG will occur in~     both groups. Upon discharge, anticoagulation in both groups will be managed by the~     anticoagulation clinic. Patients will be followed for 30 days after surgery.~   "
51750|NCT02889549|"~     Ticagrelor is an oral, reversibly-binding, direct-acting P2Y12 receptor antagonist used~     clinically for the prevention of atherothrombotic events in patients with acute coronary~     syndromes (ACS). Guideline recommendations on the use of dual antiplatelet therapy have been~     formulated that ticagrelor 90 mg twice daily plus aspirin in preference to clopidogrel 75mg~     daily plus aspirin for ACS patients. However, few East Asian patients have been included in~     these trials to assess the use of these drugs. In addition, a growing body of data supported~     that East Asian might have different adverse event profiles (thrombophilia and bleeding) and~     therapeutic window compared with white subjects. But it is still not clear whether a low~     dose of ticagrelor is superior to clopidogrel in diabetic patients with stable coronary~     disease.~      Recent studies found that antiplatelet drugs might have anti-inflammatory effects and protect~     endothelial function. ACS patients treated by ticagrelor had a significantly higher increase~     in levels of circulating progenitor cells compared to those treated by clopidogrel,~     suggesting a benefit on endothelial regeneration that may participate in the pleiotropic~     property of the drug. This may prompt the regression of blood vessels and the endothelium~     stability. But it is not very clear that the effect of low-dose ticagrelor on vascular~     endothelial function in diabetic patients with stable coronary artery disease.~      Therefore, the investigators performed this randomized, single-blind clinical trial to~     observe the effects of different doses of ticagrelor and standard-dose clopidogrel on~     platelet aggregation and endothelial function in diabetic patients with stable coronary~     artery disease.~   "
73637|NCT02603042|"~     Development of a new MS-based biomarker for the early and sensitive diagnosis of~     Hypophosphatasia disease from plasma~   "
51751|NCT02889536|"~     A parastomal bulge (PB) is a frequent long-term complication after stoma formation. Most~     parastomal bulging occurs within two years of stoma formation but is seen up to 20 years~     post-surgery. A bulge may be relatively obvious or extremely difficult to diagnose, and~     descriptions of symptoms vary from 'asymptomatic', 'symptomatic' to 'high symptom load'.~     Previous studies report that quality of life as well as physical, psychological and social~     function are affected in patients with parastomal bulging. However, there is a lack of~     knowledge of patients' lived experiences with parastomal bulging. Insight into patients'~     experiences of symptoms in relation to parastomal bulging and the impact on everyday life may~     help identify issues of importance from the patient perspective. This, in turn, may help~     professionals to better understand and support patients with PB, and be of help when~     identifying patients' symptoms and determining relevant treatment strategies.~   "
51752|NCT02889523|"~     Phase I of the study is designed to determine the recommended phase II dose (RP2D) for~     tazemetostat in patients treated with R-CHOP 21.~      Phase II of the study is designed to determine the safety of tazemetostat in patients treated~     with 8 cycles of R-CHOP 21 and to determine the complete response rate according to Cheson~     International Working Group (IWG) 2014: Lugano Classification (i.e. Deauville scale 1-3)~     after 8 cycles of Epi-RCHOP 21.~   "
51753|NCT02889510|"~     Type 2 diabetes (T2DM) is related to reduced pulmonary function. As experimental studies with~     glucagon-like peptide 1 (GLP-1) have shown an increase in pulmonary surfactant secretion, and~     the GLP-1 receptor has been found in significant amounts in the lung, it could be~     hypothesized that the treatment with liraglutide (a GL-1 agonist) will improve this reduced~     pulmonary function~   "
51754|NCT02889497|"~     This study evaluates the safety,three batches consistency and immunity duration of the~     post-marketing inactivated Enterovirus Type 71 (EV71) vaccine in children aged 6-71~     months.This study has two groups:safety observation group and immunogenicity observation~     group.20000 subjects will receive 2 doses vaccines and be observed for safety among 2~     epidemic cycles of HFMD.In the immunogenicity observation group, 900 subjects will be~     randomly received 3 batches vaccines(2 doses),and blood sampled at days 0 and 56.~   "
51755|NCT02889484|"~     Purpose: The incidence of surgery for lumbar disc hernia varies. According to the national~     spine registries in Sweden, Norway and Denmark, there is a 30-60% difference in surgical~     incidence between these countries. The cause for this difference is not known. It may reflect~     a difference in incidence of lumbar disc hernia, but with a similar socio-economic and~     ethnical background in these countries, it is more likely that the differences are due to~     varying surgical indications. Comparing indications for surgery, patient reported outcome and~     factors predictive for outcome after surgery for lumbar disc hernia in these countries could~     provide information about optimal indications for surgery.~      Hypotheses: (i) there are no differences in patient-reported outcome after surgery between~     these countries, (ii) there are no differences in indications for surgery between these~     countries and (iii), factors that predict outcome are similar in these countries.~      Method of research: By using data from three Nordic national spine registers, we will compare~     baseline data, indications for surgery and patient reported outcome one year after surgery~     for lumbar disc herniation. Register based studies have advantages such as large sample~     sizes, reflecting real life, but they also have limitations such as lower follow-up rates~     than clinical trials. A non-response analysis will be performed to take this into account.~   "
51756|NCT02889471|"~     110 patients with common bile duct (CBD) stones and had one or more anther preoperative~     predictors for high risk for difficult cholecystectomy admitted to departement of surgery of~     Minia university hospital for ERCP then laparoscopic cholecystectomy (LC). the patient~     divided into 2 equal group. in group 1, nasobiliary (NB) catheter was inserted during ERCP~     after CBD clearance. In group 2, only CBD clearance was done. In all patients LC was done~     within the same week of ERCP. Tans-nasobiliary Intraoperative cholangiography was done and~     methylene blue injected at the end of the procedure to detected any leak in NB group~   "
51757|NCT02889458|"~     Introduction: With population ageing and increasing Westernization breast cancer continues to~     be important health conditions among women in Hong Kong. Greater collaborative research~     efforts are needed to examine the questions about population screening for breast cancer, the~     aetiology of such lesions and outcomes of breast cancer during survivorship period. There is~     a lack of locally-relevant models for assessing breast cancer risk. Contribution of novel~     genetic factors to breast cancer, identification of the key and functional alleles in gene~     regions associated with risk of breast cancer as well as gene-environment interaction,~     requires further investigation in Chinese population. Prognostic research studies in the West~     may not be readily applicable to the Chinese population.~      Objectives: We aim to investigate the aetiology and outcomes of breast cancer in local~     Chinese by using case-control and cohort study design in the health care setting in Hong~     Kong. We aim to examine potential risk factors/biomarkers (both traditional and novel), and~     to build infrastructure and biobank for breast cancer surveillance. We will follow up cases~     prospectively as a survivor cohort.~      Methods: A hospital-based case-control study and a prospective survivor cohort study will be~     conducted. Consecutive incident breast cancer and DCIS cases (n=3,500) within a 24-month~     period in Hong Kong will be recruited from public hospitals, private hospitals and private~     practices; and controls will be selected by frequency-matching on factors such as age and~     hospital/clinic setting. Cases will be prospectively followed up over a 2-year period, and~     data collection will occur at baseline (within 24 weeks of diagnosis), 6 months, 1 and 2~     years following baseline assessment. Biologic samples (including both blood, and tumour and~     normal breast tissue samples from the cases, and blood samples from the controls) will be~     collected for later genetic and molecular study including WGS, GWAS, gene-environment~     interaction and molecular functional studies. Depending on availability of pathology samples~     and resources, additional studies such as tissue microarray block production will be~     considered and performed in future. Data will be analysed by traditional regression, EWAS and~     genetic association methods, whenever relevant.~      Public Health Implications: The repository of clinical, radiological and biological materials~     assembled through this case-control study will serve as a common, publicly accessible~     platform for subsequent functional analysis and scientific interrogation. The case-control~     findings would offer an improved understanding to the state of the science on aetiology of~     breast cancer in Chinese women. In the genomics analysis, potential refined classification of~     breast tumours may enhance our understanding, detection and follow-up of such lesions, as~     well as enable us to have more informed targeted and personalized treatment selection for our~     women population. The cohort study findings are important for developing an effective~     strategy for the improvement of overall survival and quality of life for the cancer survivors~     in Chinese population.~   "
51758|NCT02889445|"~     4-Demethyl-4-cholesteryloxycarbonylpenclomedine (DM-CHOC-PEN) is a polychlorinated pyridyl~     cholesterol carbonate that is lipophilic, electrically neural, crosses the blood brain~     barrier (BBB), ability to localize in intracranial tumor tissue, lacks neurotoxicity and not~     transported out of the brain via Pgp (p-glycoprotein) (1). DM-CHOC-PEN has completed Phase~     I/II trials in humans with primary and secondary tumors involving the brain with success.~     Complete remissions in both primary (astrocytomas, GBM) and metastatic lung cancers.~      This trial is open for adolescent and young adults (AYA) subjects with advanced cancer -~     brain involvement is not required.~   "
52061|NCT02885467|"~     This is a randomized study investigating whether identification, ligation, and burial of~     superficial branches of the saphenous nerve crossing the surgical field during total knee~     arthroplasty reduces the rate of post-operative anterior knee pain and neuralgia compared to~     standard total knee arthroplasty.~   "
51759|NCT02889432|"~     Orthognathic surgery is commonly performed for the treatment of dentofacial deformities. Yet,~     one of the most prevalent and long-term complication encountered is neurosensory disturbance~     thus impairing sensation to parts of the face. In Hong Kong, it has been reported that in~     patients receiving orthognathic surgery, 5.9% experience long-term neurosensory disturbance~     post-surgery.~      Melatonin is a neurohormone that is produced and secreted by the pineal gland in the brain.~     Its main physiological role in humans is to regulate sleep. Oral Melatonin supplements is~     also used in the management of jetlag and other sleep disorders. Recently, animal and human~     studies have shown Melatonin to improve tolerance to pain and to have a neuroprotective and~     neuroregenerative effect after nerve injuries.~      Hence, it is hypothesized that peri-surgical oral Melatonin supplement can improve~     neurosensory recovery after orthognathic surgery~   "
51760|NCT02889419|"~     KML is a multicenter, prospective, uncontrolled and before/after study. The study aims to~     estimate if the use of Selfia ® adapted underwear reduces the necessary duration for the~     realization of self-catheterisation (SC) for patients affected by multiple sclerosis with~     severe to moderate disability.~      Secondly, the study aims to :~        -  Estimate the effect of underwear on quality of life, tiredness linked to the act,~          comfort in the realization of SC, complications with SC, third party intervention ;~        -  Collect patients' opinion on the use of the underwear SELFIA ® at the end of the 2nd~          week of evaluation ;~        -  Measure if the patient reused underwear and if he bought it at 6 months and at 1 year~   "
51761|NCT02889406|"~     In a recent study, we have demonstrated that the motivational therapy approach to treat~     childhood obesity is highly effective at clinical and metabolic levels. This efficacy has~     been proved in a clinical outpatient setting. However, a standardized collaborative approach~     between the clinic and the primary care services would allow a faster and easier approach to~     childhood obesity treatment. Furthermore, this motivational and educational intervention~     would benefit from the current technologic facilities, the long term effect of the education~     at group level, in terms of food shopping plan, healthy, fast and cheap cooking methods that~     would be useful specially in low income families (with a higher prevalence of childhood~     obesity).~      The aim of this study is assessing the clinical and metabolic efficacy of a family~     intervention, coordinated between the clinical and primary care services from the Tarragona~     health-care region, using a motivational therapy at individual and group levels, which~     involves e-Health tools (wearable), focusing on families with an 8 to 13 years old obese~     child.~      The design will be a clustered randomized control trial, with an intervention group that will~     receive a multicomponent motivational and educational plan which will be compared to a~     control group receiving the usual recommendations performed in primary care centres (n=167~     per group). The treatment of both study groups will last 12 months and will be performed at~     the primary care centres. In parallel, the study team will validate the methodology used to~     assess body composition in obese children as well as the changes produced by the~     intervention.~   "
51762|NCT02889393|"~     The purpose of this study is to determine whether teduglutide is safe and feasible to be~     given for the treatment of enterocutaneous fistula (ECF). We hypothesize that the drug will~     be well-tolerated and will improve the volume of daily ECF output as well as improve the~     functional quality of life.~   "
51763|NCT02889380|"~     This is a multicenter retrospective study in good prognosis Chinese patients. Data will be~     collected from infertile women who underwent first in vitro fertilization (IVF)/intra~     cytoplasmic sperm injection (ICSI) using a Gonadotropin releasing hormone (GnRH) antagonist~     (Cetrotide) protocol at about 4 IVF centers to investigate the factors associated with~     clinical pregnancy rate. The definition of the good prognosis subjects is, age not more than~     35 years old, Baseline serum Follicle-stimulating hormone (FSH) level no more than 10~     milliinternational units (mIU)/milliliter (ml), Body mass index (BMI) not more than 30~     kilogram per meter square (kg/m^2), previously underwent no more than 3 IVF/ICSI cycles, and~     the total dose of Gonadotropin used no more than 2500 IU in current cycle. No intervention(s)~     will be administered on the subjects. Data required to investigate the factors associated~     with the pregnancy outcome of GnRH antagonist IVF cycle will be collected from the subjects'~     medical records into database through electronic data capture system and analyzed.~   "
51764|NCT02889367|"~     The purpose of this study is to determine the relationship between the plasma concentrations~     of odalasvir and changes in the QT interval / QTc interval (QT corrected for heart rate)~     using exposure-response (ER) analysis.~   "
51765|NCT02889354|"~     The newly developed CBT for ADHD inattentive-type (ADHD-I) protocol is tested for feasibility~     and acceptability in a pilot study with a single group design. The study also evaluates~     measurements and recruiting possibilities, and effects of the intervention. Research~     hypotheses include: 1. There is a basis for recruiting ADHD-I patients for participation in~     an RCT at psychiatric outpatient units, 2. The measurements in the study are feasible and~     reasonable in regards to patient characteristics; that is, the patients are responding to the~     questionnaires as intended, 3. The CBT for ADHD-I intervention is feasible in terms of~     treatment completion, compliance to home assignments, and credibility and relevance, and is~     lacking of or involves a tolerable degree of adverse effects, and 4. The CBT for ADHD-I~     protocol reduces core symptoms of ADHD-I as well as symptoms of stress, depression, and~     anxiety, and improves quality of life.~   "
51766|NCT02889341|"~     Sperm parameters will be examined before DHA (DHA=Docosahexanoic Acid) consumption, after one~     months and after 2 months taken Docosahexanoic Acid or placebo.~   "
51767|NCT02889328|"~     Randomized, placebo-controlled, phase III study of regorafenib 160 mg once daily on~     intermittent dosing schedule of 3 weeks on treatment followed by 1 weeks off demonstrated the~     significant benefit of regorafenib in terms of PFS in patients with GISTs who had failed to~     both imatinib and sunitinib. However, there are concerns that tumors and tumor-related~     symptoms may be progressed during off treatment period. Investigators hypothesize that~     continuous dosing schedule of regorafenib might be feasible and effective to prevent disease~     flare on off-treatment period. Based on the results of previous dose escalation study for~     continuous regorafenib dosing, we investigate the 100 mg daily dose of regorafenib in~     patients with TKI-refractory GISTs.~   "
52062|NCT02885454|"~     The purpose of this study is to evaluate the effect of steady-state concentrations of~     odalasvir (ODV), AL-335 and the combination of the 3-direct-acting anti-viral agents (3-DAA)~     ODV, AL-335, and simeprevir (SMV) on the single-dose pharmacokinetic (PK) of drospirenone and~     ethinylestradiol in healthy female participants.~   "
51768|NCT02889315|"~     Subcutaneous treprostinil is used to treat pulmonary arterial hypertension (PAH). Due to~     local pain it causes a deterioration of quality of life or even abandonment of treatment. The~     aim of this study was to evaluate the safety and quality of life (QoL) in patients treated~     with treprostinil administration using an implantable Lenus Pro® pump. This is a~     observational study involving patients with PAH treated with a subcutaneous infusion of~     treprostinil with intolerable pain at the infusion site, who were therefore referred for pump~     implantation. Clinical evaluation, including QoL assessment with SF-36 questionnaire was~     performed at the time of initiating therapy with treprostinil, before and 2-9 months after~     implantation.~   "
51769|NCT02889302|"~     The purpose of this study is to investigate the superiority of KPS-0373 to placebo, and~     evaluate the safety of KPS-0373 in SCD patients.~   "
51770|NCT02889289|"~     This study will evaluate the potential for improving balance for a single individual with a~     history of traumatic brain injury (TBI). The participant will engage in supervised therapy~     using commercial games on the Xbox Kinect. This study will also evaluate the viability of~     improving cardiovascular fitness using this intervention as well. The investigators~     hypothesize that balance improvements will occur and that using the Xbox Kinect is a viable~     way of improving cardiovascular fitness.~   "
51771|NCT02889276|"~     This study will be the first to examine the effects of a functional resistance exercise~     programme that closely replicates daily activities and their effects on quality of life, body~     composition and functional fitness in cancer survivors. This study will also use a supervised~     and group based exercise setting to help with socialisation and confidence with an aim to~     improve the exercise experience. Eligible participants should be 18-90 years old, been~     treated for colorectal cancer (stages I-IV) in the previous 3 months to five years and with~     no limitations to exercise. The study will include a 12-week exercise period where~     participants will be randomly allocated to the control group or to take part in 32 supervised~     one-hour group exercise sessions involving exercises to target the whole body at a moderate~     intensity which will take place in the Mountbatten Centre, Pyramids Centre, Fareham Leisure~     Centre or Horizons Leisure Centres. Depending on participants' membership status those in the~     control group could use the centre's exercise referral programme, which has a cost attached,~     or they will be encouraged to meet national physical activity recommendations by walking 30~     minutes per day on most days of the week. The only difference between the two groups will be~     the supervised group functional resistance training. At the beginning and end of the 12-week~     study period a number of health-related fitness tests will be performed to assess health~     outcomes, such as resting blood pressure & heart rate, respiratory function, body fat~     measures (body mass index, waist circumference and body fat %), functional performance~     measurements, handgrip strength, a 6 minute walk test and self-efficacy to regulate exercise~     and measures of quality of life questionnaires. Participants will be provided with their own~     results and an overview of the whole study data.~   "
51772|NCT02889263|"~     The problem of rehospitalizations in the US is well documented but poorly understood.~     Although Medicare compares the rates of rehospitalization across the country, we have found~     no comparison of different countries. This is a first attempt to compare rehospitalization in~     the US with France where national health insurance (NHI) provides easy access to primary care~     but, like the US, policymakers struggle to improve coordination between hospitals and~     community-based health care providers.Although France's NHI system with central state~     intervention differs from the United States' tradition of federalism, private health~     insurance and pluralism, policymakers seek to achieve cost savings and to reform the health~     care system. A recent literature review on avoidable rehospitalization of older persons in~     France cited studies on the topic and relied largely on ones from the US. Starting in 2013,~     the Center for Medicare and Medicaid Services' (CMS) 'Hospitals Readmissions Reductions~     Program' withheld up to 1% of regular reimbursements for hospitals with higher than expected~     (by CMS) rates of rehospitalization, within 30 days of discharge, due to heart attacks, heart~     failure and pneumonia. CMS increased this to 2% in 2014, will raise it to 3% in 2015 and may~     subsequently expand the list of conditions for which it will penalize early~     rehospitalizations. Policymakers in France have been reluctant to implement a hospital pay~     for performance system based on a rehospitalization indicator whose validity is a subject of~     considerable controversy. Despite the controversy and differences in approach, a comparison~     of rehospitalizations between the US and France provides a cross-national perspective on a~     timely policy issue facing both countries.~   "
51773|NCT02889250|"~     This is an open label study with a sample size of 6 to develop deep brain stimulation of the~     subcallosal cingulate white matter(SCCWM) for late life depression using an experimental~     medicine approach in which the investigators will program the device based both on 1) a~     neurophysiologic measure of target engagement and 2) safety (defined as lack of~     neuropsychiatric worsening and stable neurocognition).~   "
51774|NCT02889237|"~     This study is designed as a single-blind RCT in 80 postmenopausal women to compare the effect~     of immediate administration of daily calcium supplementation (1000 mg calcium) or two daily~     dosages of calcium + vitamin D (1000 mg calcium + 880 IU vitamin D or 1000 mg calcium + 1760~     IU vitamin D) to standard care (administration of vitamin D3 12 weeks after fracture) in~     terms of calculated bone strength based on analysis of cortical and trabecular bone~     parameters using HR-pQCT, fracture healing and functional outcome.~   "
51775|NCT02889224|"~     Working hypothesis: the interactions between the endogenous endocannabinoïds (ECS) - and~     cortisol, the end product of the Hypothalamo-Pituitary-Adrenal (HPA) axis may play a role in~     the pathophysiology of Cushing's syndrome.~      The investigators speculate that:~        -  acute or chronic variations in plasma cortisol may induce changes in the activity of the~          ECS~        -  that there is a circadian rhythm of the ECS driven by the rythm of plasma cortisol~   "
51776|NCT02889211|"~     The purpose of this study is to help researchers learn about how the brain responds to~     rewards. This study is interested in seeing how these responses differ between people who are~     more and less responsive to insulin in their body, and people with and without depression.~   "
51777|NCT02889198|"~     The purpose of this project is to evaluate the effectiveness of Go NAP SACC (Get online with~     Nutrition and Physical Activity Self-Assessment for Child Care), a suite of web-based tools~     designed to help child care programs improve their nutrition environment (specifically~     classrooms serving 3-5 year olds) over the course of 4 months.~   "
51778|NCT02889185|"~     This study aims to assess the contribution of the multimodal imaging, combining a routine~     examination using Optical Coherence Tomography (OCT) with an imaging procedure using adaptive~     optics retinal camera.~      This is a feasibility study with a limited number of patients.~   "
51779|NCT02889172|"~     The purpose of this study is apply a Brief Intervention (PST) in Diabetic and Obesity patient~     in primary care of Mexico City to improve their depressive and anxious symptoms and~     stabilization of metabolic variables.~   "
51780|NCT02889159|"~     Chronically photodamaged skin is visually characterized by dryness, wrinkles, brown spots,~     leathery appearance, etc. This happens as a result of excessive exposure to UV light from the~     sun. While the sun's exposure leaves the skin's surface visibly changed, the skin's unseen~     immune system may also be permanently altered as a result of the exposure, making it more~     likely to develop a variety of skin cancers and infections. This study will examine the~     lasting changes in the immune system of the skin caused by UV exposure. Investigators will~     stimulate different aspects of the skin's immune system by giving an injection of Candida~     Albicans (CANDIN®) and histamine phosphate (HISTATROL®), topical applications of imiquimod 5%~     cream (ALDARA®) and performing a tape stripping procedure with adhesive tape. The use of~     Candida Albicans (CANDIN®), histamine phosphate (HISTATROL®), and tape stripping are common~     procedures in clinical settings to stimulate skin desired skin responses. Imiquimod 5% cream~     (ALDARA®) is an FDA-approved drug for the treatment of basal cell carcinomas, actinic~     keratoses and genital warts. Investigators will compare the reaction of the skin's immune~     system on a cellular level from skin normally exposed to the sun exposure to an area normally~     hidden from sun exposure.~   "
51781|NCT02889146|"~     The purpose of this study is to verify if a protocol of early and progressive mobility which~     includes the use of technology is able to increase the level of physical activity and improve~     functionality and respiratory and muscular function of Intensive Care Unit patients compared~     with conventional Physical Therapy.~   "
51782|NCT02889133|"~     Primary Hypothesis~        -  The 24-hour post-transfusion RBC recovery of units obtained from donors exhibiting~          iron-deficient erythropoiesis will not meet FDA standards for clinical use.~        -  The 24-hour post-transfusion RBC recovery of units obtained after intravenous iron~          repletion will improve significantly and will meet FDA standards for clinical use.~   "
51783|NCT02889120|"~     Prescription of medicines by telephone in French medical call Centres is a part of the~     general practitioners activity.~      This study aimed to described drug prescription by phone (MTP) performed in four medical call~     centers. The primary objective is to evaluate adherence to french practice guidelines for the~     drug prescription by phone (Haute Autorité de Santé, 2009) The secondary objective is to~     evaluate the risk/benefit ratio for drug prescription by phone.~   "
51784|NCT02889107|"~     This study aimed to evaluate long term benefits in speech reception in noise, after daily 10~     week use of an assisting listening device (personal frequency-modulates systems) , in~     non-aphasic stroke patients with auditory processing deficits.~   "
51785|NCT02889094|"~     The overarching purpose of this study is to further understand the reasons for and clinical~     implications of persistent HBV infection in patients co-infected with HIV and HBV in the era~     of highly effective antiviral treatment against both viruses.~   "
51786|NCT02889081|"~     The study is a prospective birth cohort study and the purpose is to describe the status of~     maternal key nutrients(eg. folate and vitamin D) supplementation among pregnancies at early~     gestation in Shanghai, to find out the association between the level of serum key nutrients~     and atopic dermatitis (AD) in offsprings during 6 months.~   "
51787|NCT02889068|"~     The purpose is to determine the benefit of next generation sequencing (NGS) targeted on genes~     involved in intellectual disability for etiologic diagnosis of intellectual disabilities. In~     other words, it concerns the number of patients whose etiologic diagnosis will be established~     with NGS and could not with common techniques. Actually, the molecular etiology of~     intellectual disability is crucial to calculate the risk of recurrence and allows the~     perinatal diagnosis to these families.~      Secondary purposes are:~        1. To determine the place of NGS in the strategy of etiologic diagnosis of intellectual~          disability, to determine the order of analyses performed for a patient with intellectual~          disability without clinical signs.~        2. To evaluate the number of variants with unknown significance and thus non-usable for~          genetic counselling without supplementary analysis.~        3. To determine the number of samples that can be at most pooled keeping a good efficacy of~          capture and results with suitable read depth~        4. To determine the possibility of detecting copy number variations (CNVs) in genes of~          interest with NGS~        5. To establish genotype/phenotype correlations for each gene for which a mutation has been~          identified~        6. To optimize the software pipelining for a rapid analysis for diagnosis.~   "
51788|NCT02889055|"~     Current recommendations for the conduct of sédationanalgésie ICU encourage the use of the~     lightest possible sedation strategies, avoiding the administration of benzodiazepines source~     of longer durations of ventilation and ICU stay of syndrome cessation, mental confusion.~     Among the proposed alternatives, administration of halogenated volatile agents (sevoflurane)~     in resuscitation is interesting because their favorable pharmacokinetic even after prolonged~     administration: no tachyphylaxis, rapid clearance, no withdrawal syndrome.~      There are two suitable delivery devices sevoflurane in intensive care, both with CE marking.~     The device Mirus ™ (Pall Medical, Fribourg, Switzerland) is the newest and it is easy to use~     and reliable. The objective of this study was to evaluate the use of Mirus ™ device in trauma~     resuscitation and cardiovascular resuscitation.~      Specifically, it will use this modality in case of failure with conventional sedation~     products (propofol, midazolam): maximum permissible doses, sedation weaning failure due to~     severe agitation.~   "
51789|NCT02889042|"~     France is one of the European countries with the highest rate of death by suicide, more than~     10 400 deaths each year, about 16 people out of 100 000. Although suicide mortality rate~     tends to fall between 1987 and 2008 the number of suicide attempts (TS) against observed by~     an upward trend between 2005 and 2010. However, the most important predictor of death by~     suicide remains the TS. Now these are primarily TS Poisoning Drug-Volunteer (IMV), especially~     benzodiazepines. These IMV, there have been 16% recurrence in the past year and 21% at 4~     years among hospitalized patients. Or a Health Barometer 2005 survey showed that 58% of~     respondents with a TS over the last 12 months had not been hospitalized. This type of acting~     out, especially the repeated IMV (IMVr) is underestimated epidemiologically because it is an~     unknown phenomenon and too little screened by health professionals.~   "
51797|NCT02888938|"~     The aims of this study are: 1° to assess the value of pelvic radiography and sacro-iliac~     joint (SIJ) MRI compared to CT scan of SIJ for the diagnosis of structural sacro-iliitis and~     2° to quantify structural elementary lesions on MRI and for the first time on CT-scan~     according to a SPARCC approach in a cohort of patients with a suspicion of spondyloarthritis~     (ECHOSpA).~   "
51790|NCT02889029|"~     Management of complex airway stenoses with dedicated tailored stents wrought by 3D~     computer-assisted conception~      Dedicated Airway Stents for Central Airway Stenoses~      DASCAS~      Toulouse University Hospital is the sponsor of this research.~      This research will be conducted with the support of AnatomikModeling and ADERSPOT~        -  Background: Tracheobronchial stent are devices designed to manage central airway~          stenoses of various origins. Their shape and sizes are however not suitable for stenosis~          of complex anatomy.~        -  Purpose: The investigators propose to test the feasibility and safety of treating~          complex airway stenoses with dedicated tailored stents wrought by 3D computer-assisted~          conception~      Abstract: Central airway obstruction is currently managed with non-personalized stents, which~     are usually efficient but lead to severe and potentially lethal complications in 10% of cases~     (stent migration, obstructive granuloma, perforation, hemoptysis). These stents seem~     particularly unsuited for anatomically complex stenosis.~      Dedicated airway stents (wrought and tailored by 3D computer-assisted conception based on 3D~     chest CT-scan), by fitting perfectly tracheal or bronchial anatomy, should dramatically~     improve the tolerance and safety of such prostheses.~      This first feasibility study, dedicated to patients suffering from anatomically complex~     stenosis will test the safety of treating patients with these new approach. It should lead to~     larger studies evaluating these new types of stents in larger indications.~      After 3D computer-assisted modelization of airways, a virtual prosthesis and its shape are~     designed and the shape of the stent is wrought by 3D-machining by AnatomikModeling®. The~     stent is then build and sterilized by Sebbin® and inserted during rigid bronchoscopy on the~     same terms as pre-existing models.~      Close follow up is then conducted, including clinical evaluation after one week, three and~     six months; spirometry at one week and 6 months and chest CT-scan at one week.~   "
51791|NCT02889016|"~     This study is an investigation of the neurologic, immunologic, and rheumatologic markers of~     Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS). PANS is a condition characterized by~     the abrupt, dramatic onset of obsessive compulsive disorder (OCD) and/or eating restriction~     accompanied by equally abrupt and severe co-morbid neuropsychiatric symptoms, which include~     anxiety, emotional lability, depression, irritability, aggression, oppositionality,~     deterioration in school performance, behavioral (developmental) regression, sensory~     amplification, movement abnormalities, sleep disturbance, and urinary frequency. PANS is~     thought to be caused by infection, inflammation, or alternate triggers that is associated~     with a brain response that leads to these symptoms. The purpose of this study is to examine~     specific neurologic, immunologic, rheumatologic, and genomic, components in children with the~     acute-onset of psychiatric symptoms. This research may begin to uncover a much larger story~     of autoimmune processes that are involved in psychiatric disorders of childhood. By better~     understanding the etiologic components of psychiatric phenomenon, future treatments may be~     better targeted to underlying causes.~   "
51792|NCT02889003|"~     Single-center study, prospective, phase II trial.~      The study objectives are :~        -  To assess safety and pharmacokinetics of the combination of PIO and TKI in CML subjects~          who experience a loss of MMR following a first TKI discontinuation.~        -  To assess survival without loss of MMR over a 12 months period following a second TKI~          discontinuation in subjects who achieve or maintain < MR4.5 with the combination PIO and~          TKI administered for at least 6 months.~   "
51793|NCT02888990|"~     1. The use of imatinib in combination or in association with chemotherapy is now considered~          as the gold standard for the treatment of Ph+ ALL. The complete remission (CR) rate is~          90% versus 20% to 40% with chemotherapy alone. The combination of imatinib, vincristine~          and dexamethasone is a well tolerated regimen in aged patients and is also associated~          with a high CR rate of 80% to 90% in patient aged 55 years and over.~        2. However, despite high CR rates, the progression free survival rate at 12 months of~          patients treated with the combination of imatinib and chemotherapy is 30% to 50%.~          Relapses remain frequent and only patients intensified with allogenic haematopoietic~          stem cell transplantation are in long term remission. This strategy is not fully~          applicable to most patients aged 55 years and over.~        3. Relapses after or during imatinib therapy in patients with Ph+ ALL are associated with~          BCR-ABL tyrosine kinase domain mutation in 80% of cases, predominantly of the p-loop.~          The exact incidence of the T315I mutation is controversial and can be estimated to be~          near 50%. Conversely, the detection of the T315I or F317 mutation in a patient is a very~          strong predictor of relapse.~        4. Dasatinib is a potent SCR and BCR-ABL tyrosine kinase inhibitor with preserved in vitro~          activity in most of the BCR-ABL mutated cell lines, except for the T315I and F317~          mutations. This is also the case in vivo, with patients harbouring BCR-ABL TK domain~          mutations remaining sensitive to dasatinib. The CHR rate in Ph+ ALL resistant to~          imatinib is 33% and the median progression-free survival is 3.7 months. Progression free~          survival (PFS) rate at 12 months is 22%.~      The goal of this trial is to evaluate the efficacy and the tolerance of the combination of~     dasatinib with chemotherapy in the front-line setting as induction and consolidation therapy~     in Ph+ ALL patient aged 55 years and over. A European consensus has been reached to adopt a~     common chemotherapeutic schedule for patients aged 55 years and over. This schedule will be~     used in this trial with the addition of dasatinib as concomitant therapy during induction and~     alternating with chemotherapy during consolidation and maintenance. A CR rate of 90% and a~     progression free survival of 60% at 12 months are expected. The patients will be~     prospectively monitored for minimal residual disease and mutation.~   "
51794|NCT02888977|"~     The use of imatinib in combination with chemotherapy is now considered as the gold standard~     for the treatment of Ph+ ALL. The complete remission (CR) rate is 90% versus 20% to 40% with~     chemotherapy alone. The combination of imatinib, vincristine and dexamethasone is a well~     tolerated regimen in aged patients and is also associated with a high CR rate of 80% to 90%~     in patient aged 55 years and over. 2. Dasatinib is indicated as first line therapy in Ph+~     ALL. Results from the EWALLPH-01 are supporting the use of dasatinib in combination with~     low-intensity chemotherapy. A new EWALL-PH-02 study combining nilotinib in combination with~     low-intensity chemotherapy is currently initiated within the EWALL centers.~      3. The EWALL-PH-01 trial is now closed after the recruitment of 71 patients. The activation~     of the EWALL-PH-02 trial is expected for Q1 2012. Based on the recruitment of the EWALL-PH-01~     study it could be anticipated that 50 to 100 patients aged more than 55 years will be~     diagnosed during this 6 months period of time. In addition, all the EWALL centers are not~     participating to the EWALL-PH-02 study and thus these centers could be offered to treat~     patient following the EWALL backbone in addition to imatinib. 4. A minimum data set will be~     defined in order to collect the data of the patients treated following the EWALL-PH imatinib~     study. The main recommendation is to follow as close as possible the procedures of the~     EWALL-PH-01 trial (mutation analysis, MRD follow-up) in order to have a comparable data set.~     This imatinib treated cohort of patients would be of particular importance in order to better~     define the potential benefit of using one TKI compared to one other. From the end of the~     EWALL-PH-01 study recruitment to the initiation of the EWALL-PH-02 study, patients were~     treated following the common backbone schedule in combination with imatinib or others TKI.~     Patients not included in clinical trials for other reasons were also offered a treatment with~     the combination of TKIs and backbone low-intensity chemotherapy. The goal of this observatory~     retrospective and prospective is to describe the efficacy and the tolerance of the~     combination of tyrosine kinase inhibitors in combination with low intensity chemotherapy~     (EWALL backbone) in patients with Ph+ ALL aged 55 years and over.~   "
51795|NCT02888964|"~     This project is a Phase II clinical trial that aims at evaluating efficacy and tolerance of~     the combination of pioglitazone (Actos®) and imatinib mesylate (STI571, CGP57148, Gleevec®)~     in patients with Chronic Myelogenous Leukemia (CML) in stable major molecular response (i.e.~     a BCRABL/ABL ratio assessed by RTQ-PCR equal to or lower than 0.1% according to the European~     Leukemia Net recommendations) after at least 2 years of therapy with imatinib.~      Imatinib mesylate (Gleevec®) is the gold standard for the treatment of CML in chronic phase~     (O Brian et al. 2003, Druker et al. 2006). Despite a high efficacy of the drug, CML is not~     eradicated by imatinib alone in almost any of the patients.~      Treatment discontinuation in patients treated by imatinib and in complete molecular remission~     for more than 2 years yield molecular relapses within 6 months in half of the~     patients,indicating the persistence of CML progenitor cells. STAT5 expression is required for~     CML stem cell engraftment and expansion in mouse models. STAT5 is the target of the~     dysregulated activity of BCR-ABL in CML.~      Recently, Stephane Prost et al. demonstrated that PPAR-γ is a negative regulator of STAT5A~     and STAT5B gene expression. Data obtained suggest that PPAR-γ agonists may have potential~     therapeutic value in reversing myeloproliferative disorders. On the basis of our preclinical~     studies, we went ahead and administered pioglitazone to one patient who suffered from both~     diabetes type II and CML with residual disease after continuous treatment with Gleevec. The~     amount of BCR-ABL transcript detected by QPCR decreased dramatically during the first 3~     months of combined (Gleevec + ACTOS) therapy to become undetectable thereafter until 9 months~     post-treatment, the latest time point assessed. This striking anecdotal result now forms the~     rationale for filing this formal Phase II clinical trial application.~   "
51796|NCT02888951|"~     This study evaluates the amount of fluid remaining in the stomach of diabetic patients after~     a standard fasting period, and compare it with non-diabetic patients coming for elective~     surgical procedures.~   "
51798|NCT02888925|"~     The purpose is to evaluate neuropsychological effects of anterior temporal epilepsy in face~     perception by comparison of performances of epileptic patients and control individuals, sex-,~     age- and socio-educational level-matched.~      Secondary purposes are to prospectively evaluate neuropsychological impact of anterior~     temporal lobectomy performed for surgical treatment of anterior temporal epilepsy on face~     perception (exploratory study).~   "
51799|NCT02888912|"~     The aim of this clinical trial was to compare the clinical performances of a glass ionomer~     restorative system with a micro hybrid resin based composite in class I and class II~     cavities. A total of 140 (80 class I and 60 class II) lesions in 59 patients were restored~     with a glass ionomer restorative system (Equia) or a micro hybrid composite(Gradia Direct).~     Restorations were evaluated at baseline and yearly during 6 years according to the~     modified-USPHS criteria. Data were analyzed with Cohcran's Q and McNemar's tests (p<0.05).~   "
51800|NCT02888899|"~     Background: Fecal incontinence (FI) affects 2-13% of an adult general population. The~     prevalence increases with age, and after 50 years of age prevalence rates up to 26% in women~     have been reported. Quality of life in patients with FI is decreased considerably, in a~     similar extent as in patients with ulcerative colitis in relapse.~      Management of FI usually involves a stepwise approach; beginning with more conservative~     strategies and moving on to more appropriately tailored medications, bowel-retraining,~     biofeedback and psychosocial support. Although a combination of these treatment alternatives~     often improves symptoms they are not always successfully. Neuromodulation is a relatively new~     treatment modality for FI that is based on recruitment of residual anorectal neuromuscular~     function pertinent to continence by electrical stimulation of the peripheral nerve supply.~     Sacral Nerve Stimulation (SNS) is one type of neuromodulation and it employs direct~     electrical stimulation of the sacral nerves. Recently an alternative neuromodulation~     technique to SNS has been developed in treating FI i.e. tibial nerve stimulation. The tibial~     nerve contains afferent and efferent fibers originating from the forth and the fifth lumbar~     nerves and the first, second and third sacral nerves. Thus, stimulation of the tibial nerve~     may lead to changes in anorectal neuromuscular function similar to those observed with SNS~     but without the need of a permanent surgically implanted device. Tibial nerve stimulation is~     therefore an attractive treatment alternative for FI patients since the treatment is~     well-tolerated and treatment results have been very promising.~      Aim: The overall aim is to measure the effect of percutaneous tibial nerve stimulation (PTNS)~     in combination with biofeedback on symptoms in consecutive FI patients compared with~     biofeedback alone. The investigators also aim to study which FI patients have most profit of~     the addition of PTNS.~      Methods: The study will take place at the Pelvic Floor Unit, department of Gastroenterology,~     University Hospital Linköping. Prior to the first visit to the hospital a symptom diary will~     be mailed to the FI patients and they are instructed to record their FI symptoms, bowel~     habits and gastrointestinal symptoms prospectively on a 24-hour diary during 2 weeks. Before~     consideration of enrolment into the study, gastroenterologists assess all the patients'~     medical history and perform a physical examination. Subjects will also have an endoanal~     ultrasonography and the investigators will measure rectal volumes, sensational thresholds and~     anal sphincter function.~      FI patients who fulfil inclusion criteria will then be randomly assigned to either PTNS in~     combination with biofeedback or biofeedback alone. The treatment will be performed by~     physiotherapists.~   "
51801|NCT02888886|"~     The purpose is to study the correlation between systemic inflammation (serum levels of CRP,~     IL-1beta, IL-6 and TNF-alpha) or hyperhomocysteinemia and the increase of mortality, in a~     representative cohort of patients with chronic obstructive pulmonary disease (COPD).~      Secondary purposes are:~        1. To confirm the increase of cardiovascular mortality and the importance of cardiovascular~          morbidity in patients with COPD,~        2. To establish the role of various genetic polymorphisms in the correlation between~          systemic inflammation and cardiovascular disorders observed in COPD,~        3. To search for acceleration of aging of cardiovascular system evaluated with carotid~          intima-media thickness when systemic inflammation markers are increased,~        4. To study the correlation between COPD risk factors (tobacco and other food factors),~          change of respiratory functional data and cardiovascular morbi-mortality. In this study~          cardiovascular morbi-mortality is defined by following disorders: ischemic cardiopathy,~          left-sided heart failure, cardiac arrhythmia and cerebrovascular accident. Diagnosis is~          confirmed with standard techniques and independently of this study. Results of clinical~          examination, ECG, echocardiography and /or brain scanner will be collected.~   "
51802|NCT02888873|"~     The aim of this randomized, prospective clinical study was to compare the clinical~     performance of a universal light-curing, ultra-fine particle hybrid composite with a new~     version of this product produced by the same manufacturer in Class 1 and Class 2 lesions.~   "
51803|NCT02888860|"~     It is proposed to carry out the study in three medical or surgical intensive care units (ICU)~     in the CHRU, Lille, and the CHU, Besançon. In all patients admitted to these ICU (see Figure~     2), a corrected index of colonisation (CIC) will be determined and blood samples will be~     taken for genotyping of the lectins MBL, Dectin-1 and Galectin-3 and for serology. Over the~     duration of hospitalisation (on average 28 days) and weekly, fungal colonisation will be~     assessed in all patients (according to the CIC), and antibodies to yeast glycans will be~     determined by a simultaneous multiparametric analysis involving several families of natural~     or synthetic antigens, and the detection of circulating antigens (mannan and β-1,3 glucan).~   "
51804|NCT02888847|"~     Compare teeth sensitivity using bleaching protocol with different light intensities (Philips~     Zoom!™ White Speed whitening gel and lamp, Discus Dental, Inc., Culver City, CA, USA.) versus~     bleaching protocol with the same light intensity (Philips Zoom!™ Advanced Power whitening gel~     and lamp, Discus Dental, Inc., Culver City, CA, USA.).~   "
51805|NCT02888834|"~     Introduction: Elderly aged over 65 years accounted for around 17.5% of the French general~     population. Adverse drug reactions (ADR) are common in this population. In elderly subject,~     prevalence of ADRs ranged from 4.3% to 63.0%.~      Aim: To describe the serious ADR in elderly subjects aged over 65 years and assess their~     preventability.~      Methods: A retrospective study was conducted at the Regional Pharmacovigilance Center of~     Champagne-Ardenne (northeast of France) between January and May 2013. Patients aged over 65~     years who presented a serious ADR notified to the Regional Pharmacovigilance Center were~     included in the study.~   "
51806|NCT02888821|"~     A school-based behavioral intervention for Mexican youth with attention/behavior concerns~     (the Collaborative Life Skills Program for Latinos/Familias Unidades Empezando Retos y Tareas~     para el Éxito [CLS-FUERTE]:) will be pilot-tested in a mixed-method investigation with four~     Mexican elementary schools.~   "
51807|NCT02888808|"~     Obesity is a strong risk factor for GERD. This study assessed the role of obesity among~     patients having erosive GERD and controls.~   "
51817|NCT02888678|"~     This study evaluates whether the integration of an Economic Strengthening program with an~     HIV-prevention education program produce synergistic effects on economic and health outcomes~     for South African youth ages 14-17 years old.~   "
52063|NCT02885441|"~     Patients with acute pancreatitis will be randomly assigned in either study group to receive~     oral Ketorolac or control group (double blind study).~   "
51808|NCT02888795|"~     Hypertonic dextrose prolotherapy has been used in knee osteoarthritis (OA) clinically for a~     long time. However the study about the mechanism is scant. The question of biomarkers of knee~     OA cartilage response to hypertonic dextrose prolotherapy remains currently unresolved. On~     this basis, the aim of this study was to characterize the secreted protein factors behind the~     inflammatory potential involving the hypertonic dextrose prolotherapy of knee OA.~      10~12 older than 65 years old knee OA patients will be recruited for clinical Western Ontario~     McMaster University Osteoarthritis (WOMAC) index, knee X ray evaluation and knee joint~     synovial fluid analysis before and after hypertonic dextrose prolotherapy. The expressions of~     inflammatory factors will be measured by a novel cytokine antibody array methodology. The~     study will evaluate inflammation-related cytokines in patients of knee joint synovial fluid.~     Human Cytokine Antibody Array that allows profiling synovial fluid production of anti and~     pro-inflammatory cytokines simultaneously. Altered levels of cytokine from the array~     membranes incubated with tissue lysates will quantitatively depict as a histogram for~     relative cytokine induction or reduction in the synovial fluid. The cytokines messenger~     ribonucleic acid levels will be quantified by quantitative reverse-transcription polymerase~     chain reaction and proteins expression was analyzed by Enzyme-Linked ImmunoSorbent Assay. The~     WOMAC Index, minimum joint space width, and Human Cytokine Antibody Array between before and~     after interventions will be compared. Differences between groups will be determined by the~     Mann-Whitney U test. For the synovial angiogenesis is accompanied with inflammatory feature~     in knee OA, associations between endothelial growth factor (VEGF) expression and VEGF~     isoforms pattern will be determined with the Spearman correlation.~   "
51809|NCT02888782|"~     Patients who are discharged from hospital can be overwhelmed when they suddenly have to~     manage new conditions or medications. These changes can be particularly difficult for people~     on many medications or with multiple health conditions. There is a real risk that this will~     lead to emergency room visits, hospital readmission, and even death. In addition to~     endangering patients, these adverse events are very costly to the healthcare system. The good~     news is that these events can be preventable if patients receive care that is better~     coordinated.~      Patient-oriented research will be conducted to determine if a pharmacist-led medication~     therapy management service can improve health outcomes of 'medically complex' patients~     transitioning from acute to primary care in Newfoundland and Labrador (NL). This a more~     comprehensive service than their community pharmacist would normally provide. The program~     will use a new Pharmacist Clinic service to provide care and support which does not currently~     exist for patients in NL after they leave hospital. After discharge, patients will be~     randomly divided into two groups: one group will receive care as usual from their doctor; the~     other group will have their medications assessed by a clinic pharmacist within one week of~     hospital discharge along with their usual care from their doctor. The two groups will be~     compared to determine whether specialized pharmacist services after hospital discharge is~     satisfactory to patients/providers, improves patient health, and reduces emergency room~     visits, hospital readmissions, and repeat trips to the doctor. If successful, this project~     will help ensure that patients are taking the right medications in the right way, improving~     individual health and making better use of healthcare system resources.~   "
51810|NCT02888769|"~     The study is a two-arm, parallel, randomized clinical trial. The purpose of the study is to~     evaluate the effectiveness of automated mobile phone text message-based intervention for~     secondary prevention, including lifestyles modification, medication adherence improvement and~     risk factors control among coronary heart disease (CHD) patients without diabetes. The~     participants will be randomized into intervention and control groups in a 1:1 ratio. The~     intervention group will receive 6 pre-designed text messages per week in addition to usual~     care for 6 months, while the control group will receive usual care.~   "
51811|NCT02888756|"~     iHIVARNA-01 is a novel therapeutic vaccine for the treatment of HIV-1-infected patients based~     on in vivo modification of DCs. It consists of HIVACAT-TriMix: mRNA encoding a mixture of APC~     activation molecules (CD40L, a constitutively active variant of TLR4 and CD70) and the HIV~     target antigens contained in HIVACAT to be administered through the intranodal route.~     iHIVARNA-01 aims to achieve the 'functional cure' of HIV infection, i.e. controlling viral~     replication in the absence of anti-retroviral therapy.~   "
51812|NCT02888743|"~     This randomized phase II trial studies the side effects of durvalumab and tremelimumab and to~     see how well they work with or without high or low-dose radiation therapy in treating~     patients with colorectal or non-small cell lung cancer that has spread to other parts of the~     body. Monoclonal antibodies, such as durvalumab and tremelimumab, may interfere with the~     ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill~     tumor cells and shrink tumors. Giving durvalumab and tremelimumab with radiation therapy may~     work better in treating patients with colorectal or non-small cell lung cancer.~   "
51813|NCT02888730|"~     Patients with cystic fibrosis frequently develop chronic rhinosinusitis. Bacterial~     colonization is facilitated by a reduced mucociliary function and some previous studies~     suggest that the microbiology of the upper airways might influence the microbiology of the~     lower airway. The aim of this randomized control study is to demonstrate efficacy of~     antibiotic delivered by nebulized sonic aerosol therapy to decrease the bacterial load in~     sinuses and medium ostia and to improve the sino-nasal symptoms and endoscopic scores,~     quality of life and lung function~   "
51814|NCT02888717|"~     The para-aortic lymph node involvement in the advanced stage of cervical cancer is a poor~     prognostic factor for overall survival. Concomitant chemo-radiotherapy has become the~     standard treatment for advanced cervical cancer. In case of para-aortic lymph node~     involvement, an extension of radiotherapy fields is recommended.~      A prospective multicentre study shown that the survival rate of patients with node ≤ 5 mm and~     which benefited from the expansion of radiotherapy fields was identical to the survival of~     pN0 patients.~      However, due to a specific disease, this technique should not be performed in all patients.~     It is necessary to reliably select patients with retroperitoneal lymph node involvement. For~     this, it is recommended that prior to the concurrent chemo-radiotherapy, nodal staging~     surgery with a definitive histological analysis.~      So we propose to use molecular diagnostic test OSNA (One Step Nucleic Acid Amplification) to~     improve lymph node metastasis detection sensitivity to achieve ultra-staging compared to~     conventional histology.~   "
51815|NCT02888704|"~     This study aims to evaluate safety, tolerance, and efficacy in subjects with over moderately~     subacute and chronic atopic dermatitis after an intravenous injection of autologous~     mesenchymal stem cells. The study is composed of two steps. Step 1 is to determine clinically~     proper dose capacity of the ADSTEM Inj. and step 2 is to evaluate exploratory efficacy of the~     ADSTEM Inj. at the proper dose.~   "
51816|NCT02888691|"~     The aim of the study is to investigate glycemic control during a low carbohydrate diet~     compared with during a high carbohydrate diet in adults with insulin pump treated type 1~     diabetes.~   "
51818|NCT02888665|"~     This phase I/II trial studies the side effects and best dose of doxorubicin hydrochloride~     when given together with pembrolizumab and to see how well they work in treating patients~     with sarcoma that have spread to other parts of the body or that cannot be removed by~     surgery. Drugs used in chemotherapy, such as doxorubicin hydrochloride, work in different~     ways to stop the growth of tumor cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Monoclonal antibodies, such as pembrolizumab,~     may interfere with the ability of tumor cells to grow and spread. Giving doxorubicin~     hydrochloride together with pembrolizumab may work better in treating patients with sarcoma.~   "
51819|NCT02888652|"~     Study on the registration of coronary heart disease patients undergoing PCI in Chinese's~     population. Get the incidence of adverse events in these patients after PCI, a clear type of~     adverse reaction, forms, influencing factors, to establish risk management processes,~     clinical safety and reasonable treatment, and provide the basis for further research and~     reference.~   "
51820|NCT02888639|"~     The pharmacoepidemiological EPHEYL (Étude PHarmacoÉpidémiologique de l'hYperparathyroïdie~     secondaire en Lorraine) study is a 2-year, open-cohort, prospective, observational study on~     incident SHPT, i.e. newly diagnosed, with a 2 year follow-up, set in the 12 dialysis units~     located in the French region of Lorraine (public or private).~   "
51821|NCT02888613|"~     This study aims to compare the results of two mini invasive surgical approaches in abdominal~     aortic surgery: mini lumbotomy with retroperitoneal approach versus mini laparotomy with~     transperitoneal approach. Respiratory and renal functions and recovery of intestinal transit~     will be assessed after 30 days.~      The secondary purpose of this study is to assess the life quality and morbi-mortality at 30~     days, as well as at 6 and 12 months.~   "
51822|NCT02888600|"~     This study is a two-arm randomized controlled trial comparing two 8-week stress management~     programs for reducing inflammation and improving well-being among older adults.~   "
51823|NCT02888587|"~     The study has two objectives:~        1. To obtain endoscopic and colonoscopic biopsies to harvest and culture intestinal crypts~          from human tissue to produce organoids. These organoids will be used to study the~          biology of innervated sensory epithelial cells.~        2. to collect subject data relating to clinical management and demographic characteristics~          of patients undergoing upper endoscopy or colonoscopy to learn the mechanisms behind~          visceral hypersensitivity, and neurodegenerative diseases that may arise in the gut.~   "
51824|NCT02888574|"~     This study is a placebo-controlled, double-blind, within-participants crossover investigation~     of the effect of intranasal oxytocin on pain and function among women with chronic pelvic~     pain.~   "
51825|NCT02888561|"~     Patients with poor heart function can, in certain situations, have a further weakening of the~     heart muscle such that it becomes difficult to provide enough blood to the brain and other~     organs. In these cases, heart function can be supported by the use of medicines or heart~     pumps. One of the most widely used medicines is Dobutamine, given as an infusion (a drip).~     Although Dobutamine has been in use for decades and does improve blood flow to the organs,~     previous studies have not shown any impact on recovery of heart muscle function and survival.~     Key to unravelling this discrepancy is to understand the precise effects of Dobutamine on the~     oxygen supply to, and oxygen usage by, the heart muscle. We also aim to find out whether~     simultaneous infusion of another drug called Nitrite (naturally occurring substance that is~     found in beetroot for example, much like GTN) can enhance the beneficial effects of~     Dobutamine on the oxygen supply-demand balance of the heart. In recent years, major advances~     in technology mean that it is now possible to obtain this information in patients undergoing~     coronary angiography procedures by making detailed measurements of heart muscle function and~     blood flow in the heart arteries using a conductance catheter (measures volume and pressure~     within the main pumping chamber of the heart) and the Combowire (dual pressure and flow~     sensor tip angioplasty guidewire). The aim of this study is to understand the effect of a~     brief infusion of Dobutamine and nitrite on heart muscle function, oxygen supply and oxygen~     usage through this use of this technology, directly following the patients routine coronary~     angiogram. Patients will have these measurements taken using the technology described above~     during the infusion of both dobutamine and nitrite, inserted through blood vessels that reach~     the heart.~   "
51826|NCT02888548|"~     Upper limb spasticity is currently mainly managed with local toxin treatments. Recent studies~     suggested combining botulinum toxin injections with splinting to optimise rehabilitation in~     spastic patients. However, one study focused exclusively on lower limb spasticity, the second~     on elbow flexor hypertonia, and the last on wrist and finger spasticity in children.~      A study was performed in adult patients with upper limb spasticity treated with botulinum~     toxin injections used as primary objective the tolerance for dynamic splinting. The authors~     noted that the need for botulinum toxin was reduced in 2 patients out of 6. No study has been~     conducted to date on the splinting + toxin combination in adults.~      Another study showed that stretching sessions over 2 weeks of a muscle just given botulinum~     toxin helped improve the toxin's efficacy 2, 6 and 12 weeks after the injection. For this~     reason, rehabilitation teams routinely prescribe 10 sessions of physiotherapy for 15 days~     after botulinum treatment.~      Based on this principle, we hypothesise that dynamic night splinting applied just after~     botulinum toxin treatment may also increase the toxin's efficacy. We chose a dynamic splint~     providing continuous stretching of the wrist and fingers in extension whilst allowing active~     flexion. Night splinting is thought to promote optimal functional use of the paretic upper~     limb during the day and thus prevent learned non-use, which could worsen the spasticity.~      Each patient will receive treatment cycles, whose results will be compared, so that each~     patient will act as his/her own control. The evaluation will be based on the Tardieu scale~     chosen for its greater inter-individual reproducibility and greater reliability to measure~     spasticity.~      The degree of extension of wrist and fingers provided by the splint will be adjusted to the~     patient's clinical condition with the elastic tensioners. The purpose of the splint is to~     maintain the stretch beyond the Tardieu spasticity angle at fast speed (V3) without reaching~     maximum extension, which could be harmful.~      This protocol is designed to determine whether dynamic night hand splinting combined with~     botulinum toxin injections will improve botulinum antispastic efficacy in adults with brain~     damage.~   "
51827|NCT02888535|"~     Primary immune deficiencies (PID) are characterized by a failure of the immune system that is~     not explained by any infectious, neoplastic, or iatrogenic cause. In 2015, more than 300~     different inherited rare disorders were described. The occurrence of PID in adult is rare and~     diagnosis may be supported by the 6 ESID signs for adult. However these warnings signs are~     based only on expert recommendations and do not include comprehensive symptoms of PIDs.~     Recurrent infections, more aggressive, are the most common mode of revelation of the PID.~     Less frequently, autoimmune manifestation, solid tumor, lymphoproliferation tumor, chronic~     granulomatosis or hemophagocytic lymphohistiocytosis syndrome (HLS) may also revealed a PID.~     The objective of this study was to evaluate the occurrence of unknown PID in adult admitted~     in critical care unit and to determinate if the investigation of PID in patients with severe~     infections or HLS should be routinely performed in MCIU.~   "
51828|NCT02888522|"~     Allogeneic hematopoietic stem cell transplantation (Allo-HSCT) is now an effective treatment~     of Acute Myeloid Leukemia (AML). After allo-HSCT, relapses are the major cause of mortality~     and occur in about 30% of cases. The occurrence of relapses is important during the first~     three months post-allogeneic transplant, then gradually decreases during the first year~     post-allograft and then becomes weaker. After relapse, therapeutic options include the~     reduction of immunosuppression, the administration of donor lymphocytes (DLI), chemotherapy~     or a new transplant. The performance is influenced by the early introduction of treatment~     whose effectiveness is related to the importance of tumor burden. Immunomodulation of~     preemptive strategies have recently been established by decreasing immunosuppression and~     achieve DLIs in patients with a high risk of relapse, before the occurrence of relapse.~      The aim of this study is to evaluate the incidence of relapse following the recommendations~     of post-allogeneic transplant immunomodulation of the French society of bone marrow~     transplantation.~   "
51829|NCT02888509|"~     To explore the neural and cognitive mechanisms of depression (including unipolar depression~     and Bipolar disorder) and anxiety using multimodal MRI techniques.~   "
51830|NCT02888496|"~     Pathophysiology of polymyalgia rheumatica (PMR) is ill defined. This study aims at~     characterizing immunological abnormalities in PMR patients, and to assess the effects of~     tocilizumab therapy on this abnormalities.~   "
51831|NCT02888483|"~     The overall objective of this project is to evaluate and validate the accuracy and usability~     of a deployed beta sensor-based system. This is a cross-sectional validation study of 100~     apparently health community dwelling adults aged 60+ years. Participants will perform~     standardized lifestyle, exercise and sedentary type physical activities in a clinic~     laboratory and home setting.~   "
51832|NCT02888470|"~     The aim of the study is to estimate the proportion of intensive care unit patients receiving~     current aminoglycosides dosing regimens as part of their antibiotic therapy and achieving the~     recommended maximal plasma concentration (Cmax) after the first and subsequent aminoglycoside~     doses.~   "
51833|NCT02888457|"~     Rationale~      In Belgium, a unique situation exists for two reasons: on the one hand, the pneumococcal~     conjugate vaccine (PCV) program, which started in 2007, has quickly reached high coverage in~     infants: 3-dose coverage rose from 89 % in 2008 to 96.5 % in 2012 in Flanders and from 80.7 %~     in 2009 to 89.2 % in 2012 in Wallonia; and on the other hand, serotype coverage has moved~     from PCV7 (since 2007) to PCV13 (since 2011) and very recently to PCV10 (since July 2015 in~     Flanders and expected in May 2016 in the French Community). Invasive pneumococcal disease~     (IPD) surveillance has demonstrated a major impact on PCV13 serotypes in infants < 2 years of~     age. The impact of the current change in PCV-program is hard to predict, but could eventually~     result in a re-emergence of serotypes not covered by PCV10 (i.e. 3, 6A and 19A).~      With this unique situation the foundation was laid for a carriage study during which the~     nasopharyngeal carriage of Streptococcus pneumonia (Sp) and other common colonizers of the~     nasopharynx will be studied in infants with acute otitis media (AOM) and in healthy infants~     attending day-care centers (DCC), two populations with high reported pneumococcal carriage.~     Young children are an important reservoir and major source of transmission of bacteria to the~     whole community and thus the preferred population to study nasopharyngeal (NP) carriage.~      Aim of the study~      The main aim of this study is to evaluate if changes in the conjugate anti-pneumococcal~     vaccination program in Belgium have an impact on the nasopharyngeal carriage of Pneumococcus~     in infants aged 6-30 months suffering from AOM or attending day-care, in order to guide~     future pneumococcal vaccine program decisions and vaccine development, and to feed AOM~     treatment guidelines in a PCV-program environment. The study will monitor overall~     pneumococcal carriage, the serotypes involved and the sensitivity of the isolated strains to~     antibiotics. In addition, the rhinopharyngeal carriage of other common nasopharyngeal~     colonizers associated with disease, in particular Haemophilus influenzae, will be studied in~     order to evaluate if changes in pneumococcal carriage impact on the carriage of those~     pathogens. In infants with AOM, the study will also monitor the clinical course of the AOM~     and a second nasopharyngeal sample will be taken in case of antibiotic treatment failure or~     AOM recurrence to identify any association with the carried pathogen.~   "
51834|NCT02888444|"~     A placebo-controlled trial to determine whether recent ex-smokers with COPD who successfully~     stop smoking after taking varenicline are less likely to relapse back to smoking if they~     continue using varenicline for a further 12 weeks~   "
51835|NCT02888431|"~     The purpose of this study is to determine the correlation between pH, base deficit, and~     lactate values when comparing venous and arterial blood samples in the pediatric population.~   "
51836|NCT02888418|"~     This study evaluates the safety of Tetravalent recombinant human papilloma virus vaccine~     (6,11,16,18 type) (Hansenula polymorpha) in women of 9 to 30 years old and men of 9 to 17~     years old and preliminarily explore the immunogenicity.~      135 people are enrolled in total, including 45 women of 18 to 30 years old and 90 people of 9~     to 17 years old. Among the first group, 30 women will be inoculated studied vaccine and 15~     women will be inoculated placebo. Among the second group, there are 45 women and 45 men, 30~     women and 30 men in vaccine group and 15 women and 15 men in placebo group.~   "
51837|NCT02888405|"~     The present study sought to investigate the effects of acute dietary changes on estimates of~     body composition. Specifically, the impact of an acute high-carbohydrate diet (9 g/kg body~     weight of carbohydrate) and an acute very low-carbohydrate diet (1 - 1.5 g/kg body weight of~     carbohydrate) were examined.~   "
51838|NCT02888392|"~     The proposed study will primarily demonstrate the efficacy of kiwifruit as a food~     intervention for the relief of constipation and associated symptoms in functionally~     constipated adults, and those with IBS-C. Secondary measures will show the consumption of~     kiwifruit will result in improvements in gastro-intestinal discomfort levels of adults with~     IBS-C.~   "
51839|NCT02888379|"~     A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the~     Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in~     Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity~   "
51840|NCT02888366|"~     This is a multicenter, blinded prospective study of 2,000 women undergoing mammography for~     breast -related symptoms or signs. Breath tests will be performed in order to demonstrate~     that the outcome of mammography results combined with breast test results improves clinical~     sensitivity and specificity in a group that has an increased prior probability of cancer.~     Breath will be collected and analyzed with a rapid point-of-care instrument (BreathLink™) and~     also with a laboratory-based assay of samples collected into an inflatable bag (BreathBag™).~   "
51856|NCT02888158|"~     The primary objective of this study is to compare two groups of gynecologic/urologic/visceral~     internes in terms of the time required to perform a laparoscopic surgical intervention~     (nephrectomy) on an animal model (pig).~      The two groups of internes differ by the type of training they received: (1) Pelvic-Trainer~     training with robotic assistance versus (2) Pelvic-Trainer training without robotic~     assistance.~   "
52077|NCT02885259|"~     Subcutaneous immunoglobulin (SCIG) and recombinant human hyaluronidase (rHuPH20) will be~     tested in patient witch MMN and currently under maintenance treatment with IVIG for safety,~     tolerability and efficacy.~   "
51841|NCT02888353|"~     Ferromagnetic Implants such as permanent pacemakers (PPM's) and Implantable Cardioverter~     Defibrillators (ICD's) have traditionally been accepted as contraindications to Magnetic~     Resonance Imaging (MRI) due to safety concerns. Over the past several years, MRI safety has~     been established in patients with pacemakers or ICD's but only in patients in whom strict~     vetting procedures were implemented. These vetting procedures were initially developed to~     eliminate devices, leads and device/lead circumstances thought to carry increased risk. Over~     recent years however, objective scientific evidence has failed to support this concern~     raising the question as to whether or not these vetting procedures are necessary.~      Investigators hypothesize that in view of the existing objective scientific data, evolution~     of device technology and the fact that the investigators have scanned more than 2,000 devices~     safely (RPN03-08-11-12 and 00051707) ICD's and pacemakers and device circumstances previously~     excluded from MRI protocols can be safely scanned without prior vetting.~      This is a prospective, non randomized, cohort study. Seventeen Hundred participants with an~     implanted ICD or pacemaker and a clinical need for MRI will be included in the study. Unlike~     previous studies where strict vetting procedures were implemented pre-procedure, All patients~     with a pacemaker or ICD and clinical need for an MRI will be eligible for inclusion in the~     study provided participants meet standard MRI inclusion/exclusion safety criteria.~   "
51842|NCT02888340|"~     The investigators will study acupuncture in a pilot, randomized controlled trial (RCT) in the~     emergency department (ED) of a large, tertiary care hospital, Abbott Northwestern Hospital~     (ANW). The investigators suggest that the proposed intervention - provision of acupuncture in~     the ED as an alternative to usual ED care - will reduce pain and interrupt the trajectory~     (and potential cycle) of medication misuse by providing an alternative at a critical point of~     contact within the healthcare system, potentially disrupting the pathway from ED visit to~     opioid usage after discharge.~   "
51843|NCT02888327|"~     This open-label, four group, fixed-sequence study will evaluate the safety and~     pharmacokinetic interaction of AL-794 on oseltamivir, JNJ-63623872 (formerly VX-787) and~     probes for P-glycoprotein, CYP3A and OATP1B1 in healthy volunteers.~   "
51844|NCT02888314|"~     The goal of this study to evaluate the association between Pokemon Go and physical activity~     through a survey among Pokemon Go players.~   "
51845|NCT02888301|"~     This clinical trial studies 18F-clofarabine positron emission tomography (PET)/computed~     tomography (CT) in imaging patients with cancer before and after treatment with a therapy~     that activates the patient's immune system (immunotherapy). PET/CT scans give detailed~     pictures of areas inside the body. 18F-clofarabine is a drug that contains a radioactive~     substance that is taken up by cells expressing deoxycytidine kinase (dCK), which is highly~     expressed in activated immune cells, making them light up during PET/CT scans. Doctors also~     want to know how 18F-clofarabine is distributed throughout the body before and after~     treatment with immunotherapies.~   "
51846|NCT02888288|"~     The purpose of this study is to evaluate if a group-based mental health intervention called~     Sauti ya Vijana (The Voice of Youth) designed to address mental health challenges faced by~     adolescents in Tanzania is acceptable and feasible and if it improves mental health,~     antiretroviral therapy (ART) adherence, and virologic outcomes among HIV-positive adolescents~     as compared to youth receiving treatment as usual. Mental health intervention sessions will~     take place three times a month for approximately four months in groups of eight to ten youth~     based on age and sex. Caregivers will attend two sessions to support the youth and provide~     the guardian perspective on caring for HIV-positive adolescents. The investigator~     hypothesizes the mental health intervention will be acceptable, feasible, and will improve~     mental health and ART adherence among participating youth and this improvement will be~     sustained over time.~   "
51847|NCT02888275|"~     Dexmedetomidine is a selective α-2 receptor agonist with a sedative and cardiopulmonary~     profile that makes it an attractive anesthetic for pediatric patients with congenital heart~     disease (CHD). The aim of this study was to investigate the renal protective effect of~     dexmedetomidine in the perioperative setting in children with heart disease.~      Total 144 pediatric patients allocated dexmedetomidine (DEX) and did not receive the drug~     (NoDEX) group.~      The primary objective of this study was to assess the relationship between the use of~     intraoperative dexmedetomidine and the incidence of acute kidney injury in pediatric patients~     undergoing cardiopulmonary bypass. The secondary objective was to determine whether there was~     an association between dexmedetomidine use and duration of mechanical ventilation or~     cardiovascular ICU stay.~   "
51848|NCT02888262|"~     This longitudinal study aims to identify 1) a composite blood-based biomarker, 2) a composite~     electronic Smartphone-based biomarker and 3) a neurocognitive signature for bipolar disorder~   "
51849|NCT02888249|"~     The purpose of this study is to determine whether the abuse liability of cigarettes with~     altered composition (cigarettes differing in composition; e.g., tar levels, amount of sugar,~     casings) is reduced relative to standard composition cigarettes.~   "
51850|NCT02888236|"~     A study of LEO 32731 in the treatment of psoriasis vulgaris~   "
51851|NCT02888223|"~     Participants will be assigned to A or B groups with a scale of 1:1 based on a prospectively~     randomized treatment-sequence assignment, i.e. infuse SCT800 followed by Xyntha (group A), or~     the alternate sequence (group B). All participants who completed the SCT800HA1 study will~     enter the efficacy and safety study (Protocol No.: SCT800HA3).~   "
51852|NCT02888210|"~     To evaluate safety and efficacy of MD-15 intraocular lens implanted into the aphakic eyes~   "
51853|NCT02888197|"~     Non-interventional extension study to investigate VVC recurrence and candida colonization~     following the P2 acute VVC study~   "
51854|NCT02888184|"~     The aim of the study is to identify prognostication predictors of 6-months neurological~     outcome in survivors at day 3 after cardiac arrest (CA) treated with therapeutic hypothermia~     (TH).~   "
51855|NCT02888171|"~     The main objective of the study is to compare the impact of oral ferric citrate compared to~     standard of care oral ferrous sulfate on serum iron, percent transferrin saturation,~     ferritin, hepcidin and hemoglobin levels in individuals with moderate to severe chronic~     kidney disease (CKD) and absolute iron deficiency.~   "
52078|NCT02885246|"~     The purpose of this study is to assess the prevalence, strain circulation and disease burden~     of seasonal Influenza A and B in Panama, selected countries of Central America and the~     Caribbean from the Year 2010 to 2015.~   "
51857|NCT02888145|"~     Cryopreservation of ovarian tissue is offered to young girls and women aged under 35 who have~     to undergo sterilizing gonadotoxic treatment, with the aim of preserving their fertility. The~     main part of the ovary is preserved, as primordial and primary follicles are resistant to~     freezing / thawing protocols. In the absence of other techniques (in vivo maturation,~     injecting isolated ovarian follicles, etc.) autografting this cryopreserved tissue is~     currently the only technique allowing fertility to be restored. Autograft is possible only if~     the indication for ovary cryopreservation is a non-neoplastic pathology or a malignant~     pathology with a low risk of ovarian metastasis. In other cases of neoplastic pathologies,~     particularly in cases of acute leukemia, tissue cannot as yet be re-used due to the lack of~     any codified technique for evaluating residual disease (MRD). The team has for two years been~     developing and validating a technique to look for residual disease in fragments of ovarian~     cortex in cases of acute leukemia. This technique is based on an original protocol for~     dissociating ovarian tissue to obtain a population of isolated ovarian cells that may be~     analyzed by multicolor flow cytometry. The specificity and sensitivity of the technique have~     been demonstrated in an experimental model. This model consists in using 8 color flow~     cytometry to look for characterizable leukemia cells added in different dilutions to a~     population of isolated ovarian cells taken from model ovarian cortex and up to a dilution of~     10-5. When the molecular markers were present on diagnosis, they were found by RQ-PCR with~     the same dilutions. The model tissue came from laparoscopic ovarian drilling in patients with~     polycystic ovary syndrome. The main objective of this project is to validate techniques that~     have been previously codified with different populations of leukemia cells that may be~     characterized. We then aim to adapt and validate this technique to look for MRD using 8 color~     flow cytometry on cryopreserved fragments of ovarian cortex from leukemia patients that are~     at risk of metastasis. Secondary objectives will be to implement procedures for oncological~     qualification of grafts in cases of malignant pathology and to consider the recommendations~     for using this cryopreserved ovarian tissue through the autograft technique for these~     indications.~   "
51858|NCT02888132|"~     Hypertrophic Obstructive Cardiomyopathy (HOCM) patients have significant clinical symptoms,~     including progressively increasing fatigue, angina, exertional dyspnea, and syncope.~     Conservative medications are used to treat the vast majority of patients. Invasive therapy,~     which includes surgical myectomy, septal ethanol ablation and dual-chamber pacing is~     introduced to patients with refractory symptoms or drug resistance. Considering the~     sternotomy and relatively high patients' tolerance required in myectomy, the potentially~     risky misplacement of ethanol and the anatomic variability of the vascularised hypertrophic~     septum, and the potential risk of conduction block after these two treatments, the~     development of new minimally invasive approach is warranted.~      Previous researches have illustrated the effectiveness and feasibility of transcatheter radio~     frequency ablation for HOCM patients. By far, there has been no report on transthoracic~     laser-induced interstitial thermotherapy (LITT) for human treatment. Since 2004, our~     department has adopted High Intensity Focused Ultrasound, radio frequency and laser in solid~     tumors treatment, including liver tumors and fibroid. Also our center has conducted several~     animal experiments to verify the feasibility of radio frequency/laser in septal myocardium~     ablation.~      The purpose of this study is to lead echocardiography-guided transthoracic radio~     frequency/laser ablation for HOCM ventricular septum, make minimally invasive treatment plans~     for HOCM patients, and verify the safety and validity of intervention treatment in long term.~   "
51859|NCT02888119|"~     This study aims to develop, evaluate and translate highly accelerated imaging sequences (each~     protocol under 5 minutes) for in-vivo knee Osteoarthritis applications on a standard clinical~     3T scanner using novel compression sensing and parallel imaging strategies.The overarching~     objective of the study is to establish a non-invasive imaging biomarker based on the~     development of rapid relaxation mapping with compressed sensing (CS) that will be clinically~     useful for assessment of early Osteoarthritis. A total of 90 subjects including 30 patients~     with high risk of developing knee OA, 30 patients with mild OA and 30 healthy controls will~     be accrued.~   "
51860|NCT02888106|"~     Randomised, Comparative, Parallel-Arm Study to Assess Efficacy and Safety of Myrcludex B in~     Combination with Peginterferon Alfa-2a Versus Peginterferon Alfa-2a Alone in Patients with~     Chronic Viral Hepatitis B with Delta-agent~   "
51861|NCT02888093|"~     Uterosacral ligament suspension (USLS) is a commonly performed, vaginal surgery for the~     correction of female pelvic organ prolapse. The original description of this procedure~     included the use of permanent sutures. However, permanent suture use in this vaginal~     application can result in some minor complication such as persistent vaginal spotting,~     vaginal discharge and dyspareunia. Subsequent reports on this procedure have utilized~     delayed-absorbable sutures in order to avoid these complications. Retrospective studies are~     conflicting as to whether or not absorbable suture provides as durable an anatomic outcome as~     permanent suture. There are currently no high-quality, prospective studies that have~     evaluated outcomes of permanent and absorbable suture for uterosacral ligament suspension.~      This study will recruit women scheduled to undergo USLS with or without other prolapse or~     anti-incontinence procedures. Participants will be randomized 1:1 to permanent or absorbable~     suture. Follow up will occur at 6 weeks and 12 months post-operatively. The primary outcome~     will be Pelvic Organ Prolapse Quantification Exam (POP-Q) point C as measured at the 12 month~     follow up visit. Subjects and assessors will be blinded.~   "
51862|NCT02888080|"~     The purpose of this study is to assess if ACZ885 will improve lung function in association~     with reduction of tissue inflammation in patients with chronic sarcoidosis.~   "
51863|NCT02888067|"~     The purpose of this study is to determine whether deep neuromuscular blockade provides better~     surgical conditions than moderate neuromuscular blockade in patients undergoing vocal cord~     resections requiring jet ventilation.~   "
51864|NCT02888054|"~     This study will assess the bioequivalence (BE) of Lesinurad/Allopurinol Fixed-Dose~     Combination (FDC) Tablets and Coadministered Lesinurad and Allopurinol Tablets in Fed Healthy~     Adult Subjects~   "
51865|NCT02888041|"~     According perinatal surveys, induction of labor is performed at more than 20% of pregnant~     women.~      According to a survey on the trigger practices in France, prostaglandins are widely used to~     initiate cervical ripening, usually by laying intravaginal dinoprostone (Propess®).~      The overall work-up rate due to the use of a single Propess® is 74.6% with 80% of vaginal~     deliveries.~      Currently, 25.4% of patients who was not put in work after 24 hours are triggered by oxytocin~     (Syntocinon®) or directly caesarean. The initial installation of intravaginal dinoprostone~     limits the use of oxytocin (Syntocinon®) or in lower doses.~      Using a second Propess® is carried out in several maternity hospitals, as reported by the~     survey on the cervical ripening practices in France. This second administration could be the~     solution to reduce the rate of caesarean in France which amounted to 20.8%.~   "
51866|NCT02888028|"~     This study investigates whether an additional remote follow-up of patients with implantable~     cardioverter-defibrillators (ICDs) has beneficial effects on Quality of life (QoL), levels of~     anxiety and depression and device acceptance. Patients are randomized to either conventional~     in-office FU only or additional remote surveillance, follow-up duration is 12 months. The~     influence of other variables (age, sex,..) is evaluated regarding their influence on study~     endpoints.~   "
51867|NCT02888015|"~     Pt will be provided with a upper extremity exercise program that will be completed daily~     during their session with occupational therapy. During the session the Activity Measure-Post~     Acute Care and an activity tolerance chart will be completed. The data from the outcome~     measures will be used to determine if there is a benefit to completing a daily exercise~     program.~   "
51868|NCT02888002|"~     A brief treatment program (MI/CBT) via face-to-face or via internet is tested in association~     with an outpatient addictions clinic.~   "
51869|NCT02887989|"~     The study is a randomized controlled trial (RCT) of VR non-opioid management vs. a control~     sham intervention for a broad and representative group of medical and surgical patients~     with pain. Hospitalized patients will receive specialized VR interventions, administered via~     portable VR headsets, to manage breakthrough pain. Control patients will view content on the~     in-room Health and Wellness television channel. Investigators will follow patients throughout~     the course of their hospitalization and monitor outcomes during and after their stays,~     including pain levels, medication requests, and quality of life.~   "
51870|NCT02887976|"~     An Open-label extension (OLE), expanded access study, to assess long-term safety of~     SoluMatrix™ Abiraterone Acetate 500mg (4 x 125 mg qd) with Methylprednisolone (4mg bid) in~     patients who completed study number CHL-AA-201.~   "
51871|NCT02887963|"~     The purpose of this study is to know the prevalence of iron deficiency (ID) and iron~     deficiency anemia (IDA) among pregnant women in Chinese urban district at present, and to~     analyze the epidemiological characteristics of ID/IDA and influencing factors.~   "
51872|NCT02887950|"~     For women aged between 55 and 65 years weight gain is a major health concern. Obesity is an~     important risk factor for multiple diseases (e.g. metabolic syndrome, diabetes mellitus,~     hypertension and cardiovascular disease), and several studies have shown that the transition~     to menopause is associated with adverse changes in body composition. In particular, it is~     common to observe the accumulation of adipose tissue in the abdominal region which is~     believed to be an important determinant of the increase in cardiovascular risk.~      The first-line strategy for weight management in overweight / obese subjects is the~     modification of dietary habits and lifestyle in terms of physical activity. However,~     nowadays, there is also a growing interest in complementary therapies (i.e. herbal~     supplements, acupuncture, etc ...) that can be used alone or in combination to achieve more~     consistent results. In this context, preliminary evidence supports the potential role of some~     compounds of vegetal origin such as resistant starch, epigallocatechin gallate and~     chlorogenic acid as adjuvants of dietary therapy for overweight.~      These nutrients may be an important therapeutic aid for overweight subjects. However, in~     support of their use, the evidence from good quality trials is limited.~   "
51873|NCT02887937|"~     The overarching goal of the proposed research is to evaluate whether qualitative and~     quantitative parameters in real time contrast enhanced ultrasound (CEUS) can aid in assessing~     suspicious indeterminate cystic appearing breast masses and ultimately determine whether or~     not an ultrasound guided biopsy is necessary. The underlying hypothesis is that breast masses~     (given BIRADS 4) that lack enhancement on CEUS will have a benign histology obtained by~     ultrasound guided core biopsy and/or surgery. Then, in the future, these non-enhancing cystic~     lesions can be followed and do not need biopsy intervention.~   "
51874|NCT02887924|"~     Purpose: The investigators hypothesis is that, as compared to the only nCPAP-applied group,~     application of SLI maneuver followed by respiratory support with nCPAP immediately afterwards~     in preterm infants at high risk for RDS would reduce the need for intubation and mechanical~     ventilation in early period and ultimately will improve respiratory outcomes.~   "
51875|NCT02887911|"~     The purpose of this study is to characterize adult subjects regarding their history of~     allergy and asthma, clinical manifestations of asthma, and exposures and conditions that may~     influence asthma severity and control. Assessments include baseline medical history, lung~     function tests, questionnaires and collection of specimens for phenotypic characterization.~   "
51876|NCT02887898|"~     The investigators hypothesize that non-optimal basal-bolus insulin treated patients with type~     2 diabetes can achieve better metabolic control by counting carbohydrates with concurrent use~     of an automated bolus calculator. Additionally, the investigators propose that this~     intervention will lead to improvement in patient related outcomes.~   "
51877|NCT02887885|"~     Sustainability of vaginal ultra-low dose estrogen therapy in postmenopausal women~   "
51878|NCT02887872|"~     Objective: To explore the effectiveness of a combined neuromuscular electrical stimulation~     (ES) and dynamic hand orthosis (DHO) regimen used with a small group of persons with chronic~     stroke in improving ability to perform daily tasks. Method: Four participants with chronic~     stroke participated in the combined ES-DHO regimen using the affected upper extremity (UE)~     five times (5X) per week for 6 weeks. Outcome measures included grip strength, range of~     motion (ROM), and analysis of muscle activation/deactivation during release of grasp through~     electromyography (EMG). Ability to perform daily functional tasks was assessed using the~     Assessment of Motor and Process Skills (AMPS). Results: Preliminary results suggest that~     improvements in strength, ROM and grasp deactivation are possible with the combined ES-DHO~     regimen. Ability to perform daily functional tasks improved in all participants. Conclusion:~     Results should be interpreted cautiously due to the pilot nature of the study and small~     participant number. Further research in this area is warranted.~   "
51879|NCT02887859|"~     This study will evaluate how well Humacyte's Human Acellular Vessel (HAV) works when~     surgically implanted into a leg to improve blood flow in patients with peripheral arterial~     disease (PAD). This study will also evaluate how safe it is to use the HAV in this manner.~   "
51880|NCT02887846|"~     Purpose is to show that HHHFNC method is as effective and safe as nCPAPand even more~     comfortable than it as non-invasive respiratory support for the prevention of extubation~     failure in preterm with gestational age of 26-32 weeks.~      Patients requiring mechanical ventilation for at least 6 hours on the first 7 postnatal days~     will be included in the study.When patients were Fi O2 < 0,40, Pa CO2 < 65 mmHg, pH> 7.20,~     MAP (mean airway pressure) <7 cm H2O, they will be extubated if statistically~     stable.Oxygen-air mixture of 4-6 l / min flow rate will be set in HHHFNC group, and pressure~     will be set to 5-8 cm H2O in NCPAP group. When flow is 2 l / min, FiO2 is<0.30 at 24 hours~     and above, free oxygen will be introduced. In NCPAP group, when pressure is 5 cm H2O and FiO2~     < 0.30 at 24 hours and above, free oxygen will be introduced.~   "
51881|NCT02887833|"~     If cancer spreads to bones it can be very painful, especially when trying to move around. One~     of the best treatments is radiotherapy, which has to be given in a cancer centre. Even with~     this treatment, only about half of people will get good pain relief, and that can take up to~     6 weeks to work fully. If we know who is unlikely to benefit , then we can explore other~     forms of pain relief sooner, without having to go through radiotherapy unnecessarily.~      We have found that there may be a very simple way to identify patients likely to get good~     pain relief, using a test of changes in temperature sensation over the painful bone. This~     study will explore whether this simple bedside test can be used in a community setting to~     identify which patients suffering from cancer induced bone pain will get good pain relief~     from radiotherapy.~   "
51882|NCT02887820|"~     This is a pilot study that seeks to evaluate the feasibility and safety of using a TEG~     algorithm in addition to traditional laboratory tests to guide transfusion and coagulation~     management of ECMO patients.~   "
51883|NCT02887807|"~     Cardiac arrest (CA) is a public health problem in industrialized countries. The prognosis of~     these patients remains poor with significant mortality and severe neurological sequelae in~     survivors.~      The objective of the present study is to determine whether cyclosporine can improve patient~     clinical outcome after shockable CA. 520 patients with CA will be entered into a multicentre,~     randomized, placebo-controlled study. They will receive one single injection of cyclosporine~     (or placebo) prior to resuscitation. The incidence of the combined endpoint (mortality,~     irreversible brain damage informations such as bilateral abolition of N20 wave or absent~     motor response or extension to the nociceptive stimulation…) will be assessed 7 days after~     CA.~   "
51884|NCT02887794|"~     Schizophrenia is a severe psychiatric disorder that affects approximately 1% of the~     population worldwide. Although pathophysiology of this disease remains unclear, a growing~     interest is emerging for low-level sensory function, acknowledging that deficits in early~     stages of sensory processing are related to higher-order cognitive disturbances in~     schizophrenia. In the field of auditory processing, symptoms as auditory-hallucinations were~     found correlated with disabilities to discriminate psychoacoustic parameters of sounds.~   "
51885|NCT02887781|"~     This study aims to investigate the factors (clinical, care-related and genetic) affecting~     renal outcome in patients with TSC (Tuberous sclerosis complex)~   "
51886|NCT02887768|"~     Epicardial Infarct Repair with CorMatrix-Extracellular Matrix (ECM) is an open-label,~     non-randomized, feasibility pilot study. Following ischemic injury the ECM of the heart~     adversely remodels leading to cardiac fibrosis, left ventricular (LV) dilatation and~     subsequent heart failure. Preclinical evidence demonstrates that epicardial infarct repair~     with CorMatrix-ECM restores the damaged ECM, prevents LV dilatation and improves myocardial~     performance. This study will interrogate epicardial infarct repair in patients undergoing~     coronary artery bypass grafting (CABG) surgery within 6 weeks following acute myocardial~     infarction as an adjunct to surgical revascularization. Patients will be evaluated for~     markers of cardiac function and left ventricular remodelling using cardiac magnetic resonance~     imaging (MRI). Adverse events will be monitored to ensure safety.~   "
51887|NCT02887755|"~     The purpose of this study is to test a low cost, non-invasive, wearable near-infrared~     spectroscopy (NIRS) sensor, previously validated for able-bodied athletes as a rehabilitation~     aid for war-fighters with lower extremity limb loss. This sensor can record real-time~     physiologic data that relates to total fitness capacity and exertion levels and may help~     develop individualized programs on a per-patient basis. The uniqueness of this NIRS~     measurement system is that it provides real-time muscular oxygenation, dehydration, and iron~     status during whole-body exercise, as well as training-induced adaptations. Currently, no~     technology like this has been tested in an amputee population. Successfully validating this~     technology in a wounded warrior population would provide vital information regarding tissue~     perfusion after injury and new opportunities for improving rehabilitation outcomes.~   "
51888|NCT02887742|"~     Epidemiologic Study and Impact Study of a Dialysis Solution Change on the~     Electrocardiographic Profile of Patient~   "
51889|NCT02887729|"~     Genkyst is a regional cohort involving up to nephrologists working in private and public~     nephrology centers in the West of France. It registers clinical and molecular genetic data of~     all consenting patients with ADPKD from this area.~   "
51890|NCT02887716|"~     The objective of this study is to describe the change in the percentage of fat in the lumbar~     spine.~   "
51891|NCT02887703|"~     This study evaluates the effectiveness of a 12-week in home balance training program with and~     without sensory augmentation for individuals with ataxia. Subjects wear a belt while~     performing balance exercises three times per week for 12 weeks. The belt measures body motion~     and has small vibrating elements called tactors mounted inside that when turned on, feel like~     a cell phone set to vibrate. The tactors provide information about body motion and indicate~     when and how to make a postural correction. Subjects will receive six weeks of balance~     training with the tactors turned on and six weeks of balance training with the tactors turned~     off.~   "
51892|NCT02887690|"~     The purpose of this study is to optimize the Defense Advanced Research Projects Agency's~     (DARPA) advanced upper limb prosthesis, the Modular Prosthetic Limb (MPL), by evaluating the~     performance, usability, and patient acceptance of the MPL in a clinical setting. This study~     will be a non-randomized limited clinical optimization study. The study will consist of two~     phases. Up to twenty-four upper extremity amputees will be recruited in order to ensure~     twelve subjects for participation in the study: 6 trans-humeral amputees and 6 trans-radial~     amputees. During Phase 1, subjects will be evaluated for their potential to operate the MPL~     using a virtual limb controlled by signals from surface electromyograms (sEMG). The first six~     trans-humeral amputee subjects and the first six trans-radial amputee subjects with a~     demonstrated proficiency controlling the MPL based on analytical performance metrics will~     enter Phase 2. During Phase 2, each subject will be fitted for the prosthesis with a custom~     socket. The user will then evaluate the prosthesis during twelve 1- hour or 1 and one~     half-hour sessions, working with an occupational therapist and research associates and~     completing both quantitative and qualitative assessments.~   "
51901|NCT02887573|"~     Colon capsule endoscopy(CCE) is a new diagnostic method of colonic lesions.It has advantages~     of no requirement for sedation and air insufflation.The bowel preparation has a closely~     relationship with yield of diagnosing diseases.Bowel preparation of CCE is not only to clean~     the colon but also to promote capsule propulsion.Now there is not an optimal method for CCE.~   "
51893|NCT02887677|"~     This study is designed to test the hypothesis that the treatment-induced reductions in the~     ambulatory aortic pressure are more pronounced in the group of dapagliflozin than in the~     group of placebo.~      It is a 12 week, double-blind, randomized, placebo-controlled clinical trial of dapagliflozin~     versus placebo in 160 adult patients with type 2 diabetes mellitus (DM). It will be conducted~     in three centers.~      Potentially eligible patients will be asked to provide written informed consent (Screening~     Visit). Patients, who fulfill the inclusion and exclusion criteria, will be asked to visit~     the sites one week (Visit 1 - V1) after the screening visit. On Visit 2 (V2) all eligible~     patients will be randomized to one of the two treatment arms and will continue with the next~     visits as appropriate (Visit 3, Telephone Visit 1, Visit 4-end of study).~      Aortic blood pressure (BP) and arterial stiffness parameters will be measured as indicated by~     the protocol in V1 and V3 with the Mobil-O-Graph monitor.~      Blood samples will be collected as indicated by the protocol in Screening Visit for the~     measurement of glycated hemoglobin (HbA1c), creatinine and liver function parameters. In~     addition, blood samples will be collected in V1 and V3 for routine hematological and~     biochemical tests including creatinine, fasting glucose, HbA1c, lipid profile and liver~     function parameters.~      Urine samples will be collected as indicated by the protocol in V1 and V3 for the measurement~     of albumin to creatinine ratio.~   "
51894|NCT02887664|"~     Numerous studies have recommended the use of n-3 PUFA supplementation during human pregnancy~     and lactation for the prevention of preterm birth, beneficial effects on fetal development,~     visual and cognitive development and other functional outcomes of the infants.~      The aim of the present study is to assess the correlation between ratio of n-3:n-6 fatty acid~     and inflammation markers in SGA infants compared with appropriate for gestational age (AGA)~     infants. The investigators hypothesize that in SGA infants n-3 and n-6 fatty acid~     concentrations in cord blood will differ from those observed in AGA and might correlate with~     the level of circulating mediators.~   "
51895|NCT02887651|"~     The purpose of this study is to determine whether a local fractionated radiation therapy~     achieves a better local tumor control after complete surgical metastases resection at 6 month~     as compared to observation alone. Further it should be evaluated if cognitive functioning and~     quality of life is similar in both groups.~   "
51896|NCT02887638|"~     Diagnosing and treating posture-related headache (PRH), such as tension-type and cervicogenic~     headache, is seriously hampered because of common features and complex interaction of the~     neurological and musculoskeletal system. Current therapies are therefore not as effective and~     the population of patients with PRH keeps on increasing. The diagnostic as well as the~     therapeutic process need more structure in order to select the most effective treatment;~     thereby contributing to preventive measures. This goal can be achieved through fundamental~     research with a clinically oriented background. Our study starts from a clinical problem,~     with a growing incidence, and is therefore highly relevant. Because sitting-posture seems to~     play an important role in PRH, the first step in the diagnostic process is to analyse~     postural differences between a PRH- and a control-group. In addition, the role of the dura~     mater in the headache-process will be examined. Patients with PRH will be classified in~     homogeneous groups based on these results. In a second phase individual-specific treatment~     programs will be composed. The general treatment-approach of postural abnormalities in the~     past failed because of the heterogeneous patient-populations. Sub-classifying musculoskeletal~     problems has been proven to be successful in the past (O'Sullivan & Dankaerts, non-specific~     low back pain).~      Our study is divided in 2 phases:~        -  phase 1: profile analysis (no intervention, experimental headache-group vs. asymptomatic~          controls)~        -  phase 2: interventional phase (clustered headache-groups, based on the results of phase~          1~   "
51897|NCT02887625|"~     To compare efficacy, safety and durability of combination therapy with pioglitazone plus~     GLP-1 RA versus basal bolus insulin in poorly controlled T2DM patients on metformin plus~     sulfonylurea~   "
51898|NCT02887612|"~     Gastric cancer is one of the common malignant tumors in China, with relatively high incident~     rate and mortality among the population. Surgery is the conventional treatment option for~     early and intermediate-stage stage gastric cancer, but postoperative relapse is the major~     issue. Circulating tumor DNA (ctDNA) is tumor-derived fragmented DNA with an average size of~     166 bp, mixed with cell free DNA (cfDNA) of other sources in blood circulation.ctDNA is~     reflecting the most up-to-date status of tumor genome. Hence, it is considered as a new~     biomarker for tumor, which can be qualitative, quantitative and used for disease monitoring.~     The present clinical trial aims to elucidate the correlation between the serum ctDNA status~     and the prognosis of patients with early and intermediate-stage gastric cancer upon surgical~     treatment, and explore the possibility of clinical utility of serum ctDNA as a clinical index~     to predict postoperative relapse.~   "
51899|NCT02887599|"~     Pancreatic cancer is the 5th leading cause of cancer death and the worst prognostic cancer in~     the world. This is due to high recurrent rate after surgical resection and poor response to~     chemotherapy and radiotherapy.~      Recent studies revealed that peri-tumoral structure and patients' immune status including~     cytotoxic immunity played significant role in the bad behavior of pancreatic cancer. While~     past studies focused on oncogenes and tumor suppressor genes, recent studies focused on~     patients' own immunity. Patients' immunity modified by cancer cells is found to be correlated~     to cancer progression and metastasis.~      Natural killer cells, playing an important role in cytotoxic immune system, are revealed to~     be decreased in patients with lung cancer, ovarian cancer, prostate cancer, colorectal~     cancer, and breast cancer. And in melanoma mouse model, when NK cell was suppressed, cancer~     progression and metastasis were accelerated.~      This study sought to find the correlation of patients' cytotoxic immune status to cancer~     progression and status by measurement of NK cell activity in pancreatic cancer patients. This~     would be basic support to construct a prognostic model of pancreatic cancer for early~     metastasis and post operational recurrence.~   "
51900|NCT02887586|"~     Controlling of cancer induced anorexia is highly demanded by advanced cancer patients. It~     plays an important role in improving the quality of life among advanced cancer patients.~     Through a randomized controlled single blinded clinical research, we will observe the~     differences of appetite, food intake amount, weight and KPS between the auricular needling~     treating group and control group before and after the treatment. Based on the results of the~     research, we can prove the clinical effectiveness of auricular needling in treating cancer~     induced anorexia and possible mechanism of the method.~   "
51902|NCT02887560|"~     The aim of the study is to describe the early adaptation of the right ventricle assessed by~     echocardiography to change of pulmonary circulation secondary to pulmonary transplantation.~      Secondary objectives include change of haemodynamics measured by transpulmonary~     thermodilution and evolution of right heart function in terms of primary graft dysfunction~     grading.~   "
51903|NCT02887547|"~     Gingival Crevicular Fluid samples will be collected using periopapers after accelerated tooth~     movement technique, results will be assessed with biomarkers levels done using ELISA Assays~   "
51904|NCT02887534|"~     A phase 2 randomized clinical trial to evaluate efficacy and safety of SPARC1401 at three~     dose levels in patients with acute low back pain~   "
51905|NCT02887521|"~     This is a study funded by the National Institute of Health. The rationale for the need of~     this research is the lack of any well proven risk-reducing intervention that may decrease the~     morbidity of lung cancer resection in patients with COPD or that may improve their quality of~     life trajectory, a meaningful outcome in the overall disease progression. The proposed~     intervention is unique as it combines exercise and behavioral interventions that were pilot~     tested in a randomized single-blinded controlled design in the proposed population and proved~     feasible and potentially effective. The aim is to test the effect of the proposed~     rehabilitation on length of stay, pulmonary complications and quality of life trajectory.~   "
51906|NCT02887508|"~     The goal of this study was to empirically test a newly developed online HIV sexual risk~     reduction intervention (HINTS) among a representative sample of gay and bisexual men living~     with HIV who meet sex partners online.~   "
51907|NCT02887495|"~     The Scleroderma bioreposiTOry and Pathogenesis Study (STOP Scleroderma) will help researchers~     use clinical data and human biospecimens to investigate why scleroderma patients develop~     certain complications from their disease. Patients with confirmed scleroderma, raynauds or~     positive autoantibodies are invited to participate. This research may help us understand how~     to prevent and treat scleroderma and other diseases.~   "
51908|NCT02887482|"~     The clinical trial will assess the safety, tolerability, and immunogenicity of GLS-5700.~     GLS-5700 is a synthetic DNA plasmid vaccine against the Zika virus. This is a Phase 1~     clinical trial of this vaccine which encodes for the premembrane-membrane and envelope~     regions of Zika virus.~      Zika virus, first discovered in the Zika forest in 1947, has caused a large epidemic in South~     America, Central America, and the Caribbean islands commencing in late 2014 or early 2015.~     Zika virus can cause significant neurologic disease to include Guillain Barre Syndrome in~     adults and microcephaly and other birth defects among children born to mothers who are~     infected during pregnancy. At present no vaccines or treatments have been approved for Zika~     virus infection.~   "
51909|NCT02887469|"~     This study will investigate efficacy and safety of rapid intermittent correction compared~     with slow continuous correction with hypertonic saline in patient with moderately severe or~     severe symptomatic severe hyponatremia~   "
51910|NCT02887456|"~     The maintenance of primary teeth until their exfoliation has been one of the main purposes of~     Pediatric Dentistry, are they representing the fundamental basis for proper occlusion of the~     permanent dentition. Often, injuries or extensive dental caries reach the pulp of deciduous~     teeth making maintenance on these dependent endodontic treatment arc. Thus, this study was to~     conduct a randomized clinical trial is to evaluate the performance of endodontic treatment in~     primary teeth using MTA paste, comparing to Vitapex.~   "
51911|NCT02887443|"~     This phase I open label study is conducted to assess the potential pharmacokinetic~     interaction of Raxone® with midazolam in healthy male volunteers~   "
51912|NCT02887430|"~     The aim of this study was to investigate whether the eight therapy session with foot~     reflexology can reduce pain intensity when applied as an addition to the standards care of~     low back pain according to the Malaysian low back pain management guidelines.~   "
51913|NCT02887417|"~     Glioblastoma face an increased risk of venous or arterial thromboembolism. Furthermore, the~     most frequent immune cells in glioblastoma are tumor associated macrophages, which find~     theirself in an anti-inflammatory (M2) phenotype.~      Increased conjugates between circulating platelets and monocytes reflect an pro-inflammatory~     status.~   "
51914|NCT02887404|"~     Investigators plan to study the role of spine surgery analgesic pathways - for procedures~     with high risk of postoperative pain - in improving the quality of recovery~   "
51915|NCT02887391|"~     Although hemodialysis is life-saving, unfortunately, people on dialysis often have declining~     health, quality of life as well as poor nutritional status. Hemodialysis patients must follow~     a very restrictive diet, and many patients do not eat well and usually report poor appetites.~     A new approach to dialysis is being used in some hospitals in Alberta and elsewhere, called~     in-centre nocturnal hemodialysis. This in-centre nocturnal dialysis allows people to receive~     their dialysis at a hospital or clinic while they sleep. Since this in-centre nocturnal~     dialysis gives people 8-hour hemodialysis treatment 3 times per week (24 hours of dialysis~     per week) the patients have better removal of the waste products from their bodies than~     conventional hemodialysis (an average of 12 hours per week). Also of importance, when using~     in-centre nocturnal dialysis, people will have more time during the day to work, spend with~     family, as well as have time to shop for food, to cook and even to eat, which in turn will~     likely result in improvement in the quality of their lives. This study will follow 10~     patients on conventional dialysis and 10 patients on in-centre nocturnal dialysis for 6~     months and compare their food intake, muscle mass, weight, body mass index (BMI) and~     nutrition-related lab tests. The purpose of this study is to determine whether there is an~     improvement in the nutritional status of the in-centre nocturnal hemodialysis patients~     compared to the nutritional status of conventional hemodialysis patients.~   "
51916|NCT02887378|"~     A cross-over study of the impact of histologic results of bronchial biopsies performed using~     hot clamps compared to bronchial biopsies using standard clamps~   "
51917|NCT02887365|"~     Investigators would like to assess the efficacy and safety of tegafur-uracil in patients with~     stage II MSI-L or MSS colon cancer under metronomic setting for one year.~   "
52044|NCT02885688|"~     The goal of this clinical research study is to learn if adding liquid nutrition therapy that~     is given by vein to standard-of-care treatment for sepsis can help to control sepsis symptoms~     better than giving standard-of-care treatment alone.~      Researchers also want to compare the length of ICU and hospital stay and any side effects~     between these 2 treatments.~   "
51918|NCT02887352|"~     Cognitive impairment affects up to 65% of multiple sclerosis (MS) subjects, especially~     executive functions. The California Card Sorting Task (CCST) assesses specific components of~     problem-solving ability. There is currently no French version of this test. Reims~     neurological department in collaboration with Rothschild Foundation has developed a French~     adaptation of CCST. This version includes three cards packages with two alternate forms to~     control practice effects (test-retest). In order to assess test-retest reliability we have~     to verify the comparability of the three cards packages within one session in MS patients.~   "
51919|NCT02887339|"~     The Ethical, Legal and Social Issues Substudy in relation to the Genotype Tissue Expression~     Project (GTEx) aims to describe tissue requesters' approach to discussions about donation to~     GTEx and to assess the determinants of families' and patients' willingness to donate to GTEx.~     It also explores ethical issues such as privacy, risks, and release of incidental findings~     and recommend best practices for conducting authorizations and training requesters.~   "
51920|NCT02887326|"~     The biomarker study adds to our previous study on biomarkers in tear fluid. In this study the~     investigators examine wether the biomarker levels are in correlation with the disease level~     and duration of disease.~      The questionnaire study focuses on the patients perspective. With a validated questionnaire~     fore keratoconus patient it examine the patients self.-evaluated visual challenges and~     quality of life~   "
51921|NCT02887313|"~     Preoperative 5FU based chemoradiotherapy is still the standard of treatment for locally~     advanced rectal cancer. About 15-20% of patients would achieve pathologic complete response~     (pCR) after neoadjuvant CRT, and the survival outcome was much better than that of non-pCR.~     We aimed to enhance the neoadjuvant treatment, adding mFOLFOX6 during CRT and after~     radiotherapy, to improve the pathologic outcome and the survival outcome.~   "
51922|NCT02887300|"~     Work in a healthcare setting, such as in an emergency department (ED), while rewarding, can~     be harmful to psychological well being, as demonstrated by the high numbers of Irish hospital~     doctors experiencing burnout. Burnout has been linked to poor healthcare quality, medical~     errors and low patient satisfaction. To prevent further escalation of this problem, there is~     a need for effective stress-reducing intervention, such as meditation. Meditation practice~     has a confirmed positive effect on well being; through greater insight and awareness,~     meditation could help ED staff to become more attentive to and understanding of their~     patients' complaints, enhancing patient satisfaction and safety. However, based on current~     research it is difficult to distinguish between the effects of meditation on well being and~     those associated with bringing people together. There is therefore a need for a larger~     randomised study (RCT) including a participants that receive no meditation intervention.~      This pilot study aims to examine the suitability of RCT to assess the effect of mantra~     meditation on burnout among ED staff. The investigators will also examine participant~     recruitment and retention, data management and outcomes assessment methods for well being,~     patient satisfaction and biological markers. There will be two groups: intervention group~     (meditation) and control group (non-meditation). 30 ED staff placed in the intervention group~     will discuss prescribed texts and learn mantra meditation over a 7-week period, accompanied~     by 20 minutes of daily meditation practice. 30 ED staff placed in the control group will work~     in the ED as usual and not receive any texts. Biological samples and questionnaires will be~     obtained at three time points. Participant feedback will also be sought through interviews.~     This study will highlight issues related to participant recruitment, retention, and~     adherence, questionnaires, logistics, and data management and pave the way for an efficient,~     effective, and larger study that will investigate mantra meditation as a means of reducing~     burnout in ED staff.~   "
51923|NCT02887287|"~     The study aimed to prove EEN is effective for inducing early clinical remission, mucosal~     healing, promoting fistula closure and reducing the size of abscess to adult CD patients.~     They plan to include about 50 patients and observe the effect of EEN.~   "
51924|NCT02887274|"~     Persistence of a marked compensatory anti-inflammatory innate immune response after an insult~     is termed immunoparalysis. There is no biomarker available to determine the immune status of~     patient. Thus, the need for early and definite diagnosis of immune status of patient with~     sepsis, as well as the identification of patients at risk of evolving with severe organ~     dysfunctions, is crucial.~      Most important of all, speed is the key to survival. Therefore, it of crucial importance to~     identify which patient characteristic determines the poor prognosis. Early intervention can~     improve the prognosis. Investigators foresee an urgent need to identify predictors for~     mortality in severe sepsis, including clinical factors or immune status. Recently, the PIRO~     model has been proposed as a way of stratifying septic patients according to their~     Predisposing condition, the severity of Infection, the Response to therapy and the degree of~     Organ dysfunction. The immune status may be associated with above model. However, there is~     paucity data addressing this issue. In this study, investigators will also analyze the~     progression of patient condition during treatment and the associated immune status change. In~     the future, Investigators hope the determination of immune status may contribute to this~     model of classification rather than just being used as prognostic markers. Despite the~     advances in the knowledge of the basic processes that trigger and sustain the systemic~     inflammatory response in sepsis, the search for a magic bullet to treat this syndrome has~     been frustrating. The incidence of severe sepsis and septic shock still remains quite high,~     as does its mortality, which has decreased very little over the past decades.~   "
51925|NCT02887261|"~     For esophageal cancer patients,chest CT could provide more accurate staging information and~     eliminated operation that could not achieve R0 resection such as T4 disease. However, the~     variation image quality was usual encountered because of contrast medium was injected via~     peripheral vein. Power injectable port could provide a secure vascular access as~     administration route for contrast medium via central vein. This could provide higher~     intravascular contrast medium concentration and could lead better image quality. This study~     divided into two arms, one group planned to receive power injectable port and another~     received conventional port. The aim of study was tried to identified the image differences~     between different contrast medium administration route and the its survival impact of~     esophageal cancer.~   "
51926|NCT02887248|"~     The purpose of this trial is to determine the benefit of the combination of nab-paclitaxel~     plus gemcitabine given for 6 cycles, followed by maintenance nab-paclitaxel alone, in~     patients with cisplatin-ineligible or cisplatin-incurable advanced urothelial carcinoma (UC).~   "
51927|NCT02887235|"~     The purpose of this study is to determine whether medically tailored meals (HDTM) can improve~     quality of life for patients with metastatic cancer.~   "
51951|NCT02886910|"~     This study evaluates the non-inferiority of a protocol of limited evaluation (complete blood~     count, blood culture) and clinical observation by standardized physical examination versus~     the algorithm suggested in the CDC's 2010 guidelines (limited evaluation, clinical~     observation and antibiotic therapy) in the management of asymptomatic infants born at term to~     mothers with suspected chorioamnionitis. The primary outcome of the study is the difference~     in the prevalence of sepsis-related symptoms between the two groups.~   "
51928|NCT02887222|"~     Until recently, at Mount Sinai Hospital (MSH), epidural analgesia for labor pain was~     delivered with a pump that could only provide continuous infusion of the freezing medication~     in combination of pushes of medication activated by the patient, a technique called patient~     controlled epidural analgesia (PCEA). In the last decade or so, the literature has suggested~     that this continuous infusion of medication is not as effective as previously thought, and~     suggested that instead of continuous infusion we should use intermittent programmed pushes.~     The investigators now have devices that are able to do that. Programmed intermittent epidural~     bolus (PIEB) is a new technological advance based on the concept that boluses of freezing~     medication in the epidural space are superior to continuous epidural infusion (CEI). Recently~     the epidural pumps at MSH were reprogrammed to deliver bolus of medication at regular~     intervals (PIEB), in addition to what the patient can deliver herself (PCEA). Studies have~     shown that delivering analgesia in this manner prolong the duration of analgesia, reduce~     motor block, lower the incidence of breakthrough pain, improve maternal satisfaction and~     decrease local anesthetic consumption. The investigators have recently concluded a study at~     MSH using PIEB where excellent results were observed. However, in that study, some patients~     exhibited higher than necessary sensory blocks. The investigators believe that the technique~     can be optimized by using the same interval of the previous study with smaller volumes of the~     intermittent boluses. Optimizing the technique, may allow the investigators to be able to~     reduce even further the amount of medication used by each patient.~      The hypothesis of this study is that there is an optimal volume of the PIEB bolus at a fixed~     interval of 40 minutes of 0.0625% bupivacaine plus fentanyl 2mcg/ml that will provide 90% of~     women the necessary drug requirements during first stage of labor (EV90), thus avoiding~     breakthrough pain and need for PCEA or physician intervention. We hypothesize that this~     effective volume will be between 7 and 12 mL (6.6 mg/hr to 11.3 mg/hr of bupivacaine).~   "
51929|NCT02887209|"~     Insomnia is a problem for approximately 75% of people living with HIV, which is much higher~     than the 6% to 10% of people with insomnia in the general population. It is currently unknown~     why the rate of insomnia is so high among people living with HIV, and because of this, they~     are often excluded from clinical trials examining the usefulness of cognitive behavioural~     therapy for insomnia (CBT-I), which is recommended as the first-line treatment for insomnia.~     Insomnia is also associated with poorer immune functioning and lower medication adherence.~     The purpose of this study is to examine whether CBT-I is useful at reducing insomnia among~     people living with HIV, and to examine whether this counselling is safe to provide to this~     population. Other purposes are to explore whether reducing insomnia will lead to improved~     immune functioning and medication adherence, to collect feedback about people's experiences~     receiving CBT-I, to examine which psychological and behavioural factors are associated with~     insomnia severity among people living with HIV.~   "
51930|NCT02887196|"~     Twenty-five women will be followed through their breast cancer treatment. The women will be~     asked to provide their opinions and desires for lifestyle intervention at different times~     throughout treatment. In addition, basic clinical data will be collected . The primary goal~     of this pilot study is to investigate the physical and behavioral changes that occur in~     patients receiving treatment for breast cancer.~   "
51931|NCT02887183|"~     This study is to determine early and more chronic changes in concentrations of biomarkers~     related to mechanisms of action (MOA) and effects of sacubitril/valsartan therapyover a~     period of 12 months, and correlate these biomarker changes with cardiac remodeling~     parameters, patient-reported outcomes and cardiovascular outcomes.~   "
51932|NCT02887170|"~     Losing contact with adult suicide attempters in the year after the suicide attempt (SA)~     increases the risk of recurrence. The situation with adolescents is unknown. Investigators~     aimed to determine whether being lost to contact early (LCE) by clinicians is a risk factor~     of longterm SA recurrence among adolescents and the associated factors.~   "
51933|NCT02887157|"~     Retinopathy of prematurity (ROP) is a disorder of development of the neural retina and its~     vasculature that may impact vision in vulnerable preterm neonates for a lifetime. This study~     utilizes new technology to determine visual and neurological development of very preterm~     infants in the intensive care nursery, during a period of rapid growth of the retina, optic~     nerve and brain. The long-term goal of this study is to help improve preterm infant health~     care via objective bedside imaging and analysis that characterizes early critical indicators~     of poor vision, neurological development and ROP, which will rapidly translate to better~     early intervention and improved future vision care.~   "
51934|NCT02887144|"~     The aim of the current Investigation is to evaluate the safety and performance of SenSura~     test product 1pc flat and convex light compared with commercial SenSura.~   "
51935|NCT02887131|"~     The purpose of this study is to describe normal dynamic computed tomography anatomy of hind~     foot in inversion/eversion movement, and to define diagnostic criteria for subtalar~     instability.~   "
51936|NCT02887118|"~     Quantitative and prognostic evaluation of dense red blood cells in sickle cell children:~     preliminary single center study from the Creteil pediatric cohort.~   "
51937|NCT02887105|"~     The purpose is to determine the relationship between anxiety and cognitive performances in~     patients with acute and chronic phases of cerebrovascular accident (CVA). Data from~     neuropsychological assessment concerning cognitive processes (working and episodic memory)~     sensitive to different dimensions of anxiety will be analyzed.~      The secondary purpose is to evaluate how some neurological (hemispherical lateralization of~     lesions), psychological (depression) and demographic (quality of life) variables can increase~     the effects of different dimensions of anxiety on cognitive processes, during the acute~     and/or chronic phase of CVA.~   "
51948|NCT02886962|"~     Guidelines recommend oral anticoagulation with vitamin K antagonists for atrial fibrillation~     whenever the CHADS2VASC score is superior or equal to 2. As there are no specific guidelines~     for the hemodialysis patients with atrial fibrillation, the general guidelines apply.~     However, several retrospective studies suggest that these patients do not benefit from the~     oral anticoagulation regarding the risk of stroke and may even experience more bleedings and~     deaths.~      The aim of this prospective study is to prospectively compare the hemorrhagic and thrombotic~     risks of oral anticoagulation in comparison with no anticoagulation in hemodialysis patients~     with atrial fibrillation.~   "
51949|NCT02886949|"~     This study aims to evaluate the effects of thyroid functions on energy homeostasis and~     inflammation.~   "
51950|NCT02886936|"~     The goal of iFIT Prosthetics, LLC® was to create and commercialize a modular, immediate fit,~     fully adjustable, transtibial prosthesis system suitable for mass production using high~     strength injection molded polymer materials. This goal was achieved and the aim of this~     project is now to conduct a feasibility and effectiveness study and to assess the design of~     the device. The investigators will be fitting up to 50 transtibial amputees that are current~     prosthesis users with the iFIT device. Patients will wear the device for 1 month and evaluate~     for comfort, stability and ease of use as compared to their conventional device.~   "
51938|NCT02887092|"~     Hip and knee osteoarthritis (OA) is an important health problem with a high prevalence and~     significant consequences on functional ability, perceived health, restriction of autonomy and~     handicap. The weight of multimorbidities and their interaction on functional ability and~     perceived health are left unexplored. This project will rely on the cohort KHOALA,~     representative, multiregional, of 881 prevalent cases (symptomatic hip and knee OA).~      Main objective:~        -  to describe the evolution over time of pain, functional ability, social participation~          and quality of life in subjects with hip and knee OA~        -  to identify prognosis factors of disease evolution (socio-demographic, clinical, and~          other health parameters)~        -  to determine interactions with comorbidities, other personal and environmental factors~          (ICF model).~      Concurrent objective: to improve measurement of perceived health specific to hip and knee OA~     by the OAKHQOL by improving its metrologic performances based on item response theory.~      Task 1: To prepare an improved measurement scale, available as a judgment criteria for the~     3rd year of cohort follow up, over the april 2010-march 2012 period, the mini-OAKHQOL Task 2:~     Evaluation of the cohort in 2010-2012 (year 3 of follow up) in a repeated measure design to~     best assess the evolution of perceived health and functional ability over time, and to~     identify stability of deterioration of autonomy. Perspectives: This project targets to~     provide public health deciders with information of good quality to help them manage~     determinants of perceived health in OA subjects, as essential factors to health care resource~     utilization in their various modalities.~   "
51939|NCT02887079|"~     EMBOL-EI (Research Interest antiphospholipid antibody for embolic risk prediction in~     infective endocarditis) is a prospective cohort study with a biological collection.~      The main objective is: to re-evaluate the potential value of antiphospholipid (aPL)~     antibodies as predictors of embolic events in IE in the light of the improved current~     knowledge on these aPL.~      The seconds objectives are: Other plasma biomarkers of hemostasis (coagulation activation~     markers: D-dimer fragment 1 + 2 of prothrombin; endothelial biomarkers: plasma levels of von~     Willebrand factor) will be taken into account in the analysis, and interest in predicting~     embolic risk, alone or in combination with aPL will be investigated.~   "
51940|NCT02887066|"~     The purpose is to build up a data observatory of individuals with thoracic pain evoking acute~     coronary syndrome (ACS). The aim is the characterization of this population of patients~     consulting at emergency department, the evaluation of therapeutic strategies with regard to~     guidelines and the becoming of patients including severe complications and mortality.~   "
51941|NCT02887053|"~     The purpose of this study is to optimize clinical MR protocols and to validate MR acquisition~     parameters.~   "
51942|NCT02887040|"~     Patients ≥ 3 years of age with newly-diagnosed, diffuse, intrinsic pontine glioma will be~     enrolled in this study. However, the primary objectives of this study are to 1) compare~     overall survival, the time from randomization to death from any cause, for study subjects~     3-21 years of age with newly-diagnosed, diffuse, intrinsic pontine glioma who receive~     Antineoplaston therapy (Atengenal + Astugenal) + radiation therapy vs. radiation therapy~     alone and 2) describe the toxicity profile (all subjects) for Antineoplaston therapy +~     radiation therapy vs. radiation therapy alone.~      A secondary objective is to compare progression-free survival for study subjects 3-21 years~     of age with newly-diagnosed, diffuse, intrinsic pontine glioma treated with Antineoplaston~     therapy + radiation therapy vs. radiation therapy alone.~   "
51943|NCT02887027|"~     Multiple studies indicate that exercise is effective in treating depressed mood and reducing~     anxiety sensitivity. As depressive symptoms and anxiety sensitivity are elevated in~     individuals with anxiety and depressive disorders, exercise could help reduce these symptoms~     and aid in the overall treatment of these disorders. This project aims to test an ecological~     momentary exercise intervention (Exercise4Mood) delivered via a mobile phone application in~     individuals with anxiety or depressive disorders. Previous protocols have tested the~     acceptability and usability of Exercise4Mood in healthy participants. In Phase 1 of the~     study, focus groups were conducted to explore the acceptability and usability of the~     Exercise4Mood app. Qualitative feedback was collected and modifications were made to the app~     based on this feedback. In Phase 2 of the study, the Exercise4Mood app was tested in 6~     healthy participants. Preliminary unpublished findings indicate that the app was acceptable~     and promoted increased physical activity. The aim of this protocol is to test the~     acceptability, usability, and efficacy (to improve mood and reduce anxiety) of Exercise4Mood~     in patients with anxiety or depressive disorders.~   "
51944|NCT02887014|"~     To study the impact of providing specific verbal instructions in inpatients (and/or their~     relatives) undergoing colonoscopy on the quality of bowel preparation.~   "
51945|NCT02887001|"~     Incomplete information or poorly communicated to the transitional stages of the patient's~     drug therapy hospitalized cause medication errors. These steps are the admission, transfer~     within the institution and hospital discharge to home or another institution.~      The adequacy of the prescription recommendations of good practice is not always optimal.~      The cost of taking drug therapy and iatrogenic risks preventable drug-related weighs more and~     more heavily in health spending and in the prolongation of hospitalization or re~     hospitalization.~      Clinical pharmacy widely practiced in the Anglo-Saxon countries has demonstrated its~     effectiveness on these three themes; it seems appropriate to assess this practice in the~     environment of the French health system.~   "
51946|NCT02886988|"~     Linear hypertrophic scar is a common surgical problem that can be difficult to manage,~     especially for the median sternotomy scar. Despite high demand for the early intervention to~     prevent and treat surgical scars, there is yet no universal consensus on satisfactory~     treatment. Botulinum toxin type A is a neurotoxin that has been widely and safely used in~     medicine for more than 30 years. It induces chemodenervation through acting on the~     presynaptic neuron to prevent release of acetylcholine, which leads to functional denervation~     of striated muscle for about 6 months after injection. The aim of this randomized controlled~     trial is to evaluate the efficacy of Botulinum toxin type A as a prophylactic treatment in~     the early postoperative of median sternotomy for the purpose of preventing excess scar~     formation.~   "
51947|NCT02886975|"~     The purpose of this study is to determine whether low protein diet and very low protein diet~     supplemented keto-/amino acid is effective in preventing the progression of chronic kidney~     disease (CKD , stage 2 to 5).~   "
52079|NCT02885233|"~     This study evaluates the effectiveness of a web-based fall prevention program called Free~     From Falls Online (FFFO) on people with multiple sclerosis.~   "
51952|NCT02886897|"~     Background: Combinations of dendritic and cytokine-induced killer cell (D-CIK) based adoptive~     immunotherapy and anti-PD-1 antibody may enhance the immune response and stop cancer cells~     from growing.~      Objective: Phase II clinical trial to investigate the safety, clinical activity and toxicity~     of combinations of D-CIK and anti-PD-1 antibody in patients with treatment-refractory solid~     tumors.~      Methodology: Phase II clinical trial in patients with advanced metastatic hepatocellular~     carcinoma, renal cell carcinoma,bladder cancer,colorectal cancer,non-small-cell lung~     cancer,breast cancer and other solid cancers. The D-CIK was isolated from peripheral blood of~     participants,then activated,expanded and incubated with anti-PD-1 antibody before infusion.~     The enough number (1.0-1.5 *10^10 cells) of D-CIK were infused back into participants.~   "
51953|NCT02886884|"~     This is a 16 subject trial to demonstrate the safety of allogeneic hMSCs administered via~     infusion therapy for diabetic subjects with endothelial dysfunction.~   "
51954|NCT02886871|"~     The overall goal of this study is to test personalized mobile phone-based physical activity~     interventions among staff members at the University of California, Berkeley. Most physical~     fitness applications for smartphones and activity trackers use a constant goal for the number~     of steps each day. However, if the step goals are dynamically adjusted according to past~     behavior, then the corresponding goals may encourage individuals to increase their physical~     activity level. This study consists of a randomized controlled trial in which we are~     assessing the efficacy of two different algorithms for calculating personalized goals for the~     number of steps each day.~   "
51955|NCT02886858|"~     While electroconvulsive therapy (ECT) in major depression is effective, high relapse rates~     and cognitive side effects limit its long-term use. There is no consensus about optimal~     continuation pharmacological treatments after a ECT course.~      Adjunction of tDCS to pharmacological continuation treatment after ECT may decrease relapse~     rates.~   "
51956|NCT02886845|"~     The purpose of this study is to determine the frequency of two Single Nucleotide~     Polymorphisms (SNPs) by sanger-sequencing in Breast Cancers and healthy controls .~   "
51957|NCT02886832|"~     The purpose of this study is to assess the efficacy of a Prostate Health formulation on~     scores attained from the I-PSS questionnaire. Safety and tolerability of the formulation will~     also be assessed.~   "
51958|NCT02886819|"~     Aim: Hypothesis of this study was that WBV activates different receptors or reflex pathways~     depend on vibration intensity. Aim of this study was to test this hypothesis.~      Methods: This study was conducted on 11 healthy adults. WBV was applied at various~     frequencies and amplitudes. The right soleus T-reflex latency was determined before and~     during WBV. WBV-IMR latency of the right soleus was determined using two different vibration~     intensity: weak vibration and powerful vibration. T-reflex latency and WBV-IMR latency were~     determined by using cumulated average method.~   "
51959|NCT02886806|"~     Evaluate the feasibility and quality of automated anesthesia, analgesia and fluid management~     based on a combination of several physiological variables (bispectral index [BIS], stroke~     volume [SV], and stroke volume variation [SVV]) using 2 independent physiologic closed-loop~     systems (PCLS) in patients undergoing high risk vascular surgery~   "
51960|NCT02886793|"~     Pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension~     (CTEPH) are serious diseases with poor prognosis despite recent advances. Currently,~     pulmonary hypertension (PH) is considered a cell proliferative disorder, which has not been~     adequately characterized due to the lack of markers. A better understanding of the mechanisms~     that regulate this proliferative disorder will allow the identification of new therapeutic~     targets for HP.~      The objective of the project is to identify cell proliferative processes in severe forms of~     PH. Patients with PAH (n=20), CTEPH (n=20) and healthy controls (n=20) will undergo~     characterization of microRNAs (miRNAs) contained within circulating microparticles (MPs)~     analysis and mitochondrial functionality and FDG-PET to compare cell metabolism in the lungs~     and the right ventricle between patients and controls.~   "
51961|NCT02886780|"~     Obsessive Compulsive Disorder (OCD) often becomes chronic if not treated. Exposure and~     response prevention (ERP) is recommended psychological treatment. The OCD-team at Haukeland~     University hospital has developed a concentrated 4-day treatment format which has been~     evaluated as part of standard care. Next step in the methodological development is to conduct~     a randomized controlled trial where the 4-day format is compared to self-help and waiting~     list. The study will be conducted at Solvang DPS, Sørlandet Hospital. Participants (16 in~     each group) are ordinary patients (>18 yrs) entitled to care in the specialist health care.~   "
51962|NCT02886767|"~     This study examines the effect of skin-to-skin contact between father and newborn on the~     father-neonate attachment relationship. By block randomization, participants were allocated~     to an experimental (n=41) or a control group (n=42).~   "
51963|NCT02886754|"~     Importance: Clinical communication is an important source of medical error and preventable~     adverse events.~      Objective: To determine the effectiveness of proficiency-based progression (PBP) simulation~     training for ISBAR (Identify, Situation, Background, Assessment, Recommendation)~     communication in the deteriorating patient.~      Setting: The study will be conducted in University College Cork, Ireland. Participants: Third~     year undergraduate nursing and fifth year medical students, who are scheduled to undertake~     ISBAR training as part of the National Early Warning Score (NEWS) programme.~      Intervention: Participants will be prospectively randomized to one of three groups before~     undertaking a performance assessment of an ISBAR communication relevant to a deteriorating~     patient in a high fidelity simulation laboratory: HSE group (the national e-learning~     programme only); S group (national e- learning plus simulation training) and PBP group~     (national e-learning plus proficiency-based progression simulation).~      Main outcome and measures: A proficiency benchmark on the performance of ISBAR communication~     in the context of an acutely deteriorating patient.~   "
51964|NCT02886741|"~     In 2011, IHI designed a new campaign to accelerate uptake of evidence-based practices that~     had been shown to prevent surgical site infections (SSI) associated with hip and knee~     arthroplasty. Project JOINTS (Joining Organizations IN Tackling SSIs was a multi-faceted,~     disciplined initiative that used the Rapid Spread Network (defined above), methods and tools~     developed during previous IHI campaigns to influence orthopedic practices and hospitals~     performing hip and knee arthroplasty. Rather than launch nationally as other campaigns have~     done, Project JOINTS was introduced in a cluster-randomized fashion to enable a rigorous,~     independent evaluation of its effectiveness in promoting uptake of new evidence-based~     practices.~   "
51968|NCT02886689|"~     C.O.R.P.U.S. is the first French observatory of care practices in active inflammatory~     rheumatism of children and adults: rheumatoid arthritis, spondylarthropathy, and idiopathic~     juvenile arthritis, established under the auspices of national health authorities.~      Its goal is to document safety, effectiveness in routine practice of various therapy,~     including biotherapy, of prescription or non-prescription over 5 years.~      A cohort will be constituted including any new case of active disease (DAS 28 > 3,2, BASDAI >~     4, failure of methotrexate), without previous prescription of biotherapy. Therefore, it will~     be possible to have patients non exposed to biotherapy (non indication, refusal,~     contraindication) compared to patients exposed to biotherapy, and to monitor adverse events~     occurrence as well as effectiveness in routine practice over time, according to prescription,~     maintenance or switch of various therapies.~   "
51969|NCT02886676|"~     Introduction- Oxidative stress plays a causative role in pathogenesis of periodontal disease.~      It has been reported that Spirulina platensis or its active ingredient C phycocyanin (CPC)~     exerts anti-inflammatory, anti-oxidative and inhibitory effects on prostaglandin and~     leukotriene biosynthesis.~      Aim- To evaluate the effect of dietary spirulina as an adjunct to SRP on salivary~     antioxidants level in CP subjects.~      Materials And Methods- The study was a randomized double-blind clinical and biochemical trial~     in which 70 subjects with CP in the age group of 40-55 years, reporting to Department of~     Periodontology, TKDC and RC, New Pargaon, were equally and randomly divided into Test Group~     (TG) and Control Group (CG). TG was given 2 gm Spirulina capsules daily, after meals for 1~     month and CG was not given any supplementary diet. SRP was done at baseline in TG and CG.~     Whole saliva sample was collected. Clinical and biochemical parameters will be recorded at~     baseline, 1 month & 3 months.~   "
51970|NCT02886663|"~     This study will assess the effectiveness of a stimulus, in the blind field of hemianopsic~     patients, to restore the vision of patients with homonymous hemianopsia consecutive to stroke~     (unilateral occipital lesion). Hemianopsia occurs in 30% of strokes regardless of the~     cerebral localization and in 60% of stroke interesting the territory of the posterior~     cerebral artery.~   "
51971|NCT02886650|"~     When focal epilepsies become drug-resistant, it could be eligible for cortical surgical~     resection. Therefore, an invasive EEG monitoring with depth electrodes is often needed during~     presurgical evaluation. Some of these children can have access to thermocoagulation inside~     the ictal onset zone, at the end of the monitoring and before to remove the electrodes. These~     thermocoagulations can disorganize the epileptogenic network thanks to millimetric cortical~     lesions around the electrodes. The aim is to stop or at least, to reduce the seizure~     frequency for few weeks or months. This could be a benefit for the child, and also a~     confirmation of the ictal onset zone and guide the surgeon. This technique is currently used~     in adult population for years, but remains very rare in children.~   "
51972|NCT02886637|"~     The purpose of the present study is to evaluate the effects of immune function on prognositic~     outcome in critical ill patients with Acinetobacter baumannii infection.~   "
51973|NCT02886624|"~     The purpose of this study is to assess the rate of sustained virological response (SVR) 12~     weeks after 8-week oral treatment with grazoprevir 100mg/elbasvir 50mg (MRK-combo) in~     patients with acute hepatitis C genotype1 or 4.~   "
51974|NCT02886611|"~     The study aims at searching for a genotype-phenotype correlation in patients with a genetic~     pathology of the ocular surface, in order to identify genetic abnormalities associated with~     the most severe clinical situations.~   "
51975|NCT02886598|"~     The purpose of this study is to assess the safety and efficacy of Firmagon® (degarelix) for~     injection under the conditions of general clinical practice in Korea.~   "
51976|NCT02886585|"~     This research study is studying Pembrolizumab as a possible treatment for this diagnosis for~     metastases in the central nervous system (brain and spinal cord).~   "
51977|NCT02886572|"~     The purpose of this study is to determine the effectiveness and efficiency of Single~     Isocenter Multi-target Stereotactic Radiosurgery (SIMT SRS) in patients with four or more~     brain metastases~   "
51978|NCT02886559|"~     Despite advances in understanding the complexities of acute myeloid leukaemia (AML), the~     treatment of refractory or relapsed AML (rrAML) remains a daunting clinical challenge.The~     investigators designed a new regimen, including chidamide, decitabine, aclarubincin,~     cytarabine and G-CSF, to treat rrAML.~   "
51979|NCT02886546|"~     Robot-assisted laparoscopic prostatectomy (RALP) is widely performed due to its many~     advantages, including a reduced need for blood transfusion and fewer surgical complications~     compared with conventional open prostatectomy. As this approach is also recommended in~     elderly patients with serious comorbidities, optimal fluid therapy guidance during this~     procedure is important.~      Dynamic variables such as pulse pressure variation (PPV) and stroke volume variation (SVV)~     are used to predict and guide fluid therapy during controlled ventilation. These variables~     arise from heart-lung interactions during positive pressure ventilation, which influence left~     ventricular stroke volume (SV). RALP requires carbon dioxide insufflation and the steep~     Trendelenburg position to optimise surgical conditions, and can reduce cardiac output and~     respiratory compliance. Accordingly, the usefulness of PPV and SVV, which are affected by~     changes in intrathoracic pressure, in predicting fluid responsiveness during laparoscopic~     surgery under these conditions may be questioned. A recent study established that PPV and SVV~     derived by uncalibrated pulse contour analysis had a relatively poor capacity to predict~     fluid responsiveness during laparoscopy on dynamic preload indices. In contrast, another~     study SVV measured by oesophageal Doppler monitor (ODM) could predict fluid responsiveness~     during laparoscopic surgery.~      The CardioQ-ODM+ combines the proven ODM Doppler measurement of blood flow with pulse contour~     analysis, which is quickly and easily calibrated from the Doppler signal. We hypothesized~     that PPV and SVV measured by calibrated pulse contour analysis would be a good indicator of~     fluid responsiveness during laparoscopy with pneumoperitoneum.~      The primary objective of this study was to demonstrate that PPV and SVV measured by~     calibrated pulse contour analysis of CardioQ-ODM+ can accurately predict fluid responsiveness~     during RALP, which involves both pneumoperitoneum and the Trendelenburg position.~     Investigators also assessed the capacity of other dynamic variables (SPV [systolic pressure~     variation], and SVV determined by ODM Doppler flow, dynamic elastance [PPV/SVV] and corrected~     flow time [FTc]) to predict fluid responsiveness during RALP.~   "
51980|NCT02886533|"~     Prospective, multicenter, observational study with a three-year inclusion period (from~     January 1, 2012 to December 31, 2015) and a 6-month follow-up~   "
51981|NCT02886520|"~     This study evaluates the effectiveness and complications of polyvinylidene fluoride (PVDF)~     and polypropylene (PP) transobturator suburethral tapes (TOTs) in the treatment of female~     stress urinary incontinence. Half of participants will be operated with PVDF-TOTs, while the~     other half will be operated with PP ones.~   "
52045|NCT02885675|"~     To evaluate the correlation between the value of miRNA related to ARDS and vascular~     endothelial cell and ARDS severity, vascular endothelial cell damaging degree，mortality in~     patients with ARDS.~   "
52046|NCT02885662|"~     To examine antihypertensive effect and safety of CS-3150 in patients with primary~     aldosteronism.~   "
51982|NCT02886507|"~     This is a randomized double-blinded placebo-controlled study to evaluate the effects of~     NSK-SD consumption in subjects with Stage I hypertension.~      The study population will be randomized into two groups, where both groups will receive~     dietary and lifestyle recommendations to help reduce hypertension. One group will receive~     placebo and the other group NSK-SD for 8 weeks.~      The endpoint will be the change in systolic and diastolic blood pressure after 8 weeks of~     treatment in the two subject groups.~   "
51983|NCT02886494|"~     A Randomized, Double-Blind, Vehicle-Controlled, Parallel, Phase II Study to Evaluate Efficacy~     and Safety of BAC in Patient with Alzheimer's Disease or Vascular Dementia~   "
51984|NCT02886481|"~     Paralysis of the recurrent (or inferior) laryngeal nerve (RLN or ILN) is one of the most~     common and most serious complications of thyroid surgery. Neuromonitoring of the inferior~     laryngeal nerve (ILN or recurrent) is a technique currently used during thyroidectomy to~     locate ILN during dissection. Detector electrodes are placed in contact with vocal muscle~     which is stimulated electrically at the location of ILN, producing an acoustic and visual~     signal. This is a basic electromyographic technique whose diagnostic and prognostic potential~     for the entire neuromuscular system has not yet been fully explored. The study of action~     potentials generated by the stimulation-detection of nerves ILN and vagal nerves at the~     beginning and end of dissection, notably the decrease in amplitude, could allow a diagnosis~     during the course of surgery making it possible to diagnose lesions of the nerve and guide~     the surgeon in his surgical decisions, thus avoiding the risk of bilateral recurrent~     paralysis. It could also enable the surgeon to give a prognosis for functional recovery.~   "
51985|NCT02886468|"~     Anaphylaxis is a serious allergic reaction that is rapid in onset and may cause death.~     Although there are several causes of fatal anaphylaxis, food allergy is one of the most~     common. Epinephrine is recommended as the initial treatment of choice for anaphylaxis. A~     delay in epinephrine administration may contribute to an increased risk of death. Therefore,~     the World Allergy Organization recommends that, for the treatment of anaphylaxis, epinephrine~     solution be administered intramuscularly in the mid-anterolateral thigh.~      In France 3 auto-injector pens are available: Anapen®, Epipen® and Jext®. For weight> 30 kg,~     the devices have a needle size respectively of 7.49 mm, 15.02 mm and 15.36 mm. For the~     weights between 15 and 30 kg needle size is 7.49 mm to 12.7 mm and Anapen® for Epipen® and~     Jext®.~      Several studies suggest that the needle length needle is sometim~   "
51986|NCT02886455|"~     The study investigates the impact real output has on peristomal skin covered by a newly~     developed adhesive and a standard adhesive.~   "
51987|NCT02886442|"~     This study investigates the impact of real output on the adhesion of two adhesives.~   "
51988|NCT02886429|"~     Postoperative pain is the most undesired consequence of surgery, and if not managed~     adequately, can lead to delayed recovery and increased hospital stay. Surveys continue to~     reveal that postoperative pain is insufficiently managed throughout the first world, let~     alone in the Third World. An American survey over 20 years showed that only one in four~     patients had adequate relief of postoperative pain. This has led recovery room protocols to~     include pain as a fifth vital sign that needs to be addressed before patients are discharged~     to the ward~   "
51989|NCT02886416|"~     The objective is to characterize the viral evolution and viral factors determining HIV~     virulence, the evolution of the HIV reservoir in PBMC and the co-evolution of anti-HIV CD8 T~     cell repertoires. The coordinated study of virus evolution, host responses and identification~     of genetic determinants of virulence should allow to better understand mechanisms of HIV~     pathogenicity and persistence of mutations in viral reservoirs.~   "
51990|NCT02886403|"~     The study investigates the impact real output has on the adhesion of adhesives.~   "
51991|NCT02886390|"~     The purpose of this study is to determine whether remote limb ischemic conditioning(RIC)~     increase the risk of intracranial hemorrhage for the acute ischemic stroke patients who~     received r-tPA thrombolytic therapy.~   "
51992|NCT02886377|"~     To evaluate the optical coherence tomography (OCT), visual field (VF), Visual evoked~     po-tential(VEP) characteristics between neuromyelitis optica- related optic neuritis~     (NMOSD-ON) and multiple sclerosis- related ON (MS-ON) in a Chinese cohort.~   "
51993|NCT02886364|"~     The purpose of this mixed methods study is to evaluate the implementation of an adapted Safe~     Childbirth Checklist in a rural hospital in Chiapas, Mexico. The study aims are:~        1. To evaluate the implementation of the adapted Safe Childbirth Checklist using quality of~          care indicators and the perspectives of providers and patients;~        2. To examine changes in the perceptions of disrespectful and respectful practices around~          childbirth among providers before and after a quality improvement program.~        3. To understand how postpartum women and their male partners perceive the care they~          received at the hospitals in Ángel Albino Corzo and Revolución with regard to~          disrespectful and respectful practices, and how, if at all, these experiences compare~          with prior birth experiences in other settings.~        4. To examine trends in proportion of facility-based births in the catchment area of the~          hospital after the implementation of the adapted Safe Childbirth Checklist~   "
51994|NCT02886351|"~     The use of nitrous oxide as a sedative agent is very common in pediatric dentistry. In~     concentrations up to 50% it is considered as mild sedation and it is very safe. Despite its~     safety and widespread of its use nitrous oxide is not a potent drug and many times dentists~     fail to gain cooperation in moderate or high anxious children, and the alternatives are to~     use moderate sedation with drugs such as Midazolam, Atarax or general anesthesia. Higher~     concentration was not conducted in Pediatry densitery. The aim of this study is to compare~     the effectivity and safety of providing nitrous oxide at increasing concentrations 60%, 70%~     with 50% parameters, sedation depth, adverse events and cooperation of the child during the~     dental treatment.Our hypothesis is that nitrous oxide in concentrations higher than 50% up to~     70% is a safe and effective sedation method in dental treatment of children.~   "
51995|NCT02886338|"~     External control of capsule endoscopy (CE) by means of an applied magnetic field is a~     possible way to maneuver the movement of CE in gastrointestinal (GI) tract. The aim of this~     study was to evaluate the safety and feasibility of magnetic maneuvering of a capsule~     endoscope in the upper gastrointestinal tract, including the esophagus, stomach and duodenum~     in healthy subjects.~   "
52080|NCT02885220|"~     The aim of our study is to determine if the goal directed weight loss program improves weight~     loss versus the conventional weight loss program after laparoscopic sleeve gastrectomy.~   "
51997|NCT02886312|"~     This study will evaluate patient comfort and oxygen delivery efficiency when providing~     supplemental oxygen through a nasal cannula to volunteers using an instrumented oxygen~     delivery system. The goals of the study are to evaluate different oxygen flow rates and~     oxygen delivery modes. In addition, the investigators will investigate if the system can~     detect apnea (cessation of breathing) and removal of the nasal cannula. The investigators~     will also investigate how well high flow oxygen delivered only during inspiration is~     tolerated and how much the end-tidal oxygen increases after two minutes of high oxygen flow~     delivered only during the inhalation phase of the breath.~   "
51998|NCT02886299|"~     Sixty chronic hemodialysis patients were randomly assigned to receive fenofibrate 100 mg~     (group 1, n = 30) or simvastatin 20 mg (group 2, n = 30) three times/week after their~     dialysis session. The safety and efficacy of drugs on lipid profile, oxidized low density~     lipoproteins (ox-LDL), glutathione peroxidase (GSH-Px) and C-reactive protein (CRP) were~     compared before and after 16-week treatment.~   "
51999|NCT02886286|"~     The purpose of this study is to determine whether the local anesthetic bupivacaine delivered~     intrathecally in small doses via PTM self-administered boluses significantly improves the~     breakthrough pain and functional status of patients with chronic intractable pain who are~     managed with an intrathecal drug delivery system.~   "
52000|NCT02886273|"~     Sudden cardiac death (SCD) accounts for approximately 15 percent of the total mortality in~     industrialized countries, and most commonly results from cardiac arrest due to ventricular~     fibrillation (VF). VF can appear both with identifiable heart disease and as an idiopathic~     arrhythmia. The most commonly underlying heart disease associated with out-of-hospital~     cardiac arrest (OHCA) is coronary artery disease (CAD).~      In this study the investigators intend to give a thorough description of the study population~     based on demographic data, clinical information, medical history and biochemical parameters.~     The investigators plan to assess the total number of OHCA cases among patients reported to~     the ambulance service in the local region during the study period, and determine the~     proportion with documented VF. Next the investigators need to evaluate the clinical baseline~     profile of those included in the study as compared to that of the total VF population. High~     sensitivity cardiac Troponin T cTnT) and brain natriuretic peptide (BNP) will be added to the~     baseline data for further classification of the included SCA patients.~      The main aim of the study will be to evaluate the diagnostic value of copeptin in the setting~     of sudden cardiac arrest (SCA).~      As a second aim the investigators intend to evaluate the association between VF and the~     content of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in red blood cells.~      Furthermore, as vitamin D is associated with n-3 fatty polyunsaturated acids (n-3 PUFAs) in~     the diet, the third aim will be to assess the association between 25-hydroxy (OH)-vitamin D~     and VF. Matched MI patients will be selected for comparison.~   "
52001|NCT02886260|"~     This study aims to:~        1. describe the monitoring of patients treated for spinal disorders.~        2. create a comprehensive database of reliable and readily exploitable quickly to produce a~          library of cross publications between orthopedic surgery and neurosurgical services.~          This database will include clinical, functional , radiographic , educational, social and~          professional data.~        3. obtain a cohort of patients in the comprehensive range of spinal pathologies.~        4. standardize data collection in this cohort with similar national projects.~   "
52002|NCT02886247|"~     The NFPTR was established in 1994 to find the causes of pancreatic cancer. In brief, the~     investigators are interested in both the genetic and non-genetic causes of pancreatic cancer.~     The investigators are particularly interested in finding the genes that cause pancreatic~     cancer to cluster in some families. Up to 10% of pancreatic cancer patients have another~     close relative who has also developed pancreatic cancer. This clustering of pancreatic~     cancers in families has yet to be explained; however, the investigators continue to identify~     new familial pancreatic cancer genes that explain this clustering in subsets of families. For~     example, in 2009 and 2012 the investigators discovered that mutations in the PALB2 and ATM~     genes jointly account up to 5% of the clustering of pancreatic cancer in families.~   "
52003|NCT02886234|"~     This study will investigate whether phone-delivered mindfulness training is feasible and~     acceptable for persons living with HIV and whether it may help them improve adherence to~     medications and reduce risky sexual behaviors.~   "
52004|NCT02886221|"~     Minimally invasive surgery (MIS) represents one of the most innovative surgical treatments of~     Hallux Valgus (HV). However, long-term outcomes still remain a matter of discussion within~     the orthopaedic community. The purpose of this longitudinal prospective study was to evaluate~     radiographic and functional outcomes in patients with mild-to-severe HV who underwent~     Reverdin-Isham and Akin percutaneous osteotomy, following exostosectomy and lateral release.~   "
52005|NCT02886208|"~     This study is a collaboration between investigators and two community partners: a youth~     employment program and an urban farm. The community partners hire 300+ adolescents for summer~     jobs at various organizations. Approximately 120 adolescents will be employed with the urban~     farm site. As one component of their program evaluation plan, investigators will evaluate~     change in BMI of participants. The investigators hypothesize that there will be a reduction~     in BMI of those participants working at the urban farm site.~   "
52006|NCT02886195|"~     The aim of this study was to compare the efficacy of EGFR-TKIs(Epidermal Growth Factor~     Receptor-Tyrosine Kinase Inhibitors) treatment plus concurrent chemotherapy versus sequential~     treatment with EGFR-TKIs and chemotherapy in patients with EGFR(Epidermal Growth Factor~     Receptor)-mutant non-small-cell lung cancer (NSCLC).~   "
52007|NCT02886182|"~     To date, several studies have manifested that high levels of adrenal corticosteroids and~     oestrogen hormones during pregnancy can lead to increased HBV viraemia. These hormonal and~     immune function status changes can result in minimal fluctuations in liver function tests.~     Serum alanine aminotransferase (ALT) tends to increase in late pregnancy and the postpartum~     period. Peripartum hepatitis flares leading to hepatic decompensation have been~     reported.Therefore, the investigators aim to detect and observe the immune function status~     and incidence of hepatitis in pregnant women with chronic hepatitis B virus infection in late~     pregnancy and the postpartum period.To provide a clinical evidence for the administration of~     chronic hepatitis B virus infection pregnant women.~   "
54582|NCT02852525|"~     The purpose of this study is to further validate the use of probe-based confocal laser~     endomicroscopy (pCLE) for the evaluation of Barrett's Esophagus and associated neoplasia in a~     larger patient base.~   "
52008|NCT02886169|"~     The postprandial state increases triglyceride-rich lipoproteins and lipopolysaccharide (LPS)~     levels, promoting cellular lipids accumulation, insulin resistance, increased inflammatory~     markers and the formation of foam cells, a situation that can have different effects~     depending the type of dietary fat and presence of metabolic conditions such as abdominal~     obesity and insulin resistance.~      Given that the diet of the Colombian population is rich in saturated fats, and taking into~     consideration the general resistance to complex dietary changes, the purpose of this study is~     to evaluate whether Sacha Inchi oil supplementation of a high-fat meal is effective in~     reducing levels of biochemical markers of cardiovascular risk in adults with and without~     abdominal obesity.~   "
52009|NCT02886156|"~     Multiple clinical studies have indicated that obstructive sleep apnea (OSA), the most common~     chronic sleep disorder, may affect neurocognitive function, and that treatment for continuous~     positive airway pressure (CPAP) has some neurocognitive protective effects against the~     adverse effects of OSA. However, the effects of CPAP treatment on neurocognitive architecture~     and function remain unclear. Therefore, this multicenter trial was designed to investigate~     whether and when neurocognitive architecture and function in patients with OSA can be~     improved by CPAP treatment, and to explore the role of gut microbiota in improving~     neurocognitive function during treatment.This study will be a multicenter, randomized,~     controlled trial with allocation concealment and assessor blinding. A total of 148 eligible~     patients with severe OSA will be enrolled from five sleep centers, and randomized to receive~     CPAP with best supportive care (BSC) intervention or BSC intervention alone. Cognitive~     function, structure and function of brain regions, gut microbiota, metabolites, biochemical~     variables, electrocardiography, echocardiography, pulmonary function, and arterial stiffness~     will be assessed at baseline before randomization and at 3, 6, and 12 months. In addition,~     the investigators will enroll 74 healthy controls and assess all of the aforementioned~     variables at baseline.~   "
52010|NCT02886143|"~     Urinary retention is a common problem, particularly in hospitalized patients. When a Foley~     catheter is removed, a patient must be monitored for urinary retention. The usual method is a~     passive voiding trial where the catheter is removed, the bladder fills with urine and the~     patient is monitored for voiding over approximately 6 hours. Another option is an active~     voiding trial where the bladder is filled with saline before the catheter is removed and the~     patient is immediately assisted to void. This study seeks to determine the effect of active~     vs passive voiding trials on time to hospital discharge, rate of urinary tract infections,~     and rate or urinary retention in the general hospitalized population.~   "
52011|NCT02886130|"~     In order to attain the elite level on the national scene, volleyball players need several~     attributes. In addition to mastering technical and tactical skills, great jumping ability is~     another important asset. Maximal power output needed to achieve height during a jump~     necessitates coordinated neuromuscular recruitment and muscle mass among others.~     Interestingly, there are claims that alpha-glycerylphosphorylcholine (A-GPC) increases~     acetylcholine synthesis and enhances exercise-induced increases in plasma growth hormone~     concentrations, two factors that could theoretically be associated neuromuscular transmission~     and muscle mass.~      However, until now only a few studies have investigated the role of A-GPC in human exercise~     performance. Published results were mixed. One recent study showed that isometric peak force~     was slightly but significantly increased when subjects had ingested a daily dose of 600 mg of~     A-GPC over a period of 6 days (Bellar et al., JISSN, 2015).~      The objective of our study is to evaluate the longer-term effects (4 weeks) using a higher~     dose (1000 mg/day) of A-GPC on jumping capabilities in elite male and female volleyball~     players.~   "
52012|NCT02886117|"~     The main objective of this study is to determine the capacity of a questionnaire to predict a~     normal balance sheet of haemostasis.~   "
52013|NCT02886104|"~     The surgical and local ablation strategy for the treatment of resectable synchronous and~     metachronous colorectal liver metastases(CRLM) has not still been defined. The purpose of~     this study is to compare two treatment strategies in which simultaneous resection of both~     primary and secondary tumor of synchronous CRLM(SCRLM) and resection of metachronous~     CRLM(MCRLM) is compared with resection of primary tumor and ablation of secondary tumor in~     SCRLM and ablation of MCRLM. Endpoints include the rate of severe complications and survival.~   "
52014|NCT02886091|"~     Treatment of keloids scars is difficult and controversial. These keloids have a functional~     and aesthetic impact. A lot of treatment are described with a lot of relapses and~     aggravation. Authors report outcomes of the treatment with shaving and cryosurgery~   "
52015|NCT02886078|"~     The primary objective is to investigate the active extension six months after implantation of~     the CapFlex-PIP© arthroplasty, comparing the dorsal with the volar approach.~      This is a randomized controlled trial including 70 patients with PIP OA indicated for CapFlex~     arthroplasty.~   "
52016|NCT02886065|"~     This research study is studying a targeted therapy as a possible treatment for Smoldering~     Multiple Myeloma.~      The following intervention will be involved in this study:~        -  Lenalidomide~        -  Durvalumab~        -  PVX-410~   "
52017|NCT02886052|"~     The purpose of this project is to evaluate an Internet-based Cognitive Behavioral Therapy~     (ICBT) for bereaved parents with insomnia. Participants are randomized to either a therapist~     guided ICBT or to an active control who receives written information on sleep, insomnia, and~     sleep hygiene. The primary purpose is to evaluate changes in insomnia severity for treatment~     compared control, after treatment and at 9 and 18 months follow up. A secondary purpose is to~     evaluate changes in symptoms of complicated grief and depression.~   "
52018|NCT02886039|"~     Cardiac arrest (CA) is a major public health problem (1) because of its frequency (30000 to~     50000 new cases of CA per year in France), a high mortality 80-90% and a relevant morbidity :~     50% of survivors have cerebral sequela. Neurologic prognostication after CA is paramount. The~     American Academy of Neurology identifies accurate predictors of poor neurologic outcome (2):~     clinical examination findings such as no pupil response, no corneal reflexes, no motor~     response to stimulation and early myoclonus status epilepticus; biologic parameters like high~     neuron specific enolase (NSE) greater than 33 μg/L (3-4) and electrophysiologic results like~     flat electroencephalogram (EEG) or with burst suppression and Somatosensory evoked potentials~     (SEP) with no response to N20. Brain imaging may provide additional informations but not~     recommended yet. However, these pronotic markers were developed before the introduction~     therapeutic hypothermia (TH) (5-6). TH is now recommended after cardiac arrest by~     international guidelines, based on demonstration of improved survival and neurological~     recovery in comatose survivors of CA (7). TH and its associated use of sedative and paralytic~     agent may delay neurologic recovery and affect the optimal timing of prognostic variables~     (8).~      Many classifications of electroencephalogram (EEG) (9-12) exist but no one is generally~     accept and recommended and they were created before TH.~      In a preliminary study based on a retrospective cohort of 64 patients in CA with initial TH,~     we developped an electroencephalographic score to predict precocity the neurologic outcome~     according to the Cerebral performance category (CPC) (13-14).~      The purpose of this study is to evaluate a simple and objective electroencephalographic score~     helpful to predict neurologic outcome after CA. Then, we would like to create a composite~     score to have a multimodal prognostication.~      Patients and methods After CA resuscitation, all patients underwent coronary angioplasty if~     indicated and then were immediately admitted in emergency room of ICU. All patients were~     intubated and mechanically ventilated. Sedation was performed with continuous infusion of~     midazolam 0,15-0,2 mg/kg/h and sufentanil 0,15-0,2 μg/kg/h. All our patients were curarized~     with cisatracurium 0,2-0,3 mg/kg/h to prevent shivering during TH and took anti-epileptic~     medication phenobarbital 10-15 mg/ kg two times a day to prevent infra-clinic convulsive~     seizure.~      Mild TH between 33 -34 °C was performed by active cooling with intravascular device~     (CoolGard® - Zoll, Chelmsford, UK) for 24 hours. Mean arterial pressure was maintained~     between [75-80] mmHg by titrated norepinephrine with or without inotropics (dobutamine,~     epinephrine) according cardiac output monitored by echocardiography.~      After 24 hours of hypothermia, warming was started at a rate of 0.2 ° C/hr; neuromuscular~     blocking agents were arrested at 35.5°C and sedation at 36.5°C.~      Neurological evaluation performed at 48 hours off sedation included a clinical evaluation~     (Glasgow score, myoclonus status, response to orders, motor response to stimulation,~     brain-stem reflexes). NSE was sampled between 48 and 72 H. EEGs were performed at Day-2,~     Day-3 and Day-5 off sedation and SEP at Day-5 off sedation. All EEGs were interpreted by two~     certified electroencephalographers blind from clinical neurologic outcome.~      Survival and neurologic outcome according to CPC were assessed at ICU discharge and three~     months later.~   "
52019|NCT02886026|"~     This study compare the efficacy of conventional photodynamic (PDD) guided transurethral~     bladder tumor resection in the operating theatre with outpatient PDD guided laser destruction~     of bladder tumors through flexible cystoscopes.~   "
52047|NCT02885649|"~     This pilot phase 0 trial studies how well enzalutamide works before surgery in treating~     patients with kidney cancer. Androgens are a type of hormone produced by the body that may~     cause kidney tumors to grow. Anti-hormone therapy, such as enzalutamide, may lessen the~     amount of androgens produced by the body and keep kidney tumors from growing.~   "
52698|NCT02877173|"~     A phase II,randomized,double-blind,multi-doses,positive drug parallel controlled,multi-center~     clinical trial to evaluate initially the efficacy and safety of alprostadil liposomes for~     injection in the treatment of atherosclerotic occlusive disease of the lower extremities.~   "
52020|NCT02886013|"~     Background and Aims: The presence of the FTO rs9939609 and PPARy rs1801282 polymorphisms~     suggests changes in energy metabolism; this variation may be responsible for the development~     of various diseases including obesity. The aim of this study was to identify the presence of~     these polymorphisms in Mexican adolescents with overweight and obesity at high risk for~     developing diabetes. Methods and Results: This was a descriptive cross-sectional study, where~     71 healthy adolescents (average age of 16) were included. Anthropometric measurements, Body~     mass index, as well as the determination of glucose, insulin and HOMA index were calculated~     from all the patients. The FTO rs9939609 and PPARy rs1801282 polymorphisms were determined by~     real-time PCR.~   "
52021|NCT02885987|"~     The purpose of this investigator-initiated study is to determine whether the use of an~     accessory device called AmplifEYE can improve colonoscopy quality in patients who are~     undergoing average risk colorectal cancer screening. Primary end point is adenoma detection~     rates.~   "
52022|NCT02885974|"~     The purpose of this study is to compare patient tumor tissue before and after treatment with~     chemotherapy plus celecoxib. Investigators will look at gene expression, to see what effect~     celecoxib may have on tumor cells.~   "
52023|NCT02885961|"~     The pathogenesis of idiopathic pulmonary fibrosis (IPF) is incompletely understood but~     recurrent epithelial injury occurs which evokes the coagulation cascade. Thrombin is produced~     as a result and is over expressed in IPF patients, so may be important in propagating disease~     activity. We aim to recruit patients with IPF and then complete FDG~     (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose) PET (positron emission tomography) scans~     pre and post manipulation of the coagulation cascade to assess the role of this biological~     pathway in disease activity. Previous studies from our institution have demonstrated~     increased FDG avidity in the lungs of patients with IPF (assessed using FDG PET scans) but to~     date the cells and pathways responsible for this signal have not been identified and thus~     need further exploration.~   "
52024|NCT02885948|"~     This is an investigator led, randomised, double blind, placebo controlled, double arm~     comparator study.~   "
52025|NCT02885935|"~     The investigators examined the effects of 4-week dietary protein intake in mixed meals at two~     levels of protein amount on whole body glucose metabolisms in older adults with metabolic~     syndrome.~   "
52026|NCT02885922|"~     Recently, there are some new classes of anti-diabetic drugs availible in Taiwan. In this~     study, we will observe the change in inflammation and energy homeostasis in type 2 diabetic~     outpatient, who receiving a new anti-diabetic drugs.~   "
52027|NCT02885909|"~     This study will be conducted in the ward of Taichung Veterans General Hospital. The patient~     with hyperglycemia in hospitalization will be enrolled by glucose management team.~   "
52028|NCT02885896|"~     In order to show that tailored pediatric counselling by telephone can reduce the number of~     unscheduled and medically unjustified physicians visits in emergency structures, a randomized~     controlled study is conducted. It compares the proportion of cases which used the emergency~     services or unscheduled consultation according to whether they received (or not) nurses'~     telephone advices from the platform. Indeed, our hypothesis is that the presence of nurses~     responding at the Reception and Control Calls Center inside the Emergency Medical Services~     (in french : Service d'Aide Médicale d'Urgence SAMU) - whose role is to deliver appropriate~     advice to people calling for benign pathologies they see as urgent and to answer questions~     following specific recommendations - will reduce the number of unplanned and medically~     unjustified consultations in medical emergency structures.~      This platform was set-up in order to show it may be a solution in response to the growing~     demand for pediatric care from the population, helping to reduce overcrowding in emergency~     care facilities. Indeed, promoting home care or only if necessary scheduled consultation~     reinforces the conduct to have when facing a pathology from their child. It will also help by~     reducing unjustified use of emergency structures, improving not only the users' reception~     conditions who actually require support in these structures with less waiting time, but also~     the working conditions for employees who perform there.~   "
52029|NCT02885883|"~     Three groups of patients will be considered: a control group (n = 10); a group of patients~     with paroxysmal or persistent AF with AF cryoablation procedure - within this group, MRI will~     replace CT-scan usually performed in routine before the procedure (n = 15); a group of~     patients with permanent AF (n = 15). MRI study will include pulmonary veins angiography with~     gadolinium injection (0.20 mmol/kg), 2D-cine imaging and late-enhancement imaging. A 3D~     gradient-echo sequence(Flash 3-D) will then be applied 20 minutes after the injection, with~     the following parameters : echo time 0.98 ms, repetition time 2.53 ms, angle 15°, resolution~     2.0x1.3x1.0 mm. T1 map and two T2 sequences will be performed so as to determine LA~     relaxation times. Argus software will be used for post-treatment imaging. Quantitative data~     will be expressed in mean ± SD. A comparison of T1 and T2 values in LA will be performed~     between the three groups. Statistics will be performed with SPSS software in bilateral~     analysis and a value of p < 0.05 will be considered as significant.~   "
52030|NCT02885870|"~     The spinal cord is a common site for the development of several neurodegenerative~     neurological disorders (spinal muscular atrophy or SMA, amyotrophic lateral sclerosis or ALS,~     X-linked spinal bulbar muscular atrophy or SBMA). In different proportions, these diseases~     involve axonal loss in large funiculi of the spinal white matter, their demyelination, and~     loss of ventral horn motor neurons or motoneurones of the spinal gray matter. The lack of~     specific biomarkers of these macro and microscopic spinal damages, makes it difficult the~     differential diagnosis and monitoring of these diseases.~      Techniques to explore non-invasively the human central nervous system, such as magnetic~     resonance imaging (MRI) and electrophysiology, are potential tools to extract specific~     biomarkers of spinal damages. However, imaging techniques are still poorly developed at~     spinal level for technical (specific antennas), anatomical (size of the spinal cord,~     vertebrae) and physiological reasons (cardio-respiratory movements). However, recent advances~     in the field of spinal cord imaging allowed to extract quantitative data on neuron loss,~     axonal degeneration and demyelination in different spinal pathologies whether degenerative~     (ALS or SMA) or traumatic (SCI). Correlations were found with clinical data, and in ALS~     patients, the changes in MRI metrics over time paralleled the functional deterioration. The~     electrophysiological techniques are used since a long time, leading to a good knowledge of~     the neurophysiology of human spinal cord. In addition, electrophysiology indirectly provides~     data at a microscopic scale, providing information on the excitability of spinal neural~     networks and giving an estimate of the amount of functional neurons.~      By combining these techniques for the investigation of human spinal cord in vivo, the goal is~     to extract new biomarkers using as study models, diseases of the spinal cord affecting~     differentially the white and the gray matter (SMA, SBMA and ALS).~      At first, new methods of diffusion MRI and modelling will be performed in healthy subjects to~     assess the axonal density and diameter of the fibers in the white matter. The anatomical~     imaging T2 will measure the geometrical parameters of the spinal cord such as its surface~     and/or volume at a given vertebral level. Thanks to imaging, we will construct via methods of~     segmentation and image processing, an atlas of the spinal cord that will allow to locate~     spatially spinal atrophy in patients. After this phase of validation, A study of patients~     will be conducted using these new MRI techniques, in addition to those already developed in~     the laboratory. The contribution of electrophysiology will be to assess more accurately the~     microscopic damage. Quantitative data from imaging and electrophysiology will be correlated~     with clinical data in order to extract the most relevant biomarkers.~      This project has thus a methodological interest by proposing the development of new methods~     to assess the human spinal cord, at both macro and microscopic levels. These methods are~     based on the development of the techniques developed at spinal level and which are already~     applicable to human pathologies. The original combination of imaging and electrophysiology~     will also enable us to further analyze the human spinal cord, both anatomically and~     functionally. This project has an important clinical value for the extraction of biomarkers~     in diseases where there is an unmet need for diagnosis, monitoring, prognosis and evaluation~     of new therapies.~   "
52031|NCT02885857|"~     Safety and efficacy of long-term application of Shenyankangfu Tablets in Large sample of~     patients with chronic kidney disease.~   "
52042|NCT02885714|"~     Rotator cuff tear is a very common and disabling condition that can be related to acute~     trauma such as falling on the shoulder. A tear is associated with symptoms such as pain in~     abduction, abduction weakness and night pain. Rotator cuff tear surgery is a well-established~     form of treatment in acute rotator cuff tears, although beneficial results have been reported~     for both conservative and surgical treatment of rotator cuff tears. Rotator cuff tear repair~     surgery involves a considerable amount of re-ruptures, and it is possible that the repaired~     tendon do not heal despite surgical repair. On the other hand rotator cuff tears are also~     found in completely asymptomatic persons and the clinical significance of a rupture may be~     generally lower than estimated. The above-mentioned factors, as well as recent research and~     meta-analysis on the treatment of mainly degenerative rotator cuff tears indicate that there~     is a limited evidence that surgery is not more effective in treating symptomatic rotator cuff~     tear than conservative treatment alone. However, these previous research findings cannot be~     applied directly to traumatic tears, although degeneration can be considered always to~     contribute to the creation of a rotator cuff tear.~      During few last decades, despite the lack of evidence on the superiority of one treatment~     over another, the use of surgery to treat this disorder has been substantially increased.~     Treatment expectations are found to be important in predicting patient related outcome~     measures. In addition, surgery itself may produce a profound placebo effect. There are no~     previous placebo-controlled trials on the topic of interest. In order to find out the true~     efficacy of surgical treatment of acute, trauma related rotator cuff tears involving mainly~     the supraspinatus tendon, the investigators have designed this multi-centre, randomized,~     placebo-controlled efficacy trial.~   "
52699|NCT02877160|"~     This study is a single-center, randomized, open-label crossover study to assess the~     pharmacokinetics and food effect of AL-794 formulations in healthy subjects.~   "
52032|NCT02885844|"~     Parabolic flight is the only ground-based condition in which weightlessness (0G) can be~     created long enough for safely testing changes in human perception and behavior. In addition~     to the 0G period, parabolic flight generates equal duration periods of 1.8G, which present~     another unique opportunity to test the same responses to hypergravity and back to 1G.~      Spatial orientation perception is a critical subsystem that is used by the central nervous~     system in the control of vehicles and other complex systems in a high-level integrative~     function. Evidence from space flight research demonstrates that spatial orientation is~     altered by the transitions in gravito-inertial force levels (Clément 2011; Clément & Reschke~     2008), transitions corresponding to mission phases particularly critical for crew safety and~     mission success. Accurate perception of self-in-space motion and self-motion relative to~     other objects is critical for successful operations that involve motor control e.g. doing an~     extra-vehicule activity or piloting the spacecraft. To date, there is only limited~     operational evidence that these alterations cause functional impacts on mission-critical~     operations and control capabilities. Immediately after space flight, most crewmembers have~     reported some degree of disorientation/perceptual illusion, often accompanied by nausea (or~     other symptoms of motion sickness), and frequently manifested by lack of coordination,~     particularly during locomotion The hypothesis is that alteration in sensorimotor performance~     induced by inverted vision is gravity depend: maximum alteration during hypergravity,~     intermediary alteration during normal gravity, minimal alteration during weightlessness.~   "
52033|NCT02885831|"~     The aim of this study is to prove the improvement of pubo-femoral distance by early abduction~     splintage in one-month-old infants with developmental dysplasia of the hip (with a clinical~     stable hip but an abnormal hip ultrasonography).~   "
52034|NCT02885818|"~     Abatacept disrupts T-cell coactivation signals in rheumatoid arthritis (RA). Its potential~     effects on B cells are not well described. This study will assess the effects of abatacept~     therapy on the phenotype and function of peripheral blood B cells in patients with RA.~   "
52035|NCT02885805|"~     Evaluation of the effectiveness of a sunscreen product by determining its Sun Protection~     Factor (SPF) on the skin of human subjects.~   "
52036|NCT02885792|"~     Schizophrenia is a severe mental illness associated with excess mortality and affecting~     nearly 1% of the population. The average life expectancy for patients diagnosed with~     schizophrenia has been 55-60 years through the last generations in Denmark, while the general~     population has over the same period of time experienced an increase in life expectancy. As a~     result, the standardized mortality rate for patients with schizophrenia has increased~     markedly over the last three decades and is currently a major public health concern. Causes~     of death are mainly cardiovascular disease and patients diagnosed with schizophrenia has a~     relative risk of cardiovascular disease that is about 2-fold higher than the general~     population.~   "
52037|NCT02885779|"~     The advantages of the celioscopy mini--trocar and monotrocar technical are recognized.~      There is however no forward-looking or retrospective study comparing the~     microcomputed-celioscopy (use of microphone) - trocar of 3mm of diameter in access~     celioscopic pluri--trocar) in the celioscopy monotrocar ( a single intra-umbilical section)~     in gynecological surgery.~      The objective of this preliminary study is to compare both surgical care in terms of~     morbidity died operating, in adnexa surgeries.~   "
52038|NCT02885766|"~     A multicenter, open label cohort Phase 1 dose finding study to evaluate tolerability, safety,~     pharmacokinetics and preliminary efficacy of PF-114 for oral administration in adult patients~     with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML), which is~     resistant to the 2-nd generation Bcr-Abl inhibitors or has T315I mutation in the BCR-ABL~     gene.~   "
52039|NCT02885753|"~     Colorectal cancer is the 3rd most common cancer in France and the 2nd cause of death from~     cancer. Between 30 to 60% of patients develop limited or predominant liver metastases.~     Surgical resection of these metastases, only curative treatment is not immediately possible~     in 10-15% of cases. In unresectable patients, current palliative treatments are based on~     systemic chemotherapy associated or not with the targeted therapies (anti-EGFR (panitumumab),~     anti-VEGF (bevacizumab)). In this patient population, special attention was paid to~     intensified treatment regimens in order to improve their efficiency and improving the tumoral~     response rate, the intensity of the response and its earliness correlate with improved~     overall and progression-free survival.~      The intra-arterial use of oxaliplatin coupled with IV chemotherapy has yielded OR levels of~     64% in patients having survived one or more lines of chemotherapy IV and 62% in patients who~     have progressed on oxaliplatin IV. In addition, the HIA administration of oxaliplatin limits~     systemic and especially neurological toxicities, thanks to a greater hepatic clearance.~      In conclusion, the combination of systemic chemotherapy, targeted therapy and HIAC with~     oxaliplatin has showed promising efficacy results associated with good tolerance from the~     first line onwards. Indeed, we can expect from the Phase II recent data, a control rate close~     to 100%, with high response rates associated with early maturity and depth responses as well~     as prolonged survival. However, to date, in the absence of randomized trial testing this~     combination, this strategy does not have sufficient evidence to be integrated in our routine~     practices, and HIAC remains limited to a few expert centers in treatment catch-up.~   "
52040|NCT02885740|"~     The purpose of this study is to analyze the association of atrial fibrillation onset in~     normal heart and:~        -  Genetic determinants (genes of receptors, enzymes involved in synthesis and degradation,~          genes of bioavailability of coenzymes and nutritional precursors)~        -  Metabolic determinants of adenosine and methionine cycles~        -  Nutritional determinants.~      Secondary purposes are:~        -  Analysis of physiopathologic mechanisms of AF in normal hearts and adenosine metabolisms~          and its interaction with methionine metabolism, according to identified genetic~          determinants~        -  Analysis of blood markers of adenosine and methionine metabolites as phenotypic markers~          of detected polymorphisms~        -  Evaluate the role of adenosine receptors in AF onset~   "
52041|NCT02885727|"~     Research Hypothesis: The combination of ionizing radiation and immunotherapy (durvalumab) is~     well tolerated and stimulates a clinically significant pancreas-cancer specific immune~     response.~      The primary objective will be to evaluate whether the combination of RT and durvalumab can~     improve median PFS compared to chemotherapy historical control data in metastatic pancreas~     cancer patients who have progressed through first-line chemotherapy.~      The primary intent of RT in this study is to augment a pancreatic cancer-specific immune~     response when given with durvalumab.~   "
52048|NCT02885636|"~     The enormous and rapidly growing burden of Heart Failure with Preserved Ejection Fraction~     (HFpEF) has led to a need to understand the pathogenesis and treatment options for this~     morbid disease. Recent research from the investigator's group and others have shown that~     pulmonary hypertension (PH) is highly prevalent in HFpEF, and right ventricular (RV)~     dysfunction is present in both early and advanced stages of HFpEF.~      These abnormalities in the RV and pulmonary vasculature are coupled with limitations in~     pulmonary vasodilation during exercise. There are no therapies directly targeted at the~     pulmonary vasculature that have been clearly shown to be effective in HFpEF. A recent study~     by Mayo Clinic Investigators has demonstrated pulmonary vasodilation with dobutamine (a beta~     2 agonist) in HFpEF. As an intravenous therapy, this is not feasible for outpatient use.~      In the proposed randomized, placebo-controlled double blinded trial, the investigators seek~     to evaluate whether the commonly used inhaled bronchodilator albuterol (a beta 2 agonist),~     administered through a high-efficiency nebulizer device that achieves true alveolar drug~     delivery, improves pulmonary vascular resistance (PVR) at rest and during exercise in~     patients with HFpEF as compared to placebo. This has the potential to lead to a simple cost~     effective intervention to improve symptoms in HFpEF, and potentially be tested in other World~     Health Organization (WHO) Pulmonary Hypertension groups. PVR is an excellent surrogate marker~     for pulmonary vasodilation and has been used in previous early trials of PH therapy.~   "
52049|NCT02885623|"~     This study evaluates the clinical significance of CX3CR1-expressing myeloid and lymphoid~     cells in patients of hematologic malignancy.~      Tumor cells either express membrane molecules or release tumor-derived soluble factors able~     to alter myelopoiesis and lymphopoiesis. Myeloid cells expressing CD11b play a critical role~     in sustaining cancer progression. Also, the fractalkine (CX3CL1; Fkn)/CX3CR1 axis plays an~     important function in the pathophysiology of various forms of cancers. Fkn is the only known~     ligand for CX3CR1, and it triggers recruitment of CX3CR1-positive cells through its unique~     receptor, CX3CR1. Therefore, the investigators focused the prognostic significance of CD11b+~     myelo-monocytic cells expressing CX3CR1 and CD3+ lymphoid cells expressing CX3CR1 in the~     clinical outcomes of newly diagnosed Diffuse Large B-cell Lymphoma (DLBCL) and Multiple~     myeloma (MM).~   "
52050|NCT02885610|"~     The purpose of this study is to initially access the safety and effectivity of RC18 combined~     with standard treatment and Placebo combined with standard therapy in subjects with Moderate~     to severe SLE, Besides ,to provide dose basis for follow-up clinical trials.~   "
52051|NCT02885597|"~     The purpose of this study is to determine whether Juanbi Pill combined with methotrexate are~     effective in the treatment of active Rheumatoid Arthritis (RA).~   "
52052|NCT02885584|"~     High frequency percussive ventilation (HFPV) is a high frequency ventilation mode in which~     high frequency pulses accumulate to generate a low frequency tidal volume at a controlled~     airway pressure. Previous studies have suggested a protective effect of HFPV on lung injury.~     The goal of our study is to compare, in early ARDS patients, the effects of conventional~     mechanical ventilation and of high frequency percussive ventilation on alveolar recruitment~     and distension evaluated by CT-scan~   "
52053|NCT02885571|"~     This study evaluates whether objective compliance monitoring can increase mandibular~     advancement device (MAD) usage in obstructive sleep apnea (OSA) patients. Half of~     participants will be assigned to objective compliance monitoring group (experimental group),~     while the other will be assigned to subjective compliance monitoring group (control group). A~     physician will prescribe and explain to patients based on data from objective or subjective~     compliance monitoring.~   "
52054|NCT02885558|"~     The purpose of this study is to examine the role of T-type calcium channels in endothelial~     dysfunction observed with ageing.~   "
52055|NCT02885545|"~     Patients with severe chronic kidney disease (CKD) who develop atrial fibrillation are at high~     risk for stroke. The use of blood thinking medication in dialysis patients is controversial~     and warfarin carries a serious risk for major bleeding.~      The Watchman device may be an ideal therapy for this population as after implantation it~     allows for the discontinuation of blood thinners, thereby reducing the risk of bleeding.~   "
52056|NCT02885532|"~     The ability to meaningfully consent intoxicated and chemically dependent patients for~     research has inhibited medical advances in this vulnerable population. A recent pilot~     supported use of the University of California, San Diego Brief Assessment of Capacity to~     Consent tool to assess the capacity of intoxicated emergency department patients to~     participate in research. The objective is to determine the number of intoxicated emergency~     department patients who could correctly complete the questionnaire, and evaluate alcohol~     concentration, sedation and ability to recall participation upon sobriety.~   "
52057|NCT02885519|"~     The purpose of this study is to investigate the efficacy of 1) a stepped mental health care~     (MHC) intervention and 2) an integrated mental health care and vocational rehabilitation (VR)~     intervention for people on sick leave because of burnout, adjustment disorder and~     psychological stress in Denmark~   "
52058|NCT02885506|"~     The First in Human (FIH) study is separated into two parts:~        -  The first part is a Single Ascending Dose (SAD), double-blinded, randomized and~          placebo-controlled, including 8 cohorts of 8 subjects (2 placebo and 6 on active drug).~        -  The second part is a food effect cohort with an open-labelled, randomized fed/fasted~          cross-over design.~      The main objectives of the study are to confirm safety, tolerability and Pharmacokinetics~     (PK) of P218 in healthy volunteers.~   "
52059|NCT02885493|"~     The strong relationship between falling and severity of cognitive impairment in the elderly~     is well established. The association premorbid gait and executive disorders suggests that~     they are under tension by the same mechanisms. The gait fortiori neurological are fall risk~     factors. Dysfunctions underlying disorders as Parkinson called march executive disorders are~     subcortical origin involving so the basal ganglia. This study is indeed based on the~     assumption that the dysfunction of the basal ganglia as observed in parkinsonian syndromes~     resulting in disorders of posture and walking, by dysexecutive syndrome, anxiety and the~     contrast vision disorders. These gait exposed to falls and dysexecutive these disorders with~     cognitive impairment and greater susceptibility to confusional states. The executive~     disorders, gait disorders, anxiety, disturbances of vision and especially saccadic eye~     movements, impaired vision contrasts are well established in the degenerative parkinsonian~     syndromes. This study proposes a new approach to assessing gait disorders to define a high~     risk of falling in the presence of parkinsonian walking in the elderly over 75 years.~   "
52064|NCT02885428|"~     The pathophysiological features of myocardial diabetic subject combined with cardiac~     autonomic neuropathy were behind the quietness of myocardial ischemia, known as silent~     myocardial ischemia (IMS). These patients have the risk to remain asymptomatic until the~     sudden onset of a myocardial infarction, or even sudden death.~      That is why the investigators want to evaluate the contribution of non-invasive tools to~     stand in the diagnosis of IMS patients with diabetes type 2, asymptomatic heart on map:~     Technical myocardial speckle tracking in studying strains overall average left ventricular~     (longitudinal, circumferential and radial) measured in 2D and 3D at rest, compared to stress~     echocardiography with dobutamine (ESD)~   "
52065|NCT02885415|"~     the troponin level and ECGs pre and post operative will be used to determined prevalence of~     myocardial injury among patients undergoing gastrointestinal surgery~   "
52066|NCT02885402|"~     Osteoarthritis is a degenerative disease of hyaline cartilage not associated with an~     infection or an inflammatory process that affects millions of people. The first symptoms~     usually appear from 40-50 years and at this point, conventional radiological tests provide~     diagnostic elements relatively late, poorly correlated with pain relief and providing no~     functional information. In this context, there is a real need for imaging techniques for~     early detection of osteoarthritic changes in a still reversible stage for faster support and~     MRI appears to be the tool of choice.~      Conventional proton MRI sequences already allow improved detection possibilities compared to~     conventional radiology and CT arthrography supplanted. They nevertheless remain insufficient~     to identify incipient lesions or paradoxically to the point of too advanced lesions. Due to~     recent technological advances, exploration MRI other nuclei such as sodium is now possible.~     Quantitation of sodium in the cartilage by sodium MRI allow quantifying proteoglycan loss and~     ultimately a gradation osteoarthritic reached.~      This project's main objective is to quantify the biochemical changes (sodium content)~     occurring at different stages of osteoarthritis defined by clinical algofunctional scores~     (Lequesne) and conventional radiographic scores (Kellgren and Lawrence).~   "
52067|NCT02885389|"~     Infantile Spasms syndrome (ISs) is a characterized by epileptic spasms occurring in clusters~     with an onset in the first year of life. West syndrome represents a subset of ISs that~     associates spasms in clusters, a hypsarrhythmia EEG pattern and a developmental arrest or~     regression. Aetiology of ISs is widely heterogeneous including many genetic causes. Many~     patients, however, remain without etiological diagnosis, which is critical for prognostic~     purpose and genetic counselling. In the present study, the investigators performed genetic~     screening of 73 patients with different types of ISs by array-CGH and molecular analysis of 5~     genes: CDKL5, STXBP1, KCNQ2, and GRIN2A, whose mutations cause different types of epileptic~     encephalopathies, including ISs, as well as MAGI2, which was suggested to be related to a~     subset of ISs.~   "
52068|NCT02885376|"~     The primary objective of this study is to determine the efficacy of Dentoxol® mouthrinse in~     reducing the severity of oral mucositis secondary to radiation therapy for head and neck~     cancer.~   "
52069|NCT02885363|"~     The main objective of this study is to clarify prospectively prognosis of patients newly~     diagnosed as carriers of a LVNC (incident cases) (i.e. without the occurrence of a survival~     of the following events: death, heart transplantation or hospitalization for cardiovascular~     complications). In a second time, prognosis factors will be identify in these patients with~     LVNC.~   "
52070|NCT02885350|"~     In this study the analgesic effect of two different opioids (fentanyl and sufentanil) will be~     compared when given either intrathecally or epidurally in primiparous parturients during~     early phase of the labour.~   "
52071|NCT02885337|"~     Osteoarthritis leads to reduced independence and quality of life. Total hip and knee~     replacement is a successful and cost-effective surgical intervention to relieve pain and~     improve functioning in patients with osteoarthritis. Research has shown that pre-operative~     health status strongly predicts outcomes including physical function and hospitalization~     length after hip or knee replacement surgery. Frail patients, in particular, are at greater~     risk of poor post-operative outcomes and could potentially benefit from interventions~     targeting an improvement in their health status prior to undergoing a hip or knee replacement~     surgery. Partnering with Young Men's Christian Association (YMCA) and a multi-disciplinary~     team of healthcare providers, this pilot trial will examine the feasibility of a multi-modal~     intervention for frail patients that includes a supervised exercise program, vitamin D and~     protein supplementation, and a medication review. The results of this feasibility study will~     guide the design of a future multi-center study, which if successful, could be developed into~     a routine model of care that is implemented in joint replacement programs across Ontario and~     ultimately improving the lives of frail seniors undergoing hip or knee replacement.~   "
52072|NCT02885324|"~     This pilot will study the feasibility and exploratory efficacy of using Cabozantinib for~     recurrent or refractory high grade glioma for which there are no curative options. Patients~     will also be followed for safety, time to progression, event free survival and overall~     survival~   "
52073|NCT02885311|"~     The purpose of this research study is to develop and test a care model to treat excessive~     drinking and alcohol use disorders in the primary care setting. The goal of this research~     study is to increase the identification and treatment of problem drinking in the primary care~     setting. Individuals will be asked to participate in this study because routine screening and~     assessment conducted at your primary care clinic indicates that you have recently exceeded~     healthy drinking limits as outlined by the National Institutes of Alcohol and Alcoholism.~   "
52074|NCT02885298|"~     Endotracheal intubation is most commonly taught and performed with the patient supine. Recent~     literature suggests that elevating the patient's head to a more upright position may decrease~     peri-intubation complications. However, there is little data on success rates of upright~     intubation in the emergency department. The goal of this study was to measure the association~     of head positioning with intubation success rates among emergency medicine residents.~   "
52075|NCT02885285|"~     The purpose of the study is to learn about the impact of exercise on fatigue, anxiety, and~     depression in Parkinson's disease. It is well established that exercise improves the motor~     symptoms of Parkinson's disease. However, it is not clear which types of exercise are most~     beneficial for specific non-motor symptoms.~   "
52076|NCT02885272|"~     The goal of this clinical research study is to compare the results during different scanning~     time points after a contrast drug is given for a FDG PET/CT. The contrast drug helps the~     researchers see the images more clearly.~   "
52081|NCT02885207|"~     The knowledge of encephalitis associated with antibodies targeting intracellular antigens,~     and neuronal surface antibody syndromes has expanded considerably in recent times.~      The primary purpose of the investigators protocole is to determine the incidence of~     anti-neuronal antibodies (blood and CSF) in a population of patients suffering from focal~     epilepsy of unknown cause to guide the management of these patients.~      The investigators hypothesis is that dysimmune encephalitis is more common than is suggested~     by the current literature, and that sometimes forms of encephalitis dysimmune at minimum~     can be observed only in the form of focal epilepsy without further manifestation associated.~   "
52082|NCT02885194|"~     Pain is a common symptom of Parkinson's disease (PD) but the physiology remains poorly~     understood. Recent work suggests that subthalamic nucleus deep brain stimulation (STN-DBS)~     could make a profit on the pain in PD.~      The investigator would drive a study with a follow up of PD patients before and after~     STN-DBS. The pain will be clinically explored by targeted questionnaires and~     electrophysiological through laser evoked potentials.~      The questionnaires are designed to quantify and characterize the pain in these patients.~     Laser evoked potentials will, through repetitive stimulation, study both the functional~     status of the afferent nociceptive pathways, their habituation to repetitive nociceptive~     stimuli, and so better understand any abnormalities of the central processing of nociceptive~     information.~   "
52083|NCT02885181|"~     The primary objective of this study is to evaluate the effect of GS-9876 versus placebo for~     the treatment of signs and symptoms of rheumatoid arthritis (RA) in participants with active~     RA despite methotrexate (MTX) therapy who had an inadequate response to MTX (either alone or~     in combination with biological disease modifying anti-rheumatic drugs [bDMARDs]).~   "
52084|NCT02885168|"~     The purpose is to demonstrate that vasoreactivity of patients with septic shock evaluated~     with dose-response curve is diminished in septic shock and ameliorated by activated protein C~     (APC).~      This amelioration is correlated to decrease of inflammation, decrease of reactive oxygen~     species (ROS) markers and increase of circulating catecholamines.~   "
52085|NCT02885155|"~     The purpose of this study is to determine the prognostic value of echocardiographic~     parameters in comparison with clinical and hemodynamic parameters in pulmonary arterial~     hypertension (PAH).~      A secondary purpose of this study is to analyze the disease evolution after 3 to 6 months. In~     pulmonary fibrosis it has been demonstrated that the variation of clinical and paraclinical~     parameters between 2 examinations has a prognostic interest. In this study the prognostic~     value of variation of some echocardiographic parameters between initial examination and~     echocardiography after 3 or 6 months will be evaluated.~      Another secondary purpose is to create a common database for Pneumology, Cardiology and~     Epidemiology departments with prospective registration of new cases of PAH and follow of~     patients under treatment.~   "
52086|NCT02885142|"~     Local excision for early rectal cancer has proven its feasibility and oncological safety.~     Indeed, lymph node invasion does not exceed 1% and 10% in pT1sm1 and pT1sm2 rectal carcinomas~     respectively. Two procedures are currently performed in these early cancers as well as in~     preneoplastic lesions. Transanal endoscopic microsurgery (TEM), which has proven its~     superiority over traditional transanal excision, is a surgical approach associated with a 92%~     R0 excision rate, a survival comparable to radical anterior resection and a low morbidity. It~     consists of a full-thickness excision. The second procedure is a recently introduced~     technique: the endoscopic submucosal dissection (ESD), which encompasses only the mucosa and~     submucosa. ESD enables endoscopists to achieve higher en bloc resection rates than standard~     mucosectomy and is associated with a 88% R0 resection rate, which decreases to 65% in the~     subgroup of European series. Though very promising, the role of ESD remains controversial in~     malignant lesions with few published reports. There are therefore 2 different techniques with~     2 different dissections (full-thickness vs. submucosal) to achieve the same oncological~     treatment. So far, only one retrospective single-center study including 63 patients has~     compared TEM and ESD in early rectal cancer without finding any difference between the 2~     procedures, and there are no other available studies comparing TEM and ESD for any type of~     colorectal tumor. The aim of the present research is to compare ESD with TEM for early rectal~     cancer and rectal adenomas for short- and long-term outcomes.~   "
52087|NCT02885129|"~     The main objective is to assess the measurement characteristics (validity, reproducibility)~     and the invariance of EGOMAC scale in a population of consultants in diabetology, cardiology~     and rheumatology hospital and liberal and hospital oncology and Infectious disease, by~     following the evolution of patient compliance at D0 and D15.~      The second objective is to assess the sensitivity to change of scale EGOMAC following~     developments compliance 3 months.~   "
52088|NCT02885116|"~     In this study effect of NHF on pulmonary thermodynamic parameters will studied.~   "
52089|NCT02885103|"~     This study will prove to concept of effectiveness of NHF in combination with a nebulizer on~     reversibility of lung function in COPD patients.~   "
52090|NCT02885090|"~     Rett syndrome (RTT) is a genetic encephalopathy and the typical form is caused by mutations~     in the gene MECP2. It is a genetically heterogeneous pathology. CDKL5 and FOXG1 have been~     recently discovered being involved in other forms of RTT. However, at least 5% of typical~     forms and more other atypical forms are not linked to any of 3 genes known to be involved in~     the disease.~      The purpose of this study is to identify new genes involved in molecular etiology of typical~     and atypical forms of RTT.~   "
52102|NCT02884934|"~     Beyond the first 6 months of anticoagulation, patients with a first episode of unprovoked~     venous thromboembolism have a high risk of recurrence after stopping anticoagulations.~     Extending anticoagulant therapy for an additional 18 months is associated with a major~     reduction of recurrent VTE; however this benefit tended to be lost after stopping~     anticoagulation during a follow-up period of two years. This risk of recurrentce is likely to~     continuously increase over the years as well as the risk of chronic thromboembolic pulmonary~     hypertension (after pulmonary embolism) or the risk of post-thrombotic syndrome (after deep~     vein thrombosis). The aim of the PADIS-EXTENSION trial is to estimate these risks over 6~     years of follow-up in patients who have been initially treated during 6 months or 24 months~     (patients included in the PADIS PE and PADIS DVT trial).~   "
53303|NCT02869243|"~     The purpose of the study is to evaluate the feasibility and safety of intra-tumor and~     interstitial therapy with hBMP4 in increasing doses in patients with progressive and/or~     multiple recurrent Glioblastoma multiforme (GBM).~   "
52091|NCT02885077|"~     Even with the advances in clinical therapy and percutaneous interventions, coronary artery~     bypass grafting (CABG) is still widely used in the treatment of patients with coronary artery~     disease (CAD). However, it is a complex procedure that triggers important organic~     implications especially on pulmonary function. In relation to the treatment of patients~     undergoing CABG, the recovery is linked to the cardiac rehabilitation programs. These~     programs can also be associated with other muscle training measures, among these there is~     inspiratory muscle training (IMT). Most studies has been implemented moderate-intensity IMT~     daily, but there are few studies about the effects of high intensity training loads performed~     on alternate days. In this context, is justified the use of a device such as the recent~     Powerbreathe, which uses higher training loads that would provide greatest benefits, whereas~     the magnitude of the response to training tends to increase with load.~      OBJECTIVE: To investigate the efficiency of high intensity IMT associated with combined~     aerobic and resistance training on maximal exercise capacity, submaximal exercise capacity,~     respiratory muscle strenght, pulmonary function, oxidative stress, quality of life and~     endothelial function in patients who underwent CABG in phase II cardiac rehabilitation~     program.~      METHODOLOGY: This is a clinical trials, controlled, randomized,double-blind being developed~     in partnership with Cardiology Clinic of Hospital Universitário de Santa Maria (HUSM), Santa~     Maria, RS, Brazil. Patients will undergo the evaluation of pulmonary function and respiratory~     muscle strength (spirometry and digital manovacuometry), as well on the maximal exercise~     capacity (Ergospirometry), submaximal functional capacity (6MWT and 6MST), of quality of live~     (MLHFQ) of Oxidative stress and endothelial function (blood biomarkers). After the evaluation~     will be randomly allocated into two groups: the control group will perform cardiac~     rehabilitation associated with the Sham of IMT, and the experimental group cardiac~     rehabilitation associated with the IMT High-intensity. The intervention will last twelve~     weeks for both groups and after this phase patients will be submitted again to the assessment~     tools.~      EXPECTED RESULTS: The high intensity IMT potentiates the effects of cardiac rehabilitation~     (phase II) after coronary artery bypass surgery patients.~   "
52092|NCT02885064|"~     This study is observational only and is intended to evaluate changes in the makeup and~     function of bacteria naturally present in the mouth during treatment with braces to~     straighten teeth.~   "
52093|NCT02885051|"~     The purpose of this study is to correlate the composite PIPP-R (Premature Infant Pain~     Profile-Revised) scale and the parasympathetic nervous system (heart rate variability).~   "
52094|NCT02885038|"~     Platelet concentrates (PCs) characteristics, such as storage duration, ABO compatibility,~     dose and source, may have an impact on transfusion responses and outcomes. Because of the~     relative scarcity of PCs the selection of a specific PC for issue to the patient remains a~     challenging process. Regulatory agencies do not fully address these characteristics in their~     recommendations for prophylactic transfusions.~      The aim of the study was to analyse the effect of product-related factors in a real life~     setting, in order to determine which ones are the most relevant when selecting PCs for~     patients in prophylactic conditions. Two different endpoints are studied: the corrected count~     increment and the platelet transfusion time intervals.~   "
52095|NCT02885025|"~     Allergic rhinitis is a common illness suffered among US Veterans. There are medications that~     help relieve allergy symptoms, including nasal steroid sprays and antihistamines. Some~     patients have increase symptoms with exposure to their trigger, such as a grasses when~     combined with pollution due to oxidative stress from pollution. In this study, patients with~     allergic rhinitis to grass will be given broccoli sprout extract that contains an antioxidant~     sulforaphane do see if there is beneficial effect in these patients.~   "
52096|NCT02885012|"~     The purpose of this study is to learn more about the safety and effects of switching~     treatments from bosentan (Tracleer) or macientan (Opsumit) to ambrisentan (Letairis) over 24~     weeks in subjects with Connective Tissue Disease associated Pulmonary Arterial Hypertension~     (CTD-PAH).~   "
52097|NCT02884999|"~     This cohort study describes the epidemiology of trauma patients and their management in a~     French academic trauma center. It also aims to determine what recommendations from the~     European trauma guidelines is applied in routine.~   "
52098|NCT02884986|"~     Acute pain is the result of activating nociceptive pathways in both the peripheral and~     central nervous system. The origin of most acute pain from surgical stimulation is the~     mechanical trauma of the local tissue and the subsequent acute inflammatory response.~      No studies have investigated the combined use of anti-inflammatory analgesics with spinal~     anaesthesia/analgesia for pre, intra and postoperative multimodal pain protection in patients~     undergoing day-case IHR. The aim of the investigators study is therefore to assess the~     efficacy of preoperative combined administration of etoricoxib and standard spinal~     anaesthesia in the reduction of postoperative pain following IHR.~   "
52099|NCT02884973|"~     It is estimated that the incidence of congenital heart disease varies between 0.5 and 1% of~     live births, 5,000 new cases per year currently in France These are serious diseases that can~     be life-threatening to more or less short term.~      The advances in surgical techniques in recent years has improved the prognosis of these~     patients in the first months of life.~      The success of surgery is, among other things, conditioned by a support per complex~     operation, involving a multimodal intensive monitoring, and respiratory and hemodynamic~     support techniques.~      These elements of surveillance, NIRS (Near-infrared spectroscopy) allows measurement of~     non-invasive tissue saturation (rSO2) in cerebral and renal oxygen.~      The fundamental principle of NIRS based on an estimate of the percentage proportion of~     cerebral oxy-hemoglobin.~      A light source is emitted by NIRS and through body tissues to the brain where the light will~     be absorbed and refracted depending on the tissue composition in oxy-hemoglobin.~      Refracted light will be analyzed by NIRS which in turn using software will help to determine~     a percentage of oxyhemoglobin.~      Normal values of cerebral NIRS are between 50 and 80%.NIRS can be used according to this~     principle to estimate cerebral tissue oxygenation but also for other tissues such as the~     kidney.~      More than the figure, those are changes NIRS compared to a baseline that will alert us to the~     conditions of tissue oxygenation and allow us to identify hypoxia times.~      Changes in the value of the NIRS depends on 3 criteria: the tissue blood flow, the percentage~     of oxyhemoglobin and deoxyhemoglobin percentage.~   "
52100|NCT02884960|"~     The purpose of this study is to evaluate the safety and effectiveness of Embozene~     Microspheres compared with Embosphere Microspheres for the treatment of symptomatic uterine~     fibroids. A total of 118 patents with symptomatic uterine fibroids will be enrolled at 6~     sites. Symptom severity, health-related quality of life, and the appearance of the fibroids~     will be assessed prior to treatment. Patients will then undergo the uterine fibroid~     embolization procedure with either Embosphere Microspheres or Embozene Microspheres, which~     will be randomly assigned. Clinical outcomes will be assessed 1 month, 3 months, 6 months and~     12 months after the procedure, and imaging outcomes will be obtained 3 months after the~     procedure.~   "
52101|NCT02884947|"~     This aim of this study is to improve the outcomes for patient with gliomas undergoing~     neurosurgery by maximising the extent of resection whilst minimising neurological morbidity.~     This will be achieved through the use of advanced MRI, fMRI and DTI, performed at two stages~     of the patients' clinical management.~   "
52103|NCT02884921|"~     Dental treatment for children should be done in a calm atmosphere and without pain. Oral~     Propacetamol has been shown to be effective in a variety of postsurgical pain models.~      There are no studies on paracetamol preemptive analgesia effect on the pediatric population~     in the dental setting which compare analgesic effect when administered before Vs after the~     dental treatment.~      The investigators hypothesis is that preoperative intravenous paracetamol are helpful in the~     prevention of postoperative pain in children undergoing dental treatment.~   "
52104|NCT02884908|"~     The primary study objective is to determine the efficacy of pregabalin administered orally~     for a period of 12 weeks in reducing risky drinking and symptoms of posttraumatic stress~     disorder who have selected genotypes at the gamma-amino butyric acid transporter and receptor~     genes. The secondary objective is to assess the safety and tolerability of pregabalin in~     participants with alcohol use disorder and co-occurring posttraumatic stress disorder who~     have selected genotypes at the gamma-amino butyric acid transporter and receptor genes. The~     investigators will utilize a large and diverse sample of African-Americans that includes both~     genders and individuals with different types of trauma. All participants will receive~     standardized bi-weekly Brief Behavioral Compliance Enhancement Treatment (BBCET).~   "
52105|NCT02884895|"~     Tracheal intubation is an important part of treatment for a trauma casualty. Tracheal~     intubation is usually achieved by a direct laryngoscope.It is an effective method but~     requires experience and skill demanding a long learning time.The use of the Laryngeal Tube~     Suction for fast control of the airway is known for many years. The Intubating Laryngeal Tube~     Suction is a new version of the Laryngeal Tube. The aim of this study is to examine the~     effectiveness of the the Intubating Laryngeal Tube Suction to achieve a definitive airway by~     unskilled practitioners in anesthetized patients with the head in neutral position (trauma~     model).~   "
52106|NCT02884882|"~     Compare the emotional experience of patients with focal lesions of the basal ganglia by~     ischemic or hemorrhagic damage and healthy participants. These anomalies will be highlighted~     by neuropsychological and electrophysiological assessments.~   "
52107|NCT02884869|"~     Control the airways by endotracheal intubation is an important part of treatment for a trauma~     casualty. The use of the Laryngeal Mask Airway for fast control of the airway is known for~     many years. The aim of this study is to examine the effectiveness of the Intubating Laryngeal~     Mask Airway to achieve a definitive airway by unskilled practitioners.~      The hypothesis is that definitive airway obtaining with Intubating Laryngeal Mask Airway will~     be more success and faster compared to the standard way of direct laryngoscope.~   "
52108|NCT02884856|"~     Visual shade matching (VSM) is the most common procedure to select an adequate shade in~     dentistry. This clinical procedure requires the use of a shade guide, being Vita Classical~     (VC) the most popular among the available guides. VSM is a subjective and inconsistent~     process with many observer related variables (e.g. color deficiency, experience, gender and~     eye fatigue) that can influence on the final color appearance. The gender influence on the~     accuracy of VSM is controversial.~      The purpose of this study is to evaluate the VSM performed by female (F) and male (M)~     students, using VC shade guide, testing the null hypothesis that VSM is not influenced by~     gender.~   "
52109|NCT02884843|"~     The study compares the intubating Laryngeal Tube Suction (iLTS-D) with the Ambu®AuraGain™ in~     blind and fibreoptic endotracheal intubation.~      The current randomized study is designed to assess the success rate of blind and fibreoptic~     endotracheal intubation using i-LTS-D, in comparison with the Air-Q, i-gel® and~     Ambu®AuraGain™ in an airway simulator. The investigators hypothesize that the iLTS-D and the~     Supreme Laryngeal Mask Airway will similarly perform during spontaneous ventilation despite~     differences in their structural design.~   "
52110|NCT02884830|"~     Static hyperinflation is frequent in Chronic obstructive pulmonary disease (COPD) , resulting~     in increased end expiratory lung volume and positive end expiratory pressure (PEEPi) at the~     end of a normal expiration.~      Static hyperinflation worsens the work of breathing is increases patient's dyspnea.~      The application of a continuous positive airway pressure (CPAP) has been shown to improve~     static hyperinflation and to decrease the work of breathing.~      Sleep is deteriorated in COPD patients, and causal factors includes static hyperinflation.~     The purpose of our study is to assess the effect of nocturnal CPAP on sleep quality and~     functional respiratory parameters.~   "
52111|NCT02884817|"~     A commercially available mouth rinse with ethyl lauroyl arginate and essential oils claims to~     have enhanced antimicrobial properties as compared to the traditional essential oil products.~     The aim of the present study was to compare the plaque and gingivitis inhibiting effect of~     the commercial product containing essential oils with ethyl lauroyl arginate with one placebo~     and one negative control in a modified experimental gingivitis model. In three groups of~     healthy volunteers, experimental gingivitis was induced and monitored over 21 days,~     simultaneously treated with the commercial test solution, 21.6% hydro-alcohol solution and~     sterile water respectively. The maxillary right quadrant of each individual received~     mouthwash only, whereas the maxillary left quadrant was subject to both rinsing and~     mechanical oral hygiene. Compliance and side effects were monitored at day 7, 14, and 21.~     Plaque and gingivitis scores were obtained at baseline and at day 21.~   "
52112|NCT02884804|"~     At the entry of the delivery room, a standard blood analysis will be performed (Blood count,~     PT, aPTT, Fibrinogen, and D-Dimer) for each women (if they are agree), according to the~     center's practices.~      The percentage of the immature platelets is a an additional parameter on the hemogram.~      The clinical assessments (recorded in medical records) and biological values will be used to~     determine if there is a correlation between these data and the occurrence of postpartum~     hemorrhage.~   "
52113|NCT02884791|"~     The primary aim of this study is to examine the effect of acute ingestion of fructose on~     serum FGF21 levels. Subjects in this study will be lean volunteers and individuals with~     metabolic syndrome.~   "
52149|NCT02884323|"~     This is a single centre open label study measuring lower limb physiology in patients with~     venous leg ulcers at the University Hospital of South Manchester.~      Ambulatory venous pressure, venous transit times, wound bed tissue oxygenation and changes in~     microcirculation will be measured at baseline after the gekoTM device is activated.~     Ambulatory venous pressure and venous transit times will be performed whilst the participant~     is standing, sitting and supine~   "
60613|NCT02773498|"~     To compare motile sperm extraction rate between microTESE and conventional TESE in 18-50~     years-old men with non obstructive azoospermia.~   "
52114|NCT02884778|"~     Title: Evaluation of the last version of the PMD200TM and its NoL index in patients~     undergoing laparotomies with intraoperative epidural analgesia Objectives: Measure NoL Index~     changes after a standardized nociceptive electrical stimulus at various intravenous~     remifentanil infusion rates (0.005, 0.05, 0.1 mcg/kg/min) and also after clinical stimuli~     such as intubation.~      Study Design: Prospective observational study Subject Population: Adults scheduled to undergo~     elective abdominal surgery with laparotomy under general anesthesia and epidural analgesia~     Sample Size: 30 patients Study Duration: Starts April 2016 - Ends November 2016 Study Center:~     Maisonneuve-Rosemont Hospital, Montreal, Quebec, Canada Adverse Events: None expected~   "
52115|NCT02884765|"~     Prospective data will be collected in approximately 250 patients sustaining BCFx with or~     without any additional fracture(s) of the symphysis. Patients will be followed according to~     the standard (routine) at approximately 6 weeks and 3 months after the treatment. Data~     collection will include fracture details (i.e. classification, mechanism of injury),~     treatment details, functional and patient-reported outcomes, and anticipated or~     procedure-related adverse events (i.e. complications).~   "
52116|NCT02884752|"~     Only 24 cases of Campylobacter bone and joint infection (BJI) have been reported worldwide~     between 1955 and 2008. Between 2010 and 2012, 7 cases were observed in two University~     hospitals in France. This increasing number of cases raises several issues. Are they the~     consequences of better detections and reporting, or are they reflecting any epidemiologic~     changes? For answering these questions, we performed a 10 year (2002-2012) retrospective~     multicenter (6 centers) study on BJI (native and implanted joints) due to Campylobacter~     species.~   "
52117|NCT02884739|"~     As in the general population, there is a gradual and steady increase in life expectancy of~     patients with schizophrenia. But this increase is at a smaller scale, with a rate of~     premature death that is still 2 to 3 times higher than that found in the general population.~     This excessive early mortality is explained by an overrepresentation of suicide deaths, but~     also a higher prevalence of somatic diseases, mainly cardiovascular. But today there are only~     very few epidemiological data on the mortality of patients with schizophrenia, including~     those aged over 60 years. What are the sociodemographic and clinical characteristics~     (psychiatric and somatic) of these schizophrenic elderly patients? Do they benefit from a~     somatic follow-up adequate and systematic? What are their levels of social independence and~     of quality of life? the answers these questions and the description of the offer of geriatric~     care and of psychiatric care currently provided by different sectors of psychiatry in France~     is an indispensable prerequisite for any project to improve the quality of life, state of~     health and mortality of older patients with schizophrenia.~   "
52118|NCT02884726|"~     The purpose of this study is to assess the safety and tolerability of Mesothelin-ADC in~     subjects with advanced and/or metastatic solid tumors.~   "
52119|NCT02884713|"~     Helicobacter pylori (H. pylori) eradication is achieved in 60-80% with first-line therapy.~     Different second-line therapeutic options are available. However, the success of second-line~     therapy has not been addressed or reported from Saudi Arabia.~      Objectives The primary objective was to evaluate the efficacy of the 10-day course of~     levofloxacin, doxycycline and esomeprazole in non-responders to first-line therapies for H.~     pylori eradication in Saudi Arabia. Secondary objectives included; symptoms response to~     treatment, factors associated with eradication of H. pylori and adverse events associated~     with the treatment.~   "
52120|NCT02884700|"~     The study aimed at further describing the epidemiological, clinical, diagnostic and~     prognostic features in legionellosis cases admitted to Grenoble University Hospital during~     the 2006-2011period. The investigators also tested lower respiratory samples collected from~     these patients during their routine medical care, using a number of molecular tools allowing~     determination of the involved Legionella species, the bacterial load, and the presence of~     antibiotic resistant mutants. Our primary goal was to define biological markers that could~     predict severity and outcome of infection in legionellosis cases requiring hospitalization.~   "
52121|NCT02884687|"~     The study focuses on the use of antibiotics in Regional Hospital Center Metz-Thionville~     (CHRMT) between 2007 and 2014. To analyze the strategies and decisions related to the~     appropriate use of antibiotics for this center, some Semi-Directive Interviews (SDI) are~     realized on the study period with all concerned actors of the Good Use of antibiotics. An~     interviewing plan and tree interview guidelines were created. All SDI are processed by the~     same person.~   "
52122|NCT02884674|"~     Evaluate the therapeutic effect of a functional Magnetic Resonance Imaging (fMRI)-guided and~     robotized neuronavigated theta burst Transcranial Magnetic Stimulation (TMS) targeting right~     inferior frontal region in resistant obsessive compulsive disorder (OCD) in a double-blind,~     randomized, placebo-controlled, monocentric study.~   "
52123|NCT02884661|"~     In order to evaluate the implementation for the recommendations about the patient care for~     atrial fibrillation in aged patients, a non-interventional study is performed retrospectively~     by comparing two approach of the focus in Cardiology Department and in Geriatric unit.~   "
52124|NCT02884648|"~     The goal of this clinical research study is to learn if Avastin (bevacizumab) can help to~     control ovarian, fallopian, or primary peritoneal cancer that has been found during~     second-look surgery.~   "
52125|NCT02884635|"~     The objective of this study is to evaluate the efficacy, pharmacokinetics, pharmacodynamics~     and safety of ASP1707 in combination with MTX in postmenopausal female patients with RA.~   "
52126|NCT02884622|"~     Lung disease progression is variable among cystic fibrosis (CF) patients and depends on DNA~     mutations in the CFTR gene, polymorphic variations in disease-modifier genes and~     environmental exposure. The contribution of genetic factors has been extensively~     investigated, whereas the mechanism whereby environmental factors modulate the lung disease~     is unknown. Because these factors can affect the epigenome, investigators hypothesized that~     DNA methylation variations at disease-modifier genes modulate the lung function in CF~     patients.~   "
52127|NCT02884609|"~     The purpose of this study is to evaluate the tolerance and the efficiency of subcutaneous~     administration of Paracetamol for patients in palliative care.~   "
52128|NCT02884596|"~     To evaluate the success of inferior alveolar nerve block (IANB) for mandibular molars with~     irreversible pulpitis in women under treatment with selective serotonin reuptake inhibitors~     (SSRIs).~   "
79115|NCT02531360|"~     The overall goal of this imaging trial is to characterize [18F]MNI-815, a PET radioligand for~     imaging Tau.~   "
52129|NCT02884583|"~     Prevalences of food allergies and asthma increased in the population during the last decades.~     These two pathologies, responsible for a real burden, are often associated and are to be~     considered as comorbidities; this aspect is more and more studied in the literature and many~     authors tried to find a link between diets and asthma. The narrow link between these two~     atopic pathologies and the fact that food allergy can come along with respiratory symptoms~     also in patients without history of asthma must be better understood, considered into the~     management of food allergy. The main objective of this study is to study the prevalence of~     signs and/or symptoms suggestive of bronchial hyperreactivity, during an oral food challenge~     (OFC) in patients older than 5 years. The secondary objective is to study the risk factors to~     develop asthma during a food allergy reaction.~      This historical-prospective single center study , was realized in the Allergy Unit of the~     University Hospital of Montpellier. All the patients having been hospitalized for a positive~     OFC between January, 2001 and January, 2016 were included. The diagnosis of asthma was~     established according to the recommended international clinical and physiological criteria.~     Prevalence of bronchial hyperreactivity during OFC among those with positive OFC, was~     calculated. The search for risk factors was made by a logistic regression univariate then~     multivariate, completed by a decision tree.~   "
52130|NCT02884570|"~     To assess the prevalence of anxiety / depression in post- hospital for parents (mothers and~     fathers) of children with tracheotomy before the age of 1 year between 2000 and 2012.~   "
52131|NCT02884557|"~     Inflammatory bowel diseases (IBD) include Crohn's disease (CD) and ulcerative colitis (UC).~     These diseases are a public health problem because they concern many patients (1 case in~     1000). IBDs are characterized by dysregulated immune response against luminal antigens~     causing chronic inflammation of the gut in genetically predisposed individuals. Their exact~     cause is unknown and there is currently no cure. The primary sclerosing cholangitis (PSC) is~     a liver inflammatory disease of unknown origin that is known to be strongly associated with~     IBD. An important clinical observation highlights the mild symptoms of IBD when associated to~     the PSC. Conversely, treating PSC by liver transplant or immunosuppressive drugs is~     associated with a progression of intestinal inflammation.~      Based, on these clinical findings that suggest a protective effect regulator of liver~     inflammation on intestinal inflammation, and on the results obtained by our group in mouse~     models that identified the natural killer T cell (NKT) as essential in control of~     experimental colitis, the project aims to determine, using PCR, if the expression of NKT cell~     markers are increased in the colon of patients with PSC+IBD compared to patients with IBD~     alone or PSC alone.~   "
52132|NCT02884544|"~     The phase 2 study will evaluate the safety, tolerability and efficacy of HLD100 at steady~     state (following up to 5 weeks of treatment) in children using an outpatient, single-center,~     open-label, flexible dose-escalation study design.~   "
52133|NCT02884531|"~     The incidence of hip osteoarthritis (OA) is rising in western countries due to an ageing~     population and the epidemic of obesity. Patients with hip OA tend to complain of hip pain and~     stiffness which affect alignment and mobility of the whole body and typically result in~     general musculoskeletal pain and disability. Clinical guidelines recommend a combination of~     exercise therapy, weight loss and education, adjusted to the individuals needs, to be tried~     out before arthroplasty eventually is offered. However, to obtain a satisfactory long-term~     outcome is a challenge as patients may not be motivated to comply with a training program~     including functional strength and mobility training, if not guided by a therapist. Basic Body~     Awareness Therapy (BBAT) may be an alternative training modality with a better potential for~     lasting effects. It is a low-impact movement therapy focusing on alignment of the body and~     quality of movements, implemented in daily life activities. In the BBAT learning process by~     doing, reflecting on and transferring body awareness into daily life movements, the~     investigators hypothesize that the patients will obtain self-efficacy and mastering, of~     importance for continued training on their own. This hypothesis will be examined in the~     present randomized controlled trial, comparing Patient Education combined with BBAT and~     Patient Education alone. The investigators will, accordingly, examine the supplementary~     effects of BBAT for patients with hip OA. They will also explore the importance of movement~     quality as observed by physiotherapist using Body Awareness Rating Scale, and how it relates~     to how patients perceive their movement performance. In the study the investigators will~     particularly address long-term effects of the intervention by comparing survival of the~     native hip in the two groups included in the study. Data from the study will be included in a~     national database of patients with non-surgical treatment of hip and knee OA (NOAR), giving~     rise to comparison of different movement therapies.~   "
52134|NCT02884518|"~     The purpose of this study is to determine whether dopamine synthesis capacity by using [18~     fluorine(F)]-DOPA PET for patients with schizophrenia in the maintenance phase can predict~     treatment discontinuation.~   "
52135|NCT02884505|"~     The overall purpose of this study is to employ a pragmatic, multidimensional assessment of~     hypersomnolence that piggybacks on routine clinical care in patients with suspected~     disorders of central nervous system (CNS) hypersomnia, to determine whether these additional~     objective and subjective assessments are useful in the diagnosis and management of these~     patients.~   "
52136|NCT02884492|"~     This study is being done to learn about tau tangles in Alzheimer's disease. A type of PET~     scan is used to measure the abnormal accumulation of protein called tau in the brain. These~     are thought to be involved in Alzheimer's disease. The investigators will also perform brain~     MRI and to tests to measure the participant's memory and thinking.~   "
52137|NCT02884479|"~     The purpose of this study is to test PT-112 in Combination with Docetaxel in Subjects with~     Advanced Solid Tumor in a Phase I Dose Escalation Study and in Subjects with Non-Small Cell~     Lung Cancer.~   "
52138|NCT02884466|"~     Introduction Chronic low back pain (CLBP) is a highly prevalent health condition, and the~     leading cause of years lived with disability. The high prevalence causes a substantial impact~     on patients, communities and health-care systems. There is a continuing challenge to offer~     evidence-based rehabilitation for patients with CLBP. There is a lack of studies on adequate~     follow-up approaches to maintain successful treatment. No earlier study has assessed if the~     positive treatment effects of a multidisciplinary rehabilitation intervention can be~     maintained with an intervention alternating between inpatient interventions and home-based~     activities.~      Aim To assess if a novel multidisciplinary rehabilitation intervention is more effective in~     maintaining successful treatment after 6 months, than a usual multidisciplinary~     rehabilitation intervention in patients with CLBP.~      The novel intervention is a 14-week program alternating between in total three weeks of~     inpatient intervention and home-based activities. This alternation allows the participants~     time and opportunity to adapt and transfer inpatient learning to activities and participation~     in their own environment in interaction with everyday life situations and surroundings. Usual~     care is a four-week inpatient intervention. It is hypothesized that the intervention will be~     superior to usual care.~      Method The study will be conducted at The Danish Rheumatism Associations' rehabilitation~     centre Sano Aarhus. 160 participants with CLBP will be randomly allocated to one of two~     groups. The novel intervention consists of: 1) a pre-admission day, 2) two weeks of~     home-based activities, 3) two-week inpatient period, 4) four weeks of home-based activities,~     5) 1st two-days inpatient follow-up, 6) six weeks of home-based activities and 7) 2nd~     two-days inpatient follow-up. Usual care consists of a four-week inpatient intervention.~      The two groups will be compared according to disability, pain, pain self-efficacy, quality of~     life, depression and exercise capacity.~      Relevance The present study has emerged out of the fields where patients, clinicians and~     researchers intersect and is consequently highly clinically relevant. If positive treatment~     effects can be maintained or even improved in the long term, the results may serve as~     inspiration for the design of multidisciplinary rehabilitation interventions in clinical~     practice; this will be valuable for future patients with CLBP.~   "
52139|NCT02884453|"~     Some cancers of the oesophagus and stomach express excessive copies of either the cMYC~     (Myelocytomatosis oncogene) gene, the HER2 (Human epidermal growth factor receptor 2) gene or~     both. These genes may potentially contribute to the growth and spread of cancer.Ibrutinib is~     a drug that is already used in the treatment of certain cancers of the immune system.~      There is preclinical evidence that it shows activity against gastric and stomach cancer cells~     over-expressing cMYC and HER2 genes.~      The iMYC study will assess the activity of ibrutinib in cancers of the oesophagus and stomach~     which over-express these genes and which have previously been treated with standard~     chemotherapies.~      Any anti-cancer activity seen will be measured and correlated with metabolic changes on FDG~     (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose) - PET (positron emission tomography)~     scan, changes in DNA and circulating tumour cells in the blood, and molecular changes in the~     cancer itself through the use of optional repeat tumour biopsies. If an effect is seen it~     could provide justification for further research in this group of patients.~      Patients will be eligible if they have advanced cancer of the oesophagus or stomach and have~     been treated with at least one line of prior therapy. The study will be conducted at the~     Royal Marsden Hospital at its Sutton and Chelsea sites.~      It will involve an initial group of up to 17 patients. Screening, recruitment and follow up~     will last for 3 years in total.~      Patients wishing to take part must consent to having their cancer biopsied to test for cMYC~     and HER2 amplification, as well as a number of imaging and blood tests. There are optional~     further tumour biopsies whilst on study.~      Patients will be treated with ibrutinib until progression of their disease or unacceptable~     toxicity.~   "
52140|NCT02884440|"~     Therapeutic, prospective, randomized, double blind, placebo-controlled, in intention to~     treat, monocentric study to evaluate the analgesic efficacy of a bilateral TAP block after~     spine surgery with 24 hours morphine consumption~   "
52141|NCT02884427|"~     The design aims to investigate the value of direct current, specifically the polar effects~     this has, and its influence on neuromuscular changes described in the literature. This~     research proposal seeks to assess the influence of application anode and cathode pole in~     muscle strength when testing handgrip dynamometry by healthy subjects. The study will~     evaluate changes in muscle strength when performing a manual dynamometer test in a group~     exposed to the application of cathode, another exposed to the application of anode, compared~     with a control that will not receive the intervention will be evaluated. Subsequently the~     investigators proceed to compare the maximum force obtained from the dynamometry test in each~     of groups and between the groups .~   "
52142|NCT02884414|"~     The purpose of this study is to quantify differences in joint mechanics between different~     types of walking in healthy individuals and individuals with knee pathology. The~     investigators will determine how modifying gait through feedback and/or cutaneous stimulation~     changes joint loading.~   "
52143|NCT02884401|"~     This is a prospective case series study aiming to evaluate the effect of post-menopausal~     osteoporosis on the jaw bone around dental implants with a modified titanium surface. The~     study consists of 8 visits that will be performed within a minimum period of 15 months.~     Participants will be recruited from the Rheumatology Department and Radiology Department at~     Barts Health National Health Service (NHS) Trust.~      Participants will include 20 post-menopausal osteoporotic women with a requirement of a tooth~     to be replaced. The main objective of this study is to radiographically compare alveolar~     (jaw) bone changes in width and height after the placement of a dental implant with a~     hydrophilic (SLActive) surface and 12 months after loading (placement of the crown) it in~     post-menopausal osteoporotic women.~   "
52144|NCT02884388|"~     The purpose of this study is to validate the hypothesis that a combined nerve block produces~     better outcomes including intraoperative stress, hemorrheological indexes, postoperative~     immune function, and incidence of postoperative complications than general anesthesia.~   "
52145|NCT02884375|"~     The management of older patients with cancer has become a major public health concern in~     Western countries because of the aging of the population and steady increase in cancer~     incidence with advancing age. Cancer treatment of aged patients is complex due to~     comorbidities, polypharmacy and functional status. The heterogeneity of the older population~     in terms of comorbidities and functional status may explain the difficulty in establishing~     management recommendations.~      Study hypothesis is that a geriatric consultation using Geriatric Assessment (GA) can~     evaluate patient's resource and strengths, in order to help oncologist to define the most~     effective treatment. The GA developed by geriatricians and recommended by the International~     Society of Geriatric Oncology (SIOG), is a multidimensional assessment of general health~     status; comorbidities; functional status; nutritional, cognitive, psychological, and social~     parameters; and medications. The GA uses validated geriatric scales to produce an inventory~     of problems, which can then serve to develop an individualized geriatric intervention plan;~     it may be an important step in selecting elderly patients for cancer screening and treatment.~      The objectives are:~        -  To assess the role of GA for decision making process for older patients with cancer~        -  To identify geriatric and oncologic factors associated with overall survival, treatment~          feasibility, toxicities, morbidities~        -  To develop and/or validate screening tests for frailty in geriatric oncology~        -  To develop and validate frailty classifications~      Method: The ELCAPA (ELderly CAncer PAtient) survey is a French multicentric prospective study~     that includes all patients age 70 years or older who has a diagnosis of solid cancer or~     hematologic malignancies in French hospitals~   "
52146|NCT02884362|"~     In research on melanoma, translational research is the essential link between basic research~     and clinical research by facilitating the passage between discovery and improvement in the~     quality of patients care.That is the reason why it is very important to collect, and~     centralize clinical and biological data of patients with melanoma.~      The aim of the project is to provide to scientific community a structured, mixed clinical and~     biological database, unique in France, in order to insure accessibility to clinical data.~   "
52147|NCT02884349|"~     The aim of the study is to determine the influence of the combined anteversion of acetabular~     cup and the femoral stem used in total hip arthroplasty on the theoretical and actual range~     of motion of the hip in three dimensional space.~   "
52148|NCT02884336|"~     Case Description osteoarthritis + amputation of the distal phalanx of the right thumb caused~     by Lactobacillus plantarum after an orange peel. The natural habitat of the bacteria being~     the orange zest and the bacteria is considered harmless.~   "
52150|NCT02884310|"~     Individually-tailored administration of the opioid analgesic component during general~     anaesthesia is still a challenge for the anesthesiologist. The aim of this protocol is to~     look if the gradient response of a nociception index to a calibrated tetanic stimulus during~     standard anesthetic conditions, could help to titrate remifentanil analgesia before tracheal~     intubation and before skin incision. The studied parameters are the SPI index developed by~     General Electric, the Analgesia Nociception Index and the pupil dilation using the pupil~     scan algometer.~   "
52151|NCT02884297|"~     The purpose of this study is to evaluate the feasibility of the measurement of the placental~     perfusion during the first trimester of pregnancy by 3D Doppler ultrasound angiography with a~     contrast agent: SonoVue®.~   "
52152|NCT02884284|"~     In order to accelerate border crossing between basic research and clinical research in breast~     cancer, it is necessary to easily use clinical and biological data. That is the reason why it~     is very important to create a clinical, biological and pathologic beast cancer database,~     mainly prospective but also retrospective. All data are from patients treated in Toulouse~     Centre.~      The scientific community will easily have access to clinical and biological informations~     through a centralized, structured database , leading to optimize patients with breast cancer~     treatment.~   "
52153|NCT02884271|"~     In the last ten years patient safety during routine surgical interventions has increased;~     however as there is an increase in the number of specialized surgical interventions and high~     risk patients like elderly and emergency patients, the incidence of perioperative cardiac~     arrest has not reduced but remains fixed. The incidence of perioperative cardiac arrest~     varies from 4.3-34.6 for each 10,000 procedures. However as in a lot of other countries exact~     data are lacking also for Turkey. With this study the investigators want to start collecting~     data about intraoperative cardiac arrest in Turkey, starting at their institution The aim is~     to evaluate the incidence and outcome in the study. Secondary aim is to assess the causes of~     cardiac arrest in the operating room.~   "
52154|NCT02884258|"~     This case-control study compares IVF results and live birth rates in women undergoing IVF~     with a history of bariatric surgery as compared to women without bariatric surgery history~     and matched for BMI and age.~   "
52155|NCT02884245|"~     E2 given in late luteal phase can be extended beyond the onset of menses for a period of at~     least eight days before the start of the stimulation, allowing scheduling of stimulation in~     order to limit oocytes retrievals during weekends .~      Administration of corifollitropin alfa, a Follicule stimulating Hormone (FSH) with extended~     release kinetics, seems particularly interesting for a synchronous recruitment of follicles~     after homogenization of the cohort.~      The objective of this study is to evaluate the impact on the response to ovarian stimulation~     with corifollitropin alfa of E2 scheduling versus no scheduling for women over 38 years, age~     at which declining of ovarian reserve usually begins. The management of these patients in~     terms of organization of the center is also evaluated.~      The scheduling of IVF cycles represents a double benefit. On one hand, to enable a~     synchronization of the follicular cohort for a best response and a higher number of mature~     oocytes. On the other hand, a more efficient organization for both the center (avoiding~     retrievals on weekends and public holidays, organize and distribute equally the activity,~     reduce cost operations) and couples (personal and professional organization).~   "
52156|NCT02884232|"~     The purpose is to evaluate feasibility of medical supervision of professionally active~     asymptomatic wood workers with questionnaires and nasofibroscopy.~      Secondary purposes are:~        -  Feasibility evaluation of identification of former and actual professional expositions~          to wood dust and to various naso-sinusal carcinogenics in case of co-expositions~          (formaldehyde, chrome, nickel, leather)~        -  Description of abnormal symptoms identified by occupational doctor and needing an~          otorhinolaryngology test~        -  Description of results and examinations induced by nasofibroscopy in symptomatic or~          asymptomatic individuals: counting of naso-sinusal adenocarcinoma cases~        -  Evaluation of participation of workers retiring in 2 years after inclusion to medical~          supervision program~        -  Evaluation of information flow among different players~        -  Assessment of costs induced by this targeted screening: direct medical costs (screened~          pathologies, induced additional examinations…) and indirect costs for company (duration~          of worker absence for transfer, medical and additional examinations).~   "
52157|NCT02884219|"~     Much controversy exists about the optimal management of a patent ductus arteriosus (PDA) in~     preterm infants, especially in those born at a gestational age <28 weeks and/or a birth~     weight ≦1000 grams due to a lack of evidence for or against different approaches. A PDA has~     been associated with serious complications. However, a common finding is that medical and/or~     surgical treatment of a PDA seems not to reduce the risk of mortality or major morbidity.~     This might be related to the fact that a substantial portion of preterm infants are treated~     unnecessarily, because the ductus arteriosus (DA) might have closed spontaneously without any~     specific intervention. An expectative approach is gaining interest, although convincing~     evidence is still missing.~      The objective of this study is to investigate whether in preterm infants <28 weeks' gestation~     with a PDA an expectative management is not inferior to early treatment with regard to the~     composite of mortality and/or necrotizing enterocolitis (NEC) and/or bronchopulmonary~     dysplasia (BPD) at a postmenstrual age of 36 weeks.~   "
52158|NCT02884206|"~     The purpose of this study is to evaluate the effect of LCZ696 compared to valsartan on~     cognitive function in patients with chronic heart failure and preserved ejection fraction.~     Cognitive function will be assessed using a comprehensive battery of tests with an evaluation~     of longitudinal change of cognitive domains including memory, executive function, and~     attention.~   "
52188|NCT02883816|"~     The main objective of this study is to show that there is a concordance between lung disease~     at 13 months and the existing 9 weeks in newborn babies with cystic fibrosis~     asymptomatically.~      This will identify at the first examination at 8 weeks, newborns who have the most impaired~     lung function at 13 months. To meet this objective an assessment of their lung function at 9~     weeks and 1 month will be performed in newborns diagnosed with cystic fibrosis.~   "
52320|NCT02882100|"~     This study is powered to prospectively evaluate the relative effectiveness of adjuvanted~     trivalent influenza vaccine (aTIV; FLUAD) in preventing influenza mortality, hospitalization,~     and functional decline in a nursing home population in the U.S., compared to the commercially~     available, standard dose trivalent seasonal influenza vaccine (TIV; Fluvirin).~   "
52159|NCT02884193|"~     Cryotherapy has a wide range of clinical applications in rehabilitation, used for activities~     such as controlling inflammation, pain control or management of edema after an injury or~     surgery. In the field of cryotherapy they studied cold neuromuscular responses, where it has~     shown a decrease in nerve conduction velocity, which leads to a decrease in muscle strength.~     However it has been described in some work applications brief cold (Quick Icing) may be~     opposite to those described effects, increasing the strength, the time of intervention the~     most important and decisive in these possible improvements or decreases factor. This effect~     is observed in response to a few seconds of application of cold, and would be given by an~     increased activity of motor neurons. Assess the influence of rapid cooling application~     (Technique Quick Icing) and prolonged cooling in handgrip strength when performing a manual~     dynamometer test in college students.~   "
52160|NCT02884180|"~     Trial name: DEXRAR: Dexamethasone in revision arthroplasty: A randomised, blinded, 2-group~     clinical trial~      Trial acronym: DEXRAR~      Background: Effective postoperative pain management is essential for the well-being and~     rehabilitation of the surgical patient. No gold standard exists for pain treatment after~     revision total knee arthroplasty (TKA) and combinations of different medications are used~     with virtually no evidence for combined analgesic efficacy.~      Objectives: The objective is to investigate the analgesic effect and safety of dexamethasone~     as a single dose after revision-TKA in combination with paracetamol, ibuprofen and local~     infiltration analgesia~      Intervention: The patients are randomised into to groups: A) 24 mg dexamethasone i.v. B)~     isotonic saline i.v.~      Design and trial size: Placebo controlled, parallel 2-group trial with adequate centralised~     computer-generated allocation sequence and allocation concealment with block size of 12.~     Blinding of assessor, investigator, caregivers and patients.~      Sample size: 108 eligible patients are needed to detect a difference of 11,3 mg morphine for~     the first 24 h postoperatively with a standard deviation of 20 mg, a type 1 error rate of~     0,05 and a type 2 error rate of 0,20.~   "
52161|NCT02884167|"~     Constipation is a symptom based disorder with a prevalence of 15% in the adult population and~     its management remains challenging. Although not life threatening, constipation is associated~     with impaired quality of life, increased healthcare costs and excess work absenteeism.~     Constipation represents a heterogeneous disorder with a multifactorial pathogenesis. Several~     risk factors have been suggested to lead to the condition and are divided in 3 main~     categories: a) physiological, b) environmental and c) demographic. To date, there is lack of~     large epidemiological studies on proposed aetiological factors of constipation, especially~     studies assessing all proposed risk factors of constipation together.~      The overall aim of this study is to investigate the multidimensional (physiological,~     environmental and demographic) predictors of constipation with the use of a multivariate~     analysis statistical model.~      This is a large single centre case control study comparing constipated adults with healthy~     individuals matched for age, gender and ethnicity.~      The duration of the study is 2 weeks in total and includes a screening visit, a 2 week run-in~     period and a baseline visit at the end of the run-in period. Transit time between constipated~     and healthy individuals is assessed at baseline visit. Differences in gastrointestinal~     symptoms, dietary intake as well as differences in stool output (e.g. stool frequency and~     consistency) between constipated and healthy individuals are assessed over the baseline~     period (the week before the baseline visit). Differences in female sex hormone levels as well~     as stool markers and markers of fermentation (e.g. fecal water, stool pH, short chain fatty~     acids) between constipated and healthy individuals are assessed at baseline visit.~     Furthermore, differences in environmental measures (physical activity, anxiety, smoking) and~     differences in demographic measures (age, gender, body mass index) between patients suffering~     from constipation and healthy individuals are also assessed at baseline visit.~   "
52162|NCT02884154|"~     The exact incidence of subepithelial tumors (SETs) in the gastrointestinal (GI) tract is~     unknown, but the prevalence of gastric SETs detected during routine~     esophagogastroduodenoscopy is 0.36%. GI SETs may include leiomyoma, GI stromal tumor (GIST),~     schwannoma, lipoma, cyst, or ectopic pancreas. Surgical resection is the principal diagnostic~     and therapeutic method for SETs, especially for large and symptomatic ones. Preoperative~     pathological diagnosis of SETs may facilitate clinical decision making, but conventional~     endoscopic forceps biopsy does not yield adequate amounts of subepithelial tissue for~     definitive diagnosis.~      Although endoscopic ultrasonography (EUS) is the best imaging modality for the evaluation of~     SETs, it cannot substitute histopathological diagnosis. EUS-guided fine-needle aspiration~     (EUS-FNA) may provide adequate amounts of tissue for the diagnosis of SETs, but it does not~     always afford adequate samples for immunohistochemical analysis because of the often small~     number of cells obtained by aspiration. Since some SETs, especially GI mesenchymal tumors~     such as GIST or schwannoma, have varied morphologic appearances, and diagnosis using a small~     biopsy is not straightforward, immunohistochemical analysis is strongly advisable, if not~     essential. EUS-guided Trucut biopsy (EUS-TNB) may overcome the limitations of EUS-FNA in~     procuring sufficient core tissue specimens. Although EUS-TNB is more accurate than EUS-FNA~     for diagnosing GI mesenchymal tumors, the rigidity of its 19-gauge (G) caliber and the~     mechanical friction of the firing mechanism produced by the torqued echoendoscope limit its~     use for SETs located in the gastric antrum and duodenum. Therefore, a needle facilitating~     adequate histological core sampling with easy maneuverability needs to be established. A 19G~     EUS-guided fine-needle biopsy (EUS-FNB) device with ProCore reverse-bevel technology was~     recently introduced. A multicenter study revealed that histological samples could be~     successfully obtained using this needle in most patients having GI SETs, with a diagnostic~     accuracy of >80%.10 However, because of technical difficulties with this needle in the~     gastric antrum and duodenum, the same FNB device was recently developed in a 20 G platform~     with coiled sheath. This prospective, multicenter study aimed to evaluate feasibility, yield,~     and diagnostic accuracy of a newly developed 20 G ProCore needle with coiled sheath in~     patients with GI SETs.~   "
52163|NCT02884141|"~     ARCADIA is a national registry designed to document phenotypic and genetic traits in patients~     with renal and/or cervical artery fibromuscular dysplasia (FMD).~      FMD is a group of arterial diseases that most commonly involve renal and carotid arteries.~     Patients with FMD may present with renovascular hypertension and/or with cerebrovascular~     symptoms. Angiographic classification includes the multifocal type and the focal type. FMD~     may affect one or more vascular beds and progress to more severe stenosis and to renal or~     cerebrovascular complications. FMD may be familial (OMIM #135580).~      Our main objective is to create a FMD registry that will collect standardized information~     from all consenting patients diagnosed with the condition in 16 participating centers. This~     registry, along with a collection of leukocyte DNA, will constitute a resource for further~     clinical research on FMD. The first application will be the assessment of the frequency of~     multi-site FMD, i.e. the frequency of cervical artery FMD in patients presenting with renal~     artery FMD and vice-versa. The second application will be a case-control study to identify~     susceptibility genes for FMD.~      Patients are eligible in the registry if: (a) they have renal or cervical artery FMD with~     either multifocal or focal lesions at CT-angiography, MR-angiography, or intra-arterial~     angiography; (b) they give informed consent to leukocyte DNA analysis and to the collection~     of bioclinical and morphologic information. Phenotypic assessment will be performed in~     accordance with current recommendations and best clinical practice.~      Given the multicenter nature of the study and the recruitment capacity of each centre,~     enrollment of 500 FMD cases is expected over 5 years. This number will 1) allow an accurate~     estimation of the frequency of multi-site FMD: when the sample size is 500, a two-sided 95%~     confidence interval will extend 0.035 from the observed proportion for an expected proportion~     of 0.20 based on a previous report and from our unpublished data. 2) In addition to a~     collection of 400 renal FMD already collected at HEGP, give sufficient power for a~     genome-wide association study seeking for susceptibility genes~   "
52164|NCT02884128|"~     This trial is a multi-center, open-label, phase I, dose escalation study of PEP02 (liposomal~     encapsulated irinotecan) in combination with 5-FU and LV in patients with advanced solid~     tumors.~   "
52189|NCT02883803|"~     The main purpose at the early phase of septic shock on the evolution of organ failure judged~     by the SOFA (Sepsis Organ Failure Assessment score) score on Day 7 (or the day of death or~     the day of discharge from the intensive care unit if before Day 7) compared to SOFA score~     observed in patients in the control group. The secondary purpose is to assess the role of~     heterologous mesenchymal stem cells on the occurrence and duration of failure of each organ~     and on the mortality at day 28 and day 90. The safety of administration will be also~     assessed.~   "
52165|NCT02884115|"~     A continuing challenge to determining the response to treatment of early syphilis (primary,~     secondary, early latent syphilis) is exemplified by the substantial proportion of patients~     who fail to achieve serological cure and remain serofast. Although retreatment is often done~     in clinical practice, optimal management remains uncertain due to the paucity of data~     regarding serological response to retreatment and long-term outcomes. Furthermore, the~     investigators cannot rule out that the gradually increasing seroreversion/serological cure~     rates may have been due to the natural decline in rapid plasma regain (RPR) titers after~     initial therapy, rather than due to the additional dose of benzathine penicillin. Thus, the~     investigators would like to conduct a clinical trial to compare the serological response~     rates of serofast early syphilis cases retreated with three doses benzathine penicillin and~     absence of any retreatment (control group).~   "
52166|NCT02884102|"~     Here we propose an integrative sequencing approach utilizing a 1500 gene exome comparative~     analysis between multiple myeloma or related plasma cell malignancies and normal cells~     coupled to capture transcriptome sequencing to provide a nearly comprehensive landscape of~     the genetic alterations for the purpose of identifying informative and/or actionable~     mutations in patients with multiple myeloma and plasma cell malignancies. The approach will~     enable the detection of point mutations, insertions/deletions, gene fusions and~     rearrangements, amplifications/deletions, and outlier expressed genes among other classes of~     alterations.~   "
52167|NCT02884089|"~     This study will look at how a single dose of abemaciclib will impact the body's ability to~     get rid of two other drugs, metformin and iohexol. In addition, this study will evaluate the~     effect of a single dose of abemaciclib on kidney function by measuring blood and urine~     markers. Side effects will also be documented.~      Each participant will complete four study periods. During each study period, participants~     will stay in the clinical research unit for nine days and eight nights.~      The study will last approximately 10 weeks, not including screening. Screening is required~     within 28 days prior to the start of the study.~      This study is for research purposes only and is not intended to treat any medical condition.~   "
52168|NCT02884076|"~     To validate the ability of the Sodergren score in guiding the management of symptomatic~     haemorrhoids in a Malaysian population.~   "
52169|NCT02884063|"~     In the way for developing and optimizing protocol to be used as non- invasive methodology~     used as routine testing for PGS.~      This protocol is to be adapted to replace the using of life embryo cells for genetic testing~     and aneuploidy study as well as for any type of genetic testing including single gene~     disorder or HLA typing or study.~   "
52170|NCT02884050|"~     Data generated from this pilot project will be used to support a larger, NIH funded study to~     investigate the physiologic mechanisms associated with the cognitive side effects of a~     commonly prescribed antiepileptic drug (AED), topiramate (TPM). This study will provide pilot~     data to 1) demonstrate the viability of using quantitative electroencephalogram (EEG) to~     examining physiological effects of AEDs as they relate to language function, and 2) perform~     formal power estimate calculations in support of a longer-term connectivity study using~     stochastic modeling techniques including power, coherence, and Granger causality metrics to~     analyze AED effects on quantitative EEG. Traditionally, the cognitive side effects of AEDs~     have been considered a byproduct of decreased neuronal excitation associated with medical~     therapy, although recent data suggests that this may not be true for some newer medications,~     such as TPM. The proposed experiments will employ quantitative EEG to investigate the effects~     of topiramate on neuronal network connectivity and pharmacokinetic/pharmacogenetic~     relationships in order to explore individual physiological responses. Topiramate is selected~     because of its relatively unique effects on generative verbal fluency, but unlike older AEDs,~     TPM is associated with little EEG change. The investigators will compare the effects of TPM~     to baseline and an inactive placebo in a randomized double blind crossover design.~   "
52171|NCT02884037|"~     In this multicentric, double-blind, randomized,placebo-controlled study, the investigators~     hypothesized that rifaximin might act on Gram-negative bacteria and intestinal bacterial~     overgrowth(IBO) thereby inhibiting lipopolysaccharides(LPS)-mediated proinflammatory cytokine~     production. This work evaluates the efficacy of 6 months administration of rifaximin in NAFLD~     patients.~   "
52172|NCT02884024|"~     An observational study designed to compare colonic cytokine concentrations in lean versus~     obese individuals~   "
52173|NCT02884011|"~     Retrospective study to examine the effects of chronic antihypertensive medications on~     vasopressor dosing in septic shock~   "
52174|NCT02883998|"~     To determine whether home-based physical therapy (HBPT) is not clinically inferior to formal~     outpatient physical therapy (OPT) after hospital discharge of patients undergoing a~     unicompartmental knee arthroplasty (UKA).~   "
52175|NCT02883985|"~     The purpose of this study is to determine whether high dose of radiation therapy (RT) are~     effective over standard 6-week radiation treatment in patients with breast cancer~   "
52176|NCT02883972|"~     This study will investigate whether influenza vaccine uptake by school-age children (in~     school-based clinics) can be increased by making behavioural-insight informed changes to the~     invitation process which encourage parents to return consent forms.~   "
52177|NCT02883959|"~     Pain is a common problem encountered in about 60 % of critically ill patients who can~     communicate. Its occurrence can be related to several causes, mainly dominated by invasive~     procedures.~      Pain management is typically based on a combination of prevention, evaluation, and~     therapeutic agents. However, it appears important to develop adjuvant approaches. Music~     therapy is one of them and that has been evaluated in various medical conditions.~      The aim of our study is to evaluate the analgesic effect of music therapy in critically ill~     patients during potentially painful nursing procedures.~   "
52190|NCT02883790|"~     The aim of this placebo-controlled randomized study is to evaluate the effects of Melatonin~     1mg/Zn 30% VNR/Mg 100% VNR (food supplement) in the management on sleep quality and mood~     alteration in cancer patients~   "
52309|NCT02882243|"~     This investigation will provide safety and effectiveness information on the use of the~     FLXfit™ Cage. Data will be used for Post Market follow-up of the FLXfit™ system by~     evaluating:~        -  Safety as measured by the rate of serious operative and post-operative complications.~        -  Patients' quality of life, measured by health-related quality of life questionnaires up~          to 24 months following the procedure, as compared to patient's baseline.~   "
52178|NCT02883946|"~     Hairy-cell leukemia is a rare and indolent lymphoid disorder, representing 2% of all cases of~     lymphoid leukemias. Treatment of hairy-cell leukemia relies mainly on the purine analogs,~     cladribine and pentostatin, which have shown similar efficacy and constitute the gold~     standard of care either as front-line therapy or for relapsed patients.~      However, despite the remarkable response rates obtained with purine analogs therapy, some~     patients will eventually relapse and the efficacy of these agents seems to decrease at each~     line of treatment. The addition of new molecules to purine analogs may improve the response~     rates and prevent relapse.~      Rituximab is a chimeric IgG1 kappa-type monoclonal antibody directed against the CD20~     molecule. It was first used in relapsed patients with hairy-cell leukemia more than 10 years~     ago and several series of patients treated with rituximab as monotherapy were published in~     the following decade, reporting response rates ranging from 25% to 80%.~   "
52179|NCT02883933|"~     The worldwide incidence of cutaneous melanoma has been increasing for the last 30 years in~     western populations. Among all melanomas, those located on the head and neck are more~     frequent than expected regarding the surface of this anatomical area, occur in older subjects~     than melanomas at other sites and have a worse prognosis than melanomas at other sites. The~     question whether head and neck melanomas could be a distinct entity has been debated.~   "
52180|NCT02883920|"~     Work related asthma and rhinitis are frequent diseases with a significant morbidity and a~     social and economic impact. Farmers are highly exposed to various inhaled agents such as~     organic or inorganic dust, endotoxin, micro-organisms, pollen, mites, moulds, animal danders~     and pesticides, inducing rhinitis, asthma, chronic bronchitis, hypersensitivity pneumonitis~     and organic dust toxic syndrome. Work related respiratory symptoms are frequent in crop~     farmers. Allergic rhinitis and respiratory symptoms in fruit farmers are mainly related to~     pollen allergy, especially gramineae pollen. They can also be related to the use of~     pesticides or exposure to mites .~   "
52181|NCT02883907|"~     The utility of conventional imaging in the development of new treatments for osteoarthritis~     (OA) is hindered by:~        1. Difficulty in non-invasively evaluating the initial response to potential new treatment~          options. OA typically develops over a long time period, so evaluating the efficacy of~          new treatment options over a timeframe relevant to experimental medicine studies is~          difficult.~        2. Inadequate methods of disease quantification and stratification. OA is a heterogeneous~          condition and identifying which subgroups of patients are most likely to benefit from~          new treatments is crucial.~      Novel magnetic resonance (MR) imaging acquisition and analysis techniques have the potential~     to solve these problems. However, their reliability needs to be fully established and~     knowledge of likely effect sizes is required to inform sample size considerations for further~     longitudinal/interventional studies.~      This study aims to help address these issues by:~        1. Calculating effect sizes for MR measurements to inform sample size calculations for~          future studies.~        2. Assessing the reliability of a multiparametric MR protocol for assessment of the knee~          joint.~      The investigators will examine a single knee of an initial 15 participants with MR.~     Participants will be drawn from two groups: (1) 10 participants aged 40-60 years old with~     clinical and x-ray features of OA and (2) 5 control subjects (matched to cases for age, sex~     and body mass index in a 1:2 ratio) who do not have clinical features of OA.~      Participants will undergo an initial (baseline) MR examination, followed by repeat MR~     examinations at approximately 1 month and 1 year following the baseline examination.~      This will allow us to assess both the reliability of our MR measurements and the expected~     progression in our MR measurements in OA subjects in the absence of any disease-modifying~     intervention.~   "
52182|NCT02883894|"~     Bullous pemphigoid is the most common subepidermal autoimmune blistering disease of the skin~     in European countries, including France.~      Immunologically, BP is characterized by the production of autoantibodies directed against two~     major components of the hemidesmosome, BP180 and BP230.~      The anti-BP180 autoantibody is detected in 79-93% of cases of bullous pemphigoid and its~     serum level at diagnosis have been correlated with disease activity. The anti-BP230~     autoantibody is detected in 57%-63% of bullous pemphigoid cases and its score at diagnosis~     did not correlate with disease activity.~      Up to now, no clinical or immunologic factors have been identified to predict outcome of~     patients with good or poor prognosis bullous pemphigoid as defined by long complete remission~     off therapy and recurrent disease requiring maintenance therapy for years. The usefulness of~     BP180 or BP230 ELISA scores for monitoring BP patients during treatment also remains unclear.~   "
52183|NCT02883881|"~     determination if, within a keratoconic population, strong eye rubbing was correlated with~     visual acuity, spherical equivalent value, biomicroscopic signs, corneal pachymetry,~     keratometry, and tomography classification determinating keratoconus stage.~   "
52184|NCT02883868|"~     To assess the association between stromal demarcation line after collagen crosslinking (CXL)~     for progressive keratoconus and mid-term (6 month) refractive, topographic and clinical~     outcomes of CXL~   "
52185|NCT02883855|"~     The aim of this study to determinate if there is a correlation between visual acuity gain in~     patients who underwent a Descemet's stripping automated endothelial keratoplasty (DSAEK)~     corneal keratoplasty and the central thickness of the graft.~   "
52186|NCT02883842|"~     The study is a two-arm, parallel, randomized clinical trial. The purpose of the study is to~     evaluate the effectiveness of automated mobile phone text message-based intervention for~     secondary prevention, including lifestyles modification, medication adherence improvement and~     risk factors control among coronary heart disease (CHD) patients with diabetes. The~     participants will be randomized into intervention and control groups in a 1:1 ratio. The~     intervention group will receive 6 pre-designed text messages per week in addition to usual~     care for 6 months, while the control group will receive usual care.~   "
52187|NCT02883829|"~     Adolescence and emerging adulthood are critical periods during which health outcomes may be~     imperiled for youth with Type 1 Diabetes (T1D). Due to the strong presence of alcohol use in~     the college environment, college students with T1D may be especially vulnerable to these~     risks.~      Our goal is to develop preliminary evidence in support of a scalable intervention targeting~     diabetes health management and alcohol use avoidance for college youth with T1D. For this~     project the investigators will engage at least 120 youth with T1D in college. The study~     sample will be drawn from two national, non-profit, peer support based groups: the College~     Diabetes Network (CDN) and the TuDiabetes Network.~      The study aims to 1) develop and pilot and educational video intervention; 2) determine the~     acceptability and efficiency of various web platforms for engaging college students in~     completing a survey about their health and alcohol use and to; 3) compare effectiveness of~     delivery of a brief intervention delivered by a peer versus a provider. The investigators~     plan to engage 120 college youth with T1D in completing a survey about their health knowledge~     and alcohol use behaviors.~      Baseline survey items will ask participants about knowledge, attitudes, and practices/plans~     for diabetes self-management and alcohol use in college. In response to survey items,~     participants will provide information on topics including general and disease-specific health~     information, as well as attitudes, behavior, beliefs, and knowledge related to alcohol use.~     Participants will also respond to questions relating to social support, mental health, and~     perseverance and commitment to long term goals.~      Following the baseline survey, participants will be presented with a brief educational video~     about diabetes self-management and alcohol use risks. Participants will be randomized to~     receive one of two educational video interventions. One version will be framed and delivered~     from a peer-based source and the other from a provider, content will otherwise be identical.~     Participants will receive 2 follow-up surveys; one immediately following viewing the video~     and the second two weeks later. Both the immediate follow-up and the 2-week follow-up survey~     will test salience, recall, and effects on health knowledge, beliefs and behavioral~     intentions.~      While the main purpose of the pilot is to ascertain preferences in the absence of preliminary~     data, our a priori hypothesis is that peer delivery will have greater impact for this~     population.~   "
52191|NCT02883777|"~     This study is a randomized clinical trial, which will follow and evaluate 120 kidney~     transplant recipients over one year. There will be two groups: a control group and the~     intervention group. The dietitian visits will happen monthly during the first six months and~     twice in the last six months.The intervention group will receive a high-protein and low~     glycemic index diet (1,3g/kg/day of protein) and the control group will keep following the~     hospital standard protocol. The study assessments (weight, anthropometry and biochemistry)~     will be performed during these visits over one year after the randomization period.~   "
52192|NCT02883764|"~     Employees working at DSM workplaces with an onsite Healthyroads Wellness® biometrics~     screening program are being offered an opportunity to have their blood fatty acids levels,~     especially omega-3 fatty acids [omega-3 index] measured at no charge. At some locations,~     participants were offered a single coupon on a 90 day supply of omega-3 capsules. Three~     months later, all employees at these locations are given a second opportunity to have their~     blood omega-3 levels [eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)] measured.~     The goals are to: 1) survey dietary EPA+DHA intake and omega-3 blood levels of study~     population, 2) determine if dietary EPA+DHA intake and omega-3 blood levels change after~     people have learned their omega-3 index, and 3) determine if differences in omega-3 index~     concentrations can be detected 3 months later between locations receiving information alone~     vs information+coupon.~   "
52193|NCT02883751|"~     Diabetes mellitus is a major public health problem and it is estimated that 300 million~     individuals will be affected by the year 2030. Non-diabetic ulcers are one of the most~     frequent complications of this disease and, if untreated, can lead to the amputation of lower~     limbs. Thus, there has been growing interest in the use of light emitting diode (LED) devices~     to accelerate the tissue repair process and lower the cost of ulcer treatment in this~     population. The Mandaqui hospital complex is a general, tertiary, teaching hospital that is a~     reference center for revascularization surgery and endovascular treatment in Brazil. The aim~     of the proposed study is to evaluate the action of LED therapy on the complete healing of~     ulcers following minor amputations in patients with Diabetes mellitus. Methods: A~     single-center, randomized, controlled, double-blind, clinical trial with two parallel groups~     will be conducted following the criteria of the CONSORT Statement. The project will be~     registered with www.clinicaltrials.gov. The sample will be composed of 40 patients with a~     diagnosis of Diabetes mellitus in follow up at the vascular clinic of Mandaqui hospital~     complex who meet the inclusion criteria. The control group (n = 20) will receive traditional~     rayon bandages with essential fatty acids and secondary coverage with gauze, which will be~     changed on a weekly basis. The treatment group (n = 20) will be submitted to LED therapy (635~     nm; 4 J/cm2; 10 minutes) with weekly applications and the ulcers will also receive the~     traditional bandage treatment described above. The patients will be followed up until the~     complete closure of the ulcer, which will be the primary outcome. The ulcers will be examined~     on a weekly basis by a researcher with no awareness regarding the allocation of the~     individuals to the different groups and will assess, signs of infection, edema, redness, heat~     and the presence of gangrene. Photographs of the ulcers will also be taken for the subsequent~     determination of the area. Another researcher with no knowledge regarding the allocation of~     the participants will measure the surface of the ulcers with the aid of the ImageJ software~     program. The data will be submitted to appropriate statistical analyses. After closure of the~     ulcers, the patients will be followed up for a period of six months.~   "
52194|NCT02883738|"~     The main objective of this study is to identify the superficial muscle groups involved in~     gene-related tremor and assess the reduction in the intensity of the tremor after transient~     electrical stimulation.~   "
52195|NCT02883725|"~     The esophageal atresia is a group of birth defects including a break in continuity of the~     esophagus with or without persistent communication with the trachea (tracheoesophageal~     fistula), sometimes associated (from 50%) of other malformations (heart, kidney, digestive~     ...).~      The current prognosis for this ailment is good. However he persists a mortality (<10%) and~     significant morbidity, firstly related malformations (heart, kidney, for example), and~     secondly with particularly difficult anatomical forms (Forms long defect) .~      The prevalence of this condition is estimated to be 1/2500 in 3000 live births, making an~     estimated ± 2,500 new cases over to 10 years in France.~      The current project aims to set up a national registry (Metropolitan France and Dom Tom) to~     measure the prevalence of esophageal atresia among live births, phenotypic characteristics,~     the circumstances of their diagnosis, and their initial future at short-term during the first~     year of life, at which time occurs the vast majority of deaths and complications in this~     disease.~   "
52196|NCT02883712|"~     Pharmacoresistant epilepsy remains around 30% despite the development of 25 anti epileptic~     drugs. Of course, this can be explained by pharmacoresistant epileptic brain diseases, as~     exemplified by some genetic diseases. However, the lack of specific guidelines for the choice~     of the anti epileptic drugs (apart from generalized and partial epilepsy) and the very large~     number of drugs with different and sometimes complex metabolism are challenges for~     neurologists. Among the 30 % of pharmacoresistant epilepsy, there is a part related to~     pharmacokinetic drawbacks that could be overcome with a more rigorous approach (i.e. dosage~     and pharmacogenetics tools). Moreover, the new anti epileptic drugs have metabolism more~     unrelated with the cytochrome P450 and less generalised adverse events. However, their~     metabolism could be more complexe (i.e. the less known Uridine~     5'-diphospho-glucuronyltransferase (UGT) pathway) and bring more insidious neurological~     adverse events (i.e. depression, anxiety exacerbation, cognitive disorders worsening) which~     could largely impede the observance and the quality of life even if the number of seizure is~     reduced or not. The goal is to determine the predictive and the modulating factors of~     pharmacoresistance with a global analysis (i.e. whatever the anti epileptic drugs) and with a~     specific analysis (drug by drug) from a cohort of 1000 patients.~   "
52197|NCT02883699|"~     The TOP Study is a two-stage study on individually tailored endurance and resistance training~     prescriptions for breast and prostate cancer patients after the end of primary therapy in~     order to optimize training effects.~   "
52198|NCT02883686|"~     Depression during pregnancy and postpartum is a major public health problem with adverse~     correlates and consequences for women and their children; although efficacious treatments for~     depression during pregnancy exist, few women receive such care. A widely recognized barrier~     to treatment engagement is the lack of effective, available care that is well aligned with~     women's treatment preferences. To close the gap between treatment need and receipt among~     depressed pregnant women, this study aims to develop and test the effectiveness of~     disseminating behavioral activation, an efficacious and acceptable treatment for depression,~     using peer delivery for pregnant women with depression.~   "
52199|NCT02883673|"~     The purpose of this study is to evaluate the safety and effectiveness of the InPress Device~     in the control and reduction of primary postpartum hemorrhage.~   "
52233|NCT02883231|"~     To observe the changes of plasma mitochondrial DNA (mtDNA) levels in patients with ARDS, and~     to explore its clinical significance.~   "
61373|NCT02763553|"~     The purpose of this study is to assess if an enteral ketogenic feed will cause a ketotic~     state in critically ill patients on intensive care.~   "
52200|NCT02883660|"~     The purpose of this study is to determine whether patients who have been prescribed~     antidepressant medications and have experienced significant adverse effects are more likely~     to be poor metabolizers on the CYP450 (CYP2B6, CYP2D6, CYP2C19, CYP3A4/5+) drug metabolizing~     enzymes and/or homozygous for the short allele of the serotonin transporter (SLC6A4) compared~     to patients who took an antidepressant medication and did not experience significant adverse~     effects but also had minimal or no response to the medication. The target medications being~     studied include escitalopram, citalopram, paroxetine, fluvoxamine, venlafaxine, duloxetine,~     bupropion, vortioxetine, vilazodone, and levomilnacipran only.~   "
52201|NCT02883647|"~     The study is to observe the therapeutic effects and long-term follow-up after ending anti-HBV~     therapy with nucleos(t)ide analogs in patients with chronic hepatitis b.~   "
52202|NCT02883634|"~     We aim to evaluate the long-term effects of 10 sessions of spinal manipulative therapy~     applied in a vertebral region-specific or region nonspecific level immediately after~     treatment and 3 and 6 months after randomization.~   "
52203|NCT02883621|"~     Cap assisted colonoscopy, a simple technique of fixing a transparent plastic cap to the tip~     of the colonoscope, was proven to increase the adenoma detection rate during screening~     colonoscopy by helping to depress and flatten colonic folds, thereby improving visualization~     and decreasing blind mucosal areas. The usefulness of cap assisted upper endoscopy (CAE) is~     still under investigations. The aim of this study is to compare the diagnostic yield of the~     CAE to the standard endoscopy in esophagus.~   "
52204|NCT02883608|"~     Examination of major duodenal papilla (MDP) using a standard forward-viewing~     esophagogastroduodenoscopy (S-EGD) is limited. Until now, side-viewing duodenoscope is the~     modality of choice to examine the MDP. Cap assisted esophagogastroduodenoscopy (CA-EGD) uses~     a cap fitted to the tip of the scope that can depress the mucosal folds and thus improve~     visualization and examination of MDP. The aim of this study is to compare CA-EGD to~     side*viewing duodenoscope for complete examination of MDP.~   "
52205|NCT02883595|"~     The purpose of this study is to determine whether thymosin alpha 1 is effective on improving~     monocyte function and has the desired pharmacologic activity for sepsis~   "
52206|NCT02883582|"~     The purpose for the trial is intended to evaluate safety and effectiveness of an oxyhydrogen~     generator with nebulizer in an adjuvant therapy for patients with severe asthma.~   "
52207|NCT02883569|"~     Purpose: Comparative effectiveness research (CER) between surgical and non-surgical treatment~     for patients with low back pain Hypothesis: There will be significant differences in surgical~     and non-surgical treatment effect in patients who need operation for herniated intervertebral~     disc and spinal stenosis.~   "
52208|NCT02883556|"~     The purpose of this study is to assess the efficacy and safety of pembrolizumab in patient~     with locally advanced or metastatic squamous cell carcinoma of the skin~   "
52209|NCT02883543|"~     Eligible patients are administered with oral icotinib 125mg three times daily for two months,~     in which responsive patients (partial response and stable disease) are randomized (1: 1: 1)~     and receive icotinib plus concurrent radiotherapy, or chemotherapy plus concurrent~     radiotherapy, or icotinib monotherapy.~   "
52210|NCT02883530|"~     The Investigators hypothesise that asthma is not a single disease, but a syndrome resulting~     from several distinct underlying disease processes known as endotypes. There are~     approximately 30,000 genes in humans, and each gene is responsible for the production of a~     particular protein. Using a technique called whole genome expression profiling The~     Investigators have undertaken a small study looking at the activity of all 30,000 genes in~     the airway tissue of people with asthma. This work has identified 3 mutually exclusive~     distinct molecular patterns (endotypes) of severe asthma and has identified other potentially~     important molecular targets (manuscripts in preparation). In particular,the Investigators~     have found that 25-50% of patients have asthma associated with the activity of proteins~     called Th2 cytokines (Th2-high asthma). New treatments are in development that target this~     pathway. However, the Investigators do not know what is driving severe asthma in patients who~     do not express these Th2 cytokines. The aim of this study is to investigate in more detail~     the molecular mechanisms driving severe asthma in patients who do not express Th2 cytokines~     (Th2-low asthma), so that the Investigators can identify new targets for treatment in this~     group. To do this the Investigators will collect airway tissue via a telescope~     (bronchoscope), and analyse gene and protein expression in the tissue. The Investigators will~     then compare the molecular activity between patients with Th2-high and Th2-low asthma, and~     healthy control subjects (data obtained from a parallel study).~   "
52211|NCT02883517|"~     To evaluate the possibility of detecting cell-free circulating tumoral DNA in potentially~     aggressive primary cutaneous lymphomas, the investigator opted to search a representative~     tumor sample mutation in the blood of these patients, by digital PCR. Patients with mycosis~     fungoides, primary cutaneous T-cell lymphoma helper follicular phenotype and primary~     cutaneous diffuse large B-cell lymphoma, leg-type will be included and 4 blood samples will~     be collected during 12 months.~   "
52212|NCT02883504|"~     The non-invasive estimation of left ventricular end diastolic pressure (LVeDP) is a main goal~     for performing an echocardiography in the routine clinical practice. Conflicting evidence~     exists about mitral E/e' ratio reliability for predicting high LVeDP~   "
52213|NCT02883491|"~     The overall goal of this clinical research study is to prospectively assess primary outcomes~     related to pulmonary embolism (PE) that occur immediately (within 5 days) and within 30 days.~     The secondary goal is to compare validated prediction models and a modified European Society~     of Cardiology (ESC) approach that is primarily right ventricle dysfunction (RVD) driven with~     clinical risk assessment being secondary, and with primary outcomes of clinical deterioration~     within 5 days.~   "
52214|NCT02883478|"~     Compare different corneal parameters and visual outcome of corneal collagen cross-linking~     (CXL) with conventional versus accelerated ultraviolet-A irradiation using riboflavin with~     hydroxypropyl methylcellulose.~   "
52234|NCT02883218|"~     The purpose of this study is to understand the impact community-acquired sepsis~     patients'immunosuppression in early stage to prognosis,including mortality and chance of~     secondary infection.~   "
52433|NCT02880631|"~     The purpose of this registry is to evaluate the effect of BAROSTIM THERAPY with the BAROSTIM~     NEO System in the commercial setting in subjects recently implanted under the CE-Marked~     indication for resistant hypertension.~   "
52215|NCT02883465|"~     Extubation is a crucial step when patients are being weaned from mechanical ventilator~     support. Indeed, the patient has to face an increasing burden imposed to the ventilation~     system. The ability to overcome this event will determine the patient survival. A warning~     signal could be very useful is this situation. 2 recent studies have shown that measuring~     diaphragmatic cupolas and muscular fibers thickening fraction could help to spot a population~     with a high risk of diaphragmatic weakness, characterized by a high failure extubation~     rate. This study aims to verify that this kind of group of patients does exist.~   "
52216|NCT02883452|"~     Phase 1 randomized, open-label, multicenter, parallel-group study designed to evaluate~     efficacy, PK and safety between CT-P13 SC and CT-P13 IV in patients with active CD or active~     UC.~   "
52217|NCT02883439|"~     The aim of this study is to investigate and to compare the bioavailability of MP29-02 and~     fluticasone propionate in nasal tissue after nasal application. This may provide a rational~     basis for the use of 1 puff per nostril dosage regimen of the drugs. Clinical experience has~     demonstrated the efficacy of the twice-daily treatment; however, so far, no data are~     available on the local tissue concentrations of MP29-02 after topical application.~   "
52218|NCT02883426|"~     This study will evaluate the safety and immunogenicity of the H3N2v MN 2010/AA ca live~     attenuated influenza vaccine (H3N2v LAIV) in healthy children and adults, 6 to 26 years old.~   "
52219|NCT02883413|"~     The purpose of the current study is to investigate the role of Cognitive Remediation Therapy~     (CRT) as a pre-treatment intervention for adolescents who are hospitalized for Anorexia~     Nervosa (AN). The primary aims are to determine if CRT can result in greater treatment~     engagement post-discharge, increased rate of weight gain post-discharge, reduction in symptom~     accommodation, and increased behavioral flexibility in adolescents and parents.~   "
52220|NCT02883400|"~     To study spironolactone to prevent CNI kidney injury.~   "
52221|NCT02883387|"~     This study will Investigate whether or not preoperative computed tomography (CT) angiography~     will lower operative times and post operative complications for breast reconstruction~     performed with a deep inferior epigastric artery perforator flap (DIEP).~   "
52222|NCT02883374|"~     The purpose of this trial is to evaluate the efficiency and safety of Chidamide in advanced~     cephalic and cervical adenoid cystic carcinoma. Chidamide is given to patients with advanced~     cephalic and cervical adenoid cystic carcinoma with the dosage of 30mg,twice a week, then~     overall survival, event-free survival are accessed for efficiency, and laboratory tests about~     the function of vital organs are accessed for safety.~   "
52223|NCT02883361|"~     The proposed research is a randomized controlled investigation of the efficacy of~     motivational interviewing (MI) to improve adherence to aromatase inhibitors (AI) in a~     community sample of patients with poor adherence to AIs.~   "
52224|NCT02883348|"~     Investigating the predictive value of patient satisfaction with care on 6 months and 1-year~     quality of life.~   "
52225|NCT02883335|"~     The RelSEP aims to register exhaustively every new case of multiple sclerosis (MS) occuring~     in Lorraine a French region, and follow up on them for an indefinite duration, registering~     disease evolution and intercurrent events.~   "
52226|NCT02883322|"~     Objectives: To identify the respective contributions of back-translations and of the expert~     committee in the process of cultural adaptation of patient reported outcome with an~     experimental design in the adaptation process :~      Four translations of a questionnaire will be produced:~        -  A simple translation by two translators, who serves as the basis for the three other~          translations~        -  A translation made with the use of a back-translation.~        -  A translation with review by an expert committee.~        -  A translation the use of a back-translation and review by an expert committee.~      Properties of each translation will be analyzed and compared~   "
52227|NCT02883309|"~     The patient subjected to hemodialysis has a low physical capacity due to being advanced in~     years and the complexity of the process, which is encouraged by family members and caregivers~     who lead them to a total dependence. The Intradialytic physical exercise is presented as an~     alternative to counteract this functional deterioration of patients with terminal chronic~     kidney failure.~   "
52228|NCT02883296|"~     Main purposes of this study are :~        -  Analysis of relapse risk of anal fistulae with prospective follow-up of patients~          undergoing pelvic MRI every 6 months for one year. This monitoring also determines if~          the presence of path of fistulae visible on MRI during inclusion visit is associated to~          increased risk of perianal abscess under infliximab or adalimumab treatment.~        -  Evaluation of interest of new magnetic resonance imaging sequences for detection of~          persistent anal fistulae under infliximab or adalimumab treatment.~      Secondary purposes are:~        -  Description of patients with one or more paths of fistulae visible with MRI after at~          least one year of treatment with infliximab or adalimumab administered for anal fistulae~          and showing a complete healing of fistulae at clinical examination of inclusion visit.~        -  Identification of predictive factors (included the presence of paths of fistulae visible~          with MRI during inclusion visit) of relapse of anal fistulae during the 1-year-follow-up~          after inclusion visit.~   "
52229|NCT02883283|"~     This study explores the potential for a more rapid onset of pain relief when drug~     administration is performed through the epidural needle, a technique of epidural loading that~     provides a rapid and reliable level of labor analgesia without the disadvantages of a~     combined spinal-epidural, and could add a valuable new tool to anesthesiologists.~   "
52230|NCT02883270|"~     This study investigates the effects of Robotic-assisted gait training in non-ambulatory~     patients after Guillain-Barré syndrome.The participants are randomly divided into two~     groups.Patients of the treatment group receive robotic-assisted gait training,while the~     contorls receive conventional rehabilitation.~   "
52231|NCT02883257|"~     The purpose of this study is to locate clinical markers (for example, interviews,~     questionnaires, and computer tasks) and biological markers (for example, physiological,~     blood-based, or electroencephalography measurements) that predict response to cognitive~     behavioral therapy for depression.~   "
52232|NCT02883244|"~     The aim of this study is to evaluate the efficacy of a new interdental cleaning device~     (Soft-Picks Advanced), as compared to a leading brand floss; and, how ease of use can promote~     the establishment of a hygienic routine of cleaning interproximal spaces.~   "
52235|NCT02883205|"~     The cardiac Fabry disease are early, frequent and severe, dominated by the frequency of left~     ventricular hypertrophy. They are responsible for a high morbidity and mortality, reducing~     life expectancy of 15 to 20 years for men. Fabry disease and heart attacks are still~     diagnosed late. This delay in diagnosis is due to the non-specificity of clinical,~     electrocardiographic and echocardiographic disease, but also by a certain ignorance of this~     pathology in the medical community. The importance of early diagnosis of Fabry disease and~     heart disease is well established: enzyme replacement therapy is most effective when~     instituted early, before the onset of irreversible damage such as fibrosis. With the blotter,~     we now have a simple and robust screening tool for Fabry disease, achievable consultation.~     Targeted educational interventions to physicians have shown their effectiveness in improving~     the screening and diagnosis of rare diseases. We offer a prospective observational type~     before / after study, which aims to assess the value of an educational brochure for~     cardiologists to improve the screening and diagnosis of Fabry disease in Normandy.~   "
52236|NCT02883192|"~     Cesarean section is a frequent procedure in the obstetric surgery. The most widely used~     anesthesia technique for cesarean delivery is the spinal anesthesia The incidence of spinal~     anesthesia induced hypotension and bradycardia is high as 60% in the obstetric population.~     The aim of the study is to investigate the effect of the preventive use of Ondansetron on the~     prevention of hypotension~   "
52237|NCT02883179|"~     The aim of our study is to compare the analgesic effect of topical application of~     lidocaine-prilocaine cream and lidocaine infiltration during repair of postpartum perineal~     tears.~   "
52238|NCT02883166|"~     Abiraterone is a selective inhibitor of androgen biosynthesis that potently and irreversibly~     blocks CYP17, a crucial enzyme in testosterone and estrogen synthesis. A pro-drug of~     abiraterone, abiraterone acetate (Zytiga®), was developed to overcome its poor~     bio-availability and is fully converted to the active moiety abiraterone. Abiraterone acetate~     tablets are administered at a fixed oral dose of 1000mg QD in a fasted state in combination~     with 10mg prednisolon daily.~      Abiraterone acetate has a low solubility in aqueous media and a low permeability. The~     bioavailability of abiraterone acetate is significantly influenced when ingested with food.~     Ingesting abiraterone acetate with a low fat or a high fat meal resulted respectively in a 5-~     or 10-fold increase in AUC0-∞. The high and low fat FDA meals used in these food effect~     studies differ largely from breakfasts taken in everyday life (ca. 800-1000 cal). A~     continental breakfast contains 160 to 320 calories of which 25-50% is fat, is more compatible~     with a normal lifestyle and therefore easily sustainable in daily practice. However, the~     effect of a continental breakfast on the absorption of abiraterone is unknown yet.~     Furthermore, increasing healthcare costs are a growing concern in all developed countries.~     Therefore effort should be invested to keep anticancer treatment affordable. A food~     intervention resulting in a better absorption and enhanced exposure to abiraterone, can lead~     to a reduced dose, which could significantly impact health care costs for a tumor which is as~     prevalent as metastatic prostate cancer.~      Therefore the investigators want to perform a bioequivalent study to investigate what dose of~     abiraterone with a continental breakfast equals the dose of 1000mg taken in fasted~     conditions.~   "
52239|NCT02883153|"~     Girentuximab is an antibody against Carbonic Anhydrase IX (CAIX), an antigen that is~     expressed on the cell surface of 95% of clear cell RCC (ccRCC). Zr-89-girentuximab PET/CT~     (Positron Emission Tomography) may be a valuable imaging technique in the diagnosis of~     patients with RCC. The aim of the present study is to show the impact of the~     Zr-89-girentuximab PET/CT on the clinical management of ccRCC patients.~   "
52240|NCT02883140|"~     Non tumor salivary gland diseases are common and include sialadenitis, sialadenosis, stones,~     stricture and ductal dilatation, anatomical abnormalities. A radiological examination is~     required in order to sign the diagnosis, locate precisely the lesions and define the~     therapeutic strategy. Cone beam computerized tomography (CBCT), because of its accessibility~     and the possibilities it offers in terms of image processing, is a potential alternative to~     the conventional sialography and to the MRI sialography, considered as a gold standard~     procedure. Our comparative study, aims to evaluate the diagnostic performance of the 3D-CBCT~     sialography compared to MRI sialography, in patients with non tumor ductal salivary diseases.~   "
52241|NCT02883127|"~     The primary goal of this case control study is to investigate the effect of implementation of~     motivational interviewing with focus on diet and weight gain in addition to the routine~     treatment on prevention of excessive gestational weight gain and fetal growth in pregnant~     women with type 2 diabetes.~      Design: Prospective cohort study where an unselected cohort of all pregnant women with type 2~     diabetes are offered intervention with motivational interviewing in addition to routine~     treatment in the period 2015-2017. For comparison a historical cohort (2013-2015) treated~     with routine treatment only will be studied. With an inclusion period of 2 years, each cohort~     is expected to include 150 participants. The women in the study group will receive one-to-one~     coaching based on the principles of motivational interviewing, every second week throughout~     the pregnancy. Both cohorts receive the same routine care for pregnant women with type 2~     diabetes. An appropriate GWG is targeted. Primary outcome measures are maternal gestational~     weight gain and the infants Large for Gestational Age.~   "
52242|NCT02883114|"~     This study is to evaluate the effect of multiple doses of itraconazole, the potent cytochrome~     P450 enzymes (CYP3A) inhibitor, on the pharmacokinetics of PF-06648671 following a single~     dose administration in healthy subject.~   "
52243|NCT02883101|"~     Number of Patients:~      Study group - Bronchiectasis that is not attributable to Cystic fibrosis~        -  Group 1 - Pulmonary Rehabilitation~        -  Group 2 - Standard care~      Sample size - 20 in each arm~      Study Design:~        -  Randomised controlled trial (RCT)~      All patients who qualify for the study will undergo a detailed evaluation. Baseline~     assessment will include the following parameters:~        -  Anthropometry~        -  Pulmonary Function Tests and Respiratory muscle strength~        -  Cardiopulmonary Exercise Testing (CPET)~        -  Six Minute Walk Test (6MWT)~        -  Severity of dyspnoea (Dyspnoea scale)~        -  Limb muscle strength~        -  Inflammatory markers in the serum - C-reactive protein~        -  Quality of Life~      Patients will then be randomized (using table of random numbers) to either the pulmonary~     rehabilitation group or the standard arm group. After 8 weeks of pulmonary rehabilitation,~     patients will again be reassessed by the aforementioned tools.~   "
84385|NCT02462486|"~     This is a safety and efficacy study of abicipar pegol in patients with neovascular~     age-related macular degeneration.~   "
52245|NCT02883075|"~     Multiple studies have compared spinal anesthetic performed supine versus lateral, with~     varying results, in parturients having elective cesarean section. Needle positioning during~     spinal placement has also been examined. No positioning techniques have demonstrated~     definitive superiority for hemodynamic stability.~      Investigators propose that following spinal placement in the sitting position if the patient~     is placed in a lateral position for 90 seconds prior to turning them supine, hemodynamic~     changes caused by sympathectomy related to the subarachnoid block can be avoided.~      This is the first study to examining the influence of position changes after spinal~     anesthetic placement in the sitting position, which includes hemodynamic variables not~     previously studied including cardiac output, (total peripheral resistance) TPR, TSF, and~     pulse pressure variation (PPV).~   "
52246|NCT02883062|"~     This randomized phase II trial studies how well carboplatin and paclitaxel with or without~     atezolizumab before surgery works in treating patients with newly diagnosed, stage II-III~     triple negative breast cancer. Monoclonal antibodies, such as atezolizumab, may block tumor~     growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as~     carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either~     by killing the cells, by stopping them from dividing, or by stopping them from spreading.~     Giving carboplatin and paclitaxel with or without atezolizumab before surgery may make the~     tumor smaller and reduce the amount of normal tissue that needs to be removed.~   "
52247|NCT02883049|"~     This randomized phase III trial studies how well combination chemotherapy works in treating~     young patients with newly diagnosed B acute lymphoblastic leukemia that is likely to come~     back or spread, and in patients with Philadelphia chromosome (Ph)-like tyrosine kinase~     inhibitor (TKI) sensitive mutations. Drugs used in chemotherapy work in different ways to~     stop the growth of cancer cells, either by killing the cells, by stopping them from dividing,~     or by stopping them from spreading. Giving more than one drug (combination chemotherapy) and~     giving the drugs in different doses and in different combinations may kill more cancer cells.~   "
52248|NCT02883036|"~     Chronic myeloid leukemia (CML) is a myeloproliferative neoplasm companies with the BCR-ABL~     fusion gene encoded by the Philadelphia (Ph) chromosome. The BCR-ABL fusion protein(the~     formation of the chimeric gene BCR/ABL on chromosome 22 and a reciprocal ABL/BCR on~     chromosome 9,it has no expanded name) plays key role on CML leukemogenesis by activating its~     downstream signaling pathway of survival and proliferation. Imatinib, a targeted competitive~     inhibitor of a BCR-ABL tyrosine kinase, changed the clinical treatment and prognosis of CML.~     As its optimized generation, other tyrosine kinase inhibitors (TKIs), dasatinib and nilotinib~     have more potent anti-leukemic activity and less side-effect. However, acquired resistance to~     TKIs is one of the main obstacles to effective CML treatment and is involved in gene~     amplication of ABL tyrosine kinase point mutations. The outcomes of patients with these ABL~     tyrosine kinase point mutations have linked to worse prognosis and higher mortality~     generally. Metabolic adaptations are common in cancer cells, and cancer cells become more~     dependent on mitochondrial biogenesis. Tigecycline, as a broad-spectrum antibiotics, inhibits~     mitochondrial biogenesis as its an interesting side-effect.In recent study,researchers~     indicated that tigecycline can eradicate cancer stem cells by targeting mitochondrial.Here,~     the investigators test tigecycline's anti-leukemic activity to chronic myeloid leukemia in~     vitro.~   "
52249|NCT02883023|"~     Capillary malformations (port-wine stains) consist of abnormally developed capillary blood~     vessels in the skin. To date, laser therapy is the only widely accepted treatment modality~     for capillary malformations, but this therapy has a suboptimal effect in approximately 50-60%~     of patients.~      Intralesional bleomycin injections (sclerotherapy) are a common effective treatment option~     for vascular malformations with blood vessels with larger diameters. However, bleomycin~     cannot be injected adequately in the small sized vessels of capillary malformations. The use~     of an electric field over the tissue (electroporation) may solve this problem: it increases~     cell membrane permeability and therefore promotes localized delivery of drugs, within~     (endothelial) cells.~      Electroporation in combination with bleomycin sclerotherapy ('electrosclerotherapy') may~     therefore offer new therapeutic options for capillary malformations. This proof of principle~     study aims to explore the effectiveness, safety and feasibility of this potential treatment~     option in a within-patient-controlled pilot study.~   "
52250|NCT02883010|"~     Surgical Site Complications (SSC's) are responsible for increased morbidity in patients~     undergoing surgery resulting in prolonged length of stay in the hospital while increasing~     treatment and hospital costs dramatically. Negative Pressure Wound Therapy (NPWT) use on~     closed incisions has been reported in the literature to reduce SSC's including Surgical Site~     Infections (SSI's), with many promising studies in general surgery, including some studies~     using single use NPWT. However, to date, there are very few randomised controlled trials~     (RCT's) using this intervention. When using PICOTM (NPWT) for this indication, patients may~     be discharged from hospital earlier, with the negative pressure incision management in place.~     This has implications in terms of cost savings for the health care system and enables the~     patient to be able to return to their normal daily routine more quickly. The hypothesis of~     this study is that PICO NPWT will reduce frequency of SSC's, in a 30 day follow up period, as~     compared to standard care in patients undergoing colorectal procedures.~   "
52251|NCT02882997|"~     This study will determine the feasibility of using an interactive computer game to elicit~     repetitive practice of paretic arm movements in the homes of community dwelling stroke~     survivors and during non-therapy hours at an inpatient stroke rehabilitation hospital.~   "
52252|NCT02882984|"~     A multi-center phase III randomized controlled study to evaluate the efficacy of~     Hypofractionated SRS (HFSRS) along with EGFR-TKI in patients with brain metastasis from~     non-small cell lung cancer (NSCLC). Assuming that HFSRS is not inferior to EGFR-TKI~     concurrent with whole brain radiotherapy (WBRT), the primary end point is intracranial PFS~     (iPFS), while secondary outcomes included overall survival (OS), evaluation of cognitive~     function, quality of life (QoL) and adverse events.~   "
52318|NCT02882126|"~     This is a multicenter, open-label trial to evaluate the safety of continued therapy with~     subcutaneous Remodulin® in subjects with pulmonary arterial hypertension (PAH) who complete~     the CVT-CV-003 study. The study will include about 50 subjects at up to 10 clinical trial~     centers in China who completed all required assessments in the CVT-CV-003 study. Study visits~     for data collection will occur at month 6 and 12 with yearly visits beyond 12 months until~     the study is discontinued by the sponsor.~   "
52253|NCT02882971|"~     Currently, there is no observational pain scale for use in the outpatient setting for adult~     patients. An observational pain scale can allow for objective measurement of pain in patients~     over time and after treatment without the bias associated with self-report. Currently chronic~     pain patients are asked to rate their pain many times throughout their care, often over~     years. This introduces a bias in reporting as a pain a person is currently experiencing will~     seem more severe then a remembered pain event. A behavioral pain scale would allow for an~     objective measurement of pain that is reliable across multiple raters and comparable over~     time, which can help in judging the success of pain treatments.~   "
52254|NCT02882958|"~     The investigators hypothesize software-based fusion/navigation will be accurate to within 3~     mm of the reference standard of EM fusion. The investigators aim to evaluate the accuracy of~     prostate US/MRI software-based fusion/navigation technology.~   "
52255|NCT02882945|"~     To explore the possible implications of HLA-DRB1*04 alleles in patients with type 2 DM and~     macroangiopathy~   "
52256|NCT02882932|"~     Super Oxidized Solution (SOS) was used in peritonitis and results were compared by using~     normal saline solution in two groups. Abdominal fluid was taken to check for bacterial load~     after giving lavage with SOS solution and in other group normal saline. SOS is a high level~     disinfectant, non-flammable and no special training is required to handle it.~   "
52257|NCT02882919|"~     Health risk screening in adolescent primary care is infrequently performed and results are~     rarely followed by targeted intervention. In response to the need for screening-linked~     interventions, the study team has developed and optimized a web-based, electronic~     Personalized Motivational Feedback tool referred to as Check Yourself v2.0 Based on~     motivational interviewing, a technique to mobilize personal change, Check Yourself is~     designed to promote healthy choices for the multiple behaviors relevant to adolescents.~   "
52258|NCT02882906|"~     One source of shoulder pain can be myofascial trigger points (MTrPs). MTrPs are localized,~     hyperirritable points in the skeletal muscles that are associated with palpable nodules in~     muscle fibres. MTrPs can be classified into active and latent. Latent MTrPs demonstrate the~     same clinical characteristics as active MTrPs but they do not provoke spontaneous pain.~     Numerous studies have shown that MTrPs are prevalent in patients with chronic non-traumatic~     neck and shoulder pain.~   "
52259|NCT02882893|"~     The purpose of this study is to evaluate the Efficacy and Safety of DWP450 treatment of Crows~     Feet Lines(CFL).~   "
52260|NCT02882880|"~     To determine the effectiveness of the Luco Hybrid OSA Appliance in the treatment of sleep~     bruxism and to aid in the treatment of associated tension/migraine type headaches in adults.~   "
52261|NCT02882867|"~     It is well known that participation in sports activities as a youth has several health~     benefits, but at the same time, studies report that the risk is high to obtain injuries~     related to participation. There is, however, increasing evidence that many of these injuries~     can be prevented if necessary measures are taken. Prospective studies are therefore needed to~     be able to plan and carry out measures to prevent the occurrence of injuries. The overall aim~     of the project KLUB is to study the prevalence and incidence of injuries among athletics~     youths aged 12-15 years. A particular focus will be placed on identifying factors associated~     with injury occurrence.~   "
52262|NCT02882854|"~     Postoperative nausea and vomiting (PONV) and pain are the most common causes of Post~     Anesthesia Care Unit (PACU) discharge delay, with untreated PONV occurring in 20-30% of~     post-surgical patients. The effect of guanfacine (GF) administration on pain and nausea~     scores will be assessed with two groups. One group will receive 1 mg of GF to take orally and~     the other group will receive a similar appearing placebo (containing no drug) to take orally.~   "
52263|NCT02882841|"~     The study is a multicenter, international descriptive study with a bio-collection in 300~     evaluable Crohn's disease patients to be processed after usual biological tests via~     bioinformatics tools.~      At this time, this study has no impact neither on treatment nor on disease diagnostic, these~     will be based on usual medical practices and is no investigational product associated with~     the conduct of this study.~   "
52264|NCT02882828|"~     Tools have been developed in our unit to calculate the inter-dose AUC (Area Under Curve) of~     immunosuppressive drugs (ISD) based on a limited number of blood concentrations (i.e., blood~     samples) using Bayesian methods. Since 2005, we have implemented these tools in an expert~     system and made them available to the transplant community through our very successful ISBA~     (Immunosuppressive drugs Bayesian dose Adjustment) website.~      Briefly, we first need to develop a population pharmacokinetic model using rich~     pharmacokinetic (PK) profiles (about 10 samples per patient over the dosing interval). The~     model developed can then be used for inference of ISD PK parameters in new patients using~     Bayesian estimation. Bayes' theorem is based on conditional probability: individual PK~     parameters are estimated based on the known PK parameters in the population (mean and~     distribution), given the dose and concentrations observed in a patient. Our previous studies~     have shown that a limited sampling strategy (LSS) based on 3 samples collected within the~     first 3 hours after drug intake can estimate adequately the interdose AUC of ISD. In the~     present study, the AUC0-24h and the recommended dose will be calculated using Bayesian~     estimators previously developed using PK data from the clinical trials run by Veloxis, and~     proposed to the clinicians via a dedicated website comparable with ISBA.~   "
52265|NCT02882815|"~     The purpose of the study is to collect more data about performance and safety of the device~     called IrisFITTM PFO occluder. This data will be used to help more patients who will accept~     treatment with this device in the future.~      Patients will undergo routine examination, procedure and follow-up. Related data will be~     collected and kept in a way that patient info is well protected.~   "
52286|NCT02882542|"~     NOTE: This is the third of in total 7 sub-studies related to the Ethics Committee of the~     Canton of Bern Ref. No. KEK-BE 2016-00674. This sub-study includes 50 participants and 6~     arms, in total 350 participants will be assessed in all 7 sub-studies.~      General study information: This is a randomized, cross-over, quantitative study, which~     investigates physiological variables, mood, and affect of healthy participants in response to~     colored light exposure. The Participants take part in 5-8 arms and are exposed to colored~     light only, or are additionally asked to solve cognitive tasks during the colored light~     exposure. Primary aim is to measure the change in several physiological variables, mood, and~     affect during colored light exposure of 15 or 45 minutes. The risk for the participants is~     negligible and comparable to the risk during daily life.~   "
52266|NCT02882802|"~     Research has consistently shown that Veterans with PTSD are more likely to experience higher~     levels of anger and commit aggressive acts compared to Veterans without PTSD. Given the~     significant negative impact that anger and aggression can have on the lives of Veterans,~     their families, and society at large, there is a great need to examine novel interventions~     that could decrease anger and aggression risk with this population. Mindfulness may be one~     such technique, given its effectiveness in assisting individuals in regulating difficult~     emotions and in decreasing physiological reactivity, which have both been implicated in PTSD~     and aggression perpetration. Findings showing that a mindfulness intervention is effective in~     reducing anger and aggressive behavior would be relevant for Veterans with PTSD experiencing~     such difficulties and would help prevent the detrimental consequences that can come from~     anger and aggression among these individuals.~   "
52267|NCT02882789|"~     Primary - To investigate the Pharmacokinetics, Safety, and Tolerability of Intravenous dosage~     form of LCB01-0371 comparing to oral dosage in Healthy Male Volunteers Secondary~      • To investigate the absolute bio availability of LCB01-0371 after a single intravenous dose~   "
52268|NCT02882776|"~     This study aims to examine the effect of ginger beverage consumption on platelets activity in~     apparently healthy Saudi adult volunteers.~      As for the Saudi population, consumption of powdered ginger dissolved in hot water is a~     common practice. Accordingly, in this study, it is tempting to speculate the effect of this~     form of ginger consumption, given in separate time points per day, on platelet aggregation~     profile by using platelet aggregation analogues. If positive results were obtained, the herb~     could provide natural protection against the development of platelet aggregation~     complications and could be a potential alternative to aspirin, used for improving blood~     circulation and hematological pathophysiologies in diseased individuals.~   "
52269|NCT02882763|"~     ZEPPELIN (Zurich Equity Prevention Project with Parents Participation and Integration) is a~     longitudinal, randomized controlled intervention study. The main objective is to examine the~     effectiveness of the early intervention program Parents As Teachers (PAT) in psychosocially~     disadvantaged families. This includes four aims:~        1. Identification of children at risk at an early age, using an interdisciplinary network;~        2. Investigation of the acceptability of the program by the parents;~        3. Evaluation of the intervention process and efficacy during and immediately after program~          implementation;~        4. Evaluation of the efficacy in terms of child academic performance.~   "
52270|NCT02882750|"~     This study will monitor the effect on patients reported outcomes (PROMs) of VATS resection~     and SABR for NSCLC delivered at the Leeds Cancer Centre The investigator will support with~     this information the Shared Decision Making (SDM) process.~      300 consecutive patients will be followed up from prior the treatment to 12 months~     afterwards, administering multiple questionnaires (EORTC QLQ C-30 and LC-13, PSQ-18, Decision~     Self-Efficacy Scale) by a remote web-based system.~      Deliverable:~        1. Differences after VATS resections or SABR in terms of physical and psychological~          symptoms, quality of life and satisfaction~        2. Patient perspectives of the Shared Decision Making Process.~   "
52271|NCT02882737|"~     This project is part of several studies exploring situations, where glucagon potential has~     lesser glucose elevating effect. Exercise can be one of these situations as exercise may~     reduce liver glycogen depots.~      The investigators aims are:~        1. To compare the increase in plasma glucose after 200µg glucagon given either after~          exercise or after resting for 45 minutes.~        2. To determine whether a subcutaneous glucagon injection just before exercise has a~          greater impact on hepatic glucose production and thereby is superior to an injection~          after exercise in preventing hypoglycemia during and two hours after exercise.~        3. To compare the accuracy of two Dexcom G4 continuous glucose monitors, (CGM) placed at~          either the abdominal wall or on the upper arm.~   "
52272|NCT02882724|"~     Background: It has been shown that adults with Multiple sclerosis (MS) have less leg strength~     than their peers, as well as impaired balance, which has led to an increased prevalence of~     falls in this population.The purpose of this study was to assess the effects of 8-weeks~     aquatic exercise training in balance, endurance and speed in women with MS.~      Methods: In this semi-experimental study, 32 women with clinically-definite~     relapsing-remittent MS who were registered through the Isfahan MS association volunteered for~     this study. They randomly selected an aquatic exercise (n = 17) and control (n = 15) groups.~     Aquatic exercise group completed a 8-week aquatic exercise training program consisted of~     three sessions per week, each session lasting 45 to 60 minutes 50 to 75 percent of their~     maximum heart rate reserve on 20-25 degree centigrade's, whereas the control group was~     instructed to maintain their current lifestyle. The balance of angry was surveyed with using~     of Berg analyze, speed and endurance 6 minutes walking test before starting of exercise~     program and after 4 weeks and at the end of 8 weeks was analyzed. The obtained data's were~     analyzed using analysis of variance with repeated measures.~   "
52273|NCT02882711|"~     The primary objective of this study is to determine the effectiveness of serial infusions of~     intravenous (IV) ketamine in adults with treatment resistant depression (TRD).~   "
52274|NCT02882698|"~     The game Marble Maze Classic® will be used, in which the participants have to move the mobile~     phone to conduct a virtual marble through a maze design. The investigators will evaluate 100~     individuals (50 with Down Syndrome-DS and 50 with typical development-TD) and divide both~     with DS and TD into group 1 and 2, where each group consists of 25 participants, with group 2~     using a maze design totally opposite to group 1.~   "
52275|NCT02882685|"~     This study compares Roux-en-Y gastric bypass with single anastomosis gastric bypass in a~     randomized prospective setting. This study also adresses the issue of bile reflux after MGB.~   "
52287|NCT02882529|"~     NOTE: This is the second of in total 7 sub-studies related to the Ethics Committee of the~     Canton of Bern Ref. No. KEK-BE 2016-00674. This sub-study includes 50 participants and 6~     arms, in total 350 participants will be assessed in all 7 sub-studies.~      General study information: This is a randomized, cross-over, quantitative study, which~     investigates physiological variables, mood, and affect of healthy participants in response to~     colored light exposure. The Participants take part in 5-8 arms and are exposed to colored~     light only, or are additionally asked to solve cognitive tasks during the colored light~     exposure. Primary aim is to measure the change in several physiological variables, mood, and~     affect during colored light exposure of 15 or 45 minutes. The risk for the participants is~     negligible and comparable to the risk during daily life.~   "
52276|NCT02882672|"~     This study aimed to determine if eight-weeks of exercise-based cardiac rehabilitation could~     improve adiponectin and cardiovascular disease risk factors in overweight coronary heart~     disease patients. Patients were included in the study if: they were approved to do so~     following a physical, physiological and psychological test; did not take part in regular~     physical activity; had stable heart failure for at least 3 months. Exclusion criteria~     included: a history of surgery within the preceding 4 months; had an unstable angina, acute~     phase of myocardial infarction, and/or unstable arrhythmia; had obstructive cardiomyopathy,~     exercise-induced ischemia or arrhythmias, uncontrolled arrhythmias, resting blood pressure~     more than 200/120 millimeters mercury, aortic stenosis, and/or peripheral artery disease;~     exercise limitations due to neuromuscular and/or musculoskeletal disease; had any health~     problems that prevented maximum effort on the treadmill test. Target population included of~     all patients with a history of myocardial infarction and diagnosis of congestive heart~     failure who were referred to Isfahan Cardiovascular Research Centre. 60overweight coronary~     heart disease patients were randomly assigned to either an eight-week, three times weekly~     exercise group (n=30), or a non-exercising control group (n=30). Exercise sessions took place~     at 60-85% of maximal heart rate, lasted 45-60 minutes and included a 10-minute warm-up, 40~     minutes of aerobic exercises, consisting of stationary cycling, walking and/or jogging,~     flexibility, balance exercises, and weight-bearing activity and a 10-minute cool-down.~   "
52277|NCT02882659|"~     The primary objective of this study is to evaluate the safety of autologous dendritic killer~     cell (DKC) in patients with metastatic solid tumor and to evaluate the maximum tolerated dose~     (MTD) of DKC. The primary endpoint of safety evaluation includes physical examination,~     assessment of vital sign, laboratory test, concomitant medication, and adverse event (AE).~     The secondary endpoints regarding efficacy includes the generation of tumor specific immune~     response by detecting CD3+ CD8+ CD69+ IFN-gamma+ T cells, and the improvement of quality of~     life~   "
52278|NCT02882646|"~     In stroke rehabilitation, unilateral training of the impaired limb after stroke is often the~     frequent strategy used over bilateral ones. However, the clinical need for bilateral training~     is supported by evidence that shows that unilateral training of the impaired limb does not~     automatically restore bimanual coordination and function. Increased focused is needed on~     developing more robot-assisted therapy that can train the impaired arm bilaterally and~     unilaterally. Controlling these robots is often difficult and requires a better understanding~     of the coupling effects of the left and right hand before and after a stroke. There is a need~     to develop robot-assisted therapy devices that can address coupled and uncoupled bimanual~     movements as well as symmetry as well as asymmetry in context of human bimanual actions along~     with the intermanual division of labor in various ADL tasks. This study focuses on bilateral~     training and the use of bio-inspired control algorithms to understand impairment and recovery~     on Bimanual Activities of Daily Living (ADLs) by stroke subjects in terms of the arm~     kinematics. Healthy subjects and those with hemiplegia due to a stroke or cerebral palsy will~     be evaluated by a member of the research team and asked to perform a battery of tasks to test~     the viability and usability of a bilateral robot system called BiADLER, which allows patients~     to complete daily tasks with varying levels of assistance to adapt task performance to each~     individual subject's performance. Subjects will to provide feedback to the researchers on~     their observations and thoughts about the therapy devices.~   "
52279|NCT02882633|"~     The purpose of this study is to compare lumbar plexus block to fascia iliac block done in~     adult patients who have undergone hip arthroscopy surgery. Visual analogue scores, opioid~     consumption, and quality of recovery 48 hours post operatively will be used for comparison.~   "
52280|NCT02882620|"~     Recent improvements in colorectal cancer (CRC) incidence, mortality, stage at diagnosis, and~     survival in the general U.S. population have been attributed to routine screening with prompt~     removal of polyps, early detection, and timely and appropriate treatment. American~     Indians/Alaska Natives (AI/ANs) have not experienced improvements in CRC related outcomes and~     are significantly less likely than non-Hispanic Whites to receive recommended CRC screening.~     The purpose of this three-arm randomized controlled trial is to determine the efficacy of~     interventions designed to enhance CRC screening. The study also uses mixed methods to~     finalize the intervention and to determine promoters and barriers of screening. The study~     also conducts process evaluation to determine cost-effectiveness of the interventions,~     fidelity of study implementation, and to develop plans to sustain and scale-up the~     intervention model. The study will determine the efficacy of serially implemented~     interventions of graded intensity for increasing CRC screening using the fecal immunochemical~     test (FIT) in accordance to recommended guidelines among average risk American Indians (AIs)~     aged 50-75 residing on reservations in rural Southwestern U.S. Serial implementation refers~     to offering routine screening, irrespective of response to an earlier invitation, in~     concordance with guidelines which recommend annual FIT testing between ages 50-75. The FIT is~     most appropriate because it is an approved, high sensitivity fecal occult blood test and is~     available at Indian Health Service (IHS) and tribal health facilities where resources to~     provide screening colonoscopy are limited. The study is a collaborative effort between the~     Albuquerque Area Indian Health Board (100% Indian-owned and operated), six Pueblo Tribes in~     rural Southwestern U.S., and the University of New Mexico. Findings from this research could~     lead to an immediate increase in CRC screening and ultimately reduce CRC burden among AIs,~     thus addressing national and tribal priorities of reducing CRC disparities among AIs.~   "
52281|NCT02882607|"~     The purpose of this study is to test the efficacy of an innovative, culturally relevant,~     community-based peer group intervention to increase young rural Malawian women's~     preconception behaviors to optimize their reproductive health. The study uses a longitudinal,~     two group (two-arm) design with a delayed control group.~   "
52282|NCT02882594|"~     The overall objective of the study is to improve the experience for pediatric patients~     undergoing anesthesia inductions. The specific objective for this proposal is to establish~     whether the CIBA tool demonstrates inter-rater reliability and concurrent validity with the~     Induction Compliance Checklist.~   "
52283|NCT02882581|"~     The general purpose of the trial is to investigate whether metformin is taken up into the~     breast tumor. Studies in the last few years have shown an effect of metformin on cell~     proliferation on breast cancer. It is though unclear whether the effect on tumor is direct,~     indirect or a combination of the two. The investigators plan to:~        -  investigate if metformin is taken up in breast cancer using our novel 11C-metformin~          tracer and positron emission tomography (PET)~        -  investigate whether the uptake is correlated to the amounts of organic cation~          transporters (OCT1-3, MATE 1 &2 and PMAT) using quantitive polymerase chain reaction~          (qPCR).~   "
52284|NCT02882568|"~     Improve knowledge of the immune response to sepsis in obese patients. Define immunological~     and genetic prognostic factors of severe infections which can motivate a change in the~     therapeutic attitude~   "
89630|NCT02393937|"~     The purpose of this study is to compare the efficacy of two Metronidazole Gels 1%, in the~     treatment of Rosacea.~   "
52288|NCT02882516|"~     NOTE: This is the first of in total 7 sub-studies related to the Ethics Committee of the~     Canton of Bern Ref. No. KEK-BE 2016-00674. This sub-study includes 50 participants and 5~     arms, in total 350 participants will be assessed in all 7 sub-studies.~      General study information: This is a randomized, cross-over, quantitative study, which~     investigates physiological variables, mood, and affect of healthy participants in response to~     colored light exposure. The Participants take part in 5-8 arms and are exposed to colored~     light only, or are additionally asked to solve cognitive tasks during the colored light~     exposure. Primary aim is to measure the change in several physiological variables, mood, and~     affect during colored light exposure of 15 or 45 minutes. The risk for the participants is~     negligible and comparable to the risk during daily life.~   "
52289|NCT02882503|"~     Incidental pancreatic solid or cystic lesions are diagnosed with increased frequency due to~     the widespread use of abdominal cross-sectional imaging to investigate unrelated symptoms.~     Lesions such as neuroendocrine tumors (NET), mucinous cystadenomas and intraductal papillary~     mucinous neoplasms (IPMNs) have the potential of malignant transformation. The standard~     treatment of solid or cystic pancreatic lesions with malignant potential has been surgical~     resection, with lesions in the pancreatic head requiring a Whipple resection whereas~     pancreatic tail lesions are treated with distal pancreatectomy. Both types of resection carry~     significant morbidity and mortality. The study would like to outline the feasibility, safety,~     adverse events and early results of endoscopic ultrasound (EUS) - radiofrequency ablation~     (RFA) in pancreatic neoplasms.~   "
52290|NCT02882490|"~     This is a randomized controlled trial to assess the efficacy of a parent training program to~     control disruptive behaviors in children with Tourette Syndrome.~   "
52291|NCT02882477|"~     Patients who are genetically diagnosed with the recently reported and rare Wolfram syndrome~     type 2 ( WFS2) and have the degenerative and symptomatic disease including signs such as~     diabetes, platelet aggregation defect or visual problems will be asked to participate in this~     study. Knowing the pathomechanism of WFS2 with rapid cell death, after doing baseline~     investigations to asses the severity of their disease, the participants will be offered a~     chelator therapy with in addition to the antioxidant Acetylcystein, in diabetic patients an~     Incertin (GLP-1 ) therapy will be offered as well. The baseline investigations will be~     repeated after 2 months and after 5 months of therapy in order to asses the progression of~     the disease and to show if the chelator and anti oxidant therapy and in diabetic patients the~     GLP-1 therapy could stop the progression of the disease.~   "
52292|NCT02882464|"~     Miller Class I Gingival Recessions (GR) have been treated by using Coronally Advanced Flap~     (CAF) with Platelet Rich Fibrin membrane (PRF membrane) or Connective Tissue Graft (CTG). The~     aim of this study was to evaluate the effect of different multiple layers of PRF membranes~     for the treatment of GR and compare the results with CTG procedure.~   "
52293|NCT02882451|"~     Pinaverium bromide can be used to treat symptoms related to irritable bowel syndrome (IBS)~     and functional disorders of the biliary tract. In this study, pinaverium bromide was compared~     with Vitamin C for the facilitation of bile duct and pancreatic duct cannulation in patients.~     The primary outcome was successful deep bile duct cannulation and pancreatic duct canulation.~     The second outcome was the major papillary orifice,bile juice flow from the papilla, time to~     achieve deep bile duct cannulation, fluoroscopy time for deep bile duct cannulation,the~     appearance of the major and minor papillary orifice, pancreatic juice flow from the papilla,~     time to achieve deep pancreatic duct cannulation, and fluoroscopy time for deep pancreatic~     duct cannulation in the pinaverium bromide group versus Vitamin C group.~   "
52294|NCT02882438|"~     Tinea Pedis infected the feet of about 20-25% of the world population. Tinea Pedis is a~     fungal infection of the feet and it is easily spread. Oral therapy is usually used for~     chronic conditions or when topical treatment has failed. The aim of this study is to prove~     the antifungal and antibacterial activity of Ginko Biloba (GKB) & Glucosamine (GL) as~     separate material or both in combination.~   "
52295|NCT02882425|"~     The primary purpose of this phase 1 study is to investigate the absolute bio-availability of~     a single oral dose of selexipag, i.e., to assess the amount of selexipag which reaches the~     blood when administered as an oral tablet (ACT-293987) compared to an intravenous~     administration in healthy subjects.~   "
52296|NCT02882412|"~     Long-term use of opioids for chronic pain is a growing health and social problem, mainly~     because of the risk of dependence. Buprenorphine/naloxone is used as substitution therapy for~     opioid dependence. This substitution therapy in patients with opioid dependence lessens~     withdrawal symptoms and craving. There is limited research on the effectiveness of~     buprenorphine/naloxone in patients with chronic pain and iatrogenic opioid dependence. The~     primary aim of this study is to investigate the effectiveness of buprenorphine/naloxone in~     patients suffering from chronic pain and an iatrogenic induced dependence on opioids. This~     study will investigate the effects of opioid substitution by buprenorphine/naloxone in~     patients suffering from chronic pain using long-term opioids, with pain and withdrawal~     symptoms as primary outcome measures. Secondary outcome measures will be craving, substance~     use, psychiatric comorbidity and quality of life.~   "
52297|NCT02882399|"~     The pubic and abdominal pathology is common among athletes. It leads to a shutdown of~     physical activity for several months, and requires rehabilitative care, or surgery for a~     permanent cure. Shortystrap is designed to avoid surgery and allow the continuation of~     sports.~   "
52298|NCT02882386|"~     The aim of this study is to investigate the amino acid kinetics in blood after a bout of~     strength training and ingestion of different milk protein supplements (native whey, whey~     protein concentrate 80, hydrolysed whey, microparticulated whey and milk) The investigators~     hypothesize that native whey will give a faster and higher rise in blood concentrations of~     leucine compared to the other milk protein supplements.~   "
52308|NCT02882256|"~     Patients seen in the ED with either a laceration, minor head injury, or urinary tract~     infection will be randomized to one of two groups. Both groups will receive the standard~     written discharge instructions; in addition, one group will watch video discharge~     instructions. Each patient will be asked to complete a short survey with questions related to~     the discharge instructions received in the ED, and will be called 5-7 days after the ED visit~     to ask questions about discharge instructions and the ED visit.~   "
54583|NCT02852512|"~     The aim of the study is to perspectively compare the anatomical and functional outcomes of~     Pelvic Organ Prolapse (POP) repair after Laparoscopic or Robotic-assisted Colposacropexy.~   "
52299|NCT02882373|"~     The goal of this clinical research study is to learn if L-arginine can help control side~     effects of anti-cancer drugs such as high blood pressure, protein in the urine, and kidney~     problems. L-arginine is a nutritional supplement and will be compared to a placebo in this~     study.~      A placebo is not a drug. It looks like the study drug but is not designed to treat any~     disease or illness. It is designed to be compared with a study drug to learn if the study~     drug has any real effect.~      This is an investigational study. L-arginine is not FDA-approved for the treatment of a~     specific disease or condition. Its use in this study is investigational. The study doctor can~     explain how the study drug is designed to work.~      Up to 40 participants will be enrolled in this study. All will take part at MD Anderson.~   "
52300|NCT02882360|"~     Pregnant women with BMI>40 will be approached for participation in a study to reduce the rate~     of post-operative wound infection from C-section. Women will be randomized to a commonly used~     wound product (Kerlix-AMD) which consists of a PHMB-impregnated gauze versus normal gauze,~     and rates of post-operative surgical site infection will be assessed. Women with a planned~     procedure will also be randomized to applying Kerlix versus gauze for 3 days pre-operatively~     to determine if this improves outcomes as well.~   "
52301|NCT02882347|"~     Post hepatectomy liver failure (PHLF) is a serious medical problem could lead to patient~     death, however, definite treatment strategy has not been established. The liver is a~     regenerating organ and the possibility of PHLF could be reduced when the appropriate liver~     regeneration is guaranteed.~      Portal flow has known to be important during liver regeneration. Low portal flow cannot~     induce proper regeneration, contrary, excessive flow increase shear stress in the hepatic~     sinusoid resulting liver failure.~      Various medications has been used in malignant liver cirrhosis to reduce portal pressure.~     Among them, somatostatin has been used modulating portal flow reducing portal and sinusoidal~     pressure.~      In this study, the investigators administrate somatostatin at a rate of 3.5ug/kg/hour to PHLF~     patients (prothrombin time < 50% and serum total bilirubin > 2.9mg/dl after liver resection)~     until recovery from liver failure. For assessment of the recovery of liver failure, the~     investigators evaluate aspartate transaminase (AST), alanine transaminase (ALT), serum total~     bilirubin and prothrombin time periodically after administration of medication.~   "
52302|NCT02882334|"~     Writer's cramp (WC) is a focal dystonia characterized by abnormal movements and postures~     during writing. Limited finger independence during writing manifests as difficulty~     suppressing unwanted activations of neighbouring non task-relevant fingers. WC patients also~     have difficulty in fine control of grip force. However, some previous studies indicate~     positive effects of individual finger movement training in WC although these studies lacked~     enhanced visual feedback of activations in 'stationary' fingers. The investigators have~     recently developed the Finger Force Manipulandum which quantifies the forces applied by the~     fingers in different tasks. This method is sensitive for detection and quantification of~     small unwanted contractions in non-active ('stationary') fingers. Forces in 'stationary'~     fingers can be displayed on-line providing enhanced feedback on independence of finger~     movements. The aim of this study is to test the effectiveness of finger individuation~     training using the FFM to improve symptoms in WC patients.~   "
52303|NCT02882321|"~     This clinical research study has 2 parts: dose escalation and dose expansion.~      The goal of dose escalation in this clinical research study is to find the best dose of~     IACS-010759 that can be given to patients with relapsed or refractory AML.~      The goal of dose expansion in this clinical research study is to learn if the dose of~     IACS-010759 found in the dose escalation part of the study is the best dose to use in future~     studies using IACS-010759 in patients with AML.~      The safety and tolerability of this drug will also be studied.~      This is the first study using IACS-010759 in humans.~      This is an investigational study. IACS-010759 is not FDA approved or commercially available.~     It is currently being used for research purposes only. The study doctor can explain how the~     study drug is designed to work.~      Up to 48 participants will take part in this study. All will be enrolled at MD Anderson.~   "
52304|NCT02882308|"~     OPHELIA (OlaParib in patients with HEad and neck squamous-celL carcInomA) trial is a Greek,~     investigator-initiated, randomized open-label window-of-opportunity phase II study. Patients~     with operable histologically documented squamous-cell carcinoma of the oral cavity,~     oropharynx, hypopharynx or larynx will be randomized between combination with cisplatin and~     olaparib, monotherapy with olaparib or no treatment, before standard treatment.~   "
52305|NCT02882295|"~     Writer's cramp (WC) is a task specific dystonia that occurs from the moment patient starts~     writing. It leads to partial or complete inability to use the hand only during the~     handwriting gesture. It is characterized by the appearance of cramps or spasms of certain~     muscles of the hand and/or forearm.~      Clinical scales currently use for the assessment of WC fail to accurately reflect changes in~     the characteristics of handwriting in response to treatments (Botulinum Neurotoxin injections~     and / or retraining therapy).~      The Zigzag Tracking Task (ZZTT), easy to use in current practice provides useful information~     in terms of speed and precision of handwriting gesture. This timed handwriting test is to~     follow with a pen a zigzag path beset with obstacles to avoid. It permits to evaluate the~     time in seconds required to carry out the zigzag path and count the number of errors (output~     path and contacts with obstacles). The investigators propose to validate the ZZTT for the~     assessment of the handwriting gesture of WC.~   "
52306|NCT02882282|"~     The goal of this clinical research study is to compare pembrolizumab to standard of care~     observation (no treatment) in controlling oral pre-malignant lesions and IENs. The safety and~     tolerability of pembrolizumab will also be studied.~      This is an investigational study. Pembrolizumab is FDA approved and commercially available~     for the treatment of certain types of melanoma and non-small cell lung cancer (NSCLC). It is~     currently being used for research purposes in head and neck cancer. The study doctor can~     explain how the study drug is designed to work.~      Up to 250 people will be enrolled in this study. All will take part at MD Anderson.~   "
52307|NCT02882269|"~     A randomized controlled clinical trial to compare the short and long outcomes of Neoadjuvant~     chemotherapy with postoperative chemotherapy in patients with resectable locally advanced~     colon cancer~   "
52319|NCT02882113|"~     This study is a multicenter, single-arm, open-label, 24 weeks, and investigator-initiated~     clinical trial to assess the influence of CYP3A5 polymorphism on liver function abnormality~     and the trough level change after conversion to Advagraf® in liver transplant recipients.~   "
52310|NCT02882230|"~     The frequency of neurological and psychiatric complaints for participants taking rilpivirine,~     elvitegravir, or dolutegravir reaches on average 20—30% during clinical trials. The inclusion~     and exclusion criteria for enrolling people living with HIV are at times so selective and the~     subsequent descriptions of minor or severe adverse events (AE's) so often imprecise and~     ambiguous that one cannot extrapolate these particular research results to practicing~     medicine. These adverse events negatively affect the patient's quality of life and ultimately~     his or her good adherence to treatments.~      This study aims at assessing the prevalence and at describing the neurological and~     psychiatric adverse events related to these drugs.~   "
52311|NCT02882217|"~     The study focusses on the evaluation of safety and tolerability of the XC8. The design of the~     study involves sequential dosing of cohorts (group of volunteers), taking increasing doses of~     the product after receiving conclusion and recommendation for further continuation of the~     study from the Dose Escalation Committee.~   "
52312|NCT02882204|"~     The investigators propose to study the brain processes that result in thought and language~     disorder and influence outcomes seen in patients with schizophrenia using a combination of~     brain scans and clinical assessments. The project will assess patients at various stages of~     psychosis (first episode and chronic stage >3 years of illness) referred to the Prevention~     and Early Intervention in Psychosis Programme using Magnetic Resonance Imaging (MRI scans).~     To track the outcome of this illness, investigators will follow-up patients over 3 years and~     collect MRI scans over four sessions for each patient. Participants will also complete a~     clinical assessment examining symptoms and functioning as per the current clinical practice~     within the PEPP program.~   "
52313|NCT02882191|"~     To evaluate the effectiveness, device placement, safety, and tolerability of LevoCept to~     support commencing a Phase III Clinical Study~   "
52314|NCT02882178|"~     Cabazitaxel is a second line chemotherapy drug recently approved for the treatment of~     metastatic castration-resistant prostate cancer. To investigate whether the precautions for~     the use of cabazitaxel (contraindications, hepatic function, premedication for~     hypersensitivity, prophylactic treatments, dose and dose adjustment, as well as conditions of~     administration) are respected in routine practice, an observational cohort study will be~     implemented in 32 oncology centres of South-West region of France (CABOBS study). The primary~     objective of this cohort is to evaluate the conformity of cabazitaxel prescriptions with the~     Summary of Product haracteristics (SPC) in clinical practice (indications and monitoring~     methods) and according to the conditions of use. Panel of experts were convened to assess the~     conformity of prescription of cabazitaxel with a Delphi consensus method. The Delphi method~     is most suited to areas where a limited number of evidences are available to enable a~     recommendation or guidelines to be drawn. Moreover, all the evaluated items came from an~     official document provided by the EMA, the SPC of cabazitaxel. Thus, it is expected from the~     experts to select the most relevant items. In the frame of the CABOBS study, this method will~     allow to select items of the SPC list according to their importance, and to define the~     primary objective of conformity to cabazitaxel conditions of use.~   "
52315|NCT02882165|"~     Chronic Obstructive Pulmonary Disease (COPD) is a condition resulting from environmentally~     induced lung damage e.g. cigarette smoking and air pollution which, over time, causes~     individuals to suffer from symptoms including chronic cough and progressive breathlessness.~     In the UK COPD is predominantly caused by cigarette smoking which may have occurred decades~     before the symptoms appear and the disease is diagnosed.~      The aim of this study is to identify those COPD patients who currently have milder disease~     and to investigate whether a detailed, medical assessment which has time to assess all~     aspects of their care will improve their lung health and general wellbeing.~      COPD is a major cause of disability and death in the UK, with around 835,000 people currently~     diagnosed with the disease and an estimated further two million people who suffer from~     symptoms but do not yet have a diagnosis(1). Approximately 25,000 people each year die from~     COPD in England and Wales (2), with the disease accounting for 5.4% of all deaths in England~     and Wales in 2013 (3). Predominantly in its later, more severe stages, COPD causes an~     enormous symptom burden to patients, and accounts for up to half of emergency admissions to~     already overstretched hospital services in England (4).~      People with COPD, with a past history of smoking, are at higher risk of other medical~     problems such as heart disease and stroke(5). Being breathless and having multiple physical~     health problems can also lead to mental health problems such as anxiety and depression(5).~     This means it can be challenging to provide this group of people enough time to fully assess~     and treat all their problems, particularly due to current pressure on the length of GP~     appointment times.~      Whilst COPD is treatable, it is not curable, and emphasis on early diagnosis and intervention~     provided a key part of the strategy for COPD published by NHS England in 2012(6). With early~     diagnosis, the opportunity is provided to intervene with the aim of improving symptoms and~     exercise tolerance, reducing the risk of exacerbations, slowing deterioration and prolonging~     quality of life.~   "
52316|NCT02882152|"~     Knee arthroplasty has a high potential for postoperative pain. This study compares analgesia~     and postoperative bleeding from intrathecal morphine with the continuous femoral and a~     single-shot sciatic nerve blockades.~   "
52317|NCT02882139|"~     Organized ventricular arrhythmias (ventricular tachycardia (VT), torsades de pointes (TdP)~     and ventricular fibrillation (VF)) represent a major event in the clinical history of a~     patient and they can lead to hemodynamic instability and sudden cardiac death (SCD).~     Recurrences of ventricular arrhythmias and electrical instability have exponentially~     increased in the last decades and a new clinical entity called electrical storm (ES) has~     emerged as major morbidity and mortality factor. The ES is defined as a cluster of 3 or more~     sustained ventricular arrhythmias within 24 hours, or a sustained ventricular tachycardia~     lasting 12 hours or more and that does not respond to treatments.~      Most of the patients presenting ES are already implanted with an ICD. This is due to 3~     factors: first, patients with ICD implant are at higher risk to develop ventricular~     arrhythmias for the cardiac disease that led to the ICD implant. Second, the device records~     and treats also asymptomatic or poor symptomatic arrhythmic episodes that otherwise would not~     be detected. Third, and more important, the device gives the possibility to survive to an~     arrhythmic episode, making it possible for the patient to experience an ES. The incidence of~     ES is debated in different studies and ranges from 10 to 60% in patients with ICD for~     secondary prevention and from 4 to 7% in patients with ICD for primary prevention.~      The aim of the ELECTRA registry is twofold:~        1. To create an international registry on clinical features, optimal therapy, ablation~          strategy, prognosis and the effect of ICD programming on patients with ES.~        2. To use the data derived from the registry for a prospective, observational study on~          mortality and rehospitalization rate in patients with ES.~   "
52434|NCT02880618|"~     The purpose of this registry is to evaluate the effect of BAROSTIM THERAPY with the BAROSTIM~     NEO System in the commercial setting in subjects recently implanted under the CE-Marked~     indication for heart failure with reduced ejection fraction (HFrEF).~   "
52321|NCT02882087|"~     This is a phase Ⅱ, placebo-controlled, multicenter, dynamic randomized, double blind study of~     the efficacy and safety of RC18, a recombinant human B lymphocyte stimulating factor~     receptor-antibody fusion protein in subjects with inadequate response of TNF-α antagonists~     due to treat moderate and severe rheumatoid arthritis.~   "
52322|NCT02882074|"~     The purpose of this study is to evaluate whether patients receiving human albumin for plasma~     volume replacement during cardiac surgery have improved postoperative endothelial function~     compared to patients receiving 6% hydroxyethyl starch solutions. The postoperative~     endothelial function, measured with peripheral arterial tonometry as reactive hyperemia index~     (RHI) within 2 hours following surgery, will be compared in cardiac surgical patients~     randomized to receive human albumin or 6% HES solutions for intraoperative volume~     replacement. Within two hours of arrival to the ICU peripheral arterial tonometry using~     EndoPAT will be performed. In a subset of 40 consecutive patients the investigators will~     perform additional EndoPAT measurements to describe the expected changes that occur in~     endothelial function during the perioperative period (baseline, early postoperative and 24~     hours postoperative) using RHI.~      This study will also determine whether human albumin 5% reduces plasma biomarkers of~     endothelial and glycocalyceal damage by measuring plasma concentrations of syndecan 1 and~     endocan at baseline (before surgery), and 1 and 24 hours following surgery. Blood samples~     will be taken on the morning of the surgery, within one hour of arrival to the intensive care~     unit (ICU), and 24 hours after surgery or within 2 hours before discharge from the ICU (three~     times altogether). These samples will be used to measure the plasma concentrations of two~     biomarkers that measure endothelial injury.~   "
52323|NCT02882061|"~     Neck pain is a very common diagnosis and physical therapy, specifically thoracic~     manipulation, has been shown to be an effective treatment. Thoracic manipulation, which~     involves a quick thrust type push to a segment of the midback region of the spine, has been~     shown to decrease pain and improve function in individuals with neck pain. However, it is not~     known if there is a test that will accurately identify individuals with neck pain who would~     respond more favorably to thoracic techniques. The Cervical-Thoracic Differentiation Test~     (CTDT) is a test used clinically to differentiate pain originating from either the cervical~     (neck) or thoracic (midback) regions of the spine in individuals with neck pain. It has also~     been speculated that specific unloading tests, where a tester selectively unloads a portion~     of the weight of the cervical or thoracic spine through manual distraction may help determine~     who will respond more favorably to thoracic treatment. To the best of our knowledge, despite~     widespread clinical use, these tests have not been tested for validity or reliability at this~     time. Therefore, the purposes of this research are to assess the reliability and criterion~     referenced validity of the CTDT and unloading tests, as well as examine the relationship~     between tests and baseline subject characteristics.~   "
52324|NCT02882048|"~     This study is to compare two groups undergoing opioid weaning as ordered by their referring~     physicians. One group will undergo the standard opioid weaning process and the other group~     will have the addition of the NADA Protocol to the weaning process.~   "
52325|NCT02882035|"~     66 female patients undergoing breast cancer surgery were randomized in the Jules Bordet~     Institute, the Belgian oncology institute. One group received an opioid anesthesia, the other~     group an opioid free one. The hypothesis of this study was that opioid free anesthesia~     improves the postoperative quality of recovery of anesthesia.~   "
52326|NCT02882022|"~     This study is an investigation into the effect that CPAP has on the pressure in the middle~     ear. It will evaluate the middle ear pressure and ear drum appearance at multiple levels of~     CPAP pressure delivered via a full face mask. These measurements will be used to determine~     optimal levels of CPAP to affect individual's middle ear pressure, particularly those with~     negative middle ear pressure due to Eustachian tube dysfunction.~   "
52327|NCT02882009|"~     The purpose of this randomized, open-label, parallel-group, placebo-controlled study is to~     assess pain following subcutaneous (SC) administration of gantenerumab as a~     high-concentration liquid formulation (HCLF) at different injection speeds. The total~     duration of the study for each healthy participant will be up to approximately 21 weeks.~   "
52328|NCT02881996|"~     The objective of this study is to evaluate two standard post-operative pain regimens~     routinely used after laparoscopic appendectomy for perforated appendicitis. The investigators~     hypothesize that the use of intravenous (IV) acetaminophen in addition to IV ketorolac with~     narcotic pain pump will decrease time to transition off patient/nurse controlled analgesia~     (PCA) to oral pain medications.~   "
52329|NCT02881983|"~     Background:~      Difficulties in assigning and identifying emotional states, or to regulate the emotional~     costs are recognized as one of the major factors of relapse. This study aimed to evaluate the~     emotion regulation processes, in short term (STA, after 1month of withdrawal) and long-term~     alcohol abstinent individuals (LTA, at least six months of abstinence), compared to healthy~     control participants (C) in a positive and negative emotion induction protocol.~      Main aim:~      Evaluating the emotional regulation deficits assessed with physiological indicators (heart~     rate variability, electrodermal response, pupil diameter) and clinically in presentations of~     visual stimuli to emotional value (positive, negative, neutral) in alcohol use disorder's~     (AUD) patients with short and long term abstinent compared to a control group of healthy~     subjects. The investigators are particularly interested in the evolution of heart rate~     variability considered as a good marker of vulnerability to AUD.~      Secondary objectives:~      Studying the relationships between physiological measures and clinical variables such as~     behavioral indicators and self-reported assessment of cognitive and emotional skills among~     the three groups (STA, LTA and C).~   "
52330|NCT02881970|"~     Neonatal hypoxic-ischaemic encephalopathy is a dramatic perinatal complication due to brain~     asphyxia. Neurological and neurosensory sequelae are frequent in survivors, due to neuronal~     damage and loss.~      Currently, only total or partial body hypothermia can partially prevent cell loss. However,~     no treatment exists to restore neuronal functions.~      Cord blood stem cells are a promising treatment for the near future.~      The primary objective of this study is to test the safety and feasibility of a curative~     treatment with autologous cord blood stem cell in neonatal hypoxic-ischaemic encephalopathy.~      The secondary objectives are to test the efficacy of this curative treatment with cell with~     neurogenic potential on the prevention of neurologic sequelae, as well as to test the optimum~     timing of cell preparation administration~   "
52331|NCT02881957|"~     Vitamin D has been shown to impact prognosis in a variety of retrospective and randomized~     clinical trials within an intensive care unit (ICU) environment. Despite these findings,~     there have been no studies examining the impact of hypovitaminosis D in specialized~     neurocritical care units (NCCU). Given the often significant differences in the management of~     patients in NCCU and more generalized intensive care units there is a need for further~     inquiries into the impact of low vitamin D levels in this specific environment. This study~     proposes a randomized, double-blinded, placebo-controlled, single center evaluation of~     vitamin D supplementation in the emergent NCCU patient population. The primary outcome will~     involve length-of-stay for emergent neurocritical care patients. Various secondary outcomes,~     including in-hospital mortality, ICU length-of-stay, Glasgow Outcome Score on discharge,~     complications and quality-of-life metrics. Patients will be followed for 6 months~     post-discharge.~   "
52332|NCT02881944|"~     Fermentable Oligo-, Di and Mono-saccharides And Polyols (FODMAPs) are carbohydrates that are~     poorly digested in intestines. The undigested carbohydrates are fermented in the colon by gut~     bacteria. Fermentation of these carbohydrates can lead to diarrhea, gas and distension of the~     colon. Low FODMAP diet effect may be mediated by changing the gut bacteria and/or by~     production of chemicals that influence Veteran's intestines which then result in reduced~     disease symptoms.~      The goal of this study is to compare a low FODMAP (modified healthy) diet to a high FODMAP~     (typical healthy) diet for effect on Veterans with IBS and symptoms of Gulf War illness.~   "
52333|NCT02881931|"~     The FuRST 2.0 scale is being developed as a Patient Reported Outcome (PRO) with information~     coming directly from the Huntington's Disease Gene Expansion Carrier (HDGEC) and companion~     through self-report. The purpose of this study is to identify real or potential comprehension~     or usage problems with questionnaire items or response options. Through a process of~     structured cognitive de-briefing with HDGEC participants and companions, independently,~     followed by qualitative analysis, the final phrasing of the individual items and response~     options for the scale will be generated. Depending on the results of the first round of~     cognitive pre-testing, additional rounds of cognitive pre-testing may be required.~   "
52334|NCT02881918|"~     The purpose is the description of anti-tumor immune responses in general and according to~     clinical stage and disease free survival (DFS: survival without recurrence (local or~     distant)) in patients with Head & Neck Squamous Cell Carcinoma~      Secondary purposes are:~        -  Study of relationship between anti-tumor immune response and qualitative (yes/no) and~          quantitative (number) presence of circulating tumor cells (CTCs);~        -  Study of relationship between qualitative (yes/no) and quantitative (number) presence of~          CTCs and clinical stage as well as DFS~        -  Study of relationship between anti-tumor immune response and clinical stage as well as~          DFS.~   "
52335|NCT02881905|"~     There is a significant difference between CM LOC and ball attachment, when considering the~     peri-implant soft tissue health and marginal bone loss. The primary and secondary objectives~     are to determine if CM LOC attachment improves the peri-implant soft tissue response and~     decreases the marginal bone loss around implant when compared to conventional ball attachment~   "
52336|NCT02881892|"~     The aim of study was to evaluated the correlation between plasma levels, dialysate appearance~     rate of VEGF, inflammatory cytokines (IL- 6, procalcitonin) and PSTR, dialysis adequacy in~     CAPD patients.~   "
52337|NCT02881879|"~     The aim of the study is to evaluate the safety and tolerability of subcutaneous immunotherapy~     (SCIT) with House Dust Mite (HDM) extract in patients with rhinoconjunctivitis with or~     without associated mild asthma and sensitized to HDM. In addition,surrogate efficacy~     parameters will be evaluated: immunoglobulin level changes and skin reactivity.~      It will be recruited 50 patients susceptible to receive SCIT with HDM extract along 5~     participating spanish sites.~      Primary endpoint of the study is to assess the safety and tolerability of subcutaneous~     immunotherapy in depot presentation and quick pattern in patients with rhinoconjunctivitis~     with or without mild asthma sensitized to house dust mites~      Secondary objective is to evaluate the indirect immunotherapy efficacy through the~     measurement of immunoglobulin level changes and cutaneous reactivity~   "
52338|NCT02881866|"~     This study evaluates the effect of inhaled furosemide on different types of breathlessness~     relief in healthy volunteers. Each volunteer inhaled mists of either furosemide or a control~     substance on 3 occasions per day on 2 separate days. On one day they performed one~     breathlessness test which creates an 'urge to breathe' known as air hunger (AH) and the other~     day they performed a breathlessness test which increases the sense of work/effort (WE) of~     breathing. The study is double blinded so neither the volunteer or the research knows which~     mist is being inhaled.~   "
52339|NCT02881853|"~     This is a Phase 1b, combined multiple dose subcutaneous (SC) bioavailability (BA) and~     multiple ascending dose (MAD) study evaluating safety, tolerability and BA of SC XmAb7195 in~     healthy subjects and in subjects with atopic disease.~   "
52340|NCT02881840|"~     Open-label, non-randomised, single dose study in 6 healthy male subjects to assess the mass~     balance recovery, metabolite profile, metabolite identification and pharmacokinetics of~     14C-labelled APD421~   "
52341|NCT02881827|"~     The purpose of this study is to obtain experimental data on the possible changes that saliva~     may suffer when brought to low-level laser therapy protocols for analgesia in the masseter~     muscle, because this be on the Parotid salivary gland.~   "
52342|NCT02881814|"~     Introduction: Physiotherapist usually uses a clinical examination, including auscultation, an~     analysis of blood gasses and chest imaging to determine the indication for chest~     physiotherapy, to choose the treatment protocol and evaluate the efficacy of the management.~     Lung ultrasound (LUS) presents greater accuracy than chest X-ray in the diagnosis of lung~     deficiencies interesting the physiotherapist. So, it could allow the physiotherapist to~     determine the indication for chest physiotherapy and thus avoid unnecessary or inappropriate~     treatments. No study has evaluated the impact of LUS on clinical decisions in chest~     physiotherapy in ICU patients.~      Objective: To evaluate the impact of using the results of lung and diaphragm US on clinical~     decisions in chest physiotherapy in hypoxemic patients hospitalized in ICU.~      Method: The physiotherapist carries out a clinical examination and analyses the complementary~     tests (chest X-ray, chest CT-scan and blood gasses if available). Following the examination,~     he will put forward one or several hypotheses concerning the respiratory deficiency and will~     confirm or not the indication for chest physiotherapy. If respiratory physiotherapy is~     indicated, the physiotherapist will specify the protocol.~      A lung and diaphragm US will be done following the evaluation of the clinical~     physiotherapist, and will make it possible to answer the question: are the results of the~     lung and diaphragm US compatible with the hypotheses put forward? The LUS report will be~     given to the clinical physiotherapist. He will specify the respiratory physiotherapy protocol~     according to the results of the US-scan.~      The modification of the clinical decision will be assessed with the Net Reclassification~     Index (NRI).~      Expected results: We expect that decisions for chest physiotherapy will be modified by LUS.~     The expected benefit for patients is therefore that they will be given a chest physiotherapy~     protocol that is better suited to the type of respiratory deficiency they are suffering from.~   "
52343|NCT02881801|"~     This study aims to describe the pattern of active and sedentary time in survivors of a~     critical illness, at three time points during their hospital admission (awakening in the ICU~     after ≥ 5 days of mechanical ventilation, discharge to ward and discharge from hospital).~      The specific research objectives are to~        1. Determine the duration of active and sedentary parameters including time and bouts in 24~          hour periods~        2. Examine changes in the active and sedentary parameters including time and bouts between~          time points of awakening and both ICU and hospital discharge.~        3. Conduct a preliminary examination of relationships between activity and sedentary~          behaviour metrics with measures of muscle strength, physical function and hospital~          length of stay.~   "
52344|NCT02881788|"~     Minnesota Healthy Brain Initiative will be an ongoing project that aims to increase awareness~     regarding brain health and its maintenance as well as increasing awareness of the impact of~     alcohol on brain function. In the immediate future, we hope to obtain data from a non-injured~     normative, diverse population represented by the state fair patrons.~   "
52345|NCT02881775|"~     The purpose of the study is to identify things that influence the ability to turn on the~     thigh muscle (quadriceps). The thigh muscle tends to be under active with knee~     osteoarthritis, which may make it difficult to strengthen the muscle. The investigators are~     also testing a new technology called repetitive transcranial magnetic stimulation (rTMS) to~     determine whether it may help turn up activity in the under active thigh muscle immediately~     after its application. rTMS uses a targeted pulsed magnetic field, similar to what is used in~     an MRI (magnetic resonance imaging) machine to send an electrical signal from the brain to~     the thigh muscle.~   "
52346|NCT02881762|"~     This is a single-site, longitudinal, open-label, interventional study for evaluating the~     effect of maraviroc on hepatitis C viral levels in patients infected with both hepatitis C~     and human immunodeficiency virus (HIV) and taking antiretroviral therapy for HIV.~   "
52347|NCT02881749|"~     The clinical efficacy of mechlorethamine gel (Valchlor) as a maintenance therapy after low~     dose total skin electron beam therapy (TSEBT) for the treatment mycosis fungoides cutaneous~     T-cell lymphoma will be evaluated in this study. Subjects will be treated with low dose TSEBT~     (12 Gy total) over a period of two weeks. After a 30 day observation period and confirmation~     that their disease stage has been downgraded to IA or IB, subjects will use Valchlor as a~     maintenance therapy over the course of one year. The efficacy of Valchlor as a maintenance~     drug will be followed clinically through Modified Severity Weight Assessment Tool (mSWAT) and~     percent body surface area measurements (%BSA). Furthermore, subjects will be followed~     histopathologically through skin biopsies performed at the screening visit, immediately after~     observation period, one month after the start of the maintenance period, and twelve months~     after the start of the maintenance period (4 biopsies total).~   "
52348|NCT02881736|"~     Clinical assessment of motor and sensory deficits is still today largely based on tests that~     do not permit any precise quantification. However, robotic technologies, coupled with~     neuroimaging techniques constitute new tools to assess sensorimotor functions that could~     allow to conceive neurorehabilitation protocols better adapted to the neurological impairment~     of each patient and to her/his specific recovery profile.~      The goal of this project is to contribute identifying the factors that determine functional~     recovery in stroke patients presenting upper-limb motor deficits. Here, we will focus our~     research on two factors that contribute in a complementary way to motor control: 1) the~     processing of proprioceptive informations, and 2) the processing of movement-execution~     errors. In this purpose, we will combine psychophysical methods that allow to precisely~     quantify sensorimotor deficits with functional and anatomical neuroimaging techniques. More~     specifically, we will exploit experimental protocols that have been developed in basic~     research, that use a robotic exoskeleton coupled with a virtual reality device, to precisely~     quantify motor and proprioceptive deficits in stroke patients. Then, we will link these~     behavioral data to electroencephalographic (EEG) signals recorded during a motor adaptation~     task, as well as to anatomical data, namely conventional magnetic resonance imaging (MRI)~     completed by diffusion tensor images (DTI) in order to achieve a finer description of the~     cerebral lesions.~      The present study will include two experimental parts, respectively centered on the~     proprioceptive deficits (Part 1) and the anomalies in the processing of movement-execution~     errors (Part 2).~      Proprioceptive deficits in stroke patients : We will test the hypothesis that, when present,~     deficits in kinaesthesia and troubles in unconscious proprioception contribute substantially~     to motor deficits in stroke patients ; with as a corollary hypothesis, that deficits in ~     proprioception for action  are more determinant than deficits in the conscious sense of~     position (classically tested in clinics). In this purpose, we will collect three sets of~     behavioral data, in chronic stroke patients and healthy control participants, respectively~     intended to assess a) motor deficits, b) troubles in conscious sense of position, and c)~     deficits in proprioception for action. To better document the neuronatomical substrates of~     these different types of deficits. In this purpose, we will link the obtained behavioral data~     with the results of detailed analyses of the lesions of the tested stroke patients.~      Anomalies in the processing of movement-execution errors in stroke patients : We will assess~     movement-execution error processing in stroke patients, in order to test the idea that~     anomalies in error processing might contribute to motor deficits in stroke patients. In this~     purpose, we will record an electrophysiological correlate (ERP) of movement-error processing~     during a motor adaptation task. We will analyse the relation between the modulation of this~     ERP and motor performance. We will also examine the relation between these two sets of data~     (behavioral and electrophysiological) and the behavioral data collected during the first part~     of the study (Proprioceptive deficits). This will provide us with insight into the~     relationship between proprioceptive deficits and cinematic error processing. As in the first~     part of the study, we will link the observed electrophysiological and behavioral anomalies~     with the results of a detailed analysis of the anatomical lesions of the tested patients.~   "
52349|NCT02881723|"~     The level of knowledge about the consequences of oropharyngeal cancer treatment on sleep~     quality remains poor. Because of a high level of risk of developing an Obstructive Sleep~     Apnea Syndrome (OSAS), an accurate evaluation of the prevalence, of the risk factors and of~     the impact on quality of life is important in order to propose preventive and therapeutic~     solutions to these patients.~   "
52350|NCT02881710|"~     Multicenter, prospective, uncontrolled study to evaluate variations in urinary concentrations~     of TIMP-2 and PCI IGFBP7 induced injection during a CT scan in intensive care patient.~   "
52351|NCT02881697|"~     The target of rapamycin complex 2 (TORC2) is an evolutionarily conserved serine/threonine~     protein kinase that controls growth and metabolism. In mammals (including humans), mammalian~     TOR complex 2(mTORC2) contains mammalian TOR (mTOR), RICTOR, mSIN1 protein, and mLST8 gene.~     In an animal model, the adipose-specific rictor knockout (AdRiKO) mouse, systemic insulin~     resistance, hepatic steatosis, and cardiovascular dysfunction develop upon high fat diet~     (HFD)-induced obesity or aging. To find a molecular link between adipose mTORC2 and systemic~     insulin resistance, investigators have already performed transcriptomics and proteomics~     analysis on visceral white adipose tissue in a mouse model. The aim of the study is to~     confirm a molecular link between adipose mTORC2 and systemic insulin resistance in humans.~   "
52352|NCT02881684|"~     This research project will provide insight into the efficacy and safety of aspiration therapy~     in the management of obesity and its comorbidities in the Asian population, and will~     determine if there is a role for this novel endoscopic device in the treatment algorithm of~     obesity in the investigators' local regions.~   "
52353|NCT02881671|"~     Identification of genes involved in congenital atrioventricular block and progressive Cardiac~     Conduction Disease.~   "
52843|NCT02875275|"~     This study examines the metabolic effects of 3 possible test meals (Oleogel) and/or 3~     possible test meals (Grass Jelly). The participants will have the option to voluntarily~     choose which study part(s) to participate. This study will be evaluated on 40 healthy Chinese~     male subjects from the general public over a period of one year.~   "
52354|NCT02881658|"~     This is a local, single-center, two-arm, randomized, double-blind, placebo-controlled~     clinical trial that examines the LDL-C-lowering effect of the consumption of a soya beverage~     enriched with plant sterol for 3 weeks. This study also examines if there is other~     health-benefits by consuming the plant sterols fortified soya beverage in terms of serum~     total triglyceride, total and HDL cholesterol, other cardiometabolic risk factors and~     musculoskeletal-related traits including handgrip strength, gait speed, peak expiratory flow~     rate, bio-impedance and body balance.~   "
52355|NCT02881645|"~     The purpose of this study is to assess the effectiveness of a best practices nursing protocol~     in intensive care units on the occurrence of critical incidents compared to the common~     practices.~   "
52356|NCT02881632|"~     A cohort observational study to characterise baseline Structured Light Plethysmography (SLP)~     outputs in infants with bronchiolitis and examine response to treatment using the Thora3DiTM~   "
52357|NCT02881619|"~     Objectives: This study will determine the effectiveness of preemptive administration of~     etodolac on risk and intensity of tooth sensitivity caused by in-office bleaching using 35%~     hydrogen peroxide.~      Materials and Methods: Fifty patients will be selected for this triple-blind, randomized,~     cross-over, placebo-controlled clinical trial. Etodolac (400 mg) or placebo will be~     administrated in a single-dose 1 hour prior to bleaching procedure. The whitening treatment~     with 35% hydrogen peroxide will be carried out in two sessions with a 7-day interval. Tooth~     sensitivity will be assessed before, during and 24 hours after the procedure using analog~     visual and verbal scales. Color alteration will be assessed by a bleach guide scale 7 days~     after each session. Relative risk to sensitivity will be calculated and adjusted by session;~     while comparison of overall risk will performed by McNemar's test. Data on the sensitivity~     level for both scales and color shade will be subjected to the Friedman, Wilcoxon and~     Mann-Whitney tests, respectively (α = 0.05).~   "
52358|NCT02881606|"~     Bilateral cleft lip and palate neonates will be randomly assigned to one of two groups: (gp1~     presurgical Naso-alveolar molding (NAM) using Grayson method, gp 2 computer aided design NAM~     (CAD/NAM). The aim of the study is to compare between short term clinical effects of both~     interventions as regards alveolar alignment, nasal esthetics and interlabial gap.~   "
52359|NCT02881593|"~     For twenty years, as for other surgical disciplines, new minimally invasive techniques have~     been developed with the main goal the reduction of muscle trauma associated with the~     surrounding roads classic and reduce morbidity linked to this one.~      More recently, minimally invasive methods dedicated to spinal surgery were established, for~     the treatment of herniated discs initially, then for narrow lumbar canals.~      The canal release on minimally invasive fusion, using a tubular system for muscle retraction~     is a new technique that has proven effective: post operative pain reduction of hospital stay~     and blood loss.~      The objective of the study is to investigate the quality of ductal release in these minimally~     invasive fusions.~      Main objective of the study: Evaluation of the quality of the release of post scanners~     operative minimally invasive arthrodesis~      Secondary Objectives: Assessment rates/types of early complications of technical Minimally~     invasive - early postoperative results (postoperative pain, analgesic consumption, length of~     hospital stay, blood loss) - in clinical outcomes in the short and medium term decompression~     after minimally invasive fusion.~   "
52360|NCT02881580|"~     The surgical management of spinal deformities especially in adults is complex. The~     conventional surgical treatment of these deformations is a scope arthrodesis of the spine.~     The quality of the result depends on many variables such as the choice of the vertebrae to~     fuse, location and the number of implants, the type of material used or the type of~     correction maneuver used.~      All these variables affect the surgical outcome and may be involved as a modifiable risk~     factor for possible postoperative complications. The study proposes to focus on the~     junctional kyphosis postoperative proximal (CJP or Proximal Junctional Kyphosis: PJK) 1.~     Their prevalence in adults ranges from 20% to 43% depending on the series (Yang and Cheng,~     2003; Yagi, King and al.2012).~      The radiographic definition of CJP's kyphosis with an angle> 10 ° measured from the lower~     plate of the proximal instrumented vertebra to the upper plate of the adjacent vertebra~     proximal not instrumented (Glattes and al.2005) 4; this measure is being compared to the pre~     operative data.~      Either the CJP are asymptomatic and do not require revision surgery (Yagi King and al.2011) 5~     either they are and thereby generate a revision surgery (Kim Bridwell and al.2008; Watanabe~     Lenke and al.2010) .~      Several factors may potentially influence the development of the CJP. Among them, age,~     preoperative comorbidities, obesity, osteoporosis, lesions of the posterior elements, hybrid~     instrumentation, correction forces applied during surgery, sagittal balance pre and post~     operative degeneration joint capsules, etc. There are few studies on the identification and~     analysis of these risk factors; literature gives only single-center studies on small samples~     10 with a single surgical procedure. Review articles describe the incidence and risk factors~     of the CJP. However, the pathophysiological mechanisms of the CJP are still controversial to~     this day.~      The aim of this study is to determine the incidence of occurrence of postoperative kyphosis~     proximal junctional and identify risk factors for developing this major complication of a~     multicenter population of scoliosis operated an extensive fusion.~   "
52361|NCT02881567|"~     The primary objective of the study is to evaluate the effects of treatment with daclizumab on~     the proportion of participants relapse-free at 6 months in Relapsing-Remitting Multiple~     Sclerosis (RRMS) participants, who switched from treatment with natalizumab to daclizumab due~     to safety concerns. The secondary objectives of this study in this study population are to~     evaluate the effects of daclizumab on the following: 1) Multiple Sclerosis (MS) relapse~     activity including the annualized relapse rate (ARR) and the proportion of participants~     experiencing relapses requiring hospitalization and/or steroid treatment; 2) MS-related~     outcomes measured using magnetic resonance imaging (MRI); 3) Safety and tolerability in~     participants previously treated with natalizumab.~   "
52362|NCT02881554|"~     This pilot trial studies how well single photon emission computed tomography (SPECT)/computed~     tomography (CT) with technetium Tc-99m sulfur colloid works in measuring liver function in~     patients with liver cancer that has or has not spread to other place in the body who are~     undergoing radiation therapy or surgery. Diagnostic procedures, such as sulfur colloid~     SPECT/CT scans, may measure normal liver tissue before, during and after treatment and help~     doctors plan better treatment for liver cancer patients.~   "
52363|NCT02881541|"~     Evaluate the complement of patient care course in the development of proctology outpatient~     surgery (CAP) by providing:~        -  An additional preoperative nurse consultation day hospital~        -  And a phone call from a nurse at D + 1 of the operation~      This corresponds to a reinforced support.~   "
52504|NCT02879695|"~     This phase I trial studies the side effects and best dose of blinatumomab when given with~     nivolumab alone or nivolumab and ipilimumab in treating patients with poor-risk CD19+~     precursor B-lymphoblastic leukemia that has come back after a period of improvement or has~     not responded to treatment. Monoclonal antibodies, such as blinatumomab, nivolumab and~     ipilimumab, may interfere with the ability of tumor cells to grow and spread.~   "
52364|NCT02881528|"~     The autoimmune diabetes ACCELERATOR PREVENTION TRIAL (adAPT) is based on the accelerator~     hypothesis. The trial is designed to establish whether metformin, an oral hypoglycaemic agent~     that is known to reduce insulin demand in type 2 diabetes (T2D), can do the same in children~     at risk of type 1 diabetes (T1D) and thereby prevent disease.~      The first phase of adAPT will screen participants aged 5-16 years (inclusive) for~     islet-related autoantibodies who are the siblings or offspring of individuals diagnosed with~     T1D before the age of 25years in Scotland and England.~      There are four principle islet-related antibodies associated with T1D. The presence of two or~     more confers a 40% risk of developing T1D in five years. While the presence of none or one~     antibody carries a similar risk for developing T1D to the general population (1 in 500 in~     5years).~      It is anticipated that 5% of those screened will be identified as double-antibody positive,~     these participants will be invited to join the intervention phase of the study - randomised~     controlled trial (RCT). Up to 200 eligible subjects could be identified by screening with a~     minimum of 90 being enrolled into the RCT phase.~      adAPT is a proposed three stage project. The current protocol defines the screening phase,~     Stage 1 and seamless entry into Stage 2. Screening will identify children and young people at~     high risk of developing T1D and invite them to participate in Stage 1 which will involve a~     minimum of 4 months treatment with either metformin/placebo, however Stage1 treatment will~     run seamlessly into Stage 2. Stage 1/2 treatment will last up to 21 months (to accommodate~     15months screening, 4 months treatment and 2 months analysis). Post Stage1 analysis/ late~     Stage 2 participation will last up to 36 months (participants enrolled early into Stage 1~     will have the longest intervention).~      During the Stage1 participants will be tested on three occasions (baseline, month 1 and month~     4) for metabolic response using a 5-point mixed meal tolerance test (MMTT). Testing will~     continue in Stage 1/2 with 3 visits further visits at months 8, 12, 18. Late Stage 2 visits~     will occur on months 24, 30 & 36.~      Participants will be invited to continue into Stage 3, taking treatment up to 60 months post~     analysis of Stage 1 and associated protocol amendment and additional consent.~   "
52365|NCT02881515|"~     Excess dietary salt increases the risk for cardiovascular events, even in people that are not~     hypertensive. There is some evidence that excess dietary salt exaggerates blood pressure and~     sympathetic nervous system responses to various perturbations and increases blood pressure~     variability. This proposal will examine the effects of low, medium, and high salt diets on~     cardiovascular reactivity and blood pressure variability.~   "
52366|NCT02881502|"~     Program： Clinical Study of Relationship Between Granulocyte Activation, HDAC2 and Severe~     Asthma Aim：The early prediction of severe asthma, early intervention on the disease, reduce~     the family and the national finance.~      design:This study is a single center randomized controlled trial designed by the Department~     of respiratory medicine, Xijing Hospital, as the main research unit.Compare the case~     group(severe asthma group and mild-and-moderate asthma group) and control group(healthy~     control group) by detecting the activity of MPO、NE、MMP-9 and ECP in the peripheral blood and~     the activity of HDAC2 in PBMCs of patients.~      case:60~      Case selection:~      Inclusion criteria: age 18-75 years old; diagnosis of asthma was clear; informed consent was~     signed.~      Exclusion criteria: poor compliance; cognitive ability is low; psychiatric disorders need to~     be combined with psychotropic medication.~   "
52367|NCT02881489|"~     The goal of this study is to investigate the safety and tolerability of autologous bone~     marrow-derived mesenchymal stem cells administration in the individuals with diagnosed~     amyotrophic lateral sclerosis.~   "
52368|NCT02881476|"~     The goal of this study is to investigate the safety and tolerability of allogeneic Wharton's~     jelly-derived mesenchymal stem cells administration in the individuals with diagnosed~     amyotrophic lateral sclerosis.~   "
52369|NCT02881463|"~     Knee joint osteoarthritis (OA) reduces functional mobility and performance of daily tasks~     such as rising from a chair. Therefore interventions aimed at improving muscle strength and~     sit-to-stand task performance are very important for these patients. The effect of exercise~     programs, including home exercise programs (HEP), on muscle strength, joint pain and function~     is well known and widely researched, yet not many studies have investigated the effect of an~     HEP on electromyographic activity (EMG) of muscles when performing everyday tasks, such as~     rising from and sitting on a chair. The aim of this study was to investigate effect of~     prehabilitation in women with severe knee joint OA scheduled for knee joint arthroplasty~     (TKA).~   "
52370|NCT02881450|"~     Knowledge of the descriptive epidemiology of MIs is very limited. The main objective of this~     study is to determine the prevalence of inflammatory myopathies in Alsace at the 1st January~     2012 with capture-recapture design using several independent sources of case~     identification.~   "
52371|NCT02881437|"~     Most immunodeficiencies are related to severe immunoglobulin deficiencies which require~     lifelong replacement therapy with immunoglobulin G (IgG) to reduce the incidence and severity~     of infections. IgG can be administered intravenously (IGIV) every 21 or 28 days or~     subcutaneously every week or every other week (IGSC) for subjects who do not tolerate IV~     infusions or have difficulties with venous access. No head-to-head data are available to~     directly compare HyQvia with conventional SCIG. However, SCIG is indicated for administration~     frequencies from daily up to every other week dosing while HyQvia is indicated for infusion~     frequencies every 2-4 weeks. This study is designed to assess the IgG trough level after~     switching from standard SCIG to every other week HyQvia and HyQvia every 3-4 weeks~   "
52372|NCT02881424|"~     Background:~      Alcohol-dependence is a chronic disease with a high risk of relapse. The main therapeutic~     outcome relies on relapse prevention which seeks to identify high risk situations and~     individual's response to these situations especially the emotional response to social~     environment. Alcohol-dependence also induces cognitive impairments leading to social~     cognition impairments increasing the risk of relapse.~      Familiarity is a key process in social interactions: it induces the feeling of prior~     knowledge of a stimulus without remembering consciously its identity. Followed by a second~     process based on the contribution of contextual information (recollection) familiarity allows~     face recognition.~      Main aim:~      Study of familiarity for faces in alcohol-dependence~      Secondary objectives:~      Highlighting correlations between familiarity impairments and clinical outcomes~   "
52373|NCT02881411|"~     The main aims of this preliminary research are to determine if combined self-soft tissue~     therapy (SSTT) alongside an established 6 week FMS Coping Skills Programme (FCSP) is a~     feasible and acceptable treatment approach for FMS. All participants on the six week FCSP~     will be randomly allocated to a control (FMS Coping Skills Programme) or intervention group~     (FMS Coping Skills Programme plus SSTT). All participants will be assessed for outcome~     measurements at the start of the feasibility study, at six weeks and three months after~     completion.~      This feasibility study hypothesis is that the SST approach will be acceptable to FMS patients~     and that the combined 6 week FCSP (hands off) and SSTT (hands on) will be beneficial. This~     feasibility study will inform a larger randomized controlled trial (RCT) on this combined~     treatment approach to FMS.~   "
54830|NCT02849288|"~     The trial is designed to assess safety and feasibility of the Bigfoot Biomedical Type 1~     Diabetes Management System (T1DMS) in up to 50 participants in a closely monitored Clinical~     Research Center (CRC) environment.~   "
52374|NCT02881398|"~     The primary objective of this investigation was to assess the impact of new mobile health~     devices on health outcomes among patients with rheumatic and structural heart disease in a~     resource limited area. To achieve this aim the investigators utilized smartphone-connected~     devices such as the smartphone-ECG, activity monitors, connected blood pressure devices and~     pocket-sized and handheld ultrasound. The main question asked in this investigation is if~     mobile health assessments accelerates medical-decision-making and if it shortens the time to~     definitive therapy.~   "
52375|NCT02881385|"~     Pressure Support Ventilation use Expiratory triggering sensitivity(Esense) to transfer~     inspiration to expiration,the value of Esense is fixed.That may lead to asynchrony between~     humans and ventilators,making people uncomfortable and prolonging weaning time.Some~     ventilators have auto cycle function Based on curves of pressure on respiratory patterns,it~     will make the transforming more synchrony with humans.Our prospective observational study~     will prove the superiority of the auto cycle function.~   "
52376|NCT02881372|"~     This is a single-center, prospective, pilot clinical trial in which children ages 3-17 years~     with eosinophilic esophagitis (EoE) who have a known food that triggers EoE flares receive~     oral desensitization with that specific food antigen, followed by reintroduction of that food~     into the diet. The purpose of this study is to investigate the safety and feasibility of oral~     desensitization in children with EoE so that, if determined to be safe, can be repeated on a~     larger scale to determine efficacy.~   "
52377|NCT02881359|"~     This study will assess the effectiveness of commercially available LifeSeal® Kit as measured~     by the incidence of post-operative clinical anastomotic leak rates in subjects undergoing low~     and ultralow anterior resection with an anastomosis. All patients treated with LifeSeal® will~     be offered to participate~   "
52378|NCT02881346|"~     This study aims to assess how the Enstilar® aerosol foam performs in daily real-life practice~     with regards to effectiveness and convenience of application to psoriasis plaques on body and~     extremities. In addition the profiles of patients prescribed Enstilar® will be described, and~     preceeding, concomitant and follow-up management will be mapped. The study will be conducted~     in about 100 dermatology clinics all over Germany,~   "
52379|NCT02881333|"~     Currently, for a patient with intellectual disability without a recognizable syndrome (most~     cases), the way to diagnosis is often long, tedious and expensive because different~     approaches are used one after the other to identify structural variants (duplications,~     deletions and other) and point mutations (sequencing of one or more candidate genes). The~     development of high-throughput sequencing techniques (next generation sequencing: NGS) has~     drastically increased the detection of point mutations offering the possibility to test a~     large number of genes simultaneously. NGS also shows a huge potential in detecting structural~     variants. The objective of this research is to assess the sensitivity of a simultaneous~     detection of point mutations and structural variants by NGS approaches. This would bring~     together in a single step the equivalent of performing an array-Comparative genomic~     hybridization (CGH) analysis plus performing a targeted sequencing of candidate genes.~     Investigators will compare two approaches for this simultaneous detection: a targeted~     enrichment of candidate genes coding regions using probes covering these regions associated~     with a backbone of genomic probes, an approach that could be implemented immediately in~     diagnostic at the hospital, and a whole genome sequencing (WGS), that is currently a too~     expensive tool for routine diagnosis but that should be the approach used in the future.~     Investigators will compare these two approaches to the traditional one: CGH array + WGS. The~     implementation of a one step strategy to detect both types of mutations (punctual and~     structural) would accelerate and improve the access of patients to a molecular diagnosis.~   "
52380|NCT02881320|"~     The primary objectives of this study are to evaluate the steady state pharmacokinetics (PK)~     for bictegravir (GS-9883) and confirm the dose of bictegravir/emtricitabine/tenofovir~     alafenamide (Biktarvy®; B/F/TAF) fixed-dose combination (FDC) in HIV-1 infected,~     virologically suppressed adolescents (12 to < 18 years of age) and children (6 to < 12 years~     of age). This study will also evaluate the safety and tolerability of B/F/TAF FDC through~     Week 24 in HIV-1 infected, virologically suppressed adolescents and children.~   "
52381|NCT02881307|"~     The purpose of this research study is to evaluate if a weight loss intervention will improve~     your rheumatoid arthritis disease activity.~   "
52382|NCT02881294|"~     The purpose of the study is to investigate the effect of Food, Gender, and Age on the~     Pharmacokinetic Profile of SUVN-G3031 in Healthy Subjects~   "
52383|NCT02881281|"~     Adolescence is the most important period of growth for humans. The conflict and disagreement~     which exists within family relationships will affect the children behaviors. Family~     relationships are the cause of many problems in adolescents, to develop a training program on~     problem-solving skills for adolescent girls to change their relationship with their parents.~   "
52384|NCT02881268|"~     Open-label, non-randomized, prospective, single center, observational, translational study~   "
52385|NCT02881255|"~     The purpose of the study is to compare standard, single chamber transvenous ICD to~     sub-cutaneous ICD in occurrence of perioperative and long term device related complications~     and failed appropriate clinical shocks and arrhythmic death.~   "
52386|NCT02881242|"~     This phase II trial studies how well trametinib works in treating patients with~     hormone-resistant prostate cancer that is growing or getting worse and has spread to other~     parts of the body. Trametinib may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth.~   "
52387|NCT02881229|"~     This study aims to develop a clinical database of patients presenting with vulvar complaints~     in order to comprehensively assess the presentation and current trends in management of~     vulvar disease.~   "
52388|NCT02881216|"~     This study sought to compare procedural performance of a new coronary stent generation, that~     is already available in Germany, with hitherto established current drug-eluting stents.~   "
52389|NCT02881203|"~     This study investigates the Breathe Well device to test whether it is superior to the~     existing treatment standard of the Varian Realtime Position Management (RPM) system in~     assisting patients with deep inspiration breath hold.~   "
52390|NCT02881190|"~     A tolerance, safety and pharmacokinetic ascending dose phase I Study of RC48-ADC administered~     intravenously to subjects with HER2-positive malignant in advanced malignant solid tumors.~   "
52391|NCT02881177|"~     The purpose of this pilot study is to determine the tolerability, feasibility, and~     preliminary effectiveness of intranasal oxytocin administration prior to motivational~     enhancement group therapy sessions on laboratory-based measures of addiction, social~     connectedness, and stress responsivity in methamphetamine(meth)-using men who have sex with~     men (MSM). The investigators propose a randomized, double-blind, study of intranasal oxytocin~     versus placebo 40 IU prior to each of six Motivational Interviewing Group Therapy (MIGT)~     sessions in 28 mixed HIV sero-status MSM initiating treatment for amphetamine use disorder.~   "
52392|NCT02881164|"~     To evaluate the acute effect of a low and high glycemic index breakfast on the glycemic~     response and satiety in subjects with type 2 diabetes mellitus under intensive insulin~     therapy.~   "
52393|NCT02881151|"~     This study involves the treatment of cognitive impairment secondary to moderate to severe~     brain injury using central thalamic deep brain stimulation. Although all patients will~     receive stimulation continuously through a surgically implanted pacemaker-like device, half~     of the patients will have the device deactivated during a blinded assessment phase. The~     device will be reactivated following this assessment and patients will have the option to~     continue stimulation in an open-label continuation.~   "
52394|NCT02881138|"~     A tolerance, safety and pharmacokinetic ascending dose Phase I Study of RC48-ADC Administered~     Intravenously to Subjects With HER2-Positive malignant in Advanced Malignant solid Tumors.~   "
52395|NCT02881125|"~     This phase I trial studies the side effects and best dose of nortriptyline hydrochloride when~     given together with paclitaxel in treating patients with small cell carcinoma that has come~     back. Nortriptyline hydrochloride, may help disrupt survival signals and cause cancer cell~     death. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Giving nortriptyline hydrochloride and paclitaxel may work~     better in treating patients with small cell carcinoma.~   "
52396|NCT02881112|"~     The study is an open-label, non-controlled study of the safety and effectiveness of~     investigator determined Provant therapy in subjects with pain and/or edema from various pain~     etiologies. Information collected in the study will be entered into a registry database.~   "
52397|NCT02881099|"~     Prospective observational study of Parkinson's disease with repeat clinical assessment and~     biobanking of blood samples.~   "
52398|NCT02881086|"~     A phase IV study with the primary goal to optimize therapy of adult patients with acute~     lymphoblastic leukemia or lymphoblastic lymphoma (LBL) by dose and time intensive, pediatric~     based chemotherapy, risk adapted stem cell transplantation (SCT) and minimal residual disease~     (MRD) based individualised and intensified therapy. Study will further evaluate the role of~     asparaginase intensification, the extended use of rituximab and the use of nelarabine as~     consolidation therapy in T-ALL in a phase III-part of the study. Furthermore two~     randomisations will focus on the role of central nervous system (CNS) irradiation in~     combination with intrathecal therapy versus intrathecal therapy only in B-precursor ALL/LBL~     and the role of SCT in high-risk patients with molecular complete remission. Finally a new,~     dose reduced induction therapy in combination with Imatinib will be evaluated in Ph/BCR-ABL~     positive ALL.~   "
52399|NCT02881073|"~     The primary aim is to establish the effectiveness of plasma PlGF measurement in reducing~     maternal morbidity (with assessment of perinatal safety in parallel) in women presenting with~     suspected pre-eclampsia prior to 37 weeks' gestation.~      The long term aim is to demonstrate that knowledge of PlGF measurement enables appropriate~     stratification of the antenatal management of women presenting with suspected pre-eclampsia,~     such that those at highest risk receive greater surveillance with a decrease in maternal~     adverse outcomes, and those at lower risk can be managed without unnecessary admission and~     other interventions, such that the results would influence international clinical practice in~     antenatal patient healthcare~   "
52400|NCT02881060|"~     Objective: Because many people with type 1 diabetes drink ethanol and because glucagon is~     used to treat mild hypoglycaemia, it is essential to determine whether ethanol will impair~     the effectiveness of glucagon to increase glucose, which may impair the effectiveness of the~     dual hormone treatment in preventing hypoglycaemia.~      The purpose of this study is to determine, whether ethanol influences the glucose response to~     subcutaneous glucagon during mild hypoglycaemia.~      The investigators hypothesize that prior evening ethanol consumption does not reduce the~     effect of a glucagon bolus to raise plasma glucose compared with no prior ethanol~     consumption.~      The study aims:~        1. To determine the late effects of ethanol on the efficacy of subcutaneous glucagon to~          restore plasma glucose after an episode of mild hypoglycemia.~        2. To determine the late effects of ethanol on the counter-regulatory hormones and~          hypoglycaemia awareness during mild hypoglycaemia~      A double-blinded placebo-controlled study will be conducted. Participants will serve as their~     own controls. Eligible participants will after an informed consent complete two study visits,~     one with and one without ethanol consumption, in a random order. On each study visit,~     participants are induced a insulin induced hypoglycemia, seven-eight hours after a meal with~     or without ethanol. Once plasma glucose is below 3.9 mmol/l, a subcutaneous injection of 100~     mcg glucagon is administered. Two hours later a second bolus is administered.~   "
52401|NCT02881047|"~     Graft versus host disease (GVHD) is a common complication of allogeneic stem cell~     transplant.Chronic GVHD is characterized by skin thickening and tightening. Advanced~     sclerosis can lead to reduced range of motion and incapacitating joint contractures. Once~     present, there are few therapeutic options. We will treat sclerosis and limb contractures~     with an ablative fractional laser, a device FDA-approved for scar treatment. This approach~     has successfully treated contracturesdue to burn scars.~   "
52402|NCT02881034|"~     Anemia is more frequent in patients receiving telaprevir with pegylated-interferon/ribavirin~     than in those receiving pegylated-interferon/ribavirin alone. The objective was to measure~     the impact of telaprevir on ribavirin bioavailability and to assess the concomitant renal~     function.~   "
52505|NCT02879682|"~     To compare presurgical motor mapping by navigated transcranial magnetic stimulation for~     surgery (nTMS) of rolandic lesions to surgery with mapping without implementing these data~     into neuronavigation as control.~      Primary objective: Permanently new postoperative deficit is lower when the preoperative motor~     mapping is available to the surgeon~   "
52403|NCT02881021|"~     Introduction: Rotator cuff tendinopathy (RCTe) is the most frequent cause of shoulder pain,~     resulting in considerable losses to society and public resources. Muscle imbalance and~     inadequate sensorimotor control are deficits often associated with RCTe. Kinesiotaping (KT)~     is widely used by clinicians for rehabilitation of RCTe. While previous studies have examined~     the immediate effects of KT on shoulder injuries or the effects of KT as an isolated method~     of treatment, no published study has addressed its mid- and long-term effects when combined~     to a rehabilitation program for patients with RCTe. The primary objective of this randomised~     controlled trial (RCT) will be to assess the efficacy of therapeutic KT, added to a~     rehabilitation program, in reducing pain and disabilities in individuals with RCTe. Secondary~     objectives will look at the effects of KT on the underlying factors involved in shoulder~     control, such as muscular activity, acromiohumeral distance (AHD), and range of motion (ROM).~      Methods and analysis: A single-blind RCT will be conducted. Fifty-two participants, randomly~     allocated to one of two groups (KT or no-KT), will take part in a 6-week rehabilitation~     program. The KT-group will receive KT added to the rehabilitation program, whereas the no-KT~     group will receive only the rehabilitation program. Measurements will be taken at baseline,~     week-3, week-6, week-12 and 6-month. Primary outcomes will be symptoms and functional~     limitations assessed by the DASH questionnaire. Secondary outcomes will include shoulder ROM,~     AHD at rest and at 60º of abduction, and muscle activation during arm elevation. The added~     effects of KT will be assessed through a 2-way ANOVA for repeated measures.~      Discussion: Investigations with a high level of evidence are needed to determine scientific~     evidence-based concerning the efficacy of KT for the rehabilitation of individuals with RCTe.~     This RCT will be the first to assess the effectiveness of KT added into a conventional RP for~     patients with RCTe, addressing underlying factors that could explain the possible benefits of~     this method, in a mid- and long-term. Results may contribute to build solid evidence on the~     addition of KT in a physiotherapy intervention for this population.~      Ethics and Dissemination: Ethics approval was obtained from the Ethics Committee of Quebec~     Rehabilitation Institute (IRDPQ) of the CIUSS-CN. Results of this protocol will be~     disseminated through international publications in peer-reviewed journals, in addition to~     international conference presentations.~   "
52404|NCT02881008|"~     Randomized, open-label multicentre clinical trial of daily Myrcludex B versus entecavir in~     patients with HBeAg negative chronic hepatitis B.~   "
52405|NCT02880995|"~     The first purpose of this study is to determine if dopamine synthesis capacity is~     significantly lower in treatment non-responders from illness onset relative to treatment~     responders. And the second purpose of this study is to determine the potential of [18~     fluorine(F)]-DOPA to be used to predict treatment response to antipsychotic treatment in~     first episode psychosis.~   "
52406|NCT02880982|"~     The investigators will conduct a n=5,400 Phase 3, double-blind, individually randomised~     placebo-controlled clinical trial of 5 years' duration in primary schools in City of Cape~     Town Metropolitan Municipality, Western Cape Province, Republic of South Africa.~      The primary objective of the trial is to determine whether a weekly oral dose of 0.25 mg~     (10,000 IU) vitamin D3, administered for three years, reduces risk of acquisition of latent~     tuberculosis infection (LTBI) in Cape Town primary schoolchildren.~      Statistical analysis will be performed on an intention-to-treat basis to compare acquisition~     of LTBI in intervention vs. control arms during three-year follow-up. The primary analysis~     will be logistic regression with presence/absence of LTBI at follow-up as the outcome,~     adjusted for a random effect of school of attendance.~   "
52407|NCT02880969|"~     End stage renal disease (ESRD) is a severe pathology, treated by dialysis on standby of graft~     availability. Being under dialysis requires a recourse to pluri-weekly magazine of health~     care system, impacting negatively patient's quality of life (QoL) and their entourage, at a~     psychological, physical and social level.~      Although further studies have assessed QoL in ESRD grafted children, a lack of information~     exists concerning patients' QoL during dialysis before graft. In addition, some limits could~     be listed, these studies have small samples, 50 patients at all, and only clinical~     determinants are studied. A larger clinical research assessing children's QoL studying~     individual and populational factors is necessary.~      The aim of the study is to assess the influence of individual and populational determinants~     on children's QoL with ESRD, treated by dialysis.~      Material & Method An exhaustive inclusion of patient with ESRD treated by dialysis will be~     realized at 20 French Pediatrics Dialysis Centers. Inclusion criteria are i) two genders, ii)~     younger than 18 years old, iii) having an ESRD treated by dialysis, iv) attending at one of~     the French Pediatrics Dialysis Centers for treatment between the 1st September 2012 and the~     31th August 2014, v) being at their fourth to sixth week of dialysis. Patients will be~     re-evaluated at 4th month and 7th month after first dialysis. Informed consent will be signed~     by patient and their mainly caregiver.~      Patient's QoL will be assessed using self-administered questionnaires Kidscreen 10 and VSP-A.~     In addition coping (KidCope), anxiety (STAI-C, STAI-Y), personality / attachment (IPPA),~     optimism (Y-LOT) measures and socio-demographic data will be collected. Self-administered~     questionnaires will be used for assessing caregivers' Qol (SF36), anxiety (STAI-Y), coping~     (BriefCope situational format), health care system satisfaction (Care quality scale) and~     burden (Zarit Caregiver Burden Inventory). Child's QoL evaluated by caregivers will be~     assessed using QUALIN, Kidscreen 10 parent and VSP-Ap. In addition, socio-demographic data,~     urban environment and economic environment will be collected. Clinical data will be collected~     by health professionals.~      Results expected A sample of 136 children with ESRD is expected for identifying individual~     and populational factors which could influence chronic dialysed children QoL, in order to~     propose adjustments to optimize these patients quality of life.~   "
52408|NCT02880956|"~     This study seeks to evaluate the efficacy and safety of ABBV-8E12 in subjects with Early~     Alzheimer's Disease.~   "
52409|NCT02880943|"~     This is a prospective, multicentre, open-label, phase I/II study to evaluate the maximum~     tolerated dose (MTD), and the most successful dose (MSD) of XOFIGO®, in renal cancer patients~     with metastases to bone, without (Group A) or with (Group B) visceral metastases.~   "
52410|NCT02880930|"~     Vitamin D deficiency is highly prevalent in the UK. Research shows that vitamin D enhances~     the immune system and may help protect against chest infections that can cause wheezing~     illness or worsen asthma symptoms. The Department of Health recommends a dose of 10~     micrograms of vitamin D/day to prevent severe vitamin D deficiency in children. However, many~     studies have reported that this dose is not enough to raise plasma 25(OH)D concentration to~     the levels most likely to prevent against worsening of asthma symptoms. Such studies suggest~     that 25 micrograms of vitamin D/day. This dose is safe but its effects on vitamin D blood~     levels have not yet been specifically tested in children with asthma/wheeze. This study is~     designed to determine the optimal oral daily vitamin D supplementation dose to treat vitamin~     D deficiency in children with asthma or preschool wheeze. Over the 6-month course of the~     study, participants will meet with the study team four times in clinic or in their own home~     and will be contacted by telephone five times. Children will be asked to give a drop of blood~     via a fingerprick to test their vitamin D level and a sample of nasal epithelial lining fluid~     for measurement of inflammatory markers on three separate occasions.~   "
52447|NCT02880449|"~     The aim of the project is pilot an intervention to promote physical activity (PA) among older~     women.~      Participants will be women aged ≥50 years attending an identified community centre situated~     in a socioeconomically deprived area of Belfast. The intervention consists of education,~     social support and information on local opportunities for physical activity (PA), based on~     Social Practice Theory. A stepped wedge design shall be used. The intervention was developed~     using findings from a literature review, systematic review and interviews with stakeholders.~     Outcome measures are accelerometer data, self-reported PA, a mental health questionnaire and~     qualitative interviews.~   "
52854|NCT02875132|"~     To determine the Overall Response Rate (ORR), as defined as rate of complete response (CR)~     and partial response (PR) as per RECIST 1.1 in biological treatment-naïve patients with acral~     lentiginous melanoma treated with pembrolizumab~   "
52411|NCT02880917|"~     Chronic pain represents an important health problem responsible for decreases in quality of~     life, and is associated with great negative impact in society and economy. In many cases, its~     treatment does not reach therapeutic success causing health professionals and patients~     dissatisfaction. Chronic pain is also associated with somatization, hopelessness and~     catastrophizing thinking. These information processing includes sensorial, emotional and~     cognitive-appraisal thinking, which manifests the working of neural networks at cortical and~     sub-cortical levels. Attention and memory are a central aspect in the processing of pain~     modulation. Like in addictions (e.g. smoking, alcohol), chronic pain may debut with~     displacement in the focus of attention and alterations in the sensorial processing in the~     incentive-motivation tests. Considering that other studies have indicated that experimental~     and clinical pain is capable of modulating cognitive activities such as attention,memory and~     expectation, in this study the investigators will test whether cognitive training, tDCS, or~     the combination of both interventions decrease cognitive deficits associated with~     Fibromyalgia~   "
52412|NCT02880904|"~     The study aims to validate a vulvar scarring grading scale for lichen sclerosus (LS).~   "
52413|NCT02880891|"~     The microthreaded and platform switched implants could control the stress in the suitable~     range. The splint would disturb the function. So it is necessary to know whether the splinted~     single-unit crowns is fit for the adjacent multi-implants.~      Outcome variables: Splinted single-unit crowns on one side implants and non-splinted~     single-unit crowns on the other side Materials and method: 80-100 consecutive implants in at~     least 20 patients would be included for implant- supported restorations in the posterior~     maxilla or mandibular. All patients would be in general good health. For every patient, the~     same posterior teeth had lost on both sides for more than 6 months. All patients were treated~     by the same qualified surgeon.~      Prosthetics procedure would be performed by an experienced prosthodontist. The two sides were~     allocated to the test or the control group according to the predefined computer-generated~     randomization table. Clinical evaluations and radiographic analysis were performed by an oral~     and maxillofacial radiologist who was not aware of the type of Prosthetics technique that was~     used.~   "
52414|NCT02880878|"~     This is a multicenter, randomized, adaptive clinical trial comparing standard medical~     management to early (<24 hours) surgical hematoma evacuation using minimally invasive~     parafascicular surgery (MIPS) in the treatment of acute spontaneous supratentorial~     intracerebral hemorrhage.~   "
52415|NCT02880865|"~     This study aims to provide evidence that co-administration of measles-mumps-rubella vaccine~     (MMR) and live attenuated SA 14-14-2 Japanese encephalitis vaccine (CD-JEV) does not~     adversely affect immunogenicity or safety.~   "
52416|NCT02880852|"~     In China, Belimumab (GSK1550188) will be developed for a dosing regimen of once-monthly~     intravenous (IV) infusion for the treatment of SLE. This open-label, single dose study will~     evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of~     belimumab in Chinese SLE subjects. A total of approximately 20 subjects will be enrolled to~     receive IV infusion of 10 milligrams per kilogram (mg/kg) GSK1550188 on Day 0 for the~     treatment of SLE. Subjects will be followed for 84 days after the administration of drug.~   "
52417|NCT02880839|"~     To compare the internal fixation results of three pedicle screw implantation methods and~     investigated the accuracy and safety of digital navigation-assisted pedicle screw placement.~   "
52418|NCT02880826|"~     The tools to measure safety culture (CS) have recently become available. No study has focused~     on the measure in France, apart from pilot studies. intensive services are particularly at~     risk of serious adverse events occurred (SAEs). Patients who are hospitalized are in fact~     fragile and precarious clinical condition requires rapid decision taken often. Diagnostic or~     therapeutic strategies have report risk-benefit narrow. They may well be complicated by~     EIG.Safety of care is a priority in the field of health in general, and especially in~     intensive care. CS measure in this context seems particularly relevant.~      The main objective is to describe the CS intensive care units in France. The study will~     explore the development of the CS level for the units investigated.~      This study will also describe the main features of RMM practiced in intensive care units in~     France.~   "
52419|NCT02880813|"~     This pilot study will look at whether infusion of nutrients into the duodenum or into the~     stomach will result in:~        1. decrease in hunger and food intake~        2. greater weight loss due to loss of body fat with reductions in waist and hip~          circumferences~        3. improvements in other weight-related health conditions such as diabetes, high blood~          pressure, and high blood triglycerides. Inclusion criteria: 25-60 years old with a BMI~          of ≥ 30≤55 kg/m2.~      Subjects (16 individuals) will be in the study for 12 days and have a dobhoff tube placed at~     the start of the study. Subjects will visit MCRU daily for 12 days where meals will be~     provided, and where anthropometric measures, blood work during an oral mixed meal tolerance~     test (study start and study end), and surveys will be completed. The dobhoff tube will remain~     in place until the end of the study.~   "
52420|NCT02880800|"~     The study aims to compare the use of intravenous patient controlled analgesia (IVPCA) versus~     the delivery of pain relief (per oral and intravenous (IV) medications as rescues analgesia)~     on an as needed basis within a well defined fast track protocol that includes multimodal~     analgesia for patients who are undergoing elective primary knee replacement surgery. The~     investigators assumed that with the multimodal analgesia regimen without the use of IVPCA~     will demonstrate decreased consumption of postoperative opioids, reduced incidence of opioids~     related side effects and decreased length of stay in the hospital.~   "
52421|NCT02880787|"~     The purpose is to evaluate the reproducibility of neuromuscular monitoring data of recovery~     from neuromuscular blockade, obtained with TOFScan® and TOF-Watch SX®, in adult and pediatric~     population.~      Secondary purposes are to evaluate the reproducibility of data obtained with 2 monitors for:~        -  the onset of clinical action of curare: suppression of the first response of train of~          four monitoring (T1) of 95% initial value~        -  the duration of clinical action of curare: recovery of the first response of train of~          four monitoring (T1) to 25% initial value~        -  recovery of first (T1), second (T2), third (T3) and fourth response (T4) of train of~          four monitoring, and recovery of T4/T1 to 40% and 60% initial value (T4/T1 0.4 and 0.6)~        -  complete recovery from curarisation, at T4/T1=90% and T4/T1=100%.~   "
59338|NCT02790164|"~     The main purpose of this study is to test the hypothesis that continuous NMB could improve~     outcome in cardiac arrest patients treated with therapeutic hypothermia.~   "
52422|NCT02880774|"~     Introduction: Temporomandibular joint dysfunction (TMD) is characterized for being a complex~     and multifactorial pathology, where functional and pathological changes commit~     temporomandibuar articulation, masticatory muscles, and other associated structures. In the~     light of the whole complexity of the DTM noted the necessity of interdisciplinary treatment,~     including physical therapy with the use of manual features, has been excelling. Objective:~     The aim of this study is to evaluate the influence of mandibular nonspecific mobilization on~     the mandibular movement and lateralidades, through the three-dimensional kinematics in~     subjects with diagnosis of TMD, as well as analyze the behavior of pain, quality of life and~     functionality of individuals with DTM pre, immediately after and 30 days of 12 treatment~     sessions. Method: This is a clinical trial randomised, placebo-controlled and blind, designed~     to study the effects of Mandibular Nonspecific Mobilization x Placebo (detuned ultrasound).~     Individuals will be randomised controlled trials and allocated into two groups: Group A~     (intervention) and Group B (placebo) and evaluated by the Research Diagnostic Criteria for~     Temporomandibular joint Disorders (RDC/TMD) for diagnosis of TMD, numeric scale of Pain~     (END), quality of life questionnaire (WHOQOL-BREF), Patient specific Functional Scale and~     Kinematic Analysis Tridiemsnional. Statistical Analysis: Mandibular movement will be the~     primary outcome and will be quantified by three-dimensional kinematic analysis. The pain,~     Functionality and quality of life will be the secondary outcomes. Initially the distribution~     of data will be checked by the Shapiro-Wilk test. In comparisons between the groups, if the~     data present normal distribution will be used a repeated measures ANOVA to two factors, being~     these: Group (intervention and placebo) and treatment (pre and post-intervention), with~     Bonferrone correction. If the data do not show normal distribution, a logarithmic function is~     used to correct striping. As level of significance will be used p < 0.05.~   "
52423|NCT02880761|"~     A cohort including more than 100 maintenance hemodialysis patients will be followed up~     according to a certain Following-up System of Native Arteriovenous Fistulae (AVF)~     prospectively. The assessment results of the Following-up System of AVF help the physicians~     make decisions of AVF surgery and puncture methods. The results of this study would identify~     the effect of the system on survival of AVF. Other 100 hemodialysis patients from other~     centers will be treated by routine protocol and compared to the experiment goup.~   "
52424|NCT02880748|"~     Patients with colorectal adenomas are suggested to receive polypectomy. A substantial number~     of adenomas may be missed in patients with polyps found by previous colonoscopy. And water~     exchange (WE) method may increase the detection of missed adenoma compared with traditional~     air insufflation (AI) colonoscopy. The investigators aim to investigate whether water~     exchange colonoscopy method, compared with air insufflation method, can improve the detection~     of missed adenomas in patients undergoing selective polypectomy.~   "
52425|NCT02880735|"~     It has been suggested that patients with Myotonic Dystrophy type 1 have primary altered~     ventilatory response to chemical stimuli and chronic hypoventilation is related not always to~     muscle weakness. Also, it is known that Non Invasive Mechanical Ventilation can improve~     ventilatory response to chemical stimuli, especially to hypercapnia.~      This study evaluates the effect of Non Invasive Mechanical Ventilation on ventilatory~     response in patients with Type 1 Myotonic Dystrophy, the ventilatory response to chemical~     stimuli will be measured before and after mechanical ventilation in patients with myotonic~     dystrophy type 1.~   "
52426|NCT02880722|"~     Reliable patient reported outcome measures (PROM's) for symptom assessment in irritable bowel~     syndrome are essential in order to investigate natural disease course and potential treatment~     options aimed at symptom improvement, since biological markers are currently unavailable.~     Currently used symptom assessment methods, i.e. end-of-day or end-of-week questionnaires,~     have considerable limitations. The Experience Sampling Method (ESM), an electronic~     questioning method characterized by random and repeated, momentary assessments in the~     subject's current state and environment, might overcome these limitations. Aim of this study~     is to validate an IBS-specific electronic patient-reported outcome measure, based on the~     Experience Sampling Method-principle, for symptom assessment in IBS.~   "
52427|NCT02880709|"~     Major weight loss and taste changes are well documented in patients with hematological cancer~     during chemotherapy. It has previously been documented, that such patients have preferences~     for much umami, a little sweet, sour and salt, and no bitter. The purpose of the study was to~     convert these results into real diets. Patients participated in two sensory pilot studies~     (n=10), where dishes were tested for preferences before and after chemotherapy. From these~     results four dishes were selected and tested on 32 patients in 30 days in a cross-over~     design. The diets resulted in a beneficial and statistical significant difference in weight~     development (p= 0.0008), with 1.2 ± 1.9 kg (+2%) in the intervention period and -2.8 ± 5.2 kg~     (-4%) in the control period. This difference persisted after sensitivity analysis (± 10%) p=~     0.005. However, the nutritional intake was still low in both periods, and the treatment with~     cytarabin turned out to be a major confounder as dosage was significantly higher in the~     control period.~   "
52428|NCT02880696|"~     A key function of our brain is to identify temporal structures in the environment and use~     them to form expectations. These expectations allow us to plan and organize our behavior~     towards changes in the environment, and optimize the use of our attentional and motor~     resources. They also allow us to establish harmonious social interactions, coordinating us~     with our interlocutor during an exchange. Our ability to form temporal expectations seems to~     emerge very early but the development of this process is unknown. We only know that a set of~     basic skills, probably related to that ability, are present from birth. This suggests that~     temporal processing capabilities emerge during the prenatal period, but this has not been~     studied. The objective of this project is to study preterm infants brain's ability to process~     the intervals between stimuli and to form expectations on that basis.~   "
52429|NCT02880683|"~     A single-center feasibility study in patients undergoing cardiac catheterization, to~     investigate the acute hemodynamic effects of transvenous cardiac autonomic nerve stimulation.~   "
52430|NCT02880670|"~     This is an open-label, single-dose, study in healthy males. The primary objective is to~     assess the pharmacokinetics (PK), metabolism, and routes of elimination of a single oral dose~     of radiolabeled BMS-986142 in healthy male subjects.~   "
52431|NCT02880657|"~     The objective of this study is to evaluate the influence of a 10 weeks SODB® supplementation~     in physical condition improvements of healthy subjects, in comparison to a placebo.~   "
52432|NCT02880644|"~     In patients with macular edema secondary to CRVO, Aflibercept demonstrated efficacy and~     safety in 2 parallel trials, interventional phase III studies, COPERNICUS study performed in~     United States and GALILEO study performed in Europe and Asia/Pacific.~      With the project of Hermes Study, the first observational study conducted in France in~     patients with CRVO and treated with aflibercept, we would like to evaluate in real life the~     monitoring and the use of Aflibercept. The primary objective of this study will also be based~     on anatomic outcomes. The evolution of retinal ischemia and the degree of non-retinal~     perfusion will be particularly evaluated by using ultra wide field angiography technology.~   "
52435|NCT02880605|"~     Coronary revascularization (CR) is increasing rapidly in China and varies significantly in~     proportion ( PCI:CABG=15:1). Few studies assess the appropriateness of CR in China. Recently,~     National Center for Cardiovascular Disease organized experts to release Chinese version~     appropriate use criteria(C-AUC) for coronary revascularization by RAND method aimed at~     regulating indications of CR. The criteria is considered to contribute to clinical practices,~     quality assessment and health insurance policy, however, the validation of C-AUC is unknown.~      Thus the investigators study aims at assessing the validation of Chinese AUC by multi-center~     prospective registry. The investigators will recruit 4000 patients undergoing elective~     coronary angiography with positive outcome consecutively and collect baseline information.~     Sequently, one-year follow up will be done to collect the prognose, including death,~     rehospitalization, medicine, medical compliance and life quality etc. One hand, the~     investigators will compare the outcomes between different therapies in the same indications~     according to C-AUC to evaluate the validation of C-AUC. On the other hand, the investigators~     will evaluate the rationality of CAD therapy in Beijing by C-AUC.~   "
52436|NCT02880592|"~     This is a multi-center, randomized controlled trial designed to evaluate the use of fresh~     hypothermically stored human amniotic membrane (Affinity; fHSAM) to determine if addition of~     fHSAM to standard of care (SOC) results in faster healing of Wagner grade 1 and 2 DFUs~     compared to SOC alone.~   "
52437|NCT02880579|"~     The Ischemic Brain Vascular Accident (CVA) is a major public health issue. An Early and~     appropriate charging anyone with stroke is essential to reduce mortality, reduce dependency~     and promote recovery of autonomy. Intravenous fibrinolysis in patients with cerebral~     infarction (NINDS 1995), is reserved for a small proportion of highly selected patients. It~     therefore remains a significant therapeutic challenge, especially for patients with~     against-indications to fibrinolysis or in whom there is no immediate benefit. For twenty~     years of mechanical devices have been developed to remove, as quickly as possible, the cause~     of intracranial arterial occlusion and allow restoration of blood flow before brain damage is~     irreversible.~      NTF The protocol is part of the evaluation process of our clinical practices recommended by~     the National Health Authority (HAS), in the specific context of mechanical thrombectomy~     performed in French centers of interventional neuroradiology working with neurovascular units~     (A V).~   "
52438|NCT02880566|"~     Prospective randomised double-blinded placebo-controlled trial on the efficacy of scalp~     blocks on hemodynamic stability and opioid consumption during and after craniotomy.~   "
52439|NCT02880553|"~     The World Health Organization International Classification of Functioning, Disability and~     Health has shown that the environment can play a major role in patients' disability, and~     hence in their quality of life. This study considers social dimensions of quality of life,~     particularly family as well as social and professional networks.~   "
52440|NCT02880540|"~     Obesity represents one of the most important public health issues according to the World~     Health Organization and it has reached epidemic proportions globally. The prevalence of~     childhood obesity has rapidly increased over the past decade and is associated with multiple~     co-morbid disease states . It is estimated that approximately 15.5% of children and~     adolescents are obese with a body mass index of ≥95th percentile for age . This not only~     poses health concerns for the patient, but also places increased demands on our healthcare~     system that is already overwhelmed by burgeoning costs. Moreover, obese children and~     adolescents who maintain excessive weight as adults are predisposed to cardiovascular disease~     and premature death.~      In carefully selected patients who have failed to lose weight by diet and exercise, bariatric~     surgery provides an option to obtaining a healthy weight.~      It is increasingly becoming an attractive option, with the number of adolescents undergoing~     bariatric surgery in the United States tripling between 2000 and 2003.~      Obese patients are often afflicted with multi-organ dysfunction and obstructive sleep apnea,~     which presents unique challenges to the anesthesiologist managing their perioperative care .~     Bariatric surgery in obese adolescents may be associated with significant postoperative pain.~     Potent intravenous opioids such as fentanyl and morphine are at the mainstay of perioperative~     pain management. Unfortunately, respiratory depression and airway obstruction can often occur~     following administration of opioids in obese patients . This makes providing a safe analgesic~     regimen difficult during the perioperative setting. As opioids can be associated with~     respiratory depression and upper airway obstruction, surgeons and anesthesiologists alike~     must reconcile the adequacy of pain control with the risk of respiratory complications after~     surgery in obese adolescents.~   "
52441|NCT02880527|"~     Polymyositis and dermatomyositis are characterized by the association to a myopathic~     syndrome, inflammatory infiltrates in the skeletal muscle. They remain, even today, an~     important factor of morbidity and mortality in these patients. At present, studies that~     evaluated the prevalence of polymyositis / dermatomyositis are very few; they were mainly~     recorded in the United States and Japan, the prevalence of polymyositis / dermatomyositis has~     been estimated between 3.5 and 21.5 cases / 100 000 (according to the old diagnostic criteria~     of Bohan and Peter). However, previous works are old and retrospective; above all, they have~     almost always been performed (90% of cases) from cases reported to the hospital, leading to~     selection bias and an underestimate of the true prevalence of polymyositis / dermatomyositis~     in the general population.~      Thus, these data lead to achieve this epidemiological study, descriptive, multicenter, based~     on the population of Normandy.~   "
52442|NCT02880514|"~     A prospective, randomized, single-blind, intra-patient controlled, multicenter study~   "
52443|NCT02880501|"~     Minimally invasive PFNA fixation for the treatment of intertrochanteric femoral fracture will~     be used in 20 patients within 2 years to objectively validate the safety and effectiveness of~     PFNA in the treatment of fracture of long tube-like bone.~   "
52444|NCT02880488|"~     The validation of a French questionnaire is very important to assess rigorously and~     objectively the impact of the treatments of strabismus and amblyopia on children quality of~     life.~   "
52445|NCT02880475|"~     This is an open-label, randomized, single-dose, parallel group study. The objectives of this~     study are to assess pharmacokinetics of oxycodone and naloxone from oxycodone/naloxone (OXN)~     prolonged release (PR) tablet 5/2.5 mg (OXN 5/2.5) and 20/10 mg (OXN 20/10) in Chinese~     patients with moderate to severe chronic non-malignant pain.~   "
52446|NCT02880462|"~     The goal of the study is to investigate whether adding different doses of sulforaphane will~     benefit the clinical symptoms and cognitive function in individuals who have schizophrenia.~      This study will compare the sulforaphane with placebo. There is a thirty percent change (less~     than half) of receiving the placebo. The purpose of including placebo is to judge if the~     outcome is related to the study medication rather than other reasons.~   "
52902|NCT02874508|"~     To analyze whether non-cardiac surgery in high-risk cardio-vascular patients induces a~     quantitative change in one or several leukocyte subpopulations and whether such changes are~     associated with perioperative cardio-vascular events.~   "
52448|NCT02880436|"~     Besides classical cardiovascular risk factors such as smoking, obesity, elevated cholesterol~     levels and diabetes there are also acute factors potentially triggering acute coronary~     events. The impact of various substances and air pollution are described.~      Particulate matter, especially with small particle size (<2.5µm) has been shown to have a~     positive correlation with myocardial infarctions. However, other studies failed to show this~     correlation.~      With respect to nitric oxydes the majority of published studies detected a significant~     correlation with myocardial infarction, too, although a highly ranked publication failed to~     show the same result. In addition data on the impact of sulfur dioxide and carbon monoxide~     concentration on cardiac events is very heterogeneous.~      Published data indicates additive effects of age and other epidemiological variables~     suggesting the need of a multivariate analysis.~      The rationale of the study is to test if the above mentioned air pollution factors have a~     significant and independent impact on the incidence of myocardial infarctions~   "
52449|NCT02880423|"~     Based on the accumulated literature, salpingectomy may significantly reduce the risk for~     ovarian cancer. If investigators can prove that there is no increase in surgical~     complications and morbidity during salpingectomy in CS, compared to tubal ligation,~     investigators can recommend for women who are interested in sterilization- salpingectomy~     during cesarean section .~   "
52450|NCT02880410|"~     Multicenter, open-label, prospective designed study to characterize the performance of brain~     laser interstitial thermal therapy (LITT) ablation using the Monteris NeuroBlate System in~     combination with standard of care radiation therapy and temozolomide for the treatment of~     newly diagnosed glioblastomas (GBM).~   "
52451|NCT02880397|"~     A single-center, randomized controlled clinical trial was done to assess the periodontal~     status of the individuals and the presence of red complex microorganisms (RCM) such as~     Treponema denticola, Porphyromonas.gingivalis and Tannerella.forsythia in the subgingival~     tissues of periodontal pockets at baseline followed by the application of mangostana gel as~     an adjunct to scaling and root planing. The periodontal parameters and RCM were again~     assessed at 3rd month and compared with the placebo group.~   "
52452|NCT02880384|"~     Study to compare the number of community-acquired pneumonia (CAP) pathogens detected using~     current diagnostic tests to the number detected using the BioFire Diagnostics investigational~     polymerase chain reaction (PCR) platform.~   "
52453|NCT02880371|"~     This is an open-label, multicenter Phase 1b/2 study to determine the maximum tolerated dose~     (MTD) and/or recommended Phase 2 dose (RP2D) of ARRY-382 in combination with pembrolizumab in~     adult patients with selected advanced solid tumors (Part A/Phase 1b); and to estimate the~     efficacy of the combination in three separate cohorts: 1) patients with advanced solid tumors~     that have progressed on prior PD-1/PD-L1inhibitors, 2) patients with platinum-resistant~     ovarian cancer and 3) patients with pancreatic ductal adenocarcinoma (Phase 2).~   "
52454|NCT02880358|"~     EPICAL 2 (Epidemiology and prognostic of the Acute Heart Failure) is an epidemiological,~     observational, prospective and multicenter study. This study includes at first an exhaustive~     recording of the cases on a geographic area at East of France, then the recorded patients are~     followed up in a cohort at least 3 years. This study follows the experiences of the EPICAL~     study led by our team.~      Main objective: To describe the characteristics of the patients affected by acute heart~     failure and to identify prognostic factors, in particular related to care. More exactly :~        -  To describe the sociodemographic, clinical, biological and therapeutic characteristics~          of the patients presenting an acute heart failure during hospitalisation and living at~          East of France ;~        -  To study the short and medium-term morbi-mortality of these patients, and identify the~          main factors determining the prognosis for survival ;~        -  To evaluate the prognostic impact of the intra and extra-hospital care ;~        -  To identify the evolution of the care's practices of the decompensated heart failure~          since the EPICAL study (15 years) and their influence on the prognosis of the disease.~      Secondary objective: to constitute a biological collection of serum, plasma and urine of~     patients' sample presenting an acute heart failure.~   "
52455|NCT02880345|"~     This is a pilot study of a fixed dose of Pembrolizumab in combination with two different~     regimens of hypofractionated radiation. It is designed to demonstrate the activity and safety~     of the combination treatment in advanced urothelial cancer patients with prior exposure to~     PD-1 inhibitors.~   "
52456|NCT02880332|"~     The primary scientific objective of the study entails examining whether altered endogenous~     pain inhibition is present in children with functional abdominal pain (FAP) and irritable~     bowel syndrome (IBS) compared with healthy controls (Part 1). A secondary objective implies~     examining whether pediatric pain neuroscience education (PNE) is able to improve pain~     catastrophizing, pain-related fear, pain intensity (including symptoms and indices of central~     sensitization) and pain-related functional disability in children with FAP or IBS (Part 2).~   "
52457|NCT02880319|"~     This research study is studying a form of radiation therapy called stereotactic body~     radiation therapy or SBRT as a possible treatment for Cancer that has spread to the spine or~     other bone~   "
52458|NCT02880306|"~     Rheumatoid arthritis(RA) is a disorder with altered immunologic function and increased risk~     of developing malignancies, while studies examining the association between hepatocellular~     carcinoma (HCC) and RA remain lacking. The investigators aimed to investigate the risk of HCC~     between participants with and without RA.~   "
52459|NCT02880293|"~     This study will test whether half matched donors with favorable KIR genes will reduce the~     risk of cancer recurring after transplant.~   "
52460|NCT02880280|"~     Observe the therapeutic efficacy of human menopausal gonadotropin combining with human~     chorionic gonadotropin in adolescent boys with congenital hypogonadotropic hypogonadism.~   "
52472|NCT02880111|"~     Rates of DMBT1 (Glycoprotein like) in Sputum of CF Patients with or without may be different~     according to their Pseudomonas Aeruginosa chronic colonization status. The aim of this study~     is to compare rates of DMBT1 (Glycoprotein like) in Sputum of CF patients with or without a~     Pseudomonas Aeruginosa chronic colonization.~   "
52473|NCT02880098|"~     Troponin T-us is a cardiac marker for myocardial infarction. Its use in neonates is~     increasing, yet normal values are still to be determined for the latest generation of tests,~     such as High sensitivity cardiac troponin T test. This study is an observational study~     designed to determine biological normal values of High sensitivity cardiac troponin T test~     (troponin T -us) in newborns.~   "
52461|NCT02880254|"~     Kurbo is a health and fitness app that is targeted toward the pediatric population. It~     utilizes games and activities to educate children about healthy eating, portion control/size~     and exercise. It allows for food tracking by using servings of macronutrients and food groups~     and sets goals for achieving a healthy BMI through modification of diet intake. In addition~     to being created solely for children and adolescents, a unique feature of this app is an~     option to speak with a personal health coach on a regular basis to obtain feedback, advice~     and encouragement. Studies suggest that weight loss outcomes are best with more frequent~     contact hours but most weight loss clinics, including ours, are not equipped to meet with~     patients on a weekly basis or even monthly basis. The personal coaching aspect of Kurbo is~     expected to improve outcomes by increasing user access to feedback and advice.~      The purpose of this pilot study is to assess the feasibility, compliance with and effects of~     a pediatric centered weight loss app on BMI z-scores in a group of children and adolescents~     in a pediatric weight management program. The investigators will assess the impact of the app~     as an adjunct to current weight management therapy, both with and without the personal health~     coach (PHC) option.~   "
52462|NCT02880241|"~     The present proof-of-concept Phase IIa study aims to confirm, in patients, the observed~     activity of MMV390048 against P. falciparum in pre-clinical models and the human Induced~     Blood-Stage Malaria (IBSM) challenge model, and to determine the activity against P. vivax~     malaria in patients, both over 14 and 28 days. Additional aims are to characterise the safety~     of MMV390048 in patients. Patient safety will be monitored for up to 35 days post-dose~     including pharmacokinetic assessments. The study will investigate descending single doses of~     MMV390048 in response to results obtained in the first cohort/dose in each malaria sub-type.~     The results of this trial will identify active, well-tolerated doses for investigation in~     combination with a partner drug within a Phase IIb clinical trial.~   "
52463|NCT02880228|"~     This phase II trial studies how well pembrolizumab, lenalidomide, and dexamethasone work in~     treating patients with newly diagnosed multiple myeloma that are eligible for stem cell~     transplant. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of~     cancer cells to grow and spread. Drugs used in chemotherapy, such as lenalidomide and~     dexamethasone, work in different ways to stop the growth of cancer cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. Giving~     pembrolizumab, lenalidomide, and dexamethasone may work better in treating patients with~     multiple myeloma.~   "
52464|NCT02880215|"~     Although negatively biased attention has a central theoretical and empirical role in the~     maintenance of depression, there are few behavioral treatments that successfully target and~     improve this deficit. The current proposal builds upon prior work and aims to further develop~     an attention bias modification intervention. The investigators propose to develop a highly~     specific intervention that directly targets negative attention bias and the neurobiology that~     supports it, using cutting-edge cognitive neuroscience to inform treatment development and~     improve quality of life of patients whose psychopathology is maintained by negative attention~     bias.~   "
52465|NCT02880202|"~     This is a pilot study to evaluate the impact of massage therapy in hospice patients.~   "
52466|NCT02880189|"~     This study is designed to investigate the impact of weight loss achieved with the IGB on NASH~     with early fibrosis in a select cohort of patients with obesity preselected to have a high~     pre-test probability of having NASH with early fibrosis based on MRE-Hepatogram. In addition,~     this study will explore potential non-invasive imaging criteria for NASH and early fibrosis~     using EUS-Elastography.~   "
52467|NCT02880176|"~     Radical cystectomy with urinary diversion is associated with substantial perioperative~     morbidity, including deep venous thrombosis, prolonged ileus, and postoperative functional~     decline. Post-operative morbidity after cystectomy prolongs the length of stay, increases the~     risk of readmission, and adds substantially to health care costs. Protocols that emphasize~     early and frequent ambulation after surgery decreases post-operative morbidity, but poor~     patient adherence diminishes the effectiveness of these protocols, which are currently~     implemented only during the hospital stay. Financial incentives overcome present bias and~     offer a novel and practical approach to increasing ambulation during the post-operative~     period in the hospital and also after discharge. This application proposes a pilot~     randomized, controlled trial to estimate the effect size of financial incentives on achieving~     a patient-specific daily step goal in the hospital and post-discharge for 1 month following~     radical cystectomy. Secondary outcomes include step count, composite morbidity, and~     functional decline. Forty-six adults with bladder cancer undergoing radical cystectomy at the~     Hospital of the University of Pennsylvania will be randomized to either control (education of~     step goal with monitoring and daily feedback) or a gain financial incentive combined with a~     lottery incentive if they achieve 75% of the daily goals during the study period. Fitbit Zips~     will be used to measure step counts for all participants. This proposal will provide the~     preliminary data needed to design future, larger trials that will test the effect of~     financial incentives to increase ambulation on post operative complications, readmissions,~     and functional decline.~   "
52468|NCT02880163|"~     The purpose of this study is to demonstrate safety, effectiveness and benefit‐risk profile of~     ResQFoam for the inhospital treatment of exsanguinating, intraabdominal haemorrhage due to~     trauma in patients where emergent laparotomy is required.~   "
52469|NCT02880150|"~     Climbing at high altitude and tolerating hypoxic environment require specific physiological~     adaptations. Large intersubjects differences exist regarding the ability to adapt to high~     altitude and hypoxia. The present study aims to characterise the physiological responses to~     hypoxia in a group of elite climbers by comparison to sea level athletes. We hypothesised~     that elite climbers would show better physiological responses to hypoxia and more preserved~     performances compared to sea level.~   "
52470|NCT02880137|"~     Is real-time myocardial perfusion echocardiography (RTMPE) a feasible and effective~     non-invasive method to detect significant Coronary Allograft Vasculopathy in pediatric and~     adult cardiac transplant recipients? Will perfusion deficits correlate with significant~     coronary artery stenosis identified by standard stress echocardiography and Invasive Coronary~     Angiography (ICA), and identify diffuse small vessel disease more effectively than current~     non-invasive techniques?~   "
52471|NCT02880124|"~     The purpose of this study is to compare the acute metabolic responses and time-trial~     performance following the ingestion of carbohydrate solutions containing either maple syrup,~     maple sap, corn syrup, a commercial sport drink or water.~   "
52474|NCT02880085|"~     The diagnostic gold standard to differentiate FAI (femural acetabular impingement) from other~     muscular-tendinous pathologies is, actually, the injection of intra-articular anesthetic~     (lidocaine), with a pre- and post- evaluation of pain scale.~      If, after injection, the pain disappears, the pain is probably due to an articular problem~     (FAI). This kind of differential diagnosis test has a sensibility of 100% and a specificity~     of 81%.~      C-terminal telopeptide of type II collagen (CTXII) as cartilage degradation index, could be a~     marker, simply detectable, to assess the healthy of the cartilage status and could be~     measured in serum and urine.~   "
52475|NCT02880072|"~     A phosphate supplement is part of the treatment of patients with the refeeding syndrome~     (RFS). It is not known, if the generalized edema also affects the intestine to decrease~     absorption. The aim was to investigate, if oral treatment is possible in mild to moderate~     RFS. In a randomized crossover design 12 hospitalized head-neck cancer patients ingested four~     oral solutions of phosphate in two-day periods. In a low-dose period the investigators~     compared five mmol phosphate from either skimmed milk or Di-sodiumphosphate-di-hydrate and~     potassium di-hydrogens-phosphate with black currant flavor (PBC), and in a high-dose period~     20 mmol from either Addiphos® or the PBC-solution. P-phosphate was measured two and four~     hours after the ingestion, the urinary excretion after four hours.~      P-phosphate significantly increased after PBC in both the low- and high-dose and Addiphos®,~     but not after skimmed milk. The increase was larger after Addiphos® than the PBC-solution.~     There was no difference in the increase between the patients with low p-phosphate and those~     with normal values, and no correlation between baseline p-phosphate and percent increase.~     There was no group difference in the urinary excretion of phosphate. The investigators~     conclude that phosphate can be readily absorbed after oral administration, but skimmed milk~     can´t be recommend for this purpose.~   "
52476|NCT02880059|"~     Patients with intracerebral aneurysm will be screened for sleep apnea using out of center~     polysomnography/polygraphy. Baseline blood pressure and medication will be assessed. Patients~     will be followed for up to 5 years to examine the increase in aneurysm size, rupture rate and~     changes in medication.~   "
52477|NCT02880046|"~     Purposes of this study are :~        -  Characterization of polyfunctionality of anti-tumor T lymphocytes using in vitro~          inhibition of PD-1/PDL-1 pathway~        -  Study and comparison of polyfunctionality of anti-tumor T lymphocytes in cohorts of~          patients with melanoma, lung cancer and renal carcinoma. This cancers are chosen because~          of use of anti-PD-1 or anti-PDL-1 antibodies~        -  Comparison of this technique with IFN-γ Elispot assay for detection and quantification~          of anti-tumor T lymphocytes after in vitro blockade of PD-1/PDL-1 pathway.~   "
52478|NCT02880033|"~     Peripheral blood mononuclear cells (PBMC) and platelets could be interesting ex vivo models~     to study brain diseases. Indeed, there is no access to neurons from patients. However, PBMC~     can exhibit different physiopathological mechanisms that are ubiquitous (i.e. oxidative~     stress, mitochondriopathy with energy metabolism, inflammation, protein folding, iron~     metabolism and programmed cell death ...). The platelets are pivotal in the healing system~     with large range of growth factors. A new therapeutic concept of conservative iron chelation~     with deferiprone for neuroprotection is under development.~      The action of deferiprone on the different mechanisms and notably the oxidative stress are to~     obtain from a collection of PBMC and platelets from patient having Parkinson's disease and~     Amyotrophic lateral sclerosis and healthy controls to study ex vivo.~      PBMC and platelets will be stored for future analyses.~   "
52479|NCT02880020|"~     This randomized phase II trial studies how well nivolumab with or without ipilimumab works in~     treating patients with gastrointestinal stromal tumor that has spread to other places in the~     body or cannot be removed by surgery. Monoclonal antibodies, such as nivolumab and~     ipilimumab, interfere with the ability of tumor cells to grow and spread.~   "
52480|NCT02880007|"~     This prospective phase II trial study aims to optimize the increase in dose to the target~     volume at high risk (85 to 90 Gy over 90% of its volume) and the intermediate target volume~     (60 Gy to 90 % of its volume) in 3D Pulsed Dose Rate Brachytherapy in treating patients with~     locally advanced cervical cancer.~   "
52481|NCT02879994|"~     This phase II trial studies how well pembrolizumab works in treating patients with epidermal~     growth factor receptor (EGFR) mutant non-small cell lung cancer that have not received prior~     tyrosine kinase inhibitor therapy and has spread to other places in the body. Monoclonal~     antibodies, such as pembrolizumab, may block growth in different ways by targeting certain~     cells.~   "
52482|NCT02879981|"~     This pilot, multicentric and observational study will assess the safety of sulfamethoxazole +~     trimethoprim + guaifenesin (Balsamic Bactrim) in pediatric participants with acute~     bronchitis. Administration of treatment will be according to treating physician's~     recommendation under local labeling.~   "
52483|NCT02879968|"~     Correlation between serum squamous cell carcinoma antigen level and tumor volume in Head and~     Neck Cancer is to determine a correlation between level of serum squamous cell carcinoma~     antigen and tumor volume in Head and Neck Caner measured by cross-sectional imaging.~   "
52484|NCT02879955|"~     To investigate the secretion of gut hormones, in particular glucagon-like peptide 1 (GLP-1),~     after ingestion of glucose and fructose as separate monosaccharides or combined in the~     disaccharides sucrose and isomaltulose and the effect of acarbose in gastric bypass operated~     subjects and BMI-matched controls.~   "
52485|NCT02879942|"~     Preeclampsia (PE) and intrauterine growth restriction (IUGR) are clinical manifestations of~     placental insufficiency. These complications affect 5-15% of pregnancies, and are responsible~     for up to 20% of preterm births. Women who develop PE during pregnancy also have an increased~     risk for cardiovascular events, both at short and long term. This justifies the need to~     improve diagnostic tools to identify patients at risk for these complications. PE and IUGR~     are multifactorial entities. Screening algorithms should thus include several parameters to~     achieve high detection rates. Research has mainly focused in the analysis of biophysical and~     biochemical parameters, and the study of the placenta itself has not been included in current~     diagnostic strategies. Investigators hypothesize that detection rates of preeclampsia and~     intrauterine growth restriction could be improved by the study of placental characteristics~     in the first trimester of pregnancy.~   "
53577|NCT02865681|"~     The purpose of the study is to evaluate the safety and efficacy of nasal gonadotropins~     (Menopur) in women undergoing IVF. The purpose of this study is also to report and monitor~     any and all side effects of the nasal Menopur.~   "
52486|NCT02879929|"~     Nasal symptoms are the main elements that lead to a therapeutic decision and allow for~     evaluating treatment effects or natural evolution. Despite availability of several~     questionnaires with good measurement qualities, no systematic assessment takes into account~     the specific physical and psychosocial consequences of each of the six main nasal symptoms,~     independently of the disease. The study proposed to measure these symptoms with the use of a~     selfreport questionnaire and to test the validity of the questionnaire in a large~     representative sample of patients attending outpatient rhinologic clinics.~   "
52487|NCT02879916|"~     This study describes the difference of analgesic effect of levobupivacaine 0.5% administered~     through an interscalene nerve block with or without a stellate ganglion block. The length of~     the analgesic effect is our primary outcome parameter. Half of the recruited patients will~     receive a stellate ganglion block and half of the patients won't.~   "
52488|NCT02879903|"~     The aims of the present study will be identify 5 types of fimbrial subunit genotype strains~     in smokers and nonsmokers with periodontitis, before and after periodontal therapy. Third two~     periodontitis patients will be selected to these study, 16 nonsmokers and 16 smokers.~     Clinical and microbiological parameters were evaluated at baseline and 3 months after~     periodontal treatment: Plaque Index, Bleeding On Probe, Probing Depth, Gingival Recession and~     Clinical Attachment Level. The prevalence of P. gingivalis and fimbrial subunit gene strains~     will be determined by Polymerase Chain Reaction.~   "
52489|NCT02879890|"~     National cohort study aimed to investigate the impact of comorbidities (number and type of~     comorbidities) on health utility state change in lower lim osteoarthritis (hip and knee OA).~   "
52490|NCT02879877|"~     This study is designed to evaluate the safety and tolerability of UCB7858 when given as~     single ascending doses administered by intravenous or subcutaneous infusion in healthy~     subjects.~   "
52491|NCT02879864|"~     Fatigue is a symptom most commonly associated with the diagnosis of cancer. Fatigue often~     appears before the diagnosis of cancer, is increasing during treatment with chemotherapy and~     persists for years after treatment in more than 35% of patients. Fatigue is the earliest and~     most important symptom described by cancer patients. Its prevalence in cancer chemotherapy~     patients is between 70 and 100%. Fatigue is more common to cancer patients and to the general~     population or other types of patients. Typically described as a lack of energy associated~     with mental disorders, fatigue related to cancer can be extremely debilitating. The causes~     are many, mainly including the cancer itself, side effects due to treatment, sleeplessness~     due to pain, anxiety or depression. The cancer-related fatigue has a negative and significant~     direct impact on all aspects of the patient's quality of life, especially the physical,~     social and behavioral. Despite the availability of certain treatments and the advanced~     biomedical research, fatigue remains an inevitable consequence of cancer and its treatment.~      The therapeutic use of natural light in medicine dates back to the late nineteenth century.~     Its remarkable effect on the stimulation of the immune system and fight against infections~     caused the development of the first therapy techniques (also called luxthérapie) awarded in~     1903 by the Nobel Prize in medicine and physiology. Light plays a fundamental role in the~     regulation of circadian rhythms and homeostatic. The mechanism of action passes through a~     path non-visual involving melanopsin ganglion cells located in the retina. Activation of~     the pineal gland (epiphysis) by melanopsin cells allows transduce information shadow and~     light in melatonin synthesis from serotonin. Today, the effectiveness of the therapy is well~     established for treating fatigue-related disorders such as chronic fatigue, seasonal~     depression or seasonal or non-certain sleep disorders and in which the melatonin metabolism~     is disturbed. Light therapy, by its mechanism of action, allows reprogramming of the~     biological clock and improved synchronization of circadian rhythms.~   "
52492|NCT02879851|"~     The study aims at quantifying the registration error obtained in routine patients in~     different parts of the prostate and for operators with different experience in order to~     assess the average precision of the elastic MR-ultrasound fusion obtained by Koelis™ system.~      Patients referred for placement of intraprostatic fiducials before radiotherapy for prostate~     cancer will be prospectively offered to enter the study.~      The fiducials will be placed under transrectal ultrasound guidance, in the prostate apex,~     midgland and base, according to our routine procedure. A 3D Ultrasound acquisition of the~     prostate will be obtained at the end of the placement. As per our routine procedure, patients~     will undergo unenhanced prostate MRI to control the position of the fiducials. An elastic~     fusion of the MR images and the 3D ultrasound acquisitions will be retrospectively performed~     by operators of varying experience using the Koelis system. The fiducials (visible on MR and~     ultrasound images) will be used to quantify the registration error.~   "
52493|NCT02879838|"~     The purpose is to compare clinical, functional, professional and socio-economical~     characteristics of patients with occupational asthma and work aggravated asthma.~      Secondary purposes are:~        -  to evaluate diagnostic value of new non-invasive techniques such as exhaled nitric oxide~          and cytology of induced expectoration;~        -  to estimate medical-social becoming of diagnosed work-related asthma after one year;~        -  to establish a biobank of blood samples of individuals with work related asthma for~          measurement of cytokines and search for genetic polymorphisms associated with asthma.~   "
52494|NCT02879825|"~     Mitral valve prolapse (MVP) is a frequent affection of the mitral valve or its sub-valvular~     apparatus with a prevalence of 2-3% in the general population. This valvular disease is~     generally considered as benign, but may at term evolve toward mitral valve regurgitation of~     various severity and/or arrhythmia.~      Mitral valve prolapse is routinely diagnosed using transthoracic echocardiography and only~     patients with significant mitral regurgitation will undergo subsequent examination (24-hour~     external loop recording, exercise ECG, cardiac MRI) and a close follow-up.~      External loop recording and exercise ECG have an interest in the identification of patients~     presenting with arrhythmic complications, such as premature ventricular contractions, and in~     the global evaluation of hemodynamic consequences of the mitral regurgitation.~      More recently, detection of myocardial fibrosis among patients with MVP and severe~     ventricular arrhythmia has been identified. Fibrosis could evolve independently of the~     valvular regurgitation's severity and could be a substrate (myocardial scar) leading to~     ventricular arrhythmia. However, no study has specifically characterized myocardial lesions~     among patients with MVP and none, or not significant, mitral regurgitation. Using cardiac~     magnetic resonance imaging (MRI), gold standard technique in myocardial imaging and~     characterization, and echocardiography, particularly speckle-tracking imaging, identification~     of static (fibrosis) and/or dynamic (ventricular systolic deformation patterns using~     speckle-tracking strain) myocardial lesions.~      Identification of patients with impaired deformation patterns, fibrosis or with premature~     ventricular contractions may isolate a sub-group of patients with a higher risk of severe~     ventricular arrhythmia for whom a closer follow-up could be justified.~   "
53578|NCT02865668|"~     The purpose of this study is to evaluate bioequivalence of the metformin component of the~     Fixed Dose Combination (FDC) tablet compared with the metformin Extended Release (XR) tablet~     coadministered with canagliflozin in healthy fed and fasted participants.~   "
52495|NCT02879812|"~     The purpose of the current study is to test a systems-level approach to disseminate a~     multicomponent, multilevel intervention consisting of educational materials about~     transplantation and the new kidney allocation system targeting dialysis facility Medical~     Directors, staff, and patients. Roughly 750 dialysis facilities in up to 18 end stage renal~     disease Network regions across the United States will be randomized to receive intervention~     materials. The overall goal of the study is to extend the influence of the national~     allocation policy in reducing disparities in early steps in kidney transplant access.~   "
52496|NCT02879799|"~     In Alberta, nearly one in every twelve babies is born too soon (preterm). Preterm babies are~     at greater risk for breathing and feeding problems, as well as infections, than babies born~     on their due date (full term). As a result, parents must leave their preterm babies in the~     hospital to fully develop and become healthy enough to take home. When it is time for~     discharge, parents are often not ready to look after their baby because they may have limited~     involvement in the care of their baby in hospital. In addition to the distress and costs to~     parents of having a baby in hospital, health system costs are also increased the longer a~     baby is in hospital. The purpose of this project is to test a new way to integrate parents~     into the care of their baby through a program called Family Integrated Care (FICare). In~     FICare, parents are educated and supported by nurses to provide care for their baby; nurses~     and doctors still provide intravenous medications and medical procedures. FICare has been~     tested in Ontario and shows promise as a better model of care for the small percentage of~     babies born more than 8 weeks early, who have to spend a long time in hospital.~      Now the investigators want to test FICare with the greater percentage of preterm babies who~     are born 4 to 8 weeks early to see if parents are able to take their baby home sooner, and if~     their babies are healthier. The investigators also want to know if FICare can reduce distress~     for parents. The investigators propose to test FICare in Level II Neonatal Intensive Care~     Units (NICUs) in Alberta by implementing FICare in half the Level II NICUs and comparing the~     outcomes with the other Level II NICUs who do not use FICare. If FICare improves outcomes for~     preterm babies and their parents, the investigators will implement it in all Level II NICUs.~     In Alberta, the investigators want the best quality care for our most vulnerable babies and~     their parents. This project is aligned with Alberta's Health Research and Innovation Strategy~     priority of wellness at every age (child and maternal health), and with Alberta Health~     Services' quality of care goals to increase efficiency, effectiveness, appropriateness, and~     acceptability of health care services delivery.~   "
52497|NCT02879786|"~     The purpose is to determine the hierarchy of sensory afferents according to different forms~     of dyslexia in children.~      The secondary purpose is to determine sensitive and sufficiently specific posturographic~     indexes for standard diagnosis of different types of dyslexia.~   "
52498|NCT02879773|"~     This study uses CT scans to assess airflow in the lung, the scan is quick, cheap and~     painless. The information from the scan may help doctors tell which patients are suitable to~     have surgery to cure early stage lung cancer. It may also help doctors tell which patients~     would benefit from surgery for emphysema and diagnose types of lung disease. The~     investigators will follow up patients who go through surgery to test how well the scan~     predicts the function of the lung after surgery. The investigators will follow patients being~     investigated for lung disease to test how accurate the scan is at the getting the diagnosis~     right.~   "
52499|NCT02879760|"~     This is a Phase 1/2, multi-center, open-label, dose-escalation trial of Ad-MAGEA3 and~     MG1-MAGEA3 in combination with pembrolizumab in patients with Non-Small Cell Lung Cancer who~     have completed a first standard therapy with at least 1 cycle of platinum based chemotherapy~     and/or at least one treatment of PD-1 or PD-L1 antibody targeted therapy.~   "
52500|NCT02879747|"~     The objective was to study whether normal growth velocity can be maintained with adapted GH~     dosage in GH treated prepubertal children who have responded to GH treatment with fulfilled~     catch up growth (=difference to target height reached, less than - 0.6 SDS).~   "
52501|NCT02879734|"~     The purpose of this study is to compare function of the peritoneal dialysis catheter in two~     groups of patients with and without prophylactic omentopexy that was performed during~     laparoscopic insertion of peritoneal catheters.~   "
52502|NCT02879721|"~     Barrett`s esophagus (BE) is the major esophageal pre-neoplastic lesion in which dysplastic~     transformations eventually can lead to cancer development. Today, the only way for early~     detection of pre-neoplastic lesions is an endoscopic surveillance programme with tissue~     sampling for histopathology, the latter being the only validated biomarker for esophageal~     adenocarcinoma (EAC)-risk available. New biomarkers are warranted for better patient~     selection before inclusion into BE surveillance programmes.~      Epidemiologic studies have demonstrated suppressed numbers of cancer prevalence in cohorts~     being under different medical treatment. In a British epidemiological study 2007 Sjöberg et~     al noted a lower prevalence of EAC among patients treated with antihypertensive drugs~     interfering with the renin-angiotensin system (RAS) such as AT1R-blockers and ACE-inhibitors.~     The last decade this endocrine signalling system has been proven to be involved in~     pathological conditions such as inflammation, wound-healing and even cancer, in several organ~     systems.~      Earlier reports from the investigators laboratory indicate the existence of a local RAS in~     the esophageal wall musculature and in the squamous mucosa. In the investigators latest~     explorative study, the investigators discovered the altered expression of classical RAS~     components in BE with and without dysplasia (unpublished results).~      By a possible alteration in RAS-related protein-expression in BE with increasing grade of~     dysplasia towards EAC, the investigator may have a possible pathway leading to biomarkers~     for cancer-development. Furthermore, the already well-known anti-hypertensive drugs~     ACE-inhibitors and AT1R-blockers may interfere with the risk of malignancy in BE. The~     investigators therefore wish to test, in an exploratory prospective randomized~     placebo-controlled setting, whether RAS-related protein-expressions in BE are altered by the~     addition of RAS-suppressant pharmaceuticals. In the same manner the investigators wish to see~     if the expressions of well-known biomarkers for cancer and inflammation are altered.~   "
52503|NCT02879708|"~     In several low and middle-income countries, Social Accountability (SA) interventions have~     been introduced as an innovative approach to governance, aiming to improve delivery of public~     services. These interventions typically include information provision to citizens regarding~     their rights/entitlements and local provider performance, and additionally, facilitation of~     community engagement with providers and officials.~      The state government of Uttar Pradesh (UP) and the Uttar Pradesh Health Systems Strengthening~     Project (UPHSSP) have identified 12 districts where the social accountability initiative will~     be introduced on a priority basis. This study focuses on interventions in 2 of these~     districts (Sultanpur and Fatehpur), to study mechanisms through which information and~     collective action lead to improved accountability and outcomes. Within the 2 districts, the~     study is implemented as a cluster randomized evaluation with 120 villages randomized into 2~     treatment arms and one control arm.~      This study aims to: (a) measure the causal effect of SA interventions on key outcomes (health~     status, quality of service); (b) test the effectiveness of social networks based strategies~     to disseminate information for community engagement; and (c) study individuals' decisions to~     participate in collective action efforts in the context of social networks and information~     interventions. In addition to evaluating the impact of the SA interventions, the study aims~     to generate new knowledge on relative strengths of information seeding strategies,~     identifying those that maximize the spread of information through the village network, and~     subsequently estimate peer effects on participation decisions.~   "
52548|NCT02879123|"~     This trial aims at collecting standardized data concerning the early neurological clinical~     recovery of patients, 3 months after endovascular treatment of an acute ischemic stroke.~      Although this outcome is a major issue of patients' prognosis, it is rarely collected at this~     stage of their follow-up.~   "
52506|NCT02879669|"~     The trial is an open-label, parallel group, multicentre trial that will recruit a total of 30~     patients with malignant pleural mesothelioma. The trial will be conducted in 2 phases: a~     non-randomised safety phase and a randomised phase. The safety phase will consist of a~     lead-in cohort of 6 patients treated with ONCOS 102 and pemetrexed/cisplatin. The randomised~     phase will not commence until the DSMB has deemed the safety lead-in data appropriate for~     continuation. A total of 24 patients will be included in the randomised phase; 14 patients~     will be randomised to receive ONCOS 102 and pemetrexed/cisplatin, and 10 patients will~     receive pemetrexed/cisplatin alone. The trial's main objectives are determination of safety,~     immune activation, clinical response and the correlation between clinical outcome and the~     immunological data.~   "
52507|NCT02879656|"~     The present collaboration study on the treatment of distal radius fractures is aimed to:~      (i) to compare the functional outcome in patient rated wrist evaluation (PRWE) score after~     closed reduction and cast immobilization and operative treatment with volar locking plate in~     the initial treatment of primarily unstable, non-reducible distal radius fractures in~     patients over 64 years.~      (ii) to compare the functional outcome in PRWE score after closed reduction and cast~     immobilization and operative treatment with volar locking plate in the treatment distal~     radius fractures with early instability during follow-up, ie. loss of reduction at one week~     (5 to 10 days) in patients over 64 years.~      (iii) to compare pain, disability, quality of life, grip strength and the number of~     complications and the effect of pain catastrophizing score (PCS) after conservative treatment~     and initial and postponed operative treatment of the distal radius.~      (iv) to assess the need and number of follow-up visits required, if any, after treatment of~     distal radius fractures.~   "
52508|NCT02879643|"~     This is a pilot study utilizing Marqibo® (vincristine sulfate liposome injection) combined~     with dexamethasone, mitoxantrone and asparaginase (UK ALL R3) for relapsed acute~     lymphoblastic leukemia (ALL).~   "
52509|NCT02879630|"~     Patients receiving acyclovir as standard of care will be enrolled into this study. The~     currently recommended dosing strategy at our institution for obese patients is to receive~     intravenous acyclovir dosed per an adjusted body weight [IBW + 0.4(TBW-IBW)]. They will have~     blood drawn once prior to the first dose of acyclovir and 10 times thereafter, over a total~     time period of 12 hours. These patients will already be hospitalized for other reasons, and~     will not be required to make additional trips to the hospital. A total of approximately 4-5~     tablespoons of blood will be drawn for this study. Ten obese patients and 10 matched control~     (non-obese) patients will be enrolled.~   "
52510|NCT02879617|"~     This is a single-arm phase II clinical trial evaluating the safety and efficacy of the PD-L1~     inhibitor durvalumab as first-line therapy in 50 patients with advanced NSCLC and ECOG~     Performance Status 2 (PS2).~   "
52511|NCT02879604|"~     Significant cognitive impairment (executive functions, memory, attention) is common in~     schizophrenia affecting up to 80% of patients. But pharmacological treatments (typical and~     atypical antipsychotic) do not have impact on cognitive functioning. For over 20 years,~     alternative non-pharmacological therapeutics have been developed in schizophrenia. These~     techniques called cognitive remediation specifically target cognitive deficits. The first~     cognitive remediation available for patients was designed to stimulate new learning, or~     relearning, of cognitive tasks, and thus to improve certain deficient domains. These~     procedures were efficient in improving cognition as measured by neurocognitive tests but~     their impact on functioning and daily life was weak. In a second time, compensatory~     remediation has been developed. Compensatory approaches seek to make improvements in the~     patient's functioning by avoiding areas of impairment and recruiting other intact cognitive~     domains or by creating a supportive external environment. In recent meta-analysis~     compensatory remediation has larger effect-size than classical cognitive remediation, with an~     impact on patients psychosocial functioning. Recently, Dr E. Twamley (University of~     California) developed and tested a group-based, manualized, compensatory cognitive training~     intervention.~      Compensatory cognitive training (CCT) is a low-tech, brief intervention and is easily~     transposable in community care. Our team translated this method into French. The~     investigators planned a cost -utility study between CCT and treatment as usual in~     schizophrenia patients with less than 10 years of evolution.~   "
52512|NCT02879591|"~     The objective of AlterEgo is the creation of an interactive cognitive architecture,~     implementable in various artificial agents, allowing a continuous interaction with patients~     suffering from social disorders, by virtue of changes in behavioural (robot-based) as well as~     morphological (avatar-based) properties of that agent. The project includes research in~     fundamental and clinical neurosciences, interaction modeling, development of new~     computer-vision techniques and human-robot interfaces, as well as evaluation of the scenarios~     with patients before, during, and after training sessions. At the end of the project, the~     investigators will produce a new avatar-based clinical method able to enhance social~     interaction of patients.~      The first challenge of this project is to create an avatar alter ego of a patient. Based on~     recent work in social robotics and neurosciences, the investigators hypothesize that if~     patients face artificial agents morphologically and behaviourally similar to them, they will~     increase their social interaction. The second challenge is to transform the morphology and~     the behaviour of the similar artificial agent into that of a healthy and different agent. The~     investigators assume that the smooth and continuous behavioural shift from similar/unhealthy~     to complementary/healthy social behaviour will lead to a better social rehabilitation.~     AlterEgo opens the door to a new generation of social artificial agents in service robotics.~     AlterEgo is an interdisciplinary project at the interaction of Social Motor Neurosciences~     (UM1), Robotics (EPFL), Complex Systems Dynamics (UOB), Computer Vision (DFKI), and~     Psychiatry (CHU).~      This project includes a set of experiments that started in april 2014 and will terminate in~     september 2016 before undergoing a randomised clinical research.~   "
52513|NCT02879578|"~     Phase 2, open-label, fixed-dose titration study to evaluate the safety and tolerability of~     NBI-98854 administered once daily for a total of 24 weeks in children, adolescents, and~     adults with Tourette Syndrome (TS).~   "
52564|NCT02878915|"~     Using ultrasound to guide vascular catheterism in children is highly recommended for central~     venous access. It has been proven that central venous line is inserted faster, with fewer~     attempts and complications. Its interest in central arterial line insertion is less obvious.~     It seems to have benefits in adults, both for radial and femoral arterial insertion. But~     there is no study assessing the interest of ultrasound guided arterial puncture in children,.~   "
52514|NCT02879565|"~     Progress in resuscitation has increased the chances of survival after anoxic or traumatic~     brain injury. More and more patients with severe cerebral damages are resuscitated but upon~     awakening from coma, some patients remain in a state which cannot be qualified as conscious~     and is now known as an unresponsive wakefulness syndrome (UWS; formerly known as vegetative~     state). This condition can be transitory and evolve towards recovery, or remain chronic and~     lasting for years.~      To improve the diagnosis of patients with disorders of consciousness, recent advances in~     brain imaging have led to the development of new methods of detecting awareness. In the~     absence of overt behavioral responses from these patients, imaging-based diagnostic methods~     have been first used to assess whether some cerebral areas were preserved in UWS patients and~     showed an activation of the primary sensory cortices in some UWS patients, whether it occurs~     at the auditory, visual or somatosensory level. Unavoidable technical and ethical issues are~     raised for clinicians before responding to such requests:~        1. Is it technically possible to generalize neuroimaging protocols to all healthcare~          institutions?~        2. Is it ethically acceptable to propose neuroimaging protocols without an accurate~          estimation of their psychological impact on families and caregivers?~      The present study aims to understand and anticipate the technical and ethical issues related~     to an evaluation of consciousness with functional neuroimaging. How the evaluation of~     awareness in a patient affects the caregivers and family members will be investigated. By~     using qualitative research hopes and expectations will be clarified through the experiences~     of families, clinicians and nurses faced to this situation.~      Will be included in this research professional caregivers and persons closely related to UWS~     patients:~        -  Family members or close circle visiting the patients on a regular basis~        -  Referring clinicians~        -  Nurses in charge of the patients' care~      This prospective study uses qualitative, interview-based, research. Two key-moments are~     explored in succession to examine the impact of a neuroimaging evaluation of consciousness in~     institutionalized UWS patients:~        -  interviews of professional caregivers and families about their hopes concerning the~          evaluation of consciousness of UWS patients,~        -  interviews of professional caregivers and families about the impact of evaluating~          consciousness on their beliefs~   "
52515|NCT02879552|"~     Increased tarsal platform show (TPS) and decreased brow fat span (BFS) are associated with~     favorable results in women undergoing cosmetic blepharoplasty. The authors evaluate the~     efficacy of a technique (brassiere sutures) to increase TPS and decrease the BFS.~   "
52516|NCT02879539|"~     Reducing power consumption in the cochlear implant is crucial to the development of future~     smaller sound processors. The commercial MP3000 sound coding strategy has been shown to be~     more efficient in power consumption to the standard ACE strategy. However in order to develop~     smaller sound processors, further battery life power savings are required. The aim of this~     study is to evaluate three experimental sets of MP3000 parameter sets, compared against the~     default ACE program. In the background for each of the four strategies, experimental noise~     reduction programs (SpatialNR and NR3) will also be in use. In an additional phase of the~     study, low stimulation rate ACE programs will also be evaluated against the default~     stimulation rate.~   "
52517|NCT02879526|"~     The purpose of this study is to investigate efficacy and safety of Chidamide Combined With~     Cyclophosphamide、Prednisone、Thalidomide in Treatment of Fragile Patients With~     Relapse/Refratory Peripheral T Cell Lymphoma :a Phase II,Single-arm,Open-label, Muti-center~     Study~   "
52518|NCT02879513|"~     This trial will compare the administration of 2 cycles of paclitaxel and cisplatin (DP)~     versus 4 cycles of CEF as adjuvant chemotherapy for the patients with locally advanced breast~     cancer and who were pathological partial response to DP as neoadjuvant chemotherapy. Those~     who had pathological complete response to DP will be randomized to have 2 cycles of DP or~     have no further chemotherapy.~   "
52519|NCT02879500|"~     Sugars have been singled out as one of the prime culprits in the dual epidemics of obesity~     and diabetes. Artificially sweetened beverages (ASBs) provide a potentially important means~     for displacing excess calories from free sugars in the diet. There is, however, a concern~     that the use of ASBs may themselves contribute to an increased risk of obesity and diabetes.~     This concern led the 2015 Dietary Guidelines for American Committee (DGAC) to recommend that~     sugars in the diet not be replaced with ASBs but rather with healthy options such as water.~     Whether ASBs more than water will contribute to obesity and diabetes remains unclear. To~     address this important question, the investigators propose to conduct a series of systematic~     review and meta-analyses of the totality of the evidence from randomized controlled trials~     and prospective cohort studies to evaluate the effects of water and ASBs in the development~     of overweight and obesity. The findings generated by this proposed knowledge synthesis will~     help improve the health of consumers through informing evidence/base guidelines and improving~     health outcomes by educating healthcare providers and patients, stimulating industry~     innovations, and guiding future research design.~   "
52520|NCT02879487|"~     The aim of this study is to assess a major complication of total laparoscopic hysterectomy,~     vaginal dehiscence, with two different colpotomy techniques. With this aim patients to be~     operated for laparoscopic hysterectomy will be randomized to two different techniques. The~     colpotomy will be undertaken by 'cut mode' in the first group and 'coagulation mode' in the~     second group. All of the operations will be preformed by the same surgical at a university~     hospital. Vaginal dehiscence after surgery is the primary outcome measure.~   "
52521|NCT02879474|"~     State of the question Over the past decade, the incidence of melanoma (MM) has steadily~     increased in France and in most developed countries. This increased incidence was concerned~     mainly MM thin while the incidence of MM thick that represent the true killers, and~     mortality from MM remained stable or increased slightly over the same period. These~     epidemiological data and observations from everyday medical practice dermatologists suggest~     the existence of different growth patterns within MM. Indeed, some MM progressing slowly~     sometimes for decades before diagnosis but are thin at the time of resection. Conversely,~     others MM grow very quickly, resulting in thick tumors despite a diagnosis and resection~     sometimes very early. These fast growing MM (FGMM) probably contribute significantly to the~     relative mortality in MM, as improved screening failed to influence to this day.~      Our team has already demonstrated that the growth kinetics of the MM was a prognostic factor~     of tumor aggressiveness regardless of the thickness of the tumor. Using the same method to~     calculate the growth rate, an Australian team recently studied the growth rate in a~     population of patients suffering from MM. In this population 1/3 of MM had a growth of more~     than 0.5 mm per month. Clinical aspects and FGMM of these risk factors were individuals~     (injuries symmetrical achromic and regular occurrence among about older and low-nevi). The~     European and Australian people are very different in particular regarding the prevention~     policy, these results can not be extrapolated to the French population.The main objective is~     to identify risk factors for FGMM in French propulation~   "
52562|NCT02878941|"~     The objective of this study is to obtain and compare bilateral elbow joint synovial fluid~     from patients with unilateral intraarticular elbow fracture and a contralateral healthy~     appearing elbow joint. The synovial fluid samples will undergo several forms of analysis for~     metabolites and proteins. Matched-pair statistical analysis will be performed to determine~     the metabolites and proteins that may play the greatest role in development of joint~     contracture.~   "
52522|NCT02879461|"~     Stenosis of symptomatic lumbar canal is presented as a series of degenerative changes~     affecting the various vertebral segment structures, including: a joint zigoapofisária, yellow~     ligament, the articular capsule and the intervertebral disk. These changes decrease the area~     of the spinal canal and press the neural structures and may present clinically as the narrow~     tunnel syndrome.~      This presentation was first described by Verbiest associated with these anatomical changes~     the clinical manifestations; corresponding to low back pain, pain in the legs that worsen~     with the fact ambulate and improve with rest, this presentation called neurogenic~     claudication .~      The lumbar canal stenosis was divided into two main types; congenital and acquired . The~     first is associated with a reduced size of the pedicles, which leads to a reduction of the~     diameter of the spinal canal, common in patients achondroplasics . The acquired is considered~     the most common type and is associated with aging, including all anatomical structures of the~     lumbar segment .~      With an aging population the number of symptomatic patients is increasing, although there is~     no statistic defined stenosis of symptomatic lumbar canal is the main reason for surgical~     approaches to the spine in patients over 60 years of age (7).~      As described by Daffner et al a reduction in blood flow leads to production of inflammatory~     mediators, which associated with anatomical changes previously described lead to the clinical~     picture with lameness and pain in the lower limbs Treatment of these patients is beginning~     with guidance on the disease, adequate pain control, physical therapy and exercise for~     maintaining the activities of daily living. If these measures fail a surgical approach may be~     necessary, especially in patients with exercise intolerance, difficulty walking and urinary~     incontinence .~      The surgical approach despite being widely studied in the literature prospective controlled~     studies are rare, found series of case studies or retrospective studies, we try to evaluate~     the effectiveness of surgery compared to rehabilitation in symptomatic patients in an attempt~     to assess the impact of surgery associated with comparing therapy with isolated therapy in~     these patients.~   "
52523|NCT02879448|"~     The Amulet™ device will be evaluated for safety and efficacy by demonstrating its performance~     is non-inferior to the commercially available WATCHMAN® left atrial appendage closure device~     in patients with non-valvular atrial fibrillation. Patients who are eligible for the trial~     will be randomized to receive either the Amulet device or the WATCHMAN device and will be~     followed for 5 years after device implant.~   "
52524|NCT02879435|"~     This research will explore the question of whether preincisional skin infiltration with~     bupivacaine 0.25% decreases postoperative pain after Cesarean delivery.~   "
52525|NCT02879422|"~     Type 2 Diabetes (TD2) is the leading cause of new cases of preventable blindness in these~     countries (and the gold-standard treatment, laser photocoagulation has proven to be effective~     in preventing vision loss at the end stage of eye disease due to proliferative diabetic~     retinopathy (PDR) that occurs in 3 to 6 % of the cases.Therefore, the ongoing search for~     predictive factors of sight threatening stages of diabetic retinopathy has become more~     important.~      Previous studies that have examined candidate predictive factors for diabetic eye disease~     have mostly focused on systemic risk factors leading to PDR. Among various clinical~     parameters, increased HbA1c % levels, uncontrolled blood pressure, diabetes duration,~     neuropathy and elevated triglycerides have been associated with PDR.~      Some genetic factors may also account for the development of PDR and are prospectively~     considered in this study .~   "
52526|NCT02879409|"~     There are numerous possible reasons why it could be speculated that HbA1c variability may~     affect complication risk. Of interest are the concepts that both laboratory and clinic~     evidence suggests that periods of sustained hyperglycemia are 'remembered' (metabolic~     memory), this in turn is recognized to place patients at greater long-term risk of~     complications. As such it can be speculated that the detrimental effect of variability in~     HbA1c may be mediated via the same mechanism as 'metabolic memory' phenomenon.~      Aims: To determine whether treatment to one of 2 threshold levels will result in one group of~     type 2 diabetes patients having the same mean HbA1c but with differing HbA1c variability to~     that of another and related to markers of oxidative stress, inflammation and microvascular~     complications. To determine whether a difference in HbA1c variability between the 2 groups~     will reflect in changes in small nerve fibers assessed with the sensitive method of corneal~     confocal microscopy and cardiac autonomic function testing. To assess the reproducibility of~     HbA1c measurement from a whole blood samples initially analyzed and then stored at -80C until~     the end of the study (2-3 years), as well as storing an aliquot of haemolysate, for~     reanalysis at the end of the study.~      In one arm the investigators will intensify treatment in those with FPG>140mg/dl until their~     FPG is <90mg/dl, using whatever treatment is clinically appropriate for them, and only~     intensify it further if their FPG rises to >140mg/dl again. In the other group the~     investigators will intensify if their FPG is >115 mg/dl until it is <=115 mg/dl and intensify~     further if >115 mg/dl again. A total of 20 visits within a time frame of 2 and half years~     will be performed. Visits procedures will include routine biochemistry, eGFR, lipids, fasting~     glucose, insulin and full blood count, HbA1c, SHBG, hsCRP. EPIC and G-PAQ questionnaires will~     be collected. Autonomic function testing using deep breathing heart rate variability, and a~     sensitive measure of small fiber neuropathy using corneal confocal microscopy and a 24 hour~     urine collection for urinary isoprostanes to measure oxidative stress will be performed, at~     baseline, 12 and 24 months.~   "
52527|NCT02879396|"~     Saint Luke Home (SLH) is a home for low-income seniors who are ≥ 55 years and in need of~     basic living help in Tucson, Arizona. Reports shows that emergency calls are made from SLH~     (64 residents) around 60 times each year with emergency department (ED) visits and hospital~     admissions that follow. In 2014, a total of 70 calls were made, and in 2015, 49 calls. The~     Director, who is a nurse by training, and staff report that many of these calls are related~     to medications and may be avoidable. Therefore, we believe we can make a difference and~     decrease emergency calls, ED visits and hospitalizations that can be avoided with a program~     to teach the elders and staff at SLH. The program is called Preventing Avoidable Admissions~     Among Assisted Living Elders (PA4LE) and will consist of a 2-hour session every two weeks~     including home or clinic visits (elder preference), educational sessions, and staff training.~   "
52528|NCT02879383|"~     The Revita System is intended to improve glycemic control in patients with Type 2 diabetes~     who have preserved pancreatic beta cell function and whose diabetes is poorly controlled with~     oral anti-diabetic medications. The purpose of this study is to demonstrate the efficacy and~     safety of the Fractyl DMR Procedure using the Revita System compared to a sham procedure for~     the treatment of uncontrolled type 2 diabetes.~      Subjects randomized to the DMR procedure are followed per protocol for 48 Weeks. The Sham~     treatment arm will cross over to receive the DMR treatment at 24 weeks with background~     medications held constant from 24-48 weeks of follow up.~   "
52529|NCT02879370|"~     The technique the investigators propose to perform colorectal and colo-anal anastomosis in~     patients underwent low and ultra-low anterior resection for rectal cancer could potentially~     reduce the anastomotic leakage rate by better trans-anal introduction of the circular~     stapler, elimination of the previous suture lines and dog ears, combined with direct~     inspection of the anastomosis, easy performance of trans-anal air leak tests and eventually~     direct repair of any small anastomotic defects. Another important point in cancer surgery is~     the easily identification of the distal margin. In fact, this technique is simple to perform,~     reproducible and safe in terms of complications.~   "
52530|NCT02879357|"~     The hypothesis of the Serious Illness Care Program (SICP) is that adherence to the Serious~     Illness Conversation Guide (SICG) portion, the SIGC, will enhance patient understanding and~     allow control over their own decisions, relieve burdens of decision-making on family members,~     and help patients achieve a state of peace as they approach the end of life.~   "
52531|NCT02879344|"~     ECMO (extra-corporeal membrane oxygenation) is a blood oxygenation technical and purification~     of carbon dioxide by means of an extracorporeal circulation using a pump (identical to those~     used in cardiac surgery) and a membrane permitting gas exchange. This technique is used for~     almost 40 years in the acute respiratory distress syndrome (ARDS) but benefited from many~     technology improvements over the past 10 years.~      The circuit is now fully pre-heparin, not imposing obtaining activated partial thromboplastin~     time (aPTT) high. Centrifugal pumps limit the risk of intravascular hemolysis. The~     multi-perforated drainage cannula in place in femoral vein or jugular no longer need to~     maintain hypervolaemia to ensure sufficient flow.~      The membrane ensuring gas exchange is now polymethylpentene. This hollow fiber system ensures~     the gas exchange.~      In light of recent technical improvements, manufacturers indicate that the membranes can be~     used for 3 weeks. However, after a few days of use, fibrinoplaquettaires microthrombi form at~     the ECMO circuit, up from cannulas up to the oxygenator, decreasing membrane efficiency and~     imposing more early changes of the circuit. This hypercoagulable state was revealed through~     the study of classical plasma markers of coagulation. There is not so far from reliable~     predictive marker of thrombus formation, indicating a need to change the circuit.~      The production of microparticles (MPs) is a characteristic of cells subjected to an~     activation or apoptosis. MPs are membrane Smaller fragments released into the extracellular~     milieu after rupture of the asymmetry of the distribution of membrane phospholipids and~     characterized by the presence of phosphatidylserine (PhtdSer) on their surface, as well as~     various antigens expressed by their cells of origin. The PhtdSer is a pro-coagulating surface~     on which are going to assemble the enzymes responsible for the formation of thrombin and~     increases proportionally the TF activity ultimately leading to fibrin polymerization in the~     vessels.~      The vesiculation phenomenon exists in healthy subjects. In human pathology, many examples~     emphasize the fundamental role of MP in clotting or thrombosis. The PM generating fault is~     associated with bleeding disorders (Scott syndrome, dysvésiculation syndrome). Conversely,~     high circulating levels of MP are found in many thrombotic diseases (myocardial infarction,~     diabetes, antiphospholipid antibody syndrome, preeclampsia ...). Platelet and intense~     monocyte endothelial activation, observed in sepsis and severe trauma, is accompanied by the~     generation of procoagulant MP carriers of tissue factor (TF). These MP diffuse into the~     vascular compartment pathogenic potential may exacerbate inflammatory and thrombotic~     responses and play a leading role in triggering the DIC.~      More recently, various studies have shown that the microparticles are not only activation~     markers or injury, but also cellular elements having a true pathogenic role. Because they~     contain or express on their surface various biological effector (adhesion molecules, tissue~     factor, inflammatory mediators or apoptogenic, growth factor ...) the microparticles are able~     to interact with their environment and modulate cellular very different way the properties of~     target cells. And platelet or leukocyte microparticles could actively participate in the~     thrombotic process by increasing adhesion of monocytes and endothelial cells, or by inducing~     endothelial procoagulant response.~   "
52532|NCT02879331|"~     The study hypothesis is that patients with homogeneous emphysema behave differently compared~     to heterogeneous emphysema with respect to exercise capacity. A better understanding of this~     difference will allow the investigators to choose the best treatment for each type of~     patient.~      The main purpose of this study is to evaluate the change in exercise capacity measured by~     cycle ergometry in patients with severe emphysema after endoscopic lung volume reduction with~     coils (eLVR).~      As a secondary purpose, the investigators want to perform an exploratory, randomized study to~     compare the results of two different therapeutic approaches in a small sample of patients~     with homogeneous emphysema.~   "
52533|NCT02879318|"~     The standard or usual treatment for this disease consists of two chemotherapy drugs~     gemcitabine and nab-paclitaxel given together.~   "
52534|NCT02879305|"~     The purpose of this multi-center event-driven study in participants with anemia associated~     with chronic kidney disease (CKD) to evaluate the safety and efficacy of daprodustat.~   "
52535|NCT02879292|"~     Infantile hypertrophic pyloric stenosis (HPS) is one of the most common gastrointestinal~     medical emergencies.This retrospective study will review the files of all infants with HPS,~     who were treated by open pyloromyotomy under spinal anesthesia in the Bnai Zion Medical~     Center between the years 2006 to 2015.~   "
52536|NCT02879279|"~     Stroke is frequently associated with significant disability and impaired quality of life.~     Persistent motor impairment is common with often incomplete recovery of motor function in~     response to rehabilitation, mainly in the upper limbs. Robot-mediated therapy has been~     proposed as a viable approach for the rehabilitation of the upper limb, but as the evidence~     quality is low, more rigorous studies are needed. Previous studies have focused on the~     effects of devices acting on a limited number of joints, often limiting the workspace on a~     plane. This study aims to evaluate the efficacy of a multi-set of robotic and technological~     devices for the rehabilitation of the upper limb in sub-acute stroke patients.~   "
52537|NCT02879266|"~     This study will evaluate the safety and immunogenicity of a tetravalent dengue vaccine~     TetraVax-DV TV005 in adults 50 to 70 years of age with no history of previous flavivirus~     infection.~   "
52538|NCT02879253|"~     This study is part of the french research program ANR NEMRO MICROROBOTIC NASAL ENDOSCOPY BY~     OPTICAL COHERENCE TOMOGRAPHY: IMPACT OF SMELL DEFICIENCY ON NEURODEGENERATIVE DISEASES.~     Recent studies have shown a strong correlation between the decrease in olfactory faculties of~     patients and the presence of neurodegenerative diseases.~      This possible relationship has created a need to inspect in detail the area of the nasal~     cavity that houses the olfactory function.~      Thus, the purpose of NEMRO project is developing a robot to explore olfactory slots of~     patients, with a view to extract images through non invasive imaging probe, and hoping to~     identify early signs of degeneration the olfactory tissue. The robot developed will thus be~     able to navigate in the nasal cavity of patients, and to break into the olfactory slots,~     which will host the imaging phase.~      The purpose of this study is therefore to collect data on the usual path of instruments~     (endoscope, for example) in this area, and future potential pathway of the robot. This~     collection made from Computed Tomography (CT) scans will define the clinical geometry of the~     target area and provide precisely the dimensional constraints needed to build the NEMRO robot~     .~   "
52539|NCT02879240|"~     Up to 50% of infants and young children cry during the administration of their inhaled~     treatment for their asthma. This results in decreased lung deposition, and thus decreased~     effectiveness of their inhaled treatment.~      The objective of this study is to evaluate whether animated cartoons can increase the~     cooperation of young children with asthma who are not cooperative during the delivery of~     their ICS therapy through a pMDI/spacer.~   "
52540|NCT02879227|"~     Phase II study of radiochemotherapy for elderly patients with oesophagus cancer.~   "
52541|NCT02879214|"~     The purpose of this study is to determine the feasibility of minimal invasive surgical~     resection through simultaneously integrated dose escalation given concurrently with~     chemotherapy for locally advanced squamous cell cervical cancer.~   "
52542|NCT02879201|"~     The investigators conducted a comparison trial between SLED and CRRT in critically ill~     patients to evaluate the outcome for all cause mortality at 30 day . The secondary outcome~     were recovery of renal function, complications during therapy and duration of~     hospitalization.~   "
52543|NCT02879188|"~     The purpose of this study is to determine the impact of the timing of physical therapy (PT)~     initiation on postoperative length of stay and the time to physical therapy clearance~     following total knee replacement.~   "
52544|NCT02879175|"~     After endovascular treatment of the intracranial aneurysm, recanalization may occur, with a~     risk of recurrent subarachnoid haemorrhage or long-term angiographic recurrences of~     aneurysms.~      Few data exist on patients' long-term follow-up after subarachnoid haemorrhage caused by~     ruptured intracranial aneurysms.~   "
52545|NCT02879162|"~     The standard or usual treatment for this disease may be chemotherapy or other types of~     treatment to slow the spread of the disease and relieve some symptoms of this cancer.~   "
52546|NCT02879149|"~     The objective of this long-term study is to evaluate the long term effectiveness and safety~     of AUGMENT® Bone Graft vs. autologous bone graft. The study involves evaluation of subjects~     originally treated under Protocol BMTI-2006-01.~      Subjects will be asked to consent and return to provide long-term follow-up data at or after~     60 months (5 years) have elapsed since their original surgery as a subject in protocol~     BMTI-2006-01.~      STUDY HYPOTHESIS: The effectiveness and safety profile for AUGMENT® Bone Graft is maintained~     and remains comparable to that of autologous bone graft over long-term subject follow-up.~      REGULATORY PHASE: Post-approval study~   "
52547|NCT02879136|"~     Gait and balance problems are a significant source of disability in patients with Parkinson~     disease. Physical therapy remains one of the main treatments. On the other hand some~     medications, such as methyphenidate and atomoxetine, have been tried with promising results.~     The outcomes in gait and balance in Parkinson disease after a combination of physical therapy~     and the medications mentioned above have not been explored yet. The investigators want to~     evaluate whether the addition of medication, either low dose of methylphenidate or~     atomoxetine, to physical therapy will achieve improvement in gait and balance in Parkinson~     disease more than physical therapy alone. The investigators propose a pilot, single center,~     rater blind, prospective randomized trial. 2-arm-parallel group, intention-to-treat analysis.~   "
52549|NCT02879110|"~     In this proposed study, the investigators will evaluate the the efficacy, safety and related~     mechanism of sulforaphane in treatment of autism spectrum disorder (ASD). The study will~     recruit 120 ASD patients, then these patients will be randomized to sulforaphane group or~     placebo group (60 patients per arm) for 12 weeks clinic trial. Clinical efficacy and safety~     assessment will be done at screen/baseline, 4 week, 8 week and 12 week. The specific aims are~     to compare sulforaphane versus placebo on: 1) clinical core symptoms; 2) other behavioral~     problems and adaptive behaviors. Biological samples also will be collected, and stored to~     research related mechanisms.~   "
52550|NCT02879097|"~     The purpose of this study is to determine whether CBT124 and Avastin® are comparable in terms~     of efficacy, safety, immunogenicity; and whether the pharmacokinetics of CBT124 matches that~     of Avastin® (pharmacokinetics is nested in this study for Indian patients).~   "
52551|NCT02879084|"~     This study investigates the variations in the retinal nerve fiber layer (RNFL) thickness~     during uncomplicated anterior and intermediate uveitis, respectively. The objectives are to 1~     ) confirm the RNFL thickening during an uncomplicated anterior uveitis as described in the~     literature, 2) measure the RNFL thickness during an uncomplicated intermediate uveitis~     specifically and 3) describe the variation in time of RNFL thickness during the two types of~     uveitis.~   "
52552|NCT02879071|"~     The time-frame and the follow-up elements after embolization of brain arteriovenous~     malformations are not standardized. Therefore, few reliable follow-up data are available for~     these patients. This study aims at collecting standardized long term data for these patients.~   "
52553|NCT02879058|"~     This study evaluates whether use of intraoperative ultrasound during laparoscopic or robotic~     myomectomy impacts quality of life. Half of participants will undergo laparoscopic or robotic~     myomectomy with use of the intraoperative ultrasound and half will undergo traditional~     laparoscopic or robotic myomectomy.~   "
52554|NCT02879045|"~     The effect of elasticity Belly® oil and Clarins® Tonic Body Treatment Oil in prevention of~     striae gravidarum: A randomized controlled clinical trial.~   "
52555|NCT02879032|"~     Exercise treadmill test (ETT) is frequently done, inexpensive, relatively safe investigation~     for diagnosis of ischemic heart disease and prediction of exercise capacity. Ischemic heart~     disease is increasing by leaps and bounds all over the world even in the developing countries~     like Bangladesh. The incidence rate of coronary artery disease (CAD) is not limited to male~     gender as previously seen. As a cause of industrialization and increased life expectancy,~     incidence of ischemic heart disease in females is escalating now in Bangladesh also. Though~     ETT is a well accepted investigation to diagnose CAD, it has a high false positive and false~     negative result if ST segment response alone is calculated for interpretation of the test.~     Duke Treadmill Test and Simple Treadmill Test are valid and well known scores which can~     predict coronary artery disease burden more efficiently than ST segment response alone.~     Computer generated Cleveland clinic score is another valid treadmill score which has a~     complex algorithm but effective way to predict 3 year and 5 year survivability. These three~     scores are well tested on western population but to our best knowledge there is little or no~     information regarding their predictability of CAD in Bangladesh. It's well known that ETT has~     a high false positive result in female population, so applying the scores may render ETT more~     efficient and abrogate unwanted risk of undergoing coronary angiography to diagnose CAD in~     females. In this study the investigator will try to find out the accuracy of commonly applied~     treadmill scores and ST segment response to diagnose CAD as well as accuracy of computer~     generated Cleveland Clinic Score will be tested. Total 110 people including male and female~     will be included according to inclusion and exclusion criteria and informed written consent~     will be taken. The patients who have undergone ETT and coronary angiogram with in six months~     for confirmation and identification of coronary artery disease in accordance with the~     recommendation of ACC guideline for CAG will be selected . All available data will be~     analyzed using SPSS. The accuracy of different scores will be calculated and compared with~     each other. According to currently available data from studies in western population the~     treadmill scores will have good predictability and will be efficient to abolish high false~     positive result in female population in Bangladesh.~   "
52556|NCT02879019|"~     Whereas the efficacy of exercise interventions has been abundantly proven in male with~     peripheral artery disease (PAD), it remains to be determined whether these interventions are~     effective in women. The aim of this randomized controlled trial which will be performed with~     34 PAD women will be to investigating the effects of 12 weeks of supervised walking on~     functional capacity and cardiovascular function and regulation at rest and during exercise.~   "
52557|NCT02879006|"~     The purpose of this study is testing the use E-B-FAHF-2 Chinese herbal therapy in combination~     with multi-food oral immunotherapy (OIT) and Xolair® (Omalizumab) to help children and adults~     who are allergic to foods be able to safely tolerate food allergens. Specifically in this~     protocol, the food allergens are milk, egg, peanut, almond, cashew, hazelnut, walnut, sesame,~     and/or wheat. Omalizumab is considered an investigational drug for the treatment of food~     allergies in children and adults. Investigational means it has not been approved by the Food~     and Drug Administration (FDA) for use in the U.S. The researchers hope to learn whether the~     addition of Chinese herbal therapy (E-B-FAHF-2) can improve the outcome of sustained~     unresponsiveness (which is the ability to consume a food allergen and pass an oral food~     challenge after being off treatment for 3 months) as compared to placebo (i.e. subjects with~     OIT/Omalizumab + herbal vs. OIT/Omalizumab + placebo), and will help adults and children be~     able to safely ingest the foods they are allergic to.~   "
52558|NCT02878993|"~     This study aims to assess whether the electrical signal of the diaphragm (diaphragm~     electromyogram) and the ratio of that to tidal volume (amount of air breathed in and out of~     the lungs) can predict which infants will be successfully extubated (have the breathing tube~     removed without needing it replaced.)~   "
52559|NCT02878980|"~     This clinical trial studies how well an exercise intervention works in reducing symptoms and~     improving clinical outcomes in patients with ovarian cancer undergoing platinum-based~     chemotherapy. Exercise may train the body to repair deoxyribonucleic acid (DNA) damage more~     efficiently, which may reduce symptoms related to platinum-based chemotherapy, improve~     quality of life, increase survival, and decrease recurrence rates in patients with ovarian~     cancer.~   "
52560|NCT02878967|"~     The time-frame and the follow-up elements after embolization of brain aneurysm are not~     standardized. Therefore, few reliable follow-up data are available for these patients.~      This study aims at collecting standardized long term data for these patients, in order to~     assess the occurence of aneurysm recanalization and particularly those requiring another~     intervention on the aneurysm.~   "
52561|NCT02878954|"~     This research project aims to investigate the gender-based difference in patients with~     peripheral artery disease. To attend this, this study has two specific objectives:~      Objective 1: To identify gender-specific barriers towards exercise and physical activity in~     patients with peripheral artery disease (PAD).~      Objective 2: To evaluate gender-specific differences in functional capacity and~     cardiovascular function and regulation in patients with PAD at rest, during and following a~     single session of maximal exercise.~   "
52565|NCT02878902|"~     Kidney failure is a major public health problem. REIN registry shows that 33% of patients~     treated in renal replacement therapy for ESRD start dialysis in emergency. Unscheduled care~     is associated with an increased risk of morbidity and mortality, with less access to off~     dialysis center and kidney transplant. In addition, the emergency management has an impact on~     the organization of health structures. The High Authority of Health in 2012 issued a care~     pathway Guide aimed to report in this process of the multidisciplinary nature of the~     management and coordination of principles and procedures for the Chronic Renal failure and~     cooperation between professionals involved.  A function of coordinator of the Chronic Renal~     Disease was set up in service since May 2013. Investigators propose to carry out a study to~     value its impact on the start of the dialysis in emergency and hypothesize that this feature~     innovative in France improves the patient pathway and thus reduce support emergency frequency~     of ESRD.~      The objective of this study is to show the improvement of the quality of care for terminally~     chronic renal failure patients.~      This is to evaluate an experiment aimed to facilitate a complex care path. If this experiment~     is successful, it could form part of advanced practice.~   "
52566|NCT02878889|"~     A Phase II Trial of S-1 as Maintenance Treatment After Gemcitabine Plus Cisplatin Regimen~     Chemotherapy in Patients With Recurrent and/or Metastatic Nasopharyngeal Carcinoma.~   "
52567|NCT02878876|"~     This is a 3-sites, double-blinded, randomized, 2X2 cross-over study aiming to compare effects~     of milk containing only A2 type beta casein versus milk containing both A1 and A2 beta casein~     proteins on the gastrointestinal symptoms for the health people who self-reported to be~     lactose intolerant.~   "
52568|NCT02878863|"~     An open-label,prospective, randomized pilot study to evaluate the efficacy, safety and~     tolerability of paeoniflorin, for the treatment of autoimmune hepatitis (AIH) with mild~     necroinflammatory activity on liver biopsy.~   "
52569|NCT02878850|"~     The purpose of this study is to learn more about how participants heal from acute spinal cord~     injury.~   "
52570|NCT02878837|"~     This randomized, open clinical trial sought to compare the use of Midazolam and~     Dexmedetomidine during surgery in patients under regional anesthesia.~      The primary objective was to determine the superiority of either drug during the~     intraoperative period regarding: 1- Depth of sedation and 2- incidence of complications.~      Secondary objectives included the determination of superiority regarding the postoperative~     period.~      For that, patients were randomized into two groups and sedated with either Midazolam or~     Dexmedetomidine.~   "
52571|NCT02878824|"~     Difference in autonomic nervous system processes across cultural and ethnic groups was~     suggested and autonomic regulation differentiation may occur even at an early age. However,~     the role of ethnicity and environment on regulation of response towards sensory stimulation~     in children is not well understood yet. This research aims to compare the autonomic activity~     at resting condition and toward a block of auditory stimulation between typically developing~     children from different countries and living environments. There will be two phases in this~     study. In Phase I, two groups of participants will be recruited: (a) 32 typically-developing~     Chinese children living in Hong Kong, (HK group) and (b) 32 typically developing Filipino~     children living in Hong Kong (Fil-HK group). In phase II, two groups of participants will be~     recruited: (a) 32 typically-developing Filipino children who are living at Urban area (PH-U~     group), and (b) 32 typically developing Filipino children who are living at Philippines-Rural~     area (PH-R group). Participants will be composed of males and females ages 7-12 years old,~     and without known history of developmental disabilities, medical history of cardiac or~     pulmonary problem, medical history of diabetes, or having any sensory deficits. Recruited~     participants will watch a silent movie, and listen to a block of sound. Autonomic activity~     (heart rate variability and electrodermal activity) will be measured and recorded using Polar~     H2 heart rate monitor and eSense skin response. Recordings will be screened for ectopic beats~     of HRV or bursts of EDA. The HRV and EDA signals will be processed by using aHRV and the~     eSense propriety software, respectively, and according to the standards of editing HRV and~     EDA artefacts. Autonomic activity (LF, HF and EDA) at resting condition, and hypothesis~     interaction between conditions (resting condition vs. auditory stimulation) and groups (HK~     group and PH-U group; Fil-HK group and PH-U group; PH-U group vs. PH-R group) will be tested~     with repeated measures of MANOVA. All significant levels will be set at p≤ 0.05. This study~     will increase the understanding on the role of culture and environment in the regulation of~     behaviour in auditory processing. The findings of this research may further shed light on the~     evaluation and treatment planning for children across and within cultures.~   "
52572|NCT02878811|"~     The investigators will consecutively recruit 5000 patients hospitalized for heart failure~     (HF) from 50 hospitals across China and follow them up for one year, describe treatment~     patterns during hospitalization and the follow-ups, examine patients recovery trajectory~     after HF, and identify targets for care quality improvement.~   "
52573|NCT02878798|"~     The TopCSPN trial is a double blinded randomized placebo controlled study of oral topiramate~     as a potential disease altering therapy for cryptogenic sensory peripheral neuropathy (CSPN).~     Patients with CSPN who also have metabolic syndrome (defined by the ATPIII criteria) who do~     not have an alternative cause for neuropathy will be potentially eligible. The co primary~     outcome measures are change in the Norfolk Quality of Life - Diabetic Neuropathy (NQOL-DN)~     Scale and intraepidermal nerve fiber density (IEFND) at the distal thigh. The treatment phase~     will last 24 months.~   "
52574|NCT02878785|"~     The purpose of this study is to find the best way to combine a new chemotherapy drug with one~     that is already in use to treat AML. The new experimental drug is called talazoparib (also~     known as BMN-673), and it is not approved by the Federal Drug Administration (FDA). The FDA~     is allowing the use of talazoparib for the purposes of this study.~      Decitabine is used to treat bone marrow diseases called myelodysplastic syndromes (MDS), as~     well as off label for AML.~      Lab work suggests that talazoparib will increase the effects of decitabine in leukemia cells.~      Investigators hope that treating patients with decitabine and talazoparib together will be~     more successful that treating patients with decitabine alone.~      This study has two parts. The purpose of part one the study is to find out the best doses of~     decitabine and talazoparib to use when they are given together to treat AML. The purpose of~     part two is to see how well the drugs work together to treat AML.~      All participants in the study will be treated with decitabine and talazoparib.~      Part one of the study will include as few as two people and as many as 36 people to find the~     best dose levels of the study drugs. Part one will begin enrolling first. Part two of the~     study will not start until the Part one of the study is complete. Participants will be told~     which part of the study they may be enrolled in. Part two of the study may include as few as~     79 people and as many as 135 people. Part two includes three separate arms. Participants~     enrolled in Part two of the study, will be assigned to one of the three arms below in order~     to test the success rate of the study drug dose determined by Part one:~        -  Arm A will enroll adult patients with AML who are thought not to be likely to tolerate~          or respond to standard chemotherapy;~        -  Arm B will enroll adult patients with AML that has not responded to previous treatment~          or has come back after responding to previous treatment;~        -  Arm C will enroll adult patients previously treated with a DNA methyltransferase~          inhibitor (decitabine, azacitidine or guadecitabine).~      This is a multi-center study. Up to 171 people may take part in this study globally.~   "
52575|NCT02878772|"~     Immunity and inflammation play critical roles in the pathogenesis of acute ischemic stroke.~     Therefore, immune intervention, as a new therapeutic strategy, is worthy of exploration.~     Here, investigators tested the inflammation modulator, vinpocetine, for its effect on the~     outcomes of stroke. For this multi-center study, investigators recruited 60 patients with~     anterior cerebral circulation occlusion and onset of stroke that had exceeded 4.5 hours but~     lasted less than 48 hours. These patients, after randomly division into two groups, received~     either standard management alone (controls) or standard management plus vinpocetine (30 mg~     per day intravenously for 14 consecutive days, Gedeon Richter Plc., Hungary).~   "
61860|NCT02757196|"~     a prospective, multicenter, randomized, open-label, Phase II, two arms interventional trial~     performed in 5 departments of hematology in China~   "
52577|NCT02878746|"~     The investigators developed a real-time 2-axis mirror robot system as a simple add-on module~     for conventional mirror therapy using a closed feedback mechanism, which allows for real-time~     movement of the hemiplegic arm. The investigators conduct a case study for stroke patients~     with a two-dimensional mirror robot for 30 min per day for two weeks (10 sessions). For the~     conventional mirror therapy group, the investigators prepared the tasks for fine motor~     training.~   "
52578|NCT02878733|"~     The invesitgators utilized the Cerner HealthFacts database (a large HIPAA-compliant~     clinical-administrative database maintained by Cerner Inc., USA) to identify a cohort of~     6,249 adults that underwent on-pump cardiac surgery for valve and/or coronary artery~     procedures between January 2001 and March 2013. Of these, the investigators selected 1136~     patients who received 5% albumin on the day of or the day following cardiac surgery and~     matched them (1:1) with 1136 patients who did not receive albumin. Characteristics on which~     patients were matched included patient demographic, hospital and procedural characteristics,~     baseline patient comorbidities including preoperative CKD and 26 other grouped conditions, as~     well as acute severity of illness at admission to ICU.~   "
52579|NCT02878720|"~     Previous studies suggested that both robot-assisted rehabilitation and non-invasive vagus~     nerve stimulation can improve upper limb function in chronic stroke patients. Aim of present~     study is to explore whether the combination of these two approaches might enhance their~     positive effects on motor recovery. Safety and efficacy of this combination will be assessed~     within a proof-of-principle, double-blinded, randomized, sham-controlled trial.~     Transcutaneous vagus nerve stimulation (tVNS) will be delivered at left ear, in order to~     improve the response to the following robot-assisted therapy. Patients with both ischemic and~     hemorrhagic chronic stroke will be randomized to robot-assisted therapy associated with real~     or sham tVNS, delivered for 10 working days. Change in Fugl-Meyer has been chosen as primary~     outcome, while changes in several quantitative indicators of motor performance extracted by~     the robot as secondary outcomes.~   "
52580|NCT02878707|"~     Dexmedetomidine (DEX) is a Alpha-2 specific agonist, is a common ICU sedation medication. In~     brain tumor resection craniotomy, it is proven to be effective in improving postoperative~     hypertension and tachycardia, mitigates postoperative nausea and vomiting and relives~     postoperative pain. In addition, many animal experiments show that DEX inhibits the~     proapoptosis in the mitochondrial in vivo and therefore avoids neuronal injury. It is also~     reported to be neuroprotective to isoflurane-induced neurotoxicity and to improve cerebral~     focal ischemic region (penumbra). However, the neuroprotective effects were never~     investigated clinically in patients undergoing brain tumor resection surgery.~   "
52581|NCT02878694|"~     Interventional , multicenter , comparative study. One eye receiving the cells and the~     contralateral eye as a negative control . If effectiveness following review of the primary~     endpoint and the advice of an independent expert committee , the experimental treatment will~     be offered to the patient to the contralateral eyelid.~      Objective is to restore muscle function levator muscle of the upper eyelid by providing a~     registry of autologous myoblasts from a non- clinically affected muscle .~   "
52582|NCT02878681|"~     The purpose of the study is to compare the effect of intravitreal injections of ranibizumab~     and aflibercept on systemic VEGF levels in DME patients in a detailed time course.~   "
52583|NCT02878668|"~     Post operative complication after hepatopancreatobiliary surgery is high as 30-50%，which is~     the main reason for patient admitted to ICU. Several biomarkers have been shown to be useful~     in the early diagnosis of sepsis and systemic bacterial infection. The purpose of this study~     is to assess the predictive value of biomarkers for early complication after~     hepatopancreatobiliary surgery and assess the effectiveness of anti-infectious therapy.~   "
52584|NCT02878655|"~     The nodal involvement in squamous cell carcinomas of the upper aerodigestive tract (VADS) is~     one of the main factors of poor prognosis, justifying the surgical management of neck~     dissection as a reference treatment.~      Under the influence of the American Hayes Martin, it was considered until the 1960s that~     over the intervention was, the greater the chance of recovery was. But has since been~     developed by the Argentine Osvaldo Suarez the concept of functional course, which consists of~     resection of lymph node tissue while retaining the main structures (muscles, nerves,~     vessels), as opposed to the recess radical which is reserved for the invasive metastasis.~      In addition to these notions, our job is to evaluate the quality of life of patients with~     SCCHN, N0 clinical and radiological, enjoying a functional neck dissection including IIb~     sector to support the approach which would be to stop the systematic inclusion of this~     territory.~   "
52585|NCT02878642|"~     The main assumption is that the dolutegravir can get virologic suppression to suboptimal~     adherence levels (between 80 and 95%, and after treatment interruptions) where other~     molecules are not capable, due to their pharmacokinetic/pharmacodynamic (pardonnance).~      While the investigators goal is not to compare molecules (study with one arm) in terms of~     forgiveness, the results of this cohort in terms of forgiveness could be compared to other~     cohorts available.~   "
52586|NCT02878629|"~     The main objective is to evaluate middle term compliance (≥ 2 years) of the Mandibular~     Advancement Devices Tali® in patients with Syndrome of Obstructive Sleep Apnea and Hypopneas.~   "
52587|NCT02878616|"~     Investigate whether concomitant treatment with intravenous immunoglobulin (IVIG) can alter~     the pharmacokinetics and pharmacodynamics of LFG316 to an extent which would necessitate dose~     adaptation for LFG316 in pre-sensitized end-stage renal disease patients awaiting kidney~     transplantation~   "
52588|NCT02878603|"~     The objective of this study is to evaluate long-term safety and efficacy of caplacizumab, to~     evaluate safety and efficacy of repeated use of caplacizumab and to characterize long term~     impact of TTP.~   "
52589|NCT02878590|"~     Prospective, non-randomized, open label study~   "
52590|NCT02878577|"~     This project, will combine the data collected from existing and innovative technologies: fMRI~     scans, mapping brain connectivity using EEG in combination with eye-tracking technology (the~     BNA technology developed by ELMINDA), characterizing of cortical layers using magnetic~     resonance (the CoLI technology developed by Tel-Aviv University), and DTI imaging (imaging of~     brain tracks). To do so, Sheba's Medical Center, Tel Hashomer, joined the project and is~     responsible for recruiting patients from the Department of Neurosurgery and Department of~     Rehabilitation and also is responsible for performing the needed tests.~   "
52592|NCT02878551|"~     The process of enhancing functional capacity of the individual in anticipation of an upcoming~     stressor has been termed prehabilitation. In the present pilot trial, the impact of a~     multimodal prehabilitation intervention composed of exercise, nutritional supplement and~     psychological well-being begun in the preoperative period will be evaluated.~   "
52593|NCT02878538|"~     The investigators propose to conduct a series of N of One (No1) single blinded clinical~     trials to pilot the feasibility of using the iron-chelator deferiprone on Mild Cognitive~     Impairment (MCI). Chelation therapy has previously been reported to slow the rate of~     cognitive decline in Alzheimer's Disease (AD) by 50% in a single human randomized clinical~     trial.~   "
52594|NCT02878525|"~     The purpose of this study is to study the effectiveness of laparoscopic internal gastric~     banding as a treatment for morbid obesity in comparison to laparoscopic sleeve gastrectomy~   "
52595|NCT02878512|"~     Management of nephrolithiasis has been revolutionized by the advent of shock-wave lithotripsy~     (ESWL) and percutaneous nephrolithotomy (PCNL). PCNL is a minimally invasive endoscopic~     technique and is used for the fragmentation and removal of stones of size more than 20 to 30~     mm, staghorn stones or multiple stones resistant to ESWL. Anaesthesia for PCNL is a challenge~     because of the disease, surgical procedure, positioning, hypothermia,and the possibility of~     fluid absorption, dilutional anaemia and blood loss. General anaesthesia is the gold standard~     for this surgery.The advent of new drugs has refined the technique of general anaesthesia.~     However there are several issues related to prone position still to be addressed like~     accidental extubation and difficult reintubation, nerve injuries and post operative~     respiratory complications.~      Combined spinal epidural(CSE) and only epidural anaesthesia (EA) is a well established~     technique of anaesthesia for upper abdomen and lower thoracic surgeries. It use has also been~     reported in PCNL surgeries.Segmental epidural can selectively blocks pain fibres from the~     surgical site. This not only allows to limit the dose of the local anaesthetics, but also~     limit motor and sympathetic blockade. Selective sympathetic block is associated with~     respiratory, cardiac, gastrointestinal and metabolic benefits. This formed the basis of our~     current study. In the present study the investigators aimed to evaluate the efficacy of~     segmental epidural for PCNL and compared it with standard technique i.e. GA.~   "
52596|NCT02878499|"~     The primary objective of this study is to undertake a longitudinal investigation of the~     impact of sleep and circadian rhythm disturbances on cognitive and behavioural trajectories~     in children with autism spectrum disorder (ASD) age 3-10 years old.~      This innovative study will use objective quantifiable measures of sleep and circadian rhythms~     in addition to subjective measures.~      The investigators aim to assess the hypotheses that, in pre-pubertal children with ASD,~        1. sleep disturbances are correlated with circadian rhythm disturbances;~        2. both sleep and circadian rhythm disturbances are negatively correlated with cognitive~          performance and positively correlated with behavioural disturbances;~        3. sleep and circadian rhythm disturbances, most notably abnormal melatonin secretion,~          impact the cognitive and behavioural development of children with ASD, depending on age~          (prospective longitudinal analyses).~   "
52597|NCT02878486|"~     The purpose of this study is to determine whether the researchers can help people change the~     amount of time they spend in sitting activities and whether this change might improve health~     outcomes.~   "
52598|NCT02878473|"~     Diagnosis of intrahepatic cholangiocarcinoma (iCCA) is increasingly common in patients with~     liver cirrhosis, but these patients are denied liver transplantation (LT) by most centres due~     to historically poor results. Two retrospective evaluations have shown a 5 year survival ~65%~     in selected patients with an iCCA diagnosis at the pathology of the explanted liver. This~     suggests that LT can be a curative treatment if applied selectively. This study will evaluate~     the effectiveness of LT as a treatment for very early iCCA diagnosed in cirrhotic patients~     who meet the strict selection criteria. Patients with advanced cirrhosis (not candidates for~     resection) currently have no other curative treatment options. Participants will be allowed~     bridging therapies prior to receiving transplant. Participants will be followed for 5 years~     from the time of transplant with patient survival and disease recurrence as outcome measures.~   "
52599|NCT02878460|"~     The ORI (Reserve Oxygen Index) is an index measured through sensors SpO2 (oxygen saturation~     by pulse oximetry - Radical-7 MASIMO) that evaluates noninvasively PaO2 (partial pressure of~     oxygen). It represents the high PaO2 with values to 0 for a PaO2 <100 and up to 1 when the~     PaO2 rises above 200 mmHg. Monitoring by the ORI, with setting an alarm for low values~     (≥0,01) could help alert nurses when to decrease the FiO2 (inspired oxygen fraction). This~     could reduce the FiO2 and avoid hyperoxia (i.e. daily PaO 2> 80 mmHg or 100). In the~     literature, hyperoxia can be associated with prolonged mechanical ventilation, with increased~     risk of atelectasis, or with excess mortality. And the use of high FiO2 led to a~     over-consumption of oxygen and therefore to additional costs.~      The purpose of this feasibility study is to evaluate the use of ORI can help to decrease~     length of moderate hypoxemia (PaO2>100mmHg) during mechanical ventilation and oxygenotherapy,~     in comparison with monitoring the SpO2 only.~   "
52600|NCT02878447|"~     The sequelae of tuberculosis are still the commonest causes of haemoptysis in the developing~     world, where life-threatening haemoptysis remains a common and not infrequently fatal medical~     emergency. Haemoptysis can be life-threatening either as a result of compromised gas exchange~     or because of circulatory collapse secondary to acute blood loss. Haemodynamic and~     ventilatory support, followed by bronchial artery embolisation (BAE) as a bridge to~     potentially curative treatment such as lung resection, remains the standard of care. Often~     patients do not qualify for surgical intervention and BAE is, at best, a temporary solution.~     External beam radiotherapy (EBRT) may be an alternative, curative intervention in the~     management of haemoptysis in patients with no alternative options. There is a paucity of~     studies reporting the use of EBRT in patients without malignancy and with regards to specific~     doses of EBRT. This pilot study aims to explore the potential of varying doses of EBRT in the~     management of massive haemoptysis.~   "
52601|NCT02878434|"~     The researchers aim to record the incidence, treatment and long term follow up of fertility~     preserving cancer treatment. Both the oncological and fertility outcome are recorded.~      Study population: All patients with a cancer for whom a fertility preserving cancer treatment~     is applied. The results of the study population are compared to young women undergoing~     standard cancer treatment.~   "
52602|NCT02878421|"~     The purpose of this study is to assess the effects of electronic cigarettes-nicotine and~     electronic cigarette-nicotine free on endothelial function as compared to traditional~     cigarettes.~      Participants will be randomized to one of three groups in a 1:1:1 fashion. The groups will~     be:~        1. Continue with tobacco cigarettes~        2. Switch to electronic cigarettes containing nicotine plus flavor~        3. Switch to electronic cigarettes containing flavor alone Treatment period will be 28 days~   "
52603|NCT02878408|"~     Immunology combined to neurobiology now offer prominent tools to yield biomarkers, so far~     missing in psychiatry, and to design innovative treatment approaches based on the discovery~     of new molecular and cellular targets. As Bipolar Disorder and Schizophrenia are now known to~     be significantly associated with neuro-inflammation, the project I-GIVE will combine~     multidisciplinary approaches (clinical, viral, immunological, genetic) to explore a global~     hypothesis placing the Human Endogenous Retro-Virus, HERV-W, at the crossroads between~     susceptibility to environmental factors (such as winter-spring births, infections,~     urbanicity…) and genetic factors controlling immune responses.~      Thus I-GIVE will allow identification of new biomarkers and their correlation with clinical~     profiles and immuno-inflammatory/immuno-genetic markers, and description of~     patho-physiological mechanisms of a psychiatric disorder. In addition, I-GIVE should help to~     design innovative treatments and foster personalized psychiatry tailored to the needs of each~     patient. Notably, monoclonal antibodies anti-HERV-W Env will be assessed in a preclinical~     model for their ability to slow, stop, or even reverse the progression of the psychosis in~     patients. I-GIVE project should thus lead to major results that will have strong impacts on~     the scientific community, pharmaceutical industries and, in a longer term, on improvement of~     patients suffering Bipolar Disorder or Schizophrenia and their family.~   "
52604|NCT02878395|"~     The purpose is to search for enterocyte-specific or non-specific molecular signature of~     post-operating recurrence of Crohn's disease in transcriptome (measurement of gene expression~     through number of mRNA copies transcribed for each gene) and in methylome.~      Secondary objectives are to compare expression and methylation profiles according to:~        -  treatment response~        -  morphological (endoscopic and/or radiological) and clinical post-operating recurrence.~   "
52605|NCT02878382|"~     In topical photodynamic therapy (PDT) for non-melanoma skin cancers, a photosensitizing~     prodrug, 5-aminolaevulinic acid (ALA) or its methylated ester, methyl aminolevulinate (MAL),~     is converted to the endogenous photosensitizer protoporphyrinIX (PpIX).~      Reduced response rates are observed in thicker skin lesions, which may be due to insufficient~     PpIX accumulation within the target tissue.~      To enhance PpIX production,several physical and chemical pretreatments have been suggested.~     One of the chemical substances proposed to stimulate PpIX production is vitamin D because of~     its ability of being a keratinocyte pro-differentiating hormone.~      Based on in vitro and in animal model studies, we propose to study the potential impact of~     patient vitamin D pre-treatment in AK response to MAL-PDT.~   "
52606|NCT02878369|"~     In order to identify the responding patients with vascular filling test, this research aims~     to compare the performance of the increased flow in the femoral artery to the performance of~     the blood pressure increase.~      The reference measurement will increase cardiac output measured by ultrasound.~   "
52607|NCT02878356|"~     In the Swedish county councils and municipalities, Motivational Interviewing (MI) training~     with different forms and content is taking place as part of the implementation of the method.~     The study aims to evaluate to what extent the practitioners acquire and retain MI skills~     trough the different training methods used by comparing them with a format that in previous~     studies has shown to be required for the long-term acquisition of proficiency in MI; training~     including supervision consisting of feedback based on monitoring of practice.~   "
52608|NCT02878343|"~     This study will evaluate the comparative effectiveness of behavioral economic financial~     incentives and environmental strategies, separately and together, in achieving initial weight~     loss and maintenance of weight loss, in obese employee populations. Our study contributes to~     the Centers for Disease Control and Prevention's efforts to combat obesity but in particular~     to the Centers for Disease Control's winnable battles (physical activity and obesity); the~     National Center for Chronic Disease Prevention and Health Promotion's strategic priorities~     around well-being, health equity, and evaluation and dissemination of environmental and~     systems-wide solutions to address public health problems; and the National Center for Chronic~     Disease Prevention and Health Promotion's domain around healthier work-site initiatives, the~     Centers for Disease Control and Prevention's efforts to improve nutrition and physical~     activity to prevent obesity, and reduction of cardiovascular disease risk. This study is a~     4-arm randomized controlled trial in which 344 employees of the City of Philadelphia,~     Independence Blue Cross, and South Eastern Pennsylvania Transportation Authority with initial~     Body Mass Index of 30 will be randomized to receive one of the following: 1) Daily lottery~     type incentives tied to achievement of weight loss goals (incentive arm); 2) individually~     tailored environmental strategies around food intake and physical activity (environmental~     arm); 3) a combination of incentives and environmental strategies (combined arm); or 4)~     standard employee wellness benefits and weigh-ins every 6 months (control arm). Phase I of~     the study (first 6 months) will focus on weight loss; Phase II (months 7-18) will focus on~     continued weight loss or maintenance for those who choose to maintain weight loss as opposed~     to continuing to try to lose weight; Phase III (months 19-24) will provide a period of~     post-intervention follow-up to measure sustainability of effects.~   "
52609|NCT02878330|"~     The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and~     antidrug antibody (ADA) response for MEDI8897 in healthy preterm infants who are between 29~     and 35 weeks gestational age and entering their first RSV season.~   "
52621|NCT02878174|"~     Two approaches such as ultrasound (US)-guided and prelocation techniques are possible when~     the internal jugular vein cannulation is attempted with US. This study is a clinical trial~     that compares the success rates of both techniques and shows the non-inferiority of the~     prelocation technique. However, during prelocation technique, rotated screen of the US is~     used instead of original screen. The angle of rotation is determined by the degree of~     rotation of US probe where an accelerometer is attached.~   "
52622|NCT02878161|"~     Rheumatoid arthritis (RA) is a chronic and disabling disease. tumor necrosis factor-a(TNF-a)~     inhibitors have demonstrated an outstanding performance in relieving joint inflammation and~     retarding bone erosion involved in RA. However, there is still about one-thirds of RA~     patients had a poor response to TNF α inhibitors. The Investigators hope to discover~     prediction protein with a domestic genetic background and finally establish prediction system~     with Chinese characteristics.~   "
52730|NCT02876757|"~     In December 2015, Health Canada issued a warning about a potential relationship between~     suicide and finasteride use and called for further research. No population based studies have~     assessed the risk of suicide with finasteride use, and this risk is not currently part of the~     product monograph. Furthermore, the link between depression and finasteride has not been well~     studied in the older population who are the primary users of this medication.~   "
52610|NCT02878317|"~     The purpose of the present study is to investigate the association between the accumulation~     of advanced glycation end-products (AGE) and adverse outcomes (e.g. death) in people~     receiving haemodialysis and peritoneal dialysis based in Royal Derby Hospital, as well as the~     impact of a dietetic intervention on AGE accumulation. AGE will be measured non-invasively in~     the skin using a technique called skin autofluorescence (SAF).~      The present study will be conducted in two parts:~      Study 1: this will be a prospective study where participants will be followed-up for up to~     five years. The research team will measure the accumulation of AGE in the skin using a quick~     (less than five minutes) and painless technique called SAF. This involves placing the forearm~     on a piece of equipment that shines a light on the skin and measures the amount of light that~     is reflected back. Participants will be asked to complete nutritional and quality of life~     questionnaires, measurements of weight, height, arm circumference and skinfold thickness~     (i.e. anthropometry), simple eyesight tests and blood tests.~      Study 2: observational non-randomized proof of principle study where malnourished dialysis~     participants will receive a dietitian supervised intensive nutritional support. Participants~     will be followed-up for 2 years and will receive precise oral and written instructions on how~     to comply with the intervention. Blood and eyesight tests, SAF measurements, anthropometry~     and nutritional and quality of life assessments will be conducted.~      In Studies 1 and 2, approximately two teaspoons of blood will be collected to measure AGE~     levels and do some additional blood tests to help us investigate the effects of AGEs on the~     body. If the participants agree, the investigators will also store some of the blood for~     future research.~   "
52611|NCT02878304|"~     The overall aim is to identify key determinants for recovery of hand function after stroke by~     applying newly developed hand function measures together with MRI measurements of the~     lesioned cerebral structures.~   "
52612|NCT02878291|"~     The purpose of this study is to evaluate safety of meningococcal ACYW135 polysaccharide~     conjugate vaccine in healthy volunteers aged above 3 Months~   "
52613|NCT02878278|"~     1. To compare the therapeutic effects, safety and the corresponding pharmacokinetics and~          pharmacodynamics between two different method of drug administration: 10mg, daily and~          30mg/d, twice every week, and find out the more effect way of Chidamide administration.~        2. To examine whether Chidamide could activate EB virus, and whether the above two~          different ways of administration are different in EB virus activation.~   "
52614|NCT02878265|"~     The aim of this study was to determine the effect of combining vitamin A (VA), zinc (Z) and~     multivitamins (MV- A, B1, B2, B6, B12, C, D and E) on malaria morbidity~   "
52615|NCT02878252|"~     The purpose of this study to determine the proportion and clinical characteristics of COPD~     patients with asthma symptoms (ACOS) and describe current practices in diagnosis and~     management in Viet Nam and Taiwan.~   "
52616|NCT02878239|"~     Static imaging has been commonly and clinically accepted to assess the severity of medial~     knee osteoarthritis (KOA), especially the radiography. Gait analysis has been adopted to~     evaluate the kinematic characteristics of the knees in patients with KOA. Most of the current~     studies focus on the sagittal plane of the knee, but very few of them focus on the frontal or~     horizontal plane. With the different severity of medial KOA, anatomical structures of the~     knees will change and influence kinematics of the knees, such as osteophytes and deformity.~     At present, there has been no study focusing on the relations between the imaging assessment~     of the severity and quantitative kinematics of medial KOA. The aim of the study is to explore~     the relationship between the imaging assessment based on the Kellgren-Lawrence Scores and in~     vivo 3D knee kinematic characteristics in Chinese patients with medial KOA during walking~     using a new portal gait system.~   "
52617|NCT02878226|"~     Uterine rupture (UR) is a serious, life-threatening obstetric complication. UR is associated~     with an increased risk of maternal and perinatal morbidity and mortality, particularly in~     developing countries compared to developed countries. UR occurs mainly as a consequence of~     poorly managed labour~   "
52618|NCT02878213|"~     The purpose of this study is to evaluate real-time gap detection using EPD D700 dielectric~     sensing compared with customary electrical isolation tests and Adenosine infusion at the end~     of the procedure. Furthermore, safety, usability and clinical applicability of the system for~     guided AF ablation will be confirmed.~   "
52619|NCT02878200|"~     Reactive treatment of household contacts of a confirmed malaria case has been shown to reduce~     infection prevalence since the former as they are at an increased risk of infection. However,~     implementing this on a programmatic scale poses significant pressure on the health system and~     may not be sustainable without the active involvement of the recipient community. This study~     investigates a novel approach to reducing residual malaria transmission that combines the~     elements of active community involvement in reactive treatment of household contacts of a~     clinical case reporting at a health facility. The investigators hypothesize that in areas of~     low transmission (prevalence of infection ≤10%), most asymptomatic carriers are clustered~     around clinical malaria cases in the same households. Also, targeting individuals sharing a~     sleeping area with diagnosed malaria case will reduce parasite carriage in the community.~     This is a cluster-randomized trial where villages in Central and Upper Baddibu, North Bank~     East Region of The Gambia, are randomized to receive either reactive treatment of household~     contacts following a confirmed case of malaria or standard care, i.e. treatment of index case~     only. Formative research into community perception and reaction to self-administered~     treatment will be used to generate, adapt and evaluate messages that encourage adherence and~     compliance to treatment. This will be tested in the first year of the implementation, and~     findings used to develop a final model of messages to be implemented in the second year of~     the study. The primary outcome is the prevalence of malaria infection, determined by~     molecular methods, in all age groups at the end of the second intervention year and the~     incidence of clinical malaria during the transmission season.~   "
52620|NCT02878187|"~     Bleeding is the most significant cause of maternal death worldwide with more than half of~     those occurring within the first day of delivery. About 10.5% (some estimate as high at~     12-17%) of live births world-wide, or about 14 million births, are complicated by postpartum~     hemorrhage; a woman dies every 4 minutes from postpartum hemorrhage. Uterine atony and~     placenta accreta are the two leading causes of postpartum hysterectomies with up to 64% of~     Cesarean hysterectomies done for abnormally adherent placentation~   "
52623|NCT02878148|"~     Prospective single centre study aiming at validating a conditional imaging strategy for~     diagnosis of suspected kidney stone.~      Consecutive Emergency department patients referred to the medical imaging department for~     exploration of a suspected acute uncomplicated renal colic will undergo the following~     interventions : systematic plain abdominal Xray, systematic ultrasonography and systematic~     unenhanced CT (with a reduced dose scan), in addition to clinical examination and assessment~     of body mass index and the Sex, Timing, Origin, Nausea, Erythrocytes (STONE) clinical~     prediction score for symptomatic stone.~      Patients will be followed up at 1 month to record the need for urologic intervention and its~     type.~      The performances of different conditional imaging strategy for the diagnosis of suspected~     renal colic will be assessed retrospectively. The conditional strategies tested will be based~     on the patient's stone score and BMI and targeted use of combined plain X-ray and~     ultrasonography and/or unenhanced CT.~      The reference diagnosis for renal colic will be made according to the finding of a ureteral~     stone or indirect signs of urolithiasis at unenhanced CT.~   "
52624|NCT02878135|"~     intrauterine device insertion requires use a vulsellum to stabilize the cervix. Patient's~     often complain that its placement is one of the most uncomfortable parts of this procedure~   "
52625|NCT02878122|"~     Epithelial ovarian cancer (EOC) has a poor prognosis. EOC management requires debulking~     surgery and chemotherapy based on taxol and carboplatine. Initial response is often good, but~     most often a recurrence occurred in the first 18 months. Early recurrence signs~     chemoresistance and palliative treatment. The study of predictive clinical or biological~     factors is required to adapt therapeutic and develop new treatments.~   "
52626|NCT02878109|"~     This study is conducted to evaluate dynamic contrast-enhanced MRI to quantify the efficacy of~     trans-arterial chemoembolization by comparing imaging results before and after treatment for~     at least one hepatic tumor.~   "
52627|NCT02878096|"~     The primary objectives of the study are:~        -  To determine the absolute bioavailability of SK-1404~        -  To assess the mass balance recovery after a single oral (PO) dose of carbon-14~          (14C)-SK-1404~        -  To provide plasma, urine and faecal samples for metabolite profiling and structural~          identification~      The secondary objectives of the study are:~        -  To determine the routes and rates of elimination of [14C]-SK-1404~        -  To identify the chemical structure of each metabolite with an exposure (AUC) of more~          than 10% of circulating total radioactivity~        -  To explore the intravenous (IV) pharmacokinetics (PK) of [14C]-SK-1404~        -  To further explore the PO PK of SK-1404~        -  To provide additional safety and tolerability information for SK-1404~   "
52628|NCT02878083|"~     The main objective of this project is to demonstrate the feasability of an endomicroscopic~     biomarker of efficacy of vedolizumab and adalimumab, in Ulcerative colitis (UC) by coupling~     vedolizumab to a fluorescent component, FITC (Fluorescein isothiocyanate) , and adalimumab to~     rhodamine.~      This project should allow the development of a biomarker of therapeutic efficacy for~     vedolizumab and adalimumab that can be used in a single time-frame in vivo in humans, while~     respecting manufacturing standards and Good manufacturing procedures.~   "
52629|NCT02878070|"~     My Care My Call (MCMC) is an innovative, peer-led telephone intervention designed to empower~     adults with chronic spinal cord injury (SCI) in the self-management of their primary health~     care needs to prevent secondary conditions. In a randomized controlled trial, participants~     assigned to the MCMC intervention receive tapered calls from a Peer Health Coach (PHC) for~     six months. PHCs are experienced, empathetic peer mentors living with SCI who act as~     supporters, role models, and advisors, providing goal-setting support, motivation, education,~     and resource referral to participants. Participants complete surveys at baseline, 2, 4, and~     6-months, as well as qualitative exit phone interviews.~      It is hypothesized that MCMC will: 1) Increase participants' self-advocacy in health care~     interactions as reflected in increases in three domains of self-advocacy: assertiveness,~     illness education, and potential for mindful non-adherence, 2) Increase participants'~     self-efficacy for health care navigation, preference for involvement in, and satisfaction~     with their primary care physician (PCP), and 3) Increase health related quality of life and~     medical social support compared with those receiving usual care. Additional secondary~     hypotheses state that the MCMC intervention will increase access to primary care and use of~     preventive screening services compared with those receiving usual care.~   "
52630|NCT02878057|"~     The treatment of the patients with recurrent and metastatic breast cancer remains a major~     problem. There is still a lack of effective targeted therapy for Her-2 negative breast~     cancer.Based on the present researches on the anti-angiogenesis drugs in advanced breast~     cancer, the investigators believe that it is necessary to further explore the efficacy and~     safety of apatinib in advanced breast cancer.~   "
52631|NCT02878044|"~     The objective of this project is to evaluate a treatment decision aid for patients with low~     risk thyroid cancer.~   "
52632|NCT02878031|"~     This one-arm safety intervention study is aimed at increasing access to treatment of~     pneumonia by training CHWs, locally referred to as Community Oriented Resource Persons~     (CORPs), to manage chest indrawing pneumonia using oral amoxicillin, conducting follow-ups~     and recording their findings in case report forms. CORPs will also be involved in improving~     care seeking for pneumonia in children by training them to conduct health education sessions~     for men and women in their respective communities.~      The primary objective is to assess if CORPs can safely and appropriately manage chest~     indrawing pneumonia in 2-59 month old children, and refer children with danger signs. The~     primary outcomes will be the proportion of children under five with chest indrawing pneumonia~     who were managed appropriately by CORPs and the clinical treatment failure of chest indrawing~     pneumonia. Secondary outcomes will include proportion of children with chest indrawing~     followed up by CORPs on day 3 and caregiver adherence to treatment for CI, and clinical~     relapse of pneumonia between day 7 to 14 among children whose signs of pneumonia disappeared~     by day 6. Approximately 308 children 2-59 months of age with chest indrawing pneumonia would~     be needed for this safety intervention study.~   "
52682|NCT02877381|"~     To determine the optimal dosing regimen and route of administration of tranexamic acid (TXA)~     [single dose intravenous (IV), double dose intravenous, intravenous + topical, and oral~     repeated dosing] to minimize post-operative blood loss and transfusion requirements following~     revision total knee arthroplasty (RTKA).~   "
65571|NCT02708719|"~     The purpose of this study is to determine the minimal important difference (MID) for the~     1-minute-sit-to-stand-test (STST) with an anchor-based method.~   "
52633|NCT02878018|"~     Henoch-Schonlein purpura nephritis(HSPN) is one of the most common secondary~     glomerulonephritis in children. A large, prospective, multicenter cohort study is being~     conducted in three institutions. Eligible Henoch-Schönlein purpura nephritis children will be~     classified as the experimental group (n=300) and the control group (n=300) based on the~     interventions they receive. Patients taking Chinese herbal formula will be in the~     experimental group, and those taking Western medicine will be in the control group. The~     entire study will last 60 weeks, including a 12-week observation period and a followup at 12~     months.~   "
52634|NCT02878005|"~     The intubating Laryngeal Tube Suction-Disposable is a new version of the Laryngeal~     Tube-Suction. It has a ventilator channel with a 13.5mm internal diameter, which enables the~     passage of an Endotracheal Tube either blindly or with fiberoptic guidance.This study was~     designed to assess the success rate of blind and fiberoptic endotracheal intubation using~     iLTS-D, in comparison with the and Ambu® AuraGain™ in adult patients.~   "
52635|NCT02877992|"~     The purpose of this project is to study the presence of expression differences - at RNA and~     protein level - of different members of the tachykinin family and kisspeptin and their~     receptors, between fertile women and infertile patients with different etiologies.~   "
52636|NCT02877979|"~     A double-blind, randomised, placebo-controlled, dose escalation trial to evaluate the safety~     and to assess local and systemic pharmacokinetics of ds003 vaginal tablets administered to~     healthy HIV-negative women.~   "
52637|NCT02877966|"~     The primary objectives of this study are to evaluate the effects of an amino acid mixture~     (Amixea) on the body composition as assessed by DXA, and on QMVC as assessed by strain gauge,~     in advanced NSCLC patients, compared to placebo, after 10 weeks of treatment.~      Secondary objectives are to evaluate the activity of Amixea on the degree of protein~     synthesis, on the nutritional risk and status and quality of life in advanced NSCLC patients,~     compared to placebo, after 10 weeks of treatment. In a small subsample, body composition will~     be evaluated opportunistically from clinically available CT scans.~      Adherence to, and patient satisfaction of treatment will be evaluated as exploratory~     objectives of this study. Finally, the overall safety and product tolerability will be~     evaluated.~   "
52638|NCT02877953|"~     The investigators conducted a randomized controlled trial to describe if multidisciplinary~     and patient-centered transitional care interventions for patients with cirrhosis post-TIPS~     can improve compliance behavior and reduce complications post-TIPS after discharge.~   "
52639|NCT02877940|"~     The Aim of the study is to compare the clinical performance of p-LMA, i-gel and LTS-D in~     terms of the efficacy and safety in anaesthetized patient on Mechanical ventilation~     undergoing elective surgical procedure.~   "
52640|NCT02877927|"~     The purpose of this study is to evaluate the safety and efficacy of omadacycline as compared~     to linezolid in the treatment of adults with acute bacterial skin and skin structure~     infections.~   "
52641|NCT02877914|"~     This study will use a two-stage random sampling design to create a nationally representative~     sample of patients with heart failure (HF) in China. The investigators sought to describe the~     clinical profiles, to assess treatment patterns and in-hospital outcomes for HF, and to~     identify targets for care quality improvement.~   "
52642|NCT02877901|"~     It is a prospective randomized- placebo control crossover study to evaluate the effect of~     long acting tolterodine (anticholinergic) in improving and treating nocturnal incontinence in~     patient after radical cystectomy and orthotopic urinary diversion. patients will be randomly~     allocated into two groups. one will receive the drug and the other will receive placebo.~     continence status will be evaluated before and 4 weeks after treatment by the number of pads~     used and the ICIQ-UI short form questionnaire. This is followed by two weeks of drug washout~     then reevaluation of the continence status and each group will be crossed over and lastly~     will be evaluated again.~   "
52643|NCT02877888|"~     Despite the availability of free health dental service in Sri Lanka, the prevalence and~     severity of dental caries among 6year old school children stand at a very high level~     according to the results of national oral health survey in 1983/84, 94/95 and 2002/2003.~     Professional fluoride varnish application has become popular as variety of studies has found~     that it is an efficient method in reducing dental caries. The simplicity of its application~     makes it very suitable and practical for use in dental clinics and outreach dental services,~     especially in young children.~      Aim of this study is to evaluate the cost effectiveness of 6 monthly application of sodium~     fluoride varnish in prevention of dental caries in permanent incisors and molars in children~     between 6 and 7 years in a suburban setting in Sri Lanka. This will be a double-blind,~     randomized controlled trial. A sample of school children (6-7 years) will be randomized into~     varnish and control groups. All the children will receive routine caries preventive measures~     of oral hygiene instructions, dietary advice and professional cleaning. Children in varnish~     group will receive fluoride varnish professionally applied after prophylaxis every 6 months.~     Clinical examinations of all children will be performed at the beginning of the study and 1~     year and 2 years later. All the caries at the dentinal level of both groups will be~     stabilized with temporary restorations at the beginning. During this period, each school will~     be visited four times at 6-month interval for recruitment, dental examinations, and fluoride~     varnish applications. Recruited children will be randomly assigned to either a treatment (5%~     NaF varnish) or a control group. Caries examinations will be conducted using the~     International Caries Detection and Assessment System (ICDAS). The cost for the dental team's~     school visits; cost involved in the treatment of dental caries throughout the course of the~     study in both groups will be evaluated and compared at the end of the study. The sample size~     is calculated as 160 each arm to detect 5% caries change with 80% power. Analysis The effect~     of intervention will be measured by number of caries prevented. New caries in the usual care~     and intervention group will be calculated after the completion of the study. The costs for~     intervention will be estimated. The costs will be estimated for the dental material, time for~     human resources and indirect costs.~   "
52644|NCT02877875|"~     The study will compare the impact of Child STEPs (see Weisz et al., 2012) versus usual~     school-based therapy on students' mental health and school-related outcomes, and test whether~     changes in school outcomes are mediated by changes in student mental health.~   "
52645|NCT02877862|"~     This innovative project seeks to harness mobile phone technology as a means to take~     preventive health care to a new level among ovarian cancer survivors. Using the Fogg~     Behavioral Model, developed from the concept of persuasive technology, this study proposes to~     develop the Mobile Application for Genetic Information on Cancer (mAGIC) intervention to~     motivate ovarian cancer survivors to undergo genetic counseling. The overall study objective~     is to develop and assess the feasibility and effectiveness of a theory-based intervention~     aimed to encourage ovarian cancer survivors to receive genetic counseling~   "
52697|NCT02877186|"~     This pilot study is being conducted to evaluate whether consumption of diet soda sweetened~     with sucralose and acesulfame-potassium leads to changes in the gut microbiota. Following a~     one week run-in period, healthy, young adults are randomized to consume either diet soda or~     carbonated water (control) three times per day for one week. Stool and urine samples are~     collected at baseline, following the run-in, and after the one-week intervention.~   "
52646|NCT02877849|"~     Due to the relapsing nature of alcoholism, excessive alcohol consumption represents a~     significant cost to US society ($249 billion in 20101). About 64% of those entering treatment~     will relapse within one year. New interventions targeting the underlying brain biomarkers of~     relapse vulnerability hold significant promise in reducing this critical public health~     problem. Using resting functional magnetic resonance imaging (fMRI) we have identified brain~     biomarkers that support long-term abstinence and brain biomarkers that predict relapse. Our~     data point to specific brain biomarkers that index higher relapse vulnerability at 11 weeks~     of abstinence. Many individuals, however, have already relapsed by this time. It is unknown~     whether these biomarkers can be identified earlier during the recovery period. We need to~     investigate whether this biomarker of relapse vulnerability can be identified during earlier~     stages of abstinence. Earlier identification of this biomarker will give valuable information~     for timely targeted interventions (e.g. closer monitoring, longer stay in treatment program,~     neuromodulation), increasing the chances of maintaining abstinence. The overall objective of~     this study is to identify biomarkers of relapse during early abstinence (2-3 weeks of~     abstinence). A secondary objective is to evaluate whether non-imaging measures such as~     craving6 and executive function7 add value to prediction models. Findings from this proposal~     will provide insight into the neurobiology of relapse vulnerability that will inform new~     treatment strategies needed to improve treatment outcome.~   "
52647|NCT02877836|"~     The aim of this study is to evaluate the organization of the motor circuit in a group of~     patients suffering from dystonia compared with a group of healthy controls. Deep Brain~     stimulation is a functional neurosurgery technique consisting in neuromodulation of the motor~     circuit that has been applied to dystonia. The efficiency of this technique depends on the~     relative preservation of the function and the structure of the motor network .~      The assessment of neuronal circuit by advanced techniques of functional neuroimaging in this~     study might contribute to expand our understanding of the abnormalities in motor circuit~     activation and the integrity of CNS structure underlying dystonia. This study might~     contribute therefore to the refinement of Deep brain stimulation indications and techniques~     in complex dystonia syndromes~   "
52648|NCT02877823|"~     Pediatric antipsychotic treatment is associated with significant obesity-related side~     effects, including weight gain, increased blood sugar, abnormal cholesterol, and risk of new~     onset diabetes. Antipsychotic-induced weight gain is most prominent over the first 6 months~     of treatment. In this study, youths who are started on antipsychotic medication are~     identified for a health intervention to minimize antipsychotic-induced weight gain and also~     have collateral health benefits for the child's parent. Children are identified through a~     Medicaid medication authorization program which provides a complete list of eligible youth.~     Youth-parent pairs will be enrolled. All youth and their parents enrolled in this study are~     offered healthy lifestyle education with simple targets to reduce risk of~     antipsychotic-induced weight gain (e.g. reduce sugar sweetened beverage intake, engage in 1~     hour of daily physical activity). Half of families will also receive 1) home delivery of~     bottled water, 2) provision of a child pedometer, and 3) health coaching/support from a~     telephone-delivered, parent peer program (Family Navigator). Home water delivery has been~     demonstrated to dramatically reduce sugar sweetened beverage intake in general pediatric~     studies. Child pedometers will be used to encourage parent monitoring of child physical~     activity. Parent peer support will be provided through a Family Navigator, who is a parent~     with lived experience raising a child with special mental health needs. Family Navigators~     address practical barriers to lifestyle changes for low income families (e.g. identify safe~     environment for physical activity, support access to food pantries) and provide emotional~     support for parents dealing with competing child health priorities (emotional stability,~     obesity health concerns). Family Navigator contact is exclusively by phone, and all study~     visits will occur in the home. The Family Navigators are supervised by a child mental health~     expert team, with an on-call licensed clinician available to address any after hours/weekend~     urgent concerns. The impact of this intervention will be studied on both child and parent~     health outcomes (weight, blood pressure, sugar sweetened beverage consumption), child~     physical activity, as well as parent behaviors associated with child healthy lifestyle~     changes (e.g. modeling healthy behaviors, monitoring child activity). Assessment of the~     impact of this healthy lifestyle intervention on other obesity related outcomes that are~     monitored through blood work (e.g. blood sugar, cholesterol). These labs are obtained by~     community prescribers as part of standard of care and submitted to Medicaid as required for~     ongoing approval. No blood work will be done in this study protocol. Child lab results will~     be requested from the Medicaid pre-authorization program.~   "
52649|NCT02877810|"~     The purpose of this study is to determine the impact of an existing tele-emergency care~     network on quality of care, appropriateness of care utilization, patient safety (medication~     errors), and cost effectiveness compared to telephone consultations from a healthcare system~     prospective.~   "
52650|NCT02877797|"~     Aim of the present study is the evaluation of the diagnostic value of a cap assisted upper~     GI-endoscopy compared to a standard upper GI-endoscopy regarding the visualisation and~     evaluation of the papilla duodeni major.~   "
52651|NCT02877784|"~     Oculopharyngeal muscular dystrophy (OPMD) is a rare myopathic disease that results in~     progressive degeneration of the oral and pharyngeal muscular, resulting in severe dysphagia~     and dysarthria. OPMD is considered a rare disease; therefore, limited research is available~     on the natural progression of the disease or the utility of biomarkers to identify swallowing~     impairment. The aim of this study is:~        1. To identify accurate, reliable and non-invasive clinical markers of swallowing~          impairment~        2. To determine the discriminate ability of these markers to identify impairments in~          swallow safety and swallowing efficiency.~   "
52652|NCT02877771|"~     The goal of this study is to assess the functionality of an integrated predictive low glucose~     suspend system designed to minimize the incidence and duration of hypoglycemia by suspending~     insulin delivery if hypoglycemia is projected.~   "
52653|NCT02877758|"~     Tomorrowlabs has developed a revolutionary cosmeceutical formulation to rejuvenate aging~     skin. Tomorrowlabs is conducting this research to study whether this cosmeceutical can reduce~     the visible signs of cutaneous aging.~   "
52654|NCT02877745|"~     In patients undergoing elective coronary artery bypass grafting (CABG) surgery, coronary~     artery disease, sleep-disordered breathing (SDB), atrial fibrillation (AF) perioperative~     atrial fibrillation and complications will be assessed. The primary objective is to~     determine, whether SDB patients have a higher rate of Major Adverse Cardiac and~     Cerebrovascular Events (MACCE) within 30 days after surgery compared to those without SDB.~   "
52655|NCT02877732|"~     This is a prospective multi-center cohort feasibility and exploratory study.~   "
52656|NCT02877719|"~     The aim of this study is to explore the impacts of poverty and income disparity on the~     psychological well-being of Hong Kong Chinese children.~   "
52657|NCT02877706|"~     CARMEN is a clinical registry of all incident adult Immune thrombocytopenia (ITP) and~     Autoimmune Hemolytic anemia (AIHA) patients in the Midi-Pyrenees region (South of France). It~     is aimed at describing ITP and AIHA clinical features, assessing the risk-benefit ratio of~     second-line treatments (SLTs) and adherence to guidelines for ITP and AIHA management.~   "
52658|NCT02877693|"~     to assess the clinical performance of the St. Jude Medical™ MR Conditional ICD System in~     patients undergoing an elective thoracic MRI scan.~   "
52659|NCT02877680|"~     Type 1 diabetes (T1D) management is particularly challenging during adolescence as~     responsibility for management begins to shift from parents to youth, and positive family~     teamwork is critical to achieving optimal diabetes outcomes. Existing behavioral family~     interventions for T1D are beneficial but have limited potential for translation to clinical~     practice, and universal preventive approaches designed to explicitly promote existing T1D~     management strengths are needed. Ultimately, the goal of this line of research is to validate~     brief, convenient, and helpful tools that families of all adolescents with T1D can use to~     strengthen positive family teamwork and ultimately promote optimal diabetes health outcomes.~   "
52660|NCT02877667|"~     Study of new acoustic wave device as an accessory to laser treatment in tattoo reduction.~   "
52661|NCT02877654|"~     Increased intestinal permeability is one of the main pathophysiological mechanisms involved~     in irritable bowel syndrome. The expression of some intestinal tight junction proteins is~     decreased mostly in IBS-diarrhoea patients. This decrease is correlated with increased~     intestinal permeability. Currently, no test used in clinical practice could assess intestinal~     permeability.~      We hypothesis plasmatic zonulin could reflect intestinal permeability in IBS patients.~   "
52662|NCT02877641|"~     This phase IIb randomized trial studies how well cholecalciferol (vitamin D3) supplementation~     works in strengthening inspiratory muscles in cholecalciferol-deficient patients with chronic~     obstructive pulmonary disease (COPD). Cholecalciferol supplementation may help reduce the~     risk of developing lung cancer and strengthen the diaphragm in cholecalciferol-deficient~     patients with COPD.~   "
52663|NCT02877628|"~     Prospective, non-randomized, open Pharmacokinetic-Pharmacogenetic-Pharmacodynamic monocentric~     study. Donor and recipient CYP3A5 genotype and recipient ABCB1 will not be communicate to~     clinicians or patients during the study.~   "
52664|NCT02877615|"~     The purpose of this study is to assess the efficacy and safety of S 44819 in enhancing~     functional recovery after an ischemic stroke.~   "
52665|NCT02877602|"~     This is a qualitative study to determine which factors affect the patient experience of~     having a liver MRI, what information patients would like to receive after their MRI, and how~     patients would like this information communicated to them.~   "
52666|NCT02877589|"~     Immunosuppression induced by cancer treatment increases the risk of hepatitis B virus (HBV)~     and hepatitis C virus (HCV) reactivations. These viral reactivations may be asymptomatic but~     can cause fulminant hepatitis and death. More, they impact the treatment of cancer by~     chemotherapy delays or stops. They can occur during cancer treatment but also after stopping,~     at the immunological rebound. This risk persists for at least 6 months after cessation.~      The key to the prevention, and the first step, is serological testing. It is also the main~     problem because international recommendations diverge. Hepatologists and infectious disease~     specialists recommend routine screening HBV of all candidates for immunosuppressive therapy.~     These recommendations are more implemented by hematologists, given the frequency of HBV~     reactivation associated to haematological malignancies. Clinical oncology societies~     guidelines suggest a selective screening in case of risk factors of hepatitis B or in~     patients with a strong immunosuppression (such as anti-CD20 based treatment, stem cell~     transplantation or lymphoma treatment).~      The consequence of these differences is a sub-screening by oncologists and the persistence of~     fatal cases. Screening before cytotoxic chemotherapy for solid tumors in countries with low~     prevalence of HBV and HCV virus is questionable. Selective screening of patients at risk HBV~     and HCV can be assessed.~   "
52667|NCT02877576|"~     The purpose is to evaluate specific capacities of face detection of individual neurons by~     comparison with their capacity of object detection in medial temporal lobe and ventral~     temporal cortex in epileptic patients.~      Secondary purpose is to evaluate specific capacities of detection of known faces of~     individual neurons by comparison with their capacity of detection of unknown faces in medial~     temporal lobe and ventral temporal cortex in epileptic patients.~   "
52668|NCT02877563|"~     This study represents an important step to validate the use of contrast-enhanced ultrasound~     (CEU) as a clinical research tool that can be used as a biologic readout of new therapies for~     Peripheral Artery Disease (PAD), and as a clinically-reasonable method for assessing impact~     of revascularization. The primary aim is to establish that CEU limb perfusion imaging can be~     used to accurately assess therapeutic improvements in tissue perfusion that are linked to~     symptom improvement.~   "
52669|NCT02877550|"~     Follicular lymphoma (FL) is an indolent yet incurable lymphoma characterized by initial~     responses to standard therapies, invariably followed by shorter disease free intervals.~     Obinutuzumab, a novel type II, anti-CD20 monoclonal antibody has been approved in combination~     with chlorambucil for the treatment of previously untreated chronic lymphocytic leukemia~     (CLL) and in combination with bendamustine followed by obinutuzumab alone for FL who did not~     respond to, or who progressed during or after treatment with rituximab or a~     rituximab-containing regimen, or in relapse after such treatment. Additionally, venetoclax, a~     small molecule Bcl-2 inhibitor, showed single agent activity in relapsed/refractory (R/R) CLL~     and other B-cell lymphomas, including R/R FL. Preclinical evidence suggests a synergism of~     the two drugs in vitro as well as in different lymphoma in vivo models. Based on single agent~     clinical activity and on the preclinical data of the combination of both drugs and aiming to~     develop a new chemotherapy-free combination regimen, this trial plans to evaluate the~     combination of obinutuzumab and venetoclax in previously untreated FL patients in need of~     systemic therapy. This phase I study will provide information on the safety and tolerability~     together with evidence of preliminary antitumor activity. Combination treatment consists of a~     6 cycles of 28 days each. The combination therapy is followed by a 2 years maintenance with~     obinutuzumab. Dosing of obinutuzumab is as per Swissmedic approval in FL.Venetoclax will be~     administered in different dose levels according to the trial design.~   "
52670|NCT02877537|"~     The purpose is to characterize the change of respiratory admittance induced by salbutamol~     inhalation in children and young adults. A variation threshold will be fixed to distinguish~     asthmatic and healthy subjects.~      This project could allow a better identification of asthmatic individuals needing a~     treatment, a reduction of morbidity of asthma, a reduction of unnecessary treatments~     administered in individuals with respiratory but not asthmatic symptoms, a better~     comprehension of bronchial hyperreactivity and its role in asthmatic disease.~   "
66310|NCT02699086|"~     The purpose of this study is to evaluate the safety and efficacy in adult patients with~     Attention-Deficit Hyperactivity Disorder (ADHD).~   "
52671|NCT02877524|"~     The clinical course of chronic obstructive pulmonary disease (COPD) is associated with~     recurrent episodes of exacerbation that results in respiratory failure. The treatment of~     respiratory failure is supportive and involves inhalation bronchodilators along with systemic~     steroids. In few cases the management of acute respiratory failure requires positive pressure~     ventilation (non-invasive or invasive). The use of NIV in acute exacerbation of COPD has~     resulted in significant reduction in morbidity and mortality. Although pressure support~     ventilation (PSV) allows the patient to influence the breathing pattern, ventilator-cycling~     criteria may worsen the patient-ventilator interaction, and severe asynchronies occur in up~     to 43% of patients undergoing NIV for ARF. Adaptive support ventilation (ASV) is a newer mode~     of ventilation that incorporates feedback mechanisms and thus provides a stable minute~     ventilation. We hypothesize that the use of ASV as a mode during ventilation using NIV in~     patients with acute exacerbation of COPD may result in reducing the duration of ventilatory~     support, need for intubation, and duration of intensive care unit (ICU) and hospital length~     of stay, when compared with PSV mode of NIV ventilation.~   "
52672|NCT02877511|"~     To assess the safety of a sunscreen product under supervised outdoor-use conditions~   "
52673|NCT02877498|"~     Neuroparalytic snake envenomation results in severe muscle weakness and respiratory failure.~     Treatment requires administration of anti-snake venom and supportive care in the form of~     invasive mechanical ventilation. Whether using adaptive support ventilation (a closed loop~     mode of ventilation) in comparison to volume controlled ventilation will shorten the duration~     of ventilation remains undetermined. The current study is planned to compare adaptive support~     ventilation (ASV) mode of ventilation versus volume controlled ventilation (VCV) during~     invasive mechanical ventilation for the management of respiratory failure secondary to~     neuroparalytic snake envenomation.~   "
52674|NCT02877485|"~     The purpose of this project is to determine if intranasal corticosteroids have an effect on~     nasal obstruction in patients with nasal septal deviation.~   "
52675|NCT02877472|"~     To confirm 1) whether, compared with core decompression alone, core decompression with porous~     tantalum rod implantation improves the hip joint function of patients with avascular necrosis~     of the femoral head after femoral neck fracture surgery, 2) whether porous tantalum rod shows~     favorable biocompatibility with the human body, and 3) whether this treatment method is~     feasible for treating avascular necrosis of the femoral head after femoral neck fracture~     surgery.~   "
52676|NCT02877459|"~     A multicenter, prospective, single-arm clinical investigation to evaluate the short term and~     long term safety of a modified staged treatment algorithm using the AeriSeal System.~   "
52677|NCT02877446|"~     Chronic heart failure is a common disease. It is also a serious disease with a mortality of~     50% at 5 years, representing a significant cost in terms of public health expenditure.~      Heart transplantation represents the gold standard of care for terminal heart failure~     patients reached the end of the disease despite optimal medical and surgical management of~     their disease, with a survival rate of transplant patients by 90% at 1 year and 82% at 3~     years.~      Long term LVAD are an innovative technology available for more than a decade, developed in~     part because of the shortage of cardiac grafts and high mortality among patients waiting for~     transplants due to an important pending.~      This technique is used substantially only for ten to fifteen years in the world. Survival~     after implantation of latest devices reaches 80% at 1 year.~      In France, this technique is intended for patients with terminal heart failure who ended~     different pharmacological and invasive therapeutic resources available.~      Currently, academic centers that offer the possibility of long-term LVAD support are~     organized unicentric in order to centralize specialized care for these patients.~      Indeed, patients candidates for the establishment of a long-term LVAD are rigorously selected~     to ensure an acceptable survival.~      However, practices vary considerably from one center to another in particular regarding:~        -  Implantation indications,~        -  Pre-implantation patient assessment,~        -  Monitoring,~        -  Implementation of pharmacological treatments, particularly anticoagulants or~          betablockers.~   "
52678|NCT02877433|"~     This study aims to compare the clinical performance of 4 mm short implants supporting~     cross-arch fixed reconstructions in the edentulous mandible either with a combination of two~     short implants as distal support and two implants of conventional length placed in the~     interforaminal region, or with a combination of four short implants as distal support and two~     interforaminal implants of conventional length.~   "
52679|NCT02877420|"~     The investigators aim to test a curriculum of non-technical skills (NTS) training for~     simulation-based training of colonoscopy. There is no known literature to date on the optimal~     approach on how to teach NTS in endoscopy. The objectives are to evaluate a simulation-based~     curriculum to teach NTS, to explore the relationship between NTS and other domains of~     competency, and understand how NTS are acquired in endoscopic training.~   "
52680|NCT02877407|"~     -  objective: aimed to compare laparoscopic/robot-assisted hysteropexy with vaginal~          hysterectomy for uterine prolapse~        -  prospective randomized clinical trial~        -  patient~             1. 60yrs or more women and~             2. POP-Q stage II with symptom or POP-Q III, IV regardless of symptom~        -  number of patient: 146~        -  randomize: laparoscopic/robot-assisted hysteropexy vs. hysterectomy~        -  follow up: postoperative 1 year~        -  primary endpoint: recurrence rate~             1. recurrence of uterovaginal prolapse POP-Q stage II-IV~             2. recurrence of associated symptom~        -  secondary endpoint~             1. postoperative 1 year QOL, degree of satisfaction evaluation~             2. operative time, estimated blood loss~             3. hospitalization period, postoperative pain, return to normal activity~   "
52681|NCT02877394|"~     Constipation is a very common problem. Western style toilets that are nearly universal in the~     United States require the person to sit on the toilet. However, results from uncontrolled~     studies suggests that a squatting posture (as prevalent in many foreign countries) may be~     better at facilitating evacuation compared to a Western style commode. One uncontrolled,~     unpublished study suggests that a footstool improved bowel symptoms in nearly 98% of 153~     constipated participants. Hence, the investigators propose to evaluate the benefits of a~     footstool on symptoms and anorectal functions in constipated patients. Hypothesis: the~     regular squatting assist device (7 inches) but not a sham device (2 inches tall) will improve~     symptoms of constipation.~   "
66686|NCT02694081|"~     The Advantages and Disadvantages Between Uncut Roux-en-Y Reconstruction and Billroth II~     Reconstruction After Laparoscopy-assisted Distal Gastrectomy for Gastric.~   "
52683|NCT02877368|"~     The treatment of advanced gastrointestinal stromal tumours (GIST) has shifted since the~     arrival of targeted therapies. Imatinib is an active multikinase inhibitor that mainly~     targets C-kit tyrosine-kinase receptors and the platelet-derived growth factor receptor.~     Imatinib use has been validated for adjuvant and palliative therapy settings. Imatinib is~     generally well-tolerated and known to improve performance status but up to 16% grades 3-4~     toxicities, leading to at least 40% withdrawals, have been reported.~      Recently, in oncology, sarcopenia was shown to be a predictor of severe toxicity patients~     included in phase 1 trials, suggesting that it should be considered an inclusion criterion~     for such studies. Sarcopenic patients had low performance status, shorter survival, more~     chemotherapy toxicities and post-operative infections, and longer post-operative~     hospitalization times. In addition, exposure to tyrosine-kinase inhibitors (e.g. sorafenib or~     sunitinib) has been associated with dose-limiting toxicity (DLT) in patients with renal cell~     or hepatocellular carcinomas.~      Computed tomography (CT) scans acquired during routine care have been validated as an~     accurate and robust imaging technique to evaluate sarcopenia in cancer patients.~   "
52684|NCT02877355|"~     This trial is conducted in Europe. The aim of this trial is, to investigate the effect of~     upper gastrointestinal disease on the pharmacokinetics (the exposure of the trial drug in the~     body) of oral semaglutide in subjects with type 2 diabetes.~   "
52685|NCT02877342|"~     A prospective observational study using an interrupted time-series design to evaluate the~     effect of pre-hospital notification on trauma patients arriving at a trauma centre by~     ambulance, in India~   "
52686|NCT02877329|"~     Randomized trial comparing internet-delivered ACT with therapist support against waiting list~     for persons with hearing loss and comorbid psychological distress~   "
52687|NCT02877316|"~     Background: Persons with a past episode of self-harm or severe suicidal ideation are at~     elevated risk of self-harm as well as dying by suicide. It is well established that suicidal~     ideation fluctuates over time. Safety plans in paper format are mandatory part of the~     treatment regime in the suicide preventive clinics in Denmark. The aim of the trial is to~     compare the paper version of the safety plan with a new-developed app in reducing suicide~     ideation and other symptoms, as an add-on to the supportive psychotherapy delivered in the~     clinics.~      Hypothesis: It is hypothesized that participants randomized to MYPLAN will have lower suicide~     ideation as well as improvements on the secondary outcomes than users who have the paper~     version.~      Methods: The trial is designed as a 2-arm observer-blinded parallel group randomized clinical~     superiority trial, where participants will either receive: 1) Experimental intervention: the~     safety plan provided as the app MYPLAN, or 2) Treatment as Usual: the safety plan in the~     original paper format. Both intervention groups will also receive standard psychosocial~     therapeutic care, up to 8-10 sessions of supportive psychotherapy.Based on a power~     calculation a total of 546 participants, 273 in each arm will be included. They will be~     recruited from national suicide preventive clinics. Follow-ups will be conducted at 3, 6, 9,~     and 12 months after date of inclusion.~      Participants, inclusion and exclusion criteria: There is no age restriction on participation~     in the study and all participants will be recruited from the suicide prevention clinics in~     Denmark. These clinics are highly specialized outpatient care centers, offering short-term~     supportive psychotherapy and social counselling for suicidal patients. In order to~     participate in the study, participants must have a smartphone (IPhone or android phone) and~     understand sufficient Danish to use MYPLAN. Persons having a particularly severe alcohol or~     substance abuse disorder, which might inflict with skills of orientation and memorywill not~     be offered participation in the RCT.~      Outcomes Patient reported outcomes (PROM) are collected at baseline and follow-up through~     self-administered tablet/internet-based questionnaires. Primary outcome is suicide ideation.~     Secondary outcomes are:, hopelessness, depressive symptoms, quality of life, and modified~     CSQ-8.~      Statistical analysis: Data analysis will be based on intention-to-treat principle. We will~     examine this using repeated measurement in mixed models. Missing data will be handled with~     multiple imputations.~      The trial will start in November 2016 and patient recruitment is expected to finish November~     2017. Analysis and results are expected in 2018.~   "
52688|NCT02877303|"~     The goal of this clinical research study is to learn if Blinacyto (blinatumomab), when given~     after Hyper-CVAD, can help to control newly diagnosed B-Cell Lineage ALL. The safety of this~     drug will also be studied.~   "
52689|NCT02877290|"~     In this study, 20 hypercapnic COPD patients will perform two constant workrate endurance~     cycle tests. One test will be while using non-invasive Ventilation (NIV) support, one without~     in a randomized cross-over design. The aim is to measure, whether NIV is able to change~     peripheral and respiratory muscle oxygenation.~   "
52690|NCT02877277|"~     This study evaluates whether vitamin C improves responses to epigenetic therapy with DNMTis.~     Half of the patients will receive vitamin C and DNMTi while the other half will receive~     placebo and DNMTi.~   "
52691|NCT02877264|"~     This is a randomized, single-center, open-label, three-period, six-sequence, crossover,~     comparative study to evaluate the oral bioavailability of single doses of three vapendavir~     drug product formulations (the 264 mg free base tablet [test drug], 264 mg free base oral~     suspension [test drug], and two 132 mg phosphate salt capsules [reference drug]) in healthy~     volunteers. The study design consists of six dosing sequences. Each sequence comprises 3~     periods and each subject is administered one of the three dosing formulations in the first~     period. A subject receives a different formulation in each of the subsequent periods, so that~     all subjects receive each formulation. The periods are separated by an approximate 7-day~     washout.~   "
52692|NCT02877251|"~     REMMITE, a retrospective and prospective registry with one-year follow-up, will provide~     valuable insights into the clinical diagnosis, management, treatment trends as well as~     related outcomes of three cohorts: DVT, DVT-PE, PE patients throughout many regions of Mexico~     and through different health care systems.~   "
52693|NCT02877238|"~     Remote ischemic preconditioning (RIPC) of the myocardium by limb ischemia/reperfusion may~     mitigate cardiac damage, but its interaction with the anesthetic regimen is unknown.~   "
52694|NCT02877225|"~     The purpose of this study is to demonstrate the bioequivalence (BE) of a new formulation of~     ibrutinib to the marketed Imbruvica formulation in healthy adults under fasted conditions.~   "
52695|NCT02877212|"~     Idiopathic thrombocytopenic purpura (ITP) is an autoimmune disease characterized by~     antibody-mediated platelet destruction. The complex pathogenesis of ITP with multiple~     challenges to immune system in terms of genetic predisposition, infection, responsiveness to~     immunosuppressive therapy (IST) and inhibition of platelet production has proven the~     diversity of constraints in diagnosing and treating ITP. Thrombopoietin receptor agonist~     (Eltrombopag) is specifically indicated for the treatment of thrombocytopenia in patients~     with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient~     response to corticosteroids, immunoglobulins, or splenectomy. This clinical trial aims to~     investigate the association of Fc gammaRIIIA gene (V158F) genetic predisposition with~     treatment outcome of Immune Thrombocytopenia (ITP) in refractory ITP patients and especially~     with Eltrombopag.~   "
52696|NCT02877199|"~     The hypothesis was to check whether baseline anti-E1E2 antibodies were correlated with the~     on-treatment viral kinetics and could predict virological outcome in treatment-experienced~     HCV-infected cirrhotic patients receiving protease inhibitor-based triple therapy.~   "
52700|NCT02877147|"~     The Summer Electronic Benefit for Children (SEBTC) demonstration provided food assistance to~     households with school-aged children during the summer through electronic benefit transfer~     (EBT) procedures used by the Supplemental Nutrition Assistance Program (SNAP) and Special~     Supplemental Nutrition Program for Women, Infants and Children (WIC) programs. The evaluation~     design included two components: an impact study and an implementation study. The evaluation~     assessed the impact of SEBTC on children's food security and nutritional status, household~     food expenditures and purchasing behaviors, parental perceptions, and participation in~     nutrition assistance programs. The implementation study analyzed SEBTC use patterns using~     administrative data, and described demonstration implementation and costs.~   "
52701|NCT02877134|"~     The purpose of the study is to assess the safety and efficacy of JNJ-64304500 in participants~     with moderately to severely active Crohn's disease.~   "
52702|NCT02877121|"~     The purpose of this study is to assess the Respiratory Muscle Function and Neural Respiratory~     Drive in Interstitial Lung Disease patients.~   "
52703|NCT02877108|"~     There is limited information on the best psychoactive medication to treat agitated patients~     in the emergency department. The intent of this study is to fill in knowledge gaps in the~     current practice of treating psychiatric patients in the acute care setting. The purpose of~     this study is to determine the best treatment for agitated psychiatric patients in the~     emergency department.~   "
52704|NCT02877095|"~     The Pilot study is designed to evaluate the overall safety and feasibility of a strategy~     based on subcutaneous delivery of furosemide. It will be used to inform the subsequent~     evaluation phase of the study (separate protocol). The primary objective of the study is to~     determine if a strategy of a novel subcutaneous delivery of furosemide is safe and feasible~     in patients with acute heart failure.~   "
52705|NCT02877082|"~     This phase II trial studies how well tacrolimus, bortezomib, and anti-thymocyte globulin~     (thymoglobulin) work in preventing low toxicity graft versus host disease (GVHD) in patients~     with blood cancer who are undergoing donor stem cell transplant. Tacrolimus and~     anti-thymocyte globulin may reduce the risk of the recipient's body rejecting the transplant~     by suppressing the recipient's immune system. Giving bortezomib after the transplant may help~     prevent GVHD by stopping the donor's cells from attacking the recipient. Giving tacrolimus,~     bortezomib, and anti-thymocyte globulin may be a better way to prevent low toxicity GVHD in~     patients with blood cancer undergoing donor stem cell transplant.~   "
52706|NCT02877069|"~     This study will evaluate the safety and effectiveness of VYC-12 hyaluronic acid (HA)~     injectable gel for filling fine lines, as measured by skin texture improvement, and for~     improvement of skin quality.~   "
52707|NCT02877056|"~     The goal of this laboratory research is to look for genes that can predict which patients~     will achieve a complete disappearance of their colorectal cancer after treatment like~     chemotherapy, radiation, or other therapy.~   "
52708|NCT02877043|"~     In 2009, centres that carried out lung resection for cancer were required to obtain~     authorization following the first cancer plan. One of the criteria to obtain authorization~     was the volume of activity: the centre had to carry out at least 30 lung resections per year~     for cancer. Five years later, it would be useful to know the impact of this new organization~     of oncology on the quality of care. To answer this question, the PMSI database is an ideal~     source of an indicator of quality: in-hospital mortality. This observational cohort study~     will be conducted using the national PMSI database with data covering the period from 1st~     January 2005 to 31st December 2013. It will be limited to hospitalization for lung resection.~     The time will be divided into 3 periods: 2005-2007, 2008-2010 and 2011-2013; the period~     2008-2010 includes the implementation of authorizations for cancer surgery.~   "
52709|NCT02877030|"~     Testing the effectiveness of an exercise protocol engines sensory performed through a virtual~     reality platform in individuals infected with HTLV-1~   "
52710|NCT02877017|"~     Miscommunications are a leading cause of serious medical errors in hospitals, contributing to~     more than 60% of sentinel events, the most serious adverse events reported to the Joint~     Commission. Efforts to improve patient safety in hospitals have centered on improving~     communication between providers. While provider-focused communication interventions have led~     to reductions in patient harm, patients and families have been notably absent from most~     interventions to improve patient safety. This proposal seeks to develop a family safety~     reporting intervention.~   "
52711|NCT02877004|"~     The purpose of this research is to gather preliminary information on the effectiveness of Low~     Level Laser Therapy (LLLT) in helping people reduce their weight gain in the central body~     region.~   "
52712|NCT02876991|"~     The purpose is to evaluate if sodium fluoride PET in patients having already undergone a~     choline PET negative for bone extension (non-metastatic status) modifies the status of~     patients concerning the existence or not of bone metastases.~      Secondary purposes are:~        -  To evaluate if detection of bone metastasis by sodium fluoride PET, not detected by~          choline PET, leads to change of treatment~        -  To evaluate inter-technique concordance (choline vs sodium fluoride PET) of results~          (metastatic status and number of lesions)~        -  To evaluate the inter-judge concordance of interpretation of sodium fluoride PET~        -  To study the discordance of metastatic status of 2 techniques.~   "
52713|NCT02876978|"~     The purpose of this study is to observe and confirm the safety, tolerance and cell~     pharmacokinetics of lentivirus-transduced CAR-GPC3 T cells (CAR-GPC3 T cells targeting GPC3)~   "
52714|NCT02876965|"~     This study evaluates the effect to a muscle stretching program combined with physical~     exercise versus a physical exercise program in patients with fibromyalgia.~   "
52731|NCT02876744|"~     The contribution of OCT- angiography (OCT-A) allows to consider, in a more or less long term,~     a drastic reduction in the use of fluorescein angiographies in diabetic retinopathy. The~     accuracy of the analysis of the vascularization of retinal layers of the posterior pole of~     the eye by the OCT-A , will detect, early and in a quantifiable manner, whether or not there~     are areas of macular ischemia in a patient. However, current technical limitations (small~     field analysis) of OCT-A imaging only allow a limited study of retina at the posterior pole~     of the fundus.~      This study seeks to demonstrate whether there is a link between macular ischemia detected by~     the OCT-A and peripheral retinal ischemia detected by the fluorescein angiographies, in~     diabetic patients.~   "
66716|NCT02693691|"~     The purpose of this study is to characterize the use of the CardioMEMS™ HF System when used~     in a real-world setting.~   "
52715|NCT02876952|"~     Acute myocardial infarction (MI) continues remains to be a major cause of death and~     disability worldwide. Exercise therapy has long been used for rehabilitation purposes and the~     benefit of regular physical exercise is also well established. The intensity of aerobic~     exercise training is a key issue in cardiac rehabilitation programmes.Endurance aerobic~     training is typically performed as continuous training at moderate to-high exercise intensity~     in steady-state conditions of aerobic energetic yield. However, interval training (i.e.,~     repeated bouts of short-duration, high to severe- or severe to extreme-intensity exercise,~     separated by brief periods of lower-intensity) has been proposed to be more effective than~     continuous exercise for improving exercise capacity. Adding to that, health-related~     adaptations to low-volume and high intensity interval training have been presented.~      On the other hand, the Mediterranean Diet has been widely reported to be a model of healthy~     eating for its contribution to a favourable health status and a better quality of life,~     reducing in overall mortality from cardiovascular diseases.~      Considering all the above mentioned in MI population, the principal objective for the~     INTERFARCT study will be to assess the effects of different programs of high intensity~     aerobic interval training and Mediterranean Diet recommendations in the clinical condition,~     cardio-respiratory fitness, biomarkers, ventricular function and perception of quality of~     life after myocardial infarction.~      Methods/Design: One hundred and fifty people after suffering acute MI will perform different~     assessments to evaluate clinical history, physical, biochemical and nutritional condition,~     and quality of life before and after 16-week of follow-up. All participants will receive~     Mediterranean diet recommendations and will be randomly assigned to attention control group~     (diet and physical activity recommendations) or exercise groups (diet recommendations plus~     high-intensity aerobic interval exercise). Participants assigned to an exercise group will~     train 2 days/week under supervision (day 1-treadmill and day 2-bike protocol). There will be~     two aerobic exercise groups: 1) high-intensity interval training and high-volume (HV-HIIT)~     group, and 2) high-intensity interval training and low-volume (LV-HIIT) group.~   "
52716|NCT02876939|"~     This project comprises three sets of physiological studies - testing eight specific~     hypotheses - that will contribute new knowledge on proprioception and motor control in a~     genetic disorder that affects specific components of the sensory nervous system.~      I: To investigate the neurophysiological basis for disturbed motor control in Hereditary~     sensory and autonomic neuropathy (HSAN) III II: To investigate the effects of enhancing~     cutaneous feedback on motor control in HSAN III III: To investigate the cortical~     representation of proprioceptive inputs in HSAN III~   "
52717|NCT02876926|"~     This study explores whether offering follow-up counseling and referral over the phone after~     using a home-based HIV test increases rates of ever and repeat testing, compared with~     home-based testing with no follow-up (HBST alone) or mailing reminders for clinic-based~     testing.~   "
52718|NCT02876913|"~     The nasotracheal intubation is preferred for oral surgery; it provides an easier view of the~     surgical field. However, nasotracheal tubes are produced by foreign countries. Tubes are~     often not fitted in anatomy of Korean people because of small nostril. When the size of the~     tube is chosen by nostril size, the length of nasotracheal tube is not appropriate to the~     glottis. The aim of this study is to evaluate on the proper size of the nasotracheal tube and~     depth in nasotracheal intubation in Korean. Forty patients (20 males and 20 females) who are~     scheduled for nasal intubation for general anesthesia will be enrolled. The primary outcome~     is the proportion of patients who are in inappropriate insertion of nasotracheal tube; the~     proximal end of tube's cuff is less than 2 cm below vocal cord. The size of nostril, length~     from the nare to the carina and vocal cord are measured.~   "
52719|NCT02876900|"~     This study is designed to evaluate efficacy and safety of HP-3070 compared with placebo~     transdermal patch in subjects diagnosed with schizophrenia.~   "
52720|NCT02876887|"~     The COCOA-PAD trial will determine whether epicatechin-rich cocoa daily for six months~     improves walking performance in individuals with peripheral artery disease compared to~     placebo.~   "
52721|NCT02876874|"~     To observe the relationship between the activity of rheumatoid arthritis and~     popliteal/epitrochlear lymph node morphology and the drainage of hand/foot superficial~     lymphatic vessels~   "
52722|NCT02876861|"~     The purpose of this study is to see if getting chemotherapy with Gemcitabine and Cisplatin~     (GC) for 2-4 cycles can help shrink the tumor before undergoing surgery and improves the~     overall survival for high-grade upper tract urothelial carcinoma.~   "
52723|NCT02876848|"~     Background: In women with hormone receptor positive (HR+) breast cancer, adjuvant endocrine~     therapy (AET) is associated with a significant survival advantage. Nonadherence is a~     particular challenge in older women, even though they stand to benefit the most from AET.~     Therefore, a novel e-health tool (OPTIMUM) that integrates real-time analysis of health~     administrative claims data was developed to provide point-of-care decision support for~     clinicians.~   "
52724|NCT02876835|"~     The purpose of this multi-center event-driven study in non-dialysis (ND) participants with~     anemia associated with chronic kidney disease (CKD) is to evaluate the safety and efficacy of~     daprodustat compared to darbepoetin alfa.~   "
52725|NCT02876822|"~     The purpose of this study is to test the efficacy and safety of high dose vitamin D therapy~     among HSCT patients in a tiered, step-wise manner (step one/two) in order to define treatment~     doses capable of providing vitamin D sufficiency.~   "
52726|NCT02876809|"~     This study evaluates the associations between biomarkers of ageing, comprehensive geriatric~     status, telomere length and progerin level, the composition of the gut microbiota, 16sRNA~     metagenome sequencing in Moscow centenarians.~   "
52727|NCT02876796|"~     The primary objective of this study is to assess the pharmacodynamic (PD) effects of GS-0976~     (NDI-010976) on fractional de novo lipogenesis (DNL) following a single oral dose~     administration in overweight and/or obese, but otherwise healthy, male adults.~   "
52728|NCT02876783|"~     Observe and describe the relationships between impairments and function, systematically~     characterize recovery patterns and examine short and long term rehabilitation outcomes. This~     project is purely observational, descriptive and non-experimental. N=273~   "
52729|NCT02876770|"~     The present study aimed to evaluate the possible effect of nocturnal melatonin ingestion upon~     short-term performances, on the following morning. Twelve soccer players from a Tunisian~     squad (22.9 ±1.3 years, 1.80±0.05 m, and 72.0±8.8 kg) were volunteered to perform three~     testing sessions, with one test session per day. During each session, MEL (5mg) , MEL (8mg)~     or placebo were ingested, in a randomized order, before nocturnal sleep. The next morning~     (08:00h), participants performed the following psycho-cognitive and physical tests: Hooper's~     index, reaction time, vigilance, handgrip strength , squat jump , modified agility test ,~     Wingate anaerobic test (peak power , mean power and fatigue index ). Rating of perceived~     exertion was recorded immediately after the WanT, and blood lactate measures were taken after~     3min of recovery. Blood glucose was measured before and 3 min after the Wingate test.~   "
53579|NCT02865655|"~     To apply an existing diagnostic imaging test (saline infusion sonohysterography by~     Hysteroscopic) to characterize the filling defect of a previous cervical cesarean delivery~     scar in the nonpregnant uterus~   "
52732|NCT02876731|"~     Prospective, monocentric, comparative, non randomised~      Primary objective :~      - to compare the diagnostic accuracy of sodium fluoride PET-CT and MRI using the conventional~     block and diffusion sequence in the search for bone metastases~      Secondary objectives :~        -  compare accuracy of MRI diffusion and conventional MRI~        -  explore the evolution of the results of the different types of imaging over time or~          under treatment for patients with repeated examinations at 6 months~   "
52733|NCT02876718|"~     The main objective of the study is to assess preferences of Non Valvular Atrial Fibrillation~     (NVAF) patients towards different options of an anticoagulation treatment.~      Patient preferences for anticoagulant treatment attributes (convenience attributes only),~     based on a Discrete Choice Experiment(DCE) interview will be elicited and the impact of~     switching from Vitamin K Antagonist(VKA) to Xarelto® on Atrial Fibrilation(AF) patient~     treatment satisfaction will be documented, measured by score differences of the Anti-Clot~     Treatment Scale (ACTS) score in patients switching from VKA to Rivaroxaban.~   "
52734|NCT02876705|"~     The purpose of this study will be to study the individual spatiotemporal structure and~     dynamics of topologically defined areas of perceived body discomfort and pain during~     exercise. Participants will perform two constant tests (cycling and running) at an intensity~     corresponding to Borg's scale of Rating of Perceived Exhaustion (RPE) (6-20) = 15 (i.e.,~     hard). Using a body map template, participants will report every 15s the perceived locations~     with discomfort and pain independently of the magnitude of the discomfort and pain.~   "
52735|NCT02876692|"~     This is a prospective cohort study:~        1. First step: to establish a new scoring system for predication of delayed graft~          function(DGF) following kidney transplantation based on previous and new study data. The~          new scoring system is comprised of two parts: Xi'an Criteria of donor scoring system and~          kidney evaluation System based on Lifeport platform ).~        2. Second step: validate the new scoring system through prospective cohort study in our~          transplantation center and modify the scoring system if needed. Recruiting 300 patients,~          follow up at day 3, week 1, month 1, month 3, month 6 and month 12. Patients will be~          followed for Cr30cl, DGF,primary non-function (PNF), acute rejection (AR), graft~          survival and patient survival~        3. Step 3: Further validate the new scoring system in six other transplantation centers and~          developing a software in the end. Recruiting 300 patients, follow up at day 3, week 1,~          month 1, month 3, month 6 and month 12. Patients will be followed for Cr30cl, DGF, PGF,~          AR, graft survival and patient survival~   "
52736|NCT02876679|"~     The study is designed as a two arm randomized Phase II, multicenter trial comparing~     cyclophosphamide to anti-thymocyte globulin for Graft-versus-Host Disease (GVHD) prophylaxis~     in patients with hematologic malignancies undergoing reduced intensity conditioning~     hematopoietic stem cell transplantation.~   "
52737|NCT02876666|"~     The SCI Virtual Coach study has developed an on-screen, human-like character that will~     provide support, education and coaching to adults with spinal cord injury (SCI) to aid in the~     prevention of serious secondary conditions like pressure ulcers. In a randomized controlled~     trial, participants assigned to the Coach intervention will have a touch-screen computer~     placed in their homes and be asked to interact with the Coach on a daily basis for 2 months.~     Participants will be asked to complete surveys at baseline and 2 months.~      The SCI Virtual Coach study aims to measure how accessible and usable participants feel the~     Coach is, as well as participants' adherence to the Coach's instructions. It will also gauge~     how effective the Coach is in changing self-care knowledge, health care behaviors,~     self-efficacy for self-care, and perception of social support in participants.~   "
52738|NCT02876653|"~     Obstructive Sleep Apnea Syndrome (OSAS) regardless of any other associated risk factor can~     lead to accelerated aging. The study of aging-related Obstructive Sleep Apnea (OSA) is~     difficult because of associated risk factors (diabetes, hypertension, dyslipidemia, obesity),~     promoting themselves aging. The investigators propose to compare a group of OSAS patients~     free of any associated pathology, to subjects matched for age, sex, smoking and body mass~     index (BMI)~   "
52739|NCT02876640|"~     This phase 1b trial studies the biologic effect of 9cUAB30 on early stage breast cancer.~     9cUAB30 is a retinoid X receptor (RXR)-selective retinoid that acts in a tissue selective~     manner with the goal of minimizing side effects, a necessary feature of agents under~     development for cancer prevention.~   "
52740|NCT02876627|"~     Introduction: The purpose of this study was to determine the effect of twelve weeks of~     aerobic exercise program on erythrocyte levels in women with breast cancer after~     chemotherapy.~      Methods: Thirty women with breast cancer after chemotherapy of Sydalshhda hospital (aged~     between 47-65 years) volunteered for this study, and then randomly selected an exercise (n =~     15) and control (n = 15) groups. Exercise group completed a twelve-week aerobic exercise~     training program consisted of three sessions per week, each session lasting 30 to 60 minutes~     50 to 75 percent of their maximum heart rate reserve, while the control group were followed.~     Blood samples including red blood cell counts (RBC), hematocrit (HCT), hemoglobin (HB), peak~     oxygen consumption before and after 12 weeks of aerobic exercise were measured. For analysis~     of data, repeated-measures analysis of variance (ANOVA) was used.~   "
52741|NCT02876614|"~     Radionuclide cisternography (RC) is a nuclear medicine examination based on intrathecal~     injection of [111In]diethylenetriaminepentaacetic acid ([111In]DTPA). It is prescribed for~     two recommendations: detection of cerebrospinal fluid (CSF) leak/fistula and diagnosis of~     normal pressure hydrocephalus.~      In the search part of CSF leak/fistula, RC offers the benefit of a 24-hour study of CSF~     unlike other reference tests.~      In addition to SPECT/CT imaging, the radiopharmacist performs sampling in nasal cavities and~     throat of the patient to collect a possible flow of CSF.~      These samples are analysed by radioactivity measurements and bring an added value to the~     exam.~      The interest of this examination for management of CSF leak/fistula remains unclear.~      The aim of this study is to identify and analyse results of all RC examinations performed~     since 2005 in the Nuclear Medicine department of the Neurological Hospital.~      The full analysis of patients will allow discussing the role of RC in management of CSF~     leak/fistulae in clinical practice.~   "
52742|NCT02876601|"~     Defibrotide is an anti-inflammatory and anti-coagulatory agent approved for treatment of~     veno-occlusive disease. Although it has been in clinical use for almost 30 years, the exact~     mechanism of action has never been fully elucidated. Thus, the effects of defibrotide will be~     investigated in the human endotoxemia model in order to gather further information on its~     actions.~   "
52743|NCT02876588|"~     Currently, at least 70,000 U.S. physicians use computerized provider order entry (CPOE) to~     place orders. This number is expected to rise sharply as hospitals continue to take advantage~     of federal incentives and adopt electronic health record (EHR) technology. Although CPOE is~     associated with a reduction in medical errors, when orders are placed electronically certain~     types of errors, including placing orders on the wrong patient, may occur more frequently.~     The mechanism by which multiple patient records opened simultaneously can lead to~     wrong-patient errors may be related to the ease with which users can toggle between patient~     records and the similar looking computer screens. The magnitude of this risk needs to be~     established to help Health Information Technology (IT) leadership decide how to safely~     implement CPOE systems. There have been no studies demonstrating whether multiple records~     increase the risk of wrong-patient errors, by how much, and if any increase is dependent on~     the number of records open. This research project is an important first step in quantifying~     this risk.This will be the first study to achieve the following aims:~        1. Assess the relationship between the number of records open at the time of placing an~          order and the risk of placing an order on the wrong patient.~        2. Compare the incidence of wrong-patient orders in a restricted environment that limits~          providers to only one record open at a time to an unrestricted environment where users~          can open a maximum of four records at once.~        3. Use results to inform a larger-scale health IT implementation research project~          evaluating the balance between the wrong-patient error risks and potential efficiency~          gains of having multiple records open at once, with rigorous research methodologies.~        4. Disseminate results to help inform decisions on how to safely implement EHR systems.~   "
52744|NCT02876575|"~     The purpose of this study is to assess the severity of post-operative pain following the use~     of the BiZact™ device in adult (≥22 years of age in United States and ≥18 years of age in~     Europe) tonsillectomy procedures.~   "
52745|NCT02876562|"~     Recently porcine derived bioresorbable collagen matrices have shown predictable outcomes for~     augmenting keratinzed gingiva , improved wound healing, recession coverage in localized~     gingival recessions and multiple recession coverage.~      However there are very few randomized controlled clinical trials in the literature that~     compare collagen matrix versus connective tissue graft in the management of multiple~     recession type defects. To the best of our knowledge there is only one randomized controlled~     trial that compares modified coronally advanced tunnel+connective tissue graft with collagen~     matrix in the management of multiple gingival recessions.~      Thus aim of this study will be to compare the effectiveness of collagen versus CTG in the~     management of Millers class I and II multiple gingival recessions. The use of collagen matrix~     in combination with Modified Coronally Advanced Tunnel as a surgical technique will be~     compared for recession coverage.~   "
52746|NCT02876549|"~     This will be a single-arm observational cohort study. Malaria patients with Plasmodium vivax~     and meeting study inclusion criteria, who give consent to be enrolled in the study, will have~     their G6PD status measured by the CareStart™ G6DP rapid diagnostic test (G6PD RDT), and~     primaquine prescribed according to the result. According to the G6PD RDT result, primaquine~     will be prescribed at 0.25mg/kg/day for 14 days (normal patients) or 0.75mg/kg weekly for~     eight weeks (deficient patients). All will receive treatment with chloroquine to clear~     asexual stages of infection.~      Patients will be reviewed at day 2, day 7 and day 14. At these visits patients will undergo a~     brief clinical assessment and a small blood sample will be taken for repeat haemoglobin~     measurement and dried blood spot for carboxyprimaquine measurement (day 7 and day 14 only).~      In general, antimalarial treatment will be unsupervised to reflect field conditions. However~     a subset of 25 G6PD normal patients at a single site will have each day of their primaquine~     treatment administered and observed at the treatment centre. This is to determine a~     calibration curve for primaquine pharmacokinetic studies.~      Dried blood spots will be stored appropriately. Day zero samples will be genotyped in Bangkok~     (MORU, Dr. Mallika Imwong) after DNA extraction. PCR-RFLP will be used to detect the allele~     associated with the Mediterranean variant of G6PD deficiency. In addition DNA extracts will~     be sent for more systematic genetic testing for known G6PD variants through existing~     collaborations with the Wellcome Trust Sanger Institute. The day 7 and 14 dried blood spot~     samples will be analysed in the MORU pharmacology laboratory for primaquine and~     carboxyprimaquine concentrations, from which adherence to primaquine can be determined~     retrospectively, using the subset of 25 patients receiving directly observed therapy to~     calibrate the results.~   "
52747|NCT02876536|"~     The aim of this study is to evaluate whether the Transcutaneous Electrical Nerve Stimulation~     (TENS) is effective on improvement of cognitive disorders in Multiple sclerosis patients.~   "
52748|NCT02876523|"~     The management of hilar biliary strictures remains difficult. These strictures are classified~     in 4 types (I,II,III and IV). In palliative cases, an endoscopic drainage should be performed~     in types I and II while a percutaneous drainage is performed in type IV. There is controversy~     as to whether partial or complete liver drainage should be done. Furthermore there are no~     standards for drainage types (metallic stents, plastic stents). Morbidity remains high and a~     multistage procedure can be required.~      This study aims at evaluating the clinical practices in the investigators' center in order to~     determine the key factors that contribute to the drainage success or failure.~   "
52749|NCT02876510|"~     In the IMA101-101 study, patients with relapsed and/or refractory solid cancers will be~     treated with autologous CD8+ T-cell products (IMA101) specific for novel targets from the~     ACTolog warehouse that have been identified by the XPRESIDENT target discovery platform.~      ACTolog is an actively personalized immunotherapy approach in cancer treatment. The ACTolog~     clinical trial IMA101-101 is a first-in-human trial for the ACTolog concept for patients with~     advanced stage solid cancers.~      The goal of this clinical research study is to learn about the safety of giving IMA101 to~     patients with advanced cancer. IMA101 is made with T cells (a type of immune cell) that are~     grown in the laboratory. Researchers also want to learn if IMA101 can help to control the~     disease.~   "
52750|NCT02876497|"~     Surgical samples of human primitive breast: Representative and various surgical samples of~     human primitive breast carcinoma in terms of histological type. Moreover, healthy tissue from~     the same patient will be analysed in parallel. Adjacent normal epithelial structures will be~     defined as at least 5 mm away from the tumor and histologically normal in appearance.~      Isolation, differentiation of human monocyte-derived Macrophages (Mphs) and determination of~     the Macrophage (Mph) migration mode : Human Mphs will be differentiated from blood monocytes~     isolated from the same patient than the tumor sample. Blood samples will be obtained~     following standard ethical procedures.~   "
52751|NCT02876484|"~     The purpose of this study is to examine the effects of bile acid and bile acids sequestrants~     on GLP-1 Secretion, during a meal, in patients after Roux-en-Y gastric bypass.~   "
52776|NCT02876159|"~     This is a prospective pilot study designed to suggest differences in the immunologic response~     to the seasonal influenza vaccine in people with regular vaccination history compared to~     those vaccinated less regularly. Participants will receive one dose of the Food and Drug~     Administration (FDA) approved 2016-2017 seasonal influenza vaccine. Immune system data will~     be collected at standard time points. The duration of the study for each participant will be~     approximately 1 month.~   "
52913|NCT02874365|"~     A monocentric pilot studying intestinal organoids from endoscopic biopsies of IBD (Crohn and~     ulcerative colitis), FAP patients and healthy controls. Investigate the morphological~     characteristics of organoids, the expression of genes and proteins of the~     Wnt/APC/beta-catenin pathway within both ISC.~   "
52752|NCT02876471|"~     Emerging evidence suggests that there is a causal link between obstructive sleep apnea(OSA)~     and hypertension. Patient with this syndrome exhibit several characteristics: high~     prevalence, frequent non-dipper status, diastolic and nocturnal predominance, which are~     related to clinical and subclinical organ damage in heart and brain. However, the influence~     of OSA on nocturnal hypertension development has not yet been clarified. Blood pressure~     variability (BPV) plays a role in vascular damage, independent of blood pressure. Apnea~     overloads the autonomic cardiovascular control system and may influence BPV,which is~     classified by different time interval, including beat-to-beat, hour-to-hour day-to-night~     changes or long-term, for example days, weeks, months, seasons, and even years. All BPV~     abnormalities are associated with an increased incidence of cardiovascular events and~     mortality. The investigators pre-experiment estimate BPV by ambulatory blood pressure~     monitoring (ABPM), which unable to capture the BP fluctuation accurately during the apnea~     event. The small studies exam beat-to-beat BP and OSA，and the investigators can't couple the~     events with blood fluctuation, also incapable calculate the correlation of them. This study~     is aimed to use pulse transmit time(PTT) based blood pressure measurement which can be useful~     for continuous monitoring of blood pressure to monitor nocturnal beat-to-beat blood pressure~     fluctuation in OSA with or without hypertension, investigating the degree of relevance~     between hypoxia, AHI, nocturnal hypertension development and BPV. Besides that the~     investigators also evaluate the effect of continuous positive airway pressure(CPAP) on blood~     pressure and nocturnal beat-to-beat BPV.~   "
52753|NCT02876458|"~     Sudden cardiac death (SCD) remains a major public health issue with a low survival rate. The~     most common cause of SCD is acute coronary artery occlusion. Several registry based studies~     suggest that coronary angiography (CA) performed at admission followed if necessary by~     coronary angioplasty improves in-hospital and long term survival. Recent guidelines recommend~     performing an immediate CA in all survivors of SCD with no obvious non cardiac cause of~     arrest. However there is a lack of randomized data on this topic.~      Several retrospective studies have shown that if the post-resuscitation electrocardiogram~     (ECG) shows ST segment elevation, the probability of finding an acute coronary artery lesion~     during the CA is high (70-80%). In contrast, if no ST segment elevation is present the~     probability is low (15-20%).~      Performing an immediate CA in all survivors of SCD can be challenging. It requires admitting~     these patients to centers with an intensive care unit and facilities allowing 24/24 7/7 CA.~     It may increase the delay of performing other therapeutic modalities such as CT brain or~     thorax scan to determine the cause of SCD. Performing the CA 48 to 96 hours after admission~     would facilitate the management of these difficult patients. However if the cause of the~     arrest is a coronary artery occlusion and there is a delay in reperfusion, the rate of~     post-arrest shock and the mortality may increase. Therefore a randomized study comparing~     immediate versus delayed (between 48 to 96 hours) CA in survivors of SCD with no obvious~     non-cardiac cause of arrest is warranted.~   "
52754|NCT02876445|"~     Huntington's disease (HD) is a rare inherited neurodegenerative disorder, progressing between~     15 and 20 years and affecting one person out of 10.000. In France, it concerns some 6.000~     patients symptomatic and 12 000 asymptomatic carriers.~      Few extensive researches have been conducted on the progression of the disease, which is~     defined in the literature in 5 stages in a functional approach.~      Therapeutically, no cure for HD is currently validated but only symptomatic treatments.~     There's various treatment options: medicated, humans (physiotherapy, speech therapist,~     occupational therapist, ..).~      Although these treatment options do not prevent the progression of the disease, their~     combination associated with a stimulating environment may slow the decline of physical,~     intellectual and psychic abilities of patients.~      In social terms, patients with HD require sustained support, especially in cases of family~     isolation.~      The behavioural, gaiting and eating disorder as well as the communications difficulties make~     it difficult support daily for the entourage. The caregivers are sometimes dealing with~     untenable situations. Home care services, which are crucial to alleviating dependency,~     relieve family caregivers but are for the most severe patient.~      Moreover, the justified placement decision in an institution generates a feeling of guilt for~     the family.~      The caregiver is the person who brings non-professional assistance , partly or wholly , to a~     dependent member of his entourage , for the activities of daily living. This regular care may~     be provided permanently or not. It can take many forms, such as , care , nursing , support to~     education and social life , administrative procedures , psychological support .~      Caregivers have their lives profoundly reshaped. They are often forced to give up some of~     their habits , give up their future plans , change their relationships. The commitment of~     caregivers with patients with Huntington's disease actually sounds on their mental and~     physical health, as well as their social and professional life~      Very few studies have been conducted to measure the difficulties and implications of these~     caregivers.~   "
52755|NCT02876432|"~     Activation of the sympathetic nervous system attenuates inflammation via catecholamines,~     recent advances in electroacupuncture allow activating critical neuronal networks with the~     release of catecholamines the aim of this research was to evaluate de effect of~     electroacupuncture in the activation of sympathetic nervous system and the control of low~     back pain in athletes~   "
52756|NCT02876419|"~     The REP 301 treatment protocol involved the treatment of patients with chronic hepatitis B /~     hepatitis D co-infection with two agents: REP 2139-Ca and pegylated interferon (peg-IFN). In~     this protocol, similar reduction/clearance of serum HBsAg and improved response to~     immunotherapy were observed in addition to clearance of serum HDV RNA. The REP 301 protocol~     was designed to include a 24 week follow-up period after treatment, however given the strong~     antiviral response against HBV and HDV infection in these patients, it is now important to~     extend the follow-up period in these patients to monitor over a longer period after treatment~     the safety and efficacy combined REP 2139-Ca / peg-IFN treatment in patients in the REP 301~     protocol.~   "
52757|NCT02876406|"~     This study evaluates the usefulness of the ΔvapCO2 / Cav02 ratio to predict complications~     after elective cardiac surgery, comparing it with others markers such as lactate,~     arteriovenous CO2 difference (ΔvapCO2) and would try to developed a new predictive score for~     postoperative complications.~   "
52777|NCT02876146|"~     Study design to define improved management of patients with hepatic alveolar echinococcosis~     treated with albendazole and especially make appropriate and timely decision of treatment~     withdrawal .~      Based on exploratory analysis of existing and newly developed biological and imaging exams,~     for diagnosis and follow-up, and study of the relationship of these markers to the viability~     of the parasite and/or the activity of the parasitic lesions The study included two series of~     patients: operated on (curative hepatectomy) // non-operated on~   "
52978|NCT02873520|"~     To evaluate the safety and effectiveness of cell therapy using Precision Cells to treat~     Advanced Gastric Cancer.~      Eligibility:~      Individuals greater than or equal to 18 years of age and less than or equal to 65 years of~     age who have been diagnosed with Advanced Gastric Cancer.~   "
52758|NCT02876393|"~     Diabetic retinopathy(DR) is a sight threatening condition that occurs in persons with~     diabetes. DR arises as a consequence of damage to the retinal blood vessels and is related to~     the high and fluctuating sugar levels in the blood stream. An eye with DR will have abnormal~     appearing retinal blood vessels which become engorged and dilated, leaky and fragile or~     undergo closure. The net result is a picture of haemorrhage and or ischaemia (lack of blood~     supply). A particular feature of DR is the accumulation of fluid in the macula which is the~     central part of the retina and responsible for detailed eye sight. This peculiar form of DR~     is called Diabetic Macular Oedema (DMO). DMO can occur in isolation without other features of~     DR. DMO is commoner in type 2 diabetes where insulin resistance and abnormalities of blood~     fats are found. The investigators wish to study DR and DMO using high resolution retinal~     imaging and functional tests in normal participants, those participants with diabetes without~     any overt signs of disease and those with DR and DMO in order to understand how the condition~     develops and whether there are any unique risk factors that can be identified~   "
52759|NCT02876380|"~     The postnatal diagnosis of Long QT Syndrome (LQTS) is suggested by a prolonged QT interval on~     12 lead electrocardiogram (ECG), strengthened by a positive family history and/or~     characteristic arrhythmias and confirmed by genetic testing. However, for several reasons~     such LQTS testing cannot be performed successfully before birth. First, fetal ECG is not~     possible and direct measure of the fetal QT interval by magnetocardiography is limited to~     fewer than 10 sites world-wide. Second, while genetic testing can be performed in utero,~     there is risk to the pregnancy and the fetus. Third, although some fetuses present with~     arrhythmias easily recognized as LQTS (torsade des pointes (TdP) and/or 2° atrioventricular~     (AV) block, this is uncommon, occurring in <25% of fetal LQTS cases. Rather, the most common~     presentation of fetal LQTS is sinus bradycardia, a subtle rhythm disturbance that often is~     unappreciated to be abnormal. Consequently, the majority of LQTS cases are unsuspected and~     undiagnosed during fetal life, with dire consequences. For example, maternal medications~     commonly used during pregnancy can prolong the fetal QT interval and may provoke lethal fetal~     ventricular arrhythmias. But the most significant consequence is the missed opportunity for~     primary prevention of life threatening ventricular arrhythmias after birth because the infant~     is not suspected to have LQTS before birth. The over-arching goal of the study is to overcome~     the barriers to prenatal detection of LQTS. The investigators plan to do so by developing an~     algorithm using fetal heart rate (FHR) which will discriminate fetuses with or without LQTS.~      Immediate Goal: The investigators propose a multicenter pre-birth observational cohort study~     to develop a Fetal Heart Rate (FHR)/Gestational Age (GA) algorithm from a cohort of fetuses~     recruited from 13 national and international centers where one parent is known by prior~     genetic testing to have a mutation in one of the common LQTS genes: potassium voltage-gated~     channel subfamily Q member 1 (KCNQ1), potassium voltage-gated channel subfamily H member 2~     (KCNH2), or sodium voltage-gated channel alpha subunit 5 (SCN5A). The investigators have~     chosen this population because 1) These mutations are the most common genetic causes of LQTS,~     and 2) Offspring will have high risk of LQTS as inheritance of these LQTS gene mutations is~     autosomal dominant. Thus, progeny of parents with a known mutation are at high (50%) risk of~     having the same parental LQTS mutation. The algorithm will be developed using FHR measured~     serially throughout pregnancy. All offspring will undergo postnatal genetic testing for the~     parental mutation as the gold standard for diagnosing the presence or absence of LQTS.~   "
52760|NCT02876367|"~     This study to collect and identify rodents and mites across transects through diverse~     habitats used by the human community from a localised area identified as a scrub typhus 'hot~     spot'.~   "
52761|NCT02876354|"~     Vitamin K2 deficiency has been shown to be profound in hemodialysis patients. It is reflected~     by high plasma levels of dephosphorylated-undercarboxylated Matrix Gla protein (dp-ucMGP) and~     seems to be correlated with vascular calcifications. Vascular calcifications can be assessed~     using the AC24 score on a lateral abdominal X-ray.~      The aim of this study is to assess first the rate of decrease of dp-ucMGP in a hemodialysis~     cohort after supplementation with vitamin K2 and the correlation between this rate of~     decrease and the Aortic Calcification Severity (AC24) score. The factors associated with high~     levels of dp-ucMGP will be analyzed as well.~   "
52762|NCT02876341|"~     Retrospective two-cohort study to determine the effect of chronic antihypertensive therapy on~     new onset atrial fibrillation and clinical outcomes in septic shock.~   "
52763|NCT02876328|"~     The purpose of this study is to evaluate the safety and immunogenicity of three vaccine~     strategies that may prevent Ebola virus disease (EVD) events in children and adults.~     Participants will receive either the Ad26.ZEBOV (rHAd26) vaccine with a MVA-BN-Filo (MVA)~     boost, or the rVSVΔG-ZEBOV-GP (rVSV) vaccine with or without boosting, or placebo.~   "
52764|NCT02876315|"~     Many older adults do not get enough zinc, vitamin C and vitamin D, and this can be related to~     decreased ability to fight infection. The purpose of this research study is to determine if~     taking a multivitamin/mineral supplement every day for 12 weeks will increase the ability of~     immune cells in blood to kill bacteria.~   "
52765|NCT02876302|"~     This research study is studying Ruxolitinib as possible treatment for Inflammatory Breast~     Cancer (IBC).~      The Following drugs will be use in combination with Ruxolinitinib.~        -  Paclitaxel (also called Taxol)~        -  Doxorubicin also called Adriamycin~        -  Cyclophosphamide, also called Cytoxan~   "
52766|NCT02876289|"~     Perampanel is a non-competitive antagonist of the AMPA (~     2-amino-3-(5-méthyl-3-hydroxy-1,2-oxazol-4-yl)) propanoïc acid receptors which was approved~     by the European Medicines Agency as adjunctive treatment for partial-onset seizures in~     patients 12 years and older, in 2012. The aim of this study is to evaluate effectiveness and~     safety of perampanel as add-on treatment in patients with refractory epilepsy.~      The investigators retrospectively collected and analyzed the data of patients with refractory~     epilepsy who had been treated with perampanel between May of 2014 and April of 2015. In~     total, one hundred and ten patients were included (mean age 41 [SD = 15.2]). The mean~     duration of epilepsy was 25 years (SD = 14.4). The mean perampanel dose was 5.7 mg/d (SD =~     2.3). The retention rate was 77% at 6 months and 61% at 12 months. After 6 months, the~     responder rate was 35.5%. Eight patients (7.3%) became seizure free. Adverse effects were~     reported in 60 patients (54.5%). Most common side effects were behaviour disturbance (22.7%),~     dizziness (15.5%), asthenia (11.8), somnolence (10%) and ataxia (9.1).~   "
52767|NCT02876276|"~     Hyaluronic acid (HA) has been used as a dermal filler in medicine for many years. It also has~     umpteen benefits in terms of aiding in rapid healing and resolution of inflammation. Thus in~     the present study, HA has been used at the test site to fill papillary recession defects. At~     the control site saline was injected as the placebo.~   "
52768|NCT02876263|"~     The aim of this prospective, explorative study of noninvasive neuromonitoring was to search~     potential and practical methods associated with neurological outcome in the perioperative and~     immediate postoperative setting of surgery of the thoracic aorta. These methods include~     abbreviated EEG monitoring, near-infrared spectroscopy, transcranial Doppler ultrasound and~     biochemical markers associated with neuronal damage.~   "
52818|NCT02875600|"~     To determine the difference in baseline MR flow measurements and post-prandial MR flow~     measurements between patients diagnosed with CGI and patients not diagnosed with CGI.~   "
52769|NCT02876250|"~     The morbidity and mortality of patients undergoing lung transplantation in the acute phase~     following surgical intervention is mainly due to the primary graft failure (PGF).~      The occurrence of PGF is multi factorial but is mainly caused by ischemia-reperfusion injury.~     The pulmonary graft suffers two periods of ischemia one when it is explanted from the donor~     (cold ischemia) followed by another when it is grafted into the recipient's thoracic cavity~     (warm ischemia). The brutal reperfusion of the graft exposes it to reperfusion injury that~     causes PGF. PGF occurs in up to 20% of transplanted patients and is associated with~     significantly higher levels of 30-days all-cause mortality. Patients with PGF have a 40%~     mortality at 30-days versus a 6% mortality in patients without PGF.~      Ischemic postconditioning, has recently been described in experimental models of~     ischemia-reperfusion injury in the heart, and although not yet fully understood. Several~     studies suggest that the mitochondria play a central role in cellular survival mechanisms~     after a prolonged period of ischemia-reperfusion (with the mitochondrial permeability~     transition pore (mPTP)).~      Experimental studies have shown that cyclosporin A (CsA) administered prior to reperfusion~     binds to cyclophilin D and blocks the opening of mPTP after reperfusion. This protective~     effect of ischemia-reperfusion injury by CsA has been shown in experimental studies and in~     clinical phase II trials in reperfused myocardial infarction patients.~      The hypothesis of this study is that the administration of CsA in transplanted patients~     (before re-opening of the first pulmonary graft vessels) protects the transplanted lung(s)~     from the deleterious effects of ischemia-reperfusion injury and thus reduce the frequency and~     severity of PGF.~   "
52770|NCT02876237|"~     The investigators propose to carry out a prospective analysis of physical impact,~     psychological, cognitive and social of radiotherapy in all patients over 75 years bearer of~     localized prostate cancer with an indication of curative radiotherapy. This standardized~     geriatric assessment will collect social information, functional, sensory, cognitive,~     emotional, motor, nutritional, and medical related to comorbidities . The quality of life of~     patients will be evaluated by the QLQ C30 (Quality of Life Questionnaire) European~     Organisation for Research and Treatment of Cancer (EORTC) before starting treatment, at the~     end of radiotherapy (2 months) and at 6 months. This short follow-up period seems appropriate~     in this elderly population and will allow an answer within 2 years to the problem raised in~     clinical practice.~   "
52771|NCT02876224|"~     This is an open-label, multicenter, single-arm, two-stage, Phase Ib study designed to assess~     the safety, tolerability, and pharmacokinetics of oral cobimetinib with intravenous (IV)~     atezolizumab and bevacizumab in participants with metastatic colorectal cancer (mCRC) who~     have received and progressed on at least one prior line of therapy that contained a~     fluoropyrimidine and oxaliplatin or irinotecan. There are two stages in this study: Stage 1~     (safety run-in phase) and Stage 2 (dose expansion phase with two cohorts, an expansion cohort~     and a biopsy cohort).~   "
52772|NCT02876211|"~     Anemia of inflammation (AI) is a common comorbidity in hemodialysis patients. Paricalcitol is~     a selective vitamin D receptor activator with potential benefits on anti-inflammatory~     cytokines expression. The paricalcitol for the secondary hyperparathyroidism control may~     improve AI decreasing erythropoietin stimulating agents (ESAs) dosage.~   "
52773|NCT02876198|"~     The intra-vitreous injection (IVT) of anti-VEGF (vascular endothelial growth factor) is~     currently the standard treatment for retinal neovascularization. The VEGF stimulates~     endothelial cells' proliferation and migration. It also increases microvascular permeability.~     If the VEGFs have proven their efficiency in the decrease of choroidal neovascular~     proliferation, their impact of the head of the optic nerve's microvasculature is yet unknown.~     Knowing that this microvasculature provides the retinal nerve fibers with oxygen, located in~     the area of the head of the optic nerve, a vasoconstriction induced by the anti-VEGF may have~     an incidence on the loss of retinal nerve fibers.~   "
52774|NCT02876185|"~     Glaucoma is a progressive optical neuropathy, generally associated with ocular hypertension.~     The treatment aims to stabilize the visual field deficiencies by lowering the intraocular~     pressure. Due to the fluctuation of the visual field test and re-test measures, the European~     recommendations are to obtain 6 visual field tests in 2 years (or one every 4 months) in~     order to know if the pathology is progressing despite the current treatment (or if the~     treatment is necessary, in cases of intraocular hypertensions). The lack of ophthalmologists~     renders the monitoring of a beginning glaucoma, rarely compatible with the present~     recommendations. It is therefore crucial to evaluate new therapeutic alternatives, when faced~     to a decreasing medical demography and an increase the patient's needs.~      This study should allow to validate the possibility to delegate monitoring tasks to~     orthoptists during glaucoma surveillance. To organize the delegation of this surveillance to~     orthoptists would permit a better distribution of the ophthalmologist's activities.~   "
52775|NCT02876172|"~     This small study will look at the safety and estimate the strength of effect (effect size) of~     a combination of Cognitive Behavioral Conjoint Therapy (CBCT) and~     3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in ten pairs of people, one~     with and one without PTSD. The pairs can be spouses or romantic partners, siblings or other~     relatives or close friends. The study will measure PTSD symptoms, as well as symptoms of~     depression, sleep quality and relationship satisfaction and functioning before and after a~     one-month course of CBCT that includes two MDMA+CBCT visits. CBCT psychotherapy is designed~     to treat PTSD and relationship problems in pairs in a close relationship, and MDMA-assisted~     psychotherapy uses the experimental drug MDMA to enhance and strengthen psychotherapy. There~     is evidence that each of these treatments, on its own, can help people with PTSD. The study~     will also measure personality and how each member of a pair thinks about and behaves in~     relationships and expresses emotions before and after having MDMA+CBCT. Pairs will have two~     day-long sessions scheduled two weeks apart. During the first MDMA+CBCT session, both members~     of the pair will receive 75 mg MDMA with the option of receiving a second dose of 37.5~     approximately an hour and a half later. During the second session of MDMA+CBCT, subjects may~     receive either 100 or 75 mg, with the decision concerning dose made by the researchers after~     discussion with the subjects. An optional dose half the size of the initial dose will be~     offered approximately an hour and a half later. Following informed consent and screening~     there will be one enrollment visit over videoconference. Before the first MDMA+CBCT session,~     there will be an introductory session including 3 segments of CBCT psychotherapy on the day~     before the first MDMA session. The introductory session and the CBCT sessions will be done in~     person at the study site. During each MDMA+CBCT sessions, two therapists will work with with~     the pair. Blood pressure, heart rate and body temperature will be measured periodically~     during each MDMA+CBCT session. The pair will stay at the study site overnight with a night~     attendant on duty, and they will have an integrative psychotherapy session on the morning~     after the MDMA+CBCT session. Each member of the pair will be contacted by the researchers for~     a week after each MDMA+CBCT session. The pair will have CBCT and integrative sessions over~     videoconferencing twice a week for two weeks following the on-site integrative session. One~     month after the second MDMA+CBCT session, both participants will have an evaluation and~     testing visit over videoconference and will complete measures of PTSD symptoms, sleep~     quality, perceived growth related to experiencing a trauma, symptoms of depression, and how~     people think and feel about emotions and their relationships. The member of the pair with~     PTSD will also undergo an interview measure of PTSD symptoms. The pair will complete measures~     and questionnaires three and six months after the second MDMA+CBCT session. The study is open~     label, meaning the researchers and subjects will be aware of the doses of MDMA used in the~     study. The study will test and compare changes in symptoms and relationship issues before and~     after the course of psychotherapy.~   "
54831|NCT02849275|"~     This research intervention aims to examine the effects of a fermented dairy beverage~     consumption on changes in behavioral and biological measures of cognition and stress among~     obese adults.~   "
52778|NCT02876133|"~     Colorectal cancer (CRC) is a leading cause of cancer death and its' incidence is rising in~     most European countries. Colonoscopy has been shown to reduce CRC incidence, however its~     effectiveness depends on the sensitivity to detect pre-malignant lesions.~      Our aim is to evaluate narrow band imaging (NBI) during colonoscopy and serum miRNAs as novel~     tools for the early detection of colonic sessile serrated lesions (SSL). The investigators~     will perform a multicenter-randomized-controlled-trial to study the role of NBI in SSL~     detection.~   "
52779|NCT02876120|"~     The START study will implement osteoarthritis (OA) treatment recommendations to increase the~     use of recommended treatment modalities and reduce non-desired events (e.g. unnecessary~     referrals to secondary care, unnecessary use of costly imaging modalities and use of~     treatment modalities supported by low quality of evidence). The purpose of the STavanger~     osteoARThritis (START) study is to improve the quality of OA care and increase the~     collaboration between health care professionals in primary health care and across health care~     levels.~   "
52780|NCT02876107|"~     The goal of this clinical research study is to learn if adding panitumumab to the combination~     of carboplatin and paclitaxel can help to control IBC when given before other standard~     chemotherapy and surgery. The safety of these drug combinations will also be studied.~      This is an investigational study. Panitumumab is FDA approved and commercially available for~     the treatment of EGFR-expressing metastatic colorectal cancer with disease progression.~     Paclitaxel, carboplatin, doxorubicin and cyclophosphamide are FDA approved and commercially~     available for the treatment of breast cancer. The addition of panitumumab to the combination~     of carboplatin and paclitaxel is investigational and currently being used for research~     purposes only. The study doctor can describe how the study drugs are designed to work.~      Up to 72 participants will be enrolled in this study. All will take part at MD Anderson.~   "
52781|NCT02876094|"~     Several factors make the use of celecoxib in human SMA patients appealing including: 1)~     low-dosing required for potential therapeutic effect (the corresponding dose in humans is~     much lower than that commonly used in adults and children with; 2) favourable side effect~     profile of this drug (particularly at the dosing required); 3) the fact that celecoxib~     crosses the blood brain barrier and 4) demonstration of efficacy in a genetically and~     pathophysiologically faithful animal mode. The investigators therefore believe that celecoxib~     is a promising disease modifying therapy for SMA.~   "
52782|NCT02876081|"~     Lung cancer is the leading cause of cancer deaths in France, Europe and the world. 50% of~     lung cancers are of the adenocarcinoma subtype. 60% of patients present with a metastatic~     disease (stage IV) at the time of diagnosis. Approximately 10% of patients present with a~     mutation of the epidermal growth factor receptor (EGFR) requiring an EGFR tyrosine kinase~     inhibitor (EGFR-TKI), namely erlotinib, gefitinib or afatinib. For the majority of~     chemotherapy-naïve patients without addictive mutation, platinum-based chemotherapy,~     frequently the platinum - pemetrexed doublet, provides disease control rate of up to 70% and~     improves survival from approximately 4.5 with best supportive care alone to 15 months.~     However, patients with non-small cell lung cancer (NSCLC) usually relapse within 4 to 6~     months and benefit from a second-line chemotherapy. Authorized drugs in this setting are~     pemetrexed, docetaxel and erlotinib. The prescription of erlotinib for unselected patients~     whose tumor does not harbor an EGFR mutation is questionable . In the second line setting,~     docetaxel provides less than 10% of partial responses and progression-free survival of 10 to~     12 weeks. There are no standard options following failure of two previous lines of standard~     chemotherapy. In view of these modest results, new agents and therapeutic strategies are~     greatly needed for this patient population.~      Neurotensin (NTS) is a 13 amino acids peptide, present and biologically active in the central~     nervous system and in periphery. At the peripheral level, NTS is released by the endocrine~     cells of the intestinal mucosa after meals and acts as an endocrine hormone involved in the~     postprandial regulation of the motor functions of the gastrointestinal tract. The effects of~     NTS are mediated by three subtypes of receptor: NTSR1 and NTSR2 exhibit high and low affinity~     for NTS, respectively, and belong to the family of G protein receptors; NTSR3 is a single~     transmembrane domain receptor. Exogenous activation of NTSR1 leads to cell proliferation,~     survival, mobility and invasion in cancer cells from diverse origin. These effects are the~     result from the activation of kinases and effectors, such as PKC, MAPK, FAK, RHO-GTPase, RAS~     and Src. The PKC activation may induce MAPK by direct stimulation of Raf-1, or by~     transactivation of the EGFR. The activation of MAPK via NTSR1 is mainly associated with~     uncontrolled cell growth. Both NTS and NTSR1 are expressed in 40% of lung tumors, whereas~     they are never expressed in the normal tissue. NTSR1 high expression is a negative prognostic~     factor in stage I to III operated lung adenocarcinomas. Sustained stimulation of NTSR1~     results in the activation of MMP1, the release of EGF like ligands such as HB-EGF as well~     as neuregulin 1 NGR1 (a specific ligand for HER3) followed by EGFR, HER2 and HER3~     overexpression and activation. Accordingly, xenografted tumors expressing NTS and NTSR1 show~     a positive response to erlotinib, whereas tumors void of NTSR1 expression have no detectable~     response.~      Afatinib (BIBW2992) is a small molecule, selective and irreversible erbB family blocker. In~     preclinical models it effectively inhibits EGFR, HER2 and HER4 phosphorylation resulting in~     tumour growth inhibition and regression of established subcutaneous tumours derived from four~     human cell-lines known to co-express ErbB receptors.~      Our claim is that patients harbouring the NTS/NTSR complex, without EGFR mutation, will~     respond to afatinib due to the sustained activation of EGFR/HER2 under neurotensin~     activation.~      Presently, only EGFR mutated tumors are eligible to receive EGFR TKI representing 10% of all~     lung cancer patients. The aim of this study is to evaluate the efficacy of afatinib, an EGFR~     TKI, on lung adenocarcinomas, EGFR wild-type, bearing the NTS/NTSR1 complex with a high level~     of expression. This subpopulation of patients represents approximately 20% of lung~     adenocarcinomas.~   "
52783|NCT02876055|"~     Total shoulder arthroplasty (TSA) is considered to be a major surgical procedure resulting in~     severe postoperative pain, especially in the first 48 hours after surgery. The use of~     interscalene brachial plexus nerve block remains the cornerstone for analgesia following~     shoulder surgery; however, with the advent of local infiltration analgesia (LIA), there has~     been increasing interest in its use for total joint arthroplasty.~      Since the benefits of local infiltration analgesia within a comprehensive multi-modal~     analgesia clinical pathway have yet to be established for total shoulder arthroplasty, the~     Investigators plan to assess and compare analgesia outcomes between three intervention~     groups: single shot interscalene brachial plexus block (SISB), continuous interscalene~     brachial plexus block (CISB), and local infiltration analgesia (LIA).~   "
52784|NCT02876042|"~     The purpose of this registry is to evaluate the effect of BAROSTIM THERAPY with the BAROSTIM~     NEO system in the commercial setting in subjects recently implanted under the CE-Marked~     indication for resistant hypertension that also have evidence of heart failure with preserved~     ejection fraction (HFpEF).~   "
52785|NCT02876029|"~     The study focus is on the possible improvement in glucose tolerance at a second standardized~     meal that can be achieved when preceded by a test meal with a low GI and a high GP.~   "
52786|NCT02876016|"~     Bring elements of understanding to the study of brain organization bodily representations.~     The body is organized into multiple, distinct levels of representation. The body schema is an~     unconscious and dynamic representation of his body, updated constantly, resulting from the~     convergence of multiple sensory information, which articulates with the motor systems to~     participate in the genesis of the action. The self-image corresponds to a more abstract~     representation of the body, covering symbolic and imaginary aspects drawn from the emotional~     life of the individual. Finally, the body of another person engages simultaneously shared and~     differential representational systems that allow understanding the actions of others while~     preserving the identity of the agent responsible for the action. These various bodies~     represented subtly interacting and participating in equilibrium, the self-awareness building~     as being curious, social and acting. Brain organization bodily representations remains a~     fundamental question still poorly explored that is of major scientific interest because of~     its influence on identity and social construction, and the serious repercussions that are~     their problems, also for the individual and society. This project aims to deepen this~     hypothesis using a methodology combining functional imaging and awake surgery. The richness~     of this project lies in the innovative methods of investigation, and in the plurality of~     disciplines (neuropsychology, neurophysiology, neuroimaging and neurosurgery) and teams~     (clinical and research) grouped for wear.~      The subjects enrolled in this study are all candidates in patients with awakened provided~     surgery for therapeutic reasons, and volunteer to participate in this experiment. Awake~     neurosurgery is for patients with glial tumors, but also brain metastases and~     intra-parenchymal cavernomas. A first experimental session will be held in pre-operative~     period. Patients realize a functional magnetic resonance imaging (fMRI) brain to define a~     precise functional mapping of cortical structures, including lateral occipital, involved in~     body representation. The second experimental session will be conducted in the neurosurgical~     intervention, practiced one to four weeks later.~      This dual approach that combines the functional stimulation of a cortical area (imaging) and~     functional inhibition (in surgery) allows you to make extremely robust scientific arguments~     about the causal relationships linking structure and function~   "
52787|NCT02876003|"~     Glioblastoma (GBM) comprises about 16% of all malignancies of the nervous system and over 50%~     of all gliomas. Standard of care for newly-diagnosed GBM is a combination of surgical~     debulking followed by concurrent radiotherapy and chemotherapy with temozolomide. Efforts to~     improve second-line therapy in GBM have met with only marginal success and there is a large~     unmet medical need for new therapies. G-202 (mipsagargin) is an example of prodrug~     chemotherapy. It is activated by Prostate Specific Membrane Antigen (PSMA), which is~     expressed by some cancer cells and in the blood vessels of most solid tumors, including GBM,~     but not by normal cells or blood vessels in normal tissue. It is believed that activation of~     the prodrug G-202 will allow the drug to kill cancer cells. This study will evaluate the~     activity, safety and CNS exposure of G-202 in patients with PSMA-positive recurrent or~     progressive GMB receiving G-202 by intravenous infusion on three consecutive days of a 28-day~     cycle.~   "
52819|NCT02875587|"~     The aim of this study is to compare the efficacy of calcium gluconate infusion versus~     cabergoline in the prevention of ovarian hyperstimulation syndrome (OHSS) in patients~     pretreated with GnRH agonist long protocol who are at high risk for OHSS.~   "
52979|NCT02873507|"~     A pilot prospective cohort study assessing the clinical utility of MRI evaluation of graft~     steatosis prior to transplantation will be conducted. An MRI of the donor liver within the~     transport cooler will be obtained on its way to the operating room.~   "
52788|NCT02875990|"~     Infection with Human Papillomavirus high-risk Human (HR-HPV) is the main factor of risk of~     cancer of the cervix. Recent studies show that cancers linked to infection with HR-HPV are~     associated with immunosuppression and lack of T cell response Such mechanisms would promote~     progression to cancer and progression of it . Various factors such as an increase of~     regulatory T cells, the presence of myeloid cells and suppressor of defects in the signaling~     pathway Toll Like Receptor (TLR) may have a key role in these immunosuppression mechanisms.~     At this stage of knowledge, a better characterization of local and systemic immunosuppressive~     signing of cervical cancer is needed. The results should have a significant medical impact~     for the identification of new prognostic markers and new therapeutic targets for the~     treatment of patients with cervical cancer.~      The aim of this research project is to define the signing of immunosuppressive cancer cervix~     and analyze the different mechanisms involved in this immunosuppression.~   "
52789|NCT02875977|"~     The investigators intend to measure compliance with attending pelvic floor physical therapy~     (PFPT) in a Urogynecology population by randomizing patients to either viewing a four minute~     educational video or reading a handout explaining the therapy.~   "
52790|NCT02875964|"~     Presurgical evaluation of epileptic patients require a precise mapping of cerebral regions~     implied in epileptic discharges and in normal function.~      The current practice in most cases is to implant intracerebral electrodes in order to~     localize these regions in a reliable manner. However, non-invasive methods have been~     developed in order to record brain activity with no risk for the patient.~      Still, it is necessary to validate and improve the signal processing methods and the~     underlying models these methods in order to optimize their use in clinical practice. To do~     so, it is necessary to record simultaneously electroencephalogram (EEG) and~     magnetoencephalogram (MEG) and stereo encephalogram SEEG (intracerebral). Such simultaneous~     recordings will permit to confront the exact same activity recorded non-invasively at the~     surface of the head, and represented on the brain thanks to the model and directly within the~     brain.~      The objective is to define the conditions under which one can represent faithfully the~     activity measured intracerebrally from the surface measurements.~      It will be record simultaneously MEG, scalp EEG and intracerebral EEG on a series of 60~     patients. It will be record resting state signals, as well as stimulation protocols. The~     interictal epileptic discharges will be marked on the different modalities, and evoked~     potentials/fields computed in response to protocols. Sensitivity of recordings to activity~     visible on depth recordings will be evaluated as a function of localization of brain~     generators. Advanced signal processing methods will be used such as source localization and~     independent component analysis, in order to increase sensitivity of measures.~   "
52791|NCT02875951|"~     A prospective, non-interventional, non-controlled multicenter observational study to evaluate~     aspects of pharmaceutical care and the treatment of postmenopausal patients with~     hormone-receptor positive, HER2-receptor negative, advanced breast cancer treated with~     everolimus and exemestane.~      The main objective of the study is to evaluate medication adherence in postmenopausal,~     hormone-receptor positive, HER2-receptor negative, advanced breast cancer treated with a~     combination of everolimus and exemestane. Additionally, other aspects of the pharmacotherapy,~     with focus on the patient perspective, will be investigated:~        -  Patient satisfaction with treatment information~        -  Patient satisfaction with treatment~        -  Health-related quality of life~        -  Treatment efficacy~        -  Treatment-related toxicity~        -  Patient follow-up by the oncologic team/general practitioner and or specialized home~          nurses~      This study should reveal information necessary for the development of pharmacotherapeutic~     care concepts that meet the needs of cancer patients treated with an oral anti-cancer drug~     over a long period.~   "
52792|NCT02875938|"~     This investigation uses a single-subject, adapted alternating research design to compare two~     different experimental conditions using music with lyrics combined with visual stimulation of~     the written lyrics, to extend the emotional word effect to phrases, in order to stimulate~     reading comprehension of the trained material for patients with aphasia. The two music~     conditions include 1) music with sung lyrics simultaneously with silent reading of the~     written lyrics; and 2) music with sung lyrics, followed by silent reading of the written~     lyrics (i.e. priming with the music). A control set without music will be used additionally~     within every third session to detect potential history and maturation effects. All conditions~     will be followed by a silent reading phrase-completion task composed of written words from~     the total combined sets of stimuli.~   "
52793|NCT02875925|"~     This is a non-randomized, prospective, quasi-experimental study designed to assess the impact~     of pharmacist-provided medication management on total cost of care and clinical outcomes (ie,~     hospitalizations, emergency department visits) in a real-world clinical practice.~   "
52794|NCT02875912|"~     This study will evaluate whether or not engaging family members of patients admitted to the~     ICU in Family Care Rituals will reduce stress related symptoms of PTSD, depression and~     anxiety 90 days after patient death or discharge from the ICU. Family Care Rituals are~     defined as several domains in which family participation may be of benefit, focusing on the 5~     physical senses as well as the personal care of the patient and spirituality of the patient~   "
52795|NCT02875899|"~     Prospective, single-arm, multicentre, international Registry of the Surfacer System for the~     treatment of patients with limited or diminishing upper body venous access or pathology~     impeding standard access methods.The purpose of this post-market Registry is to assess the~     standard of care and clinical outcomes of the Surfacer System used in clinical routine~     according to the approved commercial indications.~   "
52796|NCT02875886|"~     In this clinical study the anti-hypertensive response to dietary salt restriction is compared~     with the anti-hypertensive response to the diuretics hydrochlorothiazide/amiloride in adult~     patients with chronic kidney disease.~   "
52797|NCT02875873|"~     A 2x2 factorial randomized study to evaluate the effect of a balanced crystalloid solution~     compared with 0.9% saline, and of rapid vs. slow infusion on clinical outcomes of critically~     ill patients~   "
52798|NCT02875860|"~     This trial will test whether temporary fetoscopic endoluminal tracheal occlusion (FETO)~     rather than expectant management during pregnancy, followed by standardized postnatal~     management, increases survival at discharge and decreases oxygen need at 6 months in case of~     survival till discharge.~   "
54832|NCT02849262|"~     The purpose of this study is to assess the pharmacodynamics, safety and efficacy of omiganan~     in patients with external genital warts.~   "
52799|NCT02875847|"~     The study is a randomised, placebo-controlled, double-blind parallel study in IBS patients. A~     total of 60 adult patients diagnosed with IBS-C, -D or -A/M according to Rome IV criteria~     will be included. The participants will be randomized into one of three groups consuming~     either HMO (two groups) or placebo (one group).~      The primary objective of the study is to establish the effect of HMOs on the faecal~     microbiota in IBS patients. Secondary objectives are to assess the effect on gastrointestinal~     symptoms, mucosal immunity, gut barrier function, quality of life, and anxiety and~     depression.~   "
52800|NCT02875834|"~     To evaluate the efficacy of two different doses (5 and 10 g) of ZS orally administered once~     daily (qd) vs placebo in maintaining normokalemia in initially hyperkalemic patients having~     achieved normokalemia following two days of initial ZS therapy (10g TID).~   "
52801|NCT02875821|"~     In this study, the investigators investigate beneficial effects of ipragliflozin, newly~     developted SGLT2 inhibitor, on reduction in visceral fat area and degree of fatty liver in~     subjects with T2DM when added to metformin and pioglitazone therapy.~   "
52802|NCT02875808|"~     The value of CSF IL-6, IL-8 and Procalcitonin in detecting an early diagnosis of intrathecal~     infection in neurosurgical patients with an external ventricular drainage is evaluated.~   "
52803|NCT02875795|"~     The hypothesis of the present study is that an automatic assessment technic can measure the~     impact of the speech disorders on the communication abilities giving a severity index of~     speech in patients treated for head and neck and particularly for oral and pharyngeal cancer.~   "
52804|NCT02875782|"~     The study is a randomized controlled trial (RCT) on a tailored smoking cessation intervention~     targeted type 2 diabetic patients who smoke (DM intervention). The objectives are:~        1. to study the effectiveness of the DM intervention in achieving (a) smoking cessation,~          (b) smoking reduction, and (c) progress to a higher stage of readiness to quit;~        2. the changes in levels of HbA1c between (a) the intervention group and the controls, and~          (b) quitters and continuing smokers;~        3. the predictive factors for the success of the outcomes above.~   "
52805|NCT02875769|"~     The aim of this randomized, single blinded clinical trial was to evaluate the effect of a~     pre-procedural mouthwash containing cetylpyridinium chloride (CPC), zinc lactate (Zn) and~     sodium fluoride (F) in the reduction of viable bacteria in oral aerosol/splatter after a~     dental prophylaxis with ultrasonic scaler.~   "
52806|NCT02875756|"~     The investigators plan to evaluate the effect of the number of needle revolutions inside the~     node on the diagnostic yield of endobronchial ultrasound-guided transbronchial needle~     aspiration (EBUS-TBNA) in patients with sarcoidosis.~   "
52807|NCT02875743|"~     Invasive fungal disease (IFD) is an important cause of mortality and morbidity in patients~     undergoing intensive chemotherapy or transplantation.~      This current study aims to assess the impact of prophylactically using the broad-spectrum~     anti-fungal agent posaconazole on the incidence of IFD in high risk patients with aplastic~     anaemia and those undergoing intensive chemotherapy, for example for acute myeloid leukaemia,~     and allogeneic stem cell transplantation.~   "
52808|NCT02875730|"~     This is a prospective trial investigating the effectiveness of a modified MRI preparatory~     pulse sequence to improve pulmonary vein isolation visualization.~   "
52809|NCT02875717|"~     Retrospective Analysis of patients that received shockwave lithotripsy as Treatment of~     ureteral or kidney Stones. Condition examinated is the effect of low molecular weight~     Heparins and acetylsalicylic acid on the Formation of renal hematoma after shockwave~     lithotripsy. Primary outcome is documented hematoma in a postoperative ultrasound control.~     Secondary outcomes are perioperative complication, Need for erythrocyte tranfusion,~     interventions for bleeding control, readmission or death within 30 days.~   "
52810|NCT02875704|"~     In this study, markers of oxidative stress will be measured in the aqueous humour of~     stargardt disease, age related macular degeneration and diabetic retinopathy patients~     compared to controls.~   "
52811|NCT02875691|"~     This randomized double blind clinical trial performed on 68 patients (32 in intervention and~     36 in control group) diagnosed with SLE. The patients in intervention group were given daily~     dose of 1000mg of aqueous green tea extract (of 6 gram of dried green tea leaf) in form of~     two capsules ( 500 mg). Also in control group, the patients were given daily dose of 1000mg~     of cellulose in form of two capsules ( 500 mg) Variables include SLE disease activity, some~     biomarkers of inflammation and oxidative stress and anthropometric indicators at baseline and~     end of the study.~      The investigators used SLEDAI (systemic lupus erythematous disease activity index )~     questionnaire for evaluating the clinical signs of the disease. The questionnaires filled out~     at baseline and after 3 month.~   "
52812|NCT02875678|"~     A Single-Dose Study to Evaluate the Effects of ABX-1431 on Gastric Accommodation and Nutrient~     Volume Tolerance in Patients with Functional Dyspepsia.~   "
52813|NCT02875665|"~     This research aims to investigate the feasibility for the treatment of OnPulse(TM) for the~     treatment of faecal incontinence (FI) (including mixed faecal and urinary incontinence) in~     older people living at home or in a Care Home. It will determine patient acceptability,~     tolerability and usability of the T-2 gekoTM device for FI by assessing:~        1. device user factors: acceptability of use, ease of device placement, ease of device~          interface control and understanding of device instructions;~        2. tolerability of device: skin tolerability.~   "
52814|NCT02875652|"~     Quantification and follow-up during 3 years of circulating tumoral DNA in patients with~     choroidal melanoma~   "
52815|NCT02875639|"~     The main purpose of this research is to reveal the curative effect mechanism of Yiqihuoxue~     prescription which treat the disease of qi deficiency and blood stasis. And at the same time~     this study also try to confirm yiqi huoxue fang qi deficiency blood stasis treatment of~     coronary heart disease (CHD) heart failure the curative effect and security.~   "
52816|NCT02875626|"~     This is a single-center prospective study evaluating the diagnostic performance and safety of~     Infracyanine in women with early breast cancer whose the research of sentinel node(s)~     combines isotopes and Infracyanine.~   "
52817|NCT02875613|"~     The purpose of this study is to determine whether avelumab, an investigational antibody~     against programmed death-ligand (PD-L1), has an effect on recurrent nasopharyngeal cancer.~     Avelumab is designed to block the interaction between programmed cell death protein 1 (PD-1),~     a known immune checkpoint, and PD-L1. By blocking this interaction, the immune system may be~     stimulated, allowing it to more effectively recognize and attack the cancer.~   "
52820|NCT02875574|"~     The 'rising tide' of antimicrobial resistance is a source of concern across most infectious~     diseases. In the UK, for example, 6.8% of the ~8,500 tuberculosis patients seen in 2012 were~     resistant to the cheap and effective first-line drug isoniazid. It is of great importance to~     prevent the loss of current anti-tuberculosis drugs and preventing the spread of resistance~     by treating such patients as well as possible.~      Currently, guidance on the best treatments for isoniazid resistant tuberculosis is~     inconsistent globally. Data from randomised controlled trials, the peak quality of evidence,~     is sparse. It is thus important that studies using pre-existing observational data are~     undertaken.~      The investigators aim to use data and samples collected from Public Health England and~     National Health Service hospitals to determine a) the best treatments for patients with~     isoniazid resistant tuberculosis disease (cohort study) and b) how different causes of drug~     resistance in the infecting bacteria influence a) (nested case-control study). Eligible~     participants will have had isoniazid resistant tuberculosis (without associated rifampicin~     resistance) in England between 2009 and 2013 and will have been notified to Public Health~     England. The study will be conducted at University College London, National Health Service~     hospitals and Public Health England and will last until December 2017. Patient hospital~     records and disease surveillance records will be accessed and cultured bacteria from~     previously stored samples sequenced.~   "
52821|NCT02875561|"~     The primary objective of this study is to evaluate the incidence of vulva dysplasia~     recurrence within 12 months of treatment with Carbon Dioxide (CO2) laser ablation or~     ultrasonic aspiration.~   "
52822|NCT02875548|"~     This study will provide continuing availability to tazemetostat as a single agent to subjects~     who have completed their participation in an antecedent tazemetostat study (either with~     monotherapy or combination therapy). In addition, long-term safety and overall survival will~     be collected.~   "
52823|NCT02875535|"~     Reducing youth suicide in the U.S. is a national public health priority. Sexual and gender~     minority adolescents are at elevated risk for suicide. Safer school environments, however,~     can decrease this risk. This study capitalizes on the critical role of school nurses in~     improving the mental health of this vulnerable population through implementation and~     sustainment of evidence-based strategies to enhance school environments. In addition to~     suicide, the conceptual framework and methods for this novel, nurse-led intervention can be~     applied to address the health-related concerns of other pediatric populations encountered in~     school settings as well.~   "
52824|NCT02875522|"~     The primary cause of chronic obstructive pulmonary disease is smoking, which can lead to~     inflammation in the lungs and blood vessels that can lead to secondary problems such as blood~     vessel disease, high blood pressure and heart disease. Aerobic exercise training has been~     shown to reduce the risk of heart and brain disease; however, it is currently unknown whether~     exercise training can have the same affect in patients with COPD. The aim of this study is to~     investigate how eight weeks of aerobic exercise training improves blood vessel and heart~     function and brain blood flow in patients with COPD.~   "
52825|NCT02875509|"~     One hundred patients, aged from 41 to 78 years, underwent open heart surgery in the years~     1998-1999 and were studied by using the Cellstick device for harvesting wound inflammatory~     cells during the first 24 hours after surgery. The results of the differential count were~     computerized by using artificial neural network for obtaining wound inflammatory cell node~     (WICN). The patients were followed up for sixteen years or to the death. WICN values were~     compared with the patients´ survival.~   "
52826|NCT02875496|"~     Establishment of a BNA reference database for the Adult and Elderly Population.~     Hypothesis-generating study designed to collect data that will aid in future scientific and~     engineering exploration of correlations between clinical assessments and BNA scores. The~     results are primarily intended for scientific inquiry and engineering development purposes,~     and may be used in future regulatory submissions.~   "
52827|NCT02875483|"~     Over 50% of all pregnancies that occur in the US are unintended, and unintended pregnancy is~     detrimental to maternal and child health. Tubal sterilization may be performed immediately~     following a delivery, or as an interval procedure remote from pregnancy. Many women request~     sterilization to follow delivery, but it is frequently not completed during the peri-partum~     hospitalization. Women who are denied an immediate post-partum tubal are generally candidates~     to complete the procedure as an interval surgery within a few months of delivery, but few do~     so. Women who request tubal sterilization and do not receive it are at highest risk for a~     rapid repeat pregnancy, with as many as 46% having an unintended pregnancy within 1 year.~      The standard care at many institutions for a patient denied tubal sterilization during~     hospitalization is to offer a short term contraceptive and instruct the patient to follow up~     for the standard post-partum outpatient visit in 4-6 weeks. If the patient still desires~     tubal sterilization at that time, the surgical procedure will be scheduled. No-show rates for~     post-partum care are high at about 50%-60%, and therefore, many patients are never scheduled~     for their surgery. If the process of scheduling interval tubal sterilization surgery could be~     expedited, rates of completion could be improved.~   "
52828|NCT02875470|"~     This study compares the efficacy of diamond burs and Gracey curettes in non-surgical~     periodontal treatment of chronic periodontitis by clinical, microbiological, biochemical~     parameters and scanning electron microscopic investigations on root surfaces. Two quadrants~     of each of the 12 patients were treated with diamond burs whereas other 2 quadrants were~     treated with Gracey curettes. Also 21 hopeless teeth received root planing either with~     diamond burs or curettes or no treatment at all and were then extracted for microscopic~     evaluations.~   "
52829|NCT02875457|"~     Apatinib has been approved as a second-line treatment for advanced gastric cancer. Several~     phase III clinical studies of non small cell lung cancer, liver cancer, colorectal cancer and~     other tumors also showed apatinib has less toxic side effects and better patient tolerance.~     However, the clinical application of apatinib in small cell lung cancer is still lack of~     evidence-based medicine. Etoposide and cisplatin chemotherapy is the first-line treatment for~     small-cell lung cancer. The purpose of this multicenter, randomized, prospective study is to~     investigate the efficacy and safety of apatinib as the maintenance therapy for extensive~     stage small cell lung cancer after combined with etoposide and cisplatin chemotherapy.~   "
53606|NCT02865304|"~     The purpose of the present study was to prospectively evaluate the efficacy and safety of~     endostar, a recombinant product of endostatin, combined with taxane-based regimens for HER-2~     negative metastatic breast cancer (MBC) patients.~   "
52830|NCT02875444|"~     Screening for an abdominal aortic aneurysm, monitoring its growth and evaluation of its risk~     of rupture are based on the measure of its maximum diameter. The abdominal aortic aneurysm's~     treatment to prevent its rupture is recommended from a threshold of 50-55 mm in men and of~     45-50 mm in women.~      The importance of this measure for patient management justify a specific and homogeneous~     protocol of measure. However, the diversity of methods of measuring the maximum diameter with~     scanner and ultrasound was shown.~      The impact of various angio-CT based measures of maximum AAA diameter, and the impact of~     reproducibility limits on the decision to operate have never been investigated.~   "
52831|NCT02875431|"~     Detect the reason for the frequently occurring C5 palsy after anterior cervical discectomy~     and fusion~   "
52832|NCT02875418|"~     Background:~      Identification and measurement of uterine contractions throughout pregnancy and labor is~     crucial to the well being of both mother and fetus. Prematurity is one of the major causes~     for adverse pregnancy outcomes, and clinical decision-making often relies on uterine~     frequency as recorded by a tocodynamometer, as well as on other methods including sonographic~     cervical length, pelvic examination.~      Objective:~      To show that the use of the EUM in preterm labor is effective in establishing true preterm~     labor.~   "
52833|NCT02875405|"~     The purpose of this study is to determine if preforming a posterior left pericardiotomy~     prevents atrial fibrillation after cardiac surgery.~   "
52834|NCT02875392|"~     Studies reveal special function of fucoidan so far include anti-virus, anti-tumor,~     immunomodulatory, anti-inflammatory, blood fat, anti-oxidation and liver and kidney~     dysfunction and improve fibrosis. The subject of this study focus on assessing the impact on~     the metabolism of fatty liver and liver fibrosis after taking oral FucoHiQ capsules.~   "
52835|NCT02875379|"~     Background. Non invasive positive pressure ventilation (NIV) is among first line treatments~     of acute respiratory failure. Several interfaces are available for non-invasive~     ventilation.Despite full face and oronasal masks are more frequently used, some evidence~     suggests that helmets may optimize patients' comfort and NIV tolerability.~      During NIV, humidification strategies (heat and moisture exchangers HME or heated humidifiers~     HH) may significantly affect patient's comfort and work of breathing.~      Despite physiological data suggested heated humidification as the best strategy during NIV~     with full face masks, no differences were found in a randomized controlled study assessing~     the effects of HME or HH on a pragmatic clinical outcome.~      However, the higher dead space (i.e. 18 L/min) and rebreathing rate observed during helmet~     NIV make such results not applicable to this particular setting.~      The investigators designed a randomized-crossover trial to assess the effect of four~     humidification strategies during helmet NIV on patients with acute respiratory failure, in~     terms of comfort, work of breathing and patient-ventilator interaction.~      Methods. All awake, collaborative, hypoxemic patients requiring mechanical ventilation will~     be considered for the enrollment. Hypercapnic patients (i.e.PaCO2>45 mmHg) will be excluded.~      Each enrolled patient will undergo helmet NIV with all the following humidification~     strategies in a random order. Each period will last 60 minutes.~        -  Passive humidification, double tube circuit.~        -  Heated humification (MR 730, Fisher & Paykel, Auckland, New Zealand), humidification~          chamber temperature 33°C.~        -  Heated humification (MR 730, Fisher & Paykel, Auckland, New Zealand), humidification~          chamber temperature 37°C.~        -  Passive humidification with HME, Y-piece circuit.~      Ventilatory settings (Draeger Evita xl or Evita infinity ventilators):~      Pressure support ventilation; pressure support=20 cmH20; FiO2 titrated to obtain SpO2 between~     92 and 98%; positive end-expiratory pressure=10 cmH2O; maximum inspiratory time 0.9 seconds;~     inspiratory flow trigger = 2 l/min; expiratory trigger: 30% of the maximum inspiratory flow;~     pressurization time=0,00 s.~      Such settings will be kept unchanged during the whole study period. An oesophageal catheter~     will be placed and secured to measure oesophageal pressure (Pes) and gastric pressure (Pga)~     (Nutrivent, Italy): the reliability of the measured pressure will be confirmed with an airway~     occlusion test during NIV with oronasal mask. Work of breathing will be estimated with the~     pressure-time product (PTP) of the pleural pressure.~      A pneumotachograph (KleisTek) will record flow, airway pressure, Pes and Pga on a dedicated~     laptop.~      At the end of each cycle, the patient will be asked to rate his/her discomfort on a visual~     analog scale (VAS) modified for ICU patients. The level of dyspnea will be assessed with the~     Borg dyspnea scale.~      The following parameters will be record at the end of each cycle:~      Arterial pressure, heart rate, respiratory rate, SpO2, pH, PCO2, PaO2, SaO2. Airway and~     esophageal pressure signals will be reviewed offline to detect patient-ventilator~     asynchronies (ineffective efforts, double cycling, premature cycling, delayed cycling) and~     asynchrony index (number of asynchrony events divided by the total respiratory rate computed~     as the sum of the number of ventilator cycles (triggered or not) and of wasted efforts) will~     be computed. The trigger delay will be also measured. The pressurization and depressurization~     velocity will be assessed with the PTP airway index 300 and 500 (inspiratory and expiratory),~     as suggested by Ferrone and coworkers. The work of breathing (WOB) for each breath will be~     estimated by PTPes.~      An hygrometer (Dimar SRL, Italy) will measure and record on a dedicated laptop Helmet~     temperature, relative and absolute humidity.~      Primary endpoints: patient's comfort, work of breathing and asynchrony index.~      Sample Sizing:~      Given the physiological design of the study, the investigators did not make an a priori~     sample size and plan to enroll 24 patients.~   "
52836|NCT02875366|"~     This is a Phase 4, randomized, double-blind, placebo-controlled, parallel-group study in~     subjects aged 12 years and older with CF who are homozygous for the F508del-CFTR mutation.~     This study is designed to evaluate the effect of LUM/IVA on manifestations of CF affected by~     exercise tolerance & training.~   "
52837|NCT02875353|"~     The primary specific aim is to perform a randomized controlled trial (RCT) to compare rates~     of delayed hemorrhage after DEP detection of arterial blood flow and focal treatment in~     PPIU's (treatment arm) with standard treatment using medical guidelines alone (controls) for~     prevention of delayed bleeding in high risk patients (on anti-coagulants or anti-platelet~     drugs or with large ulcers) after snare resection of benign colon polyps.~   "
52838|NCT02875340|"~     The objectives of this study are to assess the safety, tolerability, pharmacokinetics and~     efficacy of VAL401 in the treatment of patients with locally advanced or metastatic non-small~     cell lung adenocarcinoma.~   "
52839|NCT02875327|"~     Background:~      The SEER database collects data about people with cancer. SEER stands for Surveillance,~     Epidemiology, and End Results. Medicaid is a kind of health insurance. It is for people who~     have low income or serious medical needs. Many studies have shown that Medicaid recipients~     with cancer are more likely to be diagnosed later in the disease than people with other~     insurance. They are also less likely to get treatment. Researchers want to compare Medicaid~     data and SEER data. They want to make this available to other scientists.~      Objectives:~      To link people in the SEER database to Medicaid data for the years around their cancer~     diagnosis. To create a file that contains SEER case numbers linked to Medicaid numbers.~      Eligibility:~      No people are enrolled in this study.~      Design:~      The SEER finder file will be securely uploaded to the CMS Data Center.~      The finder file will be matched against the Medicaid Personal Summary file at the CMS Data~     Center.~      If participants appear in both the SEER file and Medicaid file, their data will be extracted.~      The dates of Medicaid data will be compared with the SEER date of diagnosis. Researchers will~     see if the Medicaid dates fall in certain periods. These are 12 months before, the month of,~     and 11 months after diagnosis.~      If participants are eligible for Medicaid for these periods, a flag will be created in the~     file. It will note the participants is eligible and why.~      The SEER finder file will be destroyed.~      The only data saved will be:~      Each participant's unique random SEER case number linked to their Medicaid number~      Monthly flags about Medicaid eligibility~   "
52840|NCT02875314|"~     This is a prospective randomized clinical trial, to determine whether dose-intensive tandem~     Consolidation, in a randomized comparison with single cycle Consolidation, provides an~     event-free survival (EFS) and overall survival (OS). The study population will be high-risk~     patients (non-Wnt and non-Shh sub-groups) with medulloblastoma, and for all patients with~     central nervous system (CNS) embryonal tumors completing Head Start 4 Induction. This study~     will further determine whether the additional labor intensity (duration of hospitalizations~     and short-term and long-term morbidities) associated with the tandem treatment is justified~     by the improvement in outcome. It is expected that the tandem (3 cycles) Consolidation~     regimen will produce a superior outcome compared to the single cycle Consolidation, given the~     substantially higher dose intensity of the tandem regimen, without significant addition of~     either short-term or long-term morbidities.~   "
52841|NCT02875301|"~     This randomized control trial will examine whether a 12 month monitored exercise intervention~     improves brain health in cognitively normal older adults. This trial will also address~     several important unanswered questions: (1) Are the recommended public health guidelines of~     150 minutes/week of exercise sufficient for improving cognitive performance? (2) Does~     exercise influence brain structure and/or function? (3) Is there a dose-response effect of~     exercise on the above variables such that greater amounts of exercise brings about greater~     benefits in cognitive and brain health? (4) What are the mechanisms by which exercise~     influences brain health? and (5) What factors attenuate or magnify the effects of exercise on~     brain and cognitive health and contribute to the individual variability in intervention~     outcomes?~   "
52842|NCT02875288|"~     Aim: To compare the postoperative outcomes after surgical infiltration with plain bupivacaine~     compared to liposomal bupivacaine in patients undergoing elective, minimally invasive,~     general surgery procedures. To the investigators knowledge, there are no head-to-head,~     prospective, randomized, controlled trials of plain bupivacaine versus liposomal bupivacaine~     to evaluate postoperative pain and return of function.~   "
53652|NCT02864693|"~     The purpose of this research is to evaluate benefits of a microprocessor controlled~     prosthetic ankle-foot device compared to a non-microprocessor controlled or passive carbon~     fiber prosthetic ankle-foot device.~   "
52844|NCT02875262|"~     Aneurysmal subarachnoid hemorrhage (SAH) is a form of stroke in which secondary neurological~     deterioration is an important cause of mortality and morbidity. These secondary changes, so~     called delayed cerebral ischemia (DCI), are caused by lysis of erythrocytes which can react~     to form iron, an toxic substance to the brain. Iron chelators remove the excess of iron and~     are standard care in iron-overloaded patients. Deferoxamine (DFO) an chelator has not been~     evaluated in SAH patients. This study evaluates the safety of deferoxamine in SAH patients~   "
52845|NCT02875249|"~     Chemotherapy is commonly used as myeloablative conditioning treatment to prepare patients for~     haematopoietic stem cell transplantation (HSCT). Chemotherapy leads to several side effects,~     with gastrointestinal (GI) mucositis being one of the most frequent. Current models of GI~     mucositis pathophysiology are generally silent on the role of the intestinal microbiome.~      The aim of the study is to identify functional mechanisms by which the intestinal microbiome~     may play a key role in the pathophysiology of GI mucositis, the investigators applied high~     throughput DNA-sequencing analysis to identify microbes and microbial functions that are~     modulated following chemotherapy.~   "
52846|NCT02875236|"~     Efficacy and safety of octaplasLG® administration vs. crystalloids (standard) in patients~     with septic shock - a randomized, controlled, open-label investigator-initiated pilot trial.~   "
52847|NCT02875223|"~     Study CC-90011-ST-001 is an open-label, Phase 1, dose escalation and expansion,~     First-In-Human (FIH) clinical study of CC-90011 in subjects with relapsed and/or refractory~     solid tumors (including neuroendocrine carcinomas (NEC)) and Non-Hodgkin's lymphomas (NHLs).~     The dose escalation part (Part A) of the study will explore escalating oral doses of CC-90011~     to estimate the maximum tolerated dose (MTD) of CC-90011.~   "
52848|NCT02875210|"~     Actually, there are several laximeters for measuring anterior tibial translational in case of~     anterior cruciate ligament rupture. The most commonly used are telos, KT-1000, GnrB and~     Rolimeter. Results of these instrumented tests, which expressed in differential (millimeters~     values), have a bad correlation between them and so are not comparable in current literature.~     The aim of this study was to compare results of these tests and establish a ratio (pathologic~     knee laxity/ healthy knee laxity) to reduce differences between each instrumented test.~   "
52849|NCT02875197|"~     The purpose of this research is to provide clinically, administratively, and field-relevant~     objective running outcomes by directly comparing running biomechanics of individuals with~     lower extremity amputation (ILEA) using RSPs (Running Specific Prostheses) and traditional~     prostheses. Within this purpose, the project has two specific aims:~      Specific Aim 1: To compare RSPs and traditional prostheses with respect to running ability~     and performance~      Specific Aim 2: To compare RSPs and traditional prostheses with respect to injury risks~     associated with running~      Hypothesis 1a: RSPs will outperform traditional prostheses at all velocities as measured by~     kinetic data (ground reaction forces, joint powers, joint and limb work) and 50m dash time.~      Hypothesis 1b: ILEA intact limbs and able-bodied control limbs will outperform residual limbs~     with RSPs and traditional prostheses at all velocities as measured by kinetic data.~      Hypothesis 2: Running with RSPs will show reduced acute and chronic injury risks compared to~     traditional prostheses at all velocities as measured by loading rates, EMG amplitudes,~     lumbopelvic kinematics, and modeled joint loads.~   "
52850|NCT02875184|"~     This is a multicenter, prospective, non-interventional, observational single arm study.~      Two-hundred patients will be recruited in the Netherlands over a one year period. In all~     cases, the decision to treat the patient with apremilast will be made prior to the decision~     to enter the subject into this study. Treatment will be according to routine clinical~     practice and based on recommendations as per the Summary of Product Characteristics (SPC) of~     apremilast (Otezla®). Each patient will be followed up for a maximum of 24 months.~   "
52851|NCT02875171|"~     Anthracycline therapy is well-known for its adverse cardiac effects. Anthracycline-induced~     cardiotoxicity (AIC) is associated with a poor prognosis; since classical heart failure~     treatment can potentially reverse cardiac dysfunction at the early stage of cardiac toxicity,~     early detection of AIC is crucial.~      Transthoracic echocardiography is recommended for monitoring left ventricular function in~     patients receiving these molecules. In routine practice, left ventricular systolic function~     is mainly assessed by the left ventricular ejection fraction (LVEF), measured by~     two-dimensional echocardiography imaging. However, LVEF depends on the operator's experience~     and is not sensitive enough to detect subclinical myocardial dysfunction.~      To overcome these limitations, two-dimensional speckle-tracking imaging has been proposed.~     This technique allows for a study of global and regional myocardial deformation, especially~     the longitudinal component, which appears to be the most sensitive one. Several studies have~     already emphasized the role of global longitudinal strain (GLS) to detect slight alterations~     in systolic function, especially in the setting of potentially cardiotoxic drugs and even~     after low to moderate doses of anthracyclines. A recent expert consensus paper strongly~     recommends GLS assessment for the detection of subclinical left ventricular dysfunction due~     to anthracycline therapy.~      Although there is growing evidence that GLS can predict subsequent alterations in LVEF, few~     data exist on the optimal timing to perform echocardiography.~      The investigators hypothesized that very early measurement of GLS in the time course of~     anthracycline therapy could predict subsequent left ventricular systolic dysfunction.~      The aim of this study was, therefore, to determine whether assessment of GLS after 150 mg/m²~     of anthracyclines can predict AIC.~   "
52852|NCT02875158|"~     Transscleral cyclophotocoagulation of the ciliary body is an effective technique to reduce~     intraocular pressure in case of glaucoma. Due to concerns over complications, the main~     indications for this second-line treatment are refractory glaucoma medication / surgery and~     low visual prognosis. The 2000 milliwatts (mW) for 2 seconds settings are used by the~     majority of researchers and clinicians according to the published literature. Some have~     proposed using 1250 mW for 4 seconds to improve the use of this medical procedure.~      The aim of this study is to determine how different parameters affect the efficacy of the~     treatment. This is a prospective double-blinded randomized controlled trial comparing two~     groups, the experimental group using 1250 mW for 4 seconds and the control group using 2000~     mW for 2 seconds.~   "
52853|NCT02875145|"~     The follow up time after keratoplasty now routinely exceeds multiple decades. It is common~     for keratoplasty patients to also undergo cataract surgery at a later date in their lives.~      Keratoplasties and cataract surgery both result in local inflammation. This may influence the~     density of endothelial cells, and on average there is a loss of 10% in endothelial cells~     within 3 months of the cataract surgery. Yet, a sufficient density of endothelial cells is~     required to maintain graft transparency. It may be therefore difficult to strike a balance~     between loss of visual acuity due to the cataract of to the loss of graft transparency over~     the long term.~      The investigators aim to compare graft survival in patients with clear crystalline lens with~     and without cataract surgery.~   "
67093|NCT02688738|"~     The purpose of this study is to evaluate the ability of oral doxycycline to decrease the~     colonization of Propionibacterium acnes in the dermis of the shoulder.~   "
52855|NCT02875119|"~     This is a two-part study. The first part is a single-dose open label design. The second part~     employs a multiple dose, randomized, placebo controlled study design. Studies have~     demonstrated that GRFT is highly potent for HIV prevention and is effective at very low~     concentrations. One 4 mL dose of PC-6500, designed to provide an adequate vaginal~     concentration of GRFT for the prevention of HIV, based on preclinical data, will be~     evaluated. Rising dose tolerance is not the goal of this study because GRFT is likely to be~     minimally absorbed systemically, if at all.~   "
52856|NCT02875106|"~     The primary objective in this study is to identify commercial pulse detection systems (CPDS)~     parallel to electrocardiogram (ECG) recording within routine clinical setting, which are able~     to detect atrial fibrillation or sinus rhythm of screened patients.~   "
52857|NCT02875093|"~     Assessment of safety and tolerability of drug combination and determine time on treatment,~     Overall survival (OS) and response rate with patient disease burden, and type of disease~   "
52858|NCT02875080|"~     The ratios of the geometric means of the ODT formulation to those of the reference~     formulation (conventional tablet) for the bioavailability variables (Cmax, AUCt, and AUC∞ of~     brexpiprazole (OPC-34712)).~   "
52859|NCT02875067|"~     This trial is to assess the safety & efficacy of the Combination of Pembrolizumab and~     Lenalidomide in the management of patients with Relapsed Hodgkin Lymphoma.~   "
52860|NCT02875054|"~     Randomized control trial to evaluate uni-manual and bimanual upper limb function as well as~     compare outcomes of varied cast wear in children with hemiplegic cerebral palsy (CP)~     following a hybrid camp model of modified constraint induced movement therapy (mCIMT) and~     hand-arm bimanual intensive training (HABIT).~   "
52861|NCT02875041|"~     This is a feasibility and exploratory pilot study of adjuvant transcranial magnetic~     stimulation (TMS) to physical therapy (PT) for locomotion and balance rehabilitation in~     Parkinson's disease patients.~   "
52862|NCT02875028|"~     Vorapaxar is a recently approved protease activated receptor - 1 (PAR-1) inhibitor. Platelet~     inhibition may also exert positive results on coagulation activation and may beneficially~     influence the inflammatory response. Since vorapaxar is the first available substance of a~     new class of platelet inhibitors its effects on the human coagulation system and the~     inflammatory response will be assessed in the well-established human endotoxemia model.~   "
52863|NCT02875015|"~     Postoperative pain, the quality of their recovery and the opioid consumption following a~     midurethral sling placement are being compared between 2 groups. One group will have the~     hydro-dissection performed with a diluted liposomal bupivacaine solution. The other group~     will have the hydro-dissection performed with a diluted bupivacaine HCL and Lidocaine~     solution.~   "
52864|NCT02875002|"~     This phase 1, multicenter, open-label study is designed to find the RP2D of volasertib, a~     PLK1 inhibitor, and belinostat, an HDAC inhibitor, when given in combination to patients with~     relapsed or refractory B-cell or T-cell lymphoma. A standard 3+3 dose-escalation design will~     be employed with study enrollment beginning at dose level 1.~   "
52865|NCT02874989|"~     The purpose of this study is to determine whether dasatinib and quercetin can reduce the~     expression of pro-inflammatory cells obtained by skin biopsy.~   "
52866|NCT02874976|"~     Interventional~   "
52867|NCT02874963|"~     This intervention study is designed to evaluate the effects of non-surgical procedure in~     addition to surgical procedure on systemic inflammation and glycemic control in with type 2~     diabetes mellitus patients with periodontitis in comparison with non-diabetic periodontic~     patients.~   "
52868|NCT02874950|"~     Background:Musculoskeletal discomforts (MSD), especially in the neck, lower back and shoulder~     areas, are some of the most common issues among office workers. The Social Security~     Organization (SOCSO) in Malaysia caps number of cases involving musculoskeletal injuries at a~     maximum of 10,000 per year.~      Objectives: The primary aims of this research were to: 1. Measure the prevalence of MSD in a~     sample of office workers; 2. Test effective methods of reducing lower back, neck and shoulder~     pain in this sample by training exercise, or ergonomics modification, or both of them; and 3.~     Assess discomfort scores and the range of motion of the lower back, neck and shoulder muscles~     among the office workers after undertaking the different methods for a period of 6 months.~      Methods: In a true experimental design, from 10,000 staff in Telecom Malaysia,onehundred and~     forty two office workers (of whom 50 were male), aged 20-50 y, were allocated randomly, from~     3 different locations (Bangsar, Puchung, and Damansara), to one of three intervention groups~     (receiving training exercise, receiving modified ergonomics, receiving a combination of~     exercise and ergonomics modification) and a control group (receiving none of these~     interventions). The Cornell MSD Questionnaire was used to measure musculoskeletal~     discomforts, with focus on pain severity, before treatment and after 2, 4 and 6 months of the~     interventions. The range of motion (ROM) of the hip, neck, shoulder and knee were measured by~     a 12 inch goniometer, and the Borg CR10 scale was used to measure the perceived exertion of~     training exercises. The rapid office strain assessment (ROSA) questionnaire was used to~     assess the strain associated with office work. Height and weight were also measured to~     calculate the body mass index (BMI).~   "
52869|NCT02874937|"~     Syncope affects about 50% of Canadians, is the cause of 1-2% of emergency room visits, and~     probably is responsible for CDN $250 million in health care spending each year.There is no~     known medical treatment for frequent fainting. Two randomized studies suggest that inhibition~     of norepinephrine transport (NET) reuptake with sibutramine and reboxetine (NET inhibitors)~     prevents syncope on tilt testing by about 80%, and the investigators reported that~     sibutramine markedly reduced the frequency of vasovagal syncope in 7 of our most symptomatic~     patients. Sibutramine and reboxetine, for different reasons, are not available in Canada.~     However atomoxetine is available and is used to help patients with attention deficit~     disorder. There are no data pertaining to its hemodynamic effects in patients with vasovagal~     syncope. Although a randomized clinical trial of atomoxetine for the prevention of vasovagal~     syncope would be needed before clinical use, the investigators first need a proof of~     principle study. The objective is to determine in a prospective, randomized, parallel,~     double-blind study if atomoxetine 40 mg bid in patients at least 18 years old with recurrent~     vasovagal syncope will better prevent syncope during tilt testing than placebo.~   "
54958|NCT02847624|"~     The purpose of this study is to evaluate the safety and effectiveness of tolvaptan in~     patients with autosomal dominant polycystic kidney disease (ADPKD) in the real world clinical~     setting in Japan.~   "
52870|NCT02874924|"~     The ability to mount an effective immune response declines with age, leaving the elderly~     increasingly susceptible to infectious diseases and cancer. Rapamycin, an FDA approved drug~     to prevent transplant rejection, increases the lifespan and healthspan of mice and~     ameliorates age-related declines in immune responsiveness, cancer survival, and cognition in~     laboratory animals. Investigators are conducting a translational trial to test whether~     rapamycin also improves life functions in humans focusing on elderly persons (aged 70-95).~   "
52871|NCT02874911|"~     Exergame training might offer a novel treatment approach even in largely nonambulatory~     subjects with multisystemic degenerative spinocerebellar ataxia.~   "
52872|NCT02874898|"~     This study examines how marijuana use affects processes related to recovery from chronic~     posttraumatic stress disorder (PTSD). Half the participants will be individuals with chronic~     PTSD and heavy marijuana use and half will be individuals with chronic PTSD and no marijuana~     use. This study will assess how individuals with PTSD with heavy or no marijuana use perform~     on a discriminative conditioning and extinction paradigm designed to measure fear extinction~     learning, and how they respond to a brief daily imaginal exposure treatment in regards to~     PTSD symptom reduction.~   "
52873|NCT02874885|"~     Objectives:~        -  To establish the rate of circulating tumor cells (CTC) positivity in patients with~          locally-advanced rectal cancer (LARC), relative to other stages;~        -  To assess changes in detected CTCs associated with neoadjuvant therapy in patients with~          LARC;~        -  To correlate CTC counts with neoadjuvant treatment response as an indicator of disease~          risk.~   "
52874|NCT02874872|"~     The OASIS Collaborative is an organizational intervention aimed at reducing unnecessary~     antibiotic use in skilled nursing facilities. The first target of intervention is the tasks~     carried out by nursing staff after a change in condition and after an antibiotic prescription~     is initiated. The second target are the management staff who provide feedback to staff. The~     third target are the administrators who identify and overcome organizational barriers to~     implementation.~      In this study, we will implement two tools that are intended to minimize unnecessary~     antibiotic use in skilled nursing facilities. The first tool helps skilled nursing facility~     staff assess risk and communicate with prescribers when residents experience a change in~     health status that may result in the use of antibiotics. The second tool is used after an~     antibiotic is prescribed; the tool streamlines reassessment of the patient, and provides~     prescribers the opportunity to consider stopping unnecessary antibiotic prescriptions,~     narrowing the spectrum of antibiotic therapy, or shortening the duration of antibiotic~     therapy.~   "
52875|NCT02874859|"~     This a non-interventional retrospective study on the efficiency and the tolerance of~     intravitreal injections of Aflibercept on vitrectomized eyes in the diabetic macular oedema~   "
52876|NCT02874846|"~     To evaluate effect of Netarsudil Ophthalmic Solution 0.02% on Nocturnal and Diurnal~     Intraocular Pressure.~   "
52877|NCT02874833|"~     A randomized single-blinded prospective study to evaluate the efficacy of an individualized~     supervised 8-week exercise program in subjects with moderate to severe depressive episodes~     compared to treatment-as-usual~   "
52878|NCT02874820|"~     The imdazoline2 binding site (I2BS) is known to reside inside astrocytes. Changes in the~     numbers of I2BS in post mortem tissue has implicated them in a range of psychiatric~     conditions such as depression and addiction, along with neurodegenerative disorders such as~     Alzheimer's disease and Huntington's chorea. Preclinical studies have also demonstrated~     functional interactions with the opioid system, where I2BS ligands have been shown to affect~     tolerance to morphine and alleviate some of the morphine withdrawal syndrome in rats.~     Recently the I2BS and I2BS ligands have been shown to have some interesting analgesic effects~     in different models of pain.~      The location of I2BS on astrocytic glial cells and the possibility that they may in some way~     regulate glial fibrillary acidic protein have led to increased interest into the role of I2BS~     and I2BS ligands in conditions characterised by marked gliosis. The number of I2BS has been~     shown to increase in Alzheimer's disease post mortem, and it has also been suggested that~     I2BS may be a marker for the severity and malignancy of human glioblastomas.~      The lack of suitable imaging tools for the I2BS has meant that information regarding the~     number and distribution of I2BS in the brain has come from preclinical species and in vitro~     post-mortem studies. The recent development of [11C]BU99008 as a suitable PET ligand to~     quantify I2BS in vivo, enables the direct quantification of I2BS availability and regional~     distribution in the living human brain. In this study the investigators plan to utilise~     [11C]BU99008 to quantify the regional brain availability of I2BS in the human brain in vivo~     using PET.~   "
52879|NCT02874807|"~     Syndrome of inappropriate antidiuresis (SIADH) is characterized by an imbalance of~     antidiuretic vasopressin (AVP) secretion. The impaired AVP regulation leads to water~     retention and secondary natriuresis and is a common cause for hyponatremia.~      The therapeutic options, aside from treating the underlying disease, depend upon the onset~     and severity of the symptoms and involve usually fluid restriction or hypertonic saline~     infusion. Alternative therapeutic options are loop diuretics, administration of oral urea or~     vasopressin receptor antagonists (vaptans). Despite those options, there are a considerable~     number of patients which do not sufficiently respond, making additional therapy necessary.~      Empagliflozin (Jardiance)® is a sodium glucose co-transporter 2 (SGLT2)-inhibitor, which is a~     new treatment option developed for patients with diabetes mellitus type 2. The SGLT2 is~     expressed in the proximal tubule and reabsorbs approximately 90 percent of the filtered~     glucose. The inhibition of SGLT2 results in renal excretion of glucose with subsequent~     osmotic diuresis. This mechanism could result in a therapeutic effect in patients with~     hypotonic hyponatremia as in SIADH.~      The aim of this study is to evaluate whether empagliflozin (Jardiance)® has an effect on the~     serum sodium levels of patients with SIADH.~   "
52880|NCT02874794|"~     To determine whether treatment with sacubitril/valsartan provides a superior effect on aortic~     characteristic impedance compared to enalapril in patients with heart failure and reduced~     ejection fraction (left ventricular ejection fraction [LVEF] ≤ 40%) after 12 weeks of~     treatment. The primary endpoint is the change in aortic characteristic impedance (Zc = dP/dQ~     in early systole) between baseline and Week 12.~   "
52881|NCT02874781|"~     This study measures the sublingual microcirculation of patients with kidney transplant using~     MicroScan. The data will be compared with data of health volunteers and end stage renal~     disease patients on hemodialysis.~   "
52882|NCT02874768|"~     This is a single-blind randomized clinical trial. Patients undergoing abdominal surgery will~     be enrolled and randomly divided into two groups: dexmedetomidine group and propofol group.~     In the dexmedetomidine group, patients will receive continuous intravenous infusion of~     dexmedetomidine (infusion dosage range: 0.1 ~ 0.7 mcg/kg/h). In the propofol group, patients~     will receive continuous intravenous infusion of propofol (infusion dosage range: 0.3 ~ 1.6~     mg/kg/h). Hemodynamics will be continuously monitored using a non-invasive monitoring with~     chest bioreactance technique at preset time points (0, 2, 4, 6, 12h and 24h). Clinical data~     such as vital signs, hemodynamic parameters, laboratory results and fluid balance will be~     recorded. The microcirculation will be examined by Cytocam. The following microcirculatory~     parameters will be investigated: total small vessel density, perfused small vessel density,~     microvascular flow index, and heterogeneity index. The enzyme-linked immunosorbent assays~     will be used to measure serum level of endocan, diamine oxidase, and neutrophil~     gelatinase-associated lipocalin at preset time points. The primary goal of this study is to~     compare the effect on microcirculation between dexmedetomidine and propofol in intensive care~     unit patients after abdominal surgery.~   "
52883|NCT02874755|"~     The purpose of this study is to evaluate the impact of the Private Provider Interface Agency~     (PPIA) program on quality of care. The PPIA is a tuberculosis pilot program implemented in~     the private health sector of Mumbai city, India.~   "
52884|NCT02874742|"~     The purpose of this study is to determine if the addition of daratumumab to~     lenalidomide-bortezomib-dexamethasone (RVd) will increase the proportion of participants~     achieving stringent complete response (sCR), as defined by the International Myeloma Working~     Group (IMWG) criteria, by the time of completion of post autologous stem cell transplantation~     (ASCT) consolidation treatment, compared with RVd alone.~   "
52885|NCT02874729|"~     Tumour biomarkers are substances produced by cancer or by other cells of the body in response~     to cancer conditions. They are used to help detect, diagnose, manage and predict outcome or~     recurrence of some types of cancer. Tumour biomarkers can also help doctors choose the most~     appropriate therapy or judge if treatment is successful. Several tumour biomarkers are~     already used in the clinic; however, many others do not meet rigorous scientific standards to~     enter into clinical practice and some solid cancers can be only detected using tissue biopsy,~     a rather invasive procedure. Likewise, evaluating efficacy of novel therapies during clinical~     trials relies on adequate and specific laboratory tests. Therefore novel biomarkers and novel~     methods, to measure them, still represent an un-met clinical need.~      This study aims to develop innovative, more sensitive and reliable tests for better targets,~     in order to assess and monitor circulating cancer biomarkers. Easily accessible samples, like~     blood, will be tested such that invasive tissue biopsies can be avoided. Both healthy~     individuals and cancer patients will be recruited in this study to establish if a laboratory~     test is powerful enough to distinguish between individuals that may have cancer or not.~     Participants' involvement will also support development of novel tests to decide if a novel~     therapy is efficiently counteracting cancer growth or not.~      Participants in the study will be asked to donate blood, sputum, urine or other body fluids,~     depending on the cancer and the assay being developed. After participants give their informed~     consent, the researchers will isolate cells, soluble factors or nucleic acids from body~     fluids. Researchers will then use various laboratory techniques to screen cells, soluble~     factors or nucleic acids for specific markers. This study looks at the effectiveness of using~     laboratory tests to quantify tumour markers in body fluids and, subsequently, to monitor~     patients' response to treatments.~   "
52886|NCT02874716|"~     The purpose of this study is to evaluate the impact of the Private Provider Interface Agency~     (PPIA) program on quality of health care. The PPIA is a tuberculosis pilot program~     implemented in the private health sector of urban Patna in the state of Bihar, India.~   "
52887|NCT02874703|"~     In this study, investigators plan to test two potential mechanisms contributing to diastolic~     dysfunction among asymptomatic persons with HIV who are on cART. The first proposed mechanism~     is that heightened systemic immune activation/inflammation in HIV contributes to myocardial~     inflammation, which in turn promotes myocardial fibrosis. The second mechanism is that~     ectopic fat deposition (increased visceral adiposity) in HIV relates to increased~     intramyocardial lipid content, which in turn contributes to diastolic dysfunction. Both HIV~     positive and HIV-negative participants will undergo cardiac MRI/ MRS imaging studies for~     evaluation of myocardial fibrosis, myocardial inflammation, and intramyocardial lipid~     content. Traditional markers of CVD risk, inflammatory markers/immune, hormonal markers, and~     markers of myocardial stretch/injury will be assessed in relation to cardiac MRI/MRS~     outcomes.~   "
52888|NCT02874690|"~     The overall goal of this research is to use neurophysiological measures to profile strengths~     and deficits for Attention Deficit Hyperactivity Disorder co-morbidity in Autism Spectrum~     Disorder to clarify diagnosis and to predict treatment response.~   "
52889|NCT02874677|"~     Multiple sclerosis (MS) is a disease affecting the white matter of the central nervous~     system. In France, it concerns approximately 80 000 patients and represents one of the most~     frequent neurological affections in young adults. Effort deconditioning of people affected by~     MS is already proven, but it is not just linked to the disease itself. The decrease of~     capacities to produce an effort is aggravated by neurovegetative and cardiovascular~     disorders. The limitation or the complete stop of physical activity is often linked to the~     fear of a handicap aggravation. Causes of stop are multiple, including fatigue and balance~     disorders, even if the handicap level is low (average EDSS = 2). Walking disorders generated~     by MS are frequent, represent the first symptom of the disease (10 to 20 % of cases) and~     alter significantly the quality of life.~      Some reeducation programs were proposed in hospitalization with some efficiency on functional~     capacities. It is now admitted that physical exercise is not noxious, and allows the~     implementation of effort reeducation for MS. Randomized controlled studies have shown in MS~     patients an improvement of physical abilities, of O2max (aerobic capacity), of quality of~     life and a decrease of fatigue. For MS, only a few studies estimate the effect of effort~     reeducation on treadmill. Unfortunately, the efficiency of these programs on walking~     endurance are controversial.~      During the maximal cardiorespiratory effort test, the ventilatory threshold 1 (VT1)~     corresponds to a greater increasing of CO2 compared to O2. The identification of VT1 allows~     the precise determination of the limit from which the body is incapable of producing the~     necessary energy to realize an effort using the aerobic metabolism. The VT1 is situated at a~     level of load with enough intensity for the subject to support the test without dyspnea. A~     VT1 lower than 40 % of the theoretical VO2 max is considered as a marker of maladjustment to~     effort due to dyspnea and excessive muscular fatigue. This indication is very informative~     about the quality of life of patients.~      The goal of this study is to apply a personalized reeducation concerning the working load~     pre-hyperventilation to deconditioned subjects, easily worried by effort induced~     breathlessness and fatigue in order to get the optimization of the aerobic function. The~     hypothesis is that reeducation at this level improves the distance of walking and the quality~     of life of patients affected by MS.~   "
52890|NCT02874664|"~     Study to evaluate the effect of rovalpituzumab tesirine on cardiac ventricular repolarization~     in subjects with small cell lung cancer (SCLC).~   "
52891|NCT02874651|"~     This study will enroll patients with non-metastatic nasopharyngeal carcinoma (NPC) that have~     residual Epstein-Barr virus (EBV) DNA after curative radiotherapy or chemoradiotherapy. The~     purpose is to evaluate the survival in these patients treated with apatinib (YN968D1), an~     inhibitor of vascular endothelial growth factor receptor (phase IIa) and to compare the~     survival in these patients treated with apatinib versus placebo (phase IIb).~   "
67820|NCT02679209|"~     A clinical and radiographic evaluation of 2 regenerative techniques, bioresorbable membrane~     and bone allograft for management of periodontal intrabony defects.~   "
52892|NCT02874638|"~     Protein requirements in individuals who participate in endurance-based exercise training have~     been suggested to be greater than the current recommended dietary allowance (RDA).~      The biological value of protein depends on its amino acid composition. Essential amino acids~     are believed to have main role on whole body protein metabolism. However, it remains to be~     determined what role non-essential amino acids (NEAA) may have in regulating protein~     metabolism and contributing to the increased protein requirements after endurance exercise.~      The indicator amino acid oxidation (IAAO) method has clarified the individual amino acid~     requirement in children, normal healthy adult and clinical populations. However, the IAAO~     method has never been utilized for assessing the effect of NEAA on protein requirements after~     endurance exercise.~      The objective of the current study is to investigate the importance of NEAA for~     endurance-trained male subjects.~   "
52893|NCT02874625|"~     In this randomized clinical trial, the bio-compatibility of 2 materials used for dental~     restorations will be compared: glass-ionomer vs resin-based composites.~      Urine and saliva samples will be taken for determination of bisphenol A levels at several~     time points, and for analysis of the estrogenic activity using ERE-CALUX.~      Also buccal cells will be taken. Next, DNA extraction will be done with a commercial kit.~     Global alterations in DNA methylation and DNA hydroxymethylation levels will be determined~     using UPLC-MS/MS.~   "
52894|NCT02874612|"~     Background: The often studied psychosocial correlates that relate to health outcomes in~     adolescents with Type 1 Diabetes (T1D) are factors such as self-efficacy, depression,~     distress, quality of life, and adherence. These psychosocial factors are not well-studied~     within a young adult (YA) population and the parents of YAs during the transition planning~     phase. Impact: This study aids program development for pre-transfer educational interventions~     to ensure more successful post-transfer health outcomes from both a patient and parent~     perspective. Methods: This longitudinal study is designed to characterize the psychosocial~     factors relevant for a population of YA with T1D. Data analyses of these psychosocial and~     transition readiness variables allow for understanding of prospective health outcomes for~     young adults with T1D during the transition process. Implications/Future Directions: From a~     clinical perspective, the outcomes of this feasibility study will be two-fold: (1) establish~     which of the clinical measures used in the study are related to meaningful health outcomes in~     this young adult population in order to determine future standardized assessments in the~     Diabetes Center and (2) determine which psychosocial constructs are relevant to health~     outcomes to then more fully develop the Diabetes Center's transition program interventions to~     improve functioning clinic-wide (e.g., group day sessions). Finally, it would be attractive~     to various National Institutes of Diabetes and Digestive and Kidney Disorder (NIDDK) grant~     mechanisms to identify the relevant psychosocial measures that assess the psychosocial~     functioning of YA with diabetes after they transfer to adult care.~   "
52895|NCT02874599|"~     Adult patients who require multiple dental restorations will be included in this study. Urine~     and saliva samples will be taken for determination of bisphenol A levels at several time~     points, and for analysis of the estrogenic activity using ERE-CALUX.~      Also buccal cells will be taken. Next, DNA extraction will be done with a commercial kit. We~     will determine global alterations in DNA methylation and DNA hydroxymethylation levels using~     UPLC-MS/MS.~   "
52896|NCT02874586|"~     An open-label,pilot study to evaluate the efficacy and safety of plasma exchange combination~     of immunosuppressive regimens, for the remission of autoimmune hepatitis (AIH).~   "
52897|NCT02874573|"~     This study is a Phase 1 clinical trial to determine the safety, tolerability, and efficacy of~     Tocilizumab (Actemra) as an adjunct to antipsychotic medications in stable outpatients with~     schizophrenia. Tocilizumab (structural formula C6428H9976N1720O2018S42) is a recombinant~     humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin~     G1 (IgG1) subclass. Tocilizumab is formulated as a concentrate for solution for infusion, and~     will be administered by intravenous infusion.~      The investigators propose a 12-week randomized controlled trial of tocilizumab, given in~     adjunct to antipsychotics, in N=20 stable outpatients with schizophrenia or schizoaffective~     disorder and evidence of increased inflammation in the peripheral blood (high-sensitivity~     C-reactive protein [hsCRP]>0.5 mg/dL). The investigators hypothesize that adjunctive~     treatment with tocilizumab will be associated with significant improvement in cognition~     compared to placebo in patients with schizophrenia, and baseline IL-6 levels are higher in~     tocilizumab-treated responders versus non-responders, and there will be greater decreases in~     hsCRP from baseline to week 12 in tocilizumab-versus placebo-treated responders, with~     response defined as ≥0.5 standard deviation (SD) improvement in cognition. Tocilizumab is~     administered as an intravenous infusion every 4 weeks. Following a screening evaluation,~     participants will receive three infusions of siltuximab, one at baseline, another at week 4~     of the study, and another at week 8. The investigators will measure changes in cognitive~     function and symptoms over a 12-week period. Complementing previous positive clinical trials~     of non-steroidal anti-inflammatory drugs, this would be a proof-of-concept study that~     targeting specific cytokines is a viable treatment for schizophrenia.~      Interleukin 6 and its receptor were discovered and cloned at Osaka University, Japan, by~     Tadamitsu Kishimoto in the 1980s. In 1997, Chugai Pharmaceuticals began the clinical~     development of tocilizumab for the treatment of rheumatoid arthritis. Clinical studies for~     Castleman's disease and systemic juvenile idiopathic arthritis started in 2001 and 2002,~     respectively. Hoffmann-La Roche co-developed the drug due to a license agreement in 2003.~      On 11 January 2010, Tocilizumab was approved by the U.S. Food and Drug Administration (US~     FDA) as Actemra for the treatment of rheumatoid arthritis. The FDA approved tocilizumab for~     the treatment of systemic juvenile idiopathic arthritis for children from two years of age in~     April 2011.~   "
52898|NCT02874560|"~     In a population of patients suffering from schizophrenia being treated for an episode of~     clinical destabilization and followed for a period of twelve months, the main objective is to~     evaluate the proportion of patients achieving functional remission and its relationship to~     clinical remission.~   "
52899|NCT02874547|"~     Community Health Workers (CHWs) using patient stories to support hypertension management is a~     randomized controlled trial to evaluate the implementation of a CHW-delivered culturally~     appropriate storytelling intervention for english and spanish-speaking patients diagnosed~     with hypertension who receive care at community health center settings.~   "
52900|NCT02874534|"~     The overall goal of this project is to develop a novel transdiagnostic treatment for~     anhedonia, called Behavioral Activation Treatment for Anhedonia (BATA), using ultra-high~     field functional neuroimaging. There is a critical need for a validated treatment that~     specifically targets anhedonia, and this project will evaluate the effects of this new~     treatment on anhedonia and will establish how this treatment impacts brain systems that~     mediate reward processing, clinical symptoms of anhedonia, functional outcomes, and~     behavioral indices of reward processing. This work will also identify brain targets by which~     future novel anhedonia treatment may be evaluated.~   "
52901|NCT02874521|"~     The purpose of the trial is to compare the effects of intra-dialytic low-frequency electrical~     muscle stimulation and intra-dialytic cycling, with usual care haemodialysis without exercise~     training.~   "
52903|NCT02874495|"~     Crohn's disease goes along with an alteration of the quality of life, even in remission and~     has a negative impact on stress management linked to the pain and the health. Conversely,~     stress and psychological variables play a significant role in the pathogenesis of this~     disease. These interrelations reflects the link between the brain and the digestive tract,~     called brain-gut axis. The autonomic nervous system (ANS) is the neurological interface,~     relaying in a bidirectional way, informations between the digestive tract and the central~     nervous system (CNS).~      Visceral information can thus modulate the functionnement of CNS's areas involved in pain~     management but also in the management of emotional and cognitive behaviours. Yet, numerous~     work demonstrate the existence of a dysfunction of the ANS during Crohn's disease, with a~     dysautonomia of the sympatho-vagal balance.~      Human brain respond by advance before and during the application of a painful stimulus that~     enable the organism to regulate its nociceptive system in order to handle the aversive~     stimulus incoming, via the activation of brin areas managing the pain, or the raise of pain~     awareness.~      The uncertain and not predictable nature of a painful crisis and/or an inflammatory relapse~     in a chronic disease like Crohn's disease can be the origin of an anticipating apprehension~     and anxiety, that could influence visceral perception (increasing it). Nevertheless, only few~     studies exists about the differential role of certain or uncertain anticipation of the pain,~     despite the fact that they are associated to different emotional, cognitive and behavioral~     responses, and the effect of anticipation on painful visceral perception, have not yet been~     studied for parents in remission of Crohn's disease.~      The main goal is to search during certain and uncertain visceral anticipation, induced by~     distension of an intra-rectal balloon for persons suffering from Crohn's disease in~     remission, compared to control subjects, with an MRI functional study~   "
52904|NCT02874482|"~     Background:~      Patients with schizophrenia are abnormally disturbed by information onsets, which may result~     in a disadvantage in filtering relevant information. It seems that they accord the same~     importance to all objects in a scene without taking into account the relevance of objects~     (cognitive salience) or their emotional charge (salience emotional).~      The paradigm of change blindness offers the interesting possibility of studying sensitivity~     to the sudden irruption of visual information with ecological stimuli in schizophrenia. An~     increased attentional capture by the irruption of visual information would suggest better~     performance in patients than in healthy controls. Moreover, patients are disturbed to~     processing of emotional information, in this way we would like to measure the impact of~     emotional salience on the visual exploration.~      Main aim:~      The main objective is to evaluate, if patients with schizophrenia quickly detect changes~     occurring on irrelevant objects in the understanding of the scene.~      Secondary objectives:~      To evaluate in patients with schizophrenia the impact of emotional salience using the same~     paradigm.~      To separate an explicit response (motors responses) with an implicit response (eye tracking~     measures).~      Methodology:~      30 patients with schizophrenia and 30 healthy controls were asked to detect changes in 96~     scenes with 0 or 1 change (neutral or emotional changes). We will measure the participants'~     speed and accuracy in explicitly reporting the changes via motor responses and their capacity~     to implicitly detect changes via eye movements.~   "
52905|NCT02874469|"~     Sudden death is a public health problem with more than 300,000 cases per year in USA and~     40,000 cases per year in France. Moreover, despite all recent therapeutic improvements~     (therapeutic hypothermia, new techniques of resuscitation…), the prognosis remains~     drastically poor and less than 50% of the patients admitted alive at hospital will survive to~     the event at 1 year.~      Outside all medications and technical care to improve patient prognosis, a psychological~     evaluation looks also critical to detect the occurrence of a post traumatic stress~     syndrome. In fact, along with the event severity, a variable period of amnesia related to~     coma may favor the occurrence of such a syndrome and psychological issues, which at the end~     may lead to impairment of patient quality of life.~      Previous studies have evaluated the impact of an intensive care unit diary on psychological~     distress in patients and relatives in the context of severe traumatisms. Such an evaluation~     has however never been done in the specific setting of sudden death and the frequency of this~     syndrome is unknown in this context.~      Aim The aim of the present study is to evaluate the impact of an intensive care unit diary on~     the occurrence of a post traumatic stress syndrome after a sudden death.~      Secondary objectives~        -  To evaluate the frequency of the occurrence of a post traumatic stress syndrome and~          other psycho traumatic symptoms after sudden death~        -  To evaluate the impact of an intensive care unit diary on the severity of this syndrome,~          psycho traumatic symptoms, and psychopathologic comorbidities~        -  To evaluate the impact of the diary on psycho traumatic symptoms and their severity in~          patient's relatives~        -  To evaluate the satisfaction of the patients and their relatives regarding medical cares~          in both groups (with and without diary)~        -  Comparison of nurse diagnostic (psychological distress) and diagnostic made by dedicated~          personal with a specific formation in psychology~        -  Qualitative evaluation of the diary~        -  Evaluation of the paramedical feeling before and after the diary input in practice~   "
52906|NCT02874456|"~     The purpose of this study is to seek the presence of ZIKV in semen, to determine its~     localization and to assess the efficiency of spermatozoa processing methods to obtain virus~     free spermatozoa.~   "
52907|NCT02874443|"~     This project is a clustered randomized controlled trial of a knowledge translation~     intervention of new ACOG guidelines for the diagnosis of poor progress in labor. The intent~     is to reduce the rate of cesarean section (CS) in first time mothers without increasing~     maternal or neonatal morbidity. The guidelines were developed from data from the Consortium~     for Safe Labor. The unit of randomization will be sites in Alberta that deliver~   "
52908|NCT02874430|"~     This phase II trial studies how well metformin hydrochloride works together with doxycycline~     in treating patients with localized breast or uterine cancer. Metformin hydrochloride may~     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~     Doxycycline may stop the growth of bacteria by keeping them from making proteins and~     minimized the toxic side effects of anti-cancer therapy. It is not yet known whether giving~     metformin hydrochloride together with doxycycline may be a better way in treating patients~     with localized breast or uterine cancer.~   "
52909|NCT02874417|"~     This investigation examines the efficacy of a 35 minute computerized psychoeducation protocol~     in the reduction of elevated anxiety sensitivity cognitive concerns, a risk factor for the~     development and maintenance of various forms of psychopathology.~   "
52910|NCT02874404|"~     This phase IIa trial studies the side effects and how well TGR-1202 and ibrutinib work in~     treating patients with diffuse large B-cell lymphoma that has returned after a period of~     improvement or does not respond to treatment. TGR-1202 and ibrutinib may stop the growth of~     cancer cells by blocking some of the enzymes needed for cell growth.~   "
52911|NCT02874391|"~     Use of arteriovenous fistula for IV drug administration is controversial and often prohibited~     by nephrologists. However, we have been using this method in our department for years now in~     order to keep the patients 'veins for other fistulas in the future. The aim of this study is~     to evaluate our practice and maybe provide a justification for a larger multi-center study~     given the importance of this subject in patients with chronic renal failure.~   "
52912|NCT02874378|"~     Postoperative renal function recovery is very important to value the operation quality after~     kidney transplantation. Dexmedetomidine is a selective alpha-2 agonist,enhances urine flow~     rate and perioperative renal function. Some animal experiments have revealed its beneficial~     effects against ischemia-reperfusion injury (IRI), our goal is therefore to investigate the~     effectiveness of a recipient treatment with Dexmedetomidine during operation at reducing~     Cystatin C level and enhancing renal function after kidney transplantation.~   "
59341|NCT02790125|"~     The primary purpose of this study is to determine if single doses of BMS-986166 are safe and~     well tolerated in healthy male subjects and female subjects of non-childbearing potential.~   "
52914|NCT02874352|"~     This study will inform the feasibility of the High Resolution Impedance Manometry (HRIM)~     system combined with Automated Impedance Manometry (AIM) analysis as a screening tool for~     dysphagia and aspiration for the intensive care population with tracheostomy. This pilot~     study aims to determine the incidence of dysphagia and aspiration risk in intensive care~     patients with tracheostomy and the investigators hypothesise that the incidence of dysphagia~     in intensive care patients with tracheostomy will be higher than in an age matched~     population.~   "
52915|NCT02874339|"~     The purpose of this study is to determine whether high flow nasal oxygen (HFNO) therapy is~     non inferior to non invasive ventilation (NIV) in the immediate treatment of patients with~     acute hypercapnic cardiogenic pulmonary edema associated with respiratory failure in the~     emergency department.~   "
52916|NCT02874326|"~     The purpose of this study is to determine whether long-acting octreotide is safe and~     effective in the treatment of patients with Rendu-Osler-Weber (e.g. HHT).~      The study hypothesis is that octreotide is safe and will reduce transfusion requirements and~     endoscopy frequency in ROW patients with refractory anaemia due to bleeding gastrointestinal~     telangiectasias.~   "
52917|NCT02874313|"~     Objectives: Main objective: To compare the percentage of patients with new microaneurysm or~     hard exudates after 12 months between the CPAP group and the control group. Secondary~     objectives: To compare the central macula volume, ganglion cell layer thickness and central~     fovea thickness at baseline and 12, 24 and 52 weeks after randomization between the two study~     groups; to compare the percentage of patients who have an improvement loss of visual acuity~     (more than or equal to 15 letters in patients with macular edema and more than or equal to~     five letters in patients without macular edema) among the baseline visit and the weeks 12, 24~     and 52 between the two study groups; to compare the percentage of patients who reach a higher~     level of diabetic retinopathy at 54 weeks between the two study groups; to compare the~     resolution time of central macula thickness from the randomization between the two study~     groups; to compare the glycated hemoglobin at baseline and 12, 24 and 52 weeks after~     randomization between the two study groups; and to compare the serum levels of inflammatory~     cytokines, oxidative stress biomarkers, sympathetic tone, and intake regulator hormones at~     baseline and 12 and 52 weeks after randomization between the two study groups.~      Methodology: Randomized, multicenter, non-blinded, parallel groups, conventional~     treatment-controlled trial of 12 months of duration.~      Subjects will randomize to conventional dietary and pharmacological treatment or conventional~     dietary and pharmacological treatment plus continuous positive airway pressure (CPAP). Study~     subjects: Subjects 35 to 75 years with type 2 diabetes and a clinical diagnosis of mild~     diabetic retinopathy (with or without macular edema), better visual acuity from 20/40 to~     20/320 letters and refraction with a spherical equivalent less than ± 5 diopter.~      Efficacy variables: Thickness of the central sub-field, central subfield volume, ganglion~     cell layer thickness, and presence of clinical or subclinical macular edema, serous retinal~     or retinal pigment epithelium detachment, intraretinal cysts or haemorrhages assessed by~     optical coherence tomography; presence of cotton exudates, microhemorrhages, microaneurysms,~     , microvascular retinal abnormalities, or a vein/artery ratio > 2/1 in examination of ocular~     fundus/retinography; better corrected visual acuity; glycosylated hemoglobin (HbA1c); fasting~     glucose and insulin; homeostatic model assessment (HOMA) and QUICKI indices; lipid profile,~     troponin I, proBNP, homocysteine and C-reactive protein; systemic biomarkers of inflammation,~     oxidative stress, endothelial damage, sympathetic activity and appetite-regulating hormones~     and clinical questionnaires: short form (SF)-12, visual function questionnaire (VFQ25) and~     iPAQ.~   "
52918|NCT02874300|"~     People with memory problems can struggle with everyday activities and may stop doing things~     they want to do. They are more prone to accidents and have a higher risk of falling.~     Occupational therapists can advise how to do daily activities more easily and safely.~     Physiotherapists can teach exercises which increase activity and improve balance, and may~     help maintain memory.~      There is little research on how to make these interventions work for people with memory~     problems. The investigators have developed two activity and exercise programmes suitable for~     people with memory problems. The investigators will study them in a feasibility trial. One~     programme involves high-intensity supervision (50 visits over one year), the other~     moderate-intensity supervision (11 visits over three months). The investigators will compare~     these with standard falls prevention assessment and advice (1-3 therapist visits). The~     investigators will encourage participants to exercise by themselves or with family members~     over the year, and once the programme ends.~      People with early dementia or memory problems will be eligible for this study. If possible,~     the investigators will also recruit a family member. Participants will be recruited from~     memory clinics or the 'Join Dementia Research' register. The intervention will be delivered~     over a maximum of 1 year in their own homes. Researchers will visit to collect information at~     baseline and at 12 months. The investigators will measure ability in activities of daily~     living, activity, quality of life, memory and health service use. Participants will complete~     weekly falls diaries. Intervention persistence will be measured for 24 months.~      The investigators will conduct interviews and discussion groups to help develop the~     programmes, and understand how they work in practice ('process evaluation'). The~     investigators will also do initial work on health economic modelling, dissemination and~     implementation.~      Study findings will be used to refine the intervention, and inform a planned definitive~     randomised controlled trial.~   "
52919|NCT02874287|"~     The purpose of this study is to evaluate whether treated with hydroxychloroquine could~     improve therapeutic effect for patients with high-risk coronary artery disease.~   "
52920|NCT02874274|"~     This is a study to see whether participation in the Edmond J. Safra Interdisciplinary Home~     Visit Program for Advanced Parkinson's (HVP) increases the rate of age-appropriate~     vaccinations in people with advanced Parkinson's Disease (PD) and related disorders. This~     study will evaluate the impact of the HVP on the rate of common illnesses such as flu and~     pneumonia in patients with advanced PD and related disorders over the course of one year.~      As there is currently no data available on the baseline rate of vaccinations in either~     homebound or less disabled PD populations, investigators will seek to establish the baseline~     rate of vaccinations, barriers to getting vaccinated, and baseline healthcare utilization in~     these populations by piloting (Phase 1) and then implementing (Phase 2) a survey via~     telephone interviews. Investigators will then test feasibility of offering influenza and~     pneumococcal vaccinations, as appropriate, to the homebound individuals in our HVP cohort~     (Phase 3), and will compare their pre- and post-intervention rates of both outpatient and~     acute healthcare utilization and self-reported illness.~   "
52921|NCT02874261|"~     Whole-body periodic acceleration (WBPA) is a new, non-invasive, and promising therapy for a~     diverse and growing list of disorders including cardiovascular disease. During WBPA, patients~     lie in the supine position on a bed that is capable of translating back and forth parallel to~     the ground, along the head-to-foot axis of the patient. Thus, this treatment is best~     described as a form of passive exercise. The frequency of the translation (up to 180~     cycles/minute; cpm) as well as the distance traveled (2-24mm) by the bed can be adjusted by~     the patient or health care professional.~      The science behind the therapeutic effects of WBPA still remains largely unknown.~      The investigators are observing how WBPA may impact on sleep and activity in individuals with~     Parkinson's disease.~   "
52922|NCT02874248|"~     This study is conducted to evaluate the effect of single and multiple therapeutic and~     supratherapeutic oral doses of E4/DRSP combinations on PK parameters, safety, tolerability~     and on cardiac repolarization, as detected by QT interval corrected with Fridericia's formula~     (QTcF).~   "
52980|NCT02873494|"~     PhysioFlow® (PF®) is a new cardiac output (CO) monitoring method by impedance cardiography~     (IC), never studied in pediatric intensive care unit (PICU). The aim of the study was to~     compare CO and cardiac index (CI) measurements (IC) by trans-thoracic Doppler~     echocardiography (TTE) (COTTE and CITTE) and PF® (COIC and CIIC) in PICU.~   "
53133|NCT02871479|"~     This trial will be a double-blind, randomized, placebo-controlled, safety, tolerability and~     efficacy trial of SAN007 (5% East Indian sandalwood oil in a cream formulation) treatment~     regimen when administered daily for up to 28 days to patients at least 18 years of age, with~     atopic dermatitis.~   "
52923|NCT02874235|"~     This study compares music therapy with verbal psychotherapy (treatment as usual) in an~     outpatient psychiatric clinic for traumatized refugees. Based on positive results from a~     pilot study, the randomized clinical trial has a non-inferiority design to detect whether~     music therapy is not less effective than verbal therapy carried out by psychologists and can~     serve as a complementary treatment modality (n=70).~      The participants are adult Arabic, English or Danish speaking refugees suffering from~     posttraumatic stress disorder (PTSD). The patients are referred to outpatient treatment by~     their medical doctor. Data collection takes place in three locations of the clinic in Region~     Zealand, Denmark. The music therapy method used is Guided Imagery and Music (GIM).~      Primary outcome is pre, post and 6 months follow-up measures of HTQ (Harvard Trauma~     Questionaire) and two measures of PTSD-8 during treatment. Secondary outcomes are pre, post~     and 6 months follow-up measures of Quality of Life Questionnaire (WHO-5), Dissociation~     Symptom Scale (DSS), Somatoform Dissociation Questionaire (SDQ-20), Revised Adult Attachment~     Scale (RAAS) and physiological measures (salivary oxytocin, betaendorphin and Substance P).~   "
52924|NCT02874222|"~     Breast cancer is one of the most prevalent cancers with 207,090 new cases of breast cancer~     and 39,840 deaths in women predicted for 2010 in the United States. Aromatase inhibitors~     (AIs) are used as first-line adjuvant therapy for postmenopausal women with early stage~     breast cancer. The effectiveness of current therapy is widely recognized to be compromised by~     poor compliance because of aromatase inhibitor-associated musculoskeletal symptoms (AIMSS), a~     syndrome that affects up to 40-50% of women who take these medications. The syndrome that was~     not recognized during the registration trials for this class of drugs, it can lead to~     discontinuation in up to 24% of women over 2 years. Knowledge that can be used to prevent~     discontinuation of these important agents because of severe AIMSS is urgently needed.~   "
52925|NCT02874209|"~     Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease affecting the central and~     peripheral motor neurons, characterized by the rapidity of its evolution (median survival of~     3 years). The pathophysiology of the disease is still poorly understood. Neuronal death~     results from several cellular mechanisms entangled, including mitochondrial dysfunction. The~     absence of diagnostic marker causes a significant delay in diagnosis, on average a year. On~     the other hand, the wish biomarker is important for therapeutic trials. Recently, MRI sodium~     (23Na) demonstrated its importance to detect noninvasively sodium accumulations associated~     with neuronal suffering. This neuronal pain can be caused by mitochondrial dysfunction~     causing the accumulation in the sodium and calcium cell causing neuronal death. These studies~     were conducted in multiple sclerosis, Alzheimer's disease, Huntington's disease, stroke and~     brain tumors. They demonstrated that sodium MRI could be an effective and sensitive biomarker~     for detecting and quantifying neuronal degeneration. The goal of this study is to assess~     neuronal damage noninvasively by MRI sodium in amyotrophic lateral sclerosis.~   "
52926|NCT02874196|"~     The purpose is to determine diagnostic performances of flat panel dual energy arthrography~     and arthro-tomosynthesis in identification of loosening of painful hip prosthesis, taking as~     reference the results of surgery performed 6 months after arthrography.~      Secondary purposes are:~        -  To describe the level of concordance of each technique with the indication for surgery~        -  To study inter-technique concordance with kappa coefficient~        -  To study the relationship between density differential between 2 acquisitions and grey~          level on subtraction, i.e. subtraction quality according to metal~   "
52927|NCT02874183|"~     To assess the effectiveness of pharmacist's provided education in HF patients, in improving~     patients' knowledge and self-efficacy, and to assess the impact of this intervention on the~     rate of hospital readmission and emergency visits at 30-days, 60-days and 90-days after~     discharge.~   "
52928|NCT02874170|"~     Drepanocytose disease is the first genetic disease in the world. It results in the synthesis~     of an abnormal hemoglobin (HbS), which in its deoxygenated form, polymerizes and leads to~     structural changes of red blood cells (RBC) which then take the shape of a sickle, become~     more fragile, more rigid and less deformable. The fragility of GR sickle causes their mass~     destruction, leading to chronic anemia (i.e. low levels of GR in the blood) associated with~     low tissue oxygenation. More rigid and less deformable, sickle GR tend to hang in the~     microvessels, leading to vaso-occlusive crises (CVO) particularly painful, can cause the~     failure of certain organs (spleen, kidneys, brain, lung, heart, liver , bone ...) and to~     life-threatening patients. Preliminary studies conducted on patients with drepanocytose~     disease (HbSS) have demonstrated changes of muscle tissue indicating a possible failure in~     the supply and use of oxygen. To date, the translation of this metabolic remodeling in the~     muscle work is not known.~      This project's main objective is to evaluate muscle function in drepanocytose attempted~     patients. We hypothesized that muscle remodeling associated with sickle cell disease have a~     functional impact on strength and muscle metabolism. The main objective is to characterize~     the maximal voluntary plantar flexor muscles. The criteria for these targets will be based on~     the comparison between healthy subjects, carriers of the sickle cell trait (HbAS) and sickle~     cell patients (HbSS) oxygen saturation.~      The strictly non-invasive approach proposed in this project will study the functional~     parameters of the muscle of sickle cell disease and the possible link with the clinical~     manifestations of the disease, including vaso-occlusive crisis, in which tissue oxygenation~     and pH plays a major role.~   "
52936|NCT02874066|"~     Hepatitis C virus (HCV) infection is common in patients receiving hemodialysis. The uptake of~     antiviral therapy for these patients is limited in the era of interferon (IFN) plus ribavirin~     (RBV), probably because the sustained virologic response (SVR) rates are low and the risk of~     treatment-related adverse events (AEs) are high. In the era of IFN-free direct acting~     antiviral agents (DAAs), several studies have indicated high rates of SVR and excellent~     safety profiles to treat patients with severe renal impairment. With regard to~     ombitasvir/paritaprevir/ritonavir plus dasabuvir (PrOD) treatment, a phase 2 study (RUBY-1)~     study has shown 90% of SVR in treatment-naive HCV-1 patients with chronic kidney disease~     (CKD) stage 4 or 5. Among the HCV-1b patients, who received PrOD for 12 weeks, all 7 patients~     achieved SVR. Although the data confirmed the excellent safety and efficacy in HCV-1b~     patients with severe renal impairment, the patient number was small and the data with regard~     to treatment-experienced patients was lacking. Therefore, we aimed to evaluated the safety~     and efficacy of ProD for 12 weeks in treatment-naive and treatment-experienced HCV-1b~     patients receiving hemodialysis.~   "
52929|NCT02874157|"~     Viral infections are only recently been investigated in patients on mechanical ventilation~     (MV) in ICU. It is especially the progress in the direct detection of these pathogens that~     allowed intensivists to try to assess objectively the impact of viruses in their patients.~     This is of course of viral infections Community (influenza virus, rhinovirus ...), but some~     viruses also occur under mechanical ventilation in immunocompetent adults. This is called~     viral infection nosocomial whose Herpesviridae are the most frequent and best studied. This~     replication Herpesviridae in ICU patients is usually a reactivation as primary infection.~     This reactivation is explained by the fact that after a few days of mechanical ventilation~     appears immunoparalysis, which can make the bed of bacterial or viral infection.Several~     studies have compared the pp65 antigenemia for quantitative PCR in immmunodéprimés patients.~     For example, in transplant patients (solid organs), the sensitivity of antigenemia was 91%,~     Quantitative PCR of 95.6% while the specificity was 57% and 81.6% respectively. No work,~     however, has to date compared these techniques in the intensive care patient. In a subject~     shortly epidemiological study, the sensitivity of the quantitative PCR performed on the LBA~     is 80%, when compared to antigenemia. Moreover this same study shows that half of the~     positive PCR on the BAL are not accompanied by a positive antigenemia, suggesting that PCR~     may be more sensitive than antigenemia. This exam has never been validated to date in~     intensive care. Finally, no work has so far evaluated the diagnostic performance of~     quantitative PCR performed on BAL~   "
52930|NCT02874144|"~     To evaluate the efficacy of an anti-inflammatory agent compared with placebo in relieving~     signs and symptoms of disease in patients with sinusitis.~   "
52931|NCT02874131|"~     This study is a randomized controlled trial comparing an integrated treatment, Behavioral~     Activation + Cognitive Processing Therapy (BA + CPT), to CPT alone among active-duty service~     members with posttraumatic stress disorder (PTSD) and comorbid major depressive disorder~     (MDD). Participants will complete assessor-administered and self-report measures at pre- and~     post-treatment assessments, as well as a 3-month follow-up. Additionally, participants will~     complete self-report measures of PTSD and MDD symptoms at each therapy session.~   "
52932|NCT02874118|"~     The frailty and frail elderly was defined in 2001 by Fried as a physiological state of~     heightened vulnerability to external shocks. 5 criteria for classifying the elderly in 3~     categories: frail, pre-frail and not frail. The prevalence of frailty in the general~     population was estimated to be 7%, 10% and 20% for over 65 years and 45% for over 85 years.~     This concept is explored in some chronic diseases, in order to prevent the loss of autonomy~     and tailor the treatment. In the carrier population of HIV, a North American retrospective~     study showed the frailty syndrome manifested as early as 10 years before, than in the general~     population. Furthermore various studies show in this specific population, increased incidence~     of diseases linked to age, suggesting an accelerated and premature aging.~      objectives: The objective of this study is to determine the prevalence of frailty defined~     Fried syndrome in a population of subjects aged 50 and over Holders of chronic HIV infection.~   "
52933|NCT02874105|"~     The rotator cuff tendinopathy is very common and associated with degenerative or traumatic~     changes of the rotator cuff and/or the sub-acromial bursa or the long head of the biceps.~     Lesions go of the simple tendinopathy without tear to the full-thickness tear of the cuff~     which means a loss of mobility or strength. The origin of this pathology remains~     controversial and many causes have been evoked (subacromial mechanical impingement,~     degenerative changes, muscle imbalance…). The clinical impairment is not always the same and~     varies from a painful shoulder with correct range of motion to a pseudoparalysis shoulder.~     The first treatment of the rotator cuff pathology is always non surgical and consists in~     relative resting, painkillers and/or non-steroidal anti-inflammatory drugs (NSAD) and~     physiotherapy. The aim of this management is to relieve pain and to restore the mobility and~     a good function of the shoulder.~      There is no consensus about the physiotherapy protocol for the treatment of the rotator cuff~     tendinopathy. In France, the most used physiotherapy protocol uses the strengthening of the~     muscles which stabilize the scapula (rhomboide muscles, trapezius and serratus anterior) and~     which lower the humerus (pectoralis major, latissimus dorsi and teres major). The aim of this~     approach is to augment the subacromial space in order to decrease the inflammation of the~     rotator cuff tendons and the associated pain. A technique of Dynamic Humeral Centering (DHC)~     uses a new method of glenohumeral centering in closed kinetic chain has been described (3C~     Concept for Centering in a Closed Chain). Dynamic humeral centring (DHC) is a modality of~     physiotherapy that aims to prevent subacromial impingement of rotator cuff tendons. In order~     to simplify and to improve its reliability, a special device called Scapuleo® has been~     developed. The aim of this device is to help the physiotherapist to realize simultaneously a~     subacromial decompression, a specific strengthening of the rotator cuff muscles and an~     optimal activation of the lower trapezius and the anterior serratus.~      Our hypothesis was that the DHC was not inferior to the conventional physiotherapy protocol~     for the medical treatment of the rotator cuff tendinopathy without full-thickness tear.~      We proposed a prospective and randomized study. All the patients treated in our department~     for simple tendinopathy of the rotator cuff or partial thickness tear were included in this~     study after signed consent. The physiotherapy protocol consists in 20 sessions of either~     Conventional program (Control group) or Dynamic Humeral Centering (Study group). The~     clinical evaluation included the range of motion measurement, Constant Score, Quick-DASH and~     Oxford Shoulder Score at 3 months and 6 months. Patients were blinded to the study~     hypothesis. The assessor of all outcomes was blinded to the interventions.~   "
52934|NCT02874092|"~     This is an open label study to assess the improvement in the Disease Activity Score for~     28-joint counts (DAS28) with ticagrelor given at 90 mg twice daily in patients with RA who~     have active disease despite MTX therapy (as defined by the inclusion/exclusion criteria).~     There will also be a cross sectional analysis of baseline platelet activity in subjects with~     rheumatoid arthritis and osteoarthritis. Subjects in the OA cohort will not receive any study~     medication, and will only have one study visit.~      Patients will receive 90 mg ticagrelor orally bid. The patients will receive drug for~     30-days. Methotrexate dose will remain stable throughout the study duration.~   "
52935|NCT02874079|"~     Autoimmune bullous dermatoses include pemphigus, bullous pemphigoid, pemphigoid gestationis,~     linear IgA dermatosis, mucous membrane pemphigoid, lichen planus pemphigoid, anti-p200~     pemphigoid, epidermolysis bullosa acquisita and dermatitis herpetiformis. Autoimmune bullous~     dermatoses are rare and have an incidence of 20-60 new cases per 1 million person- year in~     Europe. The incidence of the individual entities is slight significantly different within~     Europe, but strongly also in comparison to other countries such as Kuwait, Singapore, USA and~     South America. The most common of these disorders is the bullous pemphigoid.~      A considerable progress has been made in the last years to elucidate the pathogenic role of~     autoantibodies in these diseases. To this end, various in vitro and animal experiments have~     been used to understand some basic pathophysiological mechanisms in these diseases. Further~     studies are currently being carried out to explain a precise elucidation of the disease~     process and to be able to treat the patients targeted later.~      At present, however, no data are available to explain why certain individuals develop the~     autoimmune disease and others do not. Epidemiological studies showed some triggers to the~     development of autoimmune dysregulation, e.g. drugs.~      Furthermore, it has been shown that genetic factors play a role in the pathogenesis of the~     disease. A clear association with certain HLA regions have been shown in patients with~     pemphigus, e.g. about 95% of pemphigus patients from the group of Ashkenazi Jews have the~     HLA-DRB1*0402 haplotype. Recently, the first non-HLA gene associated with pemphigus was~     described. For other conditions such as bullous pemphigoid, pemphigoid gestationis or linear~     IgA dermatosis the association with HLA antigens is less pronounced. Another indication of~     the importance of the genetic background in these diseases can be elucidated from the~     observation of autoantibodies at a low concentration in healthy relatives of pemphigus~     patients.~   "
55111|NCT02845635|"~     The purpose of this study is to better characterize the fluctuations in multiple sclerosis~     symptoms and their relationship to medications, to length/extent of disease, and to a variety~     of physiologic measures.~   "
52937|NCT02874053|"~     Background:~      People with cancer often have to make complex decisions about their treatment. For some of~     these decisions, they have to weigh the benefits of a treatment against its side effects.~     They may have to think about its potential to increase the risk of another disease. One~     example is hormone replacement therapy. That reduces a woman s risk of getting colorectal~     cancer, but it raises her risk of getting breast cancer. Researchers want to learn more about~     how people make tradeoff decisions like these.~      Objective:~      To learn about how people respond to information about hypothetical health and medical~     treatment options.~      Eligibility:~      Adults ages 18 70.~      Design:~      Participants will have one 30-minute visit.~      Participants will complete a series of short questionnaires. These will be about their~     beliefs and values. Some may be about cancer and heart disease risk. Participants ages 18 to~     29 will answer questions about sexual health.~      Participants will write a paragraph or two about a room in their house or about a life event.~      Participants will read a series of stories. These will describe different hypothetical health~     treatments.~      The stories describe a pill that lowers the risk of one health condition, but raises the risk~     for another. After each story, participants will note how willing they are to take the pill.~      Participants will answer questions about the information that they got. They will also answer~     questions about their health, beliefs, and opinions.~      Participants will do 2 attention tasks computer.~   "
52938|NCT02874040|"~     Study the efficacy of endoresection of the tumor scar or, when surgery is not possible,~     transpupillary thermotherapy on the tumor scar to prevent neovascular glaucoma and secondary~     enucleation~   "
52939|NCT02874027|"~     Microbiome studies may be highlighted as crucial in the development of depression for TBI~     patients. The microbiota-gut-brain connection may further provide an opportunity for~     microbiota manipulation to treat the TBI patients with depression.This study is to~     investigate whether exist the relationship between depression and circadian rhythm of~     patients with TBI or not and focus the study on the potential of the host-microbiota~     interaction in regulating depression.~   "
52940|NCT02874014|"~     The study is to examine a moderate hypofractionation regimen of proton beam therapy for high~     risk or unfavorable intermediate risk prostate cancer. The prostate and seminal vesicles are~     treated with 6750 centigray (RBE) in 25 fractions (i.e. 270 centigray/fraction), while the~     regional pelvic nodes receive 4500 centigray (RBE) in 25 fractions (i.e. 180~     centigray/fraction) simultaneously. The overall treatment time is 5 weeks.~   "
52941|NCT02874001|"~     Validation of the PO-BADO in its short and long versions that need a standardized validation~     process with the inclusion of 450 Patients~   "
52942|NCT02873988|"~     Airway epithelium integrity is essential to maintain its role of mechanical and functional~     barrier. Recurrent epithelial injuries require a complex mechanism of repair to restore its~     integrity. In chronic obstructive pulmonary disease (COPD), an abnormal airway epithelial~     repair may participate in airway remodelling. The objective was to determine if airway~     epithelial wound repair of airway epithelium is abnormal in COPD.~   "
52943|NCT02873975|"~     This research study is studying a checkpoint kinase 1 (CHK1) inhibitor as a possible~     treatment for advanced solid tumors that harbor genetic alterations in the homologous repair~     (HR) pathway or with genetic alterations that indicate replication stress.~   "
52944|NCT02873962|"~     This research study is evaluating two drugs called Nivolumab and Bevacizumab as a possible~     treatment for relapsed Relapsed Ovarian, Fallopian Tube Or Peritoneal Cancer.~   "
52945|NCT02873949|"~     Etiopathology of periodontitis is complex and various risk factors are known :~        -  Bacterial factors: major risk factor. Although the presence of periodontopathogen~          bacteria is necessary for the onset of periodontitis, these microorganisms are not~          sufficient for progression of all periodontal disease.~        -  Immune factor: host immune response modulates the disease evolution to destruction or~          recovery. The most studied cytokine in periodontology is IL-1 that induces various~          immune reactions and bone resorption directly or indirectly through the stimulation of~          prostaglandin E2 (PGE2) release. PGE2 activates the matrix metalloproteinases that are~          responsible of the degradation of bone extracellular matrix.~      Cytokine production, especially TNFα, IL-1β, IL-6 and IL-8, by some immune cells is modulated~     by new identified molecules such as Triggering Receptor Expressed on Myeloid cells (TREM)~     whose role in periodontitis is unknown.~      The purpose of this study is to compare concentrations of soluble TREM-1 and TREM-2 markers~     in infected sites and in healthy sites in patients affected by periodontitis.~      Other purposes are~        1. Comparison of soluble TREM-1 and TREM-2 concentrations in healthy sites in patients~          affected by periodontitis and in healthy patients~        2. Comparison of soluble TREM-1 and TREM-2 concentrations before and after etiologic~          periodontitis treatment~        3. Estimation of the correlation between soluble TREM-1 and TREM-2 concentrations and~          clinical signs of periodontitis~        4. Description of soluble TREM-1/TREM-2 ratio before and after etiologic treatment~        5. Description of presence of some bacteria in sites analyzed for soluble TREM-1 and TREM-2~        6. Search for the most observed bacteria in presence of high concentrations of soluble~          TREM-1 and TREM-2 before and after etiologic treatment~        7. Evaluation of the impact of psychological stress measured through salivary cortisol~          level in saliva on TREM-1 and -2 expression~        8. Evaluation of the impact of psychological stress through stress and anxiety~          auto-questionnaires (Spielberger and Cohen) on soluble TREM-1 and TREM-2 concentrations~          in crevicular fluid of healthy and pathologic teeth.~   "
52946|NCT02873936|"~     The primary objective of this study is to evaluate the effects of filgotinib versus placebo~     in adults with active rheumatoid arthritis (RA) who have an inadequate response to biologic~     disease-modifying anti-rheumatic drug(s) (DMARDs) treatment.~   "
52947|NCT02873923|"~     The DATECAN-2 project aims at assessing the surrogate properties for OS of several~     time-to-event endpoints through meta-analyses of completed and published randomized~     controlled trials. Two main cancer localization are concerned: breast cancer and soft-tissue~     sarcomas. The impact of survival endpoints' definitions on the trials' results and~     conclusions will also be evaluated.~   "
52948|NCT02873910|"~     The purpose of this study is to evaluate the benefit and tolerability of IQP-AS-119 for~     reduction of susceptibility to infections and other complaints after extreme physical stress~     (participation in a marathon).~   "
52974|NCT02873572|"~     Addictions without substances are an emergent problem giving rise to a recent and increasing~     request of care. Among these new addictions, pathological gambling and pathological online~     video gaming which are up. The purpose of this study is to identify vulnerability factors~     (personality traits, decision making strategies...), which are common or specific to each~     type of game (on line poker, casino, MMORPG, and no-gamers).~   "
52975|NCT02873559|"~     In this scientific clinical investigation we will test whether testosterone and progressive~     resistance training can improve muscle strength and reduce the risk of falls in older men. In~     addition, we will examine whether this treatment improves quality of life, functional~     capacity, including sexual function and counteracts depression. Such a project have not been~     performed earlier.~   "
53170|NCT02870998|"~     This study aims to compare the impacts of two versions of a continuing education activity~     targeted at COPD case managers on educational outcomes: 1) participation; 2) satisfaction; 3)~     learning; 4) competence; 5) performance; 6) patient health outcomes.~   "
52949|NCT02873897|"~     In independent elderly people, the aim is to test recipes for different types of food from~     different countries (starter, main course with culinary aids, carrot purees, desserts and~     smoothies) likely to improve sensory acceptability of foods for elderly people who are~     dependent for their meals (persons for whom at least one meal per day is provided by a~     catering service - meals at home, old people's home). All of the recipes were developed~     thanks to the first two parts of the OPTIFEL project so as to take into account the needs of~     elderly people and recommendations in each country. The interest is to increase the sapidity/~     attractiveness of meals by optimizing sensory properties and the nutritional content of the~     foods, to meet the nutritional needs of this specific population with enriched recipes (with~     leguminous proteins and/or vitamins and minerals and/or fibre) suitable for different~     cultures. This ongoing research is being conducted on 2-4 different variants of each type of~     product: the starter (a soup of legumes), the main dish (diced chicken with culinary aids)~     and garnished (carrot puree), an apple-based dessert and fruit smoothies.~      For each product family, two products will be selected for each country: the preferred~     product (highest hedonic value of recipes enriched with leguminous proteins and/or vitamins~     and minerals) and the standard product without enrichment.~      Finally, at the end of this study, nine products will have been chosen: 2 soups, 2 culinary~     aids, 2 carrot purees, 2 desserts and 1 smoothie~   "
52950|NCT02873884|"~     The first aim of this study is to test the effect of the case management on the evolution of~     therapeutic alliance in patients with first episode psychosis in comparison with traditional~     nursing. The second aim is to test the effect of case management on nurses' well-being in~     comparison with traditional nursing. The third objective aims to show if therapeutic alliance~     is associated with insight in patients and with clinical and demographic data.~   "
52951|NCT02873871|"~     Randomized clinical trial to compare radial artery patency after transradial coronary~     catheterization using 2 different hemostasis techniques. Patients submitted to diagnostic or~     therapeutic coronary catheterization will be prospectively enrolled in this single-center~     trial and will be randomized to radial hemostasis with TerumoBand® or a standardized~     compressive dressing with gauze and elastic bandage.~   "
52952|NCT02873858|"~     Malnutrition is a frequent problem in persons older than 65 years: the prevalence of~     malnutrition can reach 25 to 29% in persons living at home who require help, figures vary~     between 19 and 38% for those living in institutions, and finally, the prevalence of~     malnutrition in hospitalized elderly patients can reach 30 to 90%. A few studies have~     attempted to explain modifications in attitudes, behaviour, the frequency of meals or~     nutritional status in the elderly by a fall in chemosensory sensitivity The aim of this~     project is to test the hypothesis that perhaps it is not as much the capacity to perceive a~     smell or a taste that affects eating behaviour in the elderly as their ability to distinguish~     between smells or tastes on the one hand (perceptual processing), and their ability to~     correctly interpret a chemosensory signal on the other (cognitive processing).~   "
52953|NCT02873845|"~     Altered quality of life in patients with stage III or IV colon cancer is well known. At their~     sides, their spouse/partner must also cope with the suffering caused by the disease and the~     upheavals that it engenders, with the treatments, in the organization of their everyday life.~     The physical, emotional, social and financial impact of cancer in general and its treatment~     on care-givers has already been studied. However, there are no data concerning the objective~     burden, that is to say the nature and the magnitude of the care weighing on the spouse of~     persons with colon cancer. Objective is to develop and validate a questionnaire that can be~     completed by the spouse/partner of patients with stage III or IV colon cancer so as to~     evaluate the burden of the disease in everyday life. It will allow medico‐social~     professionals to identify spouses/partners in difficulty and the needs of patients so as to~     offer the best support.~   "
52954|NCT02873832|"~     Heat-shock proteins (HSP) have been very highly conserved throughout the evolution of species~     and are characterized by their chaperone function, thanks to their ability to prevent~     aggregation and to promote the renaturation/break down of damaged proteins. Among other~     targets, they also chaperone JAK2, a key step that is deregulated in signalling in~     myeloproliferative syndromes (MPS) because of the JAK2V617F mutation. These HSP also have a~     potent cytoprotective action through their multiples inhibiting effects on apoptotic~     processes.~      Little is known about levels of HSP expression, in particular for HSP70 and HSP27, in MPS~     cells.~      However, in vitro studies of different cell models have shown the interest of HSP90~     inhibitors in slowing cell proliferation in MPS. These results have been confirmed in animal~     models with results in terms of blood counts and overall survival. In addition, it seems that~     the V617F mutated form of JAK2 is more sensitive than the wild-type to HSP90 inhibitors.~     Finally, inhibitors of HSP90 remain efficacious with regard to the inhibition of cell growth,~     even in cases of resistance to JAK2 inhibitors. Nonetheless, HSP90 inhibitors are known to~     stimulate the expression of other HSP, notably HSP27 and HSP70, which are, through their~     properties, tumorigenic and could lead to an escape phenomenon. Thus the combined use of~     several HSP inhibitors could be beneficial, and eventually present synergistic effects on the~     inhibition of tumour processes.~   "
52955|NCT02873819|"~     This is a multi-center, randomized, double-blind clinical trial to assess the safety and~     efficacy of GL-0817 as a means to prevent disease recurrence in patients considered at~     high-risk following surgery and adjuvant chemoradiotherapy.~   "
52956|NCT02873806|"~     The study objective was to evaluate the intraocular pressure (IOP) lowering effect of two~     iStent devices in eyes of subjects with primary open-angle glaucoma, washed out of two~     anti-glaucoma medications (one a Prostaglandin) prior to stent implantation.~   "
52976|NCT02873546|"~     The purpose of this study is to evaluate the effect of 10 sessions of anodal transcranial~     Direct Current Stimulation (tDCS - 1 mA) applied to left Cortex DorsoLateral PreFrontal~     (CDLPF) of Alzheimer's or Primary Progressive Aphasia (PPA) patients compared to the~     application of a placebo tDCS (sham procedure) on cognitive functions, which are evaluated at~     short term (1 week post-treatment) and mild term (3 weeks post-treatment).~      After unblinding, patients who received placebo treatment could be received active tDCS.~   "
52977|NCT02873533|"~     The analysis of this study will achieve an improvement in the management of patients over 70~     years with adaptation of chemotherapy regimens after analysis of the subject and its~     psychosocial environment.~      The analysis of socio-economic impacts will implement actions to optimize the care of the~     elderly while emphasizing the value of management / cost of care.~   "
52957|NCT02873793|"~     By analogy with the mouse, the activity of control pathways for transposable elements (TE) in~     foetal primordial germinal cells could prove to be a determinant for fertility in adulthood~     in humans. Moreover, defects in the control of transposable elements (TE) could also~     contribute to the aetiology of germinal testicular cancer, by inducing chromosomal~     instability and tumorigenesis. In this context, the aim is to analyse a specific type of~     adult germinal testicular cancers, seminomas. Directly related to our research interest, the~     histological, transcriptomic and epigenetic features of theses adult tumours are reminiscent~     of germinal cells normally present in foetuses. The investigator postulates that these~     similarities could also extend to the biology of transposable elements (TE), and in~     particular to the initiation of the control of these elements. The management of seminomas~     requires surgery, orchiectomy, which consists of the total excision of the affected~     testicles. Using high-resolution high-throughput sequencing techniques, we propose to analyse~     the control pathways of transposable elements (TE) in tumour samples harvested from surgical~     pieces in comparison with adjacent healthy tissue. The results obtained in these tumour~     samples will be compared with those in normal foetal gonad samples.~   "
52958|NCT02873780|"~     The aim of this study is to compare oxygen desaturation during two tests: the 6 minute walk~     test and the 3 minute step test, for COPD patients.~   "
52959|NCT02873767|"~     This study is designed to evaluate the safety and tolerability of single ascending doses of~     UCB4019 administered by subcutaneous injection in healthy subjects.~   "
52960|NCT02873754|"~     This project proposes to evaluate the feasibility, acceptability, and efficacy of a mobile~     intervention to target smoking-cessation and increase physical activity among low-income~     persons. The intervention is called Smoking Treatment and Exercise Program for Underserved~     Populations (STEP UP).~   "
52961|NCT02873741|"~     The purpose of this research is to study different strategies to identify women at highest~     risk for anal cancer. Primarily, investigators want to study a risk assessment called the~     Anal Cancer Risk Index; it gives women an overall number score based on risk factors that~     they may have for anal cancer, such as age, number of sexual partners, or smoking.~     Investigators seek to understand whether women with higher Anal Cancer Risk Index scores are~     more likely to have abnormal results on anal pap smears, HPV tests, or anal biopsies. The~     study team will collect swabs of the cervix and the anus to study different laboratory tests~     that could identify women at highest risk of cervical and anal cancer. These laboratory tests~     include an anal pap smear, tests for markers of disease and tests that detect the HPV types~     most likely to cause cancer. The study team would like to see which of these laboratory tests~     do the best job at predicting precancerous lesions in the anus and are better indicators of~     risk for cancer. After collecting these swabs, women will have a procedure called high~     resolution anoscopy where investigators look closely at the anus and biopsy any suspicious~     areas. Finally, the study team will look for HPV proteins and changes that HPV can make in~     cells to see if these tests predict anal lesions.~   "
52962|NCT02873728|"~     The goals of this series of studies is to test the effect of RIC on chronic leg ulcers~     (Diabetic ulcers and venous ulcers) - and to improve the understanding of its biological~     mechanism. This is a prospective, double-blind, randomized, shame procedure-controlled study.~   "
52963|NCT02873715|"~     This study is designed to translate an evidence-based family-based weight loss treatment for~     childhood obesity (FBT) into primary care settings using co-located interventionists to serve~     as a model for care delivered within a patient-centered medical home. FBT will be compared to~     usual care (UC), and the families will be followed for a 2 year period to assess between~     group differences in the targeted child and parent outcomes, weight changes in non-targeted~     siblings who are overweight/obese, parent and child changes in delay of gratification, and~     how these changes relate to weight loss, and the assessment of how provider attitudes predict~     their intention to use FBT in the future. The results of this study will inform future~     dissemination and implementation of FBT into primary care settings.~   "
52964|NCT02873702|"~     The purpose of this study is to determine the efficacy of dexlansoprazole compared to~     lansoprazole in healing erosive esophagitis (EE) in Chinese participants.~   "
52965|NCT02873689|"~     The purpose of this study is to determine the efficacy of dexlansoprazole compared to placebo~     in relief of daytime and nighttime heartburn over 4 weeks in Chinese participants with~     symptomatic non-erosive Gastroesophageal Reflux Disease (GERD).~   "
52966|NCT02873676|"~     The purposes of this study were to investigate the prevalence and risk factors for sarcopenia~     in Chinese adults and elderly, and evaluate the effect of Lifestyle Modification Project~     (LMP) on Clinical Outcomes, Quality of Life and Cost-effectiveness Ratio.~   "
52967|NCT02873663|"~     The investigators will test the validity of biomarkers for the detection of heavy alcohol use~     in patients with and without liver disease.~   "
52968|NCT02873650|"~     To characterize the pharmacokinetics and safety of dabrafenib following a single 100 mg oral~     dose in subjects with moderate and severe hepatic impairment.~   "
52969|NCT02873637|"~     The main objective of this study is to show that postoperative Total Knee Replacement (TKR),~     an analgesic perineural catheter in position under sartorial (KTSS) best preserves motor~     quadriceps femoral perineural catheter that (KTF) infused with even low doses of local~     anesthetics, this motor being evaluated by a semi quantitative simple clinical test locking~     of the knee feasible at the bedside.~      Patients will be randomized in two arms:~        -  catheter in position under sartorial (experimental group)~        -  femoral catheter (control group)~   "
52970|NCT02873624|"~     The aim of this study is to establish AKI incidence in patients who are undergoing~     laparoscopic cholecystectomy and to identify the potential risk factors associated with the~     development of AKI.~   "
52971|NCT02873611|"~     Estimation of the localization accuracy of the genicular ablation procedure applied for~     chronic pain suppression~   "
52972|NCT02873598|"~     This is a dose escalation trial to evaluate the safety of stereotactic body radiotherapy~     (SBRT) delivered in 3 fractions for patients with locally advanced pancreatic cancer (LAPC)~     who have received induction chemotherapy (FOLFIRINOX or gemcitabine and nab-paclitaxel).~   "
52973|NCT02873585|"~     A comparison of caries detection rates between conventional intraoral bitewing radiography~     and a stationary intraoral digital tomosynthesis (s-IOT) using a carbon nanotube X-ray source~     array. The secondary objective is to assess participants experience with the s-IOT device.~   "
52981|NCT02873481|"~     This is a pilot longitudinal mixed-methods study of pregnant women (n=20) who participate in~     CPC+Y at the VCU Health System Nelson Clinic or the Virginia Department of Health Richmond~     Health District's prenatal clinic (RHD) during their pregnancies. This pilot project will~     provide the necessary preliminary data to fuel an appropriately powered randomized controlled~     trial to evaluate the effects of CPC+Y in controlling weight gain, enhancing stress~     resilience, and improving maternal-child outcomes among overweight/obese diverse women.~     Because increasing physical activity has been found to have important mental health effects~     and maternal-child outcomes, it stands to reason that this innovative intervention has the~     potential to impact the way prenatal care is delivered in high risk populations.~   "
52982|NCT02873468|"~     The purpose of this study is to evaluate the efficacy of three doses of fluticasone~     propionate oral (viscous suspension) on changes of eosinophilic infiltration in esophageal~     biopsies.~   "
52983|NCT02873455|"~     Patient's anxiety prior to surgery has been linked to more harmful outcome after surgery. The~     investigators aim to evaluate the effect of video information on preoperative anxiety level~     in patients with colorectal cancer.~   "
52984|NCT02873442|"~     To evaluate the safety and effectiveness of cell therapy using precision cells Combined With~     TACE in Advanced Liver Cancer.~      Eligibility:~      Individuals greater than or equal to 18 years of age and less than or equal to 65 years of~     age who have been diagnosed with Advanced Liver Cancer.~   "
52985|NCT02873429|"~     This project focuses on whether nonspecific factors as well as patient characteristics~     contribute to treatment outcome differences. The project uses assessment instruments,~     computerized adaptive tests (CATs), from the Patient-Reported Outcomes Measurement~     Information System (PROMIS®). The research team has recently developed and tested (using~     PROMIS methods) a set of instruments to assess non-specific factors in healing from the~     patient's perspective. These instruments, the Healing Encounters and Attitudes Lists (HEAL)~     assess the Patient-Provider Connection, Treatment Expectancy, views of the Healthcare~     Environment, Positive and Negative Attitudes, Spirituality, and Attitude toward Complementary~     and Alternative Medicine (CAM). HEAL CAT's, like other PROMIS CATs, are brief, easy to use~     and understand, and are designed to apply to a broad spectrum of treatments and health~     conditions. In this project, the investigators aim to 1) evaluate whether HEAL predicts~     chronic pain treatment outcomes, 2) examine heterogeneity of treatment effects based upon~     HEAL and PROMIS scores in integrative and conventional medicine settings, and 3) interview~     patients and their clinicians regarding the utility of HEAL, PROMIS and a Pain Log for~     enhancing communication. The investigators will administer HEAL CATs and other PROMIS CATs~     (depression, anxiety, sleep disturbance, fatigue and physical function) to 200 patients who~     are starting treatment for chronic pain in integrative medicine and conventional medicine~     settings. Follow-up assessments will be completed 2 and 4 months after baseline testing. The~     investigators will evaluate factors that may predict which patients judge themselves to be~     improved, the same, or worsened. Some of the possible factors that may contribute to~     improvement include HEAL scores, emotional distress, or the preference for CAM or~     conventional treatment. The investigators are also interested in learning whether patients~     find the assessments to be clear and useful. A subset of 50 patients and approximately 10~     clinicians will complete interviews about the HEAL and PROMIS questions, and about the Pain~     Log developed by a patient advocacy group partner, the American Chronic Pain Association. By~     interviewing patients and their healthcare providers, the investigators hope to determine the~     clarity and acceptability of the HEAL and other assessments, and to learn whether HEAL and~     PROMIS summaries enhance patient-provider communication in the clinical partnership.~   "
52986|NCT02873416|"~     To evaluate the safety and effectiveness of cell therapy using Precision Cell Immunotherapy~     to treat Advanced Lung Cancer.~      Eligibility:~      Individuals greater than or equal to 18 years of age and less than or equal to 65 years of~     age who have been diagnosed with Advanced Lung Cancer.~   "
52987|NCT02873403|"~     Around 250 millions of people in the world (3.8%) have knee osteoarthritis (KOA). Due to~     aging and increasing obesity, the prevalence of KOA is expected to increase in the developed~     country in the next 20 years. KOA decreases quality of life of patients through chronic pain,~     joint stiffness, and reduced social activity, which influence emotional wellness as well. KOA~     has also impact on the biomechanics of the lower limbs, leading or amplifying the~     tibiofemoral misalignment and an increase of the medial knee joint loading. Increase of the~     medial knee joint loading may lead patients into a vicious circle by increasing knee pain,~     decreasing activities, increasing weight and disease progression. Knee brace is a~     non-pharmacological treatment recommended for KOA. It aims to reduce misalignment of the~     limb. However, the main issue is the poor compliance because of lack of effectiveness, more~     drawbacks than benefits, discomfort, bad fitting, migration of the brace, bulkiness,~     aesthetic, skin irritation, blisters and too much pressure on the knee. By its freedom in~     design, 3D printing may resolve most of these complaints.~      This study aims to compare clinical and biomechanical effectiveness, comfort and patients~     complaints of a knee brace made by 3D printing to a conventional knee brace.~      The institute for Applied Health Research of Glasgow Caledonian University (GCU) will lead~     the experimental trial. They will recruit men or women (40 to 70 years old) suffering from~     medial KOA in Glasgow area. Participants will be in study for 10 weeks. During this period,~     they will wear 2 different knee braces for two weeks each with a 1-week period without knee~     brace between. Participants will have five visits to GCU: once for leg measurement to make~     knee braces and four times to fill questionnaires and perform gait analysis. Besides, they~     will wear activity monitor for 3 non-consecutive weeks.~   "
52988|NCT02873390|"~     To evaluate the safety and effectiveness of cell therapy using herinCAR-PD1 cells to treat~     advanced cancer.~      Individuals greater than or equal to 18 years of age and less than or equal to 70 years of~     age who have been diagnosed with relapsed or refractory cancer that has not responded to or~     has relapsed after standard treatment.~   "
52989|NCT02873377|"~     Construction workers have the highest rate of smoking among all occupations, and are~     frequently exposed to a wide range of workplace hazards (e.g. toxins), which interact with~     smoking to increase their health risks. Minority construction workers, in particular, have~     higher smoking and lower cessation rates compared to other groups, and they generally show~     lower access and participation in cessation and health promotion services. The number of~     Hispanic workers employed in the construction industry in the US has tripled in the past~     decade to 2.6 million (23% of all construction workers). This study will develop, administer,~     and evaluate a novel smoking cessation program in a hard-to-reach and underserved population~     of Hispanic male construction workers using using pilot cluster randomized clinical trial~     (RCT) to test the developed intervention for feasibility and potential efficacy.~   "
52990|NCT02873364|"~     Chronic spontaneous urticaria is an inflammatory disease which is characterized with~     intermittent or daily urticaria. This diseases lasts for more than 6 weeks. Several recent~     studies have suggested a role for vitamin D in modulation of immune system and pathogenesis~     of chronic urticaria.~   "
52991|NCT02873351|"~     From 3 large patient databases, patients diagnosed with AMD who have never taken~     levodopa(L-DOPA) containing medications have a mean age of diagnosis at 71 years. Patients~     who have been treated with L-DOPA containing medications have a mean age of diagnosis of AMD~     at 79 years.~      L-DOPA binds to GPR143 in the retinal pigment epithelium, and releases PEDF, which protects~     the retina and downregulates VEGF, which is the cause of neovascularization.~      The Investigators will evaluate the safety and tolerability of carbidopa-levodopa in patients~     with AMD, and measure the effects on surrogate functional biomarkers of AMD.~   "
93605|NCT02341911|"~     Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Carboplatin in Triple Negative Breast~     Cancer (TNBC)~   "
52992|NCT02873338|"~     The purpose of this study is to determine whether CX-01 when given together with standard~     induction and consolidation therapy for acute myeloid leukemia (AML) will increase the~     effectiveness of the induction/consolidation therapy. Two different doses of CX-01 will be~     studied and safety and tolerability will be assessed.~   "
52993|NCT02873325|"~     DESIGN:~      Disease registry - non-interventional.~      INDICATION: Patients failing first or subsequent line treatment for adenovirus and / or~     cytomegalovirus reactivation post allogeneic hematopoietic stem cell transplantation.~   "
52994|NCT02873312|"~     Approximately 15 Study Sites will participate over total 24 months. Study population will~     consist of adults age 22 or over, reporting overactive bladder (OAB) symptoms for at least 3~     months.~      Primary Study Objectives:~        1. To assess efficacy of the StimRouter stimulation in improving OAB symptoms of urgency~          and frequency as measured by Patient Voiding Diary when targeting the posterior tibial~          nerve~        2. To assess safety of the StimRouter therapy for the indication of OAB~      Secondary Study Objective:~      To evaluate efficacy of the StimRouter therapy in addressing urinary urge incontinence as~     measured by the Patient Voiding Diary~      Study Design is prospective, multi-center, randomized, double-blinded~      Primary Endpoint:~      The primary efficacy endpoint will be the difference between the investigational and control~     groups in proportion of responders, where Responder is defined as having ≥50% improvement in~     average voiding frequency above the normal value of 8 (those returning to normal voiding~     based on 7-day average voids/leak episodes < 9, will be categorized as achieving half or more~     reduction) AND having ≥50% improvement in average number of moderate to severe urgency~     episodes, at approximately three months after programming.~      Secondary Endpoint:~      Secondary endpoint will be the difference between the investigational and control groups in~     proportion of patients with reduction by half or more in urinary urge incontinence as~     measured by the average number of urge incontinence episodes per day.~   "
52995|NCT02873299|"~     The purpose of this study is to compare two slightly different methods of transcranial~     magnetic stimulation (TMS) to treat Post Traumatic Stress Disorder (PTSD)~   "
52996|NCT02873286|"~     A total of 400 subjects will be recruited into five treatment subject groups à 80~     subjects.Subject will receive two administrations 4 weeks apart which will consist of~     MVA-BN-RSV Dose 1, MVA-BN-RSV Dose 2 or Placebo (TBS).~   "
52997|NCT02873273|"~     The purpose of this study is to determine whether a longer duration, controlled, sustained~     release dexamethasone delivery system would be more effective in helping patients with~     osteoarthritis reduce their pain, remain functional, and delay their need for knee~     replacement.~   "
52998|NCT02873260|"~     This study will evaluate the ability of a single dose of the live attenuated recombinant~     tetravalent dengue vaccine TetraVax-DV-TV005 (referred to as TV005) to protect against~     infection with rDEN3Δ30, an attenuated DENV-3, when administered 6 months after the TV005~     vaccine.~   "
52999|NCT02873247|"~     Patients who test Helicobacter pylori positive, are treated with antibiotics. However, due to~     a number of factors (such as unknown treatment compliance, no standardized follow-up, ...), a~     relative low eradication-percentage was reported.~      Therefore, the investigators want to measure the anticipated improvement in~     eradication-percentage due to the standardized treatment schedules (1st line, 2nd line and~     further) and the optimized communication with the general practitioner and patients.~   "
53000|NCT02873234|"~     Chinese Medicine syndrome differentiation has been a prevalent therapy in China for thousands~     of years. It is based on patients' symptoms, pulse, tongue and coating on the tongue.~     Therefore, the syndrome of patients and corresponding Traditional Chinese Medicine (TCM) may~     vary.~      This multicenter prospective cohort studies the efficiency and safety of TCM compared with~     antidepressants. A total number of 4600 cases with primary depression are expected to be~     collected and divided into 3 cohorts based on the patients' requirement and choices. Patients~     in one group will receive TCM, and patients in the other two groups will respectively receive~     antidepressants only and integrated treatment of TCM and antidepressants. This study has 2~     phases: treating period and the follow-up.~      The main purpose of this long-term study is to evaluate the efficiency of TCM compared with~     antidepressants in reducing relapse and suicide rate, changing lifestyle, improving patient~     compliance as well as the safety.~   "
53001|NCT02873221|"~     This study will evaluate the long-term safety and tolerability of intermittent treatment with~     ubrogepant for the acute treatment of migraine over 1 year.~   "
53002|NCT02873208|"~     The primary objective of this study is to evaluate the long-term safety and tolerability of~     ALKS 3831 in subjects with schizophrenia.~   "
53003|NCT02873195|"~     This randomized phase II trial studies how well atezolizumab and capecitabine with or without~     bevacizumab work in treating patients with colorectal cancer that is not responding to~     treatment and has spread to other places. Monoclonal antibodies, such as atezolizumab and~     bevacizumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in~     chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Giving atezolizumab with capecitabine and bevacizumab may be a better way in~     treating colorectal cancer.~   "
53004|NCT02873182|"~     A safety and feasibility study of free-run and stimulated corporal electromyography (EMG) to~     assess autonomic neural function during spinal and/or pelvic surgery in women and men.~   "
53005|NCT02873169|"~     Determination of risk factors of ventricular arrhythmias (VAs) after implantation of~     continuous flow left ventricular assist device in order to characterize which patient~     requires ICD implantation in primary prevention.~   "
53006|NCT02873156|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and~     pharmacokinetics (PK) of multiple ascending oral doses of E2027 in healthy participants.~   "
53007|NCT02873143|"~     The prevalence of adolescent knee pain is 33%, and patellofemoral pain (PFP) is the most~     common diagnosis with a nontraumatic onset. The 5-year prognosis of adolescent PFP compared~     with other types of knee pain is unknown.~      In 2011, a cohort of 2200 adolescents aged 15 to 19 years answered an online questionnaire on~     musculoskeletal pain. Of these, 504 reported knee pain, and 153 of these were clinically~     diagnosed with PFP. Now, after 5 years, the 504 adolescents, as well as 252 randomly selected~     adolescents who did not report knee pain in 2011, will be contacted again to gain insights~     into their prognosis.~   "
53008|NCT02873130|"~     Voice disorders in teachers have a significant impact on communication, quality of life, and~     economic costs to the healthcare system. We need to advance the prevention of voice disorders~     in teachers by testing an online telepractice model with synchronous (in real-time) and~     asynchronous (stored and accessed later) methods. The current study will investigate the~     effectiveness of the theoretically-driven Global Voice Prevention Model (GVPM) delivered by~     two methods; 1) online telepractice (synchronous and asynchronous) and 2) traditional,~     in-person for vocally healthy physical education and vocal music student teachers.~     Effectiveness of the model will be assessed by voice-related measures captured daily on a~     smartphone app during student teaching, matching the asynchronous aspects of the telepractice~     model and representing the effects of vocal loading from teaching.~   "
53009|NCT02873117|"~     This is a multicenter, cohort study based on medico-administrative data from pathology~     laboratory registries and drug reimbursement files (CNAM-TS).~   "
53010|NCT02873104|"~     To evaluate the safety and efficacy of the Cutera truSculpt radiofrequency device for~     circumferential reduction.~   "
53011|NCT02873091|"~     Sixteen million babies were born in 2010, approximately half were by cesarean. Labor~     analgesia should be the first choice for these parturients based on the consideration of~     security and humanization. However this labor analgesia rate is quite low in China (<5%)~     while in western country, this rate is up to 60%. Programmed intermittent epidural bolus~     (PIEB) is the latest technique for labor analgesia which has less neurotoxicity theoretically~     compared with Continuous Epidural Infusion(CEI) with Patient controlled epidural analgesia~     (PCEA) which is used most commonly. In that study, they reported less total local anesthetic~     consumption, fewer manual bolus doses and greater patient satisfaction with the PIEB~     technique. In China, multiple factors contribute to the reasons of low labor analgesia rate.~     From the patient's point of view, worrying about unsatisfied analgesia, and not adapted to~     the symptoms of motor block, such as inability to move their legs distressing, both are~     important reasons of refusing labor analgesia and preferring to cesarean delivery. Therefore,~     in this clinical trial, we plan to find a safer and more effective regimen for labor~     analgesia in Chineseparturients. This clinical trial is designed to prove PIEB used~     Ropivacaine is safer and more effective than CEI for labor analgesia in Chinese parturients.~   "
53012|NCT02873078|"~     This randomized controlled study aims to evaluate the efficacy of exposure-based~     Internet-delivered cognitive behavior therapy for children 8-12 years with Functional~     Abdominal Pain Disorders. The children participate along with their parents, who will also~     receive specific modules with information on how to support their children in the treatment.~     Predictors and mediators for treatment effects will be studied as well as the cost~     effectiveness of the intervention.~   "
53013|NCT02873065|"~     This study compared efficacy and safety of Ilaprazole based triple regimen therapy including~     Ilaprazole 5mg, Clarithromycin 500mg and Amoxicillin Cap(Amoxicillin) 1000mg BID on the first~     line eradication treatment of H.pylori~   "
53014|NCT02873052|"~     The MyoVista system is a novel electrocardiogram technology that provides non‐invasive~     assessment of myocardial abnormalities by analyzing energy changes at the cellular level of~     the myocardium.~   "
53015|NCT02873039|"~     Over the past decade, advancements in therapies available for pulmonary hypertension (PH)~     have increased life expectancy for those who qualify and receive treatment. Yet,~     prognostication of these patients has remained a clinical dilemma. The application of the~     REVEAL registry predictive algorithm provides information about estimated 1-year survival but~     since invasive measurements from a right heart catheterization cannot easily be repeated, it~     is not feasible to continually use this longitudinally to assess the disease burden. Simple~     tests such as BNP has been shown to be very clinically relevant in short -term and long term~     prognostication and seems to correspond well to the right ventricular failure. Elevated right~     atrial pressures, and its estimation via IVC measurements predict poor survivorship in a~     recent retrospective analysis. As clinical measurement of jugular venous pressure is becoming~     less reliable, we aim to bring point- of-care ultrasound to the outpatient setting. Point of~     care ultrasound is widely used in the Emergency Department and Intensive Care Unit settings.~     By measuring estimated right atrial pressure (eRAP) via Inferior Vena Cava (IVC) measurements~     at outpatient clinic visits we aim to find a correlation with the existing and widely used~     B-type Natriuretic Peptide (BNP), that is collected at each visit as a part of regular care.~     These measurements can be followed longitudinally and may aid in prognostication. Data will~     be collected over the period of 1 year at clinic visits. A composite endpoint (including~     death, hospitalizations for PH, addition of new PH specific therapy after a stabilization~     period of 3 months, lung transplant or atrial septostomy) will separately be collected. At~     the end of the data collection period, clinical data only will be collected for a additional~     2 years via phone correspondence, chart review or at regular PH clinic visits.~   "
53016|NCT02873026|"~     Eye trauma is a leading cause of blindness and visual impairment. Penetrating injuries of the~     eye are more likely to result in poor vision and the main cause of this is a scarring~     response on the retina (proliferative vitreoretinopathy, PVR) The purpose of this study is to~     investigate the potential of an anti-inflammatory treatment (triamcinolone acetonide) to~     improve the outcome of surgery in eyes that have suffered severe trauma.There is good~     evidence from laboratory studies that additional steroid treatment into and around the eye at~     the time of surgery could reduce scarring by reducing inflammation and improve visual~     outcomes.~   "
53017|NCT02873013|"~     This study will target patients who have received a histopathological diagnosis of prostate~     cancer and who are undergoing treatment in various forms, including active PSA surveillance,~     surgical treatment, radiotherapy, endocrine therapy, and chemotherapy. The study will survey~     information about the patient at time of diagnosis, clinical staging, details of initial~     treatment, status of disease progression, and prognosis at the end point of the study. The~     purpose of the study is to clarify distribution of staging, the actual status of treatment~     choices and treatment outcomes.~   "
53018|NCT02873000|"~     To evaluate the use of Incentive Spirometry in Non-critically Ill Hospitalized Patients With~     Shortness of Breath.~   "
53019|NCT02872987|"~     The GMALL registry serves the purpose of ALL research and quality assurance. The Registry~     collects data about diagnostics, treatment and outcome of Adult ALL Patients in the clinical~     routine, whether or not the patient is treated within a clinical trial.~   "
53043|NCT02872662|"~     This study aims to develop highly sensitive methods for early detection of relapse based on~     the patients unique mutations. Initially, a mutational screen is being performed. Primers~     directed against these mutations will be constructed and presence of mutations will be~     followed in bone marrow and blood frequently after transplantation.~   "
56011|NCT02833857|"~     This is a multicenter, open-label study to evaluate the safety and pharmacokinetics in~     pediatric subjects with secondary hyperparathyroidism receiving a single dose of AMG 416 at~     the end of hemodialysis.~   "
53020|NCT02872974|"~     MySweetHeart Cohort is an observational study to assess the effect of gestational diabetes~     mellitus (GDM) on early life offspring's cardiovascular health.~      The primary objective is to assess the effect of GDM on the surrogate markers of~     cardiovascular disease (CVD) at birth (left ventricular mass index and subclinical~     atherosclerosis). The secondary objective is to assess the effect of GDM on the~     cardiovascular structure and function during the fetal period and neonatal adverse~     cardiovascular risk factors.~      The main hypothesis is that offspring of women with GDM have a larger LVMI and a larger cIMT~     at birth (primary outcomes) compared with offspring of women without GDM. Further, other~     hypotheses are that offspring of women with GDM have more foetal cardiovascular alterations~     and adverse neonatal cardio-metabolic risk factors (secondary outcomes) compared with~     offspring of women without GDM.~      My SweetHeart Cohort is linked to MySweetHeart Trial, a randomized controlled trial assessing~     the effect of a multidimensional interdisciplinary lifestyle and psychosocial intervention to~     improve the cardio-metabolic and mental health of women with GDM and their offspring. The~     principal investigators of this trial are Prof Jardena Puder and Dr Antje Horsch from~     Lausanne University Hospital.~   "
53021|NCT02872961|"~     PURPOSE: This study will evaluate the relationships between small intestinal bacterial~     overgrowth (SIBO), immune activation, inflammation, and symptoms in pediatric abdominal~     pain-related functional gastrointestinal disorders (FGIDs), i.e., irritable bowel syndrome~     (IBS), functional dyspepsia (FD), & functional abdominal pain (FAP), to better understand the~     role of SIBO in their pathogenesis. DESIGN & PROCEDURES: Cross-sectional study. Subjects:~     Patients followed at the UT-Houston Pediatric GI clinic, aged 4-17 years, undergoing~     endoscopic evaluation of abdominal pain, meeting Rome III diagnostic criteria for IBS, FD, or~     FAP, without evidence of an organic etiology of abdominal pain upon routine laboratory,~     radiologic, endoscopic, histologic evaluation. Sample Size: At least 30 patients, ≥ 15 with~     SIBO (i.e., positive small bowel aspirate culture and/or glucose breath hydrogen test), and~     ≥15 without SIBO. Sample Materials: Small bowel biopsies and aspirates, serum, breath~     samples, symptom questionnaire responses. Measures: 1) Immune activation & inflammation -~     measured by serum cytokine levels & small intestinal tissue inflammatory cell infiltration &~     cytokine levels. 2) Symptoms - measured by Abdominal Pain Index, Wong-Baker FACES™ Pain~     Rating Scale, Questionnaire on Pediatric Gastrointestinal Symptoms - Rome III Version. 3)~     Small bowel microbiota analysis - assessed by 454 pyrosequencing. RISKS & POTENTIAL BENEFITS:~     Aside from the risks associated with routine endoscopy with biopsies, which would occur even~     without study enrollment, the risks associated with serum collection, one extra biopsy~     specimen collection, small bowel aspirate collection, completion of pain scales/~     questionnaires, and the glucose breath hydrogen test for the purposes of the study are~     minimal. POTENTIAL IMPACT: This study should yield valuable information regarding the~     relationships between SIBO, immune activation, inflammation, and symptoms in pediatric IBS,~     FD, and FAP. Potential biomarkers to support the diagnosis of these FGIDs and novel targets~     for therapy, such as immune molecules and previously unrecognized bacterial phylotypes and~     species possibly contributing to disease pathogenesis, may be identified. Also, determining~     the reliability of the glucose breath hydrogen test vs. small bowel aspirate culture in the~     diagnosis of SIBO in this setting may enable the physician to avoid invasive and costly~     procedures in the diagnostic work-up of children with these FGIDs.~   "
53022|NCT02872948|"~     The main objective of this study is to estimate the intrinsic diagnostic qualities of the~     digital dPCR in the screening of T21 from a multicentrique sample of patients with~     pregnancies at high risk of T21 (risk > 1/250).~      The profit expected from this technique is to propose to the encircled women a screening more~     successful than that of the screening combined(organized) of the 1st quarter, simple of~     realization and in a moderate cost. We thus propose here an original alternative(alternate)~     method to the exclusive, expensive and binding techniques of top-debit(-flow). The recent~     technical improvements and his(her,its) advantages medical - economic allow to envisage a~     reliable, strong and long-lasting use of the dPCR in clinical routine in the DPNI of T21 in~     most of the laboratories. This pilot project could serve for the later development of a study~     of clinical validation multicentrique of large scale(big turntable ladder).~   "
53023|NCT02872935|"~     In parturients undergoing Cesarean section under spinal anesthesia, co-loading of 1 liter of~     crystalloids, with placing the spinal, along with administering a phenylephrine infusion and~     glycopyrrolate, enables placing a spinal with minimal perioperative nausea and vomiting and~     good intra and post-operative pain relief.~   "
53024|NCT02872922|"~     Endothelium is a cell layer that interposes blood and smooth muscle of vessels. This~     biological sensor reacts to physical and chemical stimuli by synthesis and/or liberation of~     regulatory substances like nitric oxide (NO), which acts on vascular tone, growth of muscle~     cells and platelet aggregation and leukocyte. Clinically, endothelial function measured by~     technique flow-mediated dilation (FMD) is a strong predictor of cardiovascular events and~     all-cause mortality. Previo study demonstrated that continuous and pulsed therapeutic 1-MHz~     ultrasound waveforms improved endothelial function in health volunteers and this vasodilation~     persisted for 20 min, which provided them with anti-inflammatory vascular effects. In~     subjects with type 2 diabetes (DM2) the chronical hyperglycemia and dyslipidemia reduce NO~     bioavailability causing endothelial dysfunction. Low intensity therapeutic ultrasound is an~     electrotherapeutic instrument employed in musculoskeletal injuries that promotes~     endothelium-dependent vasodilation, and its mechanism of action has not been studied on DM2.~     The aim of our study is evaluate endothelial function of patients with DM2 after different~     waveforms (placebo, continuous and pulsed) of therapeutic ultrasound. Therapeutic ultrasound~     is a electrotherapeutic instrument that can changes arterial endothelial function of subjects~     with DM2 because of NO bioavailability increasing, which implies anti-inflammatory and~     vasodilatory beneficial alterations for diabetic patients.~   "
53025|NCT02872909|"~     This study aims to examine whether the pain of topical photodynamic therapy (PDT) is~     significantly different when using low irradiance ambulatory light emitting diode (LED)~     devices compared with conventional higher irradiance hospital based LED light sources when~     used for superficial non-melanoma skin cancer. The investigators are also investigating the~     phototoxicity and efficacy of each regime in this randomized assessor-blinded clinical trial.~   "
53044|NCT02872649|"~     Patients with severe heart failure supported by left ventricular assist device (LVAD) require~     adequate long-term anticoagulant therapy. New oral anticoagulants such as the direct thrombin~     inhibitor dabigatran may represent an alternative to Coumarin for long-term anticoagulation.~      In this pilot single-center study, thirty LVAD patients with stable renal function were~     scheduled to receive phenprocoumon or dabigatran for long-term anticoagulation after~     implantation of a HeartWare HVAD system following an open-label balanced parallel group~     design.~   "
53045|NCT02872636|"~     The objective of this feasibility study is to demonstrate the safety and feasibility of using~     an investigational extracorporeal system and catheter to filter hemorrhagic cerebrospinal~     fluid (CSF) post subarachnoid hemorrhage (SAH) treatment, and reintroduce the CSF via the~     same catheter.~   "
69250|NCT02660528|"~     This proposed study sets out to examine the antidepressant effects of tocilizumab among~     patients with treatment-refractory major depression.~   "
53026|NCT02872896|"~     Subjects will first have a blood pressure reading recorded on both arms using a non-invasive~     blood pressure monitoring (NIBP) cuff in the preoperative area. Then blood pressure will be~     recorded using the ClearSight monitor on each hand over a one-minute period. If mean arterial~     pressure (MAP) as assessed by either the noninvasive blood pressure (NIBP) monitoring cuff or~     the ClearSight system differs by more than 10% from arm to arm, the subject will be excluded~     from the study.~      Before induction of anesthesia, the subject will be randomized to either:~      ClearSight group + usual clinical care: Information from ClearSight monitor will be available~     to the clinicians. According to ASA guidelines, usual blood pressure monitoring includes~     non-invasive blood pressure measurements every 5 minutes during a surgical case.~      Non-ClearSight group (blinded) + usual clinical care: Information from ClearSight monitor~     will not be available to the clinicians.~      Both patient groups will have continuous ClearSight monitoring and non-invasive blood~     pressure monitoring every 5 minutes. The difference will be in the intervention group data~     from the monitor will be available to the clinicians in the operating room, but in the~     control group data from the ClearSight monitor will not be available (blinded) to the~     clinicians. Regardless of the study group assignment, second-by-second ClearSight monitor~     continuous blood pressure data will be recorded for each study patient and will be used for~     analysis.~      The morning of post-operative day 3 the subject will be given the QoR-15 questionnaire and~     will complete POMS morbidity surveys.~   "
53027|NCT02872883|"~     This is a pilot study that will eventually result in a main randomised controlled trial that~     will look at what management is associated with a higher rate of normal birth and a lower~     rate of chorioamnionitis (maternal infection) when women break their waters but labour does~     not start. Spontaneous rupture of the membranes (when the waters break) at term (37-42 weeks~     gestation) is a physiological event that happens during labour. However, according to Gunn et~     al. (1970) in 8-10 % of the cases the membranes rupture before labour starts. The time~     between the rupture and the onset of labour is called latent phase and time wise is variable.~      Studies have showed no statistically significant differences in terms of neonatal infection~     or chorioamnionitis when the investigators induce labour with prostaglandins compared to when~     labour starts spontaneously (Hannah et al 1996). Seaward et al. (1997) noted a number of~     confounding factors that might relate to the incidence of chorioamnionitis (maternal~     infection), the strongest predictor was having more than 8 vaginal examinations since the~     rupture of membranes and before delivery which was a stronger predictor than the duration of~     the latent phase. It is thought that by reducing the number of internal examinations,~     chorioamnionitis may be reduced, and hence neonatal infection may also be reduced. The main~     RCT will compare clinical outcomes and maternal satisfaction when women consent to be~     randomized to four groups: (1) Active management and routine internal examinations during~     labour, (2) Active management and reduced internal examinations, (3) Expectant management and~     routine internal examinations, (4) Expectant management and reduced internal examinations.~      This application seeks ethics approval for the pilot phase to ensure that a definitive study~     can be undertaken appropriately. It is important to test that all the components work well~     individually and as a whole, to estimate sample size and ultimately to test the integrity of~     the research protocol before embarking on the main trial.~   "
53028|NCT02872870|"~     This study will help to better characterize oral and written language disorders and determine~     if these disorders are continuous or not. The participants ( dyslexic and dysphasic patients~     and control adults) will carry out an auditory lexical decision task during which an~     electroencephalogram (EEG) will be recorded.~   "
53029|NCT02872857|"~     The purpose of this study is to examine the effects of the study drug--Galantamine—on~     patients with subarachnoid hemorrhage (SAH). The study will examine how patients with SAH~     will tolerate the study drug and how it may improve brain functioning in patients after SAH.~   "
53030|NCT02872831|"~     The primary objective of this proposed prospective randomized, multi-center study is to~     evaluate the capability of the new 22G SharkCore™ needle to obtain tissue specimens and to~     compare its performance against the standard 22G BNX Endoscopic Ultrasound Fine needle~     aspiration (Beacon Endoscopic, Newton, MA) needle in the evaluation of solid mass lesions in~     the pancreas and gastrointestinal tract. The secondary objective is to determine the ability~     of the 22G SharkCore™ needle system to yield histologic tissue.~   "
53031|NCT02872818|"~     The purpose of the study is to determine apoptotic signaling pathways such as Survivin,~     Bcl-2, Bax, c-Myc and caspase-9 expression levels in rats model with iatrogenic endometrial~     hyperplasia after metformin and medroxyprogesterone acetate administration.~   "
53032|NCT02872805|"~     One of the distinct challenges faced by emerging adults with HIV is the transition of their~     care from their long-term pediatric HIV provider to treatment within an adult HIV program.~     The consequences of an unsuccessful transition can range from difficult to catastrophic. The~     Adolescent to Adult Patient-centered HIV Transition (ADAPT) Study is a randomized trial of~     innovative interventions targeting gaps in care that are major drivers of loss in the ART~     continuum of care cascade among adolescents and increasing missed opportunities to engage~     adolescents into care. The specific aims of ADAPT are: 1. To inform strategies for transition~     services in resource-limited settings; 2. To examine the developmental, clinical, and other~     factors that predict a successful transition; and, 3. To gain fundamental insight on~     implementation barriers among African adolescents through the application of the ego-network~     defined social support that will inform targets for structured intervention. ADAPT will be~     conducted in central, southern, and northern Nigeria at selected PEPFAR sites supported by~     the Institute of Human Virology, Nigeria. To address Aim 1 the investigators will conduct six~     focus groups including: Adolescent patients, parents and health care providers. To address~     aim 2, the investigators will conduct a cluster randomized clinical trial. The two~     interventions are based on prior evidence-informed engagement strategies: 1) educational~     interventions and 2) interventions that use a peer transition advocate who prepares the~     adolescent and their parents for transition. The investigators will enroll 300 patients (150~     patients in each arm). The sites will be randomized to an intervention. The primary outcome~     will be successful transition, keeping two follow-up appointments within a nine months period~     following transition. Secondary outcomes, as recommended by focus group participants will~     also be measured. To examine the potential role of social network components and~     characteristics of both egos and alters on primary outcomes, a Generalized Estimating~     Equation (GEE) approach will be used to explore the associations between primary outcomes and~     factors at the ego, alter, and network levels. The finding from this study will guide~     institution of best practices for transitioning adolescents in Nigeria and other countries~     lower and middle income countries with similar challenges and potential for high impact.~   "
53033|NCT02872792|"~     Cycloergometer is a validated method for different care. This kind of device allow passive~     and active care for patient. The interest of cycloergometer for patient hospitalized in~     Intensive Care Unit for Sepsis has never been demonstrated.~      The main objective of this study is to determine the impact of early mobilization by~     cyclo-ergometer in association with standard physiotherapy, on the ICU length in patients~     with septic shock~      The secondary objectives of this study are to assess the impact of early mobilization by~     cyclo-ergometer in association with standard physiotherapy on:~        1. the duration between hemodynamic stability* and the removal of sedation~        2. the duration between the removal of sedation and ICU discharge~        3. the mechanical ventilation duration (invasive and noninvasive)~   "
53076|NCT02872233|"~     Evaluation of the effectiveness of a sunscreen product by determining its Sun Protection~     Factor (SPF) on the skin of human subjects.~   "
53286|NCT02869464|"~     The purpose of this study is to examine the percentage of patients who present with abdominal~     aortic aneurysms (AAA) will also have intracranial aneurysms (IA) and conversely; to examine~     the percentage of patients who present with intracranial aneurysms will also have abdominal~     aortic aneurysms.~   "
53034|NCT02872779|"~     The chemotherapy monitoring is currently based on radiological (RECIST 1.1 guideline) and~     clinical evaluation every 3 months. Circulating markers as Carcino Embryonic Antigen (CEA),~     circulating tumour DNA and total cell free DNA represent an alternative approach to evaluate~     the response. In the field of metastatic colorectal cancer (mCRC) recent studies suggest that~     early evaluation could be clinically relevant. Indeed, early tumoral response seems to be~     correlated to overall survival. Moreover, post-operative morbidity increases with the number~     of prior chemotherapy treatments. Early evaluation could allow to modify chemotherapy~     regimens when response appears to be insufficient.~      The aim of the present study is to evaluate, in a prospective cohort of patients treated with~     systemic IV chemotherapy (5 Fluorouracil +/- oxaliplatin +/- irinotecan) +/- targeted therapy~     as first line treatment for a mCRC, the correlation between early variations of circulating~     tumour markers including CEA, circulating tumour DNA and total cell free DNA, and the 3~     months objective response as defined in the RECIST 1.1 guideline.~   "
53035|NCT02872766|"~     43 Subjects (43 eyes) qualified for participation will undergo the required screening~     procedures to determine study eligibility. The surgical protocol involves applying riboflavin~     0,22% to 0,25 % up to 20 minutes . Then, the eyes will be exposed to UVA (ultraviolet A)~     light with the KXL II system according to the programmed treatment pattern.~      All use of the KXL II system will be in accordance with the general instructions in the~     operator's manual. All subjects will be evaluated at screening, Day 3, and 1, 3, 6 ,12 and 24~     months after treatment.~      Manual keratometry, manifest refraction, uncorrected visual acuity, best corrected visual~     acuity, slit lamp biomicroscopy, pentacam measurements and placido disc topography (TMS),~     will be obtained at baseline and at appropriate times after the treatment.~   "
53036|NCT02872753|"~     The aim of the present double blind controlled study is to evaluate the effects in terms of~     pain control and functional recovery provided by a single intra-operative injection of ACP~     performed at the end of arthroscopic partial meniscectomy.~      Patients included in this trial will be randomized in two treatment groups: the first one~     will receive a single injection of 3-5 cc of ACP (using a dedicated centrifuge) at the end of~     the arthroscopic meniscectomy, whereas the second group will be treated by surgery alone. In~     order to ensure the double blinding of the trial all the patients enrolled will undergo blood~     harvesting before anesthesia, and acp will be produced just for the patients included in ACP~     group.~      All patients will be evaluated basally, and then at 15, 30, 60, and 180 days after surgery by~     the following evaluation tools: IKDC (International Knee Documentation Committee) subjective,~     VAS (Visual Analogue Score) for pain, EQ-VAS for general Health Status, KOOS (Knee Injury and~     Osteoarthritis Outcome Score) and Tegner score. Furthermore, during the basal evaluation and~     at each follow-up visit up to 2 months, active and passive Range of Motion (ROM) of both the~     operated and contralateral knee were documented; also in addition, the trans-patellar~     circumference of both knees was registered to assess the trend of knee swelling over time.~      Drugs assumption during the follow-up period will be recorded for each patient. All eventual~     adverse events occurred during the follow-up period will be registered.~   "
53037|NCT02872740|"~     Title: Embolization of Gastric Arterial Supply for Weight Loss~      Sample size:~      10 patients~      Study Population: Morbidly obese patients who were seen by the bariatric surgery program at~     Toronto Western Hospital but are either not interested or not eligible for surgery.~      Study Design:~      Single center, randomized, prospective, non-blinded pilot study.~      Study Duration:~      12 months (November 2015 - December 2015).~      Agent:~      150-250 micron polyvinyl alcohol particles~      Primary objective:~      To further evaluate the safety of embolization of the left gastric and gastroepiploic~     arteries. To determine if either or both will result in significant weight loss and decrease~     in waist circumference among obese patients.~      Primary objective measure:~      The number of adverse events in a 1 year period will be recorded. The weight change from~     baseline will be recorded.~   "
53038|NCT02872727|"~     The object of this new project is to proceed with investigations with the employees of the~     cohort for the first study so as to obtain a remote evolution (5 years) of their respiratory~     function while measuring their nanoparticle exposure. This will enable us to assess the~     possible link between exposure and respiratory function evolution in the employees~   "
53039|NCT02872714|"~     The purpose of this study is to evaluate the overall response rate (ORR) of INCB054828 as a~     monotherapy in the treatment of metastatic or surgically unresectable urothelial carcinoma~     harboring FGF/FGFR alterations.~   "
53040|NCT02872701|"~     This is a phase 2, multi-center, single dose, open-label, exploratory study in suspected lung~     cancer patients scheduled to undergo endoscopic or thoracic surgery per CT/positron emission~     tomography imaging based on standard of care. This study aims to assess the efficacy of OTL38~     and Near Infrared Imaging (NIR) at identifying pulmonary nodules within the operating~     theater, and to assess the safety and tolerability of single intravenous doses of OTL38.~   "
53041|NCT02872688|"~     The purpose of this study is to investigate the effect of a GanedenBC30, a probiotic bacteria~     (Bacillus coagulans strain GBI-30, 6086), on the gut microbiome in healthy adults. Subjects~     will complete a 2-week run-in period prior to receiving GanedenBC30. The study is open-label~     and subjects will act as their own controls as the microbiome is unique to individuals.~     During the run-in period, subjects will collect two stool samples and complete daily bowel~     habit diaries in order to understand usual habits and profile the microbiome for each~     subject. 30 subjects will take part in this research study conducted at Nutrasource~     Diagnostics Inc. Subjects will take GanedenBC30 for four weeks. Stool samples will be~     collected at the end of the study and daily bowel habit diaries maintained for the duration~     of the study.~   "
53042|NCT02872675|"~     The current study aims to explore the role of prebiotic supplementation in adults with and~     without Asthma/Exercise-Induced Bronchoconstriction (A/EIB). All participants will be asked~     to consume a prebiotic supplement, and a placebo, each for a total duration of four weeks,~     separated by a two-week wash out period. The investigators hypothesise that improvements in~     pulmonary function observed in adults with Asthma following prebiotic supplementation. We~     hypothesise that improvements in pulmonary function will be attributed, at least in part, to~     gut microbiota mediated improvements in human immune function.~   "
53287|NCT02869451|"~     The purpose of this pilot project is to pilot-test a combined cannabis and smoking cessation~     treatment. The intervention combines mobile technology with behavioral strategies,~     counseling, and medications.~   "
53046|NCT02872623|"~     Early diagnosis of tumors of the small intestine is a challenge for clinicians and for~     radiologists. The detection of tumors of the small intestine is a field in which the video~     capsule endoscopy has the lowest performance.~      The entero-CT with enteroclysis is the imaging technique used primarily to explore patients~     with a strong suspicion of small intestine tumors. However the entero-CT with enteroclysis~     has disadvantages : it is irradiating, the nasojejunal tube implies a discomfort to the~     patient and it is a complicated examination in terms of logistics with necessity of specific~     equipment to insert the nasojejunal tube.~      MRI has been proposed as an alternative imaging technique and satisfactory results have been~     reported with the MRI enteroclysis. However, this technique has several disadvantages related~     to nasojejunal tube insertion and the necessity of equipment compatible with the high~     magnetic fields. The enterography-MRI without enteroclysis, whose principle is to distend the~     small intestine by ingestion of large quantities of a liquid, has a major and undisputed role~     in the exploration of Crohn's disease of the small bowel. However, its capacity for~     distension of the small intestine for optimal tumor detection is questioned and its role in~     tumor detection is largely unknown.~   "
53047|NCT02872610|"~     The objective of the SOS-trial is to examine if an online self-help intervention is effective~     in reducing suicidal thoughts among people at risk of suicide. The SOS-trial is a randomized,~     wait-list controlled trial with 1:1 allocation ratio. A total of 438 people with suicidal~     thoughts will be allocated to the intervention condition (N=219) or the control condition~     (N=219). The intervention condition consists of a six-week internet-based self-help therapy~     intervention. The control condition consists of a waiting list assignment for 32 weeks. The~     primary hypothesis is that the intervention is superior to the control condition in reducing~     suicidal thoughts at post-test (6 weeks). The SOS-trial is a partial replication of a~     previously conducted Dutch trial.~   "
53048|NCT02872597|"~     This study is a Phase I study to investigate the addition of inhaled Ipratropium bromide to~     standard therapy in the treatment of severe asthma attacks in children admitted to the~     Pediatric Intensive Care Unit. Half of the subjects will receive inhaled Ipratropium, and~     half will receive an inhaled placebo.~   "
53049|NCT02872584|"~     Free fatty acid index will be measured in patients before and 1 month after high dose~     prednisone.~   "
53050|NCT02872571|"~     The liver may not be an optimal site for islet transplantation due to obstacles by an instant~     blood-mediated inflammatory response, and low revascularization of transplanted islets.~     Therefore, intramuscular islet transplantation offers an attractive alternative, based on its~     simplicity, enabling easier access for noninvasive graft imaging and cell explantation.~   "
53051|NCT02872558|"~     This study will evaluate the efficacy of shared decision making in treatment of Acute Otitis~     Media in the Emergency Department setting.~   "
53052|NCT02872545|"~     The purpose is to compare percentages of myocardial segments showing attenuation in patients~     in forward tilted position (biker position) or 2 conventional positions (dorsal decubitus or~     semi sitting) at acquisition with D-SPECT camera in myocardial tomoscintigraphy.~      The hypothesis is that the percentage of myocardial segments with attenuation is~     significantly lower when acquisitions are made in forward tilted position (biker position).~      The secondary purpose is to restrict this analysis to 3 cardiac regions most subject to~     attenuation artifacts (anterior, apical and inferobasal regions).~   "
53053|NCT02872532|"~     This protocol is being designed to offer testicular tissue cryopreservation to male pediatric~     patients (0-17 years of age) with fertility threatening medical diagnoses or facing surgery,~     chemotherapy or radiation therapy that may cause loss of reproductive potential.~   "
53054|NCT02872519|"~     This clinical trial studies positron emission tomography (PET) imaging utilizing 18F-FSPG~     [(S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid], a glutamic acid derivative, to image patients~     with ovarian cancer before undergoing surgery or transplant. Diagnostic procedures, such as~     18F-FSPG PET, may help find and diagnose ovarian cancer and find out how far the disease has~     spread.~   "
53055|NCT02872506|"~     Compare the quality of life at 6 months between 2 populations of patients followed for~     terminal ileitis of Crohn's disease treated with anti-TNF or ileocecal resection.~   "
53056|NCT02872493|"~     The purpose of this study is to determine whether or not the total length of small intestine~     effects outcomes after bariatric surgery in a cohort of patients preoperatively and up to ten~     years postoperatively. Roux-en-Y gastric bypass and vertical sleeve gastrectomy will be the~     surgical groups in this study. We aim to determine if bowel length has a significant effect~     on long term weight loss or other nutritional deficiencies in this bariatric cohort.~   "
53057|NCT02872480|"~     Healthy (non-injured) and concussed college-aged participants will complete two testing~     sessions that include (1) clinical symptom, balance, and cognitive evaluations and (2) a~     progressive exercise session to establish symptom exacerbation or maximal exercise capacity.~     Individuals randomized to the control group will receive no intervention between sessions,~     while individuals randomized to the intervention group will complete 30 minutes of stationary~     bike exercise at least 3 days/week.~   "
53058|NCT02872467|"~     The purpose of this research is to study the effects of nasal oxytocin administration on~     maternal behaviors that may be influenced by cocaine use during pregnancy. 32 mothers with~     prenatal use of cocaine during the current pregnancy will be studied at 3-6 months~     postpartum, when they will complete 3 study visits, a 2-week double-blind trial of twice~     daily nasal spray (oxytocin or placebo) and 4 telephone interviews. All information collected~     is confidential.~   "
53077|NCT02872220|"~     The primary objective of this tudy was to evaluate the potential of photoallergy of of sun~     care products Sun Protection Factor (SPF) 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104~     application compared to that of a negative control (0.9% sodium chloride, NaCl) and followed~     by irradiation with UV A and UVB.~      The secondary objective aims for evaluation of the safety of SPF 50 Y65 110, SPF 50 Y51 002,~     and SPF 15 V27 104 combined with ultraviolet (UV) A/B irradiation by monitoring adverse~     events (AEs) throughout the study.~   "
53078|NCT02872207|"~     The objective of this study was to compare the human eye stinging potential of experimental~     formulas and an industry standard shampoo mixture. The study was conducted under the~     supervision of a Board Certified Ophthalmologist.~   "
56578|NCT02826421|"~     The purpose of this study is to compare corneal incision size after IOL implantation with the~     use of one of four IOL delivery systems (three preloaded IOL delivery systems and one~     manually loaded IOL delivery system).~   "
53059|NCT02872454|"~     Major depression is the leading cause of disability in the United States and is a major~     contributor to suicide, a leading cause of premature death. The majority of individuals with~     depression do not receive adequate pharmacologic or psychotherapeutic treatment due to~     difficulty accessing services or stopping treatment due to side effects, non-response, or the~     stigma associated with attending mental health clinic visits. Mobile health information~     technology services, such as text messaging, have the potential to provide effective~     self-management support for depression to nearly every adult in the US with depression.~     Guided self-help via text messaging has been shown to be effective for improving a range of~     health behaviors as well as symptoms of depression. However, previously studied depression~     text messaging services have not utilized the breadth of psychotherapeutic techniques shown~     to be effective for depression nor have they attempted to tailor the psychotherapeutic~     content to the individual in order to improve acceptability and outcomes. Advanced artificial~     intelligence methods (e.g., reinforcement learning) offers the capability to weed out~     ineffective messages and to target messages to individuals in order to substantially improve~     program effectiveness. This pilot study is the first step in towards developing an~     artificially intelligent text message service for depression.~      The specific aims of the study are to: 1) demonstrate the feasibility of recruiting and~     enrolling participants from the general population of US adults and delivering a~     text-messaging intervention for depression, 2) determine whether there are differences in the~     perceived helpfulness of messages derived from different psychotherapeutic treatment~     modalities, and whether these differences are moderated by participant characteristics (e.g.,~     age, gender, depression symptom severity), 3) determine whether messages derived from~     different psychotherapeutic treatment modalities or their perceived helpfulness are~     associated with changes in depression symptoms, and whether these relationships are moderated~     by participant characteristics.~   "
53060|NCT02872441|"~     IgG4-related disease (IgG4-RD) is a recently identified rare disease characterized by~     inflammatory lesions with polyclonal lymphoplasmocytic infiltrate, with IgG4+ plasma cells~     predominance, and fibrosis in involved tissues. Despite a preferential involvement of~     exocrine organs, virtually all tissues can be affected by the disease. Corticosteroids are~     usually effective in this indication, but with poor tolerance and a high risk of relapse~     after decrease or withdrawal of this treatment. In this context, identification of new~     therapeutic targets is a major concern for these patients. Physiopathology of IgG4-RD remains~     actually unknown. In previous studies, it has been shown that T follicular Helper (Tfh) cells~     are expanded in the blood of these patients. Tfh cells have an important role in the~     formation of germinal centers (GCs), and ectopic GCs have been found in tissues of patients~     with IgG4-RD. Tfh cells have a major role in proliferation and differentiation of B cell~     compartment. In this context, this population could have an important contribution in the~     pathophysiology of IgG4-RD and could represent a therapeutic target in this disease.~      TIFOLH4 study intend to analyze tissue Tfh cells in patients with IgG4-RD at diagnosis. This~     study is an exploratory prospective multicentric study. Thirty patients with a suspected~     diagnosis of IgG4-RD, because of 1 or more suggestive organ involved, will be included in the~     study. A 50 mL blood sample and a biopsy, obtained in the same time of the diagnostic biopsy~     sample, will be obtained in this study. The results obtained in patients with a confirmed~     diagnosis of IgG4-RD ( IgG4-RD group ) will be compared to results of patients with another~     diagnosis ( control group ). Main objective of the study is to show by confocal microscopy~     an expansion of the number of Tfh cells (CD3+CD4+PD1+ cells) in tissue of IgG4-RD patients~     compared to controls. Secondary objectives include : tissue analysis of Tfh subsets (Tfh1,~     Tfh2 and Tfh17) ; tissue analysis of B regulatory cells, T regulatory cells, and T helper~     cells (Th1, Th2, Th17); correlation between tissue and circulating biomarkers; tissue~     proteomic analysis; and functional analysis of circulating Tfh cells after sorting of these~     cells and co-culture tests with autologous naive B cells. All these results will be compared~     between the  IgG4-RD group  and the  control group . This study should clarify the role~     of these Tfh populations in IgG4-RD, identify diagnostic tissue and blood biomarkers, and~     identify therapeutic targets in these patients.~   "
53061|NCT02872428|"~     THIS IS THE SECOND PART OF A 2-PART STUDY. The purpose of the first part of this study was to~     determine the safety and tolerability of ascending doses of valproic acid (also known as~     Depacon) administered as intravenous infusion (IV) in doses ranging from 15 mg/kg to 250~     mg/kg in healthy subjects.~      ID: VPA-C-002~      The second part of the study will also be to determine the safety and tolerability of single~     ascending doses of valproic acid administered as IV in trauma subjects with hemorrhagic~     shock.~   "
53062|NCT02872415|"~     Numerous experimental and clinical studies have shown that preterm neonates are particularly~     sensitive to stress. Preterm neonates routinely undergo painful invasive procedures. Each~     situation causing pain or discomfort can alter their development and cause short term~     cardiovascular consequences but also have long-term neurocognitive influences. Repetitive~     procedural pain can also lead to changes in the pain sensitivity threshold therefore. The~     most common painful procedures are lancing for blood glucose testing. In adults, infants and~     term newborns, forearm blood glucose testing has been demonstrated to be less painful than~     conventional sites (heel, fingers). But data is lacking in preterm neonates.~      The primary purpose of this study is to demonstrate a significant reduction in pain response~     during forearm blood lancing vs conventional sites (fingers, heel) in preterm neonates born~     up to 32 weeks gestation.~      This study is an interventional multicenter (3 centers), randomized, double bind trial with a~     cross over assignment. 60 premature neonates born between 23 to 32 weeks.~      Gestation with a postnatal age less than 72 hours that will undergo at least 3 blood glucose~     pricks will be included. The different sites will be randomly successively tested.~   "
53063|NCT02872402|"~     The goal of the study is to investigate the effect of a lifestyle intervention program~     (adoption of exclusive breastfeeding, healthy diet and regular physical activity) on~     minimizing postpartum weight retention among women with recent GDM.~   "
53064|NCT02872389|"~     The purpose of this clinical trial is to compare hypnotic effect of sevoflurane and~     desflurane at equal minimum alveolar concentrations using power spectral analysis of the~     electroencephalogram.~   "
53065|NCT02872376|"~     Anemia is the most common extraintestinal manifestation of IBD, occurring in 6 to 74 percent~     of patients. Most cases of anemia in IBD are due to iron deficiency (IDA) and to anemia of~     inflammation (AI). Although the ECCO diagnostic criteria for IDA are simple, and iron~     supplementation represents a cheap and usually effective treatment, many IBD patients with~     IDA are not properly treated. The inconsistent adherence, by many physicians, to treatment~     guidelines for IDA in IBD is often motivated by the belief that mild to moderate degrees of~     anemia may not have a significant impact on the patient's quality of life or do not represent~     the main clinical problem of the patient, that oral iron supplementation may adversely affect~     disease activity, and that parenteral iron administration may cause severe side effects. On~     this basis, we aim to perform a longitudinal, prospective, observational study whose main~     objective is the determination of the prevalence of anemia in IBD patients in Italy.~     Secondary objectives of the study are a) to investigate the pathogenesis of anemia in IBD,~     with a particular focus on the differential diagnosis between IDA and AI, and how disease~     activity, extension or behavior influence the relative frequency of IDA and AI; b) to verify~     the adherence to ECCO guidelines for the treatment of IDA in IBD (the proportion of patients~     with IDA that receive adequate iron supplementation); c) to administer dedicated~     questionnaires to the patients in order to measure the influence of anemia on fatigue and~     quality of life among IBD patients.~   "
53079|NCT02872194|"~     The objective of this study was to compare the human eye stinging potential of experimental~     formulas and an industry standard shampoo mixture. The study was conducted under the~     supervision of a Board Certified Ophthalmologist. The study design was a three cell, single~     blind study. Subjects were given the industry standard shampoo mixture in one eye and an~     exploratory sunscreen in the other as according to the randomization schedule.~   "
96070|NCT02309671|"~     This trial investigates the effects of several doses of FE 999049 in Japanese women~     undergoing IVF/ICSI treatment.~   "
53066|NCT02872363|"~     Breast screening is a service offered by the NHS to help detect breast cancer and~     precancerous changes early at a time when treatment is more likely to be curative. An~     effective service must reach the 'at risk' but asymptomatic population. Breast screening~     uptake in London, consistently falls below the national target and is well below the national~     average. Uptake in West London is particularly low, with boroughs in Inner North West London~     having the some of lowest uptake rates in the country.~      Routine text message reminders have proven effective at improving uptake of breast screening~     appointments. However little attention is paid to the content of the messages. Previous~     studies of text message reminders in other clinical areas have shown that the content of~     these messages matters and some text messages are more effective than others.~      This protocol describes the design of a randomized controlled trial to investigate the effect~     of differently worded text messages on the engagement with breast screening in West London.~      Two intervention arms were designed taking into consideration results of a 1000 woman survey~     to highlight the behavioural barriers that most predict attendance. The survey tested 15~     behavioural constructs and the two that most strongly predicted history of attendance were~     used to inform the text message content of the intervention arms for this trial.~      To this end, this randomised controlled trial (RCT) will test the current standard practice~     text message reminder against two intervention text message trial arms informed by the above~     described survey.~      The setting is West of London Breast Screening Service and women aged 47-73 who are due for~     screening will be randomized to receive one of the three trial arms.~      The primary outcome is the difference in uptake between trial arms. Further statistical~     analysis will analyse the difference in uptake by age group, deprivation score and previous~     attendance status.~      Result will inform how small changes to the word content may have significant effects on~     attendance at screening mammogram appointments.~   "
53067|NCT02872350|"~     Enterocolitis necrotizing (ECUN) is a common and serious gastrointestinal disease in~     premature infants.~      The diagnosis of ECUN based on clinical and radiological criteria. The abdomen plain film to~     date is the reference examination to confirm or refute the diagnosis. Indeed, the presence of~     pathognomonic signs (pneumatosis, aéroportie) on the abdomen of cliché can confirm the~     diagnosis. The prognostic value of these radiographic findings is currently controversial.~      Abdominal ultrasound is a test whose possibilities in diagnostic and prognostic term began to~     be considered for some years. It also has other advantages, including that of not being a~     radiating examination. Studies on the prognostic value of abdominal ultrasound are rather~     few. Moreover, they involve a series of heterogeneous patients in terms of gestational age.~     Or the pathophysiology of ECUN in children born at term and in children born prematurely is~     not the same.~      The objective is to study prospectively the prognostic contribution of abdominal ultrasound~     in the ECUN in premature under 33SA.~   "
53068|NCT02872337|"~     The purpose of this study was to evaluate the efficacy of a one-time, preoperative physical~     therapy protocol on postoperative (1) discharge disposition, (2) pain, function and stiffness~     and (3) patient satisfaction.~   "
53069|NCT02872324|"~     Mindfulness is both a natural resource of individuals present in all individuals in varying~     degrees characteristic ability of attention to the experience that unfolds moment by moment~     without judgment and a practice based on meditation, mindfulness exercises, which aims to~     enhance two central skills of mindfulness that are the presence and acceptanc. In the context~     of recurrent depression, the practice of mindfulness meditation in the frame of MBCT is~     recognized as effective in psychological suffering and relapse. The mechanisms implied in~     MBCT efficacy are emotional but especially cognitive. Among the cognitive mechanisms,~     reduction of rumination is a major factor in the action of MBCT, especially for patients with~     less than three depressive relapses.~      This exploratory research focuses on the impact of mindfulness functioning (mindfulness~     resource level at baseline) on the benefits of MBCT for patients with recurrent depressive~     disorder.~      The objective is to assess whether the level of mindfulness resource of patients with~     recurrent depression is a factor contributing to the positive effect of a MBCT applied in~     add-on to conventional care.~      This objective will be measured by comparing the clinical improvement of patients secondary~     to MBCT according to the initial categorization of the mindfulness resource.~      Clinical improvement will be more important for patients characterized by a lower initial~     level of mindfulness resource.~   "
53070|NCT02872311|"~     This is an open-label, randomized trial in up to 210 adults aged 65-74 years to evaluate the~     immune response to consecutive influenza vaccination across 2 seasons. Participants will be~     randomized to receive 1 of 3 licensed and recommended vaccines in the first year; 2 arms will~     receive the same vaccination in the second year and the third arm will be randomized again to~     1 of 3 licensed vaccines. All participants will have pre and post-vaccination serum blood~     draws for a total of 6 draws over 18 months.~   "
53071|NCT02872298|"~     Prospective, multicenter, single-arm (non-randomized) study of Targeted Lung Denervation~     (TLD) Therapy in subjects with severe asthma.~   "
53072|NCT02872285|"~     The objective of this Phase 2 trial is to determine the efficacy and safety of LYC-30937-EC~     in patients with moderate plaque-type psoriasis.~   "
53073|NCT02872272|"~     The loss of skin barrier function after burn causes increased susceptibility to infections,~     which are the leading cause of morbidity and mortality in burn patients. Topical antibiotics~     are one part of the therapeutic arsenal available to treat these infections. Pseudomonas~     aeruginosa and Staphylococcus aureus are the two major colonizing agents found in this~     population of patients.~      The use of dressings impregnated with amikacin is a common practice. Actually, there are no~     available data on local and systemic effects with this antibiotic. The study of tissue and~     plasma pharmacokinetics of amikacin is therefore very important to secure and optimize this~     singular use of amikacin and improve the care of burn patients.~      The objective of the study is to describe the plasma and tissue pharmacokinetics of amikacin~     after dermal administration and impregnated dressing to estimate the pharmacokinetic~     parameters and their variability in a burned population.~      Secondary objectives are to assess on the one hand the relationship between the effectiveness~     of treatment and the concentration of antibiotic at the site of tissue infection, and on the~     other hand to assess the relationship between plasma concentration and the toxicity found of~     this treatment. We would like also to note the efficacy of the antibiotic treatment in terms~     of: need for repeat surgery (new skin graft), healing time and hospital length of stay.~      Blood samples and skin biopsies will be made for each patient to day 3 and day 7 after the~     start of treatment.~      The knowledge about the tissue concentrations obtained and a possible systemic absorption~     will then provide additional safety data and optimize the conditions of use of these~     dressings (dosage, frequency of administration) for effective treatment and safe.~   "
53074|NCT02872259|"~     The purpose of the study is to assess the safety and efficacy of BGB324 given together with~     standard treatment, pembrolizumab or dabrafenib and trametinib, compared to standard~     treatment alone,~   "
53075|NCT02872246|"~     Evaluation of the effectiveness of a sunscreen product by determining its Sun Protection~     Factor (SPF) on the skin of human subjects.~   "
53080|NCT02872181|"~     During Cesarean Delivery pregnant women are frequently tilted to the left 15 degress to~     reduce compression of the major blood vessels by the uterus. Despite this common practice,~     there is no conclusive evidence to support this practice. In fact it may even be deleterious~     to have women positioned in this position. The aim of the study is to determine whether or~     not tilting women to the left during cesarean section (CS) is helpful or detrimental. The~     authors hypothesize that left uterine displacement of 15 degrees, which is commonly employed,~     is useless for preventing compression of these blood vessels. To investigate this question,~     women will be randomly assigned to either be tilted 15 degrees to the left during CS or~     positioned flat on the table. Fetal acid base status, vasopressor/phenylephrine use, patient~     satisfaction, maternal complications, and fetal complications will all be collected and~     compared.~   "
53081|NCT02872168|"~     Recent in-vitro and in-vivo studies performed by one of the investigators (ESO, ICMPE, UPEC,~     France) have recently allowed to synthetize a new and easy-to-synthesized chemical compound~     of the furosemide (pyridinium furosemide) during furosemide degradation by electro-Fenton or~     bioconversion. The biological properties of pyridinium furosemide are currently under~     investigation. Furosemide is a diuretics currently used in the treatment of patients with~     heart failure. The goal of the investigators is to assay pyridinium furosemide in urine of~     patients treated by furosemide to demonstrate that pyridinium is or not a metabolite of~     furosemide in humans. This study will contribute to assess the fate of pharmaceutical~     residues of furosemide in the environment.~   "
53082|NCT02872155|"~     This study evaluates if oral hydratation is as effective as endovenous hydratation in the~     prophylaxis of contrast-induced nephropathy in patients renal insufficiency grade III under~     study conducting contrasted computed tomography.~   "
53083|NCT02872142|"~     This is a pilot, phase 2, prospective, open-label, single-arm study to evaluate disease~     progression, forced vital capacity, and the safety and tolerability of plasma exchange (PE)~     using Albutein® 5% in subjects with amyotrophic lateral sclerosis (ALS).~   "
53084|NCT02872129|"~     A 12-year follow-up of 166 women with fibromyalgia (FM) or chronic widespread pain (CWP) in~     western Sweden.~      The 166 women participated in a Randomised Controlled Trial called GAU in 2004-2005, aiming~     to investigate the effect of pool exercise and patient education.~      The primary aim of the present study is to examine the change of symptoms after 11-12 years~     in 166 women with FM or CWP and also investigate predictors of change of symptoms and work~     ability.~      The 166 women will be asked to participate in the present follow-up study. The follow-up~     examination comprises a standardised interview of symptoms and demographic variables, a~     battery of self-administered questionnaires and tests of physical function.~   "
53085|NCT02872116|"~     The main purpose of this study is to compare how long patients with gastric or~     gastroesophageal junction cancer live after receiving nivolumab and ipilimumab or nivolumab~     and chemotherapy compared with patients receiving chemotherapy alone.~   "
53086|NCT02872103|"~     This is a randomized, double-blind and placebo controlled phase 3 study to evaluate the~     efficacy and safety of F-627 in women with stage II-IV breast cancer receiving chemotherapy~     treatment.~   "
53087|NCT02872090|"~     The aim of this interventional, randomized, double-blind, monocentric, cross-over study is to~     quantify the possible deleterious effect on the cardiac autonomic nervous system control of~     two long-acting anticholinergic bronchodilatators (tiotropium and glycopyrronium) and one~     beta-2 agonist long-acting bronchodilatator (indacaterol ) in patients with mild COPD.~   "
53088|NCT02872077|"~     This study will assess the efficacy of needle auricular acupuncture (AA) in neonatal~     abstinence syndrome (NAS) infants who require pharmacologic therapy at the Tampa General~     Hospital NICU. The investigators will evaluate efficacy of needle AA as an adjunct treatment~     for NAS by means of total methadone dose exposure, peak withdrawal scores, and overall length~     of stay.~      This is the first study to evaluate efficacy of needle AA as an adjunct treatment for NAS by~     means of total methadone dose exposure, peak withdrawal scores, and overall length of stay.~   "
53089|NCT02872064|"~     Phase I/IIA, open label, non-randomised, single site trial in patients with primary breast~     cancer.~   "
53090|NCT02872051|"~     The purpose of this study is to investigate the efficacy of 1) a stepped mental health care~     intervention and 2) an integrated mental health care and vocational rehabilitation~     intervention for people on sick leave because of depression and anxiety in Denmark~   "
53091|NCT02872038|"~     The purpose of this study is to compare the efficacy of empirical antibiotics of~     CAPD-associated peritonitis with intraperitoneal, continuous dosing of cefepime monotherapy~     versus combination of cefazolin and ceftazidime. Patients were randomized to be administered~     either intraperitoneal cefepime 1 g loading then 250 mg all exchanges (treatment group) or~     cefazolin and ceftazidime (control group) in the same dose.~   "
53092|NCT02872025|"~     This is a pilot study to investigate the change in the immune microenvironment of high risk~     ductal carcinoma in situ (DCIS) after short term exposure to pembrolizumab.~   "
53093|NCT02871999|"~     Clinical trial on acupuncture adjuvant treatment in the pain after the surgery of~     gastrointestinal carcinoma. Gastrointestinal cancer patients are diagnosed by pathology or~     cell biology. Patients are randomized into 2 groups: The control group receive normal~     treatment only, the experimental group receive acupuncture therapy besides normal treatment.~     Clinical evaluation is based on the observation of the pain degree and life quality~     improvement. Blood biochemistry tests mainly include Prostaglandin~     E2(PGE2),5-hydroxytryptamine(5-HT), histamine(HIS), malondialdehyde (MDA), superoxide~     dismutase (SOD), glutathione peroxidase (GSH-Px), adrenaline, nor-adrenaline, tumor necrosis~     factor (TNF)-α, cell flow cytometry on Th1, Th2, Th17, Treg cytokines as well as serum~     cortisol, estradiol (female), progesterone (female), testosterone (male) etc.~   "
53094|NCT02871986|"~     The investigators wish to explore the variability of uterine, breast and bone outcome markers~     as surrogates to assess the adequacy of exogenous oestrogen replacement in individuals with~     hypogonadism.~   "
53095|NCT02871973|"~     The objective of this research is to conduct a small randomized pilot study to evaluate the~     feasibility of Sit Down and Play (SDP), a brief, low-cost program delivered in the primary~     care setting to enhance parent-child interactions and explore potential impacts on parenting~     behaviors.~   "
53096|NCT02871960|"~     The purpose of this study is to evaluate surgical stress and immune function after robotic~     versus laparoscopic colectomy.~   "
53097|NCT02871947|"~     Severe asthma is a heterogeneous disease characterized by the need for treatment with high~     doses of inhaled corticosteroids. It affects 5%-10% of asthmatic patients, although it~     accounts for a significant percentage of the consumption of health care resources. Severe~     asthma comprises various clinical and pathophysiological phenotypes. In this current study,~     we aimed to clinical characteristics and cytokes profile in severe asthma patients.~   "
53098|NCT02871934|"~     This study will determine whether using a genetic test (for the SLCO1B1 gene) can help~     patients and providers choose the right type and dose of cholesterol-lowering statin~     medications to lower the risk of cardiovascular disease, while minimizing the muscle pain~     side effects that sometimes occur with statins.~   "
53099|NCT02871921|"~     At each site (OHSU & UM), 180 socially isolated adults 80+ years old will be recruited~     through Meals on Wheels People. Participants will be randomized to either the Video Chat~     Group or the Control Group. Those in the Video Chat Group will receive a computer for the~     duration of the study, which they will use to video chat with study staff for 30 minutes/day~     4x/week for 6 months, and then they will video chat 2x/week for another 6 months. Those~     assigned to the Control Group will have brief telephone check-ins with study staff once per~     week. In-home testing will occur at Baseline, 6 months and 12 months. All participants at~     OHSU will have their medication compliance tracked using electronic medication monitoring~     devices (MedTracker) and 50% of participants at both OHSU and UM will have MRIs at Baseline~     and 6 months, if they are able to safely receive MRIs. All participants at both sites will~     contribute saliva for genetic testing, and all video chat sessions will be recorded for~     speech and language analysis.~   "
53100|NCT02871908|"~     The aim of this study is to assess the effect of Lactobacillus reuteri DSM 17938~     administration for the prevention of diarrhea and AAD in children.~   "
53101|NCT02871895|"~     In 2004, the Surviving Sepsis Campaign (SSC) introduced guidelines for the management of~     severe sepsis and septic shock, as well as strategies for bedside implementation. The~     treatment recommendations were organized in two bundles. In an international study, enrolling~     adult patients with severe sepsis admitted to these intensive care units, investigators found~     that while mortality from severe sepsis is high (44.5%), compliance with resuscitation and~     management bundles is generally poor in much of Asia. Investigators need to identify the~     patients at risk for high in-hospital mortality in order to take appropriate steps.~      From their past studies, investigators found that sepsis involved inflammation and~     coagulation. The multiple organ involvement was associated with interaction of novel~     biomarkers such as cytokines. There is limited data regarding comparing and application of~     biomarkers of different characteristic on sepsis treatment. A simultaneous detection of~     multiple cytokines may provide significant prognostic information. For other biomarkers,~     promising observation data have been put forward, but their potential needs to be evaluated~     in large-scale, well-designed prospective intervention studies before clinical use can be~     recommended. Besides many clinical studies on biomarkers were confounded by its lack of~     standard bundle care for severe sepsis patient.~      Here investigators performed a systematic study aimed at evaluating~        1. the individual and combined diagnostic accuracy of biomarkers for predicting mortality;~        2. whether trend change in biomarker level more useful for above prediction;~        3. which biomarker or biomarker combination checked can predict patients at risk of~          evolving with severe organ dysfunctions.~   "
53102|NCT02871882|"~     To study the effect of an ileocolonic formulation of ox bile extract on insulin sensitivity,~     postprandial glycemia and incretin levels, gastric emptying, body weight and fasting serum~     FGF-19 (fibroblast growth factor) levels in overweight or obese type 2 diabetic subjects on~     therapy with DPP4 (dipeptidyl peptidase-4) inhibitors (e.g. sitagliptin) alone or in~     combination with metformin.~   "
53103|NCT02871869|"~     Diffuse large B cell lymphoma (DLBCL), as the most common subtype non-Hodgkin lymphoma (NHL),~     has great heterogeneity in clinical manifestations, histological morphology and prognosis.~     R-CHOP Protocol (Rituximab + Vindesine + Cyclophosphamide + Epirubicin + Prednisone) is the~     gold therapeutic criteria for patients with NHL, and it is also used as the first-line~     treatment for patients with DLBCL. After treatment, 50％～60％of patients with DLBCL receive~     complete remission (CR), 30％～40％ recurrent and 10% will never be cured due to initial and~     secondary drug tolerance. This study aimed to explore whether Cinobufacini Tablets had~     synergistic effect in the treatment of DLBCL, and whether its action was in close association~     with the positive expression of Na+/K+-ATPase α3, and to observe the rates of adverse~     reactions induced by Cinobufacini Tablets during treatment.~   "
53104|NCT02871856|"~     People who may be at increased risk of lung cancer due to age and smoking history will be~     invited to participate in this international study to determine the best way of using~     computed tomography (CT) of the chest to screen for early lung cancer. Overseas data show~     that CT screening (screening tests can find diseases early, when they're easier to treat) can~     reduce deaths from lung cancer and this study will help determine who is most likely benefit~     from screening.~   "
53105|NCT02871843|"~     This is a two-part Phase I add-on clinical trial in newly diagnosed glioblastoma or GBM. By~     add-on what is meant is that the experimental intravenous therapy, RRx-001, is combined or~     added on to standard of care. In newly diagnosed GBM standard of care consists of~     radiotherapy + temozolomide (TMZ) for 6 weeks followed (after a 4-6 weeks break) by~     maintenance TMZ given until the tumor progresses or worsens. By maintenance therapy what is~     meant is that TMZ is given less frequently to prolong or extend the time during which the~     tumor remains stable.~      G-FORCE-1 will be conducted in two parts; in the first part of the study (Dose Escalation,~     Part A) patients will be entered or assigned sequentially (that is consecutively) to~     gradually escalating or increasing doses of RRx-001 after patients have been entered on the~     previous dose until such time as it is no longer tolerated. At each dose level, a separate~     cohort or small group of at least 3 evaluable patients will be treated. RRx-001 will be~     administered by intravenous infusion (in other words, by slow injection in the veins) over~     30-45 minutes once weekly during radiotherapy for 6 weeks followed by the FDA-approved~     chemotherapy, temozolomide (TMZ) alone for up to 6 months or longer.~      In the second part of this study (Part B), new groups or cohorts of patients will receive~     RRx-001 at the dose established in Part A by intravenous infusion over 30-45 minutes once~     weekly during radiotherapy for 6 weeks. Then, after a 4-6 weeks break, each cohort will~     receive increasing doses of RRx-001 and temozolomide (in other words, a double dose~     escalation) to establish an acceptable safety and activity window, in other words, a dose~     range that is relatively free of toxicity as well as active against the tumor, although the~     primary purpose of this study is to assess or evaluate safety.~      The reason or rationale to add on RRx-001 to radiotherapy and TMZ, which is described in~     more detail below on this page, is as follows: RRx-001 is a radiosensitizer and a~     chemosensitizer, which means that experimentally it increases the activity of radiation and~     chemotherapy in tumors. In addition, in other ongoing clinical trials, patients have~     experienced minimal toxicity or side effects with RRx-001 alone and also in combination with~     radiation in the brain; therefore, the hope is that RRx-001 will synergize or combine well~     with radiotherapy and TMZ in GBM without adding toxicity~   "
56660|NCT02825355|"~     This study aims to evaluate the effect of SLN mapping compared to conventional radical PL on~     the incidence and severity of lymphedema in women with early stage cervical and endometrial~     cancer.~   "
53106|NCT02871830|"~     Children and young people are recommended to undertake at least 60 minutes of moderate to~     vigorous intensity physical activity each day. However recent findings have indicated that~     only 51% of children aged 7 years were meeting these guidelines. Previous research has also~     highlighted girls are significantly less active than. Furthermore, children living in~     Northern Ireland are least likely to meet the guidelines, with only 43.4% of children here~     reaching the recommended ≥ 60 minutes a day. The development of interventions which can~     successfully increase levels of physical activity in adolescent girls in Northern Ireland is~     of key importance. The aim of this intervention is to investigate whether or not girls (aged~     11-13 years) can increase their daily levels of physical activity over a 12 week period by~     taking part in a school-based brisk walking intervention. The impact of participating in a~     school-based brisk walking intervention on a range of other outcome measures will also be~     investigated. A total sample of 200 adolescent females will be recruited onto the study, with~     recruitment of participants taking place at the school level. Following written consent from~     parents/guardians and assent from participants, participants will be randomised at the school~     level to either participate in the walking intervention or to act as controls. Objective~     physical activity will be assessed at 3 time points using an Actigraph accelerometer. At~     baseline, post-intervention (12 weeks) and follow up (4 months post-intervention)~     participants will also undergo measurements of height, weight, waist and hip circumference,~     bloody pressure, and cardiorespiratory fitness. Participants will also complete~     questionnaires assessing levels of physical activity and a number of psychosocial variables~     at each time point. Following completion of follow up measurements, a sub-sample of~     participants (n=45) will be invited to take part in focus groups to evaluate their~     experiences of the intervention.~   "
53107|NCT02871817|"~     The CLEAR study is testing the level of agreement between visual acuity and Amsler grid~     testing using a mobile vision testing application, Checkup Study, and standard in office~     methods. In addition the percent of patients able to successfully complete home testing on~     the digital device will be assessed.~   "
53108|NCT02871804|"~     Eligible patients will be centrally randomized to either Arm A (resection of the splenic vein~     after isolation from the pancreatic parenchyma) or Arm B (co-resection of the vein together~     with the pancreas).~   "
53109|NCT02871791|"~     This research study is studying a combination of targeted therapy and hormonal therapy as a~     possible treatment for breast cancer that has spread to other places in the body and is~     hormone receptor positive (HR+) and HER2-negative.~      The names of the study interventions involved in this study are:~        -  Palbociclib~        -  Everolimus~        -  Exemestane~   "
53110|NCT02871778|"~     To evaluate the safety and efficacy of treatment with VX-371 with and without ivacaftor, and~     the effect of VX-371 with and without ivacaftor on quality of life (QOL) in subjects with~     primary ciliary dyskinesia (PCD).~   "
53111|NCT02871765|"~     The objective of this study is to evaluate an educational program for Atrial Fibrillation~     patients under Warfarin treatment regarding to patients' knowledge of Warfarin, related life~     distresses and quality of life.~   "
53112|NCT02871752|"~     We propose to examine the efficacy of couples-based mindfulness-based stress reduction (MBSR)~     on positive and negative psychological responses to active surveillance (AS) and AS~     adherence, with a sample of men on AS and their spouses.~   "
53113|NCT02871739|"~     The Health Decision Sciences Center (HDSC) staff has deployed different approaches to~     training clinicians to engage patients in shared decision making for common medical tests and~     treatments. The purpose of the study is to compare the effectiveness of shared decision~     making (SDM) skills training courses using standardized patient interactions (SPI) and~     written evaluations.~   "
53114|NCT02871726|"~     The commonly used diagnostic procedure for prostate cancer, a transrectal ultrasound~     (TRUS)-guided biopsy, has significant limitations. Freehand biopsy cores are often spatially~     clustered, rather than uniformly distributed, and do not accurately follow the recommended,~     sextant template. In addition, a freehand TRUS-guided biopsy does not allow precise mapping~     of the biopsy cores within the prostate. Therefore, it is nearly impossible to re-biopsy or~     target the exact cancer foci. As a result, most TRUS-guided prostate biopsies today are~     poorly targeted and their spatial mapping remains subjective.~   "
53115|NCT02871713|"~     Pain after caesarean delivery (CD) can interfere with the moms' ability to look after her~     baby and may contribute to developing long term pain and disability. Women having a CD~     receive pain medication (morphine) as part of their spinal anesthetic to help with pain~     relief after surgery. Morphine works well however has several side effects such as nausea,~     vomiting and itching which may be severe enough to make it difficult to care for herself and~     her new baby. In some cases, morphine causes difficulty in passing urine within first~     24-hours of the CD requiring catheterization and thus restricting mobilization. The quadratus~     lumborum block (QLB) is a newer nerve block that uses local anaesthetic solution to numb the~     nerves carrying pain sensation from surgical incision site. QLB may be able to provide~     effective pain control without the side-effects associated with the spinal morphine. This~     study is to determine if women receiving QLB have as good pain control with fewer side~     effects than those who do receive the spinal morphine. Adequate pain control will be assessed~     by their pain scores and recovery in the 24 to 48 hours after CD. The side effect profile of~     the two techniques, quality of recovery and long term impact will also be compared during~     this study.~      In addition, we would like to compare the patients who received both analgesic regimens (ITM~     and QLB) with patients who received only one analgesic intervention (i.e. either ITM or QLB).~     Further, the study will help us answer if combining the two analgesic interventions if~     beneficial or not.~   "
53116|NCT02871700|"~     The specific aims of this study will be to:~        1. investigate the treatment efficacy of Action observation therapy (AOT), mirror therapy~          (MT) versus a control intervention on motor and functional outcomes of stroke patients.~        2. compare the mechanisms and changes in cortical neural activity after AOT, MT, and~          control intervention by using magnetoencephalography (MEG).~        3. determine the correlations between neural activation changes and clinical outcomes after~          AOT and MT.~        4. identify who are the potential good responders to AOT and MT.~   "
53117|NCT02871687|"~     The purpose of this research protocol is to determine if the same effects are observed in~     vivo in humans through a randomized controlled study. Data regarding a novel mechanism of the~     widely used statin class of medications on the mineralocorticoid pathway would likely have~     significant clinical implications on the future management of hypertension and other~     cardiovascular disease given the known pleiotropy of aldosterone action.~   "
53118|NCT02871674|"~     The study aims to implement and evaluate an RCT of behavioural sleep interventions for~     children aged 5-12 years with ADHD, and their primary caregivers, (women) in Saudi Arabia to~     address the following questions:~        1. To what extent can a behavioural intervention improve sleep difficulties and increase~          sleep duration in children with ADHD?~        2. To what extent do intervention-induced changes in sleep for children or primary~          caregivers (women) account for any changes in ADHD symptoms?~   "
53119|NCT02871661|"~     INTRODUCTION: Vulvodynia (chronic vulvar pain in the absence of clinical findings) has a~     negative impact over quality of life in women with this diagnose. The existing treatments,~     however, are manifold but insufficient. This study aims to verify the effectiveness of~     kinesiotherapy and electrotherapy as adjuvant methods in the treatment of vulvodynia.~     METHODS: A single-blind randomized controlled trial will examine 58 women, divided into three~     treatment arms: use of tricyclic antidepressant alone (hydrochloride Amitriptyline),~     amitriptyline hydrochloride associated with pelvic floor muscle exercises and amitriptyline~     hydrochloride associated with electrotherapy (interferential current). Exclusion criteria~     are: presence of infections or genital cancers, chronic degenerative diseases; younger than~     18 years, neurological disease that jeopardizes the contraction of the muscles of the pelvic~     floor, taking antidepressant drugs that have interaction with amitriptyline hydrochloride and~     being pacemakers use. The parameters analyzed before and after treatment will be: muscle~     volume of the anus elevator and perfusion of the pudendal artery obtained with 3D ultrasound,~     subjective pain in vaginal intercourse (visual analog scale), monthly frequency of vaginal~     intercourse, pain referred within vulvar touch on physical examination (swab test from zero~     to 10) and female sexual function (Female Sexual Function questionnaire - FSFI). There will~     be a follow up of subjective pain in vaginal intercourse and monthly frequency of vaginal~     intercourse obtained by telephone contact with the voluntary on one, six and twelve months~     after the end of interventions. The data will be analyzed using Chi-square test of Pearson,~     Fisher exact and Mann-Whitney. The beginning and end of treatment will be compared using the~     Wilcoxon test (related samples) and McNemar (effect of the intervention), considering~     statistical significance level of 5%. The software used is the statistical analysis software~     (SAS) - Release 9.1, SAS Institute, Cary, North Carolina, USA, 2002-2003 and Statistical~     Package for the Social Sciences (SPSS) -Release 17.0.~   "
53120|NCT02871648|"~     The purpose of this research protocol is to determine if the same effects are observed in~     vivo in humans using a similar approach. Demonstrating that mineralocorticoid acts on zona~     glomerulosa cells to regulate aldosterone production in a short feedback loop would provide~     important insight into hormone regulation, and explain variability in pathophysiologic states~     such as hypertension and cardiovascular diseases.~   "
53121|NCT02871635|"~     Primary Objective:~      The primary objective of this trial is to compare the clinical efficacy of BI 695501 with~     EU-approved Humira® in patients with active Crohn's disease (CD).~      Secondary Objectives:~      The secondary objectives of this trial are to compare the efficacy and safety of BI 695501~     with EU-approved Humira® across the induction and maintenance phases.~   "
53122|NCT02871622|"~     Prospective, multi-center, registry designed to enrol up to 2,000 patients in up to 35~     International centers. All patients will receive a BioMatrix AlphaTM stent as per clinical~     practice and will be followed for 2 years for data collection. Major adverse cardiac events~     (MACE) results at 9 months will be compared to the results obtained from the BioMatrix FlexTM~     arm of the LEADERS trial.~   "
53123|NCT02871609|"~     This study is performed to analyze various aspects of biofilms on ureteral stents in a~     longterm setting.~   "
53124|NCT02871596|"~     The purpose of the study is to determine the effects of both an anthocyanin-rich polyphenol~     blend and an anthocyanin-rich polyphenol blend combined with a prebiotic blend on fecal~     microbiota metabolism (assessed by gas chromatograph - mass spectrometry (GC-MS) headspace~     analysis) and fecal microbiota composition (assessed by next generation sequencing).~   "
53125|NCT02871583|"~     The aim of the present prospective controlled study is to compare the trunk muscle strength,~     quality of life and neuropathic pain component after Lichtenstein and Kugel procedures.~   "
53126|NCT02871570|"~     The purpose of this study is to determine the effect of hepatic impairment on rivipansel PK~     and safety.~   "
53127|NCT02871557|"~     This was a prospective multicenter cohort study of elderly people admitted to the acute care~     for elders in Martinique. They were followed up to 36 months. It aimed to study the adverse~     outcomes. In all, 287 subjects were included. They were 85+/-6 years, and mainly women (61%).~   "
53128|NCT02871544|"~     Objective: to clarify the predictive value of brain natriuretic peptide (BNP) in combination~     with neutrophil gelatinase associated lipocalin (NGAL) for the prognosis of patients with~     sepsis.~   "
53129|NCT02871531|"~     Objective: To compare outcomes of retinal detachment repair following pneumatic retinopexy~     (PnR) versus pars plana vitrectomy in terms of anatomical success, functional success and~     patient quality of life in patients with extended criteria.~      Methods: A prospective, randomized, controlled trial will be conducted with 178 patients~     presenting at St. Michael's Hospital with primary retinal detachment (RD). Inclusion criteria~     include: a single or multiple retinal tears in detached retina between 7 and 5 o'clock being~     of any size and any distance apart from each other, including giant retinal tears with~     inferior aspect above 5 and 7 o'clock, RD with no identifiable tear but where suspected tear~     is between 7 and 5 o'clock, retinoschisis with RD if tears are located between 7 and 5~     o'clock, mild proliferative vitreoretinopathy, none or mild vitreous hemorrhage. Patients~     will be excluded if there is a small retinal tear or multiple tears less than 30o apart~     between 8 and 4 o'clock in detached retina, retinal tear in detached retina between 5 and 7~     o'clock, <18 years old, inability to read English, mental incapacity, previous history of RD,~     scleral buckle or vitrectomy in index eye, inability to maintain appropriate head posture at~     post-operative period and inability to visualize peripheral retinal due to media opacity.~     Patients will be randomly allocated into two groups: PnR + cryotherapy/laser or vitrectomy +~     cryotherapy/laser and the intervention will take place within 24 hours and 72 hours for~     attached and detached macula status, respectively. Patients will undergo a complete~     ophthalmological examination, including visual acuity and fundus assessment at baseline and~     at 3, 6 and 12 months after surgery. Visual acuity will also be measured at 1, 7 and 30 days~     after surgery. Global health related quality of life will be evaluated with the SF-36v2~     questionnaire at baseline, 1 month, 1 and 2 years after intervention, while the VFG25~     questionnaire will be applied at 3, 6, 12 and 24 months after surgery to measure vision~     related quality of life.~   "
53130|NCT02871518|"~     This is a Phase II trial to study the effectiveness of two cycles versus three cycles of~     Concurrent Chemoradiotherapy in treating patients with Low Risk Locoregionally Advanced~     Nasopharyngeal Carcinoma based on pretreatment plasma EBV DNA.~   "
53131|NCT02871505|"~     The investigators compare the treatment results and clicical presentations of different~     Molecular subtyping of Treponema pallidum~   "
53132|NCT02871492|"~     Randomized, double-blind, multi-center, three arm parallel group, comparative trial to assess~     pritelivir ointment safety and efficacy, ie, proportion of subjects with non-ulcerative~     lesions, in adult subjects with recurrent herpes labialis (RHL) in comparison with placebo or~     Zovirax® Cream. The start of treatment with trial medication will be initiated by the subject~     within one hour of noticing the first sign or symptom (eg, prodrome) of a recurrence of~     herpes labialis. Trial medication will be applied to the affected area 5 times daily for 4~     days.~      After self-initiation of treatment with trial medication subjects will be assessed daily by~     the Investigator until complete healing for a maximum of 13 days.~      Subjects will document application of trial medication and the status of their lesion in a~     diary. There will also be blood sampling, ECG measurement and physical examination performed~     at the investigational site.~   "
53739|NCT02863549|"~     The aim of this study was to investigate the procedural feasibility and 30-day results of~     transcatheter tricuspid valve repair using the MitraClip® system (Abbott Vascular) in~     selected, highly symptomatic patients with severe tricuspid regurgitation (TR).~   "
53134|NCT02871466|"~     stem cells therapy may be a choice therapy for advanced heart failure patients refractory to~     medical therapy, internal cardiovertor with a defibrillator (ICD) recipients, and a previous~     history of myocardial infarction and coronary artery revascularization. These patients,~     without indication to receive a cardiac resynchronization therapy (CRT), may have a worsening~     of heart failure, and symptoms of coronary artery disease. In this study we have evaluated in~     consecutive 30 selected patients the amelioration in failing heart NYHA class,~     hospitalization rate, echocardiographic left ventricle functionality, and associated to~     reduction of angina after a treatment with stem cells intra thoracic infusion.~   "
53135|NCT02871453|"~     The investigators design a randomized, control study to evaluate the therapeutic effect of~     scalp acupuncture using Jiao's motor area for motor dysfunction in ischemic stroke patients~     using the following outcomes: motor function, activity of daily living,quality of life.~   "
53136|NCT02871440|"~     Omega 3 (OM3) Tear is a new unit dose emulsion, containing flaxseed/castor oil, which is~     being developed by Allergan. It is desirable to understand the effect that this new emulsion~     has on tear film evaporation and tear lipid profile via interferometry, in patients with~     evaporative dry eye (EDE) and those without (non-EDE). It would also be valuable to evaluate~     the retention time of the lipid components of the new emulsion via tear collection and~     analysis in EDE and non-EDE patients~   "
53137|NCT02871427|"~     This study seeks to evaluate the long-term safety and effectiveness of nelotanserin for the~     treatment of visual hallucinations (VHs) and Rapid Eye Movement (REM) Sleep Behavior Disorder~     (RBD) in subjects with Lewy body dementia (LBD).~   "
53138|NCT02871414|"~     The purpose of the project is to improve the sleep quality and sleep duration of post 9/11~     veterans seeking college degrees. Preliminary research findings within CSU's New Start for~     Student Veterans program indicate veterans with service-related injuries report difficulties~     with sleep quality and duration. The REST program will recruit 24 college veterans and engage~     them in a seven-week multi component sleep improvement program using evidence-based~     educational and behavioral change supports that are considered best practice for improving~     sleep quality. The investigators' scientific objectives in this application are to establish~     the efficacy of a group-based sleep education and sleep-skills intervention to improve sleep~     quality and duration, and to advance understanding of relationships between participants'~     sleep-related knowledge and behaviors associated with improved sleep quality and duration in~     veterans with service-related injuries in college. The investigators will initially engage 8~     participants to establish treatment fidelity and participant satisfaction of the 7-week group~     intervention. This will be followed by engaging 16 additional participants in the 7-week~     group intervention, 8 will be randomly placed as wait-list controls and then receive the~     intervention. The 7-week group intervention will take place within the CSU Occupational~     Therapy Department, and all assessments will be completed using a web-based survey.~   "
53139|NCT02871401|"~     The investigators will conduct a single-center, prospective, randomized, placebo-controlled,~     double-blind pilot study of anti-herpesvirus therapy in patients with idiopathic pulmonary~     fibrosis (IPF). Patients with mild, moderate or severe IPF with serologic evidence of current~     or past Epstein-Barr Virus (EBV) or cytomegalovirus (CMV) infection. Randomization will be to~     pirfenidone plus placebo or pirfenidone plus valganciclovir. Thirty subjects will be enrolled~     and randomized to treatment with pirfenidone plus valganciclovir (20 subjects) or pirfenidone~     plus placebo (10 subjects) for 12 weeks. The primary outcome will be safety and tolerability~     will be determined by type, frequency and duration of adverse events (AEs) and serious~     adverse events (SAEs) after 12 weeks of study drug treatment. All study subjects will be~     offered bronchoscopy with bronchoalveolar lavage (BAL) at study initiation and upon~     completion of treatment (12 weeks). Subjects will then be followed up at routine clinic~     visits at 6, 9 and 12 months for data collection.~   "
53140|NCT02871388|"~     The objective of this protocol is to adapt and pilot test an existing lifestyle modification~     intervention for weight loss for women with overweight or obesity who have had a recent false~     positive mammography screen. The purpose of this pilot trial is to establish feasibility of~     Connect Online to Engage Change Tool (CONECT) to promote weight loss through increased~     physical activity and diet change.~   "
53141|NCT02871375|"~     The purpose of this study is to evaluate DAILIES TOTAL1® Multifocal (DTl MF) contact lenses~     in current multifocal contact lens wearers with symptoms of end of day discomfort compared to~     their habitual multifocal contact lens correction.~   "
53142|NCT02871362|"~     The purpose of this study is to evaluate the benefit and tolerability of IQP-AS-118 on the~     systolic and diastolic blood pressure (BP) and to explore the effects on parameters of lipid~     metabolism in subjects with elevated BP and low density lipoprotein cholesterol (LDL-C)~     levels in a pilot study.~   "
53143|NCT02871349|"~     The purpose of this study is to find out how the brain of people with autism is affected by~     Propranolol. Propranolol is not FDA approved for the treatment of autism. Propranolol is FDA~     approved for the treatment of heart conditions such as blood pressure~      This research is being done because there are currently no drug treatment options for~     language impairments and social difficulties often experienced by people with autism.~   "
53144|NCT02871336|"~     This data base has been set in order to gather medical and surgical information from patients~     who have undergone surgery for pancreatic cancer, at Institut Paoli Calmettes or Assistance~     Publique des Hôpitaux de Marseille, France.~   "
53145|NCT02871323|"~     The main purpose of this investigational research study is to determine how safe and~     tolerable the study drug, MEDI4736 (Durvalumab), is in patients with myelofibrosis (MF). The~     study drug belongs to a group of drugs called immune checkpoint inhibitors, which have shown~     promise in other forms of cancer, such as melanoma and lung cancer. One of the effects that~     this drug has is to activate the patient's own natural immune system. The purpose of this~     study is to examine the safety and tolerability of the study drug, to study how effective it~     is at treating patients with myelofibrosis, and to explore how certain markers in the~     patient's blood and/or bone marrow may be affected by the study drug.~   "
53146|NCT02871310|"~     The main objective of this study is to evaluate the benefit of IQP-AS-118 on the vasoactive~     effects in healthy subjects.~   "
53147|NCT02871297|"~     Evaluation of the long-term safety and tolerability of vortioxetine in child and adolescent~     patients with a Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5™)~     diagnosis of MDD~   "
53148|NCT02871284|"~     Chemotherapy-induced peripheral neurotoxicity (CIPN) as a side effect of chemotherapy~     negatively affects patients' quality of life and may lead to treatment disturbances. CIPN is~     frequently recorded in patients treated with alkylating platinum-based drugs, antitubulins~     including the taxanes and vinca alkaloids, and other drugs including suramin, thalidomide,~     lenalidomide and the proteasome inhibitor bortezomib, representing one of the most severe and~     potentially dose-limiting non-hematological toxic effects. Sufficient treatment options or~     preventive measures are lacking.~      There is evidence that physical activity strategies are able to address existing CIPN~     symptoms and potentially increase quality of life in affected patients. CIPN symptoms~     involves restrictions of sensory and sometimes motor modalities, for example, deficits in~     plantar perception and dysfunction of postural control and one study in type II diabetes~     patients also suggested that structured exercise might have a preventive potential with~     regard to peripheral neuropathy incidence.~      Based on these findings, we aim to investigate the preventive potential of a sensorimotor~     intervention vs. machine-based resistance training vs. usual care (wait-list control group)~     in a randomized controlled three-arm intervention trial among cancer patients undergoing~     chemotherapy with high risk for CIPN. On the basis of power calculations, the goal is to~     include 82 patients per intervention arm resulting in a total patients number to be enrolled~     of n=246. CIPN symptoms will be assessed objectively via comprehensive clinical and~     electrodiagnostic examinations (Total Neuropathy Scale; TNS-reduced) and subjectively via~     questionnaires (EORTC QLQ-CIPN20 & FACT-GOG-Ntx, EORTC QLQ-C30). Additionally CIPN and the~     effectiveness of the selected interventions will be objectively evaluated by spectral~     analysis of Centre of Pressure (COP) variations. Further key secondary endpoints are:~     physical performance, sleep quality and chemotherapy compliance.~   "
53149|NCT02871271|"~     The purpose of this study is to evaluate the tolerability and benefit of IQP-AS-121 on~     reducing fatigue and tiredness and to improve mental alertness.~   "
53150|NCT02871258|"~     To study objective is to evaluate the impact of use of The MetaNeb® System in clearance of~     atelectasis, as demonstrated by improvement in chest x-rays. This is a a non-randomized open~     label study, with all subjects receiving treatment with The MetaNeb® System. Subjects who~     qualify for enrollment in the study will receive therapy with The MetaNeb® System following~     the labeled instructions for the device. Details of the treatment including duration and~     frequency will be defined in treatment procedures.~   "
53151|NCT02871245|"~     Patients accepted laparoscopic radical operation for carcinoma of colon and upper middle~     section of the rectum will be as the research object. Cancer patients are diagnosed based on~     pathology or cell biology. The trial is randomized, parallel and open. They are randomized~     into 2 groups: both groups receive surgery. The experimental group receives conventional~     treatment combine with electroacupuncture Zusanli point .etc finish operation and the~     contrast receives the same conventional treatment with experimental group. Clinical~     evaluation includes gastrointestinal tract recovery of function, pain relief, life quality~     improvement. Blood biochemistry tests mainly include gastrin(GAS), stress related hormone,~     peroxidatic reaction and the ratio of immune cells.~   "
53152|NCT02871232|"~     To conduct surveillance for abuse, misuse, overdose, addiction, and death and to evaluate if~     the REMS meets its surveillance goals, and if it does not, to modify it appropriately based~     on the metrics. Briefly, therefore, the overall surveillance objective is to evaluate for~     trends before and after the shared REMS is implemented to collectively assess for changes in~     abuse, misuse, overdose, addiction, and death for different risk groups and settings.~   "
53153|NCT02871219|"~     The goal of this clinical research study is to learn if combining obinutuzumab and~     lenalidomide can help to control previously untreated FL.~      This is an investigational study. Obinutuzumab is FDA approved and commercially available for~     the treatment of chronic lymphocytic leukemia (CLL). Lenalidomide is FDA approved and~     commercially available for the treatment of different types of lymphoma and multiple myeloma~     (MM). It is considered investigational to combine obinutuzumab and lenalidomide to treat FL.~      The study doctor can explain how the study drugs are designed to work.~      Up to 90 participants will be enrolled in this study. All will take part at MD Anderson.~   "
53154|NCT02871206|"~     This study is a randomized controlled trial (RCT) comparing adjuvanted influenza vaccine (AV)~     to unadjuvanted inactivated influenza vaccine (IIV). Children in Hutterite colonies in~     Alberta and Saskatchewan will receive AV or IIV. The goal of this study is to determine~     whether the AV vaccine, can provide increased community-wide protection.~   "
53155|NCT02871193|"~     The procedures of thoracotomy are among the most painful operations. In addition to~     post-thoracotomy pain, the outcomes of surgery are affected adversely by postoperative~     discomfort. Therefore, post-thoracotomy pain control can improve the satisfaction of patient~     and prevent postoperative complications such as pneumonia, atelectasis, or respiratory~     failure. Thoracic epidural analgesia (TEA) used to be widely considered as a standard~     technique for providing analgesia after a thoracotomy. However, TEA carries side-effects such~     as incomplete or failed block, epidural hematoma, abscess, hypotension, respiratory~     depression, or bradycardia, etc. Recently, thoracic paravertebral block (TPVB) is an~     alternative technique for TEA that may offer a comparable analgesic effect and a better side~     -effect profile for post-thoracotomy analgesia. When local anesthetic agents are used as~     single injection, they can provide analgesia for limited period. Various adjuvants have been~     tried in the past in order to enhance the duration and quality of postoperative analgesia.~     Previous studies with perineural dexamethasone demonstrated that it enhanced the duration of~     local anesthetic block. The mechanism of its action is blocking the nociceptive impulse~     transmission along the myelinated C fibers. Patient-controlled analgesia (PCA) devices have~     been shown to provide superior analgesia and greater patient satisfaction compared with~     intermittent administration. System of wire-less PCA provides remote monitoring, information~     management and PCA devices with high precision. The purpose of this research is to determine~     whether dexamethasone might prolong the duration of analgesia and improve the short-time~     outcomes when administered for TPVB along with local anesthetic agents in elective~     thoracotomy.~   "
53156|NCT02871180|"~     Twenty patient with Type 1 diabetes, using insulin glargine as basal insulin, participated in~     a prospective, controlled crossover trial comparing blood glucose profiles over two 24 h~     periods with and without a late night snack (a slice of rye bread, 20 g carbohydrates, at 10~     p.m.), in randomized order. The main endpoint was the number of hypoglycemic episodes with a~     confirmed laboratory blood glucose ≤ 50 mg/dl between 10 p.m. and 8 p.m. the following day.~     Secondary endpoint was the blood glucose profile during this period.~   "
53157|NCT02871167|"~     The aim of the study is to perform a French multicenter prospective interventional study in~     order to assess the feasibility and safety of ovarian hyperstimulation for oocyte / embryo~     cryopreservation in young women with breast cancer. The oncologic and reproductive benefit /~     risk ratio will be investigated in the oncology and reproductive area.~   "
53158|NCT02871154|"~     Our and others experience suggest that in some cases delaying oocyte pick up (OPU) for more~     than 39 hours after hCG injection may be of benefit.~      We plan to apply this to 20 women in whom less than 20% of oocytes were found suitable for~     intracytoplasmic sperm injection. The delay will be for up to an interval of 47 hours from~     hCG to OPU.~   "
53159|NCT02871141|"~     The project aims to investigate markers of neural activity and connectivity, neurochemistry,~     hypothalamic-pituitary-adrenal (HPA) axis activity, inflammation and neuronal plasticity~     underlying treatment response and remission after ECT. These measures will be assessed in~     depressive patients prior, during and after ECT and also after 6 months. Furthermore, we will~     investigate a control group of depressive patients treated with antidepressants.~   "
53160|NCT02871128|"~     Iron deficiency problem has always been in Taiwan. This is a randomized, double-blind trial.~     Subjects separate to 3 groups, one group (n = 20) take two Natureheme-iron capsules a day for~     a total of 12 weeks, another group (n = 20) with the same dose of placebo, and the other~     group (n = 20) is a commercial iron supplement. We assess whether Natureheme-iron can promote~     iron absorption and antioxidant effects, and compare the effects with commercial iron~     supplement. When this study is completed, it will increase the value of Natureheme-iron, and~     can improve health of Taiwanese.~   "
53161|NCT02871115|"~     The purpose of this research study is to address the challenge of medication management for~     older patients undergoing treatment for cancer. The sponsor of this protocol is the~     Massachusetts General Hospital Cancer Center who is providing funding for this research~     study.~   "
53162|NCT02871102|"~     Acute respiratory distress syndrome (ARDS) is a widely prevalent and morbid disease for which~     the current standard treatment is supportive care and avoidance of complications with~     lung-protective ventilation. Lower-tidal volume ventilation has been largely accepted as a~     means of lung protective ventilation, but the mechanism for its effectiveness is not yet~     clear, and debate remains as to how best to choose positive end-expiratory pressure (PEEP).~     Reduction in driving pressure (plateau pressure minus PEEP) has been suggested as a possible~     means to minimize ventilator-induced lung injury. This protocol aims to identify the range of~     safe paired-settings of PEEP and tidal volume, with selection guided by driving pressure and~     the stress index, a tool to recognize potential lung hyperinflation during mechanical~     ventilation.~   "
53163|NCT02871089|"~     The purpose of the study is to use a novel treatment approach, the artificial pancreas, after~     diagnosis of type 1 diabetes (T1D) to improve glucose control with the anticipated~     improvements of residual C-peptide secretion.~      This is an open-label, multicentre, single-period, randomised, parallel group design study.~     It is expected that a total of up to 190 subjects (aiming for 96 randomised subjects) will be~     recruited within ten working days of diagnosis of type 1 diabetes through paediatric diabetes~     centres in the UK. Half of the participants aged 10 to 17.9 years will be treated by~     conventional insulin injections and the other half by the artificial pancreas (closed loop~     insulin delivery system). Each treatment will last 24 months.~      Subjects in the intervention group will receive additional training on components of the~     artificial pancreas, i.e. insulin pump and continuous glucose monitoring (CGM), prior to~     starting closed loop insulin delivery. Subjects in the control intervention group will~     continue with standard therapy, i.e. multiple daily injection therapy. The study includes up~     to 14 visits and 1 telephone/email contact for subjects completing the study. After run-in~     and randomisation, visits will be conducted every 3 months in both arms. Beta-cell function~     will be assessed by serial measurement of C-peptide in response to a standardised mixed meal~     tolerance test (MMTT). MMTTs will be conducted at baseline, 6-,12- and 24 months post~     diagnosis.~      The primary outcome is the between group difference in the area under the stimulated~     C-peptide curve (AUC) of the MMTT at 12 month post diagnosis. Secondary outcomes include~     between group differences in stimulated C-peptide AUC over 24 months, differences in~     glycaemic control as assessed by HbA1c, time spent in glucose target range, glucose~     variability, hypo- and hyperglycaemia as recorded by periodically applied CGM, as well as~     insulin requirements and change in bodyweight. Additionally, cognitive, emotional and~     behavioural characteristics of participating subjects and parents will be assessed, and a~     cost utility analysis on the benefits of closed loop insulin delivery will be performed.~     Safety evaluation comprises assessment of the frequency of severe hypoglycaemic episodes,~     diabetic ketoacidosis (DKA) and number, nature and severity of other adverse events.~   "
53164|NCT02871076|"~     The objective of this study is to determine if acupuncture is an effective treatment option~     for treating combat Veterans with PTSD.~   "
53165|NCT02871063|"~     The purpose of this piece of research is to assess the effect of altitude on the clinical~     evolution of ARDS. For this purpose, patients who live and receive care at sea level are~     compared with those who live and receive care at high altitudes. For reasons of convenience,~     a cut-point of 1500 meters above sea level was chosen. In addition to this, it will be sought~     to assess whether adjusting the cut-points for the severity categories of ARDS improves the~     ability to predict some adverse events, by comparison with unadjusted cut-points. The results~     of this research will probably be disruptive, and will provide the first information yet~     about the effect of altitude on ARDS; they will therefore be of great interest for the~     international scientific community and for the direct care of patients. A high bibliometric~     impact is to be expected.~   "
53166|NCT02871050|"~     The purpose of this study is to create a biobank, which collects, stores, and distributes~     samples of human tissues, blood, and related health information to qualified scientists, in~     order to help doctors and researchers better understand why Castleman Disease occurs and~     develop ways to better treat and prevent it.~   "
53167|NCT02871037|"~     The current study is the first clinical trial proposed with PF-05221304. It is designed to~     evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of~     single and repeated doses of PF-05221304 to healthy adult subjects. The study may also~     evaluate effect of food on PK of PF-05221304.~   "
53168|NCT02871024|"~     Toraymyxin is an extracorporeal hemoperfusion cartridge containing Polymyxin B-immobilized~     fiber column designed to reduce blood endotoxin levels in sepsis. Meta-analysis of randomized~     trials showed that polymyxin B hemoperfusion significantly reduced the mortality of severe~     sepsis; however, the evidence was mainly contributed by the studies of abdominal sepsis. The~     data about using polymyxin B hemoperfusion to treat non-abdominal sepsis remain very limited.~     Investigators designed a clinical trial to evaluate the efficacy of polymyxin B hemoperfusion~     on treating non-abdominal severe sepsis. The study hypothesis is that removal of endotoxin by~     polymyxin B hemoperfusion in patients with pneumonia or urinary tract infection (UTI)-related~     severe sepsis will attenuate sepsis associated microcirculation failure and result in early~     reversal of shock and less extent of end-organ damage.~   "
53169|NCT02871011|"~     The purpose of this study is to determine the fungicidal efficacy of nitric oxide releasing~     solution footbath and it's effect on the clinical signs and symptoms associated with Tinea~     Pedis~   "
53740|NCT02863536|"~     The POLARIS trial is designed as a multicenter, open label, non-comparative, 3 months,~     clinical study.~      Interventional, non-controlled, multicenter trial with a prospective design on one cohort of~     patients~   "
53171|NCT02870985|"~     The clinical investigation is a non-inferiority, multicenter, blinding evaluation,~     randomized, parallel controlled clinical study enrolling up to 440 subjects. All subjects~     will be randomized 1:1 to receive the BIOTRONIK Orsiro SES or the Abbott Xience Prime™ EES,~     in order to evaluate the efficacy and safety of the SES drug eluting stent in the treatment~     of coronary artery disease.~   "
53172|NCT02870972|"~     This 3-part study will evaluate the safety and efficacy of an oral treatment, BCX7353, in~     preventing angioedema attacks in subjects with hereditary angioedema (HAE). In Part 1 of the~     study, eligible subjects will be randomized to receive oral BCX7353 or placebo for 4 weeks.~     Assuming successful completion of Part 1, additional subjects will be randomized in Part 2 to~     one of 2 lower doses of BCX7353 or placebo. Part 3 will enroll additional subjects into one~     of three doses of BCX7353 or placebo. The study will compare the number of acute attacks in~     each treatment group, as well as a number of other clinical and pharmacologic outcomes, and~     the safety and tolerability of each dose of BCX7353 compared to placebo.~   "
53173|NCT02870946|"~     Extracorporeal membrane oxygenation (ECMO) is a temporary mechanical circulatory support~     device for cardiogenic shock (CS) patients. During ECMO support, renal replacement therapy~     (RRT) facilitate more rapid metabolic or uremic control and more effective prevention and~     management of fluid overload which happened in critical state. CS patients who are likely to~     receive ECMO support will be enrolled and randomized with a 1:1 allocation to a simultaneous~     RRT arm vs. standard care arm.~        1. The patients in the simultaneous RRT arm will receive RRT when ECMO is commenced.~        2. The patients in the standard care arm will not receive RRT when ECMO is commenced. Only~          when a patient demonstrates AKI and fulfills any one of the criteria of the conventional~          RRT indication during ECMO support or after ECMO weaning, conventional-indication RRT~          would be delivered.~      The primary outcome is all-cause 30-day mortality after ECMO is commenced~   "
53174|NCT02870933|"~     Heart Failure has several etiologies and one of them is coronary artery disease. Coronary~     artery bypass grafting (CABG) is one of revascularizations method which has been used for~     decades in coronary artery disease theraphy. However, data about coronary artery bypass~     grafting shows that post-CABG patients still have low ejection fraction. For the last decade,~     there have been a lot of studies about the using of stem cells to increase heart~     contractility and reverse the heart remodelling process. In this study, we use CD 133+ bone~     marrow stem cells which has been proved to have higher angiogenesis potential. The stem cells~     is given during CABG by injection transepicardial and transseptal. The purpose of this study~     is to determine whether transpicardial and transseptal injection of CD 133+ bone marrow stem~     cells can improve myocardial perfusion in patient with low ejection fraction following CABG~     surgery.~   "
53175|NCT02870920|"~     The standard or usual treatment for this disease is treatment with drugs and other treatments~     that may help to make a patient better or may improve their quality of life. This treatment~     is known as best supportive care (BSC). Although patients with best supportive care can~     feel better for some months, the cancer usually continues to grow.~   "
53176|NCT02870907|"~     Postoperative Treatment of Unilateral Retinoblastoma After Primary Enucleation according to~     histopathological risk factors of the International Retinoblastoma Staging Working Group.~   "
53177|NCT02870894|"~     Evaluation of pulmonary edema is a key factor in monitoring and guidance of therapy in acute~     respiratory distress syndrome (ARDS) patients. To date, methods available at the bedside for~     estimating the physiologic correlate of pulmonary edema, extravascular lung water(EVLW),~     often are unreliable or require invasive measurements. The purpose of the this study is to~     develop a novel approach to reliably assess extravascular lung water by electrical impedance~     tomography(EIT).~   "
53178|NCT02870868|"~     Breathing exercises are categorized as a mind-body practice. One in ten adults in the U.S.~     use breathing exercises for health purposes. The aim of this project is to examine if~     different slow breathing has different physiological and psychological effects.~   "
53179|NCT02870855|"~     Repeated implantation failure（RIF） is a insurmountable bottleneck in assisted reproductive~     technology, many studies have considered that the cause of two-thirds of implant failure is~     the decreased endometrial receptivity. Human chorionic gonadotropin (hCG) is an early~     pre-plant signal molecule secreted by the embryo, it can promote endometrial proliferation,~     increase blood flow and promote embryonic adhesion and inhibit self-regulate apoptosis of~     trophoblast cells. Previous studies showed that: intrauterine injection of HCG before embryo~     transfer can improve clinical outcomes in IVF/Intracytoplasmic sperm injection(ICSI). But~     some studies found that the intrauterine injection of HCG can not significantly improve the~     success rate of blastocyst transfer, and the reason may be the intrauterine injection of HCG~     time is too late to significantly increase the implantation rate. Would ahead of intrauterine~     injection of HCG be more effective? Thus, the patients of repeated implantation frozen embryo~     cycle according to the random principle accepted two kinds of transplants ways: ①intrauterine~     injection of HCG before blastocyst transfer; ②blastocyst transfer. Try to understand whether~     intrauterine injection of HCG can significantly improve the clinical pregnancy rate of~     blastocyst transfer in repeated implantation failure patients.~   "
53180|NCT02870842|"~     Investigators hypothesized that maintaining low fraction of inspired oxygen would be~     beneficial to prevent anesthesia-induced atelectasis in mechanically ventilated children~     undergoing general anesthesia.~   "
53181|NCT02870829|"~     The proposed study will seek to evaluate the prevalence and the progression of vascular~     calcification in a cohort of maintenance hemodialysis patients in Asian population. It will~     also evaluate the efficacy of vitamin K 2 supplementation in reducing the progression of~     vascular calcification in this group of patients.~      This will be a single-center randomized, prospective and open-label interventional clinical~     trial of end stage renal failure patients on hemodialysis.Primary outcome will be absolute~     difference in coronary artery calcium (CAC) score at 18-month between control and~     intervention arms. Secondary outcomes will be to compare absolute difference in aortic valve~     calcification, percentage of patients with regression of coronary artery calcification of at~     least 10%, absolute difference in aortic and systemic arterial stiffness, mortality from any~     cause and major adverse cardiovascular events (MACE) over the same period.~   "
53182|NCT02870816|"~     The purpose of this study is to determine whether amnion membrane grafts are more effective~     than another tissue engineered skin substitute, when used to treat diabetic foot ulcers~     (DFUs).~   "
53183|NCT02870803|"~     Around the world there is an increasing incidence of diabetes mellitus, with millions of~     people affected. In this population, diabetic macular edema (DME) is the most common cause of~     visual impairment. While the visual impairment caused by EMD is variable, its early treatment~     can improve visual acuity and quality of life. The objective of this project is to use the~     new OCT-angiography technology, which evaluates macular capillary network without the need of~     intravenous injection of contrast, to assess macular microcirculatory network in its response~     to intravitreal pharmacological treatment of EMD. The resulting qualitative evaluation can be~     helpful in understanding the pathophysiology of visual loss associated with DME and in~     determining prognosis.~   "
53184|NCT02870790|"~     A new NSW Ministry of Health HIV Strategy released on 1 December 2015 aims for the virtual~     elimination of HIV transmission in NSW by 2020. Critical to the new strategy's success is the~     population-based, targeted roll-out of HIV PrEP. PrEP involves taking one pill daily of~     co-formulated tenofovir disoproxil fumarate (TDF)/ emtricitabine (FTC). This large-scale~     study aims for the rapid roll-out of TDF/FTC to individuals at high risk of HIV, who will~     comprise mostly gay and bisexual men (GBM) but will also include small numbers of~     heterosexuals, injecting drug users, and transgender men and women. The drug will be used~     according to existing NSW Ministry of Health Guidelines. By rapidly rolling out this new~     intervention over a 12 month period, and following participants for two years on treatments,~     a reduction of about 50% in new HIV diagnoses in NSW is expected.~      The study aims to assess the incidence of HIV among PrEP study participants and measure the~     population-level impact of the rapid roll-out of PrEP on HIV diagnoses among GBM in NSW over~     a two-year period.~      It will also evaluate the rate of PrEP uptake among high risk GBM in NSW, assess the~     incidence of STI (gonorrhoea, chlamydia and infectious syphilis) among people prescribed PrEP~     and measure the effect of the rapid roll-out of PrEP on the overall number of notifications~     of gonorrhoea, chlamydia and infectious syphilis in NSW, describe patterns of PrEP use and~     medication adherence, and monitor behavioural risk practices among PrEP users.~      The main population group will be more than 3700 gay men at high risk of HIV infection. All~     procedures of this study are guided by the NSW Guidelines on PrEP.~      Protocol Co-Chairs Professor David Cooper, Professor Andrew Grulich. Project Manager: Barbara~     Yeung~   "
53185|NCT02870777|"~     Acute myeloid leukemia(AML) patients with favorable and intermediate cytogenetics at~     diagnosis are generally excluded from first-line allo-SCT. However, these patients may~     eventually relapse in some of cases. The purpose of this study is to establish risk~     stratification based on cytogenetics and minimal-residual-disease(MRD) analysis to determine~     whether a MRD-directed therapy for low and intermediate AML patients has positive results in~     terms of overall survival.~   "
53186|NCT02870764|"~     This is a randomized, double-blind, placebo-controlled, adaptive clinical trial, which will~     assess the effect of DanshenDuofensuanyan[Danshen (a kind of Chinese herbal drug) extract]~     treatment on Lipoprotein associated phospholipase A2 level in patients with stable angina~     pectoris.~   "
53187|NCT02870751|"~     Heat stable toxin (ST) producing ETEC strains are important causes of childhood diarrhea in~     many countries. Vaccine candidates targeting ST are in development. A human challenge model~     using an epidemiologically relevant enterotoxigenic E.coli (ETEC) strain expressing ST, but~     not other diarrhea inducing toxins like heat labile toxin (LT), is necessary to perform an~     early and efficient evaluation of an ST-toxoid based vaccine.~      In this controlled human infection study the investigators will assess the safety of a~     ST-only producing ETEC strain and the dose needed to achieve an attack rate of 70% in healthy~     human volunteers.~   "
53188|NCT02870738|"~     Women with interstitial cystitis/bladder pain syndrome (IC/BPS) have debilitating urinary~     frequency and urgency, and chronic pelvic or bladder pain perceived to be related to the~     bladder. Although many clinicians think that IC/BPS symptoms result from a bladder problem,~     tight pelvic floor muscles can cause similar symptoms and might be responsible for ICBPS~     symptoms instead of the bladder. Inadequate assessment of the problem leads to delays in~     treatment and often years of suffering. This clinical trial will test a bladder directed~     therapy (bladder instillations) compared to a course of pelvic floor physical therapy (PFPT)~     to assess the role of the pelvic floor as a major contributor to pelvic pain and voiding~     dysfunction in adult women with non-ulcerative IC/BPS. Early assessment of the pelvic floor~     muscles in patients with IC/BPS symptoms may prevent common delays in proper diagnosis and~     allow for early, more effective treatment.~   "
53189|NCT02870725|"~     Having co-occurring depression and chronic headaches is challenging and can greatly impact~     one's professional, personal, family, and social life. People living with chronic headaches~     are often at a greater risk of having comorbid psychiatric disorders (depression, anxiety),~     reduced quality of life, and impaired functioning because of under-diagnosis, misdiagnosis or~     under-treatment of both chronic conditions.~      This study is a pilot clinical trial that will compare the effectiveness of a brief~     cognitive-behavior therapy (CBT) depression intervention to a care as usual (control) group.~     The aim of the study is to determine how well the CBT intervention will reduce the frequency,~     severity and level of disability of both the headaches and depression symptoms.~   "
53190|NCT02870712|"~     During childbirth, the recommendations have evolved to a restriction of episiotomy. This~     reduction results in an increase of superficial vaginal and perineal tears. These lesions are~     usually routinely sutured which often causes the onset of discomfort and pain in the~     immediate postpartum period. Gordon showed, in 1998, improved comfort and pain when the skin~     was not sutured perineal tears during the second degree. Others have compared different~     techniques in the same indications (separated points running suture, biological adhesive)~     without demonstrated impact. These studies were not interested in isolated perineal tears or~     first degree or the application of a simple manual compression with or without a suture~     according to the result of hemostasis.~      Our objective is to evaluate the possibility of not suture the perineum of the first degree.~     The use of suture only result of bleeding not yielding to manual compression.~      Our approach is guided by the principles of primum non nocere and discerning about the~     dogmatic systematization.~   "
53227|NCT02870231|"~     This trial is conducted in the United States of America. The aim of this trial is to~     investigate Safety, Tolerability, PK (the exposure of the trial drug in the body) and PD (the~     effect of the investigated drug on the body) for Multiple Doses of NNC9204-0530 in~     Combination with Liraglutide in Male and Female Subjects being Overweight or with Obesity~   "
53191|NCT02870699|"~     Docetaxel is widely used in oncology for the treatment of many solid tumors. The side effects~     of docetaxel are many and sometimes serious. The primary toxicity of docetaxel is~     neutropenia. Skin and nail manifestations, frequency, the second category of adverse events~     after haematological adverse events.~      Use of the product Evonail® was demonstrated in a patient treated by doxetaxel and having~     nail damage.~      The purpose of this study is to confirm the effectiveness of the film-forming solution~     Evonail® versus a placebo on the prevention of nail damage in women with breast cancer and~     treated by adjuvant docetaxel.~   "
53192|NCT02870686|"~     For endoscopist, ERCP for bile duct stone removal is the most widely performed procedure.~     However, the risk associated radiation exposure to patients and staff are not neglible.~     Earlier studies, ERCP without the use of fluoroscopy has been reported high success for bile~     duct stone removal in pregnant patients to prevent radiation exposure to the fetus. EUS is~     highy accurate technique in detecting common bile duct stone and guiding for therapeutic~     intervention. There has been a few data from literature showed that EUS guided CBD stone (~     CBDS ) removal are equivalent to those following ERCP in term of successful CBDS removal and~     complications. This randomized trial is designed to address the question that EUS guided CBDS~     removal is equivalent to ERCP in term of efficacy and safety.~   "
53193|NCT02870673|"~     In clinical practice, carpal tunnel syndrome (CTS) is the common disease of peripheral~     neuropathy and usually happened to female, mid-age population, overweight persons, and those~     who overused their hands for work or production. Some research claimed this might be~     correlated to anatomical characteristics such as the longer anteroposterior diameter or~     smaller cross section area of the wrist. Preliminary symptoms often start with sensory domain~     (pain, tingling, paresthesia and especially night awakening due to symptoms mentioned above)~     and then progress to motor domain (thenar muscle atrophy and clumsiness) if left untreated.~      Depending on the severity, patient's willingness and convenience, there are many options for~     CTS. For those whose symptoms are mild to moderate, conservative therapies are usually the~     first choice, including physiotherapies, local injection and night splints. Local steroid is~     proven to be effective to relieve the symptoms of CTS shortly up to 3 months. However, the~     effects will decline gradually and repetitive injections is suggestive. The patients with~     severe symptoms which comprise thenar muscle atrophy will be advised to receive decompression~     surgery.the surgery can alleviate the illness with high success rate up to 70%.~     Unfortunately, there are still patients who will relapse or undergo side effects, for~     example, finger weakness.~      In recent years, acupuncture researches focused on CTS intervention have been outgrowing and~     promising. Whereas, there are still lack of evidence which stands for the therapeutic effects~     comparing with local steroid injection. This limits the built-up of suspect mechanism of~     acupuncture intervention for CTS.~      This is a preliminary, randomized and single-blinded study which started since 2016 and last~     for a year. The investigators utilize ultrasound to guide the depth of needle penetration~     which prevents unnecessarily tissues injury such as artery or dry needle injury. This~     procedure also guarantees the needles lie directly on the upper surface of the median nerve.~     One group will receive electrical stimulation and another won't. The investigators use~     electromyography, cross-section area of median nerve, visual analog scale, Boston Carpal~     Tunnel Syndrome Questionnaire, six-item scale, The disabilities of the arm, shoulder and hand~     score and Jamar grip dynamometer as outcome measurements. The results gathered from two~     experimental groups will be compared with the data from the control group whose participants~     only receiving local steroid injection once in the first week. The participants are all above~     18 years old and complain of illness for a least 3 months without any surgery or local~     injection for a least 1 year. The investigators set up strict exclusive criteria and sample~     size estimation is 70.~   "
53194|NCT02870660|"~     Familial hypercholesterolemia (FH) is a most prevalent genetic disorder, defines as high~     cholesterol level and premature death. The prevalence of FH has been reported in few~     countries however unknown in Iran. Thus recognize the FH patients, determine the diagnostic~     strategies and appropriate treatments are important.~      Also acute coronary syndrome (ACS) is a group of conditions which arises from reduction of~     blood flow in coronary arteries. Three specific conditions are included: ST elevation~     myocardial infarction, non ST elevation myocardial infarction and unstable angina. Premature~     ACS defined by occurrence of ACS<55 for men and ACS<60 for women. Studies demonstrated direct~     connection between familial hypercholesterolemia and occurrence of premature ACS.~     Investigators intent to detection of FH amongst patients with acute coronary syndrome.~   "
53195|NCT02870647|"~     Prospective, international, non-randomized, multicentre, clinical investigation (phase IV).~     The aim of the study is to investigate the correlation between HF, severe SBD, and AF in~     CRT-P patients at 6 months.~   "
53196|NCT02870634|"~     Multicenter, open-label , single and multiple dose-escalation and pharmacokinetic study~   "
53197|NCT02870621|"~     The perirenal fat may alter renal function by secreting fibrotic inflammatory agents when~     accumulates during obesity. Nephrectomy for renal tumor is a model that would provide tissue~     samples to test this hypothesis. Renal tumor could itself be responsible for inflammation and~     fibrosis in its environment. This study aims to measure the influence of the tumor on his~     kidney Environment and fat and define molecular markers not influenced by renal tumor. The~     main objective is to compare the inflammation of the perirenal fat taken in two locations in~     the same patient, in contact and 4 cm from the outer edge of the tumor, each patient as his~     own control. The secondary objective is to compare the degree of interstitial fibrosis of the~     renal cortex in the same sampling methods.~   "
53198|NCT02870608|"~     The objective of the study was to evaluated the feasibility and reproducibility of the~     measurement of lung elasticity report / fetal liver according to gestational age in a group~     of patients with a normal course of pregnancy and in a group of Patients at risk of preterm~     delivery.~   "
53199|NCT02870595|"~     The investigators hypothesize that patients who receive 1% lidocaine injections for digit~     blocks of the finger will experience less pain when the injection is accompanied by the use~     of a micro-vibratory stimulator (MVS) compared with patients who receive injections without~     the MVS.~   "
53200|NCT02870582|"~     The investigators do the clinical trial (patients with metastatic colorectal cancer treated~     with donafenib/placebo after failure of standard therapy) to assess efficacy and safety of~     donafenib in patients with metastatic colorectal cancer, progressing after all approved~     standard therapies.~   "
53201|NCT02870569|"~     Donafenib for advanced 131I-refractory/resistant differentiated thyroid cancer(DTC).~   "
53202|NCT02870556|"~     Pharyngocutaneous fistula (PCF) is the most commonly reported postoperative complication in~     total laryngectomy patients. PCF significantly increases morbidity, length of~     hospitalization, and cost of care, in addition to delaying the beginning of adjuvant therapy.~     The reported incidence of PCF ranges from 3% to 65%.The increased use of radiation in the~     primary management of laryngeal carcinoma has resulted in an increase in the PCF formation~     after salvage laryngectomy (STL).~      Previously reported risk factors for PCF development include preoperative radiotherapy, tumor~     stage, concomitant neck dissection, prior need for tracheotomy, hypoalbuminemia and anemia.~      Among surgical options, the pectoralis major myofascial flap has been proposed to cover the~     pharyngeal closure, to interpose non-irradiated tissue between the neopharynx and the skin~     during STL. Nonetheless, the efficacy of this approach is not fully established.Epidural~     anesthesia improves the blood supply due to its vasodilating effect. The aim of the study is~     to evaluate the effect of perioperative cervical epidural analgesia on the occurrence of~     pharyngocutaneous fistula following salvage laryngectomy and reconstruction with pectoralis~     major myocutaneous flap.~   "
53203|NCT02870543|"~     This study aims to evaluate, through a crossover, controlled, double-blind and randomized~     clinical trial, the efficacy of Phytolacca decandra in association or not with Melissa~     officinalis in the treatment of children with nocturnal bruxism. Children from 3 to 12 years~     old with nocturnal bruxism will be randomly allocated into different groups of treatment~     stage as follows: (1) placebo; (2) Phytolacca decandra; (3) Melissa officinalis; (4)~     Phytolacca decandra associated with Melissa officinalis. All children will participate to~     each clinical stage, with a period of 14 days of whashout. Children and the principal~     investigator will be masked to treatment. The efficacy will be evaluated through parents~     report about the absence of tooth clenching or grinding by children and electromiography~     exams. The secondary outcomes that will be evaluated are: trait anxiety and quality of life~     related to oral health.~   "
53204|NCT02870530|"~     The purpose of this study is to determine the efficacy of of gastric bypass without gastric~     division as a treatment for morbid obesity~   "
58196|NCT02805140|"~     The purpose of this study is to test feasibility and acceptability of an online platform that~     uses mobile apps and videoconferencing tools to increase activity levels in mothers with~     young children.~   "
53205|NCT02870517|"~     The purpose of this study is to assess the effect of music, played prior to a surgical~     procedure, on stress levels during induction of anesthesia. Hypothesis: playing calming~     music, pre-selected by the investigator and the patient, beginning just prior to induction~     and terminating after induction will positively reduce the patient's heart rate, blood~     pressure, and respiratory rate during this period. For this study, noise-cancelling~     headphones with the ability to play music via an iPod will be utilized.~   "
53206|NCT02870504|"~     Glaucoma is the second cause of blindness worldwide. Laser peripheral iridoplasty (LPI) is a~     simple and effective treatment for angle closure glaucoma. LPI can widen or reopen an~     existing angle close or angle adhesion in order to reduce the risk of attack of the angle~     closure glaucoma. However, there are very little research on the laser site, laser~     wavelengths, laser energy and laser spot intervals. The purpose of this study is to determine~     the optimum laser site of LPI.~   "
53207|NCT02870491|"~     The purpose of this study is to assess how free distribution and preemptive home delivery of~     oral rehydration salts (ORS) by community health workers affects ORS use. The investigators~     will measure the impact of the combination of the two interventions (free distribution +~     pre-emptive home delivery) as well as the impact of each intervention separately (free~     distribution without home delivery and pre-emptive home delivery without free distribution).~   "
53208|NCT02870478|"~     The purpose of this study is to determine whether less frequent dosing of atropine drops may~     be as effective as daily dosing for the treatment of progressive myopia.~   "
53209|NCT02870465|"~     The main objective of this non-interventional, observational study is to analyze the rate and~     type of infection complications while performing closed reduction internal fixation (CRIF) of~     hand fractures in the operating room versus an ambulatory setting. The investigators will do~     so by prospectively collecting data on the type of fracture, handedness, co-morbidities,~     duration of treatment, number and type of K-wires, duration of fixation and complication~     rate. Patients presenting with hand fractures to the emergency room will be recruited.~     Patients will be recruited in multiple centres across Canada and managed according to the~     institutional standard. The complication type and rate will be recorded and analyzed to~     determine a difference of performing the procedure in the operating room or clinical setting.~   "
53210|NCT02870452|"~     The purpose of this study is to evaluate the relative effectiveness of two psychological~     interventions, cognitive-behavioral therapy (CBT) and hypnosis (Hyp), in preventing and~     managing pain, regulating emotional state and improving quality of life in Portuguese PWH.~   "
53211|NCT02870439|"~     Burn injury with full-thickness skin damage that encompass large body surface areas can~     induce local and systemic perturbations that are costly in terms of human suffering as well~     as in strains on the health care system. Characterization of new major molecular biomarkers~     involved in this process creates significant diagnostic and therapeutic challenges.~      Hypoxia-inducible factor-1 α (HIF-1 α) is a ubiquitously expressed heterodimeric~     transcription factor comprising an α and a β subunit. It was shown that under normoxic~     conditions, the HIF-1α subunit is ubiquitinated and degraded, whereas under hypoxic~     conditions, HIF-1α accumulates, dimerizes with HIF-1β, and activates the transcription of a~     spectrum of target genes encoding multiple angiogenic growth factors and cytokines of~     potential importance in wound healing. Seven isoforms of HIF-1α issued from alternative~     splicing have been identified.~      The importance of HIF-1α in wound healing in animal models has been suggested by several~     studies. Indeed, diminished HIF-1 levels and activity have been documented in conditions of~     impaired wound healing. The literature review shows a marked reduction of HIF-1α levels in~     mice in case of burn wound skin that in the case of excisional cutaneous wound. Other studies~     have shown that the expression of HIF-1α was correlated with the extent and depth of the~     burns.~      This study aims to improve the knowledge on the pathophysiological factors involved in the~     field of wound healing. The assumptions are based on results of studies done on mice, and~     this work aims to document these findings in humans.~      Objective~      The main objective of the study is to compare the variations of expression of HIF-1α measured~     in blood and skin tissue samples in three groups:~        -  Subjects with major burn wounds involving more than 20% of the total body surface area;~        -  Subjects with burn wounds smaller than 5% of total body surface area;~        -  Subjects with a skin wound after a surgical procedure requiring a skin resection.~      Secondary objectives are to compare the expression levels of HIF-1α locally at the burn site~     to those observed in blood, to evaluate the expression of growth factors produced by HIF-1α~     target genes (VEGF and EPO) or playing a central role in the healing process (TGF-β1), and to~     assess the correlation between the expression of HIF-1α and the kinetics of wound healing of~     the subject rated by evaluation of time of donor sites complete epithelialization.~      Material and Methods~      We propose to create three groups:~        -  15 patients with extensive third degree burns involving more than 20% of the total body~          surface area;~        -  15 patients with less extensive third degree burns, involving less than 5% of body~          surface area;~        -  15 patients with post-surgical wounds with skin resection. Skin and tissue specimens~          will be collected three times: day 0, 7 and 14 from burned patients (with more than 20%~          of the total body surface area and less than 5% of body surface area). Samples of skin~          tissue will be collected within the skin resection from patients with post-surgical~          wounds at day 0, blood samples will be collected at day 0 and 14.~   "
53212|NCT02870426|"~     We aim to retrieve olfactory bulbs (OBs) from suitable human donors. We have defined two~     groups who will qualify:~      Group 1 - Deceased Donors:~      1A: Donors after brainstem death (DBDs) undergoing solid organ donation~      1B: Donors after brainstem death (DBDs) considered unsuitable for solid organ donation~      Group 2 - Living Donors:~      Neurosurgical patients undergoing anterior cranial surgery in which the olfactory nerve (ON)~     is cut as part of the surgical procedure. The OB of the concomitant severed ON would be~     donated.~      We aim to optimise OB collection and Olfactory Ensheathing Cell (OEC) culture and storage. We~     will study the effects of patient diagnosis, age, cause of death (if applicable),~     co-morbidities and warm ischaemic time on cell survival and regenerative function.~      In future studies we aim to store OECs in a GMP facility and transplant OECs into patients~     with spinal cord injuries.~   "
53213|NCT02870413|"~     The investigators will conduct a randomized controlled trial (RCT) to generate data on the~     impact of direct-to-consumer telelactation (virtual breastfeeding support) services.~     Postpartum mothers age 18 and older who have initiated breastfeeding will be recruited at a~     critical access hospital without access to IBCLCs in rural Pennsylvania and randomized into~     two study arms: 1) outpatient telelactation services via video calls on personal devices or~     2) usual care. Data on breastfeeding duration and exclusivity, as well as perceptions and~     satisfaction with breastfeeding, will be captured via surveys and in-depth interviews and~     compared across groups.~   "
53214|NCT02870400|"~     The primary objective of the study is to assess the safety and tolerability of single~     ascending doses of REGN2477 in healthy women not of childbearing potential.~   "
53215|NCT02870387|"~     The investigators will conduct a pilot quality improvement trial to assess the impact of~     offering inpatient consultation to further optimize coordination and improve care for~     high-risk chronically ill children receiving comprehensive care in an enhanced medical home.~   "
53216|NCT02870374|"~     The project team developped and validated a French patient-based health-related quality of~     life instrument in kidney transplant: the QoL Retrans.~      The aim of the study is to determine the minimum significant change of the valdiated tool:~     ReTransQol~   "
59342|NCT02790112|"~     This study evaluates the influence of early adiposity rebound, genetic polymorphisms and~     GnRHa treatment on long-term outcome of girls with idiopathic central precocious puberty.~   "
53217|NCT02870361|"~     Insulin resistance is a central pathophysiological component of type 2 diabetes and is~     associated with a high risk of cardiovascular disease. The tissue in which it manifests are~     mainly muscle, liver, and adipose tissue. Since the transport of glucose to the brain is~     independent of insulin, this organ has traditionally not been studied in this regard. In~     animal experiments, however, knockout of the insulin receptor in the brain leads to obesity~     and peripheral insulin resistance. This finding of insulin action in the brain could also be~     confirmed in human studies.~      The investigators intend to investigate whether central nervous insulin action affects~     insulin secretion in humans. For this purpose, nasal insulin and placebo are administered 15~     minutes before a hyperglycemic hyperinsulinemic clamps, which stimulate insulin secretion.~     Insulin sensitivity of the brain is measured by a an established protocol with functional~     magnetic resonance imaging before and after nasal insulin administration.~   "
53218|NCT02870348|"~     This is a multi-center, open-label study to evaluate the long-term safety of weekly IV~     infusions of 60 mg/kg Alpha-1 MP in adult subjects with AATD in Japan who have completed~     Study GTI1401.~   "
53219|NCT02870335|"~     Introduction: Field hockey is a contact sport. Semiflexion asymmetric position, along with~     other theories such as the weakness of the extensor muscles of the back or hamstring injury,~     can be causes or aggravating that suelan hockey players suffer back pain. Objectives: To~     observe the effectiveness of manual therapy techniques and post-isometric stretching (PNF)~     after three treatment sessions. In turn, know which of the two treatments have a greater~     benefit and longer. Methods: The population consists of grass hockey players and senior~     category aged between 16-30 years. They were randomly divided into two treatment groups.~     Group 1 corresponded to manual therapy techniques and group 2 to PNF stretching. The study~     duration for each subject was 5 sessions that included 3 treatment and 3 assessments. Each~     evaluation consisted of goniometry, balance test using the Sit and Reach, and Roland Morris~     questionnaire.~   "
53220|NCT02870322|"~     This research will use randomized controlled trial (RCT) methodology to assess the~     feasibility of a prescription for fruit/vegetable CSA shares or exercise by bikeshare on~     obesity-related outcomes. Three cohorts of n=10 University of Wisconsin-Madison (UW) students~     (total 30) will be randomized to three groups: (1) a 10-week fruit and vegetable community~     supported agriculture (CSA) share prescription program with vegetable education and cooking~     support from UW Slow Food; (2) a 10-week Madison B-cycle bikeshare membership prescription~     program with exercise support or (3) a non-interventional wait-list control group. The~     primary outcome will be change in Body Mass Index (BMI) (a measure of obesity using a~     person's weight in kilograms divided by his or her height in meters squared). Secondary~     outcomes will be fasting lipids, blood pressure, and glycated hemoglobin (HGA1c) levels. All~     of these measures will be tested at baseline and just after the 10-week intervention~   "
53221|NCT02870309|"~     This study is a multicenter, open-label trial to evaluate the safety and pharmacokinetics of~     weekly intravenous infusions of 60 mg/kg of Alpha-1 MP for 8 weeks.~   "
53222|NCT02870296|"~     The primary study goal is to improve the quality of care transitions for patients with new~     episodes of venous thromboembolism (VTE).~      Primary Outcomes: To measure differences in the quality of care transition, as measured by~     the Care Transition Measure (CTM)-15 in the investigators target population of patients with~     incident VTE randomized to either a multicomponent, anticoagulation medical home intervention~     or usual care.~      Secondary Major Outcomes: To measure the difference in recurrent VTE, major hemorrhage,~     all-cause re-admissions, and mortality between the investigators intervention and comparison~     groups at 30 and 90 days in the investigators target population.~      Secondary Other Outcomes: To measure patient knowledge, health-related quality of life, and~     time in the therapeutic range (TTR) for patients on warfarin in the investigators target~     population.~   "
53223|NCT02870283|"~     To evaluate the effectiveness of three systematic interventions for Bipolar Disorder (BD)~     mixed episodes using medications available in the Brazilian Public Healthcare System (SUS),~     and assessment of the quality of life of these patients.~      A randomized pragmatic trial was conducted. An algorithm was developed for the treatment of~     episodes of bipolar mixed episodes.~   "
53224|NCT02870270|"~     Radiation therapy (RT) leads to a markedly reduced salivary secretion rate, which makes it~     difficult to eat and talk and it is a risk factor for oral disorders such as caries and~     mucosal infections. A reduced salivary secretion rate is often a life long side-effect of the~     treatment that seriously affect the quality of life. To reduce these side-effects the~     patients get preventive and supportive oral treatment in connection with their cancer~     treatment. However, regardless of radiation doses given, the severity of the problems vary~     considerably. Therefore, a better understanding on when and why problems occur is important~     for the identification of subjects at risk and to find better measures and treatments, suited~     for their individual needs.~      Dentate subjects were included referred before RT. Data were collected before and during~     treatment as well as 6, 12 and 24 months after completed RT. Cancer diagnosis, treatment,~     radiation doses, infections and medication were obtained from medical records.~      Dietary habits were registered using a questionnaire focusing on intake of carbohydrate-rich~     food-items and items containing sugar-substitutes. The subjects weight was registered before,~     during and after RT.~      A clinical examination was performed before and 6, 12 and 24 months after completed RT.~     Panoramic x-rays were taken as well as bitewing radiographs. The number of teeth, caries~     status, oral hygiene were registered. Mucositis was registered during RT.~      Secretion of stimulated whole saliva was determined. Minor labial and buccal gland saliva~     secretion rate was determined using the Periotron-method. Microbial samples were collected~     from the tongue, buccal mucosa and supragingival plaque and microorganisms associated with~     oral health and oral disorders analysed using cultivation technique.~      The quality of life was registered using the questionnaires EORTC QLQ-C30 (European~     Organization for Research and Treatment of Cancer Quality of Life Questionnaire). To address~     additional symptoms associated specifically with cancer in the head and neck region and its~     treatment, a complementary 35-item module, the EORTC QLQ-H&N35 was used.~      The patients also completed the Hospital Anxiety and Depression Scales, HADS, which is used~     to measure severity of anxiety and depressive symptoms and provides estimates of possible~     mood disorders in patients with somatic comorbidity.~   "
53225|NCT02870257|"~     Seventy subjects with shoulder impingement syndrome associated with scapular dyskinesis will~     be recruited and randomized into two groups of treatment. The group a will receive a~     strenghtening protocol with progressive overload during 20 sessions and group b will~     receive the same protocol with minimal load, without change during the 20 sessions. The~     primary outcomes measures will be pain, function, quality of life, global impression of~     recovery. The change will be measure from baseline at 10 weeks (after 20 sessions), 3 and 6~     months (follow-up). The secundary outcomes will be disability, quality of life measure by~     other instruments, shoulder muscle strength and scapular 3d kinematic variables. For these~     data, change will be measure from baseline at 10 weeks (after 20 sessions).~   "
53226|NCT02870244|"~     Phase I clinical trial to determine the Phase II dose of autologous TIL 1383I TCR gene~     modified T Cells using a retrovirus. This is a novel National Cancer Institute (NCI) funded~     investigator initiated therapy for patients with advanced melanoma.~   "
53228|NCT02870218|"~     Three hundred-twenty (320) adult smokers of menthol or non-menthol combustible cigarettes~     will be recruited and randomly assigned to one of five groups (n=64/group), who will be asked~     to switch for 12 weeks to ad libitum use of combustible cigarettes (matched to subjects'~     menthol preference) containing either 0.4, 1.4, 2.5, 5.6 or 16.9 mg nicotine (standardized~     nicotine yields ranging from 0.02-0.80 mg/cigarette), respectively. Each group will include~     32 heavy, long-time smokers (≥ 10 cigarettes/day for ≥ 10 years), and 32 light smokers with a~     shorter smoking history (<10 cigarettes/day for <10 years), who are hypothesized to be more~     sensitive to nicotine's reinforcing effects. Participants will also have free access to~     nicotine-containing e-cigarettes (15 mg/ml) throughout the 12-week period. Abuse liability of~     combustible cigarettes will be assessed by behavioral (cigarettes/day, time to first~     cigarettes), self-report (rewarding effects, withdrawal symptoms) and biochemical indices~     (expired air carbon monoxide, cotinine blood sampling).~   "
53229|NCT02870205|"~     Study to evaluate the efficacy, safety and tolerability of GSP 301 NS compared with placebo~     NS and individual monotherapy formulations for the treatment of Seasonal Allergic Rhinitis~     (subjects 12 years of age and older)~   "
53230|NCT02870192|"~     Outcomes of laparoscopic ventral mesh rectopexy are well known, but data on intra-operative~     adverse events is scant. A multicenter pool-analysis of prospectively collected database on~     1384 patients with internal/external rectal prolapse toke place. Overall 72 (5%) patients~     experienced complications, 41 discovered and managed intraoperatively, 22 postoperative~     complications, and 9 required readmission. Despite accepted lower rate of morbidity, these~     results come from four well equipped European centers by four surgeons practiced at least 200~     LVMR.~   "
53231|NCT02870179|"~     The purpose of this study is to conduct a SpO2 hypoxia evaluation of the Oxitone Medical~     Oxitone 1000 pulse oximeter. The Oxitone 1000 pulse oximeter will be evaluated during~     non-motion conditions over the range of 70-100% SpO2 in comparison to a Reference Pulse~     Oximeter.~      The study is observational in nature which quantifies device performance and accuracy in~     compassion to a Reference Pulse Oximeter.~   "
53232|NCT02870166|"~     Given the structural essential, catalytic and co-catalytic played by zinc in many sections of~     protein metabolism, carbohydrate and lipid (zinc is involved in the function of more than 300~     metalloenzymes and metalloproteins), one can imagine the impact of a deficiency or even a~     sub-chronic zinc deficiency on the health of the individual. Studies multiply that show that,~     long-term, marginal zinc deficiency is a risk factor for the development of cancer or~     neurodegenerative complex diseases (eg Alzheimer's disease). In addition, the short-term zinc~     deficiencies foster the development of skin conditions and susceptibility to viral and~     bacterial infections. The aim of this project is to identify, in the population of patients~     with pseudo-acrodermatitis enteropathica (AE) tested in the investigators laboratory, rare~     variants (mutations real epimutations or polymorphisms) located in solute carrier family 39~     member 4 (SLC39A4) gene or in 55 other genes chosen for their role in zinc homeostasis.~   "
53233|NCT02870153|"~     The aim of this study is to compare the activity and safety of Oxaliplatin and S-1 (SOX) and~     Oxaliplatin and Capecitabine (XELOX) in patients with peritoneal metastasis of colorectal~     cancer.~   "
53234|NCT02870140|"~     The primary objective of this study is to compare the performance of SUPRAFLEX to that of~     XIENCE in an all-comers patient population with symptomatic ischemic heart disease. The~     patients will be followed through 3 years for major clinical events.~   "
53235|NCT02870127|"~     The existence of a family factor in the genesis of varicose veins is certain, but few studies~     have addressed reliably instead of the genetic factor in clinical and molecular level. The~     investigator initiated an original study to identify one or more genetic abnormalities~     predisposing to varicose disease, based on a combined approach of genetic linkage and of~     exome sequencing. The clinical research phase is an essential prerequisite to the~     identification of genetic mutations; it is to identify large affected families and ensure an~     extremely rigorous and accurate phenotyping of individuals over several generations. A first~     clinical work has identified and / or phenotype 8 families with a genetically informative~     family suggesting autosomal dominant inheritance. Linkage analysis suggested several~     candidate chromosomal regions without allowing the identification of a gene. This project~     aims to resume and expand the Family clinical investigations and apply the techniques of~     genome analysis points, including exome sequencing on the most informative families to~     identify the genes and mechanisms responsible of this disease and improve the prevention and~     the treatment of varicose veins.~   "
53236|NCT02870114|"~     The purpose of this study is to implement a national survey to collect information regarding~     Portuguese people with haemophilia (PWH) on socio-demographic, clinical and psychosocial~     factors.~   "
53237|NCT02870101|"~     The purpose of this study is to provide data and analyses to support 510(k) applications to~     the FDA for multiple nucleic acid amplification tests (NAATs) diagnostic platforms.~   "
53238|NCT02870088|"~     The purpose of this project is to investigate the effect of breaking prolonged sitting on~     acute adipose tissue and metabolic responses.~   "
53239|NCT02870075|"~     The purpose of this study is to investigate whether dietary conditions (fed versus fasted)~     affects the acute responses to exercise.~   "
53248|NCT02869958|"~     It is recommended that patients with asthma owned a written action plan which must include~     the names, doses and dosing of the treatment they should take when acute respiratory symptoms~     occur.~      Current written action plans must be short to be readily used (1 page) and, therefore, cannot~     fit all acute situations. Moreover, they may not be available where and when required.~      The investigators sought that a digital action plan, available through Smartphone or tablet~     computer connected to the internet, could adequately provide suitable action plans according~     to the severity of the described exacerbation, and would be more easily available when~     useful.~      The aim of the study is to study the effect of the use of a digital action plan for asthma~     exacerbation, on the frequency of unscheduled medical contacts (phone calls, visits to~     physicians or to emergency departments, hospitalizations) in children and in adults with~     asthma. The investigators hypothesized that the use of the digital action plan could reduce~     avoidable unscheduled visits due to mild or moderate exacerbations that could successfully be~     managed by the patient or his/her caregivers.~   "
59438|NCT02788864|"~     The purpose of the study is to assess if the antimalarial drugs Dihydroartemisinine +~     Piperaquine (DP) are effective in preventing malaria infection for forest ranger~   "
53240|NCT02870062|"~     The search for preventive measure with daily bathing with chlorhexidine in the critical care~     patient will result in a reduction in patient colonization with multidrug resistant~     pathogens. Thus, preventing healthcare associated infections. The aim of this study was to~     determine the impact of daily bathing with chlorhexidine in patient colonization, environment~     and healthcare workers in the medical intensive care unit (MICU).~      The study will be conducted at the University Hospital Dr. José Eleuterio González, a~     450-bed teaching hospital in Monterrey, northeast Mexico.~      This is a prospective, experimental, randomized, open-label, double blind study comparing~     chlorhexidine versus placebo. Any patient 18 years or older admitted to the MICU or with less~     than 48 hours of patient-days will be included. Patients who present burns with more than 20%~     body surface, pregnant patients and patients with allergy history to chlorhexidine.~      Samples will be obtained from the patient, patient environment and healthcare personnel.~      Sampling of the environment (bed rail, mechanical ventilator, table adjacent to the bed,~     etc.) and patient's anogenital and pharyngeal region will be collected with swabbing~     technique using cotton swabs and cultured according to Public Health England.~      Patient skin sampling will be obtained from anorectal region, pharynx, axillary and inguinal~     fold collected with Williamson-Kligman technique. Colonies will then be further selected and~     properly cultivated according to their characteristics. Antibiotic susceptibility, clonal~     relationship, biofilm index and antibiotic susceptibility to chlorhexidine will be~     determined.~      Demographics and clinical data will be collected from admission, throughout hospitalization~     and discharge.~   "
53241|NCT02870049|"~     The purpose of this study is to determine whether inreach and outreach strategies will be~     superior to usual care, and combination of both will be superior to either strategy alone.~   "
53242|NCT02870036|"~     This study evaluates the safety, tolerability, preliminary efficacy and pharmacokinetics of~     Simmitecan in patients with advanced solid tumors and Simmitecan, 5-fluorouracil and~     Leucovorin Calcium,thalidomide in patients with advanced solid tumor or advanced/metastatic~     colorectal cancer.~   "
53243|NCT02870023|"~     Introduction: Multiple sclerosis (MS) is characterized by decreased strength and motor~     control, and compromised gait function. Reduced walking speed, balance, and fatigue are the~     cardinal symptoms. In rehabilitation, strength and balance training are commonly used. There~     is increasing scientific support of strength training for improving walking function. The~     evidence for balance training remains flawed. It is known that neurological damage in MS~     leads to increased cognitive processing in the planning of movements, which predisposes~     fatigue. Since fatigue is also associated with impaired balance, it can be hypothesized that~     motoric/balance training with an emphasis on cognitive load can affect gait and fatigue.~      Purpose: The aim of the study is to determine whether there is a differentiated effect~     between strength and balance training measured by motor function, strength, balance, and~     fatigue.~   "
53244|NCT02870010|"~     Chemoembolization is a recognized treatment strategy for hepatocellular carcinoma (HCC)~        -  classical chemoembolization consists in injecting an emulsion of an anticancer agent in~          Lipiodol® via the hepatic artery~        -  doxorubicin, an anthracycline, is the most frequently used drug in lipiodol~          chemoembolization (LCE)~        -  however, less than half of HCC respond favourably to classical lipiodol~          chemoembolization (LCE) with doxorubicin/Lipiodol®~      In this trial, we propose to introduce in clinical practice a strategy based on idarubicin to~     achieve a more effective antitumor effect for the following reasons, recently pointed out by~     our team:~        -  idarubicin is an anthracycline that penetrates tumour cells more quickly and is more~          cytotoxic than doxorubicin on hepatocellular carcinoma cell lines~        -  idarubicin is injected in a solution of embolization microspheres of a diameter of~          (300-500µm), which all the progressive and controlled release of the anticancer drug,~          whereas the doxorubicin/Lipiodol® emulsion is unstable~   "
53245|NCT02869997|"~     The aim of this study is to evaluate the prognostic value of the suppression ratio monitored~     by Bispectral Index for prediction of neurologic outcome after cardiac arrest. All patient~     admitted to our intensive care unit after a cardiac arrest are included. The results of the~     suppression ratio will be collected in the 6 first hours of admission. We will evaluate the~     link between suppression ratio and cerebral performance category score collected at three~     months.~   "
53246|NCT02869984|"~     Poor functional outcomes has been reported inevitably, and up to 90% of the patients have~     experienced bowel habit changes after sphincter-saving surgery for rectal cancer. But,~     currently there has been no specific treatment for ARS and symptom based empirical management~     is tried Recently, 5-HT3 receptor antagonists can be used for treatment of IBS-D, and has~     been revealed to be slowing the bowel movement and improving stool consistency and urgency.~      We performed the clinical trial with using ramosetron (Irribow®) for the treatment of ARS~   "
53247|NCT02869971|"~     The primary objective of this trial is to compare the 9-month effect on lower urinary tract~     symptoms (LUTS) of Prostatic Artery Embolization (PAE) using Embosphere® versus Standard~     Combined Therapy (alpha-blockers plus 5 alpha-reductase inhibitors) in patients with~     symptomatic BPH who failed after a first line medical treatment with alpha-blockers.~      The secondary objectives of this study are to:~        -  Estimate the impact of the 2 strategies on benign prostatic hyperplasia specific Health~          Status (i.e. urinary and sexual signs and symptoms) at 3, 9, 18, and 24 months, as well~          as the side effects of the 2 strategies;~        -  Report the safety of PAE;~        -  Evaluate patient's adherence to medical treatment;~        -  Analyse the costs of each strategy and report the incremental efficiency (incremental~          cost utility ratio) of prostatic artery embolization compared to medical treatment.~   "
53259|NCT02869815|"~     The value of sentinel lymph node biopsy (SLNB) in patients underwent neoadjuvant chemotherapy~     is controversial. Lower detection rate and higher false negative rate are the main problem.~     The purpose of this study is to determine the detection rate and the false negative rate of~     SLNB by indocyanine green (ICG) in addition to blue dye (methylene blue) after neoadjuvant~     chemotherapy in patients with large or locally advanced breast cancer. This is a single arm~     clinical trial.~   "
53288|NCT02869438|"~     The purpose of this study is to investigate the onset and maintenance of effect of~     benralizumab on lung function, blood eosinophils, asthma control metrics and quality of life~     during 12-week treatment in patients with uncontrolled, severe asthma with eosinophilic~     inflammation. A subset of patients will take part in body plethysmography substudy to further~     investigate the effect on lung function.~   "
53249|NCT02869945|"~     Parkinson's disease onset is clinically defined as the appearance of motor symptoms including~     akinesia, tremor and hypertonia. Several studies have shown that motor symptoms occur when at~     least 50 % of dopaminergic neurons are lost. However, there are evidence suggesting that the~     level of dopaminergic denervation is not homogenous at the time of diagnosis.~      Some patients have a higher level of dopaminergic loss at disease onset indicating the~     existence of compensation mechanisms. The aim of this study is to decipher how the metabolism~     of dopamine is involved in this compensation with a focus on the polymorphism of the COMT~     gene. This gene is expressed according to two variant: (i) COMT H that encodes a form of the~     enzyme with a high level of activity and (ii) COMT L that encode a form of the enzyme with a~     low level of activity. Thus, there are 3 possible genotypes in the population: (i) COMT HH~     associated with an increased degradation of dopamine, (ii) COMT LL associated with a~     decreased degradation of dopamine and (iii) COMT HH (intermediary between COMT HH and COMT~     LL).~      The hypothesis is that this polymorphism of the COMT gene may participate to compensation~     mechanisms in early PD. Patients with COMT HH genotype may have an earlier motor symptoms~     onset than patients with COMT LL genotype.~      To test this hypothesis, we will recruit 51 patients with de novo PD will be recruited (17~     patients for each genotype). Given the distribution of COMT polymorphism in the population, a~     maximum sample of 76 patients will be screened to recruit 17 patients for each genotype.~      Clinical evaluation will include MDS-UPDRS, Non Motor Symptoms Scale, segmental symptoms~     scale, Montreal Cognitive assessment, MMSE, Frontal assessment battery and Parkinson's~     disease behavioral assessment scale (ECMP). All the patients will have a monophotonic~     emission tomography with I-123-Ioflupane in order to assess the level of dopaminergic~     denervation and an MRI scan with resting state study. Cerebrospinal fluid sampling will be~     optional and will allow direct measurements of dopamine metabolites.~      The main outcome measure will be the level of dopaminergic denervation on I-123-Ioflupane~     scans according to COMT genotype, age, gender and severity of motor symptoms on the MDS-UPDRS~     part 3.~      If this hypothesis is confirmed, this will allow to test the efficacy of COMT inhibitors in~     order to delay dopaminergic drugs initiation for PD patients.~   "
53250|NCT02869932|"~     The strategy of neonatal screening for Cystic Fibrosis in France relies on Immuno Reactive~     Trypsinogen (IRT) at day 3/DNA analysis with a CF Elucigen 30 mutations kit/ IRT safety-net~     at day 21. This strategy has significantly improved the performance of CF neonatal screening~     (NNS) in terms of positive predictive value and sensitivity but revealed new difficulties. Up~     to 85-90% of CF patients detected through the NNS program has a classical CF form with a~     positive sweat test and 2, 1 or no CF causing mutations but the remainder has either 2 CFTR~     mutations with at least one non-CF causing mutation and a sweat test <60mmol/L or 1, 0 CFTR~     mutation and an intermediate sweat test value ≥ 30 et < 60mmol/L raising a diagnosis and~     prognosis dilemma. Meanwhile the vast majority of these cohorts will remain asymptomatic over~     time, some will develop symptoms prompting clinicians to maintain a rigorous surveillance for~     the entire atypical cohort, whose modalities vary a lot among centers and countries.~      This prospective multicenter study with a standardized assessment of a matched cohort with~     atypical CF versus classical CF from 6 years of age (60-65 cases in each cohort) is aimed~     at evaluating pulmonary and nutritional status to, better define the best monitoring~     follow-up, therapeutic management and familial genetic counseling.~   "
53251|NCT02869919|"~     This study aims to investigate whether there is a difference in Vitamin D levels between~     critically ill adult patients with and without acute kidney injury.~   "
53252|NCT02869906|"~     Functional assessment of non-culprit lesions during percutaneous coronary intervention (PCI)~     in patients with acute coronary syndrome could improve risk stratification and shorten the~     duration of hospital stay by decreasing the need for additional non-invasive stress testing~     to detect residual myocardial ischemia. The investigators aimed to assess the reliability of~     the instantaneous wave-free ratio (iFR) and fractional flow reserve (FFR) measurements in~     non-culprit coronary lesions during the acute and subacute phase of ST-segment elevation~     myocardial infarction (STEMI).~   "
53253|NCT02869893|"~     The goal of this research study is to learn more about the pancreas. The investigators want~     to use Magnetic Resonance Cholangiopancreatography (MRCP) to learn more about the size of a~     normal pancreas. MRCP is a special kind of MRI exam that produces detailed images of the~     pancreas. The investigators also want to figure out how much fluid the pancreas releases in~     response to secretin. Secretin is a chemical in the body that causes the pancreas to release~     fluid that helps with digestion. Secretin is used during the MRCP (MR-PFT) to help identify~     dysfunction of the pancreas. MR elastography (MRE) will be used to measure how hard the~     pancreas is. MRE is a special kind of MRI that uses vibrations to image tissue.~   "
53254|NCT02869880|"~     Nested within the COMBINE pragmatic clinical trial, the investigators will conduct a cluster~     randomized controlled trial to determine whether, in parents (of children with Crohn's~     Disease) or patients > 18 years old being approached for trial participation, a pre-consent~     discussion enhanced with decision aids is more effective than the standard pre-consent~     discussion in transferring knowledge to parents/patients related to trial participation.~   "
53255|NCT02869867|"~     Nursing study, prospective, randomized, two-center open-label.~      Patients will be randomized into two groups during their first laying Qutenza®:~        -  Patients receiving the laying of Qutenza® without refrigerated cushion~        -  Patients receiving the laying of Qutenza® associated with a refrigerated cushion~      The objective of the study is to evaluate the effectiveness of the application of cold to the~     reduction of pain (burning) after one hour of patch installation high concentration capsaicin~     (Qutenza®) in patients localized neuropathic pain.~   "
53256|NCT02869854|"~     In a pilot study 90 physically inactive patients will be randomized to three different~     intervention groups; mindfulness training, mindfulness training and Physical Activity on~     Prescription (PAP) or only PAP Follow-up will be done at baseline, three and six months with~     questionnaires, accelerometers and analysis of traditional risk factors to evaluate whether~     mindfulness may increase physical activity and decrease physical inactivity.~   "
53257|NCT02869841|"~     Midline laparotomy is commonly used in emergency and elective cancer surgery and patients~     need effective and safe pain treatment after this type of surgery. Nowadays modern~     anticoagulant therapy may prevent use of central regional blocks in pain management.~     Therefore in the present study the efficacy and safety of rectus sheath analgesia is studied~     using different administration techniques. The primary aim is the efficacy of the rectus~     sheath analgesia measured with pain ratings and the amount rescue opioid used.~      Secondary aims were concentrations of local anesthetic, rescue opioid and satisfaction to~     analgesia method used.~   "
53258|NCT02869828|"~     Core temperature monitoring is mandatory during major surgery. The accurate techniques~     currently used are invasive, such as artery catheter and oesophagal probe. A new non-invasive~     cutaneous device, 3M SpotOn, using Zero Heath-Flux method, continuously measure core~     temperature. This prospective study compare the accuracy of Zero-Heath-Flux to oesophagal~     temperature (30 patients) and to artery catheter (20 patients) in adult patients during~     surgery.~   "
53276|NCT02869594|"~     Database of Institut Paoli-Calmettes patients diagnosed with prostate cancer~   "
53277|NCT02869581|"~     Database of Institut Paoli Calmettes diagnosed with Pancreatic neoplasms~   "
53260|NCT02869802|"~     Researchers are looking for better ways of understanding and treating pancreatic cancer. The~     purpose of this study is to see how useful it is to look for changes and characteristics in~     your genes (molecules that contain instructions for the development and functioning of the~     cells) and the genes within the tumour. These characteristics may be useful in choosing~     treatments for patients in the future. Changes (mutations) in genes have been shown to be an~     important characteristic in cancers. Looking at differences in genes in patients with~     advanced pancreatic ductal adenocarcinomas and comparing this information with response to~     their initial chemotherapy treatment may help to learn which treatments may be better for~     certain patients after initial treatment.~   "
53261|NCT02869789|"~     A study to evaluate the safety and efficacy of Nivolumab given in combination with Ipilimumab~     in patients with advanced cancers. The initial group will enroll patients with newly~     diagnosed Stage 4 or non-small cell lung cancer that has come back.~   "
53262|NCT02869776|"~     The objective of this proposal is to develop an optimal testing strategy for HCV and HIV in~     high prevalence settings, such as detoxification centers with a large proportion of young~     injection drug users. The latest venipuncture testing will be compared to rapid finger stick~     testing for HCV and HIV. Outcomes for each strategy among individuals admitted at a~     short-term drug detoxification center will be determined.~   "
53263|NCT02869763|"~     The aim of the clinical trial is to study the intra-individual variation of steroid profile~     parameters after experimental administration of different doses of ethanol in Caucasian~     women.~   "
53264|NCT02869750|"~     To evaluate possible clinical effects of adipokines , ( ghrelin, resistin and adiponectin),~     in obese and non-obese patients with polycystic ovary syndrome (PCOS).~   "
53265|NCT02869737|"~     Traumatic coagulopathy is frequent and is an independent risk factor of mortality. Its~     detection mainly relies upon classic biological test like the prothrombin time and the~     international normaliezd ratio (INR). These tests are not available at the bedside. Point of~     care (POC) device for INR measurement are now available like the Coaguchek, Roche, France.~     The aim of the present study is to test the correlation between the POC INR and the~     laboratory INR.~   "
53266|NCT02869724|"~     This study will evaluate the efficacy of an advice with a weekly divided drug delivery,~     compared to an usual monthly delivery in the prevention of voluntary drug intoxications~     repeated.~   "
53267|NCT02869711|"~     The present study focuses on the quality of care and how the health executives can bring it~     to a central place in their management. A training-action has been set-up at the Health~     Executive training institute (University Hospital Grenoble) to improve care quality. Reports~     prepared by students (tutored projects) related to operational diagnosis and action plans~     about care quality improvement are given to health executives. The objective is to evaluate~     how the health executive will use the tutored project to improve care quality and set-up~     actions.The hypothesis is that the health executive will use the tutored project to improve~     project management.~   "
53268|NCT02869698|"~     This prospective research aims to develop the use of Spectral Imaging in addition Dynamics of~     cortical electrical stimulation to identify major anatomical and functional networks in~     epileptic patients candidates for surgery and explored by stereoencephalography, to minimize~     risk of post-surgical cognitive deficits.~   "
53269|NCT02869685|"~     The detection of tissue PD-L1 immunohistochemistry in NSCLC has an important role in guiding~     for the treatment of immune detection point.Radiation therapy can enhance the effect of~     immunotherapy,but radiation dose and timing are waiting to be solved. At the same time,tissue~     detection is time-consuming and laborious, liquid biopsy can reflect the information of tumor~     tissue,PD-L1 mRNA in plasma exosomes (pExo) is expected to be simple, rapid, non-invasive~     means of detection. The project is planned to explore the consistency analysis of PD-L1~     expression level detected in tissues and pExo before and after radiotherapy.We have designed~     five kinds of radiation-division with bioequivalent doses, and detected the expression levels~     of PD-L1 in pExo after 24h, 48h of each stage of radiotherapy.PD-L1 mRNA levels in pExo~     detected at different time points,by using variance analysis of repeated measures design~     information.Probing the best timing and manner of radiotherapy division which can make PD-L1~     express more,guiding clinical practice of radiotherapy combining with immunotherapy.~   "
53270|NCT02869672|"~     This study evaluates the safety and immunogenicity of the ACYW135 Meningococcal~     Polysaccharide Vaccine in population aged 2-50 years old. Subjects will be divided into 3~     group according to their age, receiving the test vaccine and the control vaccine at the~     proportion of 1:1 randomly. Each age group has 400 subjects, 1200 in total.~   "
53271|NCT02869659|"~     This randomized controlled clinical trial will use methylomic and transcriptomic profiling to~     examine the effects of a weight loss intervention on the cholesterol metabolism gene network~     in monocytes and adipocytes and investigate the longitudinal relationship between these~     modifications and glycemic improvements.~   "
53272|NCT02869646|"~     Current treatments for Veterans with PTSD include medications and therapy where the patient~     talks about traumatic events in order to desensitize to them. While these treatments work for~     many, a large minority of Veterans do not want medications or exposure therapy. The~     investigators developed an acupuncture (ACU) treatment for PTSD in order to broaden treatment~     options. The investigators' first study showed that it helped most people. However, the~     investigators need better scientific evidence that it works by comparing ACU to a placebo,~     such as sham acupuncture (fewer needles in non-important sites) and determining if ACU~     alters abnormal physiology in PTSD. In this study 90 Veterans will be randomly assigned (like~     a coin flip) to receive either ACU or sham. The investigators expect to find that the ACU~     treated patients have more improvement in PTSD and in physiology (less startle reaction -~     assessed non-invasively using skin sensors) than the patients in the sham group. This study~     will provide information to support the use of acupuncture for PTSD at the VA, which will~     expand treatment options.~   "
53273|NCT02869633|"~     This phase II trial studies how well ibrutinib works in treating patients after a donor stem~     cell transplant for lymphoma that is not responding to treatment or has come back. Ibrutinib~     may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~   "
53274|NCT02869620|"~     Database of Institut Paoli-Calmettes patients diagnosed with thyroid cancer~   "
53275|NCT02869607|"~     Database of Institut Paoli-Calmettes patients diagnosed with breast cancer~   "
53290|NCT02869412|"~     This randomized pilot clinical trial studies how well a computer-based behavior change guide~     works in increasing physical activity in patients with prostate cancer who have received~     androgen deprivation therapy. A computer-based behavior change guide website may increase~     physical activity level for prostate cancer survivors and help doctors understand what~     outcomes related to becoming physically active are most important to patients with prostate~     cancer.~   "
53291|NCT02869399|"~     This is an open-label randomized phase II multicenter trial. An estimated 350 patients deemed~     to be in complete remission at month 3 after curative treatment are considered for this~     trial. Two arms of intervention are foreseen: the experimental arm (arm A) based on dietary~     intervention in addition to standard recommendations and a control arm (arm B) including only~     standard recommendations. The intervention strategy is based on the AICR/WCRF recommendations~     for cancer and recurrences prevention and it is focused on decreasing inflammation, glycaemia~     and insulinaemia while promoting nutrient-rich diet. The reduction in the incidence of tumor~     recurrence will be analyzed comparing EFS curves between the two arms with the non-parametric~     Kaplan-Meier method. Secondary analyses will describe the time trend in the prevalence of~     side effects and quality of life, as assessed by the EORTC QLQ-H&N35 questionnaire.~     Translational analysis (cytokine, salivary and plasmatic miRNA) will be performed. The trial~     is coordinated by Istituto Nazionale Tumori, Milan and conducted in 6 European countries.~   "
53292|NCT02869386|"~     Prehospital stroke care in specialized ambulances increases thrombolysis rates, reduces~     alarm-to-treatment times, and improves prehospital triage. Preliminary analyses suggest~     cost-effectiveness. However, scientific proof of improved functional outcome compared to~     usual care is still lacking. The objective of this trial is to show improved functional~     outcomes after deployment of the Stroke Emergency Mobile (STEMO) compared to regular care.~   "
53293|NCT02869373|"~     The aim of this study is to investigate the effects of an 8-week lumbar spinal stabilization~     exercise program on pain, trunk muscle endurance and postural stability in women with benign~     joint hypermobility syndrome~   "
53294|NCT02869360|"~     Traditional Magnetic Resonance Imaging (MRI) in Multiple Sclerosis (MS) has enabled~     clinicians to measure disease activity but there are inherent limitations.~     Clinical/radiographic dissociation can be seen in some patients and the abnormalities are not~     specific.~      This pilot study is an opportunity to determine the relationship between quantitative~     advanced MRI measures and OCT with PET measurements of microglial activation and myelin~     health.~   "
53295|NCT02869347|"~     Iodinated contrast media have been causally linked to acute kidney injury known as~     contrast-induced nephropathy (CIN), which is the consequence of CM-induced local renal~     ischemia and direct toxic effects. Conestat alfa (recombinant human C1 esterase inhibitor)~     has been shown to decrease renal ischemic damage in experimental models of renal ischemia.~      The Recombinant Human C1 Esterase Inhibitor in the Prevention of Contrast-induced Nephropathy~     in High-risk Subjects (PROTECT) Study is a randomized, placebo-controlled, double-blind~     single-center trial that will assess the effect of prophylactic administration of Conestat~     alfa on the degree of acute kidney injury subjects undergoing elective coronary angiography.~     Patient with an estimated glomerular filtration rate <=50 ml/min/1.73 m2 and at least one~     additional risk factor for CIN will be enrolled and randomly assigned to 1) Conestat alfa at~     50 U/kg given as intravenous injection immediately before and 4 hours after coronary~     angiography or 2) placebo (sodium chloride). All patients will receive standard intravenous~     hydration with isotonic saline. Surrogate markers of kidney injury will be assessed over a 48~     hours time period. Patients will be followed for cardiovascular and renal events over 12~     weeks.~      The primary outcome measure is peak change in urinary Neutrophil gelatinase-associated~     lipocalin within 48 hours after elective coronary angiography.~   "
53296|NCT02869334|"~     The purpose of this study is to determine whether transcranial direct current stimulation~     (tDCS), when combined with different forms of computer based training, improves the ability~     to discriminate small differences between sounds in people diagnosed with schizophrenia or~     schizoaffective disorder.~   "
53297|NCT02869321|"~     Patients with Head & Neck Squamous Cell Carcinoma often need a gastrostomy. It can be~     performed with a radiological approach. This procedure is usually not performed under general~     anesthesia, but local anesthesia is not sufficient to counteract pain due to gastric~     insufflation and incision of the abdominal wall. Standard analgesic treatments are usually~     not well-fitted due to onset of action or route of administration. An alternative solution~     could be fentanyl nasal spray, a treatment with a fast onset of action and with easy use~     allowing repetition if needed, during the procedure.~      The purpose of this study is to compare analgesic efficacy of nasal instillation of PECFENT®~     to usually administered morphinic analgesic treatment with fast onset of action (ORAMORPH®),~     in radiologic percutaneous gastrostomy tube placement:~        -  during the procedure~        -  following the procedure (measured by Visual Analog Scale (VAS) for Pain at 15 min, 30~          min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours and 12 hours after procedure).~      Secondary purposes are to compare easiness of 2 treatments and their adverse effects.~   "
53298|NCT02869308|"~     The purpose is to determine whether measurements of left ventricular ejection fraction (LVEF)~     obtained with angiographies recorded by conventional Anger camera or D-SPECT camera are~     equivalent.~      Secondary purposes are:~        -  To evaluate the influence of cardiac activity recorded by D-SPECT camera on equivalences~          defined in primary purpose~        -  To evaluate the influence of the indication for the examination with a distinct analysis~          of a group having the examination for a known or suspected cardiomyopathy (LVEF often~          abnormally low) and a group having the examination for a chemotherapy supervision with~          heart initially considered healthy (LVEF often normal).~   "
53299|NCT02869295|"~     This is a first in human, open-label, sequential dose escalation and expansion Phase 1 study~     of NKTR-214 in adult patients with locally advanced or metastatic solid tumors.~   "
53300|NCT02869282|"~     Multicentric, observational, prospective, non-interventional study with occasional biological~     sample collection (serum bank, urine bank and tumor bank)~   "
53301|NCT02869269|"~     Previous studies have shown that colorectal cancer patients' prognosis and overall survival~     was related with immune cell expression in patients' tissue. However, the circulating immune~     cell activity changes in patients' blood has few studies. The purpose of this study is to~     analyze the variation of circulating immune cell activity in colorectal patients' blood which~     is classed as clinical staging.~   "
53304|NCT02869230|"~     Here were present a controlled clinical trial comparing wire-guided lesion localization~     (WGLL)and radioguided occult lesion localization (ROLL) in patients treated for nonpalpable~     breast lesions at the Instituto Nacional de Cancerología (National Cancer Institute)in~     Bogotá,Colombia.~   "
53305|NCT02869217|"~     The target populations for this phase I study with TBI-1301 are patients with advanced solid~     tumors. Patients' tumors will be required to express NY-ESO-1, which include but is not~     limited to ovarian cancer, synovial sarcoma, esophageal cancer and malignant melanoma.~     Patients must be positive for HLA-A*02:01 or HLA-A*02:06 and the patient's tumor tissue must~     be positive for NY-ESO-1 antigen expression. The study will take the subject's T cells, which~     are a natural type of immune cell in the blood, and send them to a laboratory to be modified.~     The changed T cells used in this study will be the subject's own T cells that have been~     genetically changed with the aim of attacking and destroying cancer cells.~      The manufacturing of T cells takes about 1 month to complete. The T cells will be given back~     to the subject through an intravenous infusion. The purpose of this study is to test the~     safety of genetically changed T cells and find out what effects, if any, they have in~     subjects with advanced solid tumors.~      The purpose of this study is to evaluate the safety profile of TBI-1301, to determine the~     recommended phase 2 (RP2D) dose of TBI-1301 when administered following cyclophosphamide~     pre-treatment and to evaluate evidence of efficacy of TBI-1301 using RECIST v1.1.~   "
53306|NCT02869204|"~     The purpose of this project is to investigate whether a combination of a local injection of~     platelet rich plasma (PRP) combined with a daily supplement of vitamin C, zinc, L-arginine,~     as well as high protein diet (1.5 g of protein per kilo body weight per day) can promote~     tissue healing in patients undergoing open upper-abdominal surgery.~      Primary endpoint is cases of wound infection and secondary endpoints are time of tissue~     regeneration (days), judged by traditional clinical observation and experimentally assessed~     by ultrasound.~      The experiment is performed as a parallel two-armed, randomized, controlled trial.~      A total of 40 subjects will be included in the trial i order to ensure the power of the~     study, despite a drop off of up to 25%.~   "
53307|NCT02869191|"~     The purpose of this study is to assess the blood cultures' profitability in intensive care~     unit and create a validated prediction rule for extractioning in critical patients.~   "
53308|NCT02869178|"~     Introduction : Patients with heart failure (HF ) with systolic dysfunction of moderate to~     severe exhibit significant reduction in the ability to exercise compared to those with mild~     dysfunction , and have worse prognosis. However, some clinical markers of severity and~     diagnosis widely used in this population such as ejection fraction (EF) , are not always able~     to translate the actual degree of cardiac damage as well as their relationship with the~     cardiorespiratory fitness of these individuals and prognosis .~      Objective: To evaluate the ability of the global longitudinal strain ( GLS ) in predicting~     exercise tolerance in heart failure patients with moderate and significant systolic~     dysfunction.~   "
53309|NCT02869165|"~     A randomized controlled trial looking at the effects of vaginal estrogen and a nonhormonal~     alternative on the vaginal and urinary microbiome in women with genitourinary syndrome of~     menopause.~   "
53310|NCT02869152|"~     The purpose of this study is to develop a technique that allows physicians to identify the~     first lymph nodes draining from a rectal tumor (the sentinel lymph nodes). Currently, there~     is no technique used to find these lymph nodes in the rectum during surgery and therefore~     many patients with rectal cancer need to undergo a total rectal resection. Dyes, tracers,~     imaging and a gamma probe will be used in this study during a standard minimally invasive~     transanal endoscopic surgery (TES) to try to locate these lymph nodes. If surgeons are able~     to locate these lymph nodes they will be removed during surgery. If the technique is~     successfully developed as a result of this research, it could help patients in the future~     with early stage rectal cancer by allowing doctors to see if their cancer has spread to the~     lymph nodes of the rectum without having to undergo a total rectal resection. These patients~     would then be able to undergo a TES combined with a lymph node dissection to gain more~     knowledge about the stage of their disease. This knowledge would then be used to determine if~     and what further treatment is necessary for the patient's rectal cancer.~   "
53311|NCT02869139|"~     Package of mentholated measures for the relief of thirst in the anesthesia recovery room:~     Randomized clinical trial~   "
53312|NCT02869126|"~     The purpose is to demonstrate the concordance of diagnostic information obtained with:~        1. a conventional examination with 2 distinct recordings on D.SPECT camera after~          99mTc-sestamibi injections, the first post-stress and the second at rest, 2 to 3 hours~          later,~           and~        2. a double isotope examination with a supplementary recording after injection of a little~          activity of thallium-201 at rest after the first recording and before the second~          injection of 99mTc-sestamibi for conventional recording at rest,~      in patients showing abnormalities of myocardial perfusion in stress myocardial~     tomoscintigraphy.~   "
53313|NCT02869113|"~     The objective of this study was to compare the human eye stinging potential of experimental~     formulas and an industry standard shampoo mixture. The study was conducted under the~     supervision of a Board Certified Ophthalmologist.~   "
53321|NCT02869009|"~     The risk of early recurrence or progression of acute ischemic stroke is very high, even in~     patients treated with aspirin. The Chance study show that clopidogrel plus aspirin treatment~     reduced the risk of recurrent stroke in patients with transient ischemic attack (TIA) or~     minor ischemic stroke (NIHSS ≤ 3) within 24 hour onset and was not associated with increased~     hemorrhage events, compared with aspirin monotherapy. However, it is not known whether the~     dual antiplatelet treatment could reduce the risk of early recurrence or progression in~     patients with acute mild to moderate ischemic stroke (4 ≤ NIHSS ≤ 10). The investigators~     hypothesise that clopidogrel-aspirin treatment will be superior to aspirin monotherapy in~     this group of patients.~   "
53322|NCT02868996|"~     This is a Phase 1B study to assess the safety, tolerability and pharmacokinetics of DM199 in~     healthy volunteers. The study will be consist of two parts: Part A will focus on intravenous~     dosing and Part B will directly compare intravenous dosing with subcutaneous dosing.~   "
53414|NCT02867800|"~     To assess the tolerability of the costimulation blocking agent abatacept (CTLA4-Ig) when~     added to the standard graft versus host disease (GVHD) prophylaxis regimen of a calcineurin~     inhibitor and methotrexate in patients receiving early alemtuzumab followed by fludarabine,~     thiotepa, melphalan, and alemtuzumab for conditioning.~   "
53314|NCT02869100|"~     The purpose is to compare detection of axial inflammatory lesions in patients affected by~     spondyloarthritis (SpA) with sodium fluoride positron emission tomography (PET) and magnetic~     resonance imaging (MRI), the reference technique.~      It would be interesting to show the superiority of sodium fluoride PET on MRI for diagnosis~     of inflammatory lesions. It could be used for diagnostic care but also therapeutic care of~     patients with early forms of spondyloarthritis.~      Secondary purposes are:~        -  To evaluate performances of sodium fluoride PET in detection of SpA peripheral damage~          (except spine and sacroiliac joints)~        -  To evaluate bone inflammation (axial and peripheral) with sodium fluoride PET and~          compare these data to clinic-biologic parameters used in clinical practice (BASDAI,~          BASFI, BASMI, sedimentation rate, C-reactive protein (CRP)) and to structural evaluation~          (sacroiliac New York, mSASSS and BASRI scoring methods)~        -  To study correlation of axial and peripheral bone inflammation (spine and sacroiliac~          joints) evaluated with sodium fluoride PET with biologic markers of inflammation and~          bone remodeling (MMP-3; DKK-1, IL-6, IL-17, TNF-α).~      Known biologic markers of inflammation in SpA are correlated to activity obtained with MRI.~     It is interesting to compare to activity obtained with PET. Moreover, it has been recently~     showed the disassociation of inflammation and structural progression (anti-TNF treatments do~     not prevent structural progression) that is associated to markers of bone remodeling whose~     activity is influenced by an activation/inhibition system of biologic markers of~     inflammation.~   "
53315|NCT02869087|"~     The aim of this study is to prospectively collect information to evaluate the safety and~     performance of the Akesys Prava Sirolimus Eluting Bioresorbable Peripheral scaffold system~     for the treatment of symptomatic primary atherosclerotic stenoses and occlusions of the~     superficial femoral artery (SFA).~   "
53316|NCT02869074|"~     The present Project is a third phase of the previous PCM-EVW-ES Project (Batlle et al. Thromb~     & Haemost 2015) with the aim of its extension, further analysis with an innovation~     development in the field of von Willebrand disease (VWD) based in the newer recently~     available methodologies. The aim of this project is to help the physician in a more uniform~     characterization and therapy of VWD in clinical practice, at an international level. A~     reduction of the expenses in the diagnosis process by using the new methodologies is pursued.~   "
53317|NCT02869061|"~     Autologous adipose-derived regenerative cells (ADRC) will be extracted from lipoaspirate by~     enzymatic digestion from a portion of the fat harvested from the patient's front abdominal~     wall. Transurethral bladder neck resection followed by the injection of ADRCs suspension will~     be performed. This is a single arm study with no control. All patients receive cell therapy.~   "
53318|NCT02869048|"~     Amyotrophic Lateral Sclerosis (ALS) is an aggressive, deadly disease. ALS leads to~     destruction of the neural pathways which control the conscious movements of the muscles. This~     destruction leads to muscular dystrophy with increasing difficulties in moving, breathing,~     swallowing, and speaking. In the last phase of an ALS patient's life it is necessary with~     respiratory therapy in order to breathe. In average an ALS patient lives 3 years from the~     time he or she gets the diagnose.~      The cause of the disease is still unknown and there is currently no treatment which can stop~     the progression of the disease. Former clinical studies have indicated that the innate immune~     system and in particular the complement system plays a significant role in the progression of~     ALS. The complement system, which is activated in cascades, is part of the innate system but~     participates in the innate as well as the acquired immune system. Former clinical trials have~     been characterized by limited knowledge about both the complement system as well as to how it~     is measured.~      Today it is possible to measure directly on the different components of the complement system~     and to understand its contribution to the overall immune response. It is also possible today~     to detect defects of the complement system. All these progressions are the foundation for~     this project which is carried out in close cooperation with one of the world's leading~     researchers in the complement system, professor Peter Garred from Rigshospitalet.~      The aim is to make a national research project about ALS in order to investigate the role of~     the innate immune system, and especially the complement system, in patients with ALS.~      In the long term the hope is, that this will lead the way to a targeted and effective medical~     treatment to the people affected by this grave disease.~   "
53319|NCT02869035|"~     Major Depressive Disorder (MDD) is one of the most severe and frequently occurring brain~     disorders worldwide. It has been linked to serotonergic dysfunction, sexual dysfunction,~     vulnerability to stress and neuro-inflammation. However, at the same time the etiological~     understanding is limited. Most antidepressants act on the serotonin (5- HT) system, yet~     between 30-50 % of patients with MDD does not respond successfully to 5-HT acting drugs.~     Recent experimental models from our group suggest that cerebral 5-HT levels in vivo can be~     indexed through molecular brain imaging of the 5-HT 4 receptor (5-HT4R) with a novel Positron~     Emission Tomography (PET) ligand (11C-SB207145). Also, our human studies have confirmed that~     cerebral synaptic 5-HT is inversely related to 5-HT4R binding and this technique thus can be~     used to investigate the role of 5-HT tone in the brain in MDD with differential responses to~     standard antidepressant treatment. By using multimodal neuroimaging technology, we aim to~     determine the status of the 5-HT system prior to and after either successful or failed~     neuropharmacological intervention in a non-randomized longitudinal open clinical trial. 100~     untreated patients with moderate to severe MDD will be included. Data collection from various~     neurobiological domains (i.e, 5-HT4R PET imaging, Magnetic Resonance Imaging (MRI),~     functional MRI (fMRI), electroencephalogram (EEG), psychometrics, neuropsychological tests,~     and peripheral biomarkers) will be conducted before, during and after 12 weeks of~     antidepressant treatment. The objective is to identify predictors of pharmacological~     antidepressant treatment response in depressed individuals before and after 8 weeks of~     antidepressant treatment.~   "
53320|NCT02869022|"~     The objective of this investigation is to demonstrate non-inferiority in outcome of~     Custodiol-N against Custodiol in heart transplantation.~   "
53408|NCT02867878|"~     The investigators will randomize patients admitted to hospital with Takotsubo diagnosis to~     systematic high-dose adenosine infusion for 3 minutes (in addition to standard of care) vs.~     standard of care. The primary aim of the study is to demonstrate that adenosine infusion is~     associated with a larger and more rapid recovery of left ventricle function.~   "
60397|NCT02776306|"~     The purpose of this study is to evaluate the effects of mirror box therapy on upper~     extremity, motor recovery and motor functioning in patients that have suffered a stroke.~   "
53323|NCT02868983|"~     Behavioral problems are part of many of the chronic diseases that cause the majority of~     illness, disability and death. Tobacco, diet, physical inactivity, alcohol, drug abuse,~     failure to take treatment, sleep problems, anxiety, depression, and stress are major issues,~     especially when chronic medical problems such as heart disease, lung disease, diabetes, or~     kidney disease are also present. These behavioral problems can often be helped, but the~     current health care system doesn't do a good job of getting the right care to these patients.~      Behavioral health includes mental health care, substance abuse care, health behavior change,~     and attention to family and other psychological and social factors. Many people with~     behavioral health needs present to primary care and may be referred to mental health or~     substance abuse specialists, but this method is often unacceptable to patients. Two newer~     ways have been proposed for helping these patients. In co-location, a behavioral health~     clinician (such as a Psychologist or Social Worker) is located in or near the primary~     practice to increase the chance that the patient will make it to treatment. In Integrated~     Behavioral Health (IBH), a Behavioral Health Clinician is specially trained to work closely~     with the medical provider as a full member of the primary treatment team.~      The research question is: Does increased integration of evidence-supported behavioral health~     and primary care services, compared to simple co-location of providers, improve outcomes? The~     key decision affected by the research is at the practice level: whether and how to use~     behavioral health services.~      The investigators plan to do a randomized, parallel group clustered study of 3,000 subjects~     in 40 practices with co-located behavioral health services. Practice randomized to the active~     intervention will convert to IBH using a practice improvement method that has helped in other~     settings. The investigators will measure the health status of patients in each practice~     before and after they start using IBH. The investigators will compare the change in those~     outcomes to health status changes of patients in practices who have not yet started using~     IBH.~      The investigators plan to study adults who each have both medical and behavioral problems,~     and get their care in Family Medicine clinics, General Internal Medicine practices, and~     Community Health Centers.~   "
53324|NCT02868970|"~     This project proposes to implement and compare new community pharmacy-based strategies for~     improving vaccine coverage.~   "
53325|NCT02868957|"~     The objectives of this study were to compare the precision of two digital intraoral scanners~     from a series of repeat scan images, and to investigate the effect of the learning curve on~     changes in trueness when scanning the full arch of the oral cavity in actual patients.~   "
53326|NCT02868944|"~     The addition of morphine to a local anesthetic when performing an epidural analgesia during~     labor analgesia has improved the efficiency and the action duration of analgesia. One~     limitation of this technique is the time of installation of the analgesic effect (about 30~     minutes) when using the only epidural. Therefore, the technique of sequential combined spinal~     epidural was introduced. This is to shorten the installation time by direct injection into~     the cerebrospinal fluid. This allows a good efficiency in less than 10 minutes. It has been~     shown that low doses of sufentanil (strong opioid) in spinal anesthesia could potentiate the~     effect of the local anesthetic.~   "
53327|NCT02868931|"~     This study is a randomized, controlled, prospective trial with a 6-month follow-up. A newly~     developed treatment and education programme for diabetic patients with an insulin pump~     therapy (INPUT) will be tested compared to a waiting group. Primary outcome variable is the~     difference in glycemic control between baseline and the 6-month follow-up. Secondary outcome~     variables are: severe hypoglycaemia, diabetes-related distress, depressive symptoms,~     health-related quality of life, diabetes empowerment, self-care behavior, hypoglycemia~     awareness, and attitudes towards insulin pump therapy.~   "
53328|NCT02868918|"~     The aim of this study is to compare the effect of new bioactive dentine substitute~     (Biodentine) versus glass ionomer cement in very deep carious lesions clinically and~     radiographically using digital radiography in the terms of postoperative pain and~     biocompatibility to the pulp.~   "
53329|NCT02868905|"~     The purpose of this study is to compare average methylation of epigenetic markers on genomic~     DNA and some genes (APP, BACE, LRP, SorL1) involved in cerebral amyloid homeostasis:~        -  Of obese young adults and healthy young adults~        -  Of obese young adults and individuals affected by Alzheimer's disease (AD) having been~          obese at young adult age (<50 years old) or individuals affected by Alzheimer's disease~          (AD) having never been obese.~      The secondary purpose is to determine if there is an association between the frequency of~     these epigenetic markers and elements associated to the metabolic syndrome (lipidic and~     glycemic analysis, leptinemia, inflammation markers) and clinical ones (visceral fat mass,~     body mass index) in young adults.~   "
53330|NCT02868892|"~     Patients with advanced or recurrent adenocarcinoma or adenosquamous cell carcinoma of the~     cervix will receive Pemetrexed.~   "
53331|NCT02868879|"~     The different subtypes of Schizophrenia might have a disordered connectivity as their final~     common pathways.~      The investigators will use multimodal structural MRI to assess anatomical connectivity on the~     one side and its functional consequence on functional connectivity on the other side to~     assess two phenotypes of psychosis : periodic catatonia and cataphasia in comparison with~     control subjects.~      The coherence between structural and functional anomalies will be especially studied.~   "
53332|NCT02868866|"~     The USC PRC's applied research project will study the dissemination and implementation of an~     evidence-based program shown previously to significantly increase physical activity and fruit~     and vegetable intake in churches in South Carolina (Faith, Activity, and Nutrition; FAN).~     Guided by two theoretical frameworks, the specific aims of the applied research project are~     to: 1) examine the adoption and reach of FAN in churches and organizational factors~     associated with adoption; 2) characterize implementation fidelity and multilevel factors~     associated with implementation; 3) describe organizational maintenance of FAN and factors~     associated with maintenance; and 4) study the effectiveness of FAN. In Phase 1, churches in a~     rural county with a high proportion of African American residents will be randomized to~     receive training in FAN from a community health advisor (n=40) or to be part of a delayed~     intervention control group (n=20). In Phase 2, a quasi-experimental study wil be done with a~     large religious denomination in SC (churches are not randomized).~   "
53333|NCT02868853|"~     The purpose of the study is to test the effectiveness of two different methods of mobile~     dietary self-monitoring for weight loss. Both of these interventions will provide weight loss~     information through twice weekly audio podcasts. In addition to the podcasts, participants~     will be asked to track their diet using an assigned mobile applications (for their~     smartphone), which will be randomly assigned.~   "
53334|NCT02868840|"~     Tai Chi, an ancient Chinese martial art, is a low intense aerobic exercise characterized by~     continuous movements that embrace the mind, body, and spirit. Tai Chi addresses the~     integration and balance of mind and body using the fundamental principles of slow, smooth,~     and continuous movement control, and the transfer of body weight while maintaining an upright~     and relaxed posture. The present randomized clinical trial project aims to apply the~     suggested principles as the typical features of Tai Chi applied stroke rehabilitation, and to~     evaluate the effects on physical (balance), psychological, and cognitive function.~   "
53335|NCT02868827|"~     The purpose of the research study is to determine whether a single high dose of vitamin D is~     helpful in reducing critical illness related complications in intensive care patients who are~     having sever vitamin D deficiency.~      Vitamin D deficiency is quite common in critically ill patients ranging from 81.5% to 99%. A~     number of scientific studies have documented a strong correlation between low levels of vit.D~     and increased rate of adverse outcomes including infection, acute kidney injury and mortality~     in ICU patients. A recent randomized controlled trial (RCT) has demonstrated 50% reduction in~     hospital mortality in severe vit.D deficient patients following a single high dose of~     cholecalciferol (Vitamin D3). However the role of Vit.D supplementation to boost up host~     immune system and eventually reduction of mortality has yet to be determined by large~     randomized controlled trails in humans. Hence we aim to run a randomized controlled trial~     (RCT) in order to study the role of Vitamin D in critically ill patients.~   "
53336|NCT02868814|"~     The purpose of this study is to evaluate the Efficacy and safety of pregabalin sustained~     release tablets versus placebo for fibromyalgia~   "
53337|NCT02868801|"~     The purpose of this study is to evaluate the Efficacy and safety of pregabalin sustained~     release tablet versus placebo for postherpetic neuralgia.~   "
53338|NCT02868788|"~     This study will help elucidate the mechanism underlying the cardioprotective and~     anti-diabetes effect of dietary fiber by exploring a comprehensive set of inflammatory and~     oxidative stress markers, based on a contemporary understanding of this process. In addition,~     there have been very few studies that explored the immediate change in oxidative stress and~     incretin secretion after fiber intake. In this study, the investigators will be able assess~     the short term metabolic impact of dietary fiber at great details. The result will contribute~     to dietary recommendation or designing of fiber supplementation for prevention/treatment of~     diabetes, obesity and cardiovascular disease.~   "
53339|NCT02868775|"~     This is a prospective pilot study, with a recruitment goal of 60 patients. Patients who are~     female, above the age of 18, and with a diagnosis of IC/BPS based on clinical criteria and~     O'Leary Sant ICPI and ICSI scores undergoing cystoscopy, hydrodistention and bladder biopsy~     will be included. The bladder biopsies will be evaluated for TLR4 expression, and sent for~     histological assessment of mast cell count. Additionally, data will be collected at baseline,~     day of surgery, day 7, day 14 and day 28. Data will include validated questionnaires, lower~     urinary tract symptoms, and recorded pain medication use.~   "
53340|NCT02868762|"~     This study investigates in patients whose primary complaint is either neck pain and/or a~     voice disorder , if there are any correlations between subjective neck and voice symptoms~     according to Neck Disability Index (NDI) and Voice Handicap Index (VHI). NDI and VHI~     questionnaire results for voice disordered patients will be retrieved from the data base of~     the Department of Phoniatrics and Speech Pathology, University Hospital Zurich. Neck pain~     patient questionnaire data will be retrieved from an ongoing study. The agreement between~     subjective neck handicap (NDI) and voice handicap (VHI) will be statistically analysed.~   "
53341|NCT02868749|"~     This study is a single-blind intra-individual comparative study to evaluate the short and~     medium term tissue response after the injection of 2 brands of hyaluronic acid gels (HA),~     designed for deep injection, that have been used for several years on a worldwide scale.~   "
53342|NCT02868736|"~     -  To demonstrate the tests' performance when compared to the detection of PJI using the~          Musculoskeletal Infection Society (MSIS) criteria-based definition of PJI for diagnosing~          PJI.1 This criteria-based definition of PJI places emphasis on culture techniques that~          identify pathogens, but also provides for minor criteria that can be used to diagnose~          PJI;~        -  To calculate the tests' clinical sensitivity, clinical specificity, positive predictive~          value (PPV), and negative predictive value (NPV).~   "
53343|NCT02868723|"~     This will be a prospective randomized 2 year study of patients admitted to the Hamad General~     Hospital (HGH) and the Stroke Prevention Clinic with a diagnosis of ischemic stroke (IS) and~     Transit ischemic attacks (TIAs). After signing of the informed consent forms and initial~     evaluation and investigations, all patients enrolled in the two arms ( study arm and control~     arm) of the study will be followed for one year (monthly visits for the first three months~     followed by visits three months until completion of study: total of 6 follow up visits) and~     the pre-specified investigations repeated at the one year follow up. In one arm (the control~     group), the patients will be offered best risk factor management strategies as currently~     being practiced by stroke specialists at HGH in Qatar. And in the second ( the subject group)~     arm, with assistance of a nurse-practitioner and pharmacist, the investigators will make~     aggressive attempts to meet to target defined risk factors and have the evaluations and~     investigations completed as in the initial year cohort. All patients will have risk factor~     stratification according the Framingham Risk Score (FRS) and the change in score measured~     over time.The primary objective will be to determine if an approach that utilizes a~     comprehensive strategy results in a significantly outcome. A clinically 'meaningful'~     difference in the blood pressure (BP) and lipid control of 10% between the aggressively~     managed versus patients treated with the standard of care will require minimum of 200~     patients in each group (alpha error set at 0.05 and beta error at 0.20, power 80%) to be~     recruited over 1 year and followed for one year (total study duration 2 years).~      All patients will have screening magnetic resonance imaging (MRI) (including gradient echo~     (GRE) sequence), carotid 3D Doppler measurement of plaque volume, and PAD assessments,~     C-reactive protein (CRP) and evaluation for protein urea at baseline. These studies will be~     repeated in 1 year at the time of exit from the study. The co-primary objective would be to~     monitor progression (or regression) of plaque build-up on 3D Doppler imaging of the carotid~     arteries between the two cohorts. The investigators hypothesize that aggressive management of~     vascular risk factors to recommended target levels will lead to better vascular health.~     Compared to current practice, comprehensive and coordinated approach at preventive measures~     will lead to more patients with better control of blood pressure and lipid levels. Improved~     risk factor management will result in slowing of atherosclerosis and its downstream effects~     which will be measurable on sophisticated blood and imaging testing. Clinically this will~     translate into fewer hospital re-admissions.~   "
53344|NCT02868710|"~     The purpose of this study is to: 1) determine the cohort specific technical error to use in~     the categorization of response rate; 2) determine if an individualized intensity prescription~     is superior to a standard approach in regards to VO2max and cardiometabolic risk factor~     responsiveness; 3) Investigate the time course changes throughout 12 weeks of CRF training~     between an individualized and standardized exercise prescription; and 4) determine if~     non-responders can become responders if the exercise intensity prescription is modified.~      It is hypothesized that:~        1. The individualized method will elicit a greater responsiveness for all measurements when~          compared to the standardized method.~        2. There will be a greater amount of non-responders in the standardized group (based on~          changes in VO2max).~        3. When participants in the standardized group are considered non-responders and change~          their exercise prescription to the individualized group, they will become a responder~          (based on changes in VO2max)~   "
53741|NCT02863523|"~     The study will implement and evaluate, using a pragmatic comparative effectiveness trial, a~     unique collaborative, stepped-care intervention for patients with uncontrolled Type 2~     diabetes and co-morbid distress and/or depression.~   "
53345|NCT02868697|"~     Goal of the study:~      A- To find out the best protocol for catheter lock solution to decrease the prevalence of~     catheter thrombosis~        1. - The time to first episode of catheter thrombosis lead to catheter change.~        2. - Number of acute episode of thrombosis that interrupt dialysis~        3. - Median Survival life of the catheter in both groups after adjusting it to the outcome.~      B- Specific Objective: To evaluate the cost effectiveness by measure~        1. Amount of r-TPA used in each group to treatment acute catheter thrombosis~        2. Number of catheter exchange in both group~        3. Hospitalization days related to catheter malfunctioning or CRI in each group~        4. Type and days of antibiotics~        5. Cost of the treatment in each group~           c- Secondary Objective:~           To correlate the result of two catheters lock solution protocols with the published data~          using r-TPA instead of heparin once week as compared with heparin 3 times per week as a~          locking solution.~   "
53346|NCT02868684|"~     This longitudinal cohort study aims to detect the topographical nature of the white matter~     microstructure and resting state functional connectivity patterns across the whole brain in~     the evolution of pathology as a function of time following mild TBI. All consecutively~     patients with the non-contrast head CT because of acute head trauma from the local emergency~     department (ED) formed the initial population of this study. Age, sex, education-level~     matched healthy controls will also be enrolled. The initial scan will performed within 7 days~     post-injury. Clinical assessment was performed within 24 hours of MR imaging and included a~     broad neuropsychological and symptom assessments. Follow-up examination will conduct at 1~     month, 3 month, 6-12 months.~   "
53347|NCT02868671|"~     The overall goal of this study is to examine if acupuncture intervention can reduce the onset~     of post-traumatic stress disorder (PTSD), and affective and cognitive complaints among mild~     traumatic brain injury (TBI). This study also hypothesized that compared to those in the sham~     acupuncture and waiting list control groups, patients in the real acupuncture group will have~     fewer symptoms of depressive symptoms, sleep problems and post-concussion symptoms.~   "
53348|NCT02868658|"~     Although clinical presentation of influenza is often symptomatic, asymptomatic cases also~     occur. The knowledge of the incidence of asymptomatic influenza among healthcare workers is~     very important because of the risk of cross-transmission to hospitalized patients. The~     principal objective of the study is to estimate the incidence of symptomatic and asymptomatic~     influenza among healthcare workers in short-stay wards. The results of this study will lead~     to a better understanding of the burden of asymptomatic influenza among healthcare workers~     and might be used as an argument to increase influenza vaccine coverage among healthcare~     workers.~   "
53349|NCT02868645|"~     Fibrous dysplasia is a rare bone disease which can cause pain and fractures. It has been~     shown that periostin is over expressed in fibrous component in patients bones ; but periostin~     has never been measured out in serum of patients, although it is easy to assess. This study~     aims to show whether serum periostin is elevated in serum of patients with fibrous dysplasia,~     and if it is more elevated in patients with severe forms of the disease.~   "
53350|NCT02868632|"~     This is an open-label, three-cohort, phase Ib study to determine the safety, recommended~     phase 2 dose (RP2D), and efficacy of Stereotactic Body Radiation Therapy (SBRT) in~     combination with either (A) MEDI4736 alone, (B) tremelimumab alone, or (C) the combination of~     MEDI4736 and tremelimumab for patients with unresectable locally advanced adenocarcinoma of~     pancreas.~   "
53351|NCT02868619|"~     Obesity, defined as BMI> 30kg / m2, is a major public health problem, with devastating~     medical and psychological consequences. 30% of obese suffer from BED type of eating~     disorders. The optimal treatment of obesity remains bariatric surgery, failed in 20% of~     cases. Many arguments are in favor of the involvement of the reward circuitry, with the~     central role of NAc in the pathophysiology of BED and obesity. The recent application and~     effectiveness of DBS (Deep Brain Stimulation) in refractory psychiatric disorders suggest~     that DBS may be of interest in treating obesity and BED with potential target for the NAc.~     This project propose to study fMRI activation of the reward system in response to food~     stimuli to better direct the DBS targets. This is a pilot study to define indication criteria~     based on fMRI to obese BED patients are potential candidates for treatment with DBS.~   "
53352|NCT02868606|"~     Many hospitals have begun giving insulin to nearly all patients with diabetes while they are~     in the hospital even if a patient does not use insulin at home. Controlling blood sugar with~     insulin when a patient is hospitalized is believed to reduce the risk of complications and~     death, but research has not demonstrated these benefits except in patients who are critically~     ill. The purpose of this study, therefore, is to evaluate whether such insulin therapy~     actually does reduce in-hospital complications, deaths, need for intensive care, or length of~     stay in the hospital.~   "
53353|NCT02868593|"~     The primary purpose of this study is to assess the contribution of a non-invasive sampling~     (pharyngeal swab) in the diagnosis of community based meningitis or meningo-encephalitis.~   "
53354|NCT02868580|"~     This is a phase 2a open label, multicentre design study to investigate the safety of Triumeq~     in patients with ALS at 24 weeks post treatment. In this phase 2a study the investigators aim~     to determine whether a combination of anti-retroviral therapy, Triumeq (dolutegravir 50mg,~     abacavir 600mg, lamivudine 300mg) is tolerated and safe in patients with ALS. As secondary~     outcomes, ALSFRS-R, ALSQOL, physical examination, neurophysical parameters and respiratory~     and muscle function will be evaluated. Blood and urine samples will be stored for possible~     future analysis for viral activity. Subjects will be screened for the study after signing an~     approved Informed consent document.~   "
53355|NCT02868567|"~     This study will comprise an 18-week open label safety and tolerability trial. In this study,~     a total of 35 subjects with primary lateral sclerosis PLS or upper motor neuron predominate~     ALS will be enrolled. At the initial screening evaluation, a baseline T25FW will be obtained.~     This baseline test will be repeated at weeks 2, 4, 6, 10, 14 18. The validity of this measure~     was shown in MS studies when compared to the MSWS-12 (12 item walking scale) and CGI~     (clinical global impression) scales (35-37). A consistent responder will be defined as~     improvement in 3 of 4 Timed 25Foot Wwalk while on medication, compared with the baseline~     results while off medication.~   "
53521|NCT02866409|"~     This study has been designed to assess the efficacy of dexmedetomidine as an adjuvant to~     local anaesthetic agent bupivacaine in scalp nerve block and scalp infiltration to control~     post craniotomy pain.A third group where patients were administered bupivacaine only~     infiltration has also been created.~   "
53356|NCT02868554|"~     Purpose:~      The objective of this study is to investigate the effects of accelerated Invisalign and~     vibration therapy on rate of orthodontic tooth movement, activation of inflammation~     biomarkers as well as pain levels experienced by orthodontic patients during the initial 12~     weeks of alignment.~      Participants:~      Up to 30 orthodontic patients of the University of North Carolina Orthodontic Residency~     Program will be recruited for this study. Patients older than 18 years old will be otherwise~     healthy subjects previously diagnosed with malocclusion.~      Procedures (methods):~      Each patient will be randomly allocated into either a control group or one of two~     intervention groups. Patients within the control group will receive standard Invisalign~     therapy without vibration. Patients within the intervention groups will receive accelerated~     Invisalign therapy with or without vibration. Patients receiving vibration therapy will~     utilize an AcceleDent Aura device which provides a light vibration at .25 Newtons (N) and 30~     Hertz (Hz) frequency for twenty minutes daily. Three dimensional images of each subject's~     dentition will be recorded five times at 0 days, 4 days, 2 weeks, 6 weeks, and 12 weeks~     progress visits.~   "
53357|NCT02868541|"~     The objective of this project is to study the prevalence of viruses and bacteria responsible~     for transmissible acute respiratory infections in the respiratory tract of pilgrims returning~     from the trip. The patients included, will be the consultant pilgrims to the traveler health~     center, and before leaving for Hajj. Based on the results obtained in previous studies, it is~     estimated that 200 pilgrims will be included each year, 600 in total (inclusion period of 3~     years). Respiratory secretions are then collected by nasal swab and throat (swab) prior to~     departure for the hajj. In return, patients will be reconvened systematic consultation to~     record medical events potentially encountered during the trip, and it will again be performed~     the same nasal swabs and throat. It will then be performed on these samples' return from hajj~     molecular detection (PCR and RT-PCR) of 35 viruses and bacteria respiratory tropism:~     influenza (3), RSV (2), metapneumovirus (1), Coronavirus (4), Parainfluenzavirus (4),~     enteroviruses (4), rhinovirus (1), adenovirus (6) bocavirus, polyomavirus (2), pneumococcus,~     Bordetella pertussis, Mycoplasma pneumoniae, Chlamydophila pneumoniae, Haemophilus~     influenzae, Neisseria meningitidis and Coxiella burnetii. Samples return of hajj positive~     should be cultured for the isolation of the strain. For patients positive return, it will be~     done further research of these 35 viruses and bacteria on samples start of hajj, the same~     method described above. In addition to this systematic consultation, and if symptoms return,~     the pilgrims will be seen in consultation for a diagnosis evaluation and therapeutic~     management.~      This study will shed light on the acquisition of microorganisms respiratory tropism during~     the stay and on the potential risks associated with the circulation of these pathogens after~     the trip.~   "
53358|NCT02868528|"~     With the development of society, more and more aged pregnant women because of various~     reasons, their abnormality rate of egg chromosome was higher than that of young women, then~     the abnormality rate of embryo chromosome is higher too, so the pregnancy rate in aged women~     is lower, abortion rate is higher. In order to improve the pregnancy rate in aged women, cut~     down their abortion rate 、fetal birth with abnormal chromosome, and the risk of pregnancy~     termination after the prenatal diagnosis, reduce their pain of body and mind, the~     investigators will carry out this study. This is a prospective randomized controlled study of~     preimplantation genetic screening with Next generation sequencing technology. The embryos~     with more developmental potential and normal chromosomes should be selected. There is no~     related studies in Chinese. Most international research are limited to fluorescence in situ~     hybridization (FISH) technique, not on the embryo chromosome comprehensive screening. So~     there is no evidence of the effects of PGS on advanced age women.~      This study is to compare the outcomes between the advanced age women with two methods~     respectively. After blastocyst culture, blastocysts will be transferred in the control group.~     In the Preimplantation Genetic Screening (PGS) group, blastocyst embryo trophoblast biopsy~     will be performed and chromosome screening with Next generation sequencing（NGS） technology,~     at the same time, the blastocysts will be frozen, then the blastocysts with normal chromosome~     will be thawed and transferred. The investigators expect that, in PGS group live birth rate~     、cancellation rate and pregnancy rate are higher than in control group; abortion rate is~     lower than that of the control group.~   "
53359|NCT02868515|"~     The objective of this study is to examine the effects of 2 servings of hot cereal per day~     over 2 weeks on digestive health in children that typically eat low fiber diets.~   "
53360|NCT02868502|"~     The purpose of this study is to investigate the effect of trabeculectomy, glaucoma drainage~     devices, cyclophotocoagulation and ocular hypotensive eye-drops on IOP elevation with~     postural change from the sitting to supine positions in eyes with open-angle glaucoma.~      Patients will be assigned to the different study groups according to their past ocular~     history. Interventions are similar to all study group and no medical therapy alteration will~     be made.~   "
53361|NCT02868489|"~     The hypothesis is to determine the effect of bacillus coagulans and galactomannans~     (LactoWise®) administration on microbiota of obese patients undergoing sleeve gastrectomy by~     observing standard protocol measurements in patients following sleeve gastrectomy: blood~     markers and weight, in addition incorporating the Gastrointestinal Quality of Life Index~     (GIQLI)~   "
53362|NCT02868476|"~     Clinical and subclinical thyroid disease is usually used to describe patients with mild~     symptoms correlated to hyperthyroid or hypothyroid state. Therapeutic decision for clinical~     and subclinical thyroid dysfunction should be considered individually. But long term outcome~     for treatment of such functional and structural thyroid diseases had not been recorded~     delicately in Taiwan. Further investigations should be observed in the future.The purpose of~     this study is aiming for early prevention and detection the potential risk factors for~     thyroid diseases in Taiwan.~   "
53363|NCT02868463|"~     The purpose of this study is to characterize bladder urinary oxygen tension (BUOT) in women~     whose urinary microbiomes contains at least one anaerobic bacterial species versus women~     whose urinary microbiomes do not contain anaerobes.~   "
53417|NCT02867761|"~     The study hypothesis is that symptomatic current and former smokers with spirometric values~     within the normal range (post-bronchodilator FEV1/FVC≥0.70 and post-BD FVC ≥ 80% predicted~     [to guard against restrictive lung disease]) will still derive symptomatic benefit from~     long-acting bronchodilator therapy even though they are excluded from current GOLD guideline~     recommendations.~   "
53364|NCT02868450|"~     In 2012, a previous work showed that T. whipplei is a common bacterium detected in various~     situations. A large part of the population is therefore exposed to a T. whipplei but there is~     that some people probably with immunological and genetic factors predisposing which develop a~     disease. The association teams with experience in HLA-typing will allow us to better identify~     patients with a risk of chronic complication.~      The main aim of this study is to evaluate if the HLA-DRB13 and/or HLA-DQB106 typing in~     patients are risk factors of chronic infection with T. whipplei (defined by classic Whipple~     disease and/ or, endocarditis and/or encephalitis).~   "
53365|NCT02868437|"~     This prospective, randomized, controlled study evaluates the efficacy of self-crosslinked~     hyaluronic acid gel to prevent the development of de-novo intrauterine adhesions following~     curettage for retained product after second trimester abortion. One group of participants~     will underwent curettage plus intrauterine application of self-crosslinked hyaluronic acid~     gel while the other group will underwent curettage alone (control group).~   "
53366|NCT02868424|"~     Early Phase I Study of the Safety and Preliminary Efficacy of Human Fetal Retinal Pigment~     Epithelial(fRPE) Cells Subretinal Transplantation in Age-Related Macular Degeneration(AMD)~     Patients~   "
53367|NCT02868411|"~     A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the~     diagnosis in less than two hours of traveller's fever caused by known pathogens, close to the~     reception of Emergency service. In this instance 30% of patients have no etiological~     diagnosis after the POC traveller's fever tests .~      The objective of this study is to implement a new diagnosis strategy relying on the~     hypothesis that a rectal swab would improve the etiological diagnosis of traveller's fever of~     at least 10%.~   "
53368|NCT02868398|"~     This study monitors the efficacy and safety of Golimumab in maintaining deep remission and~     quality of life in Ulcerative Colitis patients in deep prolonged remission with Infliximab.~     Patients will be followed up for one year and they will be assessed with biochemical tests~     (C-Reactive Protein , Full Blood Count , Faecal Calprotectin),endoscopic evaluation (MAYO~     Score) and finally histologically.~   "
53369|NCT02868385|"~     An open label, randomized controlled trial of single vs. multiple treatments of praziquantel~     in intestinal African schistosomiasis in Côte d'Ivoire~      This study aims to determine the efficacy of repeated (up to four times) praziquantel~     treatment against S. mansoni infection in school-age children from Côte d'Ivoire using the~     traditional Kato-Katz thick smear technique, but also with more accurate and non-invasive~     antigen- and DNA-detection methods.~   "
53370|NCT02868372|"~     The study has 2 groups. Group A in which the subcutaneous tissue will be swabbed with 10 cc~     of undiluted 10% povidone iodine and will not be mobbed. Group B ; No swabbing. Women in both~     groups will be followed up during hospital stay and outpatient clinic visits a week and a~     month after cesarean delivery for surgical site complications which will be evaluated by the~     researcher.~   "
53371|NCT02868359|"~     The purpose of this study is to evaluate the effect of pregabalin on patient reported~     outcomes compared with conventional analgesic care in chronic cervical pain patients with~     accompanying upper limb radiating pain (neuropathic component) treated in primary care~     settings under routine clinical practice.~   "
53372|NCT02868346|"~     A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the~     diagnosis in less than two hours of sexually transmitted infections caused by known~     pathogens, close to the reception of Emergency service. In this instance 30% of patients have~     no etiological diagnosis after the POC sexually infection transmitted tests .~      Most sexually transmitted infections can be diagnosed from an anal swab which is not~     routinely performed. In this study, we suggest to test the hypothesis that anal swab in~     addition to the routine genital swab would increase by at least 5% the diagnosis capacity of~     sexually transmitted infections after the POC tests.~   "
53373|NCT02868333|"~     Background: Most children with primary immune deficiency (PID) now reach adulthood. However,~     few studies have evaluated their health status and health related quality of life (HRQoL).~      Objective: To investigate long-term morbidity, the French Reference Center for PIDs initiated~     a prospective multicenter cohort: the F-CILC (French Childhood Immune deficiency Long-term~     Cohort). The data collected will be used to assess the physical health condition of patients~     who reached adulthood and the impact on their quality of life.~      Methods: Patients are asked to complete health status questionnaires. A severity score~     (grade1 [mild] to grade 4 [life-threatening]) is assigned to each health condition. The~     HRQoL of patients is compared to age- and sex-matched French normal values using the SF36~     HRQoL questionnaire.~      Capsule summary. This will be the first study of adult survivors of childhood PID describing~     how the burden of health conditions affect their quality of life.~   "
53374|NCT02868320|"~     This study was conducted at the teaching hospital of Misr University for Science &~     Technology. It aimed to examine the use of SMS technology in educating and monitoring~     diabetic patients in Egypt, and assess the impact of educational text messages on their~     glycemic control and self-management behaviors. Participants were randomized into an~     intervention and a control group. Intervention patients received an instruction booklet as~     well as daily educational and weekly reminder messages to better control their diabetes.~     Control patients received the same instruction booklet but no SMS messages. Both group~     patients took an HbA1c test at the beginning and end of the study period and were asked to~     measure their blood glucose once a week and record their readings into a monitoring table~     over 12 weeks. The primary outcome was the change in HbA1c levels, which was expected to be~     greater among intervention patients at the end of the study. Secondary outcomes included~     blood glucose levels, treatment and medication adherence, diabetes self-efficacy, rate of~     hospital/ER visits, frequency of blood glucose measurement, among others.~   "
53415|NCT02867787|"~     Botulinum toxin is used in musculoskeletal therapy routinely for 15 years. This is one of the~     most potent neurotoxins. It comes in 7 serotypes (A to G).Therapeutic application of~     botulinum toxin are mainly based on its ability to block the neuromuscular transmission by~     preventing the release of acetylcholine, creating paralysis muscle relative and reversible.~      It has been used in the treatment of cervical dystonia, migraine headaches, and an~     antinociceptive effect. The analgesic effect occurred even prior to the release muscular.~     Several randomized studies have been published about it. The investigators assume that~     intramuscular injection of botulinum toxin is effective in the treatment of tendinopathy~     rotator cuff.~   "
53375|NCT02868307|"~     Quality of life (QoL) measurements have become an important way to evaluate the treatments~     and care provided to patients with schizophrenia. Understanding determinants of QoL in~     schizophrenia is of importance for developing effective interventions that would improve~     patient functional and subjective well-being. A challenge in the interpretation of QoL~     measures, especially in longitudinal studies, is that QoL is self-reported by the patient and~     might be influenced by psychological phenomena such as adaptation to illness. An important~     mediator of this adaptation process is a response shift (RS), which involves changing~     internal standards, values and the conceptualization of QoL. RS can be divided into three~     phases 1) reconceptualization (i.e., a redefinition of QoL), 2) reprioritization (i.e., a~     change in the importance attributed to component domains constituting QoL) and 3)~     recalibration (i.e., a change in a patient's internal standards of measurements). Patients~     may change their frame of reference, rendering scores from different measurement occasions~     incomparable. An RS is a potential explanation when the QoL of an individual who has~     experienced a serious health event or chronic condition is similar to the QoL of a healthy~     individual. With an RS, the concept of QoL changes over time and cannot be compared~     longitudinally because of changes in internal standards, values, and/or concepts. True change~     may be over- or underestimated when a RS is present, leading to biased estimates of the~     magnitude of change.The objective is to examine whether a response shift, a change in the~     internal standards of a patient, occurs in patients suffering from schizophrenia and in their~     caregivers.~      This is a monocentric and propective design study, with inclusion of patients and caregivers~     on a 12-month period, and a follow up on a 12-month period.~      100 patients with schizophrenia and 100 caregivers~      Test approach (Response shift (RS) (pre-test - then-test), unadjusted effect (post-test -~     pre-test), and adjusted effect (post-test - then-test scores)) will be completed with other~     statistical approaches such as confirmatory factorial analysis, multilevel models and CART~     method.~   "
53376|NCT02868294|"~     Osteogenesis imperfecta (or brittle bone disease) is a rare genetic disease characterized by~     fragile bone and a low mass ossue, secondary to abnormal collagen synthesis. This is a real~     congenital osteoporosis. The prevalence of the disease is not known precisely, but it is 1 in~     10000 at 20000. There are many forms of osteogenesis imperfecta to classify patients with~     symptomatology minor to the patients with lethal form during the neonatal period. The main~     symptoms are dominated by fractures and bone deformities, particularly in the lower limbs.~     Bisphosphonate medication is used for over 10 years to reduce the number of fractures.~     However the long-term effects are not known to date, not allowing even to establish proof of~     the benefit risk. Thus unable to process all of these patients and over a long time, these~     drug treatment leaves much therapeutic solutions to surgery. The goal of surgery is to treat~     fractures, treat bone deformities and prevent fractures future. In the long bones of the~     limbs, the only effective techniques are intramedullary nailing. The majority of realized~     nailing nailing are either sliding or telescopic enabling having a reinforced bone of an~     intramedullary osteosynthesis material over its entire length during the period of bone~     growth. It has been shown that the technique of the sliding nailing was inexpensive but~     reliable especially before the age of 5 years. After that age, all are telescopic nailing~     nailing. The first telescopic nail described is the Bailey-Dubow nail still widely used in~     France. However, the number of complications relating to its use is important. Thus, there~     are 8% of disunity equipment and 33 to 72% of the nail migration forcing him to change one or~     more times during growth. A new nail presented at the French orthopedic company in 2005 and~     Fassier Duval reported a much lower complication rate because the rate of nail migration is~     only 9%, without opening the knee joint, which is not possible with the highlight of~     Bailey-Dubow.~      It is proposed to conduct a prospective series of 10 nailing the lower extremities with this~     nail Fassier-Duval in patients with osteogenesis imperfecta and compare the results with a~     series of patients already treated with Bailey-Dubow nails in order to highlight the~     advantages and disadvantages of using of such a nail.~   "
53377|NCT02868281|"~     This study is aimed to evaluate the effectiveness of Asthma Control Test (ACT) guided~     treatment compared with usual care in asthma subjects in China. It is designed to assist~     Chinese subjects and physicians improving adherence to the guidelines through the inclusion~     of the ACT in the patient's asthma management plan. This is a prospective, multicentre,~     cluster-randomized, open-label 24-week study. In this cluster-randomization design, each~     study center, considered as a cluster, will be randomized to either ACT guided treatment~     group or control group (usual care group). For the subjects who are recruited in the ACT~     centers, they will be treated based on the ACT score. If ACT score are equal to (=) 25 for~     more than equal to (>=) 3 months then the treatment will stepped-down; if ACT score >=20,~     less than (<) 25 or ACT=25 for <3 months then there will be no change and if ACT score less~     than (<=) 19 then the treatment will stepped-up. For subjects who are recruited in the~     control centers, they will be treated based on doctor's subjective judgment. Assignment to a~     treatment will not occur, as no treatment intervention is provided for this study. A total of~     528 asthma subjects are planned in the study. The randomization will be stratified according~     to the Tier of the hospitals (Tier 3 verses Tier 2).~   "
53378|NCT02868268|"~     This proposal sets forth the platform for a Precision Medicine clinical trial through the New~     Approaches to Neuroblastoma Therapy (NANT) consortium. The plan is to utilize NANT's~     established multi-institutional infrastructure and Translational Genomics Research Institute~     GEM sequencing platform for acquisition and gene panel sequencing of relapsed biological~     specimens in relapsed/refractory neuroblastoma (rNB) including those obtained from the bone,~     bone marrow or soft tissue. Our primary aim is to identify subgroups of rNB patients who have~     potentially targetable genetic (ALK, MAPK pathway, Metabolic-related genes) and/or~     immunologic (tumor-associated macrophage infiltration and/or programmed death ligand [PD-L1]~     expression) biomarkers in rNB. Additional potential novel biomarkers will also be evaluated~     and reported in this cohort of patients.~   "
53379|NCT02868255|"~     project is to study and develop anti-Signal Regulatory Protein α (SIRPα) antibodies (Ab) as a~     new immunotherapy strategy in cancer.~      Samples harvested from hepatocellular carcinoma (HCC) and ovarian cancer patients will be~     used in evaluation of the SIRP-CD47 expression and of the effect of the anti-human Signal~     Regulatory Protein (hSIRP) Ab on various cellular types from patients and healthy volunteers.~   "
53380|NCT02868242|"~     The primary objectives of this study are to evaluate the efficacy, safety, and tolerability~     of ledipasvir/sofosbuvir (LDV/SOF) in treating hepatitis C virus (HCV) infection in pediatric~     participants who are undergoing cancer chemotherapy.~   "
53381|NCT02868229|"~     This is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety,~     pharmacokinetics, and pharmacodynamic effects of multiple doses of COR-001 or placebo~   "
53409|NCT02867865|"~     Locally advanced Gall bladders cancers not amenable for curative resection are often treated~     with chemotherapy alone which is the current standard of care. Randomized trials have shown~     survival benefit with combination chemotherapy in gallbladder cancers. Gallbladder cancer is~     not common western world and thus there is lack of evidence regarding the impact of~     neoadjuvant or concurrent chemo-radiation in this cancer.Use of neoadjuvant treatment with~     chemotherapy alone or chemoradiotherapy has shown to downsize these tumors to safely undergo~     R0 resection in few published studies. Also if the patients develop distant metastasis during~     this neoadjuvant therapy they can be spared of unnecessary surgery.~      In a pilot study of 28 patients by Engineer et al conducted at Tata Memorial centre treated~     with neoadjuvant concurrent chemoradiation the investigators could achieve R0 resectability~     rate 0f 47% with a median overall survival (OAS) and progression free survival (PFS) of 35~     and 20 months for the patients undergoing R0 resection.~      In this study the investigators intend to compare the effects of using neoadjuvant~     chemotherapy alone vs. neoadjuvant chemoradiation and chemotherapy for locally advanced gall~     bladder cancers in terms of down staging and overall survival.~   "
53382|NCT02868216|"~     Stress, anger and depressed humor can operate as a trigger to an Acute Coronary Syndrome.1 It~     is often found in the literature that patients refer excessive anger, anxiety, sadness, pain~     or acute stress promptly before the acute myocardial infarction (AMI) onset, and recent~     meta-analysis report a strong association between the occurrence of AMI and many of these~     acute emotions.2 According to Mostofsky, Maclure, Tofler, Muller and Mittleman3 the risk of~     suffering an AMI doubles after anger burst episodes when compared to another experienced~     situations.~      Anger is a common manifestation of psychological stress,4 and has been considered as an~     hypothesis that this emotion could trigger off an atherogenic process through several~     mechanisms.5-9 Evidences even suggest that hostile people that inhibit their anger expression~     are more prone to develop coronary atherosclerosis.10~      Coronary atherosclerosis features narrowing of coronary arteries on account of endothelial~     thickening caused by the build up of atheromatous plaques.11 It is a process characterized by~     inflammatory and fiberproliferative response of the artery wall, caused by continuous~     aggression to its surface and whose thickening, evoked by the evolution of fat streaks~     atherosclerotic lesions, until fiber plaques is quite slow.12~      Vascular alterations present in atherosclerosis derive from some essential processes:~     endothelial dysfunction, that has an early establishment and alters vase responsiveness,~     leading to vessel constriction,13 coronary blood flood disorders, 13,14 atherosclerosis and~     thrombosis evolution. Endothelial dysfunction also results in the loss of natural~     anti-thrombotic properties involved in the endothelium patency.14~      According to a study performed by our group in the Hemodynamics Sector of the Cardiology~     Institute of Rio Grande do Sul and recently published in the International Journal of~     Cardiology, anger management was significantly lower among patients with CAD when compared to~     those without CAD, and the occurrence of major cardiovascular events (MACE) was significantly~     higher in patients presented with lower anger control. Both associations were independent~     from traditional risk factors, occurrence of previous events or another anger aspects.15~     Thus, this study was designed in order to evaluate the effect of the cognitive training to~     anger management and control on endothelium-dependent vasodilation of the arm artery in~     patients with acute myocardial infarction with ST segment elevation submitted to primary~     coronary intervention. Secondary objectives comprehend the assessment of the this treatment~     influence on the incidence of recurrent cardiovascular events in these patients.~   "
53383|NCT02868203|"~     This study evaluates the completeness of strut coverage and vessel wall response, at~     different time points (3-6-12 Months), following CordimaxTM stent implantation in patients~     with non-ST elevation acute coronary syndrome~   "
53384|NCT02868190|"~     This study objective is to evaluate the intraocular pressure (IOP) lowering effect of two~     trabecular micro-bypass stents (iStent inject) in eyes of subjects with primary open-angle~     glaucoma on one topical hypotensive medication~   "
53385|NCT02868177|"~     Given the data on the active ingredients of Totum-63, this research aims to evaluate the~     effect of its chronic consumption (24 weeks) on glucose and lipid homeostasis and especially~     on fasting plasma glucose in volunteers with abdominal obesity associated with impaired~     glucose tolerance or untreated type 2 diabetes and hypertriglyceridemia. This clinical study~     is designed to estimate the effect of Totum-63, active ingredient of Valedia, on several~     glucose and lipid homeostasis related parameters since these data are still unknown for this~     specific dietary supplement formula. Collected data will provide more reliable information~     which may be used to plan a subsequent larger main study.~   "
53386|NCT02868164|"~     The study will be conducted in the Department of Hepatology, Institute of Liver & Biliary~     Sciences, New Delhi. As a part of this study history will be taken and clinical examination~     will be done. Subjects will be screened for diagnosis of NASH (Non Alcoholic Steatohepatitis)~     cirrhosis. If subjects are found to have NASH (Non Alcoholic Steatohepatitis) cirrhosis, they~     will be chosen to receive stool from healthy donor, which is voluntarily donated by a healthy~     donor related or unrelated to the subjects and the stool will be prepared using standard~     guidelines. The prepared sample of stool, about 50 ml will be instilled into proximal small~     intestine by way of a thin and soft tube inserted through nose. This administration of~     sample, 50 ml daily will occur once a month every month for 6 months. The liver function~     parameters will be assessed and thereafter at 1 month and 3 months & subjects will be~     clinically assessed for improvement or worsening.~   "
53387|NCT02868151|"~     The surrounding controversies both advocating and simultaneously opposing the use of vitamin~     C, mostly extrapolating animal models to human models, it has not been used individually to~     assess the severity of oral mucositis during chemoradiotherapy.~      The present study is undertaken to evaluate the effect of vitamin C oral supplements in~     assessing the severity of oral mucositis during chemoradiotherapy for oral cancer.~   "
53388|NCT02868138|"~     The aim of this single-center observational study was to evaluate quality of life, clinical~     effectiveness, and satisfaction in pediatric and young adult patients with sickle cell~     disease receiving hydroxyurea.~   "
53389|NCT02868125|"~     There is no standardized protocol regarding the post-operative radiographic follow up of~     patients that sustain pertrochanteric hip fractures and are treated with closed reduction and~     internal fixation. The policy in the investigator's institution as in other hospitals is to~     conduct a radiogram of the operated hip during the first days following operation after the~     patient bore weight on the fixated femur. The investigator's goal is to asses the added value~     of this policy and to offer recommendations regarding this specific followup component.~   "
53390|NCT02868112|"~     The purpose of this research study is to pilot test a transdisciplinary intervention that~     integrates both geriatrics and palliative care with routine oncology care for older adults~     with incurable cancer. The investigators will explore their perceptions of the supportive~     care needs of older patients with cancer. Using these data, the investigators will finalize~     the transdisciplinary intervention and perform a pilot, randomized trial of the~     transdisciplinary intervention versus usual care in patients age ≥65 with newly diagnosed,~     incurable cancer.~   "
53391|NCT02868099|"~     The objective is to evaluate the efficacy and safety of romiplostim for injection in adlut~     subjects with persistent or chronic primary immune thrombocytopenia (ITP).~   "
53410|NCT02867852|"~     Carcinomas of the salivary glands (SGCs) are rare tumors. Some selected salivary gland~     histotypes such as salivary duct carcinomas (SDC) and adenocarcinomas, NOS (not otherwise~     specified) distinguish themselves for the expression of androgen receptors (AR), which is~     reported in 21% to 43% of the cases. Thus, similarly to prostate cancer (Pca), androgen~     deprivation therapy (ADT) has been suggested to be beneficial in patients with recurrent or~     disseminated AR-expressing disease. No other therapy except palliative chemotherapy is~     available after progression on ADT, thus underling the necessity of alternative therapeutic~     approaches.~   "
53411|NCT02867839|"~     The purpose of the study is to evaluate the efficacy and safety of S-1 plus Oxaliplatin~     versus S-1 only as adjuvant chemotherapy after curative distal gastrectomy in patients with~     locally advanced gastric cancer.~   "
53412|NCT02867826|"~     The aim of this study is to compare the visualization rates of the ampulla of Vater using~     forward- viewing endoscopes with or without cap attached to the distal end in the same~     patient.~   "
53392|NCT02868086|"~     The treatment of neovascular age-related macular degeneration (ARMD) is a major issue of~     public health. The therapeutic arsenal has widely grown throughout the years with the~     emergence of intra-vitreous anti-angiogenic treatments, under different surveillance~     protocols. The PRN surveillance (pro re nata: an on-demand treatment with monthly~     follow-up) allows a faster re-injection in case of neovascular relapse in order to maintain~     the best visual acuity. This therapeutic protocol is guided by the sub-retinal neovascular~     signs of activity. The monitoring is done during common practice via OCT B scans showing~     indirect signs of neovascular activity (exudation signs). OCT retinal imaging has been~     recently enriched with new programs allowing the visualization of sub-retinal neovessels~     without the use dyes (OCT angiography). The OCT angiography is automatically done by a~     program using standard OCT sections. During the monitoring of a patient using the OCT A, the~     signs of renewed neovascular activity are represented by an arterialization or the~     development of an arteriole network of the neovessel with the reappearance of a hyper~     reflective flow after a neovascular regressive phase. Indeed, the visualization of neovessels~     during the monitoring by Angio-OCT may lead to therapeutical modifications (anticipation of~     the injections). Knowing that the injection time-table of ARMD patients treated with~     anti-angiogenics is determined by sub-retinal neovascular signs of activity. This activity is~     evaluated during routine clinical practice by very specific signs, observable on OCT B scans.~     The hypothesis of this study is that the search of activity sins on the Angio-OCT, a new~     technic of image analysis performed on the OCT, may modify this injection time-table, with an~     impact of the patient's visual acuity.~   "
53393|NCT02868073|"~     A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Determine the~     Safety and Immunogenicity of an Adenoviral-Vector Based Norovirus Vaccine (VXA-G1.1-NN)~     Expressing GI.1 VP1 and dsRNA Adjuvant Administered Orally to Healthy Volunteers~   "
53394|NCT02868060|"~     The objective of evaluating the pharmacokinetics and pharmacodynamics of romiplostim in~     patients with immune thrombocytopenia.~   "
53395|NCT02868047|"~     There is tremendous variability in regard to provider perception of findings on EUS for~     chronic pancreatitis. This study performs tandem EUS exams between expert endosonogrpahers to~     determine the validity of minimal standard criteria.~   "
53396|NCT02868034|"~     Research on spinal manipulative therapy for individuals with low back pain has been hampered~     by a lack of understanding of which of the physiologic effects produced by spinal~     manipulation are related to clinical benefit, and how these effects can be used to optimize~     treatment outcomes. Prior research has identified physiologic effects that relate to the~     clinical benefits from spinal manipulation treatment. The goal of this project is to examine~     strategies to use these effects to identify optimized treatment protocols. The results of~     this project will provide critical information for future clinical trials related to spinal~     manipulation.~   "
53397|NCT02868021|"~     This pilot study will investigate the effects of blood flow restriction (BFR) exercise for up~     to 4-6 weeks prior to total knee arthroplasty (TKA) surgery in older patients to measure~     clinical outcomes such as strength, lower extremity function, and pain.~   "
53398|NCT02868008|"~     Microsurgical resection for eloquent arteriovenous malformations (AVMs) remains challenging.~     Currently, there are only two grading systems concerning pretreatment assessment of brain~     AVMs: the Spetzler-Martin grading system proposed by Spetzler and Martin in 1986 and the~     supplementary grading system proposed by Lawton in 2010. Controversies exist regarding the~     treatment timing and treatment modalities for eloquent AVMs. Till now, there is no clinical~     trial concerning the efficacy of multimodal magnetic resonance imaging techniques in~     assessing the surgical risk for eloquent AVMs. The investigators assume that multimodal~     imaging-based grading system is superior to the classic Spetzler-Martin grading system and~     the supplementary grading system in predicting the surgical risk for eloquent AVMs.~   "
53399|NCT02867995|"~     The purpose of this study is to determine whether glaucoma drop aids will be cost-effective~     in delivery of ophthalmic medications by improving medication compliance, visual function,~     and even decreasing medication waste in the patient population at Boston Medical Center~   "
53400|NCT02867982|"~     This is a two-year prospective randomized clinical study to to evaluate whether the gingival~     thickness and insertion depth of dental implants have any influence on marginal bone levels~     changes around platform switched implants.~   "
53401|NCT02867969|"~     This is a piloting study using continuous motor training provided via whole body-controlled~     video games (exergames) to establish proof-of-concept evidence that such training leads to~     motor and neural changes in pre-manifest subjects with spinocerebellar ataxias (SCA).~   "
53402|NCT02867956|"~     The purpose of the study is to evaluate the efficacy and toxicity of apatinib in patients~     with platinum resistant or refractory ovarian cancer when combined with etoposide.~   "
53403|NCT02867943|"~     As an approximate of the difference between venous-to-arterial CO2 tension (∆PCO2), ∆PCO2 is~     proportional to CO2 production and inversely related to cardiac output (Fick equation).~     Anaerobic CO2 production is thought to occur when tissue hypoxia is present, mostly because~     of buffering of bicarbonate ions by the protons produced in excess secondary to the~     hydrolysis of adenosine triphosphate. Therefore ∆PCO2 has been proposed as a marker of tissue~     hypoxia.~   "
53404|NCT02867930|"~     The purpose of the study is to compare dexmedetomidine and ketofol to find a suitable~     alternative for moderate sedation in out-patient diagnostic trans-esophageal~     echocardiography.~   "
53405|NCT02867917|"~     The purpose of this study is to compare 1. taste and 2. texture/palatability of Metamucil~     orange®, Volcolon® and generic orange psyllium.~   "
53406|NCT02867904|"~     The purpose of this study is to assess the efficacy of intra-operative subacromial~     corticosteroid injections in patients undergoing arthroscopic shoulder surgery on quality of~     life scores and activity level when compared to a control group.~   "
53407|NCT02867891|"~     In this trial the investigators will evaluate the outcomes of 4 pre‐defined groups of~     individuals according to the therapeutic intervention. The investigators will determine the~     outcome of each group by monitoring the survival and the response rates of patients with~     FLT3-ITD AML relapse after allo-HSCT.~   "
53413|NCT02867813|"~     The primary clinical hypothesis is that long-term exposure of evolocumab will be safe and~     well tolerated in subjects with clinically evident atherosclerotic cardiovascular disease~     (CVD).~   "
53418|NCT02867748|"~     Abstract:~      Urinary Stress Incontinence (USI)- is a discomforting condition that negatively affects the~     quality of life of many female individuals and frequently treated by surgical intervention.~     The incontinence curative operations revolutionized at 1995, with the introduction of the~     first retro-pubic sub-mid urethral synthetic sling, firstly named Intra-Vaginal Sling-plasty~     (IVS) and then Tension Free Vaginal Tape (TVT), by Ulmsten and Petros. This was later~     proposed to be done trans-obturatorly (TOT), for avoiding operative bladder injuries.~      Among other peri-operative complications attributed to the commonly used anti-incontinence~     TOT are the thigh and groin pain. These pains are subjects of concern for patients and~     physicians worldwide. Another, rare yet very disturbing post-operative complication is~     erosion of the polypropylene tape into the vagina. TOT palpation at vaginal examination was~     claimed to be a predictive sign for future erosion of the polypropylene tape into the vaginal~     cavity.~      This current study aims to compare TVT-Abbrevo procedure (12 cm polypropylene tape, Ethicon~     J&J Somerville, NJ, USA ) to Serasis procedure (softly knitted monofilament non-absorbable~     polypropylene, Serag-Wiessner, Naila, Germany) for the cure of USI. The purpose of this study~     is to evaluate the feasibility, the safety and the cure rate of both procedures, as well as~     documenting the post-operative immediate, and long term thigh and groin pain levels, and~     dyspareunia. This study is aimed to evaluate the palpability of the implanted tapes at~     vaginal examination and the possible relation of this to further vaginal tape exposure.~      Investigators hypothesized that using Serasis tape, which is made of a softer polypropylene~     material than rather rigid TVT-Abbrevo polypropylene tape might result in lower pain levels~     at the short and long term post-operative course, as well as to reduced tape palpability and~     exposure to the vaginal cavity. investigators believe that favorable results for this study~     might improve patients' post-operative quality of life and overall satisfaction.~      Keywords: Serasis, TVT-Abbrevo, USI, pain, groin, thigh, dyspareunia, safety, urinary stress~     incontinence, sub mid urethral sling, trans-obturator, TOT, Intra-Vaginal-Sling plasty.~   "
53419|NCT02867735|"~     To evaluate the safety and tolerability of LKA651 in patients with macular edema from~     diabetic macular edema (DME), neovascular age-related macular degeneration (AMD), or retinal~     vein occlusions (RVO)~   "
53420|NCT02867722|"~     In this study, daylight PDT will be administered to interested patients at~     Dana-Farber/Brigham and Women's Cancer Center. Daylight PDT has been shown to be an effective~     and painless alternative to traditional PDT. Daylight PDT involves application of the~     photosensitizer in the physician's office followed by exposure to daylight.~   "
53421|NCT02867709|"~     This study will evaluate the efficacy, safety, and tolerability of 2 doses of ubrogepant (25~     and 50 mg) compared to placebo for the acute treatment of a single migraine attack.~   "
53422|NCT02867696|"~     The primary aim of this study is to examine the effect of applying a minimal contact~     technology-based intervention (TECH) at 1-year post-bariatric surgery on weight change~     compared to Standard Care. Forty participants at 1-year post bariatric surgery will be~     randomized to TECH or Standard Care for a period of 6 months (12 to 18 months post-surgery).~     Analyses will be conducted to compare these interventions for differences in body weight,~     body composition, fitness, physical activity, engagement, psychosocial measures, and~     intervention cost and cost-effectiveness of each approach. TECH will consist of a wearable~     monitor that provides feedback on energy expenditure and physical activity, electronic~     tracking of dietary intake, and integration of an electronic scale to provide comprehensive~     feedback to the participant on all components of weight management. TECH participants will~     receive a monthly telephone call from the intervention staff to provide guidance on their~     weight management efforts.~   "
53423|NCT02867683|"~     This study evaluates the use of vibrotactile feedback to traditional vestibular treatment~     protocols. Half the patients will have vibrotactile feedback added to their treatment~     protocols while the other half will undergo traditional vestibular treatment without~     vibrotactile feedback.~   "
53424|NCT02867670|"~     TMS is a non-invasive brain stimulation technique, which can be used to change the activity~     of a person's brain cells without needles or surgery. In this study, the invesigators are~     interested in the brain's ability to adapt (also called neuroplasticity) and regain~     language functioning after a stroke—specifically, they want to determine whether how a~     person's brain responds to TMS in the short term can be used to predict how well they will~     recover language abilities in the long term.~   "
53425|NCT02867657|"~     The purpose of the study is to determine whether a five day mindfulness retreat in nature can~     increase measures of attention and self-compassion, and reduce stress among bachelor students~     at Danish Universities and University Colleges. Secondary whether the expression of~     inflammatory markers can be reduced .~      It is the hypothesis that perceived stress is reduced and the expression of genetic markers~     of inflammation is reduced after a five day mindfulness retreat.~   "
53426|NCT02867644|"~     The hypothesis is to assess the contribution of conversational hypnosis on anxiety of~     patients who undergoing for a preoperative breast tracking and improve their care~   "
53427|NCT02867631|"~     The Postpartum Weight Management Study is a true community-academic collaboration, bringing~     together Maternity Care Coalition (MCC) staff and the investigator, Dr. Charmaine Smith~     Wright from the University of Pennsylvania to address the needs of postpartum moms. The~     project is an innovative intervention to help moms lose weight after the birth of their baby.~     Helping mothers control their weight during pregnancy and beyond can help both mother and~     baby avoid later obesity and cardiovascular disease. Although all women are at risk for~     retaining the weight gained during pregnancy, this problem is amplified for low-income,~     minority women. The holistic approach aims to prevent postpartum weight retention and~     increase breastfeeding duration with a multi-component, low-cost intervention that provides:~     1) Motivational appeals delivered in text message format; 2) Environmental aides, such as a~     baby carrier to combine exercise with infant care, and a pedometer to accurately measure~     exercise at home; 3) Enhanced peer support, including home visits and group classes with~     other mothers; and 4) Task-oriented professional support from nutrition and lactation~     experts, who assist women in developing a personalized health plan. The effectiveness of the~     intervention will be evaluated using a randomized control methodology among clients of MCC.~   "
53428|NCT02867618|"~     This is an open label, phase I/II, dose-escalation study in the initial phase I followed by a~     phase II.~      The primary objective of the phase I is to determine the maximum tolerated dose (MTD) and~     dose limiting toxicity (DLT) of the combinations of TGR-1202 and carfilzomib in participants~     with relapsed and refractory (R/R) non-Hodgkin lymphoma (NHL) and Hodgkin lymphoma (HL). The~     safety and toxicity of this combination will be evaluated throughout the entire study.~      If the combination of TGR-1202 and carfilzomib is found to be feasible and an MTD is~     established, the phase II part of the study will be initiated.~      Phase II will consist of a 2-stage design of the combination of TGR-1202 and carfilzomib for~     participants with R/R NHL.~   "
53429|NCT02867605|"~     The purpose of this study is to evaluate whether oral HA35 supplementation changes the normal~     intestinal bacteria, increases intestinal protection, decrease intestinal inflammation and~     permeability, and to assess any health benefits and confirm the safety profile of HA35.~   "
53430|NCT02867592|"~     This phase II trial studies how well cabozantinib-s-malate works in treating younger patients~     with sarcomas, Wilms tumor, or other rare tumors that have come back, do not respond to~     therapy, or are newly diagnosed. Cabozantinib-s-malate may stop the growth of tumor cells by~     blocking some of the enzymes needed for tumor growth and tumor blood vessel growth.~   "
53431|NCT02867579|"~     Described in the 1970's, pregnancy denial occurs as the un-consciousness of being pregnant~     for several months or throughout the entire period. Body transformations are most of the time~     not clearly noticeable. The prevalence of this symptom could represent 2 or 3 births over~     1000. The definition of pregnancy denial remains unclear due to the different nosological~     classifications used. There is no international consensus. Encountered terminologies are~     different from on author to another: pregnancy denial, pregnancy negation. The difficulties~     to define properly pregnancy denial accurately reflect the clinic heterogeneity of our~     patients when practicing on a daily basis. As a result, it is difficult to find predictive~     factors: any women of childbearing age, regardless her age, parity or social professional~     category, can be subjected to pregnancy denial. Several publications report observations of~     case of denial of pregnancy, few retrospective studies were realized, only two studies were~     interested in the future of the child, and no prospective study was interested in the future~     of the relation mother - child. The denial of pregnancy questions the maternal psychic~     functioning. No link between psychiatric disorder and denial of pregnancy was until then~     established. Our various clinical meetings, with mothers having presented a denial of~     pregnancy and reporting a difficult personal history with many breaks and events susceptibly~     traumatic, brought us to emit the following hypothesis: an insecure attachment of the mother~     would participate or at least would facilitate in the construction of a denial of pregnancy.~     These mothers would have a difficult access, even impossible for the infantile experiences,~     the essential experiences in the psychic reorganizations of the pregnancy that prepare the~     woman to accept her new functions of mother. The investigators hypothesize that the~     attachment and the development of the child, as well as interactions mothers-babies are~     disturbed when the woman presents a denial of pregnancy.~      The research will compare the maternal functioning in both constituted groups (group denial~     of pregnancy versus groups control), by estimating the type of maternal attachment, without~     omitting to look for a possible psychiatric pathology, and a personality problem at the~     mother.~      From the questioning on the psychodynamic considerations of the denial of pregnancy, and also~     on the future of the dyade mother-baby, the investigators construct a national program of~     clinical research called Attachment and pregnancy denial, with the participation of 13~     centers in France. This research is a prospective cohort examination with main objectives:~     study the impact of the denial of pregnancy on the pattern of attachment of the child, on the~     interactions of dyads mother-child and on the early development of the child with a 20-month~     follow-up. It's a multicenter case-control study with 13 centers (Reims, Strasbourg,~     Besançon, Nancy, Toulouse, Amiens, Troyes, Toulon, Limoges, Ile-de-France, Lille, Bordeaux,~     Paris 18ème), to find the maternal risks factors associated to pregnancy denial (secondary~     objectives).~      The main objectives of this study are: (i) studying the relationship between pregnancy denial~     and the attachment pattern of the child; (ii) studying the relationship between pregnancy~     denial and the early interactions of mother-infant dyads; (iii) studying the relationship~     between pregnancy denial and the early development of the child.~      The secondary objectives of this study are: (i) studying the relationship between the~     duration period from the pregnancy announcement to the delivery and the early development of~     a child, including the attachment pattern of a child, the early interactions of mother-infant~     dyads, (ii) looking for the risk factors associated to pregnancy denial, including the type~     of attachment, the existence of a personality disorders and/or a psychiatric pathology~   "
53432|NCT02867566|"~     The purpose of this study is to comparing the Efficacy and Safety between I-CHOP and R-CHOP~     in Untreated CD20-Positive Diffuse Large B-cell Lymphoma Patients.~   "
53433|NCT02867553|"~     Cutaneous lymphomas are the most frequent extranodal lymphomas after digestive lymphomas. A~     quarter are B-cell lymphomas. 80% of cutaneous B cell lymphomas are indolent cutaneous B cell~     lymphomas. These indolent cutaneous B cell lymphomas are characterized by good prognosis~     (survival rate at 5 years: 90%), but also by the frequency of cutaneous recurrences. The~     radiotherapy is currently the most widely used treatment, with complete response rate close~     to 100% for a lesion treated. However, it has limits when there are outset multiple lesions~     inaccessible to a single radiotherapy field (concerning one case in three), or during~     recurrences. In these situations, conventional chemotherapy is not recommended and~     multi-field radiotherapy is often used empirically, but its effectiveness has never been~     studied prospectively.~      Recently, retrospective studies with small numbers patients (totaling sixty patients)~     reported complete response rates of 80 to 100% with rituximab (anti-cluster of~     differentiation antigen 20 (CD20) antibodies) used as monotherapy in non-standardized~     treatment by intravenous with a recurrence rate of less than one case in three. These data~     suggest that rituximab by intravenous with a standardized initial cycle followed by a~     maintenance therapy could improve the prognosis of indolent cutaneous B cell lymphomas with~     multiple lesions or of recurrent lesions.~   "
53434|NCT02867540|"~     Nearly three-quarters of patients with Crohn's disease have small bowel involvement and 80%~     of them will have complications that will require a surgical procedure, usually an~     ileocolonic resection with ileocolonic anastomosis. The rate of recurrence at the anastomosis~     site and in the ileum after surgery, whether symptomatic or not, is high, at least 60% in one~     year and 80% within three years. The gold standard for monitoring being ileocolonoscopy,~     endoscopic surveillance is recommended in these patients, once between 6 to 12 months after~     surgery and then every 2 years.~      The MRI enterography is a validated technique for the assessment of small bowel Crohn's~     disease. The enterography MRI is a validated technique for the assessment of small bowel~     Crohn's disease. The MRI enteroclysis was evaluated in two studies compared to endoscopy,~     with excellent performance in terms of recurrence detection sensitivity and suggested as an~     alternative to it to avoid an invasive procedure repeated in these patients. The MRI~     enterography (without enteroclysis) does not provide as good distension of the bowel loops as~     MRI enteroclysis because it relies on the principle of oral ingestion prior to the~     examination of large amounts of liquid. However, it is much better tolerated by the patient,~     does not involve radiation that exists with enteroclysis, is much simpler to use and requires~     no special equipment to magnetic fields.~   "
53435|NCT02867527|"~     Few publications provide information on the natural history of glaucoma, outside of clinical~     trials do not always reflect what is observed in common situation for various reasons~     (specific selection criteria and sometimes restrictive, stronger motivations patients and~     physicians to comply with follow-up visits and prescribed treatments, etc.). Therefore, much~     information on the natural history of glaucoma are unknown to date (degradation rate of~     visual field and visual function over time, risk of blindness in the years following~     diagnosis, effects of various treatments to reduce intraocular pressure and preserving visual~     field deterioration, etc.). Obtaining such important data to improve the management of~     glaucoma patients (choice of treatment methods, identification of predictors of rapid change~     that can make choosing more aggressive treatment and more regular monitoring, etc.) requires~     the establishment of cohort of patients followed and treated with the methods usually used in~     current practice, and besides therapeutic trial.~   "
53436|NCT02867514|"~     The purpose of this study is to evaluate the effect of 10 sessions of anodal transcranial~     Direct Current Stimulation (tDCS - 1 mA) applied to left vs right CDLPF of tobacco-dependent~     subjects compared to the application of a placebo tDCS (sham procedure) on the craving, which~     is evaluated by the item 1 of Fagerström test between day 1 and day 10. Craving is also~     evaluated 1 month post-treatment.~   "
53437|NCT02867501|"~     The aim of the study is to assess if venous distension in patients with aneurysmatic~     arteriopathy is higher compared to patients with peripheral arterial occlusive disease (PAOD)~     and in controls.~   "
53438|NCT02867488|"~     The objectives will be to evaluate the dose-response between the amount of soybean oil in~     salad dressing and the absorption of: 1) carotenoids, phylloquinone, and tocopherols in salad~     vegetables; 2) retinyl palmitate formed from the provitamin A carotenoids, alpha- and~     beta-carotene.~   "
53439|NCT02867475|"~     Study 1:~      The investigator hypothesizes that the level of knowledge about the benefits of physical~     activity, physical activity level and physical fatigue level observed in cancer patients,~     would influence their beliefs about physical activity and their intention to engage in AP.~   "
53440|NCT02867462|"~     The medical teams are increasingly sought by patients to get the most possible information,~     probably expressed in a different form and thereby supplementing the information already~     received. Coulter et al. reached similar conclusions in their study of the writings of~     patient information documents. They point out, moreover, the best adaptation of the patients~     better informed compared to those with less or no information.~      This need for information varies over time. It is present before treatment begins, continues~     during treatment and persists after treatment. Given the specific features of radiotherapy,~     the manipulators are important interlocutors to participate in the accompanying caregiver~     time.~      In conclusion, the quality of information delivered to the patient has been poorly evaluated,~     let alone with validated tools in this area.~      The impact of information on the tolerance of the treatment also needs to be confirmed,~     knowing that an informed patient seems less anxious and better prepared for future treatment.~   "
53468|NCT02867098|"~     An open label comparison of concentration of the study medication administered intravenously~     (IV) versus subcutaneously (SC) in healthy volunteers.~   "
53559|NCT02865915|"~     This is a Phase 2b double-blind, randomized, parallel-group, placebo-controlled study of~     MLE4901 versus placebo in women with PCOS.~   "
53441|NCT02867449|"~     Cognitive behavior therapy is the most effective treatment of obsessive-compulsive disorder.~     However, the majority of treated patients remain symptomatic. The metacognitive therapy by~     Wells (1997) could achieve substantial gains in first pilot studies. The purpose of this~     study is to investigate this approach with a randomized controlled trial by comparing~     metacognitive therapy with exposure and response prevention for obsessive-compulsive~     disorder.~   "
53442|NCT02867436|"~     The primary aim of this pilot study is to test whether gluten-free diet (GFD) instituted in~     children shortly after onset of Type 1 Diabetes (T1D) can decelerate the decline in beta cell~     function as compared to age matched controls. Primary objective of the trial is the change in~     C-peptide area under the curve measured by mixed-meal tolerance test (MMTT) between group on~     GFD and standard gluten-containing diet.~      Secondary objectives are:~        -  Changes in immune parameters between gluten-free diet group and control group;~        -  Differences in fecal microbiome between children on normal diet and children on GFD;~   "
53443|NCT02867423|"~     The CyberKnife (CK) has been developed recently. This is a linear accelerator carried by an~     industrial robot. It has, due to its tumor tracking capabilities and high accuracy, an~     interest in irradiation (boost) of tumor site after conventional irradiation. The radiation~     boost is currently issued by electrons, protons or brachytherapy. These techniques require~     several fractions and are associated with cutaneous toxicities and aesthetic problems. CK has~     an interest in reducing the number of fractions and a reduction of dose delivered to the~     skin.~      CK has been used in a phase I protocol (CYBERNEO) with concomitant chemotherapy for~     inoperable breast tumors and has proven its effectiveness and safety of treatments.~      The investigator is considering conducting a Phase II protocol to a single dose of 8 Grays~     issued by CK for boost to the tumor site after conventional breast irradiation.~      The results, in terms of local control, will be evaluated on clinical monitoring.~   "
53444|NCT02867410|"~     Feeding problems are common among babies who are born preterm or who have medical conditions.~     It is not yet known which babies admitted to neonatal units are most at risk of feeding~     problems. Studies have shown that the degree of prematurity and the presence of additional~     health problems make feeding difficulties more likely. However, research does not always~     agree on which health problems are most associated with feeding problems and many studies on~     prematurity exclude babies with the most complex health problems. Additionally, not all~     babies with complex health problems and feeding problems are premature. This study aims to~     answer the question 'Is gestational age or medical status the better indicator of risk for~     feeding difficulties?'~      This research will study babies admitted to the Royal Preston Hospital Neonatal Unit in 2015~     using routinely collected data about stored on BadgerNet, a patient data management system.~     Coded data will be collected for the following variables: gestational age category (extremely~     preterm, very preterm, moderate-late preterm, term), medical status by number and type of~     bodily systems with health issues, and feeding outcome (full oral feeding by 37 weeks, 40~     weeks, before discharge, or discharged home with tube feeding).~      Appropriate statistical tests will be used to determine the presence or absence of~     correlation between gestation age and medical variables and feeding outcome. Information from~     this study will be used to inform neonatal service delivery (including Speech and Language~     Therapy referral criteria and caseload prioritization) and areas in need of further research.~   "
53445|NCT02867397|"~     The goal of the current study was to investigate the safety and determine the maximum~     tolerated dose (MTD) of S-1 in combination with oxaliplatin and epirubicin in patients with~     advanced or metastatic solid tumors.~   "
53446|NCT02867384|"~     This research study is studying a drug called obinutuzumab as a means of preventing chronic~     Graft vs. Host Disease (cGVHD).~   "
53447|NCT02867371|"~     The Archimedes System is an image-guided navigation system used to access tissue samples in~     the lungs. This study is being conducted to confirm the performance of the Archimedes System~     in patients who are scheduled for standard bronchoscopy to diagnose highly suspicious lung~     cancer or metastatic disease. Navigation to and sampling of the patient's lung cancer tumor~     is conducted.~   "
53448|NCT02867358|"~     The purpose of this study is to investigate clinical efficacy of KT07 capsule in alleviation~     of fever and other symptoms including nasal congestion, sore throat, cough, aches and pains,~     fatigue, headache, chills or sweats in subjects with acute uncomplicated influenza.~   "
53449|NCT02867345|"~     This study will evaluate the safety of PD-1 knockout engineered T cells in treating~     castration resistant prostate cancer (CRPC). Blood samples will also be collected for~     research purposes.~   "
53450|NCT02867332|"~     This study will evaluate the safety of PD-1 knockout engineered T cells in treating~     metastatic advanced renal cancer. Blood samples will also be collected for research purposes.~   "
53451|NCT02867319|"~     This phase I clinical study evaluates the safety of ACYW135 meningococcal polysaccharide~     vaccine in population aged 2-6, 7-17, 18-50 years old by the method of both passive and~     active surveillance.~   "
53452|NCT02867306|"~     The primary purpose of the study is to evaluate the effect of ASP1707 twice daily on the~     pharmacokinetics of once weekly oral methotrexate (MTX).~      This study will also evaluate the effect of MTX on multiple-dose pharmacokinetics of ASP1707,~     as well as safety and tolerability of coadministration of ASP1707 and MTX in patients with~     rheumatoid arthritis (RA).~   "
53453|NCT02867293|"~     Massive ascites is usually controlled over several weeks pre-operatively in liver transplant~     recipients with the risk of encephalopathy and peritonitis. We hypothesized that~     intra-operative drainage of ascites will be safe and avoids the inherent risks of~     pre-operative drainage.~   "
53454|NCT02867280|"~     This prospective multicenter non-randomized controlled study evaluates the efficacy and~     safety of treatment with Sorafenib (Nevaxar) in patients with hepatocellular carcinoma with~     microvascular invasion after radical resection compared to conventional therapies.~   "
53455|NCT02867267|"~     The purpose of this study is to determine whether thymalfasin is safe and effective in~     patients who have sepsis~   "
53469|NCT02867085|"~     The prospective BoHemE study is designed to evaluate the correlation between bone marrow~     function and skeletal health in elderly patients (>= 60 years) with or without pre-existing~     myelodysplastic syndromes (MDS).~   "
60419|NCT02776020|"~     The aim of this study is to determine efficacy of the CorrecDose device to continuously and~     non-invasively follow the changes in propofol concentrations in the participants' blood.~   "
53456|NCT02867254|"~     Pulpal and periodontal tissues are closely related and have similar microbiota that~     cross-contamination between the pulp and periodontal tissues.The aim of this study was to~     investigate the prevalence of isolated Candida albicans from periodontal endodontic lesions~     in diabetic and normoglycemic patients and their virulence in different atmospheric~     conditions. A case-control study was conducted on 15 patients with type 2 diabetes mellitus~     (G1) and 15 non-diabetics (G2), with periodontal endodontic lesions. Samples of root canals~     and periodontal pockets were plated on CHROMagar for later identification by polymerase chain~     reaction (PCR) and virulence test.~   "
53457|NCT02867241|"~     The primary goal of this research is to evaluate the effectiveness of an intervention for~     parents to reduce tobacco smoke exposure of young children~   "
53458|NCT02867228|"~     This study will evaluate the correlation between invasively measured parameters (work of~     breathing/power of breathing, resistance and elastance), derived using esophageal pressure~     measurements, and their corresponding non-invasive estimated values (noninvasive work of~     breathing/power of breathing, resistance and elastance), computed using airway pressure and~     flow measurements only.~   "
53459|NCT02867215|"~     The aim of this study was to compare the metabolic effects of consuming whole barley bread~     and whole wheat bread, in healthy subjects. Also, to investigate the effect of whole grain~     flour on mineral status.~   "
53460|NCT02867202|"~     This study was taken out to compare two mechanical devices (intrauterine balloon and~     intrauterine contraceptive device) in the therapy for intrauterine adhesions after~     hysteroscopic adhesiolysis. Participates were assigned into two groups by randomly.~   "
53461|NCT02867189|"~     Aims and objectives The purpose of this study was to develop an atlas to explore the effect~     of micro-instrument cleaning on the safety of cataract surgery.~      Background Cataract surgery safety is affected by many factors, the most influential of which~     is the quality of instrument cleaning. Previous studies focused on the reaction in the eye~     after cataract surgery. None offered a solution for manually cleaning ophthalmic~     micro-instruments or response data for surgical instruments after cataract surgery.~      Design The study was designed to collect quantitative data derived from postoperative ocular~     evaluation.~      Methods We developed an atlas that details micro-instrument cleaning that could be used to~     train nurses to have this skill. A total of 120 cataract patients were divided evenly into~     experimental and control groups. In the experimental group, cataract surgery was undertaken~     using microsurgical instruments that were cleaned by the atlas-trained nurses. In the control~     group, micro-instruments were used that had been cleaned by non-atlas-trained nurses. All the~     patients underwent the same postoperative tests: anterior chamber cell counts and visual and~     intraocular pressures on postoperative days (PODs) 1, 3, 7, and 14.~   "
53462|NCT02867176|"~     This is a prospective, randomized, single blind study. Patients enrolled in the study were~     randomly assigned to a ketorolac or a gabapentin group for pain control. Different pain~     scores and variables will be evaluated, along with others side effects variables.~   "
53463|NCT02867163|"~     This is an observational trial to estimate the incidence of deep vein thrombosis (DVT) in~     total knee replacement patients who received an intraoperative dose of tranexamic acid.~   "
53464|NCT02867150|"~     The purpose of this study is to determine whether red light therapy using LED 635nm red light~     for body contouring of the waist, hips and thighs is as effective as red light therapy using~     Laser 635nm red light.~   "
53465|NCT02867137|"~     The PreTBI I study will investigate whether prehospital blood samples drawn already in the~     ambulance can rule-out intracranial lesions in patients suffering head trauma. The study aims~     to improve triage and treatment of patients suffering mild head trauma, who are considered~     low-risk patients. These patients do not always benefit from hospitalization, but are~     nevertheless admitted on precaution, as clinical assesment can be difficult.~      Hypotheses:~        1. A prehospital measurement of serum S100B ≤ 0,10 microgram/L in mild TBI patients rules~          out traumatic intracranial lesion with a sensitivity >97%.~        2. A prehospital measurement of serum GFAP (glial acidic fibrillary protein) in mild TBI~          patients rules out traumatic intracranial lesion with sensitivity >97% and results in~          lower false positive rate than S100B.~        3. Prehospital measurements of both GFAP and S100B results in lower false positive rates~          than in-hospital measurements.~   "
53466|NCT02867124|"~     This proposed five-year study will focus on whether the addition of providing XR-NTX~     treatment at a patients' place of residence will increase adherence and thus efficacy of the~     medication.Following initial screening, informed consent, and medical examination,~     pre-release prisoners at each facility will be block randomized (N=240) within gender to~     either: Condition 1. XR-NTX-OTx (n=120): One injection of XR-NTX in prison, followed by six~     monthly injections post-release in the community at an opioid treatment program; or Condition~     2. XR-NTX+MMTx (n=120): One injection of XR-NTX in prison, followed by six monthly injections~     post-release in the community at the patient's place of residence.~   "
53467|NCT02867111|"~     Infertility is considered a disease by the World Health Organization and it is increasing~     worldwide affecting more than 70 million couples. About 50% of the cases are due to male~     inability to fertilize the oocyte. In the last 40 years, several techniques, known as~     Assisted Reproduction Technology (ART) have been developed to treat infertility, but the~     efficiency is still relatively low (around 30%) whereas the remaining 70% attempts again~     several times, an expensive and emotionally moving treatment. Over 4million of infertility~     treatments are practiced around the world per year and a 50% increment is expected over the~     next 6years. Even though ART allows the birth of babies that would be impossible under~     natural circumstances, it is still necessary to improve the procedures in order to increase~     treatment efficiency. The success of ART depends, to some extent, on sperm quality. Indeed,~     the relevance of spermatozoa quality is notorious even beyond fertilization, extending to~     embryo development and implantation. In this context, it has been developed a new technology~     that allows the selection of those spermatozoa at their best functional state (Sperm~     Selection Assay, SSA; Patent approved for USA and Europe, pending for Japan and Argentina).~     This method is based on the attraction of spermatozoa ready to fertilize the egg, towards a~     physiological attractant molecule. The SSA may be applied to improve diagnosis and~     infertility treatment. The investigators hypothesis states that the use of the SSA will~     improve the number of good-quality embryos which are the ones to be transferred by~     intracytoplasmic sperm injection (ICSI), providing a healthy embryo development. The protocol~     involves three experimental groups where the SSA will be used or not, before performing the~     ICSI: 1)SSA containing the sperm attractant molecule, 2)SSA without the attractant molecule,~     and 3)without SSA. The patient inclusion criteria involve female factors associated to tubal~     obstruction and/or endometriosis and male factors associated to sperm disability. Several~     outcome parameters will be determined, the percentage of fertilization, embryo quality, rate~     of pregnancy and rate of birth. The study will be carried out in the Universitarian Institute~     of Reproductive Medicine (IUMER) which has been recently established in a public hospital~     depending on the National University of Córdoba, offering free high complexity infertility~     treatment to patients without health insurance or economic support~   "
53470|NCT02867072|"~     Appendectomy is the most common surgical procedure performed in emergency surgery. Because of~     lack of consensus about the most appropriate technique, appendectomy is still being performed~     by both open (OA) and laparoscopic (LA) methods. In this retrospective analysis, the~     investigators aimed to compare the laparoscopic approach and the conventional technique in~     the treatment of acute appendicitis.~   "
53471|NCT02867059|"~     This is a single-centre, open-label, study using induced blood stage malaria (IBSM) infection~     to characterize the activity of (+)-SJ000557733 or SJ733 for short, against early Plasmodium~     falciparum blood stage infection. The study will be conducted in two cohorts (n=8 per~     cohort). The anticipated efficacious dose range is expected to be within a range of 125 to~     600 mg. The dose used in the first cohort was determined on the basis of the safety and PK~     data generated in the FIM study (NCT02661373) currently ongoing in United States (US) and~     will be 150 mg. Depending on the pharmacodynamics data (effect of SJ733 on parasitaemia)~     obtained from this first cohort, the dose in Cohort 2 may be adjusted but will not exceed 600~     mg. Based on the PK from all three cohort from the FIM study, the median estimated dose to~     obtain the target SJ733 AUC of 13,000 (ug hr/L) is 370 mg. The dose of cohort 2 (≤600mg) is~     intended to provide further concentration-response information in the human challenge model.~      For Cohort 2 only, a second dose of SJ733 may be administered at peak gametocytaemia to~     assess if SJ733 can reduce gametocytes and subsequent infectivity to mosquitoes (a washout of~     ~15 days post initial SJ733 treatment will be observed). Depending on the data obtained from~     the first two cohorts, there may be a subsequent cohort, with the investigated dose of SJ733~     to be determined by the Sponsor and Principal Investigator (PI) and endorsed by the Safety~     Review Team. Should this third dose be investigated, a substantial amendment including~     preliminary data from the first two cohorts will be submitted to the HREC for approval.~   "
53472|NCT02867046|"~     Lumbosacral transforaminal epidural steroid injection (TFESI) is helpful for the treatment of~     lumbosacral radicular pain, but in case of intravascular injection, infrequently serious~     complication can be developed. Against this backdrop, if there is any difference of frequency~     of intravascular injection incidence during S1 (sacrum 1) TFESI between method using medial~     approach and method using lateral approach in anteroposterior view, the result can be crucial~     factor in selecting the approach. In addition, appropriate volume of injection will be~     checked in each approach.~   "
53473|NCT02867033|"~     The purpose of this study is to constitute the French largest Aggressive fibromatosis cohort.~   "
53474|NCT02867020|"~     Evaluation of the activity, safety and patients reported outcome of ADT plus abiraterone,~     abiraterone plus APALUTAMIDE (a second-generation antiandrogen) or APALUTAMIDE alone in~     hormone naïve locally advanced or metastatic prostate cancer which ADT was indicated.~   "
53475|NCT02867007|"~     The purpose of this study is to characterize the safety, tolerability, and determine the~     maximum tolerated dose (MTD) or the highest protocol-defined dose, in the absence of~     exceeding the MTD, of KHK2455 administered orally in combination with mogamulizumab to~     subjects with locally advanced or metastatic solid tumors.~   "
53476|NCT02866994|"~     This randomized comparative effectiveness trial examines the potential psychosocial and~     physical health-related benefits of sharing personal websites with other women with breast~     cancer, as well as with family and friends (PCO PLUS condition) versus sharing with family~     and friends only (PCO condition) in a sample of women with metastatic breast cancer.~   "
53477|NCT02866981|"~     The purpose of this registry is to determine if select patients with CNS metastatic disease~     can be safely observed rather than treated. The investigators hypothesize that there is a~     subset of patients with small asymptomatic CNS mets that do not require treatment, these~     patients can simply be observed and will not have CNS progression.~   "
53478|NCT02866968|"~     The study will be a pilot interventional case series aiming to treat 30 patients with~     Femtosecond Laser-assisted Pterygium Surgery (FLAPS). All patients included will undergo~     FLAPS in one eye. All procedures will be performed in SNEC by fully qualified surgeons. The~     doctor is informed of the procedure on the day of.~   "
53479|NCT02866955|"~     Despite advances in early detection and treatment strategy, about 25 to 40% of patients~     treated for breast cancer develop metastasis.~      Some patients are in a therapeutic impasse situation. It is therefore necessary to consider~     all possible options. The Estramustine showed encouraging results in the treatment of~     metastatic breast cancer.~      Given the clinical data, the answer rate of Estramustine and its impact on progression free~     survival deserve to be studied in earlier clinical situation.~      This Phase II study evaluated the efficacy of Estramustine in women with breast cancer and~     metastates, already treated with aromatase inhibitors and for whom this treatment has failed.~   "
53480|NCT02866942|"~     A new influenza vaccine, known as LAIV (Live Attenuated Intranasal Vaccine) has recently been~     approved by a number of licensing boards and is given by a spray into the nose. In the United~     Kingdom (UK), the vaccine has been demonstrated to be highly effective against influenza~     infection. Further, despite concerns that LAIV can cause wheezing in children under age 2~     years, the previous SNIFFLE studies have demonstrated it to be safe in children over 2 years~     with mild-moderate asthma.~      The objective of this multicentre study is to further assess the safety of intranasal LAIV in~     children with asthma and recurrent wheeze, including those with severe symptoms.~   "
53481|NCT02866929|"~     Numerous treatment protocols geared towards accelerating orthodontic treatment have emerged~     in the past few years as an appealing alternative for patients and practitioners. In the~     context of a thin biotype, these approaches pose a burden that could precipitate periodontal~     detrimental changes. Therefore, case selection and the implementation of periodontal biotype~     enhancing strategies become a relevant consideration to ensure long-term successful treatment~     outcomes. This study focuses on the biological and clinical value of the use of a porcine~     naturally cross-linked collagen matrix known as Mucograft®. Within the scope of Surgically~     Accelerated Orthodontic Treatment (SAOT) the structural and material features of Mucograft®~     provide: 1) A protective effect to the thin biotype upon rapid orthodontic~     protusive/proinclination movements and 2) Mucograft® enhances the therapeutic window effect~     that supports an increase on tooth movement rate. The designs of this randomized controlled~     clinical trial includes a cohort of 40 subjects distributed on the following groups I) Ortho~     tx, II) Ortho tx + Decortication, III) Ortho tx + Decortication + Mucograft®, and IV) Ortho~     tx + Mucograft®. Comparing clinical, tomographic and digital impression derived measurements~     will capture the clinical phenotype; while the biologic phenotype will be derived from~     evaluating crevicular fluid levels of tooth movement mediators such as Interleukin 1-β and~     Interleukin-1RA. The significance and innovative value of this proposal stems from the use of~     Mucograft® as an ideal collagen-based biotype enhancer when performed along with the~     corticotomy. This approach could prove to be effective to further increase the therapeutic~     window that allows accelerating orthodontic treatment and, at the same time, could decrease~     the recession risk in movements of proclination of antero-inferior incisors. Besides, the use~     of a collagen scaffold alone could potentially trigger a comparable orthodontic acceleratory~     outcome that could be evaluated as an alternative to decortication.~   "
53482|NCT02866916|"~     This is a single site, open-label, non-randomized, dose escalation phase I study designed to~     evaluate the safety, the tolerability and the Recommended Phase II Dose (RP2D) of SXL01, a~     synthetic small interfering ribonucleic acid (RNA) targeting the androgen receptor messenger~     RNA (mRNA), in patients with metastatic castration-resistant prostate cancer.~      A standard method 3+3 will be used for dose escalation. A maximum of 30 patients will~     complete the dose-escalation phase of the study; 12 additional patients will be included at~     the RP2D in the expansion phase.~   "
53483|NCT02866903|"~     Peritoneal carcinosis (PC) corresponds to a locoregional extension into the peritoneum of~     rare primary peritoneal cancers, or more frequently distant extension of digestive cancers~     (colorectal or gastric) or gynecological (ovarian, fallopian tube, or endometrial). PC can be~     considered as a distinct oncological entity as its genesis, natural history, and response to~     systematic treatments differ to those of other metastases. The development of PC, observed in~     25-35% of colorectal cancers, is generally considered as a unfavorable event in the course of~     the disease. The prognosis is defined by the possibility of complete resection, possibly~     after neoadjuvant treatment. The benefit provided by the combination of cytoreductive surgery~     and heated intraperitoneal chemotherapy (HIPEC) with respect to systemic chemotherapy in~     patients with PC of colorectal origin has been demonstrated based on overall survival in~     several randomized trials, among which one evaluated oxaliplatin. The evaluation of the~     clinical benefit-risk related to the repeated administration of non-hyperthermic~     intraperitoneal chemotherapy, as has been validated in ovarian cancer, in patients with PC of~     colorectal origin is already being investigated by several international teams.~      The FOLFOXIRI + bevacizumab every 2 weeks is a modern therapeutic option in patients with~     this disease. The intraperitoneal rather than intravenous (IV) administration of oxaliplatin,~     in this combination, could increase the response of peritoneal lesions known to be relatively~     insensitive to IV chemotherapy.~   "
53484|NCT02866890|"~     The Laryngeal Tube Suction Disposable( LTS-D) has recently undergone considerable structural~     changes in design. As these changes may influence the performance of the LTS-D relative to~     the old LTS-D version the investigator decided to check the new LTS-D in the pediatric~     version The investigator hypothesized that the LTS-D perform clinically well during general~     anesthesia with controlled ventilation.~   "
53485|NCT02866877|"~     This study evaluates the pharmacokinetic profile of levetiracetam in critically ill patients~     who have suffered a subarachnoid hemorrhage. The patients will be evaluated for development~     of augmented renal clearance and the effects and duration of effects this may have on~     levetiracetam clearance.~   "
53486|NCT02866864|"~     The investigators will evaluate sensitization to animal allergens and allergic symptom during~     contacting animal allergens in Korean veterinary researchers who attend their annual~     conference.~      The investigators will compare sensitization to animal allergen and other clinical and~     occupational factors between subjects who suffer from allergic symptom during contacting~     animal and those who do not.~   "
53487|NCT02866851|"~     Patients should receive a chemotherapy regimen with an overall risk of febrile neutropenia ≥~     20%. The use of the web-application their will be proposed .~      They will be informed of the risk of neutropenia, fever and bleeding which may occur beyond~     the fifth day of each chemotherapy cycle (to eliminate fevers related to treatment).~      The temperature measurement is performed at home by an infrared forehead thermometer provided~     as part of the study, in a systematic manner once daily at the same time of day and in case~     of unexplained fatigue or chills.~      Before any fever reported to the physician via the web-application (alert), a questionnaire~     will be completed by the patient to the search for gravity criteria to assess his condition~     at home. The patient will be hospitalized immediately if it shows signs of severity in order~     to document the infection and provide intravenous antibiotics adapted to the clinical~     condition; in the absence of these signs, the patient will make a count to the nearest lab~     and will receive oral antibiotics if indicated. The subsequent strategy will be defined by~     the web-application algorithm to optimize the care of patients.~      The ability to use a web-application could allow early detection of complications of~     post-chemotherapy haematological toxicity and offer a taking over guided by a decision-making~     algorithm managed by the physician.~      The aim is to favour the taking over at home.~   "
53488|NCT02866838|"~     Novel, non-vitamin K antagonist oral anticoagulants (NOAC) target selected players in the~     coagulation cascade as the direct thrombin inhibitor dabigatran and the factor Xa-inhibitors~     apixaban and rivaroxaban. Intracerebral hemorrhage (ICH) is the most feared complication of~     NOAC treatment (NOAC-ICH).~      Outcome of NOAC-ICH can be devastating and is a major cause of death and disability. There is~     no proven treatment for NOAC-ICH. Hematoma expansion (HE) is associated with unfavorable~     outcome. Tranexamic acid (TA) is an anti-fibrinolytic drug that is used in a number of~     bleeding conditions other than ICH.~   "
53489|NCT02866825|"~     The trial enrolls patients undergoing a complex cardiac surgery. The primary goal of the~     trial is to evaluate the pharmacodynamic dose response relationship of the monoclonal~     antibody IFX-1 in these patients. In addition, this trial further aims to characterize the~     safety and the pharmacokinetics of IFX-1 as well as to collect first data on its efficacy on~     clinical surrogate endpoints.~   "
53497|NCT02866721|"~     This study is being done to test if it is safe to give stem cells to adult patients with~     Cystic Fibrosis (CF). The kind of stem cells we are studying are called allogeneic human~     mesenchymal stem cells or MSCs. MSCs are cells in the body that can grow into different types~     of cells and respond to various environmental situations. Allogeneic means the cells come~     from another person (a donor).~      This study is only looking at whether or not it is safe to give the stem cells to adults with~     CF and how the infusion is tolerated. In the future, other studies may be done to see if stem~     cells can be a new therapeutic treatment for CF.~      Stem cells, like other medical products that are intended to treat, cure or prevent disease,~     generally require approval from the U.S. Food and Drug Administration (FDA) before they can~     be marketed. The FDA has not approved any stem cell-based products for usual medical care,~     other than some specific blood forming stem cells for certain indications.~   "
53520|NCT02866422|"~     To support the discovery of new means for revealing the presence of Obsessive Compulsive~     Disorder (OCD), facilitating detection through new technology-based metrics, and attempt to~     automate existing diagnostic procedures allowing for more efficient diagnostic methods that~     would broaden clinical scope and outreach.~   "
53490|NCT02866812|"~     During the last decade, the embolization has become the treatment of choice for ruptured~     intracranial aneurysms, to improve the neurological outcome of patients. At the same time,~     for his safety, she also became the technique allowing prophylactic treatment of unruptured~     intracranial aneurysms discovered incidentally during imaging exams.~      Regarding patients with ruptured intracranial aneurysms, patients who survive often have a~     reduced quality of life while one in two has a good neurological outcome after embolization.~     Depression, anxiety and fatigue, whose the psycho-social impact is important, are often~     cited. This description has often been done without considering the realized type of~     treatment (surgery or embolization) and mostly of neurological and functional status of the~     patient remotely (disability or not in daily activities).~      Regarding patients with unruptured intracranial aneurysms, they are mostly asymptomatic and~     embolization is programmed. They would present an cognitive impairment in one case in five at~     1 month of treatment.~      If depression, fatigue and difficult return to working life are logically found in patients~     with severe sequelae (disability in daily activities) of their ruptured intracranial~     aneurysms, the question arises for patients with a ruptured intracranial aneurysms with a~     favorable evolution and for asymptomatic patients with unruptured intracranial aneurysms.~      A precise status of these populations is necessary, especially as the discovery and treatment~     of their intracranial aneurysms is often early (between 40 and 60 years) and that their good~     neurological status should allow a priori to return easily at the active life.~   "
53491|NCT02866799|"~     This study assesses the effectiveness of a complex intervention in young-old patients with~     multimorbidity and polypharmacy aimed at improving physician drug prescription in primary~     care, measured by means of the Medication Appropriateness Index (MAI)-score at six 6 (T1) and~     12 (T2) months from baseline compared to usual care.~   "
53492|NCT02866786|"~     Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorder in women of~     reproductive age and is a leading cause of infertility due to anovulation. Oral contraceptive~     pills (OCPs) are considered as first line medical therapy to regularize menses in woman with~     PCOS. However they may worsen the metabolic profile of patients by elevating insulin~     resistance which is already deranged in PCOS. As there is higher prevalence of insulin~     resistance in Indian women with PCOS, insulin sensitisers like metformin may be more~     beneficial. Hence this study is undertaken to compare the combined effect of metformin and~     OCPs on the clinical, hormonal, metabolic and ovarian ultrasonographic characteristics in~     patients with PCOS and to evaluate whether this combination of drugs is more advantageous~     than OCPs or metformin alone in improving the clinical and metabolic profile.~   "
53493|NCT02866773|"~     In Hong Kong, nearly 40% of adults were overweight or obese, and about 60% of total~     registered deaths were due to four major preventable non-communicable diseases. Many~     residents are lack of attention to personal healthy lifestyle and family holistic health.~     This project focuses particularly on the promotion of healthy diet and physical activities~     enhancement in families through the well-established community network of the Hong Kong~     Island Women Association (HKIWA). This project includes three major components:~     Train-the-trainer and -ambassador workshop, community-based family interventions, and public~     education events. It is expected that knowledge and skills of the community leaders and~     ambassadors are strengthened through the 'Train-the-trainer and -ambassador' (TTTA)~     workshops. Furthermore, they are expected to help the implementation of community-based~     family interventions and public education events on the personal and family holistic health~     of the community participants.~   "
53494|NCT02866760|"~     This study aims at understanding the needs and concerns of Chinese current smoking patients,~     including their risk perceptions, and the behavior, attitudes, and experiences related to~     smoking and smoking cessation. Specifically, how smokers overcome withdrawal symptoms and~     cigarette cravings, as a result of banning on smoking in hospitals, will be explored. In~     addition, whether smokers will stop, resume or continue smoking after hospitalization will be~     investigated.~   "
53495|NCT02866747|"~     This study is a phase I/II, national, multicenter, open-label study starting with a Phase I~     part followed by a Phase II part.~      The phase I part of the study aims to evaluate the safety of the association of~     hypofractionated stereotactic radiation therapy (hFSRT) and the anti-PD-L1 Durvalumab~     immunotherapy in patients with recurrent glioblastoma. A maximum number of 12 patients will~     be enrolled in this phase I part.~      Once the recommended combination schema will be declared, patients will be enrolled in the~     Phase II part of the study in order to evaluate the efficacy (local control rate) of the~     combined treatment in recurrent glioblastoma. In this Phase II part, patients will be~     assigned by randomization to one of the two following arms:~        -  Arm A (control arm): Radiation therapy alone (17 patients)~        -  Arm B (Experimental arm): Combined treatment with Anti-PD-L1 Durvalumab (33 patients)~   "
53496|NCT02866734|"~     Introduction: Diabetic mellitus (DM) is a prevalent disease in Hong Kong (HK) and diabetic~     retinopathy (DR) is one of the most common complications of DM. Screening for DR is a~     cost-effective method to identify patients who are at risk of vision loss so that timely~     treatment can be provided to patients. In Hong Kong, the Hospital Authority has recently set~     up screening services (RAMP) in the government outpatient clinics and all DM patients~     attending these clinics will be screened at least once every two years and some every six~     months, according to their individual risks. However, those diabetic patients who attend the~     private sector for their primary care may not have access to this service.~      Aim: This study from the University of Hong Kong aims to determine the characteristics of a~     sustainable approach to setting up an effective and quality-controlled screening service for~     DR in the private primary care sector of Hong Kong and to estimate the potential benefit to~     be gained in terms of impact on avoidable vision loss, costs of care and potential for~     further development of this model in chronic disease care.~      Methods:A screening centre is being set up and a randomised study carried out in which~     screening will be offered at three different fee levels to subjects recruited by their~     general practitioner (GP). The following data will be collected (a) willingness to attend~     screening at the different fee levels (b) screening findings in terms of DR and other eye~     diseases (c) risk factors and other characteristics of those screened and unscreened. The~     information will allow us to estimate the level of fee which best combines effectiveness with~     sustainability in the longer term.~   "
58848|NCT02796599|"~     The purpose of this study is to determine wether the interface (facial or nasal mask)~     influences performance in patients with chronic obstructive pulmonary disease exercising with~     non-invasive ventilation.~   "
53498|NCT02866708|"~     This is a pilot study to evaluate the treatment effect of INP on wound healing and tissue~     perfusion for a larger randomized controlled trial (RCT). This randomized cross-over pilot~     study will look at the effects of intermittent negative pressure (INP) therapy wound healing~     and the peripheral macro- and microcirculation in spinal cord injured patients with chronic~     leg and foot ulcers (6 weeks or more at inclusion). The project is designed as a randomized~     clinical trial with single-subject multiple baseline design. We will perform convenience~     sampling of spinal cord injured patients with leg and foot ulcers, with the last recruitment~     by the end of december 2016.To ensure equal distribution of participants in each study arm,~     we will perform block randomization. A statistician will randomized patients to either~     intervention arm or control arm before start of the study: At baseline, each participants~     will be randomized into either A) 8 weeks without intervention OR B) 8 weeks with start INP~     therapy 2 hours per day divided into 2-3 timed sections. After the 8 weeks, participants in~     the the control group (A) will be re-examined, and start 8-week INP therapy. Also the~     intervention (INP) will be subjected to the same lower limb in each individual throughout the~     study period. The other leg will act as a intra-individual control.~      At baseline (week 0), and during the course of the study (every 4th week), the participants'~     wounds will be measured by a wound nurse. Baseline (before start of INP therapy) and after~     intervention the following measures will be performed: Demographic data (weight, height,~     ABI), Segmental pulse-volume-recording, Segmental skin perfusion pressure with a laser~     Doppler sensor and a pressure cuff to evaluate reactive hyperemia (Sensilase, Väsamed) and~     health surveys (SF-36/EQ-5D-5L and customized wound questionnaire) or similar will be~     examined at baseline and and the end of the study period. Otivio AS has supplied the FlowOx~     devices and provided the necessary training to perform this project. Outcome variables~     assessed before and after the study period will be: wound healing (primary endpoint), quality~     of life (secondary endpoint), skin perfusion pressure (secondary endpoint), ankle-brachial~     pressure (secondary endpoint) and segmental pulse-volume recording (secondary endpoint). The~     aim of this project is to prospectively examine and elucidate the effect of intermittent~     negative pressure therapy applied to a limited part of the lower limb on clinically relevant~     measures related to wound healing and peripheral macro- and microcirculation in patients with~     spinal cord injury.~      The hypotheses of the study are:~        -  Application of INP in patients with spinal cord injury, by the use of the FlowOx™~          device, will improve wound healing in the foot compared to before treatment (baseline)~          and compared to standard wound care alone.~        -  Application of INP in patients with spinal cord injury, by the use of the FlowOx™~          device, will improve macro- and microcirculation in the foot compared to before~          treatment (baseline) and compared to standard wound care alone in patients with spinal~          cord injury.~        -  Application of INP in patients with spinal cord injury, by the use of the FlowOx™~          device, will improve macro- and microcirculation in the intervention foot compared to~          the control foot and compared to standard wound care alone in patients with spinal cord~          injury.~   "
53499|NCT02866695|"~     This is a single arm, open-label interventional study of ingenol mebutate 0.015% in solid~     organ transplant recipients. The investigators plan to treat 20 subjects, 10 kidney~     transplant recipients and 10 lung transplant recipients. The investigators have selected~     these two populations as the represent the spectrum of solid organ transplantation: kidney~     transplant recipients are the largest transplant population, but have lower levels of~     immunosuppression and skin cancer risk. Lung transplant recipients have the highest burden of~     skin cancer and actinic keratoses.~   "
53500|NCT02866682|"~     As the patents for brand-name immunosuppressive medications expire, there is increasing~     interest in using generic immunosuppressive drugs. However, despite pharmacokinetic studies~     showing bioequivalence, questions remain regarding the clinical impact of use of generic~     immunosuppression.~      The most important immunosuppressive agent in the modern transplant era is arguably~     tacrolimus, a calcineurin-inhibitor with a narrow therapeutic index. This study seeks to~     answer the question regarding the clinical impact of generic tacrolimus use as measured~     primarily by acute rejection, loss of graft function, and patient death through a randomized~     trial of 4 parallel groups: Brand tacrolimus only, brand tacrolimus for 6 months than switch~     to Generic A, Generic A only, or Generic A for 6 months than switch to any other generic~     tacrolimus. Given that kidney, liver, and heart transplantation are the most commonly~     performed transplants with well-defined measures of rejection and graft failure, these organs~     will be studied in a two-center study designed to accrue the target number of transplant~     recipients within the three-year study period.~   "
53501|NCT02866669|"~     The central objective of this proposal is to rigorously compare two strategies designed to~     improve BP control in primary care practices serving rural Southeastern African Americans~     with low socioeconomic status (SES) living in the Black Belt.~      The Agency for Healthcare Research and Quality (AHRQ) Disparities Report identifies~     individuals with rural residence, minority ethnicity, and low SES as being at high risk for~     poor health outcomes. The Black Belt region stretches from eastern Texas in an arc to~     Maryland and includes residents with all 3 of these characteristics - the proverbial triple~     threat. This traditionally agricultural region is characterized by steep poverty, low~     educational attainment, scarce resources, and mostly African American residents. The Black~     Belt is in the heart of the Stroke Belt, a geographic area long recognized to have the~     highest cardiovascular disease (CVD) mortality in the US. The AHRQ Disparities Report also~     cites that the Southeast has lower quality of care than the rest of the US, thus effective~     strategies to optimize CVD prevention in general and hypertension (HTN) control specifically~     are urgently needed here.~      In year 1 (AIM 1) we're engaging community members (community members who have experience~     being community peer advisors or have high blood pressure) to develop the study interventions~     and protocols. In years 2-5, the investigators will test these interventions.~   "
53502|NCT02866656|"~     In the present study, by evaluating the efficacy and safety of low intensity ultrasonic on~     ASO, to explore the noninvasive auxiliary treatment of ASO. 90 patients were randomly divided~     into 2 groups: A)control group, patients were given Conventional conservative treatment;~     B）treatment group, patients were given Conventional conservative treatment and low intensity~     ultrasonic treatment ; Treatments last for 4 weeks, three times a week, stimulation was given~     8 minutes every time, location of treatment were lower limb ischemia area and its surrounding~     tissues; outcome indicators were recorded Before and 4 weeks after the trial, The Walking~     Impairment Questionnaire (WIQ), ankle brachial ratio, the farthest distance Walking,~     percutaneous tissue oxygen tension, tissue oxygenation index recovery time, local skin~     temperature, ultrasonic blood vessels, and muscle enzymes, hepatic and kidney function.~   "
53503|NCT02866643|"~     A barrier to initiating progestin contraceptives in the early postpartum period is the~     concern of interference with breastfeeding, specifically lactogenesis. In this trial, the~     investigators aim to add to safety data on the effects of immediate insertion of the~     contraceptive implant on breastfeeding. The investigators seek to examine the time to~     lactogenesis with immediate post-delivery insertion in delivery room versus insertion of a~     contraceptive implant in the postpartum ward prior to medical discharge. For this study, 82~     consenting women will be randomized to immediate implant insertion (0-2 hours following~     delivery) in the delivery room or insertion of the implant following delivery in postpartum~     room and prior to medical discharge (24-48 hours following delivery).~   "
53519|NCT02866435|"~     The purpose of this study is to investigate how the brain responds to low blood glucose in~     non-diabetic individuals. The ultimate goal is to understand the brain substrates of~     hypoglycemia unawareness, a condition that can occur in patients with type1 diabetes~     undergoing insulin treatment.In the present study, the investigators focus on differences~     between two groups of non-diabetic subjects: one group who experienced two episodes of~     hypoglycemia the day prior to the study (and supposedly developed some level of unawareness~     to hypoglycemia), and one group who did not. In this study, a 3 tesla MRI scanner is used to~     acquire brain images. The imaging system is identical to the ones used in hospitals.~   "
53504|NCT02866630|"~     In the last few years, anaesthetics gas such as isoflurane, desflurane and sevoflurane used~     in heart surgery have shown some benefits to reduce the risk of heart muscle damage than~     total intravenous anesthetics. A study by the investigators suggested that isoflurane needs a~     longer duration to achieve equilibrium between coronary sinus and radial artery, indicating~     that isoflurane in coronary sinus does not accurately reflect its level in the heart muscle.~     Different agents have unique characteristics with different equilibration rate. However, the~     levels of sevoflurane and desflurane in coronary sinus and radial artery have not been~     measured. In addition, lactate is believed to be a very useful indicator to predict the~     outcome of recovery phase after any surgery. This study aims to measure the level of~     sevoflurane or desflurane in blood circulation. It will also assess whether sevoflurane or~     desflurane concentration in the blood is correlated to the its oxygenator exhaust level and~     affected by temperature, haematocrit level and gas flow rate during heart-lung machine. It~     also aims to examine the association of lactate and the outcomes of cardiac patient in~     intensive care unit after cardiac surgery.~   "
53505|NCT02866617|"~     In dentistry, 3D printing technology is gaining interest. One of the potential application is~     to construct appliances on 3D reconstructed study models.~      The purpose of this study is to compare vacuum formed thermoplastic orthodontic retainers~     (VFR) constructed on conventional orthodontic study models and reconstructed 3D study models~     by assessing the oral health-related quality of life (OHRQoL) instrument, Little's~     Irregularity Index (LII) and compliance.~   "
53506|NCT02866604|"~     The main objective of this study is to compare the clinical outcomes of TBI patients~     receiving only Sterofundin or 0.9% saline as main fluid therapy.~   "
53507|NCT02866591|"~     Mammography is used for screening, diagnosis, therapeutic evaluation and monitoring of local~     cancer breast.~      It is sometimes poorly tolerated by some patients who complain of an uncomfortable~     examination or pain.~      Breast compression by the manipulator aims to reduce the thickness of the breast during~     mammography; This act is an important factor of pain or discomfort felt by the patient. But,~     it is also an image quality factor.~      This study aimed to compare self-breast compression by the patient to the compression~     standard technique carried out by the manipulator.~   "
53508|NCT02866578|"~     Cardiac surgery with cardiopulmonary bypass (CPB) frequently induces post-operative~     respiratory dysfunction. The post-operative pulmonary complications (PPCs) significantly~     increase the peri-operative morbidity and require invasive treatments during longer and more~     expensive ICU stays. A specific pathophysiology involving general anesthesia and CPB-related~     factors (inflammation, pulmonary ischemia) has been clearly demonstrated and pulmonary~     atelectasis seems to play a central role in the occurence of these PPCs. The open lung~     approach is a ventilation strategy that aims to open the lung and keep it open using~     different ventilatory settings. The efficacy of that strategy is not demonstrated in the~     global surgical population. However, its application in the perioperative care of cardiac~     surgery patients could be of great interest by counteracting the development of atelectasis.~      The purpose of this multicentre, double blinded, randomized controlled study is to evaluate~     the influence of a perioperative multimodal protective ventilation strategy based on the~     open lung approach on postoperative outcomes during the first 7 days following cardiac~     surgery. Participating centres will include 500 adult patients undergoing scheduled on-pump~     cardiac surgery. The open lung approach will combine recruitment maneuvers (RM), positive end~     expiratory pressure (PEEP) at 8 cmH2O from intubation to detubation and continuation of~     ultraprotective ventilation during CPB. It will be compared to a conventional approach~     without RM, with PEEP at 2 cmH2O and discontinuation of ventilation during CPB. The primary~     endpoint is any post-operative pulmonary complication. The secondary endpoints are any~     post-operative extra-pulmonary complications and the number of ICU-free days to day 7.~   "
53509|NCT02866565|"~     Diabetic foot ulcer (DFU) is a major complication and the leading cause of hospitalization~     among people with diabetes mellitus. It occurs in 15% of all patients with diabetes and~     precedes 84% of all lower leg amputations. Despite many therapeutic advances over the past~     decades, including dressings (hydrocolloids, alginate, skin substitutes) and growth factors,~     healing rates of DFU remain low.~      Mechanisms of faulty wound healing in diabetic patients are complex, related to both~     intrinsic and extrinsic factors. The main reasons for impaired healing appears to be:~     1/exhaustion of local cell populations that promote wound healing; 2/excessive production of~     matrix metalloproteases (MMPs) coupled with reduced expression of the tissue inhibitors of~     MMPs; 3/impaired neovascularisation coupled with reduced numbers of endothelial progenitor~     cells and impairment of their functioning. These imbalances may result in excessive~     degradation of extracellular matrix components, as well as an inappropriate local~     inflammatory response .~      Adipose-derived stroma vascular fraction provides a rich and easily accessible source of~     autologous cells for regenerative medicine applications. Il contains multipotent stem cells~     and progenitors called adipose-derived regenerative cells (ADRCs) able to stimulate wound~     healing. There are attracted to the wound site where they supplement the wound bed with~     similar cell types, secrete numerous growth factors and cytokines, increase macrophage~     recruitment, enhance granulation tissue, and improve vascularisation . The reparative~     capabilities coupled with good safety of ADRCs have been illustrated in a study for treating~     severe and irreversible radiation-induced lesions, and in a study for treating sclerodactyly~     in patients with diffuse scleroderma. Numerous case reports showing healing of refractory~     wounds following treatment with autologous ADRCs have also been reported.~      Based on these previous reports, the present study aims to assess the efficacy and tolerance~     of injection of ADRCs for the local treatment of neuropathic or neuro-ischemic DFU.~   "
53516|NCT02866474|"~     Malnutrition particularly affects people who delegate the preparation of their meals with 46%~     of persons living at home and using a meals-on-wheels service, or those in old people's homes~     (Etablissement d'Hebergement pour Personnes Agees Dependantes - EHPAD) at risk of~     malnutrition, compared with 16% in persons who have help, but not for their meals, and 8% in~     independent persons (Aupalesens Survey). This proportion, which is particularly high, is~     essentially due to the absence or insufficient level of individual monitoring of the~     nutritional status of these dependent populations despite the different recommendations.~     EHPAD (old people's homes) are invited to respect meal rhythms, to adapt the nutritional and~     gustatory qualities of the food, to propose a pleasant environment (Survey CLCV 2012: data~     collection in 2012); in parallel, few professionals are really trained in the needs of the~     elderly. In meals-on-wheels services, apart from the distribution of meals, no nutritional~     follow-up is proposed (Guide 2012).~      Symmetrically, the constant search to control costs in western healthcare systems has led~     managers to systematically reduce care costs, in particular those that are not directly~     related to medico-pharmaceutical or care personnel expenditure in the strictest sense. In the~     collective catering services, there is, for example, a systematic effort to reduce daily~     costs/materials, without measuring the global cost related to the efficacy of care.~      The present work is part of the RENESSENS project: these studies will be conducted in two~     elderly populations, one living at home and receiving meals on wheels daily and a regular~     visit of a dietician, who will propose individual nutritional follow-up and the second living~     in an old people's home (EHPAD) that will benefit from the improved management of its~     catering service (good culinary practices, including specific training for personnel and~     meals adapted to the needs of residents). The principal aim of these two studies will be~     common and will be to evaluate the efficacy of this specific type of management of meals and~     nutrition compared with a reference meals-on-wheels service and a reference EHPAD.~   "
69726|NCT02654301|"~     The present study determined the effect of Xylose consumption on postprandial hyperglycemia~     in normal (n=25) and hyperglycemic subjects (n=50).~   "
53510|NCT02866552|"~     Systemic sclerosis (SSc) is an auto-immune orphan disease mainly characterized by an~     alteration of the microvascular network, and by cutaneous and visceral fibrosis. Hands are~     frequently affected, as a consequence of ischemic phenomena and cutaneous fibrosis. As a~     result, patients suffer from everyday disability, with consequences on their occupational~     activities and social contact, sometimes severely altering their quality of life. To date, no~     anti-fibrosis treatment has proven effective; existing vasodilation treatments are~     unfortunately not very effective, and are associated with adverse effects or restrictions. It~     is consequently of utmost importance that an effective treatment for sclerodermic hands be~     developed. The injection of adipose autologous tissue is a common practice in plastic~     surgery, and has been known for over a century. Adipose tissue, originally used to increase~     volume, is also characterized by trophic properties associated to stromal vascular fraction~     (SVF), which contain multipotent stem cells, capable of tissue repair. Interestingly, some~     SVF cells can be angiogenic and anti-inflammatory, which could improve damage seen with SSc.~     The injection of SVF into the fingers would also make it possible to control the production~     of the extracellular matrix and to improve the balance between fibrosis and fibrolysis,~     resulting in an improvement of cutaneous sclerosis~      The main purpose is to evaluate the efficacy of SVF injections in the fingers of patients~     suffering from SSc on the Cochin hand functional scale evaluated at 12 months, in comparison~     to the control group.~   "
53511|NCT02866539|"~     The aim of the study is to control blood sugar with Sugar Balance capsules which is the~     leaves of three herbs: ivy ground (Coccinia indica)-200mg, bougainvillia (Bougainvillea~     spectabilis)-30mg, Madagascar periwinkle (Catharanthus rosea)-20mg.~   "
53512|NCT02866526|"~     Severe haemophilia is a rare disease characterized by spontaneous bleedings from early~     childhood, which may lead to various complications especially in joints. Due to advances in~     medical care and more specifically in the development of prophylactic strategies by the~     application of clotting factor concentrates, life expectancy of persons with severe~     haemophilia has significantly increased over the last decades. This progress requires a~     long-term follow-up, including into adulthood. The adherence to a regular clinical follow-up~     and to a prophylactic treatment then depends on how successful patients' transition from~     childhood to adulthood has been as this process involves a transfer of responsibility from~     parents to patients concerning the management of their health. Beyond the issue of patients'~     adherence, a suboptimal transition may also impair quality of life and the entry into~     adulthood, especially at the social, emotional and professional levels. Only a few studies~     have been conducted to identify the specific needs and difficulties young persons with severe~     haemophilia experience during their transition from childhood to adulthood, and none of these~     studies has been carried out in France where the features of the health care system are very~     specific.~      Therefore, this study aims to address the issue of transition into adulthood among young~     persons with severe haemophilia in France. This study will focus not only on the facilitators~     and barriers of the access to health care but also, from a more global perspective, on all~     the specific concerns and difficulties they may experience as they grow into adulthood which~     may impair their long-term health related quality of life as well as their personal~     empowerment. This study will also allow to identify some of the socio- cognitive, emotional,~     and familial determinants of a good transition into adulthood.~   "
53513|NCT02866513|"~     Mechanical ventilation can induce pulmonary lesions called ventilator induced lung injury~     (VILI). High levels of Transpulmonary pressure is one of the most important mechanism of VILI~     during the use of mechanical ventilation. The use of bilevel pressure ventilator modes like~     APRV could generate high levels of transpulmonary pressure.~      The aim of this study is to evaluate the variations of transpulmonary pressure during the use~     of APRV by clinicians~   "
53514|NCT02866500|"~     Context: the oral cancer is the 5th cancer in order of frequency for human in France. It is~     the country where the mortality by oral cancer is the most raised in Europe. The most~     frequent location concerns the oral cavity prevalency of which is one of higher in the world.~     The main risk factors are the tobacco and the alcohol.~      The oral cancer is treated in the great majority of the cases by radiotherapy which is going~     to pull xerostomy, responsible for the degradation of the oral state. Furthermore, it will~     increase the risk of appearance of osteoradionecrosis (ORN) when the patient is carrier of~     buccal lesions and\or when he will have to undergo surgical acts. Consequently, the initial~     oral state of the patients is to be estimated so as to eliminate any source of the infection.~     An unfavourable initial state will increase the risk of degradation of this one and~     appearance of ORN. However, at present few epidemiological data are available concerning the~     oral state of the patients presenting an oral cancer.~      Objective: the main objective of this study is to describe, before radiotherapy, the oral~     state of the patients presenting an oral cancer and to follow the evolution of this oral~     state for three years and to register the patients quality of life. The secondary objectives~     are to describe the distribution of risk factors of the degradation of the oral state (oral~     hygiene, food habits, xerostomy, consumption of tobacco and alcohol) in this population and~     to register the impact of the dental restorations on the radiological assessment.~      Methods: this prospective epidemiological study of observation will be realized in the~     service of odontology of the Timone hospital (Marseille, France) in association with the~     services of ORL and maxillofacial surgery of Timone as well as the services of radiotherapy~     and medical oncology of Timone and Paoli Calmettes institute (IPC). All the toothed patients~     affected by an oral cancer untreated will be included, or treated surgically only, of more~     than 18 years old and for whom an initial dental assessment will be realized. The main~     assessment criteria will be the CAD index and the parodontal state.~      Expected results and perspectives: This study will allow to have epidemiological data~     concerning patients' oral state affected by an oral cancer before and after radiotherapy. It~     will allow to set up a consensus of good practice.~   "
53515|NCT02866487|"~     The pattern of lower airway inflammation in asthma is heterogeneous, but in many patients,~     the polymorphonuclear neutrophil (PMN) is the predominant granulocyte infiltrating the~     airspaces. Although it is known to have an important function in innate immune defense, the~     role of the PMN in asthma has not been well elucidated. In work in progress, the~     investigators have identified the receptor for IL-5 on the surface of bronchoalveolar lavage~     (BAL) PMNs in a subset of children with severe, treatment-resistant asthma, a characteristic~     that is not found in peripheral blood neutrophils. While the function of this IL-5 receptor~     has yet to be determined, preliminary evidence strongly supports a mechanism linking~     neutrophilic with type 2 inflammation in the lower airways of children with asthma, a~     discovery that has exciting potential to modify the treatment of asthma.~      The primary objective of this observational cross-sectional study is to test the overall~     hypothesis that therapeutic intervention directed against the IL-5R on lung PMNs will~     decrease inflammation and improve clinical outcomes in patients with poorly controlled~     asthma. The secondary study objective is to demonstrate that IL-5R expression on~     lung-infiltrating PMNs is functional, will activate known IL-5R-induced signaling pathways,~     and will lead to enhanced PMN pro-inflammatory activity including increased PMN recruitment,~     prolonged survival, degranulation, and release of reactive oxygen species.~   "
53517|NCT02866461|"~     This study is designed to study brain mechanisms associated with symptoms and severity of~     Fibromyalgia. This will be accomplished by relating results from PET scans to self-reported~     and objective measures of disease severity.~   "
53518|NCT02866448|"~     The purpose of this study is to investigate the effect of acute isoquercetin supplementation,~     aspirin, and isoquercetin/aspirin combination on platelet aggregation, blood pressure and~     vasculat stiffness (eg digital volume pulse), as well as investigating the plasma~     accumulation and urine excretion profiles of quercetin.~   "
54001|NCT02860117|"~     The purpose of this study is to evaluate the efficacy of ketamine in continuous infusion in~     the control of pain intensity, the impact on the consumption of opioids and observe the side~     effect profile in patients suffering from great extent of burns.~   "
53522|NCT02866396|"~     Spinal surgery is associated with intense pain and associated to a history of preoperative~     chronic pain. Pregabalin is licensed to treat chronic neuropathic pain, particularly when~     high dose of opioid are required. Preoperative pain is associated with high postoperative~     pain scores and opioid requirement promoting persistent hyperalgesic state. The investigators~     will evaluate the postoperative opioid consumption and pain scores in patients scheduled for~     lumbar surgery and taking pregabalin since more than 15 days and compare with preoperative~     pregabalin-free patient that will receive pregabalin only during surgery.~   "
53523|NCT02866383|"~     This is a prospective, randomized, open-label phase 2 study in patients with metastatic PC~     refractory or intolerant to at least one line of prior systemic chemotherapy with gemcitabine~     or platinum-containing regimens to determine the efficacy and safety of nivolumab or~     nivolumab plus ipilimumab administered concurrently with high dose RT. Patients with~     metastatic PC who are feasible candidates for radiation and biopsy of primary and/or~     metastatic lesions will be included.~   "
53524|NCT02866370|"~     The trial will recruit up to 120 patients; 90 with ovarian clear cell carcinoma and up to 30~     with endometrial clear cell carcinoma. Patients will be randomised between chemotherapy and~     Nintedanib 200mg twice daily oral administration (PO) continuously. The primary diagnosis~     must be histologically confirmed and central pathological review of the presenting tumour or~     biopsy of relapsed disease must find at least 50% clear cell carcinoma with no serous~     differentiation~   "
53525|NCT02866357|"~     To assess the infective etiologies by quantitative polymerase chain reaction (qPCR) of acute~     exacerbation of COPD and asthma who required hospitalization.~      To identify the HRV subtypes that are associated with COPD and asthmaexacerbations.~      To assess if the infective aetiologies have associations with the clinical outcome of the~     patients.~   "
53526|NCT02866344|"~     This single-center, prospective, randomized clinical trial is designed to compare the~     clinical characteristics and outcomes of hepatic resection and microwave ablation (MWA) to~     determine the optimal operative intervention for the local treatment of resectable colorectal~     cancer liver metastases. The primary aim of this study is to test the following hypothesis:~     2-year local disease control is equivalent between patients receiving the experimental~     therapy (MWA) and patients receiving the standard therapy (hepatic resection) as treatment~     for colorectal cancer liver metastases determined to be resectable by radiographic imaging.~     Secondarily, the investigators expect that 2-year intrahepatic (regional) and metastatic~     disease recurrence rates are equivalent between the two treatment arms in this study.~   "
53527|NCT02866331|"~     This study is performed to reveal the safety and feasibility of combination therapy with~     autologous cord blood mononuclear cells (CB) and G-CSF as well as repeated administration of~     G-CSF for children with cerebral palsy. The evaluation tools are as follows: (1)~     Developmental tests (DDST, PEDI, GMFM, GMFCS, MACS, QUEST), (2) Neurocognitive function test~     (WPPSI-IV), (3) Brain MRI-DTI, (4) Peripheral blood CD34+ cell counts, (5) Neurotrophic~     factors/anti-inflammatory cytokines.~   "
53528|NCT02866318|"~     This retrospective, cross-sectional cohort study was conducted to investigate the novice~     practitioners' learning curve of visual estimation of LV ejection fraction (%) through a~     echocardiographic video files at the academic emergency department (ED) in tertiary urban~     hospital.~   "
53529|NCT02866305|"~     Knowledge about incidence, risk factors and genetic predispositions of primary spontaneous~     pneumothorax in young adults is very limited, and treatment has also been controversial.The~     Aim of this study is to optimize the treatment, estimate the actual incidence, and identify~     possible risk factors including genetic predispositions.~   "
53530|NCT02866292|"~     This study has two aims: a) to evaluate the pelvic floor muscles strength in primigravid and~     non-pregnant nulliparous women and to correlate with their sexual function and b) to compare~     PFM strength and sexual function between women in the second and third pregnancy trimesters.~   "
53531|NCT02866279|"~     The investigators goal is to measure the impact of timing of postpartum contraceptive implant~     insertion on breastfeeding success and duration and to explore women's experiences with and~     attitudes towards contraceptive and breastfeeding counseling in the peripartum time period~   "
53532|NCT02866266|"~     Study to evaluate the impact of the ER/LA opioid REMS program on the incidence of Emergency~     Department visits and hospitalizations for overdose/poisoning and death among patients~     prescribed ER/LA opioid analgesics.~   "
53533|NCT02866253|"~     The purpose of this study is to compare the effect of pre-IVF cycles treatment with and~     without DHEA(Dehydroepiandrosterone) on the ovarian reserve markers, the number of oocytes~     obtained and IVF(in vitro fertilization) outcomes of DOR(diminished ovarian reserve) patients~     and the expression of BMP-15(bone morphogenetic protein 15),GDF-9（growth differentiation~     factor 9) and IGF-I(insulin-like growth factors-1) in follicular fluid.~   "
53534|NCT02866240|"~     This is a single site, non-randomized, prospective, open-label, interventional~     pilot/feasibility study. Patients recruited will have medically-refractory focal neocortical~     epilepsy, defined on the basis of presence of focal spikes and (if available) focal seizure~     onsets originating from the lateral cortical surface of any lobe. Patients will be recruited~     from the epilepsy clinics of Boston Children's Hospital (BCH) and Beth Israel Deaconess~     Medical Center (BIDMC), the home institutions of the principal investigators. All patients~     and referring physicians will be requested to maintain their current antiepileptic drugs~     throughout the study with changes after enrollment permitted only to maintain pre-enrollment~     drug levels, or if clinically necessary. The primary outcome measure will be the change in~     seizure frequency (seizures/4-week period) as compared to baseline. Secondary outcome~     measures include change in interictal discharge burden, change in cortical excitability, and~     quality of life measures.~      Patients with medically-refractory neocortical epilepsy will receive cathodal tDCS~     administered to the seizure focus for 10 sessions over a 2-week period with the allowance of~     make-up sessions in week three. Subjects will be evaluated at baseline, during the~     stimulation sessions, and 4 and 8 weeks after the completion of the tDCS visits~   "
53535|NCT02866227|"~     This is a Phase II study designed to assess the safety and efficacy of an investigational~     product, TOL-463, to treat vaginitis.~   "
53536|NCT02866214|"~     The Purpose of this study is to determine if the Febuxostat has an effect on endothelial~     dysfunction on hemodialysis patients.~   "
98052|NCT02283801|"~     Single centre, open-label, multiple doses, one-sequence design study in two parallel groups~     of healthy volunteers~   "
53537|NCT02866201|"~     Traveler's diarrhoea or turista is the most common disease in travelers. It has been reported~     based on studies in 20 to 60% of travelers, depending among other conditions and travel~     destinations. Currently, less than 30% of the etiology of diarrhoea is identified by~     bacteriological v,irological and parasitology traditional techniques. This ignorance of the~     diarrhoea etiology causes difficulties in the establishment of a specific and rapid~     management in this extremely common condition and having a significant cost to society.~     Technological advances in laboratory diagnosis, such as quantitative real-time Polymerase~     Chain Reaction (PCR), can allow us now to improve the etiological diagnosis of traveler's~     diarrhoea using simple rectal swabs.~      So, the principal objective of this study is to assess the efficacy of a new diagnosis~     strategy in order to establissh the etiological diagnosis of traveler's diarrhoea. The~     hypothesis consists in improving the number of patients with a confirmed etiological~     diagnosis of traveler's diarrhoea by 5%.~   "
53538|NCT02866188|"~     In this study, we want to find out whether the recognition of cardiac arrest using a smart~     watch is feasible or not. If this idea is possible, the recognition of cardiac arrest using~     the smart watch is easy and fast to the witness, like a general person. By using the smart~     watch, the emergency response system for cardiac arrest and the bystander CPR or BLS is~     beginning earlier than using conventional cardiac arrest recognition method in field.~   "
53539|NCT02866175|"~     There are insufficient data on the safety and efficacy of edoxaban plus antiplatelet therapy~     in subjects with atrial fibrillation AF following percutaneous intervention PCI with~     stenting. This study is designed to evaluate the safety and to explore the efficacy of an~     edoxaban-based antithrombotic regimen versus a vitamin K antagonist VKA-based antithrombotic~     regimen in subjects with AF following PCI with stent placement. Bleeding is a central safety~     outcome in cardiovascular clinical trials, especially for antithrombotic strategies and~     invasive procedures.~   "
53540|NCT02866162|"~     Syndromic congenital neutropenia (SCN) includes a heterogeneous group of diseases~     characterized by congenital neutropenia associated with the involvement of other organs. Most~     patients have syndromic congenital neutropenia, which does not correspond, either clinically~     or genetically, to any other previously described form. A large number of genes still have to~     be identified in these syndromic forms.~      The aim of this study is to identify the molecular bases of congenital neutropenias that have~     not yet been classified, by taking advantage of high-throughput exome sequencing.~   "
53541|NCT02866149|"~     Exploratory study on blood-borne biological markers and their correlation with clinical and~     pathological characteristics.~   "
53542|NCT02866136|"~     Conservative treatments of retinoblastoma (RETINO 2011)~        1. -Multicentric non randomised, phase II study for the patients treated by chemoreduction~          (VP16, carboplatin) followed by chemothermotherapy without laser treatment at day 8~        2. -Multicentric non randomised, phase II study for the patients with bilateral very~          asymmetric dis-ease (Group D eye on one of the eye) or unilateral presentation groups~          B/C/D according to the age and vitreous seeding~        3. - Multicentric non randomised, phase II study for the patients treated by 6 cycles of~          three drugs regimen and local treatments for bilateral group D eyes or on the only eye.~   "
53543|NCT02866123|"~     There are several ways to verify the correct positioning of a gastric tube. Radiography is~     considered the reference method. The use of ultrasonography could diminish the number of~     radiographies necessary. The hypothesis of this research is that gastric ultrasonography~     performed during insertion of the tube is a reliable examination to check the correct~     positioning of gastric tubes in intensive care.~   "
53544|NCT02866110|"~     Emotion-related brain activation is made visible for patients via neurofeedback with the aim~     to improve discriminability of emotional arousal and emotion regulation. With functional~     magnetic resonance imaging (fMRI), information of current brain activation is imaged and fed~     back to the patient via a visual display. Patients with borderline personality disorder (BPD)~     usually hyper-activate brain regions associated with emotion. In this study, BPD patients~     will be provided with neurofeedback from the amygdala, which is crucial for the processing of~     emotions. The aim of the study is to observe, whether amygdala-neurofeedback would help BPD~     patients to improve emotion regulation. Compared to a control condition, improved brain~     self-regulation and emotion regulation is expected with three neurofeedback training~     sessions.~   "
53545|NCT02866097|"~     This study will provide important evidence to the Ministry of Community Development, Mother~     and Child Health (MCDMCH) and the Ministry of Health (MOH) on how to effectively implement~     iCCM with a focus on improving both the flow of supplies to CHWs as well as the quality of~     their supervision and mentorship. The overall aim will be to determine whether improvements~     in supplies for community health workers (CHWs) and strengthened supervision result in~     improved early and appropriate treatment for children with malaria, pneumonia, and diarrhea~     in rural Zambia when compared to CHWs offering iCCM without this logistics and supervision~     support.~   "
53546|NCT02866084|"~     This is a non-randomized pilot study to test the efficacy of neuromodulation via caloric~     stimulation on vestibular migraines. All subject who meet the study criteria will be in an~     active treatment group. All subjects will report the frequency of the migraines and undergo~     periodic testing of symptoms.~   "
53547|NCT02866071|"~     STUDY SYNOPSIS Objectives The primary objective is to estimate the proportion of subjects who~     report clinically important reductions in pain score (defined as 2 points on a 0-10 verbal~     numerical rating scale) after receiving a single dose of fentanyl (per local standard) with~     or without intranasal (IN) ketamine (50mg) prior to hospital arrival for the treatment of~     acute traumatic pain.~      Design and Outcomes This protocol describes two linked studies conducted as a prospective,~     randomized, placebo-controlled single-site clinical trial. The primary study has a primary~     outcome variable of reduction of reported pain of at least 2 points (on the 0-10 Verbal~     Numerical Rating Scale1,2) when comparing the pretreatment pain score to the pain score~     obtained upon reassessment 30 minutes after medication administration; secondary outcomes of~     the primary trial include reduction of reported pain at Emergency Department (ED) arrival;~     the incidence of adverse events; additional opiate requirements prior to ED arrival and in~     the first three hours of ED care. The secondary study explores secondary outcomes including:~     development of chronic pain (measured by the Brief Pain Inventory,3) or post-traumatic stress~     disorder (measured by the PTSD Checklist for DSM-54) and overall satisfaction with life~     (measured by the Satisfaction With Life Scale5) at 90-days after injury.~      Interventions and Duration Adult men who qualify for prehospital pain treatment under~     paramedic standing orders will be screened for inclusion and will undergo informed consent~     for the primary trial. After ED arrival, subjects who consented for the primary trial will be~     approached for inclusion in the secondary trial. Prehospital consent for primary trial~     enrollment and study drug administration will occur concurrent with receiving a single dose~     of fentanyl (IV, IM or IN per current standard practice). Consenting subjects will be 1:1~     randomized to receive either 50mg IN ketamine or IN saline placebo. Pain will be rated on a~     0-10 scale by the subject prior to treatment and at 30 minutes following treatment and will~     receive further pain assessments at 30 minute intervals for the first three hours of their ED~     care. Additional pain medications given prior to hospital arrival and within the first three~     hours of ED care will also be recorded. The primary outcome of the primary trial will be~     reduction in baseline pain between the pretreatment measurement and 30 minutes after~     medication administration. Consent for the secondary trial will be obtained for the~     additional baseline assessments for secondary outcomes and at 90-day follow-up. Overall~     satisfaction with life and symptoms of PTSD and chronic pain will be assessed before hospital~     disposition (in-person) and via phone follow-up at 90-days (+/- 14 days) after injury.~      Sample size and Power We consider a 2-point reduction in pain to be clinically significant,~     and thus our primary outcome for the primary trial will compare the proportion of subjects~     achieving a 2-point reduction in pain at 30 minutes post-medication administration between~     the treatment group and the control group. Sample size considerations are based on this~     primary analysis. To test the hypothesis that the proportion of those treated with fentanyl~     alone that have at least a 2-point reduction in their pain will be lower than the proportion~     of those treated with the combination of fentanyl and single-dose ketamine who have a 2-point~     reduction in their pain, we will use a chi-square test (or the Fisher's Exact Test if~     appropriate). An intent to treat approach will be used. We expect the response rate in the~     two groups to be 40% and 60%, respectively. These estimates are based on the response rates~     in a study comparing pain management efficacy between subjects treated with morphine alone~     and morphine plus ketamine.6 With this magnitude of effect, a sample size of 97 per group~     will have 80% power to detect the difference between the two groups when the critical level~     of significance is set to 5%. To allow for subject drop-out, protocol deviations, and missing~     outcome data, we plan to enroll an additional 15% in each arm, for a total of 224 subjects.~   "
53548|NCT02866058|"~     This study will examine the effect of cesarean section on perinatal mortality, using data~     provided by the Canadian Institute for Health Information.~   "
53560|NCT02865902|"~     Objective: The aim of this study was to determine the effects of Low Level Laser Therapy~     (LLLT) on wound healing at Free Gingival Graft donor sites (FGGDS).~      Materials and Methods: Forty patients requiring FGG were selected for this randomized~     controlled double blinded prospective clinical trial. The FGGDS were treated with LLLT and~     compared with an untreated control group. The Wound Healing Index (WHI), tissue consistency,~     colour match (CM), and H2O2 bubbling test for the evaluation of complete wound~     epithelialization (CWE) were recorded at the 3rd, 7th, 14th and 21st days. The pain-burning~     level, number of analgesics, and bleeding were recorded for 7 days. Donor area soft tissue~     thickness (TT) was measured at baseline and at the 1st month.~   "
53580|NCT02865642|"~     In this study the investigators want to test the hypotheses that, serotonergic~     neuromodulation increases perilesional neuroplasticity, leading to improved behavioural~     outcomes through a more efficient allocation of functional resources, greater structural~     reorganization and less remapping via alternative circuits.~   "
53549|NCT02866045|"~     Sub epithelial lesions (SELs) of the gastrointestinal (GI) tract are commonly identified~     during routine endoscopy. Most of these lesions are benign. However because there is the~     potential for malignant transformation it is important to correctly identify the lesion in~     order to determine if any further therapy and/or surveillance is necessary for the patient,~     particularly for gastrointestinal stromal tumors (GISTs).~      Obtaining a definitive diagnosis for SELs is often difficult since biopsies of the normal~     overlying surface mucosal layer are typically normal. EUS-FNA is the standard method by which~     a biopsy-proven diagnosis is obtained for most SEL's. However, the yield for a definite~     diagnosis from EUS-FNA for SELs is often suboptimal. Recently a new biopsy method, called~     single incision needle-knife (SINK) was introduced that may prove more useful in~     determining a definitive diagnosis. Furthermore, recent advances in core biopsy needles for~     EUS offer the hope for improved outcomes with EUS-guided fine-needle biopsy (FNB). However,~     it remains unclear whether superior diagnostic outcomes are obtained using the new SINK~     biopsy method or using new EUS-FNB core needles.~   "
53550|NCT02866032|"~     The primary objective of this study is to evaluate the efficacy of topical MOB015B in~     patients with mild to moderate distal subungual onychomycosis (DSO).~      The secondary objective is to evaluate the safety of topical MOB015B in patients with mild to~     moderate DSO.~   "
53551|NCT02866019|"~     The purpose of this study is to evaluate the efficacy and safety of esophageal epithelial~     regenerative treatment by the transplantation of the product, CLS2702C, to the esophageal~     wound site after extensive ESD for superficial esophageal cancer.~   "
53552|NCT02866006|"~     BVAC-C is immunotherapeutic vaccine using B-Cell and Monocytes as antigen presenting cell.~     This study is Open-label, dose-escalation, multiple dosing study to evaluate the safety,~     tolerability, immune response and pre efficacy of BVAC-C in patients with multiple metastatic~     progressive or recurrent HPV type 16 or 18 positive cervical cancer after failure to standard~     care. 9~18 patients will be enrolled~   "
53553|NCT02865993|"~     The purpose of this study was to evaluate, for the first time in Literature, the effects of~     betadine washing versus normal saline washing after uterine closure in women undergoing~     cesarean section (CS) at ≥36 gestational weeks in terms of post CS infections, complication,~     fever and pain.~   "
53554|NCT02865980|"~     This randomized clinical trial will conducted involving 60 patients under hemodialysis and~     hospitalized to Imam Reza and Montasareyeh hospitals of Mashhad in 2016. Patients were~     assigned to experimental and control groups of 30 people, randomly (double block). In the~     both intervention and control group, first will be washed the Catheter with Betadine, but in~     intervention group, after 2 minutes will be used of the clove extract with 2 ml of scrub for~     15 seconds. The incidence and severity of inflammation as well as infection of vascular~     access will be assessed in patients on hemodialysis for each patient before starting the~     process over a period of 2 weeks is equivalent to 6 sessions of hemodialysis.~   "
53555|NCT02865967|"~     Asthma is the most common chronic condition in children and one of the five most burdensome~     diseases in the United States. Despite this, research and care for childhood asthma are~     limited by inefficient utilization of electronic medical records (EMRs) to facilitate~     large-scale studies and care.~      The primary goal of this clinical trial is to implement the asthma-Guidance and Prediction~     System (a-GPS) on the Asthma Management Program (AMP, a current care coordination program for~     asthma care of children aged 5-17 years at Mayo Clinic). Primary hypothesis: The~     implementation of a-GPS in the current care is logistically feasible.~   "
53556|NCT02865954|"~     he postpartum period is vulnerable to dysfunction of the pelvic floor musculature, which is~     associated with incontinence, pain, reduced stability of the core and functional deficits.~     The Society of Obstetricians and Gynaecologists of Canada recommends instruction on the~     correct performance of pelvic floor muscle exercises, commonly known as Kegels, as standard~     care. However, only a small proportion of women seek medical care for incontinence in Canada.~     Recently, there has been an influx of mobile Health technology applications marketed for~     pelvic floor restoration and fitness that have not been studied. The existence of mHealth~     technologies may represent an innovative mode to support pelvic health, however systematic~     exploration to substantiate claims and proposed benefit is required. This pilot study aims to~     understand the utility of a new mobile health application, iball, as a rehabilitation tool to~     promote optimal pelvic floor function and to correct pregnancy related pelvic floor~     dysfunction. The iball is comprised of a device and a mobile app, and it has been brought to~     market in Europe as a consumer product. The study aims to assess the acceptability,~     feasibility, and effectiveness of the iball as a pelvic floor muscle training intervention,~     in comparison to standard care.~   "
53557|NCT02865941|"~     It has been observed that target fortification on different schedules leads to meal to meal~     variation. It changes the ratio of protein to energy and the percentage of carbohydrate to~     non-protein energy which may, affect growth. In the past, the investigators have analyzed the~     outcomes of breast milk composition when target fortification is done with different analysis~     schedules. The investigators were able to measure the macronutrient intake for different milk~     analysis schedules via a theoretical model and show that the more frequent schedules reduce~     the variation of fortified-breast milk, whereas a reduced schedule leads to a high variation~     of macronutrients. It was observed that, in all the breast milk samples measured twice per~     week, infants achieved on average the recommended macronutrients in line with current~     recommendations. Nonetheless, the model only looks at the macronutrient intake and does not~     investigates the relationship between macronutrient variation and its effect on growth.~      The aim of the current study is to compare a frequent schedule of measurement of~     macronutrient analysis with a reduced schedule of measurement and to study its affect on~     growth, protein accretion and metabolic parameter.~   "
53558|NCT02865928|"~     This is a randomized, double-blinded, placebo-controlled trial of serratus plane blocks in~     subjects undergoing outpatient unilateral or bilateral breast surgery. Ninety subjects will~     be enrolled into the study at presurgical testing. Subjects will be stratified based on~     surgery type and randomized to receive a serratus plane block with either bupivicaine HCL or~     placebo. All patients will receive standard intraoperative anesthesia and standard~     postoperative pain control. The primary endpoint is the amount of opioid administered~     postoperatively. Secondary endpoints include postoperative pain intensity at timed intervals,~     amount of opioid administered intraoperatively and postoperatively, incidence of nausea and~     vomiting, time to discharge and patient satisfaction~   "
53561|NCT02865889|"~     Laparoscopic surgery is gaining currency in the field of oncologic care, particularly for~     colorectal and gynecologic cancers. This innovation could be used either for staging purpose~     and therefore could steer global therapeutic options or for surgical management only.~      Increase knowledge and skills lead to an increase in the number and rate of the women this~     innovation could be offered. The project team observed a shift from traditional surgical~     management (abdominal radical surgery) towards laparoscopic with a focus on lymphadenectomy.~      This innovation however increases some costs (the surgical stage) but decrease some others~     (the post surgical stage).~      Foreseeing the pace of the dissemination needs to have objective and reliable data about who~     had access to laparoscopic surgery and who didn't (and why) and accurate assessment of~     related costs.~      This program will focus on uterine cancer (both cervix and corpus).~   "
53562|NCT02865876|"~     The objective of this study is to evaluate the efficacy and safety of accelerated~     cross-linking (Avedro Inc., Waltham, USA) in the management of microbial keratitis as~     adjunctive therapy.~   "
53563|NCT02865863|"~     A phase II randomized, placebo controlled study evaluating the efficacy of~     Eurycomalongifoliawater extract (Physta®)+Multivitamin on quality of life and mood on 86~     healthy adults over a 24 week supplementation period.~   "
53564|NCT02865850|"~     A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction or~     maintenance treatment of anemia in subjects with incident DD-CKD.~   "
53565|NCT02865837|"~     The purpose of this study is to compare, for each patient, dosimetry of organs at risk~     (bladder, rectum, sigmoid, small bowel) in two bladder distension procedures (emptied by a~     urinary catheter or filled with 120cc) during PDR 3D image-guided brachytherapy of cervical~     cancer.~   "
53566|NCT02865824|"~     Current guidelines recommend discontinuation of antiplatelets (i.e clopidogrel) for 7 days in~     patients taking DAT (dual antiplatelet therapy) before colonoscopy and polypectomy. The~     purpose of this study was to examine if a) discontinuation of these drugs reduces bleeding~     risks during polypectomy and if b) discontinuation of these drugs increases the occurence of~     thromboembolic events.~   "
53567|NCT02865811|"~     This research study is studying the combination of Pegylated Liposomal Doxorubicin (PLD) and~     Pembrolizumab as a possible treatment for Recurrent Ovarian, Fallopian Tube or Peritoneal~     Cancer that is resistant to platinum therapy.~      The following interventions will be used in this study:~        -  Pegylated liposomal doxorubicin (PLD)~        -  Pembrolizumab~   "
53568|NCT02865798|"~     Valvular heart diseases (VHD) are the most common causes of mortality and morbidity after~     coronary artery disease, hypertension, and heart failure, especially in senile patients who~     have more comorbidities and often require intervention. The prevalence of senile VHD is~     increased gradually as the growth of the age. In addition important changes have occurred as~     regards the presentation and treatment of the disease over recent years. However, there is~     little information about senile VHD in China. The purposes of this study are to evaluate the~     clinical characteristics, reasons for hospitalization, risk stratification, treatment~     modalities, quality of life and outcomes of senile hospitalized patients with VHD, to~     determine the risk factors affecting the prognosis, further to lay the foundation for~     establishing a prognosis model suitable for Chinese senile VHD.~   "
53569|NCT02865785|"~     The aim of present study is to evaluate the effect of intralipid 20% infusion, once between~     days 4 and 9 of the ovarian stimulation, and again within 7 days of a positive pregnancy test~     on clinical pregnancy rates in women with unexplained recurrent implantation failure.~   "
53570|NCT02865772|"~     The aim of this study to determine the reference ranges of LBC on gastric aspirate in healthy~     term newborns.~   "
53571|NCT02865759|"~     To improve pregnancy outcome, 39 000 pregnant women will be randomized to receive information~     about Mindfetalness or to routine care. The level of randomization will be the antenatal~     clinics in the Stockholm area.~   "
53572|NCT02865746|"~     The objective of this randomized double-blind study was to evaluate the effect of~     betamethasone in the control of postoperative pain in patients undergoing endodontic~     treatment.~   "
53573|NCT02865733|"~     The aim of this study is to determine the safety and efficiency of Remodulin®（Treprostinil~     Injection）to reduce the pulmonary arterial pressure and prevent pulmonary hypertension (PH)~     after Fontan operation with univentricular physiology.~   "
53574|NCT02865720|"~     The purpose of this study is to determine if an investigational treatment is safe and well~     tolerated when administered by intravenous (IV) infusion in Japanese subjects with HAE.~   "
53575|NCT02865707|"~     Ulcerative colitis (UC) is a relapsing chronic intestinal inflammation with no existing cure,~     that affects over 300 per 100.000 Canadians, the highest prevalence in the world. The~     standard drug therapies are expensive and potentially toxic, and mostly directed against the~     chronic inflammatory process. UC is the result of a dysbiosis between disease-inducing and~     protective intestinal bacteria in a genetically susceptible host. Non-digestible dietary~     carbohydrates (NDC) stimulate the growth of protective endogenous intestinal bacteria which~     ferment them into short-chain fatty acids (SCFA), some of the latter with natural~     anti-inflammatory properties, and are called prebiotics. The investigator was the first to~     report that oral intake of NDC, the dietary β-fructans inulin plus fructo-oligosaccharides~     (FOS), reduced colitis in a genetically-induced rat colitis model. Both inulin and FOS~     reduced colitis, each NDC modifying specific luminal microbiota. A small trial with the same~     mixture of NDC in patients with active UC relapsing on oral 5-aminosalicylic acid (5-ASA)~     showed a dose-dependent clinical response, confirming the translational potential of this NDC~     mixture.~      The investigators propose a randomized placebo-controlled trial to assess if inulin plus FOS~     can also prevent such relapses in UC patients with inactive disease on stable maintenance~     drugs. Primary hypothesis is that inulin plus FOS is effective adjunct therapy to standard~     drugs for maintaining clinical remission. The second hypothesis is that the colonic~     microflora and its metabolic function, altered by inulin plus FOS, or not, mediate protection~     or relapse in UC. The longitudinal design of this maintenance prevention study and by~     serially collecting colon biopsies, stool, serum and urine within the same patient before a~     relapse (inflammation) occurs, would enable to identify unique changes in the intestinal~     microbiota, their metabolic functions and also assess effects on host-immune response that~     are associated with remission or before a relapse occurs during treatment with beta-fructans,~     or not.~   "
53576|NCT02865694|"~     Familial hypercholesterolemia (FH) is a most prevalent genetic disorder define as high~     cholesterol level and premature death. The prevalence of FH reported in few countries however~     unknown in Iran. Thus determine the FH patient, finding diagnostic strategy and appropriate~     treatment are important. We intent to use cascade method to screening patients, also our~     expected outputs are to develop and implement a registry program for FH patients and their~     families and to study their genetic disorder. FH patients will be followed from management,~     treatment and prevention of Cardio vascular disease in order to increase premature death.~   "
53582|NCT02865616|"~     MET-2 clinical study is an Open label, single center, multiple dose pilot study of 20~     patients. The study is designed to measure the resolution of diarrhea as well as the~     feasibility of administration and safety of MET-2 for the treatment of recurrent CDI in~     patients who have experienced at least two prior episodes of CDI and have developed~     recurrence after having completed standard-of care oral antibiotic therapy to treat CDI.~   "
53583|NCT02865603|"~     The aim of this study is to measure the impact of the intervention (PAX GBG) in~     Estonian-language 1st grade classrooms on students' mental health and behaviour, and~     teacher's self-efficacy.~   "
53584|NCT02865590|"~     The sinus infiltration technique for sinus floor elevation has been used successfully when a~     reduced vertical height is available in the posterior maxilla. However, the effect of the~     different graft material on the volume and on the quality of new bone formed has not been~     fully investigated. The aim of this study is to evaluate the clinical and histological effect~     of a test material, lyophilized equine bone (Bio-gen®), compared with control material,~     deproteinized bovine bone (Endobon®), in the sinus lift techniques with lateral approach.~   "
53585|NCT02865577|"~     Poor function of the right side of the heart and rise in pressure of the blood vessels~     leading to the lungs are two main heart-related factors that are associated with worsening of~     airway disease. A relatively new method which uses magnetic field to create images of the~     heart called cardiac magnetic resonance (CMR) imaging shows immense promise in detailed and~     accurate assessment of the heart in patients with airway diseases. This project aims to~     assess the heart in patients with asthma and chronic obstructive pulmonary disease (COPD) as~     well as healthy participants using CMR to help us determine features on CMR that are~     different is patients with asthma and COPD compared to healthy participants. This may help~     with early identification of patients who are at risk of episodes of acute worsening of~     airway disease, called exacerbation, and potentially halt the progression of the heart~     dysfunction with currently available or new treatments.~      Study involves one visit at Glenfiled Hospital, Leicester, lasting approximately 4 hours. The~     visit will include following assessments: clinical history, health status, physical~     examination, electrocardiogram (ECG), blood tests, lung function testing, echocardiogram and~     CMR. Part of the study will involve a participant questionnaire in which the participants~     will rate their CMR experience. The results will potentially change the way CMR is~     undertaken. A sub-set of the participants will also be invited back to do a one off focus~     group discussing the CMR experience further.~   "
53586|NCT02865564|"~     The aim of the study is to elucidate the relationship between postnatal antibiotic~     administration on development of gut microbiota and possible protective influence of~     simultaneously administration of probiotic during antibiotic therapy on development of gut~     microbiota, functional gastrointestinal disorders of infancy, weight gain and body~     composition.~   "
53587|NCT02865551|"~     The investigators intend to compare the rate of urinary retention among female patients after~     vaginal delivery under epidural anesthesia, depending on bladder catheterization type, either~     by a foley catheter inserted adjacent to epidural anesthesia or intermittent catheterization~     applied every 4 hours during labor.~   "
53588|NCT02865538|"~     This is a multi-center, double-blind, randomized, placebo-controlled multiple ascending dose~     study in post-menopausal women with vasomotor symptoms. Single ascending doses of NT-814 will~     be investigated in 4 cohorts. Each cohort will comprise of 20 subjects. Subjects will be~     dosed for 14 days.~   "
53589|NCT02865525|"~     Medication non-adherence is an economic problem and a major public health challenge. Factors~     influencing medication adherence can be modelled according to five dimensions: disease,~     medication, patient and its close relatives, demographic and socioeconomic factors and health~     care system. A tool is needed to qualify medication adherence in order to adapt tailored~     support for individual patients to promote and optimize adherence to therapy.~      The objective of this work is to present the preliminary results of QUILAM project which is~     divided into 3 phases: 1. Development of a tool to assess barriers to medication adherence in~     chronic patient (COPD, Heart failure, Type 2 diabetes) ; 2. Validation of the instrument~     (especially against clinical criteria) ; 3. Evaluation of the sensitivity of the tool during~     educational interventions.~   "
53590|NCT02865512|"~     It is known that postoperative pain after thoracotomy or lobectomy is very severe, therefore,~     intraoperative or postoperative pain management using continuous thoracic epidural~     catheterization is suggested good option to prevent this complication.~      The spread of local anesthetics is influenced by various factors including volume, location~     of needle insertion, speed of injection, patient position, age, weight and height. However,~     there are few studies about the effect of different patient position during thoracic epidural~     catheterization.~      This study was designed to evaluate the effect of different patient position affecting~     thoracic epidurography.~   "
53591|NCT02865499|"~     This study addresses a lifespan approach to healthy development and aging with direct~     relevance to humans by testing the anti-aging effects of acarbose in humans. It is a pilot~     study to: i) better estimate power for a larger trial, ii) establish the safety and potential~     beneficial effects of acarbose in non-diabetic elderly humans, and iii) determine whether the~     effects of acarbose on the microbiome likely play a role in its enhancement of longevity~     and/or healthy aging. These are essential initial steps for translating acarbose into an~     anti-aging human therapy.~   "
53592|NCT02865486|"~     In this randomized, double blind, unbalanced three way crossover trial, four lipid emulsions~     will be assessed on three study days. The lipid emulsions (LEs) have been engineered so that~     they differ in terms of acid stability, lipid droplet size and fat redispersibility. The~     investigators hypothesize that the gastric emptying of fat will differ between the lipid~     emulsions.~      An optional study day (visit 5) will be used to assess the degree of lipolysis in Lipid~     emulsion 5 (LE5) and Lipid emulsion 6 (LE6). This study day is a randomized, single blinded~     study.~   "
53667|NCT02864498|"~     The purpose of this study is to determine whether orally administered DS107 (1g and 2g doses)~     is effective in the treatment of moderate to severe atopic dermatitis.~      Oral DS107 capsules will be administered for 8 weeks and will be compared against placebo.~      The study will enroll approximately 300 subjects.~   "
53742|NCT02863510|"~     A pilot, single-center, prospective, interventional study. The objective is to demonstrate~     that catheter-based renal denervation using carbon dioxide renal angiography in patients with~     moderate to severe chronic kidney disease can be performed for treatment of uncontrolled~     hypertension.~   "
53593|NCT02865473|"~     The aim of the present study is to develop a measurement protocol for optimal imaging of the~     anterior segment of the eye, including anterior chamber angle, Schlemm's canal, filtering~     bleb and pseudoexfoliation deposits on the lens based on measurements in patients with~     glaucoma and PEX. In glaucoma the structures of the anterior chamber are important for~     classification, therapy, progression and prognosis and imaging of the angle between the iris~     and the cornea is the key for open angle and closed angle glaucoma differential diagnosis.~     For this purpose, a customized ultrahigh resolution Spectral Domain OCT will be used to~     validate whether the protocol can also be more widely applied in these patients. Based on the~     obtained measurement protocol, further studies investigating anatomy and pathophysiology of~     the anterior segment of the eye as well as surgical outcome in patients with glaucoma and PEX~     can be planned.~      The aim of the study is to develop a measurement protocol for OCT imaging and~     characterization of the anterior chamber in glaucoma patients.~   "
53594|NCT02865460|"~     The primary objective of this clinical trial is to determine if treatment with ubiquinol, a~     form of coenzyme Q10, improves the physical function of men and women Veterans suffering from~     Gulf War Illness (GWI). The primary outcome measure is a change from baseline on the Short~     Form Health Survey 36-item (SF-36), with respect to physical functioning and symptoms.~     Secondary outcome measures include changes from baseline levels on GWI-associated biomarkers~     in peripheral blood and GWI-associated symptoms of chronic pain, fatigue, insomnia, activity~     level, and cognitive and mental functioning.~   "
53595|NCT02865447|"~     Sponsor is conducting this post-market study to evaluate the clinical outcome and femoral~     bone mineral density (BMD) changes associated with the PROFEMUR® PRESERVE hip stem when used~     as indicated for primary total hip arthroplasty in patients with osteoarthritis of the hip~     joint.~   "
53596|NCT02865434|"~     Prospective, open-label, multicenter, dose escalation, safety with pharmacokinetics (PK) and~     dosimetry study of injected Tc 99m tilmanocept in the detection of and assessment of~     localization to skeletal joints in subjects with and without active RA by SPECT imaging.~   "
53597|NCT02865421|"~     Androgenetic alopecia (AGA) is a common form of hair loss in both men and women,~     characterized by progressive patterned loss of hair from the scalp. The current study has~     been designed for restoration of hair in AGA by using a combination of stromal vascular~     fraction (derived from the adipose tissue) and human platelet rich plasma.~   "
53598|NCT02865408|"~     Enhancing the anabolic effect of nutrition in critically ill patients by administering~     exogenous amino acids.~   "
53599|NCT02865395|"~     Ureteroscopy is a common procedure in Urology that patients undergo daily to deal with a~     variety of ailments. These procedures often require that the bladder be filled and emptied~     with sterile water or saline several times during the procedure, and often result in the~     patient receiving a catheter at the end of the procedure. One common side effect is that~     patients experience bladder spasm or discomfort for a period of time after these procedures.~     Belladonna and Opium (B and O) suppositories and PO Oxybutynin are often given in the~     post-operative setting to relieve these symptoms.~      The principle objectives of this study are:~        1. To determine if the addition of a B and O supprette suppository at the end of~          cystoscopic/ureteroscopic procedures reduces the incidence of bladder spasms and urinary~          discomfort that patients experience in the post-operative setting.~        2. To determine if using peri-operative B and O supprette suppositories reduces the need~          for pos-operative oral Ditropan and use of narcotic pain medications.~   "
53600|NCT02865382|"~     Optical Enhancement Technology might be superior to the conventional HD-WL in detecting~     colorectal adenomas~   "
53601|NCT02865369|"~     A study on regression of liver fibrosis assessed by transient elastography after Daclatasvir~     and Asunaprevir combined treatment in advanced fibrotic/cirrhotic patients with chronic~     hepatitis C genotype 1b Infection~   "
53602|NCT02865356|"~     The study is designed as a proof of concept, multi-center, randomized, double-blind and~     vehicle-controlled study with intra-individual comparison of treatments.~      Three age cohorts of patients will be included in the study according to the following age~     ranges:~        1. ≥18 years old (minimum 6, maximum 18 patients)~        2. >12 - 17 years old (minimum 6, maximum 18 patients)~        3. >2 - 12 years old (minimum 6, maximum 18 patients)~      The main objectives of study are:~      To assess the efficacy of SP14019-F-01 topical solution (5% cyclosporine A [CsA]) compared to~     placebo topical solution for the treatment of patients with mild to moderate atopic~     dermatitis (AD).~      To evaluate the safety and tolerability of SP14019-F-01 (5% CsA) topical solution in patients~     with mild to moderate AD.~   "
53603|NCT02865343|"~     The investigators have an existing exercise program (N>70) with a unique population of~     individuals with spinal cord injury (SCI) who have been enrolled in FES-RT for at least 6~     months. Roughly half have high level SCI. Thirty individuals with high level SCI who have~     FES-row trained for at least 6 months will be randomized to (continued) FES-RT for 4 months~     with either NIV or sham NIV. Before and after training, the investigators will assess maximal~     aerobic capacity, ventilation, cardiac output, and arterio-venous oxygen difference. Based on~     the investigators current data, it is hypothesized that only those randomized to NIV will~     experience further increases in aerobic capacity and that these increases will relate to~     increases in cardiac output and arterio-venous oxygen difference. This~     Exploratory/Developmental Research project will lay the groundwork for a larger study of the~     impact of FES-RT+NIV to improve health and function in those with high level SCI.~   "
53604|NCT02865330|"~     Description:~      Multicentre observational study, not randomized. Ambispective character (retro and~     prospective). Opened to any member of the Asociación Española de Urología (AEU), public and~     private medicine.~      Justification:~      Active surveillance is a strategy proposed to control the overtreatment derived from the~     opportunist screening in prostate cancer (PCa).~      Its development in our country is erratic and different in every Center. This database tries~     to include most of patients included in active surveillance in Spain with a few minimal~     inclusion criteria.~      Multicentre registry and follow up of the active surveillance in Spain.~      Hypothesis:~      Mortality cancer specific for PCa includible in active surveillance to 15 years is lower than~     5 %.~   "
53605|NCT02865317|"~     Cortical activity during rest and with stimulation by functional magnetic resonance imaging~     will be investigated in patients with OBPI.~   "
69951|NCT02651350|"~     This study is to observe the efficacy and safety of glucocorticosteroid treatment in the~     patients with chronic recurrent drug-induced liver injury (DILI).~   "
53607|NCT02865291|"~     The ForConti Fecal Incontinence Management System (FIMS) is indicated for the management of~     accidental bowel leakage due to bowel incontinence. The ForConti FIMS is designed for~     self-insertion to seal and help prevent the involuntary leakage of stool, liquids and gases~     from the rectum.~      The purpose of the study is to demonstrate that the ForConti FIMS is safe and that it~     improves management of fecal incontinence and improves quality of life.~      Patients will record bowel events in a daily diary over a 5 week period, which includes 1~     week of adjustment to device use, 2 weeks without using the device followed by 2 weeks using~     the device. Quality of Life questionnaire will be completed before and after use of the~     device. Stool leakage data collected when the device is not being used will be compared with~     data collected during use of the device to determine effectiveness.~   "
53608|NCT02865278|"~     Randomized placebo-controlled crossover study during which participants undergo two different~     experimental days. The participants consume a red grape based- drink (polyphenols: 300 mg/100~     ml and sugar: 9.8g/100 ml) or a placebo (no polyphenols and sugar: 9.8g/100 ml). After 3~     hours they consume a test meal (905 kcal, 15% protein, 46% fat, 39% CHO). Blood samples are~     taken at fasting, over 3 hours after drink consumption and over 5 hours after the test meal~     to evaluate metabolic response. Fasting and 48h-urine are collected to evaluate~     bioavailability.~   "
53609|NCT02865265|"~     The association between ultrasound-guided Pecs II block and parasternal block can represent a~     valid alternative in the management of acute and postoperative pain syndrome after~     quadrantectomy with or without axillary dissection.~   "
53610|NCT02865252|"~     Osteoarthritis (OA) is the most prevalent form of arthritis and is reported to be the most~     important reason behind functional disability and musculoskeletal disorders among aged~     individuals. OA is a total joint failure; represented by pathological damage to articular~     cartilage, that affects bone, menisci, synovium, ligaments, and neuromuscular tissue. Knee~     OA could be responsible for pain and functional disability in 19.2% of individuals aged more~     than 45 years in the Framingham study and in 27.8% of such individuals in the Johnston County~     Osteoarthritis Project. However, in the third National Health and Nutrition Examination~     Survey (NHANES III), nearly 37% of individuals aged 60 years or older had radiographic knee~     OA. Oliveria et al. (1995) reported that age- and sex-standardized incidence rates of~     symptomatic hip, knee, and hand OA were 88, 240, and 100/100,000 person-years, respectively.~     In addition, the incidence rates of symptomatic OA of the knee, hand, or hip increased~     rapidly at age 50 and then levelled off beyond age 70. There were not enough data to report~     the prevalence of OA in Arabic countries. However, a cross-sectional study performed in Saudi~     Arabia demonstrated radiographic knee OA in 53.3% of men and 60.9% of women, while about 18%~     of women and 10% of men had symptomatic OA. Although it is well established that OA is mainly~     caused by damage occurring in the joint because of degeneration and inflammation, there is no~     known cure for OA and our understanding of the pathological aetiology of OA is still~     deficient and poorly understood.~      The primary objective of this study is to investigate the immediate and the carry-over effect~     of MWM on pain and function in patients with knee OA. A secondary objective is to evaluate~     this effect among those patients who demonstrate features of central sensitization.~   "
53611|NCT02865239|"~     Breast MRI is performed in prone position which causes a number of questions. Indeed, the~     correlation with mammography and echography and the identification of preoperative lesions~     can be complex as echography and surgery are carried in supine position while mammography is~     performed in standing position.~      Moreover, the prone position is often considered as uncomfortable by the patients. However,~     there is few publications in the literature on breast MRI in decubitus position.~   "
53612|NCT02865226|"~     Post-thoracotomy pain is one of the most severe. The local analgesia allows its effective~     control and a reduction of postoperative morbidity and mortality.~      The gold standard for local analgesia is the thoracic epidural. However, this technique can~     be dangerous with severe complications.~      The paravertebral block showed comparable efficacy to the thoracic epidural for local~     analgesia . In addition, it has a better safety profile. There are several installation~     techniques. The difference in efficiency of these laying techniques is unknown.~   "
53613|NCT02865213|"~     This experimental study will evaluate the effect of different methods for the molar intrusion~     (compared with the control group) in adolescent and adult patients with open bite~     malocclusion. The study sample will consist of 45 patients with anterior open bite. The~     sample will be randomly allocated into two experimental groups, in addition to a control~     group.~      The investigators will apply a modified version of the Open Bite Appliance (OBA), by Erverdi~     and Usumez, for all patients in upper posterior teeth. For this purpose, miniplates will be~     used in the first treatment group, while miniscrews will be used in the second treatment~     group. In the control group, only OBA will be used. The skeletal and dentoalveolar changes~     occurring after intrusion of posterior teeth will be assessed by using posteroanterior and~     lateral cephalometric radiographs. Pre- and post- treatment changes for each group will be~     evaluated, in addition to the comparison of the post-treatment skeletal and dental changes~     that occurs between groups.~   "
53614|NCT02865200|"~     Aim: This study was planned for comparing physical activity levels, nutrition quality and~     quality of life of the individuals that are diagnosed with and without metabolic syndrome~     (MetS) and that live in the Turkish Republic of Northern Cyprus (TRNC).~      Method: 1200 individuals in total, in which (n: 660) individuals diagnosed with MetS and~     (n:660) individuals not diagnosed with MetS, participated in this study. Socio-demographic~     characteristics of the individuals that participated the study were registered with a survey~     form. The long form of the International Physical Activity Questionnaire was used for~     determining physical activity levels of the individuals; whereas total numbers of daily steps~     were carried out with pedometer. The 14-item Mediterranean Diet Adherence Screener (MEDAS)~     was used for the assessment of dietary habits, Nottingham Health Profile (NHP) was used for~     the assessment of health-related qualities of life of individuals and Beck Depression~     Inventory (BDI) was used for the assessment of depression. In addition, biochemical analysis~     and anthropometric measurements of individuals were also taken.~   "
53702|NCT02864043|"~     The NvisionVLE® Dysplasia Detection Pilot Study is a prospective, non-randomized trial for~     participants who have a prior biopsy-confirmed diagnosis of BE with dysplasia and are~     scheduled to have an endoscopic evaluation of your esophagus for BE surveillance by a~     standard procedure called EGD (esophagogastroduodenoscopy) as well as an imaging procedure~     called VLE (volumetric laser endomicroscopy).~   "
53615|NCT02865187|"~     SUMMARY:~      Polycystic ovary syndrome (PCOS) is the most common endocrine disorder among reproductive age~     women with a prevalence as high as 15%. The clinical symptoms of PCOS including menstrual~     dysfunction, infertility, hirsutism, alopecia, acne, and the possible increased risk of~     diabetes and cardiovascular disease have been reported to be significant contributors to~     psychological morbidity and impact health-related quality of life. For women with PCOS, the~     changes in physical appearance and the associated mood disorders appear to be deleterious for~     sexual function.~      Vitamin D deficiency (<20 ng/ml serum concentration of 25[OH]D), which affects from 67% to~     85% of women,4 is closely linked to symptoms of PCOS. The main physiologic role of vitamin D~     is to regulate calcium and phosphorus homeostasis and to promote bone health. Although there~     has been an increase in awareness of the importance of sexual dysfunction and QoL in women~     with PCOS, few studies have evaluated the outcomes of treatment for PCOS upon sexual and~     subjective health status of women.~      The goals of this study are:~        1. To evaluate the prevalence of sexual dysfunction (SDy) in women with Polycystic Ovarian~          Syndrome (PCOS)~        2. To determine the effects of Vitamin D therapy, with and without hormonal contraceptives,~          on SDy in women with PCOS in the absence of depression.~      METHODS:~      The study will enroll 60 women diagnosed with PCOS and reporting SDy at the Wright State~     Physicians (WSP) OB-GYN Practice and the WSP Family Medicine Practice.~      All participants will take vitamin D 600IU/day and will choose between hormonal and~     non-hormonal contraceptive methods (target of 30 participants in each group). Participants~     will complete three study visits (Initial, Month 3, and Month 6). Vitamin D levels will be~     drawn at the beginning of the study and again at 3 and 6 months after initiation of vitamin D~     therapy. Each participant will be asked to complete the Female Sexual Function Index (FSFI)~     and the Beck Depression Inventory (BDI) prior to initiation of treatment and again at 6~     months.~   "
53616|NCT02865174|"~     Our purpose of this study is to conduct a prospective randomized controlled trial to~     investigate the blood-conservation effect of this two topical hemostatic agents in primary~     TKA procedures in patients with a risk of thromboembolic events. We will also observe if~     there is increased risk of thromboembolism by use of topical hemostatic agents.~   "
53617|NCT02865161|"~     This study is conducted to study the efficacy and safety of Niselat in patients with~     osteoarthritis.~   "
53618|NCT02865148|"~     Research indicates that up to two-thirds of patients with advanced cancer experience~     significant symptom burden (e.g., anxiety and depression, pain, fatigue), yet these symptoms~     are not adequately addressed. Cognitive behavioral therapy (CBT) protocols designed to teach~     patients strategies to increase their sense of self-efficacy to manage symptoms may be~     helpful in alleviating multiple cancer-related symptoms. The efficacy of CBT protocols for~     reducing distinct symptoms in early-stage breast cancer has been shown; however the role of~     CBT protocols for multiple symptoms in late-stage cancer is less clear. The current study~     aims to investigate the feasibility and acceptability as well as obtain an initial estimate~     of efficacy of a novel, cross-cultural CBT intervention that addresses multiple symptoms in~     advanced breast cancer patients. The target outcomes of intervention will be reduction in~     symptoms of anxiety and depression, pain, and fatigue. A randomized controlled design will~     compare patients receiving a CBT protocol to a waitlist control in both Singapore and US~     patients. The larger goal of this collaborative effort is to determine the scalability of~     such an intervention that can potentially provide needed symptom burden relief to advanced~     cancer patients.~   "
53619|NCT02865135|"~     This research study is studying a therapeutic vaccine, named DPX-E7, as a possible treatment~     for Human Papilloma Virus or HPV related head and neck, cervical or anal cancer (positive for~     HLA-A*02).~   "
53620|NCT02865122|"~     The objective of this clinical study is to evaluate the efficacy and safety of NTRA-9620~     compared with placebo in pediatric subjects (aged 28 weeks postmenstrual age to 52 weeks old)~     with SBS following surgical resection~   "
53621|NCT02865109|"~     To provide access to nusinersen to eligible patients with Infantile-onset Spinal Muscular~     Atrophy (SMA) (consistent with Type 1) to address a high-unmet medical need.~   "
53622|NCT02865096|"~     This study is attempting to determine whether there is any effect (worsening or improvement~     of sexual function) after marijuana consumption. Both users and non users of marijuana will~     be given the opportunity to participate by completing a questionnaire.~   "
53623|NCT02865083|"~     The purpose of this study is to investigate the effects of the Traxi Pannus retractor in~     obese patients (BMI ≥30 kg/m2) who undergo Cesarean sections compared to routine pannus~     retraction techniques. Patients will be randomized to the use of the Traxi retractor during~     Cesarean section (treatment group) or the use of traditional pannus retraction techniques~     (control group). The primary outcome to be followed is surgical site disruption. The~     investigators will also assess the duration of surgery or length of time from skin incision~     to delivery of the infant, change in hemoglobin, estimated blood loss, postoperative length~     of stay, need for hospital readmission or emergency room visits, or other complication rates~     between the two groups.~   "
53624|NCT02865070|"~     This is a pilot study is to test a wireless, skin-sensor device against current technology in~     the NICU to monitor vitals~   "
53625|NCT02865057|"~     Vaginal exams are used routinely in labor to assess cervical dilation and position of the~     baby (facing anterior, facing to the right or left side, facing towards maternal spine). This~     technique has a widely variable accuracy rate (24.0-85.6%). Ultrasound has been used to help~     confirm or correct the vaginal assessment by obstetricians, but has not been used to assess~     the utility of immediate feedback to improve the accuracy of vaginal assessment by physicians~     in training. The investigators plan to use ultrasound assessment to determine if this~     education is effective in increasing accuracy in the resident population.~   "
53626|NCT02865044|"~     The objective of this study was to evaluate and compare the acute bioavailability of EPA and~     DHA in wax ester form provided as a dietary supplement compared to a well-studied and defined~     ethyl ester formulation in generally healthy men and women.~   "
53627|NCT02865031|"~     Purpose: To determine the safety, tolerability, and efficacy of human recombinant decorin~     protein, a transforming growth factor ß (TGFß) inhibitor in preventing proliferative~     vitreoretinopathy (PVR) in patients with perforating globe injuries.~      Methods: This is a prospective, single-center, open-label, interventional case series. A~     single intravitreal injection of decorin 200ug (n=4) and 400ug (n=8) was given within 24~     hours of injury. Pars plana vitrectomy with silicone oil injection was done if indicated. ERG~     was done before injections, at day 10, and 3 months. Serial plasma decorin levels were~     assessed before injections, day 3, 5, and 10 post-injection. Clinical assessment included~     globe survival, retinal attachment rate, and PVR evaluation.~   "
53743|NCT02863497|"~     This study aims to determine if there is an impact on sexual distress using mindfulness-based~     sex therapy (MBST) in addition to standard urogynecologic care, in women with both urinary~     incontinence (UI) and sexual dysfunction.~   "
53628|NCT02865018|"~     Neuromyelitis optica (NMO) is an autoimmune disease that affects the central nervous system.~     Patients have relapses (also known as attacks) which are often quite severe and leave them~     with significant disability. Without treatment, within 5 years 50% of NMO patients are blind~     in one or both eyes or require walking assistance (cane, walker or wheelchair).~      NMO has only been relatively recently described and is fairly rare. Most NMO patients' immune~     systems produce abnormal antibodies against aquaporin-4 (AQP4), which is found in certain~     cells in the central nervous system. When these AQP4 antibodies bind to AQP4, they trigger a~     cascade of events involving the immune system which eventually leads to damage to the nervous~     system. This ultimately leads to disability, some of which is permanent.~      Until now, treatments for NMO have been mostly focused on decreasing production of this AQP4~     antibody. However, recent experiments in animal models of NMO have shown the importance of~     what happens inside the central nervous system after the antibody binds to the nervous system~     cell. Specifically, researchers have noted the importance of a specific cell type,~     eosinophils, in causing damage in NMO lesions. In a recent study, researchers showed they~     could prevent damage from NMO by blocking eosinophils using cetirizine, which is a popular~     over-the-counter allergy medicine.~      Cetirizine is already known to be safe and well-tolerated in the general population. In this~     study, the researchers plan to add cetirizine on to patients' current NMO treatment. The~     researchers aim to show that it is safe, well-tolerated, and that with cetirizine, NMO~     patients have less relapses and therefore less disability over the course of the year~     following initiation of treatment. The researchers also plan to study how cetirizine changes~     the immunological profile in NMO patients by examining blood and cerebrospinal fluid.~   "
53629|NCT02865005|"~     Multi-center, double-blind, randomized, placebo-controlled trial of Dapsone 5.0% Gel in the~     treatment of acne vulgaris.~   "
53630|NCT02864992|"~     This study will look at how effective the study drug (tepotinib) is at stopping the growth~     and spread of lung cancer. This study will also measure a number of other things including~     safety of the study drug and the side effects, how body processes the study drug, or how the~     study drug affects your quality of life. The study also has an optional pharmacogenetic~     research part. Pharmacogenetic research is an important way to try to understand the role of~     genetics in human disease and how genes impact the effectiveness of drugs, because~     differences in genes can change the way a person responds to a particular drug.~   "
53631|NCT02864966|"~     This is a 24 hour patch test to determine the acute tolerance of 3 variants of condom on a~     panel of healthy adult subjects. The patches will be affixed to the back and remain under~     occlusion for 24 hours. They will then be assessed at 30 minutes and 24 hours post patch~     removal.~   "
53632|NCT02864953|"~     This study evaluates the use of the investigational drug BIIB093 versus placebo in patients~     with a large hemispheric infarction.~   "
53633|NCT02864940|"~     The study aim is to determine if periodic online cognitive exercises (Lumosity) improve~     memory function in ruptured cerebral aneurysm patients with disabling baseline memory~     deficits within the first 24 months after rupture. Half of the subjects will be randomized to~     use Lumosity-designed online cognitive exercises and half will serve as an active control~     group performing online crossword puzzles.~   "
53634|NCT02864927|"~     The purpose of the study is to perform the re-examination of Menactra® administered in the~     routine clinical settings in accordance with the Ministry of Food and Drug Safety regulation.~      Primary objective:~        -  To describe the safety profile after 1 dose of Menactra® administered from 9 months to~          55 years of age under standard health care practice.~   "
53635|NCT02864914|"~     Empagliflozin (Jardiance), a highly potent and selective inhibitor of the sodium-glucose~     cotransporter 2 (SGLT2), was approved in Europe in May 2014 for the treatment of type 2~     diabetes mellitus (T2DM) to improve glycaemic control in adults. As part of the risk~     management plan, Boehringer Ingelheim International GmbH (BI) has committed to conduct a~     post-authorisation safety study (PASS) to evaluate the liver and renal safety of~     empagliflozin. The study will also evaluate the risks of severe complications of urinary~     tract infections (UTIs) and genital infections. To evaluate the association between~     empagliflozin use and mentioned outcomes routinely collected health information from the~     Clinical Practice Research Datalink (CPRD), the Hospital Episodes Statistics, and Office of~     National Statistic will be used. This PASS will be conducted through an observational cohort~     study among adult patients with T2DM and at least 12 months of continuous enrolment in the~     CPRD where new users of empagliflozin will be compared to new users of other SGLT2 inhibitors~     and to new users of dipeptidyl peptidase-4 (DPP4) inhibitors. Estimations will be made on the~     crude and adjusted incidence rates and adjusted incidence rate ratios of the primary and~     secondary outcomes. The primary outcomes will be: acute liver injury (ALI), acute kidney~     injury, hospitalization due to severe complications of urinary tract infection, and genital~     infections. The secondary outcomes will be: ALI in patients without predisposing factors,~     chronic kidney disease, outpatient severe complications of UTI, and genital infections~     resulting in hospitalization or systemic treatment.~   "
53636|NCT02864901|"~     This study is a Phase 2 two-armed placebo-controlled, double-blind, randomized (1:1),~     multiple dose, single center study to evaluate the safety and proof of concept in a chewing~     gum formulation 3 times per day over 4 treatment days.~   "
53637|NCT02864888|"~     The primary objective of this protocol study is to investigate the effect of Antineoplaston~     therapy on the QT/QTc interval in study subjects age 3 to 21 years with newly-diagnosed,~     diffuse, intrinsic brainstem glioma. This investigation is to be conducted in parallel with a~     phase 3 efficacy and safety study of combination Antineoplaston therapy + radiation vs.~     radiation alone (BRI-BT-52).~   "
53638|NCT02864875|"~     The objetive of this study is to compare the treatment of two groups of politrauma patients~     that have fibrinogen deficiency (Fibtem < 9) diagnose by thromboelastography (ROTEM) but do~     not have clinical or laboratorial signs of coagulopathy at emergency room admission. One~     group will receive fibrinogen concentrate (Haemocomplettan) and the control group will be~     clinically followed. If any of the groups show clinical signs of coagulopathy it will be~     treated by anesthesiologist decision.~   "
53639|NCT02864862|"~     The purpose of this study is to evaluate the esthetic outcomes following immediate implant~     combined with the autogenous tissue graft or acellular dermal matrix compared to immediate~     implant alone.~   "
53640|NCT02864849|"~     This study is designed to test the efficacy and safety of total neoadjuvant induction and~     consolidation CapeOX plus neoadjuvant intensity modulated radiotherapy with concurrent~     capecitabine for MRI defined high-risk rectal cancer.~   "
53744|NCT02863484|"~     The blood loss will be compared in middle fossa meningiomas which will receive pealing of the~     outer layer of the lateral wall of the cavernous sinus and those which will not revive~     pealing before the dura is opened~   "
54002|NCT02860104|"~     The investigators will perform this study to prospectively analyse the clinical outcome after~     percutaneous microwave ablation(MWA) of benign and malignant breast lesion under ultrasound~     (US) guidance.~   "
53641|NCT02864836|"~     The distribution of stable (non-radioactive) isotopes in living organisms is increasingly~     studied, in particular the zinc (Zn), copper (Cu) and iron (Fe), not only in primitive~     organisms, but also in mammals.~      The scientific community shows a growing interest in the study of the isotopic distribution~     of Cu in humans: this distribution can vary according to gender or nutrition. Concerning~     pathology, the isotopic distribution of Cu seems interesting in Wilson's disease or in~     cirrhosis.~      Additionally, a promising area of study focuses on the role of Cu in cancerous tumors,~     neoangiogenesis, the mechanisms of free radicals reduction and signaling pathways.~      Head and neck cancers are sensitive to platinum salts. Links between platinum and Cu are~     important: platinum penetrates into the cell through a Cu receptor, it interacts with the~     regulation mechanisms of Cu and platinum.~      Preliminary studies suggest a variation of the measurable isotopic distribution of Zn in~     patients with breast tumor and of Cu in patients presenting breast as well as colorectal~     tumors.~      The Larner et al. study suggest a promising role of Zn in breast cancer, indeed, results~     highlight a variation of distribution of Zn in 10 breast tumors. Concerning the study of~     Télouk et al. on 8 patients presenting colorectal tumors and 20 patients presenting breast~     tumors, results are in favor of an increase of mortality when Cu 65 is decreased in the serum~     and the isotopic modifications happen earlier than usual modifications of biochemical tumor~     markers such as: carbohydrate antigen (CA) 19.9, Carcinoma Antigen (CA) 15.3,~     Carcinoembryonic antigen (CEA).~      Currently, there is no information about the distribution of the stable isotopes of Cu in~     head and neck tumors.~      The objective of the study is to determine if the distribution of 65Cu / 63Cu is modified in~     tumoral tissues compared to healthy tissues. The isotopic distribution of the Cu in 2 tumor~     types, head and neck tumors and lymphomas, will be also investigated in order to determine if~     this distribution is specific of a tumor type or not.~      In case of positivity of this variation, the prognostic interest of these parameters will be~     evaluated.~   "
53642|NCT02864823|"~     Necrotizing scleritis with severe ischemia is refractory to conventional treatment because of~     avascular necrosis.~      The investigators assessed the therapeutic efficacy and safety of autologous perichondrium~     transplantation in patients with severe ischemic necrotizing scleritis, and analyzed the~     therapeutic effects.~   "
53643|NCT02864810|"~     [18F]GP1 targets platelet GPIIb/IIIa receptor in thrombus. [18F]GP1 PET/CT imaging will~     noninvasively assess thrombus in whole body with good sensitivity with information of~     thrombus. Safety, pharmacokinetics, biodistribution, internal radiation dosimetry and~     diagnostic performance of [18F]GP1 will be assessed in all subjects.~   "
53644|NCT02864797|"~     Gynecologic cancers (cancers of cervix, endometrium, ovary, vagina, and vulva) represent an~     important part of the female cancer in France with more than 15 000 new cases in 2012. As~     considerable progress have been made in diagnostic and therapeutic strategies, an important~     part of the gynecologic cancers are diagnosed at an early stage and globally, the after~     treatment overall survival rate is estimated to more than 80% at five years. Thus, it is of~     evident interest to study health related Quality of Life (QoL) among these patients who will~     continue to live after their cancer and to consider QoL as a primary end-point, beyond~     overall survival.~      The GYNEQOL (health related Quality Of Life of women with GYNEcologic cancer) group is a~     working group initiated in Besançon and whose goal is to investigate QoL of gynecologic~     cancers' patients. It gathers several entities from the hospital of Besançon, namely the~     Methodology and Quality of Life in Oncology Unit, the Gynecologic Unit and the Oncology Unit.~     The GYNEQOL study is a project of a prospective cohort study, in a pragmatic clinical~     practice, with the main objective of longitudinally collecting and analyzing QoL data of~     these women.~      The pilot phase, GYNEQOL-Pilot, restricted to the hospital of Besançon, has started in~     September 2015 with the goal of assessing the feasibility of the cohort. The feature of this~     study is that patients answer to QoL questionnaires using tablets computer and the~     Computer-based Health Evaluation System software (CHES). Indeed, use of electronic solutions~     to collect patient reported outcomes is drastically increasing those last years. It has been~     underlined that routinely collecting symptoms could increase both QoL and survival among~     cancer patients. It enables to use these data in real-time in routine practice by presenting~     QoL scores to physicians in simple graphical histograms for both transversal and longitudinal~     measurements and it ensures a reliable data collection.~   "
53645|NCT02864784|"~     Studies objectives:~      To evaluate the safety, tolerability and efficacy of AMOR-1 given in combination with ZA or~     with Denosumab as compared to placebo given with ZA or with Denosumab as outline below:~        -  Safety and Tolerability:~        -  Adverse events (AEs) and serious AEs~        -  Safety laboratory measurements~        -  Hypercalcemic and hypercalciuric episodes~        -  Treatment withdrawal due to AEs and overall~      Efficacy:~        -  Skeletal Related Events (SREs)~        -  Measurable and evaluable disease progression~        -  Progression Free Survival (PFS)~        -  Pain assessment via the VAS scale~   "
53646|NCT02864771|"~     The purpose of this study is to identify markers of increased risk for incident ventricular~     arrhythmias and cardiovascular events in patients already being treated with an implantable~     cardioverter-defibrillator (ICD) by exploring patient history and clinical findings,~     biological markers, ECG markers, and echocardiographic markers.~   "
53647|NCT02864758|"~     The purpose of the study is to compare the one-year and two-year risk of each of the~     following individual outcomes: Stroke and systemic embolism (SE), major bleeding and death~     between new users of anticoagulant for Stroke prevention in atrial fibrillation (SPAF) during~     drug exposure: rivaroxaban versus Vitamin K antagonists (VKA), and rivaroxaban versus~     dabigatran~   "
53648|NCT02864745|"~     ICU acquired weakness contributes (ICUAW) to poor functional outcome in survivors of critical~     care. Most damage occurs during the first week of critical illness when patients are unable~     to cooperate with conventional active rehabilitation. Functional electrical~     stimulation-assisted cycle ergometry (FES-CE) may improve muscle function and long-term~     outcome. Methods: Assessor-blinded pragmatic single-centre randomized controlled trial.~     Adults (n=150) mechanically ventilated for < 48 hours from 4 ICUs who are estimated to need~     >7 days of critical care will be randomized to receive either FES-CE-based intensified~     rehabilitation or routine care, which will continue until ICU discharge. Primary outcome:~     Quality of life as measured by SF-36 score at 6 months. Secondary outcomes: functional~     performance at ICU discharge, cross sectional muscle diameter and nitrogen balance, and~     muscle power. In a subgroup we will assess insulin sensitivity and perform skeletal muscle~     biopsies to look at mitochondrial function, fibre typing and regulatory protein expression in~     response to FES-CE.~   "
53649|NCT02864732|"~     The purpose of this study is to investigate the feasibility of applying neuromuscular~     electrical stimulation on the lumbar spine, to report how tolerable the intervention is, and~     whether the electrical stimulation improve pain, function and muscle strength.~   "
53650|NCT02864719|"~     The primary aim was to examine the feasibility of an Energy Conservation + Problem Solving~     Therapy (EC+PST) intervention delivered over the telephone and to evaluate the preliminary~     intervention effect on fatigue impact in daily activities in post-cardiac arrest (CA) adults~     with chronic fatigue.~   "
53651|NCT02864706|"~     This protocol is written to describe the procedures for a single 5, 6 or 7 year follow-up~     control visit of patients who participated in the 12-month SCHEDULE-study and the following~     3-year follow-up examination/visit. The aim of this 5 to 7-year follow-up visit is to examine~     the effect of long term treatment, i.e. 5, 6 or 7 years, with early initiation of everolimus~     (Certican®) and early elimination of cyclosporine (CsA), compared to standard~     immunosuppressive regimen including CsA, on renal and heart function. During the time period~     of this follow-up examinations, this visit will be performed as part of a routine annual~     visit 5, 6 or 7 years since transplantation (and inclusion in the original SCHEDULE study).~   "
53653|NCT02864680|"~     This study will evaluate the impact of regular use of cannabis on the spatial sensitivity of~     magnocellular system (visual event-related potential, visual ERP).~      Secondary purposes of this study are to evaluate the impact of regular use of cannabis on the~     temporal sensitivity of magnocellular system (visual event-related potential), on the~     dynamics of cortical visual processing during face perception test (visual event-related~     potential) and on functioning of retinal photopic and scotopic systems (electroretinogram).~      The ancillary study is a genetic analysis of a group of candidate genes that aims to identify~     biomarkers for changes in visual processing. This will allow to distinguish among more~     homogeneous and specific groups in future studies on larger cannabis user population. This~     ancillary study concerns all participants subject to their informed consent (facultative~     study).~   "
53654|NCT02864667|"~     Koning Breast CT (KBCT) was approved by FDA PMA. The X-ray detector originally used in Koning~     Breast CT was PaxScan 4030CB. Recently, Koning Breast CT uses a modified X-ray detector~     PaxScan 4030MCT. The modified detector is essentially identical to the previous model except~     a different detector housing which allows a narrower dead-space between the active area and~     the top of the housing.~      The benefit of the modified detector is that it allows Koning to modify the patient exam~     table, achieving a flatter surface in the center. The flatter surface will increase patient~     comfort and improve workflow.~      Meanwhile, flatter surface may also affect patient positioning and the coverage of the~     breast. The adequacy of the overall image quality with the new table/detector should be~     verified by radiologists.~   "
53655|NCT02864654|"~     Adipose-derived regenerative cells (ADRC) will be extracted from lipoaspirate by enzymatic~     digestion. 10 mL of autologous ADRC suspension injected intramuscularly, close to the site of~     muscle injury. All patients will receive cell therapy. This is a single arm study with no~     control.~   "
53656|NCT02864641|"~     The purpose of this project is to test the efficacy of Planet K, a mobile and web-based~     technology infrastructure specifically designed to (a) enhance youths' chronic kidney~     disease- and treatment-related knowledge through interactive and game-based educational~     materials; (b) support adherence to the treatment regimen through customized task prompts via~     mobile and web-based delivery; and (c) promote patient-provider communication through~     real-world data collection and feedback loops. Investigators will examine the effectiveness~     of the Planet K mobile app and website in improving treatment adherence, disease-related~     knowledge, transition readiness, condition management, and the psychological correlates of~     these variables in adolescents and young adults with chronic kidney disease (CKD).~   "
53657|NCT02864628|"~     A total of 96 subjects will be recruited into 5 groups. Each subject will receive either two~     vaccinations with MVA-BN-RSV vaccine or placebo.~   "
53658|NCT02864615|"~     Aim of this phase 1b study is to evaluate safety and preliminary efficacy of stereotactic~     body radiation therapy in patients with metastatic renal cell carcinoma treated with VEGFR,~     mTOR or immune checkpoint inhibitors.~   "
53659|NCT02864602|"~     This is a volunteer study examining the effect of different doses of IV dexamethasone on~     prolongation of median nerve block in the forearm.~   "
53660|NCT02864589|"~     The purpose of this study is to evaluate the feasibility and acceptability of two different~     modalities of therapist-guided Internet-delivered behaviour therapy (IBT) for children and~     adolescents (7-17 years) with Tourette's Disorder (TD) or Persistent (Chronic) Motor or Vocal~     Tic Disorder (PTD).~   "
53661|NCT02864576|"~     Cognitive remediation (CR) and aerobic exercise have separately shown promising results in~     schizophrenia cognitive improvement, despite this, the impact in improving functionality is~     still limited. Aerobic exercise increases Brain Derived Neurotrophic Factor (BDNF) levels,~     promoting neuronal and cognitive plasticity, which can maximize the impacts of CR. The aim of~     this randomized controlled trial is to study the efficacy of a 3-month intensive program that~     combines CR plus physical exercise comparing it to cognitive remediation plus a control~     activity.~   "
53662|NCT02864563|"~     Neuroblastoma (NB) is characterized by its wide heterogeneity in clinical presentation and~     evolution. Recent retrospective studies have revealed by CGH-array that the overall genomic~     pattern is an important prognostic marker which might be taken into account for treatment~     stratification.~      This protocol deals with a prospective analysis of the genomic profile established by~     CGH-array on the tumor samples obtained at the diagnosis of all the patients with NB in~     France, to obtain genomic profiles and being able to determine their prognostic impact in the~     various protocols of treatment. The objective of this study will be a better therapeutic~     stratification in the future trials, studies or protocols of treatment.~   "
53663|NCT02864550|"~     Syphilis is a sexually transmitted infection (STI) disproportionately affecting gay, bisexual~     and other men who have sex with men (gbMSM), with the potential for significant sequelae -~     particularly in those who are Human Immunodeficiency Virus (HIV)-positive. Rising rates of~     this STI have prompted a search for novel prevention solutions. A recent pilot study of daily~     doxycycline prophylaxis demonstrated promise as a novel STI prevention tool. This innovative~     approach to STI prevention has solid clinical precedent, both from the HIV pre-exposure~     prophylaxis (PrEP) literature, as well as doxycycline's use as prophylaxis for other~     infections. The overarching goal of this project is to determine whether the daily use of~     doxycycline is an efficacious and acceptable intervention for syphilis prevention in~     high-risk, HIV-positive gbMSM.~   "
53664|NCT02864537|"~     The aim of the study was to compare self-management of anticoagulant treatment with~     conventional anticoagulant treatment in Norway.~   "
53665|NCT02864524|"~     Objective: Compare degree of improvement can reach patients diagnosed with fibromyalgia~     syndrome, by treatment with Manipulative and Massage Techniques versus an exercise program~     for lower thoracic and cervical spine.~      Study Design: A single-blind randomized controlled trial was conducted on patients with~     fibromyalgia syndrome (FMS).~      Setting: Clinical setting. Methods: Sixty-four subjects with FMS were randomly assigned to an~     experimental group receiving manipulative and massage therapy, or to a control group for~     exercise program.~   "
53666|NCT02864511|"~     The purpose of this study is to describe a safe and consistent technique for neck~     rejuvenation using botulinum toxin. This study will also evaluate the efficiency of the~     intervention and determine the patients that would benefit most.~   "
53777|NCT02863042|"~     The investigator hypothesizes that primary acute ankle deltoid ligament repair can help~     restore ankle radiographic congruity and functional outcomes.~   "
53668|NCT02864485|"~     Patients with unresectable liver metastases (LM) from colorectal cancer (CRC)have a poor~     prognosis. In patients with resectable disease, surgery offers a distinct survival benefit.~     This study will offer live donor liver transplantation (LDLT) to select patients with~     unresectable metastases that are 1) limited to the liver and 2) stable (non-progressing) on~     standard chemotherapy. Potential participants will be evaluated for liver transplant~     suitability and must also have a willing, healthy living donor come forward for evaluation.~     Those participants who undergo LDLT will be followed for survival, disease-free survival and~     quality of life for 5 years and compared to a control group of participants who drop out of~     study prior to transplantation due to reasons other than cancer progression.~   "
53669|NCT02864472|"~     The aim of this study is to compare the efficacy of early intervention of PDT combination~     compared with consecutive monthly treatment of intravitreal ranibizumab injections in PCV~     patients showing insufficient response with initial loading dose.~   "
53670|NCT02864459|"~     When attempting to wean a patient from the ventilator, even if he/she passes the spontaneous~     breathing test, 10-20% of the time extubation failure occurs and the patient is reintubated.~     When the patient is reintubated the mortality rate increases and the length of intensive care~     unit stay is also increased. It is vital to intensively assess the patient before extubation~     and correctly predict extubation success. Muscular ultrasound may be helpful in these~     situations.~   "
53671|NCT02864446|"~     Urinary intestinal fatty acid binding protein (i-FABP), a marker of intestinal mucosal cell~     damage, has recently been proposed as a clinically useful measure in the early detection of~     necrotizing enterocolitis (NEC). However, there are no data on urinary i-FABP in meconium~     obstruction of prematurity (MOP). This study aimed to evaluate urinary i-FABP in MOP patient~     as a marker for early detection.~   "
53672|NCT02864433|"~     The investigators aim to evaluated a public health program in Haiti that introduced an oral~     cholera vaccine as part of comprehensive control efforts for a major cholera epidemic.~     Although the vaccine (Shanchol(R)) had been demonstrated to be very safe, and effective at~     preventing cholera in many settings, it had not extensively been used to control an outbreak,~     and it had not been extensively studied in populations that were previously naive to cholera~     (i.e. countries that had never had cholera before). This cholera epidemic was the first ever~     report of cholera in Haiti.~      After the cholera vaccination campaign was complete, the investigators aimed to evaluate the~     field efficacy of the vaccination campaign by evaluating the number of cases of cholera, and~     determining if cholera patients had been vaccinated. The investigators compared the rate of~     vaccination in cholera cases to controls from the community that had not had cholera in a~     case-control study.~      The investigators also performed a second study - a bias-indicator study - that enrolled~     patients with non-cholera diarrhea, and community controls. The role of the bias-indicator~     study was to evaluate for potential sources of bias, since the investigators could expect~     that cholera vaccination should have no effect on non-cholera diarrhea.~   "
53673|NCT02864420|"~     The investigators propose a home hospital model of care that substitutes for treatment in an~     acute care hospital. Limited studies of the home hospital model have demonstrated that a~     sizeable proportion of acute care can be delivered in the home with equal quality and safety,~     reduced cost, and improved patient experience.~   "
53674|NCT02864407|"~     To monitor the safety profile and effectiveness of Vahelva Respimat in Korean patients with~     COPD in a routine clinical practice setting~   "
53675|NCT02864394|"~     The purpose of this study is to assess the efficacy of pembrolizumab (MK-3475) versus~     docetaxel in participants with non-small cell lung cancer (NSCLC) with programmed cell death~     ligand 1 (PD-L1) positive tumors who have experienced disease progression after~     platinum-containing systemic therapy. The primary hypothesis of this study is that~     pembrolizumab (MK-3475) prolongs overall survival (OS) and progression-free survival (PFS)~     compared to docetaxel in participants with PD-L1 positive tumors~   "
53676|NCT02864381|"~     The primary objective of this study is to evaluate and compare the efficacy of andecaliximab~     (GS-5745) in combination with nivolumab versus nivolumab alone in adults with recurrent~     gastric or gastroesophageal junction (GEJ) adenocarcinoma.~   "
53677|NCT02864368|"~     Newly-diagnosed glioblastoma (GBM) with complete or partial surgical resection, CMV~     seropositive patients will be eligible to enroll on this trial. Following standard of care~     chemoradiation, eligible subjects will be consented and begin adjuvant temozolomide (TMZ)~     cycles. Subjects will receive tetanus-diphtheria (Td) pre-conditioning on day 22 of the first~     post-radiation cycle of TMZ and the following day, receive the first of 3 every other week~     via intradermal (i.d.) injections of the study drug cytomegalovirus peptide (PEP-CMV), a~     vaccine mixture comprised in 2 components (referred to as Component A and Component B). The~     subjects will resume cycles of TMZ, resulting in a ~35-day delay between cycle 1 and 2, and~     continue PEP-CMV vaccinations every month with cycles of TMZ and then monthly to a maximum of~     20 vaccines unless progression occurs.~   "
53678|NCT02864355|"~     The objective of this prospective, randomized controlled study is to ascertain whether the~     perioperative use of the FloTrac device to guide fluid and vasopressor management during~     esophagectomy improves patient outcomes. The primary outcome is cardiopulmonary~     complications; however, the secondary outcome of decreasing patient morbidity (acute renal~     injury, anastomotic leak, and overall length of both ICU (intensive care unit) and hospital~     stay.~   "
53679|NCT02864342|"~     A randomized clinical study to assess the impact of Symbicort® pMDI medication reminders on~     adherence in COPD patients~   "
53680|NCT02864329|"~     Basic and clinical research is revealing that various noncoding and small RNAs play important~     and diverse roles in germ cell development and quality, including X/Y silencing during~     meiosis, gene regulation, DNA damage responses, and protection of the genome against~     transposable elements. Indeed, mammalian germ cells are known to harbor multiple small RNA~     species, including small interfering RNAs (siRNA), microRNAs (miRNA), and germline- specific~     PIWI- interacting RNAs (piRNA). However, their mechanistic roles in gametogenesis and human~     infertility are largely uncharacterized. The goal of this study is to elucidate the role of~     small RNA pathways in the events that give rise to viable euploid gametes. Four projects and~     three cores are included in this study.~   "
53681|NCT02864316|"~     The purpose of this study is to determine whether Nivolumab is effective in the treatment of~     radiation-induced solid tumors.~   "
53682|NCT02864303|"~     Although saliva is not generally regarded as one of the most interesting biological fluids,~     the fact that it can be sampled using simple, noninvasive methods makes it an interesting~     alternative to cerebrospinal fluid (CSF) or blood for diagnostic purposes. The use of~     salivary diagnostics is moreover increasing these past 10 years, as shown with the abundant~     literature as well as various clinical trials. Saliva collection which is now well~     standardized has the major advantage of being simple and non-invasive. An original study had~     already discussed possible changes in the salivary composition in Alzheimer's disease (AD).~     The feasibility and the potential interest of measuring saliva concentration of the amyloid~     peptides was reported in an article published recently. The prospect of using saliva for~     early diagnosis and monitoring of AD is thus of major interest and the objective of the~     current trial.~   "
53683|NCT02864290|"~     The purpose of this study is to evaluate the safety and tolerability of AGS62P1 given at~     three dosing schedules (Schedule A, every three weeks [Q3W] or Schedule B, every other week~     of a 4 week cycle [Q2W] or Schedule C once a week for 3 weeks of a 4 week cycle) in subjects~     with acute myeloid leukemia (AML) and determine the maximum tolerated dose (MTD). In~     addition, this study will assess the pharmacokinetics (PK), the immunogenicity and the~     anti-leukemic activity of AGS62P1.~   "
53684|NCT02864277|"~     The aim of this study is to compare outcomes of conventional perioperative care with those of~     an enhanced recovery after surgery (ERAS) perioperative care plan in women undergoing open~     abdominal surgery for gynecologic cancer or suspected gynecologic cancer. Investigators~     hypothesize that those patients randomized to the ERAS protocol will have shorter lengths of~     hospital stay, without increasing readmission rates. ASD~   "
53685|NCT02864264|"~     The primary purpose of this study is to determine if single and multiple doses of BMS-986184~     are safe and well tolerated in healthy male and female subjects. The primary purpose of the~     proof of mechanism study is to determine safety and efficacy in patients with ulcerative~     colitis.~   "
53686|NCT02864251|"~     The purpose of this study is to determine whether Nivolumab+ chemotherapy and~     Nivolumab+Ipilimumab is effective in the treatment of patients with EGFR mutation, T790M~     negative NSCLC who failed first line (1L) EGFR TKI therapy~   "
53687|NCT02864238|"~     The economic burden of health care is becoming a greater burden from year to year. Medicare~     spending, which represented 20 percent of national health spending in 2013, grew 3.4 percent~     to $585.7 billion, a slowdown from growth of 4.0 percent in 2012. This slowdown was~     attributed largely to slower enrollment growth and impacts of the Affordable Care Act (ACA)~     and sequestration. Per-enrollee spending in 2013 grew at about the same rate as 2012.~      The push to create Accountable Care Organizations (ACO) has taken these initiatives a step~     further. The goal would be to move away from a fee for service system and base reimbursement~     on quality of care. Clinical metrics, re-admissions, and patient satisfaction in categories~     of acute myocardial infarction, congestive heart failure, pneumonia, surgeries and healthcare~     associated infections will be the foci for 2013. Centers for Medicare and Medicaid Services~     (CMS) has also initiated a valve bundled payment system that encompasses total patient care~     for 90 days, including readmissions.~      Leapfrog and the ACO movement along with the nonprofit group Institute for Health Care~     Improvement have placed quality and cost effectiveness into the spotlight for clinicians in~     the ICU and beyond. While clinicians have always been focused on evidence based therapies~     with little concern for cost, in the new era of healthcare understanding cost, value and~     effectiveness of therapies will be key for improved patient outcomes and institutional~     solvency in trying economic times.~      Vanderbilt elected to enroll in the CMS valve bundle trial. The Leadership team in the heart~     and vascular institute identified the importance of an electronic medical record that~     includes display and utilization of key drivers of quality and success across the continuum~     of care (Preoperative assessment to discharge up to 90 days) in the bundled payment model of~     care. A multidisciplinary team was developed in conjunction with nurses, midlevel providers,~     multi-specialty physicians, case managers, informatics specialists, and performance~     improvement representatives to develop an electronic pathway of care using evidence based and~     best practices for cardiac surgery.~   "
53688|NCT02864225|"~     Background:~      Identification and measurement of fetal heart tracings throughout pregnancy and labor is~     crucial to the well-being of the fetus. Non reassuring fetal heart rate is one of the most~     common indications for operative vaginal delivery or cesarean section. Therefore, management~     of labor requires reliable and accurate information about fetal heart rate.~      In most normal spontaneous labors, fetal heart rate is characterized by the baseline heart~     rate (from 110 to 160 beats per minute), variability (beat to beat changes) and periodic~     changes (accelerations or decelerations). In each stage of labor the tracing may have~     different characteristics, with variable decelerations much more common at the end of the~     second stage of labor.~      Objective:~      To Show non inferiority of the EUM to the fetal doppler and scalp electrode by comparing the~     reliability and accuracy of the EUM versus fetal doppler compared to scalp electrode in the~     same patients.~   "
53689|NCT02864212|"~     The aim of this observational study is to create a data base to extract feature of~     fast-acting drugs that can be monitor in real time to design control strategies based on high~     order sliding mode controller to create a robust drug infusion system.~   "
53690|NCT02864199|"~     This study will evaluate the pharmacokinetics (area under the curve [AUC], maximum~     concentration [Cmax], and other parameters) and tolerability of peginterferon alfa-2a and~     ribavirin combination therapy following single and multiple doses in participants with CHC~     infection and moderate to severe renal impairment or end-stage renal disease (ESRD) receiving~     hemodialysis. The anticipated time on study treatment is up to 48 weeks, and the target~     sample size is 48 individuals.~   "
53691|NCT02864186|"~     That study have the primary purpose identify if exist difference to the healing and quality~     of life between women that use of a surgical support bra, common support bra and without~     support bra after coronary artery bypass graft surgery.~      To do this, will be assessed pain, healing of the wound (dehiscence, infection) and quality~     of life life through specific instruments.~   "
53701|NCT02864056|"~     This is a three-centre parallel group randomised controlled trial with an embedded process~     evaluation and intervention pilot phase (details not provided in this summary). The overall~     research question is: Can a Tai Chi exercise programme prevent falls among people with~     dementia (PWD), specifically among older PWD living at home?~      Primary Outcome measure:~      • dynamic postural balance (as a surrogate for falls).~      Secondary outcome measures:~        -  to explore the effects of a Tai Chi exercise programme on static and functional postural~          balance, fear of falling, cognitive functioning, falls, and quality of life. Also to~          explore the effects of a Tai Chi exercise programme on their informal carer's dynamic~          and static postural balance, quality of life, and carer burden~        -  to determine the acceptability and safety of the Tai Chi intervention~        -  to inform the design of a future definitive clinical trial.~   "
98356|NCT02279810|"~     The study evaluates the knowledge, attitude and practice about organ transplantation among~     medical students and medical staff.~   "
53692|NCT02864173|"~     Postoperative cognitive dysfunction (POCD) presents as a long-lasting decline in cognitive~     function following surgery. Recognized as an important neuropsychological complication of~     anesthesia and surgery, POCD occurs predominantly in elderly patients, and even after minor~     procedures. It affects 41% of patients over the age of 60 years one week after major~     noncardiac surgery, and persists until the third postoperative month in 13% of cases. POCD~     has an adverse impact on quality of life, may result in prolonged hospitalization and~     increased health care costs, and is associated with the risk of leaving the labor market~     prematurely and dependency on social transfer payments, as well as increased one-year~     mortality. Elderly patients are particularly at risk. Other risk factors include a~     pre-existing cognitive impairment, cerebral, cardiac or vascular disease, diabetes, alcohol~     consumption and a lower level of education. The occurrence of postoperative delirium seems to~     predispose patients to POCD. However, POCD itself is not associated with the development of~     dementia.~      The pathogenic mechanism leading to POCD remains unclear. Numerous etiologic pathways have~     been suggested: cerebral ischemia due to impaired intraoperative cerebral perfusion and/or~     oxygenation, systemic inflammation and the effect of proinflammatory cytokines on the brain,~     altered cholinergic neurotransmission, anesthetic neurotoxicity, hormonal changes induced by~     surgical stress, sleep or circadian disturbances, or genetic factors.~      Several studies have explored possible associations between a specific genotype and POCD;~     however, these were predominantly performed in patients undergoing cardiac surgery or carotid~     endarterectomy. Previous reports primarily focused on the analysis of the apolipoprotein E~     genotype as a predisposing factor for POCD. Results of some of these studies have been pooled~     in a recent meta-analysis. Other studies have investigated polymorphisms of the human~     circadian clock gene HPER3, complement, cytochrome P450, platelet glycoprotein IIIa,~     phosphodiesterase 4D, P-selectin, C-reactive protein, and the inducible nitric oxide synthase~     promoter.~      The primary aim of this retrospective study of available cohort data is to investigate a~     specific genotype and to identify single nucleotide polymorphisms (SNPs) which may predispose~     elderly patients undergoing major noncardiac surgery to POCD.~   "
53693|NCT02864160|"~     Language barriers continue to impede access to quality care for limited English proficient~     populations. Recent research has demonstrated that access to language concordant providers~     increases quality of care. This project evaluates the efficacy and acceptability of a model~     intervention to improve second language proficiency, patient-centered communication, and~     clinical competency of nurse practitioner students who care for Spanish-speaking patients~     with diabetes.~   "
53694|NCT02864147|"~     This is a randomized Phase II, three arm control trial in patients with Cervical~     Intraepithelial Neoplasia (CIN) 2/3 high grade cervical dysplasia. Patients with CIN 2/3~     meeting eligibility criteria will have cervical biopsy specimens centrally reviewed by study~     pathologist to confirm diagnosis. HPV DNA test and HPV 16/18 genotyping will be performed~     from endocervical cytobrush samples to determine HPV status associated with the dysplasia.~      Patients who have CIN 2/3 with HPV+ disease will be enrolled in this study. Patients will be~     randomized to one of three arms: observation only (control), imiquimod only, imiquimod +~     9-valent HPV vaccine.~   "
53695|NCT02864134|"~     BACKGROUND AND OBJECTIVES: The recent expansion of the applications of optical coherence~     tomography (OCT) demonstrated a higher correlation between the analysis of ganglion cells and~     visual function, in comparison with the analysis of the nerve fiber layer for several~     diseases of the optic nerve. Atrophy of the ganglion cells tends to induce the visual~     function deficits. In the case of optic neuritis, inflammation of the optic nerve causes a~     deficit of visual function initially with low vision, color blindness and visual field.~     Secondary atrophy of ganglion cell can result. The purpose of the study is to evaluate the~     correlation between the analysis of ganglion cells at the time of diagnosis of optic neuritis~     and the resulting visual acuity at 6 months and visual function (visual acuity, color vision~     and perimetry) 1 year regardless of treatment. A predictive effect could help predict the~     patient's clinical course and management of uncertainty and anxiety. MATERIALS AND METHODS:~     An assessment at diagnosis and follow-ups at 6 months and 1 year with a measurement of best~     corrected visual acuity, a test color vision HRR (Hardy-Rand-Rittler), an OCT with analysis~     of ganglion cells and perimetry Humphrey 30 -2 fast will be done. Simple linear and logistic~     regressions will be used. RESULTS: We expect that there will be a significant association~     between atrophy of ganglion cells in the diagnosis and residual visual function after an~     episode of optic neuritis. We believe that the initial atrophy is associated with poorer~     visual prognosis. CONCLUSION: A predictive effect could help to inform the patient about the~     evolution of the disease and provide early visual rehabilitation.~   "
53696|NCT02864121|"~     High-risk human papillomavirus (HR-HPV) are involved in cervical cancer development.~     Integration of HR-HPV DNA in cellular genomes is considered as a major event in the cervical~     cancer development. The aim of this study is to validate the integration of the HPV-HR as an~     appropriate biomarker of the severity of precancerous lesions and progression of cervical~     lesions towards cervical cancer. HR-HPV integration status will be analyzed by Molecular~     Combing technology, which allows direct and high-resolution visualization of the integration~     of high-risk HPV genomes.~   "
53697|NCT02864108|"~     The Human Trisome Project will significantly increase the speed of Down syndrome research and~     the understanding of associated medical conditions. Its biobank will provide de-identified~     samples to research.~   "
53698|NCT02864095|"~     The purpose of this study is to compare the blood loss of intravenous and topical~     administration of low dose epinephrine plus combined administration of intravenous and~     topical tranexamic acid for primary total hip arthroplasty.~   "
53699|NCT02864082|"~     Congenital ichthyosis (CI) is a large, heterogeneous family of inherited skin disorders of~     cornification resulting from an abnormality of skin keratinization, such as scaling and~     thickening of the skin. Treatment options include keratolytic agents, which can abruptly lead~     to extensive shedding or peeling of scales. PAT-001 primarily acts as a keratolytic agent;~     thus, making it a potential drug candidate for the treatment of skin disorders associated~     with hyperkeratinization, such as CI. The current study intends to evaluate the safety and~     tolerability of PAT-001 in patients with CI of either the Lamellar or X-Linked subtypes.~   "
53700|NCT02864069|"~     Vast evidence supports use of physical exercise and cognitive stimulation for lowering risk~     for cognitive decline and dementia, with combinations of non-pharmacological interventions~     providing greatest promise for impacting cognitive aging. This, paired with limited cognitive~     benefits from pharmacological interventions in dementia, has shifted focus to~     non-pharmacological interventions administered earlier in the disease course. This~     application, therefore, proposes a randomized controlled trial (RCT; 12-week active~     intervention, 3- and 6-month follow-up) comparing 3 conditions: walking program (guided~     progressive increases in weekly step counts), computer-based cognitive training program~     (Brain HQ, Posit Science), and combination of the exercise and cognitive program, on~     cognitive, functional, and diagnostic outcomes in 60 sedentary, community-dwelling adults~     with mild cognitive impairment (MCI).~   "
53703|NCT02864030|"~     On March 17th, 2011, the European Commission issued a marketing authorization valid~     throughout the European Union for Eribulin mesylate (Halaven; Eisai Limited), for the~     treatment of patients with locally advanced or metastatic breast cancer who have progressed~     after at least two chemotherapic regimens for advanced disease.~      As the use of Eribulin will be widespread in this tumor setting, a better knowledge of its~     safety profile outside clinical trials is warranted.~      Indeed the possibility to select patients at risk for developing Eribulin-induced neuropathy,~     will allow the exclusion from these treatment of those patients harbouring the specific~     single nucleotide polymorphism (SNP). Given that Eribulin toxicity often results in treatment~     discontinuation, the ability to anticipate which patients will experience severe toxicity~     could allow for either early intervention or even possibly for prophylactic therapy, or for~     selection of the patients to be treated.~   "
53704|NCT02864017|"~     The main objective of this study is to demonstrate that the only administration of~     L-citrulline, can improve immune functions in critically ill patients at high risk of~     nosocomial infection.~   "
53705|NCT02864004|"~     The aim of the study is to assess the use of the apomorphine pump in earlier stages of~     Parkinson' Disease (PD), when motor complications have just developed and before patients are~     significantly affected in their social and occupational functioning. The investigators~     hypothesize that apomorphine pump is superior in terms of positive impact on quality of life~     (QoL) to oral medical therapy alone at a relatively early stage of PD, before the appearance~     of severe disabling motor complications thus favoring the maintain of patients' social and~     occupational status with a significant positive economic impact of the health system.~   "
53706|NCT02863991|"~     ONC201 is an orally bioavailable first-in-class small molecule with demonstrated antitumor~     activity in preclinical models of difficult-to-treat solid and liquid tumors without~     imparting significant toxicity. This is a Phase 1/2 open-label study of ONC201 administered~     orally once every week in combination with dexamethasone to patients with relapsed/refractory~     multiple myeloma.~      Funding Source - FDA OOPD~   "
53707|NCT02863978|"~     Each year, 300 000 new borns are hospitalised in neonatology units in Europe. This period is~     very sensitive as newborns are exposed to a high risk of morbidity and mortality, with severe~     impact on neuro-developmental prognostic. The Rennes University Hospital was granted a~     specific funding from the European Union in the framework of the Horizon 2020 programme (Call~     PERSONALISING HEALTH AND CARE 2015-single-stage - Grant Agreement Number 689260) to develop~     the Digi-NewB project. This project aims to develop innovative non-invasive monitoring tools~     to support decision making in health. Such tools include a new generation of real time~     monitoring in neonatology using composite indices made of cardio-respiratory variables,~     movements, sounds, and clinical data. The Digi-NewB cohort aims to gather all physiological~     data relevant for the creation of the composite indices.~   "
53708|NCT02863965|"~     The aim of the study is to evaluate the diagnostic value of high definition endoscopy and~     optic enhancement in gastric neoplasia.~   "
53709|NCT02863952|"~     The aim of this study is to evaluate early post-stress EF change (∆EF) and its relation to~     the severity of myocardial ischemia and angiographic coronary disease using CZT-SPECT MPI.~   "
53710|NCT02863939|"~     The aim of this study is to test for an early post-stress cardiac output (CO) change by~     impedance cardiography and its relation to the severity and extent of myocardial ischemia and~     angiographic coronary disease in subjects undergoing exercise stress testing using a novel~     cadmium-zinc-telluride (CZT) SPECT camera.~   "
53711|NCT02863926|"~     Patients scheduled for below knee amputation (BKA) to receive bone marrow cells (cBMA)~     injected IM in the leg proximal to the BKA in the index limb to prevent ischemic wound~     complications after surgery.~   "
53712|NCT02863913|"~     This study will evaluate the safety of PD-1 knockout engineered T cells in treating~     metastatic advanced bladder cancer. Blood samples will also be collected for research~     purposes.~   "
53713|NCT02863900|"~     The main objective of our project is to further characterize the deregulation of CE~     (Cholesterol Epoxides) metabolism in different moleculars subtypes of BC (BC=Breast Cancer)~     (luminal A and B, HER2+ and triple negative). We will study not only the level of expression~     of the enzymes involved in this pathway by immuno-histochemistry, all the enzymes involved~     were identified in our preclinical work (GSTA1 (Glutathione S-Transferase A1 ), DHCR7, D8D7I,~     11βHSD2 (11β-hydroxysteroid dehydrogenase of type 2 )), but also the metabolite rates of CE~     (hydrolyses cholesterols-5,6-epoxide ), CT (into cholestane-3β, 5α, 6β triol ), DDA~     (Dendrogenin A)and OCDO (6-oxo-cholestan-3β, 5α-diol ). Our preliminary results demonstrate~     the feasibility of these dosages. We will also establish whether these deregulations are i)~     correlated with different histo-prognostic parameters (pN (N= Node), pT (T= Tumor) , EV,~     TIL…) but also clinical ii) an independent prognostic parameter of BC in terms of~     disease-free survival, metastasis-free survival and overall survival. The cohort consists of~     350 cases of BC, treated between 2009 and 2011 as well as all relevant clinical informations.~     In parallel, we will continue our preclinical work by characterizing the targets and~     mechanisms of action of OCDO. Our preliminary results indicate that OCDO is a modulator of~     the glucocorticoid receptor (GR), which could be target to inhibit this pathway. On the other~     hand, we will characterize in the same manner as in human tumors, the deregulations of the CE~     metabolism in vitro and in vivo (including xenografts in mice of human tumors, in~     collaboration with Roman-Roman S) on a representative panel of BC molecular subtypes,~     sensitive or not usually administered in clinical treatment and study the anti-tumor effect~     of various anti-OCDO therapies (therapies preventing its production such as Tam (tamoxifen)~     or DDA, inhibitor of the enzyme producing OCDO, or an inhibitor of the GR (glucocorticoid~     receptor )), alone or in combination with conventional therapies~   "
53714|NCT02863887|"~     The goal of The LEAN project intervention is to promote weight loss, healthy dietary habits,~     increased physical activity, improved blood glucose and cholesterol, and weight related~     quality of life in obese African American adults through a sustainable, technology enhanced,~     church-based program.~   "
53736|NCT02863588|"~     Ocular toxoplasmosis (OT) is a major cause of visual impairment worldwide. OT is responsible~     for 30 to 50% of posterior uveitis. It is characterized by dormant infections that may~     reactivate without known reasons, causing severe irreversible visual loss. The overall~     recurrence rate of OT in Europe is greater than 80% for patients and may range from one~     episode to 11 episodes (1% of OT) in the most extreme cases. Current treatments do not reduce~     the risk of recurrences and the risk of toxoplasmosis recurrence cannot be predicted in these~     immunocompetent patients. These clinical and biological expression changes might be related~     to an individual genetic susceptibility of each patient. The advanced analysis of the entire~     genome now possible to consider the project.~   "
53737|NCT02863575|"~     An efficacy study assessing analgesic effect of ibuprofen/caffeine in post-surgical dental~     pain.~   "
53715|NCT02863874|"~     INTRODUCTION It is estimated that over 80% of women who give vaginal birth will sustain some~     form of perineal tear and of these 60-70% will require suturing. It is of great importance~     that operators are familiar with the best suturing technique and suture material in order to~     minimize possible associated short- and long-term sequelae. There is evidence for suturing~     continuously to reduce postoperative pain and superficial dyspareunia, but the choice of~     suture-material is still debated. The function of a suture is to close the wound to minimize~     the bleeding, the risk for infection and to adapt the wound edges to promote anatomic correct~     healing. Infection results in softened wound edges, shirked sutures, pain and dehiscence.~     Delayed and/or compromised wound healing is correlated with impaired strength in the affected~     tissue. Reported frequency of infection after first and second degree tear is between 1 and~     11% where the discrepancy most likely is due to poor registration and follow-up. In 2004~     Polyglactin 910 was launched with a new antibacterial coating of Triclosan (VicrylPlus®).~     Studies suggest a correlation between the use of VicrylPlus® and a reduction of up to 30% of~     surgical site infections (SSI) compared to conventional sutures in a non-colonized wound.~      OBJEKTIVE: The primary objective is to compare infection rates and pain intensity when using~     Vicryl® versus VicrylPlus® for perineal repair after delivery. Secondly, to show if there is~     difference in insufficient wound healing or superficial/deep dyspareunia after one year~     between the two groups.~      METHODS The participants are randomly allocated to continuously suturing with either Vicryl®~     or VicrylPlus®. Sealed identical looking envelopes are prepared and placed in the delivery~     room (randomized into blocks of 50, 948 in total) containing randomization number, sutures,~     declaration of informed consent and questionnaires. The participants are instructed to fill~     in the first questionnaire after 7 days and the second questionnaire after 8 weeks post~     partum. After 8 weeks all participants are offered a routine visit to the out-patient~     clinic. After one year an internet-based survey will be sent out to the participants. In~     case of complains/signs of deficient healing after one year the woman will be offered a~     clinical control. Data will be analyzed according to intention to treat.~   "
53716|NCT02863861|"~     The purpose of this study is to compere between Propofol-Ketamine combination and~     Dexmedetomidine-Ketamine combination for sedation in upper gastrointestinal endoscopy in~     paediatric patients.~   "
53717|NCT02863848|"~     The main objective of this Pilot study was to assess the beneficial effects of a daily~     supplementation with Orafti inulin‐type fructans in 2‐5 year old constipated children The~     study is primary aimed to develop a feasibility study to assess the beneficial effect of~     inulin‐type fructans in the described population with regard to the adequate criteria for a~     larger trial. Secondary objectives are to obtain data about the feasibility of the protocol~     (as pilot study). To obtain data useful to perform sample size calculations for a big study~     designed specifically to investigate the beneficial effect of inulin‐type fructans in the~     treatment of constipated children.~      Study design and subjects: Double‐blind, randomized, placebo‐controlled parallel group trial;~     where 2‐5 year‐old constipated children received inulin‐type fructans or the same amount of~     placebo (maltodextrin) during 6 weeks. The study protocol was approved by the local Ethical~     Committees.~      Outcomes: primary outcome was stool consistency. Secondary outcomes were: stool frequency,~     gastrointestinal symptoms (abdominal pain and pain during defecation), additional medication~     required (yes/no), and colonic transit time. Stool samples at baseline, end of intervention~     and after follow‐up were obtained in order to be analysed to know about the microbiota.~     Dietary intake was also recorded at baseline, end of intervention and after follow-up.~      Principal subject inclusion criteria: Subjects were recruited if fulfil the Rome III~     constipation criteria (Mainly hard stools plus stool retention, or pain, or low frequency).~     Principal subject exclusion criteria: Age under 2 or over 5 years, diapers use, use of~     laxative during the study and 2 weeks before, use of pre‐ probiotics or antibiotics during~     the study and 4 weeks before, organic causes of defecation disorders, other metabolic or~     renal abnormalities or mental retardation, no parent's command of any local language.~   "
53718|NCT02863835|"~     Electrical impedance tomography (EIT) is non-invasive and provides functional imaging of the~     lung and it could be a useful tool to diagnose chronic lung allograft dysfunction (CLAD) and~     specially Bronchiolitis Obliterans Syndrome (BOS). Hence, for this study, the investigators~     aim to show that EIT would provide an accurate diagnostic CLAD with an ability to to~     distinguish BOS from Restrictive Allograft Syndrome (RAS) and to stage BOS accurately when~     compared to FEV1 the current gold standard. The investigators are also aiming to provide~     physiological data in lung transplant recipients with chronic rejection.~   "
53719|NCT02863822|"~     The purpose of this study is to evaluate the effectiveness of the low fermentable~     oligo-di-monosaccharides and polyols (FODMAP) diet in functional dyspepsia (FD). The~     investigators will compare education in the low FODMAP diet to a standard healthy diet for~     improving symptoms in FD.~   "
53720|NCT02863809|"~     This is a phase I/II prospective, randomized, multi-center, double-masked, vehicle-controlled~     clinical trial evaluating the safety and efficacy of corneal collagen cross-linking the~     keratoprosthesis carrier tissue in subjects who are candidates for high-risk keratoprosthesis~     implantation but because of a history of corneal melts or autoimmune diseases are not~     candidate for a traditional corneal transplant.~   "
53721|NCT02863783|"~     RATIONALE: Pancreas tumor localization makes minimally invasive surgical resection of~     pancreas tumors very challenging. Recently, an endoscopic ultrasound needle system has been~     developed which enables fiducial coils to be placed at the precise site of biopsy.~      INTERVENTION: At time of EUS guided biopsy the fine needle fiducial device will be used to~     place fiducials in the tumor. During surgery we will assess whether it improves tumor~     visualization.~      OBJECTIVES: We aim to determine the feasibility to use EUS guided fiducials placement to mark~     pancreas tumors in 20 patients and to assess whether the fiducials impact tumor visualization~     during pancreas surgery.~      STUDY POPULATION: Patients with pancreas adenocarcinoma or neuroendocrine lesions.~      STUDY ENDPOINTS: The main outcome will be to assess whether the coil may be successfully~     placed during EUS and whether they impact tumor visualization during surgery FOLLOW UP and~     ANALYSIS: Patients will be assessed at the time of EUS and surgery. This is a pilot analysis~     with the intention to assess feasibility and to gather data to power larger trials.~   "
53722|NCT02863770|"~     RATIONALE: Endoscopic Ultrasound (EUS) is the leading method to evaluate the pancreas but~     there may be difficulty characterizing small lesions, tumors which are not adenocarcinomas~     and neoplasia in the setting of pancreatitis.~      INTERVENTION: The innovation in this project will be the addition of intravenous contrast to~     standard EUS examination if the pancreas.~      PURPOSE: The aim is to determine if contrast enhances the ability of EUS to accurately~     diagnose lesions and target biopsies, and to define the quantitative features of this method.~      STUDY POPULATION:The population will include patients with pancreas cysts, masses, and~     inflammation presenting for EUS as part of standard clinical care.~      METHODOLOGY: This will be a prospective tandem trial involving conventional EUS, followed by~     EUS with contrast, followed by subsequent quantitative processing of contrast EUS imaging.~      ENDOINTS:Study endpoints will include the yield contrast EUS to evaluate pancreas cysts,~     masses, and inflammation. The impact of contrast EUS to better target the FNA of the chosen~     lesion will be assessed. Intra and interobserver variability will be assessed by comparing~     conventional EUS and contrast EUS of each case in a random order (intraobserver agreement)~     and among a group of blinded endosonographers (interobserver agreement).~   "
53723|NCT02863757|"~     The purpose of this study is to determine the disease progression in CHB/NAFLD compared with~     CHB and NAFLD including liver cirrhosis, cirrhotic complications and hepatocellular carcinoma~     (HCC).~   "
53724|NCT02863744|"~     Assessment of wound healing progression after surgery is important. Currently blunt surrogate~     markers such as probing is used. Limitation of these markers is that it represents the~     history of healing and not the ongoing activity. As hallmark of healing is collagen~     remodeling, it is of interest to study the cytokine profile that relates to wound healing.~     Such knowledge may potentially lead to new diagnostic strategies to study wound healing in a~     better way reflecting the healing phenotype. Understanding wound healing at molecular level~     provides an in depth basis to develop treatment strategies that can prevent delayed healing.2~     As recommended by Consensus Report of 10th European workshop on periodontology that, there is~     a need for more studies at cellular level to identify cytokine, chemokine, and intracellular~     signaling networks for better regenerative approaches10, the present clinical trial was~     designed.~      On account of a considerable lacunae in this area of periodontal research, this study is~     planned to assess the MMP-8 levels during the post-op healing following CAF+SCTG surgery for~     recession coverage and to better identify the mechanism involved in wound healing. This~     information can be used to prevent the normal surgical wound from altered healing experience.~   "
53725|NCT02863731|"~     Prolonged sitting is a risk factor for cardiovascular and musculoskeletal diseases, diabetes,~     several types of cancer and all-cause mortality. In combination with static and awkward~     postures, the prevalence of musculoskeletal diseases can increase further. Although the~     implementation of sit-to-stand or active workstations can help to reduce sitting time,~     improve physical activity at work and promote health benefits, it might also lead to changes~     in cognitive functions such as productivity. The purpose of this study is to evaluate the~     short-term effect of alternating working postures on cognitive performance for healthy~     people.~   "
53726|NCT02863718|"~     This is a prospective, multicenter, randomized, placebo-controlled, double-blind phase III~     study that compares the efficacy and safety of oral ibrutinib in previously untreated Binet~     stage A CLL patients without treatment indication according to iwCLL guidelines but risk of~     early disease progression.~      For event-free survival (EFS), an improvement from 24 months for untreated intermediate or~     (very) high risk CLL to 48 months for subjects treated with ibrutinib is considered~     clinically relevant. Ibrutinib / placebo is administered continuously orally until~     symptomatic disease progression, unacceptable toxicity, or voluntary treatment withdrawal,~     whichever occurs first.~   "
53727|NCT02863705|"~     The objective of this study is to evaluate the long-term efficacy and safety of COMBIGAN®~     (brimonidine tartrate/timolol malate) in patients only using COMBIGAN® (brimonidine~     tartrate/timolol malate) and also in patients who require additional IOP lowering with~     LUMIGAN® (bimatoprost) 0.01%.~   "
53728|NCT02863692|"~     Long term follow-up of patients with chronic lymphocytic leukemia (CLL), B-prolymphocytic~     leukemia (B-PLL), T-cell prolymphocytic leukemia (T-PLL), Small lymphocytic lymphoma (SLL),~     T/Natural Killer large granular lymphocyte leukemia (T or NK-LGL), Hairy cell leukemia (HCL)~     and Richter's transformation~   "
53729|NCT02863679|"~     This study was taken out to assess the postoperative analgesic efficacy of tetracaine~     hydrochloride gel in patients with intrauterine adhesion treating with intrauterine~     balloon.Participates were assigned into two groups by randomly-tetracaine hydrochloride gel~     group and control group.~   "
53730|NCT02863666|"~     Prospective observational clinical study to verify an algorithm used to predict~     cardiopulmonary events in patients presenting to the emergency department.~   "
53731|NCT02863653|"~     Objective: To evaluate what factors contribute to social participation restrictions in~     subjects with Rheumatoid Arthritis (RA), considering the model International Classification~     of Functioning (ICF).~      Methods: Cross-sectional study with 81 individuals with Rheumatoid Arthritis, using~     instruments to measure two constructs of component social participation.~   "
53732|NCT02863640|"~     Age related macular degeneration (ARMD) is a major and irreversible cause of blindness among~     the elderly. The sub-retinal space, located between the retinal pigmentary epithelium (RPE)~     and the external segments of the retinal photoreceptors, plays a crucial role in this~     pathology. A recent epidemiologic study in the US, unpublished yet, has shown that patients~     treated with the L-DOPA, developed only later an ARMD when compared to the untreated~     patients.~      The L-Dopa is an endogenous ligand of the GPR43 receptor, located on the RPE's cell's apical~     pole.~      This receptor, via several intracellular mechanisms, regulates the cell's exosomal and~     endosomal pathways: it would appear that the L-DOPA, by stimulating this receptor, decreases~     significantly the RPE's exosome release.~      The contents of the exosomes is still uncertain, however in addition to their signalization~     role, it seems they transport pro-inflammatory components, possibly helping the cellular~     recruitment due to the mononuclear phagocytic systems, particularly toxic for the~     photoreceptors.~      The aim of this study is to validate the hypothesis stating that he L-DOPA would play a~     protective role against age related macular degeneration.~   "
53733|NCT02863627|"~     This study will evaluate the course of care of newborns, to understand why some newborns have~     improper care pathways, particularly as regards the first medical consultation at the exit of~     motherhood. It is also to organize a better quality care network to hospital discharge to~     avoid unnecessary use of pediatric emergencies, which represents a real public health~     problem.~   "
53734|NCT02863614|"~     The aim of this study is to evaluate whether Ibuprofen alone or combined with lorazepam~     reduce the pain associated with endometrial scratching/injury.~   "
53735|NCT02863601|"~     The primary purpose of this study is to determine whether buprenorphine and metabolite~     exposure (reflected as the dose-adjusted plasma concentration x time curve [AUC]) differs~     during pregnancy and between pregnancy and the postpartum state.The study will define the~     pharmacokinetics of buprenorphine and determine if there is a better way to gauge dosing~     based on objective, physiological parameters of satiety. The study will define neonatal~     exposure to buprenorphine through breast milk.~   "
53738|NCT02863562|"~     Soccer is a sport that attracts many participants and leads to a substantial number of~     injuries, especially of the ankle. Enhancement of functional joint stability by kinesio~     taping proprioceptive training may be important both in prevention and rehabilitation of~     ankle injuries. The main aim of this study was to determine the effect of kinesio taping and~     proprioceptive exercises on parameters related to ankle stability, such as the injury~     incidence, pain, static or dynamic stability and flexibility, in amateur soccer players~     training 3 times a week.~   "
53745|NCT02863471|"~     In patients with peritoneal metastases of colorectal cancer could be a radical removal of all~     tumor foci a significantly improved survival compared to a sole systemic chemotherapy are~     additionally achieved by a hyperthermic intraoperative chemotherapy (HIPEC).~   "
53746|NCT02863458|"~     The study aims to comprehensively analyze data from a large and unselected older AML~     population in the US, both treated and untreated. These data will widen understanding of~     treatment decisions for the older Acute Myeloid Leukemia (AML) population. Through use of the~     SEER-Medicare Registry, the effectiveness and impact of HMA treatments as well as the~     effectiveness of lenalidomide will be studied.~   "
53747|NCT02863445|"~     Obese women are significantly more likely than their normal BMI counterparts to experience~     failure of orally-dosed emergency contraceptives. The PI's preliminary data provides evidence~     for testing a dose escalation strategy in an effort to provide improved efficacy from~     orally-dosed emergency contraceptives in obese women. The overall project will be focused on~     both levonorgestrel (LNG) - and ulipristal acetate-containing emergency contraception but~     this protocol registration is for the LNG aspect of the study procedures.~   "
53748|NCT02863419|"~     This trial is conducted globally. The aim of this trial is to investigate efficacy and safety~     of oral Semaglutide versus Liraglutide and versus Placebo in Subjects with Type 2 Diabetes~     Mellitus.~   "
53749|NCT02863406|"~     Comparison of dusting rate of bronchoalveolar lavage in healthy volunteers and patients~     suffering from sarcoidosis.~      Blind analysis of bronchoalveolar lavage with Optical Microscopy, Transmission Electron~     Microscopy and MicroAnalysis.~      For patients, comparison of bronchoalveolar lavage, pathological examination of biopsies~     (Optical Microscopy, Transmission Electron Microscopy and MicroAnalysis) and specific~     Professional and environmental questionnary.~      Healthy volunteers matched with patients regarding to age (every 10 years), sex and tobacco~     consumption (non-smoking, smoking less than 5 pack-year, smoking between 5 and 10 pack-year,~     smoking more than 10 pack-year)~   "
53750|NCT02863393|"~     The non-alcoholic fatty liver disease is increasing and associated with obesity, diabetes and~     hyperlipidemia in recent years. Aerobic exercise indeed reduces adipose, hepatic insulin~     resistance and hepatic fat. However, diaphragmatic breathing improves cardiopulmonary~     function, the oxygen content of the body and therefore reduces inflammation of cells. The aim~     of this study is to ameliorate hepatic inflammation by using diaphragmatic breathing~     exercises instead of aerobic exercise to reduce the fat in liver inflammation.~   "
53751|NCT02863380|"~     The investigators hypothesize that personalizing the rTMS targets using functional MRI will~     increase its efficacy. The most dysfunctional regions or the most dysfunctional network will~     be stimulated homogeneously. Individualized rTMS will be compared to traditional rTMS~     procedure and to trans-cranial direct current stimulation (tDCS) in a randomized cross-over~     trial.~      In this pilot study the primary outcome measure will be the correction of the MRI anomalies.~     Symptoms reduction and the proportion of remitters will be secondary outcome measurements.~   "
53752|NCT02863367|"~     Evaluate the efficacy and safety of Apatinib (500mg/d) with gemcitabine(1000mg/m2) in~     advanced metastatic pancreatic cancer.~   "
53753|NCT02863354|"~     The RECOVERY trial will assess the safety and tolerability of 2 mg intravitreal aflibercept~     injections (IAI) given monthly (Q4WK) or every 12 weeks (Q12WK) for the treatment of retinal~     capillary non-perfusion (RNP) associated with proliferative diabetic retinopathy (PDR).~        -  Assess the safety and tolerability of IAI for the treatment of proliferative diabetic~          retinopathy by evaluating the incidence and severity of ocular and systemic adverse~          events through week 52~        -  Change in area of retinal capillary non-perfusion, as assessed by central reading~          center, from baseline through week 52~   "
53754|NCT02863341|"~     This is a multi-centre study in Singapore nursing homes, investigating the factors that~     affecting deprescribing, and if a team-care based deprescribing standard practice gives~     superior health and pharmacoeconomic outcomes over current medication review practice.~   "
53755|NCT02863328|"~     This trial is conducted globally. The aim of this trial is to investigate Efficacy and Safety~     of Oral Semaglutide versus Empagliflozin in Subjects with Type 2 Diabetes Mellitus.~   "
53756|NCT02863315|"~     The purpose of this study is to evaluate the analgesic effect of transcutaneous spinal direct~     current stimulation (tsDCS) applied on spinal cord in patients with spinal cord injury who~     have chronic neuropathic pain.~   "
53757|NCT02863302|"~     The aim of this study is to test a complementary therapy intervention (reflexology) that will~     assist in improving quality of life (QOL) for patients undergoing chemotherapy for acute~     myeloid leukemia. within the context of conventional medical care. Quality of life will be~     assessed via intermediate indicators: 1) physical indicators (greater physical functioning,~     lower presence of symptoms) 2) emotional indicators (greater spirituality, lower anxiety, and~     lower depressive symptomology); by a specific questionnaire. 3) chemotherapy side effects~     associated with the digestive system.~   "
53758|NCT02863289|"~     To date, the clinical benefits and harms of surgical intervention in proximal humerus~     fractures in children remain debatable. The practical question raised by orthopaedic surgeons~     is: for children and adolescent, are the clinical and radiological outcomes after~     non-operative management as equivalent as after surgical management for proximal humerus~     fractures? The investigators' hypothesis is that due to the healing potential of the proximal~     humerus, the outcome from this fracture is usually excellent.~      The investigators have applied for Caldicott approval to identify a cohort of eligible~     patient from NHS Tayside's radiography service. With the community health index (CHI) number,~     the investigators can review all shoulder X-rays performed in children and adolescents, aged~     from 10 to 18-year-old in NHS Tayside, from 2008 to 2015. The Caldicott approval also allowed~     the investigators to obtain clinical communication from the Clinical Portal (electronic~     summary healthcare records). The investigators will then conduct mail questionnaires, based~     on the Upper Extremities Functional Index (UEFI). The investigators will send out invitation~     letter with participation information and the UEFI questionnaires to the eligible patients;~     with return postages. If no response within 2 weeks, the investigators will send out 1~     further reminder. If no further response, the patient will be excluded from the study.~   "
53845|NCT02862158|"~     This is a single center, prospective study to evaluate the efficacy and reproducibility of~     frequency doubling technology (FDT)-based visual field devices compared to conventional~     Humphrey Visual Field (HVF) perimetry. The investigators plan to enroll 500 patients in this~     study.~   "
53759|NCT02863276|"~     Background Surgical injury provokes a stress response. These pathways mediated by stress~     hormones and cytokines cause a catabolic state. The loss of body cell mass may result in~     prolonged convalescence and increased morbidity. Protein catabolism after colorectal surgery~     is even more increased in patients with type 2 diabetes mellitus. Epidural blockade, by~     reducing the intensity of the catabolic response, improves substrate utilization after~     surgery in non-diabetic patients. This effect is even more pronounced in diabetic patients~     receiving amino acids.~      The aim of the study is to explore the effect of two different protocols to manage blood~     glucose control on glucose and protein metabolism in patients with type 2 diabetes mellitus~     undergoing colon surgery and receiving epidural analgesia and perioperative feeding with~     amino acids. The following hypotheses are tested:~        1. Tight perioperative blood glucose control with intensified insulin therapy compared to~          standard blood glucose control in presence of general anesthesia with epidural analgesia~          and amino acid infusion would reduce endogenous glucose production and leucine~          oxidation.~        2. Tight blood glucose control and perioperative infusion of amino acids induce a more~          positive protein balance compared to standard blood glucose control by better oxidative~          glucose utilization and redirecting amino acids from oxidative to synthetic pathways.~      Material and Methods A total of 20 patients with diabetes mellitus type 2 undergoing elective~     colorectal surgery will be admitted to the study. Patients will be randomly assigned to~     receive standard blood glucose control (blood glucose target <10 mmol*l-1; control group;~     cytotoxic T lymphocyte (CTL) group, n=8) or to receive tight blood glucose control with~     intensified insulin therapy (blood glucose target<6 mmol*l-1; intensified insulin group; II~     group, n=8). All patients will receive general anesthesia and an epidural catheter for~     perioperative analgesia. During surgery (intraoperative state) and immediately after surgery~     (postoperative state) when receiving an amino acid infusion protein and glucose kinetics will~     be assessed using a stable isotope technique with L-[1-13C]leucine and [6,6-2H2]glucose and~     circulating concentrations of glucose, glucagon, insulin and cortisol will be measured. The~     primary endpoints of the study will be protein balance. Sample size is set to ensure at least~     80% power at a significance level of 0.05.~   "
53760|NCT02863263|"~     This study aims to exploratively assess the efficacy and safety of hydrophilic polyurethane~     foam dressing (MedifoamⓇ or BetafoamⓇ) in pressure ulcer specifically. The target enrolment~     is 20 patients, with 10 patients per arm.~   "
53761|NCT02863250|"~     Severe and unstopped blood loss can occur for a number of different reasons including after a~     serious injury, delivery of a baby and following other medical and surgical emergencies. The~     investigators understanding of how to best treat people with serious bleeding is still~     incomplete, with many questions remaining. These include questions regarding how many people~     have serious bleeding events, what happens to them and the best way to treat them.~      The Massive Transfusion Registry (MTR) is a register of patients who have experienced major~     blood loss that required a massive transfusion in any clinical setting.~      The MTR uses electronic data extraction and data linkage methodologies. Pre-existing clinical~     data from hospital data sources, including Laboratory Information Systems (for transfusion~     history and laboratory results) and Health Information Services databases (for Patient~     demographics and admission data), are electronically extracted by staff employed at the~     participating hospitals. The data is then sent to the MTR Research Team, located at Monash~     University, where it is then linked, analysed and stored.~      The establishment of a Massive Transfusion Registry will be a unique and important resource~     for clinicians in Australia, New Zealand and internationally, for Blood Services and for the~     broader community. It will provide valuable observational data regarding the types and~     frequency of conditions associated with critical bleeding requiring massive transfusion, the~     use of blood component therapy (i.e. ratios and quantities of different types of red cell to~     non- red cell components) and patient outcomes.~   "
53762|NCT02863237|"~     Brian injured patients are predisposed to various complications related to mechanical~     ventilation. Appropriate decision making of the weaning is crucial and validated predictive~     parameters are desirable. In present study, the investigators aim to a) validate the~     electrical activity of diaphragm (EAdi) derived parameters, and b) evaluate the traditional~     predictive parameters in weaning prediction in brain injured patients.~   "
53763|NCT02863224|"~     Globally primary open angle glaucoma (POAG) affects over 60 million people. The exact~     pathogenesis of POAG is poorly understood. A significant risk factor for glaucoma is~     advancing age. The rate of ageing is not the same in all age matched individuals. The concept~     of accelerated ageing suggests that the presence of a number of specific genetic,~     environmental or systemic risk factors may cumulate to accelerate the ageing process in some~     individuals and lead to the development of age-related disease. Understanding the factors~     that influence accelerated ageing is vital.~      Advanced glycation end products (AGEs) are a complex group of compounds that are naturally~     formed. They accumulate gradually with age in cells, tissues and blood vessels throughout the~     body where they adversely affect structure and function. Circulating AGE levels can be~     influenced by oxidative stress levels and dietary intake. Recent research has found that~     sustained exposure to high levels of circulating AGEs could be a major factor in the~     development of a number of chronic age-related degenerative disorders, including POAG.~      To date there have been few clinical studies that have been able to non-invasively explore~     the association between AGE levels and the development and progression of glaucomatous optic~     neuropathy (GON), or to explore the possible contribution that oxidative stress and dietary~     intake make to total tissue AGE levels in such patients. Furthermore little is understood~     about the relationship between AGE levels and retinal vascular function, a parameter known to~     be altered in GON that also could be influenced by AGE levels.~      The proposed study will aim to evaluate whether tissue-bound AGE levels are associated with~     parameters of retinal vascular function, oxidative stress, dietary intake and the presence of~     GON. Establishing this association could increase our understanding of the pathogenesis of~     GON and allow a new biomarker for accelerated ocular ageing to be realised~   "
53764|NCT02863211|"~     Efforts to identify individuals at a higher risk for adverse cardiovascular outcomes focus on~     traditional risk factors, such as age, gender, smoking status, blood pressure, and~     cholesterol; however, this approach does not directly assess cardiovascular function and~     underestimates the risk of experiencing adverse cardiovascular outcomes in women. This~     prospective, observational trial will examine the ability of the Heart Attack Prevention~     Program for You (HAPPY Hearts) screening protocol, a series of non-invasive procedures to~     identify middle-aged and older women who are at elevated risk for experiencing an adverse~     cardiovascular event in the five-year period after screening. The predictive value of the~     HAPPY Hearts protocol will also be compared to the Framingham Risk Score to determine if one~     method has better sensitivity for estimating risk for an adverse cardiovascular outcome.~   "
53765|NCT02863198|"~     One hundred and twenty women with unexplained infertility were included in the study. Divided~     randomly into two groups:~      Group I: (60 patients): (control group)~      Group II (60 patients): (study group)~      All the patients received (CC) and human menopausal gonadotropin. On day 5 of the cycle,~     Doppler examination was performed to all patients. Also on day 5, but only for group (II)~     patients, local endometrial injury was performed. Doppler studies was repeated, for all our~     patients, on the same day of prescribing human chorionic gonadotropin~   "
53778|NCT02863029|"~     New studies are revealing how a high-fat diet could be making the cells of the intestinal~     lining more likely to become cancerous. The investigators would like to study how obesity~     influences growth of intestinal stem cells, which could then trigger intestinal tumors.~      The investigators are proposing a Pilot Study of 20 subjects (comprised of 10 participants~     from each of two different BMI categories: 20-25 and 35 & above), who will be asked to~     provide blood, stool, & urine samples, undergo a flexible sigmoidoscopy, and complete food~     frequency questionnaires~   "
98357|NCT02279797|"~     The study evaluates the knowledge, attitude and practice about bone marrow donation among~     medical students and medical staff.~   "
53766|NCT02863185|"~     Patients with chronic kidney disease (CKD) are high risk for death and cardiac disease is the~     major cause of death. CKD patients commonly have traditional risk factors for coronary artery~     disease, such as age, gender, hypertension, cigarette smoking, and dyslipidemia. Previous~     studies have reported that reducing cholesterol levels is associated with reducing morbidity~     and mortality from atherosclerosis. In particular, pharmacologic treatment using statin has~     been decreased the risk of adverse cardiovascular events in CKD population. Therefore,~     guidelines recommended the use of statin in CKD patients. On the other hands, niacin or~     fibrates is not recommended concomitantly with statins in patients with CKD because of~     increased risk of adverse events. In addition, recent study has reported that there was no~     incremental clinical benefit from the addition of niacin to statin therapy, in further~     decreasing the incidence of major cardiac events.~      Supplementation with omega-3 fatty acid (FA) lowers the risk of cardiovascular death in~     patients with myocardial infarction. This cardioprotective effect of omega-3 FA can be~     explained by anti-inflammatory, anti-oxidative, or anti-thrombic effects. In addition,~     omega-3 FA modulates cell membrane receptors and affects signal transduction and eicosanoid~     metabolism. The erythrocyte membrane content of FA has been shown to correlated with the FA~     content of the myocardium. The risk of cardiovascular disease is significantly reduced in~     patients with high omega-3 FA, such as eicosapentanoic acid or docosahexaenoic acid (DHA), in~     the erythrocyte membrane. In contrast, high levels of erythrocyte membrane total trans-FA,~     trans-oleic acid, and arachidonic acid (AA) are associated with an increased risk of~     cardiovascular disease. Erythrocyte membrane monounsaturated FA (MUFA) content, including~     oleic acid, is significantly higher in patients with acute coronary syndrome than control~     subjects. The erythrocyte membrane oleic acid content was also higher in dialysis patients~     who have high risks of cardiovascular disease compared to control subjects. Therefore, the~     modification of erythrocyte membrane FA content is very important with respect to~     cardiovascular disease. In a previous study, erythrocyte membrane omega-3 FA was shown to be~     increased and the MUFA content was decreased after omega-3 FA supplementation in HD patients.~     However, there are no reports about the effect of statin on the erythrocyte membrane FA~     composition in CKD. Recent study has reported that those with pitavastatin 4mg were decreased~     DHA to AA ratio, but those with pravastatin 20 mg were not change the DHA to AA ratio in~     patient with CAD. Statin may have important role on the modulation of erythrocyte membrane~     FA. In this study, the investigators hypothesized that pitavastatin supplementation can~     modify erythrocyte membrane FA content, including MUFA and oleic acid, in CKD patients. In~     addition, the investigators evaluated the effect of pitavastatin on adiponectin and glucose~     level in CKD patients.~   "
53767|NCT02863172|"~     Objectives:~        1. To examine the variations in clinical features, survival outcomes, family history, and~          health behavior among proband patients who are known or suspected to have a hereditary~          colorectal cancer syndrome~        2. To compare the clinical features, survival outcomes, and health behavior of the proband~          vs. his/her family members who may or may not be affected by the hereditary colorectal~          cancer syndrome~        3. To explore for correlations between germline genetic variations in both the probands and~          family members with observed variations in the overall disease phenotype across probands~          and kindreds, within a given syndrome. Disease phenotype is defined to include: (1)~          clinicopathologic features including patient demographics and oncologic outcomes; (2)~          clinical manifestations of disease including the timing, spectrum and severity of CRC~          and extracolonic cancers. Genetic variations may include the specific codon mutated, the~          type of mutation and sequence alteration (e.g. nonsence, missence etc), chromosomal/gene~          copy number changes, and gene polymorphisms.~        4. To explore for correlations between germline genetic variations in both the probands and~          family members with observed variations in somatic CRC tumor biology, including tumor~          pathology and other tumor molecular markers~   "
53768|NCT02863159|"~     The objective of this study is to evaluate the uncorrected binocular distance, intermediate,~     and near visual acuities, and assess patient's spectacle independence and satisfaction in~     individuals undergoing bilateral cataract extraction that have received two different arms of~     near add design IOLs of the same diffractive multifocal model.~   "
53769|NCT02863146|"~     HALACAP-1406 is a prospective single-centre non-interventional study assessing the~     refrigerant helmet use as medical device to prevent alopecia induced by eribulin (Halaven®)~     in the conditions of use specified in its marketing authorization. Eribulin will be used~     alone for the treatment of the patients having a locally advanced or metastatic breast cancer~     which have progressed after at least 1 chemotherapy regimen for their advanced stage.~   "
53770|NCT02863133|"~     The study is a prospective, multicenter, multinational study to assess the safety and~     performance of the Easyx (trade name) Antia Liquid Embolic during embolization of~     intracranial malformations and fistulas. The clinical trial will include patients already~     scheduled for neuroradiological interventions. It is estimated that up to 8 sites will be~     required to collect the safety and performance data of the study material. Up to 65 patients~     will be enrolled in the study to achieve 53 evaluable patients. Each study centre will be~     required to treat 5 patients with a Dural arteriovenous fistula - DAVF before they can treat~     brain arteriovenous malformations - AVMs or brain tumours. Only experienced neuroradiologists~     will be invited to participate in this study.~   "
53771|NCT02863120|"~     This study is being done to evaluate the outcomes of patients undergoing total knee~     replacement with two different methods of local pain control:shots of liposomal bupivacaine,~     a long acting anesthetic, directly into the knee during surgery or anesthetic delivered~     continuously to the adductor canal to provide long term pain relief. The goal is to try to~     find a standard protocol that provides the greatest pain relief for patients undergoing total~     knee replacement.~   "
53772|NCT02863107|"~     The goal of this laboratory research study is to learn more about genetic factors that may~     influence the risk for developing colorectal cancer at a young age.~   "
53773|NCT02863094|"~     To investigate the treatment effect of continuous transcranial magnetic stimulation on~     schizophrenia patients with auditory hallucinations, and the underlying neural mechanism by~     functional MRI~   "
53774|NCT02863081|"~     Select Specialty, a national network of more than 100 LTACHs across the United States, has~     expressed the desire to adopt the ABCDEF bundle as a standard of care for its patients. As~     part of this initiative, Select first plans to conduct an ABCDEF bundle quality improvement~     project in one of its local hospitals. The overall purpose of this before-after study is to~     study prospectively the process and effects of implementing the ABCDEF bundle into the~     everyday care of patients requiring prolonged mechanical ventilation in the LTACH setting.~   "
53775|NCT02863068|"~     The investigators propose a Phase II study, prospective and placebo controlled, of a topical~     cream containing sodium nitrite compared to the current standard of care. Sodium nitrite is a~     local donor of nitric oxide, which is known to improve blood flow and decrease bacterial load~     in the ulcer bed. The primary objectives are to evaluate the safety of topical sodium nitrite~     cream treatment in patients with sickle cell disease and chronic leg ulcers and to determine~     its effectiveness in accelerating the healing process and decreasing the pain associated with~     ulceration.~      Potential benefit will be a durable resolution or improvement of the leg ulcer and its~     associated pain. Possible side effects include decreased blood pressure and~     methemoglobinemia, secondary to sodium nitrite absorption through the ulcerated skin. Funding~     source FDA OOPD.~   "
53776|NCT02863055|"~     This is a multicenter, randomized, 1:1, double blinded phase II trial. Patients with~     unresectable malignant pleural mesothelioma (MPM) will be randomized between arm A:~     nintedanib and arm B:placebo~   "
53779|NCT02863016|"~     The aim of this study was to evaluate the effect and timing of action on the inflammatory~     state of a acetate-free containing citrate concentrate (Cit-, 1 mM Citrate) in online~     postidultion HDF with high volumes compared to traditional concentrated (Ac-, 3 mM of acetate~     ) in the medium term. In addition, the study will evaluate other parameters of efficiency~     dialysis, cardiovascular stability, the safety of the concentrate with regard to bone~     metabolism and vessel calcification in the medium term.~   "
53780|NCT02863003|"~     Retrospective and prospective cohort of patients with germ cell tumor in treatment.~   "
53781|NCT02862990|"~     To evaluate the attitude of pre menopausal women with breast cancer faced with the risk of~     loss of fertility caused by chemotherapy using EORTC's Fertility Questionnaire.~   "
53782|NCT02862977|"~     The purpose of this study is to evaluate the safety and efficacy of an association with one~     anti-inflammatory and one muscle relaxant plus caffeine compared to one anti-inflammatory~     plus caffeine in the treatment of osteomuscular pain in adults.~   "
53783|NCT02862964|"~     Currently, at UVA, handheld ultrasound devices (like those used to view an unborn baby) are~     only two dimensional. The Accuro is a three dimensional handheld ultrasound device. This~     device uses sound waves to create pictures of the spine in three dimensions. This may allow~     the physician to view the spine in more detail for procedures such as spinal anesthesia and~     other diagnostic procedures.~      The investigators aim to assess the benefit of using the Accuro versus traditional landmark~     palpation technique to determine accurate spinal level for procedures. Patients who undergo~     interventional pain procedure per standard care under fluoroscopy and require the presence of~     an anesthesia provider at the UVA Pain Management Clinic will be approached for enrollment.~      Anesthesia Providers will first identify the L4/L5 space using the traditional technique of~     palpating the iliac crests to estimate spinal level, which will be marked with a single dot~     from a marking pen. The provider will then use the Accuro 3000 to identify the L4/L5~     interspace and mark this point with two dots. Participants will then be taken into the~     fluoroscopy suite for their scheduled procedure. Since the skin marks will not show up on~     fluoroscopy, and metal instrument will be laid on the skin at the interspace or interspaces~     that were marked using the palpation and Accuro techniques. The anesthesiology attending~     provider in the fluoroscopy suite will then confirm the true interspace position of these~     marks under fluoroscopy. It will then be recorded how many spaces off the palpation and~     Accuro techniques are from the intended L4/L5 level.~   "
53784|NCT02862951|"~     The specific aim is to attempt to quantify the amount and efficiency of sleep that~     parturients receive after placement of labor epidural analgesia.~   "
53785|NCT02862938|"~     This is a randomized, sham controlled, masked clinical trial of 60 study participants with~     glaucoma. Participants with a qualifying study eye will be randomized after screening and~     baseline evaluations to receive the NT-501 encapsulated cell therapy (ECT) implant or a sham~     surgery (control arm), and no explant will be required.~      An examination for safety will occur one day and one week following implant and periodically~     thereafter for 24 months post-implant. Based on the primary analysis of data at 6 months,~     patients in the control arm may be offered the NT-501 ECT implant at the 12 month time point.~   "
53786|NCT02862925|"~     This study is a pilot study taking place in Moshi, Tanzania at the Kilimanjaro Christian~     Medical Centre (KCMC). The study aims to introduce fetal scalp stimulation into the~     intermittent auscultation protocols at KCMC, and to validate whether or not a handheld~     Doppler device can perform the fetal scalp stimulation test accurately.~   "
53787|NCT02862912|"~     This study aims to determine whether or not spinal anesthesia with the local anesthetic drug,~     chloroprocaine, wears off faster than the local anesthetic drug, bupivacaine, and results in~     faster discharge from the post-anesthesia care unit after surgery.~   "
53788|NCT02862899|"~     The investigator will study the possibility of in situ heating of the liquid containing the~     chemotherapy, so as to avoid the need for an external pumping system with its complexity, and~     its associated risks and costs.~      The use of a heating cable (prototype hereinafter called Thermowire, made by the company EFS,~     which is in charge of its development) was patented and tested in pigs in two studies that~     included 15 animals altogether (in 7 of which the heating cable was used). The aim of the~     first study was the purely safety aspects, while the efficacy to obtain hyperthermia, the~     quality and the homogeneity of the hyperthermia and its effect on the tissue penetration of~     the chemotherapy were evaluated in a second study. The results obtained justify transfer to~     use in humans in the context of a clinical trial so as to obtain CE certification.~   "
53789|NCT02862886|"~     CHRONOLOGICAL DESCRIPTION OF THE STUDY~        1. Information provided to study participants~        2. Collection of written informed consent~        3. Harvesting of myometrial biopsies~        4. Creation of tissue explants using myometrial biopsies~        5. Stimulation of the explants with LPS~        6. Study of the effect of SAR150640 (beta3-adrenergic agonist) on LPS-induced oxidative~          stress Moreover, demonstrating the ability of beta3-adrenergic receptor agonists to~          prevent the appearance of oxidative stress and its consequences on tissues, as a~          complement to previous studies, is an additional argument for the clinical development~          of this class of pharmaceuticals in the management of threatened premature delivery and~          labour induction.~   "
53790|NCT02862873|"~     The intravenous injection of 8mg of ondansetron (a serotonin type 3 receptor antagonist)~     before spinal anaesthesia for caesarean section, leads to a smaller reduction in systolic~     arterial pressure (SAP).~      The expected results are a decrease in the frequency and severity of hypotension, thus~     leading to improved comfort for the mother and decreased maternal and foetal morbidity.~     Indeed, episodes of hypotension are responsible for impaired foeto-placental circulation,~     with sometimes severe consequences for neonates.~      It has been established that episodes of hypotension alter foetal pH. Investigators therefore~     hope to see a smaller reduction in SAP in the ondansetron group, and show a benefit for the~     infant.~      One of the objectives of this study is also to observe a decrease in the quantity of~     vasopressors used and thus to avoid the adverse effects of their use in high doses.~      The expected results are thus an improvement in haemodynamic stability during spinal~     anaesthesia for caesarean section.~      The originality of this project lies in the use of a CNAP monitor (Continuous Non-invasive~     Arterial Pressure) as the collection of haemodynamic data will allow greater precision with~     the continuous measurement of AP, as well as a study of maternal cardiac output.~   "
53791|NCT02862860|"~     As glycaemic variability on the one hand and hypoglycaemia on the other are associated with~     oxidative stress and inflammation, they are likely, in type-1 diabetic patients, to affect~     the oxidation of lipoproteins and HDL function, by altering their anti-atherogenic~     properties.~      The aim of this study is thus to determine, in patients with Type 1 Diabetic (T1D) who will~     wear a glycaemic Holter for 1 week, the glycaemia parameters (mean glycaemia, duration of~     hypoglycaemia, duration of hyperglycaemia, mean amplitude of glycaemic excursions) associated~     with proatherogenic alterations in lipoproteins, in particular:~        -  LDL oxidation~        -  HDL oxidation and alterations of HDL function (anti-inflammatory capacity, antioxidant~          capacity)~   "
53792|NCT02862847|"~     Cosavirus and Salivirus are two new genera of Picornaviridae and are responsible for acute~     diarrhoea. They have been identified in the pathological stools of infants and~     immuno-compromised subjects on every continent with prevalences ranging from 2.8% to 8.8%~     depending on the virus, the cohort and the country studied.~      To date, no study on these two viruses has been conducted in France to evaluate the~     circulation and the pathogenicity of these viruses in subjects with diarrhoea.~      The aim of this study is thus to:~        -  show that these viruses are in circulation in France in infants younger than 5 years old~          and that the proportions are similar to those reported in the literature.~        -  confirm the relationship between the diarrhoea and the infection with these viruses.~   "
53793|NCT02862834|"~     In the context of this study, the investigators wish to take advantage of high-throughput~     genetic techniques (microarray and high-throughput exome sequencing) to identify new genes~     implicated in syndromic poikiloderma so as to improve the diagnostic decision tree in these~     syndromes, opportunities for genetic counselling for patients and their families and the~     follow-up of patients, notably with regard to the risk of tumours.~      This study will make it possible to identify new genes implicated in syndromic poikiloderma~     and improve the diagnostic strategy proposed to patients with these syndromes, and to propose~     to patients a confirmed diagnosis, appropriate follow-up, notably with regard to the risk of~     tumours, genetic counselling to families and eventually an antenatal diagnosis to couples who~     would like to have one for future pregnancies.~      The identification of new genetic causes of syndromic poikiloderma will also make it possible~     to complete the current classification of these syndromes~   "
53794|NCT02862821|"~     The purpose of this study is to identify alterations of motivational processes related to~     decision making in uncertainty condition associated with gambling addiction: by studying the~     dynamics between brain systems involved in decision making and motivation.~   "
53795|NCT02862808|"~     Evaluation of diagnostic whole exome sequencing in patients with syndromic or isolated severe~     intellectual disability without a molecular diagnostic, with suspected autosomal recessive~     inheritance, allowing accurate genetic counseling in this high risk of recurrence group of~     diseases~   "
53796|NCT02862795|"~     Human papillomavirus (HPV) are involved in up to 95 % of anal canal neoplastic lesions.~     Little is known about HPV carriage in anal canal previous to cancer occurrence in the~     population and pre-neoplastic lesions, and their risk factors. PAPILLAN is a prospective~     study that aims to study HPV infection (HPV low grade and high grade genotypes) prevalence in~     anal canal in a population non selected by its HIV status. In that purpose patients are~     prospectively recruited in a french university hospital gastroenterology unit and anal smears~     are collected during a colonoscopy with cytobrush.~   "
53797|NCT02862782|"~     Background~      The trigger for the final maturation of the ovum by providing integration of Human Chorionic~     Gonadotropin (hCG) and Gonadotropin - releasing hormone (GnRH) agonist was first introduced~     long ago, but clinically not accepted until the advent of GnRH antagonist protocol in IVF~     treatment.~      In a recently published work which compared two types of ovulation induction (standard dose~     of hcg and in combination of GnRH agonist) in women with normal ovarian response, there was a~     statistically significant increase in the rates of implantation, clinical pregnancies and~     live births rates by providing integration of hCG and GnRH agonist.~      To conclude, providing GnRH agonist in combination of hCF in standard dose is today an~     accepted treatment for final maturation of the ovums.~      OBJECTIVE~      The investigators objective is to investigate whether providing integrated treatment of~     Gonadotropin - releasing hormone (GnRH) Agonist and human Chorionic Gonadotropin (hCG) to~     final maturation of the ovum can improve the quality of the embryos, clinical pregnancies and~     live births rates in women treated with GnRH Antagonist protocol.~      The main objective is to compare between two existing treatments.~   "
53798|NCT02862769|"~     The aim of this study is to evaluate the impact of intravenous lidocaine on acute and chronic~     post surgical pain on patients undergoing video assisted thoracoscopic surgery(VATS). The~     investigators believe that systemic administration of lidocaine during the perioperative~     period would be effective in preventing chronic pain post VATS. In addition to chronic pain~     the investigators believe it will reduce acute postoperative pain as well as each patients~     total opioid requirement.The investigators believe that this will have a significant impact~     on the care of patients presenting for VATS.~   "
53799|NCT02862756|"~     Endovascular treatment of ruptured and unruptured intracranial aneurysms presents~     complications, mainly the thrombo-embolic complication. No specific studies have been~     conducted to study factors associated with the occurrence of thromboembolic complications~     (symptomatic or not) post endovascular treatment of intracranial aneurysms.~   "
53800|NCT02862743|"~     Analysis of somatic mutations in tumors is currently indicated for daily practice in all~     metastatic melanoma. Actually, this research is limited to the mutation of three biomarkers~     validated by the l'Institut National du CAncer (INCA): BRAF, NRAS and CKIT. Moreover, in some~     cases it requires invasive biopsies.~      In this context, molecular characterization of a tumor material flowing (circulating tumor~     DNA and / or circulating tumor cells) could afford to benefit patients in the best conditions~     of current targeted therapies and future.~   "
53809|NCT02862626|"~     The incidence of type one diabetes is still rising, especially in children under 5 years old.~     Mothers often are the primary caregivers of these children. To take care of a young child~     with diabetes is a great responsibility and mothers must be constantly vigilant. This study~     aims to assess the psychological state of these mothers (in term of depression, anxiety,~     stress, coping, fear of hypoglycemia) and factors which influence this state.~   "
70620|NCT02642601|"~     the aim of the study is to assess the role of indomethacin in cases of difficult embryo~     transfer in intracytoplasmic sperm injection cycles.~   "
53801|NCT02862730|"~     Closed-loop systems are an emerging technology that automate hormone delivery. They are~     quickly paving the way to revolutionize the treatment of type 1 diabetes. Several categories~     have emerged: dual-hormone (insulin and glucagon) closed-loop systems and closed-loop systems~     with insulin only, one variety of which is the low glucose suspend safety feature now~     available from Medtronic (MiniMed 530G with Enlite). The study described within this protocol~     is designed to test the efficacy of a new closed-loop algorithm for managing blood glucose in~     people with type 1 diabetes before and after exercise. The new algorithm will have 3 modes: a~     single hormone insulin only mode, a dual-hormone insulin and glucagon mode and an insulin~     only mode with predictive low glucose suspend, all with an exercise detection algorithm. The~     purpose of this study is to determine whether a dual hormone AP with an exercise detection~     algorithm outperforms both single hormone AP and a low glucose suspend algorithm and sensor~     augmented pump therapy using the subject's own insulin pump.~   "
53802|NCT02862717|"~     End-stage renal disease represents a major problem for public health, and is a severe disease~     affecting hundreds of millions of people in the world and increasing rapidly. It brings about~     complex implications to social and economic structures of every nation. Providing renal~     replacement therapy including , peritoneal dialysis and renal transplants for ESRD patients~     are resource intensive. Possible options have been proposed to ease the burden include early~     medical intervention to slow the progression of chronic kidney disease in high-risk patients,~     promotion of renal transplantation, and use of the most cost-effective dialysis therapy~     without compromising outcome. In Malaysia, despite growing financial pressure in health care~     system, cost-effectiveness studies of RRT modalities are scarce.The prevalence of ESRD~     patients on dialysis are approximately 34, 767 as of 2014 and expected to rise significantly~     in the foreseeable future. Thus, the sustainability of dialysis therapy is uncertain. This~     study aimed to assess the cost utility of hemodialysis and continuous ambulatory peritoneal~     dialysis treatment from Malaysia Ministry of Health perspective. One hundred and eighty~     patients will be recruited from five state hospitals via National Renal Registry. Patients'~     resource utilization including overhead costs, medications, dialysis consumables and~     hospitalizations will be recorded using specially designed case report form. Patients'~     quality of life will be assessed using validated EQ-5D-3L questionnaire. Survival analysis~     will be conducted based on NRR data. Next, a hypothetical cohort Markov model will be~     constructed to assess the cost utility of HD and CAPD using varying levels of CAPD use versus~     current practice. The data collection period is from 1st October 2016 to 30th September 2017.~     Incremental cost effectiveness ratio is the primary outcome of this study.~   "
53803|NCT02862704|"~     The purpose of this study is to collect the data on the safety and potential effectiveness of~     intra-tumor injection of MG7-CART cells under ultrasound guidance in patients with liver~     metastases expressing MG7 positively.~   "
53804|NCT02862691|"~     The goal of this study is to compare the speed and adequacy of pain relief in Emergency~     Department patients with a toothache after an oral analgesic or a local anesthetic~     administered as a nerve block or by local infiltration.~   "
53805|NCT02862678|"~     Head and neck squamous cell carcinoma are frequent. The chemoradiotherapy protocols are part~     of the reference treatment of locally advanced stage tumors. Diffusion-weighted MRI (DW-MRI)~     is a non radiating imaging, not requiring injection of gadolinium, giving informations on~     tumor activity, based on the brownian motion of water molecules. The differences in motion~     are expressed by the apparent diffusion coefficient (ADC). The ADC variations reflect changes~     in water molecules motion and redistribution between the intra- and extracellular~     compartments. Several studies have shown that malignant lesions have an ADC coefficient~     lowered as compared to benign lesions.~   "
53806|NCT02862665|"~     In complex cardiac surgery with prolonged cardiopulmonary bypass, allogeneic blood products~     transfusions are often necessary to control intraoperative and postoperative bleeding.~     Furthermore, approximately 50% of all patients undergoing cardiac surgery are anemic before~     surgery, and patients with normal hemoglobin level may become anemic during and/or after~     surgery. Perioperative transfusion carries risks far beyond transmission of infection and has~     been demonstrated to be associated with adverse outcomes related to postoperative pulmonary~     complications, decreased renal function and increased mortality. Thus, the important of blood~     conservation stratigies to minimize transfusion is being increasingly emphasized. In recent~     trial by Johansson and colleagues, they concluded that the perioperative administration of~     intravenous iron isomaltoside 1000 increased the hemoglobin level and prevented anemia 4~     weeks after cardiac surgery. Therefore, perioperative iron isomaltoside 1000 administration~     among the patients undergoing complex valvular heart surgery could reduce not only the~     perioperative allogeneic transfusion but also the incidence of postoperative adverse events.~     The aim of this study is to examine the effect of perioperative iron isomaltoside 1000~     administration on transfusion requirements in patients undergoing complex valvular heart~     surgery.~   "
53807|NCT02862652|"~     Acute lymphoblastic leukemia is the most common malignancy of the child. Current therapeutic~     strategies allow healing of over 80% of children. However these treatments are associated~     with toxicity, with a mortality of 1-2%. The most frequent complications, occuring during~     treatment initiation, are the thromboembolic complications.~      The most commonly accepted explanation is that of an anti-thrombin depletion by chemotherapy~     used in the treatment, L-asparaginase. But the anti-thrombin supplementation showed no~     efficacy in the prevention of these thromboembolic complications. Therefore most authors~     consider that a multifactorial mechanism is behind these events, involving both treatment and~     malignant cells. The interaction of these two factors participate in the damage of the~     vascular endothelium.~      The microparticles are membrane fragments derived from budding from the membrane of activated~     cells or apoptosis. Their thrombogenic role is linked to the expression of coagulation~     activators such as tissue factor. It is also associated with their role in the modulation of~     signaling pathways involved in the invasiveness and angiogenesis in endothelial cells.~      In acute lymphoblastic leukemia, the presence and role of microparticles have not been~     studied. Our hypothesis is that of production of microparticles upon lysis of blasts then~     upon activation of endothelial cells induced by the induction therapy, participating in a~     procoagulant phenotype.~   "
53808|NCT02862639|"~     The current management of osteoarthritis is based on non-pharmacological and pharmacological~     means which include intra-articular injections.~      The recommendations on the management of hip osteoarthritis stipulate that intra-articular~     injections of corticosteroid may be considered in patients with an exacerbation not~     responding to oral treatments. Several recent studies show the effectiveness of~     intra-articular corticosteroids compared with anesthetics. The intra-articular injection of~     viscosupplementation alone has never been validated in this indication since controlled~     studies did not show efficacy over placebo. At present, viscosupplementation is considered an~     anti-osteoarthritic symptomatic slow-acting and its interest is not yet established in hip~     osteoarthritis.~   "
53810|NCT02862613|"~     Objectives:~      To evaluate the safety and effectiveness of cell therapy using Precision Cells Combined With~     TACE in Advanced Liver Cancer.~      Eligibility:~      Individuals greater than or equal to 18 years of age and less than or equal to 65 years of~     age who have been diagnosed with Advanced Liver Cancer.~   "
53811|NCT02862600|"~     The purpose of this study is to evaluate the effect of perhexiline on exercise performance~     (efficacy) and safety in patients with hypertrophic cardiomyopathy and moderate-to-severe~     heart failure following dosing for 16 weeks.~   "
53812|NCT02862587|"~     Objectives:~      To evaluate the safety and effectiveness of cell therapy using precision cells to treat~     Advanced Lung Cancer.~      Eligibility:~      Individuals greater than or equal to 18 years of age and less than or equal to 65 years of~     age who have been diagnosed with Advanced Lung Cancer.~   "
53813|NCT02862574|"~     The primary objective of this study is to evaluate the efficacy of andecaliximab (GS-5745)~     versus placebo as an add-on therapy to a tumor necrosis factor (TNF) inhibitor and~     methotrexate in adults with moderate to severe rheumatoid arthritis (RA).~   "
53814|NCT02862561|"~     Objectives:~      To evaluate the safety and effectiveness of cell therapy using Precision Cell Immunotherapy~     to treat Advanced Gastric Cancer.~      Eligibility:~      Individuals greater than or equal to 18 years of age and less than or equal to 65 years of~     age who have been diagnosed with Advanced Gastric Cancer.~   "
53815|NCT02862548|"~     The primary objectives of this study are to evaluate the safety, tolerability, and efficacy~     of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF)-containing regimens~     in participants with chronic hepatitis B virus (HBV) infection and Stage 2 or greater chronic~     kidney disease who have received a liver transplant.~   "
53816|NCT02862535|"~     The primary objective of this study is to characterize the safety and tolerability of~     andecaliximab (GS-5745) as monotherapy and in combination with anti-cancer agents in Japanese~     participants with inoperable advanced or recurrent gastric or recurrent gastroesophageal~     junction (GEJ) adenocarcinoma.~   "
53817|NCT02862522|"~     Uric acid is a risk factor for coronary artery disease (CED) in postmenopausal women but the~     association with inflammation and coronary microvascular endothelial dysfunction is not~     well-defined. The aim of this study was to determine the relationship of serum uric acid,~     inflammatory markers and CED.~   "
53818|NCT02862509|"~     o Chronic rhinosinusitis is one of the most common health issue affected American population.~     Surgery plays an important role in the patients who failed the medical treatment. The most~     difficult location to be operated endoscopically is the frontal sinus. Frontal sinus is also~     found to be one of the most common sinus for residual and recurrence after the operation.~     Intranasal steroid seems to be one of the most beneficent post-sinus surgery cares. The~     topical therapy can be delivered by many approaches. According to the standard clinical~     practice guideline and recommendations, intranasal corticosteroid spray is suggested. The~     technique proved to have greater distribution than standard intranasal spray is instillation~     of steroid nose drops. The head position for instillation of steroid nose drops proven to~     have a greater access to olfactory cleft and frontal area is Vertex-to-floor position.~   "
53819|NCT02862496|"~     The purpose of the study is to determine whether maternal bone resorption would be seen in~     Hyperemesis Gravidarum and could be detected in early period using serum vitamin D levels,~     serum calcium (Ca) levels, serum parathormone (PTH) levels and urine N- telopeptide levels in~     the patients with Hyperemesis Gravidarum.~   "
53820|NCT02862483|"~     The efficacy and safety of the combination of tamsulosin and tadalafil in men with lower~     urinary tract symptoms due to benign prostatic hyperplasia and Erectile Dysfunction: a~     randomized, double blinded, parallel design, active controlled, multi-center, phase 3~     clinical trial~   "
53821|NCT02862470|"~     The investigators expected to enroll 30 patients with papillary, follicular or anaplastic~     thyroid cancer, and collect their urine samples before operation, immediately after~     operation, post-operative 3, 6 12 months. The investigators will analyze the urine exosomal~     proteins and probable biological markers. The investigators hope to find the prognostic~     biological markers via this prospective study. The investigators further hope to find newly~     therapeutic mechanism and medications for such patients with poorly-differentiated or~     anaplastic thyroid cancer.~   "
53822|NCT02862457|"~     This is an open-label, non-randomized, Phase I study of epacadostat (INCB024360) alone and in~     combination with pembrolizumab with chemotherapy and pembrolizumab without chemotherapy in~     participants with advanced solid tumors. The primary objective of the trial is to evaluate~     the safety and tolerability of epacadostat administered alone and in combination with~     pembrolizumab with and without chemotherapy.~   "
53823|NCT02862444|"~     Postpartum depression (PPD) is a highly prevalent and serious mental health problem and is~     defined as the most recent episode of depression occurring between four weeks and twelve~     months after childbirth. PPD has negative effects, which are usually strongest during the~     first six months and may decrease the quality of mother-child interaction, adversely~     affecting the child's behavior and emotional and cognitive development, as well as the spouse~     marital relationship.PPD prevalence is estimated at 10 to 20%. A recent studies among~     Arab-Bedouin women, reported 31% - 43 of PPD.~      Aims: To develop and implement a culturally appropriate intervention program by using focus~     group (FGs) methodology~      Methods and Research program description: The study includes two phases. First, qualitative~     study will be conducted by using focus groups (FGs) method and based on the results of this~     phase we will develop a culturally based program. The second phase will include~     implementation and evaluation of the effectiveness of a culturally appropriate intervention.~   "
53824|NCT02862431|"~     The purpose of this study is to assess the safety and tolerability of JNJ-64565111 in adult~     Men and Women (of non-child bearing potential) with Type 2 Diabetes Mellitus.~   "
53825|NCT02862418|"~     This research study has 2 purposes:~        1. To learn about new ways to use Magnetic Resonance Imaging (MRI) to take clearer pictures~          of the lungs. A type of MRI called Ultra Short Echo Time (UTE) will be used as well as~          traditional MRI.~        2. To collect images and health information about lungs that have different kinds of lung~          diseases to compare to healthy lungs. This collection will help researchers and~          clinicians to better understand lung variations in health and disease.~      This study will involve one MRI session that will take about 10 to 30 minutes and for some~     participants a breathing test that measures how well the lungs are working. This test is~     called spirometry.~   "
53826|NCT02862405|"~     The loss of central vision causes difficulty not only in reading but also in faces~     recognition, and in particular in the identification of facial expression, objects or spaces.~     These visual deficits have been mainly studied in relation with reading, which is the main~     complaint of these kind of patients. However, there are not enough data regarding perception~     of objects and spaces in this population. Then, the objectives are to study the~     visual-spatial abilities in individuals with vision loss, and altered cognitive processes,~     (2) to develop clinics tools for early detection and quantification of visual-spatial~     deficits and (3)to understand the capacities of normal peripheral vision in order to test the~     possibility of potential training for use of peripheral vision when central vision is~     impaired by an ophthalmic pathology.~   "
53827|NCT02862392|"~     The hypothesis of this study is that progressive AIS is characterized by a disorder of~     orthostatic postural control. The analysis and the treatment of posturographic signal on~     computerized integrate force plates, coupled to clinical and radiographic examinations, could~     highlight predictive and reliable factors at the moment of diagnosis. Thus, it could help the~     clinician in his therapeutic approach, based on the postural control improvement~     (individualized prescription in kinesitherapy, better adaptation to orthopedic treatments by~     corset). This method is non-invasive, without side effects, fast and achievable in routine~     care at the moment of the diagnosis of AIS.~   "
53828|NCT02862379|"~     The risk of falling affects more than one third of people over 65 years old and over 50% of~     persons over 80 years. These falls have important consequences for the autonomy of the~     elderly patient and also increase the risk of sequelae and death.~      The goal of this study is to evaluate a personalized rehabilitation program for elderly~     patients that fall for the first time and to measure the impact on the fear of falling of~     these patients. This intervention is a home-based program combining exercises, home~     modifications and education on fall risk factors.~   "
53829|NCT02862366|"~     Patients with myeloproliferative neoplasms Philadelphia chromosome negative (MPNsPh1-) such~     as Essential thrombocytosis (ET), Polycythemia vera (PV) and Primary Myelofibrosis (PMF) have~     a higher risk of arterial or deep-vein thrombosis. This is responsible for a significant~     increase in mortality (up to 31% of increase in thrombosis risk in ET). Cellular inflation~     and blood hyperviscosity, resulting from these diseases, fail to account for these~     thromboses, as more than 50% of thrombotic complications happen under adapted antineoplastic~     drug treatment.~      These last years, cellular microparticles (MPs) have been shown to play a major role in~     thrombogenesis. MPs are generated by apoptosis or the activation of malignant cells,~     platelets, endothelial cells or monocytes. They are fragments of plasma membrane, smaller~     than 1 µm, rich in phosphatidylserine, which can express the tissue factor and serve as~     support for the coagulation factors. Increase in the plasma concentration of procoagulant~     platelet microparticles has been demonstrated in other thrombotic diseases (acute coronary~     syndrome, disseminated intravascular coagulation DIC, etc.). The working hypothesis is that~     platelet microparticles are involved in the hypercoagulability of MPNs patients.~   "
53830|NCT02862353|"~     The drug immune thrombocytopenia (TIM) are the most common drug cytopenias. They result from~     a peripheral destruction of platelets in the presence of the drug only. They usually involve~     immunoglobulin G (IgG) directed against either the drug molecule bound to a carrier protein~     or, by autoimmunity, against a hidden epitope newly exposed as a result of treatment. The~     most common drugs involved are quinine, some antibiotics, nonsteroidal anti-inflammatory~     drugs or anticonvulsants but the list is not exhaustive.~      in the case of new-onset thrombocytopenia and after eliminating other possible causes, a TIM~     is suspected but the offending drug is difficult to identify in generally poly-medicated~     patients.~      Several drugs may be suspected and the clinician uses biology for rapid assistance to the~     de-prescription and reduces unnecessary therapeutic substitutions in an always difficult~     clinical situation.~      The Immunology Laboratory of the University Hospital of Saint-Etienne has developed a~     biological test of thrombocytopenia induction in the presence of the drug and the patient's~     serum that is to say its antibodies and complement fractions with cytometry reading flow.~     This Induction Test in vitro TIM (TITIM) is simple, fast, inexpensive, easy to transfer in~     hospital laboratories. But this test must be validated on well-documented clinical cases.~      The purpose of this pilot project is to validate the technical and assess the clinical~     specificity of the test TITIM for hard imputability drugs validated by a committee of experts~     combining a posteriori of clinical and biological criteria of routine.~   "
53831|NCT02862340|"~     Autism, ranked among the '' pervasive developmental disorders' (ASD), is characterized by~     disturbances in the areas of reciprocal social interaction, communication and behavior,~     interests and activities restricted, repetitive. Various studies indicate that autistic~     disorder is subjected to a genetic predisposition, most likely polygenic and heterogeneous.~     However, no major gene responsible for this disorder has yet been identified. Given the link~     between the Fragile X syndrome (the most common form of mental retardation (MR) hereditary)~     and autistic behavior, it seems interesting to look, also, a possible link to the molecular~     level. Among the proteins interacting with FMRP (absent protein in fragile X patients), the~     investigators were interested to CYFIP1, protein encoded by the gene CYFIP1 appears to be a~     good candidate gene involved in the RM and autism by its chromosomal position and function.~     As FMR1, CYFIP1 is expressed in the brain cortex, hippocampus and Purkinje cells of the~     cerebellum. This protein co-localizes and interacts with Rac and FMRP, which are both~     involved in neurogenesis and cognitive development. In humans, the gene encoding CYFIP1 is~     located in the 15q11-q13. Now, the only autosomal abnormalities most frequently observed in~     autism are those involving the proximal 15q region, including duplications or 15q11-q13~     triplications interstitial, of maternal origin.~      These data suggest that an / or more autism genes responsible are probably present in the~     15q11-q13 chromosomal region, although no gene has yet been identified. Thus, the study of~     the role of CYFIP1 gene in patients with autism spectrum disorders would most likely~     contributory.~      The investigators wish to study the involvement of the 15q11-q13 chromosomal region and~     CYFIP1 gene in autistic disorder in a hundred patients from the Autism Resource Centre (ARC)~     Nice PACA antenna, over a two year period.~      The diagnosis and assessment report of children likely to be included in this study will be~     conducted at ARC Nice. Balance sheets are made according to the recommendations of the High~     Authority of Health for diagnosis of infantile autism and PDD. These children are then sent~     to the Genetic Consultation Nice Hospital where an analysis of the background and a specific~     morphological examination will be realized..~   "
53832|NCT02862327|"~     Prospective monocentric double-blind controlled randomised trial Aim is to assess prolonged~     postsurgical analgesia by intravenous dexamethasone versus intravenous placebo, after~     ultrasound guided axillary brachial plexus block~   "
53844|NCT02862171|"~     A follow-on, open label trial to assess continued safety of and adherence to the~     Dapivirine(25mg) vaginal ring-004 in healthy, HIV-negative women~   "
54151|NCT02858167|"~     The purpose of this study is to define a reference population for FDG-PET neurological~     examinations starting from patients having FDG-PET to supervise a non-complicated lymphoma~     (tumor in remission, low disabling chronic tumor).~   "
53833|NCT02862314|"~     There is actually no consensus in place defining for which patients with suspected inhalation~     pneumonia antibiotic treatment should be initiated and what the duration of this antibiotic~     treatment should be.~      This absence of recommendations results in excessive use of antibiotics, in emergence of~     multi-resistant strains and increase of costs. Several studies have been performed~     investigating antibiotic treatment based on procalcitonin values and have demonstrated a~     decreased use of antibiotics without change in mortality rates, in duration of~     hospitalization, in occurrence of super-infections or in infection relapse rate. Of the~     studies performed in an intensive care setting, none has specifically studied inhalation~     pneumonia.~      The objective of this study is to determine whether use of a decisional algorithm based on~     procalcitonin values allows reducing antibiotics exposure in patients who are intubated~     because of coma in comparison with standard care according to actual guidelines and clinical~     experience with respect to ventilator-acquired pneumonia.~      The study has a prospective, multi-centre, comparative, randomized, open design. It is a~     superiority study, with as primary parameter the duration of antibiotic therapy during the~     first 15 days after admission in the intensive care unit (ICU).~      Patients can be included in this study if they are intubated for coma (Glasgow Coma Scale~     (GCS) ≤ 8) within 48 hours following admission to the hospital and with a foreseen duration~     of ventilation exceeding 48 hours.~      There will be two treatment groups, stratified by centre and randomised in blocs of 4: one~     group for which treatment initiation and discontinuation will be guided by a~     procalcitonin-based decisional algorithm and a control group to whom antibiotics will be~     administered according to the standard protocols of each participating centre.~      Based on an estimated duration of antibiotic treatment of 6.2 days, a risk -significance α~     level- of 5%, a power of 90% and a reduction of antibiotic treatment duration of 25% in the~     treatment arm guided by procalcitonin values, the number of patients to be included is 83 per~     treatment arm. Taking into account a loss of 10% for patients lost to follow-up, 166 patients~     should be included.~   "
53834|NCT02862301|"~     The aim of the study is to compare the enzymatic activity of HATs and HDACs in peripheral~     blood mononuclear cell (PBMC) of patients with a clinically isolated syndrome (CIS group) and~     healthy controls (control group).~   "
53835|NCT02862288|"~     The aims of this work were to assess the feasibility, efficacy, short-term outcome and safety~     of microwave ablation in the treatment of malignant bone, lung and renal tumors.~   "
53836|NCT02862275|"~     This pilot phase I trial studies the side effects of atezolizumab in treating patients with~     cancer following adoptive cell transfer. Monoclonal antibodies, such as atezolizumab, may~     interfere with the ability of tumor cells to grow and spread.~   "
53837|NCT02862262|"~     A three-arm, multi-site clinical evaluation of the ARIES Bordetella Assay for the detection~     and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B.~     parapertussis) nucleic acids in prospectively collected, de-identified, left-over clinical~     specimens; banked, pre-selected clinical specimens; and contrived specimens.~   "
53838|NCT02862249|"~     Patients with advanced cirrhosis have enteric dysbiosis with small bowel bacterial overgrowth~     and translocation of bacteria and their products across the gut epithelial barrier. This~     culminates in systemic inflammation and endotoxemia which induces innate immune dysfunction~     predisposing to infection and development of complications such as bleeding, sepsis and~     hepatic encephalopathy. It also plays a key role in the natural history of cirrhosis by~     influencing the rate of progression to advanced liver disease and terminal liver failure.~      The investigators propose an intervention utilising Faecal Microbiota Transplantation (FMT)~     from a healthy donor to modify the gut microbiome alleviating gut dysbiosis and immune~     dysfunction. This may ultimately reduce the progression to chronic liver failure and the~     development of infection and organ dysfunction.~      The primary objective of this study will be to assess whether stabilising gut dysbiosis with~     FMT in patients with advanced cirrhosis is both feasible and safe.~   "
53839|NCT02862236|"~     The experiment is aimed to examine the effect of common psychiatric drugs on several~     cognitive functions, in a healthy and subclinical adult population. The investigators~     hypothesize that baseline stress level regulates drugs effects on cognitive performance.~     Additionally, different levels of stress may moderate the drugs-cognition relations. In order~     to examine our hypotheses, the investigators focus on two anxiolytic drugs: herbal based~     (Hypericum) and benzodiazepine (Alprazolam). about 160 healthy (and/or subclinically anxious)~     subjects (aged 18-40) will be administered with single dose of the drugs (between subjects)~     on two different experiment dates - so subject that will be administered with a drug will~     receive placebo on the second date, or vice versa. The design will be double blind and second~     experiment day will occur at least 14 days after the first. Prior to administration, the~     investigators will measure depression and trait anxiety and state stress and anxiety, using~     inventories and cortisol in saliva test. Subjects will undergo a battery of computerized~     cognitive tests measuring working memory, attention, executive control, and visual~     perception. State anxiety and stress will be also measured before and after the battery. A~     gentle stress manipulation will be conducted during some of the tests.~      currently, the research is focusing on a Hypericum and placebo only, regarding 60~     participants.~   "
53840|NCT02862223|"~     This open-label study investigated the effectiveness of Neprinol on maintaining healthy~     cardiovascular health in overweight and obese adults. Subjects took 3 capsules, 3 times per~     day over a period of 12 weeks.~   "
53841|NCT02862210|"~     Frontotemporal dementia (FTD) is a progressive neurodegenerative illness that affects the~     frontal and anterior temporal lobes of the brain. Changes in behavior, including agitation,~     aggression, and repetitive behaviors, are common symptoms in FTD. The investigators currently~     do not have good medications to treat these symptoms in FTD, and the medications the~     investigators use often have side effects. In this project, the investigators will test the~     use of low-dose lithium, compared to a placebo pill, for the treatment of behavioral symptoms~     in FTD. Lithium greatly reduces the behavioral symptoms of bipolar disorder, and many have~     found low-dose lithium to be well-tolerated in patients with dementia. Lithium appears to~     inhibit the creation of a protein involved in many cases of FTD called tau.~   "
53842|NCT02862197|"~     The purpose of this study is examine whether invasive pulmonary artery pressure (PAP)~     monitoring could be beneficial for the patients in dialysis treatment. Ten implantable~     pressure sensors (CardioMEMS ®) will be implanted and the PAPs of the individual participants~     are recorded during and in between the routine dialysis treatment sessions. This is an~     exploratory pilot study, where major interest lies in the values and changes in PAP in~     relation to other hemodynamic parameters among patients in dialysis treatment. Implanted~     device is only monitoring the patient without any effect on the actual treatment.~   "
53843|NCT02862184|"~     Many women will likely experience a sexual problem in their lifetimes. The Prevalence of~     Female Sexual Problems Associated with Distress and Determinants of Treatment Seeking~     (PRESIDE) study surveyed more than 30,000 U.S. women aged >18 years regarding sexual~     function. Results from this study estimated that 12% of women experience a diagnosable sexual~     disorder that causes personal distress, with lack of sexual desire being the most prevalent.~     - See more at:~     http://www.uspharmacist.com/content/d/featured_articles/c/56908/#sthash.LTDkyRlR.dpuf~   "
53846|NCT02862145|"~     This study is designed to investigate the biomarkers, pharmacodynamics and pharmacokinetics~     of the liposomal micro-ribonucleic acid-34 (microRNA-34, miR-34). Melanoma patients with~     easily accessible lesions will undergo serial biopsies and serial blood samples will be~     collected.~   "
53847|NCT02862132|"~     Vedolizumab (VDZ) is a humanized immunoglobulin G1 monoclonal antibody acting against α4β7~     integrin which modulates lymphocyte trafficking in the gut.~      Results from the adult GEMINI-1 and GEMINI-2 trials demonstrated clinical efficacy in~     induction and maintenance of remission in both ulcerative colitis (UC) and Crohn's disease~     (CD), respectively.~      Recent real life cohorts in adults support the effectiveness of VDZ in inducing and~     maintaining remission, both in CD and UC. In pediatrics, there are very limited data on the~     use of VDZ besides two retrospective case series.~      Data on immunogenicity and therapeutic drug monitoring (TDM) of VDZ is conflicting in adults~     and practically non-existent in children.~      The investigators aim to prospectively explore the real life short and longer term outcomes~     of VDZ in pediatric IBD (including growth) and to develop a prediction model for treatment~     success based on VDZ trough levels and other clinical and laboratory variables.~   "
53848|NCT02862119|"~     Background: The best strategy for ST-elevation myocardial infarction (STEMI) patients with~     multi-vessel disease, who undergo primary percutaneous coronary intervention (PCI) of the~     infarct-related artery (IRA) in the acute phase with remaining multivessel disease, is still~     not well established. Current guidelines recommend PCI of only the infarct related artery~     (IRA). However, recent small scale randomised controlled trials indicate that full~     revascularization of these non-infarct related arteries during the index procedure is~     superior to initial conservative treatment. Fractional flow reserve (FFR), a method used to~     determine ischemia-inducing lesions, has been shown to be superior to angiography-guided PCI~     in stable angina.~      Objective and methods: To test the hypothesis that a strategy of systematic complete~     revascularization with FFR-guided PCI following STEMI/very high risk NSTEMI leads to improved~     clinical outcomes at one year compared to initial conservative management of non-culprit~     lesions. The trial is a prospective international multicentre registry-based randomized~     controlled trial with combined primary endpoint of all-cause mortality and non-fatal MI at~     one year. Key secondary endpoint is unplanned revascularization. 4052 patients with acute~     STEMI/very high risk NSTEMI with multi-vessel disease in Sweden, Denmark, Norway, Finland,~     Iceland, Latvia and Poland will be randomized into 2 arms:~        1. FFR-guided PCI of non-culprit lesions during index hospital admission or~        2. Initial conservative management following acute PCI of the culprit lesion(s) or~      Randomization and data collection in the registries - the Swedish Coronary Angiography and~     Angioplasty Registry (SCAAR) and corresponding registries in other countries (or electronic~     data capture) - will ensure low bias, high inclusion rate and excellent follow-up of events~     at a low cost. Adjudication of clinical events and collection of data from other registries~     including death cause registries is also planned.~      Significance: If this study shows that FFR-guided PCI of non-culprit lesions in STEMI/very~     high risk NSTEMI improves clinical outcome compared to conventional management this will~     change practise in how we should best manage these patients. Therefore a study of this size~     will definitely be of great importance in determining future guidelines for this large~     patient group to reduce both morbidity and mortality.~   "
53849|NCT02862106|"~     The purpose is to evaluate efficacy and safety of therapeutic HBV vaccine (mimogen-based)~     treatment in chronic hepatitis B patients and to explore the most effective dosage and~     provide the rational for optimal dosing schedule.~   "
53850|NCT02862093|"~     Repetitive Transcranial Magnetic Stimulation (rTMS) of the dorsolateral prefrontal cortex may~     affect neuro-adaptations associated with alcohol use disorder (AUD), potentially influencing~     craving and alcohol intake.~      Investigators investigated alcohol intake and dopamine transporter (DAT) availability by~     Single Photon Emission Computed Tomography (SPECT) in the striatum of AUD patients before and~     after deep rTMS.~   "
53851|NCT02862067|"~     To determine the effects of SGLT2 inhibition with empagliflozin on cardio-respiratory fitness~     in patients with systolic heart failure.~   "
53852|NCT02862054|"~     To evaluate the clinical value of splenectomy as a treatment for relapsed haemophagocytic~     lymphohistiocytosis (HLH) in patient with unknown etiology.~   "
53853|NCT02862041|"~     In this prospective, randomized, double blinded study, the needle tip and needle shaft~     visibility of echogenic and nonechogenic needle were compared in ultrasound guided~     infraclavicular brachial plexus block. Sixty patients scheduled for upper extremity surgery~     were included in the study. Patients were randomised into two groups, group E (Echogenic) and~     group NE (Nonechogenic) with 30 subjects in each group. Under ultrasound guidance~     infraclavicular brachial plexus block was performed. In Group E, Pajunk Sonoplex echogenic~     needle was used and in Group NE, Stimuplex Braun nonechogenic needle was used. The subjective~     assessment for needle tip/shaft visibility as scored by the performer and the objective~     assessment from the recorded block procedure video were noted.~   "
53854|NCT02862028|"~     Objectives:~      To evaluate the safety and effectiveness of cell therapy using herinCAR-PD1 cells to treat~     relapsed or refractory cancer.~      Eligibility:~      Individuals greater than or equal to 18 years of age and less than or equal to 70 years of~     age who have been diagnosed with relapsed or refractory cancer that has not responded to or~     has relapsed after standard treatment.~   "
53855|NCT02862015|"~     Patients with pancreatic cancer often suffer from pain. Because of such a pain, their quality~     of life have seriously deteriorated. There have been a few studies that showed an effect for~     pain control by hyperthermia (heating the patient's body). However, there are several~     limitations in conventional hyperthermia.~      In a previous pilot study (NCT02150135), we found the improvement of quality of life,~     function, and symptom.~      From this background, the investigators tried to show the effect of Oncothermia with~     conventional chemotherapy for pain control, increasing quality of life, and anti-tumor~     treatment.~   "
53856|NCT02862002|"~     A first empirical evidence on the difficulties of observance of morphine in cancer patients~     invited a multidisciplinary team to initiate an innovative quality approach. It shows the~     lack of transcript of a comprehensive care causing a problem for monitoring actions~     undertaken for the relief of pain. In addition, two exploratory studies targeting the~     expectations and needs of the Patient Therapeutic Education (E.T.P) receiving strong opioids.~      The E.T.P, public health priority, provides a framework for action and improving care. In~     oncology, the involvement of the patient in pain relief and management of opioids represents~     an axis of intervention more appropriate. Yet, it is not found in literature. In our~     department, we conduct an experimental therapeutic education program type caratif and a~     nurse consultation FTE receiving opioids on the model of nursing care of J. Watson~     (humanist emphasis promoting interpersonal teaching-learning mobilizing the patient~     experience). The ETP folder and its tools have been continuously validated with patients. The~     heart of the educational process is in the patient's complex path neat oncology and relies on~     interaction and creativity between patient and caregivers.~   "
54860|NCT02848898|"~     This trial consists of application of little devices (named Equistasi®) generating focal~     vibrations to treat spasticity in neurological patients, affected by multiple sclerosis. The~     expected effects are on gait and postural instability.~   "
53857|NCT02861989|"~     Osteoporosis (OP) and subsequent fractures (OP fractures) are a source of morbidity and high~     mortality in the elderly. Despite numerous programs aiming at improving OP care, the~     prevention, diagnostic and treatment remain suboptimal. Barriers to a better care are~     multiple, both in the general and at-risk population, and in medical practitioners. Since~     they do not perceive their susceptibility to OP, people do not see the benefit of prevention.~     In addition, physicians do not give sufficient importance to OP prevention and care, despite~     the existence of guidelines.~      The investigators implemented a qualitative study to explore the knowledge and~     representations regarding osteoporosis in the general and at-risk population and in doctors~     in Rhône-Alpes Region, France, using focus groups with women and men and semi-structured~     face-to-face interviews with general practitioners. Understanding barriers to osteoporosis~     care in patients and general practitioners will help to set up effective strategies to~     improve prevention and treatment.~   "
53858|NCT02861976|"~     The current study seeks to begin the crucial work of creating effective protocols to prevent~     opioid misuse, addiction, and related complications by developing and pilot testing an opioid~     risk screening protocol at Wisconsin trauma centers.~   "
53859|NCT02861963|"~     The aim is to compare effective growth true hypoplastic pulmonary arteries using Right~     Ventricle Outflow Tract Reconstruction by femoral allogenic vein valve conduit and~     systemic-to-pulmonary artery shunts (modified Blalock-Taussig shunt or central shunts)~   "
53860|NCT02861950|"~     This is a prospective randomized multi-center non-inferiority trial conducted through the~     Pediatric Regional Anesthesia Network study sites to determine if caudal block increases the~     incidence of urethrocutaneous fistula following distal or mid shaft hypospadias repair~     compared with penile nerve block.~   "
53861|NCT02861937|"~     Human IL-21 is present in gingival crevicular fluid in periodontal health, gingivitis and~     chronic periodontitis. A significant increase in the concentration of IL-21 in gingival~     crevicular fluid is observed with an increase in the amount of periodontal destruction. Non-~     surgical periodontal therapy aided in decrease of GCF IL-21 levels in clinical gingivitis and~     chronic periodontitis~   "
53862|NCT02861924|"~     Measure microcirculatory responses after localized ischemia obtained by local application of~     pressure (laser speckle).~   "
53863|NCT02861911|"~     Facioscapulohumeral muscular dystrophy (FSHD) is an autosomal dominant disease characterized~     by progressive weakness and atrophy of specific skeletal muscles. One of the major problems~     of patients affected by FSHD is the limitation in performing daily activities induced by the~     progressive muscle weakness. This sedentary lifestyle can cause a debilitative cycle, and~     neuromuscular deconditioning can even aggravate the muscular deficiencies. Recent studies~     have indicated the safety and the effectiveness of moderate aerobic training programs in~     patients with FSHD. However, these training programs have limited applicability in patients~     with more severe muscular weakness. Artificial strength training by means of neuromuscular~     electrical stimulation (NMES) appears to be a promising rehabilitation strategy for FSHD~     patients suffering from neuromuscular disorders. Therefore we propose to investigate the~     feasibility, safety, and effectiveness of NMES strength training to counteract quadriceps~     muscle weakness in patients affected by FSHD.~   "
53864|NCT02861898|"~     Primary brain cancer kills up to 10,000 Americans a year. These brain tumors are typically~     treated by surgery, radiation therapy and chemotherapy, either individually or in~     combination. Present therapies are inadequate, as evidenced by the low 5-year survival rate~     for brain cancer patients, with median survival at approximately 12 months. Glioma is the~     most common form of primary brain cancer, afflicting approximately 7,000 patients in the~     United States each year. These highly malignant cancers remain a significant unmet clinical~     need in oncology. GBM often has a high expression EFGR (Epidermal Growth Factor Receptor)~     which is blocked by Cetuximab (CTX). The investigators have recently completed a separate~     Phase I clinical trial using superselective intra-arterial cerebral infusion (SIACI) of CTX~     after blood brain barrier disruption (BBBD) for recurrent GBM (Chakraborty et al, in~     revision, Journal of Neurooncology). The investigators found that intra-arterial infusion of~     CTX is well tolerated with few adverse effects. The investigators hypothesize that in~     patients with newly diagnosed GBM, repeated SIACI of this drug after BBBD will be safe and~     efficacious for our patients when combined with standard chemoradiation (STUPP protocol).~      This trial will be a non-randomized open label Phase I/II clinical trial. In addition to~     standard chemotherapy and radiation therapy (STUPP protocol) the patient will be given CTX~     intra-arterially after BBBD for a total of three doses at approximately post surgery days 30,~     120 and 210.~   "
53865|NCT02861885|"~     There are a few studies regarding Sessile Serrated Lesions (SSL). They are recently~     identified as precancerous lesions. Yet, digestive tract serrated lesions would be part of a~     new colic carcinogenesis way : the serrated tumor way. Evolution from polyp to cancer would~     be faster than through the usual adenoma to cancer way. It would be then responsible of a lot~     of missed lesions or interval cancer. The missed SSL rate is estimated at between 27% and~     59%.~      Current diagnosis methods show weakness to identify those SSL. In order to improve their~     detection, the investigators dispose of several coloration techniques. Indigo carmine~     chromoendoscopy enhance neoplastic lesion detection as part of the hereditary rectal~     carcinoma screening. NBI electronic coloration, which is faster and easier has not shown any~     efficacy on the adenoma detection rate, except for patients with Lynch syndrome.~      The objective is to better describe the SSL endoscopic semiology (detection and~     characterization) and to establish standards for the endoscopic techniques in order to~     improve the colonoscopy diagnosis quality. The investigators propose to evaluate 2~     fundamental endoscopic techniques (Narrow Band Imaging (NBI) and indigo carmine), widely used~     for other indications, in comparison with the White Light technique (WLI).~      Therefore, the investigators propose a prospective, observational, multicentric cohort study~     in order to 1) define SSL endoscopic various aspects 2) establish which technique (white~     light, Narrow Band Imaging, indigo carmine chromoendoscopy) is the best to diagnose SSL,~     namely detection and characterization 3) evaluate the multifocal dimension rate for those~     lesions at ascending colon level.~      The diagnosis impact is immediate, and could allow to consider an update for boh endoscopic~     NICE and Kudo Pit Pattern classification, and good practice guidances for colonoscopic~     diagnosis. Better SSL detectability thus their systematic resection could have a long term~     effect in reducing both colon cancer rate and interval cancer~   "
53891|NCT02861547|"~     Traumatic brain injury (TBI) is a serious condition with high morbidity and mortality. The~     Glasgow score alone, assessed at the initial phase, is not enough to determine the prognosis.~      The aim of this study is to define and to evaluate a prognostic score for early death based~     on clinical and CT-scan findings in an observational retrospective derivation cohort of~     patients hospitalized for traumatic brain injury.~      This cohort will allow us to carry out a uni- and then multi-variate analysis so as to create~     a prognostic score for early death.~      We will subsequently test this score in a prospective validation cohort.~   "
53866|NCT02861872|"~     Ovarian cancer is the third most common gynecological malignancy worldwide. Because of late,~     aspecific symptoms, the disease is usually diagnosed at an advanced stage. Most patients~     experience recurrence and die as a result of the disease within 5 years. Treatment is a~     combination of surgical debulking and systemic administered chemotherapy. Intra-peritoneal~     (IP) chemotherapy with is currently considered the most effective treatment. In patients with~     at least an optimal surgical debulking, this leads to an improvement in life expectancy from~     50 to 66 months. IP administration of chemotherapeutic agents is still not common practice.~     Furthermore recent studies revealed that cancer cells express a variety of tumor antigens,~     which can be targeted by the immune system. Also ovarian cancer shows evidence of a role for~     the immune system in clinical outcome. Novel insights into the mechanism of action of~     chemotherapy indicate that the efficacy of chemotherapeutic interventions are dependent on~     the modulation of the immune system. The impression exists that since IP chemotherapy is~     used, relatively more recurrences outside the abdominal cavity are observed. As of yet, no~     studies have described pharmacokinetics and pharmacodynamics of IP administered cisplatin and~     paclitaxel in the blood circulation. The investigators propose to study the use of this~     aspiration fluid from the IP cavity as a biomarker for the efficacy of chemotherapy~     intervention, monitor the effect of chemotherapy on IP tumor cells in the peritoneal cavity~     and monitor the effect of chemotherapy on immune cells present in the IP cavity. As well the~     investigators propose to correlate the presence and amount of tumor cells in peritoneal fluid~     with the debulking efficacy and CA 125 levels. Secondary to this the investigators intend to~     determine the pharmacokinetics of cisplatin and paclitaxel when administered in the IP cavity~     in the central circulation (plasma) as well as in the peritoneal fluid. In this observational~     explorative study women, aged younger than 70 years, who will receive standard IP~     chemotherapy for advanced epithelial ovarian cancer, who are in an adequate physical and~     biochemical state to receive chemotherapy are included. Immunological cell counts, tumor~     marker, immunological cell pathway activation and plasma concentrations of cisplatinum and~     paclitaxel in venous blood and in fluid aspirated from the abdominal cavity will be measured.~   "
53867|NCT02861859|"~     The purpose of this study is to evaluate whether adding olanzapine 5mg to standard antiemetic~     medication can significantly reduce chemotherapy-induced nausea and vomiting in breast cancer~     patients receiving emetogenic chemotherapy regimens such as anthracycline with~     cyclophosphamide-based chemotherapy and platinum-based chemotherapy.~      To help clinicians prescribe antiemetic medications in a more patient-centered,~     evidence-based and cost-effective manner, we've developed the world's first validated~     risk-stratification tool for chemotherapy-induced nausea and vomiting (CINV) and because of~     this, it is now possible to perform a trial of personalized precision antiemetic therapy for~     breast cancer patients.~      Despite widespread antiemetic use, chemotherapy-induced nausea and vomiting (CINV) remains~     among the most feared and expected side effects of chemotherapy for breast cancer.~     Inadequately controlled CINV can significantly reduce a patient's quality of life, impair~     functional activity, lead to chemotherapy dose delays and reductions, and even~     discontinuation of treatment. The merit of current antiemetic medications is based on their~     ability to control chemotherapy-induced vomiting, but not necessarily nausea, and nausea is~     the major issue for breast cancer patients.~      With olanzapine demonstrating significant promise in preventing acute and delayed nausea, the~     investigators are proposing to evaluate guideline-recommended aprepitant-based triple regimen~     compared to the same regimen plus olanzapine (5 mg) for patients at high personal risk for~     CINV. For patients at low personal risk for CINV the investigators will also evaluate~     guideline-recommended double antiemetic regimen compared to the same regimen plus olanzapine~     (5 mg).~   "
53868|NCT02861846|"~     Beyond 60 years, the prevalence of epilepsy is estimated at approximately 1% and increases~     with age. In these patients, the etiology of epilepsy is unknown in 25% of cases, even up to~     55% after 65 years. Although new-onset epilepsy in the elderly is associated with a vascular~     disease in 50% of cases, the hypothesis of an ongoing neurodegenerative process, including an~     Alzheimer's disease (AD), is also common. However, investigators do not have any marker that~     might help to identify the patients who develop epilepsy after 60 years and who might be,~     despite a normal cognitive functioning, already engaged in the pathophysiological process of~     AD.~      A number of data suggest a link between the pathophysiological process of AD and~     epileptogenesis:~      (i) a third of patients with epilepsy develops MA, (ii) the occurrence of epilepsy in AD is~     an aggravating factor for cognition, (iii) in animal models of AD, the relationship between~     neuronal hyperexcitability and amyloid deposits is bidirectional, the amyloid protein has a~     pro-seizure effect and the presence of epilepsy increases the amyloid deposits, (iv) in these~     models, the administration of an antiepileptic drug protects from deterioration of cognition,~     (v) the close relationship between amyloid and neuronal hyperexcitability might be mediated~     by the inflammatory processes associated with AD, and particularly the microglial activation~     which role in epileptogenesis has been shown elsewhere.~      Investigators hypothesize that in a subgroup of patients who develop epilepsy after 60 years,~     the occurrence of epilepsy might reflect the presence of an ongoing amyloid pathology. Our~     goal is to identify through biomarkers of AD in the cerebrospinal fluid of patients who~     develop an epilepsy after 60 years with normal MRI and normal cognition those at high risk of~     later developing clinically defined AD.~      Identifying patients with amyloid pathology which would be expressed through epilepsy before~     the onset of cognitive dysfunction might help to adapt both the management of seizures and of~     the cognitive dysfunction.~   "
53869|NCT02861833|"~     This is a first care research focuses on the study of adaptation strategies implemented by~     cancerous wound patients. Today, advances in treatment generally increases the life~     expectancy of a patient with cancer. the patients thus live longer with their wound. How to~     live then? The literature review shows that there is research on adaptation strategies in~     cancer pathology and that different factors seem to interact with these strategies. However~     the investigators have not found written on the theme cancerous wound and adaptation~     strategies.~      the investigators conducted a pilot study of this research in medical oncology, Prof. service~     Duffaud CHU Timone, which allowed us to highlight patient adherence and motivation centers~     contacted but also areas for improvement. Indeed, the investigators now were doing a study of~     adaptation strategies implemented by the patient time T of his life. However, adaptation is a~     process in constant motion, the investigators want to identify two different time patients~     coping strategies following a specific charge nurse taking.~   "
53870|NCT02861820|"~     The study purpose is to examine whether there are structural or functional differences in the~     brains of individuals who use cocaine or amphetamines as opposed to control participants who~     have never used cocaine or amphetamines. More specifically, it will allow the investigator to~     see how the brain changes once people get sober and how those changes relate to successful~     recovery. This study will allow the investigator to examine the interaction between~     cocaine/amphetamines and impulsivity (meaning to act on impulse rather than thought). Results~     from this study will inform new biologically-based interventions to compliment existing~     treatment programs, in the hope of leading the field in a new direction.~   "
53871|NCT02861807|"~     Alcohol use disorder (AUD) impacts millions of Americans and is associated with significant~     behavioral, social, economic, medical, and neurobiological dysfunction, yet current~     behavioral treatments for AUD are only modestly effective. The proposed research will test~     the efficacy of a novel behavioral intervention, which combines brain stimulation with~     mindfulness-based relapse prevention, and is hypothesized to improve neural dysfunction and~     ultimately lead to large effect size reductions in heavy drinking among individuals with AUD.~     Given that mindfulness and brain stimulation are already available for home use there is~     great potential for the ultimate dissemination of the intervention on a large scale, which~     could have a significant impact on public health.~   "
56591|NCT02826252|"~     The aim of this study is to examine inhalation behavior in patients enrolled in the German~     Ventavis patient support program Ventaplus when these patients are switched from Ventavis~     (Iloprost) 10 μg/mL to Ventavis (Iloprost) 20 μg/mL formulation.~   "
53872|NCT02861794|"~     Total joint replacement is an efficacious treatment for osteoarthritis of hips and knees.~     Both total knee replacement (TKR) and total hip replacements (THR) have excellent implant~     survivorship. However, patients' satisfaction is lower in TKR than THR. A possible cause of~     the discrepancy is the unnatural knee kinematics after TKR. Various implants designs have~     been developed to solve the problem. However, most of their designs are based on experimental~     data and little has been studied about their actual performance in vivo. In this study, the~     investigators will analyze the in vivo stability of the Global Medacta Knee Sphere (GMK~     Sphere) implant. Migration of the implants will be monitored with a high precision measuring~     method called Radiostereometric Analysis (RSA). The investigators assume the investigators~     study will contribute the development of more satisfying knee implants.~   "
53873|NCT02861781|"~     This project aims at identifying new determinants of type 2 diabetes in severe obesity. To do~     so, a biological collection, including tissues of interest in the field of metabolism, will~     be collected during bariatric surgery in obese patients. Three different groups of metabolic~     status of patients, corresponding to different stages of evolution of the disease, will be~     constituted: type 2 diabetes, insulin resistance, insulin sensitivity.~      The main objective is to compare, between these 3 groups of patients, several biological~     processes that may be involved in the pathophysiology of type 2 diabetes and disorders~     associated with obesity, including:~        -  Abnormalities of the transcriptome, proteome, metabolome in all target tissues (plasma,~          serum, muscle, subcutaneous and visceral adipose tissue, omental artery, liver)~        -  Identification of metabolic signatures, protein and miRNA in plasma~        -  Immunoinflammatory response in adipose tissue~        -  Polymorphisms SNP from whole blood~        -  Histological analysis of tissue sections This main objective will be studied on samples~          taken at the time of surgery Secondary objectives will be to study the changes in~          metabolites, proteins and miRNA in plasma level 3 and 12 months after the completion of~          surgery, according to the initial metabolic state.~   "
53874|NCT02861768|"~     The presence of M. tuberculosis in non-invasive throat swabs of patients withdrawn for~     suspected tuberculosis.~      Hypothesis 10% of patients infected by M. tuberculosis are carrier of M. tuberculosis~     pharyngeal.~      Secondary~        1. Measure the time to diagnosis of pulmonary TB by comparing the sample versus noninvasive~          pharyngeal samples taken routinely.~        2. Evaluation of the direct cost of the diagnosis of M. tuberculosis by comparing the~          sample versus noninvasive pharyngeal samples taken routinely.~        3. Beijing genotype prevalence among patients with pulmonary tuberculosis.~   "
53875|NCT02861755|"~     Major depressive disorder affects over 120 million people worldwide. Only 50% of Americans~     with depression receive adequate treatment, and one-third of those receiving treatment do not~     benefit. In this pilot project investigators will bring together two approaches that have the~     promise to reach large numbers of depression sufferers: a skills-based intervention for~     increasing positive affect and experiences in depressed individuals, delivered in an~     inexpensive self-paced mobile format. The study will make use of smartphone technology to~     improve conventional outcome measurement via in-the-moment emotion sampling and mobile~     assessment of heart rate variability, a predictor of cardiac health that may mediate some of~     the health effects of depression. The aims are: 1) Retool the existing web-based positive~     emotion intervention for use on smartphones, with innovative exercises that help participants~     bring the skills they are learning into real-life situations; 2) Perform a small feasibility~     trial of the mobile intervention on individuals with clinical depression recruited online 3)~     Eventually incorporate feedback from the small feasibility trial to improve the online~     intervention and conduct a full randomized trial on a larger scale~   "
53876|NCT02861742|"~     The KALICOU 3 study will evaluate the effect of emotional skills of patients and their~     partners on their individual disease subjective experience during care pathways, from~     chemotherapy to surveillance.~   "
53877|NCT02861729|"~     The purpose of this randomized controlled clinical trial is to evaluate the clinical outcomes~     of Partial Coverage Restorations fabricated with zirconia-reinforced lithium silicate ceramic~     system compared to partial coverage restorations fabricated with lithium disilicate ceramic~     system.~   "
53878|NCT02861716|"~     In this study the investigators aim to determine the analgesic effect and side effects of~     intrathecal fentanyl and dexmedetomidine as adjuvant to local anesthetics in pediatric~     patients undergoing major abdominal cancer surgeries.~   "
53879|NCT02861703|"~     Obesity presents serious psychological and physical consequences for breast cancer survivors,~     including diminished quality of life, poorer prognosis and increased mortality. As such,~     there is a great need to develop strategies for these women to maintain optimal body weight.~     Diet and exercise have been shown to lead to successful weight loss among this population but~     these effects are seldom sustained, plausibly because these efforts alone overlook less~     obvious, but equally important, psychosocial factors that can interfere with prolonged~     progress. This study will implement a group-based intervention addressing diet and exercise~     along with other psychosocial issues related to survivorship such as depression, fatigue,~     body image and social support. Based on the growing popularity and benefits of computer-based~     health care, including convenience and anonymity, this intervention will also be offered~     online, representing the first of its kind. It is hypothesized that 1) women in both~     intervention groups will achieve significantly greater loss in weight and improvement in~     psychosocial well-being than those in a control group and 2) women in the online group will~     achieve outcomes comparable to those in the face-to-face group. This research has the ability~     to improve the long-term health of breast cancer survivors by incorporating psychosocial~     interventions into standard medical care practices and has the potential to increase~     accessibility of these services using online technology.~   "
53880|NCT02861690|"~     The purpose of this study is to evaluate the safety, tolerance and efficacy of Liposomal~     Paclitaxel With Nedaplatin as First-line in patients with Advanced or Recurrent Esophageal~     Carcinoma~   "
53892|NCT02861534|"~     This is a randomized, placebo-controlled, parallel-group, multi-center, double-blind, event~     driven study of vericiguat (MK-1242) in participants with HFrEF. The primary hypothesis is~     vericiguat (MK-1242) is superior to placebo in increasing the time to first occurrence of the~     composite of cardiovascular (CV) death or heart failure (HF) hospitalization in participants~     with HFrEF.~   "
98844|NCT02273453|"~     Study to determine the presence of a hang-over effect in healthy volunteers the day after the~     administration of Songha® Night~   "
53881|NCT02861677|"~     Background: Pharmacists have been proven to improve patient outcomes, medication adherence,~     glycemic control, reduce blood pressure, low-density lipoprotein, health care costs and~     length of hospital stay, and enhance quality of life.~      Objective: to measure the impact of clinical pharmacy service on patient care and cost saving~     of patients at inpatient wards and ambulatory care clinics of Jimma University Specialized~     Hospital.~      Methods: single center Randomized Controlled Trial will be conducted. Participants will be~     assigned to either pharmacy professionals' intervention group or non-intervention (control)~     group based on computer generated random number. The study will be done from July 26 to~     September 15, 2016. The total sample size is calculated with Open Epi online sample size~     calculator with 95% CI and 80% power. The total sample size is found to be 146 for inpatients~     and 473 for outpatients. Linear regression, student's t-test, logistic regression and~     chi-square test will be used for statistical analysis. Variables with p<0.05 will be~     considered statistically significant.~   "
53882|NCT02861664|"~     This study will evaluate the effectiveness of an experimental dentifrice containing stannous~     fluoride, an established dentine tubule occlusion technology, at reducing dentine~     hypersensitivity (DH) compared to a negative control dentifrice. The test and control~     dentifrices will be administered for a total of 8 weeks, with assessments (via evaporative~     air and tactile stimuli) at baseline, and after 4 and 8 weeks twice-daily use.~   "
53883|NCT02861651|"~     Acute erythroid leukemia (AEL) is a morphologically distinct, infrequent (o5%) acute myeloid~     leukemia (AML) designed as M6 in the French- American-British (FAB) classification. The World~     Health Organization classification recognizes two subclasses, M6a, a leukemia with myeloid~     blast cells, and M6b, a very rare, purely erythroid AML. It may be difficult to distinguish~     between a myelodysplastic syndrome and AEL because of the erythroblastic proliferation, which~     is increased when dysplasia is present. No recurrent cytogenetic abnormality is specific of~     AEL and the prognosis is poor with a median survival of 17 months. A study of 14 genes in a~     series of 92 cases has shown that mutations are frequent in AEL and somewhat differ from the~     other AMLs by the lower and higher proportion of FLT3-ITD and TP53 mutations, respectively.~     Only three cases of AEL are reported in the TCGA database. To further characterize AEL,~     determine whether it constitutes a distinct class of AML and document the reasons for its~     poor prognosis, the investigators will search for molecular alterations in 40 M6a-AMLs using~     array comparative genomic hybridization (aCGH) and next-generation sequencing (NGS) of 106~     genes known or suspected to have a role in myeloid malignancies or in erythrocyte~     differentiation.~   "
53884|NCT02861638|"~     Postoperative rehabilitation is required for a successful outcome following total hip~     arthroplasty. Traditionally rehabilitative programs aim to increase range of motion, to~     strengthen quadriceps, to restore normal gait, and to recover independence in activities of~     daily living. In the last decade action observation treatment, in addition to conventional~     physiotherapy has been proposed as a treatment method in rehabilitative medicine. There is~     growing evidence of the applicability of action observation training in rehabilitative~     medicine, indeed it has been applied in the rehabilitation of stroke of Parkinson disease of~     cerebral palsy and of aphasia.~      Nevertheless those are small studies and one of them included a mixed population of hip and~     knee arthroplasty.~   "
53885|NCT02861625|"~     The aim of this randomized multicenter study is to evaluate the impact in offering the~     condolence letter to the family caregivers (indicated as the reliable person by the patient~     himself at each hospitalization) and a bereavement consultation with the reference physician.~   "
53886|NCT02861612|"~     This study seeks to evaluate the efficacy of nerve transfers in restoring hand function in~     patients with cervical spinal injuries.~   "
53887|NCT02861599|"~     Before proposing this observational study protocol, a randomized study was attempted. This~     consisted in proposing to families of children with difficulties in learning to read, via the~     speech therapists who were treating them, to take part in a randomized trial that compared~     speech therapy alone with a combination of speech therapy and proprioceptive therapy. If~     parents agreed in principle with the study, the child underwent a complementary speech~     therapy examination and was referred to the nearest investigating doctor for inclusion.~     However, this study had to be abandoned because of insufficient recruitment (2 patients~     included in 1 year). Despite the motivation and training of participating speech therapists,~     proposing a study based on randomization to families often in distress proved to be extremely~     difficult, as their conviction of the interest of proprioceptive therapy was greater than the~     available scientific evidence suggested. Direct recruitment by investigating ophthalmologists~     was not possible because they were consulted directly by the families so as to obtain~     proprioceptive therapy. The principle of randomization would thus not have been accepted.~      In light of the above, we decided to turn towards a non-randomized study comparing outcomes~     in two groups of children:~        -  children who consulted an ophthalmologist who proposed proprioceptive therapy in Côte~          d'Or~        -  children managed by one of the four speech therapists who do not propose proprioceptive~          therapy and who accepted the principle of the study.~   "
53888|NCT02861586|"~     The purpose of this study is to evaluate the immunogenicity and safety of a novel vaccine~     against Chikungunya virus after one or two vaccinations by comparison of two different dose~     levels.~   "
53889|NCT02861573|"~     The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475)~     combination therapy in patients with metastatic castrate resistant prostate cancer (mCRPC).~     There will be three cohorts in this study with 70 participants enrolled in each cohort:~     Cohort A will receive pembrolizumab + olaparib, Cohort B will receive pembrolizumab +~     docetaxel + prednisone, and Cohort C will receive pembrolizumab + enzalutamide. Outcome~     measures will be assessed individually for each cohort.~   "
53890|NCT02861560|"~     A prospective case series investigating the efficacy and safety of dehydrated human~     amnion/chorion membrane (dHACM) in the treatment of patients with Stage II or III pressure~     ulcers~   "
53902|NCT02861404|"~     The principal objective of the study is the evaluation of the role of Human Papilloma Virus~     (HPV) in plantar warts (prevalence, genotype), resistant or not, treated or not, cured or~     not. This epidemiological study is an ancillary study of the prospective, randomized~     controlled, clinical study VRAIE (sponsor: APHP) comparing 5 usual strategies in the~     management of plantar warts.~   "
56592|NCT02826239|"~     The investigators aim to evaluated the effect of postural changes on novel lung function~     parameters derived from multiple-breath-washout.~   "
53893|NCT02861521|"~     Moving one's joints through their full range of motion (ROM) is crucial for health and~     wellbeing. Those who are unable to do so have difficulty carrying out simple activities like~     walking or feeding themselves. Lost joint ROM is called a contracture. Osteoarthritis (OA) is~     the most common form of arthritis. About a third of people with knee OA develop knee flexion~     contractures (KFlCs), the inability to fully straighten the knee. Having a KFlC before a knee~     replacement is a big risk factor for redeveloping one after the operation. Many people with a~     KFlC in the knee for surgery also have a KFlC in the other knee. The investigators believe~     that this non-surgical KFlC increases the risk of re-developing a KFlC in the surgical knee~     after surgery by encouraging bending of the surgical knee to avoid one leg being shorter than~     the other. No one has ever looked at whether fixing this leg length difference using a shoe~     lift would prevent this problem and there is little information to help design such a study.~     Here the investigators will see if testing shoe lift use for preventing KFlC is feasible. The~     investigators hypothesis is that a study evaluating the benefit of using a shoe lift to~     correct leg length difference in the non-surgical knee is feasible.~   "
53894|NCT02861508|"~     The purpose of the proposed research is to examine whether incorporating point-of-care~     ultrasound (POCUS) early in diagnostic work-up of cardiopulmonary complaints will affect~     diagnosis, time to condition-specific intervention, and ultimately patient outcomes compared~     to usual care.~   "
53895|NCT02861495|"~     The proposed study of humeral shaft fractures in adults will examine outcomes in patients~     treated with the Humeral Trauma Nail System to treat displaced humeral shaft fractures~     (displaced OTA code 12A, B, or C), nonunions, or malunions. The device to be studied uses an~     internal gear system controlled wirelessly by rare earth magnets, which typically offers~     distraction for lengthening. In the humerus however, during the treatment of acute fractures,~     this percutaneously inserted nail can also offer compression during the healing process,~     thereby negating the effect of gravity, which may in turn lead to a faster and more~     consistent rate of union. Furthermore, in cases of slower healing the dynamic properties of~     the nail may employ an accordion technique (alternating compression-distraction, a feature~     unique to this implant.~   "
53896|NCT02861482|"~     Postpartum hemorrhage (PPH) is the top reason for maternal deaths in China. The four major~     causes of PPH include uterine atony, genital tract laceration, placenta factors and systemic~     medical disorders (including inherited and acquired coagulopathy). Management of PPH contains~     the application of uterotonic agents, using hemostasis agents, transfusion of blood component~     products, conservative procedures (intrauterine packing or balloon tamponade, compression~     sutures, vascular ligation and uterine artery embolization using sponges), and even~     hysterectomy.~      The Bakri Balloon has attained its efficacy and popularity ever since it was invented by~     Doctor YN. Bakri. Although it is recommended by many countries as a routine procedure for PPH~     management, the Bakri Balloon is not yet a first choice in China due to lack in clinical data~     of preventive usage.~      The aim of this study is to prove the efficacy and safety of the Bakri Balloon in early~     management of PPH.~   "
53897|NCT02861469|"~     This qualitative study aimed to describe and understand the factors leading to the admission~     in emergency unit of patients coming from their home, in an end of life situation.~      This study was conducted in the university hospital of Besançon, France. Semi-structured~     interviews were conducted with general practitioners and family members in order to~     understand the factors leading, from their points of view, to the admission in emergency unit~     whereas this hospitalization wasn't necessary.~   "
53898|NCT02861456|"~     The goal of the proposed research is to test the feasibility of a functional progression~     program to reduce cost and possible radiation exposure for adolescent athletes with low back~     pain. Specifically the investigators plan to test the feasibility of using progression in~     rehabilitation to pragmatically differentially diagnose and treat adolescent athletes with~     low back pain, instead of using advanced imaging which is the current practice. The~     investigators propose to recruit 20 participants, with 10 of usual care (advanced imaging)~     and 10 of proposed intervention (functional progression) to assess the feasibility of using~     functional progress to guide treatment. The outcomes measured will be number of days for~     rest, time to start regular rehabilitation, pain experienced, functional outcomes, ability to~     return to sport, time needed to return to sport. If this pilot demonstrates the feasibility~     and a decreased rate of advanced imaging and similar clinical outcomes the investigators plan~     to progress this work into larger trials.~   "
53899|NCT02861443|"~     The main objective of this study was to determine the frequency of the practice of colonic~     irrigation (CI) among patients with a colostomy,.~      Other objectives are:~        -  To compare the quality of life between a group of patients with a colostomy and~          practicing CI versus a group of patients with a colostomy without CI.~        -  To determine the causes of non-realization of the CI or failure.~        -  To determine the conditions of realization of colonic irrigation by the return of user~          experience (time of day when the CI is practiced, amount and type of fluid used, time~          spent in the bathroom, time to recurrence of stool, media used between two irrigations).~   "
53900|NCT02861430|"~     Unmask Trial aims to evaluate the Kappa concordance between immunochemistry and molecular~     biology to detecting cancer cells in sentinel lymph node in patients undergoing colectomy for~     non metastatic colon cancer.~   "
53901|NCT02861417|"~     Any time the words you, your, I, or me appear, it is meant to apply to the potential~     participant.~      The goal of this clinical research study is to learn if busulfan with cyclophosphamide (when~     given with other helper drugs listed below) can help control acute myeloid leukemia (AML),~     acute lymphocytic leukemia (ALL), chronic myeloid leukemia (CML), chronic lymphoproliferative~     disorder, myelodysplastic syndrome (MDS), myeloproliferative syndrome, Non-Hodgkins lymphoma~     (NHL), Hodgkins lymphoma (HL), or multiple myeloma (MM) when given before a stem cell~     transplant. The safety of these study drug combinations will also be studied.~      This is an investigational study. Busulfan, fludarabine, cyclophosphamide, filgrastim, MMF,~     tacrolimus, and thiotepa are FDA approved and commercially available. It is investigational~     to give cyclophosphamide in combination with busulfan and fludarabine with a stem cell~     transplant.~      You and/or your insurance provider will be responsible for the costs of all drugs and the~     infusion of stem cells.~      Up to 200 participants will take part in this study. All will be enrolled at MD Anderson.~   "
56593|NCT02826226|"~     The investigators aim to evaluate the effect of bronchodilatator testing on~     multiple-breath-washout derived lung function parameters.~   "
53903|NCT02861391|"~     The study is intended to assess the safety and efficacy of CO2 AcuPulse laser treatment in~     patients with urinary stress incontinence (USI). Eligible subjects will receive 3 treatment~     sessions, 4 weeks apart and 3 Follow Up visits, at 1, 3, and 6 months following the last~     treatment.~   "
53904|NCT02861378|"~     Dental procedures often require the use of local anesthesia. The effects of the anesthesia~     usually linger for some time after the dental procedure is completed which can lead to~     discomfort and occasionally injury from lip/tongue biting. Clinical trials have shown~     phentolamine mesylate (OraVerse) to be effective at reducing the amount of time to reversal~     of local anesthesia compared to sham injections. However, no trials have been conducted~     comparing phentolamine mesylate to a true control injection. Such trials are needed in order~     to definitively show that it is the phentolamine mesylate itself that is causing the~     reduction in anesthesia rather than a dilution effect.~      The objective of the proposed research is to conduct a pilot-scale randomized clinical trial~     evaluating the difference in time required to the return of normal soft-tissue sensation and~     function in participants who had received an inferior alveolar nerve block (using 2%~     Lidocaine 1:100,000 epinephrine), followed by an injection with either 1) OraVerse~     (phentolamine mesylate) or 2) sterile physiological water (control).~      The study population will comprise dentistry and dental hygiene students of the second year~     classes at Dalhousie University, Halifax, NS, Canada. This study population has been chosen~     because these students usually practice dental anesthesia on each other as a part of a course~     on local anesthesia.~      This proposed pilot scale study will be a double-blind controlled trial using parallel~     groups. As part of their usual anaesthesia course, the dental and dental hygiene students~     will be practicing their inferior alveolar nerve injections on one another using 2% Lidocaine~     1:100,000 epinephrine. Students who decide to participate in the study will be randomly~     assigned to one of two groups: Group 1 will receive an injection of OraVerse (treatment~     group), while Group 2 will receive an injection of sterile physiological water (control~     group). The time required to the return of soft-tissue sensation and function will be~     assessed using a questionnaire.~   "
53905|NCT02861365|"~     This is a study of the perfusion of the myocardium in adults with specific forms of repaired~     congenital heart disease using established cardiac MRI techniques and correlating perfusion~     with clinical outcomes.~   "
53906|NCT02861352|"~     The purpose of this study is to determine the effect of a moderate decrease in dietary zinc~     on DNA strand breaks and other cellular zinc biomarkers.~   "
53907|NCT02861339|"~     A retrospective study has shown the association between the inflammatory bowel diseases (IBD)~     and the presence of a keratoconus. This new study will measure the prevalence of keratoconus~     and follow its activity in patients affected by IBD and followed up in~     hepatology-gastroenterology department at Nancy Hospital. The prevalence of keratoconus will~     be compared to known data of literature about general population.~      The secondary purpose is to search for a relationship between the presence of a keratoconus~     and activity criteria of IBD.~      Perspectives are a systematic screening for keratoconus in patients affected by IBD with the~     amelioration of the ophthalmologic care of IBD patients and confirmation of the recent~     hypothesis of inflammatory origin of keratoconus.~   "
53908|NCT02861326|"~     Aim: The aim of this study was to evaluate the relationship between initial probing depth~     (IPD) and changes in clinical parameters following non-surgical periodontal treatment (NPT)~     in chronic periodontitis patients.~      Material and Methods: A total of 1672 periodontal pockets having 3 mm≤IPD≤9 mm in 15 chronic~     periodontitis patients were included. NPT consisting of oral hygiene instructions, scaling~     and root planing was applied in two sessions. Probing depth (PD), clinical attachment level,~     gingival recession (GR) were measured before and eight weeks after treatment. Pocket sites~     were grouped according to their IPD and root number of teeth as single- or multi-rooted.~   "
53909|NCT02861313|"~     Comparing the quality of life and periimplant condition around a single implant retained~     mandibular overdenture in two groups one will have a ball attachment and the other is having~     a (CM-LOC) one.~   "
53910|NCT02861300|"~     This study has two portions. The main goal of the Phase I portion of this research study is~     to see what doses of CB-839 and capecitabine can safely be given to patients without having~     too many side effects. Other purposes of this research study will be to determine what side~     effects are seen with this combination of medicines. The Phase II portion of the study will~     test how many patients show shrinkage in their tumor with this combination of medicines and~     what changes occur inside the cancer cells and blood cells after treatment.~   "
53911|NCT02861287|"~     This study aims to realize an economic evaluation of the introduction of Plerixafor in~     addition to G-CSF and alternative options, in patients with multiple myeloma (MM) who failed~     or insufficiently mobilize peripheral blood stem and progenitor cells in response to G-CSF~     alone.~   "
53912|NCT02861274|"~     OBJECTIVES: To evaluate syncope recurrence at follow up in patients with a positive cardio~     inhibitory response to the head up tilt testing (HUT) evaluation.~      METHODS: 36 consecutive patients affected by cardio inhibitory syncope to HUT without~     asystolia (2A type) have been enrolled in this study. These patients have been studied by~     electrophysiological study (ES). After ES patients have been differently treated~     (interventional treatment group A, v/s drug therapy group), and followed up during 360 days,~     to evaluate syncope recurrences.~   "
53913|NCT02861261|"~     The purpose of this study is to conduct a multicenter randomized, double-blind,~     placebo-controlled clinical trial, evaluating the effects and change of gut microbiota after~     berberine and/or probiotics administration in patients with newly diagnosed type 2 diabetes~   "
53914|NCT02861248|"~     A prospective study to evaluate the efficacy and safety of FMRT for treating non-hypertrophic~     post-burn scars in an Asian population.~   "
53915|NCT02861235|"~     Myocardial perfusion tomoscintigraphy is a routine medicine procedure to check for the~     presence and severity of abnormalities of myocardial perfusion, as well as the extension of~     infarction residua. However, actual imagery devices (gamma cameras) have low resolution and~     detection sensitivity. A new semiconductor camera has 8 to 10 time higher detection~     sensitivity and could allow proportionally diminishing injected activities or recording~     times. Only one pilot study has been recently published on this type of camera, the D.SPECT~     camera.~      This study will compare images recorded during 15 to 20 minutes by conventional cameras and 2~     to 4 minutes by D.SPECT camera in patients doing tomoscintigraphy under usual conditions. The~     purpose is to demonstrate the equivalence of images recorded by two camera types for~     diagnostic information and the secondary purpose is to demonstrate the superiority of the~     D.SPECT camera in terms of image quality.~   "
53916|NCT02861222|"~     The purpose of this study is to determine the toxicity and tolerance of Myocet® in children~     and adolescents with refractory or relapsed malignant glioma, with a dose diminished of 20%~     of the dose recommended for adults and a dose recommended for adults, administered in single~     dose in 1-hour perfusion each 21 days.~      Other purposes are to determine the recommended dose of Myocet and to assess the response to~     drug. Pharmacokinetics of doxorubicin (free and encapsulated forms) and its metabolite~     doxorubicinol during 72 hours after Myocet administration will also be studied.~   "
53917|NCT02861209|"~     This study aims to develop, implement and evaluate a care pathway for patients with cancer~     who are treated with oral anticancer drugs (OACD).~      The care pathway will be developed in six hospitals in Flanders, and will be adapted to the~     local setting and situation.~      The investigators hypothesize that the implementation of a care pathway will increase the~     quality of the drug therapy, the communication between health care professionals (HCPs) and~     patients, and will lead to an improved level of self-management and adherence. Moreover, the~     invesitgators hypothesize that the care pathway will facilitate the communication between~     HCPs in the hospital setting and in ambulatory care, and will improve counseling skills,~     self-efficacy and self-confidence of HCPs.~      At the end of the study, a roadmap for the nation-wide implementation of a similar care~     pathway will be constructed based on the experiences of the participating hospitals. This~     roadmap will certainly include an e-learning platform for healthcare professionals.~   "
53918|NCT02861196|"~     This research aims to explore the therapeutic effect of neoadjuvant chemotherapy in muscular~     invasive bladder cancer of T2-4aN0M0, and the survival effect of combined-modality treatment~     model，then to clarify the probability of bladder preservation, corresponding cancer specific~     survival, and the quality of life.~   "
53919|NCT02861183|"~     A Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of Sodium Hyaluronate to~     provide Symptomatic Relief of Lateral Epicondylosis (Tennis Elbow).~   "
53920|NCT02861170|"~     This study evaluates the effectiveness of a brief mindfulness-based intervention on~     post-operative pain and disability among anxious patients with chronic pain undergoing total~     hip arthroplasty.~      All participants will receive an educational brochure and links to videos containing~     strategies for coping with pain and anxiety. The half of the participants who are allocated~     to the treatment arm will also receive a 10 minute mindfulness intervention called a body~     scan.~   "
53921|NCT02861157|"~     The purpose of this project is to test the efficacy of Planet T1D, a mobile and web-based~     technology infrastructure specifically designed to (a) enhance youths' type 1 diabetes~     disease- and treatment-related knowledge through interactive and game-based educational~     materials; (b) support adherence to the treatment regimen through customized task prompts via~     mobile and web-based delivery; and (c) promote patient-provider communication through~     real-world data collection and feedback loops. Investigators will examine the effectiveness~     of the Planet T1D mobile app and website in improving treatment adherence, disease-related~     knowledge, transition readiness, condition management, and the psychological correlates of~     these variables in youth with type 1 diabetes.~   "
53922|NCT02861144|"~     The Hanapū Study: Incentivized Partnerships to Reduce Diabetes Disparities is a randomized~     control trial that will test the effectiveness of partnership incentives plus evidence-based~     education to optimize glycemic outcomes among diabetic patients compared with usual care.~   "
53923|NCT02861131|"~     Substantial respiratory morbidity has been associated with postoperative residual paralysis,~     which is fairly common after general anesthesia involving a neuromuscular blocking agent.~     Common practice in United States is to reverse neuromuscular blockade with neostigmine at the~     end of surgery. A new drug with evidence of more complete neuromuscular reversal has been~     developed, sugammadex. The objective of this study is to determine if a strategy of~     rocuronium neuromuscular reversal with sugammadex will reduce the proportion of subjects with~     any postoperative pulmonary complication, compared to neostigmine.~   "
53924|NCT02861118|"~     The purpose of this study is to evaluate the impact of the co-morbidities profile on~     treatment response in inflammatory bowel disease (IBD) patients.~   "
53925|NCT02861105|"~     The purpose of this study is to assess the efficacy of LMWH treatment in women with~     unexplained infertility and negative immunological markers undergoing ICSI.~   "
53926|NCT02861092|"~     It exists recommendations to get an optimal antibiotic treatment for bone and joint infection~     and prescription of antibiotics in the bone and joint infections on material meets certain~     obligations: the micro-organism must be known, the antibiotic therapy must be started in~     association, obtaining high plasma levels, use of molecules having good bone circulation. It~     is recommended to initially administer treatment with intravenous route and to propose an~     oral relay, under conditions. It is recommended to administer the antibiotic treatment for at~     least 6 weeks.~      The dosages of antibiotics are adapted to the weight of patients in order to respond to those~     recommendations. But little is known about the optimal dose of treatment to give to obese~     patients (BMI>=30) and the frequency of serious adverse events in these patients in which the~     dosage is then higher can be more important compared to non-obese patients. The aim of the~     study is then to evaluate the risk of occurrence of serious adverse events in obese patients~     and to identify risks factors.~      This study consists in a retrospective cohort of obese patients treated for a bone or joint~     infection and having had a serious adverse event. Several data are collected concerning:~     demographics data, treatment responsible of the serious adverse event (molecules, dosage,~     route), description of the serious adverse event, residual rate for vancomycin.~   "
53927|NCT02861079|"~     This study evaluates the addition of transcervical Foley catheter balloon and vaginal~     prostaglandin E2 in induction of labor at term. Half of participants will be used combine~     transcervical Foley catheter balloon and vaginal prostaglandin E2, while the other half will~     be used alone vaginal prostaglandin E2.~   "
53928|NCT02861066|"~     Symptoms of depression and anxiety are extremely prevalent in the population. Unfortunately,~     patients often face barriers to accessing mental health care, particularly psychotherapeutic~     interventions, including long wait-times and demanding therapeutic protocols. For instance,~     Mindfulness-Based Therapy (MBT) has demonstrated effectiveness at decreasing symptoms of~     depression and anxiety, and improving wellbeing; however, 'traditional' MBT can demand over~     30 hours of clinical time, and 50-60 hours of homework, all of which can be barriers to care.~     The goal of this project is to test the effectiveness of an Abbreviated MBT (<10 hours of~     clinical time and <10 hours of homework) in reducing symptoms of depression/anxiety and~     improving wellbeing. If effective, this Abbreviated MBT could reduce barriers to accessing~     mental health care.~   "
54047|NCT02859519|"~     The primary objective of this study is to evaluate the efficacy of topical MOB015B in~     patients with mild to moderate distal subungual onychomycosis (DSO).~      The secondary objective is to evaluate the safety of topical MOB015B in patients with mild to~     moderate DSO.~   "
53929|NCT02861053|"~     The chronic fatigue is observed in approximately 40 % of the patients with a chronic quiet~     inflammatory bowel disease (IBD) and impacts the quality of life of the patients. The~     beneficial role of a regular physical activity on the quality of life of patients having an~     IBD was demonstrated in 5 studies including only 1 controlled one [Bilski, on 2013]. The~     mechanism by which the physical activity could improve the quality of life of the patients~     remains unknown (stress decreased, reduction of the inflammatory process) [Bilski, on 2014].~     Several studies concerning other chronic pathologies such as fibromyalgia, have demonstrated~     the beneficial effect of a regular physical exercise to reduce the fatigue of patients. It~     was recently demonstrated that the chronic fatigue observed in patients with IBD came along~     with a physical reduction in the performances during the exercise test and a reduction in the~     physical activity of the patients [Vogelaar, 2015].~      Our hypothesis is that a regular moderate physical activity could improve physical~     performance during an effort et could reduce the chronic fatigue and improve their quality of~     life.~   "
53930|NCT02861040|"~     The main purpose of this investigational research study is to determine how safe and~     tolerable the study drug volasertib is in combination with liposomal vincristine (Marqibo; an~     FDA-approved drug) in patients with relapsed/refractory acute lymphoblastic leukemia. While~     VSLI demonstrated an overall response rate of 35% in Acute Lymphoblastic Leukemia (ALL)~     patients that had failed to respond to or relapsed after chemotherapy, combining it with~     other agents may increase clinical benefit.~      Volasertib inhibits proteins involved in the cell cycle that are increased in ALL. When~     volasertib inhibits these proteins ALL cells die. In the laboratory, volasertib has been~     shown to increase activity of vincristine against ALL cells. Therefore, we think the~     combination of volasertib and VSLI will be more effective against your leukemia than either~     drug used alone. This study will try to find out what effects, good and/or bad, this drug~     combination has on the patient and their cancer, and to find a dose that may be used in~     future studies.~   "
53931|NCT02861027|"~     Due to the importance of the functions of the gluteus medium, mainly during gait, it becomes~     essential to strengthening early in the musculature. The association of muscle strengthening~     with the Functional Electric Stimulation (FES) comes to accelerate stabilization of hip,~     leading to functional rehabilitation early and improves the quality of life through~     rehabilitation in social life and activities of daily life. Thus, it becomes a relevant study~     to assess objectively the implications of FES in muscle strengthening of gluteus medium~     associated with the Physiotherapy Protocol Total Hip Arthroplasty (PPTHA), through the~     assessment of motor performance in patients undergoing surgery for Total Hip Arthroplasty~     (THA), aiming to better rehabilitation strategies for this population.~      The objective of the research is to assess the effects of functional rehabilitation through~     PPTHA associated with FES in the gluteus medium compared only with the PPTHA, in patients~     undergoing surgery for THA.~      The principal hypothesis is that there is difference between the functional rehabilitation of~     the patients undergoing PPTHA associated with the FES of gluteus medium, after THA and the~     patients submitted only to PPTHA.~   "
53932|NCT02861014|"~     The purpose of this prospective, multicenter, open-label, efficacy, and safety study is to~     assess the efficacy and safety of ocrelizumab in participants with Relapsing Remitting~     Multiple Sclerosis (RRMS) who have had a suboptimal response to an adequate course of a~     Disease-Modifying Treatment (DMT). The study will consist of a Screening period (up to 4~     weeks), an Open-label treatment period (96 weeks; with last dose administered at Week 72),~     and a Follow-up period of at least 2 years.~   "
53933|NCT02861001|"~     Optical guidance for percutaneous tracheotomy in intensive care is usually performed by~     bronchoscopy. Recently, an endotracheal tube with a camera mounted at its tip (VivaSight-SL)~     has been introduced that allows for endotracheal visualization.~      For feasibility evaluation, ten patients in intensive care receive percutaneous tracheotomy~     with optical guidance by the VivaSight-SL tube. If this part is completed with satisfactory~     results, patients are randomized to receive optical guidance by bronchoscopy or by~     VivaSight-SL tube. The primary end point is the visualization through the tube camera of~     endotracheal landmark structures for tracheotomy and visualization of the needle insertion~     (according to score, see detailed description).~   "
53934|NCT02860988|"~     The purpose of this study is to determine differences among incarcerated or recently~     incarcerated fathers who receive targeted services and those who do not.~   "
53935|NCT02860975|"~     The purpose of this study is to define the safety and the biochemical-physiological response~     of prolonged exposure to a normobaric low-oxygen environment in healthy volunteers.~   "
53936|NCT02860962|"~     A proof-of-concept study to determine the antidepressant potential of Dextromethorphan for~     treating depression associated with Major Depressive Disorder in inpatients.~   "
53937|NCT02860949|"~     Multimodal local anesthetic infiltration (LAI) provides effective pain control in patients~     undergoing total knee arthroplasty (TKA). Some surgeons avoid posterior capsular infiltration~     (PCI) for fear of damaging posterior neurovascular structures. Data are limited on the added~     benefits of PCI using different combinations of local anesthetic agents. Therefore, the~     investigator wanted to know the effectiveness of pain control in LAI with and without PCI.~      Half of participants received LAI with PCI, while the other half received LAI without PCI~     during total knee arthroplasty.~   "
53949|NCT02860793|"~     The pseudo tyrosine kinase receptor 7 (PTK7) is an orphan tyrosine kinase receptor assigned~     to the planar cell polarity pathway. PTK7 is expressed in normal myeloid progenitors and~     CD34(+) CD38(-) bone marrow cells in humans. It is also expressed in acute myeloid leukemia~     (AML) and is mostly assigned to granulocytic lineage differentiation. In AML, PTK7 seems to~     convey promigratory and antiapoptotic signals into the cell and represents an independent~     prognosis factor of survival in patients treated with induction chemotherapy. This study aims~     at:~        -  evaluating the impact of PTK7 expression on primary AML cells ex vivo~        -  evaluating the diagnostic and prognostic value of a soluble form of PTK7~   "
53950|NCT02860780|"~     The main purpose of this study is to evaluate the safety of the study drug prexasertib in~     combination with ralimetinib in participants with advanced or metastatic cancer.~   "
53951|NCT02860767|"~     The purpose of the study is to evaluate the concentrations of antibiotics used as empirical~     treatment in serum and periprosthetic tissues during reimplantation of infected hip and knee~     prostheses~   "
98845|NCT02273440|"~     To evaluate the effect of multiple doses of BIIL 284 BS on the pharmacokinetics of a single~     dose of theophylline.~   "
53938|NCT02860936|"~     ACC is rare and represent approximately 25% of salivary gland carcinomas. The standard~     treatment is surgical excision followed by radiotherapy in selected cases. The disease is~     characterized by a progressive course with local and distant recurrences. First-line~     treatment is palliative chemotherapy that had modest results. Expression of the epidermal~     growth factor receptor in ACC of salivary origin has been reported. Several papers report~     that a high percentage of ACCs carries a chromosome translocation that results in the~     overexpression of the oncogene MYB, which is involved in cell proliferation, apoptosis,~     differentiation and in upregulation of several growth and angiogenetic factors contributing~     to the autocrine activation of the FGFR and VEGFR-mediated angiogenesis. Recently two whole~     genome sequencing of several ACC tumor/normal pairs have found mutations in genes involved in~     the FGF/IGF/PI3K pathway corroborating the hypothesis that this subset might benefit from~     inhibitors of this pathway. Based on these premises several antiangiogenic drugs and FGFR~     inhibitors are currently under investigation and a response rate of 11% was observed in ACC.~     Lenvatinib is an oral multiple RTK inhibitor targeting VEGFR-1-3, FGFR-1-4, RET, c-KIT, and~     PDGFR. On February 13, 2015 the drug has been approved by FDA for the treatment of patients~     with locally recurrent or metastatic, radioactive iodine-refractory differentiated thyroid~     cancer. Based on preclinical and clinical data, the investigators believe that targeting~     angiogenesis, FGFR pathway and tumor microenvironment might represent a rational basis to~     test Lenvatinib in patients with relapsed and/or metastatic ACC.~   "
53939|NCT02860923|"~     This hypothalamic obesity is associated with serious metabolic and psychosocial consequences.~      The purpose of the study is to compare the change of body weight after 6 months treatment~     with a lifestyle intervention + exenatide compare to the one after the same lifestyle~     intervention+ placebo in adults patients suffering from a hypothalamic obesity due to~     treatment of craniopharyngioma.~   "
53940|NCT02860910|"~     The general objective of this study is to advance insight into non-pharmacological treatments~     for maturing women that impact psychological health and wellbeing of women adapting to~     menopause, a natural but often challenging developmental milestone.~   "
53941|NCT02860897|"~     PURPOSE: To evaluate patient adherence to cream versus tablet based local estrogen therapy by~     randomizing treatment modalities to determine differences in adherence to either form.~      HYPOTHESIS: There is no difference in adherence to cream versus tablet based local estrogen~     therapy when prescribed as a 6 week course of postoperative therapy after female pelvic~     reconstructive surgery.~   "
53942|NCT02860884|"~     The main objective of this study is to evaluate the ability of infrared spectroscopy to~     discriminate simple hepatic steatosis from NASH~   "
53943|NCT02860871|"~     The main objective of this study is to assess the ability of Fiber-optic Evanescent Wave~     Spectroscopy (FEWS) to discriminate synovial fluids samples of septic arthritis patients from~     other causes of joint effusion by analyzing ex vivo joint fluid samples collected during~     routine clinical care.~   "
53944|NCT02860858|"~     Objective: To evaluate the efficacy of intravitreal aflibercept injection on visual acuity in~     patients with symptomatic macular PCV.~   "
53945|NCT02860845|"~     The purpose of this study is to determine whether a formula of boric acid and probiotics for~     vaginal application is effective in the treatment of symptomatic episodes of vulvovaginitis~     in comparison to pharmacological reference controls (depending on the suspected diagnosis).~   "
53946|NCT02860832|"~     Background and significance: Though the problem of bullying among adolescents is evidently~     increasing and of a serious social concern, it is often undetected until serious outcomes~     have surfaced. In recent years, along with the rapid expansion of the Internet, social~     network services (SNS) and smart phones, cyber-bullying has been growing. Compared to the~     traditional bullying, cyberbullying is unique in nature and potentially more hazardous in~     terms of invisibility, lack of control, where it enables communication with a broad range of~     people at any time and place.~      To explore deeper understanding of the magnitude and the impact of the bullying among~     adolescents in Taiwan to inform public policy and future health intervention programs may be~     beneficial not only to Taiwan but also to Asia as a whole. Many Asian countries now suffer~     the similar problems of bullying among adolescents, since these countries share similar~     characteristics of development (spread of internet, SNSs and smart phones).~      Goal and objectives: This study aims to explore Taiwanese adolescents' experiences,~     perceptions, opinions and mental health regarding cyberbullying and traditional bullying to~     inform the development of questionnaire in the quantitative phase of mixed methods study.~      Study design: A qualitative study design with in depth interviews will be adopted.~      Target population and study setting: Senior high school students will be recruited from~     Taipei city, Taiwan.~      Sample size and sampling method: Participants will be sampled by convenience sampling until~     thematic saturation is attained, probably around 50 students.~      Data collection: Face-to-face in-depth interview with semi-structured questionnaire will be~     used.~      Data analysis: All interviews will be voice-recorded, transcribed, analyzed by thematic~     analysis procedure. Analysis process will include familiarization, coding, searching for~     themes, reviewing the themes, defining, naming themes and writing up or weaving the analytic~     narrative. Triangulation and supervision will also ensure credibility and balance in the~     process.~   "
53947|NCT02860819|"~     This is a proof-of-concept study to define efficacy of gemcitabine, carboplatin and VELIPARIB~     (ABT-888) in patients with refractory germ cell tumors (GCTs). PARP proteins are involved in~     base excision repair (BER), one of the major DNA repair system in cells and PARP is~     overexpressed in testicular GCTs (TGCTs) compared to normal testis and data suggest that PARP~     overexpression is early event in TGCTs development. Patients with low PARP expression in~     primary tumour had non-significantly better OS compared to patients with high PARP expression~     (5-year OS 89.2% vs 78.7%; HR=0.50, 95% CI 0.21 to 1.17, p=0.12). The aim of this study is to~     evaluate PARP inhibitor VELIPARIB in combination with gemcitabine, carboplatin in patients~     with refractory germ cell tumors (GCTs).~   "
53948|NCT02860806|"~     The purpose of this study is to characterize the single-dose pharmacokinetic (PK) of single~     escalating intravenous (IV) doses of JNJ-63623872 administered as a continuous infusion; to~     evaluate the safety and tolerability of single escalating IV doses of JNJ-63623872~     administered as a continuous infusion; to characterize the single-dose PK of JNJ-63623872 of~     one selected dose administered as a continuous IV infusion at various durations and to~     characterize the single- and repeat-dose PK of JNJ-63623872 administered as a continuous~     infusion.~   "
53952|NCT02860754|"~     This prospective cohort study aims to determine whether the addition of the 6MWT to the RCRI~     score improves the risk prediction of postoperative cardiovascular outcomes after noncardiac~     surgery. In addition, this study will assess whether the patients' reported MET score~     corresponds to the determined MET score from the 6MWT distance completed.~   "
54065|NCT02859285|"~     The purpose of this research study is to learn about sexual function in postmenopausal women~     and to determine whether the use of topical clitoral application of estradiol improves~     women's libido, arousal, and orgasmic ability.~   "
53953|NCT02860741|"~     Rural African Americans are disproportionately impacted by social stressors that place them~     at risk for experiencing elevated depressive symptoms. This project will test the~     effectiveness of a culturally adapted behavioral activation intervention (REJOICE) for use~     within rural African American churches. Further, this project will gather data on strategies~     necessary to promote the successful implementation of this intervention within rural African~     American churches.~   "
53954|NCT02860728|"~     Structural changes in skeletal muscles of patients with chronic obstructive pulmonary disease~     (COPD) have been linked to impaired muscle function, reduced exercise capacity, and increased~     mortality associated with this disease. Muscle dysfunction also contributes to dyspnea~     intensity and the ability to sustain exercise, making aerobic exercise training intolerable~     at the intensity and/or volume required to achieve clinically important changes. Resistance~     training (RT) is an attractive exercise modality because it is efficacious and more tolerable~     initially. No work has examined whether a short-term RT program can reduce exertional~     symptoms and improve exercise tolerance (dyspnea and leg fatigue) in patients with COPD.~   "
53955|NCT02860715|"~     This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose study~     designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of GX-I7~     in healthy volunteers.~   "
53956|NCT02860702|"~     A randomized, blinded, controlled trial to evaluate growth velocity and clinical outcomes in~     infants with single ventricle physiology fed an exclusive human milk diet prior to, and~     throughout the post-operative period following, surgical repair. Human milk is defined as~     expressed human milk or donor milk and its derivatives, human milk-based fortifier and human~     milk caloric fortifier.~      The study hypothesis is that infants fed an exclusive human milk diet will have short and~     long term benefits, with improved wound healing, growth, and neurodevelopmental outcomes~     while reducing episodes of feeding intolerance and necrotizing enterocolitis (NEC).~   "
53957|NCT02860689|"~     Objective: To analyze the association between sexual function of men with spinal cord injury~     with possible predictive factors for dysfunction.~   "
53958|NCT02860676|"~     The purpose of the study is to investigate the safety of the investigational drug called~     cirmtuzumab when given for a duration of 6 to 12 months. Cirmtuzumab is a type of drug called~     a monoclonal antibody. This drug is designed to attach to a protein called ROR1 that is on~     the surface of chronic lymphocytic leukemia (CLL) cells. This blocks growth and survival of~     the CLL cells. ROR1 is rarely expressed on healthy cells so this drug should target the~     cancer cells. Cirmtuzumab is considered experimental because its use is not approved by~     United States (US) Food and Drug Administration (FDA).~      Although there is evidence from tests on laboratory animals that cirmtuzumab can decrease the~     number of CLL cells, the investigators do not know if this will work in humans. Therefore,~     the goal of this study is to see if cirmtuzumab is safe and tolerable in study participants~     when given for a duration of 6 to 12 months.~   "
53959|NCT02860663|"~     Background: Dietary intake of vitamin D includes vitamin D3 (VitD3), 25-hydroxyvitamin D3~     (25OHD3) and vitamin D2 (VitD2). However, the bioactivity of the different species is~     currently not scientifically established.~      Objective: The aim of this study was to test the hypothesis that VitD3, 25OHD3 and VitD2~     affected vitamin D status equally in humans and if rejected, to estimate the difference in~     activity.~      Design: This study was designed as a 3 x 6 weeks (with 4 weeks run-in) double-blinded~     randomized cross-over study with 12 young, apparently healthy male volunteers and was~     performed during wintertime at 55 degree N. during the 4 weeks run-in period all volunteers~     received 10 ug/d VitD3 in order to achieve steady-state in vitamin D status. During the 3x6~     weeks intervention periods the subjects received 10 ug/d VitD3, 10 ug/d 25OHD3 or 10 ug/d~     VitD2 in random order. Content of vitD3, VitD2, 25OHD3 and 25-hydroxyvitamin D2 (25OHD2) in~     serum were quantified my LC-MS/MS using 0.1 mL serum.~   "
53960|NCT02860650|"~     The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and~     Ad26.Filo as heterologous prime-boost vaccine regimens in healthy adult participants.~   "
53961|NCT02860637|"~     In addition to the motor and sensory functions, sexual function changes after spinal cord~     injury and is considered one of the most common problems, ranging from a decrease in sexual~     desire to disturbances of erection, orgasm and ejaculation.~      Objective: To assess the impact of the complexity of traumatic spinal cord injury in male~     sexual function.~   "
53962|NCT02860624|"~     This study is designed to evaluate the efficacy and tolerability of ilaprazole relative to~     that of esomeprazole in healing erosive esophagitis and resolving accompanying symptoms of~     GERD.~   "
53963|NCT02860611|"~     Recent reports show increased prevalence of obesity in patients with type 1 diabetes (T1DP)s~     while some studies stated that patients with type 2 diabetes (T2DPs) have islet cell~     auto-antibodies. These results raise the question of a common pathway in T1DM and T2DM via an~     association with T helper cells. In this study investigators aimed to investigate the~     difference between T helper 1 (Th1) cytokines levels in T1DPs, T2DPs and healthy subjects.~      The study included 114 T1DPs on insulin treatment, 35 newly diagnosed T2DPs who had not used~     oral antidiabetics but insulin before and 31 healthy subjects (CG).~      Serum interferon gamma (IFN-γ), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α)~     levels were measured using ELISA method. Serum levels of those cytokines in T1DPs were~     compared with those in T2DPs and controls.~   "
53964|NCT02860598|"~     Anemia concerns a lot of patients with cancer and affects their quality of life (QOL).~     Numerous studies in oncology have demonstrated the benefit of erythropoiesis-stimulating~     agents (ESA) in the treatment of anemia. ESAs allow the improvement of QOL,of the hemoglobin~     level (Hb) and is a validated alternative to transfusion.~      However, in hematology, if there are some specific recommendations for the use of ESAs in~     lymphoid pathology, there are none for myeloid disorders and in the context of autografts and~     allogeneic hematopoietic stem-cell transplantation (HSCT). Thus, the investigators are in~     particular interested in both indications: treatment of anemia in acute myeloid leukemia~     (AML) patients treated with chemotherapy, and the in patients receiving a myeloablative or a~     non-myeloablative conditioning before allogeneic HSCT, whatever type of donor and cell~     source.~   "
53965|NCT02860585|"~     The objective of this study was to evaluate the outcome of patients affected with different~     subtypes of metastatic breast cancer following treatment with high-dose chemotherapy and~     autologous haematopoietic progenitor cell transplantation.~   "
53966|NCT02860572|"~     Background: After hypotension, oliguria (urine output less than 0.5 mL/kg/h) was the most~     common trigger to administer fluid bolus in a multinational practice survey in intensive~     care. The effect of fluid bolus on cardiovascular variables can be very short-lived among~     patients in shock suggesting that fluid boluses in the optimization phase are unlikely to~     improve patient-centered outcomes. Moreover, a growing body of evidence suggests a poor renal~     response to fluid bolus.~      Objective: To investigate, whether fluid bolus - as a standard of care - improves urine~     output in oliguric patients compared to a non-interventional follow-up approach without fluid~     bolus.~      Design: Investigator-initiated, open, randomized, controlled study~      Interventions:~        1. Intervention group - follow-up without intervention~        2. Control group - fluid bolus (500mL of balanced crystalloid over 30 minutes)~      Randomization: 1:1 stratified according to the site, presence of acute kidney injury, and~     sepsis~      Trial size: 120 patients randomized in 3 ICUs~   "
53967|NCT02860559|"~     This is a study of stem cell transplantation with TBX-1400 in pediatric subjects with severe~     combined immunodeficiency (SCID).~      The donor cells are exposed to a protein that has been shown in the laboratory to improve the~     ability of the donor cells to make blood and immune cells after transplant. Exposure of the~     donor cells to this protein does not modify the genes in the cells in any way.~      This study has two goals. The first goal is to find out if transplant with TBX-1400 is safe.~     The second goal is to find out what effects TBX-1400 stem cells have on time to engraftment~     in pediatric subjects with SCID. The study hypothesis is that TBX-1400 cells will shorten the~     time to immune reconstitution after transplant.~   "
53968|NCT02860546|"~     A Phase 2 Study with Safety Lead-in, Evaluating TAS-102 Plus Nivolumab in Patients with~     Microsatellite Stable Refractory Metastatic Colorectal Cancer~   "
53969|NCT02860533|"~     The iPARR DELTA BP Study is designed to evaluate whether a new smartphone app using the~     photoplethysmography signal of the inbuilt camera can measure blood pressure (BP)~     fluctuations with sufficient correlation compared to the goldstandard oscillometric BP~     measurements. Investigators will recruit patients who are scheduled for a routine treadmill~     stress test and assess their blood pressure before and right after the test with the~     smartphone app and the standard BP measurements on the opposite upper extremity. Pronounced~     BP fluctuations are encountered during vigorous activities. The primary endpoint of the iPARR~     DELTA BP Study is the correlation of the absolute difference of subsequent measurements~     between both techniques. If the relative chances of BP fluctuations are sufficiently assessed~     with this new device, BP fluctuations could be monitored continuously after calibration.~   "
53970|NCT02860520|"~     The retinitis pigmentosa (RP) are genetic conditions that cause retinal degeneration leading~     to severe low vision and is the leading cause of consultation in reference centers dedicated~     to the ophthalmic genetics. These rare diseases are characterized by a triple heterogeneity~     (clinical, genetic and molecular), which made them unreachable by traditional molecular~     diagnostic sequencing technology by the large number of genes to be tested (> 190).~      The advent of high-throughput sequencing (NGS) and targeted capture has opened unexpected~     possibilities of investigation and ultimately to improve the care of patients. This project~     aims to study the genetic and molecular epidemiology of an interregional french (grand EST)~     cohort of patients. Patients receive a detailed retinal phenotype (visual acuity, visual~     field, photographs of the fundus and ERG). Their DNA will be analyzed by NGS targets the 190~     known genes (https://sph.uth.edu/retnet/).~      This research will provide a molecular epidemiological cohort study compared to prior~     publications on the frequency of genes involved. The benefit for patients is important to:~     establish a mode of transmission of the disease and optimize genetic counseling (currently~     very empirical); establish phenotype-genotype correlations in the French population (very few~     studies to date) and from the data of international literature; identify patients likely to~     be included in future therapeutic protocols of research; identify patients with significant~     potential for future projects to identify new genes.~      The primary purpose of the protocol is to use high throughput sequencing to identify~     pathogenic variants in genes involved in RP.~      The secondary purposes will be the following:~        -  Determining the diagnostic yield~        -  Study the genotype-phenotype correlation.~      The secondary purposes will be the following:~        -  Determining the diagnostic yield~        -  Study the genotype-phenotype correlation~   "
53971|NCT02860507|"~     The purpose of this study is to evaluate the efficacy of Sugammadex in rapidly reversing deep~     neuromuscular blockaded (induced by rocuronium)~   "
53972|NCT02860494|"~     Tuberous sclerosis complex (TSC) is a rare genetic multisystem disorder characterized by the~     development of hamartomas in several organs (e.g. brain, heart, kidney, liver, lung), and~     skin in more than 90% of cases. Facial angiofibromas (FA), present in about 80% of patients,~     are a stigmatizing hallmark of the disease. Everolimus could be a candidate for use as a~     topical formulation to treat FA. This adaptive seamless Phase II/III study primary objective~     is to determine the dose of topical everolimus for treatment of FA and evaluate the efficacy~     and safety of topical everolimus versus placebo in patients with angiofibromas.~   "
53973|NCT02860481|"~     FRACTal study is the first exploration of detection of FSHR as a blood biomarker for the~     diagnosis of cancer.~      A first cohort will explore several common (e.g. breast, prostate) or rare (e.g. uveal~     melanoma) cancers, that are frequently treated at Institut Curie. This first cohort will~     include n=10 patients per histological type except for breast cancer (n=50). 100 patients are~     expected in this cohort.~      A second cohort will explore the more promising histological type (if any) in term of~     incidence of detection. 100 patients are expected for this second cohort.~   "
53974|NCT02860468|"~     The compliance of participants in cranberry related clinical trial is poor due to the~     bitterness and astringency of cranberry products. There is a pressing need for an effective~     approach to verify participant compliance. The PLS-DA (Partial Least Squares Discriminant~     Analysis) /OPLS-DA (Orthogonal Partial Least Squares Discriminant Analysis) models~     established from the investigator's previous study provide an opportunity to identify~     cranberry juice consumers. In this blinded, placebo-controlled, cross-over study,~     investigators hypothesize that the established statistical models of PLS-DA (Partial least~     squares discriminant analysis) /OPLS-DA (Orthogonal partial least squares discriminant~     analysis) can identify cranberry juice consumers and non-consumers by analyzing the~     metabolomic changes in blood and urine among young women. In order to further explore the~     function of cranberry, microbiome profile will also be compared between cranberry juice~     consumption and placebo consumption after long-term treatment. Another comparison of~     metabolomic changes between short-term treatment and long-term treatment will be made to~     further identify candidate biomarkers of cranberry consumption and explore the correlation~     between acute effects and chronic effects of cranberry.~   "
53998|NCT02860156|"~     This is a multicenter clinical trial of a cross section of HIV+ patients with and without~     diastolic dysfunction. Approximately 200 HAART-treated virally suppressed HIV+ subjects (100~     HIV+/DD+ & 100 HIV+/DD-) will be enrolled. This study will evaluate biomarkers, phenomapping,~     metabolomics, cMRI, echocardiography to determine characteristics unique to this patient~     population.~   "
53975|NCT02860455|"~     The RAD-57 pulse CO-oximeter is a lightweight device allowing non-invasive measurement of~     blood carboxyhemoglobin. Previous studies comparing RAD-57 measurements (SpCO) to standard~     laboratory blood gas analysis (COHb) have reported contradictory results.~      the RAD-57 pulse CO-oximeter could be useful as a first-line screening test for acute CO~     poisoning, enabling rapid detection and management of patients with suspected CO poisoning in~     the prehospital emergency setting This study assesses the diagnostic value of pulse~     CO-oximetry, comparing SpCO to standard laboratory blood measurement for prehospital~     management of patients with suspected carbon monoxide (CO) poisoning.~   "
53976|NCT02860442|"~     The overall goal for the study is to test the efficacy of a smartphone app which includes an~     alcohol brief intervention (SP-BI) versus an Enhanced Usual Care (EUC) condition for National~     Guard members in the State of Ohio who meet criteria for at-risk drinking in the previous 3~     months. The main hypothesis is that those in the SP-BI group with have reduced frequency and~     intensity of at-risk drinking and fewer binge drinking episodes.~   "
53977|NCT02860429|"~     The clinical trail of Cinobufacini injection combined with Oxaliplatin regimen on~     gastrointestine carcinoma.This trail is randomized controled.Patients are diagnosed~     gastrointestinal cancer based on pathology or cell biology.They are randomized into 2~     groups:both groups receive Oxaliplatin regimen.The treatment group receives Cinobufotalin~     20ml mixed with 5% Glucose injection 500ml from the first day of chemotherapy until seven~     days in addition to the chemotherapy.The control group only receive the same chemotherapy~     with the treatment group.Both group have the same adjuvant therapy.Mainly to study of~     oxaliplatin into Cinobufacini injection leads to the influence of the peripheral nerve~     toxicity.Clinical evaluation includes neural electrophysiological test,chemotherapy drug~     toxicities,quality of life(QOL),etc.Blood biochemistry tests mainly include inflammatory~     cytokines,peroxidase reaction,immune cell number ratio and stress hormone,etc.~   "
53978|NCT02860416|"~     The purpose of this study is to collect additional Investigational cognitive tasks and~     additional clinical data for subjects tested with ElMindA's Brain Network Activation (BNA™).~   "
53979|NCT02860403|"~     Single center, pilot study, to evaluate the influence of Motor Imagery (MI) on functional~     rehabilitation and cerebral plasticity through the qualitative and quantitative mental~     practice approach. For this, the investigators will use magnetoencephalography (MEG) but also~     physiological and behavioral indicators developed by the Laboratoire de la Performance~     Motrice, Mentale et du Matériel (P3M) of Université Claude Bernard Lyon 1 and its partners.~   "
53980|NCT02860390|"~     This is a Comparison Effectiveness Research (CER) study in a population of 13 to 40 year-old~     individuals with persistent asthma comparing differing levels of texting interventions with~     each other and with a usual care group. The two texting interventions include 1) texting only~     the individual with asthma and 2) texting the individual with asthma and an important person~     in that individual's life such as a parent or spouse. These two texting groups will be~     compared to a group receiving usual asthma care at Denver Health.~   "
53981|NCT02860377|"~     Mother spend a large amount of time with their children. It is assumed that mother~     contributes to their neurological development not only with visual stimuli, but also with~     auditory stimuli. A recent study revealed that prefrontal cortex can be activated in response~     to the self-name being spoken by the mother than by a stranger. Therefore, investigators~     suppose that recorded maternal voice can stimulate the pediatric patients and thereby fasten~     the emergence from general anesthesia.~   "
53982|NCT02860364|"~     Hypothermic circulatory arrest is an important surgical technique, allowing complex aortic~     surgeries to be performed safely. Hypothermic circulatory arrest provides protection to~     cerebral and visceral organs, but may result in longer cardiopulmonary bypass times during~     surgery, increased risks of bleeding, inflammation, and neuronal injury. To manage these~     consequences, a trend towards warmer core body temperatures during circulatory arrest has~     emerged. This trial will randomize patients to either mild (32°C) or moderate (26°C)~     hypothermia during aortic hemiarch surgery to determine if mild hypothermia reduces the~     length of cardiopulmonary bypass time and other key measures of morbidity and mortality.~   "
53983|NCT02860351|"~     In the present study, the cross-sectional area of subclavian vein, the distances of~     subclavian vein ~ subclavian artery and subclavian vein ~ pleura are assessed in different~     head positions (neutral, rotation to ipsilateral or contralateral sides) in spontaneous~     breathing adults.~   "
53984|NCT02860338|"~     This retrospective study is a more extensive, confirmatory analysis of the cognitive and~     functional outcomes initially seen in 2 groups of MCI/dementia patients in Springfield, MA~     and compares specialized dementia care and a comprehensive treatment approach versus usual~     care delivered in a non-specialist setting.~      The first group of patients (n= 328) was seen by a dementia specialist, who utilized a~     standardized assessment and treatment protocol (CNS). This included comprehensive~     identification and treatment of hypoxia, sleep-disorders, and other cognitively-impairing~     metabolic conditions as well as maximally- dosed FDA-approved medications for dementia,~     depression, and PBA.~      The second group of patients (n= 280) was seen by non-dementia specialists in the community~     and received usual care which did not include comprehensive assessment or treatment of~     underlying metabolic derangements or maximal utilization of currently available medications.~      This study, evaluating date from a larger cohort (n>800) of specialist-treated~     cognitively-impaired patients, will further examine the hypothesis that a comprehensive~     dementia treatment protocol yields cognitive stabilization and/or improvement using already~     available dementia drugs when compared with usual community care.~   "
53999|NCT02860143|"~     A. Determine if Respiratory Volume Monitor (RVM) can be used during procedural sedation to~     adequately monitor patient's respiratory status as compared to capnograph Aims B. Compare the~     time of capture of respiratory events (depression, arrest, etc…) on both the RVM and the~     capnograph C. Compare the incidence of missing or poor quality readings between the RVM and~     the capnograph D. Compare RR readings between the RVM and the capnograph (during periods with~     adequate data quality on both devices) E. If RMV can identify respiratory obstruction.~     Capnography~   "
54000|NCT02860130|"~     The purpose of this research is to determine if an investigational new drug solution called~     Prismocitrate 18 lengthens extracorporeal circuit life in patients treated with continuous~     renal replacement therapy (CRRT). Patients who receive CRRT treatment with Prismocitrate 18~     as the anticoagulant will be compared to patients who receive CRRT treatment with no~     anticoagulation.~   "
53985|NCT02860325|"~     Mechanical respiratory support of preterm neonates with respiratory distress syndrome (RDS)~     and/or apnoea of prematurity (AOP) might be associated with adverse effects due to positive~     pressure (barotrauma), excessive gas delivery (volutrauma) or inadequate volume~     (atelectrauma). Asynchrony between patient efforts and ventilator support increases patient~     discomfort, favouring fighting the machine, and increases the risk of air trapping and lung~     overdistension even in patients with non-invasive ventilation (NIV).~      Recently, a new modality of synchronization has been available for pediatric and neonatal~     use: the neurally adjusted ventilatory assist (NAVA), which uses the diaphragmatic electrical~     activity (Edi) as a signal to start the rise in pressure of the ventilator, and to adjust the~     tidal volume and the inspiratory time (cycling off) to the patient needs, breath by breath.~      The aims of this study are to know whether NIV-NAVA compared to unsynchronized modalities~     (nCPAP/nIPPV), in infants born < 32 weeks GA with respiratory distress syndrome or requiring~     prophylactic NIV (immaturity, apnoea) reduces systemic inflammation, measured by serum~     cytokines concentration, reduces the need for oxygen and respiratory support, and if it~     increases the probabilities of survival without bronchopulmonary dysplasia (BPD).~   "
53986|NCT02860312|"~     Patients on chronic hemodialysis present severe physical dysfunctioning associated with a~     significant reduction of their muscle mass. These two parameters are associated with~     increased morbidity and mortality along with deconditioning and poor quality of life. There~     are several studies- usually short term, single center uncontrolled and underpowered- that~     have shown a significant improvement of the physical, metabolic and dialytic parameters.~      There are only few studies that have measured the impact of a long term intradialytic~     exercise intervention on a supervised manner. This is a multi-center controlled study~     examining the effects of intradialytic cycling on parameters of physical functioning, body~     composition, cardiovascular and nutritional status, immunological status and quality of life~     in a group of clinically stable hemodialysis patients~   "
53987|NCT02860299|"~     In the VERROUREA study, there were two cases of an abnormal increase in TCA. In theory no~     leakage of the lock into the bloodstream should have been seen. Lock leakage could have~     particularly serious, and especially clinical, repercussions in these patients who already~     have a high risk of haemorrhage given the numerous associated comorbidities. The aim of this~     study is to investigate the leakage of locks into the bloodstream by measuring, before and~     after injection of the lock, the evolution of haemostasis tests and calcaemia. The findings~     will complete safety data already collected in the VERROU REA study.~   "
53988|NCT02860286|"~     This is a Phase 2, multicenter, open-label, 2-part, single-arm, 2-stage study of tazemetostat~     800 mg two times a day (BID) administered orally. Screening of subjects to determine~     eligibility for the study will be performed within 21 days of the first planned dose of~     tazemetostat.~      In Part 1, 12 subjects with relapsed or refractory malignant mesothelioma regardless of BAP1~     status will be treated and undergo pharmacokinetics (PK) blood sample collection after a~     single tazemetostat 800 mg.~      Part 2 will include subjects with BAP1-deficient relapsed or refractory malignant~     mesothelioma.~      Treatment with tazemetostat will continue until disease progression, unacceptable toxicity or~     withdrawal of consent, or termination of the study. Response assessment will be evaluated~     after 6 weeks of treatment and then every 12 weeks thereafter while on study.~   "
53989|NCT02860273|"~     In this study the investigators will determine whether the use of High Flow Nasal Cannula~     Oxygen during test enhances exercise performance in COPD patients on a treadmill.~   "
53990|NCT02860260|"~     The aim of this study is to show for the first time that treatment with intravenous~     fibrinolysis using rt-PA in patients with recent ischemic stroke is accompanied by increases~     in circulating levels of BDNF, which may reflect an increase in BDNF synthesis in the brain.~      The analysis of the recovery of functional and cognitive abilities as well as mood at 3~     months will allow us to study the impact of BDNF on these parameters. Thus, depending on the~     results obtained, circulating BDNF could serve as an early marker of these.~   "
53991|NCT02860247|"~     This study aims at determining within a short time (<3h) the susceptibility to clinical~     isolates of E. coli to the major antibiotics directly from positive blood cultures.~   "
53992|NCT02860234|"~     This study is designed to test the efficacy of tailored operative or non-operative management~     (NOM) for MRI defined low-risk rectal cancer following neoadjuvant intensity modulated~     radiotherapy with concurrent capecitabine plus consolidation CapeOX. The main purpose of this~     study is to increase organ-preservation rate for low-risk rectal cancer patients.~   "
53993|NCT02860221|"~     The purpose of this study is to compare the blood loss of intravenous and topical~     administration of low dose epinephrine plus combined administration of intravenous and~     topical tranexamic acid for primary total knee arthroplasty.~   "
53994|NCT02860208|"~     The objective of this prospective clinical study was to evaluate the 3-year outcomes of~     anti-infective surgical treatment of peri-implantitis when a regular supportive peri-implant~     therapy (SPIT) programme was followed.~   "
53995|NCT02860195|"~     A non invasive transdermal sensor device was developed by the Im2Np laboratory to determine~     the presence of vapor of alcohol in insensible perspiration.~      One of possible application would be a continuous and non invasive monitoring of drinking~     behavior. To investigate the validity of this method, it's necessary to compare Transdermal~     Alcohol Concentrations results obtained by this new device with Blood Alcohol Concentrations~     and breath Alcohol Concentrations provided by reference methods.~      The purpose of this study is to identify the kinetic of alcohol concentration in blood,~     exhaled air and sweat after alcohol ingestion.~   "
53996|NCT02860182|"~     Acute type A aortic dissection is a frequent (3 cases per 100 000 people per year) and severe~     (spontaneous mortality 70%), needing an emergency surgical treatment. Surgical outcomes have~     improved with the development of surgical techniques, but the postoperative mortality remains~     high (15-30% at 30 days). Endovascular approach with the deployment of endoprosthesis sealing~     the proximal intimal tear is an attractive minimally invasive technique, which can represent~     an alternative to surgical repair especially in high risk patients.~   "
53997|NCT02860169|"~     This study aim to adapt and test a novel indication of motivation in participants with cold &~     flu using the Picture Surfing Task (PST). The purpose of this task, in both healthy~     participants and those with cold & flu, will be to provide a measure of: 1) change in general~     motivation, 2) change in cold and flu-specific motivation, and 3) any change in general~     tendency to exert force to serve as a control.~   "
54003|NCT02860091|"~     The main objective of this proposed investigation is to evaluate blood ropivacaine~     concentrations in infants and toddlers following the initiation of, and over the course of,~     continuous paravertebral nerve blockade using ropivacaine infusion for postoperative pain~     control following esophageal atresia repair procedures that include posterior tracheopexy.~      Continuous paravertebral infusion of ropivacaine is the current standard of practice for this~     surgical population at the investigators' institution and, as such, this study does not aim~     to alter the current standard clinical care received by participants but rather evaluate the~     blood concentrations of ropivacaine as it is routinely used.~   "
54004|NCT02860078|"~     Qualitative and quantitatively evaluate the pain control and incidence of adverse effects in~     patients undergoing corticosteroid infiltration and local anesthetic through sacral epidural~     puncture with ultrasound assistance or isolated use of fluoroscopy to aid puncture and~     location of the sacral epidural space. A group will be submitted to epidural corticosteroid~     infiltration associated with local anesthetic with the use of fluoroscopy for locating the~     sacral epidural space, which is currently the gold standard for this technique, while in~     another location group will be held with the use of ultrasound.~   "
54005|NCT02860065|"~     The purpose of this study is to compare the effect of low and high dose CPC-201 on brain~     function including cerebral acetylcholinesterase (AChE) activity measured by positron~     emission tomography (PET).~   "
54006|NCT02860052|"~     This is a phase 2, multi-center, double-blind, randomized, vehicle-controlled study to be~     conducted in approximately 170 non immunocompromised adult subjects with interdigital tinea~     pedis. Subjects will apply the investigational product (IP) (SB208 or Vehicle Gel) to the~     interdigital areas and all affected and immediate surrounding areas of one or both feet once~     daily for 2 weeks, followed by a 4-week post-treatment observation period.~   "
54007|NCT02860039|"~     This phase II randomized trial studies how well high dose flu vaccine works in treating~     children who have undergone done stem cell transplant. Higher dose flu vaccine may build a~     better immune response and may provide better protection against the flu than the standard~     vaccine.~   "
54008|NCT02860026|"~     This clinical trial will compare the growth and tolerance of infants who consume an~     investigational cow's milk-based infant formula to those who consume a marketed cow's~     milk-based infant formula through approximately 4 months of age.~   "
54009|NCT02860013|"~     There are two main aims in this study. The first objective is to evaluate whether a~     particular telehealth solution, in addition to standard treatment and care, lead to a~     significant decrease in the mortality and an increase in health related quality of life for~     patients suffering from Heart Failure that may benefit from telehealth compared with only~     standard treatment and care. The second objective is to examine the additional costs of the~     telehealth solution and assess whether this solution is a cost-effective way to care for~     patients with Heart Failure across patients and municipality districts.~      It is hypothesized that telehealth care will increase patients quality adjusted life years~     compared to usual practice, since no difference in mortality and a higher health related~     quality of life is expected. Furthermore, it is hoped that there will be a 30% reduction in~     the number of admissions and readmissions to hospitals and a 30% reduction in the number of~     outpatient visits resulting in fewer costs for hospitals. However, it is uncertain as to~     whether these savings are offset by other costs such as more visits to general practitioners,~     community care or the implementation costs.~   "
54010|NCT02860000|"~     This phase II trial studies how well alisertib with or without fulvestrant works in treating~     patients with endocrine-resistant breast cancer that has spread to other places in the body.~     Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Hormone therapy using fulvestrant may fight breast cancer by blocking the use of~     estrogen by the tumor cells or reducing the amount of estrogen made by the body. Giving~     alisertib with or without fulvestrant may be better in treating patients with breast cancer.~   "
54011|NCT02859987|"~     Peripherally Inserted Central Catheter (PICC) are intravascular devices used on patients~     undergoing IV therapy. Insertion of these catheters can be achieved either by using the~     anatomical landmarks for the veins or using ultrasound guidance. The guidelines recommend the~     use of ultrasound guidance for central venous access catheterization to facilitate central~     venous cannulation (CVC) and to reduce the risk of complications, but the scientific evidence~     is limited and heterogeneous.~      This is a prospective randomized clinical trial in adults patients requiring peripherally~     inserted central catheter (PICC) placement for intravenous therapy.~      The principal aim of this randomized clinical trial is to evaluate the effectiveness of~     ultrasound-guidance technique for successfully peripherally central venous catheterisation in~     the first attempt versus landmark method, in the context of PICC cannulation.~      Patients are randomized (1:1) in two groups: Control arm (landmark technique) versus~     Experimental group (ultrasound guidance technique). In order to avoid expected biases the~     investigators stratified the cases by difficulty for venous cannulation. Crossover was~     allowed if catheterisation could not be reached after two unsuccessful venipunctures, to~     prevent suffering of the patients and troubles in its care.~   "
54012|NCT02859974|"~     Paradoxical Vocal Fold Motion Disorder (PVFMD), otherwise known as vocal cord dysfunction~     (VCD) is a laryngeal breathing disorder that has several potential causes. In some~     individuals, exertion is the predominant trigger. PVFMD can present like an asthma attack,~     but asthma medication is ineffective in treating it. The effects of untreated PVFMD can be~     devastating, leading to harmful, invasive, and ineffective treatments over a period of years.~     Numerous anecdotal reports indicate that several behavioral techniques, may be surprisingly~     effective and even curative. However, data are lacking. The form of respiratory retraining~     technique tested in the current study educates people with PVFMD about breathing and teaches~     them a number of breathing exercises specially designed to restore normal breathing patterns.~      This case series study will use a dyspnea perception questionnaire, patient daily logs, and~     physiological measurements of heart rate and breathing to examine whether this form of~     therapy can improve exertion-induced PVFMD symptoms.~   "
54078|NCT02859116|"~     The purpose of this study is to help scientists understand how the gut senses ingested~     nutrients and what kind of processes take place for their absorption in order to establish~     the association with diabetes and other metabolic diseases Scientists need human specimens to~     study.~   "
98846|NCT02273427|"~     food effect, relative bioavailability, pharmacokinetics, safety and tolerability~   "
54013|NCT02859961|"~     This study is a Phase 2b/3, multi-center study designed to evaluate the efficacy, safety, and~     tolerability of the strategy of shifting clinically stable patients receiving suppressive~     combination antiretroviral therapy to PRO 140 monotherapy and maintaining viral suppression~     for 48 weeks following study entry.~      Consenting patients will be shifted from combination antiretroviral regimen to weekly PRO 140~     monotherapy for 48 weeks during the Treatment Phase with the one week overlap of existing~     retroviral regimen and PRO 140 at the beginning of the study treatment and also one week~     overlap at the end of the treatment in subjects who do not experience virologic failure.~   "
54014|NCT02859948|"~     Patients will receive oral SKLB1028 for 28 days to study the side effects, tolerability and~     best dose for treating relapsed or refractory acute myeloid leukemia With FLT3 Mutations.~   "
54015|NCT02859935|"~     The purpose of this randomized controlled intervention study at the STI outpatient clinic of~     Amsterdam is to answer the following questions : Does a personalised behaviour intervention~     comprising of targeted in-depth screening on mental health problems and drug use and, in case~     identified, subsequent linkage to care increase help seeking behaviour, and decrease risk~     behaviour in MSM who are at high risk for STIs and HIV?~   "
54016|NCT02859922|"~     The study compared the Laryngeal Tube Suction (LTS-D) Disposable with the Supreme Laryngeal~     Mask Airway (SLMA) during spontaneous ventilation. The investigators hypothesized that the~     LTS-D and the SLMA perform similarly during spontaneous ventilation despite differences in~     their structural design.~   "
54017|NCT02859909|"~     The main purpose of this study is to assess the efficacy and safety of BT595 in adult~     subjects with chronic ITP. The primary objective of this study is to determine the rate of~     subjects with a response. A response is defined as a platelet count of ≥30×10^9/L and at~     least a 2 fold increase of the baseline count, confirmed on at least 2 separate occasions at~     least 7 days apart, and the absence of bleeding. The secondary objectives of this study, in~     addition to further efficacy assessments, are to evaluate the safety of BT595.~   "
54018|NCT02859896|"~     Primary Objective:~      Evaluate the effect of Hectorol® capsules in reducing elevated levels of intact parathyroid~     hormone (iPTH).~      Secondary Objectives:~        -  Evaluate the safety profile of Hectorol® capsules versus Rocaltrol® (calcitriol)~          capsules.~        -  Determine the pharmacokinetic profile of 1,25-dihydroxyvitamin D2 after administration~          of Hectorol®.~   "
54019|NCT02859883|"~     The monitoring and prognosis of patients with familial polyposis adenomatous rests on~     analysis of the transitional mucosa at the anal margin and especially on the tracking,~     characterization and resection of lesions of dysplasia type of high grade at the duodenal~     level, after total proctocolectomy. Currently, endoscopes with axial or lateral vision are~     used. The FUSE technology allows the simplification or even the improvement of patient~     surveillance with a 245° vision (versus150° in case of classical gastroscope). The use of a~     second screen to enlarge the field of view may allow both analysis of duodenum and the main~     and accessory papilla with one single endoscope and to decrease the number of omitted lesions~     .~   "
54020|NCT02859870|"~     The coloscopy is considered as the gold standard for screening and resection of colorectal~     adenomas. However the literature reports that the rate of omitted adenoma is still high (24~     to 41%). The development of the FUSE system (Endochoice, USA) allows a larger field of view~     with a projection onto 3 screens (330° vision). A pilot study and a randomized multicentre~     has demonstrated the feasibility with a significant improvement of the rate of detected~     adenomas. This first study in France concerning this technology has the objectives to~     demonstrate the feasibility in France, the safety and to compare the rate of detected~     adenomas with data of the literature.~   "
54021|NCT02859857|"~     The objective of this study is to characterize the safety profile and determine the maximum~     tolerate dose (MTD) of BXQ-350, when given as a single agent at escalating doses, according~     to the investigational product (IP) related dose-limiting toxicities (DLTs) in patients with~     advanced solid tumors. Secondarily to assess the preliminary antitumor activity of BXQ-350 in~     solid tumors and recurrent high grade gliomas.~   "
54022|NCT02859844|"~     Many patients with neurological diseases suffer from neurogenic lower urinary tract~     dysfunction (NLUTD), which often severely impairs quality of life, due to urinary urgency~     with or without incontinence and voiding dysfunction. In addition, the upper urinary tract~     may be jeopardized because of high intravesical pressure caused by detrusor overactivity with~     concurrent detrusor-sphincter-dyssynergia and/or low bladder compliance. The treatment of~     NLUTD is a challenge since conventional conservative therapies often fail and more invasive~     treatments such as intradetrusor onabotulinumtoxinA injections, bladder augmentation and~     urinary diversion have to be considered. Neuromodulation therapies including tibial nerve~     stimulation (TNS) may be alternative non-invasive treatment options. Indeed, TNS is an~     effective and safe treatment for idiopathic overactive bladder proven in randomized~     controlled trials (RCTs), but its value in neurological patients is unclear. In a recent~     systematic review, the investigators found evidence that TNS might become a promising~     treatment option for NLUTD, however, more reliable data from well-designed RCTs are urgently~     needed to reach definitive conclusions. However, the investigators study will be the first~     adequately sampled and powered, randomized, placebo-controlled, double-blind trial assessing~     transcutaneous TNS (TTNS) for NLUTD. This trial will provide significant insights into the~     efficacy of TTNS in patients suffering from NLUTD and in the case that this treatment is~     really effective in the neurological population, the investigators findings would completely~     revolutionize the management of NLUTD in daily clinical practice. Moreover, this~     interdisciplinary trial will relevantly influence the neurological and urological approach in~     the management of NLUTD promoting future collaborative projects improving patients' medical~     care and underlying the pioneering role of Switzerland in the rapidly developing and~     ambitious research field of neuro-urology.~   "
54023|NCT02859831|"~     Fusarium are microscopic filamentous fungi that live as saprobiontics in outside~     environments. They are found in the soil, the air, in water and on numerous plants. The~     frequency of fusariosis is currently increasing and Fusarium-related mycoses are the 3rd most~     frequent invasive mycoses. Most cases have been reported in the United States, in France, in~     Italy and in Brazil. A few epidemiological studies have shown the role of water in the~     appearance of mycoses in highly immunodepressed patients. Few studies have focused on the~     role of water in the transmission of mycoses in hospitals. The aim of this prospective study~     is to describe, in time and pace, the contamination by Fusarium sp. in the water of two~     different hospitals (Dijon, Nancy), by taking into account factors such as seasons and major~     works (reconstruction of a hospital). In each hospital, one reconstruction site will be~     compared with a site not under reconstruction (control).~      Water samples will be taken from the rooms of hospitalized patients.~   "
54089|NCT02858973|"~     This is randomized, double-blind, placebo-controlled, multiple ascending dose study of Q203~     in healthy volunteers conducted at one study center in the United States~   "
54024|NCT02859818|"~     Introduction: Therapeutic Patient Education (TPE) is the key of the interdisciplinary~     management of type 1 diabetes for adolescents, favoring their adherence and improving their~     quality of life and metabolic control. Six pediatric diabetes teams have engaged in action~     research to build a regional ETP program based on social cognitive theory of Bandura,~     assuming that the learning strategies of theory, applied in ETP program, should strengthen~     self-efficacy of adolescents with type 1 diabetes, which could induce an improvement~     behaviors adherence, quality of life and physiological profile of participants about 6 months~     post-inclusion in the program.~      Aims: The main objective is to describe the evolution over 6 months of self-efficacy in a~     cohort of adolescents with type 1 diabetes who followed a therapeutic education program based~     on social cognitive theory of Bandura in region PACA (ETPACAP program). Secondary objectives~     are to describe the evolution of 6 months of glycemic control, behavior of adherence, quality~     of life and other components of social cognitive theory for this population, to explore the~     effects of socio-cognitive profile on adherence, quality of life and glycemic control among~     adolescents with type 1 diabetes followed this program.~      Method: A prospective multicenter cohort study of adolescents with type 1 diabetes who~     participated in ETPACAP program, consisting of three components:~        -  A quantitative component: collection and analysis of changes over 6 months of~          self-efficacy, adherence, quality of life and HbA1c levels (ANOVA repeated measures);~        -  A qualitative component: interviews with 32 participants at M0, M3 and M6 on the~          socio-cognitive factors according to Bandura (analysis continues theming);~        -  An integrative component, exploring the effects of the components of social cognitive~          theory on adherence, glycemic control and quality of life of adolescents with type 1~          diabetes cohort.~      Expected results: This research is expected to bring new knowledge about the ETP programs and~     the adolescent cohort studied to make an improvement and adjustment of educational sessions~     relevant to the needs and expectations of this population.~   "
54025|NCT02859805|"~     The objective of this study is to validate a diagnostic tool severity of these common~     non-motor manifestations, disturbing and little recognized as a self-questionnaire. This~     assessment tool used on different subgroups of patients (free from any treatment at an early~     stage of the disease and the stage of motor complications) will better understand the natural~     history of the non-motor fluctuations (FNM)~   "
54026|NCT02859792|"~     The study will be conducted in two steps:~        1. Determination of the Minimal Effective Dose (MED) among the four doses of the panel~        2. Estimation of the probability of response associated to the MED.~      Each step has a main objective:~      Step 1 Objective: To determine a daily dose of Riluzole that improves spasticity in patients~     with chronic SCI~      Step 2 Objective: To demonstrate, in a phase 2b trial, the efficacy of Riluzole to improve~     spasticity vs placebo, in patients with chronic SCI.~   "
54027|NCT02859779|"~     Background: In type 1 diabetes, adolescence is often associated with deterioration in~     glycemic control, attributed to a poorly monitored diet, little exercise, poor treatment~     compliance, risk behaviors, endocrine changes with puberty, leading to greater resistance to~     insulin. Therapeutic patient education (TPE) is the key to successful management of the~     disease and treatment for adolescents with type 1 diabetes. Ten TPE programs exist in the~     Mediterranean region in France, and the care teams implementing them wish to promote joint~     reflection with sick teenagers and families to identify needs and expectations of everyone on~     priority skills to develop, to promote better management of the disease and improved quality~     of life.~      Aim: To study the needs and expectations of adolescents with type 1 diabetes for skills to be~     developed during the educational sessions, to promote self-management of their disease and~     their treatment.~      Method: Four audio-recorded focus groups will be organized in all 10 clinical settings~     (adolescents, parents and health professionals). Thematic analysis will be carried out from~     the transcript of the focus groups.~      Expected results: The results will allow a joint reflection involving the participation of~     young patients, families, health professionals and the research team to build and implement~     new educational sessions that meet the identified needs. This action resulting from the~     research is expected to pool resources in different health facilities providing therapeutic~     education programs and to harmonize practices.~   "
54028|NCT02859766|"~     This study will evaluate the safety and characterize the systemic pharmacokinetics (PK) of~     free and vascular endothelial growth factor (VEGF)-bound abicipar following single and~     multiple intravitreal injections of abicipar pegol in treatment-naïve patients with~     neovascular age-related macular degeneration (AMD).~   "
54029|NCT02859753|"~     To date, the majority of studies that have evaluated the efficacy of microwave ablation (MWA)~     in the treatment of hepatocellular carcinoma (HCC) lesions in cirrhotic patients and compared~     its efficacy with that of percutaneous radiofrequency ablation (RFA) for local recurrence and~     survival have been retrospective. There have been no prospective randomized studies comparing~     percutaneous microwave ablation (PMWA) with RFA for ablated tumour volume, the response after~     one session, local recurrence rates in the first year, complication rates and survival at 3~     and 5 years for HCC lesions > 2 cm in patients with Child-Pugh A and B cirrhosis. The~     hypothesis the investigators wish to explore is that though the 2 methods are equivalent for~     lesions ≤ 2 cm, MWA could show better efficacy with a similar risk for lesions > 2 cm and for~     lesions close to vessels ≥ 3 mm in diameter, as shown in retrospective studies.~   "
54030|NCT02859740|"~     The objective of this study is to demonstrate the validity, the reproducibility and the~     coherence of the French version of the Special Interest Group in Amputee medicine (SIGAM)~     mobility scale questionnaire in adults with lower-limb amputations.~   "
54031|NCT02859727|"~     This study is designed to provide long-term CDZ173 treatment, a selective PI3Kδ inhibitor, to~     the patients with genetically activated PI3Kδ, i.e., patients with APDS/PASLI that already~     participated to the CDZ173X2201 study. The study is open-label designed to establish the~     long-term safety, tolerability, efficay and pharmacokinetics of CDZ173 in the target~     population.~   "
54032|NCT02859714|"~     Previous studies have shown geographic disparities in the detection of colorectal adenomas in~     Côte-d'Or, with an impact of the distance from the general practitioner and an ecological~     deprivation index (EDI). On the other hand, the extremely low detection rates for these~     lesions in everyday practice before the implementation of organized screening for colorectal~     cancer in the Côte-d'Or were shown. One of the aims of this screening is to reduce~     socio-geographic inequalities in access to care and prevention. Yet, participation in~     screening also varies depending on the socio-economic level. In this context, the Côte-d'Or~     Polyps Registry, the only body to have data for the pre-screening period (before 2003), will~     make it possible to determine whether the implementation of organized screening led to the~     elimination of socio-geographic disparities concerning the detection of adenomas.~   "
54033|NCT02859701|"~     Single-centre, randomised, double blind, placebo controlled, single ascending dose study and~     multiple dose study. AK002 will be administered as an intra-venous (IV) infusion in eight~     cohorts of single escalating doses and two cohorts with multiple doses. The study will~     comprise of 3 parts: Part A (Cohorts 1 - single ascending dose); Part B (Cohorts 2 to 9 -~     single ascending dose); Part C (Cohorts 10 and 11 - multiple dose).~   "
54090|NCT02858960|"~     The aim of this study is to compare exercise capacity in COPD patients through two different~     systems of supplemental oxygen delivery: High Flow Nasal Cannula Oxygen (HFNCO) and The~     Venturi Mask (VM).~   "
54034|NCT02859688|"~     Like genetic mutations, DNA methylation anomalies or epimutations can disrupt gene expression~     and lead to human diseases.~      However, unlike genetic mutations, epimutations can in theory be reverted through~     developmental epigenetic re-programing, which should limit their transmission across~     generations. Following the request for a parental project of a patient diagnosed with~     Silver-Russell syndrome (SRS), and the availability of both somatic and spermatozoa DNA from~     the proband and his father, we had the exceptional opportunity to evaluate the question of~     inheritance of an epimutation. We provide here for the first time evidence for efficient~     reversion of a constitutive epimutation in the spermatozoa of an SRS patient, which has~     important implication for genetic counseling.~   "
54035|NCT02859675|"~     This study will improve our understanding of the mechanisms underlying anorexia in persons~     with Crohn's disease flare-ups. The practical spin-off from this research is potentially very~     important for the management of nutritional disorders associated with the disease by guiding~     diets towards foods that correspond to patients' preferences and/or to modified tastes. In~     addition, the results could lead to the identification of sensory markers that herald an~     inflammatory flare-up of the disease.~   "
54036|NCT02859662|"~     It is an observational study on ruptured abdominal aortic aneurysm and abdominal compartment~     syndrome.~      the aim of this study is to assess the qualities of a predictive score on the occurence of~     this syndrome after surgery of ruptured aortic aneurysm~   "
54037|NCT02859649|"~     According to the working memory model, which accounts for the organisation of working memory,~     the processing of non-meaningful gestures is not clear. Some authors suggest that working~     memory for non-meaningful gestures has the same characteristics as the phonological loop,~     made up of a phonological store and of a revival process (articulatory rehearsal). These~     characteristics are evidenced in memory span tasks, memory span which is itself determined by~     the duration of the memory trace and the time required to refresh the trace by subvocal~     rehearsal.~      The investigators therefore aim to set up a gestural working memory task, which is specific,~     simple and reproducible, in the manner of verbal and visuospatial span tasks. It will first~     be an exploratory and descriptive study with healthy subjects.~   "
54038|NCT02859636|"~     The main objective is to evaluate the pronostic value of endothelial dysfonction in acute~     heart failure on a combined criteria associating cardiovascular mortality, nex~     hospitalisation for decompensated heart failure, cardiac graft or ventricular assistance 2~     month and 1 year before acute heart failure.~   "
54039|NCT02859623|"~     Blastic plasmacytoid dendritic cell neoplasm (BPDCN) is a rare disease characterized by an~     aggressive clinical behavior and a poor prognosis. It predominantly affects elderly males~     with an average age of 67 years at diagnosis and the affected organs are usually the skin,~     bone marrow, lymph nodes and the central nervous system. Patients with BPDCN have poor~     outcomes with median overall survival (OS) ranging in the largest series of patients from 8~     to 12 months.~      Patient care must be defined in this pathology. Despite 40%-90% complete remission (CR) rates~     after initial chemotherapy, relapses are almost inevitable.~      The investigators have developed a national network to collect clinical and biological data~     of French patients diagnosed with BPDCN.~   "
54040|NCT02859610|"~     research on interactions between portal hypertension and microparticles~   "
54041|NCT02859597|"~     This study evaluates the ability of high flow nasal cannula versus nasal cannula to oxygenate~     morbidly obese patients undergoing moderate to deep sedation for gastrointestinal procedures.~   "
54042|NCT02859584|"~     A high frequency of adrenal dysfunction (AD) has been reported in severe acute hepatitis~     (SAH) using the dosage of serum total cortisol (STC). Because 90% of circulating serum~     cortisol is bound to proteins that are altered in SAH, we aimed to investigate the effect of~     decreased cortisol-binding proteins on STC, serum free cortisol (SFC) and salivary cortisol~     (SalivCort) in SAH.~      Baseline (T0) and cosyntropin-stimulated (T60) STC, SFC and SalivCort concentrations were~     measured~   "
54043|NCT02859571|"~     This study evaluates continuous oxytocin versus intermittent oxytocin for induction of labor~     at term. Half of participants will be taken continuous oxytocin, while the other half will be~     taken intermittent oxytocin.~   "
54044|NCT02859558|"~     The study is being done to:~        -  start ART early in those recently or acutely infected with HIV-1~        -  see how starting ART as soon as the infection is found affects the amount of HIV-1 in~          blood and how well the body fights the HIV-1 infection~        -  look at the amount of HIV-1 DNA (genetic material for HIV-1) seen in CD4+ T-cells~          (infection-fighting cells in blood) after 48 weeks of ART~        -  see how early treatment for HIV affects the numbers of HIV-1 infection fighting cells~          (CD4+ and CD8+ T-cells) in blood~   "
54045|NCT02859545|"~     Chronic pain is a highly prevalent and costly health care problem. Yet, little is known about~     the optimal ways for health care providers and family members to respond to the distress~     expressed by people with chronic pain. The aim of the current study is to compare two models~     of responsiveness to identify responses that result in better functioning and adjustment. An~     experimental design will be used to test the extent to which emotional validation (e.g., an~     empathic response to distress) increases or decreases pain behaviors during physical~     activity. Romantic partners of individuals with chronic pain will be randomly assigned to~     receive validation or control training. Following training, people with chronic pain and~     their partners will engage in a discussion about pain and complete household tasks to examine~     the effects of partner training on communication, pain intensity, and pain behavior.~     Additionally, each individual in the couple will complete self-report measures after the~     discussion, after the household tasks, and one-month following the laboratory visit.~   "
54046|NCT02859532|"~     Deep vein thrombosis (DVT) is a vascular disease characterized by the formation of a thrombus~     within the venous system, mainly the lower limbs. The clot structure directly influences both~     its location, but also its progressive profile expansion material or regression and embolic~     migration.~      Few data are available regarding the evolution of structural properties of thrombus after an~     acute episode of DVT. Thrombus formation is due to the polymerization of fibrinogen into~     fibrin. Fibrin is a viscoelastic polymer. Its mechanical properties directly determine how~     the thrombus responds to forces which it is subjected.~      Determining the mechanical properties of the thrombus in vivo and ex vivo is expected to~     study its evolutionary properties.~   "
54048|NCT02859506|"~     Today, we know that olfactogustatory alterations occur in cirrhotic patients before the liver~     transplant but no study has been conducted to show eventual disturbances after the~     transplantation able to explain modifications in eating behaviour. In parallel, the metabolic~     status, itself dependent on liver metabolism, influences food preferences and is modified~     after the transplantation as the liver recovers its ability to store glycogen, but is not~     able to inform the brain as the afferent nerve impulses have been suppressed. The innovative~     aspect of this project is to provide information on the importance of the liver in the~     regulation of energy homeostasis.~      The results of this study will improve our understanding of eating behaviour and~     olfactogustatory sensitivity and allow us to orient liver transplant patients towards~     appropriate diets.~   "
54049|NCT02859493|"~     This study aims to evaluate the effect of a specific strain of Saccharomyces cerevisiae on~     improving the effectiveness of conventional treatment of vulvo-vaginal candidiasis. This is a~     randomized, double-blind, placebo-controlled study. The administration of yeast will be local~     (vaginal).~   "
54050|NCT02859480|"~     This study is a prospective, randomized, open-label, single-center trial designed to compare~     the 30 month-safety and efficacy between low-dose (5mg/dL) and high-dose (20mg/dL)~     rosuvastatin treatment for patients with coronary artery disease after percutaneous coronary~     intervention with the newer drug-eluting stent.~   "
54051|NCT02859467|"~     Objective: Compare the benefits of Kinesio Taping and Inhibitory Treatment Techniques for~     Cervical, Thoracic and Lumbar Spine in Patients with Fibromyalgia Syndrome (FMS).~      Study Design: A single-blind randomized controlled trial was conducted on patients with FMS.~      Setting: Clinical setting. Methods: Sixty-four subjects with FMS were randomly assigned to an~     experimental group receiving kinesio taping and inhibitory treatment techniques, or to a~     control group for exercises and electrical stimulation therapy.~   "
54052|NCT02859454|"~     Background:~      Recurrent respiratory papillomatosis (RRP) is a rare disease caused by human papillomavirus.~     It can cause voice changes, airway compromise, pulmonary lesions, and cancers. PD-L1 is a~     protein on cells. It may be able to stop or decrease the immune system s response to viruses~     such as human papillomavirus. The drug Avelumab interferes with the activity of PD-L1.~     Researchers want to see if Avelumab treats RRP and study its side effects.~      Objective:~      To see if Avelumab works in treating RRP and is safe.~      Eligibility:~      People ages 18 and older with aggressive RRP that has not responded to available treatments~      Design:~      Participants will be screened with:~      Medical history~      Previously collected tumor tissue~      Physical exam~      Blood, urine, and heart tests~      Endoscopy procedure: A small tube with a camera is used to look in the nose, throat, larynx,~      and upper windpipe.~      Before starting treatment, participants will have:~      Endoscopy under anesthesia. A sample of papilloma will be taken.~      Voice handicap questionnaire~      CT scans~      Apheresis: An IV is inserted into an arm vein. White blood cells are separated~      from the rest of the blood and stored for research. The rest of the blood is returned~      through the same IV or one in the other arm.~      Participants will get the study drug by IV every 2 weeks for up to 12 weeks.~      Participants will repeat the previous tests throughout the study.~      If they respond to treatment, participants will be evaluated every 6 weeks (3 times), then~     every 12 weeks (3 times), then every 26 weeks (2 times) until their disease progresses.~      Participants will be evaluated 30 days after their last infusion. They will then be contacted~     annually.~   "
54053|NCT02859441|"~     Objective: Von Hippel-Lindau (VHL) disease is an autosomal dominant heritable disorder in~     which multiple benign and malignant neoplasms and cysts of specific histopathologies develop~     in the kidney, adrenal gland, pancreas, brain, spinal cord, eye, inner ear, epididymis and~     broad ligament. The disease affects about 7,000 individuals in the United States. Retinal~     capillary hemangiomas (RCH) are the most common and often the earliest manifestation of VHL~     disease and may lead to significant vision loss. In some such eyes, inexorable progression of~     RCH leads to blindness and phthisis bulbi despite aggressive treatment. Levels of vascular~     endothelial growth factor (VEGF), a potent mediator of angiogenesis and vascular~     permeability, have been shown to be elevated in multiple cell types deficient in the VHL~     protein (pVHL). Platelet-derived growth factor (PDGF), which has an important role in~     stabilization of immature new vessels during angiogenesis, is upregulated in pVHL-defective~     cell lines and expressed in other pVHL-defective tumors. Anti-VEGF therapy alone had no~     beneficial effect on ocular VHL disease in two previous phase 1 studies. The objective of~     this study is to investigate the safety and possible efficacy of combination investigational~     treatment with serial intravitreal injections of E10030, a PDGF-B antagonist, and~     ranibizumab, a VEGF-A antagonist, in participants with severe ocular VHL disease.~      Study Population: Three participants with severe ocular VHL disease will receive the~     combination investigational treatment in one eye and will be followed for 104 weeks.~      Design: In this phase I/II, single-center, prospective, open label, non-randomized,~     uncontrolled, single group trial, one eye of eligible participants will be treated with~     investigational products, E10030, a PDGF-B antagonist, and ranibizumab, a VEGF-A antagonist.~     Participants will receive combination investigational treatment consisting of intravitreal~     injections of E10030 (1.5 mg in 0.05 mL) and ranibizumab (0.5 mg in 0.05 mL) every four weeks~     from baseline through Week 16 (totaling five treatments) and then every eight weeks through~     Week 48 (totaling nine treatments from baseline). All participants will be followed for 104~     weeks.~      Outcome Measures: The primary outcome for the study will be safety of the combination~     investigational treatment, assessed by tabulation of adverse events reported through Week 52.~     Secondary outcomes will include tabulation of adverse events at Week 104, and the following~     measures in the study eye at Week 52 and 104: the proportion of participants experiencing~     reduction in size of at least one RCH in the absence of other ablative treatment (assessed by~     fundus photography and fluorescein angiography [FA]); the proportion of participants~     experiencing moderate vision loss (defined as a loss of greater than or equal to 15 letters~     from baseline on Electronic Visual Acuity [EVA] testing); mean change in visual acuity;~     change in size of RCH (measured by fundus photography and FA); change in exudation (measured~     by fundus photography, optical coherence tomography [OCT] and FA); change in epiretinal~     proliferation, fibrosis or retinal traction (assessed by OCT and fundus photography);~     proportion of participants undergoing ablative treatment of RCH or ocular surgery; proportion~     of participants with successful ablative treatment of RCH; and the proportion of participants~     with appearance of one or more new RCH.~   "
54054|NCT02859428|"~     Background:~      Hereditary spastic paraplegia (HSP) usually progresses slowly. Researchers want to learn more~     about how its symptoms change over time. They want to look for changes in the blood and cells~     of people with the most common forms of HSP that might allow them to better understand the~     disease.~      Objectives:~      To learn more about common forms of hereditary spastic paraplegia and find out how it~     progresses over time.~      Eligibility:~      People age 7 and older with SPG3A, SPG4A, or SPG31~      Design:~      Participants will have 1 two-hour visit each year for up to 5 years.~      At 1 visit, adult participants may have a skin biopsy. An area of skin will be numbed then a~     tool will remove a small piece of skin.~      At all visits, all participants will have a physical exam and blood drawn.~      At all visits, participants will do a few tasks like walking quickly and climbing stairs.~      Participants can give permission for their skin cells, DNA samples, and data to be used in~     other studies. The samples and data will have no identifying information.~   "
54055|NCT02859415|"~     Background:~      Mithramycin is a new cancer drug. In another study, people with chest cancer took the drug 6~     hours a day for 7 straight days. Many of them had liver damage as a side effect. It was~     discovered that only people with certain genes got this side effect. Researchers want to test~     mithramycin in people who do not have those certain genes.~      <TAB>~      Objectives:~      To find the highest safe dose of mithramycin that can be given to people with chest cancer~     who have certain genes over 24 hours instead of spread out over a longer period of time. To~     see if mithramycin given as a 24-hour infusion shrinks tumors.~      Eligibility:~      People ages 18 and older who have chest cancer that is not shrinking with known therapies,~     and whose genes will limit the chance of liver damage from mithramycin~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Blood and urine tests~      Lung and heart function tests~      X-rays or scans of their tumor~      Liver ultrasound~      Tumor biopsy~      Participants will be admitted to the hospital overnight. A small plastic tube (catheter) will~     be inserted in the arm or chest. They will get mithramycin through the catheter over about 24~     hours.~      If they do not have bad side effects or their cancer does not worsen, they can repeat the~     treatment every 14 days.~      Participants will have multiple visits for each treatment cycle. These include repeats of~     certain screening tests.~      After stopping treatment, participants will have weekly visits until they recover from any~     side effects.~   "
54056|NCT02859402|"~     Relapsed and refractory T-cell lymphomas have been reported to have dismal outcomes. The role~     of allogeneic stem cell transplantation have been demonstrated in these patients. This~     clinical trial is studying the efficacy and safety of busulfan plus fludarabine as~     conditioning therapy followed by allogeneic stem cell transplantation (Allo-SCT) in T- and~     NK/T-cell lymphoma patients who have relapsed or are refractory to previous chemotherapies~     including autologous transplantation.~   "
56594|NCT02826213|"~     Comparison of two techniques of renal pre-transplant infusion on the evolution of renal~     function in the recipient: multicentre randomized trial~   "
54057|NCT02859389|"~     Survivors of acute lymphoblastic leukemia (ALL) are at risk for neurocognitive deficits,~     reduced educational and psychosocial outcomes, and lower quality of life. Neurocognitive~     assessment is frequently implemented during therapy and continued into survivorship to~     monitor functioning and to facilitate intervention. Children with Down Syndrome (DS) are at~     10 to 20-fold increased risk for leukemia. Survival rates for leukemia patients with DS are~     comparable to or lower than patients without DS, however, these patients are at greater risk~     for treatment-related toxicities. Children with preexisting neurodevelopmental conditions,~     including DS, are systematically excluded from neurocognitive assessment on clinical trials,~     contributing to a gap in the investigators understanding of outcomes in these patients with~     preexisting neurocognitive vulnerability. The investigators propose a novel preliminary~     investigation of functional outcomes in children with DS and childhood leukemia. This study~     has implications for future treatment of leukemia patients with DS, and may generalize to~     leukemia patients with other predispositions or preexisting neurodevelopmental conditions~     (e.g., genetic disorders, acquired brain injury, autism, and epilepsy).~      Primary Objective:~        -  To describe neurocognitive and psychosocial outcomes in survivors of childhood leukemia~          with Down Syndrome using a novel assessment approach.~   "
54058|NCT02859376|"~     The objective of this trial is to compare the analgesic effect of a single dose of oral~     sucrose 24% administered two minutes before a blood sampling (either heel prick or vascular~     puncture) versus multiple doses of oral sucrose 24% administered two minutes before and~     during the procedure in a population of preterm newborns of Gestational Age ≤ 36+6 weeks~     hospitalized in Neonatal Intensive Care Unit, using neonatal pain scales (Premature Infant~     Pain Profile (PIPP), Face, Legs, Activity, Cry, Consolability (FLACC) and indirect Visual~     Analogue Scale (VAS)) and Skin Conductance (SC) measurement (Pain Monitor).~   "
54059|NCT02859363|"~     Fabry disease is an X-linked disorder of glycosphingolipid catabolism caused by a deficiency~     of the enzyme α-galactosidase A (α-Gal A), which leads to a progressive accumulation of~     globotriaosylceramide (Gb-3) in plasma and tissue lysosomes throughout the body. Lysosomal~     accumulation can result in lysosomal and cellular dysfunction, which leads to renal, cardiac,~     and central nervous system (CNS) complications.~      It is estimated that 1 in 40,000 males has Fabry disease, whereas the estimated prevalence in~     the general population is 1 in 117,000 people. Newborn screenings for both classical and~     atypical Fabry disease in Taiwan also revealed a markedly high incidence of 1 in 2,300 and 1~     in 3,000 newborns. Cerebrovascular variant Fabry disease may affect up to 4.9% of male~     patients and 2.4% of female patients with idiopathic stroke.~      The diagnosis of Fabry disease can be challenging due to the diverse signs and symptoms,~     different ages of onset, and variable timing and severity of progression. The importance of~     Fabry disease lies in the irreversible renal, cardiac, cerebrovascular, and neurological~     damage. An early diagnosis of Fabry disease is important for initiating symptom management~     and reducing life-threatening complications, as well as for early identification of other~     affected family members. Therefore, the present study would like to conduct further screening~     of high-risk group of early cerebrovascular involvement that is essential for the successful~     management of Fabry disease.~   "
54060|NCT02859350|"~     This trial will evaluate the safety, tolerability, and immunogenicity of PfSPZ Vaccine in~     healthy Equatoguinean adults, adolescents, children and infants who receive doses of~     0.9x10^6, 1.8x10^6 or 2.7x10^6 PfSPZ Vaccine via direct venous inoculation (DVI) compared~     with control groups receiving normal saline (NS) placebo by DVI. In addition, the study will~     also assess a second PfSPZ-based vaccination approach known as PfSPZ-CVac- the administration~     of non-irradiated, infectious PfSPZ (PfSPZ Challenge) (1x10^5 PfSPZ) under anti-malarial~     chemoprophylaxis (chloroquine) in younger adults ages 18 to 35 years for safety,~     tolerability, immunogenicity and efficacy against controlled human malaria infection (CHMI).~   "
54061|NCT02859337|"~     Obese women are significantly more likely than their normal BMI counterparts to experience~     failure of orally-dosed emergency contraceptives. Our preliminary data provides evidence for~     testing a dose escalation strategy in an effort to provide improved efficacy from~     orally-dosed emergency contraceptives in obese women. More data is needed regarding emergency~     contraception containing ulipristal acetate. The overall project will be focused on both~     levonorgestrel (LNG) - and ulipristal acetate (UPA)-containing emergency contraception but~     this protocol registration is for the UPA aspect of the study procedures.~   "
54062|NCT02859324|"~     CC-122-HCC-002 is a Phase 1/2 dose escalation and expansion clinical study of CC-122 in~     combination with nivolumab in subjects with unresectable hepatocellular carcinoma (HCC) who~     have progressed after or were intolerant to no more than 2 previous systemic therapies for~     unresectable HCC, or are naïve to systemic therapy.~   "
54063|NCT02859311|"~     One third of patients diagnosed with heart failure demonstrate left ventricular reverse~     remodelling and recovery of cardiac function following a period of medical therapy. These~     patients have an excellent long-term prognosis. Whether they need to remain on long-term~     medical therapy is not clear. The investigators will investigate the safety of therapy~     withdrawal in patients with a previous diagnosis of heart failure and recovered cardiac~     function, in a randomised controlled trial.~   "
54064|NCT02859298|"~     Prematurity is the first cause of perinatal mortality and morbidity worldwide. The threat of~     premature delivery (TPD), the most important complication and the leading cause of~     hospitalization during pregnancy has multiple origins which are seldom precisely identified.~      The standard medical examination for the detection of patients with TPD is the endovaginal~     ultrasonographic examination of uterine cervix (echography).~      Gynaecologists focus on the use of a new low-cost diagnostic tool based on optical imaging~     technologies with polarized light. The polarization is the spatio-temporal orientation of a~     wave's electric field. This light property, invisible with the naked eye, is sensitive to the~     morphological transformations of a tissue and the orientation of collagen fibers. Such tool~     would not require an extensive training and should provide an objective quantitative result~     with a sensitivity and specificity greater than conventional ultrasonography. This would be a~     considerable contribution to the health care of TPD, a real societal problem in Belgium,~     Europe and all over the world.~      The POLARMAP project proposes the possibility to observe in vivo and during pregnancy, the~     structural evolution, the density and the orientation changes of collagen fibers. A relevant~     scoring of collagen status might provide an alternative, and potentially objective and~     accurate quantifier of the time left before delivery.~   "
54066|NCT02859272|"~     Female pelvic organ prolapse (POP) is characterized by lack of vaginal support which enables~     pelvic organs to bulge into the vaginal walls and sometimes protrude through the genital~     hiatus. POP is more frequent among women who had their uterus removed.~      We would like to investigate whether suspension of the top of the vagina during remowal of~     the uterus prevents subsequent POP.~      The purpose of the PhD project is therefore to describe validity, terminology, and operative~     performance of used suspension methods during benign hysterectomy in Denmark. Further, to~     investigate these suspension methods' possible association with pain, life quality,~     sexuality, pessary use, and POP .~   "
54067|NCT02859259|"~     An oral dose in healthy subjects to determine the relative bioavailabilty of BMS-626529~     administered as BMS-663068~   "
54068|NCT02859246|"~     It is a pilot study aimed to determine if oral Mucinex® is effective in reducing the amount~     of corneal filaments and improving symptomology in subjects with filamentary keratitis.~   "
54069|NCT02859233|"~     Postdural puncture headache (PDPH) is defined, according to the International Headache~     Society, as any headache develops within 5 days after a lumbar puncture. It worsens within 15~     minutes after sitting or standing and improves within 15 minutes after lying.~      For preventing PDPH, there are some uncomfortable practices for patients (fluid~     supplementation and bed rest) and expensive for hospital (time spend for information and~     management of fluid intake). Patients are usually advised by nurses. If bed rest is not~     effective in prevention of PDPH, fluid supplementation is not an advice based on any~     evidence but only on routine. By this trial, the investigators want to evaluate the~     scientific value of this advice, in the standard patient care.~      The primary objective of this study is to compare oral hyperhydration (2 liters during 2~     hours after lumbar puncture - the most common routine according to an internal pilot survey)~     versus no advice about the fluid intake to prevent the PDPH.~      The second objective is to observe the day of apparition of PDPH, between day 0 and day 5.~   "
54070|NCT02859220|"~     This study included 80 patients with end stage renal disease requiring dialysis treatment to~     evaluate two techniques for the determination of parathyroid hormone (PTH)~      Objective: To evaluate whether the monitoring of hemodialysis patients by measurement of PTH~     1-84 Complete (CAP =cyclase activating PTH) and the ratio (1-84 PTH (CAP)/7-84 PTH (CIP =~     cyclase inactivating PTH) with kit Duo PTH Immunoradiometric Scantibodies allows an~     improvement in the therapeutic management of abnormal calcium and phosphate, with a better~     match to the targets of current international recommendations, followed by the conventional~     intact PTH assay.~      Primary endpoint:~      For each patient, a score will be awarded based on the number of criteria (including calcium,~     phosphorus and calcium phosphate product) in the target international guidelines :0-1-2 or 3.~      The primary endpoint will be the average scores in both groups at the beginning and the end~     of the study,~      Main secondary endpoints:~        -  Changes in the number of patients responding to international guidelines for each of the~          three parameters studied (serum phosphate, corrected calcium, phosphorus product) in the~          2 groups,~        -  Evolution of Elecsys intact PTH Roche in the 2 groups,~        -  Salaries and changes in the number of drugs to normalize the phospho-calcium balance in~          each group received,~        -  cardiovascular events (morbidity and cardiovascular mortality),~        -  Total mortality.~      Statistical analysis:~      This is a randomized, two parallel arms. The investigators will compare the average number of~     criteria on calcium and phosphate in the target according to a Mann-Whitney. The analysis~     will be performed with the software Splus.~   "
54071|NCT02859207|"~     The primary objective of the study is to evaluate the effects of hepatic impairment on the~     pharmacokinetics (PK) of E2609 after a single dose administration.~   "
54072|NCT02859194|"~     ECMO(Extracorporeal membrane oxygenation) is being essential for cardiopulmonary failure~     patients. There are two types of ECMO, which is veno-veno (V-V) that can be used in~     respiratory failure patients and veno-arterial (V-A) that can be used in cardiac failure~     patients. V-A ECMO can also be used during lung transplantation, substitution of~     cardiopulmonary bypass, which can show sufficient performance during operation and better~     postoperative outcome. However, regarding V-A ECMO circulating from femoral vein to femoral~     artery, there is a pro blem of differential hypoxia which might influence coronary artery and~     head vessels. In this prospective study, the investigators are planning to put another ECMO~     catheter into internal jugular vein which takes a role of left to right shunt, to mitigate~     the hypoxia of coronary artery.~   "
54073|NCT02859181|"~     Protein requirements in active individuals have been suggested to be greater than the current~     recommended dietary allowance (RDA).~      Nutritional requirements for dietary amino acids in adolescents have traditionally been~     determined utilizing the nitrogen balance technique, which is prone to underestimating~     protein requirements. As a result, there is a need to re-evaluate recommendations in order to~     characterize how dietary amino acid needs may be modulated by physical activity.~      Recent studies using the minimally invasive indicator amino acid oxidation (IAAO) technique~     have suggested that protein requirements in young men are at least 50% higher than the RDA~     based on nitrogen balance data.~      The purpose of this study is to measure the protein requirement in adolescent, males using~     the IAAO technique in the presence of a variable intensity exercise stimulus.~   "
54074|NCT02859168|"~     The purpose of this study was to show the immediate effects of myofascial induction on~     perceived pain and anxiety, cervical/shoulder range of motion and mood state in breast cancer~     survivors suffering shoulder/arm morbidity.~   "
54075|NCT02859155|"~     Determine clinical and pathological factors associated with perioperative morbidity and~     mortality, and oncological outcomes after multivisceral en bloc resection in patients with~     colorectal cancer.~   "
54076|NCT02859142|"~     The purpose of this study is to learn if the combination of a study drug and patch is more~     effective in helping heavy drinkers stop smoking than just the patch alone The study drug,~     varenicline, has been approved by the Food and Drug Administration (FDA) to help people stop~     smoking, but it is not known if the addition of varenicline to standard smoking cessation~     treatment with nicotine patches will help people stop smoking who are regular, frequent~     drinkers. This study is being done because cigarette smoking is the number one preventable~     cause of death and disease in the United States.~   "
54077|NCT02859129|"~     This study is intended to evaluate the potential 2-way reciprocal interaction between~     multiple doses of Epanova™ and a single dose of rosuvastatin~   "
54079|NCT02859103|"~     Anhedonia (the lack of pleasure in normally pleasurable things) is a common symptom of major~     depressive disorder (MDD), and it may impact how patients with depression experience reward.~     Understanding how anhedonia is related to the experience of reward may help improve how~     depression is treated. Computer tasks can be used to measure how reward is experienced, and~     these measures might be able to predict things like who is likely to become depressed, or who~     will respond to antidepressant medication. Studying the relationship between anhedonia and~     reward in patients with depression might also tell us something about how to improve~     diagnosis and treatment of other psychiatric disorders.This is an open label controlled~     treatment study lasting 8 weeks. The brain scans will be used to find changes in brain areas~     that may be related to how people perform on the tasks. The investigators goal is to use this~     information to help us find a reliable predictor that can be used to guide MDD treatment.~   "
54080|NCT02859090|"~     It has recently been shown that various HSPs are strongly expressed in B lymphomas. Indeed,~     HSP90 stabilizes the protein Bcl-6 in diffuse large-cell B lymphomas. Pharmacological~     inhibition of HSP90 in vitro induced apoptosis in lymphoma cells (Cerchietti et al. Nat.~     Medicine, 2009, 1369-1376). In addition, HSP110 is strongly expressed in non-Hodgkin~     lymphomas, and targeting this HSP at the cell surface using specific antibodies could~     constitute a future therapy (Zappasodi et al. Blood, 2011, 4421-4430). Despite the importance~     of these proteins in the development of lymphomas, their expression and their role in the~     activation of normal B lymphocytes and the normal development of germinal centres is not~     known.~      The expression of Heat shock proteins should vary among the different B lymphocyte~     populations present in the tonsils (naïve B cells, memory B cells, germinal centre B cells).~      The aim of this study is to establish an expression profile for heat shock proteins in~     populations of B lymphocytes in human tonsils~   "
54081|NCT02859077|"~     BIM deletion polymorphism might be associated with a poor clinical response to EGFR-TKIs in~     patients who had NSCLC with EGFR mutations. In the study, the investigators want to use~     EGFR-TKI with chemotherapy as first line treatment in stage IIIB/IV NSCLC patients with both~     EGFR mutation and BIM deletion polymorphism.~   "
54082|NCT02859064|"~     Neuroendocrine tumors (NETs) and cancers that originate from the gastrointestinal tract can~     be resistant to standard chemotherapy and often metastasize to the liver. Lanreotide~     (Somatuline® Depot) Injection and Yttrium-90 microspheres (SIR-Spheres®) each have FDA~     approval to treat patients with metastatic NETs. The purpose of this study is to determine if~     treatment for patients with NETs can be optimized by combining these therapies.~   "
54083|NCT02859051|"~     The purpose of this study is to determine if a preparation teaching intervention before IV~     insertion, taught by MEDi to children and their parents, will lead to lower levels of~     expected and experienced pain and fear and less distressing pain memories, as compared to~     children who receive standard care. In addition, it will be examined whether this preparation~     intervention will lead to greater parental self-efficacy, less anxiety, and less distressing~     pain memories as compared to controls.~   "
54084|NCT02859038|"~     The purpose of this study is to answer the fundamental question, should the physicians choose~     Surgery or Chemotherapy (SOC 2) in advanced ovarian cancer?~   "
54085|NCT02859025|"~     Our aim was to combine regenerative techniques with bone grafting in human models to increase~     predictability and survival of reconstructed tissue. The MSCs in this study were derived from~     an intra oral fat source (BFP) and were cultured over natural bovine bone mineral granules~     and delivered within the lateral ramus cortical bone plate (LRCP)to treat human alveolar~     cleft defects.~   "
54086|NCT02859012|"~     To understand efficacy of axitinib in recurred or metastatic adenoid cystic carcinoma~   "
54087|NCT02858999|"~     Plasma cell leukaemia is a rare variety of multiple myeloma with a poor prognosis. Plasma~     cell leukaemia is defined as: at least 2,000 circulating plasma cells per µL for a blood~     leukocyte count higher than 10,000/µL or 20% of plasma cells for a leukocyte count less than~     10,000/µL. Plasma cell leukaemia can be either primary, when it constitutes the first~     manifestation of the disease, or secondary in the setting of relapsed/refractory multiple~     myeloma. Primary plasma cell leukaemia (PPL) is a rare disease, representing only 1 to 2% of~     all cases of multiple myelomas at diagnosis. As the annual incidence of multiple myeloma in~     France is about 4,000 new cases, an estimated 40 to 80 new cases of PPL would be observed~     each year.~      Few data are currently available in the literature concerning the pathophysiology and~     therapeutic management of PPL, and are derived from retrospective series based small numbers~     of patients. The prognosis of PPL in response to conventional chemotherapy remains poor with~     a median survival of 7 to 14 months. However, longer survivals have been obtained with~     intensive therapy and haematopoietic stem cell transplantation (allogeneic or autologous~     HSCT).~      The investigators propose to perform a prospective study of the management of patients with~     PPL under the age of 70 years, in combination with a laboratory study: 12 weeks of induction~     chemotherapy by liposomal Bortezomib-Dexamethasone-Doxorubicin (PAD) alternating with~     Bortezomib-Dexamethasone-Cyclophosphamide (VCD) for a total of 4 cycles. Peripheral blood~     stem cell collection after mobilization by G-CSF will be performed after high-dose~     Cyclophosphamide chemotherapy. Autologous HSCT conditioned by high-dose Melphalan will be~     performed during the following month for all responding patients. During the 3 months after~     this first autologous HSCT, allogeneic HSCT with attenuated conditioning will be proposed in~     patients under the age of 66 years in complete remission with a suitable donor, and another~     systematic autologous HSCT will be proposed in all other patients. For all patients not~     treated by allogeneic HSCT, consolidation/maintenance therapy will be performed 3 months~     after the second autologous HSCT: 4 quarterly consolidations with~     Bortezomib-Lenalidomide-Dexamethasone (VRD) with maintenance by 2 months of Lenalidomide~     between these cycles, for a total duration of one year.~      The laboratory assessment will consist of blood and bone marrow samples systematically~     obtained at diagnosis for plasma cell phenotyping by cytometry, cytogenetics, FISH, study of~     the gene expression profile and SNParray. A DNA bank and plasma bank will be constituted. The~     investigators also propose to study residual disease by cytometry (after the first autologous~     HSCT, before and at the end of the consolidation/maintenance phase), as it increasingly~     appears to have a major impact on survival in multiple myeloma.~   "
54088|NCT02858986|"~     Introduction: Three-dimensional key-hole surgery ('laparoscopic') systems are proven to~     reduce the time required to complete tasks in laboratory settings. This benefit derives from~     the addition of binocular depth perception cues when compared to two-dimensional (2D)~     systems. This year a '4K' laparoscopic system has become commercially available, so-named as~     it provides a high resolution 2D image with four times the number of pixels of 2D full high~     definition. The improved visualisation is likely to provide additional non-binocular depth~     cues. It is currently unclear to what degree improving the resolution of 2D systems can~     compensate for binocular depth cues.~      Aim: To determine whether the binocular vision provided by 3D laparoscopic systems provides~     benefits in simulated tasks when compared to the monocular vision provided by high-resolution~     4K systems.~      Methods: Two experiments will be performed: 1) A laboratory assessment of 3D versus 4K~     laparoscopic systems against industry optical standards, 2) A study to assess the benefits to~     novices and expert surgeons of using 3D and 4K laparoscopic systems during laparoscopic~     simulator tasks. The primary outcome measure is number of errors during laparoscopic~     simulator tasks. The secondary outcome measures include: objective and subjective measures of~     picture quality, task completion time, side effects (such as eye discomfort) and cognitive~     workload during laparoscopic simulator tasks~      Impact: This study is a unique, first-of-its-kind investigation into two new surgical~     technologies, and is the first study to involve a 4K system. The uptake of three-dimensional~     systems has been curbed by financial cost and the limitations of early 3D technologies. This~     study aims to determine which system may be the safest, quickest and most cost- effective, in~     order to guide future investment and technological development towards either 3D or 2D~     systems. In addition, these systems may also aid in the learning curve of trainee surgeons.~   "
54091|NCT02858947|"~     The aim of this study was to investigate the clinical effectiveness of direct resin composite~     restorations placed with different placement techniques (incremental or bulk) and with~     different flowable linings (conventional or bulk-fill flowable) used in open-sandwich~     technique, in endodontically treated Class II cavities (mesio-occlusal or disto-occlusal), in~     a randomized controlled comparison.~   "
54092|NCT02858934|"~     The standard treatment for women with a relatively small breast cancer without arguments for~     involvement of the axillary lymph nodes, is breast conserving surgery followed by~     radiotherapy of the whole breast, often with a complementary dose to the operated area~     (boost). A delay of 3-4 weeks after surgery is advisable for allowing wound healing before~     the start of radiotherapy. Historically, whole breast radiotherapy plus boost are delivered~     in 6-7 weeks. This treatment can be associated with temporary fatigue and decrease in quality~     of life. Randomized trials have shown that shorter schedules, delivering slightly more dose~     per day during 3 weeks, are equal to the long schedules. In an earlier clinical study, the~     investigators have tested such a short schedule and shown that it is equally safe and equally~     well tolerated as the conventional schemes. Other hospitals have examined (and still are~     examining) the safety and tolerance of even shorter schedules, delivering radiotherapy in 1~     week.~      This clinical study involves delivering radiotherapy in 1 week and before the surgery in~     stead of following surgery. In the postoperative setting, it is often debatable which volume~     should be included in the boost. Often boost-volumes remain large because of uncertainties in~     delineation. Preoperative radiotherapy has the advantage that the tumor is visible on~     imaging. This can result in smaller boost volumes. The surgery will follow shortly after~     termination of the radiotherapy, resulting in a very short treatment period.~      This study is an open study investigating the effect on quality of life of a very short~     preoperative radiotherapy for early breast cancer.~   "
54093|NCT02858921|"~     This study aims to determine which of 3 drug combinations best reduces the size of tumour~     prior to surgery for advanced melanoma and prevents the recurrence of melanoma after surgery.~   "
54094|NCT02858908|"~     The purpose of this study is to determine whether Tideglusib is safe and efficacious in the~     treatment of adolescents and adults with congenital and juvenile-onset Myotonic Dystrophy.~     The pharmacokinetics of tideglusib and its primary metabolite will also be investigated.~   "
54095|NCT02858895|"~     This is a single-arm, open-label, multicenter study in approximately 52 adults with primary~     (de novo) GB that has recurred or progressed (first or second recurrence, including this~     recurrence) after treatment(s) including surgery and radiotherapy with or without~     chemotherapy and following discontinuation of any previous standard or investigational lines~     of therapy.~   "
54096|NCT02858882|"~     People living at Northern latitudes are at risk of suffering from vitamin D insufficiency due~     to low sun exposure and the risk may be even more pronounced among elite swimmers since~     indoor training further reduces sun exposure. In light of this, the investigators want to~     examine vitamin D status in young elite swimmers and if there is an association between~     vitamin D status and muscle strength.~   "
54097|NCT02858869|"~     This pilot trial studies the side effects of giving pembrolizumab together with stereotactic~     radiosurgery to treat patients with melanoma or non-small cell lung cancer that has spread to~     the brain. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of~     tumor cells to grow and spread. Stereotactic radiosurgery is a specialized radiation therapy~     that delivers a single, high dose of radiation directly to the tumor and may cause less~     damage to normal tissue. Giving pembrolizumab together with stereotactic radiosurgery may be~     a better treatment for patients with melanoma or non-small cell lung cancer that has spread~     to the brain.~   "
54098|NCT02858856|"~     This is a pilot study that investigate efficacy and safety of Sipjeondaebo-tang on fatigue of~     patients with breast carcinoma receiving chemotherapy.~   "
54099|NCT02858843|"~     The purpose of this research study is to find out if the combined therapy~     lumacaftor-ivacaftor affects glycemia in patient with cystic fibrosis.~   "
54100|NCT02858830|"~     Studying patients with rare adipose tissue disorders may help the investigators to better~     understand the pathophysiology of diabetes and dyslipidemia in relation to adiposity, and~     thus have an enormous impact on public health.~   "
54101|NCT02858817|"~     Single center, randomized, placebo-controlled, double-blinded trial using PfSPZ Challenge~     (NF54) under A/P chemoprophylaxis for immunization and PfSPZ Challenge (NF54) for repeat~     CHMI.~      A total of 30 adult, healthy, malaria naïve volunteers will receive three injections by~     Direct Venous Inoculation (DVI) of either placebo (n = 10), 51,200 PfSPZ Challenge (NF54) (n~     = 10), or 150,000 PfSPZ Challenge (NF54) (n = 10) under chemoprophylaxis with A/P at 4 week~     intervals. The placebo will be NaCl 0.9%.~      Ten weeks after the last dose of PfSPZ Challenge (NF54) for immunization, volunteers will~     undergo first CHMI and followed until asexual blood stage parasitemia, detected by~     quantitative real time PCR (qPCR) or thick blood smear microscopy. If parasitemic, they will~     be treated with A/P (used in this case as a standard treatment regimen). In the event of no~     parasitemia, volunteers will be followed until Day 28 post-CHMI and will not receive A/P.~      Forty-four weeks after the last immunization, a second CHMI will be administered to assess~     longevity of protection. All volunteers will be followed up to 28 days post-inoculation.~     Those developing parasitemia will be treated with A/P.~   "
54102|NCT02858804|"~     The purpose of this study is to:~        1. determine the efficiency of EDOCH (etoposide,dexamethasone,doxorubicin, cyclophosphamide~          and vincristine) alternating with DHAP (cisplatin, cytarabine and dexamethasone) regimen~          combined with rituximab or not in young mantle cell lymphoma patients (age≤65 years);~        2. determine the efficiency of rituximab and thalidomide plus prednisone as maintenance~          regimens.~   "
54103|NCT02858791|"~     The investigators will investigate the interrelationship of macrophage migration inhibitory~     factor (MIF) and free T4 in patients with PAH.~   "
54104|NCT02858778|"~     A prospective randomized controlled trial studying the ordering of palliative care~     consultations in the emergency department (Ig) versus later palliative care consultations in~     the hospital--ICU or hospital ward(Cg). Patients will be randomly allocated to Ig or Cg with~     a 1:1 ratio.~   "
54105|NCT02858765|"~     The purpose of this project is to study the influence of light on sleep, wakefulness, EEG~     activity and cognitive performances. The study aim also to evaluate techniques for~     registration and analysis of the EEG over periods of time.~   "
54106|NCT02858752|"~     This project studies memory and attention in healthy children aged from 5 to 17 years. The~     processes investigated are short term memory (auditory and visual) and attention.~      To characterize these processes involved in childhood, neuropsychological and~     neurophysiological assessments will be performed (using Electro-encephalography measures,~     behavioural responses and questionnaires).~   "
54107|NCT02858739|"~     AIM OF THE STUDY: The aim of the present registry is to investigate the procedural as well as~     the long-term clinical results in terms of safety and efficacy of the polymer-free DES~     technology in all comers patients with an indication to percutaneous coronary intervention.~      PRIMARY SAFETY ENDPOINTS: the cumulative hierarchical incidence of major adverse cardiac~     events (MACCE) defined as: cardiac death, non-fatal myocardial infarction (MI), stroke and~     ARC-defined stent thrombosis (18) at any time point and bleeding defined according to BARC~     classification (19).~      PRIMARY EFFICACY ENDPOINTS: clinically driven target lesion revascularization (TLR).~      STUDY DESIGN: multicenter (presumably 10 centers across the Italian territory), prospective~     observational registry aiming to enroll a population of 1000 patients.~      STUDY DURATION: We project 12 months for recruitment, 5 year follow-up duration after last~     patient in the registry.~      CLINICAL FOLLOW-UP PLAN: 30 days, 3, 6, 9 months, 1 year, and then yearly up to 5 years after~     the index procedure.~      PATIENTS SELECTION CRITERIA:~      This is an all comers registry and patient who will be enrolled have to meet the sequent~     criteria:~        -  Patient must be at least 18 years of age at the time of signing the Informed Consent~          Form after Biofreedom placement.~        -  All de novo lesion subsets are included.~        -  Patient must agree to undergo all required follow-up visits and data collection.~        -  Patient must have indication to percutaneous coronary intervention following:~             -  Stable angina or evidence of myocardial ischemia with stress echocardiography/~               myocardial SPECT/exercise test, or~             -  Unstable angina / non ST-elevation myocardial infarction~             -  ST-elevation myocardial infarction with de novo culprit lesion.~      EXCLUSION CRITERIA:~      The exclusion criteria must follow the most recent IFU which may include but are not limited~     to the following:~        -  Known intolerance to any of the device components~        -  In-stent restenosis~        -  Woman with childbearing potential~        -  Age < 18y/o~        -  Inability to provide written informed consent~      EFFICACY PARAMETERS: TLR and TVR up to 5-year follow-up.~      SAFETY PATIENT ORIENTED PARAMETERS: all cause mortality, any myocardial infarction, Stent~     thrombosis based on the ARC classification, up to 5-year follow-up and bleeding occurrence~     according to BARC classification. Data on dual antiplatelet therapy use will also be~     collected and analyzed according to duration and cessation modalities.~      Sample size justification: Being this an observational registry aiming at quantifying effect~     estimates without direct comparisons to other devices for coronary angioplasty, we relied on~     confidence interval profiling for sample size justification, without proceeding with formal~     power analysis. The main analysis will be an overall and comprehensive analysis and it will~     be planned the primary analytical approach of all-comers patients with coronary artery~     disease and indication to PCI. Accordingly, we computed that a target sample of 1000 patients~     will enable the computation of reasonably precise 95% confidence intervals. Specifically,~     assuming a 8% MACE rate at 1 year (in keeping with RUDY study and LEADERS FREE trial design),~     confidence intervals computed with the adjusted Wald method would be 7.1% to 9.6% for a~     1000-patient sample (point estimate 80/1000 [8.0%]). Given that the registry aims to reflect~     real-world patients and practice, no prevision to limit or restrict patient enrollment is~     considered.~      Analytical plan: Continuous endpoints will be summarized by presenting the total number of~     patients, mean, standard deviation, median, minimum, and maximum. Tabulation of categorical~     parameters will include counts and percentages. The outcomes will be summarized as both a~     discrete and a continuous variable using the method described above. Survival analysis will~     be performed with the Kaplan-Meier method. Statistical inference will be based on the~     computation of 95% confidence intervals using the adjusted Wald method. Additional analyses~     will involve key subgroups defined according to baseline, lesion, and procedural features,~     with statistical significance set at the 5% 2-tailed level. Specifically, Student t, Fisher~     exact, and log-rank tests will be used for such bivariate analyses, whereas multivariable~     linear regression, logistic regression, and Cox proportional hazard analyses will be used to~     adjust for confounders.~   "
54108|NCT02858726|"~     2 Part Study: Part A will assess 3 different dosing levels of IV CR845 versus placebo in~     patient on hemodialysis who have moderate-to-severe itching due to uremic pruritus. Patients~     will receive either CR845 or placebo after each dialysis session for eight weeks. The safety~     and efficacy of CR845 will be monitored throughout the study. A sub-group of patients will~     also have pharmacokinetic assessments completed. Part B of the study will assess one dose of~     IVCR845 versus placebo for 12 weeks in patients on hemodialysis who have moderate-to-severe~     itching. The dose of CR845 used in Part B will be based on safety and efficacy found in Part~     A.~   "
54109|NCT02858713|"~     Medical adherence to topical corticosteroid products in psoriasis patients is a main~     determinant for poor treatment effect.~      The investigators aim to test if a multifaceted intervention delivered in an app (MyPso~     QualityCareTM owned by Leo Pharma) for smartphones combined with an Electronic Monitor (EM)~     (Teslo) can improve medical adherence among psoriasis patients treated with a topical~     calcipotriol/betamethasone dipropionate foam combination (Cal/BD) (Enstilar©).~      The study is classified as a phase 4 study, since it is studied if improved use of Enstilar©~     results in improved treatment outcomes.~   "
54110|NCT02858700|"~     After birth, in the presence of risk factors for early neonatal bacterial infection (IBNP),~     the pediatrician must make a difficult decision quickly or not to prescribe additional~     examinations and / or hospitalize or not the newborn in order to administer parenteral~     antibiotics. This decision takes into account several contextual data, (clinical, biological~     and bacteriological clinical data) to be considered simultaneously. These information lack~     sensitivity and specificity.~      Therefore, the common attitude among newborns in many countries remains the achievement of a~     significant number of additional tests and the establishment, without a prior evidence of~     infection, intravenous empirical antibiotic therapy for 48 -72h at least in hospitalization.~     However, the diagnosis of IBNP posteriori, is often reversed. This attitude is:~        1. one source to higher health care costs (hospitalization, additional examinations)~        2. Selection of the bacterial ecology of the newborn and neonatal services and~        3. stress for the newborn and parents~   "
54111|NCT02858687|"~     A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the~     diagnosis in less than two hours of tonsillitis caused by known pathogens, close to the~     reception of Emergency service. In this instance 30% of patients have no etiological~     diagnosis after the POC tonsillitis tests . This lab has discovered over 200 new species of~     bacteria in humans, including vector bacteria and opened the field of large Deoxyribonucleic~     Acid (DNA ) viruses. Also, the laboratory of emerging viruses discovered many Ribonucleic~     Acid (RNA) viruses transmitted by arthropods. Based on this collection of new pathogens~     described in POC laboratory, this study proposes to expand the etiological diagnosis strategy~     of tonsillitis after POC tests.~      The objective of this study is to implement a new diagnosis strategy relying on the~     hypothesis that a second pharyngeal swab would improve the etiological diagnosis of~     tonsillitis of at least 5%.~   "
54112|NCT02858674|"~     The objective of this proposal is to develop, implement, and test the effectiveness of a~     computerized clinical decision support system for hospitalized patients with heart failure.~      Aim 1: Develop an electronic health record (EHR) based search method that uses both~     structured data and natural language processing of unstructured text to identify hospitalized~     patients with heart failure while they are still in the hospital.~      Aim 2: Develop and test the usability of an electronic health record (EHR) based clinical~     decision support system (CDSS) to support delivery of evidence-based care to hospitalized~     heart failure patients using human computer interaction methods.~      Aim 3: Assess the effect of an electronic health record (EHR) based clinical decision support~     system (CDSS) on processes of care for heart failure patients who are hospitalized for other~     causes. As part of the evaluation, we will test two implementation strategies, one of which~     will introduce the CDSS as an interruptive alert to providers, the second of which will~     introduce the CDSS as part of a provider checklist that exists on the side of the screen for~     each patient.~   "
54113|NCT02858661|"~     A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the~     diagnosis in less than two hours of meningitis caused by known pathogens, close to the~     reception of Emergency service. In this instance 30% of patients have no etiological~     diagnosis after the POC diarrhoea tests . This lab has discovered over 200 new species of~     bacteria in humans, including vector bacteria and opened the field of large Deoxyribonucleic~     Acid (DNA ) viruses. Also, the laboratory of emerging viruses discovered many Ribonucleic~     Acid (RNA) viruses transmitted by arthropods. Based on this collection of new pathogens~     described in POC laboratory, this study proposes to expand the etiological diagnosis strategy~     of meningitis after POC test.~   "
54114|NCT02858648|"~     The purpose of this study is to examine whether a behavioral lifestyle intervention using~     mobile smart phone technology for self-monitoring can lead to greater improvements in~     diabetes outcomes.~   "
54124|NCT02858518|"~     Atrial fibrillation (AF) is a rhythmic cardiac activity disorder disturbing hemodynamic blood~     flow. It is a public health problem with 600,000 to 1 million people involved in France which~     2/3 are aged over 75 years. a FA untreated exposes the patient to a significant risk of~     embolism responsible for a rate stroke (stroke) ischemic estimated at 85%. The anticoagulant~     standard treatment helps prevent the occurrence of this complication.~      However, oral anticoagulation also exposes patients to an increased risk of bleeding. The~     bleeding risk can be assessed using scales: several being proposed (HEMORR2HAGES, HAS-BLED,~     ATRIA and scores Shireman and Charlson ...).~      moreover, in geriatric hospital care, every patient has a standardized geriatric assessment~     to assess and quantify functional capacity, autonomy, cognitive abilities, nutritional~     status, psychological state and its environment social.~      Thus, the objective of the investigators study was to determine the frequency of each item of~     each bleeding risk assessment score and geriatric assessment in patients 80 and older~     hospitalized geriatric ward in the department and with anticoagulant.~   "
54115|NCT02858635|"~     Suicide is a major health problem that causes annually a million death worldwide. In the~     stress-vulnerability model, suicidal behavior (SB) results from the interaction between an~     individual's predisposition and stressful condition. According to this model, individuals who~     carry a suicidal act when subjected to stress factors (environmental stress, depression,~     substance ...) are those which have a specific vulnerability.These vulnerabilities can be~     considered as clinical parameters (propensity to despair, aggressive and/or impulsive~     traits), neurobiological parameters (dysfunction of the serotonergic system, ...) and~     cognitive parameters (taking disadvantageous decision ...). Suicidal vulnerability is partly~     underpinned by genetic factors. The interest of current researches is to identify biomarkers~     that will improve the opportunities for early identification of subject with a risk for SB.~      The four goals of this project are in the continuity of previous works team:~        1. To determine whether combinations of the main serotonin-related genes may better~          contribute to the vulnerability to SB, than when they are considered independently.~        2. To assess whether the associations between these genes and SB are modulated by childhood~          trauma, life events and stress response associated with these environmental factors.~        3. To test the value of combined clinical, neuropsychological and genetic factor for~          suicide prevention, in a prospective study, in particularity impulsivity and gene gene~          interaction.~        4. To investigate the association between events in real life (using ecological momentary~          assessment) and emotional response and suicidal ideation.~      The investigators propose to use a multidisciplinary approach to answer these questions and,~     hence, be able to identify new prevention strategies for SB.~   "
54116|NCT02858622|"~     Alleviating pain in children undergoing renal transplant is extremely challenging. Large~     incisions as those of renal transplant (Gibson's incision) require special techniques of pain~     control that don't affect hemodynamics or renal function. Since the transplant incision~     doesn't cross midline; a dual-TAP block is thought to be effective in providing pain control~     in such procedure as it will anesthetize the dermatomes T6-T12, the muscles of the anterior~     abdominal wall together with the underlying parietal peritoneum.~   "
54117|NCT02858609|"~     A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the~     diagnosis in less than two hours of diarrhoea caused by known pathogens, close to the~     reception of Emergency service. In this instance 30% of patients have no etiological~     diagnosis after the POC diarrhoea tests . This lab has discovered over 200 new species of~     bacteria in humans, including vector bacteria and opened the field of large Deoxyribonucleic~     Acid (DNA ) viruses. Also, the laboratory of emerging viruses discovered many Ribonucleic~     Acid (RNA) viruses transmitted by arthropods. Based on this collection of new pathogens~     described in POC laboratory, this study proposes to expand the etiological diagnosis strategy~     of diarrhoea after POC tests.~   "
54118|NCT02858596|"~     Percutaneous endoscopic gastrostomy (PEG) is a minimally invasive procedure for long-term~     enteral tube feeding in patients with insufficient oral intake. Although peristomal site~     infection is often noted as the most common adverse event after PEG tube placements, it is~     seldom life-threatening and considered a minor adverse event. Feeding-related adverse events~     have been identified as the main cause of death after PEG, with up to 50% of postoperative~     early mortality (30 days) being attributed to aspiration pneumonia. This may be related to~     the persistence of gastroesophageal reflux (GER) of enteral feed after gastrostomy, even~     though PEG have been demonstrated to be superior to nasogastric tube feeding in terms of~     preventing GER. It has been more than a decade since semi-solid feeds were developed as an~     alternative to conventional liquid feeds to prevent feeding-related adverse events.~     Unfortunately, there is limited published literature on this topic despite the wide usage of~     this feeding method in Japan. Amidst the growing popularity of this method and the~     introduction of National Healthcare Insurance coverage for semi-solid feed prescriptions, we~     initiated a semi-solid feed protocol along with our existing post-PEG feeding protocols in~     2014.~   "
54119|NCT02858583|"~     Research question In newborn infants requiring CPR, does CC superimposed by sustained~     inflation compared to 3:1 compression to ventilation ratio improves return of spontaneous~     circulation?~      Overall objective: CC superimposed by sustained inflation will improve short- and long-term~     outcomes in preterm and term newborns.~      Hypothesis to be tested Primary hypothesis: By using CC superimposed by sustained inflation~     (CC+SI) during CPR the time needed to achieve return of spontaneous circulation (ROSC)~     compared to the current 3:1 compression to ventilation (C:V) will be reduced in asphyxiated~     newborns.~   "
54120|NCT02858570|"~     TYPE / DESIGN STUDY: Clinical trial phase II / III, randomized, double-blind, national~     multi-center, with a total of 1,644 research participants stratified into 3 groups according~     to age for starting of the primary vaccination schedule (Stratum I - 11 to 19 years, Stratum~     II - 1 to 10 years; Stratum III - less than 1 year old).~      BACKGROUND / STUDY CASE: Clinical trial phase II / III, which purpose is to evaluate~     immunogenicity, safety and reactogenicity of the vaccine against meningococcus C, conjugated~     to tetanus toxoid, developed by Bio-Manguinhos / FIOCRUZ (MenCC-Bio). The hypothesis of the~     study is that MenCC-BIO vaccine is safe and not inferior in terms of immunogenicity to the~     comparator vaccine currently available for the National Immunization Program in the child's~     immunization schedule. Thus, MenCC-Bio vaccine may meet the need for expansion of the target~     age group of vaccination in routine public health services and will be available to the~     National Immunization Program as a strategy to ensure sustainability and self-sufficiency to~     vaccination policy.~      OBJECTIVES PRIMARY: To assess the immunogenicity of MenCC Bio-vaccine in patients from 3~     months to 19 years of age, in relation to the vaccine against meningococcus C currently~     provided by the National Immunization Program. To evaluate the safety and reactogenicity of~     MenCC Bio-vaccine in patients from 3 months to 19 years old.~      SECONDARY OBJECTIVES: Evaluate the cellular immune component to meningococcal C conjugate~     vaccine in a subset of survey participants, aged 11 to 19 years.~      STUDY POPULATION: Individuals of both sexes, healthy, aged between 3 months and 19 years,~     attending the campus of Fiocruz / Rio de Janeiro, or municipal health units in Rio de Janeiro~     (living in areas covered by the municipal units health participants) that fit in the study~     eligibility criteria.~      NUMBER OF CENTRES: Two Clinical sites.~      STUDY DURATION: Estimate of 19 months.~      INTERVENTION / TREATMENT: Two intervention groups (MenCC-BIO Vaccine and Comparator) in three~     age groups, with specific vaccination schedules. For the age groups I and II are applied 2~     doses ideal interval of 6 months between them. In stratum III, are recommended 3 doses of the~     vaccine, at ages 3, 5 and 12 months of age, according to calendar of the National~     Immunization Program.~      OUTCOMES PRIMARY:~      Immunogenicity:~      Proportion of seroconversion defined by the seronegative status change (titles of~     bactericidal antibodies in children rabbit complement than 1: 8) to seropositive (titers of~     bactericidal antibodies in larger rabbit complement or equal to 1: 8) or increase 4 times of~     post vaccinal compared to pre-vacianais after the full vaccination schedule by age stratum.~      Geometric mean antibody titers (TGM) pre- and post-vaccination, for each vaccine group, and~     the ratio of these securities after the full vaccination schedule by age stratum.~      Safety and reactogenicity: Frequency and intensity of adverse events solicited and~     unsolicited, which occurred 30 days after vaccination.~      SECONDARY OUTCOME : cell detection B (CD19 +) memory phenotype (CD27 + IgD +, CD27 + IgD) in~     a subgroup of patients in the age stratum I (11-19 years old). ADDITIONAL INFORMATION age~     escalation, with interim analysis of inter-layer security and approval by the Security~     Independent Monitoring Committee of progression to the next lower age stratum.~   "
54121|NCT02858557|"~     This clinical study is designed to evaluate the effect of two dietary patterns, Mediterranean~     diet and the specific carbohydrate diet on clinical, inflammatory and microbial parameters in~     patients after pouch surgery and to assess the effect of a personal tailored diet, based on~     microbial profile, on disease outcomes and generate a predictive model for future~     interventions.~   "
54122|NCT02858544|"~     The primary goal of this study is to provide clinicians with a brief, patient self-administer~     instrument yielding a single composite score that reliably correlates with objective findings~     on standardized neurocognitive assessment for concussion.~   "
54123|NCT02858531|"~     Epidemics and infectious diseases in general, punctuate much of the activity of an emergency~     service. The impact of winter infections is particularly important to vulnerable populations~     such as infant during bronchiolitis epidemics and the elderly during seasonal influenza. Each~     year, these epidemic phenomena lead to disorganization of emergency services and healthcare~     teams by lack of anticipation and organizational measures in particular to manage the~     approval of emergency services for the most vulnerable populations requiring hospitalization.~      For 2 years, the pediatric emergency department of St Etienne University Hospital has a~     decision support tool for the periods of winter epidemics. Through a retrospective analysis~     of Passages of Emergency summary, this tool provides an estimate of infants with~     bronchiolitis flow day to day, and the availability in real time of an abnormally high flow~     of patients to pediatric emergencies. These data can help to affirm that the epidemic begins~     in this hospital.~   "
54136|NCT02858362|"~     A Phase 2 Clinical Study to Assess the Activity and Safety of Utrophin Modulation with SMT~     C1100 (ezutromid) in Ambulatory Paediatric Male Subjects with Duchenne Muscular Dystrophy~     (DMD)~   "
54137|NCT02858349|"~     Subjects with stroke will have behavioral testing and brain imaging before and after a 4-week~     control period and a 4-week exercise intervention.~   "
54125|NCT02858505|"~     Anaemia is the most worldwide health problem affecting pregnant women in both developed and~     developing countries. During pregnancy there is an inconsistent increase in plasma volume and~     haemoglobin mass.~      Iron deficiency anemia is the commonest type of anemia during pregnancy. The pregnant woman~     needs about 1000 mg of iron during pregnancy.~      Diet alone cannot give pregnant woman the daily required amount of the iron (about 27 mg/day)~     so the Centers for Disease Control and Prevention recommend that pregnant women take a daily~     supplement of 30 mg of elemental iron as a preventive dose. As most women begin their~     pregnancy with low iron stores, particularly in the second and third trimesters, so~     prevention should start as soon as possible even before pregnancy to prevent depletion of~     iron store and further Iron deficiency anemia.~      Oral iron is a cheap, effective and relatively safe line to prevent Iron deficiency anemia~     during pregnancy. The common available ferrous salts include ferrous fumarate, ferrous~     sulphate and ferrous gluconate. Unfortunately; these iron forms are associated usually with~     constipation, darkened stools, diarrhea, loss of appetite, nausea, stomach cramps, and~     vomiting.~      Iron amino acid chelates have been emerged to be used as agents for prevention and treatment~     of Iron deficiency anemia. These agents provide maximum bioavailability and maximum efficacy~     with minimal unpleasant side effects.~      Twin pregnancies have a significant role in perinatal morbidity due to increased risks of low~     birth weight and preterm birth. The iron requirement for twin pregnancy is probable double~     fold that of a singleton pregnancy and maternal hemoglobin in twin gestations is usually~     lower than in singleton pregnancy resulting in higher rate of Iron deficiency anemia.~   "
54126|NCT02858492|"~     This study is the first study with GSK2982772, a receptor-interacting protein-1 (RIP1) kinase~     inhibitor, in subjects with moderate to severe RA who are currently being treated with~     disease modifying anti-rheumatic drugs (DMARDs). The primary objective of the study is to~     investigate the safety and tolerability of repeat oral doses of GSK2982772 in subjects with~     moderate to severe RA. In addition to the PK, a number of experimental and clinical endpoints~     will be employed to obtain information on the PD, and preliminary efficacy in subjects with~     active RA. Although no formal hypothesis will be tested, these endpoints will enable a~     broader understanding of the mechanism of action and potential for clinical efficacy of~     GSK2982772 in RA. After a screening period of up to 30 days, approximately 24 subjects will~     be randomized to receive either GSK2982772 or placebo for 84 days (12 weeks), followed by a~     follow-up period (28 days). The total duration of participation in the study will be~     approximately 20 weeks from screening to the last study visit.~   "
54127|NCT02858479|"~     Neuropathic pain is a medical condition involving allodynia (painful perceptions in response~     to stimuli that normally are not) and spontaneous pain (occurring at rest, without~     stimulation).~      This pain is secondary to nervous system injury affecting the sensory system. The lesion is~     either at the nerve endings of the spinal cord or brain. It induces a loss of sensitivity and~     reorganization of brain activity.~      Previous studies in functional neuroimaging have focused on brain areas activated during~     allodynic stimuli compared to non-painful stimuli. The abnormalities have been reported, but~     it was not possible to conclude formally.~      The objective of this study is to understand the brain dysfunction that induces allodynic~     pain considering the deafferentation of each patient and possible cortical losses.~   "
54128|NCT02858466|"~     Neuropathic pain is a medical condition involving allodynia (painful perceptions in response~     to stimuli that normally are not) and spontaneous pain (occurring at rest, without~     stimulation).~      This pain is secondary to nervous system injury affecting the sensory system. The lesion is~     either at the nerve endings of the spinal cord or brain.~      It induces a loss of sensitivity and likely reorganization of brain activity that are causing~     pain and which are the subject of this study.~      Previous studies in functional neuroimaging has focused on brain areas activated during~     allodynic stimuli compared to non-painful stimuli. The abnormalities have been reported, but~     it was not possible to conclude formally. The authors failed to assess the part of the effect~     of the loss of sensory afferents (deafferentation) and the basal brain function.~      Indeed, the operation without any sensory stimulation is not known yet is the initial level~     of activity which is the benchmark for studying brain function during stimulation. The~     objective of this study is to understand what are the cortical systems of allodynic~     dysfunctional in patients compared with controls at baseline.~   "
54129|NCT02858453|"~     This study evaluates the effects of two doses of oral AQX-1125 on bladder pain and other~     urinary symptoms in subjects with interstitial cystitis/bladder pain syndrome. Participants~     will receive either 100 mg AQX-1125, 200 mg AQX-1125 or placebo for the first 12 weeks of the~     study. After 12 weeks, all participants will receive either 100 mg or 200 mg AQX-1125 for 52~     weeks.~   "
54130|NCT02858440|"~     The purpose of this study is to evaluate the immune response, safety and reactogenicity after~     receiving combined DTPa-IPV/Hib vaccine when administered as a three-dose primary vaccination~     course at 3, 4.5 and 6 months of age and as a booster dose at 18 months of age in Russian~     healthy children according to the Russian immunisation schedule~   "
54131|NCT02858427|"~     The study aims to determine the correlation between the cognitive inhibition impairment and~     the history of suicide attempt in elderly depressed patients.~   "
54132|NCT02858414|"~     This study evaluates the impact of highly active antiretroviral therapy on the size of the~     latent viral reservoirs in resting CD4+ T cells and monocytes in HIV positive patients. The~     activation state of the cells will be assessed, by measuring the activation of Akt, to~     determine its influence on the size of the viral reservoirs.~   "
54133|NCT02858401|"~     The primary objectives of this study are to evaluate the safety and tolerability vesatolimod~     (formerly GS-9620) at escalating, multiple doses in HIV-1 infected virologically suppressed~     adults on antiretroviral therapy (ART) and to evaluate the virologic effect of vesatolimod as~     measured by changes in plasma HIV-1 RNA.~   "
54134|NCT02858388|"~     The goal of the study is to investigate if the active agent of Sinuclean Nebules is~     efficacious in the treatment of pediatric exudative otitis media, comparing with saline.~      Sinuclean Nebules is a solution of cucurbitacins B,D,I,E (glycosylated triterpenes) 45 mcg,~     extracted from Ecballium Elaterium.~   "
54135|NCT02858375|"~     The study aims to assess and compare the pain in women suffering from provoked~     vestibulodynia, before treatment with botulinum injections, 3 months after treatment and 18~     months after treatment.~   "
54138|NCT02858336|"~     Background:~      Functional hypothalamic amenorrhea (functional HA) is a condition where a woman s period~     stops for a temporary time. This is due to improper function of the hypothalamus. This is the~     part of the brain that directs the whole reproductive system. Researchers want to learn more~     about functional HA. They also want to learn how diet, exercise, and other factors may change~     women s menstrual cycles.~      Objective:~      To better understand functional HA.~      Eligibility:~      Healthy women ages 18-28 years old who:~        -  Have regular periods~        -  Exercise no more than 4 hours a week~        -  Had their first period at age 11-14~      Design:~      Participants will be prescreened over the phone.~      Participants will be screened with:~        -  Blood and urine tests~        -  Medical history~        -  Physical exam.~      Participants will have 9 or 10 visits over about 3 menstrual cycles. These include:~        -  Repeat of screening tests~        -  Questionnaires~        -  Exercise test~        -  Resting energy expenditure test: Participants fast overnight before the test. They lie~          on their back under a~      canopy for a half hour.~        -  Body composition test: This is done with a dual energy x-ray absorptiometry (DXA) scan.~        -  Pelvic ultrasound~        -  For two full-day visits, an IV is inserted into an arm vein. The IV takes a blood sample~          every 10 minutes for 8 hours.~      Participants will keep logs:~        -  Menstrual cycle log~        -  Diet log for three 4-day cycles~      Participants will receive test kits to complete at home:~        -  Daily blood and urine sample~        -  Ovulation~      Participants will take a daily iron supplement. They will wear a wristband that monitors~     activity 24 hours a day.~      Participants will stick to a special diet for two 5-day periods of time. They will complete~     two 4-day exercise programs.~   "
54139|NCT02858323|"~     Background:~      Platelets are blood cells that help blood clot. Some people have what is called~     thrombocytopenia. This means they have a low blood platelet count. They need platelet~     transfusions very often. Human leukocyte antigen (HLA) alloimmunization occurs for a lot of~     these people. They become refractory. This means their platelet levels no longer increase~     after transfusions. Researchers want to study a procedure that detects HLA antibodies. They~     want to test how well it predicts how a person will respond to a transfusion. They want to~     see if it does this better than the procedure that is usually used.~      Objective:~      To study the effect of C1q-binding of Class I HLA antibodies on platelet refractoriness in~     people who get platelet transfusions. To test if this method better predicts response to~     platelet transfusion than the IgG solid phase immunoassay method.~      Eligibility:~      People enrolled on protocols 11-C-0136, 08-H-0156, 03-C-0277, 01-C-0157, or 01-C-0129 who:~      Agreed to have their specimens and data used for future research~      Had Class I HLA antibodies detected by the IgG method~      Had one or more platelet transfusions at NIH after the first positive HLA IgG antibody result~      Design:~      For each participant, researchers will look at a small portion of their archived plasma~     sample. The samples were left over from prior HLA antibody tests.~      Participants samples will be analyzed. They will be tested to see if C1q-binding HLA~     antibodies are present. This will be done by solid phase immunoassay. Results will be~     compared with the past results of the IgG method.~      Participants data will be stored in database that s protected by password.~   "
54140|NCT02858310|"~     Background:~      Human papillomavirus (HPV) can cause cervical, throat, anal, and genital cancers. Cancers~     caused by HPV have a HPV protein called E7 inside of their cells. In this new therapy,~     researchers take a person s blood, remove certain white blood cells, and insert genes that~     make them to target cancer cells that have the E7 protein. The genetically changed cells,~     called E7 TCR cells, are then given back to the person to fight the cancer. Researchers want~     to see if this can help people.~      Objective:~      To determine a safe dose of E7 TCR cells and whether these cells can help patients.~      Eligibility:~      Adults ages 18 66 with an HPV-16-associated cancer, including cervical, vulvar, vaginal,~     penile, anal, or oropharyngeal.~      Design:~      Participants will list all their medicines.~      Participants will have many screening tests, including imaging procedures, heart and lung~     tests, and lab tests. They will have a large catheter inserted into a vein.~      Participants will have leukapheresis. Blood will be removed through a needle in the arm. A~     machine separates the white blood cells. The rest of the blood is returned through a needle~     in the other arm.~      The cells will be changed in the lab.~      Participants will stay in the hospital. Over several days, they will get:~      Chemotherapy drugs~      E7 TCR cells~      Cell growth factor~      Shots or injections to stimulate blood cells~      Participants will be monitored in the hospital up to 12 days. They will get support medicine~     and have blood and lab tests.~      Participants will have a clinic visit about 40 days after cell infusion. They will have a~     physical exam, blood work, scans, and maybe x-rays.~      Participants will have many follow-up visits with the same procedures. At some visits, they~     may undergo leukapheresis.~      Participants will be followed for 15 years.~   "
54141|NCT02858297|"~     Glucosamine (GlcN) is an N-deacetyl amino sugar derived from the complete hydrolysis of~     chitosan with recently reported immunoregulatory capacity and anti-inflammatory effect and~     was administrated orally in osteoarthritis and atopic dermatitis therapy. Given the Oral~     lichen planus (OLP) T-cell-mediated pathogenesis; this drug seems to be a promising~     therapeutic option. The investigators compared clinical effectiveness of Glucosamine combined~     with two topical corticosteroid regimens to that of topical corticosteroid alone in~     symptomatic OLP and investigated therapeutic mechanism by examining treatment effect on~     expression of inhibitor kappa kinase alpha (IKKα) and interleukin-8 (IL-8) in OLP lesions.~   "
54142|NCT02858284|"~     The purpose of this study is to evaluate whether the TUG device is safe and effective in~     patients with primary open angle glaucoma or ocular hypertension.~   "
54143|NCT02858271|"~     Open-label, single-dose, Phase 1 study to assess the absorption, metabolism, excretion and~     pharmacokinetics of [14C]-AKB-9778 in healthy male volunteers~   "
54144|NCT02858258|"~     The primary objective of the the trial is to establish one of three study arms, as future~     standard based on the comparison of the investigator-assessed failure-free survival.~   "
54145|NCT02858245|"~     A prospective, open-label, and multi-centered feasibility registry.~   "
54146|NCT02858232|"~     Multiple Target Antigen Stimulating Cell Therapy (MASCT-I) is a new immunotherapy that~     dendritic cells(DC) was induced from autologous peripheral blood. The DC can then be loaded~     with antigens and re-infused. In vitro, antigen-pulsed DC can stimulate autologous T-cell~     proliferation and induction of autologous specific cytotoxic T-cells(CTL)，similarly~     re-infused. The previous research data showed that MASCT had the modest overall response and~     less adverse effects for Hepatocellular Carcinoma patients.~      The study is aimed to evaluate the safety of MASCT-1 in patients with advanced solid tumors.~   "
54147|NCT02858219|"~     The main objective of this study is to compare the efficacy of botulinum toxin injections on~     vestibulodynia pain compared to a group treated with a placebo.~   "
54148|NCT02858206|"~     This prospective, non-randomized phase II study aims to compare radiotherapy and concurrent~     nimotuzumab with concurrent chemoradiotherapy to obtain a non-inferior pCR rate and~     pathological lymph node metastases rate in premise of lower toxicities in locally advanced~     esophageal cancer.~   "
54149|NCT02858193|"~     To investigate the bioequivalence between two formulations containing~     S-carboxymethyl-L-cysteine L-lysine monohydrate salt (SCMC-lys) when administered as single~     oral dose in two consecutive study periods to healthy male and female volunteers under~     fasting conditions.~   "
54150|NCT02858180|"~     This is a multicenter study in Hepatitis C Virus (HCV) infected adult patients who also have~     advanced cardiac disease or advanced lung disease.~   "
77031|NCT02558712|"~     The purpose of this study is to compare the Technology-based Eye Care Services (TECS)~     protocol to the standard face to face ophthalmologic exam.~   "
54152|NCT02858154|"~     This is a small pilot study that will compare High Flow Nasal Cannula (HFNC) therapy to~     oxygen nasal cannula therapy on infants who have obstructive sleep apnea (OSA) and are~     scheduled for a clinically ordered sleep study called polysomnography (PSG). The HFNC~     procedure uses humidified room air delivered by nasal cannula at higher pressures and will~     test if HFNC can control OSA in infants better or as well as low flow nasal oxygen, the~     current clinical standard of care. All the infants in the study will have a brief test period~     of about 3 to 4 hours with the HFNC before participants begin their standard clinical PSG for~     titration of oxygen by nasal cannula for treatment of OSA.~   "
54153|NCT02858141|"~     This data base has been set in order to gather oncogeriatric information from elderly~     patients with pancreatic cancer who underwent an oncogeriatric evaluation.~      ONCOGEPAN database gathers data from deux institutions (Institut Paoli-Calmettes and~     Assistance Publique des Hôpitaux de Marseille) involved in Marseille SIRIC (Integrated Cancer~     Research Site).~   "
54154|NCT02858128|"~     The purpose of this study is to determine the effectiveness of whole-body diffusion-weighted~     magnetic resonance imaging (WB-DW- MRI) in detecting metastases by comparing the results with~     those from choline-positron emission tomography-computed tomography (choline-PET/CT) in~     patients with metastatic/oligometastatic prostate cancer. Patients with this disease profile~     who could benefit from treatment with stereotactic body radiation therapy (SBRT) were~     selected and their responses to these techniques were rated.~   "
54155|NCT02858115|"~     During thoracic surgery, an excessive use of fluid results in pulmonary complications.~     Dynamic fluid responsiveness predictors are not easily usable during one lung ventilation.~     The investigators hypothesized that the assessment by transesophageal echocardiography (TEE)~     of subaortic velocity time index (VTI) variation after 100 ml of crystalloid would predict~     fluid responsiveness in patients receiving one-lung ventilation.~      This retrospective, observational, single center study was from January 2014 to December~     2015. The investigators included 105 patients requiring one lung ventilation lung resection.~     The investigators analysed 39 patients presenting an acute circulatory failure. 100 ml of~     crystalloid was infused over 1-min. After an echocardiographic assessment at 1-min, remaining~     400 ml were administered over 14-min Fluid responsiveness was defined as an increase in the~     VTI above 15% after infusion of 500 ml of crystalloid.~   "
54156|NCT02858102|"~     This study aims to develop a program of systematic physical exercise maintained for at least~     12 weeks to normalize biomarkers of metabolic syndrome; improve neurocognition and social~     functioning; increase empowerment, self-esteem and self-efficacy and reduce self-stigma in~     individuals with severe mental disorder with metabolic syndrome.~   "
54157|NCT02858076|"~     Although vitreous hemorrhage (VH) from proliferative diabetic retinopathy (PDR) can cause~     acute and dramatic vision loss for patients with diabetes, there is no current,~     evidence-based clinical guidance as to what treatment method is most likely to provide the~     best visual outcomes once intervention is desired. Intravitreous anti-vascular endothelial~     growth factor (anti-VEGF) therapy alone or vitrectomy combined with intraoperative PRP each~     provide the opportunity to stabilize or regress retinal neovascularization. However, clinical~     trials are lacking to elucidate the relative time frame of visual recovery or final visual~     outcome in prompt vitrectomy compared with initial anti-VEGF treatment. The Diabetic~     Retinopathy Clinical Research Network Protocol N demonstrated short-term trends consistent~     with a possible beneficial effect of anti-VEGF treatment in eyes with VH from PDR, including~     greater visual acuity improvement and reduced rates of recurrent VH as compared with saline~     injection. It is possible that a study with a longer duration of follow-up with structured~     anti-VEGF retreatment would demonstrate even greater effectiveness of anti-VEGF for VH to~     avoid vitrectomy and its attendant adverse events while also improving visual acuity. On the~     other hand, advances in surgical techniques leading to faster operative times, quicker~     patient recovery, and reduced complication rates may make prompt vitrectomy a more attractive~     alternative since it results in the immediate ability to clear hemorrhage and to perform PRP~     if desired, often as part of one procedure. This proposed study will evaluate the safety and~     efficacy of two treatment approaches for eyes with VH from PDR: prompt vitrectomy + PRP and~     intravitreous aflibercept injections.~   "
54158|NCT02858063|"~     -  Selection of patient and preparation of questionnaires~        -  Presentation of the study by the doctor~        -  Verbal consent of participants (patient and Partner)~        -  Delivery of booklets~        -  Response to documents (questionnaires and written consent) at home, send by mail~   "
54159|NCT02858050|"~     The study will look at real-times adhernce monitoring with Portal-724 MEMS cap. It integrates~     medication bottle, Smart Cap, Pill Dispenser, Embedded Computer, Embedded Cellular Modem and~     Tamper Proof apparatus. This device is capable of transmitting pill dispensing events from~     the patient's home to the Cloud over Cellular and IP networks. The transmission is done in~     real time if cellular coverage is above 1-bar, but if cell is not available or if the signal~     is below threshold, then the device Store-and-Forward feature is automatically activated..~     Patient will be randmized to real-time monitoring or to have monitoring data download monthly~     at each study visit while taking hepatitis C medications~   "
54160|NCT02858037|"~     HIV Open-label Prevention Extension (HOPE).~   "
54161|NCT02858024|"~     A Two-Cohort, Open-Label, Randomised, Three-Period Crossover Trial In Healthy HIV-Negative~     Women To Assess The Effect Of Menses And Tampon Use On The Pharmacokinetics Of Dapivirine,~     Delivered By Dapivirine Vaginal Ring-004, Containing 25 Mg Of Dapivirine~   "
54182|NCT02857751|"~     The current study evaluates psychological and physical health outcomes for active-duty~     service members following participation in an established surf therapy program. Participants~     complete assessments before and after the surf therapy program, as well as brief assessments~     before and after each surf therapy session.~   "
54183|NCT02857738|"~     Evaluation of the effectiveness of a sunscreen product by determining its Sun Protection~     Factor (SPF) on the skin of human subjects.~   "
54184|NCT02857725|"~     Evaluation of the effectiveness of a sunscreen product by determining its Sun Protection~     Factor (SPF) on the skin of human subjects.~   "
54234|NCT02857062|"~     The investigation will evaluate, under dermatological control, the cutaneous in-use tolerance~     of E45 Eczema Repair Emollient with two or three times daily application, over a period of~     two weeks on children and babies with dry/atopic and very dry/atopic skin.~   "
54162|NCT02858011|"~     In the last two decades, cash transfer (CT) programs have emerged as a popular approach to~     long-term poverty alleviation. While the main goal of cash transfer programs is to reduce~     poverty, they also have the potential to improve many development outcomes, such as health~     and education.~      While many studies, mainly in Latin America and Asia, have investigated the impacts of CTs on~     poverty and food security and have, for the most part, found positive impacts, less is known~     about the impacts of CTs in Africa south of the Sahara, and, in particular, West Africa.~     Moreover, despite the fact that cash transfers have been shown to lead to decreases in~     poverty, improvements in household food security, and increases in health service~     utilization, impacts on children's nutritional status (including anthropometric measures) are~     generally small (Manley, Gitter, and Slavchevska 2013). Consequently, policymakers and~     governments are left with the question of how to design social safety nets, such as cash~     transfers, to achieve greater impact on diet quality, health, and nutrition.~      The overall goal of this research is to generate evidence and knowledge on an integrated~     program implemented by the Government of Mali that includes a combination of cash transfers~     and targeted nutrition interventions. The information generated will inform program~     implementers and policymakers about best options to improve food security and nutrition among~     vulnerable groups and individuals in West Africa. Specifically, the main objectives of the~     research are~        1. To provide evidence on the contribution of integrated social transfer programs to~          enhancing household welfare, food security, dietary diversity, and maternal and child~          nutrition in West Africa.~        2. To test different features and combinations of cash transfers with targeted nutrition~          interventions, and assess their impact on food security and maternal and child nutrition~          and health outcomes in Mali.~        3. To generate knowledge regarding the pathways of impact of these different program~          packages, identify the most effective and efficient modalities in the context of Mali,~          and derive lessons learned for other countries in the region.~      The research entails two study designs: i) a repeated cross-sectional survey (baseline,~     midline and endline) in a sample of 1,440 children between 6 and 24 months of age, mainly to~     asses the program's impact on child nutrition and health outcomes; ii) a panel study~     following a cohort of 2,880 children over 3 years mainly focusing on the evaluation of~     household welfare outcomes. The study will be conducted in the 96 communes where the~     Jigisemejiri program is being implemented, situated in 5 regions of Mali: Sikasso, Koulikoro,~     Segou, Mopti and Kayes.~   "
54163|NCT02857998|"~     A Phase I, Open-label, Dose-escalation Study of the Safety and Pharmacokinetics of HMPL-523~     in Patients With Relapsed or Refractory Mature B-cell Neoplasms~   "
54164|NCT02857985|"~     The size of the infarct is particularly important prognostic marker. It is clearly~     established that the extent of the infarct is not only correlated to mortality, but also~     long-term adverse events. The evaluation of the infarct size at the acute phase of the~     disease is therefore an essential clinical tool to adapt the immediate treatment and~     follow-up of patients. It is therefore crucial to have techniques that are effective,~     precise, reproducible, and easily performed during the acute phase to quantify the size of~     the infarct following angioplasty. Myocardial scintigraphy and cardiac MRI have been the~     standard examinations for the evaluation of infarct size. However, these exams are difficult~     to perform during the acute phase of the infarct owing to difficulties in monitoring unstable~     patients and the limited availability of the apparatus. It is for this reason that the~     investigators would like to investigate the rotational angiography (RA), which is comparable~     to a scanner in its mode of action but does not require transfer of patients as performed~     using the same apparatus that used for diagnostic coronarography and therapeutic angioplasty.~     RA is a radiological technique that uses the system employed for coronagraph, and consists~     rotating the fixed C-Arm around the patient and acquisition of a series of images that are~     then reconstituted. The investigators propose to evaluate the size of the infarct using RA in~     comparison with cardiac MRI (standard examination) performed as soon as possible after RA and~     the investigators hope to demonstrated that RA allows the measurement of an infarct as~     precisely as cardiac MRI.~   "
54165|NCT02857972|"~     General objective:~      To assess the preference and performance in terms of satisfaction and acceptability as well~     as safety profile of a novel innovative design of menstrual hygiene device (Wondaleaf®)~     during the night for menstruating women by comparing it to prior experience of the usual~     hygienic product for menstrual control, i.e. sanitary pads.~      Specific objectives:~        -  To determine the preference of participants between Wondaleaf® and usual sanitary pads~          as a night use menstrual hygiene product.~        -  To determine the satisfaction of participants towards Wondaleaf® and usual sanitary pads~          as a night use menstrual hygiene product.~        -  To determine the acceptability of participants towards Wondaleaf® as a night use~          menstrual hygiene product.~        -  To determine the safety profile of the Wondaleaf®.~   "
54166|NCT02857959|"~     The purpose of this study is to observe the serological response to 1 or 3 weekly doses of~     benzathine penicillin G in patients with early syphilis.~   "
54167|NCT02857946|"~     An open label randomized, single dose, two-way crossover bioequivalence study to determine~     the bioequivalence of Linagliptin from Prevaglip 5 mg tablets(Eva pharma for Pharmaceuticals~     & Medical Appliances, Egypt) and Trajenta 5 mg tablets(Boehringer Ingelheim International~     GmbH, Germany) after a single oral dose administration of each to healthy adults under~     fasting conditions~   "
54168|NCT02857933|"~     The purpose of this study is to determine the optimal frequency and intensity of physical~     therapy for children with cerebral palsy aged 6 to 24 months of age. Participants will be~     randomly assigned to one of three groups: daily, intermediate, or weekly physical therapy.~     Short and long term effects will be evaluated to determine the best 'dose' of rehabilitation~     for children with cerebral palsy, including frequency (number of sessions per week and the~     number of weeks), intensity (how hard the patient works), and time (how many total hours) of~     rehabilitation treatment.~   "
54169|NCT02857920|"~     The aim of this study is the safety and efficacy of Bevacizumab plus natural killer (NK)~     immunotherapy to many kinds of recurrent solid tumors.~   "
54170|NCT02857907|"~     The aim of the study is to investigate the impact of Anti-Thymocyte Globulin (ATG) on immune~     senescence. Markers of immune senescence expression is assessed in a prospective cohort of~     renal transplant recipients the day of transplantation and one year after renal~     transplantation.~   "
54185|NCT02857712|"~     SGCs are rare (less than 1% of head and neck cancers) and include many malignant histotypes.~     SGCs are treated mainly with surgery, followed by radiotherapy in selected cases.~     Chemotherapy is reserved for palliative treatment of metastases or local recurrence but~     results in term of response rate are very low. Adenoid cystic cancer (ACC) is the most common~     SGC histotype observed in metastatic subjects while the other histotypes (non-ACC) such as~     mucoepidermoid cancer (MEC), salivary duct gland cancer, adenocarcinoma, myoepithelial~     carcinoma are more uncommon. A phase II trial with sorafenib carried out in 37 subjects (19~     ACC and 18 non-ACC) with recurrent and/or metastatic SGCs showed a response rate of 16% (11%~     in ACC and 22% in non-ACC). In preclinical models, VEGF seems to contribute to tumor~     aggressiveness and to distant metastatization of SGCs, in particular in ACC and MEC.~     Remarkably three confirmed partial responses, one ACC, one renal cancer and one lung cancer,~     on 36 patients were observed in a phase I study with Inlyta, a potent VEGFR~     specific-inhibitor approved by FDA as second line treatment for renal cancer. Based on these~     data, we want to test Inlyta in patients with relapsed and/or metastatic SGC.~   "
54171|NCT02857894|"~     Polypoidal choriodal vasculopathy (PCV) is an ophthalmologic disease, characterized by~     vascular abnormalities of the walls of small choroidal vessels, reproducing the specific~     aspect of polyps (cluster aspect). PCV is one of the boundary-forms of age related macular~     degeneration.~      These vasculopathies can be idiopathic. Following the radiotherapy treatments of active and~     occult-typed neovessels in Age-Related Macular Degeneration (ARMD), 10% of the patients would~     present typical polypoidal vasculopathic lesions. These polypoidal secondary lesions have~     been induced by radiotherapy treatment and may show an increased sensibility to radiation in~     these patients.~      Such an increase of radiosensibility is noticed in ataxia telangiectasia syndrome, in~     relation to the ATM gene mutations. The secondary or idiopathic polypoidal vasculopathic~     lesions are to be brought closer to telangiectasias in Ataxia Telangiectasia. Considering the~     iatrogenic component of radiotherapy in the secondary forms of ataxia telangiectasia, it~     seems legitimate to search for predisposing variants to polypoidal vasculopathies in the ATM~     gene.~      Considering the frequency of PCV worldwide, it seems important to identify the predisposing~     genetic factors of the ATM gene. These biomarkers to the pathology might enable us to offer~     prevention (reinforced protection against radiations, including light) and to develop~     therapeutics (recruitment of other kinases, ATM's partners, in the stability and cellular~     control of DNA).~   "
54172|NCT02857881|"~     Keratoconus is a symmetrical, bilateral, non-inflammatory, idiopathic corneal pathology,~     characterized by a progressive corneal thinning. This disease leads to a bombing of the~     cornea, inducing a strong corneal astigmatism, responsible for a loss of visual acuity~     sometimes very important, non-correctable by lens of glasses. Collagen Cross-Linking (CXL)~     and simple corneal de-epithelization are two common surgical technics aiming to slow the~     progression of this pathology. They consist in rigidifying the corneal structure in order to~     stabilize its deformation progression. Even though these technics are commonly performed,~     none of these strategies has proven their efficiency. The effects of CXL can be due to the~     superficial scarring reaction as well as the effects of corneal remodeling induced by the~     de-epithelization phase during a CXL procedure, and not due to the covalent links between~     collagen and fibrils, formed by the biochemical reaction resulting from the UV-A exposition~     in the presence of Riboflavine De-epithelization may be an equally effective treatment, when~     compared to CXL, but without long term secondary effects. Its association with a therapeutic~     photokeratectomy (PKT, surgical technic used to regulate the corneal surface, and eliminate~     its opacities in order to recuperate the transparency of the cornea) will aim to improve the~     regularity of the anterior corneal surface, thus allowing a better epithelial attachment~     (adhesion) and may allow a stromal inflammatory reaction, favorable to the improvement of~     corneal biomechanics. PKT is a reliable technic; however it has not yet proven its efficiency~     in the treatment of keratoconus.~      The purpose of this study is to describe the effects of de-epithelization associated with a~     therapeutic photokeratectomy in patients with evolutive keratoconus, by showing the~     proportion of patients who lost the evolutivity of their keratoconus, after 6 months and 1~     year, after an intervention of de-epithelization associated with therapeutic~     photokeratectomy.~   "
54173|NCT02857868|"~     The main purpose of this study is to evaluate the effect of varying degrees of impaired~     hepatic function (by Child-Pugh classification) on the pharmacokinetics (PK) of ABL001 after~     a single oral dose.~   "
54174|NCT02857855|"~     The aim of this prospective randomized controlled trial is to evaluate the impact of high~     concentration supplemental postoperative oxygen therapy on short-term and long-term results~     of liver transplantation, particularly with respect to infections and biliary complications.~   "
54175|NCT02857842|"~     This study explores whether patients hospitalized with chronic obstructive pulmonary disease~     (COPD) exacerbation may have fewer days with prednisolone and with the same treatment effect~     by controlling the treatment by daily measurements of eosinophils.~   "
54176|NCT02857829|"~     Achieving optimal concentration during cognitively demanding tasks is of immense human value.~     Despite our understanding of the important role that attention, working memory, and fluid~     intelligence play in professional success, and the huge individual differences in these~     constructs, the modulation of these cognitive domains has not been rigorously studied. From~     the widespread use of caffeine, to the more questionable and increasing use of prescription~     medications to achieve peak attention, the tremendous interest in achieving cognitive~     performance has driven individuals to experiment, often with prescription and illegal drugs.~     Herein, we aim to standardize and extend the study of attention modulating substances, to~     identify blends that achieve safe enhancements in attention and working memory. Specific to~     this proposal, we aim to develop CAF+, a blend of natural and generally regarded as safe~     compounds to improve attention and working memory in normal, healthy individuals. CAF+ is~     composed of caffeine (100 mg), L-theanine (200 mg), vinpocetine (40 mg), L-tyrosine (300 mg),~     pyridoxine (0.06 mg), and cobalamin (20 mg).~   "
54177|NCT02857816|"~     To evaluate the NURO system for the treatment of OAB in drug naïve patients.~   "
54178|NCT02857803|"~     Virtual Reality allows the integration of both cognitive and motor rehabilitation in a more~     ecologically valid context. The purpose of this study is to determine whether this~     methodology has more impact on stroke rehabilitation than a paper and pencil personalised~     program and conventional therapy, which is motor-focused.~   "
54179|NCT02857790|"~     Percutaneous coronary intervention (PCI) with adjunctive high speed rotational atherectomy~     (HSRA) is commonly used to treat complex and calcified coronary artery stenoses.~     Theoretically, HSRA may have deleterious effects on the coronary microcirculation and result~     in peri-procedural myocardial infarction (Type 4a MI).~      This study is assessing the effects of HSRA PCI using serial multi-parametric stress~     perfusion cardiac magnetic resonance imaging (CMR) (1.5 Tesla MAGNETOM Avanto, Siemens~     Healthcare). The study will prospectively enrol up to 75 patients (minimum completed cohort~     of 50 patients) undergoing elective HSRA PCI and performing multi-parametric CMR at 3~     time-points: before HSRA, 1 week post-HSRA, and 6 months post-HSRA. Myocardial perfusion will~     be assessed using pharmacological stress with intravenous adenosine (140 micrograms/kg/min)~     at each time point. High-sensitivity cardiac troponin (hsTn) and ECGs will be performed~     post-HSRA.~   "
54180|NCT02857777|"~     The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of~     intranasally administered esketamine in elderly Japanese subjects and healthy younger adult~     Japanese subjects.~   "
54181|NCT02857764|"~     The purpose of the study is to estimate the incidence of below-knee lower extremity~     amputation in type 2 diabetes mellitus (T2DM) participants newly exposed to sodium-glucose~     co-transporter 2 inhibitors (SGLT2i)/ non-SGLT2i antihyperglycemic agents (AHA) overall and~     in the subgroup with high cardiovascular (CV) risk and to compare the hazards of below-knee~     lower extremity amputation in canagliflozin new users versus non-SGLT2i AHA new users.~   "
54504|NCT02853539|"~     Low bone mineral density (BMD) is commonly reported in patients receiving home parenteral~     nutrition (HPN). Denosumab represent a new drug, which helped to prevent osteoclast. The aim~     of the study was to assess its value in chronic intestinal failure patients.~   "
54186|NCT02857699|"~     A prospective cohort of 250 patients with solid tumours included in phase I clinical trials~     of targeted agents will be enrolled. Patients will be treated with MTA in mono therapy or in~     association with chemotherapy or other targeted agents in 4 large phase I centers.~      Patients from trials investigating chemotherapy alone will not be included. Quality of life~     will be assessed during the treatment period.~   "
54187|NCT02857686|"~     The safety and effectiveness of the mini-dose Bier block, a technique of i.v. regional~     anesthesia using low-dose lidocaine (1.5 mg/kg) without routine premedication, was evaluated~     in the emergency department treatment of pediatric upper extremity fractures and~     dislocations.~   "
54188|NCT02857673|"~     Child maltreatment, particularly neglect, disproportionally affects low-income children with~     special health care needs (CSHCN) and has serious short and long-term consequences.~     Currently, few replicable, evidence-based preventive services exist for such families,~     particularly within the context of the patient-centered medical home. Child Abuse Prevention~     Problem Solving (CAPPS), a targeted problem solving intervention that addresses key risk and~     protective factors for child neglect, has the potential to improve key parenting skills and~     overall wellbeing, ultimately improving outcomes for high-risk children. This study is a~     multi-center randomized controlled efficacy trial of CAPPS to determine the impact on child~     neglect, adherence to recommended medical care, and family stressors and strengths.~   "
54189|NCT02857660|"~     The aim of the study is to determine the effect of 16 weeks of Whole~     Body-Electromyostimulation (WB-EMS) and/or protein supplementation on Sarcopenic Obesity (SO)~     in community dwelling male subjects 70+ with SO .~      108 eligible men will be randomly assigned to either a (1) WB-EMS and Protein (2) Protein (3)~     sedentary control group.~      WB-EMS will be applied 1,5 x 20 min per week (i.e. 3 sessions in two weeks) with bipolar~     current, 85 Hz in an intermitted mode (4 s - 4 s of rest). Protein supplementation will be~     adjusted to dietary intake in order to reach a total protein intake between 1,5 - 1,7g/kg~     body-mass/d . Primary study endpoint will be the Sarcopenia Z-Score~   "
54190|NCT02857647|"~     An interventional prospective study on 200 bariatric surgery candidates from the Assuta~     Medical Center (AMC). The first 100 patients will be assigned to the control group and the~     later 100 patients will be assigned to the experimental group. All the participants will~     receive standard care, and only those participants who will assigned to the experimental~     group will be asked to watch a videotaped lecture of 30 minutes 1-2 weeks prior to the~     surgery date. The videotaped lecture will include information and guidelines of bariatric~     surgery preparation. All participants will complete Bariatric surgery knowledge questionnaire~     and The state-trait anxiety inventory (STAI) questionnaire at the bariatric committee and~     once again at the pre-surgery clinic which take place 1-10 days pre-surgery.In addition, 20~     participants will be recruited to a pilot study for the validation of the Bariatric surgery~     knowledge questionnaire.~   "
54191|NCT02857634|"~     Bladder cancer is one of the most common cancer worldwide and the second most frequent~     urological cancer. The photodynamic diagnosis technique (PDD) currently used (Hexvix®) has~     improved tumor detection but with a high false positive rate. Indeed, the main limitation of~     the PDD is its lack of specificity, ranging from 35 to 66%. The association of this technique~     with new technologies such as the Cellvizio Dual Band featuring simultaneous dual wavelength~     illumination and detection, could improve the identification of tumoral lesions. The~     objective of this study is to demonstrate the efficacy of Cellvizio dual band technique for~     the diagnosis of tumors bladders.~   "
54192|NCT02857621|"~     Lymphedema is a condition characterized by excess accumulation of protein rich tissue fluid~     in interstitial spaces. It is a progressive chronic disease and without appropriate~     management may result in serious complications. In Israel, patients are referred to~     physiotherapists certified in treatment for lymphedema. According to the International~     Society of Lymphology (ISL) the best treatment is a holistic, multidiscipline approach.~     Amongst the different methods of lymphedema management, the use of compression is the only~     treatment that has shown to be effective in randomized controlled trials.~      The ISL recommends that patients with lymphedema in the lower limb ought to bandage their leg~     with multi-layer bandaging on a daily basis for a period of two to four weeks. A new~     classification system for compression bandages was recommended; pressure of <20 mmHg was~     categorized as mild, 20-40 mmHg as medium, 40-60 mmHg as strong and ≥60 mmHg as very strong.~     In patients with leg edema, bandages with strong pressure were shown to be the most~     effective. However, in the presence of a venous ulcer on a lymphatic leg, pressure between 35~     and 45 mmHg is the widely accepted range for sufficient and safe compression. The use of~     measurement instruments is currently the only realistic method for determining the actual~     pressure achieved beneath the bandage. However, it is neither economical nor feasib¬le nor is~     it realistic in terms of time.~      Recent studies show that many healthcare professionals use inadequate sub-bandage pressure.~     No study so far has focused on therapists that are trained in lymphatic treatment. In spite~     of correct pressure bandaging importance, the question whether physiotherapists succeed in~     correctly applying it is left unanswered. The main purpose of this study is to evaluate the~     pressure applying efficiency in multi-layer bandaging among physiotherapists in Israel who~     treat lymphedema.~      34 physiotherapists trained in lymphatic treatment will be recruited for this research. Each~     volunteer will receive a questionnaire concerning their self-perceived competence in the~     application of compression bandages. Afterwards, two practical trials will be held a week~     apart in which the subjects will be asked to apply bandages using strong and medium pressure.~     Using PicoPress®, pressure will be measured directly after bandaging and two hours later. Our~     hypothesis is that the majority of therapists will properly apply medium or strong pressure~     on the lower limbs.~   "
54193|NCT02857608|"~     Prospective, open-label, within-subject, multi-center pilot study of Lymphoseek in the~     detection of lymph nodes in subjects with known squamous cell carcinoma of the anus.~   "
54194|NCT02857595|"~     Behavioral lifestyle treatment for obesity produces clinically significant weight loss and~     corresponding improvements in disease risk and severity when delivered via in-person group~     and/or individual treatment sessions. Online versions have been developed in order to reduce~     costs. These programs typically include weekly weight loss lessons and tailored feedback on~     patients' weight loss progress. However, online programs often produce suboptimal outcomes~     compared to programs delivered in-person due to insufficient adherence to prescribed~     behavioral strategies, and a lack of objective methods for behavioral self-monitoring to~     support adherence. One approach to monitoring and improving adherence involves tracking~     patients' weight loss progress on a personalized nomogram (i.e., graph). The nomogram is~     based on a dynamic energy balance equation and depicts the expected weight loss over time if~     the participant is adherent to a prescribed goal for caloric intake and physical activity. A~     complementary approach to measuring and intervening on adherence involves the use of mobile~     technology to monitor eating behavior. The Bite Counter is a wrist-worn device similar to a~     wristwatch that measures the timing, frequency, rate, and duration of eating events by~     monitoring the wrist roll motion that occurs when food is brought to the mouth. By using~     mathematical models to calibrate the Bite Counter to the weight loss nomogram, it may be~     possible to identify the optimal number of bites that any given patient should take each day~     in order to facilitate weight loss. The purpose of the proposed study is to conduct a small~     randomized controlled trial to test the feasibility, acceptability, and preliminary efficacy~     of adding weight loss nomograms and the Bite Counter to an established online weight loss~     program. A sample of 30 participants with overweight/obesity will be randomly assigned in~     equal proportions to one of three 12-week weight loss programs: (a) online behavioral weight~     loss treatment alone (OBWL), (b) online behavioral weight loss treatment plus the provision~     of weight loss nomograms with weekly feedback tailored to the nomogram (OBWL+N), or (c)~     online behavioral weight loss treatment plus the provision of weight loss nomograms with~     weekly feedback tailored to the nomogram and provision of a Bite Counter that can be used to~     alert participants when they are approaching their maximum number of prescribed bites per day~     (OBWL+N&BC).~   "
54195|NCT02857582|"~     Patients who have received antibiotics and thereafter developed diarrhea are investigated for~     presence of Clostridium difficile toxin. Primary treatment is given with oral~     metronidazole/vancomycin. In case of relapse, secondary treatment is given with either~     cultured gut microbiota rectally or oral vancomycin in sequence. In those cases where~     secondary treatment with vancomycin fails cultured gut microbiota is given as final~     treatment. As an extension treatment, all failures were treated with cluttered gut microbiota~     through the upper route. In both cases As an alternative cultured gut microbiota may be given~     via the duodenal route. Follow-up is carried out after 7, 30 and 90 days with interview and~     stool collection for analysis of Clostridium difficile.~   "
54196|NCT02857569|"~     The study aims to evaluate the 6 month-treatment tolerance defined as the immune related~     grade 3-4 adverse event-free survival of the combination therapy IT ipilimumab + IV~     nivolumab.~      The IV ipilimumab + IV nivolumab (same doses than in Phase I) arm will be used as an internal~     control to interpret the results obtained in the IT ipilimumab arm.~   "
54197|NCT02857556|"~     The principal objective of this study is to qualify markers of oxidative stress in~     inflammatory cells (monocytes) in patients with stage 3 kidney failure (diabetic or not), and~     patients with end-stage kidney failure (diabetic or not), who require dialysis. The~     evaluation of these markers will be done by the activation and localization of proteins~     implicated in vascular tone and oxidative stress in monocytes, correlated with the~     distribution of cholesterol sphingomyelin within planar rafts and caveolae. The aim is to~     describe their evolution under treatment, which could lead to interventional studies.~   "
54198|NCT02857543|"~     The purpose of this research is to investigate the effects of a PB no- added-fat and the AHA~     and MED in obese (BMI >95%) children ages 9-18 with hypercholesterolemia (>169 mg/dl) and a~     parent or guardian. Eligible patients will be identified by utilizing the Pediatric Obesity~     Registry. When possible, in-person discussions or phone calls with their primary or tertiary~     care physicians will introduce eligible patients and their parents to the study. All eligible~     patients and parents will receive letters describing the study and requesting their~     participation. Subjects can choose not to participate in the study, and their health care~     will not be affected in any way. Subjects not participating will be asked if they are willing~     to answer a brief questionnaire about why they chose not to participate. The proposed study~     will be carried out for a total of 52 weeks. The investigators expect to recruit a total of~     180 participants (30 children and 30 parents/guardians in each of the three groups). Each~     child and parent/guardian pair will be randomly assigned to either PB no-added-fat, AHA or~     MED.~   "
54199|NCT02857530|"~     Efficacy and Safety of Recombinant human thrombopoietin in patients with severe aplastic~     anemia and very severe aplastic anemia, a randomized, double-blind, placebo-controlled, II~     phase, multi-center clinical research.~   "
54200|NCT02857517|"~     The purpose of this study is to evaluate the efficacy of intravitreal anti-vascular~     endothelial growth factor (anti-VEGF) therapy as primary treatment for ICNV.~   "
54201|NCT02857504|"~     One lung ventilation (OLV) has become a standard procedure for the vast majority of~     interventions in pulmonary surgery. It is used in both techniques: thoracotomy and~     videothoracoscopy (VATS).~      OLV can be provided by double lumen tube (DLT) with or without the hook. In our study the~     investigators want to find out if there is any advantage with one or another.~   "
54202|NCT02857491|"~     Certain percent of the eyes with proliferative diabetic retinopathymay require pars plana~     vitrectomy (PPV) due to vitreous haemorrhage, proliferative membrane, and tractional retinal~     detachment. This study will compare intravitreal injection of anti-vascular endothelial~     growth factor (ranibizumab) versus sham injection before vitrectomy for PDR. The main focus~     is to see if pre-operative injection of ranibizuman can reduce peri-operative hemorrahge~     related complications.~   "
54203|NCT02857478|"~     The objective of this study was to assess the safety and appropriateness of a sunscreen~     product for use on sport users, under supervised outdoor-use conditions. The study was~     conducted under the supervision of a Board-Certified Dermatologist at an outdoor, chlorinated~     swimming pool facility.~   "
54204|NCT02857465|"~     To assess the efficacy of epidural dexamethasone administration, compared to placebo, in~     reducing local anesthetics consumption during labor epidural analgesia in parturient women~   "
54205|NCT02857452|"~     The evaluation of lupus patients must include several approaches, in particular disease~     activity and quality of life.~      The Systemic Lupus Activity Questionnaire (SLAQ) is a validated self-questionnaire to~     evaluate disease activity. It has the advantage of being inexpensive, easy to use in large~     cohorts and has been used in several studies. It has never been validated in French. The~     Lupus Quality Of Life (LupusQoL) is a self-questionnaire to evaluate quality of life and is~     specific to systemic lupus erythematous; it was developed from interviews with patients.~      This tool, validated in a British population, has never been validated in French.~   "
54206|NCT02857439|"~     What combination of ≤ 6 clinical variables will give the highest specificity for indicating~     significant shoulder injuries (fractures or dislocations) with a set sensitivity of ≥ 97%?~      Although shoulder trauma is a common injury, there is no clinical decision rule to determine~     the necessity for radiography for these traumas. With this trial the investigators aim to~     develop such a rule to reduce the amount of radiographs without missing any significant~     injuries.~      The primary objective is to compose a set of clinical diagnostic criteria predictive of~     shoulder fractures or dislocations that would reduce the amount of radiographs without~     missing any significant injuries. A second objective is to determine if the clinical decision~     rule is applicable for triage use.~   "
54207|NCT02857426|"~     The purpose of this study is to determine whether Nivolumab is effective in the treatment of~     Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed/Refractory~     Primary Testicular Lymphoma (PTL)~   "
54208|NCT02857413|"~     The aim of this study is the evaluation of the frequency of xerostomia and their management~     after radiotherapy in head and neck cancer.~      The quality of life of these patients is also analysed with European Organization for~     Research and Treatment of Cancer Quality of life Questionnaire H&N35 (EORTC QLQ H&N35).~   "
54285|NCT02856386|"~     Micronutrients missing in the diet may assist in supporting digestive health in children with~     chronic GI issues. This study will monitor changes in symptoms associated with digestive~     problems in children provided with a dietary supplement that will be taken in conjunction~     with the standard of care.~   "
54209|NCT02857400|"~     Prospective, open label, randomized and multicentric study evaluating the efficacy of an~     organized consultation return home compared to a current standard of care in patient~     hospitalized due to metastatic solid tumor cancer.~      Subject will be randomized (1:1) as described below :~      • Arm A (standard) : current standard of care ; connection documentation faxed to GP (~     General practitioner) on the day of patient's discharge Arm B (experimental) : CREDO standard~     of care, organized consultation return home between patient, GP DESC (diploma of~     complementary specialized study) and patient's referent GP~   "
54210|NCT02857387|"~     Atherosclerosis and aging are associated to the raise of biochemical alterations of proteins~     grouped under the name of  non-enzymatic post-translational modifications . They often~     correspond to the irreversible binding of glucose or other oses (glycation) or urea~     derivatives (carbamylation) on proteins and lead to the formation of complex compounds~     (post-translational modifications derived products, PTMD) that can accumulate in tissues and~     be responsible for deleterious effects. The specific role of these compounds in the~     pathophysiology of aging and atherosclerosis remains unknown, as are the molecular and~     cellular mechanisms implicated.~      This project is based on the hypothesis that non-enzymatic post-translational modifications~     may cause changes in the genesis of complication of coronary atherosclerosis and that PTMD~     could therefore constitute relevant biomarkers in this specific clinical situation.~      To explore these potential new biomarkers, the investigators designed a study in patients~     having experienced an acute coronary syndrome and followed during a year. The concentrations~     of PTMD assayed at 0, 1, 3, 12 months, will be correlated to clinical (severity and~     evolution) and paraclinical (cutaneous autofluorescence) data and the effect of cardiac~     rehabilitation will be assessed.~      This should help to identify new (and non-traditional) biomarkers of coronary heart disease~     and determine some of the implicated pathophysiological mechanisms.~   "
54211|NCT02857374|"~     This pilot clinical trial studies intravital microscopy in identifying tumor vessels in~     patients with stage IB-IIIC melanoma undergoing sentinel lymph node biopsy. By examining~     sentinel lymph nodes through intravital microscopy before they are removed, doctors may learn~     specific information regarding how melanoma may spread to lymph nodes and other sites of the~     body.~   "
54212|NCT02857361|"~     The study will look at whether it is preferable to administer two wafers simultaneously or~     separately.~   "
54213|NCT02857348|"~     The objective of this study is to compare the efficacy of a video game designed to~     recalibrate physician heuristics in trauma triage with a standard educational program.~   "
54214|NCT02857335|"~     15 patients, Ages 8-17 who were diagnosed in the recent years with Idiopathic increased~     intracarnial hypertension (IIH) went through a battery of neurocognitive tests to establish~     whether there was any affect of the disease on their cognitive function~   "
54215|NCT02857322|"~     The experimental strategy is to develop a specific device about the anesthetic and surgical~     acts for a subject with a documented psychiatric condition and to benefit from surgery. This~     device is based on 3 stages: pre-operative phase, Phase perioperative and postoperative~     phase. A nurse anesthetist will come into contact with the subject the day before surgery.~     This contact will be concomitant with the pre-anesthesia visit. She explained about the~     general organization of the arrival in the operating room. The interview will be a minimum of~     15 minutes and beyond if necessary. This will be accompanying this the next day in the~     operating room in order to optimize its hospitality and installing the block, guide the~     subject through all the steps before falling asleep. Finally, even accompanying will be~     present upon awakening the subject in the recovery room.~   "
54216|NCT02857309|"~     The study is designed to substantiate the efficacy of Cardiac Contractility Modulation (CCM)~     in the heart failure population with ejection fraction ranging between 25 and 45%. The study~     is designed in an adaptive manner to ensure proper statistical significance and power of the~     primary efficacy evaluation.~   "
54217|NCT02857296|"~     The research project aims to analyze the implementation of a new health care system -~     alternative device to hospitalization and crisis home for people without home - whose~     objective is to provide the homeless and suffering from severe psychiatric disorders adequate~     care to prevent situations from seeking care or complication of their disease. This device,~     if it has the administrative and legal structure of the Twin Stop Health Care (LHSS), is~     based on the original concept of Soteria House. This will build tools for evaluating the~     performance of care device by a process evaluation describing and analyzing what activity~     involves the device, This research seeks to analyze the experimental device in the early~     stages of its implementation. The observation and analysis of the program period will adjust~     the management arrangements of the device. The data and conclusions from this research will~     identify the contributions and benefits of such a device and analyze the difficulties~     encountered in its implementation.~   "
54218|NCT02857283|"~     To investigate if low level ozone exposure will cause measurable inflammation in nasal cells.~   "
54219|NCT02857270|"~     The purpose of this study is to determine the safety of an extracellular signal regulated~     kinase (ERK1/2) inhibitor LY3214996 administered alone or in combination with other agents in~     participants with advanced cancer.~   "
54220|NCT02857257|"~     Patients with irritable bowel syndrome (IBS) are treated with microbiota from a human~     intestinal anaerobic sample cultured for decades. Patients are recruited consecutively with~     symptoms of IBS and serve as their own controls. After an observation time of 4 weeks,~     patients are recruited for a 1-week run-in and then given the cultured fecal microbiota by~     the duodenal route via gastroscopy. Two treatments are given within a 1-week interval.~     Assessment of symptoms are made before and 4 weeks after the last treatment (at 6 weeks).~     Additionally, fecal samples are collected for bacterial 16S ribosomal ribonucleic acid (rRNA)~     analysis and bacterial functional parameters (microflora-associated characteristics).~   "
54233|NCT02857075|"~     Every year, several millions of red cell concentrates are transfused. For each of them, a~     pretransfusional compatibility test is performed. In France, an ABO compatibility test at the~     patient's bedside is performed, but rhesus compatibility is not yet checked. However, rhesus~     antigens are very immunogenic and could lead to Rh incompatibility or Rh disease.~      The objective of ABORDAGE project is to develop another biochip that specifically captures~     RBCs according the presence of the RH1 antigen (also known as D antigen) at their surface.~   "
54221|NCT02857244|"~     The study team proposes to treat Parkinson's patients with gait difficulty with~     multidisciplinary approach of medications. Single medication treatment, such as the use of~     cholinergic-boosting anti-dementia medication targeting cholinergic deficiency to improve~     executive dysfunction and attention deficit, or the use of medication boosting the~     norepinephrine system, have not proven effective so far in treating the gait difficulty.~     Anti-anxiety medications, particularly the SNRI (serotonin and norepinephrine reuptake~     inhibitor) medications, which also ameliorate the norepinephrinergic deficiency, have not~     been studied except for one successful case report using duloxetine to treat primary~     progressive freezing of gait.~      Targeting multiple mechanisms at same time, such as the combination of a SNRI antianxiety~     medication (also boosting the norepinephrine system, such as duloxetine) with an~     anti-dementia medication correcting the cholinergic deficiency (such as donepezil), or~     targeting a new mechanism, such as the use of anti-GABAergic medication targeting the area~     responsible for gait and sleep cycle (pedunculopontine nucleus area, PPNa) should be tried.~      Therefore, a collaboration of multidisciplinary teams among the neurology movement disorder~     team and cognition and sleep team, and psychiatry team is essential, which has not been tried~     before in studying and treating the challenging gait difficulty in Parkinson patients.~   "
54222|NCT02857231|"~     Comparison of changes in diastolic pulmonary artery pressure as measured by CardioMEMS™ to~     impedance parameters as measured by ImpediMed's BIS technology.~   "
54223|NCT02857218|"~     This pilot clinical trial studies how well ferumoxytol-enhanced magnetic resonance imaging~     (MRI) works in imaging lymph nodes in patients with stage IIB-IIIC esophageal cancer.~     Ferumoxytol is a form of very small iron particles that are taken up by cells in normal lymph~     nodes and may work better in imaging patients with esophageal cancer when paired with MRI.~   "
54224|NCT02857205|"~     Hirschsprung disease is a congenital abnormality due to the lack of migration of neural crest~     cells in myenteric and submucosal plexi of the bowel wall. The consequence is the absence of~     parasympathetic control of the distal bowel from the anal sphincter to various levels. The~     most common type of Hirschsprung disease alters the rectosigmoid (80%). The incidence is~     around 1/5000 live births. This anomaly requires a surgical ablation of the aganglionic~     segment.~      Regardless of the surgical complications, patients with Hirschsprung disease are exposed to~     the risk of Hirschsprung Associated EnteroColitis (HAEC). This variable risk, 4-54%, is~     responsible to a major part of Hirschsprung disease morbimortality. Its onset is more~     frequent during the first two years of life and then decrease with age.~      Its pathogenesis remains unclear but could be due to intestinal homeostasis breakdown that~     involves microbiota, intestinal barrier, immune system and enteric nervous system. This~     breakdown of the mutual benefit relation due to microbiota or bowel anomaly is known to be~     responsible of Crohn's disease onset. Some studies emphasize the role of microbiota in the~     pathogenesis of HAEC, but the techniques or the methodology with small numbers of patients~     limit any conclusion or clinical use.~      The study hypothesizes microbiota is a major factor in HAEC onset and in their functional~     bowel problems. Considering HAEC is more frequent the first two years, it's thought that~     intestinal microbiota changes with time in those patients. This project is innovative because~     it will use high throughput sequencing methods and analysis for microbiome analysis on fecal~     samples from a multicenter cohort of patients at various ages.~      Multicentre transversal study.~      This study has the potential to significantly modify clinical practice for Hirschsprung~     disease patients: a better care for HAEC and functional troubles thanks to a better~     understanding of their microbiota, targetted antibiotic treatment for HAEC, prophylactic~     treatment of patients at high risk of HAEC.~   "
54225|NCT02857192|"~     Giant cell arteritis (GCA) is the most frequent vascularitis after 50 years of age The~     investigators recently showed that GCA was accompanied by an elevation in Th1 and Th17~     response [1]. Even though a quantitative deficit in regulatory TL (Treg) was shown, there are~     to date no data concerning their precise phenotypic and functional characteristics and~     notably their ability to inhibit Th1 and Th17 polarisation. The hypothesis of the~     investigator is that, in GCA, there is quantitative and above all functional deficit of Treg.~     Recently, progress has been made in the identification of Treg with new markers (CD39), which~     will make it possible to better identify and to study their specific functions. In this study~     the phenotypic and functional characteristics of Treg in GCA will be analysed. Better~     understanding of the role des Treg in GCA should lead to better-targeted treatments for~     patients with GCA, notably via the blockage of cytokines that inhibit the differentiation~     and/or function of Treg.~      The study is classified interventional because a lot of blood samples are taken.~   "
54226|NCT02857179|"~     The aim of this cohort study is to collect prospectively clinical data on all the patients~     admitted in the investigators department for bariatric surgery or for any complication of a~     bariatric procedure. The investigators goal is not only to improve the follow-up but also to~     assess and publish the investigators results regarding weight loss and the complication rate.~   "
54227|NCT02857166|"~     The purpose of this study is to evaluate the safety, tolerance and Dose-Limiting Toxicity~     (DLT) of Recombinant humanized anti-PD-1 monoclonal antibody (JS001) in patients with~     advanced solid tumors.~   "
54228|NCT02857153|"~     This will be a multicentre, randomised, controlled and prospective clinical trial. All~     participants provided their written informed consent to participate in a randomized trial~     that examined the effects of low-level MAP (60-70 mmHg) vs. high-level MAP (90-100 mmHg) in~     elderly patients (65 or more years of age) during noncardiothoracic surgery under general~     anesthesia. The investigators hypothesise high-level blood presure of the intervention for~     reducing the incidence of post-operative complications.~   "
54229|NCT02857127|"~     A quasi experimental study evaluating the effectiveness of a walking program at primary~     health care settings in a low-income area~   "
54230|NCT02857114|"~     Measure the impact of touch relaxation on pain communicative patients suffering from chronic~     pain of cancer origin inpatient Oncology. measure over three days the effects on pain anxiety~     welfare and consumption of analgesics~   "
54231|NCT02857101|"~     The prognosis of spontaneous bacterial peritonitis (ISLA) remains a serious complication of~     cirrhosis. Rapid diagnosis of ISLA is a key issue for improving the prognosis. The~     determination of calprotectin in ascites, used for the diagnosis of infection of ascitic~     liquid, could allow the diagnosis in a very short time (about 30 minutes). To date, the~     determination of calprotectin in ascites was not evaluated properly. The investigators would~     thus evaluate the interest of the determination of calprotectin in ascites for the rapid~     diagnosis of ISLA in cirrhotic patients, like you, hospitalized for decompensation of their~     disease. The main purpose of this pilot study will determine the optimal threshold~     calprotectin in ascites for diagnosis of ISLA.~   "
54232|NCT02857088|"~     The study aimed to determine the emotional reactivity of depressed patients to visual and~     olfactory stimuli in comparison with healthy volunteers.~   "
77156|NCT02557087|"~     The aim of this study is to assess whether hyoscine butylbromide is as effective as pethidine~     for analgesia during the first stage of labor.~   "
54235|NCT02857049|"~     Malnutrition affects until 70% of the patients hospitalized in geriatric's units and~     constitutes an independent risk factor of morbidity and mortality. Malnutrition is also~     associated with increased length of stay and increased costs, and alters the quality of life.~     Oral nutritional supplements (ONS) play a key role in the prevention and treatment of~     malnutrition in older people. ONS are a simple way to offer in a small volume a nutritional~     supply with a high density of calorie and protein. The clinical efficiency of ONS is well~     demonstrated whether on nutritional parameters or on clinical outcomes. However,~     acceptability and consumption of these ONS are frequently suboptimal: in geriatrics, only 50%~     to 65% of the prescribed volumes of ONS are consumed. The reasons are multiple: anorexia,~     taste changes, monotony … also partly because patients dislike flavor, taste or texture. The~     respect of patients' preferences is essential to improve the therapeutic observance to ONS.~     Generally, ONS are delivered after the patient has told his preferences orally to the~     dietitian. To date, there is no study evaluating the effect of an alternative strategy based~     on a preliminary degustation of several products on the effective consumption of ONS in~     geriatrics.~      The study is designed as prospective, randomized, controlled, open study to test this~     strategy in older undernourished people hospitalized in geriatrics who require prescription~     of ONS. This study will be performed among 220 older people hospitalized in two departments~     of geriatrics of the AP-HM (Assistance Publique - Hôpitaux de Marseille).~      The main objective is to compare the therapeutic observance to ONS when products are~     delivered to older people according to the usual way (preferences announced orally and/or~     dietitian's choice) or according to an alternative strategy based on a preliminary~     degustation of several products varying for flavor and texture but always in respect of the~     medical prescription. The secondary objective is to compare the evolution of the nutritional~     status estimated by routinely used clinical and biological parameters, as well as the main~     clinical outcomes during the hospital stay. Lastly, the nutritional status of these patients~     will be reevaluated clinically 3 months after the hospital's discharge.~      The hypothesis is that a strategy based on a preliminary degustation, leading to an informed~     choice, will significantly improve the acceptability and the effective consumption of ONS~     during the hospital stay, and will also impact positively the nutritional status at~     hospital's discharge and 3 months after. The validation of this hypothesis could allow~     recommending the generalization of preliminary degustation of ONS at the time of their~     prescription to optimize the therapeutic observance in undernourished older people.~   "
54236|NCT02857036|"~     The study aims to characterize the rhythmic parameters of unipolar depressed patients that~     are associated with the response to antidepressants after 6 weeks of treatment.~   "
54237|NCT02857023|"~     Disease-related neurocognitive deficits are common in pediatric sickle cell disease (SCD).~     These deficits can significantly disrupt otherwise normal trajectories toward academic and~     vocational achievement and negatively impact psychosocial outcomes. Despite widespread~     recognition of neurocognitive deficits, there are no treatments shown to maintain or recover~     functioning once a child with SCD endures neuronal damage. Cognitive training (CT) has been a~     standard intervention used to stabilize and recover functioning in individuals with~     accidental or disease-related brain injury. Recent advances in technology have led to the~     development of computerized CT programs. This study seeks to assess the feasibility and~     efficacy of using computerized CT with pediatric patients with SCD. Children and adolescents~     with SCD between the ages of 7 and 16 years old (n = 80) will be recruited to complete a~     randomized (intervention or waitlist-control) home-based computerized CT program (Cogmed).~     Feasibility will be assessed by examining participation, retention, and program completion~     rates, as well as feedback from a feasibility and acceptability questionnaire and a brief~     qualitative interview. Participants will also complete assessments of attention, working~     memory, and academic fluency at baseline and immediately following the intervention. A final~     assessment will be conducted 6 months after the conclusion of the intervention to evaluate~     the stability of treatment effects.~   "
54238|NCT02857010|"~     Double-blind placebo randomized controlled trial evaluating the clinical efficacy of~     allogenic bone marrow derived mesenchymal stem cells in cirrhotic patients with~     acute-on-chronic liver failure~   "
54239|NCT02856997|"~     The purpose of this study is to evaluate the efficacy and safety of Chidamide with ICE~     regimen in patients with relapsed/refractory Peripheral T Cell lymphoma.~   "
54240|NCT02856984|"~     The overall objective of this multisite, multicountry Zika in Infants and Pregnancy (ZIP)~     study is to assess the strength of the association between Zika virus infection (ZIKV) during~     pregnancy and adverse maternal/fetal outcomes and the risk of vertical transmission. The~     study will prospectively enroll a cohort of pregnant women during the first trimester of~     pregnancy and follow them through their pregnancy to identify for clinical evidence of acute~     ZIKV, while controlling for potential confounders. Outcomes in the women, the developing~     fetus, and infants will be assessed. All protocol-specified data will be recorded and entered~     in a central data management system for the purposes of analysis of composite data from the~     study.~   "
54241|NCT02856971|"~     Between 2009 and January 2016, the investigators included 49 patients from four hospitals in~     Lyon who had a Total Knee Arthroplasty (TKA) infection and who benefited of a knee~     arthroplasty revision with a rotating hinge prosthesis. This retrospective and descriptive~     cohort aims at studying the functional results after 2 years follow up.~   "
54242|NCT02856958|"~     The purpose of this study is to compare acute nerve decompression versus nonoperative~     treatment in the management of peroneal nerve palsy after total knee arthroplasty (TKA). We~     hypothesize that acute nerve decompression patients will have better long-term outcomes to~     patients treated non-operatively for peroneal nerve palsies after TKA.~   "
54243|NCT02856945|"~     At this time, there is no standardization for knee trauma care in children. Each physician is~     free to resort or not to radiography to verify or dispel bone fracture, depending on~     radiographic device availability. This decision is based on trauma severity, clinical~     features, and physician experience.~      Knee traumatisms are a common reason of consultation. In emergency departments, radiographic~     use is widespread for those traumatisms, but not in private practice.~      Most of those knee traumatisms includes soft tissue lesion, for which radiography gives no~     details. Yet, radiography exposes bone fracture which may require a specific orthopaedic~     care. Then, it seems beneficial to highlight simple and reproducible clinical criteria in~     order to identify severe knee traumatisms, requiring radiography to assess bone fracture.~      Those criteria should have a sensibility close to 1, and the highest specificity. Such~     criteria could significantly decrease the number of radiography thus irradiation, emergencies~     waiting time, and consultation expenses without missing bone fracture.~      Ottawa knee rules for adults are: age 55 years older, tenderness at head of fibula, isolated~     tenderness of patella inability to flex to 90°, inability to bear weight on 4 steps both~     immediately and in the emergency department. Presence of one of those criteria required front~     and profile radiography to assess bone fracture.~      However, few studies have been conducted among children, and they do not confirm the use of~     those criteria targeting fracture screening. Data are contradictory and they do not allow~     concluding that such criteria could be of benefit for children. Moreover, studies only~     consider adults clinical criteria. This study would be the first to implement specific~     paediatric criteria, which make this study original.~   "
56953|NCT02821533|"~     The aim of the current study is to study the safety and effectiveness of TACE using a high~     dose of cisplatin for treatment of HCC. It is hypothesized that the formulation is safe and~     it improves the therapeutic effect of conventional TACE.~   "
54244|NCT02856932|"~     PICOTS:~      P: High Caries Risk Patients with bilateral class I cavities. I: Glass Ionomer with Glass~     Hybrid Technology. C: Conventional High Viscosity Glass Ionomer. O: Clinical performance~     (Functional properties Biological properties) using (World Dental Federation) Fédération~     dentaire internationale (FDI) criteria for dental restorations.~      T: 1 year. S: Randomized controlled Trial (split mouth design). Research question:In high~     caries risk patients with class I cavities will glass ionomer with glass hybrid technology~     has similar clinical performance as conventional high viscosity glass ionomer~   "
54245|NCT02856919|"~     This study evaluates the efficacy of Mirvaso® in the treatment of chronic persistent vascular~     facial erythema, after 4 weeks of treatment, by the Clinician erythema assessment.~   "
54246|NCT02856906|"~     The purpose of this study is to determine whether what kind of occlusion are related the~     orofacial pain under investigation, and whether occlusal adjustment have an effect in relief~     of this kind of orofacial pain.~   "
54247|NCT02856893|"~     The phase II APPLE trial gives the opportunity to prospectively validate liquid biopsies as a~     new standard for testing tumor progression compared with conventional radiological procedure~     in EGFR mutant advanced NSCLC patients. Moreover based on the sequential T790M test during~     treatment the investigators will assess the predictive value of liquid biopsies. APPLE trial~     will examine the best strategy for delivering osimertinib (upfront versus sequential~     treatment after 1st generation EGFR TKI) in EGFR mutant NSCLC patients. Finally, the trial~     will also explore the mechanisms of acquired resistance to Osimertinib based on the results~     of an optional biopsy upon progression.~   "
54248|NCT02856880|"~     The aim of this exploratory study is to assess the ability of two test toothpastes containing~     0.6% w/w zinc chloride stabilised with sodium citrate in a sodium lauryl sulfate~     (SLS)-containing base to reduce glycolytic metabolism and viability of de novo plaque~     bacteria using the plaque glycolysis regrowth model (PGRM).~   "
54249|NCT02856867|"~     This is a prospective, multicenter, randomized, placebo-controlled, triple-blind phase II~     trial. The randomization will be a 1:1 randomization (experimental arm:control arm). This~     study will enroll patients with histologically confirmed esophagogastric adenocarcinoma with~     metastatic disease. Patients will have had no previous chemotherapy for metastatic~     esophagogastric cancer. Patients will receive nintedanib or placebo in combination with~     mFOLFOX6 (5-Fluorouracil 400 mg/m2 bolus on day 1, 5-Fluorouracil 2400 mg/m2 continuous~     infusion over 46 hours starting on day 1, Leucovorin 400 mg/m2 on day 1, Oxaliplatin 85 mg/m2~     on day 1) via IV infusions every 2 weeks (14 days). Dose modification of nintedanib or~     placebo and mFOLFOX6 is allowed. Patients may continue to receive protocol therapy as long as~     they have not experienced any adverse events requiring permanent discontinuation of study~     medication and have not demonstrated disease progression.~      The primary objective is to test the hypothesis that progression free survival (PFS) is~     prolonged in HER2-negative patients with untreated metastatic esophagogastric adenocarcinoma~     when treated with nintedanib plus modified FOLFOX6 (mFOLFOX6) as compared to placebo plus~     mFOLFOX6. The analyses will be performed when 124 events for PFS will have been observed in~     the pooled arms.~   "
54250|NCT02856854|"~     EMB-001 is a combination of 2 drugs: the cortisol synthesis inhibitor, metyrapone~     (Metopirone®), and the benzodiazepine receptor agonist, oxazepam (original trade name Serax®;~     now marketed as oxazepam (generic) only).~      This Phase 1b cocaine interaction study is being conducted in order to assess the safety and~     PK of EMB-001 and cocaine in combination.~   "
54251|NCT02856841|"~     44 patients were enrolled in this study as they had malignant epithelial ovarian~     tumor.Pre-operative staging was assessed by CT scan based on FIGO classification and compared~     to the standard laparotomy surgical staging. Maximal surgical effort for Optimum~     cytoreduction was achieved and the risk factors for sub-optimal cytoreduction were studied~   "
54252|NCT02856828|"~     The purpose of this study is to evaluate the effectiveness of a novel digital image~     enhancement (DIE) technology in reducing the radiation exposure to both the patient and~     surgical staff during standard intramedullary nail placement for treatment of hip fractures.~     Secondarily, to evaluate whether the image quality and reproducibility of desired images can~     be improved with use of the DIE technology. Finally, to evaluate whether DIE technology~     reduces total operative time.~   "
54253|NCT02856815|"~     To evaluate the efficacy and safety of 'Immuncell-LC group' and 'non-treatment group' in the~     patients undergone Transarterial Chemoembolization for intermediate stage hepatocellular~     carcinoma~   "
54254|NCT02856802|"~     A safety and efficacy of DFN-02, being conducted at multiple centers in the United States.~   "
54255|NCT02856789|"~     The purpose of the study is to give the proof of concept of the Fibrin structure assay on~     STA-R® prototype. It aims to identify the parameters which discriminate the pathologic from~     the normal population. Secondary objectives are to determine the precision of the assay, to~     record the Fibrin activity, comparatively with thromboelastography on TEG®, in a coagulation~     activation assay and in a coagulation-lysis assay.~   "
54256|NCT02856776|"~     There continues to be debate as to how much vitamin D an adult requires to be vitamin D~     sufficient. A multitude of association studies have suggested that improving serum 25(OH)D~     >30 ng/mL may reduce risk of many chronic illnesses and improve immune function. The aim of~     this study is to define dynamic changes in PTH, broad gene expression in circulating immune~     cells, metabolomics, and microbiome profile in response to varying doses of vitamin D~     supplementation.~   "
54257|NCT02856763|"~     To identify predictive factors of adalimumab (anti TNF) response in patients with luminal~     Crohn's disease complicated by intra-abdominal and/or pelvic abscess after complete~     resolution of infection.~   "
54258|NCT02856750|"~     A Multi-center, Randomized Controlled Trial of the Efficacy of Gabapentin vs. Placebo for~     Adjutant Pain Control Following Acute Rib Fractures.~   "
54304|NCT02856139|"~     PURPOSE: To characterize the appearance of the far peripheral retina of normal eyes using~     ultra-widefield fluorescein angiography (UWFA).~      DESIGN: Prospective observational case series. METHODS: This study enrolled normal eyes with~     best corrected visual acuity ≥ 20/20, refractive error < 3.00D, and without visible retinal~     pathologic changes under a slit lamp-based condensing lens. The far peripheral retina was~     detected by UWFA. Ciliary body thickness (CBT) at 3 mm (CBT1) and 2 mm (CBT2) posterior to~     the scleral spur was measured by ultrasound biomicroscopy.~   "
54259|NCT02856737|"~     Delirium is an acute disturbance in mental abilities and confusion that affects many patient~     in the hospital and is caused by multiple factors including and altered sleep/wake cycles and~     multiple sedating medications. Patients in the ICU are particularly susceptible to developing~     delirium due to increased noise levels and metabolic derangements.~      Numerous studies have shown that delirium can be associated with many negative outcomes,~     including longer hospital length of stay, increased time on a ventilator, higher mortality~     rates, and greater long-term cognitive dysfunction. There are a series of non-pharmacological~     interventions that have been shown to reduce delirium especially in intensive care units.~     These include noise reduction, frequent reorientation, reducing unnecessary stimulation at~     night, and grouping patient care procedures.~      The aim of this study is to evaluate the benefits of eye masks and earplugs (used~     concurrently) on reducing delirium and to assess for associated outcomes such as length of~     stay, use of sedating medications, morbidity, and mortality. The benefits of this are to~     improve sleep quality, and this intervention has been associated with a reduction in the risk~     of delirium.~   "
54260|NCT02856724|"~     This study evaluates the effectiveness and safety of early amniotomy after vaginal~     prostaglandin E2 for induction of labor at term. Early amniotomy will be done in the early~     active phase of labor for early amniotomy group ( half of participants) when the cervix will~     dilated 3 cm using the amniotomy hook. Amniotomy will not be done for control group(other~     half of participants) until the membranes rupture spontaneously.~   "
54261|NCT02856711|"~     The investigators propose to evaluate how the CenteringPregnancy curriculum compared with an~     enhanced curriculum, with the addition of 2 trauma-informed interventions, affects how new~     parents prepare for parenting and respond to common stressors.~   "
54262|NCT02856698|"~     Acute pulmonary edema (APE) is a common condition in the emergency room, associated with~     considerable mortality. The use of intravenous morphine in the treatment of APE remains~     controversial and Benzodiazepines have been suggested as an alternative for morphine to~     relieving dyspnoea and anxiety in the patients with APE. The MIdazolan versus MOrphine in APE~     trial (MIMO) is a multicenter, prospective, open-label, randomized study designed to evaluate~     the efficacy and safety of morphine in patients with APE.~   "
54263|NCT02856685|"~     This is a Phase 1/2, open-label, multicenter study.~   "
54264|NCT02856672|"~     The investigators study compared the Laryngeal Tube Suction-Disposable with the Supreme~     Laryngeal Mask Airway, hypothesizing that the two devices would provide adequate~     oropharyngeal seal pressure in different head and neck positions and perform similarly during~     pressure controlled ventilation in neutral position, despite differences in their structural~     design.~   "
54265|NCT02856659|"~     Study of freedom sound processor users that upgrade to N6 sound processor CP900 series. To~     test speech understanding in each device and usability of upgrade.~   "
54266|NCT02856646|"~     The purpose of this study is to gather data on patients diagnosed with and treated for~     classical Hodgkin Lymphoma (cHL). It aims to closely observe how treatment for cHL is~     rendered, as well as assess the outcome of those treatment options and their impact on~     quality of life. Additional analyses will also attempt to identify prognostic or predictive~     biomarkers~   "
54267|NCT02856633|"~     The study objective is to satisfy the testing requirements for the Qualcomm Tricorder XPRIZE~     Competition. This requires an oversight model using the Vitaliti CVSM Wearable, Vitaliti~     Spirotoscope, and Vitaliti IVD Station to continuously monitor the patient's five core vital~     signs and to detect the health conditions required by the competition.~   "
54268|NCT02856620|"~     The role of cardiac mechanics, circulating biomarkers and frailty in predicting outcomes in~     patients with aortic stenosis after aortic valve replacement (SCRABLES -The 2-Parts Study)~     Part I: Observational study to characterize phenotypes, structural alterations and biomarkers~     profiles in a broad spectrum of patients with aortic stenosis and heart failure with~     preserved ejection fraction (HFpEF).~      Part II: Prospective cohort study to characterize patients' phenotypes, cardiac structural~     alterations, circulating biomarkers and frailty in order to optimize risk stratification and~     patient selection for aortic valve intervention.~   "
54269|NCT02856607|"~     Infective endocarditis (IE) is defined as a bacterial infection of the endocardium (inner~     surface of the heart), which may include one or more heart valves. Epidemiologic pattern has~     changed during the last 20 years whereas the incidence was unchanged. However, the mortality~     increase despite recent diagnosis and therapeutic advances.~      Only few investigations consider the prognostic and the therapeutic medical care according to~     the clinical care pathway. In fact, 3 situations are observed: (i) patient for whom diagnosis~     and medical care are realized in a referent center with cardiac surgery, (ii) patients~     secondary addressed to a referent center with cardiac surgery, (iii) patients for which the~     totality medical care are performed in non-referent health center. In addition, epidemiologic~     studies concern only a part of IE, not including most of the time the patients hospitalized~     in non-referent center.~      The aim of the study was to determine the prognosis of threated patients according to the~     clinical care pathway. Secondary objectives was (i) to evaluate the application of European~     recommendations concerning trans-oesophageal echocardiogram (TOE), antibiotic treatment and~     surgical practice, (ii) to compare the epidemiologic profile according to the type of center.~      For this, 300 patients addressed in the 22 French participating centers for a possible or~     certain IE according to Duke Criteria were prospectively included during 3 years.~      Patient data (clinical, demographical, biological, microbiological, echocardiographic and~     evolutive data) were collected at the admission, during hospitalization, at discharge and~     one-year follow up.~   "
54270|NCT02856594|"~     This study aims to determine whether, compared with placebo, the nighttime administration of~     a intravenous dexmedetomidine is effective at inducing sleep and preventing postoperative~     delirium in extubated post-cardiac surgical patients.~   "
54305|NCT02856126|"~     The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion~     chemotherapy (HAIC) compared with transarterial chemoembolization (TACE) in patients with~     BCLC stage hepatocellular carcinoma (HCC).~   "
54306|NCT02856113|"~     This study will evaluate the efficacy and safety of alogliptin 25 mg once daily (QD) compared~     to placebo when administered as monotherapy, or when added onto a background of metformin~     alone, insulin alone, or a combination of metformin and insulin in pediatric participants 10~     to 17 years of age with type 2 diabetes mellitus (T2DM).~   "
54271|NCT02856581|"~     This randomized phase III trial studies how well management of a tobacco treatment~     intervention works in reducing surgical complications in patients with newly diagnosed lung~     cancer who smoke cigarettes. Management of a tobacco treatment intervention compares~     varenicline (a drug that reduces the craving and withdrawal symptoms that occur with~     abstinence from nicotine) and behavioral interventions (consisting of a brief~     clinician-delivered intervention and tobacco quitline [tobacco cessation service available~     through a toll-free telephone number] follow-up) with placebo (a pill with no active~     medication) along with similar behavioral interventions. It is not yet known whether~     management of a tobacco treatment intervention is more effective in reducing surgical~     complications than placebo.~   "
54272|NCT02856568|"~     This phase Ib trial studies the side effects and best dose of ricolinostat when given~     together with gemcitabine hydrochloride and cisplatin in treating patients with~     cholangiocarcinoma that cannot be removed by surgery or has spread to other places in the~     body. Ricolinostat may stop the growth of cancer cells by blocking some of the enzymes needed~     for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin,~     work in different ways to stop the growth of tumor cells, either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading. Giving ricolinostat together~     with gemcitabine hydrochloride and cisplatin may work better in treating patients with~     cholangiocarcinoma that cannot be removed by surgery or has spread to other places.~   "
54273|NCT02856555|"~     The primary objective of this study is to evaluate the safety and tolerability of GS-0976 in~     adults with nonalcoholic steatohepatitis (NASH).~   "
54274|NCT02856542|"~     This study aims to describe the patient population being treated and evaluate their treatment~     adherence and treatment outcomes during treatment of scalp psoriasis with Daivobet® gel~     Applicator for 4 weeks.~   "
54275|NCT02856529|"~     Considering the importance of infection control practices, Madinah Public Health Department~     launched a new license program for healthcare workers, the Basic Infection Control Skills~     License program (BICSL). BICSL has been launched to train healthcare workers all over the~     region in a scientific standardized way.~      To assess BICSL effectiveness, a non-randomized control study will be conducted in two of the~     general hospitals in Madinah. An electronic bilingual self-administrated valid and reliable~     questionnaire will be used to evaluate the workers knowledge and practices before and after~     three and six months of the intervention. The knowledge and practice answers were scored and~     the scores were categorized to facilitate the comparison. A BICSL certified trainer will be~     conducting the intervention, a one to one training session. A SPSS program will be used to~     analyze the data. Administrative and ethical approval was obtained from Madinah health~     authority. The participants will complete an electronic consent before they fill the~     questionnaire. Confidentiality and privacy as well as freedom to participate or not will be~     insured to all participants. This study will assess the license effectiveness in improve~     knowledge and compliance.~   "
54276|NCT02856516|"~     This will be a randomized, cross-over design. Subjects will be randomized to one of three~     interventions on three separate study days, 1 week apart.~   "
54277|NCT02856503|"~     High-doses of Vitamin D (VD) may be used as targeted therapy against breast cancer. The~     investigators will assess the effect of high dose VD on the following biomarkers in the~     breast cancer cells: VDR, estrogen receptor (ER), progesterone receptor (PR), epidermal~     growth factor receptor 2 (Her2/neu), androgen receptor (AR), as well as epidermal growth~     factor receptor 1 (EGFR) and Ki-67, as markers of proliferation, and E-cadherin, a marker of~     invasion and metastasis.~   "
54278|NCT02856477|"~     The study aims to assess the therapeutic benefits of the adaptation of the antidepressant~     dose to the metabolic capacity (cytochrome P450 2D6) of elderly depressed patients.~      Therapeutic benefits are evaluated through the enhancement of efficiency, decrease of the~     action time and the after effects.~   "
54279|NCT02856464|"~     The trial will be conducted as a multicentre open label, randomised prospective phase II~     clinical trial in patients with high risk myeloid malignancies.~      The primary objective is to evaluate whether prophylactic donor lymphocyte infusions (DLI)~     delivered as part of a planned schedule improves the disease free survival of patients with~     myeloid malignancies.~   "
54280|NCT02856451|"~     A case series analysis of encephalitis events reported to the Sponsor for patients treated~     with nivolumab to assess the risk factors and outcomes of immune-mediated encephalitis.~   "
54281|NCT02856438|"~     The objective of this expanded access program is to provide treatment with elotuzumab in~     combination with lenalidomide and dexamethasone for patients with relapsed or refractory~     multiple myeloma at Japanese sites where licensed physicians determine clinical need.~   "
54282|NCT02856425|"~     Both anti-angiogenesis and anti PD1 immunotherapy have shown beneficial efficacy in solid~     tumors and in particular in NSCLC. Therefore it is of interest to investigate whether the~     combination of these two approaches is tolerable. Moreover, comprehensive pre-clinical and~     clinical rationale sustain the hypothesis that anti-VEGF could synergize with immunotherapy~     for the benefit of the patients.~   "
54283|NCT02856412|"~     There is evidence demonstrating that aerobic exercise improves many symptoms of Posttraumatic~     Stress Disorder (PTSD) including; anxiety, depression, insomnia, and cognition. With the goal~     of using exercise as a rehabilitation therapy for Veterans with PTSD, a team of scientists~     and doctors developed a 12-week exercise program, combining aerobic and strength training~     with concentration training and mindful breathing techniques. The initial pilot study~     suggested that Integrative Exercise may improve overall quality of life, sleep quality,~     cardiovascular fitness, and PTSD symptoms. This new study will help determine the~     effectiveness of Integrative Exercise compared to health education classes. The overall goal~     is to determine if integrative exercise is an effective rehabilitation intervention for~     combat Veterans with PTSD.~   "
54284|NCT02856399|"~     The methadone is an useful opioid for the cancer pain treatment, mostly used in second or~     last line during the opioid rotation. The Methadone had an anti-MNDA effect, and clinicians~     agree that the methadone could have an effect in neuropathic cancer pain. During a previous~     study the investigators find that the pain was still improving after the week 2, but they had~     only a small number of patients still included at this stage and they cannot conclude.~      The investigators decide to follow up systematically all the patients undergoing a methadone~     treatment for cancer pain, at day 28, to study the hypothesis about the long-term pain~     improvement.~   "
54286|NCT02856373|"~     Rationale:~      Sympathetic activity plays an important role in the pathogenesis of ventricular~     tachyarrhythmia. Previous studies have shown evidence of significant heritable influences on~     individual responses to adrenergic stimulation. Catheter-based renal sympathetic denervation~     (RDN) is a novel treatment option for patients with resistant hypertension, proved to reduce~     local and whole-body sympathetic activity. The investigators hypothesize that percutaneous~     transluminal electrical stimulation of the sympathetic nerve bundles in the renal arteries~     will cause ventricular arrhythmias and renal denervation will suppress these arrhythmias in~     patients with sympathetic ventricular arrhythmias.~      Objective:~      This study will investigate the effects of renal nerve stimulation before and after~     percutaneous transluminal RDN on cardiac excitable properties including induction of~     ventricular tachy-arrhythmias before and after RDN in six studies, i.e. patients with~     catecholaminergic polymorphic ventricular tachycardia (CPVT), long QT syndrome and~     arrhythmogenic right ventricular cardiomyopathy (ARVC), sympathetically driven ventricular~     arrhythmias, hypertrophic cardiomyopathy (HCM), dilated non-ischemic cardiomyopathy (DCM) and~     ischemic cardiomyopathy (ICM). The aim of the six studies is to assess the anti-arrhythmic~     effects of RDN in patients with sympathetic ventricular tachy-arrhythmias.~      Study design:~      Investigator initiated, multi centre, six pretest-posttest design studies.~      Study population:~      Patients with recurrent sympathetically driven ventricular arrhythmia despite optimal~     pharmacological therapy. Patients should be diagnosed with CPVT and certain types of long QT~     syndrome, ARVC, HCM, DCM and ICM. Eligible patients will be in the age category of 18-85~     year.~      Intervention:~      RDN will be performed according to routine clinical practice. Prior to the ablation~     procedure, catheter mapping of the renal arteries will be performed according to routine~     clinical practice. Clinical and biological responses to transluminal electrical renal nerve~     stimulation will be assessed before and after RDN.~      Study endpoints:~        -  Main procedural study endpoint: Induction of ventricular arrhythmias in response to~          renal nerve stimulation prior to RDN and absence of renal nerves stimulation induced~          ventricular arrhythmias after RDN.~        -  Main clinical study endpoint: Development of ventricular arrhythmia during exercise~          stress testing performed 6 months after procedure.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness:~      In several studies, it was shown that RDN was safe. The intervention resulted in~     significantly better control of blood pressure with less medication, and beneficial changes~     in heart rate variability, autonomic sympathetic balance, renal arteriolar function, and a~     higher success of atrial fibrillation prevention. In case reports and case series, RDN had a~     favourable effect in patients with sympathetic drug refractory ventricular tachy-arrhythmias.~   "
54287|NCT02856360|"~     The objective of this proposal is to determine the effects of footwear stiffness on a large~     cohort of high school football players during a football season. The investigators expect~     that functional athlete groups will be developed, based on subject specific assessments~     (biomechanical, morphological, performance, comfort), and lead to important translational~     findings that may impact footwear modification and recommendation to a population of American~     football players. Two standard cleats will be randomized and provided during a season of high~     school football. Ratings of comfort, performance, and injury will be collected throughout the~     season.~   "
54288|NCT02856347|"~     The aim of the trial is to study a radiating diagnosis agent used in post surgery when the~     biological assessment highlighted a residual disease.~      This is an inter-regional multicentric, prospective study evaluating the benefit of PET~     F-DOPA imaging in involved node detection compared to standard imaging assessment in patient~     with medullary thyroid cancer.~      The purpose of the study is to evaluate the impact and performance of a new PET / CT~     (computerized tomography ) tracer targeting dopamine receptor in patient with residual~     ganglionar biological disease after initial surgery of medullary thyroid cancer compared to~     standard imaging.~      Obtained data will be compared to the gold standard based on :~        -  nodes cytology when they could be punctured~        -  histology when a new surgery will be recommended~        -  surveillance when the 2 first cases will be not applicable (imaging monitoring,~          evolution of thyrocalcitonin)~   "
54289|NCT02856334|"~     The purpose of this study is to determine if the psychosocial factors in women with chronic~     pelvic pain are predisposing, precipitant or maintenance factors, and relate these factors~     with central sensitization and dysfunctional pain.~   "
54290|NCT02856321|"~     A recent publication (Boulay et al. 2012) highlighted the role of the peroneus longus (PL)~     muscle in equinus foot deformity in children with hemiplegia. BoNT (Dysport) injections into~     this muscle have not yet been described in the literature. Based on the results of a previous~     study, the hypothesis is: this muscle may thus constitute a new therapeutic target for~     botulinum toxin injections in the early management of spastic equinus in children aged 2~     years or older, before the onset of fixed neuro-orthopedic deformity and the midfoot break.~      The aim of this retrospective study is to describe in intramuscular BoNT (Dysport) injections~     into PL based on the results obtained in a cohort of children (approximately 30 subjects)~     with cerebral palsy (hemiplegia or diplegia) and which have been treated in the service since~     2007 until July 2012.~      The investigators results are based on clinical, radiological and video evaluations. For this~     study, data will be collected in medical folder of each children belonging to this cohort.~      All children (approximately 30 subjects) with cerebral palsy (hemiplegia or diplegia) which~     have been treated by BoNT (Dysport) intramuscular injections into PL in the service between~     2007 and July 2012 will be screened. Subjects will be selected according to the following~     defined inclusion and exclusion criteria.~      Data will be collected retrospectively (using a specific case report form designed for the~     study) in medical folder of each included subject for all visit of follow-up after BoNT~     (Dysport) injection into PL (since the first BoNT (Dysport) injection up to 2012). Then, data~     will be entered in a database. After that, they will be analysed .~   "
54291|NCT02856308|"~     This is a prospective, single-arm, multi-center, international, open-label, non-randomized,~     clinical study.~      The aim of the study is to assess the safety and efficacy of the use of the Hairstetics hair~     implant device in subjects affected with hair loss.~   "
54292|NCT02856295|"~     The aim of this study is to compare between anti-10a levels in postpartum women receiving~     different prophylactic doses of LMWH: one group with LMWH doses adjusted by the women's~     weight and the second group receiving 1mg/kg to a maximum dose of 120 mg~   "
54293|NCT02856282|"~     The purpose is to obtain real-world information on how consumers are complying with the~     product labelling This study will coincide with the launch of Pirinase Hayfever Relief for~     Adults 0.05% Nasal Spray in the United Kingdom (UK).~   "
54294|NCT02856269|"~     The purpose of this pilot study is to determine whether zinc supplementation significantly~     affects immune activation in HIV-infected subjects.~   "
54307|NCT02856100|"~     We intend to validate 18F-DCFPyL for imaging patients with metastatic, castrate-resistant PCa~     (CRPC), so that it may be used to full advantage in supporting existing and emerging~     therapies for a spectrum of patients suffering from PCa. In this study we will image patients~     with CRPC undergoing second-line anti-androgen therapy (enzalutamide or abiraterone) using~     18F-DCFPyL-PET/CT for detection of metastases and therapeutic monitoring, with correlation to~     standard-of-care conventional imaging modalities (CIM) (CT, bone scan) and clinical~     follow-up.~   "
54308|NCT02856087|"~     High-dose remifentanil infused intraoperative ironically results in postoperative~     hyperalgesia. Ultra-low dose nalxone is demonstrated to prevent these opioid-induced~     hyperalgesia in animal model. In this clinical trial in patients undergoing general~     anesthesia with remifentanil, we evaluate the effects of ultra-low-dose naloxone on~     remifentanil-induced hyperalgesia~   "
54295|NCT02856256|"~     The choroid is a richly vascularized conjunctive tissue, providing the nutritive elements to~     the pigmentary epithelium and the photoreceptors of the retina. It drains 80% of the eye's~     blood. The choroidal thickness fluctuates according to the state of fullness of its~     constitutive vessels. The choroid and the neuroretina (separate by the pigmentary epithelium)~     are intimately linked and are subject to modifications during the ingestion of caffeine and~     taurine combined. Several authors have shown a significant decrease of the choroidal~     thickness lasting at least 4 hours after the ingestion of a small coffee. This decrease may~     be caused by caffeine's vasoconstrictor effect. Taurine is the most abundant amino acid in~     the retina. Recent studies have shown the importance of this amino acid in the physiology of~     both, retinal pigmentary epithelium and retinal ganglion cells.~      RedBull® is an energizing drink, where one single 25 cl can contains 80 mg of caffeine (the~     equivalent of a coffee mug) and 1 g of taurine.~      This pilot trial aims to study the variations of the choroidal thickness and to describe~     possible modifications within the pigmentary epithelium, due to the ingestion of caffeine and~     taurine. The results of this study will act as a reference for an ulterior trial aiming~     specific choroidal pathologies of young patients, such as the central serous chorioretinitis.~   "
54296|NCT02856243|"~     Cryoglobulinemia are responsible for systemic vasculitis, and the most frequently targeted~     organs are the skin, joints, kidney and peripheral nervous system. Cryoglobulinemia~     vasculitides are associated with significant morbidity and mortality, and require therapeutic~     intervention. With the discovery of hepatitis C virus (HCV) as the etiologic agent for most~     cases of mixed cryoglobulinemia new opportunities and problems for crafting therapy of HCV~     mixed cryoglobulinemia (MC) have emerged. A new and major concern was the potential adverse~     effects that immunosuppressive therapy with glucocorticoids and cytotoxic drugs could have on~     an underlying chronic viral infection. Alternatively the discovery of HCV provided the~     opportunity to control HCV-MC with antiviral therapy based on the belief that the underlying~     infection was driving immune complex formation and resultant vasculitis. Inducing a sustained~     virologic and clinical response and minimizing the use of immunosuppressive drugs are the~     main goals in the treatment of patients with HCV-MC vasculitis. Aggressive antiviral therapy~     has been shown to induce a complete remission of HCV-MC in up to 70% of patients. New~     antiviral combination, Interferon (IFN)-free regimens have recently proved very high~     virological response rate and with a very good safety profile and now need to be evaluated in~     severe and/or refractory HCV-MC patient's population.~   "
54297|NCT02856230|"~     Endovascular treatment of below the knee disease is a well-established therapy to improve~     outcomes in patients with critical limb ischemia. Several large cohort studies demonstrated~     the safety and the efficacy of percutaneous recanalization and angioplasty for distal vessel~     disease. A successful recanalization of foot artery was related to a higher ulcer healing and~     a reduction of major amputation. Moreover absence of revascularization in a patient with~     critical limb ischemia is an independent risk factor for mortality. Despite the introduction~     of new devices dedicated to below the knee vessel disease treatment, with the development of~     guides and conical balloons, long term patency outcomes are still poor. Restenosis was~     observed in more than two thirds of patients within 3 months after angioplasty of tibial~     arteries with a high target lesions revascularization. These re-interventions are~     characterized by a higher morbidity and mortality due to several comorbidities associated to~     these patients. These data confirm the need to obtain more lasting results in order to~     improve long-term outcomes of these patients.~      Recently, the use of drug-eluting balloons (DEB) has revealed an increase in patency after~     angioplasty of the femoral artery. On the contrary, results for BTK arteries angioplasty have~     shown controversial results.~      The purpose of this study is to evaluate the safety and the efficacy of the Ranger™ SL~     paclitaxel coated balloon a model of drug eluting balloon in patients with critical limb~     ischemia.~   "
54298|NCT02856217|"~     Pelvic organ prolapse occurs when the uterus or vaginal walls bulge into or beyond the~     vaginal introitus. Abdominal sacrocolpopexy is the most durable operation for advanced pelvic~     organ prolapse and serves as the criterion standard against which other operations are~     compared. Abdominal sacrocolpopexy involves attaching the vaginal apex to the sacral anterior~     longitudinal ligament reinforced with a graft, usually synthetic mesh. More than 225.000~     surgeries are performed annually in the United States for pelvic organ prolapse. Abdominal~     sacrocolpopexy is considered the most durable pelvic organ prolapse surgery, but little is~     known about safety and long-term effectiveness.~      Purpose of this study is to compare effect of tunneling or non-tunneling mesh placement on~     lower urinary tract symptoms and bowel symptoms in patients who underwent surgery with~     laparoscopic or robot-assisted sacrocolpopexy which is accepted surgical procedures for~     pelvic organ prolapse.~   "
54299|NCT02856204|"~     This research trial studies the shotgun sequencing of blood samples in diagnosing febrile~     neutropenia in patients with acute myeloid leukemia. Studying samples of blood from patients~     with acute myeloid leukemia in the laboratory may help identify pathogens and accurately~     diagnose infections such as febrile neutropenia.~   "
54300|NCT02856191|"~     The aim of this pilot study is to determine, as exhaustively as possible thanks to the~     continuous and precise recording of heart rhythm, the frequency of de novo atrial~     fibrillation in septic shock, which is currently unknown, and to identify specific factors~     that could be associated with the condition. These will be investigated more precisely in a~     future study. This constitutes the first step in a reflection on the management of Cardiac~     Arrhythmia by Atrial fibrillation (ACFA) in septic shock in Medical Intensive Care, known as~     a major prognostic factor for morbimortality, but for which management is uncertain in the~     absence of reference data.~   "
54301|NCT02856178|"~     This study assesses the pharmacokinetics and safety of the new antifungal F901318 in AML~     patients.~   "
54302|NCT02856165|"~     Over the last decade, high-flow nasal oxygen therapy (HFN) has emerged as a new method to~     provide respiratory support in children with moderate to severe bronchiolitis.~      However, any randomized clinical trial (RCT) have demonstrated that earlier support with HFN~     is superior to standard care including low -flow nasal oxygen therapy to reduce the risk of~     acute respiratory failure requiring non invasive (or tracheal) ventilation and subsequently~     the need of PICU transfer.~   "
54303|NCT02856152|"~     This open-label, randomized, 4-way crossover study in healthy participants will determine the~     relative bioavailability of the tablet formulation relative to the capsule formulation and~     the effect of a high-fat and low-fat meal on the relative bioavailability of the tablet~     formulation.~   "
54309|NCT02856074|"~     The current management of ischemic stroke is based on different strategies that may be~     combined: intravenous thrombolysis in a stroke ICU, intravenous thrombolysis in a~     telemedicine procedure, endovascular thrombectomy. Given this now rich therapeutic arsenal,~     it seems necessary to evaluate practices in local care in the field and the impact of these~     on the prognosis of ischemic stroke victims. The aim of this observational study is to~     compare these different care practices without interfering with the choice of strategy.~      A blood sample will also be taken at different times to study the value of growth~     differentiation factors (GDF) 8, 11 and 15, and Brain-derived Neurotrophic Factor as~     prognostic biomarkers~   "
54310|NCT02856061|"~     This pilot study examines concurrent and predictive relationships between eye tracking and~     clinical outcomes during a 16-week behavioral intervention (PRT) for children with ASD. Eye~     tracking will be comprised of both laboratory-based measures (using a commercial eye-tracking~     system) as well as home-based measures (using tablet-based eye tracking systems). The major~     goals of this study are both to improve our understanding of the potential role of eye~     tracking in clinical trials and to advance technologies that may further improve the~     sensitivity, robustness, accessibility, and ultimate utility of eye tracking methodologies.~   "
54311|NCT02856048|"~     The purpose of this study is to determine the efficacy of a temporary ovarian suppression~     obtained by administration of a gonadotropin releasing hormone agonist during alkylating~     agents containing chemotherapy on ovarian reserve assessed by Anti-Müllerian hormone (AMH)~     serum levels in adolescents and young women with cancer.~   "
54312|NCT02856035|"~     Stroke (795,000/year in the US and 30 million existing stroke survivors in the world) damages~     brain neural structures that control coordinated upper limb movement. To most effectively~     target the brain damage, interventions should be directed so as to restore brain control~     serving coordination of peripheral neuromuscular function. Currently, there is a lack of a~     transformative intervention strategy, and only limited efficacy is seen in response to neural~     rehabilitation that is only peripherally-directed (limbs e.g.) or only directed at the brain.~     This study will employ a novel neural feedback approach with a closed-loop, real-time~     paradigm to engage and retrain existing brain function after stroke. Real-time functional~     magnetic resonance imaging (rtfMIR) provides neural feedback with the advantage of precisely~     identifying the location of brain activity for multiple cognitive and emotional tasks.~     However, the rtfMRI is costly and precludes motor learning that requires sitting and engaging~     the upper limb in complex motor tasks during imaging acquisition. In contrast, real-time~     functional near-infrared spectroscopy (rtfNIRS), although not as spatially precise as rtfMRI,~     offers a low-cost, portable solution to provide brain neural feedback during motor learning.~     This proposal will utilize both technologies in a hybrid, sequential motor learning protocol.~     Moreover, the study protocol will also simultaneously involve both central effective signals~     (through neural feedback) and peripheral affective signals by employing neutrally-triggered~     functional electrical stimulation (FES)-assisted coordination practice, which produces~     peripherally-induced affective signals from muscle and joint receptors. This novel~     combination intervention protocol will engage the central nervous system, motor effective~     pathway training along with induction of affective signal production (FES-assisted practice),~     all of which will be implemented within the framework of evidence-based motor learning~     principles.~   "
54313|NCT02856022|"~     The purpose of this study is to determine whether electrical ilioinguinal nerve stimulation~     (EINS) is more effective than intravesical irrigation (II) in treating bladder pain syndrome.~   "
54314|NCT02856009|"~     Stroke in elderly subjects has a more severe clinical presentation (in terms of frequency of~     aphasia, hemiplegia or consciousness disorders), and a worse functional and vital prognosis.~     Patients older than 75 years also show excess mortality. One of the hypotheses to explain~     this situation is the high level of frailty in this population. Many tools to measure the~     concept of frailty have been developed. One important dimension of these tools is the~     nutritional status. Indeed, protein-energy malnutrition in the elderly, though a frequent~     situation, is also a complex phenomenon.~      The aim of this study is therefore to analyse the impact of protein-energy malnutrition, as a~     marker of frailty, on the early prognosis (at 28 days) in the aftermath of stroke in subjects~     older than 75 years hospitalized in Dijon CHU.~   "
54315|NCT02855996|"~     The Child and Family Research Partnership (CFRP) will be conducting the local evaluation of~     AVANCE's Fathers in Action/Padres Activos (FA/PA) fatherhood program. AVANCE is a non-profit~     organization that has served low-income families and children since its founding in 1973.~     AVANCE sites have been providing fatherhood services for some time, but the programming~     offered has varied across sites and no rigorous evaluation of the programs has been~     completed. Through a federally-funded Responsible Fatherhood grant, AVANCE aims to create one~     fatherhood curriculum to be used across their sites: Fathers in Action/Padres Activos~     (FA/PA).~      The purpose of the study is to advance the field of knowledge in the area of fatherhood~     programing by providing rigorous evidence on the impact of a comprehensive fatherhood program~     on enhancing a father's ability to be involved with and parent his child, in addition to~     providing more information on the selective characteristics of fathers who choose to~     participate in fatherhood programs. The study will seek to answer the following research~     questions: (1) What are the demographic and relationship characteristics of fathers who~     choose to participate in the Fathers in Action/Padres Actívos (FA/PA) program, and how do~     these characteristics compare to the fathers associated with mothers and children in other~     AVANCE programs?; (2) Does the FA/PA program positively impact parenting and co-parenting,~     father engagement and involvement, and healthy relationship?; (3) Are the program impacts~     similar for low-income fathers across regions (Houston v. the Rio Grande Valley),~     race/ethnicity (African American v. Hispanic), and coresidential status (nonresident v.~     resident)?; and (4) What are the factors that enhance or impede the successful implementation~     of the FA/PA program?~   "
54316|NCT02855983|"~     The specific aim of this study is to determine whether perforating fat injections to the~     plantar fascia is a safe method to improve pain, quality of life, and reduce plantar fascia~     thickness for patients with chronic plantar fasciitis. We will also correlate the intrinsic~     fat properties of adipose stem cells (ie. growth factors) to the improvement in pain, quality~     of life, and plantar fascia thickness over time.~   "
54349|NCT02855554|"~     The overall goal of this project is to evaluate the clinical potential of fast quantitative~     myocardial tissue characterization using recently emerged Cardiac Magnetic Resonance Imaging~     (CMR) techniques to aid the diagnosis, treatment, and follow up of patients with myocardial~     diseases, such as ischemic heart disease, cardiomyopathies, and myocarditis.~   "
54505|NCT02853526|"~     To date, there is no treatment strategies for these patients according to American~     Association of the Study of Liver Disease (AASLD) practice guidelines and Baveno V consensus.~     Thus, we aim to compare the safety and efficacy of TIPS and conservative treatment~     (non-selective beta blockers, endoscopic therapy and/or anticoagulation) in patients with PVT~     and CPTV.~   "
54317|NCT02855970|"~     The aim of this work is to develop and validate a scale adapted to French cultural~     characteristics. It will be based on the SS-QoL scale and be simple and quick to use in~     everyday practice. It is not simply a translation. This transcultural adaptation requires~     linguistic and psychometric validation, by studying its validity, its reliability and its~     sensitivity to change, as though it were a new instrument. The investigators will then~     develop a short version by reducing the items and conduct a psychometric validation.~      The translation and validation of a short French version of the SS-QoL scale will generate a~     reliable and sensitive, easy-to-use tool suitable for use in everyday practice.~      The final objective is to use this tool as a principal judgement criterion in future~     therapeutic trials and in patients of the Dijon Stroke Registry to bring to light prognostic~     factors that affect quality of life so as to provide better management of this disease.~   "
54318|NCT02855957|"~     Our project aims to assess and validate an innovative prognostic and diagnostic test in order~     to i) define a severity index of the β-thalassemia according to the free α-Hb pool for a~     better management of the patient; ii) differentiate the α-thalassemia and β-thalassemia and~     iii) follow the evolution of this pool in response to treatment of patients. In the future,~     this prognostic test based on the measurement of free α-Hb pool may be suitable for routine~     laboratory practice. To carry out this project, cohort of 85 thalassemic patients and a group~     of 50 healthy volunteers have been recruited.~   "
54319|NCT02855944|"~     The purpose of this study is to determine how patients with ovarian, fallopian tube, and~     primary peritoneal cancer will best respond to treatment with rucaparib versus chemotherapy.~   "
54320|NCT02855931|"~     Endoscopic sinus surgery (ESS) has become the standard of care for patients suffering of~     chronic rhinosinusitis with nasal polyposis (CRSwP) who have failed medical therapy. The goal~     of surgery is now to widely marsupialize the sinus cavities in order to optimize topical~     steroid irrigation treatment in the postoperative period. With that being said, the true~     extent of surgery needed for optimal patient outcome has yet to be elucidated. More~     specifically, in the last 30 years, people have argued about the best way to manage the~     middle turbinate. Some state that it should be preserved at all times to protect the sinus~     cavities from inhaled irritants and allergens and keep this surgical landmark untouched for~     future surgeries. On the other hand, there are defenders of routine resection of this~     turbinate, whether it is affected by polypoid changes or not. Many studies have looked at the~     potential risks of resecting the middle turbinates such as iatrogenic frontal sinusitis,~     anosmia, or atrophic rhinitis but the more recent literature does not show such significant~     associations. A recent topic of debate is whether partial removal of the anterior and~     inferior portion of the middle turbinate affects nasal polyps recurrence or improves~     long-term outcomes by further facilitation of post-operative topical therapies. Some~     retrospective data has shown that its resection could prolong the time before the need for~     revision surgery and improve both endoscopic and olfaction scores. A few prospective studies~     have also been published but unfortunately none of these were randomized, thus introducing a~     significant selection bias. Thus, there is a need for a formal randomized, controlled trial~     to elucidate this question.~   "
54321|NCT02855918|"~     Suicidal behavior (SB) is a major public health problem in France, with more than 10,000~     suicides and 220,000 suicide attempts per year.~      According to the commonly accepted model for understanding suicidal behavior, individuals who~     carry a suicidal act when subjected to stress factors (environmental stress, depression,~     substance ...) are those which have a specific vulnerability.~      These vulnerabilities can be considered as clinical parameters (propensity to despair,~     aggressive and/or impulsive traits), neurobiological parameters (dysfunction of the~     serotonergic system, ...) and cognitive parameters (taking disadvantageous decision ...).~     Suicidal vulnerability is partly underpinned by genetic factors. The interest of current~     researches is to identify biomarkers that will improve the opportunities for early~     identification of subject with a risk for SB. Numerous scientific studies, including~     post-mortem studies of the brains of suicide completers, have established a link between~     dysregulation of the ribonucleic acids editing (RNA) of certain genes, the enzymatic activity~     of Adenosine deaminases acting on RNA (ADARS) responsible for this edition and suicidal~     behavior. A prospective study is needed to quantify and qualify in the blood of depressed~     patients (with or without a history of suicide) and healthy controls, the editing changes and~     the expression and alteration of the activity of ADARS.~   "
54322|NCT02855905|"~     A cold season involves higher cardiovascular morbidity and mortality. Several epidemiologic~     studies have implicated that persons with a cardiac disease, such as coronary artery disease~     (CAD) may be at higher risk for these adverse health events, but the mechanisms are not well~     established. Because both exercise and cold exposure stimulates cardiac and circulatory~     functions it is important to study their interaction especially among people with CAD and~     whose myocardial oxygen supply and function are weakened. The study examines how recommended~     health-enhancing upper and lower body exercise and warm-up in combination with cold exposure~     affects cardiovascular functions of people with CAD.~      The research includes randomized controlled experiments where the participants are 35-75 year~     old men with CAD (CCS I-II) and recruited from the Oulu University Hospital. Each participant~     undergoes four different trials in random order where the temperature (+22°C or -15°C) and~     the form of exercise (brisk walking at 5.5 km/h or upper body exercise at 30 W), and warm-up~     regime is varied. The used exercise, clothing and exposure resemble an ordinary wintertime~     exercise event. Novel techniques are used to broadly assess cardiovascular function before,~     during and in the recovery phase.~      The obtained information is synthesized and translated to tailored year-round exercise~     instructions for people with CAD by the research team including experts from sports sciences,~     physiology, public and occupational health, clinical sciences and with complementary~     knowledge in physical activity, effective interventions and cardiovascular function. The~     study has broad national and international impact on the relatively passive aging population~     having CAD and residing and working in a cold climate. The produced information enables~     finding means to activate persons with CAD and where appropriate and safe year-round exercise~     may reduce or prevent adverse health effects. Health care personnel will have an improved~     possibility to prescribe physical activity programs for their clients and enabling better~     instructions of healthy and safe exercise as a way to promote health.~   "
54360|NCT02855411|"~     The purpose of this study is to determine whether PF-04958242 is safe and effective in the~     treatment of cognitive dysfunction in schizophrenia subjects~   "
54440|NCT02854371|"~     Liver function is a key factor that can help predict the clinical outcome in patients with~     cirrhosis. Traditionally, liver function was measured using either indocyanine green (ICG) or~     other radionucleotides. Recently, gadoxetic acid has been reported to show liver function in~     several studies. There have been several approaches to measure liver function using gadoxetic~     acid, and hepatocyte fraction is one of the promising methods. Since gadoxetic acid enhanced~     liver MRI is clinically used world widely, it would be valuable if we can measure liver~     function using hepatocyte fraction.~   "
54323|NCT02855892|"~     This clinical trial is designed as a randomized, placebo-controlled, single-blind, parallel~     design, multi-center, phase 2 clinical trial to evaluate the efficacy and safety of GV1001 in~     patients with benign prostatic hyperplasia. Eligible subjects are randomized into a group out~     of the three study groups and a placebo group after four weeks of placebo run-in period.~     Placebo run-in period is concurrently proceeded as a wash-out period for previous treatment~     of benign prostatic hyperplasia, and a placebo is administered intradermally twice with~     two-week interval during this period. After that, the randomized subjects receive a study~     drug and a placebo intradermally seven times with two-week interval by visiting at Week 0, 2,~     4, 6, 8, 10, and 12. After the treatment period, the subjects additionally visit at Week 13~     and 16, and the efficacy is evaluated at Week 4, 8, 12, 13, and 16, and the safety is~     evaluated over the 16-week period.~   "
54324|NCT02855879|"~     The aim of this study is to determine the prevalence of diabetes and non-diabetic glucose~     metabolism anomalies (glucose intolerance, non-diabetic fasting hyperglycaemia in patients~     about to undergo coronary artery bypass grafting (CABG).~      In addition, the effect of these anomalies on post CABG morbi/mortality in the short term~     will be evaluated.~   "
54325|NCT02855866|"~     The scientific interest of this study is to improve post-operative comfort in patients after~     thyroid surgery using simple, inexpensive techniques. The investigator expects that local~     applications of ice or cortisone aerosols will reduce swallowing discomfort and control~     post-operative pain (POP). The investigator hopes that local cryotherapy will decrease~     post-operative oedema (vasoconstriction) and the volume of liquid drained (action on the~     serous fluid at the site of the thyroidectomy).~   "
54326|NCT02855853|"~     Even though cognitive-motor performances are impaired in frail elderly subjects compared with~     healthy elderly subjects, exercising cognitive-motor processes in an implicit manner can~     improve the carrying out of real actions in everyday life.~      No training programme using virtual reality and serious games oriented towards the~     perception/action system has been tested in frail elderly subjects.~      The expected results are:~        -  In the short term, greater strengthening of motor and cognitive abilities in subjects~          trained with the virtual reality and serious games, thanks to stimulation through action~          and through the underlying processes.~        -  In the long term (+1 and +3 months at the end of the training period) better~          preservation of motor and cognitive abilities in subjects who took part in the virtual~          reality and serious games programme.~   "
54327|NCT02855840|"~     Systemic lupus erythematous (SLE), systemic sclerosis (Ssc) and inflammatory myopathy (IM)~     are rare diseases, whose prevalence is estimated at 43, 15 and 10 cases, respectively, for~     100 000 inhabitants in France. These diseases belong to the group of auto-immune diseases and~     require specialized follow-up in an expert centre. The repercussions of SLE, Ssc and IM on~     the everyday life of patients are heavy, and notably linked to skin involvement, to~     diminished functional capacities and psychological problems. The vast majority of these~     diseases concern middle-aged, professionally-active individuals, for whom the~     socio-professional repercussions are major and too often neglected. The aim of this study is~     to analyse the consequences of auto-immune diseases on quality of life. Current quality of~     life questionnaires are not suitable, and do not reveal the reality of the situation and its~     different nuances. In this research, the quality of life of patients will be envisaged~     through their everyday lives. How do these patients construct the social reality of the~     disease? How do they perceive their health status and their social situation? How do they~     organize their everyday lives around the disease: work, leisure, relationships with their~     entourage... ?~   "
54328|NCT02855827|"~     Ovarian cryopreservation is one of the available option for preserving fertility prior to~     potentially sterilizing treatments. In the absence of other techniques such as in vitro~     folliculogenesis or injection of isolated ovarian follicles, this tissue can only be re-used~     by autograft. In France, the first live birth after orthotopic ovarian transplantation, was~     obtained by Roux et al. in 2009.~      This clinical trial aims to build a cohort of patients likely to use their ovarian tissue~     cryopreserved by autograft.~   "
54329|NCT02855814|"~     The American Academy of Pediatrics has recommended that growth in size (weight, length, and~     head circumference) and in body composition (fat and lean mass) in preterm infants should~     adhere as close as possible to the growth and body composition of a healthy infant in utero~     at the same gestational age. However, there are no body composition reference curves~     available at this time for the preterm infant population. The purpose of this study is to~     collect cross-sectional body composition data using air displacement plethysmography (PEA POD~     Infant Body Composition System, Life Measurement, Inc) on approximately 240 preterm infants~     within 3 days of birth, for the purpose of generating means, standard deviations, and~     percentile values for total body fat mass, total fat free mass, and percent body fat for~     infants born at 30-36 weeks gestation. Relatively healthy infants without evidence of growth~     retardation will be selected for form the reference sample. The goal is to generate a set of~     common reference curves to be used in clinical centers against which to compare body~     composition status for individual infants.~   "
54330|NCT02855801|"~     The main objective of this project is to study, in patients with rheumatoid arthritis, the~     effects of an intermittent type exercise associated with cryotherapy on the level of~     inflammation during its recovery.~   "
54331|NCT02855788|"~     phase II study of weekly metronomic chemotherapy using weekly Paclitaxel, Oxaliplatin,~     Leucovorin and 5-FU (POLF) in patients with advanced gastric cancer~   "
54332|NCT02855775|"~     This Study evaluates covariables being able to potentially influence the elimination of the~     monoclonal antibodies (trastuzumab, bevacizumab and denosumab).~   "
54380|NCT02855151|"~     The aim of the EUS registry is to record information about Endoscopic Ultrasound (EUS) on the~     management of gastrointestinal disease. The registry will evaluate efficacy, safety and~     technical success of the Endoscopic Ultrasound (EUS). Design is retrospective and prospective~     registry study.~   "
54381|NCT02855138|"~     The investigators consider that there are some rising concerns about the use of isotretinoin~     by women of reproductive age with depleted ovarian reserve, hence it is important to detect~     the effect of isotretinoin on ovarian reserve.~      There has not been a well-designed study evaluating its effects on the human ovarian reserve,~     hormone levels and menstrual cycles in women with polycystic ovary syndrome (PCOS). For this~     reasons, this study was administered to determine whether there is an effect of isotretinoin~     on the gonads and hirsutism in women with acne and PCOS.~   "
54333|NCT02855762|"~     The objective of this study is to determine how specific dietary control alters the~     microbiome composition to effect clinical outcome measures in a longitudinal study of~     individuals with bipolar disorder. Our central hypothesis is that a low carbohydrate (CHO) /~     high polyunsaturated fat (PUFA) diet will increase the fractional representation of specific~     butyrate producing members of the Firmicutes phylum in the gut microbiome, which will~     attenuate host inflammation, improve sleep quality and reduce anxiety in bipolar patients.~     The rationale for the proposed research is to take the first step in a continuum of studies~     to develop personalized novel approaches to treat mood disorders, including the need to~     address gut dysbiosis, which often co-occurs with mental illness. The investigators will test~     our hypothesis and achieve the objective of this proposal with the following Specific Aims:~     1) Determine the taxonomical change in the stool microbiome following a low CHO / high PUFA~     diet; and 2) Determine the changes in sleep quality, anxiety, and depression following a low~     CHO / high PUFA diet. These aims will be achieved using the unique resources at the~     University of Michigan, including the Nutrition Assessment Laboratory for dietary~     intervention, the Host-Microbiome Laboratory for microbial assays, and the ongoing Prechter~     Longitudinal Study of Bipolar Disorder. At the end of the proposed studies the investigators~     expect to set the stage for future studies to assess neurochemical mechanisms. These data~     will provide a greater understanding of the mechanism by which diet controls the specific~     microbes in the gut microbiome to affect mood disorders and gut dysbiosis and improve~     response to psychiatric treatment paradigms.~   "
54334|NCT02855749|"~     Use of the ultrasound before, during and after percutaneous tracheostomy allows us great~     advantages; anatomy of the pre and paratracheal region and displaying potential aberrant~     vessels, and so the needle and dilator to move away from risk areas and ensure the prevention~     of possible vascular complications. Measuring the distance from the skin into the trachea can~     be done and this allows us to choose the average size tracheostomy tube.~      The aim of this study, In the process of applying percutaneous tracheostomy, to compare the~     reliability of the traditional landmark method, ultrasound-guided long axis in plane~     application and ultrasound-guided short axis out of plane application.~   "
54335|NCT02855736|"~     Suicide is a major health concern. Weeks following psychiatric admission are a highly suicide~     risk period for those having current suicidal ideation or attempt. Recently, a pilot study~     suggested the feasibility of positive psychology in patients in suicidal crisis. Notably,~     gratitude exercises suggested improvement in optimism and hopelessness, two dimensions~     associated to suicide. Moreover, gratitude has been associated to suicidal ideation and~     attempt, independently from depression. Thus, investigators want to conduct the first~     randomized controlled study in order to assess effectiveness of gratitude exercises (vs~     control task) in suicidal inpatients, on 1) psychological pain reduction 2) suicidal~     ideation, hopelessness, optimism, depressive symptomatology, and anxiety improvement.~   "
54336|NCT02855723|"~     Currently, patients with cancer of oral cavity or oropharynx T1-T2N0 classified, are treated~     surgically with systematic lymph node dissection while in 70%, there is no lymph node~     metastasis. The technique of identifying the sentinel node (GS) is validated for these tumors~     because the status of the sentinel node is predictive of the other nodes status in the neck.~     This helps to diagnose the presence of metastases without lymph node dissection and thus~     select patients requiring a treatment node. However, the oncological and functional results~     of a therapeutic strategy based on identifying the GS is unknown.~      This open-label randomized multicenter clinical trial aims to compare the oncologic and~     functional outcome of two strategies : the current management versus the management based on~     the sentinel lymph node.~      The hypothesis is based on a nodal control difference at 2 years in both arms not exceeding~     10%. The medico-economic analysis will be conducted in two stages : a classic stage on 2~     years with estimated incremental cost-effectiveness and incremental cost-utility, then a step~     with log term modeling.~      A reduction in morbidity and treatment costs in the sentinel node arm are expected in this~     study.~   "
54337|NCT02855710|"~     This project aims at assessing the opposite relation, namely the effect of a training of the~     general timing abilities on gait in Parkinson's disease. Timing rehabilitation will be done~     by the means of a serious game. Serious games are more and more used to improve the~     compliance and the efficacy of reeducaiton programs. Overall, we propose to test a low-cost~     tool for rehabilitation.~   "
54338|NCT02855697|"~     PARP inhibitors, such as olaparib, significantly improve progression free survival (PFS) in~     participants with recurrent, platinum-sensitive high-grade serous/endometrioid ovarian cancer~     (HGS/EOC), who harbour a germline mutation in BRCA 1 or 2 genes. Despite some of the most~     impressive hazard ratios seen in ovarian oncology, such improvements in PFS have not~     translated into improved overall survival (OS) advantage potentially because maintenance poly~     ADP ribose polymerase inhibitors (PARPi) are only being administered during a single~     remission. Here the investigators will test the feasibility of administering a second course~     of olaparib in participants who have recurrent platinum-sensitive HGS/EOC.~   "
54339|NCT02855684|"~     Primary Objective:~      To compare the efficacy of insulin glargine (U300) and Lantus in terms of change of glycated~     hemoglobin A1c (HbA1c) from baseline to endpoint (scheduled at Month 6, Week 26) in patients~     with type 2 diabetes mellitus.~      Secondary Objectives:~        -  To compare insulin glargine (U300) and Lantus in terms of occurrence of hypoglycemia and~          nocturnal hypoglycemia.~        -  To compare insulin glargine (U300) and Lantus in terms of reaching target HbA1c values~          (all and reaching target without hypoglycemia).~        -  To compare insulin glargine (U300) and Lantus in terms of controlled plasma glucose (all~          and reaching target without hypoglycemia).~        -  To compare the frequency of occurrence and diurnal distribution of hypoglycemia by~          category of hypoglycemia (documented symptomatic, asymptomatic, nocturnal, severe,~          probable and relative).~        -  To assess the safety and tolerability of insulin glargine (U300).~        -  To assess the development of anti-insulin glargine antibodies (AIA).~   "
54382|NCT02855125|"~     This is a randomized, open-label, Phase 2 study of TAS-114 administered in combination with~     S-1, to investigate the efficacy, safety and tolerability of the TAS-114/S-1 regimen in~     patients with advanced or metastatic NSCLC.~      The study will be conducted internationally in 2 regions: Asian [Japan] and Western [Europe~     and US]. Patients will be randomized into TAS-114/S-1 arm versus S-1 control arm in a 1:1~     ratio.~   "
54340|NCT02855671|"~     The application of infrared thermal imaging in the diagnosis and prognostication of septic~     illness in adults.~      During times of severe infection (sepsis), the small blood vessels supplying oxygen and~     nutrients to the skin and other organs (called the microcirculation), become abnormal and do~     not function as they normally would in health. Monitoring these small blood vessels is~     difficult to do clinically and the investigators want to investigate a new way of doing this.~      The aim of this study is to validate a novel method of assessing the function of the~     microcirculation in healthy volunteers and patients with sepsis, by measuring the skin~     temperature profile of the leg and face with a thermal imaging camera. Thermal imaging~     cameras measure the heat given off by all objects and represents this as a picture, with~     colour used to represent the different temperatures.~      Patients will be recruited from the Emergency Department and Intensive Care Units at~     University Hospitals of Leicester in to one of two groups based on their illness severity;~     uncomplicated sepsis and severe sepsis. Healthy volunteers will be recruited in to a third~     group. Recruitment will take place over a 6-month period with follow-up lasting for 12-months~     following recruitment. 105 participants will be recruited in total.~      Temperature patterns seen on the face and leg will be investigated between the different~     groups. Changes in these temperature patterns as patients recover from sepsis (or indeed~     become worse), will also be investigated. Information from the thermal images will be~     correlated to routinely measured markers of infection, including clinical measurements (blood~     pressure, pulse, etc) and routine blood investigations.~   "
54341|NCT02855658|"~     To evaluate the modulation of immunity-related gene expression for the Sjögren's syndrome~     under Chinese herbal medicine (SS-1) treatment.~   "
54342|NCT02855645|"~     Diabetes mellitus (DM) locates fifth of ten leading death etiology, the population of~     diabetic patients has a tendency of increase. Trichosanthes root is called as Tian Hua Fen,~     According to traditional Chinese writing record that Trichosanthes root has the action of~     downbear fire, moisten dryness, and slippery phlegm, and release thirst. The Trichosanthes~     root may lower blood sugar levels in the modern study. The investigators designed a double~     blind, randomized controlled study, a total of 60 diabetic patients with high blood sugar~     were divided into treatment and control groups, and each group was 30 patients. In the~     treatment group, oral administration of Trichosanthes root 1.5 g, bid/day for 84 days~     continuously; in the control group, oral administration of Trichosanthes root placebo 1.5 g,~     bid/day for 84 days continuously. The main outcome measure was the changes of plasma blood~     sugar and Glycated hemoglobin A1c (HbA1c) levels changed before and after Trichosanthes root~     treatment. The investigators predict the results of the present study indicated that~     Trichosanthes root can improve plasma blood sugar and glycated hemoglobin A1c levels.~   "
54343|NCT02855632|"~     The purpose of this study is to investigate the efficacy of Granulocyte Colony Stimulating~     Factor(G-CSF) on decreasing adhesion reformation and improving fertility outcomes after~     hysteroscopic adhesiolysis in patients with moderate to severe intrauterine adhesions.~   "
54344|NCT02855619|"~     Ventilator-induced diaphragmatic dysfunction appears to contribute to slow weaning from~     mechanical ventilation. Several trials of inspiratory muscle training to facilitate weaning~     in intensive care have been performed, with inconsistent results, utilizing different methods~     of IMT in different populations.~      In this study, the investigators want to compare the incidence of 3 inspiratory muscle~     training programs on inspiratory strength, on difficult to wean patients in intensive care~     unit.~      This is a multi-center randomized trial not blinded with 3 parallels groups:~        -  Martin's group: a threshold-based IMT is performed like used by Martin in a randomized~          trial in 2011, in a view of inspiratory strength increase.~        -  Cader's group: a threshold-based IMT is performed like used by Cader in a randomized~          trial in 2010 , in a view of inspiratory endurance increase.~        -  EDRIC's group: a new treshold-based IMT is performed, in a view of both inspiratory~          strength and endurance increase.~      The investigators think that a new threshold-based IMT performed in a view of both~     inspiratory strength and endurance increase, is more effective and well tolerated than the 2~     others protocols.~   "
54345|NCT02855606|"~     The purpose of this study is to determine the factors associated with acceptability to oral~     HIV pre-exposure prophylaxis (PrEP) among Thai men who have sex with men (MSM) and~     transgender women (TGW).~   "
54346|NCT02855593|"~     The proposed qualitative inquiry seeks to understand medical acupuncture from both the~     physician and the patient perspective. Interviewees will be asked to describe their~     experiences from the point of diagnosis or training up until the present day to capture the~     nature of their experiences across the treatment trajectory. Sample size for the qualitative~     data collection will be based on saturation of themes (thematic findings, e.g., patient talk~     is limited by family knowledge or physician-patient communication is limited by time~     constraints in the clinical setting), meaning investigators will continue recruitment until~     they are no longer hearing new experiences from participants. Saturation will be kept~     separate by groups (i.e., saturation of themes must be met within the group of patients~     separately from providers). Investigators will conduct preliminary data analysis after each~     10 interviews to determine when saturation is reached. Recruitment numbers here are~     anticipated maximum numbers needed to reach saturation. Investigators plan to recruit and~     sample provider and patient populations in the following way. Investigators will group~     physicians by the physician's training so that we are sensitive to the fact that helpful~     patient-physician interaction approaches may differ across the patient's lifespan or with~     patient or physician experience with acupuncture. Audio recordings from each interview will~     be professionally transcribed and analysis will be concurrent with data collection to ensure~     reliability and validity of findings. Investigators will review transcripts as data are~     collected to identify emergent themes and ensure thematic saturation.~   "
54347|NCT02855580|"~     The purpose of this study is to examine the feasibility, acceptability, and utility of~     pharmacogenomic (PGX) testing (specifically for the cytochrome P450 2D6 and 2C19 genes) prior~     to initiating treatment with an antidepressant (AD) among children and adolescents in the~     University of Florida Child Psychiatry clinics.~   "
54348|NCT02855567|"~     This study investigates the role of acupuncture in controlling post-operative pain in~     patients who have undergone gynecological surgery.~   "
54533|NCT02853162|"~     Phase II study (n=30) to evaluate the safety and feasibility of stereotactic body radiation~     therapy (SBRT) with fiducial markers in inoperable patients with renal cell carcinoma (RCC).~   "
54350|NCT02855541|"~     Previous research suggests that prolonged sitting increases risk for cardiometabolic diseases~     and the risk factors associated with cardiometabolic diseases. However, no study to date has~     examined if a chronic intervention that breaks up prolonged sitting in a real-world~     environment results in a reduction in the metabolic risk factors associated with~     cardiometabolic diseases. Thus, the objective of this study is to examine the potential~     health benefits of breaking up sitting bouts throughout the workday using a small cycling~     device (DeskCycle) in office workers involved with jobs that require prolonged bouts of~     sitting. The investigators hypothesize that breaking up sitting will be associated with~     improvements in cardiometabolic disease risk factors. More specifically, the investigators~     hypothesize that breaking up sitting will decrease blood glucose during an oral glucose~     tolerance test (OGTT), increase cardiorespiratory fitness (VO2max), decrease blood pressure,~     decrease body fat, increase HDL cholesterol, and decrease LDL cholesterol, total cholesterol,~     and triglycerides.~   "
54351|NCT02855528|"~     The aim of this study is to prospectively investigate the diagnostic performance and~     potential radiation dose reduction in coronary artery calcium scoring using the new tin~     filter system of the 3rd generation DSCT scanner.~   "
54352|NCT02855515|"~     The main diagnostic challenge in patients with OSA (obstructive sleep apnea) is to determine~     the location of obstruction of the upper airway during sleep. This is so, because the~     otorhinolaryngology examination, which states probable site of obstruction of upper airways,~     is performed in the awake status. Therefore, drug-induced sleep endoscopy (DISE) has been~     introduced in the diagnostic algorithm of OSA patients during the last decade. The advantage~     of DISE is, that the collapse of upper airways, which is not visible during the awake status~     can be observed and targeted therapy according to the location and degree of obstruction of~     the upper airway can be applied. As a result, higher treatment success in patients with OSA~     can be reached.~   "
54353|NCT02855502|"~     tracheal stenosis is the result of abnormal wound-healing processes leading to hypertrophic~     scar formation and obstruction of the airway lumen by excess granulation tissue. This process~     is progressive so treatment and prevention is essential. Resection-anastomosis of the trachea~     is becoming the standard of care in many centers and gives the most consistent results in~     both adult and pediatric patients. But recurrence stenosis, re-granulation and~     re-inflammation are probable. This study aimed to assess the efficacy of systemic~     prednisolone on prevention of recurrent tracheal stenosis after surgery.~   "
54354|NCT02855489|"~     This study has three primary goals. First, to design distinct interventions that target the~     three core constructs of the Theory of Planned Behavior (i.e, attitudes, norms, and perceived~     behavioral control (PBC)). The second goal is to determine which combination of the Theory of~     Planned Behavior constructs is more successful at changing condom use behavior among college~     students. Finally, the investigators will examine the impact change in targeted constructs~     has on those not targeted by an intervention. The current study intends to empirically test~     how the constructs (i.e., attitudes, norms, PBC) in the Theory of Planned Behavior influence~     each other to increase condom use with college students.~   "
54355|NCT02855476|"~     HDClarity will seek to enroll approximately 600 research participants - 500 of whom will be~     at different stages of Huntington's disease (HD) and 100 healthy controls. The primary~     objective is to collect a high quality CSF sample for evaluation of biomarkers and pathways~     that will enable the development of novel treatments for HD. The secondary objective is to~     generate a high quality plasma sample collection matching the CSF collections, which will~     also be used to evaluate biomarkers and pathways of relevance to HD research and development.~   "
54356|NCT02855463|"~     The discovery in 2003 by isolation of amoebas Mimivirus, the world's largest virus at the~     Research Unit on Tropical and Emerging Diseases in Marseille revealed fascinating information~     about the definition and evolution of viruses. Its genome encodes about 1,000 proteins. Three~     other viruses were then isolated from amoebas in this unit:Two other giant viruses, Mamavirus~     Marseillevirus then, and the first virus a virus, named virophage, which led to highlight the~     role of amoeba (Acanthamoeba spp. ) such as spawning giant viruses and compounds of bacterial~     origin or cellular proteins This project focuses on the detection and analysis of new viral~     agents (viruses and virophages giant amoeba environmental) and their involvement in human~     pathology.~      The objectives of this study are observational: detect and document the presence of giant~     viruses and virophages of amoebae in the faeces of children presenting to the pediatric~     emergency reception service of the North Hospital in AP -HM with or without clinical evidence~     of gastroenteritis.~   "
54357|NCT02855450|"~     An 8 Week phase Ib, monocentric, randomized, double-masked, vehicle controlled, parallel~     groups, study with a 24 Week follow-up period to evaluate the safety and potential efficacy~     of a 180 μg/ml recombinant human nerve growth factor (rhNGF) eye drops solution versus~     vehicle in patients with glaucoma.~   "
54358|NCT02855437|"~     The purpose of this study is to determine the feasibility and acceptability of using~     different remote data collection technologies to ascertain flare occurrence among gout~     patients. Two technologies will be the focus of this study: a telephone based interactive~     voice response (IVR) and a smartphone mobile application (called RheumPRO). The results of~     this study will not only guide research approaches in clinical trials, but may also have~     direct implications for monitoring patient outcomes in the context of day-to-day clinical~     practice.~      The investigators hypothesize that acceptability will be greater for RheumPRO application~     than IVR. Additionally, the investigators hypothesize that RheumPRO will be associated with a~     greater frequency of patient-initiated interactions.~   "
54359|NCT02855424|"~     Poor cardiopulmonary endurance is observed in individuals with acute stroke, even in chronic.~     In addition, the poor fitness may obstacle activities of daily life, decrease activities of~     autonomic system, and increase risks of recurrent, therefore, the cardiopulmonary endurance~     training should be included into the early-stage rehabilitation program. The ergocycling~     training could improve cardiopulmonary endurance for individuals with stroke. Moreover, the~     low-intensity exercise training can increase the willingness, and it is safer than the~     moderate-intensity exercise training. However, it needs to be evaluated whether the~     low-intensity exercise training can bring sufficient benefits, compared to the~     moderate-intensity exercise training. Objectives of the study is to compare the exercise~     benefits between the low-intensity and moderate-intensity exercise training, and then these~     would offer optimal exercise prescription and considerations in clinical practice.~   "
54361|NCT02855398|"~     The purpose of this 18-month project is to investigate how decision-making influences food~     choice and consumption in children ages 7 to 11 years old. Although several studies suggest~     that the ability to make good decisions relates to eating behaviors, no studies have looked~     at how food reward influences the decision-making process to impact actual food intake. This~     proposal will answer these questions and bridge this gap in knowledge, which could lead to~     the development of more effective interventions for childhood obesity. To accomplish this,~     the investigators have assembled a diverse team with expertise in food intake, nutrition, and~     decision sciences. First, the investigators will establish if there are differences in~     decision-making between children varying in weight status. Second, the investigators will~     determine if performance on behavioral decision-making tasks relates to food consumption in~     the laboratory. Third, the investigators will examine response functional magnetic resonance~     imaging (fMRI) blood-oxygen-level-dependent (BOLD) response to various rewards (i.e. food and~     money) and determine if this is influenced by child weight status. Fourth, the investigators~     will examine differences in fMRI BOLD at rest in decision-making regions are correlated with~     food intake and weight status. Eighty-two children will participate in our study. The~     long-term goal of this project is to investigate if there are differences in brain regions~     corresponding to these behaviors in overweight children and if these differences relate to~     eating behaviors in this population. Children will undergo fMRI while playing a reward task~     as well as consume meals in our laboratory. Decision-making will also be assessed by having~     children complete various behavioral measurements of reward and inhibitory control.~   "
54362|NCT02855385|"~     This study sought to find the health seeking behavior of patients with rectal bleeding as~     related to their risk to develop colorectal cancer and also assess the general practitioner's~     perceived barriers to colonoscopy for patients with bleeding per rectum.~   "
54363|NCT02855372|"~     It is commonly accepted that the characteristics of the organ donor impact on the future post~     transplant. In lung transplantation (LP), the defining characteristics of the ideal donor~     includes an age less than 55 years. However, before the pulmonary graft shortage with a~     corresponding mortality still too high waiting list, the lung graft acceptance criteria were~     reassessed permitting criteria extension ( marginal graft). And were grafted, depending~     on the urgency and accessibility problems in the registry of potential candidate, organs from~     donors aged 55 and older with quite comparable to those obtained from younger donors .~     Nevertheless, it is common practice that the grafts from older donors are more readily~     allocated to older candidates and the most severe, as many confounding factors to assess the~     real impact of donor age on post-transplant evolution on small cohorts.~      The main goal of this study is to compare the survival of lung transplant patients depending~     on the age difference between donor and recipient.~      The study will be conducted from a broad national cohort of lung transplant patients~     registered in COLT ( Lung Transplantation COhort). Established in September 2009, promoted by~     the University Hospital of Nantes, COLT involves 11 lung transplant centers authorized on~     French territory. It provides a standardized common longitudinal monitoring of the recipient~     from his transplant. Currently more than 1,000 patients included in this study are~     transplanted.~   "
54364|NCT02855359|"~     This is a Phase 2 study to evaluate the combination of denintuzumab mafodotin in combination~     with RCHOP or RCHP compared with RCHOP alone as front-line therapy in patients with diffuse~     large B-cell lymphoma or follicular lymphoma Grade 3b.~   "
54365|NCT02855346|"~     PK and Safety Study of Vaginal Ring Containing Dapivirine and Levonorgestrel~   "
54366|NCT02855333|"~     The purpose of this study is to analyse retrospectively the early postoperative and~     functional outcome of patients (pts) after Merendino procedure for benign or early malignant~     lesions of the distal part of the esophagus or the gastroesophageal junction.~   "
54367|NCT02855320|"~     Background : Inflammatory arthritis (rheumatoid arthritis (RA) or spondyloarthritis (SpA) are~     painful chronic diseases which impair quality of life and work capacity. Biologics are very~     effective and widely used therapies. However, they are known to entail risks, particularly of~     infections. The risk of severe infections is of 5%/patient-year with a maximum during the~     first six month after the initiation of the first biologic therapy.~      Patient education (PE) is recommended for the management of chronic diseases. In the case of~     biologics, PE aims to help patients to learn specific skills particularly on safety issues,~     e.g stopping the biologic treatment in case of fever or surgery. Safety skills are assessed~     by the validated BIOSECURE questionnaire. PE seems efficient for safety skills in a few~     non-randomized studies. In 2010 a national cross sectional survey on 677 patients showed that~     the risk of incorrect answers in the BIOSECURE questionnaire was 4 times lower among patients~     who had benefited from an education by a nurse or other kind of educational process (OR =3,8~     IC95% :[1,68-8,8].~      Aims and Hypothesis: this trial aims to investigate the effects of a nurse-led~     self-management education face to face intervention on safety skills of patients with~     arthritis treated par sub cutaneous biologics. Our hypothesis is that the intervention group~     will report better skills at the 6 months follow up compared to usual care i.e information by~     the rheumatologist in current consultation.~      Methods : multicentric randomized controlled open trial with blinded assessment of the~     primary outcome. The intervention group will have a nurse education consultation at M 0 and~     M3 in addition to the usual care by the rheumatologist. The nurse will assess the patients'~     health beliefs and educational needs, focusing on safety skills, self-injections and~     motivation. The control group will have usual care by the rheumatologist.~   "
54368|NCT02855307|"~     Regular physical activity is associated with many health benefits for individuals with type 1~     diabetes including improved cardiovascular fitness and vascular health, decreased insulin~     requirements, improved body composition and quality of life. However, exercise-induced~     hypoglycemia is very frequent and thus is the main limiting factor for physical activity~     practice in this population.~      The artificial pancreas is composed of three components: glucose sensor to read glucose~     levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the~     required insulin dosages based on the sensor's readings. The artificial pancreas has the~     potential to reduce the risk of exercise-induced hypoglycemia but the importance of~     announcing exercise to the artificial pancreas is yet to be explored.~      The objective of this study is to investigate 1) if announcing postprandial exercise to the~     artificial pancreas is beneficial in reducing the risk of hypoglycemia and 2) if an insulin~     bolus reduction is necessary when announcing the exercise to the artificial pancreas.~   "
54441|NCT02854358|"~     Head and neck cancers(HNC) is one of the most common cancers worldwide. Xerostomia is one of~     the most common side effect of radiation therapy among patients with HNC. Mouth dryness~     significantly impairs patients' quality of life (QOL).~      HNC.Regarding to traditional use of A. digitata and M. sylvestris in addition to known their~     beneficial effects in recent studies, we decided to design a randomized, controlled clinical~     trial to try to evaluate efficacy of the these herbs in QOL of HNC patients with radiation~     induced xerostomia~   "
54369|NCT02855294|"~     1. Recording Data Sheet:~           All data and information of each woman in both groups (A & B) participated in this study~          were recorded in a recording data sheet (Appendix II).~        2. Weight-Height scale:~           A valid and reliable weight -height scale, with a range of 1 to 150 kilograms weight,~          and 1 to 200 centimeters height was used to measure the relevant subject's data.~        3. Siemens Immulite Immunoassay System:~           (Siemens Medical Solutions Diagnostics Immulite 1000,Los Angles, CA, 900-456900 U.S.A)~          to measure the serum Progesterone and Estradiol levels in both groups (A& B) using (TKE~          21 Kit) for Estradiol and (TKPG 1 Kit) for Progesterone.~        4. Biodex balance system:~      Biodex Balance System (BBS), P.O. Box 702, Shirley, Ny 11967.It is an apparatus used to~     measure the dynamic balance. It utilizes dynamic multi axial platform. This platform allows~     approximately 20 degree inclination in 360 degree range and is interfaced with computer~     software. It measures the patient's ability to control the platform's angle of tilt, which is~     quantified as a variance from the center, as well as the degree of deflection over time at~     various stability levels as shown in (Fig. 6).~      Stability levels allowed by the system ranged from one to eight. Stability level 8, allows~     the highest level of stability as it makes the platform to be the least tilted. On the other~     hand, stability level one represents the least level of stability and is more difficult for~     the subject to maintain stability on.~      The test consists of recording the patient's ability to control the platform variance from a~     perfectly balanced position. A large variance is indicative of poor control and balance.~     Further definition is realized with the quantification of Anterior/ Posterior and~     Medial/Lateral responses.~   "
54370|NCT02855281|"~     This is a prospective diagnostic pilot study to create hypotheses regarding~     immunocytochemistry (ICC) PD-L1 analysis of pleural effusions in NSCLC patients as compared~     to the reference standard of PD-L1 immunohistochemistry (IHC). This comparison will be done~     to assess sensitivity and specificity of PD-L1 detection by ICC in pleural effusions.~   "
54371|NCT02855268|"~     This is a randomized, double-blind, placebo-controlled, multi-center, Phase 2 study of the~     safety and efficacy of RG-012 administered to male subjects with Alport syndrome.~   "
54372|NCT02855255|"~     The proposed study will compare the efficacy of two psychological stop smoking interventions.~   "
54373|NCT02855242|"~     The human gut microbiota has become the subject of extensive research in recent years,~     particularly in regards to the role it plays in obesity. Although lifestyle factors, diet,~     and lack of exercise contribute largely to this obesity epidemic, there is increasing~     evidence that the human gut microbiota also influences weight gain.~      The investigators hope to learn more information about the change in gut microbiota,~     especially with regards to those who are successful with weight loss, versus those who don't~     lose weight, after participating in a lifestyle modification program at the Dan Abraham~     Healthy Living Center (DAHLC).~   "
54374|NCT02855229|"~     The overarching goal of this multi-disciplinary research program is to develop and optimize~     new cross-species translational assessments of reward and cognition that will not only be~     assessed in parallel in humans and rats, but also produce neurophysiological and behavioral~     metrics that can be objectively compared across species. The research will build on prior~     studies by further developing and optimizing (in Phase 1), then validating via~     pharmacological challenge (in Phase 2), the following assays in both humans and rats:~        1. advanced neurophysiological and computational modeling techniques to record and analyze~          EEG activity within and across species; and~        2. behavioral assessments of reward learning, cognitive control, and cognitive flexibility~          will be analyzed within and across species.~      The second phase of the study will test the translational validity of these assays, by~     assessing the impact of a targeted drug on task performance and EEG activity in both species.~   "
54375|NCT02855216|"~     The cervical spine should work as a functional unit. If hypomobility should exist in any of~     the segments it would limit the mobility of the spine as a whole. Although it is frequent~     that certain cervical segments present hypomobility, they are not always related to~     symptomatology. The effects of inhibition sub-occipital techniques on cervical mobility have~     not been evaluated.~      The objetive of this trials is to assess and compare the effects on cervical mobility, of the~     manual technique of sub-occipital inhibition by applying pressure and self-treatment by way~     of Occipivot® cushion, in subjects with no cervical symptomatology but with limited mobility~     assessed by the flexion-rotation test.~   "
54376|NCT02855203|"~     This investigator driven study will examine the safety, efficacy and biological effects of~     combining pembrolizumab (MK-3475) an antibody targeted against anti-programmed cell death 1~     (PD-1), with stereotactic ablative body radiotherapy (SABR) for oligometastatic renal cell~     carcinoma (RCC). The investigators hypothesise that the safety profile of this combination~     will be clinically acceptable.~   "
54377|NCT02855190|"~     This is an open-labelled two-arm pilot comparative prospective study. All the subjects will~     undergo image assessment in the two stages of exchange arthroplasty surgery. At the first~     stage, each enrolled subject will receive both FDG and Ga68 citrate PET/CT scans before the~     first operation for periprosthetic Joint Infection (PJI). Thus, the test results of FDG and~     Ga68 for each individual can be obtained. After the first operation, the surgery/biopsy proof~     can be obtained as the gold standard. The subjects those with PJI negative will complete the~     process at the first stage.~      And the second stage of this study will be based on the subjects with positive PJI from the~     first operation. They will receive both FDG and Ga68 citrate PET/MR scans after antibiotic~     bone cement was implanted. The sensitivity/accuracy of the two tracers for PET/MR can be~     calculated and compared. This stage is aimed to answer whether PET/MR scan is a feasible~     imaging tool to provide diagnostic information of infection control status after the~     resection arthroplasty of hip/knee PJIs, especially with the implantation of antibiotic~     loaded bone cement.~      In the second stage, the investigators shift the imaging modality to PET/MR based on the~     following reasons: (1) MRI itself has no radiation burden; (2) MRI provides more accurate~     tissue contrast information and therefore better anatomic delineation; and (3) currently~     there was no study indicating the existence of ABLC may hamper the interpretation of images.~      The study duration is expected to be completed in a period of 3 year. It plans to enroll a~     total of 50 subjects with suspicious infection. And the investigators expect the PJI~     prevalence will be around 60%, i.e. the anticipated number of subjects of true PJI is around~     30. The sample size and the prevalence is given based on the clinical availability and~     consideration.~   "
54378|NCT02855177|"~     PF-06427878 is a new compound proposed for the treatment of hyperlipidemia. The primary~     purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics after 2~     weeks of dosing of PF-06427878 in overweight-obese, otherwise healthy adult subjects.~   "
54379|NCT02855164|"~     The purpose of the study is to assess the effects of different doses of tropifexor (LJN452)~     with respect to safety, tolerability, and on markers of liver inflammation in patients with~     NASH~   "
54383|NCT02855112|"~     Spinal Muscular Atrophy (SMA) is an autosomal recessive disease of motor neurons. In the~     early 1980s, Werdnig from Vienna University and Hoffman from Heidelberg University described~     this disorder. So SMA type 1 was named Werdnig- Hoffman disease. This is the first genetic~     disorder that cause death after cystic fibrosis in infants with the prevalence of 1 in 6000~     birth. Mutation in the SMN1 gene (Survival Motor Neuron) is the reason for the disease that~     cause decrease in the SMN protein production. So the alpha motor neurons in the spinal cord~     ventricle horn will be destroyed and it cause progressive paralysis and defenite death.No~     specific therapy is yet available for the treatment of Werdnig-Hoffmann disease. Treatment is~     not disease-modifying and just is supportive. SMA type 1 is diagnosed within the early 6~     month after birth and accompanied with breath disorders and definite death in 2 years. The~     affected infants have a weak muscle tone and they couldn't even hold their head up. Perhaps~     the only open way for these patients is the application of stem cells that could deliver~     trophic factor to the apoptotic cells. So this study focuses on the effectivness of cell~     therapy via adipose derived mesenchymal stem cells on the probable phenotypic changes in~     these patients.~   "
54384|NCT02855099|"~     Many patients we encounter a month post TAVI, still complain of having symptoms limiting~     their daily activity. The investigators set out to study whether rehabilitation strategy~     early after the procedure contributes to reduction of the physical disability these patients~     suffer from.~      Cardiac rehabilitation (CR) is a well-established treatment in patients who underwent cardiac~     surgery. Patients after TAVI, are natural candidates for referral to exercise-based CR.~     Despite this, until 2013 no data have been available about the safety and the efficacy of a~     comprehensive rehabilitative period in these subjects. CR is a helpful tool to maintain~     independency for daily life activities and participation in socio-cultural life. despite~     these differences, both patient groups did benefit in the same way from a post-acute~     in-patient rehabilitation program as assessed by 6-Minute Walking Tests and FIM scores.~     Patients who were unable to walk and those were slow walkers at baseline experienced an~     improvement in functional status after TAVI, whereas the fast walkers did not improve and~     actually experienced a modest decrease in 6MWTD.It has been shown that patients referred for~     rehabilitation after TAVI are often very frail, with a high grade of functional impairment,~     dependence on others and high risk of clinical complications. During a rehabilitation~     program, based on a multidimensional assessment and intervention, most patients showed~     significant improvement in functional status, quality of life, and autonomy, which remained~     stable in the majority of subjects during mid-term follow-up.~      To the investigators knowledge, no prospective study compared rehabilitation strategy to~     conservative treatment after TAVI. the investigators set off to test the investigators~     hypothesize that CR may help in the short and long term prognosis of these patients.~   "
54385|NCT02855086|"~     This study is a phase 1-2 trial that evaluates the best dose of cetuximab-IRDye 800CW and how~     well it works in detecting tumors in patients with malignant glioma who are undergoing~     surgery. Cetuximab-IRDye 800CW is an optical imaging agent that may help detect tumor cells~     when a special camera is used.~   "
54386|NCT02855073|"~     The purpose of this study is to evaluate the effectiveness of ReJoinTM for the Knee~     Osteoarthritis patients with Cartilage Defects comparing to Sodium Hyaluronate Injection.~   "
54387|NCT02855060|"~     The purpose of this study is to determine whether the use of pelvic binders in the ambulance~     setting improves outcomes including mortality in patients with pelvic fractures.~   "
54388|NCT02855047|"~     The primary objective of this study is to evaluate plasmatic concentrations of free PGF and~     sFlt1 for blood samples taken before a first low-molecular-weight-heparin injection and also~     for blood samples taken on the 4th day of injections (the latter correspond to the first~     systematic control of platelet counts) in women who have an obstetric antiphospholipid~     antibody syndrome and who are initiating a new pregnancy with recommended treatment. Our goal~     is to test the prognostic value of these data on the occurrence of:~        -  pregnancy loss categorized as embryonic loss (before 10 weeks gestation), fetal death~          (before 20 weeks gestation), stillbirths (from 20 weeks gestation to delivery), and~          neonatal death defined before reaching 28 days of age.~        -  ischemic placental pathology (pre-eclampsia, retro-placental hematoma, birth of a~          small-for-gestational-age infant)~   "
54389|NCT02855034|"~     Head injury is a frequent motive of consultation in paediatric emergency units and the first~     cause of mortality in infants of more than one year old in developped countries. The~     indication of performing cerebral CT scans currently depends on clinical decision based on~     recommendations used in adults. In this way, 60 to 90% of scans are normal in children with~     head injury. CT scan is expesive and irradiating with the risk of increasing the cancer in~     children. Protein S 100B and copeptine are biomarkers which have shown their ability to~     detect cerebral lesion in children with head injury. (protein S 100B and /or in adults~     (protein S 100B and copetine.~      It is the first clinical biological evaluation of severity of head injury based on dosing of~     copeptine alone or associated with proein S 100B.~   "
54390|NCT02855021|"~     Parkinson's disease (PD) is a common disease. Dementia will affect 80% of these patients~     during their evolution. In addition, treatments of motor signs have a potential impact on~     these disorders and conversely.~      The purpose of this study is to show focal abnormalities in brain metabolism in the precuneus~     and posterior cingulate region are predictive of the onset of dementia within 2 years.~   "
54391|NCT02855008|"~     Aggressive/challenging behaviors in individuals with intellectual disability are a major~     public health concern for them, their families, their service programs and staff, and their~     communities. This randomized clinical trial will test the efficacy and cost effectiveness of~     a preventive community-based social problem solving intervention, the Steps to Effective~     Problem-solving (STEPS), delivered in group homes. The program uses residential staff~     participation and the group environment to facilitate improved social problem solving skills~     and reduce aggressive/challenging behaviors in this population in group homes and work~     settings.~   "
54418|NCT02854657|"~     The proposed study is a continuation of a research program (STU00017005: Interventions to~     teach melanoma patients skin self-examination) designed to increase early detection of~     melanomas before they metastasize. In 2015, approximately 73,870 individuals in the U.S. will~     be diagnosed with invasive melanoma and about 9,940 will die from the disease. During~     2002-2011, melanoma incidence increased at an average annual rate of 1.6% for men and 1.5%~     for women. People with a history of melanoma have 10 times greater risk of developing a~     second primary melanoma relative to the general population.Early detection with surgical~     excision at an earlier stage when treatment is usually more effective is the only proven~     curative strategy.~   "
54419|NCT02854644|"~     This study evaluates the frequency of the spontaneous T cells specific CD4 answers of tumoral~     antigens breast cancer and glioma.~   "
77829|NCT02548273|"~     This study aims to assess the corneal damage after phacoemulsification and to assess the~     factors causing it in diabetics in comparison with non-diabetics.~   "
54392|NCT02854995|"~     Traditionally, BXO is managed with circumcision (surgical removal of the foreskin) and this~     approach has long been held as the 'gold standard. Whilst this may be curative in many cases,~     it has been shown that 20% of boys require a further operative procedure on their penis to~     widen the urethral opening (to treat meatal stenosis)~      An alternative to circumcision was proposed: a preputioplasty (surgery to widen the opening~     of the foreskin) was combined with injection of steroids into the affected foreskin.~     Subsequently, the same group compared the outcomes of this technique with circumcision, and~     reported circumcision was successfully avoided in 92% of the preputioplasty group. In~     addition, the rate of meatal stenosis (narrowing of the urethral opening requiring surgery)~     was significantly lower (6% vs 19%, P = .034 ). Preputioplasty may therefore: (i) offer~     protection against meatal stenosis and reduce the requirement for further surgery; and (ii)~     offer the benefit of retaining the foreskin, the function of which, while debated, likely~     includes sexual function. In view of these potential benefits, authors have called for a~     randomised trial to compare circumcision to preputioplasty and injection of steroids.~   "
54393|NCT02854982|"~     To study the quality of life of patients with prostate cancer at a distance from their care~     at a time when they are supposed to have taken a normal life and compared to subjects~     without cancer prostate of the same age.~   "
54394|NCT02854969|"~     Through several questionaries the investigators will measure the satisfaction of patients~     diagnosed with anaphylaxis in the use of a medical device for the adrenaline autoinjector, a~     smart case for an epinephrine autoinjector connected via Bluetooth to a mobile application.~   "
54395|NCT02854956|"~     X-linked Mental retardation (XLMR) represent 10% of the causes of mental retardation with a~     prevalence in both sexes around 1/296, i.e. 3.3 / 1000 births (Opitz et al., 1986). This~     heterogeneous group of XLMR includes dozens of rare diseases, some of them affecting only a~     few patients. Molecular diagnosis is currently available in France for 25 XLMR genes, within~     the national network of XLMR molecular diagnosis. However, whereas some syndromes such as~     Fragile X syndrome, are now well clinically defined, this is not the case for recently~     identified syndromes for which very few data is available, preventing clinicians to focus~     molecular diagnosis on a specific gene.~      Therefore, this study aims to :~        -  Achieve a description of the clinical phenotype specific to each XLMR gene (Phase 1 of~          the study, n=200)~        -  Characterize the cognitive learning mechanisms and dysfunctional neural networks~          involved (Phase 2 of the study, n=75, i.e. 5 groups of 15 patients with a mutation in~          the same gene). These two elements constitute key steps to develop appropriate~          rehabilitation strategies and targeted pharmacological therapies.~      Moreover, the impact of mental retardation on the primary caregiver within the family and the~     induced burden in terms of psycho-social, organizational and economic burden will also be~     assessed. These elements, directly related to the patient's environment, are very important~     to characterize in order to better understand the consequences of each gene mutation (Phase 3~     of the study, n=283). For example, it is necessary to better understand the impact of Fragile~     X syndrome in terms of capacity and behavior, lifestyle, and health care needs of the~     patients While advancing knowledge allows to consider innovative therapeutics, the~     implementation of these therapeutics and assessment of their impact on the patients' life~     trajectory, require precise characterization of the population to be treated in medico~     socioeconomic terms.~   "
54396|NCT02854943|"~     Retrospective analysis of ferritin, outcome and HLH-criteria in critically ill patients.~   "
54397|NCT02854930|"~     Migraine is a common disabling primary headache disorder. Epidemiological studies have~     documented its high prevalence and high socio-economic and personal impacts. Migraine affects~     more than 20% of the French population. However, the physiopathology of migraine is always~     partially known. Cortical spreading depression (CSD) is the widely accepted as the~     electrophysiologic substrate of migraine aura. CSD is a slowly propagating wave of transient~     neuronal and glial depolarization. The near death experience (NDE) is a rare, but well known~     phenomenon. NDE are profound psychic experiences commonly occuring in life-threatening~     conditions. Among the neurological hypotheses, epilepsy, temporal lobe disorders , REM-sleep~     intrusion have been discussed. However, the role of DCE has never been discussed. The goals~     of this study are : to see if there is an epidemiological link between NDE and migraine/ to~     specify if NDE was followed by a migrainous headache.~   "
54398|NCT02854917|"~     This study is a retrospective review of the data collected in a previously completed~     randomized, controlled trial (RCT) entitled Memantine and Comprehensive, Individualized,~     Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial~     (NCT00120874). As part of the previously completed RCT, participants with Alzheimer's Disease~     (AD) were randomly placed into one of two groups: memantine, or memantine plus an~     individualized management program consisting of home visits, educational sessions for~     caregivers, and a caregiver support group. Participants received the study intervention for~     28 weeks; study follow-up lasted for 52 weeks.~      The collected data from the existing study books from the 28 week treatment portion of the~     RCT will be carefully examined with respect to each of the research questions for the present~     retrospective study.~   "
54399|NCT02854904|"~     Alpha-agonist in anesthesia display immunomodulatory effect in addition to antiadrenergic~     control. This effect of the immune system can be a key to a better perioperative safety and~     quality.~      The association of dexmedetomidine at general anesthesia adds up organic protection and~     inflammatory control to a surgery trauma owing to antinociception and immunomodulatory~     effect.~      The aim this study is evaluate if the association of dexmedetomidine at general anesthesia~     standing effective immunomodulatory control to trauma and improve changes at outcomes in~     patients undergoing to spinal fusion.~   "
54400|NCT02854891|"~     Myopia, the most common human eye disorder, is a phenomenon characterized by an unconstrained~     elongation of the eye globe There are number of theories concerning the environmental effect~     on the emmetropization process, most are related to childhood exposure to outdoor activity,~     near work and sleep with night light. Studies in lab animals found an association between~     intensity of ambient lighting and myopia development.~      In this study, the investigators will examine the ambient light in kindergarten and schools~     and their relation to refractive error. Diurnal luminance in kindergarten and school class~     room will be measured and correlated to biometric measures such as refraction, axial length~     and keratometry.~   "
54401|NCT02854878|"~     A pilot study to evaluate safety and efficacy of the Lucy combined with LucyGel in killing~     head lice and their eggs.~      23 participants will be enrolled in this study. The first 12 will be combed with model A and~     the remaining 11 will be combed with model B~   "
54420|NCT02854631|"~     The primary objective of this study is to evaluate the safety and tolerability of selonsertib~     (GS-4997) in combination with prednisolone versus prednisolone alone in participants with~     severe alcoholic hepatitis (AH).~   "
54421|NCT02854618|"~     This study evaluates the immune response for patients affected by metastatic breast cancer~     treated by everolimus~   "
54402|NCT02854865|"~     Determining the LV filling pressure is a key element in the diagnosis and management of~     patients with suspected decompensated heart failure. The aim of the present study is to~     assess whether a systolic 2D-STEderived parameter, global longitudinal peak systolic strain~     (GLPSS), acquired by transoesophageal echocardiography (TEE) is superior to the E/Ea ratio in~     the estimation of the LVFP measured as the pulmonary capillary wedge pressure (PCWP) in~     patients during cardiac surgery. Automated function image (AFI) algorithm is a novel method~     based on 2D strain imaging that enables the simultaneous quantification of myocardial strain~     in different left ventricular segments; its 3-click method minimizes variability related to a~     manual training of endocardial border required in an usual 2D-strain analysis.~      AFI provides GLPSS by averaging mid-oesophageal 4-, 2- chamber and long axis views. The study~     is a prospective observational single-center cohort study. 30 Patients scheduled for elective~     cardiac surgery will be included in the study group. The study is designed to assess whether~     GLPSS measured during cardiac surgery using AFI is superior to E/Ea ratio in estimation of~     LVFP measured as PCWP.~   "
54403|NCT02854852|"~     Changes in the vascular tone of anesthetized patients is common and cause hemodynamic~     problems. The monitoring of such changes in vascular resistance using simple and non-invasive~     tools is lacking. The present study was designed to determine if photoplethysmography can~     detect changes in the systemic vascular resistance using Doppler as the reference method.~   "
54404|NCT02854839|"~     The propose of this study is evaluate the safety and efficacy of MG4101 (allogeneic Natural~     killer cells) in patients with hepatocellular carcinoma (HCC) after transarterial~     chemoembolization (TACE).~   "
54405|NCT02854826|"~     Systems Addressing Frail Elders (SAFE) Care is a nurse-led interprofessional team model to~     rapidly identify and provide safe and effective inpatient care to high risk older adults and~     help support their successful transition back to the community. Developed and demonstrated to~     be effective in one hospital - the model is now being disseminated and studied in three~     additional hospitals (multiple organizational case study).~   "
54406|NCT02854813|"~     Investigators aimed to investigate the association between over active bladder and coronary~     artery disease as demonstrated on coronary angiography.~   "
54407|NCT02854800|"~     The purpose of this study is to examine the effectiveness of a smoking cessation intervention~     for cigarette smokers enrolled in an outpatient program for opioid dependence. Treatment~     effects will be compared as a function of phase in the outpatient program: 0-90 days, 90~     days-1 year, and more than 1 year.~   "
54408|NCT02854787|"~     The purpose of the study is to determine if an intravenous bolus of phenylephrine is more~     effective compared to an intravenous bolus of norepinephrine associated with crystalloid~     loading for maintaining blood pressure during a spinal anesthetic for a cesarean delivery.~     Prevention of low blood pressure has been shown to decrease nausea and vomiting during and~     after cesarean delivery under spinal anesthesia. For elective cesarean delivery, all~     participants will receive spinal anesthesia with a local anesthetic and sufentanil. This~     study plans to enroll 120 pregnant women. Patients will be randomly assigned according to a~     computer generated system to be in one of two groups.~   "
54409|NCT02854774|"~     This is a randomized controlled trial of knee muscle versus hip muscle strengthening for~     Patellofemoral Pain Syndrome.~   "
54410|NCT02854761|"~     This study evaluates the safety and tolerability of the investigational drug EF-022 in the~     treatment of adult patients with Recurrent Respiratory Papillomatosis (RRP). Patients will be~     administered EF-022, either intramuscular or subcutaneous, for a period of 6 months.~     Preliminary effect of the drug on the disease will be evaluated by following the number and~     severity of the lesions in the respiratory tract and the effect on voice changes.~   "
54411|NCT02854748|"~     This study is a randomized, open-label, multiple dosing, crossover study to evaluate the~     drug-drugs interaction between Lobeglitazone and Empagliflozin in healthy male volunteers~   "
54412|NCT02854735|"~     The purpose of this study is to define the role of total body composition in the guidance of~     nutritional support and treatment monitoring in head and neck patients. Furthermore, the~     second aim of this study is to compare the clinical performance of dual energy X-ray~     absorptiometry as compared to CT in evaluating total body composition of patients.~   "
54413|NCT02854722|"~     In 2006, Weinberg proposed a hypothesis that iron accumulation was a risk factor for~     osteoporosis. Osteoporosis is a common complication in various diseases, such as~     hemochromatosis, African hemosiderosis, thalassemia, and sickle cell disease, which all share~     iron accumulation as a common denominator. Moreover, a 3-year retrospective longitudinal~     study has shown that iron accumulation was also associated with osteoporosis in healthy~     adults and especially that it can increase the risk of fractures in postmenopausal women.~     Based on these observations, iron chelation therapy may have a promising future in the~     treatment of iron accumulation-related osteoporosis by removing iron from the body.~      The purpose of this study is to determine whether the addition of the iron chelator,~     deferasirox, to standard therapy for postmenopausal osteoporosis, is safe and effective.~   "
54414|NCT02854709|"~     This is a randomized cross over study of the effect of 2-week sleep extension in chronically~     sleep deprived non-diabetic individuals on glucose metabolism.~   "
54415|NCT02854696|"~     The main goal is to perform a cost-utility analysis to compare islet cell transplantation~     versus best medical treatment (defined as Sensor augmented pump therapy) for patients with~     brittle type1 diabetes.~   "
54416|NCT02854683|"~     We and others have shown that many younger patients with Myalgic Encephalomyelitis/Chronic~     Fatigue Syndrome (ME/CFS) have orthostatic intolerance (OI), i.e., they can't tolerate~     prolonged standing. OI in ME/CFS is often accompanied by either postural tachycardia syndrome~     (POTS) in which standing results in an excessive heart rate, and neurally mediated~     hypotension (NMH) in which standing causes a fall in blood pressure and fainting. Intravenous~     fluids can alleviate these symptoms, but is difficult to administer; oral fluids fail to~     provide the same benefit. We would therefore like to test the effectiveness of an oral~     rehydration solution (ORS, W.H.O. formula) making use of co-transport of glucose and sodium,~     to reverse these symptoms in ME/CFS subjects with POTS or NMS, and will compare these results~     with healthy control subjects.~   "
54417|NCT02854670|"~     This study aims to assess the pain on contact in provoked vestibulodynia, measured with~     Visual Analogic Scale at week 0/week 2/week 6/week 12 after applying a patch of capsaicin.~   "
54423|NCT02854592|"~     Stroke is one of the leading causes of death and disability in China. Intravenous~     thrombolysis with recombinant tissue plasminogen activator (rtPA) improves the outcome for~     ischemic stroke patients who can be treated within 4.5 hours of symptom onset. In China, in~     addition to rt-PA, intravenous urokinase within 6 h has also been recommended by the 2010~     Chinese Guidelines for the Diagnosis and Treatment of Patients with Acute Ischemic Stroke,~     and supported by evidence from two intravenous urokinase thrombolysis trials. Urokinase is~     used more frequently than rt-PA, mainly because it is cheaper. To describe Chinese experience~     with thrombolytic therapy for Ischemic Stroke within 4.5h onset, we designed a multicenter,~     prospective, registry study. The aim of INtravenous Thrombolysis REgistry for Chinese~     Ischemic Stroke within 4.5 h onset（INTRECIS）was to assess the safety and efficacy of~     intravenous rtPA, urokinase as thrombolytic therapy within the first 4.5 h of onset of acute~     ischaemic stroke.~   "
54424|NCT02854579|"~     The purpose of this study is to investigate the efficacy and safety of allogenic neural~     progenitor cell and paracrine factors of human mesenchymal stem cells for patients with~     moderate/severe Hypoxic-Ischemic Encephalopathy~   "
54425|NCT02854566|"~     Observational retrospective study on 36 consecutive patients having had surgery for a~     periprosthetic fracture of the femur between 2010 and 2015.~      The goal of the study is to test whether osteosynthesis was a secure choice at a certain age~     and with any type of Vancouver fracture.~   "
54426|NCT02854553|"~     The transversus abdominis plane (TAP) block is an effective regional nerve block for the~     anterior abdominal wall. An anesthesiologist typically administers the TAP block~     preoperatively with ultrasound guidance. It is not yet commonly used during anterior~     abdominal wall liposuction, where postprocedural pain remains a major concern for patients~     and surgeons.~   "
54427|NCT02854540|"~     This study will evaluate the use of hydrogel electrode pads (rather than tap water baths) to~     deliver iontophoresis treatment using a traditional iontophoresis device. Participants will~     treat one hand with the hydrogel-based iontophoresis device and leave the other hand~     untreated.~   "
54428|NCT02854527|"~     Main objective is to investigate mutual pharmacokinetic drug-drug interactions of digoxin,~     furosemide, metformin, and rosuvastatin when given all together as a cocktail~   "
54429|NCT02854514|"~     For all women immediately after ovum retrieval from 80 women undergoing IVF, intra uterine~     salin flushing will be analyzed using a multiplex immunoassay for soluble regulators of~     implantation, namely Interleukin (IL)-1b, Tumor Necrosis Factor (TNF)-a,. In order to detect~     implantation predictors.~   "
54430|NCT02854501|"~     The current study included the singleton pregnancies (without history of previous risk~     factors), had their homocysteine measured as part of a serum-screening program in addition to~     uterine artery Doppler. Sensitivity, specificity, positive and negative predictive values,~     for development of preeclampsia and other adverse pregnancy outcomes were assessed as~     follows; (1) Homocysteine cutoff level at 6.3 µmol/l; (2) Bilateral notches on Doppler with a~     mean RI >0.5, all unilateral notches with a mean RI >0.6, in addition, absence of notches~     with a mean RI >0.7; (3) Doppler assessment combined with the homocysteine cutoff (6.3~     µmol/l).~   "
54431|NCT02854488|"~     The study is a global safety surveillance study of pregnancy outcomes in women who were~     exposed to ipilimumab during pregnancy and pediatric outcomes up to 5 years of age~   "
54432|NCT02854475|"~     The purpose of this study is to~      I. determine several skin parameters, for example natural moisturizing factor (NMF) and~     cholesterol, with Raman spectroscopy in vivo and~      II. compare the results with the corresponding cholesterol levels measured in venous blood.~   "
54433|NCT02854462|"~     The aim of this project is to test whether training parents to ask their children 'inference-~     eliciting' questions during book reading is effective in promoting story comprehension for~     4-year-olds from a range of socio-economic backgrounds.~   "
54434|NCT02854449|"~     This study will follow-up different immune cell populations in the blood before, during and~     after high dose radiation therapy which should give new information of the efficacy of Local~     Hypofractionated Radiotherapy and a rationale for adjuvant immunotherapy.~   "
54435|NCT02854436|"~     The purpose of this study is to assess the efficacy, safety, and pharmacokinetics of~     niraparib in men with metastatic castration resistant prostate cancer (mCRPC) and~     deoxyribonucleic acid (DNA) repair anomalies.~   "
54436|NCT02854423|"~     Both biodegradable polymer-based biolimus-eluting stents (BP-BES) and durable polymer-based~     everolimus-eluting stents (DP-EES) have been shown to improve long-term clinical outcomes as~     compared with early generation DES. BP-BES with DP-EES have been directly compared in 2~     randomized trials, showing no differences between the two devices in all-comer patients~     during long-term follow-up. It is unknown whether these results are consistent in real-world~     patients with diabetes mellitus during long-term follow-up. To evaluate the safety and~     efficacy profile of biodegradable polymer-coated biolimus-eluting stents (BP-BES) as compared~     to durable polymer-coated everolimus-eluting stents (DP-EES) in patients with diabetes~     mellitus during long-term follow-up.~      Consecutive diabetic patients undergoing percutaneous coronary interventions with BP-BES or~     DP-EES implantation were included in a multicenter registry between January 2007 and May~     2012. Long-term clinical outcomes between BP-BES and DP-EES will be compared using propensity~     score matching. The pre-specified primary endpoint is the occurrence of major cardiac adverse~     events (MACE) - a composite of all-cause death, myocardial infarction (MI) or target-vessel~     revascularization (TVR). Secondary endpoints are the individual components of the primary~     endpoint as well as definite stent thrombosis (ST).~   "
54437|NCT02854410|"~     The purpose of this study is to evaluate whether dietary nitrate supplementation could~     improve the salivary flow for nasopharyngeal carcinoma patients receiving concurrent~     chemo-radiation therapy.~   "
54438|NCT02854397|"~     In emergency room, this is crucial to diagnose an acute attack of hereditary angioedema (HAE)~     to quickly provide the efficient treatment. Currently, there is no specific biomarker for~     acute attack of bradykinin-mediated angioedema to help clinicians for patient care. However,~     previous works are carried out for that purpose. All the potential candidate biomarkers must~     be validated in prospective studies to estimate their specificity and sensitivity values, and~     to understand their potential utility in patient care.~      The main goal of this clinical trial is to estimate the diagnostic value of VE-cadherin in~     pediatric population, for the differential diagnosis between HAE crisis and angioedema~     resulting of mast cell activation crisis (the main differential diagnosis of HAE).~   "
54443|NCT02854332|"~     Prevalence of neuropathic pain raise to 6.9 % in the general population and can reach more~     than 58 % for patients that carry a lesion of the spinal cord. This pathological condition~     stays a major health problem, particularly as the efficacity of available treatments is~     currently limited. Only 30 to 40% of patients are relieved of more than 50% of their pain by~     a pharmacological approach.~      In case of failure, drug treatments or in addition of these ones, stimulation of the motor~     cortex is a therapeutic path proposed by Tsubokawa since the beginning of 1990s, but that~     found its place for neuropathic drug-resistant pain management only since a decade.~     Neurophysiologic mechanisms of the analgesic efficacity of the motor cortex stimulation are~     still little understood. This stimulation can be realised in a chronic and invasive way with~     implanted electrodes. This process allow a lasting relief for about half of operated persons,~     without the possibility to identify clinical selection criterion reliable for potentially~     responding patients for this technique.~      Recently, two electrophysiological non invasive techniques have been developed, allowing to~     get an analgesic stimulation of the motor cortex: the repetitive transcranial magnetic~     stimulation (rTMS) and the direct current transcranial magnetic stimulation (tDCS).~      The main goal of this study is to compare the importance of analgesic effect of tDCS in~     chronic drug-resistant neurophysiologic pains to the one get thanks to a reference method of~     stimulation non invasive of the motor cortex, the rTMS whose analgesic effect is already~     validated by data of the literature.~   "
54444|NCT02854319|"~     The objective of the REPRISE EDGE study is to confirm the acute performance and safety of the~     LOTUS Edge™ Valve System when used with the Lotus™ or iSleeve™ Introducer Set for~     transcatheter aortic valve implantation (TAVI) in symptomatic patients with severe calcific~     aortic stenosis who are considered high risk for surgical valve replacement.~   "
54445|NCT02854306|"~     Mindfulness is a common practice already widely used, that has shown benefits in terms of~     psychological and physical health. It is about learning or learn again to be self present and~     aware to the environment, across breathing, sensations, emotions and thought centering~     exercises, in the present moment without any judgement.~      The goal is to evaluate the efficacy of mindfulness versus an active control group in~     bariatric surgery.~   "
54446|NCT02854293|"~     Prospective, randomized, multicentre phase III study to evaluate the level and type of~     information requested by patients or families during a palliative care consultation after~     they have been given the Booklet-Question List (BQL).~   "
54447|NCT02854280|"~     Brain oxygenation is determined by the product of CaO2 and the cerebral blood flow (CBF), the~     modification of one or the other can affect the neuronal O2 availability.~      Besides the effect of the PaO2, the CBF is also regulated by the PaCO2. During effort in~     state of hypoxia, the drop of the PaO2 associated to a potential decrease of the PaCO2 and~     therefore of the CBF, can create an important dizziness between the demand and the supply of~     cerebral O2.~      It seems that hypoxia can trouble in a significant way the response of central neurons, just~     as the production of a motor cortex generated motor command.~      Studies suggest that exercise in severe hypoxia condition can constitute a necessary threat~     for brain oxygenation and the motor command, with the consequence a decrease of the exercise~     performance.~      This projects aim to study effects of hypoxia on the brain function for patients suffering~     from chronic respiratory disease. Neurophysiologic responses of the brain while resting or~     exercising, including drip and cerebral oxygenation, cortical excitation and motor command~     resulting for hypoxic subjects before and after a treatment to correct abnormalities of gaz~     in blood.~      The study will use a multidisciplinary and supplementary methodological approach : the~     near-infrared spectroscopy (NIRS) to appreciate the drip and cerebral oxygenation, CBF,~     neurostimulation procedures and electromyography (EMG) to appreciate the cortical~     excitability, measure the level of central activation and motor command.~      The goals of this study will be :~        -  Measure the drip and cerebral oxygenation, the cortical excitability, mechanisms of~          voluntary activation and central fatigue to the effort for the chronic hypoxemic patient~          compared to healthy control subjects.~        -  Analyse disruptions of locomotion parameters and posturographyc, in simple and double~          task, involving different levels of cerebral task.~        -  Analyse acute effects of an improvement of arterial oxygenation for patients suffering~          from chronic obstructive pulmonary disease (COPD) on drip and cerebral oxygenation,~          cortical excitability, mechanisms of voluntary activation and central fatigue.~        -  Evaluate effects of a treatment by continuous positive airway pressure (CPAP) for~          patients suffering from obstructive sleep apnea (OSA) with the same parameters.~   "
54448|NCT02854267|"~     A dedicated guide for physicians and organ procurement nurses meeting with the next of kin~     could be associated with a reduction in organ donation refusal rate, and in anxiety of~     professionals involved in such meetings~   "
54449|NCT02854254|"~     In decompensation of heart failure, it may occur low cardiac output. For patients in this~     situation, the use of inotropic may be necessary. Prolonged intravenous infusion of inotropic~     agents can lead to phlebitis in peripherally venous access. On the other hand, central venous~     access presents complications inherent in the procedure. The peripherally inserted central~     catheter (PICC) may be an option in this situation. The present research project is a~     randomized clinical trial to evaluate the incidence of phlebitis by using the PICC in~     comparison to the peripheral venous access. The criteria for inclusion are: advanced~     congestive heart failure, in use of intravenous inotropic; platelets > 50.000 mm3 and left~     ventricular ejection fraction (LVEF) < 0.45. Patients will be randomized to receive the PICC~     or keep the peripheral venous access. The main outcome will be the occurrence of phlebitis.~     The sample size will be of 40 patients for each group (PICC and control). The data will be~     analyzed by logistic regression. Will be considered significant P 0.05.~   "
54450|NCT02854241|"~     The purpose of this study is to investigate clinical feasibility of annual non-contrast~     magnetic resonance imaging for surveillance of hepatocellular carcinoma in high-risk group,~     in comparison with biannual ultrasonography.~   "
54451|NCT02854228|"~     The purpose of this study is to observe predictors of pituitary tumor recurrence and markers~     of persistent disease activity through computerized collection of comprehensive demographic,~     therapeutic, pathologic and outcome information on patients harboring pituitary mass lesions~     of all types.~   "
54452|NCT02854215|"~     The purpose of this study is to investigate the medico-economic impact of adherence to INCa~     (National Cancer Institute) guidelines in ovarian cancer surgery by assessment of outcome in~     cost per Quality Adjusted Life Years (QALY).~   "
54453|NCT02854202|"~     The investigators hypothesis is that eating whey protein in breakfast will reduce overall~     postprandial glycemia in individuals with type 2 diabetes (T2D).~   "
54465|NCT02854046|"~     Calciphylaxis, also called Calcific Uremic Arteriolopathy (CUA) is a lethal affection mostly~     affecting patient in end stage renal disease. The survival rate is described around 20 to 46%~     at one year.~      Clinical presentation is very painful skin lesions with ulceration mostly located on the~     trunk or thigh.~      Current knowledge about physiopathology, diagnostic practice and therapeutic is very limited.~      Actually there is no European study about calciphylaxis and risk factors, diagnostic practice~     and outcome factors.~   "
78950|NCT02533531|"~     This study is intended to assess the feasibility and usability of the 1 Lead Patch as a~     whole, on patients outside the hospital, in the out-patient setting.~   "
54454|NCT02854189|"~     The purpose of this study is to explore the effects of the Oxford unicompartmental knee~     arthroplasty on two groups of patients, namely one with genu recurvatum before the procedure~     and one without. Specifically, this study compare the number of occurrences of postoperative~     genu recurvatum and the postoperative hyperextension angles among the patients. Additionally,~     the knee scores, the pain scores, and the functional scores for the two groups of patients~     are compared.~      Materials and methods: This study prospectively followed 104 patients (114 knees) who had~     been treated with cemented minimally invasive surgery unicompartmental knee arthroplasty and~     had had a minimum of 24 months of follow-up. The patients were divided into two groups: those~     without preoperative genu recurvatum (85 patients; 94 knees) and those with preoperative genu~     recurvatum (19 patients; 20 knees). The incidence of the postoperative genu recurvatum, the~     postoperative hyperextension angles, the knee scores, the pain scores, and the functional~     scores were recorded and compared between two groups..~   "
54455|NCT02854176|"~     Worldwide, 9.6% of men and 18% of women aged over 60 years suffer from osteoarthritis (OA),~     most of which involve the knee. Within the OA patient population, 80% of the OA patients have~     limitations of movement, and 25% cannot perform the majority of their daily activities (WHO).~     Some of these symptoms contribute to arthrogenic muscle inhibition (AMI), a reflexive~     decrease in motor output to the muscles surrounding the affected joint.~      AMI is characterized by abnormal afferent information transmitted to the central nervous~     system, resulting in altered afferent feedback to the quadriceps motoneurons (MN) which in~     turn results in reduced excitability of that particular pool. The altered afferent input is~     suggested to stem from stimulation of mechanoreceptors, via joint effusion or excessive~     movements, nociceptors as a response to pain, or loss of joint receptors (Palmieri-Smith et~     al., 2009). Although the evidence concerning the role of the central nervous system is~     scarce, pre- and postsynaptic spinal mechanisms directly affecting alpha-MNs seem affected.~     Dysfunction of γ-loops also seems to be involved (Konishi et al., 2002). These mechanisms~     together result in AMI that manifests through aberrations in voluntary quadriceps torque,~     force control, and reflex excitability often measured by the H-reflex (Hopkins et al., 2000).~      Besides the evident role of motor efferents, sensory afferents also influence motor control~     (Gentilucci et al., 1997) and poor proprioceptive function is predictive of poor chair-stand~     performance (Sharma et al., 2003). Reduction of the sensory deficits could potentially~     increase motor function in knee OA. The present study aims to evaluate whether low-intensity~     peripheral electrical nerve stimulation, a form of increasing afferent input, could~     potentially improve OA patients' motor function. The most limiting factor in OA patients,~     however, is pain, experienced at rest and during movement. Although previous paradigms used~     high-frequency stimulation and the lack of physiological explanations concerning pain~     reductions after peripheral electrical nerve stimulation, it is possible that reductions in~     experienced pain are mediated by reduced analgesia, i.e., decreased excitability of~     nociceptive neurons.~   "
54456|NCT02854163|"~     The investigators propose an open label pragmatic clinical and laboratory study designed to~     investigate, in detail, the clinical and molecular effects of Interleukin 17 (IL-17) and~     inhibition of IL-17 with secukinumab, on neutrophil function in vitro and ex vivo.~      As secondary, exploratory objectives, the investigators will utilise the fact that~     secukinumab is to be administering to 20 patients with Psoriatic Arthritis (PsA) and~     investigate whether there is any relationship between vitamin D status and response to~     secukinumab, with respect to efficacy and adverse events. The results of this secondary~     exploratory analysis will inform the design of a larger, definitive study.~   "
54457|NCT02854150|"~     The main objective is to improve genetic counseling in patients with Spina Bifida, by the~     characterization of variants in new genes using high throughput sequencing either on a panel~     of targeted genes or on exome in families.~   "
54458|NCT02854137|"~     Evaluation of the human eye irritation potential of a test sunscreen formulation.~   "
54459|NCT02854124|"~     The objective of this project is to evaluate the presence of melanoma quiescent or initiating~     clonal cells in peritumoral healthy tissue displaying the same molecular signature than those~     of the tumor/metastasis and to correlate this presence to the prognostic value.~   "
54460|NCT02854111|"~     The overall global prevalence of type 2 diabetes mellitus (DM) is rising. Based on the latest~     Thai National Health Examination Survey, an estimated 3.2 million people had DM, of whom~     one-third was undiagnosed. The inexpensive oral glucose tolerance test (OGTT) is a more~     sensitive and reliable test of DM than fasting plasma glucose (FPG) or HbA1c, and is~     recommended for diagnosing DM and impaired glucose tolerance (IGT). Although the OGTT~     provides useful diagnostic information, poor patient tolerance of glucose solutions is~     inevitable.~   "
54461|NCT02854098|"~     Benign Hypermobility Joint Syndrome is a group of inherited abnormalities in the structure of~     connective tissues, manifested by disturbances in the proportion of collagen. The main~     symptoms of this syndrome include: laxity of joint capsules and ligaments, hypermobility of~     the joints, as well as numerous disturbances in the functioning of internal organs that~     contain connective tissue, including the gastrointestinal tract. Hypermobility of joints~     affects approximately 10% of the population of Western countries, is more common in small~     children and female. Modified Beighton scale is the basic scale for assessing hypermobility~     of joints. The scale (as assessed using the goniometer) is a reliable tool for the evaluation~     of excessive laxity of the connective tissue in children.~      Functional constipation is a very common condition, affecting approximately 3-5% of children~     and adolescents, with peak onset between 2 and 4 years of age. The etiology of this disorder~     is multifactorial, and till day it is still exactly unknown why some children develop~     constipation, while in others we can observe the correct scheme of defecation. Suspending~     stool enhances the retention of fecal masses, which subsequently causes painful defecation.~     Diagnosis is based on history, clinical symptoms and physical examination. Increased~     susceptibility of the wall of the distal gastrointestinal tract could explain the~     predisposition of some children to retain fecal masses and the development of constipation.~      Due to the unclear etiology of functional constipation, it seems reasonable to conduct a~     study assessing whether excessive laxity of connective tissue (assessed on the basis of the~     hypermobility of the joints) facilitates the accumulation of stool in the large intestine,~     and so is the one of the reasons leading to development of functional constipation in~     children.~   "
54462|NCT02854085|"~     The objective of this study is to determine the impact of Art Therapy and Music Reminiscence~     Activity on cognition in community living elderly with Mild Cognitive Impairment (DSM V: Mild~     Neurocognitive Disorder) using a randomized control design.~      Specifically, the structural cerebral changes that occur with the two interventions and the~     extent to which the therapies may reverse cognitive impairment and/or prevent further~     cognitive decline, will be determined.~      The hypothesis is that participants in both active intervention arms will perform better on~     neuropsychological tests of cognition and will show positive changes on functional imaging~     studies compared to controls who will not receive any intervention. Participants in the~     interventions will also have positive changes in blood biomarkers, enhanced psychological~     well-being and reductions in anxiety and depressive symptoms compared to the control group.~     No a priori hypotheses were developed as to whether Art Therapy or Music Reminiscence~     Activity is more effective as the comparison is exploratory.~   "
54463|NCT02854072|"~     To assess treatment of GV1001 concurrent with Gemcitabine/Capecitabine versus~     Gemcitabine/Capecitabine alone in locally advanced and metastatic pancreatic cancer patients.~   "
54464|NCT02854059|"~     The main purpose of this study is to evaluate safety and tolerability in patients diagnosed~     with asymptomatic antibody-mediated TTP with low ADAMTS13 activity after receiving single~     intravenous dose of IdeS.~   "
54466|NCT02854033|"~     Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging~     Initiative (ADNI) has been realized in informing the design of therapeutic trials in AD.~     ADNI3 continues the previously funded ADNI-1, ADNI-GO, and ADNI-2 studies that have been~     combined public/private collaborations between academia and industry to determine the~     relationships between the clinical, cognitive, imaging, genetic and biochemical biomarker~     characteristics of the entire spectrum of Alzheimer's disease (AD). The overall goal of the~     study is to continue to discover, optimize, standardize, and validate clinical trial measures~     and biomarkers used in AD research.~   "
54467|NCT02854020|"~     Since the number of air travelers, including the elderly and passengers with an underlying~     disease, is increasing every year, the number of inflight emergency patients is expected to~     increase as well. The investigators attempted to identify the incidence and types of inflight~     medical emergencies and analyze the first aid performed by cabin crew members or medical~     volunteers in flights by an Asian airline. The investigators also investigated the causes of~     inflight deaths and aircraft diversions.~   "
54468|NCT02854007|"~     A multicenter, prospective, observational cohort study with clinical, quality of life, and~     economic evaluation to ascertain the quality-adjusted life years (QALYs) gained by patients~     with ischemic heart disease revascularized with Absorb in standard clinical practice in~     Spain. A before-after comparative analysis will be performed, so that each patient will act~     as his/her own control.~   "
54469|NCT02853994|"~     The study is a prospective, non-randomized, multicenter, post-marketing surveillance study~     evaluating the CE-marked DEVOIR Sirolimus-Coated Coronary Balloon in 4 subgroups regarding~     device approved indications:~        -  In-stent restenosis lesions: either bare metal or drug eluting stent restenosis~        -  Bifurcation lesions (with drug-eluting stent in main branch and drug-coated balloon in~          side branch): treatment of lesion of all Medina types except (0,0,1) in native coronary~          arteries~        -  Small vessels: treatment of lesions ≤2.75 mm~        -  BMS implantation followed by DCB inflation~   "
54470|NCT02853981|"~     The purpose of this study is to determine whether clamp-crush technique for liver parenchymal~     transection is as safe as Harmonic scalpel device. outcomes will include: perioperative~     mortality, surgery-related complications, blood loss, amount of blood loss during~     hepatectomy, operating time, transection speed, markers of liver parenchymal injury and~     hospital stay.~   "
54471|NCT02853968|"~     The purpose of this study is to study stained Castleman's Disease lymph nodes and perform~     flow cytometry and cell culture experiments on Castleman Disease blood samples to determine~     which cellular pathways and immune cell types are driving the disease.~   "
54472|NCT02853955|"~     Percutaneous edge-to-edge repair of the mitral valve has been shown to be a safe and~     effective alternative treatment option for selected patients at high risk for cardiac~     surgery. Patients with recurrent mitral regurgitation after surgical mitral valve repair~     (sMVR) are per se at increased risk for another cardiac surgery. The purpose of this~     multicenter retrospective analysis of patients treated with a MitraClip® after sMVR, is to~     evaluate the effectiveness and durability of this minimally invasive treatment option in this~     subset of patients.~   "
54473|NCT02853942|"~     Main purpose：In the face of listening to nerve injury at early stage, utilizing autologous~     adipose stem cell transplantation in the treatment of makes the acceptance micro vascular~     decompression hemifacial spasm patients to nerve function to obtain a better recovery.~      Secondary purpose ：To clarify the efficacy of stem cells in the treatment of cranial nerve~     dysfunction, and to provide evidence for the treatment of other cranial nerve dysfunction.~      Cases in group：Appearing on the surface of microvascular decompression for hemifacial spasm~     to decrease neural electrophysiological index of patients research design：Single center,~     prospective, randomized, double-blind, controlled Observation index：Facial nerve clinical~     score, facial nerve muscle compound action potential, electrical measurement, cerebrospinal~     fluid index Evaluation of therapeutic effect：Facial nerve function evaluation~     (House-Brackmann classification, facial nerve function classification scale SFGS), facial~     nerve electrophysiology evaluation (facial nerve muscle compound action potential), electric~     measurement Safety evaluation：Clear evaluation of hemifacial spasm and micro vascular~     decompression were listening to nerve in intracranial segment wrapped around the autologous~     fat stem cell therapy overall safety and evaluation methods including adverse events,~     laboratory tests, vital signs, electrocardiogram.~   "
54474|NCT02853929|"~     The purpose of this study is to assess the immunogenicity and safety of the Infanrix hexa~     booster dose given at 11-18 months of age to infants who received primary vaccination at 6-14~     weeks. All infants in this booster study were born to pregnant women who participated in the~     study 116945 [DTPA (BOOSTRIX)-047] and having received the full primary vaccination series as~     per protocol requirement in study 201330 [DTPA (BOOSTRIX)-048.~   "
54475|NCT02853916|"~     The objectives of this trial are to confirm efficacy in human of a brown seaweed powder and~     explore dose-response relationship by comparing two different doses.~      The primary endpoint is incremental area under the curve (iAUC, mmol*min/L) for blood~     glucose.~   "
54476|NCT02853903|"~     The aim of this study is the efficacy of autogenic and allogenic natural killer (NK)~     immunotherapy on recurrent solid tumors.~   "
54477|NCT02853890|"~     Obstetric analgesia is a requirement of our times. The different applicable methods vary in~     effectiveness. The essential part is represented by epidural analgesia which remains one of~     the most effective methods. It is important to know other methods to respond to all requests.~     The applications of these methods, patient satisfaction and psychic experience, complications~     or incidents remain poorly or partially evaluated in France.~      The main objective is to describe the different techniques of anesthesia/analgesia actually~     used in France for the management of pain during vaginal deliveries and cesarean sections on~     a representative sample of all maternity hospitals at a given time(7 days per maternity~     hospital, 63 maternity hospitals (levels I,II,III), so about 2500 births).~      Secondary objectives will be multiple :~        -  Describe the results of analgesic methods on the physical pain of patients during labor~          by a global visual analog scale~        -  Describe the feeling of pregnant women relative to the different anesthesic and~          analgesic techniques, by an analysis of the questionnaire responses~        -  Describe the frequency of adverse events of birth~   "
54492|NCT02853695|"~     By means of a questionnaire the investigators will study the implementation of hysteroscopy~     in Flanders and the Netherlands~   "
54478|NCT02853877|"~     This study will evaluate the effectiveness of financial incentives and messaging tailored to~     individual goals and aspirations to promote and sustain weight loss. This is a 2-arm~     randomized controlled trial that will recruit eligible employees at a large university to~     participate in a 3-month weight loss program, followed by a 3-month follow-up period. The~     primary outcome will be change in autonomous motivation for weight loss.~      The study hypothesis is that intervention group participants will have a greater increase in~     autonomous motivation for weight loss than participants in the control group at 12 weeks.~   "
54479|NCT02853864|"~     The purpose of this study is to determine the effect of gender on pharmacodynamic interaction~     of propofol and dexmedetomidine, exploring the effect of gender on propofol unconsciousness~     median effective concentration with different dose dexmedetomidine.~   "
54480|NCT02853851|"~     This study aims to construct and validate an international professional perceived stress~     scale specific to intensive care units: the PS-ICU Scale (Perceived Stressors in Intensive~     Care Units).~   "
54481|NCT02853838|"~     The purpose of this research is to determine the effect of prolonged slow expiration~     techniques, provoked coughing and standard therapy compared to chest wall manual vibration~     and standard therapy in infants between 0 and 12 months old with confirmed diagnosis of acute~     bronchiolitis SRV (+). The effect will be measured on respiratory insufficiency and use of~     supplementary oxygen.~   "
54482|NCT02853825|"~     Every program element was designed to ensure that all children in the areas served will live~     in stable, happy, healthy family situations. The JFCS Healthy Families/Healthy Children~     program will provide relationship skill enhancement interventions. All program participants~     in the intervention group will have acces to: parenting skill enhancement interventions,~     employment readiness and/or situation enhancement, as well as financial knowledge and/or~     situation enhancement.~   "
54483|NCT02853812|"~     The proposed research is to identify the brain areas activated or deactivated by tinnitus in~     humans. The identification of these areas is expected to be able to treat tinnitus refractory~     to traditional therapies by methods of brain stimulation. Furthermore, this technique would~     be very useful to verify the effectiveness of any treatment to relieve tinnitus.~      The brain activation measured during fMRI will be performed in a position of rest, after~     inhibition of tinnitus, and after application of a sound that does not inhibit tinnitus. This~     comparison will identify specific brain areas activated or deactivated by tinnitus.~   "
54484|NCT02853799|"~     Continuous enteral feeding is the most common type of nutrition used in critically ill~     patients despite being non-physiologic, as all mammalian alimentary tracts have been designed~     for intermittent ingestion of nutrients. The small numbers of randomized controlled studies~     that have compared intermittent gastric feeds (IGF) to continuous gastric feeds (CGF) in~     intensive care units have demonstrated that IGF is safe, feasible and have the shorter time~     to goal nutrition. Studies of healthy adults have also demonstrated that the mean glucose~     concentration (MGC) is lowered when bolus enteral feedings are used instead of continuous~     feeds; these changes in glucose-insulin metrics might be beneficial to a critically ill~     patient population where stress hyperglycemia is common. This study will compare the effects~     of CGF and IGF in a critically ill medical patient population. Glucose-insulin dynamics for~     each type of enteral feed will be analyzed by performing a randomized crossover study to~     compare the effects of CGF and IGF on MGC, total insulin infused, glucose variability (GV),~     episodes of hypoglycemia and maximum glucose concentration values.~   "
54485|NCT02853786|"~     The Language Environment Analysis (LENA) system is a specific tool for the language~     environment analysis. Children aged from 18 months to 6 years old, with cochlear implants~     (CIs), wear an electronic device during a day and their language interactions are registered.~     Then the investigators can analyze with a specific software four different parameters (adult~     words, conversational turns, child vocalizations and media exposure) and compare them to the~     language ability of the children assessed by a speech therapist. With the results, the speech~     therapist can advise the parents how to improve the language environment to help their~     children with CIs for their language development. Parents are encouraged to follow these~     advices at home during few months (5 months +/-1 month). Then there is a new registration of~     the LENA device and another language assessment are performed, to see if there is any~     improvement. The investigators also measure the family participation.~      Hypothesis : There is an influence of the language environment measured by the LENA system on~     language development in children with cochlear implants.~   "
54486|NCT02853773|"~     This study aims at investigating the acute influence of artificially sweetened beverages~     consumption (as compared with sugar-sweetened beverages and water consumption) on brain~     responses to the viewing of food images, on physiological responses (gut-derived hormones and~     lipid metabolites) and on the food intake behavior.~   "
54487|NCT02853760|"~     Using a within-subject design, 42 healthy participants were randomly exposed to three~     different conditions: outdoor mountain hiking, indoor treadmill walking, and sedentary~     control situation (3.5 hours each). Measures included the Feeling Scale, Felt Arousal Scale~     and a Mood Survey Scale. Univariate ANOVAs were used to analyse differences between the~     conditions.~   "
54488|NCT02853747|"~     The project is designed as a large scale, cross-sectional study. The aim of the study is to~     investigate the association of micro- and macrovascular function with physical fitness and~     body composition in primary school children.~   "
54489|NCT02853734|"~     The research aims to compare the inflammatory status of visceral adipose tissue from obese~     patients depending on the presence and severity of periodontitis, in order to establish a~     potential causal link between the severity of the bacterial contamination and insulin~     resistance.~   "
54490|NCT02853721|"~     150 patients divided into two groups.The experimental group was submitted at the assay of~     iPTH six hours after surgery whilst the control group was submitted to a daily assay of serum~     calcium and phosphorus.~   "
54491|NCT02853708|"~     The sequence type 131 (ST131) is a predominant lineage among extraintestinal pathogenic~     Escherichia coli. It plays a major role in the worldwide dissemination of E. coli that~     produce extended-spectrum beta-lactamase (ESBL). The aim of this study was to describe the~     epidemiology of ESBL producing ST131clonal group in our university hospital. All patients~     with an infection due to ESBL E. coli will be prospectively included for a 2-year period.~     ST131 isolates will be identified and risk factors associated to ST131 will be determined in~     comparison to non-ST131 ESBL E. coli.~   "
54493|NCT02853682|"~     The glycocalyx is a layer of proteins and complex sugars covering the endothelium of vessels.~     Its role as capillary filtration control is important. In case of alteration of the~     glycocalyx, experimental models and some clinical studies show an increased capillary leak~     responsible for interstitial edema. The analysis of glycocalyx in routine care is important~     to guide volume expansion. Indeed, the literature provides evidence about the poor prognosis~     of excess water and its impact on organ. This analysis challenge is to justify filling~     solution of choice according to the characteristic of this capillary leakage.~   "
54494|NCT02853669|"~     Adductor canal block (ACB), Saphenous nerve block, which is a block of a purely sensory nerve~     which shares in nerve supply of knee joint has a hypothetical advantage of better pain~     management with less motor affection. Also, it has a clear anatomical landmark that will~     increase the success rate (femoral artery) (*).On the other hand, being a branch of the~     femoral nerve and far distal from the plexus, this can decrease the blocking effectiveness.~     Likewise, the great variation of the knee nerve supply.~      This prospective double-blinded randomized controlled trial is comparing ultrasound guided~     adductor canal block (ACB) versus ultrasound-guided lumbar plexus block (LPB) in patients~     undergoing total knee arthroplasty aiming at decreasing post-operative pain, helping in early~     mobilization and better physiotherapy.~      This study hypothesizes that ACB, compared with LPB, will exhibit less motor, weakness, fewer~     opioids consumption with the same or better pain score.~   "
54495|NCT02853656|"~     Preterm birth (babies being born before 34 weeks pregnancy) occurs in approximately 11% of~     pregnancies; preterm birth can lead to complications for the baby.~      When mothers are identified as being at risk of going into preterm birth (giving birth within~     the next 14 days) there are several treatments available that may help reduce the likelihood~     of complications for the baby. These treatments usually need to be started within 24 hours so~     it is very important that diagnosing preterm labour in not only fast but accurate.~      There are several methods commonly used within hospitals for diagnosing mothers who may be at~     risk of going into preterm labour. The two most common ones are foetal fibronectin (fFN) and~     phosphorylated insulin-like growth factor binding protein 1 (phIGFBP-1).~      The purpose of this study is to compare the two tests to see which is more accurate at~     predicting preterm birth.~   "
54496|NCT02853643|"~     The purpose of this study is to evaluate the safety and tolerability, and determine the blood~     levels (pharmacokinetics), in both a fed and fasted condition, of a single dose of ASN002.~     Healthy volunteers will be participants in the study.~   "
54497|NCT02853630|"~     This study is a multicentre, randomized, open label on comparison of pancreatic beta cell~     recovery and preservation of Vildagliptin 100mg daily and Metformin (1000 - 2500mg) daily for~     96 weeks in 203 patients with type 2 diabetes that will be conducted in four centers in~     Chennai. The primary outcome measures will be to compare the effects of Vildagliptin versus~     Metformin on Pancreatic beta cell function in type 2 diabetic patients as measure by Insulin~     secretion rate (ISR) relative to glucose0-2hr (pmol/min/m2/mmol/L). The secondary outcomes~     will be effect of Vildagliptin versus Metformin based treatment on glycaemic variables in~     terms of Percent HbA1c reduction, C-peptide responses, Insulin to glucose ratios, Reduction~     in fasting plasma glucose (FPG), 2hr postprandial glucose (PPG) from baseline, Improvement in~     insulin sensitivity, Improvement in oral disposition index, Percentage of patients reaching~     the glycemic target of (i) HbA1c ≤ 6.5% and (ii)HbA1c ≤ 7.0%, in the overall study population~     and General safety in terms of occurrence of adverse events~   "
54498|NCT02853617|"~     AV0328 is a novel vaccine candidate intended to raise antibodies to the glucosamine backbone~     of naturally occurring Poly N-acetyl glucosamine (PNAG), a capsular polysaccharide expressed~     on the surface of a wide array of microbes.~      AV-101-16: A single and repeat dose, dose-escalation phase I/II study to evaluate the safety~     of intramuscularly administered AV0328. Approximately 16 subjects will be enrolled at a~     single U.S. center, based on 4 subjects per dose group. The study will consist of 3 parts:~     Part 1 will be a single dose, dose escalation study; Part 2 will assess the effect of a~     second dose of AV0328; Part 3 will assess the ability of a booster injection of AV0328 at~     Month 6 to restore protective titers against N. meningitidis B16B6 bacteria.~   "
54499|NCT02853604|"~     High-risk locally advanced carcinoma of the cervix (HRLACC) following concurrent chemotherapy~     and radiation therapy. This is a group of patients with a significant unmet need. The~     estimated probability of disease recurrence or death within 4 years of diagnosis is 50% and~     the prognosis is very grave for those who experience a recurrence.~      The purpose of the study is to compare the disease free survival (DFS) of ADXS11-001 to~     placebo administered following CCRT with curative intent in subjects with HRLACC.~   "
54500|NCT02853591|"~     This study seeks to evaluate post-operative patient pain and quality of life, and~     intra-operative hemodynamic status and changes in inflammatory markers, with use of a~     pressure-barrier insufflator and conventional insufflator at high and low pneumoperitoneum~     pressure settings.~   "
54501|NCT02853578|"~     National clinical trial, phase III, multicenter, single-arm, efficacy study, 80 participants~     of both sexes, aged equal or more than 12 and less than 65 years. The group will use Busonid®~     (budesonide 200mcg and 400mcg) one application (inhalation) of 200 mcg every 12 hours (400mcg~     / day). During follow-up visits if the participant has not shown an increase in forced~     expiratory volume in one second greater than 12% and greater than 0,20L or 200ml in~     spirometry compared with baseline visit, will increase the dose to 800 mcg / day (2x 400 mcg~     day).~      The study aims to revalidate by the National Health Surveillance Agency (ANVISA) the~     registration of the drug Busonid® which there is a vast scientific literature on the~     pre-clinical and clinical evidence that the efficacy and safety of budesonide. Thus, outlined~     is a single-arm study, which is applied to the study of the group of participants the same~     intervention for a certain period and the participants are evaluated for response.~   "
54502|NCT02853565|"~     To evaluate CAN008 safety, tolerability, and pharmacokinetics (PK) of CAN008 when~     administered concurrent Plus Concomitant Temozolomide During and After Radiation Therapy in~     Patients with Newly Diagnosed Glioblastoma Multiforme.~   "
54503|NCT02853552|"~     The overall study purpose is to evaluate the safety, feasibility and acceptability of advance~     distribution of misoprostol to be used as 'first aid treatment' administered by the woman~     herself or her family to help treat excessive bleeding in home births.~   "
79693|NCT02523820|"~     The purpose of this study is to evaluate the efficacy and adverse effect of nebulized~     corticosteroid to prevent post-extubation stridor in children.~   "
54506|NCT02853513|"~     The scientific approach of this project proposes to build a cohort of psychological~     injuries post-attack of 13 November 2015. This is called patients involved, ie patients~     who directly witnessed the events and having the most either came under automatic gunfire or~     were close to an explosion, whether or not physically injured.~      The main objective is to define and validate a model of transition from acute stress disorder~     (ASD) to posttraumatic stress disorder (PTSD) for better detection of the risk of unfavorable~     and thus better patient supported.~      The first step is to determine independent risk factors found in analytic prospective cohort~     study.~      Bayesian models are well suited to exercise because they can integrate (i) the context~     related to the patient, (ii) the context related to the trauma itself, and (iii) the~     immediate reactions and long-term to the latter . They are particularly suited to~     understanding the brain disordered by saying down information (prior probability) wrong by~     improper memory of the traumatic event. The confrontation of these descending information and~     perceived bottom-information could be partly responsible for the symptoms of PTSD.~      Once validated, the model will characterize the individual level the most at risk of~     unfavorable patients (calculating a probability of developing PTSD) and to assess the~     epidemiological impact on long-term cohort of event considered.~      These determinations are necessary prerequisites to optimize the means of support for these~     current and future casualties.~      The investigators main objective is to define a Bayesian model describing a resilient~     functioning facing a trauma which also allows to describe a possible evolution of the ASD to~     PTSD by an error.~      The state of PTSD or not will be determined by the PCL-S scale.~   "
54507|NCT02853500|"~     This research study is studying the Surefire Infusion System (Surefire) for increasing~     delivery of chemotherapeutic agents delivered trans-arterially to intermediate stage~     Hepatocellular Carcinoma (HCC) (Barcelona Clinic Liver Cancer (BCLC) class B; locally~     advanced, liver restricted disease patients.~      The names of the study interventions involved in this study are:~      -Trans-arterial chemoembolization (TACE) with or without the utilization of Surefire~   "
54508|NCT02853487|"~     The aim is to investigate circadian rhythm in episodic cluster headache using actigraphy.~   "
54509|NCT02853474|"~     This prospective, randomized, open-label and multicenter phase III study is aimed to estimate~     the survival benefit of Early Palliative Care (EPC) combined with standard oncology care~     including first-line chemotherapy (experimental arm) over standard oncology care only~     (standard arm), in patients with metastatic upper gastrointestinal cancers (gastric cancer,~     pancreatic cancer, biliary tract cancers).~   "
54510|NCT02853461|"~     In this study the investigators sonicate the bearing components of the explanted hip~     prosthesis which allows highly sensitive detection of in vivo biofilms (qualitatively and~     quantitatively). The hip prosthesis bearing components are composed from different material.~     The purpose of this study is to analyse the resistance against biofilm adhesion of ceramic,~     metal and polyethylene prosthesis components through microbiologic analysis of sonicates.~   "
54511|NCT02853448|"~     There are many instances where there is no access to a centrifuge (Emergency wards, EMT~     truck, battle field, etc.) or when a result is needed immediately (myocardial infarction); a~     new collection tube which could separate serum and plasma from whole blood immediately upon,~     if not during, collection, would be extremely beneficial. Such a new tube could save time and~     cost by eliminating centrifugation steps that are currently required to obtain serum and~     plasma.~   "
54512|NCT02853435|"~     This study is divided in 2 parts. Part 1a is being conducted to evaluate the safety,~     tolerability, and relative bioavailability of the 2 free base tablet formulations (related~     compound [RC] and high shear wet granulation [HSWG]) compared to the reference capsule~     formulation under fasted conditions. This is a 3-period; cross-over study that will guide~     which gepotidacin formulation will be used for future studies. Following review of~     pharmacokinetic (PK) and safety data in Part 1a, a decision will be made whether to proceed~     with Parts 1b and 2.~      Part 1b is a 2-period, cross-over study and will assess the effect of food on the PK of the~     selected gepotidacin tablet formulation from Part 1a. In Part 2, the PK of the selected~     gepotidacin tablet formulation from Part 1a in Japanese (2a) and Chinese (2b) subjects will~     be evaluated under fasted conditions.~      The duration of the study (from Screening to the Follow-up visit) will be approximately 44~     days (Part 1a), 41 days (Part 1b) and 38 days (Part 2a and 2b each), respectively. The~     approximate number of subjects enrolled in Part 1a will be 27 (9 subjects in each of the 3~     treatment sequences), 16 in Part 1b (8 subjects in each of the 2 treatment sequences) and 12~     Japanese and 12 Chinese subjects in Part 2a and 2b, respectively.~   "
54513|NCT02853422|"~     The purpose of this study is to evaluate the utility of the QLQ-GINET21 in making clinical~     and therapeutic decisions.~   "
54514|NCT02853409|"~     The purpose of this study is to evaluate possible changes in quality of life related to~     health (HRQL) in locally advanced and metastatic prostate cancer patients, after one year of~     follow-up.~   "
54515|NCT02853396|"~     Stigma is a significant concern for those who experience psychosis. People with psychosis are~     the most stigmatised group of all mental health difficulties. There is a lack of research~     examining the effectiveness of psychological therapies for people who experience psychosis~     who are also experiencing negative impacts of stigma. To date, all studies examining stigma~     therapies have been conducted with outpatients and no support have been developed for~     inpatients. The aim of this study to conduct a pilot randomised controlled trial of a brief~     therapy (based on cognitive behavioural therapy)to help participants cope with stigma. It~     will be compared to a educational control intervention. Both therapies will last~     approximately two hours and be conducted in one or two sessions by the principal investigator~     (clinical psychologist). Participants will be given a number of questionnaires assessing a~     number of outcomes such as impacts of stigma, depression, recovery, and self-esteem.~     Participants will be assessed on these measure prior to the therapy, post therapy and at~     follow-up.~   "
54516|NCT02853383|"~     The purpose of this study is to determine COPD prevalence among patients registered in the~     healthcare system of Moscow (under outpatient surveillance at polyclinic institutions of~     Moscow).~      To describe the clinical profile of COPD patient who is under outpatient surveillance at~     polyclinic institutions of Moscow (including demographic data (age, gender, ethnicity,~     occupation), smoking status, disease duration, disease severity grade, distribution by~     disease phenotype, disease exacerbation rate in the setting of real-life clinical practice).~   "
54517|NCT02853370|"~     Splenic Marginal Zone Lymphoma (SMZL) is a well-defined low-grade B-cell lymphoma,considered~     as a rare neoplasm accounting for about 2% of all non-Hodgkin's lymphomas (NHL) and~     represents for most cases of otherwise unclassifiable chronic lymphoid B-cell cluster of~     differentiation antigen 5 (CD5)-lymphoproliferative disorders. SMZL is characterized by an~     almost exclusive involvement of the spleen and bone marrow and in about 25% of cases the~     disease pursues an aggressive course and most patients die of lymphoma progression within 3-4~     years.~      Retrospective studies have indicated that purine analogous achieved very high response rates~     in both naïve and pre-treated patients. Moreover, the introduction of the anti-cluster of~     differentiation antigen 20 (CD20) humanized antibody rituximab, either used alone or in~     combination with chemotherapy has been reported to be very effective in producing a rapid~     clearance of neoplastic cells.~   "
54518|NCT02853357|"~     The purpose of this study is to determine the short-term effects of thoracic spine thrust~     manipulation on participants with low back pain. Participants in this study will be~     randomized to receive either the lower thoracic spinal manipulation and a standard set of~     exercises, or a sham manipulation and the same standard set of exercises. It is hypothesized~     that thoracic manipulation when combined with core strengthening exercises will have positive~     short term improvements in pain and function for patients with LBP as compared to a sham~     manipulation combined with core strengthening exercises.~   "
54519|NCT02853344|"~     The purpose of this study is to assess the safety and efficacy of monotherapy pembrolizumab~     (MK-3475) in participants with renal cell carcinoma (RCC). There will be two cohorts in this~     study: Cohort A will consist of participants with clear cell (cc) RCC and Cohort B will~     consist of participants with non-clear cell (ncc) RCC.~   "
54520|NCT02853331|"~     The purpose of this study is to evaluate the efficacy and safety of pembrolizumab (MK-3475)~     in combination with axitinib versus sunitinib monotherapy as a first-line treatment for~     participants with advanced/metastatic renal cell carcinoma (mRCC).~      The primary hypotheses of this study are: 1) The combination therapy of pembrolizumab plus~     axitinib is superior to sunitinib monotherapy with respect to Progression-Free Survival (PFS)~     as assessed by blinded independent central imaging review per Response Evaluation Criteria in~     Solid Tumors version 1.1 (RECIST 1.1) and 2) the combination therapy of pembrolizumab plus~     axitinib is superior to sunitinib monotherapy with respect to Overall Survival (OS).~   "
54521|NCT02853318|"~     This phase II trial studies the combination of pembrolizumab, bevacizumab, and low dose oral~     cyclophosphamide in treating patients with recurrent ovarian, fallopian tube, or primary~     peritoneal cancer. Monoclonal antibodies, such as pembrolizumab and bevacizumab, may block~     tumor growth in different ways such as boosting your own immune system to find, recognize and~     kill tumor cells as well as by blocking the growth of new blood vessels necessary for tumor~     growth and nutrition. Drugs used in chemotherapy, such as low dose oral cyclophosphamide,~     work in different ways to stop the growth of tumor cells, either by killing the cells, as~     well as by further enhancing your own body's immune response against cancer cells. As these~     three drugs have all been shown to improve the immune response against cancer cells giving~     pembrolizumab, bevacizumab, and cyclophosphamide together may work better in treating~     patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer.~   "
54522|NCT02853305|"~     The purpose of this study is to determine the efficacy and safety of pembrolizumab (MK-3475)~     with or without chemotherapy versus chemotherapy alone in participants with advanced or~     metastatic urothelial carcinoma (bladder cancer).~      The primary hypotheses are that pembrolizumab plus chemotherapy is superior to chemotherapy~     alone with respect to Progression-free Survival (PFS) and Overall Survival (OS) in~     participants with programmed cell death ligand 1 (PD-L1) positive tumors (Combined Positive~     Score [CPS] ≥10%) and in all participants (includes those participants with PD-L1 positive~     tumors and those with PD-L1 negative tumors [CPS <10%]).~   "
54523|NCT02853292|"~     Intravenous high-dose amoxicillin is a frequently prescribed antibiotic in intensive care~     units and infectious disease departments, in such indications as meningitis, endocarditis,~     listeriosis, or documented susceptible osteo-articular infections.~      Among possible side effects is the occurrence of amoxicillin crystalluria. Its incidence is~     unknown. It is deemed uncommon but literature is poor and its incidence is probably~     under-estimated. It can be complicated with hematuria or acute renal failure and may require~     renal replacement therapy. measures that can limit the impact of this nephrology~     crystalluria.~      Since the beginning of 2014, because of the occurrence of a case of macroscopic crystalluria~     in our unit and a pharmacovigilance alert, it has been decided to search systematically for~     amoxicillin crystalluria in several centers of the north-east of France. The investigators~     propose to study these patients, through an observational study of a multicenter longitudinal~     cohort, to assess the incidence of amoxicillin crystalluria during high dose intravenous~     amoxicillin treatment.~   "
54524|NCT02853279|"~     One hundred participants from a combination of (a) local advertisements and/or (b) those~     whose details are held on a research database (of previous volunteers indicating willingness~     to be contacted about future studies) will be sought to volunteer for this study. Written~     informed consent will be gained following greater than 48 hours for the purpose of reading~     the Participant Information sheets. The study will then involve two stages (i) recruiting~     participants for a cross sectional analysis of the relationship between physical activity~     levels and cardiovascular and cognitive function, and (ii) a longer exercise training study~     in a subsample of these volunteers (i.e. participants who volunteer to exercise train).~     Participants for stage 1 will then visit the laboratory in the University on three occasions~     (over a three week period) to be assessed for body composition, exercise tolerance, current~     physical activity levels, cognitive function and arterial and cardiac health. Each visit will~     last for 60 - 90 minutes. Participants will then be provided with an accelerometer to wear~     for a period of one week in order to assess movement counts and sedentary behaviour. Stage 2~     will include only those participants who have volunteered for the exercise training component~     (approx 60). These participants will then be randomly divided into two groups. Both groups~     will exercise three times per week for 12 weeks duration. Group 1 will exercise in a~     traditional manner at a moderate intensity, whilst the second group will exercise at a heavy~     intensity but in short bursts. Both groups will complete the same amount of work but in two~     differing modes. Both groups will attend the laboratory twice per week for supervised~     exercise sessions and also perform one home based 30 minute brisk walk per week. All~     participants will be re-examined at 12 weeks.~   "
54534|NCT02853149|"~     This study determines in people with chronic SCI the health and functional impact and user~     acceptance and satisfaction - of a 6-month comprehensive Lifestyle Intervention; the impact~     and user acceptance/satisfaction of a Complementary Caregiver Curriculum (CCC) on SCI~     caregiver health and function and whether the complementary caregiver curriculum (CCC)~     enhances health and functional benefits obtained by the SCI dyadic partner enrolled in the LI~     program.~   "
54535|NCT02853136|"~     To investigate the influence of fluvoxamine on the pharmacokinetics of BI 409306~   "
54525|NCT02853266|"~     Kawasaki disease (KD) is an acute systemic vasculitic syndrome with coronary tropism. It has~     been reported worldwide, but it is ten times more common in Asian population. It is the~     second vasculitis of the child by its frequency after rheumatoid purpura. It occurs in 80% of~     cases between 1 and 5 years, with a maximal incidence around the age of 12 months.~      KD is not well understood and the cause is yet unknown. It may be an autoimmune disorder. The~     problem affects the mucous membranes, lymph nodes, walls of the blood vessels, and the~     heart.The clinical picture of KD associate a persistent fever and an antipyretics resistance~     with mucocutaneous signs and bulky cervical lymphadenopathy usually unilateral.~      There is currently no vaccine available against Kawasaki disease so it is extremely important~     to be able to recognize symptoms before they set in and become too severe.~      Chagas disease (CD) is caused by the parasite Trypanosoma cruzi. Acute CD occurs immediately~     after infection, may last up to a few weeks or months. Infection may be mild or asymptomatic.~     There may be fever or swelling around the site of inoculation, and acute infection may result~     in severe inflammation of the heart muscle. The notion that the pathology of CD has an~     autoimmune component was initially based on the finding of circulating antibodies binding~     heart tissue antigens in patients chronically infected with T. cruzi.~      A recent study reports a possible antigen (non-cruzi-related antibody NCRA) mimicry~     characterized by a serological reactivity to a well-defined T. cruzi antigen in blood samples~     from individuals not exposed to the parasite. The measured seroprevalence of such~     cross-reactivity is in favor of a highly prevalent immunogen acquired in childhood.~      There are similarities in mechanism of CD and KD: it could be interesting to explore the~     presence of NCRA in blood samples from adults with a history of KD.~      The objective of the study is the measurement of the biomarker NCRA in serum in adults with a~     history of KD compare to a control population. This measurement and the prevalence may permit~     to associate the NCRA to a possible pathogenic agent.~   "
54526|NCT02853253|"~     SMOF is a large double blind placebo-controlled randomized clinical trial aiming to compare~     the rate of bronchopulmonary dysplasia (BPD) at 36 weeks corrected age in premature infants <~     29 weeks and / or with birth weight < 1000 g receiving either SMOFlipid® or Medialipide® 20%.~     This study will offer new information for optimizing the management of preterms requiring~     parenteral nutrition. The investigators hypothesis is that the composition of SMOFlipid may~     decrease lipid peroxidation and oxidative stress in preterms, resulting in a lower incidence~     of BPD.~   "
54527|NCT02853240|"~     Cerebral palsy (CP) is a group of non-progressive motor dysfunction but often changing,~     secondary to injury or brain abnormalities that occur in early stages of development. In~     children with CP, the brain injury lead to a delayed motor development in the first weeks,~     associated with muscular spasticity. Drug treatments include oral treatments (baclofen and~     tizanidine) and injectable treatments like Botox (intramuscular injection) and neurolysis~     with alcohol or phenol (local injection into the nerve).~      Regarding botulinum toxin, there is no study questioning its effectiveness. However, no~     publication on the pathophysiology of human muscle of the CP child after toxin injection was~     found. The action of the toxin on the neuromuscular junction (NMJ) and muscle structure is~     unknown in children with CP.~      The primary objective of this study is to describe structural abnormalities of the CP child's~     muscle following multiple toxin injections in terms of NMJ fragmentation and axonal~     sprouting.~      Secondary objectives:~      To evaluate the relationship between:~        -  The severity of the motor impairment and muscle structural abnormalities.~        -  The clinical measure of spasticity and muscle structural abnormalities.~        -  To compare the structure spastic muscles with toxin injections and spastic muscle~          without toxin injections~      For muscles with multiple toxin injections, assessing the relationship between :~        -  The number of toxin injections and muscle structural abnormalities.~        -  The date of the first injection and muscle structural abnormalities.~        -  The total dose of injected toxin in the muscle and its structural abnormalities.~        -  The nature of the product injected in the muscle and its structural abnormalities.~      This innovative study will improve the knowledge on the effects of long-term botulinum toxin~     injections on the muscle (and therefore its safety in usual care), on the spastic muscle NMJ~     of CP children, on the pathophysiology of the CP child's muscle.~      All the visits all acts will be performed according to usual patient follow-up. Only a biopsy~     will be performed in addition, taken from an injected muscle during a planned operation. A~     biopsy may also be performed on a muscle without toxin injection if the act is made possible~     by the planned surgery. No biopsy will be made on a muscle that would not require surgery.~   "
54528|NCT02853227|"~     This paper will present a specific tool for evaluation of cosmetic results after breast~     conserving surgery (BCS) and secondary breast reconstruction with free DIEP-flap.~     Introduction of a breast score system using digital photography seems to be a reliable tool~     for estimation of cosmetic results after breast surgery. The method has been employed on a~     specific group of 346 consecutive patients operated for breast cancer with breast conserving~     surgery. For the purpose of this study breast score system was tested on patients with free~     flap breast reconstruction (DIEP flap).~   "
54529|NCT02853214|"~     Multiple Myeloma (MM) is a malignant proliferation of monoclonal plasma cells. Myeloma~     accounts for almost 14% of all hematologic cancers and is essentially incurable. Myeloma~     commonly evolves from a precursor disease, Monoclonal gammopathy of undetermined significance~     (MGUS). Despite intensive study, the etiology of MGUS and myeloma are unknown and no~     lifestyle or environmental exposure factors have been identified that are consistently linked~     to increased risk of MM, MGUS or the transition between the two.~      The overall goal is to identify risk genes for dysglobulinemia, and more specifically~     Multiple Myeloma. This will involve the conservation of cells in a bank and genetic~     sequencing on samples obtained from families with at least two cases of dysglobulinemia.~     Material used for sequencing is likely to include fresh peripheral blood cells or~     lymphoblastoid lines established from peripheral blood lymphocytes of patients.~   "
54530|NCT02853201|"~     Mechanical ventilation is a life-saving treatment for critically ill patients who are unable~     to breathe on their own. At the time of recovery, separation from the ventilator is performed~     without difficulty for the majority of patients. However, approximately 15% of patients~     experience extubation failure, i.e. they are re-intubated after extubation within a period of~     48 hours to 7 days. Patients who fail extubation are exposed to a longer duration of~     mechanical ventilation, higher rates of ventilator-acquired pneumonia, higher morbidity, and~     higher ICU mortality. Therefore, it is of relevant importance for clinicians to identify~     patients who are at risk of extubation failure as soon as ventilation has been discontinued.~     However, current clinical assessment has poor predictive performance: some physiological~     variables can be helpful but can only be obtained invasively using esophageal and gastric~     catheters.~      Using ultrasound measurements to assess the activity of the respiratory muscles could be of~     particular interest for this purpose. By showing an early recruitment of the accessory~     muscles as well as diaphragm dysfunction or hyperactivity, ultrasounds could help clinicians~     pay greater attention to such patients and therefore try to apply specific therapeutics.~     There are several advantages to ultrasounds: they are non-invasive, available in most~     intensive care units, and previous studies have reported reasonable reliability of the~     measurements.~      In the present study, we aim to assess the contractility of the respiratory muscles~     (diaphragm, intercostal, and sternocleidomastoid) using ultrasounds to identify patients who~     may be at risk of extubation failure and/or ICU readmission.~   "
54531|NCT02853188|"~     The aim of the study is to evaluate if the plasma activity of the tissue factor at the time~     of the diagnosis of a lung cancer, before any treatment, or after the treatment of induction~     (surgery or two first cures of chemotherapy), can be a predictive factor of venous~     thromboembolism disease in the year which follows the diagnosis, independently of the other~     parameters.~   "
54532|NCT02853175|"~     In this diagnostic study, the aim is at evaluating the diagnostic accuracy of MRI (Magnetic~     Resonance Imaging) to detect allergic broncho-pulmonary aspergillosis in patients with cystic~     fibrosis.~   "
54536|NCT02853123|"~     The primary objective of the present study is to evaluate the effect of tiotropium +~     olodaterol fixed dose combination (FDC) compared to tiotropium monotherapy on the intensity~     of breathlessness during the 3min constant speed shuttle test (CSST).~      A secondary objective is to explore the relationship between reductions in breathlessness~     during the 3min CSST and reductions in breathlessness during activities of everyday living as~     measured by the dyspnea domain of the Chronic Respiratory Questionnaire (CRQ) following~     bronchodilator therapy.~   "
54537|NCT02853110|"~     The hypo-FLAME study is a multicenter phase II study (n=100) to investigate whether a focal~     SBRT boost to the MRI-defined macroscopic tumor volume is feasible and associated with~     acceptable toxicity in addition to whole gland prostate SBRT.~   "
54538|NCT02853097|"~     This research trial studies cell-free deoxyribonucleic acid (DNA) and ribonucleic acid (RNA)~     in blood from patients with prostate cancer that does not respond to hormone therapy and has~     spread to other places in the body. Studying samples of blood from patients with prostate~     cancer may help doctors to learn more about the changes that occur in tumor cells over time~     and how they become resistant to anti-cancer drugs.~   "
54539|NCT02853084|"~     This is an open label, single arm trial to evaluate the efficacy, safety, and~     pharmacokinetics of HL2351 in patients with cryopyrin associated periodic syndromes (CAPS).~   "
54540|NCT02853071|"~     This study evaluates efficacy, safety and quality of life in patients affected by metastatic~     breast cancer RH+/ HER2- and treated by estramustine phosphate.~   "
54541|NCT02853058|"~     High Uterine artery index pulsatility (PI) is associated with small for gestationnal age but~     also with stillbirth and distress during labor.~   "
54542|NCT02853045|"~     Despite a large diffusion for generic anti-hypertensive, they are not currently used.~      Clinical validation studies could be better to convince users and prescribers than~     pharmacologic validation only.~      A pragmatic study to evaluate generic anti-hypertensive efficacy is proposed. It takes place~     in real conditions of care for hypertensive patients, for a manometer control criteria.~      The aim of the study is to test the hypothesis of non-inferiority for generic~     anti-hypertensive for blood pressure control.~   "
54543|NCT02853032|"~     Mounting amounts of evidence suggests that non-invasive stimulation of the dorsolateral~     prefrontal cortex (DLPFC) using repetitive transcranial magnetic stimulation (rTMS) maybe a~     safe and effective treatment modality for Post-Traumatic Stress Disorder (PTSD). However the~     large variability in the magnitude of clinical outcomes reported is likely related to the~     current lack of knowledge of ideal side of stimulation (left vs right) and the limited~     precision in the targeting of brain circuits needed to obtain an optimal treatment response.~     In this protocol the investigators will: 1) generate individualized treatment plans based on~     an individual's functional Magnetic Resonance Imaging (fMRI) and meta-analytical based~     connectivity analysis to guide the delivery of adjunct, imaging-based & robotically delivered~     rTMS to active duty military (ADM) subjects with PTSD participating in an intensive program~     providing integrated evidence-based psychotherapy and pharmacological management (Treatment~     as Usual (TAU)). 2) To use clinician ratings and self-report PTSD symptom scales, as well as~     other indicators of clinical change, to determine whether compared with TAU, addition of~     adjunct rTMS improves clinical outcomes. 3) To conduct neuroimaging-based assessments aimed~     to measure rTMS effects on network connectivity in ADM receiving treatment for PTSD and the~     potential correlation of connectivity changes with clinical outcomes.~   "
54544|NCT02853019|"~     Anhedonia and avolition reflect emotional and motivational disorders, respectively. However,~     if these disorders play a major role in the symptomatology of schizophrenia, their mechanisms~     remain poorly understood, and existing treatments are inefficient on these symptoms. The~     literature suggests that the impairment does not concern emotion or motivation per se, but~     rather their influence on cognition. This project aims at using recent advances in the~     fundamental domain to better understand the cognitive and neuronal mechanisms of the~     patients' alterations, and especially how emotion and motivation influence cognition in~     schizophrenia.~   "
54545|NCT02853006|"~     The diagnosis of lung cancer is the first cause of cancer deaths for man and woman. It~     requires invasive procedures (at least endoscopy, transthoracic puncture, or surgery).~      This study is about the set up of an innovative test for lung cancer prognosis, based on~     biopsies and surgical material : LungCancerTest, with the creation of a start-up in progress.~      The main goal of this study is to approve the diagnostic value of the molecular signature of~     the 26 genes (LungCancerTest) revealed in blood and respiratory fluids among patients with~     lung cancer.~   "
54546|NCT02852993|"~     Red blood cell transfusion (RBC) is the main symptomatic treatment for severe anemia. RBC~     transfusion has proven its efficacy regarding mortality and morbidity, but it is not without~     side effects. The infectious side effects of transfusion are largely considered under~     control, non-infectious side effects are taking center stage. Seeking explanations for the~     beneficial and deleterious effects of RBC transfusions is necessary to ensure the safe and~     optimal use of this precious resource.~      The investigators aim to study the impact of donor and RBC characteristics on patient~     survival.~   "
54547|NCT02852980|"~     Retrospective study to estimate screening of the type 2 diabetes of women who had childbirth~     in the Hospital center Rene Dubos and having gestational diabetes.~   "
54548|NCT02852967|"~     This study is being conducted to evaluate the safety, tolerability, and efficacy of KD025 in~     adult subjects with moderate to severe chronic plaque psoriasis.~   "
54549|NCT02852954|"~     Immune system suppression effect of Progesterone Induced Blocking Factor(PIBF), it could be~     questionable whether tumor cells express PIBF for escape of immune system. There are some~     studies in the literature that evaluate PIBF expression of different malign cells (e.g.~     glioblastoma multiforme as a malign central nerve system, leukemia, astrocytoma as a primary~     brain tumor, lung cancer and chorionic carcinoma). According to previous studies PIBF has~     been used as an anti-tumor immune suppressor by tumor cells. There is no data about the PIBF~     expression of endometrial tumor cells. Therefore, the investigators aim to determine the PIBF~     expression levels in the endometrial cancer cells.~   "
54550|NCT02852941|"~     Changes in volumetric hemodynamic parameters and fluid overload (Cardiac Index,Stroke Volume,~     Thoracic Fluid Content, Systemic Vascular Resistance) were measured using a impedance~     cardiography (ICG) (CardioScreen 1000 - Haemodynamic Measurement System, Medis. Ilmenau) in~     stable renal transplant recipients Nutritional status was measured by Tanita 418 Monitor.~   "
54551|NCT02852928|"~     Generation of a common European database and biobank Continous assessment and implementation~     of guidelines and treatment protocols Establishment of a large observational cohort of chILD~     patients Determination the value of outcomes used in child Assess treatment variations used,~     deliver data from defined protocols and linked outcomes~   "
54552|NCT02852915|"~     The purpose of this study is to compare the short- and long-term survival of laparoscopic~     surgery and conventional open surgery for T4 colon cancer.~   "
54553|NCT02852902|"~     Main objective: to observationally assess the efficacy and safety of different antimicrobials~     in BSI due to ESBL or carbapenemase-producing Enterobacteriaceae in SOT.~      Secondary objectives:~        1. To evaluate the efficacy and safety of different antibiotics used for the treatment of~          infections caused by ESBL- and carbapenemase-producing Enterobacteriaceae in the SOT~          population.~        2. To compare the efficacy of different antimicrobials between SOT and non-SOT patients~          (using matched controls from the non-transplant INCREMENT cohort).~        3. To create a microbiological collection of ESBL- and carbapenemase-producing~          Enterobacteriaceae isolated from the SOT population.~        4. To provide data on specific MICs for each antimicrobial evaluated.~        5. To provide data on the prevalence of specific mechanisms of resistance and their~          clinical impact in the particular setting of SOT.~        6. To organise an international consortium capable of developing high quality prospective~          cohort studies and randomised clinical trials in the area of MDR and XDR~          Enterobacteriaceae in SOT.~   "
54554|NCT02852889|"~     The purpose of the study was to verify the efficacy of using internal jugular vein (IJV) size~     and distensibility as an index of fluid responsiveness in mechanically ventilated patients~     after cardiac surgery.~   "
54555|NCT02852876|"~     The objective of this study is to evaluate the safety and tolerability of single rising doses~     of ASP2151 under fasted condition in healthy male subjects.~      The study will also evaluate the pharmacokinetics (PK) of a single dose of ASP2151 under~     fasted versus fed conditions in healthy male subjects.~   "
54556|NCT02852863|"~     To identify by ultrasound the possible changes in gastric volume and content after chewing~     gum for an hour in volunteers with complete fasting (more than 8 hours).~   "
54557|NCT02852850|"~     Molecular imaging with infliximab antibody with FITC has the potential to predict therapeutic~     responses to infliximab antibody and can be used for personalized medicine in ulcerative~     colitis.~   "
54558|NCT02852837|"~     The purpose of this study is to evaluate the tolerability, safety and the pharmacokinetic~     (PK) profile of daratumumab in Chinese participants with relapsed or refractory multiple~     myeloma (RRMM) who failed at least 2 prior lines of systemic therapy (Part 1 and Part 2); and~     to evaluate the tolerability and safety of daratumumab in Chinese participants whose prior~     therapy included a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) and who have~     demonstrated disease progression on the last therapy (Part 3).~   "
54559|NCT02852824|"~     The primary objective of this trial is to investigate the safety and tolerability of BI~     655130 in healthy male subjects following IV administration of multiple rising doses. The~     study will also explore safety and tolerability following a single IV administration.~   "
54560|NCT02852811|"~     The aim of the study is to investigate if group education about the topic menopause to women~     in PHC can improve women's menopausal symptoms and reduce depression.~   "
54561|NCT02852798|"~     This is a clinical study of Apatinib Mesylate Tablets combined with docetaxel monotherapy as~     second-line therapy of advanced EGFR wild-type, non-squamous, non-small-cell lung cancer.~   "
54562|NCT02852785|"~     The main purpose of this study is to characterize and compare the 3D shoulder kinematics~     bilaterally while performing functional movement patterns tests that hypothetically replicate~     the 5 main phases of the throwing cycle. The tests are based on diagonal D2 for flexion~     (early and late cocking of the arm) and D2 for extension (acceleration, deceleration and~     follow-through of the arm) of the upper extremity of proprioceptive neuromuscular~     facilitation techniques.~   "
54563|NCT02852772|"~     Chronic kidney disease (CKD), frequent in PLHIV, is a risk factor for cognitive impairment.~     Micro-albuminuria is an early manifestation of CKD and a marker of vascular risk, notably~     affecting the small vessels. In the older general population microalbuminuria is associated~     with greater annual cognitive decline and has been proposed as an easily and inexpensive~     measured marker predicting future cognitive function decline. Ageing of the PLH leads to an~     increase of cognitive disorders and chronic renal failure incidence and could imply a common~     underlying mechanism affecting the renal and cerebral microvasculature. In this setting the~     investigators undertake this prospective, cross-sectional, case-control study to determine~     whether the presence of a microalbuminuria at least 5 years ago in PLHs with sustained good~     combination antiretroviral therapy (cART)-controlled immunovirological parameters could be a~     marker predicting future cognitive impairment. They chose PLHs infected for at least 5 years~     and with cART-sustained immunovirological control for at least 1 year.~   "
54564|NCT02852759|"~     Insulin resistant volunteers will choose to undergo an 8-week cold treatment, 2 hours per~     day, to selective regions of the body enriched with brown fat including neck, supraclavicular~     and interscapular regions) in combination with electroacupuncture (EA). Their insulin~     sensitivity and glucose and lipid homeostasis will be measured. The brown fat activation will~     be assessed by positron emission tomography and computed tomography (PET/CT)-scans and/or~     serum marker measurements.~   "
54565|NCT02852746|"~     The study aims to compare the performance and the 3D shoulder kinematics of volleyball~     attackers with and without scapular dyskinesis and shoulder symptoms in two physical~     performance measures of the upper extremity, and correlate their outcomes with a~     self-reported measure of function of the upper extremity.~   "
54566|NCT02852733|"~     The purposes of this study are :~        -  To know and to understand frequency and variability (quantitative and qualitative) of~          end-of-life emergencies in nursing homes.~        -  To know and to understand practices applied in these situations depending on the~          institution and the different reasons of hospital use.~        -  To know and to understand the practical and organizational elements, in nursing homes,~          that can determine a (re) hospitalization or an end-of-life~   "
54580|NCT02852551|"~     A single‑center, randomized, placebo‑controlled study consisting of both a single ascending~     dose (SAD) and a multiple ascending dose (MAD) portion to evaluate the safety, tolerability,~     pharmacokinetics and effect of food using PAT‑1251 orally administered to healthy subjects~   "
54567|NCT02852720|"~     Transversus abdominis plane (TAP) block provides effective analgesia and is now a standard of~     care for analgesia after cesarean section. There is no information on levobupivacaine~     pharmacokinetics post TAP after pregnancy.~      Objective: Generate a pharmacokinetic levobupivacaine model and its effect on the~     electrocardiogram (ECG).~      Method: The investigators will study 12 healthy term pregnant patients, scheduled for~     elective cesarean section under spinal anesthesia. A bilateral TAP block is performed with 20~     ml 0.25% levobupivacaine with epinephrine 5 ug/ml. Sensory block will be assessed at 1-2-6~     and 12 hours post puncture. 2 ml of venous blood will be obtained at 2-5-10-30-45-60-90 and~     180 minutes. With a Holter machine we will study the effect of levobupivacaine plasma levels~     and the QTc changes.~      Expected results: 1) Plasma levobupivacaine levels; 2) Changes in QTc .~   "
54568|NCT02852707|"~     This study compares the performance and 3-dimensional shoulder kinematics between sides in~     unilateral overhead-throwers (volleyball attackers), bilateral overhead athletes (swimmers)~     and non-athletes during two physical performance measures of the upper extremity, one in an~     open kinetic chain position (unilateral seated shot put test) and the other in a closed~     kinetic chain position (upper quarter Y balance test)~   "
54569|NCT02852694|"~     The purpose of this study is to compare the effectiveness of weekly subcutaneously~     administered Methotrexate for maintaining relapse-free sustained steroid/Enteral Nutrition~     -free 1-year remission compared with:~        -  daily oral Azathioprine / 6 mercaptopurine in low risk paediatric Crohn's disease~        -  subcutaneously administered adalimumab in high risk paediatric Crohn's disease~   "
54570|NCT02852681|"~     This single-center, open-label, randomized, balanced, single-dose, two-treatment, two-period,~     two-sequence crossover study was conducted under medical supervision in 28 healthy female~     volunteers.~   "
54571|NCT02852668|"~     The inexorable decline in motor skills during aging provides the investigators with an~     elderly population with various functional limitations. Among these, the ability to walk,~     being associated with the risk of falling has been studied by several authors. The adoption~     of strength and power training as an intervention strategy to reduce the negative effects~     arising from the physiological or pathological process of aging has been widely discussed in~     these studies. However, the effects of these interventions on biomechanical gait indicators~     have not been fully debated yet. Therefore, this study aimed to compare the effects of these~     two training protocols on functional capacities and biomechanical gait parameters of elderly~     women.~   "
54572|NCT02852655|"~     This research study is studying an immunotherapy as a possible treatment for Glioblastoma.~   "
54573|NCT02852642|"~     Introduction: the physiological aging process induces several structural changes in the~     musculoskeletal system. These, in turn, result in functional changes that are reflected in~     the senescent dependency, determining the reduction in their quality of life. Power training~     has been identified as ideal to mitigate the effects of aging. However, there are indications~     that an intervention based on the potentiation of the stretch-shortening cycle action is a~     better choice.~   "
54574|NCT02852629|"~     Observational two year study to evaluate the utility of a decision-support sheet on how to~     proceed in case of aggravation of a patient's condition with advanced disease.~   "
54575|NCT02852616|"~     Narrative Exposure Therapy (NET) has been proven to be effective in the treatment of~     Posttraumatic Stress Disorder (PTSD) and trauma-related depression in more than a dozen~     controlled clinical trials. Symptom reduction was greatest during long-term follow-ups after~     the completion of the therapy.~      In the current study, we will investigate the progression of PTSD symptoms and emotional~     stress before, during and after therapy. After a semi-structured interview all participants~     will be asked to report in monthly telephone interviews their core symptoms. Structured~     interviews after 6 and 12 months are used to validate the outcome. A convenience sample of~     individuals with a PTSD will be offered participation in the study.~   "
54576|NCT02852603|"~     Mortality of thoracic aortic aneurysm and dissection (TAAD) remains high because of the huge~     blood lost from the aorta. Questions about the potentially genetic effects on sporadic TAAD~     are raised by researchers to explore the possible mechanisms leading to sporadic TAAD and to~     establish new clinical approaches to prevent TAAD-caused adverse clinical outcomes. This~     study is intended to collect the gene information in sporadic TAAD patients and to explore~     the relationship between genetic variation and the incidence of sporadic TAAD for further~     study.~   "
54577|NCT02852590|"~     Medications are the most commonly used clinical intervention and complications associated~     with their use are one of the most common causes of adverse events in health care. Adverse~     Drug Reactions (ADR) are a major cause of morbidity and pose a substantial burden on limited~     health care resources.~      Many drugs used to treat children in hospitals are either not licensed for use in children or~     are prescribed outside the terms of their product license (off-label prescribing). This is~     mainly due to the lack of clinical trials in this vulnerable population, and both practical~     difficulties and ethical considerations arising from involving children in clinical research.~      Drugs used within the specifications of the product license might be less likely to cause ADR~     compared to drugs that are either unlicensed or off-label for use in children. Few studies~     have shown a significant association between pediatric off-label drug use and ADR.~      To compare the probability of ADR after a licensed drug prescription versus the probability~     of ADR after prescribing a drug off-label in children, we are conducting a multi-center~     prospective observational study in different pediatric hospital wards in France.~      The availability of electronic health records made this study feasible. An automatic data~     extraction from hospital information systems has been implemented. A computer algorithm for~     determining pediatric drug labelling (i.e. off-label or unlicensed use) using the French~     summaries of product characteristics available in Thériaque® database has been developed.~     Detection of ADRs is carried out by health care professionals and research groups using a~     trigger tool and patients' electronic health records. The causality between ADRs and~     suspected medications is evaluated using the Naranjo and the French methods by regional~     pharmacovigilance centers. An independent pharmacovigilance board validates ADR evaluations,~     assesses both of their severity and avoidability, and indicates therapeutic alternatives to~     suspected medications.~      This is, to our knowledge, the first large multi-center and prospective study in France that~     evaluates the relationship between adverse drug reactions and unlicensed/ off-label drugs use~     in hospitalized children. The results of this study will provide more information on the~     prescription practice and the amplitude, nature and consequences of unlicensed/off-label drug~     use in hospitalized children. It will also help identify the risk factors of ADR that could~     be used to implement preventive actions, and guide future research in the field. An indirect~     benefit is represented by the increase of physicians' awareness in detecting and declaring~     ADRs and by communicating the results to the health professionals and to the public. This~     study is funded by ANSM (the French Medicine Agency).~   "
54578|NCT02852577|"~     The purpose of this study was to determine whether clonazepam and paroxetine are effective in~     the treatment of panic disorder. Efficacy was evaluated in short-term, long-term and~     post-treatment.~   "
54579|NCT02852564|"~     Phase 1 study to provide quantitative characterization of the renal elimination of ethacrynic~     acid and metabolites in patients with non-muscle invasive bladder cancer (NMIBC) at the time~     of transurethral resection of bladder tumor~   "
54584|NCT02852499|"~     The SEPAGES couple-child cohort is coordinated by an Inserm (French National Institute of~     Health and Medical Research) team of environmental epidemiology. SEPAGES cohort is based on~     the general population and aims to cover several areas of environmental health research,~     including endocrine disruptors and air pollutants.~      The main objectives is to quantify the impact of pollution during pregnancy and the first~     years of life on three main health outcomes : growth, respiratory health and~     neuro-development ; and to better understand the biological mechanism (such as genetic~     analysis to study the role of environmental factors on genes expression as well as the role~     of genetic factors on health). The objective is to include 500 families.~   "
54585|NCT02852486|"~     The purpose of this study is to evaluate treatment-free remission after imatinib~     discontinuation in patients with chronic myeloid leukemia with deep molecular response.~     Before discontinuation, patients will receive pioglitazone associated with imatinib during 3~     months.~   "
54586|NCT02852473|"~     This study involves a breathing motion assessment in healthy subjects before and after~     continuous positive airway pressure (CPAP) administration using MRI images.~      The hypothesis for this study is that CPAP administration will significantly reduce breathing~     motion. This may help cancer patients who are undergoing proton radiotherapy, so they~     possibly will not have to hold their breath during the procedure.~   "
54587|NCT02852460|"~     To evaluate the influence of rapid recovery on sleep quality following total hip replacement~     surgery~   "
54588|NCT02852447|"~     The main objective is to evaluate the ovarian reserve after laparoscopic cystectomy.~      The secondary objective is the analysis of predictors of change in the ovarian reserve after~     surgery~   "
54589|NCT02852434|"~     This study seeks to compare self-administered lidocaine gel for pain control during cervical~     preparation for dilation and evacuation (D&E) to paracervical block.~   "
54590|NCT02852421|"~     Paravertebral block (PVB) has been shown to provide excellent analgesia for major breast~     surgeries resulting in reduced narcotic consumption, reduced nausea, improved quality of~     recovery, reduced chronic pain and possibly reduced metastasis with breast cancer.~     Traditionally, PVB is done by multiple injections below T1-T5 transverse processes. With~     multiple injections, the risk is increased for a pleural, an intraneural, and/or an~     intravascular injection. Recently, ultrasonography is being used to facilitate PVB. The use~     of ultrasound imaging enables real-time needle visualization during the procedure. This may~     improve efficacy and reduce the chances of complication like pneumothorax. Currently, there~     are no data comparing ultrasound-guided single injection technique with multiple injections~     technique with regards to extent of spread for PVB. Our objective is to investigate the~     extent of dermatomal spread of PVB when equal volumes of local anesthetic are injected at one~     versus five paravertebral sites for patients undergoing major breast surgery. In addition,~     the investigators wish to compare the performance time and duration of analgesia.~      Methodology: After local REB approval, 72 patients undergoing a unilateral mastectomy with or~     without axillary node dissection will be randomized to receive either single or multiple~     injections PVB. The PVB will be performed in prone position under real-time ultrasound~     guidance using a para-sagittal approach.The patients in single injection group will receive~     single injection PVB at T3-T4 level with 25 ml of 0.5% ropivacaine and four subcutaneous sham~     injections. Patients in the multiple injection group will receive five injections of PVB from~     T1 to T5 level. 5 ml of 0.5% ropivacaine will be injected at each level. Pleural drift will~     be used as a sign of correct needle tip location and local anaesthetic spread. The pinprick~     method will be used to assess the extent of dermatomal blockade, 20 minutes following the~     completion of procedure. All patients will receive a standardized general anesthesia for the~     surgery. Any adverse events including pneumothorax, epidural spread, LA toxicity/seizure,~     total spinal, will be recorded.~   "
54591|NCT02852408|"~     Laparoscopic cholecystectomy is a common accepted surgical operation with lower morbidity all~     over the world for gallstone. Although it has low morbidity, postoperative pain is~     challenging situation like every other operation.~   "
54592|NCT02852395|"~     This is a 3-part study to evaluate the safety, tolerability, pharmacokinetics, and~     pharmacodynamics of JNJ-48816274 in healthy participants after administration of single and~     repeated doses, and to evaluate its potential effectiveness for treating insomnia.~   "
54593|NCT02852382|"~     This study evaluate the effects of scalp block versus local infiltration on haemodynamic~     response to head pin replacement and skin incision and postoperative analgesia in posterior~     fossa surgery~   "
54594|NCT02852369|"~     Objective: To determine the effectiveness of an upper extremity, task oriented training~     program delivered at home (TOTE Home) for people who are in the subacute recovery phase of a~     stroke.~      Method: A single-subject AB series design with a follow-up to assess the effectiveness of~     TOTE Home which includes a maximum of 30, one hour sessions of training conducted in~     participants' homes. Repeated target measures of accelerometry and level of confidence to be~     analyzed throughout the study. Change scores from standardized assessments to be evaluated at~     baseline, post-intervention, and follow-up time periods.~   "
54595|NCT02852356|"~     The purpose of this study is to evaluate the safety and efficacy of the MIRI-TL time-lapse~     incubator and CultureCoin dish compared to standard big-box incubators and standard culture~     dishes used for embryo culture.~   "
54596|NCT02852343|"~     The investigators main objective is to show that OSNA technique is as accurate as~     pathological analysis (frozen section / HE staining and immunochemistry) to detect occult~     lymph node metastasis (micro and macrometastasis).~   "
54597|NCT02852330|"~     Collection of normative voltage tomography data during and/or immediately after electrode~     insertion into the cochlea using Surgical Assistant (SA16) research software and~     postoperatively at activation, three and twelve months post-activation with CS19 research~     software in adults who are receiving a Cochlear Nucleus CI512, CI422, CI522 or CI532 cochlear~     implant.~   "
54598|NCT02852317|"~     The purpose of this study is to assess diagnostic performance of urinary markers of detrusor~     overactivity (Nerve Growth Factor (NGF), Brain-Derived Neurotrophic Factor (BDNF), adenosine~     triphosphate (ATP), Prostaglandine E2) in detected high pressure bladder un spina bifida~     patients.~   "
54622|NCT02852005|"~     The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the~     AIDSVAX B/E vaccine and the MVA/HIV62B vaccine in healthy, HIV-1-uninfected adults who~     previously received MVA/HIV62B in DNA/MVA or MVA/MVA vaccine regimens in the HVTN 205 study.~   "
54623|NCT02851992|"~     This is a multicenter, non-controlled, prospective study. 250 subjects (GTS standard and~     lateralized) will be recruited. Study will be conducted in centers across Europe.~   "
54638|NCT02851797|"~     it is a randomised, double blind, parallel group, placebo controlled study. A total of 213~     male ambulant subjects will be randomised 2:1 (givinostat:placebo).~      Subjects will be stratified for their concomitant use of steroids in 4 strata:~        1. Deflazacort daily regimen~        2. Deflazacort intermittent regimen~        3. Other steroids daily regimen~        4. Other steroids intermittent regimen. The study duration is planned for 19 months.~   "
54599|NCT02852304|"~     Lysosomal Acid Lipase (LAL) deficiency is a rare, autosomal recessive storage disease linked~     to decrease enzymatic activity of LAL, responsible for intracellular accumulation of~     cholesterol esters and triglycerides.~      The accumulation of lipid is in hepatocytes, Kupffer cells and macrophages leading to a fatty~     liver, hepatic fibrosis that can evolve up to cirrhosis.~      LAL deficiency is responsible for significant morbidity and early mortality in children,~     adolescents and adults in connection with a multi visceral disease reaching the liver,~     gastrointestinal tract and the vascular endothelium. The disease is caused by homozygous or~     heterozygous mutations in the gene (LIPA chromosome 10q23.2-23.3) which is responsible for~     the synthesis of the LAL.~      The disease can be diagnosed by enzymatic analysis using few drops of blood absorbed onto~     blotting paper .~      Patients with this deficiency LAL, have no or reduced activity of this enzyme. Because of its~     rarity, the deficit in LAL is under diagnosed or is diagnosed in patients with liver~     biological disturbances and / or lipid profile disturbances, steatohepatitis-hepatitis~     (NASH), the steatosis (NAFLD), the cryptogenic cirrhosis or Wilson disease.~      Inclusion period of 12 to 18 months (100 patients).~   "
54600|NCT02852291|"~     Multisite randomized trial of a parenting intervention in Liberia for caregivers of young~     children. Two main objectives of the Parents Make the Difference program are to teach~     parents (a) skills for decreasing harsh punishments and replacing those with positive ways to~     manage children's behavior and (b) skills for having more positive interactions with their~     children, including interactions that encourage learning. As a result of positive changes in~     parenting, the investigators expect that, over time, children's behavioral and cognitive~     well-being will improve and that future abuse and poor developmental outcomes will be~     prevented in the long-term.~   "
54601|NCT02852278|"~     The purpose of this study is to learn about rates of patient-reported disease progression in~     patients with motor neuron diseases (amyotrophic lateral sclerosis, progressive muscular~     atrophy, primary lateral sclerosis, hereditary spastic paraplegia) outside the clinical~     setting, and the patient-reported clinical characteristics that influence this rate of~     progression. All patients enrolled in CReATe Connect, a Rare Diseases Clinical Research~     Network (RDCRN) Contact Registry, will be invited via email to participate in this study.~   "
54602|NCT02852265|"~     Women currently using or starting a combined oral contraceptive will be offered study~     enrollment. Study subjects will have a Nexplanon placed and followed for 6 months to evaluate~     if they continue the COC, continue the implant, or both, and to assess adverse events and~     bleeding patterns.~   "
54603|NCT02852252|"~     The study objective is to collect prospective data on cancer patients who undergo surgery and~     intraoperative imaging. The registry will include (but not limited to) cancer type, stage,~     intraoperative challenges to the surgeon, usage and results of intraoperative imaging, and~     recurrence surveillance.~   "
54604|NCT02852239|"~     To characterize the pharmacokinetics and safety of dabrafenib following a single 100 mg oral~     dose in subjects with severe renal impairment and end stage renal disease not on dialysis.~   "
54605|NCT02852226|"~     UCSF is conducting an evaluation of a demonstration project. The aims of the CRUSH-PrEP for~     Women project are to integrate the delivery of a comprehensive PrEP package for HIV-negative~     at-risk women into primary care settings. The delivery of the PrEP package will leverage the~     well regarded reputation of the LifeLong primary care clinicians to provide a highly~     effective combination HIV prevention strategy including; PrEP, post-exposure prophylaxis~     (nPEP), repeat HIV and STI testing, treatment of sexually transmitted infections. Counselling~     for for sexual health promotion and services specifically designed for vulnerable women such~     as staying free of violence and domestic abuse will be offered as an integrated part of this~     package. UCSF will conduct evaluation activities only. The investigators expect that UCSF~     will enroll 50 participants in the evaluation assessments across the 15 months of data~     collection. Evaluation cohort participants will provide quantitative data to evaluate the~     linkage and engagement in care among clinic attendees as well as the uptake and use of~     Pre-Exposure Prophylaxis.~   "
54606|NCT02852213|"~     The overall objective of this study is to determine the safety and efficacy of AAV2-hAADC~     delivered to the substantia nigra pars compacta (SNc) and ventral tegmental area (VTA) in~     children with aromatic L-amino acid decarboxylase (AADC) deficiency.~   "
54607|NCT02852200|"~     Many tools to evaluate frailty have been developed. However, at the time our study was~     designed, none of these instruments had been validated in terms of psychometric properties.~     The aim of this study was to validate the modified version of the Short Emergency Geriatric~     Assessment (SEGAm) frailty instrument in elderly people living at home.~      It was an observational, longitudinal, prospective, multicentre study, set up in four~     departments (Ardennes, Marne, Meurthe-et-Moselle, Meuse) in two French regions~     (Champagne-Ardenne and Lorraine). Subjects was aged 65 years or more, living at home, and was~     able to read and understand French, with a degree of autonomy corresponding to groups 5, or 6~     in the AGGIR autonomy evaluation scale. Assessment included demographic characteristics,~     comprehensive geriatric assessment, and the SEGAm instrument. Psychometric validation was~     used to study feasibility and acceptability, internal structure validity, reliability, and~     discriminant validity of the SEGAm instrument. ~   "
54608|NCT02852187|"~     Prospective randomized clinical study comparing Signus MOBIS PEEK vs SIGNUS MOBIS II ST in~     patients with Degenerative Disc Disease at one or two contiguous levels from L2-S1~   "
54609|NCT02852174|"~     Caring for a disabled adult, particularly those with long-lasting impairment, has been~     associated with elevated levels of stress, depression and anxiety among caregivers.Recent~     studies show that veteran caregivers experience higher levels of psychological distress than~     caregivers in the general population, highlighting the psychological needs of this~     population. The Veteran Caregiver Reducing Stress Time (VetCareReST) is a randomized control~     trial designed to test the effectiveness of a mindfulness at reducing stress, depression and~     anxiety in veteran caregivers in Champaign and Danville County.~   "
54610|NCT02852161|"~     A pilot study to assess the accuracy and acceptability of a magnet assisted capsule endoscopy~     in detecting esophageal pathology compared to standard endoscopy.~   "
54639|NCT02851784|"~     The study is to observe safety, survival effect and peripheral T-lymphocyte subsets of~     combination therapy with percutaneous microwave ablation (MWA) and adoptive immunotherapy in~     hepatocellular carcinoma(HCC).~   "
54611|NCT02852148|"~     The aim of the study is to evaluate participant reported quality of life, safety, and overall~     performance with ACTICOAT in a clinical setting.~      ACTICOAT is a silver coated antimicrobial barrier wound dressing for the treatment of a~     variety of wound types. It is widely used in routine clinical practice within the UK.~     ACTICOAT is CE marked and will be used within the intended indications for use. The proposed~     study is required for regulatory purposes.~      Primary Objective: To evaluate change in health related quality of life, associated with~     treatment. The primary outcome measure / endpoint will be change in EQ-5D 5L mean single~     index utility scores from baseline to 3 weeks.~      The study will also seek to gather and report relevant safety and performance data and~     evaluate change, where applicable, for outcomes including: clinical signs and symptoms of~     infection; wound length / width / depth; wound healing measures; tissue staining; pain,~     adherence, and pain on application / removal; wear time; adverse events and device~     deficiencies.~      In total 25 participants will be recruited into the trial, comprising a minimum of 8~     participants with a full or partial thickness burn and a minimum of 8 participants with a~     full or partial thickness chronic wound. All participants will have their wound dressed using~     ACTICOAT, and will be followed-up for 3 weeks.~   "
54612|NCT02852135|"~     The LMA Proseal and LMA Supreme are the third generation of LMA with potential advantages~     over the classic LMA.Several publications have reported the successful, safe use of Laryngeal~     Mask Airway devices in patients undergoing laparoscopic surgery. However, there have been no~     studies that have examined the application of LMA in patients during lateral positioned~     laparoscopic surgery. The aim of this study is to observe the safety and efficacy when LMA~     Proseal and LMA Supreme used in lateral positioned laparoscopic surgery under general~     anesthesia.~   "
54613|NCT02852122|"~     The investigators determine the target number as 54 patients based on the following reasons:~     (a) The bony metastasis rate for the high risk prostate cancer patients with PSA from 20 to~     99.9 ng/ml was 21% (166/767 cases in a systemic review) [8]; the estimated sample size would~     be 47 under the condition of 20% more distant metastasis cases were identified by the PET/MRI~     scan using the 90% power, significance level of 0.05 and one sample proportion test. Assuming~     a dropout rate of 10%, the final ideal sample size is 52 patients. (b) The newly diagnostic~     number for the high risk prostate cancer patients in our hospital annually is ~70, about 6~     patients a month. It is clinically feasible to recruit 3 patients a month until 18 months~     since the study begin. The study could be completed in 2 years with 54 cases~   "
54614|NCT02852109|"~     The investigators will examine 15 patients who was firstly diagnosed as diffuse axonal injury~     and 15 patients negative for magnetic resonance examination with no trauma with DTI(diffusion~     tensor imaging). The investigators then determine the FA（fractional anisotropy）value and the~     ADC(apparent diffusion coefficient) value of relational interesting area（corpus~     callosum、brainstem、basal ganglia）to analyse the correlation between the FA（fractional~     anisotropy）value and ADC(apparent diffusion coefficient) value and GCS(Glasgow Coma Scale)~     and coma time,so that the investigators can quantify the damage degree of patients' white~     matter fiber.By using fiber tractography the investigators can have the extent of recovery of~     the patient of DAI（diffuse axonal injury） in real-time detection and give guidance for the~     clinical decision and the judgement of prognosis).~   "
54615|NCT02852096|"~     One paraffin block is routinely used for Human Epidermal Growth Factor Receptor 2 (Her2/neu)~     immunohistochemistry (IHC) assessment. Here, investigators investigated if picking two or~     multiple paraffin blocks for Her2/neu evaluation is an economical, efficient and practical~     method, which may reduce false-negativity of Her2/neu IHC assessment due to intratumoral~     heterogeneity.~   "
54616|NCT02852083|"~     This is a Phase II, multicentre, open-label, randomized, and controlled study, evaluating the~     efficacy and safety of combined modularized treatment of treosulfan, pioglitazone and~     clarithromycin in patients with with squamous and non- squamous cell lung cancer,~     respectively after platin failure.~   "
54617|NCT02852070|"~     Comparison of microbiological yield from Bronchoalveolar Lavage Fluid (BALF) for the two~     common-used volume bronchoalveolar lavages(60ml and 120ml)in patients with different types of~     lower respiratory tract infection.~      Assessment of the safety of two common-used volume bronchoalveolar lavages(60ml and 120ml),~     including the incidence of hospital-acquired pneumonia within 14 days after bronchoscopy, and~     other bronchoalveolar lavage related adverse events.~   "
54618|NCT02852057|"~     This study focuses on glaucoma therapy by drug eluting contact lenses. The contact lens will~     be loaded with timolol maleate and dorzolamide hydrochloride, both of which are commonly used~     ophthalmic drugs. Additionally, the lenses will contain vitamin E ((+) α-tocopherol) as an~     additive for achieving extended release of the drugs.~      This study is to assess the safety of the drug loaded contact lenses and the effectiveness.~     Effectiveness will be a drop in IOP after using the lenses.~   "
54619|NCT02852044|"~     For decades, it has been known that post-meal blood glucose concentrations were associated~     with the risk of T2D, which was reflected in early diagnostic guidelines. The oral glucose~     tolerance test (OGTT) has been used since at least 1923 and has remained the most common test~     for assessing glucose tolerance. Arterial blood (or arterialised blood using heated hand~     technique) is most appropriate for determining glucose tolerance and insulin sensitivity~     since this best represents the concentrations of metabolites and hormones that peripheral~     tissues are exposed to. It is essential to investigate whether venous blood (sometimes used~     during an OGTT) is representative of arterialised blood during an OGTT, and under different~     metabolic conditions.~      The investigators want to understand whether OGTT-derived insulin sensitivity indices differ~     from venous and arterialised blood; and 2) investigate whether metabolic status (i.e. rest vs~     lower-limb exercise) influences the difference between forearm venous and arterialised~     concentrations of glucose and insulin during an OGTT.~   "
54620|NCT02852031|"~     The purpose of this initiative is to improve care and outcomes for infants with HLHS by~     expanding the NPC-QIC national registry to gather clinical care process, outcome, and~     developmental data on infants with HLHS between diagnosis and 12 months of age, by improving~     the use of standards into everyday practice across pediatric cardiology centers, and by~     engaging parents as partners in the process.~   "
54621|NCT02852018|"~     The aim of this project is to identify common genetic polymorphisms associated with the~     occurrence of rhythmic events in patients with severe cardiomyopathy.~   "
54624|NCT02851979|"~     Apneas concern about 85% of premature newborns (NB) born after less than 34 weeks of~     pregnancy. They are considered as an important risk factor for subsequent neuropsychological~     deficiency. Current pharmacological treatments are not very effective, and have side effects~     (agitation, irritability, sleep disorders, tachycardia). Some studies suggest that in NBs~     with apneas resisting to drugs, a permanent odorisation with a drop of vanillin on the~     incubator's pillow might reduce the frequency of apneas. This latin square design study will~     test a controlled olfactory stimulation method, i.e. an olfactometer which controls the odor~     duration, intensity, and sequence using three different odors, to reduce apneic episodes~     measured using 24-registration of heart and respiratory rates.~   "
54625|NCT02851966|"~     The investigators hypothesize that sperm production varies with time in men with no sperm in~     semen (non-obstructive azoospermia, NOA) and that the semen protein, TEX101, is able to~     monitor these changes. The investigators further hypothesize that TEX101 levels may be used~     to predict the optimum time for microsurgical testicular sperm extraction (mTESE) to provide~     the highest successful rates of sperm retrieval.~   "
54626|NCT02851953|"~     The purpose of the present clinical investigation is to collect data regarding the safety and~     effectiveness of the Aqueduct 100 device.~      The effectiveness of the Aqueduct 100 will be determined by evaluating the ability to reach~     desired cervical dilation, and the time frame required to reach desired cervical dilation.~   "
54627|NCT02851940|"~     The investigators aim at prospectively comparing procedural pain, adverse events and~     rebleeding rates of anoscopic rubber band ligation and endoscopic hypertonic saline injection~     in patients with symptomatic hemorrhoidal disease~   "
54628|NCT02851927|"~     Undiagnosed pleural effusion is a diagnostic dilemma especially in exudative pleural~     effusions (EPE). 20-40 % are unable to be attributed to a specific diagnosis, even after~     thoracentesis and closed pleural biopsy. Thoracoscopy has been demonstrated to increase the~     diagnostic yield in undiagnosed EPE. The diagnostic yield of thoracoscopy in malignant and TB~     pleural effusion ranges from 91% to 94% and 93% to 100%, respectively.~      Rigid thoracoscopy has traditionally been the modality of choice. The recently introduced~     semirigid thoracoscope provides ease of handling like a flexible bronchoscope. However, there~     are concerns about the diagnostic yield of semi-rigid thoracoscopy when compared with rigid~     thoracoscopy. According to the available literature, the yield of semirigid and rigid~     thoracoscopy is almost similar if adequate pleural biopsy is obtained. However there are~     concerns that with semi-rigid thoracoscope, there might be greater incidence of inability to~     obtain adequate pleural biopsy. On the other hand, the use of conventional rigid thoracoscope~     may be associated with greater procedure related pain.Mini-Thoracoscopy is a newer rigid~     thoracoscopy instrument which is smaller in diameter (5.5 mm) and may allow pleural biopsy~     with a smaller incision. There is scant literature on its utility. The investigators hereby~     propose to undertake a randomized comparison of rigid 'mini thoracoscope' vs semi rigid~     tharacoscope in undiagnosed pleural effusions.~   "
54629|NCT02851914|"~     Depression is seen in 9-11% of ALS patients and adequate and proper treatment is needed. In~     this study, ALS patients will be screened for depression using self-reported multiple choice~     questionnaire. Patients who fulfill the criteria for depression based on this screening tool~     will be evaluated by psychiatrist before inclusion in the study. The investigators will also~     measure quality of life and functional status by simple questionnaires. The patients will be~     allocated into two treatment groups to receive either TCA or SSRI for 12 weeks. Patients will~     be evaluated every 4 weeks and phone calls will be made in between the visits if needed to~     assess about efficacy and any side effects. If any patient reports having suicidal thoughts~     on any of these phone calls or clinic visits, he/she will be immediately sent to the ER for~     appropriate management. The investigators will repeat the questionnaires in the clinic~     visits, and use them in the data analysis to look for any improvement and to compare the two~     medication classes used in this study. This data may be used later on to do larger studies~     and help to make standard recommendations in treating depression in ALS patients.~   "
54630|NCT02851901|"~     This double-blind placebo-controlled design with 374 cancer patients will compare standard~     varenicline treatment (12-weeks active + 12-weeks placebo) to extended varenicline treatment~     (24-weeks active) for increasing week 24 & 52 biochemically-confirmed 7-day point prevalence~     abstinence, assess effects of extended varenicline therapy on QOL, including varenicline side~     effects, and assess changes in affect & cognitive impairment as mediators of extended~     varenicline therapy effect on quit rates.~   "
54631|NCT02851888|"~     The purpose of this research is to determine differences in outcomes in patients who do, or~     do not, receive regional anesthesia (a fascia iliaca block) prior to undergoing hip~     arthroscopy with labral repair and/or debridement and osteoplasty for hip impingement~   "
54632|NCT02851875|"~     The purpose of the Duke Scleroderma Registry (DSScR) is to obtain information about~     scleroderma. This information could be used in future research to increase the understanding~     of disease mechanisms, treatments, and outcomes. This research may also help develop new~     therapies, novel measures of disease assessment or identify previously unknown manifestations~     of the diseases. A prospectively followed cohort is an integral component of future~     translational and clinical research programs. A registry for scleroderma would allow for~     information to be gleaned about patients in real-world situations in an effort to improve~     the reality, generalizability and applicability of information gathered.~   "
54633|NCT02851862|"~     The purpose of this study is to learn more about the natural history of Late Onset GM2~     Gangliosidosis (Tay-Sachs disease and Sandhoff Disease) to inform future clinical trials.~   "
54634|NCT02851849|"~     The purpose of this study is to evaluate the change from baseline in hemoglobin A1c (HbA1c)~     during 12 weeks of treatment with 3 dose levels of LGD-6972 compared to placebo in subjects~     with Type 2 Diabetes Mellitus (T2DM)~   "
54635|NCT02851836|"~     this study aims to validate a picture data set that particularly activates the attachment~     process and that could be used in attachment studies.~   "
54636|NCT02851823|"~     The aim of the present study was to compare the effectiveness of combined Er:YAG and Nd:YAG~     laser therapy to that of scaling and root planning with hand instruments in nonsurgical~     treatment of chronic periodontitis.~   "
54637|NCT02851810|"~     The study aims to identify specific visual scanning patterns of attachment pictures in~     adolescent with different attachment style.~   "
54640|NCT02851771|"~     A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the~     diagnosis in less than two hours of pneumonia caused by known pathogens, close to the~     reception of Emergency service. In this instance 30% of patients have no etiological~     diagnosis after the POC tests Pneumonia. This lab has discovered over 200 new species of~     bacteria in humans, including vector bacteria and opened the field of large Deoxyribo Nucleic~     Acid (DNA ) viruses. Also, the laboratory of emerging viruses discovered many Ribo Nucleic~     Acid (RNA) viruses transmitted by arthropods. Based on this collection of new pathogens~     described in POC laboratory, this study proposes to expand the etiological diagnosis strategy~     of pneumonia after POC tests.~   "
54641|NCT02851758|"~     The investigators propose a robust therapeutic intervention to ameliorate myocardial~     ischemia/ reperfusion injury and significantly decrease morbidity and mortality in patients~     requiring extracorporeal membrane oxygenation (ECMO), by direct injection of autogeneic~     mitochondria into the ischemic myocardium.~   "
54642|NCT02851745|"~     The primary objective of the study is to evaluate the effect of linagliptin 5 mg daily versus~     the corresponding placebo on the LV systolic function (measured by midwall shortening~     analysis) in patients with T2DM and a documented baseline concentric LV geometry and LV~     systolic dysfunction.~   "
54643|NCT02851732|"~     The purpose of the study is assess the impact of and educational multifaceted intervention in~     adherence to evidence based thearapies prescription (according to local guidelines) for~     cardiovascular prevention in high risk patients for (lipid lowering agents, antiplatelets and~     ACE Inhibitors) in 12 months.~   "
54644|NCT02851719|"~     To test whether biofeedback (BF) added to pelvic floor muscle training (PFMT) promotes~     additional benefits over PFMT alone in the stress urinary incontinence (SUI) treatment.~   "
54645|NCT02851706|"~     Background:~      Brain and spinal cord tumors are uncommon. But they contribute substantially to cancer deaths~     in the U.S. in children and adults. Little progress has been made in treating brain tumors.~     Researchers want to learn more about these tumors by studying people who have them.~      Objectives:~      To understand brain and spinal cord tumors better and uncover areas for further research.~     Also, to connect people with these tumors to doctors who can help them manage their illness~     and give them new treatment options.~      Eligibility:~      People ages 3 and older who have been diagnosed with a tumor of the brain or spinal cord.~      Design:~      Participants will have an initial (baseline) visit. They will have their medical history~     taken and undergo physical and neurological exams. They will have blood tests. They may have~     scans (imaging studies) of the nervous system.~      If participants have urine or cerebrospinal fluid collected during their regular care,~     researchers may save some.~      Brain tumor tissue from a prior surgery may be studied.~      Genomic DNA testing will be done on samples. Results will be linked to participants medical~     and/or family history.~      The number of study visits at NIH will depend on the wishes of participants and their local~     doctors.~      Participants will take a brain tumor survey on a computer. They can take it all at once or in~     6 separate sections.~      Participants will answer questions about their general well-being. They will answer questions~     to learn if they have symptoms of depression or anxiety.~      Physicians will discuss test results with participants. They will recommend management and~     treatment options.~   "
54646|NCT02851693|"~     The diagnosis of cutaneous lesions often involves the use of surgical and invasive procedures~     such as biopsy or excision in order to analyze the structure and appearance of the fabric~     pathologists. With recent advances in optical and electronic fields, considerable efforts~     were produced to build high-performance optical instruments, able to transcribe the internal~     structure of the skin with varying degrees of depth and variable resolution.~      The imagery is now an area of great interest for medical diagnosis: non-invasive, quick, and~     in real time. This area is booming and new optical instruments are created to eventually be~     able to offer a reliable alternative to invasive techniques.~      The optical properties of different tissues have been studied for several years by different~     research groups: the coefficient of light absorption by the tissue both in vivo and in vitro,~     the coefficient of light scattering or the index refractive were characterized in various~     tissues that make up the skin.~      Other studies have focused on melanoma detection by multispectral optical techniques, or via~     the technique of optical coherence tomography (OCT) performed on lesions suspicious for~     cancer, but without linking criteria between these two techniques.~      However, no study to date and to our knowledge has been able to demonstrate the different~     optical parameters obtained with OCT and can be directly connected to known and~     histopathological parameters commonly used in the diagnosis of lesions skin. This study aims~     to verify if it is possible to determine the parameters measured in OCT that would~     discriminate between benign and malignant lesions.~   "
54647|NCT02851680|"~     In the context of screening for infectious fungal diseases in patients with malignant~     haemopathy, and particularly patients with acute leukaemia, the investigator aims to evaluate~     the performance of an already commercialized but little used serum screening test (Fungitell®~     test) and to determine its place in the management strategy for invasive aspergillosis.~   "
54648|NCT02851667|"~     According to the Social Welfare Department statistics, Kwun Tong has been ranked as the~     highest for the reported cases of elderly abuse (12.3%), the second and fourth highest for~     the reported cases of battered spouse (9.2%) and child abuse (7.9%) respectively. To~     strengthen family well-being in the Kwun Tong community, the investigators adopt a~     community-based participatory (CBP) approach and implement a community-based Learning~     Family campaign in Kwun Tong district with the investigators collaborator, the Christian~     Family Service Centre (CFSC). The campaign aims to promote family health, happiness, and~     harmony (3Hs) through cultivating cooperative and self-regulated family learning culture in~     Kwun Tong district.~   "
54666|NCT02851433|"~     Heart surgery is a considerable source of stress for the myocardium that must be minimized.~      Troponin Ic is a reliable marker to determine the level of this myocardial stress.~      Studies have shown that post-conditioning with AVH has a protective effect on the myocardium,~     if the treatment is initiated at the start of the ischemia.~      The aim of this study is to evaluate the protective effect on the myocardium (by measuring~     troponin levels) of the association of pre-conditioning and post-conditioning with~     Sevoflurane (AVH) sedation administered during and after scheduled surgery for valve~     replacement, via sternotomy or thoracotomy compared with total intravenous anaesthesia with~     Propofol.~   "
54649|NCT02851654|"~     Dry eye syndrome is a benign situation however its impact on patient's quality of live and on~     health system is not trivial. One problem is the lack of correlation between patient's~     symptoms and physical sign observed on slit lamp examination. Eye blinking is a parameter of~     increased interest in this pathology particularly its frequency. To date no treatment of dry~     eye syndrome has a proven impact on eye blinking frequency. However recording of blinks has~     mostly been performed on short duration (3 to 5 minutes) and the distribution of intervals~     between 2 blinks is not gaussian but exponential. In this study, it is proposed to use modern~     eye-movement recorder to measure the blink frequency on longer duration (12 minutes) while~     reading on a screen computer and during a face-to-face interview before and after treatment~     of meibomian gland dysfunction responsible of moderate to severe dry eye syndrome.~   "
54650|NCT02851641|"~     The aim of the study is to evaluate the risk in intra-operative nasal hemorrhage when using a~     pushed probe (Master Ka) in the treatment of naso lacrimal duct obstruction (NLDO).~      In the investigator's experience, this risk seemed to minus using a pushed probe rather than~     the classical pulled-type probes.~      A lower risk of hemorrhage could lead to a change in the anesthetic procedure. The gold~     standard in NLDO is the use of an orotracheal intubation. It could then be replaced by the~     use of an orolaryngeal mask. A forthcoming study will evaluate the results of this anesthetic~     change.~   "
54651|NCT02851628|"~     The investigation is a prospective non-blinded and semi-randomized clinical investigation.~     The investigation is designed to assess the alternative sizing model which the trial mask~     concept is based on and how it compares to a conventional sizing present in the Prototype~     Full Face Mask (PFFM) mask.~   "
54652|NCT02851615|"~     The objective of this study is to determine the feasibility and acceptability of SCThrive, a~     an innovative, technology-enhanced, group self-management intervention that uses a mixed~     in-person and online format and supported by a tailored mHealth tool, iManage. The study will~     also evaluate the initial efficacy of SCThrive for increasing behavioral activation (BA) in~     adolescents with Sickle Cell Disease (SCD) ages 13 to 21. The investigators hypothesize that~     participants in the SCThrive group will show greater BA (primary outcome) at post-treatment~     than the attention control group, and that participants in the SCThrive group will continue~     to show significantly greater BA at the six week follow-up compared to the attention control~     group. Investigators will also explore whether SCThrive is associated with greater~     improvements in self-management behaviors and quality of life (secondary outcome) compared to~     attention control at the six-week follow-up assessment.~   "
54653|NCT02851602|"~     HDL in obese non-diabetic patients show major alterations in their function and thus their~     cardio-protective effects. These alterations could be explained by the quantitative and~     qualitative anomalies in the phospholipids and sphingolipids in the HDL. These molecules play~     a major role in HDL function and probably present early modifications in obesity, even before~     the onset of glycaemia deregulation.~      The aim of this study is to show the presence of qualitative and quantitative modifications~     of phospholipids and sphingolipids in HDL from obese patients compared with HDL from~     non-obese controls.~   "
54654|NCT02851589|"~     The purpose of this study is to evaluate the safety and effectiveness of CAR-T cell~     immunotherapy in patients with CD19 positive relapsed or refractory Leukemia and Lymphoma.~   "
54655|NCT02851576|"~     Fourteen patients will be included for infusion of adenovirus-specific T-cells generated by a~     clinical grade IFN-γ based immunomagnetic isolation from a leukapheresis from their original~     donor or a haploidentical donor, in case of Umbilical cord blood transplantation, in the~     event of refractory ADV infection or disease.~   "
54656|NCT02851563|"~     The purpose of this study is to learn more about the natural history of Canavan disease~   "
54657|NCT02851550|"~     Lysosomal Acid Lipase (LAL) deficiency is a rare, autosomal recessive storage disease linked~     to decrease enzymatic activity of LAL, responsible for intracellular accumulation of~     cholesterol esters and triglycerides.~      The accumulation of lipid is in hepatocytes, Kupffer cells and macrophages leading to a fatty~     liver, hepatic fibrosis that can evolve up to cirrhosis.~      LAL deficiency is responsible for significant morbidity and early mortality in children,~     adolescents and adults in connection with a multi visceral disease reaching the liver,~     gastrointestinal tract and the vascular endothelium. The disease is caused by homozygous or~     heterozygous mutations in the gene (LIPA chromosome 10q23.2-23.3) which is responsible for~     the synthesis of the LAL.~      The disease can be diagnosed by enzymatic analysis using few drops of blood absorbed onto~     blotting paper.~      Patients with this deficiency LAL, have no or reduced activity of this enzyme. Because of its~     rarity, the deficit in LAL is under diagnosed or is diagnosed in patients with liver~     biological disturbances and / or lipid profile disturbances, steatohepatitis-hepatitis~     (NASH), the steatosis (NAFLD), the cryptogenic cirrhosis or Wilson disease.~      Inclusion period of 12 to 18 months (100 patients).~   "
54658|NCT02851537|"~     EPIRMEX is a complementary study to the national cohort EPIPAGE 2 the INSERM Unit 953 is~     responsible. The objective of this study is to evaluate at the age of 5 years corrected~     executive functions in children born very prematurely in relation to structural brain~     abnormalities in magnetic resonance imaging (MRI) (technical conventional and advanced)~     performed at the age of term. The current study is a project on a subset of the population of~     premature EPIRMEX subjects who had an advanced technique as magnetic resonance spectroscopy~     (MRS). It is a recent imaging technique for a study of the cerebral metabolism. It is based~     on the detection of cerebral metabolites, and the variations of their concentration to~     characterize different pathologies. In most cases, combinations of metabolites are informed~     creatine + phosphocreatine (CR), glycerophosphocholine + phosphocholine (CHO) +~     Nacétylaspartate Nacetylaspartylglutamate (NAA), myoinositol (INS) and lactate (LAC). In the~     premature newborn, the NAA / CHO ratio increases with age in all brain regions. The LAC / NAA~     ratio decreases significantly with age in the thalamus, basal ganglia, the corticospinal~     tract, and parietal white matter tends to decrease elsewhere . A number of studies show that~     proton spectroscopy term can predict the long-term newborn who presented an anoxic-ischemic~     encephalopathy .These studies indicate that an increase in lactate and a decrease in NAA are~     correlated with abnormal neurological development. And decreases in NAA / CR and / or NAA /~     CHO ratios are predictive of motor abnormalities in children with anoxic encephalopathy~     presented an ischemia . These decreases were also measured in the basal ganglia, occipital~     cortex, and areas near the last. Few studies have explored the magnetic resonance~     spectroscopy of proton-term prediction of the future of large premature.~   "
54681|NCT02851238|"~     This study aims to prove that driving pressure limited ventilation is superior in preventing~     postoperative pulmonary complications to existing protective ventilation.~   "
54861|NCT02848885|"~     This is a novel study that seeks to explore the clinical and functional imaging effects of~     transcranial direct current stimulation (tDCS) on illness awareness or anosognosia in~     schizophrenia, arguably the most treatment-resistant manifestation of the disorder.~   "
54659|NCT02851524|"~     Falls in the elderly population are a major public health problem because of their frequency~     and their consequences, notably in terms of dependence their cost to society. In most cases,~     balance disorders related to an impaired vestibular system are blamed, even though there is~     no formal evidence that this is the case.~      Vestibular tests in routine otoneurological practice are based on the exploration of~     vestibulo-ocular or even vestibulo-cortical reflexes. They are not particularly suitable to~     screen for vestibular disorders in falls.~      A prototype rocking chair has been developed to test psycho-vestibular pathways, defined as~     the pathways via which vestibular afferents are transported to the subject's conscience.~     Thanks to this apparatus, a stimulus of body movement will be generated, but with limited~     tactile, visual and proprioceptive afferents, in such a way that the vestibular system alone~     is able to indicate to subjects their position in space. The subject will be required to~     detect oscillatory movement, and then to distinguish between a vestibular stimulus and a~     pulsed auditory stimulus.~      The study hypothesis is that the movement stimulation generated by our prototype will be~     sufficient to stimulate the vestibular system, which will manifest itself as a conscious~     sensation of movement and by a vestibulo-ocular reflex causing oculomotor manifestations.~   "
54660|NCT02851511|"~     A two-phase adaptive randomized clinical trial will examine the individual and combined~     impact of pairing cognitive training with transcranial direct current stimulation (tDCS).~     tDCS is a method of non-invasive brain stimulation that directly stimulates brain regions~     involved in active cognitive function and could enhance neural plasticity when paired with a~     training task. We will compare changes in cognitive and brain function resulting from CT and~     ET combined with tDCS using a comprehensive neurocognitive, clinical, and multimodal~     neuroimaging assessment of brain structure, function, and metabolic state. Functional~     magnetic resonance imaging (FMRI) will be used to assess brain response during working~     memory, attention, and memory encoding; the active cognitive abilities trained by CT. Proton~     magnetic resonance spectroscopy (MRS) will assess cerebral metabolites, including GABA~     concentrations sensitive to neural plasticity. We hypothesize that: 1) tDCS will enhance~     neurocognitive function, brain function, and functional outcomes from CT, with combined CT~     and tDCS providing the most benefit; 2) Effects of tDCS on CT will be maintained up to 12~     months following training, and 3) Neuroimaging biomarkers of cerebral metabolism, neural~     plasticity (GABA concentrations) and functional brain response (FMRI) during resting vs.~     active cognitive tasks will predict individual response to tDCS.~   "
54661|NCT02851498|"~     This controlled weight loss trial in adults at cardiometabolic risk (elevated~     triglyceride/HDL ratio) followed a randomized, cross-over design and utilized novel,~     high-protein pasta and cereal to examine the physiological impact of stealth substitution of~     dietary carbohydrate with protein derived from soy concentrates, wheat protein isolates, and~     dried egg whites. Pasta dishes were prepared using high-protein orzo and fusilli pasta (Zone~     PastaRxTM) or conventional, gluten-free pasta, and high-protein flaked cereal (ZoneTM cereal)~     was matched with conventional flaked cereal. Participants were instructed to follow an energy~     restricted diet (-500 kcal/d) and incorporate a test food into each of three meals over a~     24-hour period. The diet-induced changes in body mass and lean body mass were tracked as well~     as changes in in insulin sensitivity and common blood biomarkers.~   "
54662|NCT02851485|"~     This is an open-label study to determine the pharmacokinetics of a new tablet formulation of~     GLPG1972 and to compare it with this of the liquid solution used during the First-in-Human~     study (GLPG1972-CL-101). The impact of food intake on the oral bioavailability of GLPG1972~     administered as tablet will also be investigated in this study. A dose of 600 mg has been~     selected. The study is a phase I randomized open-label cross-over study with three single~     dose treatments:~      A) 600 mg GLPG1972 oral solution after overnight fast,~      B) 600 mg GLPG1972 oral tablet after overnight fast,~      C) 600 mg GLPG1972 oral tablet 30 minutes after high-fat high-calorie breakfast.~      A washout of at least 6 days between subsequent dosing days is respected so that no~     measurable plasma levels or biologically significant effects are remaining. There will be~     frequent assessment of adverse experiences post-dose. Twelve healthy male subjects will be~     selected according to the inclusion and exclusion criteria and 2 subjects each will be~     randomized to one of the 6 treatment sequences (ABC, ACB, BAC, BCA, CAB, CBA)~   "
54663|NCT02851472|"~     The investigators seek to determine whether providing inhaled nitric oxide (iNO; a~     vasodilator) will improve the delivery of oxygen to the brain, kidney and intestines of~     preterm neonates during and after the subject receives a packed red blood cell transfusion~     (PRBC) for anemia vs. baseline period. The investigators will observe the effect of inhaled~     nitric oxide vs. placebo at these body sites to determine whether iNO will alter the~     fractional tissue oxygen extraction. Treatment and control groups will be compared to each~     other at equivalent epochs as will individual patients before, during and after the PRBC~     transfusion.~   "
54664|NCT02851459|"~     This study is the first phase of a trial examining decision making about vaccines. This phase~     tests the impact of targeted vaccine-focused health messages on vaccine beliefs held by~     parents of young children and pre-adolescents. The participant's vaccine beliefs will be~     assessed at baseline. Two weeks later, the participant's moral matrix will be assessed. A~     vaccine-related message that appeals to the individual's three most or least emphasized moral~     foundations will then be presented. Immediately afterwards, vaccine beliefs will be assessed~     to determine the impact of the message.~   "
54665|NCT02851446|"~     Non-invasive nocturnal ventilation is an effective treatment for chronic respiratory failure,~     whether due to obstructive (COPD), restrictive or neuromuscular causes, notably for patients~     in the last two categories for whom it significantly prolongs life expectancy. Overall, the~     treatment is well tolerated, its principal adverse effects being discomfort related to the~     mask.~      In certain patients, morning dyspnoea when the mask is removed has been described. This is~     disabling as it limits everyday activities for at least 30 minutes, and defines deventilation~     syndrome. The pathophysiology of this syndrome is uncertain, notably the roles of~     hyperinflation, patient/ventilator asynchrony, or the sudden increase in diaphragmatic work~     after a night of rest.~      The aim of this study is to investigate the prevalence of and factors associated with~     reventilation syndrome (DS) in a population of patients with ventilation whatever the reason,~     in a stable state, and followed by the medical devices department of Dijon CHU, so as to~     better understand the mechanisms. Patients with DS will subsequently be invited to~     participate in a therapeutic trial.~   "
54667|NCT02851420|"~     The detection of suspect lesions is based on the clinical examination of the oral cavity and~     pharyngolaryngeal endoscopy, but the examination to confirm the diagnosis is a pathology~     examination of the biopsy taken during the endoscopy. Taking the biopsy, however, can be~     difficult. On the one hand , it is an invasive procedure, and may engender complications, and~     on the other hand, certain modifications of the mucosa may be discrete, or not particularly~     specific or, on the contrary, disseminated or extremely widespread.~      Non-invasive tools to help the diagnosis could prove to be particularly interesting 1) to~     restrict the use of biopsies to patients in whom it is really necessary 2) and to identify~     the area where the biopsy should be done in cases of multiple lesions. In this context,~     spectroscopy could be a promising alternative.~      The investigator puts forward the hypothesis that cancerous and precancerous lesions of the~     mucosa of the upper airways and digestive tract present a characteristic spectrometric~     profile. Indeed, as malignant tumours are hypervascularized and as precancerous tumours show~     signs of angiogenesis, investigators expect that the reflectance of haemoglobin will be~     diminished in the specific wavelengths of 540 and 575 nm, corresponding to the principal~     wavelengths absorbed by haemoglobin.~      This pilot study will make it possible to construct an algorithm that could be used to~     classify lesions of the upper airways and digestive tract as either seemingly benign or~     cancerous.~   "
54668|NCT02851407|"~     This study is to compare the efficacy and safety of defibrotide prophylaxis in addition to~     best supportive care versus best supportive care alone in the prevention of hepatic veno-~     occlusive disease (VOD) in adult and pediatric patients undergoing hematopoietic stem cell~     transplant who are at high risk or very high risk of developing VOD.~   "
54669|NCT02851394|"~     Sternotomy, the reference approach for heart surgery, may induce profound and intense~     post-operative pain. One method of analgesia used is patient-controlled intravenous morphine.~      The analgesic efficacy of continuous wound infiltration at the sternum following heart~     surgery has been demonstrated.~      The analgesic catheter placed near the sternotomy wound reduces the consumption of morphine.~      The aim of this study is to determine whether a bolus of tramadol associated with the~     continuous administration of levobupivacaine via the wound catheter could potentiate the~     local anaesthetic effects, thus leading to a decreased consumption of postoperative~     intravenous morphine, and a decrease in morphine-related side effects.~   "
54670|NCT02851381|"~     Single compassionate use subject is an 83 year old woman with a history of lymph node~     positive breast cancer and recently diagnosed pancreatic cancer in May. With an Eastern~     Cooperative Oncology Group (ECOG) of 2, it is felt that she cannot tolerate more aggressive~     chemotherapy. The investigators propose to administer FG-3019 on a compassionate pleas basis~     in combination with gemzar. The patient is currently being treated and is tolerating gemzar.~   "
54671|NCT02851368|"~     This research study will evaluate how Near Infrared Fluorescence imaging (NIFI) with~     indocyanine green (ICG) contrast dye can assist in the identification and diagnosis of lung~     nodules during surgery. NIFI is an intraoperative imaging technology that utilizes a coupled~     camera/fluorophore (ICG) system to fluoresce tissues of interest. Intravenous ICG is a~     fluorophore with a long-standing high safety profile.~   "
54672|NCT02851355|"~     Clinical follow-up survey of the Norwegian material of paediatric patients who received~     therapy for medulloblastoma and CNS-PNET from 1974 - 2013 with a focus on quality of life,~     education, work, family and children, delayed effects of tumour disease and treatment,~     endocrine evaluation, existence of auditory neuropathy, and neuropsychological testing.~   "
54673|NCT02851342|"~     In this study, 100 persons with Multiple Sclerosis and 50 matched controls will be examined~     with magnetoencephalography (MEG), magnetic resonance imaging (MRI) and cognitive tests. The~     primary hypothesis for the study is: Interhemispheric connectivity, determined using graph~     theoretic analysis (GTA) on source-reconstructed MEG data, is a biomarker for cognitive~     deterioration in MS, which has value at the individual patient level.~   "
54674|NCT02851329|"~     The investigators propose a non-invasive prognostic tool for TKIs resistance in patients with~     stage IV EGFR-mutant non-small cell lung cancer (NSCLC) by computed tomography phenotypic~     features, which can be conveniently translated to facilitate the pre-therapy individualized~     management of EGFR TKIs in this disease.~   "
54675|NCT02851316|"~     Whole body vibration (WBV) acutely improves quadriceps strength, and may improve long-term~     outcomes in individuals with anterior cruciate ligament reconstruction (ACLR). However, it is~     unclear if WBV influences athletic tasks such as running. The purpose of this study is to~     evaluate the influence of WBV on running biomechanics in individuals with ACLR.~   "
54676|NCT02851303|"~     This study investigates the use of methadone versus morphine wean for the treatment of~     neonatal abstinence syndrome for infants exposed to opioids in utero. Half of infants who~     require pharmacotherapy for NAS will receive a methadone wean, and half will receive a~     morphine wean. Length of hospital stay, length of treatment and parent satisfaction will be~     studied.~   "
54677|NCT02851290|"~     Hypospadias is one of the most common genitourinary (GU) malformations, seen in approximately~     1 of 250 male live births. Common methods of local anesthesia administration for hypospadias~     surgery include caudal and dorsal penile nerve blocks. While both methods are known to be~     effective with minimal risk, the effect on post-operative complications is not~     well-established. The purpose of this randomized controlled trial is to evaluate if caudal~     versus dorsal penile nerve block results in higher rates of post-operative complications.~   "
54678|NCT02851277|"~     The purpose of this study is to evaluate the safety and tolerability of ASP0892 after~     intradermal or intramuscular injection in adults with peanut allergy.~   "
54679|NCT02851264|"~     The aims of the present study：~        1. To investigate the diagnosing value of optical enhancement technology for early~          esophageal squamous neoplasia.~        2. To assess the detection rate of early esophageal squamous neoplasia by virtual~          chromoendoscopy with optical enhancement technology .~   "
54680|NCT02851251|"~     These exams are vital to protect healthy neonates from blindness. The purpose of this study~     is to better screen ocular disease in otherwise healthy neonates using wide-field digital~     imaging system (RetCam III) in a multi-center network in China leaded by Xinhua Hospital~     Affiliated to Shanghai Jiao Tong University School of Medicine. The multi-center network will~     be built with the collaboration of eight hospitals from different parts of China.~   "
54682|NCT02851225|"~     Currently the Toulouse University Hospital, the organization of transfusion care for patients~     requiring regular transfusions is based on reading the biological results received by fax~     before confirming or disproving a planned hospitalization or program a new hospital if~     needed.~      Remote transmission of laboratory results, replacing fax communication might facilitate the~     coordination of care that results from these laboratory results and provide a better respect~     of the Plan Custom Care Transfusion (PPST).~      The investigators offer organization of transfusion supportive care for patients with~     conditions requiring biological monitoring using the techniques of information and~     communication telemedicine.~      Primary objective~      - Assess the feasibility of setting up an upload procedure biological results in the~     treatment of transfusion supportive care.~      Secondary objectives~        -  Assess the evolution of the quality of life of patients during the treatment~        -  Assess changes in patient satisfaction over the support~        -  Assess the evolution of the satisfaction of the medical team at home and at Toulouse~          University Hospital~        -  Describe the programming time (hospitalization, consultations)~        -  Estimate the loss of biological results~        -  Assessment of the descriptive use of hospitalization, consultation and biological~          examinations in both groups. This remedy shall be valued in Euros thanks to GHS rates~          for hospitalizations, NGAP rates for consultations and biology of nomenclature (NABM)~          for biological tests.~   "
54683|NCT02851212|"~     The purpose of this study is to evaluate bioequivalence of the metformin component of the~     Fixed Dose Combination (FDC) tablet compared with the metformin Extended Release (XR) tablet~     coadministered with canagliflozin in healthy fed and fasted participants.~   "
54684|NCT02851199|"~     Electroencephalograhy (EEG) is used as a tool for diagnosing epilepsy/convulsions.~      During the recording, especially for childen who are suspected of having abbcence epilepsy~     the investigators will perform an EEG recording including a provocation test of~     hyperventilation in order to induce epileptic discharges.~      There is no clear instruction about the position of the child during performing this~     hyperventilation provocation.~      Clinical observations showed that this provocation is more effective when it's performed in~     the siiting position.~      No study was previously performed to investigate this issue~   "
54685|NCT02851186|"~     Objectives:~      To examine the efficacy and safety of electroacupuncture (EA) combined with auricular~     acupuncture (AA) in reducing post-operative pain in patients following abdominal surgery for~     gynecological diseases.~      Hypothesis:~      Acupuncture is effective and safe to reduce postoperative pain during the first 5 days~     following surgery as compared to a sham control.~      Design and strategy:~      This is a randomized, placebo-controlled, subject- and assessor-blind trial. Seventy-two~     subjects will be recruited and randomized (in 1:1 ratio) to receive either acupuncture~     treatment or sham control. Subjects in both groups will undergo standard operation procedure~     and receive post-operative analgesics based on usual care.~      Study instrument:~      A 10-point pain Numerical Rating Scale (NRS) will be employed as a primary outcome~     assessment.~      Intervention:~      Subjects in the treatment group will receive EA combined with AA within two hours before~     operation, post-operation upon arrival to the ward and once a day for the subsequent 5 days.~     Subjects in the control group will receive non-invasive sham procedure in the same schedule.~      Main outcome measures:~      Primary outcome: NRS pain scores will be measured upon recovery, hourly at 6 hours after~     surgery, then 4-hourly until day 2, 6-hourly until day 3 and once daily until discharge.~      Secondary outcome:~      Morphine consumption, post-operative syndromes, quality of recovery questionnaire, SF-6D,~     EQ-5D-5L and adverse events will be documented and compared between groups.~      Data analysis: Pain intensity during the first 5 days will be calculated by Area Under the~     Curve (AUC) of NRS pain scores. AUC between the two groups will be compared by Student's~     T-test.~      Expected outcome: AUC of the acupuncture group is expected to be significantly lower than~     sham acupuncture group.~   "
54686|NCT02851173|"~     This is a mechanism-driven translational project to test the efficacy of transcranial~     low-level light/laser therapy (LLLT), for enhancing cognitive function in middle-aged and~     older adults and participants with Mild Cognitive Impairment.~   "
54687|NCT02851160|"~     Qualitative study on data from interviews such patients, relatives and doctors involved in~     the implementation of cancer care. Framework type of method using grounded theory~   "
54688|NCT02851147|"~     The purpose of the evaluation is to confirm operability and usability of the SL-D301 Slit~     Lamp and the DC-4 digital camera attachment by conducting a usability evaluation and~     subsequently submitting a questionnaire and hold an interview with the operator.~      Of special interest for the study is to confirm whether the illumination level of SL-D301 is~     enough to perform an eye exam since the maximum illumination level on the SL-D301 is lower~     than other existing Topcon digital ready slit lamps due to regulations that limit the maximum~     light intensity on the human eye. The SL-D301 will be compared against the predicate device~     SL-3G.~   "
54689|NCT02851134|"~     This study highlight genetics mutations with major effect in Crohn's Disease (CD) by WES in~     individuals affected and healthy individuals from EPIMAD Inserm InVS registry families.~   "
54690|NCT02851121|"~     The main goal of this study is to better understand the link between motor system (action)~     and perception in variable sensorial forms by examining the time course and the dynamic of~     electroencephalography (EEG) activations. To do so, differents sensimotor study protocols in~     linguistics and in the fiels of emotional and spatial perception will be realised in order to~     study prcisely differents links parception-action.~   "
54691|NCT02851108|"~     Safety of artesunate-amodiaquine combined with methylene blue or primaquine for falciparum~     malaria treatment in African children: A randomised controlled trial~      Elimination has become the goal of malaria programmes in an increasing number of endemic~     countries and regions. As resistance against artemisinin compounds has recently started to~     emerge in South-East Asia, there is a clear need to develop alternative malaria drug~     combinations. Adding another anti-malarial with a short half-life such as methylene blue to~     standard ACT could be a strategy to prevent artemisinin resistance development. Moreover,~     adding a gametocytocidal drug to ACT reduces the probability of transmission of P. falciparum~     parasites including drug-resistant parasites.~      Objectives: The primary objective of this trial is to investigate the safety of artesunate~     (AS) - amodiaquine (AQ) - methylene blue (MB) compared to AS - AQ - primaquine (PQ) in young~     children with uncomplicated falciparum malaria in Burkina Faso.~   "
54692|NCT02851095|"~     The purpose of this study is to evaluate bioequivalence of the metformin component of the~     Fixed Dose Combination (FDC) tablet compared with the metformin Extended Release (XR) tablets~     co-administered with canagliflozin in healthy fed and fasted participants.~   "
54705|NCT02850926|"~     This study will determine if protective soccer headgear reduces the incidence or severity of~     Sport Related Concussion injuries (SRCs) in US adolescent (high school) soccer players. Half~     the subjects will practice and play during their soccer season with soccer head gear~     specifically marketed to reduce the incidence of SRCs while the other half of the subjects~     will practice and play without the head gear.~   "
54693|NCT02851082|"~     Physical activity is lower in patients with haemophilia than in their healthy peers.~     Nevertheless, exercize is recommended for those patients and supported by evidence. Until~     2013, scientific and medical evidence to encourage physical activity for patients with~     haemophilia were listed to increase their locomotor function, their metabolic status, their~     fitness level and their well-being. In 2013, an original publication by Groen et al.~     suggested that physical activity could also interact with the specific and biological~     disturbance of the disease.~      We propose to consider that regular endurance exercize prescription should be encouraged in~     patients with haemophilia not only for a healthier lifestyle but also because it could~     positively alter the specific biological blood disturbance seen in haemophilia. Nevertheless,~     before planning a well powered intervention trial we need to determine the acceptability of~     regular exercize and the expected value of factor Factor VIII, von Willebrand factor and von~     Willebrand propeptide after an endurance training program.~   "
54694|NCT02851069|"~     The interferon-free combination regimen of Paritaprevir/r - Ombitasvir with or without~     Dasabuvir (ABBVIE REGIMEN) ± Ribavirin (RBV) for the treatment of chronic hepatitis C (CHC)~     has been shown to be safe and effective in randomized controlled clinical trials with strict~     inclusion and exclusion criteria under well controlled conditions.~      This observational study is the first effectiveness research examining the ABBVIE REGIMEN ±~     RBV, used according to local label, under real world conditions in Israel in a clinical~     practice patient population.~   "
54695|NCT02851056|"~     The purpose of this study is to test what effects (good and bad) a new cancer vaccine will~     have on participants and their cancer, when administered before and after their autologous~     hematopoietic cell transplant (HCT).~      The name of the vaccine is called Dendritic Cell Survivin Vaccine (DC:AdmS). The vaccine is~     made using the participant's own blood cells. The vaccine will contain a virus called an~     adenovirus, similar the virus that causes the common cold. The virus has been changed so it~     cannot infect humans and cause infections. The vaccine will be prepared at Moffitt Cancer~     Center in the Cell Therapy Laboratory Facility.~   "
54696|NCT02851043|"~     This study will clinically evaluate a newly developed respiratory monitor - pneuRIP. The~     pneuRIP uses Respiratory Inductance Plethysmography (RIP) bands to measure key breathing~     indices non-invasively. This study compares the pneuRIP to an existing Respitrace system~     (Carefusion, Yorba Linda CA). 10 normal children and 10 children with breathing difficulties~     will be monitored with both systems.~   "
54697|NCT02851030|"~     Increasing physical activity (PA) and limiting sedentary time are important for many aspects~     of a young child's wellbeing. However, young children's PA is often limited, and instead~     preschoolers (3-5 year olds) spend a large portion of their day inactive. Given that more~     than 7 million U.S. children younger than 5 attend center-based child care, the early care~     and education (ECE) setting is an important source of PA for young children. Thus, PA~     promotion efforts in ECE programs are crucial to increasing the activity levels of young~     children, although few interventions exist and most have limited success.~      Classroom teachers are important gatekeepers to physical activity in ECE classrooms, as they~     can determine how active children are in their care. However, teachers often hesitate to~     implement physical activity in their classrooms. Teachers' attitudes about PA, confidence in~     modifying children's PA, and their own physical abilities can influence the amount of~     activity they provide and how they interact with children to support PA. Few models exist to~     enhance teachers' skill in promoting children's activity, although such an approach could~     result in more sustainable outcomes. Innovative approaches to physical activity promotion are~     needed, which engage teachers through training, ongoing technical assistance, and easy-to-use~     resources.~      This project aims to improve children's physical activity through the Move, Play, Learn!~     intervention, an intervention designed to alter the behavior of classroom teachers to~     increase PA in children (3-5 years old) enrolled in ECE programs through a novel, behavioral~     coaching approach.~      To evaluate the 10-week intervention, 32 classrooms in ECE centers will be recruited and~     randomly assigned to the Move, Play, Learn! intervention or a waitlist control. Teachers in~     the intervention arm will attend training workshops to learn how children's activity can be~     increased using natural opportunities across the child care day and how teacher engagement~     with children can impact activity outcomes. Teachers will be asked to modify typical~     classroom activities to be more active, using strategies and resources (e.g., how-to videos,~     pocket activity cards) and will be asked to modify their interactions with children to~     support PA. Goal setting, self-monitoring, and tailored feedback will facilitate behavior~     change.~   "
54698|NCT02851017|"~     Balance training is an important component of physical fitness, however due to the mundane~     and often repetitive nature of balance training alone this is often forgotten about and as a~     result people may be more susceptible to postural control instabilities. A potential solution~     to the mundane aspect of balance training is the use of exergaming (interactive exercise and~     gaming combined) through the use of commercial gaming systems such as the Nintendo Wii, Dance~     Dance Revolution (DDR) and more recently the XBOX Kinect. The aim of the investigation was to~     assess the XBOX Kinect versus traditional balance training on postural control, flow and~     technology acceptance.~   "
54699|NCT02851004|"~     the efficacy and safety of BBI608 in combination with pembrolizumab~   "
54700|NCT02850991|"~     Definitive chemoradiation is the standard treatment for locally advanced esophageal cancer.~     NCCN (National Comprehensive Cancer Network) recommends radiation dose of 50-50.4 Gy as the~     definitive radiation dose for esophageal cancer with definitive chemo-radiation. However, as~     many studies in China showed that the most common recurrence site after definitive~     chemo-radiation was within the radiation region. But there have not been large randomized~     clinical trials to investigate the optimal radiation dose with concurrent chemotherapy for~     esophageal cancer in China. The purpose of this clinical trial is to investigate the optimal~     radiation dose for thoracic esophageal squamous cell cancer with definitive concurrent~     chemoradiotherapy.~   "
54701|NCT02850978|"~     Study to assess the long-term safety and effectiveness of Spilolto in Japanese patients with~     COPD in real-world setting~   "
54702|NCT02850965|"~     To evaluate the efficacy and to compare efficacy and safety of BI 695501 versus Humira in~     patients with moderate to severe chronic plaque psoriasis.~   "
54703|NCT02850952|"~     To determine whether implementation of Rehab MATRIX will improve patient safety, patient~     satisfaction and nursing indices.~   "
54704|NCT02850939|"~     Adjuvant endocrine hormonal therapy (EHT) is highly effective and appropriate for nearly all~     breast cancer patients with hormone receptor-positive tumors, which represent 75% of all~     breast cancer diagnoses. Long-term use of EHT reduces cancer recurrence rates and cuts the~     risk of death nearly in half during the second decade after diagnosis, research shows.~     Despite the proven benefits, about 33% of women who are prescribed EHT do not take their~     medication as prescribed (less than 80% take their daily dosage) and are thus at higher risk~     of recurrence and death.~      This educational randomized controlled study will develop and pilot-test a bilingual,~     culturally tailored, personalized, interactive mobile application (app) in combination with~     patient navigation to promote and improve adherence to endocrine hormonal therapy (EHT) among~     breast cancer patients.~   "
54706|NCT02850913|"~     Nodding syndrome (NS) is a devastating neurologic disorder affecting thousands of children in~     Africa. A number of toxic, nutritional, infectious, para-infectious and environmental causes~     have been studied but the only consistent association has been with infection by the parasite~     Onchocerca volvulus. There is no specific treatment for NS and also for the adult onchocerca.~     However, antibiotic depletion of the Onchocerca volvulus co-symbiotic bacteria Wolbachia with~     tetracyclines such as doxycycline results in sterilisation and premature death of the adult~     worm and marked reductions in dermal microfilaria density. Potentially, such therapy that~     kills adult onchocerca volvulus may improve the outcome of NS if the association were true.~   "
54707|NCT02850900|"~     Response to psoriasis treatment is variable in large part because of poor adherence~     treatments. Studies using electronic monitors have assessed adherence to topical and~     injectable psoriasis treatments and to biologics, yielding critically important insights.~     Adherence to oral psoriasis treatments is not as well characterized but is also critical, as~     the therapeutic windows for these treatments are narrower than for other psoriasis treatment~     options.~      The proposed study will assess patients' adherence to oral psoriasis treatment (primarily~     methotrexate) and will also collect pilot data on an intervention to improve adherence. The~     primary hypothesis of the investigators study is that adherence to oral psoriasis treatment~     is poor and that a reporting intervention may improve adherence to oral psoriasis treatment.~     In the investigator-blinded, 6-month prospective study, patients will be randomized to~     standard-of-care treatment or standard-of-care supplemented with the weekly online reporting~     intervention. Adherence will be assessed using electronic monitors. This randomized trial~     will permit the investigators to determine adherence to oral psoriasis treatment, assess the~     relationship between adherence and psoriasis outcomes, identify factors that are associated~     with adherence to oral psoriasis treatment (including physician trust, confidence in the~     treatment plan, and depression), and obtain preliminary data on the impact of an~     Internet-reporting measure on patients' adherence to oral psoriasis treatment~   "
54708|NCT02850887|"~     The aim of this study is to determine the effect of airway management (a set of medical~     procedures performed to prevent airway blockage and thus ensure an open path between a~     patient's lungs and the atmosphere) during endoscopic retrograde cholangiopancreatography~     [(ERCP), a procedure commonly used to treat conditions of the bile ducts and pancreas] and~     the effect on airway complications (problems), time to biliary cannulation (access into bile~     duct) and total procedure duration (length of time). Two methods are being compared and~     studied: 1) general endotracheal anesthesia: an inhalation anesthetic (substance that blocks~     pain) technique in which anesthetic and respiratory gases pass through a tube placed in the~     trachea (throat) via the mouth or nose vs 2) deep sedation without endotracheal intubation:~     local anesthesia together with sedation (drug that produces sleep) and analgesia (drug that~     treats pain) only.~   "
54709|NCT02850874|"~     This single-center, prospective proof-of-concept study is designed to evaluate the surgical~     outcomes and clinicopathologic results of neoadjuvant hyperthermic intraperitoneal~     chemotherapy (HIPEC) in conjunction with perioperative systemic chemotherapy (SCT;~     neoadjuvant and adjuvant) and pancreaticoduodenectomy (PD) in a small cohort of patients~     having T1-T3 resectable pancreatic ductal adenocarcinoma (PDAC) with one or more high-risk~     clinical features. The investigators hypothesize that HIPEC administered in this clinical~     course will reduce postoperative peritoneal disease recurrence. The investigators also expect~     that local recurrence of disease will be reduced. The primary aim of this study is to compare~     2-year peritoneal disease-free survival between patients receiving the experimental therapy~     (neoadjuvant HIPEC + SCT + PD) with historical controls receiving standard therapy (SCT +~     PD). Secondary aims are to determine the clinical feasibility and outcomes of neoadjuvant~     HIPEC for resectable PDAC using patient demographics and disease characteristic data.~   "
54710|NCT02850861|"~     In condylar fracture surgery, reduction is the most difficult step and the key factor which~     determined the postoperative outcome. Therefore, the aim of this study is to develop a new~     instrument, which the investigators call condylar redactor, to assist the surgeon to reduct~     the condylar segments effectively.~   "
54711|NCT02850848|"~     A Randomized, Parallel, Single-Dose Study to Evaluate the Pharmacokinetics of a Test~     Formulation of Entigin Film Coated Tablet 0.5mg (Entecavir 0.5 mg), Compared to an Equivalent~     Dose of a Reference Drug Product (Baraclude 0.5mg Tablets) in Healthy~   "
54712|NCT02850835|"~     Pelvic organ prolapse (POP) is a highly prevalent condition among women that impairs quality~     of life, daily activities and sexual function. Latina women are disproportionally affected,~     with significantly higher rates of POP compared to women of other ethnicities. Decision aids~     have been used to increase patient knowledge prior to physician intervention and to~     facilitate informed patient participation on treatment selection. The investigators~     hypothesize that the use of a video decision aid prior to initial Urogynecology specialist~     evaluation of Latina women with POP in a border region university-affiliated medical clinic,~     will increase patient knowledge regarding the condition, decrease decisional conflict~     regarding selection among different treatment options and increase patient satisfaction with~     selected treatment.~   "
54713|NCT02850822|"~     Allogeneic hematopoietic stem cell transplantation (allo-HSCT) appears to be an efficient~     tool to cure refractory anemia with excess blasts-1 (RAEB-1), refractory anemia with excess~     blasts-2 (RAEB-2) and acute myeloid leukemia (AML) secondary to myelodysplastic syndrome~     (MDS). At present, the necessity of chemotherapy pre-transplantation for RAEB-1, RAEB-2 and~     AML secondary to MDS (bone marrow blast cells less than 50%) undergoing allo-HSCT remains in~     discussion. In this study, the effects of chemotherapy and no chemotherapy~     pre-transplantation in patients with RAEB-1, REAB-2 and AML secondary to MDS (bone marrow~     blast cells less than 50%) undergoing allo-HSCT are evaluated.~   "
54714|NCT02850809|"~     Multi-institutional registry on a cohort of 310 patients with biopsy-proven renal cell~     carcinoma treated by Radiofrequency ablation. All patients will be included consecutively and~     retrospectively in all centers to obtain the required number of patient followed during 5~     years.~   "
54738|NCT02850497|"~     Aim of this study is to compare at 6 months follow-up, endothelization and malapposition,~     evaluated by means of optical coherence tomography, in terms of number of struts not~     endothelized or malapposed, after the implantation of three new generation stent: Cre8,~     Biomatrix and Xience.~   "
54715|NCT02850796|"~     This study aims to test the efficacy and feasibility of an acceptance, mindfulness and~     compassionate-based intervention for women with overweight and obesity without binge-eating~     disorder (Kg-Free). Kg-Free intervention comprises 10 weekly group sessions plus 2 booster~     fortnightly sessions (31/2months) 2h30 hours each, run in small groups at Coimbra's~     University Hospital. The main goal of Kg-Free intervention is to reduce weight self-stigma~     and unhealthy eating behaviours and promote quality-of-life by targeting weight-related~     experiential avoidance and self-criticism patterns. The intervention focuses on fostering a~     greater awareness and ability to be in contact, tolerate and accept all internal experiences~     (even the unwanted ones, such as craving for food, fatigue, stigma and shame), rather than~     trying to avoid, control or change them. Additionally, the intervention intents for~     participant's to develop a compassionate attitude towards themselves, especially during~     challenging times in order to decrease shame and self-criticism.~   "
54716|NCT02850783|"~     Rationale: Lymph node status is the most important factor in the selection of patients for~     adjuvant chemotherapy after surgical treatment of primary colorectal carcinoma. Up to 30%~     stage I/II patients with negative lymph node involvement will develop distant metastases and~     eventually die from colorectal carcinoma (CRC). Better detection and pathologic staging of~     the lymph nodes could contribute to a better survival of colon cancer patients. This sentinel~     lymph node (SLN) procedure aims to identify the first draining lymph node(s) from the primary~     tumour, which have the highest risk of harbouring metastases. These SLNs can be pathological~     analysed with several more sensitive histopathologic techniques like immunohistochemical~     staining (IHC).~      Objective: Aim of this study is to investigate if the combination of a radioactive and~     fluorescent tracer can increase the sensitivity and specificity of the sentinel lymph node~     mapping (SLNM) technique in colon cancer by utilizing the radioactive component for~     preoperative imaging (PET/CT) of the SLNs and the near infrared (NIR) fluorescence component~     for guidance to the SLNs during surgery.~      Study design: Single centre pilot study Study population: Ten patients with colon cancer~     (colon ascendens, colon transversum, colon descendens, sigmoid) stage Tis-T1-T2-T3, scheduled~     for laparoscopic surgical resection of the tumour.~      Intervention (if applicable):~      The present study will be performed with the radioactive tracer 89Zr-Nanocoll and fluorescent~     tracer Indocyanine Green (ICG). A colonoscopy will be performed to inject the radioactive~     tracer 48 hrs before surgery. After injection, patients will undergo the first PET/CT scan. A~     second PET/CT scan will be performed ± 24 hrs after tracer injection and a third scan just~     before the surgical procedure; ± 48 hrs after tracer administration. During the surgical~     procedure ICG diluted in saline and human albumin will be injected at the base of the tumour~     by colonoscopy. The PET/CT images will be compared with respect to the total number and~     location of foci and , if visible, lymphatic vessels. During surgery the fluorescent nodes~     will be marked with a suture in vivo. Thereafter the PET/CT images will be used as a roadmap,~     to detect SLNs which are not visible with the NIR laparoscope. These nodes will be marked~     with a suture too. When all radioactive and/ or fluorescent nodes are detected, the specimen~     will be resected like the conventional method. Ex vivo the specimen will be inspected for~     fluorescent and/or radioactive nodes not found in vivo. All the identified nodes will be~     taken out ex vivo and stored separately. The entire specimen will be submitted for pathologic~     examination. All identified SLNs will be stained with hematoxylin-eosin (H&E). If the~     fluorescent or radioactive SLNs are negative after routine H&E staining, they will be sliced~     in multiple parts and examined with H&E staining and immunohistochemistry with the specific~     marker CAM5.2. Finally, the pathologist uses palpation to identify the remaining~     non-fluorescent and/ or radioactive lymph nodes. Nodes found by palpation will be screened~     for fluorescent and/ or radioactive activity too.~      The amount of tumour tissue in positive nodes will be evaluated with the Q-prodit; an~     interactive video morphometry system (Leica, Cambridge, UK).~      Main study parameters/endpoints: Main study parameter is the identification rate of SLN~     mapping with preoperative PET/CT scans combined with intraoperative near-infrared (NIR)~     fluorescence imaging in patients with colon carcinoma. Thereby biodistribution and kinetics~     of 89Zr-Nanocoll have to be considered as primary study parameter. Secondary endpoints are~     the number and localization of the SLNs and optimal tracer volume.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: All participating patients will receive conventional resection of the tumour and~     follow-up according to normal standards in our hospital. The main goal of this study is to~     optimize the SLN mapping technique in colon cancer. If the investigators are able to identify~     the true SLN this could lead to better staging and survival of patients with this type of~     cancer. . Because of the colonoscopy ± 48 hrs before surgery, patients stay in the hospital~     will be prolonged with one day. The additional risks of exposure to radiation for~     participating patients are calculated and can be considered as negligible.~   "
54717|NCT02850770|"~     The objective of this study was to investigate the feasibility, perceived usefulness, and~     potential effectiveness of a short text or voice message intervention to activate 1) physical~     activity behavior change among low-income, urban, Latino patients in diabetes management and~     2) supportive behaviors by family members or close friends.~   "
54718|NCT02850757|"~     This study will compare the efficacy of modified William's airway versus U shaped Guedl's~     airway in assistant of fiberoptic bronchoscope during endotracheal intubation~   "
54719|NCT02850744|"~     PQR309 is an oral, dual pan-PI3K (phosphatidylinositol 3-kinase phosphoinositide 3-kinase)~     and mTOR (mammilian target of rapamycin) inhibitor that penetrates the blood-brain barrier at~     pharmacodynamically active concentrations. This study plans to evaluate PQR309 in treatment~     of patients with first progression of glioblastoma.~   "
54720|NCT02850731|"~     Highly diversified programs of physical activity in older people have shown their~     effectiveness in terms of improving functional capacities. Only one of these programs, to~     date, has used a motorized platform. The motorized platform allows the use of sensorimotor~     programs adapted to this population. Thus, for the user, a combination of motor and sensory~     capacities necessary to actively control different positions as well as reactions to maintain~     balance are stimulated, and are as important as psychomotor capabilities to maintain autonomy~     and the fight against losing independence.~      Demonstration of the effectiveness of this type of equipment would propose a new modality of~     physical activity adapted to this population. Use of this new equipment could allow the~     possibility of standardizing this activity, whilst continuing to individualize physical~     activity programs.~      Two phases for each group (Intervention/Control):~      Phase 1 (day 0 - week 6): 2x1 hour sessions per week using the Hu360® (Intervention group) or~     an adapted physical activity program (Control group) under supervision of a therapist who~     will adapt the program according to the progress of the patient, following a standardized~     procedure (exercises: postural/balance training, strength training for the legs/trunk and~     coordination and endurance activities) Phase 2 (week 6 - month 6): Physical activity program~     at home for both groups, performed independently.~      Blinded evaluations will be performed at 6 weeks and at 6 months for each group.~      The investigators hypothesis is that the use of the motorized platform will allow superior~     physical performance compared to a traditional physical activity program.~   "
54721|NCT02850718|"~     A comparative bioequivalence study in 48 healthy male volunteers of oral Viagra and a test~     sublingual sildenafil wafer.~   "
54722|NCT02850705|"~     Devic's neuromyelitis optica (NMO) is rare. Epidemiological and demographic data are poor,~     based mainly on monocentric cohorts. Moreover, NMO might be difficult to distinguish from~     multiple sclerosis and begin with atypical or incomplete clinical presentations. Therefore,~     NMO is still underdiagnosed. The constitution of a nationwide and prospective cohort,~     including not only NMO but also clinical syndromes suggestive of a first episode~     (DNMO-spectrum disorders (SDs)), should allow to gather a critical mass of cases and answer~     questions that could not have been addressed at the level of a single centre.~      Objectives: The main objective is to describe the clinical, radiological and biological~     features of NMO spectrum disorder (NMO, isolated longitudinally extensive transverse myelitis~     (LETM), relapsing or not; isolated atypical optic neuritis (ON)) and their evolution. The~     second aim is to create a biobank dedicated to NMO (serum, whole blood for RNA and DNA~     extraction, cerebrospinal fluid), to promote translational research in the field. Methods:~     NOMADMUS is a prospective, multicentre, observational study of patients NMOSD and related~     disorder in France. Prevalent cases are included retrospectively and then followed~     prospectively. Incident cases are included from disease onset and followed prospectively. A~     minimal set of data has been defined and synthesized on specific paper forms derived from the~     European database for multiple sclerosis (EDMUS) forms. Patients are systematically tested~     regarding their AQP4-IgG and MOG-IgG status. All the data are centralised in a EDMUS-derived~     database in Lyon, the EDEN software. All cases are validated and classified by an expert~     committee.~   "
54723|NCT02850692|"~     Cystic fibrosis can affect organs other than the lungs. Liver disease affects about 30% of~     patients: its main manifestation is the development of portal hypertension (PHT). The~     pathophysiology of this comorbidity is still poorly understood. It was previously considered~     secondary to the formation of biliary cirrhosis but another hypothesis would be that of a~     primitive pathology of venous vessels may cause the gradual emergence of portal hypertension~     without cirrhosis. Evidence indiscutly suggest that cystic fibrosis is associated with a~     specific endothelial dysfunction, especially as the CFTR (Cystic Fibrosis Transmembrane~     conductance Regulator) protein is expressed on the surface of endothelial cells. The~     investigators hypothesize that liver disease related to PHT−associated cystic fibrosis is~     associated with systemic endothelial dysfunction.~      The aim is:~      To demonstrate a systemic endothelial dysfunction in patients with cystic fibrosis when~     associated with PHT.~      To study the correlations between measures of systemic endothelial function and serum markers~     of endothelial dysfunction and between measures of liver stiffness and systemic endothelial~     function.~   "
54724|NCT02850679|"~     This is a retrospective multi-center patient cohort study investigating patients with~     persistent atrial fibrillation (AF) and elective cardioversion (ECV). The aim is to identify~     clinical predictors for ineffective ECV to improve management quality of persistent AF.~   "
82109|NCT02492204|"~     The main objective is the study of the role of IL33/ST2 axis in the pathogenesis of ARDS,~     it´s value as prognosis marker and as therapeutic target.~   "
54725|NCT02850666|"~     This is a one-group, pre-post feasibility study of an intensive, interdisciplinary (theatre,~     Occupational Therapy (OT), and Speech Language Pathology (SLP)) intervention targeted at~     social skill development in children, aged 3-4. The intervention uses process drama modified~     with OT and SLP techniques and using typically developing peer models. Feasibility outcomes~     are recruitment rates, retention rates, daily program records of ease of implementing~     program, and record of modifications needed. Child primary outcomes are Social Skills~     Improvement Scale (SSIS), Theory of Mind (T0M) Battery and Inventory, Structured Play~     Assessment (SPA), and Communication and Symbolic Behavior Scales (CSBS) scores within 4 weeks~     of program end. Secondary outcomes are brain activity in frontal lobe and temporal/parietal~     areas measured by high density EEG within 4 weeks of program end, parental interview at 3~     months related to child's social skills, and observational data on social skills during the~     program.~   "
54726|NCT02850653|"~     Endophthalmitis is a serious eye infection of exogenous origin (post-operational,~     post-traumatic) or endogenous origin (metastatic). This is a diagnostic and therapeutic~     emergency.~      Each patient suffering from endophthalmitis must have immediately an ocular sampling, an~     intra ocular injection of antibiotics and a systemic antibiotic cover.~      The etiological treatment will be adapted according to the infectious agent.~   "
54727|NCT02850640|"~     Cost and Medical Care of Patients with Advanced Serious Illness in Singapore (COMPASS),is a~     cohort study which aims to capture health care utilization, cost, and quality of life~     indicators of patients with advanced cancer and their primary caregivers.~   "
54728|NCT02850627|"~     The purpose of this study is to test the expression of microRNAs related to the syndromes~     after the intervention of Tongguan capsule,preliminarily to investigate the mechanism of the~     effects of Tongguan capsule, and provide the biological foundation of curative effect of~     Tongguan capsule.~   "
54729|NCT02850614|"~     Juniors and seniors will be recruited to participate in the study, which will begin in the~     fall 2016 and run through May. The intervention will be a randomized-controlled trial, where~     students are randomized to either a control or incentive condition. Physical activity will be~     automatically tracked throughout the study period using FitBit activity trackers wirelessly~     linked to the gaming application on students' Chromebooks or mobile phones. Students who~     achieve 30 minutes of MVPA during the school day and/or 60 minutes of MVPA over the entire~     day will receive in-game rewards moving them up leaderboards in the game, providing them with~     more game points, or allowing them access to more game elements. Baseline outcome measures~     will be collected at the beginning of the school year in the fall, and post-intervention~     outcome measures will be collected in May.~   "
54730|NCT02850601|"~     The objective of this single center, 4-week, open label randomized, phase II study is to~     evaluate and characterize the tolerability and clinical effectiveness of dexamethasone~     0.5mg/5ml solution in a mucoadhesive vehicle (Mucolox™) for the treatment of oral lichen~     planus.~   "
54731|NCT02850588|"~     The VQI TCAR Surveillance Project is designed to monitor the safety and effectiveness of~     stents placed directly into the carotid artery while reversing blood flow within the carotid~     artery to reduce stroke risk. It will compare this less-invasive surgical procedure with~     standard carotid endarterectomy in centers that participate in the Society for Vascular~     Surgery Vascular Quality Initiative.~   "
54732|NCT02850575|"~     This study aims to evaluate long term fixation of the Mpact Double Mobility cup trough~     IMAGIKA technology.~   "
54733|NCT02850562|"~     The objective of this study is to test the effects of a healthy diet & walking (Controls)~     compared to a healthy diet, walking, and balance/strength exercises (Intervention) on muscle~     density in two populations: elderly individuals and obese individuals. The intervention will~     be 3 months in length. During this time, both Control and Intervention groups will meet one~     time each week for educational sessions on healthy diet strategies and to participate in a~     group walk for the Control group or group exercises for the Intervention group. The Control~     group will be asked to walk on their own an additional 4 times per week (5 times total) for~     at least 10 minutes/day at the start of the study and build to 30 minutes/day by the 3-month~     time point. The Intervention group will walk two times per week using the same criteria as~     above, and in addition will do balance/strength exercises on a total of three days per week.~     Measurements will be made at baseline, at intervention completion (3 months) and at a~     follow-up (6 months -3 months after completion of the intervention). At 3 months, the control~     group will be invited to add the balance/strength exercises.~      The hypotheses are that adding balance & strength exercises to a healthy diet plan will~     increase muscle density (decrease fat infiltration) and improve muscle function in the~     elderly and in the obese populations. Increases in muscle density are expected to show~     greater improvements in muscle function in the elderly population, while it is speculated~     that greater improvements in metabolic measures will show in the obese population.~     Participants in the intervention group will have a greater reduction in falls and less~     hospital, ER & clinic visits compared to the control group, but both groups will have an~     improved quality of life, positive changes in eating behaviors, and decreased perceived~     stress.~   "
54734|NCT02850549|"~     The purpose of this study was to assess if pain and function in patients with neck pain is~     less when physical therapists use a classification system.~   "
54735|NCT02850536|"~     This is an open label, fixed dose, phase Ib trial of anti-CEA CAR-T cell infusions delivered~     via the hepatic artery or splenic vein using the Surefire Infusion System (SIS) for patients~     with CEA-expressing liver metastases or pancreas cancer.~   "
54736|NCT02850523|"~     Anxiety Disorders (AD) are a serious mental health concern, affecting up to 15% of perinatal~     women. AD often coexists with depression and result in high distress and an impaired ability~     for new mothers to take care of themselves and their babies. In spite of the high prevalence~     of AD during pregnancy and postpartum, research and clinical attention in this area is~     lacking and no know empirically supported psychological treatments exist. Further, since many~     perinatal women are unable to choose not to take medication for their mental health symptoms,~     establishing an effective non-pharmacological alternative is imperative.~     Cognitive-behavioural therapy (CBT) is a well-established psychological treatment for mental~     health disorders, with noted moderate to large effect sized (.5-1.3). The investigators have~     recently developed a novel CBT treatment program for perinatal women with AD and ran an~     initial pilot study thereafter. A significant reduction in symptoms of anxiety and depression~     was found, along with reported high levels of treatment satisfaction. The purpose of the~     current study is to confirm the effectiveness of this treatment using a larger sample in the~     form of a rigorous randomized controlled trial (RCT).~   "
54737|NCT02850510|"~     Aim of study:~      To evaluate the effects of the shortened version of the Incredible Years (IY) Basic~     programme, the study which the parents were recruited to. A randomising experimental control~     between-group design was used with pre- and post-intervention measurements, and a one-year,~     four-year and ten-year follow-up. Children and families were randomized to either the~     shortened basic version (n = 89), or the control group (n = 97).~   "
54740|NCT02850471|"~     TEAS might protect against postoperative pulmonary such as ischemia-reperfusion injury (IRI)~     and atelectasis. We tested the hypothesis that transcutaneous electrical acupoint stimulation~     protects against postoperative pulmonary complications in patients who are receiving~     mechanical ventilation during general anesthesia for gynecologic laparoscopic surgery.~   "
54741|NCT02850458|"~     The purpose of this study is to evaluate the clinical results of implant-retained mandibular~     overdentures in edentulous patients.~   "
54742|NCT02850445|"~     Regular psychosocial intervention combined with antipsychotic drugs, compared with usual~     medication alone treatments, can reduce psychiatric symptoms and improve quality of life in~     patients with schizophrenia. However, it's expensive, time-consuming, and sometimes~     inconvenient for patients and their family members in developing areas where the number of~     well-trained therapist remains limited in local psychiatric settings. The investigators aimed~     to establish an efficient model of integrated treatment (IT) for patients with schizophrenia.~     The procedure contains two stages: a centralized treatment during hospitalization and the~     following consolidation treatments with long intervals.~   "
54743|NCT02850432|"~     The aim of this study is to establish a clinically feasible simultaneous evaluation of heart~     and lower limb using MRI and to assess the combined benefit of clinical and cardiac MRI~     imaging markers in the evaluation of PAD and prediction of treatment outcome.~   "
54744|NCT02850419|"~     The 105-15-201 study is designed to assess the effectiveness and tolerability of the~     combination of heat-activated target therapy (radiotherapy + hyperthermia +~     lyso-thermosensitive liposomal doxorubicin) of loco-regional relapse in breast cancer~     patients.~   "
54745|NCT02850406|"~     This study consists of two parts, Part A and Part B. Part A is a single dose PK study in~     pediatric participants with Sickle Cell Disease. Part B is a multiple dose safety,~     exploratory efficacy and PK study in adolescent Sickle Cell Disease participants.~   "
54746|NCT02850393|"~     Mental-health conditions affect million people worldwide. The economic burden of mental~     illness is enormous and the economic health of both developing and developed nations will~     depend on controlling the staggering growth in costs from mental disorders.~     Obsessive-compulsive disorder (OCD) is a relatively common and frequent form of anxiety that~     affects approximately 2-3% of the population. OCD is characterized by anxiety, obsessions~     (persistent intrusive thoughts and images with highly distressing contents) and compulsions~     (repetitive activity), and severely impairs the lives of those affected. Despite their~     interest as effective and affordable care and rehabilitation, cognitive therapeutic profits~     too little from the increasing accumulation of knowledge in neuroscience, and neuroscientists~     pay too little attention to the challenges faced by clinical psychologists and psychiatrists.~     To reduce this cultural gap, two teams specialized in the study and multimodal imaging of~     healthy participants and clinical patients with mental health disorders, the UMR-S~     INSERM-EPHE-UNICAEN U1077 unit led by Francis Eustache, and ISTS team (UMR-S 6301~     CNRS-CEA-UCBN) led by Sonia Dollfus, will joint their efforts to develop an integrated~     approach of the neural mechanisms at stake from basic neuroscience using state-of-art~     neuroimaging techniques, to novel and ground breaking psychological intervention. Both teams~     evolve at the brain imaging Cyceron center in Caen in connection with the Mental Health and~     Addictology Center, offering unique opportunities for such translational research. This~     project will capitalize on recent evidence showing that healthy participants can prevent~     unwanted images from entering consciousness using inhibitory control and memory suppression~     techniques, disrupting traces of the memories in sensory areas of the brain, and weakening~     their vividness and later reentrance. OCD is characterized by aberrant and excessive visual~     intrusions, usually extremely vivid, detailed, and unpleasant. These distressing images are~     particularly uncontrollable and may frequently initiate compulsive rituals. In a first phase~     of this proposal will use functional magnetic resonance imaging (fMRI) to develop a~     neurobiological model of the cognitive computations achieved by inhibition network to~     suppress memory. To achieve this goal we will develop an attentional model of healthy memory~     inhibition functioning, simulating the deployment of attentional resources and the different~     mental processes at stake during suppression. Using sophisticated analyzing tools of fMRI~     data, we will use this model to decode and infer the representational content of the brain~     inhibition network, and further refine the connectivity pathways which underlie such control.~     The lack of a strong neurobiological model prevents the development of therapies which would~     increase functionality of this network and optimize intervention aiming to disrupt mental~     intrusions and obsessions. In a second phase, we will assess whether memory suppression may~     be transferred and trained in OCD patients using images depicting their own obsessions, as a~     promising avenue to reduce their symptoms on the long run. In addition, fMRI and other brain~     structural acquisitions will be collected before and after cognitive training to memory~     suppression, offering a unique opportunity to observe the online dysfunction of intrusion~     control in OCD patients and to identify neurobiological markers predictive of training~     outcome and network reconfiguration with training. A fundamental goal of motivated forgetting~     involves not only to exclude unwelcome content from consciousness but also to reduce their~     later emotional impact by doing so. In parallel of these two main phases, we will thus also~     measure physiological markers of autonomic nervous system activity changes in response to~     suppressed images to better identify the consequences of memory suppression on emotional~     states, anxiety, and mental health in general.~   "
54747|NCT02850380|"~     The purpose of the study is to investigate spatial orientation in weightlessness as it~     manifests not in perception but rather in motor performance by direction and reaction time of~     flip switch.~      Hypotheses are that flip switch:~        1. will be biased towards visual allocentric cues when those are available;~        2. will be biased towards the egocentric reference when tactile cues are added;~        3. will be dominated by egocentric cues when visual cues are not available;~        4. will be delayed and more variable when confirmatory gravitational cues are absent;~        5. will be faster and more reliable in absence of conflicting gravitational cues, and even~          more so when tactile cues are added;~        6. The difference will be more pronounce when tested under Dual-task condition~   "
54748|NCT02850367|"~     NO is an ubiquitous molecule contributing to many physiological functions such as~     vasodilation, immune and oxidative stress responses. NO production can be supplemented either~     by providing substrate to the NO-synthase (L-Arginine and L-Citruline) or by providing~     nitrate which can lead to NO. In the present project the investigators evaluate the effect of~     various acute and chronic oral NO precursors supplementation on exercise performance and~     responses in healthy young and older subjects.~   "
54749|NCT02850354|"~     The regulation of the cardiovascular respiratory system after changing environmental~     conditions or changes in work rates are essential for cognitive as well as physical~     functioning. For decades, it is known that high level of headward acceleration (+Gz) impairs~     cardiovascular function that may cause loss of consciousness. Some anti-g maneuvers, such~     as muscle contraction of the lower extremities and buttocks or intermittent exhalation on~     exertion (i.e., exhalation against a closed airway) have been proved to increase tolerance to~     high +Gz.~      Main objective of this experiment is to investigate the effects of anti-g maneuvers on~     cardiovascular and respiratory tolerance to the push-pull-effect.~      Cardiovascular and respiratory functions will be evaluated with the following parameters:~     heart rate, stroke volume, cardiac output, blood pressure, oxygen uptake, carbon dioxide~     output, ventilation, breathing frequency, body core temperature.~      Electromyography (EMG) will not be a judgment criteria but will be used to check the quality~     of 'muscle contraction' anti-g maneuver.~      The main hypothesis is that anti-g maneuvers will increase cardiovascular and respiratory~     tolerance to the push-pull effect, especially when they are combined.~   "
54750|NCT02850341|"~     The purpose of this study is to determine if the use of pedometers can help depressive~     inpatients in psychiatric clinics to increase their level of physical activity. Therefore~     patients are given a pedometer and instructions how to raise their level of daily steps.~     Intervention group is compared with a control group that is receiving treatment-as-usual. The~     intervention is hypothesized to increase number of daily steps and have positive effects on~     mood, depression and anxiety.~   "
54751|NCT02850328|"~     The aim of this study is to evaluate the applicability of high-load resistance training as a~     countermeasure for long term space flights, the current project has two scientific goals.~      The main objective is to perform a deeper examination of muscle function and MVC in~     weightlessness (parabolic flight).~      The secondary objective is to gather further insight into the underlying mechanisms and~     structures based on investigations targeting the neuromuscular and musculotendinous systems~     and their interaction.~   "
54752|NCT02850315|"~     The pharmacoinvasive approach after thrombolysis is the standard treatment of myocardial~     infarction when deadlines are too long for primary angioplasty. Coronary angioplasty is then~     carried out within 3 to 24 hours following thrombolysis. The adjuvant antiplatelet therapy of~     thrombolysis combines aspirin with clopidogrel (75 or 300 mg depending on age). These~     clopidogrel doses are associated with a very low anti-platelet aggregation response within 24~     hours following administration. However, the antiplatelet agregation that inhibits the~     progression of intracoronary thrombus must be optimal at the time of angioplasty to reduce~     the risk of thrombotic events. Intracoronary thrombus residual angiographic post-thrombolysis~     was associated with impaired myocardial reperfusion but coronary angiography has a very low~     sensitivity for detecting the thrombus. The optical coherence tomography (OCT) is currently~     the method of choice to visualize and quantify the intracoronary thrombus. It is used~     routinely in the presence of a thrombus to correctly estimate the size of the artery and for~     the evaluation of good stent apposition.~      The thrombectomy at the time of angioplasty improves myocardial reperfusion, particularly in~     case of major thrombotic mass. Intracoronary thrombus residual post-thrombolysis could be a~     marker for the quality of reperfusion itself correlated to the quality of the antiplatelet~     post-thrombolysis.~      The investigators therefore hypothesize that the systematic use of the OCT before elective~     angioplasty (within 3 to 24 hours) after successful thrombolysis could be used to guide the~     use of thrombectomy and adequate stenting and thus improve myocardial reperfusion. Our study~     will also correlate the importance of the residual thrombus before angioplasty myocardial~     reperfusion one hand and to the inhibition of platelet activity observed other.~   "
56954|NCT02821520|"~     To compare the initial versus delayed verteporfin photodynamic therapy (PDT) in combination~     with conbercept in patients with symptomatic polypoidal choroidal vasculopathy (PCV).~   "
54753|NCT02850302|"~     Breast cancer is a major public health problem. In France, it is the leading cause of cancer~     death in women. According to the National Cancer Institute (INCA), approximately 49,000 new~     cases were diagnosed in 2012 in France.~      It is an heterogeneous disease, comprising a plurality of entities whose clinical behavior,~     biological and prognosis differ. Amongst these entities, the breast cancer triple negative~     (TN) is defined by the absence of expression of estrogen receptor and progesterone and the~     absence of overexpression of HER2 oncoprotein. It represents about 15% of breast cancers and~     occurs more frequently in young women. This is a very proliferative tumor phenotype with~     metastatic potential. Because of its genomic heterogeneity and lack of recurrent identified~     molecular target, no targeted therapy has today shown benefit in terms of survival compared~     to conventional cytotoxic chemotherapy, which partly explains the very poor prognosis of this~     tumor phenotype. The positron emission tomography (PET) with 18Fluoro-deoxy-glucose (FDG) is~     a molecular imaging test that can identify from the first or second neoadjuvant chemotherapy~     treatment non-responder patients to treatment with low probability of pathologic complete~     response (pCR) after neoadjuvant chemotherapy. For this two FDG-PET examinations should be~     performed; a) a pretreatment PET b) a control PET after one or two treatments. The objective~     of this pilot, single-center, prospective study is a preliminary identification of recurrent~     genomic alterations among triple-negative tumors with early chemoresistance, identified by~     PET in the first cycle of neoadjuvant therapy.~   "
54754|NCT02850289|"~     This multi-center, observational study will examine the clinical use and outcomes of~     pegylated interferon (PEG-IFN) alfa-2a and ribavirin combination (PEGASYS RBV) in~     participants with chronic hepatitis C (CHC). Study visits will be scheduled for baseline, 12,~     24 and 48 weeks after baseline. An additional follow-up visit at week 72 will be required for~     participants with an HCV genotype other than 2 or 3. Quality of life data will be collected~     at baseline, and at each follow-up visit.~   "
54755|NCT02850276|"~     The purpose of this study is to explore a possible link between the autonomic nervous system~     and immune function in patients with HIV. Sometimes HIV can cause these nerves to function~     abnormally, this is called HIV-associated autonomic neuropathy (HIV-AN). HIV-AN is a~     condition that is different from person to person. In some people it causes no symptoms and~     is not harmful, in others it may cause symptoms such as dizziness or lightheadedness, nausea,~     vomiting, diarrhea, constipation, or problems urinating. Most people with HIV-AN don't know~     that they have it. One of the important nerves in the autonomic nervous system is the vagus~     nerve. Abnormal function of the vagus nerve may cause stomach and intestinal slowing, which~     could lead to an overgrowth of bacteria. The body senses these bacteria and tries to fight~     them, leading to inflammation.~      In this study the researchers will test whether abnormal function of the vagus nerve in HIV~     is associated with stomach slowing and overgrowth of bacteria, and if a drug called~     pyridostigmine can help.~   "
54756|NCT02850263|"~     Intravitreal aflibercept has been approved for the treatment of visual impairments due to~     diabetic macular oedema (DMO) in Europe and the US in August 2014 and July 2014 respectively.~      The main objectives of this observational cohort field study are to evaluate effectiveness of~     intravitreal aflibercept and to describe follow-up as well as treatment patterns in anti~     vascular endothelial growth factor (anti-VEGF) treatment naïve patients with DMO in routine~     clinical practice in the United Kingdom.~   "
54757|NCT02850250|"~     -  To evaluate plasma concentrations of Cefuroxime in this patient population~        -  To determine if certain pathophysiological and/or iatrogenic conditions alter the~          pharmacokinetics in this patient group.~        -  To develop a rational physiological population pharmacokinetic model that describes~          plasma concentrations of medications in these patients.~   "
54758|NCT02850237|"~     Cerebral saturation will be measured pre-hospital during an out-of hospital cardiac arrest~     with O3TM regional oximetry for Root® (Masimo®). The O3TM regional oximetry for Root®~     (Masimo®) is a device that can measure not only cerebral saturation but also end-tidal CO2~     (capnography). Currently, end-tidal CO2 is already measured during Advanced Life Support~     following most recent European Resuscitation Guidelines but with another monitor. Until now~     it is the only parameter which may predict return of spontaneous circulation. Because of~     this, researchers want to measure both with the same device, which gives the investigators~     the opportunity and advantage to compare end-tidal CO2 and cerebral saturation very~     precisely. In this manner researchers want to investigate the predictive value of cerebral~     saturation and compare it end-tidal CO2.~   "
54759|NCT02850224|"~     In 2012, an Expert Panel of the National Heart Lung and Blood Institute published guidelines~     on cardiovascular health and risk reduction in children; among these guidelines were~     screening recommendations for obesity and obesity-related conditions. Following publication~     of this report there was a call for caution and for increased patient (parent, child) input~     on implementing these guidelines. There are limited current studies evaluating~     patient-centered outcomes (PCO) in the well-child setting, however, given the childhood~     obesity epidemic, there is a clear need for such an evaluation. The city of Detroit, MI ranks~     first among 22 cities with data for the prevalence of overweight and obese youth (39.7%),~     making Henry Ford Health System, which is located in Detroit, MI, an ideal setting to study~     childhood obesity related research questions.~   "
54760|NCT02850211|"~     Selective cyclooxygenase (COX)-2 inhibitors are commonly used analgesics that provide similar~     analgesia but reduced adverse effects compared to other analgesics. However, few studies have~     been conducted on postoperative pain and tendon-to-bone healing. Here, the investigators~     investigated the effect of a selective COX-2 inhibitor on analgesia and tendon-to-bone~     healing following arthroscopic rotator cuff repair.~   "
54761|NCT02850198|"~     This research is primary to compare effectiveness of scalp electroacupuncture and scalp~     acupuncture on motor function of the upper limb(UL) in convalescence phase of ischemic~     stroke. The clinical research is a randomized controlled trial (RCT),consisting of two arms~     of scalp electroacupuncture group and sham sclp electroacupuncture group to value difference~     of upper limb function after 4 weeks. The result indicates that scalp electroacupuncture is~     more sufficient to alter function. The purpose is to value effectiveness of scalp~     electroacupuncture on motor function of the upper limb in convalescence phase of ischemic~     stroke.~   "
54762|NCT02850185|"~     The purpose for this study is to determine safety and effectiveness of the oxyhydrogen~     generator with nebulizer through an adjuvant therapy for the severe COPD patients in the~     stable phase.~   "
54763|NCT02850172|"~     The purpose of this stratified randomized controlled trial (RCT) is to test the effects of~     Walk, Eat, & Breathe on preserving patients' nutritional status, functional walking capacity,~     pulmonary function, and emotional well-being during the CCRT and surgery course.Additionally,~     effects to reduce treatment-related complications and length of hospital stay for~     esophagectomy will be evaluated between experimental and control groups.~   "
54764|NCT02850159|"~     The purpose of this study is to investigate the effect of dual-mode non-invasive brain~     stimulation (NIBS) with high-frequency repetitive transcranial magnetic stimulation (rTMS)~     over the primary motor cortex of the lower leg and anodal transcranial direct current~     stimulation (tDCS) over the left dorsolateral prefrontal cortex compared with rTMS alone in~     patients with Parkinson's disease (PD) with freezing of gait (FOG).~   "
54765|NCT02850146|"~     Approximately 50 participants enrolled in the LEARN study (NCT02488720) will be enrolled in~     the LEARN-Tau study. The study designed to evaluate the imaging characteristics of~     18F-AV-1451 in participants enrolled in the LEARN study and to expand the safety database of~     18F-AV-1451.~      The study will run in parallel to the LEARN study. In this study, participants will undergo~     up three (3) 18F-AV-1451 PET scans over a 3 year period. Imaging visits will occur at the~     start, middle and end of the participant's participation in the LEARN study (corresponding to~     LEARN Visit 1, between Visit 4 and 6, and Visit 8).~      The LEARN-Tau study will (1) look at change in the amount of tau protein in the brain over~     time, measured by the 18F-AV-1451 PET scan, (2) see if tau protein in the brain of older~     individuals is associated with memory problems and (3) evaluate the safety of 18F-AV-1451 and~     any side effects that might be associated with it.~      Site investigators, participants, and study partners will not be informed of the results of~     the 18F-AV-1451 PET scan results as they relate to the study; however, any findings that may~     be of potential medical concern will be provided for appropriate follow-up.~   "
54766|NCT02850133|"~     Background:~      Patients with spinal cord injury (SCI) have a higher prevalence of cardiovascular diseases~     compared to the healthy population. Aerobic exercise training is one of the recommended~     treatments. However, literature regarding the effect of aerobic training on patients with SCI~     is scarce. This study evaluated changes in parameters of exercise physiology and serum~     myokines immediately after exercise and after a training program among patients with SCI.~      Method:~      Male patients with SCI and age- and sex-matched healthy individuals were recruited.~     Cardio-pulmonary exercise testing (CPET) was used to determine oxygen uptake at peak exercise~     and anaerobic threshold in both groups. The patients with SCI attended aerobic exercise~     training for 36 sessions within 12-16 weeks. Basic data, hemodynamic and exercise physiology~     parameters, and serum myokine (myostatin, insulin like growth factor, and follistatin)~     concentrations were measured pre- and post-exercise in both groups, and were repeated in~     patients with SCI post-training.~   "
54767|NCT02850120|"~     Complications from mesh procedures (i.e. insertion of tension-free vaginal tapes (TVT),~     trans-obturator tapes (TOT) and suprapubic slings (SS)) used during surgical treatment of~     stress urinary incontinence have caused major concern around the world.~      The investigators aim to conduct a retrospective cohort study using administrative inpatient~     data from the Hospital Episode Statistics (HES) database to determine the complications of~     all first-time surgical mesh procedures in the treatment of stress urinary incontinence (SUI)~     in women treated in a National Health Service (NHS) hospital in England who were discharged~     from hospital between 1st April 2007 and 31st March 2015.~      The primary outcome measure is the number and types of complications (occurring~     peri-procedurally, within 30 days of the mesh procedure and those occurring during~     follow-up). Additional outcomes recorded include: the numbers and types of mesh procedures,~     including those with potentially confounding concomitant procedures.~   "
54768|NCT02850107|"~     This study is designed to collect information during a procedure that is routine care for~     treating a blockage in a blood vessel in the upper part of the participant's leg. This study~     is for data collection reasons to help doctors gain better understanding of the treatment of~     disease in the blood vessels of the legs. You will be treated with two devices that are~     routine, or standard of care, for your doctor to treat blockages in the blood vessel of the~     leg. The treatment is for a blockage or narrowing caused by plaque build-up in the blood~     vessel. Data will be collected to assess what length of time the blood vessel will be~     prevented from re-narrowing through twenty-four (24) months after the procedure.~   "
54769|NCT02850094|"~     The investigators propose a 24 week program to provide proof-of-principle evidence that~     financial incentives stimulate Brigham and Women's Hospital (BWH) employees to be more~     physically active.~   "
54770|NCT02850081|"~     The investigators hypothesize that pre-operative statin use is neuroprotective at maximal~     doses. The goals are to determine the safety, feasibility, and efficacy of maximizing statin~     doses for two weeks (12-18 days) prior to CEA using change in performance on a battery~     neuropsychometric tests as outcome measure. Study will recruit patients based on their~     preexisting statin regimen.~      The investigators hypothesize that in asymptomatic CEA patients: 1) Pre-operative statin use~     is neuroprotective against early cognitive dysfunction (eCD) and lowers the risk of early~     mortality. 2) Maximal doses may be essential in achieving optimal neuroprotection against~     eCD.~   "
54771|NCT02850068|"~     This study is to test a new treatment method, geniculate artery embolization (GAE), to reduce~     the severity of pain and disability caused by knee osteoarthritis.~   "
54772|NCT02850055|"~     Tinnitus is one of the most prevalent symptoms that causes more disability in patients with~     temporomandibular disorder (TMD). The present study postulates a possible link between~     temporomandibular joint (TMJ) and inner ear based on their anatomical, biomechanical and~     physiological relationship, proposing a physiotherapy treatment for the temporomandibular~     joint to improve tinnitus.~      The aim of the study is to evaluate the effectiveness of adding specific manual therapy to a~     multimodal physiotherapy treatment in patients with tinnitus and temporomandibular disorder.~   "
54773|NCT02850042|"~     This pilot study was designed to compare the effects of modified constraint-Induced therapy~     and occupation-based intervention to increase functional motor recovery in stroke~   "
54954|NCT02847676|"~     Our study aims to characterise a possible pluripotent cell population in the abdomen~     responsible for peritoneal adhesions. We therefore want to take samples from women undergoing~     planned laparoscopic surgery with and without adhesions, isolate the cells and characterise~     them for markers of pluripotency.~   "
54774|NCT02850029|"~     This is an international observational cohort study on current aminoglycoside practices in~     intensive care units. Clinical and demographic data, dosing and therapeutic drug monitoring~     data will be collected during the first week of aminoglycoside (tobramycin, amikacin or~     gentamicin) administration in different countries over a year. A minimum of ten consecutive~     patients will be enrolled at each site.~   "
54775|NCT02850016|"~     The aim of this protocol is to evaluate the effects of romidepsin plus 3BNC117 or romidepsin~     alone on delaying or preventing viral rebound in ART-treated HIV-1-infected individuals~     during an analytical interruption of ART.~   "
54776|NCT02850003|"~     Study designed to assess the safety and plasma PK of tretinoin and its metabolites from~     topically applied IDP-120 gel.~   "
54777|NCT02849990|"~     This phase II trial studies how well apalutamide, abiraterone acetate, prednisone, degarelix,~     and indomethacin work in treating patients with prostate cancer that has spread from where it~     started to nearby tissue or lymph nodes before surgery. Androgen can cause the growth of~     tumor cells. Hormone therapy using apalutamide, abiraterone acetate, prednisone, degarelix,~     and indomethacin may fight prostate cancer by lowering the amount of androgen the body makes~     and/or blocking the use of androgen by the tumor cells.~   "
54778|NCT02849977|"~     The purpose of this screening study is to identify people who have a rare genetic cause of~     obesity - specifically three genetic variants (a change in the DNA structure) of the POMC,~     PCSK1 and LepR genes that are currently known to result in obesity.~      This screening study will not include any investigational drugs. You will be asked to provide~     a DNA sample and answer some questions about your medical history and hunger.~   "
54779|NCT02849964|"~     The REIN registry highlights significant disparities in the incidence of end-stage renal~     disease (ESRD) between regions, especially in the North East of France. According to the~     literature, the incidence of ESRD in an area could be related to contextual factors~     influencing the needs for dialysis or transplantation (age structure, prevalence of risk~     factors, socioeconomic and morbidity levels), as well as to primary and secondary care~     provision (general practitioners and nephrologists) and to practice patterns in nephrology.~      The aims of this project are the following:~        1. to compare the incidence of renal replacement therapy (dialysis or preemptive~          transplantation) for ESRD between the départements and the cantons belonging to the~          5 regions of Eastern France (Alsace, Lorraine, Champagne-Ardenne, Bourgogne and~          Franche-Comté), while taking into account differences in population sizes and spatial~          patterns of the data,~        2. to analyse the relations between incidence disparities and socioeconomic environment,~          geographic accessibility to primary and secondary care and medical practice patterns,~          after adjusting for morbidity and mortality rates (incidence of diabetes, cardiovascular~          mortality).~      This project will enable a better understanding of the mechanisms involved in the spatial~     variations of ESRD incidence, while disentangling effects related to the need from effects~     related to service supply in different socio-economic contexts. It will be possible to~     identify a lack of equity in access to renal replacement therapy if, after adjusting for need~     indicators, there were variations of incidence of ESRD related to availability of service or~     to socioeconomic context. Highlighting such effects would lead to search for corrective~     measures in collaboration with the different stakeholders.~   "
54780|NCT02849951|"~     The purpose of this study is to determine whether Phosphatidylcholine (LT-02) add on~     treatment is effective and safe for the induction of remission in ulcerative colitis patients~     refractory to standard treatment with mesalamine~   "
54781|NCT02849938|"~     The specific aims of the study are to:~        1. Assess the feasibility of a TytoCare telehealth device with remote audio/video~          connection for evaluation of children with medical complexity in the home environment.~        2. Evaluate the usability of a TytoCare telehealth device in transmitting real time images~          (otoscope, oropharyngeal exam, camera), temperature, and sound (stethoscope for heart~          and breath sounds)~        3. Compare the impact of the TytoCare telehealth device versus traditional telephone~          assessment on patient management and user satisfaction~   "
54782|NCT02849925|"~     This study aimed to test whether sealing microcavitated ICDAS 3 carious lesions in permanent~     molars may be arrested by sealing using two different types of materials; a glass ionomer and~     a resin sealant. A Randomized controlled clinical trial was designed. Children between 6 and~     12 years old were recruited and a total of 150 ICDAS 3 lesions in first permanent molars were~     allocated to one of the two arms of the study. Clinical and radiographic lesion progression~     were the main outcome. Integrity of the material and retention were secondary outcomes. A~     follow up period of 24 months with check-ups at 6 and 12 months was considered.~   "
54783|NCT02849912|"~     Non Hodgkin lymphoma (NHL) is the 5th cancer in France. Advances in NHL therapy have resulted~     in improved cure rates with a 5 year relative survival rate estimated at 55% and a 5-year~     prevalence estimate of 27,750 cases. Since 2000, the addition of anti-CD20 antibody to the~     standard treatment regimen composed of cyclophosphamide, doxorubicin, vincristine, and~     prednisone (CHOP) led for the first time to decline of the specific mortality.~      After treatment, patients with NHL experienced elevated risks for therapy-related leukemia,~     several solid tumors and late toxicities such as cardiovascular or neuro-psychiatric diseases~     which impact on quality of life. However little is known concerning long-term toxicity of~     this class of new agents so called targeted drugs such as anti-CD20.~      The primary objective of this cohort study is to estimate long term toxicity in NHL patients~     (i.e. 10 to 20 years) using data already collected (i.e. internal analysis) and to compare~     drugs consumption to that of controls (i.e. external analysis).~   "
54784|NCT02849899|"~     Post-transplant diabetes affects 15 to 20% of renal transplant patients and contributes to~     increased morbidity and reduced survival of transplants and patients. Corticosteroids,~     anti-calcineurin and mammilian Target OF Rapamycin (mTOR) inhibitors have a major~     diabetogenic impact and greatly contribute to the increase in diabetes prevalence after~     transplantation.~      There are to date few studies concerning the pharmacological prevention of post-transplant~     diabetes. Hecking et al. have recently reported that a short treatment with insulin,~     administered immediately after transplantation, reduce the incidence of de novo diabetes~     one-year post-transplant. This study included 50 renal transplant patients and showed that a~     three months treatment of (Neutral Protamine Hagedorn) NPH insulin decreased HbA1c. The~     occurrence of diabetes, a secondary end-point, was reduced by 73% in the treated group.~      No further pharmacological strategy has been developed to date. Relevant experimental~     evidences suggest that gliptins could be used in the pharmacological prevention of~     post-transplant diabetes. These drugs are inhibitors of dipeptidyl peptidase-4 (DPP-4), which~     inactivates the incretins, the glucagon-like peptide-1 (GLP-1) and the gastric inhibitory~     polypeptide (GIP). DPP-4 inhibition causes an increase in the GLP-1 and GIP concentrations~     which induce insulin secretion and inhibition of glucagon secretion. The gliptins are~     approved for the treatment of type 2 diabetes. Beyond the effects on blood glucose, gliptins~     have pleiotropic effects including a protective effect on β cells and anti-inflammatory~     effect.~      The additional cost associated with new-onset diabetes after transplantation could be also~     significantly reduced by efficient prevention. A US study found that, for the period between~     1994 and 1998, a newly diagnosed diabetic patient has cost $21,500 of medical expenses 2~     years after transplantation. Moreover, transplantation resulting in one of the best increases~     of patients' quality of life, its estimate is essential in the treatment evaluation of this~     population.~   "
54955|NCT02847663|"~     This study investigates the effects of whole-body cryotherapy vs. cold-water immersion after~     a muscle damage protocol.~   "
54785|NCT02849886|"~     This study evaluates the frequency of occurrence, severity, and response to treatment by a~     chemical agent, notably the dimerizer AP1903 (Bellicum Pharmaceuticals compagny), in the case~     of acute Graft versus Host Disease (aGvHD) occurring after the administration of~     T-lymphocytes expressing iCASP9 and concomitantly to a bone marrow graft depleted in B- and~     T-lymphocytes~   "
54786|NCT02849873|"~     The Absorption and Systematic Pharmacokinetics of IDP-123 Lotion in Comparison with Tazorac~     Cream.~   "
54787|NCT02849860|"~     Open-Label study designed to assess the safety and plasma PK of tretinoin and relevant~     metabolites after topical dermal application of IDP-121 lotion.~   "
54788|NCT02849834|"~     The primary aim of this study is to evaluate the induction of sensory-motor cortex plasticity~     after motor cortex stimulation in healthy subjects, using laser-evoked nociceptive cortical~     potentials, and in chronic neuropathic pain patients using functional MRI. As a secondary~     goal, the project will analyse possible correlations between the magnitude of cortical~     plasticity and that of the pain-relieving effect.~      In healthy subjects, cortical plasticity is evaluated by the comparison of somatosensory~     cortical maps before and after two isolated sessions of 20 Hz and theta-burst rTMS, in a~     cross-over randomized study.~      Two sessions of 5 consecutive days of rTMS are proposed to the patients with a minimum of 4~     weeks between the two sessions, defined by 20 Hz and theta-burst stimulation in a cross-over~     randomized order. Cortical plasticity of the motor cortex is evaluated via functional MRI~     (motor activation) performed before the first rTMS session and the last day of each session~     of rTMS.~   "
54789|NCT02849821|"~     This is a prospective, controlled and observational study. Participants underwent a 3-hour~     exposure to hypoxic conditions simulating an altitude of 4,000 meters above sea level~     (m.a.s.l.) in a hypobaric pressure chamber. Clinical parameters, as well as blood and stool~     samples and biopsies from the sigmoid colon (by sigmoidoscopy) are collected at subsequent~     time points. The investigators goal is to evaluate if a 3-hour stay at high altitude (4, 000~     m) can alter disease activity and can modulate a pro inflammatory reaction.~   "
54790|NCT02849808|"~     Corneal transplantation have been performed for several decades, follow-up time in some~     centers now exceeds 30 years. Published long term (10 years and up) graft survivals vary~     considerably from center to center. These variations may be explained by differences in~     case-mix and surgical techniques used.~      The investigators aim to better understand the factors associated with long term graft~     survival.~   "
54791|NCT02849795|"~     Body composition analysis and especially body fat distribution in regions of interest~     (android and in particular intra-abdominal region) provides some information on the risk of~     cardiovascular disease. There is little data available on the body composition analysis in~     psoriasis and psoriatic arthritis (diseases with higher risk of cardiovascular disease), in~     particular data on fat distribution in regions of interest regarding the risk of~     cardiovascular disease.~      Adipokines, secreted by the adipose tissue, have pro or anti-inflammatory and metabolic~     properties that are interesting to explore in pathologies with a higher risk of~     cardiovascular disease like psoriasis or psoriatic arthritis.~      Adipokines have been investigated in psoriasis but fat tissue and in particular its~     distribution (android/visceral or intra-abdominal) has not been studied in parallel.~     Moreover, relation between adipokines and psoriasis area or severity has been studied but the~     relation between adipokines and cardiovascular risk factors has not yet been investigated.~      The aim of this study is to investigate relations between the body fat distribution,~     adipokines rates and the risk of cardiovascular disease of these patients.~   "
54792|NCT02849782|"~     This prospective monocentric open label trial was realized in the Laboratory of Clinical~     Functional Exploration of Movement at the University Hospital of Besancon. Cognitive~     evaluations: 7 days before fampridine treatment initiation (Pre 1), on the day of fampridine~     treatment initiation (Pre 2), 14 and 21 days after fampridine treatment initiation,~     respectively Post 1 and Post 2. Gait evaluations were assessed at Pre 1, Pre 2 and Post 1.~      Fampridine was prescribed according to guidelines issued by the French Health Products Safety~     Agency at the dose of 10 mg twice daily. Fampridine is indicated for the improvement of~     walking in MS patients with a walking disability (EDSS 4-6.5). A walking test is recommended~     to evaluate improvement after 2 weeks of treatment. According to the practitioner evaluation~     between Pre 2 and Post 1 (i.e. before and after fampridine treatment), patients were~     classified into 2 groups: responders whose clinical status was improved and non-responders~     whose clinical status was not improved.~   "
54793|NCT02849769|"~     Following product approval, further confirmation of the MR Conditional Tachyarrhythmia~     Therapy Systems sensing and detection performance post MRI exposure will be obtained by~     actively monitoring de-identified device data obtained through the Medtronic CareLink®~     Network.~   "
54794|NCT02849756|"~     Estimate the future six months after the admission in an intensive care unit of the patients~     of 85 and more years old in terms of autonomy.~   "
54795|NCT02849743|"~     This research study will test if oxytocin, delivered by nasal spray, will promote weight loss~     in children, adolescents, and adults with Hypothalamic Obesity as compared to a placebo. The~     study is divided into two parts. During the first part, subjects will receive either oxytocin~     or placebo. In the second part, subjects will cross-over to receive the other treatment -~     either oxytocin or placebo. During study visits participants will do blood tests, physical~     exams, metabolic testing, a MRI scan, and some surveys and questionnaires.~   "
54796|NCT02849730|"~     In this retrospective study, postoperative pain score, epidural patient controlled analgesia~     (Epi-PCA) related complications, the risk factors for requirement of rescue analgesics and~     antiemetics will be evaluated in young and elderly patients, respectively, using fentanyl and~     ropivacaine-based Epi-PCA during postoperative 48 hours after various surgeries.~   "
54797|NCT02849717|"~     The purpose of this study is to see whether exercise can improve the health and well-being of~     patients scheduled to undergo surgery for a bowel related condition.~   "
54798|NCT02849704|"~     The objective of this study is to evaluate the malabsorption blood test (MBT), stool~     coefficient of fat absorption (CFA) and stool bomb calorimetry (BC) methods as potential~     screening or diagnostic tests for reduced exocrine pancreatic function or pancreatic~     insufficiency (RPF/PI). A further objective is to determine the test responses before and~     after pancreatic enzyme medication administration (Creon36™) in the patients with chronic~     pancreatitis (CP).~   "
54799|NCT02849691|"~     Dipeptidyl-peptidase-4 (DPP4) is an important regulator of incretins and inflammation, and~     participates in the pathophysiological process of acute myocardial infarction (AMI). However~     clinical data of DPP4a in AMI patients is sparse. This study was to investigate the role of~     plasma DPP4 activity (DPP4a) in patients with ST-segment elevation myocardial infarction~     (STEMI) treated with percutaneous coronary intervention (PCI). This was a analysis of~     consecutive patients conducted at a tertiary referral center from January 2014 to October~     2015. The investigators included 747 STEMI-patients, treated with PCI from January 2013 to~     October 2015. Blood samples were collected immediately at admission. The patients were~     divided into four groups according to DPP4a quartile.~   "
54800|NCT02849678|"~     This research study is testing whether the local anesthetic lidocaine is as effective as~     ropivacaine for post-operative pain control in continuous thoracic paravertebral nerve~     blocks. Ropivacaine and Lidocaine are FDA-approved drugs that has been successfully used in~     this hospital for post-operative pain control for the past few years, thus has become the~     standard drugs used for this nerve block. Lidocaine has numerous potential advantages over~     ropivacaine, such as faster onset of action, better safety profile and greater~     anti-inflammatory action. Catheters placed near both sides of a patient's spine for~     postoperative pain control are called thoracic paravertebral nerve blocks and are a part of~     routine care. Through those catheters, a numbing medication, or local anesthetic, to block~     the transmission of pain from the surgical incision to the spinal cord, thus reducing pain.~     The research part of the study is whether subjects will receive either the local anesthetic~     lidocaine or ropivacaine. The goal of this study is to determine whether the lidocaine~     controls pain better and facilitates a faster recovery after abdominal surgery than~     ropivacaine.~      In this research study, the investigators will compare patient-reported pain scores, any~     additional pain medication requirements for adequate pain control, time it takes for bowel~     function to return to normal following surgery, as well as the incidence of any side effects,~     such as numbness and weakness, subjects may experience between those receiving lidocaine~     versus those receiving ropivacaine. The investigators will screen 100 patients and enroll 60~     subjects into this study.~   "
54801|NCT02849665|"~     Introdution: The Kangaroo Mother Care is a perinatal care model for preterm and low weight~     newborn. The Kangaroo Position is the main feature of this method. The infant should be~     lightly dressed, in prone position and upright against the torax of the parents. Researches~     provides evidence that the Kangaroo Position induces an increase in myoelectric activity of~     preterm newborn. However, it is unknown how long the newborn should remain in the kangaroo~     Position so that ocurr changes in electromyographic. An increase in electromyographic~     activity was observed after 24 hours or more of submission to the Position Kangaroo, however~     period lower of submission to the Position Kangaroo have not been evaluated yet. Also unknown~     are the physiological mechanisms that cause this muscle response. One hypothesis would be the~     increase in temperature caused by skin to skin contact which could improve circulation in~     small vessels with direct influence on the infusion and nutrition of muscle tissue.~     Objective: Evaluate the immediate effect of Kangaroo position in the electromyographic~     activity and microcirculation of preterm newborn. Method: It will be a randomized and~     controlled trial from August 2016 to February 2017 with newborn preterm admitted at the~     Kangaroo Unit, IMIP. Newborns eligible according to the inclusion and exclusion criteria will~     be randomized into two groups: Kangaroo Group (experimental group) and Not Kangaroo Group~     (control group). The data of the electromyographic activity and the microcirculatory~     parameters will be assessed and recorded in three stages: before the Kangaroo position, one~     and three hours after of continuous submission in the Kangaroo Position (for the group of~     cases) and before the Kangaroo position, one and four after the three assessments (for the~     control group). In the control group, the preterm newborns will be not submitted to Kangaroo~     position until the completion of the last and third evaluation. The acquisition of the~     electromyographic signal will be conducted through an equipment electromyography Miotool 400®~     brand (Miotec Equipamentos Biomédicos - Brasil). To assess microcirculation will be used for~     the white light spectroscopy method through the drive moorVMS-OXY®. The project was submitted~     and approved by Ethics Committee for Research on Human Beings of IMIP (52381915.5.0000.5201).~     This study is part of a anchor project approved by Conselho Nacional de Desenvolvimento~     Científico e Tecnológico- CNPq (process 458163/2014-7).~   "
54802|NCT02849652|"~     Despite an overall reduction in US smoking rates from >50% in the 1960s to about 20% by 2000,~     the rate of smoking among persons with a serious mental illness (SMI) remains 2-3 times~     greater than in the general population. Further, even the recent small decline in smoking~     rates that has been reported in the general population in the past decade has not occurred~     among smokers with an SMI. In fact, 44% of all the cigarettes consumed in the US are by~     individuals with a psychiatric disorder and the primary cause of death among Americans with~     an SMI is a tobacco-related disease.~      This cluster randomized trial will be conducted in 14 Philadelphia community mental health~     clinics (CMHCs). Clinics will be randomized to either Addressing Tobacco Through~     Organizational Change model (ATTOC) or Usual Care (UC) treatment groups. The investigators~     hypothesize that 1) at the end of the intervention and at a 3-month follow-up, rates of~     adherence to guidelines for treating TUD will be greater among clinic personnel that receive~     the ATTOC intervention vs. clinic personnel in usual care; 2) at the end of the intervention~     and at a 3-month follow-up, rates of client smoking cessation will be significantly greater~     in clinics that receive the ATTOC intervention than among clients treated with usual care;~     and 3) using non-inferiority testing, at the end of the intervention and at a 3-month~     follow-up, there will be no significant degradation in mental health functioning or QOL among~     clients who receive care at clinics that received the ATTOC intervention than among clients~     treated with usual care.~   "
54803|NCT02849639|"~     The study will examine the impact on cognitive reserve of a pharmacist-physician~     patient-centered medication therapy management intervention to address inappropriate~     medication use as identified by the Beers 2015 list. By bolstering cognitive reserve, this~     project will directly address the National Alzheimer's Project Act 2015 priorities serving to~     delay onset of symptoms in preclinical dementia. The results of this study will provide~     valuable insights on how to expand this intervention to reduce the prevalence and associated~     healthcare costs of symptomatic Alzheimer's disease.~   "
54804|NCT02849626|"~     This is an open-label, multicenter study with an extension phase to evaluate the safety and~     tolerability of an perampanel oral suspension when administered as an adjunctive therapy in~     children (ages 4 to <12 years) with inadequately controlled partial onset seizures (POS) or~     primary generalized tonic clonic seizures (PGTC).~   "
54805|NCT02849613|"~     Stroke is the second leading cause of death in the world population. When not fatal, stroke~     often results in disability, and secondary health problems affecting not only patients but~     also their families. Building on emerging preclinical and pilot clinical evidences, RESSTORE~     will focus on the clinical assessment of regenerative cell therapy to improve stroke recovery~     and patients quality of life.~   "
54806|NCT02849600|"~     This is a retrospective cohort study with two specific aims. The first aim focuses on the~     treatment outcome of different VPT protocols in young permanent tooth. The second aim is to~     determine if MTA is a suitable material in VPT and related factors potentially influencing~     prognosis.~   "
54807|NCT02849587|"~     This study was authorized by the California Legislature (Assembly Bill 266, the Medical~     Marijuana Regulation and Safety Act (73) to help with detection of driving under the~     influence of cannabis. One hundred and eighty healthy volunteers will inhale smoked cannabis~     with either 0% (placebo), 5.9%, or 13.4% Δ9-THC at the beginning of the day, and then~     complete driving simulations, iPad-based performance assessments, and bodily fluid draws~     (e.g., blood, saliva, breath) before the cannabis smoking and a number of times over the~     subsequent 6 hours after cannabis smoking. The purpose is to determine (1) the relationship~     of the dose of Δ9-THC on driving performance and (2) the duration of driving impairment in~     terms of hours from initial use, (3) if saliva or expired air can serve as a useful~     substitute for blood sampling of Δ9-THC in judicial hearings and (4) if testing using an iPad~     can serve as a useful adjunct to the standardized field sobriety test in identifying acute~     impairment from cannabis.~   "
54808|NCT02849574|"~     To improve the management and risk reduction, it is essential to understand the evolution of~     the consumption of psychoactive substances, medicated or not in detention; it does not have~     at present no data on this subject. This work has as main objective to evaluate the~     development of substance use terms (goods and consumption practices) by the inmates between~     the period preceding their incarceration and their fifth month in detention.~   "
54809|NCT02849561|"~     With the repercussion of 55 cases eachyear for 100 000 inhabitants in France, cardio~     respiratory arrest is a public health issue.~      The goal of this study is to evaluate the pupillary light reflex measured by the dimension of~     the pupil (diameter) as a prognosis factor neurological evolution in post cardiac arrest. By~     participating to this study, the patient get the same tratments and exams than in a usual~     managing cares.~      In addition of these events, the pupillary light reflex is studied as soon as the patient is~     accepted in the department, and then on the second day.~      Currently, the evaluation of the neurological becoming rely on a multimodal clinical and~     paraclinical approach.~      The study of the pupillary light reflex measured by the diameter of the pupil could be a~     prognosis factor of neurological evolution for patients in post cardiac arrest, so a reliable~     and available prognosis marker in patient care.~      The goal of this study is to evaluate the pupillary light reflex (RPM), measured by the~     diameter of the pupil as a prognosis factor of neurological evaluation of admitted patients~     after a cardiac arrest.~      Principal criteria of judgement is the percentage of the pupillary light reflex variation~     measured with Neurolight®, compared between two groups.~   "
54810|NCT02849548|"~     The purpose of this study is to examine effects of blocking the orexin system with suvorexant~     after exposure-based intervention for posttraumatic stress disorder (PTSD) on sleep, PTSD~     symptoms, and intersession habituation.~   "
54811|NCT02849535|"~     The rise of oral targeted therapies favors outpatient care of cancer patients but exposes~     them to new risks compared to the injectable chemotherapy in the hospital: non-adherence to~     treatment, inappropriate management of side effects and interactions with other co-prescribed~     drugs. The clinical consequences (reduced efficacy and potentialized toxicity) are all the~     more important that ambulatory monitoring of treatments prescribed at the hospital remains~     underdeveloped due to default of coordination between these two settings.~      Adverse drug reactions are a major concern, as such, and because they involve prescription~     changes (dose reduction, treatment interruption). This results in a decrease in the dose~     taken and a risk of loss of efficacy.~      In the context of metastatic renal cell carcinoma, the risk of iatrogenicity is even higher~     because the oral targeted therapies available in this indication have a safety profile marked~     by potentially serious toxicities (hematologic and cardiac toxicity) or are known to reduce~     the treatment adherence (digestive and skin toxicities). In addition, these molecules are~     metabolized by the CYP3A4 hepatic cytochrome, which leads to avoid associating them with~     drugs inducing and / or inhibiting the CYP3A4, because of the risk of toxicity and / or loss~     of efficacy.~      The investigators propose to assess a program set up to secure drug taking by enhancing~     self-management of side effects and control of drug interactions by the patient. This program~     includes pharmaceutical visits and involves inpatient and outpatient (doctor, referent~     pharmacist and liberal nurse) professionals.~      The hypothesis of the study is that the PRISM care program will improve self-management of~     side effects by the patient, resulting in a relative dose intensity of oral chemotherapy~     improved compared to usual care.~   "
54812|NCT02849522|"~     This is a study protocol for the UK ROPE Register for Lower Urinary Tract Symptoms (LUTS).~     This register enables us to collect data on the treatment of LUTS using prostate artery~     embolisation (PAE), and other surgical methods to answer the following questions posed by~     NICE in 2013:~        -  Is PAE a safe and effective treatment option for LUTS caused by prostate enlargement?~        -  How does PAE compare with conventional surgical treatments? This will primarily be a~          surgical procedure called TURP (see below).~        -  Which patients would most benefit from PAE over the other treatment options? This is a~          pilot study, and the final register will contain data from roughly 100 patients for PAE~          and 100 patients for the other surgical interventions, allowing us to answer NICE's~          research questions, update NICE guidance documentation, and do further research with~          more patients if necessary.~      Our hypothesis is:~      • PAE produces significant improvements in the IPSS score 12 months post-procedure~   "
54813|NCT02849509|"~     The aim of this non-interventional study is to describe patient's perception of anticoagulant~     treatment when using Pradaxa® to prevent stroke and systemic embolism while suffering from~     atrial fibrillation (according to its approved indication in the approved dosages of 110 mg~     or 150 mg twice daily) in comparison to standard care using Vitamin K Antagonist (VKA).~   "
54814|NCT02849496|"~     This randomized phase II trial studies how well veliparib and atezolizumab work either alone~     or in combination in treating patients with stage III-IV triple negative breast cancer.~     Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Monoclonal antibodies, such as atezolizumab, may interfere with the ability of tumor~     cells to grow and spread. It is not known whether giving veliparib and atezolizumab either~     alone or in combination would work better in patients with triple negative breast cancer.~   "
54815|NCT02849483|"~     Ramosetron is effective in preventing postoperative nausea and vomiting. Several studies~     reported that ramosetron is also effective treatment of irritable bowel syndrome. The~     investigators examine the effect of ramosetron on postoperative bowel motility.~   "
54816|NCT02849470|"~     Purpose The primary objective of this study is to evaluate the safety and efficacy of the use~     of a biocellular mixture of emulsified adipose-derived tissue stromal vascular fraction~     (AD-tSVF) and high density platelet-rich plasma concentrate (HD- PRP) as compared with~     adipose-derived cell-enriched SVF (AD-cSVF) + AD-tSVF and HD- PRP concentrates in treatment~     of androgenetic alopecia (AGA) and Female Pattern Hair Loss (FPHL).~      Assigned Interventions~        1. HD-PRP + Matristem Matrix (ACell)~        2. Experimental: HD-PRP + Emulsified AD-tSVF~        3. Experimental: HD- PRP + Emulsified AD-tSVF + Emulsified AD-cSVF Device: Tulip~          Microcannula Closed Syringe For All Lipoaspiration (2.11 mm Diameter, offset Carraway)~          Centrifugation technique to acquire concentrated platelets (per manufacturer's approved~          protocol) Healeon ACM Emulsification System that prepares microcannula harvested AD-tSVF~          for small needle (25g) retrograde threaded intradermal scalp injection.~      Healeon Centricyte 1000 system for cellular isolation of AD-cSVF from AD-tSVF and testing by~     Flow Cytometry (ORFLO MoxiFlow) Procedure: Closed syringe microcannula lipoaspiration~     (AD-tSVF) Procedure: Emulsification of AD-tSVF via Healeon ACM Protocol (Newbury Park, CA,~     USA) Procedure: Biocellular mix of emulsified AD-tSVF and HD-PRP for intradermal injection in~     scalp; (Arm 2) Procedure: Cellular isolation (AD-cSVF) Centricyte 1000 incubation/shaker~     system using GMP certified, sterile Liberase MNP-S (Roche #06297790001) for enzymatic~     digestion manufacturer standard protocol. Creation of emulsified AD-tSVF + PRP +~     cell-enriched AD-cSVF for intradermal injection in scalp (Arm 3) Sham Comparator: No Fat~     Control using Emcyte II PRP Concentrate + Matristem (Acell) for subcutaneous scalp injection~     patterned per square centimeter of scalp. Procedure: Emcyte Pure PRP® II system to~     concentrate Platelets via using manufacturer standard protocol~   "
54817|NCT02849457|"~     Study design is a Phase IIb prospective multi-center, randomized, placebo-controlled,~     double-blind clinical trial. The goal will be to enroll 80 infants with Tuberous Sclerosis~     Complex who are less than 6 months of age prior to the onset of their first seizure~   "
54818|NCT02849444|"~     A prospective, multicentre, post-authorisation observational study. The objective of this~     study is assess the response of renal function in clinical practice to anti-multiple myeloma~     therapy in patients with relapsed MM and CrCl <50 mL/min/1.73 m2.~   "
54819|NCT02849431|"~     This study explores the feasibility of a mindfulness-based intervention for people with a~     diagnosis of borderline personality disorder.~   "
54820|NCT02849418|"~     This study will evaluate the efficacy and safety of GSK1358820 in Japanese patients with~     neurogenic detrusor overactivity (NDO) with urinary incontinence, whose symptoms have not~     been adequately managed with medications for urinary incontinence due to NDO.~      This study consists of a screening phase up to 28 days followed by a double-blind Treatment~     phase 1 of 12 to 48 weeks wherein subjects will receive a single treatment of either~     GSK1358820 200 Units (U) injection or placebo injection. After the first treatment, subjects~     who meet the re-treatment criteria between 12 to 36 weeks can enter an open-label Treatment~     phase 2 to receive a second treatment with GSK1358820 200 U. Subjects will be permitted to~     receive re-treatment up to 2 times, and there should be a gap of minimum of 12 weeks since~     the previous treatment. The duration of overall treatment phases is 48 weeks. The total~     duration of participation for any subject will not exceed 52 weeks, including screening.~   "
54821|NCT02849405|"~     Arteriosclerosis is a degenerative and dysmetabolic disease of the arterial walls. It is~     known to be the principal cause of coronary artery disease (CAD). Arteriosclerosis has an~     impact on the entire vascularization including the microvascularization. The retina is a~     nervous tissue that is supported by microvascularization. Therefore, systemic diseases that~     affect the nervous or the cardiovascular system are susceptible to have manifestations in the~     retina. Retinal signs associated to the risks to develop CAD (qualitative appreciation;~     diameter and appearance of arterioles) have been suggested. A quantitative approach would~     strengthen the interpretation of these evaluations.~      The Metabolic Hyperspectral Retinal Camera (MHRC) - the experimental instrument - has the~     capacity to identify and quantify a variety of biomolecules specific to the retina and the~     optic nerve.~      The purpose of this pilot study is to determine if the MHRC has the capacity to detect a~     specific hyperspectral signature in the retinal arterioles of subjects suffering from~     arteriosclerosis.~   "
54822|NCT02849392|"~     Research investigating beneficial effects of regular pistachio feedings on body composition~     (BC) and blood lipids are limited, and there are no studies that have investigated the~     effects of feeding pistachios on bone density or membrane incorporation of fats. The purpose~     of this study is to examine the effects of pistachio consumption on body composition, bone~     density, markers of bone turnover, erythrocyte membrane incorporation of fatty acids, lipid~     status, inflammatory markers, dietary quality/micronutrients and satiety using a cross-over~     study with two 12-week treatment periods (pistachio added (20 percent of kcals) and a~     no-pistachio control diet), separated by 15-week washout period. The investigators will~     recruit 30 female students from Cal Poly, San Luis Obispo (CP-SLO) and female 30 students~     from Cal Poly, Pomona (CP-P) facilitating a collaborative project and using the expertise of~     both Dr. Laura Hall (CP-SLO) and Dr. Bonny Burns-Whitmore (CP-P). The investigators hope to~     show the health benefits of pistachios as part of an overall healthy lifestyle.~   "
54823|NCT02849379|"~     The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to~     recurrent tongue cancer.~   "
54824|NCT02849366|"~     The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to~     recurrent sarcoma.~   "
54825|NCT02849353|"~     The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to~     recurrent ovarian cancer.~   "
54826|NCT02849340|"~     The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to~     recurrent cervical cancer.~   "
54827|NCT02849327|"~     The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to~     recurrent pharyngeal cancer.~   "
54828|NCT02849314|"~     The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to~     recurrent laryngeal cancer.~   "
54829|NCT02849301|"~     Preterm birth (PTB), defined as birth between 20 and 36 6/7 weeks, is responsible for the~     majority of the neonatal morbidity and mortality in the United States, and 35% of all U.S.~     healthcare spending on infants. Globally, about 28% of the 4 million annual neonatal deaths~     are directly attributable to PTB.~      Preterm labor (PTL) is the final pathway for about 50% of all PTB. Tocolytic agents are drugs~     that can slow or stop labor contractions in the attempt to delay births preceded by PTL.~     Primary tocolysis is defined as tocolysis given on initial presentation of women with PTL. In~     most of these women, PTL stops, but as their risk of PTB remains high, some have advocated~     use of maintenance tocolysis, i.e. tocolysis after arrested PTL. So far, no maintenance~     tocolytic agent has been shown to be beneficial in preventing PTB.~      The aim of this study is to evaluate the efficacy of maintenance tocolysis with Arabin~     pessary compared to standard care in singleton gestations with arrested PTL and with short~     transvaginal ultrasound (TVU) cervical length (CL) <25mm~   "
54833|NCT02849249|"~     The study was designed according to the draft of allergenic product regulation published by~     Spanish Regulatory Agency. The aim of the study is to evaluate the safety and tolerability of~     subcutaneous immunotherapy with polimerized (100/100) mixture of pollens: Olea europaea and~     Phleum pratense in patients with rhinoconjunctivitis with or without associated mild asthma.~     In addition, surrogate efficacy parameters will be evaluated: immunoglobulin level changes~     and skin reactivity.~   "
54834|NCT02849236|"~     Breast augmentation surgery can cause important postoperative pain, especially when bilateral~     subpectoral implants are used. The investigators hypothesized that a technique of regional~     analgesia, the pectoral nerve block type I (or PECS I block) would reduce pain within the~     first twenty-four hours and, in turn, morphine consumption and associated side effects. This~     is a randomized, controlled, double-blind study which compares intra and postoperative~     analgesia with or without PECS I block in breast surgery.~   "
54835|NCT02849223|"~     The primary aim of this study is to assess the magnitude of transcranial direct current~     stimulation (tDCS) -induced cognitive and functional change in patients with mild traumatic~     brain injury. This study will also attempt to identify biomarkers associated with treatment~     response. Last, acceptability and tolerability of procedures will be assessed. To accomplish~     these aims, a randomized, double-blind, sham-controlled, parallel groups, pilot study will be~     conducted in which participants are assigned to 24 sessions of tDCS or sham stimulation~     offered concurrent with working memory training. Neural efficiency will be measured with~     electroencephalogram (EEG) pre and post-intervention.~   "
54836|NCT02849210|"~     The study was designed according to the draft of allergenic product regulation published by~     Spanish Regulatory Agency. The aim of the study is to evaluate the safety and tolerability of~     subcutaneous immunotherapy with Olea europaea pollen extract in patients with~     rhinoconjunctivitis with or without associated mild asthma. In addition, surrogate efficacy~     parameters will be evaluated: immunoglobulin level changes and skin reactivity~   "
54837|NCT02849197|"~     Comparison of limited excision-primary closure, Limberg, and modified Limberg flap techniques~     for the surgical treatment of pilonidal sinus disease, each performed by a separate surgeon,~     in terms of postoperative outcomes and recurrence rates.~   "
54838|NCT02849184|"~     The purpose of this study is to compare the effectiveness and safety of suvorexant versus~     placebo on sleep pressure and circadian rhythm in hypertensives with insomnia.~   "
54839|NCT02849171|"~     This is a pilot study. The purpose of this study is to test if an imaging tracer, not~     approved by the FDA, called 18F-Fluorocholine (18F-FCH) is useful for evaluating this type of~     cancer. This tracer is used to perform PET scans. The researchers want to see if the 18F-FCH~     PET scan, using the study tracer 18F-FCH, can improve upon the usual scans at diagnosing or~     monitoring this type of cancer.~      In patients with high-grade gliomas, changes on standard MRI of the brain may reflect true~     tumor growth or inflammatory changes in response to treatment, called pseudo-progression. It~     is important to distinguish true tumor growth from inflammation since inflammation indicates~     the tumor is responding to treatment. With standard MRI, it is difficult to determine if~     changes following treatment are due to tumor growth or inflammation early on. Researchers~     hope to learn if the investigational tracer, 18F-FCH, will be able to distinguish true tumor~     growth from inflammation more accurately than standard MRI or 18F-FDG PET scans.~   "
54840|NCT02849158|"~     Single center interventional study to explore activity of fibroblasts in the tumor and away~     in the healthy rectal tissue.~   "
54841|NCT02849145|"~     Prospective, open labelled, monocentric trial to evaluation of the circulating tumor DNA rate~     in the blood, before and after curative resection of hepatic metastasis of uveal melanoma~     (HMUM) and during post-surgery follow-up~   "
54842|NCT02849132|"~     Patients who have completed 2-years entecavir-based treatment in Regress Study will receive~     another 5-years entecavir extension therapy. Patients will be assessed at baseline and every~     six months for blood cell count, liver function test, HBVDNA, AFP, prothrombin time, liver~     ultrasonography, and Fibroscan; A third liver biopsy will be performed at year 3 in patients~     who have significant fibrosis at second biopsy. CT and endoscopy will be performed at~     baseline and year 3.~   "
54843|NCT02849119|"~     Both laparoscopic partial nephrectomy (LPN) and robotic partial nephrectomy (RPN) can be~     performed through transperitoneal (TP) or retroperitoneal (RP) approach. RP approach is less~     utilized than TP approach because of technical difficulties when using rigid laparoscopic~     instruments in the small space of retroperitoneum cavity. However, with advanced surgical~     skills and thoughtful patient selection, RP approach may be associated with shorter operative~     time (OT), less estimated blood loss (EBL), shorter length of hospital stay (LOS) compared~     with TP approach.~      Therefore, the investigators performed randomized control trial to compare the outcomes of~     the two approaches (TP-LPN or RPN vs RP-LPN or RPN).~   "
54844|NCT02849106|"~     Prospective, open labelled, multicenter trial to evaluate the feasibility of ex vivo culture~     3D (chemogram obtaining) on biopsies in order to estimate the predictive value of this~     technique for treatment response in patients treated by two different chemotherapies (FOLFOX~     or FOLFIRI) for colorectal cancer.~   "
54845|NCT02849093|"~     The primary aim of the study is to investigate whether optical coherence tomography (OCT) may~     be a useful tool for investigating the in-vivo histology of ocular structures in patients~     with tear film pathology. In epiphora the investigators will image the proximal lacrimal~     system. In dry eye syndrome the investigators will image the lacrimal gland and also the~     buccal mucosa.~      The secondary aim of the study is to investigate the appearance of the normal cornea and~     conjunctiva under OCT imaging.~   "
54846|NCT02849080|"~     This trial is globally conducted. The aim of this trial is to investigate Efficacy and Safety~     of Oral Semaglutide Using a Flexible Dose Adjustment Based on Clinical Evaluation versus~     Sitagliptin in Subjects with Type 2 Diabetes Mellitus.~   "
54847|NCT02849067|"~     It is known that laughter can bring benefits in terms of physiological and psychological~     parameters, in addition to improving the individual's quality of life. However, the~     literature is still scarce as to the existence of studies investigating the effects of a~     comedy film specifically in hemodynamics.~   "
54848|NCT02849054|"~     To determine the appropriate volume (size) of ventilator breath during volume-targetted~     ventilation for infants born with congenital diaphragmatic hernia.~   "
54849|NCT02849041|"~     Tobacco smoke is the most common source of exposure to carcinogens in humans. Indeed, the~     smoke contains about 1010 particles per ml and 4800 chemical compounds, at least 66 are~     carcinogenic. Tobacco smoke is the leading preventable cause of cancer in humans since it is~     responsible for lung cancer, upper aerodigestive tract (mouth, pharynx, larynx, esophagus),~     nasal cavity and sinuses, stomach, pancreas, liver, bladder, kidney, uterine cervix, and some~     myeloid leukemias.~      This study aims to evaluate the combined effect of the scanner and the search for circulating~     tumor cells (CTC) on screening for tobacco-related cancers, accompanying smokers to cessation~     and addressing the psychological impact this approach.~   "
54850|NCT02849028|"~     Microbiome studies may be highlighted as crucial in the development of sleep disorder for TBI~     patients. The microbiota-gut-brain connection may further provide an opportunity for~     microbiota manipulation to treat the TBI patients with sleep disorders.This study is to~     investigate whether exist the relationship between sleep disorder and circadian rhythm of~     patients with TBI or not and focus the study on the potential of the host-microbiota~     interaction in regulating sleep disorder.~   "
54851|NCT02849015|"~     The aim of this study is the safety and efficacy of cryosurgery plus natural killer(NK)~     immunotherapy to tumors in transplanted liver.~   "
54852|NCT02849002|"~     The primary objective of this study is to collect un-blinded BrainPulse recordings from youth~     and adults that have a confirmed diagnosis of concussion per protocol guidelines in order to~     improve a concussion detection algorithm previously developed by Jan Medical, Inc. Subjects~     will be followed for 21 days after the initial injury with BrainPulse recordings to study the~     subject's recovery process. The symptomatic evaluation, physical examination, and BrainPulse~     recordings will be entered in a database to assess clinical outcome and device~     utilization.BrainPulse(TM)~   "
54853|NCT02848989|"~     Studies have shown that on-going pain following breast surgery is common and may limit the~     ability to participate in physical activity, cause tiredness, difficulty in daily~     chores/activities as well as other problems.~      This study is evaluating whether participating in a 12-week Qigong program (pronounced chee~     kung), an exercise program that involves gentle movements combined with breathing/relaxation~     techniques, also known as mind-body exercise, leads to improvement of pain, physical~     function, and quality of life among breast cancer survivors that have significant pain~     following surgery.~   "
54854|NCT02848976|"~     Regular physical activity promotes physical and mental well-being in the general population.~     Patients with multiple sclerosis (MS patients) tend them, to limit their physical activity or~     because of deficiencies related to the disease, or even on the advice of their caregivers in~     order to save their functional abilities. Time for leisure activity could be almost 20% lower~     in MS patients compared to healthy controls, and this situation is likely to aggravate the~     functional symptoms of multiple sclerosis.~      The literature described the benefit of physical activity for MS patients according to~     protocols and varied assessments. Evaluations were indeed concern very analytical elements of~     metabolic functioning, nervous, muscular, cardiopulmonary etc ... or take into account the~     performance of components or fatigue and quality of life. Due to the multiplicity of RE~     protocols, sometimes on the verge of pragmatic goals of functional rehabilitation, the double~     issue was the profit earned by an RE program and of this benefit by level of severity of MS.~     The main objective of our study was an evaluation of the effects on fatigue and quality of~     life of a retraining program to effort suitable for levels of impairment and patients with MS~     activity limitations. The secondary objective was checking a performance improvement of the~     patients in this adapted program.~   "
54855|NCT02848963|"~     ASA I-II 3-12 years old children participated to this study. All Participants will divide~     into the three groups. In Groups I, 2,5 mg/kg propofol and 0,5 mg/kg ketamine will apply at~     anaesthesia induction. General anaesthesia will be performed with 5/1 ratio of~     ketamine-propofol mixture with %67 of Mcfarlan dose regiment.~      In Groups II, 2,75 mg/kg propofol and 0,41 mg/kg ketamine will apply at anaesthesia~     induction. General anaesthesia will be performed with 6,7/1 ratio of ketamine-propofol~     mixture with %80 of Mcfarlan dose regiment.~      In Groups III, 3 mg/kg propofol and 0,3 mg/kg ketamine will apply at anaesthesia induction.~     General anaesthesia will be performed with 10/1 ratio of ketamine-propofol mixture with %90~     of Mcfarlan dose regiment.~      After than surgical operation recovery time, PAED scores, FLACC scores, Staying time in PACU~     will be recorded. These data will be evaluated with statistically.~   "
54856|NCT02848950|"~     The basis for obesity's impact on reproduction is not well characterised and there is a~     controversy whether the key organ influenced by it are the ovaries or the uterus.~      Insulin sensitizers ameliorate insulin resistance in obese patients. This study seeks to~     determine if Metformin helps to increase fecundability by affecting the uterus in women~     undergoing ART. As a surrogate marker- flows in the uterus will be tested during the~     treatment.~   "
54857|NCT02848937|"~     This study aimed to evaluate the effect on the calcium balance of a concentrate with 1 mM~     citrate and locate the equivalent concentration of calcium (Ca_eq) at a concentration of 3 mM~     acetate and traditional with 1.5 mM calcium in HD. The secondary objective is to evaluate the~     performance in the medium term of purifying the concentrate with 1 mM citrate and Ca_eq,~     compared to traditional concentrated with 3 mM acetate and 1.5 mM calcium in HD.~   "
54858|NCT02848924|"~     Fractures of the acetabulum and pelvis are serious injuries to vital prognostic can play in~     cases of severe bleeding. In all cases the functional is a major issue with a potential reach~     of walking ability and maintaining the seated and standing positions. The treatment of such~     lesions requires management to a specialist, or the ability to use such centers for advice or~     transferring patients. This organization was recommended after the symposium of the French~     Society of Orthopedic Surgery (SOFCOT) in 2009. With the aging population, the incidence and~     clinical features of these fractures have evolved to worsening the functional prognosis. Club~     Basin acetabulum, body SOFCOT, wants to achieve an observational study assessing needs and~     practices at national and regional level. The long-term objective is to propose a regional~     organization of care of these patients in order to reduce morbidity and mortality associated.~   "
54859|NCT02848911|"~     The purpose of the study is to determine the maximum tolerated dose (MTD) in patients with~     acute lymphoblastic leukemia (ALL) and to determine the safety and tolerability of increasing~     doses and different infusion times of AFM11 infusion in patients with adult B-precursor ALL~   "
54862|NCT02848872|"~     The hypothesis of this study is that functional tumor infiltrating lymphocyte (TIL) isolation~     from resected lung cancer specimens is feasible, allowing determination of tumor~     antigen-specific T cell reactivities. The primary objective of this study is to investigate~     the feasibility of isolating functional tumor infiltrating lymphocytes s(TILs) to determine~     tumor antigen-specific T cell re-activities in 30 resected lung tumor specimens. Successful~     isolation of TILs will be defined as collecting 1x10-6 viable, CD45+ mononuclear cells or~     greater from tumors containing >/=1 gram of excess tissue. If successful isolation of TILs~     can be obtained from >/= 66% of resected tumor specimens, the protocol will be considered~     feasible. The primary exploratory objective is to identify immunologic signatures that~     predict clinical outcomes from cytotoxic chemotherapy and/or immunotherapy.~   "
54863|NCT02848859|"~     This is a pilot study randomizing patients with insomnia and coronary heart disease to either~     general sleep hygiene counseling and web-based cognitive behavioral therapy for insomnia~     versus general sleep hygiene counseling alone (followed by the cognitive behavioral therapy~     at a later date).~   "
54864|NCT02848846|"~     The NEBIAS (NEurocontrolled BIdirectional Artificial upper limb and hand prosthesiS)~     proposal aims at developing and clinically evaluating (in selected amputees) a~     neuro-controlled upper limb prosthesis intuitively controlled and felt by the amputee as the~     natural one. This will be possible by means of a novel neural interface able to provide a~     stable and very selective connection with the nervous system. This goal will be achieved by~     combining microtechnology and material science and will allow, on one side, recording of the~     motor-related signals governing the actions of the amputated hand/arm for the motion control~     of a mechanical prosthesis, and on the other providing sensory feedback from tactile and~     kinesthetic sensors through neuromorphic stimulation of the adequate afferent pathway within~     the residual limb. The NEBIAS proposal is also aimed at finding out the 'language'~     intrinsically linking central nervous system with peripheral nerve signals in order to govern~     simple and complex hand/fingers movements. To reach this goal, a variety of techniques~     exploring brain and nerve functions will be assembled and integrated; this includes the~     analysis of electromagnetic brain and nerve signals, as well as of movement-related changes~     in brain's blood flow/metabolism.~   "
54865|NCT02848833|"~     To monitor the safety profile and effectiveness of Empagliflozin in Korea patients with type~     2 diabetes mellitus in a routine clinical practice setting~   "
54866|NCT02848820|"~     OBJECTIVE~      The aim of this study is to compare the effectiveness of initial non-operative treatment~     strategy (reserving appendectomy for those not responding or with recurrent disease) with~     immediate appendectomy in children from 7 to 17 years old, inclusive, with acute simple~     appendicitis in terms of complications, health-related QOL and costs.~      Main research question: What is the difference in proportion of patients experiencing~     complications within 1 year between both strategies in children from 7 to 17 years old,~     inclusive, with acute simple appendicitis?~   "
54867|NCT02848807|"~     Determine whether nutritional support with high protein ONS in adult oncologic patients in~     the first step of cancer cachexia - asymptomatic precachexia, influence on the toxicity of~     systemic therapy.~   "
54868|NCT02848794|"~     The study is aimed to evaluate the efficacy and safety of Apatinib and Irinotecan in patients~     with recurrent high-grade glioma.~   "
54869|NCT02848781|"~     The current standard of care for ventricular tachycardia (VT) includes the use of medicine~     called anti-arrhythmic drugs (AADs) and Implantable Cardioverter Defibrillator (ICD) therapy.~     These treatments are used to terminate the irregular heartbeats and bring the heart back to a~     normal rhythm. Catheter ablation is a procedure used to eliminate (damage) the heart cells~     causing the arrhythmia. Patients eligible for this may benefit from an ablation procedure in~     addition to an ICD to treat their VT condition or risk of developing VT. This study aims to~     show that treating VT with catheter ablation, if performed preemptively at the time of ICD~     implantation, will reduce subsequent recurrent VT, ICD shocks, and lead to improved survival.~   "
54870|NCT02848768|"~     The purpose of this study is to validate of a predictive nomogram of response or resistance~     to targeted therapies in metastatic clear cell renal cell carcinoma~   "
54871|NCT02848755|"~     Neonatal cranial ultrasound (US) remains the method of choice to detect brain injury in high~     risk preterm infants on neonatal intensive care units (NICU). It is a non-invasive,~     inexpensive bedside tool and examinations can be repeated as often as necessary without major~     disturbance of vulnerable infants. The anterior and posterior fontanelles from excellent~     acoustic windows to examine the deep midline and periventricular regions of the brain.Some~     data demonstrated that cerebral palsy can be accurately predicted with US. However, cranial~     US is not very suitable for investigating cortical regions or structures in the posterior~     fossa. There is limited data for very preterm infants.The investigators aimed to measure~     ventricular index, cranial height, biparietal diameter and calculate brain volume in a huge~     number of infants.~   "
54872|NCT02848742|"~     Study to evaluate the ability of the Dermal Cooling System to reduce pigmentation in benign~     pigmented lesions.~   "
54873|NCT02848729|"~     This study is to test the hypothesis that an opioid used to treat postsurgical pain, IV~     morphine, will impact the absorption of coadministered oral acetaminophen and result in~     altered pharmacokinetics in healthy subjects.~   "
54874|NCT02848716|"~     This is an international, prospective, multicenter and randomized phase III study designed to~     determine if patients with locally advanced cervical cancer have longer overall survivals~     with pretherapeutic paraaortic surgical staging when compared to radiologic staging.~   "
54875|NCT02848703|"~     Myocardial perfusion is a major parameter characterizing the status of capillary circulation~     of the myocardium. Its quantification is possible using Magnetic Resonance Imaging (MRI)~     during the 1st pass of a contrast agent through the capillary system. This technique is~     radiation-free, but it is difficult to repeat measurements during a single exam. Also, a~     number of patients suffering from cardiac disease cannot receive contrast agent injections.~     The investigators have developed a totally non-invasive approach for quantifying myocardial~     perfusion. It is based on the magnetic labeling of arterial spins. Flowing into the~     capillaries (Arterial spin labeling, ASL).~      Goal : The major goal of this research protocol is to validate a totally non-invasive method~     of myocardial blood flow quantification using MRI without contrast agent injection~   "
54876|NCT02848690|"~     This parallel, randomized clinical trial will include 120 participants. They will be~     allocated to a sodium restriction educational intervention or usual care groups. The~     educational intervention will be planned based on the DSRQ application and sessions will be~     conducted once a month for the period of six months. Both spot urine collection to estimate~     sodium intake and the DSRQ will be applied at the baseline, in the eighth week and at the end~     of the follow-up. Blood sample and 24-hour ambulatory blood pressure monitoring (ABPM) will~     be conducted at the beginning and at the end of the follow-up. Anthropometric measurements,~     blood pressure measurement and 24-hour food recall will be collected during follow-up.~   "
54877|NCT02848677|"~     Cardiovascular disease (CVD) is considered the main cause of mortality in the western world.~     There are many factors that contribute to the onset and progression of cardiovascular~     disease, including hypertension. Hypertension is a multi-factorial condition that includes~     nutritional disorders in its causality line. It is believed that advanced glycation~     end-products (AGEs) is one of the pathophysiological causes that explain the occurrence of~     high blood pressure in diabetic patients. This study has the role of describing the protocol~     of a randomized clinical trial aiming to evaluate changes in serum levels of end products of~     advanced glycation after an intervention for eating habit changes in hypertensive~     individuals.~      The investigators designed a randomized clinical trial, with non-blinded assessment of~     outcomes. Participants will be recruited from the outpatient clinic for hypertension of a~     public hospital in Porto Alegre, aged from 40 to 80 years old and without diabetes.~     Hypertension is defined as systolic blood pressure ≥ 140 mmHg, diastolic blood pressure ≥ 90~     mmHg, or antihypertensive medication use. Participants will be assigned to one of two groups.~     The intervention group will receive monthly educational intervention sessions for low salt~     diet, high in fruits and vegetables, and low in processed foods for a period of 6 months.~     Besides these, the intervention group will receive a standard telephone interview every two~     weeks to motivate them to follow the diet. The control group will receive the usual~     counseling for low sodium diet in monthly appointment with a dietitian, following the~     hypertension care clinic protocol.~      This study aims to investigate if there are significant changes in serum levels of advanced~     glycation end products, after the nutritional intervention with diet guidance in fruits,~     vegetables, low in sodium and processed foods in hypertensive patients because several~     studies have shown that less processed food rich in antioxidants with low sodium content,~     play an important role in reducing levels of AGEs which are precursors of vascular~     inflammation and progression of cardiovascular diseases.~   "
54878|NCT02848664|"~     The purpose of this study is to develop appropriate training methods and gather participant~     feedback on their use of the Passy Muir Swallowing Self-Training Device (PMSST). The PMSST is~     a small device that provides external vibratory stimulation to the larynx during swallowing~     and swallowing training. A secondary purpose of the study is to determine how 3 months of use~     of the PMSST affects swallowing physiology, brain activation, oral intake and quality of~     life. This was an uncontrolled pilot study aimed at gaining patient feedback on use of the~     vibratory device.~   "
54879|NCT02848651|"~     This is a Phase II, open-label, prospective, multicenter study designed to evaluate the~     efficacy and safety of single-agent atezolizumab as a first-line therapy in participants with~     locally advanced or metastatic non-small cell lung cancer (NSCLC). In addition, the primary~     biomarker objective is to measure blood tumor mutational burden (bTMB) and evaluate whether~     it can predict for improved clinical outcome with atezolizumab.~   "
54880|NCT02848638|"~     The primary goal of the study is to see if the PET/CT will be able to determine the precise~     location of the Y-90 particles within the liver and within the tumors. We hope to use this~     information in order to see if these particles distribute evenly throughout large tumors or~     if the particles go into the tumor which is located in the portal vein.~      The secondary goals are threefold. First correlate the distribution of Y90 particles (as~     demonstrated by PET/CT) with the degree of dead-tumor tissue. Second, see if there is a~     difference in the Y90 particle's distribution when a low particle load (1-3 million~     particles) is used compared to when a high particle load (6-8 million particles) is used.~     Lastly, compare the sensitivity of standard imaging ( bremsstrahlung imaging) currently being~     used for the Yttrium-90 angioembolization procedure to the sensitivity of the pair production~     PET research imaging.~   "
54881|NCT02848625|"~     This study will evaluate whether regular yoga exercises designed specifically for patients~     with Idiopathic Pulmonary Fibrosis is associated with any change in quality of life. Half of~     the participants will be randomized to yoga, half to usual care. After the first group~     completes 12 weeks of yoga, the patients who were randomized to usual care will completed 12~     weeks of yoga.~   "
54882|NCT02848612|"~     To prevent thromboembolic complications, the embolization procedure is performed under~     prophylactic unfractionated heparin, the efficacy of which is monitored by point-of- care~     testing according to international guidelines. However, these guidelines are based on limited~     scientific evidence and the ideal level of anticoagulation required has not been precisely~     defined. Furthermore, the correlation between the point-of- care tests used at Amiens~     University Hospital and the reference methods used in the laboratory varies considerably~     according to the available literature.~   "
54883|NCT02848599|"~     The purpose of this study is to determine whether epidural levobupivacaine applied for the~     purpose of post-operative analgesia compared to systemic analgesia with morphine leads to~     better pain control, stronger suppression of the inflammatory response and the production of~     inflammatory mediators, faster recovery of patients and consequently less incidence of~     postoperative cognitive dysfunction (POCD) in elderly patients after surgical treatment of~     femoral fractures.~   "
54884|NCT02848586|"~     The purpose of this study is to determine if using e-cigarettes (ECIG) rather than regular~     tobacco cigarettes alters lung inflammation in people with and without HIV. The study is also~     interested in asking subjects their opinion on the use of ECIG and how they make them feel.~     This study is for research purposes only and is not intended to treat asthma or HIV or to~     modify tobacco use.~   "
54885|NCT02848573|"~     we propose this study and try to find out possible clinical applicable non-invasive imaging~     indices or its combination with the laboratory indices to predict the status of hepatic~     fibrosis in BA patients.~   "
54894|NCT02848456|"~     This study investigated the effects of spinal manipulation on central nervous system~     activity. The presence of postactivation potentiation, an increase in muscular force~     production following prior muscular contractions, was measured with electromyography and the~     muscular force production during electrically-induced calf muscle reflexes. It was~     hypothesized that significantly greater potentiation would be stimulated by a calf muscle~     contraction with spinal manipulation delivered immediately beforehand than the potentiation~     arising from the contraction only.~   "
54895|NCT02848443|"~     The main purpose of this study is to assess the safety and tolerability and to determine the~     recommended phase 2 dose of S 95005 given in combination with oxaliplatin in patients with~     metastatic colorectal cancer.~   "
54956|NCT02847650|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of PF-06649751~     in Parkinson's disease patients at early stage of the disease.~   "
54886|NCT02848560|"~     This is an observational study for children with Cystic Fibrosis (CF) who are eligible based~     on their CF gene type. One group will be called the treatment group because they have the~     gene type (homozygous F508del) that makes them clinically eligible through their CF care~     provider to begin treatment with the new FDA approved CF drug called orkambi. For the control~     group, children will be enrolled who have a similar CF gene type (heterozygous F508del) but~     are not eligible to be prescribed orkambi.~      The two groups will be followed for four visits over about 3 to 4 years to observe changes in~     the lungs. Methods to measure the changes in lung disease will include:~      MRI with non-FDA approved inhaled xenon gas to take detailed images of the lungs, Pulmonary~     Function Tests (PFT), Lung Clearance Index (LCI), Baseline CT image of the lungs if not~     ordered as part of usual clinical care.~      The first two visits will be done before starting clinical treatment with orkambi and will be~     a minimum of 28 days apart and up to 18 months. The third visit will be scheduled about 3~     months after starting orkambi and the fourth visit about 18 months later. For the control~     group, the timing of visits will be similar to treatment group and visits may be scheduled~     around annual CF care visits.~   "
54887|NCT02848547|"~     An extended follow-up study of NCT00819455 conducted 5 years post randomization. In this~     study we estimate the incidence of type 2 diabetes among participants enrolled in the~     diabetes prevention programme. This will provide comparison of the progression to diabetes~     among group motivated through text messages and the group educated only during enrollment. A~     total of 537 participants were enrolled in the primary study and are invited to participate~     in a follow-up visit 3 years post active trial period.~   "
54888|NCT02848534|"~     The gold standard for diagnosing a bacterial infection is isolation of the pathogenic germ,~     which is not easy in routine clinical practice.~      Conventional markers do not have sufficient diagnostic value for making a rapid diagnosis on~     admission. A 2004 literature calculated the diagnostic values of C-reactive protein (CRP) and~     procalcitonin (PCT) levels for the diagnosis of bacterial infections, relative to other~     causes of inflammation. For CRP, the sensitivity was 75% (95% CI: 62%-84%) and the~     specificity was 67% (95% CI: 56%-77%). For PCT, the sensitivity was 88% (95% CI: 62%-84%) and~     the specificity was 81% (95% CI: 67%-90%).~      The first cellular immune response to infection consists of the mobilization of polynuclear~     neutrophils from the bone marrow to the infection site under the effect of pre-inflammatory~     cytokines, as well as the apoptosis of lymphocytes and their sequestration at the infection~     site. This results in lymphopenia and the elevated polynuclear neutrophil count (PNN)~     observed in bacterial infections.~      Hence, it is legitimate to hypothesize that the neutrophil to lymphocyte ratio (NLR) can be~     used in the diagnosis of bacterial infection. This ratio's value in the diagnosis of sepsis~     in the emergency department was studied and the researchers found higher diagnostic values~     than for CRP and PCT.~      The NLR's potential value in the diagnosis of a bacterial infection in a context of fever or~     hyperthermia (regardless of the presence or absence of bacteraemia) has not been studied~     before. This ratio could also be compared with standard biomarkers (CRP and PCT levels, the~     white blood cell count and the PNN).~   "
54889|NCT02848521|"~     This is a prospective, non-interventional study (NIS) measuring health-related quality of~     life (HRQoL), treatment satisfaction, and other patient-reported outcomes (PROs) of ADPKD~     patients in Europe.~   "
54890|NCT02848508|"~     To validate on the mid-term in moderate and severe renal failure (CKD 3-4) a nomogram to~     adapt a fixed metformin daily posology according to renal function on the basis of the first~     short-term study made by the investigators.~   "
54891|NCT02848495|"~     Intracranial aneurysm (IA) is an asymptomatic cerebrovascular abnormality affecting 3.2% of~     the general population. The devastating complication of IA is its rupture, resulting in~     subarachnoid haemorrhage that can lead to severe disability and death.~      Unfortunately, there are neither reliable clues nor diagnostic tools to predict the formation~     and/or the fate of an IA in a given individual. Also, there is no pharmacological drug~     available to prevent the rupture of aneurysm and subsequent subarachnoid haemorrhage. Current~     treatments are invasive with a significant risk of procedural morbidity. Thus, still now, the~     management of patients with IA remains extremely challenging and still controversial.~      Although the pathogenesis of IA has been the subject of many studies for the last decade, the~     mechanisms underlying IA formation, growth and rupture are still mostly unknown and relevant~     animal models of IA are not available.~      Familial history of IA predisposes to IA formation and rupture and increasing evidence~     suggest a genetic component of IA formation, with heterogeneous modes of inheritance and~     penetrance.~      This project, gathering neuroradiologists, geneticists and vascular biologists, addresses the~     urgent need to understand the pathogenic mechanisms of IA to develop diagnostic and~     predictive tools of risk of IA.~      The investigators propose to identify IA-causing variants by whole-exome sequencing in~     familial forms of the disease.~      The investigators hypothesises that the functional analysis of the causal / susceptibility~     variants thus identified will provide clues to understanding the pathological mechanisms of~     IA formation, and the bases for developing diagnostic tools. This project aims at meeting~     this challenge. Based on preliminary data that already allowed to identify such a variant,~     and the combination of genetic and functional investigations, the specific objectives of this~     project are: - To identify IA-causing variants in familial forms of the disease by~     whole-exome sequencing; - To understand the function of these genes/ variants in the~     formation and rupture of IA by molecular and cellular approaches and generation of relevant~     animal models; - To discover potential biomarkers of risk of IA formation and/or rupture.~   "
54892|NCT02848482|"~     Photodynamic therapy (PDT), also known as photoradiation therapy, phototherapy, or~     photochemotherapy, involves the use of a photoactive dye (photosensitizer) that is activated~     by exposure to light of a specific wavelength in the presence of oxygen. In recent years, PDT~     has been introduced as an important novel disinfection therapy in the field of implant~     dentistry. The inactivation of microorganisms using PDT has been defined as antimicrobial~     PDT. PDT has the potential to be an alternative of antibiotics, especially for the treatment~     of localized infections and oral biofilm. PDT is unlikely to cause bacterial-resistance and~     is equally effective against antibiotic-resistance and antibiotic-susceptible bacteria.~      Inconsistent results have been reported regarding the potential role of PDT as an adjunct to~     mechanical debridement in the management of peri-implant infection. Thus, the aim of the~     present trial is to investigate the treatment effect of non-surgical treatment with and~     without photodynamic therapy on initial peri-implantitis.~   "
54893|NCT02848469|"~     The Irish Omega-3 study is a clinical trial designed to investigate the potential of Omega-3~     fatty acids in the reduction of risk of psychosis.~      The study is being coordinated by the HRB Clinical Research Facility at University College~     Cork. The Principal Investigator is Dr Maeve Rooney, Consultant Psychiatrist in the Mercy~     University Hospital, Cork. The study will be carried out in collaboration with the HRB~     Clinical Research Facility in Dublin in prior to rolling out to other centres around Ireland.~      The Study is funded by Stanley Medical Research Institute, a non-profit organization~     supporting research on the causes of, and treatments for, schizophrenia and bipolar disorder.~     It is the largest provider of funding for research in serious mental illness outside of the~     U.S. government.~   "
54896|NCT02848430|"~     Human safety studies will be carried out to test whether hop botanical dietary supplements~     used by peri- and post-menopausal women are safe to use with Food and Drug Administration~     (FDA)-approved drugs. To test this, a hop dietary supplement (previously tested in women at~     the University of Illinois at Chicago without any harmful effects) will be given with four~     selected FDA-approved drugs to determine if the hop supplement can increase or decrease how~     these medications are absorbed, metabolized and excreted by the human body. Preclinical~     studies predict that the hop supplement might affect the metabolism or break down of these~     probe drugs.~   "
54897|NCT02848417|"~     The investigator proposes to perform a phase I/II study comparing two nutraceuticals and~     placebo that target mediators identified in the investigator's prior dynamic modeling study~     of Gulf War Illness (GWI). The investigator will repeat the dynamic modeling before treatment~     and on therapy to assess the modeling and the impact of the interventions on the homeostatic~     networks that have identified, with an added focus on the glutathione/redox system.~   "
54898|NCT02848404|"~     The purpose of this study is to examine therapeutic efficacy of catergorical language fluency~     smartphone game apllication in mild congnitive imapirment and mild Alzheimer's dementia.~   "
54899|NCT02848391|"~     Aim of this study was to evaluate the hypoxic response during hypobaric flight simulation in~     normal individuals as well as in normocapnic and hypercapnic COPD patients as well as to~     evaluate the impact of a flight simulation on walking endurance in these patients.~   "
54900|NCT02848378|"~     This study investigates the levels of advanced oxidation protein product and monocyte~     chemoattractant protein-1 in gingival crevicular fluid in periodontal disease and health. 25~     participants with chronic periodontitis, 25 participants with gingivitis and 25 periodontally~     healthy subjects are included into this study. In each participant, four sites are identified~     for gingival crevicular fluid samples.~   "
54901|NCT02848365|"~     Postoperative sore throat (POST) is a common problem following the use of endotracheal~     intubation during general anaesthesia. It leads to dissatisfaction and discomfort after~     surgery and can delay a patient's return to normal routine activities. POST has been rated by~     patients as the eighth most adverse effect in the postoperative period. The incidence of sore~     throat after endotracheal intubation varies from 14.4-90%. Laryngoscopy and tracheal~     intubation also leads to hemodynamic stress response. The response can be deleterious in~     patient with or without cardiac disease. It is related to the degree of manipulation of the~     airway during endotracheal intubation and has been studied during intubation for some~     equipment used for endotracheal intubation~   "
54902|NCT02848352|"~     The study aimed at identifying whether different expectations have an impact on experiencing~     emotions in the form of sadness.~   "
54903|NCT02848339|"~     Data about aspirin desensitization for patients with coronary artery disease undergoing~     percutaneous coronary intervention are sparse.~      This is a prospective, multicenter, observational study including 7 italian centers, to~     assess safety and feasibility of a standard desensitization protocol in patients with aspirin~     sensitivity undergoing coronary angiography. Patients with history of aspirin sensitivity~     undergoing coronary angiography are prospectively enrolled.All patients underwent the~     desensitization procedure with six sequential doses of aspirin (1, 5, 10, 20, 40, and 100 mg)~     administered orally at predefined intervals, with the procedure lasting 5.5 hours.All~     patients are followed for desensitization procedure success, description of reactions due to~     the desensitization procedure, and in hospital major adverse cardiac events (MACE). All~     patients are also followed-up for 12 months in order to assess their long-term risk of MACE,~     compliance with ASA therapy, and late occurrence of side reactions due to ASA sensitivity.~   "
54904|NCT02848326|"~     This study will evaluate the safety and tolerability of the following doses of AGN-241689: 10~     mg once daily (QD), 30 mg QD, 30 mg twice daily (BID), 60 mg QD, and 60 mg BID for the~     prevention of episodic migraine and will characterize the dose/response relationship.~   "
54905|NCT02848313|"~     This is an open-label, Phase 1 single-center study in approximately 40 subjects who have 1~     eye with intermediate AMD, including a high-risk drusen without geographic atrophy (GA)~     subgroup and a noncentral GA subgroup. Eligible subjects will receive 40 mg of elamipretide~     administered as a once daily 1.0 mL subcutaneous injection for 12 weeks.~   "
54906|NCT02848300|"~     This study will evaluate the skin pharmacokinetics and tolerability of bimatoprost~     Formulation A and Formulation B following 14 days of once daily topical administration in~     male participants with androgenetic alopecia (AGA).~   "
54907|NCT02848287|"~     Emergence agitation (EA) is highly prevalent in children after surgery. Risk factors for EA~     are Eye, nose and throat (ENT) surgery, preoperative anxiety, postoperative pain. There are~     several preventive strategies but none of them completely prevent EA.~      Topical application of ropivacaine can reduce post-tonsillectomy pain. Therefore, it might~     reduce the incidence of postoperative EA.~   "
54908|NCT02848274|"~     The purpose of the study is to develop a prognostic index model for the rare disease of~     mycosis fungoides and sezary syndrome. This will be done by collecting standardized clinical~     data at various institutions. The investigators hope this will enable the identification of~     low- and high-risk groups for survival in order to improve patient care and outcome.~   "
54909|NCT02848261|"~     The primary objective of this project is to examine the impact of a continuous glucose~     monitoring (CGM) intervention on health and psychological outcomes in young children with~     type 1 diabetes (T1D).~   "
54910|NCT02848248|"~     The study will examine the safety profile of SGN-CD123A. The study will test increasing doses~     of SGN-CD123A given every 3 weeks to patients.~   "
54949|NCT02847741|"~     Suicidal behavior (SB) is a public health problem. The clinical model currently admitted to~     the understanding of SB is a stress vulnerability model, but so far, all scientific works has~     no clinical application. The management of psychiatric patients, including depressed~     subjects, faces the inability to detect those with a high risk of SB. Many studies have shown~     a link between low cholesterol and SB. A study has recently proposed a total cholesterol~     threshold below which the risk of suicide could be increased. However, a prospective study is~     needed to assess the predictive nature of such an indicator.~   "
55026|NCT02846740|"~     This pilot study aims to investigate whether a treatment called cranial electric stimulation~     or CES can decrease risk factors for suicide. The specific CES device we will use is called~     Alpha-Stim®. CES will be used in addition to usual treatment (medication and group therapy).~   "
54911|NCT02848235|"~     Kenya recently adopted new treatment guidelines for pregnant women with HIV, which calls for~     all women to initiate triple-drug antiretroviral therapy (ART) at or soon after their first~     visit for antenatal care. As part of this new standard of care to prevent mother to child~     transmission of HIV (PMTCT), Kenya also established the Kenya Mentor Mother Program (KMMP) in~     2012 to provide guidance for standardizing peer education and psychosocial support services~     within the national PMTCT program. This new standard of care (life-long ART and the KMMP)~     will only yield significant improvements in preventing mother to child transmission if women~     accept the triple-drug treatment during pregnancy and adhere to visit schedules so that they~     receive uninterrupted supplies of their medications during pregnancy through at least the~     cessation of breastfeeding. The primary objectives of this study are: (1) to evaluate~     implementation of the new guidelines in Kenya under actual, real-world conditions in major~     maternal and child health clinics in the southern Rift Valley region of Kenya; and (2) to~     evaluate, also under routine program conditions, the benefits of an innovative intervention~     package designed to improve implementation of the new treatment guidelines. The intervention~     uses the existing Mentor Mothers, who already are part of the PMTCT program staff at clinics.~     At the end of each clinic visit, the Mentor Mother will review with patients their treatment~     plan and schedule their next visit. The Mentor Mother will also offer, at each encounter, to~     send a text message reminder to the patient for their next clinic visit and offer to set up~     an automatic reminder directly on the patient's cell phone. The intervention strategy was~     developed in close collaboration with local health facility and PMTCT program staff based on~     their prior and on-going experience providing PMTCT services in the region, and this strategy~     has the potential to dramatically improve PMTCT service delivery and support global goals to~     eliminate mother to child transmission.~      The study is taking place in 12 clinics in the south-rift valley region of Kenya. A total of~     360 patients will be enrolled into the study (approximately 30 at each clinic). The~     investigators are enrolling patients to receive their permission to look at information~     recorded in their medical records. All patients eligible for the study, who provide written~     consent, will be included in the study until the target number of 360 is obtained. After~     consenting, the study will have no further contact with patients. Because the study only~     reviews information in medical files that clinics already collect as part of routine care,~     risks to patients are minimal. The only possible risk is the accidental disclosure of HIV~     status, but the study is designed to minimize such a risk. There are no direct benefits to~     study participants, as the study is designed to understand existing adherence to PMTCT care~     and treatment and to improve such adherence. The study is expected to start in 2016 and end~     in 2019.~   "
54912|NCT02848222|"~     The purpose of this prospective study is to evaluate the benefits of using the Bruder Moist~     Heat Compress in contact lens wearers who report reduced comfortable wear time. This will be~     done by assessing for improvement in ocular oil gland function and comfortable contact lens~     wearing time after one month of daily warm compress application. The efficacy of the Bruder~     Moist Heat Compress applied once will be compared to twice daily application as well as~     compared to warm compress application using a wash cloth.~   "
54913|NCT02848209|"~     The purpose of this study is to examine the histological skin changes induced by different~     peeling agents (Trichloroacetic acid 25% and 40% and phenol/croton oil) in subcutaneous~     undermined facial skin flaps.~   "
54914|NCT02848196|"~     The study is designed to to assess the efficacy of ablative SBRT delivered with VMAT~     technique in oligometastatic patients affected by adrenal gland metastases.~   "
54915|NCT02848183|"~     The purpose of this study is to optimize therapy according to the known risk factors and~     treatment response in pediatric acute myeloid leukemia (AML)~   "
54916|NCT02848170|"~     Phase 3 study to examine the relation between antihypertensive effect and baseline factors~     exploratively, compared to olmesartan medoxomil in patients with essential hypertension.~   "
54917|NCT02848157|"~     Caudal block is often performed to relieve postoperative pain in pediatric urological~     surgery. Recently, pudendal block is also used in penile surgery and it has advantage because~     of less side effects such as transient weakness of low extremities, but limited to use in~     penile surgery. Local anesthesia is a single shot injection, so additional analgesic drugs is~     required when the effect of local anesthetics are disappeared. Dexmedetomidine, an alpha~     adrenergic agonist, is commonly used in pediatric sedation. It has analgesic effect and~     potentiates the effect of local anesthetics. There are many studies about the potentiation of~     the effect of local anesthetics when added to dexmedetomidine in adults, it has been limited~     in pediatrics. Recent study said that local anesthetics with dexmedetomidine had prolonged~     duration of analgesia in caudal block, also in ilioinguinal block. Thus it is expected to~     have a prolonged effect when investigators use dexmedetomidine in pediatrics as well as~     adults.~   "
54918|NCT02848144|"~     Infectious shocks are associated with high mortality rates (20-40%). Anti-inflammatory~     strategies based on the postulate that mortality related to sepsis is mainly due to an~     overwhelming pro-inflammatory immune response have failed. Some patients surviving this~     initial phase can develop immune dysfunctions because the compensatory mechanisms become~     deleterious when they persist over time. The persistence of immunosuppression at day 3 or 5~     is independently associated with more nosocomial infections and higher mortality rate. The~     clinical and laboratory evidence for sepsis induced immunosuppression have been recently~     reviewed by Hotchkiss et al. Apoptosis-induced depletion of immune effector and blood studies~     from septic patients showed decreased production of pro-inflammatory cytokines, decreased~     HLA-DR expression, increased percentage of regulatory T cells, and increased production of~     programmed cell death (PD)-1. Some small positive phase 2 trials of biomarker guided immune~     enhancing agents granulocyte-macrophage colony stimulating factor (GM-CSF) and interferon γ~     (IFN γ) have been reported.~      There are insufficient data showing that such an immunosuppression exists in children. Only~     one study performed in children with organ dysfunctions admitted to pediatric intensive care~     unit (PICU), showed that 34% of them developed immunosuppression. This study was performed on~     a heterogeneous population and immunological analyses were limited. Therefore, there is a~     crucial need of studies on septic patients with matched controls to provide more evidence~     that the same paradigm exists in children. The collaboration of laboratories with a high~     level of experience in this domain, and a clinical unit with a high potential of recruitment~     of children with severe infectious shock should allow us to perform the first prospective~     study specifically done in children with infectious shock.~      The main hypothesis is that children with severe infectious shock developed sepsis-induced~     immunosuppression as shown in adults. This will be assessed by the expression of HLA-DR on~     monocytes' surface. We make the hypothesis that children who become immunosuppressed are more~     prone to develop secondary nosocomial infectious and stayed longer in PICU and in hospital.~      Children aged from 1 month to 17 years, admitted to PICU at HFME Lyon-Bron are eligible if~     they have the criteria for severe sepsis or septic shock, defined by the Surviving Sepsis~     Campaign 2012 or those of Toxic Shock Syndrome (TSS) (definitions of CDC - Center for~     Disease Control). An information leaflet will be issued to parents and children / adolescents~     and they will be informed of their right to object to the search. Are provided as part of~     this research:~        -  Immunological measures (mHLA -DR) in three stages: in the first 48 hours, between D3/5~          and D7/9. The volume of collected blood will not exceed 2.4 ml / kg.~        -  The collection of nosocomial infections and status at D30 A control group of patients~          hospitalized for surgery without sepsis or toxic shock criteria will be recruited in the~          same hospital by ICU investigators and matched for age. Similarly controls will be given~          oral and written information and they will have the opportunity to deny inclusion. They~          will have the same exams as the first group of patients.~   "
54919|NCT02848131|"~     The study goal is to assess the effect of senescent cell clearance on senescence burden,~     physical ability or frailty, and adipose tissue-derived mesenchymal stem cell (MSC)~     functionality in patients with chronic kidney disease (CKD).~   "
54920|NCT02848118|"~     Procedure sedation of flexible bronchoscopy (FB) comforts patients undergoing FB.~     Hypoventilation during FB is a concern. The investigators investigate the feasibility of~     monitoring capnography in FB sedation.~   "
54921|NCT02848105|"~     aGVHD remains as complication in patients after allogeneic stem cell transplantation.~     Methylprednisolone at 1~2mg/kg is considered as standard first-line treatment. In recent lab~     study, we demonstrated that valproic acid (VPA) as histone deacetylase inhibitor can inhibit~     CD4+ Th1 and Th17 cells and control the aGVDH in mice model while preserve the GVL effects.~     In this study, we tested the hypothesis that adding VPA to standard dose steroid treatment~     may improve the outcome of aGVHD.~   "
54922|NCT02848092|"~     Teens with Attention-Deficit/Hyperactivity Disorder (ADHD) have high rates of negative~     driving outcomes, including motor vehicle crashes, which may be caused by visual inattention~     (i.e., looking away from the roadway to perform secondary tasks). A driving intervention that~     trains teens to reduce instances of looking away from the roadway will be tested in teens~     with ADHD.~   "
54923|NCT02848079|"~     This study will examine the safety and effectiveness of oxaliplatin in combination with~     TAS-102 (TAS-OX) for treatment of patients with metastatic colorectal cancer whose cancer has~     progressed or recurred after FOLFOX chemotherapy.~   "
54924|NCT02848066|"~     The purpose of this study is to evaluate sensitivity and specificity of newly defined tumor~     biomarker with gastric cancer pts and cancer-free healthy volunteers.~   "
54950|NCT02847728|"~     This is an observational, multicenter study in patients treated with nivolumab for the~     approved indications of melanoma and lung cancer in Australia, the EU, Switzerland, and the~     United States (US). Targeted countries in the EU for study participation include Austria,~     Belgium, France, Germany, Italy, Spain, and the United Kingdom (UK). Study objectives are to~     assess the safety experience, survival, adverse event management, and outcomes of adverse~     events associated with nivolumab in routine oncology care facilities.~   "
54957|NCT02847637|"~     This is a randomized, global, multicenter, open-label, Phase 3 clinical study in participants~     with severe hemophilia A without inhibitors against Factor VIII (FVIII) who are 12 years or~     older. The study evaluates two prophylactic emicizumab regimens versus no prophylaxis in this~     population with emphasis on efficacy, safety, and pharmacokinetics.~   "
54925|NCT02848053|"~     Objectives: This study is aimed to assess whether Tianqi Capsule interventions have a~     long-term effect on the risk of diabetes and provide evidence that early intervention by~     traditional Chinese medicine could delay the progression from impaired glucose tolerance to~     diabetes.~      Study contents: 1.420 participants were followed up for 8 years to assess the long-term~     effect of Tianqi Capsule. Phone-call followed up was applied to investigate the status of~     impaired glucose tolerance and orthoglycemic survivors until the end of REDUCES study. 2.To~     participants that determined the status of glucose metabolism, a variety of ways were used to~     find the evidence of diagnosis of glucose metabolic status, such as glycemia laboratory~     sheets from normal hospitals, medical records, the use of antidiabetic drugs or insulin~     injection, etc. 3. To participants that undiagnosed the status of glucose metabolism, oral~     glucose tolerance test, blood pressure, weight and blood biochemical analysis were performed~     to assess the state of glucose metabolism. 4. Questionnaires were given to all the~     participants to investigate their condition of treatment, diet, exercise and other lifestyle.~   "
54926|NCT02848040|"~     Bile acid malabsorption (BAM), a common cause of diarrhoea, affects 1 million people in the~     UK, but is often misdiagnosed as irritable bowel syndrome or goes unrecognised in patients~     with inflammatory bowel disease.~      The SeHCAT (seleno-tauro-homocholic acid) test is currently the only diagnostic test for BAM,~     but it is not widely available and it is also time consuming, expensive and involves exposure~     to radioactivity. Some clinicians give a course of blind or empirical treatment instead. The~     National Institute of Clinical Excellence (NICE) recognised these issues and highlighted the~     need for cheaper and safer tests to identify BAM.~      This study will assess the accuracy of a simple, convenient and inexpensive laboratory test~     for the rapid diagnosis of BAM which measures bile acids in stool. This test has the~     potential to have a broad impact on clinical practice and patient care by enabling doctors to~     identify and treat patients with BAM promptly. Results from the second phase of the study~     will allow the assessment of the benefits of monitoring the stool test to determine whether~     the bile acid changes can predict the response to treatment and dosage needed for each~     patient.~   "
54927|NCT02848027|"~     Single-center, lab blinded to include up to 400 subjects with knee osteoarthritis. Collection~     of synovial fluid from diseased knee before and after Regenexx®SD treatment will serve as the~     experimental condition, i.e. the osteoarthritic knee.~   "
54928|NCT02848014|"~     The purpose of the study is to determine whether a short psychological intervention aiming at~     optimizing expectations is able to foster positive emotions and whether an intervention~     inducing positive emotions is able improve participants' expectations. Furthermore, the~     investigators will examine whether both interventions are effective in buffering the stress~     response after an acute stressor in a healthy sample compared to a control condition.~   "
54929|NCT02848001|"~     CC-90009-AML-001 is a phase 1, open-label, dose escalation and expansion, study in subjects~     with relapsed or refractory acute myeloid leukemia~   "
54930|NCT02847988|"~     The primary aim of this proposal is to test the effectiveness of neuromuscular electrical~     stimulation (NMES) in improving functional status and muscle function in patients receiving~     prolonged mechanical ventilation.~   "
54931|NCT02847975|"~     Investigators recently showed that tadalafil restores functional sympatholysis in patients~     with Becker muscular dystrophy (BMD). If tadalafil restores functional sympatholysis in BMD~     via the NO-cyclic guanosine monophosphate pathway, then functional sympatholysis should also~     be restored by sodium nitrite— which is an indirect nitric oxide donor.~   "
54932|NCT02847962|"~     Corn-soy vitamin and mineral fortified blended foods (FBFs) are primarily used for food aid,~     although sorghum and cowpea may be suitable alternative FBF commodities. The objective of the~     Micronutrient Fortified Food Aid Pilot Project (MFFAPP) Tanzania Efficacy Study is to~     determine whether newly formulated, extruded sorghum- and cowpea-based FBFs have equal, or~     better, nutritive value and acceptance compared to a traditional corn-soy blend. The~     effectiveness of each blend will be determined in an efficacy study of Tanzanian children~     under the age of 5 that are deficient, or at risk for deficiency, in iron and vitamin A.~   "
54933|NCT02847949|"~     This is a Phase 2 multi-center, open-label study that allows subjects who derived clinical~     benefit after completing IGN002 treatment in a separate Valor study (e.g. IGN002-101) to~     continue treatment with IGN002. Subjects who completed a separate Valor-sponsored IGN002~     study, tolerated IGN002 treatment, and did not experience progressive disease (PD) are~     eligible to participate in this study.~   "
54934|NCT02847936|"~     Surgical repair of perineal lesions after delivery can be associated with infection of the~     surgery site. The aim of this study was to compare the surgical site infection with~     triclosan-coated suture (Vicryl Plus) versus coated suture (Vicryl) in the episiotomy after~     delivery.~   "
54935|NCT02847923|"~     The aim of this study is evaluate a software developed for alternative communication designed~     for people with speech difficulties. The software was executed by 30 volunteers using mobile~     devices that helped to play the scenarios simulated of communication situations.~   "
54936|NCT02847910|"~     The purpose of this study is to explore the clinical effect of disposable tissue suction tube~     set for induced abortion and make comparison with traditional metal instruments．~   "
54937|NCT02847897|"~     The study is intended to assess the safety and efficacy of CO2 AcuPulse laser treatment in~     patients with vaginal prolapse. Eligible subjects will receive 3 treatment sessions, 4 weeks~     apart and 3 Follow Up visits, at 1, 3, and 6 months following the last treatment.~   "
54951|NCT02847715|"~     Improvements in cancer treatment have led to an increasing number of patients being cured or~     in remission, but they are followed up to detect recurrence, manage persistent symptoms and~     late treatment effects. With growing survivors, traditional hospital follow-up is not~     sustainable. New models of follow-up care are needed. This research project aims to develop~     and establish the feasibility of introducing a new electronic care pathway/system for remote~     monitoring ovarian cancer patients in remission. The project includes a development phase,~     followed by a before-and-after study to explore the feasibility of a new pathway/system for~     remote monitoring.~   "
54952|NCT02847702|"~     The purpose of this study is to evaluate the analgesic efficacy, safety, and tolerability of~     VM902A twice daily compared to placebo in subjects with moderate to severe chronic pain due~     to OA of the knee.~   "
55027|NCT02846727|"~     The purpose of this study is to determine if fluorescence angiography can detect occult shock~     (hypoperfusion).~   "
54938|NCT02847884|"~     Crohn's disease (CD) is a lifelong condition of inflammation in the bowel. CD can affect any~     part of the gastrointestinal tract from mouth to anus. Symptoms can include: tiredness,~     stomach pain, diarrhea (which may be bloody if the disease is severe), fever, weight loss,~     skin rashes, arthritis and inflammation of the eye.~      Infliximab-IFX (Remicade®) is a medication that is used to treat CD in adults and children.~     In adults it has been shown that the amount of this drug a person has in their blood can show~     how well it is working for them. Health Canada has approved Infliximab -IFX for the treatment~     of CD in children 9 and older. In Canada, doctors may prescribe Inflixmab to younger children~     when other therapies do not resolve their disease symptoms. This is called off-label use of~     Infliximab.~      IFX levels in the body and consequently its efficacy can be influenced by many biological~     characteristics within the patient's body. In about 17% of those treated with IFX, the~     patient's immune response against IFX may lead to a three to fivefold increased risk of loss~     of response. This immune response to the medication often occurs when drug levels are~     undetectable in the body. Thus it is in order to achieve best results with this treatment,~     physicians need to be able to adjust dosing specific to each patient. A recent study has~     shown that 29% of children have an undetectable IFX level at the 4th medication infusion. Up~     to 40% of patients receiving scheduled IFX have undetectable drug level prior to their next~     infusion.~      In order to minimize the loss of response, we hope to conduct an observational cohort study~     of pediatric patients treated with IFX.~      This open label, cohort study aims to:~        1. Determine the pharmacokinetics of IFX in children with CD and the factors that affect~          IFX levels during the first three loading infusions~        2. Obtain data to create a model that can guide and adjust the IFX dose and frequency to~          achieve optimal trough level between 5 and 10 ug /ml at 14 weeks.~   "
54939|NCT02847871|"~     Loss of mobility is predictive of a loss of autonomy and is often the first sign of~     functional decline. Loss of mobility is also associated with poor perceived quality of life,~     depressive symptoms, high risk of adverse events such as falls and fractures, to an increased~     risk to input in institution and mortality's increase.~      Consequences and frequency of loss of mobility make essential its identification, evaluation~     and the practice of preventive measures in primary care.~      The implementation of effective interventions in primary care to prevent or delay the loss of~     mobility is a public health priority.~      PRISME-3P program aims to develop and evaluate a dedicated care pathway, in primary care,~     based on a personalized multimodal intervention: screening, support combining physician,~     teaching exercises by a specialized Monitor in Adapted Physical Activities (MAPA) and~     nutritional counseling.~   "
54940|NCT02847858|"~     Health -E-You is an interactive, individually tailored computer application (App) that was~     developed to educate adolescent girls about contraceptive methods and assist them in~     selecting a contraceptive method that meets their individual needs. The goal is to reduce~     disparities in unintended pregnancy rates among Hispanic adolescent females.~      The App was designed in close collaboration with clinicians and Hispanic adolescents.~     Health-E You was designed to be used in conjunction with a clinical encounter to prime both~     the patient and provider prior to the face-to-face visit to facilitate the discussion and~     provision of appropriate contraception. It is founded on key principles of Social Cognitive~     Theory.~      Through an interactive approach, Health-E-You assesses the users' sexual health risks,~     knowledge and contraceptive use history and preferences to facilitate a sense of agency and~     self-efficacy around selecting an effective contraceptive method. First, the user selects~     their preferred language (English or Spanish) and according to the selected language, the App~     provides a brief description of the module and consents the user to participate. It then~     assesses sexual health knowledge using an interactive truth vs. myth game. Correct answers to~     the truth vs. myth statements are then presented to the user as short, easy-to-read~     explanations. Next, the App assesses the user's individual contraceptive needs and~     preferences. The user is also screened for possible medical contraindications to~     contraceptive methods. Based on the user's input, the App provides individually tailored~     messaging and recommendations for contraceptive methods according to the user's own timeline~     for childbearing and their lifestyle preferences, past experiences and needs. The~     recommendations are presented on a visual continuum of effective contraceptive options based~     on desired duration of action and efficacy. Users then have the option to learn more about~     the recommended method(s) and they also have the option to learn more about any of the~     contraceptive options. Evidence-based contraceptive information is presented in a~     user-friendly format that includes YouTube style videos. Users can select to view brief video~     vignettes that feature clinicians who provide additional information about the method of~     interest and/or videos of diverse young women who discuss their experiences with each of the~     contraceptive methods. At the end of the App, adolescents are asked to select the method (s)~     they are most interested in using. They are also encouraged to use condoms to protect against~     sexually transmitted infections (STIs) and provided information about emergency~     contraception. Users can review a summary of a key information gathered from the App and are~     offered the opportunity to share that information with their clinician so that the clinician~     can better support the adolescent in selecting and using an effective and appropriate~     contraceptive method.~      The objective of this study is to evaluate the effectiveness of Health-E You on its ability~     to address disparities in contraceptive knowledge, access and utilization among Hispanic~     adolescents. The long term goal is to reduce the incidence of unprotected sexual intercourse~     (and associated unintended pregnancies and STIs) over time. A total of 14 School-Based Health~     Centers (SBHCs) affiliated with the Los Angeles Unified School District, will be randomized,~     with equal chance, to use the Health-E You App or to provide usual care (without the App). A~     total of 1400 Hispanic adolescents will be selected to participate in the study (700 at~     intervention clinics and 700 at the control clinics). The investigators hypothesize that~     adolescents who use the Health-E You App will have greater sexual health knowledge and will~     be more likely to use effective contraceptive than adolescent who do not use the App. The~     investigators will also evaluate the effectiveness of the App on its ability to improve the~     effectiveness and efficiency of the health visit. Participants will be asked to complete~     follow-up surveys immediately following the clinical encounter and at three and six months~     after the clinical encounter.~      The ultimate goal of this study is address health disparities in the use of effective~     contraceptives and ultimately reduce the incidence of unintended pregnancies and STIs among~     at-risk Hispanic adolescent girls.~   "
54941|NCT02847845|"~     The purpose of this study is to verify the efficacy of taking red ginseng for chronic fatigue~     patient.~   "
54942|NCT02847832|"~     The ability of different methods to discriminate between benign and malignant adnexal masses~     has been compared in a meta-analysis showing that the IOTA Simple Rules and the IOTA logistic~     regression model LR2 were superior to RMI and to all other methods for predicting malignancy~     in an adnexal mass included in the meta-analysis. However, a fair comparison of methods~     requires them to be applied on the same tumor population.~      The general objective of this study is to prospectively validate the Simple Rules, ADNEX, the~     Simple Rules risk model, LR2, and RMI on a large multicenter dataset to allow direct~     comparison of these tools.~      IOTA7 is an international multicenter prospective observational study including different~     types of ultrasound centers and examiners with different levels of ultrasound experience. In~     total, about 1700 adnexal masses with histological outcome will be included in IOTA 7.~   "
54943|NCT02847819|"~     Total of 100 patients are included in this is a prospective observational study to evaluate~     the role of airway ultrasound (USG) in assessing vocal cord mobility in patients undergoing~     thyroid surgery. patients will be scanned preoperatively by airway ultrasound which will be~     compared to post operative ultrasound scans.~   "
54944|NCT02847806|"~     Sexual steroids administered to supra-physiological doses are likely to change the~     carbohydrate and lipid metabolism.~      Investigators propose to study in 12 hypogonadal men hypogonadotropic or hypergonadotropic~     treated with aromatase inhibitor, the respective effects of estradiol, testosterone or both~     steroids administered in a cross-over Latin squares plan on insulin sensitivity measured by~     the reference method of the hyperinsulinemic euglycemic clamp.~   "
54945|NCT02847793|"~     Cognitive biases are a hallmark of depression but there is scarce research on whether these~     biases can be directly modified by using specific cognitive training techniques.~      The aim of this study will be targeting and modifying specifically relevant attention biases~     in participants with subclinical depression using eye-tracking methodologies. This innovative~     approach has been proposed as a promising future line of intervention in Attention Bias~     Modification procedures (Koster & Hoorelbeke, 2015).~      Recent findings suggest that depression is characterized by a double attentional bias (Duque~     & Vazquez, 2015), More specifically, depressed individuals have difficulties both to~     disengage from negative materials (e.g., sad faces) and to engage with positive materials~     (e.g., happy faces). Thus, training procedures to change attentional biases should target~     these two separate components.~   "
54946|NCT02847780|"~     This study is planned to compare C-Mac video-laryngoscope and airway ultrasound as two novel~     techniques (causing least discomfort to the patients) for the detection of impaired~     vocal-cord movement after thyroid surgery.~   "
54947|NCT02847767|"~     The high dose per fraction (>10Gy/fraction) used in Stereotactic Ablative Body Radiotherapy~     (SABR) has been shown to be more effective at local tumor control than treatments employing~     more conventional dose fractions. The mechanisms for this are currently under debate. One~     possible mechanism for this increased effectiveness is that high dose/fraction causes~     significant vascular damage to the tumor. This study hopes to measure vascular integrity pre~     and post SABR treatment using kinetic models obtained from dynamic contrast enhanced CT.~   "
54948|NCT02847754|"~     Standard indications for palliative radiation of bony metastases include pain, spinal cord~     compression, and impending pathologic fractures.~      Palliative radiation therapy serves to reduce pain, improve quality of life, and avoid~     complications. Tailored training of the paravertebral musculature may support Radiation~     therapy and improve above named factors. DISPO-2 was designed to investigate the impact of~     tailored physical exercise in patients with unstable vertebral metastases as compared to~     manual therapy (massage etc.). The trial includes patients with painful unstable bony~     metastases, patients with spinal cord compression or impending pathological fractures are~     excluded. The investigations are carried out in a prospective randomized controlled phase-II~     parallel group design.~   "
54953|NCT02847689|"~     The purpose of this study is to examine whether playing recordings of a mother's voice to her~     infant while in the hospital nursery is an effective treatment for promoting healthy brain~     and language development in infants born preterm.~   "
82976|NCT02480868|"~     The purpose of this investigation is to assess safety and performance of ARTEBONE Bone Void~     Filler in the single arthrodesis procedure.~   "
54959|NCT02847611|"~     The main objective of this work is to validate the dynamometer LABIN in comparison with the~     technique of gold-standard reference JAMAR, in a healthy population.~      The infringement of the prehension is frequent and impacts on the social and professional~     quality of life of the patients. There are numerous instruments measuring the strength of~     prehension. The JAMAR is a mechanical, hydraulic dynamometer, exploring in kilograms the~     maximal strength of the prehension. It is at present Gold Standard for the measure of the~     strength of prehension. There is for the moment no electronic known instrument exploring the~     endurance of the strength of prehension during an effort of tightening. This parameter would~     indeed be interesting for the exploration in geriatrics and in the neuromuscular pathologies.~      This study justifies itself by the fact that the dynamometer LABIN should allow the~     evaluation of the muscular endurance of the strength of hand as complement of the peak of~     strength~   "
54960|NCT02847598|"~     The primary purpose of the study is to evaluate the efficacy of BIIB059 in reducing disease~     activity in participants with systemic lupus erythematosus (SLE) with active cutaneous~     manifestations and joint involvement (Part A), and in participants with active cutaneous~     lupus erythematosus (CLE) (Subacute cutaneous lupus erythematosus (SCLE) or chronic CLE,~     including discoid lupus erythematosus (DLE)) with or without systemic manifestations (Part~     B). The secondary objective is to evaluate additional efficacy parameters of BIIB059 in~     reducing SLE/CLE disease activity, pharmacokinetic parameters, safety and tolerability of~     BIIB059 (Parts A and B).~   "
54961|NCT02847585|"~     Pediatric dilated cardiomyopathy (PDCM) is the most common form fond in children.~     Water-soluble coenzyme Q10 (ubiquinol) is better absorbed than lipid-soluble coenzyme Q10~     (ubiquinone) and is directly involved in the antioxidant cycle. Because coenzyme Q10 has~     shown significant health benefits in adult patients with cardiovascular disease, it is worth~     studying water-soluble coenzyme Q10 supplements to evaluate their potential role as~     complementary therapy for PDCM. The purpose of this study is to explore the potential role of~     water-soluble ubiquinol in complementary therapy for pediatric cardiomyopathy. We will~     recruit 25 children with primary PDCM (age 0-20 y) and examine the relationship between~     coenzyme Q10 level and cardiac function (left ventricular fractional shortening and ejection~     fraction, and B-type natriuretic peptide), oxidative stress (malondialdehyde), antioxidant~     enzymes activity (catalase, glutathione peroxide, and superoxide dismutase), and inflammation~     (high sensitivity C-reactive protein and interleukin-6) in PMC after 6 months water-soluble~     ubiquinol supplementation (10 mg/kg BW/d, by oral drops). In addition, we will assess the~     quality of life of PDCM patients by questionnaire. Through this study, we expect to~     demonstrate that water-soluble coenzyme Q10 will be a complementary therapy for PDCM, and~     will improve cardiac function, increase antioxidant capacity, slow deterioration of cardiac~     function and reduce inflammation, and further reduce the rate of heart transplantation and~     increase quality of life in PDCM.~   "
54962|NCT02847572|"~     This will be a single center, non comparison clinical trial. Fifty study patients will have~     the Symfony IOL implanted in their dominant eye and a +3,25D Tecnis Multifocal in their~     non-dominant eye. The investigators will be evaluated vision at distance, intermediate and~     near as well as assessing patient satisfaction and spectacle independence.~   "
54963|NCT02847559|"~     The purpose of this research study is to determine the effects bevacizumab (the study drug)~     combined with Optune (the study device) tumor treatment field therapy has on meningiomas.~     Bevacizumab is considered investigational because the US Food and Drug Administration (FDA)~     has not approved its use for the treatment of meningiomas. The study drug is a medication~     that blocks the growth of new blood vessels. It is thought that the study drug may interfere~     with the growth of new blood vessels and therefore might stop tumor growth, and possibly~     shrink the tumor by keeping it from receiving nutrients and oxygen supplied by the blood~     vessels. Optune is also considered investigational because the US FDA has not approved its~     use for the treatment of meningiomas. Optune is a device that the patient will wear and use~     for at least 18 hours of each day. It delivers alternating electrical current to the~     patient's brain tumor and by doing so interrupts a process called mitosis. Mitosis needs to~     occur in order for cell division to occur and allows tumors to grow. By slowing this process,~     we hypothesize that meningioma growth may also be slowed.~   "
54964|NCT02847546|"~     The primary objective of this study is to collect data to confirm the performance and safety~     of the True™ Flow Valvuloplasty Perfusion Catheter during dilatation of the aortic valve in~     the preparation for Transcatheter Aortic Valve Implantation (TAVI).~   "
54965|NCT02847533|"~     This study focuses on blood inflammatory markers (pro-inflammatory cytokines,~     anti-inflammatory cytokines, monocytes costimulation molecules) in patients with resistant~     unipolar depression in comparison with non-resistant unipolar depressed patients.~   "
54966|NCT02847520|"~     If the addiction to games of chance and gambling is a disease of increasing knowledge, the~     emergence of poker rout evaluation procedures, prevention and treatment usually offered to~     players in need. In the case of poker, which unlike other games has a real part to address~     and which damages are expressed differently, the evaluation can not be done identically to~     other games. This problem has often been emphasized in the literature, in particular the lack~     of specific tools for the identification of poker gambling problems. Thus, the fact of~     developing a specific evaluation tool could allow poker to take into account the specificity~     of poker among other games. This would be part of the evaluation complement batteries~     currently available to players in general by offering a specific tool, and secondly to allow~     the assessment of the aspects of the problems often absent for other games . The goal here is~     to develop and validate a specific tool detection of problem gambling in the particular~     context of poker.~   "
54967|NCT02847507|"~     Study of seroprevalence of hepatitis E among HIV positive patient in Basque country, France~     in 2016.~   "
54968|NCT02847494|"~     This is an emergency department based randomized trial in which we compare two different~     treatment for migraine headache. The goal is to decrease the number of headache days during~     the week after ED discharge.~   "
54969|NCT02847481|"~     This is a randomized pilot study to characterize engraftment of a donor's microflora onto~     patients with Irritable Bowel Syndrome with diarrhea following fecal microbiota~     transplantation.~   "
56966|NCT02821364|"~     PIPT Trial (Philadelphia Immediate Transport in Penetrating Trauma Trial) A prospective~     randomized clinical trial comparing pre-hospital procedures to immediate transportation in~     patients with penetrating injury and shock.~   "
54970|NCT02847468|"~     Hepatocellular carcinoma (HCC) is the third cause of death by cancer. For patients with~     inoperable advanced HCC, systematic therapy with Sorafenib, a multikinase inhibitor that has~     both antiangiogenic and antiproliferative effect, is the only therapeutic with proven~     survival benefits. However, the efficacy of Sorafenib remains inconstant with a media overall~     survival of 10,7 months and a disease control rate only 35 to 43%; moreover, the overall~     incidence of treatment-related adverse event is 80%. Thus, it appears essential to find an~     early and accurate way to determine which patients are best responding to therapy in order to~     avoid the toxicity and cost of ineffective therapy.~      Positron Emission Tomography (PET) with 18F-Fluorodeoxyglucose (FDG) has shown limited~     performance in the setting of HCC because of lack of sensitivity, in particular for~     well-differentiated tumours. However FDG uptake is related to proliferation rate and is an~     efficient marker survival following liver transplantation and selective internal radiation~     therapy. Moreover, the addition of a dynamic first-pass acquisition to the standard static~     scan provides better characterization of the tumour by adding information on tumour~     perfusion.~      FCH which reflects lipids metabolism and specifically choline kinase activity, has shown~     promising results for detection of HCC when compared with FDG alone. Moreover, choline~     activity is related to a kinase pathway in mammalian cells, which is specifically inhibited~     by Sorafenib. However FCH uptake remains inconstant in HCC, and is related to tumour~     differentiation, by opposition to FDG. Therefore, several studies have suggested that~     combined evaluation of tumour glucose and lipid metabolism could play a complementary role~     for the evaluation of HCC in the setting of detection, staging and to predict recurrence~     following surgical resection. Thus, the investigator hypothesize that the combination of FDG~     and FCH may be the most accurate imaging evaluation of HCC.~      Thus the aim of the present study is to determine the predictive performance of survival of~     lipid and glucose metabolism and perfusion changes during Sorafenib therapy in patients with~     advanced HCC.~   "
54971|NCT02847455|"~     Patients with endoscopically diagnosed active duodenal ulcer disease were enrolled in a~     randomized, double-blind, parallel and dose-ranging trial. They were randomly assigned into~     three groups to be treated for up to four weeks and be seen at week 1, 2 and 4: three of~     ilaprazole, 5, 10 mg/day, and one of Rabeprazole 10 mg/day as positive control. The primary~     endpoint was the ulcer healing rate at week 4. Healing of ulcer was determined by its~     resolution from active to scarring stage. Symptoms relief was evaluated as secondary end~     points by using a graded score. Safety and tolerability were evaluated on basis of clinical~     assessments.~   "
54972|NCT02847442|"~     The purpose of this study is to evaluate the change in subject's condition according to the~     Investigator's Global Assessment of Change after three months of treatment with 50 mg~     opicapone once daily in a heterogeneous patient population reflecting daily clinical~     practice.~   "
54973|NCT02847429|"~     This is a multicenter, randomized, double-blinded, placebo-controlled, trial of oral~     crenolanib versus oral placebo in combination with best supportive care in subjects with~     advanced or metastatic GIST with a D842V mutation in the PDGFRA gene. Approximately 120~     subjects will be randomized in a 2:1 ratio to receive either crenolanib 100 mg or matching~     placebo orally (PO) 3 times daily (TID) in combination with best supportive care.~   "
54974|NCT02847416|"~     the aim of this study are to explore the characteristics of mean airway pressure, oscillatory~     amplitude and power spectral density (PSD) of oscillatory airway pressure that generate by~     various loaded and flow rate during expiration and inspiration in healthy subjects and to~     explore the best loaded and flow rate for airway secretion clearance using the BreatheMAX®~     device~   "
54975|NCT02847403|"~     The overall objective of the study is to assess the potential effects of the long-acting~     GLP-1 analogue exenatide in preventing/slowing the progression of cognitive dysfunction and~     related biomarkers in dysglycemic/prediabetic patients with mild cognitive impairment (MCI).~   "
54976|NCT02847390|"~     The investigators will develop a novel diabetes prescriber superuser educational program~     focused on inpatient diabetes management for physicians, based on their input. The~     investigators will then examine the impact of the diabetes prescriber superuser program and~     an analogous diabetes nurse superuser program that is already developed on glycemic control~     and other outcomes in hospitalized patients with diabetes.~   "
54977|NCT02847377|"~     The development of biomarkers will lead the dynamic of personalized medicine and fill the~     unsatisfied needs in oncology for prediction of therapeutic response.~      Molecular imaging enables non invasive quantification of biomarkers. The development of~     molecular imaging biomarkers is closely related to the development of therapeutic molecules.~     Among the potential targets, kinases offer a lot of advantages: (i) they play a central role~     in cellular regulation, (ii) numerous kinase-specific small molecule libraries exist in~     biotech and pharma industry, (iii) several kinase-targeted therapies are used in clinic~     (imatinib, sorafenib, sunitinib…) with application across a variety of therapeutic~     indications. Among the imaging technologies, the Positron Emission Tomography (PET) is the~     most sensitive and dedicated to evaluate small molecules. However few radiotracers are~     available and their specificity limits their clinical use. The IMAkinib® approach is an~     innovative method proposed to develop new PET radiotracers adapted to current medical and~     economical challenges.~      The epidermal growth factor receptor (EGFR) is an established target for the treatment of~     advanced non-small cell lung cancer (NSCLC). The EGFR tyrosine kinase inhibitors (TKIs)~     Gefitinib (Iressa®), erlotinib (Tarceva®) and afatinib (Giotrif®) have already been approved~     for treatment of NSCLC harboring EGFR activating mutations (L858R or del exon 19).~     Unfortunately the majority of patients will develop a resistance to the TKI in the long term~     (6-12 months). If the mechanism of resistance is not yet fully characterized, most patients~     (50%) will acquire an additional T790M mutation of EGFR. TKI PET-imaging can provide a tool~     to determine and predict responsiveness to EGFR TKI in vivo. That is why, the investigators~     have selected and radiolabeled (18-Fluor) a compound targeting specifically EGFR mutated~     ([18F]-ODS2004436) which was further evaluated in a preclinical imaging study to determine~     the feasibility of TKI-PET. The investigators proved in vivo that [18F]-ODS2004436 a compound~     is a good candidate to evaluate the EGFR activity in human lung tumours using PET imaging.~   "
54978|NCT02847364|"~     The purpose of this study is to determine whether chewing gum post-operatively decreases the~     time to first flatus or defecation in patients undergoing spine surgery as a indirect~     indicator of post-operative ileus.~   "
54979|NCT02847351|"~     The study aimed to investigate whether an Arabinoxylan-enriched crackers consumption for 4~     weeks in overweight and obese patients without diabetes mellitus have specific healthy~     effects on glycemic control (reduction of homeostatic model assessment -HOMA index-).~     Furthermore, study evaluated the effects of Arabinoxylan on insulin, lipid and Ghrelin.~   "
54999|NCT02847091|"~     The objective of this study is to assess the reduction in insulin dose from baseline at Week~     24 while keeping the blood glucose levels controlled (maintaining HbA1c values) when~     ipragliflozin is administered once daily for 24 weeks in patients with type 2 diabetes~     mellitus receiving insulin therapy.~   "
55000|NCT02847078|"~     The purpose of the study is to investigate the effects of smart phone app on the secondary~     prevention for patients with coronary heart disease post percutaneous coronary intervention.~   "
55028|NCT02846714|"~     The overall purpose of this study is to test the feasibility, acceptability, and preliminary~     efficacy of a family-focused behavioral intervention (FLARE, which stands for Family~     Lifestyle Actions and Risk Education) that aims to improve adherence to melanoma preventive~     behaviors among children at elevated risk for the disease.~   "
54980|NCT02847338|"~     High blood pressure (Hypertension) is extremely common and is a major cause of heart disease,~     kidney disease and stroke. One in three of the UK (United Kingdom) population will require~     treatment for hypertension at some point in their lives. A healthy lifestyle alone is often~     not enough to control blood pressure, and drug treatment is usually required. Although a wide~     variety of drugs are available to treat hypertension, choosing the right kind of tablet or~     combination of tablets for individual patients is a problem, and therefore many people have~     poor blood pressure control.~      Hypertension treatment within the UK is currently selected according to age and self-defined~     ethnicity (SDE). There are limitations to this approach which include wide variability in the~     response to hypertension drug classes between people. There is also uncertainty about~     selecting hypertension drugs for ethnic minorities other than those of African/Caribbean~     ancestry, for example, South Asians because of a lack of information from trials. In the AIM~     HY-INFORM study the investigators are looking to recruit equal number of black/caribbean,~     south asian and white european participants to be able to compare differences in hypertension~     treatments and ethnicity.~      The primary objective of this study is to determine if the response to antihypertensive drugs~     differs by self defined ethnicity.~   "
54981|NCT02847325|"~     AC0058TA is a small molecule compound that potently, selectively and irreversibly inhibits~     Bruton's tyrosine kinase (BTK) phosphorylation and downstream signals, resulting in~     inhibition of inflammatory cytokine production in monocytes and inhibition of lymphocyte~     activation (predominantly B-cell activation) in the preclinical studies. The nonclinical~     program has demonstrated that AC0058TA has the potential to interfere with signaling~     functions mediated by tyrosine kinases and may be useful for controlling excessive or~     aberrant T- and B-cell activation in autoimmune diseases.~      As an investigational targeted therapy for RA and SLE, AC0058TA is expected to address the~     unmet need of this patient population, for whom there are currently no effected therapies and~     there is a great unmet medical need, AC0058TA may inhibit the key pathway which involves the~     disease process.~   "
54982|NCT02847312|"~     In this proposed human trial, the investigators aim to establish whether 4 weeks of daily~     consumption of beta-glucan matched meals providing either a high dose or a moderate dose of~     oat avenanthramides and phenolic acids leads to dose-dependent chronic improvements in~     markers of CVD risk and gut health relative to an energy matched control intervention in~     healthy adults with above average blood pressure.~   "
54983|NCT02847299|"~     The purpose of the study is to compare the the efficacy and tolerance of 2 cough assistance~     techniques requiring no equipment other than the volumetric fan. The two methods are~     air-stacking and hyperinflation .~      The study is a Cross-over, monocentric and open label study~   "
54984|NCT02847286|"~     A Study to assess the drug-drug interaction potential, between Dapivirine Vaginal Ring-004,~     containing 25 MG of Dapivirine.~   "
54985|NCT02847273|"~     Near-infrared spectroscopy (NIRS) is a continuous and non-invasive technology that measures~     regional tissue oxygen saturation (rSO2). Whatever the anatomical site of measurement, a~     normal value of rSO2 would suggest a good adequacy between oxygen supply and consumption at~     the regional level. Beside the trend ability of previous 2 or 3-wavelength devices, a new~     4-wavelength generation of NIRS monitors which could reliably assess real-time absolute~     values of rSO2 is now available. The investigators aimed to compare peripheral absolute rSO2~     values given by the 4-wavelength EQUANOX device 7600 (Nonin Medical, Plymouth, Mn) and the~     new O3 device (Masimo, Irvine, CA) during conventional cardiac surgery.~   "
54986|NCT02847260|"~     The purpose of the study is to evaluate the safety and tolerability of a rapid dose titration~     regimen of subcutaneous Remodulin® therapy in patients with PAH.~   "
54987|NCT02847247|"~     Purpose: The purpose of this study is to classify volunteers as endotoxin-responders or~     non-responders following inhalation of 20,000 EU Clinical Center Reference Endotoxin (CCRE).~     Endotoxin is a commonly encountered bioaerosol and component of indoor and outdoor air~     pollution. For reasons that remain unclear, some individuals appear to be more susceptible to~     the inflammatory effects of inhaled endotoxin than are others, possibly owing to single~     nucleotide polymorphisms in the Toll-like receptor 4 (TLR4) gene that influence TLR4~     signaling and function. These susceptible individuals represent a population of particular~     interest for further mechanistic studies of the effects of endotoxin and for therapeutic~     trials. Susceptibility to inhaled endotoxin will be determined by measuring change in~     peripheral blood neutrophil counts, a biomarker of systemic inflammation, following inhaled~     CCRE. In our previous work, the investigators have found that inhalation of 20,000 EU CCRE is~     well tolerated and induces measurable increase in neutrophil content of peripheral blood in~     susceptible individuals. Our hope is that this CCRE inhalation protocol can be employed to~     screen large populations for susceptibility to the inflammatory effect of inhaled endotoxin.~   "
54988|NCT02847234|"~     Cervical necrotizing fasciitis (CNF) is a rare but severe complication of pharyngeal or~     dental infections. The infection can rapidly descend into the mediastinum and lead to a~     life-threatening prognosis. Treatment consists of a multidisciplinary approach in intensive~     care with radiologist and with early and repeated surgical debridement. Anti-inflammatory~     drugs have been incriminated by authors in the development of necrotizing fasciitis.~     Recently, a single-center study demonstrated that pharyngeal source of CNF and oral~     glucocorticoid intake before admission was associated with the occurrence of mediastinitis.~      The aim of the study is to assess the incidence and factors associated with CNF~     complications, in particular mediastinitis. Secondary outcome is to describe patient~     characteristics, medical and surgical management.~      Methods: A retrospective, observational, non-interventional multicentre study is conducted in~     nine intensive care units in France from January 2005 to December 2016.~   "
54989|NCT02847221|"~     Successful weaning from mechanical ventilation in ICU patients depends on patient ability to~     breathe spontaneously and on cough efficiency. Previous studies found that cough peak flow~     (CPF) at 60 L/min threshold predicted extubation failure. These studies measured CPF using a~     dedicated flow-meter that required patient disconnection from the ventilator, limiting the~     generalizability of this procedure. This study aimed to predict extubation outcome in a~     consecutive series of patients by measuring CPF from the ventilator flow-meter. CPF~     measurements were done by freezing ventilator screen and scrolling the cursor to the maximal~     value of CPF during expiration and Tidal Volume (TV) in preceding inspiration.~      The objective was to assess the performance of CPF to predict early extubation outcome.~   "
54990|NCT02847208|"~     Little is known about gynaecological follow-up and cervical screening in Cystic Fibrosis~     (CF). Only few studies have described contraceptive practices in cohorts of CF women.~      The investigators did a cross-sectional study in a cohort of 155 CF women attending the Lyon~     adult centre. Women attending the CF adult centre in 2014 completed a written questionnaire~     about their contraceptive choices, frequency of gynaecological follow-up and cervical~     screening. Other clinical data were collected from the CF adult centre registry.~      One hundred and twenty women (100%) answered the questionnaire, among whom two were~     post-menopausal (46 and 59 years of age), and five were pregnant.~      Seventy-four per cent of the women declared they had undergone gynaecological followup (89%~     of the women with transplantation), and only 55% reported having at least one previous Pap~     smear test. Among the transplanted patients, only 58% had had a Papsmear test, despite~     immunosuppressive treatment. The overall rate of contraception was only 64% and in diabetic~     women, it was 61%. Among contraception users; 65% used oral contraception, predominantly~     combined estrogen-progestagen (47%); among diabetic patients, 26% used progestin-only~     contraception. Intrauterine device accounted for 10% of patients using contraception, and~     tubal ligation only 4%.~      This study is limited by its cross-sectional design. Despite an internal validation of the~     questionnaire showing an almost perfect agreement, the risk of recall bias has to be taken~     into account.~      This study of practices highlights the importance of improved information regarding~     sexuality, fertility and reproductive health in young women with CF. A regular gynaecological~     follow-up and cervical screening is mandatory in this population.~      Better gynaecological care and contraceptive advice would help to avoid unplanned~     pregnancies, and optimize contraceptive selection in relationship to specific clinical~     conditions.~   "
54991|NCT02847195|"~     Assess the depth of sedation and analgesia in pediatric intensive care is critical to the~     management of intubated patients under mechanical ventilation. The responsiveness of the~     pupil is changed by the sedation and analgesia. Measuring the pupil diameter is proposed in~     anesthesia and intensive care to assess the quality of analgesia in adult population.~     Visually measuring the diameter of the pupil remains very imprecise, but this measure can be~     accurately and quickly performed thanks to portable devices called Pupillometers. Some~     devices including Algiscan® device (IdMed ) can measure in addition to the pupil diameter,~     the variation of pupil diameter, the latency of the pupillary reflex and the maximum speed of~     contraction. Pupillometry was tested in adult ICU patients, during painful and painless~     procedures [1]. In this study, pupillometry was more sensitive for detecting pain compared to~     the change in heart rate or bispectral index. The objective of this work is to perform~     measurements of pupil diameter during painful procedures (e.g. tracheal aspiration) in PICU.~     In parallel we will continue using the Comfort B-scale (has been validated for assessment of~     pain in children admitted to a pediatric intensive care unit [2-5] and compare the results of~     both types of assessment pain.~   "
54992|NCT02847182|"~     This is a single site, prospective, randomized, double-blind study of a single intravenous~     autologous or allogeneic, unrelated cord blood (CB) infusion in children ages 2-7 years with~     Autism Spectrum Disorder (ASD). Participants will be randomly assigned to Sequence A,~     consisting of a single infusion of CB cells at baseline followed 6 months later by a single~     infusion of placebo, or Sequence B, consisting of an infusion of placebo at baseline followed~     6 months later by an infusion of CB cells. All participants will ultimately be treated with~     CB cells at some point during the study. Participants with an available qualified autologous~     CB unit will receive autologous cells, and those without a suitable autologous CB unit~     available will receive cells from a ≥4/6 HLA-matched, ABO-matched allogeneic, unrelated donor~     CB unit from the Carolinas Cord Blood Bank. All infusions will be double-blinded. The primary~     outcomes will be assessed 6 months after the initial infusion in the sequence. Additional~     testing for secondary exploratory analyses will be performed at 12 months. Duration of study~     participation will be 12 months from the time of baseline infusion.~   "
54993|NCT02847169|"~     The aim of this prospective study is to evaluate the clinical performance of filcon IV1 toric~     and ocufilcon D toric contact lenses after 1 week of wear in each pair.~   "
54994|NCT02847156|"~     Respiratory Viral Infections (RVI) are particularly frequent in young children. Old data~     mention the deleterious role of some viruses such as the Respiratory Syncytial Virus in young~     children with cystic fibrosis (CF). However, recent epidemiological data on RVI in CF~     children are rare and the impact of most frequent viruses such as human rhinoviruses is~     usually not correctly evaluated.~      The aim of this study is to assess the frequency of lower and upper RVI during a 1 year~     follow-up in CF infants and to evaluate the impact of RVI at a clinical, microbiological and~     therapeutic level.~      Our hypothesis is that frequent and/or clinically severe RVIs have the worst impact in the~     short term and without any particular link with a specific virus as previously described.~   "
54995|NCT02847143|"~     The study aims to characterize the cerebral activation modifications related to nasal~     oxytocin administration during vizualisation of distress images in population of healthy~     people with different attachement styles.~   "
54996|NCT02847130|"~     This research study seeks to identify, understand, and overcome barriers to the use of~     clinical practice guidelines by pediatric oncology healthcare providers The treatments for~     childhood cancers are intense and result in a high rate of symptoms which require support by~     healthcare providers. By reviewing patients' medical chart records, meeting in focus groups~     and in one-on-one interviews, healthcare providers may improve how clinical practice~     guidelines are used to support children undergoing cancer treatment.~   "
54997|NCT02847117|"~     Mastiha is a natural product from the tree Pistacia lentiscus var. Chia (Anacardiaceae)~     growing exclusively in the Southern part of Chios Island. It is the natural resinous exudate~     produced after longitudinal incisions made at close intervals from the base of the trunk up~     to the thicker branches of the tree. U.S. Food and Drug Administration has classified Mastiha~     as GRAS. Previous research demonstrates Mastiha's safety, as well as anti-inflammatory,~     antimicrobial and antioxidant properties. In addition, the European Medicine Agency has~     recently recognized Mastiha as a natural medicine and classified it to the category of~     traditional herbal medicines in diarrhea problems, mild dyspeptic disorders, skin~     inflammation and healing (EMA/HMPC/46758/2015).~      However, the bioavailability of its microconstituents in human biological samples is still~     undetermined. To this end, the current study aims to investigate the whether Mastiha's~     compounds are bioavailable in healthy adults. Twenty apparently healthy men, aged 20-40 years~     old, will be enrolled based on certain inclusion and exclusion criteria. The staff of the~     study will provide detailed information regarding the aims, the methods, anticipated benefits~     and potential hazards of the study and all patients will receive the Patient Information~     Leaflet (PIL). Ample time (48 hours) will be provided in order to decide whether they want to~     participate in the protocol. Each patient agreeing to participate will sign an Informed~     Consent document and the staff will explain to patients that they are under no obligation to~     enter the trial and that they can withdraw at any time during the trial, without having to~     give a reason. A copy of the signed Informed Consent will be given to the participant.~      After enrollment, the volunteers will undergo a medical and dietary assessment and their~     health status will be evaluated through a complete blood count. Then, they will follow a~     low-phytochemical diet for five days, meaning that they will exclude fruits, vegetables,~     legumes, coffee, tea, alcoholic beverages and chocolate. On the day of the experiment and~     after overnight fasting, the volunteers will consume 10g of natural Mastiha and blood samples~     will be obtained on timepoints 0h, 30min, 1h, 2h, 4h, 6h and 24h after Mastiha intake. Until~     timepoint 6h, they will be allowed to consume only water. Urine samples will also be~     collected on timepoints 0h, 4h, 8h and 24h.~      After collection, the phenolic and terpenoid content or metabolites of Mastiha will be~     identified in plasma samples applying LC-HRMS. Additionally, the metabolomic profile will be~     assessed in plasma samples with LC-HRMS and in urine samples with NMR-based metabolomics.~     Oxidative stress will be evaluated through the CuSO4 technique and oxidised LDL levels in~     serum samples, as well as F-2 isoprostanes in urine samples.~   "
54998|NCT02847104|"~     Intensive care unit (ICU) patients commonly display hyperglycemia, even without previously~     known diabetes. It was demonstrated that hyperglycemia was associated with increased hospital~     mortality in various medical and surgical ICU situations. However, discrepant results from~     recent randomized, clinical trials of tight blood glucose control in ICUs have not allowed~     conclusions regarding whether there is a causal link between hyperglycemia and ICU mortality.~     In addition to the mean blood glucose level, glucose variability has recently been emphasized~     as an independent predictor of ICU and hospital mortality. This concept has been described in~     a wide variety of medical, surgical and trauma ICU patients. In all of these settings,~     glycemic variability was measured with various indices but was steadily associated with ICU~     and/or hospital mortality in non-diabetic ICU patients. Conversely, glycemic variability was~     either weakly or not associated with mortality in ICU patients with previously known~     diabetes. Notably, all of these data have been observational, and interventional trials~     remain lacking to assess the impact of glycemic variability reduction on ICU mortality and~     thus to demonstrate causality. However, glycemic variability was considered sufficiently~     important to be mentioned in recent international guidelines for the management of~     hyperglycemia in critically ill patients. In these publications, experts from the American~     College of Critical Care Medicine emphasized that glycemia should be maintained at less than~     9.9 mmol/L in ICU patients while avoiding hypoglycemia and minimizing glycemic variability.~     To achieve these goals, computer-based insulin infusion protocols have demonstrated their~     superiority to paper-based protocols. Glucose concentrations, variation per unit of time~     between the last and current glucose measurements, insulin dosage, and carbohydrate intake~     were the main input variables used in these different computerized algorithms. However, such~     protocols are not widely available because commercial systems have licensing fees and~     academic protocols do not always go beyond the pilot phase.~      To address this issue, the investigators adapted a previously validated, paper-based, dynamic~     protocol (DP) to an actual recommended glycemic target range. Our aim was to assess the~     efficacy, safety, feasibility and acceptance by nurses of this dynamic insulin protocol,~     compared to a paper-based, sliding scale static protocol (SP).~   "
55001|NCT02847065|"~     In the US and Europe, bacteremia are ranked the 7th leading cause of death from all causes.~     E. coli is one of the main microorganism involved, responsible for 30% to 45% of bacteremia.~     In Europe, bacteremia E. coli, including BLSE phenotype, have a strong impact on public~     health, causing increased mortality, particularly in the elderly, and an increase in the~     average hospital stay. However, few studies have specifically concerned with the criteria~     associated with mortality of elderly patients with BLSE E. coli bacteremia. Finally,~     improving epidemiological knowledge of the elderly patients with bacteremia due to BLSE E.~     coli has importance in terms of public health and is a prerequisite to the development of~     preventive strategies and to improve the short-term prognosis.~   "
55002|NCT02847052|"~     IL-22 is an IL-10 family cytokine that plays major actions to increase intestinal epithelial~     barrier function and regeneration during experimental colitis. IL-22 binding protein is a~     small, soluble, and secreted protein potently inhibiting IL-22 actions through preventing the~     binding with IL-22 Recepteur. This study aims at characterizing how IL-22 binding protein is~     regulated in Inflammatory bowel disease to better understand the way IL-22 acts on epithelial~     cells during flares of the disease.~   "
55003|NCT02847039|"~     The research project aims to try to answer the many questions raised by the identification of~     new early repolarization syndrome. The questions are varied with both taking optimal clinical~     management of patients, the frequency and significance of this anomaly in the population on~     the electrophysiological and molecular basis responsible for this electrocardiographic~     abnormality.~      To try to answer these many questions, the approach will be twofold: clinical and genetic.~        -  Establishment of a clinical database containing information of patients who have been~          identified as carriers of the anomaly based on the initial clinical presentation in~          order to determine their prognoses.~        -  Physiological approach will be based on a molecular approach to identify genetic~          abnormalities may be involved in this syndrome.~        -  200 asymptomatic patients and an unlimited number of patients who presented syncope or~          aborted sudden death will be included.~      A blood sample (15 ml) will be performed at inclusion.~   "
55004|NCT02847026|"~     This is an open-label phase IV, randomized controlled trial of inactivated poliovirus vaccine~     (IPV) and rotavirus vaccines. This trial will assess immunogenicity of a booster dose of~     fractional IPV (fIPV) in comparison with a full dose of IPV when given after varying IPV and~     fIPV schedules. Differences in immunogenicity of the varying schedules of IPV and fIPV will~     also be examined. Concomitantly, immunogenicity to two different rotavirus vaccines will be~     evaluated.~   "
55005|NCT02847013|"~     This present investigation aims to determine whether a transversus abdominous plane(TAP)~     block, utilizing liposomal bupivacaine (Exparel), at the conclusion of a cesarean section~     decreases post-operative pain. The hypothesis is that performance of the TAP block with~     liposomal bupivacaine will decrease post-operative narcotic use.~   "
55006|NCT02847000|"~     Patients with pancreatic cancer which has stopped responding to one or more chemotherapy~     drugs are asked to take part in this study. The study hopes to find out whether decitabine,~     the drug being studied, will have an effect on pancreatic cancer. The decitabine is being~     given at a lower dose than its approved use. It is also being given with another drug,~     tetrahydrouridine (THU), to improve the exposure of your pancreatic cancer cells to~     decitabine.~      The purpose of this study is to determine if the drug combination of decitabine and~     tetrahydrouridine can recognize a certain DNA target in your cancer. All cells have DNA~     within them, and tumor cells have abnormal DNA.~   "
55007|NCT02846987|"~     The purpose of this study is to test any good and bad effects of the study drug called~     Abemaciclib. Abemaciclib could shrink your cancer but it could also cause side effects.~     Researchers hope to learn if the study drug will delay the growth of the cancer or shrink the~     cancer by at least one quarter compared to its present size. Abemaciclib is not FDA approved~     and has not been tested in liposarcoma, but it has shrunk tumors in patients with breast~     cancer, lymphoma, and lung cancer.~   "
55008|NCT02846974|"~     Pulse oximetry is a vital tool in the rapid and non-invasive assessment of emergency~     patients, providing a continuous estimate of hemoglobin saturation in arterial blood.~     Unfortunately, the costs of these devices are prohibitive and reduce availability in smaller~     centres and poor countries, putting millions of patients in danger of easily treatable and~     preventable conditions. With current rapid prototyping technologies such as 3D printing, it~     is possible to create a very inexpensive pulse oximeter that meets or exceeds the gold~     standard. The goal of this study is to develop, validate and certify a pulse oximeter that~     measures hemoglobin, carboxyhemoglobin and methemoglobin. This pulse oximeter will be~     certified with Health Canada, and then released under the Open Hardware License (OHL), such~     that hospitals and ministries of health in rural and impoverished communities in Canada and~     internationally would have easy access to these devices.~   "
55009|NCT02846961|"~     The purpose of this study is to evaluate the development of anti-drug antibody to biosimilar~     CT-P13 and to assess the change of drug concentration for 1 year in patients with moderately~     to severe inflammatory bowel disease.~   "
55010|NCT02846948|"~     The aim of the study is to identify the diagnostic value of the focused assessed~     echocardiography protocol (FATE - Holm et al 2012) for patients undergoing urgent abdominal~     surgery and having signs of sepsis. The extended cardiac monitoring may affect patient's~     management during perioperative period. The investigators expect that the incidence of~     hemodynamic instability will be reduced and the outcomes of the patients will be improved.~   "
55011|NCT02846935|"~     The purpose of this study is to evaluate how well the study drug works and safety of oral~     decitabine in patients with refractory or relapsed lymphoid malignancies. The decitabine is~     being given at a lower dose than used for its approved use. It is also being given with~     another drug, tetrahydrouridine (THU), to improve the exposure of lymphoma cells to~     decitabine.~   "
55012|NCT02846922|"~     To evaluate the efficacy of catheter ablation and rate control in heart failure patients with~     atrial fibrillation.~   "
55024|NCT02846766|"~     This is a two center, open label, non-randomized Phase II study of lenvatinib in adult~     subjects with recurrent or refractory advanced cancers with aberration(s) in FGF/FGFR~     signaling. Treatment will consist of daily oral administration of Lenvatinib in 28-day~     cycles.~   "
55025|NCT02846753|"~     A prospective, non-randomized multi-center clinical investigation of the Venus P-Valve™ for~     the treatment of pulmonary regurgitation with or without stenosis in patient with native~     outflow tracts.~   "
55013|NCT02846909|"~     Pregnancy loss in the second trimester is not uncommon. About 2-3% of pregnancies will be~     lost in the second trimester, which is much lower than in the first trimester. Once a~     pregnancy reaches 20 weeks gestation, less than 0.5% will end in a fetal demise.~      Congenital fetal abnormalities and maternal anatomic factors as immunologic factors,~     infection, and thrombophilia should be considered; however, a reason and its result~     connection may be difficult to be established.~      Cervical incompetence means that the cervix is weak and unable to remain closed during the~     pregnancy. While cerclage may provide a degree of support to a 'weak' cervix, its role in~     maintaining the cervical length and the endocervical mucus plug as a mechanical barrier to~     ascending infection may be more important.~      Cervical cerclage is performed usually in women with a history of mid-trimester abortion or~     spontaneous preterm birth due to cervical 'incompetence', with the aim of preventing~     recurrent loss.~      Cerclage is a commonly performed as a prophylactic intervention used by most obstetricians~     despite the absence of a well-defined population for whom there is clear evidence of benefit.~     Furthermore, there is little consensus on the optimal cerclage technique and timing and type~     of suture placement.~      The Progesterone is known to have an inhibitory action on uterine contractility and is~     thought to play a main role in the maintenance of pregnancy until term. Progesterone is also~     able to modify the ultrastructural organisation of the myometrium by inhibiting the gap~     junctions, and preventing muscular contraction.~      Different routes of administration of progesterone have been described in the literature.~     These include weekly intramuscular injections from 16 to 20 weeks through to 36 weeks and~     daily vaginal progesterone suppositories from 24 weeks to 34 weeks of gestation.~      A recently published Cochrane review further confirmed the beneficial effects of progesterone~     in infant health following administration in women considered to be at increased risk of~     preterm birth due either to past history of preterm birth or when a short cervix was~     identified on ultrasound.~      However; most of these published studies have been conducted to test the effect of~     progestational agents for the prevention of preterm labor not miscarriage.~      Doppler ultrasonography is use to evaluate blood flow. In the field of perinatology, Doppler~     ultrasonography has been used to assess fetal well-being, especially in intra-uterine growth~     retardation and fetal anemia, and it plays an important role in managing of these conditions~   "
55014|NCT02846896|"~     PBC is a rare, autoimmune, cholestatic liver disease with genetic and environmental~     pathogenetic factors. Data about epidemiology of PBC in Switzerland are completely lacking.~     Epidemiology can be a powerful tool in yielding important clues as to burden and etiology of~     diseases. In addition, the investigators study will be the first one carried out in the~     country on PBC, and therefore will raise disease awareness and create a network.~   "
55015|NCT02846883|"~     This project is to determine the safety and explore the effectiveness of allogeneic (not~     cells of the participant but those of another human) mesenchymal stromal cells (MSCs) in~     decreasing inflammation and possible enlargement of the participants' abdominal aortic~     aneurysm. Participants will be selected as a possible subject because of an abdominal aortic~     aneurysm discovered on the ultrasound or computed tomographic (CT) scan requested by the~     participants' doctor.~      The purpose of this study is to collect information that will be used to determine if MSCs~     can be used to decrease inflammation and possibly slow down enlargement of the participants'~     aneurysm. The investigators will also be collecting blood samples to study special~     inflammatory cells that cause aneurysms as well as asking participants to have a PET~     (positron emission tomography) scan that can measure inflammation directly in the~     participants' aneurysm.~   "
55016|NCT02846870|"~     This randomized clinical trial studies how well visually enhanced education works in~     improving prostate cancer and treatment knowledge in patients with prostate cancer that has~     not spread to other places in the body. Visually enhanced education includes pictures,~     drawings, and photos, may help doctors better convey information about radiation and prostate~     cancer to patients.~   "
55017|NCT02846857|"~     Closed-loop strategy is composed of three components: glucose sensor to read glucose levels,~     insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required~     insulin dosages based on the sensor's readings. A dual-hormone closed loop strategy regulates~     glucose levels through the infusion of two hormones: insulin and glucagon.~      The objective of this study is to compare, in a randomized multicenter trial, the~     effectiveness of single-hormone closed-loop, dual-hormone closed-loop, and sensor-augmented~     pump therapy with low-glucose suspend in regulating day-and-night glucose levels in~     outpatient settings for 15 weeks in adolescents and adults.~      The investigators hypothesize that dual-hormone closed-loop will reduce time spent in~     hypoglycemia compared to single-hormone closed-loop, which in turn will be more effective~     than sensor-augmented pump therapy with low-glucose suspend.~   "
55018|NCT02846844|"~     In a Phase-III Study Patients With Chemotherapy-induced Polyneuropathy (NCI CTC Grade 2/3)~     Are Randomized for an Integrated Program (IP) Including Massage, Mobilization in Posture and~     Transport Layers, Physical Exercises (Standard) or With Whole-body Vibration (WBV) Platform~     Training (Experimental).~   "
55019|NCT02846831|"~     Closed-loop strategy is composed of three components: glucose sensor to read glucose levels,~     insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required~     insulin dosages based on the sensor's readings.~      The objective of this study is to compare the effectiveness of single-hormone closed-loop and~     sensor-augmented pump therapy in regulating day-and-night glucose levels in adults with T1D~     for 12 days in outpatient settings.~      The investigators hypothesize that dual-hormone closed-loop will increase the percentage of~     time of glucose levels spent in the target range in adults compared to single-hormone~     closed-loop, which in turn will be more effective than sensor-augmented pump therapy.~   "
55020|NCT02846818|"~     Impaired cerebral function remains an important complication of cardiopulmonary bypass (CPB)~     during cardiac surgery. The aim of the present study is to investigate whether the lactate to~     pyruvate (LP) ratio obtained by microdialysis (MD) of the cerebral venous outflow reflects a~     derangement of global cerebral energy state during cardiopulmonary bypass.~   "
55021|NCT02846805|"~     The purpose of this study is to investigate to what extent IOs improve the functionality of~     edentulous patients and changes in quality of life and overall patient satisfaction following~     treatment with IOs.~   "
55022|NCT02846792|"~     This phase I/II trial studies the side effects and best dose of plinabulin when given~     together with nivolumab and to see how well they work in treating patients with stage IIIB-IV~     non-small cell lung cancer that has come back or spread to other places in the body.~     Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to~     grow and spread. Drugs used in chemotherapy, such as plinabulin, work in different ways to~     stop the growth of tumor cells, either by killing the cells, by stopping them from dividing,~     or by stopping them from spreading. Giving nivolumab and plinabulin together may work better~     at treating patients with non-small cell lung cancer.~   "
55023|NCT02846779|"~     The purpose of this study is to evaluate three pharmacist-outreach strategies for improving~     adherence to insulin among individuals with diabetes. The three approaches are~     equivalently-priced but vary by degree of targeting and intervention intensity.~   "
55108|NCT02845674|"~     This is a safety extension enrolling subjects participating in Study OTX-101-2016-001~   "
55029|NCT02846701|"~     The primary purpose of this protocol is to evaluate the lowest plasma concentration (ie~     before the daily taking dose of duloxetine) in patients relieved of at least 30% of their~     neuropathic pain with duloxetine treatment.~      The secondary purpose of this protocol is to determine plasmatic concentration peak (ie 6~     hours after taking duloxetine) in patients relieved of at least 30% of their neuropathic pain~     with duloxetine treatment.~      Others secondary purposes are to evaluate the intensity of neuropathic pain, to assess the~     degree of pain relief and to evaluate the sensation of the global improvement experienced by~     the patient.~   "
55030|NCT02846688|"~     To analyze the genome pattern in human gastric Intestinal Metaplasia Mucosa and duodenal~     Mucosa.~   "
55031|NCT02846675|"~     it's a self-control, double blind study of autologous adipose-derived stromal vascular~     fraction (SVF) to treat 50 osteoarthritic knees of grade II or III (K-L scale) under~     IRB-approved protocol in a feasibility and safety study.~   "
55032|NCT02846662|"~     Background: Depression is a usual comorbid event associated to chronic diseases, such as~     hypertension and diabetes, constituting an important public health problem, with negative~     consequences for patients' quality of life and self-care, as well as for compliance with~     medical treatment. In low and middle income countries depression is often unrecognized and~     untreated, and there is a lack of human resources to treat depression and other mental~     problems in these health care systems.~      Aim: The present study aims to test a 6 week low-intensity psychological intervention~     (CONEMO) delivered via an applicative for smartphones for people with depressive symptoms and~     co-morbid diabetes and/or hypertension recruited in primary health care units, in São Paulo~     (Brazil).~   "
55033|NCT02846649|"~     The objective is to determine feasibility and acceptability of a text message (SMS)-based~     relapse prevention intervention as measured through: (1) study retention and SMS query~     completion rates and (2) participant ratings of PIER1 interest, perceived efficacy, and ease~     of use. Methods: A mixed methods study of adult (age >=18) ED patients who seek treatment for~     opioids and have evidence of dependence based on Rapid Opioid Dependence Screen (RODS) score~     of >3 and are being discharged to outpatient (community) resources. All participants receive~     standard of care in the ED, complete a baseline web survey, are asked to text with us for at~     least 7 days (up to a max of 28 days) and are asked to complete a follow-up phone call~     between day 8 and 14. Investigators expect preliminary findings to support a relapse~     prevention intervention delivered through SMS. Based on feedback from this mixed methods~     study, investigators plan to test a refined SMS program in a randomized trial.~   "
55034|NCT02846636|"~     The main objective of this study is to evaluate the 10 year performances of Mpact cup in~     total hip arthroplasty.~   "
55035|NCT02846623|"~     The goal of this clinical research study is to learn if atezolizumab and obinutuzumab (either~     with or without ibrutinib) can help control CLL. The safety of this drug combination will~     also be studied.~   "
55036|NCT02846610|"~     The German Network for acute pain management and Regional Anesthesia (NRA) is a multi-center,~     non-interventional registry and benchmark project, assessing and analysing clinical and~     patient-reported procedural and outcome data of systemic analgesia and regional anesthesia~     hosted by the German Society of Anesthesia and Intensive Care Medicine (DGAI) and~     professional Society German Anesthetists (BDA)~   "
55037|NCT02846597|"~     The appropriate pressure and duration needed for sustained lung inflation in preterm infants~     at risk of respiratory distress syndrome have not been well evaluated. We aim for evaluating~     two different pressures, 20 and 15 cm H2O, for two different duration, 10 and 20 seconds,~     during the application of sustained lung inflation in the resuscitation of preterm infants~     with respiratory distress in the delivery room.~   "
55038|NCT02846584|"~     The main purpose of this study is to explore the sequential therapeutic effect and evaluate~     the safety of anti-CD19 or anti-CD20 CAR-T cells briging HSCT in the treatment of~     relapse/refractory B cell malignancies.~   "
55039|NCT02846571|"~     The treatment in this trial consists of intraocular islet transplantation. A single dose of~     1000 - 2000 Islet Equivalents (IEQ)/kg recipient body weight (BW) will be infused into the~     anterior chamber of the eye through a self-sealing incision of the peripheral cornea. The~     procedure is projected to take approximately 20-30 minutes. Subject will remain flat on their~     back for 45-60 minutes after islet infusion to maximize adhesion of the islets to the iris.~   "
55040|NCT02846558|"~     This is a pragmatic, single-blinded randomized trial of improving adherence to dietary~     interventions in patients with MS who are receiving monthly natalizumab infusions.~   "
55041|NCT02846545|"~     The primary purpose of this study is to determine if golimumab can preserve beta-cell~     function in children and young adults with newly diagnosed Type 1 Diabetes (T1D).~   "
55042|NCT02846532|"~     The Purpose of this study is to characterize the single and multiple-dose pharmacokinetic~     (PK) and pharmacokinetic/pharmacodynamic (PK/ PD) profiles after oral rivaroxaban therapy~     administered to pediatric participants 2 to 8 years of age with single ventricle physiology~     who have completed the Fontan procedure within 4 months prior to enrollment (Part A) and to~     evaluate the safety and efficacy of rivaroxaban, administered twice daily (exposure matched~     to rivaroxaban 10 milligram [mg] once daily in adults) compared to acetylsalicylic acid~     (ASA), given once daily (approximately 5 milligram per kilogram [mg/kg]) for~     thromboprophylaxis in pediatric participants 2 to 8 years of age with single ventricle~     physiology who have completed the Fontan procedure within 4 months prior to enrollment.~   "
55043|NCT02846519|"~     The purpose of this study is to evaluate the pharmacokinetics of intranasally administered~     esketamine in healthy Han Chinese, Korean, Japanese, and Caucasian participants and to~     evaluate the effects of rifampin on the pharmacokinetics of intranasally administered~     esketamine in healthy Caucasian participants.~   "
55044|NCT02846506|"~     The purpose of this study is to evaluate bioequivalence of the metformin component of the~     Fixed Dose Combination (FDC) tablet compared with the metformin Extended Release (XR) tablet~     co-administered with canagliflozin in healthy fed and fasted participants.~   "
55045|NCT02846493|"~     This prospective, randomized, controlled clinical trial will evaluate the effect and security~     of dexamethasone prevention for Patients of Ovarian Hyperstimulation Syndrome.~   "
56967|NCT02821351|"~     The primary objective of this study is to establish the safety and performance effectiveness~     of the DiamondTemp System for the treatment of drug refractory, recurrent, symptomatic~     paroxysmal atrial fibrillation (PAF).~   "
55046|NCT02846480|"~     To find out the effectiveness of physical therapy associated with the surgical treatment over~     the simptoms and quality of life in III and IV grades of pelvic organ prolapse, patients will~     be randomly assigned to one of these groups: experimental group: pre-surgical and~     post-surgical physical therapy + behavioral education + surgical therapy. Control group:~     surgical treatment + behavioral education.~      In both groups several physical therapy assessments will be undertaken: 1st before surgery;~     2nd immediately after surgery; and after 6 weeks, 3th, 6th, 12th and 24th months~     post-surgery.~   "
55047|NCT02846467|"~     The aim of this study is to evaluate the comprehension of the Informed consent with the~     Standard Verbal Communication (SVC) versus Portable Video Media (PVM).~   "
55048|NCT02846454|"~     This proposed randomized, double blinded 12 week crossover human feeding study aims to~     investigate the effects of consuming a composite drink of inulin and arabinoxylan on satiety~     by measuring appetite biomarkers such as subjective satiety, energy/food intake and changes~     in the human gut microbiota in healthy weight males (22 to 24.9kg/m2)~   "
55049|NCT02846441|"~     Post-hepatectomy liver failure is one of the most feared complications by hepatic surgeons.~     When size of the future liver remnant (FLR) is regarded to be not sufficient to sustain~     post-hepatectomy liver function, techniques as preoperative portal vein embolization or~     two-stage hepatectomy/associating liver partition and portal vein ligation (ALPPS) can be~     performed. ALPPS induces rapid and extensive hypertrophy by portal vein ligation and in situ~     liver splitting. To date, feasibility of the second stage of ALPPS has been assessed only on~     the basis of standardized future liver remnant or future liver remnant on body weight.~     However, decrease of liver function between stages, measured by means of laboratory~     parameters, has been demonstrated to be associated with higher 90-day mortality, regardless~     of FLR volume. In other words, this volumetric increase may not reflect the increase of liver~     function.~   "
55050|NCT02846428|"~     This study will evaluate the efficacy and safety of treatment with oral capecitabine or~     intravenous (IV) 5-fluorouracil (5-FU), in combination with epirubicin and cyclophosphamide,~     prior to surgery in participants with breast cancer. The participants will receive 4 cycles~     of neoadjuvant Capecitabine + Epirubicin + Cyclophosphamide (CEX) or 5-FU + Epirubicin +~     Cyclophosphamide (FEC 100) chemotherapy during first treatment period (Period 1, Days 1-85).~     After 4-6 weeks of the fourth cycle of neoadjuvant chemotherapy (Day 120 +/- 7 days), breast~     surgery with regional lymph node dissection will be performed, followed within a maximum of 6~     weeks by the second treatment period (Period 2, Days 1 to 85) when participants in both study~     arms will receive 4 cycles of adjuvant docetaxel 100 milligrams per meter square (mg/m^2) by~     IV infusion on Day 1 of each 21-day cycle. Upon completion of the second treatment period,~     participants will enter the post-treatment follow-up period which will last for 5 years from~     the initial date of participant randomization. During this period participants will be~     evaluated once a year on the anniversary date of randomization.~   "
55051|NCT02846415|"~     This study intends to use Play Intervention for Dementia (PID) to promote cognitive functions~     of people with early to moderate dementia.~      This is a cluster randomized controlled trial aims to recruit 38 participants from two study~     sites. Participants will be randomly allocated into intervention or wait-list controlled~     groups. Both groups will receive the same content of PID programme at different time. The PID~     consists of 12 weekly sessions. Each session lasts for 45-75 minutes. The PID will be~     facilitated by a play specialist, trained elderly volunteers, and centre staffs. Cognitive~     functions will be evaluated with Montreal Cognitive Assessment, Fuld Object Memory Evaluation~     and Modified Verbal Fluency Test, conducted by a trained research assistant blinded to group~     allocation. Centre staffs (not involved in the PID) will be interviewed. Every alternate~     session will be video-taped for understanding the experience of the participants in the PID~     programme.~   "
55052|NCT02846402|"~     HSPOT is a cluster-randomized trial designed to determine whether HIV self-tests are~     acceptable and improve HIV testing rates and HIV status knowledge among female sex workers in~     Kampala, Uganda. This study will determine whether directly giving participants an HIV~     self-test or giving them a coupon to collect a test at a drug store or clinic improves~     outcomes compared to standard of care.~   "
55053|NCT02846389|"~     Like other cancer treatments, radiation therapy can make people feel fatigued, or tired. The~     investigators think that moderate exercise, done 15 minutes at a time, can reduce the~     fatigue. This study is designed to gather more information, so that in the future, doctors~     can recommend whether patients should engage in exercise during a radiation treatment course.~   "
55054|NCT02846376|"~     The purpose of the study is to determine the safety and benefit of nivolumab, ipilimumab or~     the combination of nivolumab with ipilimumab given after bone marrow transplant for patients~     with acute myelogenous leukemia and myelodysplastic syndrome.~   "
55055|NCT02846363|"~     Acute stroke management represents a true medical emergency that requires prompt diagnosis~     and urgent treatment. In a previous exhaustive cohort study conducted in the Rhône region,~     France (AVC69) the investigators observed that only a small percentage of patients could~     access to thrombolysis in time. In this cohort of 1306 patients treated in one of the~     emergency department of the Rhone region for a suspected stroke, 84% of patients reached~     hospital through an emergency department instead of going directly to a stroke unit. Among~     those patients, only 8% were finally thrombolysed, because of extended management times.. Our~     hypothesis was that public awareness campaign designed to improve public's knowledge and~     skills would consequently reduce prehospital time and favour call to prehospital emergency~     medical services (EMS).~      The investigators will conduct an awareness campaign aimed at the general population, using~     different communication media, the content will be developed based on the results of a~     qualitative study with focus groups (Quali-AVC), and using a diffusion plan established with~     communications professionals. To assess the effects of this campaign, a comparative~     quasi-experimental before-after study will be conducted. A control region where no awareness~     stroke program has been set up has been selected, data will be collected in the two regions.~     The assessment of the impact of the campaign will focus on the comparison of the evolution of~     indicators between these two regions. Three assessment time will be provided: before starting~     the program, at 3 months and at the end of the program.~   "
55056|NCT02846350|"~     This study proposes to assess the impact of a provider-based intervention to enhance~     re-engagement and improve retention, adherence, persistence and viral load among challenging~     patients in Argentina~   "
55057|NCT02846337|"~     Type 2 cardio renal syndrome is defined by the occurrence or the exacerbation of a kidney~     failure induced by a chronic heart failure. Sodium overload is one of the main causes leading~     to the occurrence or the exacerbation of this syndrome. Some patients have a massive sodium~     retention on which medications are not effective enough. These patients have no further~     therapeutic options because of the refractory congestion and a 3-months mortality rate around~     15%, frequent rehospitalization (3-months rehospitalization rate at 71%) and an excessively~     impaired quality of life.~      For those refractory heart failure with cardio renal syndrome, nephrology departments resort~     to non-medication sodium extraction (hemodialysis, peritoneal dialysis, isolated~     ultrafiltration). Between 2002 and 2008, 927 French patients would have start dialysis in~     this situation. In 2013, 174 patients start dialysis in 97 dialysis centers. French National~     Authority of Health recently published new Good Practice Guidance thereupon, strengthened by~     the increasing number of publications and the widespread use of this technique. There is~     therefore a consensus among professionals about the benefits of such a technique in those~     indications. However, bibliographical data are not strong enough to support a strong level of~     evidence. None of foresight strategies have been compared to others in a proper randomized~     controlled trial, and there is no clue about any suspected superiority from one strategy to~     another.~      So far, the investigators propound invasive, expensive and not validated techniques to~     patients with functional and vital prognosis altered. The investigators think it's essential~     to prove the efficacy of such an approach. They wish to quantify those techniques impact on~     rehospitalization, with a consideration for the potential survival impact.~      It seems unethical to evaluate separated techniques, taking in account that patients with~     severe heart failure will switch from one technique to another among their care. It is~     therefore crucial to validate benefits from an invasive procedure (hemodialysis, peritoneal~     dialysis, isolated ultrafiltration) compared to a medication-restricted care.~   "
55058|NCT02846324|"~     This study is a randomized, double-blind, placebo-controlled trial in which eligible IPF~     subjects will be randomized to receive GBT440 or Placebo orally daily.~   "
55059|NCT02846311|"~     The rapid and accurate detection of influenza virus in respiratory specimens is required for~     optimal management of patients with acute respiratory infections. Because of the variability~     of the symptoms and the numerous other causes of influenza-like illness, the diagnosis of~     influenza cannot be made on the basis of clinical criteria alone. Thus, rapid influenza~     diagnostic tests have been developed such as the Alere i Influenza A&B isothermal nucleic~     acid assay. Investigators prospectively evaluated the performance of the Alere i Influenza~     A&B assay in comparison with the routine Xpert Flu/RSV assay.~   "
55060|NCT02846298|"~     Since the discovery of streptomycin in 1944, aminoglycosides retain a remarkable bactericidal~     activity vis-à-vis including aerobic gram-negative bacilli. Thus, their synergistic effect~     with beta-lactams and their rapid bactericidal on many make unavoidable pathogens and make it~     a cornerstone of the treatment of patients with severe sepsis or state of septic shock.~      This is antibiotics exclusively parenteral administration. Their effectiveness is~     concentration-dependent and are administered by 30-minute infusion. Tolerance of venous is~     usually excellent. Their potential nephrotoxicity or cochleovestibular toxicity requires~     accurate monitoring of antibiotic residuals.~      Moreover the fact that the effectiveness of the aminoglycosides is concentration dependent,~     the rate at the peak is decisive. A first sub-therapeutic dose leads to adaptively resistant~     bacteria compared to the aminoglycoside and therefore an increase of Minimal Inhibitory~     Concentrations (MIC). Many studies have been conducted in patients hospitalized in intensive~     care, highlighting underdoses in aminoglycosides when the prescribed dosages consistent with~     those used in non reanimated patients. Dr Moore showed in 89 ICU patients with bacteremia~     gram-negative bacilli, the relationship between the clinical course and obtaining whether~     therapeutic levels during the first administration of aminoglycosides. Thus, mortality in~     patients whose antibiotic concentrations to peak were subtherapeutic, amounted to 20.9%~     against 2.4% when concentrations were within the therapeutic range. In the context or an~     initial peak in the PK / PD ( Pharmacokinetic / Pharmacodynamic) objectives namely Cmax / MIC~     ≥ 8-10 desirable, individualized therapeutic drug monitoring and identification of factors~     that may cause a concentration of antibiotic at sub-therapeutic peak seems necessary , in~     patients for the majority an increased volume of distribution.~      In addition to the β-lactams and glycopeptides, due to the increased volume of distribution~     in critically ill patients in sepsis, evaluation of serum 24 hours after starting treatment~     to check that the PK / PD goals for these molecules is achieved.~   "
55061|NCT02846285|"~     The various causes of bleeding Proctological are well known to gastroenterologists in~     clinical practice but their proportions have not, to our knowledge, been dedicated~     epidemiological studies. Investigators wanted to evaluate this data as part of a specialized~     consultation. Investigators have prospectively collected the causes of gastrointestinal~     bleeding down the patients seen two of us in specialized proctology center. A clinical~     examination including an inspection, palpation and feel, and a anoscopy (when possible) were~     made during the consultation. Local levies referred (s) histological and / or infection were~     also carried out if necessary. When she had not been made, a colonic exploration was offered~     to all patients over 45 years and / or when indicated by the pathological context. When there~     were several possible causes, the clinician holding one that seemed to be the main. Patients~     consulting within four months postoperatively a proctology action were not included. The~     study period extended from September 2013 to July 2014 inclusive. The collection of anonymous~     data.~   "
55062|NCT02846272|"~     To determine the utility of diffusion tensor magnetic resonance imaging in the preoperative~     workup of children with intractable epilepsy referred for surgery.~   "
55063|NCT02846259|"~     The first purpose of this study is to find out the clinical benefit and risk of oral aspirin~     for unruptured intracranial aneurysm (small than 7mm) combined with cerebral ischemia in~     patients in the real world.~      The second purpose of this study is to get the prediction model of aneurysm's rupture in~     patients who has unruptured intracranial aneurysm (small than 7mm) combined with cerebral~     ischemia , and find out who is suitable for oral aspirin.~   "
55064|NCT02846246|"~     Current home care service are to a large extent task oriented with a limited focus on care~     recipient's involvement. Furthermore, studies have shown that low care recipients'~     involvement might decrease older people's quality of life. Person-centred care focusing on~     involvement has improved the quality of life and the satisfaction with care for older people~     in health care and nursing homes but there is a lack of knowledge about the effects and~     meaning of a person-centred interventions in aged care at home. Present study describes the~     evaluation of a person-centred and health-promoting intervention.~   "
55065|NCT02846233|"~     In traditional step-up approach, the patients with poorly-controlled type 2 diabetes are~     instructed to take up to 4 insulin injections daily or multiple daily injections (MDI) as the~     most advanced therapy. However, a significant number of these patients continue to have poor~     diabetes control. The most common reason is the noncompliance with multiple injections and~     the patient's reluctance to accept insulin-induced weight gain. More recently, the algorithm~     in diabetes management has significantly changed to accommodate the newer generation of~     medications. Addition of the diabetes medications, that can induce weight loss such as oral~     Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors and once-weekly glucagon-like peptide~     (GLP)-1 receptor agonists (GLP1 RA) injection, to a basal insulin is now recommended before~     the patient is advanced to MDI. This approach works very well in most patients since weight~     loss gives the patients an extra motivation to take medication regularly. Similarly, the~     patient does not require to take an insulin injection before each meal throughout the day in~     this approach.~      Unfortunately, there are still a large number of patients with poor glycemic control who are~     still on MDI. Some of them were initiated on MDI before the availability of newer generations~     of medications. Some were started simply because the physician was not aware of or not the~     familiar with the new recommendations. Regardless of the reason, these patients are likely to~     remain on MDI despite chronic poor glycemic control since the physicians are understandably~     reluctant to step down the most advanced insulin therapy. In addition, there has been no data~     on the benefits and safety of the stepping-down approach from the most advanced insulin~     therapy to the more patient-friendly approach that is the combined use of oral SGLT2i and~     once-weekly GLP1 RA injection.~   "
55066|NCT02846220|"~     Over 70% of US adults 65 or older are diagnosed with hypertension, the leading cause of~     cardiovascular disease and premature deaths in the world. Despite availability of effective~     drugs to control blood pressure, uncontrolled blood pressure and low adherence to~     antihypertensive drugs persist as major public health and clinical challenges. On average,~     50% of adults adhere to chronic disease medications and lower levels of adherence are~     associated with worse blood pressure control and adverse outcomes. Many barriers to adherence~     are well known and have been targeted in interventions to improve medication adherence. As of~     yet, no single intervention has emerged as superior or even particularly effective in~     improving adherence. The investigators have recently identified unconscious, self-protective~     'hidden motives' that contribute to nonadherence to chronic disease medications. There is a~     critical need to expand on this insight to test the potential for targeting individuals'~     'hidden motives' for low adherence using an innovative learning process called~     Immunity-to-Change.~      As a critical step in testing this intervention to target these 'hidden motives', the~     investigators will undertake a pilot study to assess the feasibility and acceptability of the~     Overcoming Immunity-to-Change intervention and determine effect sizes of the intervention on~     adherence, blood pressure (BP) control, and quality of life (QOL). The investigators will~     test the Immunity-to-Change intervention in a sample of nonadherent older adults with~     hypertension (n=18). Another sample of nonadherent older adults with hypertension will be~     monitored for comparison (n=18).~   "
55067|NCT02846207|"~     This clinical research is based on the fundamentals of using Chinese medicine, which will~     improve Qi and promote blood circulation, to treat patients in the recuperating stages of~     cerebral infarction with deficiency in Qi and blood stasis syndrome. By assimilating Chinese~     medical theory, this research aims to study the biological basics of the stroke and the cause~     for the deficiency in Qi and blood stasis syndrome; explore the therapeutic mechanism of the~     treatment methods; as well as ascertaining the relationship between Qi, blood and blood~     vessels.~   "
55068|NCT02846194|"~     The purpose of this study is to determine the effect that the Brief Guided Imagery (BGI)~     technique has on fibromyalgia patients suffering from chronic pain in regards to their sense~     of pain, wellbeing and quality of life.~      This study will explore whether daily training of one to two minutes exercises in Brief~     Guided Imagery can reduce chronic pain and improve the quality of life of patients by~     studying specifically patients suffering from fibromyalgia.~      Chronic pain is a common condition which affects person's physical and mental health. It~     occurs in between 10% to 40% of the population, depending on the exact research and chosen~     sample. In 2010 Manchikant et al. found an effect chronic pain has on human functioning and~     quality of life.~      A research from 2007 defined chronic pain as pain that lasts more than three months. Being~     long lasting by its nature, chronic pain has an ongoing effect on deteriorating the quality~     of life. In this regards, quality of life is scientifically determined by five modes: i.~     Physical wellbeing. ii. Mental wellbeing. iii. Social wellbeing. iv. Emotional wellbeing, and~     v. sense of development and self-realization.~      Chronic pain damages daily ongoing functions and is also related to sleep disturbances,~     stress and unemployment. A direct correlation was also found between chronic pain and~     psycho-social .~      One of the many results of chronic pain is the huge impact on the economy, such as absence~     from work due to sick leaves. The overall cost of chronic pain was found to be one percent of~     the total expense on health. The frequency and impact of chronic pain is such that some~     professionals define it as an epidemic.~      In many cases, chronic pain occurs with patients suffering from a wide spectrum of medical~     disorders. In 2007 Tunks et al. demonstrated that chronic pain often accompanies an illness~     that involves also a psychological aspect.~      Both Baird et al. in 2004 and Menzies et al. in 2012 found a significant positive effect~     daily guided imagery exercises have on chronic pain. The study proposes to research the~     specific technique of Brief Guided Imagery on chronic pain, and will focus on patients~     suffering from fibromyalgia.~      Fibromyalgia is a syndrome where a patient suffers from both chronic pain and a fatigue. The~     pain of fibromyalgia is characterized as abstract and non-localized, while the fatigue~     appears in a varying range of intensity. These symptoms are often accompanied by exhaustion,~     lack of energy, somatic disorders and psychologic symptoms such as depression.~      The ongoing pain, fatigue and depression cause fibromyalgia patients to further suffer from~     sleep disorders and diminishing ability to function. Menzies et al. studied in 2012 the~     effect of guided imagery exercises on the stress level, pain, fatigue and depression. The~     study also examined different physiologic blood markers (such as proteins, cytokines and C~     reactive.~      Menzies found a positive and significantly large improvement in the ability to control both~     stress and pain levels, and treat the depression of the participants. However, no significant~     changes were observed in the blood tests monitoring the levels of physiologic markers in the~     blood.~   "
55069|NCT02846181|"~     The primary objectives of the study are:~        -  To assess the mass balance recovery after a single PO dose of [14C]-SK-1405~        -  To provide plasma, urine and faecal samples for metabolite profiling and structural~          identification~   "
55070|NCT02846168|"~     The purpose of this study is to evaluate the predicting role of plasma GLP1 level on major~     adverse cardiovascular events (MACE) in patients with acute myocardial infarction who undergo~     percutaneous coronary intervention.~   "
55071|NCT02846155|"~     By using three different Gastric Preparation of Magnetic-controlled Capsule Endoscopy, the~     investigators hope to find out the optimal gastric preparation plan.~   "
55072|NCT02846142|"~     This trial will consist of three parts: the first two parts will enroll healthy female~     volunteers into a single ascending dose (SAD) and multiple ascending dose (MAD) treatment~     groups.~      The SAD treatment group is comprised of at least 3 cohorts where subjects will be randomized~     to a single dose of either PTI-428 or placebo and will be followed for 7 days post dose. A~     total of 24 subjects are anticipated to participate in this part of the study.~      Following the conclusion of the respective SAD level dose groups and after sufficient review~     of study data and approval by the SRC, a second set of healthy adult female subjects will~     participate in an assigned MAD treatment group. The MAD treatment group is comprised of 3~     cohorts where subjects will be randomized to either PTI-428 or placebo and will be followed~     for a total of 14 days. The SRC will convene after the completion of each cohort to evaluate~     safety, PK and other relevant data. The SRC will determine whether to proceed to the next~     planned dose level, to reduce the dose, or to stop the study. The next cohort may commence~     only after written SRC approval. A total of 24 subjects are anticipated to participate in~     this part of the study.~      Following completion of the SAD and MAD, 40 female healthy volunteers will participate in two~     treatment periods of the DDI study component: Treatment period A will consist of once daily~     oral contraceptive (OC) for 28-days (21-day hormonal active + 7 days off).~      Treatment period B will randomize subjects to PTI-428 or placebo in combination with once~     daily OC for 28 days (21-day hormonal active and PTI-428 or placebo + 7 days off). Following~     completion of the subjects' second treatment period, they will be followed for 7-days after~     their last dose.~   "
55073|NCT02846129|"~     Incidence of anesthesia related complications in multiple gestation patients undergoing~     cesarean delivery has not been reported in Thailand. The aim of this study is to identify~     complications that occur which may derived from different anesthetic techniques used, such as~     hypotension, uterine atony, postpartum hemorrhage, rate of hysterectomy, blood transfusion~     and fetal outcome.~   "
55074|NCT02846116|"~     The aim of this study is to evaluate using of new ceramic material Vita Suprinity and lithium~     disilicate on patient satisfaction combined with shade matching.~   "
55075|NCT02846103|"~     Increasing evidence suggests that immune responses might be a determining factor in lung~     cancer tumor progression.~      The impressive clinical responses obtained with immune checkpoint inhibitors~     (anti-PD-1/PDL-1, anti-CTLA-4) indicate that the presence of preexisting antitumor immune~     response is required for their efficacy and highlight the critical role of antitumor T cell~     immunity. Recent progress on the fields of tumor immunology underlines the critical role of~     CD4 helper 1 T lymphocyte (TH1) in the control of innate and adaptive anticancer immunity.~     Therefore, monitoring tumor specific TH1 response could be relevant in cancer patients.~      In order to monitor tumor-specific CD4 Th1 responses in most cancer patients, the~     investigators group have previously described novel promiscuous peptides (referred as~     UCP:Universal Cancer Peptides) derived from human telomerase (TERT), a prototype of shared~     tumor antigen.~      By using UCP-based immuno-assay, pre-existing UCP-specific Th1 responses have been detected~     in the blood of lung cancer patients (Telocap01). The frequency and magnitude of this~     response were inversely correlate to the disease stage. Furthermore, UCP-specific responses~     were significantly found in patients with low PD1+ and TIM3+ T cells.~      Then in TeloCap02 study, UCP specific Th1 immune responses will be evaluated in lung cancer~     before and after treatment (chemotherapy, immunotherapy).~   "
55076|NCT02846090|"~     Nowadays, a number of cases with increased intraocular pressure and glaucoma have been shown~     a huge increase . This is because of the increase the geriatric population in the community~     and advanced medical care. Surgical correction, as a treatment, solves this problem greatly~     especially with the modern surgical techniques .~      Peribulbar block reduced the admission discharge time and reduced the burden on both the~     patients and the medical team. On the other hand, it carries the risk of increased~     intraocular pressure (IOP). Which, subsequently, limit its usage in glaucoma surgery.~      Dexmedetomidine, as an alpha 2 agonist, has a well-established role in decreasing intraocular~     pressure (IOP). This effect has been shown at a histological level and clinical level~   "
55077|NCT02846077|"~     The project is designed to document in college undergraduates the relationships among~     sleep/wake timing and duration, use of mobile phones and other electronic devices, food~     timing and content, self-reported mood and physiological measures.~   "
55078|NCT02846064|"~     Ovarian cryopreservation is one of the available option for preserving fertility prior to~     potentially sterilizing treatments. In the absence of other techniques such as in vitro~     folliculogenesis or injection of isolated ovarian follicles, this tissue can only be re-used~     by autograft. In France, the first live birth after orthotopic ovarian transplantation, was~     obtained by Roux et al. in 2009. This clinical trial aims to collect data on the efficiency~     of the graft in terms of restoration of ovarian function and live births. It will also allow~     us to carry out the patient follow-up after ovarian tissue cryopreservation and after~     autograft when achieved. In cases of neoplastic malignancies, minimal residual disease~     detection will be performed on ovarian tissue, to avoid any risk of cancer re-seeding.~   "
55079|NCT02846051|"~     Compare the frequency of varicose veins in the lower limbs in a population exposed to~     intensive sport compared to individuals matched by sex, age and body mass index (BMI) did not~     have an intensive sport.~   "
55080|NCT02846038|"~     Honest, clear, and empathetic communication between pediatric oncologists (POs) and parents~     of children with cancer (POCCs) is imperative to facilitating therapeutic alliance and~     ensuring that medical management aligns with the families' goals of care. Communication is~     particularly important during conversations about disease reevaluation, which often~     necessitate parental decision-making in the context of emotional distress. POs employ a~     spectrum of communication styles and strategies during challenging conversations, and there~     is no consensus regarding linguistic or thematic metrics for high quality communication of~     upsetting information. In order to better understand how POs communicate difficult~     information to POCCs, the investigators propose a pilot study designed to accomplish the~     following primary aim:~      Primary Objective:~        -  To identify recurrent verbal and nonverbal (e.g. the use of pauses/silence)~          communication techniques employed by POs in the delivery of difficult prognostic~          information to POCCs through content analysis of audio-recorded conversations between~          POs and parents of children with high risk cancer at the time of disease reevaluation.~      The study expects to enroll up to: 80 patient participants, 80 parents, and 15 primary~     pediatric oncologists (total = 175).~      Non-primary oncologist members of the clinical care team, extended family members, or friends~     of the family may also participate, if they choose to do so.~   "
55081|NCT02846025|"~     ABSTRACT~      Epigenetic mechanisms may be involved in the regulation of lipid metabolism and inflammatory~     markers may therefore contribute to the cardiovascular risk profile, as well as environmental~     factors have a significant impact on the epigenetic program of gene expression. Methyl groups~     are usually added or removed as needed and can be influenced by diet soon, dietary factors~     have been linked to the change of DNA methylation, resulting in changes in gene expression.~     Research on the prevalence of gene methylation levels on the impact of nutrient intake, as~     well as the inflammatory condition and the results of dietary interventions for the genes, it~     is a sparse area in studies and, therefore, expanding of the knowledge. Thus, understanding~     the effects of a diet rich in antioxidants and hazelnut oil, in inflammation and DNA~     methylation profile is important because chronic diseases with cardiovascular disease can~     begin with the consumption of modified lipids and can research this stage provide important~     dietary allowances for the development of this disease prevention strategies even in~     adulthood. This PhD project is linked to a larger project entitled II Diagnosis Cycle and~     Intervention Food Situation, Nutrition and Noncommunicable Diseases Prevalent over the City~     Population of João Pessoa / PB (II DISANDNT / PB) and have two methodological designs: the~     first one is the composition of a representative sample of adults in the city of João Pessoa,~     from II DISANDNT / JP, population-based study and cross-sectional. The second methodological~     design was developed with a subsample of the above population, selected from criteria being~     the type and interventional clinical trial. This model will have to evaluate the effect of a~     diet rich in antioxidant and hazelnut oil, in inflammation and gene expression.~   "
55082|NCT02846012|"~     The purpose of this study is to collect development and outcome data on human embryos which~     are cultured in a 2nd generation continuous single culture medium (CSCM2) with the objective~     to demonstrate its performance efficacy in comparison to existing commercially available~     single culture or continuous embryo culture media.~   "
55083|NCT02845999|"~     Gastrointestinal (GI) cancers account for the most common cancers. Despite recent advances in~     GI cancer treatments, the 5-year overall survival rate for these patients remain~     unacceptable, except for patients who are candidates for metastasis surgical resection.~     Strategies leading to a decrease of metastatic number and size will contribute to improve the~     probability to undergo a curative surgical procedure.~      Haploidentical Natural Killer (NK) cells can persist and expand in vivo following adoptive~     transfer and may have a role in the treatment of selected malignancies, since the failure to~     recognize the appropriate KIR ligand on a mismatched tumor cell can trigger NK cell~     elimination of that target cell. NK also express an activating Fc receptor that mediates~     antibody-dependent cellular cytotoxicity (ADCC) and production of immune modulatory cytokines~     in response to antibody-coated targets. Cetuximab, an IgG1 chimeric monoclonal antibody~     against colorectal cancers that expressed EGFR (epidermal growth factor receptor), improves~     overall survival and progression-free survival and preserves quality-of-life measures in~     patients with colorectal cancer in whom other treatments have failed.~      In an attempt to improve the outcome in GI cancers, we will conduct a phase I/II clinical~     trial assessing NK cell based immunotherapy. Patients with liver metastases related to a~     EGFR+ GI cancer, previously treated by a standard chemotherapy that did not achieve a~     complete response or a curative resection of residual metastases will be included in this~     phase I/II trial supported by the French National Institute of Cancer (INCA, PHRC 2005). This~     phase I/II study will involve 22 patients. The main objective of this study will be to~     demonstrate the safety of NK hepatic intraarterial infusion in association with cetuximab.~     Secondary objectives will include the assessment of the clinical efficacity of this strategy.~   "
55084|NCT02845986|"~     The purpose of this study is to explore the safety and feasibility of the Laparoscopic~     Spleen-Preserving No. 10 Lymph Node Dissection for patients with locally advanced upper third~     gastric adenocarcinoma（cT2-4a, N-/+, M0）.~   "
55085|NCT02845973|"~     The aim of the study is to identify and verify one or more gut bacteria of which the~     abundance in feces may help to early diagnosis colorectal cancer.~   "
55086|NCT02845960|"~     The purpose of this study is to evaluate the influence of rapid recovery on sleep quality~     following total knee replacement surgery.~   "
55087|NCT02845947|"~     This study seeks to research the effects of music therapy during pediatric extubation~     readiness trials. Amount of sedation, physiological measures, and parent/staff satisfaction~     surveys will be measured.~   "
55088|NCT02845934|"~     This Study evaluates the performance (sensitivity, specificity, positive and negative~     predictive value values and likelihood ratios) of the DNA detection test for the diagnosis of~     mucormycosis by comparing it to the routine tests such as CT scan aspects, histopathology,~     microscopy and fungal culture, in a test group of 52 patients including :~        -  patients at high-risk according to the EORTC/MSG criteria (patients with prolonged~          severe neutropenia, receiving corticosteroids or T-cell suppressors, recipients of~          allogeneic HSCT, or inherited severe immunodeficiency),~        -  patients with other predisposing factors of invasive mould disease ( diabetes, AIDS,~          haematological malignancies or solid tumours, trauma, burns); Patients already diagnosed~          with probable or proven mucormycosis irrespective of underlying conditions.~   "
55089|NCT02845921|"~     Propofol is an intravenous anaesthetic agent used for both induction and maintenance of~     anaesthesia. An important adverse effect is the significant fall in blood pressure. The~     current clinical study will be done to determine the efficacy of leg elevation and wrapping~     in reducing the incidence and severity of propofol induced hypotension in patients undergoing~     general anaesthesia.~   "
55090|NCT02845908|"~     The aim of this study was to compare the efficacy and safety of POF, FOLFOX, and FOLFOX plus~     paclitaxel(ip) as first-line treatment in AGC a phase II clinical trial.~   "
55091|NCT02845895|"~     The prevalence of malnutrition in hospital is very high (30 percent) with major consequences~     in terms of morbidity and mortality, generating significant health care costs. The positive~     impact of its support is demonstrated.~      The HAS (French High Sanitary Authority) recommends a screening of all adult hospitalized in~     the first 48 hours, with no consensus regarding the organization of screening within care~     services. Various strategies have been implemented. Although this screening is part of the~     nursing role, old and recent studies show that it is not done systematically and nutritional~     disorders are largely under-diagnosed and therefore untreated.~      The investigators assume that an organization of screening for eating disorders, based on a~     caregiver dedicated to this activity, improves the indicator IPAQSS (Indicateurs Pour~     l'Amélioration de la Qualité et de la Sécurité des Soins) which is an indicator for the~     improvement of the quality and security of care) Screening indicator of nutritional disorders~     Level 3, compared to an organization classic involving the care teams in their entirety.~     This indicator reflects the care system performance.~      In this study, patients will have no intervention. Only the organization of the care staff~     will be adapted but with no changes on the care of patients?~   "
55092|NCT02845882|"~     The outcomes of children with lymphoblastic lymphoma (LBL) in China in the investigators'~     previous study were not unexpected. In this study, through further modification treatment~     protocols and strengthen domestic multicenter collaboration, the investigators try to improve~     survival for children with LBL when compared to the previous study.~   "
55093|NCT02845869|"~     During basic training, 15% of military recruits develop knee pain, which hinders their chance~     to complete training. Current therapeutic options have had variable levels of success. Light~     therapy was shown to reduce pain in chronic inflammatory related knee pathology. The current~     clinical study is designed to evaluate light therapy, as an adjunct to conservative~     physiotherapy for treatment of acute overuse KP in combat soldiers.~   "
55094|NCT02845856|"~     The aim of this study is the safety and efficacy of Cetuximab plus natural killer(NK)~     immunotherapy to recurrent non-small cell lung cancer with EGFR mutation.~   "
55095|NCT02845843|"~     This is a placebo-controlled clinical trial to assess the feasibility, efficacy and safety of~     a combination of lopinavir/ritonavir and Interferon beta-1b in hospitalized patients with~     MERS.~   "
55109|NCT02845661|"~     Narcotrend index is a widely used quantitative parameter for evaluating anesthesia and~     sedation levels.Dexmedetomidine is a novel sedative,providing sedation while patients remain~     cooperative and can be easily aroused. This study was designed to explore the correlation of~     Narcotrend index and OAA/S scale in monitoring sedation level with different single- doses of~     dexmedetomidine intravenously.~   "
55110|NCT02845648|"~     To evaluate the effect of controlling lower urinary tract symptoms (LUTS) with~     anticholinergics on improving the ability to awaken (AA) in children with nonmonosymptomatic~     enuresis and evaluate the potential implication of improved AA for treatment response~     prediction.~   "
61002|NCT02768415|"~     The hypothesis of this study is to discover if the all-oral therapy with apatinib plus oral~     vinorelbine can shrink or slow the growth of pretreated HER2 negative metastatic breast~     cancer.~   "
55096|NCT02845830|"~     Maintaining of improving the quality of life amongst the elderly with early phase dementia~     (EwD) is nowadays one of the key aims of health care services. When investigating the quality~     of life trajectories, it is necessary to examine contributing factors. The aim of the project~     is to ascertain the profile of quality of life trajectory amongst Czech EwD and to identify~     the most important factors affecting it. The results will be compared to the results from the~     elderly without dementia. A quantitative approach, longitudinal prospected design utilising a~     battery of questionnaires in the Czech language will be used. At the same time, translation~     and validation of the Czech version of QOL-AD and PDI will be carried out. The group of~     respondents will include EwD and elderly without dementia living in home environment.~     Knowledge of the quality of life trajectory and the factors involved will enable~     interventions to maintain or improve the quality of life of the elderly with early-stage~     dementia in home environment in future. Project Aims The aims are to ascertain the quality of~     life trajectory profile amongst the elderly with early phase dementia, to identify the most~     important factors involved and to compare the results to control group. Validation of the~     Czech versions of QOL-AD and PDI questionnaires will be performed.~   "
55097|NCT02845817|"~     This study take place in the palliative care units of Burgundy-Franche-Comté regions and at~     the Maison Médicale Jeanne Garnier. The main aim of this project is to analyze and understand~     the meaning of explicit requests to hasten death (euthanasia and assisted suicide).~      This involves conducting interviews with patients, carers to whom the request has been~     expressed and a relative chosen by the patient. This study aims to describe the request over~     time. This will be done through two series of interviews, one as soon as it is first~     expressed, then one week later.~   "
55098|NCT02845804|"~     The objectives of this study are~        1. To establish a prospective registry of the whole patients who received percutaneous~          coronary intervention with Xience Xpedition™/Alpine™ stent~        2. To evaulate the long-term efficacy and safety of coronary stenting with the Xience~          Xpedition™/Alpine™ stent~        3. To compare the long-term efficacy and safety of coronary stenting between the Xience~          Xpedition™/Alpine ™ stent and other contemporary drug-eluting stents which had~          established their own registry~   "
55099|NCT02845791|"~     To investigate whether the interactive family based lifestyle programme leads to behaviour~     change at 6 months with the primary outcome being increased levels of moderate to vigorous~     physical activity (MVPA).~   "
55100|NCT02845778|"~     Melatonin is an endogenous hormone. It is able to promote nighttime sleeping and could induce~     sleep at daytime in adult and children with the nonpainful diagnostic procedure. However,~     previous formulation had problems of unstability of product and low oral bioavailability.~     Melatonin niosomes oral gels are formulated in order to overcome the problem of drug~     absorption and stability. This study is a randomized, double-blind, three phase crossover~     design in 15 male volunteers. Melatonin niosomes oral gel will be applied at doses 2.5, 5,~     and 10 mg with 7 days washout for each period. The pharmacokinetics data, sleep induction~     effect, and adverse event will be determined.~   "
55101|NCT02845765|"~     The purpose of this study is to evaluate the correlation between fundus oculi's~     vascularization in patients with erectile dysfunction and not, and, in the same patients,~     before and after using drugs for ED.~   "
55102|NCT02845752|"~     The purpose of this study is to determine whether exercise can be prolonged in COPD can by~     the inhaled bronchodilator Stiolto Respimat. The study will identify whether any endurance~     benefit is due to reduction in fatigue that originates within the skeletal muscles and/or~     from effects on neural activation of the skeletal muscles.~   "
55103|NCT02845739|"~     The main goal of project is to study the distribution of HPV genotypes in the anogenital area~     and peripheral humoral immune responses HPV (total and neutralizing Ab) before and after~     renal transplantation. Furthermore, the investigators wish (i) establish whether there is a~     correlation between HPV infection and HPV immune response before and after transplantation,~     and (ii) determine whether there is a link between HPV infection and immunosuppression.~   "
55104|NCT02845726|"~     This study is performed to analyze various aspects of biofilms on ureteral stents.~   "
55105|NCT02845713|"~     The study will be an open label cohort study with 2 two-treatment groups 2). Both groups will~     be treated with a single oral administration of Diethylcarbamazine (DEC) 6 mg/kg +~     Albendazole (ALB) 400 mg + Ivermectin (IVR) 200 µg/kg (IDA). One treatment group will include~     men and women with W. bancrofti infections (>50 Mf/ml, N=30). The other treatment group will~     include men and women who are free of W. bancrofti infection based on negative blood tests~     for both microfilariae (Mf) and circulating filarial antigen (N=30). Active follow-up for~     adverse events (AE) will be for 72hrs and passive follow-up for 7 days following treatment.~      Participants will be followed again at 1 year to evaluate treatment efficacy. Individuals~     with severe AEs (grade 3 or higher) will be transported to the Agboville District Hospital~     and cared for by the hospital staff. Based on treatment of over 100 Lymphatic filariasis (LF)~     infected individuals any AEs develop within the first 72 hours following treatment and~     uncommonly up to 7 days post-treatment.~      All individuals will be admitted to a single health center or hospital in Côte d'Ivoire.~      Subjects will be monitored for 72-hours after treatment for safety and to facilitate sampling~     for drug analyses and safety tests. Participants will undergo clinical monitoring every 6~     hours to evaluate potential adverse effects of Ivermectin + Diethylcarbamazine + Albendazole~     (IDA) treatment. Participants will also be monitored for hematologic, or biochemical~     abnormalities during the period of observation.~   "
55106|NCT02845700|"~     The study will use a prospective design consisting of three phases. The phases are:~        1. the development of the sensory retraining treatment (SRT),~        2. the evaluation of the treatment's feasibility and acceptability, and~        3. an assessment of its efficacy.~      During the third phase, a pilot study will be conducted in which participants will be~     randomly assigned to either SRT or a waitlist control group in order to assess efficacy.~     Diagnostic information and eligibility criteria will be assessed using the Structured~     Clinical Interview for DSM-IV (SCID) and the Clinician Administered PTSD Scale for DSM-5~     (CAPS-5).~   "
55107|NCT02845687|"~     The purpose of this study is to conduct an observational assessment of natural outcomes~     within the Duke Smoking Cessation Program (DSCP), Quit at Duke. This assessment will~     include information regarding abstinence rates, changes in patient emotional state following~     treatment, and costs of operations. Primarily, this study will assess the financial~     sustainability and the cost-effectiveness of the program.~   "
55112|NCT02845622|"~     This study aims to assess the effects of hazelnuts, cocoa, and the combination of both on~     vascular reactivity and metabolic profile. Participants, divided in six groups, will receive~     one of these breakfast integrations for 14 days:~      group 1) 30 g peeled hazelnuts;~      group 2) 30 g unpeeled hazelnuts;~      group 3) snack with 30 g peeled hazelnuts;~      group 4) snack with 2.5 g cocoa powder;~      group 5) snack with 30 g peeled hazelnuts and 2.5 g cocoa;~      group 6) empty snack, control group.~   "
55113|NCT02845609|"~     Sialic Acid-Extended Release (SA-ER, aceneuramic acid, UX001) is an extended release~     formulation of sialic acid (SA, also known as N-acetylneuraminic acid or NANA). The SA-ER is~     currently studied as a substrate replacement therapy for patients with GNE myopathy. The~     investigators plan to study the SA-ER compound in a cohort of five patients with GNE-related~     thrombocytopenia.~   "
55114|NCT02845596|"~     The purpose of this study is to determine the feasibility of comparing outcomes of patients~     treated de novo with immunosuppressive therapy (IST) versus matched unrelated donor (MUD)~     hematopoietic stem cell transplant (HSCT) for pediatric acquired severe aplastic anemia.~   "
55115|NCT02845583|"~     the study consists of an observational study aimed at quantifying the economic burden of the~     nursing activities on the overall cost of hospitalizations funded through DRG tariffs for~     Major complexity oncology patients.~   "
55116|NCT02845570|"~     Imaging using 68Ga-DOTANOC PET (positron emission tomography) has the potential to detect~     granulomas in pulmonary tuberculosis, leading to previously unexplored indications for this~     PET tracer, including identification of subclinical disease in latently infected individuals.~     This study aims to assess the ability of 68Ga-DOTANOC PET/MRI to detect pulmonary lesions in~     individuals with active pulmonary tuberculosis.~   "
55117|NCT02845557|"~     Early onset type 2 diabetes mellitus among adolescents/youth (YT2DM) is a rising phenomenon.~     The pathophysiology has been studied primarily on non-Asian populations while literature on~     incretin effect is scarce. The investigators evaluated insulin sensitivity, beta-cell~     function, incretin hormones and their effect in YT2DM from a multiethnic Malaysian~     population. The characterization of this population may enable us to better tailor their~     antidiabetic care.~   "
55118|NCT02845544|"~     The study of the behavior of the mechanisms of body balance with a workout based on the~     Pilates method can facilitate the development of more accurate rehabilitation approaches.~     However, there is still little scientific information on its effects on the locomotor system~     and it's necessary to search for new methods to evaluate its strategies more specifically.~     Thus, this study aims to determine whether an exercise program based on Pilates method has~     influence on the static and dynamic postural balance of sedentary adults. This is a~     randomized controlled trial, which will be developed with an initial sample of 20 subjects of~     both sexes, aged between 18 and 30 years, divided into two groups: a control group and an~     experimental group. Participants with physical activity time up to 150 minutes per week will~     be included, assessed by the International Physical Activity Questionnaire (IPAQ), and those~     who have no experience with the Pilates method. In the experimental group a workout program~     will be done for 6 weeks with individual classes including exercises based on the Pilates~     method, during 1-hour, twice a week. Assessments will be made prior and after the training~     program with anamnesis, anthropometric measurements and also the Balance Error Scoring System~     and the Star Excursion Balance Test Y to assess postural balance. During the tests and~     training program exercises the muscle activity of paraspinals and transversus abdominis will~     be analyzed using surface electromyography (sEMG), and body mass center displacement will be~     measured with a triaxial accelerometer positioned on the fifth lumbar vertebra. The data will~     be entered in a spreadsheet and statistically tested with SPSS software. The tests will~     include the comparison of means, association, correlation and effect size, which will be~     chosen according to the distribution of the data and will use the 5% significance level for~     all tests.~   "
55119|NCT02845531|"~     The purpose of this study is to determine whether ICD(Implantable Cardioverter Defibrillator)~     implantation on the top of optimal medical therapy in patients with variant angina~     manifesting as aborted sudden cardiac death reduces the incidence of the death from any cause~     compared with optimal medical therapy alone.~   "
55120|NCT02845518|"~     Pulmonary arterial hypertension (PAH) is characterized by a progressive increase in pulmonary~     vascular resistance leading to right ventricular (RV) failure and eventually to death. The~     therapeutic strategy has become complex and needs to perform recurring follow up evaluations~     including a right heart catheterization (RHC).~      Cardiac magnetic resonance imaging (cMRI) has the advantage to accurately assess right~     ventricular (RV) volumes and important prognostic predictors such as cardiac index, stroke~     volume (SV) and right ventricular ejection fraction (RVEF).~      The main objective is to assess the hemodynamic diagnosis performances (sensibility and~     specificity) at baseline and at follow up visits of cMRI to detect an unfavorable hemodynamic~     status in comparison with the results of the RHC (current guidelines).~      The primary endpoint is: sensitivity and specificity of cMRI for the diagnosis of an~     unfavorable status defined by the current RHC criteria (with 95% confidence interval).~      The secondary objectives are: to identify clinical and hemodynamic variables independently~     contributing to prognosis, to quantify complications due to cMRI and to RHC and to compare~     acceptability and tolerability of cMRI over RHC for the patient.~      PAH patients will be recruited in 18 centers of the French network of severe pulmonary~     hypertension in a prospective cohort study.~      180 subjects will be enrolled in the study: that size will give the study 90% power to find~     significant at the 5%-level.~      If the primary endpoint were reached, since first, strategies and procedures planed in this~     project are consistent with those currently used in routine and second, inclusion criteria~     are not limited to a sub-population of PAH patients, positive results could allow to broadly~     extending our findings. Therefore, it will be possible to decrease the number of RHC, an~     invasive and cumbersome procedure without altering the prognosis. Moreover all clinical~     procedures would be performed in outpatient clinics and thereby would reduce the cost to~     assess the severity of the disease. Current recommendations for evaluation of severity and~     follow-up being mainly derived from consensus of opinion of the experts, positive results~     will also improve the level evidence of severity assessment of PAH patients.~   "
55121|NCT02845505|"~     The aims of this study are 1) to identify IVUS determinants of the CAMS-derived myocardial~     territories subtended to the diseased vessels, 2) to find IVUS determinant for the extent of~     CAMS-derived myocardial size, and 3) to develop the mathematical model that integrates the~     IVUS information about myocardial territory and stenosis severity and predicts the extent of~     CAMS-derived myocardial size.~   "
55122|NCT02845492|"~     This study compares Qigong movement-based meditation exercise with a healthy living~     exercise-wellness course. There are two primary goals of this research:~        1. Evaluate and compare physiological mechanisms underlying the two wellness-exercise~          interventions with the specific goal of understanding the physiology of Qigong.~           Using a simple noninvasive EEG setup, the study will test some of the same brain~          mechanisms that have been found in mindfulness meditation.~           The study will also investigate Qigong's effects on stress and heart signals and on~          inflammation in the immune system. A key hypothesis is that Qigong will show~          distinctive, stronger effects on brain and heart measures. A related hypothesis is that~          Qigong will show stronger effects on blood markers of inflammation.~        2. Compare effect sizes of the two interventions in decreasing fatigue in order to plan for~          a larger clinical trial.~   "
55123|NCT02845479|"~     Stage I of the Thoracic-POISE study will pilot-test a broad-based, multi-agent integrative~     care intervention delivered by naturopathic doctors in conjunction with standard surgical and~     oncologic care of people with thoracic cancer.~   "
55124|NCT02845466|"~     Leg and foot ulcers due to venous disease or diabetes are chronic wounds that can take 6 or~     more months to heal. Growth factors have been used to try and improve this healing, however,~     many such studies have failed, and that is thought to be due enzymes in the wound that~     degrade the growth factors and prevent them from working. This is a proof of concept study~     that will evaluate the treatment of chronic leg ulcers with topically applied growth factors~     that are combined with a therapy to prevent their inactivation in the wound.~   "
55125|NCT02845453|"~     The purpose of this study is to determine whether quetiapine is effective in the treatment of~     youth with co-occurring substance use disorders and bipolar disorder.~   "
55126|NCT02845440|"~     The overall aim of this study is to test the effect of academic detailing (i.e.~     provider-level educational intervention focused on evidence-based smoking cessation treatment~     for those with psychiatric illness), alone or in combination with practical support from a~     community health worker, on the provision and utilization of standard of care smoking~     cessation treatment to those with serious mental illness (SMI). Further, this study will~     determine if these interventions improve smoking cessation rates for adults with SMI who~     smoke.~   "
55127|NCT02845427|"~     Comparative randomised study to clarify which better to use or no use of closed suction drain~     system after total hip arthroplasty regarding amount of blood loss, need for blood~     transfusion, risk for superficial infection, ecchymosis, wound discharge, effect on early~     post-operative rehabilitation. Patients will be followed up for one month postoperative~     clinically (Harris Hip score system), laboratory (Hb level), and radiologically (A-P view~     plain x-ray of the hip).~   "
55128|NCT02845414|"~     This is a single center, phase I dose escalation study designed to determine the maximum~     tolerated dose (MTD) or recommended phase 2 dose (RP2D) of deimmunized CD133KDEL~     (dCD133KDEL), a ligand-directed, deimmunized pseudomonas toxin against CD133, in patients~     with advanced, previously treated, refractory solid tumors.~   "
55129|NCT02845401|"~     The investigators' research is aimed at developing more effective, finite approaches for~     managing individual patients with chronic hepatitis B (CHB). This prospective clinical and~     basic scientific study exclusively focuses on patients with the early antigen negative form~     of disease, which in developed countries is treated indefinitely with antiviral drugs. The~     investigators' study BeNEG-DO, directly offers patients who are already taking standard~     oral Hepatitis B Virus (HBV) antiviral therapy for at least 192 weeks the option to stop or~     continue treatment. Drawing on data from pilot studies, including the investigators' own~     University of California, San Francisco and Sutter Institutional Review Board-approved study,~     the investigators will examine a finite HBV treatment strategy on clinical outcome and~     safety. In conjunction, the investigators will study immunologic mechanisms and gene~     expression profiles that correlate with and predict the post-treatment clinical course. The~     BeNEG-DO study could seriously question, and potentially change, the current treatment~     paradigm for millions of patients with CHB and also lead to new disease-terminating antiviral~     therapeutics.~   "
55130|NCT02845388|"~     Comparison between usage of Sildenafil citrate with estradiol valerate or estradiol valerate~     alone in endometrial preparation and outcome of frozen-thawed embryo transfer cycles.~   "
55131|NCT02845375|"~     In this study the investigators will assess (i) the effect of partial neuromuscular blockade~     (NMB; TOF ratio 0.8 and 0.6) induced by low-dose rocuronium on the ventilatory response to~     isocapnic hypoxia and (ii) the effect over time (from TOF 0.6 to TOF 1.0) of the reversal by~     sugammadex, neostigmine or placebo in healthy volunteers.~      Additionally the investigators will assess the effect of partial NMB (TOF ratio 0.6) induced~     by low-dose rocuronium on the ventilatory response to hypercapnia and effect over time (from~     TOF 0.6 to TOF 1.0) of the reversal by sugammadex, neostigmine or placebo in healthy~     volunteers.~   "
55132|NCT02845362|"~     Measurements of dysphagia severity are important when making management decisions and in the~     objective evaluation of swallowing impairments. The Sydney Swallow Questionnaire (SSQ) is a~     validated self-report inventory using a visual analogue scale. This questionnaire permits a~     quantitative, sensitive, specific, repeatable and easily responsive evaluation of dysphagia~     in different pathology. Opposed to largely used videofluoroscopy swallowing study and~     endoscopy examinations, the SSQ is noninvasive, less expensive, avoids radiation exposure and~     enables a readily available assessment. Validated French version is not yet available. In the~     first phase of the study the investigators will validated this translation in dysphagic~     patients and control. Secondly, the investigators will validate the SSQ in Neuromuscular~     patients.~   "
55133|NCT02845349|"~     Traumatic brain injury (TBI) is a major public health problem with an annual incidence of~     about 1.7 million per year. TBI is associated with various long-term morbidities. Among them,~     psychiatric disturbances are the major cause of chronic disability and poor quality of life.~     Major depression is the common psychiatric sequela post TBI with rates ranging from 13% at 1~     year to 60% at 8 years after TBI. Major depression after TBI (henceforth referred to as TBI~     depression) is often associated with comorbid neuropsychiatric symptoms (NPS) such as~     anxiety, aggression, substance abuse and cognitive deficits that often makes treatment~     difficult. Despite increased rates of depression, there is no Food and Drug Administration~     (FDA) approved drug/s for its treatment.~      The investigators propose to address these limitations by use of a novel serotonergic agent,~     vortioxetine, which has a multimodal mechanism of action through serotonin transporter (SERT)~     inhibition, 5-hydroxytryptamine (5-HT)3, 7, and 1D receptor antagonism, 1B receptor partial~     agonism, and 1A receptor agonism.~      Overarching Goal: The overarching goal of the proposed pilot study is to determine the~     effectiveness and safety of vortioxetine for the treatment of post-TBI depression and~     co-morbid NPS.~      Study Design: The study design will include a DBPCT of 30 TBI patients of all severities who~     meet the DSM 5 criteria for major depression. A total of 150 will be consented to allow for~     screen failures. Written informed consent will be obtained from these patients. Subjects will~     be followed for a total of 12 weeks. Subjects will be randomized to either the vortioxetine~     arm (N=15) or placebo arm (N=15). The treatment group will receive vortioxetine 10mg per day,~     which will be increased to 20 mg or decreased to 5 mg, if deemed clinically necessary, at~     week 4 or 8. Subjects will have a total of 4-5 visits: Baseline evaluation (1 or 2 visits)~     and follow-up visits at weeks 4, 8 and 12. Well-validated psychiatric instruments will be~     used to compare the effectiveness of vortioxetine versus placebo treatment at week 12~     compared to baseline Relevance: This study has the potential to provide strong preliminary~     evidence for the use of vortioxetine as a safe and novel agent for treatment of TBI~     depression and its psychiatric co-morbidities. If found to be effective, results from this~     study can be used to design larger studies and also determine brain changes associated with~     its use via neuroimaging.~   "
55163|NCT02844959|"~     The aim of this study is to evaluate inflammatory response as a prognostic factor of atrial~     fibrillation recurrency after ablation. Inflammatory response will be assessed by double~     measurement of C-reactive protein, fibroblast growth factor 2 (FGF2), matrix metallopeptidase~     8 (MMP8) and body temperature. Dynamics of change of troponin I will be measured~     additionally.~      After ablation each patient will be monitored with ECG telemonitoring system for 7 days.~   "
55134|NCT02845336|"~     Thyroid eye disease (TED) is an autoimmune disorder in which the immune system attacks~     orbital tissues, resulting in characteristic changes in eyelid position, globe position in~     the orbit, extraocular muscle balance, and optic nerve function. TED is a potentially~     blinding disease, and current treatments largely consist of nonspecific reduction of~     inflammation using corticosteroids or radiation therapy. Regardless of treatment, once TED~     progresses from its inflammatory phase to a more fibrotic, resolution phase, the orbital~     changes become fixed and can be modified only by surgery.~      The investigators propose to treat a cohort of patients with active TED using a selective~     COX-2 inhibitor, celecoxib, and to compare these patients to an observational control group.~     The investigators hypothesize that celecoxib will reduce the severity of disease and/or~     prevent progression to proptosis, diplopia, and corneal exposure or compressive optic~     neuropathy.~   "
55135|NCT02845323|"~     This study evaluates the post cystectomy CD8+ tumor response of patients receiving Nivolumab~     plus Urelumab versus Nivolumab alone. Half the patients will receive Nivolumab plus Urelumab,~     while the other half will receive Nivolumab alone.~   "
55136|NCT02845310|"~     The aim of this study is to compare the use of Goal Directed fluid therapy guided by Stroke~     volume variation plus a restricted fluid management approach to standard fluid management in~     patients undergoing major abdominal operations.~   "
55137|NCT02845297|"~     This is a multicenter, nonrandomized, open-label phase 2 study (with a safety run-in phase)~     of azacitidine (AZA) 75 mg/m2 given IV or SQ on days 1-7 every 28 days in combination with~     pembrolizumab 200 mg given IV every 3 weeks (starting on day 8 of cycle 1). The dose/schedule~     of AZA selected for this study is FDA approved for patients with MDS/AML.~   "
55138|NCT02845284|"~     This randomized clinical trial is an adolescent focused implementation science study directed~     at improved social support and prevention of both HIV/STI's and subsequent unplanned~     pregnancies. The study population is pregnant adolescents who are attending antenatal care in~     Kampala, Uganda The acceptability and effectiveness of two enhanced peer lead, reproductive~     health promotion interventions compared to routine health care will be studied. The study~     participants will be individually randomized to one of three arms.~   "
55139|NCT02845271|"~     Primary Objective:~      To assess the efficacy of a single intraarticular dose of GZ389988 compared to placebo for~     relief of knee pain in patients with osteoarthritis (OA) of the knee.~      Secondary Objectives:~      To assess the safety and tolerability of a single intraarticular dose of GZ389988 in patients~     with painful OA of the knee.~      To assess the pharmacokinetic parameters of a single intraarticular dose of GZ389988 in~     patients with painful OA of the knee.~   "
55140|NCT02845258|"~     Patients may evolve pseudocysts of the pancreas secondary to a severe pancreatitis. In case~     of a symptomatic or infected pseudocyst, a therapeutic drainage of the cyst is indicated. In~     modern medicine the preferred way to perform such a drainage is by the means of endoscopic~     ultrasound (EUS). It is not precisely elucidated how this EUS-procedure should be performed~     in different scenarios. The cyst appearance and the drainage stents and/or technique may~     impact the clinical outcome.~      This study is a prospective, single-center observational study on the outcome after~     EUS-guided drainage of pancreatic pseudocysts.~   "
55141|NCT02845245|"~     Comminuted intra-articular distal tibia fractures (OTA 43-C) typically are the result of~     high-energy trauma such as motor vehicle collisions or fall from a height. They are complex~     injuries often associated with significant fragment displacement and severe soft tissue~     injury, a combination that has long challenged orthopedic surgeons. Traditionally, surgeons~     use plain film (X-ray) and CT scans (2 or 3 dimensional) to determine fracture pattern and~     displacement. Yet, in some cases, it is still difficult to identify the relationship among~     bone fragments, which often makes articular restoration challenging. As a result, patients~     with non-anatomic joint reconstructions have a higher rate of poor outcomes.~      The primary objective of this study will be to compare patient outcomes in two groups, one~     group who will receive enhanced pre-operative planning (3D printed plastic prototype +~     standard of care [SOC] imaging with 3D CT scan + plain film radiographs) and a second group~     who will receive pre-operative planning using SOC imaging alone (3D CT scan + plain film~     radiographs only). Patient outcomes collected throughout the 12 month post-operative period~     will include an assessment of radiographic fracture healing (union, non-union, malunion),~     pain using a Numeric Pain Rating Scale, Olerud and Molander Score based on patient's~     self-report, and development of complications (infection, wound healing, re-operation, and~     re-hospitalizations). The secondary objective of this study will be to evaluate whether~     utilizing an enhanced pre-operative plan with a 3D printed plastic prototype altered the~     original pre-operative plan based on SOC imaging alone (3D CT scan + plain film radiographs~     only).~   "
55142|NCT02845232|"~     Blood transfusion requirement represents one of the most significant cost driver associated~     with acute myeloid leukemia (AML). In addition to an increase prevalence of co morbidities in~     older patients, AML in older patients is more often associated with adverse features than in~     younger adults. Physicians might therefore decide to offer palliative or supportive care~     rather than intensive chemotherapy. An alternative treatment could be low-intensity therapy,~     such as LD-AraC or hypomethylating agents, which demonstrated better results than only Best~     Supportive care (BSC). Blood transfusion requirement represents one of the most significant~     cost driver associated with AML.~      The present study assesses the cost-effectiveness of intensive chemotherapy versus Best~     Supportive Care (BSC) versus alternative therapies (hypomethylating agents, low-dose cytosine~     arabinoside (LD-AraC), or other investigational drugs) in elderly patients aged 70 years or~     older regarding blood product transfusions from a French payer perspective. Intensive~     chemotherapy and BSC were the comparators in this analysis, since they continue to represent~     the most commonly used treatment for elderly AML according to the defined status of patients~     considered as 'fit' or 'unfit' for intensive chemotherapy.~   "
55143|NCT02845219|"~     This trial is conducted in Europe. The aim of the trial is to investigate the influence of~     oral semaglutide on pharmacokinetics (the exposure of the trial drug in the body) of~     ethinylestradiol and levonorgestrel in an oral contraceptive combination drug in healthy~     postmenopausal females.~   "
55296|NCT02843217|"~     Aim: Determine the overall effectiveness of a targeted digital messaging intervention at~     improving colorectal cancer (CRC) screening rates compared to care as usual.~      Hypothesis: Screening rates will be higher for patients who receive the digital messaging~     intervention, compared to the control group in which patients receive care as usual.~   "
55144|NCT02845206|"~     Total knee replacement (TKR) is an established treatment for knee osteoarthritis and leads to~     a satisfactory outcome in over 75% of patients. The pain and function after TKR can be~     dependent on the accuracy of initial implantation, as deviation of more than 3 degrees from~     the normal alignment of the limb can lead to abnormal stresses on the implant and accelerated~     failure. Patient specific cutting blocks may result in a more individualised implant~     placement, improved pain and function following surgery, and a long-lasting implant.~      This trial is designed to investigate if there is any benefit to bespoke instrumentation in~     terms of pain and function to the patient, and an economic benefit to the NHS.~   "
55145|NCT02845193|"~     The aim of this trial is to figure out the efficiency of modified Grayson NAM on parents'~     satisfaction, nasal esthetics, interlabial gap and maxillary arch changes. NAM might improve~     and facilitate the surgical procedure after lip closure. This might decrease the need of~     further interventions to improve esthetics and function of CLP patients. This trial will help~     the patients and practitioners in taking the decision of inclusion of NAM in the CLP~     treatment protocol as a mandatory step or skip a useless procedure with all of its burden.~   "
55146|NCT02845180|"~     The purpose of this study is to assess local tissue reaction and retention of an adipose~     allograft extracellular matrix at 3 or 6 months post-injection into the subcutaneous~     abdominal tissue of healthy volunteers scheduled to undergo elective panniculectomy.~   "
55147|NCT02845167|"~     Basic animal research has demonstrated that exercise training can protect the myocardium from~     ischemia-reperfusion injury through several biological mechanisms . This effect of exercise~     training may be beneficial in the perioperative period when cardiac complications may arise.~     However, exercise induced cardioprotection is lost completely within 18 days of stopping the~     training program. This finding from animal research will be used to test the hypothesis that~     3 days of consecutive exercise with the last bout conducted within the last 24/48 hours prior~     to surgery, will have a cardioprotective effect . Specifically, exercise has been shown to~     protect cardiac myocytes against reperfusion induced oxidative stress and mitochondria~     against reperfusion induced damage. This exercise mediated cardioprotection is observed in~     short moderate duration ischemia (i.e. 5-20 min) and moderate to severe (i.e.20-60 min)~     ischemic insults. The effects of exercise induced cardioprotection have only been~     investigated at cell level and it has not been shown whether this will translate into a~     reduction in postsurgical reperfusion injury and associated complications. To study this~     potential cardioprotective effect the investigators will aim to recruit patients who have a~     high risk of receiving reperfusion injury during surgery. Specifically, the investigators~     will recruit abdominal aortic aneurysm patients where the risk of heart complications is~     high. There is also currently no evidence in the published literature with regard to the~     effect of preoperative supervised exercise.~   "
55148|NCT02845154|"~     Post-reperfusion syndrome and ischemia-reperfusion insult are a common well-known~     complication in liver transplantation. Several trials investigated variables that my~     contribute to the generation of these two complications for reducing their incidence and~     magnitude. The investigators will investigate the effect of acute conditioning of the~     recipients circulation to the vasoactive mediators in the graft as well as the congested~     intestine through intermittent purging of graft contents into the patient's systemic~     circulation in living donor liver transplantation.~   "
55149|NCT02845141|"~     The overall objective is the histological and radiological assessment of bony consolidation~     of the tibial/femoral tunnel using either bone graft substitute (Actifuse) or autologous~     spongiosa in patients undergoing revision anterior cruciate ligament reconstruction.~      Clinical correlation with the histological and radiological results using the SF36~     questionnaire.~   "
55150|NCT02845128|"~     Multicentric cohort study recruiting patients admitted to the intensive care unit (ICU) with~     acute respiratory failure (ARF) and receiving treatment with high-flow nasal cannula (HFNC).~      This is a second part of the initial study PF(AG)101/2011 where the investigators created the~     ROX index to predict the need of failure with HFNC treatment in patients with ARF secondary~     to pneumonia, and the investigators want to validate ROX index with this second prospective~     cohort results.~   "
55151|NCT02845115|"~     The aging of the population, and greater exposure to noise, are responsible for an increased~     incidence of hearing loss (presbycusis). This hearing loss is sensorineural disability that~     has become a real public health problem. The main means of rehabilitation of this disability~     is represented by the apparatus of patients with conventional hearing aids. However, these~     hearing aids have several drawbacks that limit their profits, often abandoning the prosthesis~     by the patient.~      Middle ear implants were developed to answer these problems. They are intended to amplify the~     sound signal by transmitting directly to the middle ear to compensate for the hearing loss~     and are indicated in case of failure or contraindication of conventional equipment. However,~     these middle ear implants currently have limitations as performance failure. Recent data show~     that the performance of the ossicles repair techniques are dependent on the coupling of the~     ossicular prosthesis to the ossicles. Furthermore, advances in the understanding of the~     biomechanics of the ossicles confirm the importance of the placement and linkage of surgical~     restoration processes. This data can be applied to middle ear implants to improve~     performance. Indeed, a preliminary experimental study on anatomical parts, using analysis of~     the vibration of the middle ear structures by laser velocimetry, allowed the investigators to~     define the transducer placement method and coupling method to ossicles.~      Investigators wish to validate in vivo results in a pilot study on a small number of patients~     by comparing two surgical techniques guided by velocimetric measures.~   "
55173|NCT02844829|"~     This study will enroll 200 men with clinical suspicion of prostate cancer due to higher serum~     level of PSA than 2.5 ng/ml or abnormal digital rectal examination.~      Anatomical magnetic resonance imaging (MRI) and diffusion weighted imaging (DWI) at 3 Tesla~     (T) magnetic field using surface coils will be used to non-invasively predict the presence or~     absence of prostate cancer.~      Targeted TRUS guided biopsy based on MRI findings will be performed in addition to routine~     twelve core TRUS biopsy.~      Moreover, selected serum and urine biomarkers as well as biomarkers extracted from fresh~     biopsy sample will be collected and correlated with the presence or absence of prostate~     cancer.~   "
55297|NCT02843204|"~     The aim of this study is the safety and efficacy of anti-PD-L1 plus NK immunotherapy to~     multiple solid tumors.~   "
55152|NCT02845102|"~     Depression is common among individuals with chronic illness such as chronic heart failure~     (CHF) or chronic obstructive pulmonary disease (COPD) and is a strong predictor of poor~     clinical outcomes and high rates of avoidable 30-day readmissions. While depression is a~     treatable condition, few people with depression receive effective treatment. The proposed~     study aims to develop a relational agent system to deliver depression treatment to patients~     with chronic illness and comorbid depression. While depression is a treatable condition, less~     than 36% of people with depression receive effective treatment. The proposed study aims to~     design and develop a technology-driven relational agent system to deliver a 6 module, blended~     approach of cognitive behavioral therapy and self-management education (RA-CBT) to support~     patients with CHF or COPD and comorbid depression. The relational agent is a human animation~     program that interacts with patients, integrates best practices from provider-patient~     communication theory, emulating the face-to-face conversational behavior of an empathic~     provider emphasizing nonverbal communicative behavior such as gaze, posture, gestures, etc.~     The RA-CBT program will be accessed via tablet technology by participants. The study~     investigators will conduct a pre-post feasibility study to understand the feasibility and~     acceptability of using the RA-CBT system and its effectiveness in treating comorbid~     depression. If successful, this new approach to depression treatment would immediately expand~     access and scalability for post-discharge mental health support in the care transition.~   "
55153|NCT02845089|"~     A retrospective observational longitudinal medical chart review study of randomly sampled~     patients diagnosed with advanced/metastatic NSCLC. The minimum observational period for each~     patient will be 12 months.~   "
55154|NCT02845076|"~     Noninvasive ventilation (NIV) weaning strategies differ considerably from one another. These~     strategies have yet not been compared to each other. Therefore, the investigators planned to~     perform a prospective, randomized, pilot study involving hypercapnic acute respiratory~     failure patients ready to be weaned off from NIV. The investigators are going to compare the~     success rate of NIV weaning and the duration of NIV after randomization between 3 NIV weaning~     methods: gradual decrease in duration of NIV or level of ventilator support, and abrupt~     discontinuation of NIV.~   "
55155|NCT02845063|"~     The study aims to systematically investigate the interaction between training modality, ACE~     genotype and disease in heart patients whom complete a cardiovascular rehabilitation program.~     This is carried out with the goal to improve the benefit of cardiovascular rehabilitation for~     the patient by maximising adjustments in muscle structure and function with the intervention.~     A population of healthy individuals will be recruited who will carry out the same training~     program, in order to compare the training effects respective to the general population.~   "
55156|NCT02845050|"~     Phase Ib/II study assessing the neo-adjuvant combination therapy of vinflunine with cisplatin~     followed by radical cystectomy in patients with muscle-invasive bladder cancer (JaNEO).~   "
55157|NCT02845037|"~     The purpose of this study is to assess the safety and tolerability of BIA 5-453 after single~     oral doses~   "
55158|NCT02845024|"~     Aim:~      The purpose of this study is to investigate the effect of nonsurgical periodontal therapy~     plus doxycycline on glycemic control in type 2 diabetes mellitus (type 2 DM) patients who~     have periodontitis.~      Materials and methods:~      A total of 24 type 2 DM patients with periodontitis will be selected for the study, and~     randomly divided into two equal groups,who are at least 35 years of age and 16 teeth and type~     II diabetes are (at least the last 3 months of diagnosis of diabetes and its FBS More than~     110 have), and also with periodontal disease are chronic moderate (at least in three areas~     Attachment level to a depth of 3-4 mm maxillary or mandibular been confirmed by clinical~     examination and radiographic signs are being); Takes place. The initial HbA1c Patients should~     be between 7-9 percent over the past three months has changed his medication also found the~     necessary explanations on how to do that consent, Plaque index (PI) by Loe & Silness,~     bleeding on probing (BOP) based on Carter and Barnes (if any bleeding number 1 and its~     absence is 0), probing depth (PD) and clinical attachment levels (CAL) were recorded. Group~     1: (12 patients) was treated with oral hygiene instruction, Scaling, and root planing, and~     doxycycline for 15 days; and Group 2: (12 patients) has the same treatment but with~     placebo, After 12 weeks their periodontal condition and Fasting blood sugar (FBS), glycated~     hemoglobin (HbA1c) level, will be reevaluated.~   "
55159|NCT02845011|"~     The investigators will conduct a randomized, controlled, single-blinded study of patients~     undergoing CPR for cardiac arrest in the mixed medical-surgical ICUs of 12 academic teaching~     hospitals in Iran from August 1, 2016 to February 31, 2017. The intervention and control~     groups were labeled group 1 and 2 respectively. The assessment tool was scored by the~     principle investigator and an ICU nurse. The data analyzer was blinded to group randomization~     and was not present during CPR.~   "
55160|NCT02844998|"~     The purpose of this study is to investigate the relationship between physical activity and~     PE, and determine whether moderate physical activity might delay ejaculation time or be an~     alternative treatment for PE.~   "
55161|NCT02844985|"~     The study is intended to identify gene polymorphisms significantly associated with specific~     behavioral- and preoccupation-typologies of sexual addiction, and to identify additional~     potential genetic markers of sexual addiction. Research subjects with sexual addiction will~     be identified from the out-patient and in-patient populations of the investigative sites.~     Research subjects in the Control Group will be identified from the general population and~     from the student body of selected colleges. Approximately 1100 subjects will be enrolled in~     the study. Anticipating 10% drop-out, this is intended to generate a population of~     approximately 500 men and women clinically diagnosed with sexual addiction, and approximately~     500 healthy men and women who do not meet diagnostic criteria for sexual addiction nor have~     psychopathology who will serve as the control population.~   "
55162|NCT02844972|"~     Decisions to limit and stop active therapeutics are common in the emergency unit. They are~     framed by the Leonetti law of 22 April 2005 recommending the refusal of unreasonable~     obstinacy and care of the patient's pain in later life. The pain assessment is an issue for~     these patients whose in majority, are not communicating. Moreover, no specific tool and the~     teams in charge, not knowing the patient make the recognition and treatment of pain symptoms~     very complex. This is the potential interest of directly involving the family or the person~     of confidence in this management , the first step being the detection and evaluation of pain.~   "
55164|NCT02844946|"~     Traumatic brain injury (TBI) is the signature wound of Veterans returning from the recent~     operations in Iraq and Afghanistan (i.e OIF/OEF/OND), with up to 20 percent experiencing~     persistent post-concussive symptoms. Among Veterans with mild TBI, the majority also~     experience significant distress, including depression and post-traumatic stress disorder, as~     well as persistent pain. Importantly, significant stigma is associated with seeking mental~     health care among Veterans; and poor management of multiple conditions results in increased~     morbidity and mortality, increased risk for suicide, and significantly decreased quality of~     life. Thus the challenge for treatment providers is to provide a unified and acceptable~     intervention for Veterans with these interdependent systemic comorbid concerns. The aim of~     this proposal is to develop, refine, and evaluate a 1-day trans-diagnostic (i.e., applies to~     more than one diagnosis) life skills workshop to help Veterans develop skills needed to~     pursue valued goals in the face of life's challenges.~   "
55165|NCT02844933|"~     The primary objective of this study is to assess the efficacy of Cannabidiol Oral Solution on~     hyperphagia-related behavior in subjects with Prader-Willi Syndrome (PWS). The secondary~     objectives of this study are to assess the efficacy, safety and tolerability, impact on~     quality of life, and impact on physical activity of Cannabidiol Oral Solution in subjects~     with PWS.~   "
55166|NCT02844920|"~     This study is designed to observe the presence or absence of intrauterine adhesions at 6~     weeks after treatment with the Sonata® System through hysteroscopic evaluation by third party~     readers.~   "
55167|NCT02844907|"~     The purpose of this study is to determine the role of basal GLP-1 action on the β-cell~     response to insulin resistance. Healthy subjects will have fasting GLP-1 action determined~     with GLP-1r blockade before and after induction of experimental insulin resistance. We~     hypothesize that fasting GLP-1 action will increase to compensate for experimental insulin~     resistance.~      The study will enroll up to 40 healthy participants and while it is anticipated that the~     screening blood draw will yield a number of screen failures, it is estimated that 10-15~     subjects will complete the entire study protocol. Enrolled participants will be asked to~     complete three study visits including the consent visit and two infusion study visits that~     will include hyperglycemic clamp procedures with the addition of the GLP-1 receptor~     antagonist Exendin (9-39) to determine the fasting GLP-1 effect. Each infusion procedure will~     last 2 hours. Subjects will be asked to take dexamethasone daily for approximately one week~     between Visit-2 and Visit-3 to induce insulin resistance.~      We will enroll 6-10 additional subjects as controls for effects of time and repeat testing.~     These individuals will have identical clamps with no dexamethasone at approximately 1 week~     intervals and will be determined at random by study staff.~      The primary outcome for visits 2-3 will be to measure the effects of Ex-9 on fasting~     glucose-stimulated insulin secretion before and after experimentally induced insulin~     resistance. The primary experimental variable for analysis will be C-peptide during the~     clamp. Mean values will be compared between the period of glucose only stimulation and~     glucose with Ex-9. For each subject in the active treatment arm data will be analyzed using~     2-way ANOVA for repeated measures using time (0-60 vs 60-120 min) and treatment (Dex vs no~     Dex) as the two factors. Based on our previous studies we expect a significant time effect~     due to Ex-9. If there is an interaction with treatment we would conclude that experimental~     insulin resistance influences the fasting GLP-1 effect. Data from control subjects will be~     analyzed identically; here we expect no interaction, indicating that the fasting GLP-1 is a~     stable measure. In our previous study using Ex-9 during a glucose clamp, the average~     coefficient of variation in insulin concentrations at the conclusion of each step in the ramp~     was 30%. Using this estimate of between subject variation, detecting a 20% difference between~     subsequent steps in the GLP-1 ramp with a power of 80% and significance level of 0.05 will~     require 8 subjects.~   "
55168|NCT02844894|"~     This study investigates the effects of dexmedetomidine and esmolol given intravenously before~     intubation on sympathetic response caused by intubation itself. Half the patients will~     recevice dexmedetomidine and the other half will receive dexmedetomidine. Ischemia modified~     albumine levels will be measured~   "
55169|NCT02844881|"~     The study is aimed to evaluate the efficacy and safety of Apatinib and MASCT in patients with~     advanced solid tumors.~   "
55170|NCT02844868|"~     Transcortical direct current stimulation (tDCS) is an emerging technique in the~     rehabilitation of hemiplegic patients after stroke.~      This study aims to assess the observance and the tolerance of repeated tDCS stimulation over~     the primary motor cortex of the lower limb coupled to a motor training program, among~     hemiplegic patients at the sub-acute stage. This is a prospective, randomized, double-blind,~     study with two parallel groups of 15 subjects each. The study will analyze first, the~     patient's observance considered good if 75% of the patients completed the entire protocol~     duration and the tolerance through a questionnaire. The secondary end point will try to~     estimate, if possible, the effect size of the walking performance measured with the~     six-minute walk test and aerobic performance measured with VO2peak of this training program~     compared to the same program combine with placebo stimulations. These evaluations are~     performed before, during and after the rehabilitation program.~   "
55171|NCT02844855|"~     Memory for action is especially important in everyday life although current literature is not~     very abundant. The enactment effect (i.e. better memory for performed actions than for~     verbally encoded sentences) is usually described as a robust effect in aging and can be found~     in many diseases. Although the enactment effect has been studied for three decades, there is~     still no consensus on how it enhances memory. Therefore, in order to gain additional insight~     into the representational basis of the enactment effect, in the present study, the~     investigators propose to test neurological patients. The investigators suggested that memory~     for action should be better than memory for verbally encoded information in Alzheimer's~     disease and Parkinson's disease.~      If patients with Alzheimer's disease (AD) and Parkinson's disease (PD) have no cognitive~     assessment during the last 6 months, then they will realize different tests: MMSE (1), HAD~     (2), a cognitive assessment (3); (4); BREF (5); Assessment of apraxia, (6). Controls will~     perform the same tests to verify that they have no cognitive impairment. Then, two~     experimental conditions will be presented in all patients and controls: a first in which~     participants will have to name drawings (verbal learning) and a second in which they will~     have to reproduce an action associated with drawings (action learning). Immediately after~     this learning phase, a recognition task will be available and therefore participants will~     have to recognize drawings that had been presented previously. The main criteria used in the~     statistical analysis will be the correct recognition score.~   "
55172|NCT02844842|"~     This is an observational prospective study to assess the tolerability and safety of treatment~     of SCIT Allergovac Poliplus polymerized in depot presentation. The study drug will be~     administered either by a 1 day Schedule or by a rapid Schedule (3 increasing weekly doses at~     initiation period till maintenance dose is reached) The study population is both: adult and~     child, polysensitized to at least 2 allergen sources with rhinitis or allergic~     rhinoconjunctivitis. Patients may also present a concomitant mild or moderate asthma.~      The assignment of a patient to a particular therapeutic strategy will not be decided in~     advanced by a trial protocol but will be determined by routine clinical practice. The~     decision of the investigator to prescribe a particular treatment will be clearly dissociated~     from the decision to include the patient in the study. The patients will not suffer any~     intervention, whether diagnostic or monitoring, other than the usual in clinical practice.~   "
55174|NCT02844816|"~     This phase II trial studies how well atezolizumab works in treating patients with non-muscle~     invasive bladder cancer that has come back and has not responded to treatment with Bacillus~     Calmette-Guerin (BCG). Monoclonal antibodies, such as atezolizumab, may block specific~     proteins found on white blood cells which may strengthen the immune system and control tumor~     growth.~   "
55175|NCT02844803|"~     The study is a pilot trial to investigate the effect of Metformin and S. Baicalensis~     Combination Therapy in Type 2 Diabetes Mellitus Patients.~   "
55176|NCT02844790|"~     This trial is conducted in Asia. The aim of this trial is to investigate the pharmacokinetic~     (the exposure of the trial drug in the body) properties of insulin degludec/insulin aspart in~     healthy Chinese subjects.~   "
55177|NCT02844777|"~     This Phase 2 clinical trial is a multi-center, randomized, double-blind, placebo-controlled,~     multiple-dose, parallel-cohort study to assess the efficacy, safety and tolerability of~     VDA-1102 in the treatment of actinic keratosis (AK) on the head of male and female adult~     subjects.~   "
55178|NCT02844764|"~     This is a prospective open-label clinical study of 50 patients to determine safety and~     treatment potential of autologous cell therapy for pain and inflammation associated with~     Osteoarthritis of the hip. Follow-up will consist of a larger sample including 4,000~     patients.~   "
55179|NCT02844751|"~     This is a prospective open-label clinical study of 50 patients to determine safety and~     treatment potential of autologous cell therapy for pain and inflammation associated with~     Osteoarthritis of the knee. Follow-up will consist of a larger sample including 4,000~     patients.~   "
55180|NCT02844738|"~     This is a prospective open-label clinical study of 50 patients to determine safety and~     treatment potential of autologous cell therapy for pain and inflammation associated with~     Osteoarthritis of the shoulder. Follow-up will consist of a larger sample including 4,000~     patients.~   "
55181|NCT02844725|"~     The purpose of this phase 2 study is to evaluate the efficacy and safety of an analgesic drug~     candidate, VVZ-149 Injections. The study is designed as randomized, double-blind, parallel,~     and placebo-controlled study.~   "
55182|NCT02844712|"~     Patients with a complete drug allergy work-up to betalactam antibiotics were contacted (by~     mail) and asked to answer a questionnaire regarding the tolerance upon readministration of a~     negatively tested beta-lactam.~   "
55183|NCT02844699|"~     A Phase Ib2, multicenter, randomized, double-blind, placebo-controlled safety and efficacy~     study evaluating different regimens of the immunotherapeutic drug, Mobilan (M-VM3), in~     patients with prostate cancer.~   "
55184|NCT02844686|"~     New CZT-based SPECT cameras are potentially capable of dynamic 3-D acquisition. Preliminary~     results suggested that dynamic acquisitions could allow the assessment of myocardial flow~     reserve using 99mTc-labelled perfusion tracers. The Flow-Heart study will assess the~     feasibility of myocardial flow reserve measurement by means of 99mTc-DTPA dynamic cardiac~     SPECT in 20 patients.~   "
55185|NCT02844673|"~     To examine the effect of mobile-directly observed therapy (mDOT) on adherence to HU~     (mDOT-HuA) adults with SCA at Muhimbili National Hospital (MNH) in Tanzania.~   "
55186|NCT02844660|"~     A Multicenter, Prospective, Randomized Controlled Comparative Parallel Study To determine the~     safety and effectiveness of EpiCord as compared to standard of care (SOC) therapy for the~     treatment of chronic, non-healing diabetic foot ulcers (DFUs)~   "
55187|NCT02844647|"~     A pilot study with a group of up to 10 men with CRPC about to embark on a 6-month course of~     treatment with radium 223. Study participants will undergo anatomical MR imaging combined~     with the new hyperpolarized MRI (1 hour exam) prior to treatment.~   "
55188|NCT02844634|"~     Men who have sex with men remain at high risk for HIV infection. Targeting prevention~     interventions to MSM at highest risk of seroconversion is an important goal of combination~     prevention interventions. Antecedent diagnosis of another sexually transmitted infection~     (STI), particularly syphilis, may serve as an entry point for biomedical prevention as these~     individuals are at highest risk for incident HIV. The use of the antiretroviral combination~     of tenofovir/emtricitabine has been shown to be associated with an overall 44% reduction in~     HIV acquisition in high-risk MSM when taken daily as PrEP. In those individuals with~     detectable drug levels, the benefit was as high as 90% risk reduction. In real-world~     evaluations of PrEP, high-risk sexual behaviour may continue as evidenced by high rates of~     intercurrent sexually transmitted infections. As such, biomedical interventions that may~     offer additional reduction in acquisition of common sexually transmitted infections should~     also be evaluated.~      Recently a small pilot study has demonstrated potential benefit from a similar strategy for~     syphilis prevention. In this study 30 MSM were randomized to receive either 100mg doxycycline~     once daily or contingency management strategies linked to remaining free of sexually~     transmitted diseases at progressive study visits. Overall, those receiving doxycycline were~     significantly less likely to be diagnosed with any STI during followup than those in the~     comparator arm.~      The investigators therefore propose to undertake a pilot study to evaluate the feasibility of~     using both tenofovir/emtricitabine and doxycycline (immediate or deferred use) for~     pre-exposure prophylaxis amongst HIV-negative MSM with recent history of syphilis infection~     in Vancouver, Canada.~   "
55189|NCT02844621|"~     The purpose of this study is to evaluate the effects of a common over-the-counter medication,~     omeprazole, on the normal gut bacteria and inflammation in the body in healthy older adults.~   "
55199|NCT02844491|"~     Cancer-specific splice variants gain significant interest as they generate neo-antigens, that~     could be targeted by immune cells. CD20, a membrane antigen broadly expressed in mature B~     cell lymphomas, is subject to an alternative splicing named Delta-CD20 leading to loss of~     membrane expression of the spliced isoform.~      The investigators group would now determine if it's possible, in patients with~     lymphoproliferative B, to detect the presence of a specific memory response to delta-CD20~     peptides.~      If this memory response exists, it will confirm the interest of this antigen as a target for~     tumor immunotherapy.~   "
55200|NCT02844478|"~     The purpose of this study is to explore the differences in quality of life , inflammation,~     stress, telomere length, and mucosal immune function of Hispanic and non-Hispanic caregivers~     of persons with Alzheimer's disease and related dementias (ADRD). The caregivers will~     complete the Stress-Busting Program for Family Caregivers in the language of their choice~     (English or Spanish).~   "
55190|NCT02844608|"~     Symptoms related to the disease and/or treatment are common in cancer patients and can affect~     patient health-related quality of life (HRQol). Unfortunately these symptoms can be~     underestimated and underreported by the physician. Measure of the HRQoL has been~     significantly developed in clinical trials and has become a key endpoint to assess clinical~     benefit of new therapeutic strategies and as prognostic factor of overall survival for~     several cancer as in women breast cancer, glioblastomas, metastatic colorectal cancer,~     prostate cancer and hepatocellular carcinoma.~      Moreover, a recent study conducted in patients receiving routine outpatient chemotherapy for~     advanced solid tumors showed that clinical benefits were associated with symptom~     self-reporting during cancer care, including the improvement of the overall survival.~      The aim of the QOLIBRY project is to introduce the collection of HRQoL of cancer patients in~     daily clinical practice in the University Hospital of Besançon. Indeed, the goal is to make~     the HRQoL data accessible and exploitable in real time to physician, to help medical~     professionals to optimize their practices by adopting a holistic and personalized approach~     based on the perception of the patients of their HRQoL and symptoms.~   "
55191|NCT02844595|"~     The number of people who smoke, have concurrent depression and that seek treatment for~     smoking cessation has increased in recent years. This implies the need to design intensive~     and specific interventions that target this issue. In depression treatment, behavioural~     activation is one of the psychological interventions whose characteristics of brevity,~     flexibility and efficiency make it an ideal candidate to be included as part of smoking~     cessation treatment, especially when smokers have depressive symptoms. The aims of the~     present trial are: 1) to assess the efficacy (abstinence rates) of a psychological smoking~     cessation treatment with elements from behavioural activation for managing depressed mood (a~     randomized control trial with three groups: standard cognitive-behavioural smoking cessation~     treatment, standard cognitive-behavioural smoking cessation treatment plus behavioural~     activation, and a control group of delayed treatment) at the end of treatment, and at 3-, 6-,~     and 12-months follow-ups; and 2) to assess whether the applied cognitive-behavioural smoking~     cessation treatment plus behavioural activation improves depressed mood at the end of~     treatment and 3-, 6, 12-months follow-ups.~   "
55192|NCT02844582|"~     This phase II trial studies how well cabazitaxel and prednisone work in treating patients~     with hormone-resistant prostate cancer that has spread to other parts of the body. Drugs used~     in chemotherapy, such as cabazitaxel and prednisone, work in different ways to stop the~     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading.~   "
55193|NCT02844569|"~     This study will be a randomized clinical trial involving a total of 24 subjects. The~     investigators propose to recruit subjects into 2 groups: 1) Extraction treated with xenograft~     bone substitute (BioOss Collagen®) + collagen dressing (HeliPlug®), 2) Extraction treated~     with xenograft bone substitute (BioOss Collagen®) + 3D-collagen matrix (Mucograft Seal®). All~     subjects recruited will have already been approved and treatment planned for extraction +~     implant placement by non-study personnel to avoid any potential conflict of interest. All~     subjects will have radiographs that show the tooth planned for extraction. Each subject will~     be eligible for only 1 tooth extraction + dental implant rehabilitation. After tooth~     extraction, subjects will receive a standard site preservation therapy consisted with~     xenograft bone substitute + collagen dressing or the alternative site preservation therapy~     consisted with xenograft bone substitute + 3D-collagen matrix. After the conventional 6-month~     healing period, subjects will receive a dental implant in the previous extracted site. During~     the dental implant procedure, a 2x5mm bone core biopsy + a 2mm gingival biopsy will be~     obtained from the implant site. Biopsy samples will be stored for future histological and~     histochemical analysis. After dental implant placement, all subjects will receive a healing~     abutment for soft tissue healing prior to implant restoration.~      During the 6-month healing time after tooth extraction and site preservation therapy,~     subjects will return at week-1, week-2, week-4, month-3, and month-6 for intra-oral scanning~     for soft tissue volumetric acquirement. Subjects will receive a Cone beam computed tomography~     (CBCT) prior to extraction for the baseline hard-tissue volume measurement and appropriate~     extraction planning and at 6-month post-extraction for volumetric measurement and appropriate~     implant treatment planning.~      Hard tissue analysis will be performed to compare linear ridge remodeling (baseline vs.~     6-month healing). CBCT images will be analyzed by non-contact reverse engineering system.~     Soft tissue volumetric analysis will be performed to compare the soft tissue healing between~     BioOss Collagen + Mucograft Seal and BioOss Collagen + Collagen Dressing. Images captured~     with an intra-oral scanner collected at baseline, week-1, -2, -4, month-3, and month-6.~   "
55194|NCT02844556|"~     The purpose of this study is to carry out an international multicenter trial to get more~     convincing and valuable results of the SMILE surgery and compare the outcomes between the~     SMILE surgery and the FS-LASIK (femtosecond laser assisted-laser in situ keratomileusis)~     surgery.~      The investigators hope to investigate the differences between the SMILE and the FS-LASIK~     surgery comprehensively, including the comparison of visual acuity, refraction, the~     correction of cylindrical diopter, the high order aberrations, the corneal biomechanics, the~     corneal ectasia, the characteristics of the changes of central corneal thickness and the~     complications. To meet the demands of a multi center trial, all the examination equipments~     should be same in each center, and this will limit the variations within a study~   "
55195|NCT02844543|"~     This study will assess the effects of exercise and non-concussive bodily contact on~     eye-tracking scores collected by the EYE-SYNC eye-tracking device.~   "
55196|NCT02844530|"~     The investigators propose a randomized phase 2 study evaluating 90Y-epratuzumab tetraxetan~     for relapsed/refractory CD22+ B-ALL adult patients using the recommended activity of 370~     MBq/m² x 2. in order to confirm the investigators' previous results. The cut-off of 70% for~     the expression of CD22 has been chosen in order to propose this protocol to all adults with~     CD22+ B ALL in relapse or with refractory disease. Indeed, median expression of CD22 is~     almost 100% in this setting but some patients are documented between 70 and 100%. RIT will be~     assessed in comparison with standard of care salvage chemotherapy regimens. Only three~     standard salvage chemotherapy regimens will be permitted in order to avoid too much bias for~     the comparative analysis of clinical efficacy.~   "
55197|NCT02844517|"~     The objective of the study is for clinical staff to gain experience using the proposed~     artificial pancreas system named inControl and the inControl Cloud and assess 24/7 in-home~     usability prior to initiating a large randomized controlled trial.~   "
55198|NCT02844504|"~     Breast cancer patients often suffer from long-term physical symptoms of weakness. In this~     study, investigators propose to compare how two different low intensity physical exercise~     training programs can improve handgrip strength for breast cancer patients with symptoms of~     weakness. Using brain imaging, the study will also investigate changes in brain structure,~     and muscle activity associated with handgrip.~   "
55201|NCT02844465|"~     The study is designed to evaluate the safety and efficacy of the Visualase MRI-guided laser~     ablation system for mesial temporal epilepsy (MTLE).~   "
55298|NCT02843191|"~     This trial is to assess the efficacy and feasibility of consolidation chemotherapy after~     neoadjuvant chemoradiotherapy for locally advanced mid or low rectal cancer.~   "
83899|NCT02468817|"~     Exercise that causes a decline in serum Calcium (Ca) as a result of dermal Ca loss stimulates~     bone resorption via an increase in Parathyroid Hormone (PTH).~   "
55202|NCT02844452|"~     Introduction: Atopic dermatitis (AD) is a chronic relapsing inflammatory skin disease~     inducing poor quality of life. Its conventional treatments often cause unsatisfactory relief~     and adverse effects in long-term application. Acupuncture treatment is regarded to have a~     curative effect on AD symptoms. The aim of this trial is to evaluate the therapeutic effects~     of acupuncture on AD symptoms including pruritus and poor quality of life in patients with~     AD.~      Method and Analysis: This trial is a randomized, sham-controlled pilot trial with different~     visit frequencies. 30 eligible patients with atopic dermatitis will be randomly allocated in~     a ratio of 1:1:1 to the Verum Acupuncture group 1 (VA1, 3 days weekly), Verum Acupuncture~     group 2 (VA2, 2 days weekly) and Sham Acupuncture group (2 days weekly). The acupuncture~     treatment will be given three or two times a week for 4 weeks according to the allocated~     groups. The main outcome measures are Visual analogue scale for itch (itch VAS), SCORing~     Atopic Dermatitis (SCORAD) and Eczema Area and Severity Index (EASI) to evaluate the~     improvement of AD symptoms and Patient Oriented Eczema Measure (POEM), Dermatology Life~     Quality Index (DLQI) to assess the quality of life of AD patients. It will be measured at~     baseline, once a week during treatment period and after follow-up period.~      Ethics/Dissemination: This protocol was approved by the Institutional Review Boards at Kyung~     Hee University Korean Medicine Hospital on May 2016. The permission number is~     KOMCIRB-160212-HRBR-004. This trial will provide the data of therapeutic effects of treating~     atopic dermatitis with acupuncture in accordance with the different visit frequencies. The~     outcomes will be facilitated to calculate the sample size of further study with the same~     design of this study. The findings from this trial will be published and presented in~     conference.~   "
55203|NCT02844439|"~     This is a multicenter, Phase 2 study to assess the activity of tesevatinib in patients with~     recurrent glioblastoma.~   "
55204|NCT02844426|"~     To evaluate the efficacy of synbiotic (BIFICOPEC) containing Enterococci, Bifidobacteria,~     Lactobacilli triple viable bacteria and pectin in patients with slow transit constipation.~   "
55205|NCT02844413|"~     Regular exercise is recommended as an adjuvant treatment in hypertensive subjects by both~     European and American guidelines. Crucially, however, there are no precise recommendations on~     the type of physical exercise and how it should be instituted A relatively short period (5~     months) of regular aerobic interval training (AIT), significantly decreased blood pressure,~     pulse wave velocity, and most applanation tonometry indexes in hypertensive subjects also~     undertaking pharmacological treatment in our study.~   "
55206|NCT02844400|"~     The primary objective of this study is to establish the feasibility and value of physical~     fitness assessment within patients receiving cytotoxic chemotherapy. If successful, this~     project will establish the groundwork for physical function assessment in larger cancer~     clinical trials to assist patient selection and evaluation of toxicity and/or response among~     trial participants.~   "
55207|NCT02844387|"~     This study evaluates the nutritional supplement arginine as supportive measure for patients~     with unresectable metastatic brain tumors that receive radiation therapy with palliative~     intent~   "
55208|NCT02844374|"~     Epilepsy is a devastating chronic disease due to multiple causes that affect close to 50% of~     the world's population.~      Although effective, epilepsy surgery fails in many cases, the percentage of patients free~     from crisis on a long term (≥ 5 years) varies from 27% to 66% according to the kind of~     epilepsy.~      It is in this context that EPISTIM is interesting, and its aims isb a better~     electrophysiology delimiting of cortical networks that imply the genesis of seizures with the~     aim to improove surgery results.~      This study will rely on the intracerebral records and on corticales electrical stimulation as~     they are currently routinely used by epileptic patients candidates for surgery.~   "
55209|NCT02844361|"~     The purpose of this study is to evaluate whether autologous stem cell transplantation will~     improve the survival of patients with high-risk Waldenström macroglobulinemia, compared with~     conventional chemotherapy.~   "
55210|NCT02844348|"~     A chronic renal disease can results in the development of cardiovascular complications,~     including chronic arterial disease ; but a cardiovascular disease may be from a kidney~     malfunction that will end in end stage renal disease (ESRD). Two thirds of the chronic~     hemodialysis patients taken in charge in Grenoble in the last years suffered from an arterial~     disease at a symptomatic stage. Breakthrough pain can appear during the hemodialysis~     sessions. These sessions induce sudden hemodynamic changes and a peripheral vasoconstriction~     reaction that increases in particular all pain phenomena related to chronic low limbs~     ischemia. Therefore, patients have to face pain, sometimes chronic but also breakthrough~     pain, during the dialysis sessions, in all its dimensions.~      The analgesic balance through the classical drug treatment is extremely complex, as they are~     both at risk of overdose and of partial effectiveness. Strict medical treatment remains~     unsatisfactory, as it takes into account only the expressions of symptoms during dialysis~     sessions, when most of the time pain is already installed and analgesic treatment is not~     completely effective.~      The combination of classic pharmacological treatment with hypnosis, already used in other~     indications (chronic pain, analgesia, depression and anxiety), may mitigate the painful~     feeling on patients suffering from arterial disease during the dialysis sessions, with a~     beneficial impact on their overall quality of life. There is also evidence to suggest that~     hypnosis may be more effective treating neuropathic or vascular pain, those experienced by~     our patients, than musculoskeletal pain, like back pain.~      Hypnosis is a mind-body approach focused on the subject, and not on the disease or the act of~     dialysis. It can be described at the same time as a modified state of consciousness and a~     particular intersubjective relation between a practitioner and his patient. The practice of~     this kind of hypnoanalgesia by the nurses is particularly relevant in hemodialysis, as the~     trust developed during regular chronic treatment can become an asset to shorten the induction~     phase and help to install this intersubjective relation.~      The high incidence of this complication, the difficulties of current pain management and the~     impact on everyday life for the patients, justify the choice of this approach, where more~     further research is needed.~   "
55211|NCT02844335|"~     The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to~     advanced breast cancer.~   "
55212|NCT02844322|"~     The purpose of this study is to compare the efficacy of cyclophosphamide plus dexamethasone~     combined with rituximab or bortezomib regimens in newly diagnosed Waldenström~     macroglobulinemia patients.~   "
55213|NCT02844309|"~     The purpose of this study is to evaluate the efficiency of an oral regimen in newly diagnosed~     Waldenström macroglobulinemia: thalidomide plus cyclophosphamide and dexamethasone following~     by thalidomide and prednisone maintenance therapy.~   "
55235|NCT02844023|"~     Giant cells arteritis or Horton disease is a vasculitis that affects great vessels. This is~     the most frequent vasculitis of the population over the age of 50. This vasculitis is at the~     origin of an inflammatory infiltrate of arterial tunics, essentially composed of lymphocytes.~     Clinical signs are a deterioration of general state, unusual cephalgias, jaw pain, scalp~     hyperesthesia, but can also be serious ischemic complication, especially ophthalmologic with~     the possibility to go blind. Until now, the standard treatment is a high dosage~     corticosteroid therapy.~      Diagnosis is based on criterias of the American College of Rheumatology, dating back to 1990.~     The relapse rate is important, ranging from 10 to 64 % according to studies. There are also~     issues of becoming dependent on steroid.~      So it is important to determine new diagnosis markers and a therapeutic following of giant~     cells arteritis.~      With this study several biomarkers of inflammation will be studied in order to determine if~     one ore many of them have a good sensitivity and special feature for diagnosis and following~     of giant cells arteritis.~      The main goal is to determine a new diagnosis marker for giant cells arteritis.~   "
55214|NCT02844296|"~     Smoking is highly addictive and quitting is difficult. Relapse is common because of~     withdrawal symptoms such as craving, headache, mood change and irritation. In addition to~     pharmacotherapy, exercise can acutely reduce craving, withdrawal symptoms and negative affect~     in regular smokers. Exercise effectively reduces negative affect and attentional bias towards~     smoking, and hence might relieve craving.Instead of long duration (30+ minutes) exercise,~     short-bout exercise is more easily adhered to in daily living and achieves similar health~     gain as long-bout exercise.Handgrip, which enhances training of hand-griping strength, is a~     common short-bout exercise tool used for lowering blood and arterial pressure.Therefore, this~     exercise tool might also raise smokers' interest to initiate this simple and effective~     exercise for quit attempt.~      This RCT study was proposed by using short-bout exercise (intervention) and healthy diet~     (control ) for smoking cessation, targeting adult clients who enrolled in smoking cessation~     service of ICSC, smoke 10 cigarettes or more a day when they initially receive the treatment~     from ICSC, can access to Internet by using smart phone and interested in participating in an~     exercise/diet program for smoking cessation. All the participants will be randomized the~     subjects to one of the RCT groups by using sequentially numbered, opaque sealed envelope~     method. Participants from both groups will be helped to install a phone application (App) in~     their smartphone which can send reminders of doing exercise or healthy diet. Also, the~     participants will enter their smoking and craving data by the App by answering the automatic~     pooped daily questionnaire. Telephone follow-up will be conducted at 2,6 and 12 months.~   "
55215|NCT02844283|"~     This will be the first clinical trial use Ad-HGF gene for the treatment of myocardial~     infarction disease.~   "
55216|NCT02844270|"~     The Galaxy First-in-man study is a small pilot. single arm research , which will enroll a~     total of 45 patients. The goal is to access the feasibility, safety and efficacy of Rapamycin~     Drug-Eluting Bioresorbable Coronary Stent System in the treatment of patients with de novo~     coronary lesion.~   "
55217|NCT02844257|"~     Acute myeloid leukaemia (AML) is a haematological malignant disease characterized by an~     uncontrolled proliferation of immature hematopoietic cells. Over the last two decades,~     clinical trials have demonstrated an improved response rate in younger adult AML. Aggressive~     induction plus more potent intensification programs with chemotherapy alone or chemotherapy~     plus stem cell transplantation (SCT) has improved treatment results. Advances in~     understanding disease biology, improvements in induction and consolidation program, and~     better supportive care have also all contributed. A number of clinical and laboratory~     characteristics influence the response to treatment and, thus, the survival of patients with~     AML. Among them, cytogenetic at diagnosis represents the most important prognostic variable.~     However, other factors may have a prognostic value and may influence patient's outcome.~      Anaemia and thrombocytopenia are cardinal manifestations of AML. Over the last decades, it~     has become apparent that the frequency of allogeneic blood transfusions can modify host~     immunity and clinical outcomes. Anaemia has long been recognized as an adverse prognostic~     factor in myelodysplastic syndrome (MDS), which represents a pre-leukemic disease. Red blood~     cell (RBC) transfusion need was identified as a strong and independent risk factor for~     survival in MDS, for which the presence and severity of anaemia were attributed to a clonally~     advanced and biologically more aggressive disease.~      Based on these data, the investigators retrospectively assessed the prognostic value of RBC~     and platelet transfusions at the time of diagnosis and the frequency of transfusions during~     the first induction course of chemotherapy in a large unselected group of patients with~     previously untreated AML.~   "
55218|NCT02844244|"~     To strengthen family well-being and neighborhood cohesion in Kwun Tong community, a community~     -based Learning families campaign was conducted. As an initial step of this project, the~     investigators conducted a need assessments before designing and conducting a~     train-the-trainer workshop.The train-the-trainer workshop aimed to prepare the members of~     Estate Management Advisory Committees (EMAC) and Mutual Aid Committees (MACs) to implement~     and assist in conducting a series of community-based family well-being activities for~     residents in a public housing estate. Focus group interviews (before and one year after~     training workshop) were conducted to obtain opinion from the members of EMAC and MACs of the~     public housing estate. Questionnaire assessments were conducted before, immediately after~     finishing the training workshop, one year after training workshop.~   "
55219|NCT02844231|"~     Sleepwalking (also called somnambulism) is a disorder in which only SWS is disrupted. This~     NREM parasomnia is characterized by inappropriate motor behaviors, usually initiated during~     arousal from SWS, that induce psychological distress and alter quality of life, leading to~     fatigue, excessive daytime sleepiness, and objectively impaired vigilance in the morning.~      The pathophysiology of sleepwalking remains poorly understood. Sleepwalkers had difficulty~     maintaining stable, consolidated sleep and experienced more arousals and microarousals,~     specifically from SWS, leading to increased NREM instability, especially during the first~     sleep cycles. The brain is partially awake, resulting in behavioral manifestations, and~     partially in NREM sleep, resulting in no conscious awareness of actions.~      A Single Photonic Emission Computed Tomography (SPECT) study of one sleepwalking episode~     found increased activation in the posterior cingulate cortex and cerebellum, with~     deactivation in the frontoparietal associative cortices. Data from intracerebral EEGs during~     confusional arousals confirmed both local arousal of the motor and cingulate cortices and~     increased delta activity in the frontoparietal associative cortices.~      The investigators thus proposed a controlled study of SPECT imagery in 24 sleepwalkers (12~     SPECT during a SW episode and 12 SPECT during slow wave sleep and 24 during wakefulness) and~     12 controls (during slow wave sleep and wakefulness). SW episodes will be elicited by sleep~     deprivation condition associated with forced arousal (auditory stimulus).~      The comparative analyses of SPECT acquisitions between different states (wakefulness, slow~     wave sleep and SW) and populations (sleepwalkers versus controls) will provide new insights~     about the complex pathophysiology of SW episodes.~   "
55236|NCT02844010|"~     This study is based on the change in weight of hospitalized patients knowing that the~     diagnosis of malnutrition based on the presence of at least one clinical or laboratory test~     which anthropometric measures (Evaluation of diagnostic protein energy malnutrition in~     hospitalized adults ANAES , Guidelines Department, September 2003; HAS Strategy supported in~     cases of wasting energy and protein in the elderly April 2007).~      The goal of this study is to find the correlation between hospitalization and weight loss,~     significant risk factors for malnutrition in a situation of community-acquired pneumonia~     infection.~   "
55220|NCT02844218|"~     Patients aged ≥70 years with acute myeloid leukemia (AML) have a poorer prognosis than those~     aged 60 to 69 years. The poor outcome is the result of treatment-related toxicity in elderly~     patients, owing to comorbidities, the greater possibility of other hematopoietic disorders,~     and a biologically poor risk prognosis. Anthracycline- and cytarabine-based therapy,~     administered for 3 and 7 days respectively (3 +7), remains the standard induction therapy for~     this patient population. This approach improved survival compared with supportive care~     (median, 5 vs. 3 months) for adults aged ≥ 65 years. However, the overall view has been that~     the results of intensive chemotherapy in elderly patients remain poor. Although complete~     remission (CR) rates of 40% to 80% can be achieved in highly selected populations, long-term~     survival has been poor. Furthermore, most clinical trials have only enrolled patients with an~     adequate performance status (PS).~      Prognostic models have been developed from clinical trial data to predict the outcomes for~     older patients. However; each model relies on chronologic age. Age is a surrogate measure for~     both changes in tumor biology and patient characteristics. Understanding which patients are~     likely to benefit from intensive therapies versus low-intensity therapies or supportive care~     is critical. The definition of fit to undergo intensive induction therapy has not been~     established, and the therapeutic choice is mainly determined by physician and patient~     decision. In older patients, low-dose cytarabine (LD-AraC) has been demonstrated to be more~     beneficial than best supportive care and hydroxyurea. The recent availability of new drugs~     that could have an improved side effect profile and, in some cases, bioavailability might~     offer future improvement for this patient population. In this setting, the investigators have~     tended to consider, since 2007, patients aged ≥70 years as potential candidates for~     alternative lower intensity therapy (LD-AraC, hypomethylating agents) even when they~     presented in good physical condition.~      The investigators goal was to determine whether age ≥ 70 years could represent a useful and~     simple cut off for treatment decision-making in clinical practice and whether low-intensity~     therapy could be an alternative therapeutic approach to intensive chemotherapy even for~     patients aged ≥ 70 years who were theoretically fit (WHO /ECOG/ PS of ≤ 2).~   "
55221|NCT02844205|"~     Neonatal intensive care is necessary for the survival of preterm baby. Several studies show~     the deleterious effect on the immature brain due to stimulations caused by the environment~     and hospital care.~      However, a specific and individualized support to the development during the first weeks of~     this preterm patient has a positive effect on newborn development.~      A new practical newborn behavioral observation scale has been developed by the investigators~     care unit in order to adapt care and individualized support to the development for each~     patient.~      The goal of this study is to estimate the external reproductibility of this scale by~     experimented nurse in order to implement an individualized care program.~   "
55222|NCT02844192|"~     Vancomycin is frequently under-dosed in ICU patients during the first 24-48 hours of~     treatment. Glomerular hyperfiltration syndrome, increased drug volume of distribution,~     vasopressor use, male sex and hypoalbuminemia are identified risk factor for vancomycin~     underdosing in ICU patients, among others.~      To date, bedside estimation of vancomycin volume of distribution is challenging, and new~     methods for optimizing drug administration are required.~      The Picco device is a moderately invasive hemodynamic monitoring system, providing parameters~     that may help estimation of vancomycin pharmacokinetics parameter.~      The aim of this study is to test whether addition of hemodynamic parameters would improve~     pharmacokinetics modelling of vancomycin concentration in ICU patients.~   "
55223|NCT02844179|"~     This research study is intended to determine the initial safety and tolerability of single~     oral doses of the drug (+)-alpha-dihydrotetrabenaxine (HTBZ) in normal volunteers. HTBZ is~     believed to be the active ingredient in the FDA-approved drug tetrabenazine (TBZ, brand name~     Xenazine), prescribed for treatment of involuntary movements in patients with Huntington's~     chorea. TBZ is a mixture of closely-related compounds (isomers) and is readily metabolized~     (converted) in the human body to HTBZ and related isomers. Investigators believe that HTBZ,~     the drug to be studied in this research, is the active ingredient in TBZ. The present study~     will confirm safety and tolerability of HTBZ and will investigate its expected effects on~     brain sites that are the target of TBZ therapy.~   "
55224|NCT02844166|"~     The presence of pressure injuries has been considered a quality indicator of health care~     services and efforts has been made to develop guidelines to prevent this issue. Intensive~     care unit admissions (ICU) are recognized as risk factors to develop pressure injuries due to~     reduced mobility of critically ill patients and large number of devices and hard technologies~     that jeopardize preventive measures, such as, decubitus changes. There are not current~     definitive evidence about the superiority of any support surface to treat or prevent pressure~     injuries. The objective of the present study is to analyze if the use of viscoelastic support~     surface in vulnerable critically ill patients decreases the incidence of pressure injury~     compared with pyramidal foam support surface.~      Randomized clinical trial performed in an intensive care unit for adult patients in a~     philanthropic hospital. Inclusion criteria are patients admitted to ICU with Braden scale ≤~     14. Exclusion criteria are age under 18 years, less than 24 hours of ICU length of stay,~     contraindication of performing complete institutional preventive measures for support~     injuries, presence of support injuries at ICU admission or absence of informed consent.~     Randomization will be made by computerized generated numbers and patients will be allocated~     in two groups in a ratio of 1:1. All study patients will be cared for according to standard~     institutional preventive measures. The interventional group will be placed in an ICU bed with~     viscoelastic support surface and the control group in an ICU bed with pyramidal foam support~     surface. The main outcome evaluated will be the occurrence of type II pressure injury.~     Secondary outcomes are the time to the occurrence of pressure injury, length of ICU and~     hospital stay and 28 days mortality rate. Significance level will be 5%.~   "
55225|NCT02844153|"~     Metformin is the most widely prescribed oral treatment for diabetes, and the only one that~     showed a survival benefit.~      Yet, there is no consensus on the optimal dose and withdrawal of metformin in chronic kidney~     disease (CKD) patients.~      The aim of the study is to describe the use and side-effects of metformin in CKD patients in~     routine practice.~   "
55226|NCT02844140|"~     Dose distribution calculations for proton therapy are more accurate when based on DE-CT than~     on SE-CT. It is however unclear what the quantitative benefit of repeated DE-CT calculations~     is for lung cancer patients.~   "
55227|NCT02844127|"~     The purpose of this study is to determine how the position of the right ventricular (RV) coil~     of an implantable cardioverter defibrillator (apex versus septum) affects the defibrillation~     threshold; specifically, can defibrillator threshold be improved by implantation site~     selection.~   "
55237|NCT02843997|"~     Bipolar disorder is a chronic and frequent mood pathology, that impacts on emotional and~     socio-professional life of sick subjects, and also increase mortality by suicide. Suicide is~     considered as a bipolar disorder result.~      The main goal of this study is the endophenotype characterization from a clinical and~     cognitive point of view, of a bipolar spectrum's disorder present in a family, and then~     highlight a mutation of one of the genes involved is this disorder.~   "
55228|NCT02844114|"~     This study evaluates the effect of the serum level of Superoxide Dismutase (SOD),~     Malondialdehyde (MDA), pro-inflammatory factors, stress hormones and Glutathione peroxidase~     (GSH-PX)in tumor patients with the treatment of Ganoderma lucidum spore based combination~     chemotherapy. Half of participants will receive Ganoderma lucidum spore and chemotherapy in~     combination, and the other half will receive a placebo and chemotherapy.~      Study design: Phase 2. Experimental: Ganoderma lucidum spore & Chemotherapy; Placebo~     Comparator: Placebo & Chemotherapy.~      Outcome Measure:~        1. The life quality of participants was assessed with use of the Functional Assessment of~          Cancer Therapy-General (FACT-G) questionnaire at the initial diagnosis (baseline) and at~          42 days after the treatment;~        2. Investigators assessed Procedural mortality factor ligand 1(PD-L1)expression~          prospectively on tumour cells and tumour-infiltrating immune cells with the VENTANA~          PD-L1 immunohistochemistry assay;~        3. National Cancer Institute Common Toxicity Criteria.~      Statistical analysis: All experiment results were analyzed with Statistical Product and~     Service Solutions (SPSS) software (version 16.0). Data are presented as mean±standard~     deviation and analysed by one-way ANOVA. Semi-quantitative data were compared using the~     Kruskal- Wallis nonparametric analysis. The results were considered statistically significant~     at P<0.05.~   "
55229|NCT02844101|"~     Eighty healthy youngsters, aged 10-18 years, will be equally randomized between the blinded~     and the non-blinded group. The blinded subjects will be informed that we were testing the~     reliability of a new device for body posture assessment and these youngsters will did not~     receive any information with regards to physical activity. Conversely, the non-blinded~     subjects were informed that the device was an accelerometer that assessed physical activity~     levels and patterns. Participants will be instructed to wear the accelerometer for 4~     consecutive days and to keep a non-wear log diary over the 4 day-monitoring. The overall~     duration and the duration relative to the quality of the physical activity patterns~     (sedentary, light, moderate, vigorous and moderate to vigorous) were computed for each group~     during the 4-day monitoring, then compared between the two groups using the Student's t test.~   "
55230|NCT02844088|"~     Meningococcus C vaccine was first used in France to prevent epidemics. It was a success in~     Puy-de-Dôme, Landes, Pyrénées Atlantiques and Hautes Pyrénées. Following many European~     countries, France introduced meningococcus C conjugate vaccine in 2009 but this~     recommendation was not suffiicently applied (6,6% of the 20-25 years-old were vaccinated in~     2015).~      The situation in France is very different from UK and there is no data on the subject. The~     vaccination campaign in 2002 in Puy-de-Dôme offers much more detachment, possible comparison~     between vaccinated and unvaccinated people, among which meningococcus circulation could~     maintain immunity. This is the reason why we have decided to assess in 2016 the vaccinal and~     natural immunity among Puy-de-Dôme population.~   "
55231|NCT02844075|"~     In this study, participants with esophageal squamous cell carcinoma will receive preoperative~     chemoradiotherapy with paclitaxel,carboplatin and pembrolizumab then undergo surgery. The~     primary study hypothesis is that adding pembrolizumab will increase complete pathologic~     response rate at surgery.~   "
55232|NCT02844062|"~     Chimeric antigen receptor (CAR)-modified T cells can mediate long-term durable remissions in~     recurrent or refractory CD19+ B cell malignancies, and are a promising therapy to treat~     glioblastoma, which is the most dangerous and aggressive form of brain cancer. EGFRvIII~     mutation (epidermal growth factor receptor variant III, EGFRvIII) is the results of tumor~     specific gene rearrangement naturally happened in about 30% of glioblastoma patients and~     produces a mutated protein with neo-antigen that is tumor specific and is not expressed in~     normal human tissues. Therefore, EGFRvIII is an attractive target for CAR T cell therapy. We~     have constructed a lentiviral vector that contains a chimeric antigen receptor that~     recognizes the EGFRvIII tumor antigen. A truncated EGFR (tEGFR) which lacks of the ligand~     binding domain and cytoplasmic kinase domain of wildtype EGFR is incorporated into the CAR~     vector and is used for in vivo tracking and ablation of CAR T cells in necessary. This pilot~     study is to determine the safety and efficacy of autologous anti-EGFRvIII CAR T cells in~     patients with recurrent glioblastoma.~   "
55233|NCT02844049|"~     Obsessive-Compulsive Disorder (OCD) is among the most disabling psychiatric disorders as more~     than 40% of patients are resistant to the standard pharmacological and psychotherapy~     approaches and about 10% show severe disability and require institutionalization. These~     resistant patients may benefit from new surgical therapeutic approaches such as Deep Brain~     Stimulation (DBS) using high frequency stimulation of specific cerebral regions to modulate~     neural networks. Although promising, these results need nevertheless to be replicated and~     confirmed within a larger cohort of patients and considering a different main objective,~     instead of clinical improvement only. Indeed, despite a positive treatment response, adaptive~     functioning and quality of life may continue to be negatively impacted in OCD. Thus beyond~     symptom reduction, health-related quality of life (QoL) represents a more important objective~     of a treatment, as it includes both the individual's functional status and the individual's~     subjective perception of the impact of the illness on the patient's life. STN DBS induces~     significant clinical improvement, which may not be proportional to the QoL gain.~     Consequently, QoL appears to be a better outcome to target in the coming studies than~     clinical improvement alone. THe investigators thus propose a prospective study assessing the~     QoL changes of resistant OCD patients under STN DBS+BMT versus Best Medical Treatment (BMT)~     at 12 months, in order to assess the DBS induced gain in QoL in BMT-managed patients versus~     BMT alone.~   "
55234|NCT02844036|"~     Currently, the standard treatment for proximal thromboses lesions responsible for~     post-embolic pulmonary hypertension, is the surgical thromboendarterectomy. When the ravages~     are judged too distal or the patient is judged inoperable for a curative surgical gesture,~     there is no evidence of any therapeutic option, exept for K anti-vitamins for recurrent~     embolism. Prognosis is then pejorative with a 60% mortality at 5 years.~      This study propose an alternative treatment for these patients in therapeutic dead end.~     This is about applying arterial thrombosis technique to the pulmonary circulation.~   "
55238|NCT02843984|"~     Objective: To evaluate the influence of vaginal Lactoferrin administration on amniotic fluid~     concentration of 47 cytokines, chemokines and growth factors.~   "
55239|NCT02843971|"~     Monocentric, prospective study, comparison of the water drinking test response in the supine~     and in the sitting position using the intraocular pressure monitoring device Sensimed~     Triggerfish in healthy subjects.~   "
55240|NCT02843958|"~     This clinical trial is about a new technology, named HEMOPTIC. It enables to mesure time of~     blood coagulation for monitoring of patients under Vitamin K antagonist (VKA).~      This device was created as an alternative to blood sample, that have to be done in a medical~     laboratory.~      The main goal is to evaluate the accuracy of the International Normalized Ratio (INR)~     measurement of this new portable device for diagnostic in vitro, among healthy patients and~     patients under anti-vitamin K treatment.~   "
55241|NCT02843945|"~     Initial study to evaluate local control and the preferred method of attachment of the~     CivaSheet in the setting of suspected close or positive margins at the time of surgical tumor~     removal.~   "
55242|NCT02843932|"~     The aim of this study is to reveal neurobiological bases of the motor control of conscious~     perception, thanks to new techniques of functional cerebral imaging (MRI), and potentials~     deteriorations connected to neuropsychiatric disorders like conversion disorder.~      The Hospital University Center of Grenoble will provide patients from Neurology department,~     characterized with non psychogenic epileptic seizures and abnormal psychogenic movements,~     from conversive origin.~      Subjects will be scanned by Magnetic Resonance Imaging during a motor paradigm inducing a~     perceptive conflict between two informations : proprioceptive information coming from the~     action (drawing) and visual information (draw's mark) that appears on the screen when there~     is movement.~   "
55243|NCT02843919|"~     The goal is to identify neuro-physiological signatures at several levels of mental workload~     during the realisation of tasks, performed by all the subjects.~      In parallel, there will be a methodological work consisting to develop the classification~     algorithms, predictives of these levels of mental workload in real time, in purpose to~     implement a passive brain-machine interface in the best interest of operators that accomplish~     complex tasks.~      Mesures of electro-physiological activity will be recorded in order to approve states of~     charge in addition to behavioral performances.~   "
55244|NCT02843906|"~     The purpose of this study is to identify association between cerebrospinal fluid Alzheimer's~     Disease's neurodegenerescence biomarkers (tau, ptau, Aß40 and Aß1-42) and occurrence of~     cognitive deficits in older patients with bipolar disorders.~   "
55245|NCT02843893|"~     Sedation-analgesia is an important therapy for patients in resuscitation. It requires a~     surveillance, in order to avoid excessive or insufficient dosages of sedative or~     nonmorphinics, sources of side effects. Yet, means of surveillance are limited in~     resuscitation care : variations of blood pressure and heart rate are not very sensitive~     criterias. Clinical scales to measure the sedation and analgesia level were proposed for~     patients in resuscitation, including the Richmond (RASS) sedation scale and the behavioural~     pain scale (BPS). The study of pupillary dilatation's reflex (RDP) due to a nociceptive~     stimulation is a tool proposed for the monitoring of the analgesia peroperative for patients~     under general anaesthetic. Yet, there isn't any study that measured the analgesia threshold~     by pupillometry for patients in resuscitation receiving a sedation-analgesia.~      The main goal of this study is to measure the minimum intensity of a painful stimulation~     (tetanus), leading to a 10% raise of RDP in a cohort of patients in resuscitation care~     receiving sedation-analgesia continuously.~   "
55246|NCT02843880|"~     Cytomegalovirus is a herpesviridae whose prevalence in general population is between 50 to~     80%. In immunocompetent individuals, CMV remains latent in a number of cells, without any~     pathological consequence. Immunosuppression may reactivate the virus causing either a~     CMV-active infection or a CMV disease with attributable symptoms.~      In Intensive Care Unit (ICU), 6 to 30 % of critically ill patients without classical~     immunosuppression, as those suffering from septic shock, present CMV reactivation. Our aim is~     to study the risk factors for developing viremia or CMV disease in ICU patients in septic~     shock without previous immunodepression and determine the relationship between viral~     reactivation and this acquired immunity alteration.~   "
55247|NCT02843867|"~     The incidence of atherosclerotic complications is increased after kidney transplantation.~     Traditional risk factors do not fully explain this increased risk. Atherosclerosis is an~     inflammatory disease in which all players in the immune response are involved. The impact of~     these immune responses is not well known in immunocompromised patients, particularly among~     organ transplant. Nevertheless, the work of our group suggest that innate and acquired~     responses through different mechanisms influencing the evolution of atheromatous disease~     after transplantation.~      The investigators therefore propose to study the impact of the expansion of regulatory T~     cells on the risk of atherosclerotic complications after transplantation.~      Since November 2008, the investigators began a multicenter, prospective study whose purpose~     is to study in detail the immunological mechanisms of atherosclerosis after transplantation~     via immunomonitoring cohort of renal transplant patients in the Grand East Interregion. It~     was planned to include 500 patients and to date a little more than half have been included.~     After completion of the blood test, the tubes are routed over the Biomonitoring Platform~     (CIC-BT 506 Besançon) and the samples are stored in CRB Dijon.~      The atherosclerotic events are recorded prospectively. The investigators hope to implement as~     part of ORLY IS, a second study to determine the impact of an expansion of regulatory T cells~     on the risk of atherosclerotic events.~      Our hypothesis is that a cell rate regulatory T below the median results in an increase of 5%~     of atherosclerotic complications.~   "
55260|NCT02843685|"~     Many health care interventions and medications found to have benefits (efficacy) in~     experimental, tightly-controlled, human research trials are later found to lack real-world~     health benefits (effectiveness). Inadequate surveillance of real-world clinical~     effectiveness may falsely reassure clinicians and those who monitor healthcare quality,~     propagating unrecognized ineffective or harmful treatments at high costs to patients and~     society. The failure to translate potential health benefits into realized gains, or to detect~     unexpected harms in healthcare delivery, stems from a lack of methods with which to robustly~     measure real-world (in)effectiveness. Current methods to detect changes in outcomes 'before~     and after' implementation may be biased by secular trends in healthcare practice and~     outcomes; other methods to compare outcomes for treated and untreated patients may be biased~     by unmeasured factors.~      The current project aims to develop and demonstrate - as a proof-of-concept - the use of a~     quasi-experimental research method called 'regression discontinuity design (RDD)' in~     surveillance of real-world clinical effectiveness. RDD had previously found use in the~     evaluation of educational programs in which students scoring below a threshold were assigned~     an intervention. The US Department of Education considers RDD designs to have quality similar~     to randomized trials.~   "
55248|NCT02843841|"~     The prevention of allograft rejection in kidney transplantation requires administering to the~     patient an immunosuppressive regimen of induction. The induction strategy is based on an~     injection of polyclonal anti-lymphocyte globulin (ATG-FLAG or fresenius®) driving a~     lymphocyte lysis, or an injection of monoclonal antibodies directed against non-lymphopenic~     the α chain of the IL-receptor 2 (anti-CD25 antibody, basiliximab), by immunological risk~     patients. Our group showed a significant increase in death rates in transplant patients with~     lymphopenia CD4 continued beyond 2 years of transplantation. This excess mortality is related~     to complications following chronic inflammation observed in some patients lymphopenic.~      Preliminary studies have shown that the induced lymphodéplétion ATG appears to be accompanied~     by an increase of the bacterial products in the blood of transplanted since a significant~     increase in the sCD14 is observed in these patients one year. We also observed increased~     concentrations of LPS in patients in the ATG group. This could indicate a secondary bacterial~     intestinal translocation to a weakening of intestinal immunity linked to the ATG.~      The main objective of the study is to assess the impact of anti-lymphocyte globulin~     polyclonal on intestinal permeability, estimated by the rate lipopolysaccharide (LPS, a~     constituent of the cell wall of Gram-negative bacteria) blood after kidney transplantation.~      The secondary objectives are to evaluate bacterial translocation, the effect of bacterial~     translocation on structural and metabolic functions of the intestinal epithelium, chronic~     inflammation, immune reconstitution, regeneration, activation and proliferation of T~     lymphocytes, the polymorphism of the LPS receptor that causes the activation of innate~     immunity and the composition of the intestinal microbiota.~      The study population consists of renal transplant patients of Nephrology of the University~     Hospital of Besancon. Patients will be divided into 2 groups according to induction~     immunosuppressive therapy prescribed the day of renal transplantation as part of their usual~     care, ie treatment with anti-lymphocyte globulin polyclonal (ATG-Fresenius®) or antibody~     treatment monoclonal anti-CD25 (basiliximab Simulect). The patient group treated with~     anti-CD25 antibody will serve as a control group (no depletion of the immune system) to the~     group of patients treated with ATG.~   "
55249|NCT02843828|"~     The purpose of this study was to investigate the effects of the new wearable hip assist robot~     developed by Samsung Advanced Institute of Technology (Samsung Electronics Co, Ltd., Korea)~     to gait rehabilitation in elderly adults and stroke patients.~   "
55250|NCT02843815|"~     The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to~     advanced NSCLC.~   "
55251|NCT02843802|"~     The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to~     advanced liver cancer.~   "
55252|NCT02843789|"~     The aim of this study is to analyze the variation of adiponectinemia and its molecular forms~     in RA patients receiving tocilizumab therapy.~   "
55253|NCT02843776|"~     The study epiDESA2 identifies all explicit requests for euthanasia or assisted suicide~     expressed by the person him/herself, regardless of which professional is asked and regardless~     of where the request is made (primary care, health institutions, medico-social institutions~     including nursing home care or at home) in the Burgundy-Franche-Comté region during six~     months.~   "
55254|NCT02843763|"~     As early complications of transplantation (acute rejection and infections) were better~     controlled and that the survival of kidney transplants has increased, chronic complications~     of immunosuppression became increasing challenges. The incidence of cancer is greatly~     increased in transplant and cancer is now the first cause of death. The iatrogenic~     immunosuppression plays a major role in the increased incidence of cancer. If it is accepted~     that the incidence of cancer is generally increased after transplantation, the increased risk~     is very different from a specific cancer to another. Furthermore the specific treatment of~     the tumor (surgery, radiotherapy, chemotherapy, biotherapy), the specificity of the context~     of transplantation is related to the possibility of modulation of immunosuppression. However,~     there is no immunological marker for predicting the effectiveness of a modification of the~     immunosuppression.~      Several studies point to the important role of CD4 T cells into Th1 anti-tumor~     immunosurveillance group cancers. Identified helper degenerate peptides, called Universal~     Cancer Peptide (UCP) derivative of telomerase, a type of tumor antigen universal. These UCP~     peptides bind most HLA-DR alleles most frequent of the population and have the particularity~     of specifically stimulate CD4 T cells of type Th1. Using a test based on the UCP, it possible~     to detect the presence of spontaneous CD4 Th1 anti-UCP answers in several types of human~     cancers.~      The main objective of this study is to determine whether, in renal transplant patients, the~     occurrence of cancer is associated with a deficiency of CD4 Th1 response anti-hTERT.~   "
55255|NCT02843750|"~     To obtain definitive evidence for the effectiveness of a short preoperative inspiratory~     muscle training (IMT) protocol on the morbidity and recovery from an esophageal surgical~     resection.~   "
55256|NCT02843737|"~     The investigators want to validate the Sleep Diversity Index as a diagnosis tool of sleep~     fragmentation on 405 patients who will perform a polysomnography under spontaneous breathing.~   "
55257|NCT02843724|"~     A two year, two arm pragmatic trial to investigate the integration of naturopathic care with~     conventional medical care to provide additional benefit beyond that of conventional medical~     care alone in achieving adequate control of diabetes.~   "
55258|NCT02843711|"~     LUNG-EST is a retrospective study including 152 patients who benefit from lung surgery during~     the years 2012 to 2013 at Hospices civils de Lyon and with a diagnosis of lung~     adenocarcinomas. For all patients, clinical data and histopathological data are available.~     The objective of this study is to characterize these lung adenocarcinomas by the LungCarta~     Panel using the mass spectrometry array Sequenom. This panel could identify 214 DNA mutations~     and/or frameshift insert/deletion among 26 oncogenes. Once included in the study, the~     adenocarcinomas are also included in a Tissue MicroArray (TMA) in order to perform~     immunohistochemical analysis. Immunohistochemical staining with innovative antibodies are~     correlated with clinical, histopathological and molecular data.~      Our hypothesis is that this TMA could constitute a good tool to screen interesting protein's~     expression.~   "
55259|NCT02843698|"~     The study aims to investigate the effect of dexmedetomidine on oxygenation and lung mechanics~     in morbidly obese patients~   "
55281|NCT02843412|"~     Background: Gastric cancer (GC) is major global health concern and the second leading cause~     of cancer deaths worldwide. Amplification of Her2/neu gene and/or overexpression of the~     Her2/neu protein have been observed in GC. Trastuzumab (Herceptin™) is an anti-Her2/neu~     antibody, which has been successfully applied in GC. However, the intratumoral heterogeneity~     of Her2/neu overexpression and amplification in GC should be noticed. The investigators~     investigated the significance of evaluating Her2/neu expression in different paraffin blocks~     of tumor tissue in GC.~      Methods: 2000 GC patients from ten centers, patients were divided into a cohort using one~     tumor tissue paraffin block (cohort 1, n=1000) and a cohort using dual tumor tissue paraffin~     blocks (cohort 2, n=1000) when evaluating Her2/neu expression status by immunohistochemistry~     (IHC). In cohort 2, the investigators combined the results from two different paraffin blocks~     and used the higher one as the final score.~   "
55282|NCT02843399|"~     Primary objective of this study is to compare diabetes-related healthcare utilization and~     costs in patients initiating exenatide once weekly vs insulin glargine.~   "
55261|NCT02843672|"~     INTRODUCTION~      Metatarsalgia is a vague term defining a symptom instead of a specific condition. The aim of~     surgical treatment of metatarsalgia is to decrease the pressure under metatarsal head,~     shortening and / or raising the metatarsal. It has been somewhat controversial, with more~     than 25 different lesser metatarsal osteotomies described to date.~      The Triple´s Weil osteotomy described by Maceira is the most widely used surgical treatment~     in open distal metatarsal surgery but nowadays, percutaneous osteotomy has proven to be a~     valid technique that yields results similar to open osteotomy for the treatment of~     metatarsalgia and other forefoot problems. It has been somewhat controversial the choice~     between the different operative treatments, being nowadays the triple´s Weil osteotomy (TWO)~     and the distal minimally invasive osteotomy (DMMO) the most popular, gaining both defenders~     and retractors surgeons in open and percutaneous surgery.~      The purpose of this study is to compare the clinical results between two different surgical~     treatments: triple´s Weil osteotomy (TWO) and distal minimal invasive osteotomy (DMMO).~      MATERIAL AND METHODS~      The investigators design an open randomized controlled clinical trial with patients operated~     in the same centre.~      The patients are randomized to TWO and DMMO groups. Number of osteotomies is based on the~     criteria of Leventen formula. In all patients the metatarsal osteotomy can be combined with~     different surgical procedures in presence of associated deformities: (i) SCARF osteotomy for~     hallux valgus (HV) deformity, (ii) flexor and extensor tenotomies with distal phalangeal~     percutaneous osteotomy for lesser toes deformities.~   "
55262|NCT02843659|"~     The primary objective of this study is to evaluate the efficacy of treatment with either~     lulizumab or BMS-986142 versus placebo in subjects with moderate to severe primary Sjögren's~     syndrome as measured by the change from baseline in ESSDAI at Week 12 between active~     treatment arms (lulizumab or BMS-986142, respectively) and the placebo arm.~   "
55263|NCT02843646|"~     The purpose of this study is to investigate the use of the WalkAide, a Neuroprosthetic~     device, on a child's ability to ascend/descend stairs and curbs. It is hypothesized that with~     WalkAide use, the improved ankle control achieved, will affect the speed, symmetry, and~     independence of completing the task.~   "
55264|NCT02843633|"~     This study aims to confirm non-inferiority of the BioFreedom™ Drug Coated Stent to the~     Gazelle™ Bare Metal Stent arm of the Leaders Free study in high bleeding risk patients.~   "
55265|NCT02843620|"~     This study evaluates the effects of 40 mg of b-2Cool, a food supplement rich in native~     type-II collagen, on healthy adults with joint discomfort. Half of the participants will~     receive the b-2Cool containing supplement while the other half will receive a placebo pill.~   "
55266|NCT02843607|"~     The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to~     advanced kidney cancer.~   "
55267|NCT02843594|"~     The purpose of this research study is to evaluate the clinical outcomes of different cataract~     surgical techniques for lens fragmentation in subjects undergoing routine cataract surgery.~   "
55268|NCT02843581|"~     The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to~     advanced esophageal cancer.~   "
55269|NCT02843568|"~     The purpose of this study is to develop radiation plans that will help preserve lung function~     in healthy tissue surrounding the tumor. We believe that 4DCT scans can be useful in~     designing radiation treatment plans that help us avoid healthy normal functioning lung tissue~     close to lung tumors. Currently 4DCT scans are used to help us determine exactly where the~     tumor is and how it moves when you breathe. In this study we will also use the 4DCT scans to~     try to identify high functioning normal lung tissue.~   "
55270|NCT02843555|"~     The purpose of this study is to:~        1. define novel homogeneous groups of patients with LDs and~        2. work toward finding the cause of these disorders.~   "
55271|NCT02843542|"~     A comparative prospective study to evaluate different imaging modalities (pet-ct and pet-mr)~     prior to surgery in parathyroid tumor patients.~   "
55272|NCT02843529|"~     The proposed study is designed to evaluate the performance of the ALTOIDA™ System as a tool~     to assist physicians in diagnosing Alzheimer's Disease (AD) in real-world clinical settings.~     The design of this study is guided by two overriding factors: 1) to optimize the performance~     of the ALTOIDA™ neuromotor classifiers, the subjects making up the training sets must be well~     characterized as to their clinical diagnosis, and 2) all ALTOIDA™ tests must be performed and~     reproduced in real-world clinical settings.~      Although there is already a large body of peer-reviewed scientific literature demonstrating~     that certain digital biomarker patterns are associated with certain neurologic conditions,~     the utilization of such tools for the evaluation of neurologic disorders is still considered~     an emerging science and therefore in the investigational stage. Although this protocol will~     report on brain patterns of certain neurologic conditions such as cognitive impairment and~     Alzheimer's disease, based on patterns published in peer-reviewed journals, such findings are~     not considered stand alone or diagnostic per se and should always be considered by the~     primary physician in conjunction with the patient's clinical condition. These data should~     only be used as additional information to add to the primary physician's diagnostic~     impression.~   "
55273|NCT02843516|"~     Implantable Loop Recorders (ILRs), are subcutaneous heart monitors, which are implanted for~     different reasons including syncope (fainting), pre syncope (near fainting), palpitations and~     stroke. They monitor the heart and detect abnormalities.~      Atrial fibrillation (irregular heart rhythm),is a common cardiac arrhythmia associated with a~     five-fold risk of stroke. Atrial Fibrillation increases the risk of stroke in patients to a~     different degree according to a risk stratification score. Anticoagulation is recommended to~     all high-risk patients.~      Recent published studies have shown a high incidence of Atrial Fibrillation detected by ILRs~     in patients with previous stroke.~      It is not known whether a similar incidence of Atrial Fibrillation occurs in patients without~     previous stroke. It is also not know ''how much'' Atrial Fibrillation is necessary to~     increase the risk of stroke, how relevant the finding of Atrial Fibrillation is and whether~     everybody with Atrial Fibrillation should have anticoagulation or whether a bit of Atrial~     Fibrillation is actually normal in most people.~      The purpose of this study is to identify and compare the rate and the burden of Atrial~     Fibrillation (more or less than 30 seconds) in patients with and without previous stroke.~      Medical notes and Implantable Loop Recorder records of the patients that had the devices~     implanted in Addendbrooke's Hospital from March 2009 up to 1 month after the implantation of~     the latest device will be inspected in order to identify whether the device had detected~     Atrial Fibrillation and if so the burden of Atrial Fibrillation in the two different groups~     of patients (with and without previous stroke).~      The risk of stroke for each patient will be calculated. Echocardiographic (ultrasound scan of~     the heart)risk factors for Atrial Fibrillation will be identified and compared between the~     two groups.~      This is going to be a retrospective study and we will be inspecting patients' data only.~   "
55334|NCT02842710|"~     The main objective of this study and to know the incidence of healthy carriers of~     Staphylococcus aureus resistant méti- patients supported for fracture of the proximal femur .~      This assessment will be made preoperatively by a nasal sampling and analysis through it by~     rapid Polymerase Chain Reaction method GeneXpert® .~   "
55274|NCT02843503|"~     Primary objective is to assess the impact of different reference glucose measurement methods~     on the measured performance of a CGM system, aiming at further standardization for the~     assessment of CGM systems. Secondary objective is to describe the relationship between~     glucose concentration of venous, capillary and arterialized-venous measurement samples.~      Study design: Open-label trial. Study population: Nineteen patients with type 1 diabetes aged~     18 years and older will be included.~      Intervention: The study will use the Dexcom G5 Mobile CGM. The participant will visit the~     clinical research center (CRC) twice during a 6 day period. These visits will have a duration~     of 8 hours. Blood will be drawn for the determination of glucose concentrations using venous,~     arterialized-venous and capillary sampling techniques. The patient will receive his usual~     breakfast and an increased insulin bolus will be administered to correct the breakfast~     glucose excursion with the aim of inducing a period of minor hypoglycemia. Blood sampling~     will continue until the end of the admission. The sensor will be worn until the end of the~     second 8-hour CRC session, which will be planned on day 6 or earlier depending on patient~     preference. The sensor will be removed and their sensor and blood glucose meter data~     downloaded from the devices. In the case of sensor failure before the first CRC session,~     patients will be instructed to insert a new sensor per the manufacturer's instruction and to~     notify study staff of the event. In case of failure of the sensor after the first CRC session~     but before the second CRC session, patients will return to the CRC for sensor removal and for~     data download.~   "
55275|NCT02843490|"~     Several studies during the last years reported the involvement of anti-retinal autoantibodies~     in ocular disorders, such as AMD. These studies support the growing evidence of an~     immunological involvement in the pathogenesis of AMD. In the planned trial it is planned to~     enroll 70 subjects, i.e. 50 subjects with neovascular AMD and 20 healthy volunteers. The~     investigators will evaluate the change from Baseline (Visit 1) in BCVA score at Week 12~     (visit 4) in the study eye of nAMD patients treated with Ranibizumab. Neovascular AMD~     patients (group 1) will be accompanied for 6 months and blood samples will be collected at~     baseline and monthly until Visit 7 for analysis of antibody profiles. Healthy volunteers~     (group 2) will be enrolled and a blood sample will be collected once for analysis of antibody~     profiles. Antibody profiles of all study participants will be analysed to address questions~     as defined in the outcome measures.~   "
55276|NCT02843477|"~     It is still challenging to assess intravascular volume status in spontaneously breathing~     patients. Recently, the measurement of corrected flow time in carotid artery was introduced~     as quite useful, simple and noninvasive for the evaluation of circulating blood volume~     change. The aim of this study is to evaluate whether corrected carotid artery flow time as~     determined by ultrasonography can be a predictor of fluid responsiveness in spontaneously~     breathing patients before induction of general anesthesia.~   "
55277|NCT02843464|"~     Patients with acute myocardial infarction (AMI) are in critical condition especially without~     emergency reperfusion therapy. For example, heart failure, heart rupture, malignant~     arrhythmia are in high level. It was reported remote ischemic preconditioning (RIPC) may play~     an effective endogenous cardiac protection. This study will investigate whether long-term~     RIPC can improve the short-term and long-term (1 year) prognosis of AMI patients without~     emergency reperfusion therapy. 220 AMI patients without emergency reperfusion therapy were~     randomly divided into 2 groups: long-term RIPC group (once RIPC/day for a year) or control~     group (routine treatment). Cardiac troponin (TNI), high-sensitivity C-reactive protein~     (hsCRP), adenosine, vascular endothelial growth factor (VEGF), hypoxia inducible factor-1~     (HIF-1), echocardiography and magnetic resonance（MR）were detected in hospital, 1 month and 1~     year after discharge. Patients will be followed up by telephone at the end of one year. The~     major adverse cardiovascular events (MACE) include cardiovascular death, spontaneous~     myocardial infarction, unplanned revascularization and stroke.~   "
55278|NCT02843451|"~     The proposed study will consist of a 9 week double-blind cross-over study trial of milk~     thistle in 15 people (ages 18-65). The study will be divided into an initial 4 week phase, a~     one week wash out phase, and a second 4 week phase, with one of the 4 week phases consisting~     of active treatment with milk thistle, and the other 4 week phase consisting of inactive~     placebo treatment. Participants will be randomized to receive either milk thistle or placebo~     during the first 4 week phase on a 1:1 basis. This blinding will be maintained by the IDS~     pharmacy at the University of Chicago.~   "
55279|NCT02843438|"~     Toxoplasmosis affects one to two newborn each 10000 births. Among them, 1 to 2 % develop~     learning disabilities or die, and 4 to 27 % develop a chorioretinitis sometimes leading to an~     amblyopia responsible for visual impairment. Toxoplasmosis uveitis affects too adults~     immunocompetent and immunodepressed who have had an acquired toxoplasmosis. Clinical~     diagnosis of ocular toxoplasmosis is more complicated in presence of posterior~     neuro-retinitis, inflammation of the papilla, uveitis without chorioretinitis, fuchs~     heterochromic iridocyclitis, scleritis, diffuse necrotizing or multifocal retinitis. In this~     situation biological markers diagnostic and prognostic of toxoplasmosis uveitis are useful.~      Highly kept molecules (during evolution) like stress proteins (Hsp) are are found in the host~     and the pathogen and there can trigger a crossed immune response. Stress proteins haven't~     been explored yet, in the context of toxoplasmosis uveitis on humans.~      The hypothesis is that Hsp70 and antibodies anti-Hsp70 are diagnostic and prognostic markers~     of ocular toxoplasmosis.~      The goal is to evaluate diagnosis value of biological markers (Hsp70 and antibodies IgG~     anti-Hsp70) in toxoplasmosis uveitis.~   "
55280|NCT02843425|"~     You are being asked to take part in this study because either you are an MD Anderson patient~     who had a precancerous colorectal polyp or you have a previous history of colorectal cancer,~     and you have a current adult body mass index (BMI) score of 25 or higher.~      The BMI score is used as an indicator of the level of body fat, based on height and weight.~      The goal of this clinical research study is to learn if eating canned, pre-cooked beans can~     help improve the levels of healthy bacteria in the digestive system and reduce the effects of~     obesity on cancer risk.~      This is an investigational study.~      Up to 80 participants will be enrolled in this study. All will take part at MD Anderson.~   "
55283|NCT02843386|"~     After the local treatment of the primary tumor (protonbeam-therapy, enucleation, external~     radiotherapy) patients with high risk of metastasis are randomized between:~        -  Adjuvant chemotherapy with Fotemustin.~        -  Observation~      Both groups are followed during 3 years for Metastasis- Free Survival, safety and tolerance~     of Fotemustin, quality of life, and Overall Survival.~   "
55284|NCT02843373|"~     The overarching goal of this research program is to elucidate causal and directional neural~     network- level abnormalities in depression, and how they are modulated by an~     individually-tailored, circuit-directed intervention. By using concurrent TMS and EEG, the~     investigators can overcome a major limitation of EEG - the inability to demonstrate~     causality. Here, we plan to recruit patients with medication-resistant depression undergoing~     rTMS treatment. At multiple time points, we will perform TMS-EEG to investigate the~     excitability and connectivity profiles of brain networks and how they are modulated during~     treatment. This study aims to provide objective brain network measures that can predict and~     track clinical response to TMS treatment. Findings from this study will be utilized to~     develop a novel, personalized treatment protocol based on individual brain networks.~   "
55285|NCT02843360|"~     The major elements of the survey were sampling, questionnaire design, field survey and~     database construction. This survey incorporated the multistage stratified sampling scheme.~     Questionnaires include health status, utilization of health care, health behaviors, quality~     of life, and social economic status.~   "
55286|NCT02843347|"~     The STRIDE Biorepository is an optional substudy available to participants in Bone Marrow~     Transplantation vs Standard of Care in Patients with Severe Sickle Cell Disease (BMT CTN~     1503) (STRIDE).~   "
55287|NCT02843334|"~     Fabry Disease (FD) is a rare genetic lysosomal storage disease including an X-linked mutation~     and characterized by an alpha-galactosidase A (GLA) deficiency. It causes~     globotriaosylceramide (GB3) accumulation within blood vessels, tissues and organs. This~     accumulation leads to multisystemic deficiency, such as progressive kidney insufficiency. Due~     to its low prevalence and non-specific symptoms, FD is under-diagnosed. Its estimated~     incidence is ranged from 1/40,000 to 1/120,000 live births. A review of the international~     literature suggests a higher prevalence among dialysis patients. Its diagnosis could lead to~     an enzyme replacement therapy, in order to avoid the occurrence or aggravation of other~     organs irreversible lesions, and to enhance the familial screening.~      We aim to conduct a multicentric cross-sectional prevalence study in 5 areas~     (Rhône-Alpes-Auvergne, Ile de France, Aquitaine, Picardie and department of Gard), involving~     biologic collection and genetic diagnosis test. Our objective is to measure the prevalence of~     FD among dialysis patients. Eligible patients will be included after signing the informed~     consent.~      In the five participating areas, all of the dialysis centers will be asked for involvement.~     Nominative data of the French renal epidemiology and information network (REIN) registry will~     enable first patients screening for eligibility among prevalent dialysis patients. If needed~     (insufficient or absent data in the REIN registry), data will be completed with medical~     files.~      A blood drop will be collected during a hemodialysis session (or the monthly test for~     peritoneal dialysis treated patients) and deposited on an anonymized blotting paper. For the~     diagnosis of FD, men will have a measure of the alpha-galactosidase activity, whereas~     screening in women will be established on the association of alpha-galactosidase activity and~     lyso-GB3 analysis. If results are compatible with FD, genetic mutation will be search in~     order to confirm the diagnosis for women, and, for all, to offer familial testing. Results~     will be transmitted to the nephrologist within the next 2 to 9 weeks. Patients diagnosed with~     FD will be managed in accordance with the guidelines of the French National Authority for~     Health (F.N.A.H.).~   "
55288|NCT02843321|"~     To assess the safety and biological efficacy of prophylactically administered donor-derived~     multi-infection specific cytotoxic T lymphocytes (CTLs) (targeting cytomegalovirus (CMV),~     Adenovirus (Adv), Epstein Barr virus (EBV), Varicella-Zoster virus (VZV), Influenza (Flu), BK~     virus (BKV), and Aspergillus (Asp)) combined with early immunisation with Influenza and VZV~     vaccines for the prevention of viral and fungal infection following allogeneic blood or~     marrow stem cell transplantation.~   "
55289|NCT02843308|"~     The proposed study aims to investigate the efficacy of adding in-home decluttering practice~     to Buried in Treasures Workshop (BIT) facilitated group treatment for hoarding disorder.~   "
55290|NCT02843295|"~     Chronic Allograft Nephropathy (CAN), a major cause of late allograft failure, is~     characterized by a progressive decline in graft function correlating with tissue destruction.~     Recent data suggest that it may be possible to delay graft destruction if adequate management~     is initiated early (ie, at the stage of subclinical CAN). It is therefore essential to design~     new tests allowing physicians to predict transplant recipients prone to develop CAN~   "
55291|NCT02843282|"~     The purpose of this study is to examine cognitive and brain changes in individuals with~     bipolar disorder as a result of a cognitive training intervention.~   "
55292|NCT02843269|"~     Several RCT studies have aimed to reduce either musculoskeletal disorders, sickness~     presenteeism, sickness absenteeism or a combination of these among females with high physical~     work demands. These studies have provided evidence that workplace health promotion (WHP)~     interventions are effective, but long-term effects are still uncertain. These studies either~     lack to succeed in maintaining intervention effects or lack to document if effects are~     maintained past a one-year period. FRIDOM (FRamed Intervention to Decrease Occupational~     Muscle pain) is a WHP program among health care workers. A job group characterized by having~     high physical work demands, musculoskeletal disorders, high sickness presenteeism - and~     absenteeism.~      FRIDOM aimed to reduce neck and shoulder pain and secondary to reduce sickness presenteeism~     and sickness absenteeism. An other secondary aim was to decrease lifestyle-diseases such as~     other musculoskeletal disorders as well as metabolic-, and cardiovascular disorders - and to~     maintain participation to regular physical exercise training, after a one year intervention~     period. The entire concept was tailored to a population of female health care workers. This~     was done through a multi-component intervention including 1) intelligent physical exercise~     training (IPET), dietary advice and weight loss (DAW) and cognitive behavioural training~     (CBT).~   "
55293|NCT02843256|"~     Carbon-12 and carbon-13 are naturally-occurring isotopes that are found in exhaled breath.~     Investigators have proved that the 13CO2/12CO2 breath delta value (BDV) changes in subjects~     who were in negative energy balance then fed a positive energy balance meal. Measuring one~     liter of exhaled breath daily may be a more convenient way to measure negative or positive~     energy balance in patients receiving intravenous nutrition.~   "
55294|NCT02843243|"~     A risk stratification in hemodynamically stable patients with acute pulmonary embolism (PE)~     is deemed necessary to guide patient management. With the aim to improve the positive~     predictive value (PPV) for PE-related adverse events in in normotensive patients, a number of~     scores combining multiple risk-factors have been published. In addition, an algorithm for the~     risk-stratification of patients with PE has been proposed by the European society of~     cardiology. None but one of these scores underwent external and prospective validation. The~     aim of this study is to externally and prospectively validate the PPV for PE-related adverse~     events of the Bova score and modified FAST score in a large multicenter cohort.~   "
55295|NCT02843230|"~     This research study aims to predict treatment response to anti-angiogenic therapy (Avastin)~     using advanced magnetic resonance imaging (MRI) and spectroscopy (MRS) for Glioblastoma~     patients.~   "
55299|NCT02843178|"~     Improving diets through increased food and vegetable (F&V) consumption significantly reduces~     the risk of cardiovascular disease (CVD). Programs increasing the accessibility and~     affordability of F&Vs among low-income Americans have been hindered by the food consumption~     cycle associated with poverty: the tendency to over-consume calories shortly after receiving~     funds at the beginning of each month, draining the budget for F&V purchases, or for all food~     purchases, by month's end. An emerging theory about dietary behavior suggests that providing~     funds for food in smaller installments distributed throughout the month will smooth the~     consumption cycle and improve healthy eating—counteracting the tendency to respond to lump~     sum, once-monthly funding installments by purchasing calorie-dense foods immediately after~     funds are received. The theory also suggests that funds targeted toward specific healthy~     foods (e.g., F&Vs) will improve diets more than untargeted funds, despite the inconvenience~     of utilizing targeted funds. We will rigorously test both hypotheses in a real-world setting~     by comparing alternative approaches for delivering food purchasing vouchers. We have~     established and tested the infrastructure to provide vouchers accepted by numerous food~     sellers (e.g., supermarkets, corner shops) in low-income neighborhoods. Leveraging this~     infrastructure, we will conduct a randomized trial with a two-by-two factorial design,~     comparing $20 of vouchers valid for one month to four $5 vouchers each valid for a sequential~     week of the month (lump sum versus distributed funding), and comparing vouchers restricted to~     F&V purchases to vouchers redeemable for any food (targeted versus untargeted funding).~     Low-income adults (N=288) recruited through our community partners will be randomized to one~     of four 6-month interventions: monthly targeted, monthly untargeted, weekly targeted, or~     weekly untargeted vouchers. Participants will be assessed through efficient verbal 24-hour~     dietary recalls validated among low-literacy populations, to determine daily consumption of~     F&Vs and metrics of overall dietary quality at months 0, 6 and 12 (6 months after vouchers~     end). Additional surveys will identify moderators and mediators of dietary improvement.~   "
55300|NCT02843165|"~     The purpose of this study is to determine whether stereotactic body radiation therapy (SBRT)~     combined with checkpoint blockaded immunotherapy (CBI) will improve the response to the~     anticancer treatment compared to CBI alone in patients with advanced metastatic cancer.~   "
55301|NCT02843152|"~     This study use Loewenstein cognitive function rating scale to meet the standards of the~     elderly cognitive function assessment. POCD diagnostic criteria used is the recommended value~     Z current international law, in order to reduce the effects of exercise, we selected 50 cases~     of patients with age-matched healthy control group as a spouse, the same scale testing. And~     Loewenstein Assessment Scale cognitive function after some domestic research proved to have~     good sensitivity, and easy to test small changes in cognitive ability.~      Before the investigation began strict inclusion and exclusion criteria, the use of simple~     intelligence scale exclude preoperative cognitive decline in the elderly significantly, the~     use of depression rating scale for anxiety rating scale before surgery to exclude severe~     depression and severe anxiety in elderly self self patient. Testing by the same person in the~     same way neurocognitive assessment test twice, 7 days apart.~      Studies in Chinese population, susceptibility SNPs and genetic POCD but there are few reports~     of this project uses 1: 1 matched case-control study, by comparison POCD SNPs and control~     groups of different polymorphisms, polymorphisms Discussion Han population of postoperative~     cognitive dysfunction associated with susceptibility to find Chinese Han population of~     postoperative cognitive disorders genetic susceptibility markers, which provide scientific~     screening and early diagnosis of postoperative cognitive impairment at high risk in~     accordance with~   "
55302|NCT02843139|"~     Childhood obesity certainly increases susceptibility to type 2 diabetes (T2D) in adulthood.~     Recently, microRNAs (miRNAs) are closely related to various diseases and have been suggested~     as valuable biomarkers. Here, we sought to identify potential miRNAs to discriminate obese~     children at risk for diabetes in future.~   "
55303|NCT02843126|"~     The aim of this study is the safety and efficacy of Trastuzumab plus natural killer(NK)~     immunotherapy to recurrent breast cancer.~   "
55304|NCT02843113|"~     Through Stepping Up 4 Your Child, non-custodial fathers will be provided with a~     comprehensive, solution-oriented program featuring group based parent education and~     individualized case management to help them achieve financial independence, increase their~     parenting skills, and develop a co-parenting alliance.~   "
55305|NCT02843100|"~     The modified-Exclusive Enteral Nutrition (mEEN) is an open label randomized controlled pilot~     trial in mild to severe Crohn's Disease patients. The purpose of this study is to determine~     whether induction of remission and maintenance of remission can be achieved with a new~     dietary strategy that involves only 2 weeks of Exclusive Enteral Nutrition (EEN) with Modulen~     and 12 weeks of an exclusion diet involving selected table foods. This novel approach will be~     compared to the gold standard dietary regime involving 8 weeks of EEN.~   "
55306|NCT02843087|"~     The impact of breastfeeding on the infant microbiome in vaginally and Cesarean delivered~     offspring from obese and normal weight mothers.~   "
55307|NCT02843074|"~     This is a phase 2, single arm, open-label, multicenter study to evaluate the feasibility and~     tolerance of the combination of elotuzumab, lenalidomide, and dexamethasone in the induction,~     consolidation, and maintenance treatment of transplant eligible, newly diagnosed multiple~     myeloma patients.~   "
55308|NCT02843061|"~     The aim of this study is the safety and efficacy of Rituximab plus NK immunotherapy to~     recurrent B lymphoma.~   "
55309|NCT02843048|"~     Despite being effective in weight reduction in severely obese patients, bariatric surgery~     (BS) negatively influences bone metabolism and increases the risk of falls thereby~     potentially increasing the risk of fracture. The mechanisms of BS induced bone loss are~     unknown but may be related to calcium and vitamin D malabsorption, changes in the energy~     regulation metabolism and gastrointestinal hormonal physiology. Since the etiology of BS~     induced bone loss is largely unknown, treatment relies mostly on calcium and vitamin D~     supplementation, which provide little benefit.~      Exercise is an effective strategy to prevent bone mass losses in several health conditions.~     However, no study so far has examined the effects of an exercise-training program in the~     prevention of BS induced bone loss. The investigators main goal is to investigate the effects~     on bone metabolism and fracture risk of an exercise-training program specifically tailored to~     improve bone health and balance of patients that underwent BS. The investigators will perform~     a randomized controlled trial on obese patients (n=80; BMI>40 Kg.m-2) elected to BS. Patients~     will be randomly assigned into 2 groups i) a group receiving standard follow-up and medical~     care, or ii) a group that will undergo a 11 months' Exercise Training program designed to~     improve bone health and reduce fall risk plus the standard follow-up and medical care. All~     patients will be assessed i) before the surgery, ii) one month, iii) 6 months, and iv) 12~     months after the surgery. Assessments include: biochemical markers of bone turnover (BTM),~     BMD, bone tissue biomechanical properties, hormones involved in the regulation of energy,~     gastrointestinal and bone metabolism, body composition, BMI, nutritional intake, balance,~     muscle strength, cardiorespiratory fitness and daily physical activity. These evaluations~     will allow the investigators to understand the effects of an exercise-training program on~     bone metabolism of BS patients, contributing also to further elucidate the mechanisms~     underlying BS induced bone loss and fracture risk increase. The investigators will use~     established methods in the literature as well as novel procedures, which will enable them to~     overcome some of the limitations of previous studies. At the end of the study the~     investigators expect to have collected consistent data about whether an exercise-training~     program is or is not able to effectively prevent BS induced bone losses and fracture risk~     increases.~   "
55366|NCT02842294|"~     The primary aim of this french multicenter national study is to assess and compare time to~     quality of life score deterioration (targeted dimensions : global health, fatigue and~     emotional functionning of EORTC QLQC30 according to the first line chemotherapy associated~     with bevacizumab in metastatic colorectal patients.~   "
55310|NCT02843035|"~     Primary Objective:~      Part 1:~        -  Evaluate central nervous system (CNS) biomarkers in adult Gaucher disease (GD) type 3~          (GD3) patients that distinguish GD3 from Gaucher disease type 1 (GD1).~        -  Screen adult GD3 patients who qualify for treatment with GZ/SAR402671 in Part 2.~      Part 2:~        -  Evaluate the safety and tolerability of GZ/SAR402671 in adult GD3 patients.~        -  Evaluate the change in cerebrospinal fluid (CSF) central nervous system (CNS) biomarkers~          from adult GD3 patients receiving GZ/SAR402671.~      Secondary Objectives:~        -  Evaluate the pharmacokinetics of GZ/SAR402671 in adult GD3 patients.~        -  Explore the efficacy of GZ/SAR402671 in infiltrative lung disease (IDL) in adult GD3~          patients.~        -  Explore the efficacy of GZ/SAR402671 in systemic disease in adult GD3 patients.~        -  Explore the efficacy of GZ/SAR402671 in neurological function and on exploratory CSF~          biomarkers in adult GD3 patients.~   "
55311|NCT02843022|"~     The purpose of the study is to determine whether a web-based nursing intervention delivered~     during the postpartum period will decrease symptoms of postpartum depression and parenting~     stress.~   "
55312|NCT02843009|"~     Skeletal muscle is the largest organ in the human body and has many important roles in~     determining our physical abilities and overall wellbeing. One major function of skeletal~     muscle is to carry out many daily tasks, such as rising from a chair or getting on a bus,~     tasks often referred to as functional abilities. During healthy ageing muscle size is reduced~     by approximately 0.5-2% a year (known as sarcopenia), with concurrent reductions in~     functional abilities. This can result in a reduction in quality of life and loss of~     independence, both of which are clearly not desirable. The incidence of sarcopenia is around~     20% between 50-70 years and around 50% in those over 80 years, with the absolute numbers and~     the average age of the population rising. One method through which muscle function can be~     enhanced and retard the progression of sarcopenia, across all age groups, is through~     exercise. The effectiveness of exercise will depend on a number of genetic and environmental~     factors, with nutritional intake being one of the most important and easily altered. Recent~     research has suggested that altering the type of fatty acids consumed may have a positive~     effect on muscle function. Little research is yet to be carried out in elderly humans. This~     is important as that findings from animal models are not definitively transferrable to~     humans. The main aim of the current proposal, therefore, is to investigate the effect the~     consumption of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), long chain~     polyunsaturated fatty acids found in oily fish, on the response to a resistance training~     programme in the elderly. A further aim is to determine the mechanisms which result in these~     adaptive responses. The project will be centred round a large 18 week resistance~     training/nutritional (EPA/DHA) intervention with both males and females over the age of 65~     years. There are three main research questions and experiments stemming from this~     intervention. 1) Does the consumption of EPA and DHA result in a greater increase in~     strength, power and functional abilities in response to resistance training? To answer this~     question a series of measures of muscular performance and functional abilities will be~     assessed. 2) Does the consumption of EPA and DHA increase the size and quality of muscles,~     reduce the amount of fat found within the muscle and decrease inflammation? To address this~     question the participants will have MRI images of their muscles and blood samples taken~     before and after the intervention. This will allow the calculation of muscle mass/fat content~     and circulating levels of inflammatory markers. 3) Does the consumption of EPA and DHA~     enhance the activity of the molecules involved in controlling muscle mass after a single bout~     of resistance exercise? For this question muscle samples will be obtained before and after a~     single training session and measure changes in molecules previously identified as important~     in the changes in muscle mass in response to exercise. A fourth aim running throughout the~     proposal is 4) Do males and females respond differently to the combination of EPA/DHA and~     resistance exercise? Differences in protein metabolism have previously been noted between~     genders and yet the investigation of these differences is often overlooked. The investigators~     will investigate this by studying responses in groups of males and females. In summary, the~     aim of the proposed project is to test the hypothesis that the consumption of fatty acids~     found in oily fish will improve the response of an elderly population to a resistance~     training intervention. The major outcome of the proposal would be in establishing a~     beneficial effect of fish oil on muscular adaptation in the elderly, opening up a widely~     available therapeutic strategy for an improvement in the quality of life in the elderly~     population. Such strategies are of particular importance due to the increasing age of the UK~     population.~   "
55313|NCT02842996|"~     With an ageing population, hip fractures are likely to become a significant public health~     burden. Hip fracture surgery is associated with significant morbidity and mortality. Patient~     outcomes and experience underpin the National Health Service (NHS) Constitution in driving~     quality improvement and performance.~      We aim to conduct a qualitative research study to ascertain the important patient and carer~     reported experience measures following hip fracture surgery in the elderly to improve quality~     of care and service provision.~      To learn about patient and care-giver experience to ascertain which aspects are important to~     patients and what can be improved.~   "
55314|NCT02842983|"~     After initial hemodynamic stabilization, 36 septic shock patients with heart rate > of 90 bpm~     and requiring norepinephrine to maintain mean arterial pressure (MAP) more than 65 mmHg will~     be randomised into two groups, esmolol group and control group. Patients allocated to esmolol~     group will receive a continuous esmolol infusion to maintain a lowering of heart rate of 10%.~     Norepinephrine will be titrated to achieve a MAP more than 65 mmHg. To investigate myocardial~     performance, the investigators will assess Tissue Doppler imaging by echocardiography and~     hemodynamic measures. Data will be obtained at baseline ,after esmolol infusion once achieved~     the predefined heart rate threshold and 72hours after esmolol infusion.~   "
55315|NCT02842957|"~     The primary purpose of the current 6-month study is to determine the effect of an integrated,~     comprehensive, individualized, intervention program including dietary, exercise, pharmacy,~     and behavioral counseling on patient performance of the short physical performance battery~     (SPPB) which gives an indication of an individual's ability to perform activities of daily~     living dependent upon lower extremity function. Additional objectives include the impact of~     the intervention on cardiovascular risk factors, and the impact of the intervention on other~     indices of physical function in stage 3-4 CKD patients. The investigators hypothesize that~     patients who participate in this integrated, intensive, individualized lifestyle intervention~     will have higher SPPB scores compared to individuals in the usual care group. The~     investigators also hypothesize that this approach will lead to higher adherence rates to the~     lifestyle recommendations and that those who adhere will also show better improvements in the~     measured variables over time compared to patients who are randomly assigned to the usual care~     group or who comply poorly with the various study components.~   "
55316|NCT02842944|"~     The purpose of this study is to compare mechanical ventilation following advice from the~     Beacon Caresystem to that of routine care in patients from the state of requiring invasive~     mechanical ventilation until successful extubation. The Beacon Caresystem will be compared to~     routine care to investigate whether use of the system results in similar care and reduced~     time for weaning from mechanical ventilation.~   "
55317|NCT02842931|"~     Purpose: to evaluate an efficacy of chemotherapy regimens R-DA-EPOCH-21 and R-mNHL-BFM-90~     with and without autologous hematopoietic stem cells transplantation (auto-SCT) in newly~     diagnosed patients with DLBCL with intermediate and high risk.~   "
55318|NCT02842918|"~     No studies have investigated the effects of a supine thoracic spine manipulation (TSM) on~     neurodynamic mobility, as compared to a sham intervention. This study aims to determine the~     immediate effects of TSM on the Upper Limb Provocation Test (ULPT) and Seated Slump Test~     (SST) compared to a sham intervention in asymptomatic subjects with neurodynamic limitations.~   "
55319|NCT02842905|"~     Most of us will experience some degree of hearing loss as we get older. It can affect one or~     both ears and without treatment causes difficulty with following conversations in the home or~     workplace. Audiologists are trained to diagnose and treat hearing loss and tinnitus problems.~     They also dispense, and fit hearing aids. Physicians do not provide or fit hearing aids~     directly, however they diagnose hearing loss and can recommend hearing aids amongst other~     treatments for hearing loss. It is undecided whether consulting with a physician in addition~     to an audiologist will improve user's satisfaction with hearing aids, compared to consulting~     with an audiologist alone.~      The purpose of this study is to determine whether physician involvement (in addition to an~     audiologist) in the hearing aid fitting process improves users' satisfaction with hearing~     aids. The study utilizes questionnaires to assess satisfaction with hearing aids.~     Furthermore, participants decision to keep the purchased hearing aids will be recorded.~      The study will take place in the clinics of family doctors, Otolaryngology (Ear) surgeons and~     audiologists. A hearing aid suitable for the needs of the participant will be fitted by an~     audiologist. In the first 21days after the fitting, participants will attend follow-up visits~     with the audiologists for adjustments to the hearing aids to best meet their specific~     listening needs. After 21 days, eligible participants will be allocated to either the Control~     or Test groups. Participants in both groups will be asked to describe the change in their~     hearing performance related to the use of hearing aids to their audiologist(Control) or~     Physician (Test) at a follow-up visit. At the study's final visit, participants will be asked~     to complete a satisfaction-based questionnaire.~      The time taken to fit a hearing aid varies depending on the individual needs of the patient.~     It is estimated that at most 10 visits will be required over 90 days to complete the hearing~     aid fitting and study processes. These visits will be of 30 minutes duration on average,~     except for the initial and final visits which lasts for 45 minutes. A patient will spend a~     maximum of 330 minutes to complete the hearing aid fitting process, but only 25 minutes of~     this time will be specifically related to the study.~      The study is intended to determine the satisfaction with hearing aids and consultations with~     health professionals.~   "
55329|NCT02842775|"~     Cervical myelopathy is common among the aging population.One of the complications of cervical~     myelopathy is balance impairment.In this study, the patients with cervical myelopathy undergo~     biomechanical, imaging, neurophysiological and functional assessment. Besides, the dynamic~     balance training is introduced to the patients with cervical decompression surgery.This study~     is expected to provide important empirical evidence to evaluate the prognosis of the surgery,~     to further guide the postoperative rehabilitation of myelopathy patients and to improve~     patients' long-term quality of life.~   "
55330|NCT02842762|"~     This study evaluates the usefulness of 3D echocardiography to guide pacemaker therapy in the~     operating room in cardiac surgical patients. Each patient will serve as his own control,~     following a paired design.~   "
55320|NCT02842892|"~     For optimal jumping performance an adequate interaction of muscles and tendons is required. A~     parameter in the functional evaluation of both structures is their stiffness (resistance of~     the tissue against deformation by external forces). It is unclear so far if higher stiffness~     values of tendon or muscle or a specific stiffness relation of both tissues is the cause of~     better jumping performance. The present study examines this based on the Achilles tendon and~     the calf muscles or the patellar tendon and the hamstrings by three different forms of jumps~     (squat jump, counter-Movement Jump, Drop-Jump).~      The plan is to include young healthy volunteers aged 18 to 40 years. In a cross-sectional~     study, the jump height of the participants will be measured for each jump form: squat jump~     (jump from a squatting position), Counter-Movement Jump (jump with backswing by going into~     the knees) or drop jump (jump from small box with direct re-jump). The order of the jump form~     is determined randomly. The measurements are carried out within one day. Furthermore the~     international physical activity questionnaire will be used in order to assess the level of~     physical activity.~      As primary outcome the stiffness of the calf muscles, achilles tendon, hamstring and patellar~     tendon will be detected. The measurement is carried out before the jumps (there are three~     jumps after one sample jump performed). The measurement is executed non-invasively and~     completely painless using Indentometers and MyotonPro. With both devices, minimal pressure on~     the examined tissue will be exerted and measured how much of this can be compressed.~   "
55321|NCT02842879|"~     The aim was to conduct a non-blinded prospective randomized study at a tertiary hospital.~     Inclusion criteria: term pregnancy with a single fetus in cephalic presentation, Bishop score~     < 6, gestational age > 41 weeks or medical indication for induction of labor.~      Patients will be randomized to outpatient or inpatient cervix priming with Foley catheter.~      The primary outcome will be to compare the variation of Bishop score (difference between~     Bishop score before and after application of Foley catheter) between outpatient and inpatient~     groups. Secondary comparisons include: mode of delivery, Foley catheter~     application-to-delivery time, inpatient time, sequential use of prostaglandins, infection and~     maternal pain.~   "
55322|NCT02842866|"~     The aim of the study is to demonstrate non-inferiority of immunogenicity and evaluate the~     safety of a single dose of MenACYW conjugate vaccine compared to a single dose of Menomune® -~     A/C/Y/W-135 in adults 56 years of age and older in the US.~      Primary objective:~        -  To demonstrate the non-inferiority of the vaccine seroresponse to meningococcal~          serogroups A, C, Y, and W following the administration of a single dose of MenACYW~          conjugate vaccine compared to those observed following the administration of a single~          dose of Menomune® - A/C/Y/W-135.~      Secondary objective:~        -  To compare the hSBA antibody geometric mean titers (GMTs) of meningococcal serogroups A,~          C, Y, and W following the administration of MenACYW conjugate vaccine to those observed~          following the administration of Menomune® - A/C/Y/W-135~      Observational objectives:~        -  To describe antibody titers against meningococcal serogroups A, C, Y, and W measured by~          hSBA at baseline (before vaccination) and 30 days after vaccination with MenACYW~          conjugate vaccine or Menomune® - A/C/Y/W-135.~        -  To describe the safety profile of MenACYW conjugated vaccine compared to that of the~          licensed Menomune® - A/C/Y/W-135 after a single administration.~   "
55323|NCT02842853|"~     The purpose of the study is to demonstrate the immune lot consistency of the antibody~     responses to meningococcal serogroups A, C, Y, and W following the administration of a single~     dose of MenACYW conjugate vaccine and to demonstrate the immune non-inferiority of the~     antibody responses to meningococcal serogroups A, C, Y, and W following the administration of~     a single dose of MenACYW conjugate vaccine vs licensed MCV4 vaccine.~      Primary Objectives:~        -  To demonstrate the immune lot consistency of the antibody responses to meningococcal~          serogroups A, C, Y, and W following the administration of a single dose of MenACYW~          conjugate vaccine with respect to serum bactericidal assay using human complement (hSBA)~          geometric mean titers.~        -  To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups~          A, C, Y, and W following the administration of a single dose of MenACYW conjugate~          vaccine (pooled Lots 1 to 3) compared to those observed following the administration of~          a single dose of licensed MCV4 vaccine.~      Secondary Objective:~        -  To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups~          A, C, Y, and W following the administration of a single dose of MenACYW conjugate~          vaccine (pooled Lots 1 to 3) compared to those observed following the administration of~          a single dose of licensed MCV4 vaccine in the adult population (18 to 55 years old)~        -  To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups~          A, C, Y, and W following the administration of a single dose of MenACYW conjugate~          vaccine (pooled Lots 1 to 3) compared to those observed following the administration of~          a single dose of licensed MCV4 vaccine in the adolescent population (10 to 17 years old)~      Observational Objectives:~        -  To describe the safety profile of MenACYW conjugate vaccine and that of the licensed~          MCV4 vaccine.~   "
55324|NCT02842840|"~     Stroke is a major cause of morbidity and mortality, especially in low and middle income~     countries including Iran. Patients with recent stroke or TIA are at high risk for new~     vascular events. Several evidence based strategies in secondary prevention of stroke are~     available but frequently underused. The study is aimed to evaluate an intervention to improve~     patients with Stroke.~   "
55325|NCT02842827|"~     This is a Phase 1 open label study of the dose and duration of an orally administered LSD1~     inhibitor, IMG-7289, in patients with acute myeloid leukemia (AML) and myelodysplastic~     syndrome (MDS). Some participants may also receive all-trans retinoic acid (ATRA; also known~     as tretinoin and Vesanoid®) in combination with IMG-7289. This study investigates the~     following:~        -  The safety and tolerability of IMG-7289, with and without ATRA~        -  The pharmacodynamic effect of different IMG-7289 doses and treatment durations, as well~          as IMG-7289 administered in combination with ATRA~        -  The pharmacokinetics of IMG-2789, with and without ATRA~   "
55326|NCT02842814|"~     Whether and when systemic lupus erythematosus (SLE) patients with stable disease should~     withdraw glucocorticoid (GC)? How about the relapse risk? What are the risk factors for~     disease flare? All the above are unclear. Long-course GC treatment has a lot of side-effects~     even in a sustaining low dose. The aim of this study is to explore the relapse risk after GC~     withdrawal in SLE patients with stable disease more than one year and to establish a~     predictive model for flare risk stratification.~   "
55327|NCT02842801|"~     The purpose of the study is to identify the characteristics of young adults with pain in the~     groin, lateral hip or buttock who will benefit from manipulation of the hip.~   "
55328|NCT02842788|"~     Prone positioning has been shown to improve survival in patients with acute respiratory~     distress syndrome (ARDS). However, a recent large observational study found that prone~     positioning was used in only 7% of all ARDS patients, and 16% in the severe category.~     However, this study did not focus on the prone position per se. In present study, the~     investigators would like to explore the rate of use of prone positioning in ARDS patients and~     the reasons why this treatment was not applied. The present study is one-day prevalence study~     repeated four times over one year.~      The hypothesis is that the rate of use of prone position is greater than 50% in the severe~     ARDS category.~   "
55331|NCT02842749|"~     To evaluate safety and efficacy of everolimus (Afinitor®) in Chinese adult patients with~     local advanced or metastatic, well differentiated progressive pancreatic neuroendocrine~     tumors.~   "
55332|NCT02842736|"~     The purpose of the study is to evaluate the safety and effectiveness of the Cerene~     Cryotherapy Device in reducing menstrual bleeding in women with heavy menstrual bleeding~     (menorrhagia) due to benign causes for whom child bearing is complete.~   "
55335|NCT02842697|"~     This is a prospective, multi-center trial conducted at 1 Guangzhou and 2 Beijing centers~     designed to determine the diagnostic performance of virtual hepatic venous pressure gradient~     (vHVPG) (investigational technology) by anatomic computed tomographic angiography (CTA) for~     non-invasive assessment of the clinically significant portal hypertension (CSPH) in patients~     with compensated cirrhosis. Direct hepatic venous pressure gradient (HVPG) measurement by~     means of catheterization of a hepatic vein with a balloon catheter is the gold-standard~     method to assess the presence of CSPH, which is defined as HVPG≥10 mmHg.~   "
55336|NCT02842684|"~     Preoperative planning has been carried out to allow for response preparedness . A layer~     technique is usually used with standard radiography .The investigators have a record of~     routine preoperative radiographs by standard recognized as having an advantage over the~     reproducibility of measurements compared with plain radiography . The Toulouse Hospitals have~     developed this technology and is part of the routine assessment of hip prothesis pre and~     postoperatively.~      The TraumaCad software can superimpose implants on Picture Archiving and Communication System~     and evaluate digital and reproducible size of the implants and their correct position .~      This is to demonstrate the superiority of modern digital tools in the preoperative~     preparation in Orthopaedics set.~   "
55337|NCT02842671|"~     The investigators are evaluating the implementation and the effectiveness of a medical~     student staffed support program (ASAP) for children diagnosed with Autism Spectrum Disorder~     coming into Penn State Hershey Children's Hospital for a medical procedure. The ASAP program~     involves training and assigning a medical student as an Ambassador to help advocate for the~     special needs of a child with ASD. This study is designed to compare patient satisfaction of~     children and families who are assigned an Ambassador to those who are not assigned an~     Ambassador during the procedure. The secondary objectives are to measure overall medical~     student satisfaction with the program, medical student career interests before and after~     participation, and medical student comfort level interacting with children with ASD before~     and after participation.~   "
55338|NCT02842658|"~     The purpose of this study is to determine whether a supervised exercise-training program,~     initiated prior to chemotherapy induction (pre-conditioning) and continued throughout~     chemotherapy treatment, can preserve short- and long-term cardiovascular performance,~     skeletal muscle function, cognitive ability and quality of life better than current standard~     or care recommendations for exercise during chemotherapy.~   "
55339|NCT02842645|"~     Children exposed to alcohol or drugs during pregnancy: Growth, health and development~     Background Children exposed to drugs during pregnancy are at risk of developmental disorders.~     The scope and size of this problem is poorly known in Norway.~      Alcohol has a known teratogenic effect on the fetus. How other drugs affect the fetus, is~     associated with more uncertainty. Withdrawal in the neonatal period has been perceived as the~     main problem. There is less knowledge about long-term outcome of exposure to drugs during~     pregnancy.~      Aim The aim of the study is to investigate the physical and mental health of children exposed~     to drugs during pregnancy. Identify the children's need for measures in the home and school,~     and how many of the children who are taken care of in fostercare.~      A sample of the children will be offered radiological examination of the brain (f-MRI). The~     purpose is to study the relationship between exposure to drugs, child development,~     environment and organic brain dysfunction.~      Design The project is a quantitative study. The relationship between exposure to drugs and~     development will be measured by questionnaires, clinical examination, neuropsychological~     tests and radiological examination (f-MRI).~      Children aged 2-15years who were referred, examined or treated for drug related problems at~     the Department of Pediatrics, Haukeland University Hospital will be invited to participate in~     the study.~      Information retrieval and examination of the children are expected to be completed during~     2011. Data analysis and further processing of data are expected to be completed during 2013.~   "
55340|NCT02842632|"~     Training in TEE is based on hands-on training in the operation room which is time consuming~     and therefore its use and experience is limited among anesthesiologists.~      Recent studies demonstrate that simulation-based education is also superior to a conventional~     didactic system and superior to hands-on teaching in the OR in terms of theoretical knowledge~     in echocardiography. So far there is no study evaluating the study effect in obtaining the 11~     basic TEE views as recommended by the American Society of Echocardiography (ASE) and the~     Society of Cardiovascular Anesthesiologists (SCA) between simulator training and training in~     the operation room in residents with no prior knowledge of echocardiography. The basic TEE~     examination focus on the 11 most relevant views.~      Therefore the investigators want to assess if there is a difference in the study effect in~     obtaining the 11 basic TEE views and also in theoretical knowledge in 3 groups of residents~     with no prior knowledge of echocardiography:~      the simulation group (CAE Vimedix Simulator), the hands-on OR group and the online group~     (http://pie.med.utoronto.ca/TEE/).~      prospective randomized single-center study. The investigators want to include 51 anaesthesia~     residents (17 per group) in their first or second year of training with no prior knowledge of~     echocardiography in this randomized, Controlled single-centre study.~      The investigators want to assess the pre- and post training scores of the theoretical~     multiple choice test and the practical test in all 3 groups. The multiple choice test~     consists of 50 questions with 1 point per question (max. 50 points) and the practical test is~     an evaluation of 11 basic perioperative TEE examination on the simulator (CAE Vimedix~     Simulator). Each view is evaluated on a scale of 0 to 10 according to predetermined criteria~     including image angle, overall clarity and visualization of 3 major anatomic structures~     pertinent to each view. Each view can receive a maximum score of 10 and each study a maximum~     of 109 (ME asc. aortic LAX has only 2 main structures). Further the time to adjust each view~     and the time to complete the basic TEE Examination will be assessed.~   "
55341|NCT02842619|"~     The purpose of this clinical study is to evaluate the safety and the efficacy of BonoFill-II~     as a bone filler containing the patient's own (autologous) adipose (fat) tissue-derived cells~     in reconstructing bone in two clinical indications:~        1. Bone augmentation (e.g. sinus augmentation)~        2. Bone grafting after removal of cysts from jaws~   "
55342|NCT02842606|"~     Cardio-metabolic diseases are a leading cause of mortality worldwide. Over the years,~     therefore, there have been considerable efforts to identify strategies for prevention and~     management of risk factors. The diet, with its pleiotropic effects, is one of the most~     effective approaches to reduce the cardio-metabolic risk. In this context, the dietary fibers~     have been extensively studied and the available evidence supports the beneficial effects of~     its consumption. However, worldwide the average fiber consumption is still less than the~     recommended daily dose. For this reason, the availability of functional foods, such as~     additional sources of fiber in the diet, may facilitate the attainment of fiber recommended.~   "
55343|NCT02842593|"~     This study evaluates the effects of two types of resistance exercise training~     (higher-repetition, lower load vs lower-repetition, higher load vs control) on regional and~     local measures of arterial stiffness in trained young men.~   "
57255|NCT02817568|"~     The aim of this study is to estimate genetic impact of MCP-1 -2518 and its receptor CCR2 -190~     polymorphisms on AgP patients among Turkish individuals and whether MCP-1 genotype effects~     mRNA levels of Peripheral Blood Mononuclear Cell Leukocyte (PBML)~   "
55344|NCT02842580|"~     The intensity of tumour response appears to be correlated with the feasibility and the~     duration of a therapeutic pause or of a reduced maintenance therapy maintained until~     progression in patients initially controlled by so-called induction chemotherapy.~     Bevacizumab combined with cytotoxic chemotherapy (5-FU, irinotecan and/or oxaliplatin) has~     shown that it is possible to improve the tumour response rate and patient prognosis in 1st~     and 2nd lines. With a very favourable safety profile , it is an excellent candidate as~     induction treatment and also as maintenance treatment. Prospective data from recent trials~     have actually demonstrated improvement in PFS and/or overall survival with bevacizumab~     maintenance alone or in combination with 5FU (or capecitabine) after induction chemotherapy~     (FOLFIRI or FOLFOX + bevacizumab).~      At the same time, the maintenance of anti-angiogenic pressure after progression in 1st line~     metastatic has demonstrated its benefit in terms of PFS and overall survival. Bevacizumab~     maintenance in 2nd line metastatic, despite progression, thus appears to be a valid strategy.~   "
55345|NCT02842567|"~     Non-alcoholic fatty liver disease (NAFLD) has reached epidemic proportions and is rapidly~     becoming the one of most common causes of chronic liver disease in children. The pathogenesis~     of NAFLD is generally considered the result of a series of liver injuries, commonly referred~     as multi-hit hypothesis. Several studies suggest that inflammatory pathways and oxidative~     stress could be responsible of disease progression to non-alcoholic steatohepatitis (NASH).~      Hydroxytyrosol is a simple phenolic compound naturally occurring in olive and olive oil with~     antioxidant properties. Some studies have demonstrated that hydroxytyrosol show several~     anti-inflammatory and anti-atherogenic activities, such as the inhibition of LDL oxidation~     and platelet aggregation.~      Alpha tocopherol (Vitamin E) is the most studied anti-oxydant in pediatric NAFLD with~     conflicting results. It inhibits proinflammatory cytokine production and attenuates the~     release of profibrogenic agents and liver collagen.~      The purpose of this interventional study is to evaluate the efficacy and tolerability of~     Hydroxytyrosol and Vitamin E in the treatment of children with biopsy-proven NASH.~   "
55346|NCT02842554|"~     The purpose of this study is to assess the ability of Evoked Pain Training (EPT) and Drug/~     Placebo Administration (DPA) training to increase subjects' ability to discriminate between~     active and placebo treatments in a double-blind crossover trial of a known analgesic,~     measured by standardized effect size, relative to untrained control subjects.~   "
55347|NCT02842541|"~     The purpose of the study is to evaluate the safety, tolerability, immunogenicity, and~     pharmacokinetics of up to 3 dose levels of EBI-031 given as an intravitreal injection in~     subjects with diabetic macular edema. There are two arms to the study, a single dose arm (1~     dose) and a repeat dose arm (1 dose each month for 3 months). Eligible subjects will~     initially enroll in the single dose arm and 3 to 6 subjects will be dosed at each of the 3~     dose levels. Safety will be assessed over the 28 days after the single dose prior to moving~     to the next higher dose level. Once all subjects in the single dose arm have been dosed with~     EBI-031 and the safety has been assessed eligible subjects will begin enrolling in the repeat~     dose arm. Subjects in the repeat dose arm will receive one dose each month for 3 months and~     will be assessed for safety. Escalation to the next higher dose will occur once it is~     determined safe to proceed to the next dose level. Six subjects will be dosed at each of the~     3 dose levels.~   "
55348|NCT02842528|"~     The purpose of this study is to specify the cognitive and genetic pattern associated with~     alcohol dependence. Results will help identifying more precisely vulnerability factors~     associated with this disorder.~   "
55349|NCT02842515|"~     Current endodontic treatment are based essentially on the ouster of parenchyma in case of~     trauma or irreversible pulp inflammation. These situations typically affect immature teeth in~     subjects aged from 8 to 15 years. Consequently, loss of a functional pulp is leads to~     discontinuation of root development and apical closure. The challenge for the clinician in~     the management of such situations is then preserving a pulp vitality. But current practices~     consist in a filling of the endo-canal system with an inert or semi-inert material. In this~     case, no pulp vitality is present. New treatment methods are needed. The objective Pulp'R is~     the study the feasibility of preparing an autologous combined advanced therapy medicinal~     product (ATMP) for dental pulp regeneration in the patient with irreversible pulp~     inflammation or dental trauma.~   "
55350|NCT02842502|"~     This study deals with the feasibility of an ATMP (Advanced Therapy Medicinal Product)~     production for the treatment of chronic wounds ulcer. Recruitment concerns patients (n=7)~     with leg ulcers and receiving a skin pellet graft. During surgical procedure, supernumerary~     biopsies are planned to be done in order to be transferred to laboratory. Then, the~     possibility of cell extraction (keratinocytes and fibroblasts), expansion, banking and use~     for skin substitute production in clinical condition is evaluated (primary outcome).~   "
55351|NCT02842489|"~     The purpose of this study is to determine whether the left lateral tilt-down position, which~     includes procedures that involve placing patients on their left lateral side at an angle to~     make their heads lower than their feet, is more beneficial than the left lateral horizontal~     body position (patient horizontally laying on their left side, traditionally used for~     colonoscopies) to decrease descending colon insertion time, the difficulty of colonoscopy~     procedure and patients' pain.~   "
55352|NCT02842476|"~     The purpose of this study is to evaluate the SpO2 accuracy and performance of the Cadwell~     Pulse Oximetry system during non-motion conditions over the range of 70-100% SaO2 as compared~     to arterial blood samples assessed by CO-Oximetry for SpO2 validation. The end goal is to~     show the SpO2 accuracy performance of the Cadwell Pulse Oximetry System. It is expected that~     the Accuracy Root Mean Square (Arms) performance of the Cadwell Pulse Oximetry System will~     meet a specification of 3 or better in non-motion conditions for the range of 70-100% SaO2~     thereby demonstrating an acceptable SpO2 accuracy performance specification.~   "
55353|NCT02842463|"~     The purpose of this study is to determine, if it exists, a relation between plateau heart~     rate from the last 3 minutes of the 6-minute stepper test and heart rate from first~     ventilatory threshold from cardiopulmonary exercise testing in order to individualise~     pulmonary rehabilitation in patients with mild to moderate chronicle obstructive pulmonary~     disease.~   "
55367|NCT02842281|"~     This study evaluates whether the gut microbiome is involved in determining whether children~     with irritable bowel syndrome (IBS) develop worsening GI symptoms (e.g. pain) when given~     fructans (a sugar often found in wheat). Participants will both receive a diet with fructans~     and a diet without fructans.~   "
55354|NCT02842450|"~     The diagnosis of LAP (lesions Ano-perineal) requires the inspection, palpation, anoscopy and~     possibly additional examinations including endoscopy and imaging; any of these steps of the~     diagnosis can only be replaced by another.~      In the absence of data in the literature on the evaluation of specific LAP Crohn inspection,~     Clemence Horaist et al established definitions of these lesions inspection with the help of~     an expert group, then evaluated the diagnostic agreement LAP these definitions in the same~     group from a selection of photographs. Definitions ulceration, fistula, inflammatory external~     os, erythema and abscess had an acceptable agreement diagnosis (kappa> 0.70)~      The LAP is a predictor of severe Crohn's disease, hepato any gastroenterologist it is~     appropriate that recognizes and adopts adequate care, this care has been a consensus in 2014.~     The interns Hepato gastroenterology must learn during their training to know the terminology~     of LAP Crohn inspection and to recognize so considered acceptable by experts.~   "
55355|NCT02842437|"~     The purpose of this study is to assess the efficacy of dexmedetomidine on lung protection in~     patient with sepsis undergoing cleaning focus of infection.~   "
55356|NCT02842424|"~     Peripheral artery disease (PAD) is a manifestation of atherosclerosis that produces~     progressive narrowing and occlusion of the arteries supplying the lower extremities. The most~     common clinical manifestation of PAD is claudication, i.e., a severe functional limitation~     identified as gait dysfunction and walking-induced leg muscle pain relieved by rest. The~     standard therapies for claudication include the medications cilostazol and pentoxifylline,~     supervised exercise therapy and operative revascularization. Recent data demonstrated that 24~     weeks of treatment with the angiotensin-converting enzyme (ACE) inhibitor Ramipril produces~     improvements in the walking performance of patients with claudication that are higher than~     those of cilostazol and pentoxifylline and similar to those produced by supervised exercise~     therapy and operative revascularization. The mechanisms by which Ramipril therapy produces~     this impressive improvement in the functional capacity of claudicating patients remain~     unknown. The Investigators hypothesize that treatment of claudicating PAD patients with~     Ramipril will improve walking performance and quality of life by improving the myopathy of~     the gastrocnemius. Improved myopathy is a consequence of reduced oxidative damage, reduced~     TGF-β1 production by vascular smooth muscle cells and reduced collagen deposition in the~     affected gastrocnemius.~   "
55357|NCT02842411|"~     Chronic constipation is one of the risk factors of inadequate bowel preparation, which could~     influence the effect of colonoscopy. The risk factors associated with inadequate bowel~     preparation in constipated patients remains unclear. Here the investigators investigated the~     high risk factors which might have influence on bowel preparation quality in a prospective~     cohort of patients with functional constipation.~   "
55358|NCT02842398|"~     The purpose of this study is to determine if selected sequence training using the Balance~     Master, added to established physical therapy treatment programs, will increase gait velocity~     of ambulatory children receiving inpatient or outpatient rehabilitation in relation to their~     ability to cross an intersection within the confines of community traffic signal (>120~     cm/sec).~   "
55359|NCT02842385|"~     Changes in the marginal bone level surrounding the implant are the frequently used parameters~     in assessing the short- and long-term success. Multiple biological and biomechanical factors~     have been reported to adversely affect marginal bone level. Recently, initial vertical~     mucosal tissue thickness has also been reported to have an impact on bone stability.The~     hypothesis of present study is that soft tissue thickness on implant placement has no~     positive impact of crestal bone remodeling.~   "
55360|NCT02842372|"~     This is a non-interventional prospective study to investigate the treatment response to~     topical application with Ectoin Dermatitis Cream 7% as first-line therapy of grade I acute~     skin graft-versus-host disease.~   "
55361|NCT02842359|"~     Primary Objective:~      To evaluate the effect of irbesartan/atorvastatin fixed-dose combination comparing to each~     irbesartan and atorvastatin on flow mediated dilation change in type 2 diabetic patients~     diagnosed with hyperlipidemia, hypertension.~      Secondary Objective:~      To evaluate efficacy of blood pressure and hyperlipidemic factors of irbesartan/atorvastatin~     fixed-dose combination in type 2 diabetic patients diagnosed with hyperlipidemia and~     hypertension, with adequately controlled blood glucose levels in groups.~   "
55362|NCT02842346|"~     The aim of our study was to investigate the correlation between the umbilical resistance~     index and weight gain during the third trimester of low-risk pregnancies.~   "
55363|NCT02842333|"~     The investigators recently identified promiscuous HLA-DR-derived epitopes from the human~     telomerase reverse transcriptase (TERT) called universal cancer peptides (UCP), to study~     tumor-specific CD4+ T cell responses.~      The aim of this prospective preliminary study is to evaluate the presence of UCP-specific Th1~     responses in patients in complete remission of CML two years after end of Tyrosine Kinase~     Inhibitor (TKi) treatments.~   "
55364|NCT02842320|"~     The tyrosine kinase inhibitor therapy (iTKs) is the first-line treatment of chronic~     myelogenous leukemia (CML).~      Its effectiveness in controlling the progression of the disease is such that it is possible~     today to consider stopping treatment in patients with deep molecular response (> RM4.0).~      Only in about 50% of cases, patients relapse. It has been shown in these patients that~     hematopoietic stem cells (HSCs) are persistant, quiescent and insensitive to iTKs. These~     cells are probably at the origin of relapse. It is therefore necessary to develop~     complementary therapies to cure the disease and consider discontinuation iTKs The development~     of anti-tumor immunotherapy approach using genetically modified T cells to express a chimeric~     antigen receptor (CAR) and specifically targeting CML CSH + could address this issue. The~     membrane expression of the IL-1-RAP protein could be an interesting target.~   "
55365|NCT02842307|"~     This is an expertise-based randomized controlled trial. The hypothesis of this study is that~     the differences in expertise of acupuncturist may impact clinical effect. In this study,~     patients will be randomized to 4 group, receiving the treatment from senior acupuncturist,~     junior acupuncturist, junior acupuncturist by only acupuncture Neiguan(P6), or not receive~     the acupuncture. All patients receive the basic cisplatin chemotherapy. The duration of~     treatment is from the first day receiving cisplatin until two days after cisplatin on each~     group. NCI and Rhode scale will be used to measure the control of nausea and vomiting.~   "
55368|NCT02842268|"~     To visually evaluate the retention of coverage of the Test Product(s) (TP) on the face after~     exercise compared to the full coverage observed prior to exercise.~   "
55369|NCT02842255|"~     This study is about the development of a new medical device for the monitoring of of sleep~     disordered breathing. This device is developed by the CEA-LETI-LE2S and will be composed of~     an oximeter, an actimeter in order to measure the activity level of the subject, his state of~     sleeplessness/sleep, and a CO2 partial pressure transcutaneous sensor (PtcCO2).~      Developing this device is realized in several steps : a study (ALMOST) is already in progress~     and its goal is to acquire a database of polysomnography to create automatic algorithms in~     order to detect respiratory disorders with this device under development.~      The main goal of the study is to calibrate the oxymeter under development.~   "
55370|NCT02842242|"~     The purpose of this phase 2 open-label pilot study is to evaluate the efficacy,~     pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of MYK-461 in subjects~     with symptomatic HCM and LVOT obstruction aged 18-70 years.~   "
55371|NCT02842229|"~     This is a post-authorization, retrospective multicentre observational nationwide study~     (PAS-OD). It will be conducted by reviewing medical records and database of patients who~     participated in the validation of the psychometric properties of the GAH study~     (CEL-GAH-2011-01). In all cases, only data prior to the start date of the study will be~     collected to ensure its retrospective nature, thereby reflecting routine clinical practice~     and non-interference in the physician's clinical practice~   "
55372|NCT02842216|"~     Monocentric study in University Hospitals Leuven (campus Gasthuisberg).~      Hospital medical records from all pregnant women who delivered between 01/07/2015 and~     31/12/2015 in University Hospitals will be analyzed for the presence of medication and~     supplements.~      Some demographic and obstetric parameters will be collected as well.~      The anonymized dataset will be analyzed using descriptive statistics (Excel). There will be~     no intervention among the selected sample.~   "
55373|NCT02842203|"~     This observational study will evaluate circulating tumor DNA (ctDNA) as a prognostic marker~     and as a monitor of disease recurrence in stage III colorectal cancer (CRC).~   "
55374|NCT02842190|"~     Mechanical ventilation is important in the care of preterm infants with respiratory failure,~     but may be associated with lung injury. Efforts are needed to avoid or minimize the use of~     mechanical ventilation. However, there is no consensus on the best non-invasive ventilation~     mode after extubation in preterm infants.~      Objective: To compare the effectiveness of nasal intermittent positive pressure ventilation~     (NIPPV) versus bi-level nasal continuous positive airway pressure (BIPAP) following~     extubation in preterm infants ≤ 1250 g birthweight.~   "
55375|NCT02842177|"~     The intrauterine devices are a safe, reliable, long-acting and reversible contraceptive~     method. It is also sound safe and cheap contraceptive methods available and is nearly~     maintenance free for up to 10 years.~      The fear and the pain associated with intrauterine devices insertion consider barriers to~     using this contraception method, this is because that the mucosal lining of female genital~     tract is highly sensitive to touch and pain. However; most of small procedures done in this~     sensitive area are performed without analgesia.~      The pain during intrauterine devices insertion is due to application of the tenaculum ,~     traction of the cervical canal, passing the uterine sound, insertion of the intrauterine~     devices through the cervix, and irritation of the endometrial lining by the intrauterine~     devices .~      Previous studies have reported different lines to decrease pain during intrauterine device~     insertion starting by simple methods such as pre-insertion ibuprofen use, intracervical or~     intrauterine lidocaine and misoprostol up to paracervical blocks.~      Previous studies, in literature, have found that the most painful steps during intrauterine~     devices insertion were uterine sounding then intrauterine device insertion itself, followed~     by tenaculum placement. One recent study addressed pain effect using an atraumatic vulsellum~     and a single-tooth tenaculum on pain perception during intrauterine devices and found no~     difference in reported pain.~   "
55376|NCT02842164|"~     Induction of abortion is a hot subject that has complex and emotional controversy. The most~     common time of abortion is the second trimester which represent about 10-15% of all induced~     abortions over the world. As well as, two-thirds of all serious abortion-related~     complications are related to induced second trimester abortion.~      There are many causes for induction of abortion in the second trimester such as missed~     abortion, serious fetal abnormalities such as central nervous system or skeletal malformation~     and lastly some women do not wish to continue a pregnancy and will often seek out termination~     of pregnancy.~      Termination of second trimester is more risky than the first trimester. So many lines have~     been emerged to achieve safe and effective method of termination of second trimester.~      Pharmacologic management seems to be an appealing method for induction of abortion. The~     combing between mifepristone and misoprostol is the effective regimen for termination of~     second trimester abortion with success rate reaching about 97-99% within 24 hours.~      However, mifepristone is not available or affordable in many countries worldwide so~     misoprostol have been used alone but it needs higher total dose with lower effectiveness and~     higher percentage of side effects rate than the combined regimens.~      The optimal method for inducing second trimester nulliparous women with an unfavorable cervix~     is not known. Several studies in literature have described the effectiveness of Foley's~     catheter in cervical ripening and improvement of Bishop's score in women with unripe cervices~     . It may act in addition to its mechanical effect by increasing the release of prostaglandin~     and/or oxytocin release secondary to localized inflammation.~      In practice, the insertion of intra-cervical Foley's catheter balloon is followed by applying~     tension in trial to shorten the time between the insertion and expulsion of the fetus,~     however; this tension adds more pain for the pregnant women with higher rate of vaginal~     bleeding and dissatisfaction.~      Gary et al in 2016 concluded that the application of tension did not result in faster~     delivery times, but did result in faster times to catheter expulsion.~   "
55377|NCT02842151|"~     The purpose of this study is to evaluate current available assessments (automated vs. manual)~     with which manifest refraction data and biometric variables are obtained to understand if~     data from an automated refractor can be utilized to optimize the A-constant as well as manual~     subjective refraction (ie, to a clinically insignificant difference). The A-constant is the~     calculated number that helps the surgeon determine which IOL should be implanted in the eye~     during cataract surgery.~   "
55378|NCT02842138|"~     This is a single arm, open-label, one center, dose escalation clinical study to determine the~     safety and efficacy of infusion of autologous T cells expressing CD19-redirected Chimeric~     Antigen Receptor (CD19 CAR T) in adult patients with relapsed or refractory CD19 positive~     B-cell lymphoma.~   "
55379|NCT02842125|"~     This is a Phase 1 study of the combination of Ad-p53 administered intra-arterially in~     combination with oral metronomic capecitabine in patients with unresectable, refractory liver~     metastases of colorectal carcinoma (CRC) and other solid tumors, including primary~     hepatocellular carcinoma (HCC). This safety study has a standard 3+3 design. The Maximum~     Tolerated Dose (MTD) will be determined as well as the general safety and preliminary~     efficacy using RECIST 1.1 and Immune-Related Response Criteria. CEA levels will also be~     followed.~   "
57256|NCT02817555|"~     The purpose of this study is to determine if there is a cost difference between darbepoetin~     alfa and epoetin alfa when used intravenously to treat anemia in hemodialysis patients.~   "
55380|NCT02842112|"~     Over recent decades, improvements have been made in the treatment of adult acute myeloid~     leukemia (AML). This has been mainly attributed to improvements in supportive therapy and to~     intensification of treatment strategies. The introduction of a post-induction myeloablative~     regimen followed by allogeneic stem cell transplant (SCT) has reduced the relapse rate in~     younger adults. However, this procedure is limited by the availability of human leukocyte~     antigen (HLA)-identical donors and conventional SCT preparative regimens according to patient~     age. In the absence of a compatible donor, myeloablative chemotherapy followed by autologous~     peripheral blood (PB) SCT remains one treatment strategy in adult patients with AML, allowing~     35 - 50% long-term survivors. Despite several advantages of the CD34+ cell mobilization~     procedure, recent data have shown that relapse was higher and leukemia-free survival (LFS)~     shorter compared with bone marrow (BM) autografts. Higher doses of CD34+ peripheral blood~     stem cells (PBSCs) are collected to ensure engraftment and possibly reduce the incidence of~     treatment-related mortality (TRM). Although there is a threshold CD34+ cell dose below which~     engraftment is delayed in AML, the positive linear correlation of the number of CD34+ cells~     and kinetics of engraftment reaches a limit above which an increase in the number of~     progenitor cells does not provide any additional benefit. Relapse has been shown to be higher~     and survival shorter for those who receive the highest CD34+ PB doses. Although highly active~     against the leukemia bulk, intensive chemotherapy often spares the hardiest leukemia stem~     cells (LSCs) responsible for relapse. Detection of minimal residual disease (MRD) in~     autologous PBSC products may reflect inadequate in vivo purging, at least in part responsible~     for relapse. Although representing a heterogeneous cell population including both normal and~     leukemia cells, and despite that recent data have challenged the CD34+ CD38- phenotype of~     LSCs in AML, the CD34+ CD38- cell population generally remains considered enriched for LSCs.~      In this setting, MRD remaining during morphological complete remission (CR) should be~     relatively enriched in CD34+ CD38- leukemia cells, and their persistence after CR achievement~     should correlate with disease recurrence. This was investigated in a cohort of 123 patients~     with AML following apheresis procedures after CR achievement. The investigators also studied~     the impact of the infused dose of subpopulations of CD34+ PB cells on the outcome of a subset~     of 71 patients who further underwent autologous PBSCT.~   "
55381|NCT02842099|"~     The study is a prospective, randomized phase II clinical trial, to compare the efficacy and~     safety profiles of standard chemotherapy versus standard chemotherapy followed by~     capecitabine as prolonged postoperative adjuvant treatment for breast cancer patients.~   "
55382|NCT02842086|"~     The primary objective of this study is to assess the rates of HIV-1 seroconversion in Men~     (MSM) and transgender women (TGW) who have sex with men and who are administered daily~     emtricitabine/tenofovir alafenamide (F/TAF) or emtricitabine/tenofovir DF (F/TDF) with a~     minimum follow-up of 48 weeks and at least 50% of participants have 96 weeks of follow-up.~   "
55383|NCT02842073|"~     This is an open-label Phase IIa pilot study of the tolerability and effects on binge drinking~     of bupropion and naltrexone for binge drinkers and assess cortical adaptation to tactile~     stimuli in subjects with binge drinking.~   "
55384|NCT02842060|"~     This study uses an interactive design and development process to develop tailored messages~     that align YMSM's relationship experiences and desires with HIV prevention strategies. The~     study includes a tailored online prevention, intervention, as well as an attention control~     non--tailored HIV prevention (NTHP) comparison intervention. The pilot RCT will compare the~     intervention (N=120) to NTHP (N=60) to assess intervention feasibility and acceptability, and~     gather preliminary behavioral data to inform a subsequent application. Follow-up assessments~     will be collected at thirty (30), sixty (60), and ninety (90) days post-intervention.~   "
55385|NCT02842047|"~     Caregivers of persons with cancer may face many challenges as they support and care for a~     person receiving treatment. Sometimes having to help make treatment decisions for a patient~     can cause distress for caregivers. The purpose of this study is to evaluate 2 different~     electronic approaches to providing support for a caregiver. One group will have access to an~     on-line program with videos, providing education on decision making strategies for caregivers~     of patients with cancer, to watch and a daily meditation application and the other group will~     have access to the daily meditation application. Investigators will randomly assign~     participants to each group.~   "
55386|NCT02842034|"~     This study is to determine whether high frequency repetitive transcranial magnetic~     stimulation (rTMS) is effective in the treatment of negative symptoms in schizophrenia~     patients~   "
55387|NCT02842021|"~     To assess the efficacy and safety of a combination product S2G6T-1 compared to its monads and~     vehicle, applied twice daily for 7 days, in the treatment of symptomatic inflammatory~     interdigital tinea pedis in subjects 12 years of age and older. The results of this study~     will be utilized to perform power calculations for the Phase 3 pivotal trials.~   "
55388|NCT02842008|"~     Shoulder pain is the most common symptom of physical dysfunction in wheelchair basketball~     players. About the 85% of this population had shoulder pain in some moment of their life.~     Some studies suggest that exercise is an important tool as an element to treat and prevent~     shoulder injuries. For that reason, an intervention program would be a useful tool for~     prevent shoulder injuries in this population.~      The purpose of this study is determine the effects of therapeutic exercise program wheelchair~     basketball players, in order to prevent shoulder injuries.~   "
55389|NCT02841995|"~     This study is being conducted to evaluate the safety, tolerability, and activity of KD025 in~     adult subjects with chronic Graft versus Host Disease (cGVHD).~   "
55390|NCT02841982|"~     This prospective, randomized study,control study aims to compare the analgesic effect,opioids~     consumption,quality of recovery,length of hospital stay and incidence of chronic pain,et al.~     between single-injection QLB(quadratus lumborum block) , single-injection QLB +continuous QLB~     and intravenous patient-controlled analgesia (IPCA) alone in patients undergoing laparoscopic~     renal surgeries.~   "
55391|NCT02841969|"~     More patients with diabetes mellitus have led to increasing rates of chronic non-healing~     wounds. These wounds are colonised with pathogens, including multi-drug resistant organisms.~     Despite repeated courses of antibiotics subsequent management is difficult due to~     devascularisation of surrounding tissues and healing failures. Ultimately, patients may~     require amputation. Electrolysed water is a novel antiseptic produced by passing an electric~     current through a mixture of tap water and salt. Microbiocidal activity is due to the~     presence of hypochlorous acid at neutral Ph. Irrigation of chronic wounds with electrolysed~     water reduces bacterial load and appears to encourage wound healing. Following an encouraging~     pilot study, we propose to compare electrolysed water against conventional management for~     diabetic patients with non-healing foot ulcers. Adult diabetics with chronic ulcers attending~     podiatry at Hairmyres Hospital will be recruited to receive regular debridement and~     irrigation of wounds using either in-use product (Prontosan™) or electrolysed water as part~     of a prospective randomised controlled trial. Strict enrolment criteria will be applied, with~     regular clinical assessment and microbiological screening. Lesions present for >6 weeks and~     >2cm will be photographed at trial entry and graded using standardised criteria. Wounds will~     be monitored for at least 12 weeks (max. 20), with primary composite end-point defined as~     complete healing; >50% healing of initial lesion; and/or avoidance of surgical intervention.~     Secondary endpoints are surgical intervention, including debridement or amputation;~     antibiotic therapy; and/or patient death. The main objective is to compare rapidity of wound~     healing using either in-use product or electrolysed water. Improved healing could potentially~     benefit patients who might otherwise progress to amputation. We will also monitor~     antimicrobial consumption in study patients throughout the trial. A final objective is to~     cost the use of electrolysed water vs cost of Prontosan in the routine management of diabetic~     foot ulcers.~   "
55392|NCT02841956|"~     Reducing Duration of Untreated Psychosis (DUP) is a primary goal for improving long-term~     outcomes in young people with a first episode of psychosis (FEP). The standard of FEP care~     within the US focuses on targeted provider education regarding signs and symptoms of early~     psychosis to motivate patient referrals to FEP services, followed by initiation of services~     within largely clinic-based settings Experience at the Early Diagnosis and Preventive~     Treatment (EDAPT) FEP specialty program at U.C. Davis in Sacramento has identified two~     important bottlenecks to reducing DUP, consistent with reports in the literature from other~     FEP clinics. These are 1) delays in the identification of psychotic symptoms by referral~     sources, and 2) delays or disruptions of patient engagement in specialty FEP care. Building~     upon a comprehensive and established referral network of 20 sites across the Sacramento area~     (schools/universities, ER/inpatient hospitals, outpatient mental health, primary care), the~     investigators will address delays in patient identification and engagement using a two-phase,~     cluster randomized design. The investigators will consecutively test the impact of two~     interventions to reduce DUP, defined in this RFA as time from first onset of psychotic~     symptoms to engagement in FEP specialty care. To address identification delays, the~     investigators will examine the use of standard targeted provider education plus novel~     technology-enhanced screening compared to standard targeted provider education alone, testing~     the hypothesis that the education plus technology-enhanced screening will identify more~     patients, earlier in their illness. To address engagement delays, the investigators will~     compare the use of a mobile community-based, telepsychiatry-enhanced engagement team to~     standard clinic-based procedures for intake, engagement and initiation of treatment, to test~     the hypothesis that the mobile approach facilitates earlier and more stable engagement,~     thereby reducing DUP. The proposed work will provide new specific evidence-based practices~     for reducing DUP and improving outcomes through specialty care of individuals with a first~     episode of psychosis.~   "
55393|NCT02841943|"~     Study Design: Prospective observational study~      Study Location: Liverpool Hospital Intensive Care Unit, South Western Sydney Local Health~     District, Sydney, Australia.~      Target study size: 100 patients~      Ethics: Approved by the local Human Research and Ethics Council (HREC) at Liverpool Hospital~     (LPOOL) as a Low Negligible Risk (LNR) project [HREC/LNR/14/LPOOL/295, HREC/LNR/15/LPOOL47,~     HREC/LNR/14/LPOOL/150]~      Participants: Post cardiac surgical patients admitted to the Intensive Care Unit between~     March-October 2016~      Aims:~        1. to determine the descriptive and predictive value of variables (outlined below) related~          to oxygen delivery/consumption in regards to the effects of intravascular volume~          expansion~        2. to assess correlations between central and peripheral variables (outlined below)~          relevant to oxygen delivery/consumption~        3. to assess correlations between a set of variables (outline below) and patient centred~          outcomes in ICU and in hospital~      Main variables collected:~        1. Tissue oxygen saturation by peripheral Near-Infrared Spectroscopy (NIRS)~        2. Common carotid arterial Doppler~        3. Arterial/mixed venous/central venous blood gas analyses~        4. Haemodynamic parameters~        5. Organ support measures~      Data collection time points:~        1. ICU admission (within 30 minutes)~        2. Before administration of a fluid bolus~        3. After administration of a fluid bolus~        4. 6 hours after ICU admission~        5. Morning of first postoperative day (12-24 hours)~      Outcome measures:~        1. the response to intravascular volume expansion~        2. ICU mortality, morbidity and length of stay and hospital mortality and length of stay~      Data analysis:~        1. Clinical data are collected bedside using an electronic case record form~        2. Descriptive statistics~        3. Paired and unpaired comparative~        4. Correlative and predictive statistics~   "
55394|NCT02841930|"~     The ActionHealthNYC program is a year-long demonstration program to improve access to high~     quality health care for NYC resident immigrants who do not qualify for public insurance with~     incomes at or below 200% of the Federal Poverty Level (FPL). The purpose of this study is to~     determine whether improved access and care coordination services provided through the~     ActionHealth NYC program allows participants to have easier access to healthcare~     (particularly primary care and preventive services) than non-participants.~   "
55395|NCT02841917|"~     Surgical aortic valve replacement (SVAR) is currently the 'Gold Standard' therapy for~     patients with severe symptomatic aortic stenosis (AS). Approximately 30-50% of patients with~     severe AS are deemed inoperable due to comorbidities such as severe respiratory disease,~     chronic renal disease and peripheral vascular disease. Transcatheter aortic valve replacement~     (TAVR) has emerged as a novel therapeutic modality for inoperable patients and an effective~     alternative to SAVR in selected high and intermediate-risk patients. Myocardial ischemia and~     reperfusion injury (MRI), mediated by reactive oxygen species (ROS), related to~     cardiopulmonary bypass has been linked to adverse clinical outcomes following cardiac~     surgery. In contrast to SAVR, transcatheter deployment of aortic prostheses requires shorter~     time of ischemia and hypotension and may be associated with less ROS mediated MRI.~     Inflammatory responses and reperfusion injury following TAVR have not been previously~     described nor compared to SAVR. The aim of this study is therefore to compare the oxidative~     stress response in patients with isolated severe symptomatic AS undergoing SAVR or TAVR and~     determine whether it correlates with clinical outcomes.~   "
55396|NCT02841904|"~     This study evaluates the accuracy of Confocal Laser Endomicroscopy (CLE) in the diagnostic of~     non-invasive flat and exophytic bladder neoplasia. CLE results are compared to histopathology~     results.~   "
55397|NCT02841891|"~     The Cohera Sylys® Surgical Sealant study is a prospective, randomized, controlled,~     multicenter clinical study comparing standard anastomosis closure technique (Control) to~     standard closure technique plus Sylys® Surgical Sealant (Test) in patients undergoing a~     colectomy procedure with a stapled anastomosis.~   "
55398|NCT02841878|"~     Irritable bowel syndrome (IBS) profoundly affects the quality of life. Mucosal~     micro-inflammation, epithelial permeability disorder and proteases activity increase have~     been demonstrated in the patients' gastrointestinal tract. Protease activity increase could~     be subjected to a genetic determinism (decrease in proteases inhibitors genes expression).~     Objectives: 1/ To study relations between proteases activity (in stool and colonic biopsies~     supernatants), proteases inhibitors genes expression and mucosal cellular infiltrate (IBS~     patients and healthy subjects). 2/ Establishing a correlation between proteases activity,~     mucosal micro-inflammation and symptoms. 3/ To evaluate proteases inhibitors therapeutic~     potential. Expected results: 1/ Decreased expression of proteases inhibitors genes in~     subjects with IBS. 2/ Correlation of symptoms with proteases activity intensity. 3/~     Demonstration of restorative potential of proteases inhibitors.~   "
55399|NCT02841865|"~     The Response Evaluation Criteria in Solid Tumors (RECIST), based on differences in tumor~     size, has been considered as a reproducible method that facilitates not only the measurement~     of the mass but the evaluation of response to given treatments; while classic chemotherapy~     induces a reduction of the tumor, new target therapies frequently produce the stabilization~     of the disease or a delayed progression. These new therapeutic alternatives have shade light~     on the limitations of the RECIST criteria, since the response to these type of treatments are~     basically associated with changes on the radiological characteristics of the tumor, as well~     as other findings in functional imaging.~      This study is aimed to compare the response rates according both Choi and RECIST criteria.~   "
55444|NCT02841267|"~     The investigational product PF 06252616, a humanized anti myostatin monoclonal antibody that~     neutralizes myostatin (GDF8) is in development for the treatment of Limb Girdle Muscular~     Dystrophy 2I (LGMD2I) to preserve and/or improve muscle function.~      This study will provide the clinical assessment of the safety, tolerability, Pharmacokinetics~     and Pharmacodynamics of PF 06252616 following repeat IV doses in ambulatory adults with~     LGMD2I.~   "
85846|NCT02443376|"~     Central blood pressure and pulse wave velocity were measured using a Complior Analyse device~     before and immediately after the end of the dialysis session.~   "
55400|NCT02841852|"~     Proton pump inhibitors (PPIs) are one of the most frequently prescribed classes of drugs in~     the world and the most effective drugs available to reduce gastric acid secretion. However,~     studies have shown that PPIs are not always prescribed with a clear indication. Indeed,~     between 25% and 86% of older individuals taking a PPI have been overprescribed these~     medications. In older patients, overprescribing of a PPI is associated with increases in~     morbidity, adverse drug events, hospitalization, and mortality. The hypothesis is that~     overprescription of PPIs is associated with the individual multimorbidities in older patients~     evaluated using the multimorbidities group criteria included in the CIRS. The aim of the~     present study was to establish a relationship between overprescribing of PPIs and~     multimorbidities in older patients.~   "
55401|NCT02841839|"~     To identify a sampling method for collecting subgingival plaque~   "
55402|NCT02841826|"~     The intrauterine devices (IUDs) are a safe, reliable, long-acting and reversible~     contraceptive method. It is also sound safe and cheap contraceptive methods available and is~     nearly maintenance free for up to 10 years.~      The fear and the pain associated with IUDs insertion consider barriers to using this~     contraception method, this is because that the mucosal lining of female genital tract is~     highly sensitive to touch and pain. However; most of small procedures done in this sensitive~     area are performed without analgesia.~      The pain during IUDs insertion is due to application of the tenaculum , traction of the~     cervical canal, passing the uterine sound, insertion of the IUDs through the cervix, and~     irritation of the endometrial lining by the IUDs.~   "
55403|NCT02841813|"~     The incidence of preterm birth increases annually. Premature delivery has become the leading~     cause of neonatal illness and death. For the survived premature babies, the incidence of~     sequelae is also higher than the full-term babies, which brings a heavy burden to a family~     and society. Preterm birth has become the important factor affecting the quality of births.~     The occurrence of premature birth is the outcome of combined action of genetic and~     environmental factors. However, its etiology is not clear. Recent studies have shown that the~     risk of preterm birth is associated with dietary factors. Choline is an essential nutrient~     for human health and it plays an important role in the growth and development of fetuses and~     neonates. The investigators previously found that serum levels of free choline in preterm~     mothers were lower than those in normal mothers with full-term birth. Serum levels of free~     choline also reduced in preterms after receiving parenteral nutrition (PN). However, the~     relationships between choline and preterm birth is not clear. Therefore, this study is aimed~     to explore the effect of choline intake during pregnancy and genetic polymorphisms on the~     risk of preterm birth and on the clinical outcomes in preterms receiving total PN therapy.~     Healthy Chinese pregnant women with their healthy term infants will be recruited as the~     control group, while Chinese women with preterm delivery and their preterm infants will be~     recruited as the preterm group. Dietary choline intake during pregnancy will be evaluated by~     semi-quantitative food frequency questionnaire and 24-h dietary recall questionnaire. Gene~     polymorphisms in the key enzymes of choline metabolism will be identified among the~     participated women and neonates through Real-time polymerase chain reaction. Choline and its~     related metabolites will be assayed using high performance liquid chromatography combined~     with mass spectrometry among all mothers and preterms before and after 7-days PN treatment.~     The influence of genetic risk factors and metabolic changes of choline on the physical and~     mental development of preterms will be evaluated. The results of this study will contribute~     to a comprehensive understanding of the role of choline and the relative gene polymorphisms~     on the risk of preterm birth, which will be helpful for estimating the high risk in advance.~     The results will also provide the scientific evidences to establish the personalized amount~     of choline intake among women and infants, optimize nutrition support for pregnant women and~     preterms, and promote better prenatal and postnatal care.~   "
55404|NCT02841800|"~     Only a small proportion of patients with biliary obstruction caused by hepatopancreatobiliary~     malignancies are suitable for surgical resection. Therefore, most patients with malignant~     biliary obstruction will need palliation of their obstructive jaundice to relieve the~     symptoms and prevent life threatening complications such as biliary sepsis. The endoscopic or~     percutaneous/transhepatic routes, such as endoscopic retrograde cholangiopancreatography~     (ERCP) and percutaneous transhepatic cholangiography (PTC), and stents are accepted~     approaches for the relief of jaundice in malignant biliary obstruction. Improvement in the~     bilirubin level is also essential before palliative chemotherapy is considered in these~     patients. However, tumor ingrowth still remains a major cause of obstruction. In this trial,~     the investigators will use HabibTM EndoHPB (EMcision Ltd., UK) catheter which was used for~     the endobiliary radiofrequency ablation (RFA) treatment as a form of neoadjuvant therapy in~     hepatopancreatobiliary adenocarcinoma.~   "
55405|NCT02841787|"~     The goal of this field trial is to tailor and test a web-based intervention in adults 65~     years of age or older. Two versions of the web-based intervention have been created and will~     be tested--one with an online social network and one without an online social network. The~     purpose of this study is to: pilot a novel intervention, examine methods to improve adherence~     to web-based interventions (e.g., peer network); collect data on feasibility, acceptability,~     and efficacy of an web-based intervention for late life depression; and ultimately, to~     overcome the numerous barriers to treating depression in later life.~   "
55406|NCT02841774|"~     HILLCLIMBER is a randomized, controlled, open-label phase II trial of moderate dose statin~     therapy (pravastatin 40mg daily) versus high-dose statin therapy (rosuvastatin 20-40mg daily)~     in HIV-infected persons taking antiretroviral therapy (ART) who have coronary heart disease~     (CHD).~   "
55407|NCT02841761|"~     The purpose of this study is to evaluate the effect of ACT-132577 on the pharmacokinetics of~     midazolam and 1-hydroxy midazolam and to evaluate the safety and tolerability of ACT-132577~     when administered alone and in combination with midazolam.~   "
55408|NCT02841748|"~     A placebo-controlled, randomized study using adjuvant pembrolizumab treatment for one year in~     order to potentially improve progression free survival in a squamous cell carcinoma of the~     head and neck cohort at high-risk for recurrence.~   "
55409|NCT02841735|"~     It is important to explore use of technology to reduce drinking. The purpose of this research~     study is to compare different types of mobile technology for their effects on alcohol~     drinking and ratings of usability among young adults.This study will be conducted in four~     phases: a web-based screening assessment; brief appointment on the day of the alcohol~     drinking session; alcohol drinking session; and a follow-up appointment. Participation in~     this study will last approximately two months.~   "
55445|NCT02841254|"~     Meningitis are serious infections. Evidenced by high rates of mortality and sequelae.~     However, these diseases have a relatively small impact. Also physician services Home~     Emergencies they must be vigilant, alert, for clinical signs to be suspected meningitis.~     Indeed, it is only after this essential clinical milestone that will be carried out a lumbar~     puncture which will confirm the diagnosis and to quickly begin treatment.~      Unfortunately, if recent studies can improve the therapeutic management of patients with~     meningitis, no study was interested in yet fundamental step of diagnosis.~      It seems therefore necessary to achieve a prospective clinical study to reassess the adequacy~     of the clinical signs in the diagnosis of meningitis. The ideal would be to achieve a~     predictive clinical score of the presence or absence of meningitis.~   "
55410|NCT02841722|"~     The anti-cancer cytotoxic chemotherapy is often the cause of neutropenia of grade IV or~     febrile neutropenia. Those neutropenia, in addition to being a comorbidity factor, result in~     dose reductions and/or temporary or permanent stop of chemotherapy, thus impacting clinical~     response. To avoid those episodes, or to shorten the duration and reduce the associated risk,~     administration of Granulocyte Colony Stimulating Factor (G-CSF) is recommended. Recombinant~     G-CSF reproduces the physiological effects of endogenous G-CSF by increasing the~     proliferation of granulocytes progenitors. Different forms of G-CSF are available: daily~     administration (such as filgrastim, lenograstim) and a single administration (pegfilgrastim).~      Various international learned societies offer recommendations for primary care, secondary or~     curative neutropenia induced by chemotherapy based on G-CSF. However, guidance on the ideal~     time for the administration of growth factors and duration of administration are not very~     clear. If it seems clear that the treatment should not be initiated within the first 24 hours~     following administration of chemotherapy, summaries of the characteristics of different~     products do not provide evidence to optimize the administration day depending on the kinetics~     evolution of neutrophils. In addition, no information is given as to the choice of a~     formulation with respect to the other.~      The pilot study the investigator propose aims to model the effect of exogenous G-CSF on the~     evolution of neutrophil function of time and explain the pharmacodynamic variability during~     the administration of chemotherapy based on eribulin. The description of the evolution of~     neutrophils when growth factors are administered give the opportunity to streamline~     administration regimens of these factors and to provide guidance on the circumstances in~     which they should or should not be given while weekly chemotherapy.~      Expected benefits and foreseeable risks With the exception of surplus withdrawals during the~     first 2 cycles of treatment, this study will have no impact on the care of patients.~   "
55411|NCT02841709|"~     The primary objective of this study is to assess the effect of ACT-541468 on a measure of~     sleep maintenance (Wake after Sleep Onset or WASO) by polysomnography in elderly subjects~     with insomnia disorder.~   "
55412|NCT02841696|"~     Hypertension is a major cardiovascular risk factor. Heart failure is one of its main~     complications but the factors that influence its development are still insufficiently known.~     The primary objective is to determine associated factors to the occurrence of left~     ventricular (LV) systolic dysfunction assessed by an alteration of the Global Longitudinal~     Strain (GLS) after more than the years of hypertension. The secondary objective is to~     estimate the prevalence of LV systolic dysfunction in a cohort of hypertensive people~     followed for over 10 years and formulate pathophysiological hypotheses on the development of~     this heart disease.~   "
55413|NCT02841683|"~     Introduction - A national smoking cessation E-intervention, called Tabac Info Service (TIS),~     was developed in France to provide an adapted web and mobile application support to smoking~     cessation for all adults smokers, with or without chronic diseases, who want to stop smoking.~     This paper presents the study protocol of the evaluation of the program. The primary~     objective of this evaluation is to assess the efficacy and efficacy conditions of eTIS. The~     secondary objectives are to 1) describe efficacy variations in regard to user~     characteristics, 2) analyze mechanisms and efficacy conditions of eTIS, through variations of~     use, social or environmental contextual factors likely to influence the efficacy of eTIS, and~     the behavior change techniques (BCTs).~      Methods and analyses - The study design is a two-arm pragmatic randomized controlled trial~     including a process evaluation with at least 3000 participants randomized to the intervention~     or to the control arm (current practices presented in a non-interactive website). Inclusion~     criteria are: Adults, Smokers with an information and consent form completed, Getting a~     smartphone and using mobile applications, wanting stop to smoking in short, medium or long~     terms. The exclusion criterion is the refusal to participate in the study. The primary~     outcome is the point prevalence abstinence of 7 days at 6 months later. The secondary~     outcomes are: the point prevalence abstinence of 24 h at 3 months later, the point prevalence~     abstinence of 30 days at 12 months later, number of quit attempts during the study,~     progression of stages within the program (changes and duration in each stage). Data will be~     analyzed in Intention to treat (main analyze) and per protocol ways. A logistic regression~     will be carried out to estimate an OR [95% confidence interval] for efficacy. A multivariate~     multilevel analysis will explore the influence of patients' characteristics, social and~     environmental context, conditions of use and behavior change techniques on results.~      Dissemination -The findings of this study will allow us to understand and characterize the~     efficacy of eTIS, and conditions of its efficacy, underlining psychological, sociological,~     environmental and contextual factors, which could influence the efficacy of this type of~     intervention on smokers. These findings will be disseminated through peer-reviewed journals,~     national and international conference presentations and public events.~   "
55414|NCT02841670|"~     This is a monocentric, longitudinal, prospective, observational post-market follow-up study.~      30 patients with a cataract will receive an InFo - Instant Focus © lens implant. After the~     cataract procedure, data collection will take place during visits planned by the physician as~     part of normal follow-up.~      Patients with cataract will be recruited from the clinic by the investigator based on the~     inclusion and exclusion criteria.~      The patient will be followed up after one day, one week, one month, six months, one year and~     three years post-op. An interim analysis will be performed with one-year clinical results.~      The main objective of the study is to evaluate is to evaluate efficacy and long-term safety~     for the InFo - Instant Focus © lens.~   "
55415|NCT02841657|"~     -  To compare surgical and oncological outcomes in patients underwent to colorectal~          resection with 3D vs 2D laparoscopic technique.~        -  To evaluate the visual overload in surgeons using 3D laparoscopic technique.~   "
55416|NCT02841644|"~     For the last 70 years, orthopaedic dogma has dictated that all injuries that penetrate the~     joint capsule require formal irrigation and debridement in the operating room to minimize the~     risk of developing septic complications. The literature supporting this practice is sparse~     and stems primarily from wartime injuries that may not be generalizable to the smaller, less~     contaminated arthrotomies seen in the civilian population. Despite the classical teaching of~     all traumatic arthrotomies requiring irrigation, debridement, and closure in the operating~     room, numerous surgeons around the country are beginning to treat small traumatic~     arthrotomies without surgery. The purpose of this study is to evaluate the cost of treatment~     as well as incidence of adverse events, such as the development of septic arthritis, in~     patients undergoing operative and non-operative treatment of traumatic arthrotomies.~   "
55417|NCT02841631|"~     Human Papilloma Virus (HPV) has been shown to be a cause of Head & Neck Squamous Cell~     Carcinoma (HNSCC) and the majority of current studies focus on what is happening in patients~     with a HPV HNSCC. But there is limited investigation into HPV infection in the oropharynx of~     patients who do not have HNSCC. The current incidence of oral HPV infection is not known in~     the general population locally and there is also limited information on what particular~     localities within the mouth that patients' harbour HPV infection what strains are present and~     if there are any differences in viral load.~      Therefore the aim of this project is to investigate within patients that undergo~     tonsillectomies the rate of HPV infection in tonsils to determine the amount of HPV present~     within the community.~   "
55418|NCT02841618|"~     The purpose of this study is to understand how consuming healthy cookies every day for two~     weeks will affect different types of fat in the blood. Specifically, the overall goal of this~     study is to find out if the healthy cookies can increase a polyunsaturated fat called~     linoleic acid in plasma, red blood cells and white blood cells.~   "
55446|NCT02841241|"~     This is a prospective, single arm, roll-in study of esmolol infusion for patients with~     septic shock with persistent tachycardia after adequate intravenous volume expansion. The~     study will evaluate the adequacy and efficiency of study protocols for the anticipated, main~     ECASSS study, which will have a separate entry in clinicaltrials.gov.~   "
55419|NCT02841605|"~     The close homology between the central and enteric nervous systems suggests that a disease~     process affecting the central nervous system could also involve its enteric counterpart. The~     investigators have recently shown in that the enteric neurons can be readily analyzed using~     routine colonic biopsies. This led us to propose that the enteric nervous system could~     represent a unique window to assess the neuropathology in living patients with a~     neurodegenerative disorder. The investigators have already used this approach to show that~     Parkinson's disease pathology was recapitulated in a single colonic biopsy. By contrast to~     Parkinson's disease, the detection of Alzheimer's disease (AD) pathology in the enteric~     neurons has so far failed. This may be due to the low number of human tissue samples in~     addition to the low sensitivity of the immunohistochemical methods that were used. The aim of~     the current research project will be therefore to reevaluate AD pathology in a large number~     of human colonic samples using both a morphological and biochemical approach .~      The enteric nervous system could represent a unique window to assess the neuropathology in~     living patients with AD. This might open the way to the development of novel AD biomarkers~     that will directly assess the neuropathological process.~      Main Aim : To Analyze the presence of beta-amyloid pathology in the enteric nervous system~     (ENS) in AD patients~      Secondary Aim(s):~        1. To analyze and describe the presence of tau in the enteric nervous system (ENS) in AD~          patients~        2. To assess neuronal loss in submucosal tissue in AD patients.~        3. To examine Glia cells in the enteric nervous system in AD patients..~   "
55420|NCT02841592|"~     This crossover investigation enrolls healthy volunteers and compares the exhaled oxygen~     content (FeO2) between the non-rebreather mask at the flush rate and a bag-valve-mask device~     at the flush rate, used with active positive pressure assistance.~   "
55421|NCT02841579|"~     The primary goal is to evaluate the efficacy of osimertinib (AZD9291), in terms of the~     objective response rate in patients with advanced non-squamous NSCLC with EGFR mutations and~     the EGFR T790M mutation at diagnosis as defined by RECIST 1.1 criteria.~      Safety and efficacy will also be measured.~   "
55422|NCT02841566|"~     The purpose of this study is to to explore the link between materialism and addiction to~     gambling and money~   "
55423|NCT02841553|"~     In this study, the investigators hypothesize that studying monogenic variants with strong~     effect associated with severe insulin deficiency of Wolfram syndrome will provide important~     insights into the more complex type 1 and type 2 diabetes mellitus.~      Aim 1. Establish and maintain a registry of patients with Wolfram syndrome. An Internet based~     registry will be employed to enroll participants with the clinical diagnosis of Wolfram~     syndrome (insulin dependent DM and bilateral OA). Clinical information regarding age of~     diagnosis and progression of the disease will be collated and analyzed to better define its~     natural history, along with potential metabolic phenotypes such as glucose intolerance of~     heterozygous parents and unaffected sibs.~      If not already completed, blood for WFS1 sequence analysis will be obtained on the~     participants (parents and sibs also for control purposes) and sent to a CLIA certified lab to~     define the mutation. This information will benefit patient families and referring physicians~     by providing a genetic diagnosis and where indicated. The Wolfram Syndrome Registry will~     foster international collaborations to more efficiently and systematically collect Wolfram~     syndrome patients and their clinical and experimental data.~   "
55424|NCT02841540|"~     This study will include a Phase 1 dose-finding portion (Cohorts A and B) and a four-arm~     expansion portion. The primary objectives of the study are to determine the maximum tolerated~     dose (MTD) and recommended Phase 2 dose (RP2D) of H3B-8800 administered orally in~     participants with Myelodysplastic Syndromes (MDS), Acute Myeloid Leukemia (AML), or Chronic~     Myelomonocytic Leukemia (CMML) and to assess the safety and tolerability of H3B-8800 as a~     single agent administered orally once daily on a 5 days on/9 days off repeated dosing~     schedule in 28-day cycles in participants with MDS, AML, or CMML.~   "
55425|NCT02841527|"~     Obesity is an increasing health problem in the United Kingdom (UK) and is predicted to~     worsen.~      In the UK and worldwide the three most commonly performed operations are laparoscopic~     adjustable gastric banding ('BAND surgery'), laparoscopic gastric bypass ('BYPASS') and~     laparoscopic sleeve gastrectomy ('SLEEVE'). All lead to weight loss, but they are associated~     with different problems. This study (BYBANDSLEEVE) is a randomised trial with a target~     recruitment of 1341 patients in eleven hospitals and its aim is to compare the effectiveness,~     cost effectiveness and acceptability of BAND, BYPASS and SLEEVE surgery.~   "
55426|NCT02841514|"~     Study title: The Efficacy and Safety of tooth bleaching procedure using Y10 Whitening~     toothpaste and RF current~      The Device: The Brighttonix Y10 Tooth Whitening system is indicated for use in painless~     non-invasive tooth whitening treatments.~      Design: Single center, randomized, controlled, double blind, two-arm, prospective clinical~     study.~      Follow up visits at 7 days (phone visit), 12 weeks and 26 weeks.~   "
55427|NCT02841501|"~     This is a prospective case-control physiopathological study, which main objective is to~     determine the genetic host factors predisposing to candidemia. Secondary objectives are to~     develop new diagnosis tools using the biological collection, to describe and update~     epidemiology, to analyse the influence of genetic polymorphisms on prognosis.~   "
55428|NCT02841488|"~     This project is one of four components of a thematic project that aims to evaluate the use of~     ultrasound in regional blocks, called Use of ultrasound in regional blocks and injections~     for the treatment of acute and chronic pain.~      It will evaluate quantitative and qualitative control of ischemic pain in the lower limbs in~     patients with peripheral arterial occlusive disease through continuous sciatic nerve block by~     perineural catheter, popliteal approach, compared to systemic analgesia based on opioids.~   "
55447|NCT02841228|"~     Lung cancer is one of the most common cancer and the leading causes of cancer death in~     worldwide. Approximately 80% of NSCLC were inoperable. The prognosis of patients with~     LA-NSCLC remains disappointing. Investigators hypothesized that use of simultaneous~     integrated boost intensity modulated radiotherapy (SIB-IMRT) technology can safety increasing~     the radiation dose and benefit for inoperable NSCLC patients.~   "
55450|NCT02841189|"~     This is a single center trial to evaluate the performance of the King Vision video~     laryngoscope in pediatric patients between the ages of one month and 10 years of age. If the~     performance is satisfactory, this device may become a standard laryngoscope for tracheal~     intubation in elective and emergent tracheal intubations.~   "
55429|NCT02841475|"~     Atrial fibrillation (AF) is a common condition whose prevalence increases with advancing age~     . One of the main complications of this arrhythmia is the occurrence of systemic~     thromboembolism, the first of which the occurrence of cerebrovascular accident (CVA) . The~     advanced age itself is an independent risk factor for occurrence of stroke in the context of~     AF , evidenced by the score awarded to the age over 75 years in the risk estimate~     thromboembolism in the score CHA2DS2-Vasc . Making the elderly a priority target for the~     prevention of thromboembolism, both because of the increased thromboembolic risk and~     prevalence of AF in this population. For many years, vitamin K antagonists (VKA) have proven~     their effectiveness in this context . But the effectiveness and safety of thromboembolism~     prevention by anti-vitamin K treatment involves maintaining the INR (International Normalized~     Ratio) in the therapeutic range. Indeed occurred of a thromboembolic or haemorrhagic adverse~     event directly correlates to having an INR outside the therapeutic range and maintaining the~     INR in the therapeutic range is subject to many variations inter- and intra-individual. They~     include, genetic factors , food , drug interactions , as well as disease processes . Or one~     of the elderly characteristics is the coexistence of multiple pathological processes or~     comorbidities . The supposed interaction between comorbidities and variability of INR has~     been little studied: Only a few studies have examined the factors associated with the~     stability of the INR and unstable . The identification of patients at risk of instability INR~     yet allow clinicians greater vigilance and better identification of patients for whom the~     initiation of treatment with vitamin K does not appear the best therapeutic strategy.~      Our study seeks to determine whether comorbidity, assessed by the Charlson comorbidity index,~     are associated with instability of the INR, among more than 80 years for patients treated~     with AVK atrial fibrillation.~   "
55430|NCT02841462|"~     The overall objective of this trial is to explore the dose-tolerance (safety) and~     dose-response (efficacy) of single 3-minute intra-bursal perfusions of a physiological saline~     solution at increasing temperatures.~   "
55431|NCT02841449|"~     The aim of this study is to investigate whether hydration status affects blood sugar control~     and appetite regulation. In order to do this, participants will undergo a monitoring phase~     whereby their weight, diet and physical activity are monitored, followed by a dehydration~     protocol involving fluid restriction and sitting in a heat tent. In one arm of the trial,~     participants will remain dehydrated for the remainder of the day (i.e. after the heat tent)~     by having their fluid intake restricted, and in the other arm of the trial, participants will~     be rehydrated by consuming the necessary amount of plain water. All participants will undergo~     both arms of the trial, the order of which will be chosen randomly.~      Several measures will be taken throughout the trial. Before participants go into the heat~     tent, they will provide a urine sample (for baseline hydration status as indicated by urine~     osmolality), a blood sample (for glucose, insulin, arginine vasopressin,/copeptin, ghrelin~     and serum osmolality and plasma volume), and have a peripheral quantitative computer~     tomography scan of their thigh to indicate muscle size. On the day proceeding the heat tent,~     participants will have these measures repeated, along with metabolic rate before consuming a~     75 g glucose drink, followed by 15 minutely blood samples and hourly metabolic rate measures~     for 120 minutes (i.e. an oral glucose tolerance test; OGTT). Following this, participants~     will be presented with a large bowl of pasta and sauce and will be instructed to eat until~     satisfied (maximum 30 min). Blood samples will be taken every 10 minutes for 60 minutes~     following the meal.~      Participants also have the option to opt-in to have a muscle biopsy taken. This will be taken~     before and ~120 minutes after the glucose drink.~   "
55432|NCT02841436|"~     Pancreatic cancers is one the most important malignancies with highest mortality in the~     world. The prognosis of these patients is very poor. Although some patients with~     early-diagnosed disease could receive surgical intervention, a majority (70%to 80%) of~     patients present with locally advanced or metastatic status are inoperable. Patients in this~     late status usually are recommended to receive palliative bypass operation such as~     choledochojejunostomy and/or gastrojejunostomy and palliative radiotherapy for the pancreatic~     cancer. Radiofrequency ablation (RFA) used to be expected an alternative therapy. However,~     the main drawback of RFA is its side effect to damage adjacent structure such as bile duct,~     and the tumors located adjacent to vessels could not be ablated well.~   "
55433|NCT02841423|"~     Background: Postoperative cognitive dysfunction (POCD) in elderly patients after noncardiac~     surgery is a common problem.~      Therefore,this study was designed to assess POCD after closed-loop coadministration of~     propofol and remifentanil guided by bispectral index in comparison to intravenous anesthesia~     in elderly patients undergoing major noncardiac surgery. Methods: After approval of the local~     ethical committee was obtained, 204 patients (American Society of Anesthesiologists physical~     status I-III; age, > 55 yr) undergoing surgery (duration, > 1 h) were enrolled into this~     pospective randomized monocenter study. Patients received anesthesia 3 days after using a~     neuropsychological test battery.~   "
55434|NCT02841410|"~     This fMRI study evaluated the cognitive mechanisms and the cerebral substrate of decision~     making when evaluating the healthiness of food products with nutritional information~     displayed either with a Traffic Light system, a colored nutritional label, and a Guideline~     Daily Amount system, a numeric label.~   "
55435|NCT02841384|"~     Introduction: Patellofemoral pain syndrome (PFPS) is related to the previous sore knee,~     change functionality and postural control deficits. One of the possibilities for pain control~     and better positioning of the patella is the rigid bandage patellar widely used by clinicians~     and researchers.~      Objective: To evaluate the effect of rigid patellar bandage on postural control, pain and~     function in sedentary women with PFPS.~      Methods: The sample will be composed of 30 volunteers, sedentary, between 18 and 55 years;~     randomized group Bandage Functional Rigid (n = 15) and Banding Placebo (n = 15). All fill the~     Personal Data Sheet, Visual analog scale Pain Questionnaire Previous Knee Pain Scale; and~     will be submitted to analysis of postural control (static and dynamic) and carry out the test~     and sit up in pre conditions and post application of the bandage.~      Hypothesis: Expected to observe the effect of rigid patellar bandage in pain, function and~     postural control in sedentary women with PFPS.~   "
55448|NCT02841215|"~     Severe forms of scabies (crusted scabies and profuse scabies) require a specific treatment.~     Ivermectin is a recommended treatment in common forms of scabies and represents a promising~     treatment in crusted scabies in case reports. However, response to ivermectin remains~     variable among studies, and there is no consensus on the schemes to adopt (dosages and~     administrations). Ivermectin at 400 µg/kg has already been used, without showing toxicity (in~     head lice treatment in particular). Investigators propose to demonstrate that 400µg/kg~     ivermectin dosage will show better efficacy than a 200µg/kg in patients with severe forms of~     scabies (crusted and profuse).~   "
55449|NCT02841202|"~     The investigators aimed to evaluate the effect of oral contraceptive pills(OCP) on macula,~     retinal nerve fiber layer and choroid thickness by using Optical Coherence Tomography (OCT).~     The present clinical study is the first research reported in the literature which is~     investigating the posterior ocular segment changes in women using OCP by using OCT.~   "
55436|NCT02841371|"~     Chronic kidney disease (CKD) is a global public health problem. The prevalence of CKD in~     adults in China was 10.8%. Albuminuria measurement and estimating glomerular filtration rate~     (GFR) are the primary means of screening for CKD in epidemiological investigations. However,~     there are many important problems to be solved, whether albuminuria test or GFR evaluation.~     The investigators aim to detect thrice albumin-creatinine ratio (ACR) within three months,~     with simultaneous test of urinary protein-creatinine ratio (PCR), 24-hour urine protein~     excretion rate (PER) and 24-hour albumin albumin excretion rate (AER) to compare the effects~     of different times of screening for CKD and observe the daily physiological variation of ACR,~     PCR, AER and PER, derive ACR and PCR reference value on the basis of different genders, in~     order to facilitate the early diagnosis of CKD. Meanwhile, for more accurate assessment of~     GFR in Chinese populations, the investigators intend to validate beta-trace protein (BTP)~     based equation to evaluate GFR compared with 99mTc-diethylenetriamine pentaacetic acid (DTPA)~     renal clearance method. Then to develop GFR estimation equation based on the combination of~     serum creatinine, cystatin C, β2 -microglobulin and BTP applicable in China.~   "
55437|NCT02841358|"~     Niemann-Pick disease, Type C is a rare genetic disorder characterized by a failing in~     intracellular cholesterol transport, inducing an accumulation of sphingolipids in the brain.~      Neurological signs are at the forefront of the disease. There are also psychiatric signs of~     psychotic kind among 28 to 45 % of patients according to studies, and a thirty cases were~     published. These signs can be concomitant with neurological signs or precede them.~      Is is likely that psychotic disorders are the first signs of a Niemann-Pick disease not yet~     non encore diagnosed for some patients. Yet, no prevalence study for this disease in a~     psychiatric population of patients currently exists. In response to this problem this study~     proposes to search patients whose disease could be of organic origin or patients whose~     disease is suspected, based on clinical data. The diagnosis will be confirmed certified with~     a genetic and/or biochemical test.~   "
55438|NCT02841345|"~     In the case of psychotic disorders such as bipolar disorder or schizophrenia, attention~     dysfunction contribute, according to the theories of neuroscience, the development of mood~     disorders following disturbances in the interaction-care emotion. In this context, the~     general objective of this research project is to refine our understanding of the similarities~     and distinctions between bipolar and schizophrenic patients in the basic emotional~     information processing. Specifically, these are: 1) to better understand what level of basic~     emotional information processing both conditions differ or are comparable and in what sense~     and 2) estimate, in both pathologies, the specific influence of the nature of the task of~     processing emotional information. To answer these questions, the investigators have developed~     a protocol to specifically target different information processing channels playing on the~     nature of the spatial frequency content of emotional natural scenes. To estimate in both~     pathologies, the specific influence of the nature of the task on emotional processing, 3~     types of tasks are proposed: 1) a simple task perception and 2) -3) two tasks whose~     categorization one focused on the emotional feelings of the individual and the other on the~     tendency to action. Both tasks categorization should involve more specifically the~     ventromedial prefrontal cortex (CPFVM) and the dorsolateral prefrontal cortex (DLPFC)~     respectively. All patient data will be compared with data from healthy control participants.~   "
55439|NCT02841332|"~     The purpose of this study is to estimate the capacity of the multimodal imaging parameters~     measured at 15 days and 2 months of initiation of treatment with bevacizumab, to measure~     changes in clinical status (sensitivity to measure changes) in patients treated for recurrent~     glioblastoma.~   "
55440|NCT02841319|"~     The investigators have planned a research on the effects of virtual reality therapy and home~     exercise program on hand functions in children with hemiplegic cerebral palsy in Istanbul~     University Istanbul Faculty of Medicine in the Department of Physical Medicine and~     Rehabilitation. The eligible patients will be randomized into two groups. The patients in~     intervention group will participate in a computer based virtual reality exercise program for~     a period of 8 weeks supervised by the investigators. In addition, these patients will receive~     a home exercise program. The patients in the control group will receive only a home exercise~     program for 8 weeks. All patients will be evaluated before treatment, immediately after~     treatment, and 3 months after the end of the treatment.~   "
55441|NCT02841306|"~     20 patients presenting a rhegmatogenous retinal detachment with more than 4 days of duration~     will be prospectively included.~      A single dose of ursodeoxycholic acid will be administered orally before surgery at different~     time-points in 16 subjects. Standard surgery will be performed and ocular samples will be~     collected during the procedure. Ursodeoxycholic acid treatment will be continued in treated~     patients during 3 months after surgery.~      Ocular and serum samples from the 4 untreated patients will serve as negative controls for~     the determination of UDCA levels.~   "
55442|NCT02841293|"~     The originality of the GRECCAR project is to propose a holistic approach of the evaluation~     combining the paradigms of surgical efficacy, costs, quality of life and oncological~     adequacy, reflecting real life.~   "
55443|NCT02841280|"~     It is estimated that in the United States there are approximately 8 million individuals who~     have moderate to severe chronic kidney disease (CKD). Among them hypertension is common and~     is often poorly controlled due to an expanded volume state; diuretics are frequently~     prescribed. Loop diuretics are potent and effective in lowering blood pressure (BP) but their~     use is associated with acute kidney injury. Thiazide diuretics, on the other hand, are less~     potent, their use may be associated with less acute kidney injury, but as yet there are no~     firm data to support that thiazide diuretic therapy can improve BP among subjects with~     advanced CKD. The investigators found 13 studies on the use of thiazide diuretics in advanced~     CKD either alone or in combination with loop diuretics and concluded that thiazides may be~     useful. Thiazides cause a negative Na balance, increase Na excretion by 10-15% and weight~     loss by 1-2 kg in observational studies. Observational data show that thiazides lead to an~     improvement in seated clinic BP of about 10-15 mmHg systolic and 5-10 mmHg diastolic whereas~     randomized trials show about a 15 mmHg reduction in mean BP. Randomized trials had only~     between 7 and 23 subjects each; accordingly, larger studies are needed to evaluate their~     safety and efficacy in moderate to advanced CKD.~   "
55486|NCT02840708|"~     Objective: Evaluate Pharmacokinetics and determine the safety of GM-CSF single dose~     inhalation.~      Study Design: Pharmacokinetic open study~   "
55451|NCT02841176|"~     This study will be an open label pilot study to explore the utility of thermography in~     assessing response to Golimumab treatment in Psoriatic Arthritis (PsA). Ten patients~     fulfilling the Classification criteria for Psoriatic Arthritis (CASPAR) for Psoriatic~     Arthritis with active disease and eligible for anti-TNF therapy will be invited to~     participate in this study. They will be assessed at 4 time points during the study: prior to~     their first anti-TNF medication (screening and basal visits), and subsequently within 5 days~     after their 2nd and 4th doses of monthly Golimumab.~   "
55452|NCT02841163|"~     Measurement of herniated disc resorption and assessment of satisfaction regarding~     post-treatment state and integrative Korean medicine treatment through phone interview in 500~     patients with MRI follow-up results receiving treatment for lumbar and cervical disc~     herniation at Jaseng Hospital of Korean Medicine.~   "
55453|NCT02841150|"~     The purpose of this study is to demonstrate the bioequivalence (BE) of a new formulation of~     ibrutinib to the marketed Imbruvica formulation in healthy adults under fasted conditions.~   "
55454|NCT02841137|"~     This is a phase II study intended to determine the effect of progesterone 5, 10 and 20 mg~     tablets compared to progesterone 100 mg capsules on the endometrial thickness of~     post-menopausal women under hormone therapy with estradiol.~   "
55455|NCT02841124|"~     The decision to limit or withdraw specific therapies (DLWT) in patients with advanced cancer~     is a complex process that is always painful for patients, relatives and professionals. For~     more than 10 years, shared decision making has been more and more emphasized. However, few~     data in the literature rely on clinical research. In order to understand their difficulties~     and issues, this study explores the determinants and modalities of DLWT and analyses the~     feasibility of different methods for investigating this decision making process.~   "
55456|NCT02841111|"~     Kidney transplantation is the treatment of choice for ESRD. However, the life expectancy of~     kidney transplant patients is lower than that of the general population. Deaths recipients~     are due mainly to cardiovascular diseases related to a chronic inflammatory state. In~     addition, renal transplant patients frequently have anemia, identified as an independent~     cardiovascular risk factor that can be corrected by blood transfusion.~      But the relationship between transfusion and inflammatory condition are bidirectional. The~     patient's inflammatory condition will sound on the effectiveness of transfusion and~     transfusion could trigger an inflammatory condition. This has been reported with the said~     blood components aged, especially with packed red cells in patients hospitalized in~     intensive care after heavy heart surgery.The main objective of this study is to evaluate the~     impact of early transfusions on the evolution of renal transplantation (ie death, anti-HLA~     immunization, acute rejection, graft loss, delayed graft function, cardiovascular events )~     taking into account in the analysis: patient age at the time of transplantation, the number~     of incompatibility (s) (HLA class I and / or II) between the graft and the patient and sex of~     the recipient.~      This is a multicenter retrospective observational study (descriptive epidemiological~     study).The impact of early transfusions is determined retrospectively over a period of 6~     years from 01 January 2002 to 31 December 2008, in renal transplant patients of all centers~     of France met the criteria for inclusion. This cohort represents about 12 000-14 000 patients~   "
55457|NCT02841098|"~     The purpose of this study is to determine whether carotid surgery combined with optimal~     medical therapy improves long-term survival free of ipsilateral stroke in patients with~     asymptomatic carotid stenosis at higher-than-average risk of ipsilateral stroke when compared~     with optimal medical therapy alone.~   "
55458|NCT02841085|"~     Identify new genetic mutations predisposing to an increased risk of VTE by locating and / or~     identifying genes involved in subjects at high risk for thrombotic and in whom screening for~     detectable hereditary thrombophilia was negative.~   "
55459|NCT02841072|"~     The primary objective of this study is to document the rates of success and serious~     complications among women having outpatient medical abortions with 200 mg mifepristone + 800~     buccal misoprostol at 64-70 days of gestation.~   "
55460|NCT02841059|"~     In this prospective, comparative non-randomized multiple teaching hospitals study, the~     investigators try to determine the relationship of total hysterectomy and Taiwanese female~     pelvic floor and sexual function from the view of epidemiology and clinical survey. This is~     an important issue that related to female autonomy, health care resources and even national~     health policy. The study results will help to understand whether there is unnecessary part in~     the current hysterectomy procedures and its potential health hazard.~   "
55461|NCT02841046|"~     To evaluate the application of fluid-infusion therapy with the combination of stroke volume~     variation (SVV) and cardiac index (CI) as the primary judgment in non-severe patients~     underwent resection of gastrointestinal tumor. Fifty patients (ASA Ⅰ-Ⅱ, 26-55 years old,~     cardiac functional gradingⅠ) scheduled for gastrointestinal tumor surgery were divided into~     two groups randomly: group C with CI as the primary judgment and group S with the combination~     of SVV and CI as the primary judgment.~   "
55462|NCT02841033|"~     Participants with AL Amyloidosis will receive the drug daratumumab by IV infusion once weekly~     for two months, then every 2 weeks for four months, then once each month. Study treatment may~     continue until disease progression, unacceptable toxicity, or decision to withdraw from the~     trial. Disease evaluations will be performed every three months until disease progression.~   "
55463|NCT02841020|"~     The purpose of this study is to determine if biopsy for non-neoplastic renal disease for~     patients with a small renal mass results in greater postoperative renal function than the~     current standard of care (no additional biopsy).~   "
55464|NCT02841007|"~     The geko™ device is indicated for the prevention and treatment of oedema. The aim of this~     study is to show that recruiting, and performing study assessments in ankle fracture patients~     requiring surgery to fix their ankle attending the James Cook Hospital is feasible, and to~     obtain data to support the powering of a larger study to demonstrate the effectiveness of the~     geko™ device at reducing length of stay for this population of patients. This study will also~     allow us to assess the acceptability, tolerability and compliance of treatment with the geko~     device.~   "
55539|NCT02840019|"~     The goal of Advanced Fetal Imaging - Phase II is to advance fetal MRI imaging by designing~     MRI coils specifically for pregnant women and testing recently developed MRI image~     acquisition techniques. The investigators aim to more reliably obtain higher quality fetal~     MRI images when compared to current clinical fetal MRI.~   "
55465|NCT02840994|"~     The objective of the proposed clinical trial is to investigate the safety and tolerability of~     CV301 in combination with Anti-PD1-Therapy compared to Anti-PD1-Therapy alone in subjects~     with non-small cell lung cancer (NSCLC).~      The clinical trial is designed to evaluate the possible enhanced antitumor activity of CV301~     with Anti-PD1-Therapy compared to Anti-PD1-Therapy alone. The rationale for combining CV301~     with Anti-PD1-Therapy is based on the hypothesis that CV301 can induce specific immune~     response in the tumor, and that in combination, Anti-PD1-Therapy may augment the T~     cell-mediated immune response generated by CV301 by blocking the inhibitory signal of the~     PD-1.~      The trial will include a Phase 1 portion, a Phase 1b portion with 2 cohorts and a Phase 2~     portion.~      The Phase 1 portion is a dose escalation part to assess the safety and tolerability of CV301~     alone, prior to moving into the combination with Anti-PD1-Therapy (the Phase 1b component).~      The following Phase 1b portion of the trial aims to test the safety and tolerability of the~     combination treatment using a two cohort approach with cohort 1 receiving CV301 plus~     Nivolumab and cohort 2 receiving CV301 plus Pembrolizumab, before expanding the number of~     patients to be treated in the randomized Phase 2 portion of the trial.~      The objective of the Phase 2 portion is to assess the safety and preliminary efficacy of~     CV301 in combination with Pembrolizumab compared to Pembrolizumab alone in subjects with~     NSCLC.~   "
55466|NCT02840981|"~     The Mediterranean diet (MD), a healthy dietary pattern based on some common dietary~     characteristics in Mediterranean countries, is associated with high antioxidant capacity~     linked to the low saturated fat intake that might contribute to reduce free fatty acid (FFA)~     availability and oxidation in mitochondria, thus reducing the production of the reactive~     oxygen species (ROS) superoxide, and promoting cellular health. To assess the adherence to~     the MD, a simple 14-item questionnaire had been tested in different settings by the PREDIMED~     (PREvención con DIeta MEDiterránea) multicenter, randomized, primary prevention trial. On the~     other hand, to allow a more an accurate measurement of the actual macro and micronutrient~     intakes, including dietary anti-oxidant micronutrients, the 7-day food records is considered~     as the gold standard of self-administered food frequency questionnaires.~      Circulating levels of Sirtuin 4 (Sirt4), part of a complex of proteins that control diverse~     biological processes, including lipid metabolism, are low in obese patients, as a possible~     attempt to decrease fat oxidative capacity and mitochondrial ROS production, however~     promoting ectopic liver fat storage.~      The phase angle (PA), a measure determined by bioelectrical impedance analysis (BIA), and the~     visceral adiposity index (VAI), a gender-specific mathematical index based on simple~     anthropometric and metabolic parameters, represent well-validated, reliable and widely used~     markers of cellular health and ectopic adipose distribution and function, respectively. The~     fatty liver index (FLI) is a surrogate measure for fatty liver recently proposed as an~     independent predictor for diabetes mellitus.~      Aim of the present study was to investigate in adult obese individuals the levels of Sirt4~     according to the adherence to the MD evaluated by PREDIMED questionnaire, focusing on the~     possible association with single dietary components evaluated by 7-day food records, and to~     evaluate the association between circulating levels of Sirt4 and PA, as marker of cellular~     health, VAI, as index of adipocyte dysfunction, and FLI, as a predictor of fatty liver.~   "
55467|NCT02840968|"~     In this cross-sectional observational study the investigators evaluated the association~     between the adherence to the MD and PhA in a sample of adult population, stratified according~     to categories of sex, age, and BMI.~   "
55468|NCT02840955|"~     Colonization with Staphylococcus aureus is related to inflammation in atopic dermatitis.~     Gladskin is a product for topical use containing the proprietary enzyme Staphefekt SA.100,~     which has the ability to specifically lyse the cell wall of S. aureus. The investigators~     hypothesize that Staphefekt decreases S. aureus colonization of the skin and consequently~     decreases symptoms of atopic dermatitis.The goal of this study is to determine the effect of~     Staphefekt on the use of topical corticosteroids in patients with atopic dermatitis.~     Secondary goals are to retrieve information about the effect on clinical symptoms, quality of~     life, growth characteristics of Staphylococcus aureus and the further microbiome.~   "
55469|NCT02840942|"~     Peripheral intravenous catheters (IVs) are utilized in the majority of hospitalized children.~     The placement of IVs requires significant staff time, contributes to health care costs, and~     causes pain and distress in the patients receiving them. Techniques currently used at~     Children's Hospital Los Angeles (CHLA) to reduce children's anxiety and increase success of~     IV placement center depends on members of the Child Life Department distracting patients~     during insertion. Recent literature has suggested that humanoid robots can be a powerful form~     of distraction and lead to decreased pain during painful procedures in children. Work done by~     the University of Southern California (USC) Interaction Lab has shown that socially assistive~     robots can use techniques more complex than pure distraction to lead to a human-robot~     interaction that is perceived as more positive by the human. The investigators propose a~     project pairing children receiving an IV with either a (1) Child Life staff member only (2)~     pure distraction robot + Child Life or (3) an robot teaching coping skills + Child Life with~     a goal of reduced pain. Pain will be measured by participant self-report, family member~     perceived pain, parasympathetic activation, and pain behaviors as measured by video.~   "
55470|NCT02840929|"~     OBJECTIVES: Up to 15% of patients with peptic ulcer bleeding will develop rebleeding, mainly~     in those with ulcers of higher-risk stigmata (i.e. Forrest class Ia to IIb). Randomized~     trials show that second-look endoscopy is effective in reducing rebleeding rate. However,~     whether to withhold aspirin or other anti-platelet agents (for the treatment of established~     cardiovascular or cerebrovascular diseases) remains controversial. Studies have shown that~     although continuation of anti-platelet agents reduces mortality rate due to reduced~     cardiovascular and cerebrovascular events, there is a marginal increase in rebleeding risk.~      HYPOTHESIS: We hypothesize that continuation of aspirin or other anti-platelet agents coupled~     with second-look endoscopy could reduce the rebleeding rate without increasing the risk of~     thromboembolic events in high-risk patients.~   "
55471|NCT02840916|"~     Objective: To determine the therapeutic effect of acupuncture on postpartum weight retention.~      Methods: 66 subjects after delivery with postpartum weight retention will be randomly divided~     into laser acupuncture and control group. A single-blind clinical trial will be conducted and~     the subjects will be treated with verum or sham laser acupuncture 5 sessions per week. After~     about 3 weeks of treatment, the differences of the subjects' body weight, body mass index,~     and waist circumference will be analyzed with ANOVA between laser acupuncture and control~     group.~   "
55472|NCT02840903|"~     The objective of this study is to evaluate the image quality for different iodine delivery~     rates at different low voltage scanning protocols (80 or 100 kV ) under the modern advanced~     Multi-Detector Computed Tomography (MDCT) considering the body weight of patients.~   "
57268|NCT02817399|"~     The purpose of this study is to examine the short term effect of functional electrical~     stimulation treatment versus neuro-muscular electrical stimulation on gait quality for~     patient after anterior cruciate ligament reconstruction.~   "
55473|NCT02840890|"~     Adjuvant chemotherapy with the protocol 3 cure of 5-FU + Epirubicine + Cyclophosphamide~     (FEC100) and 3 cure of Taxotere is a standard treatment in the management of patients with~     breast cancer and in adjuvant situation.~      The efficacy of 3 FEC100 and 3 Taxotere protocol in adjuvant situation for women treated for~     breast cancer is associated with several invalidating side effects for the quality of life of~     patients. 92% of women treated will present gastrointestinal toxicities of any grade. 11%~     will present nausea and vomiting of grade 3-4. Current treatments to prevent these~     gastrointestinal toxicities include Emend from Day 1 to Day 3 in association with setrons at~     Day 1 and corticosteroids from Day 1 to Day 3. Despite the marked improvement in~     gastrointestinal toxicities with preventive treatments, 83% of patients would use~     alternatives medicine: homeopathy, herbal medicine, acupuncture, hypnotherapy and / or~     osteopathy.~      Osteopathy is a method of care and unconventional therapeutic approach. In France, the~     professional title of osteopath is recognized. It aims to prevent and treat functional~     disorders, especially those related to adverse effects of treatment. In oncology, this~     discipline may have additional support for the patient by limiting the mechanical and~     physical constraints of sensitive areas to the toxicity of the treatment. In the case of~     gastrointestinal toxicities of myofascial and musculoskeletal techniques are used in~     abdominal areas to relieve symptoms. The investigators hypothesis is that osteopathy could~     have an interest in the management of gastrointestinal toxicities related to chemotherapy in~     women with breast cancer and in adjuvant treatment situation.~   "
55474|NCT02840877|"~     After HIV/AIDS, tuberculosis (TB) remains the second leading cause of death due to an~     infectious disease globally. Retrospective studies from many countries, including the United~     States and South Africa, have consistently reported that in addition to having a higher~     burden of TB disease, patients with problem alcohol use have worse TB treatment outcomes.~     This prospective study will attempt to clarify both behavioral and biologic causal mechanisms~     underlying the deleterious effects of problem alcohol use on TB treatment response.~   "
55475|NCT02840864|"~     Aim of the study is to test whether surgical removal of a tumor under sonographic control as~     compared to conventional method reduces the rate of resections and local relapse~   "
55476|NCT02840851|"~     Baseline cerebral blood flow through the middle cerebral artery (MCA) and cerebral~     vasodilator response of the MCA to inhaled carbon dioxide (CO2) will be measured in young~     women, young men, older women, and older men using Magnetic Resonance (MR) imaging and~     transcranial Doppler ultrasound (TCD). Data collection techniques will be compared.~   "
55477|NCT02840825|"~     Human cytomegalovirus (HCMV) is the leading cause of neonatal viral infection and can have a~     significant impact on the neurosensory development of newborns and especially preterm~     infants. HCMV infection may result from maternal-fetal transmission during pregnancy or~     postnatal transmission. While congenital HCMV infection affects about 2-5% of very preterm~     infants, the risk of postnatal infection, particularly through breast milk, is much higher in~     this population (prevalence of about 20%). Many learned societies wonder about the interest~     to inactivate HCMV (by freezing or pasteurization) in breast milk in order to reduce or~     eliminate contamination of these children. However, freezing is relatively inefficient to~     reduce contamination and pasteurization drastically alters the nutritional quality of the~     milk. Therefore, a systematic preventive treatment of breast milk for very preterm infants is~     not currently recommended. An alternative approach could consist in detecting HCMV in breast~     milk to target at-risk situations. This detection can be performed by PCR but its cost and~     the time required to obtain the result prohibits its use for a mass detection. Currently,~     viral status of breast milk is not explored in practice and, depending on the health centers,~     breastfeeding is continued as such or milk is systematically inactivated.The main objective~     of VIRUMILK is to study the feasibility of the CMV detection in breast milk from lactating~     mothers with a biochip.The ultimate goal is to prevent postnatal HCMV infection of preterm~     newborns less than 33 weeks.~   "
55478|NCT02840812|"~     This is a single center, open-label, non-randomized, 1:1 parallel control and single dose~     administration study design. Healthy subjects will be matched to severe renal function~     impaired (eGFR≤30mL/min/1.73m2，CKD-EPI estimated) subjects in age, gender and weight as~     parallel control, which matches healthy with normal renal function according to the of~     subjects with impaired renal function as, after enrollment of subjects with severe impaired~     renal function (eGFR≤30mL/min/1.73m2，CKD-EPI estimated). Renal function impaired group and~     control group both receive orally single-dose of nemonoxacin malate capsule (0.5g). Collect~     the blood and urine samples before and after the administration to perform pharmacokinetic~     analysis and safety observation.~   "
55479|NCT02840799|"~     This trial seeks to assess if potassium nitrate (KNO3) therapy improves exercise capacity and~     oxygen uptake in heart failure patients with preserved ejection fraction (HFpEF).~   "
55480|NCT02840786|"~     This is a randomized study comparing stent and plaque excision systems in treatment of~     Arteriosclerosis occlusive disease of lower extremity (superficial femoral or popliteal~     artery)~   "
55481|NCT02840773|"~     The aim of the present study was to determine the levels of sRANKL and OPG as well as their~     relative ratio in PICF surrounding the two different types of implant-abutment connections on~     short implants after a 12-month monitoring period. Additionally, their association with~     clinical findings and microbiological markers in plaque samples were assessed in the present~     study.~   "
55482|NCT02840760|"~     The purpose of this study is to explore the therapeutic effect and mechanism of transcranial~     magnetic stimulation (rTMS) in the treatment of the tardive dyskinesia.~   "
55483|NCT02840747|"~     This document is a protocol for a non-interventional human research study in which the~     investigator hopes to better understand the changes that take place in T cells in Cutaneous~     T-cell lymphoma (CTCL). The purpose of this study is to establish a protocol for the~     collection and storage of tissue samples from patients with CTCL for future research studies.~     Collection and storage of tissue samples from control patients will also be carried out.~   "
55484|NCT02840734|"~     This study investigated the immediate effects of Kinesio taping on muscular power, strength,~     endurance, and lower limb fatigue when taping is applied to rectus femoris and around the~     patella of obese adults based on Kinesio taping techniques.~   "
55485|NCT02840721|"~     The purpose of this study is to evaluate the safety, tolerability, and efficacy of~     PF-06480605 in subjects with moderate to severe ulcerative colitis.~   "
55487|NCT02840695|"~     Ankylosing spondylitis (AS) is a rheumatoid disease affecting all segments of the axial~     skeleton, leading to the complete fusion of all spinal segments - the bamboo-spine. During~     the last decade biological disease modifying anti-rheumatic drugs (bDMARD) have been~     successfully introduced to reduce the disease activity. It is unclear whether bDMARD~     treatment had an effect on spinal fracture risk related to AS. This national registry study~     will investigate the effect of bDMARD treatment on spinal fracture risk in a national cohort~     of patients with AS.~   "
55488|NCT02840682|"~     The primary objective of this study is to describe mortality of newborns who received basic,~     advanced or no neonatal resuscitation immediately after birth at Shoklo Malaria Research~     Unit.~   "
55489|NCT02840669|"~     Friedreich's ataxia (FA) is an autosomal recessive disease with an incidence of 1/50,000 in~     the Caucasian population. The main manifestations of FA are progressive sensory and~     cerebellar ataxia and cardiomyopathy (CM). It is the most common form of inherited ataxia. A~     severe CM affects ~60% of FA patients, mostly young adults, and leads to cardiac failure then~     death. Currently, no therapy can change the course of this severe cardiomyopathy.~      This study is designed to characterize the cardiac manifestations of FA using cardiac~     magnetic resonance (CMR), echocardiography, serum cardiac biomarkers and evaluation of~     fatigue severity, in the context of the neurological disease.~   "
55490|NCT02840656|"~     In this prospective observational study we aim to determine the prevalence of oropharyngeal~     and rectal Gram-negative bacilli colonization in healthy subjects, and their susceptibility~     to chlorehexidine. We plan to recruit 100 healthy volunteers secondary endpoints are to~     determine the phylogentic characteristics of E. coli isolates; to compare the phylogentic~     characteristics of oropharyngeal and rectal of predominant GNB colonization.~   "
55491|NCT02840643|"~     To examine efficacy of combined unimanual and bimanual intensive therapy in children with~     unilateral brain injury. A key question in hemiplegia therapy is whether the affected hand~     should be trained alone or in tandem with the other hand. In constraint-induced movement~     therapy (CIMT), a participant's less-affected upper extremity is restricted with a sling,~     cast, or mitt, while the participant actively uses the affected arm and hand in skill-based~     therapeutic activities. Bimanual therapy, in contrast, engages both hands in therapeutic~     movement. Since constraint and bimanual therapy target different aspects of hand use, they~     could have synergistic effects on hand function when given in combination.~   "
55492|NCT02840630|"~     The investigators will recruit non-diabetic volunteers (n=30) and diabetic volunteers~     controlled by diet and lifestyle (n=300). The non-diabetic volunteers will be in the~     non-diabetic group while the diabetic volunteers will be randomised to a diabetic control~     intervention group or a diabetic fish intervention group. Baseline data will be collected~     from all three groups but only diabetic control intervention group and diabetic fish~     intervention group will go through the 16-week study. This will allow the investigators to~     compare the metabolic health across South Asian population in people with and without~     diabetes.~      The recommended intake of EPA and DHA daily is ~450 mg per day for cardiovascular health, or~     approximately 3 g per week. Over the course of 16 weeks, subjects in the diabetic control~     intervention group will continue with their habitual diet, while subjects in the diabetic~     fish intervention group will receive two 125 g portion of tinned mackerel (containing 7.8 g~     n-3 LCPUFA26) every week, to replace a portion of red meat or poultry. Previous n-3 LCPUFA~     intervention study among South Asian people in the United Kingdom was able to reverse lipid~     abnormalities with supplementation of 2.5 g of EPA and DHA per day for 12 weeks. However, the~     same study also shows that their daily consumption of EPA and DHA is only 68±99 and 112±171~     mg respectively. Therefore, only 1.1 g n-3 LCPUFA per day is given in this study to increase~     compliance.~      Recipe recommendations using mackerel will be provided. Non-diabetic volunteers will be~     recruited only to obtain baseline data in order to compare their metabolic profile with that~     of the diabetic volunteers. This will allow us to investigate the link between omega 3 status~     and glycaemic control in a South Asian population.~      Fish is chosen as an intervention as opposed to EPA and DHA supplements in order to capture~     the benefits of eating fish as an important source of not only n-3 LCPUFA, but also other key~     nutrients such as vitamin D, selenium and iodine.~   "
55493|NCT02840617|"~     This study aims to evaluate the feasibility of indocyanine green (ICG)-based fluorescence~     imaging in the detection of prostate tumors and metastatic lymph nodes. By correlating the~     ICG fluorescence patterns with pathologically confirmed tumor and nodal status, it would be~     possible to use fluorescence navigation system in helping prostate biopsy and lymph node~     dissection in the future.~   "
55494|NCT02840604|"~     The management of cancers and their therapeutic guidance was until shortly mostly based on~     histopathological considerations of the tumor. the development of targeted therapies is a~     turning point and keeps increase. These molecules target a specific molecular defect in the~     tumor making it more effective and more specific treatment. But these treatments are only~     effective if the tumor has a specific molecular abnormality that is characterized and known.~      These therapeutic progresses have been made possible through the decoding of the human genome~     and the molecular defects occurring during the carcinogenesis process. Now, dozens of~     therapies targeting a specific molecular abnormality are available in the therapeutic arsenal~     and dozens more are under development in clinical trials Phase 1 to 3.~      In recent years, the democratization of next generation sequencing has opened a new era in~     cancer research but also for molecular diagnostics. Indeed, the enormous sequencing~     capabilities offered by high-throughput sequencing technologies allow analysis in a limited~     time the entire coding sequence of the genome (exome), or even the entire genome of a tumor~     (whole genome sequencing). Thus, the evolution and the development of broadband and~     associated bioinformatics tools for genomics techniques now make it possible to establish the~     genetic profile of a tumor. Targeted diagnosis of molecular abnormalities and allows to~     propose and specifically targeted direct therapeutic identified genetic alterations and~     supposedly responsible for tumor development. An analysis of tumor exome by next-generation~     sequencing (NGS) and provides information on genetic modifications of these tumors.~      This study did not aim to evaluate a therapeutic strategy or treatment. The objective of this~     study is to evaluate the clinical benefit of an analysis of exome performed in current~     practice at the Centre Georges-François Leclerc from Dijon. The analysis will be performed by~     quantifying the number of patients undergoing therapeutic proposal based on the results of~     the analysis of the profile of the tumor.~   "
55495|NCT02840591|"~     Primary aim of this study is to assess the feasibility of conducting clinical research for~     delirium (confusion due to medical problems) at Clements University Hospital in Dallas,~     Texas. A secondary aim is to assess whether an FDA-approved sleeping aid called Ramelteon or~     an over-the-counter supplement called Citicoline are safe and beneficial in delirium.~   "
55496|NCT02840578|"~     Objectives: To examine whether NK cell activity associates with two confirmed risk factors:~     (1) presence of indeterminate lung nodule(s) and (2) smoking exposure after controlling for~     potential confounders, including age, gender, body mass index (BMI), personal history of any~     cancer, and family history of cancer. This project is aimed at measuring NK cell activity,~     which may eventually help in reducing false positive rates of LDCT screening, improve early~     detection of lung cancer, and assist in risk assessment in patients with lung cancer. The~     investigators hypothesize that measurement of NK cell activity may be a useful tool for~     assessing changes in immunosurveillance in patients with conditions or diseases where NK cell~     activity has been shown to be reduced, such as lung cancer~   "
55497|NCT02840565|"~     The purpose of this study is to assess the tolerability of BIA 5-453 after six multiple~     rising dose regimens of BIA 5-453.~   "
57269|NCT02817386|"~     The purpose of this study is to investigate the possible relationship of microRNA and~     postoperative delirium.~   "
55498|NCT02840552|"~     The objectives of this study are to confirm the safety and efficacy of FCH-PET/CT and to~     establish our ability to reproduce results from the literature using FCH-PET/CT as a~     diagnostic and decision making tool in the management in two predefined groups of prostate~     cancer patients, specifically, biochemical recurrence and high risk staging. The primary~     endpoints of the study are the incidence of adverse events (AE) in the study population up to~     24 hours following the scan, and the sensitivity and specificity of FCH-PET/CT vs CT on a~     per-patient and per-lesion basis.~   "
55499|NCT02840539|"~     The purpose of this study is to determine whether bortezomib, cytarabine, and dexamethasone~     are effective in the treatment of relapsed or refractory mantle cell lymphoma after 1 to 3~     lines of previous treatment.~   "
55500|NCT02840526|"~     Objective: The objective of the study was to assess the usefulness of ThPVB in postoperative~     pain management after open renal resection surgery.~      Design, setting, participants: It was a prospective, randomised, open label study held in a~     university hospital between 08.2013-12.2014. 58 Patients enrolled in the study were scheduled~     for elective open renal surgery (open nephrectomy or open nephron-sparing surgery) and~     randomised into two groups - group PVB (n=27) and group GEN (n=31).~      Interventions: PVB group received preoperative ThPVB with 0,5% bupivacaine followed by~     general anaesthesia. GEN group received standard general anaesthesia. Both groups were~     treated postoperatively with oxycodone IV PCA (patient controlled analgesia) combined with~     non-opioid analgesics as rescue drugs. The investigators recorded pain severity in VAS,~     oxycodone requirement in time points, total oxycodone requirement, and sedation levels~     throughout the first 48h. The investigators measured opioid related adverse events 24 and 48~     h postoperatively and patients satisfaction 48h postoperatively.~   "
55501|NCT02840513|"~     This randomized controlled trial is going to evaluate whether an intervention consisting of a~     smartphone application to assist smokers living with HIV to quit in combination with CO~     self-monitoring compared to stop smoking counselling by physicians during usual care results~     in higher self-reported and biochemically verified smoking cessation rates at 6 months.~   "
55502|NCT02840500|"~     Patients treated in Palliative Care Units are potentially fragile patients, especially in our~     case, which are cancer patients. The management of these patients is usually done from~     experience, because these patients rarely meet criteria for clinical trials, as their~     inclusion could affect results obtained in the trial.~      There is insufficient clinical information on the quality of life of cancer patients with~     breakthrough pain treated in palliative care units according to routine clinical practice.~     For this reason we consider it is appropriate to prospectively evaluate the quality of life~     of cancer patients with cancer breakthrough pain treated in palliative care units as well as~     the characteristics of these patients.~      This post-authorization observational study will assess the quality of life of patients with~     breakthrough cancer pain treated in Palliative Care Units in Spanish hospitals.~   "
55503|NCT02840487|"~     Background:~      The Zika virus is passed to humans by infected mosquitos. It usually causes fever, rash,~     joint pain, and red eyes. Recently, some cases of microcephaly (abnormally small head) were~     reported in babies born to mothers infected with the Zika virus. Rare cases of a severe nerve~     weakness called Guillain-Barr(SqrRoot)(Copyright) syndrome were reported in some people with~     Zika virus infection. There is currently no cure for or vaccine against the infection.~     VRC-ZKADNA085-00-VP is a new vaccine that instructs the body to make a small amount of Zika~     virus protein. The body may use this to build an immune response.~      Objective:~      To see if VRC-ZKADNA085-00-VP is safe and causes any side effects.~      Eligibility:~      Healthy people ages 18 35~      Design:~      Participants will be screened through a separate protocol with:~        -  Medical history~        -  Physical exam~        -  Lab and urine tests~      Participants will be randomly assigned to 1 of 4 study groups. They will have about 18 clinic~     visits over 2 years. Most will occur in the first year, with long-term follow-up visits at~     months 18 and 24. Visits include a physical exam and blood and urine tests.~      Participants will have vaccine injections. A high-pressure device pushes the vaccine through~     the skin and into the muscle of the upper arm. They will have 2-3 injections depending on~     their group.~      Vaccine visits last 4-6 hours. Others last 1-2 hours.~      Participants will keep a diary for 7 days after each injection. They will record their~     temperature and measure any skin changes at the injection site each day.~      Participants might have extra visits and blood tests if they have health changes.~   "
55504|NCT02840474|"~     Background:~      The human body uses antibodies as one way to help fight infection. VRC01LS is an antibody~     directed against the HIV virus. Researchers want to see if it is safe and well tolerated.~     They will study the amount of VRC01LS in the body and how it changes over time. They will~     check to see if people who get VRC01LS develop an immune response to it.~      Objective:~      To see if VRC01LS is safe and well tolerated.~      Eligibility:~      Adults ages 18 70 who are HIV infected but otherwise healthy. Females who are able to get~     pregnant must be willing to use birth control during the study.~      Design:~      Participants will be screened in another protocol.~      Participants will get the study drug one time, by IV infusion. A needle will guide a thin~     tube into a vein. The study drug mixed with salt water will be dripped into the vein over~     about 30 minutes.~      Participants will be monitored for 30 minutes after the infusion.~      Blood samples will be taken at the following times:~      Once before the infusion~      5 times in the 4 hours after the infusion~      1 time 24 hours after infusion. Some participants may have 3 optional blood draws in the time~     period between 4 and 24 hours.~      For 3 days after the infusion, participants will write their temperature and symptoms in a~     diary.~      There will be a total of 23 study visits over 48 weeks. Ten visits will be in the first 4~     weeks. At all visits, participants will answer health questions and give blood samples.~   "
55505|NCT02840461|"~     A randomized, double-blind, placebo-controlled, parallel-design, multiple-site clinical study~     to evaluate the therapeutic equivalence and safety of ivermectin cream 1% (Actavis~     Laboratories UT, Inc.) to SoolantraTM (ivermectin) cream 1% (Galderma) in the treatment of~     moderate to severe papulopustular rosacea.~   "
55733|NCT02837497|"~     Pediatric cardiac arrest affects thousands of hospitalized children each year. High quality~     cardiopulmonary resuscitation (CPR) saves lives, but is difficult to achieve. The objective~     of this study is to determine if a novel patient-centric resuscitation care improvement~     bundle consisting of bedside CPR training and multidisciplinary reviews of each cardiac~     arrest improves CPR quality and survival outcomes in a multi-center trial.~   "
55506|NCT02840448|"~     Background:~      People with Williams Syndrome (WS) and supravalvular aortic stenosis (SVAS) have less~     elasticity in their blood vessels. This is called blood vessel stiffness. Blood vessels may~     have focal narrowings called stenoses or may just be globally more narrow.~      Objectives:~      Researchers want to see how blood vessel differences in people with Williams Syndrome and~     supravalvular aortic stenosis affect organs in the body including the heart, gut, kidneys,~     and brain.~      Eligibility:~      People ages 3-85 who have WS or SVAS~      Healthy volunteers ages 3-85~      Design:~        -  Participants will have yearly visits for up to 10 years. All participants will be~          offered the same tests.~        -  Participants will give consent for the study team to review their medical records. If~          the participant is a child or an adult with WS, a parent or guardian will give the~          consent.~        -  Participants will visit the NIH where they will have a physical exam and medical~          history. Based on their health history, participants will undergo a series of imaging~          tests and measures of blood vessel function over the course of 2-4 days. Tests of~          cognitive abilites will also be performed. Blood will be drawn and an IV may be placed~          for specific tests.~   "
55507|NCT02840435|"~     This study is designed to test the effectiveness of the smoking cessation intervention Sit~     to Quit through a randomized-control trial. This study will compare abstinence outcomes in~     the Sit to Quit study group to a control group using the North Carolina State Tobacco Quit~     Line.~   "
55508|NCT02840422|"~     The reduction of functional limits and disablilities induced by knee osteoarthritis as well~     as improvement of patients quality of life is a public health need registered amongst the~     priorities established by the French law of August 9th 2004 relative to Public Health policy.~     However, the response to this need is not limited to treatment with health products.~      This clinical trial in real life on ARTHRUM H 2% device aims to analyse patients quality of~     life treated by intraarticular injections, eventually for several years, by difference of~     usual clinical trials.~      This open, prospective, multicentric study aims to analyse, in patient care, the impact of~     three intraarticular injections of ARTHRUM H 2% on quality of life over a period of 6 months~     (D180) in the symptomatic treatment of knee osteoarthritis.~   "
55509|NCT02840409|"~     This is an open-label, randomized, multi-center, comparator Phase II trial looking at the~     addition of Bevacizumab to Vinblastine in chemotherapy naïve pediatric patients with~     progressive Low Grade Glioma aged 6 months to less than18 years of age at the time of~     initiation of therapy. Participants will be randomized to Arm A or Arm B. Arm A includes 68~     weeks of single agent Vinblastine administered once weekly IV. Arm B includes 68 weeks of~     Vinblastine administered weekly IV with the addition of 12 doses of Bevacizumab administered~     every two weeks IV for the initial 24 weeks. Randomization will take place at the time of~     registration taking into account NF1 and BRAF-KIAA1549-fusion status.~   "
55510|NCT02840396|"~     The purpose of this study is to investigate the effects of repetitive transcranial magnetic~     stimulation (rTMS) over the dorsolateral prefrontal cortex (DLPFC) on language production.~   "
55511|NCT02840383|"~     Assess the effects of a school-based multi-component intervention on school connectedness,~     school engagement, and developmental assets through a group randomized, participatory trial.~   "
55512|NCT02840370|"~     The purpose of this study is to investigate whether transcranial direct current stimulation~     (tDCS) of the prefrontal cortex (PFC) influences lexical access and language production. The~     experimental paradigm will assess the impact of prefrontal stimulation by tDCS versus sham~     tDCS (S-tDCS) over the PFC of patients with chronic post-stroke aphasia during three language~     production tasks and a nonverbal executive functions task.~   "
55513|NCT02840357|"~     The main purpose of this study is to determine the effect of consumption of purple wheat~     anthocyanin-rich products for eight weeks by human participants with an elevated level of~     chronic inflammation, on oxidative stress and inflammatory responses as measured by select~     plasma biomarkers.~   "
55514|NCT02840344|"~     This study aims to improve relationship, psychological, and physical adjustment among young~     breast cancer survivors (YBCS; diagnosed at age 45 or younger) and their committed/life~     partners. A mindfulness-based stress reduction (MBSR) intervention has been designed to meet~     the specific needs for young breast cancer survivors and their partners. The intervention~     will be administered in your home by using recorded videos of a trained MBSR instructor.~     Before, during, and after the 8-week intervention, participants will be asked to complete~     surveys.~   "
55515|NCT02840331|"~     The study would examine by hypericin-supported Fluoreszenzlaparoskopy in terms of tumor size,~     number and location of the combination of photodynamic diagnosis (PDD) and therapy (PDT) with~     regard to the detection of peritoneal metastases of locally advanced gastric cancer at 50~     adult patients.~   "
55516|NCT02840318|"~     The investigators developed the theory-driven 'Compassion Intervention', an integrated,~     interdisciplinary approach to address existing gaps in end-of-life care for people with~     advanced dementia. The Intervention consists of two core components: facilitation of an~     integrated, multi-disciplinary approach to assessment, treatment and care; and education,~     training and support for formal and informal carers. The intervention is implemented by an~     Interdisciplinary Care Leader. The primary aim is to understand how the Intervention operates~     in two care homes (with nursing support) in two different health and social care economies;~     one in the Camden Commissioning Group and one in the Barnet Commissioning Group, both in~     London, UK. The secondary aim is to collect preliminary outcome data and estimate the cost of~     employing an Interdisciplinary Care Leader to inform further evaluative studies. The final~     aim is to check that the Intervention causes no harm to residents and their family carers.~   "
55527|NCT02840175|"~     As biologic treatments are expensive and associated with some concerns regarding long-term~     safety, investigator hypothesize that early tapering and then withdrawal of biological agent,~     in an homogenous group of children with juvenile idiopathic arthritis achieving inactive~     disease, is safe and not inferior to the maintenance of stable treatment intensity over 24~     weeks. In addition, investigator also hypothesize that an earlier tapering of treatment is~     associated with a better quality-of-life and a general cost saving effect. MRP8/14 will be~     studied as a potential biomarker for the risk of relapse. A study for biologic agent,~     anti-biologic agent antibodies and a pharmacogenomic approach will complete the research, as~     pharmacokinetic study during withdrawal of biologic treatment are rare in children.~   "
55517|NCT02840305|"~     Using the available data from psychophysics, cellular electrophysiology and functionnal~     neuroanatomy of visual pathway, current models of visual recognition suppose that the~     perception of scenes start with a parallel extraction of differents elementary visual~     characteristics to different spatial frequencies according to a default processing principle~     named : 'coarse-to-fine'.~      According to this principle, the visual scene's analysis would be decomposed in two steps.~     Fisrt, the fast analysis of the global information borne by low frequency of the scene will~     provide an overview of the scene's structure and would enable a first perceptive~     categorisation which would be then refined, approved or denied by the latest analysis of the~     most local, detailed and precise information, carried by the very high spatial frequency of~     the scene.~      The research carried out since several years is preparing a biologically plausible model and~     to find brain bases by different imaging techniques among healthy subjects but also patients~     with a brain lesion and patients with a peripheral lesion.~      The main goal of this Magnetic Resonance Imaging study is to find brain bases of natural~     scenes's visual perception of the natural scenes.~      Three studies in Magnetic Resonance Imaging will be conducted, during which subjects will~     have to categorize pictures of natural scenes filtered in spatial frequencies. The outcome of~     this study will allow to refine models of visual recognition, most of them based on analysis~     of spatial frequencies.~   "
55518|NCT02840292|"~     The study entitled 'Effect of maternal hemoglobin on neurobehavioral development of late~     preterm neonates' was done with an objective to determine whether low maternal hemoglobin~     (<11gm/dl), in late preterm neonates(>34weeks but less than 37weeks gestational age)~     correlates with poor neurobehavioral outcome using the Neurobehavioral Assessment of Preterm~     Infants(NAPI) tool, thereby allowing for earlier rehabilitative intervention to be undertaken~     to improve their long term outcomes and to generate useful data on a previously well~     recognised but under researched entity.~   "
55519|NCT02840279|"~     This is a randomized, double-blind (Investigator and subject-blinded) placebo-controlled,~     multiple, ascending-dose study to evaluate the safety, tolerability, and pharmacokinetic~     profile of BPN14770 in healthy young and elderly male and female subjects and to provide a~     preliminary assessment of the cognitive effects of BPN14770 in healthy elderly subjects.~   "
55520|NCT02840266|"~     The purpose of study is to determine the diagnostic value of Hearing test program on smart~     phone for detected patients who has hearing loss.~   "
55521|NCT02840253|"~     Investigators have started an awake spinal anesthesia program in conjunction with pediatric~     surgical colleagues. Patients are offered the option of awake spinal anesthesia instead of~     general anesthesia for appropriate surgical procedures. Previous studies have demonstrated a~     lack of significant hemodynamic changes in neonates and infants following spinal anesthesia;~     however, there are limited data regarding its impact on tissue oxygenation. The goal of the~     current study is to assess changes in tissue and cerebral oxygenation using non-invasive near~     infrared spectroscopy following spinal anesthesia.~   "
55522|NCT02840240|"~     Opioids are effective analgesics, but cause side effects including sedation, respiratory~     depression, low blood pressure, nausea, and constipation. Gabapentin enacarbil, which is a~     FDA approved drug for post herpetic neuralgia (nerve pain related to shingles) and restless~     leg syndrome, may decrease your need for narcotics and thus decrease the risk of side~     effects. The investigator hopes this study will determine if gabapentin enacarbil decreases~     opioid consumption and pain after surgery.~      Patients having elective hip and knee surgery will be asked to participate in the study.~     Patients will be randomized to Gabapentin enacarbil 600mg twice per day for 5 days or Placebo~     twice per day for 5 days.~      One day prior to surgery the patient will take Gabapentin enacarbil 600mg or placebo 600mg~     twice a day with meals. On the day of surgery, the patient will take Gabapentin enacarbil~     600mg or placebo 600mg two hours before the surgical procedure. Six hours after the~     completion of surgery, the patient will receive Gabapentin enacarbil 600mg or placebo 600mg.~     If the patient is sent home, the patient will be given 6 Gabapentin enacarbil 600mg or~     placebo 600mg pills to take home along with instructions. However, if the patient remains~     hospitalized, on the first day after the surgery, the patient will have pain assessed in the~     morning using a numerical rating score. The patient's quality of recovery will be evaluated~     using a questionnaire and the patient will receive Gabapentin enacarbil 600mg or placebo~     600mg twice a day with meals. The second and third day the patient is in the hospital, the~     patient will have pain assessed in the morning using a numerical rating score and the patient~     will receive Gabapentin enacarbil 600mg or placebo 600mg twice a day with meals. Then, three~     months after surgery, the patient will receive a phone call to follow-up with possible pain~     or discomfort the patient may be feeling.~   "
55523|NCT02840227|"~     The primary hypothesis is that disease-free survival is improved in patients undergoing~     resection for tumor thought to be stage I-III primary non-small cell lung cancer in patients~     with combined general-epidural anesthesia & analgesia as compared to patients receiving~     general anesthesia and postoperative patient-controlled opioid analgesia. Patients having~     surgery for resection of potentially curable lung cancer will be randomized to combined~     general and epidural anesthesia or general anesthesia with opioid analgesia. The primary~     outcome will be disease-free survival.~   "
55524|NCT02840214|"~     This research project is focusing on changes in mental fatigue due to transcranial direct~     current stimulation (tDCS) in healthy individuals. The study aim is to see if mental fatigue~     can be rescued by administering a safe dose of tDCS. tDCS has been shown to decrease fatigue~     in healthy individuals experiencing extended wakefulness, and the investigators aim to~     investigate if similar results can be found in a fatigue inducing task. This is a~     single-blind randomized control trial that will compare mental fatigue between tDCS treatment~     and sham treatment groups through both subjective and objective measures. Objective fatigue~     will be measured by reaction time with the Stroop test and subjective fatigue will be~     measured by the multidimensional fatigue inventory questionnaire.~   "
55525|NCT02840201|"~     This is a sub-study of the ARTESiA study registered as NCT01938248. This study is designed to~     validate biomarkers in subclinical atrial fibrillation and to determine if the prospective~     biomarker will be informative of the potential efficacy of treatment.~   "
55526|NCT02840188|"~     The aim of this project is to evaluate retrospectively goalkeeper's fractures in children~     using the children fracture classification and to evaluate the distal radius tilt angle of~     the growth plate on plain radiographs of the forearm.~      Patients positive for goalkeeper's fracture will prospectively answer a questionnaire~     concerning risk factors and circumstances during the injury.~   "
55536|NCT02840058|"~     Recent scientific advances have shown the important role of immune system against cancer.~     Today, many immunological biotherapy like anti-PD1/PDL-1 are available in cancer treatment~     and generate durable clinical responses in some patients. The development of tools for~     monitoring anti-tumor immune responses dynamically is a major challenge to predict the~     effectiveness of immunotherapies anti-PD-1 and anti-PDL-1.~      Thus, the objective of our study is to analyse the interest of the monitoring of~     anti-telomerase T helper 1 (TH1) responses in predicting the efficacy of immunotherapy, using~     an immunoassay developed by our group.~   "
55528|NCT02840162|"~     This study will seek to determine if the downstream effects of cyclooxygenase-2 (COX-2)~     inhibition suggested by preclinical systems occur in human prostate cancer. To answer this~     question, men who have chosen prostatectomy will be randomly assigned to preoperative~     treatment with celecoxib or placebo for four weeks. Carefully collected tumor, premalignant,~     and benign prostate tissue will then be examined for apoptosis, androgen receptor and~     prostaglandin E2 levels. Tumor COX-2 expression will be correlated with observed treatment~     effects. The data generated by this study will serve as a foundation for the development of~     COX-2 targeted therapies for prostate cancer, will provide preliminary evidence for larger~     scale clinical trials aimed at treatment and prevention of prostate cancer, and will validate~     current preclinical models used to study COX-2 in prostate cancer.~   "
55529|NCT02840149|"~     Positron emission tomography/computed tomography (PET/CT) is an advanced nuclear medicine~     scan. This technology allows precise and early cancer to be visualized and measured on whole~     body images. Patients with Neuro-Endocrine tumors (NETs), require specialized molecular~     imaging to stage, re-stage and assess eligibility and response to therapy. 68Ga-DOTATATE is a~     nuclear medicine imaging agent that is not yet approved by Health Canada but used extensively~     throughout the world. The Ki-67 index, a marker of cell proliferation in NETs, is one of the~     most important prognostic factors in this disease. The objective of this study is to evaluate~     if the maximal standard uptake value (SUVmax) on PET/CT in NETs inversely correlates with~     Ki-67 score on initial biopsy. If this hypothesized correlation between SUV and Ki-67 score~     is reproduced, then DOTATATE would serve as a non-invasive method to assess cellular~     proliferation and therefore prognosis of these patients.~   "
55530|NCT02840136|"~     In this trial, various factors that may influence the antibiotic concentrations measured in~     the sputum of cystic fibrosis patients are studied.~      A first factor is aerosol use. As cystic fibrosis patients often use aerosols, such as~     hypertonic saline, dilution of the antibiotics in sputum can be expected. The extent of this~     dilution is unknown and will be determined by comparing sputum samples collected before and~     after the use of an aerosol.~      A second factor is the homogeneity of the antibiotics within one sputum sample. Multiple~     aliquots of the same sputum sample will be compared.~      A third factor is the variability between several sputum samples collected during a drainage~     session. The antibiotic concentrations in 3 separate sputum samples will be compared.~      The final goal is to standardise the sputum sample collection and processing of the samples~     to ensure a accurate concentration measurements in sputum.~   "
55531|NCT02840123|"~     The purpose of this study is to asses safety of diffuse intrinsic pontine glioma (DIPG)~     treatment with autologous dendritic cells pulsed with lysated allegenic tumor lines~      Evaluate the nonspecific immune response generated in peripheral blood and Cerebral Spinal~     Fluid (CSF) by proposed treatment Evaluate the specific antitumor immunity response generated~     in peripheral blood and CSF Assess overall survival and progression free survival Correlate~     the neuroradiological changes with the clinical course and immune response generated in~     peripheral blood and CSF Quality of life evaluation~   "
55532|NCT02840110|"~     Subjects treated with ACTR087 may participate in this long-term follow-up study after the~     completion of the final scheduled visit in the parent clinical study or other investigational~     setting, such as compassionate use, named patient IND, expanded access program, or equivalent~     setting. No investigational product or treatment will be administered in this study. These~     subjects will be followed for safety monitoring on a schedule of decreasing frequency through~     15 years post-ACTR087 treatment, in accordance with US FDA Regulatory guidance pertaining to~     long-term safety follow-up for study subjects receiving recombinant DNA-containing~     investigational products.~   "
55533|NCT02840097|"~     Trauma is the leading cause of death and disability in children in the United States. The~     long-term goal of this project is to evaluate the benefits and harms of tranexamic acid (TXA;~     a drug that stops bleeding) in severely injured children. This is a 40-patient pilot study to~     evaluate the feasibility of two subsequent large-scale studies of TXA in injured children.~   "
55534|NCT02840084|"~     Purpose: The purpose of this investigation is to test the safety and effectiveness of the~     Aspen System™ and Aspen Rehabilitation Technique. The device is intended for the therapeutic~     treatment of capsular contracture of the breast in conjunction with the Aspen Rehabilitation~     Technique. The hypothesis of the proposed study is that external ultrasound with the Aspen~     System™ device in conjunction with the Aspen Rehabilitation Technique is safe and effective~     in the reduction by at least one level of Baker Grade III capsular contracture in cosmetic~     breast augmentation patients, maintained at one year from the final treatment. Potential~     benefits of the study to subjects include improvement in the grade of capsular contracture of~     the breast without surgical treatment. The investigation is planned to last 12 months.~   "
55535|NCT02840071|"~     Title: Acceptance and Commitment therapy for Individuals with Head and Neck Cancer~     Experiencing Psychological Distress.~      Head and neck cancer (HNC) patients are particularly vulnerable to experiencing psychological~     distress . The current guidelines from the National Institute of Health and Care Excellence~     are that cognitive-behavioural therapy (CBT) is to be offered to adults with a long-term~     physical health condition experiencing anxiety and depression. CBT has been shown to have~     several inadequacies for individuals with physical health conditions such as cancer.~     Acceptance and commitment therapy (ACT) takes an alternative approach to CBT, aiming to~     change a person's interaction with their thoughts rather than suppress or alter thought~     content. Although studies indicate encouraging findings for the effectiveness of ACT for~     individuals with breast cancer; the HNC- transfer-ability of findings is yet untested, and~     there is a need to evaluate the replicability of ACT effects in people living with HNC, given~     the unique challenges inherent to the disease and its treatment.~      This study aims to inform clinical practise by using a hermeneutic single-case efficacy~     design (HSCED) to answer the following questions:~        1. Is there evidence of psychological change after the introduction of the ACT~          intervention?~        2. If present, are the changes attributable to (a) ACT components, (b) common factors,~          and/or (c) non-therapeutic factors?~      The study will involve recruiting three adults with HNC from specialist HNC psychology~     services. Each participant will have six individual sessions of ACT and complete various~     process and outcome questionnaires during sessions. Following the intervention, participants~     will have a semi-structured interview where their views of the therapy and any changes made~     will be explored. Two outcome measures will be posted to participants at 1-month and 3-month~     post intervention.~   "
55537|NCT02840045|"~     The purpose of this study is to use a new method to differentiate mnesic abilities of early~     alzheimer patients and patients with a depressive disorder.~      This method is based on the recording of cerebral activity while patients listen to familiar,~     unfamiliar and newly-learned music.~   "
55538|NCT02840032|"~     Bedside ultrasonography for detection of pneumothorax after transbronchial lung biopsies in~     lung transplant patients~   "
55540|NCT02840006|"~     CONTEXT: In patients eligible for coronary artery bypass surgery, anesthesia should provide a~     number of conditions that exceed the limits of cardiovascular stability, myocardial~     protection and other organs. Moreover, the combination of general anesthesia and spinal~     anesthesia lessens the homeostatic, metabolic, hormonal and immunosuppressive changes. The~     goal of this research was to evaluate the consumption of fentanyl citrate in intra-operative~     in Coronary Artery Bypass Grafting (CABG) surgery with cardiopulmonary bypass under spinal~     anesthesia associated with general anesthesia.~      METHODS: Clinical, prospective, randomized and double covered study, approved by the Research~     Ethics Committee. Fifty-six patients candidates for CABG with CPB, after signing the Terms of~     consent, were randomized and divided into two groups: GI - General and GII - General +~     subarachnoid. General anesthesia was induced according to the weight of each patient and~     maintenance with isoflurane and fentanyl. Spinal anesthesia was induced with 20 mg of 0.5%~     hyperbaric bupivacaine and 200 mcg of morphine, the patient is placed in cephalo-position~     slope of 45 degrees for 10 minutes in Group II. In the statistical study was performed using~     the Mann-Whitney test; the level of statistical significance was set at 5%.~   "
55541|NCT02839993|"~     The aim of this study is to investigate whether a tDCS-accompanied training of audio-visual~     associative memory leads to a performance improvement in healthy older individuals.~   "
55542|NCT02839980|"~     In this prospective observational multicenter study we aim to determine the prevalence of~     oropharyngeal and rectal Gram-negative bacilli colonization in 4 population of hospitalized~     subjects, and their susceptibility to chlorehexidine. We plan to recruit 300 subjects in~     surgical wards (100 in orthopedics, 100 in thoracic and vascular, 100 in abdominal surgery)~     and 100 in the ICU. Secondary endpoints are to determine the incidence of the acquisition of~     such colonization in a 10-day timeframe; determine the phylogentic characteristics of E. coli~     isolates; to compare the phylogentic characteristics of oropharyngeal and rectal E. coli~     isolates; to compare the phylogentic characteristics of colonization and potential E. coli~     infection isolates; to compare the rectal and oropharyngeal colonization composition;~     description of oropharyngeal microbiote~   "
55543|NCT02839967|"~     According to the International Association for the Study of Pain (IASP), the~     temporomandibular pain and dysfunction syndrome (TMD) is characterized as a subset of~     orofacial pain, whose signs and symptoms include pain or discomfort in the temporomandibular~     joints. Pain is considered one of the most common and limiting clinical manifestations. One~     of the most used resources to treat muscle pain is the low-level laser therapy (LLLT),~     However, the mechanisms responsible for the effects observed in clinical trials remain poorly~     elucidated, as well as therapy with light emitting diode therapy (LEDT) which, has some~     advantages, among them the larger area radiation point and low cost. However, its effects~     remain elusive in intraoral application in temporal muscle, lateral and medial pterygoid~     muscle. Assuming that there is need to investigate therapeutic resources that combine not~     only different wavelengths as well as different light sources (LED and LLLT), this study aims~     to evaluate the effect of photobiomodulation with a combination of different light sources on~     pain, joint mobility, equity and quality of jaw movements after treatment in patients with~     TMD. It will be made a randomized, placebo-controlled and double-blind clinical trial.~     Individuals participate with myogenic temporomandibular disorder, being allocated into 2~     groups randomly and stratified by the method of sealed envelopes. The results will be~     evaluated using: RDC/TMD, digital caliper, visual analog scale, and kinematics. The protocols~     will be used in a 6 sessions and will be evaluated in four different moments. The analyses of~     the data will be performed by adopting a significance level of 5%.~   "
55544|NCT02839954|"~     The purpose of this study is to evaluate the safety and effectiveness of CAR-pNK cell~     immunotherapy in patients with MUC1 positive relapsed or refractory solid tumor.~   "
55545|NCT02839941|"~     The objective of the study is to evaluate the effect of iguratimod concomitant with~     conventional immunosuppressive drugs on preventing antibody-induced rejection in HLA Highly~     mismatched Kidney Transplant recipients.~   "
55546|NCT02839928|"~     Nasal Ketamine has previously been tested in children for deep sedation or preoperative~     anxiolysis. The investigators intend to test the efficacy of low dose nasal Ketamine in~     children undergoing minor procedures in the emergency department.~   "
55547|NCT02839915|"~     The purpose of this study is to determine the effectiveness of folinic acid in the treatment~     of language problems in children with autism spectrum disorder. Folinic acid, also known as~     leucovorin, is approved by the U.S. Food and Drug Administration (FDA) to decrease side~     effects during cancer chemotherapy. Folinic acid may be helpful in treating language problems~     in children with autism spectrum disorder, but this is not known. Therefore, folinic acid is~     an investigational new drug for this study.Investigators will enroll up to 60 participants in~     this study at the Marcus Autism Center over 5 years and a total of 160 participants across~     all three centers. Participation will last between 12 - 24 weeks~   "
55548|NCT02839902|"~     The purpose of this study is to explore the effects of 8-week treatment with omega-3-acid~     ethyl esters on the lipid and lipoprotein profile in the blood in hyperlipidemic patients~     receiving a HMG-CoA reductase inhibitor by use of HPLC in comparison with the control group~     of patients not treated with omega-3-acid ethyl esters.~   "
55549|NCT02839889|"~     The purpose of this study is to determine if naloxegol can be used in the treatment of~     opioid-induced constipation in patients with cancer and pain. This phase 4 study consists of~     a two week randomized double blind period followed by a two week open-label period.~   "
55550|NCT02839876|"~     The purpose of this study is to determine if intravenous acetaminophen is superior to oral~     acetaminophen when used as part of a multimodal pathway for primary total hip arthroplasty.~   "
55567|NCT02839655|"~     The robot-assisted surgery for benign and malignant thyroid tumors was widely developed in~     Asia and begins to spread in Western countries. The main advantage of the technique is to~     avoid a scar in the neck by placing it either in the axilla or at the hairline behind the ear~     to improve esthetic consequences and body image. It is not surgery minimally invasive but~     rather a way of remote access surgery.~      Data from the literature including cohort studies and meta-analyzes attest the security of~     the procedure in comparison with classic thyroid surgery (which remains the gold standard).~     However there is few data on the effectiveness of the technique in terms of the completeness~     of the surgery, according to the routine standard criteria used in endocrinology and~     endocrine cancer, and no French medico-economic study has been performed.~   "
55551|NCT02839863|"~     Due to better treatment options and earlier detection, survival rates of patients with breast~     cancer continue to increase. As such, (late) treatment toxicity, (long-term) quality of life~     and the cosmetic outcome are becoming more important. Also, many competing experimental~     interventions (e.g. treatment, lifestyle interventions) for breast cancer are being~     developed, all in need to be properly evaluated before being implemented in routine clinical~     care. Randomized Controlled Trials are the gold standard to do so, but they have shown many~     challenges, especially when applied in a cancer setting. The 'cohort multiple Randomized~     Controlled Trial (cmRCT)' design is a promising design for multiple (simultaneous) randomized~     evaluations of experimental interventions, with potential for increased recruitment,~     comparability and long-term outcomes as a standard.~      By setting up UMBRELLA, as a prospective cohort according to the cmRCT design, the~     investigators aim to:~        -  provide an infrastructure for efficient, fast and pragmatic evaluation and~          implementation of experimental interventions~        -  gain insight into short and long-term treatment response, toxicity, complications,~          quality of life and survival of patients with breast cancer.~   "
55552|NCT02839850|"~     The primary objective of this study is to examine the change from pre-operative baseline to~     two year postoperative functional performance improvement for the ATTUNE primary, cementless~     TKA RP system as measured with the KOOS questionnaire (KOOS-ADL sub-score). This will be~     carried out for two configurations: cruciate retaining rotating platform (ATTUNE Cementless~     CR RP) and posterior stabilized rotating platform (ATTUNE Cementless PS RP).~   "
55553|NCT02839837|"~     Depression is associated with a disruption in the mechanisms that regulate neuroplasticity.~     Effective treatment and rehabilitation of depression, and other neurological and~     neuropsychiatric disorders, relies on neuroplasticity. Thus, identifying therapies that~     enhance neuroplasticity (neuroplastic adaptation) are vital in the comprehensive treatment of~     depression. Aerobic exercise training has been demonstrated to have antidepressant properties~     and single bouts of aerobic exercise may provide short-term improvements in affective states~     in depression. Furthermore, acute aerobic exercise may enhance the response to known~     neuroplasticity-inducing paradigms. However, it is unclear if aerobic exercise can influence~     neuroplasticity in depression and the neurobiological mechanisms underlying acute~     neuroplastic changes are not well understood in depressed and healthy cohorts. Thus, the~     purpose of this project is to examine the acute effects of aerobic exercise on neuroplastic,~     neurobiological, and mood indices of depression.~   "
55554|NCT02839824|"~     Publications of the use of bowel cleansers in usual clinical practice are lacking. Patient~     adherence to investigational products increases in the context of clinical trials. By the~     same token, efficacy of interventions may be overestimated in clinical trials.~      For this reason, an observational study to collect data on the effectiveness of several~     colonic preparations when these are used under usual clinical practice is proposed.~   "
55555|NCT02839811|"~     The COBIOPHAD project targets the development of a highly sensitive, selective, and~     multiplexed diagnostic device to provide a quick and inexpensive in vitro test to address the~     most prevalent drug hypersensitivity to betalactams antibiotics, (BLCs). During a~     retrospective study, BLC structures involved in drug hypersensitivity will be identified from~     sera of allergic patients (versus controls) and coupled on the device.~      A prospective study will be performed for the recruitment of samples corresponding to~     patients with known IgE hypersensitivity to BLCs based on results from allergy tests and~     clinical history. Controls will include: non-allergic individuals with known tolerance to~     betalactams. The samples will be used for the validation of the COBIOPHAD device in real~     settings.~   "
55556|NCT02839798|"~     This study is designed to evaluate the safety and preliminary efficacy of synchronized~     transcranial magnetic stimulation (sTMS) using the NeoSync EEG Synchronized TMS device (NEST)~     in subjects with Bipolar Disorder type I in a Major Depressive Episode. This is an open label~     study in which subjects will receive treatment 5 days per week for 6 weeks.~   "
55557|NCT02839785|"~     SPARCLE 1 and 2 studies followed a cohort of 818 children with cerebral palsy (CP) between 8~     and 12 (SPARCLE 1) and 13 and 18 years old (SPARCLE 2) interviewed at home. The prevalence of~     pain in these populations was respectively 60 and 69% while it is about 35% in typically~     developed children of the same age.~      The main location of the pain for 60% of children with CP was the lower limbs, caused by~     musculoskeletal pain and movement (for those who can) and therapeutic procedures. In SPARCLE~     2, 50% of the children complained about pain during physical therapy.~      If the pain is part of the management of physiotherapy, a recent review showed that for a~     condition such as chronic back pain, the level of evidence of the effectiveness of~     physiotherapy techniques in reducing pain is low. The effectiveness of these techniques would~     include higher efficacy on anxiety than pain itself.~      Despite significant involvement of physiotherapists in the management of pain, the focus on~     pain should increase, in particular taking into account the procedural/induced pain (caused~     by treatment).~      In addition to drugs, physical methods (analgesic therapy) or psychotherapy are used to~     reduce the pain of children during medical procedures. For the latter most of them require~     the presence of two individuals to provide the therapy. This is unsuited for out-patient care~     provided to the majority of children with CP.~      Non steroid anti-inflammatory drug (NSAIDs), are first recommended, alone or in combination~     with the treatment of several indications in child pain (migraine, postoperative pain, etc.).~     Ibuprofen is commonly used in children during painful procedures and represented the 4th~     molecule among prescribed per os analgesic drugs in 2008 in the United States.~   "
55558|NCT02839772|"~     An RCT (n=193) in two podoconiosis clinics in Ethiopia to evaluate the effectiveness of a~     research based skin management regimen compared to the current regimen. The experimental~     group added 2% glycerine to the current skin care regimen and used 1 litre of water in the~     water soak compared to the 6 litres used in the current regimen.~   "
55559|NCT02839759|"~     This RCT will have two arms: A control group that receives the standard of care from~     audiologists and an experimental group that receives both the standard of care and the~     at-home use of the TELLYHealth intervention. Subjects in each group will complete~     questionnaires at enrollment, mid-study and at the end of the study.~   "
55560|NCT02839746|"~     Describe patient and physician assessed factors for patient well-being when treated with~     Pradaxa for stroke and embolism prevention in atrial fibrillation either compared to previous~     antithrombotic treatment (switcher)~   "
55561|NCT02839733|"~     Background:~      Cerebral palsy (CP) is the most common childhood motor disability. The neurotransmitter~     dopamine (DA) is important in cognition and emotions/behavior. DA may also be important in~     motor skill learning. Genes that relate to DA function may affect a person s ability to learn~     new cognitive or motor skills. Some children with CP can learn motor skills easily while~     others have trouble. Researchers want to find out if DA gene variations cause some of this~     variability.~      Objectives:~      To learn more about how DA and its related genes affect motor and cognitive learning in~     people with and without CP.~      Eligibility:~      People ages 5 25 with and without CP who can:~      Follow the protocol~      Attend and perform the training sessions~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Blood draw for genetic tests~      The study has 2 parts. Participants with CP can join both. Those without can join only Part~     1.~      All participants will have a baseline assessment: short motor skills test and blood draw.~      Part 1:~      Two 10-session training programs over 2 weeks. Cognitive training will be 2 sessions at the~     clinic, 8 at home. Participants will perform memory tasks on a computer. All 10 motor~     training sessions are at the clinic. Participants will step on lines in a virtual reality~     environment.~      Part 2:~      Two lab training sessions at least 1 week apart. Participants will perform tasks on a~      computer.~      Participants with CP may have a brain MRI at 1 visit. They will lie on a table that slides~     into a machine that takes pictures. They will be in the scanner about 45 minutes. They may~     have a~   "
55562|NCT02839720|"~     This pilot phase II trial studies how well selumetinib works in treating patients with~     neurofibromatosis type 1 and cutaneous neurofibromas. Selumetinib may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth.~   "
55563|NCT02839707|"~     This randomized phase II/III trial studies how well pegylated liposomal doxorubicin~     hydrochloride with atezolizumab and/or bevacizumab work in treating patients with ovarian,~     fallopian tube, or primary peritoneal cancer that has come back. Drugs used in chemotherapy,~     such as pegylated liposomal doxorubicin hydrochloride, work in different ways to stop the~     growth of cancer cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. block tumor growth Monoclonal antibodies, such as atezolizumab~     and bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not~     yet known which combination will work better in treating patients with ovarian, fallopian~     tube, or primary peritoneal cancer.~   "
55564|NCT02839694|"~     Background:~      Most patients who have surgery for cancer that has metastasized (spread) to the lungs later~     get more metastases that cannot be treated with surgery or chemotherapy. The drug resistance~     may be due to DNA changes in cancer cells that activate some genes and turn others off.~     Researchers want to test a combination of drugs for people with metasteses. Decitabine (DAC)~     may reverse the DNA changes. Tetrahydrouridine (THU) makes DAC last longer. Celecoxib may~     slow the progression of cancer.~      Objectives:~      To determine a safe dose of DAC and THU by mouth. To see if DAC-THU with or without celecoxib~     reactivates genes in lung metastases.~      Eligibility:~      Adults 18 years and older, with cancer in both lungs that can be treated with surgery.~      Design:~      Participants will be screened with:~      Blood, lung, and heart tests~      Scans~      Tests for viruses~      Pregnancy test~      Participants will have blood and stool tests.~      They will have surgery to remove metasteses in 1 lung.~      About 3 weeks later, they will have lung scans. If the disease is not back, participants will~     get DAC and THU with or without celecoxib, by mouth for 6 weeks.~      Participants will have more scans. If the disease is not worse, they will continue the study~     drugs for 4 more weeks.~      Participants will have more scans and heart and lung tests. They will have surgery to remove~     metasteses from the other lung.~      Participants will have weekly blood and urine tests, plus several blood draws the first 2~     days of taking the drugs.~      Participants will have exams and blood tests before each surgery.~      Participants will have follow-up visits 1 and 3 months after the second surgery.~   "
55565|NCT02839681|"~     Background:~      Anetumab ravtansine is a new drug. It kills cancer cells that carry mesothelin. That is a~     protein on the surface of tumor cells in many types of tumors, including most lung cancers.~     Researchers want to find a safe dose for the study drug for lung cancer. They want to see if~     it can shrink tumors in mesothelin-positive lung cancer.~      Objectives:~      To test the safety and effectiveness of anetumab ravtansine for lung cancer.~      Eligibility:~      Adults 18 years and older who have lung cancer that has gotten worse on other therapy~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Tumor tissue sample. This can be from a previous procedure.~      Blood and urine tests~      Heart tests~      Scans. For one scan, a small amount of radioactive substance is injected into the blood.~      Eye exam~      The study will have 21-day cycles.~      On day 1 of each cycle, participants will get the study drug through a tube inserted in a~     vein.~      Participants will repeat a heart test in cycles 1 and 2.~      They will have blood tests weekly in cycle 1, twice in all other cycles.~      They will have scans every 6 weeks for the first 6 months, every 9 weeks until the end of~     year 2, then every 12 weeks.~      Participants will have samples of tumor tissue taken twice.~      About 30 days after stopping the study drug, participants will have a follow-up visit. This~     will include medical history, physical exam, blood and pregnancy tests, and heart and eye~     tests.~      Some will be called a few times a year to discuss their health and treatment.~   "
55566|NCT02839668|"~     Because neoplastic disease is one of the leading causes of death worldwide and breast cancer~     is one of the most frequent neoplasia among women, the possibility of influencing the~     evolution of patients starting from the moment of surgical intervention using a~     perianesthesic intervention is a scientific topic of high interest. The study will compare~     two anesthetic techniques and their efficiency in lowering the factors that can favorize the~     dissemination of neoplasia and their role in the prevention of postoperative pain. The serum~     level of vascular endothelial growth factor A (VEGF-A) will be determined before and after~     the surgical intervention after using two different types of anesthesia (inhalational and~     intravenous), and the immunohistochemical expression of vascular endothelial growth factor~     receptors (VEGFR) will be determined on the excised tissue. For the two different types of~     anesthesia a continuous infusion of lidocaine 1% will be associated. The study will compare~     the short-term and long term-outcome of the patients assigned the two different types of~     anesthesia and their immediate postoperative evolution .~   "
55734|NCT02837484|"~     This study was designed to evaluate the long term effectiveness of a product used in knee~     surgery called Affinity™ Membrane.~   "
55568|NCT02839642|"~     Progressive supranuclear palsy (PSP) is a rare neurodegenerative disease from the~     parkinsonian syndrome group. It represents 5 to 10% of all parkinsonian syndromes and affects~     3,000 to 10,000 persons in France. PSP is characterised by a doparesistant parkinsonism with~     axial signs such as early gait instability and falls, oculomotor signs such as a vertical~     gaze palsy, dysphagia and dysarthria, and both cognitive and behavioural disturbances. The~     latter predominantly manifest as psycho-motor slowness, apathy and frontal executive~     deficits. Swallowing impairments and falls may lead to life-threatening situations and death~     occurs 6-9 years after disease onset.~      Apart from L-dopa which may transiently and inconsistently improve motor symptoms no~     effective symptomatic, disease-modifying or neuroprotective therapy is presently available to~     reduce disability in any way. Therefore these patients often receive mostly non-medical care~     such as physiotherapy and speech therapy.~      In addition to dopaminergic degeneration there is evidence of cholinergic deficits in PSP~     correlated with gait and balance impairments . This stands in contrast with the limited~     number of studies of cholinergic augmentation strategies in PSP.~      Trials of cholinesterase inhibitors in PSP have produced rather conflicting results:~     donepezil improves cognition but deteriorates some motor functions whereas a case series of 5~     PSP patients treated with rivastigmine found an improvement in several cognitive aspects and~     no deterioration of motor functions .On the other hand in Parkinson's disease there is~     convincing evidence of a positive effect of rivastigmine on cognition , apathy and falls~     Investigators' hypothesis is that rivastigmine (an acetyl- and butyryl-cholinesterase~     inhibitor) may reduce gait and postural impairment in PSP and may therefore limit the number~     of falls and their consequences both in terms of injuries sustained (fractures etc...) and on~     the patients' autonomy. In addition investigators hypothesise that rivastigmine may also~     reduce the cognitive and behavioural impairment associated with PSP. Taken together these~     improvements are likely to produce a significant effect on the patients' quality of life and~     their caregiver burden.~   "
55569|NCT02839629|"~     A study to describe and evaluate patient characteristics and clinical outcomes in Subjects~     with diagnosed Non Small Lung Cell Cancer in Sweden, Norway and Denmark.~   "
55570|NCT02839616|"~     The Institutional Registry of Liver Transplantation is a system for data collection related~     to patients with liver disease who are possible candidates for liver transplantion. This tool~     was designed by a multidisciplinary team that includes hepatologists, surgeons, informatics~     and biostatisticians. It intends to collect the information from the clinical evaluation,~     physical examination, complementary diagnostic methods and laboratory data. The information~     is captured sistematically, following structured, standardized and monitored processess to~     ensure the quality of the data obtained.~      The aim is to use the available technology to generate a complete database that can be used~     to answer research questions.~   "
55571|NCT02839603|"~     To collect pilot data on the prevalence and incidence of asymptomatic Leishmania donovani~     infection in HIV infected individuals in a visceral leishmaniasis (VL)-HIV endemic region to~     inform the feasibility of a larger study exploring a screen and treat strategy for VL in HIV~     co-infected individuals in East-Africa (Ethiopia).~   "
55572|NCT02839590|"~     There are currently many surgical options for patients with glaucoma and ocular hypertension~     (OHT), including the Hydrus Microstent implant, HiFU (High intensity Focused ultrasound),~     STAR flo, Kahook Dual Blade, Diode laser, trabeculectomy and the Baerveldt implant, but~     little is known about how these different surgical techniques used to treat glaucoma affect~     the flow of fluid through and out of the eye (aqueous dynamics).~   "
55573|NCT02839577|"~     The aim of the study is to determine the effect of steroid in High Volume Injection (HVI)~     compared to HVI without steroid (volume effect) in functional outcomes and ultrasound tendon~     thickness and Color Doppler activity in chronic Achilles tendinopathy (AT).~      Healthy males with AT will be randomly assigned to either 1) HVI with steroid (50 mls;10 mls~     0.5% bupivacaine hydrochloride and 20 mg of Depomedrol followed by 40 ml saline) or 2) HVI~     without steroid (50 mls;10 mls 0.5% bupivacaine hydrochloride followed by 40 ml saline).~      All subjects will perform a 12-wk eccentric training program with further eccentric training~     3 times per week from week 12 to week 24.~      Clinical examinations and ultrasound will be performed at baseline (before treatment) with~     follow-ups after 6 weeks, 12 weeks and again after 24 weeks prior to baseline to see any~     possible changes and differences between the two groups.~   "
55574|NCT02839564|"~     Laparoscopic adhesiolysis as a therapy for chronic pain is still controversial and long term~     effects are not known. The objective was to to evaluate long term effects of laparoscopic~     adhesiolysis for treating chronic abdominal pain.~      Therefore one hundred patients with abdominal pain attributed to adhesions were randomized to~     laparoscopic adhesiolysis or a placebo group with laparoscopy alone. Pain relief was assessed~     after 3, 6 and 12 months and 12-year follow-up.~   "
55575|NCT02839551|"~     Drug provocation tests (DPT) are widely in case of suspicion of drug hypersensitivity (and in~     the absence of contraindications), but there are no standardized protocols and most groups~     use hypothesis (clinically-driven) protocols.~      investigators used 20 year experience in drug hypersensitivity to analyse retrospectively 171~     patients (accounting for 182 positive DPT to beta-lactams). Using survival analysis, they~     identified optimal doses to include in a data-driven protocol. This data-driven protocol will~     be applied to new prospective patients, to test its safety and benefits (gain in time,~     hospital and patient benefits).~   "
55576|NCT02839538|"~     Background and Objectives: Postoperative analgesia and early recovery are relevant for~     hospital discharge after hemorrhoidectomy. This study investigated the postoperative~     analgesic effect with local infiltration compared with spinal block.~      Methods: This randomized study included 40 patients aged 18 to 60 years old. Local group (LG)~     received local infiltration under general anaesthesia; spinal group (SG) received a~     subarachnoid block. LG received general anaesthesia with propofol, atracurium and propofol~     infusion as well as a local infiltration of 20 ml 0.75% ropivacaine. SG received 2 ml of 0.5%~     hyperbaric bupivacaine. Analgesic supplementation was with 50µg of fentanyl for LG and 1%~     lidocaine for SG. There were assessed: postoperative pain intensity, sphincter relaxation,~     motor blockade of lower limbs, time to discharge, analgesic dose over 1 week and adverse~     effects.~   "
55577|NCT02839525|"~     The study is a randomized, double-blinded, placebo-controlled trial that will include the~     participation of 69 women, aged 18-40 years. The aim of the study is to test nutritional~     strategies that help to minimize the effects of muscle damage induced by exercise.~      The procedures will be performed at the Federal University of Health of Porto Alegre~     (UFCSPA).~   "
55578|NCT02839512|"~     This is a single center study to assess metabolic effects in subjects after a Jejunal to~     Ileal Diversion procedure was performed using colonoscopes.~   "
55735|NCT02837471|"~     The purpose of this prospective randomized controlled trial (RCT) is to evaluate the~     feasibility and usability of a commercial pedometer and web application in a case-managed~     home-based Cardiovascular disease prevention and rehabilitation program for French-speaking~     Canadians.~   "
55579|NCT02839499|"~     Obstructive sleep apnea is a condition that affects 40% to 62% of the population aged over 60~     years with major consequences especially on the cardiovascular system.~      This syndrome consists of a staff of the pharyngeal muscles. These muscles are also involved~     in swallowing phenomena and chews, or many elderly patients are subjected to a mixed diet,~     logically leading to atrophy of the muscles aerodigestive crossroads.~      Muscle wasting ENT induced a mixed food could promote collapsibility of VAS, exposing the~     individual to a higher risk of apnea and hypopnea during sleep.~      The objective of this study is to determine if there is a significant increase in the~     prevalence of obstructive sleep apnea syndrome in the elderly patients residing in long term~     care units, receiving a mixed food compared to residents in supply to normal texture.~   "
55580|NCT02839486|"~     The aim of this study will be to evaluate vancomycin and cefoxitin blood levels during~     elective cardiopulmonary bypass (CPB) surgery in four pre-determined pediatric strata:~     neonates, infants, children weighting less than 40 kg and children weighting more than 40 kg.~   "
55581|NCT02839473|"~     The primary objective consisted of avoiding deterioration and/or restoring the integrity of~     the skin of patients treated by radiotherapy, right from the first signs of grade 1 or 2~     radiation dermatitis.~   "
55582|NCT02839460|"~     This is a single center, prospective biomarker study to evaluate serum levels of TWEAK and~     expression levels of TWEAK and Fn14 in muscle biopsies from patients with sarcopenia as well~     as healthy, physically active controls.~   "
55583|NCT02839447|"~     The purpose of this study is to determine if elevations in oxidative stress, as measured by~     oxidation-reduction potential (ORP), can distinguish between semen samples from men with~     abnormal semen parameters from those with normal semen parameters. Static ORP (sORP) results,~     measured by the MiOXSYS System- a novel technology, will be compared to the current World~     Health Organization (WHO) semen analysis parameters (5th Edition WHO Laboratory Manual for~     the Examination and Processing of Human Semen [2010]).~   "
55584|NCT02839434|"~     Oral anticoagulants are increasingly prescribed and the are not discontinued for invasive~     cardiac procedures .~      Additional parenteral anticoagulation is necessary for these procedures (FA ablation and~     invasive coronary explorations).~      The unfractionated heparin doses are adapted on a monitoring test heparin, activated clotting~     time (ACT) with the aim of obtaining and maintaining an ACT > 300-400 sec. This goal is the~     same whether the patient is on oral anticoagulant treatment or not, and regardless of the~     initial level of anticoagulation.~      The effects of oral anticoagulants on routine coagulation tests (PT, APTT, TT) are well~     documented, but few data have been published on the effects of heparin monitoring tests,~     particularly on the ACT.~      The aim of this stuy is to redefine the target values of ACT and unfractionated heparin doses~     to administer to optimize the efficacy / safety of invasive procedures in cardiology.~   "
55585|NCT02839421|"~     The aim of the present study is to evaluate the clinical and microbiological efficacy of~     moxifloxacin or amoxicillin plus metronidazole in one-stage scaling and root planing in~     treating generalized aggressive periodontitis. Forty five subjects will be randomly allocated~     to 3 treatment groups. Subgingival plaque samples will be analysed for cultivable bacteria.~     The primary outcome variable to determine the superiority of one treatment over the others~     would be differences between groups for means CAL changes at 6 months post-treatment.~     Secondary outcome variables include differences between therapies for the mean changes in the~     mean levels of PD and the proportion of BOP.~   "
55586|NCT02839408|"~     The aim of this randomized placebo- controlled clinical trial is to evaluate the effects of~     Lactobacillus rhamnosus SP1- containing probiotic tablets and azithromycin tablets as an~     adjunct to scaling and root planning (SRP).~      Material and methods: Fifty-four chronic periodontitis patients will be recruited and~     monitored clinically, immunologically and microbiologically at baseline, 3, 6, 9 and 12~     months after therapy. All patients will receive scaling and root planning and randomly will~     be assigned over an probiotic experimental (SRP + probiotic, n=18), antibiotic experimental~     (SRP + Azithromycin, n=18) or control (SRP + placebo, n=18) group. Probiotic will be used~     once per day during 3 months. Antibiotic will be used once per day during 5 days.~   "
55587|NCT02839395|"~     The human eye has a dual role, which is reflected by the various photo-receptors used for~     vision of images and colors ,Image forming photoreceptors (IFP) and for entrainment of our~     Biological clock located in the hypothalamus through the retinal ganglions known as~     non-image forming photoreceptors (NIFP). The recently discovered new photo-pigment melanopsin~     which is sensitive to short wavelength (SWL) illumination exists in the-NIFP. The axons of~     the NIFP form a special nerve known as the Retino-hypothalamic-tract (RHT) that transfers the~     SWL signal to the biological clock resulting in suppression of pineal melatonin (MLT)~     production. This is the basic mechanism by which environmental light/dark cycles entrain the~     biological clock and transfer the message to organs, tissues and cell.~      The American Medical Association (AMA) issued a resolution in 2012 stating that light at~     night constitutes environmental pollution because it violates the daily cycles, including the~     waking and sleeping cycles, and suppresses the secretion of melatonin from the pineal gland~     at night. Results of other studies have shown that exposure to artificial light at night~     (ALAN) and mainly those emerging from SWL sources suppresses MLT-produced in the pineal~     gland. Computers, tablets, TVs, and smart-phones screens emit SWL illumination, during the~     day and night hours, whether as active or passive users. The results of previous studies show~     that, exposure to SWL-ALAN illumination suppresses MLT-secretion and disrupts sleep patterns.~     In order to understand better the effect of SWL-exposure emerging from screens on human~     behavior and health, the investigators will study the effects of SWL-exposure on the~     structure and quality of sleep, cognitive functioning in Continous Performance Test (CPT~     III), emotional state, and physiological, variables (melatonin secretion levels and body~     temperature) that were not tested in previous studies.~   "
55588|NCT02839382|"~     The purpose of this project is to build capacity for quality improvement (QI) in small~     primary care practices across Washington, Oregon and Idaho by improving risk factors for~     heart attacks such as blood pressure, cholesterol and smoking. The Northwest Coalition for~     Primary Care Practice Support will assist practices by providing them with a QI coach,~     creating group learning opportunities, and conducting educational outreach activities. An~     innovative study design will be used to determine what levels and types of support are most~     helpful and effective.~   "
55589|NCT02839369|"~     The goal of the present study was to look at the effect of changing walking parameters on the~     dynamic walking characteristics among children post severe traumatic brain injury, children~     with cerebral palsy and typically developed controls.~   "
55736|NCT02837458|"~     The purpose of this study is to determine whether the transcutaneous application of~     unmodulated high frequency alternating currents could produce a quickly conduction block of~     peripheral nerve.~   "
57270|NCT02817373|"~     This study is designed to predict implantation of a fresh, high quality embryo in an in vitro~     fertilization (IVF) cycle by using ultrasound based uterine factors.~   "
55590|NCT02839356|"~     Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) has been a~     well-recognized complication with significant morbidity and even mortality. A variety of~     possible mechanisms has been suggested in the occurrence of pancreatitis, but papillary edema~     caused by manipulations during cannulation or endoscopic treatment has received the most~     attention. The papillary edema may cause temporary outflow obstruction of pancreatic juice,~     and then increase ductal pressure, resulting in the occurrence of pancreatitis. Topical~     application of epinephrine on the papilla may reduce papillary edema. Moreover, it is~     reported that epinephrine sprayed on the papilla may be effective to prevent PEP. However, it~     is still unclear that epinephrine sprayed on the papilla can prevent acute pancreatitis after~     endoscopic retrograde cholangiopancreatography. We therefore designed a prospective~     randomized trial to determine whether epinephrine sprayed on the papilla prevent PEP after~     ERCP.~   "
55591|NCT02839343|"~     This randomized phase II trial studies how well combination chemotherapy (mFOLFIRINOX) with~     or without hypofractionated radiation therapy before surgery works in patients with~     pancreatic cancer that can be removed by surgery. Drugs used in combination chemotherapy,~     such as oxaliplatin, leucovorin calcium, fluorouracil, and irinotecan hydrochloride, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Hypofractionated radiation therapy~     delivers higher doses of radiation therapy over a shorter period of time and may kill more~     tumor cells and have fewer side effects. It is not yet known if combination chemotherapy is~     more effective with or without hypofractionated radiation therapy before surgery in treating~     patients with pancreatic cancer.~   "
55592|NCT02839330|"~     This Phase 3 study evaluates the safety, immunogenicity and lot-to lot consistency of 3 lots~     of aH5N1c vaccine for pandemic avian influenza, in approximately 2394 healthy adults ≥18~     years of age receiving the vaccine and 798 healthy adults receiving placebo. Subjects will be~     randomized in a 3:1 ratio to receive either aH5N1c vaccine or saline placebo. Enrollment will~     be stratified by age: 18 to <65 years of age and ≥65 years of age, to allow adequate safety~     assessment of the entire age spectrum.~   "
55593|NCT02839317|"~     The cause of CD could be different according to age at onset of CD symptoms. Indeed we know~     that some very young patients at CD diagnosis have particular genetic variants as~     abnormalities of the IL10R that are regarded as quite monogenic disease. In the other way,~     the microbiota also undergoes substantial changes at the extremes of life, in infants and~     older people and the ramifications of which are very few being explored. The comparison of~     microbiota by principal component analysis and genetic profile of patients with CD beginning~     at the extremes of life could help us to better known physiopathology of CD according to age~     and provide arguments that CD beginning at the extremes of life could be different diseases.~      The aim of the study is to ascertain through population-based study the hypothesis that gut~     microbiota is different between paediatric-onset and elderly-onset CD patients in relation~     with genetic and environmental mechanisms. The results will provide a better knowledge of the~     etiopathogenic ways in CD and propose a personalized therapeutic care based on age at CD~     onset (i.e. according to the gut bacteria involved).~   "
55594|NCT02839304|"~     The objective of the study is to demonstrate the safety and feasibility of the Adagio~     Cryoablation System is subjects with Paroxysmal (PAF), Persistent (PsAF) and Long-Standing~     Persistent Atrial Fibrillation.~   "
55595|NCT02839291|"~     To evaluate the current medical practice and its influence on health-related quality of life,~     in patients who are treated with injectable bone antiresorptive drugs (biphosphonates or~     denosumab) for at least one year.~   "
55596|NCT02839278|"~     The aim of the study is to investigate in vitro the impact of a novel anti-inflammatory~     treatment on costimulatory molecules expressed on monocytes.~   "
55597|NCT02839265|"~     Based on promising data from our laboratory demonstrating synergy between ablative local~     radiotherapy and FLT3 ligand immunotherapy in murine NSCLC models, investigators are~     performing a phase II study combining FLT3L immunotherapy and SBRT for patients with advanced~     NSCLC that has progressed following standard systemic therapy. All patients will receive~     daily subcutaneous injections of CDX-301 (75 µg/kg) for 5 days, beginning on the first day of~     SBRT. SBRT will be delivered to a single pulmonary lesion. Depending on the size and location~     of the target lesion, the SBRT regimen will be 34 Gy x 1 (peripheral tumors smaller than 2 cm~     and not adjacent to the chest wall), 18 Gy x 3 (peripheral tumors not eligible for 34 Gy x~     1), or 10 Gy x 5 (central tumors). The primary endpoint will be progression-free survival at~     4 months, defined using immune-related response criteria (irRC). A total of 29 patients will~     be enrolled.~   "
55598|NCT02839252|"~     The specific aims of this pilot study are to:~        1. Evaluate the effectiveness of the asthma education intervention on asthma knowledge~        2. Determine whether the asthma education intervention improves child and parent asthma~          treatment self-efficacy~      Our hypothesis is that the asthma education intervention will significantly improve asthma~     knowledge and asthma self-efficacy at 1 month post-intervention as compared to controls.~   "
55599|NCT02839239|"~     The objective of this study is to determine an efficacy of the combination of L. rhamnosus~     19070-2 (FloraActiveTM) and L. reuteri DSM 122460 (FloraActiveTM) in decreasing cry/fuss in~     infants aged 4 through 12 weeks with IC. The active group of infants will receive~     lactobacilli with vitamin D3 while the control group will receive vitamin D3 2 times daily as~     oil suspension for 28 days. Duration of infant fuss/cry will be measured at baseline and at~     the end of intervention to define a difference between the groups~   "
55622|NCT02838940|"~     Background~      Preventive antibiotic treatment before performing invasive procedures is a basic element in~     preventing infections. The essence of preventive antibiotic treatment is strengthening the~     defense mechanisms of the immune system by preserving a certain drug levels in the blood. The~     timing of giving the antibiotics is very important. Several research groups have tried to~     check the levels of Cefazolin (the most common antibiotics in the field of obstetrics) in~     serum and adipose tissue in women during cesarean. These groups presented conflicting~     research results.~      OBJECTIVE~      This study will discuss the preventive antibiotic treatment levels accepted prior cesareans,~     to determine:~        1. What are the factors affecting the level of drug in the blood?~        2. Is there a fixed time which beyond it, blood drug levels are below the MIC(Minimal~          Inhibitory Concentration)?~        3. Is the provision of usual preventive care also addresses the situations of metabolic~          disorder?~   "
55600|NCT02839226|"~     This prospective, placebo-controlled, double blind, randomized study is designed to assess~     the healing effects of AR/101 on chronic Hard-to-Heal wound(s) of different etiologies~     including arterial ulcers, diabetic ulcers and venous ulcers, of at least 3 months duration.~     After collection of comprehensive medical data to confirm eligibility of patient and~     obtaining informed consent , patients will enter Screening run-in Period where all wounds~     will be cleaned if necessary by surgical debridement and irrigation (isotonic solution) prior~     to initiation (run-in phase) of the study according to physician's instructions. During the~     14 day screening period, all subjects will receive standard of care (SoC) on a daily basis,~     as per indication and patients status, according to physicians instructions. Wounds will be~     morphologically assessed by the treating physician and by photographic evaluation by the PI~     once a week - at days 7 and 14 of the screening run-in phase. Following the run-in period,~     Subjects with wounds of ≥ 5cm2 and ≤100 cm2 of at least 3 months duration that fail to~     respond to treatment with SoC during the screening run-in phase will be enrolled into the~     study. Eligible subjects with wounds will be randomized and treated topically with AR/101+~     SoC or placebo +SoC once daily for up to 14 days. During this treatment phase I, depending on~     their wound size and wound type, subjects will receive treatment dose applied topically daily~     and wounds will be dressed according to physician's instructions. Wounds will be photographed~     daily and assessed by the treating physician in the clinic once a week (at the end of each~     weekly period). During the treatment period, adverse events and concomitant medications will~     be monitored; wounds will be morphologically assessed by photo documentation and followed for~     wound bed progression and granulation tissue formation. At the end of Treatment period I,~     patient's wounds will be analyzed and all patients from both treatment arms with wound score~     0-2 will be assigned to receive the study drug for and additional up to 14 days treatment~     phase II in full accordance with the treatment regimen described in Treatment phase I. A~     termination visit will be performed at day 14 of Treatment phase I or II or earlier if the~     wound has reached the maximum score on the granulation scale or if the wound is ready for~     skin grafting; or in any case of early withdrawal that is not due to withdrawal of consent.~   "
55601|NCT02839213|"~     The management of normal labor is both an art and a science. For decades, health providers~     have worked to manage labor actively and safely, with the goal of shortening the duration of~     painful labor. Reduction of Cesarean sections and other fetal and maternal complications is~     also an important aspect of labor management.~      The safety of active management of labor has been demonstrated by several prospective~     randomized clinical trials. A shorter duration of labor from admission to delivery has also~     been consistently reported in numerous studies of women treated with the active management~     protocol.Hyoscine butylbromide belongs to the parasympatholytic group of drugs and is a~     semisynthetic derivative of scopolamine. It is an effective antispasmodic drug without the~     untoward side effects of atropine. Hyoscine butylbromide is a quaternary ammonium compound~     and has peripheral anticholinergic action, but no central action as it does not cross the~     blood-brain barrier. Hyoscine butylbromide acts primarily by blocking the transmission of~     neural impulses in the intraneural parasympathetic ganglia of abdominal organs, apparently~     inhibiting cholinergic transmission in the synapses of the abdominal and pelvic~     parasympathetic ganglia, thus relieving spasms in the smooth muscles of gastrointestinal,~     biliary, urinary tract, and female genital organs, especially the cervico-uterine plexus,~     thus aiding cervical dilatation.~      Spasmolytic drugs are frequently employed in delivery rooms to overcome cervical spasms and~     thus reduce the duration of labor.~      Hyoscine butyl bromide has been used to shorten the duration of labor in several hospitals in~     the world. The mechanism by which it acts in the context of labor has not yet been~     elucidated, and evidence of its efficacy has been largely anecdotal.~      Major studies have been carried out to evaluate the effects of the injectable or suppository~     form of Hyoscine butyl bromide on cervical dilatation; a majority of these studies~     demonstrated the efficacy of Hyoscine butyl bromide in augmenting labor. However, a few~     studies showed no effect of Hyoscine Butyl bromide on accelerating labor. In addition, some~     studies also used oxytocin in active management of labor, which would certainly affect the~     duration of labor and increase bias in the results. The specific objectives of this study~     will be to assess whether Hyoscine butyl bromide is effective in hastening cervical~     effacement and dilatation, thus shortening the duration of the first and second stages of~     labor with or without labor augmentation. We also intended to determine whether the use of~     Hyoscine butyl bromide in the first and second stages of labor has any associated increases~     in complications, such as an increase in blood loss or the rate of cesarean deliveries.~   "
55602|NCT02839200|"~     The primary objective of this study is to assess the effect of ACT-541468 on a measure of~     sleep maintenance (Wake after Sleep Onset or WASO) by polysomnography in subjects with~     insomnia disorder.~   "
55603|NCT02839187|"~     The present study aimed at measuring cerebral changes in Alzheimer Disease (AD) patients, who~     responded to strict physiological criteria typical of AD pathology. The objective of the~     present study was to identify the earliest alterations in cerebral connections that could~     contribute to the initial episodic memory impairment.~   "
55604|NCT02839174|"~     The investigators have identified a support group on social media with ~1500 members~     (children and adults), the majority of whom have T1DM and follow a carbohydrate-restricted~     diet. Many participants report exceptionally low HbA1C and insulin requirements. If these~     anecdotal reports are reflective of a large group of people with type 1 diabetes, a clinical~     trial would be warranted.~      The investigators propose to survey the above-mentioned group and their professional diabetes~     care providers to characterize glycemic control and explore associated dietary and diabetes~     care factors.~   "
55605|NCT02839161|"~     Double blind, randomized, controlled, dose-escalation Phase 1 clinical trial in~     hookworm-exposed children aged 6 to 10 years living in the area of Lambaréné, Gabon. Children~     will receive three doses of the Na-GST-1/Alhydrogel hookworm vaccine co-administered with the~     Na-APR-1 (M74)/Alhydrogel hookworm vaccine or the hepatitis B vaccine co-administered with~     sterile saline. All injections will be delivered intramuscularly (deltoid) on approximately~     Days 0, 56, and 112 or 180.~   "
55606|NCT02839148|"~     This study will provide a tool for researchers to measure important outcomes in relation to~     trial of intervention to reduce or prevent stunting.~      Hypothesis: We assume that appetite score will be associated with improvement in growth and~     development parameters of children given the nutrition and psychosocial stimulation~     intervention~      Objectives:~      To explore maternal perception regarding childhood stunting To develop and validate an~     appetite measuring tool To assess the appetite status of young children To examine the~     relationship between appetite score, growth and development, potential biomarkers of~     appetite, child food intake and intestinal inflammation of the children.~      Methods: In the first phase, a qualitative study will be conducted to explore maternal~     perception regarding childhood stunting and to develop a tool- the Early Childhood Appetite~     and Satiety Tool(ECAST) using mixed method approach (qualitative and quantitative). In the~     second phase, a community-based trial will be conducted with 50 stunted children of aged~     12-18 months, living in urban slums of Dhaka, and 50 age-sex matched control children~     (non-stunted).~   "
55607|NCT02839135|"~     In this comparative bioavailability and in vivo skin adhesion study, the impact of minor~     changes in qualitative composition of polyiso-Butylenes (PIB) from a different supplier and~     change of the manufacturing line of the micro porous membrane will be tested.~   "
55608|NCT02839122|"~     This is open-Label, A Randomized, Crossover study to evaluate the safety and pharmacokinetic~     interaction after oral concomitant administration of Dutasteride and Tadalafil in healthy~     male volunteers.~   "
55623|NCT02838927|"~     Very few data has been published on the epidemiology of hypoparathyroidism worldwide: none~     exists specifically for France. Hypoparathyroidism could led to complications. Here, the~     investigators plan to collect data about both epidemiology, medication and complication of~     hypoparathyroidism in France.~   "
55624|NCT02838914|"~     The purpose of the study is to assess the reconstruction and inverse reconstruction in right~     atrium by speckle tracking echocardiography combined with real-time three dimensional~     echocardiography for atrial fibrillation patients before and after radiofrequency ablation~     (RFCA)~   "
57292|NCT02817087|"~     Transcranial magnetic stimulation for post-stroke upper-body motor deficits.~   "
55609|NCT02839109|"~     In patients with esophageal cancer (EC) neo-adjuvant chemoradiation (nCRT) followed by~     surgery with curative intent leads to objective responses in 45 to 60%, whereas 20-35% of the~     patients had no residual tumor (ypT0N0) at pathologic examination. The absolute survival~     benefit of response to nCRT is 15%, but still 14% of the patients develop locoregional~     failure in the CROSS trial. 18F-fluorodeoxyglucose positron emission tomography with computed~     tomography ((FDG-PET-CT) is able to distinct responders from non-responders, but still misses~     significant clinical evidence. Whole-body diffusion-weighted imaging (DWI) magnetic resonance~     imaging (MRI) has shown potential benefits, which might be enhanced by combining both~     methods. PET/CT and DWI-MRI more precisely correlate anatomic and metabolic FDG-avid lesions~     and seem to assess post-treatment changes, especially regarding nodal staging. Both~     techniques claim an important role in selection of patients with clinical complete response~     (cCR) and indirectly with pathologic complete response (pCR) after nCRT. However, the exact~     role and complementary effects of both techniques is still unknown.~      For appropriate judgment of response, secure standard endoscopic ultrasonography (EUS) with~     fine needle aspiration (FNA) / biopsy of potential suspected lesions, both nodal or residual~     tumor, seen on PET/CT or DWI/MRI or during EUS will be performed <2 weeks before surgery,~     approximately 6-10 weeks after nCRT and compared with the situation at primary staging.~     Patients with clinical complete response (cCR) resembling pathologic response (pCR= ypT0N0)~     after nCRT may refrain from surgical resection and related morbidity and mortality. However,~     patients without early (2wk after commencement) response during nCRT course may not benefit~     from nCRT.~      DWI-MRI seems effective in pre-treatment prediction of treatment outcome. Apparent diffusion~     coefficient (ADC), which indirectly measures tissue density, can be used to determine the~     likelihood of tumor response to treatment. High ADC before treatment has shown to predict an~     unfavorable response. Tumors with low ADC values on presentation generally respond better to~     treatment. An increased ADC in patients during and after nCRT could be used to predict early~     pathologic response i.e. discrimination of responders and non-responders to nCRT.~   "
55610|NCT02839096|"~     The investigators will randomize women diagnosed with anemia in the mid-trimester of~     pregnancy to once or twice daily iron supplementation~   "
55611|NCT02839083|"~     Breast surgeries are usually associated with significant postoperative pain. Suitability of~     analgesic technique after breast surgery is always questionable. The aim of this study is to~     compare US guided Pecs II block versus thoracic paravertebral block performed by US guidance~     as regards to potential complications and analgesic efficacy of both techniques in the first~     24 h after modified radical mastectomy.~   "
55612|NCT02839070|"~     The study is a combination of outpatient and inpatient monitoring. During the 27-day~     inpatient portion of the study, the individual's sleep-wake schedule will be varied daily.~     Volunteers will be randomized to a regular or irregular inpatient schedule.~   "
55613|NCT02839057|"~     Fractures of the second cervical vertebra (C2) are the most common spinal fracture among the~     elderly. Non-surgical treatment comprises of cervical collar treatment for 12 weeks, while~     surgical treatment for elderly could mean posterior fixation C1-C2 without collar treatment~     or anterior screw osteosynthesis C2 with 6 weeks of collar treatment. A meta-analysis of~     retrospective studies has recently found an improved survival with surgical treatment. This~     national registry study is designed to estimate the survival of non-surgical and surgical~     treatment in a population-based cohort.~   "
55614|NCT02839044|"~     Arterial calcification is an independent predictor of coronary events associated with a 3-4~     fold increased risk of cardiovascular events. Currently, no effective intervention exists to~     reduce arterial calcification. However, recent studies showed that vitamin K may reduce~     ongoing calcium deposition in the arteries, and thereby inhibit arterial calcification.~      The primary objective is to determine if MK-7 supplementation leads to stabilization or~     attenuation of ongoing calcium deposition in the femoral artery as quantified by 18F-NaF~     PET/CT imaging in patients with type 2 diabetes and arterial disease.~   "
55615|NCT02839031|"~     Diabetes mellitus in children and adolescents is a source of stress and poor quality of life~     for themselves and their family. Development of adaptive coping strategies may be improved by~     focused parent and children training. This study assesses a cognitive behavioral treatment~     (CBT) for children/adolescents with diabetes and their parents in comparison with standard~     health educational interventions. The investigators main aim is to verify that the CBT~     program improves overall balance of glycaemia better than phone contact without CBT content~     (control group). Secondary objectives are expected improvements of health-related quality of~     life and coping styles in parents and children.~   "
55616|NCT02839018|"~     Little is known about nutritional Parameters that potentially influence the course of~     intensive-care unit acquired weakness (ICU - AW). The investigators aim to elucidate the~     nutritional profiles in blood, urine and muscle in respective patients at risk.~   "
55617|NCT02839005|"~     Context: Cesarean section is the most common surgery in women, both in developed and~     underdeveloped countries. However results are conflicting report in which material for~     intradermal suturing get better aesthetic result. Objective: To compare the aesthetic~     appearance of two suture materials, polyglecaprone 25 and polyamide (nylon) with intradermal~     sutures for skin closure in women undergoing cesarean section first. Methods: This is a~     clinical, prospective and randomized study which was conducted in the Department of~     Gynecology and Obstetrics of a tertiary Institute, Hospital das Clinicas Samuel Libânio, in~     PousoAlegre, Estate of Minas Gerais. Sixty women undergoing cesarean section were first~     included and randomized into two groups: group I (n = 30) polyamide and group II (n = 30)~     polyglecaprone 25. Hypertrophy, color and width of the wound were evaluated, receiving a~     score, according to Trimbos table, six months after surgery. Later the results were compared~     to non-parametric statistical tests~   "
55618|NCT02838992|"~     To assess whether ATG Combined With Cyclophosphamide and cord blood infusion can accelerate~     hematopoietic reconstruction in severe aplastic anemia patients and improve clinical curative~     effect and safety~   "
55619|NCT02838979|"~     The primary goal of proposed investigation is to study the impact of oral glutamine~     supplementation on muscle mitochondrial and endothelial cell function measured mitochondrial~     energetics and vascular function using 31P magnetic resonance spectroscopy and optical~     spectroscopy (MRS/OS) among persons with moderate-severe CKD. The secondary objective is to~     describe the impact of oral glutamine supplementation on mitochondrial metabolic profile as~     well as inflammatory and oxidative stress biomarkers among persons with chronic kidney~     disease.~   "
55620|NCT02838966|"~     The purpose of this study is to determine the optimal effective dose for preoperative~     nutritional supplementation with immunomodulators on immune function and perioperative~     outcomes following pancreaticoduodenectomy for pancreatic adenocarcinoma.~   "
55621|NCT02838953|"~     To determine whether the COPD impairs the diaphragmatic mobility (DM), and verify~     improvements after an inpatient pulmonary rehabilitation (PR).~      Ultrasonography on M-mode will assess the diaphragmatic mobility at rest breathing and at~     slow deep inspiration. Lung functions test, arterial blood gas analyses, six minute walk test~     will be also performed, on COPD patients and healthy subjects.~   "
55625|NCT02838901|"~     This is a double-blind, randomized, placebo-controlled, pilot study. Participants will be~     randomized to receive either beetroot juice or a beetroot juice placebo, as a dietary~     supplement, for 30 days. Beetroot juice is high in nitrates, a chemical when ingested is~     found to increase blood flow to the brain. The purpose of this research study is to determine~     the safety and feasibility of using this nutritional intervention in (ischemic)stroke~     survivors, and prove that plasma levels of nitrate and nitrite increase as expected.~     Secondary outcomes includes measuring a comprehensive set of outcomes related to functional~     status post-stroke, including mobility, upper extremity strength, cognition, depression, and~     disability. Patients will also be randomized to MRI perfusion scanning in the region of the~     stroke to measure cerebral blood flow.~   "
55626|NCT02838888|"~     Screening colonoscopy is considered the gold standard for adenoma detection in the colon.~     However, it has been shown that a considerable number of polyps can be missed during~     screening colonoscopy. Until now the endoscopist himself is responsible for the detection of~     adenomatous polyps. No automatic tools are available supporting the colonoscopist to detect~     lesions. Recently, a computer program was developed that can be used to recognize and extract~     suspicious structure from colonoscopy video sequences. The program was built to automatically~     detected colonic polyps and to highlight the polyps by colour marking. The program was now~     refined so that the respective structures can be highlighted during real time colonoscopy.~     The aim of this feasibility study is to test whether the software is applicable during real~     time colonoscopy.~   "
55627|NCT02838875|"~     Background Neonatal hypoglycemia is one of the most common metabolic disorders in~     neonatology. Maintaining stable levels of glucose in the transition from fetal life to life~     after birth is very important. Yet, except for the recognizing of at-risk populations, there~     are not many individual measures which can help and predict which newborns (from at-risk~     populations) will develop hypoglycemia and which will not.~      OBJECTIVE our objective is to try to characterize by the mother's glucose levels at birth and~     by umbilical cord glucose levels who would be at increased risk of hypoglycemia in the hours~     after birth in the population that is at increased risk of this complication in advance.~   "
55628|NCT02838862|"~     Although gastroenteropancreatic neuroendocrine neoplasia (GEP-NEN) were considered for years~     as rare tumors, their incidences are increasing. Due to their potential of early metastases~     and their heterogenous response to therapy, these tumors are important clinical entities. A~     major problem remains the impossibility to adequately predict tumors' response to treatment,~     precluding an individualized therapy. Further, there is no method to efficiently screen these~     tumors. Protein based analyses (proteomic analyses) gain in interest as methods to address~     this problematic.~      The present study was designed to investigate epidemiologic data of patients with GEP-NEN and~     to answer following questions using proteomic analysis applied to existing pathology~     specimens (paraffin-embedded specimens, FFPE): is it possible to explore protein signatures~     in this type of tumors? Is the response to therapy predictable using specific protein~     signatures? Is the tumor's tendency to metastasize related to specific protein signatures?~   "
55629|NCT02838849|"~     Twenty healthy volunteers had their baseline parameters (symptoms, bowel habit, quality of~     life, fecal characteristics and microbiota) measured during a week of monitoring followed by~     randomization to a 14 days course of increased fiber in diet or increased fiber and water~     intake, with repetition of parameters measuring at the end.~   "
55630|NCT02838836|"~     Patients with resectable solid primary cancers and even limited number of metastases are~     potentially curable. However, most patients develop recurrences despite surgery. Circulating~     and disseminated tumor cell (CTC/DTC) and circulating cell-free (cf) DNA isolation from the~     blood, urine and bone marrow will increase understanding of cancer spread and advance~     knowledge to develop individualized therapies.~   "
55631|NCT02838823|"~     This is a mono-center, open-label, phase 1 study evaluating the humanized anti-PD-1 antibody~     JS001, as a monotherapy in patients with triple negative breast cancer who have failed in~     routine systemic treatment. The study will be conducted in 2 parts: dose escalation and~     cohort expansion to investigate tolerability and efficacy.~   "
55632|NCT02838810|"~     As HBsAg clearance is uncommon in chronic hepatitis B (CHB) patients on nucleoside analogues~     (NAs) therapy. The purpose of this study is to optimize HBsAg clearance in CHB Patients with~     sequential treatment of pegylated interferon alpha and NAs.~   "
55633|NCT02838797|"~     This is a study to determine the safety and tolerability of a new medicine (RQ10) for~     gastrointestinal symptoms in Parkinson's disease. The investigators will also begin to look~     at the effect of this medicine on gastrointestinal problems. The results will determine if~     future studies are appropriate. In this study, RQ10 will be compared to a placebo (a~     look-alike inactive substance). Participation will include multiple office visits.~     Approximately 48 people will participate.~   "
55634|NCT02838784|"~     This study will compare the proportion of patients who have wound closure within 12 weeks as~     well as the time to wound closure in patients receiving Artacent™ versus standard of care for~     treatment of non-healing lower extremity wounds. The recurrence of healed wounds will be~     assessed at 6 months via a telephone survey~   "
55635|NCT02838771|"~     The aim of this research was to develop a dysphagia screening measure and evaluate the~     prevalence of dysphagia and its clinical manifestation in different in age population groups.~   "
55636|NCT02838758|"~     The purpose of this study is to evaluate the effectiveness of a device that delivers freezing~     temperature compared to injecting lidocaine (an anesthetic medication) in providing pain~     relief to patients with disorganized nerve bundle between the toes, also known as Morton's~     neuroma. The same ultrasound technology that the obstetricians use to visualize a fetus~     inside a pregnant woman will be used to help the study physician to locate the Morton's~     neuroma while precisely delivering the freezing temperature and lidocaine near the nerve.~   "
55649|NCT02838589|"~     This randomized controlled trial investigates the effect of a single dose of glucagon-like~     peptide-1 (GLP-1) receptor agonist on cerebral blood flow velocity and cortical oxygination~     in humans without cerebrovascular disease. This study serves as a control for a similar study~     investigating the effect in stroke patients (ref. to EGRABIS1).~   "
55737|NCT02837445|"~     The purpose of this double blind randomized study is the evaluation of the safety and~     efficacy of the Moderato System. The Moderato pacemaker is indicated for patients who require~     a dual chamber pacemaker and also have hypertension, in order to reduce their blood pressure.~   "
55637|NCT02838745|"~     Primary Objective~      To determine the maximum tolerated dose (MTD) of intrathoracic administration of pemetrexed~     when given in conjunction with cisplatin in patients with resectable malignant pleural~     mesothelioma MPM.~      Secondary Objectives~      To determine the toxicity and grades associated with cytoreductive surgery and Hyperthermic~     Intraoperative Chemotherapy HIOC with cisplatin and pemetrexed in patients with resectable~     MPM.~      To assess overall survival and progression-free survival after PD or EPP and HIOC with~     cisplatin and pemetrexed for MPM~      Correlative Objectives~      To characterize the pharmacokinetics and pharmacodynamics of pemetrexed when administered as~     a hyperthermic intrathoracic lavage after PD or EPP~      To determine whether the degree of thymidylate synthase and ERCC1 gene expression in MPM~     tissue correlates with clinical response to pemetrexed.~   "
55638|NCT02838732|"~     In this project, the investigators aim to investigate if daily carnitine supplementation~     could induce TMAO productivity of vegetarian gut microbiota and through which the TMAO~     producers might be disclosed.~   "
55639|NCT02838719|"~     Transverse abdominis plane (TAP) block is a regional anaesthesia technique that provides~     analgesia to the parietal peritoneum as well as skin and muscles of the anterior abdominal~     wall. In the past, a number of adjuvants have been added to the local anaesthetics in~     peripheral and neuraxial blocks resulting in an effective and long lasting analgesia.In~     recent times, dexamethasone has been increasingly used as an adjuvant to local anaesthetics~     in peripheral nerve blocks. Dexamethasone has a long and efficient glucocorticoid structure~     and also has anti-inflammatory property. It also blocks the C- fibers of pain pathway. When~     added to local anaesthetics as an adjuvant in peripheral nerve blocks, it has shown to~     prolong the analgesia time. A number of previous studies have also shown an opioid sparing~     effect of steroids, when used intravenously perioperatively. Though previous studies have~     shown that addition of dexamethasone to local anaesthetics in transverse abdominis plane~     block prolongs the duration of block, however it is not known whether this effect of~     dexamethasone is due to its peripheral action or because of its systemic absorption. Thus, in~     this study planned to compare the effectiveness of dexamethasone on quality and duration of~     analgesia when used as an adjuvant with local anaesthetics in transverse abdominis plane~     block versus when given systemically by intravenous route along with transverse abdominis~     plane block using local anaesthetics only, in patients undergoing gynaecological laparoscopic~     procedures under general anaesthesia.~   "
55640|NCT02838706|"~     The overall aim of the study is to investigate the time difference in the diagnosing of~     anemia among elderly with hip fracture, between measurements with standard blood samples and~     non-invasive SpHb-measuring. Another aim is to investigate the relationship between perfusion~     index and prolong perioperative anemia and the potential impact on perioperative~     complications.~   "
55641|NCT02838693|"~     The Bio-bank and Registry for StratIfication and Targeted intErventions in the Spectrum Of~     Type 2 Diabetes (BRITE-SPOT) has been set up to prospectively collect clinical data and~     biologically relevant samples from individuals with, and at risk for type 2 diabetes (T2D),~     with the aim of delineating factors related to susceptibility, progression, complications and~     response to treatment. Expanded from BRITE-SPOT, Assessing the Progression to Type - 2~     Diabetes (APT-2D) is a prospective cohort with a focus on non-diabetics (normoglycemic or~     prediabetic), to expand the sample size and depth of metabolic phenotyping in these upstream~     groups, with the more targeted aim of delineating factors related to insulin sensitivity~     versus secretion, that relate to progression to T2D.~   "
55642|NCT02838680|"~     To evaluate the safety and performance of the HLT System in patients with severe aortic~     stenosis who present at high risk for aortic valve replacement surgery.~   "
55643|NCT02838667|"~     Nephrology participation in care of patients undergoing CABG could reduce AKI through~     correction of modifiable risk factors and early detection and intervention of post-op AKI.~   "
55644|NCT02838654|"~     The purpose of this study is to analyze the reliability of epidural wave form during~     cerivical epidural injection.~   "
55645|NCT02838641|"~     This is an observational study using Bronchial-alveolar lavage (BAL) as specimen for~     GeneXpert, a real time polymerase chain reaction (PCR) test for detection of tuberculosis~     (TB). Patients suspicious of TB, who require bronchoscopy as part of the investigation~     procedures, will be recruited for this study over a period of 18 months. Clinical likelihood~     of TB will be systematically scored according to various clinical parameters. This will~     determine the pre-test probability. Clinician will decide if anti-TB treatment is to be~     started and patients will be followed up for a minimal of 18 months. Sensitivity,~     specificity, positive, negative predictive values and the respective likelihood ratio will be~     calculated accordingly.~   "
55646|NCT02838628|"~     In this study, the activity, safety, and pharmacokinetics (PK) of KX2-391 Ointment will be~     evaluated in adult subjects with a clinical diagnosis of stable, clinically typical actinic~     keratosis (AK) on the face or scalp.~   "
55647|NCT02838615|"~     The purpose of this study is to compare the clinical efficacy, incidence of ventral epidural~     spreading and provocation of concordant paresthesia, amount of radiation exposure and total~     procedure time between transforaminal and parasagittal interlaminar epidural injection.~   "
55648|NCT02838602|"~     This is a transnational prospective randomized trial comparing definitive carbon ion therapy~     versus photon or combined photon and protontherapy as standard treatment for unresectable or~     macroscopically uncompleted resected radioresistant tumors. Eligible tumors are axial~     chordoma (except of base of skull), adenoid cystic carcinoma of head and neck (except of~     trachea) and sarcomas of any site (except chondrosarcoma of the skull base), non previously~     irradiated and without pre-planned surgery or chemotherapy after the clinical trial~     procedure. Randomization is balanced 1 for 1. Patients of the experimental arm are treated in~     carbon ions centers in Europe and patients of the standard arm are treated in France in their~     closest participating radiotherapy center. An accrual of 250 patients is needed and an~     absolute difference of 20% of relapse free survival at five years is awaited. The main~     endpoint is the progression free survival at five years. The trial is supported by the French~     program of clinical research and the national health insurance. Two associated studies are~     carried out: a radiobiological one looking for radioresistance markers in the sarcomas~     biopsies, and the second one is about medico economics.~   "
60444|NCT02775695|"~     This is a window-of-opportunity study that examines the efficacy of doxycycline, and~     FDA-approved oral antibiotic, on metakaryotic (cancer stem cells) in resectable pancreatic~     cancer following eight weeks of treatment.~   "
55650|NCT02838576|"~     Arthralgia has been a common complaint in postmenopausal period which seems to be involved~     with estrogen depletion, although, its pathophysiology isn´t completely clarified. It seems~     to relate with the level of physical activity, climacteric symptoms and pain catastrophizing.~     In view of the multiple dimensions involved in arthralgia in postmenopausal women which~     characterize it as a complex phenomenon, this study aims to describe the effects of hormone~     replacement therapy in women aged between 45 and 55 years, considering estrogen as a possible~     anti-nociceptive factor.~   "
55651|NCT02838563|"~     Current scales are not suited to a direct measure for the elderly with cognitive disorders~     and are difficult to handle for the care teams. In this context, a visual analog scale was~     created to answer a single question How are you feeling now, immediately? with the help of~     pictograms. This study aims to assess the validity and reliability of the Scale of Well-Being~     Assessment (SIWA) (in french : Echelle d'Evaluation Instantanée du Bien-Etre (EVIBE)) in~     people with Alzheimer's disease or a related disease.~   "
55652|NCT02838550|"~     The aim of this study is to analyze the effect of a motivational online intervention (MOI)~     using pedometers to increase physical activity in a sample of sedentary students. It will be~     compared three conditions: MOI+PEDOMETER condition (access to a MOI and the use of a~     pedometer of new generation); MOI condition (access to a MOI and the use of a blinded~     pedometer); and CONTROL condition (the use of a blinded pedometer).~   "
55653|NCT02838537|"~     This study will be conducted as a retrospective study of exposed and unexposed cohort of the~     French population included all beneficiaries aged 65 and older. Exposed patients will be~     matched to non exposed controls according age, gender and area of residence (ratio 1/4). Two~     exposed arms and two non exposed control arms will be planned. Triptan arm will be user of~     triptan defined as at least one recorded dispensing of any drug during the follow up, with no~     recorded of any of these drugs during the previous 6 months (new or incident users). Ergot~     arm will be user of ergot derivative defined as at least one recorded dispensing of any drug~     during the follow up, with no recorded of any of these drugs during the previous 6 months~     (new or incident users). This study involved data from the French National Health Insurance~     Information System (Système National d‟Information Inter-Régimes de l‟Assurance Maladie ;~     SNIIRAM) linked with the French hospital discharge database (Programme de Médicalisation des~     Systèmes d‟Informations, PMSI).~        -  The SNIIRAM is a vast national medico-administrative database representing the most part~          of the French population, allowing to identify and to describe precisely all medication~          dispensations (name of drug, date of dispensing and quantity) including triptans and~          other reimbursed medications.~        -  The PMSI provides medical information about all patients admitted to hospital in France,~          including discharge diagnoses encoded according ICD-10, medical procedures and French~          diagnosis-related groups The research proposed is expected to provide an update and~          nationally-consolidated estimation of the cardiovascular risk is associated to triptans~          use in elderly population.~   "
55654|NCT02838524|"~     Partially assisted mechanical ventilation is ideally titrated to maintain adequate~     inspiratory muscle activity (i.e. preventing disuse atrophy) while avoiding excessive (i.e.~     fatiguing) inspiratory loads. The advent of ventilator modes enabling flow and pressure~     assistance in proportion to patient inspiratory effort (i.e. Proportional Assist Ventilation~     (PAV), Neurally-Adjusted Ventilator Assist (NAVA)) permit careful titration of ventilatory~     support to achieve desired levels of patient inspiratory effort. However, data on the~     acceptable range of values for inspiratory effort and respiratory muscle load-capacity~     balance during mechanical ventilation are currently very limited. Such data are critical to~     inform a physiologically sound evidence-based approach to titrating partially-assisted~     ventilatory support. This study is designed to ascertain a physiologically acceptable range~     of inspiratory effort in mechanically ventilated patients. The study protocol includes~     measurements of the respiratory system during spontaneous breathing as well as evaluating the~     diaphragm in real-time with the use of ultrasonography. The experimental design outlined in~     the present study is predicated on the assumption that the range of values for inspiratory~     effort and load-capacity balance observed in patients who are successfully weaned from~     mechanical ventilation represent the safe and appropriate range of target values.~   "
55655|NCT02838511|"~     Though most physicians believe they can identify frail patients, frailty is a poorly~     characterized and complex clinical syndrome. Frailty has been categorized four dimensions by~     de Vries et al: 1) physical (physical activity, nutrition, mobility, strength and energy); 2)~     biochemical (nutritional and inflammatory biomarkers); 3) psychological (cognition and mood);~     and, 4) social (social contact and support). 1 However, the pathophysiology of frailty~     remains unclear. Two broad hypotheses have been proposed.~      Deficit accumulation model: This hypothesis assumes that frailty occurs due to accumulation~     and additive effect of multiple deficits, which occur across various domains. The more~     deficits a person has, the more likely that person is to be frail. Frailty in this paradigm~     is thus measured by identifying the number of positive factors/ deficits from a list. This is~     used to create a proportional index of deficits, expressed as the ratio of deficits present~     to the total number of deficits considered.~      Many studies have used a modified frailty index (MFI) with 11 factors, which has shown to~     correlate well with patient outcomes after surgery.~      Phenotype model: Fried et al in 2001 proposed a phenotype based model, in which she~     identified various clinical features that define frailty as a clinical syndrome. This~     criterion, known as Fried index, consists of 5 factors- shrinking, weakness, exhaustion,~     slowness, and low physical activity level. The Fried index is the most commonly used~     phenotype-based assessment tool to evaluate frailty. An advantage is its ease-of use during~     preoperative visits. Measurement of these factors in a perioperative setting was further~     characterized by Makary et al in 2010, and was the basis for the Hopkins Frailty Score (HFS).~      Currently, there exists no gold standard for assessment of frailty, especially in the~     perioperative setting. In the absence of a well-accepted gold standard, a measurement of~     frailty which would predict adverse postoperative outcomes would be useful. However, no study~     has compared the prognostic abilities of HFS and MFI, after non-cardiac surgery.~      All adult patients presenting to pre anesthesia evaluation clinic (PACE) at Cleveland Clinic~     main campus will be included in the this prospective observational cohort study. Frailty~     would be evaluated prospectively using HFS and components of MFI will be obtained from~     Cleveland Clinic Perioperative Health Documentation System registry (PHDS).~   "
55656|NCT02838498|"~     To test the benefits of ERCP Mechanical Simulator (EMS) practice in improving ERCP~     cannulation success rate of novice surgical trainees.~   "
55657|NCT02838485|"~     Goals : ( a) to examine differences in cortical activity during hand movements with a mirror~     compared to imagery of the same movements, and (b) to examine correlation between cortical~     activity during imagery or mirror treatment and the pain and performance measures in finger~     amputees.~      A cross-sectional study of 20 subjects in a Functional Magnetic Resonance Imaging (fMRI)~     preforming mirror therapy hand movement and imagery hand movement. Also, Visual Analogue~     Scale for pain and the Disability of the Arm, Shoulder and Hand (DASH) questionnaire and~     Jebsen Taylor Hand Function Test will be used.~   "
55658|NCT02838472|"~     Nicotinamide nucleotide transhydrogenase (NNT) mutations cause glucocorticoid and~     mineralocorticoid deficiencies through decreased detoxification of reactive oxygen species~     (ROS) in adrenocortical cells.~      Ascorbic acid is well known by its high antioxidant activity due to the neutralization of~     free radicals and other reactive oxygen species.~      Preliminary results of NNT_p.G200S homozygous fibroblasts' treatment with 10 micro molar~     L-ascorbic acid shows significant improvement in mitochondrial morphology and in ROS content.~      The aim of this study is to figure out if ascorbic acid treatment improves the phenotype of~     NNT patients by reducing ROS in their adrenocortical cells and preventing their apoptosis.~   "
55659|NCT02838459|"~     Using a prospective cohort design, the aim of this study is to compare the performance of~     clinicians with prediction models in triaging trauma patients.~   "
55660|NCT02838446|"~     The purpose of this study was to investigate of the effectiveness of Graded Motor Imagery~     (GMI) on hand functionality in patients with Distal Radius Fracture (DRFx). This study was~     carried out on 36 patients. These patients were randomly assigned to two groups: classic~     treatment group (n=19) and GMI group (n=17). Both groups received a 8-week (2 days a week)~     physical therapy and rehabilitation intervention. Outcome measurements were based on upper~     extremity functional status (Disability of the Arm Shoulder Hand and Michigan Hand~     Questionnaire scores), pain (on the rest and during the activity with Visual Analog Scale),~     range of motion (wrist flexion, extension, ulnar/radial deviation, supination and pronation~     with goniometer), grip strength (standard grip strength with Jamar hydraulic hand~     dynamometer; lateral, palmar and pinch strength with pinch meter).~   "
55661|NCT02838433|"~     The impressive clinical responses obtained with immune checkpoint inhibitors~     (anti-PD-1/PDL-1, anti-CTLA-4) indicate that the presence of preexisting antitumor immune~     response might be required for their efficacy and highlight the critical role of antitumor T~     cell immunity.~      Recent progresses on the field of tumor immunology underline the critical role of CD4 helper~     1 T lymphocyte (TH1) in the control of innate and adaptive anticancer immunity. Therefore,~     monitoring tumor specific TH1 response could be relevant in cancer patients.~      In order to monitor tumor-specific CD4 Th1 responses in most cancer patients, the~     investigators team have previously described novel promiscuous peptides (referred as UCP:~     Universal Cancer Peptides) derived from human telomerase (TERT), a prototype of shared tumor~     antigen.~      By using UCP-based immuno-assay, UCP specific Th1 immune responses will be evaluated in this~     study in melanoma before and after treatment.~   "
55662|NCT02838420|"~     This randomized, multicenter, Phase III, open-label study will evaluate the efficacy and~     safety of alectinib versus crizotinib and to evaluate the pharmacokinetics of alectinib in~     asian participants with treatment-naive ALK-positive advanced NSCLC. Participants will be~     randomized 2:1 into one of the two treatment groups to receive either alectinib (600~     milligrams [mg] twice daily [BID]) or crizotinib (250 mg BID) orally, respectively.~   "
55663|NCT02838407|"~     The purpose of this study is to identify and characterise bacteria present in the lower~     airways of children with suspected chronic LRTIs and for whom bronchoalveolar lavage (BAL) is~     indicated by the clinician.~   "
55664|NCT02838394|"~     Dry Needling (DN) is a skilled intervention that uses acupuncture filiform needles that are~     inserted into myofascial trigger points or other tissues underneath the skin. It is used to~     treat myofascial or neuromusculoskeletal pain and to improve movement impairments. Although~     more and more physical therapists add this treatment tool to their skill box, there is~     uncertainty about its working mechanism and its efficacy. The latter is partially due to the~     challenging task of finding and using a true control or sham treatment. The investigators~     will use blunted needles, which will not perforate the skin, as sham treatment.~      This study will assess if DN of a trigger point in the gluteal muscles increases pain~     pressure threshold in that muscle, in another muscle innervated by the same segment (L4/5)~     and in an area not supplied by the same segment (i.e. the ipsilateral posterior shoulder). In~     addition, this study will assess if functionality, as measured by the Oswestry Disability~     Index (ODI) and 15-point Global Rating of Change Scale (GRoC) questionnaires, improves after~     2-3 treatments (1 week) of DN.~   "
55665|NCT02838381|"~     The aim of this study is to characterize the genetic and cellular immunological parameters of~     metastatic digestive cancer patients having short and long responses to chemotherapy.~   "
55666|NCT02838368|"~     The incidence of type II glycogen-storage disease (Pompe disease) varies depending on~     ethnicity and geographic region. As of 2010, nine studies have been published documenting the~     incidence of Pompe disease. It is most common within the African American population, with an~     incidence of 1 in 14,000. In the U.S. more broadly speaking, the combined incidence of all~     three variants of the disease is 1 in 40,000. These estimates relied on the frequencies of~     three mutations in the gene acid alpha-glucosidase (GAA), leading to variants of the disease.~     Criteria for inclusion in the studies were often non-selective; in many cases, molecular~     genetic screening was done at birth. With such a high prevalence of Pompe disease reported,~     it is expected that large university medical centers specializing in neuromuscular diseases~     would see a higher incidence of Pompe disease among their patients. From a comparable Italian~     multicenter study, it appears that Pompe disease accounts for 3% of all patients presenting~     with proximal weakness with or without CK elevation.~      This study will measure the incidence of Pompe disease based on manifest laboratory~     abnormality, namely low GAA enzyme activity. Analysis of GAA enzyme activity will be~     determined through a blood sample of 4 mL. The study seeks to measure the epidemiology of~     Pompe disease by symptomatically screening all patients who present with symptoms of hitherto~     undiagnosed proximal weakness with or without elevation of the muscle enzyme, creatinine~     kinase (CK), or elevation of CK alone, at thirteen academic tertiary neuromuscular practices~     throughout the United States and Canada. Total recruitment is expected to be ~1,500~     participants. It is anticipated that the number of incident Pompe cases in this cohort would~     be between 3-5%, i.e. 45-75 newly diagnosed cases of Pompe disease.~   "
55704|NCT02837874|"~     Billroth-II (gastrojejunostomy) is one of major option after gastrectomy for gastric cancer.~     The investigators hypothesized that isoperistaltic anastomosis lead to higher incidence of~     dumping syndrome but antiperistaltic (anisoperistaltic) anastomosis have relevance to gastric~     stasis or obstruction. The investigators will assess complications, dumping syndrome and~     quality of life between isoperistaltic and antiperistaltic after distal gastrectomy for~     gastric cancer.~   "
55667|NCT02838355|"~     The purpose of this study is to explore how the End Tidal Carbon Dioxide monitoring via nasal~     cannula (ETCO2-NC) device may allow for earlier detection of respiratory complications. This~     device will detect the amount of carbon dioxide exhaled with each breath and may better~     predict high levels of this than traditional monitoring. This may reduce the number and~     severity of respiratory issues. A convenience sample of 60 participants either scheduled for~     continuous flow left ventricular assist device (CF-LVAD) implant or who have been readmitted~     to an ICU with a CF-LVAD will be recruited and randomized to usual care or usual care plus~     ETCO2-NC throughout their stay in the ICU.~   "
55668|NCT02838342|"~     This study will evaluate the potential immunomodulatory synergy of the association of~     metronomic cyclophosphamide (CMC) and interferon-alpha (IFN-alpha).~   "
55669|NCT02838329|"~     The purpose of this study is to determine weather using warmed (body temperature) 0.75%~     Ropivicaine to convert labour epidural analgesia to surgical anaesthesia, reduces the onset~     time of surgical block, compared to standard room temperature~   "
55670|NCT02838316|"~     The primary objective of this study is to evaluate the safety of Autologous Muscle Derived~     Cells for Gastro-Intestinal Repair (AMDC-GIR) during the 12 months following treatment of~     tongue dysphagia in male and female patients who have undergone surgery and/or chemo- and/or~     radiotherapy for squamous cell cancer of the oropharynx.~   "
55671|NCT02838303|"~     The purpose of this study is to evaluate self-reported symptoms as a proxy for acute~     organophosphate poisoning by examining self-reported acute organophosphate poisoning symptoms~     and PchE activity in response to occupational acute organophosphate exposure among farmers in~     Nepal.~   "
55672|NCT02838290|"~     Background: Over 39% of approximately 3,000 doctors (The British Medical Association~     quarterly survey, 2015) admitted to frequently feeling drained, exhausted, overloaded, tired,~     low and lacking energy. Such occupational distress may link to psychological and physical~     difficulties in doctors and have negative outcomes for organization and patients. The aim of~     the current study is to investigate the impact of an induction programme on occupational~     distress of doctors.~      Methods/design: Doctors will be invited to take part in an online research. Participants will~     be randomly assigned to the experimental and control groups. Participants in the experimental~     groups will complete one of the induction topics (about stress at work). Before and after an~     induction programme participants will be asked to fill in an online survey about their~     current occupational distress and organizational well-being.~      Discussion: The investigators expect that doctors' psychological, physiological and~     organizational well-being will improve after an induction programme which should serve as a~     resource for better doctor's own health understanding.~   "
55673|NCT02838277|"~     The INSIGHT study aims to phenotype individuals with subcutaneous adipose tissue (SAT)~     disorders specifically lipedema and Dercum's disease with an aim to find a cure for the SAT~     in these disorders that is resistant to diet and exercise.~   "
55674|NCT02838264|"~     The purpose of this study is to estimate the effect of itraconazole on the single dose~     pharmacokinetics of PF-06463922 in healthy volunteers in the fasted state.~   "
55675|NCT02838251|"~     About 15% to 30% of patients with venous leg ulcers have a peripheral arterial disease (PAD)~     associated. The compression band is still a controversial issue in this context. It allows~     the reduction of venous hypertension and edema, but it could potentially degrade the arterial~     infusion of high levels of compression. The French High Authority for Health (HAS) defines~     mixed ulcers by IPS between 0.5 and 0.9. Investigators distinguish mixed ulcers blood~     predominance for IPS between 0.5 and 0.7; and mixed ulcers predominantly venous blood with~     moderate involvement for IPS values between 0.7 and 0.9.~      Several studies have shown that IPS> 0.8 allowed a high compression, between 30 and 40 mmHg.~     In the case of mixed ulcers with IPS between 0.6 and 0.8, the HAS recommends using a lighter~     compression, bit by elastic bands (exercising low power compression at rest) under medical~     supervision, informing the patient to remove the bandage if pain or aggravation. It is~     therefore necessary to adapt the compression therapy in case of venous ulcers associated with~     arterial disease by providing a lower compression 30 mmHg short stretch. For HAS, IPS <0.6~     against indicates compression.~      A recent study showed that compression bit elastic bands could not only improve venous~     return, but it would also increase the distal arterial flow in a patient population with~     mixed ulcers. In this study, 25 patients had between IPS 0.5 and 0.8; or for certain patients~     below the threshold of 0.6 indicates that against a compression according to HAS. To our~     knowledge this is the only study that has examined the effect of compression on blood~     perfusion.~   "
55676|NCT02838238|"~     Our study is a prospective, randomized phase II clinical trial, to compare the efficacy and~     safety profiles of single X versus placebo as adjuvant chemotherapy regimens for elder breast~     cancer patients.~   "
55677|NCT02838225|"~     Our study is a prospective, non-inferior, randomized phase II clinical trial, to compare the~     efficacy and safety profiles of DA versus DAC as adjuvant chemotherapy regimens for~     early-stage breast cancer patients.~   "
55678|NCT02838212|"~     The purpose of this study is to determine the incidence of drug-related deaths in a~     university hospital during the year 2015~   "
55679|NCT02838199|"~     The purpose of this study is to determine that Transcatheter aortic valve replacement (TAVR)~     with SAPIEN 3 is superior to traditional surgical aortic valve replacement(SAVR) with~     bio-prosthesis regarding the rate of all-cause mortality at 1 year in patients with~     symptomatic severe aortic valve stenosis.~   "
55680|NCT02838186|"~     The aim of this study is to evaluate the examination of the proximal colon with the~     retroflexion colonoscopic technique in terms of feasibility and its possible additive~     contribution in the detection of important lesions, namely polyps and cancers.~   "
55681|NCT02838173|"~     This study compare the Serratus block plane (SPB) and the local infiltration of the tissue~     in the prevention of acute and chronic pain after breast cancer surgery.~   "
55728|NCT02837562|"~     The goal of the present study is to evaluate the prevalence of radiation-associated lens~     opacities among interventional cardiology staff members (such as physicians, technicians, and~     nurses) and determine its association with occupational history.~      The hypothesis of the study is that interventional cardiology staff will have high prevalence~     of radiation-induced lens opacities, which will be higher than non-interventional cardiology~     staff and will correlate with the estimated cumulative lifetime dose.~   "
55682|NCT02838160|"~     A randomized controlled triple blinded clinical trial with repeated measurements. The~     reporting of this study complies with the CONSORT (Consolidated Standards of Reporting~     Trials) statement for trials of non-pharmacological treatments.~      The first aim of the study was to evaluate the effectiveness of the three competing~     interventions on the critical care nurses' knowledge of, attitudes toward and adherence to 17~     ventilator bundle components; the second aim was to determine the effectiveness of adherence~     to 17 ventilator bundle components with pre-defined ventilator bundle on the psychological~     factors of critical care nurses including nurses' stressors in intensive care unit (ICU),~     perceived stress, trait and state anxieties; the third aim was to evaluate their impact on~     the clinical outcomes; and the fourth aim was comparing KAP and psychological factors with~     clinical outcomes.~   "
55683|NCT02838147|"~     Gestational diabetes mellitus (GDM) is defined as carbohydrate intolerance first diagnosed~     during pregnancy [1]. It is associated with adverse pregnancy outcome for the mother, and the~     fetus with consequences regarding future health and development of the neonate. Maternal~     consequences include increased rate of operative and cesarean delivery, hypertensive~     disorders during pregnancy and future risk for type 2 diabetes mellitus (T2DM) as well as~     other aspects of the metabolic syndrome, such as obesity, cardiovascular morbidities and~     recurrent GDM [2-4]. Also, children born to mothers affected by gestational hypertension have~     been found to have higher body mass index (BMI), systolic blood pressure, glucose and insulin~     levels [5]; this risk extends into adulthood, with an 8-fold increased risk of type 2~     diabetes among young adults exposed to gestational diabetes during fetal life [6].~      Of all types of diabetes, GDM accounts for approximately 90-95% of all cases [4, 7]. It~     complicates up to 14% of all pregnancies. Its prevalence is increasing and parallels the~     rising incidence of type 2 diabetes mellitus worldwide [3,4]. Risk factors for developing GDM~     in pregnancy include obesity, previously GDM, glycosuria, family history, ethnicity and~     hypertension [5,6].~   "
55684|NCT02838134|"~     Postoperative recovery after live donor nephrectomy (LDN) is largely determined by the~     consequences of postoperative pain and analgesia consumptions. The investigators' goal is to~     establish the relationship between the use of deep neuromuscular blockade (NMB) during~     laparoscopic donor nephrectomy (LDN) and the early quality of recovery. Therefore, the~     investigators designed a trial in which patients scheduled for living donor nephrectomy are~     randomized into a group with deep NMB or moderate NMB. The primary outcome measurement will~     be the Quality of Recovery-40 questionnaire (overall score) at 48 hours after extubation.~   "
55685|NCT02838121|"~     Periprosthetic bone loss caused by stress-shielding effect, a phenomenon of bone atrophy~     under mechanical unloading after THR implantation, further compromises the longevity of~     implant. The prospective randomized study is aimed to investigate the periprosthetic bone~     loss after primary total hip replacements.~   "
55686|NCT02838108|"~     This is an observational study examining outcomes and treatment patterns in a community-based~     cohort of subjects with Chronic obstructive pulmonary disease (COPD) who are based in the~     Kannapolis, NC area.~   "
55687|NCT02838095|"~     To examine the neurobehavioural responses to two successive cycles of sleep restriction and~     recovery in adolescents, and to determine the benefits of napping on cognitive performance,~     alertness, and mood. 57 participants, aged 15 to 19 years old, were divided into nap and~     no-nap groups. Both groups underwent two cycles of sleep restriction and recovery over 15~     days. The nap group received an afternoon sleep opportunity lasting 1 hour.~   "
55688|NCT02838082|"~     OSABI is a pilot study of a sleep hygiene protocol for sleep disruptions associated with TBI~     during inpatient rehabilitation. Twenty participants will be allocated (by minimization)~     either into a standard of care protocol or a sleep hygiene protocol for 4 weeks. Sleep~     efficiency (via actigraphy), post traumatic amnesia (OLOG), agitation (Agitated Behavior~     Scale) and cognitive function (Confusion Assessment Protocol) will be monitored during the~     trial period to examine relationships among them.~   "
55689|NCT02838069|"~     ASCs will be administered via intra-articular use into the knee joint affected by OA where~     they are expected to exert their therapeutic effects.~      The objective of this clinical trial is to generate efficacy and tolerability profiles of~     single injections of 2 dosages of autologous ASCs versus standard of care (placebo), when~     administered locally into a knee joint affected by OA after in vitro cell expansion. The~     potential of ASC to lead to a disease-modifying therapeutic option for the treatment of this~     chronic and debilitating disease will be assessed by MRI after 1 and 2 years.~      This will be a phase IIb, multi-centre, prospective, randomized, double-blind study,~     comparing culture-expanded autologous ASC with placebo.~   "
55690|NCT02838056|"~     Traditionally, placement of the epidural catheter is based on hand feel of passing through~     the ligamentum flavum as well as loss of resistance while injecting the air through the~     needle. However, both are subjective and not necessarily encountered consistently. Moreover,~     the onset of sensory block is usually slow, thus making confirmation of catheter position a~     tough task and may delay the turnover of the operating room. The only way to confirm the~     catheter position objectively without delaying surgery is to find a reliable indicator within~     minutes of local anesthetic injection. In this study, we try to use the change of temperature~     in the big toe as a surrogate indicator of correct epidural catheterization.~   "
55691|NCT02838043|"~     This study will be an 8-week open-label pilot study examining subjective and objective~     changes in mood, anxiety, cognition, and sleep before and after the introduction of a~     probiotic supplement containing Lactobacillus helveticus and Bifidobacterium longum in 10~     treatment-naïve participants diagnosed with major depressive disorder (MDD). In order to~     examine the full composition of the micro biome, the investigators will also be collecting~     and analyzing fecal samples as well as blood samples to examine changes in plasma levels of~     inflammatory markers, 5-HT, and tryptophan in order to look at possible underlying mechanisms~     of any changes seen.~   "
55729|NCT02837549|"~     The purpose of this study is to determine the feasibility and preliminary effects of a novel~     treatment approach to improve arm function in patients with scleroderma who have upper~     extremity contractures. It is a Phase 1, one arm trial in which participants will be assessed~     at baseline, 4 weeks, and 8 weeks. The rehabilitation intervention will involve 8 individual~     sessions with an occupational therapist. Feasibility of the procedures is a major focus of~     this project.~   "
60445|NCT02775682|"~     The purpose of this study is to determine whether patients with epilepsy exhibiting impaired~     dCA, which may contribute to subsequent stroke.~   "
55692|NCT02838030|"~     Worldwide, the incidence of preeclampsia ranges from 2 to 10% of pregnancies. The World~     Health Organization (WHO) estimates that the incidence of preeclampsia is seven times higher~     in developing countries than in developed (2.8% and 0.4%). In Mexico it is estimated that~     preeclampsia - eclampsia is a major cause of maternal and perinatal morbidity and mortality.~     Because it is an idiopathic heterogeneous syndrome associated with endothelial damage, so far~     there is no effective treatment to decrease the morbidity and mortality of this entity, so it~     is necessary to strengthen prevention; the use of aspirin alone is inconclusive, in addition~     to the information the investigators have reduced the effect of these strategies on arterial~     stiffness; Moreover, it has been observed that L-arginine lowers blood pressure in this~     population. It is for this that is of interest to know the efficacy and safety of the~     combination of L-arginine low dose, which is known as an important eNOS in NO production~     substrate, and aspirin for its qualities of antiinflammatory and anticoagulant in the~     prevention of preeclampsia and also determine their effect on arterial stiffness as a~     noninvasive method, as is the applanation tonometry.~   "
55693|NCT02838017|"~     The goal of this project is to identify a strategy to reduce wound complications in women who~     undergo cesarean delivery by Pfannenstiel skin incision. Currently, many Pfannenstiel skin~     incisions are closed by subcuticular sutures followed by either placement of Steri-Strips or~     Tissue Adhesive. Either Steri-Strips or Tissue Adhesive can be placed over the wound as a~     covering but it is unclear which may reduce wound complication rates. The hypothesis of this~     study is that Tissue Adhesive will result in a reduction in wound complication rates when~     compared to Steri-Strips. Previously published studies in non-obstetric populations have~     identified Tissue Adhesive as a potential intervention to reduce wound complications. The~     eligible population for this study will include women at NorthShore University HealthSystem~     Evanston Hospital and University of Chicago Hospital who will undergo primary or repeat~     cesarean delivery via Pfannenstiel skin incision. Women in the study will be randomized to~     receive either Steri-Strips or Tissue Adhesive. The primary outcome to be evaluated will be~     wound complication which will include wound infection (cellulitis or subcutaneous infection),~     wound separation (partial or complete), wound seroma/hematoma. Secondary endpoints to be~     investigated include cosmetic outcome, patient satisfaction, cost comparison, and difference~     in total time for application.~   "
55694|NCT02838004|"~     This is an interventional, non-controlled, multicenter international trial with a prospective~     design on one cohort of patients.~   "
55695|NCT02837991|"~     This is a study to determine the safety of CDX-014 and effectiveness (how well the drug~     works).~   "
55696|NCT02837978|"~     This study is designed to observed prospectively the efficacy and safety of 6 months~     treatment of Tacrolimus alone or with methotrexate (MTX) in moderate and severe Chinese RA~     patients who shown insufficiency response or intolerance to DMARDs~   "
55697|NCT02837965|"~     The study is an observational, multi-center, prospective, non-interventional and open-label~     data collection study assessing outcomes, treatment patterns, adverse events and costs in~     patients diagnosed with bullous pemphigoid. The patient enrollment period will be 1 year with~     a follow-up (observation period) of 1 year for each patient. Four dermatology centres in~     France will participate. The hypothesis to be answered by the study is that superpotent~     topical corticosteroid therapy is properly used to treat bullous pemphigoid in real-world~     life as recommended by French guidelines and whether this treatment influences the medical~     costs by comparison with systemic therapies (e.g. methotrexate or prednisone).~   "
55698|NCT02837952|"~     This study is being conducted to determine the overall analgesic efficacy and safety of a~     fixed-dose ibuprofen 250 mg / acetaminophen 500 mg formulation compared to placebo in~     subjects who are experiencing post operative pain following surgical extraction of 3 or more~     third molar teeth. A review of any reported adverse events will also be completed.~   "
55699|NCT02837939|"~     This study is aimed to assess the efficacy of Human derived Transfer factor ( T-lymphocytes~     homogenate that contains small molecular weight (10 kDa) molecules: various IFNs, ILs,~     chemokines, endorfins, heat shock proteins) in decreasing rate and/or severity of infections~     in acute or chronic decompensations of liver cirrhosis and acute on chronic liver failure..~   "
55700|NCT02837926|"~     The study aims to identify global and local determinants of HPV vaccine acceptability, HPV~     vaccine uptake and compliance as well as identify logistics and programmatic issues in each~     country to offer the HPV vaccine, as a potential cervical cancer prevention strategy, to~     mid-aged women attending screening.~   "
55701|NCT02837913|"~     The primary aim of the current study will be to determine if the use of an underbody heating~     mattress during cesarean sections will decrease the incidence of postoperative hypothermia,~     defined as core temperature less than 36C, and if hypothermia occurs, time to normothermia.~     As part of the primary outcome the difference in the incidence of shivering, its severity,~     and need for treatment will be investigated. As a secondary goal other maternal perioperative~     outcomes will be studied i.e. estimated blood loss, change in hemoglobin level on the morning~     after surgery ie postop day 1, need for blood transfusion, rate of wound infections, length~     of hospital stay, maternal satisfaction, time to first breastfeeding, time to first 'skin to~     skin' contact. The relationship between maternal hypothermia and newborn outcomes of~     temperature and APGAR scores will also be evaluated.~      Active preoperative and intraoperative warming may prevents inadvertent perioperative~     hypothermia and may be beneficial for pregnant patients undergoing cesarean delivery. The~     underbody warming mattress may be a step towards finding a suitable form of warming that is~     comfortable for awake patients, does not interfere with skin to skin contact and~     maternal-fetal bonding.~   "
55702|NCT02837900|"~     The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy~     of a second course of TPX-100 administered by intra-articular injection to subjects with~     osteoarthritis of the knee who participated in study TPX-100-1.~   "
55703|NCT02837887|"~     This randomized clinical trial studies how well a computerized cognitive behavior therapy~     program works in treating depression in patients with cancer. The cognitive behavior therapy~     program uses a series of internet-delivered sessions intended to help patients identify and~     change problematic patterns of thinking and behavior that maintain depression.~   "
57310|NCT02816853|"~     The purpose of this study is to assess the effects of domperidone on the QTc interval~     duration in Chinese healthy adult participants after multiple domperidone doses of 10~     milligram (mg) 3 times a day (tid) and 20 mg tid.~   "
55705|NCT02837861|"~     A randomized, parallel-group, pilot study comparing the effect of the early addition of~     intravenous protein to enteral feeding as tolerated versus enteral feedings as tolerated~     alone immediately post traumatic injury.~      Primary: To determine that early and adequate nutritional support will improve protein~     economy in the first week post -injury as measured by nitrogen balance. We hypothesize that~     an improvement in nitrogen balance with early maximized protein intake will support the~     production of acute phase proteins, major antioxidants and the inflammatory response.~      Secondary: Through the use of mass spectrometry (MS) and nuclear magnetic resonance (NMR)~     technologies we will determine that our plan for early and adequate nutritional support with~     adequate protein from day one post injury will alter the metabolomics profile when compared~     to routine nutritional support.~      Tertiary: For Specific Aim 3 we will measure several pro- and anti-inflammatory cytokines and~     soluble proteins.~   "
55706|NCT02837848|"~     Rotator cuff tendinopathy (RCT) is the most frequent cause of shoulder pain. RCT is~     frequently termed as impingement syndrome, based on the underlying mechanism in which the~     subacromial space soft tissues (subacromial bursa, rotator cuff tendons and long head of the~     biceps tendon) get encroached under the coracoacromial arch when the arm is elevated. RCT~     contributes in the decrease in quality of life and function, and in inducing work~     incapacities and sleep disorders.~      Exercises, as conservative management, were shown to be effective in increasing function and~     in decreasing pain related to RCT. However, the lack of studies comparing different types of~     exercises (i.e. concentric, eccentric, scapular strengthening, proprioceptive, coactivation)~     is reported by many systematic reviews. One type of exercise, coactivation strengthening,~     could be more efficient. Coactivation strengthening implies a recruitment of the pectoralis~     major and the latissimus dorsi while performing regular strengthening. When theses muscles~     are recruited, the medio-inferior orientation of their tendons creates a force vector that~     limits the superior translation of the humeral head, thus limits the subacromial narrowing.~      The aim of this study is to evaluate the efficacy of coactivation strengthening exercises in~     patient with RCT compared to regular strengthening exercises. Forty-two participants~     diagnosed with RCT by an orthopaedic surgeon following a standardized protocol will be~     randomised to either coactivation or regular strengthening exercises. Participants will~     perform a 6-week exercise protocols. Outcomes will be measured at baseline, and at three,~     six, 12, 18 and 24 weeks. The primary outcome is function assessed with the Disabilities of~     arm, shoulder and Hand (DASH) questionnaire. Secondary outcomes focus on pain (visual analog~     scale), quality of life (Western Ontario Rotator Cuff Index), impression of change (Patient~     Global Impression of Change), subacromial distance (ultrasonography) and muscular strength~     (manual dynamometer). Investigators expect that coactivation strengthening exercises will be~     more efficient over the short and long term.~      This trial will provide data to guide clinicians in the treatment of RCT to reduce recovery~     time and to bring patients back as quickly as possible to work or usual function.~   "
55707|NCT02837835|"~     Ceftazidime is a beta-lactam compound that exerts a time-dependent bactericidal effect.~     Numerous arguments are in favor of continuous administration of ceftazidime, both for reasons~     of clinical efficacy and to preserve bacteriological mutation. The investigators report a~     prospective, single-center, parallel-group, randomized, controlled trial comparing two modes~     of administration of ceftazidime, namely, continuous administration (loading dose of 20 mg/kg~     of body weight followed by 60 mg/kg/day) versus intermittent administration (20 mg/kg over 30~     min every 8 h) in 34 patients with ventilator-associated pneumonia due to Gram-negative~     bacilli. The study was performed over 48 h with 13 and 18 assessments of serum ceftazidime in~     the continuous-infusion group (group A) and the intermittent-fusion group (group B),~     respectively. Bronchoalveolar lavage (BAL) was performed at steady state in both groups at 44~     h to determine ceftazidime levels in the epithelial lining fluid. The investigators chose a~     predefined threshold of 20 mg/liter for serum concentrations of ceftazidime because of~     ecological conditions in our center.~   "
55708|NCT02837822|"~     It's well known that Spinal cord stimulation (SCS) changes the perception of chronic pain in~     the area stimulated by epidural electrodes. However, we don't know the effect of this type of~     stimulation on the perception of external sensations (temperature, touch, pressure, and~     vibration) and sharp pain. Quantitative sensory testing (QST) is used to quantify~     somatosensory phenotype. This QST battery tests different subtypes of nerve fibres (Aβ, Aδ~     and C) involved in the transduction of sensory information from the periphery to the spinal~     cord.~      The purpose of this study is to evaluate the effects of the SCS on sensory perceptions of~     patients with chronic pain (CRPS, FBSS). Sensorial perception tests will be carried out in~     accordance with a standardized procedure (Rolke et al. Pain, 2006). For non-implanted~     patients, an initial visit will be conducted before the operation. For all participants, two~     other visits will take place at least 6 months after the operation to perform the tests with~     and without stimulation.~   "
55709|NCT02837809|"~     The MILD project is a randomized lung cancer screening trial whose primary aim is to evaluate~     the impact on mortality of early lung cancer detection through LDCT (low-dose computed~     tomography) in 2 groups: a control group undergoing a program of primary prevention with~     pulmonary function test evaluation and a group undergoing a periodic spiral CT associated~     with primary prevention and pulmonary function test evaluation. This last one is also~     randomized in two arms: yearly low-dose CT vs CT every 2 years.~      MILD trial comprehensive design combines for the first time primary prevention (smoking~     cessation) with early detection, and molecular risk profile through assessing the value of~     blood and tissue biomarkers.~   "
55710|NCT02837796|"~     The investigators think that the two techniques of TOT (inside-out and outside-in) procedures~     both statistically improve the sexual functions, psychosocial state and quality of life after~     the surgery. Additionally postoperative physical and behavioral-emotional scores in PISQ-12~     were statistically more increase in inside-out group than the outside-in group.~   "
55711|NCT02837783|"~     The objective of this trial is to determine the effect of linaclotide on abdominal girth in~     irritable bowel syndrome with constipation (IBS-C) participants with the baseline symptoms of~     abdominal bloating and an increased abdominal girth.~   "
55712|NCT02837770|"~     The analgestic efffect of Diclofenac Sodium 0.1% Eye Drops and a combination of Diclofenac~     Sodium 0.1% Eye Drops and oral Diclofenac Sodium sustained-release 75mg tablets on pain~     related to intravitreal injections will be evalutated.~      Pain perception will be assessed by the Short Form of the McGill Pain Questionnaire.~   "
55713|NCT02837757|"~     Everolimus is an inhibitor of mammalian target of rapamycin, approved in patients with~     metastatic renal cell carcinoma.~      The objective of this study is to investigated the influence of everolimus immune modulation~     on antitumor efficacy .~   "
55714|NCT02837744|"~     To evaluate Safety and Efficacy of Axiostat® hemostatic dressing as compared to Standard~     Institutional Care product in terms of time to achieve hemostasis, post application~     complication and comfort levels of patients.~   "
55715|NCT02837731|"~     This study assesses the mean difference in fluid balance at ICU discharge and associated~     patient outcomes, based on a dynamic assessment of fluid responsiveness in septic patients~     with refractory hypotension in an ICU setting.~   "
55716|NCT02837718|"~     Background Peripheral nerve blocks with use of USG allowed visualisation of the structures~     and nerves and made the block administrations safe, quick and comfortable. However there are~     few publications concerning the minimum local anesthetic volume capable of providing blocks.~     In this study the investigastors aimed to find Minimum Effective Volume Of Local Anesthetic~     For Ultrasound-Guided Axillary Brachial Plexus Block in hand, elbow and forehand operations.~      Materials & Methods A total of 55 ASA I-II patients underwent hand surgery operation by~     administering USG guided-axillary brachial plexus blockage were included in the study. Ulnar,~     median and radial nerves were seen and the minimum effective local anesthetic volume was~     investigated starting with total 21 ml of %0.5 bupivacain. After accomplishing the blockage,~     volume was decreased by 0.5 for each nerves. Block administration time, block onset times,~     anesthesia times and time to first analgesic requirement were recorded.~   "
55717|NCT02837705|"~     The human Prion diseases can be classified into sporadic, acquired and inherited forms.~     Inherited forms usually manifest in higher age so there have to be factors preventing Prion~     propagation in young mutation carriers. Antibodies against the flexible tail of Prions have~     been shown to be protective in mice. The investigators intend to screen mutation carriers and~     controls for the presence of Prion autoantibodies.~   "
55718|NCT02837692|"~     The purpose of this study is to assess the pharmacokinetics of single-dose evening~     administration of JNJ-42847922 in elderly non-Asian adults compared with weight- and~     gender-matched young healthy non-Asian adults and to assess the pharmacokinetics of~     single-dose evening administration of JNJ-42847922 in healthy Japanese adults.~   "
55719|NCT02837679|"~     The study is a randomized study of patients living in four municipalities in Eastern Jutland.~     After geriatric assessment half of the patients will be offered a tailor-made intervention in~     their homes. The follow-up will last for at least 90 days and include treatment of the~     patients' multimorbidity, e.g. of dehydration, anaemia, infections, and malnutrition. The~     other half of the patients, the results of the assessment and recommendations will be given~     to the patients and their general practitioner.~      The primary efficacy variables are accomplishment of planned cancer treatment, reduction of~     complications and admissions to hospital and increased quality of life,.~      If geriatric assessment and a tailor-made follow-up result in a better quality of life with~     less complications and admissions the offer may be extended to a longer period, younger age~     groups and other cancer diagnoses.~   "
55720|NCT02837666|"~     The purpose of this study is to demonstrate that Spirulina maxima intake and a dosed physical~     activity program will decrease, both independently and synergistically, cardiovascular risks~     (Dyslipidemias and oxidative stress) in overweight and obese subjects.~   "
55721|NCT02837653|"~     Objective: To determine the influence of a counseling of physical activity (PA) versus usual~     care (UC) in the magnitude of chronic pain (CP) in patients diagnosed with chronic low back~     pain (CLBP).~      Methods: A total of 64 subjects with (CLBP) and older were randomly divided into two groups:~     an experimental group (UC) + counseling of (AF) and control group (UC). Each group consisted~     of 32 participants and were evaluated twice (pre and post-intervention), being spaced one~     month, both groups received telephone follow-up for their participation. The primary endpoint~     was the magnitude of the (CP) measured by the tool grading scale of chronic pain (EGDC),~     while as secondary were considered the cardiovascular risk factors, catastrophism,~     kinesiofobia, disabled by back pain, quality of life, anxiety and depression and the (FA).~   "
55722|NCT02837640|"~     The purpose of this study is to evaluate the effect of L-Dopa on the progression of retinitis~     pigmentosa.~   "
55723|NCT02837627|"~     Due to several promoting factors, gastro-esophageal reflux (GER) is very frequent in preterm~     infants. To limit the potentially harmful widespread of pharmacological treatment, a~     step-wise approach, which firstly undertakes conservative strategies, is currently considered~     the best choice to manage GER in the preterm population. Among the most common conservative~     strategies, postural measures seem to effectively reduce GER features in symptomatic preterm~     babies, whereas feed thickening is almost ineffective.~      Due to their prematurity, preterm infants <34 weeks gestation are often unable to coordinate~     sucking, swallowing and breathing, thus requiring a feeding tube to ensure adequate enteral~     intakes. Continuous feeding and boluses are the most common techniques of enteral tube~     feeding in Neonatal Intensive Care Units; at present, however, the effects of these~     techniques on GER features have not been clearly established.~      This observational, prospective and explorative study primarily aims to evaluate the effect~     of different techniques of enteral tube feeding on GER frequency and features in symptomatic~     preterm infants (gestational age ≤33 weeks) undergoing a diagnostic combined pH and multiple~     intraluminal impedance (pH-MII) for GER evaluation.~   "
55724|NCT02837614|"~     The study composed of sixty patients, each of whom required surgical extraction of a single~     impacted mandibular third molar under local anaesthesia. The patients were randomly allocated~     to one of 3 groups of 20 each. The three groups were categorized as Group A (intramuscular~     dexamethasone), Group B (submucosal dexamethasone) and Group C (control). The objective~     measurements of facial pain, swelling, and trismus was performed by an independent examiner~     at baseline (preoperatively), and at days 1, 3, and 7 postoperatively.~   "
55725|NCT02837601|"~     A prospective, randomized, controlled single-center clinical Study designed to evaluate~     Physician Preference related to the use of the SurgiQuest AirSeal® Insufflation System (AIS)~     at low vs. higher pressures for the Management of pneumoperitoneum. Subjects will be~     randomized in a 1:1 treatment device to control ratio into one of two (2) different study~     arms:~        1. AIS with an insufflation pressure target of 9mmHg ±1mmHg; or~        2. AIS with an insufflation pressure target of 15mmHg ±1mmHg.~   "
55726|NCT02837588|"~     -  Treatment at pelvic floor with hyperactivity with hyperthermy electrode MJS~        -  MJS electrode is effective for transvaginal treatment at pelvic pain patients~        -  Hyperthermy treatment with MJS electrode is more effective to usual drugs treatment~   "
55727|NCT02837575|"~     The purpose of this trial is to evaluate the safety and efficacy of a therapeutic DNA vaccine~     in adults with symptomatic herpes simplex virus type 2 (i.e., genital herpes).~   "
55730|NCT02837536|"~     The goal of this study is to evaluate the agreement between intraocular pressure (IOP)~     measurements taken by iCare, held in both vertical and horizontal positions. In addition,~     iCare measurements will be compared against pneumotonometry measurements to assess for~     accuracy.~   "
55738|NCT02837432|"~     There is good evidence to suggest that the pathological version of sadness that people with~     Major Depression experience could be caused by the failure of the hormone cortisol to~     properly inhibit sadness-related brain activity in the subgenual cingulate cortex. This~     project investigates if the subgenual cingulate cortex has become insensitive to cortisol in~     patients with depression and tests for variants of the cortisol receptor genes that could~     predispose individuals to develop cortisol insensitivity.~   "
55739|NCT02837419|"~     This study evaluates patients on ECLS treatment as considered appropriate with mortality and~     health related Quality of life and costs.~   "
55740|NCT02837406|"~     The aim is to evaluate a national health information technology-based program to improve~     healthcare coordination and access to information.~   "
55741|NCT02837393|"~     The investigators objective is to determine if urinary electrolyte abnormalities exist in~     only one or both kidneys in participants with and without a history of kidney stones. To meet~     this objective, the investigators are going to take urine samples from each kidney at the~     time of kidney stone surgery. The samples will then be analyzed for absolute and relative~     differences in the concentrations of urine electrolytes, such as calcium.~   "
55742|NCT02837380|"~     This is an open-label study to evaluate the PK of FF/UMEC/VI in dose combinations of~     100/62.5/25 mcg after single and repeat dose administration from a DPI in healthy Chinese~     subjects. This study will evaluate the systemic pharmacokinetics (PK), of FF/UMEC/VI in~     Chinese healthy population when administered using dry powder inhaler (DPI)as a blended~     combination of UMEC/VI in one strip and FF in the second strip in dose combinations of~     100/62.5/25 mcg. The triple, fixed dose combination product Fluticasone furoate(FF)/~     Vilanterol (VI) /Umeclidinium bromide (UMEC) with new configuration enables the delivery of~     inhaled long-acting muscarinic antagonist (LAMA), Long-acting beta2 agonist (LABA) and~     inhaled corticosteroid (ICS) from a single device. Approximately 16 subjects will be enrolled~     in the study. After taking into account the allowable time windows for screening, treatment~     and follow-up, a subject will be in the study for a maximum duration of 6-7 weeks.~   "
55743|NCT02837367|"~     The NutriGen project will be using nutrigenomic methods to determine the effectiveness of~     treatments with specific dietary foods, on the basis of genetic risk predisposition (genetic~     signature) of obese individuals.~   "
55744|NCT02837354|"~     The Cerebral Amyloid angiopathy (CAA) is the leading cause of cortical hemorrhage after 65~     years. The presence of cerebral infarction is also reported anatomically in the AAC. MRI~     studies of these infarcts are rare. They are described as punctate, cortical silent.~     Frequency and pathophysiology is poorly understood. The investigators put the question of a~     link with hemorrhagic lesions of the AAC.~   "
55745|NCT02837341|"~     Respiratory rate as an important predictor for adverse events, but still a neglected vital~     sign.~      Precise and simple measurement of the respiratory rate in volunteers by a new electronic~     camera device in different settings.~   "
55746|NCT02837328|"~     The primary objective of this research is to determine whether oral magnesium supplementation~     in healthy, community-living individuals will be associated with reductions in the burden of~     arrhythmias in the upper chambers of the heart (supraventricular arrhythmias).~   "
55747|NCT02837315|"~     The purpose of this study is to evaluate the efficacy of a Substance-Free Activity Session~     (SFAS) as a supplement to a brief motivation intervention (BMI) in reducing marijuana use and~     drug-related consequences in college student~   "
55748|NCT02837302|"~     Protein-calorie malnutrition is frequently observed in patients with advanced liver~     cirrhosis. There have been continued interests in potential benefits of long-term oral~     branched-chain amino acid supplement in improving severity of liver disease. However, there~     are limited evidences in literature. The aim of this study is to evaluate the efficacy of~     oral branched-chain amino acid in patients with advanced liver cirrhosis.~   "
55749|NCT02837289|"~     Introduction: Hip motor control deficit and neuromuscular disorders of the gluteus medius~     influence the mechanics of patellofemoral joints through increased dynamic knee valgus and~     can lead to Patellofemoral Pain Syndrome (PFPS). Mechanoreceptors can be stimulated by an~     elastic tape, which sends desired tactile cues via afferent improving the functional support~     of the musculoskeletal system.~      Objective: To analyze the response to hip stabilizer muscle activation in street runners with~     PFPS through the application of elastic tape therapy.~      Methods: The investigators evaluated street runners between the ages of 18 and 45, who run at~     least 5km/week and had been suffering from pain for at least 3 months. The volunteers had~     been assessed in relation to their measurements, experience of pain and training routine,~     their medius muscle (GM) and biceps femoris muscle (BF) had also been tested with surface~     electromyography through pre-determined performance tests. The participants of both groups~     wore a bandage for 6 weeks (1 per week). However for the participants of the placebo group~     the investigators applied a different anatomical path without tension, eliminating all the~     therapeutic elements. The volunteers were reassessed following the trial.~      Hypothesis: Expected to observe that elastic tape therapy do result in any improvement in the~     activation of hip muscles and improvement of pain in street runners with patellofemoral pain~     syndrome.~   "
55750|NCT02837276|"~     This pilot study aims at investigating the relationship between intermittent hypoxemia (IH)~     and acute kidney injury (AKI) in preterm infants.~      AIM 1: Test the hypothesis that intermittent hypoxemia is associated kidney injury in preterm~     infants, as reflected by a rise in serum creatinine.~      AIM 2: Test the hypothesis that there is rise in acute kidney injury urinary biomarkers with~     increased intermittent hypoxemia.~   "
55751|NCT02837263|"~     The purpose of this research study is:~        -  To find out how safe the study drug, pembrolizumab, is when combined with stereotactic~          body radiotherapy (SBRT) to the liver.~        -  To see how well subjects can tolerate treatment with pembrolizumab and SBRT.~        -  To find out how often colorectal cancer comes back 1 year after surgically removing all~          known disease and being treated with SBRT and pembrolizumab.~   "
55752|NCT02837250|"~     RECRUITING NOW AT www.pos4health.org~      This project has developed a patient-centered eHealth intervention; specifically, an Internet~     intervention, targeting multiple issues and nonadherence in HIV. The intervention,~     Pos4Health, includes peer role model videos and evidence-based interactions to promote~     understanding, coping with, and managing risk factors for nonadherence to ART, and to improve~     nonadherence itself. In this Pilot Trial, investigators will test the eHealth intervention~     Pos4Health with PLWH who reside outside urban centers.~   "
55753|NCT02837237|"~     This study explores the use of KBP-5074 in patients with advanced stages of Chronic Kidney~     Disease (CKD) (including patients with severe renal impairment and those on hemodialysis~     [HD]) and to assess the safety, tolerability, and pharmacokinetics (PK) of single doses of~     KBP-5074 in male and female patients with severe CKD (defined as estimated glomerular~     filtration rate [eGFR] ≥15 mL/min/1.73 m2 and ≤29 mL/min/1.73 m2, based on the Modification~     of Diet in Renal Disease [MDRD] equation) and a subset of patients requiring HD.~   "
55754|NCT02837224|"~     Retained surgical items (e.g. sponges, needles, and instruments) remain the most frequently~     reported serious adverse event for five of the last six years. Retained surgical sponges have~     resulted in negative patient outcomes (reoperation, readmission/prolonged hospital stay,~     infection, fistulas/ bowel obstructions, and death). The national standard for prevention of~     retained surgical sponges relies heavily on manual counting several times before, during, and~     after the surgical procedure. If a sponge is missing, a series of steps are taken to~     reconcile the count. These steps require extra time and pull personnel away from other~     competing priorities. If the final closing count remains incorrect, it is common practice to~     obtain an intraoperative radiograph to rule out retention of a surgical sponge. This X-Ray is~     expensive and increases the time required for the surgery.~      Novel technology using a radiofrequency (RF) is now available for detecting and preventing~     retained surgical sponges. The objective of this study is to evaluate the in-use~     effectiveness of a radiofrequency (RF) surgical sponge detection system for reducing the cost~     of searching for sponges and prevention of incorrect counts.~   "
55755|NCT02837211|"~     TREND is a pilot randomized trial comparing two alternative methods of initiating a~     low-calorie weight loss diet. The study will compare the traditional diet initiation of~     abruptly dropping energy intake to 1000 kcal/day for women and 1200 kcal/day for men versus a~     6 week tapering of energy intake from a baseline level. These two approaches will be compared~     with respect to their impact on energy regulatory systems of the body, weight loss and other~     measures, up to a year after diet initiation.~   "
55756|NCT02837198|"~     To investigate the pharmacodynamics, pharmacokinetics and safety of 7-day-repeated doses of~     FYU-981 administered orally to male hyperuricemic patients with uric acid-overproduction or~     uric acid-underexcretion type.~      In addition, to investigate the additive effects of the combination of FYU-981 and~     topiroxostat administered orally to male hyperuricemic patients with uric acid-overproduction~     type.~   "
55757|NCT02837185|"~     This study will look into the effects of Botulinum Toxin in patients with primary cervical~     dystonia. The effects will be determined by neck muscle activity measurements and brain~     function activity measurements. The goal of the study is to try to identify markers of the~     effects of Botulinum toxin.~   "
55758|NCT02837172|"~     This project will evaluate the utility of diffusion tensor imaging (DTI) as an adjunctive~     method to improve early diagnosis of Parkinson's disease (PD). Two populations will be~     evaluated in this study: 1) Individuals with uncertain PD diagnosis who receive a DaTscan,~     and 2) individuals with well characterized PD and healthy controls, drawn from the fully~     enrolled Parkinson's Progression Markers Initiative (PPMI) PD and control cohorts.~   "
55759|NCT02837159|"~     The purpose of this randomized study is to assess the efficacy of a mobile application for~     the promotion of healthy lifestyle habits (diet and exercise) in colorectal cancer survivors~     (CCR).~   "
55760|NCT02837146|"~     This study is aimed at assessing the kinetics of the ultrasound (US) response in DMARD-naive~     very early rheumatoid arthritis (RA) patients treated with tocilizumab (TCZ) and methotrexate~     (MTX).~   "
55761|NCT02837133|"~     Typically a course of yoga therapy for stress management takes place over a week, however,~     investigators are often asked to provide a single session for workers. The aim of this study~     is to assess the benefits of a single session of an integrated yoga program compared with~     other relaxation techniques for the staff of schools.~   "
55762|NCT02837120|"~     Acute non-traumatic chest pain is a common kind of symptom in extremely critical condition,~     with various pathogenesis and different level of risk . Chest pain in high risk takes 1/3 of~     that. It mainly includes acute coronary syndrome (including myocardial infarction and~     unstable angina pectoris, accounted for over 95% of chest pain in high risk), aortic~     dissection, pulmonary embolism etc, and is in high lethality and deformity.~      The investigators do the research :~        1. To study the diagnosis and management condition of acute chest pain in extremely~          critical condition for last ten or more years in Qilu Hospital,Shandong University.~        2. To discuss the significance of key accompanying symptoms(for example radiating pain,~          chest distress, sweating, nausea etc), physical signs and lab examination in early~          diagnosis and risk stratification of acute chest pain in extremely critical condition.~        3. To study the effect factors of thrombus burden in STEMI patients, at the same time,~          creat a a simple, practical and scientific method of blood clots classification.~   "
55763|NCT02837107|"~     While it is well accepted that a low level of RONS production is necessary to maintain~     physiological function, too much formation of RONS are believed to participate in~     biomolecules damage. Damage of lipids, proteins and DNA/RNA, to cellular and tissue level, as~     a consequence of oxidative stress has been linked to a number of serious diseases, including~     cancer, cardiovascular diseases (CVDs) such as hypertension and atherosclerosis,~     neurodegenerative diseases such as Parkinson's disease and Alzheimer's dementias, diabetes~     and the process of aging.~      The dietary intake of antioxidants is thought to play a major role in oxidative stress~     network. Many epidemiologic studies have reported an inverse association between vegetable~     and fruit consumption with reduced risk of chronic diseases, especially cancer and CVDs.~     However, although many clinical trials have been conducted with vitamins (E, C or their~     combinations) their in vivo protective effect remains uncertain. Therefore the possibility~     that the complex mixture of phytochemicals in foods may contribute to their protecting~     effects has been raised. In this concept, it is possible multiple compounds to act through~     complimentary or synergistic mechanisms to present a greater biologic effect than can be~     achieved by any individual component To investigate this hypothesis, a double-blind,~     randomized, and placebo-controlled clinical trial was conducted in order to investigate the~     effects of a multi-micronutrient supplement against oxidative stress in apparently healthy~     adults.~   "
60446|NCT02775669|"~     Investigators compare the ICP of two standard Spiegelberg ICP-probes in children, which~     underwent an operation due to craniosynostosis.~   "
55764|NCT02837094|"~     The study is a two centre, open-label, uncontrolled single group phase 1A study of C19-A3 GNP~     peptide (10 μg peptide equivalent content) administered via Nanopass microneedles every 28~     days for 8 weeks (3 doses), with follow-up for 6 weeks (14 weeks in total from first dose).~     Treatment will be given into the arm at a volume of 50ul.~      No blinding or randomisation will be performed. In keeping with standard phase 1 study~     designs, no placebo or control group is included as the primary aim is to establish whether~     there are any major unexpected safety issues in the use of this IMP for the first time in~     man. 8 subjects will be recruited at 2 centres: Cardiff, UK and Linköping, Sweden.~   "
55765|NCT02837081|"~     Antimicrobial stewardship program (ASP) is recommended to improve appropriate antimicrobial~     use, reduce bacterial resistance, unnecessary drug costs and enhance patient health outcomes.~     Two core strategies of ASP recommended as effective in guidelines are formulary restriction~     with drug preauthorization and prospective audit with feedback. Investigators will evaluate~     the effectiveness of the 2 strategies using antimicrobial utilization and patient outcomes.~   "
55766|NCT02837068|"~     The purpose of this study is to determine whether wheelchair handrail compensator plus~     rehabilitation training could do better than ordinary wheelchair plus rehabilitation training~     in relieving pain and improving daily life activity, upper limb motor function and quality of~     life for patients with hemiplegic shoulder pain.~   "
55767|NCT02837055|"~     It has been shown that videolaryngoscopy may be superior to direct laryngoscopy for~     endotracheal intubation in intensive care. Recently, an endotracheal tube with an integrated~     camera at its tip has been introduced (VivaSight-SL) allowing for direct visual confirmation~     of the tube's passage through the vocal cords during intubation.~      Patients who are requiring urgent or endotracheal intubation in intensive care are randomized~     to receive either a conventional intubation with direct laryngoscopy or to receive intubation~     with the VivaSight-SL-Tube. Primary outcome measures are first attempt success rate and~     number of attempts to successful intubation.~   "
55768|NCT02837042|"~     Penile squamous cell carcinoma (PSCC) is relatively rare but exhibits higher incidences in~     less developed countries. PSCC is a highly aggressive malignancy characterized by early~     spread. Pembrolizumab has recently been FDA-approved for the treatment of melanoma but will~     serve as the investigational agent for this penile cancer study.~   "
55769|NCT02837029|"~     The purpose of this study is to identify maximum tolerated dose (MTD), that is, the highest~     dose of the study drug nivolumab that does not cause unacceptable side effects, for~     combination treatment of nivolumab and yttrium Y 90 glass microspheres (Y-90). Also, to~     evaluate the efficacy (the effect of drug on your tumor) and the tolerability (the effect of~     the drug on your body) of nivolumab, when given with standard of care Y-90 (Therasphere).~     Nivolumab is currently Food and Drug Administration (FDA) approved for other cancers, but has~     not yet been investigated in advanced or refractory hepatocellular carcinoma. Nivolumab is an~     antibody (a human protein that sticks to a part of the tumor and/or immune cells) designed to~     allow the body's immune system to work against tumor cells. Y-90 is currently FDA approved~     for the treatment of hepatocellular carcinomas, but has not yet been investigated in~     combination with nivolumab for this disease.~   "
55770|NCT02837016|"~     The investigators propose a randomized controlled trial (RCT) to investigate the feasibility~     and efficacy of non-intrusive biofeedback devices that can be worn throughout the day in~     providing therapeutic cues to college students suffering from chronic anxiety. The~     biofeedback device detects physiological stress indices in real time (e.g., changes in~     breathing rate) and provides feedback (e.g., through minor vibration or text messages)~     serving as a cue to the wearer to recall therapeutic steps at exactly those moments they need~     to exert cognitive control. Students will be randomized in a 1) experimental group with~     biofeedback device and 2) experimental group without biofeedback device. Experimental groups~     will undergo an intervention that will strengthening cognitive control through~     mindfulness-based relaxation techniques. Outcome measures will include a multi-method~     approach collecting questionnaire, behavioral, and psycho-physiological indices of anxiety~     and self-control. The proposed study is innovative and has the potential to lead to more~     effective and cost-efficient types of intervention applications in the future.~   "
55771|NCT02837003|"~     To evaluate safety of reduction of dual antiplatelet therapy period to three months after~     implantation of Ultimaster sirolimus-eluting stent (U-SES).~      Additionally to investigate appropriateness of thienopyridine monotherapy with~     discontinuation of aspirin.~   "
55772|NCT02836990|"~     This study evaluates the clinical efficacy and cost effectiveness of Prevena Incision~     Management System versus Dermabond in preventing groin wound infections in patients who~     undergo vascular surgery requiring a groin wound. Half of the patients will receive Dermabond~     and the other half will receive the Prevena Incision Management System for their groin~     wounds.~   "
55773|NCT02836977|"~     Primary Objective:~      To compare 3-year disease free survival (DFS) of tegafur-uracil following adjuvant~     oxaliplatin-based regimen to observation following adjuvant oxaliplatin-based regimen in~     patients with stage III colon cancer after radical resection.~      Secondary Objectives:~        -  To assess 5-year overall survival (OS) in each arm~        -  To assess the safety profiles~   "
55774|NCT02836964|"~     To evaluate the clinical success, stability, radiographic bone level changes and~     peri-implants soft tissue parameter of the SLActive surface implant supporting single crowns~     restorations in early loading in the mandibular first molar region.~   "
55775|NCT02836951|"~     Novel biomarkers of traumatic brain injury (TBI) have been discovered in laboratory animal~     models. The objective of this study is to find whether similar markers are detectable in the~     body fluids of human subjects that have sustained a TBI.~   "
55776|NCT02836938|"~     It's the aim of this study to clarify, whether the non-invasive assessment of breath can~     serve as a novel clinical tool to assist in the diagnosis of CLAD. If different stages of BOS~     can be discriminated by the level of certain VOCs than there would also be a potential to~     actually predict the development at an early stage and would enable an earlier intervention.~   "
55777|NCT02836925|"~     This is a non-randomized, a single arm, phase II multicentre study of sofosbuvir plus~     ledipasvir (genotype 1 and 4) or sofosbuvir plus velpatasvir (genotype 2 and 3) for patients~     with hepatitis C virus-associated indolent B-cell lymphomas (HCV-RNA positive).~   "
55778|NCT02836912|"~     Pulmonary rehabilitation exercise is beneficial for individuals with chronic obstructive~     pulmonary disease (COPD). However, merely 30% patients know how to do the exercise correctly.~     Therefore, it is worthy to investigate the applications in clinical practice. In addition,~     there are no relative research in Taiwan to see effects of an 8-week pulmonary rehabilitation~     exercise in home care for the non-invasive ventilator-dependent elderly with COPD.~   "
55779|NCT02836899|"~     The purpose of this study is to determine whether nitric oxide is effective in the treatment~     of acute kidney injury in cardiac surgical patients with sign and laboratory data suggesting~     endothelial dysfunction undergoing prolonged cardiopulmonary bypass.~   "
55780|NCT02836886|"~     This study will be using this technique, called VirCapSeq-VERT to analyze the white blood~     cells of patients with Sézary syndrome. This could provide the foundation for future studies~     looking to understand the role that viruses play in the origin of Sézary syndrome. This could~     have important implications for the future development of new and effective therapies for the~     disease.~   "
55781|NCT02836873|"~     The purpose of this study is to investigate the effect of bexagliflozin in lowering~     hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM) and moderate~     renal impairment.~   "
55782|NCT02836860|"~     The purpose of this study is to compare combined tactile stimulation and verbal instruction~     to verbal instruction only on lumbar multifidus muscle activation in asymptomatic healthy~     adults and in patients with LBP.~   "
55783|NCT02836847|"~     The purpose of this study is to evaluate the feasibility, efficacy and safety of target~     therapy according to genomic and proteomic profiling combined with GEMOX in advanced or~     recurrent extrahepatic cholangiocarcinoma and gallbladder carcinoma.~   "
55784|NCT02836834|"~     The primary objective is to assess the safety and tolerability of JS-001 in subjects with~     various advanced or recurrent malignancies, including solid tumors and lymphomas, and to~     evaluate its preliminary efficacy.~      The secondary objectives are to: 1) characterize the single-dose and multi-dose~     pharmacokinetic (PK) profile of JS-001, 2) characterize the immunogenicity of JS-001; 3)~     assess the dose-efficacy relationship of JS-001 single agent, and 4) preliminarily evaluate~     biomarkers associated with the efficacy of JS-001.~      The exploratory objectives include to evaluate the consistency between biomarker detection~     results of archived tissue and fresh frozen tissue, and to assess the consistency of response~     using various response criteria (such as irRC, WHO, RECIST and irRECIST).~   "
55785|NCT02836821|"~     The primary purpose of this study is to investigate potential pharmacokinetic interaction in~     healthy volunteers when apatinib is administered in combination with rifampicin. Secondary~     objective is evaluating the safety and tolerability of apatinib alone and when~     co-administered with rifampicin.~   "
55786|NCT02836808|"~     Abstract: Empowerment interventions for chronic diseases are an evolving process. No~     agreement exists regarding the necessary components and methodologies to be applied.~     Systematic reviews have assessed the effect of self-management interventions. Improvements in~     illness beliefs, adherence to drug therapy and glucose monitoring have been reported. In the~     long term, no major changes have been achieved in weight, physical activity, smoking status,~     and depression scores.~      There is a need for additional studies. The Center for Comprehensive Care of Patients with~     Diabetes (CAIPaDi) program is an intervention designed to provide education and empowerment~     techniques (using simple low-cost interactive tools) over a short period of time followed by~     at-distance support using internet or cell phone technology. The target population consists~     of patients with type 2 diabetes, free of chronic complications who are non-smokers. The~     intervention is composed of four monthly visits followed by a continuous at-distance support~     system. At each visit, patients stay for six hours in the center. Information is presented in~     group sessions. Empowerment techniques are applied during individual exchanges with the team~     or during facilitated group sessions. In summary, empowerment programs are an unmet need in~     many healthcare services.~   "
55787|NCT02836795|"~     This is a mono-center, open-label, phase 1 study evaluating the humanized anti-PD-1 antibody~     JS001, as a monotherapy in patients with advanced melanoma or urological cancers who have~     failed in routine systemic treatment. The study will be conducted in 2 parts: dose escalation~     and cohort expansion to investigate tolerability and efficacy.~   "
55788|NCT02836782|"~     New markers of viral activity are now under investigation. Aim of the study is to investigate~     the efficacy of new antiretroviral drugs by monitoring HIV-DNA dynamics in HIV-positive~     population. In HIV/HCV coinfected population, the study of HIV reservoir dynamics and the~     analysis of the prevalence of HCV resistance-associated mutations will help clinicians to~     improve the management of coinfected patients.~   "
55789|NCT02836769|"~     Although evidence exists to support cancer rehabilitation, services are fragmented and~     rehabilitation professionals are consulted infrequently and often long after treatment ends,~     when chronicity of problems limits the impact of intervention. Therefore, the objective of~     this project is to develop, implement, and conduct a pilot evaluation of the Rehabilitation~     Consult (RC). The RC program goals are to increase knowledge about rehabilitation needs and~     resources to meet those needs; to establish individualized rehabilitation goals for HNC~     survivors and personalized action plans to meet those goals; and to provide support to HNC~     survivors for the implementation and evaluation of action plans. This project consisted of~     intervention development and pilot evaluation; this trial registration describes the pilot~     evaluation phase only.~   "
55790|NCT02836743|"~     To evaluate effect of slow-release melatonin (Circadin) on REM sleep behavior disorder.~   "
55800|NCT02836613|"~     The main purpose of this study is to evaluate how much galcanezumab gets into the body after~     it is given as an injection just under the skin by two different devices. This study will~     measure how much galcanezumab reaches the blood stream and will test how it affects~     calcitonin-gene related peptide (CGRP) in blood. Information about any side effects that may~     occur will be collected. The study will last about 20 weeks for each participant. Screening~     is required within 45 days prior to the start of the study.~   "
55801|NCT02836600|"~     The purpose of this study is to evaluate the tolerability of the study drug LY3039478 in~     Japanese participants with advanced solid tumors.~   "
56344|NCT02829463|"~     In this study, the investigators use the clinical documentation and imaging data of MRI to do~     research. Clinical subjects were divided into two groups: osteoarthritis patients and healthy~     controls without osteoarthritis. Differences of MRI data were studied between two groups.~   "
55791|NCT02836730|"~     The rate of success 12 months after surgery is reported to be 60-65% in patients with lumbar~     disc herniation and 60-70% in patients with spinal stenosis.~      At the Back Center Copenhagen, patients with persistent low back pain caused by lumbar disc~     herniation and spinal stenosis are treated by a multidisciplinary team comprising~     rheumatologists, physiotherapists, chiropractors, and social workers according to current~     guidelines. Therefore we have a unique opportunity to report the long term outcome in~     candidates for surgery, regardless of whether they have surgery or not, after having received~     optimal but unsuccessful nonsurgical treatment.~      The purpose of this study is to answer the following questions: 1) What is the proportion of~     patients operated upon after referral to surgical evaluation with positive MRI findings,~     persistent low back pain, and poor outcome following non-operative treatment? 2) What was the~     outcome in these patients 2 years following referral? 3) Where any baseline variables~     predictive of good or poor postsurgical outcome? 4) Where there any difference in outcome in~     patients with or without surgery?~   "
55792|NCT02836717|"~     The aim of this study is to determine the success rate, the success duration, the~     complication rate, maintenance effort and quality of life several years after sacral nerve~     modulation (SNM) treatment for constipation or stool incontinence.~   "
55793|NCT02836704|"~     Primary Objective:~      -To test the hypothesis that higher initial dose of basal insulin (0.3 U/kg) is non inferior~     to standard initial dose (0.2 U/kg) based on the percentage of patients with at least one~     episode of hypoglycemia (≤3.9 mmol/L or severe) during the 16 weeks of treatment in~     overweight and obese type 2 diabetic patients uncontrolled with oral anti-diabetes drugs~     (OADs).~      Secondary Objective:~        -  To evaluate the percentage of patients achieving glycated hemoglobin (HbA1c) <7%.~        -  To evaluate the percentage and accumulated percentage of patients achieving fasting~          plasma glucose (FPG) target (<5.6, <6.1, and <7.0 mmol/L).~        -  To assess the changes in HbA1c, FPG, and postprandial glucose (PPG).~        -  To evaluate the insulin doses change.~        -  To evaluate the weight change.~        -  To evaluate overall hypoglycemia, nocturnal hypoglycemia and severe hypoglycemia~          occurrence.~        -  To descriptively evaluate the safety profile.~        -  To assess patient and physician satisfaction and adherence (drop-out rate and the~          percentage of patients who can follow the treatment and insulin titration).~        -  Subgroup analysis on efficacy (control rate, control rate without confirmed~          hypoglycemia, and changes in HbA1c, FPG and PPG) and safety data according to:~        -  Age~        -  Duration of diabetes~        -  Baseline treatment (OAD)~        -  Baseline HbA1c, FPG and PP~   "
55794|NCT02836691|"~     The autonomic nervous system (ANS) plays an important role in asthma, primarily through the~     parasympathetic (by the cholinergic pathway) promoting bronchoconstriction. Asthma is a~     chronic inflammatory disease, however, bronchoconstriction is not always caused by bronchial~     inflammation, as occurs in paucigranulocitic phenotype or noninflammatory asthma. The~     hypothesis of this project is based on the activation of the parasympathetic nervous system~     (PNS) would be involved in the pathogenesis of noninflammatory asthma (paucigranulocitic~     phenotype) and emotional stress and poor control of patients with severe asthma. To determine~     the ANS involvement in the pathogenesis of paucigranulocItic phenotype in asthma and~     correlate emotional stress, mediated by the ANS, with uncontrolled severe asthma. 30~     asthmatics with different clinical severity (mild, severe controlled and uncontrolled severe)~     will be recruited , along with a control group of 10 healthy people. Descriptive variables,~     spirometry, inflammatory parameters (FeNO and inflammatory cell count in induced sputum),~     blood, saliva, urine and hair to obtain stress markers (glucose, copeptin, prolactin,~     cortisol) will be collected, and be supplied validated questionnaires of asthma control,~     quality of life and stress. For monitoring the response of the ANS will be done through an~     electrocardiogram, recording the heart rate variability (HRV). This analysis is carried out~     with the collaboration of engineers specialized in the characterization of cardiovascular~     signals for measuring the ANS.~   "
55795|NCT02836678|"~     The effect of adding Nanobone on horizontal bone gain in ridge splitting.~   "
55796|NCT02836665|"~     After admission to the emergency room each dermatological patient is routinely assessed to~     Manchester Triage System (MTS) by the nursing staff. Thereby data are collected for anamnesis~     followed by randomization in two equal study groups.~      Patients of group A (control group) wait routinely until the dermatological investigator in~     charge arrives at the emergency room. Once the dermatological investigator is on site, he~     gives a diagnosis and proposes a therapy.~      For Patients of group B (teledermatology) study-related photographs of the skin lesion and~     anamnesis data are uploaded to the hospital information system medico. Those data can~     directly be processed by the dermatological investigator in charge who enters his diagnosis~     and his therapy proposal.~      Subsequently an internal control is carried out as the same investigator comes personally to~     the emergency room to check its telemedical diagnosis and therapy proposal.~      Finally both time periods patients have to wait in the emergency room for their diagnosis and~     therapy are compared with each other.~   "
55797|NCT02836652|"~     This study is a prospective, multi-center, randomized, double-blind placebo-controlled study~     of subjects receiving the HM II LVAD as per the current FDA approved indications for use.~   "
55798|NCT02836639|"~     Phase II study for safety and efficacy of BEB (Bendamustine, Etoposide, Busulfan)~     conditioning regimen for ASCT in non-Hodgkin's lymphoma~   "
55799|NCT02836626|"~     Over 1.37 million Caesarian sections (C-sections) are performed annually in the US . It is~     estimated that 12-20 % of those will result in chronic scar pain. This pain can lead to~     functional difficulties performing activities of daily living, pain with bowel movements, and~     pain with sexual activity . There is anecdotal evidence supporting the use of deep fascial~     scar mobilization techniques in reducing abdominal surgical scar pain, and yet almost no~     research has been published. The aims of this randomized clinical trial will be to determine~     if deep fascial scar mobilization techniques or superficial scar mobilization techniques will~     improve chronic pain and its resulting functional deficits, threshold pressure discomfort,~     pressure tolerance and mobility restrictions resulting from C-section surgery and to see if~     these interventions are more effective than no intervention. A positive result may result in~     an increase in the use of this intervention and thus the reduction of chronic scar pain for~     many women; it may provide justification for insurance reimbursement for this approach and it~     will also pave the way for further investigation into the use of these techniques with other~     types of painful scars including hysterectomy.~   "
55802|NCT02836587|"~     Fall related injuries are major health problem which effect especially elderly population.~     After experiencing a fall, most of the elderly are unable to resume their previous mobility~     and the fear of future falls affects their daily life. Falls in elderly population are often~     related to balance or gait problems. The aim of this study is to assess the influence of~     balance training on postural and motor control of healthy elderly participants. The study is~     designed as a parallel interventional study with experimental and control group (allocation~     ratio 1:1). Participants' general health, balance abilities, fear of falling and gait~     stability and variability will be assessed on the baseline measurement, right after and 2~     months after the completion of the training programme. Experimental group will undergo~     training focused on development of balance abilities and strength twice a week (60 minutes in~     length each) for 8 weeks. Participants will receive individualized exercises which will be~     focused on the main 4 types - stance exercises, gait and transition exercises and strength~     exercises especially focused on muscle strength of lower extremities.~   "
55803|NCT02836574|"~     The purpose of the present study is to compare the safety and efficacy of up to 2 injections~     of NKA given 3 to 6 months apart (maximum) in subjects who are randomized to receive their~     first treatment as soon as the NKA product is made available versus subjects who are~     randomized to undergo contemporaneous, standard-of-care treatment for CKD during the first 12~     18 months prior to receiving up to 2 injections of NKA.~   "
55804|NCT02836561|"~     The goal of this project is to investigate whether a pre-visit telephone intervention could~     increase awareness of long-acting reversible contraception (LARC) availability at the time of~     uterine evacuation.~   "
55805|NCT02836548|"~     This is a mono-center open-label proof-of-concept pharmacologic study to explore the efficacy~     and safety of vorinostat in advanced BRAF mutated melanoma, which became resistant for~     BRAF-inhibitors or the combination of BRAF- and MEK-inhibitors.~   "
55806|NCT02836535|"~     The purpose of this study is to understand the patient experience with an adverse event after~     surgery. An adverse event is an undesirable experience or complication associated with your~     surgery.~   "
55807|NCT02836522|"~     The purpose of this study is to finalize development of a questionnaire that measures~     health-related symptoms and concerns for persons diagnosed with, and either treated or~     monitored for, anal pre-cancer lesions.~   "
55808|NCT02836509|"~     Currently, Paracetamol and Ibuprofen are widely used by emergency physicians in Turkey for~     the pain treatments.~      The objective of the study was to assess whether intravenous Paracetamol has superior Low~     Back Pain reduction will compare with Ibuprofen in emergency department (ED) adults.~      Half of the participants will receive Paracetamol and the other half will receive Ibuprofen.~   "
55809|NCT02836496|"~     Mepolizumab is a humanized monoclonal antibody. In conditions where eosinophilia is~     considered to play an important part in the pathology, including eosinophilic asthma, HES,~     and eosinophilic granulomatosis with polyangiitis, a consistent reduction in blood eosinophil~     counts is observed in association with mepolizumab administration, with concomitant clinical~     improvement. This is a 32-week treatment period, randomized, double-blind,~     placebo-controlled, parallel group, multicentre study of mepolizumab in adolescent and adult~     subjects with severe HES receiving standard of care (SoC) therapy. This study will~     demonstrate the efficacy of mepolizumab compared with placebo based on maintenance of control~     of HES symptoms during the treatment period. The study will comprise of a screening period of~     up to approximately 4 weeks followed by a 32-Week study treatment period (subjects will be~     randomized 1:1 to placebo or mepolizumab) and up to 8-week additional follow-up period (12~     weeks after the last dose of study treatment).~   "
55810|NCT02836483|"~     A Prospective, Randomized, Open, Active-controlled, Interventional, Exploratory, Phase II~     Trial of LCB01-0371.~   "
55811|NCT02836470|"~     The purpose of this study is to establish preliminary evidence of the efficacy, safety, and~     tolerability of LB1148 for the treatment of post-operative ileus and intra-abdominal~     adhesions in subjects undergoing elective bowel resection.~   "
55812|NCT02836457|"~     The primary objectives of this study is to estimate the real-world safety profile of Eliquis~     in Japanese Venous Thromboembolism patients and to estimate the risk factors likely to affect~     the incidence of bleeding. Lastly, the secondary objective of this study is to estimate the~     real-world effectiveness profile of Eliquis in Japanese Venous Thromboembolism patients.~   "
55813|NCT02836444|"~     Current definitions of the Acute Respiratory Distress Syndrome (ARDS) could be adequate for~     epidemiological studies but are not adequate for inclusion of patients into therapeutic~     clinical trials. It is a matter of debate whether the assessment of hypoxemia at ARDS onset~     is appropriate for stratifying lung severity and risk of death in ARDS patients. The~     investigators will perform an observational, non-interventional, multicenter, prospective~     audit in a network of intensive care units in Spain for evaluating the severity and risk of~     death based on the assessment of respiratory and ventilatory function at 24 hours after ARDS~     diagnosis under standardized ventilatory conditions. This study is the confirmatory phase of~     the study NCT02288949.~   "
55814|NCT02836431|"~     This research study is examining the absorption of the sedative dexmedetomidine (DEX) in the~     blood when given by nasal spray. The study will help us determine the best dosing amount for~     children undergoing sedation or anesthesia with DEX.~   "
55815|NCT02836418|"~     ATYR1940-C-006 is a multi-national, multicenter study being conducted at centers in the~     United States (US) and Europe who participated in the Study ATYR1940-C-003 (Stage 1 only) or~     ATYR1940-C-004 (i.e., the parent studies).~   "
55816|NCT02836405|"~     The main purpose is to study brain plasticity (the changes that occur in the brain through~     experience) in individuals with autism spectrum disorder (ASD). Research suggests that during~     development, the brains of individuals with ASD may change in response to their experiences~     differently than the brains of typically developing individuals. Investigators want to~     understand why and how this difference may contribute to the symptoms of ASD.~   "
55863|NCT02835794|"~     The purpose of this study is to determine the safety and establish the maximum tolerated dose~     (MTD) of omacetaxine in combination with azacitidine and G-CSF in patients with relapsed~     and/or refractory MDS.~   "
56345|NCT02829450|"~     The purpose of this study is to determine whether the treatment of peritoneal ultrafiltration~     can improve survival and quality of life of refractory congestive heart failure with special~     accent on preserving residual renal function and peritoneal membrane characteristics/~   "
55817|NCT02836392|"~     This is a translational, multicentre questionnaire study. The study design follows that of a~     cross sectional, quantitative research approach. Data collection will involve~     self-administered, paper-based questionnaires. The method of data collection allows for a~     large sample size without major expense. The questionnaires are comprised of several~     questions examining areas such as demographic details, cancer diagnosis, understanding of the~     term 'clinical trials', attitudes to personal participation in cancer clinical research and~     the experience of patients who previously participated in a cancer clinical trial. The study~     will be opened in all interested hospitals in Ireland following initiation of the study at~     each site. Questionnaire completion will be seen as implied informed consent and no formal~     consent will need to be signed by the patient. The paper-based questionnaire responses will~     be electronically and anonymously recorded in a computer database to facilitate analysis.~   "
55818|NCT02836379|"~     In the context of radiotherapy, control of breakthrough pain represents a special challenge.~     Patients undergoing radiotherapy may experience different situations of pain that may be due~     to the need to remain immobilized during radiotherapy session, the need to wear an~     immobilization mask (head and neck cancer), the odynophagia caused by mucositis, defecation~     after the development of proctitis, or sudden pain during the night causing sleep~     disturbances.~      In a survey conducted in radiation oncology services more than half of patients treated with~     radiotherapy experienced pain, and 39% of patients reported that their pain was not treated~     properly. This situation may increase the patient's anxiety, dissatisfaction with treatment,~     affect their quality of life and can even come to refuse radiotherapy treatment.~      This post-authorization observational study will assess the quality of life of cancer~     patients with breakthrough cancer pain treated in radiotherapy services in Spanish hospitals.~   "
55819|NCT02836366|"~     With this study results of the Targon® PH+ nail, developed for the treatment of humeral head~     fractures, will be investigated clinically, radiological evaluation is optional. The primary~     objective of this study is to examine the effect of a plating treatment on the speed of~     recovery of functional capacity in adult patients. Secondary aims are to examine the level of~     pain, patient satisfaction, shoulder function, quality of life, radiological evaluation and~     complications.~      Targon PH+ is CE certified. The study is a non-interventional cohort study sponsored by~     Aesculap~   "
55820|NCT02836353|"~     Surgery on the gastrointestinal (GI) tract results in profound changes to the metabolic~     profile. This is well described, including the rapid resolution of diabetes seen after~     bariatric surgery. The underlying pathophysiology, and incidence in lean patients undergoing~     surgery for cancer, is somewhat less described. The investigators plan to assess the~     symptomatic and glycaemic profile, as well as causative pathways, for metabolic symptoms in~     patients after surgery on the GI tract. The investigators will use glucose tolerance tests,~     physiological challenges with somatostatin analogues and antibiotics, and assess tissue~     transcriptomic changes.~   "
55821|NCT02836340|"~     Following successful cardiopulmonary resuscitation (CPR) after out of hospital cardiac arrest~     (OHCA), 50% of patients admitted to the Intensive Care Unit (ICU) die. As most patients die~     due to brain damage sustained during cardiac arrest and the subsequent reperfusion phase,~     effective neuroprotective strategies could potentially improve outcome. In animal~     experiments, 2-Iminobiotin (2-IB), a selective neuronal and inducible nitric oxide synthase~     (NOS) inhibitor, given upon reperfusion has been shown to improve memory function. Since 2-IB~     has not shown any safety issues in preclinical and clinical studies. Before embarking on~     large studies with efficacy as primary endpoint, safety, tolerability and pharmacokinetics~     need to be established.~      Objective: Evaluate short term safety and tolerability, and the pharmacokinetic properties of~     2-IB in adult patients after OHCA.~      Study design: Phase 2, single-centre, open-label, dose-escalation intervention study.~      Study population: Three cohorts of eight evaluable patients admitted to the ICU after OHCA~     due to a cardiac cause.~      Intervention:~      The first eight patients will receive 0,055 mg/kg 2-IB every 4 hours intravenously, 6 times~     in total (part A). The second eight patients (cohort B) will receive 0,165 mg/kg every 4h iv,~     6 times in total. The third eight patients (cohort C) will receive 0,5 mg/kg every 4h iv, 6~     times in total. Medication has to be given as soon as possible and within 6h after OHCA.~     Escalation to the next dose level will only be done after pharmacokinetic analyses have~     performed, no relevant safety issues have been encountered, and the DSMB approves to move to~     the next dose level.~      Main study parameters/endpoints:~      Study parameters to evaluate short term safety and tolerability will be vital signs (heart~     frequency, blood pressure, cardiac ischemia) before and until 15 minutes after~     administration. (Serious) Adverse Events will be recorded on the ICU (up to 7 days) or until~     discharge from the ICU. For evaluation of the pharmacokinetics profile of 2-IB, 9 plasma~     samples will be analysed. Secondary parameters: Biochemical markers Neuron specific Enolase~     and s100b at 24h and 48h after start of study drug, occurrence of SAEs until 30 days after~     OHCA including death, long term term efficacy as determined by the Cerebral Performance~     Category (CPC), the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) or~     the Telephone Interview Cognitive Status (TICS) scale at 30 days after OHCA.~   "
55822|NCT02836327|"~     To investigate multimodel MRI exploring the pathophysiology of multiple sclerosis and~     neuromyelitis optica spectrum disorders.~      The investigators use multimodel MRI to evaluate the extent of blood-brain barrier and white~     matter fiber tracts destruction , iron deposition and cerebral blood flow of associated~     regions in multiple sclerosis and neuromyelitis optica spectrum disorders using~     contrast-enhanced magnetic resonance imaging , quantitative susceptibility mapping, diffusion~     tension imaging, and arterial spin labeling with post labeling delay of 2.0 seconds. Transfer~     constant volume , magnetic susceptibility, cerebral blood flow and fractional anisotropy(FA)~     value were measured in lesion and normal appearing white matter.~   "
55823|NCT02836314|"~     The aim of this split mouth, single-center, controlled study is to compare the healing of~     intrabony defects treated with a combination of Anorganic Bovine Bone Mineral (ABBM)/Platelet~     Rich Fibrin (PRF) or Anorganic Bovine Bone Mineral alone. The hypothesis being tested in the~     study was that PRF would augment the regenerative effects of ABBM in human intrabony defects.~   "
55824|NCT02836301|"~     Investigators will evaluate organ donation educational videos with a 2x3 single blinded~     Randomized Control Trial (RCT) in partnership with our 26 Latino Owned Barbershops (LOBs).~     The testimonial video about Uncontrolled Donation after Circulatory Determination of Death~     (uDCDD) with an uplifting ending will serve as control. Experimental videos may include live~     uDCDD footage, differing endings, or combinations. Video production will be informed by the~     entertainment education model and produced with experts including an Academy Award winning~     filmmaker. The primary outcome is whether participants immediately enroll in the NY State~     Organ Donor Registry (either online or by our RA mailing in the official form with prepaid~     postage). Investigators hypothesize that each video will induce differences in registration~     compared to the control and that there is an interaction effect with video genre and story~     outcome.~   "
56346|NCT02829437|"~     Observational, retrospective and prospective study on Endometrial Stromal Tumor (EST)~   "
55825|NCT02836288|"~     The primary purpose of this study is to see if it is safe to give patients with cancer a low~     dose of the FDA approved anesthetic drug ketamine at the same time they receive radiation,~     chemotherapy, and/or surgery for their cancer treatment to treat depression and its effects.~     Researchers would also like to see if giving ketamine at the same time as cancer treatment is~     practical and reasonably acceptable to the patient.~      Depression has many negative consequences for outcomes in those with cancer. It causes~     delayed treatments, increases in hospital lengths of stay, decreases in treatment adherence,~     poorer self-care, and decreased quality of life, even at 3 years post treatment. The presence~     of depression is the number one predictor of incomplete treatment and difficulty with~     rehabilitation. Therefore, investigators would also like to see if it is feasible to give~     patients ketamine during their routine cancer treatment treat depression and its negative~     effects on cancer treatment outcomes, and also help with anxiety, pain, and quality of life.~     The study will also use a placebo to compare to the good and/or bad effects of ketamine. A~     placebo is not an active drug and it will be look the same as ketamine, as a liquid to be~     taken by mouth.~      Ketamine is approved by the U.S. Food and Drug Administration (FDA) as a general anesthetic~     by itself for some diagnostic and surgical procedures or combined with other general~     anesthetic agents. It has also been shown to reduce cancer pain. Ketamine is considered~     experimental in this study because it is not approved by the FDA for the treatment of~     depression.~   "
55826|NCT02836275|"~     Gynecological ultrasound is well known as the preferred exam to assess patients with ovarian~     tumors. The International Ovarian Tumor Analysis (IOTA) group developed the 'Simple Rules' to~     classify an ovarian tumor as benign or malignant. In about 1/5 of patients the Simple Rules~     give an inconclusive result and therefore a suitable second line test is necessary. Recently~     the ADNEXMR SCORING system was developed, this is the first Magnetic Resonance Imaging (MRI)~     score system that focuses on ovarian tumors.~      The aim of this prospective study is to evaluate the performance of pelvic MRI examination~     with perfusion -and diffusion- weighted sequences and the application of the ADNEXMR SCORING~     system in ovarian tumors that cannot be classified by the IOTA Simple Rules (regarding the~     prediction of malignancy). Other aims are the determination of the malignancy rate per~     ADNEXMR SCORING system class, the evaluation of interobserver reproducibility and the~     assessment of the accuracy of the specific diagnosis based on MRI images.~      The study is a multicenter prospective study. In centers where perfusion -and diffusion~     weighted MRI imaging is not a part of clinical routine in unclassifiable ovarian masses based~     on ultrasound, the study is considered to be interventional. However, in other centres,~     depending on the local guidelines, perfusion -and diffusion weighted MRI imaging can be~     standard of care. In these centres, the study can be considered to be observational.~      The IOTA-MRI project is linked to the IOTA study. In this multicenter study different~     diagnostic ultrasound algorithms are tested prospectively in patients with an ovarian mass~     prior to surgery. This study allows to define a subgroup of patients in which Simple Rules~     are inconclusive, in other words the population eligible for inclusion in the IOTA-MRI~     project. We plan to include 250 patients in the IOTA-MRI study. Patients will be included~     consecutively, yet only after completing the informed consent. Recruitment will take 2 years~     of time as of the start of the individual center.~      The gold standard is the histopathology diagnosis of the mass within 120 days after~     ultrasound evaluation. The surgical approach is chosen by the managing clinician.~   "
55827|NCT02836262|"~     To evaluate effectiveness and safety of HHRS in subjects undergoing total hip arthroplasty~     (THA). Effectiveness will be evaluated using patient-reported, clinical, radiologic, and~     radiostereometric outcomes. Safety will be evaluated through the collection of device-related~     and unanticipated device-related adverse events.~   "
55828|NCT02836249|"~     The primary objective of this study is to compare the efficacy, safety, and tolerability of~     tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive and~     treatment-experienced adults with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B~     virus (HBV) infection in China.~   "
55829|NCT02836236|"~     The primary objective of this study is to compare the efficacy, safety, and tolerability of~     tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive and~     treatment-experienced adults with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B~     virus (HBV) infection in China.~   "
55830|NCT02836223|"~     This study evaluates the addition of an interdental cleaning device paired with a manual~     toothbrush compared to using a manual toothbrush only. Plaque removal, reduction of gingival~     bleeding and reduction of gingival inflammation.~   "
55831|NCT02836210|"~     To prospectively compare clinical outcomes using straight (perpendicular) versus angled~     trocar insertion during 27 gauge pars plana vitrectomy surgery for epiretinal membrane~      Primary Endpoints:~      Sclerotomy suture rates and incidence of suture blebs at the end of 27 gauge MIVS.~      Secondary Endpoints:~      Rate of postoperative wound-related complications such as hypotony, choroidal detachments,~     endophthalmitis, and sclerotomy-related retinal tears with a minimum follow-up of 30 days.~   "
55832|NCT02836197|"~     Background: Although previous studies have reported the efficacy of communication skills~     training programs (CST), specific training addressing communication about uncertainty and~     hope in oncology has not yet been studied. This paper describes the study protocol of a~     randomized controlled trial assessing the efficacy of a CST program aimed at improving~     physician ability to communicate about uncertainty and hope in encounters with cancer~     patients.~      Methods: Physician participants will be randomly assigned in groups (n = 3/group) to a~     30-hour CST program (experimental group) or to a waiting list (control group). The training~     program will include learner-centered, skills-focused, practice-oriented techniques. Training~     efficacy is assessed in the context of an encounter with a simulated advanced stage cancer~     patient at baseline and after the CST for the experimental group, and after four months for~     the waiting-list group. Efficacy assessments will include communicational, psychological and~     physiological measures. Group-by-time effects will be analyzed using a generalized estimating~     equation (GEE). A power analysis indicated that a sample size of 60 (30 experimental and 30~     control) participants will be sufficient to detect effects.~      Discussion: The current study will aid in the development of effective CST programs to~     improve physician ability to communicate about uncertainty and hope in encounters with cancer~     patients.~   "
55833|NCT02836184|"~     With calcium carbonate as the positive control drug, to observe the effectiveness and safety~     of nicotinic acid in hemodialysis patients with hyperphosphatemia~   "
55834|NCT02836171|"~     he primary purpose of this study is to investigate potential pharmacokinetic interaction in~     healthy volunteers when apatinib is administered in combination with itraconazole. Secondary~     objective is evaluating the safety and tolerability of apatinib alone and when~     co-administered with itraconazole.~   "
55835|NCT02836158|"~     This study suggests that R-IDARAM combined with intrathecal immunochemotherapy may be high~     effective in elderly patients with primary central nervous system lymphoma (PCNSL).~   "
56360|NCT02829255|"~     Prospective interventional trial in lowlanders evaluating the effect of acute exposure,~     acclimatization and re-exposure to high altitude on cerebral autoregulation~   "
55836|NCT02836145|"~     Female urinary incontinence and pelvic organ prolapse are common diseases especially in aged~     women that frequently cause urogenital infection, voiding difficulty, urinary retention,~     pelvic pain, constipation, and coital difficulty, as well as impact the quality of life of~     women. Risk factors of the above diseases include pregnancy, vaginal delivery, and menopausal~     status. Despite playing a crucial role in the pathophysiology of the above diseases, the~     urogenital skeletal muscular dysfunction cannot be fully corrected via the current treatment~     modalities.~      The human induced pluripotent stem cells (hiPSCs) represent a prime candidate cell type for~     current research and future cell therapy because of their significant self-renewal,~     differentiation potential and the relative lack of ethical conflict. With the advent of~     efficient technology of reprogramming peripheral blood mononuclear cells (PBMCs) into hiPSCs,~     researchers can generate personalized lines of cells from which it will be possible to obtain~     differentiated cells in a less invasive way, introducing opportunities in treating diseases~     that are now considered incurable.~      Until very recently, little success has been achieved in terms of skeletal muscle~     differentiation from hiPSCs. The purpose of this study is to explore the applicability of the~     differentiation into skeletal muscle progenitor cells from hiPSC cell lines and the~     associated biomolecular messages. It is anticipated that the derived skeletal muscle~     progenitor cells can be reprogrammed from PBMCs of female patients with urinary incontinence~     and/or pelvic organ prolapse and used in preclinical testing for relieving female urogenital~     problems.~   "
55837|NCT02836132|"~     The aim of this Phase II Small Business Technology Transfer grant is to complete development~     of a virtual reality intervention to augment and improve commercial Internet-delivered~     behavioral weight loss treatments, and to test it in a randomized controlled trial.~   "
55838|NCT02836119|"~     The overarching study aim is to evaluate the development of sleep behavior and gut microbiota~     (GMB), and their potential interaction, during the vulnerable period of the first year of~     life. Age-specific fecal profiles with bacterial genome sequencing will provide new insight~     into the functional coevolution of the GMB and host sleep behavior.~   "
55839|NCT02836106|"~     The aim of this project is to elucidate how high-fat meals with different kinds of dairy~     products affect postprandial responses of lipid metabolism and inflammatory markers in~     healthy and obese subjects.~   "
55840|NCT02836093|"~     Many patients receiving radiation therapy for breast cancer experience fatigue although~     doctors do not fully understand why. The purpose of this study is to test if patients who~     experience fatigue during radiation treatment for breast cancer have changes in their~     capability to perform exercise on a treadmill.~   "
55841|NCT02836080|"~     Among youth, the prevalence of mental health and addiction (MHA) disorders is roughly 20%,~     yet youth are challenged to access services in a timely fashion. To address MHA system gaps,~     this study will test the benefits of an Integrated Collaborative Care Team (ICCT) model for~     at-risk youth with MHA challenges. In partnership with community agencies, adolescent~     psychiatry hospital departments, and family health teams, investigators have developed an~     innovative model of service provision involving rapid access to MHA services. This model will~     be implemented and compared to the usual treatment youth receive in hospital-based,~     outpatient, mental health clinics in Toronto. A rapid, systematic, approach to MHA services~     geared to need in a youth-friendly environment is expected to result in better MHA outcomes~     for youth. Moreover, the ICCT approach is expected to decrease service wait-times, be more~     youth- and family-centred, and be more cost-effective.~   "
55842|NCT02836067|"~     The purpose of this study is to learn how smoking affects the immune systems in people with~     HIV infection. The investigators would like to know if HIV infected smokers who quit smoking~     have different responses in their tissues from people who keep smoking.~   "
55843|NCT02836054|"~     Analysis of 4 CSF Alzheimer's disease biomarkers (total and phosphorylated tau protein, Aß40~     and Aß1-42) and morphological brain MRI in older patients (>60 year's old) with bipolar~     disorder, after an evaluation of their cognitive functions.~      Comparison between two groups of patients : patients with cognitive disorders and patients~     without cognitive disorders.~      The objective is to describe and compare the profile of those biomarkers in those two~     populations.~   "
55844|NCT02836041|"~     The investigators want to better understand how children sleep at night at MSKCC, so that the~     investigators can learn how to improve the sleeping environment.~   "
55845|NCT02836028|"~     The purpose of this phase 2, multiple-cohort, randomized, open-label, international study of~     talazoparib (a poly (ADP-ribose) polymerase (PARP) inhibitor) is to compare the efficacy and~     safety of talazoparib monotherapy and talazoparib plus temozolomide in women with relapsed~     ovarian, fallopian tube, and peritoneal cancer.~   "
55846|NCT02836015|"~     The investigators seek to apply a shared medical visit model and interdisciplinary approach~     to Spanish-speaking patients. The investigators will evaluate the patient's hemoglobin A1c as~     a marker of glycemic control and evaluate their mood with PHQ screening tools. The~     investigators seek to improve diabetes care for this group of underserved patients. Potential~     participants will be selected from the UNMC diabetes registry. Eligibility criteria includes~     adult patients over the age of eighteen years old with Type 2 diabetes, HgbA1c greater than~     8%, whose preferred language is Spanish. Exclusion criteria include pregnancy, residency at a~     nursing home or other facility, substance abuse, and physician recommendation that study is~     not appropriate for the patient.~   "
55847|NCT02836002|"~     This is a single-center, open label study. The primary aim of this project is to develop a~     controlled human malaria infection transmission model (CHMI-trans) or challenge model to~     evaluate the capacity of vaccines, biologics (monoclonal antibodies, or mAbs), and drugs to~     block malaria parasite transmission by assessing infectiousness of Plasmodium falciparum (Pf)~     gametocyte carriers for Anopheles mosquitoes.~   "
55864|NCT02835781|"~     Allogenic acellular dermal matrix has been used in burn injuries or abdominal walls~     reconstructions. However, it is solely used in breast reconstructions after breast carcinoma~     amputation. The efficacy of such allogenic dermal matrix can be advantageous when compared to~     current treatment options, however, this has to be proved.~   "
55932|NCT02834884|"~     SPECTA is a program aiming at establishing a quality assured platform for collecting~     clinicopathologically annotated biological material, imaging data, as well as~     patient-reported outcomes from cancer patients to support biospecimen-based translational~     research and biomarker discovery to improve the understanding of tumor biology and cancer~     patients care.~   "
55848|NCT02835989|"~     Community Paramedicine @Home (CP@Home) is a novel community paramedicine health assessment~     program for high users of Emergency Medical Services (EMS). Individuals who have been~     identified as active callers to EMS, individuals who have called EMS for lift-assists, and~     direct paramedic referrals are referred into the community paramedicine home visit program.~     The program will focus on in-home chronic disease management, community health service~     connections, and EMS usage education. Aside from chronic disease management, aspects of the~     program include health-related quality of life, social isolation and other social~     determinants of health. Participants in the program will have up to 3 one-on-one home visits~     from a community paramedic to ultimately reduce repeat EMS calls and improve their overall~     health.~   "
55849|NCT02835976|"~     This Phase I study is designed to determine the excretion balance of radiocarbon, as the sum~     of carbon-14 (14C)-labeled TRO19622 and its 14C-metabolites, and to investigate the~     pharmacokinetics and metabolic profile of TRO19622 (olesoxime) in healthy participants.~   "
55850|NCT02835963|"~     No studies have analyzed the predictive value of different anamnestic and clinical signs for~     the diagnosis of acute heart failure (AHF) in patients admitted to emergency department.~     That's why the expert group of the AHF of South West of France mobilizes to conduct this~     study to evaluate the diagnostic predictive value of different anamnestic and clinical signs~     for the diagnosis of AHF to emergencies.~   "
55851|NCT02835950|"~     The objective of this study is to assess the safety, performance and initial effectiveness of~     the TIVUS™ System when used for pulmonary artery denervation through subjective and objective~     change in clinical parameters and haemodynamic evaluation. This is a prospective,~     multi-center, non-randomized, open-label clinical trail. The study will be conducted in up to~     4 centers and will recruit up to 15 patients diagnosed with PAH, functional class III who~     have stable PAH on a stable drug regimen of two pulmonary arterial hypertension specific~     medications.~   "
55852|NCT02835937|"~     Do ambulatory RBC transfusions improve home functional status?~   "
55853|NCT02835924|"~     The purpose of this study is to assess the safety and tolerability of different~     dose-escalation approaches of regorafenib in mCRC patients.~   "
55854|NCT02835911|"~     This registry study is intended to establish a large prospective longitudinal clinical cohort~     of lymphoma patients in Malawi, as such data is currently lacking from sub-Saharan Africa.~     The investigators will perform core biopsies on at least 800 consecutively enrolled patients~     with suspected lymphoma for accurate histopathologic characterization. The investigators will~     systematically collect relevant clinical and laboratory data, and longitudinally follow those~     with confirmed hematologic malignancies receiving treatment according to local standards of~     care to assess outcomes.~   "
55855|NCT02835898|"~     Objective: The aim of this pilot study is to evaluate the alterations of epigenetic patterns~     in periodontally diseased individuals, before and after periodontal treatment, also in~     comparison to periodontally healthy patients.~      Materials & methods: Twenty patients were voluntarily enrolled in two groups: 10 participants~     with healthy periodontium, and 10 participants with chronic periodontitis. Clinical~     parameters were recorded and gingival biopsies were collected within the following timelines:~     At baseline (for both groups), after 15 days (for the diseased group only) and after two~     months (for the diseased group only).~   "
55856|NCT02835885|"~     The purpose of this study is to determine the feasibility and safety of Transcutaneous Vagus~     Nerve Stimulation (tVNS) in healthy controls. Tested in healthy subjects (HS) the~     physiological effects of tVNS at different stimulation parameters. The electrical stimulation~     variables will be pulse width, frequency, and current. This will be tested in a laboratory~     setting and will measure tVNS effects on heart rate, respiration rate, blood pressure, and~     perceived pain. This is a feasibility and small safety study.~      Hypothesis: tVNS is feasible and safe~   "
55857|NCT02835872|"~     There is a need to assess the LDL-C-lowering abilities of a dietary fiber ingredient, in~     order to confirm the product's efficacy. Thus, the objective of this study is to assess the~     effect of 3g dietary fiber on lowering serum LDL-C in otherwise healthy men and women.~   "
55858|NCT02835859|"~     The purpose of this study is to collect data that will help researchers better understand the~     various causes of obesity and diabetes; particularly to understand how consumption of NCASs~     affects the way the body uses nutrients.~   "
55859|NCT02835846|"~     This purpose of this study is to understand the types of bacteria that are in the bladder and~     vagina in patients with overactive bladder (OAB) symptoms and understand if the types of~     bacteria change when with the use of estrogen in the vagina. The investigators are also~     trying to understand how estrogen influences the body's ability to make substances called~     peptides that can kill bacteria.~   "
55860|NCT02835833|"~     Angiogenesis, the development of new blood vessels, plays an important role in the disease~     development and tumor growth in many solid organ malignancies. Bevacizumab was the first~     anti-angiogenic drug to be approved in solid tumors and has shown advantageous activity with~     multiple tumor types. However, the responses from Bevacizumab are often transient due to the~     tumor's manipulative abilities to circumvent the usual pathways to find salvage pathways~     instead.~      Nintedanib has demonstrated anti-tumor activity in non-squamous non-small cell lung cancer,~     colorectal cancer, ovarian cancer, and renal cell cancer. The combination of Bevacizumab and~     Nintedanib are being proposed to target the tumor's manipulation processes to generate~     alternate pathways for angiogenesis thus creating a potential benefit to delay tumor growth.~   "
55861|NCT02835820|"~     Randomized control pilot 12 week feeding trial to compare the preliminary effects of~     ketogenic diet (versus patient choice diet) on HIV-associated neurocognitive impairment. N =~     20 (n = 10/10) randomized to diet condition. Pilot data necessary to evaluate the feasibility~     and determine initial data for primary outcomes in order to accurately determine needed~     sample size for larger clinical trial.~      Outcomes: 1) cognition (NIH Toolkit), 2) cardiometabolic markers (insulin glucose, insulin~     resistance, markers of inflammation), and 3) neural activity (as determined by functional~     MRI..~   "
55862|NCT02835807|"~     A sample of mothers in Tennessee are recruited to a group-randomized pretest-posttest~     controlled trial evaluating the effect of a social media campaign to decrease mothers'~     permissiveness for daughters to indoor tan. The primary outcomes is mothers' permissiveness~     for indoor tanning by daughters. Secondary outcomes are mother's indoor tanning prevalence~     and their support for stricter bans on indoor tanning by minors.~   "
55865|NCT02835768|"~     Background: Provision of anticipatory guidance to parents is recommended as an effective~     strategy to prevent injuries among young children. Internet-based anticipatory guidance is~     suggested to reinforce the effectiveness of injury prevention, and improve parents' knowledge~     on child safety. Parents receiving the guidance can reduce children's exposure to injury risk~     by adopting better childcare practices and using appropriate child safety devices at home.~      Objective: This study will examine the effectiveness of Internet-based injury prevention~     program with parental anticipatory guidance in enhancing mothers' knowledge on child safety.~     It aims at increasing mothers' knowledge and motivation of learning about domestic injury~     prevention through a new Internet-based intervention model. It also targets to improve~     mothers' attitude and perceived behavioral control of domestic safety practice.~      Methods: The study would adopt a randomized controlled trial design and recruit 934 mothers~     from the antenatal clinics and postnatal wards of two major public hospitals in Hong Kong.~     Participating mothers will be randomized into the intervention or control group with equal~     likelihood. Mothers in intervention group will be provided with free access to an~     Internet-based injury prevention program with anticipatory guideline whereas those in the~     control group will receive relevant parenting booklet.~      Results: It is hypothesized that mothers' general and age-appropriate knowledge on child~     safety and motivation of learning about domestic injury prevention as the primary outcome~     measures will be enhanced.~      Conclusions: The Internet is increasingly recognized as a practical and cost-effective~     platform for health education and safety information delivery. The goals of this study are to~     examine the effectiveness of a new Internet-based intervention program for improving mothers'~     knowledge, and raising mothers' awareness about the importance and consequences caused by~     domestic injuries.~   "
55866|NCT02835755|"~     This pilot trial studies how well a mobile health (mHealth) human papillomavirus (HPV)~     vaccine intervention works in increasing HPV vaccine coverage among young adult gay and~     bisexual men. Giving young men information about the HPV vaccine and the importance of~     vaccination may encourage them to get the HPV vaccine.~   "
55867|NCT02835742|"~     Objective: Determine the safety and efficacy of GM-CSF inhalation in patients with aPAP.~      Study Design: multi-center, randomized, double-blind, placebo- controlled, safety/efficacy~     study.~   "
55868|NCT02835729|"~     The purpose of this study is to characterize the regimen limiting toxicities (RLT) and~     recommended Phase 2 dose (RP2D) of indoximod in patients with newly diagnosed AML receiving~     remission induction chemotherapy with cytarabine and idarubicin.~      Safety and tolerability of Indoximod will also be evaluated at the RP2D in combination with~     standard-of-care (SOC) chemotherapy (defined as induction therapy with idarubicin and~     cytarabine and consolidation with high-dose cytarabine (HiDAC) in this trial) followed by~     single agent indoximod maintenance therapy in patients with newly diagnosed AML as compared~     to safety and tolerability of SOC chemotherapy alone.~   "
55869|NCT02835716|"~     This Observational protocol will attempt to verify two recent and very critical concepts in~     ALZ Clinical Research by studying high-risk individuals who already are taking medications~     which may prevent the onset of ALZ.~        -  It may be possible to determine the future development of ALZ in a preclinical state in~          a cognitively normal but high risk individual at least 18-24 months before any symptoms~          develop of cognitive impairment.~        -  Early treatment of these cognitively normal high-risk persons with subclinical pre-ALZ~          can prevent of delay the occurrence and severity of ALZ.~      Caveats~      Neither this protocol nor the fMRI imaging are designed or intended to diagnose or treat ALZ,~     nor develop or use medications or diagnostic neuroimaging outside of already approved and~     accepted parameters. Persons who volunteer to be study subjects in this observational~     protocol will be under the care of their primary care / specialty physician, who will order~     tests and treatments as they see appropriate.~      Although there is a very large body of peer-reviewed scientific literature demonstrating that~     certain functional MRI patterns are associated with certain neurologic conditions, the~     utilization of fMRI for the evaluation of neurologic disorders is still considered an~     emerging science and therefore in the investigational stage. Although this protocol will~     report on brain patterns of certain neurologic conditions such as cognitive impairment and~     Alzheimer's disease, based on patterns published in peer-reviewed journals, such findings are~     not considered stand alone or diagnostic per se and should always be considered by the PMD in~     conjunction with the patient's clinical condition. These data should only be used as~     additional information to add to the PMD's diagnostic impression.~   "
55870|NCT02835703|"~     The purpose of this study is to evaluate safety and efficacy of three main perfusion methods~     in surgical repair of coarctation of aorta with aortic arch hypoplasia in infants.~   "
55871|NCT02835690|"~     The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and~     efficacy of three doses of pembrolizumab (MK-3475) in adult Chinese participants with locally~     advanced or metastatic non-small-cell lung cancer (NSCLC).~      Cycle 1 is 28 days long; subsequent cycles are 21 days long.~   "
55872|NCT02835677|"~     With loss of mobility in multiple sclerosis (MS) comes an increase in amount and types of~     caregiver assistance, with a concomitant increase in burden for the caregiver. In fact,~     effect on caregiver burden can be seen as a potential indicator of the efficacy of MS~     management, suggesting that the caregiver is an appropriate and independent target for MS~     therapeutic strategies.~      MS patients report difficulty implementing and continuing with home exercise, mobility, and~     walking programs. This feasibility study will test integration of a successful behavioral~     caregiving intervention into clinical practice to improve functioning of Veterans with~     multiple sclerosis (MS) and their Caregivers. Caregivers of Veterans with MS will receive a~     behavioral caregiver intervention designed to address caregiver coping and management of~     patient concerns, with special focus on patient mobility and walking. A pre-post intervention~     design will compare outcomes for Veterans and Caregivers.~      For Veterans, the intervention will target Caregiver participation in home-based Veteran~     mobility activities. MS Caregivers report high burden, stress, and depression involved in~     caring for their loved ones, especially as mobility declines and these outcomes are related~     to physical and emotional health status of the patient. For Caregivers, the intervention will~     focus on improving Caregiver coping and on managing MS-related problems. Outcomes for both~     will be measured at baseline, 3 months, and 6 months.~      Study Objectives include:~        -  Test whether a caregiver intervention can be integrated into an MS clinical setting.~        -  Determine whether Caregiver outcomes are improved (depression, burden, anxiety, and~          number of Veteran MS problems and safety alerts reported).~        -  Determine whether Veteran outcomes are improved (EDSS walk, timed up and go test,~          self-efficacy, and depression).~        -  Determine which types of Caregivers will benefit most.~        -  Determine which types of Veterans will benefit most.~        -  Refine materials for future clinical research, translation and implementation.~   "
55873|NCT02835664|"~     This study will investigate the effects of 6 week Nicotinamide Riboside supplementation (1000~     mg/day) on metabolic health in healthy (pre)obese humans. The primary objective will be~     hepatic and whole body insulin sensitivity. Secondary objectives, to provide information~     about the underlying mechanism, will be muscle mitochondrial function, brown fat activity,~     ectopic lipid accumulation, energy metabolism, cardiovascular risk parameters, body~     composition and acetylcarnitine levels.~   "
55874|NCT02835651|"~     The purpose of this study is to determine whether palmitic acid (C16:0) and stearic acid~     (C18:0) have different effects on HDL metabolism during the fasted state.~   "
55875|NCT02835638|"~     The main goal of this French multicenter observational cohort study is to prospectively~     collect data assessing the impact of the Adaptative Servo-Ventilation treatment on the~     quality of sleep of patients with central or combined sleep apnea syndrome (SAS) out of Heart~     Failure (HF) with altered ejection fraction, with a predominant central SAS.~   "
55933|NCT02834871|"~     The purpose of this study is to compare the cervical muscular force control , taking into~     account the proprioceptive signals, in patients with and without cervical dystonia.~   "
55876|NCT02835625|"~     Compare synthetic mammography+digital breast tomosynthesis (SM+DBT) with digital mammography~     (DM) as a screening tool for women aged 50-69 years, invited to participate in the Norwegian~     Breast Cancer Screening Program at the screening unit in Bergen, Norway, with regard to early~     performance measures, including prognostic and predictive tumor characteristics, radiation~     doses and cost-effectiveness.~   "
55877|NCT02835612|"~     There are several intervention programs involving multisensory and motor stimulations such~     as, gym, auditory, visual, vestibular and tactile stimulations. We propose to study a~     continuous program of early intervention involving very preterm infants' families in their~     first 12 months of life taking the chance of their neuronal plasticity during this period.~     Preterm infants born in our institution will be included when they complete 48 hours after~     birth (first intervention). All preterm infants and their mothers will be followed during~     neonatal period and pre hospital discharge they will have a second intervention ( to measure~     parental bond ). After discharge they will be conducted to follow up program and we will~     divided all very low birth weight infants included in the study in two groups according~     previous randomization:~        1. Standard care with motor, and cognition evaluation and intervention according to their~          needs~        2. Program of early intervention with parents' orientation independently of f the standard~          evaluation and care that will be performed.~      All phases of neurodevelopment will be evaluated, and the parents will be oriented to~     stimulate motor, language and cognition iteratively and continuously at home; this is a~     innovative method to improve very preterm neurodevelopment outcome.~      Randomization: in neonatal period, preterm infants will be sequentially randomized when they~     completed 48 hours after birth in:~      Group 1- conventional group (CG): standard care, according to the routine care of the NICU~     (skin-to skin care by mother, kangaroo care ).~      Group 2- intervention group (IG): skin-to skin care by mother ( kangaroo care ) plus massage~     therapy by mothers. They will receive the tactile-kinesthetic stimulation by mothers from~     randomization until hospital discharge. Intervention performed exclusively by the mothers was~     based on studies regarding the application of skin stimulations and passive exercises in~     preterm infants.~      Both groups will receive skin-to skin care by mother (Kangaroo Care) according to the routine~     care of the neonatal intensive care unit (NICU).~   "
55878|NCT02835599|"~     REVOLUTION will be a US multicenter observational registry in scope and governed by a~     steering committee of approximately 8 experts in NSCLC and outcomes research. The primary~     goal of the registry is characterizing patterns of use for NSCLC therapy. REVOLUTION will be~     a multicenter registry enrolling approximately 2,500 patients. Additional patients limited to~     those with EGFR mutations may be enrolled following the initial study period as needed to~     ensure adequate sample sizes needed to examine primary questions of interest in the EGFR~     mutant population. Patients will be enrolled over a three year period across approximately 25~     geographically diverse academic as well as community based sites within the US. The five year~     follow-up period will ensure robust survival data for correlations with clinical, tumor, and~     treatment variables.~      The target of 2,500 patients is meant to ensure adequate numbers of NSCLC patients with~     particular characteristics of interest including patients with adenocarcinoma, and EGFR~     mutations and effectively evaluate these patients with respect to key outcomes of interest~     including overall survival, time to progression, stage at progression, secondary metastases~     including brain metastases (at diagnosis and progression), comorbidity burden, and~     performance status at index date.~      The study design allows a cross-sectional perspective with collection of detailed patient and~     clinical characteristics at enrollment followed by longitudinal assessment of clinician and~     patient-reported endpoints every three months. Centralized follow-up will be conducted by~     having sites upload patient data following each visit via the web-based data system, with~     patients who do not show up for site visits being contacted via telephone by the Duke~     Clinical Research Institute (DCRI) call center. Site recruitment and patient enrollment will~     be weighted based upon provider specialty and ability to enroll patients with NSCLC with the~     specified inclusion criteria.~   "
55879|NCT02835586|"~     It is a pilot study to evaluate the feasibility and the efficiency of local delivery of~     paclitaxel after stenting of long femoropopliteal arterial lesions TASC C and D before the~     realization of a large randomized multicentric study. Patients concerned are in critical~     ischemia.~   "
55880|NCT02835573|"~     The purpose of this study is to evaluate the potential diagnostic and prognosis value of~     circulating microRNAs compared with cTnI for the patients of sepsis-induced myocardial injury~     at the emergency department (ED) and intensive care unit (ICU).~   "
55881|NCT02835560|"~     This study compared efficacy and safety of Ilaprazole based bismuth-containing quadruple~     regimen therapy including Ilaprazole 5mg, Bismuth Potassium Citrate 220mg, Clarithromycin~     500mg and Amoxicillin Cap (Amoxicillin) 1000mg BID on the first line eradication treatment of~     H.pylori.~      Participants are defined as persons who have endoscopically confirmed on gastric or duodenal~     ulcer(including scar stage), gastritis and dyspepsia confirmed to be H.pylori positive~     patients in the biopsy and UBT test. For 14 days, participants treated as Esoprazole based~     bismuth-containing quadruple regimen therapy therapy including Esoprazole 20mg, Bismuth~     Potassium Citrate 220mg, Clarithromycin 500mg and Amoxicillin Cap (Amoxicillin) 1000mg BID.~     After treatment, the healing rate was evaluated in the UBT test and Biopsy at 49±5days from~     the first day dosing.~   "
55882|NCT02835547|"~     The hypothesis is that chronic inflammatory dysimmune state promotes the development of~     cardiovascular complications. The biological assumption is based on the fact that chronic~     inflammation promotes lesions of the vessel wall (endothelial alterations, calcification,~     atherosclerosis). The clinical aim is to allow to identify high-risk patients and to act in~     prevention.~      The project CARMIN involves the assessment of cardiovascular risk factors, their management,~     and their influence on cardiovascular prognosis in patients with autoimmune diseases and~     immunodeficiencies acquired. It is based on the creation and monitoring of a cohort of~     patients with different types of dysimmune disorders: systemic lupus erythematosus,~     rheumatoid arthritis, psoriasis, scleroderma, systemic vasculitis ANCA, kidney transplants,~     and hematopoietic stem cells transplants.~   "
55883|NCT02835534|"~     This study is aiming to test the hypothesis that efficacy of rhTNK-tPA was not inferior to~     rt-PA with respect to the 30-day MACCE rates after fibrinolytic therapy for STEMI patients.~     It is a multicenter, randomized, open, parallel, active-controlled, non-inferiority trial.~   "
55884|NCT02835521|"~     Introduction; reception must be understood as the offered attention within the relationship~     between a healthcare worker and the patient, including attitudes of inclusion, hearing,~     valorization of complains and identification of needs, being these individual collective. As~     a part of this process, communication is a primary and indispensable toll through which the~     healthcare team and the patient interchange information.~      Objective: to evaluate the influence of perception of patients suffering of knee~     osteoarthritis over fear, catastrophizing of pain and effectiveness, related to~     intra-articular injection od corticosteroids.~      Material and method: it will be performed a prospective, controlled and randomized study eith~     a blind evaluator on patients with symptomatic knee osteoarthritis submitted to joint~     injection. A hundred patients suffering of symptomatic knee osteoarthritis coming from the~     outpatient area of Rheumatology Division of Federal University of Sao Paulo (UNIFESP) will be~     evaluated, 50 belonging to the intervention group (reception) and 50 to a control group.~   "
55885|NCT02835508|"~     The purpose of the study is to assess the safety and Pharmacokinetic (PK) profile of~     JNJ-56021927 and its active metabolite JNJ-56142060 after single-dose administration of 60~     milligram (mg), 120 mg, and 240 mg JNJ-56021927 as the tablet formulation in healthy male~     Japanese participants.~   "
61003|NCT02768402|"~     The purpose of this study is to assess the safety and performance of the Caisson~     Interventional Transcatheter MitralValve Replacement (TMVR) system for the treatment of~     severe symptomatic MitralValve Regurgitation (MR).~   "
55886|NCT02835495|"~     Diabetes and obesity are both major public health concerns and the prevalence of diabetes is~     even higher in the patient population of the Veterans Administration. This planning project~     is designed to adapt a successful weight-loss program for delivery through an existing~     outpatient clinic to reach local Veterans at risk for developing diabetes. The information~     gathered as a part of this project will be used to plan a larger trial designed to improve~     the health of Veterans by offering them a diabetes prevention program through their usual~     source of healthcare.~   "
55887|NCT02835482|"~     The use of the femtosecond laser causes an increase in the intraocular pressure (IOP) between~     100 mm Hg and 200 mm Hg for a period of about 80 seconds (suction phase).~      If it is known that elevated IOP accelerates the degradation of retinal ganglion cells, whose~     axons form the optic nerve.~      No data has been published to date on potential adverse effects of femtolaser cataract~     surgery performed in patients with glaucomatous optic neuropathy.~      Since some time, spectral-domain optical coherence tomography (SD -OCT) provides a detailed~     analysis of ganglion cell complex (GCC) for which the loss is a marker of glaucomatous optic~     neuropathy. The resolution of this device, about a few microns, can detect even a tiny loss~     of this layer.~      The investigators propose to evaluate the effects of elevated intraocular pressure in~     glaucoma patients undergoing femtolaser cataract surgery, studying the GCC through SD-OCT.~   "
55888|NCT02835469|"~     The purpose of this study is to investigate the ongoing pregnancy rates at 10-11 weeks after~     embryo transfer in patients treated with Menopur® Multidose~   "
55889|NCT02835456|"~     The aim of this study is to determine if the Sharklet catheter, with its unique surface~     micropattern, reduces infections in participants, when compared to a standard silicone~     catheter.~   "
55890|NCT02835443|"~     This clinical trial will evaluate if Deep Brain Stimulation (DBS) is safe for the treatment~     of stroke and will help understand if DBS improves motor recovery for patients who continue~     to have significant impairment.~   "
55891|NCT02835430|"~     -  Gingival recession is defined as the apical migration of gingival margin beyond~          cemento-enamel junction with the exposure of root surface. More than 20% of the~          population presents one or more tooth surfaces with gingival recession.~        -  The main conditions leading to the development of this defect are gingival anatomical~          factors, chronic trauma, periodontitis, malposed tooth and dentinal hypersensitivity.~        -  The main goal of treating gingival recession is to restore the gingival margin to~          cement-enamel junction (CEJ) and normal sulcus with a functional attachment.~        -  A recent innovation in Guided Tissue Regeneration (GTR) technique is the use of second~          generation platelet concentrate, called as Platelet-Rich Fibrin membrane (PRF) that~          contains growth factors and cicatricial properties for root coverage procedures.~        -  Space is necessary to provide a channel for the migration of progenitor cells towards~          and on the denuded root surface, where they can differentiate into cementum and~          periodontal ligament cells.~        -  Since the gingival recession defects are non-space making, it may be difficult using the~          membrane technique alone, and hence, the use of a graft material underneath the membrane~          may help to resolve this problem. Root coverage tended to be better with the addition of~          demineralized freeze-dried bone allograft (DFDBA). These allografts prevent the collapse~          of membrane into the defect, stimulate the proliferation of osteogenic progenitor cells,~          and are thus, capable of promoting regeneration of attachment apparatus.~        -  Till date, no study is available in the literature on clinical evaluation of CAF~          (Coronally Advanced Flap)+PRF+DFDBA vs CAF+PRF for the management of gingival recession~          defects.~        -  And hence, this study is designed to evaluate the clinical efficacy of DFDBA (Rocky~          Mountain Particulate Allograft) for the management of isolated gingival recession~          defects.~   "
55892|NCT02835417|"~     Background~      The fetal heart rate (FHR) is commonly monitored during labor to detect early fetal acidosis.~     FHR variability is traditionally investigated using Fourier transform, however, fetal~     conditions differ from adults (higher frequency, widely instable signal) modifying spectrum~     repartition along frequencies, making this approach inappropriate. New mathematic approach,~     including Multifractal analysis, adaptative multiscale complexity analysis, nearest-neighbor~     based wavelet entropy rate measures, scattering transform, may identify parameters associated~     with fetal acidosis. Modern classification system, driven by the data, based on these~     relevant parameters should help to dsiccriminate the fetus at risk for acidosis and help the~     clinician in decision making for the management and termination of labor. Analysing 20 to 30~     minutes sliding windows with these different methods in a limited number of cases (foetus~     born with acidosis) and controls (foetus without acidosis) should lead to identify relevant~     parameters, which will be submitted to these classification tools. For external validation, a~     large database, including more than 4500 FHR recording documented with foetal outcomes, will~     be used to evaluate the performance of the combination of parameters identify and~     classification system used to discriminate foetuses at risk for short term acidosis or not,~     in order to give a relevant information to the clinician before acidosis occurs, to make the~     appropriate decision.~   "
55893|NCT02835404|"~     The objective of this study was to evaluate the efficacy and complication of the treatment of~     pelvic external combined with 252-Cf neutron intracavitary radiotherapy with or without~     platinum in local advanced cervical cancer patients in the short and long term.~   "
55894|NCT02835391|"~     This study is a post market, multi-centre, randomised study evaluating PerClot compared to~     usual care. PerClot is a CE marked device and is currently used as a haemostat in~     gynaecological surgery throughout Europe. The purpose of this study is to collect additional~     post market data on its use in this indication.~   "
55895|NCT02835378|"~     In France, there is currently no data to directly estimate the number of bilateral upper limb~     amputations, their characteristics and therapeutic care.~      By extrapolation from the Regional Institute of Physical Medicine and Rehabilitation (PMR)~     Nancy in 2005, the number of new cases of amputated patients with prosthetic fitting of the~     upper limb was estimated at 355. Epidemiological data from the 2009-2010 Annual Report of the~     LIMBLESS STATISTICS database (collection of quantitative clinical data and demographic of~     amputees patients referred by orthopaedic centres in the United Kingdom , whose population's~     characteristics are similar to France) identified 395 incident cases of upper limb amputation~     with, 6 bilateral amputations observed. The causes are varied: traumatic, infectious or~     related to diabetes. The population was relatively young, aged between 15 and 54 year old.~      On this basis, the estimated number of new cases of bilateral upper limb amputations~     throughout France should therefore be about 40 incident cases over a 5-year period.~      This observational study is aimed at collecting comprehensive and high quality data to~     describe the French population of bilateral upper limb amputees.~   "
55918|NCT02835066|"~     This pilot trial studies patient function/fitness and psychosocial health in improving~     health-related quality of life and decreasing treatment-related toxicity in patients with~     stage I-IV non-small cell lung cancer. Studying function/fitness and psychosocial health may~     help doctors improve conventional therapy in patients with non-small cell lung cancer.~   "
55896|NCT02835365|"~     Baclofen is an agonist of the amino-butyricum B (GABA-B) receptor used for a long time in~     neurology to treat spastic contracture. Several clinical studies have suggested its efficacy~     in the treatment of alcohol-dependence in low, even in case of cirrhosis and high dose.~     French drug authority has authorized its use in 2012 whereas the l'European Association for~     the Study of the Liver recommends to perform additional studies on this indication.~      The goal of this observational study is to evaluate the use of baclofen for~     alcohol-dependence in real life care as well its efficacy.~   "
55897|NCT02835352|"~     This study evaluates the impact of essential oils massage on anxiety of patients who are~     suffering from cancer at a metastasis stage. Half of patients will be massaged first by~     essential oils and then by oil only. The other half will be massaged first by oil and then by~     essential oils.~   "
55898|NCT02835339|"~     The purpose of this study is to learn how medications participant will receive in the course~     of their delivery are metabolized (broken down by the body). The investigators hope to learn~     more about the way drugs are metabolized by pregnant women, and how those drugs are~     distributed in the blood and body compartments and cleared in the urine, and how maternal~     body weight affects the metabolism. With this information the investigators will be able to~     develop a treatment regimen considering factors in the body that affect magnesium levels so~     that the investigators can improve treatment of pregnant women. The goal of the study is to~     understand how different dosing of magnesium sulfate affects blood levels of the magnesium in~     larger women.~      Magnesium sulfate is generally given to patients to protect the mother against seizures in~     the case of preeclampsia. Different hospitals in the United States use different doses of~     magnesium sulfate. Participants will receive one of two accepted doses of magnesium sulfate~     for preeclampsia. The dose is usually 4g - 6g at the start, with another dose of 2-3 g every~     hour until 24 hours after delivery. Participants will be assigned to either a dose of 4 g at~     the start, followed by 1g every hour; or a dose of 6 g at the start, followed by 2g every~     hour until treatment for preeclampsia is complete. Participants will receive magnesium~     sulfate in the course of their normal clinical care whether or not they participate in this~     study.~   "
55899|NCT02835326|"~     The Collaborative Lifestyle Intervention Program in Knee OsteoArthritis Patients (CLIP-OA)~     compares a novel community-based exercise and dietary weight loss program to the Arthritis~     Foundation's Walk with Ease intervention on improved mobility in knee osteoarthritis (OA)~     patients.~   "
55900|NCT02835313|"~     Stroke survivors, as a group, are extremely inactive and this has serious consequences for~     them, including an increased risk of a second stroke and developing other diseases. This~     study investigates a novel intervention designed to improve everyday activity after stroke by~     combining walking training to improve walking capacity with a program to encourage more daily~     walking.~   "
55901|NCT02835300|"~     This project will preliminarily validate CampAir, an empirically-based dynamic e-health~     intervention (based on the evidence-based ASMA) to assist adolescents with uncontrolled~     asthma to learn how to manage their illness and improve their asthma control. In addition to~     developing a highly novel product for adolescents with asthma, the research proposed for this~     project will address unique scientific questions. Despite the high asthma prevalence among~     adolescents, few interventions have specifically targeted adolescents. This study is~     innovative in that it is among the few to focus on adolescents, who are often overlooked by~     the healthcare system. This research will assess factors associated with successful~     implementation of CampAir, thereby providing new information regarding how e-health~     interventions can be effectively developed and implemented for use with adolescents with~     asthma.~   "
55902|NCT02835287|"~     The overall objective of the proposed cluster randomized trial is to test whether~     implementation of protocol-based integrated care will improve CVD risk factors (glycated~     hemoglobin [HbA1C], systolic blood pressure [SBP], and LDL-cholesterol) over 18 months and~     reduce major CVD events (non-fatal stroke, non-fatal myocardial infarction, hospitalized~     heart failure, and CVD mortality) over 3 years among patients with type 2 diabetes and~     additional CVD risk factors or clinical CVD compared to usual care in community clinics in~     Xiamen, China.~   "
55903|NCT02835274|"~     The primary objective is to characterize the programming effects of Boston Scientific~     Vercise™ PC System using the DBS Directional Lead for bilateral STN DBS for the treatment of~     Parkinson's disease in acute and chronic settings.~   "
55904|NCT02835261|"~     The overall goal of this project is to test the hypothesis that long-term, sustained sleep~     restriction (SR), in women, will lead to increased cardio-metabolic risk. This will be~     characterized by increases in visceral adiposity, unhealthy lifestyle behaviors (poor dietary~     quality and low physical activity) and cardio-metabolic risk factors (blood pressure, glucose~     intolerance) relative to habitual sleep (HS). The investigators expect these changes to be~     worse in pre- compared to post-menopausal women.~   "
55905|NCT02835248|"~     Medical alert devices with automatic fall detection functionality use accelerometry to detect~     a fall and can signal for help if the wearer forgets to, or is incapable of, pressing the~     alert button. This can save lives and prevent complications associated with long periods of~     time spent on the floor after a fall. In this project, the sensitivity and false alarm rate~     of a commercially available medical alert device will be tested in a population of 200~     community-dwelling older adults.~   "
55906|NCT02835235|"~     This trial is conducted in the United States of America. The aim of the trial is to~     investigate Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Male and~     Female Subjects being overweight or with obesity~   "
55907|NCT02835222|"~     This pilot phase II trial studies how well selinexor works when given together with~     induction, consolidation, and maintenance therapy in treating older patients with acute~     myeloid leukemia. Selinexor may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Drugs used in chemotherapy, such as cytarabine and~     daunorubicin hydrochloride, work in different ways to stop the growth of cancer cells, either~     by killing the cells, by stopping them from dividing, or by stopping them from spreading.~     Selinexor with induction, consolidation, and maintenance therapy may kill more cancer cells~     in older patients with acute myeloid leukemia.~   "
55919|NCT02835053|"~     The investigators will examine the association between preoperative frailty and postoperative~     outcomes and resource utilization after emergency general surgery.~   "
55908|NCT02835209|"~     Mechanical ventilation is a life-sustaining intervention in premature infants with~     respiratory difficulties. There is relative consensus when to intubate and provide positive~     pressure mechanical ventilation in the presence of respiratory failure. In contrast,~     discontinuation of mechanical ventilation during recovery remains largely subjective. A~     potential predictive tool for neonatal extubation is the Spontaneous Breathing Trial (SBT).~     The efficacy of SBT or other tests used in older patient populations in improving clinical~     judgment is questionable in the neonatal population with its unique physiology, respiratory~     mechanics and drive factors. Christiana Care Health System NICU currently uses the SBT as a~     standard part of neonatal assessment for extubation from mechanical ventilation.~      Infants in the CCHS NICU are routinely cared for in multiple positions (prone, supine,~     lateral) throughout the day. What is unknown is the impact of infant positioning on the SBT.~     An SBT performed in one position may not predict infant respiratory status after extubation~     in another position. Understanding the impact of infant positioning and work of breathing~     indices independently or in combination with an SBT will aid clinicians in decision-making~     and potentially decrease neonatal morbidity (inaccuracy with timing and safety of~     extubation). This pilot study will begin to explore these clinically relevant factors.~      Objectives: This pilot study will investigate the (1) role of infant position on SBT score~     and (2) the relationship of work of breathing indices in reference to the SBT score and~     infant position.~   "
55909|NCT02835183|"~     The investigators propose a randomized cross-over study Phase 1 Clinical trial. 30 type 1~     diabetes adult outpatients using insulin pumps and continuous glucose monitoring system will~     be recruited from the Endocrinology Clinic at the Mayo Clinic Arizona. Participants will be~     randomly assigned to 4 weeks of using their pump bolus wizards to decide insulin boluses and~     then 4 wks of using iDECIDE to receive recommendations for insulin dosing, or vice versa. The~     primary outcomes to compare iDECIDE's insulin dosing algorithm against the pump calculators~     will be: mean postprandial glucose level and number of events with excessive blood glucose~     highs and lows.~   "
55910|NCT02835170|"~     This is a randomized, double-blind, placebo-controlled parallel group study on the efficacy~     and safety of intramuscular injections of autologous immunoglobulin in patients with~     moderate-to-severe atopic dermatitis.~   "
55911|NCT02835157|"~     Fluid resuscitation is the cornerstone of pediatric shock management; current practices of~     fluid resuscitation in children are not evidence based. Normal saline is the preferred~     crystalloid recommended during initial resuscitation in shock, as the incidence of~     hyponatremia is lower with normal saline compared to all other fluids available and commonly~     used. However, normal saline has its own set of undesired physicochemical actions. Emerging~     data strongly indicate the increased incidence of hyperchloremia, metabolic acidosis and~     consequently, acute kidney injury associated with infusion of large volumes of normal saline.~     Balanced salt solutions or crystalloids, which have composition resembling plasma but lower~     chloride concentrations than normal saline, clearly decrease the risk of hyperchloremia and~     metabolic acidosis in adult as well as pediatric studies when used during the peri-operative~     period. The results favored balanced solutions in comparison to normal saline. Recent~     systematic reviews comparing balanced or buffered versus non-buffered fluids for surgery in~     adults favored the former solution as the metabolic derangements were less with the use of~     this type of fluid. In adult patients, the two solutions have been compared in various other~     settings as well such as in traumatic brain injury and in shock. The results favored balanced~     solutions in comparison to normal saline. However, in the non-surgical setting there is a~     paucity of evidence on the use of these solutions in children with shock and more evidence~     needs to be generated to support or refute the use of this fluid as compared to normal~     saline.~      Given this background, the investigators decided to compare the effect of two solutions on~     the incidence of acute kidney injury in children resuscitated with either of the two fluids.~     Children receiving volumes of at least 20 ml/kg in the first hour of resuscitation as boluses~     would be enrolled and followed up for the proposed outcome variables. The investigators plan~     to enroll 708 patients over a period of 3 years. The investigators believe that the proposed~     study will provide the answer to the safety of normal saline which is the most widely~     preferred initial fluid for fluid resuscitation in children with shock due to sepsis.~   "
55912|NCT02835144|"~     The prevalence of addictive disorders in old age is increasing. Age specific and appropriate~     therapeutic concepts tailored to in-patients thus represent a promising approach for the~     future. The investigated therapeutic intervention is a therapy program for integrated~     qualified acute treatment of alcohol and drug problems (TIQAAM).~   "
55913|NCT02835131|"~     Congenital hyperinsulinism is a rare condition that can cause life-threatening hypoglycemia.~     Current treatment for congenital hyperinsulinism is often suboptimal, and such individuals~     may respond to a new somatostatin analog, pasireotide. This is a compassionate use study of~     the effects of pasireotide on individuals with suboptimally treated congenital~     hyperinsulinism.~   "
55914|NCT02835118|"~     This study aims to assess the safety, tolerability, and pharmacokinetics (PK) of oral doses~     of surotomycin (CB-183,315) administered for 14 consecutive days in healthy males and~     females.~   "
55915|NCT02835105|"~     This study aims to assess the safety, tolerability, and pharmacokinetics (PK) of a single~     oral dose of surotomycin (CB-183,315) at ascending dose levels when given to healthy males~     and females.~   "
55916|NCT02835092|"~     The study evaluates the effects of two commercially available weight loss programs, the TSFL~     and the MEDD programs, each compared to a self-directed control diet, on changes in body~     weight over a 16-week weight loss phase, in apparently healthy overweight and obese men and~     women.~   "
55917|NCT02835079|"~     Duchenne muscular dystrophy (DMD) is a progressive devastating disease that affects mainly~     boys, with an incidence of about 1:3,500 live births. The pathology of DMD is a result of~     non-repaired muscle damage that leads to muscle-tissue replacement by scar tissue, a process~     known as fibrosis. Currently, there is no effective treatment for the disease. The only~     therapy offered to these boys are steroids which slightly delayed the disease progression.~     The boys lose their ability to walk at around the age of 12, and die in the 4th decade of~     life from severe heart and lung problems.~      In this study investigators will test the efficacy of Tamoxifen treatment in ambulatory DMD~     boys. Tamoxifen is a drug used for palliative treatment of breast cancer patients and has an~     outstanding safety profile. In addition, Tamoxifen was tested in the past in boys, for other~     pediatric indications, and showed an excellent safety with no side effects.~      Tamoxifen is being tested in this study, as a therapy for DMD, for the following reasons:~      (i) it was shown to have anti-fibrotic effect in multiple in-vivo systems; (ii) it assists in~     the repair of damaged muscles.~      In other words, Tamoxifen is expected to have a synergistic effect on DMD patients, due to~     its dual mechanism of action. Indeed, Tamoxifen was shown to have significant beneficial~     effects in the mdx mouse model of DMD. Also, a small compassionate cohort of 3 boys, treated~     for 6 months with Tamoxifen, yielded very encouraging results.~   "
55934|NCT02834858|"~     Stem cell therapy has been a new and effective therapy in recent years for diabetic foot.This~     study intends to establish an optimal clinical research program, and attempts to break the~     technical bottleneck in the stem cell therapy for treating diabetes related vascular~     complications.~   "
55920|NCT02835040|"~     Pneumonia is the commonest illness requiring hospitalization in Australia. Elderly patients~     account for most admissions and incur highest costs due to longer hospitalizations, higher~     readmission risks and poor functional outcomes. Previous clinical trials show a number of~     medical and allied health interventions can effectively shorten hospitalization or reduce~     readmissions, but these have been poorly and inconsistently applied in practice. This~     proposed research builds on previous studies by applying these interventions as a~     standardized combined package, evaluating their effectiveness in a real world Australian~     setting and quantifying effects on both clinical outcomes and health service costs.~   "
55921|NCT02835027|"~     Study of acute lower ischemia therapies based on data collected from the Swedish Vascular~     Surgery Registry between 1994 and 2014.~      Primary endpoint is long term amputation-free survival and secondary end-points are 30 days~     and 1 year amputation-free survival as well as different revascularization techniques results~     and time trends.~   "
55922|NCT02835014|"~     This study will focus on screening for mental health symptoms in adolescents with type 1~     diabetes mellitus (T1DM) while assessing the relationship of these symptoms with a~     parent-reported parenting styles survey, and the youth's report of their ability to manage~     their own diabetes care through a self-efficacy survey. Gender differences will be explored~     in relation to the different measures.~   "
55923|NCT02835001|"~     Hyperinflation Assessment After Treatment by Lung Volume Reduction Coil (HEAT-LVRC) on~     Hyperinflation in Severe Emphysema~   "
55924|NCT02834988|"~     The investigators hypothesize that performing SLND (instead of complete lymphadenectomy) will~     decrease complications such as hemorrhage, lower extremity lymphedema and lymphocyst~     formation while enhancing quality of life in EC patients with low risk for nodal involvement.~      The investigators also hypothesize that SLND is an effective method of staging these~     patients. Studies have shown that SLN mapping identifies positive lymph nodes in women with~     newly diagnosed EC and this prognostic information obtained from SLND could guide selection~     of adjuvant treatment and improve overall survival.~      Using SLND as an alternative may also have additional medical and economic impacts. Prolonged~     hospitalization and associated costs can be avoided by shortening overall surgery duration.~   "
55925|NCT02834975|"~     The investigators hypothesize that tumor cell killing by cytotoxic chemotherapy exposes the~     immune system to high levels of tumor antigens.The combination of Paclitaxel/Carboplatin and~     Pembrolizumab will invigorate tumor-specific T-cell immunity in this setting by inhibiting~     PD-L1/PD-1 signaling, and may result in deeper and more durable responses compared with~     standard chemotherapy alone.~   "
55926|NCT02834962|"~     To study the difference between single and double bundle ACL graft cross-sectional dimensions~     compared with native ACL using postoperative 3-D MRI.~   "
55927|NCT02834949|"~     The purpose of this study is to evaluate the efficacy of a Substance-Free Activity Session~     (SFAS) as a supplement to a brief motivation intervention (BMI) in reducing alcohol use and~     alcohol-related consequences in college students.~   "
55928|NCT02834936|"~     This study is designed to evaluate the efficacy and safety of Pyrotinib in patients of~     advanced pre-treated Non-small cell lung cancer With HER2 Mutation.~      To observe objective response rate (ORR) of pyrotinib in NSCLC With HER2 Mutation. To observe~     Progression free survival (PFS). To assess the overall survival (OS).~      A secondary aim is to obtain safety information.~      To explore the relationship between biomarkers and the toxicity/efficacy of Pyrotinib.~   "
55929|NCT02834923|"~     The Patient Centered Medical Home (PCMH) and the Chronic Care Model (CCM) are complementary~     clinical intervention frameworks that are commonly invoked to support better type 2 diabetes~     (T2DM) outcomes in primary care. Self-management Support (SMS) is a core component of both~     the PCMH and CCM, and focuses on the central role of patients in managing their illness by~     engaging with and adopting healthy behaviors that promote optimal clinical outcomes. Despite~     its recognized importance, SMS programs for diabetes continue to demonstrate limited~     effectiveness in the real-world of primary care.~      SMS is comprised of two complementary and interactive components: (1) patient engagement~     (e.g., the process of eliciting and responding to patients emotions and motivations related~     to health behaviors), and (2) behavioral change tools (e.g., selecting specific goals,~     creating action plans). While several sophisticated SMS programs have been developed for~     T2DM, the vast majority are designed with a narrow focus on behavioral change tools, largely~     ignoring unique aspects of the patient context that drive and maintain health behavior.~     Considerable clinical research suggests that the addition of a structured, evidenced-based~     program of patient engagement can maximize the effectiveness of SMS programs for patients~     with T2DM in primary care.~      To date there has been no systematic study of the degree to which fully integrating enhanced~     patient engagement as part of SMS will increase the initiation and maintenance of behavior~     change over time, and for which kinds of patients enhanced patient engagement is essential.~     To address this gap, the investigators will compare a state-of-the-art, evidence-based SMS~     behavior change tool program, called Connection to Health (CTH), with an enhanced CTH program~     that includes a practical, time-efficient patient engagement protocol, to create a program~     with an integrated and comprehensive approach to SMS, called Enhanced Engagement CTH~     (EE-CTH). The current study will directly test the added benefit of EE-CTH to CTH with regard~     to self-management behaviors and glycemic control in resource-limited community health~     centers, where vast numbers of patients with T2DM from ethnically diverse and medically~     vulnerable populations receive their care. The investigators will use an~     effectiveness-implementation hybrid design, employing the Reach Effectiveness Adoption~     Implementation Maintenance (RE-AIM) framework to test these two SMS programs for T2DM. This~     will provide critical information that will support dissemination and implementation of~     effective SMS programs in resource-limited primary care settings, serving diverse and~     medically vulnerable populations with much to gain from improved SMS.~   "
55930|NCT02834910|"~     Enterobacteriaceae are bacteria of the gastrointestinal tract which are also the most~     frequently involved in bacterial infections, especially urinary tract infections. Because of~     their presence in the gut, these bacteria are the most exposed to antibiotic treatment~     administered to patients.~      Therefore, many antibiotic resistance mechanisms are observed in some of them. Quinolone~     antibiotics are often used because of their distribution in the body, of the great number of~     bacterial species that are sensitive to these antibiotics and the possibility to give oral~     treatments.~      For a long time no transferable resistance gene to quinolones from one bacterium to another~     had been observed. This phenomenon has been demonstrated in 1998 in a bacterium of the~     Klebsiella pneumoniae species carrying a qnrA gene which encodes a protein that protects the~     target of the antibiotic in the bacteria. Since several genes have been observed. These genes~     reduce the sensitivity of the bacteria without ever reach detectable resistance levels on the~     tests commonly used in the laboratory. However, these genes are often found among~     enterobacteria in combination with other mechanisms of resistance to other classes of~     antibiotics including beta-lactam antibiotics that are widely used antibiotics.~      Moreover, it is considered that quinolone administration to bacteria carrying these qnr genes~     could promote the emergence of mutants resistant to quinolones to a more high-level. That~     furthers multiresistance emergence when the bacteria is already resistant to beta-lactam~     antibiotics.~      The aim of this study performed between April 2008 and March 2009 was to collect strains~     resistant to beta-lactams because of the production of enzymes, called extended-spectrum~     beta-lactamase to determine quinolone resistance gene frequency in these bacteria.~      Meanwhile, control patients were selected to seek the emergence of these genes risk factors.~      The clinical study failed to identify specific risk factors, however, the biological study~     enhanced the knowledge on this issue with the setting-up of a method for rapid detection of~     these plasmidic mediated quinolones resistance genes and the description a new plasmid~     containing a qnr gene, qnrD, whose study is still ongoing.~   "
55931|NCT02834897|"~     The purpose of this study and demonstrate the reliability of EOS imaging system in the~     measurement of internal diameters of obstetrical pelvis versus Goldstandard current that is~     the pelviscanner.~   "
55935|NCT02834845|"~     Controlled hypotension is a preferred method for reducing surgical bleeding during~     septoplasty operations however, the level of hypotension and bradycardia should not disrupt~     cerebral oxygenation. On this account, the investigators aim to investigate the effects of~     different volatile anesthetics combined with a short-acting opioid on cerebral oxygenation~     during controlled hypotension using near infrared spectroscopy.~   "
55936|NCT02834832|"~     This study evaluates the effect of coatings on bacterial adhesion on denture acrylic and the~     wear of denture teeth.~   "
55937|NCT02834819|"~     The purpose of this study is to determine whether nebulized 3% hypertonic saline is more~     effective than the current standard of care in the treatment of viral bronchiolitis in~     children.~   "
55938|NCT02834806|"~     This study aims to assess the device success and the safety of Medinol's Drug Eluting Stent -~     BioNIR - with a modified delivery system. The BioNIR Ridaforolimus Eluting Coronary Stent~     System is a single use device/drug combination product comprising:~        -  A mounted Cobalt Chromium (CoCr) alloy based stent~        -  A Rapid Exchange (RX) delivery system~        -  A polymer matrix coating - Poly n-butyl methacrylate (PBMA) and CarboSil®~        -  Ridaforolimus drug - CAS Registry Number: 572924-54-0 It is indicated for improving~          coronary luminal diameter in patients with symptomatic heart disease due to lesions in~          vessels with reference diameters of 2.5 mm to 4.25 mm, including complex lesions.~   "
55939|NCT02834793|"~     This study is being conducted to demonstrate that perampanel given as adjunctive~     anti-epileptic treatment is superior to placebo in reducing the number of drop seizures in~     participants with inadequately controlled seizures associated with Lennox-Gastaut Syndrome~     (LGS).~   "
55940|NCT02834780|"~     The primary purpose of this study is to determine the maximum tolerated dose (MTD) and~     recommended Phase 2 dose (RP2D) of H3B-6527 (Part 1), and to assess the safety and~     tolerability of H3B-6527 as a single agent administered orally (Part 2) in participants with~     advanced hepatocellular carcinoma (HCC) or intrahepatic cholangiocarcinoma (ICC).~   "
55941|NCT02834767|"~     Obstructive sleep apnea (OSA) carries serious health consequences for patients. Evidence~     exists that some behavioral (e.g. exercise based) therapies may assist in lessening the~     severity of this disorder. The proposed investigation will examine the effects of eight weeks~     of genioglossus muscle strength training on measures of snoring and OSA severity as well as~     genioglossus protrusive muscle strength.~   "
55942|NCT02834754|"~     This is a pilot study that will determine the endoscopic recurrence of Crohn's disease 12~     months after curative, resective ileal or ileocolonic surgery in patients receiving~     post-operative vedolizumab (Entyvio) or placebo. The investigators hypothesize that the~     administration of post-operative vedolizumab will decrease the endoscopic recurrence of~     Crohn's disease.~   "
55943|NCT02834741|"~     This is a first in human study of NYX-2925. It will evaluate single and multiple ascending~     doses of NYX-2925 in healthy volunteers.~   "
55944|NCT02834728|"~     This was a prospective multicenter cohort study of elderly people admitted to medical wards~     via emergency departments. Subjects were followed up to 36 months. It aimed to study the~     inhospital pathways and adverse geriatric outcomes. In all, 1306 subjects were included :~     85+/-5 years, and mainly women (65%).~   "
55945|NCT02834715|"~     The main aim of the study is to assess the short term and 1-month metabolic effects of Stevia~     rebaudiana bertoni in patients with type 2 diabetes.~   "
55946|NCT02834702|"~     The study aims to examine the efficacy and safety of sinew acupuncture for chronic mechanical~     neck pain (CMNP).~   "
55947|NCT02834689|"~     Walking is encouraged for people with type 2 diabetes but there is little evidence that~     performing a bout of walking can improve glucose control. Furthermore, it is unknown how~     participant characteristics (e.g., age, sex, medications) impact the acute glucose responses~     to walking in people with type 2 diabetes. The primary purpose of this study is to examine~     how a standardized bout of walking impacts glucose control assessed over 24 hours using~     continuous glucose monitoring. A secondary purpose is to determine whether responses are~     influenced by age, sex, and medication use.~   "
55948|NCT02834676|"~     The aim of the study is to evaluate the clinical effects of Discogel® Radiopaque Gelified~     Ethanol as therapeutic substance for nucleolysis application in the patients with cervical~     disc hernia who had chronic pain and weakness on the neck, shoulders and arms.~   "
55949|NCT02834663|"~     Title of study:~      Effects of Ranibizumab to delay or regression non-proliferative diabetic retinopathy(NPDR)~     with DME assessed by microaneurysm changes: A pilot study Objectives To evaluate the effects~     of intravitreal Ranibizumab injection on microvascular changes in eyes of mild-to-moderate~     NPDR with DME~      Primary objective:~      To compare microvascular changes assessed by microaneurysm counts in eyes of mild-to-moderate~     NPDR with DME after intravitreal Ranibizumab injection from baseline through 6 months after~     treatment.~      Secondary objectives:~      To investigate other efficacy endpoints including other microvascular, anatomical, visual~     acuity change and safety in mild-to-moderate NPDR with DME after intravitreal Ranibizumab~     injection from baseline through 6 months after treatment.~   "
55950|NCT02834650|"~     This study will collect MRI from healthy volunteer boys and boys with Duchenne Muscular~     Dystrophy (DMD) to help researchers identify and validate cardiac MRI biomarkers to better~     understand the health of the heart and changes in heart health over time in boys with DMD.~      Currently, there is a lack of sufficiently well characterized cardiac MRI biomarkers that can~     serve as endpoints for detecting on-target and/or off-target cardiac effects during clinical~     drug trials for boys with DMD.~      Consequently, the first objective is to identify and characterize several cardiac MRI~     biomarkers for boys with DMD.~   "
55960|NCT02834520|"~     60 individuals were subdivided into 2 groups, 30 patients with oral lichen planus, 30 control~     individuals. Expression of miRNA-138 and cyclin D1 were evaluated in oral mucosa utilizing~     Quantitative real-time polymerase chain reaction and immunohistochemistry.~   "
55961|NCT02834507|"~     The purpose of this study is to determine the effect of two different multiple-dose regimens~     of nebicapone in comparison to placebo and entacapone 200 mg on the pharmacokinetics of~     levodopa in Parkinson's Disease (PD) patients.~   "
55962|NCT02834494|"~     Assess the accuracy of the sequential measurements by 3D Shear Wave Elastography (SWE) for~     predicting histological response to neoadjuvant chemotherapy in patients with locally~     advanced breast cancer.~   "
55951|NCT02834637|"~     Cervical cancer is the most common cancer in women aged 15-44 years in East Africa, and~     mortality rates are very high. HPV vaccines are most effective if given to girls who have not~     yet acquired HPV infection. In Tanzania, HPV vaccine has been shown to be safe, acceptable~     and can be delivered with high coverage (around 80%). However, the cost of delivering HPV~     vaccine is considerably higher than costs for traditional infant/child vaccinations. This is~     primarily because of costs to establish outreach programmes and associated personnel costs~     including nurses who must spend significant time away from their posts to deliver vaccine,~     especially if multiple doses are needed. There is global interest in simplifying HPV vaccine~     delivery by reducing the number of doses. If a single dose could be given, this could halve~     the costs of delivery, making it more accessible to the populations that need it most.~     Recently, the WHO recommended that 2 doses of HPV vaccine could be given to young girls,~     based on studies in high and upper middle income countries. However in Africa high rates of~     infections like malaria and worms can affect immune responses to vaccines. It is essential to~     know that reducing the number of doses does not reduce the protective immune response of~     these vaccines. The investigators are conducting a trial in Tanzanian girls aged 9-14 years~     to establish whether a single dose of HPV vaccine produces immune responses that are likely~     to be effective in preventing cervical cancer. Two different HPV vaccines, the bivalent (2-v)~     vaccine that protects against HPV 16/18 (the cause of 70% of cancers) and a new 9-valent~     (9-v) vaccine that protects against 9 HPV types, will be compared. The trial will randomise~     900 girls to 6 groups and follow them for 36 months. Girls will receive the 2-v or the 9-v~     HPV vaccine, as 1, 2 or 3 doses. Girls receiving 1 or 2 doses will be compared with those~     receiving 3 doses of the same vaccine, to ensure that the reduced dose regimen produces an~     immune response that is not inferior to the standard 3 doses. The immune responses in this~     study will also be compared with results from other countries where the vaccine has been~     shown to be protective. This will provide information about whether a reduced number of doses~     is likely to be protective in Africa. This work will be extremely important in informing~     future HPV vaccination strategies and will be one of the first randomised trials of 1 and 2~     doses of any HPV vaccine in Africa.~   "
55952|NCT02834624|"~     Premature infants frequently have trouble breathing after birth. If the respiratory disorder~     is caused by surfactant deficiency or dysfunction, the disease is treated with a medication~     called surfactant that is given to the infant through a tube inserted into the windpipe. This~     study will compare the safety of two of the commonly used surfactants, poractant and~     calfactant,in the United States. Poractant has added chemicals called phospholipids which are~     known to cause inflammation and irritation in the body of premature infants. The~     investigators will compare this to another similar surfactant that does not contain these~     chemicals by looking at samples from the windpipe, while the tube is in place, and from blood~     tests in the first few days of life.~      The investigators are hoping to learn whether calfactant is a safer therapeutic agent to~     treat respiratory distress syndrome in preterm infants compared to poractant.~   "
55953|NCT02834611|"~     This study is a dose escalation study of Ceramide NanoLiposome in patients with advanced~     solid tumors.~   "
55954|NCT02834598|"~     The study evaluates the benefits of a rocking movement on well-being and attention, through~     high-density electroencephalography recordings. The effect of the rocking movement is~     compared to a seated position and a lying position.~   "
55955|NCT02834585|"~     Adult soft tissue sarcomas (STS) are rare tumours with an estimated incidence averaging 5/100~     000/year in Europe. The prognosis of soft tissue sarcomas is dominated by local recurrence~     and distant metastasis. A link seems to exist between local recurrence and overall survival.~     Local recurrence occurs in approximately 16-29% of STS of the limbs. A combination of~     resection and radiotherapy is the optimal treatment of primary tumours according to~     histological grade and surgical result. Modern imaging techniques such as ultrasound (US),~     magnetic resonance (MR) and computed tomography (CT) are normally used to rule-out a~     recurrence in patients operated on for STS. However, none of this technique is perfect and~     different advantages and drawbacks have to be considered in choosing one or another~     technique. In the past, US was used in tumour follow-up to detect tumour recurrences, however~     these studies didn't use high-resolution transducers and the timing of imaging respect to~     surgery was not defined. The recent advances in transducer technology improved the diagnostic~     capabilities of US.~      For the evaluation of limbs soft-tissue masses, US is widely used as a first level modality.~     The reasons are that US is widely available, fast, easily repeatable and often more~     accessible than CT and MR Imaging. In addition, US equipped with high-frequency transducers~     have a spatial resolution that may be comparable or higher than that of MR Imaging and CT in~     the evaluation of superficial soft-tissues. US and MR Imaging are often not able to~     differentiate benign from malignant tumours, therefore several lesions detected with US or MR~     Imaging warrant biopsy. The clinical practice guidelines of the ESMO (European Society of~     Medical Oncology) published in 2010 found that there are no published data to indicate the~     optimal routine follow-up policy of surgically treated patients with localized disease.~     Moreover, it has not been demonstrated that, for limb sarcomas recurrences, MR Imaging is~     superior and cost-effective compared to US for the assessment of the primary site.~     Considering that surgically treated intermediate-/high-grade patient may be followed~     frequently, even every 3-4 months in the first 2-3 years and considering that performing US~     is easier than having MR Imaging, the purpose of this study is to evaluate the diagnostic~     performance of US in the detection of local recurrences of adults patients with soft tissue~     sarcomas of the limb.~   "
55956|NCT02834572|"~     Young Black men who have sex with men (MSM) and transwomen in the US are affected by HIV at~     severely disproportionate rates. A key component of HIV prevention for communities at risk is~     diagnosing HIV infections through regular HIV testing. A significant proportion of young~     Black MSM and transwomen have not tested in the prior year. This research study seeks to~     address low HIV testing rates among young Black MSM and transwomen by testing a brief~     Internet-based HIV testing intervention optimized for mobile devices. The intervention takes~     advantage of the variety of HIV testing options now available, including the HIV self~     testing, couples-based HIV counseling and testing and traditional clinic-based testing and~     will provide men and transwomen with a tailored recommendation of their optimal HIV testing~     approach. The investigators are conducting a pilot randomized study among young Black MSM and~     transwomen followed for 6 months to estimate the intervention's potential efficacy in~     increasing HIV testing.~   "
55957|NCT02834559|"~     This study investigates the effectiveness of a simple treatment to prevent proliferative~     vitreoretinopathy (PVR).~      Intraoperative intravitreal 5-fluorouracil (5-FU) and low molecular weight heparin (LMWH) is~     used as a prophylactic therapy in high-risk patients with primary rhegmatogenous retinal~     detachment (RRD). Our major motivation is to reduce the incidence of PVR in the group that~     receives the trial drug.~   "
55958|NCT02834546|"~     The aim of this pilot study is to correlate the sorafenib plasma concentration to observed~     toxicity and to the disease control rate in 100 patients undergoing a palliative treatment of~     hepatocellular carcinoma (HCC). If some correlations are observed, we will consider planning~     a larger interventional study to adjust sorafenib daily dose to plasma concentration.~   "
55959|NCT02834533|"~     Objective: To investigate the role of virtual reality (VR) paired with robotic-assisted gait~     training (RAGT) compared with RAGT alone in patients with Multiple Sclerosis (MS).~      Method: A Randomized, double-blind, controlled clinical trial was carried out in forty~     patients with relapsing remitting MS. All patients were randomized into two groups. One group~     practiced Lokomat without VR (group G1), the other one the Lokomat with VR (G2). Both the~     groups performed 40-1h-training sessions by Lokomat (for 3 times a week). A skilled-blinded~     neurologist and psychologist administered clinical and neuropsychological scales. All the~     clinical tests were performed at the beginning (T0) and at the end (T1) of the rehabilitative~     program.~   "
55976|NCT02834312|"~     This dose-finding study is being conducted to select the daily oral dose of estetrol (E4) for~     the treatment of vasomotor symptoms (VMS) in post-menopausal women.~   "
55963|NCT02834481|"~     The main objective is to assess correlation between ANI/NIPE values and external evaluation~     COMFORT B scale during painful medical cares and during said comfort medical cares in~     intubated children admitted in pediatric intensive care unit postoperative of cardiac surgery~     with extracorporeal circulation.~   "
55964|NCT02834468|"~     The project was undertaken by Qilu Hospital, Shandong University in China. In order to report~     the efficacy and safety of dexamethasone combined with rituximab, cyclosporin and intravenous~     immunoglobulin in the management of newly diagnosed ITP patients.~   "
55965|NCT02834455|"~     Recurrent unilateral, non-infectious pleural exudate is suspicious for primary or secondary~     pleural malignancy. Both conditions are associated with 5-year survival of 10%. Work-up is~     difficult, as the pleural surface is large and <33% of pleural malignancies shed malignant~     cells to the pleural fluid. Even so, additional tissue biopsies are needed for establishing~     mutation status for targeted therapies.~      Optimal imaging to guide tissue sampling is pivotal. PET-CT has higher sensitivity than~     conventional CT for detecting malignant lesions >10mm. However, no randomised trial has~     investigated differences in diagnostic accuracy, time-to-diagnosis, or economics. Falsely~     PET-positive lesions in e.g. colon however, lead to more derived tests than do CT alone.~      Gold standard for pleural tissue sampling is the surgical (VATS) thoracoscopy, allowing~     direct visual guiding of tissue sampling from all pleural surfaces. Yet, globally the medical~     (pleuroscopy) thoracoscopy is more widely used: cheaper, outpatient procedure, but allows~     only sampling from the parietal pleura. To date, no randomised studies have compared medical~     and surgical thoracoscopy concerning diagnostic hit rates, adverse events, or economics.~      The investigators will perform two randomized studies to investigate whether~        1. PET/CT is comparable to CT alone~        2. VATS is comparable to pleuroscopy concerning hit rate, total investigations performed,~          time-to-diagnosis.~   "
55966|NCT02834442|"~     The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of~     MT-7117 in healthy subjects.~   "
55967|NCT02834429|"~     The aim of this study is to assess the clinical utility of the whole blood~     transglutaminase-based rapid test against current serological tests and the gold standard of~     duodenal biopsy. The investigators will recruit patients (n=1000) from the endoscopy~     department at the Royal Hallamshire Hospital, Sheffield, United Kingdom (UK). The patients~     recruited for this study will already have been referred for a consultation and gastroscopy.~     In addition, these patients will already have been serologically tested for IgA TTG, EMA and~     a total IgA immunoglobulin level (as per normal clinical practice).~      All duodenal biopsy specimens will be fixed in buffered formalin and embedded in paraffin~     wax. Standard, 3μm thick sections at three levels will be stained with haematoxylin and eosin~     and reported routinely. Additionally, biopsies demonstrating increased intraepithelial~     lymphocytes only (changes compatible with but not diagnostic of coeliac disease) will be~     stained with KiRAS or CD4/CD8 which are markers for coeliac disease.~   "
55968|NCT02834416|"~     Prostate Cancer (PC) affects 1 in 7 men. Nearly half of those diagnosed with PC will receive~     androgen deprivation therapy (ADT) as part of their treatment. ADT is good at managing PC but~     has many side effects. Researchers have shown that exercise, specifically one-on-one~     supervised exercise improves many of the side effects of ADT. However, exercise programs for~     men on ADT are not widely available. More questions need to be answered in order for exercise~     programs to become part of PC treatment. First, can programs that require fewer resources,~     such as group-exercise or home-based exercise, also improve ADT side-effects? Second, do~     exercise-related benefits continue beyond the structured exercise program? And what makes~     people continue exercising? Third, which exercise program is most cost-effective?~      In this study, the investigators will compare: (a) group supervised in-centre and (b)~     home-based supported exercise programs to see which program is most effective for men with PC~     on ADT. The investigators will also look at what motivates people to continue to exercise~     both during a structured program and after the program is complete and will examine which~     exercise program is most cost-effective.~      Participants (men with PC on ADT) will be recruited from one of the following cancer centres:~     Princess Margaret Cancer Centre in Toronto, the Tom Baker Cancer Centre in Calgary, the~     Southlake Regional Health Centre in Newmarket, and Scarborough and Rouge Hospital - Centenary~     Site in Scarborough. When a patient agrees to participate, patient will be randomly placed in~     1 of 2 exercise programs. All programs will include the same type of exercises (aerobic,~     resistance and flexibility) and all participants will exercise 4-5 days per week for 30~     minutes per day (as tolerated) for the length of the program (6 months). The investigators~     will look at how men with PC on ADT respond to the exercise program by measuring quality of~     life (QOL), fatigue and different physical measures before, during, and after the exercise~     program.~      Although the investigators know that supervised one-on-one exercise is most effective at~     improving ADT side-effects, it is unknown if other forms of exercise are just as beneficial~     and more financially responsible. This study will allow the investigators to begin to answer~     these questions so that structured exercise programs become a regular part of PC treatment.~   "
55969|NCT02834403|"~     This is a Phase Ib/II study assessing the maximum tolerated dose (MTD), dose-limiting~     toxicities (DLTs), recommended Phase 2 dose (RP2D), and efficacy of L-NMMA when combined with~     docetaxel in refractory locally advanced or metastatic triple negative breast cancer~     patients. The Phase Ib portion of the study is designed to investigate the combination at two~     dose levels of docetaxel (75 and 100 mg/m2) and 7 dose levels of L-NMMA (5, 7.5, 10, 12.5,~     15, 17.5, and 20 mg/kg). The starting dose of L-NMMA will be 7.5 mg/kg. In the Phase II~     portion of the study, the starting dose will be the RP2D determined in the Phase Ib portion~     of the study.~   "
55970|NCT02834390|"~     This is a phase 1b, dose escalation, study of quizartinib to evaluate the safety profile, the~     pharmacokinetics, and the recommended dose of quizartinib for subsequent clinical studies of~     the combination of quizartinib and induction and consolidation chemotherapy.~   "
55971|NCT02834377|"~     The purpose of this study is to evaluate the effectiveness of using the personal~     preoperatively assessed cardiac output in high-risk patients to guide perioperative~     administration of fluids and vasoactive drugs on predefined postoperative complications.~   "
55972|NCT02834364|"~     Trial for patients with refractory multiple myeloma after failure of at least two treatment~     regimens and with BRAFV600E/K Mutation to evaluate the efficacy of the kinase inhibitors~     Encorafenib (LGX818 in) combination with Binimetinib (MEK162).~   "
55973|NCT02834351|"~     The purpose of this study is to evaluate the effect of muscle ischemia during claudication on~     mitochondrial function.~      Comparison to patients with arterial disease but absence of lower limb claudication (Cardiac~     group) feasibility study.~   "
55974|NCT02834338|"~     Randomized Controlled Trial to monitor and increase the postoperative mobilization of the~     patients undergoing major visceral surgery by giving a continuous autofeedback of the step~     count using activity tracking wristbands.~   "
55975|NCT02834325|"~     The purpose of the study was to describe early predictors and to develop a prediction tool~     that accurately identifies the need for mechanical ventilation in pneumonia patients with~     acute respiratory failure treated with High Flow nasal cannula.~   "
55977|NCT02834299|"~     This study will compare unguided and guided dialectical behavior therapy (DBT) self-help to~     an attention-placebo self-help control condition. Participants with binge eating disorder~     will be randomly assigned to one of the three self-help conditions for 12 weeks. Six guided~     self-help sessions will take place via secure video-calling. Assessments will take place~     before, mid-way through, and after the self-help program as well as at 3-month follow-up. Six~     guided self-help sessions will take place via secure video-calling.~   "
55978|NCT02834286|"~     The purpose of this study is to determine the response rate and response duration with the~     combination of low-dose rituximab, eltrombopag and high-dose dexamethasone.~   "
55979|NCT02834273|"~     The rapid diagnosis and treatment of acute ischemic stroke are critical in the reduction of~     morbidity, disability and stroke associated mortality Under-education about stroke may~     prevent people from recognizing symptoms early enough to seek immediate care.~      The studies reported on stroke patients managed in stroke center have shown that 39-42% of~     patients could not name any symptoms of stroke and 36% to 43% no risk factor of stroke.~      The stroke patients are therefore a population at high risk for neurological events and~     cardiac vascular recurrence. However, no studies have evaluated the interest of the~     development of therapeutic workshops in stroke unit to educate patients about symptoms~     suggestive of stroke, risk factors and what to do in cases of stroke.~      Investigators assume that the setting up of a therapeutic education workshop in the stroke~     unit may allow a better understanding of the symptoms, risk factors and what to do following~     stroke. So there is a direct benefit to the patient represented by a better knowledge of~     stroke (warning signs, risk factors, what to do), improved treatment compliance and reduced~     risk of recurrence.~      More generally, there is a real benefit to promote these messages to the public through the~     patient and his relatives~   "
55980|NCT02834260|"~     Immune rejection episodes after penetrating keratoplasty occur in 30% of patients and~     constitute one of the main factors reducing graft survival. They mainly occur during the~     first 18 months. Prevention usually relies on a topical treatment with dexamethasone or~     prednisolone for standard risk patients. Eye drops are instilled three times a day during at~     least 3 months then tapered.~      OZURDEX is an absorbable small implant that releases a total of 700 micrograms dexamethasone~     during several months. It is indicated for intravitreal injection to treat macular edema.~      The investigators hypothesized that this implant could be used after subconjunctival~     injection during corneal graft, to prevent immune rejection and avoid repeated eyedrop~     instillations.~   "
55981|NCT02834247|"~     The purpose of this study is to evaluate the maximum tolerated dose (MTD) or recommended~     Phase 2 dose (RP2D), safety and efficacy of TAK-659 in combination with nivolumab in~     participants with advanced solid tumors.~   "
55982|NCT02834234|"~     Peritoneal mesothelioma is a rare disease representing one third of all mesothelioma and~     nothing is known about molecular characteristics of this disease. As main cancers, genetic~     heterogeneity is probable. This genomic profiling associates Comparative Genomic~     Hybridization (CGH) array, BAP1 sequencing and gene expression in order to discover a~     biomarker that could be used in the treatment of this rare disease. Corresponding~     histopathological and immunohistochemical report as all clinical data are available. All data~     with be merged to underline a few genes of interest on which we will focus our next~     investigations. Depending of our preliminary results, BAP1 mutations are expected, as it was~     also described in pleural mesothelioma. Mutations in oncogenic drivers that could be targeted~     by specific therapy will be on particular interest in management of this rare disease with~     bad prognosis.~   "
55983|NCT02834221|"~     This study is designed to evaluate the use of real-time ultrasound-guided femoral~     venipuncture during pulmonary vein isolation for treating atrial fibrillation .~   "
55984|NCT02834208|"~     Schizophrenia is an invalidating psychiatric illness with a strong genetic component~     characterized by abnormal processing of emotional information. This alteration in emotion~     processing has been described in acute as well as in remission phases of the illness. It has~     also been found in healthy relatives of patients with schizophrenia and in subjects at high~     risk of psychosis. Thus, alterations in emotional information processing are not only linked~     to the prognosis but can also be considered as a marker of vulnerability of schizophrenia. In~     addition, schizophrenia patients differ from healthy controls in neural activity in brain~     regions implicated in emotions processing. However, interpretation of findings in patients is~     limited by confounding factors, such as antipsychotic treatments or alterations due to the~     course of illness. Also, there is no data concerning genetic factors (polymorphisms or gene~     expression) underlying these patterns of cerebral activation in emotion information~     processing.~      So, the main objective of this study is to compare the cerebral activity of schizophrenia~     patients to that of healthy siblings and healthy controls in an emotional processing task.~   "
55985|NCT02834195|"~     Cerebral palsy (CP) has been defined as a group of permanent disorders of the development of~     movement and posture causing activity limitation(s) that are attributed to non-progressive~     disturbances that occurred in the developing fetal or infant brain.~      Investigators previously developed two classification systems, one for the upper limb and one~     for the hand, based on 100 films of patients with cerebral palsy. Separate classifications~     were developed following an initial study in which investigators found no correlations~     between upper limb and hand patterns, meaning that specific upper limb patterns are not~     always associated with specific hand patterns. Thumb patterns were not included in these~     classifications since robust classifications already exist, moreover thumb patterns are~     independent from hand patterns.~      The aim is to evaluate the inter- and intra-rater reliability of two previously developed~     classifications of upper limb and hand patterns.~   "
55986|NCT02834182|"~     Theory of mind (TOM), a main component of social cognition processes, refers to the capacity~     to infer one's own and other person's mental states. Deficits in social cognition are found~     in patients with schizophrenia and bipolar disorder. The purpose of this study is to compare~     the neurofunctional profiles of schizophrenic patients, bipolar patients and healthy~     participants during the performance of a TOM task. Results may help to understand the neural~     bases of the impairments in social cognition in schizophrenia and bipolar disorder, which may~     in turn help to propose potential new psychosocial therapeutic approaches in these disorders.~   "
61083|NCT02767362|"~     This is a preoperative window, phase 0 study of short-term atorvastatin treatment in obese~     women who are to undergo surgical staging for endometrial cancer.~   "
55987|NCT02834169|"~     Despite advances in the management of and changes in clinical practice, little is known about~     the epidemiology, patterns of care and outcomes of rare peritoneal surface malignancies~     patients in France.~      In order to better understand the characteristics of rare peritoneal surface malignancies and~     to evaluate treatment strategies, the RENAPE registry aims at the collection of data from~     patients presenting with a rare peritoneal surface malignancy in France. Data will be entered~     prospectively in a specifically designed and secured web database.~      All RENAPE's centres and physicians are invited to register patients with a rare peritoneal~     surface malignancy diagnosis and to participate to the registry. Data will be evaluated~     within regular time frames, focusing on types of rare peritoneal surface malignancies,~     treatment modalities and patient outcomes (e.g. survival, recurrence), thereby contributing~     to the better understanding of these rare cancers.~   "
55988|NCT02834156|"~     This protocol is a pilot study on standard care. The main goal is to assess the impact of~     positioning on lumbar puncture process especially on pain sensitivity in children.~      It's a prospective, monocentric, randomized, open-label, cross-over study. Inclusion period~     is one year, and number of inclusions forecasted is about 30. Each patient will have one LP~     in a seated position and one in a lying position.~   "
55989|NCT02834143|"~     Chronic critical limb ischemia (CCI) is the most severe clinical form of occlusive arterial~     disease. Its prognosis is terrible, mortality estimated at 50% in five years. However there~     are no recent epidemiological data on morbidity and mortality of critical ischemia. Moreover,~     the diagnostic criteria of the ICC associate clinical and hemodynamic criteria and are not~     subject to a clear consensus.~      Investigators propose to evaluate the validated diagnostic criteria (TASC VALMI, European~     working group) in a population of severe ischemia in patients in order to offer relevant~     simple and reproducible criteria. Secondly Investigators propose to monitor the medium and~     long term evolution of these patients ICC defined to clarify the prognosis.~      diagnostic criteria of the different societies:~        -  TASC: Transatlantic criteria: very characteristic pain, wound optional, variable~          hemodynamic criteria as the presence of a wound or not~        -  VALMI: French criteria derived vascular medical college: characteristic pain, sore,~          hemodynamic reproducible, reliable criteria~        -  European working group: European definition of criteria, including a characteristic~          pain, requires no wound, different hemodynamic criteria of 2 others.~   "
55990|NCT02834130|"~     Severe forms of hemophilia and other constitutional bleeding disorders represent a group of~     rare diseases. In last decades, news therapies have dramatically increased life expectancy~     and joint's protection.~      The investigators propose to set up a single-centre, descriptive, transversal pilot study,~     designed for the inclusion of around thirty children from 2 to 10 years, with haemophilia or~     allied hereditary bleeding disorders (HBD), who were referred to the Hemophilia Treatment~     Center (HTC) of Marseille at diagnosis. For those children who were able to benefit from the~     totality or part of the device accompanying the diagnostic announcement in the past 10 years.~   "
55991|NCT02834117|"~     Embryo freezing is a technique used regularly to optimize the pregnancy rate in case of~     infertility. This method is performed in presence of supernumerary embryo(s) after fresh~     transfer, or after freeze all embryos in case of medical reasons. It is necessary to control~     that the transfer is performed when the endometrium is receptive, which is essential for~     embryo implantation and pregnancy. This period is defined as the implantation window.~     Endometrial preparation can be achieved by hormone replacement therapy (HRT) or moderate~     ovarian stimulation (SO). The implantation window can also be assessed by monitoring of a~     natural cycle (NC). The objectives of this open randomized study is to compare the number of~     visits (ultrasound and blood tests) induced by the SO or NC as well as the women quality of~     life in both groups.~   "
55992|NCT02834104|"~     Myocardial fibrosis is recognized as the pathologic entity of extracellular matrix~     remodeling. Diffuse, reactive fibrosis is increasingly recognized in a variety of conditions~     despite the absence of ischemia. Regardless of the etiology, fibrosis leads to increased~     myocardial stiffness thereby promoting cardiac dysfunction. This dysfunction may present~     clinically with symptoms of cardiac failure although this is often a subclinical disease.~     Various imaging modalities and collagen biomarkers have been used as surrogate markers to~     assess the presence, extent, and turnover of myocardial fibrosis. Techniques using~     echocardiography, cardiac magnetic resonance, and nuclear imaging have been developed to~     detect early features of systolic and diastolic left ventricular dysfunction and impaired~     contractile reserve. Further identification of diffuse reactive fibrosis may be possible with~     evolving cardiac magnetic resonance and molecular techniques. The goal of this protocol is to~     validate cardiac magnetic resonance imaging as a new tool for fibrosis quantification against~     histology as standard of reference.~   "
55993|NCT02834091|"~     The use of hypnosedation in the context of anesthesia is validated. This is a technique that~     combines the hypnosis procedure as intravenous sedation. For surgery, it is associated with~     local anesthesia surgical site. It can favorably replace general anesthesia if surgery or~     endoscopy allows but doctors will always need local anesthesia surgical site where surgery~     The hospital Paris Saint joseph introduced gradually this technique from first in 2007 to the~     operating room and in the various services of conventional and ambulatory hospitalizations.~      The goal of the investigators is to evaluate these parameters on a prospective cohort of~     patients supported by hypnosedation in Paris Saint Joseph hospital for an endoscopy or~     surgery.~   "
56002|NCT02833974|"~     This study will assess whether Toll like receptor 7 (TLR7)-mediated pharmacology, with~     intranasal (i.n.) GSK2245035 20 nanogram (ng) administered weekly for a period of 8 weeks,~     will lead to reduced allergic reactivity in the lower airways in subjects with mild allergic~     asthma.~      This will be a randomised, double-blind (sponsor open), placebo-controlled, parallel group,~     8-week treatment study.~      The study will consist of a screening period of up to approximately 4 weeks (involving two~     screening visits), a blinded treatment period of 8 weeks, followed by a follow-up period of~     up to 3 months. The total duration of the study for each subject will therefore be a maximum~     of approximately 6 months.~   "
56213|NCT02831192|"~     The purpose of this study is to see whether HLA-mismatched donor cells infusion with~     chemotherapy (microtransplantation，MST) could increase complete remission (CR) and improve~     survival in older patients with acute myeloid leukemia (AML)，the investigators conducted a~     prospective, multicenter clinical trial of HLA-mismatched MST to estimate outcomes and~     toxicities.~   "
55994|NCT02834078|"~     According to the International Diabetes Federation, one in every 12 individuals is a diabetic~     (about 8% of the world population). Major risk factors of diabetes are all the aspects of~     modern life which include obesity, over-weight, high-risk behavior like smoking, alcohol,~     multiple drug use-recreational or prescribed, environmental risk factors like inactivity and~     lack of exercise. However there is a window of opportunity between health and disease, which~     is pre-diabetes.~      Pre-diabetes has been defined by American Diabetes Association as Impaired Glucose Tolerance~     (IGT) which is 7.8 -11.0 mmol/l, Impaired Fasting Glucose Test (IFT) which is 5.6-6.9mmol/l~     and now added Glycosylated Hemoglobin (HbA1c) of 5.7% to 6.4%.~      Though there are plenty of drugs available for significantly impaired glucose metabolism~     (including oral hypoglycemic agents and insulin), their use in marginally impaired glucose~     metabolism is questionable due to risk of untoward hypoglycemia.~      On the other hand, herbal products like curcumin, as a single ingredient has poor~     bioavailability problem that restricts its use as standalone treatment. Inulin works as~     pre-biotic and help to maintain gut microbiota which is considered as precursor for progress~     of prediabetes to diabetes. However, it does not have any role in primary pathophysiology of~     impaired glucose metabolism, i.e. pancreatic β cell dysfunction, insulin resistance, hepatic~     gluconeogenesis or intestinal glucose absorption. Resveratrol and omega-3 basically work on~     anti-oxidant pathways.~      None of these popular ingredients has been studied for their role in structural and~     functional health of pancreatic β cells which is very important for prediction of further~     progress of marginally impaired glucose metabolism to significantly impaired glucose~     metabolism.~      It is an unmet need to develop a product which not only improves insulin sensitivity, but~     also help to preserve the structural and functional health of pancreatic β cells. It also~     needs to improve overall metabolic and endothelial health of the person considering the close~     association between impaired glucose metabolism and these parameters.~      The proposed supplement - Berberine GlucoGold - is an improved version of successfully~     marketed supplement - Berberine GlucoDefense. It has a balanced composition in which all the~     ingredients complement each other in such a way that along with the individual role in~     glucose metabolism it also takes care of overall bioavailability and stability of the~     supplement. As per the previous data on ingredients, the supplement is also expected to~     preserve the structural and functional health of pancreatic β cells. The ingredients are also~     known to have positive effect on overall metabolic and endothelial health. Thus BGG has been~     developed to address the unmet needs in the area of glucose metabolism and overall metabolic~     health.~   "
55995|NCT02834065|"~     In this study the investigator will randomize 273 subjects to deep (<20°C), low~     (20.1°C-24°C), or moderate (24.1°C-28°C) hypothermia during aortic arch surgery with~     circulatory arrest. The primary purpose of this study is to determine the effect of deep vs~     low vs moderate hypothermia on neurocognitive function, brain functional connectivity, and~     leukocyte SUMOylation patterns after surgical circulatory arrest in participants.~   "
55996|NCT02834052|"~     The main purpose of this study is to determine the dose of poly-ICLC that is safe and~     tolerable when it is combined with pembrolizumab in patients with colon cancer. This study~     will also evaluate how the combination of pembrolizumab and poly-ICLC activates the immune~     system in the patient's blood and inside the tumor; how it affects the size and number of~     tumor(s) in each patient; and how effective the combination is in patients with colon cancer~     that is unlikely to respond to pembrolizumab alone.~   "
55997|NCT02834039|"~     This study aims to compare the ventilation Distribution between tidal Volume 6ml/kgBW and~     tidal volume 10ml/kgBW in laparoscopic nephrectomy patients~   "
55998|NCT02834026|"~     Muscle strength can be measured by dynamometry, but the investigators did not find in the~     literature the study of this technique in the quadriceps of patients with chronic kidney~     disease on hemodialysis. Analyze training impact conducted by cycle ergometer in quadriceps~     muscle strength in patients with chronic kidney disease during hemodialysis. This study will~     be a prospective, randomized. Inclusion of 46 patients followed by the dialysis unit of a~     university hospital, over 18 years, of both genders who underwent hemodialysis for more than~     six months and signed the consent form and enlightened. Patients will be divided into two~     groups: Intervention (n = 23) and control (n = 23). All will be evaluated for demographics~     and quadriceps strength given by standardization of technique, with hard and windy belt. The~     control group will be reassessed after two months of the initial assessment, since the~     intervention group held two months of training in hemodialysis a physical therapy protocol~     with the cycle ergometer.~   "
55999|NCT02834013|"~     This clinical trial studies nivolumab and ipilimumab in treating patients with rare tumors.~     Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of~     tumor cells to grow and spread.~      This trial enrolls participants for the following cohorts based on condition:~        1. Epithelial tumors of nasal cavity, sinuses, nasopharynx: A) Squamous cell carcinoma with~          variants of nasal cavity, sinuses, and nasopharynx and trachea (excluding laryngeal,~          nasopharyngeal cancer [NPC], and squamous cell carcinoma of the head and neck [SCCHN])~          B) Adenocarcinoma and variants of nasal cavity, sinuses, and nasopharynx.~        2. Epithelial tumors of major salivary glands~        3. Salivary gland type tumors of head and neck, lip, esophagus, stomach, trachea and lung,~          breast and other location~        4. Undifferentiated carcinoma of gastrointestinal (GI) tract~        5. Adenocarcinoma with variants of small intestine~        6. Squamous cell carcinoma with variants of GI tract (stomach small intestine, colon,~          rectum, pancreas)~        7. Fibromixoma and low grade mucinous adenocarcinoma (pseudomixoma peritonei) of the~          appendix and ovary~        8. Rare pancreatic tumors including acinar cell carcinoma, mucinous cystadenocarcinoma or~          serous cystadenocarcinoma~        9. Intrahepatic Cholangiocarcinoma~       10. Extrahepatic cholangiocarcinoma and bile duct tumors~       11. Sarcomatoid carcinoma of lung~       12. Bronchoalveolar carcinoma lung. This condition is now also referred to as adenocarcinoma~          in situ, minimally invasive adenocarcinoma, lepidic predominant adenocarcinoma, or~          invasive mucinous adenocarcinoma.~       13. Non-epithelial tumors of the ovary: A) Germ cell tumor of ovary B) Mullerian mixed tumor~          and adenosarcoma~       14. Trophoblastic tumor: A) Choriocarcinoma~       15. Transitional cell carcinoma other than that of the renal, pelvis, ureter, or bladder~       16. Cell tumor of the testes and extragonadal germ tumors: A) Seminoma and testicular sex~          cord cancer B) Non seminomatous tumor C) Teratoma with malignant transformation~       17. Epithelial tumors of penis - squamous adenocarcinoma cell carcinoma with variants of~          penis~       18. Squamous cell carcinoma variants of the genitourinary (GU) system~       19. Spindle cell carcinoma of kidney, pelvis, ureter~       20. Adenocarcinoma with variants of GU system (excluding prostate cancer)~       21. Odontogenic malignant tumors~       22. Endocrine carcinoma of pancreas and digestive tract~       23. Neuroendocrine carcinoma including carcinoid of the lung~       24. Pheochromocytoma, malignant~       25. Paraganglioma~       26. Carcinomas of pituitary gland, thyroid gland parathyroid gland and adrenal cortex~       27. Desmoid tumors~       28. Peripheral nerve sheath tumors and NF1-related tumors~       29. Malignant giant cell tumors~       30. Chordoma~       31. Adrenal cortical tumors~       32. Tumor of unknown primary (Cancer of Unknown Primary; CuP)~       33. Not Otherwise Categorized (NOC) Rare Tumors [To obtain permission to enroll in the NOC~          cohort, contact: S1609SC@swog.org]~       34. Adenoid cystic carcinoma~       35. Vulvar cancer~       36. MetaPLASTIC carcinoma (of the breast)~       37. Gastrointestinal stromal tumor (GIST)~   "
56000|NCT02834000|"~     Continuous cardiovascular monitoring as part of management of high-risk surgical patients is~     widely practiced, however its role in low-risk surgical patients is unclear. Detailed~     monitoring of cardiovascular parameters from pre-induction stage allows clinicians to~     individualise anaesthetic management in the perioperative period. The investigators' aim was~     to investigate haemodynamic and Bispectral Index (BIS) changes in healthy patients undergoing~     surgery following induction of anaesthesia with propofol using a continuous non-invasive~     blood pressure device (LiDCOrapid™).~   "
56001|NCT02833987|"~     The purpose of this study is to determine whether use of direct oral anticoagulants (DOACs)~     is associated with an increased risk of major bleeding compared to warfarin use, for the~     treatment of venous thromboembolism (VTE).~      The investigators will carry out separate population based cohort studies using health~     administrative databases in eight jurisdictions in Canada, the UK and the US. Cohorts will be~     defined by the initiation of a DOAC or warfarin on or after January 1, 2009, with an incident~     diagnosis of VTE having occurred within 30 days prior to the date of the prescription for the~     DOAC or warfarin. Follow-up will continue until a hospitalization or emergency department~     visit for a major bleed. The results from separate sites will be combined to provide an~     overall assessment of the risk of major bleeding in DOAC users.~   "
56003|NCT02833961|"~     Cerebral vascular disorder is one of the most fatal diseases despite current advances in~     medical science. The large number of negative clinical trials on neuroprotection in acute~     stroke is a pointer to the fact that translating better understanding of the pathogenesis and~     pathophysiology to clearly beneficial treatment strategies remains a daunting task. This~     project aims at elucidating the plausible biophysical events that affect water and metabolite~     diffusion in brain tissue after ischemia, by combining the information provided by two~     advanced methods of magnetic resonance (MR) diffusion imaging: diffusional kurtosis imaging~     and diffusion-weighted spectroscopy.~      Diffusion weighted imaging (DWI) has been established as a major tool for the early detection~     of stroke. However, information obtained using conventional DWI may be incomplete.~     Diffusional kurtosis (K) is a quantitative measure of the complexity or heterogeneity of the~     microenvironment in white and grey matter, which offers complementary information and may~     potentially be a more sensitive biomarker for probing pathophysiological changes. In~     addition, to gain more specific insights into molecular mobility in the intracellular~     environment, it is beneficial to assess the diffusion properties of metabolites, such as~     N-acetylaspartate (NAA), creatine and phosphocreatine (Cr), and choline containing compounds~     (Cho). Assessment of metabolite diffusion changes by diffusion-weighted spectroscopy (DWS)~     provides information specific to the intracellular environment. In particular, thanks to the~     specific compartmentation of NAA almost exclusively in neurons and of Cho in glial cells, the~     diffusion properties of these metabolites may provide specific insights into the pathological~     processes occurring independently in the two cell types. In addition, measuring a temporal~     profile of diffusion coefficient of these compounds may help clarify underlying~     pathophysiological changes in neuronal cells during acute ischemia.~      With the help of these two advanced methods, a proof-of-concept trial is proposed on 24~     healthy subjects and 24 ischemic stroke patients. Ischemic stroke patients will be scanned~     three times with a 3T MR scanner (before day 10 post-stroke, around week 4 and 3 months), in~     order to extract diffusion kurtosis imaging (DKI) and DWS metrics and understand the dynamics~     of the cellular mechanisms at play in cerebral ischemia. The goal of this study is to~     investigate neuronal and glial metabolite diffusion changes at different time points after~     ischemic stroke, in both infarcted and non-infarcted hemispheres. The aim is to get~     non-invasively important information on the evolution of the cellular damage in this disease,~     and possibly distinguishing between neuronal and glial processes (by measuring the metrics~     extracted for these two sequences), as well as on the different mechanisms leading to~     metabolite diffusion changes in the two brain areas, thus providing a great impact on the~     strategy of treatment for patients with cerebral infarction.~   "
56004|NCT02833948|"~     The aortic valve is located between the left ventricle and the aorta. Patients with~     symptomatic, severe aortic valve stenosis conventionally have it surgically replaced~     requiring direct access to the heart through the chest. Transcatheter aortic valve~     replacement (TAVR) is now a well-established alternative for treating severe aortic valve~     stenosis. Both types of intervention improve prognosis and alleviate symptoms.~      The optimal choice of blood thinning therapy after TAVR is unknown. It has been reported that~     leaflet thrombosis with reduced leaflet motion can occur and this phenomenon has been~     suggested to be potentially related with neurological events. In addition, the occurence of~     this phenomenon can be reduced with anticoagulation blood thinning therapy.~      The purpose of this study is to evaluate if anticoagulation compared to the usual double~     platelet inhibitor therapy after TAVR can reduce the risk of leaflet thrombosis.~   "
56005|NCT02833935|"~     Pilot randomized controlled trial evaluating a Self-Determination Theory (SDT) video-based~     tele-rehabilitation physical activity intervention aimed to enhance basic psychological~     needs, motivation, physical activity (PA), and quality of life- related outcomes of adults~     with spinal cord injury (SCI). It is anticipated that the individuals who receive the~     physical activity intervention (intervention group) will have moderate increases in their~     basic psychological needs, autonomous motivation, life satisfaction, and physical activity~     participation, and a moderate decrease in controlled motivation and depressive symptoms~     compared to the individuals who did not receive the intervention (control group).~   "
56006|NCT02833922|"~     The purpose of this study is to assess the effectiveness and efficacy of Dynamic Optimal~     Timing (DOT), an app-based method of family planning that can be used via Android devices,~     for women who use the method to avoid pregnancy.~   "
56007|NCT02833909|"~     The objective is to investigate ex vivo the inflammatory response in hidradenitis suppurativa~     (HS) (activation of an inflammasome, role of pro-inflammatory cytokines) in the skin of~     patients treated surgically for this disease.~      The investigators hypothesize that Th17-derived cytokines, especially Interleukin (IL) IL-17,~     could serve as a relay in the inflammatory process leading to HS severity and recurrences.~   "
56008|NCT02833896|"~     Medical context:~      Several molecular studies showed chromosomal alterations in patients with endometrial cancer,~     with gains in 1q, 19p, 19q, 8q, 10q and 10p and loss of 4q, 16q and 18q. Several genes of~     interest have been dentified (P53, PTEN, PIK3CA, ß-catenin, K-ras ...). It is thus~     conceivable that like that enable genomic tools used in breast cancer today (Oncotype DX,~     MammaPrint), correlation between the tumor profile and life project in the case of cancer the~     endometrium could be done. A study is already underway at the Reims University Hospital with~     funding from the League against cancer and AOL in 2010 CHU Reims. It should identify the~     specific alterations of nosologic continuum of pathology and characterize areas of interest~     on the genome. To date, 39 patients with endometrial cancer and 15 patients with endometrial~     hyperplasia (patients 'cases') were included in the study. For this study, 10 patients~     exhibiting neither cancer nor endometrial hyperplasia were also included. Samples of these 10~     patients 'witnesses' were pooled to serve as a reference for analyzing patients 'cases'.~      objectives: In continuation of the study began in November 2009, refine the study of genomic~     imbalances highlighted hyperplasia and endometrial cancer by studying the in correlation~     between genomics and proteomics by immunohistochemical studies and analyzing the~     microsatellite instability.~      To study the prognostic role of genetic factors in patients carriers of a disease endometrial~     (cancer or hyperplasia).~      Material and methods :~      Experimental Design: Cross-sectional study in inclusion prospective multi-center followed by~     a cohort study of patients 'cases'.~      Population / patients: in total, it is planned to include 72 patients with hyperplasia or~     endometrial cancer (22 patients included in the pre-study part funded by the League against~     cancer 50 patients included in the scope of the study funded by the 2010 AOL Chu Reims).~      Plan of investigation: the study includes two phases:~      Sectional study:~      The inclusion of 10 patients witnesses has already been completed in the first project.~      During the consultation in the obstetrics and gynecology department of the Reims University~     Hospital and the surgical department of the institute Jean Godinot, terms and objectives of~     the study have been and will be presented to patients where cancer or hyperplasia endometrial~     was diagnosed by achieving endometrial biopsy.~      If the patient agrees to participate in the study, the management of its pathology~     (hysterectomy, hysteroscopy and curettage resection) will not be changed.~      The samples taken during the surgery were analyzed and will be as provided in the first~     research project. Tumor karyotype, DNA extraction are performed on each sample fresh. A~     comparative genomic hybridization is conducted using the DNAs thus obtained.~      Additional analyzes (immunohistochemistry and analysis of microsatellite instability) will be~     performed on all samples already obtained and on future withdrawals.~   "
56009|NCT02833883|"~     The main purpose of this study to define the good and/or bad effects of the combination of~     enzalutamide and CC-115 in patients with castration-resistant prostate cancer.~   "
56010|NCT02833870|"~     Cares of Alzheimer's disease (AD) and related disorders are presenting a real public health~     challenge. Because of the limited effectiveness of pharmacological treatments, there is a~     growing interest in care approach based on nonpharmacological treatments, such as musical~     interventions. Several lines of evidence suggest that musical interventions could improve~     behaviour, emotion and even cognition in patients with AD. However, very few studies respond~     to the methodological constraints required for clinical controlled trials carried out in well~     selected groups of patients. The efficiency of such care approaches is not scientifically~     proved yet and the impact of musical interventions has rarely been compared to another~     pleasant intervention, leaving open the question about the specific benefits of music in~     patients with dementia. The main goal of this research project is to demonstrate short and~     longer-term efficiencies and the specificity of musical interventions in dementia by~     investigating their effects not only in patients but also in familial and professional~     caregivers.~   "
56012|NCT02833844|"~     The study is divided into 2 parts. The first part of the study will be double-blinded and~     will last for 24 weeks. During this time, subjects will be randomized in a ratio of 2:1 to~     receive either Repatha (evolocumab) QM or placebo QM.~      The second part of the study is a 24-week open label extension period. During this time all~     subjects will receive Repatha (evolocumab) QM.~      The clinical hypothesis is that subcutaneous Repatha (evolocumab) QM will be well tolerated~     and will result in greater reduction of LDL-C, defined as percent change from baseline at~     week 24, compared with placebo QM in HIV-positive subjects with hyperlipidemia or mixed~     dyslipidemia.~   "
56013|NCT02833831|"~     The primary objective of this study is to evaluate the effect of supratherapeutic exposures~     of ALS-008176 on the QT/ corrected QT interval (QTc) interval in healthy participants (Panel~     2).~   "
56014|NCT02833818|"~     There are few scientific reports on preterm infants with birth weights between 1500 and~     2000g. Adequate and properly balanced supply of nutrients believed to better growth and~     cognitive development in this patient group, and optimized nutrition is an important part of~     treatment There is a need for more studies that can provide knowledge of growth and weight~     development in preterm and small for gestational age (SGA) infants with a birth weight~     between 1500 and 2000g.~   "
56015|NCT02833805|"~     Our primary objective is to determine if it is feasible for previously untreated severe~     aplastic anemia (SAA) patients to be transplanted using non-myeloablative conditioning and~     post transplantation cyclophosphamide.~   "
56016|NCT02833792|"~     STUDY OBJECTIVES~      Primary:~      To assess the safety and tolerability of ischemia-tolerant allogeneic human mesenchymal stem~     cells (hMSCs) manufactured by Stemedica versus placebo administered intravenously to subjects~     with mild to moderate dementia due to Alzheimer's disease.~      Secondary:~      To assess the preliminary efficacy of hMSCs versus placebo in subjects with~     Alzheimer's-related dementia, as evidenced by neurologic, functional, and psychiatric~     endpoints.~   "
56017|NCT02833779|"~     Pathology of the rotator cuff and subacromial bursa is considered to be the principal cause~     of pain and symptoms arising from the shoulder. Physiotherapy specialists often disagree~     about which type of exercise is most appropriate. Manual Physiotherapy combined with guided~     exercise is a commonly applied clinical treatment, but no proof of its effectiveness has been~     shown. Clinical trials comparing results of treating subacromial syndrome of the shoulder~     with guided self-treatment and conventional physiotherapy yielded a slightly higher~     improvement, basically because patients suffered from chronic tendinitis and the treatment~     period lasted only two weeks. That is the reason why the investigators propose a long-term~     follow-up study and a more complete assessment of effectiveness of the exercise prescribed to~     improved this pathology.~      Objectives:~        -  Assessment of effectiveness of two different types of treatment of subacromial syndrome~          of the shoulder.~        -  Comparison of effectiveness of both treatments in order to select that one yielding~          better results as the one to be applied as a routine practice.~      Patients will be assigned one of the following treatments:~        -  Group 1: patients will be taught exercises in groups of six people, on a daily basis for~          twelve sessions.~        -  Group 2: patients will be taught the same exercise as Group 1, individually, and will~          receive manual therapy consisting of muscular and joint re-centering.~      A modified version of the Constant scale will be used to assess mobility and pain shoulder.~   "
56018|NCT02833766|"~     The main objective of the trial is to determine the efficacy of doxorubicin-loaded anti-EGFR~     immunoliposomes as first-line therapy in patients with advanced triple Negative, EGFR~     positive breast cancer. In this proof of concept trial, all patients will have an~     administration of the doxorubicin-loaded anti-EGFR immunoliposomes (anti-EGFR-IL-dox) every~     28 days, until progression or unacceptable toxicity.~   "
56019|NCT02833753|"~     This is a Phase I dose escalation study to determine how much chemotherapy can be safely~     administered into the abdomen while experiencing the fewest possible side effects.~   "
56020|NCT02833740|"~     The Click-Mid-Upper Arm Circumference study aims to describe and compare the performance of a~     set of three simplified mid-upper arm circumference classification devices (Click-MUAC) for~     use by mothers and caregivers to screen for acute malnutrition in young children. The study~     will be conducted in Isiolo County, Kenya. The study builds on the recent approach of~     training mothers to screen for acute malnutrition in their own children (mother MUAC~     approach).~      The primary aim of the study is to describe and compare the performance of a set of three~     prototype Click-MUAC devices against a gold standard of classification, in terms of measures~     of agreement (sensitivity, specificity, accuracy, Cohen's Kappa, Youden's J) for the~     classification (diagnosis) of acute malnutrition. A secondary aim of the study is to~     determine the difference in agreement with the gold standard classification amongst~     mothers/caregivers using a Click-MUAC prototype versus mothers/caregivers using a regular~     MUAC tape. The hypothesis of the study is that at least one of the Click-MUAC prototypes is~     equal to the gold standard of classification in terms of measures of agreement for the~     classification of acute malnutrition. A secondary hypothesis of the study is that agreement~     with the gold standard classification is better amongst mothers/caregivers using a Click-MUAC~     prototype compared to mothers/caregivers using a regular MUAC tape. The outcomes of the study~     will be used to decide on whether production of a Click-MUAC device is desirable and, if this~     is the case, to select a design based on the performance of the prototype devices and the~     stated preferences of intended users.~   "
56033|NCT02833558|"~     Endoscopic submucosal dissection (ESD) is an endoscopic resection technique used to treat~     superficial neoplasia in the gastrointestinal tract. Bleeding is a commonly encountered~     problem during submucosal dissection and is usually managed with electrocautery. However,~     this does carry a risk of deep thermal injury and perforation.~      PuraStat® is a novel extracellular scaffold matrix of amino acids that forms a transparent~     adherent barrier when applied to a bleeding point.~      The aim of this trial is to study the use of PuraStat® in reducing the need for thermal~     haemostasis during ESD.~   "
56034|NCT02833545|"~     Prospective, Interventional, Non-Randomized, Open Label, Single Group Assignment, Single~     Center.~   "
56035|NCT02833532|"~     The purpose of this study is to evaluate non-inferial study of the after using Volus~     application, compared to the powerfill.~   "
57342|NCT02816437|"~     This is a pilot feasibility study to determine whether fecal microbiota transplantation (FMT)~     can suppress or reverse gastrointestinal carriage of MDROs in hospitalized solid organ~     transplant recipients with a history of one or more MDRO infections.~   "
56021|NCT02833727|"~     Aim : To compare, among patients with an uncontrolled moderate to severe asthma, the blood~     eosinophil levels of smokers and non-smokers.~      Secondary aims: In uncontrolled moderate to severe asthmatic subjects, to compare between~     asthmatic smokers and non-smokers: sputum eosinophils counts, fractional exhaled nitric oxide~     (FeNO), pre and post bronchodilator Forced expiratory volume in one second (FEV1) / Forced~     vital capacity (FVC), Asthma-related quality of life, asthma exacerbations during the year~     preceding enrolment in the study, Medical direct and indirect costs related to asthma during~     the year preceding enrolment in the study, and adherence to asthma treatment during the year~     preceding enrolment in the study.~      Methods: Cross sectional observational study. Never-smoker and smoker asthmatics treated with~     at least 2 controller medications with a smoking history ≥10 pack/year with a ACQ score ≥ 1.5~     points will be identified in the database RESP. Their clinical data will be matched to the~     Régie de l'assurance médicale du Quebec (RAMQ) and Maintenance et exploitation des données~     pour l'étude de la clientèle hospitalière (MED-ECHO) administrative databases and reMed (data~     on medications for patients with private health insurance) in order to access to data on~     medical services, hospitalisations and medications delivered by pharmacies. T~   "
56022|NCT02833714|"~     The purpose of this research is to characterize the effect of teriflunomide on the activation~     of B-cells, as well as its capacity to modify B-cell cytokine secretion. The in-vitro~     identified effects of teriflunomide on the expression of B-cell activation markers,~     costimulatory and antigen presenting molecules, as well as on cytokine secretion, will then~     be confirmed in a cohort of Relapsing Remitting Multiple Sclerosis (RRMS) patients treated~     with this medication.~   "
56023|NCT02833701|"~     This phase I trial studies the side effects and best dose of ascorbic acid when given~     together with bevacizumab in treating patients with high grade glioma that has come back~     (recurrent). Monoclonal antibodies, such as bevacizumab may interfere with the ability of~     tumor cells to grow and spread. Ascorbic acid contains ingredients that may prevent or slow~     the growth of high grade glioma. Giving bevacizumab and ascorbic acid together may work~     better in treating patients with high grade glioma.~   "
56024|NCT02833688|"~     To investigate whether dexmedetomidine reduce liver injury after hepatectomy. During~     hepatectomy, surgeons always took inflow occlusion to reduce blood loss with Pringle~     maneuver. A few clinical studies had shown dexmedetomidine could reduce ischaemia/reperfusion~     (IR) injury caused by the secretion of reactive oxygen species and inflammatory cytokines.~     Glutathione-S-transferase (GST) was a sensitive and specific marker for hepatic injury in~     several studies before. So the investigator decided to use it as the primary endpoint.~     Besides, in our center, there are some liver resection surgeries that didn't need occlusion.~     So it can serve the best placebo for determine the the actual effect of dexmedetomidine on~     the IR injury in further subgroup analysis.~   "
56025|NCT02833675|"~     Diagnosis of angioedema (AE) is difficult especially in emergency room. Two forms should be~     evoked: histaminic AE (allergic or not, which represent 95% of cases) and bradykinic AE~     (hereditary or acquired deficiency, with or without C1 Inhibitor) rarer but with more severe~     prognosis. The distinction is based on clinical features (spontaneous crisis duration,~     presence of concomitant hives, atopic history...). Sometimes it could be difficult to make~     the difference. Nowadays, there is no biological marker of the crisis. The search for~     biomarkers could improve the diagnostic and therapeutic management of AE. Previous work has~     identified targets: D-dimer, C4, and VE-cadherin. We wanted to know the sensitivity and~     specificity of these markers.~      We conducted a prospective study evaluating the D-dimer assays, complement and VE-cadherin~     during an episode of AE. Three groups of patients were tested: bradykinic AE (peripheral or~     abdominal attacks), histaminic AE, and abdominal pain (non-bradykinic and non-histaminic~     etiology) at the time (day 0) and at distance from the crisis (D7).~   "
56026|NCT02833662|"~     Higher risk of cardiac and respiratory post-operative events is observed in patients with~     unrecognised Obstructive Sleep Apnea (OSA). The efficiency of a simple method of OSA~     screening by analysing ventilation with measurement of nose pressure and nocturnal hypoxemia~     (oxygen desaturation index) will be assessed. These sleep respiratory analyses will be~     compared with the research of arrhythmia, in order to show if they are linked to the~     hypoxemia events.~      Aggravation of nocturnal respiratory disorder and higher incidence of cardiac and respiratory~     postoperative complications will be assessed in OSA patients.~   "
56027|NCT02833649|"~     To report on 4-year postoperative safety, efficacy, stability and predictability outcomes(to~     evaluate the visual, refractive, contrast sensitivity, defocus curve and aberrometric data~     preoperation, and compare with a similar postoperative outcomes) with the Toric Implantable~     Contact Lens (TICL) for Stable keratoconus. Investigators will study the four-year follow-up~     from this standardized, multi-center clinical investigation, support from clinical and~     optical viewpoints TICL implantation, in stable keratoconus.~   "
56028|NCT02833636|"~     The age, creatinine, and ejection fraction (ACEF) score has been used to evaluate the~     clinical prognostic to patients who underwent PCI. However, it is not known if ACEF score~     could evaluate the prognostic of recanalization of non-infarct-related coronary arteries~     (non-IRA) chronic total occlusions (CTO) in patients who successful underwent primary PCI.~     The objectivity of current study was to assess the prognostic value of ACEF score in acute~     ST-segment elevation myocardial infarction (STEMI) patients with non-IRA CTO after successful~     primary PCI.~   "
56029|NCT02833623|"~     Helicobacter pylori (H. pylori) is a pathogen that infects more than 50% of the human~     population, resulting in high healthcare costs worldwide. However, H. pylori eradication rate~     is low nowadays and patients's compliance is one of the most important effective factors.~   "
56030|NCT02833610|"~     This research study is studying a possible therapy as a possible treatment for the~     consequences of Multiple Myeloma with renal insufficiency.~   "
56031|NCT02833597|"~     Check the feasibility of the collection of reliable measures of tcpO2 the lower limbs in~     arteriopathy when performing rowing on effort.~   "
56032|NCT02833584|"~     The purpose of this study is to determine whether regular dosage of paracetamol causes~     transaminitis (hepatitis) and evaluate its potency in the treatment of dengue infection.~   "
56108|NCT02832570|"~     Efffect of a single dose oral intake of sildenafil Or placebo on the walking capacity on~     treadmill of PAD patients with claudication~   "
56036|NCT02833519|"~     The purpose of this study is to examine the effect of supervised group exercise on mental~     wellbeing and signs of depression among pregnant women at risk of perinatal depression in a~     randomized controlled clinical trial.~      The investigators hypothesis is that 70 minutes of supervised group exercise twice a week for~     12 weeks by pregnant women at risk of perinatal depression, will improve the participants~     mental wellbeing and reduce their symptoms of depression.~   "
56037|NCT02833506|"~     This phase I clinical trial studies the side effects of sirolimus and NY-ESO-1 protein with~     MIS416 in treating patients stage II-IV ovarian, fallopian tube, or primary peritoneal~     cancer. Sirolimus may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Vaccine therapy, like Y-ESO-1 protein with MIS416, may strengthen the immune~     system to find and kill tumor cells. Biological therapies, such as sirolimus, use substances~     made from living organisms that may stimulate or suppress the immune system in different ways~     and stop tumor cells from growing. Giving sirolimus and vaccine therapy may work betting in~     treating patients with ovarian, fallopian tube or primary peritoneal cancer.~   "
56038|NCT02833493|"~     The investigators aim to give an overview of Iron overload(IOL) of patients with AA and low~     and int-1 risk MDS and their sequelae under different chelation treatment. And the~     investigators also aim to evaluate the relationship of LIC and T2*/R2*.~   "
56039|NCT02833480|"~     This study will evaluate the effects of budesonide (using Symbicort which is budesonide and~     formoterol) and fluticasone (using Advair which is fluticasone and salmeterol) on the airway~     microorganisms of patients with moderate-to-severe chronic obstructive pulmonary disease~     (COPD). This is a randomized, parallel group, two-centered clinical trial study to evaluate~     the effects of a 12 week treatment with Symbicort 400 mcg BID and Advair 250 mcg BID (via~     Diskus) on airway microbiota in patients with moderate-to-severe COPD. The control arm of~     this study will be Oxeze 12 ug BID.~   "
56040|NCT02833467|"~     Targeted next generation sequencing (NGS) provides a promising method for diagnostic purposes~     by enabling the simultaneous detection of multiple gene mutations. This study is to evaluate~     the feasibility and application value by using NGS into identifying genomic mutations in~     multiple or multifocal primary lung cancers in cell-tumor DNA (ctDNA) from surgical patients~   "
56041|NCT02833454|"~     The purpose of the study is to study the effect of anatomical direct insertion ACL~     reconstruction compared with conventional anatomical ACL reconstruction.~   "
56042|NCT02833441|"~     Youth with evidence of virologic failure defined as an HIV VL>400 copies/mL on two~     consecutive occasions at least 1 month apart will be eligible for enrollment. Youth will be~     randomized to a community based peer counseling support group or clinic based standard of~     care, with viral load, and drug monitoring evaluations at 3 month intervals to determine the~     efficacy of the intervention in improving adherence and virologic suppression.~   "
56043|NCT02833428|"~     The aim of this study was to analyze using an artificial intelligence engine (IA) the~     influence of the pathophysiological environment (set parametric monitoring data, imaging,~     biology etc.) of acute spinal cord trauma on spinal pain. This project seeks to establish the~     principles of a new approach for studying spinal cord injury patients. It does not meet the~     usual criteria of clinical trials in so far as it does not test on patients the effect of a~     therapeutic~   "
56044|NCT02833415|"~     This study is a clinical study to investigate the gluconeogenesis pathway related to visceral~     adipose tissue (VAT) in obese individuals without type 2 diabetes and the effects of~     empagliflozin (EMPA) on glucose homeostasis in viscerally-obese individuals using functional~     studies of glycerol metabolism in hepatic gluconeogenesis using a well-validated nuclear~     magnetic resonance (NMR) spectroscopy platform.~   "
56045|NCT02833402|"~     Sacral neuromodulation (SNM) which is approved as a treatment for men and women with urgency~     urinary incontinence (UUI), urgency frequency syndrome, urinary retention and anal~     incontinence, is a procedure designed to deliver electrical pulses to the sacral nerves,~     thereby influencing the bladder, sphincters, and pelvic floor. Although the success rates of~     this treatment are quite high, the precise mechanism of action of SNM in subjects with UUI~     remains unclear. Moreover, there are little data regarding specific patient characteristics~     that may serve as predictors for SNM success. Recent studies suggest that the bacterial~     community that lives in the urinary tract plays a role in the development and continuation of~     urinary symptoms. It is proposed that the urinary microbiome may change in women before and~     after SNM implantation and this study aims to describe these changes. Investigators in this~     study also hope to determine if differences in the urinary microbiome exist in women with a~     positive response to SNM treatment (responders) compared to those without symptom improvement~     (non-responders). This hypothesis will be tested by collecting urine samples as well as~     questionnaire and medical data from subjects with UUI that are already planning on undergoing~     SNM as part of clinical care before and after their SNM treatment.~   "
56046|NCT02833389|"~     This trial will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of~     repeat dosing of UTTR1147A in participants with neuropathic diabetic foot ulcers that do not~     respond adequately to standard wound care. Participants across multiple sites will be~     assigned to one of five cohorts (Cohort A, B, C, D, and E) based on the eligibility criteria~     and randomized to receive subcutaneous (SC) injections of either UTTR1147A or placebo over 12~     weeks in addition to standard wound care.~   "
56047|NCT02833376|"~     Context: The neuraxial blocks, spinal anesthesia and epidural anesthesia are among the most~     frequently performed procedures worldwide, and despite the advancements of medical equipment,~     remain dependent on experience and practice of the anesthesiologists. Although antisepsis~     takes part of the daily routine, there are still no solid scientific evidence of the most~     appropriate antiseptic for these procedures.~      Objective: To compare the 70% alcohol and 0.5% chlorhexidine alcohol solution in skin~     antisepsis for the neuraxial blocks.~      Methods: This is a clinical trial, a prospective, randomized study. There will be selected,~     consecutively, 70 patients candidates for neuraxial blocks. Patients will be randomly~     assigned to group A (n = 35), in which the antisepsis will be performed with alcohol 70%, and~     to group B (n = 35), in which the antiseptic will be performed with the 0.5% chlorhexidine in~     alcoholic solution. Samples will be collected with swabs in an area of 25 cm² for bacterial~     cultures three times: in pre-antisepsis moments, in the second minute after antisepsis, and~     immediately after the puncture. The number of colonies forming units per square centimeter~     (CFU / cm²) will be counted. The data will be analyzed statistically.~   "
56048|NCT02833363|"~     Helicobater pylori plays an important role in the development of gastric cancer. Eradication~     therapy can reducing the morbidity of gastric cancer, but can't totally prevent it especially~     when atrophy and more serious precancerous lesions already happened. Prior studies found the~     gastric bacterial difference among gastritis, intestinal metaplasia and gastric cancer.~     However, they didn't reach an agreement. Correa's model is widely accepted in the development~     of gastric cancer. The pathological change makes a more suitable environment for bacteria to~     overgrowth. This study are designed to analyze the gastric microbial difference of~     non-atrophic gastritis, atrophic gastritis, intestinal metaplasia, intraepithelial neoplasia~     and gastric cancer.~   "
56049|NCT02833350|"~     This is a multicenter, Phase II, randomized, double-blind, placebo-controlled, active~     comparator (Cohort 1 only), parallel-group, dose-ranging study to evaluate the efficacy and~     safety of GDC-0853 in participants with moderate to severe active RA and an inadequate~     response to previous methotrexate (MTX) therapy (Cohort 1) or MTX and tumor necrosis factor~     (TNF) therapy who may have also had exposure to no more than one non-TNF inhibitor biologic~     (Cohort 2).~   "
56050|NCT02833337|"~     Overcoming the vertical and horizontal bone deficiency in the posterior maxillae are~     considered as the most challenging scenarios for implant-supported oral rehabilitation in~     modern implant dentistry. Therefore, a comprehensive and precise understanding of such~     anatomical structures are needed to avoid potential complications that ultimately might~     jeopardize the treatment outcome.~      Cone-beam computerized tomography (CBCT) offers some advantages to conventional CT-scan such~     as lower-dose radiation with high isotropic spatial resolution and cost. Therefore, it offers~     a viable and reliable tool to study anatomical structures such as the posterior atrophic~     maxillae~   "
56051|NCT02833324|"~     This trial will investigate whether using reminder alarms with a wireless activity tracking~     device (Fitbit) will increase daily ambulation in individuals who have just had colorectal~     surgery.~   "
56052|NCT02833311|"~     Maintaining a healthy diet and engaging in routine physical activity may help decrease~     severity of symptoms, prevent secondary conditions, and slow functional decline in people~     with disabling neuromusculoskeletal conditions. However, people with these conditions face~     many health barriers to engaging in healthy behaviors. With the advent of portable~     technologies, such as smart phones, tablets and PDAs, there is a need to explore whether~     these technologies can help people with disabling conditions to stay motivated and overcome~     barriers to engaging in healthy behaviors.~   "
56053|NCT02833298|"~     Approximately half of the patients receiving treatment for chronic hepatitis C virus (HCV)~     infection in the United States have advanced liver disease. Patients with advanced~     fibrosis/cirrhosis who achieve a sustained virological response (SVR) to treatment and are~     clinically cured of HCV continue to have an elevated risk of developing hepatocellular~     carcinoma (HCC). According to guidelines from several professional societies and from the~     American Association for the Study of Liver Diseases (AASLD), in particular, patients with~     advanced fibrosis/cirrhosis should undergo life-long bi-annual screening for incident HCC~     whether they achieve an SVR, or not. The number of patients who need post-SVR HCC screening~     has risen dramatically in recent years due to the confluence of three factors: Increased~     screening for HCV, which has allowed more people to realize that they have this often~     silent infection; the availability of safe and highly effective direct acting antiviral~     drugs (DAAs) for HCV, which has allowed a much higher percentage of treated patients to~     achieve an SVR; and the long duration of HCV infection in many patients, which has allowed~     enough time for advanced fibrosis/cirrhosis to develop. To investigate post-SVR patients in~     the era of DAAs and to promote HCC screening, the objective of this study is to conduct a~     randomized, unblinded, two-arm prospective intervention trial comparing rates of HCC~     screening between patients randomized to either personalized patient navigation or automated~     reminders (e.g. electronic or mailed). Both interventions represent improved care over~     current standard of care (no patient navigation or automated reminders). There is no evidence~     to suggest one intervention is better than the other. Healthcare providers who agree to~     participate in the study will be contacted to confirm the liver disease status of their~     patients and during the clinical trial the providers of patients in both arms of the trial~     will be sent reminders about the need to schedule patients for screening visits.~   "
56054|NCT02833285|"~     The inflammatory response involves many players from the immune response, including B~     lymphocytes. These cells are responsible for the synthesis of immunoglobulins in response to~     the presence of an antigen. They are characteristic of chronic inflammation. There are~     several subsets of B cells characterized by specific membrane markers. Once activated, these~     cells express many factors contributing to tissue destruction seen in periodontitis and~     particularly in osteoclastogenesis (receptor activator of nuclear factor kappa-B ligand,~     tumor necrosis factor, interleukin-6, macrophage inflammatory protein-1α and Monocyte~     Chemoattractant Protein-3).~      During the establishment of a periodontal disease, an important inflammatory infiltrate is~     observed in the gum. This infiltrate is characterized by the presence of many B lymphocytes.~     B cell subsets in the blood and the gum of patients with periodontitis have been little~     studied. However, the number of autoreactive B cells (cluster of differentiation (CD)19+,~     CD5+) has been reported to be higher in the blood of patients with periodontal disease. In~     the gum, the rate of B and T cells increases with the level of inflammation and is correlated~     with the severity of the inflammatory process. Activation of B cells is a prerequisite for~     the progression of gingivitis to periodontitis. B cell distribution could then be an~     indicator of disease progression, but also allow to study the response to treatment.~      The aim of this pilot study is to characterize B cell subsets in the blood and the gum of~     patients with periodontitis, according to disease activity. Analysis of B cells in the blood~     could highlight the association of a particular subpopulation with aggressive periodontal~     disease and evidence a particular biological profile of the host response. The investigators~     also wish to observe the evolution of this phenotype following an unconventional surgical~     therapy.~      This study would better understand the pathogenesis of periodontal disease and refine the~     diagnosis, prognosis and treatment of periodontitis, and thus participate in the development~     of personalized medicine. Biological monitoring of therapeutic effects may be initiated and~     allow more effectively prevent recurrence.~   "
56055|NCT02833272|"~     Inappropriate medication use among the elderly ranges from 11% to 62% and is a major concern~     for patient safety. Benzodiazepines account for approximately 20 to 25% of inappropriate~     medications prescribed to the elderly, thus reducing their inappropriate use could have a~     substantial impact on patient safety and overall well-being among elderly patients. The~     Choosing Wisely Canada- Geriatrics guidelines for high value health care recommend against~     the prescription of benzodiazepines or other sedative-hypnotics (Z drugs) in older adults as~     first choice for insomnia, agitation or delirium. Despite evidence of potential harms,~     benzodiazepines and non-benzodiazepine sedatives (including the Z-drugs: eszopiclone,~     zopiclone, zolpidem and zaleplon, henceforth referred to as sedatives) continue to be~     prescribed inappropriately to patients in hospital and community settings.~      Our primary objective is to facilitate the deprescription of benzodiazepine and~     non-benzodiazepine sedative hypnotics (sedatives) using a combination of physician education~     sessions and an updated patient educational pamphlet based on Tannenbaum's EMPOWER study~     conducted in a community-based setting.~   "
56109|NCT02832557|"~     The goal of this study is to identify miRNAs that are at increased or decreased levels in the~     saliva of children with autism spectrum disorder (ASD) or developmental delay and would be~     useful biomarkers for the screening of toddlers and young children for ASD. These biomarkers~     may allow earlier diagnosis of autism, allowing earlier service, and also help us to~     understand some of the changes in the brains of autistic children.~   "
56056|NCT02833259|"~     From 10% to 30% of patients hospitalized with community-acquired pneumonia (CAP) are~     readmitted within 30 days of discharge. These readmissions have negative consequences for the~     patients and the hospitals where they are treated, including impaired quality of life,~     exposure to hospital-related adverse events, and increased resource utilization.~      Risk-adjusted readmission rates can be easily computed and tracked from computerized hospital~     discharge data, using validated models. As part of the Hospital Readmission Reduction Program~     (HRRP) effective in fiscal year 2013, United States hospitals with higher than expected~     30-day readmission rates after pneumonia hospitalization have been subject to financial~     penalties from the Center for Medicare and Medicaid Services (CMS). The underlying logic of~     the HRRP is based upon the notion that short-term readmission is often a preventable adverse~     outcome, reflecting suboptimal quality of care during index hospitalization. Yet, published~     evidence suggests that less than one in four all-cause readmissions are deemed avoidable.~     Because only avoidable readmissions can be influenced by interventions designed to decrease~     readmission rates, avoidable readmission is a more relevant metric than all-cause readmission~     for tracking quality of hospital care for pneumonia.~      The purpose of this study is to develop an administrative data-based risk prediction model~     for identifying potentially avoidable readmissions within 30 days of discharge for patients~     hospitalized with CAP.~      R3P is a retrospective observational cohort study of consecutive adult patients discharged~     from two hospitals with a diagnosis code of CAP. Data sources include routinely collected~     hospital discharge data and retrospective chart reviews.~   "
56057|NCT02833246|"~     This study is being done to determine if sending reminder text messages helps patients take~     their Oral Anticancer Medication (OAMs) when they are supposed to.~   "
56058|NCT02833233|"~     This study is being done to evaluate the safety of combining two strategies called~     cryoablation and immune therapy in women with curable early stage breast cancer.~   "
56059|NCT02833220|"~     The purpose of this study is to determine the effects of TMS on the ANS. The investigator~     will determine whether single-pulse TMS of the primary motor cortex in the dominant~     hemisphere in healthy, young adults will affect 1) heart rate and heart rate variability, 2)~     blood pressure and 3) baroreflex function. This study is foundational in that it will begin~     to characterize how single-pulse TMS affects the ANS in healthy adults.~   "
56060|NCT02833207|"~     The growing population of obese adults is predicted to create a large public health burden in~     the next few decades. This study examines function of small blood vessels providing blood~     flow to skeletal muscles, to test if younger obese individuals (≤40 years old, BMI >30) are~     already displaying reductions in blood vessel function. This study will test if the signals~     blood vessels use to increase blood flow are changing in these same subjects. Findings from~     this study may help create treatments to delay or prevent some of the negative effects of~     obesity on vascular health.~   "
56061|NCT02833194|"~     The primary objective of this study was to evaluate and compare the prevalence of the~     following psychiatric pathologies (based on the MINI5.0.0 questionnaire) among 3 groups of~     women (Leiden versus aP1Ab-positive versus thrombophilia-negative) with similar obstetrical~     histories 10 years after their initial assessment/diagnosis.~        -  Mood disorders, including depressive episodes during the previous two weeks, recurrent~          depressive disorders at any point in life, dysthymia in the last two years, or any~          current or past manic episode;~        -  Anxiety disorders, including current agoraphobia, current panic disorders, agoraphobia~          with panic disorders, current social phobia, generalized anxiety in the last 6 months,~          or current posttraumatic stress syndrome;~        -  Apparent psychotic syndromes, including isolated or recurrent psychotic syndromes, past~          or present (clinically validated),~        -  Current alcohol or drug problems (dependence or abuse).~   "
56062|NCT02833181|"~     The investigators propose to evaluate circadian variation of EEG using BIS (bispectral index)~     monitor in ICU patients in three different groups: non-sedated, only sedated and sedated and~     curarized. BIS monitor values as SR (suppression rate), SEF (Spectral edge frequency),~     bispectral index and EMG (electromyography) during 24 hours in admitted patients except acute~     neurological disease.~   "
56063|NCT02833168|"~     It is the aim of this project to develop and validate a German language screening~     questionnaire for symptoms of respiratory muscle weakness and sleep-disordered breathing~     (SDB) in patients with neuromuscular disorders.~   "
56064|NCT02833155|"~     The purpose of this study is to evaluate the safety and tolerance of entinostat administered~     orally as a single agent in a weekly dosing schedule. Additionally, this study will~     characterize the pharmacokinetics parameters in Chinese postmenopausal women with advanced~     breast cancer. And to define the profile of adverse events, including laboratory parameters~     in these subjects~   "
56065|NCT02833142|"~     The primary objective of the study is to characterize the pharmacokinetics (PK) of BIIB033-B~     and to compare the PK profile with that of BIIB033-A in healthy volunteers. Secondary~     objectives are: To assess the safety and tolerability of BIIB033-A and BIIB033-B; To assess~     the secondary PK parameters of BIIB033-A and BIIB033-B; To assess the immunogenicity of~     BIIB033-A and BIIB033-B.~   "
56066|NCT02833129|"~     The purpose of this study is to assess the effect of playing high school football on later in~     life cognitive functioning and mental health. This is an observational study that will use~     data from the Wisconsin Longitudinal Study to compare high school football playing graduates~     in 1957 with comparable non-high school football playing graduates on cognitive functioning~     and mental health measures when participants are in their 60s.~   "
56067|NCT02833116|"~     This study evaluate the administration of epidural betamethasone versus dexamethasone for~     pain reduction, consumption of analgesic and quality of life. Half of the patient will~     receive dexametasone and the other half betametasone.~   "
56068|NCT02833103|"~     Sphincter of Oddi dysfunction (SOD) refers to biliary kinetic abnormality of the sphincter of~     Oddi (SO), often accompanied by pain, hepatic and pancreatic enzyme elevation, common bile~     duct (CBD) dilation or onset of pancreatitis. Pain caused by SOD affects the quality of life~     (QoL).The primary objective of this trial is to evaluate the efficacy of relieving abdominal~     pain of Pinaverium Bromide in medication therapy for patients with post-cholecystectomy SOD.~   "
56069|NCT02833090|"~     The goal of this study is to describe the increase in plasma serotonin or 5-hydroxytryptamine~     (5-HT) in patient with increased severity of aortic stenosis and increased weight cardiac~     muscle.~   "
56070|NCT02833064|"~     Acute liver injury (ALI) and acute liver failure (ALF) are rare clinical conditions, the~     latter often associated with a poor outcome. To improve outcomes for these patients,~     clinicians need to develop a clearer understanding of the pathophysiology of this condition.~     Biomarkers and novel imaging techniques are vital to investigating and understanding the~     pathophysiology of ALI. Patients with ALI or ALF aged over 16 and due to any cause will be~     eligible to take part in the study. The study will involve collection of biological samples~     (blood, urine, stool and breath) from included patients once daily for up to 7 days. For~     patients undergoing liver transplantation, a small sample of explanted (removed) liver tissue~     will be obtained. A small subgroup of patients with paracetamol induced acute liver failure~     will be eligible to be included in a pilot MRI (magnetic resonance imaging) study, which will~     involve two MRI scans during the first 7 days of their admission. All patients will be~     recruited from the Royal Infirmary of Edinburgh.~   "
56071|NCT02833051|"~     The purpose of this project is to examine the effects of an acute bout of exercise on~     children's energy intake over the course of a day. Previous studies in adolescents and adults~     have shown exercise to be effective in decreasing short-term energy intake, with some~     variability. Individual characteristics such as habitual physical activity and psychological~     factors may influence the effect of exercise on energy intake, but these factors have yet to~     be examined. The investigators have assembled a multi-disciplinary team of researchers, with~     expertise in eating behavior, exercise, psychology, and clinical research in order to examine~     these questions. First, the investigators will examine the difference in energy intake at~     lunch, snack, and dinner meals in response to 30 minutes of imposed exercise compared to 30~     minutes of rest. Second, the investigators will collect objective measures of children's~     habitual physical activity, child characteristics (body composition, eating behavior traits),~     and individual responses to the controlled exercise bout. The investigators can then examine~     both group and individual differences in the energy intake response to exercise. Twenty~     children (ages 9-12) will be tested over the course of three visits. The key outcome will be~     differences in energy intake in response to exercise vs. rest. Secondary outcomes include the~     influence of differences in habitual physical activity, personal characteristics, and~     responses to the exercise bout on children's energy intake. The long term goal of this line~     of research is to understand the mechanisms behind the interaction between exercise and~     energy intake. The translational potential of this research will be to inform personalized~     childhood obesity prevention strategies in children at risk for overweight.~   "
56072|NCT02833038|"~     The primary purpose of this study is to investigate the effect of intravenous magnesium on~     blood pressure after Trendelenburg position during robot assisted prostatectomy.~      The secondary purpose of this study is to investigate the effect of intravenous magnesium on~     pain after robot assisted prostatectomy.~   "
56073|NCT02833025|"~     Coagulopathy after cardiopulmonary bypass (CPB) is associated with increased morbidity and~     mortality. Clot formation and clot stability are important factors in coagulation and~     hemostasis. As such platelet dysfunction and impaired thrombin generation play a central role~     in bleeding after cardiac surgery. The primary objective of this study is to evaluate the~     relationship between point-of-care determined platelet function and thrombin generation and~     postoperative bleeding in infants and young children undergoing cardiac surgery with~     cardiopulmonary bypass adjusting for clinically important confounding factors.~   "
56074|NCT02833012|"~     To compare serum ketone body (i.e., total ketones, β hydroxybutyrate, and estimate of~     acetoacetate) levels after single dose administration of caprylic triglyceride (CT) oil,~     AC-1202, AC-1204, and Axona®.~   "
56075|NCT02832999|"~     This is a single blind randomised controlled clinical trial in uncontrolled type 2 Diabetes~     mellitus patients on oral glucose lowering agents, and naive to incretinomimetic.~     Participants will be randomised in two Arms : arm 1 receiving Liraglutide at 1,2 mg/day and~     arm 2 Vildagliptine at 100mg/day over 14 days. The two arms will be compared for 14-day~     changes in insulin secretion and insulin sensitivity.~   "
56076|NCT02832986|"~     Herpes zoster and post herpetic pain are common causes of morbidity in the elderly. Herpes~     zoster is caused by reactivation of the virus varicella zoster of latent infection in sensory~     ganglia. The acute phase of herpes zoster usually occurs ≤ 30 days after rash onset. However,~     the most common complication of herpes zoster is the post herpetic pain, which is usually~     defined as a persistent chronic pain for ≥ 3 months after rash onset. The risk of herpes~     zoster in life is 25-30%, but this figure rises to 50% among those aged ≥ 85 years.~     Similarly, the risk of experiencing post herpetic pain increases with age.~      Despite treatment with antiviral drugs, post herpetic pain has been reported in 10-20% of all~     patients with herpes zoster, but its incidence increases significantly in elderly patients~     over 60 years. It can be particularly harmful when it occurs on a particular field, elderly~     multiple pathologies, fragile and with multiple treatment. In this context of decompensation~     cascade greatly exacerbate the impact of the initial local disease. Ophthalmologic~     involvement is rare but clinically worrisome and generates significant costs.~   "
56077|NCT02832973|"~     A randomized clinical trial comparing sequential nephron blockage (SNB) with dual blockade of~     the renin-angiotensin system (RAAS) plus bisoprolol (DBB) in the treatment of resistant~     arterial hypertension (RH) was designed to investigate the importance of the SNB and the~     contribution of its volume component versus DBB and the importance of the serum renin in~     maintaining BP levels. This randomized trial with two treatment arms could help tailor~     therapy by identifying a more effective choice to control hypertension whether by acting on~     the control of volume or sodium balance, or by acting on the effects of the RAAS on the~     kidney.~      Methods - Participants: 80 patients undergoing treatment for RH with losartan (100-200 mg),~     chlorthalidone (25 mg), and amlodipine (5 mg) will be randomly divided into two groups after~     applying inclusion and exclusion criteria.~      Group 1: Sequential nephron blockade (SNB Group) n = 40 Group 2: Dual blockade of the RAAS~     plus bisoprolol (DBB Group) n = 40 Intervention: SNB consists in a progressive increase in~     sodium depletion. After the administration of a thiazide diuretic (chlorthalidone) and~     aldosterone receptor blocker, low doses of furosemide are administered and subsequently~     amiloride is prescribed to enhance the natriuretic effect.~      The dual blockade of the RAAS plus bisoprolol is used to increase the effect of angiotensin~     receptor 1 blockers (ARBs). Therapy then requires sequentially adding an angiotensin~     converting enzyme (ACE) inhibitor to reduce the levels of angiotensin (Ang) II resulting from~     blockage of the Ang II receptor and then to administer a beta-blocker to decrease the~     elevated renin secretion due to both the ACE inhibitors and ARBs Objective: This study, which~     compares two antihypertensive treatment regimens in patients with RH, has the following~     objectives: to demonstrate the therapeutic efficacy of SNB against DBB in RH patients, and to~     assess the side effects and adherence to treatment over 20 weeks of treatment.~      Enrollment: The eligibility criteria will follow those shown in the flowchart for the~     diagnosis of RH of the First Brazilian Position on RH.~      Patients will be excluded if they have: chronic renal failure, atrial~     fibrillation/atrioventricular block, contraindication to the drugs that will be used, refusal~     or failure to follow the regimen and secondary hypertension.~      Follow-up: Patients will be analyzed in five visits at intervals of 28 days for 20 weeks~   "
56078|NCT02832960|"~     Coronary heart disease (CHD) and heart failure (HF) are the leading causes of mortality and~     morbidity, particularly with the current context of an aging population. Prospective cohort~     studies, as well as analyses of pooled individual participant data suggest up to a 60-90%~     increase in the risk of CHD or HF events among adults with severe SHypo. However, no large~     randomized controlled trials (RCT) have assessed the impact of thyroid replacement on~     cardiovascular (CV) imaging outcomes. The goals of this proposal are to address the impact of~     thyroid replacement on cardiac function. The investigators will conduct a RCT in 185 patients~     with subclinical hypothyroidism who will be randomly assigned to thyroxine or placebo with an~     average follow-up of 24 months from baseline. The main outcome will be CV imaging modalities~     measured by echocardiography at the close-out visit. Assessment of the impact of thyroid~     replacement on cardiac function and subclinical atherosclerosis within a trial will aid~     decisions and evidence-based guidelines development to treat a potential modifiable risk~     factor, such as SHypo.~   "
56079|NCT02832947|"~     Aim of this clinical Trial is the assessment of rivaroxaban PK/PD parameters in patients 6-8~     months after bariatric surgery~   "
56080|NCT02832934|"~     Coronary heart disease (CHD) are the leading causes of mortality and morbidity, particularly~     with the current context of an aging population. Prospective cohort studies, as well as~     analyses of pooled individual participant data suggest up to a 60-90% increase in the risk of~     CHD or HF events among adults with severe SHypo. However, no large randomized controlled~     trials (RCT) have assessed the impact of thyroid replacement on cardiovascular (CV) imaging~     outcomes. The goals of this proposal are to address the impact of thyroid replacement on~     subclinical atherosclerosis. The investigators will conduct a RCT in 185 patients with~     subclinical hypothyroidism who will be randomly assigned to thyroxine or placebo with an~     average follow-up of 24 months from baseline. The main outcome will be CV imaging modalities~     measured by carotid ultrasound at the close-out visit. Assessment of the impact of thyroid~     replacement on subclinical atherosclerosis within a trial will aid decisions and~     evidence-based guidelines development to treat a potential modifiable risk factor, such as~     SHypo.~   "
56081|NCT02832921|"~     The primary objective of this program is to apply a virtual reality (VR) cognitive-motor~     intervention (compared to active and passive control groups) to delay or slow cognitive~     decline of middle-aged adults who have a family history of Alzheimer's disease (AD) and thus~     are at particularly high risk of developing the disease.~   "
56082|NCT02832908|"~     Brain trauma is an important burden in traumatologic intensive care. In these patients the~     treatment is guided by a cluster of multimodal monitoring parameters. Despite this it is~     difficult to assess the actual physiopathologic status of the brain. Changing the position of~     these patients (semi-seated to lying position) causes changes in the hémodynamics brain~     conditions, so in monitoring parameters . The analysis of these changes can givr us valuable~     clinically informations.~   "
56083|NCT02832895|"~     Transcranial doppler (TCD) is an established tool for monitoring flows in intracranial~     cerebral arteries. Its use is recommanded in the last guidelines on traumatic brain injury.~     The temporal bone window (TBW) is limited in evaluating flow in the anterior cerebral~     arteries (ACA) because of an unfavorable insonation angle. Thereby TCD could be unfit to~     detect a segmental lesion on the anterior cerebral arteries (ACA).~      The frontal bone window (FBW) is a promising approach in evaluating flows in the ACA.~     However, the utility of the FBW for patients with acute brain injury (ABI) in ICU has not~     been yet determined.~      The goal of the present study is to determine the rate of detection of the ACA by using the~     FBW in patients with ABI in ICU.~   "
56084|NCT02832882|"~     In this study, the investigators are going to prospectively compare the clinical outcomes~     (technical success rate, 12 month local tumor progression rate, complication rate, tumor~     seeding rate) of Radiofrequency ablation (RFA) with octopus electrode and no-touch technique~     for Hepatocellular carcinoma (HCC) to those of RFA with conventional tumor puncture method~     with the same device.~   "
56085|NCT02832869|"~     High quality bowel preparation is essential for successful colonoscopy. This study aimed to~     assess the impact of reinforced education by Wechat or short message service (SMS) on the~     quality of bowel preparation. This prospective, endoscopist-blinded, randomized, controlled~     study was conducted. Reinforced education groups received additional education via reminders~     by Wechat or SMS 2 days before colonoscopy. The primary outcome was the quality of the bowel~     preparation according to the Boston Bowel Preparation Scale (BBPS). The secondary outcomes~     included polyp detection rate (PDR), adenoma detection rate (ADR), tolerance, and subjective~     feelings of patients.~   "
56086|NCT02832856|"~     This evaluation will test the program effectiveness of a relationship education program~     (Relationship Smarts PLUS)and an abridged version of the program to 9th Grade Students on~     outcomes of knowledge. It will test 1) whether the Relationship Smarts (RS) Curriculum is~     more effective than a control curriculum of job-readiness programming, and 2) whether an~     abridged 8-lesson version of the RS Curriculum can be as effective as the full 12-lesson~     version.~   "
56087|NCT02832843|"~     The aim of this study was to elucidate genetic susceptibility of patients with nontuberculous~     mycobacterial lung disease using genome-wide association study.~   "
56088|NCT02832830|"~     The aim of this explorative trial is to verify the comparability of a fractionated intensity~     modulated radiotherapy with a conventional radiotherapy related to quality of life on the one~     hand and to evaluate toxicity, re-calcification and stability of vertebral body as well as~     pain relief and local response for palliative patients with painful spinal bone metastases on~     the other hand. This is a single-center, prospective randomized controlled trial with~     parallel-group design to determine the quality of life after RT in patients with spinal bone~     metastases. Two different techniques were evaluated: intensity modulated radiotherapy (IMRT)~     and fractionated conventional external beam RT with 10×3 Gy each.~      Experimental intervention:~      IMRT 10 x 3 Gy~      Control intervention:~      3D-RT 10 x 3 Gy~   "
56110|NCT02832544|"~     This program is a comprehensive evaluation of rheumatic valvular heart disease (RVHD), Atrial~     fibrillation (AF)/flutter and stroke.~      A prospective, randomized, parallel group, open-label clinical trial of rivaroxaban versus~     standard vitamin K antagonists (VKA) therapy to evaluate non-inferiority of rivaroxaban to~     VKA, with testing for superiority if non-inferiority is satisfied.~   "
86150|NCT02439411|"~     The purpose of this study is to analyze whether Dabrafenib +/- Trametinib are effective in~     overall survival, response rates and toxicity in both programs.~   "
56089|NCT02832817|"~     Hypoxemia is a frequent situation in clinical practice, particularly in intensive care units~     or perioperative. The mortality and morbidity increase for cardiovascular reason, due to~     hypoxia has been reported several times. It is therefore important to detect hypoxemia very~     early and with accuracy. The objective is to correct the causes quickly and thus avoid or~     minimize complications.~      In addition to the risks associated with hypoxemia, the monitoring of Arterial Oxygen~     Saturation also avoids the adverse effects associated with hyperoxia. Indeed oxygen leads to~     the formation of free radicals, which in physiological condition are regulated by antioxidant~     mechanisms. However, in anesthesiology, it is common to find pathological situations (acute~     respiratory distress syndrome, shock, prolonged inflammatory state) where these regulatory~     mechanisms are overwhelmed. Oxygen administration to supra-physiological concentrations leads~     to a formation of excessive free radicals, aggravating the existing injury (including lung).~      Oxygen therapy is a fully-fledged treatment requiring monitoring of its effectiveness and~     tolerance. Currently, the standard method for assessing oxygenation is the arterial blood gas~     analysis with the Arterial Oxygen Saturation. Its cost and the need for an arterial blood~     sample do not allow regular monitoring. Clinical evaluation of hypoxia is completely~     unreliable. there is a third method : monitoring devices that measure Arterial Pulsed Oxygen~     Saturation, called pulse oximeters. Pulse oximeters have become an integral and mandatory~     part of the standard monitoring. It is through the measurement of Arterial Pulsed Oxygen~     Saturation, supposed to reflect Arterial Oxygen Saturation, that clinicians guide their~     therapeutic attitudes to optimize oxygenation and improve the prognosis of patients. So pulse~     oximetry is a method considered reliable and especially non-invasive. It is less expensive~     and does not require blood sampling. These qualities explain why these devices are easily~     used in anesthesia, intensive care and in emergency situations.~      However, several studies have demonstrated the inaccuracy of Arterial Pulsed Oxygen~     Saturation in frequent situations resuscitation (shock, sepsis, dark skin type). Thus, it is~     necessary to objectify the benefits and limitations of pulse oximetry to optimize their use,~     especially in these situations of high risk, where a discrepancy between the values measured~     by the pulse oximetry and measurement of arterial blood saturation with oxygen gas can be~     detrimental.~      It exists several pulse oximetry devices, whose accuracy seems unequal, which necessitates a~     comparative study.~   "
56090|NCT02832804|"~     To evaluate the clinical efficacy and safety of neuromodulation by transcranial direct~     current stimulation (tDCS) in the patients with primary chronic insomnia .~   "
56091|NCT02832791|"~     The purpose of this randomized study is to compare clinical and functional outcomes of both~     surgery techniques for anterior cruciate ligament reconstruction (using quadriceps tendon~     versus hamstring tendon) after reconstruction in athletes.~   "
56092|NCT02832778|"~     The purpose of the study is to measure the drug levels in the blood of HIV-infected~     individuals taking anti- HIV medication efavirenz 400 mg once daily in the presence of~     anti-TB medication rifampicin and isoniazid. The study is being run in two-stages - London~     (Stage 1) and Kampala (Stage 2).~      In London (Stage 1): HIV-1 infected patients (without tuberculosis infection) on established~     treatment with a combination based on 600 mg efavirenz dose will be recruited.~      In Kampala (Stage 2): Patients with both HIV-1 and tuberculosis infection being treated with~     600 mg efavirenz combination for HIV AND undergoing TB treatment with a dual therapy regimen~     contaning rifampicin and isoniazid will be recruited.~      Efavirenz-containing regimens are recommended as first-line therapy for HIV-TB co-infected~     patients. It has been shown there is a lack of a significant difference between efavirenz 400~     mg and efavirenz 600 mg, indicating that 400 mg efavirenz is non-inferior to the standard~     dose.~      The advantages of antiretroviral dose reductions may translate into greater benefits for more~     individuals infected by HIV globally, since they may allow access programs to reach higher~     numbers of infected patients and compensate for the finite global manufacturing capacity and~     increasing demand. For efavirenz, significant price reductions have been achieved through~     elimination of trade, logistics and manufacturing capacity barriers, and further price~     reductions could be achieved with a significant reduction in the cost of pharmaceutical~     ingredients. However, no data on the PK and effectiveness of efavirenz 400 mg once daily~     during TB treatment has been produced. Given that many patients on Efavirenz- based ART will~     need to be treated for TB during their lifetime and rifampicin is one of the most commonly~     used treatment for tuberculosis, it is important to study the reduced dose under carefully~     monitored conditions prior to roll out of a lower dose standard treatment. Therefore, we aim~     to investigate the PK of efavirenz 400 mg once daily in HIV-infected individuals in the~     presence of rifampicin and isoniazid in London, UK and in HIV/TB-co-infected individuals on~     dual anti-TB treatment in Kampala, Uganda~   "
56093|NCT02832765|"~     The primary goal of the study is to determine the local control-rate after radiotherapy (RT)~     with and without simultaneous integrated boost (SIB) concepts in patients with bone~     metastases of the spine. Further study objectives are survival, and clinical parameters such~     as pain, quality of life (QoL) and fatigue. We expect an improvement in local control and~     consecutively an increased re-sclerotization of the bone metastasis due to a higher~     biological dose in the tumor area. Therefore patients could benefit in quality-of-life, pain~     relief and mobility.~   "
56094|NCT02832752|"~     The addition of an Extracorporeal-Cardiopulmonary Resuscitation (ECPR) service to a region~     may improve the survival of young patients with sudden unexpected cardiac arrest.The primary~     aim of this study is to determine the benefit of the systematic integration of ECPR services~     into the out-of-hospital cardiac arrest management algorithm. This study is a controlled~     parallel group design with group allocation based on region of treatment. The investigators~     will compare the outcomes of ECPR-eligible patients in the intervention region, in comparison~     to patients meeting the same criteria in a comparable setting.~   "
56095|NCT02832739|"~     The aim of the USECARE project is to improve and test SENACA, an ICT-based self-management~     support system for chronically ill patients and informal caregivers. 60 end-users will be~     instructed to use SENACA for approx. 3 months (in Israel and Norway). Amongst others,~     clinical and behavioural outcomes will be recorded. Additionally, SENACA's usability will be~     evaluated to determine its potential future scalability.~   "
56096|NCT02832726|"~     The study investigates the absorption of different doses of hydroxocobalamin and~     cyanocobalamin in a vitamin B12-replete Danish population.~   "
56097|NCT02832713|"~     In France, osteoarthritis affects about 10 million people and knee osteoarthritis represents~     35% of cases. It is thought that more than 2.5 million people older than 65 years have knee~     osteoarthritis.~      Currently, osteoarthritis management is based on three major axes:~        1. Non-pharmacological means, such as patient education, loss of weight and physical~          activity~        2. General pharmacological treatments: mainly paracetamol and then schedule II and III~          painkillers as well as nonsteroidal anti-inflammatory agent.~        3. Intra-articular pharmacological treatments:~             1. Intra-articular injections of corticosteroids: they are recommended during~               hydarthrotic flare-ups~             2. Intra-articular injections of hyaluronic acid (HA) (viscosupplementation) in the~               absence of intra-articular effusion. However, their efficacy is questioned by most~               experts in the case of symptomatic knee osteoarthrosis.~        4. Sometimes, surgery is the only therapeutic option. However, besides the fact of exposing~          patients, who are sometimes frail, to several peri- and post-operative complications,~          the recovery rate (variable according to the prosthesis type and ranging from 5% to 25%~          at 9 years) in an ageing population justifies waiting as much as possible before~          surgery. Therefore, it is important to test new therapeutic options for symptomatic~          osteoarthrosis that will allow postponing the surgical treatment.~        5. The use of botulinum toxin (BoNT-A) could thus represents an interesting alternative.~          BoNT-A is habitually used by intra-muscular injection for its myorelaxant effect in the~          management of painful reactive periarticular muscle contractures. However, BoNT-A has~          also antalgic activity independently of the myorelaxant effect. This allows explaining~          in part the antalgic effect of intra-articular BoNT-A injection. In the literature, six~          randomized controlled studies (RCS) have compared BoNT-A and intra-articular injections~          of corticosteroids, hyaluronic acid, or placebo. Only two RCS concerned knee~          osteoarthritis and compared BoNT-A to corticosteroids and a placebo, respectively, with~          a significant antalgic effect only in the groups treated with BoNT-A. No study has~          compared yet the intra-articular injection of BoNT-A to the viscosupplementation by HA~          in knee osteoarthritis and this is the aim of this trial.~   "
56111|NCT02832531|"~     This program is a comprehensive evaluation of rheumatic valvular heart disease (RVHD), Atrial~     fibrillation (AF)/flutter and stroke.~      A prospective, randomized, open-label superiority trial comparing rivaroxaban to aspirin in~     high risk patients either with AF and unsuitable for VKA or without AF and with high risk~     factors.~   "
90968|NCT02376465|"~     To evaluate the safety, tolerance and efficacy of BLI4600 in multiple dosing regimens as a~     bowel preparation prior to colonoscopy in adult patients.~   "
56098|NCT02832700|"~     Casein glycomacropeptide (CGMP) has anti-inflammatory properties in experimental rodent~     colitis and using human in vitro inflammation models. Its use as a food ingredient has proven~     safe and with no influence on dietary intake. In a pilot study the investigators found, that~     orally administered CGMP seems to have a beneficial effect comparable to that of mesalazine~     in active distal ulcerative colitis.~      The investigators now wish to evaluate the effects in healthy subjects by studying the~     anti-inflammatory and microbiome modulating properties and by assessing possible changes in~     gastrointestinal symptoms.~   "
56099|NCT02832687|"~     Study Objective The aim of the proposed study is to examine the effect of Q4 hour multidose~     IV acetaminophen on patients' readiness for discharge. In doing so the investigators will~     also investigate the various factors that could potentially contribute to a patient's~     readiness for discharge such as overall opioid consumption, time to rescue medication,~     incidence of postoperative nausea and vomiting, pain scores, and perioperative stress markers~     and their overall correlation with IV acetaminophen intake.~   "
56100|NCT02832674|"~     A prospective evaluation of the ThermiRF device in treating skin laxity under the chin and~     neck. Seventy male and female subjects between the age of 35 and 65 (inclusive) will be~     enrolled in this trial. The first 30 subjects will have a total of 6 study visits while the~     remainder will have a total of 5 study visits.~      All subjects will have a single treatment administered. The first 30 subjects will have an~     extra visit at Day 60 intended to allow collection of photo images post treatment to be used~     for the validation of three blinded raters.~      Photo images will be collected using 2D standard photography and 3D using the Vectra system.~     The architecture of the skin in the affected area will be measured using the Cutometer, a~     suction like instrument that measures elasticity. Sensory and safety will be measured using a~     0-10 point numerical rating scale (NRS) and collection of safety reports. The study duration~     is approximately 6 months.~   "
56101|NCT02832661|"~     Biomargin is a European research program aimed at evaluating the diagnostic performance of~     biomarkers with respect to renal graft injuries, as well as their prognostic performance with~     respect to 3-year and 5-year graft outcomes.~      Nucleic acids, proteins and metabolites previously identified as candidate biomarkers of~     individual kidney graft lesions will be determined systematically in urine and blood samples~     collected in patients from the time of transplantation onwards, as well as in the graft~     tissue when biopsies are required for medical causes or performed systematically in the~     investigation centres. Their diagnostic and prognostic performance will be checked against~     histological reading of the biopsies and evolution of the graft function over time.~   "
56102|NCT02832648|"~     This research aims to determine whether selenium supplements improve bone and muscle health~     in older women at risk of osteoporosis (low bone density or weak bones) and fracture (broken~     bones).~      Osteoporosis is a major public health problem. One in two women and one in five men over age~     50 will have a fracture. Fractures cause pain, disability and reduce life-expectancy. Women~     with below-average bone density around the time of the menopause might have previously taken~     hormone replacement (HRT) to prevent osteoporosis, but HRT is much less used now due to side~     effects. Therefore there is a need for safe, effective and inexpensive preventative~     interventions for women at risk of osteoporosis.~      Selenium is a chemical nutrient present in several human proteins, including anti-oxidants.~     Anti-oxidants may protect against ageing of tissues, including bone, by mopping up damaging~     reactive oxygen molecules (sometimes called 'free radicals'). Selenium is present in soil,~     and so is obtained from many foods. However, soil selenium levels are low in Europe, and~     dietary intake in the UK is below recommended levels.~      We previously found that women with higher blood selenium levels have stronger bones, but~     this doesn't prove that giving selenium will improve bone strength.~      The investigators propose a randomised controlled trial to compare selenium supplements with~     a placebo (dummy treatment) in women with below-average bone density. The investigators will~     give selenium (at two different doses) or placebo to 120 women for six months and use blood~     and urine tests and bone density scans to see if giving selenium does have any effect on~     bone. The investigators will also do muscle function tests and measurements of free radical~     molecules.~   "
56103|NCT02832635|"~     The purpose of this study is to evaluate the effects on neurocognitive function of~     whole-brain radiotherapy (WBRT) with/without TMZ concurrent chemotherapy or avoidance of~     hippocampus for patients of brain metastases, as well as the feasibility and risk of~     avoidance of hippocampus during whole-brain radiotherapy.~   "
56104|NCT02832622|"~     This is a prospective, multicenter, non-randomized registry/observational study. The study~     will enroll up to 2,000 patients with successful St. Jude Medical (SJM) Cardiac~     Resynchronization Therapy (CRT) MP device implant from up to 140 centers undergoing CRT~     implantation.~   "
56105|NCT02832609|"~     The purpose of this study is to study the role of closing volume as a determinant of~     orthopnea in stable obese subjects. The investigators hypothesized that: (1) increase in~     closing volume in supine position would be greater in orthopneic than in non-orthopneic~     subjects, and (2) the relationship of change in closing volume to change in dyspnea with~     position would be dependent on expiratory flow limitation in the sitting position.~      In stable obese subjects, in sitting and supine positions, the investigators measured Borg~     dyspnea score, static lung volumes, expiratory flow limitation, and single-breath nitrogen~     expiration test, from which the investigators determined closing volume and closing capacity,~     slope of phase III, and opening capacity.~      Orthopnea was defined as any increase in the Borg score in the supine position from its value~     in the sitting position~   "
56106|NCT02832596|"~     The arterial blood pressure is thought to affect the ratio between filtration and~     reabsorption of fluids in the circulating blood volume and thereby the plasma volume. During~     induction of anesthesia blood pressure, hemoglobin level and hematocrits decreases and the~     plasma volume increases. The aim of the study is to evaluate weather a maintained blood~     pressure with norepinephrine during anesthesia induction reduces the increase in 125~     iodine-labeled human serum albumine (125I-HSA) measured plasma volume.~   "
56107|NCT02832583|"~     The aim of this prospective study is to assess the efficacy of autologous Platelet Rich~     Plasma combined with Hyaluronic Acid prepared with RegenKit-BCT HA Cellular Matrix on skin~     rejuvenation. Thirty-one patients were included and received three PRP-AH injection sessions~     4 weeks apart into the cheeks. The outcomes were assessed at baseline, 1, 3 and 6 months~     after the last injection session. Safety was assessed by reported adverse event analysis.~   "
56112|NCT02832518|"~     The incidence and prevalence of dialysis in Taiwan remains higher as compared to past several~     years. The number of dialysis reported about 6-7 million people each year and the 2014~     full-year cost estimation was about 330 million NTDs. According to age-standardized~     population statistics in 1995, the number of dialysis per million population in 2006 year~     were 372.2 people, 381.9 people in 2012 year and the annual growth rate of 0.43 percent~     recorded.~      EarlySense system is certified by TFDA, FDA and many other countries, which consists of~     mainly two parts. One for the sensing element, which placed under the mattress and the other~     one is AC-powered display panel bed. This system has the ability to monitor the patients~     physiological functions just be in contact via bed. When the patient laid on bed, the sensor~     which is placed under the bed would detects heart rate, breathing rate and activity level as~     well as other physiological signals. The system is also able to distinguish between patients~     in bed and out of bed during the operation to save the patient's records and information~     (including heart rate, respiratory rate and level of activity, and may render trends). The~     system is also have capability for real-time data transmission information which includes a~     warning to the nurses' station or other monitoring center of the screen by providing~     real-time information to nurse.~      In this research project, we will use EarlySense equipment for continuous monitoring the~     dialysis patient's physiological data along with clinical data such as A. acute complications~     such as rapid changes in blood pressure, respiratory rate, movements of patients and Nausea~     or vomiting, etc phenomenon's) B. Lab examination data C. Status of patient whether patients~     hospitalized or not and patient death occurred or not. The study is expected to have a pilot~     study for more than three months' duration. Through this EarlySense continuous monitoring and~     gather the data, we will analyse to develop a prediction model and confirmed with indicators.~     Evidences from these analytics would help to propose ways to improve it and implement~     Positive predictive validity models.~   "
56113|NCT02832505|"~     This study has two major purposes:~        1. To test developed multiple anatomic and functional MRI methods;~        2. To evaluate the potentials of these MRI methods in the diagnosis, prognosis, and~          monitoring of the progression of renal dysfunction.~      These purposes will be achieved by performing pilot studies with cohorts of patients.~   "
56114|NCT02832492|"~     Previous studies suggest that the stimulus of pupil near response (PNR) may be a conscious~     perception of a blurred image. Moreover, PNR is a reflex that can be objectively observed and~     with no motor output, suggesting it might be a more convenient index for consciousness~     evaluation and consciousness recovery in patients with disorders of consciousness (DOC). We~     thus hypothesized that PNR+ patients (patients show PNR during the assessment) would have~     better prognosis than PNR- patients (patients fail to show PNR during the assessment).Based~     on this hypotheis, researchers will assess pupil near response in patients with unresponsive~     wakefulness syndrome (UWS) and compare the prognosis difference between PNR+ patients and~     PNR- patients to assess its prognosis value.~   "
56115|NCT02832479|"~     Evolution of medical care for patients with cystic fibrosis appeared in recent years:~     prolongation of life expectancy with consequently increased comorbidities and the use of lung~     transplantation, systematic neonatal screening of new born since 2002, prescription of~     expensive new molecules or new presentation. This evolution justifies to realize an update of~     statistics of costs of care and to assess adherence to treatment~   "
56116|NCT02832466|"~     Patients undergoing haemodialysis present a decrease in physical function, but little is~     known about the rate at which function decreases.~      The purpose of this study is quantifying the nature and degree of functional deterioration~     experienced by stage 5 chronic kidney disease patients during a six month period of~     maintenance haemodialysis therapy.~   "
56117|NCT02832453|"~     The purpose of this study is evaluate the effectiveness of different doses of supervised~     exercise training intensity -concomitant to lifestyle counselling- as a Primary Health Care~     intervention tool for the management of the metabolic syndrome in low active adults with one~     or more metabolic risk factors.~      Secondary aims of the study are to investigate the effects of these interventions on systemic~     inflammation and adipose tissue function, cardiorespiratory fitness, physical activity and~     sedentary habits, and the cost-effectiveness of the intervention with regard to health~     related quality of life.~      The general hypothesis is that adults with risk factors for metabolic syndrome participating~     in interventions for the promotion of a healthy lifestyle that together with counselling~     strategies will include supervised physical exercise of vigorous intensity will present~     greater improvements in terms of metabolic risk, physical condition, physical~     activity/sedentary behaviours and psychological parameters at the end of the intervention and~     at 6-months follow-up than participants in interventions for the promotion of a healthy~     lifestyle that will include counselling plus physical exercise of low-to-moderate intensity~     or interventions based exclusively on counselling.~      It is a three arms controlled randomized clinical trial implemented in the Primary Health~     Care setting and of 10 months duration.~   "
56118|NCT02832440|"~     Although exercise training of haemodialysis patients is associated with generally positive~     outcomes few haemodialysis units routinely offer intradialytic exercise therapy. This is~     often related to financial cost and/or staffing limitations. Home-based programs could be an~     alternative means of providing exercise benefits without associated implementation costs The~     aim of this study was to compare the effects of 4 weeks intradialytic versus home based~     exercise for haemodialysis patients regarding adherence and strength gains.~   "
56119|NCT02832427|"~     Although the first outpatient review following cardiac surgery is conventionally scheduled~     for six weeks after hospital discharge, there is no evidence to support this practice.~     Thirty-day mortality and morbidity rates, which are now widely used as indicators of the~     quality of surgical care, reveal rates that are higher than corresponding in-hospital rates.~     Secondly, the rates for mortality and morbidity occurring up to 6 weeks after surgery are not~     known. The objectives of our study are to determine the postoperative mortality and morbidity~     rates in the 6-week interval between hospital discharge and the first planned specialist~     review after cardiac surgery, and to assess the level of patient satisfaction with current~     practice.~      The study will enrol eligible patients who are undergoing elective and urgent coronary artery~     bypass and/or valve surgery at our institution over a 6-month period and provide them with~     study information. Prior to discharge after surgery, prospective participants will be~     consented and given a questionnaire to take home, complete and bring along to the outpatient~     appointment.~      The investigators will analyse the data to determine the rates and timing of the~     complications, and the impact on postoperative recovery. The investigators will also assess~     the level of patient satisfaction with the current practice.~      Appropriate conclusions either in support of current practice or, a change in practice would~     be drawn..~   "
56120|NCT02832414|"~     The purpose of this study is to determine if a lifestyle change program for obese patients~     who are already receiving continuous positive airway pressure (CPAP) treatment can achieve~     weight loss and overall improvement of obstructive sleep apnea syndrome (OSAS).~   "
56121|NCT02832401|"~     Caffeine is the most used psychoactive drug in Canada, with regular consumption by 88% of the~     adult population, While rates of caffeine consumption are considered to be high in the~     general population, there is some evidence that they may be even higher within schizophrenia~     patients; in a 2006 U.S. study, daily consumption rates of caffeine were nearly double those~     observed in a healthy control population (471.6 mg/day vs. 254.2 mg/day). Furthermore, 13% of~     the schizophrenia population studied ingested more than 1000 mg/day of caffeine, well above~     the 400 mg daily maximum recommended by Health Canada. High doses of caffeine are~     particularly concerning for individuals with schizophrenia; caffeine alters dopaminergic~     activity at post-synaptic neurons through its actions at adenosine A2A receptors, which may~     exacerbate positive symptoms, such as delusions and hallucination. This significant rate of~     consumption is likely due in part to caffeine's actions on the human brain, resulting in~     increased arousal, elevated mood and beneficial effects on a wide-range of cognitive~     processes including verbal working memory, sustained attention, and executive function. These~     areas of caffeine-induced cognitive improvement notably overlap with the cognitive domains~     that are reported to be diminished in schizophrenia. Despite this overlap and the rates of~     caffeine consumption observed within schizophrenia, research reports examining the effects of~     caffeine on cognition and brain activity are all but non-existent in this population. The~     primary objective of this proposal is to compare the effects of caffeine and placebo on brain~     function during cognitive tasks in participants with schizophrenia. While the investigators~     have specific hypotheses for each task, overall the investigators hypothesize that caffeine~     will improve cognitive function (as evidenced by larger ERP amplitudes and/or reduced ERP~     latencies) compared to placebo in schizophrenia patients, with similar effects (albeit~     reduced in magnitude) observed in non-patient healthy controls.~   "
56122|NCT02832388|"~     In this study the investigators aim to identify and include all patients with Primary~     Aldosteronism (PA) diagnosed in the Western and Mid-parts of Norway, to describe the~     characteristics of these patients, to explore the cardiac effects of PA, and to identify the~     long-term patient outcome after treatment. A subgroup of the included PA-patients perform~     Cardiac MRI to assess myocardial function in rest and during stress, myocardial mass and~     myocardial fibrosis, compared to a group of healthy controls.~   "
56123|NCT02832375|"~     This single center, comparative design study will be used to investigate the efficacy of an~     experimental stannous fluoride containing dentifrice in relieving dentinal hypersensitivity~     (DH) after short term use compared with a standard fluoride dentifrice.~   "
56124|NCT02832362|"~     This will be a single-center, randomized, parallel-group, placebo-controlled study to assess~     the local nasal tolerability and safety of multiple administrations of topically~     (intranasally) administered 1146A delivered by a nasal spray applicator in healthy adult~     participants~   "
56125|NCT02832349|"~     The Epilepsy Patient Education (EPE) is very important for the comprehension of the disease~     and its management. The EPE allows patients and caregivers to acquire together some autonomy~     and some skills that will help them live better with the disease.The primary objective of~     this study is to evaluate the impact of a program of educational activities (EA) on the~     quality of life of epileptic patients measured by the validated scale Quality Of Life in~     Epilepsy -31 (QOLIE-31).Investigators hope a difference in improving the quality of life~     score of 25% between the 2 groups.~   "
56126|NCT02832336|"~     Caffeine may be playing a beneficial role in patients with narcolepsy. However, the~     relationship between caffeine and its effects on narcoleptic patients has not been examined,~     and it is also unclear whether caffeine provides a beneficial effect or not. Hence, the aim~     of this study is to assess the effects of caffeine consumption on daytime sleepiness and~     reaction time in narcoleptic patients.~   "
56127|NCT02832323|"~     Patients under hemodialysis treatment are mostly treated by erythropoietin (EPO) through~     erythropoiesis stimulating agents (ESA). The objective of ESA treatments is to maintain the~     hemoglobin level in a therapeutic target around 11g/dl. The EPO dose that is necessary to~     reach this target depends on numerous and imbricated factors such as age, associated~     pathologies, iron status, inflammation. As of today, there is no marker to predict the EPO~     response and Hemoglobin (Hb) level is currently the only and late tool to assess the~     efficacy.~   "
56128|NCT02832310|"~     The aim of this study is to determine the relation between arterial diameter and flow of~     carotis interna, brachial artery and radial artery before and after valsalva maneuver.~   "
56129|NCT02832297|"~     In this 12-month multi-center prospective, site-randomized, two-arm trial, approximately 318~     biologic-naïve subjects with RA who are candidates for treatment intensification due to~     inadequate response to MTX monotherapy will be enrolled at up to 60 study sites.~   "
56130|NCT02832271|"~     The purpose of the study is to evaluate the efficacy and safety of green tea in~     endometriosis.~   "
56131|NCT02832258|"~     Urinary tract infection due to Extended-spectrum beta-lactamase producing enterobacteriaceae~     (E-ESBL UTI) become a frequent problem. A too large variety in the prescription of~     antibiotics for E-ESBL UTI in children and absolute recommendations regarding the optimal~     treatment of E-ESBL is nearly impossible at this time.~      Our aim was to describe the characteristics and treatments of urinary tract infections caused~     by Extended spectrum betalactamase-producing Enterobacteriaceae in children.~   "
56132|NCT02832245|"~     The Computerized Registry of Patients with Venous Thromboembolism (RIETE) is a~     multidisciplinary Project initiated in march 2001 and consisting in obtaining an extensive~     data registry of consecutive patients with venous thromboembolism.~      The main objective is to provide information on the Internet to help physicians to improve~     their knowledge on the natural history of thromboembolic disease, particularly in those~     subgroups of patients who are usually not recruited in randomized clinical trials (pregnant~     women, elderly patients, disseminated cancer, severe renal insufficiency, patients with~     contraindications to anticoagulation therapy, extreme body weight, etc), with the purpose of~     decreasing mortality, frequency of thromboembolic recurrences as well as bleeding~     complications and arterial events.~      As an additional objective RIETE is also aimed to create predictive scores that help~     physicians to better identify patients with high risk of presenting some of these~     complications.~      The primary parameters recorded by the registry comprise details of each patient's clinical~     status, including any coexisting or underlying conditions, and the type, dose, duration and~     outcome (during the first 3 months of therapy) of antithrombotic treatment. Study endpoints~     are clinically recognized (and objectively confirmed) recurrences of VTE, major and minor~     bleeding complications, and death.~   "
56189|NCT02831504|"~     PhenoDM1 will use patient reported outcomes to assess levels of pain, fatigue and quality of~     life in this cohort. Clinical and functional outcomes will look at muscle wasting and levels~     of myotonia. DNA, RNA, serum and CSF samples will be taken from all patients so that~     additional genetic and molecular biomarker analysis can be carried out. A subset of patients~     will undergo detailed sleep studies along with skeletal muscle MRI of the lower limbs. This~     study will complement the work of other groups currently looking at myotonic dystrophy type 1~     using the same outcomes and measures where possible.~   "
56133|NCT02832232|"~     There are different inhibition suboccipital techniques, usually adjuvant of physiotherapy,~     for treatment of patients with chronic neck pain. In our clinical practice, a favorable~     effect is observed on patients with chronic neck pain, but there are no published studies~     evaluating the results of this techniques on pain, mobility and disability.~      The objective of this trial is to evaluate if the suboccipital manual techniques, provides~     further improvement in pain intensity, neck disability, range of motion, on patients with~     chronic mechanical neck pain and rotation deficit of the upper cervical spine, being treated~     with physiotherapy. For this purpose, investigators conduct a double-blind (patient and~     evaluator) randomized controlled trial, in a Public Primary Care Center.~      Seventy four subjects will be randomized (computer application) into three groups:~     Mobilization Group, Maintained pressure Group and Control Group. All the three groups receive~     the same protocolized physiotherapeutic treatment during three weeks and, additionally, the~     Mobilization Group receives six sessions (two sessions in a week during three weeks) of~     translational dorsal glide mobilization technique grade III of the atlanto-occipital joint~     and the Maintained pressure Group receives six sessions (two sessions in a week during three~     weeks) of pressure maintained suboccipital Inhibition technique. The Control Group receives~     the protocolized physiotherapeutic treatment only.~      Pain intensity (VAS), Neck Disability Index (NDI), Range of motion (CROM), will be measured~     at baseline, after treatment period, and three months after discharge from treatment. After~     discharge for treatment the patient subjective opinion about their evolution will be~     collected through a Global Rating of Change (GROC) scale, and evaluation of headache~     disability (HIT-6).~   "
56134|NCT02832219|"~     Molecular hydrogen (H2) effectively tackles obesity-related disorders in animal models yet no~     studies so far investigated the effectiveness of H2 for improving biomarkers of obesity in~     humans. In this double blind, placebo-controlled, crossover pilot trial, the investigators~     will evaluate the effects of H2 intervention on body composition, hormonal status, and~     mitochondrial function in middle age overweight women, with hydrogen administered orally for~     4 weeks.~   "
56135|NCT02832206|"~     This study evaluates in detail efficacy and safety (including neurological safety) of hybrid~     ablation of stand-alone, persistent and long-standing persistent atrial fibrillation (AF). An~     implantable ECG monitor will be implanted to all patients for rhythm monitoring. Neurological~     safety will be assessed by cerebral magnetic resonance, neuropsychological examination and~     periprocedural transcranial Doppler measurement.~   "
56136|NCT02832193|"~     Data on how to avoid POCD are limited. The purpose of this monocentric parallel - grouped~     observational registry is to collect study data of the incidence of postoperative cognitive~     dysfunction (POCD).~   "
56137|NCT02832180|"~     This is an open-label, 2-cycle, multiple-dose, single-sequence study in women of~     child-bearing potential. The primary objective is to assess the effect of BMS-986142 on the~     pharmacokinetics (PK) of Combined Oral Contraceptive Containing Ethinyl Estradiol and~     Norethindrone Acetate.~   "
56138|NCT02832167|"~     The purpose of this study is to determine whether nivolumab is an effective treatment for~     cancer that has advanced or has spread. Various tumor types may be eligible for enrollment.~   "
56139|NCT02832154|"~     This pilot clinical trial studies how well an internet-delivered positive affect (PA)~     intervention works in managing emotion in young adult cancer survivors. An internet-delivered~     PA intervention may teach younger cancer survivors healthy coping skills and help doctors to~     learn more about what effects mood may have on the health and well-being of young adults with~     cancer.~   "
56140|NCT02832141|"~     This pilot study aims to i) represents the feasibility of the study design and ii) to point~     out acute effects of thoracic spine mobilization on skin-blood flow, erythema and the~     sympathetic nervous system.~   "
56141|NCT02832128|"~     The objective of this pilot study is to explore whether repeat doses of AUT00063 can provide~     an indication of improvement in performance of tests across a battery of speech and hearing~     assessments in cochlear implant users.~   "
56142|NCT02832115|"~     The primary objective of the study is to determine the role of transdermal vasodilators as an~     adjunct to parenteral vasodilators in reducing radial artery spasm, improving patient~     comfort, and post procedure radial artery patency during transradial coronary angiograms and~     interventions. The study hypothesis is that transdermal vasodilators will increase radial~     artery size and reduce radial artery spasm as well as improve patient comfort and post~     procedure radial artery patency. This is a single-center, double-blind, randomized,~     placebo-controlled study comparing the effect of transdermal preparations of lidocaine +~     nitroglycerine and lidocaine + placebo on radial artery spasm in patients undergoing~     transdermal coronary angiograms. Prior to the procedure, each patient will be randomized into~     either the control arm, lidocaine + placebo, or study arm, lidocaine + nitroglycerine.~   "
56143|NCT02832102|"~     The purpose of this study is to determine new multiscale signatures for the prediction of~     head and neck cancer (HNC) patients disease outcome, in particular for advanced stage (stage~     III, IV) human papillomavirus (HPV) negative patients and to validate prognostic models for~     overall survival.~   "
56144|NCT02832089|"~     Oral carvedilol administered in escalating doses in patients with atrial fibrillation among~     patients with AF with fast ventricular rate.~   "
56145|NCT02832076|"~     The aim of the study is to evaluate the role of subcutaneous negative pressure drain placed~     for 10 days on wound healing in female obese patients undergoing midline exploratory~     laparotomies for ovarian cancer.~   "
56146|NCT02832063|"~     The purpose of this study is to demonstrate the safety, tolerability and efficacy of B244~     administered over 12 weeks to participants with mild to moderate acne vulgaris relative to~     placebo.~   "
56190|NCT02831491|"~     The main purpose of this study is to evaluate the safety of the study drug ramucirumab in~     combination with weekly docetaxel in participants with stage IV non-small cell lung cancer~     (NSCLC) following disease progression after prior platinum-based chemotherapy.~   "
56191|NCT02831478|"~     To assess the safety of a sunscreen product under supervised outdoor-use conditions with the~     target consumer~   "
56233|NCT02830932|"~     A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Determine the~     Safety and Immunogenicity of an Adenoviral-Vector Based Respiratory Syncytial Virus (RSV) F~     Protein Vaccine (VXA-RSV-f) Expressing Protein F and dsRNA Adjuvant Administered Orally to~     Healthy Volunteers~   "
56147|NCT02832050|"~     Study synopsis Objectives~        -  To determine whether delivering a semi-structured play therapy intervention can improve~          procedure-related anxiety / ability to cope with a procedure / procedure-related pain~          for children and young people.~        -  To determine whether delivering a semi-structured play therapy intervention can improve~          patient experience of blood monitoring.~      Patients~        -  Patients aged 5 - 17 years who are under the care of the rheumatology team.~        -  Patients expected to require at least two blood tests during a 12 week period. Design~        -  Recruitment over 24 weeks with each child in the study for a 12 week period.~        -  20 patients will receive play therapy intervention as outlined in the play therapy~          intervention for blood tests.~        -  20 patients will be the comparator group. They will be offered standard care for blood~          tests.~        -  All children will be offered local anaesthetic cream for each blood test. Blood tests~          will be performed by venepuncture unless specifically requested otherwise by patient.~        -  All children will complete outcome measures at baseline, beginning and end of each~          procedure session and at completion of the study at 16 weeks.~      Outcome Measures~        -  Procedure-related anxiety visual analogue scale (VAS) score - completed by child~        -  Observer procedure-related anxiety VAS score - completed by parent~        -  Procedure-related coping VAS score - completed by child~        -  Procedure-related pain VAS score - completed by child~        -  Patient experience VAS score - completed by child and parent separately~   "
56148|NCT02832037|"~     The objective of the study is to investigate the efficacy, safety and pharmacokinetics of~     four different doses of BI 425809 once daily compared to placebo given for 12 weeks in~     patients with schizophrenia on stable antipsychotic treatment.~   "
56149|NCT02832024|"~     This is a randomized study comparing Stent Versus Direct Atherectomy Versus Angioplasty to~     Treat Lower Limb In-stent Restenosis (superficial femoral or popliteal artery).~   "
56150|NCT02832011|"~     This study aims to compare immunologic parameters of 60 patients who are 1-28 days-aged,~     below 1500-gram body weight, born before 32 weeks of gestational age and fed with eoprotin or~     olive-oil fortified breast milk. Cases will receive same amount of calorie intake either with~     eoprotin or olive oil fortified-breast milk. If investigators identify that olive oil doesn't~     increase proinflammatory cytokines and grant enough weight gain in premature infants at the~     end of the study, investigators will suggest olive oil to replace eoprotin which is a very~     costly breast milk-fortifier.~   "
56151|NCT02831998|"~     The objective of the study is to demonstrate the antimicrobial efficacy of the ZP~     Preoperative Prep on skin flora of the abdomen and inguinal regions of human subjects.~   "
56152|NCT02831985|"~     A large number of children with otitis media undergo surgery with ventilation tubes (VTs)~     placed in the tympanic membrane. This is done to improve hearing and speech development and~     to reduce ear complaints. The long-term results of VTs are unclear. Follow-up care is~     required to assure that the tubes are functional, hearing loss has been corrected, and~     potential complications are properly diagnosed and managed. Guidelines regarding follow-up~     care give different advices concerning when, how and by whom the controls should be made.~      The primary goal of this study is to investigate if follow-up care after surgery with VTs of~     children aged 4-10 years can be done by general practitioners instead of specialists without~     negative consequences for the patient.~      In the study the child`s hearing and speech development, middle ear function, subjective~     complaints and complications will be assessed. User satisfaction and other aspects related to~     the quality of control will also be assessed.~      If the study shows that follow-ups after surgery with VTs can be done on the level of primary~     care without loss of care quality, specialist health care services will be spared and~     cost-effectiveness for the overall healthcare system will improve.~   "
56153|NCT02831972|"~     An Open-Label, 2-Period, Fixed Sequence Study to Determine the Effect of Multiple Oral Doses~     of Itraconazole on the Single Dose Pharmacokinetics of AG 120 in Healthy Adult Subjects.~     Period 1 consists of a single oral dose of AG-120 will be administered at Hour 0 followed by~     PK sampling for 504 hours (21 days). In Period 2, multiple oral doses of itraconazole will be~     administered once daily (QD) for 18 consecutive days with a single oral dose of AG-120~     coadministered at Hour 0 on Day 1. PK sampling for AG-120 will be taken for 504 hours (21~     days) following AG-120 dosing on Day 1.~   "
56154|NCT02831959|"~     The study is a prospective, randomized controlled phase III trial, to test the efficacy,~     safety and neurocognitive outcomes of advanced NSCLC patients, following stereotactic~     radiosurgery (SRS) for 1-10 brain metastases, treated with NovoTTF-100M compared to~     supportive treatment alone. The device is an experimental, portable, battery operated device~     for chronic administration of alternating electric fields (termed TTFields or TTF) to the~     region of the malignant tumor, by means of surface, insulated electrode arrays.~   "
56155|NCT02831946|"~     To investigate the effect of intracutaneous suture closure versus Glue (dermabond) closure at~     cesarean section (CS) on long-term cosmetic and maternal outcome.~   "
56156|NCT02831933|"~     This is a Phase II trial to determine the efficacy and safety of in situ gene therapy and~     stereotactic body radiation therapy (SBRT) used as a window of opportunity treatment before~     nivolumab in patients with metastatic squamous or non-squamous non-small cell lung carcinoma~     (NSCLC) and metastatic uveal melanoma. In situ gene therapy will consist of~     adenovirus-mediated expression of herpes simplex virus thymidine kinase (ADV/HSV-tk) plus~     Valacyclovir therapy.~   "
56192|NCT02831465|"~     Maximal Voluntary Ventilation (MVV) correlates well with maximal exercise capacity and is~     used to assess the ventilatory function during exercise in COPD (Chronic Obstructive~     Pulmonary Disease) patients. Dynamic hyperinflation (DH) often occurs during MVV in COPD and~     is believed to be due to expiratory flow limitation.~      The present study is intended to assess whether DH can also occur during MVV in normal~     subjects without expiratory flow limitation.~   "
56193|NCT02831452|"~     The aim of this study is to determine if there is a correlation between digital palpation,~     perineometry and dynamometry as PFM function evaluation methods in nulliparous without pelvic~     floor dysfunction.~   "
56194|NCT02831439|"~     The goal of this project is to examine the effectiveness and potential cost savings of two~     organizational interventions aimed at reducing the use of ineffective or unproven care among~     women with incident breast cancer.~   "
61352|NCT02763826|"~     The purpose of this study is to determine the optimal transcranial direct current stimulation~     (tDCS) amplitude and electrode montage that is both safe and efficacious~   "
56157|NCT02831920|"~     The current standard for Prostate Cancer (PCa) detection remains taking 10-12 systematic~     biopsies of the prostate. This approach leads to overdiagnosis of insignificant PCa on the~     one hand and underdiagnosis and undergrading of significant PCa on the other. multiparametric~     Magnetic Resonance Imaging (mpMRI) has seen an increasing uptake in the clinics for biopsy~     targeting, but the value in biopsy naive patients remains controversial. With Contrast~     Enhanced UltraSound (CEUS) cancer induced neovascularisation can be visualised with the~     potential to improve ultrasound imaging for prostate cancer detection and localisation~     significantly. The past years numerous studies have been performed with CEUS, all basing~     their results on subjective judgement of the investigator. To overcome these difficulties~     CEUS quantification techniques have been used with encouraging first results. These imaging~     techniques have been proposed to improve the yield of prostate biopsies and possibly~     replacing systematic biopsies.~      In this trial mpMRI imaging and CEUS + quantification are performed before primary biopsy.~     Using a fusion device, targeted biopsies are taken from predefined MRI lesions and CEUS~     lesions, together with standard systematic biopsies in the same patients by separate blinded~     clinicians. The main outcome measure is the per-patient (significant) prostate cancer~     detection rate for each of the biopsy regimens.~   "
56158|NCT02831907|"~     The purpose of this study is to evaluate the possible association between portal vein flow~     pulsatility and acute kidney injury after cardiac surgery. Participants will undergo~     assessment of portal vein flow and intra-renal blood flow using bedside Doppler ultrasound~     before surgery and daily for three days after cardiac surgery.~   "
56159|NCT02831894|"~     Treatment-seeking insomnia sufferers most often present in primary care venues where the~     first and usually only treatment is a prescription for a sedative hypnotic, typically a~     benzodiazepine (BZD) or newer benzodiazepine receptor agonist (BzRA). For some patients,~     short-term or intermittent use provides satisfactory insomnia relief. However, more than 65%~     of individuals who are prescribed hypnotics use them for more than a year, and > 30% remain~     on these agents for more than five years. Whereas some patients may appreciate partial or~     full relief of insomnia symptoms with ongoing hypnotic use, continuous long-term use of these~     agents may not represent optimal therapy. A sizable proportion of insomnia patients who~     participate in non-drug insomnia therapy such as cognitive behavioral insomnia therapy~     (CBT-I) achieve sustained insomnia remission long after a time-limited course of treatment.~     However, it is difficult for most long-term hypnotic users to convert from use of medications~     to a self-management approach. Interventions that combine CBT-I with supervised medication~     tapering (SMT) have shown the greatest promise for achieving this outcome, but almost 50% of~     patients who receive this assistance either fail to discontinue their hypnotics or return to~     them even if they do achieve short-term abstinence. Previous research provides only a~     rudimentary understanding of how to help long-term hypnotic users discontinue their sleep~     aids and successfully manage their insomnia with CBT-I techniques.~      Limitations of existing research include failure to consider how:~        1. the pace of hypnotic withdrawal influences outcomes;~        2. patient characteristics such as belief in the need for sleep medications, and anxiety~          sensitivity moderate outcomes; and~        3. hypnotic withdrawal symptoms and changes in sleep quality mediate outcomes.~      This R34 project will gather key pilot data to address these limitations. Specifically, this~     project will compare the currently recommended tapering pace (25% dose reduction every two~     weeks) to a slower tapering pace (10% dose reduction every two weeks) and a no tapering~     condition to determine the influence of tapering pace on outcomes. The study also will~     examine participants' beliefs about their need for hypnotics, anxiety sensitivity, and~     hypnotic dose, half-life and time used as moderators of outcomes. The influence of hypnotic~     withdrawal symptoms and level of sleep disturbance during withdrawal will be tested as~     mediators of outcomes. Enrollees (N=75) will first complete CBT-I and then will be randomized~     to a tapering pace (n=25 per SMT pace). Target moderators and mediators will be examined to~     assess their influence on outcomes. Primary outcomes will include drop-out rates and hypnotic~     discontinuation rates observed for each SMT pace. Investigators will tally rates of those who~     achieve hypnotic dose reductions during SMT and those who return to hypnotic use by a 3-month~     follow-up as secondary endpoints. Results will inform a future R01-level clinical trial~     focusing on tapering pace, patient characteristics that moderate the effect of tapering pace,~     and psychophysiological processes that mediate the effect of tapering pace. This line of~     research will inform clinical practice by helping to refine guidelines for tapering pace so~     as to provide more successful, person-centered interventions~   "
56160|NCT02831881|"~     A Prospective, multi-center, single-arm post-approval study of the IMPELLA® 2.5 System in Non~     Emergent High Risk PCI patients.~   "
56161|NCT02831868|"~     A non-inferiority study to demonstrate efficacy of the HAVAI minimally invasive device~     compared to standard of surgical care 1st metatarsal osteotomy (SSOC)~   "
56162|NCT02831855|"~     This study is designed to evaluate the efficacy and safety of tofacitinib modified release~     formulation (11mg QD) versus tofacitinib modified release formulation plus continued~     methotrexate treatment in subjects with moderate to severe rheumatoid arthritis who are~     insufficiently responding to their stable dose of methotrexate treatment.~   "
56163|NCT02831842|"~     This non-interventional study will meta-analyze overall survival outcomes among the~     participants with metastatic colorectal cancer (mCRC) with available V-Ki-ras2 Kirsten rat~     sarcoma viral oncogene homolog (KRAS) status, who received firstline treatment with~     bevacizumab containing treatment regimen in routine clinical practice. The study leveraging~     secondary data from existing cohorts in the United Stats of America (USA), Germany,~     Australia, and Denmark.~   "
56164|NCT02831829|"~     The aim of the study is to compare the effect of water-based and land-based exercise~     training, and usual care (no exercise training) in patient with coronary artery disease, on~     exercise capacity, vascular function, arrhythmogenic potential and cardiac autonomic~     function, and markers of neurohormonal activity, activated hemostasis and inflammation.~   "
56165|NCT02831816|"~     The objective of the study is to demonstrate the antimicrobial efficacy of the ZP~     Preoperative Prep on skin flora of the abdomen and inguinal regions of human subjects.~   "
56166|NCT02831803|"~     This study is designed to test the feasibility of asking older adults with high blood~     pressure to supplement their daily diets with walnuts and extra-virgin olive oil.~   "
56167|NCT02831790|"~     The Fontan Education Study is a cluster randomized controlled trial evaluating the impact of~     a novel education program in combination with usual care, versus usual care alone, on~     preparing parents of children undergoing Fontan surgery for the challenges of the~     postoperative course.~   "
56168|NCT02831777|"~     The goal of the study is to test the capability of the CareTaker monitor to calibrate its~     continuous blood pressure readings independently. Currently the device requires another~     approved blood pressure monitor to provide a starting calibration.~      The new control module enables the CareTaker to perform a pressure sweep of the internal~     pressure in the finger cuff. The resulting data is analyzed using a combination of pulse~     analysis/oscillometry approach.~   "
56169|NCT02831764|"~     This study will compare safety, efficacy, and tolerability of a two drug regimen of~     dolutegravir (DTG) plus (+) lamivudine (3TC) administered once daily with DTG plus two~     nucleoside reverse transcriptase inhibitors (tenofovir disoproxil fumarate~     [TDF]/emtricitabine [FTC] fixed dose combination [FDC]) administered once daily in human~     immunodeficiency virus (HIV) 1 infected adult subjects that have not previously received~     antiretroviral therapy. The study is designed to demonstrate the non inferior antiviral~     activity of DTG + 3TC regimen to that of DTG + TDF/FTC FDC and will characterise the long~     term antiviral activity, tolerability and safety of DTG plus 3TC through Week 148.~     Approximately, 700 subjects will be randomised 1:1 to receive DTG + 3TC or DTG + TDF/FTC FDC.~     Subjects will be stratified by screening HIV 1 ribonucleotide nucleic acid (RNA) levels and~     by screening CD4+ (cluster of differentiation 4) cell count.~   "
56170|NCT02831751|"~     This Phase 2 Quadrivalent VLP Vaccine study is intended to replicate and extend the~     immunogenicity and safety results obtained in earlier Phase 1-2 and Phase 2 studies. The~     study is being conducted to evaluate that the immunogenicity profile of the Quadrivalent VLP~     Vaccine meets the US Center for Biologics Evaluation and Research (CBER) licensure criteria~     and to evaluate if the immunogenicity and the safety profile of the Quadrivalent VLP Vaccine~     is acceptable and comparable to that of the FluLaval® Tetra and Fluzone® High-Dose (HD). The~     study will also help to define the optimal dose in this population, establish potential~     competitive advantages, and support the design of future studies.~   "
56171|NCT02831738|"~     Primary outcome measure: Changes in plasma glucose concentration over a 3 hour postprandial~     visit after administration of polydextrose (12g) compared to 0 mg placebo.~      Secondary outcome measure: Changes in gastrointestinal tolerance and acute bowel changes in 3~     days following treatment administration.~   "
56195|NCT02831426|"~     The rationale for present trial conception and design moves forward from the assumption that~     a subcutaneous, pre-pectoral reconstruction by means of soft tissue replacement devices is~     feasible, safe and giving rewarding results when compared to the standard retro-pectoral~     technique. Ahead of that, the trial aims to test if there is a difference in the outcomes~     between a biological and a synthetic material when placed as a support under the mastectomy~     skin flaps, both in terms of immediate complications and of long-term results.~   "
56172|NCT02831725|"~     1. Demographics data;~        2. Nutritional evaluation data;~        3. All biochemical monitoring data during the study period;~        4. All nutritional treatment data will be recorded daily during the study period, including~          actual calorie intake, protein intake, and the proportion of calorie/protein~          administered by EN and/or PN route. The nutritional treatment protocol will be decided~          by the attending physician, the investigator will not intervene.~        5. A blood sample (5 ml) will be drawn from every patient immediately after they enroll~          into the study, and the metabolomics of the samples will be analyzed analysis using a~          combined 800 MHz 1H-NMR-UPLC-MS system. The data will then be used to establish~          metabolic profile baseline.~        6. We will establish a sub-group that contains 20 patients (chosen from enrolled patients~          according to APACHE II scores: 10 patients are APACHE II scores in 21-30). We will take~          one blood sample daily during the whole study period. The plasma sample will be used for~          metabolomics analysis using an 800 MHz 1H-NMR-UPLC-MS system. And the data will be used~          for metabolic dynamic modeling.~        7. Clinical outcomes data, which include: 1) Complications after the operation (intestinal~          fistula, pancreatic fistula, biliary fistula and sepsis, bleeding, nosocomial~          infection); 2) death event; 3) ICU-stay; 4) Length of hospitalization~   "
56173|NCT02831712|"~     This study aims to investigate a possible effect of iron status on temporary build-up of~     non-transferrin bound iron (NTBI) in healthy volunteers upon iron supplementation.~   "
56174|NCT02831699|"~     This study will evaluate subjects with fever and/or rash to determine the percentage of those~     infected by the Zika, Chikungunya, or Dengue virus. The study will also compare the clinical~     signs, symptoms, and lab abnormalities related to each virus, to better specify each virus's~     characteristics.~   "
56175|NCT02831686|"~     The purpose of this study is to test the safety of a combination of study drugs called~     selinexor (KPT-330) and ixazomib (MLN9708) with a low dose of dexamethasone. This study tests~     different doses of the study drug, selinexor to see which dose is safer in people. Depending~     on which group (dose level) you are in, the dose of selinexor will vary, but the ixazomib and~     dexamethasone doses will be the same among the groups.~   "
56176|NCT02831673|"~     This study will compare safety, efficacy, and tolerability of a two drug regimen of~     dolutegravir (DTG) plus (+) lamivudine (3TC) administered once daily with DTG plus two~     nucleoside reverse transcriptase inhibitors (Tenofovir [TDF]/Emtricitabine [FTC] fixed dose~     combination [FDC]) administered once daily in human immunodeficiency virus (HIV) 1 infected~     adult subjects that have not previously received antiretroviral therapy. The study is~     designed to demonstrate the non-inferior antiviral activity of DTG plus 3TC regimen to that~     of DTG plus TDF/FTC FDC and will characterise the long term antiviral activity, tolerability~     and safety of DTG plus 3TC through Week 148. Approximately, 700 subjects will be randomised~     1:1 to receive DTG + 3TC or DTG + TDF/FTC FDC. Subjects will be stratified by screening HIV 1~     ribonucleotide nucleic acid (RNA) levels and by screening CD4+ (cluster of differentiation 4)~     cell count.~   "
56177|NCT02831660|"~     The objective is to collect the safety data of idarucizumab for patients treated with~     dabigatran who require rapid reversal of the anticoagulant effects of dabigatran in cases of~     uncontrolled or life-threatening bleeding or when emergency surgery or urgent procedures are~     required.~   "
56178|NCT02831647|"~     Tolerance and Acceptability of new oral nutritional supplement - AYMES PRAGUE~   "
56179|NCT02831634|"~     Feasibility study for a method allowing identification of tumor mutated epitopes in patients~     with breast cancer or cutaneous melanoma, and quantification of CD8+ T cells specific for~     these tumor neo-antigens in their lymph nodes~   "
56180|NCT02831621|"~     Excess ectopic fat deposition is associated with development of cardiovascular and metabolic~     diseases. This study investigates how lifestyle interventions can have an effect on different~     sites of ectopic fat deposition and cardiovascular or metabolic factors. Moreover, the~     clinical and economic value of exercise to supplement a hypocaloric diet is investigated.~      Endocrinologists of the University Hospital of Antwerp, Belgium, will be recruiting women~     during consultations. Also, recruitment posters will be used in the University Hospital of~     Antwerp and the University of Antwerp. Potential participants meeting all a priori set~     inclusion and exclusion criteria will be randomized by minimization method to a hypocaloric~     diet group (usual care) or a group of hypocaloric diet combined with physical fitness~     training. Both groups will undergo an intake procedure in which personal goals are set and~     barriers to changes in behavior will be discussed. Ectopic fat deposition will be measured by~     imaging techniques after three and six months of intervention. A post-intervention follow-up~     period of six months is planned. Based on the known relationship between ectopic fat and~     cardiovascular outcomes, the short term study results will then be extrapolated to an~     estimation of the reduction of cardiovascular events.~      The following clinical outcomes will be presented: change in ectopic fat in the abdomen~     (visceral fat), the liver (intra hepatic lipids), skeletal muscle (intra myocellular lipids),~     heart (epicardial fat) after a dietary or combined (diet+physical activity) intervention. The~     impact of supervised exercise in addition to diet will be expressed in projected healthcare~     costs and quality adjusted life years.~   "
56196|NCT02831413|"~     This project will test the effectiveness of offering healthy marriage and relation education~     for youth as part of the regular school curriculum and examine whether providing enhanced~     training and support for facilitators shows promise for enhancing the effects on high school~     students. The evaluation will examine a range of students' relationship outcomes, including~     their attitudes toward relationships, their knowledge of healthy relationships, their~     communication skills, and the characteristics of their current relationship.~   "
56197|NCT02831400|"~     The purpose of this study is to detect changes in circulatory I-FABP values (50% increase) in~     elderly volunteers following the combination of moderate physical activity and a standard~     meal.~   "
56198|NCT02831387|"~     The purpose of this study is to evaluate the effect of treatment with 0.017% P-321 on Dry Eye~     Symptoms.~   "
56261|NCT02830542|"~     The study will involve administering a single dose of investigational drug or placebo in~     ascending dose cohorts. This study is designed to evaluate the safety and tolerability of~     investigational drug as well as the efficacy of investigational drug versus placebo in adults~     with primary (first episode) Clostridium difficile infection (CDI).~   "
56181|NCT02831608|"~     Background. For more than a century a causal link between influenza and cardiovascular~     disease has been suspected. It is conceivable that influenza may precipitate plaque rupture,~     increase cytokines with central roles in plaque destabilization and trigger the coagulation~     cascade. Accordingly, registry studies, case control studies and a few small randomized~     trials, all underpowered for clinical endpoints, have demonstrated that the risk for acute~     myocardial infarction (AMI) is increased following respiratory infection and that the risk of~     stroke and AMI in patients with established cardiovascular disease seem to be reduced~     following influenza vaccination. In May 2015 a Cochrane review concluded that influenza~     vaccination may reduce cardiovascular mortality and cardiovascular events but bias and~     inconsistent results in prior studies require higher-quality evidence to confirm these~     findings. High costs and little commercial interest in conducting a randomized trial on~     influenza vaccine in cardiovascular disease stand in the way.~      Objective. The objective is to document whether influenza vaccination protects against~     cardiovascular events and death after an AMI.~      Methods. Population: 4400 patients with ST-elevation (STEMI) or non-ST elevation myocardial~     infarction (NSTEMI) are randomized 1:1 in a blinded fashion using an RRCT design and followed~     up via registries and two telephone calls. Intervention: Influenza vaccination. Control:~     Placebo (saline). Outcome: The primary endpoint is a composite of death, myocardial~     infarction and stent thrombosis till 1 year in patients with STEMI/NSTEMI undergoing coronary~     angiography/PCI. Patients will be included in the study in all of Sweden's 7 university~     hospitals and 2 general hospitals, 4 university hospitals and 1 general hospital in Denmark,~     in 1 specialized heart center in Norway, 3 university hospitals in Czech Republic, 5~     hospitals in Scotland and 1 university hospital in Latvia. Secondary endpoints are time to~     all-cause death, time to stent thrombosis, time to revascularization, time to myocardial~     infarction, time to stroke or time to rehospitalization for heart failure till 1 year, 2~     years, 3 years and 5 years. Furthermore, an extensive health-economic analysis will be~     conducted. The trial has been approved by the ethical committee system (Dnr 2014/264) and the~     Medical Products Agency (EudraCTnr -2014-001354-42) in Sweden.~      Perspectives. If a clinical benefit can be demonstrated in this prospective trial influenza~     vaccination may become an important novel in-hospital therapy for patients with~     cardiovascular disease and the accompanying direct and indirect societal gains will be~     profound. IAMI will be the first placebo-controlled RRCT conducted.~   "
56182|NCT02831595|"~     Modern knee implants combine several types of metal and therefore potentially expose patients~     to different metal ions.~      Titanium niobium nitride coating (TiNbN) acts like a physical barrier against the corrosion~     process and the metallic ions release towards the surrounding biologic environment, thus,~     making TiNbN-coated prostheses possible to be safety implanted in metal sensitized patients.~      The aim of the study is to verify that the postoperative plasma metal concentrations at 1~     year are not different than preoperative values.~   "
56183|NCT02831582|"~     This clinical trial studies the use of omega-3 fatty acid supplementation in preventing~     aromatase inhibitor-induced toxicity in patients with stage I-III breast cancer. An omega-3~     supplementation may help relieve moderate to severe bone pain and improve joint symptoms~     caused by aromatase inhibitor-induced arthralgias.~   "
56184|NCT02831569|"~     This is an open-label, single-group, multi-centre trial to confirm the safety and efficacy of~     loxoprofen sodium/methocarbamol ( IP-TN) when administered orally for 2 weeks to patients~     with low back pain, scapulohumeral periarthritis, or cervico-omo-brachial syndrome associated~     with muscle strain. More than 90 patients will be screened to enroll approximately 80~     patients in the trial.~      After giving written informed consent, patients will be enrolled in the trial. Patients who~     are considered eligible for the trial by the Investigator after consent and complete the~     trial procedures and assessments at Visit 1 will receive the trial medication and enter the~     open-label treatment period of 2 weeks. Patients who complete the open-label treatment period~     will enter the follow-up period of 1 week and complete the trial after confirmation at the~     last visit (or phone interview).~   "
56185|NCT02831556|"~     Summary~        1. Purpose and Objective: The purpose of this study is to test the feasibility of rapid~          acquisition of point of care 3D ultrasound in obtaining abdominal and/or pelvic images.~          The study will use a newly developed acquisition method and post-processing technique to~          create three dimensional image models of the abdomen and/or pelvis.~        2. Study activities and population group. The study population will be a convenience sample~          of patients of any age presenting to the Emergency Department with complaints~          necessitating a clinical abdominal and/or pelvic imaging. The study intervention~          includes acquisition of research ultrasound images, which will not be used for clinical~          care, and comparison of these images with clinically obtained images. Other clinical~          data such as surgical and pathology reports will also be reviewed. 3.Data analysis and~          risk/safety issues. This is a pilot study intended to determine feasibility and to~          refine image reconstruction algorithms. Research images will be compared to clinical~          images. Comparison of research images with final diagnosis will also occur. The research~          intervention, an ultrasound exam, has no known safety risks. The only risk to subjects~          is loss of confidentiality.~      This study is observational, not interventional, because the experimental ultrasound will be~     performed in all subjects and will not be used in the clinical care of patients~     (consequently, will not have the opportunity to affect clinical outcomes). Experimental~     images will be reviewed after completion of clinical care and will not be provided to the~     clinicians caring for the subjects. The investigators are not measuring the effect of the~     ultrasound examination on the subjects' outcomes.~   "
56186|NCT02831543|"~     A phase Ⅲ, multi-center, randomized, double-blinded, placebo and active comparator clinical~     trial to assess the efficacy and safety of combination therapy of Motireb 5/100 mg in~     functional dyspepsia patients.~   "
56187|NCT02831530|"~     Cyclins CDK4 / 6 are extensively involved in the proliferation and growth of numerous cancers~     including breast cancer. The objective of this study is to identify if a new preoperative~     oral treatment, abemaciclib directed against the CDK / 6 compared to no treatment, inhibits~     tumor growth or induced senescence (aging) tumor.~      This early study is offered to women who are going to be operated on for breast cancer with~     expression of hormone receptor (ER and / or PR). These women will have 3 chances to receive~     one for up to 14 days in the waiting period of their surgery abemaciclib as tablets. Other~     patients do not receive treatment. The decision to receive or no treatment will be done by a~     random computer draw.~      The drug's effectiveness will be evaluated primarily on the biological parameters of the~     tumor itself when comparing surgery to before treatment. These results biomarkers will allow~     us to better know how this treatment and eventually will be used in future to identify~     patients for whom treatment with abemaciclib more efficiency.~      Patients treated in the protocol will then receive treatment entirely conventional in their~     breast cancer within the parameters of their tumors: their participation is very limited in~     time.~   "
56188|NCT02831517|"~     The primary objectives of this study are: To evaluate pharmacokinetics (PK) properties of~     BIIB074 administered as a single oral dose in healthy Japanese and Caucasian participants;~     and To evaluate the PK properties of BIIB074 administered as repeated oral doses in healthy~     Japanese participants. The secondary objective of this study is to assess the safety and~     tolerability of BIIB074 administered as a single oral dose (Japanese and Caucasian~     participants) and as repeated oral doses (Japanese participants).~   "
56199|NCT02831374|"~     Purpose: This prospective randomized comparative clinical study was conducted to assess the~     effect of platelet-rich plasma (PRP) gel on soft tissue healing and bone regeneration~     potential on lower third molar extraction sockets.~      Methods: For the study, 50 Patients (37 male, 13 female) requiring surgical removal of a~     lower impacted third molar and who fulfilled the inclusion criteria were recruited. The~     patients were categorized into two groups, Group A and Group B. For each group 25 patients~     were randomly allocated. The predictor variable in Group A was the application of PRP Gel~     whereas in Group B had no PRP. Postoperative pain, swelling, trismus, soft tissue healing and~     osseous regeneration was assessed using standard methods. These outcome variables were~     assessed on 1, 3-, 5-, 7-, and 14-postoperative day. Patients were recalled at the 4th, 10th,~     and 16th postoperative week for assessment of bone healing. The data were recorded and~     tabulated.~   "
56200|NCT02831361|"~     The objective of this study is to evaluate the efficacy and safety of gemigliptin 50 mg~     orally administered once daily for 24 weeks compared with placebo in patients with type 2~     diabetes mellitus who have inadequate glycemic control on insulin alone or on insulin in~     combination with metformin stably for 8 weeks.~   "
56201|NCT02831348|"~     This is a pilot cross-sectional study of measured transcutaneous CO-oximetry in children with~     inflammatory and non-inflammatory conditions.~   "
56202|NCT02831335|"~     The purpose of the study is to investigate the associations of the age-related changes in the~     brain, kidneys and cognitive performance in healthy adults by utilizing multiple anatomic and~     functional MRI methods along with a battery of cognitive tests.~   "
56203|NCT02831322|"~     Several approaches have been proposed to reduce the risk of RAO, including anticoagulation,~     immediate postprocedural sheath removal, and a small sheath/radial artery ratio. Doppler~     ultrasound examination showed that interrupted blood flow in RA tend to occur in the proximal~     end rather than distal part of the artery,which was ignored by a majority of interventional~     cardiologists. Different insights into occlusion location may lead to different options of~     sheath materials, models, catheters and puncture access. Thus, the investigators designed~     this present study to explore the reason of radial artery endothelial dysfuction and damage~     and occlusion location by ﬂow-mediated dilation (FMD) to determine the suitable method to~     reduce occlusion risk during TRI.~   "
56204|NCT02831309|"~     ACS examined the potential influence of intermittent physical activity breaks of various~     intensities (control, light, moderate, vigorous) on measures of immediate mental performance,~     mood, hunger and several metabolic outcomes in children aged 7-11 years. We build upon~     previous work to hypothesize that higher-intensity intermittent physical activity breaks~     throughout an 8-hour day will improve immediate mental performance, mood, and post-exercise~     physical activity levels, while reducing hunger and post-exercise food intake.~   "
56205|NCT02831296|"~     SPOT SMA is a prospective NIH-supported clinical study targeting pre-symptomatic or recently~     diagnosed infants and children with Spinal Muscular Atrophy (SMA) types 1, 2, or 3 and their~     healthy control siblings less than 36 months of age at the time of study enrollment. The main~     objective of the study is to prospectively collect longitudinal clinical outcomes and provide~     counseling and education to parents of newly diagnosed children. The study will assess the~     impact of current standard of care management paradigms and interventions on health outcomes~     in newly diagnosed SMA infants and children with type 1, 2 or 3 and age appropriate controls.~     There is no investigational drug and no specific intervention in this study. Rather, the~     investigators will document outcomes related to current therapies provided to participating~     subjects, and will educate participants about possible clinical trial opportunities.~   "
56206|NCT02831283|"~     This study is being done to learn about inflammation and amyloid in Alzheimer's disease. A~     type of brain scan called a PET scan is used measure 1) inflammation and 2) abnormal~     accumulation of a the amount of a certain protein fragment called beta-amyloid (plaques) in~     the brain. These are thought to be involved in Alzheimer's disease. The investigators will~     also perform brain MRI and do tests to measure the participants' memory and thinking.~   "
56207|NCT02831270|"~     Serum-creatinine level (s-Cr) is an important factor for predicting perioperative patient's~     outcome regarding acute kidney injury. Although cardiopulmonary bypass (CPB), an essential~     procedure for cardiac surgery, dilutes patient's blood components, possible impact of~     applying acute normovolemic hemodilution (ANH) and CPB on s-Cr has not been well~     investigated.~      In patients undergoing cardiac surgery employing moderate hypothermic CPB (age 20-71 years,~     n=32), ANH will be randomly applied to 15 patients (Group-ANH) but not in 17 patients~     (Group-C) before initiating CPB. For ANH procedure consisting of 5 ml/kg of blood salvage and~     administering 5 ml/kg of balanced hydroxyethyl starch (HES) 130/0.4 for 15 min will be~     started at 30 min after anesthesia induction and before CPB application for surgery. In both~     groups, moderate hypothermic CPB will be initiated by using 1600-1800 ml of bloodless priming~     solution. The changes of hematocrit (Hct), Na+, K+, HCO3-, Ca2+, osmolarity, s-Cr will be~     determined before ANH (T1), after the first ANH of 2.5 ml/kg (T2), and after the second ANH~     of 2.5 ml/kg (T3), 30 sec and 60 sec after the initiation of CPB (T4, T5), immediately and 1~     hour after the weaning from CPB (T6, T7) and at the end of surgery (T8). S-Cr will be~     determined by using a point-of-care test device (StatSensor™ Creatinine, Nova Biomedical,~     USA).~   "
56208|NCT02831257|"~     The goal of this clinical research study is to learn if the study drug AZD2014 can shrink~     growing or symptomatic meningiomas.~   "
56209|NCT02831244|"~     The purpose of this study is to evaluate the performance of the Agili-CTM implant in the~     treatment of osteoarthritis of the Great Toe.~   "
56210|NCT02831231|"~     This study is intended to determine whether the addition of trospium chloride to xanomeline~     tartrate will ameliorate the peripheral cholinergic side effects that have been previously~     experienced with xanomeline tartrate when administered alone.~   "
56211|NCT02831218|"~     The purpose of this study is to compare clinical outcomes between QCA(quantitative coronary~     angiography)-guided and imaging-guided strategy in patients with native coronary artery~     disease undergoing Bioresorbable Vascular Scaffold implantation.~   "
56212|NCT02831205|"~     The purpose of this study is to determine whether ABSORB bioresorbable vascular scaffold is~     non-inferior to XIENCE everolimus-eluting cobalt-chromium stent with respect to target-lesion~     failure (TLF) at 1 year.~   "
94107|NCT02335346|"~     The purpose of this study is to assess the safety and efficacy of duloxetine in participants~     with osteoarthritis and knee pain. The study will last for 1 year.~   "
56214|NCT02831179|"~     This phase I trial studies the side effects and best dose of veliparib when given together~     with capecitabine and temozolomide in treating patients with neuroendocrine tumor that has~     spread to other places in the body and usually cannot be cured or controlled with treatment,~     has returned after a period of improvement, and cannot be removed by surgery. Veliparib may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs~     used in chemotherapy, such as capecitabine and temozolomide, work in different ways to stop~     the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading.~   "
56215|NCT02831166|"~     Primary percutaneous coronary intervention represents the gold standard for the treatment of~     ST-segment-elevation acute myocardial infarction. However, periprocedural bleedings are~     associated with an increased risk of mortality, re-infarction, and stroke. Although the~     prognostic value of access site related bleeding complications is still debated, transradial~     approach is associated with better short-term outcomes and reduced hospital stay as compared~     to transfemoral approach. The investigators aimed to compare transradial approach with~     transfemoral approach with systematic achievement of hemostasis by the implantation of a~     vascular closure device in a national multicentre randomized clinical trial.~   "
56216|NCT02831153|"~     This study evaluates the effects of emotional status on coronary flow in patients undergoing~     elective coronary angiography. Patients whom undergoing elective coronary angiography will~     fulfill the Beck Anxiety Inventory, Beck Depression Inventory, State-Trait Anxiety Inventory,~     Hospital Anxiety and Depression Scale. State Anxiety Inventory will be fulfilled both before~     the intervention and after 1 hour the patients learned the results of the coronary~     angiography. The other scales will be performed after 1 hour the patients learned their~     results. Coronary flow will be assessed by TIMI (Thrombolysis In Myocardial Infarction) frame~     count method.~   "
56217|NCT02831140|"~     This prospective, randomized study is designed to evaluate the effectiveness of postoperative~     care pathway using the Fast Track Rehabilitation protocol (FTR) in comparison with the~     traditional postoperative care.~      In order to conduct this study, patients having a thoracic surgery will be randomly~     attributed to FTR protocol group or control group.~   "
56218|NCT02831127|"~     Plastic and covered metal stents need to be removed or exchanged within appropriate time in~     case of undesirable complications. However, it is not uncommon that patients does not follow~     the recommendation for further stent management after ERCP. we hopothesized that short~     message service (SMS) intervention monthly could improve the adherence in patients with~     benign pancreaticobiliary after ERCP.~   "
56219|NCT02831114|"~     Taxane Induced Peripheral Neuropathy (TIPN) is a major dose limiting side effect of taxane~     chemotherapies and it often reduces the success of the patient treatment. Treating TIPN is~     difficult and at this time conventional treatment is primarily limited to the global use of~     antidepressants and anticonvulsants. Acupuncture treatment has been used for symptom~     improvement in patients with peripheral neuropathy caused by HIV and diabetes mellitus;~     however, few studies have evaluated acupuncture as a viable treatment for taxane induced~     peripheral neuropathy. This study will enroll female breast cancer survivors at the~     Greenville Health System Cancer Institute Center for Integrative Oncology and Survivorship to~     assess whether acupuncture holds any therapeutic benefit for TIPN and how it influences the~     mechanisms underlying resolution of TIPN. This would provide critical validation of~     acupuncture and increase potential for other forms of chemotherapy induced peripheral~     neuropathy.~   "
56220|NCT02831101|"~     We compared BIS values during propofol stepwise induction with or without concomitant~     sufentanil in patients ≥ 65 years .~   "
56221|NCT02831088|"~     Efficacy and safety of Neu2000, a multi-target drug designed to prevent both NMDA~     receptor-mediated excitotoxicity and free radical toxicity, will be investigated in acute~     ischemic stroke patients receiving endovascular treatment to remove clot within 8 hours~     following stroke onset. Neu2000KWL will be administered before endovascular treatment.~   "
56222|NCT02831075|"~     Stem cell therapy has been a new and effective therapy in recent years for diabetic foot.This~     study intends to establish an optimal clinical research program, and attempts to break the~     technical bottleneck in the stem cell therapy for treating diabetes related vascular~     complications.~   "
56223|NCT02831062|"~     This study will evaluate patients who have an episode of moderate to severe acute kidney~     injury (AKI) and are followed in a focused post-AKI clinic. After patients present signs of~     kidney recovery and before hospital discharge, patients who give consent will be enrolled in~     the study. At the first post-AKI clinic visit, patients will be randomly allocated to follow~     a normal (ad-lib) or a low protein diet (LPD) for 3 months. Patients allocated to a LPD will~     receive a drug called Ketosteril. This drug allows the intake of essential amino acids while~     minimizing the amino-nitrogen intake, what in excess, can be bad for the recovered kidney.~     The investigators will evaluate the nutritional parameters and the kidney recovery of all~     patients and compare these parameters in those two groups.~   "
56232|NCT02830945|"~     American Indians (AI's) are experiencing an epidemic of stroke morbidity and mortality, with~     higher prevalence and incidence, younger age at onset, and poorer survival than other racial~     and ethnic groups. With a stroke incidence more than twice that of the general U.S.~     population, stroke in AI's is a public health problem of staggering scope. AI's also have~     disproportionate burdens of many risk factors for stroke, including hypertension, smoking,~     obesity, and diabetes. However, no rigorous, population-based studies of stroke prevention~     have included AI's. The investigators at WSU, and community partners, have designed the~     Family Intervention in the Spirit of Motivational Interviewing (FITSMI), a program~     delivered at the household level to encourage lifestyle changes that transform the home~     environment and reduce stroke risk for all residents. FITSMI uses a talking circle format~     in which facilitators guide participants to identify goals for change and create a tailored~     plan for sustainable implementation that may target smoking, exercise, diet, or medication~     adherence. FITSMI requires just 2 sessions (baseline and 1 month post-baseline), with text~     messaging used to boost long-term adherence. In a group-randomized trial design, the~     investigators will recruit 360 households where Strong Heart Family Study members aged 45 and~     older reside. The investigators will assign half to FITSMI and half to a control condition~     that receives educational brochures.~   "
65622|NCT02708056|"~     The objective of this study is to evaluate the efficacy and safety of sugammadex in reversing~     profound neuromuscular block induced by rocuronium in infant patients~   "
56224|NCT02831049|"~     Background:~      Sights, sounds, and smells can be associated with alcohol and tempt people to drink. The~     connection between encountering cues and wanting to drink might be reduced by behavioral~     techniques, like giving the cues at certain times, in certain circumstances.~      Objective:~      To see if visual imagery and behavioral techniques can reduce alcohol craving and drinking.~      Eligibility:~      Healthy people ages 21 65 who are mildly concerned about their drinking and have had these~     habits in the past 3 months:~      Women: More than 3 drinks any single day and more than 7 drinks per week~      Men: More than 4 drinks any single day and more than 14 drinks per week~      Design:~      Participants will be screened with medical history, physical exam, blood tests, alcohol~     breath tests, hepatitis tests, and alcohol and drug use questionnaires.~      Participants will get a smartphone to carry throughout the study. They will use it to report~     on their drinking, moods, and activities daily. The phone s GPS will record their locations~     throughout each day.~      There will be 6 study visits over 4 weeks. Visits will last up to 4 hours, but the final~     visit lasts up to 7 hours. Visits include the following:~      Not drinking alcohol or using illicit or over-the-counter drugs at least 24 hours before each~      visit~      Providing urine and breath samples.~      Exposure to various cues. Participants reactions will be monitored by measuring heart rate,~      blood pressure, and skin temperature.~      Drinking alcohol or soft drinks. For visits with alcohol, transportation to and from the~      visit will be provided.~      About a month after the last visit, participants will be called to ask about their drinking~     and cravings.~   "
56225|NCT02831036|"~     20 healthy man, 10 in trial group and 10 in control group (randomly divided) will participate~     in the experiment on order to evaluate if improvement in physical fitness influences spatial~     learning in humans.~   "
56226|NCT02831023|"~     The purpose of this study is to determine the most efficacious transmission blocking drug~     regimen for seasonal malaria chemoprophylaxis in Mali. The primary outcome measure will be~     the proportion of mosquitoes infected pre and post-treatment, assessed through membrane~     feeding and measured by oocyst prevalence in mosquitoes dissected on day 7 post feed. Primary~     endpoint will be a within group comparison between the mean of the pretreatment infectivity~     (Day 0) and infectivity at 7 days post first dose.~   "
56227|NCT02831010|"~     The purpose of this study is to explore the perinatal risk factors of encephalopathy of~     prematurity and the morbidity of the following neurodevelopmental impairments in preterm~     infants with gestational age <32 weeks in China.~   "
56228|NCT02830997|"~     In total knee replacement operations, the surgeon uses techniques and instruments to guide~     the operation and ensure that all parts of the prosthesis (the artificial knee surfaces) are~     placed into the correct position. There are many techniques a surgeon can use to achieve~     accuracy in the operation. This study will compare the Principal Investigator's present~     precision-guided technique and instrumentation methods with a newly developed technique that~     uses a computer-based stereotactic guidance system. The purposes of the study are: 1.) to~     learn whether the use of the different guidance systems results in differences of accuracy of~     the placement of the prosthesis; 2.) to compare the length of time it takes an experienced~     joint replacement specialist to complete the operation using the different guidance systems;~     3.) to learn whether there are advantages of either system in terms of the function and~     recovery of patients over the first year after surgery; and, 4.) to provide the manufacturer~     of the stereotactic guidance system with feedback on the technical ease of use and workflow~     ease of the system which may be used for training and education purposes and/or for planning~     further refinements to the system. The study will enroll up to 150 patients from Athens~     Orthopedic Clinic over 2 to 3 years.~   "
56229|NCT02830984|"~     Endoscopic retrograde cholangiopancreatography (ERCP) has become one of the most important~     techniques in the treatment of bile duct stones. A number of studies have been conducted~     using large-balloon dilation (LBD) after adequate EST to extract large bile duct stones. In~     those studies, the authors suggested that EST plus LBD might lower the risk of post procedure~     pancreatitis (PEP) by directing balloon dilation toward the bile duct rather than the~     pancreatic duct. It has been reported that EPBD followed by insertion of nasobiliary drainage~     catheter can prevent PEP. However, it is still unclear that nasobiliary drainage after~     endoscopic sphincterotomy plus large-balloon dilation for preventing postoperative~     pancreatitis in treating of large bile duct stones.The investigators therefore designed a~     prospective randomized trial to determine whether nasobiliary drainage prevent PEP after~     endoscopic sphincterotomy plus LBD for the treatment of large bile duct stones.~   "
56230|NCT02830971|"~     The nurses were learned the theoretical and practical skills previously during their~     studentship period. The procedures will be the first time the nurses wanted to perform in~     ICU. All clinical situations including patient, procedure, and shift will be similar for~     nurses. The end point will be reaching to the 95 score of learning curve. The reason for~     selection less than 5 percent variation was the flattening of learning curve (the plateau~     section).~   "
56231|NCT02830958|"~     The hip is a commonly performed operation. It is a prosthetic joint replacement surgery whose~     effectiveness depends on the quality of architectural and mechanical reconstruction of the~     artificial hip, integrity and balance of the periarticular musculature. To achieve this dual~     purpose, two elements are essential: access to the hip that best meets the musculature and is~     able to restore the balance, and adequate prosthesis.~      Despite the move towards a surgery less invasive hip replacement is a procedure that causes~     tissue damage. This results in nociceptive and neuropathic pain, which can become chronic in~     about 30% of cases.~      Several studies have shown that there are risk factors for chronic post-surgical pain. They~     are both related to patients but also to surgery.~      Puolakka in his study correlates chronic pain and post-surgical acute pain following surgery~     in surgical patients with total knee arthroplasty. Indeed, post-operative acute severe pain~     multiplies by 10 the risk of developing chronic pain.~      It is thus advantageous to reduce the postoperative pain, localized mainly in the~     trochanteric region, to decrease the risk of developing chronic post surgical pain. Now~     medical comunity know that the post-operative bruising and tissue damage are partly~     responsible for these pains.~      The Kinesiotaping uses an adhesive elastic cotton tape color invented by Dr. Kase in the~     1970s It is water resistant and retains its properties up to 5 days.~      It has the characteristic to cause elevation of the epidermis and thereby reduce the pressure~     on the mechanoreceptors below the dermis. This would have the effect of reducing nociceptive~     stimuli.~      Its designers also claim it would have a beneficial effect on the lymphatic and venous~     circulation. According Kase Kinesiotaping causes an uprising of the epidermis decreasing the~     pressure in the dermis and promoting lymphatic drainage through its mechanical action during~     movement.~      The lymphatic system is responsible for the capture of waste from venous blood (catabolites,~     plasma proteins) and thus can promote the absorption of edema.~      In his study, Donec highlights a significant decrease in pain and a higher absorption of~     postoperative edema in the Kinésiotape® group than in the control group in surgical patients~     with total knee arthroplasty .~      The Curetape® band is used in the orthopedic surgery department since 2010 in current care.~      Consequently, it seems interesting to evaluate the effect of Curetape® in surgical patients~     with a total hip replacement.~   "
56234|NCT02830919|"~     This phase III clinical study will be conducted in Brazilian research sites. It will be~     included in the study 314 participants diagnosed with primary knee OA according to the~     classification criteria of the ACR. After a washout period, the participants will be~     randomized to receive the combination of glucosamine sulfate + chondroitin sulfate of bovine~     origin of Eurofarma Laboratorios S.A. (N= 157) or the combination of glucosamine sulfate +~     chondroitin sulfate of Zodiac Pharmaceuticals S.A. Condroflex ® (N = 157). The treatment~     period of the study will be of 24 weeks. Each participant will perform seven visits to the~     research site. The main evaluations will be the improve of pain in the target knee by~     questionnaire Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and~     quality of life by SF-12 questionnaire.~   "
56235|NCT02830906|"~     We would like to know the prophylactic anti-emetic effect of ramosetron compare to~     ondansetron in patient undergone total knee arthroplasty with spinal anesthesia and~     intrathecal morphine .~   "
56236|NCT02830893|"~     This study will test the effectiveness of a new lever drive wheelchair, LARA - Lever Actuated~     Resonance Assistance. LARA facilitates patients in performing a high amount of practice using~     their moderate to severely impaired upper extremity after stroke.~      Investigators will recruit 44 subjects with subacute strokes to participate in the study~     through the acute rehabilitation unit of the UC Irvine Douglas Hospital. Study participants~     will be randomized into 2 groups: LARA therapy group or standard therapy group. The LARA~     therapy group will use LARA to propel themselves to therapy appointments in the unit and to~     play video games with the affected upper extremity for 30 mins / day. The standard therapy~     group will use a standard wheelchair to propel themselves using their unaffected upper and~     lower extremities. They will be asked to perform a matched duration of standard arm exercises~     for 30 mins/ day. This program of standard arm exercises was developed by an OT at the~     Rehabilitation Institute of Chicago which consists of graded-difficulty table-supported~     exercises.~      This study will have 3 assessment visits: baseline, 3 weeks after therapy or upon discharge~     from the acute rehabilitation unit if sooner, and a 3-month follow up.~   "
56237|NCT02830880|"~     The purpose of this study is to assess if using~     anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid (FACBC or fluciclovine) PET scan will~     be useful in determining if participants are responding to chemotherapy treatment.~      Investigators will enroll participants whose cancer has been treated with hormone therapy and~     now the cancer is not responding to the treatment (Castration -resistant), and so therefore~     will be started on chemotherapy. Investigators will enroll thirty (30) participants in this~     study.~   "
56238|NCT02830867|"~     The glutathione synthetase deficiency, inborn error of metabolism of autosomal recessive~     inheritance, is a rare disease (70 patients described in the world). The outcome of these~     patients and potential complications of this disease are not, to date, yet all known and~     described.~   "
56239|NCT02830854|"~     A variety of non-pharmacological interventions have been used in the management of~     Alzheimer's disease (AD) and similar cognitive disorders in elderly, yet no therapeutic~     modality has demonstrated conclusive positive results in terms of effectiveness. Although it~     is still unknown what triggers AD, recent studies have shown that AD is associated with brain~     energy depletion, oxidative stress, and mitochondrial dysfunction. Since supplemental~     molecular hydrogen (H2) supports cell energy production and acts as a highly bioavailable~     mitochondria-related antioxidant, it may provide an ideal agent to facilitate treatment and~     perhaps prevention of AD and similar cognitive disorders in elderly. The overall hypothesis~     to be evaluated in this project is that administration of H2 will positively affect~     patient-reported outcomes and clinical biomarkers in men and women suffering from AD.~   "
56240|NCT02830841|"~     Remote ischemic preconditioning(RIPC) is emerging as an promising therapeutic paradigm to~     combat the detrimental impact of ischemic and reperfusion injury. In liver transplantation,~     ischemic and reperfusion injury severely impacts the post-surgery liver function and patient~     outcome. This prospective, double blind, randomized clinical trial is aimed to test the~     protective effect of RIPC against hepatic ischemic and reperfusion injury in pediatric liver~     transplantation.~   "
56241|NCT02830828|"~     INTRODUCTION Carpal tunnel syndrome (CTS) is a common condition that results in impaired hand~     function. In cases of CTS the pinch grip force between the thumb and index finger becomes~     unnecessarily high to prevent objects from slipping when they are picked up.~      HYPOTHESES The proposed study will investigate the following hypotheses regarding CTS.~      As an object is picked up, the investigators suspect there will be several points at which~     grip force will be different between patients with different severities of CTS, i.e. grip may~     deteriorate as CTS gets worse.~      The investigators also suspect grip force will be affected depending on the weight of the~     object, i.e. patients with CTS may struggle with objects of a certain weight.~      Patients with CTS sweat less, and this may affect their grip. The investigators suspect that~     pinch grip in CTS patients is disproportionately altered by the frictional properties of the~     object and by the moistness of the skin.~      The investigators suspect patients with CTS will be less able to adapt to sudden changes in~     an object's weight.~      The investigators wish to examine how the above are affected after surgical treatment of CTS.~      METHODS The investigators will include patients with symptomatic, idiopathic CTS, aged~     between 18 and 80 years. The investigators' centre will recruit CTS patients who will attend~     their National Health Service (NHS) outpatient appointment followed by nerve conduction~     studies. An equal number of healthy participants will be recruited for comparison purposes.~      At the aforementioned appointment, patients will undertake a pinch grip force test using a~     device that will test the above points.~      Patients will have normal care under their surgeon, which may include an operation for~     treatment of CTS. Therefore some patients will be invited back to have grip tests again after~     their operation. No aspect of the study will prevent a patient from receiving their normal~     National Health Service (NHS) care.~   "
56242|NCT02830815|"~     This will be a prospective, blinded, cross-over study to compare the effects of two~     anesthetic techniques on the interpretability of auditory brainstem response testing in~     children.~   "
56243|NCT02830802|"~     The investigators aim to evaluate a sage-based mouthrinse (Dr. Hauschka Med, Mundspülung~     Salbei) whether it is less or equal effective in alleviating inflammatory signs of intra-oral~     mucosa and gingiva than an water/alcohol-based taste adjusted placebo in patients dependent~     on ADL.~      Randomization in treatment A (mouthwash with active agent, n=24) or treatment B (placebo~     mouthwash, n=24) Supervised use of mouthwash A or mouthwash B over 6 weeks 1x/day additional~     to habitual oral hygiene protocol.~      The main outcome parameter will be Sulcus Bleeding Index SBI.~   "
56244|NCT02830789|"~     This study investigates whether calcium citrate or calcium carbonate are the optimal~     supplement to treat secondary hyperparathyroidism following Roux-en-Y gastric bypass~     operation.~      Half of the participants will be randomized to receive calcium citrate, while the other half~     will receive calcium carbonate. The study will be double blinded.~   "
62035|NCT02754882|"~     This study is designed to establish biosimilarity of SB8, a proposed biosimilar product of~     bevacizumab, to EU-sourced bevacizumab, in patients with metastatic or recurrent non-squamous~     non-small cell lung cancer (NSCLC).~   "
56245|NCT02830776|"~     Topical bimatoprost has been shown to cause periorbital changes of soft tissue which are most~     pronounced when used directly onto the cornea for the treatment of glaucoma. Changes are~     primarily felt to be the result of prostaglandin-mediated adipocyte loss, resulting in~     deepening of the upper eyelid sulcus and recession of infraorbital pseudoherniation. Use of~     topical bimatoprost to the upper eyelid margin, now FDA approved for eyelash enhancement, may~     provide a metered effect on the periocular tissues and allow for a topical approach to~     periocular rejuvenation.~      This is a proof of concept study which aims to enroll a series of patients with mild to~     severe dermatochalasis, treat with topical bimatoprost 0.03% solution to the upper lid~     margin, and evaluate for cosmetic improvement of the periocular area.~   "
56246|NCT02830763|"~     This study is planning to evaluate the safety and clinical efficacy of medium-chain fatty~     acid capsules (food-grade CNT-02) in subjects with primary triglyceride deposit~     cardiomyovasculopathy (TGCV) and neutral lipid storage disease with myopathy (NLSD-M)~     associated with adipose triglyceride lipase (ATGL) genetic defects.~   "
56247|NCT02830750|"~     Prospective data collection of patients undergoing Atrial Fibrillation Ablation.~   "
56248|NCT02830737|"~     Traditional RFA treatment has been a curable therapy for small hepatocellular carcinoma~     (diameter≤3cm). This technique ablates the tumor via radio frequency by inserting an~     electrode needle directly into the tumor. This clearly violates no-touch technique based on~     the principle of surgical oncology. Thus the 1-year recurrence rate of the cancer is up to~     30% after the treatment, and the 3-year tumor-free survival rate is only 20% - 40%. No-touch~     RFA treatment avoids the direct contact with the tumor that can cause the spread of cancer~     cells in the liver, or the Antrim spread, Therefore it has been suggested that no-touch RFA~     treatment reduce the recurrence rate after operation in comparison with the traditional RFA~     treatment. This research project aims at using the prospective randomized comparative method~     to compare the short-term and the long-term curative effects between no-touch RFA and~     traditional RFA treatments for small hepatic carcinoma.~   "
56249|NCT02830724|"~     Background:~      In a new cancer therapy, researchers take a person s blood, select a certain white blood cell~     to grow in the lab, and then change the genes of these cells using a virus. The cells are~     then given back to the person. This is called gene transfer. For this study, researchers will~     modify the person s white blood cells with anti-CD70.~      Objectives:~      To see if a gene transfer with anti-CD70 cells can safely shrink tumors and to be certain the~     treatment is safe.~      Eligibility:~      Adults age 18 and older diagnosed with cancer that has the CD70-expressing cancer.~      Design:~      Participants will be screened with medical history, physical exam, scans, and other tests.~     They may by admitted to the hospital. Leukapheresis will be performed. For this, blood is~     removed through a needle in the arm. A machine separates the white blood cells. The rest of~     the blood is returned through a needle in the other arm.~      Eligible participants will have an intravenous catheter placed in their upper chest. Over~     several days, they will get chemotherapy drugs and the anti-CD70 cells. They will recover in~     the hospital.~      Participants will take an antibiotic for 6 months after treatment. They will repeat~     leukapheresis.~      Participants will visit the clinic every 1-3 months for the first year after treatment, every~     6 months for the second year, and then as determined by their physician. Follow-up visits~     will take 1-2 days. At each visit, participants will have lab tests, imaging studies, and a~     physical exam.~      Throughout the study, blood will be taken and participants will have many tests to determine~     the size and extent of their tumor and the treatment s impact.~   "
56250|NCT02830711|"~     The mood was influenced by many factors in children. Sport, such as high-altitude mountain~     trek activity was thought benefit for human's mood and health. The expedition therapy was~     more and more popular in many schools recently. However, as the investigators best knowledge,~     there was no article discuss the relation between the mood and high-altitude mountain trek~     activity such as benefit influence in children. So, the investigators conduct the study.~      Method: Demographic data will be recorded. The Professor Yeh's mood questionnaires were used~     to record the mood status of before and after the 3 days high-altitude mountain trek~     activity.~      Statistical analyses: Participants rated their emotional states (happiness, sadness,~     anticipation, and anger) on a Likert scale. Each variable will be presented as descriptive~     statistics. Student t test or other suitable statistical method(s) will be used to determine~     the correction among the variables with scores of mood status. The paired t test or other~     suitable statistical method(s) will be used to determine the correction among the scores of~     mood status before and after the mountain activity. A difference was considered statistically~     significant if the p value were less than 0.05. All statistical analyses will be performed~     using SPPS statistical software for Windows, version 14 or more updated version.~   "
56251|NCT02830698|"~     The irritable bowel syndrome (IBS) is a very common disease in the pediatric population,~     where classical medical treatment does not always prove effective. This clinical entity has~     an impact on the individual physiological balance particularly on the autonomic regulation.~     Studies concerning adults with irritable bowel syndrome, showed significant changes in heart~     rate variability indices (HRV: heart rate variability).~      The study of time and frequency domain analysis of HRV allows noninvasive and reproducible~     assessment of the cardiac sympathetic and parasympathetic tone.~      The investigators hypothesize that the sympathovagal balance could be altered in children in~     case of prolonged nociceptive stress as the investigators find it in IBS. In recent years,~     the control of pediatric pain experienced considerable growth through hypnosis techniques and~     several studies have shown analgesic efficacy with a beneficial effect in terms of quality of~     life in children.~      Our study aims to assess the impact of the hypno-analgesia treatment of IBS on sympathovagal~     balance. The investigators propose to realize in 7 to 18 years old children with IBS a single~     center prospective study to highlight after a standardized hypnosis program, changes in the~     time and frequency domain indices of heart rate variability and clinical or quality of life~     parameters. The primary endpoint will be the high frequency HF indice. Secondary endpoints~     will be the other indices of HRV (Ptot, VLF, LF, ratio LF / HF, SDNN, SDANN, pNN50, RMSSD),~     the Quality of Life Questionnaire values (PedsQL ™ 4.0) a pain scale and the composite score~     of Francis.~   "
56281|NCT02830282|"~     This is a nested multicenter, prospective cohort study within the I-SPY 2 TRIAL for women~     undergoing neoadjuvant chemotherapy for primary breast cancer who are also undergoing~     definitive surgical resection and have clinical or radiographic evidence of residual tumor at~     the completion of chemotherapy.~   "
56252|NCT02830685|"~     The rationale for present trial conception and design moves forward from the assumption that~     a subcutaneous, pre-pectoral reconstruction by means of soft tissue replacement devices is~     feasible, safe and giving rewarding results when compared to the standard retro-pectoral~     technique. Ahead of that, the trial aims to test if there is a difference in the outcomes~     between a biological and a synthetic material when placed as a support under the mastectomy~     skin flaps, both in terms of immediate complications and of long-term results.~   "
56253|NCT02830672|"~     In this randomized, prospective clinical trial, patients with trigger finger or trigger~     thumb, will be treated with two different methods; ultrasound-guided release of the first~     annular pulley or open surgical release of A1 pulley. Results will be compared regarding~     functional, clinical and cosmetic outcome.~   "
56254|NCT02830659|"~     The purpose of this study is to determine the outcome of cochlear implant including post~     operative hearing ability, developing of language, complication from cochlear implant,~     quality of life, and success factor of cochlear implant.~   "
56255|NCT02830646|"~     Obesity promotes chronic kidney disease and is accelerating its shift to the stage of renal~     replacement. Bariatric surgery is a treatment for severe or morbid obesity whose renal~     benefit is currently unknown. The glomerular filtration rate (GFR) is the best parameter to~     define the kidney function. It can be estimated using formulas by assaying endogenous markers~     (creatinine, cystatin C) or measured with an exogenous tracer glomerular filtration (51~     Cr-EDTA).~      Bariatric surgery alters the production of endogenous markers and the extracellular volume~     (VEC) with 2 important consequences on the assessment of GFR: the formula to estimate GFR is~     not possible to compare renal function before and after surgery because of the variation in~     production of endogenous glomerular filtration markers in the same subject; decreasing VEC~     predicted decreased GFR after surgery, since these parameters are in part proportional to~     each other.~      Our working hypothesis is that bariatric surgery protects the kidneys of patients with~     chronic kidney disease. To demonstrate this, investigators propose to compare the ratio DFG /~     VEC before and after gastric bypass.~      Goals The main objective is to measure the effect of gastric bypass on the report DFG / VEC.~     Secondary objectives are to assess the effect of gastric bypass on the albumin / urine~     creatinine and evaluate the performance of the main GFR estimating formulas in people with~     severe or morbid obesity.~   "
56256|NCT02830633|"~     The purpose of this study is to determine: (1) whether laparoscopy-assisted nerve-preserved~     total mesorectal excision (LNTME) is as safe as open TME for rectal cancer, and (2) whether~     LNTME is more effective for protection of pelvic autonomic nerve function from surgical~     impairing when comparing to open TME.~   "
56257|NCT02830620|"~     The syndrome of anorexia-cachexie, which accompanies numerous cancers is a major comorbidity~     which compromises the forecast of these patients. Several cytokines pro-inflammatory as~     interleukines IL1 ß, IL6 or TNFa participate in the physiopathology of this syndrome at the~     man and the animal. Besides, it is now established that different neuronal populations,~     localized in the hypothalamus, are nerve centers of the control of the appetite and the~     energy homéostasie. However, there is not enough evidence of a direct action of cytokines on~     these neurones, suggesting the participation of intermediate molecules as chimiokines,~     inflammatory molecules produced in reaction to an immunological stress by gliales cells and~     acting directly on the surrounding neurones. The implication of chimiokines in the syndrome~     of anorexia-cachexie associated with the cancer thus seems very likely Among these,~     chimiokines  Monocyte Chemoattractant Proteins 1-3  or MCPs represent obvious candidates~     because they are produced by multiple tumors. Furthermore, to the mouse, the intellectual~     expression of MCP1 is correlated in the anorexia led by peripheral injections of a bacterial~     by-product, the lipopolysaccharide (LPS).~      The investigators' main objective is to test at the Man's, in situation of cancer of the~     pancreas any confused stages, the degree of prédictivité of the chimiokine MCP1 towards the~     syndrome of anorexia-cachexie associated with the cancer. The investigator also suggest~     describing: i) the link between rate plasmatique of MCP1 and energy metabolism on one hand,~     physical composition on the other hand;; ii) the impact of the other chimiokines,~     particularly those of the family of the MCPs, on the anorexia-cachexie bound to the cancer,~     iii) the correlation enters their profile of expression plasmatique and the severity of the~     anorexia, the energy metabolism and the physical composition; iv) the same research on the~     other inflammatory factors plasmatiques, of nature different from chimiokines; v) the~     correlation between thin mass and anorexia; vi) the evolution of the chimiokines various and~     inflammatory factors after surgical treatment or chemotherapy with curative aim in 6 months.~   "
56258|NCT02830607|"~     Low back pain (Lower Back Pain ) is extremely common , affecting more than 80 % of the~     general population in the modern world , one is considered the most common cause of~     disability in people under the age of 45. Lower back pain represents a social problem and~     substantial economies in Western countries , also considered a first cause for orthopedic~     consultation. In recent decades , a number of methods developed for assessing the functional~     status of patients with low back pain , and over twenty -five generic methods available today~     for use in pain clinics , orthopedic clinics and in clinical trials A large part of the~     measures used to monitor the response of patients to treatment of low back pain based on~     self-report questionnaires ,on patients' pain intensity , quality of life measures , and~     functional status In recent years a number of wearable monitoring devices designed to help~     people assess the progress of sports activity , by measuring steps , pulse , and quality of~     sleep , in this study we will use these measures to assess treatment efficacy after steroid~     injection to the epidural space in patients with low back pain . And compare the results to~     those taken from subjective self-report questionnaires .~   "
56259|NCT02830594|"~     This phase II trial studies how well pembrolizumab and palliative radiation therapy works in~     treating patients with esophagus, stomach, or gastroesophageal junction cancer that has~     spread to other parts of the body. Monoclonal antibodies, such as pembrolizumab, may~     interfere with the ability of tumor cells to grow and spread. Palliative radiation therapy,~     such as external beam radiation therapy, uses high energy beams to treat symptoms that are~     caused by tumors. Giving pembrolizumab together with palliative radiation therapy may work~     better in treating patients with esophagus, stomach, or gastroesophageal junction cancer that~     has spread to other parts of the body.~   "
56260|NCT02830568|"~     The main objective of this multicentre study is to conduct the evaluation of cost-efficiency~     of various techniques of kidney taking with regard the quality of life of the kidney living~     donors.~      It will allow to compare three techniques of taking (open donor nephrectomy, cœliosurgery~     pure or  hand-assisted  and cœliosurgery assisted by robot) and to determine their~     respective advantages in quality of life, then their medico-economic consequences in a~     cost-efficiency approach from the point of view of the society.~      The evaluation will concern the donor and the receiver followed three months after the~     taking.~      The open donor nephrectomy will be the technique of reference with which will be compared the~     two others.~   "
95278|NCT02320032|"~     This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of various doses~     and dosing intervals of aripiprazole lauroxil.~   "
56262|NCT02830529|"~     African Americans with prehypertension have a 35% greater risk of progressing to hypertension~     than whites. Dietary Approaches to Stop Hypertension (DASH) is a gold standard intervention~     for hypertension self-management. However, the barriers to self-management of hypertension~     reported by AAs include stress, including perceived stress related to racism/discrimination;~     perceived lack of control over getting hypertension in the future; limited social support;~     and low motivation to change behaviors. Activating the emotional and task areas of the brain~     are hypothesized to improve self-management behaviors. The purpose of this study is to test~     the effects of a promising new self-management intervention for AAs, a Mindfulness Attitude~     to Deliver the Dietary Approach to Stop Hypertension (MAD DASH) that departs from~     conventional interventions to address prehypertension by combining two self-management~     interventions (Mindfulness and DASH) in a group setting. Teaching mindfulness; a form of~     meditation and the DASH diet to participants is expected to result in a reduction in blood~     pressure as compared to usual care or DASH diet education alone.~   "
56263|NCT02830516|"~     Classically lung elastance and transpulmonary pressure are measured from the difference in~     tidal variations of airway pressure subtracted by tidal variations i esophagus pressure~     divided by the tidal volume. This requires the presence of a esophageal balloon catheter~     which is cumbersome and costly. In this study values obtained as described above are compared~     to values obtained with a new method in which a stepwise increase in positive endexpiratory~     pressure (PEEP) is performed with a size which corresponds to the tidal volume which the~     patient is ventilated with. These measurements are performed in anesthetized patients prior~     to major surgery.~   "
56264|NCT02830503|"~     Project summary~      Rationale~      Many NICU's replace their feeding tubes once a week or more rarely in order to avoid~     disturbing the infants. The researchers discovered that there are high concentrations of~     potentially pathogenic bacteria in the yield of resident nasogastric feeding tubes, even~     within one day of use (own data, manuscript submitted). Preterm infants are vulnerable to the~     colonization of the gut, and development of dysbiosis might lead to necrotizing~     enterocolitis. The researchers speculate if replacing the resident feeding tube every day and~     thereby decreasing the amount of potentially pathogenic bacteria given to the infants via the~     feeding tube will lead to fewer bacteria present in the upper part of the gastrointestinal~     tract of the infant and hence a reduced competition with probiotic colonization.~      Objectives~      The investigators plan to conduct an intervention study in premature infants receiving~     probiotics (< 32 weeks of gestation) where the feeding tube will be replaced every day in the~     intervention group and once a week (standard practice) in the control group. The main outcome~     will be bacterial concentration in the stomach after one week of life.~      Methods~      The study is a prospective, randomized controlled trial in preterm infants. Infants will be~     randomized to the intervention group in which the tube is replaced every day or the control~     group which will follow normal practice in the department. The intervention will last one~     week. The infants will be followed until discharge. The investigators plan to include 11~     infants in each group.~      Primary outcome~      Concentration of bacteria in gastric aspirates on day seven.~   "
56265|NCT02830490|"~     The investigators pretend to calculate values absolute and relative reliability that have not~     been yet reported (Short Physical Performance Battery, one-leg balance and Timed Up and go).~   "
56266|NCT02830477|"~     The primary objective of this study is to investigate weekly prophylaxis dosing regimens used~     in standard clinical practice.~      In addition the study will capture reported bleed rate, pattern of change in KOVALTRY~     prophylaxis dose & dosing frequency, reason for choice of treatment regimen, FVIII product~     switch pattern, patient treatment satisfaction and adherence, KOVALTRY pharmacokinetic data~     (if performed), KOVALTRY consumption, as well as safety data.~   "
56267|NCT02830464|"~     In this study, prognostically relevant biomarkers for cardiovascular / renal insufficiencies~     will be clinically evaluated, to improve the course of assessment of such disease and to gain~     new insights into the typical course of congestive heart failure. This is a prerequisite to~     allow patients to appropriate treatment as soon as possible.~   "
56268|NCT02830451|"~     The registry aims to collect patient information such as patient demographics,~     co-morbidities, clinical, diagnostic, and therapeutic data, as well as information on adverse~     events and HRQOL outcomes specific for patients with metastatic spine tumor(s).~   "
56269|NCT02830438|"~     In this proposal, the aim is to examine shear wave elastography (SWE) measurements in~     diseased native kidneys and correlate them with grades of fibrosis using histological~     samples.~      The overall goals of the proposed study are addressed by the following specific aim.~      Specific aim: To determine whether differences exist in elasticity measurements between~     native kidneys with and without fibrosis.~      Hypothesis: Kidneys with higher grades of fibrosis will demonstrate higher measures of tissue~     elasticity and stiffness compared to kidneys with zero fibrosis.~   "
56270|NCT02830425|"~     A prospective multicenter cohort study in 5 hospitals in Spain will be initiated in 2016.~      Objectives:~        1. To estimate and describe patterns of multimorbidity and polypharmacy in patients over 64~          admitted for a chronic disease exacerbation.~        2. To analyze the potentially inappropriate prescribing (PPI) drugs according to STOPP /~          START (SS) criteria.~        3. To evaluate the relationship between multimorbidity and PPI and adverse medication (RAM)~          preventable reaction.~      The cohort will include 800 patients >64 years admitted in internal medicine and / or~     geriatric department of 5 hospitals of the National Health Service. Application of the SS~     criteria (released in 2015) on admission and at discharge, and collection of demographic and~     clinical variables including comorbidities, baseline chronic medication, geriatric syndromes,~     functional capacity and RAM. Descriptive analysis and bivariate parametric or nonparametric~     tests will be applied to analyze relationship between morbidity, polypharmacy, SS criteria~     and RAM. Intraobserver agreement will be assessed for SS criteria. Multiple regression~     techniques will be applied, where the dependent variable will be the PPI or the RAM.~   "
56292|NCT02830139|"~     The efficacy of HIPEC in prevention of local recurrence, distant metastasis or peritoneal~     metastasis in locally advanced colorectal cancer is not definite. The hypothesis of the trial~     is that radical colorectal resection plus HIPEC is superior to only radical colorectal~     resection in terms of overall survival.~   "
62092|NCT02754141|"~     The purpose of this study is to assess the safety and tumor-shrinking ability of experimental~     medication BMS-986179 alone and when combined with Nivolumab, in patients with solid cancers~     that are advanced or have spread.~   "
56271|NCT02830412|"~     This project intends to develop and implement an electronic reminder for post-operative~     nausea and vomiting (PONV) prophylaxis into the Anesthesia Record Keeping System.~      Each patient will have his or her PONV risk classified based on the following risk factors:~     Female gender, History of PONV, History of Motion Sickness, Non-smoker and Duration of~     procedure > 60 minutes.~      Patients will be randomized to either receive the PONV reminder or not. Those receiving the~     PONV reminder will have the PONV risk assessment and current guideline information for PONV~     prophylaxis displayed on the Anesthesia Record Keeping System (ARKS) screen at the beginning~     of the case.~      At the end of the procedure (specific at documentation of emergence), the reminder will~     assess the current status of PONV prophylaxis as per anti-emetic medications administered and~     compare the current status to the recommended status based on published guidelines.~      If the current status is compatible or exceeds the recommended status the reminder will~     silently document compliance.~      If published guidelines suggest additional PONV prophylaxis based on the patients risk~     profile and a comparison with the currently documented status, an electronic reminder will~     appear on the ARKS screen to alert the anesthesia provider of an opportunity to enhance~     guideline adherence.~      The reminder will not recommend a specific medication, intervention or therapy.~      It will be completely the decision of the anesthesia provider if and how to modify the PONV~     prophylaxis for the patient.~      Subjects randomized to not receive the electronic display will have it deactivated.~   "
56272|NCT02830399|"~     It's a prospective, multicentric, randomized, controlled study concerning 84 patients with~     treatment-resistant depression (TRD). The aim of the study is to evaluate the augmentation of~     Electroconvulsive therapy (ECT) by repeated Transcranial Magnetic Stimulation (rTMS). The~     primary outcome will be the depressive symptoms intensity measured with the Hamilton Rating~     Scale For Depression (HAMD-21 items) after 5 ECT. The secondary outcome is to evaluate the~     safety and most particularly the cognitive effects of this association.~   "
56273|NCT02830386|"~     This study aims to investigating the efficacy and safety of low profile visualized~     intraluminal support (LVIS) stents for the treatment of ruptured intracranial saccular~     aneurysms. The follow-up duration is 1 year.~   "
56274|NCT02830373|"~     This study aims to investigating the efficacy and safety of low profile visualized~     intraluminal support (LVIS) stents for the treatment of unruptured intracranial saccular~     aneurysms.~   "
56275|NCT02830360|"~     A multicenter, randomized clinical trial to assess whether catheter ablation or~     antiarrhythmic drug therapy provides the most effective control of important clinical~     outcomes for patients with prior myocardial infarction and sustained monomorphic ventricular~     tachycardia (VT).~   "
56276|NCT02830347|"~     The aim of this study is to evaluate the nature of the change in oral and gut bacterial~     resistance profiles after antibiotic therapy for a surgical procedure in two groups. The~     intervention group will receive a course of amoxicillin and analgesics after surgical~     extraction and have bacterial samples taken from saliva, tongue coatings and stool samples at~     four appointments over a period of six months. This will be compared to the control group~     which receive only analgesics after the surgical extraction.~      An examination of the development and sustainability of antibiotic resistance in the oral and~     gut microbiome of healthy cohorts will be followed up for 6 months, after surgical extraction~     of impacted teeth.~      Change in proportion of antibiotic resistant bacterial components will be studied using~     Metagenomic DNA sequencing and quantification of resistant genes .~   "
56277|NCT02830334|"~     Background:~      Doctors and nurses who work in non-mental health settings need ways to know when patients are~     at risk. Researchers created the Ask Suicide-Screening Questions (ASQ) to be used in an~     emergency department for children. This is a 4-item suicide risk screening tool. We wanted to~     see if this is also a good tool to use in the outpatient setting. Two studies are being done~     to test it at hospitals. This study is for researchers to analyze the data from those two~     studies.~      Objectives:~      To combine and analyze data from two studies to see how well the ASQ can detect suicide risk~     in pediatric outpatient clinics.~      Eligibility:~      No people are enrolled in this study.~      Design:~      Participants in the two non-NIH studies will give consent for their data to be shared.~      The data will be confidential and secure. They will have no personal information attached to~     them.~      Researchers will get the data and analyze them.~   "
56278|NCT02830321|"~     The purpose of this study to explore the association between Hyperemesis Gravidarum in~     pregnant women and Helicobacter pylori infection.~   "
56279|NCT02830308|"~     Background:~      There are many endocrine and metabolic-related conditions. Two well-known disorders include~     diabetes and thyroid disease. Some of these diseases are caused by a change in genes.~     Researchers want to identify the genes involved in these disorders. They hope this will help~     them learn more about these diseases.~      Objectives:~      To learn more about conditions that affect the hormone-secreting glands (endocrine glands) in~     adults. To train doctors to diagnose and treat people with endocrine or metabolic conditions.~      Eligibility:~      Adults age 18 years and older with a known or suspected endocrine disorder.~      Relatives ages 18 years and older.~      Doctors will review all requests and available medical records to determine final eligibility~     for the protocol.~      Design:~      Participants will have a medical history and physical exam.~      Most participants will have 1 visit, and may have follow up visits if necessary. They may~     have tests, surgery, or other procedures to help diagnose or treat their condition. These~     could include:~        -  Blood, urine, and saliva tests~        -  Imaging tests. These may include X-ray, ultrasound, or scans.~        -  Sleep study~        -  Medical photographs~        -  Visits with other specialists at NIH~      Participants will provide blood, urine, saliva, or tissue samples. Some of these samples may~     be stored in the freezer for future studies.~      Participants may be asked to participate in genetic testing. They will give a blood or saliva~     sample for this.~   "
56280|NCT02830295|"~     A randomized trial of Basic Body Awareness Therapy (BBAT) is applied in fibromyalgia patients~     as compared with a control intervention consisting of treatment as an usual. Sessions of BBAT~     lasted 90 minutes each and took place twice a week for 5 weeks. The primary end point is a~     change in the Visual Analog Scale score and Body Awareness Rating Scale and the secondary end~     points include Hospital Anxiety Depression, State Trait Anxiety Inventory, Beck Depression~     Inventory and Short Form 36. All assessments will be repeated at post treatment, 12 weeks and~     24 weeks~   "
56282|NCT02830269|"~     Transcranial Doppler ultrasonography is usually used in the evaluation and management of~     patients with brain injury. This noninvasive method measures local blood flow velocity and~     direction in the proximal portions of large intracranial arteries. The operator requires a~     short training and experience to perform. The third ventricle diameter measurement by~     transcranial duplex flow sonography was performed in healthy volunteers . This studies show~     similar results in those obtained with the MRI or Computer Tomography (CT). Currently the~     third ventricle diameter measurements by transcranial Doppler ultrasonography was not~     validated for neuro-intensive care unit patients. The investigators propose to used recent~     ultrasound system to validate the third ventricle diameter measurements in comparison with~     the standard method (CT).~   "
56283|NCT02830256|"~     Nociception in intensive care unit is frequently evaluated with some tools such as BPS~     (Behavioral Pain scale) and NCS (Nociception coma scale). These scales were not validated in~     intubated and brain injured ICU patients. The investigators propose to validate the NCS~     adapted for intubated patients (NCS-I) in comparison with the recommended scale (BPS) and the~     Pupillary response (videopupillometry) to noxious stimulation (common procedure of care).~   "
56284|NCT02830243|"~     The purpose of this clinical trial is to compare analgesic effect of sevoflurane and~     desflurane at equal minimum alveolar concentrations using surgical pleth index.~   "
56285|NCT02830230|"~     There is a strong causal association between persisting genital tract infection with Human~     Papilloma Virus (HPV) and gradual progression of infection to cervical (mouth of uterus)~     cancer.The robust study from India have shown that single round of HPV DNA screening test to~     significantly reduce the cervical cancer mortality. The above findings are very encouraging~     since it demonstrates that a simple and reliable HPV DNA test which is now available in low~     income countries has a potential to be accepted as primary screening test in future.~      The cross-sectional studies from developed countries from year 1999-2004 which focused to~     determine the test characteristics of HPV Hybrid Capture 2 test (HC2) to determine CIN2 and~     higher grade lesions, reported test sensitivity of 90% to 100% with a mean of 95%.~      Similarly the cross-sectional studies from developing countries from 1993 to 2003 which have~     focused on test characteristics of HPV DNA Hybrid capture 2 (HC2) test to determine CIN2 and~     higher grade lesions has shown a sensitivity in the range of 50% to 91% with an average~     sensitivity of 79%.Among the developing countries cross-sectional study from India which~     evaluated test reported sensitivity of only 68.2%.~      There is a statistical significant difference ( p value = 0.003) of sensitivity of HPV DNA~     HC2 test between the developed and developing countries to determine CIN2+ Lesions while~     there is no difference in the specificity.~      A study that was conducted in Chinese women to detected the prevalence of HPV genotype among~     women with mucopurulent cervicitis, healthy women and women with Invasive cancer, the author~     reported a 10% higher failure rates to extract HPV DNA in cases of mucopurulent cervicitis as~     compared to other two groups.~      So the study will explore if if the presence of untreated co-infections with STIs/RTIs~     (Sexually transmitted infections/Reproductive tract infections) resulting in cervical~     inflammation is somewhere interfering with low sensitivity of HC2 test due to presence of~     blood and excess mucus associated with the conditions leading to low sensitivity of the test~     in context to Indian Scenario.~   "
56286|NCT02830217|"~     ST-elevation myocardial infarction (STEMI) is an urgent symptom associated with sudden~     myocardial ischemia and ST segment elevated in ECG. Primary percutaneous coronary~     intervention (PCI) re-open infarct artery efficiently for STEMI patients. However, patients~     are readmitted shortly after the primary PCI for several unfavorable clinical outcomes~     including thrombosis in stent, recurrence of myocardial infarction, stroke, and heart~     failure. This study is intended to test the predictive ability of a new biomarker soluble ST2~     (sST2) in peripheral blood. Previous studies have shown that elevated sST2 is highly~     associated with unfavorable clinical outcomes of patients with ischemia heart diseases and~     heart failure. This study will further investigate the ability of sST2 to predict unfavorable~     outcomes for STEMI patients after primary PCI.~   "
56287|NCT02830204|"~     The purpose of this study is to establish the safety and feasibility of the Edwards SAPIEN 3~     valve in subjects with mitral annular calcification (MAC) associated with mitral stenosis~     (MS) and/or mitral regurgitation who are at high-risk for mitral valve surgery or deemed~     inoperable due to the extent of calcification.~   "
56288|NCT02830191|"~     Ciclosporin A (CsA) is an immunosuppressive drug used in organs and tissues transplantations~     (kidney, heart, liver, bone marrow ...) to prevent rejection, and in different autoimmune or~     inflammatory diseases. A therapeutic drug monitoring (TDM) is required during a CsA~     treatment. It is justified by a narrow therapeutic range between efficiency and~     nephrotoxicity, and by large intra- and interindividual pharmacokinetic variability. TDM of~     CsA is conventionally performed by determining residual concentration, and sometimes~     concentration at 2 hours after administration. TDM of CsA is currently performed by venous~     sampling on ethylenediaminetetraacetic acid (EDTA). Dried blood spot (DBS) sampling could be~     a particularly interesting alternative to conventional blood sampling. With DBS, capillary~     blood is obtained from a finger prick by the patient himself, and the blood drop obtained is~     deposited on filter paper, which can be stored at room temperature and then be sent to the~     laboratory by mail.~      This sampling method has several advantages : it requires small blood volumes, it is less~     invasive than conventional venous sampling, sampling can be performed by the patient himself~     at home few days before the consultation, and the results of the analysis can be available to~     the clinician on the day of consultation, allowing dose adjustment more quickly.~      Several studies have been published in recent years using DBS sampling method, for various~     drugs such as antimalarials, antiepileptics, antiretrovirals, metformin, benzodiazepines, or~     immunosuppressants. Only one clinical validation study of TDM of CsA using DBS method was~     published by Wilhelm et al. (2013) in a population of 38 patients who received allogeneic~     stem cell transplant recipients. The results showed excellent correlation between the~     concentrations determined by the two sampling methods.~      The investigators propose an observational study at the University Hospital of Caen for~     clinical validation of DBS sampling for TDM of CsA in kidney transplantation, for which there~     are no data published. During a nephrology consultation, for each patient, venous and finger~     prick blood samples are simultaneously collected. CsA assays were performed by liquid~     chromatography-tandem mass spectrometry (LC-MS/MS) for the two sampling methods. A specific~     LC-MS/MS assay method applied for DBS samples was developed and validated for this study~     (DBS/LC-MS/MS). Correlation between the results obtained from the two sampling methods will~     be evaluated, on at least 100 samples. Patients have to answer a questionnaire to assess pain~     and comfort of DBS sampling, and feasibility of self-sampling at home by this method. The aim~     of this clinical validation study of DBS sampling is the establishment of the systematic TDM~     of CsA for renal transplant patients by DBS sampling at the University Hospital of Caen.~   "
56289|NCT02830178|"~     The Purpose of this study is to examine whether evidence of channeling exists by analyzing~     within a cohort of participants with first prescriptions of single-ingredient paracetamol or~     ibuprofen (or both) whether participants with paracetamol were more likely to have an~     ibuprofen-related contraindication.~   "
56290|NCT02830165|"~     This phase I trial studies stereotactic body radiation therapy (SBRT) in treating patients~     with prostate cancer that is likely to come back or spread (high-risk) undergoing surgery.~     SBRT is a type of external radiation therapy that uses special equipment to position a~     patient and precisely deliver radiation to tumors in the body. Delivering radiotherapy before~     prostatectomy by SBRT is more convenient, conformal, and may spare normal tissues better than~     delivering radiotherapy after prostatectomy.~   "
56291|NCT02830152|"~     Intracerebral hemorrhage (ICH) in patients with non-valvular atrial fibrillation (NVAF) poses~     a particular dilemma for thromboprophylaxis. Left atrial appendage occlusion (LAAO) is a~     non-pharmacological approach to prevent cardiac embolism in NVAF. The risk-benefit ratio of~     LAAO in patients with NVAF after ICH is unknown. The aim of STROKECLOSE is to assess the~     effect of LAAO to reduce the incidence stroke, bleeding and cardiovascular mortality in~     patients with NVAF and prior ICH.~   "
56293|NCT02830126|"~     This study is a pragmatic, comparative effectiveness trial that will randomize approximately~     12,000 adult surgical patients on an operating room (OR) level to a control or to an~     intervention group. All OR clinicians will have access to decision support software within~     the OR as a part of enhanced standard intraoperative care. The ACT will monitor patients in~     both groups and will provide additional support to the clinicians assigned to intervention~     ORs.~   "
56294|NCT02830113|"~     This study was aimed at assessing the effects of non-surgical periodontal treatment (NSPT) of~     chronic periodontitis on insulin sensitivity, glucose tolerance, and serum C-reactive~     protein(CRP) level amongst non-diabetic subjects.~   "
56295|NCT02830100|"~     The goal is to define what is the nature of intern speech, how it manifests itself, who deal~     with agency in intern speech and finally what is the role of intern speech in attention~     tasks.~   "
56296|NCT02830087|"~     This proposed novel randomized control trial (RCT) seeks to address this gap in TKA protocol~     by gaining a better understanding of the relationship between tourniquet pressure and time,~     and intraoperative performance and post-operative outcomes. This study does not seek to~     answer the question of tourniquet vs no tourniquet, but to seek a tourniquet usage that~     would maximize the intraoperative benefits for the surgeon and minimize the negative~     consequences for patient outcomes.~      Specific Aim #1: enroll around 146 primary TKA patients.~      Specific Aim #2: evaluate different tourniquet cuff pressures (TCP) and tourniquet times in~     relation to intraoperative performance.~      Specific Aim #3: evaluate different TCP and tourniquet times in relation to post-operative~     pain and complications of short-term, intermediate, and long-term followup.~      Specific Aim #4: evaluate different TCP and tourniquet times in relation to post-operative~     function of short-term, intermediate, and long-term followup.~   "
56297|NCT02830074|"~     Sleep-disordered breathing (SDB) remains under-treated in individuals living with spinal cord~     injuries and disorders (SCI/D). The investigators' aim is to test a program that addresses~     challenges and barriers to positive airway pressure (PAP) treatment of SDB among patients~     with SCI/D. The investigators anticipate that patients who receive this program will have~     higher rates of PAP use and will demonstrate improvements in sleep quality, general~     functioning, respiratory functioning and quality of life from baseline to 6 months follow up~     compared to individuals who receive a control program. This work addresses critical~     healthcare needs for patients with SCI/D and may lead to improved health and quality of life~     for these patients.~   "
56298|NCT02830061|"~     This study looks at the experiences of teenagers and young adults who have been offered~     ovarian tissue cryopreservation prior to cancer treatment as a result of their cancer and/or~     cancer treatment putting them at moderate-to-high risk of premature ovarian failure.~   "
56299|NCT02830048|"~     Diabetes is a chronic condition that affects 1 in 16 people in the UK, and leads to~     difficulty controlling blood sugar levels. This is due to an imbalance between two main~     hormones: insulin, which lowers blood sugar, and glucagon, which causes it to rise. Most~     current anti-diabetic medications work to improve insulin levels, however research is now~     shifting to better understand how glucagon levels play a key role in this disease.~      Glibenclamide is a type of anti-diabetic medication (sulfonylurea) which is commonly used to~     increase the amount of insulin released by the pancreatic beta-cells. Studies in mice and~     human cells from donors with type 2 diabetes have shown that sulfonylureas can also improve~     glucagon levels when used in very small doses by working on different cells in the pancreas~     (alpha-cells).~      The aim of this study is to find out whether low doses of glibenclamide can improve glucagon~     levels in patients with type 2 diabetes, and whether in the future this could be used to~     better control high blood sugar levels, without the risk of causing low blood sugar.~      Participants with type 2 diabetes who are diet-controlled or on metformin will be given a~     liquid containing a low dose of glibenclamide. They will need to attend the OCDEM Clinical~     Research Unit at the Churchill Hospital, Oxford, for early morning blood tests every 3-4 days~     over a period of 3 weeks. A continuous glucose monitor will also be fitted during this time.~      This study is funded by the NIHR OxBRC.~   "
56300|NCT02830035|"~     The purpose of this study is to compare the clinical efficacy of real-time ultrasound~     guidance on spinal anesthesia vs the traditional anatomical landmark technique, by comparing~     success rate of spinal needle insertion, success rate rate of single needle pass, duration~     and immediate complications.~   "
56301|NCT02830022|"~     Autism Spectrum Disorders (ASD) is a neurodevelopmental disorder which involves social and~     behavioural impairments. Autonomic dysfunctions and disturbed sleep were often associated to~     ASD. The investigators proposed to explore the impact of physical activity on these~     disorders. In this context, it is necessary to characterize the cardiorespiratory capacities~     of ASD children in order to promote physical activity for this population. To examine~     potential differences between ASD and control children, some explorations were proposed: a~     maximal treadmill test, motor evaluation, and orthostatic test (for the evaluation of~     autonomic nervous system).~      An actimetry during one week (evaluation of physical activity and sleep) completed this study~     in order to specify sleep characteristic and established the possible link between physical~     activity sleep characteristics and physical fitness in ASD children.~   "
56302|NCT02830009|"~     The aim of this study is to know the difference between protein profiles (multi-analyte~     profile) of PH1 patients, idiopathic hypercalciuria (IH) patients and PH1 patients 'siblings.~     Idiopathic hypercalciuria is a less severe kidney disease that PH1, which also leads to the~     formation of kidney stones.~      The aim is to identify patterns of discriminating markers associated with primary~     hyperoxaluria type 1 (PH1) that will significantly improve clinical diagnosis and prognosis.~   "
56322|NCT02829749|"~     The main objective is to assess the effectiveness and safety of the NeoChord DS1000 repair~     technique as compared with conventional open-heart on-pump mitral valve surgery in patients~     with severe primary mitral regurgitation.~   "
56323|NCT02829736|"~     Chest tubes are used routinely although preliminary studies demonstrate the feasibility and~     safety of intraoperative chest drain removal. Previous studies are however either~     retrospective or mainly concerning benign disease.~      Hypothesis: Participants treated without post-operative chest tube after thoracoscopic wedge~     resection have less pain, better pulmonary function and similar complication profile than~     participants treated with standard post-operative chest tube, and could possibly be~     discharged earlier.~   "
56303|NCT02829996|"~     Phase II, randomized, double-masked study to evaluate the efficacy and tolerability of~     topical ocular delivery of fixed-dosed combinations of trabodenoson and latanoprost in~     subjects with Ocular Hypertension or Primary Open-Angle Glaucoma.~      All subjects who meet the study's enrollment criteria following Screening will undergo~     washout of all prohibited medications (if washout is needed), including their routine~     glaucoma medications. During the Placebo Run-In Period, placebo is applied twice daily to~     both eyes in all subjects. During the Treatment Period, study drug is applied to both eyes~     for a total of 8 weeks. Each subject will be assigned 4 weeks of AM and 4 weeks of PM dosing~     in a masked manner. AM vs PM dosing is masked utilizing Placebo in addition to the active~     drug product. During the Treatment Period, study drug (Active and Placebo) eye drop~     applications will occur twice daily, in the morning and in the evening. The Treatment Period~     will be followed by an Observation Period of approximately 7 days wherein no study eye drops~     are instilled.~      The purpose of the study is to assess the overall benefit/risk profile of binocular topical~     application of different doses of trabodenoson (3.0% and 6.0%) when combined with latanoprost~     (0.005% or 0.0025%) one drop daily (QD) for 8 weeks.~   "
56304|NCT02829983|"~     To assess the periodontal clinical response and the possible adverse effects of the~     clarithromycin combined to periodontal mechanical therapy in the treatment of patients with~     generalized aggressive periodontitis.~   "
56305|NCT02829970|"~     There are currently no published randomized controlled studies examining psychosocial~     interventions for college students with ADHD, and none specifically targeting AUDs in this~     population at any age, despite the clear indication from emerging research of the need for~     such interventions. In the current study, the investigators will develop BA-based treatment~     intended to increase involvement in healthy, goal-directed activities (e.g., academic,~     recreational or social activities) and to reduce problematic drinking behaviors and other~     risk behaviors (e.g., unsafe sex) among college students with ADHD (Behavioral Activation for~     Attention & Alcohol Disorders; BAAAD). Finalized treatment manuals, altered based on focus~     group feedback, will be tested in a stage I randomized controlled trial (RCT) among 80~     college students randomized to BMI + BAAAD or BMI + supportive counseling (SC). The~     investigators expect that BMI + BAAAD will be successful with college students with ADHD, in~     terms of decreasing the escalation of problematic alcohol use behaviors, as compared to BMI +~     SC. This treatment development study will set the stage for larger-scale RCTs.~   "
56306|NCT02829957|"~     A large proportion of women with menstruating potential with newly diagnosed VTE or atrial~     fibrillation, treated with apixaban will have less menstrual blood loss than patients~     randomized to rivaroxaban.~   "
56307|NCT02829944|"~     The purpose of this study is to determine if the infusion of the local anesthetic ropivacaine~     (a numbing medicine) and the non-steroidal anti-inflammatory drug ketorolac (a pain killer~     similar to ibuprofen) through a catheter placed along the cesarean delivery incision, will~     reduce the pain experienced after cesarean section and need for narcotic pain medicine.~   "
56308|NCT02829931|"~     The main purpose of this study is to evaluate the safety and tolerability of nivolumab, given~     in combination with hypofractionated stereotactic re-irradiation of recurrent high grade~     gliomas.~   "
56309|NCT02829918|"~     This research study is designed to see if a drug called Nivolumab is effective in treating~     patients with advanced refractory biliary tract cancers. Nivolumab has been approved by the~     U.S. Food and Drug Administration (FDA) for treatment of certain types of cancer but is not~     approved by the FDA for treatment of your type of cancer.~   "
56310|NCT02829905|"~     Study will develop, validate and pilot measures to assess quality of experiences of~     mammography. Pilot data collection and analysis will investigate modifiable factors most~     important in determining quality of patient experiences of mammography.~   "
56311|NCT02829892|"~     Alzheimer's disease and related syndromes (AD) is a disease affecting memory but also the~     relationship with the environment and empower people. Patients with AD present in 90% of~     cases of behavioral disorders and of these behavioral disorders include agitation, apathy but~     also sleep disorders by circadian rhythm impairment.. No study has shown proven efficacy on~     the behavior of patients with AD. The main objective of the study was to assess the influence~     of environmental light nighttime sleep of residents.~   "
56312|NCT02829879|"~     Introduction: Dentin hypersensitivity (DH) could be defined as a brief and sharp pain in~     response to thermical, chemical, tactile and osmotic stimuli, which cannot be attributed to~     any dental condition or pathology. Multiple therapies for the treatment of DH have been~     studied, including equivocal evidence about the efficacy of potassium nitrate salts and~     recent investigations a promising new 8% Arginin dentifrice.~      Aim: The aim of this study is to compare the clinical effectiveness of 8% arginine/1450ppm~     sodium monofluorophosphate (D1) and 5% potassium nitrate/2500ppm sodium fluoride (D2)~     dentifrices in the treatment of dentin hypersensitivity.~      Methods: Parallel-design, double-masked, randomized controlled clinical trial. Fifty healthy~     volunteers aged 18 to 70 years who attend at the Faculty of Dentistry , University of Chile,~     with DH and a visual analog scale (VAS) score ≥4 at least in two anterior and/or premolar~     teeth, will be selected and randomized into two treatment groups: T1 (n=25): 8% arginine/1450~     ppm sodium monofluorophosphate dentifrice (D1); and T2 (n=25): 5% potassium nitrate/2500 ppm~     sodium fluoride dentifrice (D2). Environmental, dietary and oral hygiene habits will be~     recorded in a clinical chart, while O´Leary plaque index and dentin hypersensitivity (DH)~     measurements will be clinically assessed, at baseline, 4 and 8 weeks. DH will be evaluated~     through the mean VAS value in response to evaporative and thermal stimuli at baseline, 4 and~     8 week follow-up. The data will be analysed through Stata® V11 program.~   "
56324|NCT02829723|"~     The purpose of this first-in-human (FIH) study of BLZ945 given as a single agent or in~     combination with PDR001 is to characterize the safety, tolerability, pharmacokinetics (PK),~     pharmacodynamics, and anti-tumor activity of BLZ945, administered orally, as a single agent~     or in combination with PDR001, administered intravenously (i.v.) in adult patients with~     advanced solid tumors.~      Dose escalation will be guided by a Bayesian logistic regression model with overdose control.~     Once MTD/ RP2D is declared, patients will be enrolled in the phase II part in the selected~     indications (glioblastoma, pancreatic cancer and triple negative breast cancer) to further~     assess the preliminary anti-tumor activity of BLZ945 in combination with PDR001. Should signs~     of anti-tumor activity be seen in the phase I dose escalation with BLZ945 as single agent, a~     phase II part will be opened in order to further explore BLZ945 single agent efficacy at the~     recommended dose.~   "
56313|NCT02829866|"~     Total hip replacement (THP) is widely used for hip osteoarthritis treatment. Surgeons are~     constantly looking to improve all aspects related to this procedure weather is improvement of~     implant design, instrumentation or surgical technique. Excellent clinical and radiological~     results were observed at medium and long term in the last years for AMIStem system.~      This observational study has the objective to survey hip prosthesis stability and function of~     the operated hip in patients who are not exposed to surgical risks. The principal~     investigator will contact all patients in order to perform the follow-up visit according to~     standard practice. Patients operated between January 2010 and December 2011 will be invited~     in the study during the clinical visit organised according to standard practice. Preoperative~     clinical and radiological data, intraoperative details and postoperative follow-up data at~     1-year will be retrospectively collected. Five-year data will be prospectively collected~     after inclusion in the study.~   "
56314|NCT02829853|"~     Major impacts of air pollution are lung diseases such as granulomatous diseases and mainly~     sarcoidosis. Understanding the respective role of inorganic / nanoparticles and genetic~     background in these chronic diseases is a major challenge for the management of patients and~     prevention strategies. Granulomas are characterized by giant epithelioid and multinucleated~     cells, reflecting a severe disturbance in immunological pathways induced both by toxic~     exposure and genetic predisposition. Previous studies demonstrated that professional~     environmental context and acute exposures (the World Trade Center disaster) to~     micro/nanoparticles have a pathogenic impact with a sharp increase in sarcoidosis.~     Sarcoidosis is a multifactorial disease occurring in a genetically vulnerable context. Many~     gene variants have been linked to an increased odds-ratio of the disease, such BTNL2,~     CCDC88B, ANNEXIN A11 involved in regulation of T-cell activation and maturation pathways. We~     have contributed since 2008 to a national cohort (GSF, 28 centers) of ≈ 800 sarcoidosis~     patients with familial and sporadic presentation of the disease. This collection has been an~     exceptional (and worldwide unique) tool for the implementation of an exhaustive clinical~     database on sarcoidosis, modelling of disease evolution and identification of clinical /~     genetic criteria differentiating sporadic and familial forms.~      The main goals of the project are:~        1. Completion of the genetic data in order to establish a pattern of gene variants~          segregating with familial forms of the disease, compared to sporadic one. This will be~          done by WES (WHOLE EXOME) analysis on the previously collected DNA samples. The informed~          consent for the patients included the information about the BTNL2 gene, which has been~          already tested since 2008, and related genes connected to immune pathways, thus allowing~          a unambiguous information about the research finality of the project.~        2. Completion of the clinical data about each patient, in cooperation with the GSF network,~          management of the database established since 2008. The data collected are those which~          are commonly detailed in the normal follow-up of the patients. The project do not~          include any new interventions on the patient (neither radiological or invasive tests).~        3. Specific biological studies might be done on the white blood cells of the patients, and~          might need in such cases a new blood sampling, both in patients and first degree related~          healthy controls. Theses specific studies will be presented to an ethical committee~          (CCP) in order to validate the feasibility in term of 'new intervention' on the cohort.~          The samples collected will be at the same volume of a classical blood sampling (2*7 ml).~        4. Any other projects, submitted to the GSF network will needed a specific registration and~          ethical committee validation.~   "
56315|NCT02829840|"~     The goal of Part 1 of this clinical research study is to learn if ponatinib alone can help to~     control FLT3-mutated AML or FLT3-mutated high-risk MDS. The safety of this drug will also be~     studied.~      The goal of Part 2 of this clinical research study is to find the highest tolerable dose of~     ponatinib in combination with 5-azacytidine and to learn if the highest dose level found can~     help to control FLT3-mutated AML or FLT3-mutated high-risk MDS. The safety of this~     combination will also be studied.~   "
56316|NCT02829827|"~     The purpose of the study is to evaluate the safety and tolerability, the pharmacokinetics and~     the efficacy of radiprodil in abolishing clinical spasms in subjects with drug-resistant~     infantile spasms~   "
56317|NCT02829814|"~     The present trial is designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets,~     taken daily at bedtime after 12 weeks of treatment in patients with fibromyalgia.~      The use of low-dose sublingual formulation of cyclobenzaprine (TNX-102 SL) dosed nightly for~     fibromyalgia is supported by the results of TNX-CY-F202 Phase 2b study -- the results provide~     strong evidence that TNX-102 SL 2.8 mg dosed nightly results in beneficial effects upon pain,~     sleep and other FM symptomatology.~   "
56318|NCT02829801|"~     The animal-assisted therapy (AAT) is now considered a non-drug care and is often used in~     geriatrics. Many studies have shown a link between the presence of the animal and the~     psycho-behavioral symptoms decrease in dementia (PBSD) such as depression, anxiety or~     irritability that affects their quality of life and improved cognitive abilities. However,~     many methodological flaws in these researches exist.~      The aim of the study is to evaluate the effectiveness of AAT on the well-being of patients~     with Alzheimer disease (AD) at the stage of Major Neuro Cognitive Disorder (NCD) at short and~     medium term (before care, during care (at the beginning and end of each session), 1 week~     after, 2 weeks and 1 month after the last session) compared to a group receiving the same~     stimulation without the dog's response.~      Patients will be seen in groups of 4 to 6 people at 8 workshops. 2 groups will be formed: AAT~     group versus control group. The only difference between these two groups is the intervention~     of the dog at each workshop in the AAT group.~      Each workshop will consist of three identical times. It will begin with a 15 minute~     introductory activity, the first goal will be to establish a relationship with patients~     (patients-patients and patients-caregivers) and a 40 minute cognitive stimulation, identical~     in the 2 groups, will be proposed and finally 5 minutes will be devoted to the closing of the~     session This study should highlight a positive effect of animal assisted therapy on the~     well-being, PBSD, depression, anxiety and cognitive abilities and a long-term retention of~     these positive effects.~   "
56319|NCT02829788|"~     The peritoneum is the second most common site of recurrence in patients with colorectal~     cancer. Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy improve the~     prognosis of these patients and incorporates surgical removal of all visible disease followed~     by chemical destruction of microscopic disease through chemoperfusion. The most validated~     predictors of outcome are preoperative tumor burden measured in terms of the peritoneal~     carcinomatosis index (PCI) and completeness of cytoreduction (CC score). Diagnostic~     laparoscopy prior to resection is widely used in hepatopancreaticobiliary and colorectal~     cancer and has been shown to be effective in excluding unnecessary laparotomy associated with~     higher morbidity.~   "
56320|NCT02829775|"~     This open label extension study will give an opportunity to the participants that have~     responded to the treatment with Pegylated-Interferon Alfa-2a (Pegasys) or Recombinant~     Interferon Alfa-2a (Roferon-A®) in prior clinical studies NO15753 (NCT00003542) for Renal~     Cell Carcinoma (RCC), NO15764 (NCT number not available) and NO16006 (NCT02736721) for~     Chronic Myelogenous Leukemia (CML), and NO16007 (NCT number not available) for Malignant~     Melanoma (MM).~   "
56321|NCT02829762|"~     The objective of the PREDOMOS study is to evaluate the impact of establishing a Program of~     geriatric and Social intervention associated techniques of Domotic and Remote assistance~     (PS-DR) on the improvement of quality of life of elderly patients, isolated or at risk of~     isolation, treated for locally advanced or metastatic cancer.~   "
56325|NCT02829710|"~     Management of analgesia and sedation is an integral component of the medical care of a~     critically-ill child. Its role is to assure comfort and safety to a patient undergoing~     painful cares and technical procedures; it can also be, in particular situations like acute~     respiratory distress syndrome or acute brain injury, a full processing treatment.~      Sedation involves, most of the time, the association of an opioid and a sedative. The use of~     these drugs is difficult in children, because of a specific metabolism, inducing tolerance~     and withdrawal in case of prolonged administration.~      The COMFORT-BEHAVIOR (COMFORT-B) scale is a validated, simple, reliable and reproducible~     score evaluating sedation and analgesia. Sedation scoring systems must be used regularly to~     avoid inadequate sedation.~      Excessive sedation is associated with poor outcomes like prolonged mechanical ventilation,~     longer hospitalisation and more frequent withdrawal symptoms. Adult and paediatric data~     suggest that goal-directed sedation algorithms allow a more appropriate adaptation of the~     treatment to the patient's need and permit a reduction in the duration of mechanical~     ventilation.~      The objective was to evaluate the impact of a nurse-driven sedation protocol in a paediatric~     intensive care unit on duration of mechanical ventilation, total doses and duration of~     medications, Paediatric Intensive Care Unit (PICU) length of stay, incidence of~     ventilator-associated-pneumonia and occurrence of withdrawal.~   "
56326|NCT02829697|"~     The aim is to investigate the effect of perineural administration of a series of different~     volumes of local anaesthesia (ropivacaine 0.2%) on nerve block duration and the variability~     of the duration in the common peroneal nerve and the sciatic nerve in healthy volunteers.~      The hypothesis is that nerve block duration is correlated to local anaesthetic volume, but~     only to a certain degree. After a sufficient volume a 'saturation level' will be reached, and~     nerve block duration will not increase further.~   "
56327|NCT02829684|"~     Prader-Willi Syndrome (PWS) is a rare syndrome with a prevalence of 15 to 20 000 at birth.~     PWS represents a large fraction of mental retardation syndromes due to a genetic cause and~     the most frequent cause of genetic obesity. The majority of the patients are seen by~     paediatricians. This syndrome is responsible for severe physical, psychological and social~     impairments.~      The diversity and the severity of the manifestations of this disease explain the requirement~     of multidisciplinary care which deserve specific evaluation. Today the follow-up and~     management of a great proportion of these patients are greatly insufficient if not absent.~      Teams strongly lack information on the natural history of this severe disease and on the~     factors involved in its evolution and the outcome of these patients throughout life. The~     present project is to implement a register in the whole country for children and adult~     patients~   "
56328|NCT02829671|"~     Suicide is a major health problem that causes annually a million death worldwild. Loneliness~     is known to be associated with suicidal ideation in minors and to be related with suicidal~     risk in elerly people. However little is known about this association in a middle-aged~     population. Loneliness is a modifiable factor with suitable psychotherapeutic measures, it is~     essential to improve the scientific and medical knowledge about the link between this feeling~     and suicide risk in a population of depressed patients in middle age.~      The main objective is the study of the relationship between loneliness and the occurrence of~     SB in major depressed adult population over 12 months.~      The secondary objectives are:~        -  Identification of risk factors (clinical, neuropsychological and biological) of the~          occurrence of SB within a clinical population and their interaction;~        -  Identification of predictive factors (clinical, neuropsychological, biological)~          therapeutic response to antidepressant in the context of depression.~   "
56329|NCT02829658|"~     Borderline personality disorder (BPD) is characterized by a pervasive pattern of instability~     and impulsivity. Several North American prospective studies support the high level of mental~     health care utilization in this population. There is little data in other systems of health~     organization, such as France. Furthermore, little is known on the variables associated with~     the mental health service utilization among BPD patients.~      The main objective was to compare the utilization of mental health care among BPD patients,~     to the general population and patients with another personality disorder (PD) and to describe~     the demographic and clinical factors associated with the group of patients who use the most~     health care.~   "
56330|NCT02829645|"~     Eating disorders (ED) are serious mental illnesses with an excess mortality and many affects~     in the quality of life of patients and thier relatives. Management of ED is very difficult :~     the prognosis remains relatively poor both in terms of remission rate and quality of life. In~     this context, the contribution of new strategies for pathophysiological exploration and the~     development of therapeutic options are crucial.~      In this project the investigators aim to constitute un cohort of patients from a day unit~     specialized in the management of ED. A prospective follow-up will be offered to patients to~     assess their clinical and psycho-social evolution. The overall objective is to identify which~     factors are prognostic of clinical improvement of the ED. We also want to better characterize~     patients that will migrate from diagnosis to another.~   "
56331|NCT02829632|"~     Brief Summary: This randomized clinical pilot will test the feasibility of having individuals~     self-monitor for 12 weeks and based on what the participants record be given feedback~     messages. The investigator will use this information to refine the questions and data~     collection procedures for the larger study.~      Participants will be randomized into 3 groups~        -  self-monitoring only~        -  self-monitoring w/ feedback messages~        -  self-monitoring w/feedback messages and group sessions Feedback messages will be~          delivered up to 4 times per day using a different schedule. The group sessions will be~          held in the 2nd, 4th and 8th week of the 12-week study.~      All participants will be asked to complete questionnaires and 2 assessment visits at baseline~     and 12 weeks.~   "
56332|NCT02829619|"~     Meal times differ from culture to culture. These differences may influence energy regulation~     and, consequently, body weight. Current studies support the notion that not only what but~     also when the investigators eat may have a significant role in obesity treatment. Recently,~     it has been shown that eating the main meal of the day, lunch in Spain, late in the day is~     predictive of difficulty in weight loss and decreased insulin sensitivity. This project aims~     to study in a Mediterranean population the potential influence of genetics and food timing on~     obesity, metabolic syndrome and weight loss.~   "
62488|NCT02748967|"~     The purpose of this study is to assess the safety and tolerability of different doses of~     ExPEC4V (JNJ-63871860) in healthy Japanese participants greater than or equal to [> =] 20~     years of age.~   "
56333|NCT02829606|"~     A device has been developed that has eye trackers integrated within the Head Mounted Display~     (HMD) and can remap text and images around the scotoma in real time to prevent information~     loss from a central scotoma. It can also carry out other types of image processing such as~     contrast enhancement and image magnification. The aim of this study is to assess the efficacy~     of this device on the visual performance of participants suffering from central vision loss,~     with and without remapping~   "
56334|NCT02829593|"~     You are invited to participate in a study designed to investigate the effects of diabetes~     mellitus, high and low glucose, and high blood insulin on the brain. You were selected as a~     possible participant because you fit into one of the following categories. a) you are either~     healthy and competent, are not pregnant and you have no known medical disease and therefore~     your glucose metabolism will be typical of a normal person, or b) you have diabetes.~   "
56335|NCT02829580|"~     Sickle cell disease (SCD) is an inherited disorder characterized by recurrent painful crises~     with ischemia resulting from vascular occlusion. Adults with SCD have increased arterial~     stiffness and reduced flow-mediated dilation (FMD), due to impaired release of substances~     such as nitric oxide.~      The present study assess the vascular properties of carotid and brachial arteries in children~     with SCD compared with a control group without cardiovascular risk factors.~   "
56336|NCT02829567|"~     The purpose of this study is to determine whether motivational interviewing is effective in~     improving oral hygiene in orthodontic patients wearing fixed appliances.~   "
56337|NCT02829554|"~     Background:~      Researchers are testing new methods for research projects. They want to see how people~     respond to different types of communication, including videos. They also want to learn how~     people respond to life events and how they pay attention to computer tasks. They want to~     learn about how various risks and threats affect the way people make decisions.~      Objectives:~      To learn how different stimuli and events affect the way people make decisions.~      Eligibility:~      Adults ages 18 and older with a U.S. computer address~      Design:~      Participants will be recruited online.~      Participants will take one of three studies online. Each study will take about a half hour.~      Participants in Study 1 will watch a short video from a popular movie then answer questions.~     They will also complete 2 questionnaires. One will be about how likely they think it is that~     they will experience different risks and threats. The other will be about goals for behavior~     change.~      Participants in Study 2 will write in detail about a life event. Then they will answer~     questions. They will also complete the same 2 questionnaires as Study 1.~      Participants in Study 3 will pay close attention to words and images on a computer. They will~     answer questions about attitudes toward different behaviors, products, and experiences.~   "
56338|NCT02829541|"~     The primary objective of the study is to evaluate the safety and tolerability of single oral~     doses of BIIB068 in healthy participants. Secondary objectives are to characterize the~     single-oral-dose Pharmacokinetic (PK) of BIIB068 in healthy participants, to determine the~     effect of food on the single-oral-dose PK of BIIB068 in healthy participants and to examine~     the effect of administration of the proton pump inhibitor (PPI) esomeprazole on the~     single-dose PK of BIIB068 in healthy participants.~   "
56339|NCT02829528|"~     An initial evaluation of Little Flower Yoga for Kids will be conducted in a small sample of~     18-30 Kindergarten and First Grade students (3-5 per class) enrolled in Girls Preparatory~     Charter School of the Bronx. The overall aim of this study is to ascertain the short and~     longer-term effects of Little Flower Yoga for Kids, a promising yoga and mindfulness program~     for children, which incorporates five elements (connect, breathe, move, focus, relax) to~     improve the child's ability to sustain attention and regulate emotions.~   "
56340|NCT02829515|"~     For the purpose of quality assurance, the Swedish Association for Otorhinolaryngology and~     Head and Neck surgery has developed several national registers concerning ear, nose and~     throat care. One of these is the National Tonsil Surgery Registry in Sweden (NTSRS). In NTSRS~     patients undergoing tonsil surgery for benign indications are included. Data regarding~     indication, surgical methods and techniques as well as patient reported outcomes measures are~     collected. The register is designed to facilitate description of clinical activities in a~     unit and help identify the need of clinical improvement programs. By compiling national data,~     the register can be used to describe clinical practice in a large national cohort.~   "
56341|NCT02829502|"~     This randomized controlled trial investigates the effect of a single dose of glucagon-like~     peptide-1 (GLP-1) receptor agonist in the subacute phase of stroke in humans. The primary~     endpoint is the mean flow velocity in the middle cerebral arteries measured by transcranial~     doppler and cortical oxygination measured by near infrared spectroscopy (NIRS). The secondary~     endpoints are changes in endothelial/inflammatory biomarkers in the blood, changes in the~     ankle-brachial index and changes in the reactive hyperaemia index measured by EndoPAT2000.~   "
56342|NCT02829489|"~     The purpose of this study is to evaluate the current state of nutrition care and patient~     related outcomes in patients with head, neck and esophageal cancers in North America, Europe~     and Australia.~   "
56343|NCT02829476|"~     Adolescent idiopathic Scoliosis (AIS) is the most common spine pathology. It is opposed to~     secondary scoliosis due to chronic diseases. Many hypotheses have been made to elucidate the~     origin of this illness. Recently, the melatonin pathway has been investigated as pinealectomy~     of the chicken creates a scoliosis that resembles AIS and melatonin supplementation reverses~     the process. In addition administration of melatonin to AIS patients improved the pathology.~     However this hypothesis has shown controversial results. Recent studies have demonstrated~     melatonin cellular resistance in osteoblastic cells from AIS patients. Melatonin acts through~     G protein coupled receptor (GPCR), mainly using the Gi pathway. In AIS osteoblasts, this~     pathway is blocked leading to a decrease in the inactivation of the adenylyl cyclase and~     therefore maintenance of high level of cyclic adenosine monophosphate (cAMP) concentrations~     in the cells. As modulation of cAMP is important for osteogenesis such resistance may be~     critical for the initiation or the development of AIS.~      Gi signalization is used by several other GPCR, thus, this hormonal resistance could~     logically be found in other hormonal or mediator pathways. A precedent study previously~     focused on ghrelin in AIS, and demonstrated that AIS patients possess elevated plasmatic~     values of ghrelin. This study also observed decreased response to ghrelin in AIS cultures~     osteoblasts.~   "
95985|NCT02310776|"~     Compare lesion detection of the automated breast ultrasound (ABVS) exam with the conventional~     handheld (HH) breast ultrasound (US) exam.~   "
56347|NCT02829424|"~     The overall purpose of this trial is to assess efficacy and safety of the combination of low~     doses of Methotrexate (MTX) with anti Tumor Necrosis Factor (TNF) alpha to improve initial~     efficacy and maintenance rate of anti-TNF alpha treatment in patients with psoriasis.~   "
56348|NCT02829411|"~     The project will test the strategy of integrating 25 hours of relationship education into an~     existing employment program for low-income individuals ages 18-30. It will use a 2-arm~     randomized controlled trial to test the effect of this full package of services on~     participants' employment outcomes and relationship outcomes.~   "
56349|NCT02829398|"~     The risk of delayed cerebral ischemia (DCI) after subarachnoid hemorrhage (SAH) is associated~     with large cerebral artery vasospasm, but vasospasm is not a strong predictor for DCI.~     Assessment of cerebral autoregulation with transcranial Doppler (TCD) may improve the~     prediction of DCI. The aim of this prospective study was to assess the value of TCD-derived~     variables to be used alone or in combination for prediction of DCI~   "
56350|NCT02829385|"~     This study makes an observation over the objective response rate of Apatinib and XELOX~     combination regimen in the first-line treatment of metastatic colorectal cancer. All the~     participants will receive the treatment of Apatinib and XELOX combination regimen.~   "
56351|NCT02829372|"~     The purpose of this study is to determine the safety profile and maximum tolerable dose (MTD)~     of GBR 1302 monotherapy in subjects with HER2 positive cancers~   "
56352|NCT02829359|"~     Hepatitis B virus (HBV) reactivation happens after liver resection for HBV-related~     hepatocellular carcinoma (HCC) patients, particularly for those with positive serum HBV-DNA .~     The incidence rate and risk factors of HBV reactivation after hepatectomy for serum HBV-DNA~     negative HBV-related HCC are unclear.~   "
56353|NCT02829346|"~     This study evaluates the peri-articular tranexamic acid injection in total knee arthroplasty~     which is an alternative route of administration for blood loss reduction. Half of~     participants will receive intravenous tranexamic acid injection, while the other half will~     receive peri-articular tranexamic acid injection during total knee arthroplasty.~   "
56354|NCT02829333|"~     The purpose of this study is to verify the effect of anesthetic technique on the change of~     postoperative serum vascular endothelial growth factor C and prostaglandin E2, and to explore~     the potential impact of the anesthetic technique on leiomyomas recurrence and growth after~     the surgery of abdominal myomectomy.~   "
56355|NCT02829320|"~     This 24-week, Phase 3, open-label, non-comparative, multicentre study aims to evaluate the~     efficacy and safety of GSK1278863 in Japanese hemodialysis (HD) patients with renal anemia~     not using erythropoiesis-stimulating agents (ESAs). The primary objective is to evaluate the~     initial response to GSK1278863 measured by hemoglobin (Hgb) levels in HD patients not using~     ESAs enrolled in this study. The study is designed to evaluate the appropriateness of the~     starting dose of GSK1278863 and of the GSK1278863 dose adjustment regimen to achieve or~     maintain the target Hgb levels. This study will consist of a 4-week screening period, a~     24-week treatment period (4-week fixed-dose period and a 20-week dose adjustment period), and~     a 2- to 4-week follow-up period.~   "
56356|NCT02829307|"~     GSK3128349 is a small protein molecule (biopharmaceutical) that binds to albumin in the body,~     and by itself, has no pharmacological action. A pharmacologically active drug can be attached~     to GSK3128349 with the goal of changing the distribution and/or duration of action of the~     attached drug. This study will determine the distribution and pharmacokinetics (duration) of~     GSK3128349 itself after a single intravenous infusion. GSK3128349 has been labeled with and~     the radioisotope 89Zirconium allowing it to be visualized in the organs of the body using a~     PET scanner at multiple time points after GSK3128349 dosing. The data from this study will~     help predict the distribution of future drugs attached to GSK3128349. The total duration of a~     subject's participation is about approximately 10 weeks, including the screening period.~   "
56357|NCT02829294|"~     This is a prospective, open-labeled clinical trial. Subjects that qualify for enrollment and~     provide informed consent will be treated with a novel topical cerumen (earwax) removal~     product. The primary goal of this pilot study is to gain an understanding of the safety and~     efficacy of this novel product.~   "
56358|NCT02829281|"~     Introduction: Osteoarthritis of the knee is a very common disease. However there are few~     treatment options for these patients. Botulinum toxin type A is an option for chronic pain.~     If the investigators prove effectiveness of its use for intra-articular analgesia, Botulinum~     toxin type A can be useful for treat these patients.~      Objective: Compare the effectiveness of the use of intra-articular corticosteroid versus~     Botulinum toxin type A in the treatment of patients with knee osteoarthritis.~      Methods: A prospective controlled randomized double blind studied with three groups (n = 35~     each group) of patients with symptomatic osteoarthritis of the knees receive intra-articular~     medication in a single moment will be undertaken. The three groups will be: Botulinum toxin~     type A Group: patients who receive 100 units of botulinum toxin; hexacetonide of~     triamcinolone Group: patients who receive 40mg of triamcinolone hexacetonide, and saline~     group: patients who receive 2ml of normal saline. Patients will be assessed by evaluators ~     blind  in 4 times during 12 weeks of follow-up with clinical assessment instruments (pain,~     quality of life questionnaire as short form 36 questionnaire) , functional ( WOMAC~     questionnaire) , and ultrasound (quantitative and semi quantitative measure of synovial~     hypertrophy and semi quantitative Power Doppler ) .The following statistical tests will be~     used : Student's t test, Mann - Whitney , chi- square test and ANOVA for repeated measures .~     Will be considered as statistical significance the difference of 5 %.~   "
56359|NCT02829268|"~     Wolfram syndrome is a rare genetic disorder characterized by juvenile-onset diabetes~     mellitus, diabetes insipidus, optic nerve atrophy, hearing loss, and neurodegeneration. The~     purpose of this study is to assess the safety and tolerability of dantrolene sodium in~     patients with Wolfram syndrome. In addition, we will assess the efficacy of dantrolene sodium~     on the cardinal manifestations of Wolfram syndrome, including visual acuity, remaining beta~     cell functions, and neurological functions.~      There is a screening period up to 56 days, a 6-month treatment period with an optional~     extension phase up to 24 months, and a 4-week safety follow-up period. Study assessments~     include medical & medication history, physical exams, neurological exams, eye exams,~     endocrine exams, vital signs, height, weight, electrocardiograms, blood and urine tests,~     pregnancy test if applicable, and questionnaires.~   "
56361|NCT02829242|"~     Some robotic endoscopic surgeries require a steep Trendelenburg position and a carbon dioxide~     pneumoperitoneum. This minimally invasive approach has the advantages of less postoperative~     pain, shorter hospital stay and faster recovery. After prolonged operative time in a~     Trendelenburg position rare but significant complications are a cerebral oedema or a well leg~     compartment syndrome.~      Well leg compartment syndrome results from inadequate perfusion in the lower limbs and the~     perfusion pressure is decreased proportionally to the lower extremity elevation. The~     condition can lead to release of intracellular proteins and myoglobinuria, hyperpotassaemia~     and metabolic acidosis followed by cell necrosis. The risk for tissue damage increases after~     4 hours in a Trendelenburg position.~      If not promptly diagnosed and treated, a compartment syndrome has devastating complications~     like permanent dysfunction, limb loss, renal failure or even death.~      There are no specific guidelines for diagnosis and for the timing of surgical decompression.~     Fasciotomy is a clinical decision. There is no universal agreement at which compartment~     pressure irreversible muscle damage occurs.~      The only objective diagnostic tool available is currently to measure the intramuscular~     pressure, however this is invasive, painful and may yield unreliable results. An~     intracompartment pressure of 0- 10mm Hg is the normal range.~      Near Infrared Spectroscopy (NIRS) monitors are validated and approved to measure cerebral and~     somatic tissue oxygenation below the sensors and may help detecting promptly a compartment~     syndrome.~      Therefore, the investigators designed the present study to detect a change in the tissue~     oxygenation in the lower legs during robotic assisted, laparoscopic surgery in the~     Trendelenburg position.~   "
56362|NCT02829229|"~     The purpose of this study is to determine the effect of the community-based obesity treatment~     (PP), compared to usual care (UC), on changes in maternal weight over 12 months.~   "
56363|NCT02829216|"~     The objective is to measure the frequency, functionality and phenotype of bone marrow-derived~     mesenchymal stromal cells in patients after allogeneic hematopoietic stem cell~     transplantation. Furthermore, the immune cell infiltrate of the bone marrow will be monitored~     at the same time. These results will be correlated with the extent of cytopenia and clinical~     graft-versus-host disease grading.~   "
56364|NCT02829203|"~     Frailty is an important risk factor for cardiovascular disease (CVD), recent data has shown~     significant association between pre-frailty and the risk of incident for CVD, irrespective of~     any classical cardiometabolic risk factors, suggesting that targeting pre-frailty as a~     potentially reversible risk factor for CVD in the elderly. Patients with high levels of~     frailty have an increased risk in post-operative period, with more time in mechanical~     ventilation, length of stay and complications (stroke and death) compared to patients with~     low frailty levels. The investigators hypothesized that pre-frailty patients also have a~     higher surgical risk compared to no-frailty patients.~   "
56365|NCT02829190|"~     The phase-contrast MRI offers the advantage to combine precisely vascular flow measurements~     data with morphological images.~      Even if the anatomy of the external carotid artery is well known, data obtained through Phase~     contrast MRI could permit to progress in several fields of cranio-maxillofacial surgery as~     for example arteriovenous malformations,radionecrosis, head and neck micro-reconstructive~     surgery.~      The aim of this study is to establish and develop Phase-contrast MRI sequences for vascular~     flow characterization branches of the external carotid artery in healthy patients and in~     pathological cases.~   "
56366|NCT02829177|"~     The objective is to determine if lowering serum uric acid by means of allopurinol in the~     course of kidney disease may be effective in preventing or improving albuminuria and renal~     function in Type 1 Diabetic patients. The study is a double blinded, randomised,~     placebo-controlled cross-over clinical trial.~   "
56367|NCT02829164|"~     Primitive kidney disease IgA, represented by Berger's disease and rheumatoid purpura~     nephropathy, are the first cause of kidney failure from chronic glomerulonephritis: changes~     in 20 years to end-stage renal failure is described in 10 to 30 % of cases in Berger's~     disease and in 15 to 20% of cases in nephropathy HSP. These two pathological entities share~     biological and histological characteristics, as well as common pathophysiological mechanisms,~     particularly the production of abnormally glycosylated IgA1 promoting their proliferation in~     the mesangium. Tonsils part of Iga abnormal production sites that would be associated with an~     infectious stimulus, tonsillectomy has been studied as a possible treatment in primitive IgA~     nephropathy. The benefit of tonsillectomy is controversial: many Japanese studies demonstrate~     its effectiveness in terms of reduction of proteinuria, improved renal function in the long~     term regression of histological lesions and reduced risk of relapse following clinical~     remission whereas European studies do not suggest its effectiveness in treating IgA~     nephropathy. In this context, the aim of our study is to describe the scope of practice of~     tonsillectomy in the treatment of primary renal disease in IgA child in the inter East region~     and describe the short renal become Strasbourg end of the cohort that received this~     treatment.~   "
56368|NCT02829151|"~     -  Prospective, randomized, controlled, multi-center study~        -  A total of 390 subjects with critical limb ischemia will be included according to~          inclusion and exclusion criteria.~        -  Patients will be randomized in a 1:1:1 manner into triple antiplatelet therapy (TAP:~          aspirin, clopidogrel, cilostazol) group, dual antiplatelet therapy (DAP: aspirin,~          clopidogrel) A group, or DAP (aspirin, cilostazol) B group.~        -  All patients will be treated with angioplasty for critical limb ischemia.~        -  Patients will be followed clinically for 1 year after the procedure.~        -  Ankle-brachial index and Image study follow-up (Duplex US or CT angiography) will be~          performed at 1 year.~   "
56386|NCT02828917|"~     MedJ-01 Ridaforolimus Eluting Coronary Stent System is a single use device/drug combination~     product comprising:~        -  A mounted Cobalt Chromium (CoCr) alloy based stent~        -  A Rapid Exchange (RX) Coronary System Delivery System~        -  A Poly n-butyl methacrylate (PBMA) and CarboSil®Polymer matrix coating~        -  Ridaforolimus drug - CAS Registry Number: 572924-54-0 MedJ-01 is indicated for improving~          coronary luminal diameter in patients with symptomatic heart disease due to lesions in~          vessels with reference diameters of 2.5 mm to 4.25 mm, including complex lesions.~      JNIR01 is aimed at assessing TLF at one year with the MedJ-01 stent in a Japanese patient~     population to show equivalence to the results of the BIONICS Trial.~   "
58053|NCT02807051|"~     This will be an open-label, single-center, crossover, one-way, drug-interaction study to~     evaluate the effect of 500 mg clarithromycin BID (dosed to steady state) on the PK of a~     single 400-mg dose of pacritinib in healthy male and female subjects.~   "
56369|NCT02829138|"~     There are many health benefits associated with the consumption of omega-3 dietary fats.~     Omega-3 fats, specifically eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), can be~     found in marine food products such as fatty fish, in fortified products such as eggs and~     milk, or in dietary supplements such as fish oil. Despite numerous health benefits, it is~     well documented that most people in Western society are not meeting the recommended daily~     amounts of EPA and DHA omega-3 fats.~      The overall objective of this study is to examine whether providing young adults (18-25~     years) with personal genetic information changes behavior with regards to omega-3 fat~     consumption. In order to achieve this objective, study participants will be divided into two~     groups: 1. Genetic and 2. Non-Genetic. The Genetic Group will be provided with their~     personalized information regarding a common gene variant in addition to general information~     regarding the health benefits of omega-3 fats, while the Non-Genetic Group will only receive~     the general information. Primary outcomes studied will include dietary habits and secondary~     outcomes include blood markers of cardiometabolic health.~   "
56370|NCT02829125|"~     The concept of early rehabilitation (ERAS: enhanced after-surgery recovery) was introduced by~     Kehlet et al. in 1995, as part of the colon surgery. This program is a support for patients~     combining laparoscopic surgery, epidural analgesia, early refeeding and rapid mobilization of~     patients. This strategy targets multiple elements (20 items) to support pre-, intra- and~     postoperative patients. This reduces the pain and the different organ dysfunction induced by~     surgical stress significantly decreasing length of hospital stay, postoperative morbidity and~     costs.~      Furthermore, early mobilization of patients is fundamental to the ERAS method. Few studies~     have analyzed the influence of preoperative exercise on postoperative rehabilitation.~   "
56371|NCT02829112|"~     Shulman fasciitis or eosinophilic fasciitis (EF) is a rare inflammatory disease, usually~     benign but disabling, described by Shulman in 1974. The diagnosis is suggested by the clinic,~     confirmed by MRI and confirmed by histology, there really no published diagnostic criteria~     validated for this rare disease. The low number of cases reported in the literature reflects~     the difficulty of studying the epidemiology of this disease, to establish and evaluate~     therapeutic strategies and to assess prognosis. Work on this subject are few. To our~     knowledge, no study has previously used to estimate the incidence and prevalence of this~     disease. Therefore, the investigators want to determine the prevalence of FEs in Alsace in~     2016 by a study capture-recapture using several independent sources of identification of~     cases in order to have recent epidemiological data and learn more about this disease.~   "
56372|NCT02829099|"~     The primary purpose of the study is to determine the recommended Phase 2 dose (RP2D) and~     schedule of JNJ-64457107 when administered intravenously (IV) to participants with advanced~     stage solid tumors in Part 1 and to further characterize the safety of JNJ-64457107 when~     administered IV to participants with non-small cell lung cancer (NSCLC), pancreatic cancer~     and cutaneous melanoma in Part 2.~   "
56373|NCT02829086|"~     The US Committee for Refugees and Immigrants (USCRI) will be conducting an evaluation of a~     healthy marriage and relationship program developed by USCRI titled Refugee Family~     Strengthening (RFS) Program. This program is funded through an initiative of the~     Administration for Children and Families, Office of Family Assistance (OFA).~      The study is intended to measure if the identified interventions improve the well-being of~     individuals and families within the refugee and immigrant population served by USCRI.~     Outcomes to be measured include behavioral outcomes and perceptual changes towards healthy~     relationships, family development, and positive home environment. The study will examine the~     following:~        1. Participants will identify utilizing healthy marriage and relationship skills.~        2. Participants will report an increase in satisfaction with conflict management with~          others after completion of the relationship workshop series.~        3. Participants will report an increase in quality and time spent with children.~        4. Participants will report an increase in economic stability.~   "
56374|NCT02829073|"~     The most current data indicate that tinnitus and hearing impairment are the Number 1 and 2~     disabilities associated with service in Operations Iraqi Freedom and Enduring Freedom.~     Tinnitus can result from exposure to continuous noise from vehicles, generators, and other~     equipment, and from blast, or impulse noise from friendly-or opposing-forces weapon systems.~     Thus, tinnitus caused by both long-term noise exposure and acute acoustic trauma is an~     obstacle to be overcome in return-to-duty decisions and represents a serious liability to the~     retention of a healthy and fit force. Until recently, there has been no treatment that has~     been clinically validated as consistently effective. The development of the Neuromonics~     Tinnitus Treatment sought to overcome the practical limitations of previously available~     approaches (e.g. tinnitus maskers and biofeedback). While these studies have demonstrated the~     efficacy of the Neuromonics Tinnitus Treatment over alternative therapies, these trials~     studied target populations that may not be representative of the typical Soldier experiencing~     tinnitus.~      One hundred and twenty (120) Soldiers or veterans with debilitating tinnitus will be~     recruited and divided into groups treated with two treatments, the Neuromonics Tinnitus~     Treatment Program which includes the use of the Neuromonics Oasis™ treatment device and a~     similarly-treated device using a placebo treatment. The study uses a randomized, double-blind~     design. The effectiveness of the treatments will be assessed using standard audiometric~     procedures and tinnitus subjective questionnaires.~      This study will allow the Office of the Surgeon General of the Army to provide direction~     regarding the Neuromonics Tinnitus Treatment Program (NTTP) for alleviation of debilitating~     tinnitus that adversely affects Soldier deployability and operational performance. Retention~     of a fit force and improved quality of life for active-duty Soldiers are important issues~     associated with a successful approach to the treatment of tinnitus.~   "
56375|NCT02829060|"~     This study will be a multi-institutional randomized clinical trial of a short course of~     pre-operative antibiotic prophylaxis in addition to perioperative antibiotics prior to~     undergoing percutaneous nephrolithotomy. The select patient population will be those patients~     deemed to be at a moderately increased risk of postoperative infectious complications. These~     higher risk patients are those with indwelling urinary drainage tubes and those with a~     positive preoperative urine culture.~   "
56387|NCT02828904|"~     The risk of venous thromboembolism (VTE) associated with the use of chlormadinone acetate~     (CMA) is currently unknown as the available data have significant limitations and lack data~     on direct comparison between levonorgestrel (LNG) and CMA containing COCs. This new study is~     designed to assess the VTE risk associated with CMA containing COCs compared to LNG~     containing COCs in a large case-control study.~      The objective of this study is to compare the VTE risk of COCs containing CMA 2mg / EE 30µg,~     compared to COCs containing LNG 0.15mg and 30µg ethinylestradiol (EE).~   "
56488|NCT02827591|"~     This prospective, clinical, observational trial compares the measured value with quantitative~     ultrasonic (preoperatively) Elastic modulus E (kPA) with the measured value with quantitative~     ultrasonic Elastic modulus E (kPA) in vitro (postoperatively) and with the experimental~     measurement done in vitro (postoperatively) of lower uterine segment of women who underwent~     second cesarean section.~   "
56376|NCT02829047|"~     The study is a prospective, multicenter, open-label, single-arm study, to evaluate the~     tolerability, safety and efficacy of the Vibrant Capsule in relieving constipation.~      One arm will be assessed: Vibrant Capsule administered with a sequence of one per day for 2~     days, followed by one day without, one per day for 2 days followed by one day without, etc.~     (14 capsules in 3 weeks).~      The study will have one interim analysis.~      Patients will follow a 2 weeks baseline period and then take the Vibrant Capsule for a~     treatment period of 6 weeks.~      Data reporting will be done on an electronic Case Report Form and an eDiary. During the 2~     weeks of baseline, patients will be asked to refrain from taking any medication or supplement~     to relieve their constipation.~      After 14 days the patients will return and eligibility will be re-assessed. Patients will be~     trained on how to use the base unit.~      Patients will be instructed to complete a simple patient eDiary each day throughout the~     duration of the study. After 3 weeks of treatment, the patient will attend for evaluation and~     to receive new capsules. A final visit will take place at the end of the 6 week treatment~     period.~      Patients will receive phone calls up to twice per week and patient compliance will be~     monitored during the 8 weeks of the study.~   "
56377|NCT02829034|"~     This study is looking to see if giving ranolazine to subjects on stable pulmonary~     hypertension therapies but with right ventricular dysfunction (RVEF <45%) will improve their~     health by improving right ventricular (RV) function.~   "
56378|NCT02829021|"~     This study evaluate diagnostic accuracy of dynamic infrared thermography compared to~     mammography (reference test) in breast cancer diagnostics. Women aged 50-70 years, selected~     for assessment after mammography screening were invited to dynamic infrared thermography~     before clinical mammography and further examination.~   "
56379|NCT02829008|"~     This is a single-center, open, randomized, controlled phase 2 clinical trial designed to~     compare low-dose-bevacizumab and pemetrexed with TPC in metastatic HER2-negative breast~     cancer patients after failure of taxanes and anthracycline-containing regimens.~   "
56380|NCT02828995|"~     The Evaluating the iNfluence of Diabetes STIGma on Medication Adherence: The ENDSTIGMA~     Study was designed to develop a comprehensive diabetes stigma survey measure. The draft~     measure will be piloted with approximately 50 patients visiting the Vanderbilt University~     Medical Center (VUMC) Diabetes Clinic. This pilot data will be used to validate the new~     survey measure and to determine if any questions in the diabetes stigma measure are~     predictive of diabetes medication adherence.~   "
56381|NCT02828982|"~     The goal of this research is to determine the effectiveness of a powered prosthesis compared~     to an unpowered prosthesis during short bouts of walking, extended periods of walking (to~     fatigue), and performance in the community.~   "
56382|NCT02828969|"~     Conduct disorders are defined as repetitive and persistent pattern of behavior in which the~     basic rights of others or major age-appropriate norms are violated. So defined, these~     disorders are at the crossroads of psychiatry, social field and justice. Conduct disorder~     management is a public health issue and a societal question. Conduct disorders affect 5 to 9%~     of 15-year old boys.~      Care management of children and adolescents admitted for disruptive behaviors in emergency~     rooms is an issue. No consensus or official recommendation exists. However, use of emergency~     care in this context is increasing in most western countries and it exposes to several risks~     (inappropriate use of hospitalizations, social rupture, ignorance of comorbidities and~     suicide risk). The Trajectories project is designed to describe children and adolescents with~     disruptive behaviors, their care management and to follow their life trajectory and~     psychiatric evolution after admission to emergency rooms. Better understanding this~     population will improve their medical and social care management, thereby giving~     professionals the right tools.~      The main objective of this project is to implement a multidisciplinary and integrative~     research combining clinical considerations and social sciences to determine the trajectory~     of this population.~   "
56383|NCT02828956|"~     By use of several questionaires, this study aimed at an investigation of the changes in~     motivation, symptoms, self-esteem and coping style in adolescent patients with anorexia~     nervosa.. The psychometric properties of the Anorexia Nervosa Stages of Change Questionnaire~     (ANSOCQ) and its relation to coping style and self-esteem were assessed. After a treatment~     period of nine months, clinical AN diagnosis and the body mass index (BMI) were re-assessed.~     Besides construct validity of the ANSOCQ, its predictive validity in terms of predicting the~     outcome of AN was assessed.~   "
56384|NCT02828943|"~     The purpose of the present study is to determine the utility and effectiveness of combined~     inspiratory (IMT) and expiratory muscle training (EMT) in improving ventilatory function in~     people who are disabled by long-term stroke (greater than 8 months following onset) with~     hemiparesis or hemiplegia. xx subjects will be randomized into 2 parallel groups in which the~     experimental group will undergo combined IMT and high-resistance EMT and the comparison group~     will undergo IMT with low- resistance EMT. Both training techniques involve breathing through~     a tube with known amounts of resistance. Subjects will perform the breathing maneuvers for 10~     repetitions, twice daily, 5 days per week for 4 weeks, in the home environment. Adherence~     will be monitored by reminder telephone calls at least weekly. Outcomes will be assessed~     using maximum inspiratory and expiratory pressures and standard pulmonary function testing.~   "
56385|NCT02828930|"~     The purpose of this single-center, open-label, non-randomized study is to assess the~     excretion balance, pharmacokinetics, metabolism and absolute oral bioavailability of~     [14C]-labeled idasanutlin administered orally and [13C]-labeled idasanutlin administered~     intravenously in a single cohort of eligible participants. Participants will be screened for~     participation in this study within 21 days of receiving the first dose of study drug on Day~     1. Treatment period will continue up to Day 28 after which participants will enter 28 day~     follow-up or the optional treatment extension of idasanutlin, depending on safety parameters~     and as per opinion of the Investigator.~   "
56388|NCT02828891|"~     This is a single center, prospective study to calculate cerebrospinal fluid pressure (CSFp)~     using a non-invasive device and assess its role in the development of optic neuropathy due to~     glaucoma or idiopathic intracranial hypertension (IIH). The study also aims to assess whether~     CSFp differs between untreated and treated patients with glaucoma, ocular hypertension, IIH,~     and other ocular diseases that may be associated with CSFp differences.~   "
56389|NCT02828878|"~     Interventional, open label, Phase I/II, Safety and Proof-of-Concept Study, with a follow up~     period of 180 days after the transplantation of ApoGraft.~   "
56390|NCT02828865|"~     Liver cancer including primary hepatocellular carcinoma (HCC) and metastatic liver cancers is~     one the most common malignancies in the world. Over 10000 new cases per year are diagnosed in~     Taiwan. Despite the many treatment options, the prognosis of HCC remains dismal. More than~     8000 people died of this cancer every year in Taiwan. A majority (70% to 85%) of patients~     present with advanced or unresectable disease. In contrast, small liver cancers can be cured~     with an appreciable frequency. Five-year disease-free survival exceeding 50% has been~     reported for surgical resection, and for the inoperable patients who do not have vascular~     invasion or extrahepatic spread. Radiofrequency ablation (RFA) is recommended as an~     alternative curative therapy. However, the main drawback of RFA is its limitation to tumor~     size and location. The tumors larger than 5 cm in diameter or located adjacent to vessels,~     could not be ablated completely sometimes.~   "
56391|NCT02828852|"~     The objective is to compare women's platelet answer in the last month of pregnancy to women~     old enough to procreate, no pregnancy and without hormonal treatment.~      The hypothesis of research is that the decrease of platelet answer in pregnant women could~     not only limit the occurence of embolic accidents but also explain the lowest incidence of~     the arterial thrombosis in comparison with the venous thrombosis.~   "
56392|NCT02828839|"~     The objective of the study is to assess the design features of a modified stainless steel~     access needle (single use disposable) in a clinical setting and a disposable, single use,~     custom-made, polymer needle guide used in conjunction with a rectal ultrasound probe. The~     disposable stainless steel access needle may be used with or without the disposable needle~     guide, but will always be used with ultrasound image guidance and a biopsy gun. The primary~     purpose of the single-use disposable access needle is to guide the use of a biopsy gun to~     obtain a tissue sample from the patient's prostate gland through a percutaneous puncture of~     the perineum. The primary purpose of the disposable needle guide is to stabilize the needle~     biopsy and better approximate the most direct path to the prostate.~   "
56393|NCT02828826|"~     At home, maintenance, physical performance declines more or less rapidly from 6 weeks~     depending advancing age and duration of the training period . It is feared that the advice or~     prescription of regular physical maintenance at the exit of the service, has only adherence~     to the 50% like the medication prescribed. A US study of 2000 on the observance of healthy~     living recommendations, despite the many messages promoting physical activity, shows that~     only 24% of Americans aged 65 to 74 were taking physical activity regular. There are no~     French-date data.~      If physical maintenance is routinely recommended for the elderly living at home, so the way~     to encourage these people to practice more often possible these recommendations remains~     therefore a problem of public health.~      The recent OSSEBO study (intervention for the prevention of injurious falls in elderly women:~     background and design) recalled the interest to propose a program of physical exercise to~     reduce trauma and falls in the elderly. It also shows the possibility to implement an~     effective program on a long-term and large scale in France. The study allowed patients to~     participate in collective sessions of physical exercises, within the framework of an~     association. Patients were invited to continue their home exercises they had learned.~      Also, the investigators hypothesize that the monthly telephone coaching , directed by the~     physical therapist following a physical fitness exercise program which they have been trained~     during their hospitalization in SSR , would allow older patients to maintain fallers their~     physical performance at home for at least 6 months after leaving~   "
56394|NCT02828813|"~     This study investigates the neural mechanisms of motor and cognitive networks using cognitive~     assessment, reaction time measurement, high-density EEG and fMRI.~   "
56395|NCT02828800|"~     The purpose of this study is to realize a cartography of the allodynic and hypoasthetic~     territories associated with a neuropathic pain appearing in patients who underwent a Total~     Knee Arthroplasty (TKA)~   "
56396|NCT02828787|"~     The main objective of this study is to identify by functional and structural MRI which are~     the brain areas activated in various pruritic situations to deduct a model describing the~     different causes of pruritus.~      The investigators are going to compare two chronic pruritus conditions (histaminergic~     urticaria and non histaminergic: psoriasis) to a healthy control group.~      The secondary objective of this study is to specify a classification index from the~     physiological results obtained by brain imaging to differentiate multiple types of pruritus.~   "
56397|NCT02828774|"~     Using phage libraries extensively pre-absorbed on a series of normal cell types, we will~     isolate phage specifically internalized by B-CLL cells from newly diagnosed and untreated CLL~     patients. Peptide sequences are then derived by Next Generation Sequencing (NGS). NGS-based~     studies are contributing to an improved understanding of cancer heterogeneity in order to~     tailor treatment to patients based on the individual makeup of their tumor. However the use~     of NGS to derive phage displayed peptide sequences is so far rare (22). Traditionally, after~     exposure to a target and recovery by elution, the phage clones are isolated by titration on~     bacterial lawns. It is technically demanding and labour intensive to select and analyze more~     than about 15 of the sometimes thousands clones recovered. Therefore information on other~     potentially important sequences is missed. NGS allows sequencing of the entire recovered~     phage pool and provides far more detailed bioinformatic analyses of peptide sequences or~     motifs. RNA from the CLL cells is used for RNA-seq expression sequencing. The wide~     application of NGS in combination with bioinformatics tools has begun to revolutionize cancer~     research, diagnosis and therapy. The peptide and RNA sequencing data will afford~     bioinformatic testing of correlations of exome expression and clinical parameters with the~     pattern of peptide sequences internalized by CLL cells of different patients. This~     information is crucial to answering questions 1, 2 and 3 discussed on page 1 above. The~     results of this analysis will probably not allow identification of specific receptors~     targeted by the peptides. The aim at this stage of the research is to identify candidate~     targeting peptides. Once identified, further research will be needed to identify the~     receptors to which they bind. Regarding question 4, there is currently very little published~     information on the therapeutic potential of PDCs in leukemia. Using two peptides we have~     isolated that target murine A20 leukemic cells, we will prepare multi-drug PDCs (using~     technology we have developed) and in an animal model, test their ability to enhance the~     survival and quality of life of CLL bearing animals.~   "
56398|NCT02828761|"~     This research asks whether coronary calcium scoring, a non-invasive test based on computed~     tomography scanning, is a better way to diagnose chest pain patients than other currently~     used methods. Three of four patients will undergo calcium scoring and the remaining patients~     will receive standard care.~   "
56489|NCT02827578|"~     Efficacy and Safety of Tamsulosin/Solifenacin Combination therapy in Patients with voiding~     symptoms and moderate to severe storage symptoms due to Benign Prostate Hyperplasia : a~     randomized, double blinded, parallel design, active controlled, multi-center, phase 3~     clinical trial~   "
56490|NCT02827565|"~     The objective of this study is to optimize the search by next-generation sequencing (NGS)~     mutations in the KRAS, BRAF and NRAS on circulating tumor DNA and compare the genetic~     profiles obtained with those from tumors embedded in paraffin~   "
56399|NCT02828748|"~     Chronic intestinal inflammation characterizes inflammatory bowel diseases (IBD), which~     consist mainly of Crohn's disease and ulcerative colitis. The exact etiology is unknown for~     both diseases and therapeutic attempts aimed at down-regulating intestinal inflammation use~     both mediator-specific and nonspecific immune suppression. These attempts cause considerable~     side effects. Also, IBD patients are different in their genetic background and pathology. It~     was previously shown that products based on marijuana (Cannabis sativa) produce beneficial~     effects for patients with IBD, and medical cannabis-based products were formerly proven to~     have anti-inflammatory activity in laboratory experiments and in clinical tests. However, it~     is unknown how C. sativa-based medical products exert their effect in IBD and additional~     research and development should be done. One issue to be resolved in the process of~     medicalization of C. sativa is the base for the differences in patient response to different~     C. sativa lines, in order to fine-tune C. sativa -based treatment to IBD patients.~      For this aim of fine-tuning C. sativa -based treatment to IBD patients, we characterized the~     chemical composition of different C. sativa lines and their anti-inflammatory activities on~     colon cells lines. Extracts of C. sativa lines were prepared using various methods and~     cannabinoids and terpenoids profile was determined by chemical analysis. We found that~     different compounds have different effects on inflamed colon cell lines, leading to changes~     in interleukin secretion, inflammation markers and gene expression in the treated colon~     cells. In addition, we have developed a unique system relevant for personalized medicine in~     IBD. This system allows a patient-specific determination of the effect of C. sativa -based~     treatment. Following, clinical tests will be conducted aiming to develop cannabis-based~     products from different C. sativa lines, with anti-inflammatory activity that is effective~     and optimized for the different IBD patients.~   "
56400|NCT02828735|"~     The purpose of the study is to evaluate the use of subcutaneous impedance measured with an~     implanted Medtronic Reveal LINQ™ insertable cardiac monitor (ICM) as respiratory rate~     monitor.~   "
56401|NCT02828722|"~     The purpose of this study is to determine whether the environmental simulation of daytime and~     night time alternation as well as by the nutrition protocol corresponding to the daily rhythm~     are beneficially affect the recovery of patients treated in the Intensive Care Unit (ICU)~     requiring mechanical ventilation.~   "
56402|NCT02828709|"~     Irreversible Electroporation (IRE) is an emerging technique delivering electrical pulses to~     ablate tissue, with the theoretical advantage to overcome the main shortcomings of~     conventional thermal ablation. Recent short-term research showed that IRE for the ablation of~     renal masses is a safe and feasible treatment option. In an ablate and resect design,~     histopathological analysis 4 weeks after radical nephrectomy demonstrated that IRE targeted~     renal tumors were completely covered by ablation zone. In order to develop a validated~     long-term IRE follow-up study, it is essential to obtain clinical confirmation of the~     efficacy of this novel technology. Additionally, follow-up after IRE ablation obliges~     verification of a suitable imaging modality. The objectives of this study are the clinical~     efficacy and safety of IRE ablation of renal masses and to evaluate the use of~     cross-sectional imaging modalities in the follow-up after IRE in renal tumours.~      This is a prospective, human, in-vivo study among 20 patients presenting with solid enhancing~     SRM on cross sectional imaging suspect for renal cell carcinoma (RCC). Preoperatively,~     imaging is required through Magnetic Resonance Imaging (MRI), Contrast-enhanced ultrasound~     (CEUS) and contrast-enhanced Computed Tomography (CT). Furthermore, serum creatinine levels~     and VAS scores are obtained. A biopsy of the SRM will be performed in preoperative setting.~     IRE ablation will be performed using CT-guidance and ablation success will be measured~     directly after the ablation through contrast-enhanced CT. Device related adverse events (AE)~     will be registered using the Common Terminology Criteria for Adverse Events (CTCAE) version~     4.0 guideline. One week post ablation only CEUS and MRI will be performed to limit exposure~     to ionizing radiation. At 3 months, 6 months and 12 months post ablation CEUS, MRI and CT~     will be performed. Additionally, at these time points serum creatinine levels and VAS scores~     will be obtained, and quality of life will be assessed through SF-36 questionnaires. Residual~     and recurrent disease will be assessed through tissue enhancement on cross sectional imaging.~   "
56403|NCT02828696|"~     This study evaluates the effectiveness of a minimally invasive treatment, consisting of~     partial polymer-infiltrated-ceramic-network (PICN) restorations, used in case of~     rehabilitation of advanced and generalized dental wear over a period of 5 years.~   "
56404|NCT02828683|"~     The aim of the study is to demonstrate the safety and efficacy of the TCD-10023 (Ultimaster)~     sirolimus eluting stent in patients with acute ST-elevation myocardial infarction (STEMI), by~     proving superiority with respect to in-stent late loss at 6 months to the Kaname bare metal~     stent and non-inferiority with respect to Target Vessel Failure (TVF) at 12 months.~   "
56405|NCT02828670|"~     T follicular helper (TFH) cells represent a T cell subset dedicated to the activation of B~     cells. They have been involved in the pathogenesis of autoimmune diseases in humans such as~     lupus and Sjögren disease. We recently showed that TFH are implicated in the activation of~     autoreactive B lymphocytes during ITP. Autoimmune hemolytic anemia (AIHA) is an autoimmune~     disease due to antibodies targeting red blood cells. To date, the role of TFH in the~     pathogenesis of AIHA is not known.~      We hypothesize that AIHA is associated with an increase in the number and/or function of TFH,~     that could participate in the activation of autoreactive B lymphocytes.~   "
56406|NCT02828657|"~     A prospective, multicenter, open-label, post-approval study of the safety and effectiveness~     of ORBERA™ as an adjunct to weight reduction for obese adults (22 years of age and older)~     with a Body Mass Index (BMI) of ≥ 30 kg/m2 and BMI ≤ 40 kg/m2~   "
56407|NCT02828644|"~     This is an exploratory study to assess potential maintenance of clinical benefit (cognition~     and symptoms) following 4 weeks of at-home digital therapy in ADHD children.~   "
56408|NCT02828631|"~     Videolaryngoscope provide better view of the larynx. This better view could improve the~     navigation of endotracheal tube in nasotracheal intubation. Contrast to the improved result~     in adult, one previous report using Glidescope in children did not show better performance~     than direct laryngoscope. The aim of this study is to compare the performance of McGrath,~     Pentax and Macintosh laryngoscope for nasotracheal intubation in children.~   "
56409|NCT02828618|"~     This study consists of three parts, whereas Part 1 and Part 2 are performed in Germany only,~     and Part 3 is a multinational trial.~      All patients with suspicion of advanced ovarian cancer are detected in the participating~     study centers in a pre-screening. The study centers will register all patients with suspected~     ovarian cancer in a screening log. After the patients have given informed consent, they can~     be enrolled in different parts of the study.~      TRUST-Trial: This part compares two strategies in the therapy of advanced ovarian cancer. En~     detail, this part of the trial will evaluate if one of two strategies of timing surgery~     within the therapeutic procedures may show any significant advances in terms of overall~     survival over the other.~   "
56410|NCT02828605|"~     The purpose of this study is to test a tablet-based application called VIP Transplant,~     devised to improve the recovery experience of patients that have recently had organ~     transplant surgery. The study will consist of two non-randomized arms: the first arm will~     consist of usual care and the second will be using the newly developed app for 21 days to~     replace their in-person visits. Using questionnaires and in-app usage metrics, the research~     team will track whether patients have a better medical outcome, greater patient satisfaction~     with care, and greater compliance rates as compared to patients who do not use VIP Transplant~     to manage their care.~   "
56491|NCT02827552|"~     This study aims to explore prospectively the distribution of individual radiosensitivity in~     the pediatric population and to determine the predictive power of individual radiosensitivity~     biomarkers from an immunofluorescence technique on primary dermal fibroblasts~   "
56411|NCT02828592|"~     Severe aplastic anemia is a rare and serious form of bone marrow failure related to an~     immune-mediated mechanism that results in severe pancytopenia and high risk for infections~     and bleeding. Patients with matched sibling donors for transplantation have a 80-90% chance~     of survival; however, a response rate with just immunosuppression for those patients lacking~     suitable HLA-matched related siblings is only 60%. With immunosuppression, only 1/3 of~     patients are cured, 1/3 are dependent on long term immunosuppression, and the other 1/3~     relapse or develop a clonal disorder. Recent studies have shown that using a haploidentical~     donor for transplantation has good response rates and significantly lower rates of acute and~     chronic GVHD.~   "
56412|NCT02828579|"~     Up to 300 million people have a BMI over 30kg/m2. Obesity is the cause of many serious~     diseases, such as type 2 diabetes, hypertension and NAFLD. Bariatric surgery is the only~     effective method of achieving weight loss in patients with morbid obesity.~      The aim of the study is to assess the impact of bariatric surgery on non-alcoholic fatty~     liver disease in patients operated on due to morbid obesity.~   "
56413|NCT02828566|"~     This study will examine the effectiveness of intranasal (IN) ketamine compared to standard~     intravenous (IV) ketamine administration for simple reductions of orthopaedic injuries in the~     paediatric population. The aim is to assess if IN administration is equivalent to the current~     standard of care, IV. The population to be studied is children 4-17 years of age who require~     a simple orthopaedic reduction. Following a double dummy approach to overcome the difficulty~     in masking interventions, each participant will receive both IV and IN interventions, only~     one of which will be the real drug. Procedural sedation and analgesia (PSA) will be assessed~     using the Dartmouth Operative Conditions Scale (DOCS).~   "
56414|NCT02828553|"~     There is an overwhelming amount of deconditioning that occurs during the hospitalization to a~     patient admitted with a primary diagnosis of congestive heart failure. The goals of this~     study are to determine if monitored activity and aggressive mobility provides improved~     outcomes in hospitalized heart failure patients.~   "
56415|NCT02828540|"~     To assess the efficacy and to evaluate safety of HT047 in patients with acute ischemic stroke~   "
56416|NCT02828527|"~     Background / Rationale at. The mild head injury.~      In France, the incidence of head injuries is estimated at 100,000 per year in France. 80% of~     mild head trauma. This is a pattern of frequent use of the health system. The reason for~     consultation, benign appearance, present a significant risk of complication. In 15 to 25% of~     the evolution of head injury is unfavorable. Disorders of attention, memory disorders,~     psychiatric events and mood changes may occur. These symptoms are grouped into a syndrome,~     post-concussion syndrome.~      The post-concussion syndrome:~      It affects approximately 20,000 people per year in France. This is a common disease and most~     undervalued in the general population. diagnostic criteria post-concussional disorder~     according to DSM-IV (Diagnostic and Statistical Manual). Symptoms may persist for more than 3~     months after head injury. This syndrome is responsible for suffering, personal and~     professional sound and quality of life of patients. It is particularly debilitating in~     everyday life, and can have disastrous consequences on their family, social, cultural and~     professional. It gives rise to many financial implications with compensation requirements and~     expertise consultations.~      Intention of work In a recent study by a team of neuropsychologists Kremlin Bicetre, it has~     been shown that screening and early treatment of post-concussion syndrome from the slight~     head injury prevents chronicity of symptoms.~   "
56417|NCT02828514|"~     The purpose of this study is to determine nasal resonance change after endoscopic endonasal~     transsphenoidal skull base surgery. Furthermore, the quality of voice is assessed, also.~   "
56418|NCT02828501|"~     Physical therapists frequently use spinal manipulation therapy (SMT) to treat spinal pain.~     However, the methods by which SMT exerts its effects are not well understood. The aim of this~     study is to assess potential changes in pain pressure threshold following both a cervical and~     lumbar spine manipulation in a single treatment session at sites local and diffuse to the~     site of manipulation application. This study will also attempt to determine if the order of~     the cervical and lumbar manipulation application impacts pain pressure threshold changes.~   "
56419|NCT02828488|"~     Fragility, geriatric concept recent identification is defined by simple physical indicators.~     The literature suggests that it is related to the risk of hospitalization, falls,~     institutionalization and death. Some studies have shown a link with heart disease, including~     heart failure. The link with the TIA (transient ischemic attack) has however never been~     studied. A fortiori, the impact of the fragility of the risk of recurrent stroke after TIA is~     unknown.~      Several questions need to be asked: Among older patients hospitalized for TIA, what~     proportion of those completing the criteria of frailty? In this same population, is there a~     correlation between fragility and scores ABCD2 score itself predictive of the risk of~     subsequent ischemic stroke? In other words, fragile subjects who have a TIA Have a higher~     risk of ischemic stroke (which could cause a strengthening of prevention measures)?~   "
56420|NCT02828475|"~     This is a pilot study of surgical patients whose postoperative care will be augmented with a~     personalized risk prediction platform (CALYPSO app).~   "
56428|NCT02828371|"~     Verticalization was reported to improve the level of arousal and awareness in patients with~     severe acquired brain injury (ABI) and to be safe in ICU. The investigators evaluated the~     effectiveness of a very early stepping verticalization protocol on the functional and~     neurological outcome of patients affected by disorder of consciousness due to ABI.~      Consecutive patients with Vegetative State or Minimally Conscious State were enrolled in ICU~     on the third day after an ABI. They were randomized to undergo conventional physiotherapy~     alone or associated to fifteen 30-minute sessions of verticalization, using a tilt table with~     robotic stepping device. Once stabilized, patients were transferred to a Neurorehabilitation~     unit for an individualized treatment. Outcome measures were assessed on the third day from~     the injury (T0), at ICU discharge (T1) and at Rehab discharge (T2).~   "
56492|NCT02827539|"~     The purpose of this study is to gather information comparing LessRay Enhanced fluoroscopy~     with the current standard of fluoroscopy. This research is being conducted to demonstrate the~     utility and effectiveness of LessRay Enhanced fluoroscopy during surgical placement of a~     spinal cord stimulator epidural array.~   "
58054|NCT02807038|"~     A single group of pregnant women who was analyzed in the first and in the third trimesters of~     pregnancy~   "
56421|NCT02828462|"~     The emergence of oral delivery in cancer therapeutics is expected to result in an increased~     need for better coordination between all treatment stakeholders, mainly to ensure adequate~     treatment delivery to the patient. There is significant interest in the nurse navigation~     program's potential to improve transitions of care by improving communication between~     treatment stakeholders and by providing personalized organizational assistance to patients.~     The use of health information technology is another strategy aimed at improving cancer care~     coordination that can be combined with the NN program to improve remote patient follow-up.~     However, the potential of these two strategies combined to improve oral treatment delivery is~     limited by a lack of rigorous evidence of actual impact.~      The investigators are conducting a large scale randomized controlled trial designed to assess~     the impact of a navigation program denoted CAPRI that is based on two Nurse Navigators and a~     web portal ensuring coordination between community and hospital as well as between patients~     and navigators, versus routine delivery of oral anticancer therapy. The primary research aim~     is to assess the impact of the program on treatment delivery for patients with metastatic~     cancer, as measured by Relative Dose Intensity. The trial involves a number of other~     outcomes, including toxic side effects, patient quality of life and patient experience . An~     economic evaluation adopting a societal perspective will be conducted, in order to estimate~     those health care resources' used. A parallel process evaluation will be conducted to~     describe implementation of the intervention~   "
56422|NCT02828449|"~     Therapeutic education is an effective way to support the prescription of oral chemotherapy in~     oncology. It aims to increase adherence to treatment, to better control the side effects and~     reduce unplanned readmissions. The three major oncology institutions in the Rhône-Alpes~     region (Hospices Civils de Lyon, the Centre Léon Bérard Cancer Institute and Lucien Neuwirth)~     decided to collaborate on a project to implement an adapted Therapeutic Education Program~     context of each of these institutions.~      The objective of this study is to evaluate the implementation of the intervention in the 3~     participating centers, over 1 year:~        1. Assess the achievement of the target population~        2. Evaluate the adaptation of intervention in context~        3. Evaluate the effectiveness of the intervention (impact): effectiveness in real life,~          identification of interactions with the environment linked to the center, identification~          of unintended effects of the intervention.~        4. Assessing the sustainability of the intervention~   "
56423|NCT02828436|"~     To investigate the exercise blood pressure response during a lower-extremity dynamic exercise~     in postmenopausal women with hypertension and to determine if lumbar epidural spinal cord~     stimulation reduces blood pressure during exercise in postmenopausal women and men with~     hypertension.~   "
56424|NCT02828423|"~     Background: The use of Enamel Matrix Derivative (EMD) when dealing with non-contained defects~     may be limited, as EMD does not maintain a space itself. It has been proposed the use of~     combined therapy, using a bone graft in combination with EMD to avoid the collapse of the~     flap into the bony defect during the healing time. Therefore the aim of this study is to~     evaluate the clinical and radiological healing response of non-contained infrabony defects~     following treatment with a combination of EMD and Biphasic calcium phosphate (BC) or EMD~     alone.~      Methods: Fifty-two patients with at least 1 infrabony defect > 3mm in depth with a probing~     pocket depth ≥ 6mm were randomly treated with EMD/BC or EMD alone. Clinical and radiographic~     parameters were evaluated at baseline, 6 and 12 months after surgery. To standardize the~     procedure an acrylic stent and a millimetre radiographic grid were used. The primary outcome~     was the change in clinical attachment level (CAL).~      Results: Analysis of the data demonstrated a statistically significant difference from~     baseline within each group (p<0.05), showing a difference in clinical and radiographic~     parameters at 6 and 12 months for both EMD/BC and EMD alone. However, there were no~     statistically significant differences between treatment groups.~      Conclusions: It was concluded that the treatment of non-contained infrabony defects with EMD,~     with or without BC, resulted in statistically significant better results after 12 months when~     compared to baseline measurements. In contrast, the combined approach did not result in a~     statistically significant improvement.~   "
56425|NCT02828410|"~     This is an open label trial to test the hypothesize that serum bovine immunoglobulin protein~     isolate (SBI) will improve the nutritional status and quality of life (QOL) of patients with~     an ileal pouch anal anastomosis (IPAA) and symptoms of pouchitis. Subjects with symptomatic~     IPAA will receive two packets of EnteraGam twice daily (total daily dose of 20 g SBI) for up~     to 24 weeks. The primary objective of this study is to determine whether SBI therapy leads to~     improved nutritional status and QOL. A secondary objective is to evaluate SBI in the~     management of their disease, including impact on clinical symptoms.~   "
56426|NCT02828397|"~     Primary Objective: Determine blood concentrations of two formulations of REGN2222~      Secondary Objective: Assess safety and tolerability of REGN2222~   "
56427|NCT02828384|"~     Background:~      Fecal incontinence (FI) is a common complaint, and is often associated with diarrhea and~     urgency. Foods that are high in fermentable oligo-, di-, and mono-saccharides and polyols~     (FODMAPs) cause symptoms of diarrhea and urgency. Thus, assessing the impact of a low FODMAP~     diet in FI patients is needed.~      Aims:~        1. Compare the treatment response with a low FODMAP vs. psyllium based on number of~          episodes in patients with FI.~        2. Compare the efficacy of a low FODMAP diet vs. psyllium in patients with FI on~          pre-specified clinical and quality of life endpoints.~      Methods:~      This is a prospective, randomized control trial of adults meeting the Rome III criteria for~     FI and at least 1 episode of FI due to loose stool per week. After a 2 week screening period~     and randomization, during which the severity of symptoms will be assessed and eligibility~     determined, patients will be randomized to psyllium vs. low FODMAP diet for 4 weeks. A total~     of 20 patients will be recruited for each arm.~      The primary endpoint will be treatment response based on number of incontinence episodes. A~     treatment response is defined as a reduction in the number of FI episodes/week.~   "
56461|NCT02827942|"~     Patients infected with H. pylori were randomly assigned to the dual therapy with vonoprazan~     20 mg bid and amoxicillin 500 mg tid for 1 week or the triple therapy with vonoprazan 20 mg~     bid, amoxicillin 750 mg bid and clarithromycin 200 mg or metronidazole 250 mg bid bid for 1~     week. Success or failure of eradication was determined by the 13C-urea breath test performed~     at 1 month after the therapy.~   "
65623|NCT02708043|"~     The current study retrospectively assesses laryngeal mask airway use during pediatric~     adenoidectomies in terms of patient safety, comfort, complications and surgeon satisfaction~     levels.~   "
56429|NCT02828358|"~     This pilot phase II trial studies the side effects of azacitidine and combination~     chemotherapy in infants with acute lymphoblastic leukemia and KMT2A gene rearrangement. Drugs~     used in chemotherapy, such as methotrexate, prednisolone, daunorubicin hydrochloride,~     cytarabine, dexamethasone, vincristine sulfate, pegaspargase, hydrocortisone sodium~     succinate, azacitidine, cyclophosphamide, mercaptopurine, leucovorin calcium, and thioguanine~     work in different ways to stop the growth of cancer cells, either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading. Giving more than one drug~     may kill more cancer cells.~   "
56430|NCT02828345|"~     This research trial studies the levels of a type of biomarker, circulating tumor cells~     (CTCs), in the blood of patients with stage I-IV melanoma. A biomarker is a biological~     molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal~     process, or of a condition or disease. A biomarker may be used to see how well the body~     responds to a treatment for a disease or condition. Studying samples of blood in the~     laboratory obtained before and after treatment from patients with melanoma may help doctors~     learn more about changes that occur in CTC levels and whether they may predict how well~     patients will respond to therapy.~   "
56431|NCT02828332|"~     Epidemiological studies have shown that a wide range of outcome trajectories exist in ASD,~     but little is known about their determinant in a long-term perspective. The EpiTED cohort was~     set-up in order to understand the heterogeneity of developmental trajectories among children~     with a diagnosis of PDD and the role of clinical, biological and environmental factors in~     their adaptive outcome. It is one of the rare cohorts involving a long term prospective~     follow-up based on a large set of variables, and precise phenotypes of the entire autism~     spectrum.~   "
56432|NCT02828319|"~     To confirm the safety and efficacy of Z-213 until 12 weeks after start of Z-213~     administration in patients with iron deficiency Anemia~   "
56433|NCT02828306|"~     Patients with skull defects after craniotomy for example tumor resection, head trauma,~     stroke, need a reimplantation of the bone afterwards. For some circumstances, their own bone~     cannot be reimplanted due to infection, tumor infiltration, damage to the bone, or aseptic~     bone necrosis. In these cases a Patient Specific Implant (PSI) needs to be designed to fit~     into the patient`s skull defect.~      The design of the PSI is based on the preoperative CT-scan of the patient`s head with the~     skull defect, the imaging data set is uploaded and processed with IPlanNet software by~     BrainLab®. With the help of the software, a 3D model of a negative mould of the PSI is~     designed and printed. In the operation room, the PSI is fabricated under sterile conditions~     using the PSI mould. The design of the PSI mould with the help of IPlanNet is demanding and~     takes some few hours depending on the complexity of the case to be designed. In certain cases~     the accuracy of the fabricated PSI mould is not optimal, so that the surgeon intraoperatively~     has to adapt for the inaccuracy to achieve the best cosmetic and functional results at the~     expense of the operation duration, a known risk factor for postoperative wound infection and~     other perioperative complications.~      Therefore, the investigators have developed an automated computer-based algorithm for PSI~     design (CAPSID). With the help of this tool, an accurate PSI and its corresponding mould can~     be calculated and designed based on the preoperative CT scan of the patient within 5-15~     minutes and the corresponding mould can be printed. This step is automated and thus,~     independent of the neurosurgeons experience and skills in 3D processing software. The mould~     can be used for intraoperative fabrication of the implant under sterile conditions in the~     common way as described above. The possible advantages of the clinical establishment of this~     procedure would be a higher accuracy of the PSI compared to the conventional PSI fabrication~     method with better cosmetic results, lower costs and faster availability and production~     leading to shorter waiting time for the patient, and as a consequence of the higher accuracy~     leading to shorter operation time, with a reduction of risk of operative adverse events for~     the patient. Furthermore, the proof of practicability of this new method, could lead to new~     concepts in the field of Computer-based Patient Specific Implants in modern medicine in~     general.~   "
56434|NCT02828293|"~     The objective of this research project is to perform a comparative study on the in vivo~     kinematics of the GMK Sphere prosthesis in comparison to the conventional GMK PS Fixed~     Bearing TKA and the GMK UC Fixed Bearing TKA.~   "
56435|NCT02828280|"~     The direct objective of this study is to determine whether an experienced provider can more~     adequately and/or easily ventilate an anesthetized patient with the NuMask device as compared~     to traditional bag-valve-mask ventilation. These are approved masks, being used in the~     patients routine care. The researchers believe that mean tidal volumes obtained by~     experienced providers when manually ventilating anesthetized patients with the NuMask device~     will be larger than when using the traditional bag-valve-mask.~   "
56436|NCT02828267|"~     A brief negotiational interview (BNI), administered in an Emergency Department setting for~     both hazardous and harmful drinkers has been shown to cost-effectively reduce a patient's~     alcohol intake and re-injury rate up to 3 years post intervention. A BNI is a short (5-60~     minute) counseling session administered by non-addiction specialists based on the concepts of~     the FRAMES model of motivational interviewing. The investigators will conduct a pilot study~     to test the feasibility of the study protocols, acceptance of the intervention, and patient~     enrollment and retention rates, as we prepare for a fully powered randomized controlled trial~     of the intervention for patients seen at the Kilimanjaro Christian Medical Center (KCMC)~     Emergency Department.(ED)~   "
56437|NCT02828254|"~     The purpose of this study To evaluate the safety and efficacy of PRI-724 administration in~     patients with cirrhosis due to hepatitis C by 12-month follow-up.~   "
56438|NCT02828241|"~     The purpose of this exploratory study is to assess the efficacy, safety and tolerability of~     DFD-04 Ointment for topical treatment of rosacea over 12 weeks of treatment.~   "
56439|NCT02828228|"~     1. Analyze the influence of vitamin D supplementation in obese children during weight-loss~          program on BMI, body composition and bone mineral density.~        2. Analyze the influence of vitamin D supplementation on the risk profile of~          obesity-related complications, namely impaired tolerance of glucose, insulin resistance,~          dyslipidemia and arterial hypertension, in obese children participating in weight-loss~          program.~        3. Analyze the prevalence of vitamin D deficiency among obese children.~        4. Analyze the risk factors of vitamin D deficiency in obese children (age, gender,~          pubertal status).~   "
56440|NCT02828215|"~     The objectives of this study include using the new technology of SS-OCT (swept source optical~     coherence tomography) to evaluate morphological abnormalities of the vitreous, retina and~     choroid and to assess the repeatability of retinal and choroidal thickness measurements in~     retinal disease using SS-OCT. A secondary objective is to use the new imaging modality of~     adaptive optics to directly visualize photoreceptor mosaics and microvasculature in eyes with~     retinal and choroidal disease.~   "
56462|NCT02827929|"~     The objective of this study is to determine whether the systematic education on air way~     disease and inhalers in outpatient settings contributes to improve the quality of life.~      Education has been known to be effective for management of chronic airway disease. However,~     the real benefits remain unclear. An organized education on the chronic airway disease is~     directed by primary care physicians, and the investigators evaluate the effectiveness of the~     education.~   "
56441|NCT02828202|"~     Prevention of melanoma can be efficient but mortality remains unchanged and 15 to 20% of~     patients still die from melanoma. Indeed metastatic melanoma is a heterogeneous highly and~     multiple mutations driven cancer. Significant survival benefit was demonstrated since 2011~     with anti-CTLA4, programmed death-1 (anti PD1) antibodies, B-Raf proto-oncogene,~     serine/threonine kinase (BRAF) and MAP-ERK kinase (MEK) inhibitors. Future improvement of~     advanced melanoma prognosis will rely on clinico-epidemiological studies and on biological~     studies aiming to validate and identify new prognostic and predictive factors based upon~     clinico-epidemiological and histological data, genomic host and tumor alterations, tumor~     microenvironment characteristics, individual immunological profile and functional imaging. In~     the context of marketing of costly innovative molecules prospective collection of economic~     data on treatment and toxicity are required. Large biobanks collecting data from cohorts of~     advanced melanoma are mandatory for such projects.~      MELBASE is a French prospective national cohort enrolling advanced melanoma patients whose~     objectives are :~        -  To provide an annual instrument panel with a descriptive and correlative analysis of~          patients with advanced melanoma in France including epidemiological, clinical and~          biological socio-economic characteristics~        -  to validate and identify new clinical, epidemiological, and biological prognostic~          factors such as genomic host and tumor alterations, tumor microenvironment~          characteristics, individual immunological profile in advanced melanoma.~        -  to evaluate the risk-benefit, the impact on treatment on patient quality of life, the~          management cost of patients treated with the validated and future treatments of~          metastatic melanoma. The project also aims to define predictive biomarkers of response~          and toxicity including pharmacogenetics and tumor genetics alterations, tumor~          microenvironment characteristics, individual immunological profile.~      Patients with unresectable stage III or stage IV melanoma will be enrolled prospectively for~     1 year with a 5 years follow-up (a total of 2000 patients will be enrolled) from 26 French~     centers A database of clinical monitoring of metastatic patients will be established and~     associated with a virtual tumor bank. This national database will be issued from the use of~     biological, clinical and imaging databases already available in the centers and optimized for~     this project; this database will also results from the interaction with the French national~     cancer institute (INCa) genotyping platform.~   "
56442|NCT02828189|"~     The main objective of this study is to determine whether the proposed program of therapeutic~     exercise is effective in improving fatigue and quality of life, more than the exercise~     unsupervised depending on their preferences, in women treated for breast cancer.~   "
56443|NCT02828176|"~     The aim of the study is to investigate the effect of different angles of lateral tilt on the~     maternal hemodynamics before and after spinal anesthesia~   "
56444|NCT02828163|"~     Comparing the effect of injecting autologous platelet rich plasma and triamcinolone acetonide~     in the erosions of buccal mucosa of pemphigus vulgaris patients.~   "
56445|NCT02828150|"~     Although it is demonstrated that nutritional support can improve clinical outcomes, the~     literature shows that approximately 50% of cancer patients are not able to meet their~     estimated energy requirements. Recent clinical studies suggest that a supplementary support~     for parenteral nutrition (PN) could significantly help to improve the nutritional status of~     malnourished cancer patients.~      International guidelines recommend the use of PN in malnourished, hypophagic, non-surgical~     cancer patients if enteral nutrition is not feasible and in patients affected by severe~     iatrogenic gastrointestinal complications and in whom inadequate food intake is anticipated~     for more than 7 days. However, there are no studies on the effects of integrative PN in~     hospitalized, malnourished, hypophagic, non-surgical cancer patients.~      Recent studies have reported on the validity of bioelectrical impedance vector analysis in~     monitoring the body composition of patients receiving nutritional support. Particularly,~     phase angle proved to be a superior prognostic marker than other nutritional screening tools.~   "
56446|NCT02828137|"~     The neutrophil-to-lymphocyte ratio (NLR) has been proven to be reliable inflammatory marker~     for atherosclerotic process and predictor for clinical outcomes in patients with various~     cardiovascular diseases. Recent study reported elevated NLR was associated with impaired~     myocardial perfusion in ST-segment elevation myocardial infarction (STEMI) patients. The~     investigators sought to determine whether NLR is associated with coronary microcirculation~     assessed by index of microcirculatory resistance (IMR) in STEMI patients who undergone~     primary percutaneous coronary intervention (PCI). A total of 123 patients with STEMI~     underwent successful primary PCI were consecutively enrolled. NLR at admission was~     calculated, and the patients were divided into three groups according to NLR tertiles. IMR~     was measured by intracoronary thermodilution-derived method immediately after index PCI.~   "
56447|NCT02828124|"~     The purpose of this study is to evaluate the safety and tolerability of BMS-986183 in~     patients with liver cancer.~   "
56448|NCT02828111|"~     This is a double-blind, dose escalating, randomized, vehicle-controlled study designed to~     compare the efficacy and safety of patidegib gel 2% and 4% applied once or twice daily in~     comparison with that of vehicle in patients with Basal Cell Carcinoma. One investigational~     center (metasite) in the United States will participate in this study. Approximately 36~     subjects who meet the study entry criteria will be enrolled into one of four sequential~     cohorts. Within each cohort subjects will be randomized in a 2:1 ratio to receive active or~     vehicle gel.~   "
56449|NCT02828098|"~     Part 1: 16 to 32 patients with aggressive solid tumors from whom biopsies can be obtained,~     will receive BO-112 through IT administration.~      Injected lesions must be palpable and biopsiable at the time of injection, and biopsied after~     7-14 days. Patients will not receive an alternative therapy during the period comprising from~     first and second biopsy. BO-112 will be administered at a starting dose. Upon confirmation of~     the safety profile of the starting dose and evaluation of the pharmacokinetic (PK) profile,~     three additional dose levels are expected to be tested.~      During the course of the study, subjects will be examined for any side effects that may occur~     (safety and tolerability).~      Additionally this study will also study BO-112 biological activity, the innate and adaptive~     immune system response and signaling pathways, as well as signs of clinical relevance, will~     be studied.~      Part 2: An additional 12 patients with progressive disease while on anti-PD1 treatment for an~     approved indication, will receive BO-112 through IT administration in combination with the~     anti-PD1 treatment to evaluate the safety and tolerability of the combination.~      Injected lesions must be palpable and biopsiable at the time of injection. Patients will~     continue with their anti-PD1 treatment. During the course of the study, patients will be~     examined for any side effects that may occur (safety and tolerability).~      Additionally this part of the trial will also study BO-112 biological activity, the innate~     and adaptive immune system response and signaling pathways, as well as signs of clinical~     response~   "
56486|NCT02827617|"~     The general aim of the project is the identification of dynamic molecular markers that can~     help the early and real time prediction of sustained benefit or no benefit from ibrutinib~     treatment in CLL harboring TP53 mutations. Specific aims of the project include: 1) Assess~     whether clearance of TP53 mutated clones translates into a predictive biomarker of long term~     benefit from ibrutinib treatment in CLL. 2) Assess whether plasma cell free DNA represents a~     sensitive tool that can early and dynamically inform on the development of ibrutinib~     resistant mutations in CLL.~   "
56450|NCT02828085|"~     Pericardial syndrome includes pericardites acute pericardial effusion and cardiac tamponade,~     recurrent pericarditis squeezing chronic pericarditis. The etiologies are very numerous and~     can be classified as infectious, neoplastic, metabolic or systemic, toxic causes. Diagnosis~     is difficult, and 80% of etiologies remain classified idiopathic. In their laboratory to~     improve the diagnosis of this syndrome investigators have developed a strategy of systematic~     prescription of biological tests by kit. This prescription by 'kit' strategy proved its~     interest by comparison with an intuitive requirement of biological. In this study~     investigators want to improve the diagnostic causative of pericarditis by implementing a new~     diagnostic strategy. This new strategy includes (i) samples additional less invasive for the~     patient, the swab pharyngeal and nasal, (ii) the addition of at the outset of more effective~     diagnostic techniques: specific Polymerase Chain Reaction (PCR)~   "
56451|NCT02828072|"~     The effects of Sudarshan Kriya Yoga (SKY) on autonomic function in patients with~     anxiety-depression disorders is unknown. Thus, the authors will investigate cardiac autonomic~     control in a population of patients with anxiety-depression disorders which will undergo a~     specific SKY treatment.~   "
56452|NCT02828059|"~     A medical approach that warrants continuous and reliable local administration of non-opioid~     analgesic drugs might substantially improve post-surgery pain management in CS, while~     decreasing the necessity of staff-dependent invasive procedures and the probability of~     untoward effects following systemic drug exposure. ReadyfusOR® is a formulation comprising a~     Ropivacain-loaded single-use pump which has been approved for regional application of the~     analgesic drug, also comprising obstetric interventions. There is, however, scarce scientific~     information on the efficacy and benefit of this anesthetic drug formulation for pain~     management following CS by means of continuous wound infiltration.~   "
56453|NCT02828046|"~     The purpose of this study is to evaluate safety, tolerability, and PK/PD of M281 after single~     and multiple doses in healthy volunteers.~   "
56454|NCT02828033|"~     This study is an open label proof of concept study of rilonacept for patients with ANSHL~   "
56455|NCT02828020|"~     This study will evaluate the efficacy, safety, and tolerability of 2 doses of ubrogepant (50~     and 100 mg) compared to placebo for the acute treatment of a single migraine attack.~   "
56456|NCT02828007|"~     Patients with severe respiratory diseases such as chronic obstructive pulmonary disease~     (COPD) or obesity-hypoventilation syndrome (OHS) can benefit from having non-invasive~     ventilation (NIV). Non-invasive ventilation consists of a machine (ventilator) that is~     blowing air through a mask. NIV provides patients with a bigger expansion of their lung when~     they are breathing. This better expansion helps patients to have more oxygen and less waste~     gas (or carbon dioxide) in their body.~      These improvements enhance survival and quality of life. In order to provide appropriate~     ventilation for each patient, the ventilator can generate different types of blowing:~        -  Continuous positive airway pressure (CPAP) which delivers a constant pressure to the~          mask~        -  Pressure support ventilation (PSV) which delivers a constant pressure to the mask and,~          on top of that, delivers more pressure when the patient begins to breathe in.~        -  Pressure control ventilation (PCV), which is similar to PSV, but use a fixed time to~          generate the flow when the patient begins to breathe in.~      These different types of blowing have consequences on patient comfort as well as on the~     improvement of their ventilation.~      To assess the improvement of the ventilation, the investigators currently use blood tests,~     however, these reflect overall output and may miss more subtle changes in breathing that~     could affect how patients feel.~      Electrical impedance tomography (EIT) is a new technology that involves wearing a belt of~     sensors around the chest that provides information on how well the lungs are being filled~     with air by the ventilator. It allows a non-invasive assessment of the effect of NIV onto~     lung ventilation in real-time.~      The investigators hope to use the EIT technology to assess in real-time patients lung~     ventilation when they are using the NIV. The investigators hope that EIT will provide them~     with information on which type of blowing is more effective and more comfortable than the~     others.~   "
56457|NCT02827994|"~     This study compared the effectiveness of pain neurophysiology education and neck/shoulder~     exercises with no intervention in adolescents with chronic idiopathic neck pain (CINP).~   "
56458|NCT02827981|"~     Active discopathies or MODIC 1, are a diagnostic entity discovery with the contribution of~     MRI in which the first cases were described by Dr. Michael MODIC in 1988. It is characterized~     by a vertebral bone edema secondary to active discarthrose. Its prevalence is estimated at 6%~     of the general population and up to 40% of the CLBP according to studies. Following the~     discovery of this recent diagnostic entity, responsible for low back pain, the question of~     its management is debate in the medical community. Early studies demonstrate the~     effectiveness of corticosteroid injections in intra-disc. Other works, most recent, suggest~     the contrary, infectious, incriminating a pathogenic role of certain bacteria such as~     Propionibacterium acness or Corynebacterium propinquum recommending, in contrast, treatment~     with prolonged antibiotic therapy. This study will aim to assess the effectiveness of~     intra-disc infiltration GHPSJ carried out between 2007 and 2014. The innovation of our work~     will be to assess these infiltrations in various subgroups such as patients with a previous~     surgery of the spine or a history of scoliosis or spondylolisthesis.~   "
56459|NCT02827968|"~     This is an open label, dose escalation study to evaluate the safety and tolerability of KN035~     in advanced and metastatic solid tumor.~   "
56460|NCT02827955|"~     Essential tremor (ET) is the most frequent movement disorder. Its prevalence is about 1/200~     implying that at least 300 000 peoples are concerned in France. Its frequency increase with~     age (14% of patients 65 yo). The diagnostic criteria are postural and kinetic tremor that can~     be associated with head/voice tremor. ET induces a social impairment but also difficulties to~     perform any task requiring dexterity. With time, tremor can be so severe that every activity~     of daily living is impaired with loss of autonomy.~      Treatment such as betablockers, primidone or antiepileptics might have some efficacy at the~     beginning. But as the severity of the tremor increases, there is lack of efficacy. Deep Brain~     stimulation (DBS) of the ventral intermediate nucleus (VIM) of the thalamus can be proposed.~     However, in case of medical or surgical contra-indication, Gamma Knife (GK) radiosurgery~     thalamotomy can be an alternative option.~      Patients will be included with a minimum of 12 months after having the first thalamotomy~     (Gamma Knife 1) (done on the most annoying side) subject to no significant deterioration in~     cognitive assessment, voice assessment and balance and postural assessment or~     neuroradiological abnormality.~      Patients will be assessed with Magnetic resonance imaging (MRI) cerebral, clinical assessment~     (tremor rating scale) impairment of activity of daily living, neuropsychological evaluation,~     voice assessment and balance and postural assessment.~      The second thalamotomy (Gamma Knife 2) will be proposed and a monitoring at M6 and M12 will~     be done.~      This study will demonstrate the feasibility and tolerance of bilateral GK radiosurgery~     thalamotomy in ET patients with severe impairment.~   "
62632|NCT02747082|"~     The aim of this randomized clinical trial is to compare the antibacterial effects of 1%~     sodium hypochlorite (NaOCl) and 2% chlorhexidine gluconate (CHX) during retreatment of teeth~     with apical periodontitis (AP).~   "
56463|NCT02827916|"~     Oxaliplatin is an anticancer agent commonly used in the treatment of colorectal cancer.~     However, the development of neuropathic pain under treatment limits its use. These are~     manifested by acute hyperesthesia / distal cold allodynia and chronic course of hypoesthesia.~      It is widely reported that these pains are consecutive to hyperexcitability of some ioniques2~     channels (mainly sodium and potassium channels). However, the pathophysiological mechanisms~     of neurotoxicity are multifactorial and still imperfectly described.~      Since May 2014, the hospital group Paris Saint Joseph led the pilot study LIPIDOXA whose~     challenge is to quantify / measure NAION and explained by a biochemical approach,~     specifically Lipidomics. The CANALOXA study is the logical continuation of LIPIDOXA study~     insofar design methodology relies heavily on techniques developed for LIPIDOXA study and that~     the expected results will be complementary to those of LIPIDOXA.~   "
56464|NCT02827903|"~     Compare the Efficacy and Safety of Metformin/Rosuvastatin Combination Therapy With Metformin~     or Rosuvastatin Monotherapy in Patients With Type 2 Diabetes and Dyslipidemia~   "
56465|NCT02827890|"~     The purpose of this study is to evaluate a pharmacokinetic drug interaction between~     sitagliptin and lobeglitazone in healthy male volunteers.~   "
56466|NCT02827877|"~     This pilot clinical trial studies how well copper Cu64-DOTA-trastuzumab positron emission~     tomography (PET) works in predicting response to treatment with trastuzumab and pertuzumab~     before surgery in patients with human epidermal growth factor receptor 2 (HER2) positive~     breast cancer that has spread from where it started to nearby tissue or lymph nodes.~     Diagnostic procedures, such as copper Cu 64 DOTA-trastuzumab PET, may help predict a~     patient's response to trastuzumab and pertuzumab before surgery in patients with locally~     advanced HER2 positive breast cancer.~   "
56467|NCT02827864|"~     This project is designed to investigate the effects of combining tDCS and MT in patients with~     subacute and chronic stroke. This project is also designed to investigate the optimal~     application timing of tDCS in combination with MT in patients with subacute and chronic~     stroke. Patients with subacute and chronic stroke will be recruited and randomized into one~     of the 3 groups: sequentially apply tDCS and MT group (SEQ), apply tDCS concurrently with MT~     group (CON), and MT with sham tDCS group (SHAM). All participants will receive 40 minutes of~     MT followed by 30 minutes of functional task training. For the participants in the SEQ group,~     20 minutes of tDCS will be applied prior to MT, while tDCS will be applied concurrently with~     MT for the first 20 minutes in the CON group. As for the SHAM group, tDCS electrodes will be~     placed on the scalp without actual current output. The interventions will be carried out 90~     minutes per day, 5 days per week, for 4 weeks. Behavioral outcomes will be assessed by~     blinded evaluators before, after, and 3 months post intervention. To study the possible~     interaction of treatment group and time of outcome evaluations, group (SEQ vs. CON vs. SHAM~     groups) × time (pretest vs. posttest vs. follow-up) repeated measures ANOVA will be~     performed. Additionally, the partial eta square (η2) will be calculated to determine the~     effect size of interest.~   "
56468|NCT02827851|"~     Stromal vascular fraction of cells (SVF) will be extracted from lipoaspirate by enzymatic~     digestion. SVF will be administered in a single dose intraarticularly 4 weeks after~     arthroscopic debridement. All patients will receive cell therapy.This is a single arm study~     with no control.~   "
56469|NCT02827838|"~     This pilot clinical trial studies how well durvalumab before surgery works in treating~     patients with oral cavity or oropharynx cancer. Monoclonal antibodies, such as durvalumab,~     may interfere with the ability of tumor cells to grow and spread.~   "
56470|NCT02827825|"~     The aim of this study is to describe the population of patients admitted to the ICU in~     neurosurgery for stroke requiring secondary care in intensive care and their future.~   "
56471|NCT02827812|"~     Parkinson's disease (PD) is a chronic neurodegenerative disease due to the loss of~     dopaminergic neurons in the substantia nigra, leading to motor symptoms of tremor, rigidity,~     and bradykinesia, as well as an array of non-motor symptoms that affect cognition, sleep,~     behaviour, and the autonomic nervous system.~      Lifelong rehabilitation measures, along with medication treatment, are the major components~     of patient management. Physical exercises positively affect patients' quality of life (QOL)~     and their functional capacities. Poor adherence to rehabilitation, limited patient education,~     and access to specialized care can be barriers to treatment. A number of papers in fact~     report that telemedicine is an acceptable means of care delivery reduces travel burdens and~     may improve patient outcomes. However, most of these studies were not randomized or~     controlled and did not include nursing home patients, who may benefit the most from specialty~     care.~      Moreover, there is no evidence supporting the use of telerehabilitation for physical~     assessments of people with PD. For this reason investigators hypothesize that a home~     telerehabilitation system guiding patients in following their exercise program combined with~     a computerized decision-support tool monitoring patient performance, would be feasible for~     and acceptable to patients with PD and would improve functional status.~   "
56472|NCT02827799|"~     The purpose of this exploratory developmental study is to test the feasibility,~     acceptability, and preliminary efficacy of cognitive behavioral therapy for insomnia (CBT-I)~     among adults who have stable Heart Failure. Participants were randomized either to a~     treatment (CBT-I) or attention-control condition (heart failure self management education).~   "
56473|NCT02827786|"~     A single-centre, industry sponsored, proof-of-concept pilot study to assess the feasibility~     of Electromagnetic Acoustic Imaging (EMA) as an imaging platform in the visualization of~     hepatic tumours.~   "
56474|NCT02827773|"~     The aim of this research project is to compare the use of Talking Pill Bottles to usual~     care in patients who have low functional health literacy and who purchase medications for~     primary hypertension at a retail pharmacy with regard to:~        1. feasibility of the procedures,~        2. utility of the equipment,~        3. medication adherence,~        4. self efficacy in medication self management, and~        5. blood pressure control.~   "
56487|NCT02827604|"~     This prospective, clinical, observational study compares preoperative and intraoperative~     sonographic assessment of lower uterine segment of women who underwent ≥ second cesarean~     section.~      It is the purpose of the study to assess transabdominal (linear/convex ultrasound probe) and~     transvaginal approach versus intraoperative sonographic assessment of lower uterine segment.~   "
64340|NCT02724800|"~     The purpose of this study is to directly compare the effectiveness of two interventions for~     insomnia: Brief Behavioral Treatment for Insomnia (BBTI) vs. Cognitive Behavioral Therapy for~     Insomnia (CBTI).~   "
56475|NCT02827760|"~     The composition and metabolism of human gut microbiota play crucial roles in health.~     Microbial colonisation of the gastrointestinal tract varies widely, with the large intestine~     having not only the highest density of microbes in terms of bacterial cells per gram but also~     the most metabolically active microbial community. Genetics, mode of birth, infant feeding~     patterns, antibiotic usage, sanitary living conditions and long term dietary habits~     contribute towards shaping the composition of the gut microbiome. Diet clearly has a major~     impact on variation in the gut microbiota composition, and this can be detected in faecal~     samples after only a few days. The bacterial metabolism of dietary components produces much~     chemical diversity in the large intestine with protective or detrimental effects on disease~     development.~      Dietary protein levels are relatively high in western European populations, up to 103g/d, as~     reported by Food and Agriculture Organization. This may result in high levels, entering the~     large gut where it can become a substrate for proteolytic bacteria. Protein specifically can~     provide nutrition for microorganisms but metabolites from bacterial protein breakdown can be~     detrimental. Protein intake from the diet might not be the only source of microbial~     proteolysis; the human body also secretes considerable amounts of protein into the digestive~     lumen which can potentially be used by the microflora. On the contrary, end products of~     carbohydrate metabolism can be positive for health. In this context, prebiotics are~     carbohydrates that are resistant to digestion and can become available for bacteria in the~     colon to produce short chain fatty acids and inhibit the production of harmful metabolites. A~     switch towards more carbohydrate metabolism in the colon, at the expense of proteolysis~     therefore has positive capacity through the production of more benign metabolites.~      Rationale for design Prebiotics are dietary ingredients that target carbohydrate digesting~     bacteria only. Given the high intake levels of protein in Western populations, they may be~     useful to modulate the composition/activity of the microbial gut ecology for improved health.~      Among prebiotic nutrients, inulin-type fructans (ITF) are well characterized and their~     administration promotes growth of beneficial microorganisms like Bifidobacterium spp. .These~     microorganisms are involved in the reduction of intestinal endotoxin concentration, improve~     glucose tolerance, exert benefits upon immune function and inhibit pathogens. In healthy~     individuals, ITF intake promotes satiety and modulates gut peptides regulating food intake.~      The aim of the present study is to investigate the effect of inulin-type fructans (ITF) on~     the negative consequences of colonic fermentation in individuals consuming high protein~     diets. The hypothesis to be tested is that their action promotes carbohydrate degrading~     bacteria at the expense of protein utilisers.~   "
56476|NCT02827747|"~     Keratoconus is the most common primary cornea ectasia, where the cornea undergoes structural~     changes, leading to loss of tissue integrity and vision loss. The prevalence of Keratoconus~     is 1:2000 in the general population. Oxidative stress has been thought to have a major effect~     in the disease pathogenesis of Keratoconus. In vitro studies have shown increase in~     metabolites related to oxidative stress in Keratoconus disease, and that Keratoconus cells~     undergo increased oxidative stress and tissue damage. Animal models have shown a therapeutic~     effect of Vitamin C (ascorbate) in corneal wound healing. Glutathione and Vitamins A, C, and~     E are important antioxidants in the human body. To this date, the role of systemic~     antioxidant supplementation in Keratoconus patients has yet to be studied. In addition, it~     has yet to be established as to whether there is a correlation between serum antioxidant~     levels, and the severity of disease in the Keratoconus patient. The investigators propose to~     investigate the plasma levels of antioxidants in relation to disease severity. The~     investigators will also investigate the role of antioxidant supplementation—consisting of~     parenteral Glutathione (GSH), and Vitamins A, C and E—in delaying the disease progression in~     Keratoconus.~   "
56477|NCT02827734|"~     Current diagnostic tools used in interstitial lung disease (ILD) do not meet the challenges~     set by the complex pathophysiology of this heterogenous group. The investigators therefore~     aimed to evaluate novel or not widely used diagnostic approaches for the detection and~     therapeutic monitoring of patients with various ILDs.~   "
56478|NCT02827721|"~     Current guideline-based criteria defining COPD do not meet the challenges set by the complex~     pathophysiology of the disease. The investigators therefore aimed to evaluate novel or not~     widely used diagnostic approaches for the detection and therapeutic monitoring of COPD.~   "
56479|NCT02827708|"~     This trial is conducted globally. The aim of this trial is to investigate efficacy and safety~     of oral semaglutide versus placebo in subjects with type 2 diabetes and moderate renal~     impairment.~   "
56480|NCT02827695|"~     Investigators will employ a 2-arm Randomized Controlled Trial (RCT) design with the subject~     as the unit of randomization and analysis. Kidney transplant recipients having uncontrolled~     hypertension will be enrolled into a screening phase to measure medication non-adherence.~     Each subject will use an electronic pill tray for 1 month without any reminder functions~     activated. Non-adherent subjects who remain uncontrolled will be randomly assigned to SMASK~     or Standard Care (SC). SC will continue to use the pill tray with reminders turned off and~     will receive attention control texts with healthy lifestyle information. SMASK will have the~     reminder functions of the electronic pill tray activated and will receive a Bluetooth blood~     pressure monitor and an app to collect the data and send to researchers.~      Subjects in the second phase will participate in 4 more evaluations at months 1, 3, 6, 12~     post randomization. Research staff will measure resting blood pressure and heart rate.~   "
56481|NCT02827682|"~     The morbidity of colorectal cancer and the surgery number among elderly is growing. The~     investigators need to provide more advanced and specific monitoring technology for these~     patients. Index of consciousness (IoC) monitor is now widely used among endoscopy,~     cholecystectomy and other common clinical applications. The investigators goal is to verify~     whether using IoC monitor could help to improve the postoperative recovery after colorectal~     surgery.~   "
56482|NCT02827669|"~     The One Drop Experts Program for Type 2 Diabetes Self-Management Impact on A1c trial is a~     12-week long, prospective, intent-to-treat study that aims to evaluate the impact of the One~     Drop app and Experts program on HbA1c levels for individuals with uncontrolled Type 2~     diabetes. A secondary objective will be to evaluate participants who utilize an Apple Watch~     in combination with the One Drop app and Experts program, and assess whether this group is~     more engaged or experiences a different impact as compared to participants who utilized the~     One Drop app and Experts program only.~   "
56483|NCT02827656|"~     The purpose of this study is to compare two luteal support protocols in In vitro~     fertilization patients (IVF) and are at risk of developing ovarian hyperstimulation syndrome~     (OHSS). We would like to determine whether luteal Decapeptyl on days 3, 6,9 post ovulation~     triggering is as good as low dose hCG on day 3 post triggering..~   "
56484|NCT02827643|"~     The purpose of this study is to determine whether calcium and vitamin D supplement can~     attenuate bone loss in HIV-infected-patients in Thailand who receive Tenofovir disoproxil~     fumarate.~   "
56485|NCT02827630|"~     The purpose of this study was to evaluate the efficacy of a new digital health offering,~     Proteus Discover to lower blood pressure and glycated hemoglobin in patients with~     uncontrolled hypertension and type 2 diabetes.~   "
56553|NCT02826746|"~     The primary purpose of this study is to investigate the effect of intravenous magnesium on~     postoperative throat pain after thyroidectomy.~      The secondary purpose of this study is to investigate the effect of intravenous magnesium on~     total dose of fentanyl in recovery room after thyroidectomy.~   "
56493|NCT02827526|"~     Patients undergoing major spinal surgery continue to experience moderate-to-severe pain~     during the first 2-3 days following the operative procedure. Several factors contribute to~     postoperative pain in this patient population. Many patients present to surgery dependent on~     relatively high doses of oral opioids; this daily administration leads to tolerance to the~     effects of these drugs as well as hyperalgesia (exposure to opioids makes subsequent pain~     worse). In addition, surgical procedures on the spine are very painful. Furthermore, most of~     the opioids used after surgery only produce analgesia (pain relief) for 2-4 hours, which~     leads to fluctuations in levels of pain control (patients have to push a button to deliver~     pain medication when they begin to feel discomfort). Recent data suggest that the use of a~     long-acting opioid like methadone in the operating room, which provides analgesia for 24-36~     hours, may improve pain control after spinal fusion surgery. However, other pain treatment~     modalities are required in this patient population. Studies have demonstrated that ketamine,~     a drug that prevents pain by a mechanism different from opioids, is effective in reducing~     pain medication requirements when given in the perioperative period. Small-dose infusions not~     only provide analgesia, but also prevent opioid tolerance and hyperalgesia. In particular,~     the combination of methadone and ketamine may be especially effective in controlling pain in~     patients following major operations. The aim of this randomized clinical trial is to examine~     the effect of a low-dose perioperative infusion of ketamine, when given with methadone in the~     operating room, on postoperative pain medication requirements, pain scores, and clinical~     recovery characteristics after spinal fusion surgery.~   "
56494|NCT02827513|"~     The purpose of this study is to investigate the safety, tolerance, food effect,~     pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple doses of extended~     release (XR) formulations of Centanafadine (CTN) in Young Healthy participants.~   "
56495|NCT02827500|"~     The PRIME-HF study is a multi-center, patient-level, randomized, open-label study of~     approximately 450 patients with reduced (left ventricular ejection fraction) LVEF of ≤ 35%~     and heart-rate ≥70 beats per minute (bpm) who are being discharged from the hospital~     following stabilization from acute heart failure (HF)(primary or secondary) and will be~     randomized to a treatment strategy of predischarge initiation of ivabradine or usual care.~      All participants should have a follow-up visit within 7-14 days of hospital discharge. Heart~     rate and systolic blood pressure will be assessed at this clinical visit. For participants~     randomized to predischarge initiation of ivabradine and on ivabradine 5mg BID, the heart rate~     may be used to adjust the dose the dose to 2.5mg BID or 7.5mg BID. For participants~     randomized to usual care, ivabradine may be initiated at the provider's discretion. All~     participants will have a second follow-up study visit 6 weeks (42 +/- 14 days)~     post-discharge. Heart rate, systolic blood pressure and quality of life (KCCQ and PGA) will~     be assessed. For participants already taking ivabradine in either treatment group, the heart~     rate may again be used to adjust the dose of ivabradine. For participants not yet receiving~     ivabradine, it may be initiated at the provider's discretion. All participants will receive a~     90 (+/-7) day post-discharge phone call by site to assess for event status and tolerability~     of ivabradine. All participants will have a final study visit at 180 (+/-14) days~     post-discharge. Heart rate, systolic blood pressure and quality of life (Kansas City~     Cardiomyopathy Questionnaire and Patient Global Assessment) will be assessed. The attending~     physician may initiate ivabradine per usual care clinical practice.~      The primary hypothesis of the PRIME-HF study is that, compared with usual care, a treatment~     strategy of initiation of ivabradine prior to discharge for a hospitalization with acute HF~     will be associated with a greater proportion of participants using ivabradine at 180 days.~     Secondary objectives are to assess the impact of predischarge initiation of ivabradine~     on:Heart Rate (Change in heart rate from baseline to 180 days and Median heart rate at 180~     days) and Patient-Centered Outcomes (Kansas City Cardiomyopathy Questionnaire (KCCQ) and~     Patient Global Assessment (PGA)). Tertiary objectives will be to explore the impact of~     predischarge initiation of ivabradine on other assessments of evidence-based implementation~     of ivabradine and beta-blockers at 180 days. Evaluations will incorporate data based on~     whether or not indication status was retained and whether or not an ivabradine prescription~     was provided. Tolerability of ivabradine and adverse events during study follow-up.~   "
56496|NCT02827487|"~     Two hundred and ten women requesting IUD insertion will be randomly divided into three equal~     groups. To ensure blinding the double dummy technique will be used in which group 1 will~     receive Tramadol 100mg (Trama®, Global Napi, Giza, Egypt) orally in addition to a placebo~     similar to Celecoxib, group 2 will receive Celecoxib 200mg (Celebrex® 200, Pfizer, USA) in~     addition to a placebo similar to Tramadol, and group 3 will received a placebo similar to~     Tramadol in addition to a placebo similar to Celecoxib. All the drugs will be given 2 hour~     before the procedure.~      After insertion of the IUD the women's pain perception will be assessed using a visual~     analogue scale (VAS) graduated from zero to 10 with zero corresponding to no pain and 10~     corresponding to the worst possible pain.~   "
56497|NCT02827474|"~     The purpose of this study is to determine aspects of abortion care most important to the~     patient in creating a high quality abortion experience, to investigate patients'~     expectations of abortion care, and to explore provider perceptions of patients' abortion~     experiences and assess concordance with patients' perspectives.~   "
56498|NCT02827461|"~     The purpose of this study is to understand the hereditability of sleep homeostasis, i.e.,~     drive for sleep by looking at monozygotic and dizygotic twins.~   "
56499|NCT02827448|"~     The purpose of this study is to test how well the NephroCheckTM Test, a noninvasive~     laboratory test performed on urine, predicts loss of kidney function in patients that have~     had a heart transplant or a Left Ventricular Assist Device (LVAD) or Total Artificial Heart~     (TAH) implanted.~   "
56500|NCT02827435|"~     Reperfusion of renal graft in kidney transplantation can change the~     pharmacokinetic-pharmacodynamic (PKPD) parameters of rocuronium. The immediate increase of~     urine output during surgery may change the PKPD parameters of the drugs, including~     elimination rate. The goal of this study is to characterize the PKPD model of rocuronium~     during kidney transplantation and establish a basis for adequate dosage of rocuronium in~     kidney transplantation.~      Through PKPD modeling, the changes during reperfusion of the renal graft will be evaluated.~     Furthermore, the factors related to the changes will be assessed. Adjusting the infusion rate~     according to the step of kidney transplantation will lead to stable muscle relaxation and~     fast recovery.~   "
56501|NCT02827422|"~     Therapeutic hypothermia after out-of-hospital cardiac arrest is considered as a standard~     care. However, optimal candidates, optimal dose, duration, timing of initiation and rate of~     rewarming is still unknown. The objective of this project is to improve the outcomes for~     patients after resuscitation from out-of-hospital cardiac arrest treated with therapeutic~     hypothermia established from the analysis of multicenter registry data.~   "
56502|NCT02827409|"~     To determine whether performing extended delayed cord clamping in term neonates that require~     resuscitation improves early transition as compared to short-delayed cord clamping.~   "
56567|NCT02826564|"~     The goal of the proposed research project is to assess the safety (dose limiting toxicity,~     DLT) of the combination of pembrolizumab and high-dose stereotactic body radiotherapy (SBRT)~     in patients with metastatic urothelial cancer. Both the SBRT dose and pembrolizumab dose will~     be fixed, but the timing of the combination will be varied. Secondary objectives include~     response rates, local control, progression-free survival (PFS) and overall survival (OS).~     Exploratory endpoints include immunologic responses and response rates in PD-L1- TIL- tumors.~     The combination sequence with the most promising response rates and the best safety profile~     will be selected to continue in a Phase II trial.~   "
56503|NCT02827396|"~     Background: It is asserted that 85% of disabled children live in resource poor countries with~     few available disability services. Measurements have shown an increase in disability~     prevalence from 2% to 4% over the past three decades in Malawi. A recent prevalence study in~     Mzuzu city, found 19.7% disability prevalence with associated social and psychological burden~     of care; marriage disruptions and divorces among parents of disabled children due to stigma~     and cultural misconceptions about disability.~      Studies have shown a link between parenting children with intellectual disabilities and~     parental psychological health problems and overall Quality of life. However, with~     interventions, these negative impacts are not as severe as once thought.~      Research Objectives: This study aims to design a Malawi specific Psychosocial Training~     Intervention for parents with intellectually disabled children and assess the impact of the~     Intervention in reducing psychological distress among these parents in Malawi.~      Methodology: This study will use mixed methods design. It will employ an explanatory~     sequential design, where by qualitative data collection and analysis builds to quantitative~     data collection and analysis; and final interpretation.~      The study will be conducted within catchment areas of two disability organisations that are~     operating in Mzuzu and Lilongwe.~      On sample size for the quantitative part, calculation using 5% level of statistical~     significance, power of 90% and effect size of 0.4 [effect size found in recent meta-analysis~     for similar intervention, gives 81 participants in each arm of the intervention.~     Questionnaire with social-demographic data in section one; and Self-Reported Questionnaire~     will be administered at baseline, 6 & 12 months follow-up. Quantitative data will be coded on~     a computer, cleaned and analyzed using STATA. Mann-Whitney test will be used to measure the~     impact of the intervention. Qualitative data will be analysed using content analysis with the~     help of Nvivo.~      All ethical consideration will be followed to ensure that subjects are treated with respect;~     allow for their right to refuse participation in the study; and conducting interviews in~     privacy.~      Dissemination: Findings will be disseminated through Continous profesional development (CPD)~     sessions at the two clinic sites; Research Dissemination Conferences in Malawi and~     Sub-region; and three manuscripts submission for publication in peer reviewed journals.~   "
56504|NCT02827383|"~     This pilot study seeks to demonstrate feasibility to conduct data collection and illustrate~     potential for effect of fractionalized bouts of stair climbing on glucose control in adults~     at risk for type 2 diabetes.~   "
56505|NCT02827370|"~     The purpose of the study is to determine if a targeted dietary change can enhance the effect~     of neo-adjuvant chemotherapy~   "
56506|NCT02827357|"~     This chart review describe the response to systemic chemotherapy of patients with non-small~     cell lung cancer (NSCLC) harbouring a known somatic activating human epidermal growth factor~     receptor 2 (HER2) mutation. The analysis of this data will provide an initial description of~     the response to systemic chemotherapy in patients with NSCLC harboring an activating HER2~     mutation in order to inform the design and powering of future randomized controlled clinical~     trials of HER2-directed therapy.~   "
56507|NCT02827344|"~     Immunotherapy is probably, since the development of therapies targeting EGFR mutations or ALK~     rearrangement, the most attractive therapeutic perspective in the management of metastatic~     lung cancer. Among the compounds tested, the inhibitors of the immune checkpoint PROGRAMME~     DEATH 1 / PROGRAMME DEATH LIGAND 1 (PD-1/PD-L1) have been tested in numerous clinical trials~     with recently published positive results leading to the approval of one drug in the USA and~     an expanded access program for two drugs in France. PROGRAMME DEATH LIGAND 1 (PD-L1)~     expression by tumor cells is strongly associated with the response to such molecules so that~     the participation in various clinical trials is currently reserved for patients expressing~     this biomarker and therefore justifies a new invasive biopsy (bronchoscopic or CT-guided)~     representing a considerable drag on the access to these treatments. Circulating tumor cells~     (CTCs) isolated by Isolation by Size of Tumor Cells (ISET) offer a direct and non-invasive~     access to the tumor. It has already been demonstrated that molecular characterization (EGFR,~     ALK) on these blood samples is possible. We propose to demonstrate the feasibility of the~     analysis PDL-1 expression in these cells by immunocytochemistry.~      Myeloid-Derived Suppressor Cells (MDSCs) are immature myeloid cells that inhibit T cell~     functions and thus promote tumor growth. These cells frequently express PD-L1. We propose to~     test whether MDSCs level and its evolution during treatment with PD1 inhibitor is correlated~     to the response to these drugs.~      The main objective of this study is to demonstrate the feasibility of the analysis of PD-L1~     expression on CTC~   "
56508|NCT02827331|"~     The question of the inclusion of periods of interruptions and periods unobservable has been~     studied as part of medico-administrative databases. However, the specificity of the health~     insurance databases justify the realization of dedicated methodological research. A thorough~     knowledge of the purpose of these data, how they collect and restitution is an essential~     prerequisite to carry out this work.~      One type of scheme cohort exposed/unexposed led to the formulation of a finding on the basis~     of the comparison between the exposure groups. However, this traditional approach has the~     major drawback of neglecting the changing nature of drug exposure, and therefore fails to~     take into account any changes or interruptions doses. Approaches to take into account the~     time dependent variables were developed. These allow to take into account any interruptions.~     However, as part of study on health databases, sometimes we do not have the status in~     relation to the exhibition on the entire monitoring period. This is for example the case~     during hospitalization. The bias generated by the failure to take account of these periods~     (non measurable time bias) can be problematic when a long exposure and chronic disorders~     require hospitalization.~   "
56509|NCT02827318|"~     Reducing the glycaemic load (GL) of the diet may benefit appetite control but its utility is~     complicated by psychological influences on eating. Disinhibited behaviour, a risk factor for~     overconsumption, is characterized by reduced prefrontal cortex activity, which in turn~     directly modulates vagal tone; a phenomenon inversely associated with blood glucose (BG) and~     insulin levels. This double blind randomised controlled trial explores the influence of~     disinhibited eating and vagal tone (heart rate variability) on the postprandial response to~     GL and hunger.~   "
56510|NCT02827305|"~     This study evaluates the adjunctive use of Centella Asiatica (gotukola) to scaling in the~     reduction of plaque and gingival inflammation. Patients were divided into three groups of~     which group 1 received scaling and gotukola mouthwash, group 2 received scaling only and~     group 3 received gotukola mouthwash only.~   "
56511|NCT02827292|"~     This study evaluates the effect of per-operative music on the bio-molecular inflammatory~     response in laparoscopic surgery. Per-operative music intervention will be given to the test~     group via headphones while the control group will be applied headphones without any music~     (Silent). The inflammatory stress response will be measured postoperatively at 6 hours and 24~     hours postoperatively along with the baseline levels measured preoperatively. The values will~     be compared between the test and control groups.~   "
56590|NCT02826265|"~     Current diagnostic tools used in pulmonary disease often do not meet the challenges set by~     the respective pathophysiology. The investigators therefore aimed to evaluate novel or not~     widely used diagnostic approaches for the detection and therapeutic monitoring of patients~     with various pulmonary diseases.~   "
56512|NCT02827279|"~     The Pervasive Developmental Disorders (PDD) are severe neurodevelopmental disorders,~     affecting nearly 1% of the general population. The disorder of social interaction has often~     been described as resulting from poor emotion recognition, or a bad perception of biological~     motion. However, the results of studies on these issues are very divergent. The PDD also been~     described as a disorder of emotion regulation, but few studies address the emotional feelings~     of individuals with ASD and their neuropsychological implications.~      The main objective is to study the effect of induced emotion in the children with ASD on his~     visual exploration strategies.~      This is a comparative exploratory pilot study. We'll look at using the eye-tracking, policy~     terms of the look in a group of children with ASD, in a context of emotional induction (joy,~     fear, sadness or anger) using of sound stimuli.~   "
56513|NCT02827266|"~     This study will evaluate the effect of epoetin beta (NeoRecormon) on correction of anemia and~     quality of life in participants with diabetes and chronic renal failure and who are not~     receiving dialysis.~   "
56514|NCT02827253|"~     The purpose of this study is to describe brain´s morphological changes induced by chronic~     kidney disease (CKD) in advanced stages (stages 4 and 5 defined by KDOQI guidelines) and also~     by haemodialysis using MRI.~      Based on the hypothesis that hypotension may cause damage in some organs including brain the~     investigators study if intradialytic hypotension (IDH) causes any type of changes in gray and~     white matter of the brain.~   "
56515|NCT02827240|"~     ZEST is a cluster-randomized trial designed to determine whether HIV self-tests are~     acceptable and improve HIV testing rates and HIV status knowledge among female sex workers in~     Zambian transit towns. This study will determine whether directly giving participants an HIV~     self-test or giving them a coupon to collect a test at a drug store or clinic improves~     outcomes compared to standard of care.~   "
56516|NCT02827227|"~     The objective was to identify factors associated with the normalization of the CD4/CD8 ratio~     (>=1) in patients with a history of primary HIV infection (PHI) and long-term combined~     antiretroviral therapy (cART).~   "
56517|NCT02827214|"~     Thoracolumbar (TL) burst fractures in neurologically intact patients account for~     approximately 45% of all TL spine injuries. Despite being common fractures, there is~     significant variability in treatment recommendations encompassing surgery and non-surgical~     treatment options. The controversy regarding optimal treatment for these injuries is fueled~     by several studies which suggest a potential benefit to surgical treatment in the realm of~     patient satisfaction, and the overall socio-economic burden of treatment while other studies~     demonstrate improved outcomes and lower morbidity with non-surgical treatment. This study~     aims to perform a prospective cohort analysis investigating the clinical outcome of various~     treatment alternatives for patients with A3/A4 fractures in the thoracolumbar region. A~     cost-effectiveness analysis will also be performed to identify costs and benefits of each~     treatment option. More specifically a sub-group analysis will be performed for this group of~     patients, which have equipoise in regards to patients treatment, as decided by a blinded~     review panel.~   "
56518|NCT02827201|"~     The main objective of this trial is to evaluate every 2 months alternating~     nab-paclitaxel/gemcitabine and FOLFIRI.3 versus nab-paclitaxel + gemcitabine, regarding the~     progression of disease at 6 months.~   "
56519|NCT02827188|"~     The objective of the Cognitive Restructuring in ADHD: Functional Training (CRAFT) study is to~     develop a non-pharmacological intervention program for children with Attention Deficit~     Hyperactivity Disorder (ADHD). ADHD is a childhood onset clinical disorder of inattention,~     hyperactivity, and impulsivity. The present study will investigate the validity, feasibility~     and efficacy of this novel intervention.~   "
56520|NCT02827175|"~     Annually about 10 to 15 million international travelers from Europe visit tropical countries.~     Returning from a journey, fever is the cardinal symptom of many infections. This is the~     second reason for consultation (23%) for return from a trip, after digestive disorders (42%).~     Urgent evaluation must always be proposed. Although that may be the manifestation of a benign~     disease, fever of return can also presage a rapidly progressive and lethal disease. In 50% of~     cases, patients return home, after treatment and disappearance of symptoms, though the~     microorganism responsible for the pathology is not able to be identified. The prescription of~     a series of systematic biological examinations in the form of a diagnostic kit has shown its~     relevance and its effectiveness in improving the etiological diagnosis of endocarditis and~     pericardites for optimal support. In this study we propose to assess the effectiveness of the~     systematic prescription of a diagnostic kit 'fever of the traveler' to all patients~     hospitalized with a fever after returning from a trip. Ready to use kit brings together in~     a single bag (i) instructions for use, (ii) the tubes, bottles and jars for the etiological~     diagnosis of fever of the traveler in the usual support (iii) an additional blood tube for~     research of pathogens emerging.~      Primary:~      To assess the effectiveness of a diagnostic kit for the etiological diagnosis of fevers of~     travelers on the return.~      Hypothesis:~      Improvement of at least 15% of the etiological diagnosis of fevers of travelers on the return~     through the development of a diagnostic kit.~   "
56521|NCT02827162|"~     Primary objectives:~        -  To assess how dengue vaccine efficacy varies across participant subgroups regarding~          polymorphism in human leukocyte antigen (HLA) alleles of interest.~        -  To assess the association between HLA alleles and, serotype-specific neutralization~          antibody titers and summary neutralization measure in the vaccine and placebo groups.~        -  To assess the association between the polymorphism in HLA alleles of interest and~          susceptibility to Dengue fever and Dengue Haemorrhagic fever.~      Secondary objectives:~        -  To assess whether dengue serotype-specific neutralizing antibody titers and associated~          summary neutralization measure at 28 days post-dose 3 are related to the rate of~          occurrence of symptomatic Virologically-confirmed dengue infection after post-dose 3~        -  To evaluate whether the dengue serotype-specific neutralizing antibody and associated~          summary neutralization measure at 28 days post-dose 3 are related to the level of~          vaccine efficacy against dengue viruses after post-dose 3.~   "
56576|NCT02826447|"~     This project is a prospective observational cohort study to quantify the risk of acquiring~     Hepatitis C virus (HCV) infection for patients and healthcare workers in Ain Shams University~     Teaching Hospital, Cairo, Egypt through: 1) identifying typical patient trajectories within~     the hospital; and 2) assessing the ward-specific risk based on the type and number of~     procedures performed and the prevalence of HCV viremia in patients within each ward.~   "
56522|NCT02827149|"~     Italian, retrospective, prospective, observational, multicentre, spontaneous,~     non-interventional, non-pharmacological The study aims to analyze in the national Italian~     experience~        1. The compatibility level selected by the Italian Transplant Centres using an high~          resolution HLA typing at the start of search process for hematopoietic stem cell~          transplantation from volunteer unrelated donor~        2. The transplant outcomes in terms of Overall Survival, Disease Free Survival, Relapse~          Rate and Transplant Related Mortality and the correlation with the level of HLA matching~          pairs of donor/recipient included in the Italian Bone Marrow Donor Registry and Promise~          registry.~        3. The possible identification of allelic mismatching combinations characterized by~          increased cross-reactivity associated with higher incidence of acute or chronic~          graft-versus-host disease .~        4. The possible identification of combinations of allelic mismatching characterized by~          higher permissiveness.~   "
56523|NCT02827136|"~     The primary purpose of this study is to investigate the effect of lidocaine patch on the~     shoulder pain score after end of surgery.~      The secondary purpose of this study is to investigate the effect of lidocaine patch on the~     total number of analgesic request on ward.~   "
56524|NCT02827123|"~     The primary purpose of this study is to investigate the effects of McGrath MAC~     videolaryngoscopy on the intubation time for orotracheal intubation in children.~      The secondary purpose of this study is to investigate the effects of McGrath MAC~     videolaryngoscopy on Cormack and Lehane Grade for orotracheal intubation in children.~   "
56525|NCT02827110|"~     A semi-rigid cervical collar is recommended for immobilization of the cervical spine in~     patients with cervical spine injury. It has been suggested that a reduction in mouth opening~     is the major contributing factor to the deterioration in the glottic view obtained.~     Fiberoptic intubation is among the most versatile techniques for managing both the~     anticipated and the unanticipated difficult airway. Recently, combination of fiberoptic~     bronchoscope with videolaryngoscope has been suggested to permit visual control of the~     passage of the tube over the fibrescope into the laryngeal inlet. The aim of this study is to~     compare the intubation time and ease of intubation between fiberoptic bronchoscope alone and~     bronchoscope with pentax airwayscope.~   "
56526|NCT02827097|"~     The primary purpose of this study is to investigate the effect of rectus sheath block on~     abdominal pain score after robotic single port cholecystectomy.~      The secondary purpose of this study is to investigate the effect of rectus sheath block on~     fentanyl consumption during stay of recovery room after surgery.~   "
56527|NCT02827084|"~     The study aims to analyze the immediate effects and 72 hours after application of the Kinesio~     Taping (KT) in the electromyographic activity of the vastus medialis oblique (VMO) and vastus~     lateralis (VL), the isokinetic performance of the quadriceps and referred pain of subjects~     with PFPS. The volunteers will be randomly assigned to one of the three groups and perform~     one of the protocols: control - remain at rest; KT - application of Kinesio Taping with~     tension in the VMO region; placebo - application of Kinesio Taping without tension, in the~     same region. All volunteers will be submitted to the evaluation of pain intensity, the~     electromyographic activity of the VMO and VL and dynamometric parameters in 3 times: before~     the application of KT, immediately after the application of KT and after 72h of application.~     Average effect estimates (differences between groups) for all variables will be calculated~     using the mixed model ANOVA with a significance level of 5% (p ≤ 0.05).~   "
56528|NCT02827071|"~     The purpose of this study is to evaluate this AngioScan angiography software on patients with~     various retinal vascular disorders. The advanced OCT instrument is an FDA approved clinically~     used camera, but the AngioScan angiography software is not FDA approved. Investigators would~     like to know if this imaging device and software can improve the quality of images and~     visualization of imaged tissues and whether they are useful in the diagnosis and treatment of~     eye diseases. Images collected in this study may be compared to other images collected as~     part of standard of care on the same patient (OCT, FA, AF, Fundus).~   "
56529|NCT02827058|"~     The purpose of this study is to determine whether injection needle pen point type 'PP Gauge~     25' should be recommended as a primary choice of needle (in stead of 'PP Gauge 27') for~     healthy pregnant women who at delivery (vaginal or cesarean section) get spinal anesthesia.~   "
56530|NCT02827045|"~     Bipolar Disorder show cyclic changes of mood between depression (depressive phase) and mania~     (maniac phase). Vestibular tests have been shown high sensibility and specificity as a~     biological marker for major depression. This exploratory investigation will measure and~     compare the vestibular activity of bipolar disorder patients during different phases ( 6~     depressed phase, 6 maniac phase, 6 euthimic and 6 control healthy subjects).~   "
56531|NCT02827032|"~     To perform post-market surveillance and evaluate the performance of the MobiusHD System in~     subjects with primary resistant hypertension.~   "
56532|NCT02827019|"~     Motherhood Our Lady of Good Help is from the 2006 merger of three hospitals, St. Joseph, Our~     Lady of Good Help and Saint-Michel. She was transferred to a new building in the heart of~     Paris Saint-Joseph Hospital Group website in March 2011. The premises of the birth room are~     spacious and nice. All delivery rooms are supposed to welcome the mother and child when the~     birth goes smoothly. There is a resuscitation room (called Nursery) for newborns requiring~     medical care. But since the installation in the new building, we had the impression that a~     number of children born without pathology futures and with good adaptation at birth passed~     through this room for no apparent medical reason.~      We wanted to make an inventory of home practice healthy newborns in our maternity, evaluate~     the reasons for a possible separation and appreciate the feelings of mothers cope with this~     separation.~   "
56533|NCT02827006|"~     CaP Cement is Equivalent to Iliac Bone Graft in Filling of Large Metaphyseal Defects~   "
56534|NCT02826993|"~     A total of 8000 colonoscopies are performed on a yearly basis on the Funen Island. Between 5%~     and 10% of those are incomplete due to excessive pain, fixed colon loops, and other reasons.~     The current standard procedure is to refer the patient to the department of radiology for a~     CT-colonography. In some instances the radiology department can offer the investigation the~     next day, and thus in the same colon preparation. At other times they cannot, and the patient~     has to go through an second colon preparation for the colonography.~      A CCE procedure could be provided to the participants immediately after the failed~     colonoscopy and the investigation can be completed the next morning in the same bowel~     preparation without a visit to the radiology department.~   "
56535|NCT02826980|"~     Endometriosis is defined as the presence of endometriotic tissue outside the uterus. Its~     pathophysiology is still misunderstood today, but more and more work on this pathology are~     published. The clinical presentation is generally characterized by the existence of cyclical~     pelvic pain, with dysmenorrhea, dyspareunia, dysuria, dyschezia.~      But, there are a wide variety of symptoms, with different painful sites and different types~     of pain.~      The estimated prevalence of endometriosis is about 10% in women. But the impact of this~     disease on quality of life and its economic impact is estimated considerable. In a US study,~     the direct costs associated with endometriosis were estimated at US $ 2.801 per woman. Some~     studies have focused also to quantify work absenteeism associated with endometriosis.~      The etiology of endometriosis is based on the migration of endometrial fragments reaching the~     pelvis via the tubes and establishing themselves on other sites, thus creating non cyclical~     uterine pain. Catamenial pace of pain is suggestive of the diagnosis, but with time, the pain~     tends to be chronic rather than cyclical. The standard diagnosis is based on visualization~     and histological examination of the lesions.~      The wide variety of symptoms of endometriosis often leads to wandering and medical diagnostic~     delay. A better understanding of this disease by the medical community would allow better~     management of these patients. Currently, endometriosis remains a misunderstood disease by~     rheumatologists. However, the initial presentation may mimic rheumatologic symptoms; thus,~     rheumatologists may face this disease.~      The purpose of this study was to determine the prevalence and characteristics of~     manifestations of endometriosis in a cohort of patients with a recent diagnosis of~     endometriosis established. Secondly, it may well be possible to establish a list of symptoms~     and signs suggestive of endometriosis for the rheumatologist, allowing to contact a~     specialized consultant gynecologist some patients by mistake in rheumatology.~   "
56536|NCT02826967|"~     This study will allow investigators to determine whether colonic irrigation may allow for a~     non-oral, same-day alternative to traditional oral bowel prep regimens. This in turn could~     lead to more persons able to undergo screening colonoscopy for colorectal cancer and thus~     increased cancer prevention and early detection.~   "
56537|NCT02826954|"~     The study is based on the theory of a unified airway that considers the nose and paranasal~     sinuses together with lower airways as one integrated unit. The upper and lower respiratory~     tracts function as an interdependent physiologic mechanism, and stimuli that trigger changes~     in one portion of the airway, can provoke similar changes throughout the airway. This is well~     documented in asthmatic patients but documented poorly in patients suffering from chronic~     obstructive lung disease (COPD).~      COPD is associated with sinonasal symptoms and decreased quality of life. Although nasal~     involvement has been found to directly affect the lower airway, sinonasal disease is~     under-diagnosed and under-treated in patients with COPD. This study is embedded in a larger~     project where the goal is to gain knowledge supporting the theory of a unified airway in~     patients with COPD.~      Here sinonasal, pulmonary and generic health related quality of life will be studied in a~     group of patients with COPD versus a control group. The severity of nasal airway obstruction~     will be linked to the the severity of pulmonary airway obstruction. Assessment of~     pathological changes in the nose with nasal endoscopy, as well as performing a nasal~     cytological brushing for the identification of nasal inflammatory responses in the nose, will~     be conducted in both the control and study group.~   "
56538|NCT02826941|"~     This study was a multicenter, randomized, controlled pilot trial of moderate systemic~     hypothermia (33°C) vs normothermia (37°C) for 48 hours in infants with neonatal~     encephalopathy instituted within 6 hours of birth or hypoxic-ischemic event.~   "
56539|NCT02826928|"~     Urinary measure of 5-hydroxyindolacetic acid (5HIAA) is an important marker for the diagnosis~     and follow-up of patients with small-intestine neuroendocrine tumors. Although this marker~     has good specificity, its sensitivity is moderate and its dosage is constraining, since it~     requires urine collection over 2-3 days and specific diet. Preliminary data suggested that~     overnight 5HIAA value may be representative of 24-hour 5HIAA value, and that plasma 5HIAA~     dosage could be a valuable alternative to urine 5HIAA dosage. The main objective of this~     study is to compare sensitivity and specificity of overnight 5HIAA value, 24-hour 5HIAA value~     and plasma 5HIAA value, in patients with small-intestine neuroendocrine tumors.~   "
56540|NCT02826915|"~     Epilepsy in children is a major public health issue. It is the first neurological disease of~     the child. The specific incidence of epilepsy rates were highest during the first year of~     life, between 75,105 and 250,105 hab.an hab. year and remain high in the age group between 0~     and 10 years. Epilepsies predictions are varied. They can be spontaneously benign, drug-,~     chemically dependent or drug-resistant. These, refractory epilepsies, represent 20% of~     epilepsy as a child and adolescent than adult is about 1200 children and 1200 adults Picardy.~     The validation of non-invasive investigative tools is becoming a necessity in the management~     of drug-resistant epilepsies especially when a surgical decision is envisaged. The aftermath~     (motor, cognitive, sensory) appear to rule early; but they are sometimes limited to learning~     deficits detected later in the school curriculum. The investigators know that defects in~     neuronal electrical activity (eg critical discharges) induce a metabolic response and~     conversely metabolic disturbances can cause abnormal electrical activity. It is therefore~     important to have tools to better characterize the interactions between these two mechanisms~     to better understand brain function in the brain during development and during pathological~     situations. The investigators lack quantitative criteria regarding the impact of crises on~     the metabolic activity and thus predictive criteria consequences of crises on brain function.~     The deleterious hazard must be considered at all ages in both structures to causing seizures~     than in those where the crisis spread. The functional characterization, electrical, metabolic~     and anatomic pathology of these networks is necessary and contributes to a better~     understanding of physiological and pathological brain function, and helps to define the most~     appropriate treatment strategy.~      About childhood epilepsy, analysis of the EEG allows in 75% of cases to find predictive~     patterns characteristic of becoming. However in 25% of cases, we lack predictive objective~     criteria. This highlights the importance of developing analysis tools for more accurate and~     efficient brain function and to improve the management and evaluation of the prognosis of~     these children.~   "
56541|NCT02826902|"~     The effect of total intravenous anesthesia (TIVA) versus inhalational anesthesia on the~     quality of recovery from surgery has been reported in several different types of operations.~     The Quality of Recovery 40 (QoR-40) questionnaire is designed multi-dimensionally to assess~     the degree of recovery after anesthesia and surgery, and has been validated in previous~     studies. Limb lengthening surgery is unique in that it is usually purely cosmetic, and the~     patients are mostly young and healthy patients. The present study aims to compare the quality~     of recovery with the QoR-40 questionnaire, in patients undergoing bilateral limb lengthening~     surgery under general anesthesia with either TIVA with propofol or inhalational anesthesia~     with desflurane.~   "
56554|NCT02826733|"~     Many cognitive functions in human are based on asymmetric brain networks. For most adults,~     language is processed largely by the left hemisphere while other auditory treatments, such as~     voice recognition are rather based on the right hemisphere. Many studies helped to highlight~     the presence of anatomical and functional asymmetries both in the first months of life. What~     are the causes of these imbalances? How do they develop? Are they necessary for operation or~     for effective learning?~      The investigators would like in this work, in collaboration with applied mathematics team of~     Compiègne and INSERM team, to determine from which period the development of hemispheric~     dominance is set up for recognition of language and in which brain structure it occurs in~     preterm infants whose sound environment is usually very different from that of the fetus. The~     impact of this environment on brain development of infants and their early learning will be~     assessed.~   "
56542|NCT02826889|"~     Appropriate fluid management is an important part of anesthesia in patients undergoing~     surgery, and several dynamic indices have been suggested to have high predictability for~     fluid responsiveness in patients receiving mechanical ventilation. Among various surgical~     positions, the prone position is known to cause unique physiologic and hemodynamic changes~     and affect the predictability and cut-off values of dynamic indices for fluid responsiveness.~     A previous study reported that pulse pressure variation (PPV) and corrected flow time were~     able to predict fluid responsiveness with relatively high accuracy in patients undergoing~     spine surgery in the prone position using a Wilson frame. However, the Jackson frame is known~     to have less effects on the cardiovascular system compared to the Wilson frame, and therefore~     may be physiologically more appropriate in patients undergoing surgery in the prone position.~     The pleth variability index (PVI) is a dynamic index that can be monitored non-invasively in~     patients under mechanical ventilation. The present study aims evaluate the validity of PPV~     and pleth variability index (PVI) as predictors of fluid responsiveness in the supine and~     prone positions in patients undergoing posterior lumbar spinal fusion using the Jackson~     table.~   "
56543|NCT02826876|"~     Using local analgesia in laparoscopic surgery in order to reduce pain and to reduce the use~     of narcotic drugs.~   "
56544|NCT02826863|"~     This is a multicenter, double-blind, parallel-group, placebo-controlled, study to assess the~     efficacy, safety, and pharmacokinetics of ZX008 when used as adjunctive therapy in pediatric~     and young adult subjects with Dravet syndrome. Subjects who qualify for the study will be~     randomized (1:1:1) in a double-blind manner to receive 1 of 2 doses of ZX008 or placebo. All~     subjects will be titrated to their randomized dose over a 14-day Titration Period. Following~     titration, subjects will continue treatment at their randomly assigned dose over a 12-week~     Maintenance Period. Total treatment time from the beginning of the Titration Period through~     the end of the Maintenance Period is 14 weeks.~   "
56545|NCT02826850|"~     This project is one of four components of a thematic project that aims to evaluate the use of~     ultrasound in regional and infiltration blocks, called Use of ultrasound in regional blocks~     and infiltration for the treatment of acute and chronic pain.~      It aims to evaluate quantitatively and qualitatively the knee pain control in patients with~     osteoarthritis after neurotomy by saphenous nerve radiofrequency guided by ultrasound ,~     compared to neurotomy by radiofrequency of genicular nerves guided by fluoroscopy .~      Differences between total consumption of analgesics, side effects of medications , impact on~     quality of life and functional capacity in patients undergoing saphenous nerve neurotomy by~     radiofrequency guided by ultrasound compared to neurotomy by radiofrequency of genicular~     nerves guided by fluoroscopy, will also be evaluated.~   "
56546|NCT02826837|"~     A Phase I/IIa Dose-Escalation Study Evaluating the Safety, Tolerability and Efficacy of~     LEAC-102 in Combination with FOLFOX + Bevacizumab/Cetuximab in Subjects with Advanced~     Colorectal Cancer~   "
56547|NCT02826824|"~     The corpus callosum agenesis is an interesting malformation between 0.05% and 1.5% of the~     general population. This malformation is mostly diagnosed prenatally by ultrasound, usually~     at 22 weeks of gestation, and the use of prenatal advice is routinely offered to the couple.~      Several studies in recent years have helped to define the determinants of prognosis for the~     unborn child suffers from agenesis of the corpus callosum, whether total or partial. These,~     mainly retrospective, demonstrated that the isolated nature of the deformity (defined as no~     other brain malformations and brain extra, absence of abnormal karyotype, maternal poisoning~     or viral seroconversion when pregnancy) is associated with favorable developments in terms of~     psychomotor development in 80% of cases Similar results were also found in prospective~     studies, while the associated nature of the defect seems most heavily encumber the prognosis~     as other malformation or syndrome associated with agenesis of the corpus callosum Although~     these recent data have already significantly influence prenatal counseling and outcome of~     pregnancy, questions about the future of the child carrying a prenatal diagnosis of agenesis~     of the corpus callosum are still valid.~   "
56548|NCT02826811|"~     BKV nephropathy (BKV) is one of the most frequent complications of kidney transplantation.~      In the absence of specific anti-BKV treatment, pre-emptive reduction of immunosuppression is~     the main strategy that has proven effective in reducing the risk of BKVN. However, it exposes~     a transplant rejection risk estimated between 4 and 14% according to studies.~      Despite the pre-emptive reduction of immunosuppression, a significant number of patients~     continue to progress towards BKVN suggesting that pre-emptive strategy is late. It's~     therefore urgent to develop new prognostic markers to identify earlier and more effectively~     patients with a higher risk of developing BKVN.~   "
56549|NCT02826798|"~     The purpose of this study is to compare the safety and effectiveness of four different doses~     of cytomegalovirus vaccines in healthy adults.~   "
56550|NCT02826785|"~     This study investigates the feasibility of a cognitive strategy training intervention for~     people with Parkinson disease (PD). We plan to recruit 8 non-demented PD participants to~     complete 6 weekly treatment sessions and Pre- and Post-testing (8 sessions total, entire~     study duration per participant = 8 weeks). We will measure participant responsiveness and the~     overall efficiency of the intervention process.~   "
56551|NCT02826772|"~     This study is an open-label, non-randomized, dose escalation study in subjects with~     metastatic castrate resistant prostate cancer (mCRPC) who progressed after both hormonal~     therapy (abiraterone or enzalutamide) and chemotherapy (docetaxel), or cannot tolerate either~     or both therapies.~      There will be two treatment phases:~      Phase 1 (dose escalation stage): Multiple dose escalations of GT0918 (proxalutamide) to~     establish safety and tolerability.~      Phase 2 (dose expansion stage): Identify two dose levels from Phase 1 to further evaluate the~     safety, tolerability and antitumor activity of GT0918 (proxalutamide); subjects will be~     randomized into the 2 treatment arms.~   "
56552|NCT02826759|"~     This study is designed to compare the serum sphingolipidomic analyses in healthy,~     pre-diabetic and diabetic subjects. age, sex and BMI are matched among these three groups. As~     ceramide, sphingosine, sphingosine-1-phosphate and sphinganine are involved in inflammation,~     immunity and cancer, investigators proposed a hypothesis that sphingosine-1-phosphate and~     other sphingolipids may be associated with the progress of type 2 diabetes. sphingolipids may~     be a biomarker for diabetes.~   "
64791|NCT02718885|"~     The overall objective of the study is to examine the changes within the gut microbiome after~     the supplementation of inulin and its effect on markers of mineral metabolism and bone~     turnover.~   "
56555|NCT02826720|"~     The aim of present study is to investigate any relationship between hyperlipidemia and~     periodontal disease regarding the periodontal parameters and plasma lipid parameters, along~     with age, gender, brushing habit, body mass index, dietary habit, physical activity, alcohol~     consumption.~      In this cross sectional study, a total of 160 individuals were divided into two groups based~     on their metabolic status: hyperlipidemic group (n=97) and normolipidemic group (n=63).~     Plaque index, gingival index, bleeding on probing (BOP), probing depth (PD), clinical~     attachment level (CAL) clinical parameters and community periodontal index of treatment needs~     (CPITN) scores were measured. Triglyceride (TG), total cholesterol (TC), low density~     lipoprotein-cholesterol (LDL-C) and high density lipoprotein-cholesterol (HDL-C) levels had~     been determined previously during individuals routine systemic examinations. Daily brushing~     habits and interdental cleaning together with dietary habits, alcohol consumption and~     physical activity levels were also recorded.~   "
56556|NCT02826707|"~     Despite physical activity (PA) being a valuable modality for promoting health, the evidence~     for effective PA intervention strategies for manual wheelchair (MWC) users is underdeveloped.~     Community-based programs and telephone-counselling interventions to increase PA among MWC~     users have had some success, but the uptake and adherence to these interventions remains low~     within this population. Community-based programs may not reach MWC users who live in rural~     areas and have issues with transportation, while health professionals may not optimally~     relate with MWC when providing telephone counselling. Although the PA needs of MWCs are not~     fully understood, there is reason to believe that including peers into intervention delivery~     may have benefits.~      A feasibility trial is critical and prudent prior to moving forwards with a large and~     expensive multi-site randomized controlled trial (RCT) to ensure that: the intervention meets~     the needs of the target population; the right outcomes are measured; and that the~     intervention is feasible to administer.~      The objective of this study is to evaluate the feasibility of a Smartphone-delivered Peer-led~     Physical Activity Counselling (SPPAC) program for MWC users.~   "
56557|NCT02826694|"~     The NC NEXUS research study is exploring the utility of next generation sequencing in newborn~     screening and parental decision making. The National Institutes of Health (NICHD and NHGRI)~     are co-funding this study under a single U-19.~   "
56558|NCT02826681|"~     Treatment Phase I and II Primary Objective: To evaluate the efficacy and safety of FCM (750~     mg dose x 2) for treatment of Restless Legs Syndrome (RLS) in patients with iron-deficiency~     anemia (IDA).~      Long-Term Extension Phase III Primary Objective: To evaluate the duration of effect of prior~     FCM treatment and to determine the effectiveness of further iron repletion with FCM when RLS~     symptoms worsen or reoccur.~   "
56559|NCT02826668|"~     The aim of this study is to evaluate the impact of lumbar spine ultrasound on the success~     rate and efficiency of labor epidural placement in the lateral position. The investigators~     hypothesize that ultrasound imaging of the lumbar spine of women in early labor will yield~     similar ultrasound results when done immediately prior to epidural placement. The~     investigators also hypothesize that the use of ultrasound with landmarks marked and depth to~     the epidural space estimated will facilitate epidural placement in terms of both efficiency~     (time required for placement) and efficacy of pain relief.~   "
56560|NCT02826655|"~     This is a feasibility study to assess the use of wide field adaptive optics optical coherence~     tomography (WF-AO-OCT) to determine whether there are structural differences in the~     peripheral retina in participants diagnosed with diabetic retinopathy compared to a healthy~     control group. This study being conducted under an abbreviated IDE. The investigators will~     analyze data using descriptive statistics. Risks related to light exposure will be managed by~     ensuring that the exposure to the WF-AO-OCT light source is well below maximum permissible~     limits for safe exposure.~   "
56561|NCT02826642|"~     The purpose of this study is to evaluate the safety, tolerability and potential efficacy of~     IDH305 with standard treatments for newly diagnosed IDH1R132 mutant acute myeloid leukemia~     (AML).~   "
56562|NCT02826629|"~     The investigators recently showed that visuomotor integration was significantly altered in~     schizophrenic patients during: (i) a grip force task (Teremetz et al., 2014), and (ii) a~     saccadic paradigm (oculomotor task)(Amado et al., 2008). Given this findings, the~     investigators propose a combined study of oculomotor and grip force control to better~     characterize the sensorimotor integration deficit. This approach may allow for identification~     of behavioural biomarkers of vulnerability to develop schizophrenia.~   "
56563|NCT02826616|"~     Giving preoperative loading dose of 60mg of trimetazidine can safely and effectively reduce~     the PCI-related myocardial damage for the patients undergoing selective PCI. but the effect~     of Trimetazidine during the primary PCI on cardiac function in patients with ST-elevation~     myocardial infarction is not sure. this study aim to study the effect of Trimetazidine during~     the primary PCI on cardiac function in patients with ST-elevation myocardial infarction.~   "
56564|NCT02826603|"~     Demonstrate superiority of secukinumab over ustekinumab in treatment of moderate to severe~     plaque psoriasis.~   "
56565|NCT02826590|"~     This study investigates the effects of spinal mobilizations on symptoms, 3D movement of the~     neck, neck muscle electromyography and sympathetic nervous system activity in people with~     neck pain.~   "
56566|NCT02826577|"~     No studies to date have examined the effects of pregnenolone on hypervigilance for social~     threat in individuals with perceived social isolation (PSI). We therefore are conducting a~     double-blind randomized research study combining three validated behavioral paradigms on~     social threat attention, perception of others, and emotion regulation with high-density~     electrical neuroimaging to probe the neuro-circuitry of social threat processing in young~     adults high in perceived social isolation two hours after the oral administration of 175mg~     pregnenolone (N = 24), 400mg of pregnenolone (N = 24), or placebo (N = 24). Such research has~     the potential to yield important insights into the neurobehavioral mechanisms of pregnenolone~     on hypervigilance for social threat and perception of others--- a first key step toward the~     development of adjunctive pregnenolone therapy in individuals with PSI.~   "
56577|NCT02826434|"~     The purpose of this research study is to evaluate Immunotherapy with a peptide vaccine and~     Programmed Death Ligand 1 (PD-L1) inhibitor as a possible adjuvant treatment for Stage II or~     III Triple Negative Breast Cancer. This research study is studying the safety, tolerability,~     and immune response of these treatments.~      The names of the study interventions involved in this study are:~        -  PVX-410 Vaccine~        -  Durvalumab (MEDI4736)~   "
56568|NCT02826551|"~     Post-operative pain control following elective anterior cruciate ligament reconstruction~     continues to be a hurdle for orthopaedic surgeons. This obstacle becomes particularly~     problematic during the first 36 hours after the operation, when the patient is experiencing~     pain at its peak intensity. Good control of pain leads to better patient comfort, confidence~     to place weight on the operative limb and improved ability to perform critical exercises in~     this period to improve joint range of motion.~      A variety of anesthetic techniques have been employed to reduce pain including: cryotherapy,~     systemic analgesic and anti-inflammatory drugs, intrathecal, regional blockade of peripheral~     nerves and frequently intra-articular injections. Each technique has been studied at length~     with mixed but overall favorable results. However, in the authors' experience, after femoral~     nerve blockade, patients continue to complain of posterior knee pain in the Post-Anesthesia~     Care Unit (PACU) and peri-operative period. Intra-articular injections comprised of morphine~     and other Na-channel blocker analgesics may curb some of this pain by bathing the posterior~     capsule in anesthetic. However, there is still a large concern amongst orthopaedic surgeons~     about the potential harm these agents may have on the knee's healthy articular cartilage~     surfaces. The long term effects, including chondrolysis have been documented in the shoulder~     and while in the short term this effect is diminished there is still hesitation among~     surgeons to use this form of pain blockade.~      This has led the investigators to adapt a technique of isolated posterior capsular injections~     after total knee replacements from the joint arthroplasty literature, which has shown~     favorable results with low complication risk. The investigators plan to study the~     effectiveness of this technique during ACL reconstruction in an attempt to curb the amount of~     posterior knee pain and decrease the overall narcotic use postoperatively while limiting the~     exposure of the native cartilage to harmful agents.~   "
56569|NCT02826538|"~     Goal of this study is to evaluate the accuracy of 3D computer-planned fracture fixation with~     patient-specific instruments for clavicle, upper extremity, lower extremity and pelvis~     fractures compared with the standard procedure of fracture fixation.~   "
56570|NCT02826525|"~     This is a phase I/IIa, randomized, single-blind, placebo-controlled, multiple-ascending dose~     study conducted at a single site. The study plans to include up to approximately 46 evaluable~     subjects with Type 2 Diabetes Mellitus (HbA1c 7-11%) and Non-Alcoholic Fatty Liver disease~     (liver fat content > = 8%) on metformin monotherapy.~      Three initial cohorts are planned:~        -  Cohort 1: 6 subjects receiving AZD4076 and 4 subjects receiving placebo~        -  Cohort 2: 12 subjects receiving AZD4076 and 10 subjects receiving placebo~        -  Cohort 3: 10 subjects receiving AZD4076 and 10 subjects receiving placebo, with the~          possibility to add additional subjects if drop-out rates are higher than expected~      Pending review by SRC, an additional 2 cohorts, each consisting of 18 evaluable subjects may~     be included in the study.~      The primary objectives of this clinical trial are to investigate the safety and tolerability~     of AZD4076 following subcutaneous administration of multiple ascending doses; to assess the~     effect of AZD4076 on whole body insulin sensitivity using hyperinsulinemic euglycemic clamp~     with tracer technique; and to assess the effect of AZD4076 on liver fat content using~     magnetic resonance imaging. Secondary objectives of this trial are to characterize multiple~     dose PK of AZD4076 and its longmer and shortmer metabolites and assess the time required to~     reach steady state and the degree of accumulation; to assess the efficacy of AZD4076 on~     24-hour glucose; and to assess the effect of AZD4076 on homeostatic model assessment insulin~     resistant (HOMA-IR) and Matsuda index.~   "
56571|NCT02826512|"~     Patients with locally recurrent BRCA1-like, HER2-negative breast cancer that cannot be~     treated with curative intent by local treatment (surgery, radiotherapy +/- hyperthermia) or~     patients with metastatic BRCA1-like, HER2-negative breast cancer that have received a maximum~     of one prior line of treatment for incurable disease will be treated with Niraparib until~     disease progression~   "
56572|NCT02826499|"~     Pedicular screwing has become the gold standard for intervertebral fixation required in~     degenerative, scoliotic, tumoral pathologies or for fractures. Several pedicular screwing~     methods exist.~      The free hand pedicular screwing requires a high learning curve and has, as a consequence, a~     high malposition rate.~      The placing of pedicular screws under fluoroscopic control is the most common technique as it~     is both reproducible and accessible. It is a two dimensional imaging technique. The profile~     incidence at the level of the spine is mostly used to spot the vertebral pedicle and the~     direction of the screw in the sagittal plane. However, there is no real control of the~     direction of the pedicular screw in the horizontal or frontal plane. The screw malposition~     rate is less important than with the 'free hand' technique but remains none of the less~     significant. Furthermore, fluoroscopy is an irradiating imaging technique, both for the~     patient and the staff.~      New revolutionary techniques as the tridimensional navigation and the per-operatory~     tomodensitometry appeared in the last few years. The techniques give the best results when~     used concommitantly. The material has the advantage of being very precise. The pedicular~     screw malposition rate is minimal after a three-dimensional localisation. However, those~     systems require qualified staff and expose the patient and the nursing team to high radiation~     levels. The costs are higher and the surgery duration is globally longer. It is thus~     difficult to implement this technique in each belgian hospital.~      Finally, the Pediguard technique appeared on the market. It is a guide for the perforation of~     the pedicular channel, with a probe at its extremity. This probe allows a real time~     measurement of the electric conductivity of the tissues that are being crossed. The~     conductivity measure is translated in a sound signal. Because the cortical bone has a low~     conductivity, the probe will emit a low intensity sound signal. The cancellous bone has a~     medium conductivity. Therefore, the probe will emit a medium sound signal. However, in the~     event of a breach in the pedicular cortical, as blood and periost have a high conductibility,~     the probe will emit a intense, rapid pace, sound signal.The Pediguard technique helps thus to~     anticipate a cortical effraction, by detecting the proximity of the cortical wall. It is~     efficient but remains relatively expensive.~      The main objective of this study is to determine the precision of the placing of pedicular~     screws, with and without Pediguard system, under fluoroscopy.~   "
56573|NCT02826486|"~     This study will assess the efficacy and safety of BL-8040 as a single agent and in~     combination with pembrolizumab (Keytruda®) in subjects with metastatic pancreatic~     adenocarcinoma.~   "
56574|NCT02826473|"~     Neurocognitive Disorder (NCD) affects over 116'000 people in Switzerland and is frequently~     unrecognized and underdiagnosed. Because missed and delayed diagnosis are associated with an~     increased burden of disease health Service Research has prompted a discussion about~     diagnostic guidelines and screening programs. Some argue that screening for NCD in primary~     care is the optimal strategy to increase recognition rates; others consider test protocols~     implemented into hospital admission assessments as more justified. There is no distinct~     recommendation due to a lack of empirical data on the benefits and harms of cognitive testing~     yet. This trial strives to fill this gap and provide information about the benefits, harms~     and the economic case of routine cognitive testing for neurocognitive disorder in high risk~     elective inpatients, in Switzerland.~      The investigators hypothesize that, cognitive tested patients, compared with patients not~     cognitive tested, will have higher health-related quality of life at 12months; and lower~     medical health care costs at 18months.~   "
56575|NCT02826460|"~     A retrospective chart review in which the information in the standard psychosocial~     evaluations done pre-transplant for liver transplant recipients will be coded, recorded, and~     correlated with posttransplant outcomes of the same recipients. Evaluated outcomes include~     rejection episodes and adherence to tacrolimus, calculated through the MLVI (Medication Level~     Variability Index). The researchers will evaluate the degree to which both single elements in~     the evaluation as well as a cumulative score derived by a structured review of the chart~     using the Stanford Integrated Psychosocial Assessment for Transplantation (SIPAT) model can~     predict posttransplant outcomes.~   "
56579|NCT02826408|"~     Palpitation is a common complaint. Patients frequently feel this symptom despite having~     normal rhythm during symptoms. I have seen many patients who improve significantly on~     treatment with proton pump inhibitors (PPI). It may be that gastritis provokes a feeling of~     discomfort that subsequently starts the feeling of palpitation. On searching literature I~     found no study that investigated the effect of PPI's on palpitations. Therefore I propose a~     study where the investigators randomize people with palpitations with normal heart rate (no~     arrhythmia) and no apparent cause such as anxiety or clear illness to receive either PPI or~     placebo. The result will help to investigate if the improvement is true and if the results~     are positive this can provide a simple treatment for a common problem.~   "
56580|NCT02826395|"~     The investigators propose to conduct Carbon-11 Sodium Acetate PET/CT studies. The purpose of~     our study is to evaluate the impact of Carbon-11 Sodium Acetate PET/CT studies on patient~     management in patients with prostate cancer.~   "
56581|NCT02826382|"~     A phase 0 study to demonstrate [68Ga]P15-041 binding to bone metastases in prostate cancer~     and determination of human dosimetry.~   "
56582|NCT02826369|"~     Breast MRI is increasingly important in breast screening imaging. It is currently based on~     dynamic sequences after contrast injection whose temporal resolution must be less than 90~     seconds with dynamic acquisitions at different times.~      These curves profiles are designed to differentiate benign from malignant lesions. Recently,~     Mann et al, (2014) showed that increasing the temporal resolution of dynamic acquisitions;~     lesion enhancement curves over time were more accurate than the curves usually performed.~      It seems necessary to work on sequences having better temporal resolution without~     compromising however spatial resolution.~   "
56583|NCT02826356|"~     Specific treatments for angiotensin-converting-enzyme inhibitor (ACE-I) and~     angiotensin-receptor-blocker (ARB)-induced angioedema exist. Early access to these treatments~     is challenging because they are expensive and have short shelf lives making it illusory that~     all emergency department (ED) stock them. The aim of this retrospective study was to define,~     for each patient with a confirmed ACE-I or ARB-induced angioedema, at which step of the care,~     the specific treatment was administered. The second objective was to analyse the availability~     of these treatment in the area around Lyon, France and the factors that may influence it.~   "
56584|NCT02826343|"~     First, the investigators will image patients with hyperpolarized xenon (Xe) magnetic~     resonance imaging (MRI) to develop the technique of hyperpolarized xenon MRI at the~     University of Virginia (UVA). Magnetic Resonance (MR) sequences will need to be developed and~     optimized for the equipment at UVA. These sequences will need to be evaluated in healthy~     adults for comparison with results obtained and in adults with lung diseases to optimize the~     sequences for the detection and evaluation of lung diseases. The MR pulse sequences need to~     be optimized for the parameters of a human MR coil and the gas exchange characteristics in~     healthy and diseased lungs.~      Second, the investigators propose to exploit the power of Xe129 MRI as a diagnostic tool to~     monitor therapeutic responses of a combination inhaler, Advair, which contains a long-acting~     beta-adrenoceptor agonist (LABA) and an inhaled corticosteroid (ICS) - two major classes of~     the current COPD therapeutics. The investigators will characterize the functional changes of~     the lungs with COPD at baseline, and investigate the responses of the lungs to the treatment~     after a three-month trial. Also the investigators will compare corresponding results obtained~     by Xe129 dissolved phase (DP) MRI to the results obtained by gadolinium-based dynamic~     contrast-enhanced perfusion MRI (perfusion MRI) and high resolution computed tomography~     (HRCT) of the lung to indirectly validate the Xe129 DP MRI technique. The investigators~     anticipate that the results from this project will greatly improve the investigators~     understanding of the lung functional responses of COPD subjects to current therapeutics.~     Also, the investigators expect that this project will provide evidence to consider Xe129 MRI~     as a diagnostic strategy to assess and monitor therapeutic responses of existing and new~     pharmaceuticals, and thus Xe129 MRI will stimulate development of novel therapies for COPD in~     the future~   "
56585|NCT02826330|"~     Transversal multicentric French study on the microbiota in patients with Crohn's disease and~     their first degree healthy relatives The primary objective is the comparison of microbiota~     between patients with CD, healthy controls non genetically linked and first degree healthy~     relatives of patients with CD.~   "
56586|NCT02826317|"~     Chronic postsurgical pain (CPSP) is defined by pain persisting longer than 2 months after~     surgery (1). Its incidence varies from 10 to 50 % in the literature (2). A high proportion of~     CPSP is neuropathic (CPSNP) (4). Postoperative pain is traditionally classified as~     nociceptive pain and the more intense is this pain on a numeric pain scale (NPS), higher are~     the risks of pain chronicization and the duration of the severe pain is longer (5,6).~     However, acute neuropathic pain (ANP) can be present in the postoperative setting. However,~     data on the prevalence of ANP immediately after surgery are scarce and no screening tool has~     been validated so far in this setting. Therefore, the first objective of this multicenter~     observational study is to prospectively describe the incidence of APSNP in a large population~     using the DN4 questionnaire. The second objective of our study is to confirm the hypothetic~     link between APSNP and CPSNP at 1 and 2 months after surgery in a large population. It is~     hypothesized that the systematic use of the DN4 questionnaire in postoperative could help~     detect patients at risk of CPSNP.~   "
56587|NCT02826304|"~     The investigators compare between Vaginal Hysterectomy and Laparoscopically assisted vaginal~     hysterectomy in cases of large uteri weighing more than 280 gm regarding operative and~     Postoperative outcomes~   "
56588|NCT02826291|"~     The aim of the study is to compare one-step nucleic acid amplification method (OSNA) with~     histological ultrastaging examination in the sentinel lymph node assessment in patients with~     endometrial cancer.~      The molecular biologic method OSNA is a modern way of metastatic spread detection in~     lymphatic nodes using quantitative reverse transcription polymerase chain reaction.~     Cytokeratin 19 (CK 19) was selected based on previous studies as the optimal mRNA marker~     (detected by OSNA).~      The intraoperative identification and rapid assessment of sentinel lymph nodes by OSNA could~     help to improve the standards of care in endometrial cancer patients.~   "
56589|NCT02826278|"~     Normal values for female external genitalia size at birth, particularly clitoris and blood~     level of androgens are not well known. This study's aim is to collect normal values in 180~     newborn girls of 24 to 41 weeks of pregnancy, and to build genitalia growth charts according~     to gestational age and birth weight.~      The investigators will measure clitoris, genito-anal ratio using a small plastic caliper, at~     birth, and their evolution until Day 3 of life (if the child is still at the hospital).~      The investigators also want to establish normal values of blood testosterone,~     17-hydroxyprogesterone, delta4-androstenedione, 21-deoxycortisol, 11-deoxycortisol,~     deoxycorticosterone, corticosterone, dehydroepiandrostenedione, and dihydrotestosterone),~     using samples taken for systematic post natal screening of diseases (only in new born of 35~     or more weeks of birth).~      This is an observational prospective study.~   "
66435|NCT02697383|"~     The purpose of this study is to see what effects, good and/or bad, the combination of~     ixazomib and dexamethasone has on the patient and the smoldering multiple myeloma.~   "
56595|NCT02826200|"~     The RETORIC study is a prospective cohort study with a primary aim to assess the incidence~     and independent predictors of reduced leaflet motion and valve thrombosis after TAVI~     procedure using multimodality imaging strategy comprising cardiac CT, transesophageal~     echocardiography (TEE) and transthoracic echocardiography (TTE). As a secondary aim we will~     assess the incidence of stroke and transient ischemic attack (TIA) in patients with reduced~     leaflet motion and/or thrombosis when compared with those with normal leaflet function. In~     addition we will randomize patients with reduced leaflet motion and/or valve thrombosis to~     single antiplatelet therapy plus oral anticoagulation therapy versus standard therapy.~      The primary outcome of the nested randomized trial will be the presence of reduced leaflet~     motion and/or valve thrombosis after 4 months, the secondary outcome is the presence of~     ischemic changes in brain demonstrated by MRI.~   "
56596|NCT02826187|"~     Total replacement of hip joint is one of the most important medical innovations of the~     twentieth century. More than 100,000 hip replacements are being laid each year in France.~      Improved fixation, reduced wear rates and reduced implant dislocation rates remain subjects~     of continuous improvement.~      Hip implants cemented and cementless are part of therapeutic arsenal of orthopedic surgeons~     for joint replacement of the defective hip.~      The anchor and friction torque are both essential to the survival of hip implants. Therefore~     acetabular implants without cement with ceramic insert or polyethylene in a metalback or full~     polyethylene coated with titanium grains without metalback are proposed, but they have their~     own complications (Squeaking, fractures, recovery difficulties, difficult radiographic~     analysis, high cost for ceramics, primary stability defects, instability of the instrument~     set, Titanium residues in absence of metalback. An alternative to these implants may be an~     acetabular component without cement with polyethylene insert with an end metalback to~     increase both polyethylene thickness and size of the head in order to expect a low~     complication rate with important longevity for a lower cost.~      This study was conducted to ensure the safety and effectiveness of the acetabular implant~     POLYMAX~   "
56597|NCT02826174|"~     Penetrating keratoplasty (PKP) is an open-sky surgery that fundamentally has not changed for~     more than 100 years. Because conventional PKP is associated with the potential for the~     development of devastating complications such as expulsive suprachoroidal hemorrhage and~     endophthalmitis, we modified the technique to one that is a closed surgery under topical~     anesthesia with the anterior chamber maintained to achieve favorable results. Topical~     anesthesia is an attractive alternative to traditional injection local anesthesia since the~     potentially serious complications associated with retrobulbar and peribulbar anesthesia can~     be avoided. The closed PKP procedure with the stable anterior chamber essentially changes the~     open nature of conventional PKP. The advantages, i.e., decreased surgical risks,~     postoperative complications, and surgical difficulties, make PKP viable in most complicated~     cases.~   "
56598|NCT02826161|"~     This is an international, multi-center, prospective, randomized, open-label Phase 3 clinical~     trial of the cancer stemness inhibitor napabucasin administered with weekly paclitaxel versus~     weekly paclitaxel alone in patients with advanced non-squamous non-small cell lung cancer who~     have disease progression following systemic treatment with a platinum-based combination~     regimen in the metastatic setting, who have received treatment with an immune checkpoint~     inhibitor if a candidate, additional approved therapies, and for whom weekly paclitaxel is an~     acceptable treatment option.~   "
56599|NCT02826148|"~     The diagnosis of developmental disorders in adults is still difficult. Indeed, in France,~     there is not questionnaires to easily and accurately diagnose this disorder. Several~     diagnostic scales were developed in English. Among them, RAADS-R scale, which is a clinical~     tool that aims to better identify autism spectrum disorders including mild forms in adult~     people and help to diagnose of high-functioning autism . The objective of this study is to~     perform a complete validation of this scale in the french version.~   "
56600|NCT02826135|"~     The purpose of this study is to evaluate predictability of an abdominal compression-induced~     change of blood pressure for fluid responsiveness in children with single ventricle~     (bidirectional cavopulmonary shunt and Fontan tract).~   "
56601|NCT02826122|"~     The Purpose of this study is to 1) investigate prevalence of diastolic dysfunction in~     patients with morbid obesity attending a conservative lifestyle change program, 2)~     investigate effects on cardiac function, cardiorespiratory Fitness, body composition, quality~     of life and cardiovascular risk through the program, 3) investigate feasibility of~     introducing two different activity monitors throughout the program, and 4) comparing~     compliance to activity sensor market leader FitBit Application versus Mio Pai Application~   "
56602|NCT02826109|"~     Periodontal disease is a gum infection caused by plaque on teeth containing both bacteria and~     calculus (hard) deposits. These need to be removed on a regular basis to maintain gum health~     and to prevent teeth weakening. A routine cleaning procedure, scaling/root planing, is~     accompanied with post-operative soft tissue tenderness and teeth sensitivity making oral~     hygiene maintenance difficult during wound healing. The need for novel therapeutic~     approaches, such as cyanoacrylate adhesives, has been identified. It has been hypothesized~     that its application may provide comfort and assist patients with their daily oral self-care~     procedures following teeth cleaning.~   "
56603|NCT02826096|"~     The study is to examine the therapeutic effect of a brief version of biofeedback therapy~     (developed bu the research team) on panic disorder. It is a randomized controlled design. The~     severity of panic symptoms of two groups of panic patients (reveiving biofeedback therapy or~     not) were measured before and after the six week duration. Besides, the severity of anxiety,~     depressive, somatic symptoms, and physiological indexes were recorded.~   "
56604|NCT02826083|"~     Given preliminary data in animal (proprietary data) have shown that XXS (a mixture of natural~     polyphenolic extracts of edible plants) has a significant and favourable effect on oxidative~     stress notably with a decrease in certain markers of oxidative stress and on plasma lipid~     parameters, the investigator proposes to study the effect of 6 months of treatment with XXS~     in a controlled study against placebo in a population of persons presenting a lipid profile~     at the upper limit of normal.~   "
56605|NCT02826070|"~     The purpose of this study is to demonstrate that long-term treatment (up to six years) with~     telbivudine or telbivudine plus adefovir results in the regression in liver inflammation and~     fibrosis/cirrhosis.~   "
96042|NCT02310035|"~     Blood sampled for standard evaluation will be used for determination of plasma glutamine by~     Bioprofile Flex Glutamine Sensor at ICU admission~   "
56606|NCT02826057|"~     This study includes comatose survivors of out-of-hospital cardiac arrest treated with 24~     hours or 48 hours of targeted temperature management.~      The overall aim is to evaluate the importance of plasma complement protein concentrations in~     patients resuscitated after out-of-hospital cardiac arrest and treated with 24 hours or 48~     hours of targeted temperature management.~      The specific aim is to evaluate:~        -  the concentration of plasma lectin pathway proteins the first, second and third day~          after cardiac arrest~        -  the relation between concentration of plasma lectin pathway proteins and mortality~        -  if prolonged targeted temperature management influences the concentration of plasma~          lectin pathway proteins~      This study is a sub-study to the trial entitled: Time-differentiated targeted temperature~     management (TTH48) (ClinicalTrials.gov Identifier: NCT01689077)~      The following Complement Lectin Pathway proteins will be measured: Mannan-Binding-Lectin,~     M-ficolin, H-ficolin, CL-L1, MASP-1, MASP-2, MASP-3, MAp19 and MAp44.~   "
56607|NCT02826044|"~     SP2086 is a novel inhibitor of Dipeptide base peptidase 4, allows an insulin-independent~     approach to improve type 2 diabetes hyperglycemia. In this single-dose and multiple-dose~     study the investigators evaluated the safety, tolerability and Pharmacokinetics profiles of~     SP2086 in healthy volunteers.~   "
56608|NCT02826031|"~     This is a multi-center, randomized, open-label, parallel-arm phase IV clinical study, for~     which a total of 300 patients with mild to moderate knee osteoarthritis will be enrolled. In~     the first 4 weeks (run-in period), the subjects will receive on-demand treatment with~     Diclofenac Sodium Sustained Release Tablets (DICL-SR) 75mg, quaque die（QD）. After the run-in~     period, the subjects, if their knee pain has not worsened to a level requiring surgical~     treatment, will be randomized to two groups in 1:1 ratio: one group receiving Artz® via~     intra-articular injection (once weekly, for 5 consecutive weeks) in combination with DICL-SR~     75mg,quaque die（QD）, for 12 consecutive weeks on demand. The other group receiving DICL-SR~     75mg alone,quaque die（QD）, for 12 consecutive weeks on demand. DICL-SR 75mg quaque die（QD）~     may be administered to the subjects of both groups on demand as long as they have a knee~     pain. If the knee pain has disappeared, this drug may be withdrawn. However, if the pain~     occurs again and requires treatment, oral administration of DICL-SR may be resumed. A subject~     is allowed to withdraw from this study prematurely if unable to tolerate the adverse effects.~      A total of 8 visits have been scheduled for this study, including Visit 1/screening period~     (Week -4), Visit 2/baseline (Week 0), Visit 3 (Week 1), Visit 4 (Week 2), Visit 5 (Week 3),~     Visit 6 (Week 4), Visit 7 (Week 8) and Visit 8 (Week 12).~      A total of 300 subjects will participate in this study at 6 to 8 centers in China, and~     patient enrollment is expected to take up to 12 months.~   "
56609|NCT02826018|"~     The purpose of this study is to determine the safety, tolerability and pharmacokinetics of~     ALN-HBV in healthy adult volunteers and patients with chronic hepatitis B virus (HBV)~     infection. In addition, the study will assess antiviral efficacy of ALN-HBV in patients with~     HBV.~   "
56610|NCT02826005|"~     Examination the ability to early diagnose HCC by combining three biomarkers technology~     developed by WAKO, And their relevance to cirrhotic of patients with various backgrounds and~     the Israeli population.~      This blood test will serve as an additional diagnostic tool tools currently in use~     (Ultrasound and AFP levels) to cirrhotic patients with high risk to develop hepatocellular~     carcinoma.~      Another group that will be examined for all three biomarkers will be patients which already~     diagnosed with hepatocellular carcinoma, and have normal AFP level in order to examine the~     correlation between the presence of tumor, the number of them and the tumor size and the~     three biomarkers concentration in their blood~   "
56611|NCT02825992|"~     Post Market Clinical Follow-up Study designed to evaluate the incidence of device- and~     procedure-related safety, efficacy, and efficiency (6 and 12 month outcomes) when using the~     AcQMap™ as an imaging and mapping system for ablation of persistent atrial fibrillation (AF).~   "
56612|NCT02825979|"~     The EARLY-AF study is centered on an evaluation of the impact of the early invasive~     management of Atrial Fibrillation. The primary goal of the study is to evaluate the clinical~     effectiveness of an early invasive approach. Specifically, the investigators are aiming to~     evaluate if PVI performed with the Arctic Front cryoballoon is superior to AAD as first-line~     therapy in preventing atrial arrhythmia recurrences (arrhythmia related symptoms,~     hospitalisations, and health care utilization).~   "
56613|NCT02825966|"~     A prospective, validation study to evaluate the data accuracy of heart sounds recorded by the~     LifeVest® Wearable Cardioverter Defibrillator (WCD). These data will be compared with the~     heart sounds data recorded by an FDA-cleared device.~   "
56614|NCT02825953|"~     The present study was designed to evaluate, in premature babies with RDS breathing~     spontaneously, the efficacy of combined treatment with nasal continuous positive airway~     pressure (CPAP) and aerosolized surfactant. The first objective of investigators is to assess~     the safety of surfactant nebulization in this clinical situation, and to ﬁnd out whether~     treatment with aerosolized surfactant would reduce the need for mechanical ventilation. And~     other aim suggest that aerosolized dates compared with dates of INSURE~     (intubation-surfactant-extubation) and minimally invasive surfactant therapy (MIST) method.~   "
56615|NCT02825940|"~     This Phase I, open-label, multicenter study will evaluate the pharmacokinetics, safety, and~     preliminary anti-tumor activity of atezolizumab as monotherapy in Chinese participants with~     locally advanced or metastatic gastric cancer, nasopharyngeal cancer, esophageal cancer, and~     hepatocellular carcinoma (HCC) that are refractory to standard therapeutic modalities and for~     whom no further standard therapy is available or who have refused standard therapy; and the~     safety and preliminary anti-tumor activity of atezolizumab in combination with gemcitabine~     and cisplatin in Chinese participants with Stage IV, treatment-naive non−small cell lung~     cancer (NSCLC). The study will consist of a pharmacokinetic (PK) phase and an extension~     phase.~   "
56616|NCT02825927|"~     The purpose of this study is to determine whether a specific rehabilitation program with oral~     screen used in an elderly population with dysphagia can improve elderly's swallowing~     capacity.~   "
56690|NCT02824965|"~     This will be a Phase Ib open-label trial of CAVATAK™ (CVA21) in combination with~     Pembrolizumab for the treatment of patients with advanced NSCLC. The dose of Pembrolizumab~     will be fixed at 200mg. Three cohorts (dose levels) of intravenously-delivered CVA21 will be~     explored, using a standard 3+3 patient dose escalation design. The starting dose of CVA21~     will be one log below the 1 x 10^9 TCID50 dose found to be safe when CVA21 was given alone in~     an ongoing Phase I study (NCT02043665).~   "
56617|NCT02825914|"~     Casein glycomacropeptide (CGMP) has anti-inflammatory properties in experimental rodent~     colitis and using human in vitro inflammation models. Its use as a food ingredient has proven~     safe and with no influence on dietary intake. In a pilot study the investigators found, that~     orally administered CGMP seems to have a beneficial effect comparable to that of mesalazine~     in active distal ulcerative colitis.~      The investigators wish to evaluate the effects in a larger group of patients with active~     ulcerative colitis by studying the clinical effects and assessing the anti-inflammatory and~     microbiome modulating properties.~   "
56618|NCT02825901|"~     The purpose of the trial is to evaluate the effect of Djulis-Buckwheat drink on~     cardiovascular protection after ingesting for 8 weeks. In addition, the correlation between~     the supplement and the cardiovascular disease-related gene expression is evaluated. The~     results will be used for the application of functional products for cardiovascular~     protection.~      Ninety subjects (age 30~65) with Prehypertension or Hypertension stage 1 will be included and~     randomly allocated into 3 groups: Placebo, Djulis-Buckwheat and Buckwheat. The subjects will~     take sample (100 ml/day) for 8 weeks. Blood pressure will be measured on week 0, 1, 2, 4, 6~     and 8. The blood biochemical parameters and gene expression analysis will be examined on week~     2, 4, 6, 8 and 10 (the follow up).~   "
56619|NCT02825888|"~     Title of Research Program: Ultrasound Guided Axillary Brachial Plexus Block: Influence of~     Obesity on Block Failure Rate, Performance Time and Incidence of Acute Complications- A~     prospective observational cohort study~      Background: Axillary brachial plexus (ABP) block is commonly performed as the primary~     anesthetic technique to provide surgical anesthesia and postoperative analgesia for elbow,~     forearm and hand surgery. Compared to general anesthesia, ABP blocks have been shown to~     result in better pain relief, less nausea and vomiting, shortened length of hospital stay,~     decreased side effects of opioids painkillers and better patient satisfaction. These~     beneficial effects of ABP blocks are particularly useful for patients who are overweight or~     obese as this cohort is at a higher risk of experiencing complications from general~     anesthesia. Traditionally, nerve blocks have been described technically challenging in obese~     patients. This may not be true now with availability of high-resolution ultrasonography (US).~     US imaging also allows doctors the ability to visualize the needle live to allow for more~     accurate needle placement. This allows local anesthetic to be placed more precisely resulting~     in faster onset anesthesia, decreased local anesthetic drug dosages, reduced complications~     and higher success rate. Ultrasound guidance has not been used for performing ABP block in~     previous studies in obese patients.~      Hypothesis: We hypothesize that the block failure rate is no worse in obese compared to~     non-obese patients when US guidance is used to perform ABP blocks.~      Specific Objectives: The primary objective of this study is to evaluate whether obese~     patients receiving US guided ABP block as their primary anesthetic modality have a block~     success rate (defined by a Composite Score ≥ 14 at 30 minutes) worse than their non-obese~     peers. The secondary objective is to evaluate time parameters around ABP performance,~     incidence of complications and patient satisfaction.~      Methods: This study will be conducted as an observational quasi-experimental multicenter~     trial at St. Joseph's Health Care (SJHC), London, ON and the Nova Scotia Health Authority~     (NSHA) Halifax Infirmary (HI) site, Halifax NS. There will be 250 patients taking part in~     this study. One hundred and fifty patients have already completed the study in Ontario. The~     duration of the study at the Halifax Infirmary is 10 months. Healthy patients (aged 18-75~     years) scheduled to undergo elbow/ forearm/ or hand surgery will be invited to volunteer in~     this observational study. A study investigator or resident under direction supervision of a~     study investigator will perform the ABP block. There is NO experimental drug or treatment in~     this study. Patient demographics including age, sex, arm circumference, height, weight and~     Body Mass Index will be recorded. Nerve blocks will be performed in a designated area near~     operating rooms called the block room. US will be used for identification of the nerves~     supplying the arm and an ABP block will be performed with a total volume of 30 mL of 0.5%~     ropivacaine according to a standardized procedure. Measurements of sensory and motor blockage~     will be recorded every 5 minutes for 30 minutes following the ABP block. Block success will~     be measured and is defined as a score of ≥ 14 on the Composite Score (CS) within 30 minutes~     of ABP block completion. According to routine care, all patients will receive a phone call~     from the investigators 24-48 hours after surgery to inquire about complications. The study~     follows non-inferiority design to show that the success rate in the obese group is not worse~     than the non-obese when anesthetized. In non-inferiority trials, both intention to treat and~     per-protocol analysis are recommended; both approaches should support non-inferiority The~     student's t-test (unpaired, two tailed) will be used for comparison of the means of~     continuous, normally distributed data or Mann-Whitney U test as appropriate. Categorical data~     (success rate, complication rate) are to be analyzed using χ2 test or Fisher's exact test, as~     appropriate. An interim analysis will not be conducted and set at 0.05 for significance and~     95% confidence intervals.~      Significance/ Importance: This study would provide anesthesiologists additional information~     to inform their clinical decision-making when dealing with obese patients. To date there are~     no publications or any registered trials exploring the success rates and technical aspects of~     ABP blockade in obese patients using US guidance technology for block performance. Therefore,~     this study is novel and timely for the patient groups.~   "
56620|NCT02825875|"~     In this study we aim to more precisely define the clinical utility of PSMA imaging across a~     range of clinical indications in men with prostate cancer. To accomplish this, we will make~     the 18F-DCFPyL PET/CT scan available to urologists, medical oncologists, and radiation~     oncologists at Johns Hopkins and survey physicians as to the indication for ordering the~     PET/CT and if a change in management occurred as the result of new information gained from~     the scan. We believe these data will prove critical for planning future studies aimed at~     evaluating the efficacy of this test for improving patient outcomes.~   "
56621|NCT02825862|"~     The investigators aim to experimentally manipulate presence of questions on positive or~     negative affective attitudes to see if including these moderate as intention to become an~     organ donor. The methodology will be replicated across three international sites (RCSI~     Dublin, RCSI Bahrain, RCSI Perdana University).~   "
56622|NCT02825849|"~     Patients with intrauterine adhesions (Asherman's Syndrome) and persistent thin endometrial~     lining in in vitro fertilization (IVF) treatment programs, particularly those resistant to~     standard therapies, present a significant clinical challenge. The aim of this trial is to~     assess if intrauterine administration of platelet rich plasma (PRP) improves endometrial~     lining thickness in patients with thin lining or Asherman's Syndrome.~   "
56623|NCT02825836|"~     M7583 is an investigational drug that is being evaluated for the treatment of patients with~     B-cell malignancies, which are cancers that form in B cells (cells that are part of the~     immune system). This study has been designed to assess the use of the study drug in patients~     with B-cell lymphomas who have tried and did not respond well (or the B-cell lymphoma came~     back) to at least one but not more than three types of treatment for cancer. This is a Phase~     I/II study, which means that it is looking at several dose levels of an investigational~     medication in terms of its safety and how well it is tolerated in multiple doses. The final~     selected dose will be tested for activity against the tumor in specific populations of~     lymphoma (Mantle cell lymphoma and Diffuse Large B Cell Lymphoma)~   "
56624|NCT02825823|"~     The ketone body beta-hydroxybutyrate is produced during prolonged fasting or exercise and can~     be used as an alternative fuel source. Exogenous beta-hydroxybutyrate, in the form of a~     ketone salt, is proposed to have ergogenic potential for high-intensity exercise performance~     but this has not been adequately studied. The purpose of this study is to determine whether~     supplementing with an acute dose of ketone salts can alter fuel use during exercise and~     improve exercise performance.~   "
56625|NCT02825810|"~     The aim of this study will be to determine the effectiveness of a physical therapy program~     which is based on cervical motor control exercises in long-term breast cancer survivors in~     order to improve their motor control and its possible impact on pain, mood state and quality~     of life.~   "
56626|NCT02825797|"~     This is a phase 1b clinical trial to evaluate the safety, pharmacokinetics and the~     antiretroviral effects of the combination of two anti-human immunodeficiency virus (HIV)~     broadly neutralizing antibodies, 3BNC117 and 10-1074, administered intravenously in~     HIV-infected individuals. This study is intended to support the development of the~     combination of 3BNC117 and 10-1074 mAbs for use in the treatment of HIV-1 infection.~   "
56627|NCT02825784|"~     A multicenter, open label, uncontrolled study to evaluate the acceptability, tolerability,~     and nutritional suitability of a medical food (Renastart, Vitaflo International Ltd)~     specially formulated to meet the unique nutritional needs of children from birth to 10 years~     with chronic kidney disease (CKD)~   "
56628|NCT02825771|"~     Suicide is the second leading cause of death for American Indians and Alaska Natives aged~     18-34 years. This study will evaluate Caring Contacts, a low-cost, sustainable intervention~     for suicide prevention that sends caring text messages to people at risk. The investigators~     will implement the intervention at four tribal sites, leveraging community strengths and~     values to address this tragic health disparity in an underserved minority population.~   "
56629|NCT02825758|"~     A study to evaluate the acceptability of ZestiVits; a new vitamin, mineral and trace element~     supplement for children aged 11 years and over and adults on a ketogenic or restricted~     therapeutic diet with regard to product tolerance, palatability and compliance.~   "
56630|NCT02825745|"~     In brief, this research is a prospective, feasibility study to evaluate the use of Betashot-~     a medium chain triglyceride- based (MCT) food for special medical purposes (FSMP) in children~     and adults diagnosed with epilepsy.~      MCT is a type of dietary fat used in the ketogenic diet.~   "
56631|NCT02825732|"~     The investigators will investigate which patients' characteristics are associated with~     caregivers burden and its evolution for outpatients visiting a memory clinic, in particular~     how functional autonomy, behavioral and psychological symptoms as well as patients~     comorbidities can influence caregiver burden.~      The study will be conducted among outpatients with progressive cognitive complaint followed~     in a Memory Clinic and their primary caregiver. The investigators hypothesis that caregivers~     experience a higher burden due to disease symptoms such as impairment of functional autonomy,~     behavioral and cognitive impairment, whatever the aetiology of the cognitive decline.~   "
56632|NCT02825719|"~     Uterine leiomyomas is the commonest benign tumour of the female genital tract. It lead to~     menorrhagia, anaemia, pain and pressure symptoms. Due to the enlarged uterus, the use of~     minimal invasive surgery is limited. There is also increase risk of intraoperative blood~     transfusion. Ulipristal acetate (UPA) is a selective progesterone-receptor modulator (SPRM).~     Preoperative use of Ulipristal for 12 weeks has been shown to decrease uterine bleeding,~     fibroid volume, pre-operative anaemia and symptoms severity. However there is still lacking~     evidence in terms of long term safety and efficacy, especially in Chinese population. The aim~     of the present study is to evaluate the effect and safety on preoperative use of Ulipristal~     on fibroid.~   "
56633|NCT02825706|"~     Although arthropathy is a serious problem in patients with hemophilia due to the associated~     morbidity and incapacity, to the best of the investigators knowledge, no studies have looked~     at the effect of educational physiotherapy for its clinical improvement.~      This contribution presents the results of educational physiotherapy program applied for 15~     weeks with home exercises - in patients with hemophilic arthropathy. After treatment,~     experimental group showed improved a significant reduction of pain, and best quality of life~     al illness behaviour. During treatment no patient showed elbow haemarthrosis, which~     underlines the safety of this physiotherapy program.~   "
56634|NCT02825693|"~     This study aims to examine the health economic impact of adopting femtosecond laser~     technology to assist high volume cataract surgery (FLACS) within a state-funded healthcare~     system, the National Health Service (NHS).~   "
56635|NCT02825680|"~     The overall goal of this project is to test whether the Learn. Engage. Act. Process (LEAP)~     intervention helps teams within the Veterans Health Administration's local MOVE! group weight~     management programs be more in line with guidance. Forty-eight sites will be randomized to~     the LEAP intervention, which is a virtually delivered program that relies on the IHI Model~     for Improvement, an online learning platform for clinician teams to share ideas and progress,~     an audit and feedback process, and a barrier buster tool. The LEAP intervention will be~     compared to active support that is provided to all VA MOVE! programs by the National Center~     for Health Promotion and Disease Prevention (NCP). The investigators will compare whether~     participation in LEAP results in engaging more Veterans in the MOVE! weight management~     program compared to facilities not participating in LEAP. The investigators will also collect~     information to understand what components of LEAP worked best and how to scale up so more~     teams can participate in LEAP.~   "
56636|NCT02825667|"~     Randomized clinical trial to assess the efficacy of a treatment protocol applied fascial~     therapy in patients with hemophilic arthropathy ankle, oriented to know and describe the~     observed differences on the dependent variables: range of motion, pain and physical~     condition.~      At the same time, the study will determine whether there are adverse effects or bleeding~     complications as a result of applied physiotherapy treatment.~   "
56637|NCT02825654|"~     The purpose of the study is to better understand the health, including lung health, of~     Veterans who deployed in support of Operation Enduring Freedom (OEF), Operation Iraqi Freedom~     (OIF), or Operation New Dawn (OND) and other deployments following these Operations.~   "
56638|NCT02825641|"~     The study is intended to compare expectant management and on presentation labor induction in~     women with premature rupture of membranes.~      The means of labor induction and cervical ripening are either oxytocin or dinoprostone.~      Expectant management in this obstetrical state means waiting 24 hours from the onset of~     rupture of membranes and then commencing labor induction with either oxytocin or dinoprostone~     depending on the patient`s obstetrical history and cervical condition.~      The investigators` hypothesis is that active management will lead to a higher rate of vaginal~     deliveries, a shorter interval between the time of rupture of membranes and the time of~     delivery, a lower rate of cesarean sections and a better obstetric result for the mother and~     the fetus/newborn.~   "
56639|NCT02825628|"~     This is a phase II randomised, double-blind, dose finding, repeat dose Phase II multicentre~     study of ODX for the treatment of patients with castration resistant prostate cancer (CRPC)~     and skeletal metastases.~      The primary objective is to evaluate the relative change from baseline in response markers~     related to bone metabolism (alkaline phosphatase (B-ALP) and S P1NP) at 12 weeks of three~     different doses of ODX (3.0, 6.0 and 9.0 mg/kg ODX).~   "
56640|NCT02825615|"~     Purpose Two techniques of radial artery cannulation, ultrasound guided (USG) and conventional~     method (CM) were compared to find the better technique in general and in different~     hemodynamic subsets of patients.~      Method This is a prospective randomized, single center study of 100 patients. The details of~     the primary cannulation technique, number of attempts, time taken, failure and cross-over~     technique were recorded for three different hemodynamic subsets with Systolic blood pressure~     <80 mm hg, 80-100 mm hg and > 100 mm hg.~   "
56641|NCT02825602|"~     The Vietnam Era Health Retrospective Observational Study (VE-HEROeS) is a national study on~     the health and well-being of Vietnam Veterans, including Blue Water Navy Veterans, as well as~     Veterans who served elsewhere during the Vietnam Era (1961-1975), and similarly aged U.S.~     residents who never served in the military. The investigators will invite approximately~     43,000 Vietnam and Vietnam Era Veterans, and approximately 11,000 members of the general U.S.~     population to participate in VE-HEROeS. These individuals are scientifically selected to~     participate; the study is not able to accept volunteers.~      All participants in VE-HEROeS will be asked to fill out a questionnaire on their military~     service, general health, age-related conditions, health care use, and the health experiences~     of their children and grandchildren. A smaller group will be asked to provide the~     investigators with access to some of their medical records. Topics of special focus for the~     study include cognition, hepatitis C infection, and neurologic conditions.~   "
56658|NCT02825381|"~     The primary goal of the study is to evaluate the success rate of routine one-stage exchange~     for treatment of chronically infected total hip arthroplasty performed at the investigators~     institution, and to compare it to the current literature reporting success rate of selected~     one-stage exchange procedure or two-stage procedure.~      The secondary goal is to detect the potential prognostic factors and potential selection~     criteria which may influence the success rate. The tested hypothesis is following: the~     success rate of routine one-stage exchange is lower than that of selected one-stage or~     two-stage procedure~   "
56659|NCT02825368|"~     The purpose of the study is to compare the immunological response of homeopathic vaccines to~     placebo and to conventional vaccines in healthy young adults.~   "
56642|NCT02825589|"~     Based on many previous data proving hypervolemia in chronic hemodialysis patients could lead~     to sleep apnea and poor sleep quality. The investigators conduct this trial to evaluate~     whether more accurate dry weight assessment with BIA in these patients can lead to better~     sleep quality (measured by sleep actigraphy and questionnaires). The investigators will~     enroll 30 chronic hemodialysis patients in hemodialysis unit of Ramathibodi hospital whose~     age > 18 years with subclinical hypervolemic status and baseline Pittsburgh sleep quality~     index (PSQI) score > 5 into study. Patients with bed-ridden status, alteration of~     consciousness and unstable hemodynamics will be excluded. Then eligible patients will be~     randomized into 2 groups, BIA-guided and standard clinical guided dry weight assessment. The~     investigators will assess participants' dry weight at beginning of study, 3rd month and 6th~     month. Sleep actigraphy parameters (eg. total sleep time, sleep efficiency), sleep~     questionnaires score, left ventricular mass index by echocardiography, ambulatory blood~     pressure monitoring and blood chemistry results were collected at beginning of study, the end~     of 1st, 3rd and 6th month. The primary outcome is change of sleep actigraphy parameters~     between the groups. The secondary outcomes are change of sleep questionnaires scores, change~     of left ventricular mass index, change of ambulatory BP monitoring and also cardiovascular~     complications between groups.~   "
56643|NCT02825576|"~     The purpose of this study is to determine if the use of sugammadex (compared with~     neostigmine) reduces the rate of postoperative pulmonary complications (PPCs).~   "
56644|NCT02825563|"~     The purpose of this study is to further study the pharmacokinetic characteristics of~     Anlotinib in Advanced Cancer Patients with High Fat Diet.~   "
56645|NCT02825550|"~     The purpose of this study is to evaluate the safety and efficacy of Radiopaque Microsphere~     (T-ACE Beads) interventional therapy for liver cancer~   "
56646|NCT02825537|"~     The main objective of this study is to compare precisely, under standardized test conditions,~     water balance changes in healthy subjects with or without the daytime use of compression~     stocking.~   "
56647|NCT02825524|"~     The purpose of the study is to assess the efficacy and morbidity of biliairy radiofrequency~     ablation for the treatment of dysplastic endobiliairy residual lesions (low-grade dysplasia~     or high-grade dysplasia) after endoscopic ampullectomy for ampullary adenoma.~   "
56648|NCT02825511|"~     Assessment of the concordance of the initial clinical and histological diagnosis and to~     explore its prognostic impact in terms of risk of recurrence.~   "
56649|NCT02825498|"~     Radiofrequency ablation (RFA) is a standard treatment option for cavotricuspid isthmus (CTI)~     dependent atrial flutter. We plan to perform a randomized prospective trial comparing the~     efficacy of contact force (CF) guided CTI ablation against catheter ablation with the~     operator blinded to contact force parameters.~   "
56650|NCT02825485|"~     It has previously been found that there is no correlation between degree of hydronephrosis~     and presence of reflux; however this is oftentimes the criteria physicians use to obtain a~     VCUG.~   "
56651|NCT02825472|"~     Rationale: Regular physical activity and aerobic exercise training are related to decreased~     cardiovascular mortality in healthy individuals, as well as in individuals with~     cardiovascular risk factors and cardiac patients. Unfortunately, no such data is available on~     exercise training in adult patients with congenital heart disease.~      Objective: The objective of the ExTra GUCH trial is to assess whether encouragement of a~     six-month sports participation program in addition to usual care in symptomatic adult~     patients with congenital heart disease improves exercise capacity and quality of life, and~     lowers serum N-terminal prohormone brain natriuretic peptide (NT-proBNP) levels.~      Study design: International, multi-centre parallel randomized controlled trial.~      Study population: Adult patients with congenital heart disease, who are in New York Heart~     Association (NYHA) class II or III.~      Intervention (if applicable): The intervention group receives a six-month individualized~     exercise training program, the control group receives usual care.~      Main study parameters/endpoints: The primary outcome is the change in peakVO2 between~     patients in the sports participation group, and the control group. Secondary outcome measures~     are change in NYHA functional class, quality of life, and NT-proBNP levels. The primary~     safety outcome is the composite of all hospitalizations, and all deaths during, or within~     three hours after exercise. The secondary safety outcome is the composite of all exercise~     related injuries for which medical attention is sought.~   "
56652|NCT02825459|"~     The purpose of this study is to see whether adults who use e-cigarettes every day experience~     symptoms of nicotine withdrawal when they stop using e-cigarettes for 6 days.~   "
56653|NCT02825446|"~     Angioplasty augmented radiofrequency denervation popliteal artery, in our opinion, will~     remove the spasm with macro and microcirculatory blood flow, which increases~     revascularization patency of tibial arteries.~   "
56654|NCT02825433|"~     The ventilation (respiratory rate, tidal volume and end-tidal CO2) was monitored for patients~     receiving procedural sedation during endoscopy procedures in order to observe what changes~     commonly occur.~   "
56655|NCT02825420|"~     Non-interventional, multicenter, prospective, European study to describe the effectiveness of~     trabectedin + PLD in the treatment of relapsed ovarian cancer (ROC) patients according to~     SmPC regardless of previous use of an antiangiogenic drug~   "
56656|NCT02825407|"~     There are few data on elderly people concerning mechanisms involved in the in vivo release~     and perception of aromatic compounds. Any knowledge on this point would be of great interest~     to the scientific community. Concerning the dimensions of sensory perception and in-mouth~     comfort, there is, to our knowledge, no methodology to describe them. These dimensions are~     truly original and innovative, and investigating them will lead to the development of foods~     adapted to elderly populations with chewing and salivation disorders.~      The expected results are:~        -  to obtain two groups of subjects with differences in chewing abilities and saliva~          production~        -  the characterization of flavour release profiles in elderly subjects with regard to oral~          physiology (mastication and salivation) and saliva composition~        -  a sensory profile describing in-mouth comfort when food is eaten~   "
56657|NCT02825394|"~     The investigators study aims to test the correlation between the Cascade Abrazo point-of-care~     testing (POCT) device (Helena Laboratories, USA) and plasma levels of apixaban, dabigatran,~     edoxaban and rivaroxaban, and to determine the diagnostic accuracy of POCT to rule out or~     detect relevant levels of direct oral anticoagulants (DOAC) in real-life patients.~   "
56661|NCT02825342|"~     Non cardiac chest pain (NCCP) is defined as recurring, angina-like, retrosternal chest pain~     of non cardiac origin. Annual prevalence of NCCP in the general population of the western~     world ranges from 25-35%. Of those patients presenting to an emergency room with chest pain,~     a cardiac etiology is ultimately found in only 11-39%. Several conditions are associated with~     NCCP, with gastroesophageal reflux disease (GERD) being the most prevalent, constituting up~     to 60% of cases. However, NCCP is considered a disorder of heterogenous nature and several~     other conditions, apart of GERD, such as esophageal dysmotility and esophageal~     hypersensitivity have been implicated.~      Treatment of NCCP remains a real challenge due to the diverse underlying mechanisms~     responsible for patients' symptoms. Given the fact that GERD is by far the most common~     etiology, proton pump inhibitor (PPI) therapy has been tried extensively; however, after 6~     weeks of treatment complete resolution of symptoms occurs in only 30% of patients, the~     optimal duration of PPI administration is not known, while the best maintenance dose has~     never been determined. Although the administration of selective serotonin reuptake inhibitors~     (SSRIs) could theoretically benefit those patients with esophageal hypersensitivity, the~     trials that have been published so far have included small number of patients and reported~     conflicting results, while the co-administration of PPIs with SSRIs has not been evaluated so~     far. Furthermore, data on treatment of patients with functional chest pain are lacking.~   "
56662|NCT02825329|"~     Open-label, non-controlled study of standard care plus the TORAYMYXIN PMX-20R (PMX cartridge)~     in subjects who have endotoxemia and septic shock. This is a continued access study~     subsequent to the EUPHRATES clinical trial NCT01046669.~   "
56663|NCT02825316|"~     This clinical study is designed to evaluate the effect of Mediterranean diet as an add-on~     therapy for induction of remission in adult patients with active Crohn's disease and to~     evaluate its effects on clinical, inflammatory and microbial parameters.~   "
56664|NCT02825303|"~     Prolonged sitting is a risk factor for cardiovascular and musculoskeletal diseases, diabetes,~     several types of cancer and all-cause mortality. In combination with static and awkward~     postures, the prevalence of musculoskeletal diseases can increase further. Although the~     implementation of sit-to-stand or active workstations can help to reduce sitting time,~     improve physical activity at work and promote health benefits, it might also lead to changes~     in cognitive functions such as productivity The purpose of this study is to evaluate the~     mid-term effect of a novel two desk sit-to-stand workplace on sitting time as well as~     physiological and cognitive parameters for healthy people of working age in comparison to~     their traditional workplace.~   "
56665|NCT02825290|"~     This study evaluates the outcomes of frozen-thawed embryo transfer (FET) success rate with~     modified luteal support - addition of a single injection of HCG and GnRH-agonist, on day of~     ET and 4 days later, respectively vs. traditional luteal support with vaginal progesterone~     only in ovulating women.~   "
56666|NCT02825277|"~     Introduction~      Preeclampsia (PE) and intra-uterine growth restriction (IUGR) are two major pregnancy~     complications related to chronic utero-placental hypoperfusion. Three-dimensional power~     Doppler (3DPD) angiography has been used for the evaluation of utero-placental~     vascularisation and three vascular indices have been calculated: the vascularisation index~     (VI), flow index (FI) and vascularisation-FI (VFI). However, several technical endpoints~     hinder the clinical use of 3DPD as physical characteristics and machine settings may affect~     3DPD indices, and so its clinical significance is not yet clear.~      Objectives~      The primary objective is to better understand the clinical significance of 3DPD indices by~     evaluating the relationship between these indices and placental morphometry. Secondary~     objectives are (i) to determine the impact of machine settings and physical characteristics~     on 3DPD indices, and (ii) to evaluate physio-pathological placental vascularisation patterns.~      Methods and analysis~      This is a prospective controlled study. We expect to include 112 women: 84 with normal~     pregnancies and 28 with PE and/or IUGR (based on our former cohort study on 3DPD indices for~     PE and/or IUGR prediction (unpublished data)). Within 72 h before planned or semi-urgent~     caesarean section, utero-placental 3DPD images with five different machine settings will be~     acquired. Placentas will be collected and examined after surgery and stereological indices~     (volume density, surface density, length density) calculated. The 3DPD indices (VI, FI and~     VFI) of the placenta and adjacent myometrium will be calculated. Correlation between Doppler~     and morphological indices will be evaluated by Pearson or Spearman tests. Agreement between~     3DPD indices and morphological indices will be assessed by Bland and Altman plots. The impact~     of Doppler settings and maternal characteristics on 3DPD indices will be evaluated with a~     multivariate linear regression model.~   "
56667|NCT02825264|"~     STARflo is a novel suprachoroidal Glaucoma Drainage Device (GDD), bleb-free, exhibiting~     anti-fibrotic properties. Release of this CE Marked implant has been limited to leading~     Glaucoma Centers in Europe.~   "
56668|NCT02825251|"~     This trial is conducted in Europe and the United States of America (USA). The aim of this~     trial is to investigate efficacy and safety of Continuous Subcutaneous Insulin Infusion of~     Faster-acting Insulin Aspart compared to NovoRapid® in Adults with Type 1 Diabetes.~   "
56669|NCT02825238|"~     The purpose of this research is to develop and test the feasibility of an exercise~     intervention for persons with painful knee osteoarthritis involving the patella (kneecap).~     Participants in the patellofemoral osteoarthritis (PFOA) group will be treated with a 6-week~     supervised exercise program that targets strengthening the hip and trunk core muscles.~     Painfree control participants will attend one session to gather biomechanical, strength, and~     function data for use in comparison to the patellofemoral osteoarthritis group. Feasibility~     outcomes include adherence to the treatment program, recruitment, and retention. It is~     hypothesized that PFOA group participants will change score on a knee pain and function~     questionnaire by the minimum clinically important difference score for positive improvement~     at the end of the 6-week intervention program.~   "
56670|NCT02825225|"~     The main purpose is to compare the detection rate of 20-core versus 12-core prostate biopsy.~     The secondary objective is to evaluate pain perception using a validated scale to compare the~     analgesia provided by the two different local anesthesia schemes. Data will be prospectively~     collected from patients who will undergo prostate biopsy in a single high volume urology~     center. The patients will be randomized to two different biopsy samplings and two local~     anesthesia schemes.~   "
56671|NCT02825212|"~     10 patients with chronic genotype 1 HCV infection and mixed cryoglobulinemia will be treated~     with Ledipasvir/Sofosbuvir 90mg/400 mg FDC once daily for 12 weeks (naïve subjects or~     non-cirrhotic treatment experienced subjects) or 24 weeks (treatment experienced subjects~     with cirrhosis).~      The researchers anticipate that approximately 20% of subjects may have cirrhosis.~   "
56691|NCT02824952|"~     Patients will receive AZD9291 at a dose of 80 mg once daily. Systemic evaluation will be done~     by PET-CT scan after 6 weeks.~      In responding patients AZD9291 will be given orally 80 mg daily for 12 weeks. Non-responding~     patients will receive AZD9291 for the period of 6 or 12 weeks (according to the results of~     response assessment at each time-point).~   "
56672|NCT02825199|"~     Objective: Assess the effect of caffeine in the following vestibular function tests: Cervical~     Vestibular Evoked Potential (cVEMP), Ocular Vestibular Evoked Potential(oVEMP) and Caloric~     Test.~      Methods: Randomized, prospective triple-blind, placebo controlled clinical trial. All~     participants underwent otoscopy, tympanometry, responded to the Profile of Mood State (POMS),~     submitted to the cVEMP, oVEMP and caloric tests. After that they received placebo or caffeine~     capsule (300mg) and repeated the procedures 45 minutes after.~   "
56673|NCT02825186|"~     The purpose of this study is to compare the efficacy and side effects of topical Loteprendol~     etabonate 0.5% (Lotemax) versus Dexamethasone 0.1% (Sterodex) following strabismus surgery.~   "
56674|NCT02825173|"~     The purpose of this study is to farther assess the safety of the Seal-G Surgical Sealant for~     the reinforcement and protection of gastrointestinal anastomosis.~   "
56675|NCT02825160|"~     This study is collecting post-marketing information on the safety and effectiveness of~     Ventavis under the routine clinical practice for patients with PAH~   "
56676|NCT02825147|"~     Extranodal NK/T cell lymphoma is an aggressive tumor with higher incidence in~     Asia.Traditional CHOP/CHOP-like regiment can't produce satisfied outcome for the patients.~     Asparaginase-based treatment has been demonstrated as promising response rate and survival~     superiority. Stage-specified regimen may bring out exciting efficacy with good safety.~   "
56677|NCT02825134|"~     A randomized clinical trial investigating transcatheter (TAVR) versus surgical (SAVR) aortic~     valve replacement in patients 75 years of age or younger suffering from severe aortic valve~     stenosis.~      Study hypothesis: The clinical outcome (composite endpoint of all-cause mortality, MI and~     stroke) obtained within 1 year after TAVR is non-inferior to SAVR.~   "
56678|NCT02825121|"~     Current guidelines recommend monitoring of neuromuscular blockade at the adductor pollicis by~     stimulation of the ulnar nerve at the wrist.~      However, in certain situations (laparoscopic surgery, cranial surgery or surgical comfort,~     arterial catheterization), it is impossible to access the patient's wrists, delaying~     monitoring, antagonizing the neuromuscular block, the emergence from anesthesia and patient~     extubation , leading in some cases to single injections lack of control of the reversal of~     the patient.~      To overcome these technical difficulties, a group nerve / muscle looks interesting and often~     easily accessible to the anesthesiologist.~      The stimulation of the posterior tibial nerve can observe a response to the flexor hallucis~     brevis muscle and allows quick access to monitoring the reversal before the end of the~     intervention.~      The primary outcome was to compare the speed of recovery from neuromuscular block flexor~     hallux versus that of the adductor pollicis.~      The secondary objective was to compare the speed of installation of deep neuromuscular block~     flexor hallucis versus that of the adductor pollicis.~      This is a prospective, exploratory, uncontrolled, single-center for routine care.~      Are included all aged patients over 18 years, ASA I or II, without guardianship, having no~     known allergy to Atracurium, without neuromyopathy known, emergency surgery or full stomach,~     predictable difficult intubation .~   "
56679|NCT02825108|"~     The present study is designed as a pilot study with 50 patients in each group. Data~     collection form will be filled by the researcher who does not know the type of intervention~     in each group~   "
56680|NCT02825095|"~     Prospective study of the effect of Talc Pleurodesis vs. Indwelling Pleural catheter in~     treatment of patients with malignant pleural effusion~   "
56681|NCT02825082|"~     EMERGENCY GENERAL SURGERY IN GERIATRIC PATIENTS: EPIDEMIOLOGY, AND EVALUATION OF FACTORS~     AFFECTING MORBIDITY AND MORTALITY~   "
56682|NCT02825069|"~     This general population based, randomized controled trial aims at answering two major~     hypotheses: First, systematic early introduction of solid foods decreases the incidence of~     food allergy and dietary restrictions by the age of one year. Second, stimulation with the~     symptom-eliciting food rather than avoidance will induce tolerance in babies with non-severe~     allergic symptoms.~   "
56683|NCT02825056|"~     There is paucity of literature on the effects of intrathecal morphine on the postoperative~     hemodynamics in the cardiac-surgical patients.We planned this study to compare the~     post-operative hemodynamic effects (particularly the incidence of vasoplegia in the two study~     groups) and outcome of combined general anesthesia + high spinal block, with or without~     intrathecal morphine in patients undergoing cardiac-surgical procedures in our set up.~   "
56684|NCT02825043|"~     The primary objective of this study is to look for a correlation between the use of HFNC in~     the outpatient setting in patients with previous COPD exacerbation and the change in their~     BCSS score. The hypothesis is that home use of HFNC will lead to a reduction in BCSS score by~     1.3.~   "
56685|NCT02825030|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
56686|NCT02825017|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
56687|NCT02825004|"~     The purpose of this study is to prevent burnout and offer the hospital staff a space for~     processing the emotional experiences.~   "
56688|NCT02824991|"~     Background: One treatment of Muscle trigger points (MTrPs) is deep dry needling (DN) with the~     purpose of obtaining local twitch responses (LTRs), which are highly effective in releasing~     MTrPs. In DN procedures the mechanisms associated with LTRs and the LTR intensities required~     for optimal clinical results are poorly understood, especially in relation to range of motion~     after intervention. Therefore, evaluating the intensity of LTRs is relevant for implementing~     DN in different clinical settings, such as in patients with muscular or neurological~     dysfunctions. One way to assess muscle contractions and LTRs is through ultrasound video~     analysis.~      The aim of this report was to evaluate the reliability of semi-automatic LTR intensities~     tracking during dry needling by assessing ultrasound signals with an image processing method,~     in addition to evaluating the relationship between LTR intensities and muscle elasticity.~      Method: Young males without signs or symptoms of musculoskeletal pain were included. Primary~     outcome measure was the LTR intensities determined by percentage change of muscle thickness.~     The secondary outcome measures were the muscle elasticity of medial gastrocnemius and~     hamstring, previous and posterior DN in both lower limbs for each subject. Three LTRs,~     detected by a physical therapist and ultrasound assessment, were induced by inserting a~     filament needle into muscle latent trigger points in medial gastrocnemius. The intensities of~     LTRs were measured by assessing ultrasound images using an optical flow method and through~     comparisons with manual detection.~   "
56689|NCT02824978|"~     to evalute if therapeutic alliance is related to adherence in JIA~   "
56692|NCT02824939|"~     This is a randomised controlled trial which will compare the Quadratus Lumborum (QL) Block~     with the Transversus Abdominis Plane (TAP) Block in terms of analgesic efficacy, ease of~     performance and safety when administered postoperatively in patients who undergo laparoscopic~     nephrectomy.~      To fulfill this purpose, three groups of patients each with 32 patients, will be formed.~     Patients in the Transversus Abdominis Plane (TAP) group and Quadratus Lumborum (QL) group~     will each receive the respective blocks with 0.4 ml/kg of 0.25% Bupivacaine, after completion~     of surgery. The third (Control group) will not receive any blocks. After shifting patients to~     recovery all three groups will be put into intravenous patient controlled analgesia (PCA)~     Morphine as rescue analgesic regimen as per a set protocol. Morphine consumption over the~     first postoperative 24 hours, ease of performance of individual blocks and associated adverse~     events, adverse events associated with opioid use, patient recovery and satisfaction will be~     noted.~   "
56693|NCT02824926|"~     This is a non-inferiority, Phase II, open-label, randomized, parallel trial to evaluate~     efficacy and safety of the new intervention (Dapaconazole cream 2%) versus the active control~     (Ketoconazole cream 2%) in patients with Tinea Pedis. Study schedule comprises enrollment,~     treatment and follow-up visits. Treatment period is 14 days.~   "
56694|NCT02824913|"~     The purpose of this Phase 2a study is to assess changes in tear volume by the non-invasive~     techniques Ultra High Resolution Optical Coherence Tomography (UHR-OCT) following the~     administration of P-321 Ophthalmic Solution or Placebo in subjects with tear deficient dry~     eye disease.~   "
56695|NCT02824900|"~     The purpose of this study is to investigate the effects of vibration stimuli to contra~     lateral neck muscles on Contraversive Pusher Syndrome, function and neglect in stroke~     patients.~   "
56696|NCT02824887|"~     Compare the curative effects of electroacupuncture deep needling difference in efficacy of~     the conservative treatment for lumbar five point therapy and routine western medicine, to~     explore the efficacy and superiority, open a new way for the treatment of lumbar disc~     herniation.Through a comparative analysis of the data on the efficacy of different TCM~     Syndrome Types in the subgroup of patients with, to explore the effect of Electroacupuncture~     of deep needling and five lumbar acupoint therapy is most suitable for the TCM syndrome~     type.Through follow-up, patients in the two groups moment condition and the survival of the~     state was evaluated, explore the effect of electroacupuncture deep needling the long-term~     effects of five lumbar acupoint therapy for treatment of lumbar disc herniation and factors~     that may influence the recurrence of symptoms.~   "
56697|NCT02824874|"~     The purpose of this study is to evaluate a pharmacokinetic drug interaction between~     lobeglitazone and sitagliptin in healthy male volunteers.~   "
56698|NCT02824861|"~     This study evaluates a technology based intervention (physical activity tracker, text~     messages, health coach, global positioning system enabled location based feedback on physical~     activity) to support physical activity in cancer survivors after completing oncology~     rehabilitation. In Phase 1 all participants received the full intervention. In phase II~     participants are randomly assigned to receive the full intervention or a fitbit only.~   "
56699|NCT02824848|"~     Congenital muscular torticollis (CMT) results from tightness of neck musculature that causes~     the infant to tilt the head to one side and turn it to the other side. Infants with CMT also~     show unequal use of both sides of the body for movement and play. In this randomized clinical~     trial, researchers will compare two physical therapy (PT) treatment methods, passive~     stretching and Perception-Action (P-A) Approach, in their effects on head position and use of~     both sides of the body in infants with CMT. Behavior demonstrated during PT sessions by~     infants in the two groups will be also compared. Thirty-six infants with CMT will be randomly~     assigned to a passive stretching group or a P-A Approach group. The infants in both groups~     will attend 5 weekly PT sessions, including the initial evaluation, 3 subsequent weekly~     sessions, and a re-evaluation session. At visits 1 and 5, each infant's habitual head~     position, the ability to turn the head to both sides, muscle strength on both sides of the~     neck, motor development, and use of both sides of the body for movement and play will be~     assessed. Each infant's behavior exhibited during therapy will be assessed at visits 2-4.~     Results obtained from the two groups will be compared.~      It is hypothesized that:~        1. There will be significant gains achieved by both intervention groups between the initial~          and final assessments on the following outcome measures:~             1. Still photography~             2. Arthrodial goniometry used to assess active head rotation to both sides~             3. The Muscle Function Scale (MFS) used to assess neck muscle strength~             4. The Alberta Infant Motor Scale (AIMS) used to assess motor development~        2. There will be no significant difference between the groups on the above listed measures~          after the intervention is completed.~        3. The P-A Approach group will achieve greater gains than the passive stretching group~          between the initial and final assessments on the Functional Symmetry Observation Scale~          (FSOS) used to assess the use of both sides of the body for movement and play~        4. The P-A Approach group will demonstrate higher Therapy Behavior Scale (TBS) scores than~          the passive stretching group assigned based on participants' behavior demonstrated~          during PT intervention sessions~   "
56700|NCT02824835|"~     The purpose of this study is to determine the effects of the plant hormones strigolactones,~     on cell cultures of colonic polyps and colorectal cancer.~   "
56701|NCT02824822|"~     Epilepsy is a common condition which affects over 3 million people in the US. Patients with~     uncontrolled epilepsy have a lifetime risk of sudden unexpected death (SUDEP) of 35%, which~     is greatest in those under 40 years of age. The exact mechanisms and causes are not~     understood but can be due to underlying conditions which affect the heart and brain, which~     may lead to dangerous heart rhythms and death. Some of these conditions which affect heart~     and brain have an identifiable genetic cause. This study aims to identify known genetic~     causes of heart rhythm and sudden death related disorders in patients with epilepsy.~   "
56702|NCT02824809|"~     The Aims of the study are estimate the association between the severity of COPD and free~     testosterone level and the prevalence of hypogonadism in adult men with stable COPD~   "
56703|NCT02824796|"~     The purpose of this study is to determine whether a new parent training protocol for children~     with Attention Deficit Hyperactivity Disorder (ADHD) can over perform the state of the art~     Parent Training protocol (PBT) by increasing the long term effectiveness of the treatment,~     reducing the dropout rate and reducing the comorbidities.~   "
56704|NCT02824783|"~     The aim of the study is to investigate the quality of life and satisfaction of patient who~     underwent colorectal surgery using an enhanced recovery protocol when back home.~      In this retrospective study patients will be telephoned and asked to answer a questionnaire.~   "
56714|NCT02824653|"~     Graft versus host disease is a serious and often life-threatening complication in allogeneic~     haematopoietic stem cell transplantation. Although corticosteroids are the first-choice of~     treatment in these patients, but about 30-50% patients do not respond to it and develop~     steroid-refractory GVHD. Mesenchymal stem cells (MSC) have emerged as a promising treatment~     option in these patients. This phase-I/II clinical trial aims at establishing the safety and~     clinical efficacy of allogenic ex-vivo cultured MSCs to treat steroid-refractory GVHD in a~     Pakistani HSCT cohort.~   "
67377|NCT02685033|"~     This clinical study will be a single-center, randomized, open-label, active-controlled,~     parallel-group study comparing dalbavancin to standard of care (SOC) therapy in~     osteomyelitis.~   "
56705|NCT02824770|"~     Endogenous melatonin is produced by the pineal gland at night under normal conditions and~     regulates the sleep-wake cycle. Artificial light administered at night suppresses melatonin~     production and sleep disturbances are accompanied by abnormal melatonin secretion such as~     phase delay. Therefore, dramatic disturbances of endogenous rhythms in intensive care unit~     patients have remarkable effects on melatonin production. In addition to its physiological~     roles in regulating sleep patterns, melatonin has been demonstrated to provide~     antiinflammatory effects in experimental models. Although some previous studies have~     investigated the circadian pattern of melatonin in intensive care unit patients, the~     investigators think that the present study is the first one that will assess the effects of~     controlling noise and light on melatonin and inflammatory response after major abdominal~     surgery.~   "
56706|NCT02824757|"~     This study is aimed at exploring the effects of glucocorticoids on glucose metabolism in~     patients with interstitial lung disease. Patients with interstitial lung disease who is on~     the medication of 15mg prednisolone and 7.5mg prednisolone conduct the continuous glucose~     monitoring (CGM). The data attained from the CGM are used to define the glycemic~     characteristics in patients using glucocorticoids and the difference of glucose features due~     to different doses.~   "
56707|NCT02824744|"~     The purpose of the study is to evaluate prospectively the clinical benefits of 2 different~     flow with High flow nasal canula (HFNC: 2l/kg/min) versus (HFNC: 2l/kg/min) in the initial~     management of bronchiolitis in infants.~      Design: Prospective, controlled, randomized, multi-center.~      Design: Infants less than 6 month admitted in pediatric intensive care unit for respiratory~     distress (mWCAS >3) secondary to bronchiolitis but not requiring mechanical ventilation will~     be randomized in two groups:HFNC 2l/min/kg or HFNC 3l/min/kg during 24 hours.~      Conditions of measurements:~      Primary endpoint: Proportion of failure in both arms during the first 24 hours.~      Failure criteria: A raise of the Clinical score for respiratory distress (mWCAS) (1 point) or~     respiratory rate (10/min /H0 and above 60/min) or discomfort (EDIN) (1point /H0 and above 4)~     or apnea.~      Secondary outcomes: Assessment at H1, H12, H24 of mWCAS, respiratory and heart rate, EDIN~     score, skin lesions, FiO2 required to achieve an oxygen saturation between 94 and 97%,~     transcutaneous PCO2 (correlated to an initial gas analysis), Report SpO2 / FiO2~      Statistic: Intention to treat Analysis.~      Expected number of patients: 135 per arm: 270 children.~   "
56708|NCT02824731|"~     This protocol compares the toxicity of radiotherapy or radiochemotherapy applied with~     different radiation modalities - protons or photons. Patients with different kinds of brain~     tumours and foreseen high-dose radiotherapy can be included. The hypothesis of the trial is~     that the rate of chronic toxicity 1 year after the end of radiotherapy is 15% lower after~     proton compared to photon treatment.~   "
56709|NCT02824718|"~     Hypoparathyroidism is a rare condition in which the parathyroid glands fail to produce~     sufficient amount of parathyroid hormone or the parathyroid hormone produced lacks biologic~     activity. The most common cause of hypoparathyroidism is damage to or removal of the~     parathyroid glands due to neck surgery for another condition. Occurrence of hypercalciuria~     under treatment is a frequent concern in primary hypoparathyroidism, limiting correction of~     hypocalcemia.~      Hypoparathyroidism can also be caused by an autoimmune process. In rare cases,~     hypoparathyroidism may occur as a genetic disorder inherited as an autosomal recessive,~     autosomal dominant or X-linked recessive trait. The autosomal dominant hypocalcemia (ADH) is~     mainly caused by heterozygous activating mutations in the CASR gene encoding CaSR). As other~     severe presentation of primary hypothyroidism, ADH is characterized by the increased risk to~     develop hypercalciuria and nephrolithiasis. The purpose of the study is to compare two~     therapeutic approaches in severe hypoparathyroidism in order to limit the risk of~     nephrocalcinosis and renal failure when attempting to correct hypocalcemia: rhPTH(1-34) vs~     association of active vitamin D and hydrochlorothiazide. The European Society of~     Endocrinology Clinical has indeed recently published guidelines for the treatment of chronic~     hypoparathyroidism in adults. These guidelines suggest considering treatment with a thiazide~     diuretic In a patient with hypercalciuria and replacement therapy with PTH in patients who do~     not stably and safely maintain their serum and urinary calcium in the target range.~   "
56710|NCT02824705|"~     Approximately 40,000 infants are born each year in the United States with congenital heart~     defects (CHD), and heart defects are the leading cause of birth defect-related deaths in the~     United States. While advances in surgical treatment, cardiac bypass, and post-operative~     management have improved mortality for children born with heart defects, these children~     continue to have significant morbidity related to post-operative malnutrition, multiple organ~     dysfunction (MODS), and sepsis. Proposed mechanisms for post-operative sepsis and MODS is via~     loss of intestinal epithelial barrier function (EBF) or intestinal micro biome diversity.~      The purpose of this multi-center observational cohort study is to understand the extent to~     which practice variation for routine post-operative care might worsen intestinal barrier~     dysfunction and reduce diversity of the intestinal microbiome for infants undergoing surgical~     correction of left sided cardiac obstructive defects. We will enroll 80 children with left~     sided obstructive congenital cardiac lesions across several US congenital cardiac centers to~     obtain clinical data and biological specimens. We will leverage existing differences in~     nutritional and antibiotic strategies at these centers to better understand how intestinal~     barrier function and the intestinal microbiome may contribute to post-operative multiple~     organ dysfunction syndrome.~   "
56711|NCT02824692|"~     The purpose of this study is to determine whether a focused ultrasound examination for the~     heart, lungs and abdomen, preformed by a trained anesthesiologist, can reveal significant~     clinical findings in elderly patients before emergent surgery.~   "
56712|NCT02824679|"~     A case control study conducted on 120 women coming to Cairo University Maternity Hospital~     .Patients who meet the inclusion criteria were asked to participate in the study and a verbal~     consent was obtained from each patient. Patients will be divided into three equal groups (A,~     B, C). A single dose of the drug (placebo or HBB 20mg or HBB 40 mg) will be injected~     intravenously slowly to groups A, B, C respectively. Labouring mothers will be monitored in~     bed. Vaginal examination will be conducted every two hours. The duration of the first stage~     was calculated from the time of cervical dilatation of three to four centimeters in active~     labour until a fully dilated cervix will be observed~   "
56713|NCT02824666|"~     This study involves evaluating the occupancy of ATI-9242 at steady state at three different~     dose levels on D2 receptors in the brain using [18F] Fallypride PET in up to three cohorts of~     subjects.~   "
56715|NCT02824640|"~     People who inject drugs (PWID) have higher rates of hepatitis C virus (HCV) than do other~     groups. Effective, safe new treatments called direct-acting antiviral agents (DAAs) have been~     developed recently. Unfortunately, PWID rarely get these treatments. The drugs are expensive,~     so insurers often do not cover the cost of DAAs. Sometimes providers hesitate to prescribe~     DAAs because they are concerned that PWID won't take their medication or that these patients~     might become reinfected.~      Several good models for treating PWID exist. One of them is to provide directly observed~     treatment (DOT). Another model provides treatment to PWID with the support of patient~     navigators (PN), public health workers who offer support and education to patients. Though~     both the DOT and PN models have been successful, we still don't know which model works best.~      In this study, the investigators will study both DOT and PN models for treating HCV in PWID.~     The investigators' goal is to find out which model produces the best results and is preferred~     by patients. Up to 1,000 HCV-infected PWID will participate in the study in eight sites~     around the country. Patients will be randomized into either the PN or the DOT groups.~     Patients who end up in the PN group will get a biweekly blister pack of medication to take~     home. Their PN will provide education and support. The investigators will find out whether~     patients adhered to medication using an electronic adherence monitoring system. Patients who~     are randomly assigned to the DOT group will take their medication in front of a staff member.~   "
56716|NCT02824627|"~     Irritability and emotional dysregulation are recognized as serious aspects of psychopathology~     seen in in pediatric psychiatric patients. While various behavioral as well as~     psychopharmacological interventions have shown some efficacy in improving irritability and~     emotional dysregulation, there are no data determining the neurobiological mechanism of~     effect at the neural level. Previous studies have demonstrated that heightened amygdala~     response to negative emotional stimuli is closely related to irritability and emotional~     dysregulation in children and adolescents. Also, there are studies showing administration of~     oxytocin can decrease the heightened amygdala response to negative emotional stimuli across~     various psychiatric diagnoses. This study is a double-blind randomized trial of oxytocin for~     irritability and emotional dysregulation in the pediatric population. Neuroimaging modalities~     of fMRI and MEG are employed to probe the neuro-circuitry changes occurring as a result of~     the oxytocin intervention, specifically including heightened amygdala response to negative~     emotional stimuli and dysfunctional fronto-amygdala connectivity. The investigators will also~     investigate the genetic sequence of the oxytocin receptor in the study participants and its~     relationship with symptom profile and neural activity changes. Children and adolescents (age~     10-18) with a diagnosis of disruptive mood and/or behavior disorders (including Attention~     Deficit/Hyperactivity Disorder [ADHD], Oppositional Defiant Disorder [ODD], Conduct Disorder~     [CD], and Disruptive Mood Dysregulation Disorder [DMDD]), and clinically significant levels~     of irritability and emotional dysregulation as measured by the Affective Reactivity Index~     Scale (score>/= 4).~      2 weeks randomized, double-blind treatment with intranasal oxytocin (24 IU daily, or 12 IU~     daily if the weight is < 40kg) with assessment of diagnosis, symptom profiles (the Affective~     Reactivity Index [ARI], Inventory of Callous-Unemotional Trait [ICU], Behavior Assessment~     System for Children, second version [BASC-2], and Clinical Global Impression [CGI]) and pre-~     and post-oxytocin treatment neuroimaging (fMRI and MEG). The genetic sample will be obtained~     via buccal mucosa sampling.~      Participants may receive outpatient clinically indicated follow-up care in the UNMC~     department of psychiatry or other local community agency as appropriate.~   "
56717|NCT02824614|"~     Sugar alcohols such as xylitol and erythritol are increasingly popular as sugar substitutes~     in the food industry and are also recommended to diabetic patients. Both substances are~     already in use in the food industry and are freely available. Since the 1970s, beneficial~     effects on oral health could be demonstrated as oral bacteria were influenced positively.~     Animal studies showed an increase in gut Clostridium perfringens after xylitol intake;~     certainly a non-desirable effect. However, studies on effects of erythritol and xylitol on~     the human gut microbiota are lacking so far. In this trial, investigators aim to examine~     whether gut microbiota and glucose tolerance can be influenced by polyol intake in a~     non-diabetic but obese cohort.~   "
56718|NCT02824601|"~     This randomized clinical trial evaluated the effectiveness of supplemental photodynamic~     therapy (PDT) in optimizing the removal of bacteria and endotoxins from primarily infected~     root canals after one-visit and two-visit treatments.Twenty-four primarily infected root~     canals with apical periodontitis were selected and randomly divided into one-visit (n=12) and~     two-visit treatments (n=12). Chemo-mechanical preparation (CMP) was performed by using the~     single-file reciprocating technique + 2.5% NaOCL and a final rinse with 17% Ethylenediamine~     tetraacetic acid (EDTA). The photosensitizer agent (methylene blue 10 mg/mL) was applied to~     root canals for 60 seconds and submitted to laser with a potency of 60 milliwatts (mW) and~     energy density of 129 J/cm2 for 120 seconds after CMP in the one-visit treatment and after~     14-day inter-appointment medication with Ca(OH)2 + saline solution (SSL) in the two-visit~     treatment. Samples were collected before and after root canal procedures. Endotoxins were~     quantified by chromogenic limulus amebocyte lysate assay. Culture techniques were used to~     determine bacterial colony-forming unit counts.~   "
56719|NCT02824588|"~     The goal of this project is to investigate and improve executive control function in two~     distinct pain conditions, namely neuropathic pain and fibromyalgia (FM). It is hypothesized~     that there is a significant difference in the executive control function of patients with~     neuropathic pain and FM pain. It is also hypothesized that all participants with poor~     executive control functioning will report significant improvements in pain intensity,~     functioning and cognitive complaints following cognitive training. The study tests and~     influence the working memory concepts of inhibition, updating and flexibility through an~     experimental, cross-over treatment design.~      To perform the experiment, we will recruit 160 participants (80 with neuropathic pain and 80~     with FM) from the Departments of pain management and research at St Olav's University~     Hospital and Oslo University Hospital (OUS). The proposed design will be able to determine~     whether or not executive control, processing speed and memory function differs in two~     distinct populations of pain patients. Moreover, whether impairments are amended by~     computerized training.~   "
56720|NCT02824575|"~     The purpose of this study is to determine the safety and tolerability of rebastinib when~     combined with antitubulin therapy with paclitaxel or eribulin in patients with advanced~     breast cancer.~   "
56721|NCT02824562|"~     Due to its specific pathophysiology and impact on health outcomes, the Institute of Medicine~     has described chronic pain as a complex chronic disease and a national public health~     crisis. The unique neurobiological basis and psychosocial context of chronic pain in~     HIV-infected patients underscores the importance of developing and testing a behavioral~     intervention specifically tailored to this population. This study will pilot test a~     newly-developed behavioral intervention for chronic pain tailored to individuals with HIV.~   "
56722|NCT02824549|"~     The usability, skin reactions and accuracy of the FreeStyle Libre glucose monitoring system~     in children will be evaluated by questionnaires, pictures of the insertion site and~     comparison of the glucose results with capillary blood glucose determinations.~   "
96043|NCT02310022|"~     Comparative bioavailability and pharmacodynamics effects of MAT9001 versus an active omega-3~     medication comparator.~   "
56723|NCT02824536|"~     This is a phase 1 clinical trial to evaluate the safety and pharmacokinetics of the highly~     neutralizing anti-human immunodeficiency virus-1 monoclonal antibodies 3BNC117 and 10-1074,~     when given in combination, in human immunodeficiency virus (HIV)-uninfected individuals. This~     study is intended to support the development of the combination of 3BNC117 and 10-1074 mAbs~     for use as prophylaxis against HIV infection in healthy HIV-uninfected individuals at risk~     for HIV infection.~   "
56724|NCT02824523|"~     The purpose of this research study is to learn new information about the underlying cause of~     aspirin-exacerbated respiratory disease (AERD) and the benefit of high-dose aspirin therapy.~     AERD is a disease that involves asthma, recurring nasal polyps, and respiratory reactions to~     aspirin and other nonsteroidal anti-inflammatory drugs. This study will be conducted on~     individuals with AERD who are referred to the Brigham and Women's Hospital AERD Center for~     clinical evaluation and potential aspirin desensitization. Desensitization to aspirin and~     subsequent treatment with daily high-dose oral aspirin is standard of care for patients with~     AERD who do not respond adequately to steroids and have recurrent nasal polyposis or~     symptomatic asthma. This study will involve four visits to Brigham and Women's Hospital and~     will align closely with the standard of care for the treatment of AERD.~   "
56725|NCT02824510|"~     The objectives of the study are: 1) to evaluate the effects of moderate exercise on SG~     evolution without insulin dose modification in patients with T1D under continuous~     subcutaneous insulin infusion (CSII) and multiple daily injection (MDI) therapy, and compare~     differences between these 2 groups; 2) to evaluate the impact of insulin dose modification~     (bolus, basal, reduction or increase, based on SG evolution profile obtained after first~     exercise) before and/or during moderate exercise on T1D children under CSII and MDI regimen,~     and compare differences between these 2 groups.~   "
56726|NCT02824497|"~     Respiratory distress is one of the first hospital grounds during the neonatal period. The~     clinical presentation and severity vary by gestational age and cause. She reports to various~     etiological factors as maternal, neonatal or sometimes entangled. The symptomatic management~     has benefited from organizational progress (perinatal care) and techniques, including~     antenatal steroids, the use of exogenous surfactant and non-invasive ventilation early, so~     that the use of intubation is less frequent. The short-term evolution of patients with early~     respiratory distress is based on gestational age, cause and initial management.~   "
56727|NCT02824484|"~     This study aims to investigate the efficacy of Guided Written Disclosure Protocol (GWDP) in~     promoting post-traumatic growth through a process of meaning reconstruction in cancer~     patients at the end of chemotherapy. Also, the intervention (GWDP) intends to reduce distress~     symptoms (i.e. intrusive thoughts, avoidance, depression and anxiety).~   "
56728|NCT02824471|"~     'Sickle-shaped' anemia was first clinically described in the US in 1910, and the mutated~     heritable sickle hemoglobin molecule was identified in 1949. The pathophysiology of SCD is a~     consequence of abnormal polymerization of sickle hemoglobin (HbS) and its effects on red cell~     membrane properties, shape, and density, and subsequent critical changes in inflammatory cell~     and endothelial cell function. Our goal is to understand the impact of CMA abnormalities in~     SCD, by interrogating a number of recognized interactions in a range of clinical phenotypes.~      To date, correlative studies in SCD, by us and others, have range between clinical reports,~     based on tests, interventions, and chart review of individuals or groups of individuals and,~     at the other extreme, identification of functional gene polymorphisms based on population~     studies. The investigators wish to augment these studies through a systematic examination of~     cellular membrane properties and activation status. Of hematologic disorders, SCD may be~     unusually susceptible to such an examination.~   "
56729|NCT02824458|"~     The main purpose of this study is to evaluate the safety and efficacy of Apatinib in~     combination with Gefitinib as compared to placebo in combination with Gefitinib in~     participants with stage ⅢB-IV Non-squamous non-small-cell lung cancer (NSCLC) harboring an~     activating epidermal growth factor receptor (EGFR) mutation (Del19 and L858R). Safety and~     tolerability of Apatinib in combination with Gefitinib will be assessed in the first portion~     (Part A) before proceeding to the second portion of this study (Part B).~   "
56730|NCT02824445|"~     After 13 years of war, PTSD has become pervasive in service members. Traditionally it is~     evaluated by PTSD Checklist Military Version (PCL-M) and treated with cognitive processing~     therapy, prolonged exposure therapy and medication management with limited success.~     Repetitive Transcranial Magnetic Stimulation (TMS) has shown efficacy for improving~     individual cognitive function in the past decades, both in healthy population and in patients~     with depression. TMS has been approved by the FDA in treatment of major depressive disorder~     and migraine headaches. Magnetic EEG guided Resonant Treatment (MeRT) is a form of~     individualized TMS based on member's EEG/ECG input. Investigators propose to use MeRT to~     treat veterans with war-related PTSD, a syndrome that includes depressive and anxious~     symptoms; it is likely that MeRT (namely TMS) will be beneficial and comparable to or better~     than the current FDA approved methods for treating PTSD.~   "
56731|NCT02824432|"~     The purpose of this study is to explore the effects of omega-3-acid ethyl esters (TAK-085) on~     vascular endothelial function when administered for 8 weeks, as measured by FMD, in patients~     with hyperlipidemia.~   "
56732|NCT02824419|"~     The goal of the current study is to evaluate the potential of the selected PET tracers to~     detect sarcoidotic lesions in lungs. The tracers are already in clinical use for the~     detection of certain inflammatory processes or malignant tumors, and their targets present~     similarities with molecular mechanisms of sarcoidosis.~   "
56733|NCT02824406|"~     The primary aim of this study is to evaluate MRI-based cerebrovascular reserve (CVR)~     measurements in adult patients with Sickle Cell Disease (SCD).~      The primary objective is to assess whether there is a correlation between CVR and silent~     cerebral infarcts (SCIs).~   "
56734|NCT02824393|"~     The aim of this study is to determine whether autologous adipose tissue derived Mesenchymal~     Stem Cells of treatment for chronic autoimmune urticaria is safe and effective.~   "
56735|NCT02824380|"~     An Open-label, Randomized, Multiple-dose, Crossover Study to Evaluate the Pharmacokinetics/~     Pharmacodynamics and Safety of DA-4001 in Healthy Male Subjects with Androgenic Alopecia.~   "
56900|NCT02822235|"~     The purpose of this study is to gather information regarding the population with moderate to~     severe inflammatory bowel disease (IBD), the burden of the disease, and understand their~     treatment patterns, particularly on the use of available biologic therapies.~   "
56736|NCT02824367|"~     Scientific studies show that almost half of the people with Parkinson's Disease (PD) suffer~     of depression and / or anxiety. Also, clinicians reported that they exhibit specific~     personality traits (e.g., rigidity and perfectionism).~      To date, few studies used Cognitive Behavioural Therapies (CBT) in people with Parkinson's~     disease showing promising results. Recently, perfectionism has received particular attention~     because of it association with many emotional disorders. Thus, some psychometric tools have~     been developed in order to evaluate different aspects of perfectionism. Yet, none of them has~     been used in people with Parkinson's disease.~      The objective of this study is to investigate whether there is a direct link between~     Parkinson's disease and perfectionism by using psychometric tools from the CBT literature.~     Identifying such link would allow to justify the use of CBT in people with Parkinson's~     disease with the goal in mind to improve their care and quality of life.~   "
56737|NCT02824354|"~     Nalmefene is the first drug to obtain Marketing Authorisation in France for reduction of~     alcohol consumption. It appears to be significantly more effective in the group of heavy~     drinkers, while the mean alcohol consumption in studies conducted in cirrhotic patients is~     greater than 120 g/day.~      No data are available concerning nalmefene in alcohol-dependent patients with alcoholic~     cirrhosis. However, nalmefene could represent an attractive alternative to reduce heavy~     drinking in patients with alcoholic cirrhosis, with potential improvement of liver function.~     No comparator is available for nalmefene, as all other molecules require abstinence prior to~     starting treatment.~   "
56738|NCT02824341|"~     Up to 60% of Parkinson's Disease (PD) patients suffer from REM sleep behavior disorder (RBD),~     a parasomnia. This disorder is thought to be related to a dysfunction of limbic system and~     brainstem.~      Impulse control disorders (ICD) are found in about 14% of PD patients taking dopaminergic~     drugs. These disorders are thought to be related to a dysfunction of meso-cortico-limbic~     pathways which belong to the so-called reward system.~      A strong link was found between these two disorders and therefore the investigators believe~     that RBD is associated with impaired reward system.~      The main objective of this study is to evaluate differences in brain activation between PD~     patients with and without RBD.~      The investigators hypothesize that PD patients with RBD have a more severe dysfunction of the~     reward system (hypoactivation of the meso-cortico-limbic pathway) than patients without RBD,~     explaining their susceptibility to ICD when exposed to high doses of dopaminergic treatment.~   "
56739|NCT02824328|"~     The investigators propose to collect biologic samples (i.e. tumor tissue, ascites, and/or~     blood), from patients undergoing standard of care therapy for a gynecologic malignancy. To~     detect changes in the immune response following chemotherapy, collection of biologic samples~     will occur at baseline and at the time of surgery following chemotherapy.~   "
56740|NCT02824315|"~     The purpose of this study is to investigate the steady-state pharmacokinetics (PK) of~     simeprevir (SMV), odalasvir (ODV) and AL-335 (and its metabolites ALS-022399 and ALS 022227),~     when these drugs are co-administered in healthy Japanese participants.~   "
56741|NCT02824302|"~     Labor pain is complex to understand and challenging to define because of the interaction of~     multiple maternal and fetal factors. Poorly controlled acute post-procedural pain may result~     in harmful physiological and psychological consequences for both mother and baby. It is~     therefore important to understand the prelabor factors that may affect the labour pain to~     facilitate the intrapartum pain management. The goal of this prospective observational study~     is to verify if expectations regarding pain experience translate to actual pain outcomes for~     women who are undergoing induction of labor.~   "
56742|NCT02824289|"~     A sample of local government organizations are recruited to a group-randomized~     pretest-posttest controlled trial evaluating the effect of a campaign to promote workplace~     policy and education on sun protection for outdoor workers. Primary outcome is adoption of~     formal policies and secondary outcomes are implementation of policy and sun protection~     practices by outdoor workers.~   "
56743|NCT02824276|"~     Chronic low back pain (CLBP) afflicts up to 50 million U.S. adults and is a primary cause of~     disability and reduced quality of life. The prescription of opioids for chronic low back pain~     (CLBP) has increased substantially within the past decade in the U.S. As noted by the CDC in~     their recent Guideline (released in March 2016): Opioids are commonly prescribed for pain.~     An estimated 20% of patients presenting to physician offices with noncancer pain symptoms or~     pain-related diagnoses (including acute and chronic pain) receive an opioid prescription.~     Interestingly, patients scoring very high on measures of psychological distress tend to be~     systematically excluded from RCTs, even though this subgroup of patients is highly prevalent~     within the chronic pain population.~      This study will provide key information on individual differences in the outcomes of opioid~     treatment, and its findings should facilitate more effective tailoring of analgesic regimens~     to individual patient characteristic.~   "
56744|NCT02824263|"~     Obstructive sleep apnea is a risk factor for diabetes and cardiovascular disease, by unknown~     mechanisms. The investigators hypothesize that sleep apnea changes glucose and lipid~     metabolism during sleep, which over time could lead to diabetes and cardiovascular disease.~     This study examines metabolic changes during sleep in patients with obstructive sleep apnea.~     Patients accustomed to CPAP therapy are enrolled to undergo sleep studies, either on CPAP~     therapy or after withdrawing from CPAP for 3 nights. During sleep, blood samples are obtained~     so that metabolic function can be compared between sleep apnea and CPAP nights.~   "
56745|NCT02824250|"~     The primary aim of this study is to conduct a randomized controlled feasibility trial of MBSR~     for patients with moderate-to- severe migraine headache.~   "
56752|NCT02824159|"~     Recently, European Medicines Agency approved ibrutinib and idelalisib to treat Chronic~     Lymphocytic Leukemia (CLL) and two lymphomas: Follicular Lymphoma (FL) for ibrutinib and~     Mantle cell lymphoma (MCL) for idelalisib.~      Clinical trials for ibrutinib and idelalisib were performed with a small number of patients~     (300-350) and showed several side effects profiles. Since, pharmacokinetic properties of~     these 2 drugs highlight a interindividual variability of pharmacokinetic. The aim of this~     study is to determine the association between clinically significant side effects occurrence~     during the first year of treatment and plasma mean concentration of the steady state of~     ibrutinib or idelalisib at 1 month.~   "
56914|NCT02822040|"~     This study will attempt to validate a method of estimating root length on panoramic~     radiograph by crown measurement on intraoral digital scans.~   "
56746|NCT02824237|"~     Background:~      The increasing effect of environmental, occupational and climate change poses serious global~     threat for public health. More than half of the world's population, including around 85%~     people in Bangladesh, are exposed to household air pollutants (HAP). Environmental~     consequences of climate change are among the highest. Little evidence is available on the~     effects HAP on cardiopulmonary outcomes in low-income populations. Same is true for~     occupational health and climate change. The investigators will evaluate the effects of HAP on~     cardio-pulmonary and markers of immune function among non-smoking individuals. The~     investigators will also conduct two pilot studies to explore health effects associated with~     working in the garments industry and that of temperature due to climate changes.~      Hypothesis:~        1. Preclinical measures of cardiovascular diseases and pulmonary function are associated~          with exposure level of house hold air pollution (HAP) (assessed through PM2.5, CO and BC~          concentrations)~        2. Stable biomarkers of immune function and inflammation are associated with exposure level~          of HAP.~        3. Use of improved cook stove reduces exposure to HAP and thereby improve pre-clinical and~          molecular measures of cardio-pulmonary and immune functions.~      Methods: The investigators will conduct a cross sectional study to assess the associations of~     HAP with preclinical makers of CVD among 600 non-smoking participants aged 25 to 65 years.~     Biomass exposure will be assessed for PM2.5, carbon Monoxide (CO) and black carbon (BC) by~     collecting personal air samples for 24-hour. Blood sample will be utilized from a subset of~     200 adult participants and 60 children aged 3-5 years for assessing immune markers. The study~     will be conducted in icddr,b and URB study site at Matlab and Araihazar respectively.~      After the cross sectional assessment, the investigators will conduct a pre-post intervention~     study to evaluate effectiveness of improved stoves in a subset of 200 homes. The~     investigators will measure the aforementioned markers after two years of cook stove~     installation. Finally, as pilot studies, health outcomes due to climate change (temperature~     change) and occupation (garment industry work) will be explored.~      Outcome measures:~      HAP will be assessed through PM2.5, CO and BC concentrations. Pulmonary function will be~     assessed through FEV1, FVC and FEV1/FVC. Preclinical makers of CVD will include RH-PAT, FMD,~     IMT, BAD, EKG and PFT. Markers of Immune function - proliferation of macrophage, dendritic~     cells (DC), neutrophils and T-cell, as well as macrophage derived cytokines (a panel of 17 or~     27 cytokines) in peripheral blood mononuclear cells (PBMC)~   "
56747|NCT02824224|"~     This study evaluates the ability of tamoxifen to improve frequent or prolonged bleeding in~     new users of the 52mg levonorgestrel-releasing intrauterine device. Half of participants will~     receive a course of tamoxifen three weeks after insertion of the IUD, while the other half of~     participants will receive a course of placebo.~   "
56748|NCT02824211|"~     Purpose: To investigate the feasibility of a new oxygen delivery device, the Right Dose~     System (RDS). It delivers individualized boluses of oxygen during rest and exertion to~     maintain acceptable oxygen saturations.~      The procedures include: Enrollment of 10 patients, who are randomized to either exercise with~     their oxygen prescription followed by exercise with the RDS, or exercise with the RDS~     followed by exercise on their oxygen prescription. Randomization will occur on a 1:1 basis.~     Each set of exercise will be separated by a 30 minute recovery session. Subjects will be~     adults who are on supplemental oxygen and are able to exercise on a treadmill. Subjects will~     be above 18 years of age. Subject participation will last approximately 1 month. Subjects~     will be recruited from the Loma Linda pulmonary clinic and the pulmonary rehabilitation~     program. Consent will take place in the pulmonary clinic, pulmonary function lab or pulmonary~     rehabilitation by trained study physicians. If Multi-center: N/A (single center) If Single~     center or investigator-initiated: 10 subjects will participate in the study.~   "
56749|NCT02824198|"~     The aim of the study is to assess and describe the booster effect of a CYD dengue vaccine~     dose administered 5 years after the completion of a 3-dose vaccination schedule.~      Primary Objective:~        -  To demonstrate the non-inferiority in terms of geometric mean of titer ratios (GTMR) of~          a CYD dengue vaccine booster compared to the third CYD dengue vaccine injection in~          subjects from CYD 28 trial (subjects from Group 1 only).~      Secondary Objectives:~        -  If the primary objective of non-inferiority is achieved: To demonstrate the superiority,~          in terms of GMTRs, of a CYD dengue vaccine booster compared to the third CYD dengue~          vaccine injection in subjects from CYD28 trial (subjects from Group 1 only).~        -  To describe the immune responses elicited by the CYD dengue vaccine booster or placebo~          injection in subjects who received three doses of the CYD dengue vaccine in the CYD28~          trial in all subjects.~        -  To describe the neutralizing Abs levels of each dengue serotype post-dose 3 (CYD28~          subjects) and immediately prior to booster or placebo injection in all subjects.~        -  To describe the neutralizing Ab persistence 6 months, 1 year and 2 years post booster or~          placebo injection in all study subjects.~        -  To evaluate the safety of booster vaccination with CYD dengue vaccine in all study~          subjects.~   "
56750|NCT02824185|"~     Hepatocellular carcinoma (HCC) is the fifth most common cancer in terms of incidence and the~     second in terms of mortality. At an early stage, which is based on a low number and size of~     liver nodules and the absence of extra-hepatic locations (Milan criteria), a curative~     treatment can be performed, i.e. liver transplantation, surgical resection, or~     thermo-ablation. These treatments can lead to severe complications, so patients benefiting~     from them must be carefully selected. The correct identification of all HCC lesions at the~     time of the therapeutic decision is crucial. MRI is the reference examination for diagnosis~     but its field of exploration is limited to the upper abdominal area and its sensitivity~     decreases for nodules of less than two centimetres. Such lesions could actually be HCC that~     will cause early post-operative progression.~      Positron Emission Tomography (PET; functional imaging) with fluorodeoxyglucose can provide~     prognostic information but impacts initial staging in less than 5% of cases. However, PET~     with fluorocholine (FCH), available in France since 2010, could detect intra- and~     extra-hepatic HCC lesions not identified by conventional imaging, potentially impacting~     patient management (e.g. 52% of patients in a small case study).~      FCH-PET/MRI could therefore be the ideal examination for the initial staging of HCC,~     combining in a single multimodality investigation the reference morphological imaging~     technique and an efficient functional one. The hypothesis of this study is that FCH-PET/MRI~     is able to detect, in patients eligible for curative treatment, additional preoperative~     intra- and extra-hepatic early or metastatic HCC unseen or equivocal with conventional~     imaging (CT and MRI) and responsible for recurrence or disease progression at 6 months.~   "
56751|NCT02824172|"~     The disease Osgood-Schlatter is most commonly found in sports teenager growing up apophysose~     accounting for 28.4% of osteochondrosis by Breck. It relates to 62% of osteochondrosis knee~     and affects adolescent girls between 10 and 12 and boys between 12 and 15 It is usually~     considered a benign pathology that cures in the majority of cases. However, in 5-10% of cases~     there is persistent residual pain in adulthood.~      The classic complication is the avulsion fracture of the tibial tuberosity in adolescents who~     continued his sports without restriction.~      The possible consequences are numerous including the presence of a free bone fragment at the~     insertion of the tendon originally described by Osgood the establishment of a genu~     recurvatum, a high kneecap or patella alta and an enlarged tibial tuberosity (ATT) annoying~     sport.~      The main two treatments are complete rest from sport activity or cast immobilization.~      The main objective is to compare these two technics according to the proportion of full~     sporting recovering at 12 months~   "
56753|NCT02824146|"~     Anesthesia-induced atelectasis is a well-known entity observed in approximately 68-100% of~     pediatric patients undergoing general anesthesia. The collapse of dependent lung zones starts~     with anesthesia induction but can persist for hours or even days after surgery. Such~     anesthesia-related atelectasis has a number of negative clinical consequences such as the~     impairment of arterial blood oxygenation and lung mechanics as well as the predisposition for~     ventilator-associated lung injury. The adjustment of ventilator settings for preventing the~     occurrence of atelectasis and for reducing pulmonary complications remains controversial.~      Lung sonography (LUS) plays an important role in diagnosing pulmonary diseases in children,~     including atelectasis of different origins. LUS has demonstrated its high sensitivity and~     specificity for diagnosing anesthesia-induced atelectasis in children.~   "
56754|NCT02824133|"~     The investigators will look for the presence of the fusion gene in all patients operated on~     for glioma. This search will be limited to all gliomas that show no IDH1 mutation, the latter~     being sought in both routine and anomalies never co-existing.~      The hypothesis is that the rate of progression-free survival in grade IV gliomas and III~     without IDH1 mutation, with the usual chemotherapy, only 15% at 6 months (ie, 85% of patients~     relapse before 6 months of treatment), must be with this new treatment 35% (primary~     endpoint).~      The main objective is the evaluation of disease-free survival at 6 months.~   "
56755|NCT02824120|"~     Laugh is more than visual and vocal behave, is always followed by a series of physiological~     changes, including contractions of musculoskeletal system, increase of cardiac frequency by~     catecholamine release and hyperventilation that promoves the increase of maximum breathing~     and oxygen saturation. Laugh therapy may be an alternative therapy, simple, and improve the~     quality of life of individuals can influence physiological and biochemical parameters of the~     human body.~   "
56756|NCT02824107|"~     The aim of this study is to identify groups of subjects at risk of recurrence in secondary~     prevention based on Psychosocial Factors.~      The aim is also to propose novel levers to reduce health inequalities in this population so~     as to develop new prevention strategies for neuro- and cardio-vascular health This study is~     based on data from questionnaires (Quality of life at work, perceived stress, perceived~     disease severity) and on behavior indicators (factors related to lifestyle: alcohol, smoking,~     obesity, sedentarity).~      Biomarkers of endothelial function (ADMA) will also be assayed. It's an interventional study~     because of blood sample~   "
56757|NCT02824094|"~     Primary objective of this study is to allow access and evaluate the safety of crizotinib for~     patients in Japan with advanced NSCLC harboring a translocation or inversion involving the~     ROS1 oncogene.~   "
56758|NCT02824081|"~     Suicide is a major health problem that causes annually a million death worlwide. In the~     stress-vulnerability model, suicidal behavior (SB) results from the interaction between an~     individual's predisposition (personality, family history of SB…) and stressful conditions~     (early life adversity).~      Studies show that suicide ideations could favour inflammation and that depression is~     associated with an elevated inflammation.~      Recent evidences also suggest that inflammatory mediators play a critical role in SB.~      The aim of the study is to evaluate the inflammatory markers rate on depressed patients with~     or without personal history of SB.~      In the second part of the study, the relations between the rates of inflammatory markers and~     characteristics of SB, impulsivity, psychological pain, childhood abuse and gene expression~     of 5HT2B receptor will be investigated.~   "
56759|NCT02824068|"~     Long-term outcome in late-onset Pompe disease treated beyond 36 months (ATBIG-Pompe-Study), a~     multicenter, multinational, longitudinal, non-interventional observational study in subjects,~     at least 8 years old, diagnosed with late-onset Pompe disease retrospectively and~     prospectively collects data to understand clinical progression in terms of muscle and~     respiratory function, and clinical symptomology treated with alglucosidase alfa more than 36~     months in 100 subjects.~   "
56760|NCT02824055|"~     This is a multicenter, randomized, double-blind, placebo-controlled, three period crossover~     study to evaluate the effects of RO5545965 on the functioning of key brain circuitry involved~     in negative symptoms using functional magnetic resonance imaging (fMRI) and reward-based~     learning in stable participants with mild to moderate negative symptoms of schizophrenia~     treated with antipsychotics. Participants will be randomized to one of six different~     sequences during which each participant will receive three 3-week treatment courses with~     RO5545965 5 milligrams (mg), RO5545965 15 mg and placebo. Each treatment period will be~     separated by a washout period of 14 days. Total duration of study will be approximately 17~     weeks.~   "
56761|NCT02824042|"~     Characterize the safety, tolerability, ECG effects, pharmacokinetics and immunogenicity of~     anetumab ravtansine given as single agent and after inhibition of CYP3A4 and P-gp by~     concomitant administration of itraconazole in subjects with mesothelin-expressing advanced~     solid cancers~   "
56762|NCT02824029|"~     This phase II trial evaluates how effective 560 mg of ibrutinib taken by mouth daily is in~     the treatment of classical Hodgkin lymphoma which recurs or does not respond to initial~     treatment. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth, by altering the environment around the tumor or by affecting the~     immune system.~   "
56763|NCT02824016|"~     Prospective, multicentric, comparative, non randomised, in current care.~      Primary objective:~        -  To evaluate the incidence of hypothyroidism in breast cancer patients treated by~          radiotherapy including the supra-clavicular area over a period of 5 years (60 months).~      Secondary objectives :~        -  To calculate the dose of irradiation received by thyroid gland during the treatment.~        -  To compare the rate of incidence of hypothyroidism in women who received a~          supra-clavicular irradiation (group 1)and in those who did not (group 2).~        -  To estimate and compare the rate of incidence of chronic thyroid lesions in the 2~          groups.~        -  To look for predictive factors of hypothyroidism de novo in group 1 women particularly~          regarding the dose-volume parameters.~        -  To propose recommendations for the thyroid follow-up after supra-clavicular irradiation.~   "
56764|NCT02824003|"~     The purpose of this study is to evaluate the effect of ISIS 449884 (ISIS-GCGRRX) on Hepatic~     Lipid and Glycogen Content in patients with Type 2 Diabetes being treated with Metformin.~   "
56802|NCT02823509|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
56803|NCT02823496|"~     To evaluate the potential of a test material to produce a photoallergic response.~   "
56765|NCT02823990|"~     This phase II trial studies how well TG4010 and nivolumab work in previously treated patients~     with non-small cell lung cancer. Vaccines that are made from a gene-modified virus, such as~     TG4010, may help the body build an effective immune response to kill tumor cells. Monoclonal~     antibodies, such as nivolumab, interfere with the ability of tumor cells to grow and spread.~     Giving TG4010 and nivolumab together may work better in previously treated patients with~     non-small cell lung cancer.~   "
56766|NCT02823977|"~     This study is designed to evaluate the addition of ketamine to dexmedetomidine as adjunctive~     therapies of severe alcohol withdrawal in medical ICU patients. Specifically, this study will~     assess whether the combination of ketamine and dexmedetomidine reduces the doses of~     conventional agents used for alcohol withdrawal while maintaining patient comfort and safety~     and will explore if the combination alters the expression of catecholamines in the serum over~     time.~   "
56767|NCT02823964|"~     Liprotamase consists of 3 soluble, non-porcine digestive enzymes, lipase, protease, and~     amylase, combined in a fixed ratio. Liprotamase is stable in the stomach and can be~     formulated without enteric coating for administration either as a capsule or as a dosing~     solution dissolved in water or juice.~   "
56768|NCT02823951|"~     The purpose of this study is to evaluate the proportion of patients who demonstrate no~     medical need to discontinue therapy among DMT-naïve patients with relapsing forms of multiple~     sclerosis after 1 year of treatment with Rebif 44 mcg tiw or with Tecfidera 240 mg bid based~     on real-world data.~   "
56769|NCT02823938|"~     In France, a person consumes an average of 48 boxes of medicines per year (ANSM 2012). Among~     these substances, some, not prescribed in an indication related to cognitive function,~     however, will influence thereon.~      Several drug candidates with potential preventive effects have already been explored with~     little success (statins, antihypertensives, NSAIDs, aspirin, steroid hormones). Other studies~     have suggested the existence of deleterious cognitive effects of certain substances~     (benzodiazepines, anticholinergics, anti-cancer chemotherapy). However, only the effects of a~     limited number of drugs were analyzed, and most drugs have not been specific study in~     epidemiology.~      The study of this research theme has often been restricted by the limited size of the cohort~     of staff, not allowing the study of sometimes rare drug exposures, and poverty of the~     information collected on drug exposures. Thus, most studies focuses on families of molecules~     among the most prescribed. In addition, we now know that the pathophysiological process~     underlying Alzheimer's disease (representing 2/3 of dementia), actually begins more than 10~     years before the diagnosis of dementia. It is therefore essential to have a setback of~     several years between drug exposure and diagnosis of dementia to assess their role in the~     genesis and evolution of the disease.~      The Generalist Sample Beneficiaries (EGB) is a database containing data of health insurance~     and those of medicalization program of information systems (PMSI) for a sample of 550 000~     subjects enrolled in the general scheme of the insurance since 2004 and followed for a period~     of 20 years.~   "
56770|NCT02823925|"~     Multicentric osteolysis, nodulosis and arthropathy (MONA) spectrum disorder is a rare~     inherited progressive skeletal disorder caused by mutations in the matrix metalloproteinase 2~     (MMP2) gene. Treatment options are limited. The investigators reviewed the outcome of~     patients affected with MONA and treated with intravenous bisphosphonates in the clinical~     Center.~   "
56771|NCT02823912|"~     The increased mortality from cardiovascular disease has a significant impact on the~     population, and the prevalence of these diseases it become one of the major problems, since~     it is the leading cause of mortality and 1 in 3 Mexicans suffer from cardiovascular disease~     according ENSANUT; the above is attributed to the increase of diseases associated with an~     inflammatory process accelerated as obesity, dyslipidemia, hypertension (SAH) and diabetes~     mellitus (DM).~      The cholesterol is a major risk factor in the development of cardiovascular disease, and in~     turn increases the chances of death; however, the treatment of choice is based on changes in~     lifestyle, which for most people are difficult to maintain long-term. As for the drug therapy~     treated with drugs many people do not achieve their therapeutic goals, and therefore the~     inflammatory condition that underlies this disease remains.~      Recent studies have focused on the possible role of capsaicin in the inflammatory state~     through the agonistic effect it has on TRPV1. It has demonstrated the antiinflammatory~     activity of capsaicin to enhance inflammation by free fatty acids (FFA) and reducing the~     expression of certain genes involved in this process induced. Capsaicin is a natural choice~     and well tolerated with few side effects limited to the gastrointestinal tract such as~     dyspepsia and intestinal irregularity, for the above is of interest to evaluate the effect of~     capsaicin on the profile of inflammatory cytokines in individuals with dyslipidemia.~   "
56772|NCT02823899|"~     Cholera, a rapidly dehydrating watery diarrheal disease transmitted through water or food~     contaminated with the bacterium, Vibrio cholerae, is a major cause of morbidity and mortality~     in low income countries like Bangladesh. In our country, Cholera disease burden consists of~     both cholera outbreaks and endemic cholera comprising at least 300,000 severe cases and 1.2~     million infections each year. To combat this situation, Vaccination against cholera has been~     proved effective both in endemic and epidemic settings. But, the WHO recommended Dukoral and~     Prequalified Shanchol are quite expensive for our country perspective. Therefore, locally~     manufactured OCV can improve the cost effectiveness and make it affordable for all. The~     hypothesis of this proposal is that Locally produced orally administered whole cell~     inactivated HL-OCV test formulations A and B are safe and immunogenic in adults and children~     in Bangladesh as compared to ShancholTM. The results of the study will allow us to understand~     the safety and immunogenicity outcome of the HL-OCV compared to Shanchol vaccine. The total~     sample size will be 840 healthy participants. 840 healthy participants (360 adults, 240~     Children and Adolescent and 240 young children) of 18-45 years, 5- less than 18 years and 1~     year to less than 5 years will be enrolled in the study. Children whose parents/guardians~     give voluntary consent will be enrolled in the study. The investigators will provide 2 dose~     of vaccine for three groups in 14 days interval. Test formulations will be locally~     manufactured and the comparator group will get Shanchol. The Investigators propose to collect~     three blood samples (Day 0, 14 and 28).~   "
56804|NCT02823483|"~     To determine the phototoxic potential of a topically applied article in human subjects~   "
56915|NCT02822027|"~     Infection and inflammation is related to increased encephalopathy of prematurities.~   "
56773|NCT02823886|"~     An intense inflammatory reaction is triggered by the ischemic injury during myocardial~     infarction. The inflammatory processes involved are complex and haven't been explored in~     detail in human patients. This inflammatory response can increase myocardial damage following~     reperfusion, leading to adverse remodeling and adverse events (heart failure, sudden cardiac~     death).~      Cardiac MRI can assess the size of myocardial infarction and many other parameters associated~     with myocardial injury: edema, hemorrhage, micro-vascular obstruction.~      (However the association between biomarkers of inflammation and these imaging parameters is~     not known).~      There is very little data correlating imaging markers of myocardial injury to the biokinetics~     of inflammation biomarkers.~      In this study, the aim is to assess the relationship between the kinetics of specific~     inflammatory biomarkers (interleukin-1beta, interleukin 6, interleukin 17, Tumor Necrosis~     Factor (TNF)-alpha, C reactive protein (CRP), soluble toll-like receptor-2 (ST2),~     neutrophils) and imaging markers of injury measured by cardiac MRI at the acute phase in 20~     acute mycardial infarction (AMI) patients.~   "
56774|NCT02823873|"~     The purpose of this study is to test the accuracy of the Pulsewave wrist blood pressure cuff~     in pregnant and postpartum women who have either normal blood pressure or high blood~     pressure.~   "
56775|NCT02823860|"~     To access to good quality biological samples is a prerequisite for high level translational~     research. The BIG-RENAPE study has been established by the French hyperthermic~     intraperitoneal chemotherapy centers involved in the management of peritoneal surface~     malignancies.~      The main BIG-RENAPE study aim is to create a large multicentric and prospective repository~     for biological and tissue samples, which will provide a source of materials for a wide array~     of health related research studies - BIG-RENAPE Biobank-based research: i) validating known~     and promising biomarkers; ii) identifying new predictive and prognostic factors; iii)~     evaluating the impact of current health care strategies; iv) standardizing diagnostic and~     therapeutic management through guidelines; v) developing new drugs.~      The BIG-RENAPE Biobank is certified according to NFS 96-900 as a service of processing,~     storage and transfer of high quality biological (plasma, serum, buffy coat) and tissue~     (formalin-fixed-paraffin-embedded) samples. Biospecimens are collected at each stage of~     diagnostic and therapeutic care. The patient and his derivates are anonymized and registered~     in a national web database reporting disease status, treatments, surgical procedures,~     pathological diagnosis, quality of life's assessment and long term follow-up. All~     participants have given their informed consent before any sample. The BIG-RENAPE study was~     approved by the local Ethical Committee, based on the assessed compliance to French~     regulatory rules.~   "
56776|NCT02823847|"~     The goal of this clinical research study is to learn how a new method for performing oral~     (mouth) exams can help doctors check for suspicious lesions (called premalignant and~     malignant oral lesions [PMOL]) in the mouth of HIV-infected smokers.~   "
56777|NCT02823834|"~     MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to~     evaluate the safety and efficacy of its total hip arthroplasty (THA) components marketed in~     the European Union (EU). These types of studies are required by regulatory authorities for~     all THA devices that do not have medium to long-term clinical evidence available at the time~     of gaining approval to market in the EU. This study has been designed in accordance with the~     medial device directives (MEDDEV) 2.12/2 rev 2.~   "
56778|NCT02823821|"~     This global study will assess the effect of randomising dialysis sites to one of two default~     dialysate sodium concentrations in current practice, 140mmol/l and 137mmol/l, on major~     cardiovascular events and death in patients receiving maintenance haemodialysis.~   "
56779|NCT02823808|"~     All subjects will be randomized as Alo/Pio combo group (intervention) or Glim/Met combo group~     (control) after intensive COAD treatment based on identical protocol.~        -  All subject will be managed with once daily, fixed dose, single tablet treatment based~          on the study protocol, and followed-up for 104 weeks.~        -  Any group of subjects who fail to reach glycemic target with single tablet treatment,~          subject will be treated with rescue medication and stopped regular observation.~   "
56780|NCT02823795|"~     This study evaluates if motivational interviewing sessions aiming to motivate recently~     discharged patients with either chronic obstructive pulmonary disease or congestive heart~     failure to be active in post-discharge self-management can reduce re-hospitalization rates.~   "
56781|NCT02823782|"~     Impulsivity and/or hyperactivity in children has become one of the main clinical symptom for~     consultation, among the most frequent, in general or pediatric medicine. Among the different~     clinical forms of instability, ADHD appears to be an especially disabling condition for the~     development of the child, both in psychomotor, cognitive, emotional and relational aspects.~     Further, a significant link between ADHD children and some children with High Potential (HP)~     is observed. HP children show overall ahead cognitive developments compared to children with~     the same age. In these children, as well as in children with ADHD, an attention~     vulnerability, psychomotor deficits are noted, as well as emotional and relational deficits~     that significantly contrasted with some of their cognitive skills. Regarding the HP, the~     hypothesis is that children with significantly heterogeneous results (Complex) to the~     Wechsler IV scales are affected by this shift, and hence, by the difficulty of a differential~     diagnosis with ADHD, unlike those whose intelligence quotient (IQ) results that are more~     homogeneous (Laminar).~      The goal of this work was to study a population of 80 children aged from 8 to 12 years (20~     subjects per group) to evaluate the functional and structural brain development by:~        -  Functional magnetic resonance imaging (fMRI) acquisitions with cognitive stimulations,~          involving attention, working memory and semantic processing, and emotional stimulations,~        -  fMRI acquisitions at rest (without activation),~        -  diffusion tensor magnetic resonance imaging (DTI) acquisitions,~        -  3D anatomic acquisitions. Identification of developmental differences in certain~          cortical brain areas (eg, prefrontal vs parietal), white matter fiber bundles or~          functional networks preferentially used by one or other of these groups, will help to~          better understand this disease, and to improve the differential diagnosis in order to~          implement a more appropriate and personalized management of the patients via new~          therapeutic strategies.~   "
56805|NCT02823470|"~     The study will evaluate the impact of smart adherence technology for monitoring on~     lumacaftor/ivacaftor (LUM/IVA) adherence rates among subjects 16 years of age and older with~     Cystic Fibrosis (CF) who are homozygous for the F508del Cystic Fibrosis Transmembrane~     Conductance Regulator (CFTR) mutation.~   "
56806|NCT02823457|"~     This study implement a values-based motivational interviewing (VBMI) intervention to promote~     treatment completion with fixed dose combination (FDC) MK-5172/MK-8742 x 12 weeks among 30~     Veterans with substance use disorder (SUD) and treatment naïve genotype 1 chronic hepatitis C~     virus (HCV) infection.~   "
56896|NCT02822287|"~     This is a 1-treatment arm, open label design. This 1-day study includes a screening on day of~     attendance at clinic, followed by a washout period of 30 minutes to 8 hours (if participants~     are eligible for dosing the same day). The study also includes a supervised dosing with 10 mL~     oral solution and a 1 hour in-clinic evaluation period.~   "
56782|NCT02823769|"~     Despite the advances in adhesive restorative techniques and materials, dental caries still~     remains a critical concern even today. In addition, recurrent caries related to microleakage~     is a common mode of failure of directly placed resin composite restorations. Resin composites~     are particularly susceptible to recurrent caries due to polymerization contraction and also~     imperfect adhesion of restorative to tooth tissue. Thus, strong durable bond between adhesive~     restoratives and tooth tissue and increasing the resistance of teeth to acid by encouraging~     the development of remineralization are essential to withstand secondary caries. Fluoride has~     been documented as a major contributing factor for the decline in the incidence of dental~     caries and also it has been accepted as an agent in the prevention of caries. Giomers are a~     new group of anhydrous resin based direct adhesive restorative materials based on the filler~     technology (PRG) have both advantages of glass ionomers namely, fluoride release and~     recharge, and resin composites with excellent optical and mechanical properties. The~     chemistry of Giomer materials facilitates fluoride ion release with the potential for a lower~     incidence of recurrent caries that was accepted as a major factor to retreat a resin~     restoration. Limited number of studies is available on their fluoride release, and~     polishability, as well as clinical survival.~      The objective of this controlled clinical trial is to evaluate the clinical performance of~     restorative material SI-R21204 resin composite versus a nano-hybrid resin com-posite~     materials for Class I and Class II cavities that needs to be restored in per-manent teeth.40~     patients are recruited to the project which is carried out at the School of dentistry,~     Istanbul Medipol University, Turkey.~   "
56783|NCT02823756|"~     The primary purpose is to examine the impact that physical therapy (PT) interventions,~     including manipulations, have on physical activity levels outside of the clinical environment~     in persons with low back pain (LBP) as measured both objectively with an accelerometer and~     subjectively with questionnaires.~      The secondary purpose is to determine if a relationship exists between objective physical~     activity, self-perceived disability pain catastrophizing thoughts, BMI, age, six-minute walk~     distance, lower extremity muscle endurance.~      The tertiary purpose is to assess the predictive value that a standing manual lumbar~     unloading technique has for relief of pain following manipulation~   "
56784|NCT02823743|"~     The aim of this study is to examine whether treatment with 75 mg aspirin daily compared with~     placebo could reduce the risk for a new miscarriage. The treatment starts when the pregnancy~     is detected on transvaginal ultrasound (around gestational week 6+) and continues to week~     35/36. The study is a single center, randomized, placebo-controlled, double blind and~     stratified for age. 400 participants with the diagnosis idiopathic recurrent abortion are~     enrolled, 200 in each arm aspirin / placebo.~   "
56785|NCT02823730|"~     To compare the incidence of major adverse cardiac events among a series of patients receiving~     the Synergy drug-eluting stent with bioabsorbable polymer to historical controls who have~     received the Promus Premier drug-eluting stent with durable polymer.~   "
56786|NCT02823717|"~     Perineal tear grade III and IV are relatively common (1-10% of deliveries depending on the~     series), and are a source of potentially serious complications, even long time after delivery~     (especially disorders of anal continence, psychological trauma). If a number of risk factors~     are well described, the support arrangements at the time of delivery and the characteristics~     of the review Proctological remote delivery and its relationship to the clinical status of~     patients is little known and rarely studied.~      In maternity wards of the hospital Saint Joseph Paris and Cochin-Port Royal group, patients~     with a diagnosis of severe perineal tear was made are taken following load with common rules,~     both for the immediate repair for the remote monitoring. Patients of both sites are indeed~     encouraged to consult in proctology consultation in Saint Joseph 4-6 months of birth.~      The same support on both sites allows to consider the creation of a relatively homogeneous~     cohort in terms of support and consider an important recruitment. Moreover, the geographical~     proximity of the inclusions sites (maternity) with proctology service is likely to limit the~     risk of lost sight of.~   "
56787|NCT02823704|"~     The study ia aiming to the assessment of Mid-Regional proadrenomedullin (MR-proADM) as a~     novel biomarker that can provide accurate short-, mid- and long term prognostic information~     in the triage and multi-dimensional risk assessment of patients in the Emergency Department~     (ED). A clinical algorithm with predefined MR-proADM cut-off values: <0.75 nmol/L (low risk),~     0.75 nmol/L≥ and ≤ 1.5 nmol/L (intermediate risk); >1.5 nmol/L is pre-defined. Based on these~     cut-off values, a prespecified algorithm aiming to predict i) reduction of hospitalization in~     the ward/ICU and increase of out-patient treatment (rule-out of risk); and ii) reduce adverse~     complications (identify patients at risk) will be applied and compared with the initial~     clinical decision.~   "
56788|NCT02823691|"~     This is a Pilot, One-arm, Open-label, Prospective Study to evaluate Safety of Lanreotide 120~     mg ATG in combination with Metformin in patients with advanced progressive GI or lung~     carcinoids.~      The patient population will include patients with a histologically documented diagnosis of~     Well differentiated NET, G1-G2 according to the last WHO Classification criteria for GI and~     lung NET carcinoids.~   "
56789|NCT02823678|"~     This study will enroll 100 patients scheduled to undergo a pancreatectomy.~      The primary objective is to develop a scoring system using pancreatic volume measured by CT~     scan and intraoperative measurements of the pancreas parenchyma to predict the onset of~     diabetes mellitus after a pancreatectomy. The investigators will also monitor patients with~     pre-existing diabetes to see if their diabetes worsens or improves.~   "
56790|NCT02823665|"~     The purpose of this study is learn the effect of gastric bypass surgery and sleeve~     gastrectomy on glucose metabolism mediated by neural and hormonal factors initiated after~     eating.~   "
56791|NCT02823652|"~     This research trial studies how well pre-test genetic education and remote genetic counseling~     works in communicating tumor profiling results to patients with advanced cancer. Web-based~     genetic education before receiving tumor profiling results and remote genetic counseling for~     patients with potential germline mutations may increase genetic knowledge and reduce distress~     for patients with advanced cancer.~   "
56831|NCT02823132|"~     The aim of this study is to investigate levels of a protein, mannose binding lectin, in~     patients with acute leukemia who develop or not an invasive fungal infection.~   "
56832|NCT02823119|"~     The aim of this study is to evaluate the effect of hysteroscope diameter on the pain~     experienced by nulliparous patients undergoing diagnostic office hysteroscopy.~   "
56792|NCT02823639|"~     Impairments of cognition are a core, severely disabling feature of schizophrenia leading to~     poor long-term outcome with no established treatment available.~      Particularly impaired executive functions (e.g working memory) are frequently observed and~     are consistently associated with reduced activation of the dorsolateral prefrontal cortex~     (dlPFC). Deficits in those functions have been shown to be closely related to negative~     symptoms, thought disorder, and functional outcome in schizophrenia leading to the notion~     that frontal lobe dysfunction is crucially important in schizophrenic psychopathology.~      Noninvasive brain stimulation like tDCS can enhance executive functions like working memory~     in healthy subjects as well as in patients. To identify the optimal parameters for this~     intervention in patients with schizophrenia, the investigators first test the effects of~     different polarities (anodal, cathodal), stimulation intensities (1mA, 2mA) and laterality~     (left, right) on working-memory performance (nback task) in a sham-controlled cross-over~     design (n=128). To elucidate mechanisms of action, oscillatory brain activity will be~     registered with electroencephalography (EEG).~      These experiments will provide reliable data for an evidence-based development of new~     clinical interventions to improve treatment of cognitive deficits in patients with~     schizophrenia and thus enhance schizophrenia prevention and recovery.~   "
56793|NCT02823626|"~     Primary Aims~        1. Evaluate the safety of high-dose spironolactone in combination of patiromer in acute~          decompensated heart failure patients.~        2. Evaluate the efficacy of high-dose spironolactone in combination of patiromer in causing~          volume loss and symptom relief in patients with ADHF treated with high-dose~          spironolactone.~      Secondary Aims~      1: Evaluate the effect of high-dose spironolactone on urinary sodium excretion and renal~     function.~   "
56794|NCT02823613|"~     The hypothesis is that changes in the epithelial sodium channel (ENaC) in the kidney is~     reflected in urinary exosomes and that the amount of ENaC as well as the cleavage degree is~     upregulated in conditions with low salt.~   "
56795|NCT02823600|"~     The purpose of this research study is to look at retinal abnormalities in outpatient renal~     dialysis patients using the FDA approved RetinaVue 100 hand-held (non-mydriatic) camera.~   "
56796|NCT02823587|"~     The purpose of this study is to assess the effect of pulmonary rehabilitation on the~     transport of secretions, inflammation and respiratory resistance, and its repercussions on~     the quality of life in patients with bronchiectasis.~   "
56797|NCT02823574|"~     A study in patients with metastatic or recurrent squamous cell cancer of the head and neck to~     evaluate the effectiveness of Nivolumab plus Ipilumumab vs. Nivolumab alone (CheckMate 714)~   "
56798|NCT02823561|"~     Obesity is one of the greatest public health challenges of the 21st century. Its prevalence~     has tripled in many countries of the European Region since the 1980s, and the numbers of~     those affected continue to rise at an alarming rate. In addition to causing various physical~     disabilities and psychological problems, excess weight drastically increases a person's risk~     of developing a number of noncommunicable diseases including cardiovascular disease, cancer~     and diabetes, in association or not to metabolic syndrome. The risk of developing more than~     one of these diseases (co-morbidity) also increases with increasing body weight. Every year a~     growing number of patient tend to suffer of more severe obesity and difficulty in losing~     weight even with a restricted diet and exercise.~      Garcinia mangostana (Sphaeranthus indicus extract) has known for its antioxidant properties;~     new evidence point out some promising effects in the prevention of lipogenesis and the~     promotion of lipolysis . Currently in the scientific literature there is only one paper, by~     Stern et al., showing the association of Garcinia mangostana assumption in low-calorie diet.~     This work has demonstrated a significant reduction in weight loss , compared to the placebo~     group,due to the use of Garcinia mangostana.~      Aim of the present study is the evaluation of safety and efficacy of weight loss in severe~     obese patients. Also cardiometabolic parameters and flogosys serum indicators will be~     evaluated before and after 6 month therapy of low calory diet alone or in association with~     Garcinia mangostana extract.~   "
56799|NCT02823548|"~     PICASSO has been designed to demonstrate that combination therapy with CS/GH has superior~     efficacy compared to placebo in pain reduction (average score reduction in Huskisson's 0 to~     100 mm Visual Analogue Scale) from baseline to 6 months of treatment in patients with~     symptomatic hand osteoarthritis.~   "
56800|NCT02823535|"~     The overarching objective of this proposal is to conduct a randomized trial to evaluate the~     effectiveness of the Individual Well-Being Navigator (Iwin) mobile application, a substance~     abuse prevention and well-being enhancement program designed specifically for military~     personnel, veterans, and military spouses. Iwin provides an innovative, tailored mobile~     application using best practices in behavior change science and innovative technology to~     assist users in preventing substance abuse and enhancing well-being by providing them with~     the most appropriate intervention content at the right time. It integrates Transtheoretical~     Model of Behavior Change based tailoring, in app messaging, stage of change matched~     activities, and engaging game-like features in a cutting edge multiple behavior change~     program. The efficacy of the Iwin program will be determined by tests of statistical~     significance indicating that participants in the Treatment condition had lower scores on an~     index of substance use and other behavioral risks. The overall design is a 2 group (treatment~     and control group) by 3 Occasions with repeated measures across occasions.~   "
56801|NCT02823522|"~     Non-Celiac Gluten Sensitivity (NCGS) has been recently included among the gluten-related~     diseases. Patients suffering from NCGS are diagnosed after carefully excluding celiac disease~     (CD), and immunoglobulin E (IgE)-mediated wheat allergy. Then, in the absence of sensitive~     and specific diagnostic biomarkers for NCGS, a monitoring of the patient during elimination~     and re-introduction of wheat by a double-blind placebo controlled (DBPC) challenge method has~     been suggested as diagnostic hallmark. Some studies seem to suggest that wheat components~     other than gluten can cause the symptoms, and therefore the term non-celiac wheat~     sensitivity (NCWS) has been proposed instead of NCGS. While it is well known that CD is a~     long-life condition and a strict adherence to the gluten-free diet must be maintained, it is~     unknown whether this is valid for NCWS. On the year 2012, the researchers published a~     retrospective study, including 276 patients with irritable bowel syndrome (IBS)-like symptoms~     who had been diagnosed with NCWS using a DBPC challenge during a ten-years period~     (2001-2011). The present prospective study aimed to evaluate: A) how many of these patients~     are still following a wheat-free diet, and B) which percentage was still suffering from NCWS,~     diagnosed by DBPC wheat challenge, in a subgroup of that cohort.~   "
56807|NCT02823444|"~     To systematically develop, test, and refine peripheral vascular electrocardiography-gated~     fast spin echo magnetic resonance imaging for the accurate diagnosis of peripheral arterial~     disease without gadolinium contrast.~      To test prospectively the accuracy of fast spin echo in peripheral arterial disease patients,~     compared with bolus-chase and time-resolved gadolinium enhanced magnetic resonance~     angiography. Additionally, as a substudy of this project, we will compare our fast spin echo~     approach with alternative non-contrast-enhanced magnetic resonance imaging methods such as~     time-of-flight and steady-state gradient echo imaging.~      The overarching goals of our research are to develop and validate a peripheral magnetic~     resonance imaging technique that accurately depicts anatomy and disease without exposing~     patients to exogenous contrast material and its associated risks.~   "
56808|NCT02823431|"~     The purpose of this study is to evaluate how urethral analgesia impacts voiding efficiency in~     healthy women. The investigator hypothesizes that anesthetizing the urethral with lidocaine~     gel will decrease voiding efficiency as measured by standard bladder testing (urodynamic~     testing).~   "
56809|NCT02823418|"~     Postpartum depression (PPD) affects approximately 15% of women during the first year after~     giving birth, and is common across cultures. The etiology of postpartum depression is not~     totally clear. The severe pain experienced during childbirth was reported to be associated~     with the development of postpartum depression. The purpose of the present study is to~     evaluate whether use of neuraxial labor analgesia can reduce the incidence of postpartum~     depression.~   "
56810|NCT02823405|"~     The goals of this protocol are 1) to investigate the safety and tolerability of X4P-001 in~     combination with Keytruda® (pembrolizumab) in patients with advanced melanoma, and 2) to~     assess serial biopsies of melanoma tumor lesions obtained throughout the study for~     inflammatory and tumor cell infiltrates. After completion of study treatment, patients with~     resectable disease will undergo surgery, unresectable patients may continue on pembrolizumab~     as standard of care.~   "
56811|NCT02823392|"~     Unanticipated difficult airway comprises of unexpected difficult bag mask ventilation or~     unforeseen difficult laryngoscopy. The incidence of difficult laryngoscopy or unanticipated~     difficult intubation in children was varied from 1.2 %to 4.77% depending on general or~     specific population and type of surgery. The known risk factors of difficult intubation in~     children were young age, associated syndrome or congenital abnormality and obstructive sleep~     apnea. Moreover, the predictors of difficult laryngoscopy by physical examination were~     associated with short interincisors distance, high frontal plane to chin distance, short~     thyromental distance and Cormack & Lehane classification 3 or 4. However, little knowledge is~     known regarding difficult bag mask ventilation in children. The incidence of difficult bag~     mask ventilation was 6.6% according to the single study. A few study reported the independent~     risk factor of difficult bag mask ventilation in children which were young age, obesity, use~     of neuromuscular blocking agent and airway surgery. In addition, the association between~     difficult bag mask ventilation and difficult intubation are still unknown. To understand more~     of difficult bag mask ventilation in children and factor-association may reduce incidence of~     morbidity and mortality by identifying difficult airway, preparing personnel and equipment~     tool in order to improve clinical outcome in pediatric anesthesia. The objectives of the~     study were to determine the predictors of difficult bag mask ventilation and the association~     with unexpected difficult intubation in children who came for elective surgery in tertiary~     care hospital of southern Thailand.~   "
56812|NCT02823379|"~     The purpose of this project is to test an 8-month, culturally relevant, Smartphone-delivered~     PA program to improve and maintain high physical levels and reduce cardiometabolic disease~     risk among obese AA women.~   "
56813|NCT02823366|"~     Ursodeoxycholic acid (UDCA) has been the only treatment for PBC approved by US and European~     drug administrations. Long-term use of UDCA(13—15 mg/kg/day) in patients with PBC improves~     serum liver biochemistries and survival free of liver transplantation However, about 40% of~     patients do not respond to UDCA optimally as assessed by known criteria for biochemical~     response. Those patients represent the group in need for additional therapies, having~     increased risk of disease progression and decreased survival free of liver transplantation.~     Both lab research and some clinical studies suggest that fenofibrate could improve~     cholestasis in multiple ways including reduce of bile acid synthesis, increase of biliary~     secretion and anti-inflammation effect. Here we start a random, open and parallel clinical~     research to explore the effect of fenofibrate in the PBC treatment.~   "
56814|NCT02823353|"~     Ursodeoxycholic acid (UDCA) has been the only treatment for primary biliary cirrhosis (PBC)~     approved by US and European drug administrations. Long-term use of UDCA(13—15 mg/kg/day) in~     patients with PBC improves serum liver biochemistries and survival free of liver~     transplantation However, about 40% of patients do not respond to UDCA optimally as assessed~     by known criteria for biochemical response. Those patients represent the group in need for~     additional therapies, having increased risk of disease progression and decreased survival~     free of liver transplantation. Both lab research and some clinical studies suggest that~     fenofibrate could improve cholestasis in multiple ways including reduce of bile acid~     synthesis, increase of biliary secretion and anti-inflammation effect. Here we start a~     random, open and parallel clinical research to explore the effect of fenofibrate in the PBC~     treatment.~   "
56815|NCT02823340|"~     Twenty patients with PAH had 1 session of Fractionated microneedle radiofrequency treatment.~     Clinical improvement was evaluated using a Hyperhidrosis Disease Severity Scale (HDSS) and~     photographs were taken using the starch-iodine test at every visit and 4 weeks, 8 weeks, and~     24 weeks after the treatment. Skin biopsies were obtained from 3 of the enrolled patients~     before and after treatment. The satisfaction and adverse reactions of the research~     participants were recorded at every follow-up visit.~   "
56816|NCT02823327|"~     This research trial studies clinical factors and gene expression analysis for prognosis in~     tissue samples from patients with acquired immune deficiency syndrome (AIDS)-related primary~     effusion lymphoma. Gathering health information over time and studying samples of tissue from~     patients in the laboratory may help doctors learn about the prognosis of patients with~     AIDS-related primary effusion lymphoma.~   "
56817|NCT02823314|"~     Nausea and vomiting are two of the side effects associated with the most common~     antineoplastic chemotherapy treatments. The Medical Taping Concept (MTC) is an economical~     technique, easy to apply. This is a technique that may help reduce nausea and vomiting after~     application of chemotherapy in cancer patient.~   "
56818|NCT02823301|"~     The main purpose of this study is to evaluate the effectiveness and the maintenance of a~     behavior change program called VAMOS (Active Life Improving Health) Program on physical~     activity and healthy eating habits in different environmental contexts of Florianópolis/ SC/~     Brazil. This study will be conducted in Health Centers (HC) of Florianópolis/ SC/ Brazil,~     defined according to environmental and income characteristics. Therefore, initially all~     geographic areas around the HC will be visited to classify the public places as favorable~     (with the presence of spaces for the practice of PA) and unfavorable environmental (do not~     have spaces for physical activity). Thereafter, four HC will be selected: high income + high~     environmental quality index, high income + low environmental quality index, low income + high~     environmental quality index, low income + low environmental quality index. In each HC, the~     volunteers will be randomly assigned into two groups of approximately 25 people: VAMOS group~     and control group. The participants that will be assigned to the VAMOS group will participate~     in a behavioral change program aimed at motivating changes in physical activity and eating~     habits during five months (12 meetings - six weekly meetings and six fortnightly meetings),~     while the control group will receive one educational lecture regarding lifestyle changes. The~     meetings of VAMOS Program will be held in the dependences or nearby the HC and will be~     mediated by the physical education professional previously trained. The Program will be~     evaluated by the RE-AIM framework: reach, effectiveness, adoption, implementation and~     maintenance. The effectiveness will be assessed from measurements of physical activity,~     eating habits, self-efficacy, social support, quality of life, anthropometry, and lipid~     profile before and after five months of intervention. The implementation will be assessed by~     identifying the extent to which the program will be conducted as planned. The maintenance~     will be estimated from revaluations of all outcomes, as measured before and after the~     intervention, six months and one year after the end of the program.~   "
56819|NCT02823288|"~     South Africa has one of the highest rates of violence towards women globally. However, little~     is known about how to prevent men's use of violence. The Sonke CHANGE Trial tests an~     intervention that targets men as individuals, groups, and community members in a peri-urban~     setting in South Africa. Eighteen neighborhoods will be randomly assigned to either the~     intervention condition or a control group. By speaking to men at baseline, 12 months, and 24~     months, investigators will learn whether violence and other health behaviors shift over time.~     Alongside the trial, qualitative research will explore how the intervention took place and~     why participants may change attitudes or behaviors.~   "
56820|NCT02823275|"~     Rationale: Ankle fractures are common traumatic lesions. In order to restore the anatomical~     situation of the ankle joint to prevent posttraumatic arthritis, these fractures often need~     surgical treatment. Both cast immobilisation and functional treatment have proved to be~     reliable postoperative treatment regimes. Insight into the quality of life and the level of~     pain is necessary to determine if these treatments can be related to higher patient~     satisfaction and earlier resumption of daily activities and work.~      Objective: The aim of this study is to examine two postoperative treatments for surgically~     corrected ankle fractures. Postoperative, direct functional mobilisation is compared to short~     term plaster cast fixation. The focus of this study is on quality of life, pain and the use~     of pain medication, and resumption of work and daily activities.~      Main study parameters/endpoints:~      Quality of life, Function, pain, swelling, daily activities and work, disabilities (pain~     disability index), complications~   "
56821|NCT02823262|"~     The purpose of this research study is to evaluate a decision aid to help women aged 70 and~     older decide on treatment for their breast cancer.~   "
56822|NCT02823249|"~     With this study the investigators investigate the effects of amino acids (tryptophan, leucin)~     and sugar alcohols (xylitol, erythritol) on satiety mechanisms and brain activation.~   "
56823|NCT02823236|"~     The aim of the study is to assess the efficacy and safety of the combination of intralesional~     triamcinolone (at doses of 4mg / cm2 at intervals of 4 weeks) and topical pirfenidone 8%~     (every 8 hours continuously) compared with their isolated application, in the treatment of~     keloid scars in adults. The duration of this three-arm clinical trial will be 12 months, a~     6-month period for treatment and a follow-up of 6 months to assess recurrences. The estimated~     number of persons to be recruited and randomized for the study is 102.~   "
56824|NCT02823223|"~     To compare the clinical outcomes of Endoscopic Lung Volume Reduction using Pulmonx Zephyr~     Endobronchial Valve (EBV) vs. Standard of Care (SoC) in the treatment of heterogeneous~     emphysema patients in a controlled trial design setting.~   "
56825|NCT02823210|"~     Myeloproliferative neoplasms (MPN) are clonal hematopoietic disorders sharing a common~     natural evolution: a chronic phase, characterized by a major risk of vascular events,~     followed by an accelerated phase eventually leading to transformation to acute leukemia. MPN~     include polycythemia vera, essential thrombocythemia, primary myelofibrosis, and rarer~     entities. During the past years, CML became a paradigm for targeted therapy and personalized~     cancer medicine. For other MPNs, the discovery of the JAK2V617F mutation followed by many~     other mutations, opened similar perspectives. However, several questions remain to be~     answered in MPNs regarding the clinical implication of these major scientific discoveries:~     what is the clinical impact of JAK2V617F and other molecular biomarkers on the risks of~     complications and progression? Can these new biomarkers be used in the perspective of a~     personalized therapy of MPNs? his project will focus on the qualification of a series of~     known mutations as biomarkers in MPNs based on large multicenter cohorts of patients with~     well-annotated samples~   "
56826|NCT02823197|"~     The purpose of this study is to determine whether a theory- and evidence-based intervention~     aiming to promote active transport for short distance travel among older adolescents is~     effective in increasing attitude, subjective norm, self-efficacy, awareness and habit towards~     active transport, and intention to use active transport after obtaining a driving license.~   "
56827|NCT02823184|"~     The aim of this study is to evaluate the endoplasmic reticulum stress markers as predictive~     for response to hydroxyurea in polycythemia vera (PV) and essential thrombocythemia (ET).~   "
56828|NCT02823171|"~     A Phase 1, Open-Label, Single-Dose, Randomized, 2-Period Crossover Study to Assess the~     Bioequivalence of Two Pacritinib Drug Product Formulations (Phase 3 Clinical Trial [P3CT]~     Formulation [Reference] and Final Market Image [FMI] Formulation [Test]) Following Oral~     Administration in Healthy Subjects~   "
56829|NCT02823158|"~     Deep brain stimulation (DBS) is an established treatment for advanced complicated Parkinson's~     disease (PD). Several controlled randomized studies have given proof of an advantage for~     operated patients as compared to medically treated patients in terms of motor outcome,~     activities of daily living and health status. However these studies have addressed mostly~     stimulation of the subthalamic nucleus (STN). GPi stimulation has not been compared to best~     medical treatment (BMT) in a prospective randomized controlled trial in patients with~     complicated PD who are not good candidates for STN stimulation. The investigators aim~     assessing GPi-DBS in patients with PD who have contraindications for STN-DBS.~   "
56830|NCT02823145|"~     This is an international, multicenter, open-label, long-term safety study of ZX008 in~     pediatric and young adult subjects with Dravet syndrome who have successfully completed 14~     weeks of treatment in the core study (ZX008-1501 and ZX008-1502).~   "
56833|NCT02823106|"~     This is a phase 1, blinded-outcome, randomized, placebo controlled study to investigate the~     safety and feasibility of super-selective intra-arterial administration of verapamil and~     citicoline immediately following successful endovascular thrombectomy as a potential~     neuroprotective synergistic therapeutic strategy in emergent large vessel occlusion stroke.~     This trial represents the first time that citicoline will be evaluated in human subjects as a~     superselectively administered neuroprotective agent administered in an acute time frame as an~     adjunct to intra-arterial thrombectomy. Furthermore, it will represent the first trial to~     evaluate combinational therapy for acute stroke neuroprotection.~   "
56834|NCT02823093|"~     The vitamin K antagonists (VKA) are necessary drugs of prevention and treatment of~     thrombo-embolic disease. The AVKAL study assesses the impact of VKA treatment on the aortic~     calcifications development. This is a biomedical research without health product, transversal~     and monocentric study which compares the aortic calcifications levels of two populations :~     one treated by VKA and the other which has never been treated by VKA.~   "
56835|NCT02823080|"~     To evaluate safety and efficacy of 3-day cetrotide therapy started on day of oocyte retrieval~     (Day-0) in women at high-risk for development of ovarian hyperstimulation syndrome (OHSS)~     after gonadotropin- releasing hormon agonist induction protocol.~      Patients & Methods: Forty-eight women fulfilling inclusion criteria underwent ultrasound~     scanning for maximal ovarian diameter (MOD) estimation and ascites grading. Patients~     underwent embryo freezing, but study group received 3-day Cetrotide sc injection (0.25~     mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value~     (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading~     were re-evaluated on Day-3, 6 and 8~   "
56836|NCT02823067|"~     The primary objective of this observational study is to describe the prevalence of pruritus~     and pemphigoid in nursing home patients. Secondary outcomes are the relationships of~     demographic factors and medical risk factors with pemphigoid, including dementia and~     neuropsychiatric symptoms, medication use and Karnofsky score.~   "
56837|NCT02823054|"~     Coronary artery bypass grafting is a current cardiac surgery. Internal thoracic artery is~     usually taking to restore coronary revascularization, and its dissection can lead to~     accidental or voluntary pleural effusions. Respiratory complications are frequent, due to the~     drainage required. In this study, the investigators propose one-lung ventilation to~     facilitate artery grafting and surgical procedure. The investigators will include all adult~     patients with elective coronary artery bypass surgery (CABG) by internal thoracic artery, in~     a prospective, controlled, randomized and monocentric study. The main objective is to~     demonstrate that one-lung ventilation using EZ-Blocker can reduce pleural effusion defined by~     presence of drainage and/or pneumothorax on X-ray chest in the ICU.~   "
56838|NCT02823041|"~     This is a confirmatory randomized controlled trial of the efficacy of a novel intervention~     combining neuroplasticity-based cognitive training with aerobic exercise, compared to the~     same systematic cognitive training alone. Treatment occurs for 6 months after randomization,~     with a followup assessment at 12 months. The investigators hypothesize that combining~     neuroplasticity-based computerized cognitive training and neurotrophin-enhancing physical~     exercise will produce neurotrophin increases and cognitive and functional improvements, even~     relative to cognitive training alone. The investigators target the period shortly after a~     first episode of schizophrenia to maximize the generalization of cognitive improvement to~     functional outcome, before chronic disability is established.~   "
56839|NCT02823028|"~     Tweet2Quit is an innovative smoking cessation intervention that combines real-time online~     peer-to-peer support with auto messaging. In a three-group randomized controlled trial, the~     investigators will compare: 1) usual care, 2) Tweet2Quit-coed, and 3) Tweet2Quit-Women only.~   "
56840|NCT02823015|"~     Persistent pain after breast cancer surgery (PPBCS) is a significant clinical problem,~     affecting between 25 and 50% of patients. Several factors are associated with the development~     of PPBCS, including acute postoperative pain. The analysis of pain trajectories through mixed~     model modeling is an alternative to static pain measures, improving precision and providing~     information on the time course of pain resolution. Our aim was to investigate if the~     characteristics of pain trajectories during the first postoperative week are correlated with~     the persistence of pain 3 months after breast cancer surgery.~   "
56841|NCT02823002|"~     This study will collect data from multiple academic institutions. The primary objective for~     part A of this study is to determine the impact of anesthetic injection rate and temperature~     on pain perception during dermatologic procedures, and the objective for the part B of this~     study is to determine if buffering of the anesthetic solution alters pain perception.~      This study is a pilot study designed to determine feasibility of these procedures.~   "
56842|NCT02822989|"~     Systemic Lupus Erythematosus (SLE) is a chronic autoimmune, inflammatory disease and~     musculoskeletal pain is one of the most common symptoms. This study will investigate whether~     transcutaneous stimulation of the vagus nerve will decrease lupus musculoskeletal pain. This~     study will additionally investigate the biologic effects of vagus nerve stimulation on~     inflammation. It will be the first clinical study using one of the body's own pathways of~     modulating the immune system and inflammatory response, the cholinergic anti-inflammatory~     pathway, in SLE.~   "
56843|NCT02822976|"~     Background: Glycated hemoglobin A1c (HbA1c) has been linked to poor outcomes in the cardiac~     surgery, septic and critically ill patient population. It is a promising test to understand~     the complex relationship between glycemia, diabetes and outcomes in patients admitted to the~     intensive care unit.~      Hypothesis: An elevated HbA1c value on admission to an intensive care unit (ICU) is~     associated with poor outcomes.~   "
56844|NCT02822963|"~     Benign prostatic hyperplasia(BPH) is a common disease in urology among old men. If BPH~     symptom cannot be controlled by drugs, then transurethral resection of the prostate (TURP),~     is recommended. Although the procedure is quit safe, these old men often take anticoagulants~     and antiplatelets to control cardiovascular diseases, which arose some concerns for their~     bleeding risk. The management of anticoagulation in patients undergoing surgical procedures~     is challenging because interrupting anticoagulation increases the risk of thrombotic events.~     At the same time, surgery and invasive procedures have associated bleeding risks that are~     increased by the anticoagulant administration. Now, the recommendation about anticoagulants~     and antiplatelets discontinuation had no concrete evidence, especially in TURP. Furthermore,~     there is no relative studies done in Taiwan population, which calls for further~     investigation.~   "
56845|NCT02822950|"~     The purpose of this study is to analyze the PK/PD of AvyCaz in critically ill patients in the~     Intensive Care Unit (12). This study will include medical and post-surgical patients who~     develop an infection where Avycaz can be utilized. Since these patients will have variable PK~     parameters, the investigators will also analyze (time-kill) these serum concentrations (ex~     vivo) against relevant clinical isolates (e.g. GNR with ESBL or KPC) from the ICU to~     determine microbiologic activity of Avycaz in critically ill patients with variable~     characteristics. Monte-Carlo simulations will also be conducted against clinical ICU isolates~     (JMI labs) to help determine appropriate dosing schedules based upon these PK parameters.~   "
56846|NCT02822937|"~     This is a study in adults to assess the sensitivity of Project: EVO Monitor cognitive~     measurements to two short-acting cognitively active pharmacological agents. The participants~     will receive a placebo, and two pharmacological agents in a randomized order for three~     in-clinic study days. During each study day in the clinic, the participants will use Project:~     EVO Monitor and another cognitive task through the day.~   "
56847|NCT02822924|"~     The objective is to evaluate the clinical effectiveness and safety of PAE in treating~     patients with BPH.~   "
56848|NCT02822911|"~     Alcohol misuse affects 5 million people in France. Even though the elderly are also concerned~     by this pathology, there is not much information about chronic alcohol misuse of this~     population in particular.~      Biological markers like gamma-glutamyltranspeptidase (GGT), mean corpuscular volume (MCV) and~     carbohydrate deficient transferrin (CDT) are usually used to detect alcohol abuse. As a~     biological marker of alcohol misuse, the specificity of the CDT is known to be superior to~     the GGT as well.~      However, when it comes to the elderly, alcoholism diagnosis tools are based on research of~     younger populations.~      This study aims to evaluate the benefit of the CDT to detect chronic alcohol use in the~     elderly.~   "
56849|NCT02822898|"~     The prescription of intravenous maintenance solutions - although widespread - lacks important~     data on the optimal sodium and potassium content, which has given rise to an important debate~     in the scientific literature. Our study compares two different infusion fluids in 12 healthy~     adult volunteers without renal failure in a single-blind randomized crossover design over two~     48 hour periods during which subjects are not allowed to eat or drink. Fluid 1 is a premixed~     solution containing 54 mmol/L of sodium and 26 mmol/L of potassium; fluid 2 is sodium~     chloride 0.9% in glucose 5% with 40 mmol/L of potassium. Both solutions are administered at~     25 mL/kg of ideal body weight, as recommended by current guidelines (NICE 174) and both~     solutions are widely used in daily clinical practice. The primary hypothesis is that isotonic~     maintenance solutions lead to more fluid retention than hypotonic fluids. Metabolism of both~     solutions is assessed by sequential analysis of urine and serum, clinical parameters and~     bioelectrical impedance analysis.~   "
56850|NCT02822885|"~     This study was to investigate the diagnostic value of ultrasonography and blood flow~     measurements in uterine arteries and spiral arteries by transvaginal color Doppler~     ultrasonography in the detection of the endometrial pathology in women with postmenopausal~     bleeding.~   "
56851|NCT02822872|"~     Infertile couples who come for evaluation and treatment in IVF unit could be under~     psychological stress. Many authors in the past suggested that stress itself is one of the~     factors that directly influence fecundability rate. In couples treated in IVF unit, the~     investigators aim to measure chronic stress by measuring hair cortisol level (as a marker for~     chronic cortisol release) and by filling different questionnaires.~   "
56852|NCT02822859|"~     The study will assess three different nebulizers for use in methacholine challenge testing in~     order to determine if the Aeroneb Solo would make a suitable replacement for the long-used~     and now obsolete Wright and Bennett-Twin nebulizers. Results from each device will be~     compared to evaluate whether current guidelines for the methacholine challenge should be~     updated for superior standardization.~   "
56853|NCT02822846|"~     The purpose of this study is to evaluate the diagnostic qualities of lung ultrasonography to~     monitor the position of the intubation probe.~      The primary assessment criterion is of study the position of the intubation probe with two~     examinations carried out independently :~        -  sonography~        -  chest radiography~      A correct position of the intubation probe will be considered if there is :~        -  Highlighting of the extremity of the intubation probe in endo tracheal~        -  Highlighting bilateral lung sliding~   "
56854|NCT02822833|"~     Endometrial cancer is the most common gynecologic malignancy in developed countries and the~     second one in developing countries following cervical cancer. The primary treatment for~     endometrial cancer involves total hysterectomy and bilateral salpingo-oophorectomy, with~     adjuvant radiotherapy and/or chemotherapy reserved for patients with advanced disease or who~     have risk factors for relapse. The tumor is confined to the uterus in 85% of endometrial~     cancers. Hence, it's controversial to perform systematic lymphadenectomy to all patients. The~     primary purpose of the present study is the to investigate the feasibility of sentinel lymph~     node determination in endometrial cancer patients operated via conventional laparoscopy. To~     determine sentinel lymph nodes cervical indocyanine green will be injected prior to the~     surgery. During the surgery using fluorescent imaging systems sentinel lymph nodes will be~     removed and examined by frozen section. Afterwards, systematic pelvic lymphadenectomy will be~     performed. In case of type II endometrial cancer, grade 3, metastatic sentinel lymph nodes or~     macroscopically enlarged paraaortic lymph nodes, paraaortic lymphadenectomy will also be~     performed. The secondary purpose of the study is to compare the conventional laparoscopy in~     sentinel lymph node mapping of endometrial cancer patients.~   "
56855|NCT02822820|"~     This single-institution prospective randomized clinical trial will be performed at the~     Gynecologic Oncology clinic of Ankara University. Patients with endometrial cancer and cervix~     cancer who will be operated for staging via laparoscopic approach will be included in the~     study. The included patients will be randomized to two groups before surgery. During the~     operation of first group instruments with advanced bipolar energy will be used during~     lymphadenectomy and hysterectomy and salpingo-oophorectomy. In the second group the operation~     will be performed by conventional bipolar energy forceps. The outcome parameters to be~     measured are intra-operative bleeding, duration of operation, intraoperative complications,~     postoperative pain score, postoperative complications, postoperative duration of~     hospitalization, late complications such as lymphocele formation and costs.~   "
56897|NCT02822274|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
56856|NCT02822807|"~     The IHU Mediterranean infection is national reference centre for Q fever. Coxiella burnetii~     is the bacteria responsible of this infection. The bacterium Coxiella burnetii infection is~     associated with secretion by the body both many antibodies against the bacteria but also~     against certain cells of the body (autoantibodies). These autoantibodies may have no effect~     or be associated with specific symptoms. Anti-Phospholipid antibodies are especially~     prevalent in the Q fever. Apart from this infection, they are associated with~     thrombocytopenia, obstetric complications, thrombosis and heart valve damage. These~     conditions have also been described as complications during Q fever. In a retrospective~     preliminary work on Q fever, we have shown that the presence of high levels of IgG~     anti-cardiolipin was associated with the presence of valvular and the evolution to~     endocarditis. Such associations have a therapeutic involvement and must therefore be~     confirmed. Indeed, if these associations were confirmed, a trans-esophageal ultrasound could~     be systematically proposed to patients with valvular disease of trans-thoracique ultrasound~     but IgG anticardiolipin high levels. Other special attention could be given to patients with~     high autoantibodies.~   "
56857|NCT02822794|"~     The primary objective of this study is to evaluate the antiviral efficacy, safety, and~     tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC)~     and ribavirin (RBV) in participants with chronic hepatitis C virus (HCV) who have previously~     failed a direct-acting antiviral (DAA)-containing regimen.~   "
56858|NCT02822781|"~     Chronic rhinosinusitis (CRS) is a debilitating disease that remains (smell, nasal patency,~     flow) because currently treatment protocols available to us are with a limited efficacy. The~     assessment of the response to surgical treatment protocols and monitoring the become of~     patients treated with only drugs should allow investigators to identify the predictive~     patient's profile for the response. With this prospective data, this study would allow~     investigators to make a classification of Chronic rhinosinusitis.~   "
56859|NCT02822768|"~     The goal of this study is to examine patients undergoing incision and drainage of cutaneous~     abscesses to determine if routine packing of the abscess cavity affects the need for further~     interventions such as repeat incision and drainage, antibiotic administration or hospital~     admission.~   "
56860|NCT02822755|"~     The purpose of this study is to determine the effectiveness of an individualized video~     recording in improving adherence in home exercise programs for orthopaedic physical therapy~     patients.~      Specific aims:~      1. Evaluate whether individualized video recordings improve adherence with home exercise~     programs (HEP) as compared with conventional printed instructions measured by a self-report~     exercise log. (1-tail analysis)~   "
56861|NCT02822742|"~     The purposes of this study are to investigate the effect of intraocular pressure lowering~     efficacy and safety of DE-117 ophthalmic solution in subjects with primary open-angle~     glaucoma or ocular hypertension who are non-/low-responders to latanoprost ophthalmic~     solution.~   "
56862|NCT02822729|"~     The purposes of this study are to evaluate the long-term safety and intraocular~     pressure-lowering efficacy of DE-117 ophthalmic solution monotherapy and concomitant use of~     DE-117 ophthalmic solution with timolol ophthalmic solution 0.5% in patients with open angle~     glaucoma or ocular hypertension.~   "
56863|NCT02822716|"~     The objectives of this study are to study the safety and effect of IRE as a treatment for~     inoperable hepatic and pancreatic malignancy.~   "
56864|NCT02822703|"~     Tobacco use is one of the most significant cancer control and public health challenges in the~     US today. Half of all smokers in the US will attempt to quit tobacco each year, but fully 95%~     of those who attempt to quit will reverse this decision within 12 months and choose the~     transient, albeit immediately rewarding activity of smoking at the cost of much larger~     long-term rewards such as future health and long life. This project seeks to improve~     scientific knowledge of these decision-making processes and potentially improve the treatment~     of tobacco dependence by examining the feasibility of using a brain stimulation technique,~     repetitive Transcranial Magnetic Stimulation or rTMS to improve the efficacy of an existing~     evidence-based relapse prevention intervention. rTMS is an FDA-cleared treatment for~     medication resistant depression and is being examined as a treatment for a variety of other~     disorders. This study will utilize an intensity and duration of rTMS that is well within the~     safety parameters and similar in location and intensity to that used in previous studies with~     smokers to reduce cigarette consumption.~   "
56865|NCT02822690|"~     The aim of this study is to get insight in the quality of life at the end of life and quality~     of dying for patients died at the hospital in the department Groningen (the Netherlands).~      The primary endpoint is the quality of life at the end of life and the secondary endpoint is~     the quality of dying. Both according a numerical rating scale.~      An explorative analysis will be done for differences for the hospitals in Groningen, effect~     of using the Liverpool care Pathway for the dying, effect of using consultation by the~     palliative consultation team, effect of using the Hospice@UMCG intervention, correlation with~     the quality of life at the end of life and quality of dying according to nurses and doctors.~   "
56866|NCT02822677|"~     The investigators will conduct a cross-sectional study to discovery the distribution of IBS~     subtypes who would like to seek TCM treatment and their TCM patterns. At the same time, the~     investigators will also collect the serum, urine and stool samples of the participants to~     explore the host-gut microbiota metabolic interactions associated with IBS subtypes.~   "
56867|NCT02822664|"~     The main objective is to identify cerebral correlated of pedophilia using neuroimaging~     techniques.~   "
56868|NCT02822651|"~     Vitamin D has effects on many tissues, and hypovitaminosis D is frequent. In a French survey~     conducted among 1587 adults, vitamin D insufficiency (<30ng/ml) has been reported in 80% of~     subjects, including 43% with moderate deficiency (<20ng/ml) and 5% with severe deficiency~     (<10ng/ml).~      Because of the possible consequences of hypovitaminosis D (osteomalacia in adults…), the~     number of vitamin D determination has increased ten-fold since 2005 in France, reaching 4.5~     million € in 2011, and with it the costs for health insurance. However, there is currently no~     consensus on the strategy for detection, diagnosis and treatment of hypovitaminosis D.~      We propose to develop a predictive clinical score of hypovitaminosis D based on the accurate~     assessment of solar exposure, vitamin D intakes and hypovitaminosis D risk factors collected~     through a self-administered questionnaire.~   "
56898|NCT02822261|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
56899|NCT02822248|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
56869|NCT02822638|"~     Ischemic heart disease is the leading cause of mortality in industrialized countries. ST~     elevated acute myocardial infarction is one of its most frequent and deadly manifestation. In~     the last 20 years, STEMI mortality has been reduced by 50% with the advent of timely~     reperfusion (primary percutaneous intervention) and significant progression in pharmacologic~     intervention.~      However, death and heart failure incidence after STEMI remain elevated: up to 20% at one~     year.~      Also, therapeutic management following international guidelines is standardized toward a~     one-size fits all therapeutic management.~      In order to continue improving myocardial infarction outcomes, there is a need to better~     understand and individualize therapeutic targets such myocardial reperfusion injury, post~     reperfusion inflammation, adverse left ventricular (LV) remodeling ….~      This knowledge will allow us to propose new therapeutic strategies and in the long run strive~     towards personalized medicine.~      The aim objective of this cohort of STEMI patients is to identify new biological markers of~     injury and prognosis.~   "
56870|NCT02822625|"~     QUTENZA® is a skin patch with a high concentration of capsaicin (8%) which is the component~     responsible for spicy peppers. QUTENZA® is indicated for the treatment of peripheral~     neuropathic pain in non-diabetic adults either alone or in combination with other analgesics.~     Acute pain experienced during and after the procedure can be relieved by local cooling~     methods and oral analgesics but the pain remains intense. The hypothesis is that hypnosis via~     a standardized hypnotic message would increase the local tolerance of the treatment when~     applying the patch QUTENZA®. To date, there are no studies that can confirm or refute this~     hypothesis.~   "
56871|NCT02822612|"~     Ophthalmology is among the most technology driven of all medical specialties, with advanced~     medical imaging devices - and specialised computer software - increasingly adopted for~     routine clinical use. While many such devices are capable of completing specific tasks, lack~     of usability prevents their widespread adoption (i.e., such devices are not easy to learn~     and remember, or are not efficient or subjectively pleasing to use). Moreover, devices that~     are difficult to use expose patients to clinical risk as a result of human error during~     usage.~      With the introduction of a new medical technology, it is essential, therefore, to have a deep~     understanding of patients, what they need, what they value, their abilities, and also their~     limitations.~      Human factor and usability testing, also known as human factor engineering, deals with the~     formal study of people's interaction with their environment (in this case, the binocular OCT~     device). Structured, patient-centred, usability testing is essential to the design, clinical~     validation, regulatory approval, and widespread implementation, of all new medical devices.~     This is particularly the case for a putative binocular OCT system - a device intended for~     automated use in visually impaired, often elderly, populations. Although the binocular OCT is~     already at an advanced stage of hardware development, the EASE study will facilitate an~     iterative process of operating software and workflow modifications to optimize the device for~     use in these populations.~   "
56872|NCT02822599|"~     The goal of the study is to determine whether the use of Human Fibrinogen Concentrate~     (RiaSTAP) will decrease blood loss and the need for component blood therapy in neonates and~     infants undergoing cardiopulmonary bypass.~   "
56873|NCT02822586|"~     The purpose of this study is to evaluate the cutaneous toxicity and treatment response~     associated with administering concurrent TSEB and brentuximab vedotin in patients with~     mycosis fungoides or Sézary Syndrome.~   "
56874|NCT02822573|"~     This study is to compare the safety and effects of donepezil (Aricept) or if it decreases~     memory loss after receiving chemotherapy for breast cancer.~   "
56875|NCT02822560|"~     The present clinical trial is performed in the field of vascular surgery. The aim of the~     study is the economical and clinical comparison of two different access ways to the femoral~     artery with intention of endovascular repair of aortic aneurysm. The usual access is a~     surgical cutdown to the femoral artery and is compared to a percutaneous access which is~     closed via a suture mediated device (Perclose ProGlide, Abbott).~   "
56876|NCT02822547|"~     Patients will receive Peginterferon alfa-2a according to the standard medical practice but~     the observation period is 12 weeks~   "
56877|NCT02822534|"~     SP2086 is a novel inhibitor of Dipeptide base peptidase 4, allows an insulin-independent~     approach to improve type 2 diabetes hyperglycemia. In this single-dose and multiple-dose~     study the investigators evaluated the safety, tolerability and PK/PD profiles of SP2086 in~     Type 2 Diabetes Patients .~   "
56878|NCT02822521|"~     The overall objective of this proposal is to implement a smartphone application (app) +~     population management system to monitor rheumatoid arthritis (RA) disease activity between~     scheduled physician office visits. The population management system includes: 1) a web-based~     dashboard that consolidates incoming patient-reported data using pre-programmed algorithms to~     identify increases in disease activity, and 2) the population manager, a trained individual~     who monitors the web-based dashboard and connects patients with their HCPs. The investigators~     central hypothesis is that the combined smartphone app + population management system will~     improve patient satisfaction and management of RA disease activity.~   "
56879|NCT02822508|"~     The objective of this study is to evaluate multiple doses of BLI801 Laxative for safety and~     efficacy versus placebo in adults experiencing non-idiopathic constipation.~   "
56880|NCT02822495|"~     The primary objective of this protocol is to provide access to tabelecleucel to patients with~     Epstein-Barr virus-positive post-transplant lymphoproliferative disorder (EBV+ PTLD), EBV+~     primary immunodeficiency lymphoproliferative disease (PID LPD), EBV+ acquired~     immunodeficiency (AID) LPD, and EBV viremia for whom there are no other approved therapeutic~     options, and who are not eligible to enroll in clinical studies designed to support the~     development and registration of tabelecleucel.~   "
56881|NCT02822482|"~     The study consists of two distinct and sequential parts:~        -  A Phase Ib aimed at determining the MTD (Maximum Tolerated Dose) of the combination~          (copanlisib/cetuximab) and the RP2D~        -  A Phase II aimed at evaluating the efficacy of the combination at the RP2D (Recommended~          Phase 2 Dose)~      All patients will be treated with the Copanlisib, a selective PI3KCA inhibitor, in~     association with Cetuximab.~   "
56893|NCT02822326|"~     The purpose of this study is to evaluate the safety and efficacy of chimeric antigen receptor~     19 (CD19-CAR-T2 Cells) infusions in patients with chemotherapy resistant or refractory CD19+~     acute Leukemia.~   "
56894|NCT02822313|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
56882|NCT02822469|"~     Background: Different therapeutic approaches have been proposed for the treatment of TMD.~     Myofascial and joint techniques, exercises, intraoral devices, thermal, electro and~     phototherapy applications, are among the most common. The combination of local treatments and~     adjacent structures such as the cervical region have also been studied in this area. It is~     believed that the anatomic proximity, neuronal interconnections and convergent afferents from~     the trigeminal and cervical areas can lead the understanding of the relationship of these~     structures. In order to assess the effects of these different forms of treatment studies have~     used different resources such as diagnostic imaging and biological signals, in order to~     complement the clinical diagnosis. Infrared thermography has been one of the resource~     assessment in the literature and it is interesting and stands out from other methods because~     it is functional, non-invasive and inexpensive.~      Purpose: To evaluate the thermograms concerning the masseter and anterior temporal muscles,~     severity, pain, range of mandibular motion and neck disability in TMD patients, before and~     after physical therapy applied to the cervical and thoracic regions.~      Methods: This is a randomized, placebo-controlled study, designed to evaluate the effects of~     indirect treatment on the thermography of the masticatory muscles, severity, pain, range of~     motion and neck disability in individuals with TMD. These will be randomized and allocated~     into two groups: GA (intervention) and GB (placebo) and assessed as: Diagnostic Criteria for~     Temporomandibular Research Disorders (RDC/TMD), Fonseca´s Anamnesic Index (FAI),~     Thermography, EVA, IDD-CF, Pachymetry and Neck Disability Index (NDI).~      Statistical analysis: The temperature of the orofacial region, acquired through thermography~     is considered the primary endpoint and as a secondary endpoint will be the evaluation of the~     severity according to FAI, pain by VAS and IDD-CF, the range of mandibular motion by~     pachymetry and neck disability by NDI.~      Statistical analysis: The normality of the data will be verified using the Kolmogorov-Smirnov~     test, which will be expressed as mean and standard deviation and/or median and interquartile~     range. Repeated measures analysis of variance of two factors, post hoc Bonferroni will be~     used for inter and intra-group comparisons. The significance level of p≤0.05 is set.~   "
56883|NCT02822456|"~     The aim of this study is to test the clinical effectiveness of IOE tube using individually~     customized 3-dimentional printed guiding tube as an alternative to Levin tube feeding when~     unconscious patients have no choice but tube feeding.~   "
56884|NCT02822443|"~     The primary purpose of this study is to compare the efficacy of two treatment-as-usual (TAU)~     conditions: TAU with integration of emotion focused components (EFT) and TAU with focus on~     self-regulation (SR). Especially the long-term efficacy is evaluated with a focus on~     differential effects. Moreover, the mechanisms of change of both conditions are investigated.~   "
56885|NCT02822430|"~     For several decades, authors are interested in the existence and meaning of painful symptoms~     in a population of psychiatric inpatients. But, to date, studies specifically focused on the~     impact of pain in patient populations in psychiatric hospitals are few. More recently, a~     review of the literature highlights the difficulties of evaluation of pain in populations of~     psychiatric patients but also the complex interrelationships between painful symptoms and~     psychiatric diseases. The first national survey conducted among 172 health which evaluate~     pain and its management in the field of psychiatry concluded on the need to develop research~     in this area.~   "
56886|NCT02822417|"~     To evaluate the effect of clinical factors on the recovery time of postoperative anesthesia~     and the effect of genetic variation in gDNA on the recovery time of postoperative anesthesia.~   "
56887|NCT02822404|"~     Cisplatin and ifosfamide are commonly used drugs in chemotherapy. They are known to involve~     renal toxic threats in children given their immature kidney. This toxicity is increased~     especially after nephrectomy and/or concomitant radiotherapy. In pediatric oncology, the~     available evaluation methods of the renal function could be very restrictive to perform on~     children. In this study, the investigators intend to test the use of the cystatin C as an~     effective and reliable biological marker of renal toxicity in children treated with cisplatin~     and / or ifosfamide.~   "
56888|NCT02822391|"~     Orofacial impairment following stroke frequently involves a reduced chewing performance and~     dysphagia. This study investigated the sensitivity of oral tissues following stroke and its~     potential impact on chewing efficiency.~      The following two Null-hypotheses (H0) were tested:~      i. Post-stroke patients do not show a reduced intra-oral sensitivity compared to a healthy~     controls.~      ii. Intra-oral sensitivity is not correlated to chewing efficiency.~   "
56889|NCT02822378|"~     Postmenopausal women often seek non-pharmacologic interventions for the protection of bone~     health. Previous research in humans and rodents has indicated that dietary dried plum~     consumption may be beneficial for bone health, especially in postmenopausal women. However,~     it is unknown in what quantity dried plums need to be consumed to be of benefit and through~     what mechanisms dried plums act to impact bone health. Therefore, the purpose of this study~     is to evaluate the impact of 52 weeks of dried plums consumption in varying quantities on~     bone mineral density (BMD), bone geometry, and estimated bone strength in postmenopausal~     women. The investigators also seek to evaluate the mechanisms underlying the effects of dried~     plums as a dietary supplement by assessing polyphenols and the bioavailable conjugated~     metabolites in the urine of postmenopausal women taking different doses of dietary dried~     plums. The investigators aim to further investigate the mechanisms of dried plum action on~     bone by measuring markers of bone metabolism in response to dried plum consumption.~   "
56890|NCT02822365|"~     This pilot study tests the pocket phantom tool in improving the accuracy of quantitative~     positron emission tomography/computed tomography (PET/CT) imaging of patients with solid~     tumors. The pocket phantom tool may help test the accuracy of the PET/CT scanner and indicate~     whether adjustments need to be made to get consistent information.~   "
56891|NCT02822352|"~     Colitis is inflammation of the large bowel and it is often caused by conditions known as~     ulcerative colitis and Crohn's disease. In these conditions, the body has an exaggerated~     inflammatory response against the bowel - the body attacks the bowel. Patients who have had~     colitis affecting most of the large bowel for more than 8 years are at increased risk of~     cancer of the large bowel. In view of this, many national gastroenterology organisations have~     recommended that such patients have regular colonoscopies to detect pre-cancerous areas and~     even early cancer in the large bowel. Early detection of such areas, will lead to early~     treatment thereby reducing the risk of developing significant large bowel cancer. These~     regular colonoscopies are known as surveillance colonoscopies.~      Official international guidelines for surveillance in patients with ulcerative and Crohn's~     colitis advise to take 4 random samples of large bowel tissue (biopsies) every 10 centimeters~     and of any suspicious areas. Recent studies have shown that spraying dye such as indigo~     carmine (a type of food dye) helps highlight abnormal areas that could harbor pre-cancerous~     cells. This technique is time-consuming, and tedious. There are no set standards of what is~     considered a satisfactorily completed dye spray colonoscopy. The uptake of this technique in~     the UK has not been uniform. Therefore virtual chromoendoscopy has been studied as an~     alternative method to improve the detection of pre-cancerous tissue in patients with~     longstanding colitis.~   "
56892|NCT02822339|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
56901|NCT02822222|"~     The purpose of this study is to evaluate the safety of RMJH-111b, including how well it is~     tolerated, and the effect of RMJH-111b on blood pressure in subjects with hypertension. The~     study will also measure the amount of magnesium in the blood and urine before and after~     RMJH-111b administration to evaluate what the body does to RMJH-111b (pharmacokinetics).~   "
56902|NCT02822209|"~     The prognosis of patients with lung cancer is related to the stage of the diagnosis : 73% of~     one-year-survival rate at stage IA and only 13% one-year-survival rate at stage IV.~     Controlling the timelines in a care program seems crucial to improve prognosis of lung~     cancer.~      The project aims to evaluate the impact of a coordinating nurse (CN) in a personalized care~     program for patients of thoracic oncology.~   "
56903|NCT02822196|"~     HYPOTHESIS~      Serratus Anterior Muscle Plane Block (SPB) is as effective as thoracic paravertebral block~     (PVB) for acute pain control after unilateral mastectomies.~      SPECIFIC AIMS~      Primary aim: To evaluate the efficacy of SPB block vs thoracic PVB for acute pain control in~     patients undergoing unilateral mastectomy~      Secondary aim To compare the onset and duration of block and dermatomes blocked in both~     groups To compare the need of post-operative rescue analgesia in both groups. To compare the~     development of chronic incisional pain in both groups Functional outcome with respect to~     daily activities.~   "
56904|NCT02822183|"~     This online survey presents capnography waveforms and asks the survey participants to give~     feedback about their interpretation of the patient status, both in the form of a score and a~     set of text to describe their interpretation.~   "
56905|NCT02822170|"~     The purpose of this small pilot study is to refine a combined intervention of IV amino acids~     and cycle ergometry in critically ill patients, and to gather preliminary data, before~     proceeding with a larger multi-center RCT. A total of 10 patients will receive the combined~     intervention.~   "
56906|NCT02822157|"~     This is a randomized, open-label, two-arm study in patients with relapsed epithelial ovarian~     tumors. Patients will be randomized in a 1:1 ratio to receive olaparib or standard~     chemotherapy with the possibility of crossover at the time of progression.~   "
56907|NCT02822144|"~     In France, the annual incidence rate of acute ischaemic stroke is around 150 000 patients, 65~     % of whom keep long-term disability. Several multicentric randomized controlled trials have~     shown the benefit of a mechanical thrombectomy in the acute phase of ischaemic stroke on~     functional disability, compared to a medical treatment alone (thrombolysis).~      The timeliness of revascularisation is an essential factor of good prognosis. This~     intra-arterial treatment, associated with thrombolysis if applicable, is the reference~     treatment of large-vessel occlusion. The stillness of the patient is required to control the~     safety of the recanalization. Currently, either a general anesthesia or a sedation can be~     performed.~      Several studies have shown a trend to superiority of the sedation but none was conducted with~     a high level of proof methodology.~      The aim of our multicentric randomized controlled trial is to compare sedation and general~     anesthesia during intra-arterial thrombectomy for an acute ischaemic stroke in the anterior~     cerebral circulation. The main outcome will be the efficacy on the functional neurological~     prognosis at 3 months.~   "
56908|NCT02822131|"~     High dietary phosphate intake in the general population is associated with a higher risk for~     developing kidney disease and cardiovascular disease with an increased overall mortality.~     Whereas the effects of high phosphate intake on general health become clearer, almost nothing~     is known about underlying mechanisms. More recently, the investigators and others found in~     animal models that FGF23 stimulates the renal NaCl cotransporter NCC, the target of thiazide~     diuretics, and that increased NCC activity may increase blood pressure. The investigators~     could also show that increasing dietary phosphate intake in mice, increases FGF23 and NCC~     activity within 3 days. Thus, the objective of this single-centre observational cross-over~     study including 20-45 year old healthy male probands is to elucidate the role of dietary~     phosphate on blood pressure regulation and renal handling of sodium chloride in healthy~     subjects. Further the impact of dietary phosphate intake on the regulation of phosphaturic~     hormones and other factors regulation blood pressure will be investigated. In addition, the~     investigators will examine whether phosphate intake modulates gut microbiome composition. The~     primary outcome in this study is the change in blood pressure in healthy subjects on~     low-phosphate diet compared to healthy subjects on high-phosphate diet. In addition, to~     assess changes in NCC activity as the main mechanism of phosphate-sensitive blood pressure~     regulation, renal sodium chloride excretion after administration of hydrochlorothiazide will~     be measured. The secondary outcomes of this study are: changes in renal phosphate, calcium~     and potassium excretion, changes in phosphate regulation hormones such as 25-OH-Vit. D,~     1,25-(OH)2-Vit. D, PTH, FGF23, dopamine in plasma and urine, changes in plasma and urinary~     aldosterone levels, changes in sodium/chloride-cotransporter NCC and NaPi-IIa assessed from~     urinary exosomes, and changes in stool phosphate excretion and gut microbiome composition.~   "
56909|NCT02822118|"~     To evaluate the efficacy and safety of TCM decoction Chang'an I Recipe in the treatment of~     IBS-D. A multicenter, randomized, double-blind, placebo-controlled clinical trial was~     designed. Patients were applied for central random number and were given corresponding~     treatment according to inclusion sequences.The treatment group was administered the Chang'an~     I Recipe, 150ml/bag, 3 times/day; while the control group was administered the placebo,~     150ml/bag, 3 times/day. Both courses of treatment were 8 weeks.~   "
56910|NCT02822105|"~     The purpose is of this study is to assess the safety and tolerability of three dose levels of~     H3N2 M2SR influenza vaccine versus placebo delivered intranasally to healthy adult subjects.~   "
56911|NCT02822092|"~     This is an observational neuroimaging treatment study. This study involves examining the~     neural circuitry of controlled treatment of patients presenting with a first-episode of~     psychosis with risperidone. Patients who present for treatment of a first psychotic episode~     with a schizophrenia spectrum diagnosis and who are eligible to undergo treatment with~     risperidone will be offered participation in the study. Clinical ratings, neuropsychological~     testing, neuroimaging and EEG will be conducted at baseline. Additionally, subjects will~     undergo the same assessments at week 12 to determine treatment-related biomarkers. Clinical~     ratings, including neurocognitive testing, will be conducted by blinded raters at study~     visits during treatment. Healthy controls (N=50) will also be recruited and scanned twice~     (12-week interval) to control for effects of time and practice.~   "
56912|NCT02822066|"~     The pupose of this study is to evaluate the safety and efficacy of irreversible~     electroporation (IRE) for refractory neoplasms in liver and pancreas, the investigators used~     preoperative and postoperative US/CEUS/CT/MRI to assess lesions, and laboratory tests~     including the tumor markers to evaluate the general condition of patients. Intraoperative~     US/CEUS/CT would be applied to monitor ablation lesions.~   "
56913|NCT02822053|"~     The purpose of this study is to evaluate the safety and efficacy of ultrasonography (US)~     -guided laser ablation liver, kidney, pancreas, lung and retroperitoneal tumors, the~     investigators used preoperative and postoperative US/CEUS/CT/MRI to assess lesions, and~     laboratory tests including the tumor markers to evaluate the general condition of patients.~     Intraoperative US/CEUS/CT would be applied to monitor ablation lesions.~   "
56916|NCT02822014|"~     Objective Prospectively describe the kinetics of 18F-FDG uptake of extrapulmonary TB after~     two months and at the end of TB treatment in HIV patients. Evaluate 18F-FDG-PET/CT as a TB~     treatment response monitoring tool.~      Design The investigators performed baseline FDG-PET/CT, another FDG-PET/CT after 2 months of~     TB treatment and a PET/CT at the end of treatment in 18 HIV/TB patients. The investigators~     correlated evolution of FDG uptake with clinical evolution of patients.~   "
56917|NCT02822001|"~     The Primary objective of this study is to determine whether patients who receive sugammadex~     immediately after tracheal extubation will exhibit a decrease in the incidence of~     postoperative residual paralysis and an associated decrease in the incidence of postoperative~     respiratory depression (which can precede critical respiratory events, CRE).~      The Secondary objectives are to: a) determine whether patients receiving sugammadex will have~     a normal TOF ratio (>0.90) indicative of full neuromuscular recovery in the PACU; and b) to~     improve patient safety by documenting whether postoperative respiratory depression (decreased~     MV below 80% and 40% of predicted MV as assessed by a Respiratory Volume Monitor) is due to~     opioid administration vs. postoperative residual neuromuscular block (by comparing~     postoperative VAS scores and total opioid administered).~   "
56918|NCT02821988|"~     It is well established that obese women are at an increased risk of stillbirth compared to~     non obese women. This has led many physicians to begin antenatal testing in obese women in~     the third trimester through either nonstress tests or biophysical profiles. However, there is~     little evidence that antenatal testing improves fetal outcomes in obese women. The aim of~     this study is to determine if antenatal testing improves outcomes in obese women and to~     determine the optimal mode of testing (either nonstress tests or biophysical profiles).~   "
56919|NCT02821975|"~     Cognitive impairment plays an important role in functional recovery and leads to long-term~     sickness absence. Therefore there is a need of a treatment specifically improving cognitive~     functions. In this pilot study the investigators aim to evaluate the feasibility of using~     cognitive computer training in patients with unipolar depression to enhance cognitive~     performance. Further the investigators investigate whether this intervention shortens sick~     leave.~   "
56920|NCT02821962|"~     Exercise-based cardiac rehabilitation (CR) has been shown to consistently reduce the rates of~     total and cardiovascular-related mortality and morbidity. Sedentary behaviours have been~     shown to be high in patients with cardiovascular disease, but it is not yet known if current~     CR programming results in significant reductions in these behaviours, or whether a targeted~     component is warranted. It is also unclear if self-reported sedentary time measures can~     provide valid and reliable information for monitoring these behaviours in a CR setting, or~     whether more objective measures are needed. The purpose of this study is to assess the~     feasibility and usability of the activPAL3 devices for measuring sedentary time in a CR~     setting, describe changes in sedentary time that occur with standard CR and assess whether~     the addition of prompting cues from a device can result in further declines in sedentary~     behaviour and improvements in clinical outcomes, health related quality of life, symptoms of~     anxiety and depression, aortic stiffness, and aerobic capacity.~   "
56921|NCT02821949|"~     Treatment of a stage IV NSCLC is based on chemotherapy and requires before each session to~     check clinically, biologically and radiologically absence of infection. This biological~     evaluation is based on the CRP rate. Lots of infections may occur in this situation and could~     reduce by three the patient's life duration. However it is very important to make as early as~     possible a correct diagnosis of infection. CRP rate is classically higher for those patients~     even without any infection. In comparison with CRP, Procalcitonin (PCT) is well-known for its~     better sensibility and specificity for the infection diagnosis but has never been study in~     case of active cancer. The aim of this study is to evaluate the Procalcitonin basal rate for~     those patients suffering from NSCLC. It could be a simple and reliable method to use. So the~     investigators decided to include each new patient with NSCLC stage IV coming for his~     first-line chemotherapy without any infection sign, and to realize a Procalcitonin dosage~     before the start of the treatment. This sample will be analyzed at the chemical laboratory~     and the result will not be communicated to the patient physician. A new clinical evaluation~     will be realized either at the hospital or by phone at day 7 to search any sign of infection.~     In absence of infection, patient will be reevaluated at day 14, 21 and 30. In case of~     infection, a new Procalcitonin (and CRP) dosage will be performed.~   "
56922|NCT02821936|"~     The purpose of this study is to evaluate the concordance between Positron E mission~     tomography parametric imaging versus standard PET for the 1 year prognosis of patients with~     NSCLC treated by radiochemotherapy.~      The ancillary study will evaluate the interest of parametric PET imaging during the treatment~     (around 42 Gray) to detect the local relapse of the lesion in order to propose a treatment~     re-planification or intensification (not realized on the present study).~   "
56923|NCT02821923|"~     Sugar alcohols such as xylitol and erythritol are increasingly popular as sugar substitutes~     in the food industry and are also recommended to diabetic patients. Both substances are~     already in use in the food industry and are freely available. Since the 1970s, beneficial~     effects on oral health could be demonstrated as oral bacteria were influenced positively. A~     pilot study recently undertaken in the US (Flint N, 2014) has shown that diabetics profit~     from a daily intake of erythritol, as this natural sweetener enhances the elasticity of the~     blood vessels. In this trial, investigators aim to examine whether this effect can be found~     in a non-diabetic but obese cohort, and whether also xylitol improves vascular function.~   "
56924|NCT02821910|"~     The purpose of this trial is to demonstrate the relative bioavailability of 2 newly developed~     fixed dose combinations (FDC) tablets containing empagliflozin, linagliptin & metformin~     extended release (XR) and the single tablets of empagliflozin, linagliptin and metformin XR~     administered simultaneously.~   "
56925|NCT02821897|"~     Study design 60 patients Monocenter prospective study Randomized in 2 groups 36 months~     Objectives Demonstrate the superiority of target controlled intravenous anesthesia versus~     total anesthesia with the low back paresthesia mapping in at least 95% of patients implanted~     with a multicolumn lead.~   "
56939|NCT02821715|"~     This Phase 2 study is a 3-site, double-blind, randomised, placebo-controlled, 3-way~     cross-over trial, involving 3 treatments with Modafinil 300 mg or the combination drug THN102~     (Modafinil/Flecainide 300 /3 mg, Modafinil/Flecainide 300 /27 mg).~   "
56926|NCT02821884|"~     Transcranial direct current stimulation (tDCS) has been shown not only to improve motor~     function but also increase cortical excitability and neural plasticity. Several studies~     demonstrated that the combination of tDCS and different treatments are more effective than a~     single tDCS alone. However, the effects of combination tDCS and neuromuscular electrical~     stimulation (NMES) on upper extremity motor recovery in patients with stroke have not yet~     been investigated. Taking into consideration the safety and feasibility of new medical~     technology, recruitment of healthy subjects as a pilot study. And then recruit the stroke~     patients to investigate the effects for the combination of tDCS and NMES on upper extremity~     motor recovery in stroke.~   "
56927|NCT02821871|"~     All eligible subjects were randomly assigned to group A and group B sequences, each sequence~     has 12 subjects. The SP2086 were given limosis,then after the meal,then limosis.In the study~     ,the investigators collected the blood samples,urine samples and fecal samples to analyze.~   "
56928|NCT02821858|"~     The purpose of this study is to investigate the pharmacokinetics (PK), safety and~     tolerability following single oral administration of ascending doses of odalasvir (ODV) in~     healthy Japanese participants (Panel 1) and to investigate the PK, safety and tolerability~     following single oral administration of ascending doses of AL-335 in healthy Japanese~     participants (Panel 2; Sequential Design).~   "
56929|NCT02821845|"~     This project will characterize lower extremity eccentric muscle function among individuals~     who have undergone locomotor training after spinal cord injury and will evaluate the effect~     of downhill training at slow speeds - targeted to rehabilitation eccentric function of the~     hip.~   "
56930|NCT02821832|"~     Background:~      Tuberculosis (TB) is a bacterial lung infection. Typical treatment using anti-TB drugs lasts~     about 6 months. Some people with less severe TB might not need to take the drugs that long.~     Researchers think a PET/CT lung scan along with estimating how much TB is in the lungs might~     show who will be cured after only 4 months of treatment.~      Objective:~      To demonstrate that 4 months of treatment is not inferior to 6 months of treatment for people~     with less severe TB.~      Eligibility:~      People 18 65 years old who have TB treatable with standard TB drugs~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Blood and urine tests~      HIV test~      Sputum sample: Participants will be asked to cough sputum into a cup.~      Chest x-ray~      Participants will start TB drugs. They will have visits at weeks 1, 2, 4, 8, 12, and about 6~     more times during the 18-month study. Visits include:~      Sputum samples~      Physical exam~      Blood tests~      PET/CT scans at 2 3 visits: Participants fast for about 6 hours before the scan. Participants~     get FDG, a type of sugar that gives off a small amount of radiation, through an arm vein.~     They lie on a table in a machine that takes pictures of the body.~      Chest x-rays at 1 2 visits~      Participants who we believe are likely to be cured at 4 months will be randomly assigned to~     get either 6 months of treatment or 4 months of treatment.~      Participants may be asked to join a substudy using their sputum samples or additional blood~     tests.~   "
56931|NCT02821819|"~     The purpose of this prospective single-center study is to evaluate the laboratory outcome~     after random start ovarian stimulation in oocytes donors. The study will be performed in~     egg-donors but this type of treatment has the potential to be implemented in general~     infertility population.~   "
56932|NCT02821806|"~     Title: Collection of Peripheral Blood Mononuclear Cells (PBMCs) from Healthy People for the~     Expansion of T Cells for Adoptive Cell Therapy~      Background:~      New therapies are being developed that use a person s own immune system to fight tumors. Some~     of the tumors being studied include cancers caused by viruses. Researchers want to use the~     healthy cells of volunteers to perform research studies. To do this, they are collecting~     lymphocytes through leukapheresis.~      Objectives:~      To collect healthy cells from volunteers for research studies for new cancer therapies.~      Eligibility:~      Healthy people ages 18 and older~      Design:~      Participants will be screened with a standard donor questionnaire. It asks about their health~     and past medical problems. It also asks about risky behaviors that could increase their~     exposure to viruses or bacteria that could be transmitted through a transfusion. Participants~     will give a blood sample to make sure they are able to donate. They will have a physical~     exam. A finger stick test will check their hemoglobin, or red blood cell, level. They might~     give a urine sample.~      Participants will undergo apheresis. For this, a needle is placed in a vein in each of their~     arms. Their blood is taken from one arm. A machine separates the white cells from the red~     cells and plasma by a spinning process. The white cells are removed and directed into a~     plastic bag. The red cells and plasma are returned through the needle in the other arm. The~     entire procedure takes 4 6 hours.~      Participants may donate every 21 days in this protocol if they choose to.~   "
56933|NCT02821793|"~     The main objective of study is to describe the priorities of elderly patients (70 years and~     over) undergoing a first medical treatment for cancer, at initiation of treatment and after 3~     months of treatment. The main criterion is a prioritization of 4 items per patient from a~     list of 8 expectations regarding the objectives of their treatment: treatment efficacy, life~     expectancy, autonomy, daily activities, social activities, heaviness of treatment, toxicity,~     economics.~   "
56940|NCT02821702|"~     This study is the first to investigate the fertility outcome and the influence on ovarian~     reserve after using uterine artery embolization during cesarean delivery.~   "
56941|NCT02821689|"~     Interstitial lung disease (ILD) is a common complication of dermatomyositis (DM) with~     prevalence up to 65%, and is considered to be one of the determining factors of prognosis.~     Clinical amyopathic dermatomyositis (CADM), which is a special phenotype of DM, with~     characteristic cutaneous manifestations but no or only subclinical myopathy. Many studies,~     mainly from Asia, including ours, have demonstrated that these patients with CADM tend to~     develop a rapidly progressive ILD (RPILD) and have a poor response to conventional therapy,~     such as high-dose corticosteroids and immunosuppressants, leading to lethal outcome with a~     6-month survival rate of less than 50%.~      Pirfenidone, a new oral antifibrotic agent, has been approved for the treatment of idiopathic~     pulmonary fibrosis (IPF). Randomized controlled trials of pirfenidone in patients with IPF~     suggested that it could ameliorate pulmonary function decline and improve the~     progression-free survival. Its utility in connective tissue disease (CTD) related ILD has~     been implicated, but no evidence has yet demonstrated its efficacy. Therefore, the~     investigators conduct this study to evaluate the possible therapeutic effects of pirfenidone~     on RPILD associated with CADM.~   "
56934|NCT02821780|"~     Cerebral autosomal dominant arteriopathy with subcortical infarct (CADASIL) is a lethal~     disease caused by a gene mutation that affects arteries in the brain. Symptoms include~     migraines, strokes, memory loss, and dementia. There are no treatments. Researchers want to~     study people who have CADASIL to learn more about it.~      Objectives:~      To learn more about CADASIL by studying people who have it.~      Eligibility:~      People ages 18-100 who were diagnosed with CADASIL in the past 5 years and can make their own~     decisions~      Design:~      Participants will be screened in another NIH protocol.~      Participants will have 3 visits over 2 years. These may include:~        -  Physical exam~        -  Thinking and concentration tests~        -  Blood tests~        -  Skin biopsy: A small skin punch is removed from the arm or leg~        -  Eye exam and eye imaging tests~        -  Fluorescein angiogram: A catheter is placed in an arm vein. Dye is given through the~          catheter and travels~      to the eyes.~        -  EndoPAT: A small clamp on the fingertip measures blood volume.~        -  Cardio-ankle vascular index (CAVI): Artery stiffness is tested with blood pressure cuffs~          on the arms and~      legs. Soft electrodes on the skin measure heart signals.~        -  Brain MRI or MRA: They lie on a table that slides in and out of a tube that takes~          pictures. They may get~      a contrast agent in their vein. It brightens the brain so researchers can see where blood~     flows.~        -  CT scan of the heart: They lie on a table that slides in and out of a machine that takes~          pictures.~        -  They get contrast dye injected through a catheter. They may get a medicine that makes~          their blood~      vessels bigger or slows their heart rate.~   "
56935|NCT02821767|"~     Background:~      The National Eye Institute (NEI) wants to evaluate and provide standard treatment to people~     with eye diseases.~      Objective:~      To examine and treat people with eye diseases and learn more about eye diseases and how they~     are inherited.~      Eligibility:~      People with eye diseases who can give consent or have a guardian who can consent for them~      Design:~      Participants will be screened with an eye exam.~      Participants will have 1 12 visits per year depending on their eye disease for up to 5 years.~     Visits last about 4 hours and could include:~      Medical and family history~      Physical exam~      Eye exam and photography.~      Oculography: They put on contact lenses or goggles. They watch spots on a computer~      screen for 20 30 minutes.~      Electrooculography: Small metal disks are placed on the skin next to both eyes. They look~     left~      and right in the dark and light for about 30 minutes.~      Electroretinography: They sit in the dark with their eyes patched. A small metal disk is~     taped~      to the forehead. After 30 minutes, the patches are removed and contact lenses put in. They~      watch flashing lights.~      Fluorescein angiography: A needle guides a thin plastic tube into an arm vein. A dye is~      injected through the tube and travels up the blood vessels in the eyes. Pictures are taken of~     the~      eyes.~      Immunosuppressive treatment~      Eye cell sample: Samples are obtained from swabbing, pressing paper on, or taking a small~      biopsy sample from the surface of the eye.~      Blood tests~      Skin, tear, urine, saliva, stool, or hair sample~      Exam under anesthesia for some children~      At each visit participants could get medications, eye drops, eye injections, laser~     treatments, or surgery.~   "
56936|NCT02821754|"~     BACKGROUND:~        -  Various tumor ablative procedures and techniques have been shown to result in~          immunogenic cell death and induction of a peripheral immune response. The term ablative~          therapies applies to trans-arterial catheter chemoembolization (TACE), radiofrequency~          ablation (RFA) and cryoablation (CA).~        -  The underlying hypothesis of this study is that the effect of immune checkpoint~          inhibition can be enhanced by TACE, CA and RFA in patients with advanced hepatocellular~          carcinoma (HCC) and biliary tract carcinomas (BTC). We have already demonstrated proof~          of principle as well as safety and feasibility of this approach with anti-CTLA4 therapy.~        -  Based on the concept of PDL1-mediated adaptive resistance and the emerging role of PD1~          therapy in HCC, we would like to evaluate the combination of tremelimumab and durvalumab~          (with ablative therapies) in HCC and BTC.~      Objectives:~      - To preliminarily evaluate the 6-month progression free survival (PFS) of combining~     tremelimumab and durvalumab in patients with advanced HCC (either alone or with cryoablation,~     TACE or RFA) and in patients with advanced biliary tract carcinoma (BTC) (either alone or~     with cryoablation or RFA).~      ELIGIBILITY:~        -  Histologically or cytologically confirmed diagnosis of HCC or biliary tract carcinoma OR~          histopathological confirmation of carcinoma in the setting of clinical and radiological~          characteristics which, together with the pathology, are highly suggestive of a diagnosis~          of HCC (or biliary tract carcinoma).~        -  Childs-Pugh A/B7 cirrhosis only is allowed. If patient does not have cirrhosis, this~          limitation does not apply.~        -  Patients must have disease that is not amenable to potentially curative resection,~          radiofrequency ablation, or liver transplantation.~      DESIGN:~      We will evaluate the combination of tremelimumab and durvalumab (with ablative therapies) in~     cohorts A (HCC; N=40) and B (BTC; N=30). The first N=10 patients in both cohorts will receive~     tremelimumab and durvalumab only (i.e. No interventional radiologic procedures).~        -  A: Advanced HCC, BCLC# Stage B/C~             -  N= 1st 10 pts: No ablative procedure Cryoablation/RFA/TACE##~             -  Tremelimumab 75mg flat dose q28 days for 4 doses; Durvalumab 1500mg flat dose q28~               days until EOS###~             -  40 total: 10 trem+ dur alone; 10 trem+ dur + TACE; 10 trem + dur + RFA; 10 trem +~               dur + cryo~        -  B: Intra/extra-hepatic cholangiocarcinoma~             -  N= 1st 10 pts: No ablative procedure; RFA/ cryoablation~             -  Tremelimumab 75mg flat dose q28 days for 4 doses; Durvalumab 1500mg flat dose q28~               days until EOS###~             -  30 total: 10 trem+ dur alone; 10 trem + dur + RFA; 10 trem~                  -  BCLC = Barcelona clinic liver cancer staging system~                       -  For BCLC stage B patients TACE may be repeated as per standard of care~                            -  EOS = End of study treatment or meeting any of the off-treatment or~                              off study criteria.~   "
56937|NCT02821741|"~     Background:~      The vagus nerve runs from the brain to many organs. Stimulating it can affect the experience~     of pain. The nerve can be stimulated on the surface of the left ear. Researchers want to~     study how this stimulation affects the perception of pain. They also want to study how mood~     affects the experience of pain.~      Objective:~      To study the effects of mood and vagus nerve stimulation on the experience of pain.~      Eligibility:~      Healthy people ages 18 and older who are fluent in English~      Design:~      Participants will be pre-screened with a 15-minute phone call.~      Participants will have three 2-hour visits.~      At the screening visit, participants will be screened with:~      Medical and psychiatric history~      Physical and psychological exams~      Questionnaires about physical and psychiatric health and mood~      Urine tests~      A heat probe on the forearm. The temperature will be increased until it is painful~      but tolerable.~      Participants will have 2 testing sessions within 7 days. Before the testing, they cannot do~     the following:~      Eat, use nicotine, or exercise for at least 2 hours~      Drink alcohol for 24 hours~      Take certain medicines for 3 days~      Testing includes:~      Urine drug screening~      Left ear stimulation: In one session, the vagus nerve will be stimulated. In the other, an~     area~      of the ear away from the vagus nerve will be stimulated. This will be done with mild electric~      shocks that cause a tingling, pricking, or itchy feeling.~      Heat applied to the forearm until it is painful but tolerable~      Completing several forms on a computer or on paper about how they are feeling~      Monitors on the chest and a finger clip to monitor heart, breathing, and blood pressure~   "
56938|NCT02821728|"~     This study evaluates whether a broccoli intervention (≥ 4 weeks) will result in differences~     in tissue sulphate levels in men scheduled for prostate biopsies. Comparisons will be made~     between participants randomised to the broccoli-rich diet and those randomised to the~     non-intervention arm.~   "
56942|NCT02821676|"~     Regional Anesthesia is a procedure in which numbing medication is injected around nerves that~     transmit pain from areas involved in a surgery. The objective is to block the nerves so a~     patient does not feel pain after surgery. Regional nerve blocks offer many advantages over~     traditional anesthetic techniques, including faster recovery time, fewer side effects and a~     dramatic reduction in post-surgical pain.~      The use of regional anesthesia in breast reconstructive surgery, such as the latissimus dorsi~     flap, has led to major improvements in patient care. Today, the most common regional~     anesthetic used in latissimus dorsi flap reconstruction is the intercostal nerve block, where~     numbing medication is injected around the nerves supplying the chest wall.~      While intercostal nerve blocks have been used successfully in breast surgery, they do not~     provide a complete nerve block to the chest wall, as there are some nerves that are~     unaccounted for in the block which can contribute to a patients pain after surgery.~      The mixed pectoral one / serratus plane block (PECI/SPB) block is another regional nerve~     block that has been successfully used by anesthesiologists at The Ottawa Hospital and offers~     a more complete pain blockade than the intercostal nerve block, as it includes more nerves~     that supply the breast. In addition to this, the intercostal nerve block is a so-called~     blind-technique compared to the PECI/SPB block, which is more accurately guided by~     ultrasound. Blind techniques are associated with higher failure rates.~      Both the intercostal nerve block and the PECI/SPB nerve block have been used successfully at~     the Ottawa Hospital. In this study, the investigators propose a prospective, double blinded,~     randomized controlled, head to head comparison of the PECI/SPB and intercostal nerve block to~     determine which block is associated with the best pain blockade and patient satisfaction in~     lattissimus dorsi flap surgery.~   "
56943|NCT02821663|"~     Systemic sclerosis is a systemic connective tissue disease with physical and mental~     disturbances. Based on a pilot study the feasibility and effectiveness of a novel,~     self-developed concept of vocal intervention in Systemic Sclerosis under vocal pedagogical~     guidance and music therapy is assessed.~   "
56944|NCT02821650|"~     The present study documents a randomized controlled study investigating the efficacy of~     improved cookstove on the personal exposure to air pollution and the respiratory health of~     women and children in an Indian slum. The improved cookstove is based on co-creation of a~     low-smoke chulha with local communities in order to support adaption and sustained uptake.~     The study is conducted in a non-notified slum in Bangalore, India. The study design is be a~     1:1 randomised controlled intervention trial, including 250 households. Outcomes include~     change in lung function (FEV1/FVC), incidence of pneumonia, change in personal PM2.5 and CO~     exposure, incidence of respiratory symptoms (cough, phlegm, wheeze and shortness of breath),~     prevalence of other related symptoms (headache and burning eyes), change in behaviour and~     adoption of the stove.~   "
56945|NCT02821637|"~     Obese and overweight children or teens can join the Prevention and Care of Pediatric Obesity~     and Pediatric Diabetes Organization of Mulhouse. Those patients who are no longer able to~     exercize because of their physical condition start an effort rehabilitation program at the~     Organization. The study will evaluate the impact of this rehabilitation program on quality of~     life and appetency to physical activity for these children and teens.~   "
56946|NCT02821624|"~     This first-in-human (FIH) study will provide the first safety and pharmacokinetic (PK) data~     for G1T38 in humans and will allow further development of G1T38 in patients with cancer.~   "
56947|NCT02821611|"~     The professional program in Physical Therapy is rigorous and demanding on students, resulting~     in high levels of fatigue, stress, and sleep disturbance that can impact student performance~     and wellbeing. This project seeks to investigate ways to reduce student stress, monitor their~     quality of sleep and possibly enhance their learning through the practice of meditation.~   "
56948|NCT02821598|"~     This study aims to evaluate the effects of Proprioceptive Neuromuscular Facilitation (PNF)~     patterns delivered to the upper limb, lower limb and trunk for promoting motor irradiation to~     the contralateral lower limb.~   "
56949|NCT02821585|"~     Recent studies have found that up to 45 % of patients with type 1 diabetes have metabolic~     syndrome, a cluster of conditions (abdominal obesity, hypertension, dyslipidemia, insulin~     resistance) that increase the cardiovascular risk. The investigators have observed in~     previous studies a strong association between the adherence to a Mediterranean diet and the~     prevalence of metabolic syndrome on patients with metabolic syndrome. However, no~     intervention has been realized on this population and the current recommendations (low fat~     diet) differ from the Mediterranean diet. A nutritional intervention on the principles of the~     Mediterranean diet could therefore play a role in the treatment of the metabolic syndrome in~     Type 1 diabetes patients. The main objective of this study is to examine the impact of a~     nutritional intervention on the waist circumference after 6 months of an intervention group~     (Mediterranean diet) versus a control group (low fat diet).~   "
56950|NCT02821572|"~     Immune thrombocytopenia (ITP) is an autoimmune disease characterized by a peripheral~     destruction of platelets responsible for bleedings.~      Monocytes/macrophages play a double role by phagocyting platelets recognized by~     autoantibodies and by maintaining the autoimmune response via their antigen-presenting cell~     functions.~      Fcgamma receptors (FcγR), that are represented by activating receptors (FcγRI, FcγRIIa,~     FcγRIII) and an inhibiting one (FcγRIIb), are involved in the regulation of macrophages and~     have been reported to be dysregulated in autoimmune diseases such as rheumatoid arthritis and~     systemic lupus erythematous.~      The aim of this study is to compare the expression of FcγR in patients with ITP on~     circulating monocytes and on splenic macrophages.~   "
56951|NCT02821559|"~     Raltitrexed is a potent thymidylate synthase (TS) inhibitor. Conversely to 5-fluorouracil~     (5FU), raltitrexed can be administered safely in patients with cardiovascular disease, as~     well as in patients with dihydropyrimidine dehydrogenase deficit. Since raltitrexed is~     administered in 15-minutes infusion, complications related to continuous infusion can be~     avoided, and it becomes a potential good candidate for locoregional treatments as hepatic~     intra-arterial or intra-peritoneal infusion. Despite these potential benefits over 5FU,~     clinical trials failed in their temptation to replace the 5FU in colorectal cancer patients,~     mainly due to raltitrexed toxicity at 3mg/m2 every 3 weeks. Oxaliplatin has demonstrated a~     synergic effect when combined with TS inhibitors, and its association with raltitrexed was~     evaluated at 130mg/m2 of oxaliplatin and 3mg/m2 of raltitrexed, every 3 weeks. Actually, one~     of the first-line standard regimens in metastatic colorectal cancer patients is the biweekly~     FOLFOX (85mg/m2 of oxaliplatin, and infusional 5FU) plus bevacizumab regimen, since a~     significant progression-free survival (PFS) benefit was observed over FOLFOX plus placebo.~     Biweekly administration of raltitrexed at 2mg/m2 demonstrated a favorable toxicity profile~     even in patients aged >65 years. Besides, the association of raltitrexed, oxaliplatin and~     bevacizumab seems safe.~      Then, the investigators decided to perform a randomized pharmacokinetic comparative study~     between biweekly TOMOX (raltitrexed 2 mg/m2 and oxaliplatin 85mg/m2) and triweekly TOMOX~     (raltitrexed 3 mg/m2 and oxaliplatin 130mg/m2) regimens in metastatic colorectal cancer~     patients, in a ping-pong crossover strategy to reduce the intra-individual variability.~     Bevacizumab was allowed at the dose of 5mg/kg or 7.5mg/kg, in biweekly and triweekly~     schedules, respectively. The secondary end-points were, objective response rate evaluated by~     RECIST 1.1 criteria, PFS, overall survival (OS), toxicity, and the comparison of toxicity~     between two arms for the first 2 cycles.~   "
56952|NCT02821546|"~     Aggressive hydration with lactated Ringer's solution (LRS) has been shown in a preliminary~     research to reduce the incidence of post-endoscopic retrograde cholangiopancreatography~     (ERCP) pancreatitis. This randomized, controlled trial was designed to assess the effect of~     peri-procedural aggressive intravenous hydration with LRS on the incidence of post ERCP~     pancreatitis.~   "
56955|NCT02821507|"~     Chondrosarcoma and liposarcoma consists of different subtypes with a wide range of patient~     survival. Current treatment options consist of wide surgical resection, however for patients~     with a local recurrence or metastatic disease the outcome is poor. New treatment options~     being evaluated and mouse models show in vivo that mammilian target of rapamycin (mTOR)~     inhibition can prevent tumour growth. mTOR is an kinase that is present in two complexes and~     thereby activates multiple pathways. Aberrant mTOR signalling is known to be involved in~     cancer cell survival. Several clinical studies for patients with bone or soft tissue sarcoma~     treated with mTOR inhibitors have been conducted and they show promising results. From these~     studies the investigators can conclude that the combination of an mTOR inhibitor with~     cyclophosphamide shows promising results in chondrosarcoma. With the lack of other treatment~     options for unresectable and metastatic chondrosarcoma or myxoid liposarcoma the Eurosarc~     consortium (www.eurosarc.eu) decided to treat these patients in a standardised way according~     to a common protocol with the combination of sirolimus and cyclophosphamide using the growth~     modulation index for evaluation in the current clinical study protocol.~   "
56956|NCT02821494|"~     A phase I study to establish the highest safe dose that induces HPV16 E6-specific T-cell~     responses, using the highly promising novel therapeutic vaccine concept named: Hespecta (HPV~     E Six Peptide Conjugated To Amplivant®) to induce HPV16 E6-specific T-cell responses.~   "
56957|NCT02821481|"~     The purpose for this study is to determine if beta-alanine supplementation combined with~     endurance-based resistance training can increase gains in muscular endurance to a greater~     extent than endurance-based resistance-training alone in older adults.~   "
56958|NCT02821468|"~     A previous multicenter trial led by Bioiberica S.A. has confirmed the efficacy and safety of~     DROGLICAN for the treatment of osteoarthritis (OA) in patients with severe pain. The MOVES~     study was a phase IV, double blind, randomized and non-inferiority trial to compare the~     efficacy and safety of a fixed dose combination of glucosamine hydrochloride (GH) +~     chondroitin sulfate (CS) (DROGLICAN) versus celecoxib in patient with symptomatic knee OA~     with moderate to severe pain. This study concluded that both drugs reduced the WOMAC Pain~     subscale by 50% without significant difference between groups. Further, there was no~     difference in all secondary outcomes assessing patient's pain, functional capacity,~     stiffness, inflammation, joint swelling, effusion, and overall quality of life.~      This new exploratory trial is aimed to evaluate the beneficial effect of DROGLICAN on the~     good health of the cartilage of patients suffering of knee osteoarthritis as revealed by~     qualitative assessment of cartilage biochemical composition in vivo.~   "
56959|NCT02821455|"~     The aims of the study is to determine if end-tidal concentrations of the anaesthetic gases~     isoflurane and sevoflurane as measured by a standard gas monitor are related to the blood~     levels during one-lung ventilation.~   "
56960|NCT02821442|"~     To evaluate the effectiveness of Electro acupuncture (EA) for treatment of persistent painful~     CIPN symptoms in patients with stages 1-3 breast cancer treated with docetaxel chemotherapy 6~     months prior~   "
56961|NCT02821429|"~     Respiratory weaning failure worsens prognostic of patients following on-pump cardiac surgery.~     There are increasing evidences that pulmonary, diaphragmatic or cardiologic echographies are~     useful in order to improve this critical medical status.~      Based both on a previous study conducted in the critical care unit of Purpan and on~     literature we hypothesize that a combined thoracic echography score could be of interest. We~     make the hypothesis that the use of a score based on thoracic combined echography (ETC =~     cardiac, pulmonary and diaphragmatic) allows to predict the failure of respiratory weaning in~     cardiac surgery and allows to improve the characterization of the causes of this failure~   "
56962|NCT02821416|"~     This is a randomized, double-blind, parallel group, placebo-controlled study designed to~     evaluate the effect of a fixed 30 mg dose of benralizumab administered subcutaneously every 4~     weeks on allergen-induced inflammation in subjects with mild atopic asthma challenged with an~     inhaled allergen.~   "
56963|NCT02821403|"~     Working Hypothesis: The blue-light blocking lens has no effect on the contrast sensitivity,~     accommodative response, color vision, and subjective grading of the quality of life and~     vision.~      Purpose: To determine and compare the visual performances after wearing the blue-light~     blocking lenses in participants with and without presbyopia.~      Methods: One hundred and sixty computer users (computer usage >2 hours/day) with (n=120, aged~     >40years) and without presbyopia (n=40, aged 18-35 years) will be recruited. Three pairs of~     ophthalmic lenses will be prescribed for the participants, in which one pair of them will be~     the blue-light blocking lenses (StressFree, Swisscoat, HK). The lenses will be used for~     intermediate vision (i.e., computer usage) in presbyopic group, and for distant vision in~     non-presbyopic group. The adaptation period for each pair of lenses will be 1 month. The pre-~     and post-treatment contrast sensitivity, accommodative response and color vision will be~     measured. The participants will also be asked to complete questionnaires about their quality~     of life and vision, and the performances of these ophthalmic lenses.~      Significance: The blue-light blocking lens reflects the short-wavelength lights and protects~     the retina from blue-light hazards; however, blue lights are essential for various visual~     function and circadian rhythms. This study will evaluate the impact of the blue-light~     blocking lenses on visual function and quality of life, and determine whether the blue-light~     blocking lenses are good choices for extra ocular protection.~   "
56964|NCT02821390|"~     The analgesic effect of Nepafenac 0.1% Ophthalmic Drops on ocular pain related to~     intravitreal injections will be evaluated.~      Pain perception will be assessed by the Short Form of the McGill Pain Questionnaire.~   "
56965|NCT02821377|"~     Introduction: Patients with chronic liver diseases are usually thin as a result of~     hypermetabolism and malnutrition expressed by reduced levels of leptin and impairment of~     other adyponectins such as visfatin.~      Aims: To evaluate the metabolic and inflammatory effects of intravenous high-dose furosemide~     plus hypertonic saline solutions (HSS) compared with repeated paracentesis and a standard~     oral diuretic schedule, in patients with cirrhosis and refractory ascites.~      Methods; All consecutive cirrhotic patients with refractory ascites unresponsive to~     outpatient treatment will be enrolled . Enrolled subjects will be randomized to treatment~     with intravenous infusion of furosemide (125-250mg⁄bid) plus small volumes of HSS from the~     first day after admission until 3 days before discharge (Group A ), or repeated paracentesis~     from the first day after admission until 3 days before discharge (Group B, ).~      Plasma levels of ANP, BNP, Leptin, visfatin, IL-1β, TNF-a, IL-6 were measured before and~     after the two type of treatment.~   "
56968|NCT02821338|"~     The objective of this study is to determine bioequivalence between two different formulations~     of lamotrigine extended release tablets (one reference product and one generic product) in a~     healthy adult population, following a single oral dose under fed conditions.~   "
56969|NCT02821325|"~     The purpose of the study: is to quantify the amount of post-operative effusion or hematoma~     present after total knee arthroplasty pre-operatively, post-operative day #0,1.~      Patients undergoing a total knee arthroplasty will undergo an MRI on the operative knee at~     the following times:~        -  Pre-operatively~        -  Post-operative day #1 (approximately 16-20 hours post op)~        -  Post-operative day #2 (approximately 36-40 hours post op) This will be conducted by the~          Loma Linda radiology department as per normal protocols. No special imaging procedures~          will be undertaken.~      Subjects will be both male and females, they will be patients from the Principle Investigator~     and Co-Investigators practice. Subjects will be between the ages of 18-89 years of age.~      The total participation will last approximately 30 days.~      Subject selection will be approximately 10 English speaking, both male and female between the~     ages of 18 to 89 years of age. Subjects will be recruited from the Principal Investigators~     and Co-Investigators clinic. There will be no advertising or electronic recruiting. The study~     is expected to last 12 months.~   "
56970|NCT02821312|"~     This study is a Phase I, Randomised, Double-Blind, Placebo-Controlled, Dose-Escalation Study~     to Evaluate Safety, Tolerability and Pharmacokinetics After Single and Multiple Oral~     Administration of DA-8010 in Healthy Subjects.~   "
56971|NCT02821299|"~     The experience of face and hand composite tissue transplantations reported in the~     international community have mainly concerned trauma patients. Feasibility and individual~     benefit have been demonstrated for these indications, in properly selected patients. The~     first laryngeal transplantation also concerned a case of post-traumatic reconstruction. A~     certain number of patients, who have suffered direct (extended period of intubation during a~     stay in the ICU, road traffic accident etc.) or indirect trauma (thermal or chemical burns)~     to the larynx, present irreversible trauma or injury to the larynx in which conventional~     treatments are unable to restore laryngeal function. These patients find themselves severely~     disabled, with a significant reduction in their quality of life. They suffer from~     stigmatization which leads to social isolation (professional and personal). In some~     circumstances, providing healthy tissue and anatomical or functional components (cartilage,~     muscle, nerves, blood vessels) by means of an allogeneic laryngeal transplantation, is the~     only way of allowing patients, whose quality of life has been seriously affected, to speak,~     breath and swallow normally. The extremely promising results from other international teams~     in this area have encouraged the investigators to present this project.~      The specificities of the protocol compared to previous transplantations carried out by other~     teams are:~        -  The technique for nerve re-innervation which should make it possible to decannulate all~          patients and improve functional outcomes in the graft.~        -  A dual therapy immunosuppressive regimen will be used, if the patient's clinical and~          biological status permits, which can be adjusted according to the type of tissue~          grafted.~      It might be thought that the need for immunosuppressive therapy means the indications will~     remain rare, representing an incidence of less than five patients a year in France. However,~     the interest of this research project does not reside in the number of patients concerned but~     rather the total lack of any existing therapeutic solution. Conducting a case series will~     help determine whether, under certain conditions, laryngeal transplantation can improve the~     management of patients for whom the usual reconstructive surgery options are unsatisfactory.~      The study is intended to provide a descriptive analysis of a case series of three laryngeal~     transplantations before and after comparisons, each patient serving as their own control.~   "
56972|NCT02821286|"~     This project intends the analysis and profiling of specific antibodies against major peanut~     allergens in peanut allergic individuals and molecular cloning of human antibodies against~     major peanut allergens.~   "
56973|NCT02821273|"~     In preterm infants with respiratory distress syndrome, mechanical ventilation is related to~     increased risk of death and complications. Surfactant is an important methods to reduce~     mortality and intubation rates. INSURE technique is a standard method to administrate~     surfactant. However, several preterm infants need two or more surfactant, and therefore one~     more intubation is needed. How to reduce the times of intubation is an challenges for~     neonatologists.~   "
56974|NCT02821260|"~     The Pediatric Neurosurgery Service of the Rothschild Foundation (Paris) is the French leader~     center for surgery of epilepsy in infants and children.~      Postoperative follow-up of these children is performed during medical and neurosurgical~     consultations in order to assess the frequency of attacks and to reduce medication.~      On average, two postoperative consultations are carried out between 3 and 5 months and~     between 12 and 18 months. Beyond 18 months, some children may benefit from long-term~     monitoring at this center, but most children are followed by their neurologist .~      Therefore, the center has no rigorous and systematic collection of standardized data on the~     outcome of these patients.~      The purpose of this study is to evaluate the efficacy of the epilepsy surgery in children~     with a monitoring of 3 years.~   "
56975|NCT02821247|"~     This is a prospective, observational, multi-center, study. The study will be conducted in~     approximately 12 ophthalmological clinics and practices throughout Greece. It is planned to~     collect data on treatment of wet Age related Macular Degeneration (wAMD) from about 120~     patients for which the decision to treat with intravitreal aflibercept injections is made at~     the discretion of the attending physician, according to his/her medical practice. Visits will~     be performed at baseline, aflibercept first injection (if different from enrollment) and at~     12 and 24 months. The 12 and 24 month comprise the data collection visits during which any~     data generated in the period preceding these visits will be recorded.~      All required information for the purposes of this study will be collected using electronic~     Case Record Form (eCRF). The web-based electronic data capture (EDC) application will be~     specifically designed for the needs of the study and will adhere to all applicable data~     protection regulations and requirements with regard to electronic records.~      The study observation period for each patient enrolled in this study is the time from the~     beginning of treatment with intravitreal aflibercept injection up to two years or until~     discontinuation of intravitreal aflibercept injection-treatment due to any reason including~     withdrawal of consent or patient loss from follow-up.~   "
56988|NCT02821052|"~     This trial is conducted in Asia. The aim of this Non-interventional study is to investigate~     the long-term safety and effectiveness of Ryzodeg® (insulin degludec/insulin aspart) in~     Japanese patients with diabetes mellitus requiring insulin therapy under normal clinical~     practice conditions.~   "
56989|NCT02821039|"~     The Turkish Thoracic Society Usual Interstitial Pneumonia Registry (TURK-UIP) is a~     collaborative project to coordinate a team of investigators from various regions of Turkey.~     The purpose of the Registry is to collect epidemiological data on patients with idiopathic~     pulmonary fibrosis and other causes of UIP, and to obtain information about the natural~     course of the disease and the treatment response.~   "
69246|NCT02660580|"~     The purpose of this study is to compare the efficacy, safety and immunogenicity of MSB11022~     and Humira® in adult subjects with moderate to severe chronic plaque type psoriasis.~   "
56976|NCT02821234|"~     One-tenth of the population suffers from insomnia, increasing their risk on other health~     problems such as depression. Self-reported sleep quality only was historically leading for~     insomnia diagnosis, but more recently a state of 24-hour hyperarousal has been associated~     with insomnia, either physiological (increased heart rate, higher frequency EEG) or~     predominant cognitive-emotional hyperarousal (worry, rumination, repetitive thoughts). Strong~     evidence shows that those suffering from insomnia with physiological hyperarousal are at~     higher risk of short and long term severe health problems such as inflammation and~     hypertension than the group without physiological hyperarousal. The neurophysiological basis~     of these insomnia phenotypes has however barely been investigated, although its results can~     have major consequences for how this limiting condition will be treated.~      To support the development of a differential diagnosis of insomnia, structural and functional~     brain connectivity in insomnia patients with different levels of hyperarousal will be~     investigated and related to sleep variables. Investigators will compare the insomnia group to~     a normal sleeping control group. Investigators expect that the emotion processing circuit~     (amygdala-ventromedial prefrontal cortex) is a) more affected in insomniacs compared to~     normal sleeping controls and b) the directionality of this effect to depend on the level and~     type of hyperarousal in insomniacs. Further, investigators expect c) amygdala activity to be~     positive correlated with physiological hyperarousal level and d) prefrontal activity to be~     positively correlated with cognitive-emotional hyperarousal level. Investigators expect a~     higher physiological hyperarousal level to be reflected in affected afferent pathways of the~     amygdala towards the ventromedial prefrontal cortex and investigators expect higher~     cognitive-emotional hyperarousal to be related to affected efferent pathways from the~     ventromedial prefrontal cortex to the amygdala. Investigators expect sleep quality to play a~     mediating role in both types of hyperarousal and their brain activation patterns in insomnia~     patients and normal sleeping controls.~      These data can lead to the definition of new insomnia phenotypes and to new customized and~     effective insomnia treatment, focused not only on improving sleep but also on changing~     dysfunctional hyperarousal levels that currently put insomniacs at risk of numerous severe~     health problems.~   "
56977|NCT02821208|"~     The goal of this study is to identify the prognostic factors of quality of life in patients~     with psychogenic non-epileptic seizures~   "
56978|NCT02821182|"~     We hypothesize that combining anti-PD1 treatment with radiotherapy might result in improved~     clinical response rates and PFS compared to anti-PD1 treatment in monotherapy.~      The current phase II trial aims at exploring the suggested benefits of the combination and~     aims to improve local and distant tumour responses by exploiting the pro-immunogenic effects~     of radiotherapy in addition to anti-PD1 treatment.~   "
56979|NCT02821169|"~     Endoscopic sinus surgery (ESS) is a prevalent surgical procedure. It is required in many~     chronic rhinosinusitis for whom the medical treatment failed. In order to improve the~     postoperative management of patients treated with ESS, we aim to assess the analgesic action~     of local injection of ropivacaine in the nasal fossa.~   "
56980|NCT02821156|"~     This is a prospective, observational, multicenter study conducted during 1 year in adult and~     paediatric intensive care units equipped with the EZ-KINOX™ system.~      A maximum of 250 patients (newborns to adults, suffering from Pulmonary Arterial Hypertension~     (PAH) associated with cardiac surgery or Persistent Pulmonary Hypertension in the Newborn~     (PPHN) receiving iNO through the integrated delivery and monitoring EZ-KINOX™ system was~     planned to be included.~      The study is strictly non-interventional with the aim of describing current practices and~     therefore did not affect the patient usual management.~   "
56981|NCT02821143|"~     Investigators hypothesize that telemedicine may be an effective tool to improve palliative~     care in nursing home, by providing on-site specialized and interprofessional consultation.~     The objective of this study is to assess the impact of telemedicine in decreasing the rate of~     hospitalization, compared with usual care, in nursing home resident with palliative care~     needs.~   "
56982|NCT02821130|"~     Shortness of breath (dyspnea) during exercise is a major source of distress and is a commonly~     reported symptom in patients with cystic fibrosis (CF). A recent treatment option known as~     Orkambi, which combines the drugs lumacaftor and ivacaftor, may be used in patients with CF~     to help improve lung health. However, the effects of this combination therapy on dyspnea and~     exercise performance, a known predictor of survival in CF, are not clear. The investigators~     aim to understand the effects of Orkambi on these symptoms and to gain new insight into the~     potential health improvements in CF from using this treatment option.~   "
56983|NCT02821117|"~     The study is designed to determine glycaemic control achieved using the FreeStyle Libre Flash~     Glucose Monitoring System (FreeStyle Libre) versus Self-Monitoring Blood Glucose (SMBG) for~     the self-management of diabetes.~   "
56984|NCT02821104|"~     This study evaluates how genetic variations in complement, a part of the immune system,~     affect cardiovascular risk in adolescents.~   "
56985|NCT02821091|"~     Aim 1: Determine the relationships between muscle quality and balance performance as well as~     any association with fracture and fall history in older adults.~      Muscle quality will be calculated from the information of muscle strength and body~     composition (strength/lean muscle mass). The investigators will compute the joint torque~     during functional activates using biomechanical data from the 3-D motion analysis, whereas~     the lean skeletal muscle mass will be determined by the bioelectrical impedance analysis~     (BIA). Clinical and functional assessments for balance performance will also be conducted.~     Fracture and fall history prior to the testing will be recorded retrospectively.~      Aim 2: Identify the relationships between force usages during balance perturbation in older~     adults.~      Lateral and forward/backward perturbation while walking will be used to elicit balance~     recovery responses. The degree of necessary joint force and how this relates to a person's~     functional capacity at specific joint levels will be determined by the torque demand to~     capacity ratio (DCR: task demands relative to strength capacity). The DCR provides a~     joint-specific unified scalar quantity representing the balance recovery demand normalized by~     the maximum muscle strength capacity of an individual. It would indicate whether a person can~     recover balance and to what extent of his/her maximum capacity is taxed.~      Aim 3: Examine the effectiveness and long-term effects of a novel 2-month personalized~     strengthening and balance training program on improving balance performance in older adults.~      Personalized strengthening and balance training exercise will be personalized based on the~     results of biomechanical assessments, using the Modular Interactive Tiles System (MITS) and~     split-belt balance perturbation instrumented treadmill. The exercise group will receive~     training 2 times a week for 2 months and the age-matched control group will maintain their~     usual daily life activities. All assessments will be performed at baseline, and 1 week after~     training. Follow-up telephone interviews will be conducted at 6, 9, and 12 months following~     the training period.~   "
56986|NCT02821078|"~     The objective of the project is to establish the 3D velocity mapping of the hepatic~     vasculature and its consistency. Specifically, the investigators will assess the consistency~     of the quantitative data by measuring hepatic blood Inflow (hepatic artery + portal vein) and~     outflow (inferior vena cava differential flow). According to the mass conservation physical~     property, blood inflow must equals blood outflow. The relative gap between the measured~     values will characterize the consistency of the acquisition.~   "
56987|NCT02821065|"~     Modern technology like computers, smartphones and the Internet enable patients to measure~     certain health indicators, like blood pressure and body weight, from the comfort of their own~     homes. This information can also be shared electronically with doctors and other healthcare~     providers to monitor remotely. This is called home health monitoring. In TEC4Home, we are~     developing a home monitoring solution for patients with heart failure to support their care~     and recovery at home after a visit to the emergency department. We hope to show that this~     solution decreases revisits to the emergency department and increases quality of life for~     patients.~   "
57001|NCT02820883|"~     This is an open-label, dose-escalation pilot study with a total of 30 participants with 10~     per dosage group. The aim of the pilot study is to explore the preliminary safety of an~     experimental recombinant staphylococcus aureus vaccine.~   "
56990|NCT02821026|"~     Islet transplantation is a relatively new procedure used in people with difficult to control~     Type 1 diabetes. Insulin producing cells (islets) are isolated from a pancreas of a deceased~     organ donor. After the cells are carefully prepared, the islets are transplanted into~     patient's body. These transplanted islets may produce insulin for the patient. Patient may be~     able to reduce or eliminate the need for insulin injections for an unknown period of time.~     Patients who receive an islet transplant may need to stay on powerful immunosuppressive drugs~     for as long as the islets remain alive and working. These drugs help to prevent the immune~     system from attacking the transplanted islets.~      Under current standard of care procedure, islets are transplanted into patient's liver. The~     investigators have learned that some of these cells do not survive the current procedure and~     are lost around the time of transplant. Therefore in this study, the investigators are~     studying a new transplant procedure that may help prevent this islet cell loss. The new~     procedure involves transplanting the islets into an omental pouch instead of into the liver.~     The omentum is a large apron-like fold of membrane inside the abdomen that drapes over the~     intestines. This study will test to see if omental islet transplantation is safe and~     effective. Standard immunosuppressive medicines (anti-thymocyte globulin, tacrolimus,~     mycophenolic acid, sirolimus, etanercept) will be used in this study to prevent rejection of~     the islets.~      This study is a collaborative research with the University of Miami, and the same study~     protocol has been in use over there. Recruitment in Edmonton will continue until all subjects~     [N=6] needed for the study are transplanted. All subjects in this study will receive islet~     transplants using the study procedure.~   "
56991|NCT02821013|"~     The purpose of this study is to compare the effects on patients with metastatic melanoma of~     taking a government approved and paid-for PD-1 inhibitor intermittently, with taking the same~     type of agent continuously. Researchers want to see if the two ways of giving this type of~     treatment work equally well in extending the life of patients with melanoma, or not.~   "
56992|NCT02821000|"~     The purpose of this study is to determine the safety, tolerability, and objective response~     rate (ORR) of pembrolizumab (MK-3475) in Chinese participants with locally advanced or~     metastatic melanoma, with disease progression following first line chemotherapy or targeted~     therapy. ORR will be based on Response Evaluation Criteria in Solid Tumors version 1.1~     (RECIST 1.1).~   "
56993|NCT02820987|"~     This study evaluates PK/PD of an extended-infusion protocol of meropenem,~     piperacillin-tazobactam and cefepime, in the early phase of septic shock.~   "
56994|NCT02820974|"~     There lacks effective early screen system for the migraine-susceptible women during the~     peri-menopause period. The processing of acute pain and cognition as well as the underling~     functional magnetic resonance imaging (fMRI) features are suitable for screening~     pain-susceptible individual. However, there is no study on this issue among the large sample~     peri-menopause women. The investigators thus designed the current trial to investigate the~     processing of acute pain and cognition as well as the underling featured functional magnetic~     resonance imaging (fMRI).The investigators will combine pain behavior,cognitive task, fMRI~     analysis, psychophysiological interaction (PPI) and suitable statistical package to~     investigate the relationship between the above mentioned features and the occurrence of~     migraine and then test the efficacy of these features in predicting migraine development. The~     investigators will then try to establish the screening system for migraine-susceptible~     individuals in peri-menopause women.~   "
56995|NCT02820961|"~     The purpose of this study is to determine the effect of exemestane on the pharmacokinetics~     (PK) of entinostat and to determine the effect of entinostat on the PK of exemestane in~     patients with locally recurrent or metastatic estrogen receptor positive (ER+) breast cancer.~     Additionally, this study will evaluate the safety and tolerability of entinostat in~     combination with exemestane, and assess the effectiveness of entinostat in combination with~     exemestane in terms of best overall response and overall survival.~   "
56996|NCT02820948|"~     A prospective, randomized study was performed. The patients were randomized into 2 groups:~     those patients undergoing subcutaneous vitamin E ointment application (Group 1) and those~     patients who not (Group 2).~      Incisional surgical site infection (SSI), microbiological cultures from the infected surgical~     wounds, postoperative pain and acute phase reactants were investigated.~   "
56997|NCT02820935|"~     This is a two-part study to be conducted at a single study site in the US. Both parts of the~     study may be conducted in parallel.~      A total of approximately 38 subjects will participate in this study, with approximately 19~     subjects in Part 1 and approximately 19 subjects in Part 2. Each subject may only participate~     in one of the parts.~   "
56998|NCT02820922|"~     The aim of this retrospective study is to evaluate the preferred anaesthesia techniques in~     our clinic for emergency orthopedic surgery at a 1 year period.~   "
56999|NCT02820909|"~     The femoral approach is the preferred vascular access for the set-up of emergency catheters~     in severely traumatized patient. This location combines simplicity and speed of installation,~     it allows the simultaneous set-up of arterial and venous catheters, and is a provider of few~     complications and failures.~      The ultrasound guidance has greatly reduced installation times, failures and complications~     related to the set-up of central venous catheter. This was amply demonstrated in the internal~     jugular and subclavian site outside of extreme emergency situations (Fragou M et al 2011,~     Farrell J et al 1997, Karakistos et al 2006). The benefit of ultrasound guidance for the~     set-up of arterial and venous catheters in the femoral emergency has not been evaluated in~     terms of reduction in complications.~      Then the main objective of this study is to demonstrate that the ultrasound guidance reduces~     early complications related to the set-up of arterial and venous catheters in the femoral~     emergency, among severely traumatized patient compared to the reference anatomical technique.~   "
57000|NCT02820896|"~     This is a Phase I, randomized, placebo-controlled, double-blind study to evaluate the safety,~     tolerability, pharmacokinetics, and preliminary activity of RO7105705 in two participant~     populations: healthy participants and participants with mild-to-moderate Alzheimer's disease.~     This study is a single dose, dose-escalation, and multiple dose study comprising~     approximately six single dose cohorts in healthy participants administered RO7105705, either~     intravenously (IV) or subcutaneously (SC), and comprising one or more multiple dose cohorts~     in healthy participants administered RO7105705 IV every week (QW), a total of 4 doses, and~     one or more multiple dose cohorts in participants with Alzheimer's disease administered~     RO7105705 IV QW, a total of 4 doses.~   "
57002|NCT02820870|"~     The investigators are trying to understand the impact of the new VA/DoD cholesterol~     guidelines on primary care clinics and what the VA or the clinic could do to help clinicians~     and teamlets improve their statin use. To do this, the investigators will talk to providers~     about these guidelines and perform a brief intervention to help providers meet the~     guidelines' recommendations.~   "
57003|NCT02820857|"~     Poorly differentiated neuroendocrine carcinomas (NEC) are a sub-group of aggressive~     neuroendocrine neoplasms (NEN). The most common primary sites are broncho-pulmonary and~     digestive. The gastroentero-pancreatic NECs (GEP-NEC) represent 7-21% of all of the NENs.~      Recent data on the initial presentation of GEP-NEC have been reported in two retrospective~     studies and a French cohort study. No standard second-line treatment has been defined for~     NECs. Despite a very negative prognosis, these NECs have a certain amount of~     chemosensitivity, close to that of bronchial NECs. Multiple-drug therapies such as Folfiri,~     or Folfox, or single drug treatments such as temozolomide are the proposed options but with a~     low level of proof Bevacizumab associated with a cytotoxic chemotherapy has shown promising~     results in well differentiated neuroendocrine tumors (NET), known for being hypervascular.~     The efficacy of bevacizumab has also been suggested in patients with NEC, but never in the~     context of a phase II study. Its combination with Folfiri is efficient and well tolerated in~     metastatic colorectal cancer. The combination Folfiri-bevacizumab potentially represents an~     optimized treatment compared to chemotherapy with only Folfiri. No phase II or III studies~     have reported results for these patients, and no on-going phase II or III trial have been~     identified to date.~      The main objective of this study is to show that, after the failure of a first-line~     chemotherapy using platinum-etoposide, the combination Folfiri-bevacizumab allows significant~     prolongation of overall survival in adult patients with GEP-NEC.~   "
57004|NCT02820844|"~     GSK1358820 is a botulinum neurotoxin A complex that has been approved for the treatment of~     overactive bladder (OAB) in several countries, however, it has not been approved for OAB~     treatment in Japan. This study has been planned to evaluate the efficacy and safety of~     GSK1358820 in Japanese OAB patients with urinary incontinence whose symptoms have not been~     adequately managed with other medications for OAB.~      The primary objective of this study is to evaluate the superiority of a single dose treatment~     of GSK1358820 100 units (U) compared with placebo.~      The study comprises a screening phase up to 28 days, followed by a double-blind treatment~     phase of 12 to 48 weeks wherein subjects will receive a single treatment of either GSK1358820~     100 U injection or Placebo injection, in a ratio of 1:1, with further stratification within~     the treatment arms according to the number of urinary urge incontinence episodes during~     screening. Subjects meeting the criteria for re-treatment will receive a second and third~     treatment. Each re-treatment will be with open-label GSK1358820 100 U injection, and will be~     spaced at least 12 weeks from the previous treatment.~      The total duration of participation for any subject will not exceed 52 weeks, including~     screening and the 48-week treatment period.~   "
57005|NCT02820831|"~     A prospective observational cohort study to assess the predictive value of preoperative~     frailty on postoperative quality of life in peripheral vascular surgery patients.~   "
57006|NCT02820818|"~     Preterm birth alters the normal sequence of lung development with lasting respiratory~     consequences. It is still unclear whether observed respiratory morbidities in preterm born~     individuals reflect sequelae from a non-progressive lung disease that occurred early in life~     or result from ongoing active disease that, if left undiagnosed and untreated, could increase~     the risk of a COPD-like phenotype. We propose to examine micro-structural abnormalities of~     the lung using innovative non-invasive imaging technologies in relation to pulmonary function~     and markers of inflammation and oxidative stress in young adults born preterm.~   "
57007|NCT02820805|"~     The purpose of this study is to determine the effect of carbohydrates on blood glucose~     levels, subjective appetite, mood, and memory performance in 9 to 14 year old normal weight~     (NW) and overweight or obese (OW/OB) children.~   "
57008|NCT02820792|"~     The LMA ProtectorTM is a new extraglottic airway device which brings together features of~     both the LMA ProSealTM (high seal cuff, gastric access and bite block - to facilitate~     ventilation, airway protection and airway obstruction, respectively) and the LMA UniqueTM~     (single use - prevention of disease transmission). In the following randomized study the~     investigators test the hypothesis that ease of insertion, oropharyngeal leak pressure,~     fiberoptic position and ease of gastric tube placement differ between the LMA ProtectorTM and~     the Ambu AuraGainTM in paralyzed, anesthetized patients.~   "
57009|NCT02820779|"~     The purpose of this study is to evaluate the effectiveness, long-term safety and explore the~     safety and efficacy factors WILLIS™ intracranial stent graft system in clinical applications.~   "
57010|NCT02820766|"~     The primary objective of the study is to determine how the short-term outcome of subjects~     implanted with the JOURNEY™ II BCS Total Knee System compares to subjects implanted with~     other PS total knee systems, and to determine if there is a difference in health care~     resources consumed that may result in economic savings to patients, the facility and/or the~     payer.~      To address the study objectives, patient self-assessment questionnaires, and other objective~     measures of post-operative function and health care resource utilization will be used for~     data collection.~   "
57011|NCT02820753|"~     This study will leverage available technologies and test strategies to impart the Universal~     Medication Schedule (UMS) in primary care to help patients understand, consolidate, safely~     use, and adhere to their complex medication regimens.~   "
57012|NCT02820740|"~     Multicenter, open-label, prospective designed study to characterize the performance of brain~     laser interstitial thermal therapy (LITT) ablation using the Monteris NeuroBlate System for~     the treatment of drug-refractory medial temporal lobe epilepsy in subjects who are candidates~     for LITT surgery.~   "
57013|NCT02820727|"~     This study addresses the influence of anesthesia induction, ventilation and influence of~     cardiac surgical procedures and cardio-pulmonary-bypass on right ventricular function.~     Influence on patient outcome is also studied. Three dimensional echocardiography is applied.~   "
57014|NCT02820714|"~     The objective of this study is to evaluate BLI801 laxative in adults experiencing~     non-idiopathic constipation.~   "
57015|NCT02820701|"~     This prospective, randomized, controlled trial is proposed to investigate the effect of OMT~     on sacral base asymmetry as assessed by ultrasound.~   "
57016|NCT02820688|"~     This prospective, randomized, double blind study aims to determine the optimal volume for~     adequate sensorial and motor blockade following an infraclavicular block. Patients will be~     randomized into three groups. Using a constant dose of local anesthetics (45mg bupivacaine~     180mg prilocaine), different volumes will be used in each of the groups (First group; 18mL,~     second group; 27mL, third group; 36mL). Onset, duration and quality of sensory and motor~     block will be compared for patients between groups~   "
57017|NCT02820675|"~     The German Quality Network Sepsis is an association trying to improve quality of care for~     patients with sepsis, severe sepsis and septic shock or being in risc thereof.~      The icosmos trial investigates the impact on the use of routine data, a risk adjustment~     algorithm and feedback to all hospitals as well as a structured implementation for regular~     screening for deteriorating patients, and education on in-hospital mortality.~   "
57018|NCT02820662|"~     The development of the retinal vascular network is generally complete during the 3rd~     trimester of pregnancy but may continue during the first 15 days of life. This late~     maturation may cause problems in pre-term births and may result in immature vascularization~     of the retina, a condition called retinopathy of prematurity. Among the different factors~     affecting the development of the retinal vasculature, the tissue level of omega-3~     polyunsaturated fatty acids (PUFA) appears to be a crucial element, as does the form of the~     PUFA present in the tissues (nature of the phospholipids in their membranes). This project~     aims to show a possible association between levels of omega-3 PUFA and the onset of~     retinopathy of prematurity (ROP).~   "
57019|NCT02820649|"~     Rationale. Sleep loss is a risk factor for cardiovascular events mediated through endothelial~     dysfunction.~      Objective. To determine if 7 weeks of exercise training can limit cardiovascular dysfunction~     induced by total sleep deprivation (TSD) in healthy young men.~      Methods: 16 subjects will be examined during 40-h TSD, both before and after 7 weeks of~     interval exercise training. Vasodilatation induced by ACh, insulin and heat (42°C) as well as~     pulse wave velocity (PWV), blood pressure and heart rate (HR) will be assessed at baseline,~     during TSD, and after one night of sleep recovery. Biomarkers of endothelial activation,~     inflammation, and hormones will bemeasured from morning blood samples at 07:00~   "
57020|NCT02820636|"~     The study is about developing the best aftercare treatment possible for Latino/a adolescents~     who have been hospitalized in a psychiatric unit due to a suicidal crisis (suicidal thoughts~     or attempts). The treatment's purpose is to help adolescents and their caregivers develop~     skills to prevent future suicidal crises. Latino/a adolescents usually report more suicidal~     behavior than other ethnic groups. The question that the investigators want to answer is if a~     new treatment (socio-cognitive behavioral therapy-(SCBT)) developed to their specific needs,~     taking into account their culture and aspects of adolescence, performs better than the~     treatment that they usually receive. Fifty adolescents will be recruited from the Bradley~     Hospital adolescent inpatient unit or the Hasbro Inpatient Medical & Psychiatric Program, or~     referred to Gateway Healthcare after discharge from other inpatient units in Rhode Island;~     half of them will be assigned randomly to the treatment they would usually receive (TAU) and~     the other half to the new treatment (SCBT). In both groups, caregivers and adolescents will~     have to complete questionnaires and interviews before the beginning of treatment and at 3, 6,~     and 12 months after the treatment begin. Questions to the participants will be related to~     their presenting symptoms, family, social group, problems, and other similar topics. Also,~     participants will be asked about their satisfaction with the treatment they are receiving.~     The purpose of the questionnaires and interviews are to follow their progress in therapy. At~     the end, comparisons will be made between the group who participated in TAU and the group who~     participated in the SCBT, based on the assessment results from the adolescents and~     caregivers.~   "
57021|NCT02820623|"~     The objective is to compare the accuracy, costs, and cost-effectiveness of three fidelity~     measurement methods to assess fidelity to cognitive-behavioral therapy for youth. The~     investigators will randomize 135 therapists, implementing cognitive-behavioral therapy, to 3~     conditions: self-report, chart stimulated recall, and behavioral rehearsal (N = 45 for each~     group). To calculate the outcomes of interest, each condition will be compared to the~     gold-standard fidelity measurement method, direct observation.~   "
57022|NCT02820610|"~     It is important to keep children undergoing laparoscopic surgery pain free with rapid return~     to normal activity.~   "
57023|NCT02820597|"~     This pilot study is a single arm study designed to evaluate the feasibility of cryoablation~     in the nasal passageway using the ClariFix Device, to reduce the symptoms of chronic~     rhinitis.~   "
57024|NCT02820584|"~     Mono-center, un-controlled, open label, first in human, clinical trial. Approximately 20~     patients (in order to achieve 12 valuable patients). The expected accrual time would range~     between 12 and 18 months. Follow-up, including clinical, immune and radiological monitoring~     will end two years after the initial surgery of the last patient enrolled. The primary~     objective will be to assess the activity of immunotherapy in terms of its effect on immune~     response. In particular we will investigate the effect of treatment on effector cells~     including CD8 T cells, NK cells and Natural Killer T (NKT) cells. The sample size of 12~     eligible patients was identified on ethical and practical considerations, rather than by a~     formal sample size calculation.~   "
57025|NCT02820571|"~     The OPAL study is about health outcomes in older adults. The investigators are surveying~     4,000 adults across England to see how health and physical activity change over time. The~     information that is collected will help the investigators to understand how a person's~     health, including conditions such as back pain, affect their mobility as they age, and~     provide insight into improving the management of health in older adults.~   "
57026|NCT02820558|"~     This study evaluates the delivery of substance P via the celiac artery in the treatment of~     recent onset type 1 diabetes.~   "
57044|NCT02820324|"~     The primary objective is to evaluate the analgesic efficacy of intravenous (IV) oliceridine~     administered as needed (PRN) compared with placebo in patients with moderate to severe acute~     pain after abdominoplasty.~   "
57045|NCT02820311|"~     The purpose of this study is to evaluate if TD-4208, an investigational drug being developed~     to treat people with chronic obstructive pulmonary disease (COPD), has any effect on the~     electrical activity of the heart.~   "
57046|NCT02820298|"~     The purpose of this study is to investigate the effect of a high-fat meal on the levels of~     bexagliflozin in the blood in healthy subjects.~   "
57027|NCT02820545|"~     The study aims to construct and validate a self-administrated questionnaire to assess the~     patients' perception of patient safety in surgical care units. The originality of the study~     is to perform sociological interviews of hospitalized patients to assess their own perception~     on the safety of their care and to create corresponding items which will be included in a new~     questionnaire. In a second step, patients' perception of patient safety will be assessed in~     numerous surgical care units in France, in order to analyze the psychometric properties of~     the questionnaire and consequently to validate the questionnaire. The patients' perception~     will be compared to the healthcare professionals' perception on patient safety and to the~     patient safety strategies in place in the care units.~   "
57028|NCT02820532|"~     Tumor motion increases the uncertainty in Radiation Oncology. Couch tracking can compensate~     for this uncertainty. However it is not known if the couch motion influences the respiratory~     pattern of the patients. This will be evaluated in this study on healthy volunteers.~   "
57029|NCT02820519|"~     Loxapine is an antipsychotic drug approved for the treatment of schizophrenia in several~     countries including the United States. In animal studies in mice, loxapine reduced~     neuropathic pain. Hence, in a proof-of-principle and dose-escalating study the tolerability~     and analgesic efficacy of loxapine will be evaluated in patients with neuropathic pain.~   "
57030|NCT02820506|"~     The aim of the study is to evaluate the feasibility of applying the SLN mapping technique in~     combination with FDG-PET/CT imaging in women with high-risk histology endometrial cancer and~     in patients with cervical cancer tumour size 2-4 cm.~   "
57031|NCT02820493|"~     Anti-cytokine antibodies, such as Infliximab (an anti TNF alfa chimeric antibody) and~     Adalimumab (an anti TNF alfa humanize antibody), have been developed and used in clinical~     practice for the treatment of patients with Crohn disease (CD). Unfortunately, their efficacy~     is limited. Based on these concepts, a new drug has been developed for IBD treatment.~     Vedolizumab (VDZ) is able to recognize the α4β7 heterodimer, and selectively blocks gut~     lymphocyte trafficking.~      The hypothesis of this study is that VDZ therapy may be to halt CD disease progression during~     time and modifying its natural history, using Lemann Index.~   "
57032|NCT02820480|"~     Rehab in a Crate is a therapy gym designed to be affordable, compact and easily~     transportable. The purpose of this particular study is to gain feedback on the initial design~     of the Rehab in a Crate system. This will be accomplished by using qualitative ethnographic~     research methods (i.e. human centered design) in the form of surveys that have been carefully~     designed by members of the research team. The eligibility criteria of this survey research~     reflects the intended user base of an eventual finished product, which is survivors of stroke~     and cerebral palsy across the globe. And while healthcare professionals are not the user base~     per se, their expertise and feedback should be instrumental in the design of future~     iterations of the Rehab in a Crate. Ease of use, utility, design, and various features, both~     existing and intended, will all be surveyed items.~   "
57033|NCT02820467|"~     Investigators conduct a monocentric pilot study with the objective to determine the~     hemodynamic parameter of fluorescence angiography (slope, amplitude, saturation time ) best~     correlated with toe pressure in patients with suspicion of critical limb ischemia.~   "
57034|NCT02820454|"~     RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. AGuIX particles~     may increase the effectiveness of radiation therapy by making tumor cells more sensitive to~     radiation.~      PURPOSE: This first-in-man Phase I trial will study the side effects and best dose of AGuIX~     when injected together with whole brain radiation therapy in treating patients with multiple~     brain metastases. The effectiveness of the combination of AGuIX and radiation therapy will be~     also assessed.~   "
57035|NCT02820441|"~     The study evaluate the effect of adaptative servoventilation (ASV) initiation combined with~     14 days Zopiclone vs Placebo treatment in patients with central sleep apnea (CSA) syndrome.~   "
57036|NCT02820428|"~     Non-motor symptoms like mood fluctuations and behavioral disorders are frequent in~     Parkinson's disease. They may be induced by both the pathology and the dopaminergic treatment~     and must be considered in treatment policies.~      Due to their specificity and the absence of an appropriate evaluation tool, behavioral~     disorders are rarely searched for.~      Therefore, investigators developed a scale permitting qualitative and quantitative evaluation~     of behavior according to the severity of the disorders.~      This study aims to define reference values for healthy individuals~   "
57037|NCT02820415|"~     Oocyte accumulation by vitrification is a valid strategy to increase the number of available~     embryos for biopsy and the number of viable euploid embryos to transfer after preimplantation~     genetic testing.~   "
57038|NCT02820402|"~     Project Viva is a prospective cohort study of maternal and child health, following over 2,000~     mother-child pairs from the mother's pregnancy into the child's adolescence.~   "
57039|NCT02820389|"~     This study aims to evaluate whether the use of Computed Tomography Colonography (CTC) for~     patients with low to intermediate risk of suspected colorectal cancer decreases overall NHS~     costs and waiting times whilst increasing patient satisfaction compared to clinical practice~     with utilisation of Optical Colonoscopy.~   "
57040|NCT02820376|"~     The purpose of this study is to assess the degree of agreement of the measurement of~     differential renal function in living donors by CT (computed tomography) and SPECT (single~     photon emission computed tomography).~   "
57041|NCT02820363|"~     The purpose of this study is to demonstrate the safety and effectiveness of CERAMENT™|G used~     in conjunction with standard-of-care treatment compared to standard-of-care treatment alone~     in the care of subjects with open fractures of the tibial diaphysis.~   "
57042|NCT02820350|"~     The SCD (Selective Cytopheretic Device) is an extracorporeal device used as an adjunct to~     renal replacement therapy (RRT) to improve the outcomes of pediatric patients with acute~     kidney injury (AKI). Funding Source - FDA OOPD (SCD-PED-01)~   "
57043|NCT02820337|"~     The main goal of our project is the study of subcutaneous and visceral (SAT and VAT) adipose~     tissue taken during bariatric surgery (Single port sleeve gastrectomy) of subjects with HIV~     infection, anf morbid obesity with undetectable viral load (VL) and having HIV~     lipohypertrophy particularly truncal. The study covers both the morphology of~     adipocytes,fibrosis, immune activation and inflammation, gene expression, pharmacology of~     antiretroviral drugs (ARV) and the measurement of viral replication in the adipose tissue and~     the plasma before and after bariatric surgery.~   "
57047|NCT02820285|"~     Recent epidemiological studies in France showed a high prevalence of obesity (14.5%) and its~     strong increase in the last 20 years. Among the many complications associated with obesity,~     liver complications (steatosis and steatohepatitis [NASH]) are among the most common.~     Semaphorins were described in the early 1990. More than 20 types of these proteins have been~     reported to date. These proteins were used for neural development. Since many functions have~     also been described. The semaphorins are involved in numerous physiological or~     physiopathological processes (cardiac morphogenesis, vascular growth, tumor progression), the~     regulation of immune cells and liver fibrosis. Preliminary studies have allowed to show that~     dendritic cells infiltrate adipose tissue and initiate the activation of T cells and~     inflammation. Immune semaphorin are new players in the regulation of inflammation and immune~     reactions.~      The role of immune semaphorin in regulating inflammation in the two compartments (liver and~     adipose tissue) could be a crucial step that could lead to more severe liver damage. Its~     dysregulation could explain NASH injuries. The goal is to identify a new mode of regulation~     of cellular homeostasis in the fatty liver disease. These factors may serve as diagnostic~     markers or future therapeutic targets.~   "
57048|NCT02820272|"~     Negative pressure wound therapy (NPWT) is a technique using vacuum dressing to promote wound~     healing in complicated wound. However for many patients, the application and removal of the~     NPWT is source of procedural pain. Some techniques had been reported to reduce these pain~     such as administering topical lidocain or normal saline solution before the dressing change.~     The authors hypothesized that administering cold water into the NPWT sponge would decrease~     pain during dressing changes.~   "
57049|NCT02820259|"~     The purpose of this study is to demonstrate that the biliary concentration of TCR is a good~     marker of its immunosuppressive activity.~   "
57050|NCT02820246|"~     Malnutrition at hospital admission is a risk factor for an unfavourable outcome, prolonged~     hospital stay and delayed recovery. In these patients the incidence of complications such as~     nosocomial infections, poor ventilatory function, prolonged bed rest is increased. In~     addition a relevant proportion of patients have a nutritional intake below their needs during~     hospitalisation.Mortality has been shown to be up to 8 times higher and dependency at~     discharge up to 3 times more frequent when actual food intake was below 25% of calculated~     needs.~      The aim of this international cross-sectional multicentre audit and registry is to generate a~     risk and level of nutritional intervention profile for an individual unit/ward based on~     case-mix, nutrition care and available structures. This profile should give a snapshot on the~     relation of risk to resource allocation. The audit is unit centered. Each unit gets as a~     feedback anonymously its position compared with all other participating units. Risk~     adjustment for selected patient groups, social environments and structures is planned.~      In conclusion this audit/registry will serve five distinct aims:~        -  Generate a precise map of the prevalence of malnutrition before admission and of~          decreased nutrient intake according to risk factors, medical specialty, organisational~          structures and countries.~        -  Increase in awareness for clinical nutrition in patients, caregiver and hospital~          managers.~        -  Enlarge and maintain a reference database for hospitalised patients~        -  Provide individual unit benchmarking~   "
57051|NCT02820233|"~     This study examines the role of the epidermal growth factor (EGF) receptor family and the EGF~     family of ligands in the regulation of non-myocytes isolated from the human heart.~   "
57052|NCT02820220|"~     Observational, cross sectional study, carried out with the help of a pre-designed and~     pre-tested questionnaire with the research hypothesis as: Knowledge and perception regarding~     JSSK and RBSK in nursing students is better as compared to in-service nurses as well as~     patients/patient attendants (attending LHMC and associated hospitals, New Delhi, India)~   "
57053|NCT02820207|"~     OBJECTIVE/BACKGROUND: Intraplaque neovascularization is one of the most important risk~     factors for unstable carotid plaque. This study was designed to evaluate whether carotid~     intraplaque neovascularization (IPN) can be accurately assessed by contrast enhanced~     ultrasound (CEUS).~      METHODS: Preoperative CEUS analysis of 50 carotid artery stenosis patients would be compared~     to histopathology performed on their plaques excised by carotid endarterectomy (CEA) with~     CD34 and MMP9 staining.~   "
57054|NCT02820194|"~     The trial is designed to perform a rigorous evaluation of efficacy and tolerability of SBRT~     by means of a randomised, controlled trial in patients affected by inoperable colorectal~     liver metastases. The chosen comparator is MWA.~      The two modality treatments (SBRT versus MWA) will be evaluated for short- and longer-term~     outcomes.~   "
57055|NCT02820181|"~     Tracheotomy is a common procedure for multiple medical indications.Tracheostomy tubes must be~     securely fixed to prevent movement or decannulation and tracheostomy ties must be exchanged~     as needed. However, the process of ties exchange is always risky and complicated. A novel~     tracheostomy tie has been designed to ensure the safety during exchanging and conveniences of~     cleaning. This study is to determine if the new device is better than the old one.~   "
57056|NCT02820168|"~     The purpose of this study is to create a human-readable and executable computer language to~     implement medical prescriptions and to evaluate and refine this language, with the goal of~     improving safety and efficacy of patient care.~   "
57057|NCT02820155|"~     This is a double-blind, randomized, placebo-controlled, dose-escalating, single dose and~     multiple dose study.~   "
57058|NCT02820142|"~     The incidence of acute kidney injury (AKI) among all hospitalized patients is approximately~     7%. Among these patients, sepsis and septic shock remain the most important cause of acute~     renal failure (ARF) and account for more than 50% of cases of AKI. The goal of this project~     is to uncover key factors that lead to renal function recovery. This study is planned to~     survey novel biomarkers that reflect tissue pathology or regeneration. During the~     hospitalization, blood and urine sample will be collected for NGAL and inflammatory marker~     analysis in the patients with bacteremia, while the rest sample will be collected for further~     novel biomarker survey. This study is to early predict the renal function impairment and~     identify the possible molecule that involved in renal function recovery.~   "
57059|NCT02820129|"~     This study evaluates whether or not the use of a medication wallet card in patients over 70~     taking 5 or more medications promotes self-efficacy with regards to coping with illness,~     understanding medications, and staying healthy. Half of the participants will receive an~     individualized medication wallet card with their medications and medical conditions listed~     while the other half will receive a simple reminder card.~   "
57060|NCT02820116|"~     This is an open-label, multicenter, single-arm, phase II interventional clinical trial~     evaluating efficacy and safety of Icotinib as neoadjuvant treatment in patients with IIIA-~     IIIB NSCLC with activating EGFR mutation in exon 19 or 21. Sixty-seven resectable stage IIIA-~     IIIB NSCLC patients with EGFR activating (19/21) mutations will be eligible to be enrolled.~     EGFR mutation will be prospectively tested in all the participants' biopsy samples and~     confirmed in surgical resected samples.~      Neoadjuvant treatment phase:~      Eligible patients will receive 125mg of Icotinib three times per day. Treatment will be~     scheduled to continue until the disease progression or unbearable toxicities appear.~      Surgery treatment phase:~      Tumor response will be evaluated with CT scan after 8 weeks of induction treatment. The~     patients with responsive disease considered to be technique resectable will undergo~     resection.~      Post-surgery phase:~      It is the discretion of the investigator whether the patient is a candidate for~     post-operative treatment which is considered to be in the best interest of the patients. It~     is recommended that patients with positive margins or residual tumor after surgery should~     receive radiation therapy. Patients after surgery will receive long-term follow-up -- chest~     CT scan，abdominal abdominal ultrasound every 3 months, brain MRI every 6 months, bone scan~     (ECT) every 12 months -- for up to 5 years.~   "
57061|NCT02820103|"~     1. To test the effectiveness of the theory-based interventions (text+visual and text-only~          BCT-based interventions) against usual care in changing patients' intentions to phone~          ambulance immediately with symptoms of ACS ≥ 15 minutes duration.~        2. To determine the most effective mode of delivery by comparing the text+visual BCT-based~          intervention with text-only BCT-based intervention.~        3. To investigate any unintended consequences of the intervention on intentions to phone an~          ambulance for non-life-threatening symptoms.~   "
57062|NCT02820090|"~     Infection and trauma take a important role in the acute respiratory failure.There are~     different causes and degrees of inflammatory reaction in the critically ill patient. The~     inflammatory reaction should also affect patients on mechanical ventilation dependence with~     body physiological response and disease prognosis in patients. Therefore, the investigators~     hypothesize that inflammation may have an important role in the prediction of weaning from~     mechanical ventilation.~   "
57063|NCT02820077|"~     This study evaluates the efficacy of the endoscopic hemostatic powder for the treatment of~     bleeding from malignant lesions of the upper GI tract. Half of participants will receive~     hemostatic powder and half will be submitted to standard treatment.~   "
57064|NCT02820064|"~     Chronic Obstructive Pulmonary Disease (COPD) is characterized by chronic systemic hypoxia and~     low-grade inflammation as well as by an alteration of arginine (ARG) metabolism. As ARG is~     synthetized from circulating citrulline (CIT), an alteration of CIT homeostasis, particularly~     its production by ornithine transcarbamylase (OCT) in small intestine could be involved. We~     hypothesized that hypoxia +/- inflammation, classically associated to COPD, has effects on~     OCT regulation in enterocytes.~      This study aims at exploring the effects of hypoxia and inflammation on the production of~     citrulline by ornithine transcarbamylase (OTC) activity in enterocytes from explant cultures~     of duodenal tissue.~   "
57065|NCT02820051|"~     Flexible bronchoscopy (FB) is a fundamental procedure for the diagnosis and treatment of~     respiratory diseases. Although midazolam is the recommended sedative agent by most~     guidelines, propofol has gained popularity due a short recovery time, however, evidence to~     propofol use for sedation during FB is scarce. There is little evidence about transcutaneous~     CO2 pressure (PtcCO2) behavior among patients sedated with propofol when it is administered~     by non-anesthesiologist and in combination with intravenous opioids for analgesia and cough~     inhibition.~      The investigators performed a randomized controlled trial to determine whether~     non-anesthesiology-administered balanced-sedation with propofol was related to high values of~     values of PtcCO2 compared with guideline-based sedation (midazolam and opioid). The~     investigators included data from outpatients 18 years or older with an indication for FB in a~     university hospital in northern of Mexico. Secondary outcomes were recuperation time, patient~     satisfaction and adverse effects.~   "
57066|NCT02820038|"~     The aim of the proposed project is to compare the effectiveness of two strategies designed to~     enhance patient understanding of medication risks/benefits: (1) Medication Guides, mandated~     for many medications by the Food and Drug Administration and (2) Drug Facts Boxes, developed~     by Woloshin and Schwartz to enhance the usability of consumer medication information. The~     investigators will also assess whether the effectiveness of these communication strategies~     can be increased by Gist Reasoning Training, which is designed to enhance patients' ability~     to extract meaningful gist from complex information.The investigators anticipate enrolling~     300 individuals with rheumatoid arthritis. The study will use a randomized controlled trial~     design with four study arms. Data will be collected primarily via self-administered,~     Internet-based surveys using REDCap. All participants will be followed for 6 months after the~     completion of baseline data collection.~   "
57067|NCT02820025|"~     The current study is designed to investigate the difference of plasma orexin A levels between~     doxapram group and controlled group at emergence time from sevoflurane-remifentanil~     anesthesia who will undergo elective lumbar surgery.~   "
57068|NCT02820012|"~     Although practiced for many years, surgical correction of scoliosis is relatively subject~     published for idiopathic scoliosis and a few published for other types of scoliosis.~      This study involves a creation of an observatory of patients undergoing scoliosis by ST2R~     reduction technique (Simultaneous Translation on Two Rods) associated with the PASS ® system.~      The main objective is to analyze the three-dimensional correction of the deformity after~     intervention and its maintenance over time depending on the etiology of scoliosis.~      This research is conducted in pediatric surgery services specialized in this technique.~      Correcting radiographic parameters is directly related to the surgical procedure. The quality~     of life of patients is indirectly affected by the surgery. Secondary objectives are to~     analyze the surgical technique and to evaluate its impact on the quality of life of patients.~      This study will firstly to have a better understanding in:~        -  Scoliosis of the children and adolescents and their surgical treatment;~        -  The impact of the surgical procedure by the ST2R technique on the three-dimensional~          correction, and the patient's quality of life; and secondly, better management of~          patients requiring surgery for scoliosis as well as a public health impact.~   "
57069|NCT02819999|"~     The purpose of the study is to test the effect of rovalpituzumab tesirine in the frontline~     treatment of small cell lung cancer (SCLC).~   "
57070|NCT02819986|"~     The purpose of the present study is to determine the effectiveness and feasibility of the~     Progressive Goal Attainment Program (PGAP) with individuals with anxiety and mood disorders.~     PGAP has been suggested as an effective therapy to reduce psychosocial barriers and help~     individuals return to life roles including readiness to return to work. PGAP has been shown~     to be effective with some chronic health conditions however has not been specifically studied~     in mental health populations. The study consists of 10 one hour weekly therapy sessions that~     focus on reducing psychosocial risk factors that result in disability through the use of goal~     setting, activity planning and activation, monitoring and challenging thoughts about return~     to work, and problem solving. Participants will also be asked to complete short self-report~     questionnaires as well as a semi-structured interview about the participants anxiety, mood,~     impact of disability, and current functioning at the beginning of session one and within two~     weeks after session 10. Two short questionnaires will also be completed at each session~     measuring the degree to which the participants daily life impacts and is affected by anxiety~     or mood symptoms.~   "
57071|NCT02819973|"~     VIVID is a prospective, multicenter, randomized clinical trial that will evaluate three~     specific research questions. In black patients eligible for a primary prevention implantable~     cardioverter defibrillator (ICD), 1) what is the effect of a patient-centered educational~     video compared with usual care (UC) on knowledge of SCD (Sudden Cardiac Death), associated~     risk factors, and ICDs; 2) what is the effect of a patient-centered educational video~     compared with UC on the decision for ICD implantation, decisional conflict, and receipt of an~     ICD within 90 days of the decision; 3) what is the effect of racial concordance between study~     patients and video participants (health care providers/patients) on the decision for ICD~     implantation, decisional conflict and ICD receipt within 90 days of the decision. In~     addition, in-depth qualitative interviews (IQI) with a sample of trial participants will be~     conducted to determine the salient influences on their decision and explore the reasons for~     their ultimate decision and subsequent implantation or non-implantation of an ICD.~      Approximately 480 patients eligible for a primary prevention ICD will be enrolled at~     approximately 12 hospitals in this study. Study sites selected for VIVID will be~     geographically diverse and provide care to a significant proportion of racial and ethnic~     minority patients. Patient's will be mailed a letter, regarding the study, prior to their~     initial visit. At the initial visit, patients will be approached about participation in the~     trial. For those interested, informed consent will be obtained and patients will be~     randomized. The investigators will be utilizing electronic consents on an iPad. Black~     patients will be randomized to one of 3 arms: educational videos presented in the same~     format; one with black participants (patients and providers) or the other with white~     participants (patients and providers); The third arm will be usual care (control) and the~     provider can interact with the patient consistent with their typical/usual care. Notably, for~     both intervention and control arms, all patient management decisions are completely at the~     discretion of the care providers.~   "
57072|NCT02819960|"~     Diarrhea is a relatively common complication in patients with cancer. At its inception,~     several mechanisms participated; malabsorption on the basis of mucositis induced by~     chemotherapy, dysbiosis induced by broad-spectrum antibiotics and predisposition to~     infectious diarrhea in immunocompromised patients. Some cytostatics and their metabolites can~     also induce diarrhea directly due to effect on the intestinal mucosa.~      Use of probiotics in prevention and treatment of diarrhea relies on both the theoretical~     assumptions and the results of several clinical trials. Lactic acid bacteria involved in the~     treatment of dysbiosis, compete for substrate with pathogenic bacteria, produce~     bacterio-cins, increase transepithelial resistance. Their enzymatic activity affects~     activation or deactivation of metabolites which cause diarrhea. Production of short chain~     fatty acids, which are important for the maintenance of intestinal mucosal cells also~     contributes to their antidiarrhoeal effect.~      This randomized, double-blind, placebo controlled, multicentre trial was designed to evaluate~     potential of probiotics to prevent grade 3-4 diarrhea in patients treated by irinotecan based~     chemotherapy during first 6 weeks of irinotecan based chemotherapy~   "
57073|NCT02819947|"~     To establish a new prospective cohort of Korean patients with systemic sclerosis and track~     the natural history of the disease over time.~      To generate new hypotheses for further investigation.~   "
57074|NCT02819934|"~     A Phase I Study to Investigate the Absorption, Metabolism, and Excretion of KD101 in Male~     Subjects~   "
57075|NCT02819921|"~     This study is a randomized, placebo-controlled study of desvenlafaxine versus placebo. The~     purpose of this study is to determine if desvenlafaxine was effective in decreasing the~     frequency and severity of hot flashes in breast cancer patients taking tamoxifen.~   "
57076|NCT02819908|"~     To compare the relative effectiveness of the Imprimis Dropless™ (TriMoxiVanc) intraocular~     solution with the Less Drops™ topical formulation of PredMoxiKeterolac (given for the first~     week post op) followed by PredKeterolac (given for weeks 2 to 4 after surgery).~      The hypothesis is that the dropless regimen will be non-inferior to the less drops~     regimen in terms of post-operative IOP changes, post-operative healing, and visual quality.~   "
57077|NCT02819895|"~     The purpose of this study is to determine if in a rural setting of Ondo State, Nigeria, a~     customized automated telephone and email immunization reminder system will be feasible,~     acceptable, and significantly improve immunization utilization rates.~   "
57078|NCT02819882|"~     This study is a prospective, multicenter non-interventional cohort study designed to develop~     a registry in unresectable locally advanced or metastatic disease.~   "
57079|NCT02819869|"~     The study demonstrated that either statin or metformin served as notable use in reducing the~     incidence of many cancers.~   "
57080|NCT02819856|"~     The primary objective of this study is to determine the safety and tolerability of SPI-1005~     treatment in CF patients with active pulmonary exacerbation that are receiving an IV course~     of tobramycin, using histories, physical exams, vital signs (VS), adverse event (AE)~     reporting, hematology (CBC) chemistry (Chem-20).~      The secondary objectives of this study are to determine the pharmacokinetics of oral SPI-1005~     at 200, 400 and 600 mg BID for 21 days. Peak/trough assessments will be determined for~     ebselen, its major metabolite and selenium. Clinical assessments of the severity of~     sensorineural hearing loss, speech discrimination, vertigo severity, tinnitus severity and~     lung function will be made compared between treatment arms and the placebo arm of this study.~   "
57081|NCT02819843|"~     The purpose of this phase II clinical study is to test the good and bad effects of T-VEC~     (talimogene laherparepvec) with or without hypofractionated radiotherapy on people with~     melanoma, Merkel cell carcinoma, or other solid tumors with skin metastasis.~   "
57091|NCT02819713|"~     This is a randomized controlled trial. One group (intervention group) will get in advance to~     the prostate biopsy rectal approximately 5 cc Instillagel. And one group (control group) will~     get in advance to the ultrasound -guided prostate biopsy rectal gel. Pain is measured using~     the Numerical Rating Scale (NRS). The NRS is an imaginary line from 0 until 10. The 0 is no~     pain and 10 is most worst imaginable pain.~   "
69583|NCT02656173|"~     The primary objective of the study is to investigate the efficacy of mirabegron versus~     placebo in male patients with OAB symptoms while taking the alpha blocker, tamsulosin, for~     BPH.~   "
57082|NCT02819830|"~     This study is investigating whether a six-week exercise training programme, designed for~     patients with Rheumatoid Arthritis, improves disease activity, inflammation,~     cardiorespiratory fitness, muscle strength, flexibility and risk factors for cardiovascular~     disease. Twenty four patients will be randomly assigned to an intervention or control group~     (n=12 in each group). The intervention group will will undertake a fully supervised~     structured exercise training programme, consisting of both aerobic and strength training~     exercise, taking the form of two 70-minute group fitness classes per week for six weeks.~     These participants will also undertake a 30-minute walk in their own time. The control group~     will continue to go about their normal daily activities. Measurements will be made before and~     after the intervention/control period, including assessments of disease activity (e.g., by~     gauging how swollen and tender patients' joints are using the Disease Activity Score(DAS) )~     and assessments of fitness and/or physical functioning (e.g., 200 meter timed walk test, a~     strength test, a flexibility test, Health Assessment Questionnaire Disability Index (HAQDI)).~     Blood samples will also be collected from patients before and after the intervention/control~     period to measure markers of inflammation, such as C-reactive protein (CRP) and Erythrocyte~     Sedimentation Rate (ESR). The investigators will also measure other parameters that are~     linked to type II diabetes (e.g., fasting glucose concentration) and factors implicated in~     cardiovascular disease risk (e.g., lipid profile and resting blood pressure).~   "
57083|NCT02819817|"~     This is a double blind placebo-controlled RCT comparing the speed of healing of simple~     traumatic wounds with Aloe Vera gel compared to both control (Ultrasound gel) and standard~     care.~   "
57084|NCT02819804|"~     The purpose of this research study is to determine the acceptable upper limit dose of~     nivolumab in combination with dasatinib that may be given to patients with~     relapsed/refractory philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).~     Nivolumab is currently Food and Drug Administration (FDA) approved for other cancers, but has~     not yet been investigated in Ph+ ALL. Dasatinib is currently FDA approved for the treatment~     of Ph+ ALL, but has not yet been investigated in combination with nivolumab for this disease.~     There is evidence that dasatinib not only blocks the Philadelphia chromosome or breakpoint~     cluster region-Abelson murine leukemia viral oncogene homolog 1 (BCR-ABL) mutation, but also~     increases the activity of cells in your immune system. Nivolumab increases T cells in your~     immune system, which allows your immune system to attack the cancer. We think the combination~     of these drugs will be more effective against your leukemia than either drug used alone.~   "
57085|NCT02819791|"~     The Exploration Center for Prevention and Treatment of Atherosclerosis (CEPTA, Bordeaux~     Hospital University) showed that following myocardial infarct (MI) or ischemic stroke (TIA or~     stroke), the global management (medical and educational) of patients led to very long-term~     satisfactory results in terms of reduction of cardiovascular (CV) risk and morbidity and~     mortality. However, the specific effect of therapeutic education beyond the conventional~     treatment has never been an adequate assessment. The following at 1 year of this study will~     show the evolution of chronic long-term CV disease in patients who received therapeutic~     education, and to explain the mechanisms. The challenge of this project is to demonstrate for~     the first time the superiority of therapeutic education and conventional care and propose a~     modeling program for national diffusion.~      Patients who experienced a CV event (MI, stroke) will be randomized into 2 groups of 165~     patients each: 1) receiving conventional treatment alone; 2) receiving conventional treatment~     + CEPTA program. The study was built for a 1-year follow-up period, to demonstrate the impact~     of therapeutic education on evolution of risk factors, physical, psychological and social~     health of patients. The main benefit of this study for the patient is the implementation of~     an optimized treatment and long-term monitoring by a cardiology referral center.~   "
57086|NCT02819778|"~     Mild traumatic brain injury (mTBI) is a very common reason for presentation to pediatric~     emergency departments. So as not to overlook the risk of complications, which occur at a rate~     of 0-7%, measures such as cranial computed tomography (CCT-scan) and/or short inpatient~     observation are prescribed. Ultimately, the majority of these measures could be avoided and a~     large Australian cohort shows that the risk of brain tumors is 2.44 times higher for children~     who had a CCT-scan (3.24 for age 1-4 years). Assay of a sensitive biomarker in blood, such as~     the S100B protein, has the potential to reduce the number of these unnecessary measures.~   "
57087|NCT02819765|"~     This study aims to establish a biorepository and phenotyping database to investigate~     longitudinal changes in ALS subjects. Blood, including DNA and RNA, cerebrospinal fluid (CSF)~     and electrophysiologic measures will be collected every 3 months over 1 year. The database~     and specimen repository will be made available to ALS researchers on a merit basis.~   "
57088|NCT02819752|"~     This study aims to establish whether the combination of pembrolizumab (MK-3475) and~     conventional cisplatin-based chemoradiotherapy is tolerable and results in acceptable levels~     of acute and late toxicity in patients with stage IV LA-SCCHN. In particular, the study will~     provide data on the levels of mucosal and cutaneous toxicity within the radiation fields, as~     these are the primary acute toxicities associated with this treatment regimen. In addition,~     toxicity outside the radiation portals (which may theoretically be exacerbated by radiation)~     will be studied. However, all toxicity will be monitored. This study will also give an~     indication of the activity of pembrolizumab in LA-SCCHN because we are deliberately selecting~     a group of patients with high- and intermediate-risk disease who have a significant chance of~     experiencing loco-regional or systemic failure.~   "
57089|NCT02819739|"~     The hypothesis implies that this work is the use of hyperoxia during cardiopulmonary bypass~     by his heart preconditioning effect is associated with a lower incidence of cardiac~     arrhythmias (atrial fibrillation, tachycardia or ventricular fibrillation) and lesions of~     myocardial ischemia-reperfusion injury in cardiac surgery postoperative.~   "
57090|NCT02819726|"~     This is a randomized, double-blind, parallel group, multicenter study to compare the PK, PD,~     safety, efficacy, tolerability, and immunogenicity of SAIT101 versus MabThera® versus~     Rituxan® in patients with RA. This study will take place globally across approximately 75~     study centers in order to randomize approximately 282 patients. The study consists of Part A~     from baseline for PK and efficacy analysis, followed by Part B from Week 24 to 52 for safety~     follow-up in which collects transition data.~   "
65021|NCT02715882|"~     Randomized Single-blind Placebo-controlled Clinical Study of Safety and Tolerability of~     CBLB502 as a Neo-adjuvant Treatment in Patients With Colorectal Cancer, With Different Doses~     and Regimens~   "
57092|NCT02819700|"~     Behavioural disorders are very common right from the initial stage of dementia and contribute~     to loss of autonomy. Behavioural dysexecutive disorders have a particular status due to their~     prevalence and their diagnostic importance, as they often constitute the initial symptoms of~     Frontotemporal Dementia (FTD), Semantic Dementia (SD) and Huntington's disease (HD) and they~     are classically more frequent in vascular dementia (VaD) than in Alzheimer's disease (AD).~     The presence of these disorders at the stage of Mild Cognitive Impairment (MCI) has only been~     partially evaluated and would increase the risk of progression to dementia. These classical~     data are based on non-standardized assessments and non-validated diagnostic criteria. The~     Groupe de Reflexion pour l'Evaluation des Fonctions EXécutives (GREFEX) has developed a~     standardized assessment tool for behavioural dysexecutive disorders, the Behavioural~     Dysexecutive Syndrome Inventory (BDSI) and has validated diagnostic criteria for this~     syndrome.~   "
57093|NCT02819687|"~     A Phase I, single-center, randomized, double-blind, placebo-controlled study to evaluate the~     safety, tolerability, pharmacokinetics, and pharmacodynamics of single-and multiple-ascending~     doses of RDX5791 in healthy male and female subjects.~   "
57094|NCT02819674|"~     Hypertension (HTN) is the most important cardiovascular risk factor which is responsible for~     50% of cardiovascular morbidity and mortality, and also a substantial public health problem~     affecting approximately 1/4 of the adult population in industrialized societies and over 1~     billion people worldwide. Chronically elevated blood pressure without well control puts~     people at increased risk of target organ damages, including stroke, myocardial infarction,~     congestive heart failure, end-stage renal disease, blindness, and death. Especially, these~     damages are dramatically more severe in the early-onset hypertensive population.~   "
57095|NCT02819661|"~     The study will examine whether there is a difference in the frequencies of respiratory~     depression among obese women receiving spinal anesthesia combined with opioids compared to~     women with normal BMI.~      If such a risk exists further investigation will be required to establish the proper criteria~     for the administration of morphine with spinal anesthesia to obese women.~   "
57096|NCT02819648|"~     The aim of this single-center randomized, double-blind, placebo-controlled clinical trial is~     to assess the effect of preoperative, single, oral dose of prednisolone on postoperative pain~     and medication intake in patients with symptomatic, irreversible pulpitis in mandibular~     molars.~   "
57097|NCT02819635|"~     This study comprises three sub-studies. The objective of sub-study 1 is to characterize the~     dose-response, efficacy, and safety of ABT-494 compared to placebo in inducing clinical~     remission in order to identify the induction dose of ABT-494 for further evaluation in~     sub-study 2. The objective of sub-study 2 is to evaluate the efficacy and safety of ABT-494~     compared to placebo in inducing clinical remission in participants. The objective of~     sub-study 3 is to evaluate the efficacy and safety of ABT-494 compared to placebo in~     achieving clinical remission in participants who had a response following induction with~     ABT-494.~   "
57098|NCT02819622|"~     Purpose: Central serous retinopathy (CSCR) is characterized by macular detachment due to~     thickened choroid mostly affecting young men under perceived stress. While most previous~     studies in CSCR have been retrospective and have focused on a single facet of the patient's~     personality, the investigators conducted a prospective intercontinental controlled study to~     analyze the multifaceted personality profile in CSCR.~      Design: Prospective interview. Participants and Controls: Subjects with CSCR consented to~     participate in a questionnaire. Controls not having retinal disease were recruited from the~     same clinic.~      Main Outcome Measures: The main parameters registered were presence of stress, daily number~     of cups caffeine intake, personality traits (Type A; obsessive-compulsive; aggressive).~      Methods: The interview consisted of a 60-item questionnaire. Recruitment of participants was~     from January 2015 to February 2016. Controls were matched for age, gender and race.~     Statistical analyses were done using univariate and multivariate analysis.~   "
57099|NCT02819609|"~     The purpose of this observational, retrospective database study of patients with uterine~     fibroids is to compare the durability of symptom relief after uterus-conserving treatments~     for symptomatic fibroids in terms of incidence of, and time to, new or recurrent symptoms and~     subsequent procedures and evaluate the effect stakeholder participation had on the research~     process.~   "
57100|NCT02819596|"~     This study is being carried out to see if the drugs MEDI4736, Savolitinib and Tremelimumab~     can be used alone or in combination to reduce the size of tumours in patients with kidney~     cancer.~      The drugs being tested in this study have an anti-tumour effect and have been tested in~     pre-clinical and human studies before. MEDI4736 and tremelimumab work with the immune system~     to help the body fight against tumour cells with immune cells. Savolitinib works to correct a~     faulty signal which causes tumour growth.~      If a patient is eligible for the study and decides to take part, they will be enrolled into~     one of 3 stages of the study.~        -  First stage [CLOSED TO RECRUITMENT]: aims to find the optimal dose of~          MEDI4736+savolitinib.~        -  Second stage [RECRUITING]: patients with papillary cell cancer will be treated with~          MEDI4736+savolitinib. Patients with clear cell cancer will be randomised to one of four~          treatment arms and receive MEDI4736, savolitinib, MEDI4736+savolitinib, or~          MEDI4736+tremelimumab.~        -  Third stage [NOT YET OPEN TO RECRUITMENT]: patients will be tested for biomarkers before~          enrolment, and depending on the results will be allocated to one of 3 treatments~          (MEDI4736, savolitinib, or MEDI4736+tremelimumab) to see if certain biomarkers are~          linked to drug efficacy.~   "
57101|NCT02819583|"~     The purpose of this study is to evaluate the safety and effectiveness of CAR-T cell~     immunotherapy in patients with CD19 positive relapsed or refractory Leukemia and Lymphoma.~   "
57102|NCT02819570|"~     The objective of the study is to compare a new antibiotic protocol with the current~     prophylactic treatment in routine use and to evaluate obstetric and neonatal outcome: preterm~     labor, chorioamnionitis and early onset sepsis~   "
57103|NCT02819557|"~     This is a Phase 2, multiple-dose, open-label study evaluating the safety, and~     pharmacokinetics (PK) of ataluren in patients aged ≥2 to <5 years old with Duchenne muscular~     dystrophy caused by a nonsense mutation in the dystrophin gene. The study includes a 4-week~     screening period, a 4-week study period, and a 48-week extension period for patients who~     complete the 4-week study period (52 weeks total treatment).~   "
57104|NCT02819544|"~     Known to reduce analgesics and length of hospitalization in conventional surgery, laparoscopy~     is characterized by frequent post-operative pain and can decrease the patient's quality of~     immediate postoperative life and sometimes the results of decision ambulatory care.~      In order to reduce these postoperative pain, various methods have been evaluated in numerous~     studies to determine their analgesic role.~      As part of abdominal surgery, local anesthetics (Naropin (Ropivacaine)) are generally~     administered in the end of surgery to reduce postoperative pain and promote recovery of the~     patient. In addition, it is also possible to instill the anesthetic directly into the~     abdominal cavity reducing pain transmitted by nociceptor viscera.~      In recent years, new methods have been proposed such as lung recruitment maneuvers and the~     instillation of saline solution to reduce postoperative pain.~      However, no recommendation is on the use of intraperitoneal saline under the management of~     postoperative pain after laparoscopic cholecystectomy in ambulatory care.~   "
57105|NCT02819531|"~     Design: The proposed study is a randomized study comparing the relative effectiveness of~     three lesion modification strategies (RA, SBS, or OAS) in the treatment of obstructive CCLs~     using the change in lumen size measurements (MLA, RLA, MSA and the ratio of MSA/MLA) obtained~     with IVUS or OCT. Patients will be blinded to treatment assignment for the duration of the~     study.~      Treatment: Patients who are randomized to RA will undergo coronary wiring of the CCL and~     subsequent advancement of the RA burr. The RA system is performed using standard technique~     under intravenous infusion of heparin. The atherectomy burr size will be determined by the~     operator.~      Patients who are randomized to OAS will undergo coronary wiring of the CCL and subsequent~     advancement of the OAS according to the manufacturer's guidelines.~      Control: Patients who are randomized to SBS will undergo coronary wiring and balloon~     inflation with SBS performed by standard technique under intravenous infusion of heparin. SBS~     will be used according to the AngioSculpt manufacturer's guidelines.~      Duration: 30 days follow-up.~      The primary trial objective is to determine which of the three treatment strategies for~     treating calcified coronary lesions (RA, SBS, or OA) is superior for obtaining higher ratio~     of final in-stent minimum lumen area/reference lumen area, as determined by IVUS or OCT~     (primary study endpoint).~      The secondary objectives are to compare the following:~        1. Difference in pre- vs. post-treatment minimum lumen area (MLA, lumen area gain), as~          determined by IVUS or OCT (secondary endpoint)~        2. Mean final minimal stent area (MSA), as assessed by IVUS or OCT (secondary endpoint)~        3. Ratio of final in-stent minimum lumen diameter/reference lumen diameter, as determined~          by quantitative coronary angiography (secondary endpoint)~        4. Incidence of major adverse cardiac events (death, myocardial infarction, target vessel~          revascularization) during 30 days of follow-up (secondary endpoints)~        5. Procedure time, fluoroscopy time, and contrast volume (secondary endpoints)~   "
57106|NCT02819518|"~     The study will consist of two parts. In Part 1, the safety of pembrolizumab (MK-3475) in~     combination with one of three different chemotherapies will be assessed in the treatment of~     locally recurrent inoperable or metastatic triple negative breast cancer (TNBC), which has~     not been previously treated with chemotherapy. In Part 2, the safety and efficacy of~     pembrolizumab plus chemotherapy will be assessed compared to the safety and efficacy of~     placebo plus chemotherapy in the treatment of locally recurrent inoperable or metastatic~     TNBC, which has not been previously treated with chemotherapy.~      The primary hypotheses are that the combination of pembrolizumab and chemotherapy prolongs~     Progression-Free Survival (PFS) compared to placebo and chemotherapy in all participants and~     in participants with programmed cell death ligand 1 (PD-L1) positive tumors, and prolongs~     Overall Survival (OS) compared to placebo and chemotherapy in all participants and in~     participants with PD-L1 positive tumors.~   "
57107|NCT02819505|"~     Carnosine (made by bonding β-alanine and histidine) has been suggested to contribute to the~     extension of physical exercise, counteracting the decline in muscle performance due to~     fatigue. However this process is largely restricted by the levels of β-alanine available in~     the human body. Carnosine levels can be raised through long term ingestion of food products,~     such as meat, fish and poultry, however it can also be significantly increased by β-alanine~     supplementation. Improved β-alanine levels can potentially advance exercise capacity and~     exercise performance, which may have been previously limited. Recently research has~     demonstrated no beneficial effect of β-alanine supplementation on neuromuscular performance~     in active, healthy males when they were well rested, with no prior exercise or fatigue of the~     assessed muscle. It remains unknown if β-alanine supplementation would aid physical~     performance when the muscle has already been fatigued. This is currently being investigated~     in older adults (60-80 years), however there is no clear comparison between the potential~     effects in younger and older participants.~      Therefore this investigation hopes to examine the effects of 4 week β-alanine supplementation~     on lower limb contractile and force properties, pre and post muscle specific fatigue in 18-30~     year old males.~   "
57108|NCT02819492|"~     Adenoma detection in the main goal of screening colonoscopy. In order to detect adenomas it~     is mandatory to spend a long enough time investigating the colonic mucosa. A minimum~     observation time of 6 minutes has been proposed as a quality criterion for screening~     colonoscopy. However, different locations of the colon (proximal, distal) may require~     specific observation time periods. The colon can be divided into a proximal (right) and~     distal (left) part. Until now, it is unclear whether observation time has a significant~     impact on adenoma detection in both parts of the colon. The aim of this study therefore is to~     conduct a trial in which side-specific observation times and adenoma detection rates are~     measured in order to investigate this correlation in particular for the right colon.~   "
57109|NCT02819479|"~     To assess the overall safety and efficacy of intra-arterial (IA) bevacizumab for the~     treatment of radiation necrosis. A single 2.5 mg/kg dose of bevacizumab will be given~     intra-arterially after osmotic blood-brain-barrier disruption.~   "
57110|NCT02819466|"~     Aspiration pneumonia is a dreaded complication of anaesthesia because of its prevalence~     (1/3,886 cases in elective anaesthesia and 1/895 cases in emergency settings) and its high~     morbidity and mortality (3 to 9%). This chemical and/or infectious pneumonia is secondary to~     passage of the gastric contents into the unprotected upper airways during general~     anaesthesia. The prognosis depends on three factors: the presence of food debris, and the~     acidity and volume of the gastric contents. To prevent this complication, the French society~     of anaesthesia and intensive care recommends preoperative fasting rules and, in patients~     presenting risk factors for aspiration, the use of antacids and rapid sequence intubation.~     This preventive strategy is associated with certain adverse events: deferred operative~     procedures, discomfort and hypoglycaemia secondary to fasting, more frequent anaphylactic~     complications, and memory of anaesthetic induction.~      Over recent years, ultrasound has become more widely used by anaesthetists for local~     anaesthesia, vascular catheterization, haemodynamic monitoring and, more recently, 2D~     ultrasound estimation of intragastric volume. However, 2D ultrasound estimation of~     intragastric volume presents several limitations: because of the complex shape of the~     stomach, this technique requires a long learning curve and the measured volume is poorly~     correlated with reference techniques (MRI and 99Tc scintigraphy). Two studies have recently~     measured intragastric volume by three dimensional ultrasound with promising results.~   "
57111|NCT02819453|"~     It is acknowledged that IL-18, as a product of the inflammasome, is involved in host defence~     against viral and bacterial stimuli by modulating the immune response. The aim of this study~     was to determine IL-18 levels in serum of patients with acute respiratory distress syndrome~     and to investigate whether corticosteroid attenuate its levels.~   "
57112|NCT02819440|"~     Obesity and its adverse cardiometabolic consequences are major public health problems.~     Several features of obesity contribute to the associated cardiovascular risk and are~     potential targets for intervention. These include insulin resistance and beta cell~     dysfunction, reduced metabolic rate, and impaired aerobic capacity.The purpose of this study~     is to examine if the phosphodiesterase type 5A inhibitor tadalafil improves cardiometabolic~     health in individuals who are obese and insulin resistant.~   "
57113|NCT02819427|"~     This study, conducted in children with typical or atypical absence epilepsy, will consist~     of noninvasive recording of the metabolic activity of the brain concomitantly with~     electroencephalographic recording during seizures without the need for any additional~     examination. This examination will be performed by combining near-infrared spectroscopy~     (NIRS) optical imaging and Electroencephalography (EEG) in a simultaneous High-Resolution~     (HR) recording.~      Surface electroencephalography (EEG) is a valuable tool to assess neuronal dysfunction from a~     functional point of view and is used in the routine follow-up of epileptic children. Optical~     imaging is a recent and promising medical imaging technique, which uses near-infrared light.~     This rapid, noninvasive and harmless quantitative technique can be easily used at the child's~     bedside or in the ward and provides metabolic information on brain functioning.~   "
57114|NCT02819414|"~     The therapeutic approach to the patent ductus arteriosus (PDA) in the premature neonate~     remains controversial. Currently it is generally accepted to treat only hemodynamically~     significant PDAs. The current investigation aims to study the effect of treatment on PDAs of~     borderline significance via a prospective, randomized controlled trial of paracetamol in this~     group.~   "
57115|NCT02819401|"~     The present study is designed to determine the gastrointestinal tolerability of enteral~     nutritional products, physicians and parents' overall perception of enteral nutrition~     products as well as providing basic demographic information on pediatric populations~     prescribed these formula for supportive treatment as part of the routine healthcare service~     in Turkey.~   "
57116|NCT02819388|"~     This study evaluates the effects of a community-based counseling intervention to improve~     contraception among residents in two deprived neighborhoods in Barcelona (Spain). Half of the~     participants received contraceptive counseling at the community setting, while the other half~     acted as a control group.~   "
57117|NCT02819375|"~     Electroconvulsive therapy (ECT) is a common treatment method used in severe depression and~     other psychiatric diseases. Currently, most ECT procedures are carried out with muscle~     paralysis under general anaesthesia. The anticonvulsant properties of sedative and hypnotic~     drugs used during general anaesthesia may reduce the efficacy of ECT. It is important to~     establish an accurate balance between adequate anaesthesia depth and optimal seizure~     duration.~      We aimed to compare the effectiveness of three anaesthetic regimens (propofol alone, propofol~     with remifentanil and propofol with ketamine), with respect to seizure duration and seizure~     quality in patients undergoing electroconvulsive therapy.~   "
57118|NCT02819362|"~     Benefit of MRI in pathological nipple discharge.~   "
57119|NCT02819349|"~     The purpose of this study is to examine whether Texting for Relapse Prevention (T4RP), a text~     messaging-based early warming for relapse prevention in people who have schizophrenia/SAD, is~     associated with fewer relapse symptoms compared to a treatment-as-usual control group.~   "
57120|NCT02819336|"~     This pilot protocol is aimed to evaluate the effectiveness and safety of electroacupuncture~     therapy for the post-stroke patients with urinary incontinence.~   "
57121|NCT02819323|"~     The objective of this study is to compare the safety, tolerance and efficacy of BLI800 to a~     PEG based preparation prior to colonoscopy in adolescent patients.~   "
57122|NCT02819310|"~     The objective of this study is to evaluate the safety of chronic use of BLI400 laxative in~     constipated adults.~   "
57123|NCT02819297|"~     The objective of this study is to evaluate a daily dose of BLI400 Laxative for safety and~     efficacy versus placebo in constipated adults.~   "
57124|NCT02819284|"~     The primary purpose of this study is to determine the efficacy and safety of KPI-121 0.25%~     ophthalmic suspension compared to vehicle (placebo) in subjects who have a documented~     clinical diagnosis of dry eye disease. The product will be studied over 14 days, with 1-2~     drops instilled in each eye four times daily (QID).~   "
57125|NCT02819271|"~     This study is designed to assess a safe dosage of the drug CXL-1427 (BMS-986231) in healthy~     volunteers.~   "
57126|NCT02819258|"~     Endodontic therapy is to achieve the eviction of the inflamed or infected pulp and fill the~     canal opening with a hermetic sealing material.~      The analysis of the literature on intracanal therapeutic shows great variability of the~     results obtained, the reported success rate is 53 to 95%.~      This is explained by the difficulty of the surgical procedure, but also by the multiplicity~     of possible factors of failure, related practitioner, canal anatomy, the operating~     procedures, the preparation techniques and root canal filling. This success rate is variable~     depending on the presence or absence of periapical pathology before treatment: more than 85%~     for teeth treated without initial periapical pathology against only 62% for teeth with~     pathology before treatment. Furthermore, the literature review revealed two contradictory~     assumptions about the dominant factor failure in endodontics: the failure of the sealing~     canal system (bad level shutter) against the failure of the endovascular disinfection.~      Main hypothesis of the research objectives:~      The probability of success in a year endodontic treatments carried out according to the~     recommendations and the operating standards on teeth with periapical pathology is~     approximately 60%.~      The primary prognostic factors would be the existence of intracanal obstacles (stop~     calcification ...) responsible for a sub-obturation of the canal, factors inherent to the~     tooth (situation ductal anatomy and complexity), the operating techniques used, the~     practitioner ( skill level), the quality of the restoration.~   "
57127|NCT02819245|"~     This is a study prospectively enrolling adolescent idiopathic scoliosis (AIS) patients and~     try to find how the age will impact the surgical outcome of AIS.~   "
57128|NCT02819232|"~     Infectious keratitis are favored by the circumstances causing the small trauma of the corneal~     epithelium, corneal surgery, corneal dryness under health system such as Sjögren's syndrome~     rheumatoid arthritis, or much more frequently wearing contact lenses. If the majority of~     infectious keratitis are favourable, some lead to serious injury of the cornea, or even~     corneal perforation which result an endophthalmitis. This unfavourable evolution may lead to~     blindness due to corneal damage, the endo-ocular lesions or enucleation of the eyeball. This~     negative evolution is encountered while the infectious keratitis due to tedious germs of~     difficult diagnosis such as nontuberculous Mycobacterial, fungal infections, fungal~     keratitis, amoebic keratitis, and certain viral keratitis. The microbiological diagnosis of~     routine is based on the systematic search for pathogens tedious from invasive sampling of~     cornea by vaccinostyle. We set up a new non-invasive corneal swab diagnostic method.~   "
57129|NCT02819219|"~     This study will examine the effects of supplemental ElevATP with or without a blend of~     extended-release caffeine and B vitamins for changes in body composition, athletic~     performance, and hematology over a 12 week intervention period.~   "
57130|NCT02819206|"~     Our research project is to use a new microbiological diagnostic strategy of uveitis, allowing~     detection of the fastidious pathogens of infectious Uveitis who are not diagnosed by~     laboratory methods used in diagnostic routine. This new diagnostic strategy is to~     automatically detect the presence of a pathogen fastidious in cell culture using the same~     patient's serum to reveal a positive culture, based on the assumption that this serum~     contains antibodies specific pathogen tedious.~      Finally, the main purpose of this study is to improve the etiological diagnosis of Uveitis by~     establishing a new diagnostic strategy.~   "
57131|NCT02819193|"~     Despite the importance of breast milk for sick or preterm neonates, there is currently no~     consensus regarding the use of raw mother's own milk (MOM) in neonatal units. The aims of~     this study are to: (a) describe factors associated with the use of raw MOM; (b) investigate~     the association between early use of raw MOM and breastfeeding continuation at discharge and~     up to 6 months later.~   "
57132|NCT02819180|"~     Prospective cohort study to evaluate the safety and immunogenicity of the Butantan Influenza~     vaccine (Fragmented and Inactivated) among healthy adults with 18 to 59 years of age and~     elderly older than 60 years of age.~   "
57133|NCT02819167|"~     Ischemic strokes are one of the leading causes of handicap and death in elderly people in~     France.~      Cognitive reserve (CR) is an active model, defined as a function of lifetime intellectual~     activities and other environmental factors that explain differential susceptibility to~     functional impairment in the presence of pathology or other neurological insult. CR is~     estimated using variables for cognitive activity: years of education, professional status,~     socioeconomic status… Furthermore, brain reverse (BR) is a passive and quantitative model~     that depend on brain size and other quantitative aspects of the brain that explain~     differential susceptibility to functional impairment in the presence of pathology.~      Firstly, volume and localization of ischemic strokes have a great impact on CR and BR due to~     brain injury. On the other hand, CR influences the severity and the expression of cognitive~     diseases.~      The investigators realize a prospective study in order to assess the impact of CR and BR on~     cognitive prognosis after a right middle cerebral artery ischemic stroke in elderly patients.~   "
57134|NCT02819154|"~     Patients are admitted to intensive care for serious diseases (sepsis, ARDS ...) burdened with~     a high mortality rate. Invasive methods of resuscitation and the diseases treated can lead to~     serious sequelae. Follow-up studies of patients at hospital discharge report most often the~     quality of life using validated quantitative scales. A recent consensus of the American~     Society of resuscitation an update on the physical, cognitive and psychological sequelae of~     ICU hospitalization for the family and the patient, grouped under the term post-intensive~     care syndrome. Social changes, emotional and professional are little studied and are not~     part of the information provided by the quality of life questionnaires. The investigators~     hypothesize that intensive care stay entails a profound effect on the lives of patients. This~     study will add additional data on a little known aspect of post resuscitation.~   "
57135|NCT02819141|"~     The purpose of this randomized clinical trial is to test the efficacy of dexmedetomidine for~     the self-management of sedative therapy (SMST) in a sample of critically ill patients~     receiving mechanical ventilator support. The investigators hypothesis is that self-management~     of sedative therapy by mechanically ventilated patients in the intensive care unit (ICU),~     tailored to their individual needs will be more efficacious than nurse-administered sedative~     therapy in reducing anxiety, which may reduce duration of mechanical ventilator support and~     occurrence of delirium.~   "
57136|NCT02819128|"~     Hypothesis:~      Homeless people have infections not diagnosed with a potential impact on their health status.~      Main Purpose: Improve the etiological diagnosis of endemic and/or emerging pathologies among~     homeless people.~   "
57137|NCT02819115|"~     Prospective study to evaluate the safety and immunogenicity of Butantan Influenza seasonal~     vaccine.~   "
57138|NCT02819102|"~     This is an open-label, single sequence study to evaluate the effect of BCX7353 on hepatic and~     intestinal cytochrome P450 enzymes using probe substrate drugs in healthy subjects.~     Pharmacokinetics of the probe substrate drugs will be measured prior to and following~     administration of multiple doses of BCX7353.~   "
57139|NCT02819089|"~     The purpose of this study is to determine the recovery profiles after general anesthesia in~     patient undergoing anterior cervical spine surgery. This study will compare the Riker~     sedation agitation scores between two groups, with or without dexmedetomidine as an~     anesthetic adjuvant.~   "
57152|NCT02818907|"~     This study aims to collect clinical, biological and quality of life data from patients with a~     borderline or resectable pancreatic cancer. It will collect information from the date of~     diagnosis along the therapeutic care of the patients, and a 3-years follow-up after the end~     of the treatment. The database will be updated at each patient's visit. Biological samples~     will include: tumor, and plasma. Epidemiological data will also be collected, whereas Quality~     of life will be assessed by the EORTC standard. The objectives of this database are to~     identify new biomarkers (genomic, immunologic, and epidemiologic) and promote high quality~     standard research protocol.~   "
58197|NCT02805127|"~     This is an observational study which aims to evaluate the possibility of using data from a~     capnography device to assess obstructive airway severity in both Chronic Obstructive~     Pulmonary Disease (COPD) and Asthma patients.~   "
57140|NCT02819076|"~     Maternity and neonatology, caregivers are regularly confronted with the pain of the newborn,~     especially after a birth injury, but it is sometimes difficult ti define.~      There is not, to our knowledge, any prevalence study of pain in newborn motherhood. The data~     available are those of the perinatal survey 2010, with the number of operative vaginal~     deliveries (5.3% of suction, forceps 3.9%, 2.9% spatulas) and the number of extractions the~     seat (4.7%). These delivery modes can be purveyors of pain.~      At St. Joseph's Hospital, there were in 2013: 259 instrumental deliveries and 90 extractions~     by headquarters. Fifty five paracetamol bottles were consumed in the layer sequence in 2013,~     and 15 in the delivery room. But this consumption is a poor reflection of the pain because~     treatment could be given pain-authenticated (measured with the EDIN scale), and because a~     bottle is discarded one month after opening.~      The scales measuring pain used in the new-born at term based on the assessment of change in~     behavior; two specific scores of the newborn are used in France: Pain and Discomfort Scale~     Newborn (EDIN) for prolonged pain and Acute Pain scale Newborn (DAN) for acute pain related~     to health care.~      The EVENDOL scale (Child Pain Evaluation) has been validated for pediatric emergencies in~     children 0-7 years, as well as pre-hospital, to measure the intensity of pain whether acute~     or prolonged (8 ). It is easy and fast to use. validation cohorts included a significant~     proportion of newborns. This scale appears suitable for evaluation of the newborn to term~     maternity~   "
57141|NCT02819050|"~     Though Nasal Continuous Positive Airway Pressure (NCPAP) is a commonly used form of~     non-invasive neonatal respiratory support, the optimal method of weaning off NCPAP is not~     well established. In this prospective, two-center randomized control trial we hypothesize~     that gradually increasing time off NCPAP (sprinting) increases the success of weaning NCPAP~     off in infants born between 23 0/7-30 6/7 weeks of gestational age.~   "
57142|NCT02819037|"~     The objective of this research is to determine the incidence of microbial overgrowth of the~     small intestine before and after a gastric bypass. For this purpose, the study is based on~     the analysis of the expired hydrogen H2 with gas chromatography before surgery and at 1, 3,~     6, 12, 18 and 24 months.~   "
57143|NCT02819024|"~     This pilot research trial studies the effects of dexamethasone in patients with non-small~     cell lung cancer that has not responded after previous treatment. Drugs such as dexamethasone~     can affect how tumors grow and respond to treatments. Imaging tests, such as~     fluoro-L-thymidine (FLT) positron emission tomography , use a small amount of radioactive~     substance to show changes in tumor cells. Studying the effects of dexamethasone on lung~     tumors using FLT positron emission tomography may help doctors plan better treatments.~   "
57144|NCT02819011|"~     The investigators propose a randomized control trial to evaluate long term effects and~     effectiveness of Moore Balance Brace (MBB) ankle foot orthoses (AFO) in reducing risk of~     falling in older adults.~      Primary Endpoints • Characterize the impact of MBB AFO on balance, gait, risk of falling,~     frailty status, and adverse events~      Secondary Endpoints • Characterize the Impact of MBB AFO on spontaneous daily physical~     activities • Characterize the feasibility of the MBB AFO device on patient adherence,~     acceptability, user-friendliness, and perception of benefit for daily usage~   "
57145|NCT02818998|"~     To evaluate the efficacy of long-term treatment with 2 mg aflibercept via different~     intravitreal (IVT) treatment regimens to subjects with DME pretreated with 2 mg aflibercept~     every 8 weeks after 5 initial monthly injections for approximately 1 year or more (according~     to the EU label for the first year of treatment)~   "
57146|NCT02818985|"~     Pain relief in knee Arthroscopic Surgery is essential for rapid recovery of function.~   "
57147|NCT02818972|"~     Investigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts in subjects~     with thoracic aortic aneurysms (TAA) and penetrating atherosclerotic ulcers (PAU) of the~     descending thoracic aorta.~   "
57148|NCT02818959|"~     The objective of this study is to evaluate feasibility, safety and effectiveness of the first~     generation transfemoral JenaValve Pericardial TAVR System (formerly named JenaValve TAVI Plus~     System- Transfemoral) in an elderly patient population with severe aortic stenosis who are at~     high risk for surgical aortic valve replacement.~   "
57149|NCT02818946|"~     The purpose of the proposed prospective study is to determine the diagnostic value of MRI for~     the evaluation of patients with pathologic nipple discharge. Breast surgeons will identify~     clinic patients with pathologic nipple discharge (unilateral and bloody or unilateral and~     clear) and refer them for breast MRI. When the clinical team notifies the study team that an~     MRI has been ordered for that purpose, the study team will consent patients to document the~     results and follow-up. The study team will not be obtaining MRI's on patients for research~     purposes only. The following data will be collected and analyzed: patient age,~     characteristics of the discharge (laterality, spontaneous versus expressed, duration of time,~     color, presence of blood), imaging workup and findings, BI-RADS final assessment categories,~     pathology results from core biopsy and/or surgical excision, and clinical and radiologic~     follow-up data during the two years after presentation. Participation in this study poses~     minimal risk to patients. Risks to the subjects include loss of confidentiality and~     unnecessary breast biopsy. The risks associated with MRI are minimal; however, since a~     gadolinium-based contrast agent will be administered for the MRI, patients with compromised~     renal function and patients who are pregnant will be excluded from the study.~   "
57150|NCT02818933|"~     The purpose of this pilot study is to assess the quality of self-report data obtained using~     the Automated Self Administered 24-Hour Recall (ASA24-Kids-2014) relative to an interviewer~     administered 24-hour recall in a sample of adolescents ages 12-17 years, to determine their~     method preference, and to assess issues related to each method.~   "
57151|NCT02818920|"~     This multi-institutional, phase 2 clinical trial is studying two doses of pembrolizumab~     administered prior to surgery (neoadjuvant therapy) and 4 doses administered after surgery~     (adjuvant therapy) for stage IB, II or IIIA non-small cell lung cancer. Pembrolizumab is a~     type of immunotherapy that may enhance the ability of the immune system to fight off cancer.~     The study will investigate the effects of pembrolizumab on the immune system and how certain~     immune cells, called TILs (tumor infiltrating lymphocytes), respond to pembrolizumab.~     Previous studies suggest that pembrolizumab could alter the immune cells in a way that the~     the immune cells identify cancer cells. Pembrolizumab has been approved for the treatment of~     advanced lung cancer, but is investigational in this setting.~   "
57153|NCT02818894|"~     Spinal anesthesia is commonly used in patients undergoing total hip replacements. The purpose~     of this study is to compare lidocaine to bupivacaine spinal anesthesia in patients having a~     total hip arthroplasty (THA). The objective of this study is to compare the two spinal~     anesthesia treatments in regards to transient neurological symptoms (TNS).~   "
57154|NCT02818881|"~     This study examined the muscle activity, movement patterns, and oxygen consumption during a~     series of yoga poses with slow and rapid transitions.~   "
57155|NCT02818868|"~     The aim of this study is to investigate the clinical events of the patients with acute~     cerebral large vessel occlusion or stenosis and atrial fibrillation, treated by apixaban~     within 14 days after onset. This is the observational study that patients will be made the~     registration at the timing of both retrospective period and prospective period.~   "
57156|NCT02818855|"~     Gingival recession (GR) is frequently associated with deterioration in dental esthetics and~     dental hypersensitivity. Outcomes from recent systematic reviews have demonstrated that when~     the root is covered and the gain in the width of keratinized tissue (KT) is expected, the use~     of subepithelial connective tissue grafts (SCTGs) associated with coronally advanced flaps~     (CAF) appears to be more predictable, and may be considered the gold standard procedure.~     However, the SCTGs may increase patients' morbidity (e.g., pain). This occurs because of the~     need for a donor surgical area, which may increase the risk of surgical complications like~     bleeding, as well as increases post-operative discomfort and the period of the surgical~     procedure. Another biomaterial, a new collagen matrix (CM) has been used as a substitute for~     the SCTG. The use of CM was associated with a significant reduction in post-operative~     morbidity, less post-operative pain and discomfort in the patient, and more esthetic~     satisfaction.~   "
57157|NCT02818842|"~     Medication during pregnancy can lead to the occurrence of birth defects or neonatal~     pathologies. Thalidomide or diethylstilbestrol (Distilbene°) are prominent examples. Many~     drugs remain insufficiently evaluated in this area and doctors are too often deprived of~     relevant information when prescribing drugs in pregnant women.~   "
57158|NCT02818829|"~     BACAP is a biobank dedicated to the pancreatic adenocarcinoma funded by institut national~     institue du cancer (INCa) and coordinated by Dr Barbara Bournet from Toulouse hospital. This~     base includes clinical data and biological samples such as blood, serum, plasma, saliva, DNA~     and RNA from tumors cells.~      The mission of this prospective project is to make available to the scientific community a~     clinical biological base from patients with pancreatic adenocarcinoma~   "
57159|NCT02818816|"~     Patients with prostate cancer undergoing robot assisted radical laparoscopic prostatectomy~     (RALP) in steep Trendelenburg position (sTBURG) are noted to have elevated intraocular~     pressures (IOP) intraoperatively. One study showed an increase in IOP of 13 millimeters of~     mercury (mmHg) from baseline IOP levels intraoperatively. Other studies have shown the IOP to~     more than double intraoperatively during RALP in sTBURG. IOP is found to be directly related~     to angle of inclination and increases time dependently with sTBURG. The IOP may remain~     significantly elevated until the first postoperative day after RALP.~      There are no previously published data concerning the safe threshold for IOP elevation and~     the effects of this increased IOP on vision and on generalized eye health are still not~     entirely known. One study showed postoperative visual field defects in 28% (7/25) of patients~     who underwent RALP in sTBURG. It has been theorized that sTBURG and subsequent increased IOP~     are risk factors for postoperative vision loss (PVL). It is believed that the increased IOP~     decreases optic nerve perfusion pressure causing ischemic optic neuropathy. Some previously~     recommended ways to reduce the intraoperative IOP spike during RALP include shorter operating~     times, decreased angle of inclination, modified Trendelenburg position, use of Propofol for~     maintenance anaesthesia and intraoperative topical hypotensive agents to reduce IOP. Given~     the challenges with some of the above options, this study aims to evaluate the effect of~     pre-operative treatment with topical Brimonidine Tartrate 0.2% on the IOP of patients~     undergoing RALP with sTBURG. The goal is to prevent the anticipated IOP spike thereby~     reducing risk of postoperative vision loss.~   "
57160|NCT02818803|"~     The purpose of this study is to evaluate the efficacy and safety of propolis on the treatment~     of oral candidiasis, more specifically denture stomatitis. Half of participants will receive~     a standardized-propolis (EPP-AF®) gel formulation while the other half will receive~     miconazole gel, both for oral use.~   "
57161|NCT02818790|"~     The goal of the MI field test is to assess users' overall satisfaction, usability and~     acceptability of the PRECIOUS system, and to explore if MI in combination with gamification~     principles is a feasible solution to foster adherence to PRECIOUS system. Moreover, it is~     pursued to trigger behavior change and build up motivation to maintain sustained change~     towards healthy lifestyles. The field test at University Hospital Vall d'Hebron will be~     carried out with morbidly obese pre-diabetic patients. This pilot test will serve to explore~     users' acceptance of PRECIOUS system in an early stage of its development. Considering that~     this is a pilot test, feedback and outcomes obtained will serve to refine and adjust PRECIOUS~     system concept and architecture.~   "
57162|NCT02818777|"~     There are two stages in the study. The major purpose of the Stage 1 is to study the safety~     and tolerability of the proposed dosage regimen of the study drug. The form of cannabidiol~     (CBD) used in this study is GWP42003, supplied by GW Pharmaceuticals. The dosage regime is~     based on their experience. This is an open label study in 10 subjects, during which the dose~     is gradually increased to the manufacturers recommended target dose, with tolerability being~     evaluated at each dose level. Based on the response of subjects in the Stage 1, a target dose~     is determined for the next stage. Standardized tools will be administered to study both~     tolerability and efficacy. Efficacy assessments are simply explorative, and are done to look~     for an effect that warrants specific or different evaluation in the next stage.~      The major purpose of Stage 2 is to assess the safety and tolerability of the GWP42003-P at~     the determined dose, and secondarily to study efficacy, particularly regarding tremor. Stage~     2 is a crossover, double-blind, randomized controlled trial (RCT) with 50 subjects.~   "
57163|NCT02818764|"~     The overall objective of this study is to test for perturbations in intraoperative~     electroencephalogram (EEG) , cerebral blood flow (CBF), cerebral metabolic rate of oxygen~     consumption (CMRO2), oxygen extraction fraction (OEF), and serum and cerebral spinal fluid~     biomarkers associated with delirium in high risk population having elective hip arthroplasty~     at Penn Presbyterian Medical Center (PPMC).~   "
57164|NCT02818751|"~     Neurofunctional Predictors of Escitalopram Treatment Response in Adolescents with Anxiety. To~     determine the effects of escitalopram on functional activation patterns during a Continuous~     Performance Task with Emotional and Neutral Distracters, the CPT-END. To examine baseline~     functional activity and functional connectivity profiles in the ventrolateral prefrontal~     cortex as markers of subsequent treatment response to escitalopram in adolescents with~     generalized anxiety disorder (GAD). To use proton magnetic resonance spectroscopy (1H MRS) to~     examine glutamatergic and γ-aminobutyric acid (GABA)-related abnormalities in the anterior~     cingulate in adolescents with GAD as compared to healthy adolescents.~   "
57165|NCT02818738|"~     Idiopathic Nephrotic Syndrome is sensitive to steroid in 90% of children. However, most~     patients relapse and become steroid-dependant, with a long lasting relapsing course. The aim~     of this study is to assess the efficiency of a 6-months levamisole course, given early after~     first remission, on maintaining a relapse-free course at 12 months.~   "
57166|NCT02818725|"~     OBJECTIVES OF THE TRIAL~      Primary objective~      Evaluation of efficacy in terms of progression-free survival at 9 months of the combination~     of intensified methotrexate, vinblastine, doxorubicin and cisplatin with or without~     panitumumab as first-line treatment of advanced urothelial carcinoma in patients without~     Harvey nor Kirsten rat sarcoma viral oncogene homolog mutations.~      Secondary objectives~        -  To assess toxicity~        -  To assess response rate~        -  To assess overall survival~        -  To assess time to progression~        -  To study the correlation between response rate, time to progression, overall survival~          and biological parameters~   "
57167|NCT02818712|"~     Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease with a high mortality.~     Health-related quality of life (HRQL) is impaired in patients with IPF. Little is known about~     the properties of recently developed HRQL questionnaires and about the longitudinal changes~     in HRQL, including factors with an impact on HRQL. Comorbidities have an impact on patients~     with IPF, but reports differ in incidence and prevalence. The impact of comorbidities on HRQL~     and disease progression has only been studied sparsely. Also, the association between~     biomarkers and disease progression need to be examined further.~   "
57168|NCT02818699|"~     The purpose of this clinical study is to determine the effect and safety of long-term intake~     of enzymatically modified isoquercitrin (EMIQ), a natural plant product on body fat loss in~     obese and overweight individuals.~   "
57169|NCT02818686|"~     This study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and~     pharmacodynamics (PD) of TD-1473 in subjects with moderately-to-severely active UC over 28~     days. This exploratory study will also serve as a signal seeking endeavor to demonstrate~     biologic effect associated with TD-1473 through biomarker analysis and clinical, endoscopic,~     and histologic assessments.~   "
57170|NCT02818673|"~     Refractory ascites is an indication for liver transplantation, and includes ascites that is~     resistant to, or intractable by diuretic therapy (International Ascites Club). This~     definition is partly subjective; it can be established only a posteriori, following diuretic~     therapy administration to all patients, including those in whom untoward effects are~     prominent; and requires prolonged follow-up. An early diagnosis of refractory ascites would~     avoid giving diuretic therapy to patients in whom it will fail and identify rapidly~     candidates to liver transplantation. Such diagnosis could be done with a pharmacokinetic (PK)~     study of radiolabeled albumin between the peritoneal cavity and serum.~   "
57171|NCT02818660|"~     There are two main stimulation tests used to decide if a patient has cortisol deficiency. It~     is the synacthen test, were we stimulate the patient with intramuscular or intravenous~     synacthen ( ACTH) to see how much cortisol the adrenals are capable of producing, and it is~     the Insulin hypoglycemia test were we give the patient insulin to provoke a hypoglycemia,~     and look at the adrenal response to that stimulus. The cut off values for a normal response~     is based on old immunological assays no longer in use. Assays with a lot of interference and~     cross reactivity leading to measurement of higher values for cortisol than what we measure on~     the highly specific LCMS/MS ( Liquid chromatography mass spectrometry methode) that we are~     using for cortisol today. So, there is a need for new cut off values for a normal response to~     such tests. The purpose of this study is to produce such new cutoff values by performing the~     test in 120 healthy controls. We also want to perform the test in patient groups normally~     going trough this tests according to the same protocol as the control persons, to evaluate~     the new cutoffs in different patient groups.~   "
57172|NCT02818647|"~     Patients 13-years-or older who undergo tonsillectomy operation (without another additional~     surgery) will be enrolled in the study. Randomly, one side is going to be operated with~     conventional cold-knife technique and hemostasis will be maintained with bipolar diathermy~     (25-30w). Contralateral tonsil is going to be operated with needle-tip monopolar~     electrocautery (10-12w) at Blend 1 mode and hemostasis will also be maintained with~     needle-tip monopolar cautery. Postoperative tonsillar fossa healing and pain is going to be~     evaluated for both sides separately with Visual Analogue Scale. All operations are going to~     be performed by a single surgeon and all evaluations are going to be carried out by another~     surgeon in a totally blinded fashion to avoid possible bias.~   "
57173|NCT02818634|"~     The purpose of this study was to investigate the effect of 'muscle sparing technique' while~     harvesting costal/rib cartilage on postoperative donor-site morbidity -namely postoperative~     pain. Although authors report 'muscle sparing technique' cause less pain its not investigated~     in an evidence-based-medicine perspective. Therefore the investigators are planning a~     controlled, prospective clinical trial to compare the conventional method and 'muscle sparing~     technique'.~      Effect of Costal Harvesting Technique on Postoperative Donor-site Morbidity: Does Muscle~     Sparing Technique Cause Less Postoperative Pain ? A Clinical Trial~   "
57174|NCT02818621|"~     Dexmedetomidine, a selective alpha2-adrenergic agonist is known to reduce propofol and opioid~     requirements due to its sedative and analgesic properties. However, until now, there has been~     studies based on indirect measures such as hemodynamics. Entropy shows to quantify the level~     of consciousness by EEG and Surgical pleth index(SPI) allows to predict the effect of pain~     stimuli and analgesic therapy by the index of the nociception-anti-nociception balance. The~     investigators analyzed quantitatively the requirements of propofol and remifentanil under~     continuous infusion of dexmedetomidine when using entropy and SPI.~   "
57175|NCT02818608|"~     The aim of this study is to verify the effectiveness of tDCS combined with FES on upper limb~     rehabilitation of post-stroke subjects with moderate and severe compromise.~   "
57176|NCT02818595|"~     Many cognitive functions in humans are based on asymmetrical brain networks. For example, in~     most adults, the language is essentially processed by the left hemisphere, while other~     auditory functions, such as voice recognition, tend to be processed by the right hemisphere.~     Many studies, especially those conducted by Ghislaine Dehaene's team, have demonstrated the~     presence of anatomical and functional asymmetries by the first months of life. What are the~     causes of these asymmetries? How do they develop? Are they necessary for functioning or~     effective learning?~      This study, conducted in collaboration with the Compiègne applied mathematics team (Abdelatif~     El Badia) and the INSERM team (Ghislaine Dehaene), is designed to determine the stage of~     development at which hemispheric dominance for voice recognition is first observed and to~     identify the brain structure involved in preterm neonates whose sound environment is usually~     very different from that of the foetus. The impact of this environment on the infant's brain~     development and early learning will be evaluated.~   "
57177|NCT02818582|"~     Background:~      Some people have Ebola virus in their body for months after they recover from Ebola virus~     disease. Some may have health problems from the virus while others are fine. These people may~     be able to pass the virus to others. There are currently no drugs for people who have~     survived Ebola virus disease but still have the virus in their body. A new drug, GS-5734,~     might help get rid of Ebola virus in semen.~      Objective:~      To test if GS-5734 helps get rid of Ebola virus in semen and is safe for humans.~      Eligibility:~      Men who participated in the Ebola survivor study (PREVAIL III) and have evidence of the Ebola~     virus in their semen~      Design:~      Participants will be screened with:~      Questions~      Physical exam~      Eye exam~      Blood tests~      2 semen samples if they have not had it tested recently~      Participants must live near the study site in Liberia for 6 months.~      Participants will be put into 1 of 2 study groups. They will have an infusion of either~     GS-5734 or a placebo every day for 5 days. A plastic tube is put into an arm vein. The~     infusion lasts 1 hour.~      Participants will be observed for 1 hour after. They will provide a semen sample on infusion~     day 4.~      After the infusions, participants will have 5 visits in the first month, then 1 per month for~     5 more months. These include giving a blood and semen sample.~      Blood tests are performed before and after each infusion and the last visit (5 month visit)~     will also include an eye exam.~      When the study is over, if the study drug works and is safe, participants who got the placebo~     can get the study drug.~   "
57178|NCT02818569|"~     The broad objective of this investigation is to assess the safety and efficacy of oral~     therapy with dexmedetomidine for the induction and maintenance of restful sleep.~   "
57179|NCT02818556|"~     This will be a single-center, randomized, evaluator-blinded, split-face clinical study~     design. Fifty patients will receive one treatment session consisting of Restylane® Silk~     (right side of the face) and Belotero Balance® (left side), or vice versa (1:1 dose~     conversion ratio) injections to the superficial, vertical perioral lines. Injections will be~     performed at the baseline visit. To ensure subject and investigator blinding, syringes will~     be prepared and labeled 1 and 2 immediately before subject attendance for injection by~     the sub-investigator. The same injection sites and techniques will be used on both sides of~     the face. Then, patients will follow-up on post-treatment day 7, 14, 30, 60, 90, 120, 150,~     180.~   "
57180|NCT02818543|"~     The purpose of this study to assess the pharmacokinetic profile in patients with active~     ulcerative colitis and compare it to the experience in healthy volunteers.~   "
57181|NCT02818530|"~     Intra ocular pressure (IOP) may theoretically increase due to steep Trendelenberg position~     and studies showed that IOP reaches peak levels after steep Trendelenberg position on an~     average of 13 mmHg higher than preanesthesia induction values. Major determinants of IOP are~     aqueous humor flow, choroidal blood volume, central venous pressure and extra ocular muscle~     tone.~      Hassen GW et al measured anterior chamber depth in 2 patients with glaucoma and compared the~     anterior chamber depth (ACD) with the intraocular pressure measured by tonometer. They~     concluded that bedside ultrasound could be useful in evaluating patient with suspected~     increased IOP, who are unable to open their eyes.~   "
57182|NCT02818517|"~     The survival rate of cancer patients has greatly increased over the past decades' mainly due~     to early detection and the use of new medications with higher doses and combined protocols.~     This achievement comes with the price of cardio toxicity, leading to cardiac dysfunction~     ranged from transient asymptomatic left ventricular dysfunction to cardiac death. In the long~     term, the risk of death from cardiovascular causes exceeds that of tumor recurrence for many~     types of cancer. As a result of the increasing number of long-term cancer survivors the~     magnitude of this problem is growing. Early identification of cardio toxicity can be~     identified by clinical follow-up and the use of electrocardiography, cardiac biomarkers~     (Troponin, brain natriuretic peptide) and echocardiogram. Past studies imply that the~     addition of angiotensin-converting-enzyme inhibitor (ACE inhibitor) and beta blockers to the~     patient's treatment may prevent the development of cardiac dysfunction. However, currently~     there are no specific or clear guidelines for the follow-up and management of cardio-toxicity~     in cancer patients.~      The aim of the study: To try to identify who are the patients at increased risk for~     developing cardio toxicity, by follow up of clinical evaluation, cardiac biomarkers and~     echocardiogram examination, in purpose of early diagnosis, management and prevention of~     cardiac events. For achieving this the investigators will build a registry which will include~     all the oncologic patients going an evaluation in the cardio-oncology clinic in the Tel Aviv~     Medical Center .~   "
57191|NCT02818400|"~     In hindsight, the first face graft raises the fundamental problem of composite tissue~     allotransplantation (hand, larynx, abdominal wall, etc.) with the addition of specific~     technical and philosophical problems.~      By proposing a prospective study concerning five new patients over the next three years, in~     the light of this first experience, the authors would like to confirm the surgical~     feasibility of this type of procedure, possibly extending it to other parts of the face~     (lateral third) and, like English and American teams, considering the possibility of total~     facial surface reconstruction.~      In parallel, and while complying with the usual immunosuppression procedures, the deliberate~     choice of creating a microchimerism by the infusion of bone marrow stem cells (the origin and~     quantity of which will need to be determined) will be reaffirmed, in order to improve~     mucocutaneous tissue tolerance, while confirming the safety of this type of approach.~      Five new cases will also provide observations for the many new fields of research developing~     around composite tissue transplants (neurophysiology, skin histopathology, psychiatry,~     haematology, immunology, etc.).~   "
57183|NCT02818504|"~     Cardio-metabolic risk factors include obesity, physical inactivity, smoke, alcohol abuse,~     high blood lipids or sugar and arterial hypertension. Systems for self-learning and~     self-monitoring may help people improve and maintain a healthy lifestyle through tailored~     suggestions about diet, weight control, physical activity, fatigue,stress.~      SEMEOTICONS exploits the human face as an indicator of individual's health status and~     translates signs obtained from the face using contactless sensors into measures and~     descriptors to be automatically evaluated by a an interactive smart mirror. This Wize~     Mirror extracts descriptors from videos, images and gas concentration signals and integrates~     them in a virtual model used to compute and trace the evolution of an individual's wellness~     index. A health diary enables each individual to evaluate and personally relate his/her~     lifestyle to his/her well-being. Coaching messages are provided, in relation to the evolution~     of the wellness index and of each descriptor, to provide useful suggestions on correct~     lifestyle self-monitoring.~      The purpose of this study is assess the accuracy of the information derived from the Wize~     Mirror in expressing the health status of the individual.~      The reproducibility and repeatability study will evaluate whether measurements are stable~     over short time spans and whether they are influenced by meals light and temperature~     conditions.~      To verify whether the Wize Mirror is able to detect variations in physical and emotional~     health status with appropriate lifestyle changes, the validation study will cross-check~     measurements from the Wize Mirror against reference clinical tests at enrolment and after 3~     months of personalized suggestions for healthy behavior.~      Reference tests include~        -  Physician visit~        -  Measurement of blood oxygen content and skin end products of sugar metabolism,body~          composition, energy expenditure, vascular function~        -  Laboratory profile and exhaled gas composition~        -  Questionnaires on quality of life and lifestyle (food, sleep, physical activity,~          smoking, alcohol, stress).~      Wize Mirror measures include~        -  3D reconstruction of face images for roundness, color, stress and fatigue~        -  Heart and respiratory rate~        -  Detection of skin sugar metabolism end-products and of eye lipid deposits~        -  Small vessel vasodilating ability with local heating The results will allow to assess~          whether the Wize Mirror is easy to use and helpful for self-monitoring of~          cardio-metabolic risk.~   "
57184|NCT02818491|"~     Shoulder surgery is associated with moderate to severe postoperative pain. Interscalene~     brachial plexus block is considered by many as the gold standard for treating postoperative~     pain and consists of injecting local anaesthetics close to the nerves of the brachial plexus~     in the neck. Duration of analgesia is between eight to twelve hours depending on the type of~     administered drugs. Dexamethasone 4 mg is a steroid routinely injected intravenously in~     anaesthesia for the prophylaxis of postoperative nausea and vomiting. Recently, different~     trials have demonstrated that combining 4 to 8 mg of dexamethasone with local anaesthetics~     for a perineural injection may prolong the duration of analgesia up to 24 hours. In a~     meta-analysis including 29 trials and 1695 patients, investigators have recently demonstrated~     through a meta-regression that a dose of 4 mg is sufficient and represents a ceiling dose,~     without neurological complications. The objective of this multicenter randomised controlled~     double-blinded trial is to determine the optimal dose of perineural dexamethasone. For that~     purpose, investigators will include a total of 150 patients divided in 5 groups: local~     anaesthetics with placebo, or with dexamethasone 1, 2, 3 and 4 mg.~   "
57185|NCT02818478|"~     To investigate if electronic reporting of patient reported outcome measures from home is~     comparable to the traditional touch-screen solution to hospital among patients with~     rheumatoid arthritis and axial spondyloarthritis~   "
57186|NCT02818465|"~     Chronic kidney disease (CKD) is associated with an extensive vasculopathy and high~     cardiovascular mortality as well as an accumulation of uremic toxins. Among the latest,~     advanced glycation end-products (AGEs) interact with RAGE. Investigators aimed to analyze the~     role of RAGE in the calcification process of hemodialyzed patients, in a correlative and~     prospective study. Vascular calcifications will be assessed by Xray and tomodentimetry while~     accumulation of AGEs will be measured in the serum and in the skin (non invasive).~     Additionally factors influencing RAGE activation such as genetic polymorphism and level of~     soluble forms of RAGE will be measured and analyzed.~   "
57187|NCT02818452|"~     The objective of this study is to determine the effect on glycemic responses of adding~     various doses of OatWell28XF to Quaker Instant Oatmeal in order to: 1) describe the~     dose-response curve and 2) If possible, identify the minimum level of OatWell28XF which, when~     added to a serving of Quaker Instant Oatmeal, would result in a glycemic response at least~     20% less than that elicited by a β-glucan-free cereal.~   "
57188|NCT02818439|"~     ARPEGE project fits within the general framework of maintaining functional autonomy in the~     frail elderly. The early identification of elderly people at risk of frailty is essential to~     be able to make corrective actions to maintain a quality of life desired by the person.~     ARPEGE offers tracking and monitoring based on a corpus mobile evaluation of frailty, that~     could be used in various environments (home, prevention center, office of the general~     practitioner, geriatric consultation), and manipulated intuitively by professionals not~     specialists.~      This four-year project spearheaded by the University of technology of Troyes in partnership~     with the University of Reims Champagne-Ardenne also brings a set of partners and experts in~     the region and outside, so that the proposed solution has the qualities necessary for its~     deployment in terms of value diagnostic, use, acceptability and perfectly controlled ethics.~      The Region has made longevity aging theme one of its priorities. This image of driver of~     innovation in this area can only be enhanced by a program like ARPEGE. Beyond the scientific~     and technological results expected, one can imagine the potential socio-economic benefits if~     this tracking solution is deployed on a large scale.~   "
57189|NCT02818426|"~     UCPVAx is a therapeutic vaccine based on the telomerase-derived UCP designed to induce strong~     TH1 CD4 T cell responses in cancer patients.~      Three doses of UCPVax (0,25 mg, 0,5 mg and 1 mg) will be tested in this phase I/II study by~     using Continuous Reassessment Method (CRML) dose escalation design model.~      The phase I is a dose escalation study designed to evaluate safety of use of UCPVax and to~     estimate its Maximum Tolerated Dose (MTD).~      The phase II is a dose deescalation designed to evaluate the immunogenicity of UCPVax~     according to the dose level.~   "
57190|NCT02818413|"~     This research is being done to investigate fecal microbiome and metabolome as well as serum~     analytes and single nucleotide polymorphisms in Olympic athletes in comparison with other~     elite athletes.~   "
57214|NCT02818101|"~     The purpose of this study is to confirm the utility for hypnosis in the coronary angiographic~     examination. The technique would be an alternative to prevent the consumption of anesthesic~     drugs.~   "
57215|NCT02818088|"~     This unique study will allow us to observe the neural correlates associated with working~     memory in an obsessive compulsive disorder (OCD) paradigm. We believe that developing working~     memory in participants suffering with OCD will reduce the severity of their symptomology.~     This will allow a greater understanding into the functioning of these participants which in~     turn presents with treatment possibilities.~   "
58198|NCT02805114|"~     This is an observational study which aims to evaluate the possibility of using data from a~     capnography device to assess obstructive airway severity in both Chronic Obstructive~     Pulmonary Disease (COPD) and Asthma patients.~   "
57192|NCT02818387|"~     Propofol is a well-known induction agent which can provide sound and quick hypnosis with~     anti-emetic effects. However, dose dependent hypotension or bradycardia have reported while~     using this agent. Propofol in combination with remifentanil or midazolam can result in~     synergistic or additive effect in elderly patients. There are not many studies which provide~     minimum dose of propofol to induce hypnosis in combination with these agents and advantage of~     the combination.~      The elderly patients (over 65 years old) who are scheduled to undergo general anesthesia are~     enrolled in this study. 120 patients will be randomly allocated to 3 groups(P, PR, PMR).~     Sample size have been decided due to the previous studies which have mentioned 40~     participants as a adequate sample size for this biased coin design - up and down study.~      After receiving informed consent, patients will be participated in this study. No~     premedication will be given to the patients before induction. The patients in group P will~     receive general anesthesia only with propofol and group PR and PMR will receive 0.125~     mcg/kg/min remifentanil infusion for 5 min prior to propofol administration. The patients in~     group PMR will receive 0.015 mg/kg bolus dose of midazolam 1 min after the start of the~     remifentanil infusion. Initial propofol dose will be 0.5 mg/kg in each group and the dose~     will be changed by the result of prior study participant.~      'Success' of this study will be defined as loss of both verbal response and eyelash reflex in~     3 min after propofol administration. When 'success', the next patient will receive the same~     dose(in 18/19 probability) or 0.125 mg/kg lower dose(in 1/19 probability) of propofol. When~     'failure', the next patient will receive 0.125 mg/kg higher dose of propofol at induction~     period.~   "
57193|NCT02818374|"~     The purpose of this study is to evaluate the efficiency and the safe use of a new medical~     device to improve the oral accessibility of disabled people during the oral-dental~     examination.~   "
57194|NCT02818361|"~     Tripterygium wilfordii Hook F (TwHF), a traditional Chinese herb, is widely used in China for~     treating Rheumatoid Arthritis (RA), but limited only for elderly RA patients because of its~     reproductive system toxicity. The investigators are inspired by Chinese external therapy, an~     immemorial therapy for thousands of years, and take its advantage to make TwHF topically in~     order to get an effective and safe treatment for active RA patients.~   "
57195|NCT02818348|"~     This study aims to provide information about the safety and pharmacokinetic drug-drug~     interactions between darunavir/cobicistat (800/150mg QD) and etravirine (400mg QD) in~     HIV-infected patients, as well as evaluate the efficacy of concomitant administration of~     darunavir/cobicistat and etravirine.~   "
57196|NCT02818335|"~     The purpose of this study is to measure how much LY3023414 (a test formulation and a~     reference formulation) gets into the blood stream and how long it takes the body to get rid~     of it.~      The study will also evaluate the effects of a high fat meal on LY3023414 compared to taking~     LY3023414 on an empty stomach. In addition, the tolerability of the study drug formulations~     will be evaluated. Information about any side effects that may occur will be collected.~      This study includes 3 periods. Participants will be admitted to the clinical research unit~     (CRU) one day before dosing in each period. Total study duration is about 21 days, including~     follow-up. Screening may occur up to 30 days before the first dose of study drug.~      This study is for research purposes only and is not intended to treat any medical conditions.~   "
57197|NCT02818322|"~     The role of telemedical monitoring in diabetic foot care is still uncertain. The aim is to~     compare telemedical + standard and standard alone outpatient monitoring in the care of~     patients with diabetic foot ulcers in a randomized controlled trial. The primary outcome of~     the overall study is the time of ulcer healing. The number of amputation, hospital admissions~     and surgical procedure will be also reported. Investigators hope to include 150 patients in~     this study.~   "
57198|NCT02818309|"~     Lesogaberan may be used in Chinese GERD patients with partial response to PPI.~   "
57199|NCT02818296|"~     This investigation examines the efficacy of a brief, one-session computerized interpretation~     bias modification paradigm (CBM-I) in the reduction of intolerance of uncertainty.~     Intolerance of uncertainty is a risk factor for the development and maintenance of various~     forms of psychopathology.~   "
57200|NCT02818283|"~     Combination antiretroviral therapy (ART, HIV medications) dramatically increases the expected~     lifespan of HIV (Human Immunodeficiency Virus)infected patients; yet, the risks for~     cardiovascular disease (CVD), such as heart attacks and stroke, are increased in this~     population. This increased risk may be linked to persistent inflammation and activation of~     the immune system. Although the relationship between cardiovascular disease and HIV-infected~     individuals who are taking HIV medications is not well understood, the team of researchers~     involved in this study observed that a diet rich in soy, at levels recommended by the FDA~     (Federal Drug Administration), improved cholesterol levels and inflammation in individuals~     not infected with HIV. From this study, the researchers hope to gain understanding on how~     dietary soy will impact HIV-infected individuals who are taking HIV medications. Two pretzels~     with and without soy developed at OSU (Ohio State University) in the Department of Food~     Science and Technology and used in previous clinical trials will be used to investigate how~     the pretzel snacks will affect your cardiovascular disease risk, immunity, and how your body~     breaks down naturally occurring chemicals from soy.~   "
57201|NCT02818270|"~     Aerosol delivery through a ventilator is influenced by numerous factors from~     ventilator-related, circuit-related to device-related factors. Aerosolized drug delivery~     through a ventilator system was studied on bench model with albuterol, yet the results were~     often overestimated. The objective of this study was to evaluate inhaled bronchodilator and~     mucolytic agents delivered through a ventilator system.~   "
57202|NCT02818257|"~     The aim is to investigate the impact that water absorption properties in adhesives has on~     adhesion.~   "
57203|NCT02818244|"~     In 2015, over 85 million fitness wearables were sold worldwide and the market is projected to~     expand to 110 million units sold in 2017. Of all wearable technology, fitness devices that~     track heart rate are predicted to be the most popular. At the elite level, commercial heart~     rate monitors are being used by athletes like LeBron James, Blake Griffin, and Matthew~     Dellavedova to monitor and alter their behaviors for peak athletic performance. Millions of~     ordinary consumers purchase fitness trackers that include heart rate monitors in order to~     help them to maintain their health and wellness. As popularity of these fitness devices~     grows, assessment of the accuracy of heart rate measurements becomes increasingly important.~   "
57204|NCT02818231|"~     Nasal adenocarcinomas are closely related to wood dust exposure. The precise mechanisms of~     carcinogenesis leading to the transformation of the respiratory mucosa into a colonic-like~     mucosa remain unknown: chronic exposure to wood dust may cause chronic inflammation that may~     lead to pre-degenerative lesions, hypothesis yet unconfirmed. The tumor development requires~     the activation of a particular gene: CDX2. The working hypothesis is that chronic wood dust~     exposure is responsible for changes in genes of inflammation, which can in turn lead to~     changes in the expression of CDX2 and its cofactors, thus making possible the genesis of~     adenocarcinoma. This work is a pilot study aiming to better understand the mechanisms of~     carcinogenesis, and to study the feasibility of a larger prospective screening for~     woodworkers adenocarcinomas. Cells will be obtained from the at risk area (olfactory cleft)~     by a noninvasive method (brushing) in healthy volunteers (unexposed to wood dust) and in~     exposed volunteers to compare their genomes and study the genomic changes related to wood~     dust exposure.~   "
57205|NCT02818218|"~     Consecutive patients undergoing liver transplant surgery will be included in the study.~     Before surgical incision, during the preanhepatic phase, during the anhepatic phase, during~     the postanhepatic phase and following closure of the deep fascial layer of the anterior~     abdominal wall simultaneous measurement of SVC diameter, SBC collapsibility index and CVP~     will be recorded.~   "
57206|NCT02818205|"~     The purpose of this study was to explore the feasibility of detecting physiological patterns~     of arousal to sensory inputs in children with and without Autism Spectrum Disorder (ASD).~     Accordingly, two questions directed this methodological research investigation: (1) Is there~     a relationship between rest (tonic) and response (phasic) patterns of arousal among typically~     developing children and children with ASD?, and (2) Is there a difference in EDA response to~     sensation between typically developing children and children with ASD?~   "
57207|NCT02818192|"~     The overall aim of the project is to elucidate the primary bio-psycho-social (BPS) risk~     factors for albuminuria in youth with type 2 diabetes (T2D) and the mechanisms by which they~     cause renal injury. The Study Aims include:~        1. Characterize the primary BPS risk factors associated with prevalent and progressive~          albuminuria in youth with T2D.~        2. Determine individual, family and community level factors that influence biological and~          psychological risk factors and behaviors (adherence) that could be modified to protect~          against prevalent and progressive albuminuria.~        3. Determine if systemic and renal inflammation is the common pathway through which BPS~          risk factors lead to albuminuria in youth with T2D.~      Study Hypotheses include:~        1. Biological factors (poor glycemic control and systolic ambulatory hypertension), and~          psychological and social adversity (stress, mental distress and poverty) are significant~          predictors of prevalent and progressive albuminuria in youth with T2D.~        2. Community and family support will be negatively associated with stress, and a lower risk~          of both prevalent and progressive albuminuria.~        3. Systemic and renal inflammation is the common pathway through which BPS risk factors~          lead to albuminuria in youth with T2D.~   "
57208|NCT02818179|"~     This research aims to investigate the correlation between tumor temperature difference and~     biological factors, such as size, metabolism, treatment response, and tumor aggressiveness.~      In addition, normal tissue response to radiation therapy in treated organ will be evaluated.~   "
57209|NCT02818166|"~     The purpose of this study is to prospectively evaluate major and minor neurologic events in~     patients undergoing right mini-thoracotomy mitral valve surgery and to compare different~     aortic clamping techniques; specifically, the endoaortic balloon with retrograde perfusion~     (Endoreturn) and the transthoracic clamp with retrograde perfusion. Major neurologic events~     will be evaluate through standard neurologic evaluation; minor neurologic events will be~     evaluate through magnetic resonance (MR) assessment.~      The first aim of the study is to determine the number and impact of microembolic events~     during right mini-thoracotomy mitral valve surgery on clinical neurological status and on MR~     evaluation. The investigators also aim to determine if different techniques of aortic~     clamping may impact on early outcome.~      Study hypothesis: despite recent concerns arising about endoaortic balloon with retrograde~     perfusion, the investigators expect to show equivalence in term of safety and effectiveness~     of this technique compared with the transthoracic clamp in a selected population.~   "
57210|NCT02818153|"~     Allergic rhinitis is a common condition that affects adults as well as children and~     adolescents, often with impaired quality of life. Patients often report a poor level of~     satisfaction with the effectiveness of their treatment and are always looking for more drug~     combinations to improve their symptom. Several tools exist for assessing control of allergic~     rhinitis, but none has been validated in adolescents or in children. A study conducted in~     2008, resulted in the validation of a self-administered control test of allergic rhinitsis~     (ARCT) in patients from 12 years of age. However, this study included only 67 adolescents~     aged 12 to 17 years old and lacked power.~      In this new study,the investigators propose, following exactly the same procedure as the~     pilot study of 2008, to confirme the validation of unmodified Adult questionnaire in~     adolescents 12 to 17 years inclusive.~   "
57211|NCT02818140|"~     Patients undergoing percutaneous nephrolithotomy (PNL) suffer from acute postoperative pain,~     despite a multimodal analgesic regime.~      We hypothesize that active (ropivacaine) transmuscular quadratus lumborum (TQL) block will~     significantly reduce postoperative opioid consumption and pain following PNL operation~     compared with placebo (saline) TQL block.~      The aim of this study is to investigate the effect of ultrasound-guided (USG) TQL block~     concurrent with a multimodal analgesic regime compared to the multimodal analgesic regime~     alone (and placebo TQL block) in a randomized and placebo controlled design.~   "
57212|NCT02818127|"~     The aim of this study is to evaluate and describe the total coronary circulation time (TCCT)~     by using TIMI frame count method in patients performed coronary angiography. TCCT is~     described as an angiographic index which is the sum of the frame count of coronary artery and~     venous system. This study also evaluates the relationship between the diseases in arterial~     system such as coronary artery ectasia, coronary slow flow, coronary artery disease and~     coronary venous pathologies.~   "
57213|NCT02818114|"~     The investigators plan to develop and test an intervention using peer specialists (Veterans~     who have managed PTSD and completed PE) to provide support services for Veterans using~     prolonged exposure therapy.~   "
57216|NCT02818075|"~     This pilot study will evaluate the feasibility and acceptability of a mobile phone based peer~     support intervention among adolescent mothers. Half of the participants will receive usual~     care plus the peer support intervention and the other half of the participants will receive~     usual care only.~   "
57217|NCT02818062|"~     The host-immune reaction to infection is essential for the comprehension of the disease and~     the development of new therapies.~      The aim of the study is to describe intraocular cytokines network in aqueous humor using~     multiplex immunoassay, during severe intraocular infection.~   "
57218|NCT02818049|"~     The acute respiratory distress syndrome (ARDS) is a clinical syndrome characterized by an~     inflammatory pulmonary edema, severe hypoxia and endothelial and epithelial diffuse~     aggression. A European study estimated that this disease represents 7% of admissions to~     intensive care. Despite progress on the modalities of mechanical ventilation, mortality is~     always between 25 and 55%. The definition of this syndrome was recently amended by~     individualizing three sub groups based on the importance of hypoxemia (mild, moderate and~     severe). Achieving a bronchoalveolar lavage (BAL) by bronchoscopy remains a gold standard in~     the initial research of pulmonary infectious cause or secondarily face the suspicion of~     ventilator-associated pneumonia. Cardio pulmonary consequences of this act are not well known~     in patients with ARDS. The first studies on the consequences of a bronchoscopy on oxygenation~     of a patient breathing spontaneously have 40 years. More recent work showed a simple~     bronchoscopy could in the mechanically ventilated patient cause an average decrease of 26%~     from the base of PaO2, 10% of the mean arterial pressure (MAP) and a significant increase in~     cardiac output. The existence of ARDS was an independent risk factor associated with~     hypoxemia. A study by published in Crit Care Med in 1990 can serve as a reference in~     ventilated patients benefiting from BAL by bronchoscopy: in a subgroup of 26 patients, 23% of~     patients required an increase in the fraction of inspired oxygen (FiO2) post procedure. A~     study compared changes in PaO2/FiO2 after BAL with and without endoscopy among patients~     without (n = 23) or with pneumonia (n = 11): the decrease in PaO2/FiO2 was significant only~     in the pneumonia group. In a study of 30 patients ventilated but not hypoxic , PaO2 was~     still reduced by 20% 2 hours after the completion of a BAL in 40% of patients. A~     retrospective series of 99 ventilated patients but not hypoxic, shows that the BAL was well~     tolerated in accordance with a pre oxygenation procedure 15 min and by gradually decreasing~     the FiO 2 after the end of the procedure. BAL also appears well tolerated in a study of 12~     patients ventilated under sedation and muscle relaxation, in shock and in need of positive~     expiratory pressure (PEEP) of at least 10 cm H2O but the authors show a decrease in PaO2 that~     extends well beyond the end of the intervention. Their conclusion is going to offer less~     invasive diagnostic techniques for patients with PaO2 less than 60 mm. No study has targeted~     the respiratory and hemodynamic consequences of this technique depending on the intensity of~     ARDS (mild, moderate or severe).~   "
57219|NCT02818036|"~     The purpose of the study is to explore the effect of blocking opioids on affiliation-related~     neural activity.~   "
57220|NCT02818023|"~     The study plans to treat patients with pembrolizumab and thus blocking the PD-1/PD-L1 axis~     would render tumor-infiltrating lymphocytes (TILs) in the tumor parenchyma more functional as~     a consequence of BRAF inhibition, such that T cell activation by BRAFi would not be dampened~     by the PD-1/PD-L1 interaction. This combination would reverse dysfunction among T cells in~     the tumor parenchyma, maximizing T cell mediated immune anti-tumor efficacy. Progression free~     survival (PFS) with pembrolizumab in KEYNOTE-001 was 57% at 6 months, and 46.4% in the more~     recently reported phase III trial. PFS with vemurafenib treatment in BRIM-3 was ~50% at 6~     months. Combined treatment with pembrolizumab, cobimetinib and vemurafenib for BRAF mutant~     melanoma is hypothesized to be safe and to improve the PFS compared to these recent~     historical controls. Because this combination has not yet been tested, and because the~     primary objective is to assess safety, the investigators are staging accrual in the first~     phase of the trial. The study aims to accrue up to 50 patients to the mTPI design of this~     study with the expectation that there will be at least 30 patients treated at RP2D. In case~     there are less than 30 patients on the RP2D, additional patients will be accrued. Patients~     will continue to receive treatment with pembrolizumab, vemurafenib and cobimetinib until~     disease progression or dose limiting toxicity. Patients with treatment response and no dose~     limiting toxicity may receive treatment with pembrolizumab for up to 24 months.~   "
57221|NCT02818010|"~     PHYSALYS is an observational multicenter study. It's an analytical study comparing 2 groups:~     patients exposed to physical activity and unexposed. The main objective of the study is to~     compare the evolution of glomerular filtration rate at inclusion and 12 months later between~     patients practicing physical activity and patients not practicing. If necessary, the renal~     disease-related complications, which are not influenced by physical activity: (type of kidney~     disease, age and tobacco), would be taken into account. TIRCEL patients with chronic kidney~     disease (CKD) at stages 3, 4 or 5 can be included in the study. Their serum creatinine data,~     12 months prior to inclusion, is collected retrospectively. Patients are followed in the~     trial during 12 months. To evaluate physical activity, patients respond to Global Physical~     Activity Questionnaire 2 (GPAQ2) at inclusion and 12 months later. During this 12 months~     period, the same biological data are collected prospectively.~   "
57222|NCT02817997|"~     The purpose of this study is to collect clinical, laboratory, and patient survey data from~     patients with Castleman disease to improve understanding, diagnosis, and treatment of the~     disease.~   "
57223|NCT02817984|"~     The purpose of this study is to assess the safety and tolerability of acellular adipose~     tissue (AAT), intended for the repair of soft tissue defects in humans, in healthy~     volunteers. The investigators hypothesize that AAT will be safe and well tolerated upon~     injection into human soft tissue.~   "
57224|NCT02817971|"~     A cluster randomised pragmatic trial will be conducted within an emerging clinical~     information network composed of 12 Kenyan county hospitals. Hospitals will be randomised to~     an enhanced feedback intervention delivered over a nine-month period and compared to standard~     feedback. The trial to be implemented during a phase of implementing change in guideline~     recommendations for pneumonia will assess the impact of enhanced feedback on hospital uptake~     of the revised pneumonia treatment recommendations.~   "
57236|NCT02817815|"~     Arterial thromboembolism constitutes a major risk of atrial fibrillation (AF) requiring~     antithrombotic therapy. Platelets and microparticles (MPs) are important for hemostasis and~     thrombosis, their role during AF is not well known. The principal objective of this study is~     to compare morphologic, functional and proteomics characteristics of blood platelet between~     AF patients and healthy volunteers.~   "
57237|NCT02817802|"~     The registry will investigate the clinical performance and long-term safety of Magmaris in a~     real world setting~   "
57253|NCT02817594|"~     The interferon-free combination regimen of Paritaprevir/r - Ombitasvir with or without~     Dasabuvir (ABBVIE REGIMEN) ± Ribavirin (RBV) for the treatment of chronic hepatitis C (CHC)~     has been shown to be safe and effective in randomized controlled clinical trials with strict~     inclusion and exclusion criteria under well controlled conditions.~      This observational study is the first effectiveness research examining the ABBVIE REGIMEN ±~     RBV, used according to local label, under real world conditions in the Netherlands in a~     clinical practice patient population.~   "
57225|NCT02817958|"~     Squamous cell carcinoma of the penis is a rare tumor in Europe, whose prognosis and survival~     are influenced by metastatic lymph node involvement. Its frequency in France is estimated at~     less than 1% of human cancers. This spread follows a sequential process via the superficial~     and deep inguinal lymph nodes and then to the pelvic lymph nodes before metastatic~     dissemination.~      The management of inguinal areas is the cornerstone of penile cancer. It is curative in about~     80% of patients with 1 or 2 inguinal metastases. 5-years overall survival was on average 85%~     for pN0 patients and 40% for pN + patients. For pN + patients, 5-years overall survival was~     70 to 80% for pN1 (only 1 lymph node invasion), and 30 to 40% for pN2 and 0 to 10% for pN3.~      The risk of local recurrence is 5-10% for pN0 and 20-30% for pN + after local treatment by~     lymphadenectomy alone without chemotherapy. The average time to recurrence was 10 months.~     Disease-free survival at 5 years is 75-85% for pN0 and 30-45% for pN +. Its indication~     depends on clinical examination (presence or absence of lymph nodes palpated) and the risk of~     nodal disease (≥ pT1bG2).~      Currently, a fine needle biopsy is the best clinical diagnosis method because it is a simple,~     low risk and possible in consultation. When the result is positive, it allows an early~     dissection. Single or double fine needle biopsy will be used in cN + patients. For patients~     at risk of lymp nodes involvement (cN0 and ≥ pT1B or G2), the sentinel node diagnosis may be~     followed by modified or bilateral lymphadenectomy.~      Although lymphadenectomy alone has a curator action, it sometimes remains insufficient in~     patients with metastatic lymph node involvement. Therefore it seems important to develop a~     multimodal approach in the management of these patients in order to increase the response~     rate to treatment and survival.~      From a Phase II trial conducted on 30 patients, the combination TIP (paclitaxel, ifosfamide~     and cisplatin) appears to have an efficacy / toxicity acceptable.~      The TIP protocol has therefore been chosen for this trial as adjuvant or neo-adjuvant~     treatment in patients with high risk of lymph nodes involvement (cN0 and ≥ pT1B or G2), and~     with inguinal mobile palpated lymph nodes (cN +) respectively, after lymph nodes involvement~     proven (pN +).~   "
57226|NCT02817945|"~     This is an open-label positron emission tomography/computed tomography (PET/CT) study to~     investigate the diagnostic performance and evaluate the efficacy of 68Ga-NOTA-3PTATE-RGD in~     lung cancer patients. A single dose of 111-185 Mega-Becquerel (MBq) 68Ga-NOTA-3PTATE-RGD will~     be injected intravenously. Visual and semiquantitative method will be used to assess the~     PET/CT images.~   "
57227|NCT02817932|"~     The purpose of this study is:~      To assess the pharmacokinetic profile and safety of ranolazine PR in healthy Korean and~     Caucasian volunteers after oral administration of Ranolazine at the doses of 375, 500, 750mg~     after single and repeated oral administrations.~   "
57228|NCT02817919|"~     This cohort event monitoring will document real-life safety experiences following the intake~     of Injectable AS. Specifically, the study will record common adverse events that are~     associated with the use of Inj. AS and associating factors such as age and gender that make~     some of these events more likely. The sample size of 3000 patients will enable the~     documentation of causally-related events that occur at frequencies of 1 in 1000 or more.~     Since quinine, the previous gold standard for treating severe malaria may still be used by~     facilities in addition to artesunate and artemether, the study will concurrently monitor the~     safety of these products though focus of the study is the capture of adverse events following~     exposure to Inj. AS. The concurrent monitoring of both quinine and artemether will also~     enable treatment practices in the study areas to be documented.~   "
57229|NCT02817906|"~     This is a randomized, double-blind, placebo-controlled study comparing the efficacy and~     safety of ITI-007 versus placebo administered orally once daily in the treatment of agitation~     in patients with dementia, including Alzheimer's disease.~   "
57230|NCT02817893|"~     The waveform plethysmographic signal can be used to establish an index for predicting fluid~     responsiveness (∆POP: respiratory variation of the plethysmographic waveform of pulse~     oximetry). This index was validated in some studies and because of its non-invasiveness it~     seems very interesting in anesthesia.~      However, in a previous study the investigators evaluated the correlation between the results~     provided by this index (∆POP) and those of the reference index (∆PP: pulse pressure~     variation), and the obtained results were significantly lower than what had been previously~     described. In this study, the index was calculated from a recording of a filtered signal.~     This unavoidable application of a filter on anesthesia monitors could contribute to the~     discrepancy between the ∆POP and the ∆PP.~      The realization of a new study, comparing ∆PP and ∆POP obtained from an unfiltered~     plethysmographic signal, should answer the ∆POP ability to be used in place of ∆PP.~   "
57231|NCT02817880|"~     The purpose of this study is to compare the analgesic effectiveness of two motor cortex~     neurostimulations (tDCS and rTMS) and the trans-spinal neurostimulation (tsDCS ) in the~     algoneurodystrophy.~   "
57232|NCT02817867|"~     Cerebrovascular accident (CVA) is a cerebrovascular disease with high incidence and morbidity~     in the Brazilian population, and is considered a major cause of disability in adults. Brain~     damage caused by stroke generates a maladaptive pattern of neural activity and modulation~     between the cerebral hemispheres, unbalancing in the inter-hemispheric inhibition. This~     condition affects patient's functional recovery.~      The aim of this study is to verify the effectiveness of repetitive transcranial magnetic~     stimulation Association (rTMS) in the cortex motor contralesional, Transcranial Direct~     Current Stimulation (tDCS) in the motor cortex ipsilesional and the association between these~     two types of brain stimulations on the upper limb recovery after stroke.~   "
57233|NCT02817854|"~     Diverticular disease is a common disease in developed countries, affecting 2.5 million~     individuals in the United States (US). Prevalence of diverticula increases with age and goes~     up to 50 to 66% in patients older than age 80 years. Approximately 10 to 25% of patients with~     diverticulosis will develop diverticulitis. Acute diverticulitis (AD) accounts for 312,000~     admissions and 1.5 million days of inpatient care in the US, where its annual treatment costs~     exceed 2.6 billion dollars. With the ageing of global population these numbers are expected~     to rise.~      Procalcitonin (PCT) is a biomarker widely used to monitor bacterial infections and guide~     antibiotic therapy in Intensive Care Units and has been shown to be useful in different~     surgical fields such as acute appendicitis. Recently, has been demonstrated that PCT and CPR~     have good predictive value of anastomotic leak (AL) after colorectal surgery.~      A multicentric study has been designed to test if PCT, CRP and WBC values might be able to~     predict the outcomes of patients admitted in emergency setting for acute diverticulitis. In~     particular if they might distinguish between patients needing only conservative (nothing per~     os, iv fluids and antibiotics) or interventional therapy such as radiological drain or even~     surgery, in the aim to optimize and individualize each patients therapy and speed patients~     discharge.~   "
57234|NCT02817841|"~     The objectives of this study are to evaluate the contraceptive efficacy, vaginal bleeding~     pattern (cycle control), and the general safety and acceptability of the 15 mg estetrol~     (E4)/3 mg drospirenone (DRSP) combination in healthy women aged 16 to 50 years.~   "
57235|NCT02817828|"~     The objectives of this study are to evaluate the contraceptive efficacy, vaginal bleeding~     pattern (cycle control), and the general safety and acceptability of the 15 mg estetrol~     (E4)/3 mg drospirenone (DRSP) combination in healthy women aged 18 to 50 years.~   "
57238|NCT02817789|"~     Transcatheter Aortic Valve Implantation (TAVI) is now the method of choice to treat aortic~     stenosis in old and frail patients. Antiplatelet therapy must be associated for the procedure~     and during few weeks after implantation in the aim to minimize cerebral embolization. But for~     now, the best antiplatelet regimen has to be determined. In this context, investigators want~     to evaluate the safety of use of ticagrelor alone versus standardized therapy which involves~     lysine acetylsalicylate and clopidogrel. In this study, we will randomly compare 154 patients~     in each group in terms of early safety (30 days) after the procedure.~   "
57239|NCT02817776|"~     This is a prospective, multicenter, non-randomized clinical evaluation utilizing the~     THERMOCOOL SMARTTOUCH® SF catheter compared to a predetermined performance goal.~   "
57240|NCT02817763|"~     The aim of the present study is to evaluate the clinical, aesthetic and patient-centered~     parameters of connective tissue graft associated or not with partial resin composite (RC) for~     the treatment of gingival recession with NCCL, performed before the surgical procedure.~   "
57241|NCT02817750|"~     The purpose of this study is to evaluate the pharmacokinetics of the new formulation of~     zolpidem hemitartarate orodispersible tablet 3.5 mg in male and female healthy volunteers.~   "
57242|NCT02817737|"~     Purpose: This study outlines the benefits of the proximal tibia angle (PTA) in evaluation of~     the pre-operative individual condylar twist angle (CTA) in total knee arthroplasty.~      Methods: Condylar twist angle and proximal tibia angle were obtained from 33 female healthy~     participants using computed tomography (CT). The CTA, angle between clinical transepicondylar~     axis and posterior condylar line were measured. The PTA is the angle formed between the~     mechanical axis of the tibia and tibia plateau line. The correlation between the CTA and the~     PTA was analyzed statistically with the linear regression.~   "
57243|NCT02817724|"~     The purpose of this study is to determine if it is better an integral strategy, with a~     m-health system, when used in addition to a supervised treatment, versus the use of the~     m-health system alone, to improve the immediate and long-term Quality of Life of breast~     cancer survivors.~   "
57244|NCT02817711|"~     The prospective Cohort includes all patients with bone or joint infection (BJI), with or~     without implant. The aim of this Cohort is to improve the knowledges about the treatment~     failure and the occurrence of serious adverse events. Various data of patients included are~     collected and will be analysed.~      Patients with a bone or joint infection are treated at the department of infectious diseases,~     at Infectious disease department of Hospices Civils de Lyon. They have regularly a~     consultation with a physician: 2-3 weeks after surgery, 6 weeks after surgery, 3 months after~     surgery, 6 months after surgery, 12 months after surgery and 24 months after surgery. It~     allows to the physician to follow the evolution of the patient under treatment and after~     discontinuation of the treatment.~      Several data are collected during the follow-up concerning: demographics data, treatment~     including the use of off-label antibiotics for the treatment of BJI, adverse events,~     microbiology, surgeries, healing or relapse, date of symptoms, ASA score, implant or not. If~     there is an implant, the date of implantation and the number of the prosthesis infected are~     collected.~      This cohort allows to improve knowledge concerning the treatment failure and the occurrence~     of adverse events.~   "
57245|NCT02817698|"~     The investigators' project has two overarching goals. 1) The investigators will use newly~     developed positron emission tomography (PET) technology to investigate the dopaminergic~     neurochemistry of drugs of abuse including marijuana, traditional cigarettes, and cocaine,~     and 2) The investigators will extend PET technology to an additional neurotransmitter system~     - namely, the opioid-ergic system, using the same drugs of abuse.~   "
57246|NCT02817685|"~     This study is a randomized control prospective study. The aim of this study is to establish~     an all-round and convenient follow-up strategy of Chronic Hepatitis B for early detection and~     diagnosis of Hepatocellular Carcinoma (HCC), by investigating whether different surveillance~     time intervals and surveillance methods are beneficial for chronic hepatitis B and cirrhotic~     patients with different risk of HCC.~   "
57247|NCT02817672|"~     The goal of this project is to conduct a pilot study to test the utility of a Natural~     Language Processing (NLP) clinical messaging tool to improve the reach and the quality~     (fidelity and competency) of coaches providing behavioral activation (BA) strategies through~     a mobile mental health app called Personalized Real-time Intervention for Motivational~     Enhancement (PRIME). This study will improve the reach of clinicians by using a NLP-powered~     messaging tool, which will ensure fidelity to the BA model and clinicians will have access to~     real-time clinical information about their patients to guide more targeted treatment~     (competence). If successful, PRIME could operate as a cost effective tool for clinicians to~     extend their reach and an accessible treatment for the population of those struggling with~     depression.~   "
57248|NCT02817659|"~     To further understand the tolerability of glucagon.~   "
57249|NCT02817646|"~     The purpose of this study is to determine whether protein intake during the first days of~     intensive care admission, in relation to body composition at intensive care admission as~     assessed on computed tomography scans made during routine care, is are related to clinical~     outcome in critically ill patients.~   "
57250|NCT02817633|"~     This is a multicenter, open-label, first-in-human Phase 1 study evaluating the anti-TIM-3 (T~     cell immunoglobulin and mucin containing protein-3) antibody TSR-022, as a monotherapy and in~     combination with an anti-PD-1 antibody, in patients with advanced solid tumors who have~     limited available treatment options. The study will be conducted in 2 parts: dose escalation~     and cohort expansion.~   "
57251|NCT02817620|"~     The purpose of this pilot study is to assess the beneficial effect of a spirulina water~     extract (product named Spirulysat®) compared to a placebo in the blood level ratio of~     oxidized LDL / total LDL cholesterol in subjects with metabolic syndrome after 12 weeks of~     consumption~   "
57252|NCT02817607|"~     The purpose of this study is to establish techniques for evaluating breast cutaneous~     sensation at baseline and following either lumpectomy or mastectomy for breast cancer.~   "
57254|NCT02817581|"~     To validate the NEWS and rapid lactate testing for early identification of high risk [triage~     Category 3 (urgent)] patients in the Emergency Department.~      To compare qSOFA and SIRS criteria in patients in the Emergency Department.~   "
65022|NCT02715869|"~     Preconditioning (PC) of the heart occurs when brief exposure to a stimulus protects the heart~     from subsequent ischemia. PC stimulus may be (ischemic ; pharmacologic or Physical).~   "
57257|NCT02817542|"~     Background. Patients with ST-Elevation Myocardial Infarction (STEMI) and hyperglycemia on~     admission have high rates of mortality (1). The management of hyperglycemic patients during~     STEMI is unclear. We evaluate whether the thrombus aspiration (TA) before primary~     percutaneous coronary intervention (PCI) may improve STEMI outcomes in hyperglycemic patients~     (2).~      Research Design and Methods. Consecutive 990 hyperglycemic patients with first STEMI~     undergoing quantitative coronary angiography were studied. Patients were categorized in two~     groups, either treated by thrombus aspiration v/s patients treated without thrombus~     aspiration. After discharge from the hospital, all patients will be managed and followed~     quarterly for 12 months month after event, as outpatients, to perform clinical evaluation,~     routine analyses and cardiovascular evaluation. The cardiovascular endpoint collected in both~     cohorts will include cardiac mortality, all-cause mortality and hospitalization for coronary~     disease and heart failure.~      Conclusions. We will attend improved outcomes in hyperglycemic patients treated by the TA~     before PCI, as compared to hyperglycemic patients treated only by PCI.~   "
57258|NCT02817529|"~     Positive expiratory pressure (PEP) therapy is a device aiding airway clearance and secretion~     mobilization, also prevent the small airway from collapsing. The purpose of this research is~     to compare two PEP devices (Pulmonica, RC-Cornet) in stable COPD patients. Patients'~     compliance, satisfaction, 3 months and 6 months lung function test and life quality will be~     compared.~   "
57259|NCT02817516|"~     The purpose of this study is to evaluate the safety and tolerability of multiple oral doses~     of TAK-828 in healthy participants.~   "
57260|NCT02817503|"~     The purpose of the current feasibility study is to test whether the blood pressure level of~     the study patients can be effectively and safely managed according to the intensive~     antihypertensive treatment protocol. Furthermore, the study will also examine the effect of~     intensive antihypertensive treatment on the intermediate cardiovascular diseases outcomes,~     including CIMT, carotid plaques, PWV ABI, and kidney function, etc.~   "
57261|NCT02817490|"~     The Ehlers-Danlos Syndrome (SED) comprises a group of clinically and genetically~     heterogeneous, inherited connective tissue diseases. The hypermobility type is the most~     frequent. It is characterized by a generalized joint hypermobility and a hyperextension skin.~      Chronic pain syndrome is often present. Its psychological impact can be significant (anxiety,~     depression, impact on the quality of life of the patients). The disease also requires changes~     and a permanent adaptability (coping). It can lead to feelings of isolation and~     misunderstanding.~      The French association of the Ehlers-Danlos Syndromes and the rehabilitation center of the~     'Croix-Rouge Française des Massues' propose a patient education program for the patients with~     a hypermobility type SED (the PrEduSED program). This education program is open to patients~     and their caregivers located in France.~      The research hypothesis is that the PrEduSED program improves their coping and reduces~     patient anxiety at 6 months (these are the two clinical criteria on which the PrEduSED could~     have the most impact, given the results of the first sessions).~   "
57262|NCT02817477|"~     Introduction: Ketamine has been well studied for its efficacy as an analgesic agent. However,~     intranasal (IN) administration of ketamine has only recently been studied in the emergency~     setting.~      Objective: To elucidate the efficacy and adverse effects of a sub-dissociative dose of IN~     Ketamine compared to IV and IM morphine.~      Methods: A single-center, randomized, prospective, parallel clinical trial of efficacy and~     safety of IN ketamine compared to IV and IM morphine for analgesia in the emergency~     department (ED). A convenience sample of 90 patients aged 18-70 experiencing moderate-severe~     acute traumatic pain (≥80mm on 100mm Visual Analog Scale [VAS]) were randomized to receive~     either 1.0mg/kg IN ketamine, 0.1mg/kg IV MO or 0.15mg/kg IM MO. Pain relief and adverse~     effects were recorded for 1 hour post-administration.~      Primary Outcomes: The primary outcome was efficacy of IN ketamine compared to IV and IM MO,~     measured by time-to-onset (defined as a ≥15mm pain decrease on VAS), as well as time to and~     degree of maximal pain reduction.~   "
57263|NCT02817464|"~     The purpose of this pharmacodynamic and pharmacokinetic study is to identify a dose of~     TV-46046 (within the range 80 to 300 mg) that is both safe and consistent with contraceptive~     effect when injected every 6 months.~   "
57264|NCT02817451|"~     Study is to assess and confirm the adequate immunogenicity and safety profile of the Sanofi~     Pasteur's DTaP-Hep B-IPV-PRP-T fully liquid combined hexavalent vaccine administered in~     HIV-exposed uninfected infants (HIV-exposed uninfected) and in HIV-exposed infected infants~     (HIV-exposed infected).~      Primary Objectives:~        -  To evaluate the immunogenicity of the study vaccine 1 month after the 3-dose primary~          series in HIV-exposed infected and in HIV-exposed uninfected infants.~        -  To describe the persistence of all antibodies before receipt of the booster vaccination~          in HIV-exposed infected and in HIV-exposed uninfected infants.~        -  To evaluate the immunogenicity of the study vaccine 1 month after the booster dose in~          HIV-exposed infected and in HIV-exposed uninfected infants.~      Secondary Objectives~        -  To describe the safety profile after each and all doses of the study vaccine~          administered as a 3-dose infant primary series in HIV-exposed infected and in~          HIV-exposed uninfected infants.~        -  To describe the safety profile of the study vaccine administered as a booster in~          HIV-exposed infected and in HIV-exposed uninfected infants.~   "
57265|NCT02817438|"~     This study examines how online self-guided programs can improve mood and anxiety symptoms.~     These programs use exercises from Cognitive-Behavioral Therapy, which is an evidence-based~     treatment for depression and anxiety. The purpose of this study is to learn who will do best~     with the online format. Our aim is to learn for whom online self-guided interventions are~     most efficacious. This knowledge is important because it will help inform clinicians and~     patients about who might benefit from this type of intervention versus who would need the~     assistance of a therapist. More specifically, we hope to figure out who would benefit from~     solely an online intervention and who would benefit from an online intervention in addition~     to other treatment.~   "
57266|NCT02817425|"~     This study is designed to compare the three chemotherapy regimens(TEGAFOX Sequential S-1 or~     SOX Sequential S-1 or SOX non-Sequential S-1) for postoperative patients with gastric cancer,~     observe and record the efficacy and tolerance,to evaluate which regimen is better.~   "
57267|NCT02817412|"~     This study will examine the effectiveness of food response training interventions in reducing~     binge eating among adults engaged in binge eating.~   "
57271|NCT02817360|"~     Purpose and rationale The purpose of this study is to evaluate the effect of high dose~     Renin-Angiotensin System (RAS)-antagonists and beta-blocker treatment for the primary~     prevention of cardiac events in a population of patients with Type 2 diabetes mellitus (T2DM)~     with no evidence of a preexisting cardiac disease. An additional aim is to demonstrate an~     interaction between concentrations of amino-terminal pro-B type natriuretic peptide~     (NT-proBNP as a surrogate of imminent cardiac risk) and treatment effects and the economic~     impact of the intervention overall and in the biomarker stratified subgroups.~      Primary objective Superiority of high dose treatment with RAS-antagonists and beta-blockers~     compared to conventional therapy regarding the reduction of unplanned hospitalization or~     death due to a cardiac event in T2DM patients with a NT-proBNP > 125pg/ml.~      There is an additional eye-substudy for Viennese sites only. The purpose of this sub-study is~     to evaluate the effect of high dose RAS-antagonists and beta blocker treatment on early~     subclinical signs of diabetic micro-angiopathy and neuropathy. An additional aim will be the~     evaluation of the possible impact of the cardiovascular risk factor NT-proBNP on the onset~     and progression of diabetic retinopathy.~   "
57272|NCT02817347|"~     In patients with otitis media presenting with otoscopy-confirmed otorrhea who had~     tympanostomy tube insertion or tympanic perforation, to evaluate the safety, tolerability,~     and the proportion of patients with cessation of otorrhea after ear-drop administration of~     YH1177 or YH1177-D for 14 days and therefore to determine the optimal clinical dose.~   "
57273|NCT02817334|"~     Near-infrared (NIR) fluorescence imaging using indocyanine green (ICG) has been used for~     breast cancer surgery such as sentinel lymph node (SLN) mapping and breast cancer~     localization.~      In this study, our hypothesis are as following:~        1. As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure~          better outcome.~        2. indocyanine green (ICG) permitted accurate preoperative and intraoperative detection of~          the SLNs as well as nonpalpable benign brest lesion in patients with breast cancer.~   "
57274|NCT02817321|"~     This prospective, randomized study,control study aims to compare the analgesic effect,opioids~     consumption,quality of recovery,length of hospital stay and incidence of chronic pain,et al.~     between single-injection TPVB(thoracic paravertebral block) , single-injection TPVB~     +continuous TPVB and intravenous patient-controlled analgesia (IPCA) alone in patients~     undergoing hepatectomy with right J-shape subcostal incision.~   "
57275|NCT02817308|"~     Ductal adenocarcinoma of the pancreas is the fifth leading cause of cancer related deaths in~     the European Union. Tumor markers CA19-9 and carcinoembryonic antigen are important~     components in decision making and follow-up of patients diagnosed with this disease.~      These tumor markers were found to be elevated not only in the serum but also in other body~     fluids in patients with malignant lesions of the parotid gland and the urinary tract. The~     authors have described in a previews small preliminary study a positive and a strong linear~     correlation between the levels of CA19-9 in urine and saliva with those presented in the~     serum of patients with ductal adenocarcinoma of the pancreas. The current study seeks to~     enlarge the study population to confirm the previous results and standardize the measured~     levels of CA19-9 in these body fluids.~   "
57276|NCT02817295|"~     an examination of the different aspects of bariatric surgery in elderly in comparison with~     non-elderly patients.~   "
57277|NCT02817282|"~     Hand hygiene (HH) appears to be a simple, non-complex procedure to prevent~     healthcare-associated infections (HAIs), implementation in daily routine is difficult. The~     residential setting and specific population pose challenges to optimal HH compliance. This~     study aims to develop and to evaluate an evidence based multi-component implementation~     strategy aimed at the promotion of HH in Dutch nursing homes(NHs). A strategy to improve HH~     compliance in Dutch NHs will be developed. This strategy addresses the specific barriers and~     facilitators of NHs' infrastructure, healthcare workers (HCWs) and socio-cultural setting.~     The strategy will be tested in a stepped wedge cluster randomized design which is based on a~     random sequential roll-out of the implementation strategy to all participating NHs (n=20) for~     comparison. Data are collected during six consecutive four month periods with an initial~     baseline period for all NHs.~      During each period 1200 opportunities for HH are observed, using the gold standard of direct~     and unobtrusive observations, according to the Five Moments for HH of the World Health~     Organization. HAIs incidence densities, collected in the sentinel surveillance network for~     infectious diseases in nursing homes (SNIV), will be evaluated in parallel.~      A multi component implementation strategy, combining activities aimed at individual HCWs,~     teams and the organization will be used. The individual level includes education, skills,~     action planning, reminders and feedback. The team level includes activities that focus on~     social influence, strengthening of leadership by gaining active commitment and initiative of~     ward management. The organizational level addresses the structural context and institutional~     management support.~      To assess the cost implications of the CHANGE strategy, an economic evaluation will be~     conducted from a healthcare perspective. The cost-effectiveness of improved HH, defined here~     as the costs for the CHANGE strategy minus less costs for treating infections, divided by the~     difference between HAIs before and after the intervention period, will be calculated. A~     process evaluation will be performed during and after the intervention to investigate the~     feasibility of the implementation strategy and to illuminate the mechanisms and processes~     responsible for the results and their variation within the NHs.~   "
57278|NCT02817269|"~     The first aim of the study will be to identify the most common ReP pattern and compare its~     coincidence with that described by Travell and Simons. Second, the study aim will be to~     verify whether there are any significant differences by sex and types of technique used in~     regard to the ReP pattern of TrP 2 of the infraspinatus muscle, an area described as more~     sensitive.Finally, the third aim of the study will be to determine whether deep dry needling~     will evoke the LTR and ReP more easily than manual palpation.~   "
57293|NCT02817074|"~     Phase III randomized controlled trial designed to test the effects of a 3-year intervention~     of the MIND diet (Mediterranean-DASH Intervention for Neurodegenerative Delay) on cognitive~     decline and brain neurodegeneration among 600 individuals 65+ years without cognitive~     impairment who are overweight and have suboptimal diets.~   "
57294|NCT02817061|"~     Aim: Investigate whether transcranial photobiomodulation (tPBM) using near-infrared light~     exposure to the head, can improve frontal lobe executive function, working memory and overall~     mood in normal volunteer participants.~      Hypothesis: The investigators predict that tPBM will increase cognitive functioning, as~     measured by Cambridge Cognition cognitive testing in study subjects.~   "
57295|NCT02817048|"~     Chest tube placement after thoracoscopy surgery had been generally accepted as routine~     procedure for removal of the residual intrapleural fluid and air, however, it would cause~     post-operative pain, prohibit ambulation after surgery, and prolong the hospital stay.~     According to the recent studies, omission of chest tube placement after minor thoracoscopic~     procedures (such as pulmonary wedge resection) had been safe and feasible, and it also~     reduced the post-operative pain and shortened the hospital stay. We will conduct a~     prospective randomized trial in National Taiwan University Hospital.~   "
57279|NCT02817256|"~     Bariatric surgery is emerging as an essential treatment option for the management of obesity~     and its associated comorbidities. Many patients present for surgery have pre-existing low~     blood vitamin levels, thus all bariatric surgical procedures compromise nutrition to varying~     extents, and may present potential threat of micronutrient deficiencies. Therefore, long term~     nutritional monitoring and follow-ups are vital components of all bariatric surgical~     patients. However, there are no current standard practices in United Arab Emirates (UAE) for~     the biochemical monitoring and replacement of essential micronutrients in patients undergoing~     bariatric surgery particularly the most performed Sleeve Gastrectomy. Medical practice~     guidelines recommend nutritional care however, the dose and route of administration~     supplementation after surgery based on randomized controlled trials is not yet established.~     Till tow no scientific study has been performed on monitoring vitamins and minerals levels~     following bariatric surgery among UAE population. Therefore, present study is aimed to~     determine the dose and route of administration of vitamins and minerals in improving the~     micronutrient deficiencies post-operatively. Two standard different dosage forms (oral~     /parenteral) of vitamins and minerals will be given to the patients who had undergone sleeve~     gastrectomy at Tawam Hospital. The dosages of the supplementations are within the~     international recommendations and patients will be followed up closely for a period of one~     year. The effect of nutritional deficiencies on micronutrient level and quality of life (QOL)~     will be assessed. This will help the medical practitioners to prove the optimal possible~     nutrition for patients.~   "
57280|NCT02817243|"~     The purpose of the study is to investigate the potential interaction between multiple oral~     doses of SP2086 and a single oral dose of Simvastatin in healthy adult volunteers.~   "
57281|NCT02817230|"~     In this study, the investigators will determine whether patients with elevated levels of LDL~     are characterized by specific epigenetic changes in circulating cells of the innate immune~     system, compared to control subjects with healthy levels of LDL and whether regular statin~     treatment influences these changes.~   "
57282|NCT02817217|"~     The purpose of the study is to investigate the potential PK interaction between SP2086 and~     Valsartan after multiple oral doses treatment in healthy male volunteers.~   "
57283|NCT02817204|"~     The purpose of this study is to determine the effect of aerobic exercise training on~     microcirculation rarefaction in Chinese young male primary hypertensive patients stage 1.~     Hypertension is one of the most common world-wide chronic diseases, and it is showing a~     growing younger trend, which with mild blood pressure elevated would not be diagnose in time~     until blood pressure raises up or symptoms show up (Mild blood pressure indicates blood~     pressures ranging from 140 to 159 mmHg systolic and/or 90 to 99 mmHg diastolic). However,~     cumulative evidences prove that microvascular rarefaction exist in hypertensive patients with~     even primary hypertension stage 1. Exercise prescription is gathering great importance in~     preventive health. Aerobic exercise, especially, has the potential to diminish blood pressure~     values, and aerobic exercise can promote angiogenesis in coronary heart disease. Notch~     signaling plays an important role in vascular formation and maintenance. However, there is no~     prospective, randomized, controlled, clinic trial to investigate the effect of exercise on~     microcirculation rarefaction in hypertension. In summary, investigators propose a hypothesis~     that aerobic exercise might not only have a blood pressure lowing effect but also improve~     microcirculation rarefaction in Chinese male adults with primary mild hypertension. For that,~     subjects will be enrolled for one pre-intervention cardiopulmonary exercise test (CPET) and~     then randomized in aerobic exercise intervention group and control group (only health~     education), the intervention will be carried out by Cycle Ergometer, the protocol consists of~     3 sessions a day: 3 minutes Warm up, 45 minutes Resistance Exercise at 75% of HRmax; 10~     minutes Recovery. Thus 58 minutes a day and 5 days a week (about 2000kcal) and 12 weeks in~     total. Prior and after all intervention sessions (12 weeks), nail fold capillary microscopy~     and retinal capillary Optical Coherence Tomography(OCT) angiography will be assessed, as well~     as 24h blood pressure monitoring, echocardiography, forearm blood flow and reactive hyperemia~     by venous occlusion plethysmography (FMD), PWV, central arterial pressure, RHI with Endopat,~     also the quantification of endothelial progenistor cells(EPCs) separated from peripheral~     blood.~   "
57284|NCT02817191|"~     The purpose of the study it to compare the effects of Holy-Comod and Tears Naturale Forte on~     ocular surface and tear inflammatory mediators in patients after Phaco+IOL.~   "
57285|NCT02817178|"~     The investigators recently identified promiscuous HLA-DR-derived epitopes from the human~     telomerase reverse transcriptase (TERT) called universal cancer peptides (UCP), to study~     tumor-specific CD4+ T cell responses.~      The investigators found high frequency of naturally occuring UCP-specific TH1 cells in long~     term survival of metastatic colorectal cancer (CRC) previously treated by 5 fluoro-uracil~     -oxaliplatin (Folfox) +/- bevacizumab regiment (Godet et al. OncoImmunology 2012 and~     unpublished data).~      Epitopes-CRC02 is a French prospective multicenter study which will evaluate the post~     chemotherapy and post surgery modulation of host tumor-specific CD4 TH1 cell responses in~     metastatic colorectal cancer patients and their correlation with progression-free survival.~   "
57286|NCT02817165|"~     In North America, one of the most common reasons for hospitalization in previously healthy~     children is for the treatment of infections with antibiotics. This study will determine if,~     in previously healthy children hospitalized and prescribed intravenous (IV) antibiotics, the~     co-administration of a probiotic milk product containing good bacteria, is safe and effective~     for reducing AAD, as compared to a placebo (identical appearing milk product). This will be a~     two-center, randomized, masked, placebo-controlled clinical trial. The results of this study~     will help inform clinicians and families on the use of probiotics in the prevention of AAD, a~     common side effect of antibiotic use among hospitalized children.~   "
57287|NCT02817152|"~     The aim of this study was to investigate the local effect of adjunct low-level laser therapy~     (LLLT) for the treatment of moderate to severe chronic periodontitis in type 2 diabetic~     patients.~   "
57288|NCT02817139|"~     This study is a pilot, double-blind, placebo-controlled, randomized trial aiming to compare~     the effects of transcranial direct current stimulation in Chronic Migraine.~   "
57289|NCT02817126|"~     The purpose of this study is to evaluate the safety and oncological feasibility of~     robot-assisted surgery for mid/low rectal carcinoma compared with laparoscopic surgery.~   "
57290|NCT02817113|"~     NC-6004 is a polymeric micelle containing cisplatin as an active moiety. The nanoparticle~     provides sustained release of the active moiety and utilizes the enhanced permeability and~     retention (EPR) effect to target release of platinum to tumors. This Phase I study aims to~     establish a recommended dose (RD) for the triplet combination of NC-6004 plus 5-FU and~     cetuximab as first-line treatment in patient with recurrent and/or metastatic squamous cell~     carcinoma of the head and neck for further clinical study development.~   "
57291|NCT02817100|"~     This study is a first in human study that will investigate the safety, tolerability and~     pharmacokinetics of ascending single doses of BAY1817080 using a placebo controlled,~     randomized, single center design. In addition the influence of itraconazole and food on the~     pharmacokinetics of BAY1817080 will be investigated.~   "
57296|NCT02817035|"~     To make these definitions of neural inspiratory time (Ti) and expiratory delay clearly.The~     present study was undertaken to examined the physiological signals of patients and healthy~     subjects during spontaneous breathing and noninvasive mechanical ventilation.~   "
57297|NCT02817022|"~     Enrolled neonates will be provided routine supportive care as per existing neonatal intensive~     care unit (NICU)protocols. This will be carried out in the initial 6 months (0-180 days) of~     study commencement. This group will serve as control group (group A). During subsequent 6~     months (181-360 days) of the study period, enrolled neonates fulfilling the inclusion~     criteria will be provided routine supportive care and the components of developmentally~     supportive care (DSC).~   "
57298|NCT02817009|"~     Childhood obesity is a contributing factor to health complications such as diabetes, heart~     disease, high blood pressure, cancer and asthma. It is of particular concern among Hispanic~     populations in the United States as that group has the fastest growing childhood obesity~     rate. Nearly two in five Hispanic children ages 2 to 19 are overweight or obese. This program~     aims to test whether it is beneficial to routinize a multi-disciplinary pediatric weight~     management program within the highest volume clinic (NYU-LFHC Women, Adolescents and~     Children), and to add a home-visit component to reinforce teaching on food selection and~     preparation. The intervention will include 27-hour intervention session which will be~     distributed into 12-session series over a 3 month period. The program will target Hispanic~     children between the ages of 9 and 11 with a Body Mass Index (BMI) between the 95th and 99th~     percentiles. To assess the effectiveness of this program, the investigators propose to~     conduct a general prospective study using randomized pre-test and post-test control group~     design with minimal risk for participants.~   "
57299|NCT02816996|"~     The goal of this study is to find the effect of holding a patient's hand on anxiety and pain~     during dermatologic procedures.~   "
57300|NCT02816983|"~     Castration-resistant prostate cancer patients with rising prostatic specific antigen (PSA)~     are eligible for this study. 11C-Choline PET/CT will be used to identify metastatic lesions.~     Patients with <=3 metastatic lesions will receive stereotactic body radiotherapy (SBRT) as~     definitive treatment. Blood draws will be taken to monitor the development of anti-prostate~     cancer immunity~   "
57301|NCT02816970|"~     An open label randomized, single dose, two-way crossover bioequivalence study to determine~     the bioequivalence of Vildagliptin from Gliptus 50 mg tablet (EVA pharma, Egypt) and Galvus~     50 mg tablet (NOVARTIS PHARMA, GERMANY) in Healthy Human Volunteers Under Fasting Condition~   "
57302|NCT02816957|"~     Evaluate the therapeutic effects health benefits, and immunological effect of Nigella sativa~     in children with beta thalassemia major.~   "
57303|NCT02816944|"~     The purpose of this study is to evaluate the safety and efficacy of endoscopic~     ultrasonography (EUS) guided laser ablation liver, pancreas, and retroperitoneal tumors, the~     investigators used preoperative and postoperative US/CEUS/CT/MRI to assess lesions, and~     laboratory tests including the tumor markers to evaluate the general condition of patients.~     Intraoperative US/CEUS/CT would be applied to monitor ablation lesions.~   "
57304|NCT02816931|"~     Multi-drug resistant tuberculosis (MDR-TB) is steadily increasing world-wide, urging for the~     need of improved treatment strategies. In order to protect the few available drugs that are~     left, ensuring adequate plasma concentrations of the drugs are important. Individualized~     therapy using plasma drug concentrations and minimal inhibitory concentration (MIC)~     determination may be of importance (1). The plasma drug concentrations and the MICs of the~     second-line drugs will be compared, aiming at increasing the knowledge about~     pharmacokinetic/pharmacodynamic (PK/PD) indices in the treatment of MDR-TB. In the future,~     the aim is an individualised therapy, where sub-therapeutic drug concentrations can be~     adjusted by the use of therapeutic drug monitoring (TDM). TDM in the treatment of MDR-TB may~     improve clinical outcome for the patients, but plasma concentrations must be assessed~     together with clinical and microbiological factors (2).~      In this observational study the hypothesis is that the ratio between drug concentrations and~     MICs of the anti-tuberculous drugs, are correlated to the time to sputum culture conversion,~     the bacterial load measured as time to positive liquid culture (TTP) and clinical outcome.~     Consenting adult patients with pulmonary MDR-TB patients in China will be recruited.~     MIC-determination of Mycobacterium tuberculosis will be performed in BACTEC 960 MGIT and drug~     concentration will be determined at 2, 4 and 8 weeks after treatment initiation using liquid~     chromatography tandem mass spectrometry (LC-MS/MS), simultaneously assessing Dried Blood Spot~     (DBS) as a bio-sampling method. Sputum cultures will be obtained regularly throughout the~     treatment to measure the time to culture positivity (TTP). Clinical follow up according to~     WHO criteria will be performed at the end of treatment completion.~   "
57305|NCT02816918|"~     intends to evaluate the feasibility and security issues of univent bronchial blockers outside~     the single lumen endotracheal tube for one- lung ventilation in left thoracic surgery~     patients.~   "
57306|NCT02816905|"~     This study aims to compare the effects of topical (Rimexolone versus Dexamethasone) on the~     IOP in children under 13 years of age who underwent bilateral strabismus surgery, and to~     compare the effects of topical (Rimexolone versus Fluorometholone) on the IOP in the children~     under 13 years of age who underwent bilateral strabismus surgery.~   "
57307|NCT02816892|"~     This study aims to investigate Serum Tenascin C levels in patients with acute symptoms~     relating to a known or newly diagnosed aortic aneurysm in emergency department and reveals~     the possible role of Tenascin C in the development of the disease.~   "
57308|NCT02816879|"~     This clinical trial compares three anal cytology collection procedures (collected at a single~     visit) in men who have sex with men (MSM). It also compares two different tests for human~     papilloma virus, the virus that causes high grade anal dysplasia, which is thought to occur~     before anal cancer. This study may help doctors develop better screening for high-grade anal~     dysplasia in MSM in order to identify those who need to return for additional screening and~     treatment.~   "
57309|NCT02816866|"~     The main purpose of this study is to research the comparative effectiveness of two potential~     models of health care to deliver preventive services and chronic care management to the~     growing population of adult and pediatric survivors of childhood cancer. The central~     hypothesis is that survivorship care delivered by a subject's primary care doctor after the~     subject is empowered with individualized follow-up recommendations prepared by a cancer~     survivor specialist is similar to care provided in a specialty survival clinic.~   "
57311|NCT02816840|"~     The trial is to explore new and effective techniques in the treatment of prostate cancer and~     evaluate the role of PET-CT / MRI played in radiotherapy. Intensity modulated radiation~     therapy(IMRT) is adopted with all patients and the efficacy assessment for the prostate~     cancer will be examined with PET / CT or CT in three months after radiotherapy.~   "
57312|NCT02816827|"~     The current study is design to asses the effect of E-AG-01/ E-AG-02/ E-AG-03 on mental~     alertness as compared to placebo.~   "
57313|NCT02816814|"~     Healthy lifestyle, based on healthy diet and exercise, is a key factor to prevent the most~     common menopausal disorders and chronic diseases to which women are more exposed during this~     life stage. Therefore, menopausal women may represent a target for evaluating the~     effectiveness of nutritional intervention studies based on protective diets against the~     common metabolic diseases, such as metabolic syndrome, obesity and hepatic steatosis.~      Lipidomics aims to study the lipid molecules in a dynamic way and allows to define not only~     structure and functions of a set of lipid species present in an organism, but also the~     changes that occur during cell metabolism under physiological and pathological conditions in~     order to understand their role as part of the complex functional balance of a living~     organism.~      Quantitative and qualitative determination of fatty acids profiles in cell membranes allows~     to follow their molecular changes occurring for intrinsic and extrinsic metabolic causes,~     such as inflammation, stress, nutrition.~      Scientific evidence has shown that, for nutritional studies, the most representative cell is~     the erythrocyte, which is a biomarker of an individual's general state of health. In fact,~     the evaluation of the fatty acid composition contained in the membrane of red blood cell,~     which has an half-life of four months, allows to follow the nutritional status of a subject~     and to acquire information about his eating habits, with special reference to fat~     consumption.~      The higher intake of omega-3 fatty acids is associated with a decreased inflammatory state~     which is often altered in patients with metabolic diseases, hepatic steatosis and obesity.~      Overweight or obese women in menopause for at least 12 months, aged between 45 and 68 years,~     will be submitted at baseline to blood samples for lipidomic profile, blood tests, medical~     examination with blood pressure and anthropometric measurements (weight, height, waist and~     hip circumferences), indirect calorimetry and bioimpedentiometry. Participants will be~     randomly assigned to diet with extra virgin olive oil (LoVE DIET) or to diet riched in~     omega-3 fatty acids (LωVE DIET) for four months. During the treatment period, women enrolled~     will undergo medical examination and dietary control to assess the adherence to the dietary~     pattern, collecting anthropometric measurements, indirect calorimetry and bioimpedentiometry~     after 4 and 16 weeks as well as blood samples after 16 weeks.~      The results will be analyzed using appropriate statistical tests. All patients will be made~     to sign an informed consent.~   "
57314|NCT02816801|"~     In this study, effectiveness of an internet based intervention (Butler 2.0) for elderly is~     tested. Participants (n= 60) will be randomly assigned to two different groups (intervention~     vs. waitlist). Outcomes in terms of loneliness and quality of life will be assessed at pre-,~     post (6 weeks) and follow-up (3 months).~   "
57315|NCT02816788|"~     In partnership with SARI Therapeutic Riding (SARI TR), Brescia University College, at the~     University of Western Ontario, will study the use of Equine Assisted Therapy (EAT) for~     military veterans diagnosed with Post-Traumatic Stress Disorder. Data will be collected~     through tests and questionnaires, and follow-up interviews with participants. It is expected~     that after a series of 10 EAT sessions, the social, emotional and psychological well-being of~     participants will be improved and PTSD symptoms alleviated.~   "
57316|NCT02816775|"~     The intubation response to airway manipulation during direct laryngoscopy can cause~     hypertension, dysrhythmias and increased intracranial and intraocular pressures. This intense~     physiological response is proven to be associated with adverse outcomes especially in elderly~     patients. Increased QT dispersion is associated with increased risk of ventricular~     arrhythmias, which may increase the risk of sudden death caused by life-threatening~     arrhythmias. McGrath Videolaryngoscope would generate a lesser haemodynamic response than the~     conventional method of direct laryngoscopy. The objective of this study was to compare the~     hemodynamic response and QT during following tracheal intubation, using videolaryngoscope or~     direct laryngoscope to intubation. The postoperative airway morbidities is the investigators~     secondary outcome.~   "
57317|NCT02816762|"~     Objectives: Main objective: To assess the effect of 12 months of CPAP treatment added to~     conventional drug treatment on the albuminuria in patients with diabetic nephropathy and~     obstructive sleep apnea (OSA). Secondary objectives: To evaluate the effect of CPAP treatment~     on the estimated glomerular filtration rate of patients with diabetic nephropathy and OSA;~     determine the additional longterm CPAP effect on glycemic control, insulin resistance, lipid~     profile, health-related quality of life and biomarkers of cardiac function, inflammation,~     oxidative stress, sympathetic tone and appetite-regulating hormones in patients with diabetic~     nephropathy and OSA; and to identify the subgroup of patients with diabetic nephropathy and~     OSA in which 12 months of treatment with CPAP achieve a more pronounced reduction in~     albuminuria.~      Methodology: Randomized, multicenter, non-blinded, parallel groups, conventional~     treatment-controlled trial of 12 months of duration.~      Subjects will randomize to conventional dietary and pharmacological treatment or conventional~     dietary and pharmacological treatment plus continuous positive airway pressure (CPAP). Study~     subjects: Subjects 18 to 80 years with overweight or obesity and a clinical diagnosis of~     diabetic nephropathy, increased urinary albumin/creatinine ratio of 30 mg/g and an estimated~     glomerular filtration rate >20 ml/min/1.73 m2, and treatment with stable doses of~     angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs) or~     anti-aldosterone drugs in the last four weeks. Efficacy variables:~      urinary albumin/creatinine ratio and estimated glomerular filtration rate; glycosylated~     hemoglobin (HbA1c); fasting glucose and insulin; homeostatic model assessment (HOMA) and~     QUICKI indices; total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides; Troponin~     I, proBNP, homocysteine and high-sensitivity C-reactive protein; systemic biomarkers~     (inflammation [IL-6, IL-8 and tumor necrosis factor-α], oxidative stress [8-isoprostane],~     endothelial damage [endothelin, VCAM-1 and ICAM-1], sympathetic activity [neuropeptide Y] and~     appetite-regulating hormones [leptin and adiponectin]) and clinical questionnaires: short~     form (SF)-12, EuroQoL and iPAQ.~   "
57318|NCT02816749|"~     This is a prospective study of participants with diabetic foot ulcers who will receive either~     maggot debridement therapy (MDT) or conventional dressing therapy (CDT). Wound healing time~     is the main outcome measure to compare the clinical efficacy of these two therapies. The~     investigators developed a hypothesis that MDT could achieve remarkable shorter time and~     better healing rate for wound closure when compared with CDT.~   "
57319|NCT02816736|"~     The primary objective of the study is to determine whether, in patients with symptomatic,~     advanced heart failure due to left ventricular systolic dysfunction, treatment with LCZ696~     for 24 weeks will improve Pro-B-type Natriuretic Peptide (NT-proBNP) levels, which reflect~     hemodynamic and clinical status, compared to treatment with valsartan.~   "
57320|NCT02816723|"~     Evidence shows the positive effects of Brain Health & Wellness classes in younger~     individuals. The proposed study investigates the usefulness of these classes in older~     Veterans aged 50-85. We hope to show that such classes can lead to improvements in both~     thinking skills as well as stress levels.~   "
57321|NCT02816710|"~     To evaluate efficacy of different intravitreal Conbercept injection therapy in the treatment~     of vitreous hemorrhage (VH).~   "
57322|NCT02816697|"~     The proposed study plans to adapt and study the implementation and effectiveness of~     integrating Clinical and Community Effort Against Secondhand smoke Exposure (CEASE) into the~     thoracic oncology setting using mixed methods.~   "
57497|NCT02814409|"~     The principle research question is: in patients with acute ischaemic stroke eligible for~     intravenous (IV) thrombolysis, is tenecteplase superior in efficacy to alteplase, based on~     functional outcome as assessed by modified Rankin Scale distribution at day 90?~   "
57323|NCT02816684|"~     Among children, social anxiety is a common, severe and chronic disorder. Social Effectiveness~     Therapy for Children (SET-C) is an empirically supported treatment with significant potential~     to impact the lives of children with this severe and chronic disorder. The proposed~     Pegasys-VR™ system will distinctly enhance its utility, as it will allow dissemination to a~     broad variety of clinical settings including schools as well as traditional outpatient~     clinics. Its use for the treatment of social skills deficits will offer a superior solution~     for mental health personnel, solving many of the resource and logistic barriers that they~     currently face. The final product will address cost and practical issues by disseminating an~     empirically-supported treatment that was rigorously built and tested. Using VE will make the~     traditional social skills therapy programs program cost-effective and patient-centric,~     allowing even clinicians with little background/training in behavior therapy to have tools~     not typically available to them.~   "
57324|NCT02816671|"~     The primary purpose of this prospective, open-label, multi-center observational registry with~     all-comers enrollment is to report on the use of the MicroCutter Stapler in a real world~     setting in thoracic surgical procedures. Procedures may be open or video assisted thoracic~     surgery (VATS) including robotic surgical cases. Clinicians will provide objective and~     subjective evaluation of the use of the stapler in their procedures.~   "
57325|NCT02816658|"~     Inguinal hernia repair is one of the most commonly performed general surgery operations.~     However, to date, the ideal surgical approach for inguinal hernia surgery. The investigators~     therefore, propose a randomized controlled trial comparing laparoscopic inguinal hernia~     surgery repair to robotic inguinal hernia repair surgery.~      The investigators hypothesize that the robotic approach to inguinal hernia repair will result~     in improved post-operative outcomes compared to traditional laparoscopic inguinal hernia~     repairs.~      Specific Aim #1: To determine if the robotic approach will result in a significant reduction~     in postoperative pain and earlier return to full function when compared to a laparoscopic~     inguinal hernia repair.~      Specific Aim #2: To perform a cost analysis to determine the financial implications of~     performing a robotic versus a laparoscopic inguinal hernia repair.~      Specific Aim #3: To determine the effect of surgeon reported ergonomics when performing~     laparoscopic versus robotic inguinal hernia repairs.~      Specific Aim #4: Evaluate the long term hernia recurrence rates associated with laparoscopic~     versus robotic inguinal hernia repairs.~   "
57326|NCT02816645|"~     The study of non-invasive and reliable biomarkers to track progression of Parkinson's disease~     (PD) is essential while disease-modifying treatments are being developed. Many clinical~     biological or imaging biomarkers have been tested but no gold standard has been found as of~     yet. Among these, Magnetic Resonance Imaging (MRI) relaxometry using R2* measurement (R2* =~     1/T2*), which is a validated marker for estimating brain iron concentration, appears to be an~     attractive technique because its safety, rapidly measured in clinical conditions and its ease~     to ensure individual longitudinal follow-up. Current data of cross sectional studies of R2*,~     which have shown an iron increase in Substantia Nigra (SN), led to suppose that it could be a~     biomarker of disease vulnerability. Recently, the investigators have conducted the first~     longitudinal follow-up of R2* (1.5 T MRI), which showed a rapid R2* increase in both parts of~     the SN and in the caudal putamen. We propose, here, a multicenter prospective study of~     one-year cohort follow-up of R2* variations (ΔR2*) in three regions of interest (ROIs) (the~     SN, the Ventral Tegmental Area (VTA) and the Putamen) of 160 patients with PD, using a 3~     Tesla MRI, to evaluate the potential interest of R2* as a biomarker of disease progression.~     The variation of R2* (ΔR2*) will be correlated with clinical markers of disease progress,~     non-motor symptoms. 80 healthy controls subjects will also be included to assess the effect~     of aging on cerebral physiological iron levels.~   "
57327|NCT02816632|"~     The purpose of this research is to identify and probe the neural networks involved in~     feedback processing. It aims at translating this knowledge to clinical populations in which~     this network is disrupted or compromised.~      It includes two studies: 1) with fMRI in healthy subjects to identify the neural bases of~     feedback processing on decision making using different types of feedback (neutral, social and~     monetary) presented either infra- or supra-laminary and 2) probing the role of one structure,~     the anterior cingulate cortex, using Galvanic Vestibular Stimulation (GVS) in healthy~     subjects. The interventional part consists in the administration of Galvanic Vestibular~     Stimulation (GVS), which by means of small intensity currents activates the vestibular organs~     and subsequently vestibular-related brain areas. GVS will be delivered to healthy~     participants engaged in behavioural tasks requiring the processing of feedbacks of different~     nature (e.g. social or monetary feedbacks)~   "
57328|NCT02816619|"~     There is growing interest for physical activity in Parkinson's disease in order to improve~     mobility and function of these patients. It seems from previous studies that difficulty,~     intensity and specificity of physical exercises are important parameters conditioning the~     effect of physical activity on cerebral plasticity and clinical improvement.~      Thus, the aim of this study is to evaluate the benefits of a Personalized Physical Activity~     coaching program, including scheduled and frequent follow up associated with progressive~     readaptation of exercise intensity depending on individual performances (during 3 months),~     versus free practice of physical activity in Parkinson's disease.~   "
57329|NCT02816606|"~     Following recent advances in the understanding of successful anterior cruciate ligament (ACL)~     reconstruction, three important factors have been identified: femoral tunnel positioning,~     femoral tunnel aperture shape, and native remnant preservation. Accordingly, the researchers~     have adapted their technique to address these goals. This study is designed to assess the~     feasibility of evaluating these graft characteristics, on post-operative imaging, and the~     ability to show potential improvements with the researchers' technical changes. The study~     plans to use three-dimensional computer tomography (3D-CT) and magnetic resonance imaging~     (MRI) to assess these properties and the integration of the graft. In addition, the~     researchers will use their routine functional scores to monitor the patients' outcome. If~     successful, the research team hope to set-up a randomised control trial of this alternative~     technique versus conventional methods with assessment through the same imaging mediums and~     clinical follow-up.~   "
57330|NCT02816593|"~     To evaluate the efficacy, safety and impact on quality of life related to oral health of home~     and office tooth whitening techniques in young individuals.~   "
57331|NCT02816580|"~     Epidemiological data from Europe have shown that around 30% of subjects aged over 65 years of~     age are pre-frail, and 15% are frail. Recent research has demonstrated that identifying~     frailty and implementing preventive measures can help to slow cognitive decline. Screening~     and treating frailty seem to be a good start towards preventing dependency.~      On the premise that this frailty is the result of more pronounced tissue alterations in~     certain elderly subjects, assessment of post-translational modification derived products~     (PTMDP) represents an innovative evaluation method. These include advanced glycation~     end-products (AGE), and carbamylation-derived products (homocitrulline). Indeed, the~     intensity of these modifications increases with ageing, and assessing the products resulting~     from these alterations could show the existence of differences according to frailty status.~     This would make it possible to adapt treatment accordingly in elderly subjects.~   "
57332|NCT02816567|"~     The objective of the study is to describe factors influencing abdominal compliance during~     laparoscopic surgery, including neuromuscular blocking agents (NMBA). The use of NMBA is~     randomized and blinded from the surgeons and the anesthesiologist. The abdominal compliance~     is measured by pressure/volume relationship.~   "
57333|NCT02816554|"~     A dose escalating study with 3 different dosing regimens of the studied vaccine (JECEVAX-~     VABIOTECH-Vietnam) and a licensed vaccine (JEVAX-VABIOTECH-Vietnam) is conducted in~     Vietnamese children, aged 9 to 24 months to assess the safety and immunogenicity. Two hundred~     children are enrolled and randomly assigned into 4 groups (50 children/group), each of which~     receive 2 doses of study / control vaccine subcutaneously, at 10-12 days interval. Safety~     issues included immediate reaction at the site of injection and systemic reaction within 30~     min of administration, solicited and unsolicited adverse events occurs from the first dose to~     30 days after second dose; SAE (from start of first dose to 30 days after second dose), blood~     cell count, urea, ALT, AST. Immunogenicity outcomes include seroconversion of neutralizing~     antibodies (blood samples are taken prior to 1st dose and 20-22 days post 2nd dose).~   "
57334|NCT02816541|"~     The Pilates Method (PM) has been widely used in the daily practice of many professionals. It~     is well known that anticipatory postural adjustments (APAs) have a strong relation with the~     improvement in performance through motor control improvement. However, no studies have~     investigate the PM exercises performed with pelvis in different positions on the improvement~     of performance, APAs and these influences on motor control. This study aims to compare the~     effects of practicing a single session of Pilates-based therapeutic exercises with posterior~     pelvic tilt and neutral position of the pelvis on the APAs of elderly subjects.~   "
57335|NCT02816528|"~     France is a country strong consumer of antibiotics in Europe, specially in primary care.~      Outpatient antibiotic use represents around 90% of total antibiotic use and prescriptions~     come mainly from general practitioners. A literature review of antibiotic stewardship in~     primary care show that there is no evaluation of interest of giving information about~     consumption of antibiotics and bacterial resistance to general practitioners. The objective~     of this study is to demonstrate that practitioners implicated in the followed of consumption~     of antibiotics and bacterial resistance around their geographical area of practice could~     change and improve their practices in good use of antibiotics.~   "
57336|NCT02816515|"~     This is a 3-week, non-interventional, observational study of patients undergoing chemotherapy~     (sutent) designed as a three-arm parallel study. In this study, the efficacy of Ectoin~     containing mouthwash given prophylactically for the prevention of mucositis in patients~     before radio- and/or chemotherapy; as well as during radio- and/or chemotherapy for patients~     with mucositis compared to standard treatment should be investigated. The study doesn't~     intervene with routine treatment strategy.~   "
57337|NCT02816502|"~     This study investigates the clinical and neural effects of stress management skill building~     programs for young adults with childhood adversity. The investigators will recruit a total of~     60 young adults (21-35 years old) who will be randomized into two different stress management~     skill building programs, both of which are 8 weeks long. MRI and psychological assessments~     will be acquired from all subjects before and after the intervention programs in order to~     investigate changes in clinical symptoms (such as depression, anxiety and stress) and~     hippocampus structure and function as well as other neural changes.~   "
57338|NCT02816489|"~     Labial alveolar bone thickness and apical root resorption changes associated with~     self-ligating versus conventional brackets.~      The aim of this study will be to compare labial alveolar bone thickness and apical root~     resorption changes associated with self-ligating versus conventional brackets.~   "
57339|NCT02816476|"~     This is a Phase II, single-arm, multicentre study of Daratumumab (16mg/kg IV route) in adult~     patients with Light-Chain (AL) Amyloidosis who are not in VGPR or better after previous~     treatment. A sample size of 40 patients who meet all eligibility criteria will be enrolled to~     receive study treatment. Patients will receive treatment until either disease progression or~     toxicity has occurred with a maximum planned of six 28-day cycles.~      Daratumumab will be administrated every week for the first 2 cycles then. every 2 weeks from~     cycle 3 through cycle 6.~      Patients will also receive best supportive care (BSC) to mitigate Daratumumab side-effects,~     and to address underlying Amyloidosis, including blood product transfusions, antimicrobials,~     and (as appropriate) growth factors including granulocyte colony-stimulating factors for~     neutropenia, erythropoietin for anaemia, and/or transfusions for thrombocytopenia~   "
57340|NCT02816463|"~     The purpose of this study is to determine whether the leak pressure of the recently~     introduced laryngeal mask airway, Ambu AuraGain performs superior to the established~     laryngeal mask LMA Supreme in surgical patients undergoing general anesthesia. This leak~     pressure is the pressure at which a gas leaks around the airway, which is a key marker of~     efficacy and safety of its use; a higher leak pressure suggests a better seal between the~     artificial airway and patient's airway.~   "
57341|NCT02816450|"~     The aim of this study is to determine the influence of changes in water intake on changes in~     cognitive function among preadolescent children. Further, the proposed work will determine~     the relationship between urinary markers of hydration process and cognitive function. We~     hypothesize that an increase in water intake will result in greater cognitive performance. In~     addition, improvements in hydration demonstrated by lower urine concentration will be~     correlated with greater cognitive performance.~   "
70305|NCT02646735|"~     A Randomized, Open label, Parallel-group, Multi-center study. Eligible patients will be~     randomized in a 1:1 ratio to receive fulvestrant 500 mg or Exemestane 25mg.~   "
57343|NCT02816424|"~     Although the Academy of Pediatrics and the Society for Adolescent Health and Medicine~     recommend that teen health providers screen for sexual risk behaviors and provide education~     and counseling to those at risk, there are currently no specific guidelines or protocols~     available to guide such practices, nor have there been any rigorous evaluations of efficacy.~     Preventing teen pregnancy through brief intervention in primary care holds the promise to~     have a significant public health impact and reduce health disparities by engaging, educating,~     and motivating the majority of teens who visit a primary care setting each year. In the~     current study, we seek to rigorously evaluate the impact of brief intervention vs.~     informational control on unprotected sexual intercourse among teens with past year~     unprotected sex at two primary care clinics serving predominately underserved, minority~     populations in New Mexico. The target population for the current study will be 1350 male and~     female teens, aged 13-19, from the Atrisco Center for Family and Community Health and the~     Albuquerque Job Corps Wellness Center. Extensive formative work involving the study~     population will be conducted prior to the trial to refine the motivational interviewing-based~     brief intervention. Eligible youth will be randomly assigned to brief intervention or an~     informational control condition, in addition to regularly offered medically-based~     contraception consultation and prescription services. Follow-ups at 3- and 9- months will~     compare rates of unprotected sex and acceptance of long-acting reversible contraceptives.~     Brief education and counseling interventions could be feasibly implemented during the greater~     than eight preventive and acute primary care visits that the average US adolescent attends~     during their teen years. Such an approach could conserve valuable resources required by more~     intensive interventions for nonresponsive teens with greater need. Furthermore, social~     determinants of health, such as poverty and race, that may reduce access to more extensive~     psychosocial interventions, are less likely to prevent access to primary care, increasing~     health equity.~   "
57344|NCT02816411|"~     In this study the investigators utilized protein supplementation over an 8-day period~     following eccentric exercise-induced muscle damage in order to test the initial hypotheses :~     i) protein supplementation after exercise-induced muscle injury affects exercise-induced~     aseptic inflammation and muscle performance.~   "
57345|NCT02816398|"~     Feasibility clinical study to evaluate the safety and effectiveness of the catheter system~     for the percutaneous creation of an arteriovenous fistula for patients with end stage renal~     disease requiring dialysis access.~   "
57346|NCT02816385|"~     Myocardial protection is a fundamental element for the safety of patients when performing~     cardiac surgery. For this purpose, cardioplegia were rapidly established in clinical practice~     to protect the myocardium when performing aortic clamp.~      Cardioplegia are procedures to stop the contraction of myocardium. It is usually achieved~     with the use of chemicals ( cardioplegic solutions) or cold temperature (such as chilled~     perfusate). The composition of the cardioplegic solutions and their method of administration~     continuously changed over the years.~      At the present date, cold blood cardioplegias are performed in the investigator's center. The~     investigators regularly use two modes of administration: either by an antegrade path~     (injection in the coronary arteries), or a retrograde one (injection in the venous system).~     At present, there are no elements supporting the superiority or inferiority of one path~     compared to another. The difficulty lies within a clear estimation of the contractility state~     of the ventricular cardiac muscle.~      Technological developments in recent years provided a solution to this problem. The analysis~     of the pressure/volume curves generated by a ventricle allows an accurate quantification of~     the myocardial contractility. This requires the use of conductance catheters to accurately~     measure the ventricular volume and the ventricular pressure. The absolute ventricular~     contractility is then deduced with the help of a software.~      The investigators intend to use this pressure-volume loops, obtained with conductance~     catheters, to compare the contractility of the right heart ventricle after antegrade vs~     retrograde cardioplegia.~   "
57347|NCT02816372|"~     Despite the use of protective ventilation, neuromuscular blocking agent and prone position,~     ARDS mortality remains high (30%-50%) in observational studies, and pneumothorax rate in~     randomized controlled trial remains stable (10%). The driving pressure (the ratio of tidal~     volume over respiratory system compliance) has recently been strongly associated with ARDS~     mortality, suggesting that tidal volume reduction below 6ml/kg may offer mortality benefit.~     While extracorporeal CO2 removal technique are currently under investigation in association~     with tidal volume reduction~   "
57348|NCT02816359|"~     Esophageal pressure measurements are used in moderate/severe Accurate Respiratory Distress~     SyndromeARDS patients in order to set ventilator settings. There might be variations of the~     measured value according to the patient position (0° vs 30°) at the time of measurements.~   "
57349|NCT02816346|"~     Development of an S. sonnei human challenge model using a newly manufactured lyophilized lot~     of S. sonnei strain 53G (Lot 1794) that can be used in the future as a challenge strain for~     all S. sonnei vaccine candidates. An adaptable dosing plan will be used to determine the dose~     of Shigella sonnei 53G that induces the primary outcome in approximately 60% of subjects.~   "
57350|NCT02816333|"~     Prospective, single-arm, multi-center registry study A total of 50 subjects with Type B~     aortic dissection who meet all inclusion and exclusion criteria will be included.~      Patients will be treated with TEVAR using conformable TAG endograft (Gore). Patients will be~     followed clinically for 12 months after the procedure. CT will be performed at 12 months.~   "
57351|NCT02816320|"~     In a retrospective cross-sectional study, investigators aimed to valid the variables employed~     to generate standardized mortality ratio from hospital administrative databases. For this~     purpose, investigators have compared those variables collected in administrative databases~     with the information available in patient medical record.~   "
57352|NCT02816307|"~     Infective endocarditis remains a serious disease that requires fast and specialized support~     in 2012. However, 24% of endocarditis unanswered etiology. The systematic use of new policy~     diagnosis, including (i) a systematic use of specific PCR techniques and (ii) the search for~     markers of inflammatory and tumoral diseases, should increase the number of positive~     etiological diagnosis of culture-negative samples.~      Secondly, because of the seriousness of the disease, the investigators were led to develop a~     new score: score for admission. This score, realized in less than 4 hours from the admission~     of the suspected patient with endocarditis, should allow for immediate probabilistic~     antibiotic treatment after completion of the diagnostic kit. The modified Duke score give its~     results in 4 to 7 days. With the score of admission thus diagnostic processes are accelerated~     and, where appropriate, empirical antibiotic therapy started.~      Primary: Evaluate the effectiveness of the new diagnostic strategy on etiological~     identification of endocarditis.~      Secondary: Validate the admission score compared to the modified Duke score.~   "
57506|NCT02814279|"~     The aim of this study was to compare clinical, esthetic and patient-centered outcomes of~     coronally advanced tunnel (TUN) and coronally advanced flap (CAF) both associated with~     connective tissue graft (CTG) in the treatment of gingival recession.~   "
57353|NCT02816294|"~     Housing Prescriptions as Health Care is a research project studying the effects of an~     innovative intervention that combines services across the health, housing, social and legal~     service sectors in order to improve housing stability and child health outcomes among~     participants. The housing intervention developed for this study specifically addresses issues~     including families who are: paying more than 50 percent of income on rent or utilities,~     moving frequently, experiencing homelessness, but are not eligible for shelter through the~     Department of Housing and Community Development's Emergency Assistance program, or were~     unable to pay rent on time in the past year. This research explores how coordinated and~     comprehensive housing services offered through intensive case management improves housing~     stability and health outcomes for families of young children.~   "
57354|NCT02816281|"~     A retrospective cross-sectional analytic study to evaluation and identification of the~     reasons about Scheduled elective surgical case cancellation in Siriraj Hospital, reason of~     cancellation will be extracted from hospital medical record of each case, reviewed and~     divided into 2 groups, with SiPAC and without SiPAC consultation. Primary outcomes are the~     incidence of cancelled case and causes of the cancellation and secondary outcome that will be~     identified for areas of improvement.~   "
57355|NCT02816268|"~     The investigators prospectively investigate the differences between contact-force guided~     pulmonary vein isolation (PVI) and conventional pulmonary vein isolation in patients with~     paroxysmal atrial fibrillation (PAF) with respect to adenosine guided unmasking of dormant~     conduction, procedural and clinical outcome.~   "
57356|NCT02816255|"~     Subjects will all have a two week baseline period in which they will use a nasal mask using~     an air view CPAP machine (which records all data). After the two week period all will switch~     to a full face mask with half using the same CPAP pressure and half with a new a CPAP~     pressure derived from our formula for the final two weeks.~   "
57357|NCT02816242|"~     effect of concept map in teaching critical thinking was done with randomized study~   "
57358|NCT02816229|"~     Massive haemoptysis is a life-threatening condition which is commonly seen in patients who~     have previously had pulmonary tuberculosis. Various treatment options exist such as bronchial~     artery embolisation (BAE) or surgical resection of the affect lung region. However, BAE is~     not considered curative as there is often recurrence of haemoptysis. Furthermore, not all~     patients will be deemed suitable for surgical resection, leaving them with very few treatment~     options. A possible alternative intervention is the insertion of an endobronchial valve~     (EBV). It is speculated that blood will collect distal to the one way valve and a thrombus~     will be formed. There is currently no data describing the use of EBV for the treatment of~     massive haemoptysis. This RCT aims to explore the use and efficacy of EBV in the management~     of massive haemoptysis.~   "
57359|NCT02816216|"~     This project will fully develop and preliminarily validate CampAir, an empirically-based~     dynamic e-health intervention (based on the evidence-based ASMA) to assist adolescents with~     uncontrolled asthma to learn how to manage their illness and improve their asthma control. In~     addition to developing a highly novel product for adolescents with asthma, the research~     proposed for this project will address unique scientific questions. Despite the high asthma~     prevalence among adolescents, few interventions have specifically targeted adolescents. This~     study is innovative in that it is among the few to focus on adolescents, who are often~     overlooked by the healthcare system. This research will assess factors associated with~     successful implementation of CampAir, thereby providing new information regarding how~     e-health interventions can be effectively developed and implemented for use with adolescents~     with asthma.~   "
57360|NCT02816203|"~     Postpartum hemorrhage (PPH), is the leading cause of maternal mortality and is responsible~     for approximately 25% of maternal mortality deaths.It is defined as blood loss in excess of~     500 ml following vaginal childbirth. Primary (immediate) PPH occurs within the first 24 hours~     after delivery.~      In clinical practice, if after giving birth, the placenta is not expelled naturally, an~     active management should be triggered. After obstetric maneuvers therapeutic, options begin~     with uterotonic treatments before considering invasive treatments such as embolization,~     vessel ligation and hysterectomy. However, the morbidity associated with these techniques and~     the desire to preserve fertility mean that new therapeutic solutions have been conceived,~     which has recently led to the development of an innovative intrauterine hemostasis medical~     device : a hemostatic intrauterine suction cup.~      Assuming that postpartum hemorrhages are mainly due to uterine atony, we propose in this~     biomedical research, the study of a new medical device. Our hypothesis is that the uterine~     walls will append to the walls of the suction cup after the latter is put under vacuum. The~     actuation of the suction cup will lead to the aspiration of all sides of the uterus.~      Considering that postpartum haemorrhage is an emergency situation where vital prognosis of~     the patient is engaged, we selected to collect the consent of the patient using an emergengy~     procedure.~   "
57361|NCT02816190|"~     Beneficial effect of prone position in ARDS on mortality is not linked to increase in PF~     ratio. It is probably due to improvement in ventilation-perfusion ratio (V/Q). Volumetric~     capnography allows assessment of dead space and homogeneity of V/Q. All prone positionned~     patients will be included in the study with usual monitoring (i.e. respiratory system basic~     mechanics, volumetric capnography, blood gas samples). Epidemiologic and monitoring data will~     be collected during all prone position sessions.~   "
57362|NCT02816177|"~     Telemedicine-based care provides remote health and social care to maintain people's autonomy~     and increase their quality of life. The rapidly aging population has come with a significant~     increase in the prevalence of chronic diseases and their effects, and thus the need for~     increased care and welfare.~      This solutions give a new opportunity for diagnosis, treatment, education, and~     rehabilitation, and make it possible to monitor patients with a number of chronic diseases.~     It also reduces socioeconomic disparity with regard to access to care and gives equal chances~     to patients from urban and rural areas.~      This a randomized trial of telemedicine versus usual care alone to reduce hospitalization and~     emergency hospital admissions for Nursing Home Residents .~      After an initial assessment , each participant is monitored by teleconsultation on six~     occasions over 12 months. Patients with usual care have an initial and a 12 months~     assessments.~   "
57769|NCT02810808|"~     The study will evaluate the efficacy and safety of two different dosing regimens of~     ranibizumab (0.5 mg on BCVA by 1+PRN vs 3+PRN) in Chinese patients with wet AMD. This study~     is to provide long-term safety data in the treatment of Chinese patients with wet AMD.~   "
57363|NCT02816164|"~     In patients with early-stage breast cancer, chemotherapy has substantially improved survival~     rates. Improvements in outcomes, however, are compromised by the considerable toxicities~     associated with chemotherapy, the most notable being neutropenia. Neutropenia is the presence~     of abnormally few white blood cells, leading to increase susceptibility to infection and can~     require hospitalization and need for intravenous antibiotics and is sometimes fatal. Febrile~     neutropenia (FN) can also be associated with treatment delays and dose reductions,~     potentially compromising treatment efficacy. Patients can receive medication to reduce the~     risk of FN such as Neupogen (filgrastim) as a daily injection for 5, 7 or 10 days. Since~     there is genuine uncertainty among healthcare professionals as to which administration~     schedule of Neupogen is the best for patients, the investigators are performing a randomized~     study for which patients will receive either 5, 7 or 10 days of Neupogen. Neupogen can cost~     approximately $200/injection, so if a physician prescribes 10 days for 8 cycles of treatment,~     this can cost $16,000 compared to a 5 day treatment which would cost half this. In addition~     to cost savings, many patients are not able to give themselves injections on a daily basis~     and require nursing resources which are utilized at high cost. This study will use an oral~     consent model to compare 5, 7 and 10 days of Neupogen to evaluate rates of febrile~     neutropenia and hospitalization.~   "
57364|NCT02816151|"~     Detrusor hyperactivity is an urodynamic observation defined by involuntary detrusor~     contractions during the vesical filling. Within neurological bladders childs, especially~     related to spinal dysraphisms, this hyperactivity, associated or not with vesical compliance~     disorders, can involve a urinary incontinence obstructing social integration and possibly~     vesical pressure rise in the intra- potentially generating the high urinary tract lesions.~     Anticholinergic drugs possibly associated with a vesical draining constitute the treatment of~     first intention. In approximately 15 to 20% of the cases, intradetrusor iterative injections~     of type A Botulinum Toxin are proposed fault of satisfactory results. Largely used according~     to the European consensus of 2008 without AM, actual studies remain realized on small numbers~     with low level of proof. Posology remains discussed between pharmaceutical laboratories~     (derivative of the effective maximum amount per adult kg of weight) and weaker amounts used~     with clinical results.~   "
57365|NCT02816138|"~     Late-life depression is characterized by both affective (mood) symptoms and cognitive~     deficits. There is currently no intervention that may provide consistent benefits to both~     mood and cognitive performance. Agonist activity at the nicotinic acetylcholine receptors via~     transdermal nicotine patches may provide benefit to both mood and cognition, working through~     nicotine's effects on brain neural networks, specifically the cognitive control network and~     default mode network.~      In this initial pilot project, the investigators will test this hypotheses in 15 nonsmoking~     depressed elders with subjective cognitive impairment. Following baseline neuroimaging and~     cognitive testing, participants will receive 12 weeks of open-label transdermal nicotine.~     Afterwards, participants will repeat neuroimaging and cognitive assessments.~   "
57366|NCT02816125|"~     Healthy premenopausal women were enrolled in a diet intervention study that examined the~     effect of a combination EPA/DHA supplement on risk factors associated with breast cancer. In~     a randomized cross-over design, women consumed their habitual diet with a supplement for~     three menstrual cycles, had three cycles of wash-out and then consumed a low-fat diet with~     the same supplement. Blood, urine and nipple aspirate fluid were collected periodically over~     the 10 month protocol and analyzed for biomarkers associated with supplementation and future~     risk of breast cancer.~   "
57367|NCT02816112|"~     Taxotere-cyclophosphamide (TC) chemotherapy is commonly used as an adjuvant chemotherapy~     regimen in patients with resected early stage breast cancer. TC chemotherapy can cause~     febrile neutropenia (FN) which can be serious and associated with treatment delays and dose~     reductions, thereby compromising treatment efficacy. To reduce the risk of~     chemotherapy-induced FN,TC is administered with either one of two highly effective standard~     treatments; namely primary prophylaxis with either ciprofloxacin or granulocyte~     colony-stimulating factor (G-CSF). However, there are considerable cost differences between~     these strategies; subcutaneous daily G-CSF costs at least $12,000 over 4 cycles of treatment~     while oral ciprofloxacin costs about $100.~      The investigators have therefore been performing a feasibility study to explore whether the~     integrated consent model involving oral consent is feasible in practice; and whether it can~     be used to increase the number of physicians and patients who take part in clinical trials.~     This feasibility study (REaCT-TC NCT02173262) has been an amazing success and the~     investigators are therefore now performing a definitive study comparing G-CSF with~     ciprofloxacin. This study will not be evaluating feasibility endpoints, but rather clinically~     important endpoints of hospitalizations and febrile neutropenia rates.~   "
57368|NCT02816099|"~     In type-1 diabetes patients, bad cholesterol tends to accumulate because apoC1 function is~     slowed down.~      ApoC1 is a protein whose role is to diminish the activity of CETP, another protein that~     regulates cholesterol transfer in the body.~      The aim of this study is to determine whether it is possible to correct apoC1 function by~     improving glycaemic balance.~      240 persons will be recruited in this study and allocated to one of two groups:~        -  160 Type-1 diabetes patients with uncontrolled diabetes:~             -  4 additional blood samples will be taken at the time of the systematic biological~               examination at inclusion and then again 3 months later.~        -  80 control subjects with normal lipids and normal glycaemia balance will be included in~          the study following the results of the biological assays.~             -  4 blood samples will be taken at the time of inclusion.~   "
57369|NCT02816086|"~     Suboptimal use of medications among geriatric patients is well-known problem and leads to~     medication errors, re-hospitalizations and death. By using a randomized controlled trial~     (RCT) design the investigators aim to explore a new inter-professional working structure. The~     working structure is based on the scientifically and clinically acknowledged integrated~     medicines management (IMM) model. The overall aim of the study is to explore the effect of~     the new working structure on the composite endpoint re-hospitalization + visit to an~     emergency department during 12 months after hospital discharge.~   "
57370|NCT02816073|"~     A randomized study to assess the safety and efficacy of single-session pan-retinal~     photocoagulation (PRP) using Pattern Scan Laser (PASCAL) in proliferative diabetic~     retinopathy (PDR) - 1,700 shots vs 2,500 shots~   "
57371|NCT02816060|"~     Background: There is evidence linking conditioned pain modulation (CPM) deficiency with~     musculoskeletal pain syndromes such as fibromyalgia, migraine, tension-type headaches and~     irritable bowel syndrome, as well as with temporomandibular disorders, idiopathic facial pain~     and chronic fatigue syndrome. Evidence shows that in pre-surgical situations of chronic pain~     there is no activation of CPM.~      Objectives: The purpose of this study is to measure the CPM response and determine whether~     neural tensioner exercise in patients with chronic neck pain is effective in the improvement~     of neck pain intensity, neck disability and cervical range of motion.~      Design: Double-blind, randomized placebo clinical trial. Methods: Patients with neck pain~     will be randomly allocated into two groups: the neural tensionner exercise group (NTE) or the~     sham technique (ST) group.~      Individuals will be included in the study if they meet the following inclusion criteria: aged~     18-65 years, neck pain perceived in the posterior region of the cervical spine, from the~     superior nuchal line to the first thoracic spinous process with more than 12 weeks of~     evolution and without radicular symptoms radiated to the head. Neck pain intensity with a~     visual analogue scale (VAS), neck disability index (NDI), CPM, and cervical rang of motion~     will be measured pre and port intervention.~   "
57372|NCT02816047|"~     Background: The wearable cardioverter defibrillator (WCD) is an established treatment option~     for patients at high risk for ventricular tachycardia / ventricular fibrillation (VT/VF),~     either in whom this risk may only be temporarily present, or in patients at high risk for~     sudden cardiac death (SCD) or after VT/VF in whom an implantable cardioverter defibrillator~     (ICD is currently not possible for other reasons (infection, recent MI <40days, recent~     PCI/CABG < 3months etc.).~      Methods: Comprehensive registry including all patients in Austria who received a WCD in~     2010-2016.~   "
57373|NCT02816034|"~     The purpose of this study is to investigate if individuals with a cannabis use disorder have~     an impaired cerebellar function by assessing possible alterations to their implicit~     adaptation during a visuomotor rotation task.~   "
57374|NCT02816021|"~     You are being asked to take part in this study because you have advanced melanoma.~      The goal of this clinical research study is to learn if oral azacitidine (CC-486) and~     pembrolizumab (MK-3475) can help to control melanoma. The safety of this drug combination~     will also be studied.~      This is an investigational study. Azacitidine is FDA approved and commercially available for~     the treatment of myelodysplastic syndrome (MDS) and acute myeloid leukemia. Pembrolizumab is~     FDA approved and commercially available for the treatment of melanoma. It is considered~     investigational to use this drug combination to treat melanoma.~      The study doctor will explain how the study drugs are designed to work.~      Up to 71 participants will be enrolled in this study. All will take part at MD Anderson.~   "
57375|NCT02816008|"~     Cognitive rehabilitation is defined as a systematic functionally oriented intervention of~     therapeutic cognitive activities based on the assessment and understanding of patient's brain~     behavior deficits. This project focuses on restoring cognitive functions in order to~     understand the underlying deficits in the patient's brain by developing integrated cognitive~     rehabilitation scenarios in virtual reality that combine memory, attention and problem~     solving training with context specific motor movements.~   "
57376|NCT02815995|"~     The goal of this clinical research study is to learn if the combination of durvalumab and~     tremelimumab can help to control sarcoma. The safety of this drug combination will also be~     studied.~      This is an investigational study. Durvalumab and tremelimumab are not FDA approved or~     commercially available. They are currently being used for research purposes only. The study~     doctor can explain how the study drugs are designed to work.~      Up to 150 participants will be enrolled in this study. All will take part at MD Anderson.~   "
57377|NCT02815982|"~     This purpose of this pilot study is to investigate the feasibility of and optimal time post~     cancer treatment to offer caregivers a new health behavior change intervention (NOURISH-T),~     as well as assess its preliminary efficacy on specific child health behaviors. The study will~     also explore whether caregivers NOURISH-T exhibit more improvements than caregivers in EUC~     (standard care).~   "
57378|NCT02815969|"~     This is an observational and exploratory study. Participants will be asked for a blood~     collection and a 24- hour collection of urine. The indol profile and levels of catecholamine~     and metabolites in PRP, as well as in 24- hour collection of urine will be measured with~     LC-MS/MS and analyzed.~   "
57379|NCT02815956|"~     Postoperative ileus (POI) causes patient's discomfort and leads to an increase of cost of~     management after colorectal surgery because of an increase of the morbidity rate or of the~     rate of early rehospitalization after discharge.~      Enhanced recovery programs allowed a reduction of its rate but 20 to 30% of patients will~     experiment POI.~      A new approach during preoperative era, using mastication or preoperative physical activity,~     has been proposed to improve postoperative course. This leads to a vagal activation (action~     especially on upper GI).~      Sacral stimulation using percutaneous tibial nerve stimulation (PTNS) has an effect on lower~     GI.~      The aim of this study was to assess the efficacy and the feasibility of PTNS during~     perioperative course, to prevent POI with respect with placebo.~   "
57391|NCT02815800|"~     ETHNODYNE VISIO is a food supplement composed of an innovative plant-based active ingredient~     acting alongside vitamin B2. It is proposed in patients with visual problems. Based on~     clinical and experimental data, the investigators propose a pilot open study in order to test~     the efficacy of Ethnodyne visio in patients with Parkinson 's disease (PD). The hypothesis~     is that Ethnodyne visio may improve motor and non motor signs of PD. 24 patients with PD will~     be evaluated before and after 3 months of add on treatment by Ethnodyne visio.~   "
57392|NCT02815787|"~     The purpose of the study is to investigate the potential interaction between SP2086 and~     Glyburide after the singe and multiple oral doses treatment in healthy adult volunteers~     respectively.~   "
57393|NCT02815774|"~     The purpose of the study is to investigate the SP2086 pharmacokinetic in Renal Insufficiency~     Patients.~   "
57405|NCT02815618|"~     Feasibility trial on the use of a hybrid optical device integrating time-resolved~     near-infrared spectroscopy (TRS) and diffuse correlation spectroscopy (DCS) for measurement~     of cerebral oxygen metabolism and blood flow in neonates.~      The device wil be tested in four settings measuring:~        1. Changes in cerebral oxygenation and haemodynamics after birth~        2. precision and repeatability~        3. The cerebral vaso-reactivity to arterial carbon dioxide~        4. Assessment of the user-friendliness and loss of signal in routine care~   "
57380|NCT02815943|"~     Bariatric surgery procedures have now been firmly demonstrated to lead to significant~     improvement and even, in many cases, complete reversal of abnormal glucose homeostasis in~     type 2 diabetes (T2D). Various surgery procedures are can be performed to induce weight loss.~     The most striking anti-diabetic effects are observed with biliopancreatic diversion with~     duodenal switch (BPD-DS), followed by Roux-in-Y gastric bypass (RYGB) and sleeve gastrectomy~     (SG). The first two procedures induce both a restriction of energy intake and a low~     absorption of dietary fatty acids while the latter exclusively targets energy intake~     restriction. The investigator and others have shown that improvement of T2D occurs within~     days after BPD-DS or RYGB in the vast majority of patients, prior to any significant weight~     loss. This very rapid metabolic recovery is explained by a normalization of β-cell function~     after meal challenges and ameliorated hepatic insulin sensitivity. The investigator and~     others have shown that these acute anti-diabetic effects are mostly recapitulated by matched~     caloric restriction, independent of changes in gastrointestinal hormones, showing the~     importance of gastrointestinal-derived energy fluxes for acute diabetes control. Muscle~     insulin sensitivity, on the other hand, improves more slowly in association with weight loss,~     demonstrating the heterogeneous metabolic response of the various organs to BPD-DS. Some~     preliminary studies also demonstrate a rapid reduction of NEFA levels and production rate~     upon i.v. administration of lipids during euglycemic hyperinsulinemic clamps. This very rapid~     improvement in NEFA tolerance strongly suggests that adipose tissue storage of circulating~     fatty acids also improves very rapidly, prior to any significant weight loss, after BPD-DS.~     It may also suggest an acceleration of oxidative fatty acid metabolism in organs such as the~     liver, the heart and/or skeletal muscles. Studies of the rapid metabolic changes after~     bariatric surgery conducted thus far rapidly improved the understanding of the fundamental~     pathogenic defects of T2D. However, much remains to be understood about the acute changes in~     gastrointestinal-derived metabolic fluxes, organ-specific metabolic responses to bariatric~     surgery and their relationship with the reversal of T2D. Using in vivo methodological~     approaches, the investigator proposes to investigate the early organ-specific changes in~     dietary fatty acid metabolism in response to BPD-DS vs. SG and their relation to improved~     systemic changes in glucose homeostasis, insulin sensitivity and β-cell function in patients~     with T2D.~   "
57381|NCT02815930|"~     High cost users (HCUs) are a small group of patients who use a disproportionate amount of~     health care resources. This study is a retrospective population-based matched cohort analysis~     of newly incident senior High Cost Users (HCUs) defined as Ontarians aged 66 years or older~     in the top 5% of healthcare expenditure users in fiscal year 2013 (FY2013). The study~     objectives are to characterize and contrast Ontario senior HCUs to non-HCUs based on their~     demographics, co-morbidities, medication use, health service utilization, healthcare~     expenditures, medication costs and clinical outcomes, and to determine the relative~     contribution of medications to senior HCUs expenditures~   "
57382|NCT02815917|"~     Preclinical work suggests that D3 dopamine receptors may be important in the study of the~     pathophysiology of affective disorders, psychotic disorders and addiction. D3 receptors may~     also play a role in dystonia, Parkinson's disease and response to treatment of these~     disorders. However, there has been a lack of specific radioligands for imaging D3 receptors.~     This proposed protocol will evaluate the uptake of [18F]FTP as a more specific in vivo~     measure of D3 receptor binding in the brain in healthy volunteers subjects after injection of~     lorazepam vs placebo, and in cocaine-dependent subjects. Test-retest scans will evaluate the~     variability of [18F]FTP uptake measures in both healthy volunteer subjects and~     cocaine-dependent subjects.~   "
57383|NCT02815904|"~     The role of physiotherapy interventions in treatment of high risk infants has not been~     established even after a number of studies. The high risk infants are prone to developmental~     delays and early intervention is most effective for them owing to the plasticity of brain in~     early infancy. Yakson is one among the most effective and safe methods of tactile stimulation~     for preterm neonates. Tactile and kinesthetic stimulation techniques have been proved to be~     effective but there is no standardized protocol. The present study will try to investigate~     the efficacy of Yakson touch in combination with kinesthetic stimulation on the development~     of high risk neonates against conventional handling which will include developmental~     positioning and Kangaroo mother care.~   "
57384|NCT02815891|"~     TARGET-NASH is a longitudinal observational cohort study of patients being managed for NAFL~     or NASH in usual clinical practice. TARGET-NASH will create a research registry of patients~     with NAFL or NASH within academic and community real-world practices in order to assess the~     safety and effectiveness of current and future therapies.~   "
57385|NCT02815878|"~     This project is an adaptation trial, testing the efficacy of an evidence-based community~     wellness program, Enhance Wellness (http://www.projectenhance.org/enhancewellness.aspx), in a~     sample of middle and older-aged adults living with multiple sclerosis, spinal cord injury,~     post-polio syndrome and muscular dystrophy.~   "
57386|NCT02815865|"~     The investigators intend to conduct a randomized clinical trial comparing 3 methods of~     induction of labor in term primiparous women with singleton. First group will be women~     induced with Foley catheter and pitocin, second group Foley catheter and vaginal dinoprostone~     and third group will be induced with vaginal dinoprostone alone. The investigators compare~     time for induction to delivery and way of delivery.~   "
57387|NCT02815852|"~     The purpose of this study is to review retrospectively cases of breast cancer of the centers~     belonging to the BREST UNIT Tuscany North-West Wide Area and compare the imaging~     characteristics (ultrasound, mammography and mammary MRI if available) of breast cancer with~     the corresponding histological reports and assess whether in women <40 years the typical~     imaging presentation pattern of malignancies observed in women> 40 years are confirmed.~   "
57388|NCT02815839|"~     The objective of the study is to assess the safety, tolerance, food effect, pharmacokinetic~     and pharmacodynamic properties of single dose adminstration of SHR4640 in healthy volunteers.~   "
57389|NCT02815826|"~     The purpose of this study was to evaluate the influence of 16 weeks of progressive barefoot~     running training on impact force and muscle activation in habitual shod runners. Habitual~     shod runners were tested barefoot (BF) and shod (SH), before and after 16 weeks of~     progressive barefoot running training. Tests consisted of running on instrumented treadmill~     at 9 km/h, for 10 minutes in each experimental condition. Nine data acquisitions (10 s) of~     vertical ground reaction force (VGRF) and electromyographic (EMG) signal were conducted in~     each experimental condition, for each test.~   "
57390|NCT02815813|"~     This is a four year project evaluating the effectiveness of a group-based lifestyle~     intervention (PeerFIT) supported by mobile health (mHealth) technology and social media~     compared to Basic Education in fitness and nutrition supported by a wearable Activity~     Tracking device (BEAT) in achieving clinically significant improvements in weight loss and~     cardiorespiratory fitness in young adults with serious mental illness (SMI).~   "
57441|NCT02815150|"~     This study aims to assess the impact of preoperative oral carbohydrate drink on gastric~     emptying and PH of gastric fluid in gastric cancer patients directly. Furthermore,~     investigators aim to evaluate the safety and effectiveness of preoperative oral carbohydrate~     in elective gastric cancer surgery, providing direct evidence for clinical practice.~   "
57394|NCT02815761|"~     Chronic obstructive pulmonary disease (COPD) is a common disease worldwide with a high burden~     on healthcare resources. The prevalence of COPD varied from 11.4 to 26.1% according to a~     recent multi-city population study using spirometry. In Hong Kong (HK), the prevalence rates~     of COPD in the elderly population aged ≥60 years were 25.9% and 12.4% based on the~     spirometric definition of forced expiratory volume in 1s (FEV1)/forced vital capacity (FVC)~     ratio <70% and the lower limit of normal of the FEV1/FVC respectively. In 2005, the crude~     mortality rate of COPD was 29.1/100 000, while the crude hospitalization rate was 193/100,000~     in HK. In HK, COPD ranked second as a respiratory cause for hospitalization. In those 75~     years or older, the hospitalization rate for COPD was as high as 2,225/100,000. The economic~     burden of COPD on the society is enormous.~      Previous studies gave information on the overall morbidity, mortality and the prevalence of~     COPD in HK. One study compared the management of COPD patients in HK with other countries and~     found that COPD patients in HK were under-treated. No large scale study has looked into the~     details of COPD patients in HK, like their co-morbidities and how they are being treated and~     how these factors affect the readmission of these patients. Large prospective studies which~     incorporate all the potentially relevant variables are required to refine prediction of the~     important outcomes of AECOPD and thus to inform clinical decision making, for example on~     escalation of care, facilitated discharge and provision of palliative care.~   "
57395|NCT02815748|"~     The purpose of the study is to investigate the Metabolite identification and material balance~     of SP2086 in healthy adult volunteers.~   "
57396|NCT02815735|"~     The aim of this study is to compare the subjective performance of the comfilcon A contact~     lens against lotrafilcon B contact lens after 4 weeks of reusable lens wear.~   "
57397|NCT02815722|"~     The purpose of the study is to investigate the potential interaction between SP2086 and~     Simvastatin after the multiple oral doses treatment in healthy adult volunteers.~   "
57398|NCT02815709|"~     The primary objective is to evaluate the analgesic efficacy of intravenous (IV) oliceridine~     administered as needed (PRN) compared with placebo in patients with moderate to severe acute~     postoperative pain after bunionectomy.~   "
57399|NCT02815696|"~     Degenerative disc disease (DDD) is the primary cause of low back pain. The most important~     factor in the development of DDD is the vertical load force on the disc, increasing the~     hydrostatic pressure and facilitating discs degenerations. One of the most common conditions~     accompanying DDD is segmental instability of the spine. The pathogenesis evolves in three~     phases characterized by a progressive disc dehydration and loss of the disc height.~      This phenomenon can be observed in magnetic resonance imaging (T2 weighted MRI) as a decrease~     of the water signal inside the intervertebral disc. It is considered as an indirect sign of~     the alteration of the composition (including glycosaminoglycans) and the structure of the~     intervertebral disk with, as consequence, a modification of the spine biomechanics. Animal~     studies showed that disc regeneration could be enhanced by a decrease of the hydrostatic~     pressure. This could be observed as a signal increase on T2 weighted MRI.~      Recent quantitative MRI sequences now allow the quantification of glycosaminoglycans (GAG)~     concentration inside the cartilage and in the intervertebral disc.~      The actual surgical trends are in favor of an anterior (intersomatic) vertebrak fusion,~     associated or not with a posterior fusion. These technics sacrifice the intervertebral disc~     and change the spine biomechanics.~      Based on a pilot study, the investigators believe that the conservation and even a~     regeneration of the intervertebral disc is possible and allows the preservation of the spine~     biomechanics.~      The purpose of the study is to analyze the relations between specific MRI signals, the GAGs~     concentration, and the functional outcome before and after the surgical treatment.~   "
57400|NCT02815683|"~     Rationale: New bronchoscopic treatments for emphysema have shown promise in clinical trials,~     improving lung function, exercise capacity and possibly survival and are now being adopted by~     a number of centres in the Netherlands. It is important to ensure that the benefits seen in~     clinical trials are in fact reflected in clinical practice and that the best use of this~     early 'real world' experience is made to optimise the development and use of these novel~     therapies.~      Overall objective: to develop a national database to record bronchoscopic lung volume~     reduction procedures for patients with emphysema. This is desirable for audit purposes but~     will also be an important resource for research both in gathering data and in facilitating~     collaborations.~   "
57401|NCT02815670|"~     The trial objective is to demonstrate the safety of idarucizumab, as assessed by the~     occurence of patients with drug related adverse events (including immune reactions) and~     all-cause mortality in paediatric venous thromboembolism patients treated with dabigatran in~     ongoing clinical trials who require emergency surgery/urgent procedures or patients who have~     life-threatening or uncontrolled bleeding which requires urgent intervention, when rapid~     reversal of the anticoalugant effect of dabigatran is needed.~   "
57402|NCT02815657|"~     The purpose of the study is to investigate the potential interaction between SP2086 and~     Valsartan after multiple oral doses treatment in healthy adult volunteers.~   "
57403|NCT02815644|"~     The trial will be performed as an open-label, randomised, single-dose, two-sequence crossover~     design for the assessment of effect of food on bioavailability of empagliflozin / linagliptin~     fixed dose combination (FDC) tablet.~   "
57404|NCT02815631|"~     The CARDIOFLOW study compares the standard test, a pressure wire test called fractional flow~     reserve (FFR), with a new method that is based on taking a detailed 3D ECG called~     Cardiogoniometry (CGM).~      FFR is an angiographic technique which measures the physiological significance of a coronary~     stenosis and trial data has shown that basing management decisions on this data improves~     prognosis. However FFR studies are expensive and invasive, whereas CGM is painless and simply~     involves placing 4 sticky pads to the patient's chest / back and is similar to an ECG (heart~     tracing). The investigators want to see whether we can use this new method to find out~     whether treatment with coronary angioplasty would be of benefit. If so, then in the future,~     clinicians could use this method (CGM) rather than pressure wire assessment (FFR). This would~     have several advantages; in particular, it can be easily performed in the clinic and avoids~     the need to use an expensive pressure wire.~   "
57460|NCT02814890|"~     The hypothesis of the study is whether dexmedetomidine plus local anesthetic ropivacaine~     could extend the pain relieve time compared with only ropivacaine when thoracic paravertebral~     block is performed at the end of video-assisted pneumonectomy.~   "
57406|NCT02815605|"~     The incidence of severe post-partum hemorrhage has been increasing in developed countries.~     The reason for this is at least partially unknown. Surgical techniques, holistic treatment~     protocols and strategies in blood product administration may have changed patient outcome~     and, for example the incidence of transfusion related side effects. A retrospective analysis~     of the whole cohort of parturients in 2009-2015 in Tampere University Hospital will be made~     to assess the risk factors for severe PPH (ie. estimated blood loss more than 1500ml during~     delivery) and examine the possible change in blood transfusion strategies and its effect on~     bleeding (for example, implementation of massive transfusion protocol, amount of blood~     products used, effect of red blood cell:fresh-frozen plasma ratio, use of pharmacological~     agents for coagulation management, introduction of new angiological and surgical techniques~     etc.) and complications, laboratory parameters and patient outcome.~   "
57407|NCT02815592|"~     The purpose of this this study is to administer BMS-986012 in Combination with Platinum and~     Etoposide as First-line Therapy in Extensive Small Cell Lung Cancer.~   "
57408|NCT02815579|"~     The purpose of this study is to determine whether this multisectoral agricultural and~     microcredit loan intervention improves food security, prevent antiretroviral treatment~     failure, and reduce co-morbidities among people living with HIV/AIDS.~   "
57409|NCT02815566|"~     Design: Open-label randomised multicenter international strategic trial of older women on~     combination antiretroviral therapy (cART) containing tenofovir-emtricitabine (TDF/FTC) with~     HIV RNA suppression for > 6 months to : 1. Immediate switch of TDF/FTC to tenofovir~     alafenamide-emtricitabine (TAF/FTC) while continuing the third antiretroviral agent.; 2.~     Delayed switch; with switch of TDF/FTC to TAF/FTC at 48 weeks while continuing the third~     agent. Follow up of all subjects to 96 weeks.~      Subject Population: The anticipated sample size is 128 HIV infected women aged 45-55 years~     (peri or early post menopause). .~      Primary endpoint: Percentage change from baseline bone mineral density (BMD) at the lumbar~     spine at weeks 48 and 96.~      Secondary Endpoints: BMD change at hip, trabecular bone score, estimated bone strength by~     high resolution peripheral quantitative computerized tomography (HR-pQCT), muscle quality,~     geriatric assessment; biomarkers of bone, immune activation and inflammation; HIV viral~     suppression; safety, lipid and renal function, cardiovascular risk scores at weeks 48 and 96.~      Expected Outcomes: To determine if a switch from TDF/FTC to TAF?FTC improves BMD to a degree~     correlating with a decreased risk of fragility fracture in aging HIV infected women.~     Secondary outcomes will assess bone strength using new imaging modalities, timing of switch,~     and renal health. This data will be used by health policy makers and providers to determine~     the proper use of TAF/FTC in the aging HIV population.~   "
57410|NCT02815553|"~     Currently, surgical removal remains the main clinical treatment for cardiac tumor patients.~     However, malignant tumors are hard to completely resect. Also, as thoracoscopic surgeries~     induce great operation trauma, some patients cannot tolerate or do not will to take the~     operation. Therefore, new methods and techniques are in urgent need.~      Our center have a 12-year experience of intervention treatment for solid tumors and has~     conducted several animal experiments to verify the effectiveness of transthoracic puncture~     ablation and radiofrequency ablation for ventricular muscle.~      The purpose of this study is to conduct new method of direct transthoracic cardiac~     tumor-targeted Radiofrequency Ablation (RFA) and Laser induced Interstitial Thermotherapy~     (LITT), make minimally invasive treatment plans for cardiac tumor patients, and verify the~     safety and validity of intervention treatment in long term.~   "
57411|NCT02815540|"~     The investigators propose to study the effects of cannabidiol (CBD) on cardiac electrical~     function and the autonomic nervous system in children with Dravet syndrome (DS) and~     Lennox-Gastaut syndrome (LGS), when the CBD is administered as an artisanal oil obtained~     through state dispensaries or other sources. The intent is to begin to assess potential risks~     and benefits of this therapy in a vulnerable patient population by characterizing the effects~     of CBD on EKG findings, heart rate variability and the occurrence of seizures.~   "
57412|NCT02815527|"~     This study evaluates the feasibility of a high whey-protein enteral nutrition formula in 20~     ventilated ICU patients. The primary endpoint of study is the feasibility to attain the~     individualized protein target (≥1.2 g/kg ideal body weight/day) 96-hours after ICU admission.~     Secondary endpoints include tolerance and efficacy in terms of the amino acid response in~     blood.~   "
57413|NCT02815514|"~     The TAVI - Register is a Germany-wide scientific elevation in which data about the aortic~     valve treatment and the therapeutic consequences are documented.~   "
57414|NCT02815501|"~     Obstetric complications are common and can be responsible for maternal and foetal morbidity~     and mortality. Thyroid dysfunction has been identified as a possible cause of obstetric~     complications.~      Many studies have been conducted to estimate the prevalence and define the nature of~     obstetric complications observed in patients with thyroid dysfunction. However, women with~     obstetric complications are not systematically screened for thyroid dysfunction and no~     published study has evaluated the prevalence of thyroid dysfunction in women with an~     obstetric complication. As no consensus has been reached concerning systematic screening for~     thyroid dysfunction in pregnant women, the identification of new high-risk populations could~     possibly result in a change of clinical practice.~   "
57415|NCT02815488|"~     CHF6297 is a potent and selective inhibitor of human MAP kinase p38 being developed as an~     anti-inflammatory agent for the treatment of inflammatory airways diseases. The purpose of~     this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of~     single and repeat doses of CHF6297 as dry powder formulation in healthy subjects and in COPD~     patients. This study is the first administration in humans.~      The study will comprise four parts:~      Part 1 will consist of two cohorts of healthy male subjects to assess the safety,~     tolerability and pharmacokinetics of Single Ascending Dose (SAD) of CHF6297.~      Part 2 will consist of four cohorts of healthy male subjects to assess the safety,~     tolerability and pharmacokinetics of Multiple Ascending Dose (MAD) of CHF6297.~      Part 3 will consist of one cohort of COPD patients to assess the safety, tolerability,~     pharmacokinetics and pharmacodynamics of a repeat dose of CHF6297~      Part 4 will consist of one cohort of healthy subjects to assess the anti-inflammatory effect~     of a repeat dose of CHF6297 after LPS challenge.~   "
57416|NCT02815475|"~     This trial will be conducted for the BBC. The aim of the project is to assess if consuming~     the spice turmeric every other day, in the amount consumed in a curry, can reduce cell damage~     and inflammation. The results of the project will be used to inform the TV program Trust Me~     I'm a Doctor.~   "
57417|NCT02815462|"~     In an earlier study using electronic health records (EHR), the investigators have identified~     nine factors to be significantly associated with FA risk. These nine predictors include~     Furosemide intravenous 40 milligrams or more; Admissions in the past one year; Medifund~     status; Frequent emergency department use; Anti-depressants treatment in past one year;~     Charlson comorbidity index; End Stage Renal Failure on dialysis; Subsidized ward stay and~     Geriatric patient. The investigators have combined these nine predictors into the FAM-FACE-SG~     score for FA risk (defined as 3 or more inpatient admissions in the following 12 months). The~     FAM-FACE-SG risk score has the advantage of being deployed in our hospital's enterprise data~     repository known as Electronic Health Intelligence System or eHINTs for short, on a real-time~     or near real-time basis. On a daily basis, data from multiple data sources are extracted,~     transformed and loaded onto the eHINTS system. The system can be programmed to run every~     midnight to provide risk scores the following morning for patients admitted the previous day.~      In this trial, the intervention is to combine the FAM-FACE-SG risk score in addition to a~     decision making algorithm to guide referrals to various transitional care services based on~     needs assessment on nursing and function. The primary objective is to evaluate the impact of~     our intervention in improving healthcare utilization (hospital readmissions, emergency~     department (ED) attendances, length of stay up to 90 days post-discharge).~   "
57418|NCT02815449|"~     The prevalence of iron deficiency anemia is a wide spread problem in Africa and iron~     fortification can be an effective strategy to decrease this.~      In the current study adding different levels of a stabilizer to iron fortified cubes and it's~     effect on iron bioavailability from these cubes will be studied in the context of a Nigerian~     meal in women.~      24 Female subjects with low serum ferritin levels will be included in the study. The study~     will last 64 days and subjects will be asked to consume a breakfast and lunch prepared with a~     bouillon cube with isotope labeled iron during 3 periods of 5 consecutive days. The~     absorption of iron will be evaluated after every period and compared between the cubes.~   "
57419|NCT02815436|"~     Colorectal cancer (CRC) is one of the major global health challenges. CRC is currently the~     third most common cancer in men and the second common in women worldwide, accounting for~     approximately 10% of all cancers.~      Randomized controlled studies have shown that CRC screening using Faecal Occult Blood Testing~     (FOBT) is effective in reducing cancer mortality by 15-33%. Since yearly testing is~     recommended to maintain programmatic effectiveness, longitudinal adherence is a critical~     component of FOBT-based screening programs. The investigators previous study conducted in~     Hong Kong showed that the rate of compliance with CRC screening was declining since the first~     year of enrolment.~      Nevertheless, it remains unknown whether interventions based on reminder systems could~     effectively enhance longitudinal compliance with FOBT, especially among those who have~     already enrolled in a CRC screening programme. Current evidence does not adequately compare~     whether interactive or one-way reminder messages are superior to usual care (i.e. no~     reminders).~   "
57420|NCT02815423|"~     The purpose of the present study is to evaluate the safety and exploratory efficacy of the~     umbilical cord mesenchymal stem cells for patients with fracture and bone nonunion.~   "
57421|NCT02815410|"~     Prospective, open-labeled, multicenter cohort trial for validation of the role of~     levetiracetam as a sensitizer of temozolomide in the treatment of newly diagnosed~     glioblastoma patients.~   "
57422|NCT02815397|"~     Newly diagnosed histologically confirmed c-myc+ de novo DLBCL. Metformin 500 mg daily x 1~     week, then 500 mg twice daily (BID) x 2 weeks, then 850 mg twice daily until 1 month after~     last cycle of chemo-immunotherapy.~      DA-EPOCH-R every 21 days x 4 cycles (CNS prophylaxis single or triple therapy given~     intrathecally each cycle to patients deemed appropriate by treating physician).~      Restage after 4 cycles with CT. Complete remission or partial remission: complete 2 more~     cycles or radiation therapy (XRT) consolidation per physician. Stable or progressive disease~     will go on to salvage therapy off study.~   "
57423|NCT02815384|"~     The research goal is to continue to add to the extensive body of peer-reviewed evidence that~     demonstrates MRI may be safely performed in patients with cIEDs, after they have been~     evaluated and cleared by cardiology. This study will allow the researchers to collect data~     from the facilities ongoing clinical practice regarding the number and types of any adverse~     clinical reactions, and also to document any changes in the implanted cardiac device that may~     have occurred during the MRI scan. The researchers will also be assessing the results of the~     MRI and how the imaging findings impact patient care and the clinical outcome of the patient.~     This data will then be presented to the FDA and the Centers for Medicare and Medicaid~     Services to further influence federal guidelines and payment structures.~   "
57424|NCT02815371|"~     This study evaluated whether laser acupuncture at the time of embryo transfer (following in~     vitro fertilization) improves implantation rates. Patients were randomized to one of 4 groups~     at the time of embryo transfer: 1) laser acupuncture, 2) needle acupuncture, 3) sham laser~     acupuncture, 4) no treatment.~   "
57425|NCT02815358|"~     This study aims to verify the effects of a segmental stabilization exercise program on the~     anticipatory postural adjustment of subjects with chronic lumbar pain. The effects will be~     assessed by means of superficial electromyography focused on the registry of the onset of~     multifidius and deltoid (anterior and posterior) activity during a repetitive shoulder~     ﬂexion/extension.~   "
57426|NCT02815345|"~     During the resuscitation of preterm infants, withdrawal of non-invasive ventilation is~     difficult. In a recent study in children gestational age <30 weeks of amenorrhea (SA),~     definitive withdrawal rate from the first attempt to stop the non-invasive ventilation was~     32% . In the same study, the median number of attempts before achieving a final withdrawal~     was 3 for children born before 28 weeks. The reasons for weaning failure are multiple and~     little studied. It seems that the type of interface used, mask or cannula, having an~     influence on the effectiveness of non-invasive ventilation . The nasal lesions induced by~     non-invasive ventilation are not uncommon, regardless of the interface used . In a recent~     randomized trial, they ranged from 40% to 50% depending on the type of nasal cannula and~     non-invasive ventilation mode. It is in this case external damage. But we assume that the~     breakdown causes internal lesions dependent on the pressure, humidity and flow. These factors~     are likely to generate a nasal obstruction, source intervention nurses who aspire nasal~     passages more or less traumatic.~      The nasal cavities are often abused and, because of their key role in breathing, could be~     involved in the withdrawal of ventilatory failure~   "
57427|NCT02815332|"~     This is a 12-week, multi-center, double-blind, randomized, three-arm, vehicle-controlled~     study.~      Subjects will be randomized (1:1:1) to 1% or 2 % BPX-01 gel, or vehicle. Subjects will apply~     1g of the gel as a thin film to the entire face at least 30 minutes before bedtime each night~     for 12 weeks. Lesion counts, IGA, and Patient-Reported Outcomes (PGI-S and PGI-I) will be~     performed to assess efficacy.~      Blood draws will be collected at baseline (Day 0), and at Weeks 4 and 12 to evaluate the~     level of minocycline in plasma. Safety will be assessed with the vital signs, brief physical~     examination, clinical laboratory tests, cutaneous tolerance score, incidence of~     minocycline-induced skin hyperpigmentation, incidence of visual disturbances and/or headaches~     suggestive of pseudotumor cerebri, and collection of adverse events.~   "
57428|NCT02815319|"~     Docetaxel chemotherapy is commonly used in patients with breast cancer. With the widespread~     use of steroid premedication, the incidence of fluid retention and skin toxicity side effects~     has been minimal. Premedication with dexamethasone (8mg twice daily) is recommended starting~     the day before chemotherapy and continuing for three days. Patients may forget to take all or~     part of their premedication prior to docetaxel administration, and additional doses of~     steroids are frequently give in place of the forgotten oral dose. The processes around~     treating patients who have incorrectly taken their medication are cumbersome leading to~     significant delays in patients receiving their chemotherapy while the chemotherapy nurse~     tries to contact the patients treating physician for guidance on the dose and route of~     dexamethasone they want administered. Most importantly with the current standard of care~     procedure, by the time the chemotherapy nurse, pharmacist and medical oncologist have spoken~     and made a treatment plan, the patient has been waiting for on average of an additional 1-2~     hours before actually starting their chemotherapy.~   "
57429|NCT02815306|"~     Congenital idiopathic clubfoot (CC) is the fifth most common congenital malformation in~     children. The Ponseti method is an effective protocol for treatment of congenital idiopathic~     clubfoot. Plaster is essential for the Ponseti treatment. This paper describes a new brace~     that can be used for the treatment of clubfoot in newborns and infants instead of plaster.~   "
57430|NCT02815293|"~     The objectives of this study are twofold~        -  To evaluate the safety and efficacy of 0.1% AGN-195263 administered twice daily compared~          to its vehicle in patients with evaporative dry eye (EDE)~        -  To evaluate the systemic pharmacokinetics of 0.1% AGN-195263 administered twice daily in~          patients with EDE~   "
57431|NCT02815280|"~     This is a Phase 3 study to evaluate the efficacy, safety and long-term safety of the topical~     administration of FMX-101, 4% minocycline foam for the treatment of moderate-to-severe acne~     vulgaris.~   "
57432|NCT02815267|"~     This is a Phase 3 study to evaluate the efficacy, safety and long-term safety of the topical~     administration of FMX-101, 4% minocycline foam for the treatment of moderate-to-severe acne~     vulgaris.~   "
57433|NCT02815254|"~     The focus of this project are elderly people who have experienced hip fracture and need at~     least two weeks rehabilitation after discharge from hospital. The aim is to increase the~     evidence-based knowledge base for planning and appropriate follow-up intervention for~     patients with hip fracture on short-term / rehabilitation stays. In this study the~     investigators want to explore whether training High Intensity Functional Exercises (HIFE) ,~     of short duration ie a 2- 4 week program and frequent intervention ie 5 times per week has a~     significant positive effect on physical function, pain and quality of life. The main aim is~     to explore whether a high intensive strength and balance training program has better effect~     than a low intensive strength and balance training program on functional status measured by~     Short Physical Performance Battery (SPPB) in patients with hip fractures. Another aims is to~     explore whether this high intensive strength and balance training program has better effect~     than a 'low intensive strength and balance training program' on pain, endurance and quality~     of life measured respectively Numeric Pain Rating Scale (NPR), 6-minute walk test and SF-36.~     The study is a randomized controlled trial.~   "
57434|NCT02815241|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
57435|NCT02815228|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
57436|NCT02815215|"~     Congenital clubfoot(CCF) is a kind of common congenital foot deformities in children. Though~     Ponseti method can cure most of the CCF patients, there are still part of patients can not~     get satisfactory recovery, especially those children classified as Dimeglio grade Ⅲ and Ⅳ.~     Carroll's technique is considered to be an ideal method of surgical treatment. But the~     postoperative scar is relatively large, and accordingly the postoperative complications is~     still common. Based on the clinical practice of the investigator's group, a modification of~     Carroll's technique, minimally invasive Carroll's technique, was applied. For the Dimeglio~     grade Ⅲ and Ⅳ CCF, the postoperative excellent and good rate was over 90%. Therefore, the~     investigator conducted a multicenter randomized controlled trial on treatment of congenital~     idiopathic clubfoot with minimally invasive Carroll's technique.~   "
57437|NCT02815202|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
57438|NCT02815189|"~     Aim to compare Incidence of flare-ups and apical healing after single-visit or two-visits~     treatment of teeth with necrotic pulp and apical periodontitis after a two-year control~     period.~      110 teeth with a diagnosis of pulp necrosis and apical radiolucency at the apex. Working~     length was established with EAL and confirmed radiographically. M4 system with Flex-R files~     were used to complete canal preparation. Level of discomfort were recorded and cases with~     severe postoperative pain and/or swelling were classified as flare-ups.~   "
57439|NCT02815176|"~     Thrombotic biomarkers and angiographic characteristics were compared among the de novo~     patients of central serous chorioretinopathy (CSC), polypoidal choroidal vasculopathy (PCV)~     and the control.~   "
57440|NCT02815163|"~     Degenerative arthritis is a common and serious chronic illness that impacts the quality of~     life of older adults. Knowledge about the effects of empowerment education program in older~     adults with total hip replacement surgery are limited. As far as the investigators know, this~     is the first study done using empowerment education intervention to promote total hip~     replacement patients' self-care. This partnership is achieved through active participation to~     learn as well as sharing their knowledge and experiences with clinicians and patients.~     Furthermore, patients had developed some degree of self-efficacy and improve their depressive~     mood from the disease related knowledge acquired.~   "
57442|NCT02815137|"~     The purpose of this study is to determine if the XPO1 E571K mutation could be used as~     molecular residual disease biomarker in classical Hodgkin's lymphoma. To determine the~     interest of the mutation assessment by digital Polymerase Chain Reaction, sensitivity and~     specificity after 2 courses of chemotherapy (C2) will be compared with the deltaSUVmax~     determined by Positron Emission Tomography after C2 and at end of treatment.~   "
57443|NCT02815124|"~     Cochlear implants are surgically implanted devices which restore the ability to hear to the~     hearing impaired. While remarkably successful, even in the best of performers restoration of~     hearing to levels of normal listeners is unusual. Approximately 3 weeks after surgery,~     cochlear implants are activated via mapping - a process in which each individual electrode~     (FDA approved cochlear implants have between 12 and 22 electrodes) is turned on and the~     stimulus level adjusted to a level that is comfortable and beneficial to the recipient. At~     present, this standard of care mapping procedure is performed without knowledge of the~     physical location between the cochlear implant electrodes and the neural interface. Our team~     has developed a new method of mapping using post-operative CT scans and image processing to~     specify the physical relationship between the cochlear implant electrodes and the neural~     interface allowing customized mapping. Using this information, the investigators deactivate~     sub-optimally positioned electrodes. The investigators term this Image-guided Cochlear~     Implant Programming (IGCIP). In a prospective fashion, the investigators have implemented~     IGCIP on cochlear implant recipients who have had at least 6 months of standard of care (SOC)~     mapping. The purpose of this study is to perform a randomized controlled trial (RCT) on newly~     activated cochlear implant recipients randomizing between IGCIP and SOC.~   "
57444|NCT02815111|"~     The purpose of this research study is to see if pain can be better controlled with fewer side~     effects. The new drug regimen will study several different medicines that have different ways~     of treating pain.~   "
57445|NCT02815085|"~     The primary objective is to examine feasibility of incorporating RecoverLINK into the~     standard of care as a function of (i) user engagement, (ii) user satisfaction, and (iii)~     workflow efficiency. As secondary objectives, the investigators will collect preliminary data~     to examine the association between patient engagement with the RecoverLINK app and (i)~     changes in patient knowledge and behavior, and (ii) hospital readmission(s) at 30, 60, and~     90-day time periods post-enrollment.~   "
57446|NCT02815072|"~     Medical researchers of National Heart Centre Singapore will carry out a state-of-the-art~     study that examines the possibility of changing patients' own cells into multi-functional and~     potent stem cells called iPS cells. These iPS cells can subsequently give rise to functional~     cardiac cells (myocytes) and other cardiovascular cells which might give further clues into~     the manifestation of the structural heart disease. This study involves blood sample~     collection for pre-screening and skin biopsies to establish skin cell culture.~   "
57447|NCT02815059|"~     This is a Phase I, single-center, open label, prospective, single-arm, dose-escalation and~     multi-dose study evaluating the use of ibrutinib in combination with dasatinib and prednisone~     therapy.~   "
57448|NCT02815046|"~     This study compares mixed urinary incontinence symptoms before and after a combined treatment~     with Botox and Bulkamid. Eligible for the study are adult females with a mixed urinary~     incontinence, having both urgency urinary symptoms and stress urinary symptoms.~   "
57449|NCT02815033|"~     The aim of the study is to assess the clinical utility of 11C or 18F-Choline Positron~     Emission Tomography (PET)/Computed Tomography (CT) scan, Whole Body Magnetic Resonance~     Imaging (MRI) versus conventional bone scan and prostate-specific antigen (PSA) measurements~     in response prediction to treatment with Enzalutamide in Hormono-Sensitive Metastatic~     Prostate Cancer patients.~      The study will assess how these 2 imaging modalities perform compared to traditional serial~     PSA measurements and bone scan in assessing metastatic tumour load, progressive disease and~     response to treatment with Enzalutamide.~      In addition measurements of serially collected circulating tumour cell (CTC) samples,~     cell-free tumour DNA and RNA will be performed in order to evaluate their predictive value in~     terms of response measurement.~   "
57450|NCT02815020|"~     The purpose of this project is to use the Agency for Healthcare Research and Quality patient~     self-management support tools and resources across four practice-based research networks and~     16 member practices using a community-based participatory intervention called Boot Camp~     Translation.~   "
57451|NCT02815007|"~     The purpose of this study is to evaluate the efficacy and safety of Chidamide with EGFR-TKI~     for Advanced EGFR-TKI-resistant Non-Small Cell Lung Cancer~   "
57452|NCT02814994|"~     The Acute Respiratory Distress Syndrome (ARDS) is one of common clinical critically diseases.~     In the United States, the incidence of ARDS reaches 31%, which is one of the main causes of~     death in patients. There is no unified treatment process for ARDS currently and the treatment~     measures are not yet standardized, so the standardization of ARDS treatment processes is~     needed to reduce mortality in patients. Following the evidence-based medicine principles and~     six-step treatment standards of ARDS, this study uses the method of multi-center randomized~     controlled clinical trials to evaluate the standardized treatment process of ARDS, which~     provides the basis for the standardized treatment of ARDS.~   "
57461|NCT02814877|"~     The main objective of the project is to evaluate the efficiency and cost-effectiveness of~     different strategies aiming at optimizing antibiotic prescribing in hospitals. In the first~     section of the project, the project team intend to map the different antimicrobial~     stewardship programs in French hospital, by investigating a sample of 30 healthcare~     facilities, and determine the strategies to be evaluated by the model. The investigators will~     also evaluate physicians' adherence to the intervention to promote better use of antibiotics~     and explore potential barriers and facilitators to the implementation of effective~     strategies.~   "
57538|NCT02813863|"~     This is an open single and self-control study,planning to recruit 24 cases of healthy male~     volunteers.In the study,subjects were given SP2086 and metformin,and collects blood samples~     before and after medcine.The purpose is to evaluate the drug interaction between SP2086 and~     Metformin.~   "
57539|NCT02813850|"~     The purpose of this study is to assess the efficiency of the preventive oxygen therapy on the~     occurrence of vaso-occlusive complications, which last more than 24 hours and require~     hospitalisation, in women with sickle cell disease.~   "
57453|NCT02814981|"~     On 04/30/2015, ANSM (the National Security Agency of Medicines and Health Products) shared an~     information for general practicioners, pediatricians, anesthesiologists, dermatologists,~     geriatricians, psychiatrists, community pharmacists and hospital about using hydroxyzine and~     the associated risk of QT prolongation on the electrocardiogram.~      Drugs containing hydroxyzine (the best known and most used is the Atarax®) are used in France~     in various indications including the treatment of minor manifestations of anxiety,~     premedication with general anesthesia and the symptomatic treatment of urticaria.~      A prolonged QT interval is a known risk factor for occurrence of torsades de pointes which~     can cause sudden death. We distinguish congenital and acquired long QT interval. The main~     cause of acquired long QT interval is a drug inhibition of the HERG potassium channel 1. Many~     drugs have been reported to cause sudden death by prolongation of QT interval and occurrence~     of torsades de pointes (macrolides, anti -arythmics, some psychotropic ...) The molecules~     based on hydroxyzine are known to be at risk of prolongation of QT interval in an~     experimental point of view but is not clearly identified in daily clinical practice.~     Pharmacology unit of Caen was the first to publish a case of QT prolongation under~     hydroxyzine . Through this publication, associated with other clinical data, hydroxyzine has~     been added to the list of drugs that can induce QT prolongation .~      Despite these recent recommendations, it does not seem that hydroxyzine prescriptions were~     changed daily and therefore the risk of QT prolongation persists. We therefore propose the~     study of the impact of hydroxyzine on the QT interval measured on the electrocardiogram in~     patients hospitalized at the University Hospital of Caen.~   "
57454|NCT02814968|"~     The aim of the study is to assess the clinical utility of 18F-fluoro-deoxyglucose Positron~     Emission Tomography (PET)/Computed Tomography (CT) and Whole Body Magnetic Resonance Imaging~     (MRI) versus conventional bone scan and prostate-specific antigen (PSA) measurements in~     response prediction to treatment with Enzalutamide in castration-resistant prostate cancer~     patients.~      The study will assess how these 2 imaging modalities perform compared to traditional serial~     PSA measurements and bone scan in assessing metastatic tumour load, progressive disease and~     response to treatment with Enzalutamide in castration-resistant prostate cancer patients.~      In addition measurements of serially collected circulating tumour cell (CTC) samples,~     cell-free tumour DNA and RNA will be performed in order to evaluate their predictive value in~     terms of response measurement.~   "
57455|NCT02814955|"~     Atrial fibrillation (AF) is the most common cardiac arrhythmias with a constantly growing~     prevalence AF. The purpose of paroxysmal AF processing is to control outbreaks from these~     pulmonary veins, medicated way (antiarrhythmic) or interventional. Ablation (radiofrequency~     or cryotherapy) has become in this context recognized and effective treatment of AF. In~     addition, antithrombotic treatments in this context is a major treatments for the prevention~     of stroke (stroke). They are most often associated with antiarrhythmic treatment to prevent~     recurrence of AF or to slow it during a relapse.~      Recent experimental studies have highlighted the direct electrophysiological properties of~     dabigatran and rivaroxaban in the pulmonary veins and the left atrium. Dabigatran~     demonstrated in this study that it induced a prolongation of potential action in the~     pulmonary veins and the left atrium and it decreased the incidence of FA-induced by~     stimulation. Conversely, rivaroxaban induces shortening of the action potential in the left~     atrium (untested properties in the pulmonary veins). To our knowledge, apixaban and warfarin~     have not been studied in this context.~      It is therefore possible that some of the new oral anticoagulants (NACOS) or some AVK~     (fluindione and warfarin), have direct electrophysiological effects in the pulmonary veins~     and on the left atrium and could influence AF recurrences (with effect  antiarrhythmic-like~     or rather a pro-arrhythmic effect) after ablation.A retrospective analysis conducted at the~     University Hospital of Caen on very low numbers suggest that patients on dabigatran would~     have less pulmonary veins connected in early ablation procedure that patients on warfarin or~     rivaroxaban. Despite the limitations inherent in this analysis (very low numbers,~     retrospective analysis, unique setting and having studied his own limits), these results are~     consistent with the fundamental studies, and thus encourage us to pursue our hypothesis to~     obtain more statistical power and reliability in our measurements and results.~      We therefore propose the study of the electrophysiological effects of NACOS (apixaban,~     dabigatran, rivaroxaban) and warfarin (warfarin and fluindione) on the pulmonary veins and~     the left atrium of patients referred for ablation of paroxysmal AF (radiofrequency or~     cryotherapy ) the CHU of Caen and Tours and clinic Saint Martin Caen.~   "
57456|NCT02814942|"~     Aim:To determine the baseline characteristics of heart failure patients in Singapore~     undergoing cardiac resynchronization therapy (CRT); the long term outcome and predictors of~     response to CRT.~      Methodology:Among patients undergoing CRT for severe heart failure according to indications~     stipulated in international Cardiology guidelines, baseline demographic data is collected.~     Age, gender, NYHA functional class, co-morbidities, QRS width on ECG, presence of left bundle~     branch block pattern on ECG, presence of atrial fibrillation, left ventricular ejection~     fraction (LVEF) on echocardiogram, ventricular dimensions, 6 min walk test distance are~     collected. In addition, during the CRT implant procedure, blood is drawn from the vascular~     access and analysed for NT-pro BNP levels and other biomarkers of heart failure.~      The echocardiographic and ECG parameters and blood biomarkers are reanalysed at 6 months and~     12 months following CRT implant. Response to CRT is defined as a reduction in the iLVESV~     (left ventricular end-systolic volume index to body surface area) of >/= 15% and/or an~     increase in the LVEF of >/= 10%.~   "
57457|NCT02814929|"~     The study includes preterm infants who are being screened for ROP between April 1,2016 and~     April 30, 2017 in 69 neonatal intensive care units (NICUs) in Turkey. Infants with birth~     weight (BW) of ≤1500 g or ≤32 weeks' gestation and those with a BW of greater than 1500 g or~     gestational age (GA) >32 weeks with an unstable clinical course are included. The incidence~     of any ROP, severe ROP and treatment modalities will be determined. The risk factors for ROP~     development will also be evaluated.~   "
57458|NCT02814916|"~     To determine the safety and descriptive efficacy of dalbavancin for the treatment of acute~     bacterial skin and skin structure infections in children, aged 3 months to 17 years, known or~     suspected to be caused by susceptible Gram-positive organisms, including~     methicillin-resistant strains of Staphylococcus aureus.~   "
57459|NCT02814903|"~     Post-operative atrial fibrillation (POAF) is a major and frequent complication occurring~     after cardiac surgery, contributing to prolonged intensive care and hospital stays and is~     associated with several cardiovascular complications. The exact mechanisms and signaling~     pathways involved in the development of POAF seem to be multifactorial and remain to date~     incompletely understood. β-blockers and amiodarone are the first line preventive drugs but~     are partially effective and near 30% of POAF resist to these strategies. In this context,~     there is some evidence indicating that renin-angiotensin-aldosterone system and Galectin-3~     (Gal-3) share signaling pathways in the development of cardiac fibrosis and therefore could~     be very useful predictive biomarkers of POAF and potentially interesting therapeutic target~     to prevent POAF occurrence.~      The investigators hypothesis is that preoperative plasma aldosterone levels and galectin-3~     (Gal-3) expression (in plasma, right atrial appendage or epicardial fat) could be predictive~     of POAF in patients undergoing elective CABG surgery with preserved LVEF.~   "
57462|NCT02814864|"~     Patients receiving radiation therapy are still at risk for side effects due to off-target~     radiation damage of normal tissues The number of cancer patients is expected to increase from~     14.1 million around the world in 2012 to 19.3 million in 2025. Up to ten percent will develop~     late severe gastrointestinal complications (i.e. Pelvic Radiation Disease - PRD). Symptoms~     are proctopathy (5-20%) and radiation-induced cystitis (3,5%) that affect quality of life.~     The treatment of PRD is limited to managing the symptoms; new alternatives should be~     proposed.~      Clinical trials using MSCs to treat hemorrhagic cystitis, proctopathy have demonstrated the~     feasibility to used MSCs in these pathologies :~        -  MSCs successfully repair hemorrhagic cystitis, and perforated colon in patients with~          hemorrhagic cystitis, perforated colon and peritonitis.~        -  Six clinical trials are currently ongoing for proctopathy, 3 are phase III. Results~          suggest an inhibition of chronic inflammation and fistulization and interruption of~          hemorrhagic syndromes.~        -  Clinical trials to evaluate the efficacy of MSCs to treat hemorrhagic cystitis is in~          progress.~        -  A decrease in pain after the injection of MSCs was observed in patients treated by~          radiotherapy for breast cancer, radiation burns, and radiotherapy over-dosage.~        -  Four patients, were treated with MSCs after receiving overdose pelvic irradiation for~          prostate cancer. A decrease in pain (EN score), bleeding and diarrhea was observed.~      MSCs will represent a promising alternative strategy in the treatment of severe enteritis,~     rectitis and cystitis after radiotherapy, and may avoid surgical treatment and may diminish~     the adverse effect of PRD in terms of chronicity, morbidity, mortality and health costs.~   "
57463|NCT02814851|"~     The left atrium appendage (LAA) is a remnant of the original embryonic left atrium formed~     during the third week of gestation. LAA is believed to function as a decompression chamber~     during left ventricular systole and other periods when left atrial pressure is elevated. The~     LAA is also a major endocrine organ and is the main producer of ANP (atrial natriuretic~     peptide) in the human heart. The ANP concentration is 40 times higher in the LAA walls than~     in the rest of the atrial wall. A study of patients having undergone the maze procedure and~     associated LAA removal found a significantly lower ANP secretion and an increase in salt and~     water retention. Whether this could eventually lead to hypertension or heart failure symptoms~     is not known.~      Removal of the LAA is routinely performed during antiarrhythmic surgical techniques (MAZE~     surgery) to reduce the risk of subsequent LAA thrombus. Furthermore, new percutaneous~     ablation techniques target LAA to reduce further risks of atrial fibrilation recurrences.~     However, in addition to effects on diastolic atrial function and atrial natriuretic peptide~     (ANP) secretion, this could potentially reduce stroke volume and cardiac output and may thus~     promote heart failure. Its removal could be particularly detrimental in patients with~     existing heart failure and high intraatrial pressure, as it would further promote pulmonary~     congestion and also reduce their cardiac output.~      The study will be conducted at the CHU Brugmann Hospital, with collaboration between cardiac~     surgery and cardiology wards. Subjects referred for non valvular cardiac surgery will be~     prospectively included during the first 6 months following the onset of the protocol.~     Echocardiographic and invasive data will be collected simultaneously.~      The goals of the study are:~        -  To evaluate the immediate impact of temporary closure of the LAA using a vascular clamp~          in the beating heart of human subjects during cardiac surgery. Impact of LAA occlusion~          will be measured using transesophageal echocardiography and hemodynamic measurement of~          the cardiac output.~        -  To correlate echocardiographic parameters with in situ hemodynamic data.~      A significant role of the LAA in the cardiac hemodynamic including the left ventricle outflow~     might have different clinical implications and will raise questions about:~        -  Appropriateness of LAA resection in antiarrhythmic surgery~        -  Importance of restoring sinus rhythm in atrial fibrilation patients~        -  Importance to spare LAA from ablation during atrial fibrilation ablation to avoid~          significant consequences on cardiac function.~        -  Appropriateness of the LAA occluding device in atrial fibrillation patients.~   "
57464|NCT02814838|"~     The objective of this clinical trial is to investigate whether ladarixin has sufficient~     activity (preservation of β-cell function and slow-down of the progression of T1D) to warrant~     its further development (proof of concept trial). The safety of ladarixin in the specific~     clinical setting will be also evaluated.~      The study will be a phase 2, multicentre, double-blind study. It will involve 72 patients~     with new-onset type 1 diabetes (T1D), randomly (2:1) assigned to receive either ladarixin~     treatment (400 mg b.i.d. for 3 cycles of 14 days on/14 days off - treatment group) or placebo~     (control group). Recruitment will be competitive among the study sites, until the planned~     number of patients is enrolled.~   "
57465|NCT02814825|"~     The purpose of this post-market study is to collect data on ViviGen and how its use affects~     fusion rates in the cervical spine when used as additional grafting material to fill the~     cervical spacer. The patient population of interest is patients who have already elected to~     undergo a 2-3 level ACDF surgical procedure using ViviGen, per standard of care.~   "
57466|NCT02814812|"~     Pancreatectomy represents the classic approach for resectable lesions of the pancreas,~     duodenum and periampullary region. Due to the technical skills required, the complex anatomy~     and the extreme fragility of the pancreatic parenchyma, pancreatic resection is still~     considered to be at risk of postoperative complication mainly due to pancreatic juice leaks.~     Anastomotic leaks are the major cause of morbidity and in-hospital mortality due to the~     activation of pancreatic enzymes and the following infectious and hemorrhagic complications.~     Severe complications negatively affect postoperative outcomes, long-term survival, quality of~     life, and costs. Operative mortality traditionally has been defined as the rate within 30~     days or during the initial hospitalization. But in pancreatic surgery mortality rates within~     90 days after pancreatic resection are double those at 30 days. In the present study, the~     investigators sought to evaluate the usefulness of postoperative CT-scan on the seventh~     postoperative day before discharging the patients to detect undiagnosed postoperative~     complication.~   "
57467|NCT02814799|"~     The research for a haemostasis and for an effective osseous healing are a major stake in oral~     surgery. The use of glues of fibrin, amplifying the polymerization of the fibrin during the~     haemostasis is known to reduce the risk of post-operative bruise and accelerate the healing~     but these glues present the inconvenience to be by-products of the blood, not devoid of~     infectious risk.~   "
57468|NCT02814786|"~     This research will lead to the first evaluation of intrinsic and dynamic joint and muscle~     mechanics of equinus in cerebral palsy. It would provide a direct cause and effect~     relationship between equinus and bone deformity. Mechanical insights to the pathophysiology~     of the targeted muscles will lead to better understanding and, thus, to a better medical and~     surgical management of equinus deformity. Secondary aim will provide an important insight~     whether key gait parameters can be exclusively relied upon for surgical treatment planning~     and evaluation. In a medium-term perspective, depending upon the results of this study,~     dynamic MRI of the ankle joint may serve as a guiding tool for fixed equinus surgery in case~     of cerebral palsy.~   "
57484|NCT02814578|"~     The primary objective is to determine whether IVUS- (vs. OCT-) guided BVS implantation is~     non-inferior to achieve a large in-scaffold minimal lumen area (primary endpoint) measured by~     OCT at 1-year follow-up.~   "
57469|NCT02814773|"~     With nearly one million cases of dementia in France in 2010, Alzheimer's disease (AD) and~     related syndromes are a major public health issue. The lake of drug for treatment or~     preventing AD, health related quality of life (HRQoL) became an essential criterion of~     evaluation to assess the treatment strategies of patients. Generic HRQoL tools are generally~     less sensitive for a given disease. That is why other specific tools for AD have been~     developed. None of them was validated in French. The aim of this study was therefore, after a~     review of the literature, to achieve a cross-cultural adaptation and psychometric validation~     of the Quality of Life in Alzheimer's Disease (QoL-AD) and Dementia Quality of Life~     (DQoL). These two questionnaires were selected because they were the most popular in English-~     language literature for this disease.This study concerned a total of 155 patient-caregiver~     pairs recruited from six French hospitals and a Francophone Swiss center. Patients had a~     confirmed diagnosis of AD (mild stage to moderate: Mini Mental State Examination ≥ 10).~     QoL-AD and DQoL were administered by an interviewer. The caregiver sheet of QoL-AD was~     self-administered. Cross-cultural adaptation and psychometric validation have been carried~     out for these two questionnaires.~   "
57470|NCT02814760|"~     Acute stroke management represents a true medical emergency that requires prompt diagnosis~     and urgent treatment. In a previous exhaustive cohort study conducted in the Rhône region,~     France (AVC69) (Porthault et al. 2013) the investigators observed that only a small~     percentage of patients could access to thrombolysis in time. In this cohort of 1306 patients~     treated in one of the emergency department of the Rhone region for a suspected stroke, 84% of~     patients reached hospital through an emergency department instead of going directly to a~     stroke unit. Among those patients, only 2% were finally thrombolysed. A significant part of~     patients arrived in the emergency department too late to be thrombolysed. However, among the~     subset of ischemic stroke patients who reach emergency department less than 3 hours after~     symptoms onset, and who had no clinical or radiological exclusion criteria for thrombolysis,~     only 15 % were thrombolysed. The hypothesis was that an intervention designed to improve ED~     professional's knowledge and skills and to develop together efficient clinical pathway would~     decrease door-to imaging time and consequently door-to needle time and eventually improve~     overall thrombolysis rate.~      The investigators have conducted a cluster randomized controlled stepped wedge trial. All~     adult patients with suspected stroke arriving in one of the participating ED were included in~     the study along five successive four-month periods. The program featured: development of~     written materials (booklets) and video (film), and one day session of standardized training~     for trainers, at least one nurse and one physician of all EDs, with formal presentation to~     improve knowledge, and simulation to improve skills for using the FAST tool (nurses) and~     the NIHSS score (ED physicians). Additionally, a clinical pathway was developed to adapt~     general evidence based guidelines to the local organization. The primary outcome is the~     door-to imaging time.~   "
57471|NCT02814747|"~     After the use of DNA chips for diagnostic purposes, high-throughput sequencing (HTS) is~     transforming the field of developmental diseases, from fundamental research to care.~     Nonetheless, before HTS can be transferred to everyday clinical practice, in particular for~     expert diagnosis using exome HTS, it is necessary to anticipate the nature of the information~     to be given to patients and to parents in order to obtain consent for exome HTS.~      The objective in terms of public health is to allow patients with rare diseases to benefit~     from innovative technologies in optimal conditions of information and accompaniment.~      the objectives of this project are to~        1. evaluate the preferences of families of patients with development disorders as regard to~          suspicious and incidental findings from HTS before its introduction for diagnostic~          purpose,~        2. and then, following the exome analyses carried out for diagnostic purposes, describe,~          analyse and understand the experience, expectations and reactions of families and~          geneticists concerning the diagnostic trajectory in general and at the time the results~          of the HTS were announced in particular A methodology that associated quantitative and~          qualitative approaches was chosen so as to combine the advantages and overcome the~          shortcomings of each: a quantitative study to investigate a large number of patients,~          which would ensure a certain representativeness of the population and allow sub-groups~          analyses to study the upstream phase concerning indications for high-throughput~          sequencing; and a qualitative study, which though it allows only a small number of~          patients to be investigated, makes it possible to describe, analyze and understand in~          depth the complex downstream phenomena of high-throughput sequencing results~   "
57472|NCT02814734|"~     Abdominal Compartment Syndrome (ACS) is a well known condition occuring in critically ill~     patients in intensive care units.~      This syndrome features a sustained intra abdominal hypertension (IAH) above 20 mmHg and a~     multiple organ failure due to the raise of the intra abdominal pressure.~      Several reviews described CT findings linked to these conditions, but most of them suffer an~     insufficient statistical method.~      Furthermore, the main CT feature described as specific in ACS, Round Belly Sign (RBS), has~     been highly debated since.~      This study is aimed to evaluate, in a prospective way, the diagnostic and prognostic value of~     CT findings in abdominal hypertension and abdominal compartment syndrome patients hosted in~     intensive care units, based on previous reviews and adding three new CT features described~     for the first time.~   "
57473|NCT02814721|"~     Infiltrations from cannulation difficulties result in significant morbidity including loss of~     vascular access (VA) loss in hemodialysis (HD). Cannulation is reliant on personnel skill and~     VA characteristics. Surface marking of VA lacks real-time information and traditional~     ultrasound (US) devices are large, expensive and require skilled operator expertise. Sonic~     Window© (Analogic Ultrasound, Peabody, MA) is a coronal mode ultrasound device (CMUD)~     approved for VA cannulation. Study is a single center randomized, prospective pilot study~     comparing handheld US-guided cannulation of new arteriovenous fistula (AVF) to standard~     cannulation practices.~   "
57485|NCT02814565|"~     The purpose of this study is to assess the effect of cyclobenzaprine hydrochloride (HCl)~     extended release (CER) 15 mg once daily in subjects with muscle spasms associated with acute~     painful musculoskeletal conditions.~   "
57507|NCT02814266|"~     OBJECTIVE: This study aimed to determine the sensitivity and specificity of various anatomic~     measurements alone or in combination in predicting difficult intubation. The investigators~     hypothesized that goniomastoid distance, thyrogonial distance and tongue movements are~     sensitive and specific tests for predicting difficult intubation MATERIALS AND METHODS: The~     investigators included the data of 170 patients (85 difficult intubation and 85 easy~     intubation) who underwent an abdominal surgery under general anesthesia. Patients in~     difficult intubation (n=85) and easy intubation (n=85) groups were matched by age, BMI, and~     gender. Intubation difficulty scale (IDS) scores were recorded. Upward and downward maximal~     protrusions of tongue (UMPT and DMPT, respectively) were evaluated in all patients.~     Anthropometric measurements were measured.~   "
57474|NCT02814708|"~     Toxic Shock Syndrome (TSS) is a severe condition with high morbidity and mortality from the~     hosts overwhelming inflammatory response and cytokine storm. Staphylococcal superantigen~     toxins are the main causative agents. Toxic shock syndrome toxin (TSST-1) being responsible~     for almost all of menstruation associated and more than 50% of all other cases. There is no~     specific therapy.~      The aim of this study is to extend the safety and tolerability of two doses of the BioMed~     recombinant toxic shock syndrome toxin (rTSST-1) Variant Vaccine after one to three~     vaccinations in healthy adults. The second aim of the study is to measure immunogenicity and~     persistence of antibodies which produced in response to treatment with the BioMed rTSST-1~     Variant Vaccine over a period of 12 months. These antibodies are expected to be important in~     prevention and mitigation of the diseases. 140 healthy adults, male and female, age 18-64~     years will be assigned to 7 groups comprising two doses of the vaccine or adjuvant at the~     Department of Clinical Pharmacology of the Medical University of Vienna. The patients will be~     monitored for vital signs, hematology, clinical chemistry, and antibodies against TSST-1.~     Immunization will be repeated 3 months after the first with the same dose and 6 months after~     the second immunization in the respective groups.~      Antibodies will be determined through monitoring TSST-1 binding antibodies as assessed~     through ELISA and neutralizing antibodies (exploratory endpoint) as assessed by inhibition of~     T cell activation (3H Thymidine incorporation; ≥ 50%).~   "
57475|NCT02814695|"~     The purpose of this study is to evaluate the efficacy of Baker's yeast extractions ,~     probiotic antioxidant, in scavenging the oxidative stress status mediated damage on sperm~     motility,progressive motility and vitality as well as comparing this potency to that of~     Vitamin E in infertile men.~   "
57476|NCT02814682|"~     The purpose of this study is to elaborate a multi-dimensional indicator of the quality in~     palliative care for patients of end-of-life.~      The study will, as secondary objectives:~        -  elaborate in a standard manner one set of indicators of organization and inner working~          of a palliative care setting.~        -  compare according to these indicators, the qualities of 3 types of palliative care:~          palliative care unit in hospitals, specified identified bed for palliative care patients~          and non-specified bed.~        -  explore the relationship between organizational aspects and results in term of burden.~   "
57477|NCT02814669|"~     This study is designed to assess the safety and tolerability of atezolizumab when given in~     combination with radium-223 dichloride in participants with metastatic CRPC who have~     progressed after treatment with an androgen pathway inhibitor. This adaptive design study~     includes a cohort phase and a potential randomization phase. An initial concurrent dosing~     evaluation will evaluate the safety and tolerability of a treatment regimen that employs a~     concurrent start time for atezolizumab and radium-223 dichloride (Cohort 1). If concurrent~     dosing is found to be safe and tolerable in Cohort 1, additional participants will be~     enrolled and eligible participants will be randomized in a 1:1:1 ratio to Arms A, B, and C.~     If concurrent dosing is not tolerated in Cohort 1, new participants will be enrolled in a~     staggered dosing evaluation: Cohort 2 (28-day radium-223 dichloride run-in, atezolizumab will~     begin on Day 1 of Cycle 2) and Cohort 3 (56-day radium-223 dichloride run-in, atezolizumab~     will begin on Day 1 of Cycle 3). If the Cohort 2 schedule is tolerable, then additional~     participants will be enrolled using this treatment schedule; If the Cohort 2 schedule is not~     tolerable, subsequent participants will be enrolled in Cohort 3. If the Cohort 3 schedule is~     tolerable, then additional participants will be enrolled using this treatment schedule. If~     Cohort 3 schedule is not tolerable, no additional participant will be enrolled in the study.~   "
57478|NCT02814656|"~     AZD8871 is a new chemical entity possessing long-acting effect in a single molecule which~     presents a novel treatment approach to chronic obstructive pulmonary disease [COPD] and~     potentially also asthma (in combination with an inhaled corticosteroid [ICS]). The~     therapeutic goal for AZD8871 is a treatment with greater efficacy than single mechanism~     bronchodilators, with an equivalent or superior safety and tolerability profile. The primary~     purpose of this study is to check the safety and tolerability of AZD8871 at steady state. A~     multiple ascending dose (MAD) design has been selected for this study following the first~     time in man (FTIM), single ascending dose (SAD) study. Three dose levels will be tested in an~     ascending manner. The first dose to be administered will be 300 μg and the 2 subsequent doses~     will be decided based on safety, tolerability and pharmacokinetic (PK) data generated in the~     previous dose. The aim of this study is to also enable further investigations in healthy~     subjects to evaluate and develop AZD8871 as a dual action bronchodilator with an acceptable~     side-effect profile compared to other inhaled bronchodilators on the market as a treatment~     for COPD and asthma.~   "
57479|NCT02814643|"~     This is a randomized, double-blind, parallel group, placebo-controlled study designed to~     investigate the potential effect of a fixed dose of benralizumab administered subcutaneously~     (SC) on antibody responses following seasonal influenza virus vaccination~   "
57480|NCT02814630|"~     This is a single center, non-comparative exploratory study, to investigate the effect of~     omalizumab over a 3-month treatment period in adult (≥18 years) patients with chronic~     idiopathic urticaria who had remained symptomatic despite the use of high dose~     H1-antihistamines.~   "
57481|NCT02814617|"~     The investigators performed randomized, double-blind, placebo-controlled human trial to~     evaluate the efficacy and safety of Cordyceps sinensis mycelium culture extract (Paecilomyces~     hepiali, CBG-CS-2) on promotion of immunity. The investigators measured promotion of immunity~     parameters , including Cytotoxicity, Cytokine (IL-1β, IL-2, IL-4, IL-10, IL-12, IFN-γ,~     TNF-α).~   "
57482|NCT02814604|"~     There is a lot of confusion when it comes to understanding nutrition information on food~     packages, thus making it difficult for consumers to choose healthy products. In today's busy~     and fast-paced shopping environment, mobile digital technology (for example, Smartphone~     applications) can help consumers make 'healthier' food choices when they are shopping. This~     study will investigate whether a traffic light front-of-pack system or an overall star rating~     system, coupled with an automated healthfulness comparison feature, on a Smartphone app can~     help consumers identify and purchase healthier foods.~   "
57483|NCT02814591|"~     In this study spatially offset Raman spectroscopy (SORS), which allows the collection of~     Raman spectra through turbid media, is being applied to collect Raman spectra of bone. The~     principal aim to find ways to use Raman spectroscopy to assess bone quality in vivo.~   "
57486|NCT02814552|"~     Hypertension (HTN) is a major risk factor for coronary heart disease (CHD), heart failure,~     kidney failure and stroke. Disparities in HTN prevalence, treatment and control in the US~     have persisted for decades. The prevalence of HTN is 44% among Blacks, which is among the~     highest rates in the world. Those in ethnic/racial, rural, socioeconomically disadvantaged~     and other medically underserved populations are known to have the worst blood pressure (BP)~     control. Awareness of, treatment for, and control of HTN is not optimal, and varies according~     to race, whereby BP is controlled in ~53% of non-Latino Whites, 42% of non-Latino Blacks and~     only 34% of Latinos. Fundamental underlying differences in the pathophysiology contribute to~     HTN among different race groups. The United States (US) 2014 HTN recommendations outline~     race-based pharmacotherapy care for HTN. However, these recommendations use race-based~     population assumptions for Whites and Blacks only, do not include Latino ethnicity and have~     no accompanying guidelines or tools for successful implementation, particularly in rural~     primary care practices where disparate populations are common. Moreover, these~     recommendations only apply to initial therapy and lack guidance on subsequent regimen~     selection. The Optimizing Precision of HTN Care to Maximize BP Control Pilot (OPTI-BP Pilot),~     will directly address a long known and growing health disparity concern in the US which~     includes higher rates of death from CHD and stroke among Blacks and the poorest rates of HTN~     control among Latinos. Utilizing a mixed methods approach, the overarching goal of OPTI-BP~     Pilot is to test, using a pragmatic trial design, a personalized, algorithmic-based HTN~     management approach focused on age, race, biomarker (plasma renin activity) and treatment~     factors. The investigators hypothesize that implementation of a precision-based approach to~     the care of HTN in the community will improve BP reduction and ultimately reduce risk for~     CHD, stroke and death among those most affected by HTN.OPTI-BP Pilot is significant because~     it will utilize an innovative, systematic, precision-focused HTN management approach in an~     underserved, diverse population where BP control is currently suboptimal and lays the~     infrastructure groundwork for broad implementation across all areas of the US to minimize HTN~     related disparities and improve HTN outcomes.~   "
57487|NCT02814539|"~     The purpose of the study is to determine whether the neurodevelopmental outcome and in~     particular executive functions in 9 to 11 year old school children with congenital heart~     disease who underwent cardiopulmonary bypass surgery during their first three months of life~     is impaired in comparison to healthy children at same age. Executive functions are higher~     order cognitive functions and critical for school success.~   "
57488|NCT02814526|"~     This study evaluates the effects of physical exercise on cognition, functional status, brain~     atrophy and blood flow, and cerebrospinal fluid biomarkers of Alzheimer's disease in adults~     with a mild memory impairment.~      Half of participants will participate in a stretching-balance-range of motion exercise~     program, while the other half will participate in a moderate/high aerobic training program.~   "
57489|NCT02814513|"~     In this feasibility study, the researchers would like to investigate whether it is feasible~     to apply the ANDAGO V2.0, a new mobile robot for body-weight supported gait training~     (developed by Hocoma AG) to children and adolescents undergoing neurorehabilitation. The~     investigators will explore several outcomes and will compare some outcomes between the~     children and adolescents when they walk in the ANDAGO or with their regular walking aids.~   "
57490|NCT02814500|"~     An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the~     pharmacokinetics characteristics of DP-R212~   "
57491|NCT02814487|"~     Multiple Sclerosis Functional Composite score (MSFC) is one of the gold standard for multiple~     sclerosis (MS) patient clinical evaluation. However, its practical implementation is not~     always optimal as it can prove to be very time consuming. Moreover, it often constrains the~     range of tests used and is not a particularly good marker for patient real life disability~     status.~      A mobile application called Digital Self-Assessment for Multiple Sclerosis (DAM) was~     developed in order to replicate each of MSFC tests available in order to assess MS~     progression in the patient environment.~   "
57492|NCT02814474|"~     Starvation and metabolic stress increase circulating ketone bodies, potentially providing the~     heart with an alternative oxidative fuel. Hyperketonemia reduces myocardial fatty acid~     consumption. It is unclear whether this is due to inhibited peripheral lipolysis or~     diminished uptake per se.~      Aim: To test whether infusion of 3-hydroxybutyrate (BHB) inhibits myocardial glucose and~     fatty acid uptake.~      Methods: Randomized, single blinded, cross-over interventional study in 8 healthy volunteers.~     Myocardial glucose and fatty acid metabolism studied by 11C-palmitate and 18F-FDG PET/CT.~     Experimental elevation of circulating ketone bodies by infusion of~     β-hydroxy-β-methylbutyrate.~   "
57493|NCT02814461|"~     To determine the maximal tolerated dose (MTD) of axitinib in combination with RT for advanced~     HCC.~   "
57494|NCT02814448|"~     The purpose of this study is to test two innovative devices, the CryoPen® and~     thermocoagulator, against gas-based cryotherapy to determine whether the novel devices~     produce equivalent or improved destruction of cervical tissue compared to gas-based~     cryotherapy. Tissue destruction with single freeze versus double freeze treatments with the~     CryoPen and gas-based cryotherapy will also be compared.~   "
57495|NCT02814435|"~     Inherited retinal degeneration (IRD) is a major cause of blindness and partial loss of vision~     cases in the UK and starts at an early age. The purpose of this observational study is to use~     the results of two questionnaires and a computerised test testing contrast sensitivity, to~     assess the impact of IRD on quality of life. This study will involve collecting data from~     patients with IRD, but also collecting data from normal controls.~   "
57496|NCT02814422|"~     Because of the rapid aging of the global population, dementia has become a serious problem,~     and Alzheimer's disease (AD) is the most common cause of dementia. AD is pathologically~     characterized by substantial neuronal loss and chronic inflammation that is associated with~     cerebrovascular and parenchymal accumulation of proteinaceous deposits enriched in~     amyloid-beta (Aβ). More recent evidence shows it is due to an increased blood-to-brain~     delivery of circulating Aβ, and significant peripheral Aβ metabolism occurs in association~     with post-prandial triglyceride-rich lipoproteins.~      In the prodromal stage of AD, patients usually suffer mild cognition impairment (MCI). The~     annual conversion rate of MCI to AD is around 10%, and within 3 years, around 30%−50% of~     these develop dementia. Brain atrophy is an irreversible brain disease that causes problems~     with cognitive and memory functions in many diseases, such as MCI and AD, etc. In order to~     allow preventive intervention for AD, MCI must be diagnosed as early as possible, using~     biomarker assays or simple imaging modality. From 2009-2013, the investigators have~     registered 4,492 patients with atherosclerotic vascular diseases (AVD). In addition, the~     investigators have also registered 8,209 cases with no evidence of AVD, but with at least 1~     cardiovascular risk factor. In this 5-year project, 300 male or female patients with stable~     symptomatic AVD over 20 years of age, and the other 600 patients with no evidence of AVD but~     with at least 1 CV risk factor, will be enrolled from our previous registry program. The~     baseline and yearly follow-up study will include clinical examination, neurocognitive~     function evaluation, and laboratory tests (TC, HDL-C, LDL-C, TG, hs-CRP, and Aβ-40, Aβ-42,~     tau protein, and other biological signatures: adiponectin, MMP-3, MMP-9, IL-6, Fibrinogen,~     Lp-PLA2, 8-Isoprostane, hFABP, sVCAM-1, sICAM-1, CA-125, MCP-1, TNF-α, cTnI, NT-proBNP, CNP,~     NGAL).~      The purposes of this 5-year project are (1) to clarify the association of triglyceride-rich~     lipoprotein and the development of dementia; (2) to validate the diagnostic power and~     prognostic implication of ultra-low-concentration biomarkers (Aβ−40, Aβ−42 and tau) for~     dementia.~   "
57498|NCT02814396|"~     Cardiovascular disease (CVD) is the leading cause of death worldwide. Most individuals with~     CVD show no evidence of disease for decades as the disease progresses before the first onset~     of symptoms, often a sudden heart attack, finally arises. The spatial repolarization~     heterogeneity within the ventricular myocardium had been proposed to represent the function~     of the heart in health and disease. Greater than normal levels of repolarization dispersion~     may allow early diagnosis of CVD. There is a growing interest in the characteristic features~     of ventricular repolarization that leads to lethal ventricular arrhythmia even with the use~     of non-antiarrhythmic drugs. The recovery time dispersion may reflect a repolarization~     heterogeneity leading to lethal ventricular arrhythmia. Previously, the investigators had~     utilized a 64-channel low-TC SQUID MCG device to develop and verify 2 parameters, so called~     smooth index of QTc (SIQTc) and T wave propagation (TWP), to accurately detect and localize~     the myocardial ischemia. Recently Nakai, et al. reported that a newly developed 187-ch~     signal-averaged vector-projected ECG (187-ch SAVP-ECG) could evaluate low-amplitude~     high-frequency potentials and repolarization heterogeneity. In this project, the~     investigators'll try to modify and improve the spatial resolution of ECG signals from a~     Self-built-in multichannel ECG system with a newly developed algorithm, and also try to~     derive the SIQTc and TWP from this system, for early detection of CVD. The investigators~     intend to prove the concept that this newly developed multichannel ECG system could~     efficiently detect or diagnose CVD with acceptable sensitivity and specificity, and in a~     portable way.~   "
57499|NCT02814383|"~     Extremely low birth weight (ELBW), birth weight less than or equal to 1000 g, infants are at~     high risk for developing brain injury in the first week of life. Intraventricular hemorrhage~     (IVH) and periventricular leukomalacia (PVL) are the most common injuries in this group of~     infants. Their incidence is inversely proportional to gestational age (GA) and birth weight~     (BW). These lesions are associated with neurodevelopmental delay, poor cognitive performance,~     visual and hearing impairment, epilepsy, and cerebral palsy; and instability of systemic~     hemodynamics during transition from intra- to extra-uterine life and during the early~     neonatal period is believed to be at their genesis. While the incidence of ultrasound-~     diagnosed cystic PVL has decreased dramatically over the last 2 decades, diffuse PVL detected~     by magnetic resonance imaging (MRI) is still prevalent in survivors of neonatal intensive~     care. Moreover, PVL, even when non-cystic, is associated with decreased cortical complexity~     and brain volume and eventual neurocognitive impairment.~      Currently, clinicians lack the tools to detect changes in cerebral perfusion prior to~     irreversible injury. Unfortunately, the incidence of brain injury in ELBW infants has~     remained relatively stable. Once translated to the bedside, the goal of this research is to~     develop a monitoring system that will allow researchers to identify infants most at risk for~     IVH and PVL and in the future, intervention studies will be initiated to use the changes in~     cerebral perfusion to direct hemodynamic management.~      The purpose of this study is to first understand the physiology of brain injury and then to~     eventually impact the outcomes in this high-risk group of infants by assessing the ability of~     the diastolic closing margin (DCM), a non-invasive estimate of brain perfusion pressure, to~     predict hemorrhagic and ischemic brain injury in ELBW infants. The information collected for~     this study will help develop algorithms or monitoring plans that will maintain the~     appropriate brain perfusion pressure and thereby, prevent severe brain injury.~   "
57500|NCT02814357|"~     Double-blind, randomized, controlled, cross-over design with 3 test products and one control~     product.~      To evaluate the effect of 4 different flour compositions (guar gum 2% and 4%, chickpea flour~     15% and barley flour 2% and 5%) of selected fibres and flours, on post-prandial plasma (PPG)~     and serum insulin levels in healthy Indian subjects, after the consumption of flat bread made~     from 100 gram of flour compositions.~   "
57501|NCT02814344|"~     The original aspect of the methodology proposed for this study concerns the use of as many as~     16 electrodes to study the propagation and coordination (or synchronization) of uterine~     contraction. Over the last two years, the Compiègne University of Technology and the~     University of Reykjavik (Iceland) teams have developed the tools required to obtain good~     quality signals during electrohysterography and have worked on filtering and mapping of~     uterine electrical activity derived from these signals.~   "
57502|NCT02814331|"~     This study is designed to evaluate the contribution of multimodal high-resolution EEG-NIRS~     electrical and local haemodynamic analysis (HR-EEG, HR-NIRS) to spatial localization of~     epileptogenic foci in order to perform multimodal mapping and localization of interictal~     spikes (by HR-EEG source reconstruction) with the clinical prospects of guiding the SEEG~     electrode implantation strategy prior to surgery in children with drug-refractory partial~     epilepsy.~   "
57503|NCT02814318|"~     The aim of this project is to identify the duration of vancomycin administration at which~     group B streptococcus (GBS) colonization is eradicated from the vaginal and recto-vaginal~     mucosa. This will aid in labor management and delivery planning to ensure that the mother~     receives adequate GBS prophylaxis while also minimizing the duration of exposure to~     vancomycin. In addition, this could prevent unnecessary prolonged hospitalization or septic~     workup of neonates whose mothers received vancomycin intrapartum.~      This study aims to identify the time after administration of IV vancomycin at which GBS~     colonies are 100% eradicated.~   "
57504|NCT02814305|"~     Background: Overdose deaths from prescription opioid analgesics quadrupled from 4,000 cases~     to nearly 17,000 cases annually during 1999-2011. Most people who misuse or abuse~     prescription opioids obtain these pills from friends or family members who have surplus~     medication left over from prior prescriptions. There is little published data on surplus~     opioid analgesics remaining after patients recover from painful procedures. Even less is~     known about patients' willingness to dispose of these leftover pills.~      Aims: 1) Measure the impact of a risk education intervention and a financial incentive~     intervention on patients' willingness to dispose of surplus opioids left over after~     outpatient dental surgery. 2) Measure the number and proportion of opioid pills left unused~     after outpatient dental surgery.~      Methods: The study will be a pilot randomized controlled trial. Adult patients at the Penn~     Dental Care Center will be enrolled prior to elective outpatient dental surgery. Patients~     will be randomized to a control group, an educational intervention, or a financial incentive~     intervention. The primary outcome of the trial is the proportion of patients in each arm that~     express willingness to return their unused opioids. Secondary outcomes include patient use of~     prescribed opioids and their number of unused pills. These outcomes will be measured using~     novel text-message based data collection software that patients will interact with using a~     web-enabled cellular telephone or tablet.~   "
57505|NCT02814292|"~     Validation of the PEFS to detect breast tumors will be performed by means of a prospective~     trial. Subjects will participate for 1 clinic visit. Readings from the PEFS will be studied~     for reproducibility and predictive ability. Data analysis will be iterative, moving on with~     each modification of the device until the final prototype is created.~   "
57508|NCT02814253|"~     This study is being done to collect information that will be used in the development of a new~     medical device. The new device is intended to help people with COPD to monitor their~     condition at home on a daily basis.~      The device used in this study is called a capnometer. Different types of capnometer have been~     in use by doctors for many years. Capnometers measure the amount of carbon dioxide in your~     breath. The device that is used in this study is called the N Tidal C. It is a small,~     battery-powered personal device for you to use indoors either at home, at work or in~     hospital.~      The study fits around the normal treatment, tests and medication of COPD patients and there~     will not be any changes made to the treatment of any study participants.~      The study lasts for six weeks. Standard care clinical assessments will be taken at the start~     of the study, after 2 weeks, 4 weeks and 6 weeks. The tests for COPD include a check-up by~     the study doctor or nurse including the usual spirometry and blood gas tests. Each assessment~     visit will last for between 15-20 minutes.~      At the start of the study each participant will be trained in the use of the device and they~     will be asked to use the device to record their normal relaxed breathing, 3 times a day~     (morning, afternoon and evening) every day for the 6- week period. A reading takes~     seventy-five seconds of ordinary breathing through the device.~      Participants who feel unwell, or have an infection, will be asked to take more frequent~     breath records of up to six times a day if possible. This would be twice in the morning,~     twice in the afternoon and twice in the evening, leaving at least an hour between readings.~      Participants will also be asked to complete a simple daily diary of how their health and COPD~     changes and information on the use of the device.~      Participants will receive a telephone call 2 weeks after their last assessment visit to check~     how they are and to ask if any of their medicines have changed.~      Participants will not benefit directly from taking part in this study and the device used in~     the study does not provide any feedback to them. The information we get from this study will~     help us to develop the device, and to learn more about the treatment and management of COPD.~   "
57509|NCT02814240|"~     The investigator put forward the hypothesis that liver fat mass in patients with pituitary~     gland failure is greater than that in a control population. Failure of the anterior pituitary~     and more particularly impaired production of growth hormone (GH) could be the principal~     mechanism responsible for increased liver fat mass in these patients.~   "
57510|NCT02814227|"~     Obstructive sleep apnea (OSA) is the most common type of sleep apnea. OSA affects an~     estimated 18-40 million adults and 0.7-3% of all children in the US. The marketplace~     currently does not have an affordable, easy-to-use, over-the-counter, home-based OSA~     screening device. An affordable, available, FDA-approved and easy-to-use over-the-counter OSA~     screening tool would allow greater screening of at-risk individuals, especially in~     underserved communities with low socioeconomic status, hopefully encouraging a greater~     proportion of such individuals to seek treatment for their condition. The specific goal of~     this project is to compare the Zansors® micro sleep sensor screening device against~     gold-standard polysomnography to establish the device's preliminary validity to screen for~     OSA accurately.~   "
57511|NCT02814214|"~     The purpose of this study is to collect simultaneous surface electrocardiogram (ECG)~     recordings and Cardiac Resynchronization Therapy (CRT) intracardiac electrogram (IEGM)~     recordings of variations in electrical synchrony.~   "
57512|NCT02814201|"~     Action slowing has been demonstrated in many diseases. Parkinson's disease (PD) and~     Huntington's disease (HD) are two neurodegenerative diseases affecting the basal ganglia,~     particularly the medial globus pallidus, and the clinical expression of these two diseases is~     characterized by a combination of motor and cognitive disorders, but with two opposing~     patterns of dysfunction. Action slowing has been demonstrated in both of these diseases and~     has been extensively studied in Parkinson's disease, suggesting a perceptive-cognitive~     origin. Far fewer studies have been conducted in Huntington's disease. However, all of these~     studies were performed with different methodologies in small cohorts and the value of the~     proposed study is to use a validated and standardized computerized mental chronometry~     paradigm, providing a better understanding of the mechanisms of action slowing in these two~     diseases and to more clearly define a disease-specific profile.~   "
57513|NCT02814188|"~     Carbohydrate ingestion, in particular fructose, has been shown in a handful of previous~     studies to elicit a thermic effect and increase core body temperature after ingestion.~     Carbohydrate foods and supplements are commonly consumed prior to endurance running~     competition, including situations where an athlete's ability to dissipate body heat is~     compromised. Thus, there is some potential for pre-exercise carbohydrate ingestion to have a~     deleterious effect on body heat regulation in hot and humid environments. Thus, this projects~     aims to study the effects of pre-exercise carbohydrate ingestion on core body temperature,~     perceived thermal stress, and perceived exertion during high-intensity running.~   "
57514|NCT02814175|"~     An interventional Phase 4 open-label, randomized, controlled, parallel-group, multi-country~     study in subjects with psoriatic arthritis (PsA) consisting of 2 parts: Part 1 is designed to~     compare the achievement of minimal disease activity (MDA) between subjects randomized to~     either adalimumab in combination with methotrexate (MTX) or MTX alone escalated to the~     highest recommended or tolerable dose; Part 2 is to evaluate the maintenance or achievement~     of MDA on four different treatment regimens using adalimumab and/or MTX, with subject~     allocation based on the initial randomized treatment and achievement of MDA in Part 1, and~     with rescue treatment option.~   "
57515|NCT02814162|"~     The purpose of this study is to evaluate the predictive value of serum adiponectin levels in~     aneurysmal subarachnoid hemorrhage patients.~   "
57516|NCT02814149|"~     The aim of this prospective cohort study is to compare the esthetic, clinical and~     patient-centered outcomes following immediate and delayed implant placement protocols.~   "
57517|NCT02814136|"~     Ablation of atrial fibrillation is an established method for treatment of subjects with~     atrial fibrillation with goal of restoration of sinus rhythm. Among different methods, wide~     area circular ablation (WACA) is shown to provide the same results with fewer complications.~     This project will compare WACA with extra-wide area circular ablation (E-WACA) in subjects~     who are considered for ablation of atrial fibrillation.~   "
57528|NCT02813993|"~     Recent evidence has shown that young people that want to have children have low fertility~     knowledge. This study evaluates the efficacy of a video intervention on fertility knowledge,~     on changes in lifestyle and on the decision to start to get pregnant.~   "
57529|NCT02813980|"~     The investigators believe epilepsy alters the way the body controls blood pressure, heart~     rate and breathing, and these changes increase the risk of sudden unexpected death in~     patients with epilepsy (SUDEP). SUDEP-7 is a risk scoring tool which may correlate with these~     changes to the heart and blood vessels. This research study measures those differences which~     may help identify new markers to help predict those patients at greatest risk in the future.~   "
57530|NCT02813967|"~     This was a randomised, multicenter, phase 3 trial. Patients who were age of 70 years or older~     with histologically confirmed esophageal cancer were randomly assigned to S-1 concurrent with~     radiotherapy or radiotherapy alone.The primary endpoint was overall survival.~   "
57518|NCT02814123|"~     The closed-loop delivery system is composed of an insulin pump, a continuous glucose sensor~     and a dosing algorithm that calculates the insulin dose to infuse based on sensor readings.~     Pramlintide is a drug and an analog of amylin, a hormone that is co-secreted with insulin in~     healthy individuals, and is deficient in people with type 1 diabetes. Co-injection of~     pramlintide with insulin at meal times improves glucose control in type 1 diabetes.~     Literature data suggests that regular insulin may better match the effect of pramlintide~     compared to rapid insulin in regulating post-prandial glucose levels.~      The purpose of this study is to compare the effectiveness of 3 strategies to control your~     day-and-night glucose levels:~        1. rapid insulin-alone closed-loop delivery;~        2. rapid insulin-plus-pramlintide closed-loop delivery;~        3. regular insulin-plus-pramlintide closed-loop delivery.~      The primary hypotheses are:~        1. During closed-loop control, the simultaneous basal-bolus infusion of pramlintide and~          fast-acting insulin improves glucose control compared to fast-acting insulin-alone~          infusion.~        2. During closed-loop control, the simultaneous basal-bolus infusion of pramlintide and~          regular insulin improves glucose control compared to fast-acting insulin-alone infusion.~   "
57519|NCT02814110|"~     Importance: Currently the gold standard treatment for ambulant patients is corticosteroids.~     Granulocyte colony-stimulating factor (G-CSF) has been reported to exert the proliferation of~     satellite cells, the regulation of myoblast proliferation, and the differentiation and~     promotion of muscle regeneration and repair.~      Objectives To evaluate the safety and efficacy of G-CSF in children and adolescents with~     muscular dystrophies Duchenne muscular dystrophy, Becker muscular dystrophy ,~     Fascioscapulohumeral dystrophy.~      Design, Setting, and Participants: Patients aged 5-15 with diagnosed muscular dystrophies~     will be included in an open study. Patients wheelchair-bound and and mobile and~     self-independent can participate in the study. Patients also treated with steroids can~     participate in this study. Clinical examination and physiotherapeutic and laboratory tests~     will be perform. G-CSF (5mcg/kg/body/d) is given subcutaneously for five consecutive days~     during the 1st, 2nd, 3rd. 6th and 12th months. Manual muscle testing (Lovett test) of the~     upper and lower extremities, isometric force with the hand dynamometer, and the 6MWT (six~     minute walk test) are measured before and after therapy.~   "
57520|NCT02814097|"~     This is a multi-center, randomized, double-blind, placebo-controlled study in subjects with~     stable heart failure with preserved ejection fraction (HFpEF) to evaluate the effects of 4~     weeks treatment with subcutaneous MTP-131 (elampretide) on left ventricular function.~   "
57521|NCT02814084|"~     The question this research project wants to explore is whether using the Prevena Incision~     Management System (Prevena) will improve sternal wound edge oxygenation in patients~     undergoing Coronary Artery bypass surgery with Bilateral Internal Mammary Artery grafts.~   "
57522|NCT02814071|"~     Acute pancreatitis (AP) in children has an increasing incidence and is at times associated~     with significant morbidity and mortality. Despite this, there is no high-quality~     evidence-based treatment for childhood AP and current practice is based entirely on~     historical approach and extrapolation from adult studies.~      In this study, we evaluate the use of early enteral feeding in children with AP. The~     traditional approach to treating AP relies on fasting and intravenous fluids (or occasionally~     parenteral nutrition) assuming that this minimizes stimulation of an already inflamed~     pancreas. Contrary to this, evidence exists that early feeding of patients with AP may be~     beneficial. Randomized controlled trials of fasting vs. early oral diet in adult patients~     with mild AP, showed no differences in pain, serum amylase and CRP levels, but also shorter~     hospital stay in those fed earlier. Further data in adults with severe AP demonstrated that~     early enteral nutrition was associated with decreased mortality, infections and multiorgan~     failure. These benefits were lost if enteral nutrition was commenced 48 hour after admission.~     Suggested explanations for these findings include the possibility that enteral nutrition may~     maintain integrity and function of intestinal mucosa and reduce gut-origin sepsis.~      Historically, nasojejunal (NJ) feeds were felt to be safer than oral or nasogastric feeds in~     the setting of AP by avoiding cephalic and gastric pancreatic stimulation. NJ feeds require~     moderately invasive tube insertion under radiographic or endoscopic guidance. Recent data~     suggest that oral feeding with a low fat diet was as safe as NJ feeding.~      Several animal models of AP demonstrate that the exocrine pancreas is resistant to~     cholecystokinin (CCK) stimulation after the onset of AP, suggesting a mechanism for the lack~     of concern of exacerbating pancreatitis with enteral feeds.~      Considering this data it is less certain that diet and fat restriction contribute to~     treatment of AP. To further challenge the prior conceptions of AP management it is necessary~     to explore the use of unrestricted diet (full fat) in mild-moderate pediatric AP, a~     population with recognized low complication risk.~      Despite the mounting evidence to the contrary, it is still standard clinical practice to fast~     children with AP, and only slowly reintroduce feeds depending on the clinical improvement.~     This is largely due to the lack of clinical interventional studies in children with AP.~   "
57523|NCT02814058|"~     The purpose of this study is to evaluate the pharmacokinetics of the new formulation of~     zolpidem hemitartarate orodispersible tablet 1.75 mg in male and female healthy volunteers.~   "
57524|NCT02814045|"~     Alzheimer's Disease (AD) is the most prevalent neurodegenerative disease, manifested as an~     initial deficit of episodic memory that evolves into a global cognitive and psychosocial~     dysfunction and which prevalence is increasing around the world. Sleep disturbance is~     frequent since early stages of the disease and sleep fragmentation had been demonstrated~     increase the production of amyloid peptide (AB) (main pathological hallmark) in non-demented~     population. Obstructive Sleep Apnea (OSA), which consist in intermittent hypoxia and sleep~     fragmentation, is a major health problem with multiple systemic effects and it's very~     prevalent in AD. However, the influence of this comorbidity on the cognitive evolution of AD~     patients remains unknown. The investigation of neurobiological markers and sleep recording~     may reveal potential mechanisms of neurodegeneration and explain the influence of sleep~     fragmentation and/or hypoxia on cognitive decline.~      To fill those gaps, investigators will perform a multidisciplinary and translational project~     to assess the progression of symptoms in AD patients, diagnosis of sleep disturbance and new~     biomarkers of progression of the disease.~      The present proposal is going to be developed by coordination of different expertises that~     will be range from the clinical research conducted by a medical neurologist, to the animal~     model and most molecular work, to be done by an experimented group in mouse work.~   "
57525|NCT02814032|"~     Thyroid carcinoma is the common endocrine system malignant neoplasm. At present it has become~     the malignant neoplasm of fastest growing incidence rate. More than 85% thyroid carcinoma is~     papillary thyroid carcinoma. Cervical lymph node metastasis is common in papillary thyroid~     carcinoma patients. This study aim to reveal protein expression differences between papillary~     thyroid carcinoma with cervical lymph node metastasis and without cervical lymph node~     metastasis.~   "
57526|NCT02814019|"~     The purpose of the study is to assess the efficacy of idebenone in delaying the loss of~     respiratory function in patients with DMD receiving concomitant glucocorticoid steroids~   "
57527|NCT02814006|"~     This study will asses the effectiveness of two strategies for timed intercourse in couples~     actively trying to conceive~   "
57531|NCT02813954|"~     Amniotic fluid (AF) is a complex structure with a changing content by gestational time. AF pH~     can be affected by both maternal and fetal conditions such as preterm ruptures of membranes,~     prematurity and fetal distress. While fetal urine is the major content of AF since 20th~     gestational week, fetal lung liquid (FLL) also acts as a minor content. Secretion of FLL~     depends on chloride transport and postnatal clearance of FLL is provided by active~     reabsorption of sodium (Na) ions. Down-regulation of epithelial Na channels (ENaCs) and an~     increase of pulmonary compliance accompany to pulmonary adaptation developing at the first~     hours of life. Lower genomic expression of Na channels in airways is shown to be associated~     to respiratory distress syndrome (RDS) in preterm. Although pH and electrolyte value of AF is~     thought to be relevant to fetal and maternal conditions such as gestational age, antenatal~     steroids and preterm birth, there is no study about this topic in the literature.~   "
57532|NCT02813941|"~     Background: Summary of Findings (SoF) tables have been developed to present results of~     systematic reviews in a concise and explicit format. Adopted by many review groups including~     the Cochrane Collaboration, the Agency for Healthcare Research and Quality (AHRQ), and the~     GRADE Working Group; SoF tables provide succinct, transparent, and easily interpretable~     judgments about the certainty of evidence and magnitude of effects. Currently, there are~     three different SoF formats in use. This study aims to compare SoF table formats in terms of~     understanding, accessibility, satisfaction, and preference with systematic review users.~      Methods: The primary objective of this three-arm randomized controlled non-inferiority trial~     is to investigate whether an alternative GRADE-SoF table, or EPC-SoF table, is noninferior to~     the current GRADE-SoF table in the understanding of information presented to systematic~     review users. Researchers, clinical practice guideline developers, policy-makers, end-users,~     or knowledge transfer will be recruited. Data will be collected electronically at baseline~     and after randomization. Noninferiority would be declared if the difference in the proportion~     of participants who understand the information displayed in the alternative SoF table is 10%~     or less.~      Discussion: This study aims to assess the understanding, accessibility, satisfaction, and~     preference between three SoF tables for displaying summary evidence from health-related~     outcomes. The results of this study will provide important knowledge to understand what~     information should be included in SoF tables in systematic reviews.~   "
57533|NCT02813928|"~     Inspite of curative treatment 30-50% patients with ColoRectal Cancer (CRC) develop tumor~     relapse during the first 3 years after treatment of the primary tumor. Treatment of relapses~     is based on surgical resection, when possible, chemotherapy and targeted therapies. To detect~     recurrences or metastases, a surveillance strategy is recommended for patients able to~     withstand complementary treatment during a five-year period. Over this period, the~     probability of one false-positive result is 87%. Considering that less than 10% of recurrent~     patients are suitable for potentially curative treatment and that more intensive programs~     enable an increase of the overall rate of curative resection but do not result in reduced~     mortality, less time and cost-consuming, tailored follow-up is necessary. The level of~     circulating ccfDNA, defined as extra cellular DNA, increases in CRC patients. The Inplex®~     method could validate the use of ccfDNA as a cancer biomarker in terms of prognosis and~     surveillance.~      Tubes for ccfDNA analysis will be taken during medical examination at the same time of the~     CEA dosage (if it was not made before the consultation). Cryotubes of plasma will be sent for~     analysis in the laboratory INSERM (National Health Institute) of Montpellier and the~     remaining plasma will be kept in biological collection.~      Patients will have a consultation of follow-up every 3-4 months during which the dosage of~     CEA and ccfDNA will be realized as well as a medical examination, a general examination~     (weight, size, and blood pressure), an evaluation of the indices of performance status and a~     nutritional evaluation in case of loss of weight.~   "
57534|NCT02813915|"~     The investigators would like to study cardiac output, stroke volume, and fluid responsiveness~     on young adult pediatric patients undergoing anesthesia and surgery with the use of the~     NICOM, a non-invasive monitor. The NICOM method is non-invasive and provides reliable~     trending of cardiac output and stroke volume. Measuring cardiac output in conjunction with~     routine monitoring will provide a better assessment of intra-operative status.~   "
57535|NCT02813902|"~     This proposal describes a pilot study to gather preliminary evidence of efficacy,~     tolerability and toxicity of oral PLE among a high-risk skin cancer population for the~     prevention of Actinic keratosis (AKs) and keratinocytes (KCs) to gain insight into optimal~     methods for recruitment, intervention development, data collection, and promoting protocol~     adherence prior to conducting a fully powered trial. The primary clinical outcome is AKs as~     measured by a clinical dermatologist, with skin cancer as a secondary clinical outcome. The~     investigators will also assess histologic markers of Ultra Violet (UV) damage, which have~     previously been shown to be reduced with oral PLE use in human studies, namely formation of~     UV-induced cyclo pyrimidine dimer positive cells and number of sunburn cells among epidermal~     keratinocytes. Results generated from this proposal will form the foundation of a fully~     powered clinical trial of the effect of PLE on the risk of AKs and KCs. The results may also~     provide information about this promising dietary supplement which may provide extra~     protection for a high-risk skin cancer population.~   "
57536|NCT02813889|"~     The study aims to develop a SmarToyGym where sensitized, wireless toys are strategically hung~     and placed within reach of infants to elicit toy-oriented body and arm/hand movements. Each~     toy will be equipped with sensors capable of measuring the infant's grasping actions such as~     squeezing, pinching, tilting, etc.~      A low-cost 3D motion capture system will be used to collect video data and the infants'~     reaching and body kinematics in response to the toys. A pressure mat will be used to measure~     postural changes to detect weight shifts, rolling, crawling and other movements away from the~     initial posture. By capitalizing on these wireless and low-cost technologies, it will permit~     the regular and non-invasive monitoring of infants, which can lead to detailed,~     non-obtrusive, quantitative evaluation of motor development. In this vein, the investigators~     also aim to conduct proof-of-concept testing of the SmarToyGym with atypical and typical~     developing infants. The investigators will include infants' ages 3 to 11 months who are~     categorized as high-risk or low-risk using the Bayley Infant Neurodevelopmental Screener.~   "
57537|NCT02813876|"~     Prospective randomized-controlled trial evaluating impact of enhanced recovery protocol~     compared to standard care for recovery of patients with acute pancreatitis.~   "
57540|NCT02813837|"~     This single arm, open-label, multi-center clinical trial is studying CD19 targeted chimeric~     antigen receptor T cells therapy in treating patients with CD19 positive malignant B-cell~     derived leukemia and lymphoma that is relapsed (after stem cell transplantation or~     chemotherapy) or refractory to chemotherapy.~   "
57541|NCT02813824|"~     The proposed trial will evaluate the effect of aspirin 300 mg/d and 100 mg/d during 4 years~     vs placebo, in a 4 groups randomised parallel design in Lynch syndrome patients: patients~     with proven carriers of pathological mutations in mismatch repairs genes and patients with~     personal and family history characterizing Lynch syndrome according to modified Amsterdam~     criteria without proven mutation, aged more than 18 years with signed informed consent. The~     main hypothesis to be tested is that aspirin could decrease colorectal adenoma recurrence~     evaluated during high quality follow-up by colonic chromo-endoscopy in Lynch syndrome~     patients. The trial will also explore: (i) colorectal neoplasia recurrence according to~     different germline alteration in mismatch repair genes, (ii) observance to chemoprevention in~     Lynch syndrome patients, (iii) the burden of adverse events attributable to aspirin in Lynch~     syndrome patients, (iv) the dose-effect of aspirin on adenomatous polyp burden. All~     pathological samples will be reviewed using a centralized procedure. The INCA regional~     network organization and the HNPCC patient organization will allow the recruitment and the~     follow-up of a large number of patients with well characterised Lynch syndrome.~   "
57542|NCT02813811|"~     Temperature-controlled Laminar Airflow (TLA) treatment delivered by the Airsonett treatment~     device is a new treatment for patients with allergic asthma.~      The LASER Trial (temperature-controlled Laminar Airflow in Severe asthma for Exacerbation~     Reduction - LASER) is a trial, currently evaluating whether the Airsonett device is able to~     reduce the frequency of asthma attacks in patients with allergic asthma.~     (www.lasertrial.co.uk)~      Participants who successfully complete at least 6 months of follow-up in the LASER trial are~     eligible for the post trial provision of 4 years of an active TLA treatment device.~      To date there is no long term performance data available to show whether there is any~     sustained benefit from the long term use of the Airsonett device, whether any improvement in~     asthma control or quality of life is maintained and whether patients will continue to use the~     treatment device beyond 12 months (the length of the longest previous trials of TLA~     treatment.)~      The investigators plan to assess the performance of the Airsonett device by recording the~     frequency of asthma attacks in patients over a 4-year period (48 months.) The investigators~     also wish to evaluate the effect of long term TLA treatment on asthma control, quality of~     life, healthcare resource use and patient acceptability of longer term use of the Airsonett~     device.~      Participants will be sent and asked to complete a series of questionnaires on a 6 monthly~     basis over the 48 month study period. Questionnaires will be returned by post to a single~     study centre based in Portsmouth, UK. Participants will also be contacted by telephone on a 6~     monthly basis by a member of the trial team to collect information about their medication,~     healthcare resource use and whether they have had any asthma attacks since their last~     contact.~      Participants will not be expected to visit the study centre during the trial.~   "
57543|NCT02813798|"~     The purpose of this study is to determine the effect of renal impairment on rivipansel.~   "
57544|NCT02813785|"~     This Phase III, multicenter, open-label, randomized, controlled study is designed to evaluate~     the efficacy and safety of the anti-programmed death-ligand 1 (PD-L1) antibody atezolizumab~     compared with docetaxel in participants with locally advanced or metastatic NSCLC who have~     progressed during or following a platinum-containing regimen. Treatment may continue until~     disease progression, loss of clinical benefit, or unacceptable toxicity.~   "
57545|NCT02813772|"~     Infant colic (IC) is responsible of 25% of pediatric consultation in the first 3-4 months of~     life affecting from 5% to 30% of infants between 2 weeks and 3 months of life (3, 4). The~     variability in the prevalence of IC reported by the several studies depends on different~     criteria used to define IC.The etiology of IC remains still unclear. Recently, the~     composition of intestinal microbiome has been addressed as an independent risk factor for IC.~     There are no uniform criteria for a specific therapeutic approach of IC. Based on these~     conclusions the objectives of our study are: to determine whether the administration of a~     partially hydrolyzed formula (pHF) with reduced lactose content and Lactobacillus reuteri, is~     beneficial in IC in reducing the infant crying duration and in prolonging the duration of~     sleeping period~   "
57546|NCT02813759|"~     To evaluate the acute effect of a preload of sucralose in presence of carbohydrate (HC)~     available on the glycemic response, postprandial C peptide and satiety in patients with type~     2 diabetes mellitus (DM2) in intensive insulin therapy (IIT).~   "
57547|NCT02813746|"~     The aim of this study is to understand the epigenetic and transcriptomic mechanisms that~     regulate the fetal origin of adult diseases (FOAD), either for the presence of metabolic~     disorders in the future mothers, such as obesity or for the exposure to certain contaminants~     such as tobacco.~      To do that, the miRNAs profiles secreted to the endometrial fluid in obese women vs~     normoweight women during the window of implantation will be identified. Likewise, it will be~     studied how that miRNA signature is normalized once a substantial loss of weight is produced~     by the patients involved in the studied. In parallel, a comparison of the miRNA expression~     profiles secreted in the endometrial fluid in smoker women vs nonsmoker women will be~     performed. As in the previous case, it will be studied if after the exposure to these~     contaminant, the normalization of the miRNA expression signature occurs. Finally, an in~     silico analysis will be carried out in order to define the target genes and the metabolic~     pathways affected by the miRNAs profile secreted in both pathological conditions~   "
57548|NCT02813733|"~     In a large prospective cross-sectional study, the investigators aimed to identify the~     determinants of thyroid surgery outcomes and quantify the relative influence of preoperative~     and intraoperative factors. For this purpose, the investigators considered the interplay of~     several characteristics specific to surgeons, patients, and surgical procedures.~   "
57549|NCT02813720|"~     Nearly 30% of patients with cutaneous psoriasis (PsO) developed psoriatic arthritis (PsA).~     Among these patients 20 % will have severe destructive arthritis. The risk of developing PsA~     is significantly higher in patients with nail involvement (OR = 2.24; 95% CI [1.26-3.98]).~     The risk is particularly high for the peripheral form of PsA and onycholysis (OR=2.80; 95% CI~     [1.34-5.85]).~      Thus the investigators wanted to test the hypothesis that onycholysis, in patients without~     PsA, is a potential clinical marker of subclinical distal enthesopathy and, by extension, of~     bone micro-structural alterations.~      Patients and Methods~      The investigators will recruit 4 groups of subjects:~        1. Patients with peripheral PsA,~        2. Patients with psoriatic nail onycholysis,~        3. Patients with PsO only~        4. Healthy match control subjects. The investigators will assess the presence of~          enthesopathy by ultrasonography and bone structural damages (by HR-pQCT) in all subjects~          at baseline and 4 years.~   "
57684|NCT02811939|"~     The overall purpose of this study is to examine the effect of Pregnenolone (PREG) on the~     acute psychosis-like and cognitive effects of Delta-9-Tetrahydrocannabinol (THC). This will~     be tested by pretreating healthy individuals with PREG, and then assessing their responses to~     Dronabinol (THC).~   "
57550|NCT02813707|"~     The World Health Organization (WHO) statistics, in 2008, there were more than 1.4 billion~     adults, aged 20 and older, and were overweight. Of these over 200 million men and nearly 300~     million women are obese. Body Mass Index (BMI) more than 30 is considered as obese and~     increasingly bariatric surgery is the commonest way used nowadays to lose weight. Moreover,~     surgery will influence many other health factors and parameters. Many studies prove the~     improvement of metabolic and psychological status of patients post bariatric surgery. In~     addition, many vitamins will be affected and should be replaced. This research study is~     continuation (PART 2) of previously approved study (approval: 13/54). Brief findings of the~     study are attached. Our aim in this part of the study to assess long term the impact of~     bariatric surgery on metabolic, nutritional and quality of life status on patients post~     bariatric procedure of at least 12 months post-surgery follow up. As we noted in our previous~     initial study that there is significant loss the collection of the data due to no show for~     proper follow up routine care. Previously it was approved to consent patients by phone calls~     and extract information regarding Quality of Life (QoL) post-surgery. This will be replaced~     by seeing the patients in the outpatient clinic and providing the necessary information and~     consent.~   "
57551|NCT02813694|"~     This study evaluates the safety and efficacy of lefamulin, a pleuromutilin, for the treatment~     of adults with moderate community-acquired bacterial pneumonia~   "
57552|NCT02813681|"~     Historically, women who have chronic back pain after pregnancy have attributed the cause to~     the epidural procedure. While many studies have shown no greater incidence of generalized~     post-partum back pain in those who received an epidural, no studies have measured localized~     pressure sensitivity at the epidural insertion site. Short-term pressure sensitivity might~     limit patient's mobility and activities in the post-partum period. Understanding the factors~     that increase insertion site pressure sensitivity will allow the investigators to modify~     epidural placement technique in order to minimize this effect.~   "
57553|NCT02813668|"~     This study will test the implementation, effectiveness, cost-effectiveness, and acceptability~     of a worksite lifestyle improvement program that includes lifestyle education classes led by~     trained individuals from the worksite and improvements in the worksite environment that will~     make it easier for employees at risk for diabetes or with unmedicated diabetes to lose~     weight, exercise more, and eat a healthier diet. A total of 2000 participants across 8~     worksites in India (4 from Delhi and national capital region [NCR] region and 4 from Chennai)~     will be involved in this study for 5 years.~   "
57554|NCT02813655|"~     The aim of the study is to assess the efficacy and safety of Synacthène® versus placebo in~     the treatment of post-dural puncture syndrome in patients receiving epidural analgesia,~     spinal analgesia, or combined spinal-epidural analgesia for labour.~   "
57555|NCT02813642|"~     To evaluate the relationships between bone mineral markers levels at dialysis start and~     vascular calcification progression during a 2 year follow up~   "
57556|NCT02813629|"~     So far, no study investigated the safety and efficacy analgesic of transcranial direct~     current stimulation (tDCS) associated to peripheral electrical stimulation (PES) in~     individuals with SCD who suffer from chronic pain. Several studies have reported a decrease~     in O²Hb concentration in the regions below the electrodes and in other cortical areas during~     anodic or cathodic tDCS, which implies a risk factor for vasoocclusive events in individuals~     with SDC due to polymerization of hemoglobin when exposed to these low O²Hb concentrations.~     For this reasion, the aim main of this study is to assess the effect of a single session of~     transcranial direct current stimulation (tDCS) associated to peripheral electrical~     stimulation (PES) on safety and efficacy analgesic in individuals with sickle cell disease~     (SCD). Others aims sencondaries are evaluate the effect of a single session of transcranial~     direct current stimulation (tDCS) associated to peripheral electrical stimulation (PES) on~     biomarkers neurophysiological and inflammatory.~   "
57557|NCT02813616|"~     Chronic constipation (CC) and Irritable Bowel Syndrome with Constipation (IBS-C) are two~     conditions difficult to manage because factors affecting dissatisfaction to treatments are~     misleading. This observational multicentric national study is aimed to assess which factors~     are related with a clinically significant improvement in patients with CC and IBS-C. Patients~     will be evaluated at baseline and after every one-month standard of care therapy with~     standardised questionnaires to assess bowel habit and satisfaction to treatments.~     Somatisation, quality of life, colonic transit time and resting anal pressure will be~     assessed at baseline.~   "
57558|NCT02813603|"~     Investigators intend to compare the 19-gauge needle and the 22-gauge-needle during EBUS-TBNA~     concerning the diagnostic yield, the quality and quantity of each biopsy needle without~     raising the rate of complications.~   "
57559|NCT02813590|"~     Ascitic fluid microbiome is going to be investigated in this study by using internal~     transcripted spacer (ITS) and 16S ribosomal RNA (rRNA) polymerase chain reaction (PCR) and~     sequencing as conventional culture methods are lacking sensitivity regarding diagnosis of~     spontaneous bacterial peritonitis (SBP).~      All patients with routinely performed ascitic fluid puncture and underlying liver cirrhosis~     are included in this study. Next generation sequencing (NGS) in ascitic fluid, skin swaps~     from puncture side and stool samples as well as conventional culture methods are performed to~     investigate the difference in the microbiome between patients with and without SBP.~   "
57560|NCT02813577|"~     The post approval study will enroll US female patients presenting with claudication or~     ischemic rest pain and an angiographically significant lesion in the superficial femoral or~     popliteal artery. Subjects are treated per Instructions For Use (IFU) with the Lutonix®~     Catheter. Subjects will have a Duplex Ultrasound (DUS) and clinical follow-up through two (2)~     years.~   "
57581|NCT02813304|"~     The primary objective of this study is to compare the short-term effectiveness (2 and 6 weeks~     following the start of the rehabilitation program), in terms of symptoms and functional~     limitations, of a rehabilitation program centered on gradual reloading to a rehabilitation~     program centered on rest and cryotherapy in individuals with acute rotator cuff tendinopathy.~     The secondary objective is to explore the effects of these programs on shoulder control~     (acromiohumeral distance), subacromial structures (supraspinatus tendon thickness) and~     central pain modulation. The hypothesis is that the rehabilitation program centered on~     gradual reloading will lead to a faster improvement at week 2 and 6 when compared to the~     program centered on rest and cryotherapy.~   "
57561|NCT02813564|"~     Plasticity refers to susceptibility of an organism to change. Cognitive training is an~     intervention approach based on the notion of plasticity. It entails the repeated exercise of~     a set of higher-order cognitive abilities over several weeks after which performance gains~     are expected on the trained as well as untrained tasks. Cognitive training has produced~     successful results in various clinical groups, but its benefits have not been explored in~     Autism Spectrum Disorder (ASD). The present study will develop a software-based training~     program tailored to the cognitive deficits in ASD. The investigators will also examine~     possible training-induced functional changes within the brain using functional Magnetic~     Resonance Imaging (fMRI). Fifty children with ASD 3-7 years will be recruited and randomly~     assigned to the control (n=25) or the training group (n=25). A subgroup of these samples will~     carry out the response inhibition and set-shifting tasks in the fMRI scanner. The study will~     consist of a pre-post design and a four-month follow up. Repeated measures Analysis of~     Variance (ANOVA) will be carried out with group (training, control) as the between subjects~     factor and Time (pre- post-training, follow-up) as the within subjects factor to identify~     training induced cognitive improvements. To determine training-induced biological changes~     within the brain, activity maps associated with response inhibition and set-shifting at~     pre-training and post-training sessions will be entered into a group ANOVA and contrasted for~     differences within- and between groups.~   "
57562|NCT02813551|"~     Currently there is no intervention to prevent persistent postpartum hypertension in~     preeclamptic women. Physiologically, the use of a pharmacokinetically predictable~     loop-diuretic is a reasonable intervention to increase elimination of extra fluid accumulated~     secondary to preeclampsia.The purpose of this study is to assess if Torsemide reduces the~     incidence of persistent postpartum hypertension in preeclamptic women.~   "
57563|NCT02813538|"~     The aim of this study is to evaluate early clotting disorders through thromboelastogram and~     anticoagulant proteins levels (maybe also endothelial markers) and liver function by~     indocyanine green clearance after major liver resection and search for a potential~     relationship between them.~   "
57564|NCT02813525|"~     Fetuses with IUGR, there is a correlation between Doppler indices of cardiovascular function~     and perinatal mortality. An index of systolic flow velocities at the aortic isthmus (ISI) has~     previously been described in a population of normal fetuses. Fetuses with IUGR, the~     velocities recorded in the aortic isthmus could be affected and the normal development of the~     ISI should be changed, because of the increase in placental resistance on one hand, and the~     gradual deterioration ventricular functions on the other one. Investigators hypothesize that~     the ISI index in the context of placental insufficiency could provide additional arguments on~     the extraction timing, the prognosis and the fetal extraction mode to severe hypoxia. The~     primary outcome of the study is to evaluate in an exploratory manner the feasibility and the~     potential interest of longitudinal monitoring of fetuses with IUGR by Doppler systolic~     isthmus and the calculation of the ISI index.~   "
57565|NCT02813512|"~     The objective of the study is to confirm the safety and possible efficacy of Adipose-Tissue~     Derived Stem Cells treatment of chronic stroke. Specifically, the study will transplant~     autologous ADSCs into brain surrounding ischemic infarct in adult (65-80 years old) subjects~     who have chronic non-hemorrhagic stroke (>6 months).~   "
57566|NCT02813499|"~     Acute coronary syndrome (ACS) is a major health problem and its diagnosis remains a challenge~     for the emergency physician. The management of a suspected ACS is well codified, based on~     troponin assays, renewed if necessary.~      Conversely, the criteria leading to initiate a diagnostic procedure in chest pain to the~     Emergency department are unclear. The fear is, firstly, to miss a potentially life treating~     diagnosis and, secondly, exposing many patients to unnecessary examinations. The advent of~     highly sensitive troponin assays also increases the risk of over-investigation by a larger~     number of elevations of the biomarker in non-coronary circumstances leading to a prolongation~     of hospitalization and, possibly, unnecessary treatments and invasive investigations.~      CARE rule could help to streamline this first step. It is established by assigning a value~     from 0 to 2 to the items: Characteristic of pain, Age, Risk factors and ECG. The search for~     an ACS is not justified if the sum of points is ≤1 (negative rule) and, conversely, a~     troponin should be performed if the sum is > 1 (positive rule).~      Indeed, CARE rule corresponds to the first 4 items of the HEART score (the latter standing~     for troponin at admission) whose reliability has been demonstrated, a ≤3 income excluding ACS~     with a risk of false negatives <2%. A negative CARE rule always corresponds to a HEART score~     ≤3.~      Our study aims to confirm the interest of CARE rule to streamline the search for an ACS in~     chest pain as an observational European multicenter prospective study.~   "
57567|NCT02813486|"~     The purpose of this study is to evaluate safety of GC3111 and to describe immunogenicity of a~     single dose of GC3111 versus Boostrix® vaccine among healthy adults in 19 to <65 years of~     age.~   "
57568|NCT02813473|"~     The SYNTAX III Revolution trial is a randomized diagnostic research study that investigates~     the use of CT scan and angiogram of the heart to help doctors decide which method is the best~     to improve blood supply to the heart in patients with complex coronary artery disease. Each~     patient will undergo an angiogram and CT scan per standard of care. The randomization~     strategy in this study is not between patients but between two teams of doctors, the~     so-called Heart Teams, will be randomized: in the first round, team 1 assesses the~     angiogram, and team 2 assesses the CT scan. Then they make a decision about which treatment~     would be the best to treat complex coronary artery disease. In the second round, both teams~     see the imaging method that they did not see in the first round, and make the decision again.~     The final decision on the clinical treatment strategy is at the sole discretion of the Heart~     Team and there are no criteria described in SYNTAXIII Revolution protocol leading influencing~     this final decision.~      Hypothesis: Determination of the best treatment strategy for coronary artery disease based on~     a CT scan will result in similar decisions as based on invasive coronary angiography.~   "
57569|NCT02813460|"~     The purpose of this study is to evaluate in a double-blinded fashion the taste and overall~     acceptability profile of different ALS-008176 oral liquid formulations as compared to the~     reference formulation (ALS-008176: 60 milligram per milliliters (mg/mL) oral suspension~     without sweetener/flavor) for pediatric clinical development and commercialization.~   "
65396|NCT02710994|"~     This is a randomized, open-label, two-way crossover study to investigate the~     pharmacodynamics(24 hour gastric pH) and the safety between repeated doses of CDFR0209 and~     Losec in Healthy Male Volunteers~   "
57570|NCT02813447|"~     Objective: Determine whether treatment of perceived stress, anxiety, and depression with~     anti-depressant therapy improves dyspnea scores, 6-minute walk (6MW) distance and quality of~     life (QoL) in patients with Chronic Obstructive Pulmonary Disease (COPD) and ILD~     (Interstitial Lung Disease) undergoing pulmonary rehab.~      The study is a prospective, randomized, double-blinded, placebo-controlled study to assess~     the effect of an SSRI on 6MW, dyspnea scores, and QoL in COPD and ILD patients undergoing~     pulmonary rehab. Thirty subjects that carry an ICD-9 code diagnosis of COPD and/or ILD and~     CES-D (Center for Epidemiologic Studies Depression) score of > 16 will be recruited from Duke~     Pulmonary Rehab.~      Multivariable regression models will be constructed to evaluate the relationship between~     perceived stress, anxiety, and depression with adjustments by race, gender, age, BMI and GOLD~     score. A multivariable regression model will be constructed to assess whether treatment of~     perceived stress, depression, and anxiety with antidepressant therapy (sertraline) is an~     effect modifier on 6MW distance and dyspnea scores in patients with COPD or ILD who are~     enrolled in pulmonary rehab.~      Descriptive statistics will be used to examine the socio-demographic characteristic data.~     Student t-tests will be performed to assess group differences in continuous data. Categorical~     variables will be examined using the Pearson's Chi-Squared test.~   "
57571|NCT02813434|"~     This study is aimed at examining the interest of amyloid radiotracer Florbetapir (18F-AV-45)~     for the etiological diagnosis of poststroke cognitive impairment and dementia. This study~     stems from two converging objectives: (1) the need to refine characteristics of vascular~     cognitive impairment (VCI) and dementia (VD) in order to propose diagnosis criteria of VCI~     and of mixed dementia and to improve diagnosis criteria of VD and (2) the need to improve the~     etiological diagnosis of poststroke cognitive impairment and dementia. It will take advantage~     from the ongoing GRECOG-VASC study (which determines the cognitive status 6 months poststroke~     in consecutive patients according to a standardized international battery) coordinated by the~     Amiens University Hospital center, the opportunity to perform amyloid imaging in vivo using~     Positron Emission Tomography (PET) and Florbetapir (a production site is located in the city~     of Amiens) and the collaboration between neurology and imaging departments of Amiens~     University hospital.~   "
57572|NCT02813421|"~     The purpose of the study is to learn more about blood glucose control when people with Type 1~     Diabetes switch to an insulin pump. The investigators hope to learn whether using a~     continuous glucose monitor (CGM) helps to create personalized insulin doses that may lead to~     stable blood glucoses and less frequent insulin pump dose changes during the transition to an~     insulin pump.~   "
57573|NCT02813408|"~     The purpose of this observational study of metastatic castration-resistant prostate cancer~     (mCRPC) participants is to explore whether or not there are differences between participants~     treated with abiraterone acetate and enzalutamide on the health-related quality of life~     (HRQoL), Fatigue, Pain, Cognitive function and medical resource use (MRU).~   "
57574|NCT02813395|"~     Objective: Investigating the immediate effects of Low Level Laser Therapy (LLLT) on~     neuromuscular performance in healthy subjects after an induced muscle fatigue protocol.~     Methods: Eighty volunteers of both genders aged between 18 and 28 years underwent a~     preliminary evaluation using surface electromyography and isokinetic dynamometer of the~     flexor muscles of the elbow. The subjects were randomly allocated into 4 groups: G1 was~     control group; G2 placebo; G3 laser applied before fatigue protocol; and G4 immediately~     after. Muscular fatigue protocol consisted of 30 maximal concentric isokinetic contractions~     at 120°/s of the elbow flexor muscles. An 808 nm equipment was used for applying laser~     therapy, with a power of 100 mW and total energy of 20 J. Volunteers were reassessed after~     interventions.~   "
57575|NCT02813382|"~     Considering fast-track principles, an ideal spinal anesthetic should have minimal~     complications and above all fast recovery so reducing in-hospital stay.~      Between 1/8/2015 and 1/1/2016, a total of 101 patients attending the surgeon's practice with~     an umbilical or unilateral inguinal hernia and no contra-indications for surgery were~     included in this study. Patients were given 10.5mg bupivacaine (B-group), 40mg hyperbaric~     2-chloroprocaïne (C-group) or 60mg prilocaïne (P-group), each with added sufentanil (2µg).~     Motor block was assessed using the Bromage scale. Sensory block was measured by determining~     the peak level dermatome. Intraoperative hemodynamic parameters were listed. Resolution of~     sensory and motor block, time to void and home readiness were defined as clinical endpoints.~   "
57576|NCT02813369|"~     This post-authorization observational safety study (PASS) monitors clinically important~     identified and potential risks within a cohort of patients treated with naloxegol, including~     the occurrence of bowel perforation, acute myocardial infarction (MI), stroke, cardiovascular~     (CV)-specific mortality, all-cause mortality, hypertension, opioid withdrawal, abdominal~     pain, diarrhea, syncope, and change in pain severity. This study is part of a broader~     post-marketing commitment to augment routine evaluation of the safety profile of naloxegol in~     clinical practice.~   "
57577|NCT02813356|"~     The overall research goal for this study is to provide additional data to characterize the~     safety of naloxegol in patients aged 18 years and older who do not have a diagnosis of cancer~     and who are treated with opioids chronically~   "
57578|NCT02813343|"~     This is a mixed methods study that evaluates the effectiveness of the BlueStar app and its~     implementation in 3 hospital/health system sites across Ontario. The 6 month study includes~     300 participants that are randomized to an immediate treatment group or a delayed~     intervention group. The primary outcomes include changes in HbA1c and patient reported~     outcomes and experience measures. Qualitative interviews with various stakeholders will~     explore issues relating to successful implementation.~   "
57579|NCT02813330|"~     To compare the effect of subcutenous sterile water injection technique with the subcutaneous~     saline injection technique in the degree and duration of low back pain-relieving during~     childbirth~   "
57580|NCT02813317|"~     This prospective, multicenter, observational study aims to explore a comprehensive approach~     to the care of early breast cancer patients in a regional health territory (including 1.5~     million women and characterized by a breast cancer incidence and mortality higher than~     national ranges), incorporating all healthcare actors inside and outside the hospital.~   "
57631|NCT02812654|"~     Prospective phase II study. Patients will be submitted to neoadjuvant chemotherapy (cT) and~     hypo fractionated radiotherapy (hRT) following by surgery. The remain viable cells will be~     analyzed and the patients whithin less than 30% will receive more 3 cycles of cT. All~     patients have deep high grade soft tissue sarcoma of extremity.~   "
57582|NCT02813291|"~     The mental repetition of movements - or motor imagery (MI) practice - facilitates motor~     learning. It allows avoiding fatigue that occurs during physical practice; this method is~     thus particularly interesting for elderly people. Transcranial direct current stimulation~     (tDCS) is a noninvasive method of neurostimulation during which a low direct current is~     applied to the brain via electrodes placed on the scalp. This method has been successfully~     used to enhance motor learning in both young and elderly subjects.~      The main aim of this study is to assess the impact of MI practice combined with tDCS on the~     learning of a complex finger sequence, in young and elderly subjects.~      For that purpose, young and elderly healthy subjects will be randomly assigned to Stimulation~     and Sham groups. There will thus be a total of four groups: Young Stim, Young Sham, Elderly~     Stim, and Elderly Sham.~      All subjects will participate to three training sessions spread over five days, and a~     retention test one week after the third training session.~      During training they will mentally repeat a complex finger sequence with the left hand, for~     13 min:~        -  Subjects of the Stimulation groups (Young Stim and Elderly Stim) will receive in~          parallel an anodal tDCS of the primary motor cortex.~        -  Subjects of the Sham groups (Young Sham and Elderly Sham) will receive in parallel a~          sham tDCS of the primary motor cortex.~      Immediately before (pretest) and after (posttest) each training session, as well as during~     the retention test, subjects will repeat the sequence as many times of possible, for 1 min.~     During these tests (pretests, posttests and retention test) electroencephalographic activity~     will be recorded to assess the Mu rhythm power.~   "
57583|NCT02813278|"~     Colorectal cancer resection is one of the most common types of abdominal surgery. Though most~     patients undergoing colorectal resection show recovery of bowel movements within a week, some~     have prolonged intestinal paralysis or postoperative ileus, resulting in decreasing patient~     comfort, increasing morbidity and mortality, a longer hospital stay and subsequent increased~     healthcare costs.~   "
57584|NCT02813265|"~     The primary purpose of this study is to determine the efficacy and safety of KPI-121 0.25%~     ophthalmic suspension compared to vehicle (placebo) in subjects who have a documented~     clinical diagnosis of dry eye disease. The product will be studied over 14 days, with 1-2~     drops instilled in each eye four times daily (QID).~   "
57585|NCT02813252|"~     This study will provide long-term follow-up for patients who have received treatment with~     JCAR015 in a previous clinical trial. In this study, patients will be followed for up to 15~     years after their last dose of JCAR015 for evaluation of delayed adverse events, presence of~     persisting JCAR015 vector sequences, and survival.~   "
57586|NCT02813239|"~     In in vitro fertilization (IVF) cycles, even after adequate triggering, some patients present~     a high rate of immature oocytes retrieved after controlled ovarian stimulation. In vitro~     oocyte maturation is still an experimental technique, with poorer results than conventional~     IVF. For that reason improve in in vivo maturation could have a better impact on reproductive~     outcome.~   "
57587|NCT02813226|"~     In this study 30 men, with advanced metastatic Castration-Resistant Prostate Cancer (CRPC)~     planned to have hormonal treatment, will undergo conventional imaging and functional imaging~     prior to treatment and post treatment to determine if changes in imaging results will be~     prognostic of outcome. Patients will have a clinical follow-up every 3 months post~     randomization for one year and followed for survival at Years 2 and 3.~   "
57588|NCT02813213|"~     This is a double-blind randomized controlled clinical trial, that compares the percentage of~     epithelialization of skin defects using the conventional meshed split thickness skin grafts~     vs skin micro grafts.~      Two techniques will be applied in the same patient. The skin defect will be divided in two~     parts, and with a randomized method each half of this defect will be assigned to one of the~     two techniques.~   "
57589|NCT02813200|"~     Chronic Obstructive Pulmonary Disease (COPD) is the fourth leading cause of death in the~     world and further increase in its prevalence and mortality has been predicted. Currently, the~     main long-term treatments are the long-acting beta-2 agonist, indacaterol, salmeterol and the~     anticholinergic drug, tiotropium and glycopyrronium, used alone or in combination:~        -  long-acting beta-2 agonist with corticosteroid (e.g. salmeterol/fluticasone),~        -  long-acting beta-2 agonist with anticholinergic (e.g. indacatetrol/glycopyrronium).~      These drugs are delivered to the lung using different inhaler devices such as Breezhaler ®,~     Handihaler® and Diskus®.~   "
57590|NCT02813187|"~     This is an observational, longitudinal real world registry of venous leg ulcers created from~     electronic health record data obtained in the course of clinical care. Data from certified~     electronic health records transmit data as part of the requirement to share data with a~     specialty registry under Objective 10 of Meaningful Use of an EHR.~   "
57591|NCT02813174|"~     The primary aim of this study is to assess the relationship between personality style,~     self-compassion and depression during pregnancy, to identify psychological risk factors,~     particularly personality styles, that may contribute to the onset of PPD. Additionally, the~     study will provide support for the effectiveness of Internet-based Compassionate-Mind~     Training (iCMT) as a prevention intervention for Postpartum Depression (PPD) for women in the~     2nd and 3rd trimester of pregnancy. The study will also assess differences along personality~     predictors and depression severity as they relate to intervention outcomes (i.e. depression~     in postpartum and self-compassion) and engagement. The researchers hypothesize that women~     both at high and low risk for PPD will receive benefits from the intervention, however, those~     who endorse more maladaptive personality traits will likely engage and benefit less than~     those who do not endorse these traits.~   "
57592|NCT02813161|"~     This is an observational, longitudinal real world registry of diabetic foot ulcers created~     from electronic health record data obtained in the course of clinical care. Data from~     certified electronic health records transmit data as part of the requirement to share data~     with a specialty registry under Objective 10 of Meaningful Use of an EHR.~   "
57593|NCT02813148|"~     This post-authorization observational safety study determines the characteristics of patients~     prescribed naloxegol at time of first prescription and treatment patterns of naloxegol in~     follow-up in the United Kingdom (UK), Norway, Sweden, and Germany.~   "
57643|NCT02812498|"~     The purpose of this study is to compare the effects on glycemic control of Teleconsultation~     versus standard visit in outpatient clinic for patients affected by type 1 diabetes mellitus.~   "
57594|NCT02813135|"~     The first molecular profiling protocols have been launched in Europe (MOSCATO-01 (Geoerger~     2014), MAPPYACTS, INFORM, iTHER, SM-PAEDS, etc.) determining multiple actionable alterations~     in pediatric recurrent cancers. Increasingly, stratified approaches are being implemented to~     enrich clinical trials of molecularly targeted agents and possibly improve outcomes in~     specific populations i.e. a molecularly enriched/predictive biomarker-driven approach. The~     diversity and heterogeneity of the detected molecular alterations and the low number of~     pediatric patients mandate an adapted, innovative trial design for the attributed treatment~     options in order to satisfy the current unmet medical need.~      This basket trial is designed to cover the targeting of several survival pathways in~     oncogenesis that are currently not adequately employed for pediatric patients in Europe.~   "
57595|NCT02813122|"~     examination of the importance of the use of X-ray in bariatric surgery outcome.~   "
57596|NCT02813109|"~     The true renal function of preterm infants is difficult to evaluate. Serum creatinine (Cr)~     levels in infants are unreliable as a detector of renal function in the first few days of~     life because they may continue to reflect maternal levels. Although few candidates appear to~     be a useful biomarker for kidney injury, scant reference data on these biomarker in preterm~     infants exist, and studies have yielded conflicting results. Therefore, we aimed to determine~     the reliable urinary biomarkers to detect kidney injuries in preterm infants.~   "
57597|NCT02813096|"~     This study is to investigate the efficacy and safety of Folfox4 chemotherapy regimen to~     prevent early recurrence for hepatocellular carcinoma patients with portal vein tumor~     thrombus following curative resection~   "
57598|NCT02813083|"~     This study will help the investigators design a method to detect the disease-causing immune~     cells in patients with rheumatoid arthritis (RA). Such methods are not currently available,~     but if successful, would help scientists to better understand the causes of RA.~   "
57599|NCT02813070|"~     This was a Phase 2, multicenter study to assess the extent and patterns of [18F] flutemetamol~     uptake in the brains of 3 groups of Japanese subjects: healthy volunteers (HV), amnestic mild~     cognitive impairment (aMCI), and probable Alzheimer's disease (pAD), and to assess the~     reproducibility of brain uptake and of image interpretation. Subjects underwent open-label~     intravenous (i.v.) administration of Flutemetamol F 18 Injection and Positron emission~     tomography (PET) imaging of the brain. Blinded visual image reads were performed by 10~     independent board-certified readers (5 Japanese and 5 non-Japanese) with nuclear medicine~     image interpretation experience. The blinded visual assessments were compared with the~     subject's clinical diagnoses, and the agreement between the image interpretations made by the~     2 groups of readers (Japanese and non-Japanese) was determined.~   "
57600|NCT02813057|"~     Comparison of physical activity parameters of the lower extremity muscles in patients who~     received total extraperitoneal repair (TEP) and STOPPA repair.~   "
57601|NCT02813044|"~     A number of studies have compared the effects of total intravenous anesthesia(TIVA) versus~     inhalational anesthesia on perioperative period during transsphenoidal surgery. However, they~     have limitations especially for the phase of recovery after anesthesia: a fragmentary~     assessment. Quality of Recovery 40 (QoR-40) questionnaire was multi-dimensionally designed to~     assess the degree of recovery, specially after anesthesia and surgery. In this study, the~     investigators aim to compare the quality of recovery after inhalational anesthesia and after~     TIVA through QoR-40 questionnaire in patients undergoing transsphenoidal surgery for~     pituitary tumor under general anesthesia.~   "
57602|NCT02813031|"~     Nutritional clinical trial to evaluate the effectiveness of different functional meat~     products on the nutritional status of healthy people~   "
57603|NCT02813018|"~     Management of postoperative pain is critical in the pediatric patients, however, safe and~     effective analgesia for pediatric surgical patients remains a challenge. Preemptive analgesia~     is based on preventing a prolonged change in central nervous system function by blocking~     afferent input before the surgical stimulation may evoke central sensitization and aggravate~     amplification and prolongation of postoperative pain. However, the clinical efficacy of~     preemptive analgesia is still controversial. In this study, the investigators aim to assess~     the impact of preemptive epidural analgesia on postoperative pain in pediatric patients for~     corrective osteotomy of the lower extremities expecting severe postoperative pain.~   "
57604|NCT02813005|"~     Evaluate benefits of High Frequency Jet Ventilation compare to standard ventilation during~     general anesthesia in patient undergoing peri diaphragmatic percutaneous tumor ablation.~      The investigators hypothesis that procedure is shorter and more accurate in High Frequency~     Jet Ventilation group reducing target movement induced by ventilation.~   "
57605|NCT02812992|"~     The hypothesis of the proposed study is that individualized assessment directed treatment~     algorithms identifies elderly patients, who benefit from combined nab-paclitaxel/gemcitabine~     therapy. The project uses a CGA, which includes various tests and scoring systems, to~     stratify patients as GO-GO, SLOW-GO or FRAIL patients. Depending on test results~     patients receive chemotherapy (GO-GO group: nab-paclitaxel/gemcitabine; SLOW-GO group:~     gemcitabine monotherapy) or best supportive care (FRAIL group). After the first cycle of~     chemotherapy (4 weeks) a subsequent CGA and a safety assessment will be performed to assign~     patients to their definite treatment arm. The primary objective is that CGA-stratified~     patients do not decline in their CGA performance in response to chemotherapy measured as a~     loss of five points or less in the Barthel`s ADL (ADL1 vs. ADL2 during core CGA assessment).~   "
57606|NCT02812979|"~     The principal objective is to show noninferiority of nebulized salbutamol through the high~     flow nasal system moistened AIRVO ™ 2 in terms of reversibility of airflow obstruction~     compared to nebulization by the usual method (spray mask).~   "
57607|NCT02812966|"~     Investigators hypothesize in patients presenting with significant peripheral arterial disease~     with clinical indications for treatment with angioplasty, there will be a difference in 12~     month patency between the subjects with Lutonix 035 Drug coated Balloon PTA Catheter and~     IN.PACT Admiral Paclitaxel-Coated PTA Balloon Catheter.~   "
57644|NCT02812472|"~     The purpose of this study was to investigate the effects of the treadmill training with~     functional electric stimulation on sensorimotor cortical reorganization and functional~     improvement in subjects with chronic stroke.~   "
57645|NCT02812459|"~     The purpose of this study is to analyze the effectiveness of electrical stimulation and~     kinesio taping in combination with exercise in People with Chronic Low Back Pain~   "
57608|NCT02812953|"~     A sample of plasma and whole blood will be obtained at 4 time points (pre-procedural, early~     post-procedural, at hospital discharge and during an eventual visite at 3 or 6 months~     post-procedural). Test for platelet reactivity (LTA, light transmittance aggregometry and~     Elisa PRI, Platelet reactivity index), multimeric VWF (von Willebrand factor) and blood level~     of NET: neutrophil extracellular traps(flow cytometry and ELISA) analyses will be performed~     at the time of blood sampling. Aliquots of plasma will be stored and frozen for further~     analyses~   "
57609|NCT02812940|"~     A phase II clinical study to assess the efficacy of short-term everolimus as prophylaxis for~     Graft-versus-Host disease (GvHD) in addition to post-transplantation cyclophosphamide after~     allogeneic hematopoietic stem cell transplantation in patients with haematological~     malignancies~   "
57610|NCT02812927|"~     This study compared two methods of insulin infusion by syringe pumps to assess the impact of~     medical devices on the glycaemic variability in patients under IIT in ICU. The main objective~     of the study was to show the superiority of the infusion system which permitted to dedicate a~     line for the insulin administration on the standard installation in terms of control of~     glycaemic variability.~   "
57611|NCT02812914|"~     Greater efforts are needed to bring affordable, clean stoves and adaptive behavioral~     strategies to the millions of households worldwide that continue to burn solid cooking fuels~     using inefficient stoves. Two of the leading causes of infant mortality, preterm birth and~     pneumonia, are associated with high exposures to household air pollution during pregnancy and~     early infancy. The proposed study will assess the feasibility and acceptability of an~     introduced liquid petroleum gas stove, complemented by two alternative approaches to~     delivering tailored behavioral change interventions, among pregnant women and their neonates.~   "
57612|NCT02812901|"~     This study aims to understand the impact of time-of-the day on human myocardial tolerance to~     ischemia-reperfusion by exploring atrial myocardium biopsied during cardiac surgery. Patients~     scheduled for non-urgent cardiac surgery (coronary artery by-pas graft and/or aortic valve~     replacement) will be assigned to a morning or an afternoon cardiac surgery based on~     randomization. Myocardial biopsies will be explored in ex vivo conditions mimicking~     ischemia-reperfusion.~   "
57613|NCT02812888|"~     Clustering of various metabolic parameters including abdominal obesity, hyperglycaemia, low~     high-density lipoprotein cholesterol, elevated triglycerides and hypertension have been used~     worldwide as metabolic syndrome to predict cardiometabolic risk. Thyroid dysfunction impacts~     on various levels of these components.~      Recent evidence from HepG2 cells indicates that betatrophin, also known as~     TD26/RIFL/lipasin/ANGPTL8/C19orf80, a secreted protein that regulates glucose, lipid~     metabolism, and energy homeostasis, is induced by T3. However, the role of betatrophin in~     hyperthyroid patients is unknown.~      The objective was to study serum betatrophin levels in hyperthyroid patients and the~     association of serum betatrophin levels with hyperthyroidism.~   "
57614|NCT02812875|"~     CA-170 is a rationally designed and orally available, small molecule that directly targets~     the Programmed death-ligands 1 and 2 (PD-L1/PD-L2), and V-domain Ig suppressor of T cell~     activation (VISTA) immune checkpoints and results in activation of T cell proliferation and~     cytokine production. This is a multi-center, open-label, Phase 1 trial of orally administered~     CA-170 in adult patients with advanced solid tumors or lymphomas who have progressed or are~     non-responsive to available therapies and for which no standard therapy exists.~   "
57615|NCT02812862|"~     The aim of this study is to evaluate the pulmonary and cardiac effects of a LABA / LAMA~     combination therapy in patients suffering from both chronic heart failure and chronic~     obstructive pulmonary disease.~      The secondary aim of the study it to assess the safety of the LABA / LAMA combination.~   "
57616|NCT02812849|"~     The purpose of the trial is to determine the accuracy of Cu-64 labelled DOTATATE for~     diagnosing cardiac sarcoidosis using PET/CT or PET/MRI.~   "
57617|NCT02812836|"~     Anorectal 3D manometry (3D HRAM) is the most advanced version of manometric equipment that~     measures pressures along the anal canal in a very detailed manner. It provides complete data~     about pressure profile of anorectum and may indicate impaired defecation dynamics. Balloon~     expulsion test (BET) is a cheap, easy way to diagnose constipation as the result of outlet~     obstruction.~      Our aim is to compare this two methods of diagnosis of dyssynergic defecation and to find the~     correlation between this diagnostic equipment.~   "
57618|NCT02812823|"~     Pressures measured by manometric solid-state catheters may differ according to the type of~     the catheter and specific anatomy and physiology of anorectum.~      The aim of the study is to establish the difference in recordings between 2 types of~     anorectal catheters used in pediatric patients and to validate the most appropriate way to~     diagnose of functional disorders.~   "
57619|NCT02812810|"~     The fight against smoking is a public health priority. Without help, fewer than 5% of des~     smokers are abstinent at 12 months after smoking cessation.~      Despite well-managed attempts at smoking cessation with nicotine substitutes, the rate of~     success at 12 months in patients dependent on nicotine is only 18%. Moreover, other~     therapeutic strategies (acupuncture, hypnosis…) have not proved to be effective.~      The investigators propose a new therapeutic strategy for smoking cessation, which is based on~     associating nicotine substitutes (to reduce physical symptoms of weaning from nicotine) with~     rTMS at 1 Hz to the right DorsoLateral PreFrontal Cortex (DLPFC) for 2 weeks (to diminish~     craving for tobacco). The principal objective is to improve the success rate for smoking~     cessation attempts in patients who are highly dependent on nicotine, and who have failed~     using usual smoking cessation strategies.~   "
57620|NCT02812797|"~     The purpose of this study is to determine whether expressions of adipokines can provide~     prognostic information concerning patients with chronic heart failure.~   "
57646|NCT02812446|"~     The purpose of this study is to identify bacterial and/or clinical features involved in the~     pathogenesis of Staphylococcus aureus implant-associated infections (IAI). Materials &~     methods: In total, 57 IAI S. aureus and 31 nasal carriage (NC) S. aureus isolates were~     studied. Staphylococcus aureus genetic background was obtained by microarray analysis.~     Multilocus sequence typing was performed to determine clonal complexes (CC). Biofilm~     production was investigated by resazurin and crystal violet methods~   "
57770|NCT02810795|"~     The purpose of this study is to determine the diagnostic accuracy of MPICT for the detection~     of hemodynamically relevant coronary stenosis (as determined by invasive FFR) in patients~     with suspected or known CAD clinically referred for invasive angiography.~   "
57621|NCT02812784|"~     Patients with septic shock in the intensive care unit have an elevated risk of developing~     acute kidney injury (AKI). AKI is an independent factor for mortality. Interventions that~     limit the worsening of renal function might have an impact on the mortality rate in these~     patients. Given the absence of validated pharmacological treatments for limiting the~     progression of AKI or for accelerating recovery from AKI, early intervention and the~     restoration of the glomerular filtration rate (GFR) in this context of hemodynamic change~     during the initial phase of septic shock might improve the patients' prognosis. One major~     challenge is therefore how to determine whether or not the AKI is reversible. The~     best-studied biomarkers (NGAL and KIM 1) have little discriminant power in septic patients~     because of their poor specificity or unsuitable kinetics for very early diagnosis. The~     combination of urine assays for tissue inhibitor of metalloproteinase 2 (TIMP2) and~     insulin-like growth factor binding protein 7 (IGFBP7) has shown good diagnostic performance~     for the very early detection of the risk of developing AKI in the following 12 hrs. Urine~     levels of these two markers specifically reflect damage to kidney tubules. Moreover, the~     levels appear to be strongly correlated with the severity of tubule damage. Thus, one can~     reasonably hypothesize that measurement of these markers in the very early stages of septic~     shock might determine the presence and severity of kidney tubule damage. A threshold (yet to~     be defined) would help to differentiate between (i) transient, non-severe injury and (ii)~     injury that is already too severe to be reversible.~   "
57622|NCT02812771|"~     Safety and PK of a once daily topical application of efinaconazole in the treatment of~     pediatric subjects with mild to severe onychomycosis of the toenails.~   "
57623|NCT02812758|"~     Dynamic indices of preload dependence (such as stroke volume variability -SVV , pulse~     pressure variability - PPV and plethysmograph variability index - PVI ) are reportedly~     predictive of the response to vascular filling in sedated, mechanically ventilated patients.~     However, the influence of the sedation depth on these dynamic indices has never been~     evaluated.~   "
57624|NCT02812745|"~     Monitoring the bispectral index (BIS) as a peri-operative hemodynamic tool appears to be~     justified by the agreement between various clinical situations in which BIS monitoring~     appears to be of value: the prognosis in traumatic head injury, the diagnosis of brain death~     , and the diagnosis of amniotic fluid embolism. The current controversy concerning the~     triple low state reinforces the need for an accurate study in this field. Furthermore, the~     recent review by Bidd argues in this sense.~   "
57625|NCT02812732|"~     After completing over 600 interviews with parents, adolescents, and clinicians to determine~     reasons why HPV vaccines are used or not used, the investigators recently piloted a~     communication-based educational intervention with healthcare clinicians to improve~     communication around HPV vaccination. The intervention combined education and quality~     improvement methods using a mechanism called Performance Improvement Continuing Medical~     Education. This type of intervention is attractive to clinicians because they improve their~     cancer prevention practices while fulfilling requirements for maintaining board~     certification. The intervention consists of seven education and feedback sessions along with~     baseline and follow-up chart reviews and facilitated group discussions of clinician and~     practice vaccination rates. The pilot intervention was effective: at the two pilot~     intervention sites, girls were 60% and boys were 15 times more likely to receive HPV~     vaccination than at control sites both during and after the intervention period.~      The goal of the proposed research is to broadly test the intervention's effectiveness in a~     diverse group of pediatric and family medicine practices serving low-income and minority~     patients. First, the investigators will perform a randomized trial in five community health~     centers to determine the effectiveness of the intervention. Second, the investigators will~     examine what made the intervention successful and identify barriers to sustainability with~     the goal of ensuring that the intervention can be successfully replicated in other settings.~     Third, the investigators will explore the effects of the intervention on parent-clinician~     communication by surveying parents and clinicians and observing clinical encounters when~     vaccination is discussed.~      The proposed intervention represents an innovative and scalable model for promoting cancer~     prevention and screening activities by clinicians. Unlike programs that increase~     administrative burdens on busy clinicians, the proposed intervention allows clinicians to~     improve cancer prevention practices while simultaneously fulfilling requirements to maintain~     their board certification and improving the quality of cancer prevention care. It therefore~     has great potential for widespread dissemination.~   "
57626|NCT02812719|"~     The aim of this pilot study is to conduct a controlled comparison of the efficacy and safety~     of a combination peel (glycolic acid and salicylic acid) as compared to glycolic acid peel~     alone in the treatment of melasma. Our primary outcome is objective improvement in~     pigmentation as evaluated using a colorimeter. Our secondary outcomes are subjective~     improvement using the Melasma Area and Severity Index (MASI) and Patient and Physician Global~     assessment, as well as assessment of treatment tolerability and patient satisfaction.~   "
57627|NCT02812706|"~     Primary Objectives:~        -  Phase I: To evaluate safety and tolerability of isatuximab in Japanese patients with~          relapsed and refractory multiple myeloma.~        -  Phase II: To evaluate efficacy of isatuximab at recommended dose and to further evaluate~          the overall response rate (ORR) of isatuximab in Japanese patients with relapsed and~          refractory multiple myeloma.~      Secondary Objectives:~        -  To evaluate the safety including immunogenicity of isatuximab. The severity, frequency~          and incidence of all adverse events will be assessed.~        -  To evaluate the pharmacokinetic (PK) profile of isatuximab in the proposed dosing~          schedule.~        -  To assess the efficacy using International Myeloma Working Group (IMWG) uniform response~          criteria.~        -  To assess the relationship between baseline CD38 receptor density on multiple myeloma~          cells and efficacy.~   "
57628|NCT02812693|"~     This phase I/II trial studies the side effects and how well pembrolizumab and imatinib~     mesylate work in treating patients with melanoma with c-KIT mutation or amplification that~     has spread to nearby tissue or other places in the body. Monoclonal antibodies, such as~     pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Imatinib~     mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Giving pembrolizumab and imatinib mesylate may work better in treating patients with~     melanoma with c-KIT mutation or amplification that has spread to nearby tissue or other~     places in the body.~   "
57629|NCT02812680|"~     Circulating microRNA (circ miRNA) and circulating tumor cell (CTC) levels are hypothesized to~     be associated with response to chemoradiation in patients undergoing treatment for locally~     advanced esophageal adenocarcinoma.~      The goal of this project is to assess the use of circulating microRNA (miRNA) and circulating~     tumour cells (CTC) as biomarkers of cancer and predictive markers for neoadjuvant therapy.~   "
57630|NCT02812667|"~     The purpose of the study is to determine whether plinabulin (also known as BPI-2358) has an~     effect on cancer and body in combination with nivolumab, a standard treatment for metastatic~     squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy.~      Plinabulin inhibits tumor growth by targeting both new and existing blood vessels going to~     the tumor as well as killing tumor cells. Plinabulin is an investigational drug, a drug that~     is not approved for use outside of research studies by regulatory agencies. Up to 38 patients~     will be enrolled.~   "
57632|NCT02812641|"~     Esophageal squamous cell carcinoma (ESCC) is one of the ten leading cancers in Taiwanese~     male. The prognosis is poor with a five-year overall survival rate of 10 to 30 %. Randomized~     clinical trials have demonstrated that trimodality therapy (TMT), consisted of neoadjuvant~     concurrent chemoradiation (CCRT) and radical esophagectomy, improves the overall survival for~     patients with locally advanced disease. Despite of the advancement, the outcome remained~     unsatisfactory with the median progression-free survival around 20 to 25 months and median~     overall survival around 30 months. It is know that the most important prognostic factor is~     whether a pathological complete response can be achieved after neoadjuvant CCRT. However, the~     use of new generation chemotherapeutic agent taxanes and epidermal growth factor inhibitors~     (such as Cetuximab) failed to significantly improve prognosis comparing to the standard~     platinum-fluorouracil (PF) regimen. As a consequence, it is mandatory to develop new~     chemotherapeutic regimen for CCRT.~      In previous prospective studies, investigators used proximal ligation assay technology to~     identify serum VEGF-A in correlation with the pathological response and prognosis for~     patients receiving neoadjuvant CCRT plus radical esophagectomy for locally advanced ESCC.~     Other investigators also showed high VEGF expression correlating to poor outcome. Therefore,~     investigators generate the hypothesis that adding vascular endothelial growth factor (VEGF)~     monoclonal antibody, Bevacizumab, to standard neoadjuvant CCRT may improve outcome for~     patients with ESCC. Meanwhile, several prospective clinical studies have shown the~     feasibility, safety, and activity of adding Bevacizumab to chemotherapy, CCRT, or combined~     modality therapy including surgery, either in head and neck cancer, esophageal cancer, or~     esophagogastric junction adenocarcinoma. However, its efficacy should be further investigated~     in larger prospective trials and little is known about the activity and toxicity of~     Bevacizumab in ESCC due to small number of reported cases. In the present clinical trial,~     investigators plan to investigate whether incorporation of Bevacizumab into standard~     neoadjuvant PF-CCRT will improve treatment response and increase pathological complete~     response rate. Investigators will also evaluate associated biomarkers in relation to~     prognosis. By the present research, investigators expect to develop a new TMT regimen for~     this poor prognostic disease.~   "
57633|NCT02812628|"~     This study is designed to compare the short-term and long-term benefits between conventional~     laparoscopic abdominoperineal resection (APR) and laparoscopic APR with transabdominal~     individualized levator transection (TILT).~   "
57634|NCT02812615|"~     This is a community-based intervention study which will be undertaken at Mirpur, Dhaka,~     Bangladesh. Participants will be recruited from two age groups: a child cohort (age 12 to 18~     months) and an adult cohort (age 18 to 45 years). The child cohort will consist of stunted~     children (length for age Z score, LAZ < -2), children who are at risk of stunting (length for~     age Z score <-1 to -2) and child controls. The adult cohort will consist of malnourished~     adult cases (Body Mass Index <18.5) and adult controls. After screening the participants for~     any organic diseases and application of inclusion/exclusion criteria, they will receive~     nutrition interventions. Participants eligible for study will be tested for potential bio~     markers of environmental enteropathy (stool, urine and serum) once before and once after the~     nutritional intervention. Participants who will fail to respond to nutritional therapy~     (measured by anthropometric assessment) will become candidates for upper gastrointestinal~     endoscopy with biopsy. The study will include duodenal biopsies from a control group of~     children from University of Virginia Hospital in Charlottesville, Virginia who will undergo~     upper GI endoscopy as part of their clinical care as per the standard clinical protocol~     followed at the hospital. Adult controls (BMI > 18.5) for endoscopy will be collected from~     international centre for diarrhoeal disease research,Bangladesh staff clinic, Dhaka Medical~     College and Hospital (DMCH), Dhaka and Bangabandhu Sheikh Mujib Medical University (BSMMU),~     Dhaka.~   "
57635|NCT02812602|"~     Lidocaine patch is a safe and effective topical anesthetic agent for removal of metal staples~     after total knee replacement~   "
57636|NCT02812589|"~     The breast MRI is used in the preoperative scenario to evaluate the extension of a newly~     diagnosed breast cancer and to screen the contralateral breast. The scan consists of a series~     of images taken after the use of intravascular contrast media that may detect areas of~     enhancement that look malignant, but are actually benign tissue, producing a false positive~     result. The investigators aim to evaluate a novel MRI sequence of images that does not use~     contrast, diffusion tensor imaging (DTI). Addition of DTI sequence does not add significantly~     to the time of standard breast MRI exam. This novel technique provides improved detection of~     tissue microstructure and is able to differentiate malignant from benign tumor. Hence, the~     investigators hypothesize that DTI may decrease the false positive rate when compared with~     standard dynamic contrast-enhanced (DCE) MRI.~   "
57637|NCT02812576|"~     Data on neonatal GBS disease are very limited in China. Acceptance and implementation of~     prevention measures such as antibiotics prevention or vaccination against GBS disease would~     require robust data. This study as the first national, multicenter study to investigate the~     epidemiology of GBS disease in China, and the resistance surveillance of GBS isolates, to~     appraise the necessity of appropriate interventions.~   "
57638|NCT02812563|"~     The principal objective of this study is to evaluate the frequency of KC inside family of~     patients with confirmed KC.~      It's a familial, epidemiological, prospective, single-center study.~   "
57639|NCT02812550|"~     The purpose of this study is to compare the adenoma detection rates of full-spectrum~     endoscopy versus standard forward-viewing colonoscopy in colorectal cancer screening~     programme.~   "
57640|NCT02812537|"~     Conduct disorders are defined as repetitive and persistent pattern of behavior in which the~     basic rights of others or major age-appropriate norms are violated. So defined, these~     disorders are at the crossroads of psychiatry, social field and justice. Conduct disorder~     management is a public health issue and a societal question. Conduct disorders affect 5 to 9%~     of 15-year old boys.~      Care management of children and adolescents admitted for disruptive behaviors in emergency~     rooms is an issue. No consensus or official recommendation exists. However, use of emergency~     care in this context is increasing in most western countries and it exposes to several risks~     (inappropriate use of hospitalizations, social rupture, ignorance of comorbidities and~     suicide risk). The Trajectories project is designed to describe children and adolescents with~     disruptive behaviors, their care management and to follow their life trajectory and~     psychiatric evolution after admission to emergency rooms. Better understanding this~     population will improve their medical and social care management, thereby giving~     professionals the right tools.~      The main objective of this project is to implement a multidisciplinary and integrative~     research combining clinical considerations and social sciences to determine the trajectory~     of this population.~   "
57641|NCT02812524|"~     This study is for patients with squamous cell carcinoma of the head and neck (SCCHN). This~     study will test the feasibility of the administration of intratumoral injections of~     ipilimumab prior to surgical resection, and the immune system response to treatment.~   "
57642|NCT02812511|"~     The objective is to collect skin biopsies rom patients with Costello syndrome to analyze the~     molecular mechanisms responsible for this syndrome caused by a mutation in the HRAS gene and~     the effects of this mutation on energy metabolism and mitochondrial physiology.~   "
57647|NCT02812433|"~     Despite improvements in neonatal care, birth asphyxia in term newborns remains a serious~     condition causing significant mortality and long-term morbidity, including cerebral palsy and~     mental retardation. Currently, no treatment exists to repair brain injuries secondary to~     neonatal asphyxia. The only available treatment for this condition is hypothermia that may~     prevent but not repair the development of brain injury. The success of this therapy is~     limited.~      Sildenafil already is used with some newborns for other purposes (i.e., persistent pulmonary~     hypertension), but, surprisingly, its effect on the newborn brain has never been studied~     systematically. The findings of the investigators in the rat model of term neonatal~     encephalopathy demonstrated that the administration of sildenafil following asphyxia promotes~     brain injury recovery. Thus, the investigators hypothesize that sildenafil may improve~     neurodevelopmental outcome in term asphyxiated newborns, in whom hypothermia treatment has~     failed to prevent the development of brain injury.~   "
57648|NCT02812420|"~     The goal of this clinical research study is to learn if the combination of durvalumab and~     tremelimumab is safe and tolerable when given to patients with bladder cancer before surgery~     to remove the bladder.~      This is an investigational study. Tremelimumab and durvalumab are not FDA or commercially~     available for the treatment of bladder cancer. The use of these drugs are considered~     investigational.~      Up to 35 participants will be enrolled in this study. All will take part at MD Anderson.~   "
57649|NCT02812407|"~     Does baseline impedance measured during the landmark phase of esophageal High resolution~     impedance manometry HRIM correlates with direct mucosal impedance measurement and~     discriminates GERD from non GERD patients?~   "
57650|NCT02812394|"~     This study will be an open-label, randomized, three-period cross-over pharmacokinetic~     evaluation of CVT-301 compared with the Reference Listed Drug (RLD), orally administered~     carbidopa/levodopa, in healthy volunteers.~   "
57651|NCT02812381|"~     The suture of the supraspinatus tendon is a common surgery that requires physical therapy for~     back pain and functional impairment to such surgery. Kinesiotaping technique (KT) is being~     used to treat myofascial trigger points that appear after surgery and for the treatment of~     physiotherapy in the supraspinatus muscle and deltoid.~      To evaluate the effectiveness of KT technique over the technique of Jones~     (Straincounterstrain or SCS) in patients undergoing suture the tendon of the supraspinatus~     muscle.~   "
57652|NCT02812368|"~     Sleep disturbance has been reported in 44-86% of children with autism spectrum disorder (ASD)~     and is the source of considerable stress for the affected individual and family. Sleep plays~     a role in development and learning processes; thus, the appropriate treatment of sleep~     disturbance is paramount to optimal outcomes. The empirical base for treatments to address~     sleep in ASD is sparse, despite wide use of pharmacologic agents such as clonidine (CLN) to~     target sleep disturbance. A randomized, controlled pilot investigation of CLN for sleep~     disturbance in children with ASD will allow investigators to evaluate the feasibility of~     conducting a much larger multisite trial to address the general lack of systematic data~     available to guide practitioners. Subjects will be 16 children, ages 6-14 years, inclusive,~     with sleep disturbance and ASD. This randomized double-blind, placebo-controlled (PBO),~     parallel groups study will test the efficacy of CLN following a brief sleep hygiene~     intervention. Outcome measures include: informant completed sleep questionnaires, daytime~     behavior questionnaires, and actigraphy. Biomarkers for medication response will include~     galvanic skin response and skin temperature. Side effects will be monitored throughout the~     study.~   "
57653|NCT02812355|"~     The RATIO Study is a multicenter, nationwide, randomized, controlled, single blinded,~     unfunded trial of n. 900 patients undergoing multivessel OPCAB (≥2 grafts). This study is~     designed to test in patients undergoing off-pump coronary artery bypass surgery the~     hypothesis that full (high dose, 300 U/kg) and half (low dose,150 U/kg) heparinization are~     not different in terms of thrombotic complications and major perioperative bleeding events~     (null hypothesis).~   "
57654|NCT02812342|"~     The purpose of the study is to investigate the use of topical tofacitinib to promote hair~     regrowth in patients with alopecia areata, alopecia totalis, and alopecia universalis.~   "
57655|NCT02812329|"~     This study aims to minimize risk of human immunodeficiency virus (HIV) in adolescent boys and~     girls, ages 15-16, by promoting HIV testing and counseling (HTC) through the use of an~     interactive videogame. With input from focus groups of adolescents, the investigators will~     adapt an HIV prevention videogame, PlayForward: Elm City Stories, for adolescents ages 15-16~     . The investigators will then pilot test the videogame in 30 adolescents to assess the~     acceptability and feasibility of the videogame. They will also assess whether the videogame~     increased the participants' intentions to obtain HTC, whether they actually obtained HTC, and~     whether the videogame increased knowledge of HIV.~   "
57656|NCT02812316|"~     Study to evaluate the safety and efficacy of HI-BRITE large diameter rigid gas permeable~     contact lens (hexafocon b) test when worn on a daily wear basis in the correction of~     myopia/hyperopia/astigmatism/presbyopia/ and irregular cornea.~   "
57657|NCT02812303|"~     A pilot program was created by the network's primary care leadership team at Massachusetts~     General Hospital. A population health management program was implemented for chronic disease~     management. The investigators evaluated quality of care process and outcome measures over the~     first six months of the program and compared practices assigned a central population health~     coordinator to those not assigned this support.~   "
57658|NCT02812290|"~     Objective: To evaluate the potential impact of molecular phenotyping of transbronchial~     biopsies in lung transplant recipients with allograft dysfunction, and the potential for~     developing a safer endobronchial mucosal biopsy format.~   "
57659|NCT02812277|"~     This is a single centre, observational and retrospective clinical study. The study group was~     about all HR positive postmenopausal breast cancer patients who were hospitalized between~     January, 2008 and October, 2010, and ever accepted AI therapy with the completed follow-up~     data.~   "
57660|NCT02812264|"~     This study will test the effectiveness of a mobile application that uses an Application~     Program Interface (API) to distribute evidence-based weight loss interventions. Half of the~     participants will receive this API-based application, and the other half of the participants~     will use a non API-based application.~   "
58448|NCT02801864|"~     The purpose of this study is to determine if transcranial direct current stimulation (tDCS)~     in conjunction with intensive speech therapy will improve sentence production and word~     retrieval in individuals with chronic post stroke aphasia.~   "
57661|NCT02812251|"~     The purpose of this study is to investigate the safety and tolerability of JNJ-61393215~     versus placebo after single oral dose administration under fasted (ascending dose levels) and~     fed condition, to characterize the pharmacokinetics of JNJ-61393125 in plasma, cerebrospinal~     fluid (CSF) and urine after single oral dose administration and to investigate the effect of~     food (high fat/high calorie) on the pharmacokinetics of JNJ-61393215 following single oral~     dose administration.~   "
57662|NCT02812238|"~     Background:~      The immune system controls how the body responds to infection or injury. Researchers want to~     see what effect a dietary supplement called nicotinamide riboside (NR) has on the immune~     system. A study showed that fasting has a good effect on immune cell health in healthy~     people. And when immune cells were exposed to NR they had a similar positive response as with~     fasting. Researchers want to see if healthy people have the same effects from NR and fasting,~     and if those effects last.~      Objectives:~      To see if taking nicotinamide riboside will have the same healthy immune system effects as~     fasting. To see if these good effects continue even after eating again.~      Eligibility:~      Healthy volunteers ages 18 39~      Design:~      Participants will be screened with medical history, physical exam, and blood tests. Women~     will have a urine pregnancy test.~      Participants will take 4 pills of either NR or a placebo once a day for 1 week.~      On day 6, they will not eat or drink anything.~      On day 7, they will have a study visit to give a blood sample before and after eating a meal~     at the clinic.~      They will also give a urine sample.~      Participants will stop taking the pills for 1 2 weeks.~      Participants will take either NR or a placebo once a day for 1 week.~      They will repeat day 6 and day 7 of the first week.~      Participants will get NR once and placebo once, but will not know which they are taking.~   "
57663|NCT02812225|"~     The multi-center study evaluates BrainPulse recordings from subjects with a suspected or~     confirmed concussion to improve a concussion detection algorithm. Subjects may also consent~     for a 5 additional follow-ups over a 21-day period to compare the progression of change in~     their BrainPulse recordings.~   "
57664|NCT02812212|"~     Cortical transit time on diuretic renogram as an early marker of significant obstruction in~     antenatally detected uretero-pelvic junction syndrome~   "
57665|NCT02812199|"~     This is a randomized controlled first in man study. Study purpose is to assess safety and~     efficacy of Composite Removable Stent Composite Stent implantation post-endoscopic sinus~     surgery in terms of:~        -  Sinus tissue adhesions~        -  Middle turbinate lateralization into nasal septum i.e. postoperative opening reduction~        -  Inflammation~   "
57666|NCT02812186|"~     This is a two period cross-over study randomizing patients undergoing laparoscopic surgery~     into 2 different groups: group 1 in which patients receive deep neuromuscular blockade in~     the beginning portion of their laparoscopic surgery followed by a period of moderate~     blockade and, group 2 in which patients receive moderate neuromuscular blockade in the~     beginning portion of their laparoscopic surgery followed by a period of deep blockade. The~     deep neuromuscular block is defined as post tetanic count of 1 to 2 and the moderate~     neuromuscular block is defined as 1-2 twitches. In all patients, sugammadex is used to~     reverse the block at the end of surgery in order to obtain optimal extubating conditions.~   "
57667|NCT02812173|"~     The purpose of the study is to determine, whether the postoperative quality of micturition~     and continence can be improved depending on the urinary drainage catheter and retention after~     robot assisted radical prostatectomy. Another finding could be the study of the pain~     assessment of the patient, as well as the pain medication at the various derivatives. Further~     check whether infections and the presence of bacteriuria can be reduced or avoided by the~     form of urinary drainage.~   "
57668|NCT02812147|"~     This research study is being done to determine whether treatment with L-~     Dihydroxyphenylserine (L-DOPS) versus placebo (an inactive substance that looks like study~     drug) in addition to other Parkinson Disease (PD) drugs will improve balance, walking, and~     reduce risk of falls and/or severity of falls in PD subjects. The study is also being done to~     determine the effectiveness, safety, and tolerability of L-DOPS, and whether it will decrease~     Freezing of Gait (FOG), improve apathy (generalized disinterest) or show a relationship~     between apathy and slowed movement and fall risk.~   "
57669|NCT02812134|"~     Fibroblast growth factor 23 (FGF23) is a recently discovered phosphaturic hormone produced by~     osteocytes. It is involved in phosphate-calcium metabolism (via its phosphaturic action and~     inhibition of 1,25-OH vitamin D).~      There are no published studies on the role of FGF23 in undernourished anorexic adolescents~     taking oral phosphorus supplements.~   "
57670|NCT02812121|"~     Hepatitis B virus (HBV)-related acute-on-chronic liver failure (ACLF) is a severe disease~     with high mortality. Our previous study have demonstrated that peripheral infusion of bone~     marrow-derived mesenchymal stromal cells (MSCs) weekly for 4 times is safe and improves 24~     weeks survival rate of ACLF patients. In this study, we intend to assess the safety and~     efficacy of umbilical cord blood derived MSCs for HBV-related ACLF patients.~   "
57671|NCT02812108|"~     This study was designed to collect a large series of patients with aneurysms treated~     endovascularly to analyze hemodynamic factors that affect aneurysm recanalization.~   "
57672|NCT02812095|"~     Refeeding is an extracorporeal stool transport from the proximal stoma end to the distal end~     of stoma. Refeeding may be beneficial in preventing malabsorption, electrolyte imbalance,~     cholestasis and atrophy of the distal intestine. Investigators are focused on evaluating the~     efficacy and safety of the practice of refeeding in preterm infants with enterostomy.~     Clinical data including weight gain, total parenteral nutrition (TPN) usage, and other~     laboratory findings will be collected. Serial citrulline levels during refeeding procedure~     and pathologic specimens of bowel (at the time of stoma closure) will be collected for~     evaluating bowel adaptation.~   "
57673|NCT02812082|"~     The purpose of this study is to develop an interactive web-based patient education program to~     help educate patients about the increased risk of MS and its cardiac risk factors following~     allo-SCT and to inform and motivate patients how to make lifestyle changes. This program will~     be used in addition to counseling at participants clinic visits. The investigators are not~     changing the recommendations for prevention and management of these conditions, but rather~     are trying to improve the way they provide this education to patients.~   "
65572|NCT02708706|"~     This study was conducted to compare the efficacy of hydrodilatation with hyaluronic acid~     under ultrasonographic guidance plus physical therapy (PT) with that of PT alone for treating~     adhesive capsulitis.~   "
57674|NCT02812069|"~     Hypothermia during surgery and in the postoperative period is associated with adverse~     outcomes including impaired drug metabolism, cardiac morbidity, shivering, impaired immune~     function, coagulopathy, and increased use of hospital resources. Several clinical studies~     have demonstrated that maintenance of normothermia during the perioperative period~     significantly reduces morbidity.~      Mercury Biomed has developed a patient-warming system, WarmSmart, that potentially transfers~     adequate heat through hands and feet based on the physiological principle of peripheral~     arterio-venous shunt vaso-dilation. The technology works as a two-step process by selective~     thermal stimulation along the spinal cord to up-regulate blood flow to arterio-venous shunts~     and triggering arterio-venous shunt vasodilation and by applying circulating water heat~     exchangers to the palmar and plantar glabrous skin to warm highly perfused shunts in that~     area.~      General anesthesia reduces the vasoconstriction threshold (triggering core temperature) by~     1-2°C, thus promoting arteriovenous shunt dilation. It remains unknown, though, whether~     cervical spine warming further augments arterio-venous shunt dilation during general~     anesthesia. If spine heating proves unnecessary under anesthesia, Mercury Biomed's WarmSmart~     warming could be simpler and less expensive. Investigators therefore propose to test the~     hypothesis that cutaneous heating near the cervical spine does not further augment~     arterio-venous flow in fingers during general anesthesia.~      Investigators propose to enroll ten patients. The patients will be pre-warmed and warmed~     intraoperatively with forced-air to maintain a core temperature near 36°C.~      A ThermaZone® Device capable of heating the cervical spine area will be positioned behind the~     patient's neck upon arrival in the operating rooms. Additionally a forced-air warmer will be~     positioned appropriately and activated as soon as practical, usually after prepping and~     draping. Ambient temperature will be maintained near 20°C.~      After about one hour of anesthesia when temperature and other factors are stable,~     investigators will start a 30-minute observation period. Thereafter investigators will~     activate the cervical spine warming system for 30 minutes (warming measurement period) and~     thereafter have a 30 minutes control period again.~      Measurements will be recorded such as mean-skin temperature, distal esophageal temperature,~     MAC fraction, mean-arterial pressure and finger blood flow.~   "
57675|NCT02812056|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of alisertib and TAK-228 that can be given to participants with advanced solid~     tumors that are associated with HPV. Researchers also want to learn if the study drug~     combination can help to control advanced solid tumors.~   "
57676|NCT02812043|"~     This study aims to compare the efficacy and safety of amorolfine, long-pulsed Nd:YAG laser~     and the combination between amorolfine and long-pulsed Nd:YAG in treating the~     non-dermatophyte and mixed-infection onychomycosis.~   "
57677|NCT02812030|"~     Diabetic retinopathy remains the leading cause of blindness in patients of working age in the~     Western World, and there is a global epidemic of diabetes. The recommended treatment for~     diabetic retinopathy involves injection of anti-vascular endothelial growth factor~     (anti-VEGF) into the eye. Based on two recent clinical trials taking place in the United~     States, Europe, Japan, and Australia, NICE issued guidance in July 2015 recommending that~     aflibercept (a particular type of anti-VEGF treatment) should be available on the NHS for~     patients in whom the central retina of the eye is at least 400 micrometres thick before~     treatment.~      Real-world data can differ significantly from clinical trial data, and it is therefore very~     important to evaluate the impact of aflibercept in a real world setting, particularly with~     respect to systemic control, as patients with poor systemic control were excluded from the~     clinical trials. This study aims to demonstrate the efficacy of aflibercept in a real-world~     setting, and how this compares to the clinical trial setting.~   "
57678|NCT02812017|"~     This comparative study of will evaluate the effectiveness of promoting critical language and~     cognitive development in infants of low-SES English- and Spanish-speaking parents. TMW-WB~     will target infants zero to six months and their parents during routine Well Baby pediatric~     visits at one week, one month, two months, four months, six months, nine months, twelve~     months,and a final twenty-four month follow-up.~   "
57679|NCT02812004|"~     The Ultra Q Reflex® (Ellex) constitutes the only Nd:YAG laser approved for the treatment of~     vitreous floaters. No randomized controlled clinical trial has been carried out to this day~     in order to investigate its superiority over sham treatment.~      In the present study, 60 eyes will be randomized and blinded into 2 groups, one receiving up~     to two sessions of laser vitreolysis the other scheduled for two sessions of sham treatment.~     After a maximum of two (sham) treatment sessions (1 per month), patients' utility value score~     and BCVA will be re-assessed. A follow-up period of 12 months (with visits at month 1, 6 and~     12 post-treatment) will ensue the treatment phase to register any late adverse events that~     may be associated with laser vitreolysis.~      As vitrectomy constitutes a highly invasive procedure, which must therefore be restricted to~     severe cases only, laser vitreolysis may present a valuable treatment option for patients~     with moderate vitreous floaters that are not eligible for vitrectomy.~   "
57680|NCT02811991|"~     Paracetamol,a classical analgesic agent,constitutes an essential component of multi-modal~     analgesia. This medication is generally safe, well tolerated and effective within recommended~     daily dose.The purpose of the study is to evaluate the efficacy and safety of Paracetamol~     Injection as adjuvant to morphine-based post-operative analgesia, as well as to explore the~     reasonable dosage of paracetamol among Chinese population under above-mentioned circumstance.~   "
57681|NCT02811978|"~     The purpose of this phase 3 study is to determine if subcutaneous velcade is non-inferior to~     intravenous velcade when administered in combination with low-dose dexamethasone in chinese~     refractory or relapsed multiple myeloma (r/rMM) patients. The study will assess the overall~     response rate after 4 cycles of velcade and dexamethasone administration.~   "
57682|NCT02811965|"~     Prevention of heel pressure ulceration is a major clinical concern. Clinical research has~     shown that heel-offloading devices are effective at preventing heel ulceration when compared~     to no offloading or sub-optimal offloading methods (i.e. use of a hospital pillow to offload~     the heel). As a result, a plethora of heel-offloading devices have been developed that~     utilize different designs and materials to offload the heel. Despite the availability of~     these devices, some healthcare facilities still employ no heel offloading or utilize~     sub-optimal heel offloading strategies. It is also difficult for clinicians to compare the~     effectiveness of different heel offloading device without conducting extensive clinical~     evaluations. Pressure mapping of the pressure experienced by the heel while offloaded offers~     a potential method to assess the effectiveness of different heel offloading strategies.~      The primary hypothesis of this study is that the three tested heel offloading devices will~     significantly decrease the heel contact forces compared to no offloading and sub-optimal heel~     offloading conditions. The secondary objective is to quantify differences in heel contact~     forces experienced by the heel when placed in each heel offloading device to demonstrate the~     utility of pressure mapping as a tool to evaluate the effectiveness of different heel~     offloading devices.~      The study will recruit 21 healthy volunteers as research subjects with 7 having a normal BMI,~     7 having an overweight BMI, and 7 having an obese BMI. Pressure mapping will be conducted on~     each research subject for seven randomly applied conditions while the patient lies~     comfortably in a hospital bed. The seven conditions include no heel offloading, 3 sub-optimal~     offloading conditions, and offloading in 3 different heel-offloading devices. Pressure~     measurements corresponding to the heel will be used to determine the average peak pressure~     contact force for each research subject in each condition.~   "
57683|NCT02811952|"~     In many of urothelial carcinoma patients, one does not find common risk factors such as~     smoking. The medical center is located in an industrial city with known air and water~     pollution. The investigators decided to check the presence of nano particles and traces of~     metals in urinary samples of patients known and suspected for urothelial carcinoma and~     compare the results to both cystoscopic and cytological findings. The patients will fill a~     validated epidemiological respiratory disease survey and the results will be compared to a~     control group.~   "
57685|NCT02811926|"~     The purpose of this study is to use routinely-collected health data from registers to examine~     the incidence of parastomal bulging (PB) at different time points in the first year after~     surgery for ileostomy or colostomy. Additionally, the purpose is to investigate risk factors~     for development of PB.~   "
57686|NCT02811913|"~     Stroke affects over 795,000 Americans every year and has an enormous impact on the well-being~     of American Veterans with 6,000 new stroke admissions every year. Many of these stroke~     survivors are living with disabilities that limit their everyday function. One of the major~     consequences of stroke is loss of sensation which manifests as inability to perceive touch,~     temperature, pain or limb movement. Lack of sensation hinders full functional recovery.~     Current treatments for sensory loss produce only limited improvements and do not achieve full~     recovery. Therefore, it is critical to develop new therapies to re-train sensory function.~     The investigators propose to evaluate a novel non-invasive brain stimulation treatment called~     repetitive Transcranial Magnetic Stimulation (rTMS). The effects of this technique on motor~     deficits following stroke have been studied, however rTMS for the treatment of sensory loss~     has not been examined to date. The investigators' study will examine for the first time if~     rTMS of a sensory brain region can improve sensory function in chronic stroke survivors.~   "
57687|NCT02811900|"~     A prospective bariatric database was carried out in the Department of Digestive and Endocrine~     Surgery at the University Hospital of Strasbourg, France, starting in January 1996. All~     potential candidates for obesity surgery were prospectively registered in the database.~     Patients were informed by the bariatric surgeon of the prospective database, and of the~     possibility of utilizing personal data for research purpose after anonymization.~      A case-control study was performed, to compare the quality of life (QoL) of patients treated~     for internal hernia (IH group) with the QoL of patients with an uncomplicated course after~     Roux en Y gastric bypass (Uncomplicated RYGB group).~   "
57688|NCT02811887|"~     To investigate whether simple reminders about healthy lifestyle sent via mobile phone text~     messages can improve the liver cirrhosis severity and prognosis (as assessed by the MELD~     score supported by the Child-Pugh score) among patients with liver cirrhosis that have been~     through a 12-week supervised and facility-based physical exercise training program and~     in-patient rehabilitation.~   "
57689|NCT02811874|"~     The aim of this study is to evaluate the effect of a diabetes education program delivered to~     CHW in improving the metabolic control of patients with type 2 DM.~      The study is a randomized controlled trial conducted in a primary care unit. Eight CHW,~     providing care for 118 patients, are randomized in two groups to receive a one-month diabetes~     education program (intervention group, patients n= 62) or an education course in other health~     issues (control group, patients n= 56).~   "
57690|NCT02811861|"~     This is a multicenter, randomized, open-label, Phase 3 study to compare the efficacy and~     safety of lenvatinib in combination with everolimus (Arm A) or pembrolizumab (Arm B) versus~     sunitinib (Arm C) as first-line treatment in participants with advanced renal cell carcinoma.~   "
57691|NCT02811848|"~     The purpose of this study is to develop and pilot test recruitment methods for a future study~     of prevention of sexually transmitted infections (STI), including the human immunodeficiency~     virus (HIV), among Black adolescent boys through sexual health education by their fathers.~   "
57692|NCT02811835|"~     Short-term (1-year) results of renal transplantation are now excellent (over 95%). Long-term~     (10-year and longer) results are, however, still disappointing. Where most research has~     focused on immunosuppression and infections, the investigators hypothesize that due to poor~     homeostatic capacity and necessary use of immunosuppressive and other drugs, renal transplant~     recipients are much more susceptible to poor dietary habits and exposure to potentially toxic~     contaminants than people of the general population, and that this contributes to accelerated~     function loss of the graft and excess risk of premature mortality, both contributing to poor~     long-term results. This study is a biobank and cohort study which investigates this~     hypothesis.~   "
57693|NCT02811822|"~     This study will evaluate GMI-1271, a specific E-selectin antagonist, in multiple myeloma as~     adjunct to standard of care chemotherapy used to treat this disease.~   "
57694|NCT02811809|"~     This study is open to men who have biochemical recurrence (BCR, increased PSA) following~     local treatment of their prostate cancer. Androgen deprivation therapy (ADT) is a standard~     treatment option, but is only effective for 16-24 months and has a number of side effects~     that impact quality of life. These side effects may include fatigue, hot flushing, loss of~     sex drive, brain fog, decreased bone mineral density, loss of muscle mass, mild anemia (low~     levels of red blood cells that can make people feel tired and weak), diabetes (low blood~     sugar), heart disease, metabolic syndromes (sometimes called pre-diabetes and includes~     obesity, increased blood pressure, high levels of cholesterol and triglycerides in blood),~     and risk of fractures. An alternative to continuous ADT is intermittent administration, where~     patients are given breaks from ADT to let their testosterone levels return to baseline.~     There are a number of potential benefits to intermittent hormone therapy (IHT): (1) longer~     time to the development of resistance; (2) improved patient quality of life owing to recovery~     from adverse effects, particularly sexual function; and (3) substantial cost savings owing to~     less time spent receiving medication. Leuprolide is the name of the ADT / IHT drug.~      Apalutamide is an investigational drug, which means it has not been approved by the Food and~     Drug Administration (FDA). It is an antitumor drug, taken by mouth. The purpose of this study~     is to determine the ability of Apalutamide to extend the time between the first two~     injections of leuprolide and improve quality of life. This study will also look at the safety~     of Apalutamide and the effects that Apalutamide has on prostate cancer.~      Men will be randomized (like flipping a coin) to receive:~        -  Group A: Leuprolide + Apalutamide or~        -  Group B: Leuprolide only (until second leuprolide injection), then leuprolide +~          Apalutamide 45 men will be in Group A and 21 men will be in Group B. Leuprolide is given~          as an intramuscular shot that lasts for 3 months intermittently and Apalutamide is taken~          by mouth (4 tablets) daily. Each cycle is 4 weeks long.~      Intermittent treatment with Apalutamide + leuprolide will continue until continuous~     leuprolide is needed to maintain undetectable PSA levels (i.e., PSA levels rise above~     undetectable level unless leuprolide is given without pause, every 3 months).~   "
57695|NCT02811796|"~     The investigators will collect prospectively baseline, procedural and follow-up data of all~     patients receiving successful percutaneous coronary intervention (PCI) and stent~     implantation. Angio-based flow fractional reserve (quantitative flow ratio, QFR, Medis~     medical imaging systems Leiden, The Netherlands) will be estimated in all patients.~     Especially, the investigators at the end of the procedure (this is defined according~     operator's judgement) will record 2 orthogonal angiograms (as suggested by QFR instructions)~     at 15 frames/second and the same 2 orthogonal angiograms at 30 frames/second. An independent~     corelab (blinded to procedural data and clinical outcome) will estimate QFR value (one with~     the angiograms at 15 frames and one with those at 30 frames~   "
65573|NCT02708693|"~     To compare the effectiveness of ultrasound guided-steroid injection plus splinting to that of~     steroid injection alone using clinical and electrophysiological parameters in patients with~     carpal tunnel syndrome~   "
57696|NCT02811783|"~     This multi-center, double-blind, vehicle-controlled, randomized crossover design study will~     evaluate the safety and efficacy of topically applied naloxone lotion, 0.5%, for the~     treatment of pruritus in patients with the mycosis fungoides (MF) or Sézary syndrome (SS)~     Forms of Cutaneous T-cell Lymphoma (CTCL). This study will also determine if there is~     systemic absorption of the drug in a subset of subjects and if so, describe the range and~     mean plasma levels reached after two weeks of three time daily (TID) dosing.~      Funding Source - FDA OOPD~   "
57697|NCT02811770|"~     Henoch-Schönlein (HS) purpura is a common cause of renal glomerular injury in children. This~     condition is responsible for 10-15% of glomerulonephritis in children. The outcome is~     generally favorable, but up to 5% of patients develop kidney failure. The outcome of patients~     with kidney biopsy is less favorable with 7-50% of them progressing to chronic renal failure.~      Prevalence of HS is difficult to determine from literature. Annual incidence is estimated at~     6.1 / 100,000 children in the Netherlands and up to 20.4 / 100 000 children in the United~     Kingdom. The proportion of children with HS who develop renal disease is difficult to~     determine because the numbers reported in the literature are variable and depend greatly on~     the type of the reporting center, whether or not specialized in pediatric nephrology. Thus~     the proportion of renal disease varies from 20% to 100% of children with a HS.~      The treatment of HS nephropathy (HSN) usually depends on the severity of histological lesions~     but histological classification is discussed and there is currently no consensus. Randomized~     studies are scarce and often do not allow to draw clear conclusions. A meta-analysis~     suggested a positive effect of corticosteroids on renal prognosis of severe forms but in this~     study the definition of renal disease was very heterogeneous. The only classification of the~     HSN recognized is from the International Study Group of Kidney Disease in Childhood (ISKDC)~     which is the following: grade I: minimal glomerula abnormalities, grade II: pure~     proliferation, grade III: crescents/ segmental lesions <50%,grade IV: crescents/ segmental~     lesions 50 to 75%, grade V: crescents/ segmental lesions > 75%, grade VI:~     pseudomesangiocapillary. However, this classification is questioned because it ignores other~     significant histological lesions such as interstitial fibrosis, tubular lesions, glomerular~     and interstitial inflammation, the appearance of crescents (segmental or totally encompassing~     the glomerulus, fibrous or cellular), segmental sclerosis, fibrosis and arteriolar appearance~     in immunofluorescence.~      There is currently no consensus on the criteria indicating the initiation of corticosteroid~     therapy whether oral or intra venous bolus. Some patients with severe clinical and / or~     histological initial presentation can evolve to remission spontaneously while others who have~     more moderate initial symptoms will evolve later to kidney failure. The management is~     therefore heterogeneous. In France, some centers perform a kidney biopsy almost always before~     starting treatment (or in the days following the start of treatment), while in other~     centers's treatment decision is based on the biology resulting from the glomerular disease,~     kidney biopsy being performed possibly in a second time in case of failure of the initial~     treatment.~      Principal objective of the study: assessment of the interest for the long term outcome of~     performing early a kidney biopsy (before the establishment of treatment or within 15 days~     after the start of treatment) in children with HSN compare to kidney biopsy performed later~     (depending on the response to initial therapy) or not performed.~      Secondary objective: assessment of the impact of early kidney biopsy (before the~     establishment of treatment or within of 15 days after the start of treatment) on the initial~     treatment HSN : does it modify or not the treatment started right before it (decided on~     clinical and biological criteria).~   "
57698|NCT02811757|"~     Degenerative changes of the long head of the biceps brachii (LHB) are frequent and often~     associated with cuff tendinopathy. The function of the LHB in the shoulder is still~     controversial and uncertain, whereas its function in the elbow is certain. The biceps brachii~     is a flexor of the elbow and supinator of the forearm. Suppression of the pathologic long~     head of the biceps permits pain relief and is very reliable in the literature. Two options~     are available for the remaining tendon : simple tenotomy or tenodesis which consists to~     reattach the tendon to the humerus. Our hypothesis is that there is no difference in strength~     or endurance of the biceps brachii after tenotomy or tenodesis of the LHB. The aim of this~     study was to compare the strength and the endurance of the biceps brachii during supination~     and flexion after tenotomy or tenodesis of the LHB.~      the investigators proposed a prospective and randomized study. All the patients treated in~     our department for an arthroscopic rotator cuff repair were included in this study after~     signed consent. Participants will complete isokinetic strength and endurance testing for~     elbow flexion and supination on the operative and nonoperative sides a minimum of 1 year~     after biceps tenotomy or tenodesis. The clinical evaluation included the range of motion~     measurement, Constant Score, Quick-DASH and SSV at 6 weeks, 3 months, 6 months and one year.~   "
57699|NCT02811744|"~     The proposed study aims to use 11C-acetate PET/CT to preliminarily test and validate methods~     for imaging astrocyte activation as an early indicator of neuroinflammation in Alzheimer's~     disease (AD). 11C-Acetate PET/CT has been shown to quantify astrocyte activation in vivo, but~     no reports have evaluated its potential in AD. The investigators propose to test 11C-Acetate~     PET/CT as a marker for astrocyte activation associated with pathologic amyloid deposition in~     AD. The investigators will compare binding between subjects with early stage AD and healthy~     controls. Further, the investigators will investigate the correlation between amyloid and~     acetate binding. If the investigators find increased astrocyte activation in response to~     cerebral amyloid by showing a group difference in brain acetate uptake between disease and~     controls or a strong correlation between acetate and amyloid PET/CT binding. Validating~     neuroinflammation markers in AD ultimately may guide therapeutic modulation of beneficial and~     damaging neuroinflammation to slow disease progression, as well as providing new insights~     into AD pathophysiology.~   "
57700|NCT02811731|"~     The purpose of this study is to compare the safety and pharmacokinetics of CKD-330~     (fixed-dose combination of Candesartan 16 mg and Amlodipine 5 mg) with coadministration of~     the two separate drugs in healthy male volunteers.~   "
57701|NCT02811718|"~     The aim of this study is to determine, whether the 3RP is feasible, accepted and efficacious~     and durable when delivered via Skype to patients with neurofibromatosis type 2 (NF2) who are~     deaf or have severe hearing loss using Communication Access Realtime Translation (CART)~     and/or American Sign Language (ASL).~      This will be a substudy of the IRB-approved protocol #2013P002605. It is the same study~     except it is looking at a particular sub-population: patients with NF2 who are hard of~     hearing.~   "
57702|NCT02811705|"~     This cohort study aims to assess the quality of life (or welfare) related to the health of~     children and adolescents with an non genetics auto-inflammatory disease PFAPA or Marshall~     syndrome to compare it to children or adolescents with recurrent fever genetics of Familial~     Mediterranean fever (FMF) in order to improve their overall care.~   "
57703|NCT02811692|"~     The French CODEX study is designed as a national database to describe, in routine medical~     practice, functional and anatomical responses to intravitreal Aflibercept injection, in a~     large population of anti-VGEF-naïve patients presenting with wet Age-related Macular~     Degeneration (wAMD), Central Retinal Vein Occlusion (CRVO),Branch Retinal Vein~     Occlusion(BRVO), or Diabetic Macular Edema (DME). This national database will gather~     databases from French private and public ophthalmologic centers.~   "
57704|NCT02811679|"~     This research study is studying Blinatumomab as a possible treatment for Indolent Non-Hodgkin~     Lymphoma (NHL).~   "
57705|NCT02811666|"~     Sarcopenia (loss of muscle mass and function) can be observed at any age and results of~     multiple factors (age, activity, inflammatory factors, nutritional status...). It deeply~     impacts the physical performance and the basal metabolism, and induces cardiovascular~     disorders, dyslipidemia, and diabetes. Sarcopenia appears like an independent factor~     decreasing the quality of life, exacerbating the toxicity of chemotherapy and increasing~     mortality for gastrointestinal cancer. However, few studies have demonstrated his impact on~     postoperative course in digestive oncology. The search for sarcopenia, complementary~     nutritional status, is now a source of great interest with 62 ongoing projects in the United~     States.~      The first objective of this study is to evaluate the impact of preoperative sarcopenia on~     30-days morbidity and mortality of patients operated on from poor prognosis gastrointestinal~     cancer (liver and pancreas). The second objective is to evaluate the impact of preoperative~     sarcopenia on the long term outcomes (12 months) on the same patients.~   "
57706|NCT02811653|"~     In AD (Alzheimer disease), the anatomic correlates of attention disorders (as evaluated by~     motor slowing) have not been thoroughly characterized.~   "
57707|NCT02811640|"~     Patients treated with peritoneal dialysis (PD) are at increased risk of developing mechanical~     complications such as dialysate leaks and hernias thought to be related to an increase in~     intra-abdominal pressure (IAP) secondary to the addition of dialysate to the abdomen.~     Resistance training has been shown to increase IAP but it is unclear in the general~     population and in patients treated with PD if this training increases the risk of developing~     hernias.~      This study is observing the difference in IAP pressure measurements obtained by the Stryker~     pressure monitor versus the standard IAP pressure measurements obtained with the insufflator~     at the time of PD catheter insertion.~   "
58199|NCT02805101|"~     This is a study aimed to compare two materials: (1) Biodentine and (2) MTA. These two~     materials are going to be tested in sealing accidental root perforations at the bifurcation~     areas. The study is going to be conducted as a randomized controlled trial.~   "
57708|NCT02811627|"~     Memantine, an N-methyl-D-aspartate receptor antagonist, has been explored as a possible~     therapeutic agent that reduces the excitatory (glutamate) - inhibitory (gamma amino-butyric~     acid, GABA) imbalance in autism pathology and improves social and communication deficits.~     While some studies have shown positive results, a large clinical trial failed to show benefit~     possibly because different subsets of autism responded differently to the treatment.~      The investigator proposes a pilot, exploratory, clinical follow-on study using proton~     magnetic resonance spectroscopy (1H-MRS) to determine whether baseline glutamate/GABA levels~     in certain regions of the brain may help predict treatment response to Memantine in autistic~     subjects. At study onset, subjects will be assessed on the behavioral scales such as the~     Aberrant Behavior Checklist and Clinical Global Impressions scale, followed by MRS imaging.~     Memantine treatment will be started post imaging. Assessment measures will be repeated at~     week 12 during treatment. Glutamate and GABA levels in brain regions will be correlated to~     improvements on assessment measures. Expected results include higher glutamate and/or lower~     GABA levels in the anterior cingulate cortex at baseline in responders to memantine. If the~     hypotheses are confirmed, it will provide evidence of a relevant neural biomarker to predict~     treatment response to memantine with important implications for clinical care including~     improving individualization of treatments.~   "
57709|NCT02811614|"~     The effectiveness of craniotomy in the treatment of intracerebral hemorrhage remains~     controversial. Two main types of minimally invasive surgery, endoscopic evacuation and~     stereotactic aspiration, have been attempted for hematoma removal and show some advantages.~     However, prospective and controlled studies are still lacking. This is a multi-center~     randomized controlled trial designed to determine whether minimally invasive surgeries will~     improve the outcome in patients with hypertensive intracerebral hemorrhage compared with~     craniotomy. Patients will be randomly assigned to endoscopy group, stereotactic aspiration~     group and craniotomy group in a 1:1:1 ratio.~   "
57710|NCT02811601|"~     This will be a single-arm prospective internally-controlled study. Patients will undergo~     percutaneous externally-assembled laparoscopic surgery where one or more 3 mm instruments are~     added or substituted for conventional 5 or 10 mm trocars.~   "
57711|NCT02811588|"~     The prevalence of chronic respiratory disease, including chronic obstructive pulmonary~     disease (COPD), is increasing in industrialized countries. Over the next decade deaths from~     COPD are projected to increase by more than 30% and COPD will become the third leading cause~     of death worldwide by 2030. There is robust scientific evidence that non-invasive ventilation~     (NIV) therapy is an effective option for most COPD patients hospitalized with acute~     hypercapnic respiratory failure secondary to an acute disease exacerbation. More recently,~     NIV has been shown to significantly improve survival and quality of life in COPD patients~     with chronic stable hypercapnic disease. These data represent an important advance in the~     field, and indicate that usage of NIV in patients with chronic stable hypercapnic COPD should~     increase. Such an increase would be expected to improve patient outcomes and have a~     beneficial impact on the significant healthcare burden incurred by these patients. However,~     the proportion of stable COPD patients with chronic hypercapnia is unknown. In addition,~     using NIV at home to treat COPD patients with hypercapnic (type 2) respiratory failure has~     not often been considered previously and there is a paucity of data regarding NIV usage~     patterns over time in this setting.~   "
57712|NCT02811575|"~     Type 2 diabetes is the predominant type of diabetes. Because a quiet evolution, it is~     difficult to have a rapid diagnose. A better knowledge about pathophysiological mechanisms at~     the origin of type 2 diabetes and about its complications could make it possible to improve~     the prevention and the treatment of this disease.~      Research team developped a new research axis : the microbiota of the intestinal mucosa. They~     proved a translocation process of intestinal bacteria from the intestinal mucosa to different~     tissue of the organism implicated in glucose homeostasis. This mechanism is involved in the~     type 2 diabetes development. A clinical study (MICIMAB) of predictive biomarkers of diabetes~     and obesity is ongoing.~      In parallel, the same team explored the role of intestinal immunity modifications in the~     bacteria translocation from the gut to the blood circulation. They already have some results~     on animal model but not yet in human. In animal model, a solid reduction of lymphocytes T CD4~     Th17 in the intestinal wall is responsable of the translocation of intestinal bacteria and in~     the induction of a metabolic inflammation wich promotes insulin resistance, abdominal obesity~     development and type 2 diabetes.~      The aim of this study is to explore this hypothesis in human to have therapeutic solution~     later.~   "
57713|NCT02811562|"~     Acquisition of knowledge and skills pertinent to the use of fibreoptic endoscopy is an~     important part of training in various medical and surgical specialties such as~     anesthesiology, emergency medicine, otolaryngology, and pulmonary medicine. It has been shown~     that there is a wide variation in the learning curves of residents and the number of attempts~     to achieve proficiency in performing upper airway endoscopy. recently, combined use of~     fiberoptic bronchoscope and videolaryngoscope has been suggested to be a good alternative.~     So, the aim of this study is to compare the number of attempt to achieve proficiency using~     fiberoptic bronchoscope alone or fiberoptic bronchoscope with Pentax-AWS.~   "
57714|NCT02811549|"~     The purpose of this feasibility study is to evaluate the benefit of unilateral implantation~     in adults who have severe to profound sensorineural hearing loss in one ear, and up to~     moderate sensorineural hearing loss in the other ear (asymmetric hearing loss).~   "
57715|NCT02811536|"~     Comparison of OCTA to conventional imaging modalities for the diagnosis of eye diseases~   "
57734|NCT02811263|"~     Hypoxic-ischemic encephalopathy (HIE) occurs when a baby gets reduced blood flow and oxygen~     to the brain near the time of birth. This results in death or neurologic disabilities~     including cerebral palsy and cognitive impairment in up to half of affected infants. This~     clinical trial will determine if the drug erythropoietin (Epo) added to hypothermia (usual~     therapy) will improve outcomes for infants suffering from HIE.~   "
57771|NCT02810782|"~     Three different drugs are used in a randomised, double blind, clinical multi-centre trial~     with three arms. Major objective is to investigate the duration of drug treatment based on~     the Finnegan score. Secondary objectives are to document weight gain, the need for adding a~     second drug when the first drug is not effective enough and possible side effects such as~     convulsions.~   "
57716|NCT02811523|"~     Sarcoma which has spread to the lungs is most often treated with surgery. Even with surgery,~     most patients will not be cured and will die from their disease, probably because of small~     cancer cells that are present in the lungs at the time of surgery, but cannot be seen or~     detected. It is for this reason that we are looking for a better treatment. Giving~     chemotherapy after surgery is generally not recommended because it has significant side~     effects and no benefit has been proven.~      This study is investigating a new technique for delivering chemotherapy directly into the~     lungs at the time of surgery. Delivering chemotherapy directly to the lungs could potentially~     kill any microscopic cancer cells that are present in the lungs at the time of surgery, while~     sparing other major organs in the body from the side effects of chemotherapy. This technique~     is called In Vivo Lung Perfusion (IVLP). This is a Phase I, non-randomized, dose escalation~     study that will act as a pilot study for a larger prospective, multicenter, controlled~     clinical trial. Patients who have bilateral disease will have one lung undergo IVLP and the~     other lung will remain untreated with the IVLP (the other lung will be treated as current~     standard of care - either surgery or radiation) as a control lung. The patients will undergo~     a posterolateral thoracotomy. Lung metastases will be identified by visualization or~     palpation. After surgical isolation of the lung by proximal control of pulmonary artery and~     veins, IVLP will be initiated. After 3 hours of IVLP, the lung metastases will be removed in~     the usual fashion. Patients will be cared for post-surgery according to institutional~     standards. The patients will be followed for up to 2 years. The primary endpoint is safety.~     Secondary endpoints include additional safety endpoints and efficacy.~   "
57717|NCT02811510|"~     The purpose of the study is to characterize the acute effects of cannabinoids in women~     relative to men and to begin probing the mechanisms that may underlie gender differences.~   "
57718|NCT02811497|"~     This is a phase 2 study of investigational drug, durvalumab given in combination with~     azacitidine (CC-486). The main purpose of this phase 2 study is to assess the antitumor~     activity of azacitidine in combination with durvalumab patients with microsatellite stable~     colorectal carcinoma (MSS-CRC), platinum resistant epithelial ovarian cancer type II (PR-OC),~     and estrogen receptor positive and HER2 negative breast cancer.~   "
57719|NCT02811484|"~     The purpose of this study is to see what the effects of using one or two additional diabetes~     drugs (dapagliflozin and exenatide-LAR) are on blood sugar levels in patients who are taking~     insulin. This research study is being done to investigate which of these commonly-used~     medications, medication combinations or increasing insulin dose is better.~   "
57720|NCT02811458|"~     Anxiety disorders are the most common mental disorders in community settings, and they are~     associated with significant psychological distress, functional and social impairment.~     Although pharmacological and psychological treatments for anxiety and depression have existed~     for several years now, only a minority of anxiety disorder sufferers are treated according to~     guidelines. Cognitive behavior therapy (CBT) is the most consistently efficacious~     psychological treatment for anxiety disorders, but implementation of CBT in primary care is~     challenging due to limited resources. Recent studies indicate that transdiagnostic group CBT~     for multiple anxiety disorders could be a promising alternative to individual CBT in primary~     care. The aim of the study is to examine the effectiveness of group CBT for anxiety disorders~     as a complement to usual care. The clinical trial will be conducted in three Health and~     Social Services Centers in the province of Québec (i.e. Sherbrooke, Laval and Québec).~     Patients will be French-speaking adults with anxiety disorders, and they will be randomly~     assigned to one of two treatment conditions: a) Transdiagnostic group CBT (12 weekly 2-hour~     sessions), b) usual care. The transdiagnostic group CBT will be offered as a differed~     intervention to participants in the usual care group after the 8-month follow up.~     Participants in both study arms will undergo a baseline clinical evaluation as well as~     outcome assessment interviews at post-treatment, 4, 8, and 12 month follow-up time-points.~     The primary study results will include improvement on a questionnaire on anxiety symptoms.~     Widespread implementation of group CBT could lead to better outcomes for a large number of~     patients living with anxiety.~   "
57721|NCT02811445|"~     I recently published significant associations between circulating gut bacteria-related~     metabolites with lean and skeletal muscle mass and with measures of physical function in~     older adults, evidence that suggests a role for gut bacteria on the maintenance of these~     outcomes. To date, studies aimed at identification of associations between gut bacteria with~     lean mass or with specific measures of physical function have yet to be reported.~     Accordingly, my over-arching hypothesis is that is gut bacteria are associated with and are~     causatively involved in mechanisms that underlie the maintenance of lean mass and physical~     function in older adults. Results obtained from the proposed study are intended as the basis~     for future studies aimed at targeted modulation of the gut microflora, which may be a novel~     and innovative means for improving lean mass and physical function and for addressing the~     public health priority of healthy aging in older adults.~   "
57722|NCT02811432|"~     There is uncertainty in the effect of KMC in unstable babies and there is a lack of evidence~     to guide how stable an infant must be to gain a mortality benefit from KMC. There is~     therefore, a need for a well-designed RCT that initiates KMC within 48 hours after birth to~     examine the effect on mortality versus conventional incubator care in infants weighing ≤2000g~     who are considered by the responsible clinician to be unstable. We propose such a parallel~     group RCT to be conducted at Jinja Hospital, a resource-limited regional referral facility in~     eastern Uganda.~   "
57723|NCT02811419|"~     This study is a randomized controlled trial to determine whether i-scan can improve the~     detection of conventional adenomas and sessile serrated adenomas/polyps.~   "
57765|NCT02810860|"~     Collection of PROMs (Patient Reported Outcome Measures) data from patients before and after~     an operation to remove their gallbladder for the treatment of symptomatic gallstones. This~     PROMs data will provide information to clinicians and trusts about the health gain following~     this type of surgery and the impact on patient's quality of life.~      This information will be collected by the implementation of the patient Website~     aboutmyop.org. This will not only allow patients to complete quality of life (PROMs)~     questionnaires online, but will also allow them to access information on their condition and~     necessary surgery, in addition to post-operative follow-up.~   "
57780|NCT02810665|"~     This is a cross-sectional study to determine the repeatability and concordance of visual~     acuity level measured with the original ETDRS letter, ETDRS Landolt C, and ETDRS numeric~     chart in Thai individuals.~   "
57724|NCT02811406|"~     Aims: To compare the rates of hypotension in patients with malignancy-related ascites~     undergoing abdominal paracentesis with and without prophylactic intravenous albumin infusion~      Methodology: Patients with symptomatic ascites secondary to underlying malignancy admitted to~     medical oncology inpatient service who require abdominal paracentesis will be enrolled.~     Patients with known portal hypertension based on SAAG (>11.1 mmol/L) will be excluded.~     Eligible patients are randomized 1:1 to two groups. During drainage of ascites fluid, one~     group will receive intravenous albumin infusion (50 ml/Litre of ascitic fluid drained),~     whereas the other group will not receive intravenous albumin infusion. Baseline parameters~     along with routine 4 hourly monitoring of blood pressure will be done. Episodes of~     hypotension (fall in SBP > 20 mmHg) will be compared between these two groups and~     significance tested using the chi-square test.~      Clinical significance: Ascites often occurs in the setting of advanced malignancy and~     drainage of ascites has been proven to provide symptomatic relief in this patient population~     with relatively short life expectancy. The use of intravenous albumin infusion is loosely~     extrapolated from studies in patients with liver cirrhosis undergoing abdominal paracentesis.~     To date, there have been no standard guidelines to guide practice and no studies looking at~     the use of intravenous albumin in this population. As the mechanisms of ascites are different~     in different malignancies, the indication of intravenous albumin is uncertain and perhaps~     unnecessary in this setting. We hope to understand more about the rates of hypotension during~     abdominal paracentesis in this population and to generate systematic data to guide clinical~     practice in this area.~   "
57725|NCT02811393|"~     The purpose of this study is to assess muscle function in women at least two years after~     being submitted to Roux-en-Y Gastric Bypass Surgery and compare with a control group~   "
57726|NCT02811380|"~     The primary objective of this trial was to determine Bactiguard coated BIP CVC's safety and~     performance and compare it to corresponding standard uncoated CVC.~   "
57727|NCT02811367|"~     The purpose of this study is to find out whether Self-HPV may be an accurate method for the~     follow-up of women with a history of HPV infection.~   "
57728|NCT02811354|"~     Circulating tumor DNA (ctDNA) is a highly specific and effective biomarker for the detection~     of EGFR mutation status. We hypothesise AZD9291 is efficacious in patients with EGFR~     sensitizing mutations and T790M detected in plasma ctDNA.~      This is a prospective, open label, multi-centre single arm phase II study assessing the~     efficacy and safety of AZD9291 monotherapy in patients with stage IIIB or IV harboring~     sensitising EGFR mutation (exon 19 deletions or exon 21 L858R substitution mutations) and~     T790M who have progressed following prior treatment with an approved EGFR TKI. Approximately~     106 subjects will be enrolled.~      All patients must have documented radiological progression on EGFR-TKI treatment and on the~     last treatment administered prior to enrolling in the study.~   "
57729|NCT02811341|"~     Scopolamine butylbromide might be helpful for the outcome of superior gastrointestinal~     endoscope examination.~   "
57730|NCT02811315|"~     The objective of the study is to evaluate the effect of frequency of use with a spacer on~     asthma control in Dutch patients with asthma during their daily clinical practice over 12~     weeks treatment.~   "
57731|NCT02811302|"~     PRODIGY is a prospective, multi-center, post-market, international cohort study. The primary~     objective of this study is to derive a score to identify subjects at risk to have respiratory~     depression (RD) episodes in patients undergoing opioid therapy in the hospital ward and~     monitored by capnography. The score will be derived by using subjects within the derivation~     cohort and internally validated using subjects within the validation cohort.~      The primary endpoint used to derive the score will be the occurrence of RD episodes derived~     by Capnostream 20p device memory data combined with clinical data and validated by an~     independent Clinical Endpoint Committee (CEC) during the study course.~   "
57732|NCT02811289|"~     Lean tissue intracellular triglycerides (ICTG) accretion is an important marker of lean~     tissue lipotoxicity that significantly contributes to the development of type 2 diabetes~     (T2D). The mechanisms leading to excess exposure of lean tissues to fatty acids involve~     metabolic dysfunctions of adipose tissues and lean tissues themselves. Understanding the role~     of white and brown adipose tissue in this metabolic dysfunction is particularly important in~     predicting, preventing and treating T2D and many of its associated cardiovascular~     complications.~      A recent breakthrough has been the demonstration that the acute oral administration of a β3~     adrenergic agonist, mirabegron (200 mg), significantly increases BAT glucose uptake in~     healthy individuals. This suggests that mirabegron could be used as a pharmacological tool to~     selectively activate BAT metabolism as part of the mechanistic studies on BAT. It also~     suggests that mirabegron could be used pharmacologically for chronic activation of BAT in~     clinical trials to treat obesity and T2D. However, there are some outstanding issues~     regarding the use of mirabegron to activate BAT. First, there has been no direct comparison~     of the effect of acute cold vs. mirabegron on BAT metabolism. Second, there has been no~     demonstration of the effect of mirabegron on BAT oxidative metabolism since glucose uptake is~     only a surrogate of BAT energy expenditure. Third, acute administration of mirabegron led to~     significant increases in blood pressure and cardiac work, suggesting that it may also enhance~     energy expenditure in other organs in addition to BAT, thus confounding the role of BAT in~     energy homeostasis. Therefore, much remains to be known about the effect of mirabegron on BAT~     and cardiac energy metabolism before this drug can be used as a selective activator of BAT~     oxidative metabolism. The purpose of this study is to directly compare BAT oxidative~     metabolism under cold vs. β3-adrenergic agonist stimulation in lean healthy individuals. The~     investigator hypothesizes that the acute oral administration of a lower dose of mirabegron~     (50 mg) will result in an increase in BAT oxidative metabolism and whole-body energy~     expenditure, to a similar extent as cold exposure, without influencing the cardiovascular~     responses previously seen with the higher dose (200 mg).~   "
57733|NCT02811276|"~     In the 19th century, researchers found out that the differences in the energy content of~     macronutrients (protein, carbohydrate and fat) can elicit different responses in the amount~     of calories individuals burn per day. It was demonstrated that protein has a metabolic~     advantage when compared to the other macronutrients (carbohydrate and fat). Since these~     findings, researchers all over the world started to study how diets differing in~     macronutrient distribution could result in different responses to energy metabolism. Diets~     with high amounts of protein (i.e. meats, eggs, dairy products, and grains) are becoming more~     popular, and studies have shown that when people eat high quantities of protein they lose~     weight and fat mass, maintain the weight loss, and burn more calories per day.~      The investigators hypothesize that giving high amounts of protein to healthy women will~     increase the amount of calories and fat they burn per day, increase their satiety, and~     improve health markers when compared to a normal diet. The increased protein level will be~     achieved using a nutrition supplement consisted of soy protein, yogurt and honey.~      To test this, the investigators plan to divide the participants in two groups: one will eat a~     normal diet and the other a diet with high amounts of protein during one and a half day.~     After one month they will change groups and eat the other diet for the same period of time.~     During this period consuming the diets (1.5 days), participants will stay inside a whole body~     calorimetry suite, which is similar to a hotel bedroom and is able to inform in the most~     precise way the amount of calories participants will burn and if they are burning more fat.~     Additionally, before and after each meal participants will have to answer a questionnaire~     about their appetite sensations and blood will also be collected to analyze health markers.~   "
57781|NCT02810652|"~     The purpose of this research study is to addresses the challenge of managing the unique~     perioperative needs of older cancer patients undergoing surgical resection.~   "
70430|NCT02645097|"~     This research is being done to compare two different saphenous nerve block locations and will~     help to determine which site best maintains knee strength and pain control.~   "
57735|NCT02811250|"~     Stereotactic radiotherapy is a technique that allows the delivery of a high dose of radiation~     over few fractions (3-6) with great precision. It thus allows tumor ablation and optimal~     preservation of healthy tissues. Initially developed in small-sized (<5 cm) lung cancers this~     technique it gives results very close and or even equivalent to those of surgery.~      Stereotactic radiotherapy of brain metastases of renal cancers has shown that high doses of~     radiation allows local control in 90 to 98% of cases. A study conducted in Sweden (Wersall et~     al.) underline the interest to develop stereotactic radiotherapy in primary renal tumors. In~     Cleveland (USA) two phase I studies are already underway.~      The investigators propose to develop a phase I study for tumors of less than 4 cm. As found~     in lung cancers, stereotactic radiotherapy can provide a non-invasive, painless and rapid (4~     to 5 fractions) method for the treatment of renal cancers with a high rate of local control.~      The primary objective is to define the maximal tolerated dose for one fraction in~     stereotactic mode of renal tumors ≤ 4 cm in length using an a four-step dose increase:~        -  Step 1: 4 x 8 Gy.~        -  Step 2: 5 x 8 Gy.~        -  Step 3: 4 x 10 Gy.~        -  Step 4: 4 x 12 Gy.~      The patients will be followed during treatment with evaluation of acute toxicities before~     each session, then at 15 days, 6 weeks, 3 months, 9 months, 12 months, and then every 6~     months for a total duration of 5 years after treatment.~   "
57736|NCT02811237|"~     Several studies have demonstrated the possibility of outpatient management or early discharge~     for certain patients presenting acute pulmonary embolism (PE), providing a suitable structure~     is in place.~      The approach featured in the most recent guidelines on acute PE of the European Society of~     Cardiology, refers to an all-cause mortality risk assessment using the Pulmonary Embolism~     Severity Index (PESI) score or the simplified PESI score (sPESI). The sPESI takes into~     account demographics (age), patient history (cancer, cardiac or respiratory disease), and~     clinical data (systolic blood pressure, heart rate, oxygen saturation). Outpatient care is~     offered to low-risk patients, providing that all the conditions pertaining to start~     anticoagulant treatment and follow-up at home are met.~      An alternative approach based on a list of simple criteria has been developed as the one used~     in HESTIA study. The main criteria included in the HESTIA rule consist of absence of the~     following: hemodynamic instability, need for oxygen therapy, high-risk of hemorrhage, renal~     or liver failure, or other medical or social conditions requiring hospitalization.~      The investigators hereby propose comparing these two approaches in an open-label, controlled~     randomized international trial with blinded adjudication of endpoints.~      The main objective is to demonstrate, in normotensive PE patients, that a strategy based on~     the HESTIA rule compared to a strategy based on the simplified PESI score is at least as safe~     as regards the 30-day-rate of adverse events (recurrent VTE, major bleeding or death).~      The major secondary objectives are to demonstrate, in normotensive PE patients, that a~     strategy based on the HESTIA rule compared to a strategy based on the simplified PESI score~     is more effective :~        -  As regards the rate of patients eventually managed as outpatients.~        -  As regards the rate of patients, in theory, eligible for outpatient care,~   "
57737|NCT02811224|"~     This is a prospective, gold standard observational trial designed to enroll consecutive,~     consenting ovarian cancer patients for the purpose of determining sensitivity of an assay~     that detects circulating tumor DNA. This observational pilot trial will also be used to~     examine the genetic variants/mutations present in the tumor tissue DNA.~   "
57738|NCT02811211|"~     This noninterventional study will assess genomic changes in the metabotropic glutamate~     receptor (mGluR) network in children and adolescents with ADHD.~   "
57739|NCT02811198|"~     The ultimate aim of this study is to identify a biomarker of suicide risk in MDD by measuring~     the hedonic spectrum (pain and reward responsivity), attention and its associated brain~     structures using brain scans (fMRI and DTI), as well as the stability of markers over time.~   "
57740|NCT02811185|"~     This is a single-centre, open-label, non-randomized clinical trial designed to monitor the~     occurrence of adverse events associated with [F-18]-FDG Injection manufactured by the Fedoruk~     Centre. [F-18]-FDG Injection used in this clinical trial will be identical to commercial~     [F-18]-FDG that is already used at Royal University Hospital (RUH).~   "
57741|NCT02811172|"~     Background Despite of advances in research, at the moment, various points related to the~     physiology of gestation and the etiology of severe diseases that can be developed in the~     course of it remain unknown. One of those aspects is the behavior of biomarkers~     (triglycerides, prolactin, glucose and cholesterol) during pregnancy, which experience a~     gradual increase in their levels until they reach the peak of hypertriglyceridemia, a few~     days before delivery. Several studies have reported that biomarkers experience a higher~     elevation in diabetic and obese pregnant women and in those women who suffer preeclampsia.~     The description of their behavior in different population of pregnant women (healthy women~     and women at risk) would identify the relation of these with some of the alterations that~     occurs more frequently during pregnancy.~      Objective The aim of this study is to develop a multi-paradigm biological model of systems to~     determine triglyceride, prolactin, glucose and cholesterol levels during pregnancy and its~     relation with lactogenesis in healthy and risk pregnant women.~      Methods A prospective cohort study will take place with women during pregnancy and lactation.~     Participating women will be divided into two groups. One group will be integrated by healthy~     women and the other group by pregnant women with a risk medical history. The personal, family~     and a detailed medical history will be collected in each group. A study of all the variables~     which influence the level of the mentioned biomarkers (triglycerides, cholesterol, glucose~     and prolactin) will be done.~      The universe consists in 4,300 women, who constitute the historical average deliveries during~     the semester in the city of Granada (Spain). The sample collection will be made in medical~     office's pregnancy control in Granada's hospitals, in their respective health centers and~     during the second half of 2015. The sample will be stratified and probabilistic.~     Peculiarities of pregnant women will be taken into account when calculating the size of the~     study sample. This sample will be made up of 224 women who comply with the inclusion criteria~     and that have signed the informed consent.~      To achieve the project objectives an organization comprising six theoretical and practical~     phases enabling the scientific development of the project.~      During the first phase, the technical and administrative preparation of the project is~     constructed. Thereafter, the work is divided into two action areas which encompass the~     collection and data modeling.~      The creation of a biological multi-paradigm computer simulation model of the levels of~     biomarkers in different months of pregnancy and in the various pathologies of pregnant women~     can be very effective to know the risks that involve high levels of lipids for the mother and~     for the baby.~   "
57742|NCT02811159|"~     To determine the safety of extended treatment with Proellex in women who have successfully~     completed either study ZPV-201 or ZPU-203 and meet eligibility criteria.~   "
57743|NCT02811146|"~     The study aims to demonstrate the efficacy of NIV continuously in cardiac rehabilitation~     programs, improvement of exercise tolerance, with consequent reflection in functional~     capacity and quality of life of this population.~   "
57744|NCT02811133|"~     This is an open trial which seeks to determine safety and tolerability of using inositol for~     children and adolescents with bipolar disorder and comorbid anxiety disorders with~     exploration of efficacy and dose response.~   "
57766|NCT02810847|"~     Around one child in fifty has a lazy eye (termed amblyopia) where the eye is structurally~     normal but the vision fails to develop correctly. Around half of these children also have a~     squint (strabismus) where each eye has a different direction of gaze. This condition is the~     commonest cause of visual impairment in one eye in children.~      This is a randomised control trial of wearing glasses alone (which will result in some visual~     improvement, termed refractive adaptation) and wearing glasses combined with using I-BiT~     Plus.~      The hypothesis is that using I-BiT Plus will result in an improved visual outcome.~   "
65648|NCT02707718|"~     Monocentric prospective study on consecutive patients attending the emergency department and~     suspected to have sepsis. Blood sampling for the measurement of a panel of biomarkers of~     interest in sepsis.~   "
57745|NCT02811120|"~     A previous cohort of 93 clinical trial participants received quadrivalent meningococcal~     conjugate vaccine, which includes strains ACW and Y, in their teenage years. The vaccine also~     contains components of diphtheria and tetanus which are linked to the meningitis components,~     in a process called conjugation, to improve their effectiveness.~      Participants are now aged 19-25 and will be invited to take part in this study, which will~     assess antibody persistence over time. This will provide information about the duration of~     protection by relating current antibody levels to those measured in the previous study, and~     will underpin the national immunisation schedule in providing optimal immunisation schedule.~     As well as the meningitis antibodies the investigators will assess diphtheria and tetanus~     antibody levels.~      The study will involve a single blood test of up to 8mL. Participants will be informed of~     their results and any with an antibody level that does not infer protection against strain W~     will be offered an extra dose of vaccine as part of a duty of care.~      The study will involve a single blood test of up to 8mL. Participants will be informed of~     their results and any with an antibody level that does not infer protection against strain W~     will be offered an extra dose of vaccine.~   "
57746|NCT02811107|"~     Anxiety is associated with discomfort but also with an increased risk of pain and/or~     analgesic consumption. A prescription of anxiolytics is very common in pre-anesthetic~     consultation but without considering the real anxiety level of the patients. The objective of~     this premedication is mainly to improve patient comfort, to reduce patient anxiety and to~     improve patient cooperation.~      According to a study conducted in the 1990s, 40 to 80% of patients are anxious before~     surgery.~      Consequences of anxiety are somatic (tachycardia, hypertension, difficulty to falling~     asleep), behavioural (aggressiveness, regression, fight against anaesthesia induction) and~     postoperative pain.~      Preoperative area is a place of convergence for patients who need surgery or an~     interventional procedure.~      Staying in the preoperative area may be a source of anxiety and may affect the patient~     management.~      The investigators will interview patients undergoing surgery or interventional procedure to~     assess their level of anxiety, pain and their experiences during their stay in preoperative~     area. The objective is to analyse the level of anxiety and / or pain and their clinical~     consequences, and then to assess the relationship with any potential premedication.~   "
57747|NCT02811094|"~     We aim to determine the accuracy or blood transcriptomic signatures to predict the occurrence~     of flares in patients with SLE that are clinically quiescent at inclusion Systemic Lupus~     Erythematosus (SLE) is a chronic auto-immune disease evolving by flares, with possible organ~     damage, and periods of remission. Current biological markers of disease activity are not~     sufficient to predict the occurrence of flares, monitor response to treatment or adapt~     therapeutic strategies. A previous study on genome-wide whole blood transcriptomic signatures~     in SLE (Chiche et al, Arthritis Rheumatology 2014) has identified gene panels associated with~     SLE disease activity~   "
57748|NCT02811081|"~     The aim of this clinical trial is to estimate the efficacy and safety of combined~     intervention with the intra-peritoneal normal saline instillation and pulmonary recruitment~     maneuver for reducing post-laparoscopic shoulder pain.~   "
57749|NCT02811068|"~     HPV vaccines have been included in the national immunisation schedule since 2008, firstly as~     the Cervarix vaccine which protects against two HPV types and in 2012 as the Gardasil vaccine~     which offers protection against a further two HPV types. This study will assess whether~     booster doses are indicated to protect females throughout their lifetime or if the~     vaccinations offered in early adolescence provide this by following up a cohort from a~     previous study where female adolescents were vaccinated 5-7 years ago.~   "
57750|NCT02811055|"~     Aldosterone regulation is mediated by hormonal control, and nervous control. Autonomic~     nervous system action could be mediated by neuropeptides in the adrenal gland. Therefore, in~     pathological conditions and especially in diabetes, low-renin hypertension with normal or~     high plasma aldosterone could be caused by sympathetic nervous system hypertonia.~      Data from the literature and previous in vitro research conducted in the investigators'~     laboratory (INSERM U982, University of Rouen) suggest that adrenal corticosteroid secretion~     might be controlled by sympathetic nervous system. This neurocrine regulation of~     corticosteroid secretion involves locally released neuropeptides. Among them, substance P is~     able to stimulate aldosterone and cortisol production via NK1 receptors. A previous clinical~     trial conducted at the University Hospital of Rouen, APHOS (NCT00977223) studied the effects~     of a NK1 receptor antagonist, aprepitant, on adrenocortical secretions in healthy volunteers.~      The aim of the present study is to investigate the effects of a NK1 receptor antagonist,~     aprepitant, on adrenocortical secretions in volunteers with diabetes associated with~     low-renin hypertension. Aprepitant is a drug already available for the treatment of nausea~     induced by chemotherapy.~      In the present phase II trial, plasma aldosterone and cortisol levels will be measured under~     treatment with aprepitant versus placebo, in both basal conditions and after activation of~     the adrenocortical function by upright posture. All volunteers will be given the two~     substances (aprepitant and placebo) in a random order during two 14 day-periods separated by~     a 21 day-wash-out.~      This study should allow to determine the role of substance P in the control of corticosteroid~     production in human with diabetes, associated with a low-renin hypertension.~   "
57751|NCT02811042|"~     The investigators test the hypothesis that oropharyngeal leak pressure and fiberoptic~     position differ between the size 2 LM Ambu AuraOnce and the LM Ambu AuraGain in non-paralyzed~     anaesthetized pediatric patients.~   "
57767|NCT02810834|"~     The central hypothesis of the Fueling Learning Through Exercise (FLEX) study is two~     innovative school-based physical activity programs (a walking/running program and a classroom~     activity break program) will increase school-time and total daily minutes children engage in~     moderate-to-vigorous physical activity, relative to controls, and that children who attend~     schools with these PA programs will demonstrate improved cognitive functioning, academic~     achievement, and attendance, relative to controls.~   "
57768|NCT02810821|"~     Deficiency in gonadal hormone has been considered to play a role in ageing related increased~     incidence of cardiovascular events. But the mechanism has not been fully elucidated. On the~     other hand, the dramatic increase in gonadotropin level didn't drew much attention when~     talking about the increased risk of cardiovascular disease during menopausal transition. This~     study aim to investigate the association between gonadal hormone, gonadotropin and long-term~     cardiovascular events.~   "
57752|NCT02811029|"~     A total of 40% of neurodevelopmental difficulties have been reported in very premature~     infants less than 32 weeks of age. The Epipage1 study reported a decreasing prevalence of~     cerebral palsy (9-6%) but a high prevalence of specific cognitive neurological difficulties~     and an increase in school failure.~      Neurocognitive difficulties are numerous: visuospatial dyspraxia, language disorders,~     executive function disorders as well as attention and behaviour disorders. Developmental~     language disorders have been rarely reported in the literature. This originally prompted our~     request i.e. PHRC 2010 National Multicenter: LAMOPRESCO. For the past 3 years this protocol~     has studied the language development of children who were born very prematurely, aged 3 and a~     half years free of cerebral palsy, in particular the impact of a short rehabilitation period,~     precise, at an early stage, and protocolized on a fundamental sensorimotor language. The~     principal assessment criterion was the measurement of phonology, the cornerstone of oral and~     written language in humans. The aim of the present project is an analysis of the effect that~     this specific language stimulation has on the learning of written language. The hypothesis is~     that a specific work modifying various aspects of a child's language, during the age of 3 to~     4, alters the development of phonological skills in a sustainable way. The acquisition of~     reading skills is basically dependent on the quality of its phonological components. The~     randomized study of children up to 8 years of age in a cohort of 150 children (LAMOPRESCO)~     will permit to confirm or refute this hypothesis. These increasing difficulties have been~     reported as regards the language understanding of 3 to 15 year old children. It is as if the~     initial difficulties and weaknesses, which moreover constituted oral language, prevented the~     use or development of neural networks, which became more complex and required both an oral~     and written language. Are these elements which constitute phonology, at an early stage,~     modifiable before the close of the clinically measurable developmental window?~   "
57753|NCT02811016|"~     The primary objective of the study is to investigate the effect of inhaled budesonide on the~     incidence of AMS. The primary study question to ask is:~      1. Does inhaled budesonide reduce the incidence of AMS after rapid and active ascent to 4559~     m?~      In addition, the secondary study questions to ask are:~        1. Does inhaled budesonide reduce the severity of AMS after rapid and active ascent to 4559~          m?~        2. Are the effects of inhaled budesonide on AMS incidence and severity related to its~          plasma concentration?~      Study medication Inhaled budesonide at 2 different concentrations (2 x 200 µg, 2 x 800 µg)~     versus placebo~      Study design~        -  Prospective, controlled, single-center study on 51 healthy volunteers at 4559 m [Capanna~          Regina Margherita (Margherita Hut), Italy]~        -  With regard to the intervention (inhaled budesonide) double-blinded and randomized~   "
57754|NCT02811003|"~     To evaluate bioinduction of new tissue and tendon healing after implantation of the Rotation~     Medical Bioinductive Implant used as adjunct to surgical repair in the treatment of~     insertional Achilles tendonitis.~   "
57755|NCT02810990|"~     The objective of the present study is to evaluate a new drug called bosutinib as it is~     believed that this agent may be able to predict an excellent prognosis in patients that did~     not obtain any benefit with other drugs before. Still, this needs to be proved and we hope~     this study is able to do so.~   "
57756|NCT02810977|"~     Anesthesiologists try to avoid complications with significant peri -operative morbidity and~     mortality such as bronchoaspiration in patients requiring a surgical procedure under~     anesthesia. Currently, this is achieved based on experts recommendations from the American~     Society of Anesthesiologists. However, there are tools like ultrasound that allow assessment~     of gastric content and volume. This tool allows to individualize each patient and base the~     decisions objectively. The investigators will assess gastric content and volume by ultrasound~     in patients who have fasted and require surgery at two University Hospitals.~   "
57757|NCT02810964|"~     The purpose of this study is to determine if taking a sulforaphane nutraceutical versus a~     placebo will reduce symptoms of schizophrenia when used in addition to standard antipsychotic~     medications.~   "
57758|NCT02810951|"~     The purpose of this study is to evaluate the safety of FCX-007, evaluate C7 expression and~     the presence of anchoring fibrils resulting from FCX-007 and to analyze wound healing as a~     result of FCX-007 administration in subjects with RDEB.~   "
57759|NCT02810938|"~     -  Prospective Atrial Flutter Ablation Registry investigating IntellaTip Mifi XP 8 mm~          technology and MVG isthmus ablation approach~        -  Design: National, multi-centre, prospective observational registry documenting right~          atrial isthmus ablation~        -  Observational treatment: Combination of MVG ablation strategy and the IntellaTip Mifi XP~          8 mm sensor technology~        -  Duration: Patients will be followed for 6 months post-ablation~   "
57760|NCT02810925|"~     The patients are randomized into 4 groups : Patients undergoing PENS of dermatome T6 in and a~     1200 Kcal diet (Group 1), Patients undergoing PENS T6 and a 2000 Kcal/day, Patients~     undergoing transcutaneous electrical neurostimulation (TENS) of Dermatomes T11-T12 and~     following a 1200 Kcal diet and those patients following only a 1200 Kcal diet (Group 4).~     Weight loss, appetite and ghrelin levels at baseline and after treatment are investigated.~   "
57761|NCT02810912|"~     Gastric regurgitation increases the risk of pulmonary aspiration in surgical patients~     receiving general anesthesia because of depression of gastro-esophageal reflux. In addition,~     some patients may have higher risk of aspiration as a result of reduced gastric emptying and~     gastroesophageal reflux, prolonged surgical time, and laparoscopic surgery. Second-generation~     supraglottic airway device (SAD) provides an additional channel to facilitate the drainage~     the gastric content to prevent from aspiration, which was routinely used in surgeries.~     Currently, multichannel intraluminal impedance-pH (MII-pH) monitoring, which combines~     multiple impedance channels to conventional pH catheters, is regarded as the most sensitive~     technique for detecting reflux events. Therefore, application of MII-pH monitoring on the~     SAD-based general anesthesia may help to detect ongoing reflux/regurgitation in the esophagus~     of patients during perioperative period. The hypothesis of the present study is that the~     occurrences of gastroesophageal regurgitation during general anesthesia may be influenced by~     the several factors, such as abdominal insufflation during laparoscopy, longer surgical time,~     Trendelenburg position, higher body weight, etc.~   "
57762|NCT02810899|"~     The purpose of this randomized, double-blind and placebo-controlled pilot study is to~     investigate whether dexmedetomidine when used as an adjuvant to general anesthesia can~     decrease the harmful effects of anesthesia and surgery on intelligence development in~     pediatric patients undergoing craniotomy.~   "
57763|NCT02810886|"~     Single arm, phase II exploratory trial to prospectively evaluate the impact of~     68Ga-PSMA-PET/CT on the therapeutic management of patients with biological recurrent prostate~     cancer and negative, equivocal or oligometastatic disease after routine imaging diagnostic~     work-up.~   "
57764|NCT02810873|"~     This clinical trial studies positron emission tomography imaging in using copper Cu 64~     TP3805in patients with breast cancer. Diagnostic procedures, such as positron emission~     tomography (PET) and positron emission mammography (PEM) scan, using Cu-64-TP3805 may help~     doctors find and diagnose breast cancer.~   "
57772|NCT02810769|"~     The first study of my PhD showed that acute supplementation of berry extracts can modulate~     cognitive behaviour in healthy adults. There is a growing body of evidence supporting an~     improvement in memory and learning performance in animal models following the ingestion of~     flavonoid rich fruits (Shukitt-Hale et al 2008;Spencer 2008; Spencer et al., 2008). However,~     study 2, showed no effect on any aspects of memory in healthy young adults after~     supplementation of the berry extracts. It is hypothesised that the lack of behavioural~     effects on memory of the berry juice in study 2 was because of the cohort used. These healthy~     adult participants were already performing near to their peak (Salthouse et al., 2009), and~     unlike study one, participants were not mentally fatigued enough to reveal subtle cognitive~     benefits.~      The aims of the study are to examine if acute supplementation of two berry extracts in an~     older population can augment memory, attention and executive function. Secondly, the time~     course of these behavioural effects will be measured by multiple cognitive assessments~     throughout the day after consumption of the extracts.~   "
57773|NCT02810756|"~     The pharmacokinetics of a new formulation with Pazopanib will be studied. This will be done~     in a patient cohort of n = 12.~   "
57774|NCT02810743|"~     Investigator-initiated, international, multicentre, randomized, open-label, (neo)adjuvant~     phase III study in target population (stage III, HER2-negative, BRCA1-like breast cancer~     patients) comparing optimized standard-dose chemotherapy with intensified, alkylating~     chemotherapy with stem cell rescue.~   "
57775|NCT02810730|"~     Pancreatic adenocarcinoma is the 4th leading cause of cancer in the USA. Its incidence is~     increasing both in France and in Europe, whereas all the other cancers are decreasing in~     Europe. Moreover, its seriousness is still high, with a mortality rate higher than the~     average incidence. The aim of PAPAFA study is to assess the prevalence of the pancreatic~     anomalies which can be revealed thanks to imaging, for patients having a 1st degree~     pancreatic adenocarcinoma familial history. This could allow detection of lesions which are~     less than 10 mm long, and improve the dark prognostic of this pathology.~   "
57776|NCT02810717|"~     Background:~      Theta-burst stimulation (TBS), a form of repetitive transcranial magnetic stimulation (rTMS)~     holds promise as an effective treatment for treatment resistant depression (TRD). rTMS has~     been linked to neuroplastic changes as shown using magnetic resonance imaging (MRI) and~     positron emission tomography (PET). Alterations in serotonin-1A receptor expression (5-HT1A)~     have been linked to major depression. Moreover, changes in 5-HT1A receptor binding - observed~     after pharmacological treatment, as well as after electroconvulsive therapy - has been linked~     to neuronal adaptations in response to these antidepressant treatments.~      Objectives of the study:~      Here, the aim is to investigate the effects of TBS over left and right dorsolateral~     prefrontal cortex on the 5-HT1A receptor binding in patients with TRD using PET. In addition,~     effects of iTBS on brain structure and function will be determined using functional,~     structural and perfusion MRI.~      Study population:~      80 patients with TRD who maintain their original medication regimen will be recruited.~      Study design:~      Longitudinal, randomized and double-blind clinical trial. 40 patients will receive active~     TBS, 40 patients will receive sham TBS for treatment duration of three weeks. Before and~     after three weeks of treatment, patients will be scanned using MRI and PET with the highly~     specific and selective radiotracer [carbonyl-11C]WAY100635. A follow-up visit and final~     examination will be performed 2 and 4 weeks after treatment for the active TBS group,~     respectively. Patients in the sham TBS arm will receive active TBS treatment immediately~     after the second MRI and PET scan.~      Relevance and implications of the study:~      This will be the worldwide first multimodal imaging study to investigate the effects of TBS~     on serotonin-1A receptor binding in TRD using PET. Thus, the study will add crucial knowledge~     to the existing literature on the effects of TMS on brain structure and function, related to~     antidepressant efficacy. Moreover, by combining molecular imaging of serotonergic~     neurotransmission with structural and functional MRI, the proposed study will increase the~     investigators knowledge on the serotonergic role in shaping brain morphology, microstructure~     and structural/functional connectivity. Taken together, the study has the potential to~     contribute to the development of personalized treatment, the reduction of personal suffering~     and the reduction of costs and occupational disability.~   "
57777|NCT02810704|"~     PEPPER is a randomized study comparing the three most commonly used anticoagulants in North~     America in patients who have elected to undergo primary or revision hip or knee joint~     replacement surgery. The anticoagulants being compared are enteric coated aspirin, low~     intensity warfarin, and rivaroxaban.~   "
57778|NCT02810691|"~     With improved survival, the clinical spectrum of cystic fibrosis (CF), a complex multi~     systemic disease, continue to evolve. A major emerging complication is CF related diabetes~     (CFRD) which is occurring in 40-50% of adults. Patients who develop CFRD are at increase risk~     of morbidity and mortality and they are also facing an increased medical burden with insulin~     therapy, the only recommended treatment. Accelerated decline in weight and/or pulmonary~     function start 2 to 4 years before CFRD onset and this period is characterized by frequent~     Post-Prandial Glycemic (PPG) excursions. Higher PPG excursions are associated with lower~     pulmonary function and it predicts future CFRD risk. To the improved nutritional status, lung~     function and survival of patients, the nutritional approach for patients with CF focuses on~     high-energy high-fat diet and a pancreatic enzyme supplementation. However, such diet also~     contributes to increased PPG excursions. Based on the beneficial effects of nutrition therapy~     to improve PPG in other forms of pre-diabetes and diabetes, extending such benefits to~     patients with CF is important. The investigators aim to test the feasibility and the~     effectiveness of a viscous fiber supplement to reduce PPG in adult patients with CF. Using a~     randomized crossover design, the investigators will study the impact of two doses of a~     viscous fiber supplement as compared to a placebo.~   "
57779|NCT02810678|"~     The study is a pragmatic cluster randomized trial that is being conducted in 5 countries,~     with sites in 4 cities in Canada, Benin, Ghana, Indonesia and Vietnam. The unit of~     randomization is the health facility (24 health facilities randomized). The trial tests a~     complex intervention-a two phase programmatic public health package which includes a~     standardized public health evaluation and analysis, to identify problems and barriers~     limiting Latent Tuberculosis Infection diagnosis and treatment among close contacts of active~     Tuberculosis cases. This will be followed by implementation of appropriate solutions and~     strengthening of the LTBI clinical program. The primary objective of the study is to increase~     the proportion of household contacts of index TB patients that start Latent Tuberculosis~     Infection treatment A secondary objective is to evaluate the cost effectiveness of this two~     phase intervention. If successful, this approach can be expanded throughout these countries.~     After initial preparations, including administrative and ethical review, all participating~     sites will be randomized to intervention or control. Immediately after this, Phase 1 will~     begin in intervention sites with the standardized public health evaluation to identify~     barriers to LTBI diagnosis and treatment initiation and the selection of solutions to be used~     in Phase 2. To ensure standardization of data gathering research staff will use (i) current~     indicators of the Latent Tuberculosis Infection cascade of care in intervention facilities~     (number of contacts per index case registered, investigated, started on treatment and~     completing treatment) and (ii) interviewer administered questionnaires for patients with~     active pulmonary Tuberculosis, adult and child household contacts and clinic staff. These~     questionnaires will assess latent Tuberculosis-related knowledge, attitudes and beliefs from~     the perspective of these different participants. Results from intervention sites in Phase 1~     will be analyzed, and used by the investigators, together with local public health officials,~     to decide on appropriate corrective solutions in each sites. Contact Investigation registries~     will also be developed with research staff from sites. In Phase 2, solutions for problems~     identified will be selected and implemented at the intervention sites, Contact Investigation~     registries will be implemented and clinical training will be provided to strengthen LTBI~     health care worker knowledge and clinical programs. Study outcomes and costs will be measured~     at all intervention and control sites throughout Phase 1 & 2. The main study will run for 18~     months. Upon completion of the main study, a 1 year cross over study will be conducted where~     control sites will receive a streamlined version of the intervention and original~     intervention sites will be used to evaluate the sustainability of the intervention. Results~     will be disseminated within each country through existing links with National Tuberculosis~     Programs, and through international organizations such as the World Health Organization.~   "
57782|NCT02810639|"~     Spinal morphine has been widely provided for acute postoperative analgesia. However, the~     analgesic effect of spinal morphine usually last 12-24 hours. Therefore the investigators are~     interested in the pain characteristics during the 2nd postoperative day. The investigators~     will also explore the regimens for pain therapy in our hospital.~   "
57783|NCT02810626|"~     The goal of this project will be to demonstrate that Synaptive Medical's Diffusion Tensor~     Imaging(DTI) product functionality used in pre-operative planning and intraoperative surgical~     navigation, improves clinical outcomes corresponding to a reduction in neurological and~     neuropsychological deficits in pediatric brain tumor surgery.~   "
57784|NCT02810613|"~     (Bio)medical research, particularly immunological, metabolic, transcriptional or biological~     assays, occasionally require the use of fresh blood (peripheral mononuclear cells) or urine.~     In order to comply with international guidelines for Good Clinical Practice, the~     investigators propose to establish a Mini Donor Bank to be able to obtain fresh blood or~     urine from voluntary donors. Recruitment of volunteers will be a continuous process.~     Volunteers will consent to occasional blood- or urine donation.~   "
57785|NCT02810600|"~     Phase-II, prospective, open label, no control group to assess the safety of 68Ga-DOTA-TATE~     injection in patients with suspected or diagnosed with tumors expressing somatostatin~     receptors. Each included patient will receive an administered dose of 50 mcg or less of the~     peptide (DOTA-TATE) and a range of activity between 100 - 200 MBq of 68Ga-DOTA-TATE.~      The efficacy of 68Ga-DOTA-TATE in assessing this kind of tumors has been proved by numerous~     studies.~   "
57786|NCT02810587|"~     This is a prospective case series which aims to determine the incidence of endophthalmitis~     following intravitreous anti-vascular endothelial growth factor (VEGF) injection comparing~     between eyes receiving post-injection antibiotics drops and those not receiving antibiotics~     drops treated at Chiang Mai University Hospital between May 2015 and April 2017 (2-year~     period).~   "
57787|NCT02810574|"~     The purpose of this study is to determine whether combining noninvasive brain stimulation~     with cognitive training can reduce craving in adults with tobacco use disorder.~   "
57788|NCT02810561|"~     The goal of this study is twofold. First the investigators would like to determine the~     trajectory of troponin leaks; if it can be shown that the participants who have only minimal~     elevations of their repeat troponin universally decrease on the 3rd level then future~     patients may see significantly improved length of stay. Second, given conflicting results in~     the literature, the investigators would like to determine if elevated troponin levels~     correlate to later cardiovascular complications. These complications will be defined as~     Death, Myocardial Infarction, Cardiovascular intervention (such as coronary artery stenting~     or bypass). As the investigator is a single hospital system in this county it is uniquely~     positioned to be able to review this retrospectively.~   "
57789|NCT02810548|"~     Background: the ultimate goal of periodontal therapy is the regeneration of periodontal~     tissues. Researches had demonstrated the benefits of platelet concentrates bine grafts in~     osseous regeneration in the areas of periodontal surgery.~      Aim of the study: to evaluate the effect of PRF with/without nanohydroxyapatite in~     periodontal intrabony defects.~   "
57790|NCT02810535|"~     The purpose of the study is to investigate the incidence of non-allergic rhinitis on a not~     selected group of young students (n=100-300). Students will be selected by public posting. In~     all students an allergy skin test will be performed. Then the local IgE of 24 subjects with~     non-allergic rhinitis will be compared to the local IgE of 24 subjects with allergic rhinitis~     and positive prick test to house dust mite. In addition 20 controlls will be investigated.~     Based on these investigations, the importance of local IgE and the IgE spectrum in~     conjunction with rhinitis should be further clarified.~   "
57791|NCT02810522|"~     This study is to support the regulatory application of OneTouch Select® Plus test strips in~     China. The blood glucose test strip is regulated as an In Vitro Diagnostic (IVD) product and~     China Food and Drug Administration (CFDA) regulation of IVDs should be complied with. The~     result of this study will be used to support regulatory filing in China.~      Investigational Product:~      OneTouch Select® Plus test strips (test with OneTouch Select® Plus glucose meter)~      Objectives:~        1. Assess Lay User and Health Care Professional (HCP) fingertip test results obtained on~          OneTouch Select® Plus BGMS compared to a validated method (YSI 2300 glucose analyzer~          results), according to International Standards Organization( ISO) 15197:2003(E) section~          8.0 and ISO 15197:2013(E)~        2. Lay User System Use evaluation.~        3. Assess the effectiveness of the instructions for use of OneTouch Select® Plus BGMS~          (Owner's booklet) and insert of test strips for the lay user.~      Comparator(control) Product:~      YSI 2300 glucose analyser~      Acceptance Criteria:~      User Performance of the OneTouch Select® Plus Blood Glucose Monitoring system(described as~     OneTouch Select Plus below) is met if the lay user and HCP results obtained with OneTouch~     Select Plus meet the requirement stated in section 7.4.1 of ISO () 15197:2003(E). Further to~     meet the requirements of ISO 15197:2013(E) , the lay user results obtained with OneTouch~     Select Plus should meet the requirements stated in section 8.2 of ISO 15197:2013(E). The~     effectiveness of instructions for use is met , if for each item on the Instructions for Use~     Questionnaire, the 90% lower confidence limit (90% LCL) for the correct response rate is~     equal to or greater than 70%.~      Study Design and subject population:~      This study is an open, non-randomized clinical evaluation and will be conducted at a minimum~     of 2 sites in China. At least 240 evaluable diabetic subjects who meet the enrolment criteria~     will participate in this evaluation.~      Study procedures:~        1. Each potential Subject (or legally authorized representative) reads and signs the~          Informed Consent Form, and receives a signed copy.~        2. After completing an in-clinic familiarization session, the Subject lances a fingertip,~          obtains a drop of blood large enough for two meter tests, and performs a self-test using~          OneTouch Select Plus BGMS.~        3. Study staff immediately performs a blood glucose test from the same blood drop with a~          second set of OneTouch Select Plus BGMS with the same lot of test strips.~        4. Within 5 minutes of the Subject's self-lancing, study staff collects blood from the same~          finger puncture for hematocrit and reference plasma glucose testing (duplicate tests on~          the YSI 2300 performed by study staff).~   "
57792|NCT02810509|"~     The current study aims to assess the quality of anticoagulation with warfarin in real world~     practice of secondary stroke prevention in Korean patients with Atrial fibrillation (AF) and~     to explore predictors for poor International Normalized Range (INR) control.~   "
57793|NCT02810496|"~     As the investigators observed a case of glucocorticoid mutation revealed by incidentally~     discovered bilateral adrenal nodular hyperplasia, it was postulated that this molecular~     anormality could be more frequent than previously described. To validate this hypothesis, it~     was decided to study 150 multicenter consecutive patients, presenting with incidentally~     discovered bilateral adrenal masses without clinical signs of Cushing's disease. In all these~     patients GR gene will be studied, mutations will be detected and described, functional~     disturbance will be tested. Usual polymorphisms will be described. Correlation between~     clinical signs, hormonal and morphological abnormalities and presence or absence of GR~     mutations will be searched.~   "
58030|NCT02807350|"~     The main objectives of this randomized trial comparing overminus lens treatment to~     non-overminus (spectacles without overminus or spectacles with plano lenses) are to~     determine:~        -  The long-term on-treatment effect of overminus treatment on distance intermittent~          exotropia (IXT) control score.~        -  The off-treatment effect of overminus treatment on distance IXT control score (following~          weaning and 3 months off treatment).~   "
57794|NCT02810483|"~     There is no specific treatment for core symptoms of PWS. Regarding behavioral and psychiatric~     symptoms (hyperphagia, imulsivity and self-mutilations), one of the only drug options~     consists in antipsychotics, that are not efficient and might be responsible for a worsening~     of the weight gain (major issue in PWS). An alternative therapeutic approach for behavioral~     disturbances has been suggested by some authors with topiramate (Epitomax®), an antiepileptic~     drug that can be used as a mood stabilizer and anti-impulsive. In addition, topiramate is~     used as a treatment for eating disorders because it induces loss of weight and appetite. This~     last effect might be useful in the case of SPW.~      Except for some clinical case reports, the investigators only found one open study for~     topiramate in SPW 8 patientssuggesting promising effects. There si however no placebo~     controlled study..~      Objective:~      To evaluate the efficacy of topiramate (200 mg / d) on Eating disorders (E), self Mutilations~     (M), irritability and Impulsivity (I), metabolic status, and tolerance among of PWS patients.~      Methodology:~      This is a multicenter (out-patients in Toulouse, Reims, Nantes and Paris and in-patients in~     Hendaye) 8 weeks double-blind placebo controlled study .~      Subjects (n = 125 for 112 analyzable) all having PWS, aged 12 years-old and more should have~     any of the following symptoms: E, M and U (see above). All subjects will be randomly~     allocated into two groups one taking a placebo, the other taking topiramate (50mg / day~     initially, increasing up to 50mg per week 200mg / day).~      The population of analyzable patients in and out patient will be of equal size (n = 56). The~     inclusion period is two years..~      Are excluded subjects with antipsychotic or mood stabilizer medication or topiramate.~      The primary endpoint will be the rate of responders, with response defined by obtaining a~     score of 1 or 2 on the CGI improvement after 8 weeks of treatment~      Other assessments, secondary endpoints :~        -  Clinic: Weight / Size / Self-injury behavior (french Echelle des Conduites Auto et~          Hétéro Aggressives, ECAHA))~        -  Psychometric: C-SHARP and A-SHARP / Conners (Impulsivity) / Dickens (Eating behavior for~          PWS)~        -  Organic: NFS, serum electrolytes, creatinine, ammonia plasma, serum bicarbonate, AST /~          ALT / GGT, ghrelin, fasting glucose, lipid profile and insulin, leptin, TG and HbA1c.~        -  Side effects of topiramate: SAPS / SANS and BPRS (hallucinations), anxiety scales and~          laboratory tests.~   "
57795|NCT02810470|"~     Malnutrition is a major health problem with serious consequences for the quality of life of~     elderly people: it increases the number of hospitalizations and lengths of stay, worsens~     functional dependency and increases morbidity and mortality rates There are numerous~     recommendations and tools to detect or to manage malnutrition and the prescription of Oral~     Nutritional Supplements (ONS) can be a solution. As the elderly suffer from food monotony, as~     well as age-related changes, which may or may not be associated with the presence of disease,~     it is necessary to ensure full ingestion of the prescribed supplements to optimize the~     benefits provided by these products. To achieve this it is necessary to know the chemosensory~     characteristics of foods enjoyed by hospitalized elderly people who are malnourished or at~     risk of malnutrition. The investigators make the hypothesis that by further optimizing taste~     and energy content of foods, consumption by the elderly and the health benefits would be~     improved.~   "
57796|NCT02810457|"~     The purpose of this research study is to compare the effectiveness and safety of FKB238~     against Avastin® in men and women with advanced/recurrent non squamous non-small cell lung~     cancer~   "
57797|NCT02810444|"~     This Phase III clinical study is to test efficacy, safety and pharmacokinetics of BT595 in~     treating patients with Primary Immunodeficiency (PID)~   "
57798|NCT02810418|"~     Background:~      LMB-100 is a man-made protein designed to kill cancer cells. LMB-100 targets a cancer marker~     called mesothelin. Mesothelin is found on the surface of many different tumors, including~     pancreatic cancer, but is made by a very small number of normal tissues. Other cancers that~     make mesothelin include mesothelioma, cholangiocarcinoma, thymic carcinoma, ovarian, lung,~     gastric, endometrial, cervical, and ampullary cancers. After binding to the mesothelin on~     tumors, LMB-100 can attack and kill cancer cells. Researchers want to see how well it works~     when given with and without nab-paclitaxel, a drug which treats pancreatic cancer.~      Objectives:~      Arm A- To find a safe dose of LMB-100 with a fixed standard dose of nab-paclitaxel in people~     with advanced pancreatic cancer. To see how well the combination of the two drugs reduce~     tumor size.~      Arm B- To find a safe dose of LMB-100 when it is given as a continuous infusion over several~     days.~      Eligibility:~      Arm A- Adults age 18 and older with advanced pancreatic cancer that has worsened after~     anti-cancer therapy.~      Arm B- Adults age 18 and older with advanced pancreatic cancer, mesothelioma or other solid~     tumor that makes mesothelin that has worsened after anti-cancer therapy~      Design:~      Participants will be screened with medical history and physical exam. They will give blood,~     urine, and tissue samples. They will have scans and x-rays.~      During each 21-day cycle:~        -  For Arm A~             -  Participants will get LMB-100 by an IV catheter on days 1, 3, and 5. This is a tube~               inserted in a vein, usually in the arm.~             -  Participants will get nab-paclitaxel by IV on days 1 and 8.~        -  For Arm B~             -  Participants will get LMB-100 by an IV catheter as a continuous infusion beginning~               on day 1 and continuing for 2-4 days~             -  Some participants will also get nab-paclitaxel by IV on days 1 and 8.~      All participants will get this combination for up to 2 cycles or until their disease worsens~     or they have intolerable side effects.~      Participants will have blood and urine tests and scans throughout the study.~      Participants will have a safety follow-up visit 3-6 weeks after treatment ends. If their~     disease remains stable or improves, they will be scanned every 6 weeks until their disease~     gets worse. Even if their disease gets worse, they or their doctor will be called to talk~     about their cancer status.~   "
57799|NCT02810405|"~     BACKGROUND:~      Cancer of any type is a serious disease and despite all the progress made from past research,~     there is still much that is poorly understood at the molecular level. Recent advances in~     biomedical technology platforms have emerged as critical tools for accelerating personalized~     medicine. The collection of human tissue specimens has been an invaluable resource for~     conducting translational cancer research using these developing technologies. The ultimate~     goal is to understand the molecular indicators of cancer development and progression. While~     it is ideal to be able to study clinical samples, specifically tissue biopsies, they are~     however precious and are often difficult to obtain in sufficient quantities or numbers to~     conduct proteomic or molecular profiling studies. There exists, however, a vast archive of~     pathologically characterized clinical samples in the form of formalin-fixed paraffin-embedded~     tissue blocks. The preservation of these tissue blocks and/or slides for long-term (years)~     storage is an important asset that aids in translational and clinical research. This protocol~     will describe the procedures for receiving, labeling and storing paraffin-embedded tissue~     blocks and/or slides until they are needed for future analysis. When blocks are ready for~     analysis, the requestor will then follow the IRB protocol specific to that study.~      OBJECTIVE:~      - To obtain tissue blocks and slides from outside pathology departments for cancer patients~     being treated at the Medical Oncology Branch (MOB) and Affiliates Center for Cancer Research~     (CCR), National Cancer Institute (NCI) in order to store them for future studies and analysis~     (e.g., using molecular technology platforms).~      ELIGIBILITY:~      - Patients suspected of having, or with biopsy proof of malignant disease will be evaluated~     in the Medical Oncology Branch and Affiliates Clinics, NCI.~      DESIGN:~        -  Tissue blocks and slides will be acquired from outside pathology departments and~          received by the Clinical Pharmacology Program of the MOB/CCR/NCI for coding.~        -  Bar-coded tissue blocks and slides will then be transferred to the Laboratory of~          Pathology/CCR/NCI for proper long-term storage.~   "
57810|NCT02810262|"~     Mortality due to non small cell lung cancers is the first cause of cancer death in men around~     the world. Lung adenocarcinoma regularly induces bone metastases responsible for high~     morbidity and impaired life quality. Overall survival of these patients is poor. Thus the~     investigators aimed to identify if some bone and metabolic parameters were associated with~     overall survival.~      Patients and Methods POUMOS is a prospective cohort of patients suffering from adenocarcinoma~     lung cancers with a first bone metastasis (stage IV). All patients have a bone biopsy with~     molecular status characterization of the tumor for EGFR, KRAS, BRAF and ALK. Bone metastasis~     localizations are obtained by bone scintigraphy or FDG-PET/CT. Whole body composition is~     obtained by DEXA scan (Hologic®). The investigators assessed also fasting blood levels of~     bone and metabolic biomarkers.~      Survival analyses will be performed using a proportional hazard regression model.~   "
58115|NCT02806232|"~     The Phase II study consisting of two parts, part 1 is open label, randomized, controlled and~     exploratory dose finding in children aged between 2 and 6 years infected with S. mansoni.~     Part 2 investigates efficacy and safety with the selected formulation and dosage in S.~     mansoni infected children aged between 3 months - 2 years.~   "
57800|NCT02810392|"~     Almost two-thirds of survivors have cognitive impairment (CI), manifested as memory,~     language, and judgement problems. Post-stroke CI at 2 weeks is a significant predictor of~     long-term functional outcome, and more generally, cognitive impairments have a major impact~     on functional outcome and ability to participate in rehabilitation. CI is associated with~     increased systemic inflammation. Intranasally-administered insulin is a promising new therapy~     for enhancing memory in patients with mild cognitive impairment (MCI) and Alzheimer's disease~     (AD), shown in multiple randomized controlled studies. Likely mechanisms of benefit are~     intranasal insulin's ability to restore normal cerebral insulin signaling. Based on the~     overlap in cerebral insulin resistance that occurs in both AD and post-stroke CI, we have~     designed an innovative proof-of-concept, feasibility trial designed to provide pilot data as~     to whether post-stroke survivor CI and caregiver burden is improved with intranasal insulin~     early after stroke. We will explore the impact of intranasal insulin on inflammatory~     biomarkers, since inflammation is a major underlying cause of CI, as shown by others and in~     our preliminary studies of VCAM-1. Specific Aims are: 1. Determine if patients with ischemic~     stroke randomized to intranasal insulin 20 IU BID for 3 weeks have improved cognition,~     compared to patients who receive intranasal saline. Primary outcome is a composite of (a)~     memory and executive function z scores. 2. To assess the impact of intranasal insulin vs~     saline on change in inflammatory biomarker levels (VCAM-1, TNF-alpha, TNFR-I and II) before~     and after the treatment period. 3. To measure differences in burden among caregivers of~     participants in the intranasal insulin vs intranasal saline groups. We will prospectively~     randomize 40 subjects to intranasal insulin (40 IU) vs saline treatment. Following baseline~     cognitive testing 2 weeks post stroke, subjects will receive the assigned treatment for 3~     weeks, followed by a 3-week washout period, with cognitive testing performed after the~     treatment and washout periods and again at 20 weeks. The proposed study will provide data on~     a promising method for treating cognitive function in stroke patients. If effective, our~     pilot data will set the stage for larger phase III clinical trials.~   "
57801|NCT02810379|"~     To prove that video about endoscopic retrograde cholangiopancreatography (ERCP) combined with~     written informed consent provides participants more information about the procedure, which~     can make participants understand the procedure well. Investigators advocate the development~     of institutional and national guidelines to ensure optimal practices of acquiring informed~     consent.~   "
57802|NCT02810366|"~     The objective of this study is to compare the performance of computer-coded verbal autopsies~     (CCVA) to physician-coded verbal autopsies (PCVA) at the population level. In order to do so~     a randomised control trial is being conducted in five districts of India. In each district,~     50% of deaths are randomly selected for PCVA and the rest for CCVA. The cause of death~     distribution for both groups are then compared within each district. If the performance of~     PCVA and CCVA are comparable, the attained distributions should be similar.~   "
57803|NCT02810353|"~     This study evaluates the dentoskeletal effects of the expander with differential opening in~     orthodontic patients in the mixed dentition. Half of participants will undergo rapid~     maxillary expansion (RME) using the expander with differential opening, while the other half~     will undergo RME using the conventional Hyrax expander.~   "
57804|NCT02810340|"~     MCV-5 is a vaccine being studied for use against a germ that causes infections of the brain~     and/or the blood. There are several licensed vaccines that protect against meningitis caused~     by 4 different types of the germ, but there is one type of the germ that these vaccines do~     not protect against. MCV-5 includes the same coverage as these other vaccines and includes a~     fifth type. The purpose of this study is to test how this vaccine affects adult human~     volunteers when compared to a licensed meningitis vaccine. Investigators will monitor~     volunteers for side effects and collect blood to test for antibodies.~   "
57805|NCT02810327|"~     The goal of this study is to better understand why some Alpha-1 genotype MZ (PiMZ)~     individuals develop chronic obstructive pulmonary disease (COPD) while others do not. This~     study will examine portions of the Alpha-1 gene that are not routinely tested to determine~     whether other changes in this gene correlate with development and progression of COPD.~     Participation involves responding to questionnaires about lung health and history, and~     performing an at-home finger stick to obtain blood spots using a test kit that is mailed. The~     blood provided will be used for genetic testing and correlation of results with COPD history.~     Participants will receive their results and access to genetic counseling at the conclusion of~     the study.~   "
57806|NCT02810314|"~     The study will evaluate connectivity regardless whether patients present a clinical type that~     requires medical treatment. In this point, investigators will include patients with~     progressive evolution as well as initial forms of the disease (CIS) and properly established~     forms of multiple sclerosis (MS) in remittent-recidivant (RR) forms. The researches will not~     focus on medical treatment as some of these clinical forms have no indication for disease~     modifying drugs.~   "
57807|NCT02810301|"~     Study to demonstrate the efficacy of Probiotic ES1 in alleviating symptoms of gluten~     sensitivity in non-celiac gluten sensitive subjects exposed to a small, fixed amount of~     gluten.~   "
57808|NCT02810288|"~     Respiratory adverse events continue to be the leading reason for perioperative critical~     events in children. It is crucial for the anaesthesiologist to anticipate, recognize and~     treat these respiratory adverse events. Respiratory adverse events are one of the major~     causes of morbidity and mortality during paediatric anaesthesia. To avoid trouble, one must~     be prepared for trouble: if a difficult airway is very likely, anaesthesia should be~     administered by experienced anaesthesiologists and should only be performed in a protected~     well-equipped area where the personnel adequately trained.~      This survey focuses on assessment and management of paediatric airway and highlights the~     unique challenges encountered in children.~   "
57809|NCT02810275|"~     Patients infected by HIV or HIV-HCV coinfected have higher survival due to the use of HAART,~     but survival is accompanied by increased morbidity and associated cardiovascular disease~     (CVD). Endothelial dysfunction is an early marker of atherogenesis, acting as an intermediate~     in the causal pathway of CVD. Folinic acid (FA) has been shown to reduce CVD outcomes,~     especially among individuals with hyperhomocisteinemia.~      To date, few studies provided consistent information about efficacy of pharmacological~     interventions that minimize damage to the vascular endothelium in patients infected by HIV or~     HIV-HCV coinfected. The main hypothesis of this study is that FA supplementation protects the~     vascular endothelium, and consequently might prevent subclinical atherosclerosis. Thus, the~     first step is to determine the efficacy of supplementation with FA, and to compare the effect~     between HIV and HIV-HCV coinfected.~   "
57817|NCT02810171|"~     Anxiety is among the most prevalent, costly and disabling illnesses and tends emerge early in~     childhood. Cognitive behavioral therapy (CBT) is the first-line treatment for early life~     anxiety, but as many as 40% of young patients who receive CBT fail to get better. The~     proposed study will examine brain changes marking positive response to CBT for anxiety and~     how these changes may differ in children compared adolescents. By helping us to understand~     how CBT works, this study will pave the way for new treatments to stop anxiety early.~   "
57811|NCT02810249|"~     HIV Pre-Exposure Prophylaxis (PrEP), in the form of the anti-retroviral pill Truvada©, has~     been approved by the FDA as a method for reducing HIV transmission rates in the population,~     particularly young men who have sex with men (YMSM). This study will use a qualitative design~     to interview 20-30, HIV-negative, 16-24 year old African American YMSM to: 1) identify and~     understand African American YMSM's, aged 16-24, cognitive and emotional processes in response~     to using PrEP to reduce their risk for HIV and 2) identify what factors (sociocultural,~     individual, experiences in health care, socioeconomic) influence African American YMSM's~     likely use of PrEP as a coping strategy for HIV prevention. Demographic information will be~     collected and analyzed using Statistical Analysis Software version 9.3. Individual interviews~     will be audio recorded and transcribed by a vetted transcription service for analysis. This~     is minimal risk to participants.~   "
57812|NCT02810236|"~     The investigator hypothesizes that a benign directed ultrasound, when performed after a~     normal digital mammogram, will provide women with focal breast pain additional reassurance~     that the etiology of their symptom is benign. 160 women over the age of thirty with focal~     breast pain who present to the Breast Imaging Clinic for evaluation between 3/1/2016 -~     7/1/2018 will be selected and randomized to three groups using a block randomization~     technique. All study participants will complete a survey assessing psychosocial factors, then~     receive a digital mammogram. Patients with a negative mammogram will continue on with the~     study and will either have a conversation about their negative mammogram with a radiologist~     or receive a directed ultrasound. A second survey will be conducted assessing psychosocial~     factors. All study participants who did not receive an ultrasound will receive an ultrasound~     so that all study participants are provided with the standard of care for focal breast pain.~     The results of the survey will be compared and appropriate statistical analyses such as an~     Analysis of Variance (ANOVA) test will be conducted to determine any statistically~     significant differences between the three randomized groups. The risks/safety issues of this~     study are believed to be minimal.~   "
57813|NCT02810223|"~     This is a single arm, open-label, multi-center study to determine the efficacy and safety of~     an experimental therapy called CART-19 in patients with chemo-refractory and relapsed B-cell~     ALL.~   "
57814|NCT02810210|"~     The Zika epidemic has spread into the three French Overseas Departments in the Caribbean~     (DFAs). It is therefore urgent to set up tools to collect clinical and paraclinical data for~     the evaluation of potential complications due to having ZIKV infection during pregnancy.~      This study is meant to collect, within usual care practices, clinical and paraclinical~     information (including imaging and laboratory results) as well as biological samples allowing~     the precise description of the consequences of ZIKV infection during pregnancy.~      This study is the 2nd arm of a global research program in the 3 French Overseas Departments~     in the Caribbean. It is complementary to the first arm (ZIKA-DFA-FE) consisting in the~     follow-up of women in the French Overseas Departments who are pregnant during the Zika~     epidemic period.~      The study population is made up of infants born during and up to 9 months after the end of~     the Zika epidemic period in the French Overseas Departments.~      The data and biological specimens collected for this project will be done so through the~     recommended standard of care which has been put in place considering the ZIKV epidemic in the~     3 French Overseas Departments, upholding existing recommendations (profession and/or~     recommendation from the public health authorities)~   "
57815|NCT02810197|"~     This is a multiwave longitudinal neuroimaging study in a cohort of direct survivors of 11/13~     Paris terrorist attacks. Both structural and functional brain imaging data will be collected~     at 8-12 months, 3 years, and 6 years after trauma in exposed participants as well as in~     control non-exposed participants. This project will capitalize on recent evidence showing~     that healthy participants can prevent unwanted images from entering consciousness using~     inhibitory control and memory suppression techniques, disrupting traces of the memories in~     sensory areas of the brain, and weakening their vividness and later reentrance. This process~     is believed to be affected in Post-traumatic stress disorder (PTSD) which is characterized by~     anxiety and persistent intrusive memory of the traumatic event with highly distressing~     contents. This project will thus provide a unique opportunity to observe the online and~     structural dysfunctions of intrusion control network following a severe psychological trauma~     and how such process may contribute to recovery and psychopathological dynamics. In addition,~     the disruption of social cognition and emotional processing following PTSD will also be~     investigated in relation to disrupted inhibitory control functioning.~   "
57816|NCT02810184|"~     Background~      Bone augmentation provides a solution for patients with a severely atrophic jaw to achieve~     immediate fixed prosthetic rehabilitation. Studies reporting total bone volume changes are~     lacking.~      Objectives~      The investigators aim to determine the level of total bone volume remodeling at 6, 24 and 36~     months post-surgery in patients who underwent immediate prosthetic rehabilitation through a~     cranial bone-grafted maxilla in combination with immediate provisional implant (IPI)~     placement.~      Study design~      A prospective, longitudinal study.~      All patients will be recruited at time of pre-surgical consultation.~      During the surgical procedure, autogenous cranial graft reconstruction of the jaw is carried~     out under general anaesthesia.~      Cone-beam CT (CBCT) scans (NewTom VGi evo, QR Verona, Italy) will be taken pre-operatively,~     and at different time-points post-operatively to evaluate the remodeling process of the bone~     after the grafting procedure with implant placements and assess the total bone volume changes~     up to 3 years post-surgically.~      CBCT scans will be send to the oral maxillofacial surgery (OMFS) Research Group within the~     Department of Imaging and Pathology (IMPATH), Catholic University Leuven (liaised with the~     clinical department of Oral and Maxillofacial Surgery; University Hospital Leuven) for~     analysis of the total bone volume.~      Data related to patient demographics, clinical diagnosis, the surgical procedure, IPI~     stability, and total bone volume at different time-points will be registered by a clinical~     research coordinator.~      Conclusion~      This prospective trial could add important knowledge to the field, and provide indications to~     improve future clinical pre-prosthetic management.~   "
57818|NCT02810158|"~     To answer the question whether a previously detected breath profile in patients suffering~     from obstructive sleep apnoea (OSA) can be found in a cohort of patients with suspected OSA~     using mass spectrometry (validation study).~   "
66402|NCT02697825|"~     This study involves observing and comparing Intraocular Pressure and Optic Nerve Sheath~     Diameter in steep trendelenburg position. Both observations will be done in same patient over~     the surgical duration.~   "
57819|NCT02810145|"~     We will determine the incidence and magnitude of cerebral desaturation in TBI. Adult patients~     (18 years and older) admitted to the Surgical/Trauma Intensive Care Unit (ICU) at the Health~     Sciences Center with a severe TBI will have cerebral oximetry monitoring instituted within 12~     hours of admission and continuing for 72 hours after placement. Decreases in regional~     cerebral oxygenation will be correlated with ICU hemodynamic parameters including mean~     arterial pressure, intracranial pressure, and arterial oxygen and carbon dioxide tension.~   "
57820|NCT02810132|"~     The study evaluates the effects of metformin treatment on myocardial efficiency in heart~     failure patients. 36 patients will be randomized to three months of metformin or placebo~     treatment in addition to their regular therapy.~      Hypothesis: Treatment with metformin in patients with heart failure has direct or indirect~     beneficial effects on left ventricular myocardial oxidative metabolism, myocardial efficiency~     and contractile function.~   "
57821|NCT02810119|"~     A Randomized, Double-Blind, Placebo-Controlled, Pilot Study to Evaluate the Efficacy and~     Safety of LO2A Eye Drops in Patients with Moderate to Severe Conjunctivochalasis~   "
57822|NCT02810106|"~     Cardiovascular diseases are important cause of death, and of these have highlighted the~     Coronary Artery Disease (CAD) and its various clinical manifestations. The chest pain~     suggestive of ischemic heart disease is frequent complaint in medical consultations and~     hospitalizations . Complementary tests and images exams for risk stratification as Cardiac~     Stress Test (ET), the Myocardial Perfusion scintigraphy of (SPECT) are established for risk~     stratification and assessment workup in suspected ischemic heart disease. Coronary tomography~     angiography (CTA) has emerged as a robust method for non-invasive assessment of CAD, showing~     data diagnostics that directly correlate with invasive coronary angiography. Recently, the~     Myocardial Perfusion by Tomography Computed (CTP) has emerged as a new technique to measure~     the flow limitation for coronary microcirculation. In clinical practice, the exercise testing~     with electrocardiogram changes compatible with myocardial ischemia can lead to other~     examinations for elucidation of ischemic etiology, the most usual myocardial scintigraphy.~     However, a SPECT without evidence of ischemia, does not explain ischemic electrocardiographic~     changes triggered by physical stress, although it is a good marker prognostic. A CTP is a~     emerging tool in the evaluation of myocardial ischemia. Recent studies point to a good~     accuracy of the method compared to nuclear medicine. To test this hypothesis, this study aims~     to evaluate whether the CTP has a better diagnostic performance in detecting of obstructive~     or not obstructive CAD compared to the SPECT in the population of patients with exercise~     stress testing compatible with myocardial ischemia, and the computed tomography angiography~     (CTA) as the reference method. In addition, data from the exercise test (functional capacity,~     hemodynamics, electrocardiogram changes) will be compared to findings of CTA and CTP.~   "
57823|NCT02810093|"~     Primary purpose :~      To develop a method to automatically extract and structure the information included in~     numerous medical records from breast cancer patients.~      Secondary purpose :~      With this procedure we can analyze the content of ten thousand anonymized textual medical~     records.~      This information should enable us to explore many subjects, such as:~        -  The impact of certain therapeutic procedures~        -  The characteristics of sub-groups of patients~        -  Pregnancy associated breast cancers~        -  Risk factors~   "
57824|NCT02810067|"~     Root coverage with acellular dermal matrix using the coronally positioned tunnel technique~     comparing two different donor materials~   "
57825|NCT02810054|"~     After performing the power calculation, healthy adult participants for the study will be~     randomly allocated into two groups. The intervention group will receive minimally invasive~     surgical techniques (MIST) with enamel matrix derivative (Emdogain) as a treatment of~     intrabony periodontal defect. The control group will receive minimally invasive surgical~     techniques (MIST) without enamel matrix derivative (Emdogain).~      Clinical attachment level (CAL) gain and periodontal pocket depth (PPD) reduction as well as~     the position of gingival margin (REC) as the main outcomes and the radiographic intrabony~     infill, bleeding on probing (BoP), full mouth plaque score (FMPS) and full mouth bleeding~     score (FMBS) as secondary outcome will be recorded for the participants by 3 examiners at~     three stages:~        1. Before the procedure as a baseline record.~        2. 6 months after surgery, all parameters EXCEPT intra oral periapical (PA) radiographs.~        3. 12 months after surgery.~      The readings will be recorded using The University of Michigan O Probe with William's~     Calibration OR Pressure Sensitive Periodontal Probe at 0.3 N to the nearest millimeter for~     the clinical attachment level gain (CAL), the periodontal pocket depth (PPD) and the position~     of gingival margin (REC), present or absent for the bleeding on probing (BoP), and intra oral~     periapical (PA) radiograph for crestal bone level assessment.~   "
57826|NCT02810041|"~     Overweight and obesity are public health problems worldwide. Even though heredity may be one~     of the causes the diseases, the vast majority of cases is rather linked to a sedentary~     lifestyle associated or not with a low-variety, high-calorie diet. Many diets and slimming~     methods propose low-calorie meals or physical exercise, and the consequences of these are~     sometimes negative with advancing age (muscle wasting). Certain studies have shown the~     efficacy of foods with antioxidant properties on the reduction of blood pressure, Low Density~     Lipoprotein (LDL)-cholesterol and weight or on the distribution of fat mass-lean mass. The~     investigators put forward the hypothesis that the daily consumption of two yoghurts~     containing XXS, a mixture of natural polyphenolic compounds -rich in quercetin- from plant~     extracts, could lead to weight loss, a better fat mass-lean mass distribution and an~     improvement in markers of oxidative stress in overweight persons aged 50 to 65 years.~   "
57827|NCT02810028|"~     In adults, muscle diseases are usually chronic long-term conditions that do not have a~     definitive cure. Supportive care has been shown to reduce complications from muscle disease~     and improved survival in some cases. However, there has been limited research to evaluate~     interventions that may improve quality of life (QoL) with this patient group. The QoL of~     those with MD is not just affected by the severity of their MD but also a variety of~     psychological variables. Based upon the knowledge of these psychological variables the~     investigators feel that a particular type of psychological intervention known as acceptance~     and commitment therapy (ACT) could potentially improve QoL in those with MD. The~     investigators therefore propose to test whether ACT does in fact improve QoL in those with MD~     by randomising 154 patients to receive either standard medical care plus a guided self-help~     ACT programme, or standard medical care only.~   "
57842|NCT02809820|"~     The Investigators will test the hypothesis that nonselective beta-blockers would have a more~     pronounced effect on platelet aggregation than selective beta-blockers in patients with acute~     coronary syndrome treated with dual anti platelet therapy.~   "
58116|NCT02806219|"~     This is a single center, open-label, Phase 1 bioequivalence (BE) study in healthy subjects~     designed to demonstrate the bioequivalence of a single dose of certolizumab pegol (CZP) 200mg~     when injected by means of a prefilled syringe (PFS, reference) or injected by means of a~     injection device (e-Device, test).~   "
57828|NCT02810015|"~     Temporomandibular disorders (TMD) are a group of conditions involving the temporomandibular~     joint (TMJ), masticatory muscles and associated structures. This broad complex of functional~     disorders often affects the face and jaws causing chronic pain, earaches, headaches,~     migraines, neck pain, and dysfunction in many people. Patients that do not find benefit with~     conservative management require surgical intervention. Recently, the use of botulinum toxin~     has proven effective and has the potential to bridge the gap between conservative therapy and~     surgical management resulting in less patients requiring invasive surgery. Objective: We aim~     to treat TMD of muscular origin using Botulinum toxin injections in the trigger points.~     Methods: Patients, whose pain originates from trigger points, will be enrolled in this~     prospective trial. This study will evaluate subjective and objective responses to treatment~     with botulinum toxin. The pair of masticatory muscles, masseter and temporalis, will be~     injected with 30 units and 20 units of botulinum toxin, respectively. Subjective outcomes~     such as pain and orofacial function on a visual analog scale as well as objective outcomes~     such as maximal interincisal mouth opening, tenderness to palpation to the temporalis and~     masseter muscles, maximal bite force measured by electromyogram and the reduction in muscle~     bulk due to muscle disuse atrophy will be assessed. Expected Results: We expect trigger~     points in these patients to disappear and the associated muscles to become partially~     paralyzed and relaxed. Consequently, we expect that the TMJ loading will be reduced and that~     the patient's overall functional ability will increase. We also expect that muscular~     hypertrophy volume from hyperactivity will decrease due to disuse atrophy and impact their~     cosmetic image positively. Overall, we hope these changes will result in a reduction in pain~     and headaches which will consequently improve the participant's diet, nutrition,~     psychological well being and quality of life.~   "
57829|NCT02810002|"~     One hundred infantry recruits will be randomly assigned to two groups. Injuries will be~     monitored.~   "
57830|NCT02809989|"~     The aim of this non-interventional study is to extend the knowledge on effectiveness of~     Ovaleap® (number of oocytes and pregnancy rate) during routine IVF- or ICSI-treatment using a~     Gonadotropin-releasing hormone (GnRH) antagonist protocol in a large number of patients.~   "
57831|NCT02809976|"~     The purpose of this study is to determine if topical ruxolitinib 1.5% will provide~     repigmentation in vitiligo lesions.~   "
57832|NCT02809963|"~     The aim of this study is to investigate the effect of selective blocking of the~     mineralocorticoid receptor in patients with type 2 diabetes on insulin resistance, lipid~     metabolism and myocardial function.~   "
57833|NCT02809950|"~     Many patients receiving opioid based analgesia after spinal surgery experience postoperative~     nausea and vomiting (PONV) despite prophylaxis and treatment with antiemetic agents.~     Dehydration caused by fasting prior to surgery is associated with the development of PONV.~     The aim of this study is to investigate the effect of oral carbohydrates loading prior to~     surgery in patients at high risk of PONV undergoing spinal surgery.~   "
57834|NCT02809937|"~     Delirium is a frequent postoperative complication. Its occurrence is associated with worse~     long-term outcomes. In a previous randomized controlled trial, prophylactic low-dose~     dexmedetomidine infusion during the early postoperative period decreased the incidence of~     delirium in elderly patients after surgery. The purpose of this 3-year follow-up study is to~     evaluate whether prophylactic low-dose dexmedetomidine infusion can improve the 3-year~     outcome in elderly patients recruited in the previous randomized controlled trial.~   "
57835|NCT02809924|"~     This study compares the use of simulation-based just-in-time training to video training in~     learning neonatal endotracheal intubation. Half of the participants will be trained using~     simulation-based just-in-time training and the other half using video training.~      The hypothesis are~      Primary hypothesis:~      In the Neonatal Intensive Care Unit, use of simulation-based just-in-time training, compared~     to video training, will increase the rate of successful clinical endotracheal intubation by~     20%.~      Secondary hypotheses:~      The investigators expect that simulation-based just-in-time training prior to clinical~     endotracheal intubation will decrease time to successful intubation and rate of endotracheal~     intubation related adverse events, namely mucosal trauma, oesophageal and endobronchial~     intubations. In addition, the investigators expect that simulation-based just-in-time~     training will increase residents' confidence level while performing clinical endotracheal~     intubation.~   "
57836|NCT02809911|"~     Evaluate the effectiveness of the Provant Therapy System compared to sham on pain sensitivity~     and nervous system response to various qualities of experimentally induced pain in the upper~     and lower extremities of subjects with painful peripheral diabetic neuropathy.~   "
57837|NCT02809898|"~     Our study aims to evaluate the role of ct-DNA and PBMC as biomarkers in the treatment of~     biliary tract cancer.~   "
57838|NCT02809885|"~     Hepatitis E virus (HEV) is an emerging disease. The genotype 1 and 2 are predominant in Asia~     and Africa, and are responsible for recurrent epidemics. Genotype 3 is the main genotype~     found in Europe and North America and is responsible for sporadic infections except for~     travel associated diseases.~      HEV had a principally asymptomatic form. However, it was recently demonstrated that it could~     lead to a chronic form, especially in immunosuppressed patients. Moreover, in liver~     transplanted patients the infection could mimic a rejection and lead to the loss of the~     transplant. In other immunosuppressed patients, chronic hepatitis lead to cirrhosis and its~     well-known complications (ascitis, digestive hemorrhage, liver failure...). There is a lack~     of information about the prevalence of this disease.~      In Canada the incidence of HEV infection was high (15-86% for liver transplanted children~     with liver tests disturbed). In Germany the prevalence was lower: 3,2% in liver & kidney~     transplanted children whereas 7,4% in control. It was shown in a retrospective study that in~     liver (and liver+kidney) transplanted children the prevalence in Lyon was around 8,3%.~      This study will determined in a prospective approach the HEV prevalence in kidney, lung,~     heart and bone marrow transplanted children in Lyon.~   "
57839|NCT02809872|"~     The aim of this study is the feasibility assessment of a simple and affordable model for the~     quantification of Pleural Effusion through thoracic Ultra Sounds images. Two US scans will be~     performed to measure: the height of Pleural Effusion column (hPEUS) and the area of the~     effusion in correspondence of the midline of hPEUS (aPEUS). The proposed model will estimate~     the Pleural effusion volume (PEVUS) by multiplying hPEUS and aPEUS. PEVUS will be compared~     with volumes estimated by CT scans (PEVCT), obtained within 24h from the US examination.~   "
57840|NCT02809846|"~     To study effects Quell has on opioid consumption and pain relief in patients with cancer.~   "
57841|NCT02809833|"~     This prospective, multicenter, non-interventional study will enroll participants from routine~     clinical practice in Germany who are receiving tocilizumab for RA. The objective of the study~     is systematic collection of data on use of tocilizumab in daily routine with special emphasis~     on treatment decision by the prescriber, compliance with Summary of Product Characteristics~     (SmPC), and documentation of relevant activity scores and adverse drug reactions (ADRs). The~     maximum observation period will be 12 months per participant.~   "
57843|NCT02809807|"~     Background: The gas mask is used to protect the aiways against respiratory hazards (CBRN~     agents). Within the CBRNE committee, speculations are that unprotected lungs would look like~     to those of COPD patients in post-exposure of some CBRNE agents. The aim of the study was to~     evaluate the impact of the gas mask on respiratory patterns and indexes of the respiratory~     effort. Methods: We are completing our study with 9 COPD patients to evaluate breathing~     patterns, index of respiratory efforts and blood gases. Three conditions have been tested in~     a randomized order: 1x baseline and 2x different canisters, with and without a mask (C4,~     Airboss Defence, Bromont, Canada). Airway pressure, inspiratory and expiratory flows have~     been measured. An esophageal catheter is introduced at the beginning of the study to measure~     esophageal pressure (Peso) and calculate indexes of respiratory effort (PTPeso, WOB). SpO2 is~     continuously measured and capillary blood bases are drawn at the end of each condition. Each~     condition lasts 10 minutes, data of the last 2 minutes at a steady state are considered for~     analyses. Results. We are compiling data and processing them for analysis.~   "
57844|NCT02809794|"~     The study is to evaluate the product reliability, therapy effectiveness and user feedback of~     a Continuous Positive Airway Pressure (CPAP) device in-home for up to 6 months.~   "
57845|NCT02809781|"~     The purpose of this study is to evaluate the safety and clinical effect of mesenchymal stem~     cells (MSCs) derived from human bone marrow at a dose of 1.0E+6 MSC/kg in subject for the~     therapy of Ankylosing spondylitis (AS) and to compare the efficacy of MSCs and Etanercept to~     treat this disease.~   "
57846|NCT02809768|"~     The purpose of this study is to determine the effects of concomitant administration with~     fluconazole, itraconazole, and rifampin on the pharmacokinetics (PK) of a single 20-mg dose~     of avatrombopag in healthy participants.~   "
57847|NCT02809755|"~     The purpose of this study is to determine the efficacy of sphenopalatine ganglion (SPG) block~     to prevent shoulder tip pain following primary laparoscopic gastric banding, band revision,~     band replacement, primary sleeve gastrectomy or revision of sleeve gastrectomy. Shoulder tip~     pain (STP) is a common problem after laparoscopic surgery, manifesting in the post-anesthesia~     care unit and for days or possibly weeks thereafter (Dixon 2005). Systemic analgesics~     including opioids and non-steroidal anti-inflammatory drugs (NSAIDs) do not reliably relieve~     STP. This study is designed to determine if the SPG block, a simple and low-risk procedure,~     effectively treats STP after laparoscopic bariatric surgery.~   "
57848|NCT02809742|"~     Enhanced patient safety and satisfaction have contributed to growing use of epidural labor~     analgesia. Epidural analgesia appears to be currently the most effective technique in~     reducing pain during labor. However, reduction in total dose of local anesthetic and thus~     motor blockade is crucial to improve the obstetric outcome. This technique has evolved from~     intermittent boluses by anesthesiologists to the current standard labor epidural analgesic~     regimens in many institutions in North America and Europe that consist of a local anesthetic~     in combination with an opioid delivered via continuous epidural infusion (CEI) with or~     without patient-controlled epidural analgesia (PCEA) boluses. Recently,a new mode of~     administration has been used: regular bolus of low concentration local anesthetic +~     intermittent bolus (PIEB). This technique would offer safe and superior quality labor~     analgesia and greater maternal satisfaction by reducing total amount of the drug combination.~      The primary outcome was to evaluate the analgesic efficacy of PIEB epidural drug delivery in~     terms of visual analogue scale satisfaction (VAS) score in a large cohort of patients. The~     secondary outcomes were to measure the degree of motor blockade, neonatal and obstetric~     outcomes, total drug dose and incidence of pain that required top-up administration~     (breakthrough pain)~   "
57849|NCT02809729|"~     Breast cancer is the most frequent malignancy in the female population Brazilian, except~     non-melanoma skin tumors. Surgery plays an important role in regional spot disease control~     and the definition of parameters for the adjuvant treatment indication. Surgical site~     infections (SSI) are defined as wound infections occur following invasive procedures,~     corresponding to 14-16% of all infections nosocomial in hospitalized patients, the most~     common among patients surgical. SSIs should be examined as potential wound contamination~     surgical, understood as the number of micro-organisms in the body and / or tissue being~     operated. Considering this aspect, the cancer surgery breast are classified by their~     potential for contamination by clean. The use of antibiotics to prevent the SSI in~     mastectomies is not standardized in Handbook of National Health Surveillance Agency due to~     the effectiveness of undocumented prophylaxis Thus the use of antibiotics may vary among~     services. So this randomized clinical trial to evaluate the influence of the use of~     Prophylactic antibiotics in SSI rates in oncological breast surgery.~   "
57850|NCT02809716|"~     This research clinical trial studies high definition single cell analysis in blood and tissue~     samples from patients with colorectal cancer which has spread to the liver. High definition~     single cell analysis allows doctors to study the properties of cancer cells that are~     sometimes found in the blood of patients and to determine how the genes and proteins in them~     may change over time. Studying samples from patients with colorectal cancer in the laboratory~     may help doctors learn more about how cancer spreads, as well as how to predict the disease~     outcomes in patients with cancer.~   "
57851|NCT02809703|"~     The objective of the study is to determine the quality of life of patients in the years~     following treatment with extracorporeal membrane oxygenation (ECMO). The study population~     will include all adults treated with any configuration of ECMO at Duke University Medical~     Center during the period of Jan 1, 2009 and Dec 31, 2015. Patient's will be contacted by~     direct mail, in conjunction with a surgeon who performed their ECMO procedure or managed them~     while on ECMO, and asked to complete a validated survey (WHOQOL-Bref) which assesses quality~     of life. In addition, patients will be asked to opt-in to participate in a phone survey in~     which they can give a narrative about their ICU experience and answer specific questions~     regarding long-term comorbidities. Data will be stored in a secure online server which is~     HIPAA compliant and analyzed by the department of anesthesiology statistical support~     services. De-identified data will be shared with the WHO as specified in their usage~     agreement.~   "
57902|NCT02809027|"~     The purpose of this study is to determine ginger is effective in the prevention of abdominal~     distention in post Cesarean section patient.~   "
58367|NCT02802917|"~     The primary objective of this study was to compare the human eye stinging potential of~     experimental formulas of sun care products [Sun Protection Factor (SPF) 50 Y49 091, SPF 50~     X15 158, SPF 50 X15 160 and SPF 50 X57 162 compared to an industry standard shampoo mixture.~   "
57852|NCT02809690|"~     This pilot clinical trial studies how well fluorine F 18 d-FMAU (18F-FMAU) positron emission~     tomography (PET)/computed tomography (CT) works in diagnosing and characterizing prostate~     cancer. A PET/CT scan is an imaging test that uses a small amount of radioactive tracer that~     is given through the vein to take detailed pictures of areas inside the body where the tracer~     is taken up. Radiotracers such as 18F-FMAU may help to find the cancer and see how far the~     disease has spread.~   "
57853|NCT02809677|"~     The investigators propose a one-year, repeated measures, within-subject design to examine the~     impact of improved caregiver depression on child asthma outcomes. A cross-lagged panel~     modeling (CLPM) for longitudinal data will be fit using a maximum likelihood structural~     equation model (SEM) in order to explore longitudinal mediation between asthma outcomes~     (asthma control, spirometry, quality of life (QOL)) and depressive symptoms. CLPM will test~     whether caregiver improvement preceded child asthma improvement, and SEM will test whether~     improved adherence and/or decreased child anxiety/depression mediated the effect. The~     investigators considered a randomized control trial, but it would not be ethically acceptable~     to withhold medication from caregivers diagnosed with Major Depressive Disorder (MDD) for the~     proposed one-year duration of the study. It is unlikely that potential participants in the~     study would find this acceptable. Furthermore a controlled design is not necessary since the~     investigators are not testing the efficacy of antidepressants for depression, but rather the~     impact of improvement on caregiver depression on the child.~   "
57854|NCT02809664|"~     Our goal is to demonstrate the feasibility of laying uncomplicated ultrasound-guided central~     subclavian catheter by supraclavicular route in the newborn.~   "
57855|NCT02809651|"~     The investigators prospectively want to use the Infrascanner in patients with ischemic~     stroke, patients with brain surgery, patients with brain tumors, patients with intracranial~     hemorrhage and patients with a normal CT scan of the brain as part of a diagnostic work-up~     after head trauma or headache to determine to positive and negative predictive value of the~     Infrascanner in these different settings.~   "
57856|NCT02809638|"~     In clinical practice, compression ultrasound (CUS) has become an easy and reliable~     noninvasive tool for the diagnosis of deep vein thrombosis (DVT).~      Currently there are not validated methods to assess the biological age of venous thrombus,~     and the date of onset of thrombosis. One potential technique to age DVT is ultrasound~     elastography (UE). UE is a noninvasive technique to measure tissue hardness, and it is well~     known that thrombi harden as they age. The aim of this study will be to assess the ability of~     UE to distinguish acute from chronic DVT. The investigators will evaluate prospectively all~     consecutive outpatients presenting with clinically suspected unprovoked DVT of the lower~     limbs, and those having a previous diagnosis of DVT for the scheduled 3 months visit of~     follow-up, for a period of about one year. All the enrolled patients will undergo to the CUS~     of the lower limbs, and at the same time to the ultrasound elastography by the physician~     expert in vascular ultrasound. The specialist performing both examinations will be unaware of~     the time of onset of DVT (acute or chronic). Then the patients will be divided into two~     groups (group A: patients with acute DVT; group B: patients with chronic DVT at the 3rd month~     of follow-up). Each examination (CUS and ultrasound elastography) will be repeated three~     times in the same patient at the same visit, to assess the reproducibility of the technique.~     The demographic data, medical history, physical examination and the results of CUS and~     ultrasound elastography will be collected in a case report form (CRF) by another investigator~     who does not perform the examinations. The blinded CRF will be submitted to a dedicated~     committee for statistical analysis.~   "
57857|NCT02809625|"~     Brucellosis, also known as Mediterranean fever, undulant fever, or Malta fever is a zoonotic~     disease caused by Brucella infection.With the rapid development of animal husbandry and~     aquaculture and increasing consumption of dairy products in urban residents, the incidence of~     this disease in Inner Mongolia and even in the mainland area of China is significantly~     increased.~      The disease can damage multiple systems including nervous system, circulatory system,~     reproductive system and bone joints, etc. The sooner the diagnosis of brucellar spondylitis~     is diagnosed and treated, the better will be the prognosis of the patients which can prevent~     the development of severe complications and diminish the need for surgical therapy. Thus the~     early diagnosis of brucellar spondylitis was of great significance.We quantitatively analyzed~     the brucellar spondylitis with DCE-MRI to explore the application of DCE-MRI in the early~     diagnosis of brucellar spondylitis.~   "
57858|NCT02809612|"~     Vulvodynia is a very common but vastly under-diagnosed and under-treated gynaecological~     condition that leads to extreme suffering for both the women involved but also their~     partners. It has also been shown to be associated with poor quality of life, leading to~     depression and anxiety states. When left untreated, the condition takes a very long time to~     resolve, with a substantial associated disability and suffering. Both psycho-education and~     internet-based interventions have been shown to be highly successful while they can be quite~     affordable. This makes them highly cost-effective. The present study aims at evaluating the~     effectiveness of such an intervention among a vulvodynia patient population from the clinics~     of Uppsala, Falun, Orebro and Gävle. The patients will be recruited by treating physicians~     and given access to the internet-based platform, where they will fill out questionnaires~     during four different time-points, after randomization to the control or the intervention~     group. The intervention group will also have access to multiple activities and information~     material uploaded in the internet-based platform. Differences in pain, quality of life and~     mental health parameter outcomes will be assessed at the end of the study. Should this~     intervention prove effective, it will be implemented in clinical praxis in the four regions.~   "
57859|NCT02809599|"~     The study evaluates a theory-based educational intervention and implementation strategy on~     the use of the Dix-Hallpike test (DHT) and Canalith Repositioning Maneuver (CRM) in a~     community Emergency Department (ED) setting. The DHT and CRM are used to diagnose and treat~     Benign Paroxysmal Positional Vertigo (BPPV).~   "
57919|NCT02808806|"~     The purpose of the ARTEMIS trial is to investigate if real-time feedback to caregivers~     reduces the time between patient's first medical contact and start of intravenous~     thrombolysis and/or intraarterial thrombectomy in patients with acute ischemic stroke.~   "
57920|NCT02808793|"~     This is a Phase 1 study to investigate the safety and tolerability of AK002 in patients with~     indolent systemic mastocytosis (ISM).~   "
57860|NCT02809586|"~     Social media provides frequent interaction with online social networks, increasing exposure~     to peer influences, which could affect alcohol use in negative or positive ways. The proposed~     study will recruit adolescents and emerging adults using social media ads, and conduct online~     screening, enrolling 900 risky drinkers in a randomized controlled trial comparing three~     conditions: 8-week Social Media Intervention + Incentives, 8-week Social Media Intervention~     Only, and an e-news attention control condition. These innovative design features will~     provide the critical next step in harnessing social media to reduce alcohol misuse, which~     could have enormous public health impact by altering the alcohol use trajectories of youth.~   "
57861|NCT02809573|"~     The purpose of this dose-escalation study is to assess the safety and tolerability of~     treatment with Chidamide in a range of doses combined with CHOP in fixed dose in patients~     with newly diagnosed peripheral T-cell lymphoma.~   "
57862|NCT02809560|"~     Asthma affects about 10% of children and 6% of adults in industrialized countries.~     Lymphocytes (L) Th2, a T cell population (LT) producing interleukin (IL) -4, 5 and 13 are~     broadly involved in this pathology in experimental models and in humans. Many studies show~     that the signaling pathways activated by the commitment of T receiver differ depending LT.~     The identification of specific signaling pathways links to Th2 offer new therapeutic~     approaches. Precedent study showed that mouse Th2 selectively expressed related to calcium~     channels sensitive channels Cav1 voltage, normally found in excitable cells where they are~     defined as receivers dihydropyridine (DHP).~      The goal of the present study is to show the presence of Cav1 channels in inflammatory cells~     in allergic asthmatics and show overexpression of these channels in the peripheral blood~     mononuclear cells from asthmatic subjects before and / or after stimulation with the TCR in~     comparison with controls.~   "
57863|NCT02809547|"~     It is important that patients who suffer from Rheumatoid Arthritis (RA) have their disease~     monitored at an early stage, as well as when it is established. Presently, if a patient is to~     be assessed by means of disease activity scores and blood tests, they must attend a hospital~     appointment, which can be difficult for patients who live far from the clinic. It would be~     beneficial to be able to monitor and reliably define and report a disease 'flare' at home.~     Quite often, by the time the patient attends for an appointment, flare ups have subsided.~     This study will evaluate the possibility for patients to take their own blood samples in the~     comfort of their own home, by transferring finger prick blood droplets to a dried blood spot~     sample (DBSS) card. Patients would then send the cards to the laboratory to test for~     clinically relevant protein markers. The feasibility of 'remote' monitoring of the patient's~     disease will be explored.~   "
57864|NCT02809534|"~     To assess the primary effects and safety of Anlotinib with placebo in patients with~     Hepatocellular Carcinoma(HCC).~   "
57865|NCT02809521|"~     The purpose of the study is to see if one's liking and awareness of different types of~     activities is related to one's activity pattern.~   "
57866|NCT02809508|"~     The purpose of FiSK Junior is to investigate whether intake of oily fish compared to poultry~     affects cardiovascular risk markers, cognitive function, and behaviour in healthy children.~   "
57867|NCT02809495|"~     Prostate cancer (PC) is the most common non-skin tumor in men and the second leading cause of~     death from cancer in Brazil. It accounts for 13.8% of deaths from cancer in males, similar to~     what happens with breast cancer in females, corresponding to 15.8% of cancer deaths in women.~     Mobile applications, software developed for smartphones and tablets used for many different~     purposes (games, communication, entertainment etc) have become important tools of mHealth~     (Mobile Health in Portuguese - mobile health) as they allow remote support to patients or~     self-promotion of health care. It has been used globally to assist in the treatment and~     control of various diseases such as diabetes, physical inactivity, and many others. In~     oncology there are several applications developed to assist in the monitoring and treatment~     of various cancers such as gastric and breast cancer. So far it has not developed an~     application for follow-up of patients with PC, to capture data on satisfaction of~     post-treatment patient regarding the comorbidity of surgery, and also loyalty and adherence~     of patients to follow-up in offices allowing a possible intervention it is done at the right~     time. Nor was made compared to assess whether there is benefit in using this application.~     Thus, the objective of this work is to develop an application for smartphones facing the~     postoperative follow-up of patients undergoing robotic radical prostatectomy and compare~     adherence to treatment compared to accompanied by traditional way patient. In addition, we~     will evaluate the progress of the IPSS, ICIQ and IIEF-5 compared to preoperatively in~     patients undergoing prostatectomy robotic radical.~   "
57868|NCT02809482|"~     Peripheral tissues (e.g. liver, adipose, muscle) express self-sustained circadian clocks that~     coordinate daily metabolic rhythms. The timing of clock rhythms in peripheral tissues is~     highly sensitive to feeding-fasting signals across the sleep-wake transition. Nutritional~     insults such as high fat overfeeding (HF-OF) have been shown to attenuate clock gene~     expression in peripheral tissues resulting in a deleterious re-programming of the circadian~     metabolome. Studies in humans have only superficially investigated how the circadian clock~     machinery is impacted by nutritional signals. The overall goal of this pilot project is to~     take the first steps toward developing translational methods to investigate links between~     changes in energy flux and the circadian system in human tissues. Using an innovative ex vivo~     cell culture approach the investigators will examine the impact of 3-days of HF-OF compared~     to eucaloric (EU) feeding on the expression of core clock genes in human subcutaneous adipose~     tissue (SAT). The Investigators hypothesize that compared to EU, the amplitude of clock gene~     expression in SAT measured over 24hrs will be attenuated following short-term HF-OF. This~     pilot project will serve as a launch point for designing future studies into the effects of~     diet and exercise on the circadian control of metabolism in adipose tissue depots as well as~     other tissues (e.g. muscle).~   "
57921|NCT02808780|"~     The purpose of this study is to compare the incidence of lymphoma in adult participants with~     moderate-to-severe ulcerative colitis who are treated with Simponi versus those treated with~     thiopurines.~   "
57922|NCT02808767|"~     This study evaluates the efficacy of Prasugrel and Ticagrelor in the treatment of acute~     myocardial infarction.~   "
57923|NCT02808754|"~     This is a randomized controlled trial designed to test an intervention (Remote ischemic~     preconditioning) in patients undergoing carotid endarterectomy (CEA) for carotid artery~     stenosis (CAS). The outcomes of interest include neurocognitive function, cardiac~     complications, and biomarkers of brain ischemia.~   "
57869|NCT02809469|"~     Apixaban is an anticoagulant which is increasingly being used to prevent stroke in atrial~     fibrillation (AF). Phase III clinical trials have demonstrated that apixaban is efficacious~     and safe for the overall AF population; however, patients older than age 85, with creatinine~     clearance <40mL/min, or who weighed <50kg were poorly represented in these trials, yet they~     are commonly seen in real-world clinical scenarios. Advanced age, poor renal function, and~     low body weight are all associated with elevated drug levels, and elevated drug levels are~     associated with an increased risk of bleeding. Therefore, clinicians are concerned about the~     risk of bleeding and are unsure of how best to treat this patient population. Although other~     anticoagulants are available, apixaban is attractive because it has a low rate of bleeding,~     low dependence on the kidneys for clearance, and does not require frequent ongoing monitoring~     and dose adjustment. This study will include patients taking apixaban who were not~     well-represented in phase III trials - those with age >85, creatinine clearance <40mL/min, or~     weight <50kg - who are also at increased risk of having elevated drug levels due to these~     clinical characteristics. Participants will have apixaban levels measured, and those with~     persistently elevated levels will have their dose reduced. Drug levels will be measured again~     after dose reduction to determine if the levels are reduced without becoming dangerously low.~   "
57870|NCT02809456|"~     This project will test the effect of nicorandil to mitigate the lung damage that can occur as~     a side effect of radiation therapy for lung cancer. Thousands of veterans develop lung cancer~     every year, and are treated by radiation therapy. Studies of lung radiation injury in~     laboratory animals show that with nicorandil, investigators can significantly reduce the~     severity of lung fibrosis and heart toxicity.1,2 Nicorandil is FDA approved and in common use~     for treatment of angina. These studies will advance that work to human use. Successful~     mitigation of lung radiation damage and heart toxicity will improve the quality of life in~     veterans and non-veterans who are treated for lung cancer by radiation, and may also improve~     cure rates of radiation therapy for lung cancer.~   "
57871|NCT02809443|"~     The clinical trial will assess the safety, tolerability, and immunogenicity of GLS-5700.~     GLS-5700 is a synthetic DNA plasmid vaccine against the Zika virus. ZIKA-001 is the first in~     man clinical trial of this vaccine which encodes for the premembrane-membrane and envelope~     regions of Zika virus.~      Zika virus, first discovered in the Zika forest in 1947, has caused a large epidemic in South~     America, Central America, and the Caribbean islands commencing in late 2014 or early 2015.~     Zika virus can cause significant neurologic disease to include Guillain Barre Syndrome in~     adults and microcephaly and other birth defects among children born to mothers who are~     infected during pregnancy. At present no vaccines or treatments have been approved for Zika~     virus infection.~   "
57872|NCT02809430|"~     Obstructive sleep apnea (OSA) is associated with impaired stroke recovery. Treatment with~     continuous positive airway pressure (CPAP) may prevent this but is limited by poor adherence.~     In this study, the investigators will enroll eligible stroke patients undergoing inpatient~     rehabilitation into an intensive CPAP adherence protocol (iCAP) with an aim to increase~     tolerance and adherence to auto-titrating CPAP (APAP). The iCAP will include patient~     education and encouragement, device adjustments, close monitoring of adherence and a 3-night~     run-in period of APAP to identify those patients who 1. have OSA and 2. have APAP tolerance.~     If both criteria are met, APAP treatment with iCAP will continue during the rehabilitation~     stay and over a 3-month period. The goal of the intervention is to achieve 50% of subjects~     meeting APAP adherence (an average ≥ 4 hours per night) over the 3-month treatment period.~     The investigators will evaluate if demographic, co-morbid or stroke-specific factors predict~     APAP adherence and assess the relationship between APAP adherence and neurological recovery.~     Successful completion of the project will establish the feasibility of a definitive trial~     assessing the ability of APAP to improve stroke recovery in the short-term and reduce the~     risk of recurrent stroke in the long-term.~   "
57873|NCT02809417|"~     This project is associating partners from the public area (university hospital of Nice, Nice~     university) and the private area (Agfa Health Care, Radhuis, Domicalis) to create a unique~     medico-psycho-social shared record.~      The purpose of this project is to significantly improve coordination of care, especially~     between hospital and home. We can expect a significant improvement in the patient's living~     conditions, improving its management, its security and ultimately, lower health care costs.~   "
57874|NCT02809404|"~     Everolimus shows a large interpatient variability with fixed dose administration. These very~     different exposure levels between individuals can result in supratherapeutic or~     subtherapeutic exposure levels and consequently in over- or undertreatment, respectively.~     Dose individualization based on the measured drug concentration could theoretically result in~     less toxicity and more efficacy.~      Nowadays everolimus exposure is determined by everolimus concentration in whole blood.~     Therefore, a vena puncture is always necessary. This is invasive and requires patients to~     come to the hospital. It would be convenient for patients to have their everolimus blood~     concentration determined by dried blood spot (DBS) analysis. With DBS only a single drop of~     blood from the finger is necessary, which can be done at home and sent by regular mail for~     analysis. Previous studies have shown the feasibility of this approach. In patients with~     cancer treated with everolimus 10mg once daily, the correlation between everolimus DBS~     concentrations and whole blood concentration is yet unknown. Therefore, the investigators~     want to determine the everolimus concentration collected with DBS from a finger prick with~     everolimus concentration from whole blood and everolimus concentration collected with DBS~     from whole blood.~      In addition, possibly a relatively high everolimus concentration in saliva could be~     correlated with the incidence and severity of oral mucositis. Determination of drug~     concentration in saliva has also been proven to be feasible before.~      Therefore, in this study the investigators want to determine whether the everolimus~     concentration in saliva correlates with the incidence of oral mucositis and how everolimus~     concentration in saliva correlates with everolimus concentration in whole blood.~   "
57875|NCT02809391|"~     The purpose of this study is to increase clinical knowledge of the relationship between~     increased plantar sensory information and orthotics in a Parkinsonian gait. The objectives of~     this study are to determine if orthotics, with and without a textured top cover, can alter~     muscle activation, gait parameters, balance, functional mobility, and decrease fall risks in~     Parkinson's participants.~   "
57924|NCT02808741|"~     Single dose comparison of liquid and solid formulation, followed by study of effect of high~     fat breakfast.~      Evaluation of multiple dose pharmacokinetics and tolerability~   "
57876|NCT02809378|"~     The incidence of postoperative nausea and vomiting (PONV) after thyroidectomy have been shown~     to be relatively high compared other surgeries, with a reported incidence 65-75 %. PONV may~     increase patient discomfort, delay patient discharge, and increase the cost of patient care,~     the risk of postoperative bleeding which may potentially cause airway obstruction.~      It is reported that the maintenance of anesthesia with propofol-remifentanil or~     sevoflurane-propofol-remifentanil decreased the incidence of PONV compared sevoflurane alone,~     but failed to demonstrate the decreased incidence of PONV in 6-24 hr postoperative period in~     patients undergoing thyroidectomy. Administration of Palonosetron, newly developed 5-HT3~     antagonists with long half life (48 hrs) may decrease the incidence of PONV particularly~     during this period.~      The purpose of this study was to evaluate and compare the incidence of PONV after~     thyroidectomy with three different anesthetic methods, sevoflurane or~     sevoflurane-propofol-remifentanil or sevoflurane-propofol-remifentanil-palonosetron in woman~     patients.~   "
57877|NCT02809365|"~     This is a randomized controlled study in type 2 diabetic patients who are presently~     uncontrolled on at least 2 injections of insulin daily with an A1C >7.5 % and <10%. Patients~     need to be stabilized on their MDI for 1 week then randomized to either SBGM or FreeStyle~     Libre for 10 weeks.~   "
57878|NCT02809352|"~     Cervical cancer is due to a persistent infection with a group of viruses known as high-risk~     Human Papillomaviruses (hrHPV). Viral DNA can be easily detected in a cervical sample by a~     procedure called 'HPV testing', which can be used as a relevant screening test. A pilot~     screening program called START-HPV has been set up in the Ardennes, a French administrative~     area localized in the North of France, with HPV testing as a primary screening test.This~     observational study aimed to evaluate hrHPV genotypes repartition in the population who~     participate in the START-HPV screening program. This study will allow a better knowledge of~     hrHPV infection epidemiology in a screened population.~   "
57879|NCT02809339|"~     Ovarian cancer is a major cause of cancer related death among women. The disease is usually~     advanced at diagnosis, because specialist referral is delayed due to vague nature of~     presenting symptoms. Primary treatment is successful, but most patients experience~     recurrence. Complaints due to disease and therapy overlap. Furthermore treatment schedules~     are similar in response rate and survival rates. Toxicity of therapy as scored by the~     physician is best documented, but varies depending on type of chemotherapy. Moreover most~     knowledge is acquired in clinical trials and not in daily practice. Patient reported outcome~     (PROs) concerning effects on symptoms, velocity of relief and quality of life (QoL) by the~     different regimens is sparce. Also it is unknown which symptoms are best relieved. Most~     trials take into account progression or survival as primary endpoint but not often symptom~     relief, which is especially important for patients with recurrent disease, without no chance~     of cure anymore. Knowledge on rating of problems and needs of patients with recurrent ovarian~     cancer (ROC) to support them in the course of their disease is needed to come to an evidence~     based and patient centered treatment of choice together with the patient. Physicians most~     frequently use the Common Toxicity Criteria (CTC) scale for grading of side effects of~     treatment, but discrepancies with patient experiences is high. Routine collection of PROs may~     therefore improve patient expectations and management. In this project the investigators~     intend to augment knowledge by PROs of different chemotherapy schedules for recurrent ovarian~     cancer in order to improve shared decision making with the physician.~      Objective: primary objective of this project is to explore the relief of symptoms due to ROC,~     the speed with which this occurs by different chemotherapy schedules and development of~     complaints due to the regimen of chemotherapy. Secondary the investigators intend (1) to~     assess preferential symptom relief by patients, (2) to correlate toxicity and symptoms of~     disease to tumor assessed response to chemotherapy and (3) to correlate symptom relief by~     psychosocial context.~   "
57880|NCT02809326|"~     This trial will evaluate the efficacy and efficiency of Trauma Management Therapy (TMT;~     Frueh, Turner, Beidel, 1996; Beidel, Frueh, Uhde, under preparation), which combines~     individual virtual reality (VR) assisted exposure therapy with group social and emotional~     rehabilitation skills training (will be superior to a treatment consisting of the same VR-~     exposure and group psychoeducational group therapy. TMT will be conducted in traditional~     17-week format, and a 3-week intensive treatment format. Outcome will be assessed using~     relevant clinical, process, and cost outcomes. Additionally, investigators will assess the~     potential of olfactory stimulation as a trigger for PTSD symptoms of intrusive thoughts and~     re-experiencing. Therefore, this proposal will integrate clinical and neurobiological~     assessment studies designed to understand the role of these factors in the etiology,~     maintenance, and treatment of PTSD.~   "
57881|NCT02809313|"~     The aim of this randomized placebo- controlled clinical trial is to evaluate the effects of~     Lactobacillus rhamnosus SP1- containing probiotic sachet as an adjunct to scaling and root~     planning (SRP). Material and methods: Thirty six gingivitis patients will be recruited and~     monitored clinically and microbiologically at baseline and 3-6 months after therapy. All~     patients will receive scaling and periodontal treatment and randomly will be assigned over an~     experimental (SRP + probiotic, n=18) or control (SRP + placebo, n=18) group. The sachet will~     be used once per day during 3 months.~   "
57882|NCT02809300|"~     The main objective is to evaluate the prevalence of anti-phospholipid antibodies (APLA) in~     patients with ankylosing spondylitis (AS).~      The secondary objectives are: (1) To determine whether the presence of these antibodies is~     symptomatic (thrombosis or not); (2) Identify a possible relationship between the presence of~     APLA and a particular form of SA (axial or peripheral); (3) To determine whether the presence~     of APLA is more frequent in patients receiving anti-tumor necrosis factor (TNF) alpha~     therapy.~   "
57883|NCT02809287|"~     Since the first report of laparoscopic resection of a benign hepatic tumor by Professor H.~     Reith in 1991, the laparoscope has been widely used in liver disease. Based on its advantages~     in laparoscopic vision and amplification, laparoscopic hepatectomy (LH) has been well~     recognized globally. Generally speaking, for lesions located in the left, front or lower part~     of the liver, corresponding to Couinaud segments II, III, IVb, V and VI, an LH surgery is~     recommended; however, for lesions located in segments VII and VIII, the surgery is high~     technically difficult due to poor exposure. Therefore,the investigators employ the left~     lateral position plus jackknife position to better expose lesions in these segments, hoping~     to reduce surgical time and bleeding in LH.~   "
57884|NCT02809274|"~     Iron deficiency is a known feature of PV, occurs because of accelerated erythropoiesis,~     gastrointestinal blood loss and phlebotomy. Incidence and effect of iron deficiency in these~     patients is not well characterized. The study will assess the incidence of iron deficiency at~     diagnosis and during the course of PV, assess effect of iron deficiency on patient symptoms~     and its correlation with disease features.~      This is a multicenter, non-interventional, non-randomized, prospective, observational study~     in an adult population (patients >18 years old) of patients who have been diagnosed with PV~     and are being followed in either community or academic medical centers in Israel.~   "
58375|NCT02802813|"~     This study aims to determine whether a 14 day course of 0.5 mg/kg/day primaquine can~     eliminate subclinical P. vivax infections detected by high volume ultra-sensitive PCR (uPCR).~   "
57885|NCT02809261|"~     Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with~     involving compression of the median nerve in the carpal tunnel. Rather than other progressive~     disease, CTS is characterized by remission and recurrence. Although many conservative~     managements of CTS, the effectiveness of these methods is insignificant or only persist for a~     short duration. Recently, the ultrasound-guided perineural injection with 5% dextrose was~     widely used for entrapment neuropathy with positive benefit. However, current studies have~     not entirely proved the effects of perineural injection on peripheral neuropathy because~     these studies enrolled small number of patients and lacked controlled design. The~     investigators design a randomized, double-blind, controlled trail to assess the effect after~     ultrasound-guided perineural injection with 5% dextrose in patients with CTS.~   "
57886|NCT02809248|"~     The aim of the study is to choose an optimal stent and to get further knowledge about the~     mechanisms of the engraftment of a stent.~      The occurrence of a hyperplasia of neointima can be minimized by application of a coated~     stent and a concurrent safety four weekly dual thrombocytes therapy~   "
57887|NCT02809235|"~     In this proof of concept study, the investigators aim to determine if supplementation with~     coconut oil causes an increase in cholecystokinin and cholecystokinin receptor expression in~     the airway smooth muscle of lean asthmatics, and whether these changes correlate with changes~     in airway stiffness (estimated by bronchodilator reversibility, airway reactivity, and airway~     resistance) or symptom control.~      The investigators propose a 5 week, single center trial in 20 lean patients with mild asthma~     (not taking inhaled corticosteroids) aged 18 and older. Subjects will supplement their usual~     diets with 3 tablespoons of coconut oil, a commercially available oil with high dodecanoic~     acid content, for 3 weeks. To quantify changes in airway smooth muscle cholecystokinin and~     cholecystokinin-receptor expression, each subject will undergo bronchoscopy with~     endobronchial biopsies before and after coconut oil ingestion.~      For the secondary analysis, subjects will also complete spirometry with bronchodilator~     testing, methacholine challenge, body plethysmography, and an Asthma Control Questionnaire~     (ACQ) before and after the dietary intervention. This information will be used to compare the~     changes in airway smooth muscle cholecystokinin and cholecystokinin receptor expression to~     changes in bronchodilator reversibility, airway reactivity, airway resistance, and symptom~     control.~      In the exploratory aims, the investigators will correlate the changes in airway smooth muscle~     cholecystokinin and cholecystokinin receptor expression with changes in FEV1 and peak flow~     measurements.~      The investigators therefore hope to elucidate information about the mechanistic role of~     cholecystokinin in airway smooth muscle stiffness and contraction.~   "
57888|NCT02809222|"~     Myelodysplastic syndromes (MDS) is a group of heterogeneous diseases characterised by the~     clonal evolution of dysplastic hematopoietic stem cells. This evolution is associated with~     accumulation of cytogenetic mutations which leads to acute myeloid leukaemia (AML). Evolution~     of MDS is also associated with increase of reactive oxygen species (ROS). The increase of ROS~     is associated with accumulation of cytogenetic mutations. Ascorbic acid (AA) is an actor of~     the regulation of the oxidative metabolism in the human body.~      Studies showed that supplementation with AA can change the proliferation status of MDS cells.~     Adjuvant treatment with AA is associated with a beneficial effect on the evolution of MDS and~     AML. The present study aim at describing the variations of plasmatic ascorbic acid~     concentrations between healthy volunteers and patients with myelodysplastic syndromes~     advanced in their treatment or recently diagnosed during a follow-up of 12 months.~   "
57889|NCT02809196|"~     The overall objective is to examine if participating in an SMS-transmitted health educational~     program targeting a cluster of dietary factors over a period of weeks during the years of~     adolescence can induce durable changes towards more healthful dietary habits. The~     investigators will examine if impact is reinforced by asking a friend of the participant to~     also participate; if impact is reinforced by asking the mother of the participant to also~     participate; and if impact is reinforced when the SMS-transmitted health promotion program is~     designed to target a specific dietary factor only - decided upon from participants' reporting~     of their dietary habits at the beginning of the program - rather than to simultaneously~     target a cluster of dietary issues uniform for all participants.~   "
57890|NCT02809183|"~     This is a double-blind, placebo-controlled, parallel-design, 6-arm, fixed dose study. The~     study will enroll approximately 130 adult male and female subjects with Stage 3 or 4 chronic~     kidney disease and low serum bicarbonate levels. The study will be conducted in two parts. In~     Part 1 study drug dosing (TRC101 or placebo) will continue for 14 days twice daily. In Part 2~     study drug dosing (TRC101 or placebo) will continue for 14 days once daily.~      The maximum study duration is anticipated to be up to 42 days.~   "
57891|NCT02809170|"~     Mitochondrial diseases occur due to inadequate energy production. In addition, nitric oxide~     (NO) deficiency occurs in mitochondrial diseases. The endothelial layer of blood vessels~     functions in maintaining blood vessels patency through producing NO which relaxes vascular~     smooth muscles and therefore maintains the patency of blood vessels and adequate blood~     perfusion. In mitochondrial diseases, endothelial cells fail to perform their normal function~     in maintaining the patency of blood vessels (endothelial dysfunction) because of the~     inability to produce enough NO. Endothelial dysfunction results in decreased blood perfusion~     in different organs which can contribute to the complications seen in mitochondrial diseases.~     The amino acids arginine and citrulline act as NO precursors and can increase NO production.~     In this study we hypothesize that due to the inability to produce enough NO patients with~     mitochondrial diseases have endothelial dysfunction that will improve after arginine or~     citrulline supplementation. The investigators will assess endothelial function using~     peripheral arterial tonometry before and after arginine or citrulline supplementation. The~     investigators expect that arginine and citrulline supplementation will improve endothelium~     function. This will support the therapeutic use of arginine and citrulline in mitochondrial~     diseases.~   "
57925|NCT02808728|"~     Does the use of periarticular Exparel in total knee arthroplasty prove to more effectively~     manage post operative pain control than another local analgesic, Ropivacaine, when both are~     used as part of a multimodal pain management approach?~      The investigators hypothesize that Exparel, a bupivacaine liposomal injectable suspension,~     will improve total knee arthroplasty postoperative pain with significant improvement of early~     function outcomes.~   "
58419|NCT02802241|"~     The purpose of this study is to investigate placebo effects and peppermint oil in Irritable~     Bowel Syndrome.~   "
57892|NCT02809157|"~     Coronary artery disease (CAD) is a very common cause of heart failure affecting millions of~     people worldwide, which is caused by build-up of plaque inside arteries of the heart.~     Build-up of plaque eventually impacts the blood supply to the heart. In medicine, techniques~     (invasive or non-invasive) such as coronary angiography, intravascular ultrasound, computed~     tomography, magnetic resonance imaging, positron emission tomography and transthoracic~     echocardiography can be used to diagnose CAD.~      The investigators aim to study Coronary Artery Disease significance with the combination of~     computed tomography angiography (CTA), and computational fluid dynamics (CFD) methods. CTA is~     a non-invasive technique to visualize arterial vessels, which uses computer-processed x-rays.~     Computational Fluid Dynamics employs digital computers and numerical methods to solve complex~     flow patterns inside arterial vessels. Combining these two methods, the investigators are~     able to provide detailed blood flow information and mechanical stress distributions on the~     vessels. This study therefore, aims to propose a non-invasive methodology to assess the~     significance of CAD.~   "
57893|NCT02809144|"~     Interscalene block has been the traditional regional anesthesia for shoulder surgery and~     postoperative pain. However, the risk of phrenic nerve palsy and irreversible nerve injury~     have encouraged search for alternative methods.~   "
57894|NCT02809131|"~     The number of cardiac implantable electronic devices (CIEDs) implanted each year has grown~     rapidly over the past two decades. CIED infections, defined as infections involving the~     generator implant site (pocket) and/or intravascular leads, have become increasingly~     prevalent, with the rate of growth in infections outpacing that of CIED procedures. The odds~     of both short term and long term mortality are at least doubled in patients who suffer CIED~     infections, and long term survival is particularly poor in women. Optimal strategies to~     prevent CIED infections in high-risk patients are largely unproven. However, recent~     observational studies of an antibiotic-coated envelope implanted at the time of CIED~     procedure have shown that this strategy is associated with a low incidence of CIED~     infections. Other interventions to prevent CIED infections, including the use of antibiotic~     irrigant used to wash the pocket during implantation and postoperative oral antibiotics, are~     commonly used but not supported by rigorous controlled studies. The Specific Aim of this~     study is to test the hypothesis that the use of the antibacterial envelope alone is~     noninferior to a strategy using the antibacterial envelope and intraoperative antibacterial~     irrigant and postoperative oral antibiotics for the reduction of cardiac implantable device~     infections in patients with ≥2 risk factors for infection.~   "
57895|NCT02809118|"~     The primary objective of the trial is the confirmation of the efficacy of AM-111 in the~     recovery of severe to profound idiopathic sudden sensorineural hearing loss (ISSNHL).~   "
57896|NCT02809105|"~     The objective of this study is to verify the efficacy and investigate the safety of the study~     drug when ASP0456 is administered orally for 4 weeks and 52 weeks.~   "
57897|NCT02809092|"~     Relapsed acute myeloblastic leukemia (AML) requires remission prior to allogeneic~     Hematopoietic Stem Cell Transplant (HSCT) for optimal survival, but is a disease with poor~     response to chemotherapy. Human leukocyte antigen (HLA) haploidentical, Natural killer (NK)~     enriched peripheral blood cell infusions have shown safety in patients with poor prognosis~     AML. Though not powered for such an assessment, this trial showed a promising but not~     statistically significant trend in remission rate. NK cell therapy was limited by small~     numbers of NK cells attainable through leukapheresis. We have now demonstrated that large~     numbers of NK cells can be propagated ex vivo from a small volume blood draw, obviating the~     need for donor leukapheresis. The purpose of this trial is to determine the feasibility and~     maximum tolerated dose of expanded NK cells and estimate the toxicity of treating~     relapsed/refractory AML with fludarabine + high-dose cytarabine + G-CSF (FLAG) chemotherapy~     followed by haploidentical expanded natural killer (NK) cells.~      The first NK cell dosing cohort will be well below the currently-established safe dose of~     pheresis-derived NK cells, as expanded NK cells may have increased toxicity because of their~     activated phenotype. In order to avoid accruing patients at suboptimal doses, a dose~     escalation schema based on the principles of an accelerated titration design is used in this~     study to allow expeditious advancement up to the current safe dose of NK cells.~   "
57898|NCT02809079|"~     Neuromyelitis optica (NMO) is an autoimmune inflammatory demyelinating disease of the central~     nervous system that leads to blindness and paralysis. Since disability accrues incrementally~     related to attacks, attack prevention with immunosuppressive therapy is the mainstay of~     preventing disability. However, there is no standard immunosuppressive treatment strategy for~     NMO relapse prevention. In a previous study, the investigators provided evidence supporting~     the use of azathioprine plus a low dose corticosteroid as an effective strategy which is~     associated with a reduction in the risk of relapse in Chinese patients with NMO, but~     azathioprine has bone marrow suppression and other side effects. Mycophenolate mofetil (MMF)~     is a new immunosuppressant with rapid onset, fewer side effects and other advantages. In~     recent years, MMF has been used in different immune-related neurological diseases; some~     literature shown the possible efficacy of MMF in NMO treatment.~      In this research, a multi-center (Third Affiliated Hospital of Sun Yat-sen University,~     Zhongshan Ophthalmic Centre of Sun Yat-sen University, Nangfang Hospital of Southern Medical~     University) study will carry out to evaluate the efficacy and safety of mycophenolate mofetil~     therapy in NMO spectrum disorders.~   "
57899|NCT02809066|"~     This study was planned and conducted to investigate effect of adequate calcium intake on~     Premenstrual Syndrome (PMS) symptoms in women with PMS who have inadequate calcium intake.~   "
57900|NCT02809053|"~     This is a Randomized, Double-blind, Multi-center, Multi-national Trial to Evaluate the~     statistical equivalence of efficacy, safety and immunogenicity of SAIT101 Versus Rituximab as~     a First-line Immunotherapy Treatment in asymptomatic patients with Low Tumor Burden~     Follicular Lymphoma.~   "
57901|NCT02809040|"~     Hypertensive heart disease (HHD) is a heart condition that is caused by chronic exposure to~     high blood pressure. In patients with HHD, abnormalities in the way heart muscle relaxes and~     how heart chambers passively fill with blood (diastolic dysfunction) can occur that may be~     detected on echocardiography (echo), which is a standard clinical method to examine heart~     structure and function using reflected sound waves. Investigators propose to develop a~     digital auscultation system or electronic stethoscope based on wireless sensor node~     technique. Investigators hypothesize that the heart sounds measurements detected by~     electronic stethoscope can be used to detect heart diastolic dysfunction in HHD .~   "
57903|NCT02809014|"~     The literature recognizes that fluoride is the most widely used and studied means for dental~     remineralization. The use of fluoride toothpaste in brushing is considered more rational~     method for the prevention of caries. However, the current challenge of toothpaste is the~     substantivity, so new compounds have been introduced into these formulations. This study aims~     to evaluate the in vivo effect of fluoride dentifrice containing a natural product -~     hydrocolloid tara gum - in fluoride retention in saliva and dental plaque. A study of the~     clinical and laboratory type, crossover, double-blind, randomized will be held. After sample~     calculation, the total of 12 individuals aged between 18 and 35 years old, healthy, decayed,~     missing, and filled teeth index less than 6 and residents in brazilian northeast capital will~     be part of the sample. Fluoride bioavailability will be evaluated in the biofilm and saliva~     after the use of fluoridated weekly. The biofilm will be assessed on 1h and 12 h after~     brushing; and unstimulated saliva in times of 3, 15, 30, 45, 60 minutes and 12 hours after.~     It will be 4 toothpastes: 1100ppm F- with hydrocolloid; F- 550ppm with hydrocolloid; 1100ppm~     F- without hydrocolloid; Without fluoride with hydrocolloid. Between weeks of use, brushing~     will be extended washout (without fluoride and no hydrocolloid) to avoid carryover effect.~     inferential data analysis will be carried out, considering the amount of alpha <0.05. So~     knowing that caries is a dynamic process, the largest fluoride retention in the oral fluids~     promoted by the hydrocolloid may have important impact on Des-Re process and in the control~     of dental caries.~   "
57904|NCT02809001|"~     The purpose of this study is to evaluate whether autologous fat grafting is safe and/or~     effective to prevent expanded skin from expansion failure.~   "
57905|NCT02808988|"~     The investigators evaluated the effect of initial periodontal treatment on clinical findings~     and receptor activator of Nuclear Factor-kappa B ligand (RANKL) and osteoprotegerin (OPG) in~     gingival crevicular fluid (GCF) of patients with osteoporosis under bisphosphonate therapy~     within 12 months' follow-up. Clinical recordings and GCF were obtained from postmenopausal~     women; with chronic periodontitis and osteoporosis (Group A, n=13), with chronic~     periodontitis and no osteoporosis (Group B, n=12), without chronic periodontitis and~     osteoporosis (Group C, n=12), systemically and periodontally healthy controls (Group D, n=10)~     at the baseline. Recordings were repeated at the 1st, 6th and 12th months in Group A, B and~     C. RANKL and OPG values were measured by enzyme-linked immunosorbent assays.~   "
57906|NCT02808975|"~     The objective of this study is to assess the safety and efficacy of adalimumab prior to~     surgery in subjects with moderate to severe Hidradenitis Suppurativa (HS) who are surgical~     candidates.~   "
57907|NCT02808962|"~     The procedure is supposed to ablate the sacral lateral branches that form the medial cluneal~     nerves (MCN). The anatomy of the sacral lateral branches is such that, in addition to~     innervating the SIJ, distal branches of these nerves also innervate the skin over the buttock~     through MCN (12,13). SLB blocks (usually with 0.5 ml of 1% Lidocaine or 0.5% Bupivacaine) are~     performed proximal to the origin of both the nerves to the SIJ and the cutaneous branches.~     Therefore, a technically accurate block should anesthetize not only the SIJ but also the skin~     of the buttock regardless of the patient symptoms. Hypoesthesia of the buttock would,~     therefore, be a quality-assurance sign that the block has been performed in a technically~     correct fashion. Similarly, if the target nerves have been accurately ablated by RFA~     hypoesthesia of the buttock should ensue, as an expected effect of the procedure.~   "
57908|NCT02808949|"~     Phase 1 PK Study of the Dapivirine Vaginal Ring in Lactating Women.~   "
57909|NCT02808936|"~     The investigators attempt to investigate the organ protective effect of remote ischemic~     conditioning in patients undergoing non-cardiac surgery with history of ischemic heart~     disease.~   "
57910|NCT02808923|"~     The purpose of this study to to compare the long-term effects of foam rolling in comparison~     to static stretching and a control group on hamstring flexibility. The investigators~     hypothesize that participants in the foam rolling and static stretching group will~     demonstrate increased flexibility to the control group, but will a difference will not be~     observed between the foam rolling and static stretching groups.~   "
57911|NCT02808910|"~     This study will investigate whether small changes (nudges) made in a cafeteria, where~     participants eat for 4 weeks, can improve their food behavior and health during the 4 weeks,~     and 6 weeks and 6 months after their stay. Half the participants will be exposed to one of~     four types of nudges (focused on reducing salt intake, increasing vegetable intake, reducing~     portion size, and a combination of these nudges), and half of the participants will eat in~     the cafeteria as it is currently, without modifications.~   "
57912|NCT02808897|"~     The purpose of this study is to assess the effectiveness of the PleuraFlow® Active Clearance~     Technology® (ACT) in reducing the rate of postoperative atrial fibrillation (POAF) among post~     cardiac surgery patients and to evaluate the impact of ACT on other complications, such as~     retained blood syndrome (RBS), a composite endpoint including re-exploration for bleeding or~     tamponade, and interventions for hemothorax, pericardial or pleural effusion.~   "
57913|NCT02808884|"~     The investigators have developed an assay that can sensitively and specifically detect DNA~     mutations circulating in human plasma that may be indicators of the presence of a solid~     tumor. This study is a pilot study to measure positive and negative predictive values of this~     assay as an indicator of the presence of a tumor in normal subjects~   "
57914|NCT02808871|"~     The purpose of this study is to to assess the safety and tolerability of pirfenidone 2403~     mg/day for the treatment of RA-associated interstitial lung disease.~   "
57915|NCT02808858|"~     Epidemiological data collection of adult patients affected by myelodysplastic syndrome (MDS)~     newly diagnosed.~   "
57916|NCT02808845|"~     The purpose of this study is to investigate the association between pre-existing~     microalbuminuria and contrast-induced acute kidney injury (CIAKI) following coronary~     angiography (CAG).~   "
57917|NCT02808832|"~     The purpose of this study is to develop, deliver and evaluate a provider intervention for~     mothers and their children to encourage receipt of the human papillomavirus (HPV) vaccine in~     the children and appropriate cervical cancer screening in the mothers.~   "
57918|NCT02808819|"~     The purpose of this study is to continue to characterize the safety profile of benralizumab~     administration and monitor the pharmacodynamic activity of the drug in those asthma patients~     who remain on treatment for at least 16 weeks and not more than 40 weeks in the predecessor~     study D3250C00021 (BORA).~   "
57926|NCT02808715|"~     Chinese male subjects will be invited to participate in a research study of brown fat, a~     special tissue in the body that is designed to burn energy to make heat. The objective is to~     learn the importance of a gene called PRDM-16 for the function of brown fat. Subjects were~     selected as a possible subject in this study because they fulfil the age and weight criteria.~      500 subjects from the Singhealth Investigational Medicine Unit healthy volunteer database~     will be recruited over a period of 2 years. All of the subjects will have their PRDM-16 gene~     sequenced. The objective is to identify subjects with mutations, or changes, in their PRDM-16~     gene. About 12 subjects with PRDM-16 mutations are expected to be identified.~      Samples of blood obtained during the course of this study will be stored and analysed only~     for the purposes of this study for a period not exceeding 2 years, and will be destroyed~     after completion of the study, unless subject is agreeable to donate the samples to the~     National Heart Centre Singapore for continuous storage for future studies that are approved~     by the institutional review board..~   "
57927|NCT02808702|"~     The purpose of this study is to determine whether neuroimaging-based markers of maladaptive~     self-focused processing are better predictors of treatment response to cognitive-behavioral~     therapy than behavioral markers.~   "
57928|NCT02808689|"~     This is a pilot, proof of concept, early stage study. The study goal is to determine whether~     the Functional Medicine approach to the treatment of moderate to severe persistent asthma~     enhances standard guideline-based care with respect to asthma outcomes.~   "
57929|NCT02808676|"~     The proposed SYNERGIC trial is uniquely designed to evaluate the effect of aerobic and~     progressive resistance training exercises, combined with cognitive training and Vitamin D3~     supplementation, in cognition and mobility in older adults with Mild Cognitive Impairment~     (MCI).~   "
57930|NCT02808663|"~     Severe alcoholic hepatitis, defined by a Maddrey discriminant function above 32, is~     associated with significant short-term mortality. In patients with liver disease, studies~     have shown alterations of intestinal bacterial flora and an increase in intestinal~     permeability leading to bacterial translocation across the intestinal barrier. The mechanism~     involved may be an activation of intestinal macrophages with a local release of cytokines~     like interleukin-8 (IL-8).~      Calprotectin is a protein present in large amounts in the cytosol of neutrophils. Its~     presence in feces is related to neutrophil migration in intestinal lumen. Thus, fecal~     calprotectin may be used as a marker of intestinal inflammation. There is evidence that fecal~     calprotectin levels are increased in cirrhotic patients dependent on the severity of the~     disease. The predictive value of fecal calprotectin for the outcome of severe alcoholic~     hepatitis has never been evaluated.~      The main objective of this study was to determine if the initial level of fecal calprotectin~     and its variation after 7 days had a predictive value for the outcome of severe alcoholic~     hepatitis. Secondary objectives were to determine if fecal calprotectin concentration was~     correlated with blood concentration of Lipopolysaccharide (LPS) binding protein and~     predictive of infections.~   "
57931|NCT02808650|"~     This phase I trial studies the side effects and best dose of prexasertib in treating~     pediatric patients with solid tumors that have come back after a period of time during which~     the tumor could not be detected or does not respond to treatment. Checkpoint kinase 1~     inhibitor LY2606368 may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth.~   "
57932|NCT02808637|"~     This is a randomized double-blind controlled study and was performed to compare effects of~     rapid injection without aspiration and 10-second manual pressure before injection on pain~     severity and crying time in 4-6-month-old infants given the vaccine DTaP/IPV/Hib.~      The study population included all the infants presenting for DTaP/IPV/Hib to two family~     health centers between April and August in 2015. The study sample included 128 infants based~     on confidence interval of 95% and statistical power of 80%. The sample was divided into four~     groups; i.e. manual pressure, rapid injection without aspiration, manual pressure combined~     with rapid injection without aspiration and control groups. There were 32 infants in each~     group. Gender was adjusted in all groups. Stratified and block randomizations were used.~   "
57933|NCT02808624|"~     This study evaluates the prophylactic effect of exogenous L-CARNOSINE in Oxaliplatin induced~     peripheral neuropathy, Thus half of the patients will receive L-CARNOSINE with Oxaliplatin~     and the other half will not receive L-CARNOSINE with their chemotherapy (oxaliplatin),And~     then neuropathy together with some oxidative stress markers will be assessed at the end of~     treatment duration (three months) .~   "
57934|NCT02808611|"~     An extensive amount of studies indicate that conditioned pain modulation (CPM) test paradigms~     can be of use to evaluate the efficacy of the endogenous pain inhibition pathway in healthy~     controls and pain patients. A number of studies indicate that the autonomic nervous system~     (ANS) responds to painful stimulation by parasympathetic activity withdrawal and~     up-regulation of sympathetic activity (flight-or-fight mode), but it remains unknown whether~     these responses predict individual pain susceptibility or CPM efficacy and whether different~     pain modalities evoke different physiological stress responses, i.e. do individuals with low~     pain tolerance exhibit more vigorous ANS responses when subjected to controlled acute pain~     stimuli, and do high ANS responsiveness to pain coincide with altered psychophysical pain~     levels/CPM efficacy.~      This study aims to investigate the effect of ANS responsiveness on CPM paradigms and to~     investigate if an exogenous, pharmaceutically induced decrease in the sympathetic drive of~     the ANS will yield decreased CPM efficacy.~   "
57935|NCT02808598|"~     The purpose of this study is to test a program designed to increase African American and~     Hispanic American women's scientific literacy, knowledge of clinical trials, and to~     facilitate breast cancer clinical trial participation.~   "
57936|NCT02808585|"~     This study will be a sequential multiple-dose escalation study that will enroll (randomize~     and dose) approximately 28 subjects in four cohorts consisting of 3 active and 1 placebo in~     Cohort 1 and 6 active and 2 placebo in subsequent cohorts. Randomized subjects will receive a~     fixed weekly dose of study drug or placebo for a 4 week dosing period.~   "
57937|NCT02808572|"~     To evaluate the relationships between bone mineral metabolism markers (osteoprotegerin,~     fibroblast growth factor 23) at inclusion and the occurence of cardiovascular events during a~     3 year follow-up.~   "
58420|NCT02802228|"~     This placebo-controlled study will assess the safety and efficacy of a 90-day course of~     treatment with ifetroban for portal hypertension in cirrhotic patients~   "
57938|NCT02808559|"~     To quantify the severity of psoriasis in a consistent and clinically meaningful way is~     important in order to decide the therapeutic orientation to take for the patient. PASI~     (Psoriasis Area and Severity Index) scoring is recognised as gold standard for psoriasis~     assessment. The bodystudio ATBM (Automatic Total Body Mapping) is a high-tech system~     performing standardized photos from head to feet and from all angles, which allows to map the~     entire skin covering all the human body in a few minutes.The primary objective of this study~     would be to evaluate the ability of the bodystudio ATBM to calculate the PASI score of~     patients with psoriasis human body in a few minutes~   "
57939|NCT02808546|"~     The main purpose of this study is to investigate the region-specific cause of gallbladder~     stone incidence in Jeju Self-Governing Province, Korea.~   "
57940|NCT02808533|"~     Clozapine is the sole AP agent with superiority in treatment refractory schizophrenia, but it~     also is associated with the greatest risk of weight gain and other metabolic abnormalities.~     Topiramate, an anticonvulsant agent, possesses a weight-reducing effect. Furthermore, some~     studies have suggested that Topiramate may be associated with improvements in psychopathology~     in treatment refractory schizophrenia. Here the investigators propose to determine the role~     of topiramate for augmentation purposes (psychopathology) and as an adjunctive~     pharmacological intervention for weight loss in overweight/obese individuals with~     Ultra-Treatment Resistant Schizophrenia or Schizoaffective disorder taking clozapine.~   "
57941|NCT02808520|"~     Purpose of this study is to determine the influence of social factors on participation and~     activity among children and adolescents aged 10-18 years with hodgkin-lymphoma. Furthermore~     personal and treatment-related factors and their impact on participation will be explored.~   "
57942|NCT02808507|"~     The purpose of this study is to compare three strategies for finding TB cases in a rural~     Sub-Saharan African setting: 1) Screening all attendees of primary care clinics for TB; 2)~     Conducting household contact investigations of newly diagnosed TB cases; 3) Providing~     incentives to newly diagnosed TB cases and their contacts to promote contact screening for~     TB. For each intervention, investigators will measure comparative effectiveness in terms of~     cases identified as well as the cost-effectiveness and feasibility of implementation.~   "
57943|NCT02808494|"~     Sample Collection Study~   "
57944|NCT02808481|"~     Systemic sclerosis is a rare disease. The early cardiac disease affects 10% of patients~     sclérodemiques.~      Heart transplantation in the early cardiac involvement in systemic sclerosis is exceptional.~      we see patient data analysis with systemic sclerosis who used cardiac transplantation to~     understand the primitive cardiac damage associated with systemic sclerosis~   "
57945|NCT02808468|"~     The broad aim of this study is to develop and test a brief intervention that can be~     implemented in the immediate weeks following sexual assault to decrease likelihood of~     developing posttraumatic stress disorder (PTSD) or alcohol misuse. The first phase of the~     study will enroll 6 women to complete a brief, cognitive therapy protocol and provide~     feedback on the intervention (open trial). The second phase of the study will recruit 76~     women to complete either the intervention (38 women) or assessment only (38 women) to test~     the effects of the intervention on both PTSD symptoms and alcohol use behavior as compared to~     natural recovery following assault.~   "
57946|NCT02808455|"~     This was a randomized, 2-period, 2-treatment-sequence crossover study to determine the~     relative bioavailability of pacritinib following administration as a 400 mg oral dose of four~     100 mg pacritinib capsules and an 80 mg dose of an oral solution and to characterize the PK~     and major human metabolites of pacritinib.~   "
57947|NCT02808442|"~     This study aims at evaluating the safety and ability of UCART19 to induce molecular remission~     in pediatric patients with relapsed or refractory CD19-positive B-cell acute lymphoblastic~     leukemia (B-ALL) ahead of planned allogeneic hematopoietic stem cell transplantation~     (allo-HSCT).~   "
57948|NCT02808429|"~     This study will evaluate the safety, tolerability, dose response and efficacy of atacicept in~     patients with IgA nephropathy and persistent proteinuria. The study hypothesis is that~     treatment with atacicept will reduce proteinuria compared to placebo.~   "
57949|NCT02808416|"~     Cancer patients with brain metastases (BM) have poor prognosis. Current treatments produce~     limited efficacy. Recent advance in cancer immunotherapy has provided important new means to~     treat cancer patients at advanced stages. This study is designed to perform a clinical trial~     to treat advanced caner patients with brain metastases with personalized cellular vaccines.~     The patients will receive vaccines consisting of autologous tumor cells, tumor antigen pulsed~     DCs and peripheral blood mononuclear cells (PBMCs). Safety and efficacy will be observed in~     this study.~   "
57950|NCT02808403|"~     The purpose of this post-marketing survey is to obtain real-world information on the safety~     and effectiveness of evolocumab in Japan.~   "
57951|NCT02808390|"~     This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group~     study to evaluate the efficacy and safety of 2 doses of GED-0507-34-Levo in subjects with~     active, mild-to-moderate UC.~   "
57952|NCT02808377|"~     This is an RCT looking at the primary outcome of composite success following anterior repair~     with native tissue at 6, 12, 24 months in two arms. One arm will be randomised to have a soft~     silicone pessary inserted into the vagina post operatively for three weeks and the other will~     not.~   "
57953|NCT02808364|"~     The treatment option for recurrent glioblastoma is limited. Immune cell based therapy for~     glioblastoma has shown some efficacy. This study is designed to perform a personalized~     clinical trial by first analyzing the expression of tumor associated antigens in patients~     with recurrent glioblastoma and then immunizing the patients with personalized cellular~     vaccines including autologous tumor cells, antigen pulsed DCs and allogeneic peripheral blood~     mononuclear cells (PBMCs). Safety and efficacy will be observed in this study.~   "
57991|NCT02807857|"~     This low interventional study, whose unique intervention will be to measure the blood level~     of a biomarker called NT-proBNP in chronic heart failure patients daily followed-up by~     Primary Care Physicians (PCPs) in Europe, will assess if the cardiologist referral guided by~     NT-proBNP measurement in patients who are currently judged by PCPs as being stable, will lead~     to optimization of HF treatment, defined in adherence to treatment recommendations of the~     current European Society of Cardiology guidelines for the treatment of heart failure.~   "
57954|NCT02808351|"~     The number of cardiac angiography and percutaneous coronary interventions (PCI) has increased~     steadily in recent years. This has resulted in the increasing incidence of contrast-induced~     nephropathy (CIN). Major risk factors for CIN include older age, diabetes mellitus (DM),~     chronic kidney disease(CKD), the concurrent use of nephrotoxic drugs, hemodynamic~     instability, etc. Importantly, DM appears to act as a risk multiplier, meaning that in a~     patient with CKD it amplifies the risk of CIAKI.~      The aim of this multicenter prospective, randomized, controlled study is to evaluate whether~     berberine treatment during and after the perioperative period would reduce the risk of CIN in~     a high-risk population of patients with both DM and CKD undergoing coronary angiography or~     noncoronary angiography, and the influence of such potential benefit on short-term outcome.~   "
57955|NCT02808325|"~     It is the objective of the study to investigate the efficacy and safety of two different~     volume replacement regimens with gelatine solutions.~   "
57956|NCT02808312|"~     The primary objective of this study is to evaluate the single-dose pharmacokinetics of~     GS-9674 in adults with impaired hepatic function relative to matched, healthy controls with~     normal hepatic function.~   "
57957|NCT02808299|"~     The purpose of this study is to investigate the incidence of liver injury by statins in~     coronary heart disease (CHD) patients with history of hepatitis B virus (HBV) infection.~   "
57958|NCT02808286|"~     The aim of this project is to evaluate a hybrid emotion-focused treatment protocol,~     specifically developed for individuals who suffer from co-occurring chronic pain and clinical~     levels of anxiety and/or depressive symptoms.~      Specific questions relating to treatment outcome:~        1. Does a hybrid emotion-focused treatment lead to a decrease in comorbid emotional~          symptoms (pain-related fear, anxiety, depression)?~        2. Does a hybrid emotion-focused treatment lead to an increase in functional ability,~          improvement in work status and decrease in medication use?~        3. Does a hybrid emotion-focused treatment lead to better treatment effect on the above~          outcome variables compared to an active comparison group?~           Specific questions relating to the process of change:~        4. Are therapeutic effects of the hybrid emotion-focused treatment mediated by changes in~          proposed transdiagnostic emotion regulation process variables (worry, rumination,~          cognitive and behavioral avoidance, emotional suppression)?~   "
57959|NCT02808273|"~     A comparative study to reveal if the use of Bemiparine (Hibor) versus Enoxaparin (Clexane) as~     an antithrombotic agent, shows an advantage on the rate of thrombotic and haemorrhagic events~     in microsurgicals free flaps during head and neck reconstruction.~   "
57960|NCT02808260|"~     Atrial fibrillation (AF) often starts with short episodes of rapid irregular heartbeats that~     are only detected by implanted pacemakers or defibrillators. Usually people don't know that~     they have these episodes. Over time, these episodes can happen more often and last for longer~     periods. In some people, the heart eventually remains permanently in a fast irregular rhythm,~     known as atrial fibrillation. This condition can lead to strokes and blood clots. If~     physicians could detect atrial fibrillation at a very early stage they could treat people~     early and possibly prevent the condition from becoming permanent. People with implanted~     devices allow a unique opportunity to constantly monitor the heart rhythm so investigators~     can detect any irregularities immediately.~      Investigators don't know which people are at risk of developing short episodes of fast~     irregular heartbeats that can lead to atrial fibrillation. The purpose of this study is to~     find out if there are proteins or chemical changes in the blood that can predict the risk of~     developing atrial fibrillation. These chemical changes, also known as biomarkers, may also be~     able to give investigators other clues about atrial fibrillation.~   "
57961|NCT02808247|"~     This is a prospective, multicentric, randomized, open label Phase II trial investigating~     whether the oral angiogenesis inhibitor nintedanib, as compared to the intravenous cytotoxic~     compound ifosfamide, given for patients with advanced, inoperable and/or metastatic STS after~     failure of first line chemotherapy prolongs progression-free survival.~      The primary objective of the trial is to evaluate whether nintedanib given as second-line~     therapy for advanced, inoperable and/or metastatic STS prolongs progression-free survival~     when compared with ifosfamide.~      Secondary objectives are to evaluate the efficacy of nintedanib as compared to ifosfamide in~     terms of progression-free survival rate at 12 weeks, overall survival, objective response~     rate, patient benefit rate, response duration, total duration of treatment with nintedanib~     safety, Health related Quality of Life and Health Economics.~      Exploratory objectives include an analysis of putative predictive biomarkers for the~     anti-tumor effects of the investigational agent nintedanib.treatment.~   "
57962|NCT02808234|"~     The study is a prospective non-randomized multi-center feasibility clinical trial to~     establish the safety and efficacy of the Nucel® allograft tissue for use in lumbar interbody~     fusion procedures.~   "
57963|NCT02808221|"~     Heart failure (HF) is a serious chronic disease with frequent readmissions, some of which can~     be prevented by early action. The management of HF is complex: long, often difficult and~     costly. In France, nearly one million people suffer from HF and 120,000 new cases are~     diagnosed every year. With the aging population, this number will continue to evolve and~     become a real public health problem. Within 10 to 20 years ahead, WHO projects that heart~     failure in either the 3 most common diseases in industrialized countries.~      Investigators goals are to make an inventory of PRADO-IC project in terms of its~     effectiveness on readmission of patients with heart failure.~   "
57964|NCT02808208|"~     The aim of this phase 1 study is to determine the role of autologous adipose derived~     mesenchymal stem cells in the reduction of hemodialysis arteriovenous fistula failure when~     applied during the time of surgical creation.~   "
57965|NCT02808195|"~     The aims of the present study is to evaluate the effectiveness of Kinect-based upper limb~     motor rehabilitation system (ULMTS) program on motor performance and functional outcomes.~   "
57992|NCT02807844|"~     The purpose of this study of MCS110 with PDR001 is to characterize the safety, tolerability,~     pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of the combination of~     MCS110 with PDR001 in adult patients with solid tumors.~   "
58127|NCT02806076|"~     The purpose of this study is to prospectively compare the clinical outcomes (local tumor~     progression rate, technical success rate, complication rate) of no touch radiofrequency~     ablation (RFA) technique for Hepatocellular carcinoma (HCC) to those of conventional tumor~     puncture RFA technique.~   "
57966|NCT02808182|"~     Lipotoxicity-causing fatty acid overexposure and accretion in lean tissues leads to insulin~     resistance and impaired pancreatic β-cell function - the hallmarks of T2D - contributing to~     associated complications such as heart failure, kidney failure and microvascular diseases.~     Proper dietary fatty acid (DFA) storage in white adipose tissue (WAT) is now thought to~     prevent lean-tissue lipotoxicity. Using novel Positron-Emission Tomography (PET) and stable~     isotopic tracer methods which were developed in Sherbrooke, the investigator showed that WAT~     storage of DFA is impaired in people with pre-diabetes or T2D. The investigator also showed~     that this impairment is associated with greater cardiac DFA uptake, as well as subclinical~     left-ventricular systolic and diastolic dysfunction. Then, It has been found that modest~     weight loss in pre-diabetics, after a one-year lifestyle intervention, improved WAT DFA~     storage, curbed cardiac DFA uptake, and restored associated left-ventricular dysfunction. It~     has been also found that a 7-day low-saturated fat, low-calorie diet raised insulin~     sensitivity but did not restore WAT or cardiac DFA metabolism. Whether WAT DFA storage~     directly impacts cardiac DFA uptake is not known. Importantly, the investigator recently~     uncovered marked sex-specific differences in WAT DFA metabolism. These may explain, at least~     in part, sex-related differences in the cardiac DFA uptake, which occurs in pre-diabetes.~     Higher spillover of WAT DFA into circulating Non-Esterified Fatty Acid (NEFA) appears to be~     linked in women to greater cardiac DFA uptake, as opposed to direct cardiac chylomicron~     triglycerides (TG) uptake in men. Here, the investigator will isolate and compare~     organ-specific fatty acid uptake occurring postprandially from chylomicron-TG vs. NEFA pools,~     as well as the oxidative vs. non-oxidative intracellular metabolic pathways associated with~     increased cardiac DFA uptake in pre-diabetic men and women.~   "
57967|NCT02808169|"~     Evaluate the accuracy of Radlink System in determining acetabular cup placement and limb~     length evaluation during Anterior hip replacement as measured intraoperative with C-Arm~     visualization and confirmed with digital x-ray at 4-6 weeks postoperatively.~   "
57968|NCT02808156|"~     This 3-year research project aims to investigate and compare the immediate and long-term~     treatment effectiveness as well as motor improving curve and potential predictors of the~     unimanual intensive training and bimanual intensive training protocols with an equivalent~     intervention period in children with hemiplegic CP and children with CP with apparently one~     side affected. In addition, based on the ICF-CY model, comprehensive outcome measures~     including motor functions as well as psychological functions will be included.~   "
57969|NCT02808143|"~     The purpose of this study is to evaluate the efficacy (the effect of drug on tumor) and the~     tolerability (the effect of drug on the body) of pembrolizumab, when given as a single agent~     in patients with bladder tumors. Another purpose of the study is to see what tumor~     characteristics are associated with increased efficacy of the pembrolizumab. Pembrolizumab~     (MK-3475) is an antibody (a human protein that sticks to a part of the tumor and/or immune~     cells) designed to allow the body's immune system to work against tumor cells. Pembrolizumab~     is Food and drug Administration (FDA) approved for the treatment of advanced melanoma (a type~     of skin cancer) and some types of lung cancer. It is not yet approved by the United States~     Food and Drug Administration (USFDA) for bladder cancer, hence it is considered an~     investigational agent for this disease.~   "
57970|NCT02808130|"~     The investigators hypothesized that hyperlipidemia as an unfavourable levels of lipoprotein~     subfractions have deleterious impact on the development of periodontal infection by altering~     oxidative stres status of periodontal tissues. The aim of this study was therefore to~     investigate i) effect of hyperlipidemia on oxidative change in GCF content, ie. MDA, PC and~     TAOC levels in patients with different periodontal status,~   "
57971|NCT02808117|"~     This study will analyze data from a program run by an microfinance institution (MFI) in Haiti~     from 2011-2012 where the MFI delivered health goods to some of the villages where it~     operates. By comparing health indicators among children who were in villages targeted by the~     program initially to children who were in villages that were not targeted by the program~     until later, the investigators hope to understand if the MFI successfully delivered the~     intervention and offer a practical platform for delivery of basic health goods.~   "
57972|NCT02808104|"~     The purpose of this study is to determine whether a controlled release formulation of~     mazindol is more effective than a placebo in the treatment of Attention Hyperactivity~     Disorder (ADHD) in adults.~   "
57973|NCT02808091|"~     -  Assess responses, progression free survival (PFS) and overall survival (OS) of the~          combination of GIFOX-B chemotherapy with intensity-modulated radiation therapy (IMRT) in~          Stage IB or bulky disease - II and without IMRT in Stage III - IV.~        -  Assess the toxicity and maximum tolerated dose of bortezomib administered in combination~          with GIFOX chemotherapy.~   "
57974|NCT02808078|"~     The GASPAR trial is a pragmatic, parallel-arms, single-center, non-blinded, superiority~     randomized control trial in neurorehabilitation. The main objective is to test whether a 4~     weeks gait rehabilitation program that uses augmented reality is superior to a conventional~     treadmill training program of equivalent intensity. Baseline assessments precede allocation,~     which consists in blocking randomization (2:1 ratio) with stratification according to the~     disease etiology. Post-intervention assessments serve to compare the short-term efficacy of~     the intervention between the two groups. Three months after discharge, follow-up assessments~     take place to detect potential long-term effects.~   "
57975|NCT02808065|"~     Pharmacokinetic model to predict interaction between tacrolimus and mycophenolate was~     developed through clinical trial with healthy volunteer. The purpose of this study is to~     confirm predictability of developed pharmacokinetic model in kidney transplant recipients.~   "
57976|NCT02808052|"~     This is a Phase 1, open-label, single-dose study of the safety, tolerability, and~     pharmacokinetics of Minocin® (minocycline) for injection in subjects with renal~     insufficiency.~   "
57977|NCT02808039|"~     to assess whether cessation of 12 months DAPT regimen containing Ticagrelor results in a~     hyperreactive phase of platelet function~   "
57978|NCT02808026|"~     To examine antihypertensive effect and safety of administration of CS-3150 in patients with~     severe hypertension (Grade III).~   "
57979|NCT02808013|"~     Prospective, Randomized, Double-Blind, Placebo Controlled clinical trial to study the~     efficacy and the safety of NDS-446 (500 mg/cap) in Men 45 years of age or older with moderate~     to severe lower urinary tract symptoms (LUTS)~   "
58015|NCT02807545|"~     This study will be a multi-center, dual-arm randomized control study evaluating skeletally~     immature patients with mild AIS curves. At six institutions, patients will be randomized into~     either the scoliosis-specific exercise (SSE) treatment arm or a control group. The SSE group~     will receive training in SSE, posture, and activities of daily living by physical therapists~     certified in Schroth-based exercise methods. The control group will not receive SSE~     instruction and will only be observed by their treating orthopaedic surgeon (which is~     considered the standard-of-care treatment method). Results will be compared after one year of~     treatment.~   "
57980|NCT02808000|"~     This is a prospective, cross-over, randomized, controlled, partly blinded study evaluating~     safety and performance of noble metal alloy urinary Catheters (BIP Foley, Bactiguard AB) of~     both latex and silicone. The included patients are permanently catheterized spinal cord~     injured patients at the Spinalis clinic at Rehab station in Stockholm, Sweden.~      Primary Outcome Measures:~      • The primary objective is to evaluate the efficacy of long term suprapubic use of BIP Foley~     catheters, compared to the use of standard catheters for the same time period, on re-current~     symptomatic catheter associated urinary tract infection (CAUTIs).~      Secondary Outcome Measures:~      • to evaluate safety/performance of the catheter, i.e. antibiotic use, bacteriuria,~     bacteremia, urosepsis and ICU stay.~      Exploratory Outcome Measures:~      • assessment of levels of immunological markers in urine, urinary bacterial type and~     resistance pattern, catheter comfort, stability of the coating, and bacterial biofilm on the~     catheter surface after use.~   "
57981|NCT02807987|"~     To examine antihypertensive effect and safety of administration of CS-3150 in combination~     with ARB or ACE inhibitor in hypertensive patients with moderate renal impairment.~   "
57982|NCT02807974|"~     To examine antihypertensive effect and safety of administration of CS-3150 in combination~     with ARB or ACE inhibitor in hypertensive patients with type 2 diabetes and albuminuria.~   "
57983|NCT02807961|"~     This is the first study in humans of ELX-02, an advanced synthetic aminoglycoside optimized~     as a translational read-through drug (TRID) for the treatment of genetic conditions caused by~     nonsense. mutations. This is a classical Phase 1a study designed as a randomized,~     double-blinded, placebo-controlled, single dose escalation to evaluate the safety,~     tolerability and pharmacokinetics of ELX-02 in healthy adult volunteers.~   "
57984|NCT02807948|"~     This study is a prospective, non-randomized, multi-center study of subjects implanted with an~     SJM pacemakers, implantable cardioverter defibrillator (ICD), and cardiac resynchronization~     therapy (CRT) devices who are clinically indicated for a non-thoracic MRI scan.~   "
57985|NCT02807935|"~     The purpose of our current series of studies is to evaluate different glaucoma treatments in~     vivo effect on the conventional outflow pathway, and specifically on the Schlemm's canal (SC)~     anatomy using Enhanced Depth Imaging (EDI)-optical coherence tomography (OCT) . The images~     will be taken as part of the patients routine medical follow up (before starting the~     treatment, and 1,4 and 12 weeks afterwards) diameter, cross-sectional area and volume will be~     measured using commercially available 3-dimensional reconstruction.~      The series of studies will be divided into 3 branches, each branch contains different~     treatments.For each treatment different patients will be recruited.~      The branches are as following-~        1. The surgical branch-~             1. Before and after trabeculotomy~             2. Before and after cataract surgery~             3. Before and after vitrectomy surgery~             4. Before and after XEN™ Gel Stent implant~        2. The pharmacological branch-~             1. Before and during the treatment with prostaglandins analogs~             2. Before and during the treatment with alpha blockers~             3. Before and during the treatment with beta blockers~             4. Before and during the treatment with carbonic anhydrase inhibitor~        3. The laser branch-~             1. Before and after trabeculoplasty~             2. Before and after laser iridotomy~             3. Before and after yag capsulotomy laser~   "
57986|NCT02807922|"~     Sleep disturbance is frequent in patients with advanced cancer and decreases the tolerability~     of other symptoms and impairs quality of life. A detailed description of sleep disturbance~     and its association with other symptoms, and intervention studies on sleep medications are~     scarce in patients with advanced cancer. A well-designed randomized controlled trial is~     needed to determine the short time effectiveness of zopiclone on sleep quality, one of the~     currently available therapies of insomnia, and further to contribute to the clinical~     management of insomnia in patients with advanced cancer.~   "
57987|NCT02807909|"~     The study is being conducted to assess the effects of co-administration of itraconazole or~     diltiazem, respectively, on the pharmacokinetic (PK) parameters Cmax, AUC(INF), and AUC(0-T)~     of BMS-986177~   "
57988|NCT02807896|"~     Multiple biomarker development through validation of useful markers generated by next~     generation bio-data based genome research and cohort study~   "
57989|NCT02807883|"~     You are being asked to take part in this study because you either had Ph positive B-lineage~     acute lymphoblastic leukemia (ALL) or still have a small amount of the disease and recently~     received an allogeneic stem cell transplant (cells from someone else).~      The goal of this clinical research study is to learn if blinatumomab in patients who have had~     an allogeneic stem cell transplant can help to control ALL or prevent ALL from coming back in~     patients who either have a small amount of ALL or have had ALL in the past. The safety of~     this drug will also be studied.~   "
57990|NCT02807870|"~     Introduction: Attention deficit/hyperactivity disorder (ADHD) is one of the most prevalent~     mental disorders in children and is associated with important negative functional outcomes~     throughout development. The first signs and symptoms become apparent in preschool age.~     Therefore, early interventions in this population have the potential of limiting the~     disorder's negative impact and preventing future impairments in affected individuals. The~     first-choice medication for treating ADHD is methylphenidate, which has evidence of efficacy~     and safety in preschool children. However, non-evidence based worries and pressure from the~     media placed parent training as the first-line treatment for ADHD in clinical guidelines.~     Parent training is a behavioral intervention implemented with the parents, with weekly~     sessions for 8 weeks, adequate for treating ADHD dysfunctional symptoms and behaviors.~     However, the level of evidence for this intervention is reduced. Furthermore, the need of~     trained therapists in the public health system, added to the difficulties on adherence and~     comprehension from parents, limit its generalization and raise questions regarding its~     indications. Until now, no study has compared pharmacological treatment with methylphenidate~     to parent training in preschool children with ADHD regarding their clinical efficacy and~     cost-effectiveness. Moreover, no study has evaluated the impact of pharmacological~     intervention and psychotherapy on neurobiological mechanisms of ADHD, which is crucial for~     determining their impact on neurodevelopment.~      Objectives: This is a double-blind randomized clinical trial that aims to evaluate the~     efficacy, tolerability and acceptability of treatment with methylphenidate compared to~     parental training and placebo in preschool children with ADHD. Furthermore, the investigators~     propose the use of advanced neuroimaging techniques for the assessment of changes in brain~     connectivity from the institution of treatment.~      Methods: This study will be a randomized, double-blind, parallel-group, evaluating two active~     interventions and placebo control group. One hundred and fifty children aged 3 years and 11~     months and 5 years and 11 months, diagnosed with ADHD, will be randomized to receive~     treatment with methylphenidate and information (50 children), parental training and treatment~     with placebo medication (50 children) or belong to active control group with educational~     information for parents and placebo treatment with no treatment (active control, 50~     children). The treatment will last eight weeks, the neurobiological outcomes will be assessed~     before and after treatment and clinical outcomes will be assessed at weeks 0, 5 and 9 will~     also be evaluated 50 children with typical development in relation to neurobiological~     measures.~      Implications: This study proposes an innovative and relevant analysis, which will enable the~     field to advance the knowledge of biological mechanisms related to ADHD and to treatment~     response. Also, the study will expand the evidence to guide early prevention strategies and~     early intervention.~   "
58421|NCT02802215|"~     Randomized, placebo controlled clinical trial that evaluate the role of taking metformin~     therapy during pregnancy in women with polycystic ovarian syndrome(PCOS) in reducing the~     development of gestational diabetes(GDM) and improving pregnancy outcomes.~   "
57993|NCT02807831|"~     Background: environmental influences in the first years of life have a great impact on~     adulthood. Adequate environmental stimulation in the first years of life positively influence~     cognitive, emotional and neurological development. Studies show that high quality education~     for 3 to 6 years old children are cost-effective for diverse outcomes, such as socioemotional~     and cognitive development, as well as school performance. However, it is not clear why~     specific types of interventions are most effective on school readiness, an important~     precursor of literacy status and later life outcomes. Objectives: adapt to the Brazilian~     context two well-known intervention programs: (1) executive functions training developed by~     Diamond, and (2) oral language skills based on the Nuffield Programme developed by Snowling~     and colleagues. Methods: a randomized controlled trial involving 720 children (4 to 5 years~     old) allocated to three groups: (1) adapted school curriculum focusing on executive functions~     training, (2) adapted school curriculum focusing on oral language skills training, and (3)~     regular school curriculum.~   "
57994|NCT02807818|"~     Home visiting programs for pregnant women aiming to improve mother-infant relationship has~     received worldwide attention in the past 30 years. These programs are considered an important~     strategy to improve women's health during pregnancy, aside from improving child's birthing~     conditions and allowing parents access to tools which will nurture and properly stimulate~     their baby, thus promoting emotional and cognitive development. Objectives: The Nurse home~     visitation program for pregnant youth aims to promote infant´s healthy development, from~     pregnancy to the first months of life, in a high-risk population. Methods: Eighty young~     pregnant women aged between 14 and 20 years were randomly allocated to the intervention or to~     usual prenatal care program. The Nurse home visitation program for pregnant youth was~     developed based on Albert Bandura's theory of self-efficacy, on Urie Bronfenbrenner´s~     bioecological model, which recognizes the importance of individual and family inclusion in~     various contexts of social life, on John Bowlby and Mary Ainsworth evolutionary theories of~     attachment, which involves the care practitioner addressing issues such as environmental~     health, life course and parenting, bond between mother and infant, and infant´s social and~     cognitive development. Neuropsychomotor development will be assessed at 3, 6 and 12 months~     using the Bayley Scale of Infant Development. Brain development will be assessed via~     electroencephalography at 6 and 12 months.~   "
57995|NCT02807805|"~     This phase II trial studies the side effects and how well abiraterone acetate, niclosamide,~     and prednisone work in treating patients with hormone-resistant prostate cancer. Androgens~     can cause the growth of prostate cells. Hormone therapy using abiraterone acetate may fight~     prostate cancer by lowering the amount of androgen the body makes. Niclosamide is a drug that~     may block another signal that can cause prostate cancer cell growth. Prednisone is a drug~     that can help lessen inflammation. Giving abiraterone acetate, niclosamide, and prednisone~     may be a better treatment for patients with hormone-resistant prostate cancer.~   "
57996|NCT02807792|"~     This protocol will test a new prototype of a peri-anal access device, with increased flexible~     length and a captured operative field, for feasibility in patients immediately prior to their~     scheduled peri-anal procedure.~   "
57997|NCT02807779|"~     This is a prospective, multicenter, randomized trial to determine the mechanisms of vascular~     healing. The study will evaluate subjects with peripheral artery disease (PAD) who require an~     endovascular intervention of the femoro-popliteal (SFA) artery to restore blood flow to the~     leg.~   "
57998|NCT02807766|"~     Autism is a well-recognized neurodevelopmental disorder severely affecting the health of~     children. While the unclear neurobiological basis of autism and the lack of effective~     medication, the most commonly used approach for treatment is behavioral intervention.~     However, the pathophysiological mechanisms underlying the intervention therapy remains~     incompletely understood. The current project aims to explore the impacts of different early~     behavioral intervention methods on brain plasticity of autism using multimodal MRI technique~     and provide guidelines for the intervention and treatment of autism by evaluating the~     efficiency of these methods.~   "
57999|NCT02807753|"~     To evaluate the prevalence of subclinical arthropathy in children with severe hemophilia~     undergoing a prophylaxis regimen and without evidence of target joints, using a validated~     ultrasound scoring method.~   "
58000|NCT02807740|"~     Patients affected by Parkinson disease (PD) can benefit from rehabilitation although the~     evidences are scattered. In the last years there are increased evidences that virtual reality~     can improve functional outcome in Parkinson's disease. No evidences are known concerning the~     cardiological safety and effect on balance of Virtual Reality. The aim of this study is to~     compare a virtual reality rehabilitation program versus a conventional one in a sample of~     patients affected by mild to moderate Parkinson and to collect data on cardiological effects.~   "
58001|NCT02807727|"~     This study will evaluate the benefit of Intralipid® or placebo administered prior to~     reperfusion to limit ischemia reperfusion injury as measured by the geometric mean difference~     of the release of troponin I over 72 hours after coronary artery bypass.~   "
58002|NCT02807714|"~     The purpose of this study is to find an association between a protein named Podocan and WNT~     pathway regulatory molecules in patients with different forms of Coronary Artery Disease~     (Acute Coronary syndrome, Stable Angina and Coronary Artery Restenosis). It has been found in~     experimental studies that this protein is regulating smooth muscle cell function and hence~     may be influencing the progression of Coronary Artery Disease (CAD). We are testing to see if~     the same regulatory function exists in human subjects. Studying patient's blood will possibly~     enable to identify an association between Podocan and CAD. This may help to better prevent~     and treat CAD with improved understanding of the mechanism of the disease. No drugs or other~     therapeutic interventions will be used for the purpose of the research study. Only blood~     samples will be collected in the cardiac catheterization lab. As a part of this study~     participants will be followed for repeat events or repeat cardiac catheterization over a~     period of 24 months.~   "
58016|NCT02807532|"~     To investigate whether apelin can be used as an indicator to predict postoperative atrial~     fibrillation in patients with coronary atherosclerotic heart disease, and to provide an~     objective basis for the clinical selection of a preventive intervention program for atrial~     fibrillation.~   "
58436|NCT02802020|"~     To prospectively document the performance of a FCSEMS for treatment of pancreatic duct~     strictures in patients with painful chronic pancreatitis.~   "
58003|NCT02807701|"~     Open pancreaticoduodenectomy (PD) is the standard treatment for a wide array of periampullary~     and pancreatic diseases including malignant and benign conditions. The outcome of PD has~     improved over the last two decades due to advances in surgical techniques, anesthesia and~     perioperative care. Although studies from high volume centers demonstrate reduce in the~     operative mortality to less than 3%, the postoperative morbidity rate is still ranging from~     30% to 60%. Laparoscopic surgery is being used increasingly as a less invasive alternative to~     traditional interventions for pancreatic resection. Laparoscopic pancreaticoduodenectomy~     (LPD) is a difficult procedure that has become increasingly popular. Nevertheless,~     comparative data on outcomes remain limited. In this prospective randomized study,~     investigators evaluate the safety and feasibility of surgical and oncological outcomes of~     minimally invasive PD compared to conventional open PD.~   "
58004|NCT02807688|"~     The study evaluates the efficacy of health promotion strategies on diet and physical activity~     in patients with psychosis. Half of the participants will receive an intervention protocol~     based on education and behavioural change, while half will not receive it.~   "
58005|NCT02807675|"~     This study is a double-blind, randomized, placebo-controlled, 2-way crossover study to~     evaluate the safety of CVT-301 levodopa (l-dopa) when co- administered with the first daily~     dose of oral levodopa/carbidopa for early morning OFF symptoms in patients with Parkinson's~     disease (PD).~   "
58006|NCT02807662|"~     The objectives of this research study are to screen 750 pregnant women at risk of~     trauma-related stress symptoms, and adapt and test an evidence-based intervention for~     pregnant women with PTSD and sub-threshold PTSD symptoms served by two public payer community~     health centers.~   "
58007|NCT02807649|"~     To evaluate the efficacy of Nutrilite® ginkgo biloba cistanche tablets in relieving the~     symptoms of chronic fatigue syndrome(CFS), the investigators randomly recruit189 subjects~     with CFS, aged 35-60 yrs. The relief of fatigue and improvement of sexual function are~     evaluated by World Health Organization Quality Of Life Brief (WHOQoL-Bref), Sexual Life~     Quality Questionnaire (SLQQ), chronic fatigue syndrome, symptoms of self-assessment at the~     baseline and the end of intervention. Subjects also underwent a blood test measuring the~     concentration of biochemical indicators. Cistanche is mainly used to strengthen the renal~     function, nourish essence and blood in the treatment of lumbar debility, impotence,~     infertility and muscles weakness, constipation. etc. The study is to test the hypothesis that~     consecutive 60-day intake of the study tablets can relieve the symptoms of CFS; according to~     the change of blood biology indicators, the investigators will also evaluate the association~     between the change of plasma outcome measures and chronic fatigue syndrome.~   "
58008|NCT02807636|"~     A Phase III, randomised study of atezolizumab alone and in combination with chemotherapy~     versus chemotherapy alone in participants with untreated advanced urothelial cancer.~   "
58009|NCT02807623|"~     The purpose of this clinical investigation is to evaluate the efficacy and immunologic~     effects of a non-pharmacological exercise intervention (pushups) compared to an oral NSAID~     (ibuprofen) and an oral placebo to decrease local injection site inflammation symptoms of~     delayed pain, erythema, and edema and any impact on serologic antibody immune response after~     influenza vaccine receipt.~   "
58010|NCT02807610|"~     The ideal induction agent for day care surgery should have properties of rapid, smooth~     induction, better haemodynamic profile, faster recovery and devoid of side effects in the~     form of pain on injection, involuntary movements, respiratory depression and post-operative~     nausea/vomiting. Propofol is the drug being used for day care surgeries because of its rapid,~     smooth induction and faster recovery. But its use is associated with pain on injection (even~     with added lidocaine), hypotension and respiratory depression. So the need for an agent with~     better hemodynamic control and lesser side effects was felt. The introduction of etomidate~     lipuro revolutionised the anaesthesia practice. It possesses many of the properties of an~     ideal induction agent. This newer formulation of etomidate in lipid emulsion i.e. etomidate~     lipuro is known to have rapid, smooth induction, haemodynamic stability and lesser side~     effects than older etomidate with propylene glycol (hypnomidate).~      Hence, investigators devised a prospective randomized controlled open trial and compared this~     newer lipid formulation of etomidate with propofol in terms of - induction time, haemodynamic~     parameters and side effect profile.~   "
58011|NCT02807597|"~     The investigators' preclinical data have demonstrated the feasibility of fluorescence-guided~     tumor resection by Cancer Vision Goggles (CVG) with LS301 in animal models. In this study,~     the investigators will conduct intraoperative imaging procedures that have minimal~     interference with ongoing surgery. The underlying hypothesis is that the accurate detection~     of all cancer cells highlighted by LS301 during surgery will reduce the number of breast~     cancer patients with margin positivity to less than 5%, compared to the current surgical~     paradigm of greater than 20%. The pilot study will obtain critical data required to address~     the larger question of surgical margin assessment in a full Phase I clinical trial.~   "
58012|NCT02807584|"~     This study will look at whether ELECT, a new adhesive foam dressing, can offer an alternative~     to traditional wound care methods.~      Patients will be treated with ELECT for 14 days. Data relating to wound healing, the~     performance of the dressing and the opinion of the doctor will be collected.~      The hypothesis of this study is that the ELECT foam adhesive dressing is 'fit for purpose'~     and will be effective at treating a variety of wounds.~   "
58013|NCT02807571|"~     This study is aimed at determining if office based surgery is an effective way of cutting~     health care cost while maintaining patient safety and satisfaction.~   "
58014|NCT02807558|"~     The purpose of this study is to determine the activity of SY-1425 in relapsed/refractory~     acute myeloid leukemia (AML) patients, relapsed/refractory higher-risk myelodysplastic~     syndrome (MDS) patients (SY-1425 administered as a monotherapy or in combination with~     daratumumab), newly diagnosed treatment naïve AML patients who are unlikely to tolerate~     standard intensive chemotherapy (SY-1425 administered as a monotherapy or in combination with~     azacitidine), or lower-risk myelodysplastic syndrome (MDS) patients (SY-1425 administered as~     a monotherapy) who are positive for a RARA biomarker.~   "
58043|NCT02807181|"~     The study will evaluate the benefit of applying Selective Internal Radiation Therapy (SIRT)~     using SIR-Spheres Y-90 resin microspheres prior to receiving systemic chemotherapy treatment~     (cisplatin-gemcitabine, or CIS-GEM) in patients with unresectable intrahepatic~     cholangiocarcinoma. Half of the patients will be randomized to CIS-GEM chemotherapy plus~     SIRT, and half of the patients will be randomized to CIS-GEM alone.~   "
58017|NCT02807519|"~     Oral complications during and after cancer treatment are common. A key role in maintaining~     oral health plays saliva. In the last decade numerous studies have investigated immunological~     biomarkers such as cytokines in saliva samples. In children, the few studies have~     investigated salivary cytokines (sCK) suggesting that these are associated with oral health~     (sCK). One study investigating sCK in adult oncology patients showed an association between~     Interleukin-6 (IL-6) and severity of oral chronic graft-versus-host disease (GVHD) in~     survivors of hematopoietic stem cell transplantation. Therefore determination of sCK~     concentrations may also be helpful for assessment of GVHD activity and other inflammatory~     processes in cancer patients. In pediatric oncology patients, to the investigators'~     knowledge, no study has so far investigated sCK concentrations as markers for oral or~     systemic health.~   "
58018|NCT02807506|"~     This project develops and tests the use of service robots to track health of the elderly over~     time. The objectives are to develop a low-cost mobile manipulator capable of a limited set of~     elder- relevant manipulation tasks (e.g. picking up dropped items). The investigators will~     visualize and model the use of the service robot during deployments at an elder care~     facility. Feedback from focus groups with elders and clinicians will inform the necessary~     engineering innovation.~   "
58019|NCT02807493|"~     The primary objectives of this study are to determine if the use of an Occlusal Support~     Device (OSD)(Mouthguard) can reduce the duration and intensity of the second stage of labor,~     reduce the incidence of labor complications including Caesarian Sections and improve Apgar~     scores in newborns~   "
58020|NCT02807480|"~     This project aims to identify brain and behavioral characteristics of individuals~     experiencing symptoms of generalized anxiety disorder that will predict the effectiveness of~     Exposure-based therapy versus Behavioral Activation Therapy. Brain imaging aspects of the~     study will use functional magnetic resonance imaging (fMRI) and electroencephalography (EEG).~     Behavioral assessments will include self-report questionnaires, computer-based and~     observational tasks, and interviews. Assessments will focus on how individuals process~     positive information (such as reward) and negative information (such as distressing images),~     as well as how people make decisions. These assessments will be conducted across 2-3~     in-person sessions prior to beginning the treatment, and will be repeated across 2-3~     in-person sessions after completing treatment. A blood draw will also be conducted pre- and~     post- treatment. Both the Exposure-based and Behavior Activation therapy will consist of 10,~     90-minute weekly therapy sessions conducted in small groups.~   "
58021|NCT02807467|"~     In this randomized study, the investigators aim to test the hypothesis that the reinstitution~     of a normal circadian rhythm by continuous infusions of dexmedetomidine compared to propofol~     between 8pm and 6am after diagnosis of hyperactive or mixed delirium, decreases the duration~     of delirium. The infusions might have to be repeated several times to achieve resolution of~     delirium.~   "
58022|NCT02807454|"~     This is an open-label, multicenter study to confirm the safety and efficacy of durvalumab +~     daratumumab (D2) in subjects with relapsed and refractory multiple myeloma. This study will~     also explore the safety and efficacy of the addition of pomalidomide + dexamethasone to~     durvalumab + daratumumab (PD3).~      On 05 Sep 2017, a Partial Clinical Hold was placed on this study by the United States (US)~     Food and Drug Administration (FDA). The decision by the FDA was based on data related to~     risks of anti-programmed cell death-1 (PD-1) antibody, pembrolizumab, in combination with~     IMiDs® immunomodulatory drugs in patients with multiple myeloma. As a result, enrollment into~     this study has been discontinued. Subjects who are receiving clinical benefit, based on the~     discretion of the investigator, may remain on study treatment after being reconsented.~   "
58023|NCT02807441|"~     The investigators would like to further the current understanding of aspirin and its effects~     on perioperative bleeding by conducting a randomized controlled trial of spinal surgery~     patients receiving varying doses of aspirin or no aspirin perioperatively. The investigators~     hypothesize that there will be no significant difference in perioperative blood loss between~     the different groups.~   "
58024|NCT02807428|"~     The objectives of this study are to evaluate the safety and analgesic efficacy of a single~     preoperative intrathecal administration of AYX1 Injection in patients undergoing unilateral~     total knee arthroplasty.~   "
58025|NCT02807415|"~     The academic investigator - initiated trial will evaluate in a postapproval setting whether,~     and if yes, to what extent and variability, the treatment with lumacaftor in combination with~     ivacaftor reverses the p.Phe508del CFTR - mediated basic defect in p.Phe508del homozygous~     subjects with cystic fibrosis under real life conditions.~   "
58026|NCT02807402|"~     This study seeks to provide evidence of the effectiveness and obtain patient reported outcome~     (PRO) data for the interferon-free ABBVIE REGIMEN ± RBV in participants with chronic~     hepatitis C (CHC) in a real life setting across clinical practice patient populations in~     Romania~   "
58027|NCT02807389|"~     The investigators propose to study the safety of autologous mesenchymal stromal cell transfer~     using a biomatrix (The Gore Fistula Plug) in a Phase I study using a single dose of 20~     million cells. 15 adult patients (age 18 and greater) with persistent symptomatic~     post-surgical gastrointestinal leaks despite current standard radiologic and endoscopic~     therapies will be enrolled. The subjects will be subsequently followed for fistula response~     and closure for 18 months. This is an autologous product derived from the patient and used~     only for the same patient.~   "
58028|NCT02807376|"~     This prospective, randomized, controlled, multi-center study will collect and compare data~     from the surgeon's current standard of care stapler (for renal artery and renal vein~     transection) and powered vascular stapler~   "
58029|NCT02807363|"~     This Phase 2a, pharmacokinetic/pharmacodynamic study will determine the safety and provide~     evaluation of the PK/PD metrics of three different oral doses selected upon the results of~     the study LOPDT-PH1-01 - 4 mg oral tablets administered over 28 days as QD and BID regimens~     and 10 mg oral tablets administered over 28 days as a BID regimen. The PK/PD profiles of the~     study drug will be compared to the leuprolide formulation approved for the treatment of~     endometriosis (a monthly intramuscular injection, Lupron Depot 3.75 mg). Major PK (e.g., a~     total exposure to leuprolide) and PD parameters (e.g., rates of the estradiol suppression and~     cessation of the menstrual period) will also be evaluated against the Lupron Depot historical~     data.~   "
66422|NCT02697552|"~     Phase 1, open-label, non-randomized, dose-escalation study to evaluate the safety,~     tolerability, pharmacokinetics (PK), and preliminary efficacy of HBI-8000 administered~     orally.~   "
58031|NCT02807337|"~     Prospective double-blinded randomized clinical study. Aim of the study is to compare the~     effectiveness of Caphosol mouth rinses in prevention of oral mucositis as compared to 0.9%~     NaCl rinses. Patients will be randomized to receive either Caphosol or 0.9% NaCl rinses four~     times a day for seven days from the beginning of chemotherapeutic regimen. The same patient~     will be given the opposite rinse during the next chemotherapeutic regimen, so everyone will~     get both mouth rinses once during the trial.~   "
58032|NCT02807324|"~     Pregnancy is considered a cardiovascular (CV) stress test, and complicated pregnancies are~     associated with an increased risk for cardiovascular disease (CVD) later in life. Moreover,~     it is known that often the pregnancy induced CV adaptation does not resolve completely after~     a short postpartum (PP) period and it is not clear whether these induced changes will resolve~     over a longer period of time (i.e. in the upcoming months/years after delivery).~     Understanding the cardiac adaptation during pregnancy and the reversal process in the~     postpartum period, as well as the factors that influence this these processes, may provide us~     not only insight in this mechanism, but may help us in identifying factors that may be target~     points for modification.~   "
58033|NCT02807311|"~     Undernutrition is the result of energy and protein deficiency and / or catabolic. These~     phenomena are observed daily in patients awaiting lung transplantation.~      After lung transplantation that undernutrition is growing (on average 11% weight loss after~     the first observations in the continuing care of the University Hospital of Strasbourg). In~     other words the non-malnourished patients become. Hence the importance to reach every patient~     awaiting transplant, mainly to patients already malnourished before surgery.~      Several studies have shown that early nutritional support has a direct effect on reducing~     comorbidities and the average length of stay. In the course of care of these patients it is~     necessary to intensify the dietary management to give them the best chance for early~     rehabilitation.~      The main objective of the study is to evaluate the impact of the use of the SFNEP's~     nutritional care decision-making tree (Société Francophone Nutrition Clinique et Métabolisme)~     on the implementation of enteral nutrition by gastrostomy tube in patients awaiting for lung~     transplantation.~   "
58034|NCT02807298|"~     This study compared the anesthetic efficacy between Lignocaine and articaine administering it~     intraligamentarly using ligajet in twenty five female patients having irreversible pulpitis~     on bilateral mandibular molars. At 5minutes of post injection, the teeth were isolated with~     rubber dam and access performed. Patients were instructed to definitively rate any pain felt~     during endodontic procedure. If patient felt pain, the treatment was immediately stopped and~     the patient rated their discomfort using Heft Parker VAS. The extent of access achieved when~     the patient felt pain was recorded as within dentin, entering the pulp chamber or initial~     file placement. The success was defined as the ability to access and instrument the tooth~     without pain (VAS score of zero) or mild pain (VAS rating<54mm).~   "
58035|NCT02807285|"~     The primary objective of this expanded access program is to provide ocrelizumab as treatment~     for eligible participants with primary progressive multiple sclerosis (PPMS) before it is~     commercially available in the United States (U.S.) for the indication of PPMS.~   "
58036|NCT02807272|"~     A Phase 2 study to investigate the antitumor activity in terms of overall response rate (ORR)~     of tipifarnib in approximately 20 eligible subjects with CMML. Subjects will receive~     tipifarnib administered orally, twice a day (bid) for 7 days in alternating weeks (Days 1-7~     and 15-21) in 28 day cycles. In the absence of unmanageable toxicities, subjects may continue~     to receive tipifarnib treatment until disease progression. If a complete response is~     observed, therapy with tipifarnib will be maintained for at least 6 months beyond the start~     of response.~   "
58037|NCT02807259|"~     Female sex workers (FSWs) frequently experience violence from their intimate partners~     (non-paying lovers), which compromises their health and increases their the risk of infection~     with HIV or other sexually transmitted infections. Samdevena Plus is a complex multi-level~     intervention that works with FSWs, their intimate partners, the sex worker community and the~     general population. The intervention aims to reduce partner violence and increase consistent~     condom use within these relationships.~      The intervention consists of: (i) couples counselling sessions between FSWs and their~     intimate partners; (ii) separate group work among FSWs and intimate partners to increase~     self-esteem and encourage reflection about violence; (iii) strengthening supportive crisis~     management systems that address domestic and sex worker violence; (iv) training male~     'champions' to encourage action against violence; and (v) training media to promote informed~     discussions about violence and HIV risk.The program involves changing perceptions on~     acceptability of physical violence as a form of discipline, challenging assumptions that give~     men authority over women, and working with men and women to encourage new relationship models~     based on equality and respect. The intervention will reach 800 FSWs and their intimate~     partners living in 47 villages in north Karnataka, India. The evaluation uses a~     cluster-randomized control trial design that introduces the intervention into half of~     villages for the first 24 months and the remaining half receive the intervention thereafter.~     The primary outcomes of the trial are: the proportion of FSWs who report: i) consistent~     condom use in their intimate relationship; and ii) experiencing partner violence within the~     past 6 months.~   "
58038|NCT02807246|"~     This study was designed as a prospective controlled study to investigate the effects of~     probiotic support started immediately after birth on newborn jaundice in breastfed babies~     born by normal spontaneous vaginal delivery.~   "
58039|NCT02807233|"~     The purpose of this study is to evaluate the effectiveness in IGF-1 control of lanreotide~     Autogel (ATG) 120 mg at extended dosing intervals (EDIs) (>4 weeks) in subjects with~     acromegaly in daily clinical practice.~   "
58040|NCT02807220|"~     The objective of this study is to evaluate the efficacy and safety of Imuneks 10 mg Capsules~     in the prophylaxis of cold and the maintenance of the good health state in 70 healthy~     subjects.~   "
58041|NCT02807207|"~     The primary objective is to evaluate the cardiac safety of a single oral dose (400 mg) of~     pacritinib compared to placebo on the QT calculated using the Fridericia correction (QTcF)~     interval in healthy subjects.~   "
58042|NCT02807194|"~     Primary Goal: To compare the clinical outcomes of spinal anesthesia and general anesthesia in~     surgery for lumbar disc herniation.~   "
67146|NCT02688049|"~     The purpose of this study is to assess the efficacy and safety of mesenchymal stem cells or~     neural stem cells combined with NeuroRegen scaffold transplantation in patients with spinal~     cord injury.~   "
58044|NCT02807168|"~     Acute decompensated heart failure (ADHF) is a health problem of great magnitude, because it~     is the most frequent cause of hospitalization of patients over 65 years old. Of these~     patients, more than 50% will be readmitted within the next six months with the consequent~     worsening prognosis, increased mortality and high costs associated. In fact, two-third parts~     of the costs of this condition are due to hospitalizations. Hence the increased importance of~     ADHF and its associated hospitalizations as an essential event in the natural history of the~     disease on to address therapeutic efforts.~      However, at the present time there is a change of scenario that makes that more than half of~     these patients show HF with preserved ejection fraction (PEF), so that acute heart failure~     with preserved ejection fraction (AHF-PEF) is a fact with high prevalence and epidemiological~     relevance. To this the investigators must add that, unlike patients with depressed EF, HF-PEF~     has no therapeutic strategies that may have proven a recovery of the affected patients. All~     this makes that overall heart failure with PEF and AHF-PEF represent a major health problem.~      However, despite of the lack of effective treatments, there are also opportunities for~     improvement both in terms of morbidity and mortality that should be evaluated. Rather than~     looking for therapies or new specific drugs, these opportunities may be in the use of~     management strategies among which the use of biomarkers and their monitoring could be key. In~     this regard, NT-proBNP has been shown to correlate with severity and prognosis, including the~     risk of decompensation. Nevertheless, whilst the latest guidelines for heart failure~     management recommend its use in the diagnosis of HF, the use of biomarkers to monitor and~     guide treatment has not been included yet.~      The assumption of this study is that the use of NT-proBNP may serve as a therapeutic and~     management guideline for the in-patient with HF-PEF who is to be discharged, allowing a~     reduction of decompensations and hospitalizations as well as a better functional situation at~     6 months.~      Several criteria have been proposed to define the syndrome of HFpEF according to the 2013~     ACCF/AHA Heart Failure Guideline including (a) clinical signs or symptoms of HF; (b) evidence~     of preserved or normal LVEF; and (c) evidence of abnormal LV diastolic dysfunction that can~     be determined by Doppler echocardiography or cardiac catheterization The assay N‑terminal~     proB‑type natriuretic peptid is indicated as an aid in the diagnosis of individuals suspected~     of having congestive heart failure and detection of mild forms of cardiac dysfunction. The~     test also aids in the assessment of heart failure severity in patients diagnosed with~     congestive heart failure. This assay is further indicated for the risk stratification of~     patients with acute coronary syndrome and congestive heart failure, and it can also be used~     for monitoring the treatment in patients with left ventricular dysfunction.~   "
58045|NCT02807155|"~     In Los Angeles County, the most populous county in the United States, there are an estimated~     8,000 children under the age of 21 with type 1 diabetes. Although provisions for pediatric~     care exist, once these children become young adults they age out of their health care~     services. There is no formal transitional care program to help these individuals through this~     process of changing health plans and many end up without adequate care. This project aims to~     develop and implement a transition care program for young adults with type 1 diabetes in~     order to ensure uninterrupted transition from pediatric to adult diabetes health care and~     improve health and psychological outcomes.~   "
58046|NCT02807142|"~     The objective of the study is to determine if the cell therapy NC1 administered in the spinal~     cord is effective for the treatment of a post-traumatic syringomyelia. The post-traumatic~     syringomyelia is the development and progression of cyst filled with cerebrospinal fluid~     (CSF) within the spinal cord. The cell therapy NC1 consist on cells obtained from the bone~     marrow of the patient, that are cultured in vitro and administered in the spinal cord of the~     same patient.~   "
58047|NCT02807129|"~     The aim of the study is to evaluate frailty in patients aged ≥ 65 years with cancer. The~     elderly population is very heterogeneous, it is necessary to evaluate these elderly patients~     before treatment to assess the risk-benefit balance. To date, this assessment relies on~     subjective clinical methods often not optimal, and slow to implement. An innovative method of~     evaluation could be the determination of elastin peptides. Indeed, the rate of these~     peptides, which are linked to serious conditions associated with age, rising inexorably with~     age and dose could help determine more objectively the type of treatment to offer older~     patients.~      Expected results : This study will allow better identification of the group of frail elderly~     through more relevant biological marker that clinical assessment, often subjective and not~     available within a period compatible with the treatment of newly diagnosed cancer. This~     biological assessment will also enable optimal management of elderly patients in particular~     by allowing the geriatrician better efficiency.~   "
58048|NCT02807116|"~     The primary objective is to evaluate the effect of rifampin, a potent cytochrome P450 3A4~     inducer, at steady-state on the systemic exposure of a single dose of pacritinib in healthy~     subjects.~   "
58049|NCT02807103|"~     Phase III, comparative, multicenter, randomized, controlled, double-blind and superiority~     research, comparing rituximab-based regimen with conventional therapeutic strategy for the~     induction of remission in patients with eosinophilic granulomatosis with polyangiitis (EGPA).~      Patients with newly diagnosed or relapsing EGPA will be randomized in a 1:1 ratio to receive:~        -  Experimental therapeutic strategy based on the use of rituximab (experimental group)~        -  Conventional therapeutic strategy based on Five-Factor Score (FFS)-assessed disease~          severity (comparative group)~   "
58050|NCT02807090|"~     Supervised exercises are the first line therapy for patients with chronic low back pain. The~     lumbar segmental stabilization (LSE) is a specific training for the muscles of the lumbar~     spine, which aims to improve neuromuscular control, strength and endurance of the muscles~     that promotes stability to the spine. The circular dance (CD) belongs to the group of~     complementary and integrative practices entered in Public Health Care in Brazil, and has been~     used to improve several aspects related to physical and mental states such as flexibility,~     posture, strength and muscular endurance, awareness or scheme body, pain control and strains.~     There are few studies evaluating the circular dance effect on back pain. The aim of this~     study is to compare the effects of lumbar stabilization exercises and circular dance for~     improvement in non specific low back pain in middle-aged women.~   "
58051|NCT02807077|"~     This is a Phase 1 open label, single dose, 5 parallel-group study in which a single 400 mg~     dose of pacritinib will be administered orally to patients with renal impairment (mild,~     moderate, severe, and patients with ESRD requiring hemodialysis) and sex-, age- and~     weight-matched healthy subjects.Patients with ESRD will receive a single 400 mg dose of~     pacritinib during 2 different treatment periods: Dialysis and Inter-Dialysis. The primary~     objective of the study is to evaluate the pharmacokinetics and safety of pacritinib in renal~     impairment.~   "
58052|NCT02807064|"~     This study is aimed at assessing the efficacy of supplementation with a mixture of three~     bifidobacteria , on the allergic rhinitis..The rhinitis symptoms were assessed by validated~     score ( TSS ) , for children aged between 4 and 17 years with allergic rhinitis parietaria ,~     mild , moderate or severe , than children not supplemented .~      Secondary Objectives~        -  The effectiveness of treatment by VAS :~        -  Evaluation of the rescue medication consumption~        -  Evaluation of quality of life ( using structured questionnaire )~        -  Evaluation of the frequency and school performance ( using structured questionnaire )~        -  Assessment of sleep quality and attention (through structured questionnaire )~        -  Satisfaction rating and satisfaction of parents~        -  Evaluation of asthma exacerbations in children susceptible~   "
58055|NCT02807025|"~     Nasal, tracheal and bronchial sampling of MLF in patients with idiopathic pulmonary~     fibrosis(IPF), sarcoidosis, tuberculosis(TB), asthma and COPD. Similar sampling from healthy~     controls for comparative data.~      Aim: To characterise the molecular basis of the upper and lower airway mucosa inflammatory~     response in different respiratory diseases. To assess molecular biomarkers and signatures to~     see if these can aid diagnosis, stratification of these respiratory diseases. To direct~     personalised medicine and rationalise therapy.~      Outcome measures:Measurement of levels of inflammation, coagulation, complement activation~     and fibrosis in MLF, transcriptomics from nasal curettage and airway brushings and to assess~     the tolerability of absorption procedures in these patients.~   "
58056|NCT02807012|"~     Associated with the worsening of functional capacity of older adult and the lack of guidance~     on how to care of them after stroke, the family caregiver starts to fell burden related to~     the care, and the quality of life was affected by that burden. Besides that, the older adult~     began to use more frequently health services and had more hospitalizations by preventable~     conditionals with adequate care.~      The aim of this study is to evaluate the effectiveness of educational interventions of care~     at home provide by nurses to family caregivers of older adult with stroke after hospital~     discharge, compared with usual care guidelines or no guidance, in one month follow up. The~     family caregivers of older adults post stroke with the first functional sequel from the~     Clinical Hospital of Porto Alegre (HCPA) will participate in the study.~      The intervention will involve the systematic monitoring of nurses through home visits (HVs)~     during one month. Thus, will instrumentalize the family caregiver to care of older adult with~     stoke according the protocol developed in a research group and the needs of care of them. The~     control group won't receive the home visits and could have or not the usual care guidelines~     provide by health services that have access.~   "
58057|NCT02806999|"~     Berberine is a conventional component in Chinese medicine. In recent years, effects of~     Berberine on improvement of glucose metabolism have been explored. The purpose of this study~     is to observe the therapeutic effects of combination of insulin and berberine on stress~     hyperglycemia in patients after cardiac surgery.~   "
58058|NCT02806986|"~     Approximately 60 subjects will be enrolled in order to have approximately 20 adult subjects~     and 20 pediatric subjects treated with subcutaneously administered IGSC 20% who complete the~     entire study. This study will include 3 study stages: Screening/Previous Regimen Phase, IGSC~     20% Treatment Stage 1 (13 IGSC 20% weekly doses), and IGSC 20% Treatment Stage 2 (39 IGSC 20%~     weekly doses). A total of 52 doses of IGSC 20% will be administered with a final follow-up~     visit 1 week after the last dose at Week 53. Subjects/caregivers will be trained on~     self-administration of IGSC 20% by the clinical site personnel.~   "
58059|NCT02806973|"~     This study will investigate how the body processes LY900018 and the effect of LY900018 on the~     body. The study drug will be delivered into the participant's nostril(s) (intranasally) once~     or twice in each of four study periods. The study is expected to last about 50 days for each~     participant. The study is open to adults with type 1 or type 2 diabetes and will last about~     50 days.~   "
58060|NCT02806960|"~     This study will investigate how the body processes LY900018 and the effect of LY900018 on the~     body. The study drug will be delivered into the participant's nostril(s) (intranasally) once~     or twice in each of four study periods. The study is open to adults with type 1 or type 2~     diabetes and is expected to last about 50 days for each participant.~   "
58061|NCT02806947|"~     The study is a Phase II randomized, open label, multicenter trial designed to identify~     whether sirolimus is a potential alternative to prednisone as an up-front treatment for~     patients with standard-risk acute GVHD defined according to clinical and biomarker-based risk~     stratification. This trial incorporates both a novel up front GVHD therapy (sirolimus) as~     well as a novel BMT CTN developed acute GVHD biomarker test.~   "
58062|NCT02806934|"~     Do TNF-308 and -238 polymorphisms impact the embryo implantation rate after in vitro~     fertilization (IVF) in women without female infertility factor ?~   "
58063|NCT02806921|"~     The purpose of this study is to investigate changes in the level of inflammatory mediators in~     the tear film of scleral contact lens wearers in a keratoconic population.~   "
58064|NCT02806908|"~     This trial is a randomized, double-blind, placebo-controlled, crossover study to evaluate the~     effect of JZP-110 on driving performance in subjects with excessive sleepiness due to~     narcolepsy.~   "
58065|NCT02806895|"~     This trial is a randomized, double-blind, placebo-controlled, crossover study to evaluate the~     effect of JZP-110 on driving performance in subjects with excessive sleepiness due to~     obstructive sleep apnea.~   "
58066|NCT02806882|"~     Ceftaroline is a piece of new cephalosporin very active on resistant staphylococci in~     methicillin (SEMR: Staphylococcus Epidermidis Resistant in Methicillin, SMAR: Staphylococcus~     Aureus Resistant in Methicillin)and/or in vancomycin ; Ceftaroline is also very active on~     pneumococci resistant in penicillin and/or 3rd generation of cephalosporins.~      Ceftaroline was approved by the European Medicines Agency for the treatment of complicated~     skin and soft tissue infections and community-acquired pneumonia.~      Scientific literature describes a good efficiency in septicemy and/or SAMR endocarditis.~      Besides, a study on animal shows the efficiency of ceftaroline in meningeal infections with~     gram-negative Bacilli.~      The rationale of this study is based on the antibacterial spectra of ceftaroline that could~     be used for the antibacterial treatment (curative and prophylactic) of CSF shunt associated~     infections.~      To validate this hypothesis, it is necessary to evaluate the concentration of ceftaroline in~     meningeal compartment after treatment.~   "
58067|NCT02806869|"~     In vivo drug dissolution in the gastrointestinal (GI) tract is largely unmeasured. The~     purpose of this clinical study was to evaluate the in vivo drug dissolution and systemic~     absorption of the BCS Class IIa drug ibuprofen under fed and fasted conditions by direct~     sampling of stomach and small intestinal luminal content. Expanding current knowledge of drug~     dissolution in vivo will help to establish physiologically relevant in vitro models~     predictive of drug dissolution.~   "
58247|NCT02804477|"~     This study aims at finding degree of adherence of patients to their chronic pain medication~     prescriptions containing opioid e.g. Morphine, using Morisky Medication Adherence Scale 8,~     self- reported questionnaire. Also relationship of various demographic, disease related and~     opioid related factors to medication adherence.~   "
58068|NCT02806856|"~     Very early after the onset of the focal perfusion deficit, excitotoxic mechanisms can~     lethally damage neurons and glia. Excitotoxicity triggers a number of events that can further~     contribute to tissue death. Such events include peri-infarct depolarizations (PID) and~     cortical spreading depolarization (CSD) within the peri-infarct zone or ischaemic penumbra.~     Noninvasive brain stimulation techniques such as transcranial direct current stimulation~     (tDCS) are emerging as promising tools, owing to their effects on modulating cortical~     activity. Experimental studies have indicated that cathodic polarization of the cortical~     surface blocks initiation of CSD. Moreover, it has been recently demonstrated in murine~     stroke models that cathodal tDCS exerts a measurable neuroprotective effect in the acute~     phase of stroke, decreasing the number of spreading depolarizations and reducing the infarct~     volume by 20 to 30%.~      The investigators propose here a pilot study, in acute middle cerebral artery stroke~     patients, with a double blind randomization: cathodal tDCS versus sham tDCS. The duration of~     this study will be two years. Fifty acute middle cerebral artery stroke patients will be~     included. The tDCS will begin within 4.5 hours of symptom onset. The main criteria of~     evaluation will be the extent of diffusion-weighted imaging (DWI) infarct volume between~     imaging on admission and 24 hours later. The investigators propose the hypothesis that in~     acute stroke patients, cathodal tDCS could be an adjuvant approach to recanalizing therapies.~   "
58069|NCT02806843|"~     Our study goal is to assess natural patient-therapist interactions in order to map such~     human-human activities to robot-human interactions. Critical to accomplishing this mapping~     will be determining the feasibility of a humanoid robot interacting with a patient in a more~     intuitive and flexible way, while concomitantly investigating the issue of safe contact and~     release.~   "
58070|NCT02806830|"~     In this study, ocular discomfort following intravitreal injection in naïve patients will be~     studied, as well as the efficacy of wetting agent (Optive eyewash) to prevent ocular~     discomfort.~   "
58071|NCT02806817|"~     Prospective, randomized, open label, two arms,, phase 0 clinical trial. HER2-negative breast~     cancer patients recently diagnosed will be screened for trial participation.~      A biopsy will be scheduled the week prior to or the same day as the FDG PET.~     Paraffin-embedded tumor samples will be used to evaluate the stainings of Ki67, cleaved~     caspase-3 and microvessels, and frozen tumor samples will be used to evaluate SDH staining.~      The FDG-PET will be followed by the bevacizumab dose (15 mg/kg IV, single dose). After one~     week, the PET will be repeated in order to detect the patients that have experienced FDG~     uptake decay.~      Right after, treatment with ME-344 (arm 1) or no treatment (arm 2) will start. ME-344 will be~     administered at 10 mg/kg on day 8, 15 and 22. Surgery will be performed on day 28 (thus, 4~     weeks after the bevacizumab dose, which is considered a safe window for antiangiogenics).~      Fragments of the surgical specimen will be collected. Paraffin-embedded tumor sample will be~     used to repeat (and compare) the stainings of Ki67, cleaved caspase-3 and microvessels, and~     frozen tumor sample will be used to repeat (and compare) SDH staining.~      Patients will come off trial in case of consent withdrawal, unequivocal disease progression~     is observed, unacceptable toxicity occurs, or in case of intercurrent disease or any other~     condition deemed incompatible with continuation in the clinical trial by the investigator.~   "
58072|NCT02806804|"~     This study evaluates the safety and immunogenicity of the quadrivalent influenza virus~     vaccine in healthy people aged years 3-60.Subjects will be randomly divided into 3~     groups,receiving the test vaccine, commercially available trivalent influenza vaccine and~     trivalent influenza vaccine containing new influenza B component respectively. Each group has~     800 subjects,2400 in total.~   "
58073|NCT02806791|"~     The endogenous growth factor granulocyte (G-CSF) stimulates the proliferation and~     differentiation of hematopoietic progenitors commissioned to mature as neutrophils and~     activated granulocytes mature neutrophils. In the field of hematology oncology G-CSF it is~     used to reduce the duration and complications of chemotherapy-induced neutropenia and to~     stimulate the mobilization and subsequent collection of circulating hematopoietic stem cells~     in order to use them for autologous transplantation procedure.~      Filgrastim and Lenograstim originator are marketed for many years and are considered the~     reference molecules for the production of biosimilar.~      For several years it is available and entered into common clinical practice the use of~     filgrastim biosimilar (Bio-GCSF) in treating the patient oncohematologic.~      Aim of the study is to analyze retrospectively a large series of patients and assess the~     impacts of the Bio-GCSF on the collection of hematopoietic stem cells and recovery of blood~     counts post autologous transplantation; the data will be compared with a historical cohort of~     reference that has been treated with G-CSF originator.~      The study results will not generate any diagnostic or therapeutic intervention in patients~     still alive.~   "
58074|NCT02806778|"~     The use of protective ventilation (to maintain normoxia and normocapnia), optimise~     haemodynamics, diagnose/treat seizures, therapeutic hypotermia etc is recommended for ICU~     management of patients who have had cardiac arrest and remain in coma after return of~     spontaneous circulation according to the latest International Guidelines. These actions~     essentially aim to limit secondary brain injury but despite all therapeutic effort, the~     cerebral oxygenation may remain inadequate and there is no validated method to avoid such a~     state in real time.~   "
58075|NCT02806765|"~     The purpose of this study is to determine whether specific nutrient supplementation can~     improve dynamic stability in older adults.~   "
58076|NCT02806752|"~     The purpose of this study is to evaluate the effects and safety of ranibizumab therapy~     combined with TA versus ranibizumab monotherapy in patients with polypoidal choroidal~     vasculopathy (PCV). Furthermore, the pharmacogenetics effect of inflammatory related genes~     polymorphism in response to the treatments. To further confirm the role of inflammatory~     factors in the pathogenesis and advance of PCV.~   "
58077|NCT02806739|"~     The purpose of this study is to assess the feasibility of randomizing pregnant women at high~     risk for gestational diabetes to a 24-week period of soy food consumption. This study will~     also examine the effects of soy protein and isoflavones on glucose metabolism and lipid~     levels among pregnant women at high risk for gestational diabetes, and on child's weight and~     height at birth and 6 weeks of life.~   "
58078|NCT02806713|"~     Randomized clinical trial using phenazopyridine to decrease voiding dysfunction after a~     retropubic midurethral sling operation.~   "
70621|NCT02642588|"~     Women in active labor will be given energy gel at 45-60 minute intervals and their fatigue~     level will be compared to women receiving usual practice care i.e. clear liquids only.~   "
58079|NCT02806700|"~     Twitter use is surprisingly well represented across broad demographic population segments and~     health-related messages. The promise of using Twitter is that its use is growing rapidly, it~     allows the investigators to view communications that were impossible to intercept before, and~     it potentially provides information faster and less expensively than collection from other~     media channels. Prior work also supports that social media interventions can improve health~     behavior change (e.g. weight loss, physical activity) and outcomes.The overarching goals of~     this proposal are to understand the uses and limitations of this communication channel to~     improve patients' ability to manage their CV health condition.~   "
58080|NCT02806687|"~     Pancreatic ductal adenocarcinoma (PDAC) is the fifth leading cause of cancer-related death in~     Western countries, and its incidence has increased over the last 40 years. Curative surgery~     to manage PDAC is possible in only a fraction of patients; indeed, a vast majority (85%) of~     patients is diagnosed with locally advanced tumors and/or metastases because they lack~     specific symptoms and early markers for this disease. For these patients, palliative~     armamentarium consists of conventional chemotherapeutic agents such as Gemcitabine and, more~     recently, FOLFIRINOX, which offer marginal survival benefits. Consequently, the prognosis for~     PDAC is still very poor and there is great need for new treatments that can change this poor~     outcome. In this context, the investigators have devised, in the past few years, a highly~     innovative approach based on therapeutic gene transfer, which does not rely on a specific~     genetic and/or cellular background to inhibit PDAC tumor growth. the investigators found that~     SSTR2 and DCK::UMK gene transfer demonstrated complementary therapeutic effects to inhibit~     tumor progression and dissemination, and reduced tumor burden, respectively. On the basis of~     these promising preclinical data, the investigators conducted past three years the first~     clinical study of non-viral vector-mediated therapeutic gene delivery, guided by endoscopy~     (EUS), and combined with standard Gemcitabine therapy in patients with locally advanced and~     metastatic PDAC. The phase 1 demonstrated that the gene-therapy product CYL-02 is expressed~     in PDAC tumors (with long-lasting expression within tumor tissues), is distributed within the~     bloodstream in some extent, when combined with Gemcitabine it can inhibit primary-tumor~     progression and dissemination. Our results tend to demonstrate therapeutic efficacy,~     especially in patients with locally advanced tumors. Based on these encouraging results, the~     investigators propose that patients with locally advanced PDAC at the time of diagnosis may~     clinically benefit from this approach.~      This phase II study is designed to compare the efficacy of intra-tumoral gene delivery of~     CYL-02 plus Gemcitabine treatment or Gemcitabine alone in patient with locally advanced PDAC.~   "
58081|NCT02806674|"~     Approximately 50% of people in the world are infected with H. pylori, and its eradication~     rate fail to exceed 80% and even fails into an unacceptable range.Various risk factors for~     infection include lower socioeconomic status, younger age, and geographic location.In the~     present study, investigators aimed to perform a prevalence survey about risk factors for H.~     pylori infection.To obtain the higher eradication of H. pylori and find out the relevance~     between the diverse infection and clinical drug focused on refractory H. pylori infection.~   "
58082|NCT02806661|"~     Through comparative observation of robot vagus nerve preserving distal gastric cancer radical~     surgery and conventional robot distal gastric cancer radical surgery (not reserved vagus~     nerve) operative and postoperative indicators, and evaluating the feasibility and safety of~     vagus nerve preserving distal gastric cancer radical surgery in advanced gastric cancer.~     Which can provide the evidences for the clinical development of the preserving function~     gastric cancer surgery.~   "
58083|NCT02806648|"~     A phase II trial to assess the activity and safety of PD0332991 in patients with well- and~     moderately-differentiated metastatic pancreatic neuroendocrine tumors (pNET) with~     overexpression of cell cycle markers (Cdk4 and/or phospho-Rb1 and/or cyclin D1)~   "
58084|NCT02806635|"~     This study investigates the effectiveness of www.OurRelationship.com, which provides~     self-help, web-based programs to improve romantic relationships and related outcomes. Couples~     will be randomly assigned to complete the OurRelationship program, the PREP Online program,~     or a wait-list control group and followed for six months.~   "
58085|NCT02806622|"~     The purpose of this study is to compare hip passive range of motion (ROM) among division II~     collegiate athletes in order to obtain normative data for future research. The investigators~     hypothesize that there will be a difference in passive hip ROM among the different genders~     and sports.~   "
58086|NCT02806609|"~     Objective: To evaluate the effect of cold water immersion in elayed onset muscle soreness,~     muscle recruitment, dynamic postural control and quality of sleep in young soccer players.~      Methods: The sample will consist of 28 soccer players between 18 and 21 years of the same~     football club and with the same routine practices and games. At first athletes will respond~     to the IC and will be submitted to the test of a repetition maximum. After three days the~     athletes will analysis of muscle recruitment by electromyography and dynamic posture control~     through the force platform both during the time of shooting, moreover, will respond to scale~     the quality of sleep the previous night and one on pain, then they are instructed to perform~     a fatigue protocol for the quadriceps and then will be randomized to one of four intervention~     groups: cold water immersion, submersion in water at room temperature, or active recovery~     control. The same APPRAISAL be remade into three new moments, 24, 48 and 72 hours after the~     fatigue test.~      Hypothesis: The variables will be considered: Pain intensity in the quadriceps muscle,~     quality of sleep the night after intervention protocol, electromyographic analysis of the~     rectus femoris, vastus medialis oblique and vastus lateralis at the time of shooting, as well~     as postural control when the shot off.~      It is intended to establish the best way of recovery of late quadriceps muscle pain and~     contribute to the clinical practice of active recovery or rest in young soccer players.~   "
58087|NCT02806596|"~     This prospective study aimed to determine the minimal level of Bispectral index needed for~     quality laryngoscopy before ear, nose and throat surgery in children.~   "
58101|NCT02806414|"~     This study will assess the role of topical Ivermectin 1% cream and its effect on protease and~     antimicrobial peptide expression in rosacea. This is a single-site 16-week open label study~     at University of California, San Diego. The investigators will do this by first measuring~     serine protease activity and cathelicidin of all subjects. All subjects will receive~     Ivermectin topical cream and will be instructed on how to apply it daily for 12 weeks.~     Participants will return for monthly visits during which their clinical symptoms of facial~     redness and number of facial papules will be scored, and they will have repeat tape~     stripping. At the end of the study, tape strips will be analyzed to determine serine protease~     activity of participants at each of their visits and expression of cathelicidin (LL-37) mRNA.~     The investigators will then look at changes in serine protease activity and LL-37 expression~     over time, and they will also determine whether or not these changes correlate with disease~     severity.~   "
58102|NCT02806401|"~     The purpose of this prospective randomized study was to compare landmark-subclavian venous~     access to ultrasound-guided axillary venous access when performed by pediatric~     anesthesiologists.~   "
58088|NCT02806583|"~     Caring for people with dementia (PwD) at home requires an enormous amount of time,~     organization and commitment. Therefore, informal caregivers (ICs), mainly relatives, of PwD~     often feel a high burden. Even though support groups on-site have shown positive effects on~     the subjective well-being and on the perceived social support of ICs, relatives either have~     no time or opportunity to leave the PwD alone or there are no support groups in the vicinity.~     The Talking Time project therefore aims to close this supply gap by providing structured~     telephone-based support groups in Germany for the first time. International studies have~     shown resulting benefits for ICs.~      Methods/Design: The project will be evaluated in a cluster adjusted randomized controlled~     trial. The effects of the 3-months Talking Time intervention will be compared to a normal~     care group. Outcomes will be measured at two different times (baseline = T0, after 3 months~     =T1). The control group will receive the Talking Time intervention after T1.~      ICs are eligible if they are 18 or older, have cared for the PwD for at least four hours on~     four days per week in the last six months. Exclusion criteria are psychiatric disorders of~     the IC.~      Primary outcome of the effectiveness elevation is the subjective well-being of the relatives~     measured by the mental component of the SF-12. Secondary outcomes are the physical component~     summary of the SF-12, the Perceived Social Support Caregiver Scale, the Caregiver Reaction~     Scale and the Neuropsychiatric Inventory. For the process evaluation different quantitative~     and qualitative data sources will be collected addressing reach, fidelity, and dosage.~   "
58089|NCT02806570|"~     This is a multi-center, non-randomized, prospective Early Feasibility Study to evaluate the~     AccuCinch® Ventricular Repair System in patients with symptomatic heart failure and~     concomitant functional mitral regurgitation that have stable symptoms on guideline-directed~     medical therapy~   "
58090|NCT02806557|"~     The purpose of this trial is to observe the changes in white cell counts in patients with~     cancer during chemotherapy and to determine if changes in the white cell count in the early~     days during chemotherapy can be used as a predictor of severe neutropenia and its~     complications.~   "
58091|NCT02806544|"~     This study evaluates the feasibility and efficacy of neoadjuvant tamoxifen for patients with~     locally advanced hormone receptor positive breast cancer in a low/middle income country.~   "
58092|NCT02806531|"~     This phase IV clinical study evaluates the safety of enterovirus 71 vaccine in children aged~     6-35 months old by the method of both passive and active surveillance.~   "
58093|NCT02806518|"~     Dynamic infrared thermography (DIRT) is an imaging method that does not require ionizing~     radiation or contrast injection. The study evaluates if DIRT can be an alternative to~     computed tomographic angiography (CTA) in perforator mapping. DIRT findings are compared with~     hand-held Doppler, CTA and intraoperative findings.~   "
58094|NCT02806505|"~     This study evaluated the safety and efficacy of peginterferon alfa-2a monotherapy in~     participants with Chronic Hepatitis C (CHC) who have End-Stage Renal Disease (ESRD) and were~     undergoing hemodialysis.~   "
58095|NCT02806492|"~     The purpose of this study is to determine whether cerebral blood flow and cerebral tissue~     oxygenation is most dependent on cardiac output or on mean arterial pressure in patients~     undergoing cardiac surgery with the use of cardiopulmonary bypass.~   "
58096|NCT02806479|"~     This study evaluates mechanisms of arrhythmogenicity in hypertrophic cardiomyopathy, in~     comparison to patients with well-understood arrhythmogenic substrate (ischemic~     cardiomyopathy), as well as to individuals free from arrhythmogenic substrate~   "
58097|NCT02806466|"~     -  Background: Asthma is a frequent disease characterized by bronchial hyperresponsiveness,~          inflammation and remodeling. Consistent epidemiological data indicate that outcome of~          asthma in adults may be determined in early childhood. This may be due to bronchial~          remodeling, an abnormal repair process that contributes to the development of poorly~          reversible airway narrowing. It appears very early in the natural history of the disease~          and involves increased mass of bronchial smooth muscle (BSM). The mechanism of such an~          increase has been related with an increase in smooth muscle cell proliferation.~          Recently, we have demonstrated that in severe asthma, BSM increased proliferation is~          induced by an enhanced mitochondrial biogenesis. Moreover, we have also shown that~          immature human, non-asthmatic airway smooth muscle cells (ASMC) proliferate to a greater~          extent than normal adult ASMC, in a similar fashion to adult asthmatic ASMC. Immature~          ASMC may thus have great potential to stimulate airway remodeling. We thus hypothesized~          that remodeling is an early process and certain characteristics of ASMC in severe~          preschool asthma may predispose such children to persistent remodeling with airway~          obstruction later in life.~        -  Purpose: To investigate prognostic factors of airway remodeling in preschool children,~          with special attention to ASMC proliferation (mitochondrial mass & biogenesis).~        -  Methods: In the initial phase of the project, 75 severe asthmatic preschool children (<5~          yr) will be prospectively recruited from the CHU de Bordeaux and the CHU de Toulouse~          according to the Haute Autorité de Santé criteria. Inclusion visit will include~          written informed consent, asthma control evaluation, clinical examination, lung function~          testing (exhaled NO, plethysmography), prick tests, chest X Ray and blood sample for~          total IgE levels. Bronchial specimens from all subjects will be obtained by fiberoptic~          bronchoscopy at visit 2. Airway remodeling will be evaluated by morphological analysis.~          After smooth muscle mitochondria will be analyzed by electronic microscopy &~          immunoblotting. Comparison between the 2 groups will be performed by unpaired t tests~          for parametric data and x2-tests for non-parametric data. In the second phase of the~          project, patients will then be followed-up till the age of 7-10 yrs, when another~          bronchoscopy with biopsies will be performed.~   "
58098|NCT02806453|"~     A randomized controlled cross-over trial in full-term infants affected by symptoms suggestive~     of GER, evaluated through a validated questionnaire (Infant Gastroesophageal Reflux~     Questionnaire Revised).~      The parents of all of the enrolled infants will be reassured on the benign nature of the~     condition and will advise to apply lifestyle changes for one week.~      Than, the patients will be randomized into one of the two sequence treatment groups. (group~     A: Mg alginate/thickened formula; group B: thickened formula/Mg alginate) for two weeks.~     Evaluation of symptom scores will be performed at day 0, day 7, day 21 and day 35.~   "
58099|NCT02806440|"~     This study evaluates the effect and mechanism of low dose naltrexone for treatment of pain in~     patients with fibromyalgia. It s a randomised, double-blinded, placebo-controlled, cross-over~     study.~      It is a 2-center study that takes place at The Multidisciplinary Pain Center in Copenhagen~     and at The Multidisciplinary Pain Center in Give.~   "
58100|NCT02806427|"~     This prospective observational study seeks to demonstrate the ability to meet nutritional~     needs of a calorically dense enteral formula in critically ill patients.~   "
58103|NCT02806388|"~     This study aims to screen tumor molecular profile for better selection of anticancer~     treatment, in particular, allocation to clinical trials if available.~   "
58248|NCT02804464|"~     Demonstrate that the Karius Infectious Disease Diagnostic Sequencing Assay performed on~     plasma can accurately detect the microbiologic etiology in febrile allogeneic stem-cell~     transplant patients when compared with standard clinical diagnostics~   "
58104|NCT02806375|"~     A number of groups have demonstrated very low incidence of acute and chronic~     graft-versus-host disease (GVHD) with post-transplantation cyclophosphamide (PTCy) in~     haploidentical and unrelated allogeneic stem cell transplantation (SCT). Still the relapse of~     the underlining malignancy is a problem after this prophylaxis. Ruxolitinib is currently one~     of the most promising drugs in the treatment of steroid-refractory GVHD. On the other hand,~     its primary indication is myelofibrosis, and it was demonstrated that ruxolitinib before~     allogeneic SCT might improve the outcome. This pilot trial evaluates whether the combination~     of PTCy and ruxolitinib facilitates adequate GVHD control, and decreases the risk of graft~     failure and disease progression in myelofibrosis patients.~   "
58105|NCT02806362|"~     The purpose of this multicenter, single-arm, combination-drug study, which includes 12 weeks~     of treatment and 24 weeks of follow-up, is to evaluate the safety, efficacy and~     pharmacokinetics of ombitasvir/paritaprevir/ritonavir in Japanese adults infected with HCV~     GT1b, who are treatment-naïve or treatment-experienced to an IFN-based regimen and who have~     ESRD on HD.~   "
58106|NCT02806349|"~     The purpose of this study was to determine whether the co-administration of a~     konjac-glucomannan fibre blend and American ginseng in a randomized, placebo-controlled,~     cross-over trial can improve diabetes management.~   "
58107|NCT02806336|"~     Obesity is a major risk factor for mobility problems in older adults and many older adults~     use a walking aid to help with their mobility. The use of a walking aid changes normal~     walking patterns and makes walking harder, leading people to have more functional problems.~     The purpose of this study is to test the effects of 12 months of a multi-modal balance~     intervention (MMBI) with supervised weight loss compared to MMBI only on fitness, functional~     performance, balance, and economy of gait. Participants will be one of 120 participants in~     the VAMHCS. Participation in this study is voluntary. The research will be conducted at the~     VAMHCS. The entire study will take approximately 4 years to complete. Subjects' participation~     in the study will last 24 months.~   "
58108|NCT02806323|"~     The goal of this pilot study is to determine the feasibility of an individually tailored yoga~     program delivered in a group setting for the treatment of chronic neck and back pain in a low~     income population. Chronic pain is one of the most common, costly, and disabling conditions,~     and is often refractory to treatment. Yoga is a promising treatment for chronic pain. This~     pilot study will test the hypothesis that study subjects will participate in a voluntary 12~     week yoga intervention for the treatment of chronic neck and back pain, as assessed by~     attendance at 12 weekly yoga practice sessions. Secondary outcomes will include change in~     pain and quality of life scores over the 12 week study period as assessed by the Visual~     Analog Scale for Pain Severity and EQ-5D-3L.~   "
58109|NCT02806310|"~     Bicuspid Aortic Valve (BAV) disease is a common cardiac anomaly that is associated with~     valvular abnormalities, both stenosis and regurgitation, and aortopathy. It is also shown to~     play role in abnormal aortic distensibility and stiffness with impairment of aortic~     elasticity and Left ventricular dysfunction. Mechanism of aortopathy is complex and is not~     understood completely. In a recent study podocan is found in extracellular matrix (ECM) of~     human aorta and is found to be accumulated in human abdominal aortic aneurysms. There is no~     current effective therapy that can alter the progression of aortic dilatation in bicuspid~     valve disease. Aortic surgery and aortoplasty is the only treatment in severely dilated aorta~     and aortic dissection. In this study the aim is to investigate the association between~     podocan and Wnt pathway in development and pathogenesis of aortopathy. This could provide~     more effective and physiological understanding of disease process and potential target in~     prevention and treatment for aortopathy.~   "
58110|NCT02806297|"~     Randomized trial of laparoscopic cholecystectomy with cholangiogram on admission versus after~     resolution of pain for mild gallstone pancreatitis.~   "
58111|NCT02806284|"~     The purpose of this study is to determine wether skull trauma or neurosurgery affect the~     immune response to two vaccine types.~   "
58112|NCT02806271|"~     Worry postponement is a commonly recommended treatment component in cognitive behavioral~     therapy for Generalized Anxiety Disorder in which people are asked to postpone naturally~     occurring instances of worry to a designated 30 minute worry period later in the day.~     Despite being commonly recommended, there is little known about the efficacy and mechanisms~     of worry postponement. The purpose of this study is to determine the efficacy and mechanisms~     of change of a two-week worry postponement intervention in people with Generalized Anxiety~     Disorder. Ninety subjects with generalized anxiety disorder will be randomly assigned to two~     weeks of daily worry postponement, two weeks of worry monitoring, or an assessment only~     control condition. Changes in worry or associated features will be examined at post~     intervention and at a 2-week follow up.~   "
58113|NCT02806258|"~     In the NeoAPBI 01 trial, the objective is to demonstrate the efficacy of combined APBI and CT~     administered sequentially in patients with intermediate ad high risk BC. The hypothesis is~     that combined PST-sequential APBI may increase the rate of pCR, breast conservation and~     survival without additional toxicity, as seen with WBI~   "
58114|NCT02806245|"~     Surgery with cardiopulmonary bypass (CPB) for congenital heart disease (CHD) causes low~     cardiac index (CI). With the increasing success of surgery for CHD, mortality has decreased~     and emphasis has shifted to post-operative morbidity and recovery. Children with CHD~     undergoing surgery with CPB can experience well-characterized post-operative cardiac~     dysfunction. When severe, patients can develop clinically important low cardiac output~     syndrome (LCOS) and hemodynamic instability. Management of LCOS and hemodynamic compromise is~     primarily accomplished via intravenous durgs like milrinone, dopamine or dobutamine, which~     affect the strength of the heart's muscular contractions. These are used to maintain adequate~     blood pressure (BP) and CI. However, inotropic agents are potentially detrimental to~     myocardial function and may increase risk for post-operative arrhythmia and impair~     post-operative recovery by increasing oxygen demand and myocardial oxygen consumption (VO2).~     In combination with the increased VO2 associated with CPB-induced systemic inflammatory~     response patients can develop a critical mismatch between oxygen supply and demand,~     essentially the definition of LCOS. Therefore, therapies that improve CI and hemodynamic~     stability without increased VO2 are beneficial. This study will test whether BiVp, a~     specialized yet simple pacing technique, can improve post-operative CI and recovery in~     infants with electro-mechanical dyssynchrony (EMD) after CHD surgery. This study hypothesizes~     that Continuous BiVp increases the mean change in CI from baseline to 72 hours in infants~     with EMD following CHD surgery compared to standard care alone.~   "
58117|NCT02806206|"~     Small bowel capsule endoscopy is a test used to investigate for any abnormalities in the~     small bowel. The small bowel is about 4 meters long. The battery time of the capsule is about~     8 hours. During this time the capsule takes pictures as it passes through the small bowel. In~     about 15-20% of capsule tests the battery expires before the capsule passes through the~     entire small bowel into the colon. Incomplete tests indicate that a variable portion of small~     bowel was not visualized. Incomplete tests are associated with potential missing of~     abnormalities in the portion of small bowel that was not reached. The capsule test may often~     required to be repeated but the problem of incomplete examination may persist. At present no~     medication has been approved to increase the rate of complete capsule tests.~      Prucalopride is a medication that has been approved in Canada and Europe for the treatment of~     chronic idiopathic constipation. Animal and human studies suggested that prucalopride may~     enhance the movement of the stomach and the small bowel. A recent presentation at a medical~     meeting suggested that prucalopride may accelerate the passage of the capsule camera through~     the small bowel without increasing the chance to miss a lesion in the small bowel.~      The purpose of this study is to asses if the administration of a single dose of prucalopride~     is going to decrease the time required by the capsule to move through the small bowel.~   "
58118|NCT02806193|"~     The Global CMR Registry aims to promote collaboration of CMR sites worldwide in setting~     imaging and reporting standards, assessing its diagnostic impact on patient care, and~     determining the cost-effectiveness of CMR imaging. It will be the largest collective body of~     evidence reflecting the current clinical applications in patient care, which healthcare~     payers and governing bodies alike can depend on when metrics such as testing appropriateness,~     common indications, and diagnostic effectiveness are called for. It will also be able to~     reflect any changes in patient impact from CMR over time as technical development evolves.~     Furthermore, it will allow an assessment of improvements in diagnostic and therapeutic~     thinking, risk stratification, and cost-effectiveness relevant to current patient management.~   "
58119|NCT02806180|"~     This is a randomized controlled trial comparing the success of US guided peripheral IV~     placement between single vs dual-operator technique among a convenience sample of patients~     with moderate or difficult vascular access in a tertiary care Emergency Department.~   "
58120|NCT02806167|"~     Expedient diagnosis and management of acute cauda equina syndrome (CES) is essential to~     prevent long-term neurological sequelae for these patients. The clinical diagnosis of CES is~     confirmed using magnetic resonance imaging (MRI). However the clinical features of CES~     (secondary to bladder and bowel sphincter dysfunction) are variable and are common presenting~     features of other pathologies of the bladder and bowel, therefore most patients who undergo~     MRI for suspected CES have no compressive lesion evident on the MRI, excluding the diagnosis~     of CES. Urgent MRI scanning performed out of hours is therefore often unnecessary, however,~     the morbidity to the patient due to a delay in diagnosis is so significant that urgent MRI~     scanning is the current gold standard and duty of care in all cases of suspected CES. More~     objective methods of assessing patients with suspected acute CES could allow rationing of out~     of hours MRI scanning and reduce inappropriate admission without impacting patient safety.~      The aim of this study is to evaluate the effectiveness of a clinical algorithm which utilises~     digital rectal examination and ultrasound bladder scanning to stratify patients into high and~     low risk groups. Patients considered high risk will be admitted and sent for urgent MRI,~     whereas low risk patients will be discharged and undergo MRI scan within 5 days of~     presentation.~   "
58121|NCT02806154|"~     The investigators could hypothesize that age-related changes in body composition parameters~     play a role in the variable tolerance to chemotherapy in the elderly.~      However none of the studies relating body composition and chemotoxicity included elderly as a~     specific subpopulation. Furthermore in the majority of studies, body composition analyses are~     based on the estimation of muscle mass by CT scanner (axial L3 section). This method is to~     date not validated in the elderly cancer patients. Nevertheless some studies used Dual Energy~     X-ray Absorptiometry (DEXA), which is considered the gold standard in the assessment of body~     composition in older adults.~      The investigators main hypothesis is that the appendicular muscle mass (I.e. muscle mass of~     the 4 limbs) operationalized as an index by dividing the muscle mass by squared height~     following Baumgartners' approach (Baumgartner, 1998) measured by DEXA (total of muscle mass~     of 4 limbs / height ²) represents a predictive factor of chemotoxicity in the elderly.~      The finding that body composition is associated with poor tolerance of chemotherapy could~     lead to consider these parameters in the treatment decision of the elderly cancer patients~     and improve the current decision-making algorithms when treating older adults.~   "
58122|NCT02806141|"~     This study is planned to compare the clinical efficacy and safety of aerosolized plus~     intravenous colistin vs. intravenous colistin as adjunctive therapy for the treatment of~     ventilator-associated pneumonia (VAP) due to pandrugs-resistant (PDR) Acinetobacter baumannii~     in the neonates.~   "
58123|NCT02806128|"~     Evaluate the effectiveness of the of kallikrein in the different drug frequency for acute~     anterior circulation cerebral infarction.~   "
58124|NCT02806115|"~     Investigators found that the degree and the duration of aceto-whitening differed between~     gastric intestinal metaplasia(GIM) and the surrounding normal mucosa: the area of GIM showed~     a severe degree of aceto whiteness and the whitening continued longer than the surrounding~     normal mucosa, which investigators called severe whitening and delayed fading, and~     investigators realized that GIM could possibly be diagnosed by using these differences.The~     aim of this prospective study was to investigate the efficacy of severe whitening and~     delayed fading for diagnosing GIM.~   "
58125|NCT02806102|"~     This study is intended to provide contemporary data on the residual cardiovascular risk in~     all consecutive patients with acute myocardial infarction, especially in patients who~     survived stably within one-year after percutaneous coronary intervention.~      In addition, this study will identify which baseline clinical, angiographic, or treatment~     factors are associated with residual cardiovascular risk and bleeding events~   "
58126|NCT02806089|"~     Aim of this study is to determine in chronic kidney disease patients:~        -  the involvement of malnutrition inflammation and atherogenesis syndrome (increase in C~          reactive protein and decrease in serum albumin) on voluntary muscle strength impairment~        -  the relationship between voluntary muscle strength and muscle mass~        -  the relationship between voluntary muscle strength and lean body mass~        -  the correlation between voluntary muscle strength and physical activity~   "
58128|NCT02806063|"~     Chronic prosthetic joint infection (PJI) is a devastating complication of arthroplasty and~     its treatment continues to fuel the debate on how to manage it appropriately.~      One stage and two stage exchange surgery both are the conventional surgical procedures for~     chronic PJI commonly used to date.~      Two stage surgery disadvantages (major surgery, anesthesia and nosocomial risks, functional~     impairment between surgeries and a high socio-economic coast) encouraged many surgical teams~     to adopt one stage exchange surgery which provides equivalent or better outcomes. However one~     stage surgery encounters a major conceptual difficulty when it comes to implant the new~     prosthesis in a surgical site microbiologically undetermined and potentially contaminated.~      Investigators suppose the new prosthesis is implanted in a contaminated setting regardless of~     bacteria type and antibiotic therapy duration before arthroplasty.~      The total lack of data answering this question motivated the conception of this prospective~     study in order to describe the microbiological setting where is implanted the new prosthesis~     with one stage exchange surgery after surgical excision and antibiotic therapy initiation in~     chronic PJI.~   "
58129|NCT02806050|"~     The purpose is to evaluate whether non invasive in vivo imaging of the estrogen receptor (ER)~     presence in metastatic breast cancer patient by means of 18F-fluoro-estradiol (FES) positron~     emission tomography (PET) can be used to predict treatment response to palbociclib plus~     letrozole. As ER expression predicts response to palbociclib in metastatic breast cancer~     patients the investigators hypothesize that lesions with low uptake on FES-PET will not~     respond to the combination of letrozole plus palbociclib.~   "
58130|NCT02806037|"~     Intraoperatively, the surgeon will interrogate the liver with ultrasound. The time spent by~     the surgeon using the ultrasound is recorded. If all lesions seen on pre-op imaging were~     found, the patient does not have the Pathfinder Explorer system applied. If one or more~     lesions cannot be found, then the Pathfinder Explorer system is calibrated and a tracking~     device is attached to the ultrasound probe, which the surgeon will use to reattempt~     localization of the missing tumor. The Pathfinder Explorer system operates in real-time in~     conjunction with the ultrasound.~   "
58131|NCT02806024|"~     The purpose of this pilot study is to determine if intravenous tranexamic acid (TXA) is~     effective for reducing blood loss during high risk surgical procedures related to placenta~     previa and placenta accreta. TXA is currently used in other types of surgery for patients who~     are expected to have a large blood loss, such as orthopedic or open heart surgery.~   "
58132|NCT02806011|"~     This is a 5-year (+30 days) long term follow up study to evaluate the safety of Livercellgram~     in subject who participated in and completed the Livercellgram Phase 2 trials (refer to~     ClinicalTrials.gov.Identifier: NCT01875081).~      This trial is planned to evaluate the safety of Livercellgram in patients with alcoholic~     liver cirrhosis. Subjects who signed this follow-up observation informed consent form will~     participate in a safety assessment (tumor marker test, occurrence of adverse events and~     serious adverse events, clinical laboratory tests, vital sign, physical examinations.).~   "
58133|NCT02805998|"~     The overarching goal is to utilize a randomized control design to examine efficacy of~     web-based cognitive behavior therapy (CBT-I) plus treatment as usual compared to treatment as~     usual alone for insomnia and depression outcomes among pregnant women with insomnia at high~     risk for depressive relapse/recurrence (n=208).~   "
58134|NCT02805985|"~     This study is a post-market clinical follow-up study. A post-market, prospective clinical~     trial will be conducted. The data collected from this study will serve the purpose of~     confirming safety and performance of the FLXfit™ implant.~   "
58135|NCT02805972|"~     The purpose of this study is to understand how the opioid system is involved in eating~     behavior.~   "
58136|NCT02805959|"~     To study the motility of the bowel in constipated patients. Looking at the difference between~     young and elderly patients with constipation.~   "
58137|NCT02805946|"~     This study evaluates the the pharmacokinetics of posaconazole (new solid oral and IV) given~     as prophylaxis to patients who are at risk for developing fungal infections after receiving~     conditioning therapy (except strictly non-myeloablative (NMA)) for allogeneic Stem Cell~     Transplant (SCT), remission induction chemotherapy for acute myeloid leukemia (AML) or myelo~     dysplastic syndrome (MDS) or being treated for severe graft versus host disease (GvHD) and~     determines the impact of mucositis on the pharmacokinetics of posaconazole new solid oral.~   "
58138|NCT02805920|"~     Adductor canal block (ACB) is a new technique gaining acceptance as an alternative analgesic~     method of femoral nerve block (FNB) following knee surgery. The advantage of ACB is its~     dominant sensory nerve block effect. It preserves quadriceps muscle strength compared with~     the FNB. This will serve as potential gain for early rehabilitation and thereby functional~     outcome. Adequate direct injection of local anesthetic into the canal will block four nerves:~     the saphenous nerve, the nerve to the vastus medialis, the medial femoral cutaneous nerve,~     and the terminal end of the posterior division of the obturator nerve. Anterior cruciate~     ligament reconstruction (ACLR) is often associated with postoperative severe pain.~     Postoperative early rehabilitation is the primary focus to restore pre-injury status and is~     an essential part of the full recovery, especially that this rehabilitation extents over a 6~     month period. Early elimination of pain is necessary to achieve this goal. However, there are~     no clear conclusive clinical reports defining the adequate analgesic volume-dosage of local~     anesthetic for ACB for postoperative ACL pain management. The investigators speculated that~     volume-dosage manipulation play key role in the effective of ACB for postoperative pain. The~     investigators conducted this prospective, randomized, observer-blinded trial to compare 3~     combinations of volume and dosage of 0.25 % bupivacaine for US-guided ACB. The first aim of~     the investigation is to compare the analgesic effect of ACB 0.25% bupivacaine of the 3 doses~     as assessed by the visual analog scale (VAS) pain scores. The second aim were duration of~     analgesia, as defined by first demand for analgesia, and subsequent 24-h consumption.~     Physiotherapy tolerance and time to discharge were evaluated. Side effects were also~     assessed.~   "
58243|NCT02804529|"~     The Palmer's point and periumbilical region are the common laparoscopic entry site to~     establish the pneumoperitoneum. In the present study, the investigators assess the safety and~     feasibility of Meng's point as a new laparoscopic entry site in cases to perform the~     gastrointestinal surgery.~      This prospective and randomized study will compare the three entry techniques with regard to:~        -  Complications related to the entry technique~        -  Time taken to enter the abdomen.~        -  The number of attempts taken to enter the abdomen~   "
58139|NCT02805907|"~     Introduction: There are many cross-sectional studies in children and adults indicating that~     low vitamin D levels in asthmatic patients are correlated with poorer asthma control, poorer~     lung function, decreased response to glucocorticoids and more frequent exacerbations.~     Moreover, as there is a significant group of asthmatic patients having insufficient control~     of their disease, despite high doses of inhaled corticosteroids, we have investigated new~     treatment alternatives, which include vitamin~      Objective: To determine the efficacy of vitamin D supplementation in asthmatic patients with~     vitamin D deficiency in degree of asthma control.~      Materials and methods: A prospective, controlled, randomised, triple-blind study was~     conducted with a follow-up of 6 months. The patients recruited were over 18 years of age with~     a medical diagnosis of bronchial asthma and serum 25(OH)D3 levels < 30 ng/ml. Patients were~     excluded if they had a smoking habit ≥ 10 pack-years, taking vitamin D supplements, kidney~     disease (creat. > 2 mg/dl), hypercalcaemia (corrected with proteins > 10.5 mg/dl), a repeat~     episodes of renal colic, any gastrointestinal disease that might interfere with vitamin D~     absorption, or severe psychosocial problems, or were pregnant or breast-feeding. The~     randomisation process assigned patients to one of two groups: a group that received vitamin D~     (in the form of calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral~     route) and another group that received placebo in a presentation with an identical appearance~     and the same administration regimen. Demographic, clinical, spirometry and laboratory~     endpoints were collected. The primary endpoint was degree of asthma control as determined by~     the internationally validated Asthma Control Test (ACT). The secondary endpoints were asthma~     exacerbations, dose of inhaled corticosteroids and quality of life as measured using the~     Mini-AQLQ (Asthma Quality of Life Questionnaire).~   "
58140|NCT02805894|"~     This study is a Phase 1/2 open-label involving 2 groups of patients newly diagnosed with~     either unfavorable intermediate risk or high risk prostate adenocarcinoma. One group will~     receive only EBRT and the other group will receive a Brachytherapy boost and EBRT.Both groups~     will receive treatment with androgen deprivation. There will be 2 consecutive steps, a dose~     escalation and a subsequent dose expansion part.~   "
58141|NCT02805881|"~     Safety and Feasibility of Combined Trigeminal and Occipital Transcutaneous Nerve Stimulation~     (CTO-TNS) in Major Depressive Disorder (MDD)~   "
58142|NCT02805868|"~     The main purpose of this investigational research study is to determine how safe and~     tolerable the study drug siltuximab is in patients with myelofibrosis (MF). This medication~     has been approved by the FDA for another condition (multicentric castleman's disease (MCD),~     but not for myelofibrosis (MF). In MCD, siltuximab resulted in improvement in symptoms and~     anemia. While MCD and MF are different diseases, they share some common features including a~     protein call interleukin-6 (IL-6) that may be important in causing symptoms of MCD and MF.~   "
58143|NCT02805855|"~     The study seeks to determine the safety and feasibility of using adipose-derived mesenchymal~     stromal cells to treat symptoms of mild to severe knee osteoarthritis.~   "
58144|NCT02805842|"~     Aim The primary objective of this study is to compare medication adherence with medical~     therapy in patients receiving once-daily versus twice-daily tacrolimus regimens.~      Participants 60 adult renal transplant patients randomized 1:2 into twice-daily and~     once-daily tacrolimus groups~      Outcomes The primary outcome will be medication adherence to the once-daily and twice-daily~     regimens, measured in terms of implementation. Secondary outcomes will include graft and~     patient survival, renal function and adverse events. Follow up - 12 months~   "
58145|NCT02805829|"~     This trial is to evaluate the safety and effectiveness of activated and expanded in vitro~     autologous NK cells following trastuzumab treatment for patients Human Epidermal Receptor-2~     overexpressing advanced gastric cancer.~   "
58146|NCT02805816|"~     The investigators will perform prospective observational multicenter study which includes~     children with suspicion of CD who referred to gastroscopy and intestinal biopsies (study~     group) and children without suspicion of CD who underwent gastroscopy for other reasons. The~     investigators will compare sensitivity, specificity and predictive values of several~     serological kits of TG2 (tissue transglutaminase) (Bioplex 2200, Bioflash, Phadia 250,~     Liason-XL, Orgentec Alergia and Eurospital) compared with definitive diagnosis of CD~     according to histological findings.~   "
58147|NCT02805803|"~     Prosthetic joint infection (PJI) management is complex and requires prosthesis replacement~     when symptoms duration is greater than 30 days or debridement with modular set replacement~     when symptoms duration is lesser than one month. Nevertheless, the prolonged suppressive~     antibiotherapy (PSA) is the single treatment we can provide to high risk surgical patients~     and those who refuse reoperation.~      There is limited data available on PSA modality, its tolerance and efficacy, this lack of~     data motivated us to concept a prospective study of long term patient follow up with PJI~     treated with prolonged suppressive antibiotherapy.~   "
58148|NCT02805790|"~     This is a Phase 2, randomized, double-blind, placebo-controlled crossover study which will~     enroll up to 36 subjects (anticipated) with genetically confirmed mitochondrial disease who~     have completed participation in the SPIMM-201 (MMPOWER) study. Subjects will be randomized~     (1:1) to one of two sequence groups: 4-weeks of treatment with 40 mg elamipretide~     administered once daily subcutaneously in Treatment Period 1 followed by 4-weeks of treatment~     with placebo administered once daily subcutaneously in Treatment Period 2 (separated by~     4-week washout period), or vice versa~   "
58149|NCT02805751|"~     The purpose of this study is to measure the mechanical properties of the tendon after~     conservative treated Achilles tendon ruptures with or without early controlled loading. This~     is done in a randomized trial and the mechanical properties are measured using roentgen~     stereometric analysis (RSA).~      The hypothesis is that early weightbearing improves mechanical properties of conservative~     treated Achilles tendon ruptures without causing elongation of the tendon.~   "
58150|NCT02805738|"~     A Multicenter, Randomized, Double-blind, Parallel Design, Phase III Clinical Trial to~     Evaluate the Efficacy and Safety of CKD-390 tablet~   "
58151|NCT02805725|"~     Assessment of the efficacy and safety of trabectedin and metronomic cyclophosphamide (CP) in~     patients with advanced pretreated soft-tissue sarcomas, once the Maximum Tolerated Dose (MTD)~     have been determined (phase I trial).~   "
58152|NCT02805712|"~     This small pilot study will be assessing the the impact of a standardized, social-worker led,~     longitudinal palliative care intervention on alignment of patient and physician understanding~     of prognosis and goals of care. Secondary objectives include assessing the impact of this~     intervention on documentation of advanced care planning and end of life preferences, symptom~     burden, quality of life and health care utilization.~   "
58153|NCT02805699|"~     The purpose of this study is to confirm the efficacy and safety of BaofeiKang Granule in the~     treatment of Combined Pulmonary Fibrosis and Emphysema patients.~   "
58154|NCT02805686|"~     The maculopathy induced by the retinal toxicity of the synthetic antimalarials must be~     detected at the infra-clinical state, when it can still be reversible. Identifying early~     retinal anatomical changes has always represented (a challenge for medical interns,~     dermatologists, rheumatologists, and ophthalmologists). Currently, the gold-standard for its~     screening and its diagnostic is the multifocal electroretinogram (mfERG), however it is a~     long and tedious exam, offered by only few medical centers. It is recommended to find a~     simple non-invasive alternative, on a commonly used equipment. The study of the ellipsoid~     (junction line between, the external and internal photoreceptor segments) using optical~     coherence tomography (OCT-SD) en face enables us, to obtain a panoramic viewing of the~     state of the photoreceptor layer, and to detect any modification, even subtle, within this~     layer. The OCT-SD en face can be easily done by any ophthalmologist who owns one.~      The proportion of en face OCT-SD showing suggestive retinal damage and patients who present~     retinal damage in relation with synthetic antimalarial treatments and diagnosed by mfERG is~     considered in this study.~   "
58155|NCT02805673|"~     At present, the literature does not account for much of scientific data on the assessment of~     osteopathic intervention for patients with (Fibromyalgia) FM. The investigators propose a~     pilot study evaluating the efficacy of osteopathic care, consists of several osteopathic~     interventions in the treatment of FM, in order to improve the painful experiences of FM~     patients. This study must include 44 patients with FM according to (American College of~     Rheumatology) ACR criteria and followed the University Hospital of Caen.~      The osteopathic care will last eight months and will be followed by a report three months~     after the end of osteopathic interventions. This in order to evaluate the effect in the short~     term and long term, of osteopathic care in patients with FM.~   "
58156|NCT02805660|"~     Mocetinostat (MGCD0103) is an orally administered HDAC inhibitor. Durvalumab (MEDI4736) is a~     human monoclonal antibody that is an inhibitor of the Programmed Cell Death Ligand (or~     PD-L1). Durvalumab is also known as a checkpoint inhibitor.~      This study is evaluating the combination regimen of mocetinostat and durvalumab in subjects~     with Advanced or Metastatic Solid Tumors and Non-Small Cell Lung Cancer.~      Patients eligible for this study may have previously received treatment with a checkpoint~     inhibitor.~   "
58157|NCT02805647|"~     This study was designed to determine the impact of vitamin D serum levels and vitamin D~     receptor (VDR) polymorphisms on the occurrence of low energy fractures in children.~   "
58158|NCT02805634|"~     The main goal of this study is to determine if the Triple Stimulation Technique (TST) can be~     correlated to performance in the manual dexterity 'nine holes peg' test, within a control~     group and a group of patients with multiple sclerosis.~      TST (Triple stimulation technique) combines two techniques used in neurologic diagnosis:~     magnetic stimulation and electroneuromyography. It is based on the principle of two~     collisions between the descending central stimulation (magnetic stimulation) and the~     ascending peripheric stimulation. TST allows to better quantify central nervous system~     diseases. The abnormal amplitude registered by TST is proportional to the intensity of~     conduction disorders. The evaluation of these disorders is more precise than with the~     magnetic stimulation technique alone.~      The Nine Hole Pegs technique is a simple manual dexterity test, commonly used in ergotherapy.~     The participant tries to place 9 pegs in a 9 holes perforated plate, and then tries to remove~     them as quickly as possible. The hand must stay in a depression within the plate, thereby~     insuring a constant distance between the hand and the pegs.~      The nine hole peg will be realized first, and the triple stimulation examination performed~     after. The acquired data will be analyzed in order to find a correlation between the~     impairment level given by these two tests.~   "
58159|NCT02805621|"~     Demonstrate in a large multicenter population the diagnostic performance of a pre-commercial~     on-site, local, CT angiography derived FFR algorithm in comparison to invasive FFR.~   "
58160|NCT02805608|"~     The sensitivity and specificity of uPAR PET/CT with the radioligand 68GaNOTA-AE105 and FDG~     PET/MRI for preoperative detection of regional lymph node metastases in urinary bladder~     cancer~   "
58161|NCT02805595|"~     This study evaluates the effect of hypertonic saline 23.4% injection in fistulas or sinus~     tracts in adult patients with hidradenitis suppurativa.~   "
58162|NCT02805582|"~     The intercostobrachial nerve underlies many anatomical variations. For surgery of the upper~     arm the axilla is usually not anaesthetized by a brachial plexus block, which therefore needs~     to be completed by an intercostobrachial nerve block. The optimal access for an ultrasound~     guided block of the intercostobrachial nerve is not yet known. The investigators compare a~     proximal and a more distal approach to the nerve referred to onset time, sensory blocked area~     and duration.~   "
58163|NCT02805569|"~     Indirect videolaryngoscopes provide an improved view of the glottis. Unfortunately enhanced~     video blade angulation leads to difficulty in passage of the endotracheal tube (ETT) towards~     the larynx around the steep blade angulation despite adequate visualization of the glottis.~     Pre-shaping the ETT with the rigit malleable stylet is recommended. The investigators~     hypothesized that using articulating stylet (AS) would enhance first attempt intubation,~     shorten the intubation time, reduce the possibility of the soft tissue trauma compared to~     conventional intubation stylet (IS) in patients with difficult airway .~   "
58164|NCT02805556|"~     A phase I absolute bioavailability study of BMS-626529 following oral and intravenous dosing~   "
58165|NCT02805543|"~     Objective: The main target of this study was to research the early changes of retrobulbar and~     intrarenal hemodynamics, then to research the correlation between them in type 2 diabetes~     (T2DM) patients without diabetic kidney disease (DKD) and diabetic retinopathy (DR).~      Method: 35 T2DM patients (diabetes group) without vascular complications and 30 healthy~     people (control group) were recruited to research the early changes of renal function,~     retrobulbar and intrarenal hemodynamics, and then to research the correlation between them.~     The primary endpoints were the intrarenal hemodynamic (bilateral kidney RI) in bilateral~     interlobular renal arteries were evaluated using Doppler Sonographic; the secondary endpoints~     were the retrobulbar hemodynamics RI in the bilateral central retinal artery (CRA), posterior~     ciliary artery (PCA), and arteria ophthalmica (OA) were evaluated using color doppler imaging~     (CDI); the tertiary endpoints were the biochemical endpoints: blood-fat (TC, HDL-C, LDL-C,~     and TG), FPG, 2hPG, HbA1c, and renal function parameters (BUN, Cr, and GFR); in addition, the~     albumin excrete rate (AER), urinary albumin/creatinine ratio (UACR) were measured.~   "
58166|NCT02805530|"~     Non-small cell lung cancer (NSCLC) is the most frequent neoplasm worldwide and also~     represents the main cause of cancer death. However, it represents the main cause of death by~     cancer. The prognosis of survival at 5 years is poor, approximately 13-15%.~      Various studies suggest that patients who clinically present with a limited number of~     metastases, a term defined as oligometastatic disease, could have a better prognosis of~     survival with a radical treatment, than for their counterparts with a greater number of~     metastasis.~      The purpose of this study is to add more information to the current medical literature about~     the benefits in overall survival of radical treatment of oligometastatic disease in patients~     with NSCLC and equal or less than 5 synchronous metastases at the time of diagnosis.~      The outcomes of the study are to determine the global survival and progression-free survival~     in patients with synchronous oligometastatic (equal to or less than 5 sites) advanced NSCLC~     undergoing radical treatment of all metastatic sites and the primary tumor.~   "
58167|NCT02805517|"~     This will be a single-arm prospective internally-controlled study. Patients will undergo~     percutaneous externally-assembled laparoscopic donor nephrectomy where one or more 3 mm~     instruments are added or substituted for conventional 5 or 10 mm trocars. Multiple outcome~     measures (endpoints) will be measured including time to first opioid use, total inpatient~     opioid dosage, patient ranking of painfulness of each port site, duration of ileus, time to~     ambulation, length of hospital stay, presence of any intraoperative or postoperative~     complications, operating time, estimated blood loss, and other routine parameters collected~     in a prospective surgical study~   "
58168|NCT02805504|"~     A prospective, randomized controlled study to determine the efficacy of liposomal bupivacaine~     given by local injection at all the wound sites in patients undergoing urologic surgeries.~   "
58169|NCT02805491|"~     Hypospadias is the most frequent malformation of the external genital organs in the male~     infant. Incomplete virilization of the genital bud results in hypoplasia of the tissues on~     the ventral aspect of the penis, with an ectopic ureteral meatus, a curved penile shaft and~     an incompletely formed foreskin. The condition is generally isolated and the aetiology is~     unknown. The pathogenesis is complex and involves hormonal, genetic and environmental factors~     (which are probably interlinked).~      A doubling in the incidence of hypospadias over the last 15 years has emphasized the probable~     role of environment factors: in fact, certain exogenous compounds (collectively referred to~     as endocrine disruptors (EDs)) may modify hormonal functions and thus exert harmful effects~     on the organism or its offspring.~      The male urethra develops between the 8th and 16th weeks of gestation in an~     androgen-dependence manner. In utero exposure of the foetus to EDs may have a~     physiopathological role in the abnormal development of the male genital bud and thus in the~     development of hypospadia. These EDs are present in many different substances, such as~     pesticides.~      Many epidemiological studies have evidenced an increase in the incidence of hypospadias in~     children born to exposed parents. Furthermore, animal studies have identified a certain~     number of compounds associated with hypospadias after in utero exposure. However, human~     foetal samples have very rarely been assayed in an attempt to measure the true level of~     impregnation (i.e. the dose received). At present, it is not possible to draw firm~     conclusions with regard to the true extent of a link between EDs and the increased incidence~     of hypospadia.~      The HypoMeco project is a prospective case-control study.~   "
58170|NCT02805478|"~     This is an observational study of cardiovascular risk factors and arterial or cardiac~     function in subjects with overweight or obesity. Subjects must be between 30 and 65 years of~     age, have a body mass index >27.0 kg/m2 and free from known heart disease and digestive or~     psychiatric disorders. Study aims include identifying sex-differences in traditional~     cardiovascular risk factors and structural and functional abnormalities in arteries and the~     heart in subjects with overweight or obesity, and how this is influenced by physical fitness.~   "
58171|NCT02805465|"~     This study is a multicenter, prospective, randomized cross-over study to compare His Bundle~     Pacing (HBP) with Bi-Ventricular Pacing (BiVP) in HF Patients with AF who need~     atrial-ventricular node ablation.~   "
58172|NCT02805452|"~     The purpose of this study is to determine whether Succinate of Solifenacin reduces the~     OverActive Bladder syndrome occurring during prostate irradiation.~   "
58173|NCT02805439|"~     The purpose of this study is to assess the efficacy and safety of S47445 versus placebo as~     adjunctive treatment of Major Depressive Disorder in patients with an inadequate response to~     antidepressant therapy.~   "
58174|NCT02805426|"~     This study is a randomized, double-blind, placebo controlled trial that will enroll 250 women~     (125 per study arm).~      The objective of the study is to determine the efficacy and tolerability of oral tranexamic~     acid when used as an adjunct to misoprostol for treatment of postpartum hemorrhage (PPH).~     Women will be diagnosed with postpartum hemorrhage if blood loss reaches 700ml in the~     calibrated receptacle. If diagnosed with postpartum hemorrhage , the woman will be randomized~     to receive either tranexamic acid or placebo, both in tablet form. All participants will~     receive 800 mcg sublingual misoprostol (4 tablets 200mcg each).~      The investigators hypothesize that tranexamic acid (in tablet form) as an adjunct to~     misoprostol will be more effective than misoprostol alone in stopping postpartum bleeding~     without recourse to further treatment in significantly more women.~   "
58192|NCT02805192|"~     Smart phones are omnipresent. Apps exist to calculate size of medical equipment and doses of~     medication if a valid weight or age is entered. During emergency situations, these values are~     often unknown. An App has been developed to measure the size of a child noninvasively. This~     App is now to be validated in clinical practice. App measured size is calculated and compared~     to the real size of a child. Via known percentiles of age/weight of the child is calculated~     upon the App measured size. This value is compared to the mother`s, physician`s and nurses~     estimation of the size and weight.~      Depending on the size multiple algorithms exist to estimate weight, age and medical values.~     (Kindersicher ®, Notfalllineal ® and Broselow Tape ®). These estimations by the~     calculations will also be compared to actual weight and age.~      Children from 0-12 years of age are included in the emergency Department of the Children`s~     Hospital of the University of Zurich after informed consent obtained by the parents. No~     therapy decisions from these calculations will be made. The therapy is independent of this~     study.~   "
58193|NCT02805179|"~     This is a study to determine the safety and effectiveness of high-dose radiation therapy (RT)~     with concurrent temozolomide in patients with newly diagnosed glioblastoma.~   "
58175|NCT02805413|"~     Main objective of the experiment is threefold: 1) to technically test a device for central~     blood pressure estimation for its applicability in a spaceflight-related environment and on~     the International Space Station. 2) Furthermore the objective is to compare central blood~     pressure estimates based on arterial pressure readings of different peripheral arteries. For~     central blood pressure estimation mathematical transfer functions as described by Karamanoglu~     and colleagues (11) will be used. 3) Finally the experiments' objective is to simultaneously~     apply phonocardiography together with ECG and carotid plethysmography to determine cardiac~     systolic time intervals in parabolic flight during gravity transitions.~      Secondary objective of the experiment is to simultaneously measure key variables of the~     central circulation during gravity transitions to expand the understanding of cardiovascular~     regulation in weightlessness. Furthermore spirometric measurements shall be performed during~     a parabolic flight day to observe changes in end-expiratory CO2. Arterial CO2 content is~     central for cardiovascular regulation.~      Our main hypothesis is that there is no difference between different methods of central~     arteria pressure determination.~      Concerning our secondary objective, this experiment is designed as an observational study.~     Thus no clear hypothesis was generated but the measured cardiovascular and respiratory~     variables will be analysed regarding differences correlated to gravity.~   "
58176|NCT02805400|"~     The main objective of this experiment is to evaluate the alterations in brain cortical~     activity induced by micro- and hypergravity conditions.~      A secondary objective is to correlate changes in brain cortical activity and brain~     oxygenation level with neurocognitive performance.~      Another secondary objective is to differentiate between the influences of hemodynamic and~     electro cortical changes and the influence of stress on cognitive performance alterations~   "
58177|NCT02805387|"~     Dystocic deliveries and the use of bicarbonate~   "
58178|NCT02805374|"~     The objective of this study is to evaluate the effect of food on the pharmacokinetics of a~     single oral dose of ASP1517 in non-elderly healthy adult male subjects.~   "
58179|NCT02805361|"~     REWARD is an Non Interventional study aims to describe the changes in the clinical outcomes~     of Type 2 Diabetes Mellitus patients who are treated with Dapagliflozin for a period of one~     year including the fasting period of Ramadan.~   "
58180|NCT02805348|"~     The objective of this study is to assess the long-term safety and efficacy of bixalomer under~     post-marketed setting.~   "
58181|NCT02805335|"~     PICC (Peripherally Inserted Central Catheter) are commun used. Just one paper report~     morbidity with suture as fixation system for PICC (dislodgement, infection) In the guidelines~     it's recommended to use sutureless device. The devices actually used are unsatisfactory~     because of the high risk of migration, accidental removal.~      A new device, called KTFIX PLUS, seem to be more secure for PICC fixation and offer the~     possibility to simplify the after care. This device may stay on patient for 4 weeks. Others~     devices may be changed 1/week.~      The investigators aimed to compare morbidity between this new device and the old one. The~     investigators also want to perform an economic evaluation of this device and compare patient~     quality of life.~   "
58182|NCT02805322|"~     Quantify the reliability and agreement of estimated core body temperature using the InstaTemp~     MD™ and other widely marketed reference Thermometers~   "
58183|NCT02805309|"~     Transcatheter aortic valve replacement (TAVR) is a minimally invasive procedure for older~     adults with severe symptomatic aortic stenosis who are considered high risk for surgical~     aortic valve replacement. Despite symptomatic and survival benefits, many patients experience~     functional decline after TAVR. This pilot study aims to test the feasibility of a home-based~     exercise intervention targeting endurance, strength, and balance as well as cognitive~     behavioral intervention to improve physical functioning and disability after TAVR.~   "
58184|NCT02805296|"~     Intensive phototherapy in form of double light is used worldwide in the treatment of severe~     neonatal hyperbilirubinemia. It has been debated if there is an upper limit on the efficiency~     of phototherapy. This study investigates whether double phototherapy reduces total serum~     bilirubin faster than single light during intensive phototherapy, using light emitting~     diodes, and whether there is an upper limit for the efficacy of phototherapy.~   "
58185|NCT02805283|"~     The purpose of this study is to evaluate the diabetes related treatment satisfaction for~     patients with type 2 diabetes mellitus.~   "
58186|NCT02805270|"~     The implementation of a medication reconciliation intervention including: medication~     reconciliation on admission and discharge, bedside medication counselling and take-home~     medication list, on the development of adverse drug events within 30 days post discharge as~     primary outcome. Secondary outcome is the evaluation of its impact on health care resource~     utilization~   "
58187|NCT02805257|"~     This study will determine the effectiveness of Mitomycin-C use in the glaucoma surgery Ahmed~     valve implantation. Approximately 100 patients will be enrolled, with half receiving the~     Mitomycin-C treatment and the other half receiving placebo treatment.~   "
58188|NCT02805244|"~     A mass balance study to determine the routes and rates of elimination of radioactivity, to~     determine total radioactivity in plasma and whole blood over time and compare levels to~     JTZ-951 and drug-derived entities in plasma and to determine pharmacokinetic (PK) parameters~     of JTZ-951 and its metabolite(s).~   "
58189|NCT02805231|"~     This study investigated whether vitamin D receptor gene polymorphism is altered in primary~     open-angle glaucoma subjects carrying the risk allele.Primary open-angle glaucoma patients~     and age-matched people in the Han population were enrolled. Vitamin D receptor polymorphic~     analysis was studied by polymerase chain reaction-restriction fragment length polymorphism~     technique.~   "
58190|NCT02805218|"~     The purpose of this study is to estimate the safety and efficacy of PEG-rhG-CSF in patients~     with lymphoma receiving chemotherapy.~   "
58191|NCT02805205|"~     The purpose of this study is to estimate the efficacy and safety of PEG-rhG-CSF in patients~     with breast cancer receiving chemotherapy.~   "
58194|NCT02805166|"~     The purpose of this study is to estimate the safety and efficacy of PEG-rhG-CSF in patients~     with lung cancer,head and neck cancer,colorectal cancer,and ovarian cancer receiving~     multi-cycle chemotherapy.~   "
58195|NCT02805153|"~     The purpose of this study is to evaluate the efficacy and safety of PEG-rhG-CSF in patients~     with breast cancer receiving chemotherapy~   "
58200|NCT02805088|"~     The initial aim of the project was to gain an understanding of the comprehension of~     language-oriented emotions among schizophrenic and bipolar patients. By language-oriented~     emotions, the investigators mean the emotions that are conveyed by means of language, whether~     through the emotional valence of the words, the expression of an emotional state or emotional~     prosody. Although they involve different diagnostic categories, schizophrenic and bipolar~     disorders nevertheless share a number of symptoms, in particular in the emotional sphere, and~     do so to such an extent that the question of whether there may, at the clinical, cognitive~     and etiopathogenic levels, exist a continuum between these disorders is frequently raised.~     Taking this hypothesis of a clinical continuum as our starting point, the investigators~     explored the understanding of emotions contextualized by language in these two clinical~     populations, namely patients exhibiting schizophrenic and bipolar disorders. To these~     populations, the investigators also added the dimension of vulnerability in the form of~     non-clinical participants varying in terms of their traits of schizotypy and hypomania, thus~     orienting this project toward the early identification of cognitive-emotional markers and~     possibly also their prevention.~   "
58201|NCT02805075|"~     This pilot phase I trial studies the side effects and best dose of fructooligosaccharides in~     treating patients with blood cancer who are undergoing donor stem cell transplant. Sometimes~     the transplanted cells from a donor can make an immune response against the body's normal~     cells (called graft-versus-host disease). Nutritional supplements such as~     fructooligosaccharides may reduce the incidence of graft-versus-host disease in patients with~     blood cancer undergoing donor stem cell transplant.~   "
58202|NCT02805062|"~     Malignant pleural effusion is a common clinical problem with median survival of approximately~     6 months thus efficient management of Malignant pleural effusion is important. In patients~     with a Trapped Lung, pleurodesis will be unsuccessful and an indwelling pleural catheter~     should be inserted instead. Accurate detection of Trapped Lung prior to insertion would avoid~     futile attempts at talc pleurodesis, re-intervention following failed pleurodesis and allow~     adequate time to plan for an indwelling pleural catheter insertion.Pleural manometry allows~     direct and objective measurement of intra-pleural pressure during pleural fluid~     aspiration.The primary aim of this study is to determine whether the addition of digital~     pleural manometry to clinical judgment, prior to and during local anaesthetic thoracoscopy,~     results in a clinically meaningful improvement in Trapped Lung detection.~   "
58203|NCT02805049|"~     The main objective of this study is to describe the pharmacokinetics of the prescribed~     echinocandins for septic shock with secondary peritonitis for which intra-abdominal fungal~     infection is suspected or proven.~   "
58204|NCT02805036|"~     Protective ventilation - combining a low tidal volume (between 6 and 8 ml/kg) and alveolar~     recruitment (AR) manoeuvres repeated every 30 minutes - is currently the standard of care for~     decreasing morbidity associated with mechanical ventilation.~      In contrast, there is no consensus on the type of recruitment manoeuvre, which varies from~     one centre to another and from one study to another.~      The investigators intend to compare two currently used AR techniques with regard to their~     ventilatory efficacy and hemodynamic safety:~        -  An end-tidal plateau at 30 cmH20 for 30 seconds.~        -  An end-tidal plateau at 10 cmH20 above the patient's plateau pressure for 30 seconds,~          without exceeding 30 cmH20.~   "
58205|NCT02805023|"~     Evaluate the feasibility of an autologous cell preparation composed of a mixture of cells~     enriched for endothelial progenitor cells (EnEPCs) and multipotent adult hematopoietic~     stem/progenitor cells (HSPC) (BGC101), in the treatment of patients suffering from peripheral~     arterial disease (PAD) with critical limb ischemia (CLI) who have not responded to optimal~     pharmacological treatment or control of risk factors and/or had a revascularization failure,~     and do not have the option of further revascularization treatment.~   "
58206|NCT02805010|"~     The objective of the study is to assess the single dose PK, safety, tolerability and~     immunogenicity of abatacept 125mg administered SC in Chinese healthy subjects.~   "
58207|NCT02804997|"~     The great majority of cardiac surgery patients develop a degree of post-operatory respiratory~     failure. This is due to several factors. The predominant element in the onset of this~     respiratory impairment is the constitution of foci of pulmonary atelectasis, caused by~     peroperative hypoventilation (in the presence or absence of ECC). The incidence has been~     evaluated at between 54% and 92%, depending on the study. The use of NIV (non-invasive~     ventilation) might (through the application of continuous positive expiratory pressure) help~     to counter the development of these atelectasic foci.~   "
58208|NCT02804984|"~     The project's objective is to identify and characterize somatic mutations in cases of~     idiopathic cytopenia of undetermined significance (ICUS) on the basis of molecular defects~     found in myelodysplastic syndrome (MDS), in order to validate the hypothesis whereby ICUS may~     be a precursor of MDS. To this end, high-throughput exon sequencing (using next-generation~     sequencing (NGS)) will be used to target the genes known to be mutated in MDS. This study is~     important for two reasons. Firstly, it will help to optimise the clinical monitoring of~     patients with molecular defects and considered to be at risk of progression. Secondly, it~     will provide a better understanding of the fundamental molecular mechanisms underlying the~     progression of ICUS to MDS.~   "
58218|NCT02804854|"~     Critically ill patients often succumb to acute respiratory disease (rapidly developing~     disease affecting the lungs). The lungs are the commonest organ to fail and require support~     in the intensive care environment. However, no accurate methods exist that can be used at the~     bedside to tell what is causing deterioration in a person's lungs. There are various examples~     of acute respiratory diseases that can occur as a result of numerous different causes, have a~     high risk of death and cannot be treated easily with drugs. When trying to accurately~     diagnose and classify these lung diseases there is a risk that the type of respiratory~     disease is misdiagnosed, missed or the level of severity is not captured. By using the field~     of optical molecular imaging and employing novel techniques and technologies, the~     investigators hope to demonstrate here that a bespoke chemical probe administered in micro~     doses (tiny doses) directly into the distal lung can rapidly and accurately detect activated~     neutrophils (cells of the immune system that are implicated in the development of these~     severe conditions), and so work towards a bedside test which could be used to diagnose,~     monitor and classify the disease in patients who are critically ill in the future. The~     population for this study are in intensive care where patients are normally intubated (have a~     breathing tube) due to the severity of their illness, this may be because of respiratory~     problems or respiratory problems can rapidly develop. Participants will have the chemical~     probe administered into their lungs and pictures taken through the tube already in place. As~     this probe lights up when it comes into contact with neutrophils the investigators will be~     able to tell if neutrophils are present. This will inform a larger study in which it's hoped~     that the method can be used to inform clinical decisions. The first procedure will take place~     within two days of initiation of mechanical ventilation and the direct contact with the study~     team will be completed within nine days.~   "
58209|NCT02804971|"~     Bronchiectasis have multiple etiologies but share a similar bronchial injury associated with~     inflammation, which leads to a progressive lung deterioration. This disease is responsible~     for a frequent access to care with an exacerbation rate of 1.8 per year with a high risk of~     hospitalization. Natural history is marked by recurrent infectious diseases which are the~     main prognosis factor. This disease is associated with an inflammation rate in the lung as~     well as in the blood. Up to now, no study has been described comorbidities associated with~     this chronic disease but our hypothesis is that cardiovascular diseases will be more frequent~     in these patients. In fact systemic inflammation driven by bronchial infections may increase~     frequency of cardiovascular diseases.~      The investigators decide to conduct a monocentric observational study to define the~     prevalence and characterization of cardiovascular comorbidities as well as markers of~     accelerated aging. We would like to test the hypothesis that cardiovascular comorbidities are~     frequent in bronchiectasis and may be associated with markers of inflammation and aging.~      Phenotype of the lung disease will include: spirometry, plethysmography, DLCO measurement~     according to the ATS/ERS guideline. 6M walking test and echocardiography will be also~     performed.~      Frequency of comorbidities will be calculated with data from questionnaire as well as~     standardized explorations.~      Aging related manifestations will be measured: arterial stiffness using aortic pulse wave~     velocity, bone mineral density using dual energy X-ray absorptiometry. Appendicular skeletal~     muscle mass and grip test were also performed.~      Blood test were also performed to measure inflammatory markers, cytokines and length of~     telomere in circulating leucocytes.~   "
58210|NCT02804958|"~     INcheon-Bucheon cohorT of patients undERgoing primary percutaneous coronary intervention for~     acute ST-ELevation myocardiaL infARction (INTERSTELLAR) registry is a retrospective,~     observational, 4-regional-hospital based registry reflecting current practices of management,~     risk factors, and clinical outcomes in patients with ST-segment elevation myocardial~     infarction undergoing primary percutaneous coronary intervention at cities of Incheon and~     Bucheon located in the mid-western part of the Korean peninsula between 2007 and 2014.~   "
58211|NCT02804945|"~     The goal of this clinical research study is to learn about the safety of giving mesenchymal~     stem cells (MSCs) to patients who have ARDS. Researchers also want to learn if these cells~     can help control ARDS when given with drugs that are routinely used to treat ARDS.~      In this study, participants will receive 1 infusion of MSCs.~      This is an investigational study. MSC infusions for the treatment of ARDS is investigational.~      Up to 20 patients will take part in this study. All will be enrolled at MD Anderson.~   "
58212|NCT02804932|"~     The purpose of this study is to use a randomized, double-blind, placebo controlled study~     design to comprehensively investigate the impact of 8-weeks of dietary nitrate~     supplementation on skeletal muscle blood flow, mitochondrial function, and exercise capacity~     in patients with type 2 diabetes (T2D).~   "
58213|NCT02804919|"~     Phase 1:The study is to evaluate the product reliability, therapy effectiveness and user~     feedback of a Continuous Positive Airway Pressure (CPAP) device in-home for up to 6 months.~      Phase 2: To evaluate the CPAP device with communication functionality with data upload.~   "
58214|NCT02804906|"~     This pilot feasibility study will test whether a home-based cardiac rehabilitation~     intervention, using physical therapist visits combined with mobile health technology, will~     prevent decline in high-risk patients post acute myocardial infarction (AMI). Participants~     will be randomized to either an intervention arm (home-based physical therapy), or a control~     (usual care) arm. Prior to discharge, participants in the intervention arm will receive a~     1-hour educational session by a research physical therapist that includes information on~     cardiac risk factor management, postoperative recovery, education on medication adherence,~     and a prescription for home exercise that is tailored to each patient's baseline abilities~     and limitations. Participants assigned to the control arm will receive a 30-minute counseling~     session on risk factor modification prior to discharge, in addition to usual care post-AMI.~   "
58215|NCT02804893|"~     This is a prospective, randomized, multicenter study on 300 patients (150 VATS lobectomies~     and 150 robotic lobectomies) affected by early stage (I-II) lung cancer. The expected~     recruitment is one year and two year follow up. Surgeons should have a minimum of 30 major~     lung resections performed using one of the two techniques for participation in the study.~     Each participating centers should have the possibility to offer both techniques (Robotics and~     Vats). The primary end point is a combination of conversion and complication rate. The~     presence of at least one of the two events is considered a failure. Considering the rate of~     failure of 35% in the VATS arm, we want to see a failure rate not over 20% in the robot arm,~     so with a power of 80% and an alpha error of 5%, we need a total of 300 patients.~   "
58216|NCT02804880|"~     The present study will examine (1) the effectiveness of personalised active referral to~     smoking cessation (SC) services and text messaging on encouraging SC services (2) explore the~     use of CBPR model to build capacity and to engage community partners in taking on this~     important public health issue for sustainability in the community. In addition, process~     evaluation will be conducted to assess the effectiveness of the recruitment activity and how~     it is linked with the overall program outcomes.~   "
58217|NCT02804867|"~     This study aims to identify signs of depression and bipolar disorder by measuring changes of~     certain molecules (biomarkers) that can be detected in dried blood spots. Our goal is to use~     these biomarkers to develop a diagnostic test to enable early treatment, which can lead to~     better patient outcomes.~   "
58241|NCT02804555|"~     In this study the investigators examine the effects of intraoperative oxygen administration~     to the mother on certain enzyme functions of the newborn. With this object blood samples are~     taken from the newborn's umbilical chord - which is otherwise a routine practice at the~     investigators clinic - and the mother's radial artery in parallel with umbilical clamping and~     cutting for blood gas and reactive oxygen species analyses. Samples are analyzed locally in a~     properly equipped laboratory.~   "
58242|NCT02804542|"~     The purpose of this study is to determine if non-continuous local anesthetic fascia iliaca~     blocks performed in the emergency department are effective for preoperative analgesia in hip~     fracture patients. Investigators hypothesize that patients with these blocks will have lower~     opioid requirements than patients in a historical group in whom blocks were not performed.~   "
67161|NCT02687854|"~     To obtain a better understanding on the comparative effectiveness of apixaban versus VKA~     (Vitamin K antagonist) for stroke prevention in patients with NVAF (Non-valvular atrial~     fibrillation) in a real-life setting.~   "
58219|NCT02804841|"~     Ireland is predicted to have the highest older adult population growth of any European Union~     country. A substantial economic and social challenge of this projected growth is the~     increased incidence of cognitive impairment and the likelihood of progression to dementia.~     Dementia's, such as Alzheimer's disease, typically have a long prodromal stage with brain~     changes identifiable from the earliest stages of neuropathology, providing an opportunity for~     intervention. Switching to a strategy of earlier identification and prevention would~     significantly reduce prevalence and the associated cost.~      The purpose of this pilot study is to evaluate the use of vitamin D supplements in community~     dwelling older adults as a lifestyle approach that may support cognitive and physical~     functioning. The research will incorporate several stages including an initial in-depth~     screening process, a novel and sensitive cognitive battery, 6 month double blind placebo~     controlled intervention of vitamin D3 (cholecalciferol) and a concluding participant feedback~     interview.~      These results will be used to assess the feasibility of recruiting and assessing community~     dwelling older adults for extensive nutrition related cognitive studies.~   "
58220|NCT02804828|"~     The purpose of this study is to develop preliminary evidence, such as effect size and~     variance estimates, to guide successful conduct of a properly-powered clinical trial to~     assess the benefit of a mitochondrial cocktail plus individualized correction of citric acid~     cycle (CAC) intermediates and amino acid (AA) abnormalities as part of a~     mitochondrial/oxidative stress treatment approach in Gulf War Illness (GWI).~   "
58221|NCT02804815|"~     Add-Aspirin aims to assess whether regular aspirin use after standard curative therapy can~     prevent recurrence and improve survival in individuals with non-metastatic common tumours.~     The question will be assessed in four different tumour types (breast, colorectal,~     gastro-oesophageal and prostate) by means of parallel cohorts within an overarching trial~     protocol.~      Eligible participants will be randomly assigned (double-blind) to either aspirin 100mg,~     aspirin 300mg or a matched placebo, to be taken daily for at least 5 years. Disease~     recurrence and survival will be assessed, along with adherence, toxicity, and other potential~     effects of aspirin (eg. cardiovascular).~      There is a large body of evidence indicating that aspirin has anti-cancer effects.~     Meta-analyses of cardiovascular trials of aspirin have shown short-term effects on cancer~     mortality and a decrease in risk of metastases, suggesting a role for aspirin in the~     treatment as well as prevention of cancer. Additionally, large observational studies of~     individuals taking aspirin after cancer treatment have shown improved disease-specific and~     overall mortality for specific tumour types.~      In the treatment setting, the risks of side effects associated with aspirin are expected to~     be outweighed by potential benefits. However, this has not yet been assessed in a randomised~     trial.~      As a low cost, generic and widely available drug, which is generally safe, if aspirin is~     shown to be effective, it could have a huge impact on cancer outcomes globally.~   "
58222|NCT02804802|"~     The main purpose of our project is to construct a lifestyle score based on a short~     questionnaire easy to complete and to validate it among participants in mass screening for~     colorectal cancer in Maine and Loire department over the next 2 years (2012 and 2013). We~     will evaluate the ability of our score to identify subjects with colorectal cancer diagnosed~     by the screening procedure (Hemoccult II ®, and colonoscopy if the test result is positive).~     Colorectal cancer will be the primary outcome for the assessment of the score's performance.~     The secondary endpoint will focus on colorectal adenomas diagnosed by the same procedure. Our~     secondary objectives are to test a second weighting system, evaluate the benefit in terms of~     predictive performance to add to the lifestyle score other dietary factors among that have a~     probable link with the risk of colorectal cancer, determine the acceptability of the~     questionnaire and to estimate by a cost-utility analysis the impact of applying a strategy of~     targeted screening using the developed score.~   "
58223|NCT02804789|"~     Brain changes associated with Alzheimer's disease may precede symptoms of Alzheimer's~     Dementia by over 20 years. The Investigators hope to be able to identify Alzheimer's disease~     at its very earliest stages when in theory treatments are most likely to be successful in~     preventing further spread of the disease in the brain and causing dementia. The aim of EPAD~     programme is to develop new treatments more quickly to prevent Alzheimer's dementia. A major~     component of the EPAD programme is the EPAD Longitudinal Cohort Study which can provide~     subjects for the EPAD trial as well as data to improve understanding of disease before~     dementia develops.~      The Investigators will approach a broad range of people over the age of 50 who have~     previously taken part in various research studies and consented to being recontacted for~     further research. Participants will be asked questions to assess their memory and other~     cognitive function. The participants will also undertake a brain scan, provide a sample of~     spinal fluid, blood, urine and saliva to look at markers in these bodily fluids that may~     change in Alzheimer's disease. The Investigators will then follow these participants until~     December 2019 repeating these tests annually. This will be called the EPAD Longitudinal~     Cohort Study (EPAD LCS). The main reasons for EPAD developing a cohort are to help the~     Investigators understand more about what happens to people before dementia develops, and to~     help recruit people more quickly into the EPAD trials of new medications or other~     interventions expected to prevent dementia.~      People in the EPAD LCS may be invited to take part in the EPAD Proof of Concept prevention~     studies to see if interventions can modify the probability of developing dementia or~     cognitive problems (this will be subject to separate ethics approval and consent). Together~     EPAD LCS and EPAD PoC make up the full EPAD Programme.~   "
58224|NCT02804776|"~     This is a pharmacodynamic study to evaluate the effect of gefitinib as induction therapy for~     patients who have resectable, Epidermal growth factor receptor (EGFR) sensitizing mutation~     lung cancer.~   "
58225|NCT02804763|"~     The purpose is to evaluate the efficacy and safety of three different doses of Dapirolizumab~     Pegol (DZP) versus placebo in adult subjects with moderately to severely active systemic~     Lupus Erythematosus receiving stable standard-of-care medications.~   "
58226|NCT02804750|"~     Cushing's syndrome is a relatively rare disorder caused by prolonged exposure to high levels~     of the glucocorticoid hormone cortisol. Cushing's syndrome may result from elevated~     endogenous or exogenous sources of cortisol. Endogenous Cushing's syndrome resulting from~     cortisol overproduction by the adrenal glands is the subject of this protocol.~      Patients with exogenous Cushing's syndrome, which develops as a side effect of chronic~     administration of high doses of glucocorticoids, are not eligible for enrollment in this~     study.~      The purpose of this study is to evaluate the safety and efficacy of CORT125134 for treatment~     of endogenous Cushing's syndrome. The multicenter study will be conducted in the United~     States and in Europe.~   "
58227|NCT02804737|"~     The purpose of this study is to evaluate the effectiveness of the GI clinic's currently used~     web-based instructions at St. Paul's Hospital.~   "
58244|NCT02804516|"~     Despite evidence to support early mobilization（EM）for critically ill patients,current status~     in Chinese ICUs is unknown.Understanding current practice patterns and challenges is~     essential to inform future research and strategies.~   "
58228|NCT02804724|"~     Human immunodeficiency virus (HIV) is a major global health concern which has resulted in an~     estimated 39 million deaths world-wide. Although it is now a treatable medical condition~     there is still avoidable morbidity and mortality associated with HIV infection in the UK.~     Late diagnosis (CD4 count of <350 cells/mm3 or AIDS-defining illness irrespective of CD4~     count) is associated with increased morbidity and mortality, increased risk of transmission,~     impaired response to antiretroviral therapy and increased healthcare costs. In Grampian, 49%~     of patients were diagnosed late between 1984 and 2011. Therefore, the aim of the study is to~     determine the factors associated with late HIV diagnosis in Grampian between 2009 and 2014 to~     ascertain whether diagnoses could have been made earlier.~      The study constitutes a secondary data analysis. Individuals newly diagnosed with HIV between~     January 2009 and December 2014 were identified from a Health Protection Scotland (HPS)~     database. The majority of outcome data were extracted from the existing HPS database. Missing~     data were collected via a retrospective review of patient case-notes, laboratory reports and~     an electronic patient management system. Patients were classified as early or late diagnosis~     and comparisons were made between the groups using statistical tests. The study sought to~     provide a basis for recommendations for improvement of information and services to facilitate~     earlier HIV diagnosis in Grampian.~   "
58229|NCT02804711|"~     Before this study, there will be an open-label, dose-escalation pilot study with a total of~     30 participants with 10 per dosage group. The aim of the pilot study is to explore the~     preliminary safety of an experimental recombinant staphylococcus aureus vaccine.~      This is a single center, double-blind, placebo control, dose-escalation phase 1 clinical~     trial. This study will determine the safety and side-effect profile, and immunogenicity of an~     experimental recombinant staphylococcus aureus vaccine. The study will be carried out~     following a dose-escalation method from the low dosage to the high dosage, i.e. the higher~     dosage vaccine could only be administrated after the first seven-day safety of the lower~     dosage vaccine is confirmed after safety observation.~   "
58230|NCT02804698|"~     This project will look to improve standards of care for diabetic patients by evaluating a~     program that supports participants in making healthy lifestyle changes.~      The program consists of 13 educational sessions that contain information about the prevention~     and care of diabetes and cardiovascular disease, physical activity, nutrition, community~     health and emotional well being.~   "
58231|NCT02804685|"~     This research presents a randomized clinical trial which evaluates the effectiveness of an~     exercise protocol on the knee-joint repositioning in futsal players related to a post-match~     muscle fatigue. Our hypothesis is the improvement of sensation in a knee in joint position~     before and after the match when performing our exercise program.~   "
58232|NCT02804672|"~     The purpose of this study is to examine the association between ideal cardiovascular health,~     diet and other lifestyles, biological risk factors, either well-established or emergent, and~     the risk of frailty in older adults, throughout different waves (2008-10, 2012 and 2015 -16).~   "
58233|NCT02804659|"~     Molecular analysis of the atheroma plaque. Screening for a novel biomarker of carotid status.~   "
58234|NCT02804646|"~     The purpose of this study is to discuss the efficacy and safety of recombinant human~     endostatin(endostar) durative intravenous transfusion combined with pemetrexed plus cisplatin~     or carboplatin in the first-line treatment of advanced lung adenocarcinoma with wild-type~     EGFR or ALK-negative,compared with chemotherapy without endostar.~   "
58235|NCT02804633|"~     The investigators hypothesis is that use of IV acetaminophen will significantly decrease use~     of post-operative opioid consumption and enhances recovery after colorectal surgery.~   "
58236|NCT02804620|"~     This study is a 12-month study. There are two different groups in the study. Both groups will~     enter the study after the graduation from 8-hour diabetes education course taught at VGH, St.~     Paul's, or Richmond Hospital. The first group will receive on-going support from their peers~     who have diabetes and are trained specifically to help other patients with diabetes. The~     second group will receive the usual care.~   "
58237|NCT02804607|"~     Traumatic skin lesions and in particular the burns which happen to growing children are~     complex and require an adapted and early patient care management. A child presents physical,~     psychological, and physiological characteristics which involve a specific functional~     prognosis. The aim of the study was to evaluate the functional outcome after a mid-term~     period from a severe skin traumatism occurring during childhood and which had required an~     initial graft.~   "
58238|NCT02804594|"~     This is a 4-week randomized, placebo-controlled, parallel group, double-blind, single center~     trial on effect of N-acetyl cysteine versus placebo on fatigue in patients with progressive~     MS defined by McDonald criteria. Subjects who enter the treatment phase of study, will be~     randomly assigned to either N-acetyl cysteine (1250 mg three times a day) or placebo (three~     times a day) for 4 weeks. There will be 3 in-person study visits (screening, baseline, and~     week 4) and 2 visits over the phone (week 2, and week 6 which is 2 weeks after completing~     last study drug dose). Visits will all occur in the morning to maximize consistency of~     assessments and evaluate main outcomes within 2 hours of morning dose of study medication.~     Fatigue questionnaires, and research samples will be obtained before neurological~     examination, or magnetic resonance imaging. Research blood draws will be obtained just after~     fatigue questionnaire completion. Brain spectroscopy will be obtained less than 2 hours after~     morning dose of study drug to maximize detection of the biological effect of study~     medication.~   "
58239|NCT02804581|"~     Gum Arabic (GA) rich dietary fiber it is a water-soluble dietary fiber derived from the dried~     gummy exudates of the stems and branches of Acacia senegal, GA found to have strong immuno~     modulator in vitro where it increased IL10 production showing strong anti-inflammatory~     effects (19).~      The aim of this study is to determine the role of gum Arabic in immunomodulation among~     patients with rheumatoid arthritis.~   "
58240|NCT02804568|"~     This study will determine the safety, tolerability, and pharmacokinetics (PK) of olanzapine~     and samidorphan in adults with schizophrenia following 14 consecutive days of oral~     administration of ALKS 3831.~   "
58245|NCT02804503|"~     Most studies on menu labels have been conducted in mostly non-Hispanic white individuals, and~     how menu labels affect calories and macronutrients ordered in Hispanics is not clearly~     understood. This study evaluated the impact of menu labels on calories and macronutrients~     ordered in Hispanics.~   "
67189|NCT02687490|"~     Abraxane in patients with visceral metastases dominant metastatic breast cancer~   "
58249|NCT02804451|"~     The aim of the study was to compare the intubation time and effectiveness, the grade of~     larynx visibility, and the ease of intubation in adults performed by nurses using 4 devices:~     a Macintosh blade laryngoscope (MAC), and a TruView EVO2 (EVO2), TruView EVO2 PCD (PCD), and~     ETView SL (ETView) laryngoscope, in simulated CPR settings with and without CC.~   "
58250|NCT02804438|"~     The purpose of this study is to collect a large amount of data that may assist in addressing~     the gap in knowledge of understanding pupillometer readings using a pupillometer device.~      The aim of this project is to establish normative values for pupillometer data. Measures of~     central tendency will be developed for the variables provided by automated pupillary exams,~     which will provide an enhanced understanding of clinically appropriate pupil values for size,~     reactivity, and neurological pupil index.~   "
58251|NCT02804425|"~     The use of simulation in medical education has been associated with positive results in the~     acquisition of knowledge, skills, behaviors and in patient outcome. According to Kolb et al,~     high-fidelity simulation provides concrete experience that is the basis for self-reflection,~     further experimentation and immersive learning named experiential learning. However the~     important number of learners and the extensive human resources required to deliver mannequin~     patient-based simulation limit its use for initial and repeated training. In general, 2-4~     trainees participate in each scenario while others may look at the progress of the scene~     through video transmission in a neighboring room while all trainees met thereafter for the~     debriefing. In typical learning sessions, all trainees act as a participant at least once.~     However, due to the increasing number of trainees, the investigators anticipate that some~     trainees might remain spectators during the whole simulation session.~      In our simulation unit (LabForSIMS- Faculté de Médecine Paris Sud), a simulation session for~     all third to forth year anesthesia residents (PGY3-4) of Ile de France has been established a~     few years ago. Each session includes a one-day training with 4 different immersive scenarios~     using a high fidelity mannequin. Each scenario is attended by 3 residents. In years before~     2014, the number of anesthesia residents to be trained was 35 and each of them could play the~     role of an actor at least once in the session (actor-spectator). In a previous preliminary~     study, the investigators found that the learning outcomes were similar for all residents at~     the end of the day, whatever the scenario in which they had played and those scenarios for~     which they had remained spectators. This led to the hypothesis that being an actor in a~     scenario might be less important than attending the whole session and participating in all~     debriefings. However, to our knowledge, few study has explored the outcomes of the learning~     process for spectators-only.~      The number of residents sharply increased to 110 from 2014 to 2016. Due to time constraints~     and limitation in the number of trained teachers, the investigators see that inevitably,~     several trainees will remain spectators during the whole session. The purpose of this study~     is thus to determine whether the status of the learner (actor-spectator vs spectator-only)~     during an immersive simulation has an impact of learning outcomes.~   "
58252|NCT02804412|"~     Constraint-induced aphasia therapy (CIAT) has proven effective in stroke patients. It has~     remained unclear, however, whether intensity of therapy or constraint is the relevant factor.~     This study will give an answer to this question to improve speech and language therapy.~   "
58253|NCT02804399|"~     The purpose of this study is to estimate the effect of rifampin on the single dose PK of~     PF-06463922.~   "
58254|NCT02804386|"~     Title Efficacy and Safety of Zoval (Sofosbuvir) and Ribavirin with or without Interferon~     among Pakistani Population: A real life trial Hepatitis Eradication Accuracy Trial of~     Sofosbuvir (HEATS) Study Design Endpoint Classification: Safety/Efficacy Study Intervention~     Model: Treatment agents (non-interventional observational study): Real life clinical practice~     study Masking: Open Label Primary Purpose: Treatment Duration Around 12 Months Study Centre~     Multi centric Study~   "
58255|NCT02804373|"~     The investigator thinks that the oxytocin (OT) can improve durably and significantly the~     behavior disorders and thus the socialization but also the satisfaction and could thus be an~     interesting therapeutic alternative for the patients presenting a Prader-Willi Syndrome~     (SPW). Although today several studies demonstrated the effects of the OT in various domains~     of the behavior, the investigator do not know either its specificity of action about the~     cerebral level, or its duration of action, or the optimal modalities of administration and in~     particular at patients SPW.~   "
58256|NCT02804360|"~     Purpose: Cystoid macular edema (CME) in retinitis pigmentosa (RP) has been managed in several~     ways with little success. The aim of our study was to report the use of intravitreal~     dexamethasone implant in a large series of patients with RP and CME.~      Setting: Retrospective case series. Methods: Cases were diagnosed as RP based on the classic~     fundus triad of bone-spicule pigment deposits (intraretinal pigmentary migration), retinal~     vessel attenuation, waxy pallor of the optic disc along with night blindness and attenuated~     ERG amplitudes (delays in rod or cone b-wave implicit times). Family history of RP and family~     screening for RP were important in establishing the diagnosis in eyes with some diagnostic~     challenge. CME was diagnosed by intravitreous fluorescein angiography IVFA and spectral~     domain optical coherence tomography (SD-OCT). BCVA was monitored using Snellen visual acuity~     chart and CME was monitored by SD-OCT on follow-up visits.~   "
58257|NCT02804347|"~     The sense of smell and cognition are known to be closely associated with mood and emotional~     processes. However, despite the clear links between olfaction and cognitive processes with~     emotional states, research into the role of olfaction, cognition, and mood disorders has so~     far yielded variable results. This study proposes to investigate the ability to detect and~     identify odours and assess cognition in a group of patients with unipolar and bipolar~     depression prior to and after receiving their scheduled electroconvulsive therapy (ECT) or~     intermittent theta burst stimulation (iTBS) treatments. Olfaction will be evaluated utilizing~     standard olfactory testing protocols using commercially available kits. Cognition will be~     evaluated utilizing standard cognitive test protocols in a functional magnetic resonance~     imaging protocol. The results will potentially shed light on the link between olfaction,~     cognition and mood disorders.~   "
58258|NCT02804334|"~     The goal of this project is to study ~45 molecules in blood cells that may differentiate~     patients with bipolar disorder from healthy controls.~   "
58267|NCT02804217|"~     Patients with advanced non-small-cell lung cancer (NSCLC) harboring sensitive epithelial~     growth factor receptor (EGFR) mutations invariably develop acquired resistance to EGFR~     tyrosine kinase inhibitors (TKIs). Identification of actionable genetic mutations can be~     helpful for guiding the subsequent treatment. This study aimed to analyze the genetic profile~     of NSCLC harboring acquired resistance to the first-generation EGFR TKIs using next~     generation sequencing (NGS).~   "
58268|NCT02804204|"~     Multicenter, prospective, observational study for evaluating if circulant rheumatoid factor,~     cyclic citrullinated anti-peptide anti-bodies and albumin can be used as potential predictors~     in the response to the treatment with anti-TNF in patients with rheumatoid arthritis after 24~     weeks of treatment.~   "
58269|NCT02804191|"~     A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to~     Evaluate the Efficacy and Safety of LO2A Eye Drops in Patients with Moderate to Severe~     Conjunctivochalasis~   "
58259|NCT02804321|"~     Atrial fibrillation (AF) is the most common cardiac arrhythmias with a constantly growing~     prevalence. Two main techniques are used today to restore sinus rhythm: electrical~     cardioversion and radiofrequency ablation.~      Radiofrequency ablation has become a recognized and effective treatment of AF. Despite a~     relatively high success rate (about 80%), a substantial number of patients require a second~     procedure to obtain sinus rhythm. Many publications have led to the study of predictors of~     failure of this ablation factors (BMI, uncontrolled hypertension, size of the OG...) but to~     date no parameter is reliable and usable in daily practice.~      It is the same for electrical cardioversion. Despite a relatively high immediate success rate~     of approximately 80%, a significant number of patient relapse arrhythmia in short and long~     term. Many publications have led to the study of predictive factors of failure (seniority and~     type of AF, uncontrolled hypertension, size of the OG, mitral valve disease...) but so far~     the results are disappointing.~      In AF patients with heart disease underlying, it has been well demonstrated that the~     renin-angiotensin system (RAAS) was strongly activated. In addition, it is now well~     established that elevated plasma aldosterone as in primary hyperaldosteronism is associated~     with a significantly increased risk of occurrence of cardiovascular events. The high plasma~     concentrations were also highlighted in the acute phase of myocardial infarction, or heart~     failure and are associated with an increase in major cardiovascular event rate, especially~     arrhythmias. In some experimental models of heart failure, it has been demonstrated a~     suppression of the occurrence of spontaneous FA by an anti-aldosterone treatment. The~     arrhythmogenic effect of aldosterone has also been shown in animal models. All these results~     indicate a potential role of aldosterone in the genesis of an arrhythmogenic substrate and~     the FA.~      The hypothesis of this study is that aldosterone plasma levels in pre-reduced patients is~     predictive of recurrence risk of atrial fibrillation or other supraventricular tachycardias~     (flutter or atrial tachycardia) after FA reduction, either in using a radiofrequency ablation~     or via electrical cardioversion.~   "
58260|NCT02804308|"~     Breast cancer is a multifactorial disease affecting women, and one of the treatments for its~     healing and survival is hormone therapy. Aromatase inhibitors are third-generation drugs that~     promote lower chance of metastasis, but their side effects include the loss of bone mineral~     density and increased fat percentage. In this way, the Combined Training (combined resistance~     and endurance training) may be an interesting strategy to minimize the side effects of~     aromatase inhibitors, providing better quality of life, survival and changes in body~     composition.~   "
58261|NCT02804295|"~     Injured trauma patients in the Emergency Department (ED) may be a particularly important~     group to target for screening and intervention for prescription drug misuse (PDM). These~     patients have high rates of psychiatric and substance use co-morbidity and pain management~     for their injuries (e.g. broken bones, burns) will often require prescribed opioid pain~     medications and other controlled substances. To date, there are no effective ED-based~     interventions for PDM. Collaborative Care is a longitudinal model of care that combines~     multiple elements for patients with complex medical comorbidities. This model holds promise~     as an intervention strategy for injured patients in the ED that are at risk for prescription~     drug misuses. Collaborative Care from the ED is innovative and requires developing follow up~     procedures on a population that has previously been difficult to follow and may have~     previously avoided consistent health care delivery. The primary objective of this study was~     to determine the feasibility of initiating a collaborative care intervention for injured ED~     patients with PDM by enrolling patients into an open trial of this intervention. A secondary~     objective was to determine if PDM decreases over time after enrollment and developing~     successful follow-up procedures to deliver longitudinal care.~   "
58262|NCT02804282|"~     The proposed single-dose study aims to evaluate the product design clinical performance of~     the to-be-marketed drug-device combination product, the sc2Wear Furosemide Combination~     Product, in adult Subjects previously diagnosed with mild to advanced heart failure.~      The study drug formulation is a buffered Furosemide Injection Solution, 8 mg/mL, (total dose~     equals 80 mg/mL) administered subcutaneously for a total of 5 hours. The study device is the~     sc2Wear Furosemide Pump adhered to the body using medical grade adhesive.~      The objectives of this study are:~        -  To demonstrate that the to-be-marketed drug-device combination product performs as~          intended and delivers 80 mg of Furosemide subcutaneously in the abdominal area~        -  To assess safety and local tolerance of the drug-device combination product~   "
58263|NCT02804269|"~     Biobank is a program which collects biological samples, health information and imaging data~     from consented patients and stored them at the core facility. These information would be used~     to study the molecular, imaging and outcome studies of cardiovascular health and disease.~   "
58264|NCT02804256|"~     The National Heart Centre Singapore has recently created a biorepository that is IRB approved~     for the use in genetic studies: molecular and imaging studies of cardiovascular health and~     disease (CIRB Ref: 2013/605/C). This repository enables IRB approved projects within the~     National Heart Centre Singapore to access the samples for use in biomarker or genetic studies~     with consent from patients for these studies. The IRB approved biorepository process also~     allows for patients, when they have consented to this, to be approached for inclusion in~     additional studies at National Heart Centre Singapore.~      In this study, the investigators will examine the genetic variation in genes known to cause~     inherited cardiac conditions and also look for circulating biomarkers (ICC) in 600 patients~     with ICC and in 500 patients with ischemic heart disease (e.g.IHD) who will be used as~     controls. Healthy controls will also be used (800) as they become available in the~     biorepository. All samples have already been collected in the NHCS biorepository.~      These patients would have been recruited and consented to the biorepository. This will enable~     all to better understand heart disease in Singaporean patients. In addition, the~     investigators will invite a subset of 10 patients with ICCs to provide a second blood sample~     (20mls - 2 tablespoons) on top of the samples that will be collected for the biorepository.~     The second blood sample will be used for antibody biomarkers that will be developed in the~     basic science laboratories. These antibodies will be used to develop new biomarkers of human~     heart disease to improve human health.~   "
58265|NCT02804243|"~     The purpose of this study is to compare the exercise endurance between oxygen therapy with~     rehabilitation and nasal high flow therapy with rehabilitation for the patients with chronic~     respiratory failure receiving long-term oxygen therapy.~   "
58266|NCT02804230|"~     The purpose of this study is to evaluate the feasibility, safety, and initial effectiveness~     of ExAblate thermal ablation of a subcortical focal epileptic target area in the brain of~     patients suffering from medication-refractory epilepsy, using the ExAblate transcranial~     system to produce multiple sonications targeted in the lesion of interest. The investigators~     will establish the feasibility and collect data to establish the basic safety of this type of~     treatment as the basis for later studies that will evaluate its full clinical efficacy.~   "
58478|NCT02801474|"~     Patients with a posterior malleolar fracture were recruited and assigned to the direct~     reduction (DR) group or the indirect reduction (IR) group. Following reduction and fixation~     of the fracture, the quality of fracture reduction was evaluated in radiograph and CT images.~     Functional outcome was evaluated at the last follow-up.~   "
58270|NCT02804178|"~     This is a Phase 2 multicenter, single-blind, multiple dose study to evaluate the safety and~     efficacy of orally administered ATR-101 in subjects with classic congenital adrenal~     hyperplasia (CAH). Treatment duration will range from a minimum of approximately 2 months to~     6 months per subject. A subject may receive a minimum of one dose level or up to a maximum of~     5 dose levels, in sequentially increasing dose strengths. Each dose level will last 28 days.~   "
58271|NCT02804165|"~     Type 1 diabetes (T1D) is the most common endocrine disorder in children. In France, T1D~     prevalence is estimated to 12.2 per 100 000. Worldwide T1D incidence increased rapidly in the~     last decades, around 3% per year. T1D is caused by autoimmune destruction of pancreatic beta~     cells, leading to hyperglycaemia. T1D was recently associated an important loss in life~     expectancy compared with the general population. To date, the precise aetiology of T1D onset~     and the mechanisms involved in T1D remain unknown and no preventive treatment of T1D exists.~      It is now well admitted that T1D results from a combined effect of genes, environmental~     factors and gene-environment interactions. Several genetic factors have been reported as~     associated to T1D, the most important being the human leukocyte antigen class II genes. Whole~     genome association studies suggested more than 50 T1D other susceptibility locus, but~     conferring individually a modest risk to develop T1D. Longitudinal studies demonstrated that~     only a low fraction of genetically predisposed subjects develop T1D and all these genetic~     factors cannot explain the increase in prevalence of T1D in the latter half of the 20th~     century, suggesting the implication of environmental factors.~      Literature has accumulated a lot of evidence for the role of enterovirus in T1D. Several~     retrospective, prospective, post-mortem human studies, as well as animal studies, strongly~     suggest contribution of human enteroviruses to the pathogenesis of T1D. Enterovirus probably~     play a dual role in T1D, some enterovirus being associated with an increased risk of T1D and~     others with a protective effect. Interestingly, several T1D susceptibility loci are~     implicated in antiviral response. Epidemiologic and genetic approaches have led to new~     insights into T1D causation, but a collective explanation is still lacking.~      The project aims at (1) demonstrating the gene-enterovirus interaction effect on T1D onset~     and (2) characterizing the precipitating effect of enterovirus on T1D by a follow-up study~     of T1D high-risk subjects (first degree unaffected relatives with positive autoantibodies to~     islet antigens).~      A structural originality of this project is to perform a family-based study of~     gene-enterovirus interaction in T1D using innovative and robust methods. This project will be~     conducted in close collaboration between our INSERM unit, the Inter-regional network of~     paediatric diabetology, labelled biobanks (CBC Biotec of Hospices Civils de Lyon and CRB-LRB~     of Lariboisière' hospital at Paris), the Centre National de Référence des Enterovirus at Lyon~     and the Centre National de Génotypage at Evry.~      The investigators will first conduct a 3-years pilot study (2016-2019), based on a sample of~     250 nuclear families ascertained through a paediatric T1D proband in four centres. Families~     will be ascertained during the hospitalization of the proband at the time of T1D diagnosis.~     The study will be then extended to whole Inter-regional network of paediatric diabetology.~      This research is a unique opportunity to explore further the implication of enterovirus and~     their interactions with genetic factors involved in T1D susceptibility and aims to target~     high-risk T1D subjects. This innovative project opens the door of the development of~     preventive therapy for T1D.~   "
58272|NCT02804152|"~     Pregnant women using prescription opioid medication (pain medications) are invited to take~     part in a program for the reduction of pain and prescription opioid misuse.~   "
58273|NCT02804139|"~     The purpose of this study is to determine whether a physical therapy program which includes~     scar management, core retraining, and lumbar and pelvic joint mobilization will significantly~     impact the postpartum recovery following Cesarean section during the immediate postpartum~     period and during the first 1.5 years following childbirth.~      All patients who enroll in the study will receive standard treatment following a C-section~     delivery. Subjects will be randomized into one of two groups; one group will receive physical~     therapy in addition to standard post C-section treatment, and the other group will receive~     standard post C-section treatment with no additional physical therapy. Both groups will~     complete questionnaires regarding their pain and recovery from C-section delivery to~     determine if there is a difference in recovery between the group receiving physical therapy~     and the group not receiving physical therapy.~   "
58274|NCT02804126|"~     Comparison of two types of analgesia after cesarean section.~      All patients will anaesthetised with spinal technique. Ultrasound-guided transversus~     abdominis plane or quadratus lumborum block to treat postoperative pain. Postoperative pain~     will measured with visual-analogue scale (VAS). 1, 2, 6 months after surgery each patient~     will be called to assess neuropathic pain with Neuropathic Pain Symptom Inventory (NPSI).~   "
58275|NCT02804113|"~     The VMI-CFA study investigates the efficacy of the Supera Stent in the treatment of common~     femoral artery stenosis or occlusion. 100 patients will be included with a RF of 2 to 4. The~     lesion is located within the native CFA and treated with predillation prior to stenting with~     the Supera Peripheral Stent System. Patients will be invited for a follow-up visit at 1, 6~     and 12 month post procedure. The primary endpoint of the study is the primary patency at 12~     months and periprocedural events up to 30 days post procedure. Secondary endpoints include~     technical success, primary patency rate at 1 & 6 month, freedom from TLR at 1-, 6- and 12~     month follow-up and clinical success at 1-, 6- & 12-month follow-up.~   "
58276|NCT02804100|"~     A multi-centre observational, non-interventional study is to dynamically monitor the changes~     of circulating tumor DNA (ctDNA) in late stage NSCLC patients under Gefitinib treatment.~   "
58277|NCT02804087|"~     To evaluate the safety and performance of the MobiusHD system in subjects with resistant~     hypertension.~   "
58278|NCT02804074|"~     MASTER study is a 4-year prospective, randomized, open-label, blinded-endpoint study (PROBE)~     comparing 2 management strategies 1) office BP as a guide to treatment, or 2) 24-hour ABP as~     a guide to treatment. Study objectives are to investigate whether a management strategy based~     on out-of-office BP (Ambulatory BP monitoring) versus a management strategy based on office~     BP measurements is associated with differences in outcome, including cardiovascular and renal~     intermediate end points at one year; cardiovascular events at 4 years and changes in a number~     of blood pressure-related variables throughout the study. Patients will be followed-up during~     the first year focusing on changes in left ventricular mass index (LVMI, co-primary endpoint)~     and Urinary albumin excretion (UAE, albumin/creatinine ratio, co-primary end-point), and~     during the whole 48 month period for both changes in LVMI and UAE and events including~     all-cause mortality, CV morbidity and mortality, cerebral morbidity and mortality.A total of~     1240 subjects will be recruited by 30 centers, taking into account a dropout rate of 15% (620~     subjects per randomization arm).~   "
58279|NCT02804061|"~     Nutrition and exercise behaviour change programs can prevent excessive gestational weight~     gain (EGWG). The Nutrition and Exercise Lifestyle Intervention Program (NELIP) is a~     previously published two-behaviour change program which was successful in preventing EGWG~     across normal weight, overweight and obese pre-pregnancy body mass index (BMI) categories~     (Ruchat et al. 2012; Mottola et al. 2010), however some women found it difficult to adhere to~     two lifestyle behaviour changes throughout pregnancy. The proposed pilot randomized~     controlled trial will address the issue of adherence by identifying the best way to offer a~     two-behaviour change program (NELIP) to pregnant women to increase the effectiveness of~     preventing early and total EGWG. Participants will begin the program at <18 weeks gestation~     and will be randomized to one of three groups: A) Receive both behaviour changes (Nutrition~     AND Exercise) simultaneously at entrance to the study; B) Receive the nutrition component~     first followed sequentially by the introduction of exercise at 25 weeks gestation (Nutrition~     FOLLOWED by Exercise); C) Receive the exercise component first followed sequentially by the~     introduction of the nutrition component at 25 weeks gestation (Exercise FOLLOWED by~     Nutrition).~   "
58280|NCT02804048|"~     Aim: To evaluate the effectiveness of physical therapy intervention techniques in the~     improvement of dyspareunia in climacteric women.~      Study design: This is a randomized controlled trial.~   "
58281|NCT02804035|"~     The proposed pilot study aims to gain experience with the first clinical use of the to-be~     marketed drug-device combination product, the sc2Wear Furosemide Combination Product and to~     assess methods and procedures for evaluation of product performance.~      The objectives of this study are:~        -  To gain first in man experience of a novel drug-device combination product~        -  To evaluate the suitability of the methods and procedures for evaluating of the~          performance of the sc2Wear Pump~   "
58282|NCT02804022|"~     This is a closed-loop system which is embodied in a novel and intelligent algorithm that~     takes into account patients' vital signs. The system allows better and responsive titration~     of personalized pain relief together with non-invasive physiological monitoring that measures~     oxygenation, breathing and heart rate continuously.~   "
58283|NCT02804009|"~     Anxiety will be assessed from two aspects, the somatic and emotional. ANGST aims to determine~     how anxiety correlates with psychological parameters (personality traits, coping strategies~     and depressive symptoms) and with the outcome of elective coronary angiography (CA).~   "
58284|NCT02803996|"~     This is a single-site, randomized, double-blind, double dummy, placebo-controlled single and~     multiple doses study of Aramchol in healthy Chinese volunteers. The subject population that~     was enrolled for Aramchol 004 was not specifically designed to understand the PK profile of~     Aramchol in subjects of Chinese descent. Therefore, this study (Aramchol 015) has been~     undertaken to ascertain the PK profile of Aramchol following single and multiple doses in a~     Chinese population under fed conditions utilizing the light breakfast from Aramchol 004.~      This study will consist of two parts and the subjects will be assigned to two parts.~      In each part of the study, subjects will be enrolled in the study within 28 days of~     screening.~   "
58285|NCT02803983|"~     The purpose of this study is to compare the early postoperative radiologic and clinical~     outcomes of pediatric hip plate and cannulated screw fixation in pediatric femoral neck~     fracture (Delbet type II and Delbet type III).~   "
58286|NCT02803970|"~     The aim of this study is to collect data on Korean patients with borderline ovarian tumors.~   "
58287|NCT02803957|"~     The objective of this trial is to assess the safety and effectiveness of the study device in~     subjects with degenerative mitral valve disease receiving a mitral valve repair without~     cardiopulmonary bypass (treatment group) when compared to subjects receiving mitral valve~     repair using standard surgical techniques with cardiopulmonary bypass (control group).~   "
58288|NCT02803944|"~     Azithromycin is an antibiotic currently prescribed continuously in cystic fibrosis patients.~     It was shown that this treatment taken every day or every week for 12 months, can improve the~     respiratory state of patients. From the second year of treatment, it would appear there is~     more profit to continue such treatment.~      The main objective is to study the association between continuous use of azithromycin and~     lung function measured by Forced expiratory volume in one second (FEV1), after two years of~     treatment.~   "
58289|NCT02803931|"~     This study aims to test the hypothesis that cardiogoniometry (CGM) is helpful to identify the~     site of the culprit vessel in patients with NSTEMI in comparison to 12-lead ECG.~      NSTEMI constitutes a clinical syndrome subset of acute coronary syndrome which is most~     usually caused by atherosclerotic coronary artery disease. It is defined by~     electrocardiographic (ECG) ST-segment depression or prominent T-wave inversion and/or~     positive biomarkers of necrosis (e.g., troponin) in the absence of ST-segment elevation and~     in an appropriate clinical setting (chest discomfort or angina equivalent). The standard 12~     lead ECG is not commonly sensitive at localising the site of the culprit lesion and even~     coronary angiography may not always be helpful as the majority of lesions will not have~     angiographically evident thrombus. Patients with an ACS may have multivessel disease and it~     is often not possible to identify the precise site of the culprit lesion. In patients with~     multivessel disease, interventionists will frequently target the most severe stenosis even~     though this is not necessarily the acute lesion.~      CGM (Cardiogoniometry cardiologic explorer, Enverdis GmbH medical solutions, Germany) is a~     form of 3D vector electrocardiography which can provide quantitative analysis of myocardial~     depolarisation and repolarisation. It has CE mark and has been shown to be more sensitive and~     specific than standard 12-lead ECG at diagnosing stable coronary artery disease. Furthermore,~     recent work has shown CGM to be more sensitive at detecting patients with NSTEMI than~     conventional 12-lead ECG~      In summary, there is evidence that CGM is more efficacious than 12-lead ECG at the diagnosis~     of both stable CAD and ACS. The hope is this that the clinical application can be extended to~     localising ischaemia in the culprit vessel and be a valuable diagnostic aid.~      The primary objective of this study is to investigate the efficacy of CGM to identify the~     culprit vessel in patients presenting with NSTEMI. Secondary endpoint will be to evaluate the~     efficacy of CGM to detect a significant coronary stenosis (defined as ≥70%) as compared to a~     standard 12-lead ECG~   "
58290|NCT02803918|"~     Primary Objective:~      To demonstrate safety of 14-day repeated lixisenatide doses with 3 ascending doses as~     compared to placebo in pediatric patients with T2DM.~      Secondary Objectives:~        -  To evaluate plasma concentrations of lixisenatide after repeated doses (3 ascending~          doses) and pharmacokinetic parameters of repeated lixisenatide doses in pediatric~          patients with T2DM.~        -  To evaluate the change from baseline in fasting and post-prandial plasma glucose~          concentrations during a standardized meal test after 3 ascending repeated doses of~          lixisenatide in comparison to placebo.~   "
58291|NCT02803905|"~     The study is a phase 2, monocentric, open-label study. The investigators will recruit 12~     patients with T1D to be randomly (1:1) assigned to receive islet either into the liver~     through the portal venous circulation (standard procedure; arm A, n=6) or directly into the~     omentum (arm B, n=6). Patients will be selected from those eligible for islet Tx based on~     local practice and guidelines. Immunosuppression will consist of five doses IV infusion of~     rabbit Anti-thymocyte Globulin (ATG, Thymoglobulin®), starting two days prior to the islet~     transplant. Maintenance mycophenolate mofetil (MMF) therapy (1-2 g/day as BID dosing) will be~     started on Day -1 pre-transplant. Tacrolimus will be administered orally twice daily on Day 1~     post-transplant to maintain a trough level of 10-12 ng/mL for 3 months, then 6-10 ng/mL~     thereafter. Etanercept will be given IV before the islet transplant (50 mg), and then at 25~     mg (subcutaneously) on POD +3, +7 and +10.~   "
58292|NCT02803892|"~     This study is a phase 2, single-center, prospective, randomized, double-blind,~     placebo-controlled, 3-arm parallel group (1:1:1) intervention trial to determine the efficacy~     of 4 weeks rapamycin treatment and 4 weeks rapamycin treatment plus 3 months vildagliptin~     treatment versus placebo in increasing endogenous insulin production and correcting glycemic~     lability. It will involve 60 patients with long standing type 1 diabetes (T1D). Patients will~     receive for one month placebo (Group 1), rapamycin plus placebo (Group 2), or rapamycin plus~     Vildagliptin (Group 3). Rapamycin will be administered at an initial dose 0.2 mg/kg orally on~     day 0 followed by 0.1 mg/kg/die (target trough levels: 8-10 ng/ml). Vildagliptin will be~     administered at a dose of 50 mg x2/die starting from day 0. After 4 weeks of treatment~     (period A), patients will discontinue rapamycin or relevant placebo treatment, but continue~     Vildagliptin or placebo for a further 8 weeks and be monitored over this period (period B).~   "
58309|NCT02803671|"~     This project corresponds to the main field of research of the investigators's laboratory~     concerning analysis of cerebral electrometabolic and haemodynamic activity in neonates. In~     this context, the investigators have developed know-how and specific acquisition and analysis~     tools (2 patents and several publications), allowing them to apply this know-how in children~     with patent ductus arteriosus.~      Patent ductus arteriosus after birth is characterized by shunting of a variable proportion of~     cardiac output towards the pulmonary circulation. The direct consequences of this shunting~     are: (i) overload of the pulmonary vasculature and left heart chambers, increasing the risk~     of left heart failure, haemorrhagic pulmonary oedema and late respiratory complications such~     as bronchopulmonary dysplasia; (ii) in contrast with the pulmonary circulation, other~     systemic organs are deprived of part of their normal perfusion and are subject to ischaemic~     hypoxia; the resulting neuronal hypoxia rapidly leads to metabolic and electrical~     dysfunction, the analysis of which constitutes one of the objectives of this project.~   "
58293|NCT02803879|"~     Some patients with heart failure require treatment called cardiac-resynchronisation therapy~     (CRT) which involves putting a pacemaker into your heart to make both ventricles (the lower~     chambers of your heart) contract together, making the pumping of the blood to the rest of~     your body more efficient.~      it is important to get the CRT pacemaker checked to make sure that it is working correctly~     and performing its job. However it can be difficult to adjust the settings of the pacemaker~     just the right amount to ensure the heart is pumping efficiently.~      One of the ways this can be done is by using a special machine which uses ultrasound to make~     a 2-dimensional image of the heart called echocardiogram. This technique can also be used to~     measure the flow of blood in your heart and calculate how efficient it is at pumping blood.~     However adjusting the settings of the pacemaker with this device is difficult to use and time~     consuming.~      Electrocardiogram (ECG) a 2-dimensional electrical tracing of the hearts activity is another~     tool used to help adjust the settings of pacemakers, to make the heart pump more efficiently.~     Furthermore, recent research has shown that this is better than echocardiogram at optimising~     pacemaker device settings.~      A new type of ECG called cardiogoniometry (CGM) has recently been developed which creates a~     3-dimensional view of the hearts electrical activity and has already been shown to be better~     than normal ECG at diagnosing certain conditions like angina and heart attacks. However it~     has never been used to try optimise the settings of the pacemakers used in CRT and we hope it~     will be a quicker and easier to use than then other methods available. More importantly we~     hope by doing this it will reduce the symptoms that patients suffer as it is making the heart~     pump more efficiently.~      As it has been untested and never used in this setting before, we need to know first if the~     CGM machine will recognise when the settings on the pacemaker are changed.~      The aims of this study is to see if the CGM machine can pick up changes to pacemaker~     settings, with the hope of running a later study to see if it can be used to optimise~     settings on the pacemaker used in CRT.~   "
58294|NCT02803866|"~     In a hospital environment, initial parenting of a family with a preterm neonate will be very~     different than expected. This unusual and stressful situation may determine the~     self-confidence perceived by mothers and fathers in caring their baby and therefore could~     shape future interaction with him/her as well as neurodevelopmental and behavioral~     development of preterm infants.~      24/7 neonatal units allow parents stay with their baby whenever they want but this free~     access nor guarantee neither encourage parenting self-efficacy if it isn`t hand in hand with~     a specific training program for parents.~   "
58295|NCT02803853|"~     The overall objective of the study is to reduce adult obesity in participating American~     Indian (AI) communities and to improve understanding of the behavioral and environmental~     factors affecting obesity in these settings.~   "
58296|NCT02803840|"~     Patients with Diffuse Large B-cell Lymphoma with indication for palliative radiotherapy are~     treated with low-dose radiation (2 x 2 Gy) to the symptomatic sites only. The primary~     endpoint of the study is the response rate and Quality of Life of the patients (QoL).~   "
58297|NCT02803827|"~     Many children admitted to hospital in Botswana without bloody diarrhoea are presumed to have~     viral gastroenteritis and so not treated with antibiotics - but they may indeed have a~     treatable cause for their illness. The investigators will conduct a randomized trial to see~     if rapid testing using novel methods to identify potentially treatable causes of diarrhoea~     leads to improved outcomes. The investigators will also be randomizing children to~     Lactobacillus reuteri DSM (daughter strain) 17938 therapy versus placebo (the standard of~     care) to see if this treatment decreases the duration of diarrhoea. The proposed study is a~     large multi-centre trial following the previous pilot trial.~   "
58298|NCT02803814|"~     Background: Recently it has been observed in pancreatic cancer that after apparently complete~     surgical resection, histological examination of the surgical specimen according to a standard~     protocol reveals tumor infiltration of the surgical margin in more than 50% of patients. To~     increase the resection margin and reduce such high infiltration rate, a new surgical approach~     based on the initial dissection of the superior mesenteric artery has been advocated.~      Aims: To compare the rate of free resection margin (R0) and oncological results of two~     possible approaches to perform a pancreaticoduodenectomy in tumors of the head of the~     pancreas and peripancreatic area: the classic approach versus the initial approach of the~     superior mesenteric artery.~      Methodology: Prospective, randomized, multicenter study in which patients with pancreatic and~     periampullary tumors undergo a pancreaticoduodenectomy. In a group the classical approach~     from the superior mesenteric vein will be performed and in the other group an initially~     dissecting the superior mesenteric artery approach will be carried out. 116 patients are~     required and the main variables considered are: free margin rates (R0) or infiltrated by~     tumor (R1), postoperative morbidity, mortality, local and systemic recurrence, disease-free~     interval and survival at 1, 3 and 5 years.~   "
58299|NCT02803801|"~     This pilot project is a cooperative effort between the Leisure in Fun Environments (LIFE)~     Program and the Specialized Communication Resources for Children (SCRC) Program at the~     Rehabilitation Centre for Children (RCC). The investigators will blend and enhance two~     pre-existing programs in order to provide a new, specialized program for parents of children~     with ASD or developmental delay. The two programs that will be blended together are~     Promoting Flexible Thinking and Interaction with Your Child at Home and Saturday Cooking~     Club. This new program will be a series of ten workshops that alternates between parents~     only learning sessions and practical cooking club sessions that allow parents to focus on~     practicing what they are learning with their child. These programs are based on the~     principles of Relationship Development Intervention (RDI®), which focuses on providing~     opportunities to establish a guided participation relationship, which will lead to~     development of dynamic intelligence and important social thinking abilities. The program is~     individualized to each child and builds on the principles of typical development to assist~     the child in achieving social competence. Using this program, children are expected to~     develop sociability in a naturally progressing order of complexity.~   "
58300|NCT02803788|"~     -  To study the efficacy and side effects of ondansetron with dexamethasone in patients~          undergoing standard laparoscopic cholecystectomy (control group).~        -  To study the efficacy and side effects of ramosetron in patients undergoing standard~          laparoscopic cholecystectomy (study group).~        -  To compare the efficacy and side effects of ondansetron with dexamethasone and~          ramosetron in patients undergoing standard laparoscopic cholecystectomy~   "
58331|NCT02803385|"~     This study aims to compare the efficacy of pain control, the consumption of local anesthetic~     and opioids, side effects, and patient satisfaction between continuous epidural infusion and~     patient controlled epidural analgesia after thoraco-abdominal surgeries in cancer patients.~   "
58332|NCT02803372|"~     The purpose of this study is to investigate whether circulatory management based on~     LiDCOrapid hemodynamic monitoring can reduce the incidence of acute kidney injury in patients~     undergoing partial nephrectomy when compared with routine circulatory management based on~     blood pressure and urine output monitoring~   "
58479|NCT02801461|"~     The shock wave is a new and potential intervention for the reinnervation of peripheral nerve.~     The purpose of this study was to assess the effect of extracorporeal shock wave therapy on~     cubital tunnel syndrome.~   "
58301|NCT02803775|"~     Cardiac resynchronization therapy (CRT) is a well established clinical therapy for patients~     with symptomatic left ventricular systolic dysfunction and electrocardiographic QRS duration~     of 120 ms or greater. Multicenter trials have consistently demonstrated CRT non responder~     rates of 32-43% at 6 months. Subsequent studies have shown that utilizing~     echocardiographic-guided device reprogramming for optimal atrio-ventricular (A-V) and~     interventricular (VV) delays at rest have improved clinical response. Recently, an~     echocardiographically validated automated pacemaker programmer-based intra-cardiac~     electrogram (IEGM) algorithm has been developed for rapid optimization of sino-ventricular~     (P-V), A-V and V-V delays at resting heart rates that is partially based on the~     interventricular conduction time delays. Nevertheless, controversy still persists as to the~     applicability of both echocardiographic and IEGM derived algorithms at elevated heart rates,~     as with physical activity, when patients are more likely to experience symptoms related to~     poor cardiac output.~      Recent studies have shown clinical benefits of pacing from sites of late intrinsic activation~     or intra-ventricular conduction delays (IVCD). Some studies have utilized the intrinsic~     SENSED IVCD method while others used the right ventricle (RV)-PACED IVCD. There have not been~     any studies to date that compare both methods to determine if one may yield a better clinical~     outcome with lower non-responder rates.~      This study predicts that the RV paced IVCD method will provide better clinical outcomes than~     the longest RV sensed IVCD as determined by the clinical composite score.~      The study is a prospective double blind study with an additional cross-over group consisting~     only of non-responders to compare the clinical response in 72 patients receiving CRT therapy.~     After successful CRT-D implantation and before hospital discharge patients will be randomly~     assigned in a 1:1 fashion to Group 1 (SENSED) or Group 2 (PACED). The patient will complete a~     Minnesota Living with Heart Failure questionnaire, compare echocardiographic data and be~     assessed by a blinded nurse and physician prior to discharge and at each follow up visit to~     maintain the double blind design.~      After 3 months of follow-up, non-responders from each group will be crossed-over to the other~     group and followed for an additional 3 months. Clinical data will be collected at the end of~     that 3 months and compared looking at changes in symptoms, ejection fraction (EF) and other~     echocardiographic measurements, New York Heart Assocation Function Class ( NYHA) class,~     clinical composite scores (CCC), device interrogation data and hospital admissions between~     the two groups to see if there is a statistical difference.~   "
58302|NCT02803762|"~     This study is an open-label, absorption, metabolism, excretion, and mass balance study of 400~     mg [14C]pacritinib (containing 100 μCi radioactivity) administered orally as a single dose to~     6 healthy male subjects following at least a 10-hour fast (not including water) on Day 1.~   "
58303|NCT02803749|"~     Anxiety is highly prevalent in Parkinson's disease and negatively impacts quality of life yet~     it frequently remains untreated and there have been no clinical trials dedicated to~     evaluating the pharmacological treatment of anxiety in Parkinson's disease. Buspirone is~     effective for the treatment of generalized anxiety disorder in the general and elderly~     population. It is not known if it is effective for the treatment of anxiety in Parkinson's~     disease. This is a single-center, placebo-controlled, double-blind design with participants~     randomized with a 4:1 allocation ratio to flexible dosage buspirone (maximum dosage 30 mg~     twice daily) or placebo for 12 weeks.~   "
58304|NCT02803736|"~     This multicenter placebo-controlled trial focuses on the efficacy and safety of acupuncture~     on breast-cancer related lymphedema. 200 participants will be recruited, and randomized in~     two groups: the real acupuncture group and the sham acupuncture group.~   "
58305|NCT02803723|"~     Holding-cuddling plus oral sucrose versus oral sucrose for reducing venipuncture pain in~     newborns and infants.~      Neonates and infants routinely undergo venipuncture in pediatric and neonatal intensive care~     units.~      Such procedure is painful and several units administer 24% oral sucrose with pacifier during~     venipuncture, as this non-pharmacological intervention is considered safe and effective for~     procedural pain relief in infants from birth to 3 months of age. However, several studies~     point out that further research is needed to assess its efficacy in combination with other~     behavioral interventions for analgesia during painful procedures. Current knowledge suggests~     that multisensorial stimulation associated with oral sucrose could allow even more effective~     analgesia. To date, the studied stimulation strategies are based on massage, voice, eye~     contact and fragrance during heel prick. The holding-cuddling - that is the fact of holding~     the child in a safe, reassuring and warm position during the examination or medical~     intervention is promoted by various hospitals in order to favor the comfort of all the~     caregivers during such a procedures. This intervention should be primarily parents-driven~     but, in case of unavailability, it can be performed by the nursing staff. The hypothesis of~     this study is that the combination of holding-cuddling plus oral sucrose in more effective~     than oral sucrose in diminishing behavioral pain response during a venipuncture in newborns~     or infants less than three-month-old.~   "
58306|NCT02803710|"~     Upon penicillins' introduction, inactivation of beta- lactam antibiotics by enzymes produced~     by bacteria was demonstrated. Until recently, carbapenems were a relatively spared subclass~     by these enzymes which makes the molecules of last resort in serious infection. Recently the~     prevalence of enzymes hydrolysing carbapenem, the carbapenemases, was increasing in some~     countries. But these carbapenemases are not the only mechanism involved in a decreased~     susceptibility to carbapenems which is sometimes linked to the conjunction of several~     resistance mechanisms. Data available on the epidemic situation of this new resistance are~     essential for improving their detection, the management of infections in patients and prevent~     the occurrence of epidemic. In this context, the investigators propose a study in the~     North-East inter-region to estimate the prevalence of Enterobacteriaceae with decrease~     susceptibility to carbapenems and look for risk factors for infection with this type of~     bacteria. The study is conducted in five teaching hospitals (Besançon, Dijon, Nancy, Reims~     and Strasbourg) and two general hospitals (Colmar and Troyes) in North-Eastern France. For~     one year, all the Enterobacteriaceae isolates with a decreased susceptibility to carbapenems~     (CDSE) according to the 2012 Antibiogram Comity of the French Microbiology Society (CA-SFM)~     (MIC of ertapenem > 0.5 μg/mL) are collected and sent to the bacteriology laboratory of the~     Reims University Hospital. Among these strains 105 are randomly selected. The clinical study~     is conducted as follow: for each patient with CDSE isolate included in a center, 2 control~     patients are selected. They are the patients having the 2 Enterobacteriaceae isolates, with~     no reduced susceptibility to carbapenems and following the CDSE isolate in the same center.~      Microbiological study : identification of isolates is performed using MALDI-TOF (Bruker~     Daltonics, Bremen, Germany). Antibiotic susceptibilities is determined by the disc diffusion~     method according to European Committee on Antimicrobial Susceptibility Testing (EUCAST)~     guidelines (www.EUCAST.org) and extended-spectrum beta-lactamase (ESBLs) are detected by the~     double-disc synergy test and carbapenem minimal inhibitory concentrations (MICs to Imipenem,~     Ertapenem, Doripenem and Meropenem) determined using E-test® strips. Metallo-β-lactamase~     production was screened with the MβL Etest (bioMérieux, Marcy l'Etoile, France).~     Beta-lactamases detected using polymerase chain reaction (PCR). Carbapenemase-encoding genes~     (blaKPC, blaVIM, blaIMP, blaNDM, blaOXA-23-like, blaOXA-24-like, blaOXA-58-like and~     blaOXA-48-like) were screened using multiplex PCRs and blaIMI and blaGES with simplex PCRs.~     All the blaOXA-48-like detected were subsequently sequenced. Genes blaTEM, blaSHV, blaCTX-M~     and blaOXA were detected by PCR using specific primers. Plasmid-mediated AmpC-type genes~     blaACC, blaFOX, blaMOX, blaDHA, blaCMY and blaMIR were screened using multiplex PCRs. All the~     beta-lactamases are sequenced. Mutations in the quinolone resistance determining region~     (QRDR) are identified by PCR and sequencing in the gyrA, gyrB, parC and parE genes. Qnr and~     qepA genes are detected by real-time PCR, aac(6')-Ib-cr by pyrosequencing and oqxAB by~     conventional PCR. Genotyping is performed with pulsed-field gel electrophoresis (PFGE) and~     multilocus sequence typing (MLST).~      Statistical analysis : qualitative variables are analysed with the Chi2 test and the~     two-tailed Fisher exact test. Quantitative variables are compared using the Mann-Whitney~     test. Then, a multivariate analysis is conducted: logistic regression with stepwise factors~     as explanatory variables with p <0.20 in the univariate analysis as input threshold and~     output set at 0.20.The results are considered statistically significant when P < 0.05.~      Expected results : this study will give the proportion of the different species involved, of~     the carbapenemase in comparison to the other mechanisms, the level of resistance in MIC. Risk~     factors such as previous antibiotic treatment, underlying disease severity or clonal strain~     transmission will be evidenced, allowing to identify prevention control measure to implement.~   "
58307|NCT02803697|"~     Non functioning pituitary adenomas (NFPAs) are the most common pituitary adenomas. Their~     growth is usually slow and diagnosis is often made in the context of masse effect .The~     therapeutic alternatives are surgery and radiotherapy such as fractionated stereotactic~     radiotherapy. Nowadays, there is no clinical or histological prognostic factor to allow an~     individualized follow-up and recurrence could happen 10 or 15 years after the first surgery.~     In this study, the investigators evaluate NFPAs recurrence rate after surgery and try to find~     predictive factors of recurrence to personalized the follow-up of each patient.~   "
58308|NCT02803684|"~     While renal graft outcomes were really improved for the last decade, long time outcomes~     remains stable. Indeed, at 10 years after transplantation, the renal graft survival rate~     reaches 50%. The chronic allograft nephropathy is the main cause of renal graft loss. Other~     features such as acute allograft rejection, delayed renal recovery and anti-human leukocyte~     antigen (anti-HLA) antibodies are associated with poor renal graft survival prognosis. Renal~     graft protocol biopsies at 3 and 12 months after transplantation are valuable to detect~     precociously renal injuries at a reversible stage before clinical manifestation. However,~     renal biopsy is an invasive examination with hemorrhagic risk. Diffusion MRI could be a~     non-invasive diagnostic tool allowing the early detection of renal injuries, especially~     allograft rejection without hemorrhagic risk. This tool could be applied routinely to the~     renal allograft recipient in replacement of protocol biopsies.~      Here, aim of this study is to correlate the results from diffusion MRI of renal graft with~     pathologic findings from protocol renal graft biopsies.~      In this view, the investigators include prospectively all recipients of renal transplantation~     who beneficiate of a protocol renal graft biopsy without barrier to peform MRI examination.~     Thus, the investigators exclude patients who are not be able to beneficiate of a MRI~     examination and patient obstacle to renal graft biopsy.~      Expected results are the Banff classification from the histopathologic analysis of biopsies.~     The expected results for MRI examination are signal intensity, diffusive coefficient,~     anisotropy fraction and change of the diffusion way. Next, the investigators search an~     association between these features by statistical analysis (Wilcoxon test, Chi², Fisher,~     Pearson or Spearman).~      The investigators performed this study since 01/06/2014 and projected end-time to 01/06/2017.~   "
58346|NCT02803190|"~     The investigators' previous studies in 2014 and 2015 have demonstrated that among~     community-dwelling older adults with high osteoporotic fracture risks. many sarcopenia~     indices can be improved and bone mineral density (BMD) maintained with different exercise~     programs. In 2016, the investigators aim to determine the effects of 2 exercise interventions~     on posture corrections and further improvement of sarcopenic indices~   "
58347|NCT02803177|"~     In the present phase-II clinical trial the researchers investigate efficacy and proof of~     concept of the augmentation with preoperatively isolated autologous BMC cells seeded onto~     ß-TCP in combination with an angle stable fixation (Philos plate®) for the therapy of~     proximal humeral fractures.~   "
58310|NCT02803658|"~     About 15% of couples consult for difficulties achieving pregnancy. In about two-thirds of~     cases, a male component is identified, but is not always sufficient to explain infertility.~     In the majority of cases, the cause cannot be clearly identified and multiple abnormalities~     may be detected in both partners.~      Many factors concerning lifestyle and environment (medications, alcohol, smoking, pollution,~     exposure to heat, toxins, xenobiotic oestrogens, etc.) may impact on fertility. These factors~     may also impact on the fertility of the children conceived, which is described as an~     intergenerational effect (alteration of the fertility of boys exposed to smoking in utero).~      Few scientific studies with a high level of proof have been published on the impact of~     smoking on the couple's fertility. Gonadal functioning and the quality of gametes can be~     altered by these environmental factors, which may trigger a process of apoptosis or~     alteration of the DNA of gametes (sperm DNA fragmentation). Other modifications include DNA~     methylation and histone acetylation, which control gene expression and are grouped under the~     term epigenetic modifications. More recently, oestrogens has been shown to be involved in~     male reproductive function by acting on spermatogenesis, spermiogenesis and epididymal~     maturation. Demonstration of an active aromatase (Arom) (mRNA, protein and activity) in~     ejaculated human spermatozoa suggests the synthesis of small quantities of oestrogens in~     spermatozoa. The study of transcript profiles could provide information about the quality of~     spermatogenesis and/or spermiogenesis and during the first steps of embryonic development.~     Confocal microscopy has colocalized the aromatase on the head, midpiece and tail and can be~     used to assess the quality of the acrosome with anti-CD-46 monoclonal antibody. Even low~     concentrations of xenobiotic oestrogens can exert biological effects on certain functions of~     murine or human spermatozoa, accelerating capacitation and the acrosome reaction. These~     factors are all the more effective when they act in combination, as human gametes appear to~     be more sensitive to their action than murine gametes All studies conducted to date have~     investigated the impact of toxins either on one of the partners or in the children born to~     the couple. No detailed and high-level scientific study has studied both partners and the~     quality of their embryos.~   "
58311|NCT02803645|"~     Antiphospholipid (APL) antibodies are a heterogeneous family of auto-antibodies,~     predominantly represented by anticardiolipin (ACL) antibodies and lupus anticoagulant (LA).~     Antiphospholipid syndrome (APS) is defined as the presence of APL associated with venous~     and/or arterial thrombosis or repeated foetal loss. APS may be either primary or secondary to~     an autoimmune disease, mainly systemic lupus erythematosus (SLE). However, other than in the~     context of APS, APL can also be observed in various clinical situations and in healthy~     subjects. Published studies have reported a variable prevalence of APL in healthy subjects,~     essentially ACL and/or LA, and their clinical significance currently remains unclear.~      Several studies have highlighted the link between APL and atherosclerosis. It therefore~     appears interesting to more specifically study the association between the presence of APL~     and the presence of cardiovascular risk factors in a population of healthy subjects.~     Atherosclerosis is currently considered to be a chronic inflammatory disease arising from a~     complex interaction between atherogenic plasma factors and cells of the arterial wall.~     Several inflammatory markers are now known to be associated with cardiovascular risk. Lipid~     peroxidation also plays a major role during the atherogenesis process. It will therefore also~     be important to correlate APL with markers of vascular inflammation and markers of oxidative~     stress.~      A prospective case-control study will therefore be conducted on 1,500 healthy blood donors.~     Subjects screened APL-positive will be compared to APL-negative subjects in terms of~     cardiovascular risk factors (cardiovascular risk per se, the presence of cardiovascular~     disease will not be studied). In the context of a blood donation, all subjects wishing to~     participate in this study will attend a medical interview and a clinical examination during~     which various data will be collected, mainly the presence of cardiovascular risk factors. A~     blood sample will also be taken to assay the various laboratory markers studied.~      This study should provide a better understanding of the role of APL in healthy subjects and~     more clearly specify their possible link with atherosclerosis in this population.~   "
58312|NCT02803632|"~     An excess suicide-related morbidity is observed among young people in the Picardie region, as~     reflected by the > 100% occupation rate of the Amiens University Hospital Adolescent Medicine~     Unit. New approaches have been proposed to these problems that have led us to reorganize our~     diagnostic practices: 1) more precise characterization of suicidal behaviour by using~     standardized instruments such as the French version of the Columbia-Suicide Severity Rating~     Scale developed by Posner (C-SSRS); 2) new clinical entities, such as disruptive mood~     dysregulation disorder, are now proposed in international classifications (DSM 5 field~     trial); 3) investigations such as recording of the circadian rhythm of motor activity by~     actigraphy are being studied as a laboratory complement to psychiatric diagnosis.~   "
58313|NCT02803619|"~     Leptomeningeal metastasis (LM) is one of the disastrous events when managing advanced~     Non-small cell lung cancer (NSCLC) due to a grave prognosis. Although intrathecal (IT)~     chemotherapy and brain and/or spinal axis irradiation show some effects for LM in advanced~     NSCLC, the prognosis is still poor with median survival less than 12-14 weeks. Epidermal~     growth factor (EGFR) tyrosine kinase inhibitors (TKIs) showed to be effective for LM in~     selected NSCLC patients in some retrospective research. Our single-center prospective~     research indicated that the incidence of EGFR sensitive mutations (EGFRm+) in NSCLC-LM~     patients was high and EGFR-TKIs showed a survival benefit for LM in EGFRm+ NSCLC patients. A~     multi-center prospective observational biomarker study will be started in 11 lung cancer~     center based on our single-center prospective research result. The aims of the study are to~     find predictive biomarkers for LM in advanced NSCLC, to establish EGFR-TKIs based~     comprehensive treatment for appropriate EGFRm+ LM cases, and to establish effective clinical~     assessment criteria for NSCLC-LM EGFR-TKIs treatment.~   "
58314|NCT02803606|"~     Preterm neonates less than 32 weeks of gestational age admitted at birth to the Neonatal~     Medicine unit will be included after informing the parents. Abdominal skin and peripheral~     (arm or leg) and incubator air temperatures and relative humidity will be obtained from data~     recorded by the incubator without using any additional transducer compared to standard care.~     Pulse and respiratory rate, blood pressure, the incidence of apnoeas and sleep organization~     will also be recorded from routine monitoring. A case report form and a wide-angle video~     recording of the infant's room will allow description of the type of care, determine the~     duration of care and the impact on incubator function. Data will be recorded for the first 7~     days of life of the preterm neonate.~   "
58315|NCT02803593|"~     The purpose of the proposed randomized intervention study is to test the efficacy of the~     technology-based information and coaching/support program for Asian American breast cancer~     survivors (TICAA) in enhancing the women's breast cancer survivorship experience at three~     time points (pre-test, post1-month, and post 3-month).~   "
58316|NCT02803580|"~     The purpose of the present study is to evaluate the characteristics, management and clinical~     course of patients with IPF as treated under real-world in Italian Pulmonary Centres, in~     terms of symptoms, lung function and exercise tolerance during 12 months of observation.~   "
58317|NCT02803567|"~     The primary goal of this project is to develop a tailored screening, brief intervention and~     referral to treatment (SBIRT) model for youth with chronic medical conditions (YCMC) for~     delivery at point of care during a routine healthcare visit, through conducting a rigorous~     randomized control trial among adolescent patients with type 1 diabetes (TID) or~     rheumatologic conditions. The secondary goal is to assess the attitudes and knowledge of~     parents of these same adolescents, to explore links between parent beliefs and adolescent~     behavior around substance use.~   "
58318|NCT02803554|"~     The purpose of the study is to evaluate the beneficial effects of infusions of plasma from~     young donors using blood biomarkers.~   "
67597|NCT02682160|"~     The aim of this study is to evaluate the effect of the use of Protein Assistant on the daily~     protein intake in obese patients who underwent a bariatric surgery (in the 3 months following~     surgery).~   "
58319|NCT02803541|"~     Purpose: Most children and adolescents with chronic kidney disease (CKD) have much less~     physical endurance than their age matched peers, are at high risk for premature~     cardiovascular disease, and have a poor self image in part due to limited peer contact.~     Sustained exercise in adults with CKD improves endurance and decreases cardiovascular risk.~     Minimal data exists in pediatric CKD patients. This study will show whether 12 days of~     increased exercise at a summer camp will improve endurance as measured by the distance walked~     in 6 minutes and self concept as measured by a short standardized questionaire (Harter~     scale).~      The study will occur at the Frost Valley YMCA in the Catskills where in 2, 12 day sessions a~     total of 25-30 kidney campers are mainstreamed in the general camp population of about 500.~      Mainstreaming means that the kidney camper will live in a cabin with 8-10 age matched peers~     and participate as much as possible in all camp activities with their bunkmates. The kidney~     program at Frost Valley provides hemo and peritoneal dialysis, as well as caring for children~     with less advanced CKD and post transplant.~      Participants will have activity measured before and duringcamp by wearing a pedometer. The~     distance walked in 6 minutes (a 6 minutewalk test) will be measured at onset and completion~     of the 12 day camp experience. A standardized questionaire on self concept will also be~     administered at the onset and completion of camp.~   "
58320|NCT02803528|"~     Comparative study between Biodentine and MTA in direct pulp capping of deeply carious teeth.~   "
58321|NCT02803515|"~     Peritoneal carcinomatosis (PC) is the stage III of the FIGO ovarian cancer staging. It~     corresponds to an advanced stage with a relative 5 year survival rate of 52%. The multimodal~     treatment approach combines neoadjuvant chemotherapy, cytoreductive surgery of macroscopic~     lesions, and hyperthermic intraperitoneal chemotherapy (HIPEC). It has significantly improved~     survival rate in patients with ovarian PC and decreased recurrence and mortality rate by 21%.~     The efficacy of HIPEC is based on chemotherapy potentiated by the hyperthermia (43°).~     However, the cellular mechanisms involved are not fully understood, but they include cell~     death pathways and heat shock proteins (Hsp70 and Hsp90). RICCI et al. showed, based on~     pre-clinical models, that the efficacy of HIPEC was partly due to the overexpression and~     exposure of HSP90 on the cell surface leaded to an anti-cancer immune response. The aims of~     this study are to validate these findings in tissue samples of patients with ovarian PC. We~     will constitute a bank of isolated tumor samples before and after HIPEC and measure~     postoperative HSP90 serum levels in order to establish if they are predictive of a response.~     HSPs expression on the cancer cell surface will be determined by flow cytometry. Forty-four~     patients will be included. Elucidating the underlying mechanisms of HIPEC will broaden~     therapeutic possibilities including the use of new immunotherapy. The multimodal approach~     could improve the efficacy of HIPEC with a minimal systemic toxicity.~   "
58322|NCT02803502|"~     In the context of hemophilia, it is well know that the level of factor VIII alone does not~     reflect the clinical phenotype of the patients in an accurate way. At equal factor VIII~     levels, certain patients will bleed more than others.~      The thrombin generation test (TGT) is a test that seems to provide a better prediction of the~     overall hemostatic status of an individual patient. In a previous study, the investigators~     have established normal reference values of the thrombin generation curve in children aged 6~     months to 16 years and adults. The goal was to evaluate the use of this test in different~     clinical contexts and in severe hemophilia patients in particular. A pilot study showed that~     the patients having a thrombin generation <150 had a severe phenotype, whether those who~     received an appropriate prophylaxy had a thrombin generation superior to 150.~      Moreover, the investigators now have access to a software tool that allows them to~     individually determine the pharmacokinetic profile of the factor VIII injected to each~     patient. The factor VIII concentration is measured at injection and 30 minutes, 1 hour, 2~     hours and 24 hours afterwards. The introduction of these concentrations in the software~     allows to obtain the half-life of factor for a given patient, the maximum peak, and the~     minimum factor level (though level). The injected dosis might be sufficient (disappearance of~     substantial diminution of the bleedings) or unsufficient (persisting bleeding) for a given~     patient.~      This study aims:~        -  to measure the pharmacokinetic profile of factor VIII by two different methods, the~          time-based method and the chromogenic method~        -  to correlate the results with the TGT results obtained at the same time points and~          determine which method gives the best correlation~        -  to link the clinical symptomatology (improved symptomatology or not) with the TGT~          results~        -  to determine which minimal TGT result is linked to a minimal bleeding rate~        -  to adapt the prophylactic dosis of the patient in a personalized way.~   "
58323|NCT02803489|"~     Prospective, non-randomized, open-label, pilot study conducted in a single group of 30~     evaluable patients, i.e. patients completing an approximate 3 month follow-up.~   "
58324|NCT02803476|"~     The primary aim of the current study is to clarify whether serum vitamin D levels [25(OH)D3]~     have a temporal association with insulin resistance and/or insulin sensitivity in PCOS women~     versus healthy ones.~      To achieve this aim, the investigators will conduct a prospective observational study~     involving obese and lean PCOS women in comparison to obese and lean healthy subjects living~     in Cairo, Egypt.~   "
58325|NCT02803463|"~     There has been no consensus over closure versus non closure of peritoneum during abdominal~     operations. The aim of this study is to compare the effect of peritoneal closure versus non~     closure over postoperative pain, early complications and life quality.~   "
58326|NCT02803450|"~     This prospective, randomized, single blinded control trial will investigate the effects of~     epidural loading with a high volume, low concentration local anesthetic solution via the~     epidural needle versus the epidural catheter.~   "
58327|NCT02803437|"~     This study is a Japanese post-marketing surveillance (PMS) which is required by the~     regulatory authorities. General objective of PMS is to confirm the clinical usefulness,~     especially the safety profile of a drug under the routine clinical practice.~   "
58328|NCT02803424|"~     The steep trendelenburg position and pneumoperitoneum during laparoscopic surgery have the~     potential to cause an adverse effects on respiratory mechanics and gas exchange.~     Autoflow-volume controlled ventilation may improve lung compliance and reduce airway peak~     pressure. Therefore, the aim of this study is to evaluate whether Autoflow-volume controlled~     ventilation improves gas exchange and respiratory mechanics in patients undergoing~     robot-assisted laparoscopic radical prostatectomy.~   "
58329|NCT02803411|"~     To describe the natural history of the coronary atherosclerotic plaque development and~     progression over time by CCTA with demographic and laboratory data for refinement of risk~     stratification of patients referred for CCTA.~   "
58330|NCT02803398|"~     The aim of the study is to measure and model interface pressure applied on the lower leg of~     patients at risk of veinous thrombosis, by different bandage combinations, composed of Biflex~     16 (Thuasne) and/or Rosidal K (Lohmann & Rauscher). The patient specific model should better~     predict the interface pressure distribution than Laplace's Law.~   "
69584|NCT02656160|"~     In this protocol the investigators will test the effect of dalfampridine (a potassium channel~     blocker) on genioglossus muscle activity (EMG GG) during wakefulness and sleep in healthy~     control subjects.~   "
58333|NCT02803359|"~     The primary purpose of this study will be to determine whether the proposed study protocol~     will allow for reliable detection of the human Laryngeal evoked brainstem responses (LEBR).~     Laryngeal evoked brain stem responses will be recorded from five test subjects under general~     anesthesia in the operating room with the assistance of an electrophysiologist with expertise~     in evoked potentials. Once the feasibility of obtaining tracings are established on the first~     few subjects, responses will be recorded from other test subjects with the aim of determining~     the optimal placement of stimulating electrodes and detection leads necessary to elicit an~     adequate response. The effect of varying the stimulus intensity will also be studied. Once~     parameters for testing have been standardized, normative configurations for the laryngeal~     evoked brainstem response tracings can be determined by patients both in the office setting~     and in the operating room.~   "
58334|NCT02803346|"~     Septic syndromes (systemic inflammatory response associated with infection) remain a major~     although largely under-recognized health care problem and represent the first cause of~     mortality in intensive care units. While it has long been known that sepsis deeply perturbs~     immune homeostasis by inducing a tremendous systemic inflammatory response, novel findings~     indicate that sepsis indeed initiates a more complex immunologic response that varies over~     time, with the concomitant occurrence of both pro- and anti-inflammatory mechanisms. As a~     resultant, after a short pro-inflammatory phase, septic patients enter a stage of protracted~     immunosuppression. This is illustrated in those patients by reactivation of dormant viruses~     (CMV or HSV) or infections due to pathogens, including fungi, which are normally pathogenic~     solely in immunocompromised hosts. These alterations might be directly responsible for~     worsening outcome in patients who survived initial resuscitation as nearly all immune~     functions are deeply compromised. Both arms of immunity (innate and adaptive) are indeed~     markedly suppressed (including enhanced leukocyte apoptosis, lymphocyte anergy and~     deactivated monocyte functions). New promising therapeutic avenues are currently emerging~     from those recent findings such as adjunctive immunostimulation for the most immunosuppressed~     patients. The prerequisite for immunostimulation administration (IFNg, GM-CSF, IL-7) however~     relies on the investigators capacity in identifying the patients who could benefit from it,~     as there is no clinical sign of immune dysfunctions. The main objectives are:~        1. to identify the best biomarkers for sepsis-induced immunosuppression and~        2. to evaluate ex vivo whether drugs could rejuvenate immune functions.~   "
58335|NCT02803333|"~     The Moffitt Cancer Center and PatientsLikeMe.com (PLM), an online patient community, are~     working together to better understand the patient's entire lung cancer experience, both~     inside and outside the doctor's office. By combining the data that is captured by their care~     team in the clinic with the data participants enter at their home on PatientsLikeMe.com, the~     investigators hope to improve patient-physician treatment decisions, so that the patient's~     personal treatment goals and quality of life have the highest chances of being fulfilled.~   "
58336|NCT02803320|"~     The objective of this study was to assess the safety and appropriateness of a sunscreen~     product for use on sport users, under supervised outdoor use conditions.~   "
58337|NCT02803307|"~     This trial is a multi-site, randomized, open-label, parallel, and single-dose administration~     study to investigate the safety and efficacy of TLC599 in subjects with osteoarthritis of the~     knee.~   "
58338|NCT02803294|"~     The purpose of this study is to evaluate the safety and effectiveness of transcatheter aortic~     valve replacement in Chinese population.~   "
58339|NCT02803281|"~     Determine the feasibility of assessment of measures of frailty and determine if these~     measures provide a clinically important contribution of risk assessment in a population of~     patients undergoing major thoracic surgery for lung or esophageal cancer.~   "
58340|NCT02803268|"~     A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of~     MT-8554 in Female Subjects Experiencing Vasomotor Symptoms~   "
58341|NCT02803255|"~     The purpose of this study is to demonstrate that a robot-aided rehabilitation protocol that~     follows the assist-as needed paradigm provide statistically significant improvements in arm~     and hand motor functions when compared to robot-aided protocols that passively move patients'~     arms along pre-defined trajectories, in patients with incomplete spinal cord injury (SCI).~   "
58342|NCT02803242|"~     The COPD Patient-Powered Research Network (COPD PPRN) is a patient research registry with the~     goal of enrolling 75,000 or more COPD patients and those at risk who are willing to share~     their heath information over several years and participate in research. The COPD PPRN has~     built an online platform to allow volunteers to enroll electronically, complete surveys, be~     contacted about studies they qualify for and become connected to COPD resources. The goal of~     the registry is to speed research to find better treatments for COPD and ultimately a cure.~   "
58343|NCT02803229|"~     The proposed protocol is a double-blind, placebo-controlled outpatient study of the safety~     and benefit of Extended-release mixed amphetamine salt (Adderall-XR, MAS-XR) in the treatment~     of individuals with Cannabis Use Disorder (CUD) and Attention-deficit/Hyperactivity Disorder~     (ADHD). The investigators plan to enroll 50 and randomize 40 of these patients in the trial.~     The primary objective of the study is to determine the efficacy of MAS-XR in promoting~     cannabis abstinence among individuals with CUD and in promoting a decrease of ADHD symptoms.~   "
58344|NCT02803216|"~     To evaluate the efficacy and safety of Traditional Chinese Medicine (TCM) decoction and~     powder combined with standard triple therapy on improving eradication rate of Helicobacter~     Pylori (H. pylori).A multi-center randomized control clinical trial design was adopted in the~     trial.~   "
58345|NCT02803203|"~     The purpose of this study is to test the safety of combining the drugs osimertinib and~     bevacizumab at different dose levels. The investigators want to find out what effects, good~     and/or bad, taking osimertinib and bevacizumab has on the patient and lung cancer. This study~     will try to find the best dose of osimertinib and bevacizumab given together that does not~     cause significant side effects. Once the investigators determine that combining osimertinib~     and bevacizumab is safe, they want to see if the combination is effective in treating lung~     cancers with the EGFR mutation.~   "
58348|NCT02803164|"~     Vacuum-assisted dressings (V-AD) are effective in treating patients with open chest wounds~     (OCW) and will decrease the time-to-closure of such wounds when compared to a historical~     cohort of patients managed by traditional wound care management.~   "
58349|NCT02803151|"~     Lymph node metastasis is one of the most common sites to develop disease recurrence or~     progression after initial local treatment for primary solid malignancies or systemic~     treatment for advanced metastases. No specific treatment modality has been established as the~     standard therapy. Systemic therapy is usually considered since lymphadenopathy is considered~     as a sign of disease dissemination though aggressive local treatment, including surgical~     lymphoadenectomy or radical radiotherapy might result in long-term survival in selected~     patients. The concept of stereotactic ablative radiotherapy (SABR), a high dose of radiation~     targeted to a pathological entity and delivered in a few fractions, has proven so successful~     at treating both benign and malignant lesions that it changed the paradigm for radiation~     therapy. The radiobiology of SABR has been shown to be very favorable for tumor control.~     Clinical experiences suggested that SABR might offer excellent in-field tumor control with~     low toxicity profile in selected patients, although the majority of reports are retrospective~     and include small patients series with heterogeneous tumor sites and dose-fractionation~     schedules.~      At present, there is lack of validated prognostic factors to identify the patients who might~     benefit most from ablative local therapy for metastatic lymph node(s). The mechanism of~     effect of SABR on the cancer lesions is not yet clear. Apart from its direct effect on~     clonogenic cancer cells, an immune-mediated process was also hypothesized. Therefore, the~     present study is aimed to provide a better understanding about utilization of SABR for~     metastatic lymph node(s). The associated translational researches will also advance our~     knowledge in the immune system reactions to SABR.~   "
58350|NCT02803138|"~     The interferon-free combination regimen of Paritaprevir/r - Ombitasvir with or without~     Dasabuvir (ABBVIE REGIMEN) ± Ribavirin (RBV) for the treatment of chronic hepatitis C (CHC)~     has been shown to be safe and effective in randomized controlled clinical trials with strict~     inclusion and exclusion criteria under well controlled conditions.~      This observational study is the first effectiveness research examining the ABBVIE REGIMEN ±~     RBV, used according to local label, under real world conditions in Israel in a clinical~     practice patient population.~   "
58351|NCT02803125|"~     The purpose of this project is to develop an intervention to improve psychosocial functioning~     and quality of life for older Veterans with partial or full PTSD.~   "
58352|NCT02803112|"~     The investigators aim to retrospectively map the delays in the acute care of traumatic brain~     injury patients necessitating emergent craniotomies.~   "
58353|NCT02803099|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
58354|NCT02803086|"~     The prophylactic irradiation of pelvic lymph-nodes by means of Whole-Pelvis Radiotherapy~     (WPRT) in the treatment of prostate cancer (PCa) is aimed at the timely eradication of~     microscopic lymph-nodal metastases. Nevertheless, even though delivered by means of modern~     Intensity-Modulated Radiotherapy (IMRT) techniques, WPRT may result in intestinal,~     hematologic and urinary toxicity (IT, HT, UT, respectively) severely affecting patients'~     daily health-related quality-of-life (HRQoL) within the so-called and inadequately~     investigated Pelvic Radiation Disease.~      The aim of this study is to develop sophisticated predictive models of IMRT-WPRT induced~     patient-reported HT, IT and UT in PCa. The possible correlation between several clinical~     factors and radiation doses received by various pelvic structures (i.e. pelvic bones~     subvolumes, intestinal loops, sigmoid, rectum and bladder) and risk and severity of~     patient-reported IT, UT and HT will be analyzed and robust multi-variable models will be~     developed and internally validated. A secondary end-point will be the identification of~     specific symptoms affecting patients' HRQoL during irradiation and in the long term, overall~     and in different therapeutic settings (radical, adjuvant and salvage). Lastly, possible~     correlation between HT and UT/IT will be investigated.~   "
58355|NCT02803073|"~     The purpose of this study is to determine the effects of testosterone replacement in~     hypogonadal men on exercise tolerance and cardiac rehabilitation after an acute myocardial~     infarction.~   "
58356|NCT02803060|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
58357|NCT02803047|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
58358|NCT02803034|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
58359|NCT02803021|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
58360|NCT02803008|"~     To evaluate the Sun protection factor efficacy on human skin.~   "
58361|NCT02802995|"~     The aim of this study is to~        -  To evaluate the safety and tolerability of Platelet Rich plasma(PRP)/Thrombin mixture in~          treating chronic venous ulcers~        -  To evaluate efficacy of PRP/Thrombin mixture in treating chronic venous ulcers~   "
58362|NCT02802982|"~     Parents of infants who have been thrombocytopenic for 3-4 days will be approached for consent~     to enter the study. For the purposes of the study, thrombocytopenia will be defined as a~     platelet count <60,000/uL or a platelet count <100,000/uL that prompted a platelet~     transfusion. Following enrollment, the platelet count will be followed in each infant.~     Participants will enter the study if on day 5 or later after the onset of thrombocytopenia~     (defined as above) infants either have a platelet count <60,000/uL or a platelet count~     <100,000/uL for which a platelet transfusion is ordered.~   "
58363|NCT02802969|"~     Improved local control of chordoma initially treated with surgery or not, thanks to adjuvant~     radiotherapy oriented by conventional imaging Computed Tomography /Magnetic Resonance Imaging~     (CT / MRI) and guided by the [18Fluor] ([18F]) Fluoroazomycin Arabinofuranoside (FAZA)~     Positron Emission Tomography / Computed Tomography (PET / CT) to target the radioresistant~     hypoxic cells.~   "
58364|NCT02802956|"~     Efficacy of Participation in Daily Life Promotion Program for Patients with Chronic Stroke~   "
58365|NCT02802943|"~     The aim of this study is to induce a peptide-specific immune response in CLL patients by~     multi-peptide vaccination with a patient-individualized peptide cocktail.~   "
58366|NCT02802930|"~     The primary objective of this study was to evaluate the potential for phototoxicity of the~     sun care products SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 compared to that of a~     negative control (0.9% sodium chloride [NaCl]) after a single 24 h application of test~     materials followed by irradiation with ultraviolet A (UVA) and ultraviolet B (UVB).~      The secondary objective of this study was to evaluate the safety of the sun care products SPF~     50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 combined with UVA/B irradiation by monitoring~     adverse events (AEs) throughout the study.~   "
58368|NCT02802904|"~     Fats and oils are made up of >90% triacylglycerol fat molecules which consist of a glycerol~     backbone to which 3 esterified fatty acids are attached. The positions of fatty acid~     attachment are referred to by stereospecific numbers, sn -1, -2 and -3. There is existing~     evidence to show that vegetable oils having unsaturated fatty acids in the sn-2 position with~     predominantly palmitic acid (16:0) or stearic acid (18:0) in the sn-1 and sn-3 positions of~     fat molecules do not raise serum cholesterol levels. These observations have come to be known~     as or explained by the sn-2 hypothesis. New evidence have also emerged to show that~     saturated fatty acids (16:0, 18:0) in the sn-1 and -3 positions reduces fat deposition in a~     rat model. In this proposed study, the effects on the outcome measures investigated of three~     test fats [namely palm olein IV64 (POP), virgin olive oil (OOO) and cocoa butter (POS)], with~     oleic acid primarily at the sn-2 position but differing amounts of palmitic, stearic and~     oleic acids at the sn-1/sn-3 positions of the triglyceride molecule, are investigated~   "
58369|NCT02802891|"~     The JOIN project combines the health and indoor environment research areas to contribute in~     the development and validation of a new asthma diagnosis method through exhaled VOC analysis.~     This method is more sensitive, more specific, and completely non-invasive. Moreover, the JOIN~     project will assess the impact of exposure to the indoor environment, namely endocrine~     disruptors, on asthma and allergy development in children.~   "
58370|NCT02802878|"~     The purpose of this study is to assess the efficacy of a 12-week low-load neuromuscular~     electrical stimulation with volitional contraction (NMES-VC) training program to improve~     quadriceps strength and activation, while not adversely affecting knee-related pain,~     activities of daily living or quality of life in women with knee pain. The primary outcome~     will be change in maximal isokinetic knee extensor torque.~      The investigators will test the following hypotheses. In comparison with low-load (40%)~     resistance training without electrical stimulation, a 12-week NMES-VC training program will:~      Hypothesis 1: Increase maximal isokinetic knee extensor torque~      Secondary questions and response variables~      Hypothesis 2: Not adversely affect knee pain or quality of life, assessed by the Knee injury~     and Osteoarthritis Outcome Score (KOOS) questionnaire~      Additional hypotheses in women with risk factors for incident symptomatic or progressive KOA:~        1. Determine the extent to which NMES-VC-enhanced low-intensity resistance training~          increases quadriceps muscle rate of force development~        2. Determine the extent to which NMES-VC enhanced low-intensity exercise is tolerated~          (using numeric rating scale survey level of pain you experienced during the hybrid~          training or 40% isokinetic exercise)~        3. Determine the extent to which NMES-VC-enhanced low-intensity resistance training~          increases physical function (20m walk, chair stand)~   "
58371|NCT02802865|"~     This study evaluates the addition of clomid to letrozole for the treatment of infertility in~     women with polycystic ovary syndrome. Half of the participants will receive letrozole and~     clomid in combination, while the other half will receive letrozole alone.~   "
58372|NCT02802852|"~     Neovascularization (NV) is the innate capability to enlarge collateral arteries~     (arteriogenesis), and to stimulate growth of new capillaries, arterioles and venules at the~     tissue level (angiogenesis). Patients with Chronic Limb-threatening Ischemia (CLI) present~     with forefoot rest-pain, ulceration and/or gangrene. They require risky and costly~     revascularization operations to avoid amputation. The investigators hypothesize that their~     inadequate NV can be modulated to restore this capability. By correcting impediments to NV in~     an out-patient setting, the investigators expect to facilitate CLI management.~      While the following impediments to NV are complex, the solution is not. Arteriogenesis~     necessitates endothelial cell activation in small collaterals as blood is offloaded away from~     the occluded artery. Shear stress provides this stimulus, but is attenuated caudal to~     multi-level arterial occlusive disease. The arteriogenesis switch is not turned on.~     Furthermore, the lack of nutritive oxygenated blood inflow and the accumulation of toxic~     metabolic by-products are adverse to synthetic pathways in the ischemic tissue. Additionally,~     protein distress signals cannot be effectively disseminated by the ischemic tissue, and the~     reparative progenitor cells they are supposed to mobilize cannot effectively home back to the~     ischemic tissue to orchestrate NV. The CLI patient is especially disadvantaged by having~     diminished function and number of circulating progenitor cells (CPC). Lastly these elderly,~     often diabetic, patients are less able to fend off infection.~      An FDA approved external programmed pneumatic compression device (PPCD) was used to restore~     the shear stress stimulus required for arteriogenesis. It also enhances oxygenated nutritive~     arterial inflow, clears waste products of metabolism (increased venous and lymphatic~     outflow), and helps distress proteins reach the central circulation and mobilized progenitor~     cells to return to the ischemic tissue. We corrected the progenitor cell and immunologic~     impairment with granulocyte colony stimulating factor (G-CSF), FDA approved for stem cell~     mobilization and immunological boost in the setting of cancer chemotherapy. The preliminary~     data show clinical, angiographic, hemodynamic and biochemical evidence for enhanced NV. The~     purpose for this study is to enroll 25 patients to reproduce the biochemical data to support~     a large scale clinical trial.~   "
58373|NCT02802839|"~     Children with Cystic fibrosis (CF) have to undergo several needle-related procedures during~     outpatient visits or hospital stay. It is common for children with CF to display distress and~     behavioural problems during invasive procedures. Children with chronic diseases have a lower~     threshold of pain compared to non-chronic patients. Effective management of needle distress~     in children with CF is critical. Although pharmacological and non pharmacological methods are~     used during needle -related procedures to lower painful stimuli nearly all patients with CF~     experience anxiety. Distraction has been shown to be an effective technique that directs~     children's attention away from noxious stimuli. The application of Virtual Reality (VR) in~     the medical field has been shown to be successful already 15 years ago. VR has found its use~     during the medication of burns and in patients undergoing cancer treatments whereas so far~     few studies have been published to assess its efficacy in reducing needle related pain and~     distress in children and none in children with CF.~      Objectives To assess the efficacy of VR in reducing pain and distress during venipuncture in~     children with CF compared to routine care.~      Project description Randomized controlled parallel trial with a 1 to 1 allocation ratio. The~     use of VR compared to standard care during venipuncture in children with CF (age 6-18 years)~     attending the outpatient clinic of the CF Centre of Florence will be compared over the period~     of 1 year. Patients randomly assigned to arm A will use VR during the procedure, those~     patients assigned to arm B will receive routine care.~      Anticipated output Determination of the efficacy of VR in lowering pain and distress during~     venipuncture.~   "
58374|NCT02802826|"~     Chemotherapy forms a significant part of many breast cancer patient's treatment and is~     associated with various common, known adverse effects. For the last few decades, physical~     activity has been emerging as a viable intervention to help many of these adverse effects.~     The study will determine if the provision of a 12-week tailored walking programme, provided~     alongside a home-based exercise prescription from a cancer doctor results in improved levels~     of physical activity and quality of life in patients with breast cancer undergoing~     chemotherapy.~   "
58376|NCT02802800|"~     Field hockey players, recruited from clubs in Jamaica, will be randomized to either a water~     training or land training groups. Persons will be exposed to 6 weeks of plyometric training~     with two sessions per week. Pre and post test measures will be done for lower limb power,~     flexibility and agility. Distance covered, pace, heart rates and exertion during a match will~     also be assessed.~   "
58377|NCT02802787|"~     Implementation and Evaluation of an Activity Based Program to Improve Quality of Life, Pain~     and Fatigue Outcomes in Women Diagnosed With Cancer. Demonstrate improved life satisfaction,~     decreased pain and decreased fatigue (with evidenced gathered at three consecutive periods~     Quality of Life, Pain and Fatigue surveys).~   "
58378|NCT02802774|"~     The management of distal radius fractures has been in a state of evolution over the past 30~     years. Treatment has become increasingly focused on obtaining a stable, internal construct~     for quick return to normal, daily activities. With the advent of volar locking plates, the~     wrist fracture is stable before the patient leaves the operating room. As surgical plate and~     screw constructs become more stable, the need for casting and splinting may be less.~      The presumptive next step in operative management of distal radius fractures is to do away~     with the postoperative splint. A review of the available English language literature failed~     to reveal any studies evaluating the use of postoperative splinting and patient outcomes.~      This prospective, randomized study was designed to investigate the use of temporary plaster~     splints versus removable over-the-counter splits versus soft dressings for post-operative~     treatment of extra-articular and intra-articular distal radius fractures. The patients will~     be followed for 12 months evaluating maintenance of fracture reduction and patient outcomes.~   "
58379|NCT02802761|"~     Study Cohort:~      All Children (Age: 3 months- 18 years, corrected age upto 2 years for preterm children) with~     Chronic Liver Disease attending Pediatric Hepatology Out Patient Department/In Patient~     Department~   "
58380|NCT02802748|"~     VENTANA is a window-of-opportunity trial that will explore whether, similar to CDK4/6~     inhibitors, Oral Metronomic Vinorelbine in combination with Letrozole induces a superior~     anti-proliferative effect than Letrozole alone.~   "
58381|NCT02802735|"~     This two-part study has been designed to evaluate the Pharmacokinetics (PK) of single and~     multiple doses of apremilast in healthy adult male Korean subjects.~   "
58382|NCT02802722|"~     Previous research has shown that people who have been hospitalised for pneumonia are more~     likely to die of conditions such as heart attacks, stroke and cancer in the weeks to months~     after their illness. This risk is linked to raised levels of inflammation. Laboratory~     research shows that vitamin D can help to clear inflammation. Vitamin D deficiency is very~     common in the United Kingdom. The investigators are conducting this study to find out if~     taking vitamin D can hasten long-term recovery from pneumonia by reducing inflammation.~   "
58383|NCT02802709|"~     This study evaluates a novel agent, SB-061, for the treatment of osteoarthritis of the knee.~     Half of the patients will receive the agent via intra-articular injection and half will~     receive a placebo injection.~   "
58384|NCT02802696|"~     This is a pilot double-blinded placebo-controlled randomized controlled trial (RCT) to~     evaluate the feasibility of conducting a multicenter, randomized, placebo-controlled trial to~     assess the efficacy of pre-transfusion furosemide in preventing transfusion-associated~     circulatory overload (TACO) in hemodynamically stable inpatients aged 65 years or older~     receiving a single unit red blood cell transfusion. Patients will be randomly allocated to~     receive either furosemide (20mg intravenous) or placebo (saline) within 60 minutes of~     starting a red blood cell (RBC) transfusion. Randomization will be stratified by centre and~     renal dysfunction (creatinine clearance ≥ 60 mL/min or < 60 mL/min). This is a blinded trial:~     patients, care-providers (physicians and nurses), data collectors, outcome adjudicators, and~     data analysts will not be aware of group allocation.~   "
58385|NCT02802683|"~     The purpose of this study is to compare the frequency of hypotension between hyperbaric~     anesthetics and isobaric anesthetics during cesarean section and determine whether continuous~     infusion of phenylephrine is effective in mothers who received hyperbaric anesthetics.~   "
58386|NCT02802670|"~     This is an open-label, non-randomized study to determine the excretion kinetics and mass~     balance of GDC-0810, and to determine metabolites present in blood, feces, and urine in~     healthy participants following a single 300-milligram (mg) oral dose of GDC-0810 containing~     approximately 100 microcuries of [14C] labeled GDC-0810 using conventional absorption,~     metabolism, and excretion (AME) methodology. The entire duration of the study is up to~     approximately 8 weeks.~   "
58387|NCT02802657|"~     The study will evaluate the efficacy and safety of two different regimens of Conbercept~     (Treat-and-Extend Regimen vs. PRN) in patients with wet AMD. This study is to provide~     long-term safety data in the treatment of patients with wet AMD.~   "
58388|NCT02802644|"~     This study evaluate the effect of dipeptidyl-peptidase 4 inhibitor on vascular healing after~     biodegradable polymer based sirolimus eluting stent implantation in diabetic pateints.~   "
58389|NCT02802631|"~     This is a Phase 1, randomized, double-blind, placebo-controlled, single and multiple~     ascending dose study of the safety, tolerability, and pharmacokinetics of Minocin®~     (minocycline) for injection in healthy adult subjects.~   "
58390|NCT02802618|"~     A new education material with 3D technique was developed, by integrating 3D technology in an~     existing evidence-based pulmonary educational program, to enable an increased personalized~     education within a group setting. The investigators believe that this educational model will~     lead to increased adherence to treatment, and suggested lifestyle changes, which in turn~     improves patients' HRQL~      The purpose of this study was therefore to develop a pulmonary educational program in~     interactive 3D visualization technology and to evaluate differences between education with 3D~     technique or conventional technique in patient with COPD.~      Furthermore the LCQ will be translated and culturally adapted into Swedish and tested for~     validity and reliability.~   "
58391|NCT02802605|"~     Prospectively evaluation of the incidence of thromboembolic events in hospitalized cirrhotic~     patients. 2. Efficacy and safety of use of bemiparin in preventing peripheral and portal~     thrombosis. 3. Monitoring antiXa levels.~   "
58392|NCT02802592|"~     EPOgen and Restrictive Transfusions in Patients Undergoing Cardiac Surgery (EPORT)~   "
69585|NCT02656147|"~     This study aims to evaluate the safety, efficacy and duration of response of CD19 Chimeric~     Antigen Receptor (CAR) redirected allogeneic γδT-cells in patients with high risk, relapsed~     CD19+ haematological malignancies.~   "
58393|NCT02802579|"~     Coronary arterial disease is a risk factor for bariatric surgery and might be a predictor for~     later major adverse coronary events. Diagnosis of coronary arterial disease would thus be~     desirable for obese patients, however percutaneous angiography is an invasive procedure and~     associated with a certain morbidity in obese patients. In this study the investigators would~     like to assess whether dual source CT angiography can be used for diagnosis of coronary~     arterial disease in severely obese patients and which settings yield the best image quality.~   "
58394|NCT02802566|"~     The purpose of this study is to devise and pilot a BMI-based prenatal vitamin for obese~     pregnant women. Currently, all pregnant women, regardless of body mass index, take the same~     prenatal vitamin. The investigators have found that obese pregnant women have higher levels~     of inflammation and oxidative stress, and a concomitant depletion of specific antioxidant~     micronutrients. The investigators have also found, in an animal model, that decreasing~     inflammation and oxidative stress during obese pregnancy was associated with improved~     offspring outcomes. Here the investigators aim to understand whether a BMI-based prenatal~     vitamin is effective in decreasing markers of inflammation and oxidative stress in~     pregnancies complicated by obesity.~   "
58395|NCT02802553|"~     This is a pilot study to test and characterize the ability of the SmartGoggles system to~     detect fluorescently labeled sentinel lymph nodes (SLNs). Specifically, this study will test~     the sensitivity and specificity of the SmartGoggles to detect indocyanine green (ICG)~     accumulation in sentinel lymph nodes of breast cancer patients after peritumoral injection of~     ICG (Cardio-GreenTM), under standard-of-care application conditions.~   "
58396|NCT02802540|"~     Anorexia is common symptom in cancer patients and is associated with increased morbidity and~     mortality. However timely detection with objective tools is necessary to establish the~     diagnosis of anorexia and to assess the magnitude of change over time. The anorexia~     pathophysiology is not clearly understood and treatment options are limited. Anecdotal~     historical benefits of smoking marijuana on nausea, pain and anorexia led to studies with~     marijuana and synthetic cannabinoids from Δ-9-tetrahydrocannabinol, the main active agent in~     marijuana. The endogenous cannabinoid system with its receptors CB1 and CB2 regulate appetite~     in four functional levels: (1) limbic system (hedonistic quality), (2) hypothalamus (appetite~     stimulant), (3) intestinal, and (4) tissue adipose.~      Nabilone, a synthetic analogue of THC approved in Mexico for nausea and vomiting induced by~     chemotherapy is also used in palliative care units for clinical improvement in increased~     appetite patients in terminal stages, however, there are no clinical trials demonstrating~     this benefit.~   "
58397|NCT02802527|"~     Percutaneous tracheostomy is routinely performed in most intensive care units in the~     world.Several studies have shown that the procedure is safe and economically efficient in~     comparison to open surgical operation in the operating room.~      In the investigator's institution as in a number of institutions in the country and abroad,~     it is acceptable to perform the operation either by withdrawing the endotracheal tube to a~     position near the vocal cords by direct laryngoscopy and then puncturing the trachea with a~     needle distal to the endotracheal tube, prior to carrying out the PDT, by location of the~     anatomy by palpation of the neck, or alternatively by doing the entire procedure under~     bronchoscopic guidance.~      So far, no systematic comparison has been made between the two methods ie PDT without~     bronchoscopy versus PDT with bronchoscopy.~   "
58398|NCT02802514|"~     The drug effects will be studied after a single dose of 50 milligram (mg) albiglutide and a~     single dose of 10 microgram exenatide, to gain insight into the central mechanisms of nausea~     associated with Glucagon-like peptide-1 receptor (GLP-1R) agonists. This study will explore~     the potential differences at the expected time of maximum concentration (Cmax) between a~     long-acting (albiglutide) and short-acting (exenatide) GLP-1R agonist in brain activation of~     healthy volunteers assessed by magnetic resonance imaging (MRI). This is a phase IV, 2-part,~     2-period crossover (session), single dose, randomized, single blind (blinded to both the~     subject and the imaging evaluators analysing the MRI data), placebo- and active-controlled~     study in adult healthy volunteers who are susceptible to motion sickness. Part A and Part B~     are the same in design, both consisting of a screening stage, a dosing/assessment stage, and~     a follow-up visit. Data from Part A will inform progression, methods, and analysis plan for~     Part B. Each sequence includes three scanning visits: albiglutide plus scan, exenatide plus~     scan and an off-therapy -natural history scan with a 6-9 week washout period between the~     dosing scans. A total of 24 to 28 subjects will be randomized in the study (Part A and Part~     B). The cross over design is divided into 2 sessions and schedule is as follow, on Day 1~     (either Session 1 (S1) or Session 2 (S2) per, if randomized) subject will under go an~     off-therapy MRI scan, on Day 5 subject will receive a single dose of 50 mg albiglutide or~     albiglutide placebo, and Day 8 subject will receive a single dose of 10 microgram exenatide~     or saline placebo followed by a post-dose MRI scan. At each session subject will receive only~     one active drug (albiglutide or exenatide).~   "
58399|NCT02802501|"~     Tafenoquine (TQ) is an 8-aminoquinoline anti-malarial drug which is in development as a~     single-dose treatment for the radical cure of P.vivax malaria when given with standard doses~     of chloroquine. Currently, the only available drug for radical cure is primaquine (PQ) which~     requires administration over 14 days, resulting in poor compliance. In Indonesia, chloroquine~     has been replaced by artemisinin-based combination therapy (i.e. ACTs) due to widespread~     chloroquine resistance. This study will evaluate the efficacy and safety of a single dose of~     tafenoquine when co-administered with an ACT (i.e. DHA-PQP). This single-center,~     double-blind, double-dummy, randomized study will test the superiority of DHA-PQP plus TQ~     against DHA-PQP alone in the prevention of P. vivax malaria relapse at 6 months. The study~     will be conducted in male Indonesian soldiers diagnosed with P.vivax malaria on return from~     deployment to a malarious region of Indonesia. A PQ plus DHA-PQP comparator arm is included~     to provide an informal comparison against the standard 14 day treatment for P.vivax malaria~     in Indonesia. Subjects who are glucose-6-phosphate dehydrogenase deficient (G6PD deficient)~     will be excluded due to the risk of acute hemolysis following dosing with 8-aminoquinolines~     drugs. Subjects who have a recurrence of P.vivax malaria during the study will be treated~     with an ACT plus PQ (0.5mg/kg for 14 days), in line with local treatment guidelines. At the~     end of the 6 month follow up period, any subject who has not relapsed will be given open~     label PQ (0.5mg/kg daily for 14 days) to minimize the likelihood of relapse after the study.~     Approximately 200 subjects will be screened to achieve 150 randomized subjects. The total~     duration of study for each subject will be 180-195 days. This study is being carried out to~     support registration of TQ in Indonesia and other countries where ACTs are first line~     therapy.~   "
58437|NCT02802007|"~     This is a prospective, non-randomized, open trial to be conducted in overweight and obese~     individuals. The primary objective is to evaluate the safety of the Elipse™ Intragastric~     Balloon System for the treatment of overweight and obese individuals. The secondary objective~     is to collect efficacy and device performance information to assist with future trial design~     and device iterations.~   "
58400|NCT02802488|"~     Patients with atrial fibrillation are at increased risk of thrombus formation in the left~     heart, especially in the auricula and the atrium. Their presence increases the risk of~     ischemic stroke, especially during cardioversion, performed either by drug or by external~     electric shock. The gold standard to exclude this thrombus and consider cardioversion is the~     transesophageal echocardiography.~      D-dimers, products of the degradation of fibrin, have been studied several times to assess~     the presence of thrombi in the body, especially in pulmonary embolism. In cardiology and~     despite several studies on the matter, there is currently no blood D-dimers value allowing to~     detect the presence of a thrombus with a good predictive value. Correlating the D-dimer~     values with age, as has been done for some years in pulmonary embolism, would give the~     opportunity to create a simple, inexpensive and widely applicable tool to eliminate the~     presence of a thrombus in the left heart.~      If the results are satisfactory, the investigators might consider not using transesophageal~     echocardiography as this examination is unpleasant for the patient and operator dependant,~     unlike a standard blood sampling.~      This study aims to test the following hypothesis: D-dimers values superior or equal to ten~     times the patient's age is predictive of a thrombus.~   "
58401|NCT02802475|"~     The Antibodies Causing Epilepsy Syndromes (ACES) Study is a observational cohort study~     focusing on detection of auto-immune epilepsy in patients with epilepsy of unknown origin.~   "
58402|NCT02802462|"~     Exercise training improves endothelium-dependent vasodilation, whereas hypoxic stress causes~     vascular endothelial dysfunction. Monocyte- derived endothelial progenitor cells (Mon-EPCs)~     contribute to vascular repair process by differentiating into endothelial cells. This study~     investigates how high-intensity interval (HIT) and moderate intensity-continuous (MCT)~     exercise training affect circulating Mon-EPC levels and EPC functionality under hypoxic~     condition. Sixty healthy sedentary males were randomized to engage either HIT (3-minute~     intervals at 40% and 80%VO2max , n=20) or MCT (sustained 60%VO2max , n=20) for 30~     minutes/day, 5 days/week for 6 weeks, or to a control group that did not received exercise~     intervention (n=20). Mon-EPC characteristics and EPC functionality under hypoxic exercise~     (HE, 100W under 12%O 2 ) were determined before and after various interventions.~   "
58403|NCT02802449|"~     Three hundred thirty (330) overweight, pre-hypertensive/controlled hypertensive,~     African-American participants will be enrolled in a 8 week study to assess the effect of two~     administrations of Vitamin D3 on Vitamin D serum responsiveness as a function of clinical,~     biologic and genetic factors. The investigators anticipate that at least 300 participants~     will complete this study.~      Written, signed and dated informed consent to participate in the study will be given by the~     participant or a legally acceptable representative, in accordance with the International~     Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guideline E6 and applicable~     regulations, before completing any study-related activities/procedures. The original signed~     and dated consent will be kept in the subject's research file and a copy given to the~     subject. A copy will also be placed in their medical record.~   "
58404|NCT02802436|"~     The advent of endosseous implant restoration has driven an increasing need for alveolar bone~     preservation and/or augmentation strategies. Investigations have explored the physical~     scaffold effects of a wide variety of bone graft materials with each graft material offering~     a more or less attractive surface for bone deposition. The seeding of these scaffolds with~     biologically active material seeks to enhance the osteoconductive effect by influencing the~     temporal or sequential steps which result in the desired end product-new bone.~      Alveolar socket grafts are a common example of these preservation techniques. They are an~     accepted procedure to maximize the retention of alveolar bone post extraction. They appear to~     act as a passive scaffold for clot retention and subsequent bone regeneration.~      The current pilot research project explores addition of a known Bioactive Agent: Platelet~     Derived Growth Factor (PDGF) to test its impact on healing responses. Histomorphometric~     assessments will be utilized on microscopic slide material derived from cores trephined as~     the initial step in the preparation for placement of endosseous dental implants. Outcomes~     measured will include:~      Clinical observation of healing response~      Microscopic measures will be~        -  Measures of residual graft material~        -  New bone formation and new bone contact area with graft~        -  Measures of vascular content~        -  Osteoclast count~        -  Qualitative measures of other marrow components (Cells and relative fiber/ fat content,~          liner cell characteristics.)~   "
58405|NCT02802423|"~     The primary purpose of this study is to determine the safety and recommended dose level (RDL)~     of BLEX 404 Oral Liquid combined with Docetaxel monotherapy in a 21-day schedule. The~     secondary purpose is to assess the efficacy and safety of BLEX 404 Oral Liquid combined with~     Docetaxel monotherapy.~   "
58406|NCT02802410|"~     This study aims to evaluate the effects of IQ-Tape, Kinesiotaping and no Taping on muscle~     activity during daily activity and sport activity.~   "
58407|NCT02802397|"~     Early ovarian reserve decreased is one of the main causes of infertility for women after 35~     years. The relationship between this decreased and exposure to chemicals, including~     persistent endocrine disruptors or organic solvents, has been little studied. However,~     several in vivo or in vitro experimental studies suggested that these chemicals may impaired~     ovarian function.~      The main objective is to study the relationship between early ovarian reserve decreased and~     exposure to persistent organic pollutants.~      The secondary objectives are to study the relationship between early ovarian reserve~     decreased and exposure to organic solvents and heavy metals.~      Multicenter case-control study. This project will permit to increase the knowledge concerning~     the etiology of early decreased ovarian reserve. Considering that exposure of interest are~     frequent, the results may be important in a public health perspective. If associations are~     observed in this study, the results may encouraged prevention strategy.~   "
58408|NCT02802384|"~     Paget's disease of the bone is a skeletal disorder which results in increased and~     disorganized bone remodeling, leading to dense but fragile and expanding bones. The~     identified genetic causes of Paget's disease of bone only explain why bone is destroyed, but~     not why the bone formed in its place is abnormal.~      Current treatment for people with Paget's disease of the bone is limited to patients with~     bone pain, thought to be related to high rate of bone turnover (breakdown and rebuilding of~     bone) and works by slowing down the rate of bone breakdown. The current treatment does not~     address the excess blood vessels and bone formed.~      This research is being done to understand factors that may promote blood vessel and bone~     formation in Paget's disease of the bone.~   "
58409|NCT02802371|"~     Caring for patients with Alzheimer Disease or Related Disorders (ADRD) is accompanied with a~     caregiver burden that increases with the progression of the disease. This burden can have~     physical, psychological, emotional, social and financial issue on the informal caregivers who~     are often represented as hidden secondary patients. They frequently have a higher risk of~     developing mood disorders as depression, anxiety, stress, sleep disorders and a lower quality~     of life associated with a greater use of psychotropic drugs. They also incur higher risk of~     heart disease and mortality. The embrittlement of the caregiver is a major factor of early~     institutionalization of patient. In the PIXEL study, the mean age of the men caregivers was~     73.9 years and 64.8 for the women caregivers. Elderly themselves, especially spouses, the~     informal caregivers are also exposed to common chronic diseases and associated polypharmacy~     with a higher risk of developing drug-related problems due to aging and negligence of their~     own health care. These risks are increased mainly in the elderly because of changes in~     pharmacokinetic and pharmacodynamic parameters related to aging, acute or chronic diseases~     and the potentially inappropriate prescription (PIP). Previous studies have shown the~     effectiveness and positive impact of optimization of the therapeutics by a clinical~     pharmacist on the reduction of drug-related problems, length of hospital stay, readmission~     rates, quality of life and mortality. The patient's medication management is usually~     delegated to the informal caregiver, who must also manage his own treatment. The caregiver~     may face difficulties with therapeutics (e.g., inappropriate dosage form, adverse effects and~     patient refusal) that could impact on its compliance with treatment or that of his relative.~     No previous study has evaluated the impact of pharmaceutical collaborative care including~     personalized interview with a clinical pharmacist and optimization of drug prescribing among~     patients with ADRD and their caregivers.~      However, many studies have assessed the effectiveness of non-pharmacological interventions on~     caregiver burden, mood disorders and the patient institutionalization. Meta-analysis showed a~     moderate improvement of the caregiver burden.~      The main objective of the PHARMAID study is to measure the impact of personalized~     pharmaceutical collaborative care integrated to a multidisciplinary psychosocial program on~     the burden of ADRD caregivers and assessed at 18-month follow-up.~   "
58410|NCT02802358|"~     Objectives: To describe social and health care provided to our older patients who have been~     admitted in the emergency department (ED) after suffering from a hip or wrist fracture due to~     a fall. To compare among the different hospitals and town halls, the health and social care~     that participants received. To compare the functional dependency and health related quality~     of life (HRQoL) presented by the patients immediately and six months after a fall.~      Methodology: Prospective Cohort study. One hundred and fifty patients suffering from each~     type of fracture (hip or wrist) will be recruited consecutively in the Basque Health System's~     participant hospitals sub-project. Within 3 sub-projects, more than 3000 cases are expected~     to be collected. Data will be collected from ED and hospital clinical records and by means of~     questionnaires to measure functional dependency (Barthel and Lawton indexes) and HRQoL~     (SF-36) requesting information on status before the fall, immediately and six months later.~     In addition to this, data referred to care provided to the patients by traumatologist,~     rehabilitation or primary care provider as well as social services in their homes after the~     index episode will be collected.~   "
58411|NCT02802345|"~     To assess efficacy and safety of concomitant treatment with nintedanib and sildenafil in~     Idiopathic Pulmonary Fibrosis (IPF) patients with advanced lung function impairment.~   "
58412|NCT02802332|"~     This study will evaluate whether or not provision of a simple card (footlength card) that~     allows identification of low birth weight and/or preterm babies through measurement of the~     length of a baby's foot, can improve basic newborn care behaviors in rural Nepal.~   "
58413|NCT02802319|"~     The study is a two-arm, parallel-design, randomized, prospective clinical trial designed to~     examine histologic wound healing following ridge preservation using bovine xenograft and~     porcine xenograft materials.This protocol involves procedures that are standard care. All~     materials are FDA-approved materials being used in an FDA-approved manner. The test group~     subjects will have extraction sockets grafted with porcine xenograft (Zcore). This test group~     will be compared to an active control group using bovine xenograft (Bio-Oss). The null~     hypothesis is that there will be no significant difference in formation of new vital bone~     between treatment groups (primary outcome).~      Each subjects will have a non-molar tooth extracted and the socket grafted with either test~     or control graft material. At the time of dental implant placement 18-20 weeks after tooth~     extraction a small core biopsy specimen will be removed from the implant site. The core~     biopsy will then be evaluated for the primary histologic outcome of % vital bone formation~     and secondary histologic outcome of % residual graft material.~   "
58414|NCT02802306|"~     This is an Outside the United States, post-CE Mark, multi-center, single-arm, non-blinded~     study designed to investigate the safety and efficacy of the Tack Endovascular System. This~     study will evaluate subjects with PAD who receive PTA (with a drug-coated balloon (DCB)) in~     the SFA and in popliteal arteries, ranging in diameter from 2.5mm to 6.0mm and lesion lengths~     of ≥20mm and ≤150mm, and have a resulting dissection(s) type(s) A through F. TOBA III will~     also evaluate the safety and efficacy of the device when used to treat a sub-group presenting~     with longer lesions of >150mm and ≤250mm.~   "
58415|NCT02802293|"~     The purpose of this study is to determine the clinical effects (if any) of~     connectivity-guided repetitive transcranial magnetic stimulation (rTMS) in the treatment of~     major depressive disorder (MDD) to provide clues about the ideal neural networks to target~     for more robust clinical outcomes, and to identify potential biomarkers of treatment response~     including changes in brain network connectivity.~   "
58416|NCT02802280|"~     Hypothesis: In addition to the liver deleterious effects, Chronic Hepatitis C (CHC) can cause~     changes in other organs highlighting the increased cardiovascular risk (CVR) through~     accelerated atherosclerosis, whose consequences may persist even after healing infection with~     new antiviral treatments. This can have major impact on the health system. Obtaining a~     Sustained Virological Response (SVR) with a free Interferon (IFN) antiviral treatment is~     probably able to reverse, at least partially, increased vascular risk induced by Hepatitis C~     virus (HCV) and perhaps ultimately reverse the subclinical atherosclerosis.~      Aims: To study the presence of early-subclinical atherosclerotic disease (endothelial~     dysfunction and subclinical atherosclerosis) in patients with CHC and evaluate the influence~     of treatment in the short and medium term on the CVR derived. Studying these same issues but~     in patients with established atherosclerotic disease.~   "
58417|NCT02802267|"~     Evaluate the effect of the addition of inecalcitol to decitabine treatment on overall~     survival in previously untreated AML patients aged 65 years or more who are randomly assigned~     to receive decitabine with or without inecalcitol.~   "
58418|NCT02802254|"~     The aim of this study is to evaluate the efficiency of a minimal intervention on risk~     perception of physical inactivity in patients with known coronary heart disease (CHD) and~     patients at risk for CHD. Therefore half of the patients (intervention group) get a personal~     feedback on their individual level of physical activity measured by pedometers and~     self-report questionnaires plus information about the risk factor 'physical inactivity' for~     heart diseases. Following the hypotheses the feedback should increase the patients risk~     perception of physical inactivity and furthermore increase physical activity.~   "
58422|NCT02802202|"~     To date, there are no valid and reliable pressure pain threshold scales for use in research~     or clinical practice. The existing manual palpation protocols and scales have limited support~     in the literature and our knowledge has not advanced since these scales were proposed in the~     1990's. Therefore, the purpose of this investigation was to develop a valid and reliable PPTS~     in order to provide an objective means of assessing pressure pain thresholds and create a~     reliable method of communication among clinicians for individuals with a diagnoses~     characterized by MPS and FM. These conditions were chosen based on their high prevalence~     among chronic pain conditions and are also dependent upon the manual palpation examination~     for their diagnosis.~   "
58423|NCT02802189|"~     The purpose of this study is to examine the combine effect of the integrated neuromuscular~     inhibition technique (soft tissue mobilization techniques protocol), in combination with the~     therapeutic exercise in patients with chronic mechanical neck pain in the sub-acute stage of~     symptoms, and to determine whether this combination substantially helps the faster and more~     efficient installation of adaptations of exercising.~   "
58424|NCT02802176|"~     The purpose of this study is to evaluate implantation rate with intra-vaginal culture with~     the INVOcell device versus traditional IVF while using minimal stimulation protocols~   "
58425|NCT02802163|"~     The purpose of this study for Phase l is to determine the maximum tolerated dose of~     panobinostat given in combination with carfilzomib, lenalidomide, and dexamethasone in 28-day~     cycles as induction (initial) therapy to participants with newly diagnosed multiple myeloma.~      In Phase ll, investigators will evaluate the safety (side effects) and efficacy~     (effectiveness) of panobinostat in combination with carfilzomib, lenalidomide, and~     dexamethasone.~   "
58426|NCT02802150|"~     The purpose of this study is to evaluate the clinical efficacy and safety of 10-weeks oral~     consumption of Zanthoxylum schinifolium seed Oil (ZSO) in patients with mild dry eye disease.~   "
58427|NCT02802137|"~     The study investigated the 24-hour efficacy and ocular surface health with preservative-free~     tafluprost and a combined preservative-free regimen (tafluprost and dorzolamide/timolol fixed~     combination) in open-angle glaucoma patients insufficiently controlled on latanoprost~     monotherapy and showing signs, or symptoms of ocular surface disease with~     preservative-containing latanoprost monotherapy. This trial randomized open-angle glaucoma~     patients insufficiently controlled (IOP > 20 mm Hg) on branded, or generic latanoprost~     monotherapy who required further IOP reduction and who demonstrated clinical signs, or~     symptoms of ocular surface disease.~   "
58428|NCT02802124|"~     The aim of this research project is to assess the feasibility and safety of carbon-ion~     radiotherapy for the treatment of localized Chinese hepatocellular carcinoma~   "
58429|NCT02802111|"~     Albuterol is the most commonly used β agonist to treat reversible lower airway obstruction.~     Albuterol contains a racemic mixture of two enantiomers. Levalbuterol contains the single R~     form enantiomer. Levalbuterol is frequently prescribed to limit cardiovascular toxicity. The~     investigators sought to examine the changes in oxygen consumption (V'O2) and Heart Rate (HR)~     following administration of albuterol and~   "
58430|NCT02802098|"~     This is a single-arm pilot proof of concept, open-label clinical trial. Twenty-five subjects~     will be enrolled in 6 sites.~      Metastatic breast cancer patients with disease progression to bevacizumab-alone maintenance~     treatment will be potential candidates.~      Bevacizumab maintenance will be considered as six weeks of bevacizumab treatment in~     monotherapy after the last dose of chemotherapy in the context of bevacizumab plus~     chemotherapy first-line regimens.~      When progression to bevacizumab-alone maintenance treatment occurs, patients will enter the~     trial and will start receiving DURVALUMAB 750 mg (equivalent to 10 mg/kg Q2W) IV infusion, if~     ≥ 30 kg, every 2 weeks together with bevacizumab 15mg/kg IV infusion every 3 weeks. The~     patients will undergo a tumor biopsy before the first dose of DURVALUMAB, and after one month~     of combined treatment - the blood sampling will continue on a monthly basis. The treatment~     will continue until disease progression or for a maximum of 50 weeks.~   "
58431|NCT02802085|"~     Voluntary Post-Marketing Clinical Follow-up (PMCF) as part of the post marketing surveillance~     plan for the product under investigation.~      For this PMCF only CE-marked medical devices have been used and will be used within their~     intended purpose and no additional invasive or other stressful examinations have been or are~     to be carried out (acc. to MPG §23b).~   "
58432|NCT02802072|"~     To investigate the long-term effects of intracranial implantation of Enterprise stent system~     versus antiplatelet medication on neurologic deficits, daily living abilities, and carotid~     artery stenosis in patients with atherosclerotic ischemic stroke.~   "
58433|NCT02802059|"~     This study evaluates the long term effects of E. coli strain Nissle 1917 (EcN-Suspension)~     probiotic bacteria administration on the number of both, bacterial and viral infections~     during the first 24 months of infant's life. Half of study participants will receive~     EcN-Suspension, while the other half will receive placebo. In an additional non-clinical~     explorative evaluation will furthermore be investigated whether the early intestinal~     colonization with E.coli strain Nissle 1917 affects the establishment of the intestinal~     microbiota.~   "
58434|NCT02802046|"~     Angina pectoris is the most common clinical manifestation of coronary heart disease（CHD）,~     which is the main feature of chest pain caused by transient myocardial ischemia. Chronic~     stable angina pectoris is the degree, frequency, nature and cause of angina pectoris in~     patients with no significant change in a few weeks. The disease incidence is complex,~     difficult to diagnosis and treatment, clinical should be combined with various inspection~     methods for diagnosis and differential diagnosis. Fractional flow reserve of computerized~     tomographic scanning (FFRCT ) allows computerized tomographic scanning（CT） to scan the~     determination of coronary blood flow and blood pressure in the heart at rest and hyperemia,~     but no need to additional check or drugs. This technique has been used for noninvasive~     fractional flow reserve (FFR) in the calculation, assuming normal artery, calculated by the~     ratio of the maximum blood flow and blood flow of coronary artery stenosis of an artery.~     Along with the development and progress of computational fluid dynamics, in the resting state~     by computed tomographic angiography of coronary artery(CCTA) image data based, simulation of~     coronary artery maximal hyperemia and according to the 3-dimensional model of the traditional~     method of reconstruction of coronary arterial tree and ventricular muscle structure, and in~     order to calculated coronary blood flow and pressure. FFRCT is a novel non-invasive~     examination method, using computed tomographic angiography of coronary artery image data can~     be calculated FFR, and preliminary study proved that it has a high degree of correlation with~     traumatic FFR. Therefore, this study aims to evaluate the correlation between the degree of~     coronary stenosis and the grading of angina pectoris by noninvasive means --FFRCT, in order~     to provide a new idea for the diagnosis and differential diagnosis of coronary heart disease.~   "
58435|NCT02802033|"~     Details regarding the degenerative spine disorders will be collected with a specific focus on~     the use of osteobiologics in treating degenerative conditions and their impact on fusion, as~     well as patient-reported outcomes for these conditions.~   "
58438|NCT02801994|"~     Rational. The mismatch between the activity of the respiratory muscles and the assistance~     delivered by the ventilator results in patient-ventilator disharmony, which is commonly~     observed in ICU patients and is associated with dyspnea and patient-ventilator asynchrony.~     Both dyspnea and asynchrony are in turn associated with a worse prognosis. Unlike~     conventional modes of mechanical ventilation, such as pressure support ventilation (PSV) that~     deliver a constant level of assistance regardless of the patient effort, Proportional~     Assisted Ventilation (PAV) adjusts the level of ventilator assistance to the activity of~     respiratory muscles. To date, data on the impact of PAV on dyspnea and patient ventilator~     asynchrony are scarce and most studies have been conducted in healthy subjects or in ICU~     patients who had no severe dyspnea nor severe asynchrony. To our knowledge, there are no data~     in patients with severe patient-ventilator dysharmony.~      Study Aim. To evaluate the impact of PAV on dyspnea and patient-ventilator asynchrony in ICU~     mechanically ventilated patients in intensive care with severe patient-ventilator disharmony~     defined as either severe dyspnea or severe patient-ventilator asynchrony.~      Patients and Methods. Will be included 24 ICU mechanically ventilated patient exhibiting~     severe patient-ventilator dysharmony with PSV. The intensity of dyspnea will be assessed by~     the VAS, the ICRDOSS and by the electromyogram of extradiaphragmatic inspiratory muscles and~     pre inspiratory potential collected from the electroencephalogram. The prevalence of~     patient-ventilator asynchrony will be quantified.~      Expected results. It is anticipated that the switch from PSV to PAV will decrease the~     prevalence and severity of dyspnea and the prevalence of patient-ventilator asynchrony.~   "
58439|NCT02801981|"~     This study will be the first to evaluate the safety, tolerability, pharmacokinetics and~     pharmacodynamics following single dose of 10 milligrams (mg) to 180 mg of GSK2330672 in~     Japanese healthy subjects. This is a double-blind, randomized, placebo-controlled,~     dose-escalating and incomplete block crossover study to be conducted in 16 Japanese healthy~     subjects. Study will be conducted in four periods; subjects will receive either placebo or~     GSK2330672 (10 mg, 30 mg, 90 mg or 180 mg based on randomization) in each treatment period.~     Each period will be separated by washout period (at least 6 days from dosing). Total duration~     of study for each subject will be approximately 5 weeks from the first dosing to follow up~     visit.~   "
58440|NCT02801968|"~     The purpose of this study is to determine the efficacy of Tap block after cesarean delivery~     as a component of multimodal analgesia and evaluation of postoperative drugs consumption.~   "
58441|NCT02801955|"~     For preoperative staging and prediction of peritoneal dissemination of gastric~     adenocarcinoma, usage of serum and peritoneal levels of carcinoembryonic antigen (CEA) and CA~     19-9 may be helpful. Additionally, the prognosis of the patients with gastric adenocarcinoma~     treated with gastrectrectomy may be associated with serum and peritoneal levels of tumor~     markers.~   "
58442|NCT02801942|"~     It is hypothesized that early changes in the immune system in New Onset Type 1 Diabetes~     Mellitus (NOT1D) subjects can be detected in immune cells from the inguinal lymph nodes~     (iLN), which will be distinct from changes observed in peripheral blood derived immune cells.~     Therefore this study will assess and compare the molecular immune profile of cells derived~     from the iLN in healthy and NOT1D subjects, to understand the immunological processes that~     may lead to beta cell destruction. It is a multi-center, non-drug treatment study. Up to 15~     subjects in each group, namely healthy subjects and NOT1D subjects, will be evaluated in the~     study. A data look will be carried out after the recruitment of a cohort of up to 5 healthy~     subjects, to determine if the quality and quantity of cells derived from aspirate or core~     biopsy or from peripheral blood are likely to be sufficient to continue the study to meet its~     primary objective. An interim analysis will be carried out after the recruitment of 5~     evaluable healthy subjects and 5 evaluable NOT1D subjects. The primary purpose of this~     interim analysis will be to facilitate decision making and study design for a potential~     follow-up interventional study.~   "
58443|NCT02801929|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
58444|NCT02801916|"~     Viscous dietary fibers including oat β-glucan are one of the most effective classes of~     functional food ingredients for reducing postprandial blood glucose. The mechanism of action~     is thought to be via an increase in viscosity of the stomach contents that delays gastric~     emptying and reduces mixing of food with digestive enzymes, which, in turn, retards glucose~     absorption. Previous studies suggest that taking viscous fibers separate from a meal may not~     be effective in reducing postprandial glycemia. The purpose of this study is to re-assess the~     effect of consuming a preload of a commercially available oat-bran (4.5, 13.6 or 27.3 g)~     containing 22% of high molecular weight oat β-glucan (O22) mixed in water before a test-meal~     of white bread on glycemic responses in 10 healthy humans.~   "
58445|NCT02801903|"~     This is a 21 day, single-center, open-label pharmacokinetic, safety and tolerability study in~     adolescents with moderate to severe acne vulgaris.~   "
58446|NCT02801890|"~     Peritoneal fibrosis may be occurred as a serious complication of peritoneal dialysis. It's~     the main factor of UFF that could lead to the Encapsulating Peritoneal Sclerosis (EPS). Using~     the potential features of MSCs in the treatment of fibrosis may offer new insights into~     reconstruction the damaged tissues. The project intends to transplant autologous MSCs to ten~     peritoneal dialysis patients with ultra-filtration failure. It's going to study infusion~     effects in clinical, cellular and molecular levels.~      So in this trial, we will evaluate the effects of this intervention after intravenous~     injection of autologous adipose derived mesenchymal stem cells in 10 peritoneal dialysis~     patients with ultra filtration failure (UFF). Fifteen UFF patients are also considered as the~     control group. Then they will be followed 20, 45 and 90 days, and also 4 and 6 months after~     first injection.~   "
58447|NCT02801877|"~     This study will evaluate and compare a smartphone intervention for depression and anxiety~     that uses machine learning to tailor treatment for participants with the same intervention~     without the machine learning component. The intervention, referred to as IntelliCare,~     delivers participant-specific treatment material and motivational messaging via a mobile~     phone to help individuals with depression and/or anxiety. Information and data received from~     the participant will inform the tailored treatment approach through machine learning. The~     purpose of this study is to compare different versions of the main IntelliCare Hub App (the~     centralized program delivery system) and participant user experience whether with the support~     of a coach or used independently. The RCT aims to obtain information on the feasibility and~     effectiveness of IntelliCare in improving symptoms of depression and anxiety.~   "
58449|NCT02801851|"~     This study will refine and pilot test an innovative, emergency department (ED)-based~     intervention for delirium screening, initial management, and communication with inpatient~     providers, and examine the impact of this intervention on the rate of documentation of~     delirium in the electronic health record by ED and inpatient providers. To achieve this, the~     study will develop and pilot test an intervention, Delirium Screening (SCREEN-ED) in the ED,~     involving 300 older patients (150 newly enrolled intervention participants, 150 historical~     controls (comparison group) currently being collected), that has 4 key components: systematic~     screening for delirium using the Confusion Assessment Method (CAM), informing providers of~     the screening result, a checklist protocol for initial delirium management based on clinical~     guidelines, and documentation in the Electronic Health Record (EHR) and communication with~     inpatient providers of delirium screening results.~      The study has two primary aims. The first is to refine and test the feasibility and~     acceptability of the SCREEN-ED intervention. The second is to examine the impact of SCREEN-ED~     on rate of delirium documentation and secondary outcomes (length of hospital stay, repeat ED~     visits and hospitalizations and mortality over 6-months) in the 150 newly enrolled~     intervention group compared with 150 already collected historical controls.~   "
58450|NCT02801838|"~     Background : Dyspnea is common and severely impact mechanically ventilated patients outcomes~     in intensive care unit (ICU). Recognize, measure and treat dyspnea have become current major~     therapeutic challenge. Its measurement involves a self-assessment by the patient, and by~     definition, a certain level of communication. Consequently, a large proportion of the~     ICU-population (non-communicating) misses its evaluation and potential benefits associated~     with its control. In other hand, electrophysiological markers that help to detect and~     quantify dyspnea regardless of the patient's cooperation, has been developed and validated as~     dyspnea surrogate, namely: 1) the electromyographic (EMG) activity of extra diaphragmatic~     inspiratory muscles and 2) the premotor inspiratory potentials (PIP) detected on the~     electroencephalogram (EEG). Because of its complex implementation in daily practice the~     research team has developed alternatively a behavioral score called IC-RDOS that provides~     reliable dyspnea assessment also without patient participation. Validated in conscious~     patients, it has not been yet validated in non-communicating patients.~      Hypothesis : The IC-RDOS is valid for non-communicating ventilated patients and allows a~     simple and reliable assessment of dyspnea in this specific population.~      Objective : To validate the IC-RDOS in non-communicating ICU patients under mechanical~     ventilation, using comparison with the tools validated for reliable measure of dyspnea in~     non-communicating patients (EMG, EEG).~      Patients and Methods: In 40 patients will be collected simultaneously IC-RDOS, PIP (EEG) and~     electromyographic activity of three extra diaphragmatic inspiratory muscles (scalene,~     parasternal and Alae nasi) before and after intervention therapy aiming at reduce dyspnea~     (ventilator settings or pharmacological intervention), initiated by the clinician in charge~     of the patient.~      Expected results : Observe a strong positive correlation between the IC-RDOS and~     electrophysiological markers (amplitude of the electromyogram and presence and magnitude of~     PIP). Observe a correlation between changes in the IC-RDOS and the electrophysiological~     markers after therapeutic interventions.~      Optimizing patient comfort is a prominent concern in the ICU. By optimizing the detection and~     quantification of dyspnea in non-communicating patients, this study should ultimately improve~     the management and the better living of ventilated patients in intensive care~   "
58451|NCT02801825|"~     The main purpose of the study is to compare two ultrasound-guided arterial cannulation~     procedures: in-plane infraclavicular axillary artery cannulation and out-of-plane femoral~     artery cannulation.~   "
58452|NCT02801812|"~     The purpose of this study is to investigate the role of nailfold capillaroscopy in the~     assessment of patients with Systemic Lupus Erythematosus (SLE).~      Primary endpoint:~      - To compare the frequency of major capillaroscopic abnormalities in patients with SLE and~     healthy controls.~      Secondary endpoints:~        -  To compare the frequency of major capillaroscopic abnormalities in patients with active~          and non-active SLE / active SLE and healthy controls / non-active SLE and healthy~          controls.~        -  To study the association of different capillaroscopic parameters and the status of~          subjects (SLE / active SLE / non-active SLE / healthy controls).~   "
58453|NCT02801799|"~     This trial is a part of the project: 'A novel technique for reliable, precise and safe~     postoperative pain management' (project no. 65-2014-3).~      The purpose of the trial is to investigate the effects of changing peri-neural infusion rates~     of ropivacaine 0.2% on the duration of nerve block.~      Intervention:~      Two intervention-days. Each day a peri-neural infusion of a fixed volume of ropivacaine 0.2%~     is to be infused in one of five infusion rates, using a peri-neural catheter.~      Intervention day 1: Focus on the common peroneal nerve. Intervention day 2: Focus on the~     sciatic nerve.~   "
58454|NCT02801786|"~     This is a double-blind placebo-controlled randomized clinical trial to test the use of~     tamoxifen or lidocaine for diminishing the pain and discomfort while performing mammography,~     intending to include 450 patients distributed between the three groups.~   "
58455|NCT02801773|"~     The aim of this randomized placebo- controlled clinical trials is to evaluate the effects of~     Lactobacillus reuteri containing probiotic lozenges as an adjunct to scaling and root~     planning (SRP). Material and methods: Thirty six gingivitis patients will be recruited and~     monitored clinically at baseline, 3 and 6 month after therapy. All patients will receive~     scaling and periodontal treatment and randomly will be assigned over an experimental (SRP +~     probiotic, N=18) or control (SRP+ placebo, n=18) group. The lozenges will be used once per~     day during 3 month.~   "
58456|NCT02801760|"~     This study involves a one-time, web-based quantitative structured self-complete (web-based)~     survey for all subjects and a qualitative semi-structured (qualitative) interview for a~     selected sub-sample of subjects to evaluate the consent processes in association with~     research outcomes, specifically early adherence to Pre-exposure Prophylaxis (PrEP) and Human~     Immunodeficiency Virus (HIV) seroconversion at any point during participation in the ATN 110~     or ATN 113 study.~   "
58457|NCT02801747|"~     The present study targets the large population of persons living with HIV/AIDS (PLHA) in the~     U.S. who are both insufficiently engaged in HIV primary care and not taking antiretroviral~     therapy (ART), who are mainly African American/Black and Latino. NIH has emphasized the~     urgent need for new research approaches to advance intervention science, and the proposed~     project employs a new, potent, and innovative research methodology, the Multiphase~     Optimization STrategy (MOST), a framework for developing highly efficacious, efficient,~     scalable, and cost-effective interventions. The proposed study has the highest public health~     significance: it addresses a vulnerable population of PLHA, including the critically~     important subpopulations of men who have sex with men (MSM) and substance users; will develop~     an efficient and cost effective intervention to increase engagement along the HIV care~     continuum for these vulnerable groups; and addresses two areas highlighted in the August 2015~     notice on research priorities from the NIH Office of AIDS Research (NOT-OD-15-137), namely,~     engaging PLHA in prevention/treatment services, and reducing HIV/AIDS-related racial/ethnic~     disparities.~   "
58849|NCT02796586|"~     To evaluate the feasibility and effectiveness of group contraceptive counseling on family~     planning knowledge acquisition, service satisfaction, method uptake and continuation among a~     group of resettled African refugee women.~   "
58458|NCT02801734|"~     i. Project Background Patients with advanced lung cancer have a high symptom burden and low~     quality of life. Early palliative care improves patient outcomes in newly diagnosed advanced~     lung cancer patients, but previously tested models are not feasible for widespread adoption.~     Hence, the aim of this study is to pilot a more sustainable nurse-led intervention -~     Enhancing Quality of life in Patients (EQUIP).~      ii. Hypothesis / Aim The aims of this study are three-fold. Firstly, the investigators aim to~     determine the feasibility and acceptability of the EQUIP intervention itself. Secondly, the~     investigators aim to obtain a tentative estimate of efficacy of the EQUIP intervention.~     Thirdly, the investigators aim to determine the data completion rate of patient reported~     outcome measures in the context of the EQUIP trial.~      iii. Methods Patients with newly diagnosed stage 3 or stage 4 lung cancer will be recruited~     and randomized to the EQUIP intervention or usual care (control) group. Patients randomized~     to the EQUIP intervention group will receive four face-to-face sessions with a palliative~     care nurse. The content of these educational sessions will equip patients with the knowledge~     and skills to manage the three commonest symptoms of fatigue, breathlessness and anxiety.~      All participants will complete the Functional Assessment of Cancer Therapy - Lung (FACT-L),~     the Hospital Anxiety and Depression Scale (HADS) and the stigma subscale at four time points:~     baseline, 4, 8 and 12 weeks after recruitment. Measures of healthcare use will also be~     recorded. Additionally, participants in the intervention group will complete a feedback~     survey after each intervention session.~      A total sample of 60 patients (30 in each arm) will be recruited.~      Clinical Significance~      If successful, this study will lead to a larger scale phase III trial which tests various~     components of the EQUIP intervention, in order to develop a sustainable and effective model~     for the provision of palliative care to advanced lung cancer patients.~   "
58459|NCT02801721|"~     1. Burden: Anaemia is a public health problem in our country. Fifty one percent young~          children aged 6 to 59 months are suffering from anaemia in Bangladesh (BDHS-2011) and~          the main cause of this problem is iron deficiency. Research findings show that Iron~          deficiency leads to delayed development and even reduce working capacity. All these~          impact negatively on quality of life and loss of national gross domestic product (GDP).~        2. Knowledge gap: Little is known about long-term effects of early life iron deficiency~          anemia on development and behaviour of children after correction with iron supplements.~          There is also scarcity of information if early life psychosocial stimulation added to~          iron supplementation to these anemic children have long term benefits compared to~          non-stimulated anaemic children or non-anaemic children~        3. Relevance:~           The aim was to conduct a follow up study to examine whether the IDA children, who~          recovered from iron deficiency and received additional more intense psychosocial~          intervention catch up to their optimum development in later life at school age, similar~          like non-anaemic peers.~        4. Hypothesis (if any):~             1. The benefit of early iron supplementation in addition to Psychosocial stimulation~               on growth and development of IDA infants appears in later life.~             2. Addition of early psychosocial stimulation in treated IDA children help them catch~               up to their non-anemic peers in development over time.~        5. Study Objective(s)~             1. To determine the long term effect of early psychosocial stimulation provided at the~               age of 6-24 months in addition to iron treatment in IDA children on their growth~               (height, weight and Head Circumference), IQ, executive function, school~               achievement, fine motor, memory and behaviour~             2. To compare the growth and development of IDA infants with non-anemic infants after~               7 years of an intervention with iron supplementation and psychosocial stimulation.~        6. Methods:~      Sample: All children who participated in the iron and stimulation study at the age of 6 to 24~     months (n=424).~      Identification of sample: Using the addresses and by tracking through available mobile phone~     numbers.~      Measurements~      In the current follow-up, at the age of around 8-9 years all the available children will be~     measured for:~        -  WASI: The Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II)~        -  School achievement~        -  Number Stroop~        -  SDQ (strength and difficulties):The Strengths and Difficulties Questionnaire (SDQ)~        -  Memory test of NEPSY (neuropsychological test)~        -  Digit span forward and backward~        -  Middle childhood HOME~        -  Fine motor skills using the Purdue peg board or Movement Assessment Battery Children- 2~          (age -band 2 for 7-10 years)~        -  SES Anthropometric measurement: Children's height, weight and head circumference~   "
58460|NCT02801708|"~     The aim of this study is to determine the diagnostic yield of continuous 7-day Holter ECG for~     detecting covert paroxysmal atrial fibrillation in patients with recent embolic stroke or~     transient ischemic attack (TIA) of undetermined cause after completion of a standard clinical~     work up including an initial 24-hour Holter monitoring.~   "
58461|NCT02801695|"~     Pre-eclampsia (PE) complicates 2-8 % of pregnancies and is associated with high maternal and~     fetal morbidity and mortality. The early clinical manifestations are the occurrence of a~     maternal blood pressure and proteinuria. Placental dysfunction impairs the nutrient supply to~     the fetus, and may be the cause of an intrauterine growth retardation (IUGR). This is a~     disease that causes prematurity and currently the only known cure is delivery of the~     placenta. Nitrogen monoxide (NO) regulates the placental blood flow. However, pre-eclampsia~     is directly related to a failure of placental NO production. In this context, several~     clinical trials have tested the effect of NO donors such as L- arginine. However,~     supplementation with L -Arginine in a randomized trial in Nantes, has proved to be~     ineffective in severe vascular IUGR.~      Citrulline is a natural aminoacid precursor to arginine and in contrast to L-arginine escapes~     uptake in the liver and appears directly in the peripheral blood converted by the kidney in~     arginine, released into the systemic circulation, Citrulline may therefore be more effective~     in the treatment of pre-eclampsia.~      This prospective, randomized, comparative and double-blinded study aims to prolong pregnancy~     for patients with pre-eclampsia before 36 weeks.~   "
58462|NCT02801682|"~     Invasive Candida infections are serious complications in immunocompromised patients including~     those undergoing treatment for cancer but occur also in patients treated in ICUs. Survival~     rate of invasive candidiasis is associated with early initiation of antifungal therapy (15%~     mortality rate for candidemic patients with antifungal therapy on day 0 related to the~     culture date of the first blood sample positive for yeasts compared to 41% for patients who~     received antifungal therapy on day 3). Up to date, no laboratory method or clinical decision~     rule is available for correct anticipation of invasive candidiasis which would avoid delays~     in appropriate antifungal therapy initiation. In clinical practice culture based methods~     (e.g. blood cultures) miss up to 50% of invasive candidiasis cases. Preemptive antifungal~     therapy is therefore often initiated in critically ill patients after Candida has been~     isolated from various non-sterile patient samples even without any sufficient evidence for~     invasive candidiasis. The disadvantages of this approach include over- and undertreatment of~     patients (up to 50% of candidemia cases are missed, and on the other hand 89% patients are~     treated unnecessarily), increased selective pressure for the development of antifungal~     resistance, potential risk of adverse drug reactions, and increased costs (expenses for~     antifungal therapy account for half of the antimicrobial medication budget in tertiary care~     hospitals). In addition, no survival benefit could be demonstrated by this strategy in ICU~     patients.~      The aim of this study is to identify biological markers to anticipate or support the~     diagnosis of invasive candidiasis in ICU patients, to overcome current deficiencies in~     detection of invasive candidiasis and consequently to differentiate between Candida spp.~     colonization and invasive Candida infection. The investigators intend to examine time~     dependent courses of potential host and pathogen derived biomarkers as well as innate or~     acquired predispositions for invasive candidiasis; e.g. automated (1→3) ß- D- Glucan tests,~     DNA in serum blood samples, pathogen recognition receptors and serum markers like interleukin~     (IL)-1, IL-2, IL-6, IL-10, IL-12, IL-17A, IL-17F, IL-22, IL-23, Tryptophan, Kynurenine,~     composition of indigenous microbiota of gastrointestinal and lower respiratory tract and~     skin, and risk factors for invasive candidiasis like underlying diseases and treatments. The~     study should contribute to improved assessment of ICU patients at risk for invasive~     candidiasis and to improved diagnosis of invasive candidiasis in ICU patients. In clinical~     practice the reliable differentiation between infection and colonization will allow more~     targeted antifungal therapy leading to enhanced antifungal treatment initiation on the one~     hand (in cases of true invasive candidiasis) and to reduction of unnecessary antifungal~     treatments and treatment costs on the other hand.~   "
58463|NCT02801669|"~     The purpose of this study is to evaluate the efficacy and safety of edoxaban in patients with~     non-valvular NVAF aged 80 years or older who are ineligible for available oral~     anticoagulation therapy.~   "
58464|NCT02801656|"~     Clostridium difficile associated diarrhea (CDAD) is a significant cause of morbidity and~     mortality, caused by loss of healthy gut flora. Conventional treatment uses antibiotics to~     kill Clostridium difficile. A novel treatment uses replacement of gut flora by fecal~     microbiota transplant (FMT). Randomized trials have established safety and efficacy of FMT in~     recurrent CDAD, but no trial has used FMT for primary CDAD. This study will randomize~     patients to oral encapsulated FMT or oral Vancomycin.~   "
58465|NCT02801643|"~     The present study would be the first to investigate the relationship between reward- and or~     social stimuli-induced dopamine (DA) release and neural function using a combined PET/fMRI~     approach. Data from this project conducted in healthy subjects will provide preliminary data~     for a larger grant application to study patient populations with known abnormalities in DA~     including schizophrenia, major depressive, substance use, and eating disorders.~   "
58466|NCT02801630|"~     This is a double blinded randomized control trial of a Surface Acoustic Wave Patch device for~     the treatment of Trigeminal Neuralgia. This will be a crossover study for the group that~     receives the sham device. Subjects will be monitored for subjective criteria of pain and~     quality of life, as well as objective measurement of analgesic usage.~   "
58467|NCT02801617|"~     Aim: To demonstrate the non-inferiority of the PRO-067 ophthalmic solution manufactured by~     Laboratorios Sophia S.A. de C.V. versus GAAP Ofteno® ophthalmic solution like hypotensor~     therapy in subjects with primary open angle glaucoma or ocular hypertension.~      Study design: a muticentric, prospective, crossover (2x2), double blind clinical study.~     Sample size: one hundred patients with primary open angle glaucoma or ocular hypertension.~     Patients in the period 1: In the first sequence 50 patients will be assigned to receive the~     ophthalmic solution: GAAP Ofteno ® (latanoprost 0.005%) 1 drop QD during 30 days and the~     second sequence 50 patients will be assigned to receive the ophthalmic solution: PRO-067 1~     drop QD during 30 days in the same period. Washout period: 21 hours. Patients in the period~     2: the pharmcological intervention change to the opposite therapy for 30 days.~   "
58468|NCT02801604|"~     The practicality of most ADHD medications is not or only moderately examined under long term~     routine conditions. Therefore, in this multi-centre, multi-national prospective~     non-interventional study, a recommended follow-up time of 12 months will investigate the~     course of the therapy in children and adolescents with ADHD with prior MPH treatment and~     their medication change to dexamfetamine in several European countries under daily routine.~      It consists of a baseline visit under MPH or another ADHD drug therapy, a change to~     dexamfetamine, the prospective description of the titration phase and a 12 month maintenance~     phase. Data on the use of dexamfetamine in routine clinical practice will be collected to~     describe how dexamfetamine is prescribed, titrated and used in the population of ADHD~     patients and how these factors influence the general intensity of ADHD and safety events.~     This study will collect real world data of dexamfetamine and compare descriptively the~     general intensity of ADHD according to ADHD classification and the impairment due to ADHD~     under therapy with dexamfetamine to the general intensity of ADHD according to ADHD~     classification and the impairment due to ADHD under the prior therapy with MPH. Furthermore~     the utilization of dexamfetamine will be assessed with regards to treatment persistence,~     compliance, proportion of patients discontinuing treatment and reason for discontinuation.~     Due to the fact that patients will be treated according to local medical practice it is~     possible that medication will be changed during the observation period.~   "
58469|NCT02801591|"~     Observe the clinical efficacy and safety of Recombinant Human Growth Hormone Injection~     assisted in the treatment of the patients with poor ovarian response in vitro fertilization~     and embryo transfer.~   "
58470|NCT02801578|"~     Ibrutinib is currently FDA approved and commercially available for the treatment of CLL.~     However, some researchers think the approved dose may be unnecessarily high.~      The goal of this clinical research study is to compare 3 different daily doses of ibrutinib~     to learn how these doses affect the disease and your body. Researchers think that if a lower~     dose of ibrutinib can be found to be as effective as the currently approved dose this may~     help to lower the risk of side effects.~   "
58471|NCT02801565|"~     Observe validity of Recombinant Human Growth Hormone Injection assisted in IVF-ET (in vitro~     fertilization and embryo transfer) treatment of PCOS (polycystic ovary syndrome) patients.~   "
58472|NCT02801552|"~     This study evaluates the clinical effect of regenerative endodontic procedure using PRF in~     immature permanent teeth with apical periodontitis. Half of participants will receive the PRF~     instead of blood clots in the regenerative endodontic procedure, while the other half will~     receive a blood clots in the regenerative endodontic procedure.~   "
58473|NCT02801539|"~     This study is being done to test the effects of respiratory muscle training (RMT) in patients~     with late-onset Pompe Disease (LOPD) who have weakness of their breathing muscles. The~     results of this study will help design future research studies about RMT in LOPD. The goals~     of this study are to decide if sham-RMT is a useful control condition for RMT and to choose~     the best ways to measure the health benefits of RMT in LOPD.~   "
58474|NCT02801526|"~     The purpose of this study is to compare the safety and pharmacokinetics of CKD-330~     (fixed-dose combination of Candesartan 16 mg and Amlodipine 5 mg) with coadministration of~     the two separate drugs in healthy male volunteers.~   "
58475|NCT02801513|"~     Despite considerable progress in the understanding of depression, the treatment of those who~     have entered a chronic course of the disorder still represents a major challenge. In order to~     develop more effective interventions it is important to learn more about maintaining~     mechanisms and the ways in which these can be addressed. Recent research has outlined~     aberrations in neurophysiological parameters that may serve as risk factors underlying~     tendencies to engage in maladaptive responses to negative mood, and that may be particularly~     pronounced in patients with chronic depression. Initial evidence suggests that such deficits~     may not be easily amenable through established treatments. The current study investigated~     whether mental training using mindfulness mediation, as compared to an active control~     training, could alter these parameters in chronically depressed patients.~   "
58476|NCT02801500|"~     The purpose of this study is to determine whether the magnetic compressive anastomosis has a~     better outcomes than traditional manual anastomosis on superior bilioenteric anastomosis.~   "
58477|NCT02801487|"~     The purpose of this study is to determine the maximal tolerated dose (MTD) of re-irradiation~     using carbon ion radiotherapy (CIRT) along with concurrent chemotherapy in the treatment of~     locally recurrent nasopharyngeal cancer (NPC) and to evaluate the efficacy of such treatment~     at the MTD. Participants will be treated with CIRT with escalating dose regimens along with~     concurrent chemotherapy (40 mg/m^2, weekly) to evaluate the maximal tolerated dose (MTD) in~     terms of acute and subacute toxicity observed during and within 4 months after the completion~     of concurrent chemoradiotherapy. Once the MTD for locally recurrent NPC is determined, the~     MTD will be used as the recommended dose to patients fulfilling the inclusion criteria in the~     Phase II part of the trial.~   "
58480|NCT02801448|"~     Type 2 diabetes (T2D) results from a combination of insufficient insulin secretion from~     pancreatic islets and insulin resistance of target cells. The investigators have extensive~     pre-clinical data suggesting that BSE through its high content of the isothiocyanate~     sulforaphane improves hepatic insulin sensitivity. BSE as a dietary supplement could~     therefore benefit both patients with T2D and individuals at risk for the disease.~     BSE-containing sulforaphane is suggested to activate Nuclear factor-like 2 (NRF2). The~     investigators aim to study the clinical effect of using BSE as a dietary supplement on~     glucose tolerance and insulin sensitivity.~   "
58481|NCT02801435|"~     This is a phase I study to evaluate the safety, tolerability and pharmacokinetics of Icotinib~     Hydrochloride Cream in patients with mild to moderate psoriasis.~   "
58482|NCT02801422|"~     The aim of this fMRI study is to investigate neural indices of relapse in cannabis~     dependence. The development and maintenance of drug addictions have been associated with~     deficits in cognitive control, craving and impaired stress regulation. Therefore, neural~     markers of brain processes underlying the beforementioned components will be studied.~     Subsequent follow-up drug use interviews will reveal associations between relapse in cannabis~     dependence and alterations in brain networks of cognitive control, craving and stress.~   "
58483|NCT02801409|"~     Some studies suggest that regional anesthesia/analgesia may decrease the rate of~     recurrence/metastasis in patients after cancer surgery. However, evidences from prospective~     studies are still lacking. The purpose of this randomized controlled trial is to investigate~     the effect of epidural anesthesia/analgesia on the rate of recurrence/metastasis in patients~     undergoing lung cancer surgery.~   "
58484|NCT02801396|"~     Single-visit, unmasked, non-dispensing study where subjects will wear three different lenses~     bilaterally in one visit, each lens being worn for approximately 30-60 minutes. Subjects will~     complete a questionnaire for each study lens.~   "
58485|NCT02801383|"~     to assess the efficacy and safety of recombinant human interferon α-2b gel (Yallaferon®) for~     the treatment of patients with cervical HPV-16 and/or HPV-18 infections; to analyze the HPV~     type infections and clinical negative conversion.~   "
58486|NCT02801370|"~     This is a prospective, randomized, double-blind, sham-controlled, multicenter, Phase 3 study~     in which eligible subjects with acute otitis externa (AOE) will be randomized to receive a~     single administration of either 12 mg OTO-201 or Sham-Control (empty syringe) to the external~     auditory canal of the affected ear(s).~   "
58487|NCT02801357|"~     The purpose of this study is to evaluate the relative exposures of lofexidine and its major~     metabolites in subjects seeking buprenorphine dose reduction.~   "
58488|NCT02801344|"~     Protein requirements in individuals who participate in endurance-based exercise training have~     been suggested to be greater than the current recommended dietary allowance (RDA).~      Our recent study using the minimally invasive indicator amino acid oxidation (IAAO) technique~     have suggested that protein requirements in young men are at least 30% higher than the~     recommended protein intake.~      The present study will investigate the impact of protein sufficiency on protein metabolism~     and performance during intensified training periods as a means to further our understanding~     of the nutritional requirements for the endurance athlete.~   "
58489|NCT02801331|"~     The purpose of this study is to examine the efficacy of a specially-constructed crib mattress~     that delivers gentle vibrations (stochastic vibrotactile stimulation) as a complementary,~     non-pharmacological intervention for treating drug withdrawal in newborns exposed to opioids~     in utero.~   "
58490|NCT02801318|"~     Acute confusional states known as delirium frequently occur in Intensive Care Units (ICU),~     mostly after cardiac surgery, leading to serious consequences. Sleep deprivation has been~     described in ICU patients and is considered as a risk factor for delirium but its role is~     still unknown. It is therefore essential to identify whether sleep deprivation and more~     specifically REM sleep alterations could facilitate occurence of delirium in ICU.~   "
58491|NCT02801305|"~     Digital ulcers are one of the most prevalent complications of scleroderma (systemic~     sclerosis). There can be found few surveys on effect of topical agents on healing process of~     the ulcers. Thus, the aim of this study is to assess and compare the effects of topical~     diltiazem on SSc digital ulcers versus topical nitroglycerin.~   "
58492|NCT02801292|"~     The primary objective of the proposed study is to determine the potential role of Ketamine as~     an analgesic agent in pediatric sickle cell disease patients with refractory symptoms in~     acute (VOC).~   "
58493|NCT02801279|"~     The purpose of the present study is to develop a long term cost-effectiveness (efficient~     protocol, playful context, and practical strategy) training program for school-age children~     with Cerebral Palsy. Also, evaluate efficacy of Kinect-assisted bilateral arm training~     program for children with Cerebral Palsy.~   "
58494|NCT02801266|"~     This project develops a contraceptive counseling protocol (CCP) grounded in scientific~     evidence and evaluates the CCP for promoting behaviors conducive to preventing unintended~     pregnancy among women. The project develops and refines the CCP using focus groups and~     in-depth interviews with (a) key administrators in the national office of Planned Parenthood~     (b) key administrators in participating Title X clinics, (c) contraceptive counselors, and~     (d) clients of the health centers. The CCP uses scientifically grounded principles for~     guiding effective decision making and provider-client communication. Ten Title X clinics are~     randomly assigned to one of two conditions (5 clinics per condition): (1) treatment as usual~     (TAU) or (2) implementation of the CCP. Approximately 150 women are selected for study~     participation in each clinic, yielding about 1,400 participants (half control and half CCP).~     Immediately following their counseling session, women complete a computer-administered~     interview that serves as a fidelity check and permits evaluation of the effects of the CCP on~     variables associated with counseling satisfaction. All women are re-interviewed by phone 6~     months later and 12 months later. The effect of the CCP on method-choice effectiveness,~     method switching, gaps in protection, and use accuracy are evaluated.~   "
58674|NCT02798874|"~     The 'no-reflow' phenomenon after a percutaneous coronary intervention (PCI) in patients with~     acute ST-segment elevation myocardial infarction (STEMI) is a strong predictor of both short-~     and long-term mortality. Faster antiplatelet activity and increased levels of adenosine~     provide a theoretical basis for ticagrelor to effectively prevent no-reflow after PCI. We~     planned to evaluate the effects of ticagrelor on myocardial no-reflow after PCI for STEMI.~   "
58495|NCT02801253|"~     Management of prosthetic joint infections (PJI) is a challenging task. These infections~     include different clinical and microbiological settings calling upon various treatment~     strategies according to infection type (acute or chronic), bone quality, the involved~     micro-organism and the patient's general condition and willing.~      Treatment of PJI combines surgery and prolonged antibiotic therapy. In some patients with a~     high operative risk prolonged suppressive antibiotic therapy can be used.~      Lack of large prospective studies motivated the conception of this cohort with a long term~     follow up, regardless to PJI management procedures.~   "
58496|NCT02801240|"~     Individuals with IBD are at risk for nutrient deficiencies. This prospective, non-randomized,~     open-label study will assess the effect of a nutrition support product on nutritional status~     in adults with IBD. Up to ten adults with ulcerative colitis or Crohn's disease will be~     enrolled in the study and asked to take the product for 12 weeks. The primary measures of the~     study are several blood markers of nutritional status.~   "
58497|NCT02801227|"~     The purpose of the study is to compare between oxytocin to prostaglandin (PGE2), regarding~     time from induction of labor (IOL) to delivery among primiparas at term with prelabor rupture~     of membrane (PROM) and an unfavorable cervix.~   "
58498|NCT02801214|"~     This fMRI study investigates neural correlates of emotion regulation, emotion processing and~     craving in recreational cannabis users.~   "
58499|NCT02801201|"~     At the time of birth, nearly 5% of children are in breech presentation. This type of~     presentation requires a medical environment and leads to more frequent use of Caesarean~     sections. This is why the external version can be proposed, usually from the 36th week. Its~     success rate is 40%, and is usually performed under simple sedation. One of the causes of~     failure is the lack of relaxation of the uterus, which could be higher in case of deeper~     anesthesia, as is the case in spinal anesthesia. The study project is to demonstrate~     superiority of spinal anesthesia compared to the usual protocol sedation in terms of primary~     and secondary objectives.~   "
58500|NCT02801188|"~     Fracture femur is a common that results in severe pain. Many methods of regional and~     peripheral analgesia have been described to treat such pain. In this study the investigators~     consider using paravertebral block to treat post-fracture pain. Additionally, they consider~     adding dexmedetomidine to the used local anesthetic solution to prolong the duration of this~     block and hence postoperative analgesia.~   "
58501|NCT02801175|"~     Consecutive patients with paroxysmal AFib scheduled to undergo pulmonary vein isolation~     either with radiofrequency (RF) or cryoballoon will be included. Left atrial appendage~     emptying flow velocity (LAA-EFV) will be measured with transesophageal echocardiography (TEE)~     immediately before and following left atrial ablation (1 month post). The change in LAA-EFV~     will be compared between the two groups (RF versus Cryo).~   "
58502|NCT02801162|"~     Evaluate the precision and accuracy of the Proxima 3® System by obtaining quantitative~     clinical data at various time points. Compare the methods associated with obtaining blood gas~     results using the Proxima 3® System device versus a conventional ABG analyse. The aim of the~     investigator is to evaluate the precision and accuracy of the Proxima 3® ABG system~     parameters (pH, pCO2 pO2, hematocrit and potassium) in clinical practices with rapid changing~     context.~   "
58503|NCT02801149|"~     Given that: 1) various clinical complications may arise from a misdiagnosed scaphoid~     fracture; and 2) clinical and radiographic diagnosis of scaphoid fracture is often~     challenging, particularly at the time of presentation, this study aims to evaluate whether~     the use of Magnetic Resonance Imaging (MRI) in the investigation of patients presenting with~     a suspected scaphoid fracture, with negative findings from the initial conventional~     radiography (4-view plain x-ray), leads to improved levels of efficiency, quality of care and~     patient experience.~      This study is a single centre randomised, non-blinded, prospective study. Participants will~     be randomised, following the initial negative conventional radiography, to either: no further~     imaging at A&E (consistent with current clinical practice); or 2) wrist MRI. The study~     considers a follow-up period of 6 months.~   "
58504|NCT02801136|"~     This research study is examining the effects of a cognitive behavioral intervention (an~     intervention focused on changing behaviors and thoughts) for psychogenic non-epileptic~     seizures (PNES, episodes resembling epileptic seizures but with no medical explanation).~     Participants engage in 8 individual therapy sessions consisting of either cognitive~     behavioral therapy or supportive therapy. Healthy control participants also complete~     pre-questionnaires.~   "
58505|NCT02801123|"~     Background: As more people survive cancer, the importance of research on effective~     interventions for improving quality of life (QOL) amongst survivors is growing. Two~     interventions with a substantial evidence-base are Mindfulness-Based Cancer Recovery (MBCR)~     and Tai chi/Qigong (TCQ). However, these interventions have never been directly compared.~      Objectives: (1) To compare MBCR and TCQ to each other and a waitlist control condition using~     an innovative, randomized, preference-based comparative effectiveness trial (CET) design that~     takes into account potential moderating factors that might predict differential response. (2)~     To investigate the impacts of MBCR and TCQ on a range of biological outcomes including immune~     processes, blood pressure, heart rate variability, stress hormones, cellular aging, and gene~     expression.~      Methods: The study design is a preference-based multi-site randomized CET incorporating two~     Canadian sites (Calgary, AB and Toronto, ON). Participants (N total = 600). Participants with~     a preference for either MBCR or TCQ will get their preferred intervention; while those~     without a preference will be randomized into either of the two interventions. Within the~     preference and non-preference groups, participants will also be randomized into immediate~     intervention groups or a wait-list control. Outcome measures to be assessed pre- and~     post-intervention and at 6-month follow up include psychological outcomes (mood, stress,~     mindfulness, spirituality, post-traumatic growth), QOL, symptoms (fatigue, sleep), physical~     function (strength, endurance), and exploratory analyses of biomarkers (cortisol slopes,~     cytokines, blood pressure/heart rate variability, telomere length, gene expression), and~     health economic measures.~      Hypotheses: The investigators theorize that both MBCR and TCQ will improve outcomes amongst~     survivors relative to treatment as usual, particularly if patients have a strong preference~     for a particular intervention. Specifically, the investigators hypothesize that MBCR may be~     superior to TCQ on measures related to stress and mood. Conversely, TCQ may be superior to~     MBCR in improvement of physical and functional measures.~   "
58531|NCT02800772|"~     Intraduodenal acetic acid can stimulate secretion of water and bicarbonate from pancreatic~     ductal cells. In this study, acetic acid spraying to duodenal bulb was compared with saline~     solution for the facilitation of pancreatic duct cannulation in patients.The primary outcome~     was successful deep pancreatic duct cannulation. The secondary outcomes were the appearance~     of the major and minor papillary orifice, pancreatic juice flow from the papilla, time to~     achieve deep pancreatic duct cannulation, and fluoroscopy time for deep pancreatic duct~     cannulation in the acetic acid group versus saline group.~   "
58506|NCT02801110|"~     Parkinson's disease (PD) is a chronic, progressive, neurodegenerative disease that affects 1%~     of the population older than 60 years. The disease presents as a movement disorder~     manifesting mainly with resting tremor, bradykinesia, cogwheel rigidity and postural~     instability along with cognitive and behavioral disturbances and symptoms of other non-motor~     systems dysfunction. The pathophysiology of the motor dysfunction in PD is related to gradual~     loss of nigrostriatal dopaminergic neurons (originating from the substantia nigra (SN)~     compacta to the striatum) leading eventually to depletion of dopamine in the striatum.~      Striatal fluorine-18 isotopologue for L-3,4-dihydroxyphenylalanine([18F] F-DOPA) uptake~     follows a typical spatiotemporal pattern along the course of disease starting with a~     decreased uptake in the dorso-caudal putamen (contralateral to the side of predominant motor~     involvement) that progress to the caudate nucleus.~      The role of traditional magnetic resonance imaging (MRI) in the evaluation of PD is aimed~     mainly to differentiate idiopathic PD from secondary parkinsonism (e.g. vascular) and from~     other degenerative but atypical parkinsonian syndromes (e.g.Progressive supranuclear palsy (~     PSP), Multiple system atrophy (MSA) etc.) that are associated with distinct structural~     features and therefore help establishing the diagnosis. However, new MR sequences such as~     diffuse tensor imaging (DTI) and susceptibility-weighted imaging (SWI) are now being~     investigated to evaluate the nigrostriatal dopaminergic neurons and iron accumulation in the~     SN, respectively.~      Resting-state functional magnetic resonance imaging (fMRI) that depicts brain network~     organization has been shown to be altered in patients with PD. In this technique, temporally~     synchronous, spatially distributed, spontaneous low frequency blood-oxygen level-dependent~     signal fluctuations in task-free settings are further clustered into maps of functional~     large-scale neural networks. Lower network efficiency that worsens as disease progresses has~     been shown in patients with PD.~      Recently, it has been shown that the integration of MRI and PET is technically feasible. The~     investigators believe that PET/MRI offers true multimodality imaging by combining anatomy,~     function and molecular processes that will allow more accurate identification of disease~     progression.~      To the best of our knowledge, this will be the first study to evaluate idiopathic PD (IPD)~     with 18F FDOPA PET/MRI.~      The aim of the study is to assess the feasibility of the modality and to evaluate both~     visually and quantitatively the association between the dopamine metabolism measured in the~     striatum by 18F-FDOPA PET with structural and functional MR findings in patients diagnosed~     with IPD with asymmetrical motor signs.~   "
58507|NCT02801097|"~     This is a phase 1 open-label trial to evaluate the safety, pharmacodynamics and clinical~     activity of RRx-001 administered in combination with irinotecan.~      RRx-001 is associated with resensitization to irinotecan in tumors that are previously~     refractory. This effect has been attributed to the ability of RRx-001 to restore the~     expression of aberrantly silenced genes, thus re-establishing pathway functions. However,~     resensitization may have more than one mechanism, among them Pgp pump inhibition and vascular~     modulation, leading to improved penetration of standard chemotherapy.~   "
58508|NCT02801084|"~     The study proposed in this protocol aims to document the physiological, subjective,~     behavioral, and neural effects of reduced environmental stimulation (floating) in patients~     with current or prior anorexia nervosa The primary aim of this study is to determine the~     safety of this intervention. Secondary aims including determining whether floating has an~     impact on symptom reports such as those related to anxiety and eating disorders.~   "
58509|NCT02801071|"~     The purpose of the study is to show that the intake of L-citrulline improves muscle function~     in patients with Post-Polio Syndrome (PPS).~   "
58510|NCT02801058|"~     A wide number of osteopathic techniques focusing on diaphragm have been proposed but,~     although systematically and efficiently used, there is a general lack of evidences able to~     clarify how and to which extent osteopathic manipulative treatment (OMT) on diaphragm is~     effective and determines a modification in muscles contractility and motion as well as an~     objective determination of the benefit on the patients receiving treatment.~      This study therefore aims at investigating whether, and how, a single session of selected~     osteopathic diaphragmatic techniques are able to affect muscle motility and thickness,~     assessed by ultrasounds, in a sample of healthy subjects and to compare results versus a~     group receiving a sham therapy and another one of non-treated subjects.~   "
58511|NCT02801045|"~     This study evaluates from the patient's perspective which elements of the own artistic~     creative process are the source of a beneficial change for him/her and how those elements~     influence in their end of life experience.~   "
58512|NCT02801032|"~     In a double blind placebo-controlled cross-over study the effect of tadalafil on blood flow~     velocity in the large arteries of the brain, cortical brain oxygenation, peripheral~     endothelial function, and endothelial biomarkers will be tested in patients with lacunar~     stroke caused by cerebral small vessel disease.~   "
58513|NCT02801019|"~     Vitamin E incorporated highly cross linked polyethylene (E-XLPE) was developed to increase~     oxidative resistance of highly cross-linked polyethylene (XLPE) without affecting mechanical~     properties. The investigators evaluated this type of polyethylene in a randomized clinical~     study, using Radiostereometric Analysis (RSA). The objective of this study was to compare the~     early-term wear of E-XLPE to a compression annealed polyethylene liner (C-XLPE, ArComXL®).~     The clinical outcome at two years was not expected to be affected by the choice of~     polyethylene.~   "
58514|NCT02801006|"~     The aim of this study is to evaluate the clinical performance of stenfilcon A toric lenses~     compared with etafilcon A toric lenses for astigmatism. If it is valuable, the clinical~     performance of stenfilcon A toric lens is also evaluated compared with habitual lenses.~   "
58515|NCT02800980|"~     Symptomatic lymphocele (LC) can be a complication after pelvic and para-aortic~     lymphadenectomy performed for treatment or staging purposes in the management of some~     cancers. Management procedures are: single or repeated puncture, prolonged drainage with~     drains or catheters, mostly followed by sclerotherapy, or surgery. A decision, which~     management option is most optimal, should be guided by two principles: first to control~     patient's symptoms, second to apply the least invasive but effective way to treat LC, taking~     into account that the patient has undergone major surgery recently, and often needs adjuvant~     treatment at the moment when symptomatic LC is diagnosed.~      The aim of this study is to validate feasibility, safety and efficacy of a minimally invasive~     management of a symptomatic LC - drainage with the usage of vascular catheter followed by~     sclerotherapy, as well as to evaluate patient's experience on the treatment.~      Patients with symptomatic LC are evaluated with ultrasound. Data about diameters, estimated~     volume of LC and other organs failure if appear is recorded. Management options are discussed~     with patient, and if the method with catheter insertion and drainage is chosen than the~     patient is eligible for the study. After vascular catheter insertion into LC and fluid~     evacuation, patient is followed with active drainage. Patients with drainage only are~     observed for a short period of time (up to 7 days), and if not efficient a sclerotherapy is~     considered. In case a patient does not agree to sclerotherapy, or there are~     contraindications, or it is doctor's decision that drainage alone is sufficient, than the~     prolonged drainage without sclerotherapy is the only procedure. The choice about the regimen~     used for sclerotherapy, it's volume, time intervals between repeated infusion depend on~     institution practice.~      Data concerning feasibility, safety and efficacy are noted in designated templates. Patients'~     experience on the treatment is evaluated with formal questionnaire FACIT-TS-G.~      The study is observational. Primary outcome measure is to establish efficacy of the method.~     Secondary outcome measures are safety and patient's experience on the treatment.~      Investigators hope to establish step-by-step guidelines for optimal, minimally invasive~     management of symptomatic lymphocele.~   "
58532|NCT02800759|"~     Cis-9-cetylmyristoleate (CMO) is a naturally occurring fatty acid complex (FAC).~     Nutraceuticals containing CMO are used to improve knee pain despite the lack of~     placebo-controlled studies in humans. The aim of the double-blind controlled clinical trial~     is to explore the minimal effective dose of CMO for relieving knee joint pain.~   "
58516|NCT02800967|"~     The existing scientific evidence from both in vitro and clinical trials supports the notion~     that polyphenols can modulate platelet function. Beyond being central players in haemostasis~     and thrombosis, platelets have crucial roles in the development of atherosclerosis, mediated~     through their interactions with monocytes and endothelial cells. Disturbed platelet function~     correlates with other risk factors, including hypertension and obesity, and the progression~     of cardiovascular diseases (CVD), postulating platelets as rational targets in CVD~     prevention. Thus, the effects of polyphenols on disturbed platelet function would contribute~     to their pleiotropic beneficial effects of on cardiovascular health. Aronia juice is a rich~     source of polyphenols including anthocyanins, procyanidins, phenolic acids and flavonols.~     However, there is no clinical evidence on the effects of aronia juice consumption on platelet~     function and related CVD factors. The purpose of this study is to investigate the effects of~     Aronia juice polyphenols on platelet function and other CVD risk factors in subjects with~     moderate CVD risk.~   "
58517|NCT02800954|"~     The Primary objective of this study is to compare serum levels of Macrophage-Colony~     Stimulating Factor (M-CSF) in a population of patients with multiple myeloma (MM), in a~     population of patients with Monoclonal Gammopathy of Undetermined Significance (MGUS) and in~     a control population.~   "
58518|NCT02800941|"~     Pulmonary hypertension (PHT) patients often receive long term oral anticoagulants. If the~     indication is strong, in the secondary chronic thrombo-embolism pulmonary hypertension~     (CTE-PHT) prevention, the frequent prescription (50 to 90% of patients) contrasts with their~     low level of proof in the PHT. Last but not least, anticoagulants are known to be the~     principal cause of iatrogenic hospitalization (major bleeding).~      In this study, patients are all followed during one year, to determine the annual frequency~     of major bleedings (according to the International Society on Thrombosis and Haemostasis~     (ISTH) international definition). Each event notified is validated by an independent~     committee for clinical events.~   "
58519|NCT02800928|"~     A Randomized, Double-Blind, Placebo-Controlled, Crossover Design Study of CERC-501 in a Human~     Laboratory Model of Stress-precipitated Smoking Behavior.~   "
58520|NCT02800915|"~     The goal of the project is to study whether interdisciplinary follow- up performed via~     telemedicine to the patient in his or her own home, will improve the quality of the~     healthcare services offered to a particular group of patients. The investigators believe this~     could increase knowledge and expertise, give significant socioeconomic benefits, and allow~     greater accessibility to specialized healthcare services, as well as increase the~     user-involvement for patients and those working in primary healthcare.~   "
58521|NCT02800902|"~     Statins are one of the lipid lowering drugs that help in reducing cholesterol levels in the~     body by specifically inhibiting 3-hydroxy-3-methylglutaryl coenzyme A reductase; which is a~     rate limiting enzyme for cholesterol synthesis. Rosuvastatin (RSV) and atorvastatin (ATV)~     have shown to have bone stimulatory and anti-inflammatory effects.. The present study aims to~     explore the efficacy of 1.2% RSV and 1.2% ATV gel as a local drug delivery and redelivery~     system as an adjunct to scaling and root planing (SRP) for the treatment of degree II~     furcation defects.~   "
58522|NCT02800889|"~     This is a phase 1, open-label, dose escalation study to evaluate the safety,~     pharmacokinetics, and antitumor activity of pixantrone in pediatric patients with relapsed or~     refractory solid tumors (excluding those with CNS tumors) or lymphoma.~   "
58523|NCT02800876|"~     Retrospective study to evaluate the impact of computational wall stress analysis based on~     computed tomography (CT) of ruptured and not-ruptured aortic aneurysms as an additional~     predictor for rupture with dedicated software.~   "
58524|NCT02800863|"~     The purpose of this prospective, multicenter, single arm post-approval study is to~     demonstrate continued safety of the Axium Neurostimulator System for dorsal root ganglion~     (DRG) stimulation. The primary endpoint is the 12-month serious adverse event rate for~     permanent implants.~   "
58525|NCT02800850|"~     Many older adults with dementia living in long-term care facilities experience depression and~     agitation, which cause angst and personal suffering. Prior to this research, evidence was~     inconclusive but indicated that bright light exposure may reduce depression and agitation in~     long-term care residents with dementia. The purpose of this study was to determine if the~     degree of improvement in depression and agitation scores over the course of eight weeks was~     significantly greater in persons with dementia receiving bright light exposure than in~     persons with dementia receiving placebo light exposure. Sixty individuals participated in the~     study, with 30 in the bright light group and 30 in the low level light group.~   "
58526|NCT02800837|"~     Prospective, non-randomized, multi-center study assessing the long term safety and efficacy~     of the self expandable sirolimus eluting Xposition S stent in the treatment of unprotected~     left main coronary artery disease.~   "
58527|NCT02800824|"~     To evaluate the bioequivalence between the Test Product Budesonide rectal aerosol foam and~     Reference Product Uceris® rectal aerosol foam after a single-dose in healthy subjects~   "
58528|NCT02800811|"~     First-in-human, phase I, randomized, double-blind, placebo-controlled, single center study~     evaluating single and multiple ascending intravenous doses of FR104 in healthy subjects.~   "
58529|NCT02800798|"~     The purpose of this study is to find the correlation between high risk OSA (obstructive sleep~     apnea) patient, based on Stop-bang screening tool and preeclampsia~   "
58530|NCT02800785|"~     For the past 130 years, appendectomy has been the standard treatment for appendicitis. Recent~     studies from Europe have challenged the notion that surgery is the best option, showing that~     antibiotics alone can treat appendicitis without a need for appendectomy in as many as 3 out~     of 4 patients and without safety issues for up to one year of follow up. Despite these~     results, it remains to be determined if the antibiotic strategy is as good as an appendectomy~     for the outcomes that most patients care about. The Patient-Centered Outcomes Research~     Institute (PCORI)-funded Comparison of Outcomes of Drugs and Appendectomy (CODA) trial will~     be the first American, and largest-ever randomized trial of the issue and its results should~     help surgeons and patients make more informed healthcare decisions.~   "
58533|NCT02800746|"~     The objective of the present study is to determine the impact of preoperative IV-iron (ferric~     carboxy maltose) supplementation on postoperative hematocrit values and allogenic blood~     transfusion amount in patients undergoing elective prognathic surgery.~   "
58534|NCT02800733|"~     anxiety disorder is one of the major public health problems worldwide. 25% of people~     experience anxiety disorders throughout life. Generalized anxiety disorder (GAD) is known as~     the most prevalent anxiety disorder. Saffron has previously approved as an effective adjuvant~     therapy in depression and might alleviate GAD symptoms.Since up to the best of our knowledge~     no human studies have assessed the therapeutic effect of saffron as an adjuvant therapy in~     GAD patients, Therefore, this study is planned to evaluateThe effect of saffron (Crocus~     satious L.) in the treatment of mild to moderate generalized anxiety disorder:~   "
58535|NCT02800720|"~     A Randomised Controlled Trial to evaluate the effectiveness of a Second-Generation~     Mindfulness-Based Intervention known as Meditation Awareness Training (MAT) for treating~     fibromyalgia syndrome.~   "
58536|NCT02800707|"~     This study will determine the influence of two non-caloric sweeteners on glucose metabolism~     via the gut microbiome in adult men and women.~   "
58537|NCT02800694|"~     Labor pain is the most severe pain most women will endure in their lifetimes. The most~     complete and effective method of pain relief during childbirth is neuraxial labor analgesia~     which provides adequate analgesia without maternal or fetal sedation. Epidural and combined~     spinal-epidural (CSE) analgesia are the standard techniques performed in the developed~     countries. Having an epidural catheter in place produces flexibility with labor management.~     The catheter can be dosed intermittently for parturients in whom labor is prolonged, who~     require surgical manipulation for vaginal delivery, or who require cesarean section for~     delivery (1). However, unavailability of full-time epidural services in low-resource~     countries results in minimal or no analgesia provided to laboring parturients. The~     suitability of single-shot spinal analgesia has been previously studied in advanced, rapidly~     progressing labor in primiparous and multiparous women and was found that it may be a useful~     alternative for painless labor in the case of limited resources for epidural analgesia~     (2,3,4). However, duration of action is a limiting factor of intrathecal analgesia,~     particularly for primiparous women.~      A 25 μg dose of fentanyl lasts 60-90 minutes. The study investigating the dose response~     relation for intrathecal fentanyl showed that the maximal analgesic effect is achieved at~     about 25 μg fentanyl. Above this dose, the duration of action increases but with increasing~     the incidence of side effects (5). Synergy has been noted between 25 μg of fentanyl and 2.5~     mg of bupivacaine with analgesia lasting about 3 hours (6). The investigators hypothesized~     that increasing the bupivacaine dose to 5 mg with 25 μg fentanyl can prolong the duration of~     analgesia. So, this dosage combination can be used at an early stage in~     appropriately-selected primigravida parturients. The purpose of this study is to investigate~     the safety and effectiveness of single-dose spinal analgesia to control labor pain in~     properly-selected primiparous women in a tertiary referral maternity hospital~   "
58538|NCT02800681|"~     The purpose of this study is to identify psychopathology (psychiatric symptoms) that can~     differentiate between Schizotypal Disorder (SD) and Asperger Syndrome (normal IQ, no language~     impairment Autism Spectrum Disorder) (AS) in young adults.~      With our present knowledge, the differentiation between AS and SD can be difficult, as they~     both present with social difficulties, odd (but not psychotic) behaviour, and a 'feeling of~     not being as everyone else'. Studies suggest that adults with AS symptoms are either~     overlooked, or diagnosed within the schizophrenia spectrum in Adult Psychiatry.~      A 'correct' diagnosis is important, as it is the first step towards the most optimal plan,~     treatment and rehabilitation for the patient. The only way to diagnose psychiatric illness is~     the description of present psychopathology.~      To identify symptoms that can differentiate between the two disorders, we will use~     semi-structured interviews to explore present psychopathology in young adults with typical~     symptoms of SD and AS respectively, with special focus on presence of alterations in~     self-experience. Alterations in self-experience are typical for the schizophrenia spectrum,~     and are therefore not thought to be equally present in AS and SD.~      The hypotheses are that the total level of altered experiences is higher in SD, than in AS,~     and with a different pattern of altered experiences in SD than in AS. If the hypotheses are~     true, an examination of altered self-experience will be valuable to aid clinical~     differentiation between the two disorders.~   "
58539|NCT02800668|"~     Implantation of a duodenal-jejunal endoluminal bypass liner (DJBL) has shown to induce weight~     loss and to improve metabolic parameters. DJBL is a reversible endoduodenal sleeve mimicking~     biliodigestive digestion while lacking risks and limitations of bariatric surgery.~      Effects on metabolic control, body mass parameters, appetite regulation, glucose tolerance,~     organ health, and lipid profile were determined in 16 morbidly overweight patients with type~     2 diabetes mellitus. In addition, relevant hormones (Leptin, ghrelin, gastric inhibitory~     peptide, glucagon-like peptide 1, and insulin) were measured by enzyme-linked immunosorbent~     assay (ELISA) and chemiluminescent microparticle immunoassay (CMIA) at 0, 1 and 32, and 52~     weeks post-implant following a mixed meal tolerance test, which was applied for diagnostic~     purposes only.~   "
58540|NCT02800655|"~     This study uses an ingestion sensor and a wearable sensor (worn as a patch on the skin),~     which are new Proteus Digital Health (PDH) technologies approved by the FDA, to collect~     information about patients taking their ARV medications. The wearable sensor records~     information, which is uploaded wirelessly to a mobile device and then to a secure computer.~     Together the sensors and the mobile device transmitting the information to the study computer~     are called a digital health feedback system (DHFS), which gives healthcare providers~     information about when patients have taken their ARV medications.~      The purpose of the study is to demonstrate that the DHFS is easy to use and acceptable to the~     HIV patient population; that patients will persist with its use; and that the system provides~     valid, accurate measures of adherence.~   "
58541|NCT02800642|"~     Central retinal vein occlusion (CRVO) occurs when the main blood vessel that transports blood~     away from the retina (the very back portion of the eye) becomes blocked, causing the leakage~     of fluid into the retina and thereby causing a swelling of the macula (the portion of the~     retina responsible for fine vision). This swelling is called macular edema. When the macula~     swells with fluid, central vision becomes blurry. The study drug aflibercept has been shown~     to reduce the amount of fluid and blood leaked into the retina. It can help to stabilize, and~     in many cases, improve the vision loss related to CRVO. Aflibercept has been approved for the~     treatment of macular edema secondary to CRVO in the United States (US), European Union (EU),~     Japan, and other countries.~      The study is considered research because, although the study drug is already on the market~     for macular edema secondary to CRVO, there are no studies available that address the~     questions of what are useful intervals for treating and assessing patients, how do they~     differ among patients, and how are criteria applied for retreatment. The purpose of this~     study is to evaluate the effectiveness, treatment interval, and safety of the treatment~     regimen (pattern for administering treatment) in subjects with macular edema secondary to~     CRVO. In addition, this study will explore new imaging methods for assessing the affected~     eye.~   "
58542|NCT02800629|"~     The proposed study is a pilot, double-blind, randomized clinical trial comparing galectin-3~     inhibition with MCP to placebo for the treatment of knee osteoarthritis.~   "
58543|NCT02800616|"~     Unhealthy lifestyles in early childhood are a major global health challenge. These lifestyles~     often persist from generation to generation and contribute to a vicious cycle of~     health-related and social problems. We present a study protocol that examines the~     effectiveness of two novel, integrated healthy school interventions. One is a full~     intervention called 'The Healthy Primary School of the Future', the other is a partial~     intervention called 'The Physical Activity School'. These intervention approaches will be~     compared with the regular school approach that is currently common practice in the~     Netherlands. The main outcome measure will be changes in children's body mass index (BMI). In~     addition, lifestyle behaviours, academic achievement, child well-being, socio-economic~     differences, and societal costs will be examined.~   "
58544|NCT02800603|"~     The purpose of the study is to evaluate the first Canadian implementation project of the~     Family Check up (FCU), an evidence-based prevention and early intervention model that engages~     families and communities in reducing the burden of childhood emotional and behaviour problems~     (EBP).~   "
58545|NCT02800590|"~     This is a phase II, two-part, multiple-dose, dose-finding, single-blind study in adult~     participants undergoing elective colonoscopy for screening or diagnostic purposes. This study~     is designed to test various ABP-700 infusion regimens for rational selection of one or more~     dosage regimen(s) to be used for future clinical development of ABP-700 in procedural~     sedation.~   "
58546|NCT02800577|"~     In England over 800,000 patients each year are either newly diagnosed with depression or~     present with a new episode of depression in primary care. The majority of patients do not~     respond to the first drug prescribed and have to try several different antidepressants before~     an effective treatment is found. Antidepressants have a slow clinical onset of action, taking~     4 to 6 weeks before changes in mood become apparent. No test exists to guide General~     Practitioners (GPs) as to whether their patient is responding to the prescribed successive~     treatments. This often results in delays of many months before patients return to good mental~     health. The GP-ETB is a set of computer-based emotional processing tasks. It was developed~     and optimised to be sensitive to early changes in emotional bias that are indicative of~     successful antidepressant treatment. The current investigation is an exploratory study using~     the GP-ETB.~      It will test the predictive ability of the GP-ETB with regard to later subjective drug~     response and nonresponse. The study will recruit depressed patients from primary care~     settings. There are no study drugs prescribed as part of this clinical investigation.~     Eligible patients will have been prescribed citalopram by their GP prior to study entry. The~     decision to initiate treatment with citalopram will be independent of study participation.~     The duration of the study is 5 months. Each patient will be required to attend 3 visits and~     total duration of the study for the patient will be 46 weeks. During the visits patients will~     be asked to complete a variety of questionnaires and GP-ETB tasks on the computer.~     Sensitivity and specificity data collected during this study will be used to develop a~     computer algorithm intended to predict response at 46 weeks, based on GP-ETB data collected 1~     week after initiation of antidepressant treatment.~   "
58547|NCT02800564|"~     Optimal infant and young child feeding practices are largely inadequate in rural and poor~     households in Ghana. Child welfare clinics (CWCs) focus on immunization, supplementation, and~     growth monitoring and promotion (GMP) activities among infants and young children (IYC). An~     essential component of GMP activities is to counsel mothers to practice optimal IYC feeding~     and health practices, but most of the time this is completely missing or not specific enough~     to be effective.~      This study will test the effect of a mass media nutrition education program on caregiver~     infant and young child feeding knowledge, attitudes and practices using a community-based~     cluster randomized design. Formative research will first be undertaken to determine the~     beliefs, attitudes, and constraints that prevent caregivers from adequately feeding their~     infants and young children with members of the community (caregivers with children~     under-five, men and elderly women).The information gathered will then be used to design~     specific messages that directly address the IYC feeding challenges of the community. Clusters~     will be randomized into active (radio messages with in-person engagement and follow-up) and~     passive (only radio messages) arms of the intervention. Farm Radio International~     (implementers of the mass media programming) will ensure the regular broadcast of twice~     weekly messages for a period of about 12-18 months.~   "
58548|NCT02800551|"~     This study will compare pain (primary end-point) and local metastatic tumor control~     (secondary end-point) after dose-intensified image-guided fractionated stereotactic body~     radiation therapy (SBRT) for painful mass-type spinal metastases versus conventional~     radiation therapy.~   "
58549|NCT02800538|"~     The previous research by one of our members in the research team (H. Miller) suggests a~     possible influence of oral nutrients intake of certain fat or carbohydrates (glucose,~     fructose) on executive control. On the other hand, another previous study from our group (L.~     Van Oudenhove) suggests a subliminal influence of intragastric administration of fatty acids~     on subjective and neural responses to negative emotion induction. The purpose of this study~     therefore is to examine the effect of intragastric administration of certain fatty acids and~     carbohydrates on executive control in healthy volunteers.~      Therefore one group of healthy volunteers are invited to the study. The participants will be~     randomly administered one of the three fatty acid emulsions or placebo via a nasogastric tube~     in each of the visits. After the exposure period, participants will use a computer to perform~     there different tasks to measure executive control. During each study visit, regular~     measurements of emotion, physical sensations, as well as blood glucose will be assessed.~     Furthermore, an electrocardiogram will be continuously recorded for the calculation of vagal~     function.~   "
58550|NCT02800525|"~     The objective of this study is to evaluate the efficacy and safety of picosecond 532 and~     1,064 nanometers laser in the treatment of benign pigmented lesions compared with q-switched~     532 and 1,064 nanometers laser.~   "
58551|NCT02800512|"~     The purpose of this study is to compare the effectiveness of R-SCP versus HUSLS for treatment~     of pelvic organ prolapse.~   "
58552|NCT02800499|"~     The KOrea COpd Subgroup Study team (KOCOSS) cohort is an ongoing, longitudinal, prospective,~     non-interventional and observational study within the Korean COPD patients. The prevalence of~     early COPD (mild to moderate COPD based by 2011 GOLD(the Global Initiative for Chronic~     Obstructive Lung Disease) guideline) is high in Korea. However, the patients with early COPD~     are not underdiagnosed due to mild symptom. The purpose of this study is to investigate early~     COPD characteristics and disease course and to form a guideline for early detection of COPD~     patients and prevention of progression to severe COPD.~   "
58613|NCT02799693|"~     This is a single-arm non-randomized prospective observational cohort study to assess the~     outcomes of patients undergoing intramural needle catheter ablation of recurrent ventricular~     tachycardia that has failed antiarrhythmic drug therapy and standard radiofrequency (RF)~     catheter ablation. Following ablation, patients will be monitored for 6 months. The duration~     of the study is up to 4 years.~   "
58553|NCT02800486|"~     Primary brain tumors are typically treated by surgery, radiation therapy and chemotherapy,~     either individually or in combination. Present therapies are inadequate, as evidenced by the~     low 5-year survival rate for brain cancer patients, with median survival at approximately 12~     months. Glioma is the most common form of primary brain cancer, afflicting approximately~     7,000 patients in the United States each year. These highly malignant cancers remain a~     significant unmet clinical need in oncology. GBM often has a high expression of EFGR~     (Epidermal Growth Factor Receptor), which is associated with poor prognosis. Several methods~     of inhibiting this receptor have been tested, including monoclonal antibodies, vaccines, and~     tyrosine kinase inhibitors. The investigators hypothesize that in patients with recurring~     GBM, intracranial superselective intra-arterial infusion of Cetuximab (CTX), at a dose of~     250mg/m2 in conjunction with hypofractionated radiation, will be safe and efficacious and~     prevent tumor progression in patients with recurrent, residual GBM.~   "
58554|NCT02800473|"~     This study evaluates the therapeutic value of: (i) simultaneous endoscopic visualization of~     the inner bladder using white light and blue light excitations and (ii) high resolution~     panoramic images of the bladder inner wall.~      All participants will undergo fluorescence cystoscopy: the first half using first a reference~     medical device for fluorescence cystoscopy already on the market then using the innovative~     device specifically developped for the CyPaM2 project.~      The other half will undergo fluorescence cystoscopy using first the innovative then the~     reference medical device.~   "
58555|NCT02800460|"~     Deep brain stimulation (DBS) of the subthalamic nucleus (STN) is a validated procedure, used~     in many French and international centers for the treatment of severe forms of Parkinson's~     disease (PD). The improvement of parkinsonian motor symptoms by stimulation of the STN is 50~     to 80% on average. The main advantage of DBS is that the surgery has low morbidity and~     mortality, it is adaptable to the patient's symptoms and its effect is reversible. This~     treatment is now a routine and more than 85,000 patients worldwide have benefited from the~     installation of this system. Since 1997, this treatment is available to patients followed in~     the Pitié Salpêtrière (GHPS).~      The accuracy of preoperative anatomic targeting in stereotactic neurosurgery will improve~     with the use of high-field MRI. However, several new issues and inherent in that high-field~     MRI should be evaluated before the images can be used directly.~      The chosen sequences must be short to be feasible, minimizing patient discomfort, and~     evaluated on several patients to ensure the low interindividual variability. In addition, the~     quality of the display on all of the sections should provide a reliable three-dimensional~     information. Finally, the quality of targeting and its possible improvement should be~     checked.~   "
58556|NCT02800447|"~     1. To observe and compare the overall response rate (ORR) of baseline BEACOPP and ABVD~          regimens for patients with advanced Hodgkin's lymphoma.~        2. To evaluate the safety of Natulan® in Chinese patients with advanced Hodgkin's lymphoma~   "
58557|NCT02800434|"~     The double amputation of the forearms is a rare handicap that seriously impacts the autonomy~     and the quality of life of patients, social and familial exclusion, and dependence on third~     parties for everyday activities.~      The management of these patients is nearly exclusively through the use of prostheses. Certain~     patients refuse this solution, or remain penalized by the absence of sensation, the lack of~     precision in movements, and body image issues related to the amputation; the double graft of~     hands and forearms may, in this circumstance, be the only solution.~      The objective of this pilot study was designed to evaluate the cerebral plasticity of~     patients who undergo bilateral hand allograph~   "
58558|NCT02800421|"~     Besides contrast-induced acute kidney injury (CI-AKI), adscititious vital organ damage such~     as hypoxic liver injury (HLI) may affect the survival in patients with ST-elevation~     myocardial infarction (STEMI). Therefore, the investigator sought to evaluate the prognostic~     impact of CI-AKI and HLI in STEMI patients who underwent primary percutaneous coronary~     intervention (PCI).~   "
58559|NCT02800408|"~     The purpose of this study is to determine how well the body absorbs the carotenoid~     beta-cryptoxanthin (BCX) from a type of corn that has been naturally bred (not genetically~     engineered) to contain higher amounts of BCX than traditional breeds of corn. Because this~     new type of corn contains higher amounts of BCX, it appears more orange in color than~     traditional types of corn. Understanding how well the body can absorb the BCX from the corn~     may help companies develop food products that may have improved nutritional quality.~   "
58560|NCT02800395|"~     According to several reports, the oxidative stress and the nutrition could have an impact in~     the Alzheimer disease.~      The association of these two parameters measurements and the cognitive impairment decline~     could help in a predictive diagnosis of cognitive decline evolution in patients presenting~     cognitive disorders.~      This is a monocentric prospective routine care clinical trial on patients showing cognitive~     troubles especially memory complaints.~      The objective is to demonstrate a correlation between oxydative stress and nutrition~     biomarkers and the clinical evolution of patients complaining of cognitive impairments.~      The neuropsychologic data collection (the mini mental Status Examination (MMSE), the clock~     test, the Grober-Buschke test (FCSR-IR), the executive function evaluated by the Trail making~     test, and the medical imaging (by magnetic resonance imaging (MRI) or tomography in case of~     MRI contraindication) will be realized during the study inclusion phase in the usual intake~     of patients. Whole blood samples for the oxydative and nutrition biomarkers measurements will~     be taken at the study inclusion day during the stay at the Day hospital dedicated to the~     routine intake of patients issued from the memory consultation.~      In this study, the principal evaluation criteria will be the MMSE score evolution during the~     60 months of the patients follow-up, measured during the routine visits scheduled~     approximately every 6 months, according to the french national authority for health~     recommendations. It will allow evaluating the correlation between the cognitive decline~     evolution measured by MMSE during the Alzheimer disease or related diseases method during the~     2 years follow-up, and the oxydative stress blood markers.~   "
58561|NCT02800382|"~     Lipid per oxidation final products and free oxygen radicals are thought as initiator role for~     developing of cancer in the body. Level of paraoxonase in the patients with cancer varies. In~     this research, the investigators investigated the contribution of level of serum and~     bronchoalveolar lavage paraoxonase in the differentiation of benign and malignant lung~     disease patients. This research includes the patients that are diagnosis of lung cancer~     (research group) and benign pulmonary disease (control group) participated by accepted~     fiberoptic bronchoscopy (FOB).~   "
58562|NCT02800369|"~     This research study is being carried out to study a new way to possibly treat human cervical~     intraepithelial neoplasia (CIN) without invasion.~      Persistent infection with specific types of human papillomavirus (HPV, most frequently types~     16 and 18) may lead to precancerous lesions(CIN). If untreated, these lesions may progress to~     cervical cancer within many years. In the infected cells, HPV expresses the oncoproteins E6~     and E7, both of which play key roles in maintaining viral infection and promoting~     carcinogenesis. Previous studies has demonstrated that E7 alone, but not E6, is sufficient to~     immortalize human keratinocytes in vitro and induce high-grade cervical dysplasia in a~     transgenic mouse model. These data indicated that E7 may dominate the malignant progress in~     HPV-infected cells.~      The agents zinc finger nucleases (ZFNs), called ZFN-603 and ZFN-758, which can cleave the~     HPV16 and HPV18 E7 oncogene specifically. ZFN-mediated disruption of HPV16 and HPV18 E7 DNA~     directly decreased the expression of E7, induced type-specific apoptosis in HPV16- and~     HPV18-positive cells, and inhibited cell growth.~      The purpose of this study is to determine whether ZFN-603 and ZFN-758 are effective in the~     treatment of HPV16- and HPV18-positive cervical intraepithelial neoplasia.~   "
58563|NCT02800356|"~     To evaluate the effectiveness of subthreshold laser treatment on retinal sensitivity in~     patients with reticular pseudodrusen and incipient Geographic Atrophy (GA) secondary to~     Age-Related Macular Degeneration (AMD). Secondary objective is to investigate changes in~     best-corrected visual acuity, atrophy progression and safety.~   "
58564|NCT02800343|"~     Metabolic acidosis is a common complication that patients experience in the early~     postoperative period following cardiac surgery. Increasingly, the composition and volume of~     intravenous fluids administered during surgery have been implicated in the development of~     postoperative acidosis. Intraoperative Cell Salvage (ICS), an autologous blood transfusion~     technique employed by Cardiac/Perfusion Units to minimize blood loss during surgery, involves~     the infusion of of one such fluid, 0.9% sodium chloride. The rapid infusion of large volumes~     of 0.9% sodium chloride has previously been linked with the development of hyperchloraemic~     acidosis. We hypothesize that the volume of mechanically salvaged of red blood cells~     re-infused into patients undergoing heart surgery contributes to the acidosis that occurs in~     the early postoperative period.~      To test this, we have designed an observational cohort study to check for correlation between~     the volume of cell salvaged blood infused during surgery and the severity of postoperative~     acidosis (which will be assessed using data from routine arterial blood gas samples).~   "
58565|NCT02800330|"~     Regorafenib is a novel oral multi-kinase inhibitor which targets angiogenic, stromal and~     oncogenic receptor tyrosine kinases. It is currently registered for GIST and mCRC. When~     regorafenib is co-administered with an acid suppressive agent, the intra-gastric pH~     increases, and as a result the equilibrium of ionized/non-ionized regorafenib may shift to~     the less soluble non-ionized form which reduces regorafenib bioavailability and exposure.~     Since proton pump inhibitors (PPIs) are often used during regorafenib therapy, this drug-drug~     interaction (DDI) confronts pharmacists and oncologists with challenges in clinical practice.~     In this study the investigators will therefore evaluate the impact of PPI-induced~     intra-gastric pH elevation on regorafenib pharmacokinetics in patients with GIST and mCRC.~   "
58566|NCT02800317|"~     Chemotherapy in clinically node positive breast cancer patients is increasingly administrated~     in a neoadjuvant setting. The standard treatment regimen in these cases is then: neoadjuvant~     chemotherapy (NAC) followed by breast surgery and an axillary lymph node dissection (ALND).~     NAC results in axillary pathologic complete response (pCR) in 1 out of 3 patients, indicating~     a complete absence of axillary metastases after completion of NAC. In such events, ALND can~     be regarded as overtreatment that creates unnecessary morbidity. Less invasive axillary~     surgery which can accurately assess axillary pCR is therefore preferred over standard ALND in~     all patients. In case of detection of remaining axillary lymph node metastases by this less~     invasive axillary surgical procedure, completion axillary treatment is standard of care.~      The novel RISAS procedure is introduced as a possible less invasive axillary staging~     procedure. RISAS procedure contains Radioactive Iodine Seed localisation in the Axilla in~     axillary node positive breast cancer combined with a Sentinel node procedure. The iodine seed~     in the axillary lymph node metastasis will be placed prior to start of NAC.~   "
58567|NCT02800304|"~     M2E is a developmental evaluation of the implementation of the Integrated Nutrition Pathway~     for Acute Care, in five medical units in five hospitals in Canada.~   "
58568|NCT02800291|"~     M3 is a multi-site cross sectional study. Data were collected form 640 residents in 32 homes~     in Canada. The primary purpose of this study was to identify food intake in residents and~     compare this to recommendations, as well as determine influential determinants of food~     intake.~   "
58569|NCT02800278|"~     Usually, cervical spine fractures are not considered as osteoporotic fractures. However,~     recent studies show that odontoid fractures are the most common fractures of the cervical~     spine in elderly and may occur in a context of low trauma energy. Thus, the goal of this~     observationnal study is :~        -  to describe the different type of odontoid fracture and to characterize bone status in~          elderly patient (>65 y) who underwent odontoid fracture in a context of low trauma~          energy.~        -  To describe short and long term outcomes~   "
58570|NCT02800265|"~     Avmacol is an over-the-counter dietary supplement containing broccoli seed and sprout~     extracts in tablet form, hypothesized to activate protective cellular pathways including~     detoxication. In this study, healthy volunteers will take 3 days of Avmacol in order to~     evaluate both bioavailability and its bioactivity in cheek cells.~   "
58571|NCT02800252|"~     Therefore, the aim of this study is to investigate the effectiveness of daily supplementation~     of omega-3 polyunsaturated fatty acids and low-dose aspirin as adjunct therapy to one-stage~     full-mouth periodontal ultrasonic debridement for the treatment of chronic periodontitis in~     type 2 diabetic patients through a superiority randomized clinical trial.~   "
58614|NCT02799680|"~     The purpose of this study is to evaluate the safety and efficiency of allogeneic cluster of~     differentiation 33 (CD33)-directed chimeric antigen receptor modified T cells (CART-33)~     infusions in patients with relapsed / refractory acute myeloid leukemia (AML).~   "
58615|NCT02799667|"~     The investigators aim to show that single use negative pressure dressings can decrease the~     rate of wound complications in obese women (BMI > 40 kg/m2) undergoing cesarean delivery at a~     tertiary medical center by randomizing women to receive either a single use negative pressure~     dressing or the standard dressing after cesarean delivery.~   "
58572|NCT02800239|"~     Protein requirements in active individuals have been suggested to be greater than the current~     recommended dietary allowance (RDA).~      Nutritional requirements for dietary amino acids in adolescents have traditionally been~     determined utilizing the nitrogen balance technique, which is prone to underestimating~     protein requirements. As a result, there is a need to re-evaluate recommendations in order to~     characterize how dietary amino acid needs may be modulated by physical activity.~      Recent studies using the minimally invasive indicator amino acid oxidation (IAAO) technique~     have suggested that protein requirements in young men are at least 50% higher than the RDA~     based on nitrogen balance data.~      The purpose of this study is to measure the protein requirement in adolescent, females using~     the IAAO technique in the presence of a variable intensity exercise stimulus.~   "
58573|NCT02800226|"~     This pilot study aims at exploring the efficacy of iTBS compared to 10Hz protocol and explore~     potential biomarkers of treatment response~   "
58574|NCT02800213|"~     Investigators compared tidal volumes for single rescuer ventilation using a modified bag~     valve mask with a supplemental external handle versus a conventional bag valve mask in a~     manikin model.~   "
58575|NCT02800200|"~     The platelet rich plasma (PRP) and extracorporeal shock wave therapy (ESWT) are new and~     potential treatment for patients with kinds of musculoskeletal disorders. Although few~     clinical studies have showed beneficial effect of PRP and ESWT for regeneration of peripheral~     neuropathy, the effect of combined PRP and ESWT is absent so far.~   "
58576|NCT02800187|"~     The shock wave is a new and potential intervention for the reinnervation of peripheral nerve.~     The purpose of this study was to assess the dose effect of extracorporeal shock wave therapy~     on carpal tunnel syndrome.~   "
58577|NCT02800174|"~     To validate the long-term effects of implantation of the self-expanding Smart nitinol stent~     system for the treatment of severe atherosclerotic carotid stenosis in a 2-year follow-up~     study of a large patient cohort~   "
58578|NCT02800161|"~     The ongoing research on bipolar disorder (BD) has highlighted its pervasive and debilitating~     nature, characterized by lifelong recurrent episodes and residual intraepisodic~     symptomatology. Epidemiologic, comorbidity, cost-of illness, and mortality studies have~     reported dramatic illness-associated morbidity and premature mortality in bipolar patients.~     The efficacy and safety of antidepressant drug treatment in BD is the subject of~     long-standing debate based on a scientific literature that is limited and inconsistent. The~     evidence base for the use of antidepressant drugs in BD is strikingly weak, and there is~     insufficient evidence for treatment benefits with antidepressants combined with mood~     stabilizers. The need to develop new agents for the treatment of depression, and in~     particular bipolar depression, with better efficacy and/or tolerability, remains unmet. In~     the past years there has been increasing interest in the health benefits of supplemental~     and/or dietary substances in the treatment and prevention of depression. The disaccharide~     trehalose protects cells from hypoxic and anoxic injury and suppresses protein aggregation.~     In vivo studies with trehalose show cellular and behavioural beneficial effects in animal~     models of neurodegenerative diseases. Moreover, trehalose was shown to enhance autophagy, a~     process that had been recently suggested to be involved in the therapeutic action of~     antidepressant and mood-stabilizing drugs. In fact, trehalose may have antidepressant-like~     properties and that the trehalose induced behavioral changes are possibly related to~     trehalose effects to enhance autophagy. Furthermore, preliminary data indicates that~     trehalose also augments lithium effects in animal models (mice). Based on this hypothesis,~     this project aims to conduct a study to assess the efficacy and tolerability of trehalose as~     adjunctive treatment to lithium in bipolar depression.~   "
58579|NCT02800148|"~     To compare the bioequivalence of Perrigo's azelaic acid foam product to Finacea Foam for the~     treatment of Inflammatory Lesions of Rosacea~   "
58580|NCT02800135|"~     Acute kidney injury (AKI) is a common disorder and associated with high morbidity and~     mortality. However, distinguishing transient AKI from persistent AKI may help in~     individualizing treatment and limit short and long term consequences of AKI. Previous studies~     suggested usual urinary indices to perform poorly for separating transient from persistent~     AKI in an unselected population of critically ill patients. The recent KDIGO (Kidney Disease~     Improving Global Outcomes) guidelines underlined the need for additional strategies in~     estimating renal short term prognosis.~      Recently, a Furosemide stress test (FST) was validated in a cohort of unselected critically~     ill patients. This stress test performance was found to be good in predicting capacity to~     identify those patients that will progress to advanced stage AKI. Additionally, FST~     performance was higher than those of usual renal biomarker. The limited sample size of this~     preliminary study however precluded adjustment for usual confounders including oliguria.~      The primary objective of this study is to assess diagnostic performance of FST in~     differentiating transient and persistent AKI. Secondary objectives are to assess diagnostic~     performance of FST in predicting need for renal replacement therapy, and to confirm FST~     results after adjustment for confounders.~   "
58581|NCT02800122|"~     This is an observational retrospective single-center study (CHRU of Nancy) in patients cared~     for acute dyspnea by a medical team of the emergencies of the CHRU of Nancy.~      The main purpose of the study is to evaluate the outcome of patients cared for acute dyspnea~     by a medical team of emergencies of CHRU of Nancy.~   "
58582|NCT02800109|"~     The purpose of this study is to measure the impact of maternal malaria on child growth in the~     two first years of life in relation to fetal growth.~      This study is following a birth cohort of children born to pregnant women enrolled in the~     study Impact of malaria infection in pregnancy on fetal and newborn growth (protocol OXTREC~     14 08 and Mahidol 2009-003-01). In this cohort growth monitoring is conducted until 2 years~     of age using routine anthropometric measurements such as weight, length, arm and head~     circumference. A few additional tests will enhance the sensitivity of the study outcomes with~     minimal risk. These tests will include anthropometry, screening, nutrition questionnaire and~     neurodevelopmental assessment.~   "
58583|NCT02800096|"~     Comorbidity between problem gambling and mental health concerns such as anxiety and~     depression is common. Further, the treatment needs of people with co-occurring gambling and~     mental health concerns may be different from those of problem gamblers who do not have a~     co-occurring mental health concern. The present study is a two-arm, double blinded, parallel~     group randomized controlled trial (RCT) that will evaluate whether there is a benefit to~     providing access to mental health Internet interventions (G+MH intervention) in addition to~     an Internet intervention for problem gambling (G-only intervention) in participants with~     gambling problems who do or do not have co-occurring mental health concerns.~   "
58616|NCT02799654|"~     In this Post Market Clinical Follow-up Study (PMCF Study), the short-term clinical and~     radiological results of the cementless Excia T® prosthesis in routine clinical use shall be~     assessed and the migration taking place in the first 24 months evaluated.~   "
58584|NCT02800083|"~     -  The study primary end point is the decrease in the number of monthly heavy drinking days~          (HDD) (≥ 60 g/day in men and ≥ 40 g/d in women) from baseline to the end of the double~          blind Randomized Treatment (RT).~        -  The Secondary end points will be designed to assess safety and tolerability and to~          further investigate the effect of pitolisant on other alcohol use criteria (e.g. total~          alcohol consumption, number of abstinence days), craving as well as the improvement in~          mental health (depression, sleep) and quality of life.~             -  Total alcohol consumption (TAC) from baseline to end of treatment. TAC was defined~               as mean daily alcohol consumption in g/day over a month (28 days).~             -  Percent of patients without HDDs during the 24 weeks RT phase of the study.~               (Continuous Controlled Drinking=CCD)~             -  Percent of Abstinent Days during RT phase (PAD)~             -  Continuous Abstinence Duration from baseline during 24 weeks RT phase (CAD)~             -  4-week point prevalence abstinence at end of treatment~             -  Improvement in alcohol biomarkers (e.g. ALAT, ASAT, % CDT) during 24 week RT phase~             -  Craving (Obsessive Compulsive Drinking Scale) during 24 week RT phase~             -  Beck Depression Inventory (BDI) during 24 week RT phase~             -  Quality of sleep (Pittsburgh Sleep Quality Index) during RT phase.~             -  Treatment retention during 24 week RT~             -  Quality of life (SF-12) during RT phase~             -  Percent patients without HDDs during the OL follow up period~             -  Quality of life (SF-12) during OL phase~             -  Quality of sleep (Pittsburgh Sleep Quality Index) during OL phase~             -  Treatment retention OL phase Safety will be assessed by evaluation of treatment~               emergent adverse events (TEAE), physical examinations, clinical laboratory tests~               (blood chemistry, hematology, and urinalysis), subsequent end of treatment~               potential withdrawal, evaluation scales and physical examination, measurement of~               heart rate, blood pressure, and body weight at each study visit )V0-FU5). If at ECG~               Fridericia's corrected QT interval ≥ 500 ms or if difference to baseline is ≥ 60 ms~               it will be required to check ECG by second measurement after lying down 10 minutes.~   "
58585|NCT02800070|"~     This is a first-in-human study for the treatment of Fabry disease. Eligible patients will~     have an autologous stem cell transplantation using CD34+ cells that are transduced with the~     lentivirus vector containing the human alpha-gal A gene. The researchers of this study would~     like to see if the re-introduction of transduced cells will help increase the levels of~     alpha-gal A enzyme levels and to determine the safety and toxicity of autologous stem cell~     transplantation using CD34+ cells transduced with lentivirus vector containing the alpha-gal~     A gene. This study's objective is to determine the safety and toxicity of lentivirus~     alpha-gal A transduced CD34+ cells in adult males with Fabry disease.~   "
58586|NCT02800044|"~     The overall goal for this pilot clinical trial is to explore the accuracy and acceptability~     of a non-invasive, wearable glucose sensor in patients living with DM. This study will~     compare needleless glucose sensor readings with glucometer measurements from patients with~     type 1 or type 2 diabetes (T1DM or T2DM), under varying conditions.~   "
58587|NCT02800031|"~     To compare between the efficacy of IOTA simple rules and pattern recognition method in the~     differentiating between benign and malignant adnexal masses~   "
58588|NCT02800018|"~     The first aim of this study is to analyse perinatal risk factors leading to hypoxic ischaemic~     encephalopathy in term and near term neonates born in Switzerland who were admitted to the~     neonatal and intensive care units offering hypothermia therapy.~      Further, investigators would like to analyse the influence of these perinatal risk factors on~     the severity of encephalopathy during and after hypothermia therapy.~   "
58589|NCT02800005|"~     As the number of obesity continues to increase, surgical oncologist pay more attention to the~     effect of obesity on surgical outcomes and survival of digestive systemin cancers. Body mass~     index(BMI) is one of the most widely used measurements of obesity. Abdominal fat area (AFA)~     calculated by computed tomography is popular because of its validity of fat distribution.~     There is still no consensus which of BMI and AFA could be the more effective measurement and~     more accurate to evaluate effect of obesity on surgical outcomes and survival. Gastric cancer~     is one of the most common digestive system cancers, and gastrectomy is the primary~     therapeutic options.It is important to compare the different measurements(BMI or AFA) to~     assess obesity and effect on surgical outcome and survival for gastric cancer patients.~   "
58590|NCT02799992|"~     Acute central serous chorioretinopathy (CSC) is a common disorder in middle-aged patients,~     characterized by serous retinal detachment in the macular region. We evaluated half-dose~     verteporfin photodynamic therapy (hd-PDT) versus 689 nm laser treatment in chronic CSC.~      Twenty-two eyes of 22 patients with symptomatic chronic CSC were randomized in a 1:1 ratio to~     receive hd-PDT (group 1) or 689-LT delivering 95 J/cm2 by application of an intensity of 805~     mW/cm2 over 118 seconds. Best-corrected visual acuity (BCVA) and spectral-domain optical~     coherence tomography findings were compared between groups.~   "
58591|NCT02799979|"~     Pulmonary hypertension is a rare and severe disease, affecting a young population. Survival~     is very poor and has been closely related to right ventricular dysfunction. Current~     prognostic equations rely mostly on right heart catheterization data. The identification of~     simple echocardiographic prognostic factor is urgently needed. It could help identifying with~     a non invasive method, high risk patients who could benefit from an intensive specific~     therapy. 3D right ventricular imaging is a new echocardiographic tool which provides RV~     volumic analysis, RV ejection fraction, overcoming the classical limits of 2D ultrasound.~      The aim of this study is to validate a new software for 3D analysis of the right ventricle~     and assess its prognostic role in pulmonary hypertension.~      To do so, the investigators will realize a prospective monocentric longitudinal cohort study,~     including 100 pulmonary hypertension patients. Echocardiographic data will be collected at~     baseline and after 6 months.~   "
58592|NCT02799966|"~     Many individuals with cervical spinal cord injury (SCI) have difficulty using their hands and~     arms. MyndMove is a non-invasive medical device that uses short, low energy electrical pulses~     with surface electrodes to cause muscle contractions to produce a full range of reaching and~     grasping movements, which the patient is unable to perform by him/herself.~      By using MyndMove therapy to help the individual move their arms and hands as he/she attempts~     to carry out typical reaching and grasping movements, the individual improves their ability~     to perform these tasks voluntarily.~      The purpose of this study is to study the effectiveness of MyndMove therapy in improving the~     ability of individuals to move their arms and hands.~   "
58617|NCT02799641|"~     Does the addition of cervical lidocaine injections and valium to the current practice result~     in decreased reported pain with tenaculum placement, IUD insertion, and post procedural~     discomfort? The current practice is ibuprofen alone or no medication.~   "
58675|NCT02798861|"~     The primary aim is to determine the accuracy of CAP in the quantification of liver steatosis~     using liver biopsies as reference. Secondarily, investigators will correlate transient~     elastography (TE) and CAP results, analyze possible associations between CAP/TE and~     post-liver transplant (LT) clinical outcomes, and evaluate the change in CAP after LT. The~     study aims to include as many donors as needed to achieve 100 transplanted liver allografts.~   "
59271|NCT02791048|"~     This study aims to find out if music therapy is effective in improving the quality of life of~     palliative care patients. It will do this by comparing palliative care patients who receive~     music therapy with those who do not receive music therapy.~   "
58593|NCT02799953|"~     Objective: To develop and evaluate a technology-augmented self-monitoring model using a~     randomized controlled trial to demonstrate whether patients with co-morbid type 2 diabetes~     mellitus and hypertension can improve their glycemic and blood pressure control, adherence to~     medication regimens, and other relevant outcomes by using a tablet-based consumer health~     information technology (CHIT) to support the self-monitoring and self-management of their~     chronic conditions.~      Design: A two-group, randomized controlled trial with follow-up assessments 8, 12, 16, and 24~     weeks after the baseline evaluation.~      Setting: Patients' homes.~      Participants: Two hundred and ninety-six adult patients with type 2 diabetes mellitus and~     hypertension who receive their health care from a local community health service network or a~     major hospital will be recruited.~      Interventions: Participants in the technology-augmented self-monitoring model (intervention~     group) will use a tablet-based, interactive touch screen self-monitoring system to monitor~     and manage their chronic conditions. The system is designed to augment patients' abilities to~     assess, record, and review their health signs while providing text-, audio-, and video-based~     resources supporting disease self-care. The participants in the usual-care group will perform~     conventional self-monitoring.~      Outcome measures: The primary outcomes will be glycemic control measured by changes in~     HbA1c,blood pressure control assessed by changes in systolic and diastolic blood pressure,~     and medication compliance. The secondary outcomes will be adherence to diabetes and~     hypertension self-care activities and knowledge of diabetes and hypertension.~      Implication: This study will improve our understanding of the clinical value of CHITs in~     chronic disease self-monitoring and self-management.~   "
58594|NCT02799940|"~     The objective of the study is to determine the correlation between the physiological~     variables and the degree of consolidation in lung computed tomography in patients with acute~     respiratory distress syndrome~   "
58595|NCT02799927|"~     Objective: The study's main purpose is to evaluate and compare the clinical and radiographic~     outcomes of Biodentine and a light-activated calcium hydroxide based-liner (Ultra-Blend~     plus®) as indirect pulp treatment (IPT) liners, over the dentin-pulp complex of vital primary~     molars with carious lesions approaching the pulp. Study design: 80 four-to-eight year-old~     patients were enrolled from a Mexican University Pediatric Dentistry Clinic. A split-mouth~     design trial is being conducted in order to compare both IPT interventions on 160 bilateral~     primary teeth, without signs or symptoms of irreversibly inflamed or degenerative pulp~     tissue. Teeth were treated and restored with a preformed crown in a single session, and then~     closely followed-up for 1, 3, 6, 12, 18, and 24 months.~   "
58596|NCT02799914|"~     Post market clinical follow-up study about the Sinus-venous stent. Patients with venous~     iliofemoral occlusive disease are treated with the Sinus-venous stent. This observational~     study will provide 1 year data about safety and efficacy.~   "
58597|NCT02799901|"~     Combining nivolumab with conventional multisite high dose radiotherapy seems to be an~     interesting approach that could increase the antitumoral effect of nivolumab by increasing~     the diversity and quantity of tumoral antigen presentation thanks to radiotherapy.~     Multifractionated high dose radiotherapy (HR) targeting various tumor sites could also~     increase occurrence of tumor mutations and the diversity of the T-cell receptor repertoire of~     intratumoral T cells.~      The purpose of this study is to combine nivolumab with 3 fractions of HR of one metastasis~     for each tumor site (defined as skin/muscle, thoracic, abdomen, bone, other).~      The investigators hypothesize that combining nivolumab with multisite, multifractionated HR~     increases the overall survival rate at 1 year compared to published data with nivolumab~     alone.~   "
58598|NCT02799888|"~     HLA-mismatched unrelated donor (MMUD) and HLA-haploidentical donor (Haplo Donor)~     hematopoietic stem cell transplantation (HSCT) is associated with increased~     graft-versus-host-disease (GVHD) and impaired survival. The chemokine receptor 5 (CCR5)~     antagonist maraviroc has immunomodulatory properties potentially beneficial for GVHD control~     as it can blockade lymphocyte chemotaxis without impairing T-cell function. The aim of this~     study is to evaluate the safety and efficacy of maraviroc combined with standard~     graft-versus-host-disease prophylaxis in patients with hematologic malignancies after~     allogeneic stem cell transplantation from HLA-Unrelated or HLA-Mismatched Related donors.~     Based on the results of our previously small sample study with maraviroc combined with~     cyclosporine/tacrolimus and methotrexate for prophylaxis of GVHD, the investigators plan to~     perform the clinical trail.~   "
58599|NCT02799875|"~     Preterm infants, less than 37 weeks gestation with respiratory distress syndrome, who remain~     ventilated between 7 and 14 days after birth will be randomized to a ventilator strategy of~     either a higher level of permissive hypercapnia or of a lower level of permissive hypercapnia~     to determine if either strategy will increase the number of alive ventilator-free days in the~     28 days after randomization.~   "
58600|NCT02799862|"~     This is a single-arm non-interventional study (NIS) to evaluate the effectiveness, safety and~     quality of life (QoL) in patients with advanced NSCLC receiving the combination of~     nab-paclitaxel and carboplatin as first line palliative therapy in a real life setting.~   "
58601|NCT02799849|"~     A significant weight gain and obesity are observed for most patients with narcolepsy, mainly~     at the beginning of the disease and narcolepsy in young children. There is no specific study~     on the population and the consequences of overweight in the lives of these long-term~     patients. Narcoleptic patients gain weight significantly at the onset of their illness. It is~     also known that weight gain is not related to the treatment of narcolepsy. The etiology of~     obesity in narcoleptic patients is not established. Several assumptions were made (physical~     activity, leptin diet, metabolism). The reason and the pathophysiology of overweight and~     obesity in this population therefore remain unclear.~      In this study, potential change in the total metabolism (24h) for narcoleptic children that~     could explain their tendency to obesity will be assessed ?~   "
58658|NCT02799082|"~     The aim of the study was to evaluate the efficacy and safety of BF-200 ALA (Ameluz) used with~     photodynamic therapy (PDT) in patients suffering from actinic keratosis.~   "
58659|NCT02799069|"~     The aim of the study is to evaluate the non-inferiority of BF-200 ALA (Ameluz) in the~     treatment of actinic keratosis (AK) with photodynamic therapy (PDT) compared to Metvix.~   "
58660|NCT02799056|"~     The primary objective is to assess whether the fraction of diaphragmatic shortening in~     combination with the presence / absence of alveolar-interstitial syndrome evaluated through~     chest ultrasound may predict successful extubation in adult patients hospitalized in the~     intensive care unit.~   "
58602|NCT02799836|"~     Amblyopia is a significant health problem, affecting up to 4% of the population in the United~     States. Amblyopia, commonly known as lazy eye, is a developmental visual disorder in which~     one or both eyes suffer from poor vision as a result of being disadvantaged in early life.~     Strabismus, or eye misalignment, such as crossed eyes (esotropia) or wandering eyes~     (exotropia), and anisometropia, or a power difference between the eyes, are the most common~     causes of amblyopia. If conventional treatment, such as patching the better seeing eye, is~     not initiated during the critical period of visual development, lasting visual impairment may~     persist throughout life. This critical period of visual development has been thought to end~     around age 10. However, recent research has demonstrated that the critical period of visual~     development can be extended into adulthood. Complete light deprivation in animal models has~     restored plasticity in the visual cortex and has demonstrated drastic recovery of vision in~     amblyopic eyes. The objective of this pilot study is to evaluate the impact of complete light~     deprivation on visual function in a cohort of human adults with severe amblyopia from~     anisometropia.~   "
58603|NCT02799823|"~     The purpose of this study is to evaluate the safety and performance of the HLT System in~     patients with severe aortic stenosis who present at High Risk for aortic valve replacement~     surgery.~   "
58604|NCT02799810|"~     In a prospective longitudinal cohort study we aim at investigating the extent to which~     pre-transplant psychosocial levels of functioning predict the medical and psychosocial~     outcomes of lung transplantation. There is evidence that e.g. persistently elevated~     depressive symptoms are associated with reduced survival after lung transplantation~   "
58605|NCT02799797|"~     This study compares the long-axis and short-axis technique of continues adductor canal block~     for total knee replacement surgery. Half participants will receive long-axis catheterization,~     while the other half will receive short-axis catheterization.~   "
58606|NCT02799784|"~     The primary objective of this study is to assess the effect of umeclidinium/vilanterol~     (UMEC/VI) versus tiotropium/olodaterol (TIO/OLO) in subjects with moderated COPD.~      This is a multicentre, randomized, open label, 2 period crossover complete block design~     study.~      Eligible subjects, who complete a 2-week run-in period, will be randomized to receive a~     sequence consisting of UMEC/VI inhalation powder (62.5/25 microgram [mcg] once-daily [QD])~     administered as 1 inhalation via the ELLIPTA® Inhaler and TIO/OLO 5/5 mcg inhalation spray~     administered as 2 inhalations via the RESPIMAT® inhaler, for 8 weeks each. This will be~     followed by a 3-week washout period and one-week follow-up period. The total duration of~     subject participation in the study will be approximately 22 weeks.~      ELLIPTA is a registered trademark of the GlaxoSmithKline group of companies. RESPIMAT is a~     registered trademark of Boehringer Ingelheim.~   "
58607|NCT02799771|"~     HYPID-2 study is an extension of HYPID study (NCT01443598) :~      HYPID-2 is also an observational and prospective study of patients with interstitial lung~     disease and pre capillary hypertension diagnosed by right heart sided catheterization.~      It concerns only incident patients (i.e patients included within 6 months after PH diagnosis)~     whereas HYPID concerned prevalent and incident cases.~      The primary aim is the same than HYPID : identify prognostic factors~   "
58608|NCT02799758|"~     The purpose of this study is to demonstrate the superior efficacy of NK-104-CR 8 mg daily~     compared to Livalo® IR 4 mg daily on fasting serum low-density lipoprotein cholesterol~     (LDL-C) reduction and to evaluate the comparative safety of NK-104-CR 8 mg daily to Livalo®~     IR 4 mg daily after long-term treatment~   "
58609|NCT02799745|"~     The primary purpose of this study is to compare the time to prostate cancer progression~     (pathological or therapeutic progression) between patients treated with enzalutamide versus~     patients undergoing active surveillance.~   "
58610|NCT02799732|"~     This feasibility study was developed to evaluate the proposed approaches for enrollment,~     sample collection, interview and retention over a six-month vaccination period for the~     clinical trial: A scientific evaluation of one and two doses of the bivalent and nonavalent~     prophylactic HPV vaccines (1DT) currently under development . These aspects will be assessed~     quantitatively and qualitatively by measuring the efforts needed to identify and recruit each~     study participant, the participation rate for the study, and the retention rate at six~     months, as well as collecting information on the acceptability of study procedures. To~     supplement the assessment of the acceptability of the self-collected swab among older girls,~     a parallel effort will be done at the end of this feasibility study. Combined, this~     feasibility work will allow for modifications to the design, approaches and methods of the~     new trial.~   "
58611|NCT02799719|"~     Overweight and obesity have become an increasing problem in patients on hemodialysis.~     However, in virtually all observational studies in chronic kidney disease(CKD) and dialysis~     patients , using body mass index(BMI) as metric fat mass is associated inversely with death~     rate. Nevertheless, it is questionable that obesity can be considered an unequivocal~     protective factor in chronic diseases as increase body fat mass appears to be a potential~     cause of the chronic inflammation frequently present in these patients. The consequences of~     this inflammation are impaired nutritional status, accelerated atherosclerosis, and increased~     mortality. In the present study, by using dual-energy X-ray absorptiometry (DEXA) and~     bioimpedance spectroscopy (BIS) to evaluated the contributions of fat mass to outcomes in an~     observational cohort of hemodialysis patients. Besides, we aim to assess the relationship~     between body fat composition, clinical metabolic risk profiles, measures of adiposity, such~     as waist circumference (WC), visceral adiposity index, waist-to-hip ratio (WHR), and~     waist-to-height ratio (WHtR), markers of inflammation and adipocytokines in these maintenance~     hemodialysis patients.~   "
58612|NCT02799706|"~     The primary objective of the trial is to assess if GnRH antagonists in combination with~     external beam radiation therapy improve progression free survival (progression that can be~     biological, clinical, or death) compared to GnRH agonists in combination with external beam~     radiation therapy.~      Secondary objectives include:~        -  documentation of effect of GnRH antagonists on clinically significant cardiovascular~          events in the subgroup of patients at high risk of such events at baseline;~        -  documentation of side effects and quality of life, I-PSS and urinary tract infections;~        -  assessment of relative treatment effect on secondary efficacy endpoints (clinical~          progression, time to next line of systemic therapy, time on therapy, overall and cancer~          specific survival) and on PSA at 6 months after end of RT.~   "
58618|NCT02799628|"~     The trust between patients and medical providers is the cornerstone to obtain success~     treatment. To boost the trust can increase medical prescription compliance, enhance patient~     satisfaction, and improve the effectiveness of treatment. Otherwise, mistrust between medical~     providers and patients will result in ineffective treatment and excessive defensive health~     care. This situation may cause medical dispute and medical resources wasting problems.~      Most of treatment complete in a few times of admissions and interventions. So, how to improve~     the trust between patients and doctors quickly became a more knotty problem. Several studies~     found that speech (including listening, showing compassion, and take longer to explain),~     reputation, clothing, offer a newer therapy were more important than age, title, and sex.~      However, past researches were restricted to an unclear causal relationship. That is they~     can't be determined whether good doctor-patient relationship and better trust conditions~     create a longer visit time, better satisfaction, and good reputation, or vice versa. They~     also unable to clarify whether the high degree of trust result in improved treatment effects,~     or good relationship result from good medical outcomes.~      Investigators want to design a randomized control trial by giving patients recommendation and~     physical therapist introductions to enhance the trust of patients to therapists. And this~     study may verify whether enhance trust between therapists and patients will lead to changes~     in treatment effectiveness.~   "
58619|NCT02799615|"~     This multicenter study is being conducted to determine whether infliximab exposure after an~     initial infusion is predictive of early clinical response in hospitalized pediatric patients~     with severe steroid-refractory UC or IBD-U. This pilot and feasibility study will establish~     the infrastructure, demonstrate feasibility, and collect preliminary data to support the full~     study.~   "
58620|NCT02799602|"~     The purpose of the study is to assess the efficacy and safety of BAY1841788 (darolutamide~     (ODM-201)) in combination with standard androgen deprivation therapy (ADT) and docetaxel in~     patients with metastatic hormone sensitive prostate cancer.~   "
58621|NCT02799589|"~     This study intends to show the efficacy of remifentanil-dexmedetomidine infusions in~     combination with a caudal block for patients ages 1 year to 3 years old receiving elective~     surgery to investigate alternatives to the currently used volatile anesthetics.~   "
58622|NCT02799576|"~     The investigators hypothesized that using the curved needle could facilitate the block~     placement and provide short procedure time. Aim of the work: The investigators will compare~     namely straight and curved block needle with in-plane needle insertion techniques for the~     infraclavicular brachial plexus nerve block (ICNB) regarding the block performance time.~   "
58623|NCT02799563|"~     A 2-by-2 factorial cluster randomized controlled trial was performed to: 1) Compare the~     effects of supervised (coached) versus unsupervised (no coach) administration of the DKA~     simulator on trainees' knowledge of DKA management immediately after (primary outcome) using~     the simulation and 3 and 6 months post-intervention (secondary outcome); 2) Determine whether~     a preselected number of DKA simulator practice cases or a self-selected number~     (self-regulated learning) of DKA simulator practice cases will result in superior trainee~     knowledge with respect to DKA management immediately after (primary outcome) and 3 and 6~     months post-intervention (secondary outcome).~   "
58624|NCT02799550|"~     The purpose of this study is to evaluate the safety and efficiency of allogeneic cluster of~     differentiation 19 (CD19)-directed chimeric antigen receptor modified T cells (CART-19)~     infusions in patients with relapsed / refractory B-cell acute lymphoblastic leukemia (B-ALL)~   "
58625|NCT02799537|"~     Our goal is to compare two types of advance directives forms available in English and Spanish~     to determine which is more easy to use for patients.~   "
58626|NCT02799524|"~     The objective of this study is to evaluate the scales commonly used in geriatrics and~     oncology distress thermometer ( analogue scale rated from 0 to 1 for the emotional distress )~     , the GDS15 (15 issues closed binary response seeking signs of depression ) the HADS (14~     questions assessing the intensity of anxiety signs and signs of depression listed 0-3 ).~      The prospective observational study will be conducted in parallel on two sites ( University~     Hospital Centre and François Baclesse ) after informed patient information.~      It will be offered to patients 70 years and over with a new diagnosis or relapse of cancer or~     haematological malignancies in the hospital to meet the mood disorder screening~     questionnaires .~   "
58627|NCT02799511|"~     A transient ischemic attack (TIA) should be considered an emergency prevention opportunity in~     order to avoid recurrence as cerebral infarction (CI) serious (fatal or disabling). Indeed,~     about 20% of patients who have IC had in previous days or weeks, a TIA, which can be defined~     as a brief episode of cerebral dysfunction (or eye) do not result in permanent brain damage~     and thus no sequelae. Moreover, about 20% of ischemic events observed in practice are AIT.~     Despite the progress achieved in the treatment in the acute phase of an IC, prevention~     remains the most effective way to fight against this disease. This prevention can be put in~     place before the occurrence of a first IC, or after a first IC, especially when minor as a~     TIA.~      However, the diagnosis of TIA remains particularly difficult and it is necessary now to~     identify new tools for the diagnosis of transient ischemic attack. Our study focused on the~     identification of one or more molecules (called biological markers or biomarkers) present in~     the bloodstream of patients, which will serve to facilitate the differential diagnosis of~     patients with TIA.~   "
58628|NCT02799498|"~     The purpose of the study is to compare Pharmacokinetics of liquid etanercept that is~     administered to healthy subjects aged 18-55 by an auto-injector device and manual injection~     (each subject received both injections).~   "
58629|NCT02799485|"~     This phase II trial studies recombinant EphB4-HSA fusion protein (EphB4-HSA) in treating~     patients with Kaposi sarcoma. Recombinant EphB4-HSA fusion protein may block the growth of~     blood vessels that provide blood to the cancer, and may also prevent cancer cells from~     growing.~   "
58661|NCT02799043|"~     A prospective, multicenter, randomized study to assess the safety and effectiveness of~     FIRM-guided procedures in conventional redo RF ablation procedures for the treatment of~     persistent and paroxysmal atrial fibrillation.~   "
58662|NCT02799030|"~     This was a placebo controlled, double blind, randomized phase II dose-response study to~     evaluate the efficacy and safety of BF-200 ALA (containing the active ingredient 5 -~     aminolevulinic acid- ALA) used with photodynamic therapy (PDT) in patients with actinic~     keratosis (AK).~   "
58630|NCT02799472|"~     This study is designed to explore the activity of granulocyte-macrophage colony stimulating~     factor (GM-CSF) signaling pathway in subjects with rheumatoid arthritis (RA), the potential~     impact of inhibition of this axis by GSK3196165, and to evaluate whether there are any~     differences in the GM-CSF axis between subjects with early RA compared with those with more~     established disease. This study also aims to establish the potential impact of GSK3196165 on~     inflammatory structural joint damage in the hand/wrist using magnetic resonance imaging~     (MRI). This is a randomized Phase IIa, multi-center, double-blind, placebo-controlled~     parallel group study. Approximately 40 subjects with active RA despite treatment with~     disease-modifying antirheumatic drugs (DMARDs) (including conventional or biologic) will be~     randomized into the study, following a screening period of up to 6 weeks. The total treatment~     period is up to 10 weeks, with a 12-week follow-up period after the last dose (Week 22).~   "
58631|NCT02799459|"~     Hypnosis in conization is more and more use to substitute General Anesthesia (GA) in~     Anesthesia's field.~      This study wants to prove that the Hypnosis in conization are cheaper.~   "
58632|NCT02799446|"~     The purpose of this study is to determine whether Reslizumab is effective for the treatment~     of chronic sinusitis.~   "
58633|NCT02799433|"~     This randomized controlled trial uses administrative public health screening data to test~     whether the Healthy Apple program (HAP), designed to support local implementation of national~     Let's Move! Child Care guidelines in San Francisco (SF), improves child care center nutrition~     and physical activity practices and child weight change.~   "
58634|NCT02799420|"~     The purpose of this study is to conduct a study on genetic pathology, obtaining of pure~     cancer tissues is mandatory. Although the endoscopy with biopsy has been a gold standard for~     diagnosing gastric cancer, percentage of cancer cells in biopsy samples is usually 30% or~     less. Recently, confocal laser endomicroscopy has been introduced for real-time~     histopathologic diagnosis in various cancers. In previous pilot study in our institution,~     pCLE-targeted biopsy provided superior results in terms of the proportion of cancer cells in~     biopsy samples compared to WLE-targeted biopsy, especially for gastric cancers with~     undifferentiated histology. However, there was a limitation because of small sample size.~     Therefore, the investigators aim to evaluate that biopsy using probe-based confocal laser~     endomicroscopy for undifferentiated gastric cancer will increase the percentage of cancer~     cells and expression ratio of tumor marker in biopsy samples.~   "
58635|NCT02799407|"~     The purpose of this study is to compare the modular, multi-tiered consent process featured in~     Apple's ResearchKit (RK) to the standard consent process. The primary objective is to~     determine whether participants using the ResearchKit consent form have a significantly higher~     comprehension of the elements of consent than participants using the standard consent form.~   "
58636|NCT02799394|"~     The purpose of this study is to investigate the effect of activity modification, exercises~     and a gradual return to sport in adolescents (age 10-14) with Osgood Schlatter disease. The~     primary outcome is self-reported recovery on a 7-point Likert scale at 3 months. Secondary~     endpoints include 4 and 8 weeks and 6 and 12 months after inclusion into the project. The~     adolescents will be recruited from primary schools, general practitioners and through online~     advertising on Facebook.~   "
58637|NCT02799381|"~     The primary objective of this study is to examine the effect of levodopa-carbidopa intestinal~     gel (LCIG) compared with optimized medical treatment (OMT) on dyskinesia in participants with~     advanced Parkinson's disease (PD).~   "
58638|NCT02799368|"~     As iodinate contrast media (CM) has been widely used in current medical practice, contrast~     induced acute kidney injury (CI-AKI) has been an important issue.~      Previously, many guidelines suggested prophylaxis protocol using 0.9% saline when CM is~     administrated to high risk patients. However, recent studies showed that 0.9% saline might~     induce metabolic acidosis due to its supra-physiologic chloride component, and therefore~     renal vasoconstriction. In spite of protective effect by volume expansion with saline~     infusion, this renal vasoconstriction might have conflicting effect on renal function, as~     hypoxic injury is suspected to be the main cause of CI-AKI.~      In contrast to 0.9% saline, balanced salt solution has physiologic level of chloride and~     neutral pH. Also, recent studies proved preventive effect of balanced salt solution for AKI~     in several clinical settings.~      Hence, the investigators planned a prospective randomized controlled trial comparing 0.9%~     saline and balanced salt solution to prevent CI-AKI.~   "
58639|NCT02799355|"~     Of the six main genotypes of the hepatitis C virus (HCV), genotypes 2 and 3 account for~     approximately 30% of chronic infections worldwide. In North India, Genotypes 3 and 1 account~     for 95% of chronic hepatitis C patients The first three direct-acting antiviral agents to~     receive FDA approval—boceprevir, telaprevir, and simeprevir—do not currently have a role in~     the treatment of genotype 3 infection. In contrast, the direct-acting antiviral agents,~     daclatasvir and sofosbuvir, have good activity against all genotypes. The SVR rates of 90 -~     100% in genotype 3 were achieved with oral sofosbuvir plus ribavirin regimen to 24 weeks.~     Similar SVR rates were achieved in Genotype 1 with oral sofosbuvir plus weight based~     ribavirin and Pegylated Interferon alpha 2 a. However, the ongoing discovery and development~     of agents that directly target various stages of HCV replication are likely to provide~     HCV-infected patients with effective interferon-free therapy. HCV genotype 3 infection is~     associated with a higher incidence of hepatic steatosis, more rapid progression of fibrosis,~     and possibly a greater risk of hepatocellular carcinoma than is HCV genotype 2~     infection.Moreover, patients with HCV genotype 3 infection are less responsive to~     peginterferon based treatment than are patients with HCV genotype 2 infection.~   "
58640|NCT02799316|"~     Hepatitis B virus (HBV) infection is a challenging health problem. According to the World~     Health Organization, an estimated 240 million individuals (3.7%) suffered from chronic HBV~     infection worldwide.~      After acute hepatitis B virus (HBV) infection, the disappearance of hepatitis B surface~     antigen (HBsAg) had generally been believed to signify viral elimination. However, it now~     becomes clear that those subjects may have occult HBV infection which is defined as the~     presence of HBV DNA in the liver in the absence of HBsAg in the serum. Occult HBV infection~     usually accompanies antibody against hepatitis B core antigen (anti-HBc) and/or antibody~     against HBsAg (anti-HBs), but some cases might not have these serological markers~     (seronegative occult HBV infection) .~   "
58663|NCT02799017|"~     Participants will receive either intensive phonology or semantic feature analysis treatment~     for 16 weeks to improve naming, reading, and writing in individuals with chronic post-stroke~     aphasia.~   "
58641|NCT02799303|"~     In this open randomized controlled trial, we seek to study whether prostate cancer screening~     using multiparametric prostate magnetic resonance imaging (mpMRI) improves the detection rate~     of clinically-significant prostate cancer (defined as Gleason score ≥7 on prostate biopsy)~     compared with prostate cancer screening using prostate-specific antigen (PSA).~      The current paradigm of prostate cancer screening relies upon an initial PSA blood test, with~     subsequent investigations driven by the serum PSA level. This model has proven highly~     controversial due to the inability of PSA level to discern between indolent and aggressive~     forms of prostate cancer. As a result, numerous government-sponsored bodies have recommended~     against PSA screening. Evidence suggests that prostate cancer screening has led to an~     increased proportion of men being diagnosed with potentially curable prostate cancer.~     However, due to the inability of the PSA level to accurately distinguish patients with~     indolent and lethal forms of prostate cancer, it has led to a significant rate of~     over-diagnosis of indolent disease. Magnetic resonance imaging has been gaining an~     increasingly large role in the management of patients with clinically-localized prostate~     cancer including diagnosis in patients with abnormal PSA levels, monitoring of patients on~     active surveillance and staging prior to definitive interventions. MRI-based prostate cancer~     risk assessment has been shown to better distinguish between clinically-significant and~     insignificant tumors than PSA test. Therefore, a randomized controlled trial of MRI-based~     prostate cancer screening and PSA-based prostate cancer screening is warranted.~   "
58642|NCT02799290|"~     Adipose Tissue Extract (ATE) has been found to be an antologous source of growth factors with~     proven in vitro angiogenic and adipogenic properties.It is obtained by a simple~     lipoaspiration procedure. We sought to compare the effect of ATE with another known source,~     platelet-rich plasma to compare the wound healing characteristics on skin graft donor sites.~   "
58643|NCT02799277|"~     The main goal of this project to investigate the psychological processes underlying moral~     judgments in social dilemmas. WE will examine neuroendocrine determinants of moral judgment~     by investigating the effects of exogenous testosterone~   "
58644|NCT02799264|"~     Cabotegravir is being developed for the treatment of human immunodeficiency virus (HIV) 1~     infection. Specifically, it is being developed as a component of a 2-drug maintenance regimen~     (post-induction of viral suppression) that includes rilpivirine. Rilpivirine requires food~     for optimal absorption; therefore the recommended intake of cabotegravir in the planned Phase~     3 treatment studies is with food regardless of fat or calorie content, when administered~     along with rilpivirine. This is a single-center, randomized, open-label, two-way crossover~     study in healthy adult subjects to assess the effect of a high fat meal on the single dose~     pharmacokinetics of CAB 30 mg. Approximately, 24 subjects will be enrolled in the study and~     will be screened for 30 days. Twelve subjects with at least 10 hours of fasting will be~     randomized to receive a single dose of cabotegravir orally (Schedule 'A'). The remaining 12~     subjects will receive a single dose of cabotegravir orally along with high fat meal (Schedule~     'B'). After 15 days, the subjects earlier undergoing 'Schedule A' will be switched to~     'Schedule B' and those undergoing 'Schedule B' will undergo 'Schedule A'. All the subjects~     will be followed up to 30 days from the day of receiving first dose of cabotegravir to~     evaluate the effect of a high fat meal on the pharmacokinetics of cabotegravir.~   "
58645|NCT02799251|"~     Postoperative infections are one of the most common complications in thoracic and digestive~     cancer surgery. Former studies have demonstrated that inflammatory response is altered during~     peri-operative period causing lymphopenia. It has been suggested that lymphopenia may~     contribute to postoperative infection. To date, no one has proved it in a multivariate~     analysis. The aim of this study is to determine if lymphopenia is associated with~     postoperative infections in thoracic and digestive cancer surgery.~   "
58646|NCT02799238|"~     This is a randomised, open-label, multi-centre, Phase II study in patients with newly~     diagnosed glioblastoma.~      Up to 87 patients with newly diagnosed glioblastoma will be enrolled in the study in a 1:2~     allocation (standard of care (SOC): ALECSAT as an adjunct therapy to SOC).~      Data from a further 29 patients gathered from an ongoing observational study of glioblastoma~     patients treated according to SOC at Sahlgrenska University hospital in Göteborg, Sweden will~     be used as historical control data and combined with the randomised control data in~     performing the statistical analysis.~      Patients recruited into this study will receive either:~        -  ALECSAT as an adjunct therapy to standard of care for newly diagnosed glioblastoma~          (first line therapy: Stupp regimen, followed by second line therapy at the~          Investigator's discretion) or~        -  Standard of care therapy for newly diagnosed glioblastoma (first line therapy: Stupp~          regimen, followed by second line therapy at the Investigator's discretion).~   "
58647|NCT02799225|"~     Enterobacteria constitute a family of Gram negative bacilli of the gastrointestinal flora.~     These micro-organisms are frequently responsible for nosocomial or community-acquired~     infections, for which treatment is essentially based on the use of beta-lactam antibiotics.~     This class of antibiotics comprises penicillins, cephalosporins, monobactams and carbapenems.~     Carbapenems have the advantage of possessing a broad antibacterial spectrum and the capacity~     to resist the hydrolytic action of a large number of beta-lactamases, widespread inactivating~     enzymes.~      However, new enzymes, called carbapenemases, able to confer resistance to carbapenems either~     alone or in combination with additional resistance mechanisms such as loss of membrane~     permeability or overexpression of efflux systems, are currently emerging all over the world.~     Carbapenemases represent a major public health problem because of the risk of therapeutic~     impasse and their high epidemic potential.~   "
58648|NCT02799212|"~     Most patients undergoing hepatectomy for hepatocellular carcinoma (HCC) suffer from~     underlying liver disease and are exposed to the risk of postoperative ascites, with~     subsequent morbidity, liver and renal failure, the need for specific treatments and prolonged~     hospital stay. Postoperative ascites is favored by an imbalance between portal venous inflow~     and the diminished hepatic venous outflow. Finding a reversible, non-invasive method for~     modulating the portal inflow would be of interest: it could be used temporarily during the~     early postoperative course to prevent acute portal hypertension. Somatostatin, a well-known~     drug already used in several indications, may limit the risk of postoperative ascites and~     liver failure by decreasing portal pressure after hepatectomy for HCC in patients with~     underlying liver disease.~   "
58673|NCT02798887|"~     Ridge Preservation Comparing the Clinical and Histologic Healing of Membrane vs. no Membrane~     Approach to Grafting.~   "
58649|NCT02799199|"~     Objectives: This study describes efficacy and safety of Fingolimod in patients treated for at~     least 6 months in the east of France from January 2011 to December 2014.~      Background: The Grand-Est is a geographical region in France with a high prevalence of~     multiple sclerosis (more than 10000 patients registered in the European Database for Multiple~     Sclerosis (EDMUS) database). In this region and since January 2011, more than 1014 patients~     have been treated for at least 6 months with Fingolimod, the first oral therapy for patient~     with very active relapsing-remitting MS.~      Methods: Features of patients followed up in the Grand-Est region and treated with fingolimod~     in the 6 university hospitals, general hospitals and private neurologists were reviewed in a~     retrospective study after identification of the clinical files reported in the EDMUS~     database.~   "
58650|NCT02799186|"~     Spontaneous Coronary Artery Dissection (SCAD) is a rare and often misdiagnosed cause of Acute~     Coronary Syndrome (ACS) affecting predominantly young women without cardiovascular risk~     factors. The origin of SCAD remains uncertain but a strong and frequent association with~     Fibromuscular Dysplasia (FMD) has been recently reported based on imaging evidence only.~      The aim of our study is to assess the presence of FMD and its genetic determinants i in a~     sample for haematoma or spontaneous coronary artery dissection.~      From May 2016 to 2018 we plan to include prospectively and retrospectively 200 patients~     admitted for ACS with confirmed diagnosis of SCAD. This study will be conducted in more than~     30 French interventional cardiology centers. Coronary angiograms or intracoronary imaging~     data will be reviewed by two experienced interventional cardiologist experts in SCAD~     diagnosis.~      For each patient a genetic analysis will be performed. A systematic screening for FMD will be~     realized by computed tomographic or MRI angiography of renal, cerebrovascular and iliac~     arteries and reviewed by two experienced radiologists. A one year follow-up is expected.~      This study aims to confirm the presumed association of FMD and SCAD through the exploration~     of several artery beds and the study of confirmed genetic determinants, which has never been~     described previously to our knowledge.~   "
58651|NCT02799173|"~     Patients with Systemic lupus erythematosus (SLE) are known to present an increased risk of~     osteoporosis and cardiovascular calcification. It has also been suggested that bone~     remodelling and cardiovascular calcification are regulated by the same mechanisms, but~     inversely in terms of calcium deposition, as osteoporosis is often associated with~     cardiovascular calcification. Inflammatory and immune factors have been implicated in these~     two processes.~      The role of the RANKL/OPG system in osteoclast differentiation has been elucidated over the~     last ten years. RANKL induces differentiation of monocytes-macrophages into osteoclasts,~     while, inversely, OPG exerts an inhibitory role by inactivating RANKL. Differentiation of~     smooth muscle cells into osteoblasts in the vessel wall induces calcification, and this~     phenomenon is counterbalanced by differentiation of monocytes into osteoclasts. Although the~     role of the RANKL/OPG ratio in the pathogenesis of osteoporosis has now been clearly~     established, its role in vascular calcification is only hypothetical at the present time.~      This study will focus on patients with SLE diagnosed and followed in the Amiens University~     Hospital Internal Medicine and Nephrology departments~   "
58652|NCT02799160|"~     This observational study evaluates the clinical, biochemical and haemodynamic effects of~     large-volume paracentesis (LVP) in 50 patients with and without signs of inflammation~   "
58653|NCT02799147|"~     Several groups have demonstrated very low incidence of acute and chronic graft-versus-host~     disease (GVHD) with post-transplantation cyclophosphamide (PTCy) in haploidentical, unrelated~     and related allogeneic stem cell transplantation (SCT). Nonetheless for majority of the~     grafts, except for 10/10 HLA-matched bone marrow, with this type of prophylaxis require~     concomitant administration of calcineurin inhibitors±MMF, which delays immune reconstitution~     and development of graft-versus-leukemia (GVL) effect. So, despite reduction of~     transplant-related mortality, use of PTCy doesn't lead to the reduction of relapse incidence.~     This is particularly important for relapsed or refractory acute leukemia patients, where,~     despite all efforts to intensify conditioning regimens, relapses after SCT occur in more than~     50% of patients, and long-term survival rarely exceeds 10-20%. In preclinical model of~     haploidentical SCT the substitution of post-transplantation cyclophosphamide with~     bendamustine, led to comparable GVHD control, but significantly augmented GVL effect. To test~     this hypothesis and improve the outcome of allogeneic SCT in refractory acute leukemia~     patients we initiated a pilot trial with high-dose post-transplantation bendamustine for GVHD~     prophylaxis. The selection of doses is based on the previous dose-escalation studies.~     Additional immunosuppression could be added for mismatched grafts.~   "
58654|NCT02799134|"~     CAR is short for cortisol awakening response. The neural mechanism of CAR effect on~     high-order cognition and social cognition is less known...~   "
58655|NCT02799121|"~     This prospective case series is to gain additional clinical experience in the treatment of~     diabetic foot ulcers, by documenting and relating patient history (including baseline wound~     characteristics) and clinical outcomes (incidence of healing, rate of healing, and patient~     and physician satisfaction) in a group of study participants for whom the ReGenerCell™~     Autologous Cell Harvesting Device (ReGenerCell™) is used in combination with conventional~     therapy for the closure of diabetic foot ulcers (DFUs). Participants will receive~     ReGenerCell™ treatment in addition to standard care (debridement, cleansing, dressings,~     offloading).~   "
58656|NCT02799108|"~     Recent data published by various laboratories as well as our preliminary data tend to prove~     that near-infrared spectroscopy can be used to determine the lateralization of language as~     part of the preoperative assessment for drug-resistant epilepsy. The reference test used up~     until very recently was the Wada test, which consisted of injecting an anaesthetic (generally~     amobarbital sodium) into one of the internal carotid arteries (right or left) in order to~     determine the predominant cerebral hemisphere for language. This invasive test has been~     progressively replaced by fMRI, which is nevertheless difficult to perform in children under~     the age of 7 years. NIRS therefore appears to be a useful alternative, which, in contrast~     with fMRI, can be easily repeated and allows simple investigation of the various facets of~     language (e.g. expressive, receptive). In the GRAMFC unit, the investigators have acquired a~     unique know-how in the field of high-resolution NIRS, both in epilepsy and in the development~     of language structures.~   "
58657|NCT02799095|"~     To better understand the safety and tolerability of ALKS 4230 in humans~   "
58664|NCT02799004|"~     Pain is one of the most common complaints in emergency department (ED) and is still often~     poorly managed. A major prospective multicenter study reported that 74% of patients that had~     a pain complaint at ED triage are discharged in moderate to severe pain. Accordingly,~     physicians frequently prescribed analgesic after discharged for these patients, and opioid is~     given in 29% of ED visits involving pain complaints. However, few studies evaluate pain~     management after ED discharge: the frequency and length of opioids prescriptions, the opioids~     quantity taken by the patients, are the patients relieved and satisfied by these pain~     treatments, what are the adverse effects associated with the use of these medications, and~     what are the chances of developing addiction?~      The primary aim of this study is to determine the required minimal opioids prescription for~     patients treated for acute pain after being discharge from the ED. Secondary objectives~     include: 1) monitor the patients' adverse events during opioids treatment; 2) evaluate the~     patients' level of pain relief associated with their respective opioids treatment; 3)~     determine the patients' level of addiction following post-ED opioids treatments.~      The design of the project is a prospective observational cohort study. A cohort of~     consecutive ED patients aged 18 or more with an initial pain at triage of 4 or more and~     discharged from the ED in less than 48 hours with a prescription of opioid will be asked to~     participate in the study. Patients will be excluded if there is ongoing treatment for a~     pre-existing chronic pain condition or if they used opioid drugs in the past year. Research~     nurses will contact the patients by phone at three follow-up time points (1 week, 1 month,~     and 3 months). Follow-up phone interviews will evaluate pain intensity as well as pain~     treatment satisfaction (0-10 NRS), monitor adverse events, and investigate possible opioids~     addiction (SOWS: subjective opioid withdrawal scale). During these interviews, the nurses~     will also question the patients about their daily opioids usage and if they were relieved~     from pain.~      This study will provide the base for future guidelines regarding the prescription of opioids~     treatment for specific pathology encountered in ED. It will also give indications on how to~     adjust the treatments according to adverse events and the level of addiction experienced by~     patients.~   "
58665|NCT02798991|"~     The current study is designed to assess the safety, tolerability, pharmacokinetics (PK),~     gastrointestinal (GI) transit time and pharmacodynamic (PD) biomarkers of repeat oral doses~     of GSK3179106 administered for 14 days in normal healthy subjects. It is a randomized,~     double-blind, placebo-controlled, ascending cohort study. A total of 48 subjects will be~     randomized (8 subjects/cohort) with 3:1 allocation to GSK3179106 or matching placebo.~   "
58666|NCT02798978|"~     This study is an ascending dose first-time-in-human study to determine the safety,~     tolerability, pharmacodynamic (PD), and pharmacokinetics (PK) profile of GSK1795091 in~     healthy subjects. The results will support the design of future clinical trials of GSK1795091~     administered to subjects with advanced malignancies in combination with immune system~     modulators.~      Part 1 will be a randomized, double-blind (sponsor-unblinded), placebo-controlled, single~     center, single dose escalation, sequential group evaluation of intravenously administered~     GSK1795091 to evaluate the safety and tolerability in healthy subjects. Part 2 will be an~     open-label, parallel group evaluation of 2 doses of GSK1795091 administered, either 1 week~     apart (Part 2, Cohort 1) or 2 weeks apart (Part 2, Cohort 2). In Part 2, on Day 1, subjects~     will receive intravenous GSK1795091 at a dose determined by results from Part 1. The total~     duration of this study is approximately 10 weeks from screening to the last study visit.~   "
58667|NCT02798965|"~     Lymphocytic thyroiditis is the most common autoimmune disease, usually affecting young women.~     Although the aetiology and pathogenesis remain obscure, the most widely accepted hypothesis~     is an interaction between a genetic predisposition and an environmental trigger factor such~     as viral infection. Parvovirus infections have been proposed as trigger factors for~     Hashimoto's thyroiditis and Graves' disease.~   "
58668|NCT02798952|"~     The purpose of this study is to assess the long-term persistence of immunity to hepatitis B~     in adolescents aged 14-15 years who were vaccinated with four doses of Infanrix™-Hexa in the~     first two years of life and to assess the anamnestic response, immunogenicity, safety and~     reactogenicity of a single challenge dose of the hepatitis B vaccine Engerix™-B Kinder.~   "
58669|NCT02798939|"~     Bacterial infections are a major cause of mortality in cirrhotic patients in the context of~     gastrointestinal bleeding or spontaneous bacterial peritonitis (SBP). Rapid diagnosis of SBP~     is therefore an important research goal because the gold standard neutrophil count in ascitic~     fluid cannot be performed 24 hours a day in all healthcare structures. The use of urine~     dipsticks in ascites cannot be recommended at the present time due to their insufficient~     sensitivity with an unacceptable risk of false-negatives in the context of a fatal disease~     for which effective antibiotic therapy is available. Ascitic fluid lactoferrin assay has~     recently been demonstrated to be a very good diagnostic test for SBP. The investigators plan~     to conduct a prospective study on lactoferrin as well as procalcitonin (PCT) to determine the~     best laboratory test(s) for the rapid, automated diagnosis of SBP. These tests will be~     compared with the Aution® urine dipstick, which has been shown to present better diagnostic~     sensitivity than the Multistix® dipstick . This single-centre study (Amiens University~     Hospital) will be performed in the context of routine clinical practice on ascitic fluid that~     is usually incinerated.~   "
58670|NCT02798926|"~     Particular attention is paid to thermal management of preterm neonates in neonatal intensive~     care units because of the major risk of morbidity associated with hypothermia. Percutaneous~     central venous catheter placement is essential to ensure adequate caloric intake and~     intravenous administration of treatments, but this procedure can cause major body temperature~     variations, responsible for complications in these neonates, as convection incubator function~     is impaired during opening of the incubator, which can be prolonged (30 minutes to 2 hours)~     depending on the technical difficulties encountered during catheter placement.~      In parallel, the use of a polyethylene bag or sheet in the delivery room and for neonatal~     transport is now clearly defined and ensures stability or even a considerable temperature~     gain during transfer immediately after birth. In the light of several clinical cases, the use~     of a polyethylene bag during central venous catheter placement appears to be effective to~     prevent body temperature loss in preterm neonates. No data are currently available concerning~     the value of this method of prevention of hypothermia during this type of procedure.~      Preliminary studies conducted by our team on a dummy suggest that a polyethylene bag or sheet~     could be useful during this procedure by significantly reducing heat loss caused by~     convection and evaporation. However, compensation phenomena such as generalized~     vasoconstriction to cold in preterm infants are very poorly described, but can induce a~     functional conflict between mechanisms ensuring maintenance of homeostasis and those involved~     in maintenance of blood pressure.~   "
58671|NCT02798913|"~     The objective of the present study was to evaluate the prognostic impact of prolonged dual~     antiplatelet therapy (DAPT) with acetylsalicylic acid plus clopidogrel on the incidence of~     major adverse cardiovascular events and major adverse limb events after percutaneous lower~     extremity revascularization in patients with lower extremity peripheral arterial disease~     (LE-PAD).~   "
58672|NCT02798900|"~     The aim of this study is to evaluate the effect of a functional task-training program~     combined with therapeutic ultrasound on pain, strength, gait biomechanics and functionality~     in adults with hip osteoarthritis.~   "
58676|NCT02798848|"~     This pilot randomized controlled trial (RCT) will test the methodology for a full RCT of~     assistive technologies for children/young people with low vision/blindness. The investigators~     will recruit 40 students age 10-18 years in India and the UK, who will be randomised into two~     groups. Apple iPads will be the active intervention; the control arm will be the local~     standard low-vision aid care. Primary outcomes will be acceptance/usage and accessibility of~     the device and trial feasibility measures. Exploratory outcomes will be validated measures of~     vision-related quality of life for children/young people as well as validated measures of~     reading and educational outcomes. In addition, the investigators will carry out~     semistructured interviews with the participants and their teachers, and attempt to evaluate~     cost-effectiveness.~   "
58677|NCT02798835|"~     This study investigates single injection adductor canal block (ACB) with or without~     intravenous dexamethasone and adductor canal catheter for pain management of total knee~     arthroplasty. This is a non-inferiority trial seeking to determine whether single injection~     ACB with dexamethasone is no worse than a continuous catheter.~   "
58678|NCT02798822|"~     Posterior crossbite is a common clinical condition often associated with transverse maxillary~     deficiency and functional mandibular shift. This frequent malocclusion is not self-correcting~     and can lead to the development of craniofacial asymmetries and mandibular dysfunction.~      The aim of the current study was to evaluate maxillary and mandibular arch widths' response~     to RME when it is anchored to the upper second deciduous molars or to the upper first~     permanent molars and to create a decision-making protocol for RME therapy in mixed-dentition~     patients.~   "
58679|NCT02798809|"~     The aim of the study is to follow a group of preschool children from early permanent~     dentition to determine the prevalence and incidence of caries malocclusions and to~     investigated the related risk factors as age, gender, ethnic origin and non-nutritive sucking~     habits, breathing disturbances, allergies, Dietary habits, oral hygiene status and dental~     care.~   "
58680|NCT02798796|"~     The aim of this study is to evaluate the ability of MRI to select patients for conservative~     treatment of breast cancer. Participants: female, over 18 years with breast cancer, stages I,~     II and III candidates for conservative surgery will be randomly randomized to do MRI or not~     according mammary density.~   "
58681|NCT02798783|"~     People with the congenital anatomical malformation known as Enlarged Vestibular Aqueduct~     (EVA) may experience decline in hearing ability. This is an online registry to gather patient~     experiences with EVA, with the goal of providing future researchers with the information~     necessary to better evaluate and make recommendations for patients with EVA. Data will be~     obtained from volunteers who enroll and submit their information on a website,~     https://eva.uhhospitals.org, and a limited data set may be provided to researchers interested~     in analyzing repository data. The limited data set would not contain any identifiable~     information except for ages, dates such as date of diagnosis, or city/state of residence.~      EVA Research Project Website: http://rainbow.org/EVAResearch~      EVA Patient Registry Website: https://eva.uhhospitals.org~   "
58682|NCT02798770|"~     Ischemic stroke is the leading cause of acquired disability among adults, and one of the main~     causes of death. In Switzerland, the approved time window for stroke treatment with~     intravenous thrombolysis after symptom onset is 4.5 h. Even within the 4.5 h time-window,~     however, the benefit of treatment strongly decreases as time passes.~      Moreover, only around 10% patients receive thrombolytic treatment, since patients with stroke~     arrive too late to the hospital (prehospital delay). Despite efforts to educate the community~     on the symptom of stroke, prehospital delay did not decrease over time, and the reasons~     remain incompletely understood. Prehospital delay reduces the proportion of patients with~     ischemic stroke treated with thrombolysis, and reduces the odds of favorable outcome among~     the minority treated with thrombolysis.~      This prospective cohort study aims at understanding the causes of prehospital delay among~     patients with acute ischemic stroke. Trained study-nurses will interview, at the bedside,~     patients and proxies along a standardized questionnaire on prehospital delay. Avoiding~     modificables causes of prehospital delay may increase the thrombolysis rate and improve~     outcomes after stroke.~   "
58683|NCT02798757|"~     This is a phase IV study that will explore the mechanisms of action of a drug (dapagliflozin)~     that is already commercially available in the country where the study will be conducted~     (Greece). The drug will be used according to its approved clinical indications (as add-on~     treatment in patients failed to achieve glycemic targets on metformin monotherapy) and in the~     approved posology (10 mg/day). Additionally, although there is limited data on the~     coadministration of dapagliflozin with thiazides, the excellent safety profile of the drug~     even when it is used in combination with drugs that induce significant volume depletion (such~     as loop diuretics) suggests that, in properly selected patients, the possibility of important~     adverse events during the coadministration of dapagliflozin with chlorthalidone is very low.~     All patients will give written informed consent prior to their enrollment in the study. The~     study protocol will be approved by the scientific committee of the University Hospital of~     Ioannina.~   "
58684|NCT02798744|"~     The aim of this study is to investigate the cause for the discrepancy in predicted and~     observed weight loss with Empagliflozin (Jardiance™) by measuring appetite regulation.~      Major secondary objectives are to determine the effects of Empagliflozin (Jardiance™) on~     energy expenditure and change in total body weight and body composition.~      The primary outcome is change in appetite hormone concentrations (specifically total PYY)~     between baseline and 24 weeks: - this will be measured by sequential blood sampling during~     visits 1-5.~      Secondary outcomes, which are exploratory, are effect on appetite hormones (ghrelin and~     GLP-1), appetite perceptions, total body weight and fat and fat free mass, energy~     expenditure, appetite perception, physical activity and blood and urine biochemical~     parameters after Empagliflozin (Jardiance™) treatment for 24 weeks.~      The sample size for the study is 76 participants and the planned trial duration is 21 months,~     with participants receiving approximately 24 weeks of exposure to Empagliflozin (Jardiance™).~   "
58685|NCT02798731|"~     The aim of the study is to evaluate the impact of early microvascular disease assessed by~     coronary physiologic indices such as fractional flow reserve (FFR), coronary flow reserve~     (CFR), index of microvascular resistance (IMR) on future occurrence of cardiac allograft~     vasculopathy (CAV) in heart transplant recipients.~   "
70622|NCT02642575|"~     The aim of the study to evaluate Five-Dimensional Ultrasound in automated measurement of~     ovarian follicles with controlled ovarian stimulation in contrast to the conventional 2D~     ultrasound~   "
58686|NCT02798718|"~     Milk is the source of high-quality protein, calcium, and other vitamins and minerals.~     Epidemiologic studies have linked high consumption of milk with risk of metabolic syndrome,~     T2DM, hypertension and obesity, which are independent risk factors of cardiovascular disease.~     However, milk contains disaccharide lactose, which may cause gastrointestinal problems in~     those adults with poor digestion. Recent studies have shown that subjects with intolerance to~     lactose tend to reduce their consumption of milk. Actually, consumption of 12g lactose (240ml~     milk) per day produces negligible symptoms in lactose intolerant. Furthermore, a dairy-rich~     diet could improve lactose intolerance because of colonic adaption to it. Lactose~     maldigestion would not be a restricting factor in milk intake. In general, the undigested~     lactose will be fermented by colonic bacteria into hydrogen, carbon dioxide, and short-chain~     fatty acids (SCFA: acetate, propionate, and butyrate). The SCFAs may have beneficial effects~     on human glucose and lipid metabolism, and the lactose fermentation may change the intestinal~     flora profile. But there are few studies evaluating effect of milk intake on health of people~     with lactose malabsorption or intolerance.This trial intend to study the effect of whole milk~     on cardio-metabolic risk factors of healthy person with or without lactose maldigestion.~   "
58687|NCT02798705|"~     The aim of the study is to evaluate coronary flow reserve (CFR), index of microcirculatory~     resistance (IMR), and proportion of overt microvascular disease, defined as depressed CFR as~     well as elevated IMR in patients with cardiac amyloidosis. The second objective of this study~     is to compare results of non-invasive test including serum light chain amount, Doppler~     echocardiography with 2D strain, and cardiac perfusion MRI.~   "
58688|NCT02798692|"~     The objectives of this first-in-human is to evaluate the safety and the immunogenicity of~     three administrations of a bivalent vaccine candidate against human cytomegalovirus, at three~     different dose levels.~   "
58689|NCT02798679|"~     The purpose of this study is to determine whether pre-existing cardiac fibrosis is a~     predictor of cancer treatment-related cardiotoxicity.~   "
58690|NCT02798666|"~     Background and aims: The purpose of this study was to evaluate the effect of high intensity~     interval training (HIIT) on body composition, physical fitness, metabolic fitness and muscle~     histology in men with overweight or obesity compared to continuous aerobic training (CAT).~      Material and methods: 16 male participants with overweight/obesity (age range: 42 - 57 years,~     body mass index: 28 - 36 kg/m²) were randomized to HITT (n=8) or CAT (n=8). HIIT was composed~     of two sprint blocks of 10 minutes at ventilatory threshold (VT), within between a continuous~     block of 10 minutes, twice a week for 15 weeks. CAT was composed of three blocks of 10~     minutes continuous endurance training at VT. After 5 weeks, intensity was increased to 110%~     of VT. Changes in body composition, physical fitness (peakVO2 and anaerobic threshold (AT)),~     basal respiratory exchange ratio (bRER) and insulin sensitivity by oral glucose tolerance~     test were evaluated. Mitochondrial content was evaluated by transmission electron microscopy~     (TEM) in muscle biopsies.~   "
58691|NCT02798653|"~     This study is a randomized clinical trial to investigate the efficacy of different luteal~     phase support methods in patients with poor ovarian response undergoing IVF and~     intracytoplasmic sperm injection (ICSI) cycles.~      The study protocol is approved by the Ethics Committee (Institutional Review Board) of Royan~     institute. The study is conducted according to the Declaration of Helsinki for medical~     research. All participants provide informed consent after counseling for infertility~     treatments and routine IVF/ICSI programs.~   "
58692|NCT02798640|"~     The study will evaluate changes in transcutaneous oxygen tension (tcPO2,), and the inferred~     change in local cutaneous blood flow, in healthy subjects wearing a control and a 100%~     Celliant® fiber upper torso garment.~   "
58693|NCT02798627|"~     NS2359 attenuates the euphoria associated with cocaine use. In a manner parallel to cocaine,~     NS2359 blocks the reuptake of dopamine (DA), norepinephrine (NE), and serotonin (5HT) with~     nanomolar affinities at the 3 transporters. In primates NS2359 significantly attenuated~     cocaine self-administration. In several phase II clinical trials for major depressive~     disorder and adult attention deficit disorder, NS2359 did not cause euphoria. NS2359~     exhibited no abuse potential in a human laboratory study comparing NS2359 with amphetamine.~     In a phase I human laboratory interaction study, NS2359 showed no toxicity after 20 or 40 mg~     of cocaine, but it attenuated the both the rewarding and cardiovascular effects of~     intravenous cocaine. On the basis of these promising studies, investigators propose a Phase~     II double-blind clinical trial of NS2359 in cocaine addiction (CA). The proposed trial will~     involve 100 CA subjects participating in an eight week trial, including a 1-week baseline and~     8 weeks of NS2359 or placebo treatment. Four weeks after completing the medication phase,~     there will be one follow-up visit. Subjects will be randomly assigned to treatment with~     placebo or 2 mg NS2359 daily, with a possible decrease to 1 mg daily for adverse events. This~     dose range is selected on the basis of phase I and II evidence of tolerability and NS2359~     plasma levels which were associated with blockade of cocaine reward. This project has the~     potential to identify the first effective pharmacotherapy for CA.~   "
58694|NCT02798614|"~     The purpose of this study is to compare the radiographic and clinical outcomes after short~     versus conventional plaster cast fixation time in reduced distal radius fractures.~   "
58695|NCT02798601|"~     The purpose of this study is to estimate the effect of an early induced hypernatremia~     protocol (150-155 milliequivalent/L) versus normonatremia plus mannitol (135 - 145~     milliequivalent/L) in terms of neurologic outcome in patients with severe traumatic brain~     injury managed at critical care unit.~   "
58696|NCT02798588|"~     In last decades, several advances in the neuro-intensive management have lead to decrease~     mortality in Intensive Care Units. A significant morbidity remains as patients survive after~     a traumatic coma with uncertain quality of awakening and a high risk of functional~     disability. Predicting awareness recovery and functional disability of those who will awake~     constitutes a major challenge to inform patients' relatives, to give the best chances in~     terms of rehabilitation resources or to adapt intensive cares to a reasonable level. Tools~     currently available are not sufficient neither to predict bad awakening outcome nor to~     predict good functional outcome. In many countries, life's support cessation is a constant~     call for robust evaluation as soon as possible in ICU but it is mandatory to reach a positive~     predictive value of non-awaking close to 100%. Many clinical, electro-physiological,~     biological, radiological and functional parameters have been conducted with comatose patients~     assuming the purpose to predict outcome. Regarding unfavourable outcome, the gold standard is~     the abolition of the N20 component of somatosensory evoked potentials but the specificity is~     high enough only for patients with anoxic coma. Several neurophysiological markers such as~     MMN, P300 are correlated to a favourable outcome but the sensitivity and specificity remains~     low for patients who suffered a severe traumatic brain injury. New Diffusion Tensor imaging~     sequences provide complementary information to detect small structural lesions (diffuse~     axonal lesions). Recently, functional MRI analyzing Resting State has also been proposed as a~     prognostic marker during coma. PET using Fluoro-Desoxy-Glucose is able to assess the~     metabolism in key regions of the awakening network in either anaesthesia or sleep. Recent~     studies have reported interesting results at the chronic stage but to knowledge, these tools~     have only been used to address pathophysiology's issues and never to improve coma prognosis~     at the initial stage. The investigators hypothesize that the heterogeneity of the population~     requires a global and accurate assessment of the central nervous system, combining~     structural, metabolic and functional information in order to refine the prognosis.~      The protocol integrates in one-sequence most radiological markers of brain injury within a~     unique PET-MRI in Lyon. The most relevant originality of the study consists in confronting~     FDG-PET and MRI sequences to a large clinical, electrophysiological and biological battery.~     The added clinical value would be to question the synergistic effect of each parameter and to~     find out which ones are the most useful for awakening prediction, as they have not been~     compared in a multi-parametric database.~      PET-MRI, as a new device combining physiological and prognostic questioning, allows us:~        -  to implement a more integrative physio-pathological analysis~        -  to avoid the cofounding effect of awareness' fluctuations in recording simultaneously~          multiple functional imaging techniques.~      The RS will be analyzed at 2 epochs in order to assess the stability of brain connectivity,~     related to neuronal activity (glucose metabolism) and brain perfusion.~   "
58697|NCT02798575|"~     Detecting exacerbations to prevent a severe and / or to early treat an exacerbation is~     crucial in patients with COPD in order to prevent hospitalization. Patients with invasive~     mechanical ventilation outside the hospital have a high re-hospitalization rate which is~     associated with severe economic burden since those patients need to be treated mainly on an~     ICU or a respiratory ward being able to take care of invasive mechanical ventilation.~      Recently, it has been shown that daily variations of parameters recorded by non-invasive~     ventilation (NIV) software are predictors of exacerbations in a cohort of COPD patients being~     treated outside the hospital with NIV [1]. These parameters were respiratory rate and~     percentage of respiratory cycles triggered by the patient.~      The aim of the present study is to detect parameters recorded by the ventilator which are~     able to predict exacerbation and / or hospitalization in patients with COPD under invasive~     mechanical ventilation outside the hospital.~   "
58698|NCT02798562|"~     The aim of this study is the clinical establishment of a native and contrast-enhanced~     computer tomography of the breast. The early detection of breast cancer is still a great~     challenge. Even though the implementation of the digital mammography combined with the~     mandatory screening-programs lead to significant improvements, sensitivity and specificity of~     these examinations need to be clearly classified as improvable. Generally, it is stated that~     the necessary transit from 2-D projected images to 3-D tomography will be crucially~     advantageous as magnetic resonance imaging has already shown. Similar or even major~     advantages can be expected by new approaches regarding CT with very high local resolution,~     better than 100µm in 3D and lower dose, under 5 Milligray (mGy), as demanded for a screening.~     A device that meets these demands and is also applicable for dynamic scans after intravenous~     administration of a contrast agent, has been developed with the support by the European Union~     (EU), German Research Foundation (DFG) and Federal Ministry of Education and Research (BMBF).~     Publications on technical and experimental results are already available. An evaluation in~     the clinical use is missing yet. The primary aim of this study is to evaluate systematically~     the performance of the native and dynamic, contrast-enhanced CT of the breast.~   "
58699|NCT02798549|"~     The emergence of hepatocellular carcinoma (HCC) has prompted a search for a thorough~     understanding of the biology of one of its major causative agents, the hepatitis B virus~     (HBV). HBV particles acquire via budding and encapsidation cellular proteins. There is~     mounting evidence on several viral species that virion-bound proteins are prone to be~     involved either at the replication, budding/egress or entry/release steps of the viral cycle.~      Identifying such targets may yield ideal candidates for gaining insight on the dependence of~     HBV upon a restricted subset of host proteins, therefore providing refined sets of~     genetically stable targets for therapy. This project's goals are to set up adequate~     conditions for robust and reproducible purification of HBV virions in clinical samples,~     followed by the identification of their HBV-bound host proteins and the characterization of~     their functions. Proteomics profiling of HBV particles purified from clinical samples will be~     overlaid with proteins identified and characterized in cell culture grown HBV particles,~     using clinical biomarker discovery grade criteria. Targets identified in both samples sets~     will be subjected to in vitro investigations using HBV-replicating cells. Conventional~     biochemical and imaging methods will be used in order to: (i) ascertain their physical~     association with HBV virions; (ii) define the modalities of their interaction with HBV~     proteins; (iii) decipher the topology and subcellular localization of their association with~     HBV proteins and virions; (iv) quantitatively assess their functional involvement in particle~     budding, egress or secretion and infectivity. A candidate that yielded satisfactory results~     in these experiments will be disclosed and further investigated at the level of structural~     biology, in collaborative research programs.~   "
58700|NCT02798536|"~     Background:~      LMB-100 is a man-made protein. It is attracted to the mesothelin protein. This is found in~     many tumors, including mesothelioma. But it is found in only a very small number of normal~     tissues. After binding to mesothelin on tumors, LMB-100 attacks and kills cancer cells.~     Researchers want to test LMB-100 in people with advanced mesothelioma.~      Objective:~      To find a safe dose and anti-tumor activity of LMB-100 for people with advanced mesothelioma.~      Eligibility:~      Adults ages 18 and older with:~      Advanced pleural or peritoneal mesothelioma that has not responded to platinum-based~      therapy~      Adequate organ function~      Design:~      Participants will be screened with:~      Samples of tumor tissue or tumor fluid. These can be new or from a previous procedure.~      Medical history~      Physical exam~      Blood, urine, and heart tests~      Chest x-rays~      CT or MRI scans~      FDG-PET scans~      Participants will get LMB-100 on days 1, 3, and 5 of each 21-day cycle. It will be given~     through an IV catheter, a tube inserted in an arm vein. They will get standard medicines~     before each infusion to help prevent side effects. Each infusion lasts about 30 minutes. They~     will be monitored for up to 2 hours after.~      During each cycle, participants will repeat the screening tests.~      Participants will get the study drug for up to 4 cycles or until their disease worsens or~     they have intolerable side effects.~      About 4 6 weeks after their last infusion, participants will have a follow-up visit. They~     will repeat the study tests.~      Participants will have follow-up scans every 6 weeks until their disease gets worse.~      Participants will be called about once a year to see how they are doing.~   "
58701|NCT02798523|"~     Background:~      The immune system defends the body against bacteria and other harmful invaders. But it can~     overact and attack healthy cells by mistake. The group of drugs called glucocorticoids (GCs)~     can calm down an overactive immune system. But they often cause negative side effects.~     Researchers want to learn how human genes respond to GCs. Genes live inside each cell of the~     body. They tell our cells how to function. Researchers hope the results of this study will~     show them how to develop better drugs that will have the benefits of GCs without the side~     effects.~      Objectives:~      To study how human genes respond to glucocorticoid drugs.~      Eligibility:~      Healthy adult volunteers ages 18 64.~      Design:~      Participants will be screened with a medical history and physical exam. They will have a~     heart test and blood tests.~      The study visit will last about 6 hours.~      Participants will have medical history, physical exam, and 3 blood draws.~      Participants will have a skin biopsy. An injection will numb the skin on one arm. Then a tool~     will remove a piece of skin about as big as a pencil eraser.~      A GC cream will be applied to the other arm.~      Participants will get the GC study drug for 30 minutes. It will be a liquid that will drip~     through a needle placed in an arm vein.~      Participants will have a skin biopsy of the arm that had the cream applied.~      Participants will have follow-up calls 1 and 4 days later. They will be asked about reactions~     or other health problems.~   "
58702|NCT02798510|"~     The present study is designed to determine whether adjuvant concurrent chemoradiotherapy~     improves overall survivals.~   "
58733|NCT02798107|"~     Idarucizumab is a humanized monoclonal antibody fragment (Fab) that binds to dabigatran with~     very high affinity. Idarucizumab potently and specifically binds to dabigatran and its~     metabolites and neutralises its anticoagulant effect. A clinical development program is~     ongoing to support marketing authorisation submissions for idarucizumab indicated in patients~     treated with dabigatran who require emergency surgery/urgent procedures or who have a~     life-threatening or uncontrolledbleeding when rapid reversal of the anticoagulant effects of~     dabigatran is required.~   "
58703|NCT02798497|"~     Staphylococcus aureus expresses a variety of virulence factors, including Panton Valentine~     leukocidin (PVL), a cytotoxin. PVL is specifically associated with primary skin and~     soft-tissue infections and severe necrotizing pneumonia (Gillet et al. Lancet,~     2002;359:753-9). PVL-positive S. aureus pneumonia is often preceded by influenza-like~     symptoms, and is mainly characterized by hemoptysis, pleural effusion, rapid onset of acute~     respiratory distress, leukopenia and a high fatality rate (65%) (Gillet et al. Lancet,~     2002;359:753-9). Ten year after the first description of this disease and a number of~     controversies in the scientific literature, the question arise as to whether PVL remains an~     independent factor of severity in S.aureus pneumonia. In addition, numerous questions remain~     unanswered yet; these are:~        -  (i) which factors, including treatment regimen, are associated with favourable outcome?,~        -  (ii) what is the susceptibility toward antibiotics of strains associated with this~          disease ?~        -  (iii) is there any genetic susceptibility of the host to explain both the rarity, and~          the explosive presentation of the disease ? To address the above questions a prospective~          observational study at the nationwide level will be set up. All French hospitals will be~          invited to describe the clinical features of all new cases of S. aureus~          community-acquired pneumonia with severity criteria, regardless PVL production. The~          study will include an investigation of a possible innate immune dysfunction in~          collaboration with the INSERM-U550 (Génétique Humaine des Maladies Infectieuses, Faculté~          Necker, Paris). Hence, in addition to collecting clinical and biological data from all~          pneumonia cases as well as all strains of S. aureus isolated, the patients with~          PVL-positive pneumonia will be sampled for immune genetic studies (ORFeome sequencing~          and functional studied)~   "
58704|NCT02798484|"~     Magnetic resonance imaging (MRI) is the method of choice in breast cancer to perform the~     loco-regional staging and direct the treatment.~      European Guidelines (EUSOMA) currently recommend MRI for initial evaluation and assessement~     of the neoadjuvant chemotherapy (NAC) response, for breast cancer. The standard of care~     consists of realizing a MRI before the start of the NAC and another one after it's ended, six~     months later.~      There is currently no consensus on the realization of an interval MRI for early assessment of~     the chemosensitivity of the tumor. It would allow though alterations in the therapeutic~     regimen in the event of a non response. Similarly, there is no consensus on when this~     interval MRI should be performed.~      Some recent studies suggest that Diffusion-weighted Magnetic Resonance Imaging is interesting~     for the evaluation of the early response. However, these are preliminary studies with~     quantitative measures realized by the region of interest (ROI) method. A response to~     neoadjuvant chemotherapy results in elevated values of apparent diffusion coefficients (ADC).~      The investigator's goal for this study is to evaluate the reliability of diffusion as tumor~     biomarker. Therefore, they will study the quantitative analysis of the diffusion-weighted~     magnetic resonance sequences in the pre-therapeutic assessment and the early and late~     follow-up of breast cancers under neoadjuvant treatment (chemotherapy, hormonotherapy...)~     within the CHU Brugmann hospital. The results of this analysis will be compared with the MRI~     results obtained at the end of the treatment and with the histology of the initial biopsy and~     the surgical specimen.~      The expected benefits are:~        -  to establish correlations between apparent diffusion coefficients (ADC) values and~          histology~        -  to observe changes in the ADC according to the type of response: ADC increase in the~          event of partial response, ADC stability in the event of non response, ADC decrease in~          the event of a progression, absence of restriction in the event of a complete response.~        -  to confirm that diffusion weighted MRI within a short interval (after one cure, at one~          month) has a predictive value for the neoadjuvant chemotherapy (NAC) response.~   "
58705|NCT02798471|"~     This is an event driven Phase 3, prospective, randomized, open-label, blinded endpoint~     evaluation (PROBE) parallel group study in subjects with confirmed VTE. This study is~     designed to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of edoxaban and to~     compare the efficacy and safety of edoxaban against standard of care in pediatric subjects~     with confirmed VTE.~   "
58706|NCT02798458|"~     Patients will undergo a SmartPill test to gain additional understanding of Fabry disease~     manifestation via motility abnormalities in order to improve symptom targeted therapy. An~     additional Endoscopic mucosal resection may be performed on further qualifying patients.~     Tissue analysis from this biopsy will include evaluation of abnormalities of cellular~     structure and morphology with correlation with gastrointestinal complaints for each patient~     and comparison against age matched non-Fabry patient tissue. The hypothesis is that patients~     with fabry disease will have abnormal motility which will correlate with the patients~     symptoms and quality of life as noted on the questionnaires.~   "
58707|NCT02798445|"~     The aim of this study is to determine the percentage of healing of active venous ulcers~     following Terminal Axial Perforator Interruption Reflux Source (tapirs technique) and~     adjustable compression system versus a control group using the traditional multilayer~     bandages.~   "
58708|NCT02798432|"~     Early total knee arthroplasty (TKA) implant systems most frequently used an all-polyethylene~     cemented tibial component1. Based on finite-element analysis studies reporting superior force~     distribution compared with conventional all-polyethylene components, metal-backed tibial~     baseplates have dominated the TKA implant market since the middle of the 1980's2. These~     modular implants provided excellent long-term implant survivorship3.~      As TKA became increasingly successful, younger patients increasingly became eligible.~     Increasing life expectancy has raised the concern that cemented TKAs may not withstand~     prolonged use, particularly in younger patients4. Patients younger than 65 years are~     projected to account for more than 50% of patients undergoing TKA by 2016 and to more than~     50% of patients undergoing revision surgery by 2011. The number of total knee revisions in~     the United States is expected to increase from 38,300 in 2005 to 268,200 in 20305.~      Many authors have reported excellent and equivalent results of cemented and cementless~     TKA6-8. Despite these encouraging reports, the major concern with cementless TKA has been the~     tibial component, and, therefore, the preference for many surgeons still remains to cement~     the tibial component9,10. The femoral component may be the most suitable for cementless~     fixation11-13. However, the best femoral method of fixation is still being discussed.~     Currently, the decision to cement or not to cement the femoral component is based on the~     surgeon's preference14.~      The current study was designed to compare the hybrid NexGen LPS (Zimmer Inc, Warsaw, IN) and~     the cemented NexGen LPS. The purpose of this study is to establish whether the hybrid NexGen~     LPS leads to equally successful results as the cemented TKA gold standard~   "
58709|NCT02798419|"~     DFD05 vs. Active01 in the treatment of common warts~   "
58710|NCT02798406|"~     Glioblastoma (GBM) and gliosarcoma (GS) are the most common and aggressive forms of malignant~     brain tumor in adults and can be resistant to conventional therapies. The purpose of this~     Phase II study is to evaluate how well a recurrent glioblastoma or gliosarcoma tumor responds~     to one injection of DNX-2401, a genetically modified oncolytic adenovirus, when delivered~     directly into the tumor followed by the administration of intravenous pembrolizumab (an~     immune checkpoint inhibitor) given every 3 weeks for up to 2 years or until disease~     progression.~      Funding Source-FDA OOPD~   "
58711|NCT02798393|"~     This is a double blind, randomized, placebo-controlled study in which a total of 120 patients~     will be selected from a broad spectrum group of typical Americans (all demographics including~     various races and both genders as well as ages from 25-90) who have confirmed Type 2 Diabetes~     Mellitus and suffer from mild to moderate lower extremity Peripheral Neuropathy. All patients~     will meet inclusion and/or exclusion criteria.~   "
58712|NCT02798380|"~     The purpose of this study is to assess the efficacy, safety and tolerability of HTS-519~     Inserts in the treatment of mild to moderate toenail fungus disease of the big toenail.~   "
58713|NCT02798367|"~     National clinical trials, phase III/II, combined in two stages, randomized, double-blind,~     controlled, parallel, study of superiority, in which two hundred fifty-six (256) participants~     of both sexes, aged equal or more than 55 years will be randomly allocated to one of three~     treatment groups. In the first stage. The group 01 will use Melatonin 3mg plus CBT-I, the~     group 02 will use Melatonin 5mg plus CBT-I and the group 03 will use CBT-I plus placebo.~      Based on the results of an interim analysis will be making a decision on whether to proceed~     with the study and, if so, on which the doses will be selected for the second stage of the~     study, to be better studied. The final analysis of the treatments, melatonin in the selected~     dose plus CBT-I versus CBT-I alone and placebo, will include participants from both stages.~   "
58714|NCT02798354|"~     The proposal will focus on 3 specific, high-risk, pediatric ambulatory diagnostic errors each~     representing a unique dimension of diagnostic assessment: evaluation of symptoms, evaluation~     of signs and follow-up of diagnostic tests. Adolescent depression (i.e. symptoms) affects~     nearly 10% of teenagers, is misdiagnosed in almost 75% of adolescents and causes significant~     morbidity. Pediatric elevated blood pressure (signs) is misdiagnosed in 74-87% of patients,~     often due to inaccurate application of blood pressure parameters that change based on age,~     gender and height. Actionable pediatric laboratory values (diagnostic tests) are potentially~     delayed up to 26% of the time in preliminary investigations and 7-65% in adults, leading to~     harm and malpractice claims.~      The investigators propose to conduct a multisite, prospective, stepped wedge cluster~     randomized trial testing a quality improvement collaborative (QIC) intervention within the~     American Academy of Pediatrics' Quality Improvement Innovation Networks (QuIIN) to reduce the~     incidence of pediatric primary care diagnostic errors. QuIIN is a national network of over~     300 primary care practices, ranging from tertiary care academic medical centers to single~     practitioner private practices, interested in and experienced with QICs. Because many~     processes are likely to be common across diagnostic errors in outpatient settings, a~     multifaceted intervention, such as a QIC, has a high likelihood of success and broad~     applicability across populations. Preparatory inquiries to QuIIN primary care providers~     suggest high interest in reducing these 3 diagnostic errors and provider agreement with~     randomization to evaluate diagnostic error interventions. Practices will be randomized to one~     of three groups, with each group collecting retrospective baseline data on one error above,~     and then intervening to reduce that error during the first eight months. Each group will~     concurrently collect control data on an error they are not intervening on during those eight~     months. Following those eight months, the groups will continue intervening on their first~     error, begin intervening on the error they were a control site for, and begin collecting data~     on the third error for which they will be a control site for. Finally, in the final eight~     months, all groups will intervene on all three errors. A second wave of practices will be~     recruited to join the groups after eight months and will only intervene on two of the three~     errors.~   "
58715|NCT02798341|"~     TRACR will provide a data/biospecimen repository for translational research to better~     diagnose, prognose, treat and cure breast cancer (and related diseases/treatment conditions).~     Patients at the Rowan Breast Center will be consented for donation of blood and if available~     tumor/healthy/archived tissue. Patients will be consented to give permission to use said~     specimens for future research and to be contacted in the future about other research~     participation and additional information.~   "
58716|NCT02798328|"~     Observational trial to evaluate the effectiveness of the TEG6s DOAC cartridge to detect and~     classify the presence of DOAC drugs in a subject.~   "
58717|NCT02798315|"~     The interferon-free combination regimen of Paritaprevir/r - Ombitasvir with or without~     Dasabuvir (ABBVIE REGIMEN) ± Ribavirin (RBV) for the treatment of chronic hepatitis C (CHC)~     has been shown to be safe and effective in randomized controlled clinical trials with strict~     inclusion and exclusion criteria under well controlled conditions.~      This observational study is the first effectiveness research examining the ABBVIE REGIMEN ±~     RBV, used according to local label, under real world conditions in Israel in a clinical~     practice patient population.~   "
58718|NCT02798302|"~     Healthy volunteers will participate in a crossover trial comparing preoxygenation with a~     non-rebreather mask to a bag-valve mask (with and without a simulated mask leak) at the flush~     rate of oxygen (fully opening standard oxygen flowmeter).~   "
58719|NCT02798289|"~     The primary objective of this study is to evaluate acute tear production as measured by tear~     meniscus height (TMH) captured by optical coherence tomography (OCT) after single use of the~     Oculeve Intranasal Neurostimulator (OIN) in participants with dry eye.~   "
58720|NCT02798276|"~     The purpose of this trial is to evaluate the efficacy of a pericardial adipose graft~     transposition (Adipose Graft Trasposition Procedure, AGTP) for the improvement of cardiac~     function in patients with a chronic myocardial infarction. Preclinical studies in the porcine~     model of myocardial infarction have shown that the AGTP reduces infarct area and improves~     cardiac function. A first-in-man clinical (NCT01473433) trial showed that the AGTP is safe in~     patients.~   "
58721|NCT02798263|"~     The pain is very common complaint, and the neck is one of the most affected spots, mainly due~     to muscle contracture of the cervical and scapular region, triggered by emotional stress~     associated with muscle retraction involved resulting from postoperative scarring or~     post-radiotherapy.O fear fibrosis move the limb and inactivity postoperative lead to gradual~     impairment of muscle strength and flexibility, and loss of ADM, which also predisposes to the~     appearance of pain.~      Goals Study the effectiveness of acupuncture in rehabilitation of physical and functional~     disorders of women undergoing surgery for breast cancer.~        1. Presence of pain by Visual Analog Scale of Pain (VAS).~        2. Shoulder Range of Motion (ROM) by active goniometry of flexion movements, extension,~          adduction, abduction, internal rotation and external rotation~        3. lymphedema presence through top member perimetry.~        4. upper limb function through the DASH questionnaire.~        5. Depressive symptoms through BECK questionnaire.~        6. Quality of life through the EORTC questionnaire.~        7. Muscle strength of flexion, extension, adduction, abduction, internal rotation and~          shoulder external rotation with the Hand Held Dynamometer 01,163 model of Lafayette~          Instrument Company.~      Patients will be divided into three randomized groups with 30 patients per group, who will~     receive weekly treatment for 10 weeks, and the group I treated with standard therapeutic~     exercise, pre-defined, based on stretching the neck muscles, shoulder girdle and exercises~     for ADM upper limb lasting 30 minutes; group II is treated com30 minutes classical~     acupuncture using pre-defined spots, and finally, grupoIII be used in the same acupuncture~     points of the group II, but using the Stiper® in place of the needles. If the patients in~     groups II and III still of pain at the end of 10 sessions will be treated complementarily~     with kinesiotherapy.~   "
58722|NCT02798250|"~     In previous studies, investigators have studied if a pre-meal insulin bolus based on~     estimated carbohydrate meal size would alleviate the burden of carbohydrate counting without~     a significant degradation in postprandial glucose control. With this strategy, the patient~     would only have to evaluate the size of the meal in terms of carbohydrate (snack, regular,~     large or very large). It is however important to establish the safety of this simplified meal~     bolus approach. The safety of overestimating a meal insulin bolus in the context of~     closed-loop strategy needs to be assessed. For ethical reasons, only dual-hormone closed-loop~     will be tested.~      Investigators hypothesize that dual-hormone closed-loop with overestimated meal size bolus~     will not increase time below 4.0 mmol/L compared to dual-hormone closed-loop with an~     adequately estimated meal size bolus.~   "
58734|NCT02798094|"~     The goal of this project is to learn more about the different ways in which people process~     information that is stressful and rewarding, and how abnormalities in these two processes are~     related to depression.~   "
58723|NCT02798237|"~     Physical activity level is an important determinant of quality of life in persons~     post-stroke. There is a lack of knowledge regarding the effects of aerobic training on~     physical activity levels in subjects post-stroke. Therefore, the primary objective will be to~     investigate the effects of aerobic treadmill training on physical activity levels and~     sedentary behavior in subjects post-stroke. The secondary aim will be to investigate the~     effects of the training on cardiorespiratory fitness, endurance, depression, mobility,~     quality of life, and participation.~      A randomized controlled trial with blinded assessment will assign eligible participants to~     either: 1) aerobic treadmill training (experimental group, at 60-80% of heart rate reserve),~     or 2) overground walking (control group, below 40% of heart rate reserve). Both groups will~     receive 40-minute training sessions three times/week over 12-weeks, in groups of 2-4~     participants, by a trained physiotherapist. Primary outcomes: physical activity levels and~     sedentary behavior (Multisensor SenseWear Mini® and Human Activity Profile). Secondary~     outcomes: cardiorespiratory fitness (peak oxygen uptake (VO2peak) and ventilatory threshold),~     endurance, depression, mobility, quality of life, and participation. The effects of the~     trainings will be analyzed from the collected data and intention-to-treat analysis.~     Between-groups differences will be measured by two-way ANOVA with repeated measures~     considering the baseline, post-training, and a 4-week follow-up.~      The results of this trial will likely provide valuable new information about the effects of~     aerobic treadmill training in improving physical activity levels and sedentary behavior,~     through changes in cardiorespiratory fitness, for individuals following stroke.~   "
58724|NCT02798224|"~     To compare patient perceptions, intent to screen, and screening use among those using a~     patient portal with and without a colorectal cancer (CRC) screening decision support tool,~     e-assist.~      To evaluate whether the effectiveness of e-assist is moderated by multi-level factors,~     including patient health literacy, decision-making preference, and CRC screening decision~     stage.~      To assess program impact and create an implementation guide for e-assist by combining results~     from Aims 1 & 2, a program implementation analysis/process evaluation and the perspectives of~     staff from future diverse implementation sites including small primary care practices,~     University-based primary practices and federally-qualified health centers.~   "
58725|NCT02798211|"~     To demonstrate that the efficacy of secukinumab 300 mg at Week 16 is superior to placebo in~     adult patients with active PsA based on the proportion of patients achieving an American~     College of Rheumatology 20 (ACR20) response.~   "
58726|NCT02798198|"~     Objective: The main target of this study was to research the early changes in pulmonary~     function and intrarenal hemodynamics, then research the correlation between the pulmonary~     function and the renal hemodynamics in type 2 diabetes (T2DM) patients without diabetic~     kidney disease (DKD).~      Method: 37 T2DM patients (diabetes group) without DKD and 33 healthy people (control group)~     were choosed to research early changes in pulmonary function and intrarenal hemodynamics,~     then research the correlation between the pulmonary function and the renal blood flow in T2DM~     patients, all having normal renal function. The primary endpoints were the pulmonary function~     parameters (VC%, FVC%, FEV1%, PEF%, MVV%, TLC%, FEV1/FVC%, DLCO%, and DLCO/VA%); the~     secondary endpoints were the intrarenal hemodynamic (bilateral kidney RI) in bilateral~     interlobular renal arteries were evaluated using; the tertiary endpoints were the biochemical~     variables: blood-fat (TC, HDL-C, LDL-C, and TG), renal function parameters (BUN, Cr, and~     GFR); in addition, the albumin excrete rate (AER), urinary albumin/creatinine ratio (UACR)~     were measured.~   "
58727|NCT02798185|"~     This is a study to develop methods of diagnosing chronic traumatic encephalopathy (CTE)~     during life, as well as to examine possible risk factors for this neurodegenerative disease.~     One component of this study is the use of an investigational PET scan radio tracer to detect~     abnormal tau protein in the brain.~   "
58728|NCT02798172|"~     Objective: To observe the effect of alogliptin combined with metformin on pulmonary function~     in obese patients with type 2 diabetes inadequately controlled by metformin monotherapy (500~     mg, bid po, for at least 3 months), and evaluate its efficacy and safety.~      Method: After a 2-week screening period, adult patients (aged 36-72 years) entered a 4-week~     run-in/stabilization period. Then, patients were randomly assigned to either the intervention~     group (n=55) or control group (n=50) for 26 weeks. The patients in the control group were~     given metformin (1,000 mg, bid po) and the patients in the intervention group were given~     metformin (500 mg, bid po) combined with alogliptin (25 mg, qd po). All the patients received~     counseling about diet and exercise from a nutritionist during run-in and treatment periods.~      The primary endpoints were the between-group differences in the changes pulmonary function~     parameters [VC%, FVC%, FEV1%, PEF%, MVV%, TLC%, FEV1/FVC%, DLCO%, and DLCO/VA%] between~     pretherapy and posttreatment. The secondary endpoints were changes from baseline to week 26~     in HbA1c, FPG, 2hPG, HOMA-IR, WC, and BMI. The tertiary endpoints were the changes from~     baseline to week 26 in blood-fat (TC, HDL-C, LDL-C, and TG). The quartus endpoints were the~     changes from baseline to week 26 in SBP and DBP. The fifth endpoints were the changes from~     baseline to week 26 in oxidative/antioxidative parameters (ROS, MDA, SOD, and GSH-PX). In~     addition, safety endpoints were assessed (AEs, clinical laboratory tests, vital signs, and~     electrocardiographic readings).~   "
58729|NCT02798159|"~     The purpose of this study is to identify the optimal dose(s) of TD0025 for treatment of~     erectile dysfunction (phase II) and to investigate if treatment of erectile dysfunction with~     the optimal dose of TD0025 taken as needed over one month is non-inferior than Sildenafil~     Citrate taken as needed over one month (phase III)~   "
58730|NCT02798146|"~     This pilot-study will help characterize the serum progesterone profiles in IVF patients and~     correlate progesterone levels to ovarian follicles obtained after stimulation with exogenous~     gonadotropins.~   "
58731|NCT02798133|"~     The aim of this study was to compare the effects of adding a recruitment maneuver (RM) to low~     tidal volume (VT) ventilation, with or without an individualized post-RM positive~     end-expiratory pressure (PEEP) setting in lung-healthy patients during anesthesia.~   "
58732|NCT02798120|"~     This is a multi-center, open label long-term safety (LTS) study to be conducted in~     approximately 600 subjects with acne vulgaris.~   "
58757|NCT02797795|"~     This study is a first-in-human, multicenter, open-label, nonrandomized, dose-escalation trial~     to be conducted in 2 sequential parts:~        -  Part A (Dose Escalation) in subjects with advanced malignancies~        -  Part B (Dose Confirmation) in subjects with tumor type(s) to be determined by results of~          Part A~   "
58735|NCT02798081|"~     A minimum of 23 people aged 60 years and older, of both sexes, from an informatics course for~     beginners will participate in the study. The evaluation will consist mainly in answering two~     validated questionnaires on socialization, the short Social and Emotional Loneliness Scale~     for Adults (SELSA-S) and short-form UCLA Loneliness Scale (ULS-6). Reaction time and~     performance will also be measured by three virtual reality games, namely Reaction Time,~     Random and Moviletrando. All this evaluation will be repeated in three moments: T0 - at~     baseline; T1 - after 8 conventional informatics classes and; T2 - after 8 informatics classes~     which includes 15 minutes for practicing virtual reality games.~   "
58736|NCT02798068|"~     Cardiac surgery is sometimes associated with organ dysfunction of variable severity (renal~     insufficiency, cognitive decline, arrhythmias, ARDS). The phenomenon responsible is an~     intense inflammatory reaction induced by cardiopulmonary bypass, leading to microcirculation~     alterations, specially in endothelial cell and its protective layer - glycocalyx. Endothelial~     dysfunction then reduces the reactivity of peripheral tissues to hypoxia, and is associated~     with bad prognosis.~      High - dose corticoids administration at anesthesia induction in cardiac surgery could~     attenuate the intensity of this inflammatory reaction, and represents the current practice in~     our hospital. Nevertheless, this attitude is abandoned in numerous cardiac surgery centres.~   "
58737|NCT02798055|"~     GRegistry is a significant collection of data and information on the clinical practice of~     systemic scleroderma finger ulcers.~      The GRegistry study is a nationwide (Greece) prospective study recording, which includes~     consecutive patients with SC-DU diagnosis in clinical management departments of different~     hospitals, selected in such a way as to reflect a representation of the country.~      The use of Bosentan in the treatment of patients suffering from systemic sclerosis with~     digital ulcer disease is supported by data from large, placebo-controlled, randomized~     studies. The beneficial effect of Bosentan in digital ulcers, a vascular event of systemic~     sclerosis consistent with its beneficial effect on pulmonary arterial hypertension associated~     with connective tissue disease and its beneficial effect on vascular remodeling.~   "
58738|NCT02798042|"~     Acute kidney injury (AKI) is a common, but significant complication after elective surgery~     which is associated with an increased risk of mortality, major adverse cardiac events,~     prolonged length of hospital stay, and increased cost per episode of care.~   "
58739|NCT02798029|"~     The goal of this clinical research study is to learn if a type of radiation therapy called~     frameless fractionated stereotactic radiation therapy (FFSRT) is effective for treating~     patients with brain metastases. The safety of this therapy will also be studied.~      This is an investigational study. FFSRT is delivered using FDA-approved and commercially~     available methods. The study doctor can explain how FFSRT is designed to work.~      Up to 35 participants will be enrolled in this study. All will take part at MD Anderson~     locations in Rio Rancho and Albuquerque, NM and the following Houston area locations in Bay~     Area, Katy, Sugarland, and The Woodlands.~   "
58740|NCT02798016|"~     Investigators will collect blood specimens from the participating patients and then blood~     samples will be centrifuged in order to collect platelet-rich plasma which is going to be~     injected in the atrophic acne scars. A split-face design is going to used in this randomized~     controlled trial. In the control side of the face, micro-needling to the skin will occur~     using a specific tool (Dermapen).~   "
58741|NCT02798003|"~     To study activity in the reward-circuitry of the brain in patients suffering from cachexia~     induced by cancer or chronic disease.~   "
58742|NCT02797990|"~     Qualitative project, comprising open-ended semi-structured interviews with healthcare~     workers, who provide antenatal care to substance-using women.~   "
58743|NCT02797977|"~     The purpose of this clinical study is to establish the safety profile, determine the maximum~     tolerated dose (MTD) and recommend a Phase 2 dose (RP2D) and schedule of SRA737 in~     combination with low dose gemcitabine; and to evaluate the efficacy of SRA737 in combination~     with low dose gemcitabine in prospectively-selected subjects with genetically-defined tumors~     that harbor genomic alterations linked to increased replication stress and that are~     hypothesized to be more sensitive to checkpoint kinase 1 (Chk1) inhibition via synthetic~     lethality. Specific cancer indications that frequently harbor these genetic mutations will be~     studied.~      Preclinical and clinical data support the hypothesis that active doses of SRA737 may be~     strongly potentiated by sub-therapeutic doses of gemcitabine, which should lead to clinical~     efficacy. To test this hypothesis, SRA737 in combination with low dose gemcitabine is being~     explored in this study.~   "
58744|NCT02797964|"~     The purpose of this clinical study is to establish the safety profile, determine the maximum~     tolerated dose (MTD) and recommend a Phase 2 dose and schedule of SRA737; and to evaluate the~     efficacy of SRA737 in prospectively-selected subjects with genetically-defined tumors that~     harbor genomic alterations linked to increased replication stress and that are hypothesized~     to be more sensitive to checkpoint kinase 1 (Chk1) inhibition via synthetic lethality.~     Specific cancer indications that frequently harbor these genetic mutations will be studied.~   "
58745|NCT02797951|"~     The main purpose of this study is to assess the long-term safety and tolerability of~     galcanezumab administered up to once monthly in participants with episodic or chronic cluster~     headache who have completed study I5Q-MC-CGAL (NCT02397473) or study I5Q-MC-CGAM~     (NCT02438826).~   "
58746|NCT02797938|"~     Endotracheal pressure with different cuff shapes can result in different cuff pressure change~     after head positional change. In this study, 52 patients underwent middle ear surgery with~     general anesthesia were randomly allocated to two group; patients were intubated with taper~     guard cuffed tube or cylindrical shaped cuffed tube. Anesthesia was maintained with~     sevoflurane with air/oxygen and remifentanil. The cuff pressure was initially set at 22~     centimeters of water in the neural head position and was measured after the change to the 45~     degree head rotation. The change of cuff pressure was compared between two groups~   "
58754|NCT02797834|"~     The main aim of this study is to describe the morphology, size distributions and specific~     markers of the different vesicles populations present in the human endometrial fluid. To~     further characterize the vesicles populations, contents of these membrane compartments (i.e.:~     DNA, RNA, proteins, lipids and other small metabolites) will be assessed by using mass~     spectrometry and next generation sequencing techniques. The objective here is to relate a~     specific vesicles composition to the moment of the cycle, to a normal physiological~     endometrial function and to the transmission of functionalities from the mother to the~     embryo.~   "
58747|NCT02797925|"~     There has been an increasing amount of musculoskeletal injuries the past decades and overused~     tendons represents a major problem both for leisure and occupational activities. A full~     understanding of the pathophysiology of tendinopathy is very sparse and especially the early~     events in tendinopathy remains unexplained. In this phd study the investigators will~     investigate early changes in tendon tissue overloading and development of tendinopathy. The~     investigators will investigate sports-active individuals with recently developed tendinopathy~     with regards to symptoms (pain, function), tendon morphology (ultrasonography, MRI and~     electron microscopy), tendon mechanical properties (ultrasonography strain), tissue molecular~     biology (expression and content of matrix proteins), inflammation (activity of inflammatory~     pathways) and vascularization (Doppler and contrast enhancement US). The investigators~     hypothesize a coupling between early symptoms and inflammatory activity, followed by~     structural changes and altered mechanical properties. The investigation will indicate what~     symptoms and what tendon related determined measurements are primary for disease development~     (tendinopathy blue prints) and should be regarding vital in prevention of tendinopathy.~   "
58748|NCT02797912|"~     In patients with cystic fibrosis (CF) the commonest cause of death is respiratory failure.~     Respiratory failure can have many causes. However, in patients with CF a major contributor is~     the impairment of the muscles required for breathing (respiratory muscles). Respiratory~     muscle impairment can result from poor nutrition. Lung function declines particularly during~     adolescence whilst body composition also changes at the same time. Thus, the investigators~     plan to study the relationship of nutrition and body composition to respiratory muscle~     strength and lung function in children and young people with CF aged between 12-18 years. The~     body mass index (BMI) is currently used in the clinical setting to measure nutritional status~     in CF. At King's College Hospital (KCH) there are portable devices to assess both respiratory~     muscle function and lung function. The research team will use a Bioelectrical Impedance~     Analysis (BIA) device to assess body composition, including BMI and lean body mass (LBM). The~     aim of the study is primarily to assess whether measurements of LBM impairment may better~     relate to poor lung function compared to BMI and secondly to examine whether lung and~     respiratory muscle function correlates with exercise tolerance.~   "
58749|NCT02797899|"~     Background: Free gingival graft (FGG) is used to increase keratinized tissue dimensions. This~     prospective clinical trial was conducted aiming to determine whether the addition of an~     autologous platelet-rich fibrin (PRF) would improve soft tissue healing of donor sites and~     decrease pain scores.~      Methods: Twenty four patients were planned to receive FGG to augment keratinized tissue~     dimensions in the mandibular incisors area. Donor sites were assigned randomly to receive PRF~     or not by a flip of a coin during the screening visit. Patients were instructed to complete a~     pain study form. The palatal donor area were evaluated for complete wound healing records.~     These data were assessed and recorded before surgery, and 1,2,3,4 and 8 weeks~     postoperatively.~   "
58750|NCT02797886|"~     The goal of the study is to explore the effect of combined training involving functional~     electrical stimulation (FES) of the ankle dorsal flexor with simultaneous maximal-effort~     voluntary contraction of the same muscle to correct or improve foot drop in chronic stroke~     patients. Participants will be assessed for functional motor ability and neurological~     function during their first visit and then again after five and then ten weeks of training.~     Functional motor ability is broken down into dorsiflexion strength and general gait analysis.~     Dorsiflexion strength is measured by use of a dynamometer. Gait is assessed via recordings of~     electromyography, pedobarography, kinematic, and various functional variables during 10~     walking trials. The neurological assessment will include electroencephalographic (EEG)~     analysis of movement-related cortical potentials (MRCP), somatosensory evoked potentials~     (SSEP), and M-wave response to stimulation. Participants will be randomly assigned to one of~     three groups: 1) FES + volitional movement (VOL), 2) FES alone, and 3) VOL alone, which will~     determine their training regimen. The training sessions involve roughly 20 minutes of~     repeated muscle contractions (with appropriate breaks to avoid fatigue). The participants~     assigned to the FES+VOL group will receive electrical stimulation to the peroneal nerve in~     concert with volitional dorsiflexion, whereas the other groups will either dorsiflex~     voluntarily with no stimulation or receive stimulation while being asked to do nothing.~   "
58751|NCT02797873|"~     The purpose of this study is to investigate how emotional and non-emotional regulation~     processes differ in EIP patients (with different levels of ADHD symptoms/ADHD-comorbidity)~     compared to controls. The investigators will test these participants' abilities to regulate~     emotional and non-emotional processes, reward anticipation and reward receipt while they~     undergo functional magnetic resonance imaging (fMRI). The participants' motor inhibition~     capacity on a behavioral level will also be investigated.~      The hypothesis is that EIP patients will present with more deficits in emotion regulation~     processes compared to controls, even when controlling for ADHD symptoms. It is also~     hypothesized that higher levels of ADHD symptoms will correlate with dysfunctional~     non-emotional regulation processes, on a behavioral as well as brain mechanistic level.~   "
58752|NCT02797860|"~     Pregnancy is associated with major changes of the body's physiological status and~     composition.~      These changes may modify the pharmacologic and/or pharmacokinetic profile of some drugs.~     Pharmacodynamic and pharmacokinetic changes in the 1st trimester during pregnancy are~     attributed to the following factors; Increase in plasma volume, heart rate and cardiac~     output; decrease in blood pressure due to decrease of systemic resistance and relative~     decrease of hepatic circulation and the aggravation of hepatic dysfunction. These changes~     intensify as pregnancy progresses into the 3rd trimester and take their effect on the onset~     time and duration of muscle relaxants.~      Rocuronium and the steroidal non-depolarizing muscle relaxant like vecuronium is mostly~     excreted with bile by hepatic metabolism and classified as the FDA pregnancy category B, and~     is widely used in general anesthesia of pregnant women. Previous studies reported onset time~     of rocuronium is affected by cardiac output, blood circulation time of the whole body, and~     muscle perfusion. Accordingly, many researches were conducted under the assumption of onset~     time and duration being affected by physiologic changes during pregnancy. For example, in the~     research where vecuronium was used as muscle relaxant for pregnant woman undergoing C-sec,~     onset of vecuronium was significantly shorter than that of the control group and duration was~     longer. In a study investigating rocuronium used for patients right after delivery, onset~     time was shorter and duration was longer than that of the control group.~      However, previous research mostly focused on the 3rd trimester, while there have been only a~     few studies of onset time and duration of rocuronium in non-obstetric surgery such as the~     transabdominal cervicoisthmic cerclage (TCIC) or Mcdonald surgery which are performed under~     general anesthesia during 2nd trimester. In this research, onset time and duration of~     rocuronium, which is widely used for general anesthesia in 2nd trimester pregnant females,~     will be compared with those of patients in the control group.~   "
58753|NCT02797847|"~     The purpose of this study is to determine the safety, tolerability, pharmacokinetics and~     pharmacodynamics of ALN-TTRSC02 in healthy subjects.~   "
58755|NCT02797821|"~     The purpose of this study is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD)~     of asfotase alfa in adult patients with pediatric-onset HPP.~   "
58758|NCT02797782|"~     More than two billion individuals have serological evidence of hepatitis B virus (HBV)~     infection worldwide. Of these, 240 million are chronic carriers and approximately 786,000~     hepatitis B related deaths occur annually.~      Currently available hepatitis B vaccines are extremely safe and have an efficacy of >90~     percent against all HBV serotypes and genotypes. Thus, HBV infection can potentially be~     eradicated through global vaccination. A positive immune response to the vaccine is defined~     as the development of hepatitis B surface antibody (anti-HBs) at a titer of >10 mIU/mL.~      Although anti-HBs titers decrease with time, the duration of protection is long. Protection~     has been estimated to persist for up to 22 years after the primary vaccination schedule.~     Protection from clinical disease, despite declining or even undetectable anti-HBs levels, is~     probably due to the priming of memory cells, which are capable of eliciting an anamnestic~     response when challenged. This is supported by the rapid increases in anti-HBs titers in~     previously vaccinated individuals who administered booster injections.~   "
58759|NCT02797769|"~     This retrospective cohort study will analyze data from multiple large U.S. health insurance~     claims databases to compare use of tocilizumab to other biologic disease-modifying~     anti-rheumatic drugs (DMARDs) in real world patients with RA. Using the date of dispensing as~     the index date, the analysis will compute the time to first event for several cardiovascular~     outcomes.~   "
58760|NCT02797756|"~     Using an active cohort of children in whom Airway and gastrointestinal endoscopy will be~     performed, investigators will conduct a chart review to obtain relevant clinical data and the~     investigators will use an aliquot of airway sample obtained during the clinically indicated~     bronchoscopy for microbiome analysis. A case-control study design will be used to study~     whether subjects with CC with GER have a distinct lung microbiome and increased inflammation~     as compared with subjects with CC without GER and to determine whether the microbiome and~     degree of inflammation is related to the type of GER (acidic versus nonacidic).~   "
58761|NCT02797743|"~     This study will obtain whole blood specimens from healthy subjects to be used for research~     and development and clinical validation of genetic assays.~   "
58762|NCT02797730|"~     Diagnostic of diabetes in childhood brought modification of family way of life, particularly~     in child and caregivers lifes.~      The education patient programs are in France centered on curative competencies of care.~      It is possible that art-therapy improve psycho-social competencies The aim of the study is to~     evaluate art-therapy sessions on quality of life of caregivers~   "
58763|NCT02797717|"~     Reduction of the indication for radiotherapy (RT) in newly diagnosed patients with classical~     Hodgkins lymphoma without compromising cure rates. Investigation of a chemotherapy~     intensification randomisation in intermediate and advanced classical Hodgkins lymphoma~     patients to compensate for reduction in RT.~   "
58764|NCT02797704|"~     The goal of this current study is to prospectively evaluate the influence of a single~     subconjunctival aflibercept injection on the regression of corneal neovascularization. Twenty~     patients with corneal neovascularization who are candidates for anti VEGF treatment (by the~     discretion of a corneal specialist) will be included in this study. The patients will be~     treated with a single subconjunctival injection of 0.08 ml aflibercept (25 mg/ml) in a single~     quarter of the conjunctiva, near the limbus in a proximity to the area of pathological~     neovascularization. Regression of neovascularization will be documented.~   "
58765|NCT02797691|"~     CBT for common mental disorders has a strong evidence base in both the USA and the UK. There~     are wider cultural and linguistic differences between Non Pashtun and Pashtun population of~     Pakistan and Afghanistan and there is evidence from research to suggest that CBT might need~     some adaptations when working with clients from non-western background. This study, thus,~     aims to culturally adapt CBT for common mental disorders for Pashto speaking population in~     Pakistan and Afghanistan and to test the effectiveness of this adapted CBT through a small~     scale pilot study.~      The study will be carried out using mixed methods; quantitative and qualitative. Qualitative~     part will consist of structured interview with a minimum of 10-15 patients; carers; and~     mental health professionals, respectively, using the interview questionnaires. The data will~     be analysed by systematic content and question analysis which will identify the emerging~     themes and categories. The data will then be reorganized into wider themes and categories and~     written for guidelines to culturally adapt therapy manual for common mental disorders.~      Quantitative phase will be a RCT involving 40 patients (20 in each arm) to assess the~     effectiveness of a CaCBT intervention for Pashto speaking patients. All those who fulfill~     the diagnostic criteria of depressive episode or recurrent depressive disorder using ICD 10~     RDC, are living near or can easily travel to the psychiatry departments in Peshawar, will be~     included in the study.~      The intervention group of the RCT will receive CaCBT intervention in addition to the~     treatment as usual (TAU) while the control group receives TAU. The assessment will be carried~     out at base-line and at the end of therapy (8-12 weeks). Bradford Somatic Inventory (BSI),~     Hospital Anxiety and Depression Scale (HADS) and Brief Disability Questionnaire (BDQ)/ WHO~     DAS will be used to measure somatic symptoms, anxiety, depression and disability due to~     physical and psychological problems, respectively. Schwartz Outcome Scale will be used at~     follow up to measure the outcome.~   "
58766|NCT02797665|"~     This study evaluates corticosteroids in the treatment of obstructive jaundice in autoimmune~     pancreatitis and/or immunoglobulin G4 (IgG4)-related sclerosing cholangitis in adults. Half~     of participants will receive corticosteroids alone, while the other half will receive~     corticosteroids with biliary stent at the beginning.~   "
58767|NCT02797652|"~     Our study aims to evaluate the possibility of clinical application of CTDNA detection in~     samples or peripheral blood of breast cancer patients, so as to act as the new techniques or~     indicators of early diagnosis, therapy efficiency, or postoperative surveillance of breast~     cancer.~   "
58768|NCT02797639|"~     Objective: Developing and corroborating the Collaborative Consultation for Participation of~     Students with Intellectual Disability (Co-PID) program, for enhancing classroom participation~     among students with moderate Intellectual and Developmental Disability (IDD).~      Method: study took place in two special education schools and included students with moderate~     IDD (n=60) and their teachers (n=11). The settings were randomly assigned to intervention or~     control group. In the intervention group, Co-PID program was employed; in the control group~     an In-Service (IS) was employed. Participation was evaluated at pre-test and post-test.~   "
58769|NCT02797626|"~     Primary objective:~      to evaluate progression-free survival in patients with clinical stage II A/B seminomatous~     germ cell tumor undergoing primary retroperitoneal lymph node dissection (RPLND) without~     adjuvant treatment~      Secondary objectives:~        -  overall survival~        -  perioperative complications (Clavien-Dindo score)~        -  quality of life (EORTC QLQ C30, EORTC QLQ TC26)~        -  long term sequelae~        -  rate of retrograde ejaculation~   "
59272|NCT02791035|"~     The purpose of this study is to examine the correlation between change of HbA1c, urinary~     glucose excretion and other factors when ipragliflozin is added to preexisting therapy in~     subjects with type 2 diabetes.~   "
58770|NCT02797613|"~     Asymptomatic bacteriuria (AB) is a condition in which bacteria are detected in urine culture~     without urinary symptoms. The inappropriate use of antibiotic treatment for AB selects~     bacterial flora to express resistance mutations. Reducing inappropriate antibiotic use for AB~     is difficult, since the microbiology laboratory cannot distinguish patients with AB. The~     investigators study will use a restricted laboratory report requesting the physician to call~     the laboratory for culture results. The restricted report may reduce the rate of~     inappropriate treatment of AB.~   "
58771|NCT02797600|"~     The study hypothesis is that the increased incidence of cervical cancer observed in~     Appalachian women over their non-Appalachian counterparts is due in part to inherited and~     somatic alterations of key components of the Transforming Growth Factor β (TGFβ) signaling~     pathway.~   "
58772|NCT02797587|"~     This study is a randomized controlled trial (RCT) to compare the effects of varenicline,~     cytisine, and nicotine replacement therapy (NRT) to reduce: 1) alcohol use and craving, 2)~     smoking; and 3) inflammation and risk for coronary heart disease (CHD) and mortality among~     400 HIV-infected Russians, with heavy alcohol consumption and tobacco use.~   "
58773|NCT02797574|"~     The purpose of this study is to investigate stress response pathways in tissues and~     melanocytes from patients with vitiligo. Investigators are collecting evidence of UPR and~     stress response activation in tissues and melanocytes from patients with vitiligo.~     Individuals with vitiligo will have punch biopsies to study stress response UPR activation~     and NF-κB signaling to test our hypothesis. In order to characterize differences between~     disease and normal states, a second arm of control individuals (Arm 2) will be recruited.~   "
58774|NCT02797561|"~     The purpose of this study is to evaluate the effect of FFR (Fractional flow reserve) guided~     Percutaneous Coronary Intervention in coronary tandem lesions.~   "
58775|NCT02797548|"~     The purpose of this study is to evaluate the safety and effectiveness of perioperative~     antiplatelet therapy in patients with drug-eluting stent undergoing non-cardiac surgery.~   "
58776|NCT02797535|"~     Up to 500 subjects undergoing standard endoscopy / pouchoscopy, or having ileostomy or~     colostomy bags or having an ileal pouch and who meet the eligibility criteria will be~     enrolled to this study during up to three years at up to 4 clinical sites. GI fluids samples~     will be collected from: (i) fluids suctioned during standard endoscopy procedures /~     pouchoscopy, (ii) from ileostomy/colostomy bags removed for bag replacement and (iii) from~     stool samples collected by patients after pouch surgery.~   "
58777|NCT02797522|"~     Normal healthy volunteers (NHVs) will enroll sequentially into a total of 6 escalating dose~     levels randomized to receive ARC-521 Injection or placebo.~      Hepatitis B e Antigen (HBeAg) negative Chronic Hepatitis B patients (CHBs) will enroll~     sequentially into a total of 3 dose levels to receive open-label ARC-521 Injection.~   "
58778|NCT02797509|"~     The current study has the following objectives:~        1. To determine additional stroke patient (SP) and stroke caregiver (SC) factors including~          their perceptions of the stroke experience, hospitalization, and how they cope with its~          challenges; identify additional appropriate points to intervene (maladaptive coping~          styles, unrealistic expectations, inappropriate prioritization, misinformation about~          illness, and self care), and assess SP and SC preferences for the structure, mode of~          delivery (including potential for phone, video or a combination of these) and timing of~          an intervention.~        2. To develop, [using the preliminary data and information from aim 1], and test the~          feasibility and acceptability (primary outcomes) of a skills-based intervention for~          preventing chronic depression, anxiety, PTSD and decreased QoL in dyads at risk.~   "
58779|NCT02797496|"~     Parkinson's disease is a major source of handicap, for which physical treatments are often~     underutilized with respect to chemical or surgical treatments. Yet, dopaminergic treatments~     alone prove unable to stop or control the gradual worsening of motor disability after a few~     years.~      The training program that this study sets out to evaluate aims to restore balance between~     agonist extensors and antagonist flexors in Parkinson's disease.~      There is indeed in Parkinson's disease an imbalance between weak flexors and weaker~     extensors, with excessive predominance of the flexors. The hypothesis of the study is that a~     motor strengthening program targeting extensor muscles specifically will improve body posture~     and restore motor function better than a conventional physical therapy program, in mild to~     moderate Parkinson's disease.~      This is a parallel-group, single blind, randomized trial (investigators will be kept unaware~     of the physical treatment followed by study subjects).~      The duration of patient participation is 5 months: 2-month intervention and 3-month follow-up~     following the intervention.~   "
58780|NCT02797483|"~     There is existing evidence to show that vegetable oils having unsaturated fatty acids in the~     sn-2 position with predominantly palmitic acid (C16:0) or stearic acid (C18:0) in the sn-1~     and sn-3 positions of fat molecules do not raise serum cholesterol levels. These observations~     have come to be known as or explained by the sn-2 hypothesis. New evidence have also~     emerged to show that saturated fatty acids (C16:0, C18:0) in the sn-1 and -3 positions~     reduces fat deposition in a rat model. Therefore, further studies in humans are warranted to~     confirm these earlier findings.~      Fats and oils are made up of >90% triacylglycerol (TAG)- fat molecules which consist of a~     glycerol backbone to which 3 esterified fatty acids are attached. The positions of fatty acid~     attachment are referred to by stereospecific numbers, sn -1, -2 and -3. Early evidence shown~     that the unique stereospecificity of fatty acid distribution on the palm fat molecule~     conferred health benefits in that it inhibited experimental atherosclerosis in the rabbit~     model.~      In vegetable oils, oleic acid [a monounsaturated fatty acid (MUFA)] is predominantly situated~     at the sn-2 position, while in animals fats it is predominantly palmitic acid or stearic acid~     (C16:0 or C18:0-saturated fat) that is situated there. Even though palm olein and lard have~     similar proportions of saturated fatty acid (SFA), MUFA and polyunsatuared fatty acid (PUFA),~     they differ significantly in their positional distribution on the TAG molecule. Palm olein~     TAG contains only 7-11 % palmitic acid at the sn-2 position while about 87% is unsaturated~     fatty acids (oleic acid and linoleic acid). Lard has the highest amount of palmitic acid in~     the sn-2 position at 70%. On the other hand, in human milk, palmitic acid is predominantly in~     sn-2 (53-57 %) while cow milk fat contains less palmitic acid (38 %) there. It is now~     believed that the distribution of fatty acids in the TAG is more important than the fatty~     acid composition alone in conferring the oils' 'saturated' or 'unsaturated' properties.~      In this proposed study, the effects on the outcome measures investigated of different fatty~     acids (palmitic acid, oleic acid, linoleic acid) at the sn-1, sn-2 and sn-3 positions of the~     TAG molecule in three different test fats will be investigated.~   "
58781|NCT02797470|"~     This phase I/II trial studies the side effects and best dose of gene therapy in treating~     patients with human immunodeficiency virus (HIV)-related lymphoma that did not respond to~     therapy or came back after an original response receiving stem cell transplant. In gene~     therapy, small stretches of deoxyribonucleic acid (DNA) called anti-HIV genes are~     introduced into the stem cells in the laboratory to make the gene therapy product used in~     this study. The type of anti-HIV genes and therapy in this study may make the patient's~     immune cells more resistant to HIV-1 and prevent new immune cells from getting infected with~     HIV-1.~   "
58782|NCT02797457|"~     The double amputation of the forearms is a rare handicap that seriously impacts the autonomy~     and the quality of life of patients, social and familial exclusion, and dependence on third~     parties for everyday activities.~      The management of these patients is nearly exclusively through the use of prostheses. Certain~     patients refuse this solution, or remain penalized by the absence of sensitivity , the lack~     of precision in movements, and body image issues related to the amputation; the double graft~     of hands and forearms may, in this circumstance, be the only solution.~      Since January 2000, date of the first double hand graft, six bilateral grafts of hands have~     been performed at the Hospices Civils de Lyon. This first study reported the feasibility of~     the graft. The functional results obtained after the double transplant have allowed patients~     to recover complete autonomy for everyday activities, at the price of an immunosuppressive~     treatment. We have found that these very good functional results are maintained over time~     and, for a certain number of patients, to return to work which is a factor of social~     integration.~      The rate of medical complications (metabolic, infectious, oncological), essentially related~     to the immunosuppressive treatment, is not greater to that found for other types of graft,~     but are considered as a limiting factor for the development of this strategy. These results~     are confirmed by international experience that is of the same order. Only a few rare cases of~     re-amputation have been reported in patients for whom the immunosuppressive treatment was~     discontinued or following vascular thrombosis.~      A new study is required to continue this evaluation and to compare double graft to prostheses~     in terms costs, quality of life, usefulness, satisfaction, autonomy, and social integration.~     The results of this study will allow the placement of these strategies in the management of~     patients with double amputation of the hands and forearms.~   "
58783|NCT02797444|"~     Advance Care Planning (ACP) is a process of 'reflection and communication, in which a person~     with decision-making capacity makes decisions regarding their future health and/or personal~     care in the event that they become incapable of consenting to or refusing treatment' Most~     Canadians have not planned for end-of-life Care and are at risk of aggressive medical care~     that may not be compatible with their wishes. This study aims to systematically evaluate~     local barriers to making personal choices with regards to life support interventions that can~     be provided in the contemporary Intensive Care Unit.~   "
58784|NCT02797431|"~     A multicenter, randomized, double-blinded, placebo-controlled study of two dosing frequencies~     of recombinant Interleukin-7 (CYT107) treatment to restore absolute lymphocyte counts in~     sepsis patients; IRIS-7A (Immune Reconstitution of Immunosuppressed Sepsis patients).~      A parallel study will be performed in United State of America to allow a common statistical~     analysis of the primary end points and analysis for the enrolled patient population.~   "
58785|NCT02797418|"~     Holders children with intellectual disabilities have great difficulty in adapting to social~     situations and relationships.Cognitive impairment associated with intellectual disability are~     important factors to understand their difficulties in processing social information. In the~     field of recognition of facial emotions in particular, basic cognitive processes such as~     visuospatial and attentional functions, are heavily involved.Cognitive remediation is a~     management tool widely used by practitioners to help patients who experience cognitive~     difficulties. Currently, no program can meet specific and validated the problems are children~     with intellectual disabilities manner in their daily functioning.~   "
58786|NCT02797405|"~     THEODORA is a prospective pilot clinical trial aiming at first to evaluate and validate the~     predictive value of the A & MS bioassays on tumor control by radiotherapy.~   "
58787|NCT02797392|"~     The continuously increasing prevalence of cardiovascular diseases, type-2 diabetes, and COPD~     is a major health problem in developed countries and is mainly caused by an unhealthy~     lifestyle. Most important lifestyle related causes of morbidity and mortality are smoking,~     obesity and physical inactivity, and increasing rates of obesity and physical inactivity in~     combination with smoking will lead to an increase in the number of patients with lifestyle~     related diseases in the coming decades. There is, therefore, an urgent need to identify and~     establish strategies and to implement interventions, allowing for the identification and~     management of citizens at increased risk of disease.~      Two recent systematic reviews of general practice based health checks suggest that people at~     increased risk of a chronic disease may benefit from a targeted approach to health checks.~     Targeted or selective preventive actions are a generally accepted and well integrated part of~     the health care system (e.g. treatment of hypertension and hyperlipidemia). However,~     selective prevention is challenged in terms of how to identify citizens at increased risk of~     disease in the general population in order to start the indicated preventive actions.~      The aim of the present pilot study is to test the acceptability, feasibility and short-term~     effect of a selective preventive program that systematically helps citizens evaluate~     individual risk of lifestyle related disease and offers targeted and coordinated preventive~     services in the primary health care sector.~      The intervention comprises four elements: 1) Systematic collection of information on~     lifestyle risk factors using questionnaire 2) Risk estimation and stratification into risk~     groups based on questionnaire data and information from the electronic patient record (EPR)~     using validated risk estimation models, 3) An individual electronic health profile with~     personalized advise on lifestyle change and 4) targeted preventive services at the general~     practitioner (GP) or the municipality for citizens at risk of lifestyle disease and citizens~     with risk behavior, respectively.~      The intervention is supported by a patient-centered health information system that~     facilitates informed patient action and integrates general practice and municipality health~     care providers.~   "
58788|NCT02797379|"~     The purpose of this pilot intervention trial is to assess the efficacy of newly developed~     psychoeducation guides designed to manage anxiety in Autism Spectrum Disorder (ASD) by~     recruiting 30 participants with ASD and high levels of anxiety along with their~     parent/caregivers who both receive a version of the psychoeducation guide.~   "
58789|NCT02797366|"~     Open label, multi-centre prospective study. Adult patients with primary central nervous~     system tumours fulfilling the inclusion criteria according to the study protocol. The study~     consists of 2 sequential cohorts evaluated consecutively for the feasibility, safety and~     toxicity, as well as long-term survival data, when using spot scanning proton beam therapy.~   "
58790|NCT02797353|"~     The Maternal Neonatal and Child health indicators in District Dadu of Pakistan portrays a~     dismal pictures and after the floods of 2010-2011 the health infrastructure of this district~     was badly affected. Aga Khan University Pakistan is intending to implement a service delivery~     project for the improvement of Maternal Neonatal and Child health situation through evidence~     based MNCH interventions.~   "
58791|NCT02797340|"~     The study evaluates the pharmacokinetics of metformin in heart failure patients in acute and~     chronic state in relation to metformin transporter genotypes. Participants have heart failure~     and type 2 diabetes treated with metformin.~      Hypothesis:~      Primary: The renal clearance of metformin is decreased in acute state of congestive heart~     failure compared with chronic state.~      Secondary: Metformin trough values in HF patients are influenced by polymorphisms in~     transporter genes relevant to the pharmacokinetics of metformin.~   "
58792|NCT02797327|"~     The primary goal of the study is to identify biomarkers from the molecular signature~     predictive of pre-term birth. This will be achieved through high frequency sampling and~     profiling throughout pregnancy.~   "
58814|NCT02797041|"~     This observational, non-interventional, retrospective, multicenter, national study focuses on~     collecting information about the effectiveness and safety of bortezomib re-use at first~     relapse in MM patients already treated in their first line with a bortezomib-based regimen,~     re-challenged with the same drug according to current clinical practice and/or Italian~     SIE/SIES/GITMO, IMWG and/or NCCN Guidelines/Treatment Recommendations.~      Data will be collected retrospectively from approximately 25 haematologic/oncologic sites in~     Italy. Approximately, data of up to 100 patients will be collected.~   "
58793|NCT02797314|"~     Patients with type 2 diabetes have many complications in different organs. These~     complications are extremely frequent and severe: cardiovascular and renal disease, visual~     impairment, and, more recently, complications affecting bone such as fractures. Conventional~     methods for the evaluation of fracture risk are based on the Bone Mineral Density (BMD) or~     FRAX (algorithm for the prediction of osteoporotic fracture risk) are not sufficient in the~     context of diabetes. Several metaanalyses have shown that, paradoxically, a higher BMD in~     patients with type 2 diabetes compared to patients not suffering from this disease,~     independently of body mass index (BMI). The paradoxal increase in fracture risk, despite a~     high BMD has led to the hypothesis that diabetes induces a modification of the quality and~     not the quantity of bone. However, there is a lack of data as to bone quality in patients~     with type 2 diabetes as studies of bone biopsies from patients with type 2 diabetes are~     extremely rare.~      The objective of the study is to compare bone quality in patients with type 2 diabetes to~     that in patients who do not suffer from type 2 diabetes: evaluation of vertebral fractures by~     osteodensitometry, measurement of Trabecular Bone Score (TBS), and analysis of bone quality~     in biopsies (advanced glycation end products (AGE), contents of bone matrix and analysis of~     mineralization).~      The results will then be correlated with blood/urinary markers with the objective to~     determine one/several non-invasive biomarkers for bone status in diabetic patients.~   "
58794|NCT02797301|"~     This study was to develop a computerised test with an adapted peripheral to assess the~     emerging literacy knowledge of children with mobility difficulties. The software was~     implemented using a game-like design controllable by a peripheral device without needing fine~     movements.~   "
58795|NCT02797288|"~     The protocol aims to address the basic mechanisms of Clostridium difficile pathogenesis by~     identifying how Clostridium difficile toxins inhibit eosinophils that otherwise would protect~     the gut from damage. This could lead to new and effective approaches to the treatment or~     prevention of Clostridium difficile colitis that act downstream of fecal microbiota~     transplants (FMT) or next generation probiotics. Successful fecal transplantation will~     restore Interleukin-25, Interleukin-4 and eosinophils to the colon~   "
58796|NCT02797275|"~     Exposure to secondhand tobacco smoke (SHS) is associated with diverse health effects in~     nonsmokers. Flight attendants who worked on commercial aircraft before the ban on tobacco~     smoking (exposed FAs) had high, long-term levels of occupational exposure to SHS and are a~     unique population for the study of long-term health effects of chronic exposure to SHS.~      In previous studies, we have shown that many never-smoking SHS-exposed FAs to have~     curvilinear flow-volume loops, decreased airflow at mid- and low-lung volumes, and static air~     trapping (elevated residual volume to total lung capacity ratio [RV/TLC]), abnormalities that~     are not diagnostic of overt COPD, but do implicate the presence of an obstructive ventilatory~     defect, and are consistent with what has been recently described as preserved ratio impaired~     spirometry (PRISm).~      The main objective of the study is to determine the effect of a bronchodilator to counter the~     physiologic abnormalities that are observed in the population of never-smoking SHS-exposed~     FAs as both proof of concept of the presence of an obstructive lung disease and as a possible~     therapeutic option to counteract the adverse respiratory effects of chronic exposure to SHS.~   "
58797|NCT02797262|"~     Introduction of antiretroviral therapy (ART) has transformed HIV-infection from a fatal to~     manageable disease but adherence to ART remains critical to optimize outcomes. Existing~     measures of ART adherence provide only inferred measures of actual drug intake and most offer~     no real-time notification capability. Directly observed therapy measures actual drug intake~     but is not practical. These limitations constrain research into medication adherence and more~     importantly, limit our ability to develop real-time interventions based on feasible, in vivo~     monitoring of adherence among HIV-infected people to facilitate medication-taking. The~     Proteus digital health feedback (PDHF) system, a pill ingestible sensor based adherence~     measuring and monitoring system developed by Proteus Digital Health, addresses these~     limitations. It involves use of an ingestible sensor, a tiny edible material that is~     over-encapsulated along with prescribed medication. The sensor is activated by ingestion and~     is sensed by a patch worn by the patient with an embedded monitor and sensor. The monitor~     sends a Bluetooth signal to a mobile device, which in turn sends an encrypted message to a~     central server, thus effecting real-time monitoring that a dose has been taken. The~     investigators propose to develop a data receiving hub and add to these components an~     automated text message that is sent to the patient when a dose is missed. The investigators~     will evaluate the feasibility, acceptability and sustainability of using the PDHF system;~     assess the accuracy of the PDHF system in measuring adherence to ART; and evaluate the~     efficacy of the PDHF system for monitoring and leveraging adherence to ART.~   "
58798|NCT02797249|"~     Preeclampsia is one of the three leading causes of maternal morbidity and mortality all over~     the world. The use of low dose aspirin has been mentioned in several studies with promising~     results. The investigators decided to evaluate the use of low dose aspirin in Chinese~     pregnant women, starting between 12+ and 20 weeks of pregnancy, based on clinical~     characteristics aiming to reduce the incidence of preeclampsia.~   "
58799|NCT02797236|"~     This is a first-in-human, single-center, single-blinded, observer-masked randomized, dose~     escalation (two doses), placebo-controlled study in healthy volunteers.~   "
58800|NCT02797223|"~     The main objective of this qualitative phenomenological study is to understand the impact of~     chemotherapy-induced alopecia, the quality of life of women with breast cancer from this~     experience.~      The study will be conducted in the day hospital oncology-hematology of the Hospital de la~     Santa Creu i Sant Pau. Data collection will be done through semi-structured interviews. About~     12 to 14 interviews throughout the study was conducted. So in the study involved a total of~     between 12 and 14 women.~      These will be recorded in voice and then transcribe and code. From reading and re-reading the~     patterns or data that relate to each other, thus establishing the categories (thematic~     analysis) were identified. These categories describe the experiences of the participants~     alopecia.~   "
58801|NCT02797210|"~     This trial will compare the efficacy of active inhibitory OFC-rTMS to sham OFC-rTMS in major~     depression. The trial will include structural and functional MRI, EEG, and behavioral~     measures obtained before, during, and after treatment.~   "
58815|NCT02797028|"~     The purpose of this study is to confirm the protective effect and mechanism of anthocyanins~     on hyperuricemia patients with Cardiovascular disease.~   "
58802|NCT02797197|"~     Sarcopenia is defined as a loss in skeletal muscle mass and function (strength and/or~     performance). There is a high prevalence in elderly and in patients with cancer. Several~     mechanisms are known to explain sarcopenia (inflammation, neurodegenerative process, hormonal~     disorders, lack of exercise, malnutrition). The consequences were analysed in several studies~     where sarcopenia appeared to be an independent factor of mortality, and associated with~     cancer-related fatigue, nosocomial infections, cardio-vascular diseases, and chemotherapy~     toxicities.~      Diagnosis is based on the measure of the muscle mass performing an abdominal~     computed-tomography (CT) scan, and on the measure of the muscle strength using the handgrip~     test with a Jamar® hydraulic hand dynamometer. CT scan is more invasive and less easy to~     reach than handgrip test. This test is used to be performing in elderly but not in cancer~     patients having chemotherapy. Present prospective study explored the feasibility of~     systematic handgrip strength testing and short-term changes in muscle strength in digestive~     cancer patients treated by chemotherapy.~   "
58803|NCT02797184|"~     The purpose of this study is to do the work that is necessary and sufficient for setting up~     an appropriate multi-center, randomized clinical trial (RCT) of a new therapy for heart~     failure: inorganic nitrate. The investigators will first determine the effects and~     palatability of ~12.8mmol KNO3 (an oral pill) as compared to the roughly equivalent amount of~     nitrate in 2 beetroot juice (BRJ) Sports Shots (by James White Drinks). Next, the~     investigators will determine the effects of inorganic nitrate (KNO3 in an oral pill format)~     on blood pressure, blood nitrate levels, breath nitric oxide (NO) levels, and exercise~     performance in a dose-response study. Third, the investigators will perform a small phase II~     chronic treatment study that will allow them to determine the best primary endpoint and the~     numbers of patients the investigators will need to study in the large, multi-center RCT to~     follow this project. In the small study and in the RCT to follow, the investigators will~     determine whether inorganic nitrate can improve aerobic exercise capacity, muscle power, and~     speed of muscle contraction, and lessen the effort of breathing during exercise.~   "
58804|NCT02797171|"~     This study will evaluate the safety, pharmacokinetics, and antiviral activity of~     VRC-HIVMAB060-00-AB (VRC01) and VRC-HIVMAB080-00-AB (VRC01LS) in the serum and mucosa of~     healthy, HIV-uninfected adults.~   "
58805|NCT02797158|"~     Evaluation of a strategy of selected revascularization guided on myocardial ischemia~     detection after the TAVI procedure by using single photon emission computed tomography~     (SPECT) myocardial perfusion imaging.~   "
58806|NCT02797145|"~     Digoxin was approved for heart failure treatment in 1998 according to current regulations~     made by Food and Drug Administration (FDA), based on the following clinical trials: The~     Prospective and Randomized Study of Ventricular Function and Efficacy of Digoxin (PROVED),~     Randomized Assessment of Digoxin on Inhibitors of the Angiotensin Converting Enzyme~     (RADIANCE) and Digitalis Investigation Group (DIG). Also, it was approved for the control of~     ventricular response rate in atrial fibrillation patients.~      Several clinical trials with digoxin provided convincing evidence that support the digoxin~     use heart failure (HF) treatment of symptomatic patients. PROVED trial was a~     placebo-controlled, twelve weeks duration study. This study included patients with decreased~     systolic function, sinus rhythm and heart failure stable symptoms, these patients were using~     digoxin and diuretics. Patients whom digoxin was removed presented a twice heart failure~     worsen, reduction of exercise capacity and also a reduction of left ventricle ejection~     fraction, in comparison to patients that kept the digoxin therapy. The study RADIANCE~     followed a similar protocol; however the patients used ACE inhibitors besides digoxin and~     diuretics. The digoxin removal was associated with a six times worsen of heart failure,~     despite the maintenance of ACE inhibitors and diuretics. There was a worsening in the~     functional capacity, life quality and in the ejection fraction on the digoxin removal~     patients' group.~   "
58807|NCT02797132|"~     This is a Phase 3, 2-part (Part A and Part B), open-label, multicenter study evaluating the~     pharmacokinetics (PK), safety, tolerability, and pharmacodynamics (PD) of multiple doses of~     Lumacaftor/Ivacaftor (LUM/IVA) in subjects 2 through 5 years of age (inclusive) with Cystic~     Fibrosis (CF), homozygous for F508del. Subjects who participate in Part A may participate in~     Part B, if patient meet the eligibility criteria.~   "
58808|NCT02797119|"~     TRACES trial is a multicenter randomized double blind placebo control therapeutic and~     pharmaco-biological dose ranging study to measure the effect on blood loss reduction of a~     single intravenous infusion of two doses regimens (standard dose and low dose) of TA~     administered at the onset of an active PPH (>800mL) during elective or non-emergent CS and to~     correlate this clinical effect with the biological effect of fibrinolysis inhibition and the~     pharmacodynamic measure of TA uterine bleeding and venous blood concentration.~   "
58809|NCT02797106|"~     The study is a transversal, observational, descriptive survey of the practices and opinions~     of health professionals carried out nationally across France that aims to characterize~     children with cerebral palsy and pathological drooling and to describe care pathways,~     assessment and treatment of drooling.~   "
58810|NCT02797093|"~     The purpose of this study is to evaluate the relationship between anti-retroviral therapy~     (ART) adherence with levels of human immunodeficiency virus (HIV) reservoir and residual~     viremia in suppressed, HIV-infected individuals on chronic ART.~   "
58811|NCT02797080|"~     The purpose of this long term extension study is to evaluate the long-term safety of~     ACTIMMUNE® (interferon-γ 1b) in participants with Friedreich's Ataxia (FA).~   "
58812|NCT02797067|"~     The purpose of the study is to determine whether rectal indomethacin reduces the incidence of~     post-ESWL pancreatitis.~   "
58813|NCT02797054|"~     The purpose of this study is to evaluate an innovative approach to improving HPV vaccination~     among the Hispanic population. The objectives/aims of this HPV educational intervention~     project are:~        1. To measure the quality of the HPV vaccine decision among participants in different arms~          of the intervention~        2. To determine patterns of intervention utilization among participants in different arms~          of the intervention, and~      The implementation of this educational intervention in clinic waiting rooms is intended to~     assist primary care providers in communicating HPV vaccine awareness and education to parents~     and patients in a culturally tailored format.~   "
58816|NCT02797015|"~     The purpose of this study is to learn about the pharmacokinetics and pharmacodynamics of~     RPC1063 in RMS.~   "
58817|NCT02797002|"~     Neck pain (NP) is one of the most common and costly musculoskeletal complaints in today's~     societies. Cervical muscles endurance has been commonly associated with the development of~     NP. Real-time ultrasound imaging is a reliable and valid technique recently used by physical~     therapists to evaluate muscle structure, function and activation patterns. The aim of this~     study is if change in muscle thickness can correlate with the results of the endurance~     testing.~   "
58818|NCT02796989|"~     During this project the effect of modified wheat bran on colon health and systemic health~     will be evaluated in a long-term intervention study in healthy and obese subjects.~   "
58819|NCT02796976|"~     The aims of the study are twofold. In the cross-sectional approach (Part I), the study will~     be conducted in an older population to assess the association of physical fitness on~     different parts of the human vascular bed. In the interventional approach (Part II), it aims~     to investigate whether and to what extent advanced vascular ageing (AVA) in older subjects~     with increased cardiovascular risk can be reversed by regular walking- based high intensity~     interval training.~   "
58820|NCT02796963|"~     The purpose of this stepped wedge randomized controlled trial is to evaluate the~     effectiveness of a crowdsourced intervention on promoting HIV testing among young Chinese men~     who have sex with men (MSM). The crowdsourced intervention will include an open contest,~     judging to determine finalists and prizes, a designathon, and contest-based MSM engagement.~     The hypothesis is that a crowdsourced intervention will be superior to conventional HIV test~     uptake campaigns in eliciting HIV test uptake.~   "
58821|NCT02796950|"~     Glucagon like peptide 1 is produced in enteroendocrine L cells in the small intestine~     stimulated by peroral food intake. GLP-1 induces insulin secretion, and analogues are used in~     the treatment of DM2 (type 2 diabetes mellitus). Recently it was found, that levels of GLP-1~     are increased in response to acipimox. The hypothesis is that G protein coupled receptors on~     enteroendocrine L cells bind acipimox and thereby induce GLP-1 secretion.~      In a controlled, open, randomized experiment, eight healthy, overweight men will be studied~     on an intervention day, where they receive acipimox, and on a control day. The study day~     includes an OGTT (oral glucose tolerance test), blood samples before and after the OGTT and a~     biopsy from adipose tissue.~   "
58822|NCT02796937|"~     This is a 2-year open-label, multicenter extension of the double-blind, placebo-controlled~     GTi1201 study. The purpose of this study is to obtain an additional 2 years of safety data~     for intravenously administered Alpha1-MP 60 mg/kg/week in subjects with alpha1-antitrypsin~     deficiency (AATD).~   "
58823|NCT02796924|"~     The purpose of this study is to investigate the feasibility of using repetitive transcranial~     magnetic stimulation (rTMS) - a form of non-invasive brain stimulation - to decrease the~     frequency of psychogenic non-epileptic seizure (PNES) episodes in patients with PNES.~   "
58824|NCT02796911|"~     Objective: Periodontally accelerated osteogenic orthodontics(PAOO) will minimize treatment~     time. The current study will be carried to evaluate the effectiveness of different bone~     grafts with a modified, less invasive corticotomy technique in the treatment of adult~     patients with moderate crowding.~      Subjects and Methods: Thirty orthodontic patients will be selected. Patients were randomly~     classified into three groups. Group I will be treated with a modified technique of~     corticotomy, whereas group II will be treated with the same technique combined with PAOO~     using bovine derived xenograft, and group III will be treated with the same technique~     combined with PAOO using with bioactive glass. The total duration of active orthodontic~     treatment will be estimated. Probing depth, bone density and root length will be also~     evaluated. The measurements will be recorded.~   "
58825|NCT02796898|"~     The purpose of this study is to evaluate the safety, pharmacokinetics, and efficacy of SM88~     in patients with prostate cancer~   "
58826|NCT02796885|"~     Hypophosphatasia (HPP) is an inherited condition which causes a defect in bone calcification,~     leading to weak bones. Early childhood forms are severe and easily recognised, and there is~     now a drug treatment which is very effective in children.~      Adult forms are milder, often missed by doctors or confused with osteoporosis. This is~     important because the usual osteoporosis treatments may be harmful in HPP, and increase the~     risk of broken bones. One of the reasons it is missed is a lack of research describing the~     typical features of HPP, so doctors don't recognise the signs, and don't know when or how to~     test for it.~      The aim of this study is to establish clear criteria (from clinical history, examination and~     blood tests) to identify people with HPP. The results will also determine if there should be~     a trial of drug treatment for adults with HPP.~   "
58827|NCT02796872|"~     This survey is a multicenter, double-blind, randomized, controlled, parallel-designed,~     prospective trial and is intended to evaluate the Bimuno GOS effects on growth, tolerance,~     gut health, fecal flora and immune function.~   "
58828|NCT02796859|"~     This study is a Phase 1 clinical trial to determine the safety, tolerability, and efficacy of~     Siltuximab (Sylvant) as an adjunct to antipsychotic medications in stable outpatients with~     schizophrenia. Siltuximab (structural formula C6450H9932N1688O2016S50) is a recombinant~     chimeric (human-murine) anti-human interleukin-6 (IL-6) monoclonal antibody. Siltuximab is~     formulated as a concentrate for solution for infusion, and will be administered by~     intravenous infusion.~      The investigators propose a 9-week randomized controlled trial of siltuximab, given in~     adjunct to antipsychotics, in N=30 stable outpatients with schizophrenia or schizoaffective~     disorder and evidence of increased inflammation in the peripheral blood (high-sensitivity~     C-reactive protein [hsCRP] >0.5 mg/dL). The investigators hypothesize that adjunctive~     treatment with siltuximab will be associated with significant improvement in cognition~     compared to placebo in patients with schizophrenia, baseline IL-6 levels are higher in~     siltuximab-treated responders versus non-responders, and there will be greater decreases in~     hsCRP from baseline to week 6 in siltuximab-treated versus placebo-treated responders, with~     response defined as ≥0.5 SD improvement in cognition. Siltuximab is administered as an~     intravenous infusion every 3 weeks. Following a screening evaluation, participants will~     receive three infusions of siltuximab, one at baseline, another at week 3 of the study, and~     another at week 6. The investigators will measure changes in cognitive function and symptoms~     over a 9-week period. Complementing previous positive clinical trials of non-steroidal~     anti-inflammatory drugs, this would be a proof-of-concept study that targeting specific~     cytokines is a viable treatment for schizophrenia.~      Interleukin 6 and its receptor were discovered and cloned at Osaka University, Japan, by~     Tadamitsu Kishimoto in the 1980s. Janssen Pharmaceuticals, Inc. began the clinical~     development of siltuximab for the treatment of multicentric Castleman's disease, a rare blood~     disorder. Other clinical studies with siltuximab have been conduced for patients with B-cell~     non-Hodgkin's lymphoma, multiple myeloma, and ovarian cancer.~      In April 2014,siltuxiumab was approved by the U.S. Food and Drug Administration (US FDA) as~     Sylvant for human immunodeficiency virus (HIV)-negative and human herpesvirus-8~     (HHV-8)-negative multicentric Castleman's disease.~   "
58846|NCT02796625|"~     The investigators will use non-invasive recordings of brain activity to measure pain as a~     proxy to self-report. Participants will undergo testing for about 3 hours on two separate~     days. The testing will involve experiencing painful heat.~   "
58829|NCT02796846|"~     The purpose of this study is to evaluate the pre and postoperative CPAP compliance rate in~     OSA surgical patients with or without a CPAP prescription. In this study, all diagnosed OSA~     patients with or without a CPAP prescription will be approached for informed consent to~     enroll in the study. Documented OSA is defined as an OSA diagnosis based on a previous~     laboratory or portable PSG, or on the prescription of CPAP for OSA. The patients with a CPAP~     prescription will be followed up to determine their compliance with CPAP and data will be~     collected to determine the O2 saturation. Those patients with diagnosed obstructive sleep~     apnea without a CPAP prescription will also be followed to objectively determine the severity~     of OSA which would indicate whether they do not require CPAP owing to their mild OSA or they~     in fact may require CPAP due to change in weight etc. Preoperative overnight oximetry will be~     performed on all the OSA patients at home before surgery. In the postoperative period, all~     patients will be followed up with a nocturnal oximetry in the first two post-operative nights~     of hospital stay. Postoperative compliance to CPAP will be evaluated and recorded in all the~     patients. The patients' charts will be reviewed for any postoperative complications. The~     clinical management of patient will be left to the discretion of the perioperative care team.~   "
58830|NCT02796833|"~     Total Parenteral Nutrition (TPN) is a way of feeding a person intravenously, and is required~     when the gastrointestinal tract is not able to function properly. TPN contains carbohydrates,~     protein, and fat and lipids. It also contains minerals and vitamins. The lipid that is~     currently used at the University Health Network home TPN program is Intralipid20%, which is~     based on Soybean oil, contains polyunsaturated fats and is a good source of energy and~     essential fatty acids, including omega 3 and 6 fatty acids, which needed by the body.~     However, long term use on Intralipid20% has been shown to have negative effects on~     antioxidant status, inflammation, liver, and the immune system.~      SMOFlipid20% is a lipid emulsion that has been designed to maximize the ratio of omega 3 to~     omega 6 fatty acids, in an effort to avoid potentially harmful effects associated with~     Intralipid20%. In previous studies, it has been shown that SMOFlipid20% is safe and has~     positive benefits on the liver enzymes. There are no studies so far which follow patient who~     is on SMOFlipid20% long term. The investigators hope to show that with long term use of~     SMOFlipid20% is better for liver function compared to Intralipid20%.~   "
58831|NCT02796820|"~     A randomized, paralleled control clinical study investigating Huaier Granule for prevention~     of recurrence and metastasis of colorectal cancer after radical surgery, to evaluate the~     efficacy and safety.~   "
58832|NCT02796807|"~     Prostate cancer is the second leading cause of cancer death in North American men older than~     50 years. Prostate specific membrane antigen (PSMA) is a unique membrane bound glycoprotein,~     which is overexpressed manifold on prostate cancer cells and is well-characterized as an~     imaging biomarker of prostate cancer. Positron emission tomography / computer tomography~     (PET/CT) is a nuclear medicine procedure based on the measurement of positron emission from~     radiolabeled tracer molecules. 68Ga-HBED-CC-PSMA (DKFZ-11) (abbreviated 68Ga-PSMA) is a~     tracer for prostate cancer PET imaging. The strength of functional imaging methods is in~     distinguishing tissues according to metabolism rather than structure. Studies have shown that~     PET/CT imaging with 68Ga-PSMA can detect prostate cancer lesions with excellent contrast and~     a high detection rate even when the level of prostate specific antigen is low.~      Study Objectives:~      The objective of this study is to evaluate if the patient-wide SUVmax on 68Ga-PSMA PET/CT in~     locoregional and metastatic prostate cancer correlates with histopathologic Gleason score at~     initial biopsy. It is hypothesized that SUVmax will correlate positively with Gleason score.~     This is of interest because non-invasive risk stratification may be possible in the future.~      This will be a single-site JGH-only open label study in which one (1) 68Ga-PSMA PET/CT will~     be performed on study participants. A PET/CT scan takes 2-3 hours.~   "
58833|NCT02796794|"~     To evaluate effects of genistein supplementation to enteral nutrition on inflammatory~     cytokines and morbidity in patients with sepsis~   "
58834|NCT02796781|"~     Interstitial lung diseases (ILD) are a group of diseases affecting the lung interstitium. The~     lung scarring that occurs in ILD is often irreversible with only mitigating therapy available~     so far. This study intends to carry out an open, single-armed, phase I/II clinical trial to~     investigate whether lung stem cells can regenerate damaged lung tissue. During the treatment,~     lung stem cells will be isolated from patients' own bronchi and expanded in vitro. After~     careful characterization, cultured cells will be injected directly into the lesion by~     fiberoptic bronchoscopy. The safety and efficacy of the treatment will be monitored by~     measuring the key clinical indicators.~   "
58835|NCT02796768|"~     Ultrasound imaging (US), a radiation-free imaging modality, is currently used in diagnosis of~     developmental dysplasia of the hip (DDH) in infants. The current protocol involves manually~     identifying specific measures that are prone to error, and may give rise to false positives.~     We aim to use 2-dimensional (2D) and 3-dimensional (3D) ultrasound imaging to create an~     automatic measurement procedure that we hope will reduce the errors in measurement and~     increase reliability.~   "
58836|NCT02796755|"~     The goal of the proposed research is to determine whether riluzole, a drug that increases~     glutamate reuptake, will decrease CNS glutamate in breast cancer survivors with increased~     inflammation and fatigue. We will also determine whether decreasing glutamate with riluzole~     will reverse inflammation-related fatigue and other symptoms including cognitive dysfunction~     and decreased motivation. To accomplish these goals, we plan to conduct an 8 week,~     double-blind, randomized control trial of riluzole (100 mg/d) versus placebo in 40 breast~     cancer survivors (n=20 per group). All breast cancer survivors will have completed treatment~     within 1-3 years and have a fatigue level of ≥4 (on a 10 point scale) and a plasma c-reactive~     protein (CRP) concentration >3mg/L (indicative of high inflammation). Patients will undergo~     magnetic resonance spectroscopy (MRS) to measure CNS glutamate before and after 2 and 8 weeks~     of riluzole or placebo treatment. Fatigue and other behavioral assessments including measures~     of cognitive function and motivation will be conducted before and after treatment and~     correlated with the change in CNS glutamate.~   "
58847|NCT02796612|"~     The project investigates prospectively whether anxiety in the context of breast biopsy can be~     reduced by the planed intervention (take-home brochure and structured and standardized~     information given by a psychologically trained physician who performs the biopsy).~   "
58837|NCT02796742|"~     Methicillin-resistant Staphylococcus aureus (MRSA) is reported as one of the main causative~     pathogen of community acquired SSTIs. In the USA, high prevalence of MRSA among Skin and soft~     tissue infections (SSTIs) is known to be due to the spread of the USA300 clone [Moran et al.~     2006]. Among S. aureus SSTIs infections in Europe, data regarding the prevalence of MRSA in~     SSTIs and the causative genotypes remain scarce. The paucity of literature on the prevalence~     of MSSA, MRSA and PVL-producing S. aureus strains in SSTI in Europe is probably due to the~     fact that culture and antimicrobial susceptibility testing is not a routine component of SSTI~     management.~      Setting-up a prospective multi-centre study involving patients presenting to emergency~     departments with SSTIs in several European countries would allow drawing a picture on the~     role and the respective contribution of MSSA, MRSA and PVL-producing S. aureus strains as a~     cause of SSTIs. However, the roles of emergency rooms and local policies with regard to~     performing microbiological analysis after surgical drainage of SSTIs vary between countries.~      In order to evaluate the feasibility of such multicenter European study, we aim at performing~     a pilot study based on few European clinical laboratories (five to seven) which will: i)~     evaluate the prevalence of MSSA, MRSA and S. aureus PVL-positive strains in~     community-acquired SSTIs; and ii) determine molecular characteristics of the isolated~     strains. The main objectives of this pilot study are to collect some preliminary information~     on the role of S. aureus in SSTIs and to determine factors that need to be harmonized or~     taken into consideration for the set-up a larger prospective cross-sectional study involving~     more European countries with several centers per country to cover different geographical~     areas per country.~   "
58838|NCT02796729|"~     This project will compare two MRI contrast agents in metastatic brain tumours in humans. More~     specifically, the investigators will compare the tumour contrast obtained using glucose~     versus the current standard gadolinium-based contrast agent (GBCA, gadobutrol, trade name~     Gadovist, will be used).~      First, participants will receive a glucose bolus injection followed by glucose enhanced MRI.~     Second, participants will receive a Gd-DTPA bolus injection followed by Gd-DTPA enhanced MRI.~     Both contrast studies will be performed during the same MRI study, which will be under one~     hour long.~   "
58839|NCT02796716|"~     This research will test a new ultra-rapid technology (called ID/AST Accelerate system) that~     uses a digital microscope to identify bacteria based on their growth patterns. This method~     does not have to wait for bacteria to grow in a lab. The new method can identify the type of~     bacteria within 2 hours of receiving a specimen. The new method also shows the effect of~     selected antibiotics on the bacteria including multidrug resistant bacteria so that doctors~     know within 6 hours from specimen collection which antibiotic kills the bacteria.~      To check the accuracy, speed and impact of the new method on antibiotic prescribing,~     investigators are proposing a study with two parts; The first part will test the accuracy and~     speed of the results obtained by the new method. The second part will test if having the~     results from the new method early would change the antibiotics prescribed to a patient in a~     simulation experiment. An independent infectious disease physician will be shown the results~     from the new method and asked if the results were accurate, would it change the antibiotic~     treatment for the patient.~   "
58840|NCT02796703|"~     Prophylactic probiotics have been shown to decrease the incidence of Necrotizing~     Enterocolitis (NEC) in premature neonates. However, there is some resistance to giving live~     bacteria to small babies. Based on animal data, the investigators hypothesized that heat~     inactivated probiotics would also reduce NEC.~   "
58841|NCT02796690|"~     The repeated exposition to S. aureus is considered as a determining factor of acquisition of~     the nasal colonization. The healthcare professionals are regularly in touch with this~     pathogenic bacterium. Prevalence of the nasal carriage of S. aureus in this population was~     the object of several studies but little took into account the respect for the rules of good~     hygienic practice. The results of our previous study carried out during the international~     congress of staphylococci (ISSSI, Lyon in August 26-30th, 2012) showed an association between~     the work in a hospital environment and the increase of the risk of nasal carriage. On the~     contrary, the use of the hydro-alcoholic solutions had a protective effect against this~     carriage. However, sized of the health care population of our study was limited.~      The goal of this study is to confirm our previous results on a larger cohort of healthcare~     professionals. The main objective is to estimate the prevalence of nasal carriage according~     to the professional category and by taking into account the degree of conformity with good~     hygiene practices including the use of hydro-alcoholic solutions.~   "
58842|NCT02796677|"~     This is a multiple dose, randomized, parallel, double-blind, double-dummy, multicenter and~     multinational Phase III study to determine the efficacy and safety of Aclidinium bromide~     400μg/Formoterol Fumarate (AB/FF) 12 μg compared to individual components and TIO~     (Tiotropium) 18 μg when administered to patients with stable chronic obstructive pulmonary~     disease (COPD).~   "
58843|NCT02796664|"~     The purpose of this study is to determine whether Ginseng is effective in the prevention of~     atherosclerosis and subsequent ischemic stroke.~   "
58844|NCT02796651|"~     To assess the bronchodilation of three doses of formoterol fumarate (6 μg, 12 μg and 24 μg)~     twice daily (BID) administered via Pressair® compared to placebo and to open-label nebulized~     formoterol fumarate (20 μg and 40 μg).~   "
58845|NCT02796638|"~     The primary hypothesis of this study is: the use of minute ventilation-adaptive~     servo-ventilation (MV-ASV) during hospitalization will mitigate deterioration in renal~     function and prevent kidney injury in patients admitted with acute heart failure (AHF)~     compared to those receiving usual care. We will validate and extend our pilot study by taking~     a deeper dive into the effects of ASV on diuretic dose, urine output and new and exciting~     biomarkers of renal function and kidney injury. If our hypothesis proves correct, it strongly~     suggests that ASV lessens injury to the kidney and could lead to a new paradigm for the~     treatment of AHF. When use of high dose of diuretics are anticipated or in whom chronic~     kidney disease (CKD) or acute kidney injury (AKI) is present on arrival to the Emergency~     Department, use of MV-ASV might decrease the amount of diuretics needed, allow for continued~     use of ACE inhibitors, and ultimately mitigate rises in creatinine and decreases in effective~     glomerular filtration. Since kidney injury is a major factor in those patients with early~     30-day readmission following discharge, this therapy could become quite popular.~   "
70964|NCT02638103|"~     A study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous~     administration of TEV-48125 in adult patients with chronic migraine or episodic migraine~   "
58850|NCT02796573|"~     Depression is a prevalent and disabling disorder with great cost to the individual and the~     society. Lately, the use of internet interventions as guided self-help has demonstrated~     remarkable results. However, certain shortcomings such as lack of personal adaptation has~     been identified.~      The presents study aims to investigate the potential of blending Internet based interventions~     with face-to-face consultations using cognitive behavioural therapy (B-CBT). The main~     hypotheses are, that that B-CBT will be as clinically effective as TAU, and that it will be~     acceptable to patients and clinicians.~      The study is designed as a two arm randomised non-inferiority trial comparing internet based~     B-CBT for depression to treatment as usual (TAU) defined as 12 sessions of face-to-face CBT.~   "
58851|NCT02796560|"~     The purpose of this study is to compare the efficacy and tolerance of generic travoprost with~     its brand name formulation. In this open label, randomized, crossover study, the primary~     outcome will be intraocular pressure and the secondary outcome will be tolerance to the~     drops, as measured by a subjective questionnaire. Patients will be randomized to receive~     either brand name or generic travoprost during the first visit. At the second visit 3 weeks~     later, their intraocular pressure will be measured and a questionnaire will be completed on~     the tolerance of the medication. Patients will then receive the other formulation of~     travoprost. At the third and final visit, another 3 weeks later, their intraocular pressure~     will be measured and a questionnaire will be completed on the tolerance of the second~     medication.~   "
58852|NCT02796547|"~     An episiotomy is an incision of the perineum to facilitate childbirth by natural means.~     Perineal pain are more frequent and intense if the incision of the perineum is important. In~     particular, simple vaginal or perineal tears are less painful than episiotomies in the first~     seven days postpartum, whereas at six weeks postpartum, there is no significant difference~     anymore.The patients are the most symptomatic in the immediate postnatal period, but the pain~     may persist up to 2 weeks after delivery in 20 to 25% of cases. These pains are often~     undervalued and may interfere with the mother-child bond in the absence of an effective~     treatment. Perineal pain are usually treated with painkillers, in particular non-steroidal~     anti-inflammatory drugs given orally or rectally and paracetamol.~      The scar infiltration is one of the components of a multimodal postoperative analgesia~     strategy. It consists in the simultaneous use of several drugs or analgesic techniques,~     acting on different pain components in order to improve the overall efficiency.The most used~     local anesthetics at present are bupivacaine, ropivacaine and levobupivacaine.Ropivacaine has~     a lesser vasodilatory effect than bupivacaine, resulting in longer persistence at the~     injection point and a blood resorption that is more spread. The systemic toxicity threshold~     is also higher. Levobupivacaine is the enantiomer of bupivacaine. It has vascular effects,~     and an intermediate systemic toxicity threshold intermediate between bupivacaine and~     ropivacaine. Lidocaine has a limited duration of action. Its use is interesting in complement~     infiltrations when a rapid onset of action is desired.~      So far, there is no data in the literature regarding the effect of levobupivacaine in~     episiotomies associated pain. The objective of this study is to evaluate the effect of local~     injections of levobupivacaine on episiotomies associated pain.~   "
58853|NCT02796534|"~     Patients with type 1 diabetes have poorer glycemic control that could lead to macrovascular~     or neuropathic complications; in addition to an optimal treatment, prevention of diabetes~     complications requires to control associated risk factors, such as hypertension or~     dyslipidemia. Sleep apnea syndrome is a public health problem due to its high prevalence and~     marked morbidity and mortality, one increasingly interesting aspect is its relationship with~     metabolic disorders, specifically diabetes.Obstructive sleep apnea syndrome seems to be~     underestimated in this population. In this context, it appears to be important to estimate~     the prevalence of sleep respiratory diseases in patients with type 1 diabetes.~   "
58854|NCT02796521|"~     At hospital, short term actions are used (adaptation of meals, oral supplementation…) to~     fight malnutrition. Oral supplementation can have a positive impact on weight gain. But~     actions should continue at home, particularly to maintain autonomy for elderly. The~     hypothesis is that practical workshop about enrichment and interest of foods can help~     malnourished patients to change their eating habits. The main goal of this study is to~     evaluate the effects of this workshop on improving nutritional status, measured by Mini~     Nutritional Assessment~   "
58855|NCT02796508|"~     Neuroplasticity-based approaches seem very promising to maintain cognitive health in older~     adults and postpone the onset of cognitive-decline and dementia symptoms. The aims of this~     project are threefold:~        1. the evaluation of the effects of a neuroplasticity-based-cognitive randomized~          computer-based intervention consisting in training with non-action video games on brain~          and cognitive functions that decline with ageing, including attention and spatial~          working memory (WM), in older adults using behavioral measures and electrophysiological~          recordings (event-related potentials -ERPs- and event-related spectral perturbations~          -ERSPs);~        2. the study of the effects of age and 3 months maintenance on the cognitive and neural~          signatures of transfer effects to attentional and spatial WM tasks; and~        3. to investigate the neuroinflammatory mechanisms assessed by non-invasive methods in~          saliva from participants underlying cognitive training-induced effects.~      A better understanding of these mechanisms elucidates pathways that may be targeted in the~     future, either by behavioral or neuropsychological interventions. To achieve these aims, the~     investigators will recruit between 60-80 older adults volunteers to participate in the~     randomized, controlled, single-blind study. After screening, participants will be randomly~     distributed in one of these two groups: experimental and active control. Participants in the~     experimental group will receive 16 1 hour computerized training with non-action video games.~     The active control group will receive 16 1 hour training sessions with a social video game.~     The design is a mixed factorial design with type of intervention (experimental, active~     control) and assessment session (pre, post, maintenance). The results from the proposed~     research project will clarify the existence of transfer-of-benefit and neural mechanisms~     underlying cognitive improvement. The hypothesis is that mental stimulation through~     non-action video games will improve attention and memory, promoting brain and mental health,~     and extending independence among elderly people by avoiding the negative personal and~     economic consequences of long-term care.~   "
58856|NCT02796495|"~     Phantom limb pain (PLP) is a frequent consequence of amputation, and it is notoriously~     difficult to treat. Amputation usually follows traumatic injuries or surgery following~     vascular diseases, diabetes, osteomyelitis or tumours in cases where the loss of the limb is~     required for the survival of the patient. The loss of a limb or other body parts is usually~     followed by the sensation that the lost body part is still present and can be felt. These~     phenomena are called, respectively, phantom awareness and phantom sensation. In 50-80% of~     amputees neuropathic pain develops in the lost limb also referred to as phantom limb pain~     (PLP). PLP can be related to a certain position or movement of the phantom limb, and might be~     elicited or worsened by a range of physical factors (e.g. changes in the weather or pressure~     on the residual limb) and psychological factors (e.g. emotional stress). It is well known~     that most treatments available for PLP today, such as pharmacological, surgical, anaesthetic,~     psychological and other, are ineffective.~      Today it is believed that phantom limb pain may be related to changes in the cortex of the~     brain. There is evidence that these changes may be modulated - or even reversed - by~     providing sensory input to the stump or amputation zone. For example, cortical reorganization~     and alleviation of phantom limb pain has been observed in amputees following intense use of a~     hand prosthesis. However, there is no consistent knowledge on which type of peripheral~     sensory feedback may be effective in affecting the cortical plasticity or on how to best~     apply the sensory feedback.~      The aim of the proposed research is to create natural, meaningful sensations through~     providing invasive sensory feedback (i.e. electrical stimulation through intraneural~     implantation of electrodes) and the effectiveness to alleviate phantom limb pain and restore~     the cortical neuroplastic changes.~   "
58888|NCT02796079|"~     Stem cell therapy has been a new and effective therapy in recent years for diabetic foot.This~     study intends to establish an optimal clinical research program, and attempts to break the~     technical bottleneck in the stem cell therapy for treating diabetes related vascular~     complications.~   "
58889|NCT02796066|"~     The purpose of this study is to determine the safety and effectiveness of TSN 2898 topical~     gel in the treatment of moderate to severe acne.~   "
58857|NCT02796482|"~     This open-label, prospective, controlled intervention study involves evaluating tolerance and~     acceptability of an Oral Nutrition Supplement (ONS; EnergieShake® 1.5 kcal Complete drink) in~     18 adult patients who are already taking an ONS. Following a 2-day baseline data collection~     on their current ONS, patients switch to the test ONS, which is taken for a further 8~     consecutive days. Patients revert to their current ONS at the end of the study. Patients act~     as their own controls and thus all patients are allocated the same intervention.~      Daily records of GI tolerance and compliance with the prescribed amount of ONS will be kept~     for participants throughout the study period. Participants' height and weight will be~     collected at baseline (weight at end will also be collected), all medications will be~     documented, and relevant medical and dietary histories will be recorded. A questionnaire at~     the end of the intervention period will be administered collecting participants' views on the~     acceptability (taste and palatability) of the test ONS. Taste and palatability will be~     assessed via a questionnaire that uses a Hedonic scale to quantify preference.~   "
58858|NCT02796469|"~     In the specific setting of the evaluation of corticosteroids, pentoxifylline of their~     combination in severe alcoholic hepatitis, only meta-analysis combining individual data is~     able to provide detailed information from each individual with severe alcoholic hepatitis~     assessed by a DF ≥ 32. The need for such an approach is confirmed by the fact that in both~     univariate and multivariate analyses, truth survival is lower for conclusions from~     meta-analysis of the literature than for conclusions derived from non-meta-analyses.~      The present study is a meta-analysis of individual data from RCTs restricted to patients with~     a DF ≥ 32. The primary endpoint will be to compare 28-day survival of patients receiving~     either corticosteroids, or pentoxifylline or their combination to those of patients not~     receiving them adjusted on the independent prognostic factors at baseline.~      The secondary endpoints will be: a) assessment of response to the assigned treatment using~     the Lille model; b) analysis of 6-month survival according to allocated therapy.~   "
58859|NCT02796456|"~     Background :~      Apelin and its receptor APJ have been implicated in pathologies including cardiovascular~     disease, diabetes and obesity. Little is known about the function of the apelinergic system~     during gestation.~      Objective :~      The main objective of this study is to compare apelinemia in fasting normal weight and obese~     women at the end of pregnancy, between 35 and 41 weeks of gestation (WG).~      Strategy and method:~      A prospective research evaluating will be conducted to compare apelinemia in fasting normal~     weight and obese women at the end of pregnancy, between 35 and 41 weeks of gestation (WG).~      A third group will be created to check if gestational diabetes is not a confounding factor in~     obesity (group of obese women with gestational diabetes).~      Investigators will try to see if apelinemia is correlated to lipidic and glycemic markers.~      Samples will be collected in the cord blood to compare maternal and neonatal apelinemia and~     to see if neonatal apelinemia is correlated to the child's weight and birth size and to the~     weight of the placenta.~      Placenta samples will be collected and RT-qPCR will be done to analyze RNA in each group.~      Two days after delivery, obese and not obese women will be fasted and plasma and colostrum~     will be collected. Investigators will compare apelin levels in the colostrum between these 2~     groups and then investigators will try to see if apelin level is correlated in the colostrum~     and in maternal plasma.~   "
58860|NCT02796443|"~     Meta-analysis of randomized controlled trials and population based studies in acute~     cholecystitis are in favor for early laparoscopic surgery versus a delayed operation several~     weeks later. The main problems in these studies are the exclusion criteria used, thus not~     reflecting the real world setting of acute cholecystitis. The purpose of this study is to~     demonstrate that a delayed laparoscopic cholecystectomy in a real world scenario has no worse~     outcome in comparison with an early operation (within 72 hours after onset of symptoms).~   "
58861|NCT02796430|"~     This study will evaluate the ease of use of the new calorimeter (Q-NRG (COSMED, Italy)) in~     intensive care unit (ICU) patients compared to currently used calorimeters (i.e. Quark RMR~     1.0(COSMED, Italy) or Deltatrac Metabolic Monitor (Datex, Finland)), as well as the stability~     and the feasibility of the measurements in various clinically relevant situations.~      Time needed to prepare and start indirect calorimetry (IC) measurement will be compared as~     the measure of the ease of use of the calorimeter.~   "
58862|NCT02796417|"~     This study examined the efficacy of an integrative cognitive remediation program (REHACOP) to~     improve cognition, social cognition, clinical symptoms and functional outcome in patients~     with schizophrenia.~   "
58863|NCT02796404|"~     The current state of mobile communication and technology is a tool to support home programs~     for chronic disease management, useful to facilitate access to these types of programs,~     because the investigators could obtain telematics information about the parameters, reducing~     cardiovascular risk factors and cardiovascular morbidity and mortality.~   "
58864|NCT02796391|"~     STUDY 1: INTERVENTION DEVELOPMENT The purpose of this study is to determine the best way to~     help people stop smoking by using very low nicotine content (VLNC) cigarettes. This~     developmental pilot study (n=20) will determine the feasibility of the treatment approach and~     methodology using a targeted intervention, and lead to refinements for a subsequent~     randomized controlled trial (RCT).~      STUDY 2: RANDOMIZED CONTROLLED TRIAL The purpose of this study is to see if a targeted~     intervention will help people to stop or reduce smoking better than a standard intervention~     using very low nicotine content (VLNC) cigarettes, and to determine the optimal nicotine~     tapering schedule (gradual vs. immediate) during a 5-week pre-quit period. About 208~     participants will take part in this phase of the study at Moffitt Cancer Center.~   "
58890|NCT02796053|"~     Study to assess Pharmacodynamics, Safety, Pharmacokinetics and clinical effects of TAB08~     during 12 weeks of treatment in patients with Psoriasis Vulgaris, not adequately controlled~     with current therapy.~   "
58902|NCT02795884|"~     This study will be performed as a local multicenter, randomized, phase III clinical study. It~     will compare the adjuvant chemotherapy in Stage IB-IIIA NSCLC with common EGFR mutation (Exon~     19 deletion or L858R) who underwent total resection and the Erlotinib-Intercalation adjuvant~     chemotherapy with the chemotherapy alone. The patients will be randomly assigned to the~     Intercalation combination chemotherapy regimen and the chemotherapy alone regimen at the~     ratio of 1:1. The treatment regimen of each arm is as follows.~   "
70499|NCT02644174|"~     In this prospective study we will evaluate the changes in respiratory physiology occurring in~     morbidly obese adolescents following bariatric surgery at Schneider Children's Medical Center~     of Israel (SCMCI).~   "
58865|NCT02796378|"~     Background. Statins are cholesterol lowering drugs that are prescribed to lower the risk of~     cardio-vascular diseases. The use of statins has increased markedly and it is now one of the~     most prescribed drugs in the world. More than 600,000 people in Denmark are taking statins on~     a daily basis, approximately 40 % of these are taking the medication without having any other~     risk factors for cardio-vascular diseases than elevated blood-cholesterol i.e. they are in~     primary prevention.~      Statins are not without side effects and studies have shown that there is an elevated risk of~     developing diabetes when taking statins. This has led to an increased debate about the use of~     statins in primary prevention. Furthermore a large meta-analysis has shown that to prevent~     one event of cardio-vascular disease, it is necessary to treat 200 people for 3-5 years.~     These data suggest that more conservative use of statins to prevent CVD in otherwise healthy~     individuals at low risk for future CVD may be warranted.~      Other side effects of statins are muscle myalgia, muscle cramps and fatigue which potentially~     can prevent a physically active lifestyle. The biomedical background of these side effects is~     not fully elucidated but it has been shown that there is a link to decreasing levels of an~     important enzyme, Q10, which plays a role in muscle energy metabolism.~      Hypothesis~      The overarching research question is: why does statin treatment cause muscle pain? Does~     statin treatment impair (or even prohibit) physical exercise training? Furthermore the~     following questions will be investigated:~      A. Does statin treatment cause:~        1. Decreased muscle strength?~        2. Skeletal muscle inflammation?~        3. Decreased mitochondrial respiratory function? B. Abnormal glucose homeostasis?~      Re question A & B: If so, can physical training counteract this effect of statin treatment?~   "
58866|NCT02796365|"~     The purpose of this study is to identify patients at risk for future heart failure using~     novel markers of early cardiac damage and determine if exercise training can improve these~     emerging markers as well as overall fitness and quality of life.~   "
58867|NCT02796352|"~     This study is for patients with advanced stage III or stage IV melanoma not adequately~     treated by surgery who have progressed after treatment with nivolumab or pembrolizumab. The~     purpose of this study is to see if giving high dose interleukin-2 (IL-2) after progression on~     nivolumab or pembrolizumab is effective in treating metastatic melanoma. This study is also~     being done to look at the severity of side effects of IL-2 in patients.~      IL-2 is approved by the U.S. Food and Drug Administration (FDA) for the treatment of advanced~     melanoma.~   "
58868|NCT02796339|"~     The purpose of this study is to assess the effectiveness of a supplement with natural Mastiha~     on Inflammatory Bowel Diseases (IBD). U.S. Food and Drug Administration has classified~     Mastiha as GRAS. Previous research demonstrates Mastiha's safety, as well as~     anti-inflammatory, antimicrobial and antioxidant properties. In addition, the European~     Medicine Agency has recently recognized Mastiha as a natural medicine and classified it to~     the category of traditional herbal medicines in diarrhea problems, mild dyspeptic disorders,~     skin inflammation and healing (EMA/HMPC/46758/2015). Since IBD is a chronic disease~     characterized by inflammation and oxidative stress and based on previous small-scale studies,~     the present study aims at demonstrating the effectiveness of this supplement adjunct to the~     conservative treatment of IBD.~      To this end, confirmed IBD patients, with distinguished Ulcerative Colitis (UC) and Crohn's~     Disease (CD) will be enrolled based on certain inclusion and exclusion criteria. The staff of~     the study will provide detailed information regarding the aims, the methods, anticipated~     benefits and potential hazards of the study and all patients will receive the Patient~     Information Leaflet (PIL). Ample time (48 hours) will be provided in order to decide whether~     they want to participate in the protocol. Each patient agreeing to participate will sign an~     Informed Consent document and the staff will explain to patients that they are under no~     obligation to enter the trial and that they can withdraw at any time during the trial,~     without having to give a reason. A copy of the signed Informed Consent will be given to the~     participant.~      100 IBD patients will be allocated to either Mastiha or placebo group. The Mastiha group will~     receive natural Mastiha supplement at a dose of 2.8 g daily while placebo group will receive~     respectively placebo. The intervention will last 3 months for patients in relapse and 6~     months for patients in remission. They will receive all the supplements they will consume~     during the intervention at the start of the trial. Both groups will continue their medical~     treatment, which must be unaltered throughout the trial. Additionally, all patients will~     receive standard nutritional advice by dieticians and will be encouraged to report any~     adverse effects they may experience during the intervention. The trial will be blinded in all~     implicated persons; neither the staff of the trial nor the patients will be aware of which~     kind intervention they receive.~      Patients are assessed after randomisation according to the following tools:~        -  Medical history~        -  Dietary history~        -  Harvey & Bradshaw Activity Index Assessment~        -  Mayo Activity Index assessment~        -  Anthropometric data measurement: body weight (kg), height (cm), Body Mass Index (kg/m2)~        -  Inflammatory Bowel Disease Questionnaire~        -  DNA isolation from whole blood.~        -  Biochemical measurements: Complete blood count, albumin, lipid profile, glucose,~          electrolytes, liver enzymes, amylase, fibrinogen.~        -  Evaluation of inflammation in serum samples. Circulating serum levels of IL-6, IL-8,~          IL-17A, IL-17F, IL-18, IL-21, IL-22, TL1A, TGF-β, ICAM-1, MADCAM-1 and E-selectin are~          measured), in all active CD and UC patients. Inflammatory markers are also estimated in~          stool samples: calprotectin, lactoferrin and lysozyme,~        -  Oxidative stress assessment in serum/plasma samples. Oxidised LDL, serum oxidisability~          and F2-isoprostanes are quantified.~        -  Detection of metabolites and complete metabolomic profile in plasma samples.~        -  Stool samples collection for the assessment of gut microbiota in active patients.~        -  Genetic and epigenetic profile~      Subsequent assessments: There is a biweekly telephone contact with the patients to monitor~     compliance and side effects. At the end of the intervention each subject undergoes the~     baseline assessment.~   "
58869|NCT02796326|"~     The purpose of the study is to prospectively assess the use of a modified tracheal balloon~     dilator that allows gas flow (oxygenation and ventilation) through the device while inflated~     during dilatation.~   "
58870|NCT02796313|"~     We will conduct a randomized trial to test our DASH (Dietary Approaches to Stop Hypertension)~     based intervention in 400 adult American Indians with inadequately controlled systolic blood~     pressure (≥140 mmHg). Over the 5 years of the project, we will recruit and randomize 200~     participants from each of 2 urban sites in Washington and Oklahoma.~      In addition, we will conduct a pilot study after the 8 week intervention concludes to test~     whether providing 6 additional week of dietitian support (without the grocery supplement) can~     help improve blood pressure over the long term.~   "
58871|NCT02796300|"~     Numerous catheter designs have been studied to increase efficacy and minimize complications~     of catheter hemodialysis. Major complications of catheters include thrombosis, central venous~     stenosis, infection, and dialysis inadequacy. Thrombosis must be avoided if possible because~     using too many catheters may exhaust all of the catheter insertion sites on the body, as well~     as increase the risk of infection. This prospective study compares the complications and~     general outcomes of patients who receive hemodialysis using the mainstream Palindrome~     catheter versus the newer BioFlo DuraMax catheter.~      This study will examine outcomes of patients who receive hemodialysis using either the~     Palindrome catheter or the BioFlo catheter. Patients will be observed and outcomes will be~     recorded for three to six months. Outcomes will be analyzed and compared to draw conclusions~     on which catheter produces less catheter thrombosis.~   "
58872|NCT02796287|"~     The transient global amnesia (IA) is defined clinically as a temporary suspension and~     isolated from the ante and retrograde memory, totally regressing within 24 hours. The causes~     of AI remain unknown. The diagnosis of IA is based on consensus clinical criteria including~     the absence of associated location marks. In clinical practice, the MRI is often performed in~     conjunction with clinical examination because it ensures the absence of differential~     diagnoses, including stroke.~      The visualization of MRI signal abnormalities related to AI directly dependent on the~     completion time of the review in relation to the onset of symptoms. Typically, no signal~     abnormality is visible in the hyperacute phase (ie D0-D1) while punctate appear hyperintense~     on diffusion sequences in hippocampal structures from J2 to J7 to disappear completely. It~     has been previously demonstrated that the use of higher values of b and / or a better spatial~     resolution significantly increases the sensitivity of the broadcasting sequence for the~     detection of these abnormalities hippocampal signal. At St. Joseph Hospital, Investigators~     explore the AI suspected patients with diffusion tensor sequence (DTI) on our high resolution~     3T MRI.~      Compared to the classical diffusion sequence, DTI is characterized by the use of a greater~     number of directions in which the diffusion gradients are applied. One advantage of this~     technique is to be able to perform tractography of white matter fibers. Thus the connectome~     is a new technique for post-processing of DTI images based tractography and to assess all the~     networks of nerve fibers in the brain. By this technique, the values of average diffusivity~     (MD) and fractional anisotropy (FA) can be measured along each of the studied nerve fibers.~     Group studies thus become feasible to compare quantitatively healthy subjects and patients~     groups in terms of structural differences within the connectome. The contribution of this~     technique was recently highlighted in patients with temporal lobe epilepsy.~   "
58873|NCT02796274|"~     The purpose of this survey is to collect visual acuity data from patients with LHON in order~     to establish the clinical course (natural history) and visual acuity outcomes in patients~     with a genetically confirmed diagnosis of LHON. In addition, this survey will generate data~     that will serve as comparator for the open-label study SNT-IV-006.~   "
58874|NCT02796261|"~     The purpose of this study is to compare the efficacy and safety of eflornithine in~     combination with lomustine, compared to lomustine taken alone, in treating patients whose~     anaplastic astrocytoma has recurred/progressed after radiation and temozolomide chemotherapy.~   "
58891|NCT02796040|"~     Impulse control disorders (ICD) are frequent in Parkinson's Disease. Neurobiological~     substrates of these symptoms are largely unknown.~      The investigators aim to explore mesocorticolimbic pathway in Parkinson's disease patients~     with impulse control disorders (ICD) using an MRI technique called tensor diffusion imaging~     (DTI).~      More precisely, the main purpose is to demonstrate that fractional anisotropy (FA) (data~     obtained with DTI) in the ventral tegmental area (VTA) is different between patients with ICD~     and patients without ICD. Secondary objectives are to demonstrate a difference in volume of~     VTA, in FA in others structures included in reward system (prefrontal cortex, nucleus~     accumbens, amygdala), and in number of fibers between VTA and the other structures of reward~     system between this two groups. Other objective is to measure and compare these same~     variables between Parkinson's patients and healthy controls.~      We hypothesized that a denervation of mesocorticolimbic pathway predisposes Parkinson's~     patients to ICD.~   "
70886|NCT02639130|"~     To determine the extent to which the effects of treatment with LAF237 100 mg QD on glucagon~     secretion are mediated by Glucagon-like-peptide 1 (GLP-1) in type 2 diabetic patients and~     healthy subjects.~   "
58875|NCT02796248|"~     Stigma related to chronic disease is rejection or judgement or exclusion by others that is~     related to the chronic disease itself and is unwarranted. We are trying to figure out what~     proportion of young people with type 1 diabetes experience stigma in Canada. By young people,~     we mean teenagers and young adults; specifically, people who are between 14 and 25 years of~     age. This is a challenging period in life when identities are developed and peer opinions are~     felt to be particularly important. Experiencing stigma in this life period may be especially~     hurtful and may have bad effects on taking care of type 1 diabetes. This may lead to~     important medical problems like dangerously low or high blood sugar values. By understanding~     how common stigma is, we can figure out the need for programs and strategies to deal with it.~      We will ask young people with type 1 diabetes to help us study this problem by completing an~     online survey. We will 'advertise' our study through type 1 diabetes clinics, websites, and~     social media. People who are eligible and interested will click on an internet link and be~     directed to the survey. Staff at clinics in Montreal, Calgary, and Vancouver will also draw~     their attention to the posters and/or provide small flyers with the internet link for the~     study.~      Participants will be asked about their general sense of well-being, their habits and~     behaviours, and their blood sugar control, including frequency of both lows and highs. They~     will also be asked if they are willing to mail in a small blood sample. If yes, they will~     receive a kit with a small lancing device and instructions on how to clean their finger tip,~     prick it, and express a few drops of blood into a small container. They will then mail this~     back to us in a postage-paid envelope. We will use this to measure their hemoglobin A1c, an~     overall measure of blood sugar control.~      We will use this information to (1) calculate the proportion of young people with type 1~     diabetes who experience stigma; (2) figure out what factors and behaviours might predict or~     signal the experience of stigma; (3) see if there is a link between stigma and A1c control~     and/or frequent lows by report; (4) explore challenges and solutions voiced through the~     open-ended questions.~   "
58876|NCT02796235|"~     Venous Thromboembolic Disease (VTE) in SCI patients is very common, its prevalence is 60 to~     80% against 10-20% in the general population.~      The risk of VTE is very important in the first weeks after spinal cord injury, and then~     declines with a prevalence of VTE slightly higher than the general population after 12 weeks.~     However there is no prospective study of incidence of VTE in SCI patients after 3 months. The~     investigators wish to conduct such a study during the year following spinal cord injury with~     performing venous Doppler ultrasound of the lower limbs 6, 9 and 12 months of the initial~     injuryassociated with a standardized clinical assessment, to know the incidence of VTE and~     determine prognostic factors for VTE.~   "
58877|NCT02796222|"~     Recombinant factor VIII Fc (rFVIIIFc) and recombinant factor IX Fc (rFIXFc) are extended~     half-life coagulation factors approved by Health Canada in 2014 for the treatment of severe~     hemophilia A and B, respectively. The objectives of this observational study is to describe~     the change in annual factor consumption, clinical and patient-reported outcomes for patients~     who switch from recombinant factor VIII (rFVIII) and recombinant factor IX (rFIX) to~     rFVIIIFc/ rFIXFc in Canada, and to explore clinicians' and patients' reasons for switching or~     not switching.~   "
58878|NCT02796209|"~     Atomoxetine, a selective norepinephrine transporter (NET) blocker, increases standing blood~     pressure and improves neurogenic orthostatic hypotension (NOH)-related symptoms to a greater~     extent than midodrine, the current standard of care. Atomoxetine could be a new therapeutic~     alternative for the treatment of NOH in patients with autonomic failure, particularly those~     with multiple system atrophy (MSA).~      The proposed study consists of an open-label, dose-optimization phase followed by a~     randomized, double-blind, placebo-controlled, 2x2 crossover phase.~   "
58879|NCT02796196|"~     This research trial studies prescribed physical activity in improving sleep and physical~     performance in patients undergoing stem cell transplant. A wearable physical activity monitor~     can be used to record minutes of activity and sleep. Gathering data over time using a~     physical activity monitor may help doctors learn if prescribed physical activity helps~     improve sleep and physical performance in patients undergoing stem cell transplant.~   "
58880|NCT02796183|"~     This study evaluates the effects of subconjunctivally injected bevacizumab in patients with~     diffuse diabetic macular edema.~   "
58881|NCT02796170|"~     To assess the effect of SGLT-2 inhibitors on blood pressure and urinary angiotensinogen. This~     is a cross over study design, where 40 subjects will receive Dapagliflozin for 6 weeks~     followed by placebo for 6 weeks, or placebo for 6 weeks followed by Dapagliflozin for 6~     weeks. In addition there will be an arm of 10 subjects who will receive sulfonylurea in an~     open label as a comparative to the cross over subjects to assess if the effect of~     Dapagliflozin may also be in part due to improved glycemic control.~   "
58882|NCT02796157|"~     PCI of diffuse long coronary lesions still remains challenging because of relatively high~     risk of in-stent restenosis and stent thrombosis compared to short coronary lesions. The~     purpose of the study is to compare an incidence of composite of major adverse cardiovascular~     events (MACEs) at 1 year between Absorb everolimus-eluting BVS and Xience EES after coronary~     intervention in long lesions.~   "
58883|NCT02796144|"~     Purpose: The purpose of this study is to test new pharmacologic strategies for weight loss in~     patients with schizophrenia, a population for which no current weight-loss treatments have~     gained widespread use. The goal is to recruit overweight people with schizophrenia to~     participate in a 52-week double-blind, randomized study to assess the efficacy and safety of~     lorcaserin/metformin combination treatment, lorcaserin monotherapy, and placebo on weight,~     body composition, and measures of glucose and lipid metabolism.~      Participants: Approximately 110 subjects will be enrolled at two clinical sites (UNC Chapel~     Hill and Columbia University)~      Procedures (methods): Behavioral: All participants will be offered a behavioral intervention~     of weekly diet and exercise counseling aimed at modifying cardiovascular risk factors. This~     intervention will be provided at all in-person study visits after the Baseline Visit and~     supplemented with weekly interim phone calls to reinforce lessons between visits.~     Pharmacological Intervention: All participants who meet entry criteria will be randomized to~     one of the three treatment groups (lorcaserin/metformin, lorcaserin, and placebo).~   "
58884|NCT02796131|"~     A Phase 1, single-center, randomized, double-blind, placebo-controlled study to evaluate the~     safety, tolerabiltiy, and pharmacodynamics of different multiple dose regimens of RDX5791 in~     healthy volunteers.~   "
58885|NCT02796118|"~     The objective of this study is to evaluate the safety and the pharmacokinetics of ASP2151~     after multiple oral dosing of ASP2151 in healthy non-elderly male and elderly male Japanese~     subjects, and to compare the pharmacokinetics of ASP2151 in healthy non-elderly male and~     elderly male Japanese subjects.~   "
58886|NCT02796105|"~     Evaluation of efficacy and safety of medroxiprogesterone acetate (Progevera 10 mg®) versus~     GnRh antagonist (Orgalutran®) in ovarian stimulation cycles of oocyte donors~   "
58887|NCT02796092|"~     This prospective randomized study compares the safety and efficacy of two different~     embolizing agents for the treatment of pelvic congestion syndrome: fibered platinum coils and~     vascular plugs.~   "
58892|NCT02796027|"~     Scaling up integrated, cost-efficient HIV services for people who inject drugs (PWID) in~     Needle Syringe Programs (NSPs) is urgently needed in Kazakhstan, where only one-third of the~     estimated 19,000 HIV-positive PWID are ever linked to HIV care and only 10% initiate ART with~     4% achieving viral suppression. The study's aim is to evaluate the implementation,~     effectiveness, and sustainability of an integrated HIV service model in 24 NSPs located in 4~     Kazakhstani cities. This model will employ highly effective strategies that will include~     peer-driven recruitment of PWID in NSPs using social network strategies (SNS), integrating~     rapid HIV testing in NSPs with HIV Care Clinic nurses, and linking HIV positive PWID in NSPs~     to HIV care using the ARTAS (Anti-Retroviral Treatment and Access to Services) case~     management model. Findings will have important public health implications for improving HIV~     service delivery for PWID in the Central Asian region and other countries with injection~     driven epidemics.~   "
58893|NCT02796014|"~     The Dermatological Diseases Family Impact Scale (DeFIS) was developed to assess different~     aspects of health-related quality of life in the relatives of the patients with various skin~     diseases. The preliminary validation of this instrument was performed for the Turkish~     population. In the pilot study, this 15-item-questionnaire was shown to be easy to complete~     and score, and reliably help to evaluate the family members' quality of life.~      Psoriasis is a chronic disease which can be expected to have a significant impact on the~     quality of life of the patients and parents/family members alike. In line with this~     assumption, previous studies demonstrated that psoriasis psychosocially affects not only the~     patients, but also their close relatives. The psoriasis family index has been developed in an~     effort to objectively measure the health-related quality of life of the family members of~     patients with psoriasis. Nevertheless, data regarding the health-related quality of life of~     the parents of pediatric patients with psoriasis in the Turkish population are relatively~     scarce.~      In study, the investigators primarily aim to utilize DeFIS to assess the impact of childhood~     psoriasis on the quality of life of the patients' parents. Further, the investigators attempt~     to investigate the relation between the quality of life of the patients and their parents,~     and reveal disease characteristics which might influence the quality of life.~   "
58894|NCT02796001|"~     The primary objective of this study is to assess the relationship between rhinovirus specific~     T-cell immunity and the human host response to primary rhinovirus challenge and subsequent~     secondary challenge with either homologous or heterologous rhinovirus serotypes.~   "
58895|NCT02795988|"~     The Phase 1b study is an open-label, multicenter dose escalation study designed to assess the~     safety, tolerability, immunogenicity and recommended phase 2 dose (RP2D) of IMU-131. The RP2D~     will be evaluated in the dose expansion Phase 2 study.~   "
58896|NCT02795975|"~     The objective of this study is to evaluate the performance characteristics of the AC2 assay~     on the Panther system using female urine specimens.~   "
58897|NCT02795962|"~     To evaluate the hypothesis that direct transfer to an Endovascular Stroke Center, compared to~     transfer to the closest Local Stroke Center, offers a better outcome in the distribution of~     the modified Rankin Scale scores at 90 days in acute ischemic stroke patients with clinically~     suspected Large Vessel Occlusion identified by Emergency Medical Services (EMS).~   "
58898|NCT02795949|"~     The continuous increase in the bacterial resistance rate and the slow arrival of new~     therapeutic options have turned into an antibiotic crisis. One of the strategies proposed by~     stewardship programs to try to change this situation described worldwide is the use of~     antibiotics with the lowest possible antimicrobial spectrum.~      Enterobacteriaceae bacteremia is a good example of how this strategy would be applied. The~     empirical treatment of nosocomial bacteremia by Enterobacteriaceae comprises in several cases~     one or two antibiotics with antipseudomonal activity, being much less common than desirable a~     subsequent change to narrower spectrum antibiotics based on susceptibility data (de~     escalation). This is because the safety of de escalation is based only on expert advice and~     some observational studies, so their efficacy and safety is questioned by many clinicians and~     therefore its use is lower than desired. In fact, a recent systematic review of the Cochrane~     Library concluded that randomized studies to support this practice are needed. Investigators~     propose a real clinical practice-based randomized trial to compare the efficacy and safety~     of continuing with an antipseudomonal agents vs. de-escalation according to a pre-specified~     rule, in patients with bacteraemia due to Enterobacteriaceae.~   "
58899|NCT02795936|"~     This is a study to find out whether cardiac rehabilitation is a program that can work in~     Western Kenya.~      This study will test whether cardiac rehabilitation is feasible by measuring how many~     participants are able to follow and complete two different exercise protocols; one at home~     and one in hospital. It will also measure how the exercise intervention affects quality of~     living, depression and improvement in exercise tolerance.~   "
58900|NCT02795910|"~     This study will evaluate a complex intervention based on a patient management tool (PMT),~     combined with educational outreach to primary care doctors, nurses and other health workers,~     in the Brazilian city of Florianopolis. The intervention is aimed at improving the quality of~     primary health care and health outcomes, in adults with diabetes and cardiovascular disease~     (CVD). The effectiveness of the intervention will be assessed by randomly allocating 48~     primary care clinics to receive the intervention or not, and comparing patient and clinic~     level endpoints that reflect the health and quality of care provided over the following year.~     About 11000 patients known to have been diagnosed with diabetes mellitus and 32000 with CVD~     (defined as having a diagnosis of hypertension, ischemic heart disease, heart failure or~     cerebrovascular disease) in participating clinics will be included in the study. About 7800~     of them have diagnoses of both CVD and stroke. The primary endpoints will be 1. Number of~     participants in whom at least one of the following tests was recorded: body mass index,~     plasma glucose, serum cholesterol, electrocardiogram, and 2. in participants with a diagnosis~     of hypertension recorded previously, average systolic blood pressure recorded. Secondary~     endpoints will include the individual components of the composite scores, health measures~     (hospital admissions and deaths), and indicators of appropriate diagnosis of comorbid~     conditions such as depression. Eligible patients will be identified and outcomes measured~     using electronic medical records.~   "
58901|NCT02795897|"~     The purpose of this study is to look for abnormal genes and gene expression profiles that~     help determine why a person develops amyotrophic lateral sclerosis (ALS) and related motor~     neuron diseases (MND) and why their symptoms present and progress with a particular pattern.~   "
58903|NCT02795871|"~     The classic form of 21-hydroxylase deficiency (prevalence 1/15,000) is the most common cause~     of congenital adrenal hyperplasia (CAH). This autosomic recessive disease is responsible for~     virilization of the external genitalia in girls through androgen hypersecretion during fetal~     life. Since 1984, the Lyon Pediatric Endocrinology group has proposed prenatal dexamethasone~     (DEX) for all fetuses at risk of CAH With the aim of preventing fetal androgen hypersecretion~     in affected girls and avoiding poor long-term results from reconstructive surgery. Prenatal~     DEX was used in Europe and the USA but its use was recently suspended: in 2007, a Swedish~     study conducted on 26 children treated with DEX in utero for a short period of time reported~     cognitive impairments. These data were not confirmed by an American study on the short-term~     DEX use, which showed potential cognitive impairments in CAH children exposed to DEX for long~     periods of time. These confusing and controversial results have caused the scientific~     community to question its position and have resulted in the suspension of the use of prenatal~     DEX with drastic consequences for CAH girls (virilization; genital surgery etc.). In this~     context, an evaluation of neuropsychological development under in utero DEX is essential to~     validate its indication for use during the prenatal period. This study will evaluate outcomes~     using prospective cognitive and emotional assessments. It will first focus on the unaffected~     children previously treated in utero in order to assess the adverse effects of the drug. The~     study will then assess the children with CAH for whom DEX could have beneficial effects.~   "
58904|NCT02795858|"~     This research study is evaluating the drug Ramucirumab as a possible treatment for Advanced,~     Progressive Carcinoid Tumors.~   "
58905|NCT02795845|"~     During pregnancy, bacterial vaginosis (BV), abnormal vaginal flora (AVF) and vulvovaginal~     candidiasis (VVC) are associated with serious complications and discomfort. Yet, treatment~     options are limited. Lactobacilli administration was suggested to treat and prevent vaginal~     infections. However, this has not been examined in pregnant women, the information regarding~     oral treatment is scarce, and the mechanisms in which oral ingestion of probiotics induce~     vaginal lactobacilli proliferation are not well established. In the present study we will~     examine if oral probiotics are effective in prevention of vaginal infections by migration of~     lactobacilli from the digestive system to the vagina in pregnant women.~   "
58906|NCT02795832|"~     A Randomised, Adaptive Design, Double-Blind (3rd Party Open), Placebo Controlled, Sequential~     Group Study to Determine the Safety,Tolerability, Pharmacokinetics and Efficacy of Twice~     Daily Application of a Topical ZPL-5212372 (1.0% w/w) Ointment Administered for up to 2 Weeks~     in Adult Healthy Volunteers and Patients with Moderate to Severe Atopic Dermatitis~   "
58907|NCT02795819|"~     This phase 1 study will identify recommended phase 2 doses (RP2Ds) of AR-42 and pazopanib~     when given in combination for subsequent clinical trials and may potentially identify~     candidate pharmacodynamic and predictive biomarkers.~   "
58908|NCT02795806|"~     Background: Electronic health records contain a vast amount of data about diseases and~     treatments. Researchers could use this data to test their ideas, but they would need to use~     records from more than just their own group of patients. But access to those records is~     restricted to ensure patient privacy.~      U.S. National Library of Medicine (NLM) has created a computer tool called NLM Scrubber. This~     program recognizes and deletes personal information from health records. The researchers who~     developed this program now need access to the original records. This will allow them to see~     how well the program removes personal information from patient records and how they can make~     it more accurate.~      Objectives:~      To find ways to improve clinical text de-identification.~      Eligibility:~      No new participants. Researchers will review data that have already been collected.~      Design:~      Researchers will collect a random sample of reports. These will be from different doctors in~     different fields.~      Researchers will manually remove personal information from the records.~      Researchers will also automatically remove personal information from original records using~     NLM-Scrubber.~      Researchers will compare the results of the computer program versus the manual changes. They~     will note when the program has not been removing personal information correctly. They will~     also note when the program has been deleting nonpersonal health information incorrectly.~      Researchers will use the results to revise the program. They will keep testing it until the~     de-identification process is complete.~   "
58909|NCT02795793|"~     This study is designed to determine the safety and efficacy of non-operative antibiotic~     management of clinically diagnosed acute uncomplicated appendicitis in children. Enrolled~     patients will be randomised and an allocation ratio of 1:1 will be made via weighted~     minimisation, where half of the patients will receive non-operative management with~     intravenous Piperacillin with Tazobactam, while the other half will have an appendicectomy.~   "
58910|NCT02795780|"~     This study will evaluate longitudinal change of tau deposition as measured by 18F-AV-1451~     uptake over time.~   "
58911|NCT02795767|"~     This non-randomized, multicenter, open-label, Phase III clinical study will evaluate the~     efficacy, safety, and pharmacokinetics of emicizumab administered subcutaneously initially~     once weekly (QW) in pediatric participants with hemophilia A with FVIII inhibitors. This~     study will open two additional non-randomized cohorts to investigate Q2W and Q4W regimens in~     pediatric participants.~   "
58912|NCT02795754|"~     GSK2838232 is a Human Immunodeficiency Virus (HIV) maturation inhibitor being developed for~     the treatment of HIV in combination with other antiretroviral therapy (ART). The primary~     objectives of this study are to investigate the safety, tolerability, and pharmacokinetics~     (PK) of single and repeat doses of GSK2838232. This study will be a double-blind,~     placebo-controlled, single and repeat dose escalation study. This study will be conducted in~     two Parts: single escalating doses (Part 1A and 1B), and repeated escalating once daily (QD)~     doses for 11 days (Part 2) of GSK2838232 co-dosed with RTV. During Part 1A, single doses of~     GSK2838232 (as of active pharmaceutical ingredient-powder in bottle [API PiB]) 50 milligrams~     (mg), 100mg and 200mg will be administered with RTV. Part 1B will evaluate the relative~     bioavailability of single doses of crystalline active pharmaceutical ingredient (API)~     Immediate Release Tablet (IR) tablets versus API PiB as reference, administered with RTV. In~     Part 2, multiple doses of GSK2838232 will be co-administered with RTV 100mg QD for 11 days as~     sequential dose cohorts. Maximum duration of study participation will be approximately 10~     weeks.~   "
60333|NCT02777138|"~     The accumulation and dysfunction of excess adipose (fat) tissue that occurs with ageing is~     associated with a number of chronic inflammatory disorders such as type 2 diabetes and~     cardiovascular disease but the underlying mechanisms are not understood.~   "
58913|NCT02795741|"~     The Cooling Bolero is a a vest filled with a new material (not ice or a gel) that provides~     controlled cooling by absorbing heat. The vest is manufactured by Nanohealth. It intended to~     provide moderate cooling (~15C/59F) through indirect contact with the skin. The material in~     the device is safe, non-toxic, and eco-friendly.~      Recent anecdotal studies of women with common peri-menopausal and menopausal symptoms (hot~     flashes, night sweats, flushing/sweating of face and neck, and intermittent sleep~     disturbances) have shown a reduction in both the frequency and intensity of those symptoms~     after using the Cooling Bolero. Specific (moderate) temperature cooling of the neck and upper~     torso appears to target and mitigate these common menopausal symptoms. This pilot study~     attempts to collect additional data on the effects of the Cooling Bolero.~   "
58914|NCT02795728|"~     Purpose: To evaluate the retention and caries preventive effect of the glass-ionomer fissure~     sealants and resin-based fissure sealant. Materials and Methods: Using a split mouth design~     ,a double blind randomized controlled clinical trial was conducted to compare the retention~     and the caries preventive effect of light cure resin base sealant (3M ESPE) and Glass ionomer~     sealant (FUJI). The study comprised of 120 government school children of 7-9 years age group.~     The glass-ionomer sealant and resin-based sealant were applied randomly on either side of the~     first mandibular permanent molars. They were recalled for assessment of sealant retention at~     intervals of 3, 6 and 12 months.~   "
58915|NCT02795715|"~     The aim of this study is to investigate whether a tDCS-accompanied training of audio-visual~     associative memory leads to a performance improvement in healthy older individuals.~   "
58916|NCT02795702|"~     The aim of this study is to investigate whether a tDCS-accompanied training of audio-visual~     associative memory leads to a performance improvement in healthy older individuals.~   "
58917|NCT02795676|"~     This is a randomized, double blind, active control study of PRX-102 (pegunigalsidase alfa) in~     Fabry disease patients with impaired renal function. Patients treated for approximately 1~     year with agalsidase beta and on a stable dose for at least 6 months will be screened and~     then randomized to continue treatment with 1mg/kg agalsidase beta or to treatment with 1~     mg/kg of PRX-102. The identity of the enzyme will be blinded to the patient and the~     investigator. Patients will receive intravenous infusions every two weeks. Patients will be~     randomized in a 2:1 ratio of PRX-102 to agalsidase beta. Randomization will be stratified by~     urinary protein to creatinine ratio (UPCR) of < or ≥ 1 g/g by spot urine sample. No more than~     50% of the patients will be female.~   "
58918|NCT02795663|"~     -  Background : Deep brain stimulation of SubThalamic Nucleus (STN-DBS) is an effective~          treatment for a large variety of movement disorders. However, the efficacy of STN-DBS~          relies on unclear mechanisms.~        -  Purpose: In this study, using optical imaging, the investigators will evaluate the~          cortical hemodynamic changes induced by STN-DBS of parkinsonian patients during motor~          task and delay discounting task. the investigators will perform an optical imaging study~          using Near-InfraRed Spectroscopy (NIRS) in a parkinsonian patient after STN-DBS. The~          investigators will measure bilateral local cortical hemodynamic changes under On and~          Off stimulation conditions and during a motor task (left hand movement) and delay~          discounting task Relative concentration changes of oxy-Hb, deoxy-Hb, and total Hb will~          be continuously analyze.~        -  Primary outcome: Study of local cortical hemodynamic change (oxy-Hb, deoxy-Hb, and total~          Hb) under  on  and  off  stimulation during a motor task.~   "
58919|NCT02795650|"~     This is a multicenter, open label, randomised phase II clinical trial for patients with~     metastatic adenocarcinoma of the pancreas. Patients randomised to the experimental arm will~     undergone tumoral biopsy before starting first line of treatment and will be administered~     personalised therapy as second or third line.~   "
58920|NCT02795637|"~     Study of the what the body does to the drug in subjects with mild, moderate, and sever liver~     dysfunction (not working properly)~   "
58921|NCT02795624|"~     Specific Aim 1. Characterize the long-term effects of secondhand smoke (SHS) on vascular~     health in pre-ban flight attendants (FAs). Investigators will measure arterial stiffness~     (pulse wave velocity and augmentation index) and endothelial dysfunction (reactive hyperemia~     index) in the pre-ban FA cases, and compare to the cardiovascular risk-factor matched~     Framingham controls.~      It is hypothesized that pre-ban FA cases have increased arterial stiffness (higher pulse wave~     velocity and higher augmentation index) and increased endothelial dysfunction (lower reactive~     hyperemia index) compared to Framingham controls.~      Specific Aim 2. Determine the extent in which remote pre-ban SHS exposure (hours) is~     associated with increased arterial stiffness or endothelial dysfunction.~      Investigators hypothesize that pre-ban SHS exposure is positively associated with both~     increased arterial stiffness and increased endothelial dysfunction.~      Specific Aim 3. Investigators will calculate the cardiovascular risk scores (Framingham,~     Reynolds, and ASCVD) by using subjects' age, blood pressure, family history, lipid panel, and~     highly sensitive C-reactive protein. Investigators will explore the association of the risk~     scores with measures of vascular aging (arterial stiffness and endothelial dysfunction).~     These scores do not include SHS exposure. Investigators will also test the additive value of~     SHS exposure in increasing arterial stiffness and endothelial dysfunction using the risk~     scores as an adjustment value.~      It is hypothesized that the cardiovascular risk scores are associated with vascular aging~     (arterial stiffness and endothelial dysfunction), and that the association between SHS~     exposure and vascular aging remains significant after adjusting for the cardiovascular risk~     scores.~      The significance of this proposal and impact will be (1) mechanistic insights into how remote~     SHS exposure leads to hypertension and vascular stiffness, (2) increased understanding of how~     SHS exposure can increase risk of cardiovascular disease, which is the number one cause of~     death in the United States.~   "
58922|NCT02795611|"~     Play skills and participation of children with Autism Spectrum Disorder (ASD) have been~     restricted by their core symptoms, resulting in heightened parenting stress and affected~     family daily life. This research aims to improve play skills and participation of children~     with ASD through 'family-centered occupational therapy', thereby leading to positive outcome~     for not only the child but also the whole family.~   "
58923|NCT02795598|"~     The investigators plan to determine the incidence of hemi-diaphragmatic paresis (HDP) with~     two commonly used techniques of supraclavicular nerve block, the single and double injection~     techniques.~      It is our hypothesis that a double injection peripheral nerve block technique will increase~     the risk of HDP when compared to a single injection technique.~   "
58924|NCT02795585|"~     Quantitative Flow Ratio (QFR) is a new method for evaluating the functional significance of~     coronary stenosis by calculation of the pressure in the vessel based on two angiographic~     projections. The purpose of the WIFI study is to evaluate feasibility of QFR when performed~     during coronary angiography and compare diagnostic accuracy to standard FFR.~   "
58925|NCT02795572|"~     The trial will utilize Nutraceuticals (Vitamin D 2000IU oral once daily, Vitamin B6 100 mg~     oral once daily, Vitamin B12 100 mcg oral once daily, Omega-3 Fatty Acids 900 mg oral three~     times a day) in patients treated with Docetacel as Neoadjuvant or Adjuvant Breast cancer~     Therapy. The trial is being conducted to see if the use of Nutraceuticals will prevent or~     reduce Chemotherapy Induced Peripheral Neuropathy (CIPN).~   "
58926|NCT02795559|"~     It has been suggested that obesity occurs because the colonic microbes in obese individuals,~     compared to those who are lean, produce more short chain fatty acids during the fermentation~     of dietary fiber; this means that obese individuals obtain more energy from dietary fiber~     than lean. On the other hand, it is possible that the ability of colonic short chain fatty~     acids to improve glycemic control and suppress appetite may be reduced in obese subjects. The~     aim of this study was to determine the acute effects of 2 fibers commonly used as food~     ingredients, inulin and resistant starch, on postprandial serum responses of short chain~     fatty acids, glucose, insulin, free-fatty acids and selected gut hormones in lean and~     overweight or obese subjects.~   "
58927|NCT02795546|"~     The aim of the present study was to evaluate the bone formation potential of 400µg~     alendronate delivered in β-TCP in the treatment of periodontal intra-osseous defects.~   "
58928|NCT02795533|"~     The current study is a continuation of the study Effect of early rehabilitation in patients~     with acute aSAH which was approved by the Regional Committee for Medical Research Ethics,~     South-East Norway, archive number 2011/2189, Clinical Trials number 0925-0586 (Clinical~     Trials gov. identifier NCT01656317). The original study was a prospective, controlled,~     interventional study comprising patients managed at the neuro-intermediate ward following~     repair of a ruptured intracranial aneurysm in 2011-2012. 157 patients signed the informed~     consent form and were included in the study. Patients were assessed in the acute phase, as~     well as a 3 and 12 months post ictus. The main research goal of the present study will be to~     assess physical, cognitive and emotional function 5 and 10 years after aSAH in the 2011-2012~     population. In addition we will also describe quality of life and work-status along with the~     time-course of recovery from the acute sage after aSAH to the chronic phase.~   "
58929|NCT02795520|"~     The purpose of Phase I of this study is to test the safety and tolerability of the~     investigational drug, OTS167, and that of Phase II of this study is to confirm the potential~     response benefit of OTS167.~      OTS167 is a maternal embryonic leucine zipper kinase (MELK) inhibitor which demonstrated~     antitumor properties in laboratory tests. It is being developed as an anti-cancer drug. In~     this study OTS167 will be administrated to patients with AML, ALL, advanced MDSs, advanced~     MPNs, or advanced CML.~   "
58930|NCT02795507|"~     The purpose of this study is to investigate the effects of training of the non-involved upper~     limb on the motor ability of the hemiparetic upper limb in patients with unilateral~     sensorimotor motor impairments. The secondary aims are to investigate the relation between~     lesion characteristics and responsiveness to the treatment, and to study which brain~     structures are activated during a task trained in the treatment.~   "
58931|NCT02795494|"~     Patient oriented clinical outcomes have increased in use and popularity and provide a~     comprehensive assessment of the level of symptoms and function experienced by a patient.~     Though several measures have been developed and shown to be valid, reliable, and responsive~     in adults, such efforts have only been rarely undertaken in pediatric populations.~     Specifically, there has been no validation of the predominant adult hip specific outcome~     measures, such as the WOMAC and Oxford-12, in children and adolescents. Prior to using such~     measures in pediatric patients, it is necessary to establish the psychometric properties of~     these measurements in this population.~      The objective of this study is to determine the reliability and validity of the WOMAC hip~     scores in a pediatric population, between five and nineteen years of age, with Perthes~     disease. The results of this study will accomplish the above goal, thereby allowing either~     for widespread use of these measures in pediatric hip disorders or emphasizing the necessity~     for development of a pediatric hip specific outcome measure.~   "
58932|NCT02795481|"~     Stroke is one of the leading causes of death and disability in the UK and currently costs the~     country £7bn per year. There is an overwhelming need to accurately and rapidly triage~     patients to allow best use of finite NHS specialist resources for the treatment of stroke.~      A simple blood test of substances (the purines) that result from cellular metabolism and are~     produced in excess when brain cells are starved of oxygen and glucose (as occurs during a~     stroke) is proposed. The sensors designed by the investigators are used to measure blood~     purines during a procedure in which blood flow to the brain is reduced to allow surgical~     interventions on the major arteries that supply the brain. Previous studies by the~     investigators have shown that as soon as blood flow to the brain is reduced, purines are~     produced within minutes and are detectable in systemic arterial blood.~      The current project will now compare the levels of purines in the blood of stroke patients~     and controls. The purines will be measured on admission to hospital and 24 hours later. The~     occurrence and magnitude of a stroke will be determined by an MRI scan given between 24 and~     72hrs after admission. This study will establish whether purines are elevated in the blood of~     stroke patients on admission to hospital compared to healthy controls, and whether this~     correlates with the size of the stroke and damage to the brain.~   "
58933|NCT02795468|"~     The investigators are trying to compare the ultrasound-guided technique vs. palpation method~     for radial arterial cannulation in infants.~   "
58934|NCT02795455|"~     The researchers plan to explore brain networks involved in emotion processing and learning~     using a brain scan and test meals. One core feature of Anorexia Nervosa (AN) is eating a~     small number of high-calorie or high-fat foods. By studying why individuals with AN are~     disgusted by food or other eating situations, the researchers will be able to understand more~     about the neurobiological pathways that lead to restricting food intake and food avoidance.~     This study also aims to find whether one of two short-term interventions (Interoceptive~     Exposure (IE); Family-Based Therapy (FBT)) affects connections in the brain and if the~     treatments affect food avoidance. IE is an intervention that helps reduce anxiety about~     eating. FBT is an intervention that motivates patients to eat through working with family to~     increase the value of eating and decrease the value of avoiding foods.~   "
58935|NCT02795442|"~     The purpose of this study is to determine if when one eats protein can change how the body~     uses food for energy. Researchers will also test if eating a high protein breakfast can~     change one's craving for snack foods.~   "
58936|NCT02795429|"~     The purpose of this study of INC280 and PDR001 is to characterize the safety, tolerability,~     pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of PDR001 administered~     i.v. as a single agent or in combination with INC280 administered orally in adult patients~     with advanced hepatocellular carcinoma (HCC).~   "
58937|NCT02795416|"~     Secukinumab targets a different interleukin and has potential to be used as alternative to~     existing treatments. This study will provide clinical data with respect to efficacy through~     Psoriasis Area and Severity Index (PASI) at 16 weeks, safety/tolerability of secukinumab and~     evaluate the impact of the treatment on quality of life and work productivity in subjects~     with moderate to severe plaque psoriasis in the Turkish population.~   "
58938|NCT02795403|"~     The emergence of hepatocellular carcinoma (HCC) has prompted a search for a thorough~     understanding of the biology of one of its major causative agents, the hepatitis C virus~     (HCV). HCV particles acquire via budding and encapsidation cellular proteins. There is~     mounting evidence on several viral species that virion-bound proteins are prone to be~     involved either at the replication, budding/egress or entry/release steps of the viral cycle.~      Identifying such targets may yield ideal candidates for gaining insight on the dependence of~     HCV upon a restricted subset of host proteins, therefore providing refined sets of~     genetically stable targets for therapy. This project's goals are to set up adequate~     conditions for robust and reproducible purification of HCV virions in clinical samples,~     followed by the identification of their HCV-bound host proteins and the characterization of~     their functions. Proteomics profiling of HCV particles purified from clinical samples will be~     overlaid with proteins identified and characterized in cell culture grown HCV particles~     during my post-doctoral training, using clinical biomarker discovery grade criteria. Targets~     identified in both samples sets will be subjected to in vitro investigations using~     HCV-replicating cells. Conventional biochemical and imaging methods will be used in order to:~     (i) ascertain their physical association with HCV virions; (ii) define the modalities of~     their interaction with HCV proteins; (iii) decipher the topology and subcellular localization~     of their association with HCV proteins and virions; (iv) quantitatively assess their~     functional involvement in particle budding, egress or secretion and infectivity. A candidate~     that yielded satisfactory results in these experiments will be disclosed and further~     investigated at the level of structural biology, in collaborative research programs.~   "
58939|NCT02795390|"~     It is a double-blinded, randomized, placebo-controlled trial for advanced cancer patients~     with constipation. 60 patients will be randomly assigned to have individualized herbal~     intervention (treatment group) or placebo (control group) in 1:1 ratio. For the treatment~     group, MaZiRenWan 10g plus HuangQi 20g are chosen as the core prescription. Furthermore, six~     herbal granules can be added according to the syndrome differentiated for individual~     participant. Placebo is made from dextrin (76.03%), tea essence (23.61%), gardenin (0.02%),~     and caramel (0.34%) to achieve color, smell, taste, and texture comparable to the herbal~     granules. Patients are instructed to dissolve the granules in 150ml of hot water, twice daily~     for two weeks. The primary end point is the global symptom improvement. Secondary outcome~     measures include stool frequency, stool form, use of rescue herbal granules, constipation~     visual analogue scale (CVAS) (0=none to 7=most severe) and individual assessment of~     constipation related symptoms. For the safety profiles of herbal intervention, the important~     adverse events reported and clinical laboratory evaluations of liver and renal function are~     determined.~   "
58940|NCT02795377|"~     Membrane microparticles are submicron fragments of membrane vesicles shed from various cell~     types. Circulating endothelial microparticles have been proposed as markers of endothelial~     injury. However, which mechanical forces contribute to their release is not clear.~   "
58941|NCT02795364|"~     Gliomas,especially high-grade glioma ,are the most common primary malignant brain tumor in~     adults,yet outcomes from this aggressive neoplasm remain dismal.The extent of resection is~     one of the most essential factors that influence the outcomes of glioma resection.However,~     conventional structural imaging has failed to accurately delineate glioma margins because of~     tumor cell infiltration. the investigators have finished few project that suggest the~     feasibility of Magnetic Resonance Spectrum(MRS)-guided resection,unfortunately, lacking~     sufficient clinical evidence.This prospective cohort study is to provide a clinical evidence~     for the validity of MRS-guided resection in patients with HGG .~   "
58942|NCT02795351|"~     In a double blind placebo-controlled cross-over study the effect of Sildenafil on aura and~     migraine headache induction is tested in patient with migraine with aura.~   "
58943|NCT02795338|"~     It is unknown whether imaging technologies have broad applications in brain mapping due to~     limited knowledge of the value of the results. Accurate identification of areas of eloquent~     brain function is vital to surgical decision making and to preservation of independence as~     patients with brain tumors who are higher functioning have better survival outcomes. Imaging~     technology has evolved to provide multiple non-invasive modalities for pre-operative testing~     of eloquent brain function and include functional MRI (fMRI) and magnetoencephalography~     (MEG). Eloquent brain is defined as a region controlling language, motor, or sensory function~     such that without its proper input, a person would be left with significant neurologic~     deficits.~      Studies conducted by our group and others have shown that these non-invasive mapping~     modalities provide useful information, however, the information provided inconsistently~     predicts distribution of eloquent function.~      Direct electrical stimulation (DES) at the time of surgery allows assessment of eloquent~     function directly from the brain surface (invasive) and is considered the gold standard in~     brain mapping. Therefore, in order to determine the true clinical applicability of the~     non-invasive mapping technologies, we propose to: (1) assess the predictive value of fMRI and~     MEG for sensorimotor and language functions by comparing their results to DES and (2)~     determine whether fMRI or MEG provides the most consistent and accurate information. We will~     accomplish these Aims by co-registering all mapping data (invasive and non-invasive) in a~     modifiable 3D rendering. In this way, we can evaluate the DES to fMRI and MEG as well as~     compare fMRI to MEG. The rationale for the proposed research is that understanding the~     reliability of our current technology will allow us to perform safer surgeries and to~     preserve neurologic function. The expected outcomes for the work proposed in Aims 1 and 2 are~     identification of a predictive value for fMRI and MEG and determination if one modality~     should be utilized over the other pre-operatively for the most accurate information. The~     results of this study are expected to have an important positive impact because~     identification of accurate pre-operative non-invasive mapping modalities will allow tailored~     testing and possibly lead to negation of the need for intra-operative mapping in certain~     cases. It will also enhance patient outcomes by improving patient safety. Furthermore, it~     will serve as the basis for a multi-institutional mapping data bank.~   "
58944|NCT02795325|"~     A phase 1 study of DCR-PH1 in patients with primary hyperoxaluria type 1 (PH1) to determine~     the safety, tolerability, pharmacokinetic (PK) and pharmacodynamics (PD) effects of DCR-PH1~     administered via-intravenous infusion (IV)~   "
58945|NCT02795312|"~     This is a study designed to mindfulness based stress reduction (MBSR) training program to~     assess feasibility and acceptability of the intervention. Participants will participate in a~     9-week training program and complete pre-and post-questionnaires. Participants will have the~     option of participating in a follow-up focus group.~   "
58946|NCT02795299|"~     Phase 2 Study Evaluating Gerilimzumab's Safety/Efficacy for Patients with an Inadequate~     Response to MTX or a TNFα Antagonist in Rheumatoid Arthritis.~   "
58947|NCT02795286|"~     The ASIST study is a medical device study testing the safety and efficacy of a new~     hemodialysis machine software in chronic haemodialysis patients. The software's intention is~     to reduce hemodialysis related symptoms such as unwell being, blood pressure changes by~     adapting the dialysis fluid ion concentration to the patients plasma ion concentration by~     conductivity measurement.~   "
58948|NCT02795273|"~     The purpose of this study is to evaluate the safety of Grass-SPIRE compared with placebo and~     to evaluate the treatment effect of Grass-SPIRE on symptoms and use of rescue medication~     during the grass pollen season~   "
58949|NCT02795260|"~     The investigators recruit about 1800 cases participants who has signed ICF,then do some~     physical examinations for these people, including ecg, X-ray, HIV,blood pressure, specific~     gamma-interferon detection ,collection of medical history and the like .These subjects who~     meet the standard are considered as study population I. Population I are injected~     intradermally with ESAT6-CFP10 and Tuberculin purified protein derivative(TB-PPD) at~     different arm of the same subject and get at least 360 participants whose three kinds of~     detection result are all negative and are considered as study population II.Then,they are~     immune to the Bacillus Calmette -Guerin(BCG) vaccine or the placebo of the BCG.Do specific~     gamma-interferon detection before the skin test,then inject intradermally with ESAT6-CFP10~     and TB-PPD at different arm of the same subject 12 weeks after immunity.~   "
58950|NCT02795247|"~     The purpose of this study is to compare the tomographic results of patients who underwent~     single-bundle anterior cruciate ligament reconstruction at the investigator's institution~     using the transtibial, accessory medial portal technique and the modified transtibial~     technique to determine which technique best recreates the anterior cruciate ligament anatomic~     footprint.~   "
58951|NCT02795234|"~     The aim of this study is to detect antibodies to vitamin D in the serum at Different Groups~     of patients and healthy volunteer. A second goal is to find the relation between Vitamin D~     Antibody and Vitamin D level.~   "
58952|NCT02795221|"~     Systemic sclerosis (SSc) is multisystem autoimmune disease of unknown etiology. It's~     characterized by activation of immune system, microvascular changes and intimal~     proliferation.~      The EULAR/ACR 2013 criteria for the classification of SSc will help identify SSC patients~     before fibrosis of internal organs and will allow early treatment.~      Patient with RP, SSc-related autoAb, anti-topoisomerase I (SCL-70), anti-centromere autoAb,~     anti-RNApolymerase III, abnormal nailfold capillaries and puffy hands would have SSc.~      The OR of abnormal capillaroscopy for subsequent development of SSc can reach 163 with~     positive predictive value of 52% and negative predictive value of 99% .Some studies found~     that preclinical internal organ involvement in pre-scleroderma patients, DLCO<80% was~     detected in 11/32 patients with RP plus SSc-associated autoAb plus SSc-type nailfold~     capillary changes.~      The heritability of SSc was considered controversial in the, largest published SSc .Twin~     study, which in general suggested a modest genetic contribution to the Phenotype~     .Nevertheless, this study included only 42 sets of twins, and it should Be considered that,~     in a family study of 703 cases, an affected first-degree relative Increased the risk of SSc~     13 times compared to the general population . Moreover, having an affected sibling increased~     SSc risk by 15 times , and there Was a remarkable concordance of auto antibodies between SSc~     twins . Additionally, recent analyses have shown that the standardized incidence ratio of SSc~     seemed to be less than those observed in autoimmune diseases (ADs) such as Rheumatoid~     arthritis or Ankylosing Spondylitis, but similar to those observed for Hashimoto, thyroiditis~     or psoriasis. In addition, SSc prevalence, clinical Outcomes and autoantibody profiles have~     been reported to vary depending on Patient ancestry Therefore, the role of genetic factors in~     SSc susceptibility can now be considered solidly established.~      A positive family history of SSc appears to confer a risk that is at least 10-16-fold Higher~     than normal for SSc in first-degree relatives and 10-27-fold higher than Normal for SSc in~     siblings, and thus represents the strongest susceptibility factor Yet reported for this~     disease .~   "
58953|NCT02795208|"~     This study test whether a lung recruitment maneuver improves the right ventricle performance~     after cardiopulmonary bypass. Half of the patients received an standard protective~     ventilation and the other half the same ventilatory pattern after a lung recruitment~     maneuver.~   "
58954|NCT02795195|"~     The purpose of this study is to determine the maximal tolerated dose (MTD) of re-irradiation~     using carbon ion radiotherapy (CIRT) with the fraction size of 3 GyE in the treatment of~     locally recurrent nasopharyngeal cancer (NPC) and to evaluate the efficacy of such treatment~     at the MTD. Participants will be treated with CIRT with escalating dose regimens to evaluate~     the maximal tolerated dose (MTD) in terms of acute and subactue toxicity observed during and~     within 4 months after the completion of CIRT. Once the MTD for locally recurrent NPC is~     determined, the MTD will be used as the recommended dose to patients fulfilling the inclusion~     criteria in the Phase II part of the trial.~   "
58955|NCT02795182|"~     This study is evaluating the safety and preliminary efficacy of BGB-3111 in combination with~     BGB-A317 in subjects with B-cell lymphoid malignancies.~   "
58956|NCT02795156|"~     With the increased availability of next-generation sequencing, oncologists are starting to~     incorporate genomic profiling into routine care of cancer patients. If a genomic alteration~     is identified during profiling, it could help guide the choice of therapy and improve~     treatment outcomes. This study will examine the anti-tumor activity of selected commercially~     available molecularly matched targeted therapies in patients who have failed first-line~     treatment for one of the following tumor types: non-small cell lung cancers; urothelial~     cancer; non-colon gastrointestinal cancers, and upper aerodigestive tract cancer.~   "
58957|NCT02795143|"~     The purpose of this study is to determine whether isotretinoin is helpful in treating~     patients with an adverse cutaneous drug eruption known as toxic epidermal necrolysis (TEN).~   "
58958|NCT02795130|"~     Small-incision vitrectomy techniques have become increasingly popular, with a number of~     advantages over the older 20-gauge instrumentation. The beveled wounds created by the 23- and~     25-gauge trocar systems theoretically do not require sutured closure. However, a certain~     fraction of cases, 1% for 25-gauge systems, and 4-38% for 23-gauge systems, do require suture~     placement. Poor wound closure puts the patient at increased risk of post-operative hypotony~     and is associated with increased risk of endophthalmitis. Currently, surgeons are divided as~     to which suture is the best for sclerotomy closure. The current standard of care is 8-0~     polyglactin 910 (Vicryl, Ethicon, Cincinnati, OH). This suture is soft and easy to work with;~     however, it triggers a robust inflammatory response. The alternative is 6-0 plain gut suture,~     which is more difficult to manipulate and thicker, but causes less tissue inflammation1. The~     purpose of this study is to prospectively evaluate these two options for sclerotomy closure.~     The results of this study will enable us to minimize patients' post-operative discomfort~     while maximizing safety outcomes.~   "
58959|NCT02795117|"~     The purpose of this study is to compare the safety and efficacy of Perrigo's product to an~     FDA approved product for the treatment of inflammatory lesions rosacea~   "
58960|NCT02795104|"~     This randomized clinical trial studies how well a tailored interactive digital versatile disc~     (DVD) with or without patient navigation works in improving screening rates in rural women~     for breast cancer, cervical cancer or colorectal cancer. A tailored interactive DVD and~     patient navigation may help rural women to learn more about cancer screening and to better~     understand the results.~   "
59163|NCT02792465|"~     This is a phase 1 study of investigational agent CFI-402257 in patients with advanced cancer.~     The purpose of this study is to see how safe and tolerable CFI-402257 is in cancer patients~     as well as the pharmacokinetics (PK). This study is the first time that CFI-402257 is given~     to humans.~   "
58961|NCT02795091|"~     Multidrug resistance bacteria infection is common in ICU. Infection incidence is associated~     with age, organ dysfunction, invasive treatment and enviroment cleaning. According to~     hospital hygienic standard for disinfection, total numbers of colony of air and the object~     surface in ICU must be ≤4CFU/cm2（5min）and≤10CFU/cm2. in this study, the two different methods~     will be used to evaluate the disinfection effects in ICU enviroments.~   "
58962|NCT02795078|"~     Atherosclerotic intracranial arterial（ICA） stenosis and intracranial aneurysms are the common~     causes of ischemic stroke and hemorrhagic stroke, respectively. Investigators aimed to assess~     the prevalence of cerebral aneurysms in patients with atherosclerotic intracranial arterial~     stenosis.~   "
58963|NCT02795065|"~     The purpose of this study is to compare two types of low-molecular-weight heparin, enoxaparin~     and bemiparin, as regards their efficacy and safety in venous thromboembolism prevention~     among intensive care unit patients.~   "
58964|NCT02795052|"~     This is a human clinical study involving the isolation of autologous bone marrow derived stem~     cells (BMSC) and transfer to the vascular system and inferior 1/3 of the nasal passages in~     order to determine if such a treatment will provide improvement in neurologic function for~     patients with certain neurologic conditions. http://mdstemcells.com/nest/~   "
58965|NCT02795039|"~     The purpose of this study is to demonstrate bioequivalence between the test drug product,~     fulvestrant Injection, 50 mg/mL, and the Reference Listed Drug, Faslodex® Injection, 50~     mg/mL.~   "
58966|NCT02795026|"~     Chronic Pelvic Pain (CPP) are around 10% of gynaecology referrals.Non-relaxing pelvic floor~     dysfunction (NRPFD) is an under-appreciated cause for CPP with dyspareunia where no other~     pathology exists. The effectiveness of manual therapy in studies have shown statistically~     significant pre and post treatment differences.However no study has reviewed the efficacy of~     inclusion of trans- perineal trigger point dry needling used with manual therapy for NRPFD.~     This study will investigate the effectiveness of trans-perineal trigger point dry needling~     used with manual therapy techniques for CPP.~   "
58967|NCT02795013|"~     Hodgkin lymphoma (HL) is a relatively rare disorder with known familiar aggregation (i.e. HL~     in more than one child, or parent and child). Because affected individuals in familial HL are~     genetically related, the existence of such families has long been considered as evidence in~     support of a genetic basis of HL susceptibility. However, it is largely unknown which genetic~     variations are responsible for recurring HL in families. Because the effects of genetic~     variants are likely to be strong in familial HL, identification of such variations will~     potentially reveal biological pathways critical to the pathogenesis of HL.~      PRIMARY OBJECTIVE:~        -  To perform genome-wide sequencing of families with recurring Hodgkin lymphoma cases~          (affected as well as non-affected family members) to identify potential disease-causing~          germline genetic variations.~      SECONDARY OBJECTIVE:~        -  To describe demographic and clinical features of the affected families.~   "
58968|NCT02795000|"~     The purpose of this research is to develop a predictive nomogram for primary ovarian~     insufficiency.~   "
58969|NCT02794987|"~     Endoscopic retrograde cholangio-pancreatography (ERCP) is a diagnostic and therapeutic~     procedure, however it has an important image limitation. The fluoroscopic cholangiography~     shows the biliary tree in a two-dimensional view. When an indeterminate biliary stricture is~     seen, the certainly diagnosis by ERCP depends on a blind biopsy sampling with the risk of~     missed pathology and sampling errors. SpyGlass® System (Boston Scientific, Marlborough,~     Massachusetts, USA) is a cholangioscope that enables single-operator, direct visualization of~     the pancreatico-biliary system and the evaluation of intraductal lesions. It has a digital~     sensor with 4x resolution and a 1.2 mm working channel that allows the passage of the~     SpyBite® Forceps biopsy. It has been demonstrated that the use of SpyGlass® System and~     SpyBite® Forceps changes clinical management in 64% of patients. It has a sensitivity of~     76.5% for indeterminate stricture diagnosis, compared to 29.4% and 5.9% sensitivity using~     blind biopsy brushing catheter respectively. Although it has been described before~     cholangioscopic images of malignant biliary lesions like an irregular lesion surface with~     irregular vessels and bleeding or a smooth surface without vessels for benign lesions, there~     is no current validated classification that allows unify the diagnostic criteria.~      Methods: Study design: The study was design to be performed in 2 stages. Stage 1:~     observational, retrospective study with case collection from September 2013 to September~     2015. Patients included had bile duct tissular lesion detected by POCS. The images were~     correlated to histopathology and 6 month follows up and a classification was finally~     performed to differentiate benign forma malignant bile duct lesions. Stage 2: patients with~     bile duct tissular lesion detected by POCS, will be the evaluated in a prospective,~     non-randomized and double blind manner. Two groups of endoscopist will evaluate the images~     but only one group will do it using the classification previously performed. Second stage~     case collection has already started (December 2015) and will include patients until December~     2016.~        -  Endpoint Classification: Efficacy~        -  Intervention Model: Non interventional~        -  Primary Purpose: Diagnosis~   "
58970|NCT02794974|"~     The investigators test with the present study design, whether an ultrasound-guided blockade~     of the cervical plexus in combination with an additional application of local anesthetic to~     the superficial cervical ansa (facial nerve: cervical branch) leads to an improved quality of~     anesthesia.~   "
58971|NCT02794961|"~     CD19 expression on B cell frequently lost after CD19-targeting CAR-T therapy. In present~     study, we construct a CD22-targeting chimeric antigen receptor to overcome this issue.~   "
58972|NCT02794948|"~     The purpose of this research is providing valuable traditional chinese medicine theory and~     formula in treating Primary Ovarian insufficiency.~   "
58973|NCT02794935|"~     This research aims to evaluate the effects of inspiratory muscle training (IMT) on apnea~     hypopnea index, sleepiness, sleep quality, cognitive function, motor task, executive~     function, quality of life, chemoreflex sensitivity and vagal modulation of heart rate in~     patients with heart failure and obstructive sleep apnea syndrome.~   "
58974|NCT02794922|"~     The purpose of this study is to determine effectiveness of vitamin B in reducing~     temporomandibular joint disorder (TMD) pain. Patients will be randomised to receive the study~     drug or placebo. The study drug we are using is a combination of vitamin B1(thiamine~     mononitrate)-242.5mg; vitamin B6(pyridoxineHCl)-250mg, and vitamin B12(cyanocobalamin)-1mg.~     We will assess patient's pain level, range of jaw movement and record any side effects from~     using this medication.~   "
58975|NCT02794909|"~     The proposed study is a prospective cohort study in which a select group of emergency~     physicians at Komfo Anokye Teaching Hospital (KATH) in Ghana will be trained in~     cardiopulmonary ultrasound (CPUS). Following the training, patients who present to the ED~     with undifferentiated shock and/or dyspnea will either receive usual and customary care~     supplemented with cardiopulmonary ultrasonography-guided diagnosis and treatment during their~     initial resuscitation, or usual and customary care alone depending on whether the treating~     physician has received CPUS training. The main outcomes is the impact of CPUS on correct~     diagnosis. Information regarding initial treatment strategies, diagnoses and 24-hour~     mortality will be collected via manual review of paper charts and medical records.~   "
58976|NCT02794896|"~     Anesthesia depth affects the proliferation of lymphocytes to NK-cells and memory T-cells~     effect and the phagocytosis activity of macrophages in healthy patients. ASA 1-3 subjects~     undergoing extended shoulder surgery under continuous regional anesthesia randomly were~     assigned to a deep or a shallow anesthesia level (BIS <35 or >55) for more than an hour.~     Immune response is measured by lymphocyte proliferation as well as neutrophil and monocyte~     phagocytosis activity.~   "
58977|NCT02794883|"~     The main purpose of this trial is to investigate the effects of a new class of drugs that~     help the patient's immune system attack their tumor (glioblastoma multiforme - GBM). These~     drugs have already shown benefit in some other cancer types and are now being explored in~     GBM. Both tremelimumab and durvalumab (MEDI4736) are investigational drugs, which means~     that the drugs are not approved by the Food and Drug Administration (FDA). Both drugs are~     antibodies (proteins used by the immune system to fight infections and cancers). Durvalumab~     attaches to a protein in tumors called PD-L1. It may prevent cancer growth by helping certain~     blood cells of the immune system get rid of the tumor. Tremelimumab stimulates (wakes up) the~     immune system to attack the tumor by inhibiting a protein molecule called CTLA-4 on immune~     cells. Combining the actions of these drugs may result in better treatment options for~     patients with glioblastoma.~   "
58978|NCT02794870|"~     The purpose of this study is to evaluate the safety, infectivity, and immunogenicity of a~     single dose of a recombinant live-attenuated respiratory syncytial virus (RSV) vaccine in~     RSV-seronegative infants 6 to 24 months of age.~      This study is a companion study to CIR 311.~   "
58979|NCT02794857|"~     This study evaluates NP001 in patients with amyotrophic lateral sclerosis (ALS) and evidence~     of systemic inflammation. Half of participants will receive NP001 and the other half will~     receive placebo.~   "
58980|NCT02794844|"~     Using genetic information about the individual to pick the right drug for the right disease~     at the right dose defines personalized medicine. This pilot study seeks to institute~     pharmacogenomic testing, that is identifying genetic variation that influences patient~     response to drugs, into the Nemours Children's Health system. We propose to initiate the~     study by identifying genetic differences in cyp2c19, a gene that is responsible for a certain~     enzyme in the liver that metabolizes many drugs including a class of drugs called proton pump~     inhibitors (ppi; Prevacid, Nexium). PPIs are used to treat heartburn and other symptoms of~     gastroesophageal reflux disease (gerd) and are extensively used in pediatrics. Chronic use of~     PPIs can cause serious side effects including cold, pneumonia and stomach infections, which~     gets worse at higher doses. Children who poorly metabolize drugs because of genetic variation~     in cyp2c19 should get lower doses of PPIs than children who metabolize PPIs normally. Our~     pilot study will genotype children with gerd or other stomach acid mediated conditions for~     which a PPI is prescribed using a sample of spit to determine which dose of PPI they get~     based on the form of the cyp2c19 gene they have. We will study 120 children 2-17 yo diagnosed~     with gastroesophageal reflux disease (gerd) or other stomach acid mediated conditions for~     which a ppi is prescribed . Genetic results are available in < 60 minutes, and their doses~     are determined by their doctor based on genetic results. This study will allow us to gain~     valuable experience that will be used to expand our genetic program to other genes and drugs.~   "
58981|NCT02794831|"~     -  NSAIDs are widely consumed, and some are currently available for self-medication with~          indications 'Pain and Fever' (Cavalié, National Agency for Drug Safety (ANSM), 2014)~        -  There is no recommendation to limit their use in bacterial infections except for chicken~          pox in children.~        -  To date, no study has highlighted the aggravating role of exposure to NSAIDs on~          bacterial infections in adults, based on the usual septic severity Levy's score (SSS),~          and mortality, but it delays adequate antibiotics (Legras, Critical Care, 2009)~        -  Community-acquired bacterial infections in adults exposed to NSAIDs are serious by their~          spread (multiple locations), and suppurative character requiring frequent use of~          invasive procedures such as surgery or drainage. The SSS does not reflect the~          seriousness of these infections. They are frequently associated with use of ibuprofen~          (63.4%), and self-medication practices (65.5%).~      The main hypothesis is that NSAIDs exposure is associated with a specific severity of~     community-acquired bacterial infection, marked by dissemination, suppurative complications or~     even invasive procedures requirement.~      Our objectives are also to:~        -  Describe what NSAID use terms are associated to the risk of serious bacterial~          infections: molecule, dosage, duration of exposure, access (prescription or~          self-medication), associated drugs.~        -  To determine what type (s) (s) of bacterial infection is worsened by exposure to NSAIDs.~        -  To determine if other risk factors contribute to severity of bacterial community~          acquired infection~        -  To describe hospital costs associated to such severity of bacterial infection~   "
58982|NCT02794818|"~     To provide prescriptions for weekly Community Supported Agriculture (CSA) boxes of fruits~     and vegetables to patients, accompanied by nutritional education (e.g. printed newsletters~     and YouTube videos), and evaluate benefits for participants by exploring commitment to the~     program, opinions about healthy eating, retention of nutrition and food preparation~     knowledge, overall takeaway from the program, as well as self-assessment of health status.~      To establish the overall feasibility of an effective prescription produce program for~     at-risk and underserved patients - called ProduceRx - by utilizing produce from regional~     farms in addition to the resources of the Penn State Health System and an interdisciplinary~     team of healthcare workers (dietitians, dietetic interns, and medical students).~      To provide a proof-of-concept for this model (i.e. ProduceRx + interdisciplinary approach to~     health education) for other healthcare institutions.~   "
58983|NCT02794805|"~     An Octanoate breath test will be used to assess the presence of Hepatocellular Carcinoma in~     subjects with risk. The gold standard will be MRI.~   "
58984|NCT02794792|"~     The main purpose of this study is to evaluate the efficacy in reducing glycated hemoglobin of~     ipragliflozin in combination with metformin compared with metformin plus placebo in subjects~     with type 2 diabetes mellitus who have inadequate glycemic control on metformin.~   "
58996|NCT02794636|"~     The primary objective of this study is to quantify and compare the prevalence of adverse~     events (AEs) in patients with stage III melanoma before and after initiation of interferon~     (IFN) therapy in a real-world setting. A secondary objective is to quantify annual costs and~     resource utilization before and after IFN initiation among patients with stage III melanoma~     in a real-world setting.~   "
58985|NCT02794779|"~     Introduction: postpartum hemorrage is a leading cause of death after cesarean sections in~     Brazil. Oxytocin is the main drug for both prophylaxis and threatment of postpartum hemorrage~     because uterine atony is the most prevalent cause. Both excessive and too low oxytocin doses~     threaten the life of women.~      Objective: to determine the minimum effective dose of oxytocin for cesareans during labor.~      Method: adaptative clinical trial using a modified up and down method of two sequential~     groups: rule of three and continuous infusion. Allocation in rule of three or continuous~     infusion will be random and masked for patients and anesthesiologists. The minimum effective~     dose will be the effective dose for 90% of success (ED90 for preventing uterine atony).~   "
58986|NCT02794766|"~     Halitosis associated with tongue coating results from the production of volatile sulfur~     compounds by bacterial action. The use of prebiotics and probiotics might be useful in~     treating such condition. The aim of this study was to evaluate the effect of the prebiotic~     inulin combined with the probiotic Streptococcus salivarius (SS) on halitosis by coating.~   "
58987|NCT02794753|"~     The principal aim of this study is to establish the impact of Cognitive Training in patients~     with primary Hair-pulling Disorder. Half of the participants will be training with the true~     training intervention and the other half with the active control intervention.~      Study findings will also provide information on whether an internet based CT intervention,~     done at patients' homes, is feasible as a mode of treatment for HPD patients in SA.~   "
58988|NCT02794740|"~     Primary Objectives:~      To evaluate the safety and tolerability of escalating single and multiple doses of X0002~     administered as a topical application.~      Secondary Objectives:~      To characterize the single and and multiple pharmacokinetics of escalating doses of X0002 and~     its active metabolite ibuprofen as a topical application.~   "
58989|NCT02794727|"~     Decreased physical activity is not only associated with multiple chronic medical conditions,~     including obesity, but also with depressed mood, and other negative emotions. As many~     employed adults spend a great deal of time at work where we are predominantly sedentary,~     strategies to increase physical activity at work are being pursued to help improve the~     physical and mental health of Americans. This 17 week randomized controlled trial will~     investigate changes of occupational physical activity in three groups: those provided with a~     FitBit® but not able to monitor their activity level, and those provided with activity goals~     and individual physical activity challenges, and those who do not use a FitBit®.~   "
58990|NCT02794714|"~     This study compares surgeon's satisfaction of operating conditions and patient's satisfaction~     following laparoscopic gynecological surgeries in two groups of patients, half of whom will~     receive deep neuromuscular blockade and the other half, moderate neuromuscular blockade.~   "
58991|NCT02794701|"~     Objectives: This study aims to explore the risk profiles among people with silicosis in Hong~     Kong underpinned by the Pittsburgh Mind-Body Center model.~      Design and subjects: This study will adopt a cross-sectional study design with sampling~     stratified by participants' degree of incapability. 320 Chinese people diagnosed with~     silicosis and registered with the Pneumoconiosis Compensation Fund Board will be recruited.~      Data collection: A demographic data sheet and the St. George's Respiratory Questionnaire will~     be used to collect the socio-demographic and clinical characteristics of the participants.~     The behavioral factors (smoking, drinking, physical activity level, consumption of vegetable~     and fruits and plasma vitamin C level) as well as the psychological risk factors (anxiety and~     depressive symptoms, and social support) will be examined by validated questionnaires.~     Biological and physiological parameters, including insulin resistance, C-reactive protein,~     hemoglobin, fasting blood glucose and lipid profiles, will be ascertained by fasting blood~     sample.~      Data analysis and expected outcomes: The findings of this study will create the database~     profile of the physical, psychosocial and disease specific aspects among people with~     silicosis in Hong Kong, subsequently forming the empirical basis of an intervention to tackle~     the identified modifiable risks among them.~   "
58992|NCT02794688|"~     RATIONALE and PURPOSE: For non-lactational mastitis patients pathologically diagnosis of~     idiopathic granulomatous mastitis (IGM) or periductal mastitis (PD), the investigators~     hypothesized that ductal lavage is able to relieve the symptoms and achieve complete~     response, with shorter recovery time than oral intake of antibiotics or corticosteroids~     treatments. This single arm, observational, case series, pilot study is going to evaluate the~     effectiveness of ductal lavage in patients with non-lactational IGM or PD.~   "
58993|NCT02794675|"~     The purpose of this study is to explore the use of a treatment called interstitial~     brachytherapy for patients who have a high risk resectable (able to be treated with surgery)~     recurrent head and neck cancer.~      Brachytherapy is a form of radiation therapy that uses radioactive seeds and implants them~     into a specific place on your body. This study is using Cesium-131 permanent interstitial~     brachytherapy.~      Cesium-131 is FDA approve for brachytherapy use, however, there are currently no research~     studies to show how effective it is for head and neck cancer. The goal of this study is~     determine the effect that the placement of Cesium-131 brachytherapy seeds has on overall~     survival as well as to assess possible side effects.~   "
58994|NCT02794662|"~     The purpose of this study is to determine if, in preterm infants < 37 weeks' gestation at~     birth receiving oxygen without ventilatory/CPAP support, oxygen environment (OE) compared~     with nasal cannula oxygen (NC), will decrease the number of episodes with oxygen saturations~     less than 85% of ≥10 seconds in a 48 hour cross over period on either intervention.~      This is a randomized cross-over pilot study with a 1:1 parallel allocation of infants to~     oxygen environment or nasal cannula oxygen using stratified permuted block design. Following~     a 24 hour period on the first intervention, infants will cross over to a 24 hour period on~     the second (alternative) intervention before crossing back to the first intervention for a~     further 24 hours and then back again to the second (alternative) intervention for a further~     24 hours.~   "
58995|NCT02794649|"~     To characterize the microbiome in 4 groups of subjects (primary hyperoxaluria type I (PH1),~     idiopathic CaOx stone, enteric hyperoxaluria (EH) and healthy participants) by comparing the~     number of species and diversity of the microbial populations and pathway for oxalate~     metabolism by paralleling the gene expression of enzymes involved in oxalate degradation by~     gut bacteria.~   "
59043|NCT02794025|"~     The purpose of this study was to investigate the effect of esmolol on hemodynamic~     parameters,tissue perfusion and the clinical prognosis of patients with severe sepsis~   "
58997|NCT02794623|"~     Tinnitus is the perception of sound in the absence of an external sound. Prevalence in the~     general population is 10 to 15%, with tinnitus severely impacting quality of life in 1-2~     percent of the population. Tinnitus therapy is based on counselling, cognitive and~     behavioural therapies in combination with sound therapies which mostly rely on masking.~      For cochlear implant candidates, the ability to use hearing aids and maskers is limited by~     the degree of their hearing loss. Reports of tinnitus prevalence in this group range from 67~     to 100% with a mean of 80%.~      In cochlear implant (CI) recipients, tinnitus suppression primarily occurs during active use~     of the cochlear implant system. In some CI recipients residual inhibition of tinnitus occurs~     when the implant is switched off. While the benefits of CI implantation on tinnitus are well~     documented, there is a group of recipients where tinnitus remains a concern in the implanted~     ear post-operatively.~      The primary aim of this study is to investigate the benefits of using tinnitus masking via a~     CI sound processor that optimises tinnitus suppression with minimal annoyance to the user.~     Furthermore a questionnaire will be employed to capture the prevalence, degree and nature of~     tinnitus in recipients.~   "
58998|NCT02794610|"~     Investigators aim to evaluate the ocular penetration of topical tacrolimus 0.03% eye drops.~      Topical tacrolimus 0.03% will be instilled into the eyes of patients 15 minutes before~     cataract surgery. Aqueous samples will be collected at the time of cataract surgery and will~     be subjected to detection of presence and level of tacrolimus.~   "
58999|NCT02794597|"~     Recent research suggests that women with substance use disorders may be at a higher risk of~     unintended pregnancy. There is a paucity of interventions specifically focused on this~     population. Through using mixed methods, this study proposes to develop a brief peer-led~     intervention (based on the Health Belief Model) to prevent unintended pregnancies among women~     entering opioid medication-assisted treatment; to assess acceptability, feasibility and the~     initial efficacy of the behavioral intervention; and to conduct exploratory analyses to~     identify the HBM constructs that are most influential on use of long-acting reversible~     contraception methods. Future research would include testing the intervention in a larger~     scale trial and with other populations.~   "
59000|NCT02794584|"~     Ventricular septal defect (VSD) is one of the most common pediatric congenital malformations.~     In recent years, in view of the rapid rise of transthoracic minimally invasive hybrid closure~     for pediatric VSD in the clinical practice, precision assessment of perioperative its~     effectiveness and safety has already become an important issue that must be solved. On the~     basis of echocardiography, integrating with characteristics associated critical care, the~     investigators focus on precision assessment of perioperative effectiveness and safety of~     transthoracic hybrid closure for pediatric VSD, compared with conventional surgical~     sternotomy repair with cardiopulmonary bypass (CPB).~   "
59001|NCT02794571|"~     This first-in-human open-label, multicenter, dose-escalation study is designed to evaluate~     the safety, tolerability, and PK of MTIG7192A alone or in combination with atezolizumab in~     participants with locally advanced, recurrent, or metastatic incurable tumors for whom~     standard therapy does not exist, has proven to be ineffective or intolerable, or is~     considered inappropriate, or for whom a clinical trial of an investigational agent is a~     recognized standard of care.~   "
59002|NCT02794558|"~     Non-randomized, Single Arm Clinical study to Evaluate the Safety and Effectiveness of MR~     Guided Focused Ultrasound Surgery in the Treatment of Early Breast Carcinomas~   "
59003|NCT02794545|"~     Although combination antiretroviral therapy (cART) can significantly reduce morbidity and~     mortality, it still fails to eradicate HIV. Given the difficulty for eradication of HIV,~     functional cure is more likely to achieve the goal. In recent breakthrough scientific~     reports, there already existed several examples of HIV-infected cases achieving the status of~     functional cure only through early administration of cART in newborns or early infected~     cases. From Taiwan centers for disease control (CDC) reports and our clinical experiences,~     more and more young men got HIV infection and the most important finding is the investigators~     can find some of them are newly infected, let's say, within six months.~   "
59004|NCT02794532|"~     Pre-oxygenation with high-flow nasal cannula oxygen has been evaluated in a limited number of~     studies and seems to be better than traditional preoxygenation with a tight fitting mask.~     Oxygenation with high-flow nasal cannula in apnea demonstrates that this could be done safely~     for up to 25 mins with preserved saturation. Based on this, the investigators want to~     evaluate whether this novel concept of preoxygenation can prolong the time to desaturation in~     emergency anesthesia while securing a possibly difficult airway. This may reduce the number~     of hypoxic events during intubation. This novel concept has already been tested in clinical~     practice in certain cases but not during rapid sequence induction for acute surgery.~      Objectives and Purpose The general purpose of this project is to compare a new preoxygenation~     technique based on humidified oxygen in a high-flow nasal cannula with traditional~     preoxygenation with a tight fitting mask during rapid sequence induction intubation with~     focus on gas exchange.~   "
59005|NCT02794519|"~     Sirukumab is a fully human anti interleukin (IL)-6 immunoglobulin G1-kappa monoclonal~     antibody (MAb) which is in development for the treatment of rheumatoid arthritis (RA). The~     continuing unmet need in subjects with asthma refractory to corticosteroid therapy and~     increased understanding of asthma pathogenesis have stimulated the development of targeted~     biologics based on predictive biomarkers. The majority of approaches to date have targeted T~     Helper 2 (Th2) cytokines or their downstream effects. Targeting IL-6 in severe asthma~     represents an unprecedented approach that has potential to address non-Th2 drivers of severe~     asthma. This multicenter, randomized, double-blind (sponsor-unblind), placebo-controlled,~     parallel group study will investigate the efficacy of sirukumab compared to placebo in~     subjects having uncontrolled severe asthma despite use of high dose inhaled corticosteroid~     (ICS) in combination with long-acting Beta-agonist (LABA). The study will employ a variable~     treatment period for individual subjects. Dosing will continue every 4 weeks until week 44~     (inclusive), or until 24 weeks after the final subject has been randomized, whichever the~     sooner. Upon receiving the final dose of study medicine or placebo, subjects will enter a 16~     week Follow Up period. Overall, the duration of participation for subjects who complete the~     full 44-week treatment period and Follow Up period may be up to 64 weeks. Approximately 175~     subjects will be randomized such that 140 evaluable subjects complete the study.~   "
59006|NCT02794506|"~     Background:~      Propolis is a natural resin made by bees from various plant sources. Propolis exerts~     antimicrobial, anti-inflammatory, immunomodulatory, antioxidant, and antidiabetic properties.~     The purpose of this study was to assess the adjunctive benefit of propolis supplementation in~     individuals with both chronic periodontitis and type 2 diabetes mellitus (T2DM) receiving~     scaling and root planing (SRP).~      Methods:~      A 6-month randomized blinded clinical trial comparing SRP with placebo (placebo+SRP group,~     n=26) or combined with a 6- month regimen of 400 mg oral propolis once daily (propolis+SRP~     group, n=26) was performed in patients with long-standing T2DM and chronic periodontitis.~     Treatment outcomes included hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), serum~     N€-(carboxymethyl) lysine (CML) and changes in periodontal parameters.~   "
59007|NCT02794493|"~     RATIONALE: Hand foot syndrome may be treated or reduced by soaking Traditional Chinese~     Medicine Formula LC09 in patients receiving capecitabine for colorectal and/or breast cancer.~      PURPOSE: This randomized phase III trial is studying soaking Traditional Chinese Medicine~     Formula LC09 to see how well they work compared to placebos in preventing hand-foot syndrome~     in patients who are receiving capecitabine for colorectal or breast cancer.~   "
59008|NCT02794480|"~     The study is conducted to evaluate the potentially improved patient handling of the ELLIPTA~     Dry Powder Inhaler (DPI). Therefore, the study aims to evaluate errors encountered by subject~     with asthma during handling ELLIPTA DPI relative to two metered dose inhalers (MDI), a GSK~     MDI and the AstraZeneca (AZ) MDI. It is a randomised, multi-centre, open-label, cross-over~     study comparing placebo ELLIPTA DPI with placebo MDI (GSK and AZ) to assess correct inhaler~     use. No active drug will be used in this study in order to prevent any drug-related effects.~     Approximately, 152 subjects will be randomized to receive ELLIPTA DPI inhaler and 152 will be~     randomized to receive one of the MDI inhalers, for use during the first period (P)~     (approximately 28 days). At Visit 2 (Day 28) all subjects previous receiving the ELLIPTA DPI~     will be randomized to receive one of the MDI inhalers and all subjects who received a MDI in~     the previous period will receive the ELLIPTA DPI for use during second period (approximately~     28 days). Subjects will continue taking their asthma maintenance treatment and limited rescue~     albuterol MDI during the entire 56-day study period.~      ELLIPTA is a registered trademark of the GSK group of companies.~   "
59009|NCT02794467|"~     The primary objective of the study is to assess the efficacy, safety, and tolerability of~     epelsiban compared with placebo in treatment of women with adenomyosis.~      This is a 12-week, randomized, double-blind, placebo-controlled, parallel group study with an~     interim futility analysis. Subjects will be randomized 1:1:1 to receive 75 milligrams (mg) of~     epelsiban three times daily (TID), 200 mg of epelsiban TID, or placebo TID. The study will be~     composed of three periods: screening, treatment, and follow-up and the total time a subject~     will be in the study will be approximately 6 months.~   "
59010|NCT02794454|"~     Sexual function is a part of a normal healthy life and considered to be essential for mental,~     physical and marital well-being. Any derangement in normal function though is a distressing~     situation for the individual, is often not reported due to embarrassment or due to social~     stigma. Sexual disorders in men are categorized according to the stage of sexual response~     affected in terms of disorders of erectile function, ejaculatory function or libido, albeit~     there is considerable potential for overlap amongst the disorders. The use of current~     intervention has many side-effects and has been prohibited in cardiovascular condition and~     also to be taken with caution with other medical condition.~      This has led to the development of multiple alternate therapies which are helpful for a~     limited number of cases but the major concern for all these therapies is their late onset of~     action and not having a sustained effect.~   "
59011|NCT02794441|"~     Migraine recurrence is common amongst pediatric patients being discharged from the emergency~     department after treatment for migraine. Despite the commonality of migraine recurrence~     within the week following discharge, no known effective therapies are available in the~     pediatric population, though dexamethasone has been established as efficacious in the adult~     migraine population. The proposed study will randomly assign children and adolescents~     visiting the emergency department (ED) for migraine to receive either one dose of oral~     dexamethasone or oral placebo. Twenty patients will be recruited to this randomized,~     double-blind, pilot trial over a 6 month period, and the aim of the study will be to~     determine the feasibility and acceptability of the protocol.~   "
59012|NCT02794428|"~     A clinical study of the efficacy of oral alpha-difluoromethylornithine (eflornithine or DFMO)~     in male and female subjects ages 30-60 with gastric premalignant lesions in two high risk~     regions of Latin America.~   "
59013|NCT02794415|"~     The primary aim of this research is to evaluate a community-based exercise (CBE) intervention~     for adults living with HIV within the community with the goal of reducing disability and~     enhancing health (cardiopulmonary, strength, weight and body composition, and neurocognitive~     outcomes) and contextual factor outcomes (social support, stigma, mastery, coping) for adults~     living with HIV.~   "
59014|NCT02794402|"~     Combat-JUDO (Combating Juvenile Diabetes and Obesity through normalization of beta-cell~     function) is part of a collaborative project funded by the Seventh Framework Programme of the~     European Commission aiming to develop innovative therapeutic strategies by increasing~     pharmacology-based alternatives targeting insulin hypersecretion for the treatment of young~     obese individuals.~      The prevalence of childhood obesity is ranging between 5-25% in Europe. The reason behind~     these alarming figures is mostly a changing environment with a more sedative lifestyle and~     supply of excess food. However, specific gene mutations have also been linked to obesity and~     new genes are continuously being discovered. There are very few effective means of~     intervention in children with obesity available today. Obesity is closely associated with a~     number of related metabolic diseases and some children with obesity develop the metabolic~     syndrome at an early stage in life. Individuals with obesity have an increased risk of~     developing type 2 diabetes mellitus (T2DM) and with the current increase in childhood~     obesity, some children will develop T2DM already in their adolescent years with huge impact~     on their long-term health and life expectancy.~      Lifestyle modification interventions, including behavioural treatment, diet modification and~     physical activity, are cornerstones of primary and secondary prevention/treatment of~     pediatric obesity today. Exenatide is a GLP-1 (glucagon-like peptide-1) receptor agonist~     approved for use in adults with T2DM to improve glycemic control. A pilot study with~     exenatide treatment in non-diabetic children and adolescents with severe obesity showed a~     reduced BMI of approximately 5% and improved markers of insulin resistance and β-cell~     function were observed.~      The Combat-JUDO study is a parallel, double-blind, randomized study comparing lifestyle~     intervention + exenatide 2 mg vs lifestyle and intervention + placebo in adolescents with~     obesity. The lifestyle intervention includes regular nutritional and psychological support at~     4 occasions during the study as well as physical activity on a weekly basis.~     Exenatide/placebo is given as a subcutaneous injection once weekly for 24 weeks. The primary~     objective of the study is to compare the change in BMI-SDS (according to WHO) from baseline~     to the 6 months visit between the two treatment arms.~      The study includes males and females of age 10-18 years and 5 months with BMI SDS >2.0 or~     age-adapted BMI >30 kg/m2.~   "
59015|NCT02794389|"~     The investigators will examine whether compulsivity in those who score above-average (but~     below clinical cut-off) on an eating disorder questionnaire can be altered by 9 days of~     N-acetyl cysteine (NAC). N-acetyl cysteine has been shown to be of some benefit in~     individuals with other compulsive disorders, such as trichotillomania and addiction, so this~     research investigates whether a short period of time taking N-acetyl cysteine changes~     compulsivity, measured using cognitive tasks and questionnaires.~   "
59016|NCT02794376|"~     This study investigates the effectiveness of a 6 week mindfulness intervention in reducing~     symptoms of Irritable Bowel Syndrome (IBS). All Participants will receive treatment.~     Participants will be randomly allocated to an immediate treatment group and a waiting list~     control group.~   "
59017|NCT02794363|"~     15 patients with biopsy proven active vulvar lichen sclerosus will be recruited by a clinic~     specializing in vulvar disorders. This study consists of a 2 week screening period and a~     12-week treatment period. Participants will receive two separate treatments of autologous~     platelet rich plasma separated by 6 weeks. A repeat biopsy will be performed 6 weeks after~     the second autologous platelet rich plasma injection~   "
59018|NCT02794350|"~     The cognitive profile of older adults with a severe to profound hearing impairment is~     determined by means of the Repeatable Battery for the Assessment of Neuropsychological~     Status, adjusted for Hearing impaired subjects (RBANS-H) before and after cochlear~     implantation. In this prospective, longitudinal study the participants are tested~     preoperatively, at six months and twelve months postoperatively and from then on yearly up to~     10 years after implantation. In addition to the RBANS-H an audiological examination and an~     semistructured interview is conducted concerning the cochlear implant use and the~     self-reliance of the patient and subjective questionnaires are filled out by the subjects to~     assess quality of life and hearing benefit.~   "
59019|NCT02794337|"~     Vast majority of patients with hepatocellular carcinoma (HCC) present with unresectable~     disease. In the last decade results of randomized trials and a subsequent metaanalyses~     established transarterial chemoembolization (TACE) or systemic chemotherapy (sorafenib) as~     standard of care. However, TACE alone is not a curative approach. The two year survival~     following TACE ranges from 31-63% with almost 100% patients developing disease progression~     after treatment. There is need to investigate additional therapeutic options that would~     consolidate the initial response to TACE. A recent metaanalyses concluded that addition of~     high dose radiation to TACE results in 10-35% improvement in two year overall survival.~     However as results of metaanalyses were based on studies with small sample size, unclear~     randomization procedure and heterogenous dose of radiation, the need for conducting a high~     quality randomized study was highlighted The present study is designed to investigate the~     role of high dose conformal radiation as consolidation therapy after TACE in patients with~     nonmetastatic unresectable HCC.~   "
59020|NCT02794324|"~     Radiotherapy (RT) has a major curative role in women with early breast cancer, and is~     recommended routinely after lumpectomy and selectively after mastectomy. It has contributed~     to a halving of breast cancer mortality in the UK over the last 2 decades despite ever-rising~     cancer incidence. RT in women with left-sided tumours often exposes the underlying heart to a~     damaging dose. The heart is very sensitive to RT, and there were 1-2 deaths from heart~     disease for every 100 breast cancer patients treated during the 1960s-70s. The situation has~     improved in recent years, but standard RT techniques still deliver significant radiation~     doses to heart tissue.~      Two potentially simple techniques reduce heart dose. In one, women are taught to breathe in~     deeply and to hold their breath for about 20 seconds while RT is given. The downward movement~     of the diaphragm pulls the heart away from the RT beam. In the other technique, women lie on~     their fronts, instead of on their backs as they normally do for breast RT. In this position,~     the breast falls away from the rib cage and reduces exposure of the heart. Neither technique~     is routinely available to women receiving breast RT in the UK for reasons that this research~     aims to address. The investigators need to: 1) confirm that patient position can be~     reproduced with millimetre precision every day using these techniques, 2) minimise costs of~     equipment, time and personnel required to support such techniques, 3) select the most~     appropriate technique for different patients and 4) train staff in centres across the UK to~     deliver techniques safely and effectively. By addressing all of these issues, the study aims~     ultimately to make heart-sparing RT available to all UK women that might benefit from~     treatment, thereby significantly reducing the burden of heart disease in breast cancer~     survivors.~   "
59021|NCT02794311|"~     The purpose of this study is to specify the psychological, cognitive, neuro-functional and~     genetic profile associated with binge drinker behaviors among young adults. Results will help~     identifying more precisely vulnerability factors associated with this pattern of alcohol~     consumption and guiding prevention efforts.~   "
59022|NCT02794298|"~     The aim of this study is to investigate whether anodal tDCS over the left M1 leads to a~     decrease of GABA concentration and alterations of functional brain connectivity in younger~     people, compared to sham tDCS.~   "
59023|NCT02794285|"~     The purpose of this study is to characterise long-term safety and tolerability of intravenous~     anifrolumab.~   "
59024|NCT02794272|"~     The aim of this study is to investigate whether anodal tDCS over the left M1 leads to a~     decrease of GABA concentration and alterations of functional brain connectivity in older~     people, compared to sham tDCS.~   "
59025|NCT02794259|"~     The aim of this study is to investigate whether anodal tDCS over the left M1 leads to a~     decrease of GABA concentration and alterations of functional brain connectivity in older~     people, compared to sham tDCS.~   "
59026|NCT02794246|"~     This will be a single-arm, open-label study. Patients will be enrolled during induction~     therapy for multiple myeloma, prior to standard-of-care consolidation with autologous stem~     cell transplantation (ASCT). T cells will be harvested for T cell manufacturing prior to~     ASCT, and CART-19 will be infused at day ~60 post-ASCT, 3 days after lymphodepleting~     chemotherapy. The primary endpoint is progression-free survival (PFS) after ASCT. As detailed~     below, the study is powered to detect an increase in two-year PFS to ~75% from a baseline~     expectation of 55% based on historical data. Secondary endpoints will evaluate CART-19~     persistence and function, minimal residual disease, immune correlative endpoints, and~     associations of progression-free survival (PFS) with CART-19 persistence and clinical and~     biologic characteristics of multiple myeloma.~   "
59027|NCT02794233|"~     The study will look into the changes of Deep Brain Stimulation (DBS) measured impedances in~     patients of Parkinson disease (PD) as a function of their functional state (lying, sitting~     and walking) and dopaminergic medication intake (levodopa or dopamine agonists).~      The goal is to use DBS measured impedance as a surrogate of the functional and medication~     states of PD patients.~   "
59028|NCT02794220|"~     The purpose of this study is to assess the amount of nicotine that is absorbed into the blood~     stream following the use of a new Electronic Cigarette device called the CN electronic~     cigarette. The amount of nicotine delivered via the CN electronic cigarette will be compared~     to the amount of nicotine delivered from smoking a regular cigarette and from using the~     Nicorette® Inhalator.~      Electronic cigarettes aim to mimic the experience of cigarette smoking, by delivering~     nicotine rapidly. Unlike cigarettes however, they do not contain all of the many harmful~     combustion products contained in tobacco smoke.~      Electronic cigarettes are readily available in many markets, and may contain significant~     quantities of nicotine. However, they are not regulated as medicines, and their manufacturers~     can make no medicinal claims about them.~      Such products are unregulated, having not been subjected to regulatory review by either the~     Medicines and Healthcare Products Regulatory Agency (MHRA) or any Notified Body.~      It is the intention of CN Creative (makers of the CN electronic cigarette) to submit an~     application to the MHRA for the CN Electronic Cigarette, in order to make a high quality,~     regulated product available. Males aged 18-65, who smoke and who have no intention of~     stopping smoking during the trial are eligible to take part in this study. The study consist~     of a screening visit, a treatment period with 5 overnight stays with nicotine treatment on~     days 1, 2, 3 and 4 with a post study visit on day 5.~   "
59029|NCT02794207|"~     The primary objectives of this study are to identify what outcomes related to the management~     of neutropenia are most important to children with AML and their caregivers. Patients who~     have completed treatment for AML and their caregivers will be interviewed in order to better~     understand the impact of neutropenia management on children with AML and their families. The~     primary outcome of these interviews is to identify patient-centered outcomes related to~     neutropenia management to include in a subsequent comparative-effectiveness analysis.~     Investigators will use these data to develop a structured survey for administration to~     prospectively identified patients in subsequent studies.~   "
59030|NCT02794194|"~     After an initial ankle sprain, Chronic Ankle Instability is one of the most common residual~     symptoms which include pain, swelling, recurrent sprain, episodes of ankle joint giving~     away or decreased function. Recently, Whole Body Vibration (WBV) training has been~     introduced as a preventive and rehabilitative tool. It can be hypothesized that WBV on~     unstable surfaces might enhance neuromuscular control. Therefore, the aim of this study was~     to investigate the effects of a 6-week WBV training on an unstable surface on body~     composition, balance, strength and reflex and muscle activity of ankle muscles in~     recreational athletes with CAI.~   "
59031|NCT02794181|"~     Background:~      Zika virus is mostly passed on by the bite of an infected mosquito. It usually causes mild~     illness. But in pregnant women it can cause serious birth defects to the baby. The virus can~     also spread by blood transfusion and sexual intercourse. This is why the U.S. Food & Drug~     Administration (FDA) recommended that people should not give blood if possibly exposed to~     Zika virus. Dengue virus and chikungunya virus are passed by the same mosquitoes as Zika~     virus. These can cause severe reactions if passed through transfused blood.~      Donated blood is usually not tested for these three viruses. Researchers want to count the~     infections in people who have been exposed because of travel or sexual exposure. They want to~     learn the risk these viruses might pose to the U.S. blood supply. They also want to study the~     natural history of these viruses by following infected people over time.~      Objective:~      To study the risk of Zika, dengue, and chikungunya viruses to the U.S. blood supply.~      Eligibility:~      Adults age 18 or older who were turned down for donating blood because of possible exposure~     to certain viruses.~      Design:~      Participants will have blood and urine tests. They will answer questions about their travel.~      They will be called in about a week with virus test results.~      Participants with negative results do not have any more study visits.~      Participants with positive results will be asked to stay in the study for 6 months. They will~     have weekly clinic visits and tests until results are negative for 2 straight weeks. Once~     test results are negative, they will have monthly visits. Visits will include physical exams,~     blood and urine samples, and optional semen samples from men.~      Most people will have 3-4 weekly visits and 5 monthly visits.~   "
59032|NCT02794168|"~     This study evaluates the efficacy of an infusion of Ronopterin (VAS203) on clinical outcome~     in patients with moderate and severe traumatic brain injury. Half of the participants will~     receive Ronopterin (VAS203), while the other half will receive placebo.~   "
59033|NCT02794155|"~     This will be a Phase 2b, multicenter, randomized, double blind, titration clinical study,~     evaluating the efficacy and safety in the HDV Insulin Lispro Group versus Insulin Lispro~     Group in patients with type 1 diabetes over a 26 week treatment period. The patients will be~     randomized using a centrally allocated randomization scheme to 1 of the 2 treatment arms in~     an overall 2:1 scheme (HDV Insulin Lispro: Insulin Lispro). Both arms will receive the~     randomized treatment in combination with glargine or detemir. Goal to demonstrate that the~     efficacy of HDV insulin lispro administered in combination with a basal insulin (HDV Insulin~     Lispro group) is non-inferior to insulin lispro in combination with a basal insulin (Insulin~     Lispro group), in effects on glycated hemoglobin (HbA1c) in patients with type 1 diabetes. If~     non-inferiority is demonstrated, confirm that HDV insulin lispro in combination with a basal~     insulin (HDV Insulin Lispro group) is superior to insulin lispro in combination with a basal~     insulin (Insulin Lispro group), in effects on HbA1c in patients with type 1 diabetes (≥ 0.4%~     decrease in HbA1c).~   "
59044|NCT02794012|"~     The purpose of this study is to evaluate the association of Rheumatoid Arthritis (RA)-related~     antibodies and periodontal inflammation in subjects at-risk for Rheumatoid Arthritis.~     Subjects will undergo periodontal and joint examinations, as well as collection of body~     fluids to measure Rheumatoid Arthritis-related antibodies.~   "
59298|NCT02790697|"~     This study aims at validating the accuracy of the new indirect calorimeter (Q-NRG, COSMED,~     Italy), developed for the ICALIC multicenter study. The validation of accuracy will only be~     conducted in Geneva center.~      The measurements made with the new calorimeter will be compared to the measurements by the~     mixing chamber method using a mass spectrometer (MAX300-LG, Extrel, USA) for gas composition~     analysis.~   "
59034|NCT02794142|"~     In hemodialysis patient (HD) a reduction of the skeletal muscle mass and strength has~     previously been reported. This muscle impairment constitutes an independent prognosis factor~     in HD patients. Oxidative stress and inflammation have been linked to the muscle impairment.~     The mitochondria is a classical producer and target of reactive oxygen species (ROS), and may~     thus constitute a central actor of the skeletal muscle impairment in HD patients. Therefore,~     the aim of the present study is to investigate the role of the muscle mitochondrial density~     on the muscle impairment in HD patients, in comparing the muscle mitochondrial density and~     oxidative stress in HD patients vs. healthy matched controls.~      In order to assess the effect of the oxidative stress and inflammation on the muscle~     impairment in HD patients, muscle function assessements will be performed after renal~     transplantation (which lowers the oxidative stress and inflammation levels) in the HD patient~     group.~      No therapeutic intervention will be tested in the present study.~   "
59035|NCT02794129|"~     Bipolar disorder is a mental disease characterized by mood dysregulation and arises from~     manic, depressive or mixed episodes. The observations of the patient's speech and language~     behaviour due to flight of ideas or loss of goal probably result from an underlying~     disturbance in semantic networks dealing with semantic associations. The aim of our study~     will be to have a better comprehension of thought disorders in bipolar disorder by cognitive~     exploration of semantic processing.~   "
59036|NCT02794116|"~     Aim: To evaluate the clinical survival of fluoride sealants applied in first permanent molars~     affected by Molar-Incisor Hypomineralization (MIH).~      Material and Methods: For this case control study, it was selected 41 first permanent molars~     of the 21 children aged 6-8 years. MIH was classified by one calibrated examiner (kappa 0.80)~     according severity of the MIH lesion (EAPD, 2003). Inclusion criteria were FPM with MIH or~     sound (without MIH), fully erupted, and with sealant treatment indication.~      The FPMs were assigned into two groups: G1 - Control group and G2 - MIH group. Both group~     teeth were treated with sealant application (Fluroshield, NY, USA). Clinical follow-up was~     performed at baseline, 1, 6, 12 and 18 months for anatomic form, marginal adaptation,~     retention and presence of caries, according to the United States Public Health Service~     USPHS-Modified by a blinded examiner (kappa 0.80). The Acturial Method was used to evaluate~     the survival of sealants. Statistical analysis compared the ratings of each criterion between~     materials using the Fisher's exact test at a level of significance of 5% (p<0.05).~   "
59037|NCT02794103|"~     Procedural pain is the most intense and often undertreated pain associated with burn~     injuries. The use of analgesics does not always provide optimal relief and is accompanied by~     several side effects. Indeed, children with burn injuries still experience severe pain~     intensity during procedures despite the fact that doses of analgesics used with this~     population has almost doubled in the last twenty years. Current guidelines on pediatric~     procedural pain management recommend the combination of non-pharmacological and~     pharmacological interventions to enhance pain management and decrease the numerous side~     effects of analgesics. Distraction has been identified among the most effective~     non-pharmacological interventions for pain as it diverts the child's attention to an~     attractive element, hindering the perception of the painful stimuli. Virtual reality is a~     method of active distraction that offers the child a multi-sensory immersive interaction that~     found many applications for pain management in adult patients. However, very few studies have~     tested the efficacy of distraction by virtual reality on procedural pain and anxiety in~     children with burn injuries.~      The aim of this study is to assess the feasibility and preliminary efficacy of a virtual~     reality prototype developed specifically for the hydrotherapy room of children under seven~     years old for the relief of procedural pain and anxiety in children with burn injuries.~     HYPOTHESES: a) VR distraction is a feasible non-pharmacological intervention for pain~     management during hydrotherapy, b) VR distraction combined with analgesics is more~     efficacious than standard treatment (analgesics alone) on procedural pain and anxiety~     (hydrotherapy) of young children with burn injuries.~   "
59038|NCT02794090|"~     This study evaluates if usual physical care visits to an outpatient pediatric clinic can be~     replaced with more frequent and shorter Telephone coaching Contacts during 18 months.~   "
59039|NCT02794077|"~     There is no standard third-line systemic treatment for inoperable locoregionally advanced~     recurrent or metastatic nasopharyngeal carcinoma (NPC). We investigated the efficacy and~     safety of metronomic oral cyclophosphamide as third-line treatment or beyond.~   "
59040|NCT02794064|"~     Breast conservation surgery (BCS) is performed on patients with breast cancer with the intent~     to resect and completely remove the tumour while conserving as much of the surrounding normal~     tissue as possible. Currently, there is no way for surgeons to determine the adequacy of~     surgical resection in real-time during surgery; the assessment of surgical margins requires~     histological examination that is not available in real-time and is impractical in most~     clinical cases. This results in a re-excision rate of 23% among Canadian women in order to~     achieve optimal surgical margins. In addition, the presence or absence of cancer in tumor~     draining lymph nodes is recognized as a key element for breast cancer staging; however, lymph~     node dissection can be associated with overtreatment and morbidity (nerve damage and post~     surgical lymphedema) and histological analysis of nodes can be time consuming and thus delay~     subsequent procedures. In an effort to address these issues, we have designed and~     constructed, in collaboration with Sogang University, Seoul, S. Korea, a novel imaging system~     that performs three complementary imaging modalities (tri-modal): ultrasound (US),~     photoacoustic (PA) and fluorescence (FL).~      This first-in-human pilot study will recruit 10 breast cancer patients undergoing breast~     conserving surgery at Princess Margaret Hospital (Toronto, Canada). The study is designed to~     test our tri-modal (US, PA, FL) imaging technology in breast cancer patients. The overall~     goal is to obtain initial information on the technical feasibility of the tri-modal system in~     a peri-operative setting and to confirm the anticipated safety of the procedures.~     Additionally, it will provide initial data on the ability of this system to detect/localize~     primary breast cancer lesions and cancer-involved lymph nodes prior to surgery.~   "
59041|NCT02794051|"~     This study fills a notable gap in the transdiagnostic literature by evaluating whether an~     evidence-based transdiagnostic treatment for emotional disorders such as the Unified Protocol~     for Children (UP-C) is effective for treating childhood behavior problems.~   "
59042|NCT02794038|"~     This study scope is to validate the accuracy and usability of the Soberlink Cellular Device~     in comparison to a predicate device, BACtrack S80 Pro.~   "
59045|NCT02793999|"~     The purpose of this study is to improve the ability of the investigators to monitor brain~     health in newborn babies at risk of brain injuries. The researchers will be using an~     investigational system of devices to non-invasively (that, is, without penetrating the skin),~     measure the amount of oxygen going to and being used by the brain. They will be taking some~     bedside research measurements during the babies' stay at the hospital. With these~     measurements, the intention is to study the role of oxygen in brain injury and test the~     efficacy of the research device and its potential as a permanent bedside diagnostic device.~   "
59046|NCT02793986|"~     With blocks of lumbar and lumbar plexus, we can reduce the intravenous anesthetics usage. To~     offer an satisfied surgery process for patients, a proper sedation is necessary. So in this~     study, we want to investigate the influence of two different sedative drugs on outcomes of~     patients received hip replacement surgery .~   "
59047|NCT02793973|"~     A structural leg length discrepancy (SLLD) is a common clinical problem. Its prevalence has~     been estimated at 40-70%. Those who have been suffered from limping for a long time may lead~     to follow-up low back pain and lower limb musculoskeletal disorders. Although lower limb~     triple view of x-ray is considered to be the current technique for determining LLD, it is~     costly and time consuming that not every hospital can afford it, and in case of radiograph,~     the patient is exposed to radiation. Therefore, it is necessary to develop a rapid clinical~     assessment method by gathering exterior parameters to build up a Regression model for~     measuring the discrepancy and determining LLD accurately.~      While using shoe lifts to correct discrepancy is the easiest conservative intervention for~     LLD, there are still many controversies on how much height should be added clinically and~     academically. The optimal height should be added depends on feedbacks from users and gait~     performance. The best gait performance can be measured from kinematic performance of center~     mass of body during walking. Therefore, this project wants to compare treatment responses~     between two kinds of shoe lift height correction methods for LLD: given 80% discrepancy in~     shoe lift height correction through triple view of x-ray and given optimal shoe lift height~     correction through analyzing kinematic performance of center mass of body.~   "
59048|NCT02793960|"~     This is a single-center study to investigate the effects of a topical cream on patients 12~     years of age and older that have been diagnosed with epidermolysis bullosa.~   "
59049|NCT02793947|"~     The purpose of this study is to determine the efficacy and safety of a peri-incisional~     multimodal injection for post-operative pain control following operative management of femur~     fractures. Enrolled subjects will be prospectively randomized into either the peri-incisional~     injection or control cohorts. Patients will be treated with standard of care surgical~     techniques by the treating orthopaedic surgeon for the patient's specific fracture pattern.~     The patients randomized into the injection cohort will receive an intra-operative injection~     with 400 mg ropivacaine, 0.6 mg epinephrine, 5 mg and morphine into the local superficial and~     deep peri-incisional tissues while under general anesthesia. Visual analog pain scores will~     be collected every 4 hours after surgery for the first two post-operative days. Total~     narcotic consumption will also be recorded over eight hour intervals for the first two~     post-operative days. Medication related side effects will be monitored. The investigators~     hypothesize that the peri-incisional injection cohort will demonstrate an improved pain~     profile and utilize less parenteral narcotic analgesia in the early post-operative period.~   "
59050|NCT02793934|"~     The Programme is focused on adult patients of any gender and age more than 18 y.o., with the~     next conditions:~        1. Acute cerebrovascular events (ACE, ischemic stroke or intracerebral hemorrhage -~          specialty neurology)~        2. Acute myocardial infarction (AMI, specialty cardiology)~        3. Patients after total hip replacement (THR, specialty orthopaedia) The program is~          performed in the in-patient and out-patient rehabilitation departments in 13 regions of~          the Russian Federation (total 244 departments).~   "
59051|NCT02793921|"~     This randomized control trial will examine whether a well-controlled and monitored site-based~     exercise intervention, initiated before beginning aromatase inhibitor (AI) therapy, improves~     cognitive function in postmenopausal women with early-stage breast cancer and will explore~     whether neuroimaging metrics of brain health, pro-inflammatory biomarkers and symptoms~     (fatigue, sleep problems, depression, anxiety) mediate the effects of exercise on cognitive~     function. Furthermore, the study will explore whether the magnitude of the improvements in~     cognitive function are modified by estradiol levels.~   "
59052|NCT02793908|"~     The aim of the study protocol will be to compare the efficacy of subcutaneous progesterone~     (25 mg / day; Pleyris, IBSA Institut Biochimique SA) with vaginal progesterone (90 mg / day;~     Crinone, Merck Serono) administered during the luteal phase in term of pelvic pain reduction~     in patients with grade I-II endometriosis and / or endometrioma <4 cm subjected to time~     intercourses or COS/IUI cycles.~   "
59053|NCT02793895|"~     The aim of the SEARCH-AF trial is to evaluate a novel diagnostic tool for detecting~     post-operative atrial fibrillation or flutter (POAF/AFL) in cardiac surgical subjects during~     the early, sub-acute post-operative period. The population includes cardiac surgical subjects~     who have either developed or are at risk for developing new onset POAF/AFL and who are at~     risk for stroke, as determined by their CHA2DS2-VASC (congestive heart failure, hypertension,~     age ≥75 years (2 points), diabetes mellitus, previous stroke/transient ischemic attack (TIA)~     (2 points), vascular disease, age 65-74 years, sex class (female)) score. These subjects must~     not have had a history of AF/AFL before cardiac surgery.~      The intervention group will undergo 30 days of continuous cardiac rhythm monitoring with an~     adhesive, patch-based monitor (Medtronic SEEQ™ mobile cardiac telemetry system). The control~     group will receive usual care, which does not involve planned cardiac rhythm testing within~     the first 30 days after study randomization. The primary outcome is documentation of~     sustained atrial fibrillation or flutter within the first 30 days after randomization. In~     addition, subjects in both groups will undergo 14 days of continuous cardiac rhythm~     monitoring with the Medtronic SEEQ™ mobile cardiac telemetry system at 6±1 months after their~     index cardiac surgery.~   "
59054|NCT02793882|"~     1.0 Background & Introduction Positron emission tomography / computer tomography (PET/CT) is~     a nuclear medicine procedure based on the measurement of positron emission from radiolabelled~     tracers. This technology allows biologic processes to be visualized and measured on whole~     body images. Common radiotracers in use today in the USA and Europe are radiolabelled choline~     derivatives such as the analogs 18F-fluoromethylcholine (FMCh) and 18F-fluoroethylcholine~     (FECh), or more broadly FCH. Both of these fluorinated choline analogs have been extensively~     studied and display seemingly identical biological, radiopharmaceutical and radiochemical~     properties. Both have been extensively studied in human prostate cancer, with FMCh having~     slightly more published data than FECh. Imaging with radiolabelled choline derivatives is~     used to determine sites of abnormal choline metabolism and can be used to characterize~     prostate cancer, for which there is extensive data in the literature. PET/CT with~     radiolabelled choline derivatives is considered standard of care by some experts where~     available, however at the JGH, anatomic imaging with CT and MRI, and bone scan are the~     current diagnostic imaging modalities in use for this patient population. Prostate cancer~     cells have increased choline uptake compared to normal tissues, forming the molecular basis~     for this technique. The Gleason score, a histopathologic measure of tumor aggressiveness, is~     one of the most important prognostic factors in the disease. The objective of this study is~     to evaluate if the degree of uptake measured by maximum standard uptake value (SUVmax) on FCH~     PET/CT in prostate cancer correlates with Gleason score at initial biopsy.~      2.0 Study Objectives The objective of this study is to evaluate if the patient-wide SUVmax on~     18F-FCH PET/CT in locoregional and metastatic prostate cancer correlates with histopathologic~     Gleason score at initial biopsy. It is hypothesized that SUVmax will correlate positively~     with Gleason score. This is of interest because non-invasive risk stratification may be~     possible in the future.~      3.0 Study Design This will be a single-site JGH-only open label study in which one (1)~     18F-FCH PET/CT will be performed on study participants. A PET/CT scan takes about 3 hours.~      4.0 Safety & Ethics The radiation dose to patients from fluorinated choline derivatives~     compares favorably to the major PET tracer in widespread clinical use, 18F-fluorodeoxyglucose~     (18F-FDG). The safety of fluorinated choline derivatives is not disputed and the~     investigators expect the number of adverse events in this study to be at (or near) zero.~     There is no established toxicology for diagnostic doses of fluorinated choline derivatives.~      There are no salient ethical considerations identified. The treating physicians are free to~     order any diagnostic or therapeutic intervention on study patients, and care will not be~     modified or restricted in any way. Treating physicians are free to incorporate information~     acquired with this study or discard it if it is not relevant. Care of the patients may be~     improved with additional information provided by FCH PET/CT, but it is otherwise unchanged.~     No vulnerable populations will be included in the study.~      5.0 Confidentiality All information (medical history, physical examination, and PET/CT~     results) will be kept strictly confidential and only authorized personnel will have access.~     The reports of the PET/CT will be contained in a password protected radiology & nuclear~     medicine RIS database (RadImage) where all other diagnostic imaging reports are securely~     stored. Clinical PET/CT reports will be stored indefinitely, whereas all other study data~     will be kept locked by the PI and destroyed after 10 years.~      6.0 Population, Sample Size and Recruitment A maximum of 225 competent adult male medically~     stable prostate cancer patients with available Gleason Scores will be entered into the study.~     Patients will be recruited by urologists in the clinical setting. Initial contact and consent~     will be by the department of urology.~   "
59086|NCT02793466|"~     This clinical trial is the first clinical trial to study Durvalumab, a checkpoint inhibitor~     which stimulates the patient's own immune system to act against cancer cells in children and~     adolescents. This trial will assess the safety and tolerability of Durvalumab in children and~     adolescents and also study how Durvalumab is processed in their bodies.~   "
59055|NCT02793869|"~     Congenital cataracts (CC) are the leading cause of childhood visual disabilities and~     treatable childhood blindness worldwide1. CC patients have a wide range of presentations of~     lens opacities and are generally categorized into several groups based on the etiologies,~     anatomical positions, or shapes of lens opacities. Cataractous eyes of CC patients are also~     frequently complicated with other anterior segment abnormalities due to their close~     anatomical relationships and similar developmental origins. Lens opacities in different~     positions may be related to specific anterior segment abnormalities; for example, anterior~     polar cataracts are associated with greater corneal astigmatism (CA). However, no studies~     have systematically related the position of lens opacities to specific anterior segment~     abnormities, mainly due to the small number of CC patients, a lack of proper equipment, and a~     lack of awareness of these important relationships.~   "
59056|NCT02793856|"~     This study will evaluate the safety of PD-1 knockout engineered T cells in treating~     metastatic non-small cell lung cancer. Blood samples will also be collected for research~     purposes.~   "
59057|NCT02793843|"~     Background: Common adverse side effects related to the use of neuraxial opioids in the~     obstetric population include nausea, vomiting, and pruritus. Serotonin (5-HT3) receptor~     antagonists, in particular ondansetron, have been identified as possible antipruritic agents.~     It was reported that dexamethasone plus ondansetron is more effective than ondansetron for~     prevention of postoperative nausea and vomiting but no additional effect on treating~     pruritus.~      Objectives: The purpose of this study is to compare the effect of prophylactic ondansetron~     versus ondansetron plus dexamethasone after cesarean section on pruritus and postoperative~     nausea and vomiting (PONV).~      Methods: A prospective randomized double blind study that will be conducted between June 2016~     and June 2017. Patients will be randomly allocated into two groups. The first group will~     receive 4 mg intravenous (IV) ondansetron while the other group will receive 4 mg IV~     ondansetron plus 8 mg dexamethasone.~   "
59058|NCT02793830|"~     This study evaluates the feasibility and acceptability of using mobile applications to~     improve medication adherence. Participants in the experimental group will receive educational~     materials and daily reminders through mobile applications. While, participants in the control~     group will receive only educational materials. After the intervention, interviews will be~     conducted among participants through phone calls.~   "
59059|NCT02793817|"~     The primary objective of the study is to investigate the efficacy and safety of KPI-121 1.0%~     ophthalmic suspension compared to placebo in subjects who have undergone cataract surgery.~   "
59060|NCT02793804|"~     This study consists of a Cluster Randomised Trial (CRT) of community and facility-based HIVST~     distribution by the Society for Family Health (SFH) in multiple rural and peri-urban~     settings. The study will take place in 6 matched pairs of health facilities and their~     catchment areas have been selected for study inclusion in collaboration with the district~     medical office (DMO). One clinic catchment area from each pair will be randomly allocated to~     the HIVST arm (intervention) and the other to the standard of care (SOC) arm (Control).In the~     HIVST arm, community-based distribution agents (CBDA), including Voluntary Medical Male~     Circumcision (VMMC) mobilisers, will deliver HIVST kits. The kits will also be available at~     the health facility. In the SOC arm, all HIV testing and counseling (HTC) services will be~     conducted as currently.~   "
59061|NCT02793791|"~     The aim of this study is to determine that for hepatic dysplastic nodules in patients with~     chronic hepatitis B, instead of enhanced follow-up, whether early minimally-invasive ablation~     therapy can reduce the incidence of hepatocellular carcinoma.~   "
59062|NCT02793778|"~     The purpose of this study is to evaluate CROWN's efficacy in supporting the repair and~     maintenance of the intestinal mucosa of patients with moderately to severely active Crohn's~     Disease receiving anti-Tumor Necrosis Factor (TNF) therapy (infliximab, adalimumab,~     certolizumab)~   "
59063|NCT02793765|"~     This clinical study will evaluate the role of combination therapy of docetaxel followed by~     Provenge for patients with metastatic castration-resistant prostate cancer (CRPC, (prostate~     cancer that is resistant to medical or surgical treatments that lower testosterone). The~     purpose of this study is to look at the combination therapy of docetaxel followed by Provenge~     to correlate the immunological biomarkers with clinical results for therapy. Biomarkers are~     genes, proteins and other molecules that affect how cancer cells grow, multiply, die and~     respond to other compounds in the body. The study drugs are approved by the Food and Drug~     Administration (FDA).~      Treatment will be administered on an outpatient basis. Patients will receive 6 cycles of~     docetaxel followed by Provenge. Docetaxel is an antineoplastic (chemotherapy that affects~     cancer cell growth) agent. Docetaxel dose of 75 mg/m2 will be given intravenously as a 1-hour~     infusion every 21 days on Day 1 for 6 cycles. Provenge is an immunotherapy (vaccine made from~     patient's own blood cells) that reprograms immune cells to attack cancer. A course of therapy~     consists of three doses of Provenge administered at 2-week intervals.~      The strategy aims to determine whether cytokine production and T cell infiltration of tumor~     cells could favor regression using a combination of chemotherapy plus vaccine. Tissue~     endpoints will include biopsies prior to first chemotherapy and first vaccine therapy and at~     the end of each therapy. Prostate cancer tissue infiltrates will be studied for expression of~     CD3, CD4, CD8, CD25/FOX3P, CD56, CTLA-4, PD-1, and Ki67. Additional immunological endpoints~     will be secondary antigen spread and various cytokine biomarkers.~   "
59064|NCT02793752|"~     The need for non-invasive biomarkers of oocyte competency has become urgent as women~     increasingly delay attempts at childbearing. The aging process is complex and includes~     impaired mitochondrial dysfunction, oxidative stress, diminished metabolic activity, and~     activity of several cell-signaling systems. Cumulus cells form an intimate association with~     the oocyte in the follicle, and they can have a significant impact on oocyte meiotic and~     developmental competence. In the IVF lab, the clump of cumulus cells is typically cut away~     from the oocyte immediately after an oocyte retrieval procedure, and then the cumulus cells~     are discarded. Measuring the mitochondrial respiratory activity of cumulus cells may serve as~     a non-invasive biomarker for oocyte competency and a predictor of reproductive success in IVF~     patients in the future.~   "
59299|NCT02790684|"~     This is a Phase 1, open-label, single-center, non-randomized study to assess the mass balance~     of a single oral dose of DS-8500a in healthy male subjects, 18 years (y) to 60 y of age,~     inclusive. The radiolabeled investigational medicinal product will be administered to 12~     healthy male subjects in 2 cohorts of 6 subjects each.~   "
59065|NCT02793739|"~     Fingers are a part of the body that are often subject to increased signs of aging due to~     physical use, trauma and exposure to the environment. The FDA's recent approval of a dermal~     filler, calcium hydroxylapatite, in hands has led to increased patient demand for hand~     fillers which, in turn, has led to the question of rejuvenation of the dorsal fingers. Due to~     the different anatomy of the fingers than the dorsal hand plus the new demand to improve the~     entire hand plus the finger area, we aim to characterize the best approach. Youthful fingers~     are devoid of wrinkles and often have fuller contours thus hiding the knuckles (proximal~     and distal interphalangeal joints). With aging and loss of subcutaneous tissue volume,~     fingers become wrinkled, look more skeletal, almost emaciated, and joints become much more~     prominent, all aesthetic features often disliked by patients. By augmenting the volume in the~     dorsal fingers, it is possible that the visibility of such bony structures will be decreased,~     wrinkles will become smoother, and a more youthful appearance of the fingers will be~     restored.~      There have been no published reports, to these investigators' knowledge, of the use of~     injectable filler into the dorsal fingers for three-dimensional volume correction. The use of~     exogenous hyaluronic acid (HA) filler in the fingers would be off-label. Given that HA filler~     has been used safely and effectively in many areas of three-dimensional volume restoration~     throughout the body, the investigators believe the HA filler may be used to effectively and~     safely correct volume loss in the fingers. The investigators hope that this study will~     present current, state of the art, never before reported technique, safety, efficacy and~     patient satisfaction of HA filler in this region.~   "
59066|NCT02793726|"~     Symptomatic and asymptomatic patients wearing Metal on Metal hip prosthesis will be enrolled~     in the study and periimplant pseudotumors will be searched by means of NMR (Nuclear Magnetic~     Resonance).~   "
59067|NCT02793713|"~     Surgical removal of a tumour in the lung offers the best chance for survival in early stage~     lung cancers. One main criteria of surgical eligibility is the absence of cancer spread to~     the lymph nodes; rendering the staging process extremely important. The evaluation of these~     lymph nodes is thought to be best completed using Endobronchial Ultrasound (EBUS), a~     procedure in which several lymph nodes are sampled and send to pathology to determine whether~     or not it is malignant. More recently, studies have observed that there are clear differences~     in the characteristics of cancerous and benign (non-cancerous) lymph nodes, and so there has~     been great interest in creating a list of criteria that can determine whether a node is~     malignant. This study aims to prospectively validate a previously proposed score based on~     observed characteristics of lymph nodes during an EBUS procedure relating to~     pathology-confirmed results. To test this, the results of the lymph node samples and the~     observed score will be compared for agreement. If the investigators find that the scoring~     system can accurately predict which lymph nodes are cancerous, it would provide the evidence~     to establish the score as a standard procedure during cancer staging.~   "
59068|NCT02793700|"~     Respiratory distress syndrome (RDS) is a life-threatening condition for premature neonates.~     Antenatal glucocorticoids have been used clinically in women with threatened preterm birth to~     accelerate lung maturation for more than 40 years. The current treatment strategy for women~     with threatened preterm delivery is for a standard, one size fits all dosing with either~     betamethasone (BMZ) or dexamethasone. It is well known that pregnancy introduces additional~     variability in response to medication therapy with different physiological changes and~     alterations in the activity of drug metabolizing enzymes. The objective of this project is to~     evaluate the pharmacokinetic (PK), pharmacodynamic, and pharmacogenetic parameters of~     betamethasone (BMZ) and determine the differences in response and benefit in pregnancy. An~     individualized dosing approach to medications in pregnancy, such as BMZ, is crucial to~     optimize efficacy of this important medication.~   "
59069|NCT02793687|"~     A multicenter, prospective, randomized, double-blind, placebo-controlled, parallel group~     study in patients with stroke~   "
59070|NCT02793674|"~     High-flow nasal cannula (HFNC) is a method of non-invasive respiratory support used to~     decrease the effort of breathing (EOB) in patients with a wide variety of respiratory~     diseases in the pediatric intensive care unit. While its use has shown association with~     decreased rates of mechanical ventilation, there is a paucity of data examining its direct~     effect upon objective measurements of EOB. This study will aim to evaluate objective~     measurements of EOB in response to different levels of HFNC support, characterize the natural~     course of respiratory diseases treated with HFNC, evaluate changes in EOB secondary to the~     administration of supplemental medical therapies used in conjunction with HFNC, and compare~     different physiologic metrics for quantifying EOB in patients on HFNC.~   "
59071|NCT02793661|"~     The Strength study aim to evaluate the use of the RenalGuard device to protect the patients~     at high risk to develop acute kidney injury following a complex cardiovascular intervention~     requiring a high volume of contrast.~   "
59072|NCT02793648|"~     The trial aims to treat depression. The incidence of major depression in the elderly accounts~     for between 3.6 and 4.8% and increases to 8 to 37.4% when depressive disorders in general is~     studied. Besides depression in the elderly presents with cognitive impairment, impaired~     physical and social functioning, and predisposes to suicide. These are patients who often~     have multiple conditions and be taking numerous psychopharmacological treatments which~     hinders further treatment. The clinical trial will analyze the improvement in~     neuropsychiatric symptoms through different instruments The Beck Depression Inventory (BDI),~     State-Trait Anxiety Inventory (STAI), Life Events (AV), World Health Organization Disability~     Assessment Schedule 2.0 (WHODAS 2.0), Wechsler Memory Scale (WMS-III), Mini mental state~     examination (MMSE), Clinical Global Impression (CGI) and metabolic changes in the blood test~     measurements; after 12 weeks of antioxidant (Ascorbic acid and Tocopherol) treatment or~     placebo, and then after 24 weeks on active treatment with the antioxidant combination~     (Ascorbic acid and Tocopherol).~   "
59087|NCT02793453|"~     Periodontal diseases are complex chronic pathologies presenting a high prevalence worldwide.~     Etiopathological process involved in initiation and progression of these multifactorial~     diseases are not well understood, explaining the huge clinical forms variability and the~     complexity of the currently used classification of periodontal diseases. Recently, the~     implication of antimicrobial peptides (AMPs) have been suggested as potential track of~     explanation for periodontal diseases pathogeny. The here presented study explore the level of~     expression of genes coding those peptides by studying periodontal smears obtained from~     healthy and periodontitis patients.~   "
59073|NCT02793635|"~     The purpose of this study is to assess the use of Indego as a gait training tool for subjects~     with complete or incomplete paraplegia as a result of spinal cord injury (SCI) who have~     preserved lower extremity function. It is hypothesized that subjects with complete or~     incomplete paraplegia who have preserved their lower extremity function will experience~     functional improvements after gait training with the Indego exoskeleton.~      Subjects will complete a total of fifteen (15) sessions which include a combination of the~     following; Physical Therapy Evaluation, Indego Training, Mid-Way Assessment, and~     Post-Assessment.~      The aim of this study is to measure the impact of gait training with the Indego device on~     body structure, function, and participation. Additionally it will assess the perceptions of~     physical therapists and subjects with SCI on the effectiveness of gait training with the~     Indego exoskeleton in subjects with preserved limited function.~   "
59074|NCT02793622|"~     This will be a double-blinded randomized controlled phase III trial of 782 HIV uninfected~     pregnant women and the children born to them. HIV uninfected women at 12-20 weeks gestation~     will be randomized in equal proportions to one of two intermittent preventive treatment in~     pregnancy (IPTp) treatment arms: 1) monthly sulfadoxine-pyrimethamine (SP), or 2) monthly~     dihydroartemisinin-piperaquine (DP). Both interventions arms will have either SP or DP~     placebo to ensure adequate blinding is achieved in the study. Follow-up for the pregnant~     women will end approximately 6 weeks after giving birth. All children born to mothers~     enrolled in the study will be followed from birth until they reach 12 months of age.~   "
59075|NCT02793609|"~     Randomized trial comparing double balloon catheter for induction of labor between in- and~     outpatient groups.Investigators assess feasibility, clinical effectiveness and patient~     acceptability of outpatient versus inpatient catheter for induction of labor.~   "
59076|NCT02793596|"~     In this study, we will set out to confirm the reliability of epidural waveform analysis (EWA)~     as an adjunct to loss of resistance for obstetrical epidural blocks.~   "
59077|NCT02793583|"~     This research study will evaluate the safety and efficacy of a study drug called TGR-1202 in~     combination with another study drug called ublituximab with or without bendamustine and~     TGR-1202 alone as a possible treatment for Non-Hodgkin's Lymphoma (NHL) that has come back or~     that has not responded to standard treatment.~   "
59078|NCT02793570|"~     Introduction: Native magnetic resonance angiography (MRA) is recommended to assess the~     thoracic aorta during pregnancy, avoiding the risks of ionising radiation and contrast agent~     administration. This guidance is however, based only on consensus opinion supported by~     limited case reports (level of evidence C).~      Aim: To evaluate the feasibility of performing native 3D steady-state free-precession (SSFP)~     MRA in pregnant subjects with inherited aortopathy to guide timing and mode of delivery.~   "
59079|NCT02793557|"~     A study to investigate clinical safety and effect on hair growth of FOL-005 in healthy~     volunteers. The study is divided in two parts, a single ascending dose (SAD) part and a~     multiple dose (MD) part.~   "
59080|NCT02793544|"~     This is a multi-center, single arm Phase II study of hematopoietic cell transplantation (HCT)~     using human leukocyte antigen (HLA)-mismatched unrelated bone marrow transplantation donors~     and post-transplantation cyclophosphamide (PTCy), sirolimus and mycophenolate mofetil (MMF)~     for graft versus host disease (GVHD) prophylaxis in patients with hematologic malignancies.~   "
59081|NCT02793531|"~     Weight loss and muscle wasting commonly occurs in patients with cancer, negatively~     influencing their quality of life, treatment response and survival. Weight changes in~     patients with cancer may be the consequence of energy imbalance and disturbances in protein~     metabolism, poor treatment tolerance, hormonal alterations, systemic inflammation etc. This~     results in body composition modifications in favor of fat gain and/or lean body mass loss in~     early stage cancer. However, in advanced cancer mostly loss of both fat mass and lean mass~     has been found.~      Unfortunately, gains in muscle mass are difficult to achieve. In a previous study of the~     Investigators, a bolus (15 g) of an essential amino acid mixture as present in milk protein~     was able to stimulate whole-body protein anabolism equally and effectively in weight-losing~     patients with lung cancer. This indicates the high potential of proteins with high essential~     amino acids as therapeutic agents to increase muscle mass in these patients. However, the~     dose-response effect to reach optimal whole-body protein anabolism is yet unknown and can~     differ among patients. Therefore, the Investigators would like to study the effects of~     several dosages of a protein with high essential amino acid levels, administered by sip~     feeding, on whole-body protein anabolism in patients with cancer in comparison with healthy~     older adults. Furthermore, the individual protein requirements of cancer patients may be~     established as this is the cornerstone of nutritional support. Specifically to establish 'the~     anabolic threshold', when protein breakdown equals synthesis and the response and the~     relation between protein intake and net protein synthesis are critical.~   "
59082|NCT02793518|"~     Self-defining memories (SDMs) are memories that are still important today to understand who~     the investigators are and participate to the maintain of personal identity. SDMs are also~     linked to our capacity to project ourselves into the future. In bipolar disorder, life events~     play an important role in the course and outcome of the disease. the study is the first to~     investigate SDMs and self-defining future projections in a population of remitted patients~     with bipolar disorder.~   "
59083|NCT02793505|"~     This study aims to better characterize the risk linked to metformin use during pregnancy,~     using a prospective multicentric cohort design enabling a large sample size, in evaluating~     the rate of birth defects after first trimester exposure, as well as several other pregnancy~     related outcomes.~   "
59084|NCT02793492|"~     This is a multi-center, single arm, non-randomized, prospective clinical study using the~     Misago® RX Self-expanding Peripheral Stent for treatment of de novo, restenotic, and/or~     occlusive lesion(s) of the common and/or external iliac artery.~   "
59085|NCT02793479|"~     The aim of this study is to establish a nationwide registry to collect data regarding the~     treatment of Barrett's Esophagus (BE) with radiofrequency ablation. The objective of this~     registry is to increase the number of data and therefore obtain a raise of quality assurance~     and improve outcome and patient security. Furthermore to provide participating physicians~     information and experience for treatment details in the therapy of BE.~   "
59088|NCT02793440|"~     The purpose of this study is to compare the clinical outcome of medical treatment associated~     with lumbar traction and medical treatment alone in the treatment of lumbar disk herniation.~   "
59089|NCT02793427|"~     The objective of the study is to quantify the products of non-enzymatic glycation of proteins~     (called AGEs for advanced glycation end-products) in serum of type 1 diabetic patients~     without clinical complications in order to define the contribution of this markers in the~     long-term monitoring of glycemic control in these patients. The results will define the~     criteria for using these new markers in daily clinical practice for the monitoring of these~     patients~   "
59090|NCT02793414|"~     This is a diagnostic efficacy study to evaluate a set of biomarkers in human breath~     indicative of an acute malaria infection. The investigators plan to enroll 75 malaria~     patients and 175 febrile non-malaria patients in Ethiopia.~      Upon enrollment, blood for malaria RDT, microscopy and PCR will be collected as well as a~     breath sample to assess the presence of biomarkers at a reference center. Malaria patients~     identified by microscopy are revisited at day 2 and 7 to collect a further samples. G6PD~     testing will be performed concurrently to identify prevalent G6PD variants.~   "
59091|NCT02793401|"~     The investigators aimed to evaluate the short-term efficacy of High Intensity LASER Therapy~     (HILT) and Ultrasound (US) treatment in chronic shoulder pain. It's a prospective,~     randomized, controlled, single blind study.141 patients were randomized into two groups, as~     HILT (n=71) and US (n=70) groups. HILT or US treatment was applied to the patients in~     addition to 14 sessions of Hotpack (Hp) + Balneotherapy + Exercise treatment. Pre-treatment~     (Pre-T), Post-treatment 1st day (Post-T1st day) and Post-T findings for the 30th day (Post-T~     30th day) were recorded using the visual analog scale (VAS) and shoulder pain and disability~     index (SPADI) scoring.~   "
59092|NCT02793388|"~     This is a randomized, controlled, open label trial to assess the effectiveness of~     unsupervised versus supervised primaquine treatment in patients with uncomplicated malaria.~     In co-endemic regions, the risk of P. vivax relapse following treatment for P. falciparum is~     high. Hence patients infected with either P. vivax or P. falciparum will be included in the~     study. The study will be conducted in Ethiopia. Participants will be enrolled at health~     centres and provided with the recommended schizontocidal treatment plus primaquine radical~     cure which will be either supervised or unsupervised according to randomisation. Participants~     will be followed up for four months and assessed at regular intervals for the presence of~     patent and sub-patent malaria. The outcome of the study will contribute to an improved~     treatment scheme for uncomplicated malaria in this area.~   "
59093|NCT02793375|"~     Objective: The purpose of the present study is to evaluate the effectiveness of preoperative~     Montelukast as an analgesic for adenotonsillectomy~      Study Design: Randomized controlled double blinded clinical trial.~      Setting: Cincinnati Children's Hospital Medical Center (CCHMC), Division of Pediatric~     Otolaryngology, Head and Neck Surgery~      Methods: Children between the age of 3-8 undergoing adenotonsillectomy with planned 23 hour~     observation for adenotonsillar hypertrophy and sleep disordered breathing will be randomized~     to receive either montelukast or placebo in Same Day surgery.~      Analysis: Differences in demographics (age, gender, race, weight) between the intervention~     and control groups will be assessed using chi-square (for categorical measures) and t tests~     (for continuous measures). Differences in postoperative opioid usage, postoperative pain~     scores using the FLACC scale, and the number of postoperative contacts (Emergency department~     visits or phone calls) with patients or their family regarding pain or tonsillar hemorrhage~     will be evaluated using chi-square (categorical measures) and t tests (continuous measures).~   "
59094|NCT02793362|"~     The purposes of this study are~        1. To explore effect of sarcopenia on recovery of post stroke hemiplegia~        2. To explore the effect of stroke on sarcopenia and relationship between the degree of~          sarcopenia and respiration and swallowing function~        3. To quantify and qualify post stroke loss of muscle mass~        4. To validity the use of echointensity and elastography in evaluation of sarcopenia.~      By reaching the above list purposes, sarcopenia can be viewed as one of serious post stroke~     complications that is closely related to worth functional outcome, thereby emphasizing the~     importance of evaluation of sarcopenia as well as its prevention.~   "
59095|NCT02793349|"~     ABSORB BTK Study: A prospective, multicenter, controlled clinical evaluation of the use of a~     bioresorbable drug eluting stent in the arterial vasculature below the knee~   "
59096|NCT02793336|"~     Malaria remains an important cause of illness in young infants. Our clinical and~     epidemiological studies in Papua (Indonesia) have shown the magnitude of malaria morbidity in~     infants in the first 5 years of life, including recurrent episodes of malaria, anaemia,~     malnutrition and coinfection. Together these contribute significantly morbidity in early~     life, and almost certainly to the very high infant mortality rates in this region. However~     the body of knowledge around infant malaria outside of Africa, where both species P. vivax~     and P. falciparum are prevalent is considerable smaller. The impact of recurrent vivax~     malaria and severe anaemia on neurodevelopment and growth in young children is unknown in~     Papua.~      This study therefore aims to provide longitudinal data on the incidence of symptomatic and~     asymptomatic malaria (P. falciparum and P. vivax) and the associated risk of anaemia. It also~     provides an opportunity to assess incidence risk of non-malaria febrile illnesses and~     bacterial co-infections and the long term outcomes in terms of neurodevelopment and growth in~     a vulnerable age group. The study is a continuation from two already established cohort~     studies: STOP MIP, which enrolled pregnant women and followed them until delivery and a~     baby-cohort, which enrolled babies from mothers included in the cohort and followed them~     through their first year of life. Continuous follow up of those babies until they are 4 years~     old will increase our understanding of long term impact especially of vivax malaria. The~     cohort will be linked to a randomized controlled trial (RCT) and will offer cohort patients~     to be enrolled into the RCT when they are diagnosed with malaria (symptomatic), allowing to~     estimate treatment effectiveness.~   "
59097|NCT02793323|"~     Shoulder pain is frequently mentioned in recent literature following laparoscopic operations.~     Several pain relief strategies have been proposed to decrease shoulder tip pain post~     laparoscopic surgeries. This study will be conducted to compare the Superficial cervical~     nerve block vs. NSAIDs in terms of shoulder tip pain relief after laparoscopic surgeries.~   "
59098|NCT02793310|"~     The purpose of this study is to determine whether corneal transplantation by Descemet~     Membrane Endothelial Keratoplasty more favourable and cost-effective is compared to Descemet~     Stripping Automated Endothelial Keratoplasty for Fuchs Endothelium Corneal Dystrophy.~   "
59099|NCT02793297|"~     The overall objective is to evaluate the impact of sourdough fermented crisp bread on effects~     on appetite and postprandial glucose and insulin responses. Beneficial effects on appetite~     and postprandial insulin responses have been observed, particularly for unfermented rye crisp~     breads in a previous study. In the present study, the investigators evaluated how the intake~     of sourdough fermented rye crisp breads vs. unfermented rye crisp bread as well as a control~     refined wheat crisp bread product may affect self-rated appetite and postprandial insulin and~     glucose responses in healthy men and women in a meal-study. The investigators characterized~     intervention products with regards to microstructural and chemical features in order to~     elucidate underlying mechanisms for potential effects observed on appetite and postprandial~     metabolic responses.~   "
59100|NCT02793284|"~     The investigators are attempting to determine if a new form of imaging called 18F-DCFPyL~     PET/CT is helpful to physicians in deciding how to manage suspected prostate cancer~     recurrence. This imaging uses a Positron Emission Tomography/Computed Tomography (PET/CT)~     scan using a radioactive tracer 18F-DCFPyL that is concentrated in prostate cancer cells and~     can potentially identify cancer cells throughout the body. The combination of 18F-DCFPyL~     PET/CT can potentially identify areas of prostate cancer recurrence not seen with usual~     imaging [bone scan, computed tomography (CT) thorax, abdomen and pelvis, plus~     multi-parametric magnetic resonance imaging (MRI)].~   "
59101|NCT02793271|"~     A growing number of trials have demonstrated treatment effectiveness for people with mental~     illness (PWMI) by non-specialist providers, such as primary care and community health~     workers, in low-resource settings. A barrier to scaling up these evidence-based practices is~     the limited uptake from trainings into service provision and lack of fidelity to~     evidence-based practices among non-specialists. This arises, in part, from stigma among~     non-specialists against PWMI. Therefore, interventions are needed to address attitudes among~     non-specialists. To address this gap, REducing Stigma among HeAlthcare Providers to improvE~     Mental Health services (RESHAPE-mh), is an intervention for non-specialists in which social~     contact with PWMI is added to training and supervision programs. A pilot cluster randomized~     control trial will address primary objectives including trainees' perspectives on perceived~     acceptability of PWMI's participation in training and supervision, intervention fidelity and~     contagion, assessment of randomization, and feasibility and psychometric properties of~     outcome measures in a cluster design. Secondary objectives are change in provider and patient~     outcomes. The control condition is existing mental health training and supervision for~     non-specialists delivered through the Programme for Improving Mental Healthcare (PRIME),~     which includes the mental health Global Action Programme (mhGAP) and psychosocial treatments.~     The intervention condition will incorporate social contact with PWMI into existing PRIME~     training and supervision. Participants in the pilot will be the direct beneficiaries of~     training and supervision (i.e., primary care workers) and indirect beneficiaries (i.e., their~     patients). Primary care workers' outcomes include knowledge (mhGAP knowledge scale), explicit~     attitudes (mhGAP attitudes and social distance scales), implicit attitudes (Implicit~     Association Test), and clinical competence (Enhancing Assessment of Common Therapeutic~     factors, ENACT) to be assessed pre-training, post-training, and at 4-month follow-up. Patient~     outcomes include functioning, stigma experiences in accessing care, and depression/alcohol~     use symptoms to be assessed at initiation of mental health care and 6 months later. The pilot~     study will assist in modifying the intervention to inform a larger effectiveness trial of~     RESHAPE to ultimately improve provider attitudes and clinical competence as a mechanism to~     improve patient outcomes.~   "
59102|NCT02793258|"~     Background: transcranial direct current stimulation (tDCS) is an innovative treatment for~     major depression. However, its mechanisms of action are still unclear. Major depression is~     characterized by impaired processing of emotional information, which returns back to normal~     after successful antidepressant treatment. In this randomized double-blind study, the~     investigators aim to assess the effect of tDCS on emotional processing in major depression.~   "
59103|NCT02793245|"~     The clinical use of double lumen tubes and bronchial blockers requires a thorough knowledge~     of the tracheobronchial anatomy in order to establish the best choice for the patient. The~     literature is limited regarding major bronchi dimensions. In addition, the measurement method~     is not always adequate or properly described and some publications have evaluated only the~     left bronchial diameter. Computed tomography with 3D reconstruction, technical reference, has~     been little used.~      The project is to conduct a prospective study to compare patient characteristics (age,~     height, weight, gender, smoking, sign of chronic obstructive pulmonary disease (if~     available), and dimensions of the trachea and of the main bronchi from CT scans with 3D~     reconstruction.~   "
59104|NCT02793232|"~     This study will test the safety, tolerability and blood concentrations of single and multiple~     oral doses of PF-06751979 in health subjects and healthy elderly subjects. PF-06751979 is~     being developed for the treatment of Alzheimer's disease.~   "
59105|NCT02793219|"~     This clinical study will evaluate the role of combination therapy of Provenge followed by~     docetaxel for patients with metastatic castration-resistant prostate cancer (CRPC, (prostate~     cancer that is resistant to medical or surgical treatments that lower testosterone). The~     purpose of this study is to look at the combination therapy of Provenge followed by docetaxel~     to correlate the immunological biomarkers with clinical results for therapy. Biomarkers are~     genes, proteins and other molecules that affect how cancer cells grow, multiply, die and~     respond to other compounds in the body. The study drugs are approved by the Food and Drug~     Administration (FDA).~      Treatment will be administered on an outpatient basis. Patients will receive Provenge~     followed by 6 cycles of docetaxel. Provenge is an immunotherapy (vaccine made from patient's~     own blood cells) that reprograms immune cells to attack cancer. A course of therapy consists~     of three doses of Provenge administered at 2-week intervals. Docetaxel is an antineoplastic~     (chemotherapy that affects cancer cell growth) agent. Docetaxel dose of 75 mg/m2 will be~     given intravenously as a 1-hour infusion every 21 days on Day 1 for 6 cycles (21 days).~      The strategy aims to determine whether cytokine production and T cell infiltration of tumor~     cells could favor regression using a combination of vaccine plus chemotherapy. Tissue~     endpoints will include biopsies prior to vaccine therapy and chemotherapy and at the end of~     therapy. Prostate cancer tissue infiltrates will be studied for expression of CD3, CD4, CD8,~     CD25/FOX3P, CD56, CTLA-4, PD-1, and Ki67. Additional immunological endpoints will be~     secondary antigen spread and various cytokine biomarkers.~   "
59116|NCT02793076|"~     The purpose of this mixed methods study is to evaluate the effects an 8-week group dance~     intervention can have on body image and posture in breast cancer survivors.~   "
59117|NCT02793063|"~     The purpose of this study is to explore the patient perspective of disease burden in~     Osteogenesis Imperfecta (OI). Participants will complete a web-based survey of questions~     which are usually administered within the Patient-Reported Outcome Measurement Information~     System (PROMIS) and provide feedback regarding the appropriateness of the questions for~     someone with OI.~   "
59118|NCT02793050|"~     This is an independent, observational, retrospective post marketing study on the use of~     trabectedin in a clinical setting.~      A data collection on the clinical use of the drug will help to improve knowledge and might~     contribute to optimize the clinical use of the drug.~   "
59119|NCT02793037|"~     Trial Design - Objectives and Purpose The aim of this study is to perform a proof of concept~     for the successful retention and outcome measures of zirconia RBBs for the replacement of~     missing canine or posterior teeth (6-8mm span) and that they will exhibit similar survival~     rates (95%) as metal ceramic RBBs over 3 years and short term (Botelho 2006).~      The use of monolithic extra-coronal zirconia RBBs in the posterior region does not appear to~     have been reported in the literature (A search pf Pub Med and Google Scholar has not shown~     any similar studies that have been published - pubmed.gov; Keywords: zirconia, resin,~     clinical assessed on 17/10/2015 AND google scholar; Keywords: zirconia, resin bonded~     fixed partial denture, resin bonded fixed dental prosthesis, Maryland, resin bonded~     bridge posterior, clinical) In addition, currently there appear to be no clinical trials~     planned or finished in this area (clinicaltrial.gov; Keywords: zirconia, resin assessed~     on 17/10/2015) using zirconia RBBs in the posterior region. This reveals that there is a gap~     in the literature on the use of zirconia for replacing posterior teeth with such prostheses.~      The primary outcome measures would be: success ie. prosthesis retention ie. does not fall out~      The secondary outcome measures would be:~        -  complications of the prosthesis such as tipping, drifting or fracture.~        -  patient centered outcomes (satisfaction and oral health related quality of life) on the~          RBBs The hypothesis is that 2-unit cantilevered zirconia RBBs will be as successful as~          current data on 2-unit cantilevered metal-ceramic RBBs from this centre and that there~          will be no difference in the patient centered outcomes.~      The Primary review appointments will be at 1, 6, 12, 24 and 36 months. However, longer term~     follow up will be performed and this centre has experience of such long term studies (9.5~     years - Botelho 2014).~      A randomized clinical trial (RCT) comparing to metal-ceramic RBBs will NOT be performed as~     the 5-year success rate of both metal-ceramic (Botelho 2006) and anterior zirconia (Sasse~     2014) prosthesis were higher than 95% and this small differences would mean an unattainable~     large sample size in an equivalence test (Burns 2001).~      Significance and implications Zirconia has significant strength and greater stiffness than~     base metal alloys and displays clinical outcomes comparable to metal-ceramic conventional~     crowns and bridges (Heintze 2010, Sailer 2007). Well polished zirconia has been observed to~     have lower wear rates than porcelain (Stober 2014) Zirconia RBBs for posterior tooth~     replacement will offer an esthetic and biocompatible treatment option to patients over the~     traditional ceramic-metal RBBs. It is anticipated that patient demand for this would be high~     as these prostheses should be as successful (retentive).~      These results would re-write established dental prosthodontics textbooks and this would be~     the first centre to report on the routine use of a 2-unit extracoronal all-zirconia RBB for~     the replacement of missing posterior teeth.~      Research plan and methodology The sample pool would be obtained from patients presenting at~     the Prince Philip Dental Hospital, University of Hong Kong and who request and need~     replacement of one or more missing teeth.. They will be clinically assessed for eligibility~     and invited to participate with written consent in the study. After treatment they will be~     reviewed up to a 3rd year endpoint of the study. Further review beyond this will be~     undertaken.~   "
59106|NCT02793206|"~     Optic nerve head Drusen are a mostly bilateral change of the optic nerve, eventually causing~     a slow, but progression loss of the visual fields. Characteristic are the crystalline~     deposits at the entrance of the optic nerve, the so called optic disc. The material consists~     of calcium, calcium phosphate, iron, but also amino acids and polysaccharides.~      The diagnose is made or confirmed by different imaging modalities like ultrasound and~     auto-fluorescence imaging. By using the high-resolution imaging with spectral-domain optical~     coherence imaging (SD-OCT) the volume and deposits at the optic disc can be measured and~     quantified.~      The purpose of this study whether and how defects in the visual fields are related to the~     deposits. Multimodal imaging of the optic nerve head is planned within the cross-sectional~     study, at two different time intervals (2 years). Changes in retinal fibre layer (RNFL)~     thickness and disc parameters are analyzed. Presence and extent of auto-fluorescent changes~     are evaluated. The prospective trial wants to clarify whether certain parameters at baseline~     indicate the further outcome and development.~   "
59107|NCT02793193|"~     The gut-brain axis is described as being important in both, gut functions and central nervous~     system (CNS) functions. The microbiota in the gut plays an important role in this axis~     through neural, immune and endocrine systems. Previous studies have found altered gut~     microbiota (GM) composition could change the CNS functions in animals and humans. Probiotics~     were shown having positive effect on improving stress response in animals and stress related~     psychiatry in humans. The current study will investigate if probiotics can improve response~     to social stress in healthy participants and patients with irritable bowel syndrome (IBS),~     which is a stress-related disease, and whether this probiotic action can be counteracted by~     the locally acting antibiotic, Rifaximin. The investigators will use the Cyberball paradigram~     to induce social stress and magnetoencephalography (MEG) to record neural responses related~     to the social stress. The administration of the probiotics will be a new strategy for both~     the mental health management and treatment of gastrointestinal (GI) disorders in the future.~   "
59108|NCT02793180|"~     In the Middle East and the Gulf, the general population have high cardiovascular risks like~     diabetes, hypertension, smoking and obesity. The average age of a patient with an acute~     coronary syndrome (ACS) event is relatively young compared to Western populations. Women are~     multiparous and the rates of consanguinity marriages are high in this region of the world.~     These risk factors and conditions result in heart failure. Great deal of knowledge is missing~     regarding the influence of these risk factors on heart failure presentation, the causes and~     management of heart failure in ambulatory patients in this region of the world.~   "
59109|NCT02793167|"~     Acute kidney injury (AKI) is common, serious and expensive.It is associated with significant~     mortality, morbidity and increased length of hospital stay.To improve clinical outcomes of~     AKI by early detection and timely referral to the renal,the investigators developed an~     electronic alert system which identifies all cases of AKI occurring in patients over 18~     years.The system was also designed to collect data on AKI incidence one of the biggest~     tertiary hospital in China.~   "
59110|NCT02793154|"~     The primary objective of this study is to compare the effect of albiglutide and exenatide on~     gastric myoelectrical activity (GMA), gastric emptying (GE) and nausea (as measured by visual~     analogue scale [VAS]) in subjects with type 2 diabetes mellitus (T2DM). The study is divided~     in two parts. Part A will characterize the GMA, GE and nausea response to exenatide and~     confirm exenatide as a positive control for Part B. Part B will compare the effects of~     albiglutide and exenatide on GMA, GE and nausea.~      Part A is a single arm, open-label design and all subjects will receive 10 microgram (mcg)~     subcutaneous exenatide twice daily for 5 days. This part will comprise 3 study periods: a~     3-week screening/wash-out, 5-day treatment, and follow-up (within 7 days after the last dose~     of exenatide). The total duration of a subject's participation in Part A will be~     approximately 5 weeks. Once Part A is complete, data will be reviewed and a decision to~     progress to Part B will be made.~      In Part B, subjects will be randomized 1:1 to receive either albiglutide (starting dose of 30~     milligrams [mg] once weekly for 4 weeks, followed by 50 mg once weekly for 4 weeks) or~     exenatide (starting dose of 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for~     4 weeks). The total duration of a subject's participation in the study will be approximately~     15 weeks.~   "
59111|NCT02793141|"~     The International study on NoSocomial Pneumonia in Intensive CaRE (PneumoINSPIRE) is a~     prospective, international, multicentre, observational, cohort study. The study aims to~     provide up-to-date and generalisable information on current worldwide epidemiology and~     clinical practice associated with diagnosis and management of nosocomial pneumonia in~     Intensive Care Unit (ICU) patients.~      PneumoINSPIRE study is endorsed by the European Society of Intensive Care Medicine (ESICM).~   "
59112|NCT02793128|"~     The study is investigating the ability of UroGen's MitoGel™ procedure to treat urothelial~     carcinoma tumors from the upper urinary tract. If this treatment will prove to be effective~     this will lead to the development of a new treatment approach for patients suffering from Low~     Grade Upper Urinary Urothelial Carcinoma (UTUC).~   "
59113|NCT02793115|"~     This study seeks to ascertain the best way to inform patients about their physicians'~     conflicts of interest (COI) with industry. Currently, there is no institutional or national~     standard for such physician-to-patient disclosures. The primary aim of this study is to test~     different written disclosures and assess their impact on patients' knowledge of their~     physicians' COIs and on patients' trust in their physician and their healthcare institution.~     The secondary aim is to investigate whether physician disclosures of significant financial~     industry relationships are desired by patients and whether disclosures impact patients'~     knowledge, perceptions, and behaviors. The tertiary aim is to investigate physicians' current~     practices of disclosure and perceptions about the risks, benefits, and feasibility of using~     patient disclosures to manage financial relationships, and to determine whether any physician~     fears are borne out in practice once disclosures are implemented.~   "
59114|NCT02793102|"~     In the literature the use of olfactory dimension in the treatment of anorexia has not been~     verified experimentally. The investigator hypothesize that the therapeutic use of a dietary~     nature olfactory stimuli in anorexia nervosa promotes food recovery. The team propose a~     prospective study over a period of 12 months in which we use the Body Mass Index (BMI) as the~     primary endpoint of the state of anorexia nervosa patients.~   "
59115|NCT02793089|"~     This study evaluates the increased risk of ectopic pregnancy associated with marked variation~     of estradiol during the early luteal phase and high progesterone on hCG day in IVF.~   "
59120|NCT02793024|"~     The objective of this project is to develop and test the effectiveness of a Cooperative~     Extension enhanced intervention titled Smart Shopping, aimed at improving the shopping~     practices of adolescents with the ultimate goal of increasing fruit and vegetable intake. To~     achieve this goal, the investigators will conduct formative research (Year 1) via a~     community-wide analysis of the school, home and neighborhood food environments. In~     collaboration with Extension staff and faculty, this formative research will provide insight~     into the development and enhancement of the Smart Shopping curriculum (adapted from the~     Cooking Matters Extension curriculum, Year 2). In Years 3-4, the investigators will~     implement a randomized controlled intervention trial to examine the effectiveness of the~     developed intervention Smart Shopping to improve adolescents' purchasing and consumption~     behaviors. The investigators will implement the trial in Year 3, and evaluate results in Year~     4. Our education component will include training of University dietetics interns, graduate,~     and undergraduate students to implement and evaluate the intervention with oversight by~     project staff as part of their service learning requirements. This project is unique as it:~     1) takes into account the role that school wellness policies and school environment have in~     food procurement during the day; 2) incorporates information from multiple levels of the~     social ecological framework (home, school, and community food environments, as well as the~     social influence of peers) to create an intervention that addresses influences on adolescents~     purchasing and consumption behaviors where they live and learn; 3) collaborates with~     Extension faculty and staff while enhancing an existing program; 4) utilizes and hones the~     skill sets of students in undergraduate and graduate level nutrition and dietetics programs.~   "
59121|NCT02793011|"~     The investigators will use a prospective randomized, controlled design utilizing a single~     preoperative dose of oral dexamethasone or placebo to achieve these specific aims:~        -  Specific Aim 1: To evaluate the potential for a single preoperative dose of oral~          dexamethasone administered the night before surgery to reduce the incidence and severity~          of early post tonsillectomy pain (PTP) in children~        -  Specific Aim 2: To prospectively evaluate differences in early PTP experience between~          overweight/obese children and their lean peers.~        -  Specific Aim 3: To determine whether circulating inflammatory markers are strongly~          linked to PTP severity in children and whether they could be potential contributors to~          the higher pain experienced by overweight/obese children following Tonsillectomy and or~          Adenoidectomy.~   "
59122|NCT02792998|"~     The objectives of this study are:~      Stage 1: To assess the safety, tolerability, pharmacokinetic (PK) profile and pharmacodynamic~     (PD) effects of a range of doses of IW-1701 tablets administered orally to healthy subjects~     over 7 days of repeated dosing~      Stage 2: To assess the safety, tolerability, PK profile and PD effects of IW-1701 tablets~     administered orally to healthy subjects, in fed and fasted states, in an open-label,~     single-dose, 2-period, 2-sequence crossover study.~   "
59123|NCT02792985|"~     The objective of this Phase II trial is to evaluate the feasibility of this study protocol to~     progress to a large-scale Phase III RCT in the future. It will also determine, with limited~     efficacy, the effectiveness of the multisensory stimulation intervention protocol to reduce~     the duration of post-traumatic amnesia (PTA), improve cognition, increase independence in~     activities of daily living and long term quality of life of the affected person.~      Participants will be randomised into either the experimental or control group. The~     experimental group will follow the multisensory stimulation intervention protocol, while the~     control group will follow the current hospital protocol.~   "
59124|NCT02792972|"~     Context: Research on natural products with therapeutic, analgesic or antimicrobial purpose~     should be encouraged to create new drugs. Acmella oleracea, typical plant of the Northern~     region of the country and popularly known as jambu, has aroused the interest of researchers~     because of its therapeutic potential. Objective: To evaluate the potential topical analgesic~     and antimicrobial of Acmella oleracea plant extract from the skin antisepsis in venipuncture~     procedures. Methods: This is a clinical, randomized, controlled trial with healthy volunteers~     recruited at the Clinic I of the collection of biological materials sector of the Hospital~     das Clinicas Samuel Libânio, in Pouso Alegre-MG. The plant extract A. oleracea manipulated~     with Transcutol® and 70% alcohol were used in the volunteers before the venipuncture~     procedure as allocation in study groups. Held collection of skin microbiota by the swab~     technique and the end of the venipuncture procedure was applied to the volunteer, the visual~     numeric scale (VNS) standard to determine the degree of pain.~   "
59125|NCT02792959|"~     This study evaluates the therapeutic response by modern FMRI and PET techniques with the~     perspective to exploit multimodal data (fusion MRI/PET). The Sponsor would like to optimize~     the respective performances and to define the early assessment criteria, at the first detox,~     of the treatment efficacy, with and without antiangiogenic agent.~   "
59126|NCT02792946|"~     Compare the efficacy and safety of surfolase CR tablet with surfolate capsule in patients~     with acute bronchitis~   "
59127|NCT02792933|"~     Epidural space localization using loss of resistance technique with air (ALOR) is~     controversial in obstetric analgesia due to a minor efficacy and risk of complications,~     compared with loss of resistance technique with saline (SLOR). This randomized prospective~     study will compare the efficacy and incidence of most common complications of both techniques~     in obstetric analgesia.~   "
59128|NCT02792920|"~     To compare early and late clinical outcomes with everolimus-eluting cobalt-chromium stent in~     patients with ST-elevation acute myocardial infarction, as well as identify the~     characteristics and efficacy of CoCr-EES.~      Also, OCT sub-analysis will be conducted~   "
59129|NCT02792907|"~     Compressive stockings ameliorate functional outcome and quality of life in patients after~     elective orthopedic foot and ankle surgery. In this randomized controlled trial the~     investigators want to analyze the effect of compressive stockings after foot and ankle~     surgery. Additionally the investigators want to evaluate the compliance of the compressive~     stockings Treatment. Therefore an electronic chip device is implanted into the compressive~     stockings to monitor wearing time.~   "
59147|NCT02792673|"~     The study design is a prospective randomized uncontrolled clinical trial. It will include 150~     cases.~      The aim of this study is to compare the efficacy of three different media used for embryo~     transfer regarding chemical and clinical pregnancy rate, implantation rate and ongoing~     pregnancy and miscarriage rates in IVF and ICSI cycles.~      The three different embryo transfer media are:~        1. Hyaluronan-enriched medium Embryo Glue®~        2. 30% Protein-supplemented Culture medium Global Total®~        3. Autologous Follicular Fluid (a Novel technique) In order to establish the optimal media~          for embryo transfer~   "
59148|NCT02792660|"~     This is clinical feasibility study on the device performance with paediatric patients. The~     main objective is to validate the performance of investigational device in distinguishing and~     identifying the cerebrospinal fluid (CSF) inside the subarachnoid space during a lumbar~     puncture on paediatric patients.~   "
59130|NCT02792894|"~     Over 6% of children in Pakistan suffer from a developmental disorder (intellectual disability~     or Autistic spectrum disorder) and most receive no intervention.In an earlier proof of~     concept study, the investigators integrated social, technological and business innovations to~     develop and successfully pilot a sustainable service for such children in one rural~     population of 30,000. Affected families were identified through a mobile phone-based~     interactive voice response system, and organised into family networks. 'Champion' family~     volunteers were trained in evidence-based interventions. A Tablet-based android application~     was developed for training, monitoring and supervision of the champions, based on the World~     Health Organization's guidelines. The champions delivered the intervention to other families~     in the network. The project was sustainable and demonstrated significant improvements in the~     lives of children and their families in the first 6 months of its operation. The~     investigators are scaling-up this intervention to a population of 1 million. The~     investigators aim to evaluate the effectiveness and cost effectiveness of the scaled-up~     programme using cluster randomized control trial nested within the scale-up study.~   "
59131|NCT02792881|"~     The purpose of this study is to explore the safety, feasibility, long-term and oncological~     outcomes of laparoscopic total gastrectomy for remnant gastric cancer.~   "
59132|NCT02792868|"~     Study a sample of patients in primary prevention, moderate cardiovascular risk (n = 83~     patients), with normal, non-diabetic renal function. The investigators quantify the~     phophocalcic intake and excretion, realizing a food examination and a urine collection of 24~     particular. The investigators will measure plasma levels of FGF23 serum calcium,~     phosphatemia, the investigators will calculate the tubular reabsorption of phosphate. The~     investigators will conduct a quantitative assessment of coronary calcification by a~     non-injected CT scan, measuring semi automated way Agatston calcium score. There will be an~     analysis of collinearity. An adjustment will be made for confounding variables in a~     generalized linear regression model.~   "
59133|NCT02792855|"~     The simple head extension is recommended for optimization of glottic visualization during~     awake orotracheal intubation whith fiberoptic bronchoscope (FOB) . However, no study to date~     has conﬁrmed its superiority over snifﬁng position . In a prospective, randomized study,~     the authors compared the snifﬁng position with simple head extension in awake orotracheal~     Intubation~   "
59134|NCT02792842|"~     The purpose of this study is to evaluate the efficacy and safety of ART-123 for the~     prevention of cancer treatment related symptoms in patients with postoperative stage II / III~     colon cancer.~   "
59135|NCT02792829|"~     The study will be conducted in adult healthy participants and will consist of two phases:~     Prerandomization and Randomization. The Prerandomization Phase will consist of 2 periods: a~     Screening Period and a Baseline Period. The Randomization Phase will consist of 2 Periods~     (each 6 days long) separated by a 1-day long Baseline Period and End of Treatment (EOT)~     Period. A total of 60 participants will be enrolled into one of three arms. Arms 1 and 3~     consist of 2 sequences, and Arm 2 consists of 4 sequences (as this is an incomplete block~     design with 2 factors [number of capsules and whether water or apple juice is used as~     vehicle]). Each participant will be randomized into one of 8 sequences.~   "
59136|NCT02792816|"~     Efficacy and safety of the artemisinin combination therapy (ACT) in uncomplicated falciparum~     malaria patients in Myanmar and artemisinin molecular markers analysis~   "
59137|NCT02792803|"~     The purpose of the study is to provide evidence that the efficacy of Xalatan will be superior~     to Apo-latanoprost and Co-latanoprost in the reduction of intraocular pressure in patients~     with primary open angle glaucoma. The study will also aim to prove the tolerability of~     Xalatan in terms of ocular hyperemia will be equivalent to its generic counterparts.~   "
59138|NCT02792790|"~     The investigators will prospectively evaluate tissue samples obtained from patients~     undergoing carpal tunnel release surgery for amyloid in the soft tissue that is removed.~     Patients who have tissue that stains positive for amyloid will undergo cardiac testing to~     look for evidence of cardiac involvement.~   "
59139|NCT02792777|"~     The goal of this study is to improve the methods with which researchers identify patient~     centered outcomes for use in research. Specifically, the investigators will test the~     application of concept mapping as compared to one-on-one interviews as a comprehensive and~     efficient method of identifying patient-important outcomes for use in research.~   "
59140|NCT02792764|"~     This study is to collect current information on complications rates of subjects undergoing~     chemotherapy administration through Ports and peripheral IVs.~   "
59141|NCT02792751|"~     Objective Endoscopic Retrograde Cholangiopancreatography (ERCP) is performed for resolving~     cholestasis by sphincterotomy and/or stone extraction and is done with deep sedation or~     general anesthesia. The investigators primary outcome was to evaluate the effects of the~     depth of anesthesia on oxidative stres provided via Bispectral Index (BIS) monitorisation~     during the ERCP procedure by analyzing the biochemical parameters. And their secondary~     outcome was the effects of anesthesia depth on propofol consumption and postoperative~     sedation status.~   "
59142|NCT02792738|"~     The purpose of this protocol is to test the effect of hypnosis on laboratory dyspnea.~   "
59143|NCT02792725|"~     The treating physician/investigator contacts Lilly when, based on their medical opinion, a~     patient meets the criteria for inclusion in the expanded access program.~   "
59144|NCT02792712|"~     Therefore, in this study, we try to evaluate the impact of clopidogrel loading dose 300mg vs.~     ticagrelor 180 mg on myocardial injury as measured by contrast-enhanced magnetic resonance~     imaging (CE-MRI) in STEMI patients undergoing primary PCI.~   "
59145|NCT02792699|"~     This trial is designed to determine what effects the human body has on the investigational~     medicine, ABP 798, and what effects the body has on the investigational medicine after you~     have been given it, and if this is comparable to what is seen for the licensed medicine,~     rituximab, in patients with moderate or severe RA.~      This study will assess if the investigational medicine is safe and effective in treating~     moderate or severe RA compared to the licensed medicine.~   "
59146|NCT02792686|"~     This study is an open label, parallel group, single ascending dose, exploratory study~     performed in a single site (Centre Cap, Montpellier, France).~   "
59149|NCT02792647|"~     The purpose of this study is to investigate the safety and tolerability of IX-01 after~     multiple doses, and to determine the PK of IX-01 and activity of CYP3A4.~   "
59150|NCT02792634|"~     Obesity and obesity related health problems are globally recognized as one of the major~     threats to public health. Bariatric surgery is the most effective and durable therapy option~     for obesity and the improvement of obesity related co-morbidities. Non alcoholic~     steatohepatitis (NASH) is an important comorbidity of obesity and improves after surgical~     intervention. In this study investigators try to enlighten the weight independent mechanism~     for the effects of bariatric surgery. Patients who are assigned to a bariatric procedure will~     be observed for at least 24 month. A liver and adipose tissue samples are gained during the~     operation. Liver function and morphology are observed before and after operation with LiMAx,~     FibroScan and ultrasound. Systemic inflammation is measured in blood samples before and after~     surgical intervention. In order to check the microbiome stool samples are collected~     throughout the entire observation period.~   "
59151|NCT02792621|"~     As people grow older skeletal muscle gradually becomes smaller and weaker, causing reduced~     mobility and quality of life. To understand and reverse this negative process investigators~     need to find new ways of improving the ability of muscle to perform physical activity. There~     is some evidence that supplements may improve how the mitochondria work, and investigators~     want to explore this idea in more detail, by measuring how the muscles work and respond to~     exercise before and after taking the supplement. This will give us the basic information~     investigators would need to see if this is a useful idea.~   "
59152|NCT02792608|"~     Brain Tumour (BT) survivors struggle with disabling physical, emotional, cognitive and~     psychosocial sequelae. Unfortunately, to-date there has been very limited research into~     rehabilitative interventions for this population. With 55,000 BT survivors in Canada alone1,~     access to effective, evidence-based rehabilitative treatment that would improve BT survivors'~     quality of life (QOL) and capacity to cope is a necessity. Mindfulness-Based Therapy's (MBTs)~     are emerging as a potential treatment to address this need. MBTs are group-based~     psychological treatments for coping with illness or disability, with the goal of improving~     psychological wellbeing. Recent studies have begun to suggest a role for MBTs in addressing~     symptom burden and QOL in the acquired brain injury (ABI) population, a heterogeneous~     population that includes survivors of stroke and traumatic brain injury, as well as BT~     survivors. High quality research including within-subject controlled trials, are needed to~     demonstrate whether MBTs can provide efficacious, accessible and cost-effective treatment to~     improve the lives of BT survivors.~   "
59153|NCT02792595|"~     The study aims to determine the Sun Protection Factor (SPF) of 8 cosmetic products in vivo on~     the back of human participants, according to the International Standard Sun Protection Test~     method by using a sun simulator.~   "
59154|NCT02792582|"~     Craniopharyngioma is a rare brain tumor that affects both children and adults. It arises in a~     region of the brain near the pituitary gland, visual pathways, and central blood vessels.~     Patients often present with headache, loss of vision or delayed growth. In some instances~     they may present with imbalance of water and salts in the body.~      The treatment for craniopharyngioma may be radical surgery or a combination of surgery and~     radiation therapy. In some instances surgery is not required. If the tumor cannot be~     completely removed, radiation therapy may be required. In this study we will use the most~     advanced form of proton therapy which is called intensity-modulated proton therapy. This is a~     newer form of radiation therapy which has a number of advantages over older forms of proton~     therapy and conventional radiation therapy using x-rays.~      The main goal of this study is to learn if proton therapy will effectively treat patients~     with craniopharyngioma brain tumors and reduce side effects compared to more traditional~     forms of radiation therapy.~   "
59155|NCT02792569|"~     The aim of this project is to activate recruitment and growth of resting primordial follicles~     in the ovaries of women with diminished ovarian reserve, in attempt to increase the chance to~     become pregnant, either naturally or after assisted reproduction.~   "
59156|NCT02792556|"~     According to a study of the DREES (Direction de la Recherche, des Etudes, de l'Evaluation et~     des Statistiques), in 2013, nearly 229 000 abortions were performed in France, an increasing~     number.~      The success rate of drug abortion before 49 days of amenorrhea, defined by the National~     Health Autority as a complete abortion not requiring surgery, varies from 92 to 98% depending~     on the pregnancy term and the dose used.~      The control visit is performed between the 14th day and the 21th day post abortion. Its role~     is to monitor the effectiveness of the method, to verify absence of complication and to~     better adapt contraception to prevent another unwanted pregnancy. The choice of the method is~     left to the physician's discretion: β-HCG dosage, pelvic or transvaginal ultrasound.~      In the Orthogenic Departement of the Croix-Rousse Hospital Lyon, France, the method performed~     during the control visit is transvaginal ultrasound.~      To simplify the monitoring of drug abortion, a urine pregnancy test would be an attractive~     alternative to transvaginal ultrasound: simplicity of use, speed, ease of interpretation and~     low cost.~      The main objective of this study is to evaluate the diagnostic value of urine pregnancy test~     CHECK TOP compared to transvaginal ultrasound in monitoring the outcome of drug abortion~     during the control visit.~      This is a monocentric observational study.~   "
59157|NCT02792543|"~     In the case of intestinal failure with a high-output double enterostomy, the parenteral~     nutrition (PN) is the gold standard treatment until the surgical reestablishment of digestive~     continuity. PN has its own morbidity, and in the absence of expertise, the risks of~     infectious, mechanical, and metabolic complications are increased. Chyme reinfusion (CR) is~     an enteral nutritional technique which reestablishes the functional continuity of the~     anatomically present small bowel through an extracorporeal circulation of the chyme. In~     patients with intestinal failure with a temporary high-output double enterostomy, we~     hypothesize that CR, compared to PN will reduce post-operative complications after surgical~     reestablishment of digestive continuity, maintain the intestinal function including~     absorption, and reduce the complications during the transitional period pending the surgical~     reestablishment of digestive continuity.~   "
59158|NCT02792530|"~     This study will evaluate the efficiency of dietary intervention on intradialytic weight gain.~     Uniric hemodialysis patients without serious dietary complications, who accumulate above 2.5~     kg (or above 4%) of their dry weight, will undergo a series of dietary consultations for~     sodium restriction. One month after the intervention, their intradialytic weight accumulation~     will be measured.~   "
59159|NCT02792517|"~     A pharmacokinetic drug interaction study of AMG 334 and an oral contraceptive containing~     progestin and estrogen.~   "
59164|NCT02792452|"~     The management of symptomatic patients with moderate Aortic Stenosis (AS) remains challenging~     and tests that would give more definitive answers are needed. The value of increase in Aortic~     Valve mean Gradient (AVMG), lack of change in Aortic Valve area (AVA) and calculation of~     valve compliance/resistance during stress echo (SE) in the symptomatic moderate AS population~     prognostication has to the investigators knowledge not been examined before. Similarly the~     additive value of myocardial blood flow reserve (MBFR), Computed Tomography (CT) calcium~     score, speckle tracking echocardiography, carotid ultrasonography, and N-Terminal pro B- type~     natriuretic peptide B (NT-proBNP) in the prognostication of this population group especially~     in combination with SE remains unclear.~   "
59165|NCT02792439|"~     America Walks is an observational research study to determine walking behavior of individuals~     in the United States. The entire study will be conducted virtually by requiring participants~     to download a mobile phone application (App), The App will leverage the mobile phone's step~     count sensor technology to automatically determine participants' daily walking activity.~     Participation is voluntary. Participants can choose not to participate or choose to~     participate and then stop participating. Participants decision will not result in any penalty~     or loss of benefits to which they are entitled.~   "
59166|NCT02792426|"~     To better understand the PK and associated pharmacodynamic (PD) responses produced by the~     Research ENDS S-TA-U001 product, this study will compare the Research ENDS S-TA-U001 to~        -  The subject's own brand combustion (non-menthol) cigarette and a U.S. FDA approved~          smoking cessation product, the NICORETTE Inhalator, in current non-menthol cigarette~          smokers who have some limited e-cigarette experience (Group 1).~        -  Commercially available products in current primarily e-cigarette users (experienced ENDS~          users) (Group 2) The PK/PD session for each product will be conducted in a controlled~          clinical setting with frequent PK sampling after 14 hours of supervised abstinence from~          all forms of nicotine. Subjects will familiarize themselves with the Research ENDS~          S-TA-U001 and NICORETTE Inhalator by using each product in the real world for one day~          before the PK/PD session for that product.~      Primary Objectives:~      Group 1 objectives are to characterize the nicotine PK profile (eg, maximum plasma~     concentration [Cmax], time to maximum plasma concentration [Tmax], area under the~     concentration-time curve [AUC], and terminal half-life [t1/2]) for 10 inhalation and ad lib~     sessions of Research ENDS S-TA-U001 and explore how the Cmax compares to a 15 ng/mL level~     during the 4.5-minute 10 inhalation and the 6 hour ad lib use sessions, to compare the PK~     profiles between Research ENDS S-TA-U001 to the profiles of combustion cigarettes measured at~     the baseline session, and to demonstrate superiority of PK profile of Research ENDS S-TA-U001~     to that of the marketed NICORETTE Inhalator.~      Group 2 objectives are to characterize the nicotine PK profile of Research ENDS S-TA-U001 and~     explore how the Cmax compares to a 15 ng/mL level during the 4.5-minute 10 inhalation and 6~     hour ad lib use sessions, and to compare the PK profile between Research ENDS S-TA-U001 to~     the profile of a commercial ENDS product measured at the baseline session.~      Secondary objectives:~      Secondary objectives include comparison of the nicotine PK of the Research ENDS S-TA-U001 to~     the subjects' normal nicotine source (combustion cigarettes for Group 1 or commercial ENDS~     for Group 2), to evaluate the safety and tolerability of Research ENDS S-TA-U001, to evaluate~     the effects on craving and user satisfaction of the Research ENDS S-TA-U001 vs a combustion~     cigarette or the NICORETTE Inhalator (Group 1) or a commercial ENDS product (Group 2), and to~     evaluate various biomarkers following use of each test product.~   "
59167|NCT02792413|"~     Aim of this study is to evaluate in a population of old osteoporotic chronic kidney disease~     females the effect of denosumab:~        -  on bone mineral density (femoral T-score) at 24 months~        -  on bone mineral density evolution (femoral T-score) after 24 months of follow-up~        -  on bone mineral density evolution (lumbar T-score) after 24 months of follow-up~        -  on coronary and abdominal aorta calcification scores evolution after 24 months of~          follow-up~        -  on parameters of bone remodelling (OPG, RANKL, sclerostin, DKK-1), of mineral and~          calcium metabolism (FGF23 Ct, Klotho, PTH, 25(OH) vitamin D3, phosphorus, calcium, bone~          alklaline phosphatase, osteocalcin, CTX), of inflammation (CRP) after 24 months of~          follow-up~        -  on cardiovascular morbidity (cardiovascular events) and mortality after 24 months of~          follow-up~        -  the tolerance after 24 months of follow-up~   "
59168|NCT02792400|"~     In normal physiology, glucagon from pancreatic alpha cells plays an important role in~     maintaining glucose homeostasis via its regulatory effect on hepatic glucose production.~     Patients with type 2 diabetes exhibit elevated plasma glucagon levels in the fasting state,~     and in response to ingestion of glucose or a mixed meal.glucagon, glucagon concentrations~     fail to decrease appropriately and may even increase. This diabetic hyperglucagonaemia may~     therefore contribute importantly to the hyperglycaemia of the patients.~      Several glucose-lowering treatment modalities have been shown to affect glucagon levels in~     patients with type 2 diabetes, but the role of glucagon in the glucose-lowering effects of~     these treatment modalities has been difficult to discern. By using a glucagon receptor~     antagonist (GRA) the investigators will exploit glucagon receptor antagonism to delineate the~     role of glucagon during treatment with sodium-glucose co-transporter 2 (SGLT2) inhibitors and~     dipeptidyl peptidase 4 (DPP-4) inhibitors, which have been shown to increase and decrease~     plasma glucagon levels, respectively.~   "
59169|NCT02792387|"~     The aim of the study is to explore association between increased central venous pressure,~     Ejection Fraction and renal dysfunction (eGFR) in patients with Cardio-Renal Syndromes type 1~     and 2. The pilot study was set to provide the expected correlation coefficient for a sample~     size determination of the subsequent study.~   "
59170|NCT02792374|"~     The objective of this descriptive investigation was to evaluate the psychological profile of~     dental patients in three levels: global level, the dimensional level, and the discrete~     symptom level and to compare it with a control group.~   "
59171|NCT02792361|"~     This is a clinical trial where patients who present to the neurosurgery service in need of a~     procedure that requires a pterional craniotomy will be screened, and if eligible, enrolled~     for the randomization in the placement of a drain at the surgical site. At present, there is~     not a protocol for whether or not to use a drain following this procedure. There is some~     debate on whether it serves any real benefit for the patient or if it may actually be~     detrimental in cases where infection occurs. This study aims to answer this question by~     randomizing patients to drain placement and then comparing patient outcomes between the two~     groups. These include the following: infection rate, length of hospital stay, self-reported~     patient pain and discomfort, the amount of time before patients are able to open their eye~     ipsilateral to the side of operation, change in forehead circumference post-op days 1-3, and~     any unforeseen post-operative complications. This will be accomplished through using a~     patient-administered survey, recording physical measurements, and a patient chart review.~     Statistical analysis will then be used to identify any differences that may exist.~   "
59198|NCT02791997|"~     The project studies auditory processing after brain damage (in temporal and/or frontal areas)~     and in migraine. The auditory processes investigated are attention, short-term memory,~     sound-induced emotions. To characterize auditory deficits after brain damage or in migraine,~     neuropsychological assessments are combined with neurophysiological markers~     (Electro-encephalography: EEG, Magneto-encephalography: MEG, Magnetic Resonance Imaging:~     MRI).~   "
59300|NCT02790671|"~     Study will assess the effects of itraconazole on the pharmacokinetic (PK) parameters of~     single-dose DS-8500a in healthy subjects. This is an open-label study in healthy subjects.~   "
59172|NCT02792348|"~     For the new-born, diagnosis and prognosis of congenital urine flow impairment (UFI) are~     difficult to confirm only with morphological examination (ultrasonography, intravenous~     pyelography) and functional examination (dynamic renal scan MAG3). Only the test of time~     allows the post confirmation of a significant UFI requiring a surgery. This meant that the~     actual therapeutic indications are imperfect by the absence of an absolute endpoint for~     UFI.~      The objective of the study is to characterize the urinary metabolomics profile of new born~     with renal pelvis and/or ureters tract dilatation (suspicion of pelvi-ureteric junction~     anomalies, primary megaureter and vesico-ureteric reflux), detected by prenatal~     ultrasonography, by Nuclear Magnetic Resonance (NMR) and metabolomics analysis. This~     characterization will allow the identification of statistically significant metabolomics~     markers for the diagnosis and prognosis of a favourable evolution of the anomaly. The~     evolution with time of these metabolomics profiles will also considered.~   "
59173|NCT02792335|"~     To describe the rate of discontinuation among Non-Valvular Atrial Fibrillation (NVAF)~     patients who were on warfarin and have switched to the Novel oral anticoagulants(NOACs).~   "
59174|NCT02792322|"~     This study is designed to investigate if transoral surgery with the patient in the seated~     position utilizing the da Vinci&#174; Robotic Surgical System (Intuitive Surgical, Inc.,~     Sunnyvale, CA) will enable better visualization and expedited removal of benign and malignant~     tumors of the throat.~   "
59175|NCT02792309|"~     Mathematica was awarded a contract by ACF to conduct the evaluation of selected grantees~     offering Healthy Marriage and Relationship Education Programs.This particular evaluation will~     focus on the University of Denver's MotherWise program, which offers relationship education~     and other supports to low-income women expecting a baby. The program has three core~     components: (1) 18 hours of core workshop sessions using the Within My Reach relationship~     education curriculum supplemented with content on mother-infant relationships; (2) case~     management services; and (3) optional relationship education workshops for couples. The~     evaluation will test the effect of this full package of services on mothers' relationship~     outcomes, as well as other outcomes related to child well-being, such as co-parenting and~     father involvement.~   "
59176|NCT02792296|"~     This is an open-label study in adults to assess at-home Project: EVO Monitor measurements~     over repeat play cycles. The study has three arms:playing multiple times per day, once daily,~     and once weekly for 4 to 8 weeks.~   "
59177|NCT02792283|"~     The objective is to evaluate the function of the platelet in patients undergoing~     hemodialysis. The investigators will use the assay called PFA-100, an in vitro whole blood~     assay with three pathways of platelet activation to describe a platelet response profile.~      The hypothesis is that patients undergoing hemodialysis present a platelet dysfunction, that~     may be reversed by hemodialysis. The effect of heparin, used during hemodialysis session to~     anticoagulate the hemodialyzer, on platelet function will be assessed.~   "
59178|NCT02792270|"~     This study is being conducted to decrease the rate of surgical wound complications. The~     investigators are studying the effects that caloric restriction has on decreasing the rate of~     surgical wound complications.~   "
59179|NCT02792257|"~     Alzheimer's disease (AD) is the most prevalent neurodegenerative disease of aging.~     Neuropsychiatric symptoms (NPS) in AD are a major cause of burden to patients, caregivers,~     and society and are near-universal at some point in the AD course. One of the most troubling~     of these symptoms is agitation (Agit-AD), typified by a variety of problem behaviors~     including combativeness, yelling, pacing, lack of cooperation with care, insomnia, and~     restlessness There is a great need for better interventions that target Agit-AD, a major~     source of patient disability as well as caregiver burden and stress, particularly in the case~     of moderate to severe agitation. This pilot trial could open the door to re-purposing~     Dronabinol (Marinol®) as a novel and safe treatment for Agit-AD with significant public~     health impact.~   "
59180|NCT02792244|"~     Previous studies show that incontinence is relatively common during pregnancy and after~     delivery. Experiencing incontinence during pregnancy or in the first year after delivery~     increases the risk of long term incontinence. There is scarce documentation of the long term~     prevalence of anal incontinence (AI) in Norway. This study aims to explore prevalence and~     risk factors for incontinence approximately six years after delivery among the 1718 who~     participated in two previous studies exploring the prevalence and predictors of anal~     incontinence in late pregnancy and during the first year after first delivery, and the effect~     of pelvic floor muscle exercises as treatment for anal incontinence after delivery. Increased~     awareness and knowledge about risk factors and long term prevalence of anal incontinence~     among health professionals as well as pregnant and parous women may give indications about~     which women to target for preventative measures to reduce the risk of new onset of postpartum~     AI during pregnancy and after delivery. Further, increased knowledge may aid in planning~     individualized follow-up during pregnancy and the first year as well as in the long term~     among women with existing AI symptoms.~   "
59181|NCT02792231|"~     To compare the efficacy and safety of ofatumumab administered subcutaneously (sc) every 4~     weeks versus teriflunomide administered orally once daily in patients with relapsing multiple~     sclerosis~   "
59182|NCT02792218|"~     To compare the efficacy and safety of ofatumumab administered subcutaneously (sc) every 4~     weeks versus teriflunomide administered orally once daily in patients with relapsing multiple~     sclerosis~   "
59195|NCT02792036|"~     Retinoblastoma (RB) is the most common intraocular tumor of childhood. Recurrent or~     refractory disease following therapy most often occurs due to persistence of vitreous disease~     and/or retinal reactivation of the main tumor mass. With this treatment protocol,~     investigators seek to identify a less invasive method of local drug delivery that does not~     disrupt the eye's integrity.~      PRIMARY OBJECTIVE:~        -  To determine the safety and toxicity profile associated with intravitreal carboplatin~          for the treatment of recurrent or progressive intraocular retinoblastoma with vitreous~          seeding.~      SECONDARY OBJECTIVES:~        -  To estimate the ocular salvage rate after treatment with intravitreal carboplatin in~          patients with recurrent or progressive intraocular retinoblastoma with vitreous seeding.~        -  To evaluate the effects of intravitreal carboplatin therapy on the histopathology of~          eyes enucleated for progressive or recalcitrant disease while on therapy.~   "
59196|NCT02792023|"~     Prospective study to test whether the immunochemical fecal occult blood test (FIT) for~     colorectal cancer (CRC) helps to prioritize patients with iron deficiency anemia for~     colonoscopy.~   "
59183|NCT02792205|"~     Von Willebrand Disease (VWD) is defined as an inherited bleeding disorder that is caused by~     deficiency or dysfunction of von Willebrand factor (VWF), a plasma protein that mediates the~     initial adhesion of platelets at sites of vascular injury and also binds and stabilizes blood~     clotting factor VIII (FVIII) in the circulation. The most severe forms of VWD are usually~     easy to diagnose (obvious hemorrhagic symptoms and major VWF deficiency), whereas the mild~     forms of the disease are still difficult to confirm. It is indeed reported that about 1% of~     the population carry mild biological VWF deficiency without any bleeding tendency and any~     actual disease. On the contrary, some patients with severe bleeding history can carry a~     true VWF abnormality, well-confirmed by genetic studies, without any VWF deficiency when~     evaluated with standard biological methods, such as Ristocetin Cofactor activity (VWF:RCo).~     However, in these patients, the use of alternative methods, such as PFA-100 (Platelet~     Fonction Analyzer-100), the study of Factor VIII (FVIII:C) to VWF (FVIII:C/VWF) ratio or the~     evaluation of VWF activity using more specialized methods such as VWF:CB (VWF-Collagen~     Binding) assay can detect the VWF deficiency and possible hemorrhagic predisposition.~      In this project, the investigators plan to assess the performance of VWF:CB in the diagnosis~     of VWF deficiency in patients with unexplained bleeding history.~   "
59184|NCT02792192|"~     This Phase Ib/II study is designed to assess the safety, tolerability, pharmacokinetics,~     immunogenicity, patient reported outcomes (PROs), and preliminary anti-tumor activity of~     atezolizumab administered by intravenous (IV) infusion alone and in combination with~     intravesical BCG in high-risk NMIBC participants. The study will be conducted in following~     cohorts: Cohort 1A, Cohort 1B, Cohort 2, and Cohort 3. Atezolizumab will be administered at a~     fixed dose of 1200 milligrams (mg) every 3 weeks (q3w) for a maximum of 96 weeks. BCG will be~     administered to evaluate dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), or~     maximum administered dose (MAD). De-escalation will be allowed for up to three dose levels of~     BCG (full dose [50 mg], 66 percent [%] of a full dose, and 33% of a full dose [Cohort 1B~     only]). After the MTD or MAD is determined for Cohort 1B, this dose will be used for all~     subsequent participants enrolled into Cohorts 1B, 2, and 3, unless the MTD is determined to~     be 33% of a full BCG dose. If MTD is determined to be 33% of a full BCG dose, then, no~     participants will be enrolled into Cohorts 2 and 3 until an assessment of the safety and~     activity of the combination of atezolizumab plus 33% of a full BCG dose is completed.~   "
59185|NCT02792179|"~     This is a longitudinal, follow-up study in participants with Alzheimer's disease (AD) who~     previously participated in study BP29409 (NCT02187627). This study is designed to assess the~     longitudinal change of Tau pathology in the brain of participants with AD using the PET~     ligand [18F]RO6958948 and to assess the safety and tolerability of PET ligand.~   "
59186|NCT02792166|"~     The prevalence of morbid obesity in Canada has risen almost 5 fold in the past three decades.~     Surgery remains the cornerstone of treatment of obesity and related comorbidities such as~     type-2 diabetes. Bariatric/metabolic procedures can be classified into 2 main categories: a)~     those that cause restriction, and b) those that add a malabsorptive component to restriction.~     Currently sleeve gastrectomy (SG), which is a purely restrictive operation, is the most~     frequently performed procedure in North America.~      Interestingly, combined restrictive/malabsorptive procedures such as Roux-en-Y gastric bypass~     (RYGB) or biliopancreatic diversion with duodenal switch (BPD-DS) are more effective~     procedures when compared to purely restrictive ones. Moreover, the conventional BPD-DS~     procedure has been shown to be significantly more effective than RYGB in achieving durable~     weight loss and resolving comorbidities such as type-2 diabetes. Despite superior outcomes,~     the performance of BPD-DS is highly institution dependant and comprises less than 5% of the~     annual bariatric procedures performed worldwide.~      Common reservations against BPD-DS are related to the side effects of the procedure, and~     include frequent bowel movements, flatulence, fat, micronutrient and protein malnutrition.~     Furthermore, longer operative times and surgical technical challenges are also reasons for~     lower prevalence of the BPD-DS procedure.~      Single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) is a modification of~     the conventional BPD-DS that potentially addresses many of these concerns. In addition, it is~     a suitable second-stage or salvage procedure for severely obese patients with inadequate~     weight loss or resolution of obesity-related comorbidities after SG. Despite showing~     excellent results of up to 5 years with acceptable postoperative morbidity, all the~     literature on SADI-S originates from a single center and has not been compared directly with~     BPD-DS. Hence, the investigators aim to evaluate the feasibility, safety, and postoperative~     outcomes of SADI-S as it compares to conventional BPD-DS in morbidly obese patients.~      This project has three specific aims:~        1. To evaluate feasibility and short-term safety of SADI-S.~        2. To evaluate short and long-term beneficial outcomes.~        3. To evaluate and compare long-term morbidity.~   "
59187|NCT02792153|"~     The purpose of this study is to determine whether estrogen may help reduce fear of high~     calorie-density foods in weight-restored women with Anorexia Nervosa (AN).~   "
59188|NCT02792140|"~     In this study, the investigators pose the question which influence the opioid circuit has on~     positive valent situations in dreams.~   "
59189|NCT02792127|"~     The purpose of this study is to investigate the efficacy of an online program in reducing~     symptoms of social anxiety, unhelpful thoughts, avoidance behaviours, fear of negative~     evaluations and improving quality of life in students with above-average social anxiety.~   "
59190|NCT02792114|"~     The purpose of this study is to test the safety of different doses of specially prepared T~     cells collected from the blood. The investigators want to find a safe dose of these modified~     T cells for patients who have metastatic HER2-negative breast cancer.~   "
59191|NCT02792088|"~     To prove that a study drug is noninferior to a control drug with a proportion of subjects who~     showed HBV DNA undetected (less than 400 copies/mL (69 IU/mL)) at the 48th week after 48-week~     administration of Besifovir 150 mg, or Tenofovir 300 mg as a control drug to chronic~     hepatitis B patients~   "
59192|NCT02792075|"~     The purpose of this study is to evaluate the prognosis of coronary stenosis based on~     intracoronary Imaging.~   "
59193|NCT02792062|"~     The purpose of this study is to evaluate food effects on the pharmacokinetics of a single~     oral dose of TAK-385 in Japanese premenopausal healthy adult women.~   "
59194|NCT02792049|"~     Investigators compared tidal volumes for single rescuer ventilation using a modified bag~     valve mask with an integrated internal handle versus a conventional bag valve mask in a~     manikin model.~   "
59197|NCT02792010|"~     Hip osteoarthritis is a frequent and invalidating disease. Early detection of cartilage~     modifications could provide better patient treatment. The T1rho MRI sequence allows the~     quantification of the cartilage signal that is correlated to modifications of the cartilage~     matrix, notably of the proteoglycans. The primary objective is to evaluate normal values of~     hip cartilage in vivo using T1rho MRI in healthy subjects and the reproducibility of the~     measurements. T1rho and T2 mapping sequences were acquired twice during the same session with~     30 minutes interval to see if values were modified after a 30 minutes delay in a supine~     position. The secondary objective was to assess the correlation between T1rho and T2 values.~   "
59199|NCT02791984|"~     Respiratory changes in aortic blood velocity have been described as an indicator of fluid~     responsiveness when measured in the left ventricular outflow tract by trans esophageal~     echography. A threshold value of 12% allowed discrimination between responders and~     nonresponders with a sensitivity of 100% and a specificity of 89%. The suprasternal window is~     already used to measure cardiac output. The primary endpoint of this study is to determine~     the predictive value of the respiratory variability in aortic blood velocity measured by~     suprasternal view (∆VpicSS) as an indicator of fluid responsiveness. The secondary endpoint~     is to compare maximum velocity and velocity time integral measured by suprasternal and~     transthoracic view.~   "
59200|NCT02791971|"~     The purpose of this study is to determine whether delivery of SpeakOut, a behavioral~     intervention to increase social communication about long-acting reversible contraceptive~     (LARC) methods among adolescents, is associated with increased uptake of LARC methods among~     the social contacts of SpeakOut recipients.~      The investigators will conduct a cluster randomized controlled trial of SpeakOut with~     adolescent LARC users and their female peers. Over three years, SpeakOut will be implemented~     in eight partner clinics. IUD and implant users aged 15 to 19 who attend appointments at~     participating clinics will be invited to enroll in the evaluation study as primary~     participants and receive either SpeakOut or a control intervention about alcohol use. The~     social contacts of primary participants will be asked to enroll in the study as secondary~     participants. The study's primary outcome will be the proportion of sexually-active secondary~     participants who initiate use of a LARC method within 9 months of study enrollment.~   "
59201|NCT02791958|"~     This study is to compare the pharmacodynamics of a Fixed Dose Combination Pill AAR~     (acetylsalicylic acid 100 mg, atorvastatin 40 mg and ramipril 10 mg) and the respective~     reference products, atorvastatin (Lipitor®) 40 mg and ramipril (Altace®) 10 mg.~   "
59202|NCT02791945|"~     The goal of the project is to improve the care of Veterans with mild traumatic brain injury~     (mTBI) and unhealthy alcohol use.~   "
59203|NCT02791932|"~     Fifteen percent of women experience depression during pregnancy or postpartum (i.e.,~     perinatal depression). Furthermore, 38% of low income women experience postpartum depression.~     Given few women with perinatal depression seek treatment, there is a need for innovative, low~     cost interventions that can be integrated within existing community-based programs serving~     women in need (e.g., low income women). The primary aim of this study is to examine the~     efficacy of a novel exercise intervention designed to prevent perinatal depression among~     women attending federally qualified health centers serving high risk women.~   "
59204|NCT02791919|"~     This phase I trial studies the side effects and best dose of wee1 kinase inhibitor AZD1775~     when given together with fludarabine, cytarabine, and filgrastim (FLAG) combination~     chemotherapy in treating children, adolescents and young adults with relapsed or refractory~     acute myeloid leukemia. Wee1 kinase inhibitor AZD1775 may help combination chemotherapy work~     better by making tumor cells more sensitive to the drugs. Drugs used in chemotherapy, such as~     fludarabine and cytarabine, may prevent tumor cells from multiplying by damaging their~     deoxyribonucleic acid (DNA), which in turn stops the tumor from growing. Giving wee1 kinase~     inhibitor AZD1775 and FLAG chemotherapy may work better in treating patients with acute~     myeloid leukemia.~   "
59205|NCT02791906|"~     Heart failure (HF) is an epidemic and is a major burden on the US healthcare system. The most~     common cardiovascular endpoint is HF. Thus, novel interventions to prevent HF in CKD are~     highly desirable. This study will assess: the variability in the response to ISMN therapy;~     the degree of change in central hemodynamics and cardiac endpoints through analysis of~     changes in LV mass, diffuse myocardial fibrosis, and myocardial systolic and diastolic~     function.~   "
59206|NCT02791893|"~     The researchers propose studying Gulf veterans with Gulf War Illness (GWI), characterized by~     a problem with widespread pain. Besides their pain, the researchers will also assess the~     effect of vagus nerve stimulation (VNS) in alleviating migraine headache, another complaint~     of Gulf veterans, which is common in the presence of widespread pain. Importantly, the~     researchers are partnering with a company that has made a hand-held device that allows for~     stimulation of the vagus nerve without the need for surgery; it works by the patient putting~     it on the skin overlying the vagus nerve in their neck and then turning it on for 120 second~     periods three times a day. The device is programmed to deliver only 6 bouts of stimulation~     per day - one to each side of the neck three times a day; it is then inactive until the next~     day. The fact that this device can be used without surgery and is non-invasive makes it~     extremely practical for use.~      After collecting pre-treatment measurement of pain severity and headache severity, veterans~     will receive either the actual active VNS device or an inactive device, which does not~     stimulate the nerve. Veterans will use their device for ten weeks - providing similar~     information periodically over this period by responding to questions about the severity of~     their pain and headaches, They will then return to the Center for the final phase of the~     study where all veterans will receive active devices. Ten weeks later, they will return to~     the Center to provide information to allow the investigators to gain further knowledge as to~     the effectiveness of actual VNS in relieving pain - both throughout the body and in the head.~   "
59207|NCT02791880|"~     In the last decade, transcatheter aortic valve replacement (TAVR) has become an increasingly~     utilized alternative procedure for replacing a stenotic aortic valve. This study collects~     clinical information, DNA, blood and urine samples (throughout procedural hospitalization) in~     order to investigate the incidence of acute kidney injury (AKI) in patients undergoing TAVR~     and to identify key clinical and procedural predictors of AKI. This study seeks to identify~     blood and urine biomarkers that can be used for early detection of AKI around the time of the~     procedure. The study seeks to assess for novel genetic variants associated with development~     of AKI after TAVR. Finally the study seeks to assess for novel genetic variants and~     biomarkers that are associated with adverse cardiovascular events after TAVR and to further~     explore how these events may inter-relate with acute kidney injury.~   "
59208|NCT02791867|"~     The primary objective is to determine if subjects taking the natural product AphoelineBrake™~     in addition to their standard treatment experience differences in metabolic disease control,~     gastrointestinal hormones and inflammatory markers diet, hunger, satiety, weight, compared to~     patients taking a placebo in addition to their standard treatment. The secondary objective is~     to study the effect of Aphoeline Brake on oxidative and inflammatory stress markers.~   "
59209|NCT02791854|"~     Innovative programs exist that suggest that care for people with chronic conditions is~     optimized when patients and providers have the information they need at the point of care and~     over time, to engage in shared planning and execution of treatment goals and care plans. This~     project aims to build an Inflammatory Bowel Disease Learning Health System, a shared~     information environment, that highlights collaboration among patients, clinicians and care~     team members, and researchers; for effective use of data for guiding care, value,~     improvement, and research.~   "
59210|NCT02791841|"~     The purpose of the present study is to compare the effectiveness of Rhythmic Reading Training~     (RRT), a computer-assisted intervention method that combines sublexical reading exercises~     with rhythm processing, and that of an intervention resulting from the combination of two yet~     validated treatments for DD, namely, Bakker's Visual Hemisphere-Specific Stimulation (VHSS)~     and the Action Video Game Training (AVG). Finally, the effectiveness of the administration of~     only AVG is intended to be compared to other treatments. All interventions are administered~     for 13 hours over 9 days to a group of Italian students with DD aged 8-12.~   "
59211|NCT02791828|"~     Chronic Hemodialysis is a treatment for kidney failure. It involves the construction of three~     treatment sessions per week extrarenal lasting 4 hours each. This treatment is necessary but~     it has an impact on the quality of life of patients.The investigators believe that to improve~     the overall quality of life in hemodialysis patients, the quality of each hemodialysis~     session must be improved. The quality criterion is not only medical, it must also take into~     account the patient's perception about the course of its meeting : that's what we call~     quality of experience of the dialysis session. Our daily healthcare practice shows that each~     hemodialysis session is experienced differently by the patient according to different factors~     : physical, psychological, relational, technical, temporal. The quality of the experience of~     a hemodialysis session could be positively influenced by the use of supplements occupational~     assets or liabilities, for improving patient satisfaction or by enhancing its relationship~     with the staff. Indeed, a preliminary study ( in the nephrology unit of our establishment in~     January 2012) of 8 patients undergoing active occupational educational activity during~     hemodialysis, showed that the experience of the hemodialysis session was potentially~     improvable (experienced patients improved, reduced cramps ... ). However, to assess the~     impact of such measures on the lives of the dialysis session and the quality of life in~     general, the investigators need to measure the quality of living of a dialysis session. There~     is not, at present, specific tool to measure the quality of the experience of a hemodialysis~     session. This tool would measure the impact of a caregiver support occupational during~     dialysis sessions. The main objective of this study is to create and validate an instrument~     to measure the quality of living of a hemodialysis of chronic renal insufficiency subject.~   "
59212|NCT02791815|"~     The primary purpose of this study is to evaluate the effect of repeated doses of selexipag on~     the pharmacokinetics of a single oral dose of midazolam (i.e., how long and how much~     midazolam is present in the blood)~   "
59213|NCT02791802|"~     This multicenter multinational prospective two-arm matched-pair observational study aims to~     establish a prospective comparison of active lipoprotein apheresis treatment approved and~     conducted according to German guidelines for the indication of elevated Lp(a) versus a~     maximum tolerated lipid-lowering therapy as standard care. Due to the prospective character~     and the inclusion of a control arm, this will be the first clinical study that can confirm~     the relevance of the established approach to use lipoprotein apheresis in those subjects and~     its effects to reduce the individual cardiovascular risk. The optimized management of~     subjects in the control group (not receiving lipoprotein apheresis) will also help to clarify~     the controversial issue, to which extent intensive medical care per se can influence the~     occurence of subsequent cardiovascular events. Primary objective of the trial is to evaluate~     the clinical benefit of Lp(a) reduction using lipoprotein apheresis on myocardial infarction,~     PCI, CABG and death from cardiovascular disease. The primary objective of this study~     evaluates the clinical benefit of weekly lipoprotein apheresis in subjects with progressive~     cardiovascular disease, as accepted by the German Federal Joint Committee as indication for~     subjects with elevated Lp(a). Comparator will be matched subjects under maximum tolerated~     lipid lowering therapy without access to lipoprotein apheresis treatment. The clinical~     benefit will be defined as the reduction of the composite endpoint of major adverse~     cardiovascular events (MACE), defined as either myocardial infarction, PCI, CABG or death~     from cardiovascular disease over a period of at least 2 years after completion of visit 1b~     and until at least 60 events of the primary end-point occurred in group B. If the number of~     at least 60 documented primary endpoint events within 2 years of the completion of enrolment~     did not occur, the study will continue until this number of primary endpoint events has~     accumulated.~   "
59214|NCT02791789|"~     Use of the software could allow learning of reading code in subjects with ASD through the~     design of serious games for educational and therapeutic purposes.~      This SEMATIC software could improve communication and could be integrated into medical~     management (speech therapy and neuropsychological).~      The benefit of an action research will enable training professionals to autism, cognitive~     characteristics of autism and the use of IT support for this population.~   "
59215|NCT02791776|"~     The problem of choosing the supporting vertebra was the subject of several studies. They do~     not suggest as regards the techniques that are not currently used or with insufficient~     setback.~      The need to have a sufficient number of files with a minimum decline of 5 years for proposing~     a multicenter study that will be conducted within the framework of the Scoliosis Research~     Group (SRG) and will result in a roundtable at the next congress GES in March 2015. the GES~     gathers most of the teams that support this pathology.~   "
59216|NCT02791763|"~     This is a Phase III, open-label, active-controlled, parallel-group, multi-center study to~     compare the efficacy and safety of GSK1278863 administered for 52 weeks versus epoetin beta~     pegol in approximately 286 Japanese ND and 50 PD subjects with renal anemia. The study will~     consist of three cohorts. Cohort 1 and Cohort 3 will consist of ND subjects~     (Erythropoiesis-Stimulating Agent [ESA] users and ESA non-users) randomized to receive~     GSK1278863 or epoetin beta pegol in a ratio of 1:1. PD subjects will be enrolled into Cohort~     2 and will receive GSK1278863. This study consists of a 4-week screening phase, a 52-week~     treatment phase (including primary efficacy evaluation period [Weeks 40 to 52]), and a 4-week~     follow-up phase following the treatment phase. The primary objective of this study is to~     demonstrate non-inferiority of GSK1278863 to epoetin beta pegol based on mean hemoglobin~     (Hgb) during the primary efficacy evaluation period in ND subjects. ESA non-users from Cohort~     1 will be excluded from the primary efficacy analysis. Study results will be used as pivotal~     study data for an NDA submitted for GSK1278863 for the treatment of renal anemia in Japan.~   "
59217|NCT02791750|"~     Non-persistence to adjuvant hormonal therapy for breast cancer at 5 years decrease its~     efficacy. The objective of this study is to know the women experience (persistence, treatment~     changes, quality of life) and its determinants, in a french population.~   "
59218|NCT02791737|"~     This pilot trial studies a structured exercise program intervention in improving physical~     activity in older patients with hematologic malignancies undergoing cancer therapy. Patients~     with hematologic malignancies are at an increased risk of functional dependence and injury.~     Structured exercise programs, such as the Otago exercise programme (OEP), may improve~     balance, strength, and prevent fall-related injury in older patients with hematologic~     malignancies undergoing cancer therapy.~   "
59256|NCT02791243|"~     This study evaluates the potential for induction of photosensitization by P-3074 0.25%~     finasteride cutaneous solution compared to that of placebo vehicle cutaneous solution and a~     negative control (0.9% sodium chloride, NaCl)~   "
59219|NCT02791724|"~     The trial aims to evaluate the effectiveness of a novel internet intervention (Desiconnect),~     which was designed to introduce relevant cognitive-behavioral therapy (CBT) techniques to~     Persons with Epilepsy (PwE) and comorbid depression. Therefore, 200 PwE and a current~     depressive disorder (major depressive disorder or dysthymic disorder) will be recruited and~     randomized to two groups: (1) a control group, in which they may engage with any epilepsy~     treatment (Care-as-Usual, CAU) and receive access to Desiconnect after a delay of three~     months (i.e., CAU/wait list control group), or (2) to a treatment group that immediately~     receives six-month access to Desiconnect and may also use CAU. The primary outcome measure is~     the depression scale of the Patient Health Questionnaire (PHQ-9), collected at three months~     post-baseline.~   "
59220|NCT02791711|"~     The aim of this study is to evaluate the use of nasal broadband glasses HFNC (High Flow Nasal~     Cannula) in the initial management of severe bronchiolitis in infants admitted in ICU.~      Nasal HFNC can deliver warmed humidified gas through a nasal interface, greatly improving the~     safety and efficacy of administering O2. This device generates a continuous positive pressure~     in the airways, to reduce the work of breathing. The sealing absence of the HFNC at the nasal~     interface improves patient comfort and avoiding nasal trauma.~   "
59221|NCT02791698|"~     The investigators will conduct a prospective study, in which they will determine sensitivity,~     specificity and diagnostic accuracy of late evening urinary free cortisol~     concentration/creatinine and hair cortisol in differentiating Cushing's syndrome from~     Pseudo-Cushing's syndrome.~   "
59222|NCT02791685|"~     The goal of this study is to determine if a remote cardiac or pulmonary rehabilitation~     program delivered via a smartphone application and regular telephone calls will lead to~     improved patient outcomes as measured by functional capacity, improved patient compliance in~     monitoring symptoms and medication adherence, improved self-efficacy and knowledge in~     managing disease and, a decreased rate of hospitalization and re-admissions.~   "
59223|NCT02791672|"~     The pedicled latissimus dorsi flap is a piece of tissue taken from the back that is used to~     reconstruct the breast after cancerous tissue is removed. Over the years, improvements in~     surgical technique and pain control have decreased the length of stay in hospital after this~     procedure. Recently, early discharge after breast reconstruction using another very similar~     pedicled flap, called the transverse rectus abdominis flap, was shown to be safe,~     patient-centered, and associated with significant hospital cost-savings by another Canadian~     group.~      With increasing pressure from hospital administrators to weigh financial considerations into~     treatment decision making, doctors must test cost-saving strategies in order to ensure~     patient satisfaction and safety. Here, we plan to evaluate patient safety, satisfaction and~     cost efficacy in breast reconstruction using the pedicled latissimus dorsi myocutaneous flap.~      We hypothesize that patient care planning can allow for safe and cost-effective same-day~     discharge and improved patient satisfaction after autologous breast reconstruction using the~     pedicled latissimus dorsi flap. After nearly 10 successful same-day discharges using this~     flap, our experience at the Ottawa Hospital suggests that this practice is safe, has~     increased patient satisfaction scores, decreased narcotic use, no short or long term~     complications and is more cost effective compared to patients who stay overnight.~      In the present study, we hope to quantify our results by demonstrating that same day~     discharge is a cost effective strategy that does not compromise patient safety and~     satisfaction.~   "
59224|NCT02791659|"~     X-ray beam produced during endoscopic retrograde cholangiopancreatography (ERCP) affect not~     only the patient, but the personnel of ERCP team may have the effect from the scattered ray.~     According to the automatic beam adjustment function, the thicker object (eg. lying left~     lateral) might produce higher scatter ray than thinner object (eg. lying prone). The~     investigators evaluate the radiation exposure among ERCP personnel compare between patient's~     2 different positions.~   "
59225|NCT02791646|"~     This trial is a sequential multiple assignment randomized trial (SMART), that will examine~     response to differing doses of a behavioral cancer pain intervention (Pain Coping Skills~     Training [PCST]) and subsequent response-based adjustments to doses. Cancer patients with~     pain will initially be randomized to receive either PCST-Full or PCST-Brief. Participants who~     do not report pain reduction to their initially assigned intervention will be re-randomized~     to receive either maintenance or an increased level of intervention. Participants who report~     pain reduction to their initially assigned intervention will be re-randomized to either a~     maintenance dose or no further treatment. Intervention responses will be compared across~     conditions using a standard two-sided, two-sample t-test. Techniques typically used for SMART~     studies will be used to compare intervention dosage sequences across PCTS that adjusts to~     initial dosage based on patient responses. The risk and safety issues in this trial are low~     and limited to those common to a psychosocial intervention (e.g., loss of confidentiality).~   "
59226|NCT02791633|"~     Observational feasibility study using Patient Reported Outcomes (PRO) to assess quality of~     life and 'return to normal life' up to 1 year following emergency laparotomy~   "
59227|NCT02791620|"~     The objective of this study is to evaluate arm rejuvenation and tightening with a~     nanofractional radiofrequency device, Venus viva, Venus concept, Toronto Canada. We recruit~     20 subjects. All 20 subjects are treated with 3 sessions, 1 month interval with a nano~     fractional radiofrequency device on the inner upper arm. We evaluate skin tightening using~     %improvement of treated surface areas and skin elasticity using Dermalab the result at 3~     months after the last treatment and clinical improvements evaluated by two board certified~     dermatologist (using compared photos between before treatment and 3 months after the last~     treatment).~   "
59257|NCT02791230|"~     Phase 3 extension study to evaluate the safety of oral daily dosing of 20 mg or 80 mg~     tafamidis meglumine in subjects with either transthyretin genetic variants or wild-type~     transthyretin resulting in amyloid cardiomyopathy~   "
59270|NCT02791061|"~     The primary aims of this study are to 1. Develop an automated method of quantitation of RV~     remodeling in terms of regional RV surface curvature and area strain and assess the~     feasibility, repeatability and accuracy in normal subjects and patients with repaired TOF,~     patients with PS~      The secondary study aims of this study are to~      1. Compare the differences of RV remodeling in repaired TOF patients, PS patients with sex~     and age-matched controls 2, Assess the relationship of our proposed parameters to global RV~     function and exercise capacity in repaired TOF patients and PS patient~   "
59228|NCT02791607|"~     HNSCC is the 4th highest incidence of cancer and 6th of cancer death of the males in Taiwan.~     Because the patients were mainly middle-aged male, the disease eventually resulted in a huge~     loss of labor force, productivity and a huge burden of family supports and medicinal costs.~     Currently, the primary treatments of HNSCC are mainly surgery, radiotherapy, chemotherapy or~     targeted therapy or concurrent chemoradiotherapy. Compared to oral cavity cancer, patients~     with pharyngeal cancer would possibly harbor HPV infections and have better treatment~     outcomes, prognosis and survival with clinically significance; however, the investigator's~     reports showed quite the opposite prognostic value in oral cavity cancer. The inconsistent~     data urges us to investigate further. Fortunately, in recent years, The investigator have~     developed a new method for isolation and detection of CTCs in HNSCC patients.The~     investigator's data found that high level of CTCs in patients with HNSCC and might be~     associated with disease prognosis, response to treatment and distant metastasis. This novel~     tool enhances the studies addressing on metastases or recurrence process in HNSCC patients.~     However, the investigator did not focus whether if the dynamic change of CTCs and specific~     surface markers on CTCs, such as P16+ CTCs are clinically meaningful.~      Therefore, in the first year, the investigator will utilize the investigator's developing~     device and protocol to isolate high-purity CTCs to further identify P16+ on CTCs. In the~     following 2 years of the project, the investigator will enroll 150 freshly diagnosed patients~     with oral cavity, oropharyngeal, hypopharyngeal and laryngeal cancer at all stages (75 P16+~     and 75 P16- patients) and 30 healthy donors for cell line tests, and then analyze CTCs,~     background white blood cells signals, and their initial biopsied tissue for P16 positivity~     test. Further statistical tests with clinical conditions (disease status, treatment effects,~     progression or distant metastasis and death) will be performed to elucidate their clinical~     significance.Hopefully, the investigator will clarify the clinical significance of~     circulating P16 expression status on CTCs by this study and provide a new biomarker for~     clinical cancer care.~   "
59229|NCT02791594|"~     Up to 35 adult patients with metastatic melanoma will be enrolled in this study with a target~     enrollment of 30 evaluable subjects who complete the baseline and an approximately 3 week FDG~     PET/CT scans, they may also complete an FDG PET/CT after 10 weeks of pembrolizumab therapy.~     Subjects may also be a part of the Penn Melanoma Tissue Collection Program and then will be~     asked to have one additional tumor biopsy and one additional blood draw for the purposes of~     this imaging study. Subjects who are eligible for this imaging protocol will undergo a~     baseline FDG PET/CT scan as part of their clinical restaging prior to starting new therapy. A~     research FDG PET/CT will take place approximately 3 weeks post-therapy and a 3rd FDG PET/CT~     scan will be done at more than 10 weeks after starting pembrolizumab, this scan may be done~     as a clinical scan for evaluation of response or restaging after therapy, however, if it is~     not ordered as a clinical scan it will be done as a research scan. Changes in FDG uptake will~     be correlated with blood and tissue results from the patient's medical records and from the~     data collected as part of the Penn Melanoma Tissue Collection Program and with long term~     outcomes including progression free and overall survival.~   "
59230|NCT02791581|"~     This study is being done to see if patients receiving chemotherapy for breast cancer affects~     the heart, the ability to exercise and fatigue when compared to patients who do not have~     cancer.~   "
59231|NCT02791568|"~     The purpose of the study is to develop advanced ultrasound (U/S) and Magnetic Resonance~     Imaging, known as MRI to study uteroplacental health. The goal of this study is to evaluate~     the blood and oxygen flow to the placenta using advanced U/S and MRI testing.~   "
59232|NCT02791555|"~     The investigators are evaluating the effect of Pradaxa in comparison to warfarin on bone~     turnover and bone density in men and women with atrial fibrillation.~   "
59233|NCT02791542|"~     This will be a single site, mechanistic study of asthmatic subjects and healthy,~     non-asthmatic controls involving a baseline characterization visit and a research~     bronchoscopy visit. We will identify differences in airway epithelial epigenetic enhancer~     signatures in asthma, by analyzing freshly isolated airway epithelial cells from healthy~     controls and from well-characterized subjects with asthma.~   "
59234|NCT02791529|"~     The use of electrocautery for surgical skin incision in general surgery is known to decrease~     post-operative pain. This study compares the use of scalpel and electrocautery for surgical~     skin incision in open carpal tunnel release (OCTR).~   "
59235|NCT02791516|"~     A multicenter, randomized, double-blind, placebo-controlled study to evaluate the effect of 6~     months treatment with Romosozumab compared to placebo by determining the percent changes in~     bone mineral density~   "
59236|NCT02791503|"~     Irreversible electroporation (IRE) is a promising new ablation technique to fight pancreatic~     cancer. The primary aim of the CROSSFIRE trial is to compare the efficacy (in terms of~     overall survival) of FOLFIRINOX and IRE (experimental arm) to the efficacy of FOLFIRINOX and~     stereotactic ablative radiotherapy (SABR) (control arm) in patients with locally advanced,~     non-resectable, non-metastasized, pancreatic cancer (LAPC). Secondary outcomes are~     progression free survival, safety/toxicity, immunomodulation, tumor marker Cancer Antigen~     (CA) 19.9, quality of life (QoL), and total direct and indirect costs for each treatment arm~     (cost-effectiveness analysis).~   "
59237|NCT02791490|"~     This trial is designed to evaluate, in adult participants with Type 2 diabetes mellitus~     (T2DM) and inadequate glycemic control on sub-maximal metformin mono-therapy (1000 mg/day),~     the effect of up-titration of metformin plus the addition of sitagliptin compared to~     up-titration of metformin alone on glycemic control. The primary hypotheses of this study are~     that up-titration of metformin to 2000 mg/day (1000 mg, twice daily [b.i.d]) plus the~     addition of sitagliptin 100 mg/day provides greater reduction in hemoglobin A1C (A1C)~     compared to metformin up-titration alone and that this treatment is safe and well-tolerated.~   "
59238|NCT02791477|"~     Functional results with Attune Fixed Bearing Posterior Stabilized total knee arthroplasty~     evaluated with KOOS. A prospective longitudinal cohort study with repetitive measurements 6~     weeks, 3, 6, 12 and 24 months postoperative.~   "
59239|NCT02791464|"~     The pilot study investigates the potential benefits of the Transcendental Meditation program~     in reducing trauma, including PTSD, in female prisoners. Subjects will be randomly assigned~     to either the TM program or a wait list control group for a period of four months.~   "
59240|NCT02791451|"~     This is an open-label single-center 6-month prospective clinical trial predicting~     exacerbation of COPD with wireless telemonitoring of respiratory rate, heart rate and sleep~     in patients admitted to the pulmonary ward of the Turku University Hospital due to acute~     exacerbation of COPD.~   "
59241|NCT02791438|"~     The purpose of this study is to evaluate the safety of administration of TAK-536 in pediatric~     patients aged 6 to less than 16 years with hypertension.~   "
59269|NCT02791074|"~     This proposed study aim to:~        1. Determine intra-LV pressure-time profile non-invasively using recently developed echo~          Doppler VFM analysis and applanation tonometry and myocardial elastic properties, in HF~          subjects (both HFNEF and HFREF) compared to normal volunteers.~        2. Correlate calculated intra-LV pressure parameters with NT ProBNP levels.~   "
59242|NCT02791425|"~     Objectives:~      Specific Aim 1: To demonstrate the feasibility of using a Steady State Visual Evoked~     Potential (SSVEP) based Brain Computer Interface (BCI) device to facilitate communication of~     common patient needs in alert mechanically ventilated patients in the Intensive Care Unit~     (ICU).~      Specific Aim 2: To determine patient, family and bedside nurse satisfaction with~     communication using the BCI device and elicit open-ended feedback to guide future device~     improvements~      Design:~      Translational pilot study of a Steady State Visual Evoked Potential (SSVEP) based BCI system~     to facilitate communication in intubated patients, with sequential use of the BCI device and~     a picture board.~      Selection of the primary self-identified primary patient need on the BCI device will be~     compared to the icon selected on the picture board (reference standard). A patient~     satisfaction survey will then be provided to the patient or a family member following use for~     2 hours a day for 3 consecutive days.~      Primary outcome: Accurate selection of the illustrative icon on the brain computer interface~     representing the physical or emotional need self-identified by the patient as being the most~     common trigger for communication with the bedside nurse during their admission.~      Secondary outcome: Selection by patients or family of agree or strongly agree with the~     statement The Brain computer interface device allowed me to communicate my needs to the~     bedside nurse adequately.~      Intervention: Use of the brain computer device in the ICU for communication for 2 hours a day~     for 3 consecutive days~      Control/ Comparator: Sequential use of a communication picture board for 2 hours a day for 3~     consecutive days, on the same days that the BCI device is used Sample Size: 30 mechanically~     ventilated but alert patients in the Intensive Care Unit~   "
59243|NCT02791412|"~     The purpose of this study is to evaluate long-term outcome of treatment(percutaneous coronary~     intervention or coronary-artery bypass graft) in unprotected left main coronary artery~     stenosis in Korea.~   "
59244|NCT02791399|"~     This is a randomized controlled trial of a multifaceted intervention designed to improve the~     safety of opioid prescribing. The specific aims of this study are to: (a) evaluate whether a~     multifaceted intervention (Improving the Safety of Opioid Prescribing; ISOP) enhances opioid~     safety, (b) assess whether participation in ISOP impacts the clinician-patient relationship,~     and (c) explore to what extent ISOP is associated with changes in pain and pain-related~     function.~   "
59245|NCT02791386|"~     The purpose of this study is to describe current rescue treatment pattern for nucleot(s)ide~     analogue (NA) resistance and assess the real-world treatment outcomes and health resources~     utilization of rescue treatments for drug resistance in a clinical cohort of Chinese patients~     with chronic hepatitis B (CHB).~   "
59246|NCT02791373|"~     The purpose of this study is to determine whether the efficacy of gemcitabine is comparable~     with the efficacy of the standard chemotherapy with vinorelbine for mobilization of~     autologous stem cells in myeloma patients~   "
59247|NCT02791360|"~     Through this study, the investigators believe to describe more accurately the damage caused~     by brain radiation therapy in the long term.~   "
59248|NCT02791347|"~     Chemotherapy conditioning, preceding Stem Cell Transplantation (SCT), has been associated~     with severe gastrointestinal toxicity, commonly compromising patients' food intake,~     nutritional status and functioning level. Malnutrition has been associated with worse~     functional status, reduced survival, increased rate of infections, complications,~     hospitalizations, and therapy toxicity in oncology patients.~      To date, there is no Randomized Controlled Trials (RCT) assessing the impact of a nutrition~     intervention on SCT patients who remain at risk of malnutrition even 100 days post SCT. The~     proposed study is a single center, prospective, RCT with a parallel design that aims to~     assess the impact of a nutrition intervention on the nutritional and functional statuses of~     SCT recipients 100 days post SCT.~   "
59249|NCT02791334|"~     The main purpose of this study is to evaluate the safety and tolerability of anti-programmed~     cell death ligand 1 (PD-L1) checkpoint antibody LY3300054 in participants with advanced~     refractory solid tumors.~   "
59250|NCT02791321|"~     Frailty is a age dependent physiological state of vulnerability. Frailty is screened by the~     phenotypic model (5 clinical criteria) or the cumulative model (various clinical and~     biological criteria). Currently, aging with autism spectrum disorder and mental retardation~     (ADS-MR) is poor described. Nevertheless many data indicate that people with ADS-MR may~     present an early aging.~      Principal aim of this study is to determine if frailty in people with ADS-MR aged over 20~     years depend on age. Secondary aims are to evaluate frailty prevalence, to describe with~     details health according to age, and to verify the frailty index validity for predicting~     falls, hospitalisation and death, in this population of ADS-MR patients aged over 20 years.~      This monocentric and prospective study will include 60 ADS-MR patients aged over 20 years and~     living in Languedoc-Roussillon's medico-social care homes. Patients are evaluated at the time~     of inclusion. Frailty index is calculated from 104 clinical and biological criteria.~     Furthermore the investigator staff collect data about ADS severity (CARS), adaptative and~     intellectual functionning (Vineland), and psychiatric and somatic comorbidities (Reiss scale,~     DSQIID and CIRS). Falls, hospitalisations or death occurrence is then collected every year~     during 5 years.~      The connection between frailty index and age will be studied using linear regression. The~     frailty index validity will be analysed using ROC curves. Modelisation of the falls,~     hospitalisations or death risk in the 5 years after the initial evaluation will help in~     identification of the more frailty predictive criteria.~   "
59251|NCT02791308|"~     The purpose of this study is to compare the safety and efficacy profiles of Watson~     Laboratories, Inc.'s Pimecrolimus Cream, 1% to those of Valeant Pharmaceuticals North America~     LLC's Elidel® (pimecrolimus) Cream, 1%, and to demonstrate the superior efficacy of the two~     active creams over that of the placebo (Vehicle of test product), in the treatment of mild to~     moderate atopic dermatitis.~   "
59252|NCT02791295|"~     The purpose of the study is to determine whether a personalized lifestyle intervention~     focused on diet and physical activity reinforcement is effective in avoiding weight gain in~     the first months following initiation of subcutaneous insulin pump therapy in type-2 diabetic~     patients.~   "
59253|NCT02791282|"~     Phase III diagnostic trial to demonstrate that functional lung MRI can replace VQ-SPECT in a~     diagnostic strategy for patients with suspected CTEPH where positive findings are verified~     with catheter pulmonary angiography (CPA), or computed tomography pulmonary angiography~     (CTPA)~   "
59254|NCT02791269|"~     This is an expanded access, multicenter, national, open-label, and non-randomized study to~     analyze the safety of peginterferon alfa-2a in participants with hepatitis B e antigen~     (HBeAg) positive and HBeAg negative chronic HBV infection. All participants will receive 48~     weeks treatment of peginterferon alfa-2a monotherapy, followed by a 24 week treatment-free~     follow-up period.~   "
59255|NCT02791256|"~     This multicenter, open-label, uncontrolled study will evaluate the efficacy and safety of~     increasing the dose of peginterferon alfa-2a (Pegasys) in participants with Genotype 1/4/5/6~     CHC and an early non-response to a standard course of peginterferon alfa-2a plus ribavirin.~     The study will consist of screening (4 weeks), treatment (32 weeks), and follow-up (24~     weeks).~   "
59258|NCT02791217|"~     MiRNAs are small (~19-25 nucleotides) non-coding RNA molecules that bind to mRNA in a~     sequence-specific manner. MiRNAs regulate gene expression at the post-transcriptional level.~     MiRNAs regulate critical cell processes such as metabolism, apoptosis, development, cell~     cycle, hematopoietic differentiation and have been implicated in the development and~     progression of several types of cancers, including hematological malignancies.~     Over-expression, amplification and/or deletion of miRNAs and miRNA-mediated modification of~     epigenetic silencing can all lead to oncogenic pathways.~      Hematologic cancers, which are caused by the malignant transformation of bone marrow cells~     and the lymphatic system, are usually divided into three major clusters: leukemia, lymphoma,~     and multiple myeloma. To date, some of the hematological malignancies are very aggressive~     that early diagnosis is essential for improving prognosis and increasing survival rates.~     However, current diagnostic methods have various limitations, such as insufficient~     sensitivity, specificity, it is also time-consuming, costly, and requires a high level of~     expertise, which limits its application in clinical contexts. Thus, development of new~     biomarkers for the early detection and relapse of hematological malignancies is desirable.~      Some of the innate properties of miRNAs make them highly attractive as potential biomarkers.~     MiRNAs can be readily detected in small volume samples using specific and sensitive~     quantitative real-time PCR; they have been isolated from most body fluids, including serum,~     plasma, urine, saliva, tears and semen and are known to circulate in a highly stable,~     cell-free form. They are highly conserved between species, allowing the use of animal models~     of disease for pre-clinical studies. Furthermore, tumor cells have been shown to release~     miRNAs into the circulation and profiles of miRNAs are altered in the plasma and/or serum of~     patients with cancer. A growing number of publications confirm that miRNAs can be a useful~     biomarker for hematological malignancies diagnosis and progression.~   "
59259|NCT02791204|"~     This study will use SPECT/CT imaging to assess the effect of percutaneous revascularization~     treatments in patients with Peripheral arterial disease and diabetes mellitus, in whom the~     disease can progress more quickly than in patients without diabetes.~   "
59260|NCT02791191|"~     The main purpose of this study is to evaluate the safety and the effect on brain tau of the~     study drug LY3202626 in participants with mild Alzheimer's disease (AD) dementia.~   "
59261|NCT02791178|"~     The overall objective of this research proposal is to use OCT to investigate those~     morphological culprit plaque characteristics associated with the risk of developing MVO in~     reperfused STEMI patients.~   "
59262|NCT02791165|"~     There is an optimal day on which to perform the CMR scan which allows one to capture the~     information required to assess the dynamic changes in the reperfused STEMI patient. The main~     objective is to characterise the dynamic changes in LV function, MI size, myocardial edema,~     MVO, IMH, interstitial volume in the remote myocardium over the first 10 days of an acute~     reperfused STEMI in order to identify the optimal day for performing the CMR scan.~   "
59263|NCT02791152|"~     A prospective cohort of relatively healthy individuals, using comprehensive clinical~     information, advanced imaging (including cardiac MRI), cardiovascular exercise physiology,~     metabolomics and genetic analysis. These findings will be correlated with adverse clinical~     outcomes including death, stroke and myocardial infarction. In selected cases, follow-up~     imaging and biomarker samples will also be obtained. These studies will enable us to begin to~     address a critical gap in our knowledge as to how best to interpret the very large amount of~     cardiovascular tests done in Singapore and how to better to predict outcomes and manage~     healthcare costs in our local populations~   "
59264|NCT02791139|"~     The investigators aim to investigate the association of midlife dietary and lifestyle factors~     on cardiac functional changes in the elderly. The investigators hypothesize that even in~     those without clinically manifest cardiovascular disease, the extent of underlying~     abnormalities in cardiovascular structure and function in the elderly would be independently~     related to midlife dietary and lifestyle factors.~   "
59265|NCT02791126|"~     Heart failure is a major health care burden. It can occur with either normal or reduced LV~     ejection fraction, depending on different degrees of ventricular remodelling. The~     investigators recently published a new method, curvedness-based imaging. The investigators~     have also reported the diagnostic utility of curvedness-based imaging in various cardiac~     diseases. The investigators now propose to prospectively assess curvedness-based imaging for~     diagnosis of heart failure with normal ejection fraction and with reduced ejection fraction,~     and examine left ventricular systolic and diastolic function and predicts the prognosis in a~     cohort of HF patients.~   "
59266|NCT02791113|"~     The investigators propose to develop a computational framework involving a novel automatic~     image segmentation algorithm based on CTA images, an artery model reconstruction algorithm~     for stenosis detection, and quantification of severity of stenosis in terms of area stenosis.~   "
59267|NCT02791100|"~     Young children in Ethiopia lack sufficient protein and micronutrients for growth and~     development. The overall purpose is to assess the effects of promoting egg and eggshell~     powder consumption on improving the nutritional status of children 6 to 15 months in Halaba~     Special Woreda, Southern Ethiopia. The hypothesis is that providing chickens to produce eggs~     (egg and eggshell) for young children will improve growth in otherwise malnourished young~     children. Upon providing chickens, the nutritional status of young children prior and after~     the intervention (by 6 months) will be assessed. Identification of the knowledge, attitude~     and practices (KAP) of mothers on egg and eggshell powder consumption by their children~     before and after the intervention in the intervention group will be done. Caregivers will be~     instructed to give each child 1 egg (cooked) and 1/4 bottle cap of eggshell (500 mg~     calcium) per day in the intervention. Hemoglobin will be measured as an indicator of overall~     nutritional status. Throughout the study, any problems arising in keeping chickens will be~     recorded in order to assess the feasibility and practicality of raising chickens as way to~     improve nutritional status of young children. The study is novel in that investigators are~     providing a way to have increased protein, increased micronutrients, and use of eggshell as a~     source of calcium.~   "
59268|NCT02791087|"~     CFD simulations in this study provide detailed hemodynamics information, which cannot be~     obtained from cardiac images alone. The investigators hypothesize that our proposed~     simulations will provide strong correlation between hemodynamic parameters, such as WSSG and~     SPA, and clinically identified graft stenosis. These correlations will allow the~     investigators to identify the future patients at high risk of graft stenosis and lead to~     future researches on optimizing and refining surgical plans, such as finding optimal proximal~     and distal anastomoses locations, optimal graft length and diameter, which could lead to~     improved longevity of the graft. Once CFD coupled shape optimizer is validated, it could be~     part of the surgical simulator to help in training the next generation physicians. It could~     provide new viewpoints for assessing whether some modified surgical techniques are better or~     not. It could also aid in designing and evaluating the vascular medical devices, including~     stent, artificial graft, and etc., which would lead to better surgical outcome.~   "
59273|NCT02791022|"~     Atrial fibrillation is a common disease in the aging population that has severe implication~     if left untreated as it leads to embolic stroke and other embolic phenomenon. Embolic stroke~     in particular has severe implications to our community as the cost of care for such immobile~     patients can be extremely high. Atrial fibrillation typically begins as Paroxysmal atrial~     fibrillation (PAF), which makes early detection extremely difficult as the PAF may only occur~     transiently in the initial stages. Long term continuous ECG monitoring is currently required~     over weeks to detect early PAF. Current devices typically need to be implanted (loop~     recorders) to be sensitive enough to detect infrequent episodes of PAF. New generation ECG~     remote devices (non-invasive) are however now available that are wearable over long periods~     and can send data directly to a database for centralized collection and analysis of the data.~     The aim of this study will be to use such a device to evaluate the incidence of PAF in~     different population of patients, with each patient wearing and sending continuous ECG data~     for periods of a week or more to a central database, across several public hospitals in~     Singapore.~   "
59274|NCT02791009|"~     To build on Singapore's competitive advantages in advanced cardiac imaging, genetic and~     molecular studies to develop an integrated one -stop platform spanning from human to large~     and small animal models, dedicated to deepening the understanding of CV disease progression,~     discovery of new targets and repurposing of drugs.~   "
59275|NCT02790996|"~     The study aims to compare the efficacy, safety and pharmacokinetics (PK) of an optimised~     dosing to a standard dosing regimen of vancomycin in neonates and infants aged ≤ 90 days with~     late onset bacterial sepsis known or suspected to be caused by Gram-positive microorganisms~   "
59276|NCT02790983|"~     Clinical, diagnostic, and therapeutic data specific for primary spinal column tumor patients~     will be collected and evaluated to investigate the prognostic factors which influence~     survival, local recurrence, adverse events, perioperative morbidity, and HRQOL in subgroups~     of patients diagnosed with primary spinal column tumors.~   "
59277|NCT02790970|"~     Depression is a very common, serious and in some cases life‐threatening condition, affecting~     around 350 million people globally. Approximately 11% of citizens in the European Union~     suffer from depression at some point in their lives. Depression is associated with~     significant socio-economic costs and has been predicted to become the greatest cause of~     disability worldwide by 2030 . In 2010 it was estimated that there were approximately 30~     million patients with depression in Europe, with aggregated economic costs of approximately~     €92 billion . Improvements in managing the treatment of depression are urgently needed to~     improve patient outcomes, contain rising healthcare costs, improve workplace productivity and~     help to address global economic and societal challenges.~      While a range of effective antidepressant medications are available to treat depression, it~     takes 4-6 weeks after starting antidepressant treatment before a physician can detect whether~     the treatment is working. However, surprisingly, more than 50% of patients fail to respond to~     the first antidepressant treatment they are prescribed. Therefore, it often takes several~     months to identify an effective antidepressant treatment for the majority of patients with~     depression. During this time a patient's ability to work and function socially is severely~     impaired. Individuals may be absent from work for many weeks or months and this places a~     substantial burden on the economy and on healthcare resources.~   "
59278|NCT02790957|"~     Chronic non-healing wounds represent a major source of morbidity, disability, and mortality~     in diabetic patients. Diabetes is the leading cause of non-traumatic limb amputations~     worldwide. Many patients with ischemic or neuroischemic wounds are not candidate to~     surgical/endovascular revascularization, owing to anatomical vascular reasons or for the~     underlying conditions and co-morbidities. Therefore, identification of novel medical~     treatment strategies to improve wound healing in diabetic patients is a major challenge for~     clinicians, researchers, and health care systems.~      Defects in bone marrow (BM)-derive stem and progenitor cells, including EPCs (endothelial~     progenitor cells), contribute to diabetic complications. Stem cell mobilizing agents have~     been previously studied as an adjunctive therapy for critical limb ischemia and chronic~     non-healing wounds in diabetic and non-diabetic patients, as well as for the treatment of~     diabetic wound infections . Meta-analyses of such studies indicate that stem cell~     mobilization in these clinical conditions is safe and potentially effective in improving~     surrogate outcome measures and hard endpoints (such as rates of wound healing and~     amputation).~      This study plans to evaluate whether a single injection of Plerixafor improves wound healing~     in diabetic patients with stage III-IV (neuro)ischemic wounds.~   "
59279|NCT02790944|"~     The primary objective of the study will be to estimate the prevalence of germline mutations~     in patients who present consecutively within 12 weeks of a confirmed diagnosis of pancreatic~     ductal adenocarcinoma.~   "
59280|NCT02790931|"~     The main objective of this trial is to investigate the effects of foot muscle strengthening~     in daily activity of patients with diabetic neuropathy.~   "
59281|NCT02790918|"~     In this study, study team aim to i) evaluate the accuracy of 3D IVS curvedness for prediction~     of RV systolic pressure (RVSP), mean pulmonary artery pressure (mPAP) and pulmonary vascular~     resistance (PVR) with RHC; ii) evaluate the usefulness of 3D IVS curvedness for predicting~     the response to vasodilator challenge with RHC, in patients clinically suspected or known to~     have primary PH.~   "
59282|NCT02790905|"~     The objective of this study is to validate the Patient Health Questionnaire-9 (PHQ-9) and the~     Refugee Health Screener-15 (RHS-15) screening tools for depression in pregnant and~     post-partum migrant women on the Thai-Myanmar border.~   "
59283|NCT02790892|"~     The Creative Arts Diabetes Initiative will offer facilitated art therapy with a~     group/peer-support environment to two groups of youth/young adults, one with type 1 diabetes,~     and one with type 2 diabetes. This environment intends to meet youth where they are,~     promote universality, hope and self-understanding, has the potential to be therapeutic and~     allows youth to express and learn about themselves and each other while developing healthy~     coping skills and address their fears and concerns.~   "
59301|NCT02790658|"~     Investigate the bioavailability of the main flavonoid, their colonic transformation and~     untargeted metabolites by an metabolomic approach following acute intake of a grumixama juice~     by humans.~   "
60369|NCT02776670|"~     The purpose of this study is to evaluate the clinical effectiveness of SYSTANE® BALANCE~     compared to REFRESH OPTIVE® Advanced in subjects with lipid-deficient dry eye.~   "
59284|NCT02790879|"~     The main objective of register-SAFETIM is to assess the impact of the transition from~     pediatric to adult cystic fibrosis care center on changes in lung function and nutritional~     status of patients.~      This is a multicenter, observational, longitudinal, with analysis of the French national~     registry data of patients with cystic fibrosis.~      Our study will assess the clinical features of adolescent patients with cystic fibrosis~     during the transition from pediatric care to adult care. It will explore factors associated~     with the impact of the transition on the clinical course of adolescent patients (respiratory~     and nutritional functions).~   "
59285|NCT02790866|"~     This study evaluates the feasibility and acceptability of LuCaS Choices, a web-based decision~     aid designed to facilitate informed decision making about participation in lung cancer~     screening among individuals at high risk of lung cancer due to heavy cigarette smoking.~   "
59286|NCT02790853|"~     The goal of this clinical research study is to learn if new types of imaging devices can help~     doctors decide if a lesion in the mouth is pre-cancerous or cancerous.~      This is an investigational study. The HRME and PS2.1/PS3 imaging devices are not FDA approved~     or commercially available. Their use in this study is considered investigational. Proflavine~     hemisulfate is FDA approved and commercially available for treating umbilical cord stumps of~     newborn babies. Proflavine hemisulfate is not FDA approved or commercially available to use~     as a dye in the mouth. Its use in this study is considered investigational.~      The study doctor can explain to you how the imaging devices are designed to work.~      Up to 600 participants will be enrolled in this study. All will take part at MD Anderson.~   "
59287|NCT02790840|"~     The purpose of this study is to compare the multiple dose pharmacokinetics (PK) of three~     gefapixant (AF-219) formulations; to assess the effect of Omeprazole on the multiple dose PK~     of three gefapixant formulations; and, to assess the safety and tolerability of gefapixant.~   "
59288|NCT02790827|"~     This study evaluates the effectiveness of a multi-pronged intervention in reducing and~     preventing violence against women and children compared to a treatment as usual control group~     among families living in Lusaka, Zambia.~   "
59289|NCT02790814|"~     Annually, an estimated 2.6 million still births occur half of which die during labor and~     delivery (fresh stillbirths). In addition, around 750,000 newborns die shortly after birth~     due to intrapartum-related hypoxia or birth asphyxia. Almost 99% of these perinatal deaths~     take place in low-income countries where the provider/patient ratio is low and fetal~     monitoring is inadequate. Poor intrapartum fetal heart rate monitoring, failure to identify~     fetal distress, and subsequently intervene, is a common pathway to perinatal deaths in these~     low-resourced settings. Recently, an innovative fetal heart rate monitoring device, called~     Moyo, using ultrasound technology, was developed to be strapped on the mother during labour.~     This project will compare the effectiveness of automatic use of Moyo versus intermittent use~     of hand-held fetoscope in detection of abnormal fetal heart rate, through a randomized~     control study, at Haydom Hospital, Tanzania.~   "
59290|NCT02790801|"~     The purpose of this study is to evaluate the management of chronic heart failure patients~     with atrial fibrillation, to collect data on compliance with clinical guidelines and the~     prevalence of long-term anticoagulant therapy,complications. The results will be used to~     develop most rational therapeutic and diagnostic strategies to improve clinical outcomes of~     such patients.~   "
59291|NCT02790788|"~     Early stress-dose steroids are of uncertain efficacy in cardiac arrest. The current authors~     plan to conduct a prospective, randomized, placebo controlled evaluation of stress-dose~     steroids efficacy with repect to early postresuscitation hemodynamics, heart function, brain~     perfusion, and inflammatory response in vasopressor-requiring cardiac arrest. Patients will~     also be followed for organ dysfunction, potential, steroid-associated complications, and~     functional outcome at hospital discharge.~   "
59292|NCT02790775|"~     In this double blind clinical trial, 1000 patients suffering from diabetic macular edema,~     age-related macular degeneration, neovascularization due to proliferative diabetic~     retinopathy and cystoid macular edema secondary to retinal vascular occlusions are included.~     Those with the history of Ocular pain prior to the procedure, any contraindication for~     Intravitreal Bevacizumab Injection (IVI), history of any kind of anterior segment conditions~     that could affect pain sensation, history of using systemic analgesic or sedative~     medications, history of previous eye surgery other than for cataract, glaucoma, uveitis and~     bullous keratopathy and poor cooperation in using the visual analogue scale (VAS) are~     excluded from the study. Before starting the treatment all patients undergo complete~     ophthalmic exam , best-corrected visual acuity (BCVA) checking and macular thickness~     measurements using optical coherence tomography (OCT). Patients are randomly assigned to each~     group .Each participant receive one injection in one eye in this study. Pain is measured by~     subjective grading on a Visual Analog Scale (VAS) immediately after IVI. BCVA and OCT would~     be checked again at month one.~   "
59293|NCT02790762|"~     The purpose of this study is to evaluate the safety and efficacy of human umbilical cord~     mesenchymal stem cell(hUC-MSC) for Pneumoconiosis.~   "
59294|NCT02790749|"~     Although evidence is amassing regarding the role of intra-articular pathology in the surgical~     management of adolescents and adults with hip dysplasia, the optimal method of detection and~     especially management of this pathology remains unclear. No studies exist to compare clinical~     outcomes and hip survival between arthroscopy and arthrotomy in patients with mechanical hip~     pain undergoing periacetabular osteotomy (PAO) for dysplasia, and this is what the~     investigators aim to achieve in the current prospective randomized surgical trial.~   "
59295|NCT02790736|"~     The study will test the efficacy of propranolol or placebo, administered after retrieval of a~     previously acquired public speaking fear, in reducing fear and avoidance of public speaking.~   "
59296|NCT02790723|"~     This study seeks to determine the safety of three different doses of sc-rAAV2.5IL-1Ra~     delivered by intra-articular injection into one knee joint of patients with moderate OA of~     the knee.~   "
59297|NCT02790710|"~     The study will test the efficacy of propranolol or placebo, administered after reactivation~     of a previously acquired obsessive-compulsive disorder (OCD) fear, in reducing fear and~     avoidance in OCD.~   "
59339|NCT02790151|"~     Memory deficits after brain damage are common and there is still a need for evaluated therapy~     methods. In this study we compare two therapeutic interventions and investigate whether~     therapy effects can be found on neuropsychological tests and on a test measuring memory in~     everyday life.~   "
59302|NCT02790645|"~     Diabetes mellitus is a chronic disease of high socio-health relevance for their clinical and~     economic implications (risk of complications, disability ...) (healthcare costs). Strict~     glycemic control and intensive treatment and support have shown long-term patient with type 1~     diabetes mellitus (DM1) improved health. The intensive insulin therapy involves the~     administration of insulin through 3 or more injections per day (MDI), or through a continuous~     subcutaneous insulin infusion (CSII). New technologies applied to the treatment of DM1, such~     as telemedicine, could bring benefits to patients. The available scientific evidence to date~     shows that telemedicine systems have beneficial or neutral effects on glycemic control,~     expressed in terms of HbA1c in patients with type 1 diabetes treated with MDI or CSII. They~     have also shown not to worsen the quality of life and reduce the costs associated with the~     care of these subjects. However, studies published to date are generally short follow-up,~     small sample size, and have not evaluated other biological parameters such as glycemic~     variability, inflammatory markers and markers of oxidative stress as well as a psychological~     assessment including depression, anxiety, Diabetes-related distress and fear of hypoglycemia.~     It has been designed a randomized crossover 18 months in order to study the effect of a~     telemedicine program in a group of subjects with DM1 in CSII on clinical variables of~     metabolic control variables, including parameters of glycemic variability, markers of~     inflammation and oxidative stress, psychological variables and quality of life, and~     associated costs.~   "
59303|NCT02790632|"~     This study compares EG-1962 to enteral nimodipine in the treatment of aneurysmal subarachnoid~     hemorrhage.~   "
59304|NCT02790619|"~     The purpose of this study is to determine if a new technology applied while listening to a~     mindfulness meditation tape can affect one's ability to achieve a state of mindfulness. The~     new technology is called transcranial direct current stimulation, or tDCS.~   "
59305|NCT02790593|"~     Venous ulceration is a major burden on the NHS. Current treatment involves bandaging therapy~     which is replaced on a once or twice weekly basis. The Juxta-CuresTM device offers an~     alternative solution for the long-term treatment of patients with venous ulceration. This is~     a removable adjustable device with an inbuilt pressure monitor. The aim of this study is to~     determine whether the Juxta-Cures™ device provides at least equivalent ulcer healing for~     patients with venous ulceration compared to bandaging. Secondary outcome measures include~     whether the Juxta-Cures™ device improves patient compliance and quality of life compared to~     bandaging, and whether the Juxta-Cures™ device is cost effective compared to bandaging.~   "
59306|NCT02790580|"~     Background: The investigators previously studied the addition of low-dose, short-course~     sunitinib to pre-operative chemotherapy in the neoadjuvant setting in newly diagnosed breast~     cancer patients with measurable primary breast tumor in a phase Ib/II study at the National~     University Cancer Institute, Singapore. These data showed that the addition of sunitinib~     improved tumor vascularization as hypothesized with enhanced short-term treatment response.~     However, pathological complete response rate after 4 cycles of chemotherapy was not superior~     to standard chemotherapy, and may be attributed to dose delays from increased~     myelosuppression with the addition of sunitinib. The investigators hypothesize that this~     promising regimen may be further optimized with the use of growth factor support. The~     investigators thus plan to study the addition of low-dose, shortcourse sunitinib to~     dose-dense doxorubicin/cyclophosphamide (ddAC) administered every 14 days, supported by~     pegfilgrastim.~      Aim: To confirm that the addition of 12.5mg sunitinib for 5-7 days can be added before each~     cycle of ddAC (delivered every 14 days, supported by pegfilgrastim) without compromising dose~     intensity, in phase II open label single arm part of the study, followed by a phase II~     randomized study to compare the pathological complete response rate of ddAC versus sunitinib~     + ddAC in stage I-III HER2 negative breast cancer patients in the neoadjuvant setting.~      Methods:A single-centre study comprising two phases: a. Phase II open label single-arm study~     that will enroll newly diagnosed stage I-IV HER2 negative breast cancer patients receiving~     either neoadjuvant chemotherapy (stage I-III patients) or first-line palliative chemotherapy~     (stage IV patients). All patients will be treated with 4 cycles of ddAC at standard doses~     (60/600mg/m2) every 2 weeks, supported by subcutaneous pegfilgrastim 6mg, to be administered~     24-36 hours after each dose of chemotherapy. Low dose sunitinib at 12.5mg daily orally will~     be administered for 7 days prior to cycle 1 ddAC, and for 5 days prior to each subsequent~     cycle of ddAC. b. Phase II randomized study that will enroll newly diagnosed stage I-III HER2~     negative breast cancer patients receiving neoadjuvant chemotherapy before definitive breast~     cancer surgery. Eligible patients will be randomized 1:1 to 4 cycles of ddAC with or without~     intermittent sunitinib in patients with measurable primary breast cancer who are receiving~     preoperative chemotherapy.~   "
59307|NCT02790567|"~     The early diagnosis of heparin-induced thrombocytopenia is particularly difficult in surgical~     critically ill patients. If the use of rapid immunological diagnostic methods and pretest~     scoring systems has been proposed in the medical intensive care unit (ICU), none of these~     methods have been specifically evaluated in the diagnosis of HIT in surgical patients.~   "
59308|NCT02790554|"~     Annually, an estimated 2.6 million still births occur half of which die during labor and~     delivery (fresh stillbirths). In addition, around 750,000 newborns die shortly after birth~     due to intrapartum-related hypoxia or birth asphyxia. Almost 99% of these perinatal deaths~     take place in low-income countries where the provider/patient ratio is low and fetal~     monitoring is inadequate. Poor intrapartum fetal heart rate monitoring, failure to identify~     fetal distress, and subsequently intervene, is a common pathway to perinatal deaths in these~     low-resourced settings. Recently, an innovative fetal heart rate monitoring device, called~     Moyo, using ultrasound technology, was developed to be strapped on the mother during labour.~     This project will compare the effectiveness of automatic use of Moyo versus intermittent use~     of hand-held Doppler in detection of abnormal fetal heart rate, through a randomized control~     study, at the University hospital, Dar es Salaam, Tanzania.~   "
59309|NCT02790541|"~     Recent studies show preliminary evidence of HBOT therapeutic effects on angiogenesis,~     increased tissue blood flow and oxygenation correlated with tissue function.~      Our primary hypothesis is that HBOT will have beneficial effects on the above mentioned~     organs associated with aging-related malfunctions due to restored mitochondrial function,~     mobilization of stem cells and induction of angiogenesis.~   "
59310|NCT02790528|"~     The purpose of this study is to evaluate whether statin is effective in the treatment of~     vasospastic angina.~   "
59320|NCT02790398|"~     The aim of this study is to assess the differential effect of two transdiagnostic treatment~     protocols for emotional disorders (ED) (depression and anxiety disorders) using a randomized~     pilot study design: a) a transdiagnostic treatment protocol (TTP) based on the Unified~     Protocol; and b) a version of this protocol that also includes a specific component to~     address the regulation of positive affect (TTP+PA). Another aim was to assess the~     acceptability of both treatments by patients. It was hypothesized that the intervention would~     result in significant differences in favor of the TTP+PA protocol in all measures. Regarding~     acceptability, it was hypothesized that both treatments (TP and TP+PA) would be well-accepted~     by the two groups of participants.~   "
59340|NCT02790138|"~     The purpose of this study is to assess the efficacy and safety of vedolizumab intravenous~     (IV) in participants with a proctocolectomy and ileal pouch anal anastomosis for ulcerative~     colitis (UC) who have developed chronic or recurrent pouchitis, or require continuous~     antibiotic treatment.~   "
59311|NCT02790515|"~     This study seeks to examine treatment therapy that will reduced regimen-related toxicity and~     relapse while promoting rapid immune reconstitution with limited serious~     graft-versus-host-disease (GVHD) and also improve disease-free survival and quality of life.~     The investigators propose to evaluate the safety and efficacy of selective naive T-cell~     depleted (by TCRɑβ and CD45RA depletion, respectively) haploidentical hematopoietic cell~     transplant (HCT) following reduced intensity conditioning regimen that avoids radiation in~     patients with hematologic malignancies that have relapsed or are refractory following prior~     allogeneic transplantation.~      PRIMARY OBJECTIVE:~        -  To estimate engraftment by day +30 post-transplant in patients who receive~          TCRɑβ-depleted and CD45RA-depleted haploidentical donor progenitor cell transplantation~          following reduced intensity conditioning regimen without radiation.~      SECONDARY OBJECTIVES:~        -  Assess the safety and feasibility of the addition of Blinatumomab in the early~          post-engraftment period in patients with CD19+ malignancy.~        -  Estimate the incidence of malignant relapse, event-free survival, and overall survival~          at one-year post-transplantation.~        -  Estimate incidence and severity of acute and chronic (GVHD).~        -  Estimate the rate of transplant related mortality (TRM) in the first 100 days after~          transplantation.~   "
59312|NCT02790502|"~     Globally, about one-third of edible food is lost or wasted 1. Wasted food depletes resources~     used to produce the food (as a matter of definition, produce includes all activities to~     distribute, package and prepare food for human consumption at any venue, but does not include~     growing, transporting and processing), deprives hungry people from needed nutrition and~     represents the most common (>20%) and most environmentally deleterious component (in terms of~     greenhouse gas) of US landfills3-6. The Organization for Economic Co-operation and~     Development (OECD) identified reducing FW as a key to increasing global food security (OECD~     2011) 7. The Obama Administration recently announced a first ever FW reduction goal for the~     United States of 50% by 2030. USDA and EPA will pursue this goal via partnerships with the~     private sector, charitable and faith-based organizations, as well as state, local and tribal~     governments.~      In developed economies, consumers are the largest source of FW via home preparation and~     dining out2, 8. In order to achieve FW goals, we must anticipate how consumer FW generation~     and handling decisions will respond to proposed policies and interventions. However, there~     exist substantial barriers to measuring consumer FW: existing methods have high respondent~     burden and yield biased measurements of FW generation9-11. In this project we will test a~     smartphone application (app) for measuring household FW.~   "
59313|NCT02790489|"~     The objectives of this clinical study are to determine the tolerance of dietary supplement~     Valedia (blend of plant extracts) through the evaluation of several parameters :~        -  Various blood biological parameters for tolerance (preprandial): blood glucose, insulin,~          fructosamine, total cholesterol, triglycerides, HDL-cholesterol, LDL-cholesterol,~          oxidized LDL, us-CRP, creatinine, ASAT, ALAT, gGT, phosphatase alcaline, bilirubine,~          urea.~        -  Urinary parameters: urea, creatinine.~        -  Hemodynamic parameters: heart rate and blood pressure.~        -  Cardiac function: ECG.~        -  Weight.~   "
59314|NCT02790476|"~     In collaboration with the San Diego Medical Examiner's Office and the State of California's~     controlled Substance Utilization Review and Evaluation System (CURES), the investigators~     propose to review opioid poisonings over the past 12 months and will send letters to~     prescribers in California when at least one of the provider's prescription(s) was filled by a~     patient who died of an opioid poisoning in San Diego County. The letters will be~     non-judgmental and factual, explaining that a patient of the provider who was being treated~     with prescription narcotics died of an opioid poisoning. The letter will also encourage~     judicious prescribing including use of the CURES system before prescribing. The investigators~     will evaluate physician prescribing practices over 24 months 12 months pre- and 12 months~     post-letter using data from the CURES database. The investigators' hypothesis is that letters~     will make the risk of opioids more cognitively available and that physicians will respond by~     prescribing opioids more carefully. This will result in fewer deaths due to misuse and more~     frequent use of the CURES system.~   "
59315|NCT02790463|"~     The overarching goal of the investigators project is to identify best practices in gout and~     hyperuricemia management, translate these evidence-based practices into a highly~     generalizable strategy for optimal delivery of gout care, and implement and evaluate such a~     strategy in a large, population-based healthcare setting. With the use of novel but~     readily-accessible technology, the investigators will examine the use of a novel,~     large-scale, and relatively low-cost pharmacy-based intervention, with the goal of optimizing~     urate lower therapy (ULT) in chronic gout treatment.~   "
59316|NCT02790450|"~     Actual studies suggest that a calcium activated chlorid channel (TMEM16A) may play a relevant~     role in the pathogenesis of pulmonary arterial hypertension (PAH). The inhibition of this~     channel led to pulmonary vasorelaxation in preclinical studies. Benzbromarone is a well known~     inhibitor of the TMEM16A channel and is used in patients with gout.~      In this pilot study the investigators plan to investigate if Benzbromarone has an acute~     effect on the pulmonary arteries in humans. This will be investigated within the frame of a~     right heart catheterization performed in patients with known PAH due to clinical reasons. The~     investigators hypothesize that the application of Benzbromarone leads to pulmonary~     vasodilation, which can be recognized by the decrease in pulmonary vascular resistance. In~     addition, the change in pulmonary and systemic arterial pressure, pulmonary arterial wedge~     pressure, heart rate and arterial oxygen saturation will be assessed. Due to clinical reasons~     patients will receive NO (15 ppm) during right heart catheterization. Hemodynamic changes~     upon NO and Benzbromarone may be compared.~   "
59317|NCT02790437|"~     The purpose of this study is to evaluate the effectiveness of the study drug IdeS in patients~     who are on the waiting list for kidney transplant and have previously undergone~     desensitization unsuccessfully or in whom effective desensitization will be highly unlikely.~     At study entry, the patients will have an available deceased or live donor with a positive~     crossmatch test. The study will assess IdeS efficacy and safety in removing Donor Specific~     Antibodies (DSAs) and thereby convert a positive crossmatch test to negative.~   "
59318|NCT02790424|"~     Parameters, sequences or paradigms optimisation in view of data quality and relevancy~     improvement.~   "
59319|NCT02790411|"~     Parameters, sequences or paradigms optimisation in view of data quality and relevancy~     improvement.~   "
59321|NCT02790385|"~     Children with neuromuscular disorders such as cerebral palsy, children with kyphosis and~     post-traumatic scoliosis have higher infection rates after scoliosis surgery than healthy~     children who undergo scoliosis surgery. The purpose of our study is to compare the effect of~     NPWT on infection rates when compared to standard gauze dressing. Participants will be~     randomized to the NPWT or standard dressing group. We will compare infection rates~     between the two groups. We hypothesize participants in the NPWT group will have a lower~     infection rate.~   "
59322|NCT02790372|"~     This study evaluates the effect of using comprehensive geriatric assessment in combination~     with case conferences on the prevalence of neuropsychiatric symptoms (also known as~     behavioral and psychological symptoms of dementia) in Norwegian nursing homes~   "
59323|NCT02790359|"~     The safety and effectiveness of esophagogastroduodenoscopy and colonoscopy in the detection~     of gastrointestinal-tract pathology in children has been established during the last three~     decades. Insufflation of the intestinal tract, usually with room air, is necessary to improve~     visualization during the procedure; however, air in the bowels can also result in abdominal~     distension and increased pain. This potential discomfort associated with upper endoscopy and~     colonoscopy may be an important barrier to patients undergoing this procedure. Insufflation~     with carbon dioxide is another method used in endoscopic procedures for distention of the~     lumen and is currently used at the Children's Hospital of Wisconsin based on provider~     preference. The aim of this study is to perform a randomized controlled trial comparing~     insufflation with room air to carbon dioxide in patients undergoing routine upper endoscopy~     and colonoscopy. The investigators primary outcome is measurement of patient comfort level as~     measured by pain scores during recovery. The investigators hypothesize that carbon dioxide~     insufflation during endoscopy and colonoscopy improves patient comfort level as compared with~     insufflation with room air. Secondary outcome measures include changes in end tidal carbon~     dioxide, time to discharge, duration of colonoscopy and cecal intubation rate, changes in~     abdominal girth, rescue pain medications used during recovery and post-procedure events. This~     is a prospective randomized single-blinded study. The investigators will recruit consecutive~     patients, between the ages of 8 and 21 years, scheduled for elective outpatient upper~     endoscopy and colonoscopy at children's hospital of Wisconsin from March 2015 until we reach~     target population numbers. The investigators will exclude all inpatients, non-English~     speaking patients, children under 8 years of age, patients undergoing colonic manometry~     studies, and patients with hemodynamic instability, gastrointestinal bleeding, acute abdomen,~     previous colectomy, oxygen-dependent pulmonary disease and obstructive sleep apnea requiring~     the use of continuous positive airway pressure device. On the basis of a computer-generated~     randomization scheme in a 1:1 ratio, patients will be assigned to receive room air or carbon~     dioxide for insufflation during colonoscopy. Power calculation was done and determined that~     we will need to enroll 100 patients in each arm of the study. Informed consent will be~     obtained from all patients by the endoscopist or gastrointestinal fellow.~   "
59324|NCT02790346|"~     This study should refine our surgical indications and to establish a decision tree of medical~     and surgical treatment of this common and troublesome strain functionally which is~     equino-varus.~   "
59325|NCT02790333|"~     The purpose of this trial is to establish an objective criterion for assessing pancreatic~     stump texture, and unify stapler cartridge according to pancreatic stump texture and~     thickness.~   "
59326|NCT02790320|"~     The purpose of this study was to evaluate the efficacy and safety of eribulin in standard~     clinical practice in patients with locally recurrent or metastatic advanced breast cancer.~   "
59327|NCT02790307|"~     Tibial nerve stimulation (TNS) has been recognised as a safe and effective treatment for the~     management of overactive bladder (OAB) symptoms. The aim of this study was to evaluate~     safety, acceptability and pilot efficacy of transcutaneous TNS using a novel device.~   "
59328|NCT02790294|"~     This research study is evaluating suitability of a delayed magnetic resonance imaging (MRI)~     in management of spine tumors. Currently the standard of care is obtaining an MRI scan in the~     early postoperative period (within 72 hours after surgery). The purpose of this study is to~     see if delayed MRI (2 to 3 weeks after surgery) is similar in quality to the earlier MRI.~      In this study patients will undergo 2 MRIs after the surgery instead of one MRI. Patients~     will have one MRI about 3 days after the surgery and one MRI about 2-3 weeks after surgery.~   "
59329|NCT02790281|"~     The purpose of this study is to measure IL-6 and IL-6/sIL-6R complex levels in subjects with~     active moderate to severe ulcerative colitis or Crohn's disease.~   "
59330|NCT02790268|"~     To report the Ultrasound Biomicroscopic findings following Cionni Ring bag fixation and~     in-the-bag IOL Implantation. To assess the relationship of the Bag and Cionni ring~     positioning in relation to surrounding ocular structures, in pediatric eyes~   "
59331|NCT02790255|"~     The whole body calorimeter is sensitive enough to reliably measure cold-induced thermogenesis~     as a surrogate marker of brown adipose tissue (BAT) activation.~      The infrared (IR) energy flux from activated BAT can be accurately imaged and quantified~     using an IR imaging device, and that this IR energy output may be correlated to the increased~     energy expenditure quantified by the whole body calorimeter.~   "
59332|NCT02790242|"~     The purpose of this study is to gather information on patients who have heart failure and are~     eligible for one of the following two procedures: 1) mechanical support, i.e. ventricular~     assist device (VAD) or 2) heart transplant. the study seeks to determine which patient~     populations benefit from heart transplant or ventricular assist device. This will allow to~     offer the state-of-the-art care to the patients in heart failure.~   "
59333|NCT02790229|"~     The presented study is designed to prove efficacy of the anti-gravity treadmill (alter G®)~     compared to a standard rehabilitation protocol in patients with tibial plateau or ankle~     fractures with six weeks of partial weight bearing.~   "
59334|NCT02790216|"~     Objective:~      To focus the high dose radiation to the gross tumor in the prostate while maintaining~     adequate dose for control of microscopic disease elsewhere in the prostate.~      In order to test the incorporation of the robust MRI and TRUS fusion algorithm in the~     clinical setting the investigators planned a study of Focused therapy with a primary endpoint~     of accurate localization of the high risk region. This is a pilot study of dose painted~     permanent I-125 seed implant to verify absence of tumor cells outside a high risk region~     using multi-parametric MRI and deformable TRUS registration. The high risk region will be~     dose painted to 160 Gy and the rest of the prostate will receive the normal prescription~     dose.~   "
59335|NCT02790203|"~     Perioperative Celecoxib to promote bowel movement and to reduce post-operative pain after~     elective colonic resection.~   "
59336|NCT02790190|"~     This is a perspective, multicenter,randomized controlled trial to compare the efficacy and~     safety of radiotherapy Based on PET/CT and IMRT combined with concurrent chemotherapy in~     patients with locally advanced non small cell lung cancer . Analyses of overall survival (OS)~     will be done as defined in the protocol.~   "
59337|NCT02790177|"~     The objective of study is to determine the effect of hyaluronic acid on the formation of~     post-operative adhesions. It will be a randomized control trial comparing the product against~     normal saline.~   "
59343|NCT02790099|"~     Pain is the main obstacle in delaying postoperative recovery and leads to prolonged hospital~     stay. Administration of intrathecal morphine during spinal anaesthesia can provide effective~     pain control. However, it is associated with significant side effects including nausea,~     vomiting and itchiness. Also, it is not suitable in all patients, for example, those with~     morphine allergy, or severe respiratory disease. Surgical rectus sheath block involves~     injection of local anaesthetic agents into the rectus sheath space before closure of the~     wound. It has been shown to provide adequate pain control with less systemic side effects.~     The aim of the study is to evaluate the effectiveness of surgical rectus sheath block and~     intrathecal morphine in post-Caesarean section pain control.~   "
59344|NCT02790086|"~     The primary objectives of the study are~        -  to perform a survey on the clinical management of unintentional hypothermia during~          surgery in France.~        -  to assess the impact of perioperative hypothermia on anemia and myocardial injury.~   "
59345|NCT02790073|"~     To evaluate the effect of SNF472 on top of standard of care on promoting wound healing and~     other parameters of therapeutic response in haemodialysis patients with calciphylaxis~     (calcific uraemic arteriolopathy, CUA).~   "
59346|NCT02790060|"~     Subjects with type 1 diabetes are invited to provide usual blood glucose monitoring and a~     blood glucose profile (Pre/ post prandial Blood Glucose + Night Blood Glucose) on 3 occasions~     in a 2 week time period, in addition to the filling of 5 questionnaires including fear of~     hypoglycemia-2 questionnaire.~   "
59347|NCT02790047|"~     The aim of this study to investigate the efficacy of a home-base exercise program with a new~     conical PEP device on physical performance and health related quality of life in COPD~     patients.~   "
59348|NCT02790034|"~     This study evaluates the safety, tolerability and efficacy of Sarizotan in reducing~     respiratory abnormalities in Rett Syndrome.~   "
59349|NCT02790021|"~     Rationale: Breast cancer-related lymphedema (BCRL) is one of the most underestimated~     complications of breast cancer treatment with a reported incidence of 30% to 40% after~     axillary lymph node dissection (ALND) and 7% after sentinel lymph node biopsy (SLNB).~     Although the axillary treatment regimens are changing with a focus on less aggressive~     axillary treatment in order to reduce morbidity without compromising survival, BCRL will~     still remain a relevant problem in the future.~      Objective: To improve breast cancer survivorship by reducing/eliminating one of the most~     debilitating upper-body morbidities related to breast cancer treatment: chronic lymphedema of~     the arm.~      Study design: A multicenter, randomized controlled trial (RCT) carried out in the Maastricht~     University Medical Center, VieCuri Medical Center and Zuyderland Medical Center in the~     Netherlands.~      Study population: The study population includes all women over 18 years old who underwent~     surgical treatment for early stage breast cancer with an SLNB or ALND, or who received~     axillary radiotherapy, presenting with an early stage lymphedema of the arm (stage 1 and 2a~     on the ISL classification for lymphedema).~      Intervention: In this RCT patients are randomized over two arms: the first group will~     continue standard of care conservative lymphedema therapy, while the second group will~     undergo lymphaticovenous anastomoses (LVA) by a plastic surgeon.~      Main study parameters/endpoints: The main study parameters are the difference in excess limb~     volume (ELV) after one of both treatments, the effect of treatment on the quality of life and~     the cost-effectiveness of both treatments.~      Study-specific procedures: After randomization the follow-up moments will be at 3, 6, 9, 12,~     18 and 24 months. A follow-up moment includes an interview and a medical examination. During~     this examination, the upper limbs will be assessed for sensory, motor, strength and mobility~     changes. Furthermore, the investigators will measure the volume of the treated and untreated~     side using the water displacement method and circumference measurement. A lymphoscintigraphy~     is made at inclusion, after 12 months and after 24 months. Lastly, the subjects will be asked~     at certain time points to fill in five questionnaires: Lymph-ICF, EORTC QLQ-C30, EORTC~     QLQ-BR23, EQ-5D-5L and the DASH questionnaire.~   "
59350|NCT02790008|"~     Aortic valve disease causes impaired let ventricular function (LVF) due to hypertrophy,~     dilatation and diffuse myocardial fibrosis yet the prognostic effect of fibrosis, waiting~     time for operation and postoperative exercise training is presently unknown.~      The investigators aim to (1) determine the changes in LVF for patients on the waiting list;~     (2) establish non-invasive diagnostics for diffuse myocardial fibrosis; (3) relate LVF to~     fibrosis and physical capacity.~      The unique design (echocardiography, cardiopulmonary exercise test, cardiac magnetic~     resonance tomography and myocardial biopsy on the same patients) makes it possible to~     establish relationship between results of histology and imaging; quantifying and qualifying~     fibrosis in vivo, evaluate LVF vs. general cardiopulmonary function and optimize health care~     prior to and after operation.~   "
59351|NCT02789995|"~     Severe critical illness is often complicated by Intensive Care Unit - Acquired Weakness~     (ICU-AW), which is associated with increased in and post-ICU mortality, with delayed weaning~     from mechanical ventilation and with long-term functional. Several mechanisms have been~     incriminated in the pathophysiology of ICU-AW, but muscle regeneration has not been well~     investigated in this context, even though its involvement is suggested by the protracted~     functional consequences of ICU-AW. Recent data suggest that muscle regeneration could be~     impaired after sepsis, and that Mesenchymal Stem Cells (MSCs) treatment could improve the~     post-injury muscle recovery.~   "
59352|NCT02789982|"~     The purpose of this study is: (1) to examine the effectiveness of reconsolidation blockade as~     a treatment for trauma-related disorders, (2) to evaluate the feasibility of implementing~     this new treatment on a large scale in a short delay. This clinical trial as been set up in~     response to the Paris attacks to increase treatment capacity of the AP-HP (Assistance~     Publique des Hopitaux de Paris) hospital network.. Reconsolidation blockade will be compared~     to treatment as usual (TAU), on symptoms reduction after 6 weeks of treatment. In order to~     measure effectiveness and cost-effectiveness, socioeconomic measures, quality of life and~     social functioning outcomes will be measured pre- and post-treatment as well as 3 and 12~     months after study enrollment.~   "
59363|NCT02789839|"~     Oxidative stress is defined by an excess of reactive oxygen species (reactive oxygen species~     or ROS) in cells. ROS are essential to cell life (proliferation, differentiation), including~     kinase activity via inhibition of phosphatases. Very low levels of ROS are observed in~     quiescent cells, including hematopoietic stem cells. Conversely, an excess of ROS can induce~     DNA damage that may lead to the destruction of the cell.~      The level of ROS in cells is the result of production (mainly the NADPHoxydase and the~     mitochondrial respiratory chain) and their disposal via antioxidant enzymes. The hematology~     team of the university hospital of Tours (France) found that certain antioxidant enzymes are~     essential for the self-renewal of normal and leukemic cells such as glutathione peroxidase-3~     (Herault O et al, J Exp Med 2012, 209:895). Their expression is modified in hematological~     diseases (patent WO2012085188A1 / 2012-06-28 and FR1000267310 / 2014-11-27).~      Age potentially affects the level of expression of antioxidant genes, since it was~     established a decrease in glutathione peroxidase activity in women over 65 years (Sara E, J~     Gerontol A Biol Sci Med Sci 2008 63: 505). The study HEALTHOX will determine the impact of~     age on the oxidative metabolism of normal hematopoietic cells, and in particular the~     expression of antioxidant genes. It will provide a reference for analyzing disturbances of~     oxidative metabolism in blood diseases. The main objective is the comparison of peripheral~     blood and bone marrow cells depending from 3 groups of healthy volunteers: 18-39 years, 40-59~     years and 60-85 years. The level of ROS and the expression of genes encoding the major~     antioxidant enzymes involved in the regulation of oxidative stress will be studied. The~     secondary objectives are to create a cell bank (blood and marrow), a blood plasma bank and a~     cDNA library (blood and marrow) from healthy volunteers.~   "
59353|NCT02789969|"~     Every year over 1,000 children undergo eye muscle surgery provided by physicians at this~     institution. For many of these children this is not and will not be the only surgical~     procedure for eye muscle correction. All of these children will experience differing degrees~     of postoperative pain. The pain associated with strabismus surgery is due to the manipulation~     in the conjunctival area and further handling of Tenon's capsule, sclera and the stretching~     of the eye muscle . Research has demonstrated that repeated painful procedures result in~     increased anxiety and increased pain.~      Previous studies have demonstrated that children experiencing preoperative anxiety are more~     likely to have increased postoperative pain . This increased preoperative anxiety may also~     contribute to sleep difficulties and increased analgesic consumption. Depending on the age of~     the child, different methods are used to reduce anxiety such as distraction, child life~     services, or anti-anxiolytic agents.~      In addition to pain, children undergoing strabismus surgery frequently experience~     postoperative nausea and vomiting (PONV).This increased incidence of nausea and vomiting is~     thought to be related to the use of opiates for pain control. Short acting opiates are used~     preferentially at this hospital in the belief that this reduces recovery issues of sedation~     and PONV. Preliminary data, however, suggests no difference in recovery outcomes for fentanyl~     versus hydromorphone. The purpose of this study is to investigate the optimal analgesia to~     create a standardized approach for pain management in pediatric patients undergoing surgery~     for strabismus.~   "
59354|NCT02789956|"~     The aim of this study is to evaluate:~      Primary objective The primary objective of the present study is to evaluate the marginal bone~     level changes when partially edentulous patients, treated with implants, received a~     multiunits screw retained fixed dental prosthesis with a Co/Cr milled framework with an~     Internal or External connection.~      Secondary objective~        1. Overall survival rate.~        2. Soft tissue status by assessment of bleeding on probing (BoP) and probing pocket depth~          (PPD) at baseline and after 1,3,5 years.~        3. Prosthetic survival rates including screw or abutment loosening, framework or veneer~          fractures.~   "
59355|NCT02789943|"~     Integrated and cross-disciplinary analysis of human physiology and disease provides unbiased~     and deeply informative insights into human health and disease. In this study the~     investigators will recruit patients undergoing coronary artery bypass surgery to study the~     atrium of the heart or the aortic wall that when diseased can cause strokes.~      Hypothesis: Systems-level analysis of the left atrium and aorta cells that integrates~     imaging, histological, cellular and molecular data will identify new mechanism for~     cardiovascular form and function.~   "
59356|NCT02789930|"~     The purpose of this prospective single center study is to investigate if a developed program~     is more accurate than the anesthesia tape (Anästhesie-Lineal). For this study 1000 patients~     are required to collect anonymized data (length, weight, age, anesthesia material used during~     anesthesia) for achieving a power of 80% during statistical analysis. The main hypothesis ist~     that the program has a better accuracy than the anesthesia tape (Anästhesie-Lineal).~   "
59357|NCT02789917|"~     It is hypothesised that a dual therapy strategy by oral anticoagulation with the new~     Factor-Xa-inhibitor apixaban plus clopidogrel is superior to a triple therapy regimen with~     phenprocoumon plus acetylsalicylic acid (ASA) and clopidogrel with respect to avoiding~     bleeding events in patients with atrial fibrillation undergoing percutaneous coronary~     intervention in the setting of an acute coronary syndrome.~   "
59358|NCT02789904|"~     Current standard of care algorithm using high sensitivity troponin T (hsTnT) requires up to~     6.5 hours to diagnose an ACS. Data will be stratified based upon time of symptom onset and~     gender. A health economics and outcome model will be applied using the optimal high~     sensitivity troponin I (hsTnI) cut-off values and draw times to determine the cost and~     outcome benefits predicted from optimal utilization of hsTnI.~      A chest pain registry will be set up to compare high sensitivity troponin I (hsTnI) versus~     high sensitivity troponin T (hsTnT) for all patients who present to the emergency department~     and require a blood draw. The outcomes of these patients will be tracked over the study~     period.~      The purpose of conducting this study evaluation is:~        1. To shorten the chest pain protocol for suitable patients to < 3 hours compared to the~          current 6 hours protocol with the latest high sensitivity Troponin I assays.~        2. To determine the validity of Abbott ARCHITECT i2000 and Beckman Coulter ACCESS AccuTnI+3~          with an accelerated algorithm in comparison to the standard of care acute coronary~          syndrome (ACS) algorithm and high sensitivity troponin T (hsTnT) assay, to rule-out or~          rule-in for an ACS within 3 hours of presentation to the emergency room (ER) with~          isolated suspected ACS.~        3. To establish the local reference norms for hsTnI assays.~   "
59359|NCT02789891|"~     The purpose of this study is to explore the short-term, long-term and oncological outcomes of~     laparoscopic No. 14v lymph node dissection in advanced lower third gastric cancer.~   "
59360|NCT02789878|"~     This is a randomized study to evaluate the efficacy and safety neoadjuvant androgen~     deprivation therapy with goserelin and abiraterone with or without apalutamide prior to~     radical prostatectomy for patients diagnosed with localized high-risk prostate cancer.~   "
59361|NCT02789865|"~     Endoscopic retrograde appendicitis therapy (ERAT) is a new and minimally invasive method for~     the diagnosis and treatment of acute appendicitis.After a positive diagnosis of acute~     appendicitis is established by either colonoscopic direct-vision imaging or fluoroscopic~     endoscopic retrograde appendicography (ERA) imaging in patients with suspected acute~     appendicitis, the procedures to relieve the appendiceal lumen obstruction including~     appendiceal luminal irrigation, appendicolith removal, and stenting for drainage whenever~     necessary will be carried out. In this multicenter prospective randomized clinical trial, the~     patients with uncomplicated acute appendicitis will be divided into three groups randomly:~     ERAT group, antibiotic therapy group and appendectomy group. The primary outcome is duration~     of abdominal pain. The secondary outcomes include mean hospital stay, mean operative time,~     duration of fever, duration of leukocytosis, bed time, rate of complication, rate of~     recurrence and rate of appendectomy during follow-up period of 1 year.~   "
59362|NCT02789852|"~     Evaluation of the effectiveness of using a night orthosis for II and III or fingers of the~     dominant hand in women diagnosed with symptomatic osteoarthritis compared to a control group.~   "
59400|NCT02789358|"~     This study aims to validate a new dosage of cryotherapy based on time to effect in pulmonary~     vein ablation procedures in patients with paroxysmal atrial fibrillation.~   "
59364|NCT02789826|"~     The aim of surgical procedures for resection of cancer stomach is to resection of the tumor~     mass with safety margin and its drainage lymph nodes (lymphadenectomy).~      There are two main types of techniques (open & laparoscopic) Many studies were done comparing~     these two techniques showed that Laparoscopic resection is superior in early postoperative~     recovery (less pain ,less bleeding and shorter hospital stay) but less radical than open~     resection (less safety margin & less lymphadenectomy) but because of the ongoing advances on~     laparoscopic surgery these results needs more and more revision.~      So the investigators conduct this randomized controlled trial aiming at comparing open and~     laparoscopic resection of cancer stomach to choose the best surgical procedure for resection~     of cancer stomach.~   "
59365|NCT02789813|"~     The purpose of this study is to evaluate whether valproic acid in combination with fear~     memory reactivation is useful to enhance treatment stability of exposure therapy for specific~     phobia.~   "
59366|NCT02789800|"~     The aim of Patient-Centred Innovations for Persons With Multimorbidity (PACE in MM) study is~     to reorient the health care system from a single disease focus to a multimorbidity focus;~     centre on not only disease but also the patient in context; and realign the health care~     system from separate silos to coordinated collaborations in care. PACE in MM will propose~     multifaceted innovations in Chronic Disease Prevention and Management (CDPM) that will be~     grounded in current realities (i.e. Chronic Care Models including Self-Management Programs),~     that are linked to Primary Care (PC) reform efforts. The study will build on this firm~     foundation, will design and test promising innovations and will achieve transformation by~     creating structures to sustain relationships among researchers, decision-makers,~     practitioners, and patients. The Team will conduct inter-jurisdictional comparisons and is~     mainly a Quebec (QC) - Ontario (ON) collaboration with participation from 3 other provinces:~     British Columbia (BC); Manitoba (MB); and Nova Scotia (NS). The Team's objectives are: 1) to~     identify factors responsible for success or failure of current CDPM programs linked to the PC~     reform, by conducting a realist synthesis of their quantitative and qualitative evaluations;~     2) to transform consenting CDPM programs identified in Objective 1, by aligning them to~     promising interventions on patient-centred care for multimorbidity patients, and to test~     these new innovations' in at least two jurisdictions and compare among jurisdictions; and 3)~     to foster the scaling-up of innovations informed by Objective 1 and tested/proven in~     Objective 2, and to conduct research on different approaches to scaling-up. This registration~     for Clinical Trials only pertains to Objective 2 of the study.~   "
59367|NCT02789787|"~     Patients with cleft lip and palate frequently develop Class III (Cl III) malocclusions or~     underbites following early cleft repair surgeries. This clinical trial compares the current~     standard of care for treating the Cl III malocclusion, orthognathic (jaw) surgery after~     pubertal growth (16-21 years), with an alternative orthopedic approach to protract the~     maxilla during adolescence (11-14 years). At Children's Hospital Los Angeles(CHLA), early~     adolescents with cleft lip and palate and Cl III malocclusion are offered an alternative~     non-surgical approach to correct the malocclusion called maxillary protraction. Prior to~     age 14, the maxillary sutures have not fused and can be mobilized by alternating weekly~     expansion and constriction with a rapid palatal expander (RPE), thereby allowing the upper~     jaw (maxilla) to be pulled forward (protracted) to correct the underbite. This prospective~     parallel cohort study will assess the patients undergoing treatment for the Cl III~     malocclusion by either orthognathic surgery or maxillary protraction at four data collection~     time points during treatment. The data includes digitized study models, photographs and~     radiographs, quality of life surveys (SF12, YQOL), parent surveys (ASEBA), treatment cost,~     periodontal measurements and treatment complications. The study design is a descriptive~     cohort study that examines the success of treatment (% not requiring a second surgery), the~     dental and skeletal changes associated with treatment, the stability of treatment and the~     behavioural/adaptive factors (ASEBA) that contribute to success and lack of success for each~     treatment. The primary trial will be conducted at Children's Hospital Los Angeles and a pilot~     study to confirm translation to different settings will be conducted at Seattle Children's~     Hospital.~   "
59368|NCT02789774|"~     A multicenter randomized controlled trial is performed in Sweden (Uppsala, Malmo and~     Stockholm) comparing surgery with posterior C1-C2 fusion and conservative treatment with a~     rigid collar. Follow up will be performed up to one year after start of treatment registering~     EQ5D, NDI and cervical CT scans. Mortality will be documented during follow-up. All direct~     and indirect costs of treatment will be registered and used for cost-effectiveness analysis.~   "
59369|NCT02789761|"~     A randomised, placebo-controlled, parallel human dietary intervention trial conducted in 33~     healthy males to investigate the vascular and cognitive effects of bi-daily consumption of~     high-flavanol (epicatechin-rich) milk chocolate over a 2-week intervention period. Subjects~     visited the Hugh Sinclair Unit of Human Nutrition on 3 separate occasions; at the beginning,~     end and post-intervention.~   "
59370|NCT02789748|"~     This study aims at quantifying the performance of kinesthetic stimulation to reduce the~     burden of obstructive sleep apneas and hypopneas.~   "
59371|NCT02789735|"~     Persistent pregnancy-related pelvic girdle pain is common, 2-5% av all women given birth is~     suffering from disabling daily pain with high impact on quality of life.~      A prospective double-blinded randomised controlled trial will be performed with a baseline~     assessment 7-10 months after childbirth with follow-up directly and 6 months after a~     treatment period with low level laser therapy (LLLT) or sham laser treatment, given at 12~     planned treatment sessions during four weeks. 60 women will be included in the study.~      If LLLT can reduce pain and improve function there will be a new treatment option for this~     condition.~   "
59401|NCT02789345|"~     The main purpose of this study is to evaluate the safety of ramucirumab or necitumumab in~     combination with osimertinib in participants with non-small cell lung cancer (NSCLC).~   "
59446|NCT02788760|"~     Most fractures of the cervical spine are considered stable and treated with a rigid cervical~     collar. However no studies have to date been published addressing the length of treatment.~     There seems to be a significant dissimilarity between hospitals within and between countries~     with the length of collar treatment varying from 6 to 12 weeks. At the neurosurgical~     department at Oslo University Hospital, Ullevål the standard length of treatment for a stable~     cervical fracture is 12 weeks. This study seeks to establish whether 6 weeks of collar~     treatment for a specific subtype of stable fractures in the cervical spine is sufficient.~   "
59372|NCT02789722|"~     Mate or yerba-mate (Ilex paraguariensis A.St.-Hil.) is a native plant from South America~     highly consumed in this region. Different traditional products (mate, mate tea, chimarrao,~     tereré) are obtained from the yerba-mate leaves and consumed as herbal tea. Mate is a rich~     source of bioactive phenolic compounds, mainly caffeoylquinic acids. The richness of~     different mono- and dicaffeoylquinic acids is a peculiarity of mate derived products.~     However, in contrast to other plant-based beverages rich in polyphenols like tea or coffee,~     the research and the industry have yet little explored the potential interest of mate product~     to promote human health. There has been a growing interest to the development of healthier~     foods to face the burden of cardiovascular diseases (CVD), especially those naturally rich in~     bioactive phenolic compounds with protective effects against the development of chronic~     diseases. Different in vitro and animals studies associate the mate consumption with~     cardiovascular protection mechanisms. Consistent information about this activity and the~     long-term consumption effects in humans are scarce. The aim of this study is to assess~     through a randomized controlled trial the impact of chronic intake of mate on intermediate~     biomarkers of cardiovascular health in humans and to identify possible involved nutrigenomic~     mechanisms.~   "
59373|NCT02789709|"~     Predictive biomarkers are needed to identify those patients with higher risk of recurrence~     after surgery for colon cancer with curative intent. Our main objective is to determine a~     metabolite profile in blood plasma from patients operated from colorectal cancer that can be~     associated with the oncologic outcome and be validated as predictive biomarkers in future~     studies. A secondary objective is to study the glycolytic metabolism of colon cancer cell~     lines treated with plasma samples from the same patients. In particular, to validate the~     increased utilization of lactate by tumor cells as a metabolic substrate using postoperative~     human samples.~      Patients with colorectal cancer that have undergone surgical resection will be included.~     Plasma samples will be obtained before surgery and the 4th day and the 3rd, 6th, 12th, and~     18th months after surgery. Metabolic profiles in plasma samples will be determined using a~     kit that allows the quantification of 180 metabolites by mass spectrometry.~      A clinical follow up will be maintained for at least 2 years to identify tumor recurrences.~   "
59374|NCT02789696|"~     Prevalence of sleep apnea syndrome in patients with acromegaly is about 70%. It seems that~     comorbidities of arterial hypertension or type 2 diabetes are more severe in patients with~     acromegaly and sleep apnea syndrome. Besides sleep apnea syndrome associated to acromegaly~     gives rise to few symptoms, that explains it is under diagnosed. The mechanisms of the~     association are based on maxillofacial modifications linked to acromegaly, a thickening of~     soft tissues with deposits of glyco-aminoglycanes but probably also because of the associated~     obesity, of the potential existence of a goiter and a muscular dystrophy of the dilatative~     muscles of the pharynx.~      At present, no study clearly documented prevalence of acromegaly in a diagnostic consultation~     for sleep apnea syndrome.~   "
59375|NCT02789683|"~     The aim of this study is to compare the effects of emulsification and lipid droplet size on~     gastric emptying rate, and to determine if the change in gastric emptying rate can in turn~     influence postprandial glycemic, insulinemic and lipidemic responses.~   "
59376|NCT02789670|"~     New therapeutic approaches of MS are emerging, targeting different actors of the immune~     system. Some of them target a specific population of white blood cells: B lymphocytes~     composed of different subpopulations. The subsets of B cells express different functional~     properties that control the immune response, but these regulation mechanisms have yet to be~     clearly described. Some subpopulations could amplify inflammation through IL-6 production for~     example, whereas some ones contribute to its regulation through the production of IL-10.~     Using samples collected in a large cohort of individuals with risk of MS and treatment-naive~     patients in the early onset of the disease, the investigators aim to develop a 2 year~     follow-up study of the different blood B cells subset distribution and their functional~     properties in terms of pro- and anti-inflammatory cytokine production in MS. This approach~     can identify new biomarkers for monitoring of MS patients and lead to better define the~     indication use of depletive B cell drugs and not to counteract the regulatory action of these~     cells.~   "
59377|NCT02789657|"~     Neoadjuvant therapy is given to breast cancer patients whose cancers are relatively large or~     have spread to lymph nodes or both. The primary goal of this treatment is to prevent the~     cancer from coming back (recurring) elsewhere in the body, but if it makes the cancer in the~     breast and lymph nodes shrink it might be easier to remove. This could allow a patient to~     have a lumpectomy instead of a mastectomy and reduce the number of lymph nodes that the~     surgeon has to remove. In some cases, the neoadjuvant therapy works so well that it kills all~     of the cancer in the breast and lymph nodes. This is referred to as a pathologic complete~     response (pCR). Patients who achieve a pCR have a much lower risk of the cancer recurring~     elsewhere in their bodies.~      Investigators aren't sure which chemotherapy drugs work best with the HER2-targeted drugs,~     and what combination of these drugs causes the fewest side effects.Thus, this study has two~     main goals:~        1. To find out if treatment with wPCbTP, weekly paclitaxel and carboplatin given with~          trastuzumab and pertuzumab every 3 weeks, leads to as many pCRs as TCHP in patients with~          HER2-positive breast cancer, but has fewer side effects.~        2. To find out if HER2-positive patients whose cancers are not responding well after 12~          weeks of wPCbTP get a better response when they are switched to a doxorubicin-containing~          regimen called AC for 4 cycles (8-12 weeks).~   "
59378|NCT02789644|"~     A clinical study to investigate pharmacokinetics, metabolomics and biomarker in healthy~     elderly subject after ursodeoxycholic acid administration~   "
59379|NCT02789631|"~     Several factors have been associated with neck pain. Controversy exists regarding the degree~     of association between some of these factors and neck pain. Information regarding the degree~     of association of each factor to neck pain is needed for effective prevention and appropriate~     treatment strategies. The aim of this study is to investigate the association among~     musculoskeletal, sensorimotor factors and functional disability and occurrence of chronic~     nonspecific neck pain.~   "
59447|NCT02788747|"~     This is multi-center, randomized, double-blind, placebo-controlled study in patients with~     stable heart failure with reduced ejection fraction (HFrEF) to evaluate the effects of~     multiple subcutaneous injections of elamipretide on left ventricular function.~   "
71143|NCT02635776|"~     The purpose of this study is to demonstrate the efficacy and safety of AR101 through~     reduction in clinical reactivity to peanut allergen in peanut-allergic children and adults.~   "
59380|NCT02789618|"~     Subjects with at least two teeth with dentinal hypersensitivity and who meet the study~     criteria will be enrolled onto this double blind, randomised, parallel, controlled clinical~     trial. After enrolment, suitable subjects will use a fluoride toothpaste for 4 weeks (wash~     out period). Baseline dentine hypersensitivity assessments will be conducted using tactile~     stimuli, air blast, and VAS methods. Tactile methods of assessment will include use of the~     Yeaple Probe and the Jay Sensitivity Sensor probe. Air blast assessments will be conducted~     using the Schiff cold air sensitivity scale. The Oral Health Impact Profile (OHIP)~     questionnaire will be completed at four defined time points during the study. The baseline~     assessments will be conducted on the two teeth identified during the screening visit.~      On completion of the baseline assessments, subjects will be randomly assigned to product.~     Dentinal hypersensitivity assessments will be repeated after 18, 28 and 56 days of product~     use.~   "
59381|NCT02789605|"~     Recurrent aphthous stomatitis (RAS) is a frequent condition characterized by recurrent and~     painful oral ulcers with unknown pathophysiology. Recent studies suggest that a dysregulation~     of the oral microbiota may be implicated. Currently, therapies for RAS are limited by severe~     side effects or inconstant effectiveness. The aim of this study is to assess the~     effectiveness and safety of a probiotic, the Lactobacillus rhamnosus Lcr35® , in the~     treatment of RAS. A placebo-controlled, parallel study will be conducted in 40 subjects with~     RAS. Treatment consisted on the administration of the daily probiotics or placebo during 3~     months.All patients will be then followed up for additional 3months without treatment. The~     main outcome measure will be the number of occurring aphtae.~   "
59382|NCT02789592|"~     The purpose of this study is to determine whether melatonin prolonged-release (PR) and~     clonazepam are effective and safe in the treatment of rapid eye movement behavior disorder~     (RBD) of patients with Parkinson's disease (PD).~   "
59383|NCT02789579|"~     Minimally invasive upper tract lithotomy is currently a common operation method on treatment~     of urinary tract stones, but the postoperative complication urinary tract infection or~     urinary sepsis has turned into a serious threat to the patient's life, when severe, can~     result in a higher death rate.Although more the more importance were attached to, an~     effective prevention measures still have not been found.~      Among Urinary calculi, the higher rates of infection stone resulted in a higher incidence of~     postoperative urinary tract infection. The conventional postoperative prophylaxis medicine~     was the use of antimicrobial drugs half an hour before surgery.Foreign studies had shown that~     continuous preoperative one week use of nitrofurantoin can significantly reduce the incidence~     of urinary sepsis. So the investigators assume that preoperative extended use time of~     prophylaxis antibiotic may reduce the incidence of urinary tract infection or urinary sepsis.~      This study uses a computerized random method. According to preoperative use of different~     antimicrobial drug or treatment, all patients are randomly divided into five groups, namely~     levofloxacin 3days group,levofloxacin 7days group, nitrofurantoin 3days group,nitrofurantoin~     7days group and cefuroxime group.The levofloxacin group receives levofloxacin 0.5g, qd, po,~     the nitrofurantoin group was given oral nitrofurantoin 100mg, tid, po.to explore the better~     antibiotics types, medication timing and duration of treatment to prevent postoperative~     infection after minimally invasive upper tract lithotomy, so as to reduce the incidence of~     postoperative urinary tract infection or sepsis.~   "
59384|NCT02789566|"~     The primary objective of this study is to provide a description of the pharmacokinetic~     properties of primaquine and metabolites and characterize these in healthy obese Thai~     subjects.~      This is an open-label, single dose pharmacokinetic study in 10 healthy obese G6PD normal,~     subjects will be admitted as inpatient to receive 1 regimen for 1 visit only.~   "
59385|NCT02789553|"~     Despite an impressive capacity to induce diabetes remissions, the gastric bypass surgery has~     been associated with the onset of hyperglycemic peaks, which are very intensive and~     transient, in formally non diabetic patients. The aim of this study is to study the digestion~     of starch as compared to that of glucose (same glucose load) before and after gastric bypass~     surgery in obese patients.~      Volunteers will be recruited among the candidates to a gastric bypass, and will be studied~     before and 3 months after surgery. They will have on each occasion 2 random meals,~     corresponding to 30g glucose, one made of starch the other made of glucose, both naturally~     labeled with 13C. The digestion of starch will be assessed with the increase in the plasma~     13C-glucose tracer. Plasma samples will be collected for 3 hours.~      Some studies have already investigated time of absorption of glucose, but any study has~     examined the time of digestion of glucose. Other study always used glucose syrup, so they~     cannot have results about digestion. It is the reason why, in this study, glucose syrup and a~     starch meal will be taken by the same patient and glycaemia will be compared. In this way,~     results will be obtained about the kinetic of digestion of starch.~   "
59386|NCT02789540|"~     This is a multi-country, multicentre, observational prospective data collection cross~     sectional study of patients with stable COPD in Latin America. Primary objective is to assess~     and characterize COPD symptoms over a period of 24 hours, by collecting information about the~     respiratory symptoms experienced at different times of the day and night-time in patients~     with stable COPD under real clinical practice conditions. Correlation between each of these~     symptoms and the Global Initiative for Chronic Obstructive Lung Disease (GOLD)~     classification, adherence to respiratory treatment, level of dyspnea, disease severity,~     comorbidities and physical activity as well direct costs will be done as secondary~     objectives. Study population are patients of 40 years and older, smokers or ex smokers of >=~     10 pack/years with previous COPD diagnosis, attending outpatient specialists consults in~     Argentina, Chile, Colombia, Uruguay, Costa Rica, Guatemala and Mexico. Sample size is~     targeted to 900 enroled patients in order to ensure 860 patients to achieve statistical power~     to primary objective.~   "
59402|NCT02789332|"~     This is a multicenter, prospective, randomized, open-label phase II study evaluating the~     efficacy and safety of PO→EC as neoadjuvant treatment of operable and locally advanced breast~     cancer in patients with HR deficiency. Patients will be randomized to receive~        -  paclitaxel 80 mg/m² iv weekly in combination with olaparib tablets 100 mg (4X25mg) twice~          daily for 12 weeks (65 patients) or~        -  paclitaxel 80 mg/m² iv weekly in combination with carboplatin AUC 2 iv weekly for 12~          weeks (37 patients) both followed by 4 cycles of epirubicin 90 mg/m² and~          cyclophosphamide 600 mg/m² (EC) either every 3 or every 2 weeks followed by surgery.~      The control arm was chosen to allow direct comparison with one of the currently considered~     standard of care regimen.~   "
59387|NCT02789527|"~     Physicians know that their patients can react differently to the same medical treatment: for~     some of them, the drug will prove inefficient, whereas for others it might provoke~     side-effects, sometimes rather serious. Such differences in response to drug intake are due~     to several factors, of which molecular variations in specific genes, named  ADME ~     (Absorption, Distribution, Metabolism, Excretion). This project aims at investigating the~     evolutionary mechanisms responsible for the diversity of ADME genes in human populations.~     Because of their role at the interface between the organism and its chemical environment,~     ADME genes are likely targets of recent selective pressures linked to changes in the~     environments in which humans evolved, such as changes in dietary habits for instance.~      The aim of this project is to study the diversity of ADME genes and of their expression in~     five populations located along a latitudinal axis that extends from East Africa to Central~     Europe, passing through the Arabian Peninsula and the Mediterranean area, so as to take into~     account environmental factors that might have influenced the evolution of this diversity.~     This project is thus intended to evidence the evolutionary mechanisms that shaped genomic~     regions that are functionally important from the clinical and epidemiological point of view.~     Moreover, it will allow us to extend the knowledge of human molecular diversity and its~     evolution to a key-region of the peopling history of our species.~   "
59388|NCT02789514|"~     Esophagogastroduodenoscopy (EGD) become more and more common in diagnosing gastroenterology~     diseases. The investigators want to find which symptoms can support for positive endoscopic~     findings.~   "
59389|NCT02789501|"~     Catheter infections and dysfunctions are a major cause of morbidity and mortality in~     haemodialysis patients. According to the US Renal Data System, infection is the second~     leading cause of death in dialysis patients and the leading cause of catheter removal and~     morbidity in patients with end-stage renal disease.~      There is evidence that catheter lock solutions containing taurolidine reduce the risk of~     catheter related infections and improve catheter patency. Lock solutions have a local, but no~     systemic effect. In this study a taurolidine based lock regimen (TauroLock™-Hep500,~     Tauropharm, Waldbüttelbrunn, Germany, 2x/week and TauroLock™-U25.000, Tauropharm,~     Waldbüttelbrunn, Germany, 1x/ week) will be compared to 4% citrate (CitraFlow™ 4%, MedXL,~     Montreal, Canada, 3x/week) as standard lock solution.~      The objective of this study is to evaluate if a TauroLock™ based regimen to lock tunneled~     haemodialysis catheters has reducing effects on catheter related blood stream infections and~     catheter dysfunctions.~   "
59390|NCT02789488|"~     Poly cystic ovary syndrome (PCOS) is a disease which is prevalent in women of reproductive~     age facing obesity along with increased risk of type-2 diabetes and high cholesterol levels.~     The genetically determined cause of the PCOS includes disturbed levels of insulin and~     androgens. Standardized fenugreek seed extract (Furocyst) contains compounds such as saponins~     & flavonoids which act on the insulin and indirectly helps to regulate the androgen levels in~     the body.~   "
59391|NCT02789475|"~     An open-label, multiple-dose study to evaluate the pharmacokinetic drug-drug interaction of~     amlodipine and rosuvastatin in healthy adult male subjects.~   "
59392|NCT02789462|"~     This is a multi-center, investigator initiated study that will prospectively and~     retrospectively examine treatment strategies and outcomes of patients who underwent~     percutaneous coronary interventions (PCI).~      The goal of this multi-center, investigator initiated, registry is to collect information on~     treatment strategies and outcomes of consecutive patients undergoing laser-assisted PCI among~     various participating centers. The study is a purely observational, chart review study and~     involves retrieval and compiling of data based on clinically indicated procedures and~     follow-up clinical and procedural outcomes.~      The information collected will be used to determine the frequency of laser-assisted PCI~     performed at the participating sites and examine the procedural strategies utilized, and the~     procedural (both immediate and subsequent) outcomes.~   "
59393|NCT02789449|"~     The aim of the study is to investigate the role of the non-invasive assessment of nitric~     oxyde (NO) diffusion capacity (DLNO) in the differential diagnosis of different forms of~     pulmonary hypertension (PH). DLNO alone and in combination with the measurement of carbon~     monoxide (CO) diffusion capacity (DLCO) may help to differentiate between pre- and~     postcapillary forms of pulmonary hypertension. This hypothesis is based on the fact that NO~     has a much higher affinity to hemoglobin as compared to CO and may therefore its decrease may~     more specifically identify the limiting factors between the alveolar space and the lung~     capillaries including left heart failure (cardiac edema).~      As there are no available published data yet to answer this question investigators aim to~     perform a small pilot study. The results of this study may allow the planning of a~     prospective study.~   "
59394|NCT02789436|"~     The purpose of this study is to determine whether Lactobacillus reuteri-containing lozenges~     (Prodentis) are effective in treatment of halitosis in patients with chronic periodontitis.~   "
59395|NCT02789423|"~     The purpose of this study was clinical and radiographical evaluation of the effect of calcium~     hydroxide cement (Dycal) and calcium silicate cement (Biodentine) in direct pulp capping in~     primary teeth.~   "
59396|NCT02789410|"~     Intrathecal (IT) opioids are commonly administered with local anesthetic during spinal~     anesthesia for post-Cesarean delivery analgesia. Traditionally, IT morphine has been used but~     the use of IT hydromorphone is growing. A previous study has shown that the effective dose~     for postoperative analgesia in 90% patients (ED90) for both IT hydromorphone and IT morphine~     (NCT02009722). These doses were found to be 75 mcg for hydromorphone and 150 mcg for~     morphine. The current proposed study would compare the duration of analgesia of IT morphine~     vs IT hydromorphone after elective cesarean delivery. Additionally, the investigators will~     compare each drug with respect the incidence of nausea and pruritus.~   "
59397|NCT02789397|"~     This phase II study will assess the effect of a treatment combination of Rituximab and~     azathioprine in patients with Granulomatous and Lymphocytic Interstitial Lung Disease (GLILD)~     compared to placebo, based on change in lung function at 18 months compared to baseline. The~     researchers will also assess if the drugs improved quality of life.~   "
59398|NCT02789384|"~     This is a prospective observational biomarker study including patients with non-metastatic,~     soft-tissue sarcomas (STS) for whom neoadjuvant chemotherapy is considered as the best option~     by the multidisciplinary sarcoma team of one of the participating centers.~   "
59399|NCT02789371|"~     The purpose of this study is to compare the diagnosis accuracy of modified wet suction~     technique and 5ml dry suction technique on solid occupying lesions.~   "
59403|NCT02789319|"~     The blanket protocol covers the execution of the Diabetes Technology Society (DTS) Blood~     Glucose Monitor System Surveillance Program that will consist of a series of similar accuracy~     sub-studies with marketed Blood Glucose Monitor Systems (BGMS) conducted by the Clinical and~     Laboratory site(s) chosen for this study. The two parts of the study (BGMS testing and~     comparative glucose analyzer testing) will be conducted in separate facilities (clinical site~     and laboratory site) so the clinical and laboratory investigators will be blinded from each~     other's results.~      To access the full protocol:~     http://dst.sagepub.com/content/early/2015/12/10/1932296815614587.full.pdf+html~      The clinical site(s) will recruit subjects and test their fingerstick blood directly on the~     Blood Glucose Monitor Systems. Tubes of fingerstick blood will also be collected from the~     same subjects, centrifuged and the plasma collected and frozen for shipment to a Clinical~     Laboratory Improvement Amendments (CLIA)/College of American Pathologists (CAP) certified,~     accredited clinical chemistry laboratory for measurement on a comparative glucose analyzer.~     In addition, National Institute of Standards and Technology (NIST) glucose standards (965b)~     will be assayed on the comparative glucose analyzers to determine any bias from the true~     glucose values established by the reference mass spectrometry method.~      This series of sub-studies will assess the accuracy of various BGMSs by trained~     professionals, not by the intended end user. Only accuracy of the BGMSs when tests are~     performed by trained study staff will be assessed. Understanding by the end user of~     instructions for use (labeling) and human factors analysis are not within the scope of this~     protocol.~   "
59404|NCT02789306|"~     In the field of periodontics, periodontal support therapy has proven to be essential in~     preventing the incidence or recurrence of periodontal diseases. The protocol is designed~     according to the risk profile of a patient. For example, in the presence of the history of~     periodontal therapy, subgingival microbiota containing large numbers of spirochetes and~     mobile rods can recolonize pockets 4-8 weeks after scaling. Similarly, routine maintenance of~     dental implants has been recommended to prudently avoid peri-implant inflammation, Indeed,~     the understanding of the nature of the tissue around the implant and its pattern of disease~     would be important to consider, even surpassing importance. Recently, a systematic review by~     our group has identified the importance of maintenance therapy around implants because it can~     help prevent about 3 times patient-level frequency peri-implantitis.~      Henceforth, our primary goal was to study the influence in a cross-sectional study of the~     frequency of peri-implantitis patients according to their post-implant placement and~     corresponding prosthesis visits supportive peri-implant maintenance. As such, it will be~     shown:~        1. What are the local and systemic factors affecting the appearance of peri-implantitis~        2. The ideal frequency of supportive peri-implant maintenance in patients who do not~          develop peri-implant disease~        3. What is the population of patients who come to supportive peri-implant maintenance after~          placement of dental implants~   "
59405|NCT02789293|"~     The purpose of the this study is to collect safety and efficacy data on Focused Ultrasound~     treatment (UCP procedure) in open angle glaucoma patients without previous glaucoma surgery.~   "
59406|NCT02789280|"~     The main goal of this study was to compare the effect of a one-session unsupported Internet~     intervention on participants' clinical symptoms (depressive and anxiety symptoms) and related~     variables (mood, confidence and motivation).~   "
59407|NCT02789267|"~     Undernutrition in cancerology is frequent because it's present for thirty to fifty percent of~     the patients at the time of the diagnosis. According to the recommendations of the French~     Speaking Society of Clinical Nutrition and Metabolism (SFNEP) of November 2012, a five~     percent loss of weight compared to the previous weight increases the risk of toxicity of the~     chemotherapy and worsens the patient's quality of life.~      The treatment of the tumors of the head and the neck comes along very often with a loss of~     weight (17.4 % after one year of radiotherapy according to the study of Larsson et al.) which~     varies with the chosen treatment, and shows a major risk at the patients whose therapeutic~     sequence involves a radiotherapy. The irradiation of the upper aerodigestive tract is source~     of aftereffects and late complications: xerostomia, oedemas of mucous membranes.~      The xerostomia, connected to the damage of the salivary glands, is a frequent complaint of~     the patients. It reveals or even increases, a dysphagia. According to Woisard, six months~     after the end of treatments, forty percent of the patients suffer from a dysphagia.~      All these complications limit quantitatively and qualitatively the food intake. The~     adaptation of the texture of the food is necessary by fifty four percent at three months of~     the end of treatments according to Logemann et al., and a few patients remain dependent on an~     long term enteral nutrition.~      Beyond a change of the nutritional state, the feeding difficulties or even the absence of~     resumption of an oral feeding are responsible for a social isolation. The meal which lost its~     dimension of pleasure becomes a source of fear and obsession for the patient as well as for~     his relations, and this fact generates family tensions. The quality of life of the patient is~     heavily affected.~      Ravasco showed in his study that the impact on the nutritional state of a nutritional care by~     dietary advices was more important as the prescription of oral nutritional supplements but~     based on a short period (the dietary intervention covered only the duration of the~     radiotherapy). But what would happen after the end of treatments? The investigators emit the~     hypothesis that a post-therapeutic systematic and regular dietary support has a positive~     impact on the prevention of the undernutrition among the patients affected by a first cancer~     of the upper aerodigestive tract whom therapeutic sequence involves a radiotherapy.~   "
59408|NCT02789254|"~     This is a first in human, prospective, monocentric, nonrandomized, open-label study to~     investigate the safety, tolerability, preliminary efficacy, pharmacokinetics,~     pharmacodynamics and immunogenicity of the Fc-optimized antibody FLYSYN as monotherapy in~     adult subjects.~   "
59409|NCT02789241|"~     The purpose of this study is to evaluate 4-dose levels of CCRE Lot 94332B1 (0.6, 1.0, 2.0,~     and 4.0 ng/kg). This study is known as, an endotoxin challenge. Thousands of healthy~     subjects worldwide over the last 20 years have participated in endotoxin challenge studies as~     part of clinical research and clinical drug development programs. This study will only test~     the safety and tolerability of CCRE Lot 94332B1.~   "
59410|NCT02789228|"~     Patients with high-risk solid tumors, those that are refractory to standard up front therapy~     or relapse after completion of therapy, have a very poor prognosis despite attempts to induce~     remission with salvage regimen. Novel therapies are critical for this patient population with~     high-risk cancer.~      The ability of tumors to be recognized and lysed by the immune system offers a unique~     opportunity to aid in tumor eradication by expanding and activating these anti-tumor cells.~     Through this ability to harness sophisticated and specific immunotherapy, residual or~     relapsed disease that is resistant to chemotherapy and/or radiotherapy could be eradicated.~     Prior studies have suggested both safety of expanded specific T cells and efficacy in the~     setting of melanoma, lymphoma or viral eradication. While this therapy has previously been~     limited by the versatility of the tumor to down-regulate antigens and evade a single~     immune-target, the use of multi-antigen specific T cells may permit better and more durable~     anti-tumor immunity. Thus, the investigators propose to infuse these specific multi-antigen~     anti-tumor T lymphocytes into patients with high risk solid tumors. This trial will be~     conducted to demonstrate safety of these cells and generate efficacy and biology data that~     may be important for future studies that may enhance tumor immunotherapy.~   "
59411|NCT02789215|"~     Child and Adult Care Food Program (CACFP) meals are an important influence on diets of~     children from low-income families enrolled in the CACFP and should meet children's nutrient~     needs while fostering healthy eating habits that enable them to maintain energy balance.~     Recent national data revealed that children consumed low intakes of foods that support~     healthy dietary patterns (whole grains, fruit and vegetables other than potatoes), but high~     intakes of low nutrient, energy dense foods. The 2011 USDA-commissioned Institute of Medicine~     (IOM) report for CACFP meals provided new recommendations that include new meal pattern~     requirements for the meals programs, aligning them with the U.S. Dietary Guidelines to ensure~     that the meals promote health and reduce inadequate and excessive intakes. The report~     recommended inclusion of more whole grains, fruit, vegetables, and meat/meat alternatives~     which will likely increase meal costs. Two of the IOM report recommendations call for~     research to better understand how the new meal requirements would change children's CACFP~     meal dietary intakes and food service costs. These are important questions, and answers are~     needed to inform policy and future technical and educational assistance needs. The overall~     objective of this project is to implement the IOM meal pattern requirements for CACFP meals~     in day homes and centers in Texas. The multidisciplinary team will focus on nutrition,~     economics, and provider outcomes. The specific aims are to assess the impact of the new meal~     pattern requirements on 1) Meal participation rates; 2) Provider food service costs (food,~     labor, total meals); and 3) Child dietary intake at CACFP homes and centers. It is~     hypothesized that, compared with control sites, intervention site children will select and~     consume healthier diets (more fruit, vegetables and whole grains) at school. A total of 32~     day care sites will be recruited for the study. It is hypothesized that, compared with~     control sites, children at the intervention sites will select and consume healthier diets~     (more fruit, vegetable and whole grains) at the center. It is also hypothesized that the~     increase in food costs will be less than that projected in the IOM report. The results on the~     costs associated with creating the desired meals will be very important as these data have~     not been systematically collected in previous studies. This significant study targets~     underserved minority populations with health promoting intervention to reduce health~     disparities, and in addition, will inform policy on the influence of a healthy food~     environment on children's diet, as well as provide critical information on costs.~   "
59412|NCT02789202|"~     This study aims to verify the actual possibility of using silver diammine fluoride (SDF) in~     arresting enamel caries lesions on occlusal surfaces of primary molars in babies. Besides,~     the cost-efficacy and also parental acceptability of using SDF will be evaluated. For this,~     100 babies 1-3 years will be examined and treated in a mobile dental unit, which will~     temporarily be parked in public schools of Barueri, Sao Paulo, Brazil. The caries diagnosis~     will be conducted using the International Caries Detection and Assessment System (ICDAS).~     Babies with initial lesions will be randomized concerning the treatment in Group A (SDF) and~     Group B (fluoride varnish). Participants will be examined in the baseline and followed by 6,~     12, 18 and 24 months. As primary outcome, caries progression into dentine will be considered.~     Acceptability reported by parents after treatments, the time and estimated money spent for~     treating will also be collected. Social and biological data that could be related to efficacy~     of techniques will be also collected. Multilevel analyses will be performed to check which~     technique will be most effective and possible factors associated to its efficacy. Discomfort,~     acceptability and costs will be compared between/among the approaches used to arrest enamel~     caries lesions.~   "
59413|NCT02789189|"~     The purpose of this single arm,phase Ⅱ clinical trail is to determine the safety and efficacy~     of nedaplatin combined with gemcitabine in the treatment of recurrent and metastatic~     nasopharyngeal carcinoma~   "
59414|NCT02789176|"~     The purpose of this study is to examine whether the duration of treatment with phenobarbital~     has an impact on neurodevelopmental and epilepsy outcomes, as well as parent and family~     well-being, after neonatal seizures.~   "
59415|NCT02789163|"~     Women age >18 scheduled for a diagnostic ultrasound examination had both a hand held~     ultrasound and an automated breast volume scan. Exams were performed by different~     technologists. Images were blinded and blinded read for diagnostic accuracy of the two~     examinations~   "
59416|NCT02789150|"~     Comparing renal outcomes based on a Mean Arterail Pressure (MAP) of 65-7085mmhg versus a MAP~     of greater than or equal to 85mmhg~   "
59417|NCT02789137|"~     The purpose of this study is to know about the quality of life of patients with metastatic~     renal cell carcinoma who are being treated with sunitinib, pazopanib or sorafenib, and who~     suffer from fatigue and hand-foot syndrome, with personal inter-variability, and to explore~     measures that can be taken in terms of both everyday lifestyle and treatment to mitigate or~     cure such side effects that affect patients.~   "
59418|NCT02789124|"~     Difficulties in the accurate assessment of intravascular volume in critically ill patients~     are frequently encountered. In addition to clinical evaluation, bedside echocardiographic~     measurements of fluid responsiveness can be technically difficult, especially in critically~     ill mechanically ventilated patients. The carotid artery is an easily accessible structure~     that is amenable to bedside ultrasonography performed by Intensivists. The investigators~     hypothesize that measurement of the carotid artery Corrected Flow Time (FTC) in response to a~     passive leg raise (PLR), which simulates a fluid bolus, can be used to predict fluid~     responsiveness.~   "
59419|NCT02789111|"~     The Investigator has chosen to study the reconstructive spinal surgery patient population~     because it is believed that the use of alvimopan in these patients at the University of~     Virginia will give the scientific community significant insight into the broader~     applicability of this drug into other surgical populations, the impact of this drug on the~     perception of pain (as opposed to simply the consumption of opioids), and its impact on total~     hospital charges, resource utilization, and functional outcomes.~   "
59420|NCT02789098|"~     Left ventricular remodeling is a common complication in patients with ST-elevation myocardial~     infarction (STEMI ) and may lead to heart failure. Hemodynamic, metabolic and inflammatory~     mechanisms are involved in this pathophysiological process. Recent data demonstrated that~     remote, noninfarct-related region of the myocardium is also implicated. There is no data~     about the assessment of coronary endothelial function or myocardial fibrosis in the remote~     zone in patients with STEMI . The correlation between these parameters and left ventricular~     remodeling is not known.~   "
59435|NCT02788903|"~     The overarching goal of this proposal is to understand the comparative effectiveness of~     obesity counseling as covered by CMS in improving weight loss for adults either with or at~     high risk of type 2 diabetes. CMS and most insurers now include obesity screening and~     counseling benefits, with no cost sharing to patients. Since overweight patients are at~     highest risk for diabetes, improved weight management services could prevent diabetes and its~     negative health outcomes. Beneficiaries with obesity are eligible for up to 20 face-to-face~     visits for weight counseling in the primary care setting. We propose comparing weight and~     diabetes outcomes in three states using EHR and claims data before and after this policy was~     implemented by leveraging the novel infrastructure of the Patient-Centered Outcomes Research~     Institute-funded PaTH Clinical Data Research Network.~   "
60370|NCT02776657|"~     This study involves the use of Magnetic Resonance Imaging (MRI) to determine whether blood~     clots can be identified within the blood vessels supplying blood to the heart in patients~     with angina and who have recently suffered a heart attack.~   "
59421|NCT02789085|"~     Using computerized pupillometry, previous research established that the autonomic nervous~     system (ANS) is dysregulated in patients who suffer from temporomandibular disorders (TMDs),~     suggesting a potential role for ANS dysfunction in pain modulation and the etiology of TMD.~     However, pain modulation hypotheses in TMD are still lacking.~      The periaqueductal gray (PAG) is involved in the descending modulation of defensive behavior~     and pain through μ, κ, and δ opioid receptors. Transcutaneous electric nerve stimulation~     (TENS) has been extensively used for pain relief, as low-frequency stimulation is able to~     activate µ receptors. The aim of the present study is to use ANS polygraph and salivary/serum~     biomarkers to evaluate the effect of low-frequency TENS stimulation of ANS in TMD patients.~      According to the Research Diagnostic Criteria for TMD, people with myogenous TMD and~     matched-controls will be enrolled. All subjects will be randomly assigned to control group~     (no tens stimulation) and case group (test stimulation); subsequently, ANS parameters by both~     biomarkers and ANS polygraph, before, soon after (end of stimulation), and late after~     (recovery period) sensorial TENS will be collected.~      The overall statistics will be performed from all conditions recorded comparing controls vs~     cases.~      The expected results consist in discovering ANS deregulation in TMD with and without TENS~     stimulation.~   "
59422|NCT02789072|"~     Cardiovascular events remain the main cause of death of the industrialized world (Global~     status report on noncommunicable diseases 2010. Geneva, World Health Organization, 2011).~     Arterial hypertension, hyperlipoproteinemia, smoking, diabetes and family history represent~     the main cardiovascular risk factors. Arteriosclerosis leads to coronary heart disease,~     cerebrovascular insufficiency and peripheral vascular diseases that reflect in myocardial~     infarction and stroke.~      The main objective of this experiment is to investigate the differential effect of~     microgravity on central aortic blood pressure.~      The main criterion is the central aortic pressure (measured in mmHg). The hypothesis is that~     microgravity leads to an increased central aortic pressure.~   "
59423|NCT02789059|"~     Previous studies showed modifications of muscle oxygenation parameters in muscular~     dystrophies du to an impairment or an absence of dystrophin.~      Our study aim at assessing muscle oxygenation during effort in different neuromuscular~     diseases (muscular dystrophies related and not related to dystrophin, non dystrophic~     myopathies and motor neuron diseases) compared to a group of healthy controls. Patients and~     controls are invited to perform an inframaximal , standardized effort of the knee extensors~     by the mean of an isokinetic dynamometer. Muscle oxygenation parameters are assessed through~     a Near Infrared Spectroscopy (NIRS) Device.~      In patients affected by dystrophin related myopathies, a muscle biopsy will be performed in~     order to analyse mitochondrial oxygenation parameters and mitochondrial phenotype.~      Our Hypothesis is that muscle oxygenation is impaired in dystrophin related muscular~     dystrophies compared to other neuromuscular diseases and healthy controls because of lack of~     muscle capillary vessels dilatation during effort and impairment of mitochondrial function.~   "
59424|NCT02789046|"~     The objective of the prospective multicenter observational study consists in defining a~     difficult intravenous access score in adult, during the preoperative period.~      The main objective: the outcome of interest is defined as failure of cannulation on first~     attempt.~      The risk factors of failure of cannulation on first attempt will be described. Adjusted~     multivariate models will be constructed. A prediction model will be proposed according to the~     transparent reporting of a multivariable prediction model for individual prognosis or~     diagnosis (TRIPOD)~   "
59425|NCT02789033|"~     The prevalence of diabetic foot ulceration in the diabetic population is 4-10%; the condition~     is more frequent in elder patients. It is estimated that about 5% of all patients with~     diabetes present a history of foot ulceration, while the lifetime risk of diabetic patients~     developing this complication is 15%. The majority (60-80%) of foot ulcers will heal, while~     10-15% of them will remain active, and 5-24% of them will finally lead to limb amputation~     within a period of 6-18 months after the first evaluation , 2 out of 3 patients with a limb~     amputation could also be involved in a new amputation in the next year; higher or in the~     other leg , Eighty-five percent of lower-limb amputations in patients with diabetes are~     preceded by foot ulceration. The management of chronic diabetic foot ulcers (DFU) suggests~     multi-disciplinary approaches including control of diabetes, orthotic shoe wear, off-loading~     device, wound care and surgery in selected cases. However, treatment of DFU remains~     challenging because of unsatisfactory results from surgical and non-surgical treatments. Many~     adjunctive therapies are designed to improve the care of DFU including negative pressure~     wound therapy , ultrasound, recombinant human platelet-derived growth factor-BB (rPDGF-BB)~     Hyperbaric oxygen and acellular matrix product among others.~   "
59426|NCT02789020|"~     Parkinson's disease (PD) is a neurodegenerative brain disorder that impairs the ability to~     perform functions such as grooming, dressing, cooking, and other activities of daily living.~     PD affected between 4.1 and 4.6 million people worldwide in 2005, and it is projected that up~     to 9.3 million people will be affected by 2030. Although current pharmacological therapies~     provide beneficial effects on motor symptoms of the disease (tremor, rigidity, and~     bradykinesia), intolerable disability eventually develops in most patients. A~     disease-modifying therapy that slows disease progression is a major unmet medical need in PD.~     Numerous agents have neuroprotective effects in pre-clinical laboratory models, but none have~     been shown to have indisputable disease-modifying effects in clinical trials for patients~     with PD.~      The purpose of this research study is to investigate how the brain and motor behavior changes~     in PD over time in response to rasagiline which is a monoamine oxidase-B(MAO-B) inhibitor.~     The drug rasagiline will be tested in this study as the MAO-B inhibitor. Rasagiline has been~     prescribed for many years to treat symptomatic Parkinson's disease. It is FDA approved for~     the treatment of Parkinson's disease but has not been shown to slow disease progression. The~     outcome and impact of this study will provide the first evaluation of MAO-B inhibitors at~     slowing the progression of the nigrostriatal pathway using advanced Magnetic Resonance~     Imaging (MRI) and functional Magnetic Resonance Imaging (fMRI) methods in PD.~   "
59436|NCT02788890|"~     The study will evaluate the vital signs changes during 3 different dental procedures~     performed for the same patient by the same dentist. The patients will be selected randomly~     and should all be healthy adults.~      The aim is to look for any significant changes in the major vital signs (heart rate,~     respiratory rate, blood pressure, peripheral capillary oxygen saturation (SpO2) and body~     temperature) during specified dental procedures (scaling, simple restoration, and simple~     exodontia) and compare the changes between the 3 procedures.~   "
59427|NCT02789007|"~     The main objective of this experiment is to assess the impact of parabolic flight on (1)~     spatial memory and orientation, (2) the changes in brain structure and function, and~     particularly the hippocampal formation, and (3) biochemical markers of stress and~     neuroplasticity.~      A preliminary study will be performed with the aims (1) to test during weightlessness~     hardware used to administer visuo-spatial testing and (2) to determine the optimal body~     posture for testing under microgravity conditions (i.e. body posture for which change in~     visuo-spatial testing induced by weightlessness is maximal).~      The main criteria are:~        -  Structural and functional changes of brain evaluated by fMRI;~        -  Cognitive performance, and specifically spatial cognition using a series computer-based~          tasks.~        -  Key neurotrophins determined in venous blood samples The criteria used in the~          preliminary experiment is visuo-spatial performance evaluated with a computer-based test~          assessing spatial cognition.~      The investigators hypothesize that hippocampal structure and function, and particularly the~     dentate gyrus, will be altered after parabolic flight compared to ground based controls.~     Specifically, the 3 tested hypotheses are:~        -  Parabolic flight induces changes in hippocampal structure;~        -  Weightlessness induces changes in cognitive performance, and specifically spatial~          cognition;~        -  There is a correlation between changes in hippocampal structure and changes in~          visuo-spatial memory performance.~        -  There is a correlation between changes in hippocampal structure and changes in key~          neurotrophins.~      The hypothesis tested during the preliminary experiment is that body posture affects the~     changes in spatial cognition performance.~   "
59428|NCT02788994|"~     This is a preliminary study to establish the issues and potential of the investigators~     proposed project, which involves recruitment of patients with and without dementia, who have~     been admitted to hospital following hip fractures. The study will be evaluating the result of~     treatment of unstable pertrochanteric hip fractures focusing on how soon mobility is restored~     leading to their independence. These patients would require surgical fixation (not~     replacement) of their hip fractures.~      The study will evaluate two methods of fixation of hip fractures treated with either a pin~     (nail) which is inserted within the cavity of the thigh bone or a hip screw with a plate~     which is applied on the outer aspect of the thigh bone.~      The data collected from this study will provide information on whether one method of fixation~     is better than the other.~   "
59429|NCT02788981|"~     This is a randomized, placebo-controlled, double-blind, phase II trial of nab-paclitaxel with~     or without mifepristone for advanced, glucocorticoid receptor-positive, triple-negative~     breast cancer. A total of 64 patients will receive nab-paclitaxel. Patients will be randomly~     assigned to either receive placebo or to receive mifepristone daily on the day prior to and~     day of each dose of nab-paclitaxel. Patients will be enrolled over 12 months and followed for~     12 months following completion of study.~      To expand and follow up on the investigators understanding of a potential pharmacokinetic~     (PK) interaction between nab-paclitaxel and mifepristone, investigators will perform PK~     studies in the first 20 patients enrolled at pre-specified PK sites.~   "
59430|NCT02788968|"~     The study to explore the development of these abilities with age, and called Development of~     the conflict detection during the reasoning - Decor will take place at CYCERON center and~     will include two groups of 22 participants: adolescents and young adults (N = 44). More~     specifically, this study aims to compare the changes in the brain of adolescents and young~     adults when conducting reasoning tasks for which there may be a cognitive conflict. Both~     groups of participants then spend an MRI (Magnetic Resonance Imaging) focused on the brain~     and in which they will carry out two classic tasks covering the main areas of reasoning~     (probabilistic and economic). Each of these tasks will be manipulated to include, or not, of~     making information call intuition to create or not a conflict between the correct answer~     (logic, normative) and biased response (intuitive, heuristic). Because of the major~     implication of this brain region in cognitive inhibition processes [of intuitive answer],~     measured brain activity in the anterior cingulate cortex (ACC) during both tasks version~     with or no conflict will be compared between groups. To better understand the links~     between the development of the CCA from adolescence to adulthood and conflict detection,~     activity measurements will be correlated with a part in morphometric measurements taken from~     the same area (volume Substance Grise - SG; characteristics of cortical sulci) and secondly~     to cognitive measures (executive functions - inhibitory control). This cross-sectional study~     focused on two age groups: 11-15 years and 19-25 years. For each age group, the participation~     of men / boys and women / girls will be balanced up.~   "
59431|NCT02788955|"~     This is a feasibility study to test the efficacy of diets of different amounts of protein and~     calories for patients with cancer. We hypothesize that nutritional deficits play a~     significant role in muscle loss and that nutritional therapy is an important first step in~     reversing or preventing muscle loss and maintaining/improving physical function, tolerance to~     treatment and quality of life.~   "
59432|NCT02788942|"~     Laparoscopic cholecystectomy is gold standard for gallstones. In this study the investigators~     are investigating the effect of the removing of cholecystectomy material from different~     ports, to the port site infections.~   "
59433|NCT02788929|"~     Design: Single center, prospective, randomized study that will compare activity levels in~     patients who complete cardiac rehabilitation after clinically indicated percutaneous coronary~     intervention with and without use of the wrist-worn Fitbit Charge HR device and mobile~     platform application.~      Primary Endpoint: The average number of steps taken per day will serve as the main marker of~     daily physical activity.~      Control: Patients who do not receive the device (Fitbit Charge HR).~      Secondary Endpoints: (1) change in daily energy expenditure (2) change in number of activity~     and sedentary bouts (3) change in sleep efficiency (4) change in weekly time of~     moderate/vigorous physical activity (5) change in quality of life (6) change in indicators of~     depression (7) change in medication adherence(8) change in HDL and LDL cholesterol (9) change~     in BMI and waist circumference (10) change in resting heart rate and blood pressure (11)~     change in exercise stress test performance (timeframe for all: baseline - 12 weeks)~   "
59434|NCT02788916|"~     The purpose of this study is to establish the distribution of peripheral T-cell lymphocyte~     (PTCL) subtypes by re-analysis and re-classification of samples according to the 2008 World~     Health Organization (WHO) classification of lymphoid neoplasms.~   "
59437|NCT02788877|"~     Efficacy of Treat-and-extend regimen (TER) using aflibercept in diabetic macular edema (DME)~     will be evaluated.~   "
59439|NCT02788851|"~     The purpose of this project is to evaluate the effectiveness of a structured aerobic exercise~     intervention for adults with Attention-Deficit/Hyperactivity Disorder (ADHD) with and without~     medication and compare it to medication alone. Participants will be randomly assigned to~     medication only + education, aerobic exercise intervention only, and combined aerobic~     exercise and medication groups. Participants will be evaluated at baseline, following~     medication optimization (for medicated groups), following 8 weeks of intervention, after 3~     months of follow-up, and after 6 months of follow-up. The investigators hypothesize that the~     combined group will have the best outcome at all evaluation points and that treatment gains~     will be maintained throughout the follow-up period if the assigned treatments are continued.~   "
59440|NCT02788838|"~     The purpose of this project is to examine the impact that television food advertisements have~     on brain responses and eating behavior in children. Food advertisements enhance children's~     liking and intake of foods that tend to be high in energy content and low in nutritional~     value. Although several studies have measured the differences in children's food intake after~     watching advertisements, none have shown the brain mechanisms associated with this change in~     behavior. In order to clarify the relationship between food advertising and eating behavior,~     the investigators have assembled a team with expertise in functional imaging, eating~     behaviors, and clinical pediatric research. First, the investigators will observe the~     differences in children's eating behaviors after being exposed to food commercials or~     non-food commercials. Second, the investigators will measure the difference in child brain~     response to high and low energy foods after being exposed to food commercials or non-food~     commercials. These data will allow us to identify which areas of the brain are specifically~     affected by exposure to food commercials and correlate activity in these areas with~     children's measured food intake in the laboratory. Forty children ages 7-9 will participate~     in this 5-visit study which will be completed over the course of 12 months. Understanding how~     food advertisements impact children's brain responses and subsequent eating behaviors will~     have implications for understanding why some children respond differently to these cues than~     others. These outcomes may also inform the development of more effective programs and~     policies to prevent childhood obesity.~   "
59441|NCT02788825|"~     Prostate cancer is a leading cause of cancer death among men in the Western world. Early~     detection of prostate cancer has been shown to decrease mortality, but has limitations with~     low specificity leading to unnecessary biopsies and over-diagnosis of low-risk cancers. The~     STHLM3 trial has paved the way for improved specificity in early detection of prostate cancer~     using the blood-based STHLM3 test for identifying men at increased risk of harbouring~     significant prostate cancer.~      Targeted prostate biopsies based on MRI images have been shown to increase sensitivity of~     high-grade cancers compared to the currently used systematic biopsies, but existing evidence~     are contradictory and not free from methodological flaws.~      The primary aim of STHLM3-MR/Fusion is to increase the specificity in early detection of~     prostate cancer without decreasing the sensitivity of aggressive prostate cancers by~     introducing targeted prostate biopsies and comparing to traditional prostate biopsies. The~     primary endpoints are the number of performed biopsies and the number of detected high-grade~     prostate cancers defined as Gleason 7 or higher. Secondary endpoints include the number of~     low risk prostate cancers diagnosed and the proportion of patients with up-or downgraded~     disease after assessment of prostatectomy specimen. Additional aims include to assess the~     health economic consequences of implementing MRI based prostate cancer diagnostics and to~     improve the quality and effectiveness of prostate cancer diagnosis in the routine health care~     in Stockholm.~      The STHLM3-MR/Fusion project will be performed in two separate phases, analyzed separately.~     Based on power calculations, approximately 500 planned for prostate biopsies will be included~     in the first phase. Men who have previously been diagnosed with prostate cancer may not take~     part in the study. The study period of Phase 1 is March 2016 to January 2017. The second~     phase will start in autumn 2016 and end by December 2017.~   "
59442|NCT02788812|"~     To determine if there is a difference in the quality of life in between patients who~     undergoes laparoscopic transabdominal pre-peritoneal (TAPP) or modified Lichtenstein~     hernioplasty~   "
59443|NCT02788799|"~     Along with symptoms of chest pain, the presence of ST segment elevations on ECG is the~     criterion usually used in practice to identify patients with acute coronary artery occlusion~     and is essential for the direct and acute referral of patients for primary PCI. However, ECG~     does not always reflect changes in the posterior wall of the heart, often equivalent to the~     left circumflex coronary artery's (LCX) supply area, resulting in an underrepresentation of~     LCX as culprit artery in STEMI populations. There is a general concern that some patients~     with genuine acute occlusion of LCX may present without ST segment elevation and be denied~     reperfusion therapy, resulting in larger infarction and worse outcome.~      The aim of this trial is to implement record of posterior ECG leads (V7, V8 and V9) in~     addition to the standard 12-lead ECG in the pre-hospital setting and to evaluate the clinical~     impact of this implementation: In comparison to a control cohort of STEMI patients diagnosed~     with a pre-hospital standard 12-lead ECG prior study start, the investigators hypothesize~     that introducing V7-V9 leads as a clinical routine in the pre-hospital setting will identify~     patients with STEMI involving LCX and with a non-diagnostic standard 12-lead ECG.~   "
59444|NCT02788786|"~     In Nepal, investigators are conducting a cohort study to estimate the relationship between~     signs of periodontal disease in pregnant women and preterm delivery. Within that cohort~     study, investigators plan to conduct an individually randomized trial of the acceptability~     and effect chlorhexidine, cetylpyridinium chloride, and salt water oral rinses on gingival~     crevicular fluid and plaque during pregnancy. Women for this pilot trial will be chosen from~     a subset of the area currently engaged in the larger cohort study, to simplify logistics. The~     pilot trial will have four arms (three oral rinse arms, and one control group).~        -  Arm 1: Twice daily oral rinse containing chlorhexidine 0.12% w/v (n=25 women with~          periodontitis~        -  Arm 2: Twice daily oral rinse with cetylpyridinium chloride (n=50; 25 women with/without~          periodontitis)~        -  Arm 3: Twice daily oral rinse with salt and water (n=50: 25 women with/without~          periodontitis)~        -  Arm 4: No oral rinse (n=50)~      To select and enroll these 175 participants, data collectors will use the information they~     collected during an oral health clinical examination conducted at the time of enrollment into~     the broader cohort study; this information will be used to classify women by signs of~     periodontitis.~      Those selected through this above process will be read an additional consent form; those~     agreeing to participate will be provided with a supply of their assigned rinse (and~     instructions on its use and handling/storage), or no rinse. Those in the three rinse groups~     will be asked to use the provided rinse twice per day after brushing and to save the empty~     bottles for collection by the health care worker. At the end of this first visit, women will~     additionally provide a venous blood sample to measure systemic inflammation markers and~     fluoride.~      Women receiving the rinse will be visited by study workers periodically to provide more oral~     rinse and check on their adherence to the rinse. All 175 women will be visited after 12 weeks~     to undergo a second oral health clinical examination and provide a second set of gingival~     crevicular fluid and plaque samples, to allow for evaluation of the effect of each of the~     oral rinses as compared to the normal physiological changes in gingival inflammation and~     biofilm composition during the course of pregnancy.~      At this final visit, the women in the three rinse arms will also answer a short questionnaire~     to gather feedback on acceptability and adherence to the oral rinse.~   "
59445|NCT02788773|"~     The purpose of this study is to find out the effects of giving durvalumab alone or in~     combination with tremelimumab on this type of cancer. In addition, this study will look at~     the side effects of durvalumab when given alone or in combination with tremelimumab.~   "
59659|NCT02785978|"~     Pre-QuantiPark is a pilot study to evaluate the reliability and responsiveness of ActiMyo~     measured activity in PD patients. The purpose of the study is to provide validation of the~     ActiMyo, an innovative home-recording device enabling use in clinical trials and as an~     innovative tool for PD patient care.~   "
59448|NCT02788734|"~     The purpose of this study is to learn about focal compressive median neuropathy at the wrist~     (Carpal Tunnel Syndrome) and outcomes of therapies (e.g. conservative and surgery) in the~     upper extremities of patients diagnosed with an inherited neuropathy. All patients enrolled~     in the Rare Diseases Clinical Research Network (RDCRN) Inherited Neuropathies Consortium~     (INC) Contact Registry who have marked one of the following disorders: CMT1A, CMT1B, CMT2A,~     CMT4, CMTX, other known CMT peripheral neuropathy, other unknown CMT peripheral neuropathy,~     or Hereditary Neuropathy with liability to Pressure Palsies (HNPP), will be invited via email~     to participate in this online study.~   "
59449|NCT02788721|"~     The study is a First-in-Human, Phase I, randomized, double-blind, placebo-controlled study~     evaluating single and multiple ascending oral doses of GLPG2451 and combined multiple doses~     of GLPG2451 and GLPG2222 in healthy female subjects. The purpose of the study is to evaluate~     safety and tolerability after single ascending oral doses and of multiple doses of GLPG2451~     given to healthy female subjects compared to placebo as well as of multiple doses of the~     combination of GLPG2451/GLPG2222 compared to GLPG2451/placebo.~   "
59450|NCT02788708|"~     This phase I trial studies the side effects and best dose of lenvatinib mesylate when given~     together with paclitaxel in treating patients with endometrial, ovarian, fallopian tube, or~     primary peritoneal cancer that has come back or grown. Lenvatinib mesylate may stop the~     growth of tumor cells by blocking a protein needed for cell growth and may block the growth~     of new blood vessels necessary for tumor growth. Drugs used in chemotherapy, such as~     paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Giving lenvatinib~     mesylate and paclitaxel together may work better in treating patients with endometrial,~     ovarian, fallopian tube, or primary peritoneal cancer.~   "
59451|NCT02788695|"~     A visual function focused add-on study to the Northern Ireland Cohort for the Longitudinal~     Study of Ageing (NICOLA). There are three key aims:~        1. Quantify age-related decline in a variety of visual functions within a populations based~          cohort.~        2. Explore the mechanisms underlying age-related visual impairments.~        3. Investigate how visual function impacts vision related quality of life.~   "
59452|NCT02788682|"~     Introduction: Vitamin D binding protein (VDBP) is a potential modulator of immune response~     and is associated with clinical progression of many diseases. Our aim is to assess influence~     of baseline 25-hydroxyvitamin D levels and VDBP single nucleotide polymorphisms (SNPs),~     rs4588 (C>A) and rs7041 (G>T), on baseline clinical parameters and response to interferon~     based therapy in chronic Hepatitis C patients in Egypt.~      Methodology: Genotyping will be performed by RFLP (Restriction Fragment Length Polymorphism)~     in treatment naïve Hepatitis C patients and healthy controls. Vitamin D levels will be~     assessed by ELISA. HCV RNA quantification will be performed by PCR to assess therapy outcome.~   "
59453|NCT02788669|"~     Colorectal cancer (CRC) is a major public health problem in France and worldwide. CRC is the~     third most common cancer in incidence and mortality in France. The vast majority of these~     cancers are adenocarcinomas that arise sporadically and develop from precursor lesions:~     adenoma. All CCR with the same disease stage do not have the same prognosis. Various~     parameters have been identified as factors influencing the prognosis and allows adjustment of~     the treatment. The poor histoprognostic factors are vessels and nerves invasion by the tumor~     or the mucinous adenocarcinoma subtype. At the molecular level, the presence of~     microsatellite instability (MSI) improves the prognosis, while the presence of a BRAF~     mutation is an independent poor prognostic factor.~      LRP-1 is a multifunctional endocytic receptor that belongs to the family of LDL receptors. It~     is involved in the clearance of matrix proteases. A loss of expression or a decrease of the~     LRP-1 activity is correlated with an increase of aggressiveness of cancer cells. This effect~     was demonstrated in vitro in vesicular thyroid carcinomas after LRP-1 blocking. The decrease~     in the immunohistochemical expression and LRP-1 genomic in hepatocellular carcinomas and lung~     adenocarcinomas was correlated with a decrease in the overall survival. In CRC, only one~     immunohistochemical expression study of LRP-1 in colonic adenocarcinoma has been published to~     date. This study shows that tumor cells express LRP-1, but in nearly half the cases, weaker~     than in normal colonic cells. The clinical and prognostic impact of LRP-1 expression in colon~     cancer and its association with a particular molecular or morphological profile has not been~     studied to date.~      In this work, the investigators will study the immunohistochemical and genic expression of~     LRP-1 in a series of colorectal cancers.~   "
59454|NCT02788656|"~     This pilot study will assess the impact of sacubitril/valsartan (trade name Entresto) on the~     elevated pulmonary artery pressures in patients with heart failure with reduced ejection~     fraction, measured using a previously implanted hemodynamic monitoring device (CardioMEMS).~   "
59455|NCT02788643|"~     Collagens are proteins present in all tissues. Besides their structural role, recent data~     showed that they were able to regulate many cellular functions. Many interactions occur~     between extracellular matrix macromolecules, especially collagen, and various cell types.~     These interactions can be controlled by peptides derived extracellular matrix macromolecules,~     called matrikines. Previous work from the investigators laboratory and others have shown that~     several C-terminal domain (NC1 domains) from basement membrane-associated collagens could~     regulate many cellular activities.~      Lung is an organ particularly abundant in basement membranes. It is likely that various lung~     diseases may affect metabolism of basement membrane associated collagens. To the~     investigators knowledge, no study has focused on the expression of collagen XIX α1 chain and~     collagen IV chains α3 and α4 chains in lung and studied possible variations of expression in~     various pathophysiological situations.~      The aim of this study are to:~        -  Study the presence of collagen IV and XIX (or fragments) in different types of sampling~          such as bronchoalveolar lavage, pulmonary aspiration and bronchial biopsies~        -  Evaluate quantitative variations of expression of these collagen in different pulmonary~          diseases, especially chronic obstructive bronchopneumopathy, infectious pneumonia,~          pneumonitis or lung cancer.~   "
59456|NCT02788630|"~     This study will evaluate the efficacy of an intervention to improve quality and duration of~     self-regulated nighttime sleep (the amount of time the child maintains a combination of~     uninterrupted sleep, quiet wakefulness, and re-initiation of sleep without parental~     intervention).~   "
59457|NCT02788617|"~     This prospective study will evaluate the efficacy of Diafert as an adjunct to morphological~     assessment in predicting embryos' potential to develop to the blastocyst stage on Day 5.~   "
59458|NCT02788604|"~     In Canada, approximately 1450 children are diagnosed with cancer annually. Diagnosis of~     childhood cancer and its aggressive treatment can have devastating psychosocial effects on~     the whole family (e.g. unpleasant feelings or emotions that impact your daily activities). It~     is not known whether health care providers who treat these children use and value~     psychosocial tools or how beneficial the use of these tools is for these families. This~     research team will test the benefits of using psychosocial screening on the quality of life~     of treated children, parents and siblings.~   "
59459|NCT02788591|"~     Primary Objective:~      Evaluate response to NERD treatment between patients with normal endomicroscopy findings~     compared with patients with abnormal endomicroscopy findings.~      Secondary Objectives:~      To evaluate the role of probe based endomicroscopy in the diagnosis of NERD by evaluating~     dilated intercellular spaces, evaluation of IPCL, and quantification of fluorescein leak.~      Quality of life at study entry and end of study. Compare two medications under study within~     each group as a subgroup analysis.~   "
59460|NCT02788578|"~     The objective of the PRELUDE study is to describe the use of lanreotide Autogel® (LAN ATG)~     combined with Peptide Receptor Radionuclide Therapy (PRRT) in the treatment of progressive~     neuroendocrine tumours located in the lung or in the digestive system as there is currently~     limited data on these treatments used together for these types of neuroendocrine tumours.~   "
59461|NCT02788565|"~     Data from this study will contribute additional knowledge regarding patient outcomes and~     direct somatostatin analogue (SSA) treatment related costs in clinical practice in the Nordic~     countries. Such knowledge can be of importance in a treatment decision, decision support for~     development of care, follow up and training of both patients and primary care nurses.~   "
59462|NCT02788552|"~     Wernicke-Korsakoff syndrome (WKS), once thought to be a rare condition, is now known to be~     common in people with nutritional deficiencies or alcohol dependence. The primary cause of~     WKS is thiamine deficiency, and more than 90% of cases are reported in alcohol dependent~     patients because alcohol dependence predisposes to severe nutritional deficiency. WKS may~     lead to significant, long-term brain dysfunction with severe effects on work, personal and~     social function. Whilst effective treatment may greatly reduce severe disability and the~     human and social costs of this illness, almost no evidence exists on optimal dosing regimens.~     This project proposes to develop quality evidence for effective treatment of WKS in an~     Aboriginal setting.~   "
59463|NCT02788539|"~     This project will work to increase knowledge about the utility of a website for management of~     chronic pain, Our Whole Lives (OWL). It will do so by examining barriers and facilitators to~     patient use. In order to gather this information, the investigators will conduct a Science~     Cafe with 30 individuals (including participants with chronic pain, who have family members~     with chronic pain or are a stakeholder in the chronic pain community) to gather feedback~     about how to tailor the OWL website to their needs and preferences and how to improve ease of~     use for this tool. The investigators will also pilot two cohorts with 40 patients with~     chronic pain (2 groups of 20 patients) with OWL, the patient-centered, mobile health chronic~     pain management resource, measuring pain impact (pain severity, pain interference, physical~     function) and pain associated outcomes (e.g., depression, anxiety, fatigue, sleep~     disturbance, ability to participate in social roles and activities, pain self-efficacy,~     health education impact and internalized stigma related to chronic pain).~   "
59464|NCT02788526|"~     Hepatocellular carcinoma (HCC) is the sixth most common malignancies worldwide and the second~     leading cause of cancer-related death. Surgical resection is still the main radical approach~     for HCC, but the recurrence rate after hepatectomy is very high, which hampers the further~     improvement of prognosis of HCC patients. The conventional risk factors of recurrence~     including: huge tumor, multiple lesions, vessels invasion and tumor rupture. Recently, the~     microvessels invasion (MVI) has been recognized a novel risk factor of recurrence after~     hepatectomy. The investigators' previous study showed that the recurrence rate is more than~     50% for the patients with >5cm solitary tumor and MVI. The MVI was confirmed as the only~     independent risk factor for the overall and disease-free survival of HCC patients in multiple~     variables analysis. It is important to reduce the recurrence and prolong the survival of~     patients after hepatectomy with effective adjuvant therapy. TACE has been utilized as an~     adjuvant therapy after hepatectomy, but its significance is still unknown. Then, the~     investigators design the current prospective randomized clinical trial to evaluate the effect~     of adjuvant TACE to reduce the recurrence in HCC patients at high risk (>5cm solitary tumor~     and MVI) after resection, compared to vigilant follow-up.~   "
59465|NCT02788513|"~     The study is designed to compare the effects of BI 425809 compared to placebo in patients~     with cognitive impairment due to Alzheimer's Disease.~   "
59466|NCT02788500|"~     The overall aim of this project is to gain an in-depth understanding of the epidemiology of~     sports-related injuries and illnesses in parasport in order to assist the identification and~     development of specific injury prevention strategies adapted to parasport.~   "
59467|NCT02788487|"~     The objectives of this study is to compare short-term outcomes of CPAP and TRD in the~     treatment of obstructive sleep apnea. Study design is a randomized cross-over trial during~     3-weeks period of each treatment in 36 patients. Primary outcomes are quality of life, degree~     of sleepiness, and severity of OSA determined by FOSQ ESS, and AHI or RDI, respectively.~   "
59468|NCT02788474|"~     Identifying biomarkers to predict the clinical course and benefits of therapy early in the~     course of the disease remains one of the most urgent and relevant challenges to improve~     overall patient management, to prevent treatment delay or overtreatment. This study is~     conducted to examine the effect of nintedanib treatment on change in biomarkers indicative of~     extracellular matrix turnover which have been shown recently to correlate with disease~     progression. This study further aims to confirm the association of biomarker course during~     the first three months of treatment and disease progression.~   "
59469|NCT02788461|"~     A randomized phase II trial to assess the efficacy and safety of selective metabolically~     adaptive radiation dose escalation in locally advanced non-small cell lung cancer receiving~     definitive chemoradiotherapy. Eligible and consenting patients will be randomized to receive~     conventional chemoradiotherapy or chemoradiotherapy with a radiation (RT) integrated boost.~     All patients will receive a fludeoxyglucose-positron emission tomography (FDG-PET) scan~     within two weeks prior to starting treatment. The primary outcome is to determine if dose~     escalation to metabolically active tumor subvolumes will reduce local-regional failure rate~     at 2 years.~   "
59470|NCT02788448|"~     The purpose of this Clinical Investigation is to validate that the clinical use of the~     VIVASURE CLOSURE DEVICE™ is safe for the operator, patient and third parties, and to confirm~     its performance to percutaneously close femoral arterial puncture sites in the range of 18-24~     F, post endovascular procedures.~      This is a non-inferiority study based on safety. Safety will be assessed by incidence and~     severity of major complication rates directly related to the VIVASURE CLOSURE DEVICE up to 3~     months from implantation is no worse than those associated with cut-down and sutured close.~   "
59471|NCT02788435|"~     Patients undergoing vocal cord surgery (phonosurgery) are often prescribed voice rest~     postoperatively. However, no clinical trials have ever been conducted to ascertain the~     efficacy of using voice rest and its impact on functional voice outcomes. The purpose of this~     randomized-clinical trial is to determine if the prescription of voice rest has an impact on~     voice outcomes following phonosurgery.~   "
59472|NCT02788422|"~     Thorough, understandable discharge instructions empower caregivers, allowing them to provide~     optimum care of their children during illness. Unfortunately discharge instructions are often~     incomplete and difficult to understand. The use of video discharge instructions has been~     shown to increase patient understanding of their illness. The investigators would like to~     know if using video discharge instructions for caregivers of children with middle ear~     infections helps to better understand how to take care of children at home, potentially~     allowing the child to feel better faster. The investigators will be comparing video discharge~     instructions to a paper handout to see if the former leads to improved well-being of the~     child and improved caregiver knowledge, satisfaction and anxiety.~   "
59473|NCT02788409|"~     This study is conducted to estimate population-based incidence rates of second primary~     malignancies among patients with CRPC similar to those treated with Xofigo. These rates will~     provide context for second primary malignancy incidence rates from the REASSURE study.~      Furthermore this study aims to provide further information about the documentation of bone~     metastases in Medicare data and the extent of use of only oral androgen deprivation drugs~     among patients with Medicare Part D coverage, as well as to estimate overall survival of the~     study population.~   "
59474|NCT02788396|"~     This study aims to assess the impact of NC balloon post-dilatation on coronary~     microcirculation in patients with ST segment elevation myocardial infarction (STEMI)~     undergoing primary percutaneous coronary intervention (PPCI).~   "
59475|NCT02788383|"~     Actually, our center is doing the prenatal determination of RhD fetal genotype in all RhD~     negative pregnant women.~      The investigator want to demonstrate that this is an useful and efficient method.~   "
59476|NCT02788370|"~     Aim of this study is to compare cardiopulmonary response to conical-PEP breathing during~     exercise in older people.~   "
59477|NCT02788357|"~     This proposal evaluates the safety and effectiveness of a noradrenergic drug named~     atomoxetine combined with motor training to enhance cortical plasticity and improve hand~     function after stroke.~   "
59478|NCT02788344|"~     This is a multicenter multidisciplinary study designed to investigate patient, provider, and~     system-related factors that are associated with the quality and safety of initial management~     for suspected ST-segment elevation myocardial infarction (STEMI) evolving for less than 12~     hours in daily practice. The primary hypotheses are that delayed reperfusion therapy for~     suspected STEMI independently relates to provider practice patterns and system barriers. It~     is further postulated that non-compliance with target delays in implementing percutaneous~     coronary intervention (PCI) or fibrinolytic therapy is associated with worse in-hospital~     clinical outcomes. The secondary hypotheses are that the delivery of acute reperfusion~     therapy within target delays is associated with increased rates of false-positive cardiac~     catheterization laboratory activation, inadvertent fibrinolytic therapy, and bleeding events.~      The project will be conducted in three emergency medical services and 23 public and private~     (for-profit and non-for-profit) acute care hospitals in Northern Alps in France. Data over~     the index hospital stay period will be retrospectively collected for all the patients~     included in an ongoing prospective regional hospital-based clinical registry of suspected~     STEMI from October, 1st, 2002 to December, 31, 2014. Inclusion of 7435 patients is~     anticipated.~      In this observational retrospective study, no specific intervention is assigned to~     participants. All diagnostic testing, procedures, and medication ordering are performed at~     the discretion of attending physicians. No enrollment or follow-up visits are planned.~      The primary effectiveness outcome is timely acute reperfusion therapy. The secondary~     effectiveness outcomes include false-positive cardiac catheterization laboratory activation~     for catheterization candidates and inadvertent fibrinolytic therapy. The secondary medical~     outcomes include in-hospital all-cause mortality, major adverse cardiovascular events, and~     major bleeding events. Multivariable logistic regression model will be developed to identify~     baseline characteristics that are independently associated with timely acute reperfusion~     therapy. Propensity score analysis will be performed for comparing clinical outcomes between~     timely acute reperfusion therapy recipients and non-recipients.~   "
59479|NCT02788331|"~     The explanatory mechanism of the relationship between the volume of surgical procedures~     performed by individual hospitals and the occurrence of serious adverse events is not clear.~     Based on the  practice makes perfect  dogma, we will explore whether a learning effect can~     explain the volume-outcome relationship for complex surgical procedures using a nationwide~     dataset. Especially, we assume that increasing volume of procedures over time may be~     associated with improved outcomes.~   "
59480|NCT02788318|"~     The mortality rate is increased in patients with epilepsy, and especially among patients with~     drug-resistant epilepsy. This increased mortality is mainly related to the risk of SUDEP~     whose incidence is between 3.5 and 9 per 1,000 for patients with drug-resistant epilepsy. The~     term SUDEP refers to a sudden death occurring in a patient with epilepsy in whom anamnestic~     and post-mortem evidence does not identify a particular cause. Experimental and clinical data~     strongly suggest that most of SUDEP result from a postictal respiratory dysfunction~     progressing to terminal apnea. Due to the major role of serotonin in regulating breathing~     rhythms and data in animal models of epilepsy, it is envisaged that an alteration of~     serotonergic systems of the brainstem and limbic regions may play a central role in the~     occurrence of SUDEP. The objective of this work is to look for abnormalities of the~     serotonergic transmission within regulatory regions of respiratory and autonomic functions in~     brain samples prospectively collected in patients died from SUDEP.~   "
59481|NCT02788305|"~     This study investigate the progression of labour in 144 normal weight pregnant women (BMI~     <30) and 144 obese pregnant women (BMI >30) , not in labor admitted for induction of labor.~     These women are to be investigated for success of induction of labor.~   "
59482|NCT02788292|"~     A single-centre triple-blind study looking at the addition of NAC to tumescent solution for~     liposuction and fat grafting in healthy patient volunteers already undergoing bilateral~     breast reduction. Three-dimensional reconstructions and volumetric analysis will be performed~     based on CT scans at 0, 1 and 3 months and then histological analysis will be performed after~     fat graft explantation at 3 months to determine fat graft vascularity and quality.~   "
59483|NCT02788279|"~     This is a Phase III, multicenter, open-label, three-arm, randomized study in participants~     with unresectable locally advanced or metastatic colorectal cancer (CRC) who have received at~     least two prior regimens of cytotoxic chemotherapy for metastatic disease. The study compares~     regorafenib, a standard of care therapy in this setting, to cobimetinib plus atezolizumab and~     atezolizumab monotherapy.~   "
59484|NCT02788266|"~     Background: The aim of this study was to evaluate the treatment of multiple gingival~     recessions associated with non-carious cervical lesions (NCCL) using a modified coronally~     advanced flap in combination with a sub-epithelial connective tissue graft (SCTG) on restored~     root surfaces.~      Methods: Twenty-three systemically healthy subjects, who were positive for the presence of~     three cervical lesions associated with gingival recessions in three different adjacent teeth,~     were enrolled in the study. The NCCL were each restored prior to surgery by using one of~     three different materials: composite resin (group 1), resin-modified glass ionomer cement~     (group 2) or giomer (group 3). The defects were treated with SCTG. Clinical measurements,~     including plaque index (PI), bleeding on probing (BOP), relative recession height (rRH),~     probing depth (PD), cervical lesion height (CLH), relative clinical attachment level (rCAL),~     keratinized tissue height (KTH), keratinized tissue thickness (KTT), percentage of root~     coverage (RC), and percentage of cervical lesion height coverage (CLHC) were recorded at~     baseline, 3 and 6 months, and 1 year postoperatively.~   "
59485|NCT02788253|"~     Mallampati score (classification of the visibility of oropharyngeal structures) should be~     performed in the sitting position, head in the neutral position, mouth widely open, and~     tongue protrudes, without phonation. However, phonation, and position modify the visibility~     of oropharyngeal structures and thus the Mallampati score. Furthermore, some patients cannot~     be evaluated in sitting position because (emergency, fractures, pain, supine position require~     for medical or surgical pathology...).~      We aimed at evaluating the predictive value of the best observable Mallampati score as~     compare to the recommended Mallampati score.~   "
59486|NCT02788240|"~     All consecutive ACLF (Acute on Chronic Liver failure) patients presenting to the institute of~     liver and biliary sciences, irrespective of the etiology , who have survived the acute phase~     (i.e. 90 days of onset of the acute on chronic liver failure) and who are willing to~     participate in the study would be enrolled. After performing baseline biochemical tests,~     patients will undergo transjugular liver biopsy (TJLB), HVPG (Hepatic Venous Pressure~     Gradient), Circulating CD34 cells, Bone marrow aspiration and biopsy (Histopathological and~     immunohistochemical examination will be done).~   "
59487|NCT02788227|"~     Background:~      The Ebola virus causes a severe disease. It can be fatal. The usual incubation period after~     being exposed is 2 to 21 days. There is no approved treatment for Ebola infection. There is~     also no vaccine to prevent infection either before or after exposure. Researchers want to~     test an Ebola vaccine. They want to give it to people before they are exposed to the virus in~     order to prevent the disease.~      Objectives:~      To see how long-lasting and effective the vaccine rVSV[delta]G ZEBOV-GP (V920) is at~     preventing Ebola.~      Eligibility:~      Healthy adults at risk of exposure to the Ebola virus at work through lab or clinical~     contact.~      Design:~      Participants will be screened with medical history, physical exam, and blood tests.~      Participants will get the study vaccine. It will be injected into their upper arm.~      Participants will be monitored closely for at least 30 minutes. They will get a diary card to~     record any symptoms they have from the vaccine for up to 14 days.~      Participants will have study visits at 1, 3, and 6 months after they get the vaccine, then~     every 6 months (that is, at months 12, 18, 19, 24, 30, and 36 of study) for a total of 36~     months.~      Eighteen months after they join the study, participants will be randomly assigned to one of~     two groups. One group will get a second (or booster ) dose of the vaccine. The other group~     will not get a second dose.~      This study lasts 36 months.~   "
59488|NCT02788214|"~     Helicobacter pylori is a common bacterial infection. It can lead to severe stomach problems~     or stomach cancer. Researchers want to look at samples of the bacteria. These will be taken~     from chronically infected people. They want to identify the genetic differences in H. pylori~     strains. This could help predict which people who get infected with the bacteria will get~     cancer. This could lead to the cancer being detected earlier. It could also mean less people~     get stomach cancer.~      Objectives:~      To study genetic variations of H. pylori strains based on samples from chronically infected~     people. To identify the features of strains that might lead to severe stomach problems or~     stomach cancer.~      Eligibility:~      People ages 35 70 who need an upper endoscopy or who were recently diagnosed with stomach~     cancer~      Design:~      Participants will be screened by the doctor who does their procedure and a study nurse.~      Participants who have endoscopy will have 6 biopsies removed. These are tissue samples. They~     are about the size of a grain of rice. Participants will allow the study team to access~     reports from their stomach exam.~      Participants with stomach cancer will donate some of the tissue that will be removed during~     their clinical care. They will allow the study team to access reports of their surgery. They~     will also allow them to access the microscope slides of their stomach.~   "
59496|NCT02788110|"~     Background:~      Non-invasive forms of respiratory support have been developed to manage respiratory distress~     and failure in premature newborns without exposing them to the risks associated with invasive~     mechanical ventilation. It has been difficult to synchronize non-invasive ventilation due to~     the large air leaks, high respiratory rates, and small tidal volumes inherent to this~     interface and population. Neurally adjusted ventilatory assist (NAVA) is a novel mode of~     ventilation that uses a functional naso/orogastric tube with embedded electrodes which detect~     diaphragmatic contractions (called the Edi signal). NAVA uses this Edi signal to synchronize~     ventilator support to the patient's own respiratory efforts and to support these efforts as~     needed. Few studies have examined the use of NAVA with non-invasive ventilation (NIV) in~     preterm neonates. A group at Arkansas Children's Hospital recently completed a study, looking~     at work of breathing in an animal model comparing NIV NAVA with the unsynchronized nasal~     intermittent positive pressure (NIPPV) mode currently used at this hospital. They were able~     to show that work of breathing was lower with NAVA in this model. This study will take what~     was shown in the animal model and translate this to the bedside. Using respiratory inductance~     plethysmography to measure thoracoabdominal asynchrony, this study will compare work of~     breathing during NIPPV versus NIV NAVA in preterm neonates with respiratory insufficiency.~      Hypothesis:~      Work of breathing as estimated by the phase angle (θ) using respiratory inductance~     plethysmography will be decreased with the use of NIV NAVA in comparison to unsynchronized~     NIPPV in premature neonates with respiratory insufficiency.~      Methods:~      Fifteen premature neonates of between 1-2 kilograms' current weight, with gestational age at~     birth between 24-34 weeks, and receiving non-invasive ventilation will be enrolled in the~     study after consent is obtained. The infants will be ventilated using NIV NAVA and NIPPV~     applied in random order for 15 minutes each while using respiratory inductance~     plethysmography to measure thoracoabdominal asynchrony as an estimate of work of breathing.~      Significance:~      This study will identify whether or not NIV NAVA has advantages over NIPPV for improving work~     of breathing in premature neonates.~   "
59489|NCT02788201|"~     Background:~      Advanced urothelial cancer has no cure. But only a few chemotherapy drugs have been tested~     for it. The Co-eXpression ExtrapolatioN (COXEN) model predicts if cells respond to treatment.~     It may also help determine which drugs fight urothelial cancer based on the characteristics~     of a tumor. Researchers want to test if this model can choose the best therapy for advanced~     urothelial cancer within 3 weeks and how tumors respond to the next best therapy.~      Objective:~      To test if the COXEN model can choose the best therapy for advanced urothelial cancer within~     3 weeks.~      Eligibility:~      People ages 18 and older whose urothelial cancer has spread after at least 1 line of~     chemotherapy~      Design:~      Participants will be screened with medical history, physical exam, blood and urine tests, and~     tumor scans.~      Participants will provide a tumor sample from a previous surgery and a new biopsy. A needle~     will remove a small piece of tumor.~      Participants will repeat screening tests, plus have an EKG and scan. For the scan, they will~     get an injection of radioactive drug. They will lie in a machine that takes pictures.~      Participants will take the drugs assigned by the COXEN model. They will have visits every 2 3~     weeks. These will include blood and urine tests.~      Participants will have tumor scans every 8 9 weeks.~      Participants may have another biopsy.~      Participants will take the drugs until they can t tolerate the side effects or their cancer~     worsens. They may be assigned to a second COXEN therapy.~      Participants will have a follow-up visit 4 5 weeks after their last drug dose.~      Participants will be contacted by phone every few months until death.~   "
59490|NCT02788188|"~     Background:~      Middle East Respiratory Syndrome (MERS) is a newly discovered contagious and sometimes fatal~     respiratory virus. People often get MERS through close contact with an infected person.~     Scientists are worried that MERS may spread and cause more infections. There are no vaccines~     or treatments for MERS right now. Researchers think a new therapy called SAB-301 may be able~     to help. Antibodies are proteins the body makes to attack viruses. SAB-301 is made of~     antibodies made in cows to fight MERS. The antibodies are collected from plasma, the liquid~     part of cow blood.~      Objective:~      To evaluate the safety and tolerability of SAB-301 in healthy adults.~      Eligibility:~      Healthy people ages 18 60 who:~      Do not have chronic medical problems~      Do not take any medications (exceptions are acetaminophen, ibuprofen, vitamins, seasonal~     allergy meds and oral contraception)~      Do not have allergies to beef products~      Agree to use two forms of contraception while on study (both men and women)~      Design:~      Participants will be screened with:~      Medical history~      Physical examination~      Blood and urine tests~      Participants will have a return visit.~      They will have a physical exam and blood tests.~      They will be randomly assigned to receive either SAB-301 or a placebo which is given by~     infusion~      through an arm vein over 1 3 hours.~      They will be monitored at the clinic for 6 hours after the infusion. They will have~     additional blood draws.~      Participants will have 2-hour visits 1, 3, 7, 21, 42, and 90 days after the infusion. At each~     visit they will be evaluated and have blood and urine tests.~   "
59491|NCT02788175|"~     Background:~      In most people infected with human immunodeficiency virus (HIV), their immune system cannot~     control HIV infection. They need drugs called combination antiretroviral therapy (cART) to~     control the HIV. When people stop cART treatment, their immune system cannot control the~     infection again. They can also become resistant to cART and have lasting side effects.~     Researchers want to test if the drug vedolizumab is effective at controlling HIV infection~     without the need for cART.~      Objective:~      To teste if vedolizumab is safe and can control the amount of HIV in the blood when cART is~     not taken.~      Eligibility:~      People ages 18-65 who have HIV and are being treated with cART~      Design:~      Participants will be screened with:~      Physical exam~      Medical history~      Electrocardiogram: Soft, sticky patches on the chest, arms, and legs measure heart activity.~      Blood and urine tests~      Participants will have a baseline visit. This will be 2-5 hours each day for 1-2 days. It~     will include repeats of the screening tests and:~      Leukapheresis: Blood is removed through a needle in the arm. A machine separates the white~     blood cells from the blood. The rest of the blood is returned to the participant.~      Neurologic exam: The nerves and reflexes are tested.~      First vedolizumab infusion through an arm vein~      Participants will have visits every 4 weeks for 30 weeks. These will include:~      Vedolizumab infusions~      Repeats of baseline tests~      Participants will have more visits for blood draws.~      Participants will keep taking cART until after the week 22 infusion.~      After discontinuing cART at study week 22, participants will be seen every two weeks to~     monitor the CD4 count and the level of HIV in the blood. Some of these visits will occur in~     between infusion visits and will only take about 1 hour to complete. cART will be restarted~     if a participant s HIV levels go up to high, or if their CD4 cell counts decreases by too~     much.~      For the follow-up phase, participants will have visits every 4 weeks for 24 weeks. These will~     include blood tests and a physical exam.~   "
59492|NCT02788162|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
59493|NCT02788149|"~     To investigate the accuracy of neck ultrasound in identifying and discriminating the severity~     of obstructive sleep apnea (OSA).~      Primary objective: To test the hypothesis that ultrasound can be used as a reliable tool for~     identifying the anatomic characteristics and dynamic changes of pharyngeal airspace in~     patients with OSA.~      Secondary objective: Investigate if ultrasound can be used to discriminate OSA severity.~      The investigators will compare these results to the results from polysomnography study.~   "
59494|NCT02788136|"~     The study design included six visits. During the first visit (visit 0), the subjects~     underwent physical examination(height, weight, body mass index (BMI), arm span, and upper~     segment measurement) and testicular ultrasound (US) for the calculation of testicular volume.~     At 0800 h of day 0, all subjects provided a basal blood sample immediately followed by a~     single intramuscular injection of hCG of 5000 IU. Further five visits were performed each of~     five following consecutive days after the hCG injection. A blood sample was taken at each~     visit after an overnight fast~   "
59495|NCT02788123|"~     The main purpose of this study is to evaluate clinical efficacy of bismuth tripotassium~     dicitrate (De-Nol) in combination with pantoprazole versus pantoprazole monotherapy in~     subjects with NSAID-induced gastropathy in 14±2 days of treatment.~   "
59497|NCT02788097|"~     In recent artificial frozen embryo transfers (FET) in which blastocysts vitrified on day 4 of~     culture and transferred on P+4, with blastocysts traditionally transferred on P+5, a high~     rate of implantation has been observed. In addition, a greater number of these implantations~     resulted in clinical pregnancies (i.e., a conceptus with normal fetal heart activity). In~     this prospective randomised control study, the investigators will investigate whether this~     increased viability, is due either to embryo quality, endometrial receptivity, or a~     combination of the two factors by randomizing the transfer of day 5 blastocysts to P+4 or~     P+5.~   "
59660|NCT02785965|"~     The purpose of this study is to determine whether the use of electroacupuncture to dredge and~     regulate Dai Meridian combined with lifestyle modification are more effective than lifestyle~     modification only in the treatment of anovulation and hyperandrogenism due to polycystic~     ovary syndrome (PCOS) with abdominal obesity.Two thirds of participants will receive~     electroacupuncture and lifestyle modification in combination, while the other one third will~     receive lifestyle modification only.~   "
59498|NCT02788084|"~     1. Develop a Next-Generation Sequencing (NGS) workflow for mutation profiling of~          formalin-fixed paraffin-embedded (FFPE) tissue and cell-free DNA (cfDNA) specimens.~        2. Calculate the proportion of cases in a test series of B-cell non-Hodgkin Lymphomas~          (BNHL) with somatic mutations or immunoglobulin heavy chain (IGH) gene rearrangements~          common to both FPPE and cfDNA specimens.~        3. Determine if certain types of BNHL are more likely to have mutation profiles common to~          both FFPE & corresponding cfDNA (FFPE-cfDNA dyads)~        4. Determine if specific mutations or mutation profiles in FFPE or cfDNA specimens (or~          both) are of prognostic value after a clinical follow-up of 2 years from the time of~          diagnosis.~   "
59499|NCT02788071|"~     The purpose of this study is to investigate if fecal microbiota transplantation (FMT) will~     result in improvement in clinical outcome in patients with irritable bowel syndrome (IBS).~   "
59500|NCT02788058|"~     To evaluate the efficacy and toxicity of patients treated with hypofractionated radiotherapy~     for limited metastatic NSCLC harboring sensitizing EGFR mutations after first line TKI~     therapy. An exploratory biomarker analysis in blood and tumor samples is also planned.~   "
59501|NCT02788045|"~     The purpose of this study is to assess the safety/tolerability of the 2 different vaccine~     regimens of priming with trivalent Ad26.Mos.HIV and boosting with trivalent Ad26.Mos.HIV and~     Clade C gp140 plus adjuvant or priming with tetravalent Ad26.Mos4.HIV and boosting with~     Ad26.Mos4.HIV and Clade C glycoprotein (gp)140 plus adjuvant. Immune responses of the~     different vaccine schedules will be assessed.~   "
59502|NCT02788032|"~     This open-label, prospective, controlled intervention study involves evaluating tolerance and~     acceptability of an Oral Nutrition Supplement (ONS; EnergieShake®) in 16 adult patients who~     are already taking an ONS. Following a 2-day baseline data collection on their current ONS,~     patients switch to the test ONS, which is taken for a further 8 consecutive days. Patients~     revert to their current ONS at the end of the study. Patients act as their own controls and~     thus all patients are allocated the same intervention.~      Daily records of GI tolerance and compliance with the prescribed amount of ONS will be kept~     for participants throughout the study period. Participants' height and weight will be~     collected at baseline (weight at end will also be collected), all medications will be~     documented, and relevant medical and dietary histories will be recorded. A questionnaire at~     the end of the intervention period will be administered collecting participants' views on the~     acceptability (taste and palatability) of the test ONS. Taste and palatability will be~     assessed via a questionnaire that uses a Hedonic scale to quantify preference.~   "
59503|NCT02788019|"~     This is a randomized noninferiority interventional study to determine the equivalence of two~     adductor canal block (ACB) methods: mid-thigh and distal thigh in patients undergoing medial~     foot, medial ankle, or medial leg surgery. Sixty eight patients will be identified during~     their orthopedic presurgical clinic visit, anesthesia preoperative clinic visit or Day~     Surgery Unit (Zale Lipshy Hospital, Clements University Hospital, and UTSW Outpatient Surgery~     Center) for eligibility. Eligible individuals may be introduced to the study in the~     orthopedic presurgical clinic or the anesthesia preoperative clinic by staff. After consent~     patients will be randomized (break-seal method) to receive either a mid-thigh or distal thigh~     block using ropivacaine prior to foot, ankle, or leg surgery. The following measurements will~     be obtained to determine the change in sensory distribution: pinprick test with Neuropen,~     maximum voluntary isometric contraction before and after block, postoperative pain scores (24~     hrs and at discharge) and postoperative opiate consumption.~   "
59504|NCT02788006|"~     Multicenter prospective phase II study evaluating regorafenib in older patients with~     metastatic colorectal cancer~   "
59505|NCT02787993|"~     The purpose of this study is to conduct a pilot randomized controlled trial (RCT) to examine~     the feasibility, acceptability, and cultural sensitivity of a cross-cultural cognitive~     behavioral therapy (CBT) multi-symptom management protocol targeting distress (anxiety,~     depression), pain, and fatigue in women with advanced stage breast cancer in Singapore and~     the US.~   "
59506|NCT02787980|"~     Compare serum tryptase levels of premature babies (<37 weeks of amenorrhea) to children born~     at full term.~      Study the evolution of serum tryptase levels in premature babies(<37 weeks of amenorrhea).~     Study the relationship between the onset of infectious complications, mainly the type of~     necrotizing enterocolitis seen in premature babies (<37 weeks of amenorrhea) and the~     evolution profile of serum tryptase levels.~   "
59507|NCT02787967|"~     The study will be conducted in asthmatic children aged 5 to 11 years and is based on a~     single-dose, open-label, randomized, 2-way cross-over design where a Dry Powder Inhaler (DPI)~     fixed combination of beclometasone dipropionate (BDP) 35 μg plus formoterol fumarate (FF) 4~     μg is compared with the free combination of licensed BDP DPI and FF DPI~   "
59508|NCT02787954|"~     The purpose of this study is to determine if MRI imaging can detect genetic, proteomic, and~     metabolomic characteristics of liver tumors. The study also aims to determine if these~     imaging characteristics are correlated with clinical outcomes.~   "
59509|NCT02787941|"~     Adherence to treatment in post-acute coronary syndrome patients has been found to be poor in~     several studies. Pharmacists play a significant role in enhancing medication adherence and~     reducing rates of mortality and re-admission to hospital by performing medication~     reconciliation and tailoring, and patient education. The purpose of this study is to~     determine the effect of pharmacist-delivered multifaceted intervention on medication~     adherence and clinical outcomes of post-acute coronary syndrome patients. The study will be~     designed as a randomised controlled trial with blinded outcome assessors. The population~     includes patients who survive during hospitalisation with discharge diagnosis of acute~     coronary syndrome. Pharmacist-delivered multifaceted intervention consists of two counselling~     sessions within 1 week before and after hospital discharge including medication~     reconciliation and tailoring, and support with pill organiser and drug information leaflet.~     Primary outcome measure is the proportion of patients adherent to medication at 1 month after~     discharge. Secondary outcome measures are the proportions of patients (1) adherent to~     medication at 3 months after discharge, (2) readmitted to hospital and (3) dying within 3~     months after discharge. The investigators also measure (4) the change in quality of life and~     (5) beliefs about medicines from baseline at 3 months.~   "
60385|NCT02776462|"~     The purpose of this study is to determine the sensitivity and specificity of an aid in~     assessment of concussion based on eye-tracking, in comparison to a clinical reference~     standard appropriate for the Emergency Department (ED).~   "
59510|NCT02787928|"~     In the United States the incidence of cesarean deliveries have increased over the last~     several decades and is currently approximately 30% nationwide. The anesthesia and analgesia~     for elective c-sections vary between institutions.~      Parturients present a unique challenge for the anesthesiologist as the mother has to care not~     only for herself, but also for the newborn postpartum. While intrathecal opioids provide~     adequate pain relief, they do so at the cost of bothersome side effects for patients, such as~     pruritus and nausea/vomiting.~      Intrathecal hydromorphone has started to be explored as a new option for intrathecal~     analgesia. A study done by Beatty et al. showed in a retrospective review that 40 mcg of~     intrathecal dilaudid was safe and effective as compared to intrathecal morphine for analgesia~     after cesarean delivery. Additionally they showed no difference in side effect profiles of~     the two medications. Mhyre et al. investigated the use of 100 mcg of intrathecal dilaudid~     with hyperbaric bupivacaine in varying dosages for labor analgesia. The results were~     inconclusive, but the dosage of hydromorphone was reported to be without adverse effects.~      Virginia Commonwealth University Health Systems has successfully instituted the use of~     intrathecal morphine with superior analgesia but with undesired side effects, most notably~     pruritus. Recent drug shortages of duramorph have prompted investigators to seek alternative~     options for post cesarean section analgesia. The investigators are interested in determining~     the dose, efficacy, and side effect profile of intrathecal hydromorphone. Although our~     institution has never utilized intrathecal hydromorphone for our patient population, it has~     been studied at various other institutions where it has been found to be safe and efficacious~     with an acceptable side effect profile.~   "
59511|NCT02787915|"~     This trial is to evaluate the safety and effectiveness of autologous type-1 polarized~     dendritic cell vaccines (patients' autologous DC1s loaded with multiple antigens CTL epitope~     peptide complexes), after radical resection for patients with stage III-IV renal cell~     carcinoma. Autologous cytotoxic of T lymphocytes (CTL) induced by type-1 polarized dendritic~     cells (DC1) loaded with MAGE-3/MAGE-4/survivin/ her2 /COX-2 CTL epitope peptides .~   "
59512|NCT02787902|"~     The purpose of this study is to develop, implement, and evaluate a behavioral weight~     management intervention with a communication training component for Mexican-American women.~     The study has three specific aims.~      Aim 1: Develop a behavioral weight loss intervention that modifies evidence-based behavioral~     weight loss treatment using results from formative data collected from Mexican-American~     mother-daughter dyads. The adapted intervention will focus on improving dyadic communication~     and collaboration for providing reciprocal support for healthy eating and physical activity~     behaviors.~      Aim 2: Implement and evaluate a pilot weight management program adapted for mother-daughter~     dyads. Dyads will be randomly assigned to partner-based treatment with or without~     communication skills training.~      Aim 3: Evaluate associations between changes in weight, weight-related behaviors, and~     psychosocial variables with changes in measures assessing interpersonal communication.~   "
59513|NCT02787889|"~     The investigators determined effects of 8-week dietary protein intake in mixed meals with~     uneven or even consumption pattern on the metabolic outcomes of whole-body net protein~     synthesis and muscle protein synthesis in older participants.~   "
59514|NCT02787876|"~     To evaluate the efficacy and safety of pegteograstim on chemotherapy-induced neutropenia in~     children with solid tumors~   "
59515|NCT02787863|"~     Goal: to to examine the formation of postvaccination immunity and evaluate the therapeutic~     effect of bacterial vaccines in patients with inflammation diseases of bronchopulmonary~     system. Objectives of the study: assessment of microbiocenosis mucous membranes of the upper~     respiratory tract in patients with bronchopulmonary pathology before and after use of~     bacterial vaccines. Identification of mayor lymphocytes subpopulations, proinflammatory~     cytokines, inflammatory markers in patients in the dynamics of the vaccination process. Study~     the profile of humoral immune response in patients under different schemes of vaccination.~     Detection of levels of autoantibodies against tissue antigens in the sera of vaccinated~     patients with inflammatory diseases of the respiratory tract. Assessment of the clinic and~     functional status bronchopulmonary system in the immunized patients. Development of~     methodical recommendations / study guides for the improvement of therapy in patients with~     different inflammation diseases of the respiratory tract.~   "
59516|NCT02787850|"~     Evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction in the~     abdomen using an applicator with the Crown Cooling Insert.~   "
59517|NCT02787837|"~     PROSABI is a prospective multicentre study to analyse circulating and tissue biomarkers that~     may predict prognosis and response in patients with CRPC treated conventionally with~     Abiraterone Acetate.~   "
59518|NCT02787824|"~     The purpose of this study was to compare the efficacy of two regimens of intravenous iron~     sucrose [continuous (in every hemodialysis session) versus intermittent (every 1-4 weeks)] on~     the response of rHuEPO in the maintenance phase of its administration in hemodialysis~     patients.~   "
59519|NCT02787811|"~     Superovulation will be conducted with 100 mg of oral clomiphene citrate (Clomifene; Young~     Poong Pharmaceutical, Incheon, Korea) for 5 days starting on day 3 of the menstrual cycle,~     followed by daily injection of 150 IU of human menopausal gonadotropin (hMG;Menogon;~     FerringPharamceutical Co, Germany). When more than 2 dominant follicles reached a diameter of~     17 mm or the urinary specimen showed positive results for luteinizing hormone (LH) surge,~     5000 IU of hCG (Pregnyl; Organon, Oss, the Netherlands) was injected intramuscularly.~   "
59520|NCT02787798|"~     The hyperactivation of the sympathetic nervous system is a feature of the heart failure and~     the determinants of disease progression and risk of sudden cardiac death. This research~     project aims to study, in the drug use conditions provided in the summary of product~     characteristics based on European marketing authorization (indications and dosage), the~     effect of the Entresto® on the activity of sympathic nervous system using the reference~     method, the microneurographic recording of sympathetic activity in muscle destiny (MSNA).~     This study will try to determine if the double inhibition of AT1 receptor and neprilysin~     activity result in lower sympathic nervous system burst rate versus single AT1 receptor~     inhibition using angiotensin-converting-enzyme inhibitor or AT1 receptor of angiotensin II~     inhibitor.~   "
59521|NCT02787785|"~     The MADIT S-ICD trial is designed to evaluate if subjects with a prior myocardial infarction,~     diabetes mellitus and a relatively preserved ejection fraction of 36-50% will have a survival~     benefit from receiving a subcutaneous implantable cardioverter defibrillator (S-ICD) when~     compared to those receiving conventional medical therapy.~   "
59522|NCT02787772|"~     Cirrhotic patients have a high incidence of abdominal wall hernias. Ascites and sarcopenia~     are risk factors to development of bigger hernias and frequent need for urgent surgery due~     parietal complications. However, hernia surgery is usually delayed in cirrhotic patients~     because of high morbidity and mortality.~      Methods: A prospective study of cirrhotic patients with abdominal wall hernia during January~     2009 to November 2014. Demographics, characteristics of underlying liver disease, type of~     hernia, complications and mortality of 246 enrolled patients were collected. Elective hernia~     repair was performed in 57 unselected patients, 186 patients were kept in clinical follow up.~     During follow up urgent hernia surgery was performed when unavoidable~   "
59523|NCT02787759|"~     We propose a study that uses challenging walking exercises as a research training program and~     compare balance and walking abilities against a non-challenging exercise program, in a group~     of 40 people with long standing (> 6 months) weakness that occurred after a stroke. Our main~     balance measure will be changes with the Berg Balance Score and Dynamic Gait Index, and our~     main walking measure will be walking speed over a 10 meter walkway and distance walked over a~     six minute period. Also, we will measure balance confidence, using scores on~     Activities-specific Balance Confidence Scale, changes in quality of life as measured by the~     Geriatric Depression Scale, SF-36 and Stroke Impact Scale. If challenging exercises are shown~     to be more effective than non-challenging exercises, then we will share this promising new~     approach with the community in hopes of improving people's lives after a stroke.~   "
59524|NCT02787746|"~     This study will evaluate the safety and Efficacy of donepezil in treatment of AD patients in~     China.~   "
59525|NCT02787733|"~     Rationale: Numerous studies have shown the positive effect of a healthy diet and regular~     moderate exercise. Although, exercise has also been correlated with an increase in reactive~     oxygen species (ROS) production and a higher incidence of injury. ROS production seems to~     induce muscle damage, which reduces muscle performance and induces fatigue. Increasing muscle~     recovery could be an effective way to increase exercise performance. Several food ingredients~     have been of growing interest due to their specific functioning on the human body. Citrus~     flavonoids are abundantly available in citrus fruits. Prior studies show a positive effect of~     citrus flavonoids on endothelial function, by promoting vasodilation. In addition it has a~     positive effect on the nitric oxide (NO) synthesis, a known compound in regulating~     endothelial response. This capacity of citrus flavonoids could be useful in stimulating~     performance and recovery after exercise. Additionally, the ability of scavenging ROS could~     reduce muscle damage caused by exercise induced oxidative damage.~      Objective: Determine the 4-week effect of daily citrus flavonoid supplementation on exercise~     recovery and performance.~      Study design: Randomized, double-blind, placebo-controlled study with parallel design, in~     which 40 subjects engage in three exercise sessions. The sessions will be subdivided into a~     pre-test and test 1 and 2. Between test 1 and 2, participants receive daily for 4 weeks~     citrus flavonoid supplement or a placebo. Each day, subjects should consume 2 capsules each~     morning, containing in total 500 mg of citrus flavonoids or 500 mg placebo.~      Study population: The subjects will be healthy normal weight trained males, with an age of 18~     - 25. Additionally, subjects are non-smokers and free of a medication.~      Intervention: Participants will be randomly placed in either the citrus flavonoid or placebo~     group. Participants will be instructed to ingest 2 capsules each morning for 4 consecutive~     weeks. Each capsule equals to 250 mg of citrus flavonoids or cellulose in case of the placebo~     treatment.~      Main study parameters/endpoints: The main study parameter is the average amount of work load~     produced during the 10-minute time trail test. In addition, oxygen per minute will be~     determined as well as the heart rate. Finally, for each test, the subjective rating of~     perceived exertion (RPE) will be determined during the pre-test and test 1 and 2 by using a~     Borg scale.~   "
59526|NCT02787720|"~     A randomized controlled blinded study in patients treated for Acute Respiratory Distress~     Syndrome (ARDS) in the mixed medical-surgical intensive care units (ICU) of four academic~     teaching hospitals in Tehran, Iran were conducted to examine the effects of Varied~     Rehabilitation Techniques on Survivors of ARDS patients. Patients were randomized in the~     emergency department at the time of ICU admission to one of four groups labeled groups 1, 2,~     3 and 4, respectively.~   "
59527|NCT02787707|"~     The main objective of this research is the role of the Persumac(an Iranian traditional~     remedy) on refractory Chemotherapy Induced Nausea and Vomiting (CINV) in breast cancer~     patients. Investigators assess effect of Persumac on the number/severity of nausea/ vomiting~     in acute and delayed phase.~   "
59528|NCT02787694|"~     Locomotor disability remains a major obstacle to community function in stroke survivors. This~     disability is best characterized by the reduced gait speed and enhanced risk of falls that is~     observed in the majority of stroke survivors. Current robotic systems have focused on~     repetitive stepping in constrained, less-challenging environments than overground training~     and have failed to produce results that can justify their use. In contrast to this approach,~     this study will use a combinatorial approach on a moving platform (KineAssist-Mobility~     Activity Center) that simulates and enhances the challenges of overground training. We focus~     on five critical factors that contribute to reduced speed and fall risk during mobility~     activities: 1) lower limb weakness; 2) slow lower limb movements; 3) reduced balance; 4)~     reduced ability to respond to challenges during walking; and 5) reduced aerobic capacity. The~     end product of this study is to develop a comprehensive and standardized system for assessing~     and prescribing specific training modalities that can be used by clinicians to help stroke~     survivors who are limited by slow walking speed and high fall risk, and can improve~     participation in mobility activities.~   "
59529|NCT02787681|"~     The aim of this study is to verify the safety and accuracy of an FDA-approved device called~     the NEMO™ Gauge to aide in the proper positioning of the endotracheal tube (ETT), inserted in~     the lungs of patients admitted to the intensive care unit. The hope is that the NEMO™ Gauge~     is able to properly determine the correct position of the endotracheal tube without the use~     of a chest radiograph (chest x-ray). The study investigators anticipate sixty-eight (68)~     subjects will participate in this study at three (3) study centers in the Inland Empire of~     Southern California, with subjects being enrolled at Loma Linda University Medical Center,~     Riverside University Medical Center and Loma Linda Veterans Affairs Hospital.~   "
59530|NCT02787668|"~     The purpose of this study is to determine the effects of a low carbohydrate diet vs a low fat~     diet on improvement in aminotransferases, hepatic fat infiltration, markers of inflammation,~     insulin resistance, and body composition in obese adolescents with non-alcoholic fatty liver~     disease (NAFLD).~   "
59550|NCT02787408|"~     The purpose of the study is to assess the safety and device performance of the Edwards~     Tricuspid Transcatheter Repair System in patients with clinically significant, symptomatic,~     tricuspid regurgitation who are at high surgical risk for standard tricuspid~     repair/replacement.~   "
59943|NCT02782234|"~     Contract management is a new management mode.~      To help patients achieve fluid balance through contract management, that is:~        1. edema, congestive heart failure and other similar symptoms begin to reduce to disappear;~        2. Blood pressure control in normal range, that is 90-140/60-90mmHg, or the target value~          prescribed by the doctors；~        3. Fluid intake and output keep in balance;~        4. No imbalance symptoms turn out, such as edema, congestive heart failure, etc.~   "
59531|NCT02787655|"~     The purpose of this study is to examine the impact of a combined cognitive training and~     aerobic exercise intervention in sedentary older adults. It is hypothesized that the aerobic~     exercise will potentiate and increase the generalizability of the cognitive training.~     Importantly, this study will focus on older adults at-risk for mobility disability. This area~     is of particular importance considering a large percentage of adults are entering old age and~     therefore likely to suffer from age-related cognitive decline and mobility disability.~      To address the investigators' research question 60 adults (age 18-89) will be randomized to~     one of two 12 week intervention groups: 1) Cognitive Training alone (CT) or 2) Aerobic~     Exercise + Cognitive Training (AE+CT). The aerobic exercise arm of the study will follow the~     same format shown to improve a broad range of executive functions in older adults in previous~     research. The cognitive training arm will consists of a popular commercially-available brain~     fitness program that has demonstrated specific cognitive improvements and high adherence.~   "
59532|NCT02787642|"~     A phase Ib study of Olaparib with concomitant radiotherapy in locally advanced/unresectable~     soft-tissue sarcoma.~   "
59533|NCT02787629|"~     Patients presenting for elective surgery requiring orotracheal intubation will be randomized~     to having the ETT inserted into the pharynx simultaneous to GlideScope insertion and then~     having the ETT advanced under GlideScope guidance into the trachea, or, being intubated in~     the more common fashion with the GlideScope being inserted first and having the ETT then~     advanced via the pharynx into the trachea.~   "
59534|NCT02787616|"~     Rosacea is a common disease characterized by inflammation and vascular abnormalities of the~     facial skin and ocular surface. The exact pathogenesis of papulopustular rosacea is not well~     understood and current methods to treat this disease are often unsatisfactory. The purpose of~     this study is to develop gene expression profiles of papulopustular rosacea compared to those~     of normal skin. The investigators hope to better understand the abnormal gene functions that~     might contribute to this condition. This understanding may lead to the development of~     additional and better treatments for rosacea.~   "
59535|NCT02787603|"~     Introduction: Acute Heart Failure is frequently decompensated by pulmonary infection, but the~     diagnosis of pulmonary infection sometimes is difficult in these patients due to similar~     signals and clinical symptoms in both pathologies. Furthermore, when it is possible the~     diagnosis of pulmonary infection, physicians may have difficult to determine etiology and~     delaying antibiotic therapy. Procalcitonin (PCT) have been used like a biomarker to determine~     the period of use of antibiotics in patients with acute respiratory infections. It is~     specific for bacterial infections and it have showed as a marker of severity infection and~     may help to determine interruption period of antibiotic therapy in a safety way for the~     patient. Aim: Evaluate levels of PCT related to interruption of antibiotics in patients with~     decompensated acute heart failure (DAHF) with suspected bacterial pulmonary infection.~     Methods: In this pilot project will be included around 100 patients, randomized in two~     groups: group A (PCT levels may guide the interruption of antibiotic at day 5) or group B~     (antibiotic period will be determined by the physician without the knowledge of PCT levels).~     Will be collected laboratorial and clinical data at days 0,3 and 5. Both groups will be~     compared to evaluate PCT levels and total period of antibiotic therapy, hospitalization and~     readmission in 30 days. This study will determine the sensibility/specificity of PCT in~     patients with DAHF.~   "
59536|NCT02787590|"~     Participants are randomly allocated to one of two treatment groups. In one group,~     participants are given capsules of simvastatin to take orally (by mouth) for 24 months. In~     the other group, participants are given placebo (dummy) capsules to take orally for 24~     months. At the start of the study, when they receive their medication, participants complete~     a number of questionnaires and motor (movement) tests (a walking test and a finger tapping~     test). Participants in both groups also attend a further 6 clinic visits after 1, 6, 12, 18~     and 24 and 26 months, where they are asked about their health and any medication they are~     taking, as well as repeating the questionnaires and motor tests. For 4 of the clinic visits,~     the participants will be asked to attend in the 'OFF medication' state (having omitted their~     usual PD medication) so that the researchers can get a true picture of their disease without~     it being masked by their normal medication.~   "
59537|NCT02787577|"~     Short sleep duration has been associated with increased risk of weight gain and development~     of non-communicable diseases. Sleep deprivation studies have suggested the link between~     restricted sleep and risk of adiposity and cardiometabolic dysregulation may be causal.~     However, the severity and acuteness of sleep restriction schedules in laboratory-based~     studies could hinder the ecological validity of the findings. The pragmatic way forward is to~     assess how improved sleep in habitually short sleepers impacts the aforementioned outcomes.~     This study assesses the feasibility of lengthening sleep in short sleepers, as well as how~     improved sleep duration and/or quality impact metabolic health, body composition, energy~     balance and cardiovascular risk.~   "
59538|NCT02787564|"~     The study aims to investigate whether the provision of free fresh fruits and vegetables to~     middle-aged men at risk of poverty increases their fruit and vegetable intake over a period~     of 4 weeks.~   "
59539|NCT02787551|"~     Primary Objective:~      To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination~     (FRC) versus GLP-1 receptor agonist (GLP-1 RA) in hemoglobin A1c (HbA1c) change.~      Secondary Objectives:~      To compare the overall efficacy and safety of the insulin glargine/lixisenatide fixed ratio~     combination (FRC) to GLP-1 receptor agonist (GLP-1 RA) on top of metformin (with or without~     pioglitazone, with or without SGLT2 inhibitor) in patients with type 2 diabetes.~      To evaluate safety, efficacy and other endpoints of FRC up to the end of the extension~     period.~   "
59540|NCT02787538|"~     This proof-of-concept randomized trial evaluates the effectiveness of using an online~     decision aid (US-ANSWER-2) in the decision-making to start or switch biologic therapy in US~     patients with rheumatoid arthritis.~   "
59592|NCT02786849|"~     The objective of this study will be to evaluate the effects of neuromuscular electrical~     stimulation of high and low frequency and intensity, performed during hemodialysis (HD), on~     peripheral muscle strength, exercise capacity and muscle change and inflammation markers in~     patients with chronic kidney disease (CKD).~   "
60456|NCT02775539|"~     The purpose of this study is to evaluate the efficacy and safety of mirabegron (a B3~     adrenergic receptor agonist) in patients with pulmonary hypertension secondary to heart~     failure by conducting a randomized multicenter phase II placebo-controlled clinical trial.~   "
59541|NCT02787525|"~     The aim of the study is to compare intermedium-term clinical outcomes, including~     thromboembolic events and bleeding complications between patients with non-valvular atrial~     fibrillation treated with either oral anticoagulation or who had undergone LAA-closure (left~     atrial closure).~      A questionnaire is sent to the patients and if there is some information missing or unclear,~     the investigators will contact the patient or the treating physicians to get the~     missing/unclear information.~      The study population consists of 500 patients with non-valvular atrial fibrillation (AF) who~     underwent LAAC between the years 2009 and 2014 in two centers (the Bern University hospital~     und Zurich University hospital) and a similar group of 500 patients with non-valvular AF~     treated with oral anticoagulation (OAC).~      In order to compare the two groups and reducing the bias due to confounding variables, a~     propensity score matching will be performed.~      Study hypothesis is that left atrial appendage closure is non-inferior in terms of efficacy~     and safety in comparison to lifelong oral anticoagulation in patients with non-valvular~     atrial fibrillation.~   "
59542|NCT02787512|"~     Currently, routine preoperative biliary drainage (PBD) was not recommended. However, PBD is~     still necessary in case of patients with cholangitis or very high level of bilirubin or~     patients who are expected to receive delayed surgery.~      The aim of this clinical trial is to demonstrate non-inferiority of uncovered self-expandable~     metal stent to plastic stent for PBD by endoscopic retrograde cholangiopancreatography in~     patients with periampullary cancer undergoing curative intent pancreaticoduodenectomy.~   "
59543|NCT02787499|"~     The study design is an open-label, randomized controlled trial. The study will be conducted~     at study sites in Uganda and South Africa. The study population will include HIV-infected~     patients on first-line antiretroviral therapy with a recent viral load >1,000~     copies/milliliter (or dried blood spot viral load >1,000 copies/milliliter). Eligible~     participants will be randomized to the WHO-based standard of care for management of virologic~     failure or immediate resistance testing to guide ART regimen decisions. The primary outcome~     of interest will be viral suppression (<200 copies/mL) at 9 months after study enrollment,~     and will be assessed using an intention to treat analysis, where missing or absent results~     will be considered failures. Secondary outcomes of interest will be viral suppression below~     the limit of assay detection, viral suppression on continuation of first-line (non-nucleoside~     reverse transcriptase inhibitor [NNRTI]-based) therapy, drug resistance at study conclusion,~     and mortality, among others. The overarching goal of this study is to determine whether~     addition of routine resistance testing, to guide management of virologic failure and sustain~     the successful completion of the HIV continuum of care, improves clinical outcomes and~     reduces costs for patients with virologic failure on first-line therapy in sub-Saharan~     Africa.~   "
59544|NCT02787486|"~     In January 2007, the American Congress of Obstetricians and Gynecologists (ACOG) revised its~     guidelines that now recommend physicians are ethically obligated to fully inform all pregnant~     women that screening for fetal chromosomal abnormalities including biochemical screening~     tests and invasive procedures such as CVS or amniocentesis is available, regardless of age.~     Further, it is entirely up to the patient to decide whether or not she wishes to be screened~     for fetal chromosomal abnormalities without judgment from the physician.~      Noninvasive laboratory-developed tests (LDTs) that detect an abnormal amount of maternal and~     fetal DNA in an expectant mother's blood sample (known as circulating cell-free DNA) are now~     available. These LDTs have not been cleared or approved by the U.S. Food and Drug~     Administration (FDA). Although LDTs to date have not been subject to U.S. FDA regulation,~     certification of the laboratory is required under the Clinical Laboratory Improvement~     Amendments (CLIA) to ensure the quality and validity of the test.~      To sample collection study will obtain whole blood specimens from pregnant subjects to be~     used for development of prenatal assays to assist in the screening for fetal genetic~     abnormalities, infectious and other diseases, and blood group typing through detection of~     circulating cell-free DNA extracted from maternal plasma.~   "
59545|NCT02787473|"~     To evaluate the efficacy and toxicity of patients with inoperable squamous cell lung cancer~     treated with pemetrexed plus cisplatin with concurrent radiation therapy followed by~     docetaxel consolidation. An exploratory biomarker analysis in blood and tumor samples is also~     planned.~   "
59546|NCT02787460|"~     The University of Florida offers relationship education programs named ELEVATE, for couples,~     and Smart Steps, for couples in stepfamilies, in Citrus, Duval, Manatee, Palm Beach, and~     Santa Rosa counties. Each workshop comprises 4 2.5-hour long sessions. The STREAMS evaluation~     will examine whether text messages informed by behavioral insight theory can improve couples'~     attendance at relationship skills education group sessions, and if so, which kinds of~     messages are most effective~   "
59547|NCT02787447|"~     The investigators postulated that the exploitation of the pro-immunogenic effects of~     radiotherapy with thymosin might result in abscopal responses among patients with metastatic~     cancer. The research is designed to evaluate the efficacy and toxicity of patients treated~     with hypofractionated radiotherapy combined with thymosin alpha 1. An exploratory biomarker~     analysis in blood and tumor samples is also planned.~   "
59548|NCT02787434|"~     This is a multicenter study that involves research on screening for prostate cancer. This~     study pilot tests a culturally appropriate decision aid (DA) for African American (AA) men~     that will empower them to take part in decision-making regarding prostate cancer screening~     (PCS). The Prostate Cancer Screening Preparation (PCSPrep) tool was designed with intend to~     be delivered in primary care settings with attention to patient/provider interaction. Funding~     for this study comes from the National Institute of Health/National Cancer Institute~     (1R21CA178296).~   "
59549|NCT02787421|"~     In this study, the study team will investigate the validity and role of nasal dilator strips~     (NDS), a novel method to determine the site of nasal valve compromise (NVC), in the~     pre-operative evaluation. The method involves placing the strip sequentially at the upper and~     lower lateral cartilage and recording the location of the optimal airway based on patient's~     subjective symptoms.~      Investigators seek to assess surgical outcomes in participants undergoing rhinoplasty based~     on pre-operative NDS classification. The Nasal Obstruction and Septoplasty Effectiveness~     (NOSE) instrument will be used to evaluate subjective symptoms of nasal obstruction, before~     and after the operation and comparing these scores.The results will help determine the~     effectiveness and predictive value of NDS in isolating the site of NVC.~   "
59551|NCT02787395|"~     Anterior dislocation of the shoulder (glenohumeral joint) is one of the most prevalent~     dislocations. Following a first dislocation recurrence rates of up to 80% have been reported.~     Many patients will seek medical assistance for reduction of the shoulder after each of these~     recurrent dislocations. The investigators describe the results of reduction of anterior~     glenohumeral dislocation using a modified self manipulated Milch technique that can be~     performed by the patients themselves after simple guidance and demonstration. This method is~     directed to patients who are not willing or cannot have surgical stabilization and may be in~     a place where medical assistance is not available.~   "
59552|NCT02787382|"~     BACKGROUND~      Myocarditis and pericarditis are inflammatory conditions of the heart commonly due to viral~     or autoimmune etiologies. Human CMV represents one of the leading causes of congenital~     infections worldwide. There is limited data regarding the cardiac function of fetuses and~     infants with CMV.~      OBJECTIVE~      To provide insight regarding the presence of myocardial involvement in fetuses and infants~     with CMV infection.~      PATIENTS & METHODS~      Up to 100 fetuses with suspected CMV infection will be enrolled during a 3 years period.~     Patients will undergo detailed US examinations including dedicated neurosonography and~     echocardiography starting at the time of the first referral and every 3-4 weeks until~     delivery and at the 2-7th day birth. Cardiac scans of fifty pregnant women and the healthy~     women from the group will serve as controls~   "
59553|NCT02787369|"~     This research study is studying a drug called ACY-1215 in combination with ibrutinib or~     idelalisib as a possible treatment for Relapsed or Refractory Chronic Lymphocyic Leukemia~     (CLL).~   "
59554|NCT02787356|"~     The purpose of this study is to (1) collect trained observer scores and digital images of~     skin irritated by generic and RLD Lidocaine 5% delivered via TDS, and (2) assess performance~     of an automated system for predicting scores directly from the digital images~   "
59555|NCT02787330|"~     The psychosocial effects of childhood cancer and its demanding medical treatment can affect~     not only the ill child but the whole family, particularly siblings who are often overlooked~     given the terrible circumstances these families face. Current evidence suggests that negative~     long-term psychosocial effects of childhood cancer may be more severe in siblings than in the~     child with cancer. Addressing these effects on siblings may benefit the child with cancer and~     the entire family. Thus, early psychosocial preventive interventions are needed to foster~     psychosocial adjustment in siblings and promote better quality of life for the entire family.~     The immediate objective of this study is to address siblings' psychological distress by~     assessing feasibility and efficacy of a manualized group intervention for siblings of~     children with cancer (Siblings Coping Together, SibCT). A longer term objective is that the~     evidence-based intervention could then be exported to other centres across Canada and~     internationally. Additionally, the study results will identify biomedical, personal, familial~     and social determinants of intervention outcomes that can guide clinical effort for those at~     greatest risk. Finally, the overall aim of the project is to reduce psychological distress~     and improve quality of life for siblings and families impacted by a cancer diagnosis and its~     demanding treatment.~   "
59556|NCT02787317|"~     Prolonging infusions may decrease myocardial damage associated with bivalirudin use during~     primary PCI. The investigators hypothesized that continuing the bivalirudin infusion~     commenced during the procedure at the PCI recommended dose for 4 hours would prevent~     myocardial damage.~   "
59557|NCT02787304|"~     The purpose of this study is to determine if the investigational treatment volixibat (SHP626)~     is safe, tolerable and effective in adults with nonalcoholic steatohepatitis (NASH).~   "
59558|NCT02787291|"~     To demonstrate safety and efficacy of the Durata or Optisure high voltage lead and Ellipse VR~     ICD in an MRI environment.~   "
59559|NCT02787278|"~     The current study aims to evaluate the safety of SP-8203, designing in two stages (stage-1,~     stage-2) to evaluate the safety and efficacy of the combination therapy of SP-8203 and rtPA~     for the occurrence of cerebral hemorrhage in patients with acute ischemic stroke receiving~     rtPA standard of care.~   "
59560|NCT02787265|"~     This is a prospective, multi-center, observational follow-up study observing the~     effectiveness of high density spinal cord stimulation in patients with failed back surgery~     syndrome patients with back and leg pain.~   "
59561|NCT02787252|"~     The purpose of this study is to observe the efficacy of stimulation on over all pain relief~     as reported in an initial cohort of 6 patients treated with the Freedom High Frequency Spinal~     Cord Stimulator (SCS) System for low back and/or leg pain.~   "
59562|NCT02787239|"~     Multicenter, Randomized, Double-blind, Parallel, Phase III Clinical Study to Compare the~     Efficacy and Safety of Rituximab Biosimilar HLX01 and MabThera in Combination With CHOP, in~     Previously Untreated Subjects With CD20+ DLBCL~   "
59563|NCT02787226|"~     Total shoulder replacement is associated with considerable postoperative pain. A common~     method to treat and prevent this post operative pain is to place a catheter in the neck and~     leave it in place for up to 48 hours. The catheter delivers a medication called ropivacaine~     directly to a major nerve near your shoulder. It is very effective at stopping pain. In~     addition to preventing pain, it also prevents movement of the arm because it blocks the nerve~     completely.~      A newer method of treating post operative pain uses only a series of small injections into~     the joint, skin, and muscles of the shoulder near the end of the surgery. This medication,~     liposomal bupivacaine (Exparel), potentially provides analgesia for greater than 48 hrs but~     does not require a catheter to remain in place and does not prevent patients from moving~     their arm after surgery because it only blocks the pain portion of the nerve. Both methods~     also frequently include the addition of oral and injected pain medicines like narcotics to~     effectively control the pain.~      Ropivacaine and Exparel both work well for postoperative pain after total shoulder~     replacement. It is not known, however, if one method is superior in its ability to~     treat/prevent pain or which method may have fewer side effects. The purpose of this study is~     to randomly assign patients to receive either a catheter with ropivicaine or Exparel~     injections to help determine if one method is superior in pain relief and if either method~     has fewer side effects.~   "
60018|NCT02781246|"~     Dexmedetomidine can prolong the duration of local anesthetics, but the effect of perineural~     dexmedetomidine on the potency of ropivacaine for brachial plexus blocks in pediatric~     patients has not been investigated. This study was designed to determine the effect of~     perineural dexmedetomidine on ropivacaine for brachial plexus blocks in pediatric patients~   "
59564|NCT02787213|"~     Prospective multicenter observational study to further develop and validate a preterm birth~     risk predictor, using a preterm cutoff at 37 0/7 weeks gestation and at 35 0/7 weeks~     gestation. A single maternal peripheral blood sample will be collected for analysis. Data~     related to potential risk factors for preterm birth will be obtained through maternal~     interview and review of medical records. Subjects will be followed through the delivery~     process to assess the course of pregnancy, labor, and to document any related maternal~     complications. Neonatal outcomes will be gathered from the medical record for up to 28 days~     of life or discharge, whichever occurs first.~   "
59565|NCT02787200|"~     This study aims to identify various time-variant and time-invariant components of EEG signals~     using advanced signal processing techniques, such as machine learning. The investigators'~     ultimate goal is to develop universal or customised brain-computer interface that are stable~     across days or even years.~   "
59566|NCT02787187|"~     The purpose of this study is to compare outcomes of patients undergoing standard or extended~     lymphadenectomy in pancreaticoduodenectomy for pancreatic cancer~   "
59567|NCT02787174|"~     Asthma is common in children and impacts their health. There are effective medications for~     improving asthma, but some families have difficulty using medicines on a regular basis. This~     study in the emergency department will improve medicine use for children 2-12 years-old with~     asthma by developing content for a customized, tablet-based electronic intervention. A~     clinical trial will then be used to compare asthma outcomes for this intervention with~     routine asthma care.~   "
59568|NCT02787161|"~     This is a randomized controlled clinical trial that will analyze the impact of high volume~     online HDF in comparison to high-flux HD on measured physical activity.~   "
59569|NCT02787148|"~     Prospective studies indicate that patients with depression are at increased risk for~     cardiovascular disease. Depression is also associated with a number of hemodynamic features,~     which are known risk factors for cardiovascular morbidity such as increased heart rate,~     reduced heart rate variability and blood pressure alterations. These hemodynamic alterations~     may explain in part the increased cardiovascular risk associated with depression.~      The purpose of this study is to determine whether treatment for depression with cognitive~     behavior therapy (CBT) is effective in reducing hemodynamic cardiovascular risk factors.~     Hemodynamic assessments including heart rate, heart rate variability, continues blood~     pressure, blood pressure variability, baroreceptor sensitivity and peripheral vascular~     resistance will be conducted at baseline, after treatment and 2-month follow up. In addition,~     circadian hemodynamic variations such as 24-hour heart rate variability, nocturnal blood~     pressure dipping and immunological biomarkers will be assessed. One-hundred patients with~     Major Depression will be randomly assigned to either a CBT treatment condition (14 hour-long,~     weekly sessions) or a waitlist condition, to control for potential changes in hemodynamic~     parameters without any intervention and the impact of repeated-measurement.~   "
59570|NCT02787135|"~     The aim of the present single-blind randomized-controlled therapy study is to assess the~     efficacy of a new form of Cognitive Behavioral Therapy for delusions with a focus on emotion~     regulation, improvement of self-esteem and sleep quality (CBTd-E).~   "
59571|NCT02787122|"~     The present study is a pilot single-blind randomized controlled therapy study. Its aim is to~     assess the efficacy of an emotion-focussed form of Cognitive behavior Therapy that focusses~     on emotional processes that are involved in the formation and maintenance of delusions such~     as emotional stability, emotion regulation and self-esteem.~   "
59572|NCT02787109|"~     The present trial is a phase I first in human, double blind, parallel and placebo controlled~     trial of SSI's adjuvanted chlamydia vaccine CTH522: CTH522-CAF01 (CAF01 is an adjuvant~     system) and CTH522-Al(OH)3. The trial will be conducted at Imperial College Research site in~     the United Kingdom.~      Subjects are randomly assigned to one of the following three treatment groups in a ratio of~     3:3:1.~      This trial consisted of 10 visits and 5 telephonic interviews~   "
59573|NCT02787096|"~     Anterior cruciate ligament (ACL) tear is frequent, but the diagnosis of partial tears is~     difficult. Standard MRI may be used but is of limited diagnostic value. The present study~     aimed to evaluate the diagnostic interest of dynamic knee laxity measurement coupled to MRI~     for the diagnosis of ACL tear.~   "
59574|NCT02787083|"~     Bladder pain syndrome/interstitial cystitis (BPS/IC) is a difficult disease to both diagnose~     and treat. It is defined as an unpleasant sensation (pain, pressure, or discomfort) perceived~     to be related to the urinary bladder and associated with lower urinary tract symptoms for at~     least 6 weeks duration, in the absence of infection or other identifiable causes. Pain is the~     universal symptom, but many also experience symptoms of overactive bladder, possibly directly~     related to the mechanism of pain. Treating pain may influence the symptom of urgency, if the~     urge arises from a need to alleviate pain. In some patients whose pain improves with~     treatment, troubling overactive bladder symptoms still remain. Beta-3 adrenergic agonists~     have been found to decrease signaling of C-fibers in animal models. So, the investigators~     hypothesize that mirabegron, which is FDA-approved for treatment of overactive bladder, would~     also improve symptoms in patients with BPS/IC. As a selective beta-3 agonist, mirabegron acts~     on the beta-3 receptors found in the bladder which mediate relaxation of the detrusor muscle.~     It has been shown to significantly decrease the number or micturition episodes, urgency~     episodes, and increased mean volume of urine voided per micturition. It also has a favorable~     tolerability profile.~   "
59603|NCT02786706|"~     Optic Nerve Ultrasound (ONUS) is a promising non-invasive tool for the detection of raised~     Intracranial Pressure (ICP). Variability in the optimal Optic Nerve Sheath Diameter (ONSD)~     threshold corresponding to elevated ICP in multiple studies limits the value of ONUS in~     clinical practice. The investigators goal is to develop and validate an automated image~     analysis algorithm for standardization of ONSD measurement from ultrasound videos. Patients~     with acute brain injury requiring invasive ICP monitoring will undergo bedside ONUS, with~     blinded ONSD measurement by an expert investigator. The image analysis algorithm will then be~     used to measure ONSD and accuracy determined compared to the reference standard expert~     measurement.~   "
60019|NCT02781233|"~     This study evaluates the clinical impact of a progressive resistance training program in~     adults patients with haemophilia~   "
60614|NCT02773485|"~     The study evaluates impact of high dose radiation on overall survival in patients with~     unresectable nonmetastatic cholangiocarcinoma. The study randomizes patient between systemic~     chemotherapy alone and systemic chemotherapy and high dose radiation~   "
59575|NCT02787070|"~     Plasmodium vivax can form dormant liver stages that reactivate weeks or months following an~     acute infection. Recurrent infections can be associated with a febrile illness, a cumulative~     risk of severe anaemia, and even mortality. In co-endemic areas the risk of recurrence after~     both P. vivax and P. falciparum infections can be over 50% within 3 months. The only drug we~     have to kill P. vivax hypnozoites is primaquine which is currently given as a 14 day regimen.~     In Papua a retrospective study found very low effectiveness for unsupervised treatment. If~     true this has profound effects on treatment policy, suggesting that greater efforts are~     needed to encourage adherence to treatment.~      We propose a cluster randomized, controlled, open label trial to assess the effectiveness of~     unsupervised versus supervised primaquine treatment in patients with uncomplicated malaria.~     Since the risk of recurrent P. vivax is high in patients with either P. vivax or P.~     falciparum, both infections will be included in the study. The study will be conducted in~     Mimika, in the southern part of Papua Province, Indonesia. Participants will be enrolled at~     village health posts and provided with schizontocidal treatment plus primaquine radical cure~     which will be either supervised or unsupervised depending on which cluster the clinic is in.~     Participants will be followed up for 6 months and assessed in regular intervals for the~     presence of patent and sub-patent malaria. The outcome of the study will contribute to an~     improved treatment scheme for uncomplicated malaria in this area.~   "
59576|NCT02787057|"~     Intra-peritoneal administration of antibiotics covering both gram-positive and gram-negative~     organisms was recommended as first-line regimen for the management of peritoneal dialysis~     related peritonitis. Oral administration of quinolones can also achieve effective serum~     concentrations, and is more convenient and economical. We conducted a pilot randomized~     controlled study to compare the effects on peritonitis cure and relapsing rates between oral~     moxifloxacin plus IP vancomycin and conventional IP vancomycin plus ceftazidime.~   "
59577|NCT02787044|"~     INVESTED will test the hypothesis that high dose trivalent influenza vaccine will reduce~     cardiopulmonary events to a greater extent than standard dose quadrivalent influenza vaccine~     in high-risk cardiovascular patients with a recent history of myocardial infarction or heart~     failure. The trial will enroll 9300 participants over one Vanguard (pilot) season and three~     additional influenza seasons. The primary endpoint will be a composite of all-cause mortality~     or cardiopulmonary hospitalization.~   "
59578|NCT02787031|"~     The investigators will use health administrative data to examine the variation of anesthesia~     type for hip fracture surgery, as well as sources of variation and predictors of variation.~   "
59579|NCT02787018|"~     The investigators want to compare the effectiveness of dexamethasone and dexmedetomidine as~     an adjuvant to 0.5% ropivacaine for supraclavicular brachial plexus block on the onset of~     block and duration of analgesia, so that the investigators can choose the better adjuvant for~     the investigators routine practice of regional anesthesia.~   "
59580|NCT02787005|"~     This is a study of pembrolizumab (MK-3475) in participants with metastatic~     castration-resistant prostate cancer (mCRPC). Participants will be enrolled into one of five~     cohorts: Cohort 1 (participants with programmed cell death ligand 1 [PD-L1]-positive,~     measurable disease), Cohort 2 (participants with PD-L1 negative, measurable disease), Cohort~     3 (participants with bone-metastases and non-measurable disease) post-chemotherapy, Cohort 4~     (participants with Response Evaluation Criteria in Solid Tumors version 1.1- [RECIST~     1.1]-measureable disease) and Cohort 5 (participants with bone metastases only or~     bone-predominant disease) pre-chemotherapy.~   "
59581|NCT02786992|"~     This prospective randomized double-blind clinical trial will be conducted at Ain-Shams~     University Maternity Hospital, Cairo, Egypt. Patients eligible for elective lower segment~     cesarean section will be randomized to 2 groups. Group 1: will receive 400 ug misoprostol~     following + 10 IU oxytocin intravenous slowly after cord clamping. Group 2: will receive 100~     ug carbetocin intravenous after cord clamping.~   "
59582|NCT02786979|"~     The objective was to evaluate the efficacy and safety of combination of beraprost and aspirin~     for prevention of arteriosclerosis progress in type 2 diabetes mellitus patients.~   "
59583|NCT02786966|"~     Each year, half a million patients with a potential neck (c-spine) injury are transported to~     Ontario emergency departments (ED). Less than 1% of all these patients actually have a neck~     bone fracture. Even less (0.5%) have a spinal cord injury or nerve damage. These injuries~     usually occur at the time of initial trauma and not during transport to the ED. Currently,~     paramedics transport all trauma victims (with or without an injury) by ambulance using a~     backboard, collar, and head immobilizers. Trauma victims can stay immobilized for hours until~     an ED bed is made available or until x-rays are completed. Importantly, long immobilization~     is often unnecessary, it causes patient discomfort and pain, decreases community access to~     paramedics, contributes to ED crowding, and is very costly.~      The investigators developed the Canadian C-Spine Rule (CCR) for alert and stable trauma~     patients. This decision rule helps ED physicians and triage nurses to safely and selectively~     remove immobilization, without x-rays and missed injury.~      The investigators will evaluate the possibility and benefits of allowing paramedics to use~     the CCR in the field in 12 new communities from across Ontario. Patients have suggested the~     investigators include measures of pain and discomfort from being immobilized during transport~     as important patient-centred outcomes. The investigators will also measure the impact on the~     ED, and how much money could be saved if more paramedics were allowed to use the CCR. The~     investigators will also assess if sex, age, language barriers, or living far from the~     hospital (long transport time) will affect the outcomes of the study.~   "
59604|NCT02786693|"~     Fever of unknown origin (FUO) and biologic inflammatory syndrome of unknown origin (SII) are~     two frequent causes of hospitalization or consultation in infectious disease unit and~     internal medicine.~      There are many etiologies, in four categories: infections, auto-immune disease, cancer and~     miscellaneous causes. Currently there is no specifics recommendations to follow a diagnosis~     way of FUO and SII.~      Purpose: Evaluation of clinical practices in the diagnosis of fever and biologic inflammatory~     syndrome of unknown origin, in two units of the University Grenoble Hospital.~   "
60020|NCT02781220|"~     The main purpose of this study is to build upon the evidence captured in the Imaging Dementia~     - Evidence for Amyloid Scanning (IDEAS; NCT02420756) trial to include valuable information~     regarding patient-reported outcomes and physician confidence in diagnosis and management~     based on the Implications for Management of PET Amyloid Classification Technology (IMPACT;~     NCT number not yet assigned) trial design.~   "
59584|NCT02786953|"~     Adolescents with type 1 diabetes (T1D) are at increased risk for problems with adherence and~     suboptimal glycemic control, and novel approaches are needed to improve outcomes in this~     high-risk population. The majority of adolescents obtain insufficient sleep (defined as <8~     hours/night), and sleep disturbance has been significantly associated with poorer adherence~     and predicted greater problems with quality of life and worse glycemic control. Yet, no~     interventions have addressed sleep in youth with T1D. Working from a biopsychosocial and~     contextual model of sleep, the investigators propose to tailor a sleep-promoting intervention~     to meet the needs of adolescents with T1D by conducting interviews with to identify the~     barriers and facilitators to adequate sleep specific to this population. The sleep-promoting~     intervention will be developed and tested, building on successful sleep interventions in~     other populations, including components such as limiting caffeine, establishing a media~     curfew, and positive bedtime routines, while addressing the needs unique to adolescents with~     T1D, such as fear of hypoglycemia. The study will be conducted by a multidisciplinary team,~     consisting of Sarah Jaser, PhD, a pediatric psychologist, and two co-investigators, Beth~     Malow, MD, MS, a neurologist with specialty in sleep medicine, and Jill Simmons, MD, a~     pediatric endocrinologist. Sleep is a potentially modifiable risk factor that may have both a~     physiological and behavioral impact on diabetes outcomes. Given the strong associations~     between sleep and diabetes outcomes in the preliminary data, and recent evidence from sleep~     restriction studies indicating the impact of insufficient sleep on insulin sensitivity,~     behavior, and mood, there is reason to believe that a sleep-promoting intervention has the~     potential to improve outcomes in adolescents with T1D indirectly by improving adherence and~     directly through its effect on metabolic function. Therefore, the proposed study offers a~     novel approach to improve adherence, quality of life, and glycemic control in adolescents~     with T1D.~   "
59585|NCT02786940|"~     2-3% of emergency department (ED) syncope patients suffer arrhythmia/death within 30-days of~     disposition (either as inpatient or at home) and the investigators recently developed the~     Canadian Syncope Arrhythmia Risk Score (CSARS) to predict these outcomes. Currently, only~     holter monitoring is used and is applied a few days later. New and innovative remote~     (out-of-hospital) external cardiac monitoring technology has made prolonged monitoring~     possible with live automatic and patient triggered cardiac rhythm transmission to a central~     monitoring station.~      Objective: To conduct a multicenter two-arm open label RCT among higher-risk (CSARS score≥3)~     ED syncope patients discharged home for comparing the diagnostic yield (detection of serious~     arrhythmias that required treatment or exclusion of arrhythmia) at the end of 15-days between~     a 15-day event monitor (intervention) and usual care (48-hour holter with patients seeking~     care after 48-hours based on symptoms) at 10 Canadian EDs.~      Methods: Cardiophone (live monitor) will be used for the intervention arm and the Mobile~     Cardiac Telemetry (MCT) device will be used for the control arm and both devices applied~     prior to ED discharge. MCT will function as a holter for first 48-hours and then as an event~     recorder (days 3-15) for arrhythmia surveillance. After written informed consent, patients~     will be randomized 1:1 with allocation concealed by web-based randomization and stratified~     based on the total CSARS scores. All patients will be linked to a study cardiologist and will~     have follow-up after 15-days. If serious arrhythmias are detected by Cardiophone, the patient~     will be transported to ED and for non-serious arrhythmias, an interim report sent to the~     study cardiologist for follow-up. All monitoring reports will be sent to the cardiologist~     within 24-hours of completion. Data collection: patient demographics, medical history, score~     predictors, device data (failure, false alarms, duration worn), patient symptoms and comfort.~     Primary outcome will be diagnostic yield at 15-days in the two study arms and primary~     analysis will compare the diagnostic yield by intention to treat principle controlling for~     the stratification factor. Sample Size: 300 patients per arm (600 total) to detect a 10%~     difference in diagnostic yield between the arms.~      Impact: Our study will increase early identification of patients with serious underlying~     arrhythmia by combining the CSARS risk tool with innovative remote monitoring technology.~   "
59586|NCT02786927|"~     This is a Phase IV multi-center, randomized, open-label, cross-over, placebo study in~     subjects with Chronic Obstructive Pulmonary Disease (COPD) to compare inhaler-specific~     preference attributes of two inhalers - ELLIPTA dry powder inhaler (DPI) and the HANDIHALER~     DPI. The primary objective of this study is to evaluate whether more subjects with COPD~     prefer the ELLIPTA inhaler to the HANDIHALER DPI based on the number of steps needed to take~     medication.~      All subjects will use the ELLIPTA inhaler and the HANDIHALER inhaler in the corresponding~     treatment periods based on the randomisation scheme, and at the end of 2 periods, complete~     the inhaler preference questionnaire. Subjects will self-administer the inhalation once daily~     for 5-9 days in each treatment period.~      This study will be placebo-only, and neither inhaler will contain active treatment. Subjects~     will continue their current COPD medication(s) as prescribed, and will follow up with their~     regular physician for their COPD healthcare during the study.~      Approximately 211 subjects will be enrolled in the study.~      ELLIPTA is a trademark of the GlaxoSmithKline group of companies. HANDIHALER is a trademark~     of Boehringer Ingelheim International GmbH.~   "
59587|NCT02786914|"~     Patients with suspected tree-nut or sesame allergy based on sensitization on skin-prick tests~     (SPT), will be assessed for allergy using component analysis and basophil activation test~     (BAT) and entered into oral immunotherapy (OIT). Component analysis and BAT will be repeated~     after completion of OIT. Patients with tree-nut or sesame allergy treated with the standard~     of care of elimination diet will serve as controls~   "
59588|NCT02786901|"~     Loteprednol Etabonate Ophthalmic Gel, (BID and TID) versus Vehicle Group for the Treatment of~     Ocular Inflammation and Pain Following Cataract Surgery.~   "
59589|NCT02786888|"~     Early ambulation after knee replacement surgery is made possible in large part by providing~     safe and effective pain control. Peripheral nerve blocks are increasingly used for~     postoperative analgesia since they can provide excellent pain relief and minimize the need~     for opioid analgesics.~      Ultrasound guided adductor canal block (ACB) was first reported in 2009 by anesthesiologists~     at the University of Utah. This block is unique in that it spares motor function in the lower~     extremity. Since 2009, a number of publications have described the successful use of ACB for~     pain management after total knee arthroplasty (TKA), anterior cruciate ligament (ACL)~     reconstruction, and other procedures of the knee. As a component of multi-modal analgesia,~     ACB can provide effective postoperative pain control and facilitate early hospital discharge.~      Although it is widely utilized, the ACB block can be technically difficult to perform since~     it requires injection in immediate proximity to the femoral artery and vein. In patients with~     a large thigh circumference, ultrasound can be challenging since the femoral vessels are~     deeper and more difficult to visualize. This presents the possibility of vessel trauma and/or~     intravascular injection of local anesthetic.~      The investigators have implemented a new technique for performing the ACB. This block is~     performed using a 20G fenestrated needle. The needle is FDA approved for peripheral nerve~     block. It has an occluded tip with 8 side ports on alternating sides of the distal 2cm.~     Injection through the fenestrated needle produces effective distribution of local anesthetic~     to nerves of the adductor canal without immediate proximity to the femoral artery and vein.~     The ultrasound landmarks used to perform ACB with the fenestrated needle are readily visible~     even in patients with very large thigh circumference.~      In summary, early experience with the US guided ACB block performed with a fenestrated block~     needle suggests that it is technically easier and potentially safer to perform than blocks~     performed with a conventional needle.~      This study should be performed prospectively in order to ensure accurate data comparing the~     two needles. A retrospective review of blocks performed using a conventional needle would not~     provide accurate data with respect to the number of attempts, time required to perform the~     blocks or the resulting sensory changes after performing the nerve block.~   "
59590|NCT02786875|"~     The purpose of this study is to reduce breast cancer recurrence and hence increase~     disease-free survival through a lifestyle program that includes a low glycemic diet, physical~     activity and vitamin D supplementation in women with breast cancer living in a Mediterranean~     country.~   "
59591|NCT02786862|"~     Adequate blood oxygenation and ventilation/perfusion matching should be the main goal of~     anaesthetic and intensive care management. At present, the sole method of improving gas~     exchange restricted by ventilation/perfusion mismatching is independent ventilation with two~     ventilators. Recently, however, a unique device has been developed, enabling ventilation of~     independent lungs in 1:1, 2:1, 3:1, and 5:1 proportions. The main goal of the study was to~     evaluate the device's utility, precision and impact on biomechanical lung parameters during~     thoracic surgery under general anaesthesia with double lumen tube intubation. Secondly- to~     measure the gas distribution in supine and lateral decubitus position.~   "
59593|NCT02786836|"~     The ALFSG-MBT protocol is for a multicenter, open label, non-randomized study to determine~     the value of Breath Identification® (BreathID®) 13C-Methacetin Breath Test System in~     predicting the outcome of patients diagnosed with severe acute liver injury that is not~     related to acetaminophen overdose or acute liver failure who meet inclusion/exclusion~     criteria.~      Up to 200 evaluable patients will be enrolled. An evaluable patient is one who has completed~     one or more breath tests for at least 30 minutes after administration of the 13C-Methacetin~     solution (test substrate).~      The Breath Test will be performed up to five times during the study period on all enrolled~     patients. The first Breath Test will be performed upon admission into the study (Day 1) and~     repeated on Days 2, 3, 5 and 7 provided no contra-indications are present. Each test~     continuously measures changes in the metabolism of the 13C-Methacetin in order to assess the~     improvement or deterioration in liver metabolic function about improvement or deterioration~     in liver metabolic function. If an enrolled non-APAP ALI or ALF patient receives a liver~     transplant, is discharged /transferred from the hospital or dies prior to Day 7, additional~     Breath Tests will not be performed.~      Patients will be contacted for the Day 21 follow up (21 days after enrollment into the trial)~     to determine spontaneous survival, transplantation and occurrence of serious adverse events~     since the patient's last study treatment.~   "
59594|NCT02786823|"~     This study aims to evaluate the effect of Folic acid and Vitamin B12 supplementation on~     Biochemical parameters in subjects with type-2 Diabetes. 80 selected subjects will be divided~     into 4 groups of 20 each.~        -  Group A: to receive Folic acid 5 mg once daily for 8 weeks along with standard oral~          anti-diabetic drugs;~        -  Group B: to receive Vitamin B12 500 mcg once daily for 8 weeks along with standard oral~          anti-diabetic drugs;~        -  Group C: to receive both Folic acid 5 mg once daily and Vitamin B12 500 mcg once daily~          for 8 weeks along with standard oral anti-diabetic drugs;~        -  Group D: to receive no additional intervention apart from standard oral anti-diabetic~          drugs.~      The biochemical parameters will be evaluated before and after the intervention.~   "
59595|NCT02786810|"~     The study will be evaluating the efficacy and safety of a contrast drug in pediatric renal~     ultrasound.~   "
59596|NCT02786797|"~     The purpose of this study is to evaluate MBSR(BC), an intensive meditation-based stress~     reduction intervention, in order to determine its efficacy in improving cognitive functioning~     among breast cancer survivors. The study will employ a three group randomized design that~     will (1) evaluate the extent to which MBSR(BC) compared to the Breast Cancer-Education~     Support (BCES) program or Usual Care (UC) improves cognitive functioning among breast cancer~     survivors off treatment; (2) determine if improvements in cognitive functioning achieved from~     MBSR(BC) are mediated through increased mindfulness and decreased rumination and stress; (3)~     evaluate genetic variants as moderators of MBSR(BC) on improvements in CI; and (4) determine~     the impact of MBSR(BC) on healthcare utilization and costs, in addition it will be delivered~     to a sub-group in Spanish. If shown to be efficacious, the possibility exists of utilizing~     this intervention in other types of cancers as well as non-cancer health-related disorders in~     order to minimize the morbidity experienced by these populations.~   "
59597|NCT02786784|"~     Patellofemoral pain (PFP) is the most diagnosed condition in individuals with knee~     complaints. Studies revealed that one third of individuals with PFP suffer from persistent~     complaints, indicating that current treatments fail to prevent the chronicity of symptoms.~     Considering that current treatment-strategies of patients with PFP seem to be unable to avoid~     the development of chronic symptoms, the question arises if the underlying factors of PFP are~     understood sufficiently. Current research focuses predominantly on muscle strength assessment~     by means of a maximum voluntary contraction (MVC), even though, weakness might not only be~     caused by a reduced voluntary contraction but also by an involuntary ability to contract the~     muscle fully, which is named arthrogenous muscular inhibition (AMI). Although AMI has been~     proven to be present in a wide range of knee joint pathologies to date it remains unclear~     whether patients with PFP are weak or inhibited. It remains also unclear if there exists a~     causal link between AMI and biomechanical alterations.~      Previous studies investigated the influence of exercise treatment on muscular strength,~     function and pain. However, to date no study investigated the influence of the currently~     recommended exercise treatment on AMI. Thus, the analysis of the effect of a 6 week exercise~     treatment might yield further insights if a specific exercise treatment can reduce AMI,~     improve functional performance and reduce pain.~      Methods: The investigators will invite 40 participants with PFP and 40 healthy controls to~     take part in the study. As a basis investigation kinematic, kinetic measures, and surface~     electromyographic (sEMG) of 4 lower limb muscles will be taken during functional tasks.~     Muscle strength and AMI of the quadriceps, muscle flexibility, and a posture assessment of~     the patella as well as the foot will be carried out. All participants with PFP will then~     receive a 6 week exercise programme to follow. After six weeks, the participants with PFP~     will attend the Salford university, where they will be reassessed.~      Expected outcomes: The study will investigate if AMI is present in participants with PFP and~     if AMI is directly linked to functional performance. In addition this study will investigate~     if a specific exercise treatment can reduce AMI and improve functional performance.~   "
59598|NCT02786771|"~     The goal of this study is to evaluate the effectiveness of Spire and Muse on stress~     management. The study will be implemented as a 2-arm randomized controlled pilot study to~     assess the effect of either device on stress management from the end of baseline to closeout.~   "
59599|NCT02786758|"~     This study will offer proof of concept that scaling up treatment for Hepatitis C virus (HCV)~     in individuals co-infected with HIV could lead to elimination of HCV/HIV co-infection in gay~     and bisexual men by treating prevalent infection, thereby reducing new primary infections and~     re-infection.~   "
59600|NCT02786745|"~     To find out the safety and effectiveness of dapsone.~   "
59601|NCT02786732|"~     The purpose of the study is to evaluate the efficacy and safety of Induction and Maintenance~     Regimens of Brodalumab compared with Placebo and Ustekinumab in subjects with moderate to~     severe plaque psoriasis.~   "
59602|NCT02786719|"~     Patients will be asked to participate in this study because patients have been diagnosed with~     high-risk neuroblastoma, a common childhood cancer which has aggressive features. If left~     untreated, high-risk neuroblastoma is fatal. Children with high-risk neuroblastoma often~     respond to current available treatments, but there is a high risk that the cancer will~     return.~      This study will test the safety of giving standard induction treatment for high-risk~     neuroblastoma without one of the drugs commonly used to prevent side effects. Current~     treatment for high-risk neuroblastoma includes anti-cancer drugs (chemotherapy), surgery,~     radiation therapy and high-dose chemotherapy with hematopoietic stem cell rescue. Treatment~     takes about one year to complete and occurs in 3 phases: induction, consolidation, and~     maintenance. This study is limited to the induction phase of treatment.~      Induction therapy includes six chemotherapy drugs given in different combinations every 3~     weeks for a total of 6 courses. For the past decade, induction chemotherapy has been followed~     by a drug called granulocyte colony stimulating factor (G-CSF, filgrastim, peg-filgrastim,~     Neupogen, or Neulasta) to prevent side effects from the chemotherapy. G-CSF is routinely~     given to patients with high risk neuroblastoma after chemotherapy to stimulate white blood~     cell production and shorten the time period when the absolute neutrophil count (ANC), a type~     of white blood cell, is low after chemotherapy. G-CSF is known to shorten the period of low~     ANC by approximately 3 days. When the ANC is lowest, a patient is most at risk of getting a~     bacterial infection.~      Recent lab experiments in mice have shown that neuroblastoma tumor cells may respond to G-CSF~     by growing faster and metastasizing (spreading to other parts of the body). There have been~     no clinical trials comparing the survival of children with high risk neuroblastoma with or~     without G-CSF. This clinical trial is the first step towards giving induction chemotherapy~     with less G-CSF.~      The goal of this study is to determine if it is safe to give induction chemotherapy to~     children with neuroblastoma without giving G-CSF routinely.~   "
59605|NCT02786680|"~     A large body of evidence points to impairment in the decoding of emotional stimuli in~     Parkinson's disease (PD). These changes seem to be related to dysfunction of the~     mesocorticolimbic projections leading to dysfunction of the limbic cortico-subcortical loop~     that, throughout the basal ganglia, projects to limbic cortical regions such as the anterior~     cingulate cortex and the orbitofrontal cortex, which are known to be involved in emotional~     processing. Thus, presumably the occurrence of non-motor psychic symptoms and fluctuations in~     PD would also rely on the degeneration of this circuitry. Dopamine modulation of emotions has~     been frequently reported both in healthy subjects or PD patients, but the effect of~     subthalamic nucleus deep brain stimulation (STN-DBS) over mood symptoms is more controversial~     and there is still a paucity of data demonstrating its role in emotional processing. The~     objective of our study is to assess and compare the behavioral and electrophysiological~     effects of both dopamine and STN-DBS in PD during emotional processing. To do so, the~     Emotional Stroop task, a version of the classical Stroop test developed to investigate~     inhibition of emotional interference, will be performed by STN-DBS PD patients in four~     different treatment conditions while high resolution electroencephalographic cortical mapping~     is conducted. Using this approach, the investigators expect to better separate the mechanisms~     of psychic features related to either disease, dopaminergic treatment, subthalamic~     stimulation or the association of both, with the final aim of optimizing the clinical~     management of PD.~   "
59606|NCT02786667|"~     Clinical description and pathophysiological study of recently diagnosed untreated patients~     with Parkinson's Disease.~      Effect of a dopamine agonist (rotigotine) on apathy in de novo patients with Parkinson~     disease: A controlled, randomized, double blind study.~   "
59607|NCT02786654|"~     The aim of the study is to investigate the association between the use of β blockers and~     mortality among hospital survivors of acute myocardial infarction without heart failure.~   "
59608|NCT02786641|"~     The investigators aim to evaluate the efficiency and toxicities of induction chemotherapy of~     docetaxel, cisplatin and xeloda in nomogram-predicted high risk locoregionally advanced~     nasopharyngeal carcinoma.~   "
59609|NCT02786628|"~     The primary objective of this study is to assess the feasibility of a multi-institutional~     study that collects cardiopulmonary exercise testing and 6 minute walk distance performance~     testing prior to a cycle of chemotherapy (or transplant), followed by collection of patient~     generated health data (wearable activity monitors and patient reported outcomes) for the~     subsequent month. In addition to demonstrating feasibility, the study looks to generate~     preliminary data that supports the capacity of physical performance testing and~     patient-generated health data to complement clinician-rated performance status in patients~     receiving chemotherapy.~   "
59610|NCT02786615|"~     This study addresses the disproportionate representation of men who have sex with men (MSM)~     in the human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS) pandemic~     in Kazakhstan, a country that has seen some of the largest growth in new HIV infections since~     the turn of the century. Using a stepped wedge trial across 4 cities in Kazakhstan, the~     proposed study will test a strategic and innovative social network-based intervention for MSM~     who use drugs in Kazakhstan as a strategy to increase their numbers in the HIV continuum of~     care as well as services that address issues that co-occur with HIV, including drug abuse,~     Hepatitis C Virus (HCV) infection, and other sexually transmitted infections.~   "
59611|NCT02786602|"~     Colorectal cancer (CRC) is a major public health problem in France and worldwide. CRC is the~     third most common cancer in incidence and mortality in France. The vast majority of these~     cancers are adenocarcinomas that arise sporadically and develop from precursor lesions:~     adenoma. All CRC with the same disease stage do not have the same prognosis. Various~     parameters have been identified as factors influencing the prognosis and allows adjustment of~     the treatment. The poor histoprognostic factors are vessels and nerves invasion by the tumor~     or the mucinous adenocarcinoma subtype. At the molecular level, the presence of~     microsatellite instability (MSI) improves the prognosis, while the presence of a BRAF~     mutation is an independent poor prognostic factor.~      The different molecular pathways of colonic carcinogenesis are the chromosomal instability~     pathway, the microsatellite instability pathway inducing errors in DNA mismatch repair and~     the CpG Island Methylator Phenotype (CIMP). The hypermethylation of CpG islands of genes~     promoters leads to an over or most frequently under gene expression. CIMP is observed in near~     15% of CRC and is associated with specific clinical and pathological features: older~     patients, female predominance, right colonic involvement, poorly differentiated or mucinous~     adenocarcinomas. From a molecular point of view, the high CIMP phenotype is strongly~     associated with the presence of BRAFV600E mutation, the absence of RAS mutation and the~     presence of microsatellite instability. The prognostic value of CIMP is actually~     controversial. A recent meta-analysis found that the CIMP phenotype was associated with a~     poor prognosis. Methylation of some genes promoters as CDKN2A is associated with a poor~     prognosis.~      LRP-1 (low density lipoprotein receptor-related protein 1) is a multifunctional endocytic~     receptor that belongs to the LDL receptors the family. It mediates the clearance of many~     extracellular enzymes involved in the spread of cancer cells: metalloproteinases and serine~     proteinases. Decrease of LRP-1 activity or loss of LRP-1 expression correlates with increased~     aggressiveness of cancer cells in certain types of cancer. The expression of LRP-1 has almost~     never been studied in CRC. Only one immunohistochemical study of LRP-1 protein expression in~     colonic adenocarcinoma has been published to date. This study shows that tumor cells express~     LRP-1, but in nearly half the cases, weaker than in normal cells colic. The mechanisms~     involved in the decrease of expression are not known.~      An epigenetic mechanism might be involved as hypermethylation of the of LRP-1 gene promoter,~     especially as the promoter of this gene is rich in CpG islands (methylation targets).~     Clinical and prognostic significance of the LRP-1 gene expression and promoter methylation is~     actually unknown.~   "
59612|NCT02786589|"~     The objective of this study is to evaluate the safety and the effectiveness of Plasmodium~     immunotherapy (blood-stage infection of Plasmodium vivax) for advanced non-small cell lung~     cancer.The treatment will last 3-6 months from the day of successful infection and will be~     terminated by antimalarial drugs.~   "
59613|NCT02786576|"~     This study will assess the effects of adalimumab treatment in moderate to severe Hidradenitis~     Suppurativa (HS) patients in the real world setting. The objectives of this study are to~     estimate the effectiveness of adalimumab treatment on disease severity, to estimate the~     impact of adalimumab treatment on patients' quality of life, psychological effect, work~     productivity and healthcare resource utilization and to describe treatment practices over the~     study period.~   "
59614|NCT02786563|"~     Prospective, post-marketing, multi-center, open-label study to explore if the initiation of~     adalimumab could influence grey-scale (GS) and power Doppler (PD) ultrasonographic (US) score~     using 36-joint plus 4-tendon scoring system, and validate the applicability of different~     simplified US joint scoring systems.~   "
59615|NCT02786550|"~     The combination of Botulinum toxin for crow feet (lateral part of orbicularis oculi muscle)~     and lower blaphaloplasty might have reduces the tension on the end of lower blaphaloplasty~     incision whereas the scar is more visible on patient.~      The main aim of this trial is to investigate whether the injection of Botulinum toxin into~     the bilateral orbicularis oculi muscles could improve the appearance of the scar after lower~     blepharoplasty.~   "
59616|NCT02786537|"~     Phase 1 of this study will compare the effectiveness of 3 approved HCV treatment regimens to~     learn whether they work equally well under real-world conditions. Phase 2 of this study will~     begin early 2017 and will compare the effectiveness of 2 FDA approved HCV treatments.~     Patients receiving HCV therapy in community and academic clinics will be offered the~     opportunity to consent to be randomly assigned to one of three regimens and then observed for~     outcomes. Once randomized, all medical care, laboratory testing, and any disease or side~     effect management will be assumed by usual care conditions, and patient-reported outcomes~     will be collected outside clinic in keeping with pragmatic design principles.~   "
59617|NCT02786524|"~     To evaluate whether formal referral to The Symptom Management and Supportive Care Clinic~     improves symptom burden in advanced stage or recurrent gynecologic oncology chemotherapy~     patients compared with symptom management performed by the primary gynecologic oncologist.~   "
59618|NCT02786511|"~     This is a multi-center, non-randomized, open label, longterm safety and efficacy follow-up~     study for subjects who have been treated with bb2121 in the Phase 1 clinical parent study,~     that evaluated the safety and efficacy of bb2121 in subjects with relapsed or refractory B~     cell maturation antigen (BCMA)-expressing multiple myeloma.~      bb2121 is defined as autologous T lymphocytes (T cells) transduced ex vivo with anti-BCMA02~     CAR lentiviral vector encoding the chimeric antigen receptor (CAR) targeted to human BCMA~     suspended in cryopreservative solution. bb2121 is administered in subjects 1 time (or~     retreated if retreatment criteria are met) in parent clinical study. No investigational~     treatment will be administered in this study.~      After completing the parent study, eligible subjects will be followed for up to 15 years~     after their last bb2121 infusion in the parent study.~   "
59619|NCT02786498|"~     The objective is to determine the effect of vitamin D3 supplementation on fracture healing at~     3 months.~   "
59620|NCT02786485|"~     This is a Phase I, multicenter, open-label, non-randomized study of matched unrelated donor~     BPX-501 T cell infusion in adult subjects with hematological malignancies presenting with~     recurrent disease minimal residual disease (MRD) post-allogeneic transplant.~   "
59621|NCT02786472|"~     The purpose of this randomized intervention pilot is to evaluate the relative efficacy of~     bystander training elements (delivery mode and integration of substance abuse prevention)~     among cohorts of incoming undergraduates at the University of Kentucky, a nationally~     recognized leader in addressing sexual violence through bystander intervention programming.~     Consenting students will be randomized to one of the following training conditions:~        1. In-person Green Dot Intensive Bystander-based Sexual Violence Prevention Training~          (GreenDot);~        2. In-person Green Dot Intensive Bystander Training combined with Substance Abuse~          Prevention Training;~        3. Online Bystander-based Sexual Violence Prevention Training (Haven), and;~        4. Online Substance Abuse Training (AlcoholEdu).~   "
59622|NCT02786459|"~     An exploratory, feasibility and proof-of-concept study to evaluate the capability of a rectal~     probe scintigraphy device (ProxiScanTM) to detect PSMA specific radiopharmaceutical agent~     (ProstaScintÂ®; as a surrogate marker for prostate cancer) in patients who have undergone a~     radical prostatectomy for their disease, patients with multiple negative prostate biopsies~     and patients with known primary prostate cancer. Developed by Hybridyne Imaging Technologies,~     Inc. ProxiScanTM is a small cadmium zinc telluride (CST)-based compact gamma camera. It is~     the same size as a trans-rectal ultrasound (TRUS), currently used for prostate biopsy~     guidance. Men with multiple positive biopsies will be considered controls. Prostate cancer~     sextant biopsy histology results will be correlated with ProxiScanTM, TRUS, MRI and SPECT/CT.~     The investigators hypothesize that it will be safe and feasible to utilize a rectal probe~     scintigraphy (ProxiScanTM) to detect PSMA specific ProstaScintÂ®, thus identifying and~     localizing the tumour sites within the prostate and surrounding areas.~   "
59623|NCT02786446|"~     We want to compare the effect of lignocaine 2 % gel, Naproxen sodium and their combination on~     the pain control during extracorporial shock wave lithotripsy for renal stones.~   "
59624|NCT02786433|"~     Introduction: Parkinson's disease (PD) is a progressive neurodegenerative disorder of~     dopaminergic neurons that can cause some mobility limitations and it has association with~     quality of life (QOL) in patients with PD. Virtual reality (VR) has been used to treat of~     these patients Objective: Evaluate the functional capacity and QOL of individuals with PD~     using VR with X-Box Kinect®. Methods: Were selected 20 individuals classified as stages 1-3,~     aged 50-75 years. They were divided by lot into two groups (control and experimental) with~     ten patients in each. The group (CG) treated with exercises (conventional therapy) during~     five-week, with two sessions per week lasting 60 minutes, while the experimental group (EG)~     spent half the time with conventional physical therapy and other half of time in virtual~     rehabilitation (VR). Subjects were evaluated before and after treatment using the following~     scales: Unified Parkinson's Disease Rating Scale and Parkinson's Disease Questionnaire .~   "
59625|NCT02786420|"~     How environmental pollution contributes to poor pregnancy outcome is poorly understood. The~     first trimester of pregnancy is a particularly vulnerable time period for the developing~     fetus and a mother's exposure to air pollution may alter the way that the placenta is~     established and how it functions throughout the rest of pregnancy. This project aims to~     expand and develop new MRI technologies to assess real-time placental structure and function~     as pregnancy develops from the first to the third trimester so that early detection,~     prevention strategies, and early treatment of placental dysfunction as a result of pollution~     exposures may be developed.~   "
59636|NCT02786277|"~     In this trial, individuals with Acute Kidney Injury will be randomized to usual care or to an~     electronic AKI alert system. In three phases, the alert system will be trained to identify~     those most likely to benefit from the alert, and inclusion criteria will be modified.~   "
59637|NCT02786264|"~     This study proposes to perform a descriptive analysis and pilot observational study looking~     at the types and quantity of anesthetic agents used and their associations with outcomes~     among patients scheduled to receive transfemoral aortic valve replacements (TAVR) at Yale New~     Haven Hospital (YNHH).~   "
60030|NCT02781090|"~     This trial will compare the efficacy of Positively Smoke Free on the Web+ (a smoking~     cessation program + social network for HIV-infected smokers) to the American Heart~     Association Getting Healthy website in promoting abstinence in a group of HIV-infected~     smokers. All participants will be offered a three-month supply of nicotine patches.~   "
59626|NCT02786407|"~     This is a multicenter, double-blind, randomized, placebo-controlled study designed to~     evaluate the efficacy and safety of Botulinus Toxin Type A for Injection (HengLi®) in~     patients with overactive bladder (OAB) . Approximately 216 subjects will be enrolled.~     Subjects will be randomized 2:1 to receive intradetrusor injection of Botulinus Toxin Type A~     for Injection (HengLi®) 100 U or placebo. The study contains two parts: core double-blinded~     phase and extension phase. In the core double-blinded phase, eligible subjects must attend~     three study visits posttreatment 12 weeks. During the extension phase, subjects must also~     attend three study visits (12 weeks). The primary efficacy variables is the change from~     baseline in the daily average frequency of micturition at week 6 after the first treatment.A~     3-day paper bladder diary will be used before each study visits (screening period, the second~     week, the sixth week, the twelfth week, the fourteenth week, the eighteenth week and the~     twenty fourth week ) to collect all OAB symptoms (episodes of urgency, incontinence,~     micturition and nocturia) and volume per voidSafety parameters will also be measured,~     including adverse events, vital signs (pulse and blood pressure) and clinical laboratory~     tests (haematology, serum chemistry and urinanalysis).~   "
59627|NCT02786394|"~     The purpose of this study is to test feasibility for the delivery and perceptions of a~     lifestyle model for middle-aged and older adults by involving participants in its~     development. The goal of the program is to reduce sedentary behaviour, increase physical~     activity, and increase strength and balance. An optional walking program will be run in~     parallel to emphasize the importance of moving more. Participants will be asked to fill out~     questionnaires on course delivery, content and effect throughout the program and 2-3 recorded~     interviews throughout the study. We will collect measurements of physical performance before~     and after the program.~   "
59628|NCT02786381|"~     This clinical study will collect fresh samples and perform laboratory testing on fresh and~     archived samples as described in the protocol.~   "
59629|NCT02786368|"~     This project is a delayed pragmatic delayed-intervention cluster randomized control study in~     a subset of households (n=600) enrolled in a larger scale up program of enhanced homestead~     food production (EHFP) in Cambodia. The trial is designed to evaluate the impact of EHFP~     (home gardens only; home garden and fishponds; home gardens and poultry) versus control group~     on dietary intake of women and youngest child, household food security, income, and~     production throughout the agricultural cycle. Following administration of the baseline survey~     300 households will be randomized to the EHFP package of their choosing (Intervention Group)~     for two years. The other 300 households will not receive any intervention during the first~     year and will act as the control group; data will be collected monthly on production and~     income generated from gardening (and other homestead food production activities) and at two~     points throughout the year 24-hour dietary recall data will be collected from the women head~     of the household (aged 15-49y) and the youngest child between the ages of 6 - 59 months.~     After one year, the control group will be offered the intervention (EHFP package of their~     choice) fully subsidized and the project team will collect identical data on intervention~     group for one year as described for the control group.~   "
59630|NCT02786355|"~     We will conduct this study to show that it is possible to ventilate effectively through a~     Frova bougie and an Ambu® bag.~   "
59631|NCT02786342|"~     Sorafenib represents the standard care for advanced hepatocellular carcinoma (HCC). However,~     molecular predictors of sorafenib efficacy have not yet been identified.~      The primary aim of the study is to validate the prognostic or predictive role of eNOS,Ang2,~     HIF-1, VEGF and VEGFR polymorphisms in relation to clinical outcome (progression-free~     survival, PFS) of HCC patients treated with sorafenib.~   "
59632|NCT02786329|"~     Study aims to compare the influence of TIVA and sevoflurane anesthesia with or without~     lidocaine on postoperative short and long term outcome in patients with colorectal cancer~     undergoing surgery.~      As short term endpoints postoperative pain and opioid consumption, resumption of bowel~     function, PONV, LOS will be registered.~      Long term outcome parameters include: the incidence of chronic pain, 1 and 5 years cancer~     recurrences incidence and mortality.~   "
59633|NCT02786316|"~     Low back pain is a common disorder, occurring worldwide in both males and females in all age~     groups1. The prevalence is higher in females and the incidence peaks between 30 and 65 years.~     It is currently the most frequent musculoskeletal cause of functional disability and it has a~     major socio-economic impact on today's society. Although a small percentage of persons with~     low back pain can be diagnosed with a specific underlying cause, almost 90% of persons with~     low back pain present with symptoms of nonspecific origin. A part of these symptoms are only~     of short duration, but 23% of all people will develop nonspecific chronic low back pain~     (NSCLBP).~      Exercise therapy (ET) is currently an important component in the treatment of NSCLBP.~     Previous studies analysed the effects of various modes of exercise therapy, such as motor~     control therapy, core stability training and aerobic conditioning training. However, therapy~     outcomes can be low, and guidelines in favour of using a specific program are contradictory.~     It thus still remains unclear which therapy modality is best suited. Furthermore, no~     recommendations are available about optimal training intensities during rehabilitation of~     persons with NSCLBP.~      Since as well aerobic as muscular deconditioning are apparent in persons with chronic low~     back pain and improvements in overall physical fitness can affect therapy outcomes in this~     population, ET specifically focussing on physical fitness can be advocated for NSCLBP~     rehabilitation. High Intensity Training (HIT), has been promoted as an effective and~     efficient training method for improving physical fitness and health related parameters in~     healthy persons. Also, HIT resulted in successful reconditioning and improvement of~     functional and disease related outcomes in persons with other chronic diseases such as~     multiple sclerosis, heart failure, COPD and cardiometabolic diseases. Although some studies~     showed promising results for the effect of HIT on low back pain such as high intensity~     isolated, evidence is still scarce and study results are unclear because of methodological~     shortcomings.To evaluate HIT for the rehabilitation of persons with NSCLBP, a therapy program~     was developed consisting of high intensity interval cardio and high load whole body strength~     training.~      The aim of this pilot study is 1) to evaluate the feasibility of a HIT program for the~     rehabilitation of persons with NSCLBP, and 2) to evaluate the effects of a HIT program on~     disease related outcomes and physical fitness compared to a conventional rehabilitation~     program in persons with NSCLBP.~   "
59634|NCT02786303|"~     The diagnosis and the follow-up of neuroendocrine tumors can be difficult to assess,~     especially in the detection of metastasis as they can grow in different organs such as liver,~     lungs, bones or lymph nodes. Nowadays, the diagnosis is made with two main imaging techniques~     which are the thoraco-abdomino-pelvic CT-scan and a scintigraphic method (Octreoscan and~     sometimes a TEP-scan). The use of a whole-body MRI is more and more often used for the~     detection and evaluation of tumors and metastases; therefore, it could be used for~     neuroendocrine tumors. The MRI would allow to replace the two imaging techniques and to avoid~     the use of irradiation but also to have a better detection of metastases. This purpose of the~     study was to evaluate this statement by assessing the consistency between the routine~     techniques and the MRI and finally to update the recommendation if the study is positive.~   "
59635|NCT02786290|"~     This is a First in Human study to assess the feasibility, safety and effectiveness of the~     Zenflow Spring System in relieving the symptoms of obstructive Benign Prostatic Hyperplasia~     (BPH).~   "
59638|NCT02786251|"~     The recent discovery of functional brown adipose tissue (BAT) in humans has led to a paradigm~     shift in adipose tissue biology; it is now believed that adipocytes may play a significant~     role in regulating substrate metabolism. Given that the resurgence in the interest in human~     BAT is still in its infancy, a number of fundamental questions pertaining to the role of BAT~     in human physiology remain unanswered. One area of particular importance, but poorly~     understood, is the potential effect of BAT on triglyceride (TG) metabolism. Data from a~     series of studies have found that BAT is inversely associated with adiposity, high blood~     lipids, and fatty liver in people. However, the role of BAT in the regulation of TG~     metabolism in people is not known. The overall goal of this study is to determine the~     physiological importance of the human BAT in TG metabolism. To this end, we are planning to~     study forty overweight/obese women with high amounts of BAT (BAT+, n=20) and with no/minimal~     BAT (BAT-, n=20) both under thermoneutrality and mild cold exposure (~2 weeks apart). The~     investigators hypothesize that BAT+ subjects will demonstrate greater plasma very low density~     lipoprotein-triglycerides (VLDL-TG) clearance rate during cold exposure compared to BAT-~     subjects and upregulation of genes and proteins involved in lipid metabolism only in BAT (but~     not muscle and white adipose tissue). Infusion of stable isotope tracers and metabolic~     modeling techniques will be used to assess VLDL-TG kinetics. Positron emission tomography~     computed tomography will be used for the identification and quantification of BAT.~     Supraclavicular BAT, abdominal white adipose tissue, and skeletal muscle tissue biopsies~     during cold exposure and thermoneutral conditions in conjunction with molecular biology~     techniques will used to measure expression of genes and proteins involved in lipid~     metabolism.~   "
59639|NCT02786238|"~     This study will be the first clinical trial to examine the impact of two different weight~     loss interventions on novel mechanisms that promote obesity and impede its successful~     treatment, including cognitive function and self-regulatory factors. The results will provide~     important data about how impaired cognitive function and/or self-regulation promote obesity~     and how different weight loss treatments may differentially impact these factors; this~     information will be used to identify promising cognitive and self-regulatory treatment~     targets for preventing further obesity development and for maintaining weight loss.~   "
59640|NCT02786225|"~     Perinatal outcomes in the US rank behind most other developed countries even though women in~     the US utilize more maternity services. Current approaches to consultation and collaboration~     among perinatal care providers, including nurse-midwives, obstetricians, and perinatologists,~     fragment care resulting in communication errors and maternal dissatisfaction. The CARE study~     will test an innovative interdisciplinary consult visit to improve communication, teamwork,~     maternal satisfaction, and perinatal outcomes.~   "
59641|NCT02786212|"~     Cardiac surgery with cardiopulmonary bypass (CPB) provokes a systemic inflammatory response~     that can often lead to dysfunction of major organs. Activation of the contact system,~     endotoxemia, surgical trauma, and ischemic reperfusion injury are all possible triggers of~     inflammation. Previous studies demonstrated that pro-inflammatory cytokines play an important~     role during this process. However, very little is known about the susceptibility of the~     splanchnic organs to ischemic reperfusion injury. Although the incidence of intestinal~     complications reported to be low, the in-hospital mortality in these patients was high at 15%~     to 63%.~      Dexmedetomidine, a highly selective α2-adrenergic agonist, can reduce the consumption of~     other sedative and antinociceptive drugs and provide sufficient sedative effects with minimal~     respiratory side effects. In addition, dexmedetomidine gradually has gained popularity in the~     field of critical care. Preemptive administration of dexmedetomidine has shown to be~     protective against inflammation, intestinal, renal, and myocardial injuries in animal and~     human studies. Dexmedetomidine is also used as an anesthetic adjuvant during surgery to offer~     good perioperative hemodynamic stability and an intraoperative anesthetic-sparing effect.~     Perioperative use of dexmedetomidine can reduce intestinal and hepatic injury after~     hepatectomy with inflow occlusion under general anesthesia. However, whether or not it can~     exert protective effects on the above-mentioned organs, especially intestine, after cardiac~     surgery remains unclear. The aim of this study is to evaluate the effects of dexmedetomidine~     on intestinal, hepatic, and other organ injury in patients receiving cardiac surgery with~     CPB.~      In this double-blinded randomized controlled study, serum diamine oxidase activity, which is~     a sensitive and specific marker for the detection of intestinal injury, is taken as the~     primary endpoint. Other parameters reflecting the functions of liver (AST/ALT), lung (lung~     injury score and CC-16), kidney (BUN/Cre), and heart (CK-MB/Troponin T), the biomarker of~     endothelial injury (endocan) will also be determined. Besides, microcirculation parameters~     measured with Cytocam® and near-infrared spectroscopy (NIRS) will be used to estimate the~     protective effect of dexmedetomidine on microcirculation. The variables will be collected~     perioperatively and will be followed up for 3 days after the surgery. Clinical outcome~     parameters will be followed up for 3 months after the surgery.~   "
59642|NCT02786199|"~     Histological grade of hepatocellular carcinoma (HCC) is an important prognostic factor~     affecting patient survival. It has been divided into four grades from I to IV on the basis of~     histological differentiation. Grade I is the best differentiated consisting of small tumor~     cells arranged in thin trabeculae. Cells with higher grade are larger and less differentiated~     with hyperchromatic nuclei and loss of trabecular pattern.~      Ultrasound is an imaging modality frequently used to evaluate liver tumors because of its~     convenience, real-time, less expensive and no radiation exposure. However, ultrasonographic~     evaluation by conventional B-mode image is semi quantitative and subjective. It still cannot~     replace liver biopsy for the evaluation of HCC.~      This study is aimed to quantify the image characters of B-mode image and the scatterer~     properties using Nakagami distribution. Nakagami parameter is a general model to describe the~     distribution of scatterers. Therefore, the investigators hypothesized that Nakagami parameter~     may also reflect the histological changes in different grades of HCC.~      In this study, the resected HCC tumor samples will be collected from the participants who are~     going to receive surgical resection, and the tumor US images and Nakagami values will be~     obtained via the single-element ultrasound system. The correlation between the ultrasound~     backscatter parameter and the differentiation grade will be analyzed.~   "
59643|NCT02786186|"~     The main purpose of the current study will be to provide real - world evidence regarding the~     safety and effectiveness of secukinumab in the management of patients with moderate to severe~     chronic plaque psoriasis.~   "
59644|NCT02786173|"~     The PRIME Registry is a multi-center, observational study designed to evaluate immediate and~     long-term outcomes (36 months) of endovascular revascularization in patients with critical~     limb ischemia (CLI) and advanced peripheral artery disease (PAD).~   "
59645|NCT02786160|"~     The study is a randomised, placebo-controlled, double-blind, parallel study in obese~     children. A total of 75 obese children in the age 5 to 10 years, enrolled in a childhood~     obesity treatment program, will be included. The participating children will be randomised~     into one of three groups consuming either HMO (two groups) or placebo (one group).~      The primary objective of the study is to establish the effects of HMOs on the faecal~     microbiota in children. Secondary objectives are to evaluate safety of HMO supplementation in~     children and the effect on gastrointestinal symptoms (tolerance), bowel habits, metabolic~     profile and body composition in obese children.~   "
59658|NCT02785991|"~     The purpose of this registry is to reflect on standard clinical practice in pulmonary vein~     cryoablation in Spanish hospitals, the different procedure protocols, details of~     intervention, complications, long-term follow-up strategy and results in these subjects.~   "
71181|NCT02635282|"~     The general objective of this study is to determine whether intranasal ketamine should be~     incorporated into formulary as an option to treat pain during minor procedures in the~     pediatric emergency department.~   "
59646|NCT02786147|"~     The purpose of this study is to identify the most effective means of follow-up for women who~     screen positive on B-RST (Breast Cancer Genetics Referral Screening Tool) applied in the~     standard clinical setting of mammography, to maximize the number who are referred to and~     receive cancer genetic counseling services. The clinical utility of B-RST 3.0 will also be~     evaluated by determining the number seen who are appropriate for genetic testing, undergo~     genetic testing and are found to carry a hereditary cancer gene mutations with medical~     management implications for the patient and family. The long-term goal is to reduce the~     morbidity and mortality associated with hereditary causes of breast and ovarian cancer among~     patients seen in the Emory/Winship system.~   "
59647|NCT02786134|"~     Coronary flow reserve (CFR, calculated as the ratio of hyperemic over rest myocardial blood~     flow) is emerging as a powerful quantitative prognostic imaging marker of clinical~     cardiovascular risk. CFR provides a robust and reproducible clinical measure of the~     integrated hemodynamic effects of epicardial coronary artery disease (CAD), diffuse~     atherosclerosis, and microvascular dysfunction on myocardial tissue perfusion. Inflammation~     is a key mediator of this constellation of abnormalities, affecting the entire coronary~     vasculature, but no clinical trial to date has shown that directly reducing inflammation~     lowers cardiovascular event rates. As such, the recently launched Cardiovascular Inflammation~     Reduction Trial (CIRT) provides a unique opportunity for mechanistic investigation of the~     impact of anti-inflammatory therapy on changes in CFR as a reflection of coronary vascular~     dysfunction, which may precede clinical outcomes, particularly in patients at high-risk of~     events. The investigators are ideally positioned to examine the impact of inflammation on~     CFR, having extensive experience in both the quantitation of CFR using clinically-integrated~     dynamic positron emission tomography (PET) and the ability to assess its association with~     cardiovascular outcomes. The central hypothesis of this ancillary proposal, CIRT-CFR, is that~     reducing systemic inflammation using low-dose methotrexate (LDM) will, compared to placebo,~     quantitatively improve myocardial blood flow and coronary flow reserve as measured by PET~     over one year, in stable CAD patients with type 2 diabetes or metabolic syndrome enrolled in~     CIRT. In so doing, improvement in coronary vasoreactivity, endothelial function, and tissue~     perfusion may have beneficial effects on myocardial mechanics, left ventricular deformation~     and function and, ultimately, symptoms and prognosis.~   "
59648|NCT02786121|"~     Several authors explain as the kinesiophobia plays an important role for the recovery after~     orthopaedic surgery. The aim of the investigators study is to investigate if the~     kinesiophobia is able to influence the early recovery after total hip arthroplasty. The early~     recovery will be measured by the ILOA Score. The Tampa Scale of Kinesiophobia will measure~     the fear level of movement. All the other variable that could influence the ILOA Score are~     identified and collected: age, sex, body max index, ability of patient pre-surgery, type of~     anesthesia, length of stay, pain, haemoglobin, possible complications.~   "
59649|NCT02786108|"~     The purpose of this study is to evaluate the safety and effectiveness of left gastric artery~     embolization(bariatric arterial embolization) for morbid obesity. When the target vessel is~     blocked, some of the body's signals for feeling hungry will be suppressed and lead to weight~     loss.~      Although there are many ways to treat morbid obesity, surgery is currently the only effective~     method to be confirmed. But surgical treatment is likely to carry a high risk of~     treatment-related complications, such as fistula or intestinal obstruction, etc. This study~     is designed to help treat obesity using a method of transvascular interventional therapy,~     which is minimally invasive and non-surgical.~   "
59650|NCT02786095|"~     This study is prospective Cohort study which was performed in multicenter (General Hospital)~     in Korea. Inclusion criteria is all patients with atrial fibrillation who visit hospital. The~     purpose is to analyze complication, composite outcome (all cause mortality, hospitalization,~     the incidence of stroke, heart failure and cardiovascular event (MACE)) according to the 1)~     the use of anti-arrhythmic drugs (AADs), 2) use of medication for rate control (beta blocker,~     calcium channel blocker and digoxin) and 3) use of anticoagulation agents (warfarin,~     coumadin, an NOAC)~   "
59651|NCT02786082|"~     The main objective is to study the pharmacokinetics of Azilsartan Tablets in human and~     providing evidence for clinical study and clinical application of this product.~   "
59652|NCT02786069|"~     The main objective is to evaluate the effect of single dose Propionyl-L-Carnitine~     Hydrochloride on clinical pharmacokinetic characteristics and its effect of clinical~     pharmacokinetic characteristics and safety on healthy Chinese subjects to provide a basis for~     market authorization registration.~   "
59653|NCT02786056|"~     Structural lung and airway alterations in CF lead to focal or heterogeneous abnormalities in~     regional lung ventilation. The quantitative assessment of structural and functional~     alterations in the lung is of great importance for the phenotyping and follow-up of CF~     patients. The goal of this study is to assess the feasibility of measuring the changes in~     proton density in the lung parenchyma with inflation and deflation during the respiratory~     cycle, using ultrashort echo time (UTE) pulse sequence MRI, in healthy adult volunteers.~   "
59654|NCT02786043|"~     The main objective is to evaluate the effect of Propionyl-L-Carnitine Hydrochloride on~     clinical pharmacokinetic characteristics and its effect of clinical pharmacokinetic~     characteristics and safety on healthy Chinese subjects to provide a basis for market~     authorization registration~   "
59655|NCT02786030|"~     This study will evaluate a complex intervention based on a patient management tool (PMT),~     combined with educational outreach to primary care doctors, nurses and other health workers,~     in the Brazilian city of Florianopolis. The intervention is aimed at improving the quality of~     respiratory care and respiratory health outcomes, and comorbid conditions, in adults with~     asthma and chronic obstructive pulmonary disease (COPD). The effectiveness of the~     intervention will be assessed by randomly allocating 48 primary care clinics to receive the~     intervention or not, and comparing patient and clinic level endpoints that reflect the health~     and quality of care provided over the following year. About 1250 patients known to have been~     diagnosed with asthma and 700 with COPD in participating clinics and will be included in the~     study. The primary endpoints for patients with asthma and COPD, respectively, will be~     composite scores indicating appropriate prescribing and diagnostic testing. The third primary~     endpoint, among all adult clinic users, will be rates of new diagnoses of asthma and COPD in~     each clinic. Secondary endpoints will include the individual components of the composite~     scores, health measures (hospital admissions and deaths), and indicators of appropriate~     management of comorbid conditions such as cardiovascular risk factors. Eligible patients will~     be identified and outcomes measured using electronic medical records.~   "
59656|NCT02786017|"~     The purpose of this study is to assess the safety and efficacy of injectable collagen~     scaffold combined with human umbilical cord-derived mesenchymal stem cells (HUC-MSCs)~     transplantation in patients with Decompensated Cirrhosis.~   "
59657|NCT02786004|"~     This study is being conducted to determine the image quality of images using a new~     investigational medical imaging device.~   "
59661|NCT02785952|"~     This randomized phase III trial compares nivolumab with ipilimumab and nivolumab alone in~     treating patients with stage IV squamous cell lung cancer that has come back after previous~     treatment. This is a non-match sub-study that includes all screened patients not eligible~     for a biomarker-driven sub-study. Monoclonal antibodies, such as nivolumab and ipilimumab,~     may be able to shrink tumors. It is not yet known whether nivolumab works better with or~     without ipilimumab in treating patients with squamous cell lung cancer.~   "
59662|NCT02785939|"~     This phase II/III trial studies how well palbociclib works in treating cell cycle gene~     alteration positive patients with stage IV squamous cell lung cancer that has come back after~     previous treatment. This is a sub-study that includes all screened patients positive for cell~     cycle gene alterations which can cause tumor cells to grow more quickly. Palbociclib may slow~     cell cycle progression and may be able to shrink tumors.~   "
59663|NCT02785926|"~     During pregnancy, the foetus is therefore chronically exposed to a large number of~     substances. A number of studies have started to emphasize the effects of this antenatal~     exposure on the newborn infant's morphological parameters (weight, crown-rump length, etc.).~     However, in addition to these morphological effects, pesticides may also induce various~     effects on physiological functions, as some pesticides act as inhibitors of neurotransmitters~     involved in many nervous system regulation pathways in man. This is particularly the case for~     organophosphates, which act as acetylcholinesterase inhibitors. A previous study conducted by~     the coordinator of the project presented here demonstrated the presence of high levels of~     this type of pesticide in meconium (1st stool) in neonates born in Picardy. This inhibition~     of the enzyme metabolizing ACh could have an impact on neurophysiological functions mediated~     by this neurotransmitter. Sleep or respiratory control, vital functions of the neonate~     particularly in preterm neonates, could therefore be affected.~      The PhysioMéco project is therefore designed to study the possible links between antenatal~     exposure to pesticides and modifications of respiratory control allowed by peripheral~     chemoreceptor in preterm neonates. Antenatal exposure will be determined by pesticide assays~     in the meconium of neonates in combination with an exposure questionnaire to determine the~     sources of these pesticides. Sleep and respiratory control will be studied in these neonates~     nursed in incubators. Hypoxic test will be used in order to assess respiratory control~     involving the peripheral chemoreceptors.~   "
59664|NCT02785913|"~     This phase II trial studies how well taselisib (GDC-0032) works in treating patients with~     stage IV squamous cell lung cancer that has come back after previous treatment. This is a~     sub-study that includes all screened patients positive for the phosphoinositide 3-kinase~     (PI3K) biomarker. PI3K can cause tumor cells to grow more quickly. Taselisib may decrease the~     activity of PI3K and may be able to shrink tumors.~   "
59665|NCT02785900|"~     The purpose of this study in AML patients is to test whether vadastuximab talirine~     (SGN-CD33A; 33A) combined with either azacitidine or decitabine improves remission rates and~     extends overall survival as compared to placebo combined with either azacitidine or~     decitabine.~   "
59666|NCT02785887|"~     This is a randomized parallel group trial designed to evaluate the impact of implementing~     geriatrician-prescribed interventions based on the comprehensive geriatric assessment (CGA),~     on the ability to deliver adequate chemotherapy treatment, as measured by relative dose~     intensity (RDI).~   "
59667|NCT02785874|"~     Statin is a preventive medicine for hepatitis B and hepatitis C which decreases the risk~     turning into liver cancer,however, the investigators also discovered that patients taking~     Statin live longer than patients who didn't take Statin in the incidence of liver cancer~     death cases.~   "
59668|NCT02785861|"~     After treatment, women want to regain a 'normal' lifestyle while some factors interfere as~     chronic fatigue. In the absence of anemia, fatigue is often a consequence of physical~     deconditioning . The following protocol will focus at this problem.It will consist of a brisk~     walking program twice a week over a period of 6 weeks, at an intensity of 60% of HR pic~     during 20 minutes.~   "
59669|NCT02785848|"~     The investigators will explore barriers to improving self-efficacy, or the ability to feel in~     control of their disease, and medication adherence with text messaging through surveys and~     interviews with adolescents and adults with SCD cared for at the Vanderbilt Meharry Center of~     Excellence (VMCE) in Sickle Cell Disease (SCD). The investigators will identify preferences~     to improve and sustain adherence to daily medication through selection of~     investigator-proposed or patient-generated text messaging strategies. Finally, the~     investigators will fill in the literature gaps by describing barriers to self-efficacy and~     medication adherence among adults with SCD as well as adolescents with SCD who are~     transitioning to adult care.~   "
59670|NCT02785835|"~     Observational study. All HIV-infected patients who have been diagnosed of hepatocellular~     carcinoma (HCC), following the American Association for the Study of Liver Diseases (AASLD)~     criteria, in the participant centers are included. Epidemiological, clinical and laboratory~     data are collected. The clinical and epidemiological characteristics of HCC cases will be~     analyzed. The efficacy and outcomes after modalities of HCC therapy will be assessed.~     Mortality and its predictors will be also assessed. In those cases infected by hepatitis C~     virus (HCV), the impact of HCV therapy on outcomes will be analysed.~   "
59671|NCT02785822|"~     Polycystic ovary occurs in 15-20% of the population will be submitted to TRA. Whether it is~     associated with other signs or symptoms (polycystic ovarian syndrome) as if presented in~     isolation, its therapeutic management has special connotations sometimes favoring the low~     response although the standard is the tendency to hyperresponsiveness.~      Although there are studies comparing the combination of FSH and LH and FSH in controlled~     hyperstimulation of these patients, there are no previous prospective randomized studies~     comparing administration of urinary FSH (hFSH-HP) with a combination of FSH and HCG (HMG HP).~      Therefore the aim of this study is to prove that both drugs are comparable in the treatment~     of these patients. The test substances are marketed in Spain (Fostipur and Meriofert,~     respectively) with an indication for use in these patients. In this study both medicines will~     be administered in a randomized way under the usual conditions in which it is used in routine~     clinical practice to compare the quantity of mature oocytes respect to the total oocytes~     obtained, as a primary outcome measure.~   "
59672|NCT02785809|"~     The aim of this study is to investigate whether there is a correlation between anti-Müllerian~     hormone during long-term use of combined oral contraceptives and the recovery time before~     recovered menstrual cycle after discontinuation of oral contraceptives.~   "
59673|NCT02785796|"~     In osteopathy is generally believed that the cranial bones are equipped with an inherent~     mobility, which like any other joint may face restrictions on movement and then somatic~     dysfunction. For this reason, different techniques are used with the aim of increasing the~     mobility of the cranial bones. Some of these have been effective in modifying physiological~     parameters related to the activity of the autonomic nervous system, such as cardiac function~     or sleep latency. This study aims to test the effectiveness of a specific craniosacral~     technique, compression of the fourth ventricle CV4, using the salivary marker alpha amylase,~     which is sensitive to changes in the activity of the autonomic nervous system. To patients~     recruited from students of AIMO, we will ask to provide saliva samples before and after CV4~     treatment. In particular, saliva will be collected four times per patient: at the initial~     time, after administration of a stressful event (hand immersion in ice water), immediately~     after application of the CV4 technique and thirty minutes after the application of the CV4~     technique. For each sample of saliva detected, we will proceed to measure the activity of~     alpha amylase and flow rate, variables sensitive to the activation of the autonomic nervous~     system.~   "
59674|NCT02785783|"~     This study evaluates the impact of Endorings™ assisted colonoscopy on the number of polyps~     detected per patient compared to standard colonoscopy without use of EndoRings™. Half of the~     participants will receive EndoRings™ assisted colonoscopy, while the other half will receive~     standard colonoscopy.~   "
59675|NCT02785770|"~     This is a study designed to ascertain the effect of PF-04447943 on QT interval in healthy~     adult subjects. This is conducted as part of standard drug development.~   "
59676|NCT02785757|"~     Patients with cancer are at particularly high risk of venous thromboembolism (VTE). The~     guidelines therefore strongly recommend thromboprophylaxis but recent surveys clearly show~     that oncologists are reluctant to use it because of concern over bleeding, absence of~     validated risk stratification tools and uncertainties concerning the optimal~     thromboprophylaxis. Hence, it is a real challenge to identify the individual VTE risk of each~     cancer patient and individually tailor their thromboprophylaxis.~      The study aims to identify thrombin generation test (TGT) as a reliable, standardized overall~     haemostasis assay that can be used to evaluate individual thrombosis risk~      The secondary objectives are:~        -  To define the limits of TGT parameters that indicate thrombosis risk in cancer patients~        -  To evaluate values of other clotting activation markers in patients with cancer~      Patients recently diagnosed with locally advanced or metastatic adenocarcinoma of any origin,~     who are scheduled for systemic chemotherapy, will be enrolled in the trial at baseline (Visit~     1). Thrombin generating capacity will be measured within the first month following diagnosis~     and before the start of the chemotherapy (between Visit 1 and Visit 2) and subsequently at~     the end of the first cure line of chemotherapy (Visit 3). Patients will be followed up for a~     period of 1 year, or until the occurrence of a thromboembolic event. Two follow up visits are~     foreseen - 6-month (Visit 4) and 12-month (or at the end of trial - Visit 5) visits.~      Patients eventually undergoing second-line chemotherapy during the course of the follow-up~     will remain on study.~      The study will document all cases of symptomatic thromboembolic events together with the~     relevant diagnostic work-up.~   "
59677|NCT02785744|"~     Gaucher disease is a most common genetic metabolic disease characterized by low platelet~     number, liver and spleen enlargement and various forms of bone diseases including low bone~     mineral density leading to brittle bones. Various treatment options are now available for~     this disease.~      The purpose of this research study is to determine the prevalence of Gaucher disease in~     patients with low bone mineral density as observed by DEXA scan, which is a form of X-Ray of~     the bone.~   "
59678|NCT02785731|"~     ANGLE has developed the Parsortix™ Cell Separation System (Parsortix), an automated system~     capable of harvesting rare circulating cells for analysis from a sample of peripheral blood~     based on cellular size and deformability. In a small pilot study, scientists at the Medical~     University of Vienna demonstrated that measurement of a combination of mRNA markers extracted~     from CTCs captured using the Parsortix system could be used to identify women with ovarian~     cancer. This study is designed to provide specimens for optimization of an assay using~     clinical and biomarker information (i.e. demographics, imaging results and/or serum tumor~     markers) in combination with mRNA extracted from rare cells in the blood of women presenting~     with a pelvic mass for the detection of malignancy.~      Primary Objective: Optimization of an assay for the differentiation of women with benign~     pelvic masses from those with malignant pelvic masses using mRNA markers extracted from CTCs~     isolated from whole blood. Multiple serum tumor markers and mRNA markers will be measured,~     and the results will be compared to the actual clinical diagnosis made for each patient~     through other recognized methods (e.g. histopathology). The blood samples collected in the~     course of this study will be used to finalize the selection of mRNA and/or serum tumor~     markers to be evaluated in future prospective studies.~      Exploratory Objective: Use statistical modeling to determine the need for and/or preliminary~     design of a mathematical algorithm to combine the multiple serum tumor and/or mRNA markers~     for estimation of the risk of ovarian cancer.~   "
59679|NCT02785718|"~     Cardiovascular diseases are important causes of morbidity and mortality in the industrialized~     world. Abnormalities in the coagulation system, causing a hypercoagulable state, are a known~     risk factor for arterial and venous thrombosis. The contact activation system is part of the~     coagulation system and consists of four proteins: coagulation factor XII (FXII), FXI,~     prekallikrein and high molecular weight kininogen (HMWK). Clinical studies indicate an~     important role for the contact activation system on the risk of arterial thrombosis.~     Furthermore, there is substantial evidence from mouse studies that FXII and FXI participate~     in the formation and stability of thrombi. In vitro studies show that collagen, present in~     the vascular wall, is able to activate FXII and hereby stimulate thrombin formation and~     potentiate the formation of platelet-fibrin thrombi and FXIIa is able to change the structure~     of fibrin clots by binding to fibrin(ogen) and by generation of additional thrombin. However,~     the contact system also participates in the process of fibrinolysis, which degrades thrombi.~      The investigators would like to investigate the contribution of the contact activation system~     to the formation of thrombi. The formation of a thrombus within the vascular bed is the main~     cause for occlusion of an artery or vein, which can lead to an infarct such as a heart~     attack. Due to the other functions of the contact system it is important to fully understand~     how the contact system contributes to thrombus formation, before it can be used as a target~     in the treatment of arterial thrombosis. The aim of this study is to determine the~     contribution of the proteins of the contact system, mainly FXII and FXI, in the platelet~     mediated formation and degradation of thrombi. This will be studied in flow models~     (perfusion-flow model and Chandler loop), in a static model (ROTEM®) and using thrombin~     generation assay.~   "
59680|NCT02785705|"~     Type 2 component of oral poliovirus vaccine is slated for global withdrawal through a switch~     from trivalent oral poliovirus vaccine (tOPV) to bivalent oral poliovirus vaccine (bOPV) for~     preventing paralytic polio caused by circulating vaccine-derived poliovirus type 2. We aimed~     to assess immunogenicity and safety profile of six vaccination schedules with different~     sequential doses of inactivated poliovirus vaccine (IPV), tOPV, or bOPV.~   "
59681|NCT02785692|"~     Postoperative wound healing complications following preoperative radiotherapy represent a~     severe problem in the treatment of malignant soft tissue tumors, and are reported to be 34%~     and more. The literature discusses intensely the advantages and disadvantages of this~     multimodal treatment concept and there are different opinions. The Canadian prospective~     randomized NCIC SR2 trial showed increased wound complication rates in the study arm~     receiving preoperative radiation. The Sarcoma Center Zurich pursues mainly this treatment~     concept and the results shall now be analysed and published. The approach is to show that not~     only the complication rates are comparable to international bench marks, but also the (still~     intermediate time) local control rates.~   "
59682|NCT02785679|"~     Cow's milk protein (CMP) allergy is one of the most common food allergies and potentially a~     fatal one. Early feeding with CMP has been considered in the past as a risk factor for~     development of CMP allergy in high risk infants. Although other studies argue with this~     assumption and suggest early exposure to CMP might be protective against atopic dermatitis~     and CMP allergy. A cohort study that first introduction of CMP after 15-30 days of age,~     raised the risk for CMP allergy.The aim of this study is to investigate if early and~     continuous exposure to CMF will decrease CMP allergy rate.~   "
59683|NCT02785666|"~     The investigators aim at investigating the efficacy of grazoprevir/elbasvir ±ribavirin in~     HIV-positive MSM participating in the SHCS in a broader setting of coinfected MSM. The study~     pursues a comprehensive approach of a treat, counsel and cure strategy exploring the impact~     of such a strategy in a representative HIV/HCV-coinfected MSM population. This study is a~     nested project of the Swiss HIV Cohort Study entitled The Swiss HCVree Trial.~   "
59684|NCT02785653|"~     This study evaluates the potentiation of muscle relaxation caused by rocuronium by~     inhalational agent sevoflurane. Half the patients will be ventilated with oxygen ,nitrous~     oxide and sevoflurane during induction of anaesthesia and half will be ventilated only with~     oxygen and nitrous oxide.~   "
59685|NCT02785640|"~     This dual-arm randomised study aims to test a multi-component intervention to reduce~     sedentary behaviour in a cohort of desk-based office workers.~   "
59686|NCT02785627|"~     The ANTELOPE trial is a longitudinal observational clinical study of changes in bone density,~     structure and strength over 12 months in men receiving treatment for prostate cancer. Three~     groups (n = 30 per group) will be compared, with bone assessments at baseline and 12 months.~     Allowing for a 18 month recruitment period, 12 months follow-up and data analysis, the total~     study length will be 3 years. The groups comprise:~      Group A - Men with prostate cancer starting ADT~      Group B - Men with newly diagnosed hormone sensitive metastatic prostate cancer, about to~     start (or have started within the past 3 months) ADT and who will undergo chemotherapy with~     docetaxel and prednisolone~      Group C - Age-matched men without prostate cancer~   "
59687|NCT02785614|"~     The main objective is to evaluate the pharmacokinetics comparative studies in a single dose,~     multiple dose~   "
59688|NCT02785601|"~     The main objective is to compare the pharmacokinetics in single dose, and effect of food on~     the trazodone hydrochloride pharmacokinetics prolonged-release tablets.~   "
59689|NCT02785588|"~     This study investigates a novel magnetic resonance imaging (MRI) system designed by GEHC for~     imaging viable neonate and infant populations. This MR system has a smaller size and design~     features that may make it more feasible to locate the system in close proximity to care areas~     for neonates (birth - 1 month) and infants (>1 month to two years), such as clinical neonatal~     intensive care units (NICUs) and other infant and neonatal care departments.~   "
59690|NCT02785575|"~     The study will compare a novel calculation model (HeProCalc AB) with a standard weight-based~     and activated clotting time adjusted calculation for the dosing of Heparin and protamine and~     assess the impact on postoperative bleeding and blood transfusions after cardiac surgery.~   "
59691|NCT02785562|"~     Epidemiologic multicenter prospective study in advanced NSCLC patients with PDL1 expression :~     evaluation of clinical and pathological characteristics of PDL1 high expression patients~     compared to patients with a weak or no expression of PDL1.~   "
59692|NCT02785549|"~     Patients with mild acute diverticulitis (modified Neff 0 grade), following the inclusion~     criteria and giving informed consent, will be included in the study protocol and will be~     randomly assigned to one of the treatment arms: symptomatic treatment with NSAID plus~     antibiotic vs symptomatic treatment with NSAID only. They will be followed-up at 48 hours, 7~     days, 30 days and 3 months from the onset of the episode.~   "
59693|NCT02785536|"~     Tobacco use is a leading contributor to racial and socioeconomic health disparities in the US~     primarily due to an unequal burden of tobacco-related disease from a disproportionate share~     of smokers in African American and lower socioeconomic (SES) groups. Unlike many other health~     risk behaviors, tobacco-related health disparities are increasing despite a large treatment~     network of free telephone and in-person counseling services, perhaps due to significant~     disparities in treatment outcomes. The goal of this project is to revise the standard~     treatment for tobacco dependence to address key factors associated with treatment outcome~     disparities and more fully meet the needs of lower SES and African American smokers thereby~     reducing socioeconomic disparities in tobacco dependence treatment outcomes, halting the~     alarming increase in tobacco-related health disparities, and reducing a leading cause of~     racial and socioeconomic health disparities in the US.~   "
59694|NCT02785523|"~     A phase III double-blind randomized clinical trial on the effects of ganoderma spore lipids~     to the immunological response in patients with G.I. Cancers. The trial is randomized,~     double-blind. Cancer patients are diagnosed based on pathology or cell biology. Patients are~     randomized into 2 groups: both groups receive chemotherapy. Either group receives ganoderma~     spore lipids or placebo capsules 600mg three times a day (TID) in addition to the~     chemotherapy. Clinical evaluation includes chemotherapy drug toxicities, life quality~     improvement. Blood biochemistry tests mainly include malondialdehyde (MDA), superoxide~     dismutase (SOD), glutathione peroxidase (GSH-Px), adrenaline, nor-adrenaline, tumor necrosis~     factor (TNF)-α, interleukin (IL)-1b, interleukin (IL)-6, cell flow cytometry on Th1, Th2,~     Th17, Treg cytokines, as well as serum cortisol, estradiol (female), progesterone (female),~     testosterone (male), etc.~   "
60031|NCT02781077|"~     In an observational study, the energy consumption of stroke individuals during performing the~     structured, progressive task-oriented exercise program for walking rehabilitation will be~     measured in order to confirm the intensity demand in the range of moderate to vigorous.~   "
59695|NCT02785510|"~     Parkinson's disease is the second most common neurodegenerative disease affecting about 1-3%~     of population above 60 years. Recently, non-motor symptoms are getting more attention in PD~     management. The pattern of PD onset and clinical course differ from one population to~     another. Many studies have been conducted to determine the clinical profile of PD in~     populations worldwide. However, no similar studies have been conducted in Egypt. Therefore,~     the investigators will conduct a nation-wide, collaborative, cross sectional study to~     determine the pattern of Parkinson's disease onset, clinical course, and non-motor symptoms~     among Egyptian population.~   "
59696|NCT02785497|"~     Skin lesions, such as chronic ulcers and burns, represent a serious public health problem due~     to high government costs, and scarce successful conservative treatments.There is a growing~     scientific literature on the use of electrotherapy in the process of wound healing, but in~     return there is a dearth of scientific studies on the use of various types of currents and~     the different parameters in the proposed treatments.~   "
59697|NCT02785484|"~     The purpose of this randomized controlled trial is to determine whether constituent~     disclosures on cigarette packs increase intentions to quit smoking. Previous studies have~     been informative, but they have evaluated candidate graphic warnings, not constituent~     disclosures. Furthermore, they typically expose participants to messages in controlled but~     artificial experimental settings for a short period of time, using much lower frequency and~     shorter duration of message exposure than found in the real world. This study addresses these~     issues by evaluating the impact of constituent disclosures by randomly assigning smokers to~     have their cigarette packs labeled with constituent disclosure messages or cigarette butt~     littering messages.~   "
59698|NCT02785471|"~     The purpose of this study is to test a comprehensive, male-oriented, online screening and~     referral (Screening for Mental Health; SMH) and male-oriented online information and referral~     intervention program (Man Therapy; MT) to improve mental health and wellbeing with a focus on~     prevention of suicide and help-seeking behaviors among middle-aged men. The online programs~     will be offered together to maximize the effect on reducing suicide behavior and increasing~     mental health help-seeking behaviors for men. If successful in decreasing suicide behavior~     and ideation and increasing suicide help-seeking behavior, this intervention could be scaled~     up to contribute to a reduction in suicide behaviors and deaths across the country.~   "
59699|NCT02785458|"~     This study evaluates the effectiveness of an electronic health record based educational~     intervention (the EMC2 strategy) to improve patient understanding and use of higher-risk~     medications. Half of the participants will receive the intervention, while the other half~     will receive the usual amount of information (usual care).~   "
59700|NCT02785445|"~     The objectives of the Healthy.io Method Comparison and User Performance Study are:~        1. To evaluate the performance of Dip.io Device in comparison to the ACON U500 Mission®~          U500 Urine Analyzer.~        2. To evaluate the user performance of Dip.io Device under actual use conditions (home~          environment) based on a user questionnaire and rating scale.~   "
59701|NCT02785432|"~     1. Examine the use of low level therapeutic laser (LLLT) combined with physical therapy for~          improvements in pain, range of motion, and function in individuals with chronic pain~          from musculoskeletal conditions.~        2. Compare changes in pain, mobility, and ability to return to home/work/recreational~          activities between treatments with standard physical therapy plus LLLT or the standard~          physical therapy program alone.~   "
59702|NCT02785419|"~     After stroke, individuals often have persistent difficulty using the arm and hand in everyday~     functional tasks that reduces quality of life. Currently available rehabilitation techniques~     are not adequate and new protocols are needed that are based on an understanding of how brain~     regions work together to produce skilled movement. This research project aims to improve our~     understanding of how the brain controls movement after stroke and determine whether a period~     of motor practice that targets specific brain regions through the addition of action~     selection demands leads to improved arm function. We hypothesize that arm motor function and~     the ability to efficiently activate the action selection motor circuit during movement will~     improve after training.~   "
59703|NCT02785406|"~     The purpose of this study is to determine the effectiveness of a medication called suvorexant~     in reducing anxiety, improving sleep, and reducing cocaine cravings or cocaine use.~   "
59704|NCT02785393|"~     The purpose of the study is to asses the potential interactions between methamphetamine and~     doxazosin in methamphetamine-dependent volunteers who are not seeking treatment. The study~     will evaluate the effects of doxazosin on the cardiovascular and subjective effects of~     methamphetamine in a human laboratory study.~      The primary objective is to determine the safety of treatment with doxazosin in~     methamphetamine-dependent volunteers by examining hemodynamic and subjective effects of~     administration of ascending doses of methamphetamine and a placebo dose during treatment with~     doxazosin.~      The secondary objective is to determine effects of treatment with doxazosin, as compared to~     placebo, on subjective effects produced by administration of methamphetamine or placebo~   "
59710|NCT02785315|"~     People with mild cognitive impairment (MCI) are at a greater risk of developing dementia.~     Therefore, it is important to develop effective non-pharmacological interventions to~     facilitate their cognitive and activities of daily living (ADL) function, which will also~     prevent or delay their progression to dementia and reduce associated healthcare and social~     costs. There are currently a variety of cognitive interventions, mainly categorized as~     remediation and rehabilitation approach. Research to compare their contents and effectiveness~     is strongly needed. The information can be used to individualize cognitive intervention based~     on specific cognitive profile of the patient.~      This study aims to determine the immediate and long-term efficacy of the remediation approach~     and rehabilitation approach in enhancing the cognitive and ADL function. The research~     questions include 1) whether the rehabilitation approach compared with the remediation~     approach has better effects on improving ADL function; (2) whether the remediation approach~     may only enhance the performance on the cognitive tests rather than on the ADL function. This~     study will also explore whether the attitudes of caregivers on providing ADL assistance~     affect effects of cognitive intervention.~   "
60294|NCT02777645|"~     The nutritional status of CP children may be decreased when children have chewing disorders~     too due to insufficient solid food intake. The objective of this study was to investigate~     growth, dietary intakes and feeding behaviours of children with CP who have chewing~     disorders, and to compare them with their healthy peers.~   "
59705|NCT02785380|"~     Management of recurrent HCC is urgent and several treatments have been developed .Repeat~     hepatectomy is considered to be the first choice for recurrent HCC.~      Unfortunately, repeated open hepatectomy can be performed only in a small proportion of~     patients due to inadequate liver function reserve, widespread recurrence or high~     invasiveness. Given that recurrent tumors are usually detected at small size during follow-up~     after initial surgery, radiofreqency ablation (RFA), which is less invasive, may be locally~     curative and causes minimal damage to liver function reserve,has been widely used. However,~     the re-recurrence rate after RFA is more than 50%,and the recurrence-free survival is less~     than 20%. Recently, satisfactory short- and long-term oncological outcomes have been reported~     for laparoscopic surgery (LS) for the treatment for primary HCC with cirrhosis. Some single~     center pilot studies reported that LS may, compared with open surgery, improve the prognosis~     of HCC with less blood loss and shorter hospital stay. LS was initially considered not~     suitable for recurrent HCC due to postoperative adhesions that might make laparoscopic~     surgical procedure more difficult and less safe. With improvement in technique and~     experience, recent studies showed that LS for recurrent HCC in cirrhotic patients is a safe~     and feasible procedure with good short-term outcomes. However, thus far, no study has been~     performed to evaluate the long-term oncological outcomes of LS for recurrent HCC, and compare~     those results to that for RFA. To clarify these issues, a multicenter retrospective~     comparative study by using propensity score matching method that included a large consecutive~     series of patients with recurrent HCC within Milan criteria, who underwent LS or RFA, was~     performed.~   "
59706|NCT02785367|"~     The pH levels of a neonatal at his birth are an important factor in establishing the~     connection between events that occurred during the actual time of birth, to the risk of a~     significant morbidity development in the future. Gas values in cord blood are measurable and~     represent the condition of the fetus close to the time of birth. Their level is one of the~     essential criteria which are used to define acute hypoxic event during birth. As the oxygen~     supply to the fetus significantly disturbed, deficiency of oxygen in the tissues is growing.~     Therefore, the tissues begin to accumulate large amounts of acid and thereby developing fetal~     blood acidosis. Many works connected the presence of cord blood acidosis to development of~     neonatal cerebral palsy. According to the American Association of Obstetrics and Gynecology,~     cord blood gas sample is necessary when a prenatal event may be related (rightly or not) with~     negative neonatal outcome. This approach might be necessary when the case is legally~     controversial and there is a need to prove that umbilical cord gas values were normal at the~     prenatal period.~   "
59707|NCT02785354|"~     The study is an analysis using the French national health insurance database, six months~     after the beginning of NOAC launch in the NVAF indication.~      The aim is to compare the one-year, two-year and three-year benefit-risk (major bleeding,~     arterial thrombotic events, myocardial infarction (MI), death) between patients starting a~     NOAC and patients starting a VKA for NVAF in 2013~   "
59708|NCT02785341|"~     Although treatments significantly increase the life expectancy of cancer patients, their~     quality of life is more or less reduced. The development of supportive care, such as physical~     activity, is one of the tools that should be promoted to maintain quality of life and reduce~     treatment side effects, including fatigue.~      This study was developed to understand the different biopsychosocial effects of a physical~     activity program carried out with patients suffering from various types of cancers, and to~     facilitate and improve the implementation of this type of activity in health care facilities.~      Study randomized, controlled, cross-over intervention evaluating a 12-week supervised and~     adapted physical activity program.~      Participants were assigned to one of two groups: Group A which first follows a 12-week~     physical activity program, then undergoes usual care for 12 additional weeks, or Group B,~     which continues usual care for 12 weeks (control group) and then starts the physical activity~     program for 12 additional weeks. Quality of life (with questionnaires for 2 groups) ,~     well-being, fatigue, physical capacity, leptin concentration, goal setting and level of~     physical activity are evaluated during this protocol.~      By understanding the multidimensional effects of a physical activity program for various~     cancer types, depending on the time of proposing the program, by evaluating the correlations~     among all these variables, and by evaluating long-term effects, the IPCAPA study contributes~     to identifying the physical activity program which will be effective, viable and feasible for~     all patients undergoing chemotherapy, whatever the type of cancer.~   "
59709|NCT02785328|"~     Sleep exerts a dual effect on learning: on the one hand, good sleep quality allows good~     daytime aptitudes leading to knowledge acquisition. On the other hand, sleep after learning~     is necessary for knowledge consolidation. A key role of sleep has clearly been demonstrated~     in memory consolidation in adults. Sleep leads to strengthen memory by promoting brain~     plasticity. Surprisingly, sleep influence on learning stabilization has scarcely been studied~     during childhood and in children affected by sleep disorders. Yet, sleep disorders concern~     almost 30% of children and are frequently related to a worsening in academic performances.~     Classical neuropsychological evaluations of these children, based on daytime learning, often~     fail to determine cognitive profiles explaining their academic difficulties. The~     investigators hypothesize that a lack of sleep-dependent consolidation could take an active~     part in these children's cognitive and academic difficulties. This proposal aims at~     characterizing interactions between sleep, learning and memory processes that have not been~     studied in children of elementary school age (6-12 years). The investigators will evaluate~     sleep-dependent memory consolidation processes in children with sleep disorders before and~     after treatment and healthy controls. Neuropsychological testing and academic performances~     will be also evaluated.. The comparison of performances obtained before and after medical~     treatment, will allow to understand whether normalisation of sleep quality permits the~     restoration of sleep-dependent memory consolidation.~   "
59711|NCT02785302|"~     This is a multi-site, longitudinal study and it describes the transition process of~     behaviorally-infected HIV-positive youth as they move from pediatric- and adolescent-specific~     care to adult care. To achieve this goal, the transition process is characterized from the~     perspectives of HIV-positive youth, Adolescent Medicine Trials Unit (AMTU) clinic staff, and~     receiving adult clinic staff.~   "
59712|NCT02785289|"~     The purpose of this study is to compare the performance of cotton and flocked swabs for~     vaginal self-sampling.~   "
59713|NCT02785276|"~     Aim~      The general aim of this study is to improve post-operative pain and reduce morphine~     consumption following laparoscopic ventral hernia repair (LVHR). We specifically aim to~     conduct a randomized, double blinded, controlled trial to investigate the effect of~     intra-peritoneal local anaesthesia infusions on post-operative morphine consumption and.~      Methods:~      Patients will be randomised by computer generated random numbers (random permutation) and~     opaque envelope methods. At closure, one small 2mm catheter belonging to the AutoFuser pain~     pump system will be placed in the peritoneal cavity between the onlay mesh and parietal~     peritoneum. In the treatment arm patients will receive 275mL of 0.2% ropivacaine at 4mL/h. In~     the placebo arm, 275mL of 0.9% normal saline will be used in a similar fashion. The infusions~     will run for 68 hours total. All members involved in patient care (with the exception of one~     independant research fellow) will be blinded to the above. After 68 hours the pump will be~     stopped and the catheter will be removed. Assessment of post-operative pain will be performed~     by visual analogue scale, and total opiate consumption will be collected and converted into~     morphine equivalents.~      Health significance:~      Local anaesthesia has become an important addition to multimodal regimens of analgesia~     following surgery. Recent studies have shown that local anaesthetic (LA) wound infiltration~     has improved post-operative pain when compared with standard opioid regimens for pain relief.~     Only one previous study looked at bupivacaine infusions into the hernia sac for three days~     following LVHR. This study found no improvement in post-operative pain or morphine~     consumption. We aim to demonstrate improved pain and reduced morphine consumption using an~     alternative catheter insertion technique and ropivacaine as the desired LA agent.~   "
59714|NCT02785263|"~     The purpose of this study is to maximize patient involvement in the treatment of anal cancer.~     Specifically, the investigators will investigate whether patients wish to take part in the~     decision making on radiation dose and whether they want a high or low radiation dose.~   "
59715|NCT02785250|"~     Immunotherapeutic survivin vaccine DPX-Survivac, low dose oral cyclophosphamide, and IDO1~     inhibitor epacadostat will be tested together for the first time in patients with recurrent~     ovarian, fallopian tube, or peritoneal cancer to determine the safety and potential~     immune-modulating activity of the combination of these agents.~   "
59716|NCT02785237|"~     The objective of the study is to evaluate the process of early re-endothelialization of the~     Coroflex® ISAR Drug-eluting stent compared with the Ultimaster® Drug-eluting stent~   "
59717|NCT02785224|"~     Early stress-dose steroids are of uncertain efficacy in cardiac arrest. The current authors~     plan to conduct a pertinent mediation analysis using prospectively collected data from 2~     prior randomized clinical trials of in-hospital cardiac arrest. These trials reported~     positive results on the vasopressin-steroids-epinephrine (VSE) combination. The current~     analysis is aimed at identifying mediators of the benefit associated with VSE, potentially~     attributable to its stress-dose steroid subcomponent. Tested mediators will include arterial~     pressure in the early postresuscitation period (primary), and arterial blood lactate in the~     early postresuscitation period and renal failure free days (secondary).~   "
59718|NCT02785211|"~     Background: It is essential to understand how to prevent and treat the epidemic of~     depression. Several studies have reported the prevalence of depressive symptoms in the urban~     population in China, but there is a lack of information regarding intervention for depression~     in rural left behind old elderly people.~      Objective: To evaluate the effectiveness of a Modified Behavioral Activation Treatment (MBAT)~     Intervention on reducing depressive symptoms in rural left behind elderly people.~      Methods: 80 rural left behind elderly people who had a Geriatric Depression Scale(GDS) score~     between 11 and 25 will be recruited and randomly assigned to the intervention (n=40) and~     control group(n=40). The intervention group will be received both MBAT and treatment-as-usual~     for 8 weeks while the control group received treatment-as-usual. Both groups will be assessed~     with the GDS, Beck Anxiety Inventory (BAI), and Oxford Happiness Questionnaire (OHQ) at~     baseline, immediately post-intervention, and at 3 months post-intervention.~      Significance: This is the first time BA psychotherapy will be used in China.The current study~     will develop an intention model based on the traditional BA and CBT. The recurrence and~     seriousness of depression symptoms may be reduced by the intervention program. We hope that~     MBAT in clients will provide a direction for the management of mental health in rural~     left-behind elders..~   "
59719|NCT02785198|"~     Overall project design: This PhD project involves a randomized study on diabetic individuals~     with healing resistant wounds, comparing the effect of passive movement of the lower limb~     with standard treatment of diabetic wounds.~      How to effectively improve the condition of peripheral arterial disease is limited. The~     primary purpose of this study is to uncover whether passive movement of the lower limb will~     influence muscle oxygen demand and thereby increasing blood flow. An increase in muscle~     oxygen demand is likely to increase both blood flow rate and the number of capillaries, which~     would induce the healing of wounds, that were not previously possible.~      The secondary purpose is to increase understanding of the pathophysiological processes in~     wound healing through the study of biochemical markers of vascularization, inflammation and~     stem cell recruitment in blood samples. Further on analyzing the skin and muscle biopsies of~     the number and quality of endothelial cells and Capillary density and to develop new~     quantifiable methods to evaluate wound healing in.~      The project is a randomized trial, consisting of simple passive training to improve blood~     vessel function, increase the growth of the smallest blood vessels, thereby preventing~     ulceration and ultimately amputation.~   "
59720|NCT02785185|"~     A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study.~   "
59721|NCT02785172|"~     Safety and Efficacy of IDP-118 Lotion to Ultravate® Cream, in the Treatment of Plaque~     Psoriasis~   "
59722|NCT02785159|"~     Safety and Efficacy of IDP-118 Lotion in the Treatment of Plaque Psoriasis~   "
59723|NCT02785146|"~     A randomized, paralleled control clinical study investigating Huaier Granule for prevention~     of recurrence and metastasis of colorectal cancer after radical surgery, to evaluate the~     efficacy and safety.~   "
59724|NCT02785133|"~     This study uses a prospective non-randomized, non-controlled design. Five-hundred (500)~     subjects having previously received a peripheral intravenous therapy will be enrolled into a~     single treatment group. The purpose of the study is to evaluate the safety, feasibility, and~     improved energy levels following treatment with a low-light source integrated into an~     existing peripheral intravascular catheter. The absence of a control group is based on the~     following reason:This is a pilot investigation to establish a baseline understanding of the~     safety, feasibility, and cursory utility of polychromatic light emitting diodes integrated~     into an existing 20-gauge 1.0 inch intravenous catheter to improve self-reported overall~     subject energy levels.~   "
59725|NCT02785120|"~     This is a phase 2, multicenter, randomized, double-blind (within dose), placebo controlled,~     parallel-group, dose-range finding study to evaluate the efficacy and safety of TF0023 spray~     versus placebo in functional improvement of patients with ischemic strokes under standard of~     care.~   "
59726|NCT02785107|"~     The promotion of physical activity (PA) is paramount to public health, yet interventions in~     the social cognitive tradition have yielded negligible improvements. Two reasons for these~     results may be the over reliance on intention as the proximal determinant of behaviour and a~     lack of consideration of implicit/automatic determinants of PA. The purpose of this study was~     to apply Multi-Process Action Control (M-PAC), a framework centered on PA~     intention-translation and the gradual building of habit to examine PA change using a two-arm~     parallel design, randomized controlled trial.~   "
59727|NCT02785094|"~     This study focus on measuring effect of Egyptian Primigravidas' education level and~     accessibility to social media on rate of maternal request option offered for non-indicated~     primary caesarean section.~   "
59728|NCT02785081|"~     The purpose of this study is to evaluate the thoracic skin to epidural space depth in~     children and define the ratio between the straight and inclined thoracic skin to epidural~     depth.~   "
59729|NCT02785068|"~     A phase 1b/2a study evaluating the combination of MM-151 + nal-IRI + 5-FU + Leucovorin in~     RAS/RAF wild-type Metastatic Colorectal Cancer.~   "
59730|NCT02785055|"~     This blinded, randomized study compares standard palpation to ultrasound-assisted landmark~     identification of the thoracic spine for thoracic epidural catheterization.~   "
59731|NCT02785042|"~     This prospective, single-arm clinical multicenter study intends to measure normal structural~     parameters of the optic nerve head, the peripapillary retinal nerve fiber layer, and the~     macula using the Heidelberg Spectralis OCT device. This study is conducted in Hispanic~     descent volunteers. The main goal of the study is to provide the range of these structural~     parameters in normal eyes. The study will include at least 240 normal volunteers.~   "
59732|NCT02785029|"~     This prospective, single-arm clinical multicenter study intends to measure normal structural~     parameters of the optic nerve head, the peripapillary retinal nerve fiber layer, and the~     macula using the Heidelberg Spectralis OCT device. This study is conducted in~     African-American descent volunteers. The main goal of the study is to provide the range of~     these structural parameters in normal eyes.~   "
59733|NCT02785016|"~     This is a prospective, non-randomized, observational, single center study in which subjects~     that have surgically-correctable Stress Urinary Incontinence undergo a suburethral sling~     operative procedure.~   "
59734|NCT02785003|"~     This study will evaluate the effectiveness of ketamine infusions in the management of acute~     pain following open or laparoscopic colorectal surgery cases. Half of patients will receive~     the institutional standard of care and a placebo infusion (no active medication). The other~     half of patients will receive the institutional standard of care and a ketamine infusion. All~     subjects and staff will be blinded as to whether they are receiving placebo or ketamine.~   "
59735|NCT02784990|"~     Surgery is the principal treatment for benign and malignant pancreatic tumours. This surgery~     can be accompanied by complications among which the main one is pancreatic fistula, which~     leads to the flow of pancreatic juices into the abdominal cavity. Depending on its severity,~     a fistula can be managed medically, with the implantation of a la pose d'un percutaneous~     drain, endoscopic treatment, or revisit surgery. It has been shown that early management of~     the fistula prevents it from evolving towards major complications such as haemorrhage or~     serious intra-abdominal infections.~      To date, the early diagnosis of pancreatic fistula is based on high levels of one pancreatic~     enzyme, amylase, in the drains. However in certain clinical situations, patients present~     post-operative fistulas with no elevation of amylase. And, on the contrary, increased amylase~     with no clinical consequences.~      It is therefore necessary to identify another early early marker of pancreatic fistula that~     corresponds better to clinical signs.~      In a preliminary study conducted in 65 patients, the investigators recently found that~     another pancreatic enzyme (lipase) could be a more pertinent marker of pancreatic fistula,~     but this requires confirmation in a greater number of patients.~      The objective is to evaluate the diagnostic performance of lipase in the drains for the early~     detection of pancreatic fistula with clinical repercussions in the 30 days following the~     surgery.~      The study consists in collecting at 4 different time points (D1, D3, D4 and D6) a tube of~     blood and a tube of drain liquid.~   "
59736|NCT02784977|"~     Primary aim of the TURKAPNE (The Turkish Sleep Apnea Database) study is to generate a~     cross-sectional nationwide database to define clinical and polysomnographic characteristics~     of the sleep apnea patients in Turkey. Associations of phenotypes of sleep apnea patients~     with metabolic and cardiovascular diseases as well as risk for traffic accidents will be~     explored as secondary aims. Impact of treatment of sleep apnea on metabolic and~     cardiovascular complications as well as compliance with positive airway pressure treatment~     will be further explored longitudinally.~   "
59737|NCT02784964|"~     1. To assess the safety of allogeneic injection of expanded ADSCs to patients with knee~          osteoarthritis~        2. To assess the efficacy of allogeneic injection of expanded ADSCs to patients with knee~          osteoarthritis~   "
59738|NCT02784951|"~     The main objective of this study is to evaluate the use of RBC, FDP, WB in the treatment of~     exsanguinating patients by physician-staffed emergency medical services in Norway, with focus~     on prehospital transfusion complications and safety.~   "
59739|NCT02784938|"~     The purpose of this project is to evaluate a promising peer-run psycho-educational group~     intervention titled Vocational Empowerment Photovoice (VEP) that aims to empower~     individuals with the most disabling psychiatric disabilities to engage in vocational services~     and pursue employment through the enhancement of their vocational hope, sense of vocational~     identity, work motivation, work-related self-efficacy, and capacity to deal with psychiatric~     stigma and discrimination.~   "
59740|NCT02784925|"~     Ultrasound (US) B mode image is an alternative method to measure tissue structure and has~     proven to be an accurate technique to measure subcutaneous fat thickness. However, pressing~     the transducer onto the skin with too much force will significantly reduce the subcutaneous~     adipose tissue thickness. In this study, a force controlled system combined with US~     transducer was used for 3D subcutaneous fat imaging and reconstruction.~   "
60034|NCT02781038|"~     Patients who smoke and suffer from fractures are worse off than those who do not smoke.~     Orthopaedic patients represent a group that can benefit from physician contributions to~     smoking cessation, and a special opportunity to cue this can begin with the orthopaedic~     surgeon in the acute setting. However, the best way to appropriately counsel these patients~     and assess the impact as a teachable moment remains undetermined.~   "
59741|NCT02784912|"~     Prevalence of HF reaches 1-2% of developed populations, and consequently a significant~     problem becomes more frequent occurrence of ventricular arrhythmias (VA) - sustained~     ventricular tachycardia (sVT) and electrical storm (ES) requiring radiofrequency ablation.~      The aim of the study is to create a model of risk stratification to identify patients with~     increased risk of occurrence of composite (cardiovascular death or rehospitalization,~     arrhythmia recurrence) and secondary (inadequate device therapy, all-cause death or~     rehospitalization, intensification of atrial arrhythmia) endpoints after ablation of ES or~     sustained VT. Model will be based on additional measurements of N-terminal pro brain~     natriuretic peptide (NT-proBNP), Galectin-3, suppressor of tumorigenicity 2 (ST2), high~     sensitive troponin T (hs-TnT), high sensitive C-reactive protein (hs-CRP), iron deficiency to~     clinical-, electrocardiographic- and echocardiographic assessment.~   "
59742|NCT02784899|"~     One lung ventilation (OLV) is essential during thoracic surgery. During OLV, intrapulmonary~     shunt can be increased resulting hypoxemia. Although OLV technique had been advanced so far,~     hypoxemia during OLV reaches about 10% in spite of inspired oxygen fraction 100%. Iloprost is~     a prostaglandin analogue used for pulmonary hypertension, which can decrease pulmonary artery~     resistance by selectively dilating pulmonary artery. In this prospective, randomized, double~     blind study, investigators are planning to investigate the effects of iloprost on respiratory~     physiology (intrapulmonary shunt, deadspace, oxygenation, etc).~   "
59743|NCT02784886|"~     The purpose of this study is to determine whether, in a high risk population (placenta~     praevia and previous caesarean or prenatal suspicion of morbidly adherent placenta (MAP)),~     the concentration of cell-free fetal DNA circulating in the maternal plasma is significantly~     increased in the subgroup of morbidly adherent placenta (MAP) cases , in order to determine~     if the dosage of cell-free fetal DNA circulating in the maternal plasma may be a useful~     biological tool to detect MAP, alone or in addition to the imagery findings (ultrasonography~     and RMI).~   "
59744|NCT02784873|"~     The purpose of the trial is to compare the effects of high intensity interval training (HIIT)~     with usual care - moderate intensity steady state training (MISS) - in UK cardiac~     rehabilitation (CR) programmes.~   "
59745|NCT02784860|"~     This study assesses the benefits of continuous intravenous lidocaine administration during~     sedation for colonoscopy.~      Sedation will consist of propofol infusion titrated to provide adequate working conditions to~     the gastroenterologist. Patients will be randomly allocated into two groups: lidocaine~     infusion (bolus of 1.5 mg/kg followed by a continuous infusion of 4 mg/kg/h) or the same~     volume of placebo (normal saline)~   "
59746|NCT02784847|"~     A pilot trial of triheptanoin, a natural compound able to promote anaplerotic mitochondrial~     metabolism, for the preventative treatment of migraine.~   "
59747|NCT02784834|"~     The purpose of the study is to investigate the safety of the investigational drug called~     dimethylfumarate (DMF). DMF is a type of drug called an immunomodulatory drug. This drug is~     approved by the United States (U.S.) Food and Drug Administration (FDA) as a treatment for~     patient with multiple sclerosis.~      Although there is evidence from tests on laboratory animals that DMF can decrease the number~     of CLL cells, we do not know if this will work in humans with CLL. This drug will be given to~     humans with CLL for the first time in this study. Therefore, the goal of this study is to see~     if DMF is safe and tolerable in study participants. Participants will be evaluated to find~     out what effects (good and bad) DMF has on the body and see how long the drug stays in the~     body.~   "
59748|NCT02784821|"~     Prolonged antibiotic use in preterm neonates has significant consequences on the developing~     intestinal microbiome, metabolome and host response, predisposing the neonate to various~     major morbidities, including necrotizing enterocolitis (NEC), late-onset sepsis,~     bronchopulmonary dysplasia (BPD), and mortality.~      The hypothesis is that early and prolonged antibiotic use in preterm neonates has significant~     consequences on the developing intestinal microbiome, metabolome and host response,~     predisposing the neonate to various major morbidities. It is possible that the effect of this~     widespread antibiotic use outweighs the potential benefits. This study will randomize preterm~     infants born at less than 33 weeks gestation to either pre-emptive antibiotics or~     no-pre-emptive antibiotics.~      The purpose of this research is to evaluate the risks and benefits of current practice to~     determine optimal levels of antibiotic use that protects the babies from infection with~     minimal effect on the microbiome and subsequent adverse outcomes related to overuse of~     antibiotics.~   "
59749|NCT02784808|"~     This study is designed to analyze the frequency and incidence rate of pulmonary complications~     in JIA participants who received biological DMARDs and non-biologic DMARDs. The participants~     having evidence of of a prescription or administration of one of the biologic or non-biologic~     DMARDs will be included in five different treatment groups. Data from the Thomson Reuters~     MarketScan® Commercial Claims and Medicare Supplemental Databases will be used to estimate~     the incidence rate of pulmonary complications.~   "
59750|NCT02784795|"~     The main purpose of this study is to evaluate the safety of the study drug known as LY3039478~     in combination with other anticancer agents in participants with advanced or metastatic solid~     tumors.~   "
59751|NCT02784782|"~     Rationale: Thoracolumbar burst fractures are frequently seen in the trauma population, they~     have a large impact on patient's wellbeing and are a large economic burden to society.~     Thoracolumbar burst fractures might not need the standard care of brace immobilization for~     adequate treatment and a functional treatment might lead to same or better functional~     outcomes. Besides that, with functional outcome length of hospital stay might decrease and it~     might also be cost effective compared to bracing.~      Objective: The investigators aim to study the use of braces for thoracolumbar burstfractures,~     not only by measuring the functional scores and the effect of the bracing or functional~     treatment on the increase in kyphosis angle, but also on (health related) quality of life and~     health economics. The investigators hypothesize that no treatment is superior over one other.~      Study design: This project is a randomised controlled trial comparing brace and no brace~     treatment on function, kyphosis angle, pain, quality of life, and costs.~      Study population: Patients between 18 and 65, with a single level thoracolumbar burst~     fracture will be included. The fracture has to have a kyphosis angle of less than 35 degrees~     and patient has to be neurologically intact. Patients are excluded when they are overweight~     (BMI> 35), need multidisciplinary treatment due to multitrauma, or have inadequate knowledge~     of the Dutch language. Patients included in the brace group will automatically take part in a~     brace compliance study.~      Intervention: One group receives a Thoracolumbar Sacral Orthesis (TLSO) for 6 weeks, the~     other group receives no TLSO Main study parameters/endpoints: The primary outcome of this~     study is the functional score at six months after trauma. Secondary outcomes are pain,~     kyphosis angle, health related quality of life, healthcare costs and brace compliance.~      Literature shows no difference in pain, functional outcome or kyphosis angle, therefore no~     potential risks are known comparing a brace and a functional treatment. Investigators aim~     that not using the TLSO results in similar functional outcome, pain and kyphosis angle, and~     less costs. Patients will be seen at first presentation and during two year follow up at the~     outpatient clinic at six standard care follow up moments. At these follow up moments a X-ray~     as part of standard care is made. At or just before each scheduled appointment they will fill~     in questionnaires taking from 15-45 minutes.~   "
59752|NCT02784769|"~     During their biological life, proteins undergo molecular aging due to many non-enzymatic~     post-translational modifications that alter their structural and functional properties. These~     reactions concern all proteins but especially tissue proteins (whose half-life in the~     organism can be several decades) and lead to the formation of complex products called PTMDPs~     (post-translational modification derived products). Molecular aging is responsible for the~     alteration of protein properties which may cause changes in mechanical properties of tissues~     during aging and pathologies. However, the involvement of these processes in vivo remains~     unclear, particularly in the aneurysmal pathology. So, the aim of this study is to determine~     whether the molecular aging of matrix proteins within the vessel wall may participate in the~     development of aortic aneurysm.~   "
59753|NCT02784756|"~     The study will prospectively determine the clinical utility of CMV cell-mediated immunity~     using the Quantiferon test. The investigators will use the assay results to tailor the~     duration of CMV prophylaxis in solid organ transplant patients.~   "
59754|NCT02784743|"~     Lymphatic filariasis is a public health problem in Mali. The existing data are not up to date~     and most of them are more than 15 years old. To address this issue in April 2000, the~     investigators started studies to update the epidemiology of lymphatic filariasis. There is no~     ongoing lymphatic filariasis control program in 2000 in Mali in terms of preventive~     chemotherapy treatment or vector control.~      To fill these gaps, this current study aims to assess the impact of albendazole-ivermectin~     combination treatment on Wuchereria bancrofti infection and transmission in 6 rural highly~     endemic villages of Mali.~   "
59755|NCT02784730|"~     Peripherally Inserted Central Catheter (PICC) and port-a-cath (PAC) are the most commonly~     medical devices used for the administration of chemotherapy.~      Placement of these devices via central venous access is sometimes responsible for~     complications.~      The incidence of these complications is correlated with the device holding time.~      A strategy of iterative PICC placement could significantly reduce these complications.~   "
59756|NCT02784717|"~     This non-interventional field study will investigate rivaroxaban under clinical practice~     conditions for stroke prevention and for prevention of non-CNS systemic embolism in patients~     with non-valvular atrial fibrillation in China.~   "
59757|NCT02784704|"~     This is a Phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to~     assess the efficacy, safety, and pharmacokinetics (PK) of eravacycline compared with~     meropenem in the treatment of complicated intra-abdominal infections (cIAIs).~   "
59758|NCT02784691|"~     The aim of the study is to evaluate the antalgic efficacity of Feeligreen® patch on~     osteoarthritic knee pain acute. This patch work by diffusion controlled by iontophoresis~     allowing an improvement of transdermal diffusion of active (Diclofenac).~   "
59759|NCT02784678|"~     The purpose of this study is to confirm that minimally invasive closed reduction and internal~     fixation with fully threaded headless cannulated compression screws for distal radius~     fracture repair has advantages over conventional open reduction internal fixation with~     titanium plates, providing superior fragment stability and allowing for early rehabilitation~     exercise of the wrist joint, which improves recovery of function. Also to show that minimally~     invasive closed reduction and internal fixation with fully threaded headless cannulated~     compression screws is the more suitable surgical method for repair of distal radius fracture.~   "
59760|NCT02784665|"~     Central serous chorioretinopathy (CSC) is a relatively frequent eye disease in younger~     patients. It is characterized by serous detachment of the neurosensory retina with or without~     serous detachment of the retinal pigment epithelium (RPE), which can cause vision drop, image~     distortion, loss of color and contrast vision. Although nonfoveal focal leakage can be~     treated with traditional laser photocoagulation, but it has the side effects of causing RPE~     atrophy, scotoma, or secondary CNV. Photodynamic therapy (PDT) is another effective treatment~     but it's more than most families can afford to pay because of the high cost, what's more, it~     is accompanied with side-effects, such as choroidal ischemia, retinal pigmental epithelium~     (RPE) atrophy and RPE rip.~      To date there is no international consensus on the optimal treatment of CSC Many~     retrospective studies suggest that micropulse laser (MPL) therapy may also be effective~     without obvious complications in this disease.~      The purpose of this study is to evaluate the effect of micropulse laser (MPL) on acute~     central serous chorioretinopathy compared with the traditional laser coagulation.~   "
59761|NCT02784652|"~     Bone metastasis causes bone destruction and skeletal related events (SRE) including~     compression fracture, hypercalcemia, and spinal cord compression. Therefore, palliative~     treatments for pain control and local control have become important and multidisciplinary~     multimodality approach is needed for treatment of bone metastasis.~      The efficacy of radiotherapy (RT) for bone metastasis is well known. And the results that~     bisphosphonate decreases SRE in patients with solid tumor and multiple myeloma reported. In~     previous retrospective reports, the combination of local RT and systemic bisphosphonate was~     more effective than RT alone.~      Therefore, Investigators designed a phase II study to evaluate the efficacy of RT in~     combination with zoledronic acid on pain relief and the safety of RT in bone metastasis~     patients with gastrointestinal tumors.~   "
59762|NCT02784639|"~     The goal of this multicenter prospective study is to validate, and ultimately translate in~     routine clinical practice, the use of plasma analysis of ccfDNA for the determination of KRAS~     mutation status in mCRC patients.~   "
59763|NCT02784626|"~     In this study, based on the hypothesis that dexmedetomidine administered intraoperatively for~     sedation can reduce postoperative pain than that of propofol, the investigators examined the~     ability of dexmedetomidine to reduce postoperative pain in in patients undergoing the total~     knee arthroplasty.~   "
59778|NCT02784418|"~     Design: Single center, double-blind, sham-controlled trial that will randomize symptomatic~     patients with a coronary chronic total occlusion (CTO) to CTO percutaneous coronary~     intervention (PCI) or a sham procedure. All patients will receive optimal medical therapy.~      Treatment:CTO PCI, as per standard clinical practice.~      Control: Patients randomized to sham-procedure will undergo only bilateral arterial access,~     without angiography or PCI being performed.~      Secondary Endpoints: (1) Greater improvement in SAQ-7 Summary scores during the entire~     duration of follow-up (6 months) using a repeated measures analysis (2) Greater improvement~     in individual components of patients' health status (3) Greater improvement in exercise~     capacity (4) Similar incidence of major adverse cardiac events (MACE), both peri-procedural~     and long-term~   "
59764|NCT02784613|"~     This is an unblinded study to be conducted at a single research center, San Diego Sexual~     Medicine. Subjects meeting inclusion and exclusion criteria will receive 60 mg ospemifene~     daily for twenty weeks. After the informed consent is signed, a baseline physical~     examination, and vulvoscopy with detailed photography of the vulva, vestibule and vagina,~     will be performed. Physical examination and vulvoscopy with detailed photography of the~     vulva, vestibule and vagina, will be repeated prospectively every 4 weeks for a total of 20~     weeks. Therefore, physical examination and vulvoscopy with detailed photography of the vulva,~     vestibule and vagina will be performed prospectively at baseline (vulvoscopy session 1), 4~     weeks (vulvoscopy session 2), 8 weeks (vulvoscopy session 3), 12, weeks (vulvoscopy session~     4), 16 weeks (vulvoscopy session 5) and 20 weeks (vulvoscopy session 6) following daily~     administration of 60 mg ospemifene.~   "
59765|NCT02784600|"~     The purpose of this clinical registry is to prospectively collect and compare preoperative~     and postoperative patient-reported data using validated shoulder-specific and health-related~     quality of life (QoL) instruments during real-world use of the Rotation Medical bioinductive~     implant to treat rotator cuff tears.~   "
59766|NCT02784587|"~     Based upon Northern New England Cardiovascular Study Group data, the rate of post operative~     atrial fibrillation (POAF) requiring treatment following coronary artery bypass grafting~     (CABG) at Maine Medical Center (MMC) is currently 30%. Nationally, POAF occurs in up to 40%~     of patients post CABG, 50% of patients after valve surgery, 64% of patients post mitral valve~     and CABG and 49% after aortic valve replacement. Atrial fibrillation worsens a patient's~     hemodynamic status and increases the risk of congestive heart failure (CHF), embolic events~     and longer ICU stays leading to increased patient morbidity and strain on financial~     resources. In the U.S., POAF carries a higher risk of stroke (37% OR 2.0 in-hospital~     mortality (OR = 1.7), worsened survival (74% versus 87%), and an additional 4.9 days and~     $10,000-$11,500 in hospital stay costs.~      Atrial fibrillation requires both an initiation trigger and favorable environment for~     maintenance and the sympathetic and parasympathetic nervous systems play important roles in~     this regard. Unfortunately, the precise mechanisms of POAF are still being investigated. This~     postoperative complication has persisted in spite of efforts to mitigate it pharmacologically~     with beta blockers and amiodarone, an experience shared by most other cardiac surgery~     centers.~      The stellate ganglion is formed by the fusion of the inferior cervical sympathetic ganglion~     and first thoracic sympathetic ganglion. By modulating the sympathetic component of the~     autonomic nervous system, stellate ganglion stimulation has been shown to facilitate~     induction of atrial fibrillation while ablation may reduce or prevent episodes. Human studies~     have further supported this model.~      Preliminary studies of perioperative stellate ganglion block (SGB) in cardiac surgery suggest~     that this technique may reduce or prevent episodes of POAF requiring treatment. The~     investigator's ultimate goal is to determine whether SGB reduces the incidence of POAF in~     specific cardiac surgery populations at MMC. First, however, the investigator proposes to~     test the hypothesis that SGB, performed perioperatively by cardiac anesthesiologists in a~     population of patients undergoing cardiac surgery, is both safe and clinically feasible.~   "
59767|NCT02784574|"~     This study aims to investigate current aftercare activities in Denmark after intensive care~     unit (ICU) treatment. The hypothesis is that a large number of hospitals offer aftercare, and~     these interventions are heterogenic and differ between hospitals and regions.~      This study is an electronic questionnaire survey that aim to describe and map Danish~     aftercare activities, and future development plans in this field.~   "
59768|NCT02784561|"~     The purpose of this study is to determine the safety and efficacy of Busulfan/FLAG~     (fludarabine, cytarabine and granulocyte colony-stimulating factor) Conditioning Regimen in~     Patients with Relapsed/refractory Acute Leukemia undergoing allogeneic peripheral blood stem~     cell transplantation.~   "
59769|NCT02784548|"~     This study will develop a virtual reality-based treatment for phantom limb pain among~     Veterans and test it against the most established behavioral therapy for phantom limb pain,~     mirror therapy.~   "
59770|NCT02784535|"~     Drug therapy for patients suffering from autonomic failure and neurogenic orthostatic~     hypotension are scarce and not effective. If left untreated, these patients have the highest~     risk of syncope, falls and fall-related injuries. The proposed study will determine the~     clinical benefit of a commercially available drug, atomoxetine, to reduce symptoms associated~     with neurogenic orthostatic hypotension in patients with autonomic failure.~   "
59771|NCT02784522|"~     This study protocol represents an attempt to objectively choose appropriate methods for~     internal fixation of proximal humerus fractures in older patients by comparing locking~     compression plate with conventional steel plate fixation to improve shoulder function.~   "
59772|NCT02784509|"~     The purpose of this study is to determine the effect of severe obesity on physical activity,~     sedentary behavior and cardiometabolic risk factors during childhood and adolescence and~     whether these associations are modified by race. Additionally, the study will investigate the~     contributions of (total, regional, and depot-specific) fat accumulation on changes in~     physical activity, sedentary behavior, and cardiometabolic risk factors during childhood and~     adolescence.~   "
59773|NCT02784496|"~     The goal of this clinical research study is to collect data about the long term safety and~     tolerability of ruxolitinib when given to patients with MF.~   "
59774|NCT02784483|"~     The purpose of this pilot study is to gain initial insights into the biologic and clinical~     effects of Atezolizumab in patients with Asymptomatic Multiple Myeloma (AMM). The data may~     provide novel insights into anti-PDL-1-induced immunologic changes, which could potentially~     be relevant to its future development in Multiple Myeloma (MM) and other indications.~   "
59775|NCT02784470|"~     Selection of the optimal treatment for gastric outlet obstruction in patients with radically~     unresectable gastric cancer remains controversial because previous studies comparing the two~     procedures had a small sample size as well as they included various etiologies such as~     gastrointestinal (GI) cancer, duodenal cancer and pancreaticobiliary cancer in selecting the~     patient population. Therefore, to establish the standard of care for patients with radically~     unresectable gastric cancer with gastric outlet obstruction, a larger prospective,~     randomized, controlled clinical trial using a single type of stent is warranted.~   "
59776|NCT02784457|"~     Efficacy of the use of GnRH antagonist in treatment of those who develop early-onset severe~     ovarian hyperstimulation syndrome and had cancelled embryo transfer~   "
59777|NCT02784444|"~     This is a randomized, double-blinded study of three doses of MSDC-0602K or placebo given~     orally once daily to subjects with biopsy proven NASH with fibrosis and no cirrhosis.~   "
59815|NCT02783924|"~     The effect of vitamin D supplementation on genetic, proteomic , and metabolomic profile in~     adipose tissue will be studied in 50 subjects.~   "
59816|NCT02783911|"~     Comparison of clinical and radiographic success between Mineral Trioxide Aggregate and Ferric~     Sulfate pulpotomies for primary molars. Recall appointments are completed 6 months, 9 months~     and 12 months.~   "
59779|NCT02784405|"~     Self-apposing, drug-eluting Stentys coronary stents represent a valuable tool for the~     treatment of coronary artery stenosis. Their ability to adapt to widely varying vessel~     calibers and to auto-expand after their release to self-appose to vessel walls is~     particularly useful in the presence of ectasic coronary arteries or significant vessel~     tapering. The investigators planned this study to assess the feasibility, the effectiveness~     and the safety of the implantation of self-apposing, drug-eluting Stentys stents for~     percutaneous coronary intervention.~      Consecutive patients undergoing percutaneous coronary intervention with implantation of a~     self-apposing Stentys stent were enrolled in this multi center registry. Inclusion criteria~     were age ≥ 18 years and ability to provide informed consent. No exclusion criteria were~     defined.~      Primary end-point of the study is the occurrence of MACE (death, myocardial infarction, stent~     thrombosis, unplanned hospitalization for unstable angina, target lesion revascularization).~     Secondary end-points include individual components of MACE, procedural complications~     (periprocedural MI, bleedings, access site complication, failure to cross stent struts with~     guidewire in the treatment of bifurcation, failure to delivery the stent, contrast-induced~     nephropathy), bleedings at follow up.~   "
59780|NCT02784392|"~     The purpose of this study is to evaluate the effect Ulimorelin in patients with enteral~     feeding intolerance.~   "
59781|NCT02784379|"~     Mastalgia is a common problem for women. The aim of this study is to investigate the role of~     neuromuscular pathologies of the thorax wall at mastalgia ethiopathogenesis.~   "
59782|NCT02784366|"~     The purpose of this study is to establish a prospective observational cohort of cancer~     immunotherapy patients with GI side effects in order to identify biomarkers that predict GI~     complications due to treatment.~   "
59783|NCT02784353|"~     Clinical Outcomes of Preoperative and Postoperative Rehabilitation in the Patients With HBP~     Malignancy.~   "
59784|NCT02784340|"~     A Prospective, randomized study conducted on 120 pregnant women attending the labour wards in~     Kasr Al Ainy and Fayoum maternity hospitals from May 2014 to December 2015. All participants~     were scheduled for elective cesarean section under spinal anaesthesia and were randomly~     divided into 3 equal groups. Group 1(40 women) received 16 mg Dexamethasone IV drip. Group II~     (40 women) received 16 mg Dexamethasone subcutaneous injection around the caesarean section~     scar after skin closure and Group III received Placebo in the form of IV fluids 500 cc saline~     infusion. All cases were followed up for 48 hours for assessment of level of pain by using a~     10-cm visual analog scale (VAS). Primary outcome parameters were VAS score and the need for~     additional analgesics. Other parameters were hemodynamic changes and occurrence of side~     effects or complications~   "
59785|NCT02784327|"~     PRF110 is new extended release oily solution formulation of ropivacaine that is intended for~     local infiltration into surgical wounds. The purpose of this study is to determine the safety~     and early efficacy of PRF110 in bunionectomy surgery, to measure the pharmacokinetic profile~     of PRF110 over 72 hours and evaluate the duration of analgesia witnessed in the surgical~     setting.~   "
59786|NCT02784314|"~     In this observational cost efficacy study, the investigator compare the Laparoscopic Radical~     Prostatectomy (LRP) versus Robotic-Assisted Laparoscopic Prostatectomy (RALP). Every cost of~     care that include hospitalization related or post operative medical consumption are obtained~     and recorded up to 5 years follow up. Functional results (continence, potency, quality of~     life) are obtained through standardised questionnaires. Carcinologic results are estimated by~     Prostate Specific Antigen (PSA) relapse and salvage treatments. Economic evaluation will be~     made to estimate direct costs of the four postoperative year along with the incremental~     cost-effectiveness ratio (ICER) per successful surgical treatment (preserved urinary~     continence and erectile function and PSA < 0.2).~   "
59787|NCT02784301|"~     Belly breathing is a popular relaxation technique used to reduce anxiety and pain in children~     during medical procedures. The investigators have developed a biofeedback game that will help~     teach children how to belly breathe in an interactive way. Existing studies have shown that~     biofeedback tools are effective ways to teach relaxation techniques to children. The purpose~     of this study is to evaluate 1) whether this new biofeedback tool is a more a effective and~     engaging way to teach belly breathing to children and 2) whether the application is more~     effective in reducing procedural pain and anxiety compared to standard of care, self-directed~     belly breathing alone or self-directed belly-breathing combined with visual distraction. The~     investigators hypothesize that:~        1. The smartphone-based biofeedback game for belly breathing will reduce self-reported~          procedural anxiety and pain in children during a blood collection procedure compared to:~             1. standard of care~             2. belly breathing + standard care procedures~             3. belly breathing with visual components of the application with no coaching or~               biofeedback distraction.~        2. The smartphone-based biofeedback game will increase compliance with belly breathing~          compared to self-directed breathing.~        3. Belly breathing with smartphone-based biofeedback game will be more engaging compared to~          self-directed belly breathing.~   "
59788|NCT02784288|"~     Investigators will determine whether treatment stratification by neck dissection, to more~     accurately pathologically stage patients, minimizing the number of treatment modalities in~     patients with low risk oropharyngeal squamous cell carcinoma, can improve quality of life.~   "
59789|NCT02784275|"~     This is a double-blind, randomized, placebo-controlled, parallel-group comparison study to~     evaluate the efficacy and safety of Cyclo-Z for the treatment of subjects with obese type 2~     diabetes.~      The study will consist of 3 phases:~        -  Screening phase (2 weeks)~        -  Treatment phase (12 weeks)~        -  Follow-up phase (2 weeks)~      Following a 2-week screening period, subjects who meet all inclusion and exclusion criteria~     will be randomly assigned into one of the following treatment arms:~        -  Dose A: Cyclo-Z containing 23 mg zinc plus 3 mg CHP - 16 subjects~        -  Dose B: Cyclo-Z containing 23 mg zinc plus 9 mg CHP - 16 subjects~        -  Dose C: Cyclo-Z containing 23 mg zinc plus 15 mg CHP - 16 subjects~        -  Dose D: Placebo - 16 subjects~      The assigned dose will be orally administered to subjects once a day before bedtime for 12~     consecutive weeks. After the randomization at Week 0 (Visit 2), subjects will visit their~     respective trial sites at Weeks 2, 4, 6, 8, 10, 12, and 14 (Visits 3, 4, 5, 6, 7, 8, and 9).~   "
60035|NCT02781025|"~     The purpose of this study is to investigate the feasibility of using novel decellularized~     tissue matrices to isolate and culture circulating tumor cells (CTCs) collected from patients~     with metastatic solid tumor malignancies.~   "
59790|NCT02784262|"~     Chronic rhinosinusitis (CRS) with nasal polyps is a particularly challenging form of chronic~     rhinosinusitis in several ways. Patients have significantly more severe symptom burden and~     worse quality of life than patients with chronic rhinosinusitis without nasal polyps. Many~     patients return to the health care providers with persistent symptoms after repeated medical~     and surgical treatment. Patients have usually tried several different types of treatments,~     ranging from less invasive procedures to extensive surgical treatment. The surgical treatment~     is often repeated several times. The most common surgical treatment is functional endoscopic~     sinus surgery, another established procedure is Vidian neurectomy.~      The main object of this pilot study is to investigate the safety of onabotulinumtoxin A~     towards the sphenopalatine ganglion (SPG) in CRS patients with nasal polyps. Efficacy data~     will also be collected to provide indication on whether future placebo-controlled studies~     should be performed.~      Onabotulinumtoxin A inhibits the secretion of acetylcholine, blocking the parasympathetic~     reflex cascade in the SPG. As a result, the investigators expect less mucosal swelling,~     secretion and nasal polyps. The duration of such a blockade is believed to last for 3-9~     months and will not lead to damage of the nerve.~      This study opens up for improved treatment with less complications.~   "
59791|NCT02784249|"~     The purpose of this study is to compare the safety and efficacy of goniotomy performed with a~     novel ophthalmic knife compared to trabecular bypass stent implantation in mild to moderate~     glaucoma subjects who are also undergoing cataract extraction with phacoemulsification~     (Phaco) and posterior chamber intraocular lens (PCIOL) implant.~   "
59792|NCT02784236|"~     Prospective study of 6 months of evolution in people with type 1 diabetes with insulin~     multidose (MDI) and HbA1c> 7%. Patients were evaluated clinical, metabolic and psychological~     baseline and at 6 months, with a telematic visit at 3 months. We analyzed: glycemic control~     (HbA1c), glycemic variability (SD and MAGE), depressive symptoms (BDI-II), anxiety (STAI),~     treatment-related (DDS) distress, fear of hypoglycemia (FH-15), adhesion treatment (SCI-R),~     quality of life (DQOL) and treatment satisfaction (DTSQ) and the platform.~   "
59793|NCT02784223|"~     The purpose of the study is to investigate the contribution of PET-CT with F18-choline in the~     diagnosis of thyroid nodule with indeterminate cytology in order to guide the best indication~     of surgical resection.~   "
59794|NCT02784210|"~     Background:~      Multiple sclerosis (MS) affects the brain, spinal cord, and optic nerves. MS lesions can~     appear on the MRI (magnetic resonance imaging) scans in many ways. Sometimes they light up~     from the outer edge and fill inward. This is called ring enhancement. Researchers think this~     type of lesion may not heal as well as others. Corticosteroids are the standard treatment to~     reduce symptoms of MS relapse. But there is no standard treatment for people with enhancing~     MS lesions without signs of MS relapse. Researchers want to see if a short-term high-dose~     course of corticosteroids helps heal those lesions.~      Objective:~      To study the effects of short-term high-dose corticosteroids on ring-enhancing MS.~      Eligibility:~      Adults ages 25 and older who:~        -  Have MS and a rim-enhancing lesion on a prior brain MRI~        -  Are enrolled in another NINDS protocol~      Design:~      Participants will be screened under another protocol~      Participants will be randomly assigned to get either no treatment or 3 days of treatment with~     a corticosteroid.~      Participants will have:~        -  1 baseline visit~        -  3 dosing visits over 3 days if assigned to get treatment. Participants will get~          methylprednisolone by IV each day. They will get medicine to protect their stomach.~        -  1 visit each month for 7 months~      Visits include medical history and physical exam. Participants will have blood and urine~     tests. Participants will also have neurological exams and MRIs. Participants lie on a table~     that slides into a cylinder. They are in the scanner 1.5-2 hours. They get a dye through a~     catheter: A needle guides a thin plastic tube into an arm vein.~   "
59795|NCT02784184|"~     Minipuberty is a term used to describe the transient activation of the pituitary-gonadal axis~     2-3 months after birth in both boys and girls. It is, however, not known why infants reach~     adult levels of reproductive hormones in early life, nor is the exact timing of the peak~     known. Furthermore, what determines the timing of peaks and suppressions of reproductive~     hormones from infancy throughout childhood and into adolescence remains to be elucidated.~      The study aims to described and evaluate dynamic changes in the hypothalamic-pituitary-~     gonadal axis in early postnatal life.~   "
59796|NCT02784171|"~     Pembrolizumab is a new type of drug for mesothelioma (immunotherapy). Laboratory tests show~     that this drug works by helping improve the body's immune response to help fight cancer.~     Pembrolizumab may help the immune system to recognize cancer cells and slow down the growth~     and/or spreading of cancer.~   "
59797|NCT02784158|"~     The purpose of this study is to provide brigatinib for those patients with locally advanced~     and/or metastatic patients with ALK+ NSCLC on an expanded access basis due to their inability~     to meet eligibility criteria for on-going recruiting trials, inability to participate in~     other clinical trials (e.g., poor performance status, lack of geographic proximity), or~     because other medical interventions are not considered appropriate or acceptable.~   "
59798|NCT02784145|"~     The investigators will investigate the effects of an 8-week resistant starch (RS)~     supplementation (5 g twice a day) in patients with Parkinson Disease and matched controls on:~        1. symptoms of constipation (assessed by clinical scores);~        2. fecal short chain fatty acid concentrations (measured by chromatography);~        3. gut microbiota composition.~   "
59799|NCT02784132|"~     Fundoscopy is an important component of the neurological examination as it can detect~     pathologies such as high intracranial pressure. However, the exam can be challenging in~     uncooperative children. This study looked at whether playing a video during eye examination,~     improves the success, duration and ease of pediatric fundoscopy.~   "
59841|NCT02783586|"~     The main advantage of Quadratus Lumborum Block (QLB) compared to Transversus Abdominalis~     Plane Block (TAPB) is the impact on visceral pain due to the spread of the local anaesthetic~     agent to the paravertebral space. It may produce extensive analgesia and better pain control.~      Previews studies shoved the effectiveness of TAPB in kidney transplantation procedure (KTX)~     by reducing opioids requirements during and after the operation. QLB was not evaluating in~     KTX procedure yet, but it reduced postoperative morphine requirement after cesarean section~     under spinal anaesthesia.~      The aim of this prospective, randomised controlled, multicenter, clinical study is to compare~     the perioperative analgesic efficacy of QLB and TAPB in patients who had KTX under balanced~     (general and regional) anaesthesia.~   "
59800|NCT02784119|"~     The success of orthotopic liver transplantation (OLT) in treatment of liver malignancy and~     endstage liver disease has led to an increase in the gap between patients on waiting-lists~     and available liver grafts. In order to compensate for this scarcity, use of liver grafts~     harvested from extended criteria donors (ECD) has become more and more frequent.~      However, these ECD grafts are known to be associated with a higher rate of primary non~     function (PNF) or early allograft dysfunction (EAD) because of a greater vulnerability to~     ischemia-reperfusion injury (IRI).~      During OLT, the clamping of the portal vein induces blood congestion in the splanchnic~     territory leading to increased gut permeability, bacterial translocation and release of~     endotoxin and pro-inflammatory cytokines at revascularisation, which exacerbate IRI.~      Realisation of a temporary porto-caval shunt (TPCS) (i.e. end to side anastomosis between the~     portal vein and infrahepatic vena cava) during the anhepatic phase, avoids splanchnic~     congestion and could therefore decrease IRI and improve liver graft function. However, TPCS~     remains poorly used as no randomised trial succeeds to show its benefit on liver function due~     to lack of power.~   "
59801|NCT02784106|"~     M2951 is an investigational drug under evaluation for treatment of autoimmune and~     inflammatory disorders. The purpose of the study is to assess the efficacy of M2951 in~     participants with rheumatoid arthritis (RA) currently treated with stable dose of~     methotrexate (MTX).~   "
59802|NCT02784093|"~     Fecal impaction (FI) is a common cause of lower gastrointestinal tract obstruction, and it is~     the result of chronic or severe constipation and most commonly found in the elderly~     population. Gastrografin is a water soluble contrast mediate that could act as an osmotic~     laxative. It has been shown to confer a therapeutic beneﬁt in adhesive small bowel~     obstruction (SBO). The investigators speculate that gastrografin administrated orally may be~     more effective than enema in the treatment of fecal impaction induced intestinal obstruction.~   "
59803|NCT02784080|"~     The aim is to evaluate the impact of donor specific HLA alloantibodies (DSA) on all-cause~     mortality and re-transplantation, early allograft dysfunction, acute and chronic rejection,~     fibrosis, vascular, and biliary complications. Furthermore, all biopsies will be C4d stained.~     The hypothesizes is that donor specific HLA alloantibodies facilitate an immune mediated~     damage to the liver allograft that impairs function and lead to various complications.~      The investigators will do a prospective blinded multicenter cohort study in the~     Scandiatransplant organ sharing organization region.~      Both preformed, persistent, and de novo donor specific HLA alloantibodies will studied. Blood~     samples will be taken immediately prior to transplantation, and 14 days, 3 months, and 1 year~     after transplantation. All liver biopsies performed during the study period will be evaluated~     for a humoral component and blood samples will be obtained prior to liver biopsies to~     investigate the presence of DSA.~      Investigations will be fully blinded for the treatment responsible doctors.~   "
59804|NCT02784067|"~     S09A is a Phase 4, multicenter, randomized, double-blind, placebo-controlled, parallel study~     examining the efficacy and safety of a Sucraid (sacrosidase) Oral Solution in comparison to a~     placebo in 150-200 subjects with chronic diarrhea possibly attributable to sucrase~     deficiency.~   "
59805|NCT02784054|"~     The purpose of this study is to evaluate the outcome of intracranial non-germinomatous germ~     cell tumor (NGGCT) treated with reduced radiotherapy following high dose chemotherapy and~     autologous stem cell transplantation (HDCT/auto-SCT).~   "
59806|NCT02784041|"~     The purpose of this study is to compare the effect of single adductor-canal-block versus~     single femoral nerve block on the recovery after total knee arthroplasty.~   "
59807|NCT02784028|"~     The digestive cancer is the second cause of death worldwide. The presence of peritoneal~     carcinomatosis is common in the evolution of this type of cancer, as well as increased levels~     of ACE. This peritoneal carcinomatosis is often underestimated, this being due to low~     sensitivity detection means.~      In recent years, it has been shown that peritoneal carcinomatosis surgery as complete as~     possible associated with an intraperitoneal chemotherapy gave better results but still~     failures associated with the presence of microscopic residual tumors.~      The use of SGM -101 (developped by SURGIMAB SAS) allows surgeons to detect tumor nodules of~     small size very easily, in real-time, during surgery (shown in animals).~   "
59808|NCT02784015|"~     To evaluate the treatment outcome of unresectable soft tissue sarcoma using response based~     treatment~   "
59809|NCT02784002|"~     The purpose of this research study is to evaluate the safety and effectiveness of~     Ridinilazole (SMT19969) in treating C. difficile Infection (CDI).~   "
59810|NCT02783989|"~     The present study will assess whether the beneficial effects of a market moderate-alcohol~     drinking in the form of white wine in humans could be derived from the endogenous formation~     of hydroxytyrosol (also known DOPET), a potent dietary anti-inflammatory and antioxidant~     molecule.~   "
59811|NCT02783976|"~     This study will collect and evaluate information on the safety and efficacy of Sovaldi-based~     regimens in routine clinical practice in Mexico. The primary objective of this study is to~     assess the rates of serious adverse events/reactions (SAEs/SADRs) and adverse~     events/reactions (AEs/ADRs) in adult participants with chronic hepatitis C virus (HCV)~     infection treated with Sovaldi in routine clinical practice.~   "
59812|NCT02783963|"~     The purpose of this study is to evaluate the prevalence and morphological features of~     coronary plaques by means of OCT in patients with acute myocardial infarction but without any~     significant coronary stenosis at coronary angiography. In addition, cardiac magnetic~     resonance imaging (CMR) will be performed to assess the prevalence, location, and pattern of~     myocardial injury as well as other concomitant findings. As a secondary analysis, the~     association between the distribution and characteristics of coronary plaques detected on OCT~     and myocardial injury shown by CMR will be evaluated. In addition, a post-hoc survey~     regarding the potential modification of the interventional treatment approach based on OCT~     analysis will be conducted.~   "
59813|NCT02783950|"~     To determine the impact of Decipher test results on adjuvant treatment decisions of high-risk~     post-RP patients with undetectable post-op prostate specific antigen (PSA) compared to~     clinical factors alone.~   "
59814|NCT02783937|"~     Filgrastim is a Granulocyte-Colony Stimulating factor (G-CSF). It is an FDA approved drug.~     Very small embryonic-like stem cells (VSELs) are found in the ovary. Animal studies showed~     that these cells are able to regenerate the affected ovary. Studies on mice have shown that~     Filgrastim result in recovery of oogenesis after chemotherapy-induced gonadal failure (in~     2013, 2014, and 2015).~   "
59817|NCT02783898|"~     Palpitations (noticeable pounding, fluttering or irregular heart beat) and pre-syncope (near~     blackout) are common ED problems sometimes due to an abnormal cardiac rhythm. This is~     difficult to diagnose as examination and electrocardiogram (ECG) are commonly normal and~     symptoms have usually resolved by the time the patient arrives in the ED. Diagnosing an~     abnormal heart rhythm as the cause of symptoms rests on capturing it on an ECG and patients~     are usually discharged with advice to return to the ED again for a 12-lead ECG should~     symptoms recur. The investigators will recruit 242 adult participants to either study or~     control arms. All study arm participants will be given an AliveCor Heart Monitor and trained~     in the use of the device. Control arm participants will receive standard care only. Both~     groups will be followed-up at 90 days. The investigators believe a smart phone based event~     recorder will allow better and earlier diagnosis in patients with a compatible smart phone or~     tablet, and revolutionise ED care in this area.~   "
59818|NCT02783885|"~     The efficacy and safety of different medications vary from one individual to another and from~     one ethnic group to another. Therefore, strong interest in the study of pharmacogenomic and~     pharmacoepidemiology has evolved recently.~      There are multiple examples of oncology drugs being more effective in certain ethnic~     population compared to other. For example, irinotecan combined with cisplatin was very~     effective drug in the management of small cell lung cancer in the Japanese patients while an~     identical study done in the US revealed no major benefit to this combination in American~     population~   "
59819|NCT02783872|"~     This study will investigate neural activation patterns in emotion- and cognition-related~     brain regions during an emotion regulation task involving cognitive reappraisal, and their~     associations with age and pubertal status, among overweight children and adolescents with~     loss of control eating as compared to overweight and normal-weight controls.~   "
59820|NCT02783859|"~     An intervention study to determine if a longer duration of antibiotics (compared to shorter~     duration) improves the short and long term clinical outcomes of children hospitalised for~     pneumonia~   "
59821|NCT02783846|"~     The purpose of this study is to evaluate the effects of different dexmedetomidine on the~     propofol requirement for loss of consciousness undergoing bispectral index.~   "
59822|NCT02783833|"~     Pharmacodynamic profiling will also be studied to characterize the effects of MMV390048 on P.~     falciparum clearance kinetics in healthy subjects using the Induced Blood Stage Malaria~     (IBSM) challenge model to determine the minimum inhibitory concentration of MMV390048 for P.~     falciparum (Part B).~   "
59823|NCT02783820|"~     This Phase I study will evaluate the safety, tolerability and pharmacokinetic properties of~     escalating single doses of reformulated MMV390048 when administered to healthy men and women~     of non-childbearing potential (WNCBP) under fasted conditions (Part A).~   "
59824|NCT02783807|"~     This prospective equivalency study compares the performance of two Ophthalmic Cameras, the~     Eyenez Retina Ophthalmic Camera v200 (OC) and the Optomed Smartscope M5 EY3 (OP). Trained~     technicians will take pictures of the same patients' retinas and the quality of the photos~     will be evaluated. The study includes healthy patients and patients with a spectrum of~     retinal diseases. The study requires that technicians take pictures of the retinas of adult~     patients between 18 and 80 years of age using both the OC and OP. The pictures will be~     reviewed and compared by a central reader/Ophthalmologist, who will determine if the OC is~     equivalent to the OP, based on the quality of the images~   "
59825|NCT02783794|"~     The purpose of this study is to determine whether BP-C1 is effective in the treatment of~     metastatic breast cancer patients who had previously received at least three lines of~     chemotherapy.~   "
59826|NCT02783781|"~     In cardiac surgery, the assessment of operative risk and quality of care is a major challenge~     for both patient, and surgical team. It is also important for health care decisionmakers to~     have predictive tools to compare alternative technics such as conventional cardiac surgery~     and interventional cardiology. Since 1998, the European System for Cardiac Operative Risk~     Evaluation (EuroSCORE), updated in 2012 (EuroSCORE II) is the most universally used system in~     this purpose. Its success is the result of a good balance between predictive capability and~     simplicity. It consists almost exclusively of clinical variables.~      However, the objectivity and the predictive ability of some of those clinical items remain~     controversial, particularly those addressing severity of illness for high-risk patients. For~     instance, the degree of priority is submitted to the subjective assessment by the surgical~     team at the time of surgery. Objective data describing the severity of patients arriving in~     the operating room are still missing.~      Many biomarkers are relevant in qualifying severity of syndromes: shock (PH, lactates, LDH),~     heart disease (N-terminal pro b-type natriuretic peptide (NTproBNP), troponin T and I),~     respiratory disorder (blood gaz analysis), liver insufficiency (TP, factor V), renal~     impairment (serum creatinine, creatinine clearance), inflammatory condition (fibrinogen,~     CRP), or the underlying medical condition such as diabetes (HbA1c, microalbuminuria) and~     nutritional status (albumin).~      In ICU, many scores use biological data to measure, on daily basis, the severity of the~     patient status. Their routine use is simplified by applications available on smartphones.~     They are drawn into hospital information systems.~      In cardiac surgery, some studies seem to demonstrate the measurement of some preoperative~     biological variables (eg NT Pro-BNP ...) in risk prediction. In terms of diabetes, HbA1c is~     of particular interest because it detects underlying diabetes if unknown (emergent situation)~     or reflects its poor control before surgery. This criterion could be more reliable than the~     simple information of patient treated by insulin (EuroSCORE II criterion).~      Finally, the reinforcement of existing scores with biological variables is recommended by the~     group of recommendations in prognostic research strategy (PROGRESS 2014), rather than~     creating new scores ex nihilo.~      The hypothesis is that adding biological data collected at the time of arrival of the patient~     in the operating room would better qualify the patients' severity condition and therefore~     increase the risk prediction of early mortality and severe morbidity after cardiac surgery.~     The purpose of this study is to test this hypothesis and especially test whether the~     biological data would increase the EuroSCORE II performance, by improving the prediction for~     high-risk patients.~   "
59827|NCT02783768|"~     Determination of the acute pulmonary toxicities of e-cigarettes in young adults is of major~     public health importance, as e-cigarette vapor contains established toxicants that as~     hypothesized cause acute damage to the airways and the pulmonary microvasculature that may~     promote the development of CLD, for which there remain few effective therapies.~      The study therefore propose a pilot study using a randomized crossover design in ten healthy~     young adults to test the acute effects of a standardized e-cigarette exposure on two~     sensitive, safe, non-invasive imaging measures: (1) ventilation defects on hyperpolarized~     helium-enhanced magnetic resonance imaging, and (2) pulmonary microvascular blood flow on~     gadolinium-enhanced pulmonary magnetic resonance angiography.~   "
59842|NCT02783573|"~     The main purpose of this study is to evaluate the efficacy of the study drug known as~     lanabecestat in participants with mild Alzheimer's disease (AD) dementia.~   "
60046|NCT02780882|"~     The purpose of this prospective open-label phase II study, is to evaluate the efficacy of~     pasireotide twice daily subcutaneous injections for normalizing 24 hour urine free cortisol~     in patients with ectopic ACTH-producing tumors as measured by the proportion of patients~     achieving normal UFC at the end of the study period.~   "
59828|NCT02783755|"~     The purpose of this study is two-fold. First, the investigator will develop a low-literacy~     Mobile Pain Coping Skills Training (mPCST) protocol for cancer patients with pain (i.e.,~     therapist manual, patient manual including handouts, and the smartphone materials) as well as~     a beta version of the basic smartphone components with the assistance of experts in the~     field. Next, an iterative development design using focus groups with women who have breast~     cancer and pain accrued from medically underserved areas will be used to refine the developed~     mPCST protocol and basic smart phone components. The protocol—designed to reduce cancer pain~     and disability in patients with low literacy in medically underserved areas—will be delivered~     via tele-video conferencing sessions in the community clinic. The smartphone tools (e.g.,~     simple text messages, images, and preloaded intervention content) will allow the intervention~     to extend into the patients' homes. The second study purpose is to pilot test the~     feasibility, acceptability, and efficacy of the developed protocol. The investigator will~     also obtain an estimate of the effect size of the developed protocol to decrease pain. Focus~     group data will be managed and evaluated in a systematic format using a grounded theory~     approach. Data analyses for the pilot testing period of the study will be assessed by~     examining accrual, attrition, and adherence to the intervention. Simple t-tests will be used~     to examine pre- to post-intervention differences in pain and the other outcomes of interest.~     There are minimal risk or safety issues related to this study.~   "
59829|NCT02783742|"~     To examine the effect of a coaching intervention on provider burnout and communication~   "
59830|NCT02783729|"~     This study will be conducted to demonstrate, using polysomnography, that lemborexant 10~     milligrams (mg) and 5 mg is superior to placebo on objective sleep onset as assessed by~     latency to persistent to sleep (LPS) after the last 2 nights of 1 month of treatment in~     participants 55 years and older with insomnia disorder.~   "
59831|NCT02783716|"~     The goal of this study is to determine the role of vascular endothelial function in heart~     failure (HF) and the effect of cardiac resynchronization therapy (CRT) on endothelial and~     cardiac function.~   "
59832|NCT02783703|"~     The study team will investigate the racial differences in the metabolic and clinical~     responses to Medium chain triglycerides (MCT) between African American and Caucasian American~     subjects with Metabolic Syndrome.~   "
59833|NCT02783690|"~     This is an open label phase II randomized controlled trial to determine the safety of 15~     fraction vs 25 fraction pencil beam scanning proton radiotherapy after mastectomy in patients~     requiring regional nodal irradiation. Proton therapy is recognized as a standard option for~     the delivery of radiotherapy for breast cancer.~   "
59834|NCT02783677|"~     Peripheral artery disease (PAD) is highly prevalent. It occurs most often in the lower~     extremities. Symptoms include intermittent claudication, ischemic pain, ulceration and~     necrosis. Amputation may be necessary in severe cases. PAD is also an indicator of future~     cerebrovascular and cardiovascular events. Diabetes mellitus (DM) is one of the major risk~     factors of PAD. Approximately 5% to 10% of diabetic patients have had foot ulceration, and 1%~     have undergone amputation. Other risk factors include smoking, old age, male gender,~     hypertension, dyslipidemia, hyperhomocysteinemia and renal insufficiency. Ankle-brachial~     index (ABI) is the most popular tool used to screen PAD. Doppler-derived ankle and brachial~     systolic pressure is obtained. If the ratio is abnormal, further confirmation studies will~     necessary. Although ABI is recommended as one of the screening tests for diabetic~     complications in guidelines, its utility is limited in calcified non-compressible vessels,~     which are common in DM and renal failure patients.~      Digital infrared thermal imaging (DITI) is used to detect surface temperature because objects~     of absolute temperatures higher than zero would radiate electromagnetic waves of certain wave~     lengths according to Plank's law. DITI examination is non-invasive, non-contact and fast.~     Theoretically, temperature of the perfusion area of the occlusive arteries will decrease.~     Investigators will analyze DITI of PAD, and observe the relationship between DITI, ABI and~     vascular duplex examination. The dynamic change of DITI before and after percutaneous~     transluminal angioplasty of PAD will also be observed. Investigators would like to evaluate~     the possibility of the clinical application of DITI for PAD screening.~   "
59835|NCT02783664|"~     This prospective Medical College of Wisconsin Cancer Center study will evaluate stress levels~     in breast cancer patients undergoing genetic testing. It aims to establish baseline stress~     levels, evaluate pre- and post-test stress levels at multiple time points, focus on the~     changes in stress levels for the different resulting subgroups. This will help the clinical~     staff to provide better care for patients both medically and psychologically through~     potential interventions to decrease stress.~   "
59836|NCT02783651|"~     A retrospective chart review study of Philadelphia chromosome-negative R/R ALL patients in~     the US.~   "
59837|NCT02783638|"~     This study is to assess the pharmacokinetics of Pregabalin controlled release formulation~     after multiple dosing as compared to Pregabalin immediate release formulation and the food~     effect of high fat diet after single dosing in healthy male volunteers.~   "
59838|NCT02783625|"~     The purpose of this study is to test the safety of a study drug called duvelisib.~   "
59839|NCT02783612|"~     Assessing blood glucose control in women with gestational diabetes can be challenging. The~     standard of care remains visual inspection of blood glucose paper diaries of self-performed~     capillary monitoring during regular meeting in High Risk pregnancy clinics.~      The researchers are interested in preforming a randomized control trial comparing women with~     the diagnosis of gestational diabetes with regular High-Risk clinic surveillance to digital~     monitoring using an application in a Smart-phone and submitting those values via email in~     addition to the regular clinic appointments.~      The Primary outcome of the trial is to assess the compliance of the research group as~     compared to the control group.~   "
59840|NCT02783599|"~     The purpose of this study is to evaluate potential biomarkers and method of action, efficacy~     and safety of olaratumab in participants with soft tissue sarcoma (STS).~   "
59886|NCT02782988|"~     CMV lesions were found in the olfactory system of children with congenital CMV infection but~     no study has hitherto examined the impact of congenital CMV infection on olfaction. So the~     investigators propose in this study to assess the proportion of children with olfactory~     deficits among children with congenital CMV infection. Second this study will also evaluate~     performances of a new olfactory test, based on discrimination of binary odorant mixtures.~   "
59843|NCT02783560|"~     Despite the high prevalence of sleep difficulties in children with disruptive behavior~     disorders, little is known about the role of sleep in treating disruptive behavior. The~     current study evaluates the addition of a sleep intervention to an existing parent-training~     program for caregivers of children ages 3-8 with disruptive behaviors. Objectives are to~     examine the impact of a novel sleep treatment program on sleep, disruptive behavior, and~     other measures of family functioning, utilizing a variety of self-report and objective~     measures (e.g. actigraphy, electrodermal activity). The investigators hypothesize that sleep~     intervention will result in improvements in sleep and disruptive behavior compared to control~     group receiving a highly plausible addition to the standard parent training intervention, and~     that sleep outcomes will moderate overall treatment success.~   "
59844|NCT02783547|"~     This is a Phase 1 clinical trial to evaluate the tolerability of a combination therapy of SyB~     C-1101 (rigosertib sodium) and Azacytidine and to determine the recommended dose of SyB~     C-1101for Phase 2 trial in patients with myelodysplastic syndrome.~   "
59845|NCT02783534|"~     Primary dysmenorrhea (PD) is a common complaint in menstruating women. Although nonsteroidal~     anti-inflammatory drug is an effective treatment, there are concerns about serious adverse~     events. Complementary therapies, including acupuncture, are commonly used for PD. Acupuncture~     has a low risk of adverse effects, while the evidence for the effectiveness of acupuncture in~     treating PD is inconclusive. Deqi and psychological factors are core concepts in acupuncture~     theory, but they have been largely neglected in primary dysmenorrhea clinical reports. The~     objective of this trail is to assess the clinical efficacy of acupuncture in the prevention~     of PD and investigate what factors will affect the efficacy of acupuncture.The results of~     this trial will significantly add to the current body of evidence on the role of acupuncture~     for PD. If found to be effective and safe, acupuncture will be a valuable treatment option in~     the prevention of PD. In additional, results from this trial will identify what factors will~     affect the efficacy of acupuncture.~   "
59846|NCT02783521|"~     The investigators propose to 1) assess the feasibility, acceptability and preliminary~     efficacy of a gender- and culturally-sensitive weight loss intervention in 48~     overweight/obese Hispanic males ages 18-64 over 12 weeks; 2) assess participant~     characteristics and process measures related to the uptake of mobile-health (mHealth)~     technology in overweight/obese Hispanic males over 12 weeks; and 3) assess pathologic changes~     in the liver in Hispanic men enrolled in a 12-week weight loss intervention using a~     non-invasive MRI as a therapeutic response biomarker.~   "
59847|NCT02783508|"~     Systematic opioids and inhaled nitrous oxide (N2O ) are common methods for pain relief during~     labor. The aim of the current study is to evaluate the efficacy of systemic pethidine~     compared to N2O given for pain relieve in term, multiparous women in labor.~   "
59848|NCT02783495|"~     This pilot trial of this iPad-based intervention in glioma patients at University of~     California, San Francisco (UCSF) will establish feasibility and preliminary efficacy data to~     support a funding application for a larger clinical trial. Twenty patients with stable~     low-grade gliomas will complete a computerized battery of standardized neurocognitive tests~     and quality of life assessments at baseline. Subjects will complete the intervention at home~     over 3 months. Neuro-cognitive testing will be repeated 3 and 9 months after baseline.~     Subjects will also complete a post-intervention questionnaire on the usefulness,~     attractiveness, difficulty and burden of the intervention. Clinical data will be collected at~     the time of each assessment. This will include diagnostic and treatment history, magnetic~     resonance imaging (MRI data), tumor genomics and immunohistochemistry.~   "
59849|NCT02783482|"~     The purpose of this study is to evaluate the safety, efficacy and Pharmacokinetics of Immune~     Globulin Intravenous (Human) GC5107 in subjects with Primary Humoral Immunodeficiency (PHID).~   "
59850|NCT02783469|"~     In 1997, the global prevalence of diabetes was estimated to be 125 million and this has risen~     to around 400 million in 2015. In addition diabetes has a number of complications including~     heart disease, blindness, kidney failure and amputation. This represents a significant burden~     on healthcare services. Type 2 diabetes (T2D) is caused by a combination of genetic and~     environmental factors. The aim of GoDARTS is to recruit participants with T2D to a registry~     to provide a platform with which to investigate the genetics of T2D, its complications and~     response to treatment. This study will investigate the genetic basis of diabetic neuropathic~     pain.~   "
59851|NCT02783456|"~     Epidemiological studies have found a link between aircraft noise exposure and increased~     incidence of arterial hypertension and thus cardiovascular disease. The underlying~     pathophysiological mechanisms are not yet fully understood. The kidney acts as a long-term~     regulator of blood pressure and controls the extracellular sodium and water balance.~     Significant renal mechanisms of blood pressure regulation are the renin angiotensin system,~     renal sympathetic activity and sodium excretion. Animal work and clinical studies show that~     mental stress affects the renal plasma flow and urinary sodium excretion. The investigators~     observed a lower sodium excretion in situations of mental stress in subjects at risk for~     developing arterial hypertension. In healthy volunteers, a 30-minute mental stress test~     resulted in increased glomerular filtration rate, filtration fraction and an increase in~     urinary sodium excretion. In this pilot study the investigators analyzed the influence of 30~     minutes standardized aircraft noise on renal and central hemodynamics.~   "
59852|NCT02783443|"~     Observational study evaluating effect general or regional anaesthesia on glycocalyx by using~     perfused Boundary Region in sublingual microcirculation.~   "
59853|NCT02783430|"~     KetaPal is a placebo-controlled randomized trial designed to demonstrate the antidepressant~     action of ketamine in palliative care situations. Half of participants will receive Ketamine~     and Milnacipran in combination, while the other half will receive a Placebo and Milnacipran~     in combination.~   "
59887|NCT02782975|"~     The primary objectives of this study are to evaluate the absolute bioavailability of a~     single, fixed sub-cutaneous (SC) dose of aducanumab compared with a single, weight-based~     intra-venous (IV) dose in healthy participants and to characterize the pharmacokinetics (PK)~     profile of aducanumab. The secondary objectives are to evaluate the safety and tolerability~     of aducanumab administered via SC and IV routes in healthy participants and to characterize~     additional PK parameters of a single, fixed SC dose of aducanumab and a weight-based IV dose~     in healthy participants.~   "
59854|NCT02783417|"~     The use of antiretroviral therapy (ART) could prevent depression of the immune system of~     patients harboring with Human Immunodeficiency Virus (HIV), providing increased life~     expectancy, changing the classification of HIV / AIDS into a chronic illness. However~     prolonged use of ARTincreases the prevalence of lipodystrophy syndrome (SL), characterized by~     inadequate distribution of body fat and changes in lipid profile, associated with a~     significantly increased cardiovascular risk, among others. The practice of strength training~     (ST) helps in controlling SL, providing improved lipid profile and the quality of life of~     these patients. However, due to increased cardiovascular risk and physical weakness resulting~     from SL, the ST with vascular occlusion (STOV) could be a viable alternative training, to use~     low load (10-30% of maximal work capacity) with similar benefits ST traditional (STT), as~     already proven in other populations. The STOV is justified by the lower neuromuscular~     overhead, increasing the number of patients able to participate in this complementary~     therapy. The objective was to assess the impact of the combined strength training with~     vascular occlusion on SL and the skeletal muscle tissue in people harboring with HIV/Aids.~   "
59855|NCT02783404|"~     Although controversy exists regarding the efficacy of antibiotic prophylaxis for patients at~     risk of infective endocarditis, expert committees continue to publish recommendations for~     antibiotic prophylactic regimens. Recently, the investigators have evaluated the efficacy of~     the intravenous administration of 1000/200 mg of amoxicillin/clavulanate for the prevention~     of bacteraemia following dental extractions. The results of this study suggest that is highly~     effective, and that it might be considered a first-line choice for patients at high-risk for~     infective endocarditis who undergo dental procedures and for whom antimicrobial prophylaxis~     is recommended. This new project aims to evaluate the effectiveness of oral~     amoxicillin/clavulanate in preventing post-dental extraction bloodstream infection.~   "
59856|NCT02783391|"~     New method for speech area cartography in patient individual cortical anatomy in view of~     improving functional area limit preservation during surgery.~   "
59857|NCT02783378|"~     At a esophagal pH-monitoring will the classic 24-hour measurement be extended to 48 hours.~     During the first 24 hours are the measurements without medication. After 24 hours the~     treatment will be started with Gaviscon and will the next 24 hours the measurements under the~     medication happen. Normally is the medication required after the measurements. With this~     study the investigators will have multiple measurement points to compare.~   "
59858|NCT02783365|"~     There are an estimated 100 million Americans with chronic pain. The enormity of the problem~     at the societal level is staggering, not simply in terms of its sheer prevalence but also the~     societal costs, including health care expenditures, disability compensation, lost~     productivity, and lost employment potential. The pharmacological focus in treatment tends to~     give patients with chronic pain a negative stereotype as many are viewed as drug seeking, or~     worse, they are perceived to have an imaginary illness. It is argued that these stigmas not~     only negatively affect the patients' healthcare experience, but also perpetuate maladaptive~     coping. In addition, it is suggested that reliance on pharmacological approaches have~     contributed to the rate of overdoses from prescribed opioids. In order to address this burden~     facing society, patients need opportunities to foster a sense of self-efficacy to manage~     their pain, as well as improve their healthcare experience by allowing them to dialogue with~     their clinician openly and freely about their chronic pain, and coping strategies.~      This study is designed to explore the impact of an intervention using photo-elicitation~     (based on Photovoice) and online group support (via Facebook) on participants' overall~     experience of chronic pain and patient-identified areas of function. Photovoice participants~     will utilize cameras that enable them to record issues related to their experiences, and~     subsequently display them. This method serves as an empowering tool to connect participants~     to key stakeholders in the community, facilitates change and opportunities that otherwise~     would not be available to marginalized groups.~   "
59859|NCT02783352|"~     Increasing the success rate of rotator cuff healing remains a tremendous challenge for~     orthopedic surgeons, which encourage the development of new biological therapies. Among many~     approaches, activating resident progenitor cells with the Lipogems® product could be an easy,~     safe, practical and cost-effective new therapeutic strategy for increasing rotator cuff~     tendon healing.~      The primary goal of this study is to evaluate efficacy of infiltration of autologous~     micro-fragmented adipose tissue in arthroscopic rotator cuff repair, in terms of gain in~     post-operative Constant score.~   "
59860|NCT02783339|"~     The primary objective of this study is to demonstrate effectiveness and safety of the~     NeuroForm Atlas stent system for use in patients requiring stent assisted intracranial~     aneurysm treatment.~   "
59861|NCT02783326|"~     Chronic obstructive pulmonary disease (COPD) is a condition in which the lung is in chronic~     state due to an inflammatory response that leads to limitation in lung function of the~     individual, providing symptoms such as dyspnea, nutritional changes, decreased strength~     respiratory muscle, low capacity to exercise, dynamic insufflation and altered autonomic~     function with decreased heart rate variability. Have objective to evaluate and compare the~     effects of a rehabilitation protocol on autonomic modulation of heart rate. Participate in~     the study, 10 volunteers with COPD and 10 apparently healthy individuals, of both sexes,~     between 50 and 70 years old. Data collection and application of the Protocol will take place~     at the Clinical School of Physiotherapy and Occupational Therapy at the University of the~     Amazon (UNAMA). Between January and February 2015.~   "
59862|NCT02783313|"~     The objective of this study is to determine if pooled buffy coat-derived pathogen reduced~     plasma-stored platelet concentrates are non-inferior compared to plasma-stored platelet~     concentrates in terms of WHO bleeding complications in hemato-oncological patients with~     thrombocytopenia.~   "
59888|NCT02782962|"~     This study evaluate the diagnostic accuracy of a simplified clinical algorithm (STANDING) for~     the differential diagnosis of acute vertigo in the emergency department.~      In particular, the investigators want to analyze the sensitivity and specificity of the test~     for the diagnosis of vertigo of central origin and the reproducibility of the test.~      In suspected central vertigo of ischemic origin, a duplex sonography to identify vertebral~     artery pathology will be performed.~   "
59889|NCT02782949|"~     This randomized phase IIb trial studies how well curcumin works in preventing gastric cancer~     in patients with chronic atrophic gastritis and/or gastric intestinal metaplasia. Curcumin is~     an antioxidant compound found in plants that may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth.~   "
59863|NCT02783300|"~     The study drug, GSK3326595, is an inhibitor of protein arginine methyltransferase 5 (PRMT5)~     that potently inhibits tumor growth in vitro and in vivo in animal models. This first time in~     human (FTIH), open-label, dose escalation study will assess the safety, pharmacokinetics~     (PK), pharmacodynamics (PD), and preliminary clinical activity of GSK3326595 in subjects with~     advanced or recurrent solid tumors, as well as clinical activity in subjects with a subset of~     solid tumors and non-Hodgkin's lymphoma. This is an open-label, repeat-dose, multicenter,~     2-part study to establish the maximally tolerated dose (MTD)/ recommended phase 2 dose (RP2D)~     based on safety and tolerability and preliminary clinical efficacy of orally-administered~     GSK3326595. Part 1 is a dose-escalation phase to identify the MTD/RP2D based on the safety,~     PK, and PD profiles observed after oral administration of GSK3326595. This Part will be~     conducted in adult subjects with relapsed and/or refractory solid tumors. It is estimated~     that up to 50 subjects will be enrolled into the dose escalation cohort of the study,~     including up to 38 subjects to identify the MTD and approximately 12 subjects in the~     PK/PD/metabolite/biomarker expansion cohort(s). Disease-specific expansion cohorts (Part 2)~     are planned to further explore clinical activity of GSK3326595 in subjects with selected~     solid tumors and non-Hodgkin's lymphomas. It is estimated that up to 150 subjects will be~     enrolled in the disease-specific expansion cohorts of the study. The duration of study will~     depend on recruitment rates and the timing of subjects' duration on study (withdrawal rates~     due to toxicity or progression), with an approximate duration of 2 years.~   "
59864|NCT02783287|"~     The purpose of this study is to assess the impact of text message reminders on adherence to~     medications and exercise in patients recently discharged from the hospital after a myocardial~     infarction (MI).~   "
59865|NCT02783274|"~     Two-year (2 year) information regarding the performance of the commercially available Actis™~     Total Hip System in order to obtain and evaluate the clinical outcomes on a series of~     cementless primary total hip arthroplasty (THA) and hemi-hip arthroplasty procedures using~     clinical, radiographic and device and procedure related adverse event assessments.~   "
59866|NCT02783261|"~     Patients undergoing Y90 radioembolization to will be followed prospectively with CT volumetry~     to determine post-Y90 rate of liver hypertrophy.~   "
59867|NCT02783248|"~     The aim of this study is to validate prospectively the predictive score of late results about~     a diverse population recruited in France and to evaluate the contribution in predicting the~     outcome of the PMC scanner to study the mitral calcium score and the location of the~     calcifications.~   "
59868|NCT02783235|"~     This study aims at creating video-based tutorials for developing skills in performing~     cervical cancer screening using VIA for the Auxillary Nurse Midwives (ANMs), Accredited~     Social Health Activists (ASHAs) and Primary Health Workers (PHWs). Cervical cancer screening~     is mainly done by the following three methods: Visual inspection with acetic acid (VIA),~     Cervical Smear Cytology (PAP) and HPV DNA test. VIA is a low cost, low resource cervical~     cancer screening method and especially useful for low middle income countries (LMICs) like~     India.~      We propose to develop video-based tutorials, such that the ANMs/ASHAs/PHWs could be trained~     in performing and interpreting VIA with the use of this tutorial. The ANMs/ASHAs/PHWs have~     important roles in delivering health in rural/ semi urban areas and they will be trained~     using this tutorial.~      The video-based tutorials will be made according to the 'Spoken Tutorials' methodology,~     developed at IIT Bombay. Video-based Tutorials has given skills based training to over 2 lakh~     students in the past four years on IT based topics. The tutorials are made available online~     free of cost. They are designed to be used without the need of an expert being physically~     present.~   "
59869|NCT02783222|"~     This is a randomized study evaluating the efficacy and impact on function of two different~     doses of nab-Paclitaxel in elderly patients with advanced breast cancer.~   "
59870|NCT02783209|"~     This study evaluates the association between surgery of the cataract and posterior vitreous~     detachment, in the emmetropic patient, by comparing eyes operated with eyes not operated in~     the same group of patients~   "
59871|NCT02783196|"~     This study is undertaken to search whether glucagon-like peptide-1 (GLP-1) analogue,~     Liraglutide, by enhancing clock gene and AMPK-SIRT-1 mRNA expression, may reverse the~     metabolic abnormalities of type 2 diabetes, improving overall glycemic excursion,~     inflammatory cytokines and β-cell function in type 2 diabetes individuals.~      The investigators aim is to compare the effect of 40 days treatment with Liraglutide (LIR)~     vs. 40 days with placebo (PLA) in T2D participants on the following end points:~      Primary end-points:~        -  Change in the oscillation of CG (i.e. CLOCK, BMAL1, Per1, Per2, Cry1, Cry2,~          Rev-erb-alpha Ror-alpha), AMPK, SIRT1 and inflammatory cytokines mRNA expression in~          white blood cells (WBCs).~      Secondary end-points:~        -  Overall daily glycemic variation assessed with continuous glucose monitoring system~          (CBMS)~        -  Serum levels of inflammatory cytokines (TNF-α, IL-1β, IL-6)~        -  β-Cell function derived from glucose and insulin response to OGTT~   "
59872|NCT02783183|"~     The purpose of this trial to compare the pharmacokinetic characteristics of~     YHD1119(Pregabalin 300mg) and Lyrica capsule(Pregabalin 150mg). YHD1119 is controlled release~     formulation which is made by Yuhan Corporation. Primary endpoints are Cmax,ss and AUCtau and~     secondary endpoints are AUClast,ss, AUCinf,ss, Tmax,ss and t1/2.~   "
59873|NCT02783170|"~     This is a pilot, prospective, randomized, open-label clinical trial. During the study,~     pregnant women will be randomized (1:1) to receive co-administration of a single~     intramuscular (IM) 0.5 mL dose of US-licensed inactivated influenza vaccine (IIV) and a~     single intramuscular (IM) 0.5 mL dose of US-licensed Tetanus toxoid, reduced diphtheria~     toxoid and acellular pertussis vaccine adsorbed (Tdap) or sequential administration of the~     vaccines (IIV followed by Tdap ~ 21 days later). Vaccines will be administered by licensed~     study personnel.~      Prior Tdap/Td/TT and influenza vaccine history will be verified by medical record review when~     possible.~      Injection-site (local) and systemic reaction data will be assessed on vaccination day and~     during the 7 days following vaccination using either identical web-based or paper diaries,~     depending on study participant preference.~      Maternal serum samples will be collected for antibody titers relevant to the Tdap and~     Influenza at time points that include: prior to vaccination(s), ~21 days post vaccination(s),~     and at delivery. Additionally, cord blood serum will be analyzed for the same antibody~     titers.~      Pregnant women will be followed with comprehensive obstetric and neonatal outcomes obtained~     from medical record review.~   "
59874|NCT02783157|"~     In this study, the investigators aim to determine whether non-invasive autonomic modulation~     decreases inflammation and complications after thoracic surgery. The investigators will test~     the hypothesis that low-level transcutaneous vagal nerve stimulation (LLVNS) during major~     thoracic surgery reduces inflammation and complications, particularly postoperative atrial~     fibrillation (POAF). This will be a prospective randomized pilot trial of 200 patients~     undergoing major thoracic surgery including lobectomy, bilobectomy, or pneumonectomy via~     either video-assisted thoracoscopic (VAT) or open thoracotomy. Patients will be randomized to~     receive ether a) LLVNS (n=100) or b) sham LLVNS (n=100) during their procedure. All patients~     will receive standardized anesthetic, surgical, and post-surgical care. The primary outcome~     in this study will be time to occurrence of in-hospital POAF, which will be compared between~     groups using Cox proportional hazards models. Secondary outcomes will be ICU and hospital~     length of stay, postoperative morbidity, postoperative mortality, and serologic markers of~     inflammation.~   "
59875|NCT02783144|"~     Dexamethasone Added to Levobupivacaine in Ultrasound-guided Tranversus Abdominis Plain Block~     Increased the Duration of Postoperative Analgesia After Laparoscopic Cholecystectomy.~   "
59876|NCT02783131|"~     It is well known that medical errors account for a large amount of patient harm within the~     hospital setting. This is a significant problem within the emergency context. A system that~     acts as a prompt, guide and scribe for the obstetric emergency has been developed called~     'Mednav'. Mednav is a navigation device for the management of medical emergencies; developed~     at Chelsea and Westminster Hospital since 2010. This is a device which acts similar to a~     satellite navigation devices in the automobile industry navigating you from A to B, MedNav~     navigates the clinician from the unwell patient to the well patient.~   "
59877|NCT02783118|"~     Depression is one of the major challenges worldwide, with significant increasing personal,~     economic, and societal costs. Although empirically supported treatments have been developed,~     they are not always available for patients in routine clinical care. Even when patients are~     adequately treated, they do not always respond to treatment and/or face a significant risk~     for recurrence. Therefore, effective and wide accessible strategies to prevent the onset of~     the very first depressive symptoms are necessary. Mental health apps could prove a valuable~     alternative for that. Although preliminary research has indicated that apps could be useful~     in treating depression, no study has attempted to test their utility in preventing depression~     symptoms. The current study aims to contrast the efficacy of a smartphone app in preventing~     depression compared against a waiting list condition. The app includes self-help materials~     and exercises based on cognitive behavioral therapy (CBT) for depression, presented in a~     tailored manner and incorporating gamification elements aimed at boosting the motivation to~     use the app.~      This study protocol is the first that capitalizes on the ubiquity of smartphones to~     large-scale dissemination of CBT-based strategies aimed at preventing depression in~     nonclinical populations. The objective of this study is to test an app designed to decrease~     general cognitive vulnerability and promote engagement in protective, adaptive activities,~     while counteracting the tendency of premature dropout (through gamification and~     customization).~   "
59878|NCT02783105|"~     Paroxysmal sympathetic hyperactivity (PSH) is a frequent symptom after traumatic brain injury~     and concerns up to 30% of severely brain-injured patients.~      PSH is due to unbalanced autonomic nervous system activity, resulting in sympathetic surges~     causing hypertension, tachycardia, sweating and hypertonia. The affected patients suffer more~     pain, more cardiovascular distress, more infections and prolonged rehabilitation and~     mechanical ventilation; additionally it could lead to a worse outcome.~      Classical music was shown to reduce autonomic nervous system imbalance in healthy people and~     in many medical diseases. It could be a means to dampen sympathetic surges for brain-injured~     patients presenting with PSH, as well.~      Our study aims at demonstrating that early musical intervention, started with the weaning of~     sedation, can reduce both the prevalence and the severity of paroxysmal sympathetic~     hyperactivity in traumatic brain-injured patients.~   "
59879|NCT02783092|"~     The purpose of this study is to assess the efficacy of the adjuvant use of cannabidiol~     administered twice daily in doses of 5-25 mg/kg/day through the proportion of responsive~     patients; that is, participants with at least 50% decrease in the frequency of epileptic~     seizures in the last month of the trial relative to baseline (pretreatment with AEDs only).~      Primary end point(s): Rate of responsive patients; that is, participants with at least 50%~     decrease in the frequency of epileptic seizures in the last month of the trial relative to~     baseline (pretreatment with AEDs only).~   "
59880|NCT02783079|"~     This study looks at two different interventions used for the treatment of insomnia in~     survivors of breast, colon, lung, prostate and gynecologic cancer.~   "
59881|NCT02783066|"~     Diabetic foot ulceration (DFU) is a common and largely preventable complication of diabetes.~     While most of these ulcers can be treated successfully, some will persist and become~     infected. Ultimately, nearly one fifth of patients with infected lower-extremity diabetic~     ulcers will require amputation of the affected limb, resulting in staggering costs for both~     the patient and the healthcare system. Prevention by identifying people at higher risk is key~     for better clinical management of such patients. It is not uncommon for patients suffering~     from diabetes to have concomitant lower extremity edema or venous insufficiency and they~     subsequently may benefit from graduated compression. However, because of the common~     association of peripheral arterial disease (PAD) in patients with diabetes, most clinicians~     are reluctant to apply compressive dressings in fear of exacerbating the symptoms of PAD and~     possibility of gangrene.~      A novel low voltage, battery powered medical device, PulseFlow DF® (The Diabetic Boot~     Company, Ltd. UK) has endeavored to assist in the treatment of Diabetic Foot Ulcers. The~     device provides hybrid functionality i.e. mobile air bladder pump at plantar arch and~     offloading boot. The air bladder inflates to 160 mmHg for approx. 1 second then deflates back~     to atmospheric pressure, allowing the plantar vessels sufficient time to refill. The~     offloading boot design holds the foot and lower leg in a position that reduces shear and~     friction forces and provides a reduction in plantar pressure.~      The PulseFlow DF is designed to record how many hours of blood pumping it has delivered. This~     data will be downloaded at each clinic visit. The boot cannot pump blood around the~     participant's foot unless fitted correctly and the battery is charged up overnight.~      The purpose of this study is to conduct an interventional study study with N=15 diabetic~     subjects with active foot ulcers to assess whether PulseFlow foot compression device can help~     improve lower extremity perfusion, whilst improving balance and spatio-temporal parameters of~     gait.~      The key goals of the proposed project are to test whether a specially designed compression~     device can improve lower extremity perfusion, whilst also simultaneously improving the~     balance and walking performance. Investigators envision the use of this specially designed~     offloading device with compression capability will help reduce the incidence of diabetic foot~     ulcers in high-risk diabetic patients. In addition, investigators assumed the proposed device~     might enhance daily physical activity as well as walking performance. Investigators will~     conduct a prospective clinical study to validate these hypotheses. Potential changes in~     walking and spontaneous daily physical activities will be assessed using validated~     technologies that include walking analyzer system, balance assessment using body worn~     sensors, and computerized pressure insoles.~   "
59882|NCT02783053|"~     Metformin is known to increase 18F-FDG uptake in subjects using metformin in retrospective~     trials.~      In this study the researchers aim to investigate the influence of metformin (500 mg 1/day) on~     temperature in the colon, glucose uptake in the colon and energy expenditure in healthy lean~     (BMI < 24kg/m2) or obese subjects (BMI>28kg/m2). The investigators will measure 18F-FDG~     uptake in the colon, temperature in the colon, insulin sensitivity and energy expenditure~     before after using metformin.~   "
59883|NCT02783040|"~     To assess the influence of multiple doses of BI 425809 on single dose pharmacokinetics of~     midazolam (CYP3A4 probe drug), warfarin (CYP2C9 probe drug), omeprazole (CYP2C19 probe drug)~     and digoxin (P-gp probe drug)~   "
59884|NCT02783027|"~     The overarching goal of this proposal is to address the MedEvac foundation priority of~     educational techniques and technologies and improve Helicopter Emergency Medical Services~     (HEMS) safety by determining if overall sleep quality and intra-shift fatigue of HEMS~     clinicians can be improved with real-time assessment and intervention.~      Aim 1: To determine the short-term impact of an enhanced SleepTrackTXT intervention on HEMS~     clinician fatigue reported in real-time during and at the end of shift work.~      Aim 2: To determine the long-term impact of the SleepTrackTXT intervention on sleep quality~     and sleep health indicators including hours of sleep and recovery between shift work.~   "
59885|NCT02783014|"~     This study investigates the central mechanisms of Overactive Bladder (OAB) in Patients with~     Parkinson's Disease (PD).~      The plan is to enroll 10 adults with Parkinson's disease and Overactive bladder (PD + OAB)~     and 10 adults with Parkinson's disease only (PD). Both groups will undergo fMRI (functional~     MRI).~   "
59890|NCT02782936|"~     Background: The gas mask is used to protect military and non-military subjects exposed to~     respiratory hazards (CBRN agents). The aim of the study was to evaluate the impact of the gas~     mask on respiratory patterns and indexes of the respiratory effort. Methods: We are~     completing our study with 14 healthy subjects to evaluate breathing patterns, index of~     respiratory efforts and blood gases. Seven conditions have been tested in a randomized order:~     at rest, during effort (on a tread mill, standardized at 7 METs for all subjects) and during~     induced hypoxemia with and without a mask (C4, Airboss Defence, Bromont, Canada). Airway~     pressure, inspiratory and expiratory flows were measured. An esophageal catheter was~     introduced at the beginning of the study to measure esophageal pressure (Peso) and calculate~     indexes of respiratory effort (PTPeso, WOB). SpO2 was continuously measured and capillary~     blood bases were drawn at the end of each condition. Each condition lasted 10 minutes, data~     of the last 2 minutes at a steady state were considered for analyses. Results: The~     preliminary analyses based on 10 subjects are presented here. Comparing the wearing of the~     gas mask and without, most of the respiratory index increased in the tested conditions (at~     rest, during induced hypoxemia and during effort). At rest, in 8 out of 10 healthy subject~     the indexes of effort were higher with the gas mask, a statistical trend was observed with~     the WOB (0.22±0.13 vs. 0.28±0.10 J/cycle; p = 0.059), the PTPes (101±35 vs. 122±47 cmH2O*s;~     p=0.21) and SwingPeso (4.4±2.0 vs. 5.3±2.0 cmH2O; p=0.13). During the effort, the respiratory~     index increased (WOB 4.0±2.6 vs. 5.6±3.2; p=0.10; PTPeso 406±211 vs. 606±65; p=0.04;~     SwingPeso 14.8±8.1 vs. 21.8±9.0; p=0.13). There was no difference for the breathing pattern~     and arterial blood gases data with and without mask. Data for induced hypoxemia are under~     analysis. We measured on bench the inspiratory and expiratory resistances of the tested gas~     mask (C4: inspiratory resistances = 3.2 cmH2O at 1 L/sec; expiratory resistances = 0.9 cmH2O~     at 1 L/sec). This may explain in part the increased work of breathing with masks.~     Conclusions: This study demonstrated an increase of the indexes of respiratory effort during~     an exercise with the gas mask. This study is the first to directly assess the indexes of~     efforts with esophageal pressure in this situation. Our results and method may be used as a~     reference for evaluating tolerance with different designs of gas masks.~   "
59891|NCT02782923|"~     This is a single-center, prospective controlled simulation study designed comparing and~     evaluating the driving performance of subjects who have had cervical spine surgery and the~     use of a validated driving simulator. To date, there haven't been evidence-based~     recommendations to determine a patient's fitness to drive in the peri-operative or~     postoperative state. The objective of this study is to delineate the effect cervical spine~     procedures have on driving performance in the peri-operative time period. The study will take~     place at New York University Langone Medical Center - Hospital for Joint Diseases which will~     include the surgeries. The follow up visits will be at the NYU Center for Musculoskeletal~     Care.~   "
59892|NCT02782910|"~     Bipolar disorders are severe chronic disorders, marked by recurrent episodes of depression~     and (hypo)mania. The disorder usually emerges in early adulthood and tends to have a highly~     unpredictable course. Prevention of these episodes is essential, as they are associated with~     marked impairment in social and occupational functioning. The investigators propose to~     conduct a randomized, multi-center, observer-blind, parallel group controlled trial with an~     78 week (18 month) intervention phase to test the hypothesis that continuous ambulatory~     real-time monitoring of early warning signs for new depressive or (hypo)manic episodes by~     smartphone based, innovative technology (e.g. GPS, acceleration sensor), including individual~     threshold- based early intervention for these early warning signs, will prolong time to a new~     mood episode and reduce hospitalizations (intervention group). In the control group~     ambulatory monitoring of early warning signs for emerging depressive or (hypo)manic episodes~     will occur in an identical manner, but the results will not be transmitted to the treating~     psychiatrist. All patients in this trial, irrespective of their group assignment, will~     receive guideline-based, state-of-the-art maintenance treatment.~   "
59893|NCT02782897|"~     This pilot study aims to investigate whether intravenous immunoglobulin is safe and effective~     in alleviating perihematomal edema and neurologic deficits in patients with intracranial~     hemorrhage.~   "
59894|NCT02782884|"~     Patients undergoing approximately 10 common outpatient general surgical operations will be~     given a narcotic prescription for a specified number of pills.~      Inpatients who are about to be discharged after surgery or trauma will be given narcotic~     prescriptions for a specified number of pills. Patients will be given a patient report form~     which they will use to record the number of pills they take each day and their daily pain~     score on a scale of 0-10.~   "
59895|NCT02782871|"~     Following major head and neck surgery it may be necessary to keep patients intubated and~     ventilated for at least 12 hours to allow the swelling associated with the operation to~     subside. Therefore patients (participants) are transferred to the intensive care unit~     anaesthetised, in-tubated and ventilated. Current practice is that patients are manually~     ventilated, by hand, during transfer from the operating theatre to the intensive care unit.~   "
59896|NCT02782858|"~     The humanised IgG4 monoclonal antibody GNbAC1 targets the envelope protein (Env) of the human~     endogenous multiple sclerosis-associated retrovirus (HERV-W MSRV), which may play a critical~     role in multiple sclerosis (MS).~      This study evaluates the effect on MRI lesions parameters, the safety and pharmacokinetics of~     GNbAC1 in patients with relapsing remitting multiple sclerosis.~   "
59897|NCT02782845|"~     This study will assess the prophylactic effect of pegfilgrastim (Neulastim) on febrile and/or~     Grade IV neutropenia in participants receiving chemotherapy (CT) or immunochemotherapy (ICT)~     as first or second line treatment for NHL. Pegfilgrastim will be administered at a fixed dose~     of 6 milligrams (mg) subcutaneously 24 hours after the last dose of CT or ICT in each~     treatment cycle.~   "
59898|NCT02782832|"~     This study analyse the need for neuromuscular blockade in consecutive routine laparoscopic~     procedures without standard use of neuromuscular blockade in an ambulatory laparoscopic~     surgery setting and analyse specific reasons for using neuromuscular blockade in individual~     patients. Furthermore, the study report the analgesic use in postoperative care unit and the~     discharge rate.~   "
59899|NCT02782819|"~     Fluid resuscitation is the most effective treatment of shock. Isotonic crystalloid solution~     is the current recommended initial fluid resuscitation. However, this kind of fluid has high~     volume of distribution and may require large volume administration before achieve therapeutic~     goal of shock reversal. There are rising concern about the delay in shock reversal and~     adverse consequences of large amount volume of fluid therapy. Colloid fluid have been used as~     the alternate fluid resuscitation, aiming to limit the volume of fluid resuscitation and~     promote shock reversal. Whether colloid infusion can improve shock reversal rate and decrease~     complication associated with fluid resuscitation, had inconclusive information.~   "
59900|NCT02782793|"~     A prospective outcomes study in patients referred for endoscopic mucosal resection of complex~     colon polyps.~   "
59928|NCT02782429|"~     The purpose of this study is to analyze the Ketamine with its anti-inflammatory profile would~     be able to prevent cognitive disorders in the postoperative period of cardiac surgery, since~     these disorders contribute to an impact on morbidity / mortality in this population.~   "
59929|NCT02782416|"~     Study the prevalence of LTBI in patients who are waiting renal transplant and monitor the~     incidence of active TB~   "
59901|NCT02782780|"~     Sleep disturbance is a common complaint of Veterans with Gulf War Illness (GWI). Because~     there is clinical evidence that sleep quality influences pain, fatigue, mood, cognition, and~     daily functioning, this study will investigate whether a type of behavioral sleep treatment~     called Cognitive Behavioral Therapy for Insomnia (CBTi) can help Gulf War Veterans with GWI.~     CBTi is a multicomponent treatment where patients learn about sleep and factors affecting~     sleep as well as how to alter habits that may impair or even prevent sleep. The investigators~     hypothesize that helping Gulf War Veterans learn how to achieve better sleep with CBTi may~     also help to alleviate their other non-sleep symptoms of GWI.~   "
59902|NCT02782767|"~     Comparison of efficacy in management of pain in abdominal surgery between epidural versus~     wound infusion catheter {catheter placed within the incision site}~   "
59903|NCT02782754|"~     The purpose of this study is to evaluate the outcome of intracranial germinoma treated with~     chemotherapy plus reduced radiotherapy.~   "
59904|NCT02782741|"~     Primary Objective:~      To determine the effect of neoGAA (GZ402666) treatment on respiratory muscle strength~     measured by percent predicted forced vital capacity (% FVC) in the upright position, as~     compared to alglucosidase alfa.~      Secondary Objective:~      To determine the safety and effect of neoGAA treatment on functional endurance (6-minute walk~     test (6MWT), inspiratory muscle strength (maximum inspiratory pressure (MIP)), expiratory~     muscle strength (maximum expiratory pressure (MEP)), lower extremity muscle strength~     (hand-held dynamometry (HHD)), motor function (Quick Motor Function Test (QMFT)), and~     health-related quality of life (SF-12).~   "
59905|NCT02782728|"~     This pilot study will evaluate a computer-based intervention titled Trauma-informed~     Personalized Scripts (TIPS). The goal of this intervention is to improve patient-provider~     communication about sensitive topics such as intimate partner violence (IPV) and reproductive~     coercion (RC). The main aim of this study is to pilot test TIPS in family planning clinics~     using a randomized study design to compare the basic version of TIPS (a computer-based~     assessment with provider scripts only) to an enhanced TIPS containing a tailored brief~     intervention for patients along with provider scripts. The investigators plan to recruit 240~     female patients ages 16-29 for this study.~   "
59906|NCT02782715|"~     The specific aims of this study are:~        1. To determine the safety and feasibility of treating patients with a combination of MRI~          guided stereotactic body radiation therapy and microwave ablation.~        2. To assess short and long-term toxicity rates of patients treated with a combined~          modality approach.~        3. To assess local control, survival, and pathologic response to treatment~   "
59907|NCT02782702|"~     Hailey Hailey and Darier disease are rare genetic dermatoses. Mutations of 2 genes (ATP2C1 or~     ATP2A2 respectively) are responsible for the diseases. These genes have a key role in calcium~     pump; their defect create abnormal link between keratinocytes' desmosomes and induce skin~     lesions. Clinically, patients present with inflammatory lesions located in the folds. Quality~     of life is impaired because of pain, pruritus and tendency to infections. Lesions are~     permanent but acute exacerbations occur in hot seasons because of increased sweating. Usual~     therapies are often not effective (local treatment, laser, phototherapy). Because sweating is~     a well established inducing or aggravating factor, botulism toxin could be an effective~     treatment for these diseases.~      Botulism toxin is already used in clinical practice and acts via a decreased sweet secretion.~     Improvement of skin lesions in Hailey-Hailey or Darier diseases has been previously reported~     in a few cases but there is no study properly evaluating the benefit of such treatment.~      The aim of the project is to study the improvement of quality of life for patients suffering~     from Hailey-Hailey or Darier diseases after a injections of botulism toxin in large skin~     folds. The principal objective is to estimate the distribution of the variation of quality of~     life at M1 vs. baseline.~   "
59908|NCT02782689|"~     The primary objective of this study is to demonstrate the non-inferiority of the 2-layer~     compression system Kit Biflex® with regard of the 4-layer compression system PROFORE® in the~     treatment of venous leg ulcers in terms of complete healing at 16 weeks.~   "
59909|NCT02782676|"~     Prospective, multicenter, paired-eye, randomized, masked, clinical trial of the~     bacterially-derived Healon5 OVD versus the currently available Healon5 OVD control.~   "
59910|NCT02782663|"~     This is a open-label extension (OLE) study designed to evaluate the long-term efficacy,~     safety, and tolerability of ABT-494.~   "
59911|NCT02782650|"~     This study is part of the PreCo study, evaluating Dutch care in (imminent) extreme preterm~     birth including current and preferred counseling, barriers and facilitators for preferred~     counseling from both obstetricians and neonatologists, as well as parents' views on this.~      Since 2010, intensive care can be offered in the Netherlands at 24+0 weeks gestation (with~     parental consent) but as some international guidelines, the Dutch guideline lacks detailed~     recommendations on organization, content and preferred decision-making of the counseling.~   "
59912|NCT02782637|"~     This study is part of the PreCo study, evaluating Dutch care in (imminent) extreme preterm~     birth including current and preferred counseling, barriers and facilitators for preferred~     counseling from both obstetricians and neonatologists, as well as parents' views on this.~      Since 2010, intensive care can be offered in the Netherlands at 24+0 weeks gestation (with~     parental consent) but as some international guidelines, the Dutch guideline lacks detailed~     recommendations on organization, content and preferred decision-making of the counselling.~   "
59913|NCT02782624|"~     To investigate the influence of different dosage regimen (5 mg twice daily versus 10 mg once~     daily) on the steady state pharmacokinetics and pharmacodynamics of BI 10773 administered~     orally~   "
59930|NCT02782403|"~     Objectives:~      Primary:~      Chronic Phase Cohort: To assess the rate of major cytogenetic response (MCyR) of an~     alternating schedule of axitinib and bosutinib in patients with chronic myeloid leukemia,~     chronic phase (CML-CP) after failure of/intolerance to >/= 3 tyrosine kinase inhibitors~     (TKIs) using standard response criteria.~      Advanced Phase Cohort - Phase I Portion: To determine the recommended phase II doses (RPTDs)~     of axitinib and bosutinib in combination in patients with CML in accelerated phase (CML-AP)~     or blast phase (CML-BP). (AP patients must have received >1 prior TKI).~      Advanced Phase Cohort - Phase II Portion: To evaluate the rate of major hematologic response~     (MaHR) of combined treatment with axitinib and bosutinib in patients with CML-AP or CML-BP~     using standard response criteria. (AP patients must have received >1 prior TKI).~   "
59914|NCT02782611|"~     Over the past several decades, a new science of subjective well-being has produced insights~     into the factors that make people happy—from cultivating strong relationships to pursuing the~     right goals. Drawing on these empirical findings, the investigators created a comprehensive~     12-week intervention program, ENHANCE: Enduring Happiness and Continued Self-Enhancement. The~     investigators multimodal program is designed to teach people essential skills in order to~     produce sustainable changes in behavior and, as a result, long-lasting increases in~     happiness. To test the effectiveness of ENHANCE, the investigators designed a six-month~     randomized clinical trial. Participants will be assigned to an active treatment group or a~     waiting group control. They will complete baseline assessments, and follow-up assessment at~     three and six months after the start of the intervention. These assessments will contain~     measures of subjective well-being and objective measures of health, as well as a variety of~     psychological mediators (e.g., psychological needs) and moderators (e.g. personality). The~     investigators will thus be able to explore not only whether ENHANCE works to improve~     well-being, but also why and how ENHANCE works.~   "
59915|NCT02782598|"~     The purpose of this study is to evaluate the application of Negative AV Hysteresis (NAVH) to~     improve electrical synchrony in MultiPoint Pacing (MPP) Cardiac Resynchronization Therapy~     (CRT) patients.~   "
59916|NCT02782585|"~     Manual therapy (MT) techniques applied over cervical region have over both local (neck) and~     distant regions (elbow) in both asymptomatic and symptomatic populations. Neurophysiological~     mechanisms are hypothesized to explain the underlying effects, with effects originating from~     peripheral mechanisms, spinal cord and supraspinal mechanisms.~      There is also an increasing interest in the study of the role of psychological variables in~     the treatment success in neck pain. Psychological variables, like anxiety catastrophizing or~     kinesiophobia are related to poor prognosis in the development of pain outcomes and~     disability in neck pain, being the Fear-Avoidance Model of pain one of the most tested models~     in this field.~   "
59917|NCT02782572|"~     This project deals with exercise in acute heart failure in three different groups~     (conventional medical treatment; exercise with non-invasive ventilation and exercise with~     placebo of non-invasive ventilation).~   "
59918|NCT02782559|"~     Randomized controlled trial to assess efficacy of Sildenafil in addition to expectant~     management for the treatment of preterm preeclampsia~   "
59919|NCT02782546|"~     This is a standard phase 2 study powered to demonstrate improvement in the 100 day leukemia~     free survival to 30% from <10% expected with the use of reduced intensity haplo-HCT in this~     extremely high-risk patient cohort (based on the institutional experience using~     non-myeloablative / reduced intensity conditioning in a similar patient cohort).~      A formal safety evaluation will be done after every 6th patient enrolled and the trial will~     be stopped if noted to have unusually higher engraftment failure (acute GVHD rates (>60% any~     grades or >30% grade III/IV or ≥ 50% severe cGVHD) or engraftment failure rates (≥15%).~   "
59920|NCT02782533|"~     Study of Deep Brain Stimulation of the Third ventricle in Cluster Headache and Obesity~     treatment.~   "
59921|NCT02782520|"~     This study is a phase III, randomized, controled, parallel groups, single blinded, clinical~     trial that aims at comparing the improvement of right ventricular function after~     administration of a hypertonic solution versus Ringer Lactate following cardiac surgery.~      Adults patients admitted to Grenoble University Hospital for elective cardiac surgery under~     cardiopulmonary bypass, in sinus rhythm and with Swan Ganz monitoring will be included.~      Patients needing fluid expansion in the first three hours after surgery will be randomized in~     two groups : one receiving Ringer Lactate (10 mL/kg), the other receiving hypertonic saline~     solution (3 mL/kg).~      Right ventricular function measured with Swan Ganz catheter, 30 minutes after fluid expansion~     will be the primary outcome.~   "
59922|NCT02782507|"~     The study is a pilot study of Cognitive therapy for people with psychosis who have~     distressing visual hallucinations. The aim is to evaluate whether this is an acceptable,~     feasible and effective treatment. This is a pilot study and there is no randomisation to~     either CBT or treatment as usual (TAU). If a participant is allocated to the cognitive~     therapy plus TAU condition then the participant will meet with a therapist on initially a~     weekly basis and receive up to 8 sessions of CBT over a 2 month period. The participant will~     also have regular assessments conducted by a researcher who is independent to the treatment~     group. It is predicted that those people receiving CBT will improve on measures of symptoms,~     and particularly for measures of visual hallucinations.~   "
59923|NCT02782494|"~     In patients receiving long term dialysis, using new generation of QuantiFERON-TB Gold Plus~     can have less result variability in inter-experiment and serial follow up in comparing with~     QuantiFERON-TB Gold In-tube.~   "
59924|NCT02782481|"~     This is a multicenter, randomized, double blind, placebo controlled parallel group clinical~     study. Following a screening period of up to 28 days, eligible subjects will be randomized to~     receive adjunct treatment to oral LD/DDI (Dopa Decarboxylase Inhibitor) with continuous~     subcutaneous infusion of ND0612 or matching placebo for 16 weeks.~   "
59925|NCT02782468|"~     The purpose of this study is to evaluate the safety and tolerability of pevonedistat~     administered as a single agent and in combination with azacitidine in adult east Asian~     participants with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS).~   "
59926|NCT02782455|"~     Haemorrhoids are vascular cushions in the anal canal that help in the control of stool. When~     inflamed they become pathological and may present with protrusion and bleeding. A randomized,~     triple blind , controlled study will be conducted to compare the efficacy of calcium~     dobesilate against flavanoids in the management of early haemorrhoidal disease.~   "
59927|NCT02782442|"~     The purpose of this study is to use remote methods and scalable interactive neurotechnology~     to generate important data on the potential for remote targeted cognitive treatment in people~     with schizophrenia. The investigators will perform a double-blind randomized control trial in~     120 participants with schizophrenia, comparing: 1) An evidence-based structured program of 40~     hours of on-line auditory and social cognitive training (exercises over 12 weeks (-3.5 hours~     per week), delivered with an innovative digital application which provides users with a~     motivation coach to set personalized goals and with secure social networking for peer~     support, Personalized Real-time Intervention for Motivational Enhancement (PRIME) ; vs.2) A~     control condition of free-choice on-line cognitive exercises, encouraged at 3.5 hours per~     week over 12 weeks, delivered with a standard commercial goal-setting app, Daily Goals.~   "
59931|NCT02782390|"~     Atypical carious cavities could be defined as carious lesions in more than 2 surfaces of the~     same tooth. Dental practitioners have shown difficulties related to material's maintenance in~     such type of cavities and therefore, several treatment options have been used. However, most~     of them have shown a great failure percentage. A randomized clinical trial will be developed~     with the objective of assessing the Hall technique in comparison with the composite resin~     incremental technique in 464 primary molars' atypical carious lesions of children between 4~     and 9 years old. Initially, two previously calibrated examiners will perform caries diagnosis~     by means of visual assessment and intraoral examination. Selected teeth will be randomly~     allocated into two groups. Teeth in the first group will be submitted to prefabricated~     stainless steel crowns treatment (Hall technique); and the other, to composite resin~     incremental technique, which will be always placed under rubber dam isolation. Lesions'~     clinical and radiographic follow-up will be conducted after 6 and 12 months.~      Treatment's efficacy will be assessed by means of four main outcomes:~        1. Longevity, marginal adaptation, possible modification in patients' vertical dimension,~          and caries lesion progression;~        2. Patient-focused criteria (satisfaction, discomfort and quality of life impact);~        3. cost-efficacy; and~        4. Treatment-related parents', children' and operators' perception.~      Other variables could be further analysed as secondary outcomes, such as techniques~     performing time among operators, impact of the socio-economic characteristics on~     restorations' longevity, and restorations' type impact on the antagonist tooth. Comparisons~     between groups will be addressed using the Kaplan-Meier survival test as well as Long-Rank~     test. Cox Regression will be used to enable the assessment of other variables' influence in~     the results. Significance value of 5% will be adopted for all analysis.~   "
59932|NCT02782377|"~     Anal Acoustic Reflectometry (AAR) is a reliable and reproducible technique that has been~     studied in our department over the last 6 years. Sound waves pass into a balloon placed in~     the anal canal and are used to measure the cross-sectional area. By gradually increasing and~     decreasing the pressure in the balloon the investigators can measure the pressure at which~     the cross-sectional area starts to increase and decrease, and the anal canal starts to open~     and close. This assessment mimics the natural opening and closing of the anal canal and the~     effect of squeezing the muscles.~      The gold standard investigation of the anal sphincter muscles has been manometry which~     measures anal canal pressure at rest and during squeeze. However, it has limitations. In~     previous studies AAR has shown promise in the assessment of faecal incontinence and, that~     unlike manometry, it has been able to distinguish between different types of incontinence.~      The Recto-anal Inhibitory Reflex (RAIR) is a normal response when the rectum fills with~     faeces, fluid or air, whereby there is a change in the pressures within the anal canal to~     determine the type of contents. This can be absent or altered in patients who have difficulty~     in opening their bowels. The RAIR is currently measured by anal manometry using a 4.9mm~     catheter, resulting in an anal canal which is already partially opened prior to the~     measurement, and potentially distorted.~      AAR is considered a catheter free technique as the balloon has a cross-sectional area of only~     0.4mm2 when collapsed. The investigators propose to measure the RAIR using a 1.7mm diameter~     catheter alongside the AAR balloon to determine the effect that its placement has on the~     recorded parameters of AAR. This aims to improve our understanding of the opening and closing~     of the anal canal in response to distension of the rectum.~   "
59933|NCT02782364|"~     Anal Acoustic Reflectometry (AAR) is a technique that has been studied in our department over~     the last 6 years. Sound waves pass into a balloon placed in the anal canal and are used to~     measure the cross-sectional area. By gradually increasing and decreasing the pressure in the~     balloon the investigators can measure the pressure at which the cross-sectional area starts~     to increase and decrease, and the anal canal starts to open and close. This assessment mimics~     the natural opening and closing of the anal canal and the effect of squeezing the muscles.~      The gold standard investigation of the anal sphincter muscles has been manometry which~     measures anal canal pressure at rest and during squeeze. However, it has limitations. Despite~     the two measurements being within the normal range, some patients can have significant faecal~     incontinence. This has prompted clinicians to search for a better investigation to guide the~     management of this condition.~      AAR is a reproducible and repeatable technique that has been used as a research technique in~     the assessment of faecal incontinence. It has been shown to correlate with symptom severity~     and, unlike manometry, is able to distinguish between different symptomatic subgroups with~     faceal incontinence. In our studies so far the investigators have increased the bag inflation~     pressure a step at a time which means that each study takes about 20 minutes to perform. The~     limitation of this method is that during the measurement of squeeze pressure the sphincter~     muscle is subject to fatigue. A recent study using the acoustic technique in the urethra has~     demonstrated a faster method of recording measurements over an 8 minute period. The~     investigators propose to study the fatiguability effects of this faster technique and~     validate the method against the existing step-wise technique and standard anal manometry.~      Patients will be randomised into two groups:~        1. Stepwise then fast-fill~        2. Fast-fill then stepwise~   "
59934|NCT02782351|"~     The present study evaluates the safety and efficacy of humanized Chimeric antigen receptor T~     cells (CAR-T) in treating recurrent or refractory B cell malignancy targeting CD19 with a~     humanized scFv. All participants will receive autologous chimeric antigen receptor engineered~     T cells.~   "
59935|NCT02782338|"~     A prospective study intended to examine the effect of topical Voltaren-Ophtha 0.1% eye drops~     after cataract surgery on INR levels (international normalized ratio) in patients taking~     warfarin.~   "
59936|NCT02782325|"~     Antibiotic dependent pouchitis (ADP) is predestined to benefit from FMT, since bacterial~     dysbiosis, which can only be controlled with antibiotics, appears to be the major driver of~     the clinical symptoms. This is a proof of concept randomized placebo controlled trial, in~     which 50% of the patients will receive FMT and 50% will receive a placebo FMT. Additionally~     the trial offers an open label extension period.~   "
59937|NCT02782312|"~     The objective of this study is to assess the efficacy and safety of Salmeterol-Fluticasone~     （ICS and LABA）combined inhaled therapy for non-cystic fibrosis（non-CF）bronchiectasis patients~     with chronic airflow obstruction. Moreover, subgroup analysis is performed to explore which~     populations of bronchiectasis patients this treatment is suitable for.~   "
59938|NCT02782299|"~     This is a study to investigate the use of a Decision Aid for shared decision making in older~     adults with distal radius fractures. The goal is to improve patient decisions making, and~     improve patient knowledge through the use of a validated decision aid.~   "
59939|NCT02782286|"~     The study is prospective, double blinded, randomised controlled and has the purpose to~     compare the analgesic effects of ketorolac or morphine intravenous in low back pain.~   "
59940|NCT02782273|"~     The study is prospective, double blinded, randomised controlled and has the purpose to~     compare the analgesic effects of ketorolac or morphine intravenous in renal colic.~   "
59941|NCT02782260|"~     Subjects with pterygium and associated dry eye symptoms (DES) are randomized into an active~     cohort (receiving ocular administration of Dipyridamole) or placebo cohort (ocular~     administration of vehicle). Monthly follow up is conducted for 12 months. Testing conducted~     at follow up will assess dry eye / pterygium symptoms and endpoints and review the efficacy~     of the intervention.~   "
59942|NCT02782247|"~     Chronic viral hepatitis often leads to liver scarring - cirrhosis. If the virus is eradicated~     from the liver, the liver scarring and liver function often recovers. In some patients the~     damage is too severe and recovery does not take place. It is not yet known which patients~     have liver disease that is too advanced to benefit from therapy nor is it known how fast the~     recovery occurs.~      Non-intrusive dynamic liver testing (DLT) may allow us to predict the functionality of the~     liver post treatment and may guide us in treatment choices - for example patients who are~     predicted not to recover may be prioritised for transplantation. Indocyanine green (ICG) is a~     dye solely excreted by the liver into bile and used to measure its dynamic function.~     Transient elastography is similar to ultrasound and measures the degree of fibrosis within~     the liver.~      The investigators hypothesise that the use of non-intrusive dynamic liver testing~     pre-treatment, will allow us to delineate patients before therapy who will have functional~     liver recovery following viral eradication.~      The investigators hypothesise that monitoring changes in liver fibrosis and liver function in~     patients with historical viral clearance will allow an assessment of the likely speed of~     recovery of liver fibrosis and function - for example if all patients 5 years after treatment~     for viral hepatitis induced cirrhosis have 'normal' fibrosis and liver function scores the~     investigators will be able to conclude that recovery is complete within 5 years.~      The investigators will perform a study pre and post-treatment assessing liver function using~     non-intrusive dynamic liver testing in addition to currently-used 'liver function' scoring~     systems, in a multivariate analysis, to determine whether or not the investigators can~     identify patients who are will have functional liver recovery post therapy.~   "
59944|NCT02782221|"~     Growth hormone (GH) induces fat metabolism. The mechanisms underlying the fat metabolizing~     effects of GH remain elusive. However, it is known that insulin suppresses fat metabolism,~     and GH inhibits the expression of certain insulin-dependent signaling proteins. We therefore~     hypothesize that the fat metabolizing effects of GH depend on abrogation of insulin-dependent~     signaling pathways.~      In order to investigate the fat metabolizing effects of GH, we'll analyze consecutive adipose~     tissue biopsies taken after GH exposure and GH blocking, respectively.~      Knowledge of the effects of growth hormone and fat metabolism can in shot-sight as well as in~     long-sight have great importance for the understanding of growth disorders from overweight~     and type 2 diabetes to malnutrition and eating disorders.~   "
59945|NCT02782208|"~     Growth hormone (GH) is essential for longitudinal bone growth and somatic development. These~     protein anabolic effects require sufficient nutritional supply. During fasting and caloric~     restriction GH predominantly promotes fat metabolism.~      GH counteracts the effect of insulin in many tissues, of which insulin-stimulated glucose~     uptake in skeletal muscle has been most extensively studied. Substrate competition between~     elevated free fatty acids and glucose is suggested as a mechanism, and this hypothesis can be~     tested mechanistically by means of acipimox, which is a nicotinic acid that suppresses the~     fat metabolizing effects of GH.~      The hypothesis is, that the suppressive effect of GH on insulin-stimulated glucose uptake in~     skeletal muscle is obviated by acipimox-induced inhibition of fat metabolism.~      In order to investigate this, eight adult hypopituitary patients with documented~     GH-deficiency will be studied in the presence and absence of GH and acipimox, respectively,~     and biopsies from skeletal muscle and subcutaneous adipose tissue will be analyzed.~      Knowledge of the effects of growth hormone and fat metabolism can in shot-sight as well as in~     long-sight have great importance for the understanding of growth disorders from overweight~     and type 2 diabetes to malnutrition and eating disorders.~   "
59946|NCT02782195|"~     Eight adolescent and young adult subjects with type 1 diabetes, age 16−24 years, will be~     recruited for this study on the basis of informed consent. Participants will be invited to~     attend the Wellcome Trust Clinical Research Facility at Addenbrooke's Hospital, Cambridge, on~     two occasions. On each occasion participants will arrive at the unit at 9am having controlled~     their diabetes with short acting insulin for 24 hours and they will remain in the unit until~     8am the next morning. During the day, between 9am and 6pm participants will remain fasting~     and their blood glucose levels will be controlled by intravenous insulin, the dose being~     determined by 15−30 minute blood glucose estimations. At 1800hr on visit 1 the subjects will~     be asked to ingest an evening meal enriched by a cold isotope glucose tracer (non~     radioactive). The variable insulin infusion will be adjusted to allow for the meal in order~     to achieve good glycaemic control after the meal until 0200hr. From then until 0800hr in the~     morning the study team will again adjust the infusion rates to maintain normal glycemia until~     the participants are ready to go home on their normal insulin regimen. On the second visit~     the protocol will be identical until 1800hr when instead of giving the meal variable amounts~     of glucose will be infused to ensure the glucose levels are identical to those observed on~     visit 1. After 0200hr the study will be effectively finished but the study team will continue~     to vary the insulin infusion to keep blood glucose levels normal until the subjects can go~     home on their normal insulin regime at 8am.~      In order to achieve sufficient information to make all the calculations needed other cold~     isotope glucose tracers will be infused during the study period. These safe non radioactive~     isotope tracers will enable us to assess glucose being produced by the body, its distribution~     and utilization. Throughout both study periods the subjects will be monitored very closely by~     a Clinical Research Fellow, assisted by a Research Nurse, in order to avoid any risk of low~     blood glucose levels.~   "
59947|NCT02782182|"~     The purpose of this study is to see whether it is possible to give 8 doses of a combination~     of chemotherapy called FOLFIRINOX before surgery in subjects whose pancreas cancer can be~     removed with surgery.~   "
59948|NCT02782169|"~     Medical abortion has been associated with significant pain. The objective of this trial is to~     determine whether one dose of pregabalin 300 mg, given during medical abortion in addition to~     the standard of care analgesics, will decrease experienced pain. Investigators will perform a~     randomized, double-blinded, placebo-controlled trial. Participant pain levels and side~     effects will be assessed at multiple time points, along with a measure of satisfaction.~   "
59949|NCT02782156|"~     In ear, nose, throat (ENT) and jaw surgery departments, up to 60% of patients suffer from~     alcohol dependence (Allen et al., 2009), and may develop an alcohol withdrawal syndrome (AWS)~     when undergoing sur-gery. Caring for these patients creates a major challenge for all persons~     involved: Health care staff is not only challenged by the primary illness but also by~     increased risk of life-threatening complications (infection, bleeding, cardiopulmonary~     dysfunction, impaired wound healing, re-operation), higher mortality rate, and longer~     duration of hospitalization due to preoperative alcohol use and the development of an AWS~     (Delgado-Rodriguez, Gomez-Ortega, Mariscal-Ortiz, Palma-Perez, & Sillero-Arenas, 2003; Eyer~     et al., 2011; Foy, Kay, & Taylor, 1997; Genther & Gourin, 2012; Kuo et al., 2008; Mayo-Smith~     et al., 2004; McCusker, Cole, Abrahamowicz, Primeau, & Belzile, 2002; Neyman, Gourin, &~     Terris, 2005; O'Brien et al., 2007). Moreover, nearly five percent of all patients with an~     AWS develop an alcohol withdrawal delirium (AWD) which, without any therapy, will end~     lethally in 15% of all cases. With adequate medical and other interventions lethality is~     about two percent (Diener, 2003; Wright, Myrick, Henderson, Peters, & Malcolm, 2006).~     Additionally, the occurrence of an AWS and / or AWD represents a threatening, time-intensive~     and complex situation for family members (Repper-DeLisi et al., 2008; Yu et al., 2012).~      Since 2011, in addition to patients undergoing short-term surgery, also patients with~     oncological diagnoses are hospitalized in the ENT and Jaw Surgery Department at the~     University Hospital Basel (USB). These patients are in need of prolonged surgical treatments~     and resulting longer periods of abstinence from food and drink, including alcohol and other~     substances, increase the risk of alcohol withdrawal. For instance, in the ENT and Jaw Surgery~     Department, in 2011, 74 out of 910 inpatients were at risk for or already experienced an AWD~     and 47 of them needed permanent supervision to guarantee their safety. Bridging the period of~     abstinence by drinking alcohol pre- and postoperatively is a suboptimal option for these~     patients due to the relatively long surgical treatment. This situation called for action:~     based on positive experiences within the dementia-delirium-programme of USB (Hasemann &~     Pretto, 2006), an evidence-based approach to screen for, detect and treat AWS and / or AWD in~     ENT and jaw surgery patients was developed and implemented (Hasemann, 2013). Now, this new~     approach needs to be evaluated.~   "
59950|NCT02782143|"~     The proposed Study validates the accuracy of the modified Confusion Assessment Method for the~     Emergency Department~   "
59951|NCT02782130|"~     This is a two-arm, randomized-controlled trial (RCT) that will test the acceptability,~     impact, and long-term sustainability of the Epic Allies intervention application (app), a~     theory-based mobile app that utilizes game mechanics and social networking features to~     improve engagement in care, antiretroviral therapy (ART) uptake, ART adherence, and viral~     suppression among HIV-positive young men who have sex with men (YMSM) and trans women who~     have sex with men. Subjects will be randomized to either the intervention branch of the Epic~     Allies app or the control branch of the app.~   "
59952|NCT02782104|"~     The purpose of this study is to assess the safety and tolerability of intranasal esketamine~     in participants with treatment-resistant depression (TRD).~   "
60047|NCT02780869|"~     The purpose of this prospective, randomized, controlled study is to evaluate the safety and~     efficacy of a new hemostatic device (HEMOBLAST™ Bellows) compared to a control device,~     absorbable gelatin sponge USP with thrombin.~   "
59953|NCT02782091|"~     Schizophrenia (SZ) is a chronic, severe disease resulting in a misperception of reality,~     major social withdrawal and cognitive disturbances. Executive dysfunctions are widely~     considered as primary determinants of functional outcome. However, classic neuropsychological~     executive function measures poorly represent patients' functional outcome and seem~     inappropriate to evaluate the real-world functional impact of the disease.~      In this perspective, Shallice and Burgess have developed for brain-damaged patients, the~     Multiple Errands Test (MET) allowing to assess planning, adaptation, problem solving and~     mental flexibility in real life settings, thus better capturing day-to-day abilities and~     including contextual (social, perceptive) influences. Setting the assessment outside the~     laboratory can help to identify subtle executive impairment not systematically expressed in~     standard care conditions and consequently improve the future care solutions. MET is based on~     the Supervisory Attentional System (SAS) model of executive functioning and attention control~     that specifies how thought and action schema become activated or suppressed for routine and~     non-routine circumstances .~      MET has been designed to measure real-world executive performance confronting the~     participants to unpredictable affordances and interpersonal interactions while planning and~     problem solving. Patients are asked to accomplish several tasks of variable complexity in an~     unknown commercial district. A number of rules must be respected and thus an action plan,~     strategy formulation, time and space management with very little assistance of the examiner~     are required.~      Most of the studies involving MET were conceived for patients with acquired brain damage.~     LeThiec offered an extensive protocol with the initial scoring system (in terms of~     inefficiencies, rule breaks, interpretation failures and task execution failures). Simplified~     versions of MET were also suggested to be more suitable in hospital settings. Only one study~     was done in SZ including a single patient, it is therefore difficult to draw conclusions~     about clinical utility in SZ. To date, no other studies investigated the suitability of MET~     in patients with psychosis, while executive impairment is well documented in this population~     The investigators hypothesized that the Multiple Errands Test (MET), an ecological assessment~     of executive function has a better ability to measure everyday adaptative functioning SZ,~     compared to conventional EF assessment methods.~      The objectives of this study are: (1) establish normative data and (2) study discriminant~     validity of this tool with a large panel of EF measures.~   "
59954|NCT02782078|"~     Clindamycin and rifampicin are authorized in osteoarticular infection treatment (IDSA~     guidelines) but some interaction is observed. The objective of this study is to evaluate and~     quantify rifampicin interaction on clindamycin~   "
59955|NCT02782065|"~     The purpose of this research will be to evaluate the reliability and validity of the HASS~     tool in a cohort of patients' ages 7 to18 years old against the gold standard of spirometry,~     and in ages 2 to 6 against spirometry, if possible, and the most similar validated tool, the~     PRAM.~   "
59956|NCT02782052|"~     Activity-related dyspnoea appears to be the earliest and the most frequent complaint for~     which patients with PAH seek medical attention. This symptom progresses relentlessly with~     time leading invariably to avoidance of activity with consequent skeletal muscle~     deconditioning and an impoverished quality of life. Unfortunately, effective management of~     this disabling symptom awaits a better understanding of its underlying physiology. Our team~     has recently showed that PAH patients may exhibit reduced expiratory flows at low lung~     volumes at spirometry (namely instantaneous forced expiratory flows measured after 50% and~     75% of the FVC has been exhaled [FEF50% and FEF75%] lower than predicted), despite a~     preserved forced expiratory volume in 1 second/forced vital capacity ratio (FEV1/FVC) .~     Several studies have shown that such a finding (small airway disease) could be common in~     certain PAH cohorts, have either related it to incidental descriptions of airway wall~     thickening with lymphocytic infiltration in PAH or proposed several other speculative~     explanatory mechanisms, either biological or mechanical. Whatever its cause, reduced~     expiratory flows at low lung volumes imply that the operating tidal volume (VT) range becomes~     closer than normally to residual volume (RV) mostly through an increase in RV (elevated~     residual volume/total lung capacity ratio, RV/TLC). The reduced difference between forced and~     tidal expiratory flows promotes dynamic lung hyperinflation [i.e., a progressive increase in~     end-expiratory lung volume (EELV)] under conditions of increased ventilatory demand. Dynamic~     lung hyperinflation (DH) is well known to have serious sensory consequences, i.e., increase~     in dyspnoea intensity, as clearly shown in patients with chronic obstructive pulmonary~     disease and chronic heart failure. The aim of this study is to evaluate whether~     administration of inhaled BDs (β2-agonist and/or anticholinergic), as add-ons to~     vasodilators, would be beneficial to PAH patients by reducing and/or delaying the rate of~     onset of DH, thus ameliorating the exertional symptoms in patients with stable PAH undergoing~     high-intensity constant work-rate (CWR) cycle endurance test.~      This is a randomised double-blind placebo-controlled crossover study. Design: 5 visits; V1:~     screening, familiarization, incremental cardiopulmonary exercise testing (CPET); V2: constant~     work-rate (CWR-CPET); V3, V4 and V5: CWR-CPET after intervention, in a random order: Placebo~     (P), Ipratropium Bromide (IB), Ipratropium Bromide + Salbutamol (IB+SALB).~   "
59957|NCT02782039|"~     The purpose of that register is to collect medical information about patients suffering of~     APS with or without associated SLE.~   "
59958|NCT02782026|"~     In this prospective case-control study, the investigators will evaluate the diagnostic~     performance of a novel electronic nose (E-nose) for the detection of Pulmonary Arterial~     Hypertension (PAH). This study is designed to:~        1. Assess the performance of the E-nose to discriminate controls from patients with PAH~        2. Assess the performance of the E-nose to discriminate between different subtypes of~          pulmonary hypertension (PH), namely idiopathic PAH, heritable PAH with BMPR2 mutation~          and chronic thromboembolic PH~        3. Assess the performance of the E-nose to discriminate controls from asymptomatic patients~          with PH who carry BMPR2 mutations.~   "
59959|NCT02782013|"~     Pneumonia is a common infectious disease of the lung, often requiring treatment in the~     hospital. Clinical scoring systems are available, identifying patients not requiring~     hospitalization. However, the course of disease of patients in the hospital remains hard to~     predict. While most patients will recover quickly, some will, despite appropriate treatment,~     develop a severe course leading to sepsis and systemic responses resulting in organ~     dysfunction. The PROGRESS study aims to identify clinical, genetic, and other molecular~     markers and combinations thereof predicting a severe course of pneumonia in the hospital.~     Such predictors will, for instance, support decisions on earlier transfer of patients to~     intensive care and thus improving outcome.~   "
59960|NCT02782000|"~     With the number of aged people increasing and the lifespan lengthen, dementia is becoming a~     great public challenge in China. Early recognition of dementia is crucial to improve the~     prognosis of dementia patients and decrease the society disease burden. It is a pity that the~     early recognition rate of dementia is less than 7% in China. Most of the aged people live in~     the community and general practitioners (GP) in community provide health service much more~     frequently than other medical workers. It is suggested that GPs should be the best one to~     screen dementia in its early period. However, most of GPs have not receive any training about~     dementia early recognition in China. It is imperative and meaningful to provide training to~     GPs for improve GPs' knowledge and skills about dementia early recognition. How to train GPs~     for early recognizing dementia and how about the training effect? Which training model may be~     better? We did not find consistent conclusion about these questions in China. This study aims~     to set up an effective and convenient model to training GPs in dementia early recognition. A~     total of 152 GPs in Beijing will be enrolled and be randomly divided into two groups. One~     group will firstly have lessons about dementia early recognition and then receive~     face-to-face supervision and key messages by Wechat about dementia early recognition once a~     month in the following 6 months. Another group will firstly have lessons about dementia early~     recognition and then receive face-to-face supervision and key messages by Wechat about~     dementia early recognition once a month in the following 3 months. The score of knowledge and~     attitude about dementia early recognition, the accuracy of analyzing dementia cases, the~     usage of dementia screening scales and the referral rate of dementia will be evaluated at~     different time point respectively. This study will provide evidence for training GPs~     effectively in dementia early recognition in the future and will promote dementia early~     recognition in community.~   "
59961|NCT02781987|"~     The purpose of this study is to compare the incidence of post-ERCP pancreatitis (PEP) in~     chronic pancreatitis (CP) patients to that in biliary disease patients, to determine whether~     CP patients in early clinical stage have a higher PEP incidence, and to identify the~     predictive and protective factors for PEP in chronic pancreatitis patients.~   "
59962|NCT02781974|"~     The study is a parallel-group single blinded randomized controlled trial, examining the~     effect of exercise on physical function in older women with osteoporosis and a history of~     vertebral fracture. The participants will randomly be assigned in a 1:1 ratio to the~     intervention group and the control group. The intervention will follow newly developed~     exercise recommendations for people with osteoporosis and vertebral fractures, which states~     the balance- and strength exercises should be performed at least twice a week. The~     intervention is a group exercise session circuit program lasting for 12 weeks. The~     participants will be tested at baseline, and followed up at 3 months and 6 months.~   "
59963|NCT02781961|"~     Previous studies have shown that histological changes in the gastric mucosa between obese and~     non-obese individuals do exist. Understanding these histological differences (between obese~     and non-obese individuals) might elucidate obesity pathophysiology.~      However, the data is scarce and even contradictory. Even less is known about the histological~     characteristics of the duodenal mucosa in obesity and lean states, but several studies~     already performed hint for some differences. These differences might influence gut hormones~     composition and function and play a crucial role in the development of obesity and metabolic~     syndrome. To our best knowledge, in-vivo, human, real-time cellular level comparison of~     gastric and duodenal mucosa has never been done. This can be now accomplished with pCLE.~      pCLE, is composed from a miniature microscope assembled in the tip of an optical fiber. This~     optic fiber is then inserted through the working channel of a standard endoscope, bringing~     the microscope at the tip of the fiber to close proximity with the tissue. The system applies~     a blue-light laser that after staining with fluorescein (IV 2.5 ml, 10% fluorescein, once)~     provides a cellular-level, in-vivo, real time images: the concept of so called optical~     biopsies. The system has been used as an auxiliary tool in GI-endoscopy in recent years.~     This technology has been shown to be useful in identifying objective histological features~     and even intramucosal bacteria in different tissues.~   "
59964|NCT02781948|"~     Evaluate the repeatability and reproducibility of iVue for measuring the total corneal~     thickness, the epithelial thickness, and the stromal thickness in normal subjects and~     patients with various corneal conditions.~   "
59965|NCT02781935|"~     The DREAM study will assess the diagnostic accuracy of diffusion-weighted MRI in combination~     with other imaging modalities (multiparametric MRI and CT Scan) in determining the true~     status of disappearing liver metastasis (DLM) detected after conversion systemic therapy for~     unresectable or borderline resectable colorectal liver metastasis (CRLM).~   "
59966|NCT02781922|"~     The purpose of this study is to evaluate the efficacy and safety of intracoronary injection~     of JRM-001 after reconstructive surgery in pediatric patients with functional single~     ventricle~   "
59967|NCT02781909|"~     Novel approaches to improve TB treatment outcomes (to reduce morbidity, mortality, and the~     duration of TB treatment) and to treat XDR-TB cases are urgently required. Host-Directed~     therapies (especially repurposed drugs such as Non-Steroid AntiInflammatory Drugs NSAIDS)~     could be useful in this context, and therefore its the appropriateness and potential effect~     of this approach needs to be evaluated in humans. Investigators do propose a prospective,~     randomized, pilot study to estimate the potential efficacy and safety of using adjunctive~     ibuprofen for the treatment of XDR tuberculosis.~   "
59968|NCT02781896|"~     The purpose of this study is to determine whether a left ventricular rapid pacing using the~     valve delivery guide-wire in transcatheter aortic valve implantation (TAVI) reduces the~     overall procedure duration in comparison with the conventional method.~   "
59969|NCT02781883|"~     The primary objective of this study is to assess whether the combination of BP1001 and LDAC~     provides greater efficacy (Complete Remission [CR], Complete Remission with incomplete~     hematologic recovery [CRi], Complete Remission with incomplete platelet recovery [CRp]) than~     LDAC alone (by historical comparison) in participants with AML that cannot or elect not to be~     treated with more intensive chemotherapy. Safety, pharmacokinetics, overall survival, time to~     response, and duration of response will also be studied.~   "
59970|NCT02781870|"~     This study aims to visualize the implanted mesh in vivo by MRI in 20 patients at 1 month and~     12 months post-operatively. Moreover, we want to evaluate the safety and efficiency of~     non-penetration mesh fixation techniques using pre-designed ENDOLAP 3D visible mesh placement~     versus mesh fixation using a synthetic LiquiBand Fix 8 glue for laparoscopic treatment of~     groin hernias.~      A total of 100 male and female patients will be entered in the trial in Maria Middelares~     Ghent, for which an inclusion period of 24 months is anticipated. Four surgeons of the~     department of surgery will screen all eligible consecutive patients for inclusion in the~     study. They will inform all patients about the surgery and the follow-up with MRI scan~     thereafter.~   "
59971|NCT02781857|"~     To answer the question whether a disease specific profile of breath in patients with lung~     cancer can be detected by an untargeted metabolomic study using exhaled breath analysis by~     mass spectrometry.~   "
59972|NCT02781844|"~     This study is being conducted to characterize the effects of twice daily administration of~     rhPTH(1-84) on the way the body handles rhPTH(1-84) as well as its actions and safety and~     tolerability over the course of 24 hours as compared with the current once daily dosing~     regimen of marketed rhPTH(1-84) (marketed in the United States as Natpara®).~   "
59973|NCT02781831|"~     Investigation of the clinical feasibility and efficacy of a newly developed robot-assisted~     gait training system for stroke survivors. It is anticipated that robot-assisted gait~     rehabilitation in combination with standard hospital based rehabilitation will achieve~     significantly better gait outcomes than standard hospital based rehabilitation alone.~   "
59974|NCT02781818|"~     Purpose: To evaluate the effectiveness of intralesional triamcinolone for the treatment of~     hidradenitis suppurativa (HS)~      Participants: Patients diagnosed with Hidradenitis Suppurativa that have active inflammatory~     HS lesions. Up to 60 lesions will be treated. Between 20 and 60 patients will be enrolled~     dependent on the number of lesions they have treated. (up to 3 per patient)~      Procedures (methods): Injection of triamcinolone or placebo into active lesions of~     hidradenitis suppurativa~   "
60060|NCT02780700|"~     The objective of this Phase II study is to assess the efficacy and safety of nintedanib alone~     or in combination with capecitabine for patients with refractory mCRC after failure of at~     least 2 lines of standard treatment~   "
59975|NCT02781805|"~     The goal of this study is to mechanistically define the potential anticancer activities of~     the osteoporosis bisphosphonate (BP) drug alendronate, and extend the analysis to learn novel~     information about the impact of BP on gamma delta (γδ) T cells in breast tissues as well as~     epithelial breast cell differentiation of high-risk women. To this end, we have designed a BP~     window trial to examine the effect of 1 - 3 weeks administration of alendronate on women at~     high-risk for breast cancer, at the level of immunosurveillance and mammary epithelial cell~     differentiation.~   "
59976|NCT02781792|"~     Temozolomide (TMZ) is the chemotherapy drug approved by the FDA to increase survival in~     glioblastoma (GBM) patients beyond surgical resection and radiation therapy alone. Give its~     activity in astrocytomas, TMZ is commonly used in grade III anaplastic astrocytoma (AA) as~     well. Both grade III AA and grade IV GBM are high grade gliomas (HGG). The short half-life of~     this drug and known oscillations in DNA damage repair make it an ideal candidate for~     chronotherapy.~      Chronotherapy is the improvement of treatment outcomes by minimizing treatment toxicity and~     maximizing efficacy through delivery of a medication according to the timing of biological~     rhythms within a patient. Chronotherapy has improved outcomes through the reduction of side~     effects and increase in anti-tumor activity for a variety of cancers, but has never been~     applied to the treatment of gliomas.~      Based on the preliminary preclinical data for chronotherapeutic TMZ treatment of intracranial~     glioma xenografts and the success of chronotherapy in the treatment of other cancers, the~     invesitgators hypothesize that the timing of TMZ treatment will alter its efficacy and~     toxicity.~   "
59977|NCT02781779|"~     The purpose of this study is to learn how effective each of the two dressings, Silverlon® and~     AQUACEL® AG, are in preventing post cardiac implantable electronic devices (CIED) procedure~     wound infections.~   "
59978|NCT02781766|"~     Haemophilic arthropathy is one of the major complications of severe haemophilia. In order to~     maintain plasma clotting factor activity levels above 1% and avoid spontaneous joint bleeds~     and other serious bleeding events, prophylactic factor replacement therapy is used. Because~     of the high cost and limited availability of clotting factor concentrates, dosing is a~     crucial issue for prophylaxis therapy. Several studies reported a better correlation between~     clinical bleeding tendency of patients with haemophilia and thrombin generation assay results~     compared to FVIII/FIX levels. However there is no specific data showing that thrombin~     generation may be a better indicator of the clinical efficacy of prophylaxis compared to the~     conventional FVIII measurement.~      The main objective of this open, multicentre, prospective study is to compare trough thrombin~     generation capacity and FVIII levels in severe haemophilia patients and compare these two~     laboratory results with:~        -  the number of spontaneous haemarthroses and other spontaneous serious bleeds occurred in~          the last 6 months~        -  the number of additional FVIII units used in the last 6 months~      This project requires no change in term of type of treatment : During the study, each patient~     will be treated by his usual clotting factor at the usual regimen (frequency and dosage).~      The clinical outcome with the usual prophylaxis regimen will be correlated to TGA results~   "
59979|NCT02781753|"~     The purpose of this study is to evaluate the dosages of recombinant human serum~     albumin/interferon alpha2b fusion protein injection in healthy subjects.~   "
59980|NCT02781740|"~     Obstructive sleep apnoea (OSA) is a highly prevalent sleep-related breathing disorder. The~     most effective treatment for OSA is continuous positive airway pressure (CPAP). CPAP therapy~     has been shown to significantly reduce subjective sleepiness and blood pressure in patients~     with symptomatic OSA. Its effectiveness tends to depend on its nightly usage and a commonly~     held view is that CPAP should be used for at least 4h/night. However, previous studies have~     estimated that a considerable proportion of CPAP users fail to achieve this. In addition,~     there is inadequate evidence to support this apparent threshold effect and so it is unclear~     whether such patients actually benefit from treatment or whether they could be withdrawn from~     CPAP, thus substantially reducing health care costs, or encouraged to increase their nightly~     usage of CPAP.~      The aim of the proposed project is to study the effect of CPAP withdrawal on subjective~     sleepiness in OSA patients using CPAP for less than 4h/night on average. We hypothesize that~     two-week CPAP withdrawal in patients with 3-4h/night use will lead to a return of OSA-related~     symptoms. This trial will better establish the minimum level of CPAP adherence which could~     generally be regarded as effective in reducing OSA-related symptoms.~   "
59981|NCT02781727|"~     A 52 week trial of TransCon hGH, a long-acting growth hormone product, versus human growth~     hormone therapy. TransCon hGH will be given once-a-week, human growth hormone (hGH) will be~     given daily. Approximately 150 prepubertal, hGH-treatment naïve children (males and females)~     with GHD will be included. Randomization will occur in a 2:1 ratio (TransCon hGH :~     Genotropin). This is a global trial that will be conducted in, but not limited to, the United~     States, Canada, Germany, France, Poland, Bulgaria, Russia and Australia.~   "
59982|NCT02781714|"~     Meeting women's need for postpartum family planning is has been acknowledged as a global~     priority in maternal and child health. The prevention of unintended pregnancies in~     sub-Saharan African countries, which carry the highest global burdens of maternal mortality~     and HIV infection, is projected to substantially decrease maternal and neonatal morbidity and~     mortality. Many barriers to contraceptive uptake exist, both within and outside of the~     postpartum time period, and include socio-cultural, economic, and supply-side factors.~     Furthermore, while the importance of engaging men in family planning programs has been~     acknowledged for decades, few interventions have succeeded in increasing male involvement in~     family planning while maintaining a focus on women's empowerment. Innovative approaches to~     meeting the family planning needs of women and couples are urgently needed.~      Public health interventions are increasingly incorporating mobile health (mHealth) approaches~     using short message service (SMS) technology in low-income countries, approaches that have~     demonstrated benefit among various reproductive health outcomes. The investigators~     hypothesize that personalized, bidirectional SMS dialogue with individual women and couples~     will increase postpartum contraceptive uptake, thereby decreasing unmet need for family~     planning in Kenya. The investigators have collaborated with the University of Washington (UW)~     Department of Computer Science and Engineering (CSE) along with Kenyan telecommunication~     providers to develop a hybrid messaging system that allows for innovative bidirectional SMS~     messaging. This system has been used successfully in maternal child health (MCH) clinics in~     Kenya. In qualitative research, women in Kenya have expressed a strong desire for mHealth~     support to provide additional education, counseling and reminders to supplement counseling by~     health workers.~      The investigators propose a randomized controlled trial (RCT) comparing the effects of~     bidirectional SMS dialogue vs. control on highly effective contraceptive use at 6 months~     postpartum among HIV negative women and couples in Nyanza Province, Kenya. Data from this RCT~     and accompanying qualitative study will contribute to innovative, scale-able strategies to~     address unmet need for contraception and increase male involvement in family planning.~   "
60295|NCT02777632|"~     The purpose of this work was to study the incidence, types, risk factors and causative~     organisms of bacterial infections in HCV Egyptian patients following Liver Transplantation.~     Moreover, to identify the emerging resistant strains and their proper antimicrobial therapy~   "
59983|NCT02781701|"~     From Weill Cornell Medical College Center for Sleep Medicine, the investigators will recruit~     patients (N = 25) with previously documented moderate to severe OSA. They will receive an~     all-night in-home sleep study to document the severity of their OSA immediately before~     starting the training regimen. Scales and questionnaires measuring sleepiness, snoring,~     fatigue, and insomnia will be administered prior to starting the training and repeated after~     six weeks of training. Subjects may be removed from the study due to failing to adhere to the~     training regimen at anytime via remote data monitoring. The principal measure of the efficacy~     of the treatment will be the change in RDI, the number of abnormal breathing events per hour~     of sleep.~   "
59984|NCT02781688|"~     Pilot study to assess a multi-component intervention to increase physical activity in persons~     with depression.~   "
59985|NCT02781675|"~     A Mediterranean dietary pattern emphasizing an abundance of plant-based foods including nuts,~     moderate intakes of fish, poultry and low-fat dairy products, and use of extra virgin olive~     oil as the main source of fat has been associated with reduced risk of cardiovascular disease~     (CVD), and such a pattern has been advocated by the 2015 U.S. Dietary Guidelines Advisory~     Committee. The strongest experimental support for this recommendation derives from the~     success of the recent PREDIMED CVD outcomes trial, and studies indicating that a~     Mediterranean-style diet improves lipoprotein and oxidative markers of cardiovascular disease~     risk in comparison to either low-fat or Western dietary patterns. However, in none of these~     studies were comparisons made between the effects of Mediterranean-style diets with~     low-/nonfat vs. full-fat dairy foods. The overall objective of the present proposal is to~     determine whether the inclusion of full-fat rather than low- and nonfat dairy foods in a~     Mediterranean dietary pattern based on that used in the PREDIMED study results in similar~     improvements in biomarkers of CVD risk. Specifically, we will test the hypotheses that 1) a~     standard Mediterranean diet will lower LDL-C and apoB compared to a Western diet; 2)~     modification of the Mediterranean diet by replacing low-fat dairy products with high-fat~     dairy (3 servings/day; high-dairy fat Mediterranean diet) will not significantly increase~     LDL-C and apoB but may raise large buoyant LDL particles compared with a standard~     Mediterranean diet; and 3) the high dairy fat and standard Mediterranean diets will result in~     comparable reductions in levels of inflammatory markers and oxidized LDL, and improvements in~     endothelial function compared to a Western diet.~   "
59986|NCT02781662|"~     This study evaluates an intervention to reduce medication errors and adverse drug events in~     older adults who have recently been discharged from the hospital and prescribed~     anticoagulants, diabetes agents, or opioids. Half of the study participants will receive the~     intervention, while the other half will receive usual care.~   "
59987|NCT02781649|"~     In this study, individuals without hepatitis C infection who are on the kidney transplant~     waitlist will receive a kidney from a deceased donor with hepatitis C infection and will be~     treated for hepatitis C at the same time. Treatment will include Grazoprevir (GZR) 100~     mg/Elbasvir (EBR) 50 mg administered on-call to the operating room for the renal transplant~     procedure and continued for 12 weeks post-renal transplant.~   "
59988|NCT02781636|"~     30 patient Study. All patients implanted with StimGuard Protect System. Patient followed out~     to 90 days.~   "
59989|NCT02781623|"~     This study will quantify and examine the extent to which the quadriceps femoris muscle group~     atrophies following tibial plateau fractures and the length of time that atrophy affects~     function. The study will also look at the effects of tibial plateau fractures on the~     quadriceps muscle and the effect this atrophy has on functional outcome. Quadriceps atrophy~     will be measured both clinically and by using MRI scans taken pre-operatively, 3 months post~     operatively, and 1 year post-operatively. The injured leg and the non-injured leg will be~     scanned in order for the non-injured leg to serve as the control. In this way muscle volume~     can be estimated from the muscle thickness at specific locations in the thigh. The muscle~     strength of the quadriceps will also be assessed at the 3 month and 1 year visit by measuring~     isokinetic knee-extension torque, and functional assessment questionnaires will be completed~     at each study visit.~   "
59990|NCT02781610|"~     Cystic fibrosis (CF), a life-shortening genetic disease, is marked by acute episodes during~     which symptoms of lung infection increase and lung function decreases. These pulmonary~     exacerbations are treated with varying antibiotics for varying time periods based on needs~     determined by individual patients, their families, and the health care providers. Cystic~     fibrosis pulmonary guidelines for the treatment of pulmonary exacerbation published by the~     Cystic Fibrosis Foundation (CFF) in 2009 provided recommendations for treatment and also~     identified key questions for which additional studies were needed.~      A strong desire among clinicians to reduce treatment durations (and reduce cost,~     inconvenience, and potential toxicities) is in conflict with belief that patients not~     responding robustly to treatment might benefit from extending treatment.~      This randomized, controlled, open-label study is designed to evaluate the efficacy and safety~     of differing durations of IV treatment, given in the hospital or at home for a pulmonary~     exacerbation in adult patients with CF.~   "
59991|NCT02781597|"~     The purpose of study is to evaluate the efficacy of tranexamic acid in controlling bleeding~     in patients of hemoptysis and also to evaluate the safety of tranexamic acid.~   "
59992|NCT02781584|"~     The primary objective of this study is to evaluate the safety and tolerability of selonsertib~     (SEL; formerly GS-4997), GS-0976, and GS-9674 in adults with nonalcoholic steatohepatitis~     (NASH).~   "
59993|NCT02781571|"~     This study will evaluate the efficacy, safety, and tolerability of sofosbuvir /velpatasvir~     (SOF/VEL) fixed-dose combination (FDC) in participants with chronic hepatitis C virus (HCV)~     who have received a liver transplant.~   "
59994|NCT02781558|"~     This study will evaluate the efficacy, safety, and tolerability of sofosbuvir /velpatasvir~     (SOF/VEL) fixed dose combination (FDC) and SOF/VEL FDC and Ribavirin (RBV) for 12 weeks in~     participants with chronic genotype 3 HCV infection and compensated cirrhosis.~   "
60139|NCT02779660|"~     The aim of the study is to examine the effect of RIPC on physiological parameters in~     non-valvular paroxysmal atrial fibrillation. Furthermore the study will provide a unique~     bio-date base for further analysis of molecular and genetic mechanisms responsible for~     observed results.~      The potential effect of RIPC on AF inducibility and/or prothrombotic activity might be~     implemented as additional treatment component to reduce AF burden and minimize thromboembolic~     risk.~      Interim Analysis will be done after 73 patients.~   "
59995|NCT02781545|"~     Infants requiring surgery in the neonatal period for complex congenital heart diseases are at~     risk for developmental problems. For infants with congenital heart diseases with admixture~     physiology and single ventricles, optimal circulation is associated with signs of adequate~     systemic perfusion and a systemic arterial oxygen saturation typically between 75% to 90%.~     Infants are often unable to withstand standardized developmental testing during early infancy~     due to medical fragility and sternal precautions after surgery. Evaluation of the quality of~     spontaneous movements and movement variability is a good alternative. The quality of general~     movements in early infancy is a valid predictor of neurological disorders in high risk infant~     groups and is assessed with short periods of video-recorded observations. This methodology~     has yet to be studied in infants with complex congenital heart disease that require surgery~     as neonates. For older infants, the Infant Motor Profile (IMP) is a promising tool to~     document developmental outcome.~   "
59996|NCT02781532|"~     The main objective of our study is to determine if the evaluation of ingesta of cancer~     patients by VAS (on the day of hospitalization) is able to predict the actual ingesta of~     patients during hospitalization (for patients malnourished, at risk of malnutrition or risk~     free).~   "
59997|NCT02781519|"~     The purpose of the study is to characterize the acute effects of cannabinoids in women~     relative to men and to begin probing the mechanisms that may underlie gender differences.~   "
59998|NCT02781506|"~     Nivolumab (brand name Opdivo): IV, 3 mg/kg q2 weeks, until disease progression or~     unacceptable toxicity; SABR, dose variable, in 1-3 fractions.~   "
59999|NCT02781493|"~     Prucalopride based bowel cleansing regimen might be helpful to improve bowel cleansing~     quality before colonoscopy.~   "
60000|NCT02781480|"~     A clinical trial of AAV2/5 vector for patients with Defects in RPE65~   "
60001|NCT02781467|"~     This study will find the highest acceptable treatment dose of cord blood, culture expanded~     natural killer (NK) cells, a kind of immune cell, in patients with relapsed and/or refractory~     acute myeloid leukemia.~      The NK cells will be given with chemotherapy and Recombinant human interleukin 2 (rhIL-2) to~     help the NK cells expand in the body. The safety of this treatment will be studied and~     researchers want to learn if NK cells will help in treating the AML.~   "
60002|NCT02781454|"~     The purpose of this research study is to find out whether the drug mexiletine will be~     effective in lowering motor neuron electrical activity in the brains and nerves in the arms~     of people with ALS. The investigators will also determine if there are any signs that the~     drug may slow down the progression of ALS and reduce muscle cramps and muscle twitching. This~     will be determined through transcranial magnetic stimulation (TMS) and threshold tracking~     nerve conduction studies (TTNCS). In this trial, the participants will be taking either~     300mg/day of mexiletine, 600mg/day of mexiletine, or placebo (non-active study drug).~   "
60003|NCT02781441|"~     MDS are a diverse group of hematopoietic malignancies, which mainly occur in patients over 75~     years of age. Incidence rate in 2012 in France was more than 6 cases per 100 000~     person-years. MDS are characterized by ineffective haematopoiesis causing cytopenia, and by~     leukemic transformation. The disease is heterogeneous, its pathophysiology complex and~     clinical evolution variable.The few data available on MDS patients show how difficult it is~     to understand MDS, its prognosis and the reasons for prescribing or not some treatments. In~     the context of a highly complex potentially lethal disease such as MDS, it is of utmost~     importance to optimize the information conveyed to patients. Particularly, 70.5% of MDS~     patients surveyed in our developmental study would have preferred more information about~     prognosis at diagnosis disclosure.~      A simple intervention based on the use of a question prompt list (QPL), would greatly improve~     the information process by helping patients to express their main concerns at their medical~     consultations. Cultural differences may exist in the appraisal of QPLs and QPLs have not yet~     been widely used in France.~      However, in line with the previous results available in the literature and in a context a~     priori favourable to the use of such an instrument, the investigators hypothesise that use of~     a QPL will increase MDS patients' expressions of concerns and questions at their medical~     consultations. Particularly the investigators assume that the discussion about prognosis will~     be facilitated, without increasing anxiety because patients remain free to ask or not for~     such information. The use of QPLs would also be a way to limit social inequalities related to~     insufficient information and to encourage patient-doctor communication and meeting of patient~     preferences which could lead to better health outcomes.~   "
60004|NCT02781428|"~     This is a prospective multicentre observational study to assess the sensitivity of the~     UroMark assay to detect bladder cancer in participants with new or recurrent disease. The~     study will recruit patients with newly detected or recurrent bladder cancer. The reference~     standard will be histopathological confirmation of tumour stage and (Ta, T1, ≥T2) and grade~     1, 2 or 3 diseases with or without CIS, or CIS alone.~      Patients with a visual diagnosis of bladder cancer following cystoscopy will be approached~     and asked to consent for this study. Consenting participants will be provided with a urine~     sample collection kit and asked to provide a urine sample. Samples can be provided at home~     and posted to the receiving lab using the stamped addressed envelope. The urine sample must~     be obtained before TURBT and following TURBT, patients with NMIBC who require surveillance~     cystoscopy will be asked to provide a urine sample at 3 monthly intervals for up to 2 years.~      The study will be conducted in at least 11 NHS trusts. As DETECT II is an observation study~     requiring provision of a urine sample, it will be possible for patients in DETECT II to be~     recruited to other trials.~   "
60005|NCT02781415|"~     The aim of this study is to compare the clinical efficacy and safety profiles of a 30 minutes~     acupuncture session performed at an ER of a tertiary hospital versus titrated intravenous~     morphine in the management of acute severe pain syndromes (defined as a visual analogue scale~     (VAS) score >/= 70) taking for example acute renal colic.~   "
60032|NCT02781064|"~     Statins are known to cause rare but serious side effects such as rhabdomyolysis (breakdown of~     muscle tissue) but many patients stop taking statins due to less severe symptoms, such as~     muscle pain or fatigue.~      This study aims to determine whether symptoms occurring during statin use are caused by~     statins. The trial will compare patient-reported side effects of statins (20mg atorvastatin)~     vs. placebo.~      Patients will be randomized to alternating treatment blocks of either statin or placebo split~     into six two-month treatment periods. At the end of each period, patients will be asked to~     self-report side effects using a website or mobile app.~   "
60006|NCT02781402|"~     World Health Organization (WHO) defined body mass index (BMI) as the ratio of weight in~     kilograms to the square of the height in meters (kg/m2). BMI has been used widely to diagnose~     obesity as it is a simple method to be carried out and is also inexpensive. According to WHO,~     there were 1.9 billion overweight individuals in 2014 with the age of 18 years old or above.~     Of 1.9 billion overweight individuals, there were 600 million obese adults. The prevalence of~     cardiovascular disease is higher among the overweight and obese individuals compared to~     individuals with normal body mass index. This probably is due to altered cardiovascular~     autonomic regulation. The risk of getting cardiovascular diseases is also higher among~     physically inactive individuals. As much as 60% of American adults are not regularly active~     and 25% of them are not active at all. Obese and overweight individuals tend to be physically~     inactive and it has been shown that there is a negative relationship between BMI and heart~     rate recovery (HRR). HRR is defined as difference in heart rate between maximum exercise and~     1 minute later during recovery period after stopping of exercise. HRR after exercise stress~     is due to withdrawal of sympathetic nervous system and the reactivation of parasympathetic~     nervous system. Parasympathetic nervous system is altered in obese individuals therefore~     leading to poor HRR after exercise. Aerobic training not only can reduce the body composition~     but also improves the autonomic cardiovascular control. There is limited literature support~     for any study which shows that potential of 4 weeks aerobic training can influence the heart~     rate recovery in sedentary healthy adults. Most of studies conducted were using minimum of 6~     to 8 weeks of aerobic training. The potential of 4 weeks of aerobic training in improving the~     autonomic nervous system among sedentary adults is still unclear. Therefore, we hypothesized~     in our study that there will be effect of 4 weeks of aerobic training on vagal modulation.~   "
60007|NCT02781389|"~     The aim of this non-interventional study is to provide further data on the utilization,~     effectiveness, safety and clinical benefit including duration of response of Vismodegib for~     treatment of locally advanced basal cell carcinoma (laBCC), inappropriate for surgery or~     radiotherapy under real world clinical conditions.~   "
60008|NCT02781376|"~     Obstructive Sleep Apnea (OSA) is prevalent in children and adolescents and associated with a~     variety of negative consequences affecting health and cognitive functioning. While clinical~     guidelines outline effective strategies for the diagnosis and management of pediatric OSA,~     rates of screening, identification, and management in primary care settings remain low. The~     aim of the current study is to evaluate the use of a computer decision support system module~     (CHICA-OSA) designed to improve adherence to OSA guidelines in pediatric primary care~     clinics. All children ages 1-11 years will be screened for snoring and other symptoms of OSA~     in the waiting room prior to a visit to their primary care provider (PCP). In clinics~     randomly assigned to CHICA-OSA, caregivers of snoring children will report on additional OSA~     symptoms, and PCPs will receive automated prompts in the electronic health record (EHR) to~     provide evidence-based evaluation and appropriate referral for testing. For children sent for~     polysomnography (PSG), PCPs will receive automated prompts to reassess symptoms at the next~     visit. We hypothesize that clinics using CHICA-OSA will have better adherence to guidelines,~     as evidenced by higher rates of identifying OSAS, referral for PSG, and re-assessment~     following treatment.~   "
60009|NCT02781363|"~     The Thoracic ultrasound is a safer and sensitive technique than conventional radiography~     because it detects less than 1 cm pneumonic consolidations and minimal pleural effusions. The~     main objective is to evaluate the efficacy of thoracic ultrasound performed by unskilled~     personnel in the emergency service prdiatricas to diagnose pneumonia in children.~   "
60010|NCT02781350|"~     The main objective of this research is to investigate the effect of addition of fiber on the~     high fat high carbohydrate (HFHC) meal induced inflammation and oxidative stress mechanisms~     at the molecular level in humans, in vivo. The investigators have previously shown that the~     intake of one HFHC meal leads to an increase in oxidative stress and inflammation. HFHC meal~     also induces an increase in the expression of suppressor of cytokine signaling- 3 (SOCS-3) in~     the mononuclear cells (MNC), which interferes with insulin signal transduction and~     contributes to the pathogenesis of insulin resistance. In contrast, an American heart~     association (AHA) meal rich in fruits and fiber does not induce these effects. These~     observations are important since HFHC meal not only induces oxidative stress and inflammation~     but also lays the foundations of a potentially greater insulin resistance through the~     induction of SOCS-3, TLR-4 and TLR-2.~   "
60011|NCT02781337|"~     This is a Registry that invites patients undergoing colorectal surgery for colorectal cancer.~     Epidemiological data is collected. The Registry includes tumor tissue and blood banks for~     analyzing different genetic mutations and disease-specific biomarkers.~   "
60012|NCT02781324|"~     The primary purpose of this randomized trial is to compare the efficacy of an ultrasonic bone~     scalpel (or osteotome device) with standard of care surgical instruments during posterior~     spine fusion with instrumentation.~   "
60013|NCT02781311|"~     This study will evaluate the safety, tolerability and efficacy of the oral administration of~     setipiprant tablets 1000 mg twice daily (BID) relative to placebo in 18 to 49 years old males~     with androgenetic alopecia (AGA).~   "
60014|NCT02781298|"~     This study evaluates a new infant cereals on acceptability, tolerance, satiety and prebiotic~     effect in infants.~   "
60015|NCT02781285|"~     The researching subject is aimed to obtain the clinical evidences (including real benefits，~     risks ,etc. ) of traditional Chinese medicine in the treatment of advanced gastric cancer by~     compared with the outcomes that not accept the traditional Chinese medicine. the subject~     acquires these clinical practices by using the methods of multicenter、persisting registry~     (the real world researching technology ) and propensity score.~   "
60016|NCT02781272|"~     ANGLE has developed the Parsortix™ Cell Separation System (Parsortix), an automated system~     capable of harvesting rare circulating cells for analysis from a sample of peripheral blood~     based on cellular size and deformability. In a small pilot study, scientists at the Medical~     University of Vienna demonstrated that measurement of a combination of mRNA markers extracted~     from CTCs captured using the Parsortix system could be used to identify women with ovarian~     cancer. This study is designed to provide specimens for optimization of an assay using~     clinical and biomarker information (i.e. demographics, imaging results and/or serum tumor~     markers) in combination with mRNA extracted from rare cells in the blood of women presenting~     with a pelvic mass for the detection of malignancy.~      Primary Objective: Optimization of an assay/algorithm for the differentiation of women with~     benign pelvic masses from those with malignant pelvic masses using clinical and biomarker~     information (i.e. demographics, imaging results and/or serum tumor markers) in combination~     with mRNA markers extracted from rare cells isolated from whole blood. Multiple serum protein~     markers and mRNA markers will be measured, and the results will be compared to the actual~     clinical diagnosis made for each subject through other recognized methods (i.e.~     histopathology). Statistical modeling will be used to combine the clinical information, serum~     protein markers and/or mRNA markers for estimation of the risk of malignancy. If successful,~     the resulting risk algorithm will be evaluated in future, appropriately powered, prospective~     studies.~      Exploratory Objective: Use statistical modeling to determine the need for and/or preliminary~     design of a mathematical algorithm to combine the clinical information, serum protein markers~     and/or mRNA markers for estimation of the risk of malignancy.~   "
60017|NCT02781259|"~     In this study, navigation of lymphatic passage after sentinel lymph node with indocyanine~     green was performed during axillary lymph node dissection in breast surgery . By comparing~     the concordance between the passage of indocyanine green and actual lymph node metastasis,~     selective lymph node dissection can be developed.~   "
60021|NCT02781207|"~     This is a observational prospective study. For patients presenting to the Emergency~     Department with loss of consciousness, emergency physicians will be asked to screen the real~     syncope without an evident and immediate cause for the loss of consciousness (e.g. vasovagal)~     and/or at least one high risk condition as listed by the European Society of Cardiology in~     the 2009 Guidelines for the diagnosis and management of syncope (i.e. severe structural or~     coronary artery disease, clinical or ECG features suggesting arrhythmic syncope, and~     important co-morbidities).~      In case of a real syncope not clearly physiopathologically explained and no high risk~     conditions, the emergency physician in charge will check risk factors for high risk syncope~     and categorize again every cases.~      A high risk syncope is characterized by at least one high-risk characteristic (based on 2015~     Syncope clinical management in the emergency department consensus): syncope during~     exertion, in supine position, with new onset of chest discomfort, palpitations before the~     loss of consciousness, family history of sudden death, congestive heart failure, aortic~     stenosis, left ventricular outflow tract disease, dilated cardiomyopathy, hypertrophic~     cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, left ventricular ejection~     fraction <35%, previously documented ventricular arrhythmia, coronary artery disease,~     congenital heart disease, previous myocardial infarction, pulmonary hypertension, previous~     ICD implantation, anemia (i.e. Hb <9 g/dl), lowest systolic blood pressure in the ED <90~     mmHg, sinus bradycardia (<40 bpm), new (or previously unknown) left bundle branch block,~     bifascicular block plus a first degree AV block, Brugada ECG pattern, ECG changes consistent~     with acute ischemia, a new non-sinus rhythm, bifascicular block, and a prolonged QTc (>450~     ms).~      Low and intermediate risk syncopes will be enrolled and evaluated using an integrated~     point-of-care sonographic approach (based on history, physical exam, electrocardiogram, and~     lung, focus cardiac and venous compression ultrasonography).~      After discharge, the risk of patient's syncope will be determined by reviewing the entire~     medical records.~   "
60022|NCT02781194|"~     The aim of this investigation is to assess the impact of forced air warming, warm humidified~     insufflation gas and the combination of the two on intraoperative temperature maintenance and~     the postoperative pain course as well as the fibrinolytic activity in peritoneal fluid~     following laparoscopic procedures (duration > 60 min) in a prospective, randomized,~     controlled, mono-centric study. Therefore 150 subjects will be randomized in 3 groups of 50~     subjects each. First group will be treated with forced-air warming blanket (bair hugger).~     Second group will be treated with warmed, humidified insufflation via the F&P HumiGard™~     Surgical Humidification System. Third group will be treated with both, warming blankets and~     warmed, humidified insufflation. The peri-operative temperature of patients might be higher~     in patients of the third group with the combination of both treatments. The investigators~     hypothesize that VAS scores for pain (especially shoulder pain), and MEDD usage will differ~     between groups. Wound infection incidence and time spent in PACU are also expected to differ.~     Fibrinolytic activity in the peritoneal fluid is expected to be higher in patients undergoing~     laparoscopic procedures with humidified gas insufflation, since the trauma to the peritoneum~     will be less.~   "
60023|NCT02781181|"~     A recent randomized Carotid artery stenting (CAS) trial in which carotid protection device~     (CPD)s were used to demonstrate equivalence with carotid endarterectomy (CEA) by achieving~     noninferiority regarding periprocedural risk. However, the clinical efficacy and safety of~     CPDs are still a matter of controversy. It has been argued that the limited reduction~     provided by CPDs may be due to the devices themselves. Probably, they serve as sources for~     emboli during the procedure or removal technique. In general, 30- day adverse outcome for CAS~     with the use of CPDs seems not to be different from the outcome without CPDs.~      Thus, the main goal in this study is to test the hypothesis that CAS without CPD usage is as~     safe as in those patients who undergo CAS with CPD neuroprotection.~   "
60024|NCT02781168|"~     The aim of this study was to investigate the influence of the use of headphones in salivary~     cortisol levels in newborns (NB) during periods of nap aimed at noise reduction, brightness~     and handling NB, measure the concentrations of salivary cortisol before (baseline) and after~     the use of hearing protection (response) in the neonatal intensive care unit (NICU).~      A NICU nap periods and compare the influence of the use and non-use of hearing protection in~     salivary cortisol levels and sleep patterns of infants during nap periods of the NICU.~   "
60025|NCT02781155|"~     This study investigates whether it is feasible to teach cancer patients undergoing~     chemotherapy to self-administer daily moxibustion to reduce chemotherapy side effects.~     Moxibustion is a therapy used in traditional Chinese medicine that uses heat.~   "
60026|NCT02781142|"~     Motor imagery training facilitates the neural plasticity with increasing the neuronal~     cortical pathways in the brain. Motor imagery training is an effective way in stroke~     survivors. However, its effects in persons with multiple sclerosis (MS) are not known.~     Additionally, telerehabilitation based motor imagery training is very rare treatment way~     which requires more research. Therefore, this study aims to investigate the effect of~     telerehabilitation based motor imagery training on gait and balance performance of the~     persons with MS.~      The participants will be allocated into three groups, including motor imagery training,~     wait-list control group, and healthy control group.~      All the assessments will be performed before and after the training in the 8-week motor~     imagery training group. The participants in the control group will underwent the assessment~     with a 8-week interval. The healthy participants will be assessed only one.~      The motor imagery training will be designed for the individual basis with following standard~     protocols. It will be applied two times a week for 8 weeks. The first one and/or two sessions~     will be performed in the clinic, the other will be performed at the patients' home with a~     video-conference telerehabilitation technique.~   "
60027|NCT02781129|"~     This study is designed to identify brain activity associated with good memory in subjects~     with a chronically implanted RNS® device and to study the effects of therapeutic stimulation~     for epilepsy on memory. This will be accomplished through analysis of ECoG data collected~     during memory encoding for short and long-term free recall as well as during navigation~     tasks.~   "
60028|NCT02781116|"~     This study will have great impact and influence in the medical setting as the targeted model~     that will be derived from this study will be the pioneer in our region. This model will be~     beneficial in identifying risk factors and its association with the Arab women population.~     Furthermore, it will bring chemotherapy prevention once the risk factors and the model are~     established. Risk factors maybe different from those identified in western women by Gail and~     IBIS Models~   "
60029|NCT02781103|"~     This is a single blind, randomized controlled pilot trial of transcranial direct stimulation~     (tDCS) intervention or tDCS sham administered with a standardized guided imagery~     intervention. Up to 25 adult women with chronic pelvic pain will be enrolled and randomized~     (like a flip of the coin) to achieve a total sample size of 20 women. 10 women in one arm of~     the study will receive guided imagery with tDCS stimulation. 10 women in the other arm of the~     study will receive guided imagery with sham tDCS. Subjects will remain blinded until the end~     of the study.~   "
60036|NCT02781012|"~     This sample-collection study is open to participants in several categories: healthy~     volunteers (with or without a family history of pancreatic cancer) and individuals diagnosed~     with pancreatitis or any stage of pancreatic cancer. All participants will submit urine,~     saliva and blood samples; pancreatitis and pancreatic cancer patients will also submit tissue~     samples if biopsy/ies or surgery is part of the care being provided by their doctor. In~     partnership with Berg Health, LLC, biomarkers will be investigated for potential use in early~     detection of pancreatic cancer, to determine prognosis of patients, and to find the most~     appropriate treatments for patients.~   "
60037|NCT02780999|"~     The aim of this study is to compare the effect of Whale and Colditz static orthosis on pain~     and functional abilities of hand in thumb carpometacarpal osteoarthritis as a unique~     treatment.~      Patients with thumb CMC OA will be recruited at Tecan Hand Center Clinic. Participants will~     be assigned using a randomized allocation in two groups. For group A a Whale orthotic will~     be constructed and for group B a Colditz orthotic. Both static splint will endorse for 3~     months. Inclusion criteria for this study were adult over 18 diagnosed with carpometacarpal~     joint osteoarthritis with a pain intensity during Activities of Daily Living (ADL's) up to 4~     / 10 on the Visual Analog Scale (VAS).~      Patients were excluded from participation if they had: a neurological disorder affecting the~     upper limb; had received previous treatment for their hand problem in the last 6 months~     including an intra-articular joint injection to wrist, fingers or thumb; had fractures or a~     significant hand injury or previous surgery to the wrist or hand; had hand or finger~     tenosynovitis and/ or Dupuytren's disease. Were also excluded patients who did not complete~     Dash Spanish version questionnaire or if they did not sign the informed consent.~      The outcome measure will be pain intensity and functional abilities as measured with the~     Visual Analogue Scale (VAS) and Disabilities of the Arm, Shoulder and Hand (DASH),~     respectively. All measures will be collected at baseline and end of the intervention.~   "
60038|NCT02780986|"~     The investigators aim to assess the efficacy of a multi-component intervention on condom use~     and sexually transmitted infection (STIs) in female entertainment workers and men frequenting~     entertainment establishments (EEs), using a quasi-experimental design. Joo Chiat and Golden~     Mile Complex will be selected purposively as control cluster sites (n=220) with follow-up of~     entertainment workers at 6 weeks. The same sites will be used as intervention sites after a~     3-months 'wash out' period. Self-reported condom use, vaginal swab samples for polymerase~     chain reaction (PCR) for cervical gonorrhoea and chlamydia infections, and throat swabs for~     culture for pharyngeal gonorrhoea will be assessed. Clark Quay will be the intervention venue~     for the heterosexual men while Tanjong Pagar will be the equivalent control site. Using time~     location sampling, cross-sectional samples of men patronising these establishments will be~     assessed on self-reported condom use at baseline (n=600) and 6 months after the intervention~     (n=400) in both intervention and control groups.~   "
60039|NCT02780973|"~     Healthy volunteers are observationally wearing an intraoral device with bovine tooth samples~     once for two hours. Afterwards, Calcium release from the bovine enamel and dentin samples is~     measured after extraoral erosion.~      Total protein concentration within the formed salivary pellicles on the bovine samples is~     determined. Further Salivary parameters (unstimulated and stimulated saliva flow rate, pH,~     buffer capacity, albumin and total protein content as well as concentration of inorganic~     calcium, phosphate and fluoride) are being measured.~      The aim of this study is to investigate whether gender differences in the salivary~     composition correlate with predisposition to erosion.~   "
60040|NCT02780960|"~     The purpose of this study is to evaluate the performance of HPV self-sampling (self-HPV) in~     detecting residual/recurrent disease in women treated by loop electro-surgical excision~     (LEEP) for CIN1+.~   "
60041|NCT02780947|"~     Prophylactic substrate ablation in post-MI patients undergoing defibrillator implantation~     reduces appropriate defibrillator therapies.~   "
60042|NCT02780934|"~     The purpose of this study is to determine whether using a pressure- vs. simple adhesive~     dressing affects the postoperative course and wound healing outcomes following Mohs surgery.~   "
60043|NCT02780921|"~     Perioperative chemotherapy is the gold standard treatment in the resectable and advanced~     gastroesophageal adenocarcinoma. The efficacy of this strategy has been demonstrated in two~     randomized studies (1,2). It reduces tumour size before surgery, treats micrometastases and~     evaluates chemosensitivity. Disease free and overall survival rates were significantly~     improved with perioperative chemotherapy compared to surgery alone. However, the limitation~     of these studies is that among all patients requiring chemotherapy, almost 70% of patients~     will not have the complete sequence. This sequence is defined by the administration of 2 to 4~     cycles before and 2 to 4 cycles after the surgery, according to the protocol. The major cause~     of absence or impossibility of realization of postoperative chemotherapy was the presence of~     postoperative complication, postoperative serious asthenia and impaired nutritional and~     physical status (1,2). Poor physical condition assessed by cardiopulmonary exercise testing,~     reflecting a reduced physiological reserve, is predictive of postoperative complications~     (3,4). A physical training, even during a short period and on a various population, is~     beneficial in improving physical condition, cardiopulmonary function and muscular mass of the~     patient (5-8). A prehabilitation over a 6 week period between surgical consultation and~     surgery decreases postoperative morbidity and the hospital stay in cardiovascular surgery but~     no study has ever been performed in the gastric or oesophageal cancer (7,9).~      Prehabilitation revolves around three axes: 1) a physical training based on initial~     cardiopulmonary exercise testing (VO2peak, anaerobic threshold (AT) and 6-min walk test~     (6MWT)), 3 times by week, supervised by a physical therapist 2) a nutritional care to ensure~     the compliance of the nutrition program and adapt the nutritional management based on protein~     and energy needs and on the level of spontaneous oral intake and 2) a psychological treatment~     by a psychologist to reduce preoperative anxiety. To our knowledge, no study ever focused on~     the gastroesophageal cancer. The benefit of prehabilitation in this cancer may be~     particularly important because 1) this surgery is associated with a high postoperative~     morbidity (40%, especially respiratory) and mortality (5%) 2) the physical and nutritional~     status of these patients is often precarious (cancer cachexia, gastroesophageal obstruction),~     and 3) the need to preoperative chemotherapy declines physical reserves and is associated~     with a lengthening of the time between consultation and surgery of more than 3 months (10).~     Also, the investigators hypothesize that with a physical training, a personalized nutritional~     support and a psychologist management may decrease postoperative complications, increase~     postoperative nutritional status and so, would allow for more patients to receive their full~     cancer treatment. The aim of this study was to evaluate, in gastroesophageal adenocarcinoma,~     the effect of prehabilitation compared to conventional care, the percentage of patients~     reaching the complete oncological treatment decided in a multidisciplinary tumour board.~   "
60044|NCT02780908|"~     This project will consist of two studies, each investigating resting and exercise~     cardio-respiratory responses during exposure to hypoxia in individuals born prematurely and~     individuals born at full term of two different age groups: Kids (10-14 yrs) and Adults (18-22~     yrs).Additional study will be performed on a preterm adult cohort (15 participants) that will~     investigate potential differences between hypobaric and normobaric hypoxia as outlined in the~     following section.~   "
60045|NCT02780895|"~     Implantation of Celavie human stem cells (OK99) is intended to address the underlying~     pathology of the disease by replacing damaged/destroyed cells of the brain, and/or~     stimulating the patient's brain to repair itself.~   "
60048|NCT02780856|"~     This is a prospective, multi-centre clinical study to evaluate the safety and performance of~     the Calcivis Caries Activity Imaging System. Dentists will identify tooth surfaces as either~     sound (inactive) or unsound (active caries lesion present) according to ICDAS staging~     (International Caries Detection and Assessment System). Images of the tooth surface will be~     taken with the Calcivis System immediately before and after application of a disclosing~     solution containing a bioluminescent protein. Presence or absence of elevated luminescence on~     the images will indicate activity / inactivity of the presence or absence of active~     demineralisation on the tooth surfaces.~      The study will be deemed a success if there is 70% agreement and above between:~        1. elevated luminescence and the presence of active caries as determined by the dentists,~          and~        2. absence of luminescence and the determination of a sound tooth surface by the dentists.~   "
60049|NCT02780843|"~     Acute stroke occurs in approximately 13.000 persons every year in Denmark, 10 - 15 % now~     receives intervenous thrombolytic therapy, which remains the most important acute treatment~     in ischaemic stroke. For more than a decade there has been an ongoing discussion if~     Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) were best before~     thrombolysis: Magnetic Resonance Imaging is superior in visualising ischaemia, but~     Computerized Tomography is quicker and more easily applicable.~      In the investigators centre primary imaging in work up of acute stroke during working hours~     will alternate between Computerized Tomography and Magnetic Resonance Imaging days based on a~     fixed calendar for a 24 months period as a quality development project.~      This study is planned to include patients who have acute stroke imagining during this period,~     a total of 600 patients is expected. The investigators will compare door-to-needle time,~     patient safety, quality of imaging, patients' experience, physicians' decision certainty, and~     use of recourses.~   "
60050|NCT02780830|"~     This is a modular study of AZD2014 in combination with novel anti-cancer agents in patients~     with different subtypes of relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL).~     Module 1, a combination with ibrutinib in patients with non-germinal centre B-cell-like~     (non-GCB) DLBCL, will consist of Part A, a Phase I dose-finding arm in which the safety and~     tolerability of the combination will be assessed, and Part B, a Phase II dose-expansion phase~     to assess the efficacy of the combination.~   "
60051|NCT02780817|"~     Inducing a systematic perturbation forces on the hand during arm reaching movement may~     improve adaptation. Error-augmentation (EA) training is relatively new concept in motor~     learning intended to promote the adaptation process. In this study participants will practice~     one session of training on 3D robotic device. Healthy volunteers will be randomly divided~     into two groups: study and control. The study group will carry out the training session with~     EA forces. The control group will carry out the same procedure with null force field. Outcome~     measure are the average size of trajectory error from the straight line and level of exertion~     (borg scale).~   "
60052|NCT02780804|"~     This phase I trial studies the side effects and best dose of entinostat in treating pediatric~     patients with solid tumors that have come back or have not responded to treatment. Entinostat~     may block some of the enzymes needed for cell division and it may help to kill tumor cells.~   "
60053|NCT02780791|"~     The purpose of this study is to determine whether the pelvic wall or the ovary represents a~     better location for the maturation of follicles in the context of ovarian transplantation~     after cryopreservation of ovarian tissue before cytotoxic therapies.~   "
60054|NCT02780778|"~     The purpose of this Phase II, Open-label, single arm, exploratory study is to evaluate the~     efficacy and the safety of Apatinib（500mg/d）with docetaxel (60 mg/m²) in advanced~     Non-squamous Non-small cell lung cancer after failure of first line chemotherapy.~   "
60055|NCT02780765|"~     60 post operative patients who are kept intubated overnight & are spontaneously breathing~     will be either supplied humidified oxygen Heated Humidifier(HH) or conventional mist~     nebulizer.~      Temperature of inspired gas at the Y piece will be measured.~      Sterile water will be used for HH & Mist nebuliser.~      The suctioning of endotracheal tube (ETT) will be done once every 2 hourly by nurse/~     doctor/trained personnel and additional suctioning if required.~   "
60056|NCT02780752|"~     Primary sclerosing cholangitis (PSC) is a chronic inflammatory disease of the biliary ducts~     in the liver resulting in destruction and fibrosis. PSC is associated with increased serum~     levels of hyaluronan (HA), an extracellular matrix polymer known to drive inflammation in~     multiple other tissues and disease models. Inhibition of HA synthesis with oral hymecromone~     has been shown to prevent progression of autoimmunity in several animal models. This is a~     prospective, open-label, single-center, pilot safety study of hymecromone in adults 18 years~     of age or older diagnosed with primary sclerosing cholangitis without evidence of hepatic~     fibrosis. Participants will be treated for 6 months with study drug. Safety and biomarkers of~     response will be monitored during therapy.~   "
60057|NCT02780739|"~     Adaptive reasoning and problem-solving are critical skills that allow for accurate decisions~     to be made based on varying levels of information. In many situations these decisions must be~     made and communicated under stressful, time-sensitive conditions. In such contexts, an~     ability to apply inductive and deductive reasoning to complex, ambiguous, and/or novel~     problems is critical. The objective of the INSIGHT project is to establish a comprehensive~     and rigorous brain training protocol to significantly improve adaptive reasoning and problem~     solving. We will examine a variety of interventions (cognitive training, physical fitness~     training, physiological stimulation, , and combinations thereof) to assess their ability to~     improve adaptive reasoning and problem solving abilities. Multimodal interventions are~     hypothesized to act synergistically to significantly enhance fluid intelligence (Gf) and~     underlying brain structure and function.~   "
60058|NCT02780726|"~     The objective of this study is to evaluate the safety and efficacy of ASP1517 in peritoneal~     dialysis chronic kidney disease patients with anemia.~   "
60059|NCT02780713|"~     This is a phase 1 open label single centre study of AZD9496 administered orally in healthy~     volunteers. The study design involves single administration of different forms, formulations~     and doses of AZD9496. The study is designed to investigate these different AZD9496 variants.~     The study will evaluate the pharmacokinetic profiles and the safety and tolerability of the~     different forms, formulations and doses of AZD9496~      This is a fixed sequence study with 5-sequential treatment periods in healthy volunteers.~     Each volunteer will receive 5 single doses of AZD9496 in different forms, formulations and~     doses.~   "
60061|NCT02780687|"~     The purpose of this trial is to assess the anti-tumour activity and safety of afatinib~     monotherapy in patients with urothelial tract carcinoma carrying ERBB2 or ERBB3 mutations or~     ERBB2 amplifications (Cohort A), and EGFR amplification positive tumours (Cohort B),~     progressing despite previous platinum based chemotherapy, and thereby to improve their~     prognosis.~      The antitumour activity of afatinib monotherapy in these patients will be assessed by~     progression free survival rate at 6 months (PFS6). This will be the primary endpoint of the~     trial. A key secondary endpoint will also be defined, the objective response rate (ORR).~   "
60062|NCT02780674|"~     To evaluate the safety and tolerability of escalating, single subcutaneous doses of MEDI7734~     in adult subjects with type I interferon-mediated autoimmune diseases.~   "
60063|NCT02780661|"~     This method development study will be a two treatment arm, randomized, cross over study in a~     population with edentulous upper arch restored with a maxillary complete denture. The lower~     may be a partial or full edentulous mandibular arch that may be restored with a stable~     complete, partial or implant supported denture.~   "
60064|NCT02780648|"~     This is a single center, single arm unblinded prospective study of the safety of pancreatic~     stereotactic body radiation therapy (SBRT) in patients with unresectable, borderline~     resectable, or recurrent pancreatic/periampullary cancers who have previously undergone~     treatment with chemotherapy, surgery, photodynamic therapy, conventionally fractionated~     radiation treatment, or any combination of these therapies.~      Primary Objective~      • To estimate rates of acute (within 3 months of treatment) grade 3 or greater~     gastrointestinal and hematologic toxicity in patients treated with Linac-based SBRT for~     pancreatic or periampullary cancers who have previously received other treatment.~      Secondary Objectives~        -  To estimate rates of late (> 3 months after treatment) grade 2 gastritis, enteritis,~          fistula, and ulcer, or any other grade 3 or greater gastrointestinal toxicity in~          patients treated with Linac-based SBRT for pancreatic or periampullary cancers~        -  To estimate rates of local progression, overall survival, metastasis-free survival, and~          progression-free survival in patients with pancreatic or periampullary cancers treated~          with fractionated Linac-based SBRT.~        -  To evaluate the ability of Linac-based SBRT to provide pain control in patients with~          pain related to a pancreatic or periampullary tumor.~        -  To evaluate quality of life in patients undergoing treatment with Linac-based SBRT for~          pancreatic or periampullary cancers.~   "
60065|NCT02780635|"~     In layperson's language state the purpose of the study in 3-5 sentences.~      Previous research has demonstrated that intimate partners can positively influence those with~     PTSD to seek treatment. The investigators have preliminary evidence to demonstrate that~     mobile apps, such as PTSD Coach can be helpful for those with PTSD, and the current study~     will provide Veterans with PTSD and their partners with a mobile app designed to promote~     engagement with evidence-based treatments for PTSD. The purpose of this PILOT study is to~     evaluate methods for delivering a couples-based intervention to reduce PTSD symptoms and~     improve relationship quality in Veterans and their intimate partners.~      b) State what the Investigator(s) hope to learn from the study. Include an assessment of the~     importance of this new knowledge.~      Understanding ways to improve the public health impact of public-facing, evidence-based~     mobile apps is critical. This study will test a low-cost, high-touch approach to improving~     the outcomes associated with use of the PTSD Coach and PTSD Family Coach mobile apps,which~     are already available to the general public and used by over 55,000 new users per year.This~     study will test whether the involvement of an intimate partner in the use of a mobile app for~     PTSD will result in changes in how the mobile apps are used and in relationship quality and~     PTSD symptoms over time. Additionally, this study will test whether the addition of a~     discussion board can improve engagement with the apps and/or outcomes. The study will also~     provide useful qualitative data that can inform the development of subsequent dyadic~     interventions using mobile technologies.~      c) Explain why human subjects must be used for this project. (i.e. purpose of study is to~     test efficacy of investigational device in individuals with specific condition; purpose of~     study is to examine specific behavioral traits in humans in classroom or other environment)~      The purpose of this study is to evaluate how Veterans and their partners interact with~     evidence-based mobile apps for improving PTSD symptoms.~   "
60066|NCT02780622|"~     This is an open-label, randomized, 2-period crossover study, to evaluate the~     pharmacokinetics, pharmacodynamics, safety and tolerability of warfarin in combination with~     Tamiflu (oseltamivir) in participants stabilized on warfarin. Participants will be randomized~     to receive either their warfarin followed oseltamivir and warfarin, or by oseltamivir and~     warfarin followed by warfarin. The treatment periods will be separated by a washout period of~     at least 4 days. Participants will continue receiving warfarin once daily at a prescribed~     usual dose throughout the study.~   "
60067|NCT02780609|"~     Phase I: The primary purpose of this study phase is to determine the best dose also referred~     to as the maximum tolerated dose (MTD) of Selinexor when used in combination with high-dose~     melphalan as a conditioning regimen for hematopoietic cell transplant.~      Phase II: The primary purpose of this study phase is to assess the complete response (CR)~     conversion rate.~   "
60068|NCT02780596|"~     This study aims to:~        1. identify which single item or combination of two items perform best in identifying~          problematic infant night wakings and~        2. describe current practices by pediatricians in addressing problematic infant night~          wakings.~      Using a novel computer decision support system in several primary care clinics, caregivers~     accompanying their child to a health visit will be randomly assigned to receive two of five~     items assessing night wakings and/or sleep problems, followed by a validated questionnaire~     for infant night wakings. If caregiver responses to the items suggest a possible sleep~     problem, pediatricians will receive a prompt in the electronic health record identifying a~     possible infant sleep problem. A sub-sample of caregivers will then be interviewed regarding~     the content of the visit that day.~   "
60069|NCT02780583|"~     The primary purpose of this study is to determine whether giving injections of anakinra is a~     safe and well tolerated treatment to give as an adjunct to standard prescribed treatment for~     patients who are admitted to the hospital with signs of severe inflammation (macrophage~     activation syndrome) that is potentially life-threatening. Anakinra is a commercially~     available product (Kineret™) approved for the treatment of rheumatoid arthritis; it is a~     replica of a naturally occurring protein called Il-1 receptor antagonist (IL-1ra), made by~     humans to inhibit and regulate the action of interleukin-1 (IL-1). IL-1 is a mediator of~     inflammation that when generated in excess amounts by immune system cells can result in~     severe dysfunction of multiple organs that can be life-threatening. The specific primary~     objectives of the study are to determine if giving anakinra results in no increased infection~     complications or mortality. Additional data will be collected to determine whether anakinra~     administration results in any other unanticipated side effects in this setting, and the~     effects of anakinra administration on inflammation markers, the overall dose of steroids~     required to treat the inflammation, and the length of hospital stay.~   "
72746|NCT02614755|"~     The primary objective of this observational study is to determine performance characteristics~     and usability of Lumosity and the Brain Performance Test in a group of older adult~     volunteers.~   "
60070|NCT02780570|"~     Guillain-Barré syndrome (GBS) is the commonest form of acute flaccid paralysis and the~     incidence is high in low-income countries. In Bangladesh, most GBS patients are poor.~     Therefore patients cannot afford expensive specific treatments like intravenous~     immunoglobulin (IVIg) or plasmapheresis (PE) in part explaining the high mortality and~     disability compared to treated patients in high-income countries. Added difficulty in~     traditional PE is its unavailability and specialized device and manpower dependency. Most~     research in GBS has been conducted in high-income countries, largely in patients with a~     demyelinating form of GBS. Axonal form of GBS is common in low-income and Asian countries~     which has a different pathogenesis, clinical course and outcome than the demyelinating form.~     Very few therapeutic studies have been conducted in low-income countries due to expensive~     existing modalities of treatment. Here, the investigators propose SVPE as a treatment for GBS~     in patients from low-income countries. SVPE is relatively cheap, can be done at the bedside~     without any special device or electricity and eventually is expected to help poor severely~     affected GBS patients in underdeveloped and developing countries. The main outcomes will be~     the safety and feasibility of SVPE since this is yet to be established in the resource~     limited settings. To be able to evaluate the safety of SVPE, additional information will be~     acquired about the frequency of complications in non-GBS patients with a central line,~     treated during the same time period at the same study facility as the GBS patients. Severe~     sepsis due to central line associated blood stream infection and deep venous thrombosis in~     the limb where the central venous catheter will be inserted during or following the SVPE~     procedure, will be defined as severe adverse effect (SAE) and will be considered as primary~     outcome measure for safety. Blood, cerebrospinal fluid and other relevant biological~     specimens will be analysed for diagnosis and screening for infections. In addition clinical~     and neurological outcome assessment will be monitored until discharge of the patient from the~     hospital and up to four weeks since study entry. Confirmation of feasibility and safety, will~     eventually lead to a randomized control trial in future with a primary focus on the clinical~     efficacy of SVPE for the treatment of GBS in developing countries as an alternative for the~     conventional treatment with IVIg or PE.~   "
60071|NCT02780557|"~     The aim of this project is to test whether giving parents advice about book reading is~     effective in promoting language learning for infants from a range of socio-economic~     backgrounds.~   "
60072|NCT02780544|"~     Retinopathy of prematurity (ROP) is a feared complication of premature birth. If discovered~     in time, the disease can be treated, and impaired vision or blindness can be reduced.~     Premature infants are therefore examined regularly after birth. However, the examination is~     painful and stressful for the infant. Painful experiences might lead to a pathological stress~     response later in life and should therefore be prevented.~      In this study skin-to-skin contact with a parent is tested for relief of pain and stress in~     preterm infants being examined for retinopathy of prematurity.~   "
60073|NCT02780531|"~     The purpose of this study is to identify genetic or other factors in the subjects blood that~     may predispose them to getting a particular disease or tell researchers how the disease will~     behave, for example how fast it will progress or what areas of the body might be affected. A~     second goal is to relate such factors to how such a condition affects the subjects clinically~     as well as how it affects the electrical functions of nerves and muscles.~   "
60074|NCT02780518|"~     Optiflow high flow nasal cannula (HFNC) oxygenation is a technique to provide oxygen to~     patients when they are paralysed under general anaesthesia. Their lungs are not moving, but~     the high flow allows oxygen to travel into their lungs. This is called 'apnoeic ventilation'.~     The investigators will be using this for patients undergoing surgery for their throat.~   "
60075|NCT02780505|"~     Among patients with chronic kidney disease (CKD), there is association between anemia and~     increased chance of mortality mainly because of cardiovascular diseases and stroke, risk of~     hospitalization, and death prevalence in predialysis patients. Vitamin C plays an important~     role in iron metabolism and application for red blood cell formation. Infusion of ascorbate~     supplementation can reduce oxidative stress among hemodialysis patients. This study aimed to~     assess the effect of vitamin C on patients with continuous ambulatory peritoneal dialysis~     (CAPD).~   "
60076|NCT02780492|"~     Novel emerging therapies for Duchenne Muscular Dystrophy (DMD) require a deeper understanding~     of DMD natural history. This study aim to assess the natural history of DMD through a~     composite assessment tool capable of capturing disease progression linking ambulant and~     non-ambulant phases of the disease.~   "
60077|NCT02780479|"~     Asthma is the most common chronic disease of children. A short (3-5 day) course of a~     short-acting steroid such as Prednisone or Prednisolone has long been the standard of care~     for asthma exacerbation. Dexamethasone efficacy in asthma exacerbation has been studied in~     the outpatient setting and was found to be as effective as Prednisone. Dexamethasone has the~     advantage of shorter course, more compliance, and more tolerable. This has led many emergency~     departments to provide a 1-2 dose course of Dexamethasone on discharge. Thus, many inpatients~     have received a first dose of Dexamethasone prior to reaching the inpatient unit, leading to~     confusion about the best plan for these patients. Many hospitalist pediatricians continue to~     give a 5-day total course with Prednisone, but some patients have begun to receive a second~     dose of Dexamethasone 24 hours after the first dose. To our knowledge, no studies have been~     done to compare the efficacy of these two protocols in pediatric patients requiring~     hospitalization. The hypothesis is that a second dose of Dexamethasone is as effective as~     four additional days of Prednisone in hospitalized children with asthma exacerbation. This is~     an open label, randomized control study comparing these treatments in children age 2-18~     hospitalized with asthma exacerbation who have received a first dose of Dexamethasone.~   "
60078|NCT02780466|"~     Septic shock is common in intensive care and its mortality remains high. While new treatments~     have not improved survival, optimization of known and widely used techniques has allowed~     reduction in mortality. Thus improving care given to patients starts with making better use~     of existing resuscitation techniques. Among these practices, mechanical ventilation is~     widespread in the management of patients with septic shock. In large studies published in~     recent years in Europe and North America, 40 to 85% of patients receive invasive mechanical~     ventilation. It therefore appears that a significant proportion of patients are never~     intubated during treatment and management of their septic shock. There is no specific~     recommendation from critical care societies concerning mechanical ventilation in the~     treatment of septic shock. Apart from indisputable situations such as impaired consciousness~     or acute respiratoire distress, the decision whether to ventilate mechanically or not is left~     to the discretion of the physician.~      The aim of this study is to analyze intubation practice in septic shock patients and its~     impact on 28-day survival.~      This multicentric and observational study will be conducted in 30 French ICUs.~   "
60079|NCT02780453|"~     Laparotomy wounds are associated with high rates of surgical site infections (SSI). The~     effect of prophylactic negative pressure dressing of closed incisional wounds on SSI rates is~     inconclusive.~   "
60296|NCT02777619|"~     The purpose of this study is to determine pharmacodynamic interactions of propofol and~     dexmedetomidine,exploring the effect of dexmedetomidine on propofol unconsciousness median~     effective concentration (EC50).~   "
60080|NCT02780440|"~     The purpose of this randomized controlled study is to~        1. Examine the feasibility of a home Mirror therapy (MT) program in the NYC metropolitan~          area;~        2. Evaluate the effectiveness of home MT versus traditional home exercise program; and~        3. Evaluate the superiority of unimanual or bimanual MT intervention protocols for chronic~          stroke subjects with moderate hand deficits. Subjects from occupational therapy at the~          Ambulatory Care Center of NYU Langone Center with a diagnosis of cerebral vascular~          accident (CVA) or stroke will be divided into three (3) groups:~             -  Control Group subjects will participate in standard occupational therapy~               rehabilitation protocol plus a traditional home based exercise program.~             -  Experimental group 1 subjects will participate in standard rehabilitation protocol~               plus unimanual home based mirror therapy program~             -  Experimental group 2 subjects will participate in standard rehabilitation protocol~               plus bimanual home based mirror therapy program.~   "
60081|NCT02780427|"~     The median effective dose (ED50) and ED95 of intranasal dexmedetomidine as a single bolus~     have not been described for sedation in children undergoing transthoracic echocardiography~     (TEE) study. This information is important to compare agents and to determine the most~     effective sedative dose. The investigators performed a two-stage study to determine the ED50~     and the ED95 of intranasal dexmedetomidine to investigate age-related differences in~     participants undergoing transthoracic echocardiography study.~   "
60082|NCT02780414|"~     Preeclampsia (Pre-E) is a hypertensive disease of pregnancy with multi-system involvement~     that usually occurs in the second half of pregnancy. Pre-E occurs in 5% to 7% of U.S.~     pregnancies, and is the third-leading cause of U.S. maternal death. Improvements to the~     current diagnostic paradigm have been evaluated. However, no stand-alone diagnostic method~     has emerged that more accurately identifies women at risk for preeclampsia, warranting~     improvements in diagnosing Pre-E.~      This sample collection study will obtain serum and urine samples from pregnant women who~     present with clinical signs, symptoms, or conditions contributing to the suspicion of Pre-E.~     Samples will be used to evaluate and validate the performance of an assay intended to aid in~     assessing the risk of Pre-E.~   "
60083|NCT02780401|"~     This phase I trial studies the side effects and best dose of a vaccine therapy in preventing~     cancer from coming back in patients with non-metastatic, node positive, human epidermal~     growth factor receptor (HER)2 negative breast cancer in which all signs and symptoms have~     disappeared. Vaccines made from deoxyribonucleic acid (DNA) may help the body build an~     effective immune response to kill tumor cells. Giving multiple vaccinations may make a~     stronger immune response and prevent or delay the return of cancer.~   "
60084|NCT02780388|"~     The purpose of this study is to determine whether MEDI4920 is safe and tolerable in patients~     with adult-onset rheumatoid arthritis.~   "
60085|NCT02780375|"~     Peripheral blood samples will be taken with informed consent from radiotherapy patients~     undergoing standard radiotherapy at The Royal Marsden before and during treatment for breast,~     lung, gastrointestinal and genitourinary tumours. Responses from panels of up to 800 coding~     and non-coding RNAs will be assessed in the samples using the nCounter system. Candidate~     genes identified by Public Health England, Columbia University and/or in the literature as~     being specific to radiation responses will be included, together with genes relevant to~     systemic inflammatory responses, to identify transcriptional responses for a range of doses~     and exposures on an inter-individual basis. Data will be analysed using existing and new~     statistical tools focused on count data modelling. The intended outcome is identification of~     a radiation specific panel of genes to inform individual radiation responses and if the~     results are favourable, a large scale follow up to this proposed pilot is expected in due~     course.~   "
60086|NCT02780362|"~     An open label randomized, single dose, two-way crossover bioequivalence study to determine~     the bioequivalence of Daclatasvir from Prodactariv 60 mg F.C.T (International Drug Agency for~     Pharmaceutical Industry (IDI), Egypt) and Clatazev 60 mg F.C.T (Bristol-Myers Squibb Pharma,~     UK) in Healthy Human Volunteers Under Fasting Condition~   "
60087|NCT02780349|"~     Demonstrate the safety and performance of the WIRION™ EPS in subjects undergoing lower~     extremity atherectomy for the treatment of Peripheral Arterial Disease (PAD)~   "
60088|NCT02780336|"~     The aim of this study is to develop new rating scales to help diagnose and measure the~     severity of blepharospasm. This is a condition involving a lot of blinking and spasms of eye~     closure that people can't control. This study will also test some video software to see if it~     can help diagnose people or tell the severity of disease using only a video recording of an~     exam. There is an additional plan to create an educational video to teach others the proper~     use of the scale and video software.~   "
60089|NCT02780323|"~     This Phase IV clinical study is to Compare the Efficacy and Safety of CELBESTA® and CELEBREX®~     in Rheumatoid Arthritis Patients~   "
60090|NCT02780310|"~     The purpose of this study is to find out what effects, good and/or bad, the drug lenvatinib~     has on the patient and on adenoid cystic carcinoma. This type of cancer study is called a~     phase II study. Researchers hope to learn if the study drug will shrink the cancer by at~     least one-quarter compared to its present size.~      Lenvatinib is an oral medication that can interfere with cancer cell growth and reduce the~     growth of blood vessels around tumors. This study will help find out if lenvatinib is a~     useful drug for treating patients with adenoid cystic carcinomas.~   "
60091|NCT02780297|"~     The purpose of this study is to determine the natural history of the hereditary forms of~     nephrolithiasis and chronic kidney disease (CKD), primary hyperoxaluria (PH), cystinuria,~     Dent disease and adenine phosphoribosyltransferase deficiency (APRTd) and acquired enteric~     hyperoxaluria (EH). The investigator will measure blood and urinary markers of inflammation~     and determine relationship to the disease course. Cross-comparisons among the disorders will~     allow us to better evaluate mechanisms of renal dysfunction in these disorders.~   "
60092|NCT02780284|"~     The purpose of this study has 2 aims:~      Aim 1: To demonstrate the feasibility of recruiting and retaining adults at high risk of~     colorectal cancer to a physical activity intervention trial. Investigators hypothesize that~     it will be possible to recruit and retain this patient population to a physical activity~     intervention trial.~      Aim 2: To demonstrate the feasibility of collecting, processing, storing stool samples and~     analyzing the gut microbiome data. Investigators hypothesize that all of these steps are~     feasible.~   "
60093|NCT02780271|"~     We will conduct a 2x2 factorial randomized controlled trial to test the separate and~     synergistic effects of an in-person hands-on dietary and physical activity change curriculum~     (i.e., Mi Vida Saludable program) and e-communication strategies (text messaging, emailed~     newsletters and an interactive website) on changing dietary and physical activity behaviors~     among a diverse population of Latina breast cancer survivors who have completed breast cancer~     treatment. Participants will be evenly randomized to 4 arms: in-person education alone,~     e-communication alone, in-person education plus e-communication, or control.~   "
60094|NCT02780258|"~     To evaluate the safety and efficacy of Restylane Silk for photoaged thinned hands~   "
60095|NCT02780245|"~     This study aims to compare role of a prophylactic predefined intravenous Tranexamic Acid dose~     versus intraoperative Uterine Cooling in reducing blood loss and incidence of postpartum~     hemorrhage at secondary CS.~   "
60096|NCT02780232|"~     Major depression is a highly prevalent and severe mental disease. Interventions based on~     information and communication technologies (ICTs) generate innovative opportunities to~     prevent and to intervene early the depression in adolescents. In Colombia, there are few~     preventive mental health interventions scientifically oriented and seeking to demonstrate~     efficacy in context.~      The purpose of this study is to determine whether an internet-based program is effective to~     prevent and to intervene early the depression in adolescents between 13 and 19 years of age~     in 8 schools of the Antioquia Region, Colombia .~      Study design: A cluster-randomized clinical trial will be carried out with 600 adolescents.~     The efficacy, adherence, and acceptability of the internet-based program will be evaluated. A~     single-blind randomized controlled trial will be conducted with two arms, the intervention~     arm (n=300), which will receive an internet-based program for depression, and the TAU~     (Treatment As Usual) arm (n=300).~   "
60097|NCT02780219|"~     For this study a resistance bout will be performed in order to promote the robust response of~     protein synthesis. Type II muscle fibers often exhibit more atrophy than type I fibers in~     COPD subjects therefore specifically targeting them in an exercise protocol could have more~     beneficial outcome for these individuals.~   "
60098|NCT02780206|"~     Understanding how foods and nutrients are digested, absorbed and metabolized when weight is~     stable and during weight loss induced by very low calorie diet procedure using the~     technologies of genomics, transcriptomics, proteomics, metabolomics and fluxomics (omics)~     will enable generation of new hypotheses that could explain the inter-individual differences~     in weight loss and could lead to optimization and individualization of therapies designed to~     lose weight.~   "
60099|NCT02780193|"~     The purpose of this study is to provide intravenous omega-3 fatty acids and monitor tolerance~     in subjects with prolonged parenteral nutrition dependence and parenteral~     nutrition-associated cholestasis through expanded access.~   "
60100|NCT02780180|"~     Heart Failure (HF) a common clinical condition characterized by either by a heart that does~     not pump sufficiently or becomes stiff. A variety of mechanisms contribute to progressive~     cardiac remodeling and dysfunction.~      A new therapeutic approaches by preventing activation of the brain neuromodulatory pathway,~     may lead to improve HF.~      QCG001 is a prodrug of EC33, a aminopeptidase A (APA) inhibitor. QCG001 has been shown to be~     an antihypertensive agent in animal models.~      This study investigates the safety and efficacy of QGC001 in HF patients.~   "
60101|NCT02780167|"~     Study B7451006 is a Phase 2b POC study which is planned to assess four PF 04965842 once daily~     (QD) doses (10, 30, 100, 200 mg) relative to placebo over 12 weeks to characterize the~     efficacy and safety of PF 04965842 in subjects with moderate to severe AD. The objectives of~     the study are to demonstrate the efficacy of PF 04965842 by showing improvement in disease~     severity in patients with moderate to severe AD as measured by the Investigator's Global~     Assessment (IGA) and Eczema Area and Severity Index (EASI) scores, and safety to support~     further clinical development of PF 04965842.~   "
60102|NCT02780154|"~     This is a single center, randomized and controlled human study to optimize controlled human~     malaria infection (CHMI) administered by direct venous inoculation (DVI). 36 healthy adults~     aged between 18 and 45 years, will be randomized to one of five groups and will be inoculated~     with PfSPZ Challenge DVI. Participation duration is estimated to be 2 months, while the study~     duration is planned to be 4 months. The primary objective of this study is to assess the~     safety and reactogenicity of PfSPZ Challenge administered by DVI using 7G8 and NF54 P.~     falciparum strains.~   "
60103|NCT02780141|"~     The objective of this study is to evaluate the safety and efficacy of ASP1517 in ESA-naive~     hemodialysis chronic kidney disease patients with anemia.~   "
60104|NCT02780128|"~     The purpose of this research study is to match genomic aberrations in tumor cells at time of~     relapse to rationally designed combinations of molecularly targeted agents. This study will~     be done in two parts:~      Part I: Tumor will be accessed at study entry via a biopsy and subjected to deep sequencing~     to identify protocol-specified biomarkers for therapy assignment.~      Part II: If the tumor contains a genetic change defined by the study as being actionable, and~     other criteria are met, participants will be assigned to therapy based upon the genetic~     changes identified in the tumor biopsy.~   "
60105|NCT02780115|"~     This is a safety, efficacy and pharmacokinetics study of the fixed combination of AGN-199201~     and AGN-190584 in participants with presbyopia (inability to focus on items close-up).~   "
60106|NCT02780102|"~     The investigators administered a randomized controlled trial (RCT) through random assignment~     of children with ADHD into three different groups to compare the effects of cognitive-motor~     rehabilitation, immediate release methylphenidate, and an active control on the executive~     functioning, learning, and behavioral symptoms of children with ADHD.~   "
60107|NCT02780089|"~     This study evaluates the different patterns of care for patients who have unresectable or~     metastatic melanoma. The dosing, duration, regimen, indication, and treatments will be~     observed. The survival rate of these patients will also be observed.~   "
60225|NCT02778542|"~     The goal of this pilot study is to test different approaches to monitor medication adherence~     in hypertension patients, leveraging the NIH-funded Way to Health platform. Patients with~     poor blood pressure control will be recruited from the University of Pennsylvania Health~     System practices and offered remote monitoring with electronic pill bottles, bidirectional~     text messaging or usual care. Our aim is to analyze and compare the effects of remote~     monitoring with electronic pill bottles versus bidirectional messaging on blood pressure~     reduction after 4 months.~   "
60108|NCT02780076|"~     The survivors after hip fracture often report severe pain and loss of physical functioning.~     The poor outcomes cause negative impact on the person's physical functioning and quality of~     life and put a financial burden on society. It is important to continue and progress the~     functional training that already started at the hospital, while the patients are transferred~     to short-term stays in a nursing home before they are returning to home. The aim presently is~     to examine the effects of a functional training program by a RCT design, initiated by the~     physiotherapist and performed by the nurses, on physical functioning while the patients are~     at short term stays in primary health care.~   "
60109|NCT02780063|"~     Prior to cataract surgery the lens must be calculated to appropriately fit a patient for the~     intraocular lens implant. Lenstar is an optical biometer that calculates the axial length,~     keratometry, lens thickness, pupillometry, and anterior chamber depth. Dilation drops are~     routinely used in eye exams in addition to pre-cataract surgery. The dilation drops include~     Tropicamide 1%, and Phenylephrine 2.5%. The Tropicamide achieves the dilation of the pupil~     which causes an anterior rotation of the ciliary body, which may affect the Lenstar~     measurements. This study is to determine if dilating medications affect the lens power~     prediction for emmetropia by the Lenstar biometer. Prior to dilation, Lenstar biometry will~     be performed on each eye. Patients will receive dilation medication and after waiting 20~     minutes Lenstar biometry will be performed on each eye. Dilation and measurement with Lenstar~     will be done as standard of care. Measurements and calculations from before and after will be~     compared.~   "
60110|NCT02780050|"~     Chest compression, a key component of cardiopulmonary resuscitation (CPR), has a major role~     for survival of cardiac arrest patients. According to 2015 American heart association (AHA)~     guideline, rescuers provide high quality CPR to adult cardiac arrest patients including 5 to~     6 cm depth and 100 to 120 beat per minute rate chest compression.~      However, in CPR situation, chest compression depth and rate vary according to provider's~     muscle strength. In other words, the individual difference of the degree of physical activity~     will make the different result for CPR. So, the investigators hypothesize that the core~     muscles activation using physical fitness improves the quality of chest compression and the~     quality of CPR, eventually.~   "
60111|NCT02780037|"~     This study examines the short- and long-term-effects of different repeated frames in which an~     exercise program is offered on behavior (i.e., frequency of exercise) and motivation (i.e.,~     autonomous/controlled) in older people (65+). The frames are manipulated experimentally as~     either prevention focused (e.g., to prevent worse health), promotion focused (e.g., to gain~     better health) or neutral (control condition).~   "
60112|NCT02780024|"~     Glioblastoma Multiforme is one of the most common, and unfortunately one of the most~     aggressive brain tumors in adults with most of the patients recurring and dying of the~     disease with a median survival of 16 months from diagnosis.~      Current treatment for patients with newly diagnosed Glioblastoma Multiforme (GBM) is safe~     maximal surgical resection followed by concomitant conventional Radiotherapy (RT) delivered~     in 6 weeks + Temozolomide (TMZ) followed by TMZ for 6 to 12 cycles.~      Recent scientific research has shown that Metformin, a common drug used to treat diabetes~     mellitus, may improve the results of the treatment in patients with a variety of cancers,~     such as breast, colon, and prostate cancer. Metformin is an attractive and safe medication to~     be used in this group of patients because of its very low toxicity.~      In our center the investigators have been using TMZ for 2 weeks prior to a short course (4~     weeks) of RT which equivalent to the standard RT of 6 weeks. Temozolomide is used 2 weeks~     before RT + TMZ, and this is followed by the 6 to 12 cycles of TMZ. Our results are quiet~     encouraging with a median survival of 20 months, and acceptable toxicity.~   "
60113|NCT02780011|"~     This is an open label phase I trial designed to evaluate the maximum tolerated dose,~     dose-limiting toxicities, pharmacokinetics, and activity of the combination of alsertib~     (MLN8237) and brentuximab vedotin in patients with relapsed/refractory CD30-positive~     lymphomas and solid malignancies. Cohorts of 3-6 patients will receive escalating or~     de-escalating doses of MLN8237 based on a 3 + 3 design.~   "
60114|NCT02779998|"~     Acute respiratory failure is frequent during rhythmology procedure under light sedation in~     high risks selected patients. Non invasive ventilation (NIV) is recommended for acute~     cardiogenic pulmonary oedema and sleep apnea. The investigators will perform a monocentric,~     prospective, randomized controlled trial to compare the efficacy of NIV which associated~     pressure support ventilation (PSV: 5 to 15 cmH2O) and positive end expiratory pressure (PEEP:~     5 to 10 cmH2O) with standard oxygen therapy in prevention of peroperative respiratory event.~     Our hypothesis is that peroperative use of NIV should reduce the incidence of apnea and~     hypoxia during procedure in rhythmology under light sedation.~   "
60115|NCT02779985|"~     Effects of foods or food substances on energy expenditure are of particular interest, because~     of the increasing prevalence of obesity and its consequent metabolic diseases like type II~     diabetes and fatty liver disease, all risk factors for the development of cardiovascular~     diseases (CVDs). Recently, the Goji berry (Lycium Barbarum, wolfberry) was introduced into~     the Western diet. L. Barbarum originates from Asia, where it is used to improve the health of~     several organs. Although L. Barbarum is promoted as a super food with many beneficial~     effects, consistent scientific evidence for these effects is lacking. In one study, it was~     found that short-term intake of L. Barbarum polysaccharides - equal to 150 g of fresh berries~     - increased postprandial oxygen consumption. This indicates that L. Barbarum might exert~     beneficial effects on energy expenditure. Furthermore, long-term intervention trials have~     shown beneficial effects of L. Barbarum on lipid and glucose metabolism in mice and type II~     diabetic patients and on inflammatory status in healthy elderly. Altogether, L. Barbarum has~     the potential to be used as a functional food to increase metabolic health, but detailed~     information on the postprandial effects of L. Barbarum is missing. We therefore propose this~     double-blinded, randomized, placebo controlled intervention trial to investigate the effect~     of a single dose of L. Barbarum on postprandial energy expenditure substrate oxidation,~     metabolic flexibility, lipid and glucose metabolism and inflammatory markers.~   "
60245|NCT02778282|"~     The goal of the MySafeRx study is to evaluate the feasibility, acceptability, and usability~     of a novel platform that integrates text messaging reminders, secure electronic pill~     organizers, and daily remote brief motivational recovery support visits with a standardized~     protocol for supervised self- administration of buprenorphine via videoconferencing.~   "
60116|NCT02779972|"~     Aging is associated with numerous changes and adaptations in the cardiovascular system.~     Vascular and ventricular wall thickness increase, whereas arterial compliance, endothelial~     function, and ventricular contractility decline. The decline in cardiac function with~     advancing age is typically seen in parallel to reduced physical activity, and it has been~     proposed that lifelong exercise training might attenuate the effects of aging on the heart.~      The cardiovascular system undergoes several age-related changes. For most healthy older~     individuals, the heart generally functions well under resting conditions. Structural and~     physiological changes tend to result in diminished exercise tolerance. However, increasingly~     it has been shown that even some of these changes are more a result of a sedentary lifestyle~     than an age-related phenomenon. Most elderly people tend to become less physically active. It~     is difficult to separate changes intrinsic to the aging process from those arising as a~     result of a sedentary lifestyle.~   "
60117|NCT02779959|"~     Headache is a common presenting complaint to the emergency department accounting for 1-2% of~     patient visits. Of these headaches, approximately 90% are migraine, tension headache, or~     combined presentations. The most commonly used migraine therapy in the ED is intravenous~     prochlorperazine, but its administration requires close nursing observation, a bed, and the~     insertion of an intravenous catheter. Buccal prochlorperazine represents an alternative form~     of delivery that enables rapid achievement of therapeutic blood levels and may lead to~     symptom resolution. In a randomized, controlled, prospective study,the investigators plan to~     assess the efficacy of buccal versus intravenous prochlorperazine for the initial emergency~     department treatment of migraine headaches.~   "
60118|NCT02779946|"~     Background: Non-alcoholic fatty liver disease (NAFLD) is the hepatic manifestation of the~     metabolic syndrome, which is one of the major risk factors of coronary heart disease (CHD).~     CHD is the most important manifestation of atherosclerosis, because of its immense morbidity~     and mortality. Transient elastography (TE, Fibroscan®) including the currently developed~     controlled attenuation parameter (CAP) is a non-invasive method for evaluation of liver~     fibrosis and steatosis, which is already implemented in routine care of patients with NAFLD.~     Hypothesis: The use of TE with CAP as screening for NAFLD might be an easy tool for risk~     assessment for CHD. Methods: Patients scheduled for routine coronary angiography will be~     screened for manifestation of NAFLD by TE including CAP, conventional ultrasound, clinical~     and laboratory parameters. Patients will be stratified for the presence of CHD based on the~     angiography results and correlation analysis with liver fat content will be performed. NFALD~     screening will be validated in a subgroup by MR-based measurements.~   "
60119|NCT02779933|"~     A retrospective, observational study compiled data from all consecutively admitted patients~     older than 18 years at ICU University Hospital in Olomouc in the period from 1 January 2011~     to 31 December 2015 who fulfilled the criteria of HAP. The aim was to determine the severity~     of the specific risk factors of early and late HAP. Risk factors were divided into factors~     from the patient and from the hospitalization. Furthermore, an assessment of their~     relationship to mortality.~   "
60120|NCT02779920|"~     Gastroparesis is a common chronic condition, disabling the limited therapeutic resources~     justifying the exploration of new therapeutic possibilities.~      By analogy to the technique of Per Oral Endoscopic Myotomy (POEM), we believe that myotomy~     pyloric muscle (POP = Per Oral Pyloromyotomy) endoscopically could become a treatment of~     choice in the refractory gastroparesis with drug treatments by attacking the pyloric obstacle~     often spastic that counteracts an effective gastric emptying.~   "
60121|NCT02779907|"~     This community-based cross-sectional survey will estimate the frequency and risk factors of~     Chronic Suppurative Otitis Media and Hearing Impairment in Children ages 4-6 years in the~     Chikwawa District. These data will be useful for service planning, disease prevention efforts~     and to guide future research in this field.~   "
60122|NCT02779894|"~     This project develops a new form of management of subjects with suspected SAHS and different~     sleep disorders by applying Information and communications technologies (ICT).~   "
60123|NCT02779881|"~     Epigenetic mechanisms have been implicated in the pathogenesis of food allergy. The~     investigators previously demonstrated that tolerance acquisition in children with~     Immunoglobulin E- (IgE) mediated cow's milk allergy (CMA) is driven by epigenetic modulation~     of the Th1 and Th2 cytokine genes. A regulatory T cell (Treg) suppressive phenotype,~     characterized by stable expression of the transcription factor Forkhead box Protein 3~     (FoxP3), plays a pivotal role in food tolerance. FoxP3 mRNA expression is lower in children~     with atopic asthma or IgE-mediated food allergy than in healthy children. FoxP3 stable~     expression requires full CpG demethylation of its transcriptional regulatory regions, and,~     moreover, hypermethylation of the FoxP3 gene has been associated with reduced Treg function~     and allergy.~      DNA methylation is a biologically and chemically stable epigenetic modification that locks in~     long-term gene expression patterns. The demethylation status of FoxP3 at a highly conserved~     region within the Treg-specific-demethylated-region (TSDR), a CpG-rich, located on the 2nd~     conserved non-coding sequence of FoxP3 (CNS2), is restricted to Tregs. Transcriptional~     activity of the TSDR is essentially determined by its methylation status : it is completely~     inactive in its methylated state, but when the TSDR is demethylated, transcription factors~     such as Ets-1 and Creb can bind to the TSDR. TSDR demethylated and open chromatin~     conformation in the Foxp3 locus leads to stable phenotype differentiated Foxp3+ Treg. FoxP3~     TSDR demethylation in peripheral blood mononuclear cells (PBMCs) has been associated with~     reduced atopic sensitization and asthma in children. Epigenetic regulation of antigen-induced~     T-cell subsets may predict a state of immune tolerance in food allergy. Indeed, DNA~     methylation of the FoxP3 gene in Tregs decreased during oral tolerance acquisition in~     patients with peanut allergy undergoing oral immunotherapy. The aim of this study was to~     evaluate further the epigenetic regulation of FoxP3 gene in children with IgE-mediated CMA.~   "
60124|NCT02779868|"~     Cancer cachexia is a complex metabolic process affecting up to 80% of patients suffering from~     an advanced-stage cancer. Moreover, 20 to 40% of all cancer deaths are caused directly by~     cachexia. Recently, omega-3 fatty acids have gained interest for their beneficial effects in~     cancer cachexia. Moreover, nutritional supplementation enriched with omega-3 could~     potentially maintain body weight in cancer patients undergoing intensive treatment.~      The investigators aims in this study is to evaluate the effect of omega-3 supplementation on~     body composition, functional capacity, inflammatory profile and quality of life in cervix~     cancer patients undergoing chemoradiotherapy.~   "
60153|NCT02779478|"~     A biomarker cohort study design is proposed to study whether specific airway microbiota~     alterations are associated with pulmonary Non-tuberculous mycobacteria (NTM) disease. In a~     cohort of 200 subjects suspected of having pulmonary NTM disease, the investigators will~     evaluate the airway microbiome using an aliquot of the induced sputum and upper airway~     samples. Since induced sputum may reflect different regions of the upper/lower airways, the~     investigators will evaluate the upper and lower airway microbiome in a subgroup (case-control~     group) of patients using samples obtained through upper airway sampling and bronchoscopy,~     respectively.~   "
60125|NCT02779855|"~     The purpose of this study is to determine if an oncolytic virus called Talimogene~     laherparepvec (a modified herpes simplex 1 virus that can specifically destroy cancer cells~     while leaving normal cells alone) injected directly into the tumor during chemotherapy prior~     to surgery can enhance the elimination of triple negative breast cancer tumors. The natural~     herpes simplex 1 virus typically causes cold sores around the mouth, but the talimogene~     laherparepvec version of the herpes virus has been changed to prevent it from reproducing in~     normal tissue.~      However, it can still attack and break open cancer tissue which is why it is used as a~     treatment for cancer. It is thought that this virus can also help recruit the participant's~     immune system to attack the cancer cells during their treatment and possibly destroy the~     tumor tissue more effectively than chemotherapy alone. This virus is already FDA approved to~     treat melanoma skin tumors, so investigators want to determine if this virus can achieve a~     similar benefit in women with triple negative breast tumors.~   "
60126|NCT02779842|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
60127|NCT02779829|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
60128|NCT02779803|"~     A prospective registry evaluating the efficacy of EC-IC bypass in a subgroup of patients,~     specifically, patients with carotid occlusion and symptoms refractory to medical therapy and~     evidence for poor cerebrovascular reserve as evaluated by physiological testing (e.g. Diamox~     Challenge SPECT Scan). This subgroup includes:~        1. Hospitalized unstable patient with crescendo or postural TIA's~        2. Patients with multiple TIA's, limb-shaking TIA's, and/or cognitive decline despite~          medical therapy.~   "
60129|NCT02779790|"~     Obesity is a major risk factor for cardiovascular disease and diabetes. Weight loss is an~     important therapeutic goal for overweight and obese patients to reduce their risk of~     developing cardiovascular disease and diabetes. Liquid meal replacements (LMRs) are simple~     tools that may aid in weight loss and may improve weight-related risk cardiometabolic risk~     factors. There is a need to synthesize the evidence on LMRs and cardiometabolic risk to~     inform clinical practice guidelines. The authors propose to conduct a series of systematic~     review and meta-analysis of randomized controlled trials to evaluate the effect of LMRs on 4~     areas of cardiometabolic risk: markers of adipsoity, glycemic control, established lipid~     targets, and blood pressure.~   "
60130|NCT02779777|"~     This a Phase 2 randomized, open-label, two-stage study designed to investigate the antitumor~     activity of tipifarnib in approximately 36 eligible subjects with MDS who have no known~     curative treatment. Subjects will be randomized to receive tipifarnib orally with food~     according to one of 2 treatment regimens.~   "
60131|NCT02779764|"~     The objective of this study is to evaluate the efficacy and safety of ASP1517 in hemodialysis~     patients with renal anemia whose treatment is converted from an Erythropoieses Stimulating~     Agent formulation .~   "
60132|NCT02779751|"~     The main purpose of this study is to evaluate the safety and efficacy of abemaciclib in~     combination with pembrolizumab in participants with advanced non-small cell lung cancer~     (NSCLC) or hormone receptor positive (HR+), human epidermal growth factor receptor negative~     (HER2-) breast cancer.~   "
60133|NCT02779738|"~     The purpose of this study is to evaluate the effect of food on merestinib (standard meal and~     high-fat meal) compared to the fasted state. The study will also measure how much of the~     study drug gets into the blood stream and how long it takes the body to get rid of it. In~     addition, the tolerability of the study drug will be evaluated. Information about any side~     effects that may occur will also be collected. The study will last approximately 28 days.~     Screening is required within 28 days prior to the start of the study.~   "
60134|NCT02779725|"~     This project will determine the most important and cost effective components of~     SymptomCare@Home, a new approach to cancer chemotherapy symptom care that has been shown to~     reduce problematic symptoms through automated daily monitoring, self-management coaching, and~     oncology team follow-up care using decisional support for patients at home when their~     symptoms are most likely at their worse. Once the key parts of the intervention and its cost~     effectiveness are known, it can be moved into everyday cancer care.~   "
60135|NCT02779712|"~     Stroke has an enormous impact on both individual and society. Novel treatments are required~     to relieve this burden and remote ischaemic conditioning (RIC) is one such approach. RIC~     refers to applying non-lethal ischaemia to an area distant from an organ you are trying to~     protect (e.g. the brain). Pre-clinical animal stroke studies have shown RIC to be~     neuroprotective and help restore functional outcome when compared to control. These outcomes~     are achieved simply by transiently occluding the blood supply to a limb (e.g. the arm) very~     soon after the stroke occurs. The mechanisms of protection are unclear but may be due~     enhancing the body's ability to protect itself from further injury by favorably altering~     cerebral blood flow or reducing the detrimental effects of oxygen free radicals. Ischaemic~     conditioning (IC) is an intervention already applied during cardiac surgery to protect the~     heart from damage and it may be effective after an acute myocardial infarction. The~     investigators therefore plan to conduct a pilot randomised controlled trial assessing the~     feasibility of applying RIC (4 cycles of blood pressure cuff inflation for 5 minutes) in~     patients within 6 hours of ischaemic stroke. The primary outcome is feasibility of RIC.~     Secondary outcomes include tolerability, safety and clinical efficacy. The results will~     inform the design of future trials of a potential intervention is that is pragmatic,~     non-invasive and simple to administer.~   "
60136|NCT02779699|"~     A study of AL2846,a C-met/Hepatocyte growth factor tyrosine kinase inhibitor,in patients with~     advanced cancer.~   "
60137|NCT02779686|"~     This study is being conducted to compare two different genetic tests developed to determine~     an individuals risk of developing serious vision threatening complications from age-related~     macular degeneration (ARMD).~   "
60138|NCT02779673|"~     The purpose of randomized, double-blind, placebo-controlled study was to determine whether~     yoghurt drink containing 2g plant stanols (3.4g as plant stanol esters) is effective in the~     control of blood cholesterol level in subjects with LDL-cholesterol level 130-159mg/dL.~   "
60154|NCT02779465|"~     The purpose of this study is to determine whether vitamin D is effective in the prevention of~     hepatocellular carcinoma in those patients with chronic hepatitis B.~   "
60255|NCT02778152|"~     Pilot study to assess tolerability and safety of laser hair depilation in adolescents and~     young adults with pilonidal disease.~   "
60140|NCT02779647|"~     Introduction Overweight and obesity are characterised by excess fat, which results in weight~     gain and is identified by the Body Mass Index (BMI). Studies show that overweight and obesity~     are the result of a complex interaction between genetic and environmental factors, which~     begins prenatally. Various studies have shown that physical exercise is an important~     component of weight loss programmes and that it also benefits the metabolic profile. Other~     authors have reported that greater weight loss is achieved by a programme that includes both~     diet and exercise, rather than either of these alone.~      Aim The aim of this study is to analyse an intervention based on play as a means of improving~     the body composition of children with overweight or obesity.~      Design / Method The design of the Kids-Play study is based on cases and controls. The study~     was conducted in Granada (Spain) from October 2014 to June 2015. The analysis sample of 54~     children was divided into two groups: cases, consisting of 27 children, who participated in~     an intervention programme based on physical activity, play and nutritional advice (to both~     the child and the parents); and controls, another 27 children, who received only nutritional~     advice.~   "
60141|NCT02779634|"~     There are no studies specifically examining the effects of coenzyme Q (CoQ) treatment on~     echocardiographic indices of diastolic function in elderly patients with heart failure with~     preserved ejection fraction (HFPEF). In previous studies the only echocardiographic~     parameters studied were ejection fraction (EF) and chamber size. The objective of the~     proposed current study is to examine the effect of 16 weeks of ubiquinol therapy on diastolic~     function assessed by echocardiography in patients over the age of 50 with a clinical~     diagnosis of HFPEF. Ubiquinol (Kaneka Pharma), the reduced form of CoQ will be utilized for~     this study as it has been shown to have superior bioavailability when compared to oxidized~     CoQ.~   "
60142|NCT02779621|"~     To explore the potential for vaginal self-sampling to increase participation in cervical~     screening, we offer the option of self-sampling to a group of non-participants in cervical~     screening (intervention), in addition to the routine screening (smear) test. Women in the~     control group will only receive the routine screening invitation letter. The total screening~     uptake rate, 2 months since the recruitment in each group will be compared.~   "
60143|NCT02779608|"~     This is a clinical Study to evaluate the effect, survival benefit and safety of~     intraperitoneal docetaxel combined with oral S-1 for advanced gastric cancer with malignant~     ascites.~   "
60144|NCT02779595|"~     Perioperative changes in regional ventilation by pulmonary electrical impedance tomography~     and spirometry will be investigated in patients at risk for postoperative pulmonary~     complications. Those patients undergo lung and flail chest surgery.~   "
60145|NCT02779582|"~     This study is designed to evaluate the within-woman effect of oral micronized progesterone~     (Progesterone 300 mg at bedtime) on semi-quantitative menstrual flow measured by the DivaCup®~     (menstrual cup with volume indicators at 7.5, 15 and 30 ml) or by counting the number of~     soaked normal-sized sanitary products such as normal-sized tampons or pads as well as length~     of flow and frequency and severity of menstrual cramps (on a 0-4 scale) in women with hot~     flushes and night sweats who are qualified to enroll in the primary perimenopausal hot flush~     trial stratified by whether they are in Early or Late Perimenopause.~   "
60146|NCT02779569|"~     To evaluate the safety and clinical efficacy of ultra-low-dose decitabine in Chinese MDS~   "
60147|NCT02779556|"~     The researchers will conduct a patient-randomized, pragmatic clinical trial among 6 rural~     PCMHs in Arkansas, targeting individuals with uncontrolled type 2 diabetes.~      The primary aims are to:~        1. test the effectiveness of the ACP diabetes health literacy intervention to improve a~          range of diabetes-related outcomes among rural patients;~        2. compared to usual care, evaluate whether the intervention reduces disparities by patient~          literacy level.~           The secondary aims are to:~        3. investigate whether a threshold or gradient effect exists between the amount of~          follow-up counseling (number of action plans) and intervention effectiveness;~        4. determine the fidelity of all intervention components, and explore any identified~          patient, provider (physician, nurse, health coach), and/or health system barriers to~          implementation; and~        5. assess the costs associated with implementing the intervention from a health system~          perspective.~   "
60148|NCT02779543|"~     This study seeks to validate three new commercial sleep monitoring devices: Fitbit, Jawbone~     UP, and Microsoft Band by comparison against concurrent polysomnography (PSG), which is~     considered the gold standard for sleep assessment. This research is being done because if~     proven to accurately analyze sleep,these devices may make conducting in-home sleep studies~     easier and more affordable in the future.~   "
60149|NCT02779530|"~     Randomized, double-blinded, cross-over and placebo controlled clinical trial to evaluate the~     association between genetic polymorphism of CYP4F2 with cardiovascular adverse effects of~     non-steroidal anti-inflammatory drugs (NSAIDs). Two groups were included according the CYP4F2~     V433M genetic polymorphism (control - MM, N=7 vs. VV or VM variants, N=13). According the~     sample size planned, a mean difference of total body water delta between groups (control vs.~     polymorphic) of at least allow 10% could be observed.~   "
60150|NCT02779517|"~     By developing an affordable mobile service robot for therapeutic activities in a health~     center environment, this project addresses the issue of both the high cost and man-power~     required to provide rehabilitation for stroke survivors and other patients. Our goal is to~     measure users - clinician and patient - responses to a telepresence robot, VGo, that has been~     modified with a humanoid torso robot, NAO, to facilitate remote communication between the~     patient and clinician, and to complete supervisory exercise coaching.~   "
60151|NCT02779504|"~     The Agluna® (antimicrobial ionic silver surface technology) is used to treat the surface of~     the METS (Modular Endoprosthetic Tumour System) medical devices, in order to reduce the risk~     of post surgical infections after orthopaedic endoprosthetic replacement surgery.~      This Post Market Clinical Follow up study is designed to retrospectively establish the~     infection rate of a cohort patients who have received an Agluna® Treated METS implant and~     compare the clinical data to patients that have received an untreated METS implant; in order~     to provide evidence to support the investigators' clinical claims.~   "
60152|NCT02779491|"~     This is a randomized controlled trial to assess the impact of a novel fruit and vegetable~     mobile phone application on fruit and vegetable intakes, knowledge and attitudes.~   "
60297|NCT02777606|"~     The purpose of this study is to evaluate the efficacy of Si-Ni-Tang (a Chinese Herbal Formula~     documented in Shang Han Lun) in treating severe sepsis.~   "
60155|NCT02779452|"~     The purpose of this study is to evaluate the feasibility of using a quantitative EEG method~     to evaluate neurodevelopment in newborns and to evaluate whether subtle neurodevelopmental~     deficits can be detected in newborns from mothers with gestational diabetes mellitus (GDM)~     compared to control newborns.~      The second purpose of this study is to determine whether cord blood concentration in~     docosahexaenoic acid (DHA), an omega-3 fatty acid, is similar in neonates of well-controlled~     mothers with gestational diabetes mellitus (GDM) compared to control mothers, and to evaluate~     whether this contributes to neonates neurodevelopment status.~   "
60156|NCT02779439|"~     To assess the safety and biological efficacy of therapeutically administered most closely~     HLA-matched third party donor-derived specific cytotoxic T lymphocytes (CTLs) targeting~     cytomegalovirus (CMV) or Adenovirus (Adv) or Epstein Barr virus (EBV) or fungi including~     Aspergillus and Candida species for the treatment of viral infection following allogeneic~     blood or marrow stem cell or solid organ transplantation.~   "
60157|NCT02779426|"~     The purpose of this study is to determine if sending text messages with treatment reminders~     and facts regarding atopic dermatitis (AD) to caretakers of children with AD will have a~     positive effect on the disease severity.~   "
60158|NCT02779413|"~     This study is conducted in Asia. The aim of the study is to evaluate safety and effectiveness~     in patients of all age groups excluding less than 12 month old infants with diabetes mellitus~     in routine clinical practice in Korea.~   "
60159|NCT02779400|"~     The purpose of this study is to assess the measurement conformity of an in vitro diagnostic~     device measuring the INR (International harmonized Ratio).~   "
60160|NCT02779387|"~     This study is a multicenter, randomized-control-trial. This study select 1184 Infertile~     patients associated with endometriosis diagnosed by laparoscopy surgery. Patients are going~     to be divided into two groups according to 1:1 ratio randomly assigned to receive GnRH-a.~     Cumulative pregnancy rate, end of treatment to natural pregnancy time, accept the assisted~     reproductive treatment rate, miscarriage rate, live birth rate will be recorded.~   "
60161|NCT02779374|"~     Currently, There is no treatment for Premature ovarian insufficiency (POI). Very small~     embryonic-like stem cells (VSELs) are found in the ovary. VSELs are able to regenerate the~     affected ovary. Stimulation was achieved by injection of mesenchymal stem cells that is~     supposed to secrete trophic factors.~      Numerous studies in mice have proved the efficacy of bone marrow transplantation (BMT) in~     resuming the ovarian function after chemotherapy-induced ovarian insufficiency.~      Allogeneic BMT raised the moral conflict about the origin of the newly developed oocytes.~     Several small studies examined the use of autologous BMT both in animal and in human. The~     results of these studies were promising. Intravenous injection is simpler and less invasive~     than ovarian injection as the later involves the use of laparoscopy. However, intravenous~     injection has not tested until now.~   "
60162|NCT02779361|"~     Open label phase I clinical trial in healthy volunteers designed to assess changes on steroid~     profile after green tea consumption.~   "
60163|NCT02779348|"~     The purpose of this study is to determine whether multiple-dose administration of nebicapone~     affects the pharmacokinetics of warfarin.~   "
60164|NCT02779335|"~     The purpose of this prospective study seeks to assess ability to achieve enteral feeding~     goals with standard polymeric enteral formula in a stable, pediatric tube-fed population.~   "
60165|NCT02779322|"~     This study try to identify differences in cost, length of operation and results between two~     different bariatric surgical techniques, the laparoscopic Roux-en-Y gastric bypass and the~     Single anastomosis laparoscopic gastric bypass. The study will be conducted in a Spanish~     public health system hospital.~      The patients of the trial will have the preoperative studies, hospital treatment during the~     admission, postoperative treatment and follow up as any other patient included in the~     hospital bariatric surgery program. No new methods are applied other than randomly choose the~     surgical technique.~      Patients will be randomized in a 1:1 ratio to each group.~   "
60166|NCT02779309|"~     To develop a mortality risk prediction model that can be applied to the wide spectrum of~     risks that are seen in the home care setting.~   "
60167|NCT02779296|"~     Surgical Site Infections (SSI) represents a significant complication in plastic surgery.~     Infections can result in a prolonged recovery and impair long-term cosmetic appearance. One~     potential method to reduce infection is by applying a thin layer of dermal glue over the~     sutures at the site of incision immediately after the surgery. Conventional closures, such as~     sutures or staples, leave the site vulnerable until epithelialization occurs in 24 to 48~     hours. In contrast, dermal glue provides an instant, waterproof barrier and it has been shown~     to have intrinsic bacteriostatic properties. The glue is supplied as a liquid enclosed in a~     vial and when applied, polymerizes rapidly in an exothermic reaction in the presence of~     moisture to form a solid adhesive. 2-Octylcyanoacrylate (2-OCA)-based glue is formulated to~     be more flexible than previous preparations. The application of dermal glue is rapid, simple~     and requires no specific follow-up as it naturally sloughs off overtime. The purpose of this~     study is to determine if 2-OCA-based glue can reduce the rate of surgical site infection~     following surgery. Patients undergoing breast surgery will be recruited and randomized to~     either a group receiving a layer of glue over sutures following surgery or no treatment.~     Patients will be followed up at 30 days and at 8 months for signs of infection, additional~     complications and the visual appearance of the scars. The cost of treating and infection will~     be calculated to determine if using dermal glue to prevent infection is economically~     feasible. This research has the potential to find a method to reduce surgical site infection,~     which can be applied to other surgeries.~   "
60175|NCT02779192|"~     SPI-1005 is a novel oral drug that contains a glutathione peroxidase mimetic (ebselen) that~     will be tested in subjects with a history of NIHL at risk for additional NIHL. The goal of~     this multi-center Phase 2b study is to determine whether SPI-1005 is effective in reducing an~     acute NIHL in this affected population. In this Phase 2b study subjects with prior NIHL will~     be enrolled and exposed to a calibrated sound challenge (CSC) that induces a slight acute~     NIHL.~   "
60256|NCT02778139|"~     The aims of this study were: (1) to examine the risk behaviours, lifestyle and its associated~     psychosocial factors for youth smokers; and (2) to explore the relationships among~     self-esteem, depressive symptoms and quality of life in youth smokers.~   "
72747|NCT02614742|"~     This is a Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of SFX-01 in~     Subarachnoid Haemorrhage, with exploratory evaluations of efficacy.~   "
60168|NCT02779283|"~     This phase IB trial studies the feasibility of using a functional laboratory based study to~     determine how well the test can be used to select personalized kinase inhibitor therapy in~     combination with standard chemotherapy in treating patients with newly diagnosed acute~     myeloid leukemia (AML). It also evaluates safety and potential efficacy. Kinase inhibitor is~     a type of substance that blocks an enzyme called a kinase. Human cells have many different~     kinase enzymes, and they help control important cell functions. Certain kinases are more~     active in some types of cancer cells and blocking them may help keep the cancer cells from~     growing. Testing samples of blood from patients with AML in the laboratory with kinase~     inhibitors may help determine which kinase inhibitor has more activity against cancer cells~     and which one should be combined with standard of care chemotherapy. Drugs used in~     chemotherapy work in different ways to stop the growth of cancer cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Giving a~     personalized kinase inhibitor therapy combined with standard chemotherapy may be a better~     treatment for AML.~   "
60169|NCT02779270|"~     To assess the safety of a sunscreen product when used outdoor.~   "
60170|NCT02779257|"~     Pasireotide binds to somatostatin receptors sst2 and sst5, which can lead to significant~     hyperglycemia. The investigators would like to administer pasireotide as a treatment for~     refractory hypoglycemia in the setting of metastatic insulin-producing pancreatic~     neuro-endocrine tumor.~   "
60171|NCT02779244|"~     The purpose of this randomized, controlled trial is to estimate the safety of early weight~     bearing on post ankle surgery.~      Patients who are indicated to have surgery for unstable ankle fractures by an attending~     trauma physician will be consented for participation in the study. After surgery patients~     will be randomized to either weight bearing as tolerated at two weeks with a cam boot or~     non-weight bearing with a cam boot. Randomization will be performed by number allocation with~     odd numbers in the early weight bearing group and even numbers in the non-weight bearing~     group. The surgeon will be blinded to this until after the surgery. The patients will all be~     placed in a short leg cast post operative and made non-weight bearing for 2 weeks until~     sutures are removed which is current standard treatment. Both groups will be asked to~     initiate weight bearing at two weeks post operatively by wearing a cam boot that is non~     weight bearing in a cam boot, the latter being standard treatment.~   "
60172|NCT02779231|"~     Hypertension remains one of the most important preventable contributors to disease and death.~     It is the most common risk factor for strokes and myocardial infarctions in the U.S., and is~     associated with the greatest attributable risk for mortality among all modifiable risk~     factors for cardiovascular events. Over 50 million people are living with hypertension in the~     United States, and hypertension is one of the most common reasons for visits to a healthcare~     provider. Abundant evidence from randomized controlled trials has shown benefit of~     antihypertensive drug treatment in reducing important health outcomes in persons with~     hypertension. Yet, approximately 20% of U.S. adults are unaware that they have the disease.~      Hypertension is more difficult to diagnose than other common medical illnesses. In most~     cases, hypertension is asymptomatic; and accordingly patients do not seek care for it as they~     do for other common symptomatic illness. Patients are frequently diagnosed after presenting~     with end organ disease (e.g., myocardial infarctions, congestive heart failure, strokes, or~     renal failure). Another complicating aspect related to diagnosing uncontrolled hypertension~     is that multiple blood pressure measurements are needed to establish a diagnosis. Blood~     pressure readings can be falsely elevated in clinic due to the presence of an observer or the~     clinical surrounding (e.g., white coat hypertension). Even if an elevated blood pressure~     reading is identified in a clinic setting, more readings are needed in order to make it~     possible for physicians to decide about the next appropriate medical intervention. This need~     for multiple BP measurements over time often delays both initiating and modifying medical~     therapy for uncontrolled hypertension.~      Having patients take their BP at home facilitates the more timely diagnosis of uncontrolled~     hypertension by reducing diagnostic uncertainty. In fact, home measurements are better~     diagnostic indicators of stroke and cardiovascular mortality than clinic readings, are more~     closely correlated with end-organ damage, and are cost effective and well-tolerated by~     patients.~      Patients are frequently asked to record their BP after clinic visits. Historically, patients~     used a hand-written log, but more recently, patients are instructed to use an Internet-based~     web portal that uploads values to the patient's electronic medical record. Compliance with~     either approach relies on effective patient and provider followup, and in many settings,~     nurses or pharmacists will need to call patients to prompt them for their blood pressure~     measurements, which is both a costly and time consuming approach. Therefore, researchers need~     to develop effective, yet low cost alternatives to monitoring home blood pressure.~      This study proposes such a solution. The purpose of this study is to evaluate a simple~     m-health intervention to increase the ease and efficacy of diagnosing uncontrolled~     hypertension and achieve better blood pressure control in hypertensive patients.~   "
60173|NCT02779218|"~     Strokes represent, in industrialized countries the leading cause of acquired motor disability~     in adults older than 40. Stroke is responsible for France from 150 000 to 200 000 new cases~     of hemiplegia each year. These patients will see their deficit to improve during the first 6~     months after stroke. This recovery is largely based on brain plasticity mechanisms and the~     rehabilitation has as main objective to optimize these mechanisms. However, only 20% of~     patients hospitalized in a rehabilitation sector recover a functional upper limb. This lack~     of functionality is not only due to overall strength gap but also to the predominance of this~     gap on the extension movements of the wrist and fingers.~      Meanwhile, work on brain plasticity helped develop new techniques of non-invasive brain~     stimulation (Non-invasive Brain Stimulation, NIBS) as the model of coupled stimulations~     (Paired Associative Stimulation, PAS) for modulating way over effective brain plasticity. In~     previous studies, the investigators have shown over a 30 minutes session lasting facilitation~     (60mn) and specific motor evoked potential (MEP) of the Extensor Carpi Radialis (ECR).~     Several studies showed an adjuvant effect when GSIN were associated with learning of a motor~     task. For PAS, some studies have shown a greater facilitation when the latter is associated~     with muscle contraction.~      The motor imagery (MI) is imagining a movement without realizing it, it is based on~     mechanisms similar to those of the real movement. This technique also showed its effects as~     an adjuvant therapy in hemiplegic patients, however, they remain lower than those obtained~     after a motor drive. Its use in patients with no motor makes its uniqueness and strength.~   "
60174|NCT02779205|"~     The beneficial effect related to the administration of adipose tissue-derived stromal cells~     (ADSC) is demonstrated in various situations of physiological and pathological wound healing,~     thus opening a new field for cell therapy. Despite the use of new technologies, management of~     burns in children as well as congenital malformation such as hypospadias and cleft lip and/~     or cleft palate can lead to aesthetic and functional sequelae requiring multiple surgical~     procedures. Cell therapy based on the administration of the ADSC seems a promising issue in~     such indications, however, to date no study has been conducted with ADSC from a pediatric~     population. An initial study (Protocol 0808203) allowed investigors to obtain the first~     samples of adipose tissue from children and to conduct an in vitro comparative study on the~     characterization and properties of the ADSC from children compared to adults. In the~     continuity, this second study aims to complete knowledge on the efficacy and safety of~     children ADSC cell therapy assessed in an animal model of skin wound healing developed in the~     lab.~   "
60176|NCT02779179|"~     Although RA pathomechanisms remains incompletely understood, periodontitis and RA share~     pathogenic features : genetic and environmental influences, chronic inflammatory disease,~     immunoregulatory imbalance, bacterial factors, persistence of antigen/peptide and clinical~     factors (conjunctive and hard tissues destruction). Several hypothesis can be evocated : Gram~     negative bacterial systemic spreading, inflammatory transmitter substance systemic spreading~     (IL1, IL6, IL17, PGE2), systemic spreading of bacterial degradation products (LPS for~     example).~      Currently Porphyromonas gingivalis (PG) might be a susceptibility factor to RA because PG has~     an enzyme, the peptidylarginine deiminase leading to auto antibodies creation and RA~     increasing. As periodontitis, RA is chronic disease with a cyclic increase evolution, needing~     a complex pluridisciplinary treatment approach. Recent studies have reported an increased~     prevalence of RA patients with periodontal disease. Others studies show that periodontal~     treatment induces a significant decrease of the sedimentation rate and of the DAS28.~     Periodontitis is suspected to be an independent, aggravating factor in patients with RA~     (given the definition from NIH : an aggravating factor is something that makes a condition~     worse). So periodontal treatment cannot be considered as a RA treatment per se. But it is~     hypothesised that treating periodontitis in RA patients showing signs of periodontitis could~     result in improvement in RA disease activity. To date the role of periodontitis as an~     aggravating factor in these patients remains unclear, and only RCT designs can reasonably be~     used to test this causal hypothesis. There still remains some RA patients who have persistent~     symptoms and frequent exacerbations despite specialist care and continuous treatment, so~     results of treating aggravating factors are needed. As the majority of patients will benefit~     from a systematic evaluation and treatment of aggravating factors, the periodontal treatment~     strategy need to be tested.~      The aim of this randomised controlled trial is to assess the effectiveness of periodontal~     treatment for rheumatoid arthritis patients.~      To assess the effectiveness of periodontal treatment to reduce the severity of rheumatoid~     arthritis (RA), in patients suffering from both periodontitis and rheumatoid arthritis. The~     hypothesis is that periodontal treatment reduce the severity of rheumatoid arthritis.~   "
60177|NCT02779166|"~     Celecoxib is commonly used for perioperative pain control for certain orthopaedic procedures.~     It has been shown to be successful in assisting in pain control for knee arthroscopy. It has~     not previously been studied in hip arthroscopy. This is a double blinded randomized~     controlled trial to determine the efficacy of celecoxib in perioperative pain control for hip~     arthroscopy.~   "
60178|NCT02779153|"~     This is a randomized study exploring the efficacy, safety and steroid sparing ability of two~     doses (40 U and 80 U) of Acthar in SLE patients with immune mediated hematologic~     manifestations requiring steroid use for a minimum of 2 weeks prior to screening.~   "
60179|NCT02779140|"~     This is a Phase I, randomized, double-blind, placebo controlled dose escalation trial to~     evaluate NTM-1632 in three dose cohorts (A: 0.033 mg/kg, B: 0.165 mg/kg, and C: 0.33 mg/kg).~     NTM-1632 is a mixture of three monoclonal antibodies designed to treat botulinum neurotoxin~     BoNT/B poisoning in adults. Dose cohorts A, B, and C will be randomized 2:6,~     placebo:therapeutic, with a total study population of 24. The study duration is projected to~     be approximately 8 months, with subject participation in cohort A being approximately 13~     weeks, and subject participation in cohort B and C being approximately 17 weeks. The primary~     objectives of this study are to assess the safety and tolerability of escalating doses of~     NTM-1632 administered intravenously in healthy adults.~   "
60180|NCT02779127|"~     Endothelium is considered a real member, so it is contributing to determine the vascular~     homeostasis. The presence of endothelial dysfunction, evaluated in peripheral arteries by~     non-invasive study of the variation of gauge of the brachial artery as a result of~     post-ischemic hyperemia (FMD), is predictive of occurrence of major cardiovascular events.~     Several recent studies have shown that passive smoking is correlated with endothelial~     dysfunction and, therefore, non-smokers exposed subjects to passive smoking, have an~     increased risk of occurrence cardiovascular pathologies. From January 2008, a ministerial~     decree will ban smoking in bars, restaurants and nightclubs. The impact of exposure end to~     smoking in non-smoking subjects, as part of a prospective study and controlled, has never~     been evaluated.~   "
60181|NCT02779114|"~     This is a phase 3, multicenter, randomized, open, prospective, controlled, parallel-group~     intervention study in 318 patients with Rheumatoid Arthritis. The study is composed of 3~     phases: a pre-randomization phase for up to 10 days followed by a 1-year randomized, open~     three arm treatment phase for each patient, followed by a 5-year observational phase for all~     patients still in remission.~   "
60182|NCT02779101|"~     In summary, there is a high medical need for patients suffering from recurrent/progressive~     PCNSL. Targeting the PD-1 pathway may represent a very promising novel approach for the~     treatment of these patients.~   "
60183|NCT02779088|"~     This cohort study will establish the urban elderly cohort, measure both physical and~     functional parameters, find the risk factors for aging, and validate the role of strength~     training for those sarcopenic patients. Investigators hope this study will be widely cited in~     related fields in the future.~   "
60184|NCT02779075|"~     The overall aim of the application is to determine the contribution of the elevated incretin~     hormone concentrations seen after certain types of bariatric surgery to the regulation of~     food intake and satiety.~   "
60185|NCT02779062|"~     Infants sometimes experience sudden symptoms such as breathing irregularities or limpness~     that frighten parents and prompt them to seek emergency medical care. While few of these~     episodes are truly life-threatening and require hospital admission, some parents may have~     been so frightened that they will resist returning home from the emergency department with~     their baby even if the objective risk is extremely small. Study subjects (parents of infants~     with an apparent life threatening event) will be contacted and interviewed. Investigators~     want to learn whether or not study subjects would accept returning home after a brief period~     of observation in the emergency department if the physician determines that it is safe to do~     so.~   "
60186|NCT02779049|"~     1. To understand the components of PBMC in MAC-LD patients, including T cells, B cells,~          nature killer cells, and monocyte.~        2. To confirm the phenomenon of reduced PBMC response in MAC-LD patients~        3. To study the proportion of apoptosis and PD-1 expression in T cells among MAC-LD~          patients, MAC colonizers, patients with tuberculosis, and healthy controls.~        4. To study the apoptosis and PD-1/PD-L1 expression in T cells/macrophage from bronchial~          lavage among MAC-LD patients, MAC colonizers, patients with tuberculosis,~        5. To examine the PD-1 gene polymorphism and the correlation with MAC-LD.~   "
60187|NCT02779036|"~     In a randomized-controlled study, the effects of a structured, progressive, task-oriented~     home exercise program to optimize walking competency will be evaluated in subacute stroke~     survivors.~   "
60201|NCT02778854|"~     The purpose of this study is to evaluate the diagnostic and prognostic efficacy of liquid~     biopsy in different specimens and in different methods compared with tissue detection .~   "
60298|NCT02777593|"~     The objective of this study is to determine whether the GORE® TAG® Thoracic Branch~     Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending~     thoracic aorta.~   "
60188|NCT02779023|"~     This study investigates the feasibility, acceptability, and effectiveness of adding~     Cognitive-Behavioral Therapy for Insomnia (CBT-I) to the standard care received at the~     Integrative Cardiac Health Project (ICHP) on insomnia symptoms and severity. ICHP is an~     established cardiovascular disease prevention program to reduce cardiovascular disease risk~     through the adoption of lifestyle changes related to improvements in diet, stress, sleep, and~     exercise. The study will be conducted among patients with insomnia who are already enrolled~     in the ICHP cardiovascular risk prevention program.~      This is a single-center study, prospective, randomized, controlled, interventional trial~     within ICHP at the Walter Reed National Military Medical Center (WRNMMC). To conduct both~     phases of the study, up to 64 total male and female patients enrolled in ICHP who meet~     criteria for insomnia will be recruited. Participants who meet inclusion and exclusion~     criteria for this study, and consent to participate, will be randomized to one of two~     conditions: (1) ICHP, or (2) ICHP + CBT-I treatment. CBT-I treatment will consist of four~     in-person appointments and two telephone appointments.~   "
60189|NCT02779010|"~     The investigators evaluated the impact of water, sanitation and hygiene educational~     Intervention and hand washing with soap on the incidence of diarrhea among under-five~     children.~   "
60190|NCT02778997|"~     Complications in patients with cerebrospinal fluid (CSF) shunts are common. Thus, these~     patients are frequently admitted for suspicion of a shunt dysfunction (SD). However, the~     symptoms of a SD are often unspecific and the required diagnostics are time consuming,~     expensive, invasive and may involve radiation exposure. In a prospective observational study~     it is planned to find out, how often a suspected shunt dysfunction is found, which kinds of~     shunt dysfunction are seen and if there is a correlation between the shunt dysfunctions and~     the age of the shunt. Furthermore, it is intended to find out, if there are symptom-patterns~     specific for certain shunt dysfunctions.~   "
60191|NCT02778984|"~     A correct preoxygenation can be obtained after a 3min delay of calm ventilation through a~     tight mask thereafter mask is used to make the patient breathing before intubation. Most~     tight masks are actually sold but they have never been compared in studies. The aim of this~     study is to compare air leaks with standard facial mask and QuadraLite masks during~     preoxygenation and induction of anesthesia.~   "
60192|NCT02778971|"~     The main purpose of this study is to explore the impact of an amyloid positron emission~     tomography and computed tomography (PET/CT) scan on physician diagnosis and management,~     including drug management and care practices, for patients with a diagnosis of cognitive~     impairment. This study also intends to capture specific patient-reported outcomes related to~     patient burden, confidence and satisfaction.~      The hypothesis is that to aid early diagnosis, individuals with a diagnostically uncertain~     etiology for their dementia will benefit from knowledge of amyloid plaque burden status,~     through an alteration of patient diagnosis and management, which will lead to significant~     changes in patient and care partner reported outcomes.~   "
60193|NCT02778958|"~     The aim of this study is to evaluate and to compare the effectiveness of iv ibuprofen and iv~     paracetamol during bariatric surgery.~   "
60194|NCT02778945|"~     In the present study, the investigators compare intermediate and deep NMB i.e. the two~     extreme regimes of muscle paralysis (neuromuscular block; NMB), (I) patients receiving~     intermediate muscle paralysis (''control, conventional NMB'') versus (II) patients with a~     deep neuromuscular blockade with rocuronium (''Deep NMB''), will be compared during a~     surgical procedure which is considered to be very sensitive for inadequate muscle relaxation,~     elective minimally invasive spinal surgery.~      The primary objective of this trial is to compare the operation time reduction with the help~     of the decreased stiffness of targeted back muscle surrounding the surgical field.~      The changed back muscle stiffness also measured as secondary objective goal by a mechanical~     tension weighing scale and also taking ultrasonography using shear wave elastography (SWE).~      Other observational objectives are divided into the following categories of stakeholders:~     patients, surgeons and anesthesiologists', done by collecting the variety of clinical~     parameters. The following will be collected and compared.~        1. For patients Intraoperative radiation amount, post-anesthetic care unit(PACU) stay,~          transfer rate to SICU for post-op. care, post-operative respiratory complication rate,~          and total hospital costs.~        2. For surgeons Post-operative complications in regard to operation field, and evaluate~          surgical conditions using a Visual Analogue Scale(VAS score) in surgeon's side.~        3. For anesthesiologists Intraoperative ventilation parameters of patients, and evaluate~          surgical conditions using a Visual Analogue Scale(VAS score) in anesthesiologist's side.~   "
60195|NCT02778932|"~     Pars plana vitrectomy is usually performed under general anesthesia including endotracheal~     intubation and muscle relaxation. However, for short procedures anesthesia using a laryngeal~     mask without muscle relaxation is also common in practice. In this observational study the~     incidence of patient movement will be examined between these anesthesia techniques.~   "
60196|NCT02778919|"~     The purpose of this study is to evaluate the efficacy, safety, and dose-response relationship~     of KLH-2109 compared to placebo in Japanese patients with endometriosis.~   "
60197|NCT02778906|"~     This is a randomised double-blinded placebo-controlled multi centre study in 98 patients with~     ACPA positive arthralgia. The study is composed of 2 arms with a 1:1 randomisation at~     baseline: Treatment phase will be 6 months. Group 1: Abatacept s.c. 125 mg weekly for 6~     months vs. Group 2: Placebo s.c. for 6 months. After 6 months both groups will run into the~     follow up period for another 12 months up to month 18. Patients developing arthritis will be~     treated according to local guidelines.~   "
60198|NCT02778893|"~     Our study the NSCLC harbors EGFR-mutation with Conmana combined with thalidomide as~     first-line treatment, is expected to improve further EGFR-Tyrosine kinase inhibitors (TKI)~     response rate (ORR), prolong time to progression (PFS), improve patient survival.~   "
60199|NCT02778880|"~     This study compares the analgesic effect of intranasal sub-dissociative dosing of ketamine~     and intranasal fentanyl in children presenting to the Emergency Department with acute~     extremity injuries.~   "
60200|NCT02778867|"~     The purpose of this interventional study is to test and compare the effectiveness of two~     elimination diets—the 1-food elimination diet (1FED, milk only) and the 6-food elimination~     diet (6FED, milk, egg, wheat, soy, tree nut/peanuts, and fish/shellfish). The study will also~     test the effectiveness of swallowed glucocorticoid therapy in some of the study participants~     for whom diet therapy was not effective.~   "
60202|NCT02778841|"~     Falling of the elderly as one of the greatest issues and major health problems among the~     elderly population has produced a further discussion among gerontologists and physical~     therapists. Moreover, they are considered as one of the major health problems among the aging~     population and by now around a third of 65-year-old adults fall as a minimum once a year~     while 6% of such falls cause fractures. Loss of the balance is the main reason for falling~     among the elderly. Proprioception is the sensory feedback regarding the joint position sense~     and movement which can accordingly lead to a decrease in the postural stability and~     steadiness of the elderly people. Proprioception has shown to be a risk factor for falls in~     older people. proprioception can be modified by physical training. Recently, exergaming, the~     playing of video games with body movements, has been proposed as effective strategy to~     deliver exercise.~      Aim of study: the current research investigates the effect of 8 weeks videogame game~     exercise, conventional balance exercise, and a combined of the two (mixed training) on knee~     proprioception, static balance, and mobility of elderly male. Methodology: The study was~     designed as a single-blinded, randomized, controlled intervention trial. Sixty-four male ages~     65 years and above were randomly assigned into an exergame group, a traditional balance~     exercise group, a mixed training group or a passive control group. After pretest all~     participant perform 8 weeks of exercise and measured the effects of the training regimens on~     proprioception and other functional outcomes as well as mood states in healthy older adults.~   "
60203|NCT02778828|"~     Linezolid, primary treatment for MDR-TB combination therapy anti. Until it is the dose of 600~     mg x1 / day, rather sensible for most patients is more, which was unanimous. It is true that~     if a dosage is consensus, it goes without saying, because of the interindividual variability,~     marked moreover to linezolid, a therapeutic monitoring assay of plasma levels is~     indispensable for most pharmacological treatments. This therapeutic drug monitoring (TDM)~     often gives rise, as known, to dosage changes. It turns out that at present no real STP on~     the basic objectives PK / PD is really made in France in the treatment of tuberculosis (TB)~     and the bibliography remains rather poor recommendations, and yet all the elements are there:~     indeed linezolid is an antibiotic whose activity is purely time-dependent. So one should~     fulfill 2 PK / PD objectives whose precise boundaries are sometimes still to be determined:~      -% T> MIC, or percentage of time spent with plasma concentrations above the minimum~     inhibitory concentration of linezolid (LNZ) for Mycobacterium tuberculosis. In practice, the~     residual concentration before the next shot must be> MIC (0.125 to 1 mg / l)~        -  A fortiori it must also take into account the concentration preventing the appearance of~          resistant mutants, amounting to 1.2 mg / l~        -  AUC / MIC> 80, or ratio of the area under the curve (AUC, Area under curve) of plasma~          concentration versus time and CMI LNZ Until then, and without real bibliographic~          support, and for the sake of kindness to patients coupled with an economic advantage,~          the STP consisted of 2 samples, a peak 1:30 after taking (Cmax) and a residual before~          taking (C min) , after all, to 600mg x1 / 24 correlates well with the AUC (55% peak and~          75% for the residual).~      Following an observation that 25 to 30% of patients had a C min <1.2 mg / L, and even~     frequently <0.2 mg / L to 600 mg x 1, with some low peaks and leaving presage an AUC may be~     insufficient well.~      This study is therefore more imperative to be a pharmacological streamlining and ensuring~     adequate therapeutic monitoring involves both maximum and minimum toxicity efficiency. And in~     the light of what has already been practiced for other molecules such as mycophenolate for~     example which is carried AUC or miniAUC for example. It would therefore be in the achievement~     of AUC in all patients treated with LNZ for TB MDR / XDR for over a week. Achieving this~     requires AUC obtaining 7 blood samples given day instead of two samples taken at present.~     Indeed one must have in mind that the peak of rational / residual has become blurred in this~     context, and that one of the two goals PK / PD is now filled (Cmin> MIC / CMP) but it should~     not be that not at the expense of the second (AUC). The benefits, direct and indirect are~     multiple and obtaining them is ensured through this protocol. The study by analyzing~     individual data will confirm the accuracy of the dose fractionation 300mgx2 / day and at a~     time to highlight a potential new dosage adjustment that would need to achieve for further~     study, so a substantial gain in terms of efficacy and toxicity via a suitable therapeutic~     monitoring. Secondly, determine which collection points, in these patients, these doses will~     be most interesting to take later in the routine of STP in order to collect less points (eg~     miniAUC MPA) retaining same statistical power to estimate kinetic parameters, mainly the AUC~     (eg aminoglycoside also). Finally in a third phase construction on the basis of these~     individual kinetics of a population pharmacokinetic model with highlighting of population~     parameters and especially co-related variables explaining the high pharmacokinetic~     variability and allowing for following patients to determine the individually tailored dose~     immediately before the first shot and the first assays.~   "
60204|NCT02778815|"~     This study examines the relationship between self-compassion and wellbeing in new mothers and~     whether an online self-help course for new mothers can help to improve their wellbeing and~     self-compassion.~   "
60205|NCT02778802|"~     This study is designed as a prospective study, with the primary endpoint being changes in~     pulmonary hemodynamic parameters after ELVR in patients with severe emphysema.~      Secondary endpoints will be changes in lung function parameters, exercise capacity, and QoL.~   "
60206|NCT02778789|"~     Comparing the structural effects of TNFi and tocilizumab on the periarticular bone by~     performing a comprehensive analysis of the periarticular bone changes in RA patients treated~     with either TNFi or tocilizumab in a longitudinal Setting, using high-resolution peripheral~     quantitative computed tomography (HR-pQCT), a very sensitive method for visualizing and~     quantifying bone microstructure in RA patients. Quantitatively assessing the changes of~     erosions volume, osteophytes size and the area of cortical fenestration in a group of~     TNFi-treated and a group of tocilizumab- treated RA patients.~   "
60207|NCT02778776|"~     Type 2 diabetes mellitus, insulin resistance, visceral obesity and disorders of lipid~     metabolism, especially triglyceride and hypertension are metabolic disorders that play a~     central role in pathophysiology of metabolic syndrome, and ultimately, the cardiovascular~     morbidity and mortality associated with atherosclerosis, such as myocardial infarction,~     cerebral vascular events, vascular dementia, heart failure and end stage renal disease.~     Recently other complications related with hyperinsulinemia like the prostate benign~     hypertrophy (BPH). Metformin is the treatment of choice in patients with metabolic syndrome,~     given its low cost and comparable pharmacological effects to the tiazolinedionas (eg~     pioglitazone), decreasing hyperinsulinemia, insulin resistance, concentration of free fatty~     acids and triglycerides, also it produces moderate weight loss, improving the metabolic~     profile triglcerides atherogenic lipid and carbohydrate and delaying the onset of diabetes~     mellitus in individuals with impaired fasting glucose.~      A second option for risk reduction would be the addition of inulin fiber type as it has been~     demonstrated some metabolic effects on benefices lipid metabolism and carbohydrate.~      It is expected that combination of metformin with inulin produce a beneficial effect through~     farmacological synergism and the impact on fisiopatological changes of metabolic syndrome~     that potentially is considered as an important risk factor for prostate growth.~   "
60208|NCT02778763|"~     Double blind, randomized, placebo-controlled, multicenter pilot study on efficacy and safety~     of CBLB612 following single administration for neutropenia prophylaxis in breast cancer~     patients receiving doxorubicin and cyclophosphamide myelosuppressive chemotherapy~   "
60209|NCT02778750|"~     Investigators will examine temporal and regional dynamic changes in the microbiome of Cystic~     Fibrosis patients to explore microbiome features that are associated with an inflammatory~     phenotype. Investigators hypothesize that temporal and spatial differences in lung microbiome~     are associated with host inflammatory responses.~      While chronic and polymicrobial airway colonization are commonly recognized in cystic~     fibrosis (CF), it is unclear what factors of the microbial environment lead to infection with~     pathogenic microorganism. This is a multi center, longitudinal cohort of adult Cystic~     Fibrosis subjects recruit4ed from NYU and Columbia to understand how changes in the airway~     microbiome may affect the host inflammatory responses in Cystic Fibrosis (CF). There will be~     three approaches to understanding inflammatory responses; 1) a longitudinal assessment of~     temporal changes in the microbiome over a 6-month period of clinical stability; 2) comparison~     of the regional differences in airway microbiome between lung segments with more versus less~     disease; 3) evaluation of functional aspects of the lung microbiome.~   "
60220|NCT02778607|"~     Progressive Supranuclear Palsy (PSP), Cortico-Basal Degeneration (CBD) and Multiple System~     Atrophy (MSA) are degenerative brain conditions for which there are currently no curative~     treatments. To aid the development of new treatment trials, there is a pressing need to~     develop better methods for diagnosing these conditions early, and to track disease~     progression. The PROSPECT-M-UK study will collect standardised clinical data over time.~     Patients will also have the option to have a brain MRI scan, eye movement exam and donate~     blood, skin and spinal fluid samples, with the aim to identify biomarkers that can improve~     the accuracy of early diagnosis and track the natural time course of disease. Control~     participants and those not meeting criteria for Parkinson's disease or other defined~     conditions but are considered by the investigator group to be allied syndromes or at risk~     states (atypical parkinsonian syndromes), will also be examined. Patients can also~     participate via the CBD European registry or in a one-off study assessment through the~     cross-sectional study, which involves completing questionnaires and a blood sample donation.~   "
60221|NCT02778594|"~     The purpose of this study is to determine the effect of three single oral doses of nebicapone~     (50 mg, 100 mg and 200 mg) on the levodopa pharmacokinetics when administered in combination~     with a single-dose of controlled release levodopa 100 mg/benserazide 25 mg (Madopar® HBS~     125).~   "
60210|NCT02778737|"~     Chronic pain is a long-term condition which is related to a number of negative consequences~     including reduced productivity at work, increased number of sick leave , depression and~     emotional difficulties among others. Psychological interventions, particular Cognitive~     Behavioral therapies (CBT) are deemed effective in reducing the negative consequences~     following a diagnosis of a chronic pain condition. Though research provides substantial~     evidence for the CBT effectiveness, not all patients manage to reduce pain intensity or~     improve their physical and psychosocial functioning. Also, CBT appears with only small effect~     sizes on variables considered to be core domains in chronic pain. Finally, there are~     criticism targets on the lack of clear mechanisms underlying the process of change in CBT.~      New CBT therapeutic approaches, such as Acceptance and Commitment Therapy (ACT) focus on~     changing individuals' relation with their inner experiences. They utilize mindfulness and~     acceptance processes, instead of directly changing or controlling the content of internal~     experiences, as CBT does. ACT has received support for its effectiveness in chronic pain but~     there are very few clinical randomized trials to compare it with traditional CBT.~      The purpose of this study is to determine whether an ACT-based intervention when compared~     with a CBT-based intervention designed for chronic pain patients is efficacious in reducing~     pain interference, pain-related disability, and psychological distress. Also this study aims~     to examine whether any therapeutic effects result due to the effect of acceptance, for those~     participating in the ACT group or control appraisal, for those participating in the CBT~     group. Better knowledge of the mechanism of therapeutic change can help us to recognize which~     patients can be benefit from which approach.~   "
60211|NCT02778724|"~     Rigorous clinical practice assessment is a key factor to improve patient's care and prognosis~     in interventional cardiology (IC). A multicentric IC observational study (CRAC), fully~     integrated to usual coronary activity report software, started in Centre Val de Loire (CVL)~     region in 2014.~      CRAC observatory was conduced on five IC CathLab of CVL region. Quality of collected data is~     regularly evaluated and allowed building an exhaustive, and reliable database. This solution~     could easily be developed in other French regions.~   "
60212|NCT02778711|"~     The purpose of this study is to assess the efficacy of anti-IL 17 treatment (secukinumab) in~     patients with known severe allergic contact dermatitis (ACD).~   "
60213|NCT02778698|"~     This expanded access protocol is for children that cannot get enough nutrients from food and~     must receive nutrition through a vein. The standard nutrition given through a vein is blend~     that has soybean fat. If this is given over a long period of time, it can cause problems. It~     can lead to severe and/or permanent injury to the liver.~      It is believed that a type of fish oil blend, called Omegaven®, may be used in place of the~     soybean fat blend. The Omegaven® fish oil blend may greatly reduce the risk of liver injury.~      Omegaven® is not approved by the Food and Drug Administration (FDA). It is only offered under~     an expanded access protocol as an alternative to the soybean fat blend.~   "
60214|NCT02778685|"~     This phase II trial studies how well pembrolizumab works when given together with letrozole~     and palbociclib in treating postmenopausal patients with newly diagnosed stage IV estrogen~     receptor positive breast cancer that has spread to other parts of the body. Monoclonal~     antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and~     spread. Estrogen can cause the growth of breast cancer cells. Antihormone therapy, such as~     letrozole, may lessen the amount of estrogen made by the body. Palbociclib may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving~     pembrolizumab, letrozole, and palbociclib may be an effective treatment for patients with~     stage IV estrogen receptor positive breast cancer.~   "
60215|NCT02778672|"~     This is a study of up to 275 participants from birth to 12 months who are having a chest~     x-ray while a patient at the Queen Elizabeth Central Hospital in Blantyre, Malawi.~     Participants will have thermal pictures of their chest taken by trained study staff using a~     Smartphone and a FLIR ONE attachment. Thermal images will be read by trained study staff to~     determine if bacterial pneumonia is present. Results of the thermal images will then be~     compared to the results of the chest X-ray. If additional images of the chest are available,~     additional thermal images will be taken of the same location within 24 hours of the other~     image.~   "
60216|NCT02778659|"~     This study aims to determine the effect of acute hypnotic intake (Zolpidem) on sleep,~     cognitive and motor performances and on acute mountain sickness symptoms at high altitude.~     Healthy subjects will be evaluated on 4 occasions (twice at sea level and twice at high~     altitude), after hypnotic or placebo intake. Following an early wake-up (01:00), symptoms,~     cognitive and motor performances will be assessed to determine potential residual effects of~     Zolpidem within such conditions.~   "
60217|NCT02778646|"~     Familial hypercholesterolaemia (FH) is an autosomal dominant somatic mutation commonly~     located on the LDL-receptor, APOB, and PCKS9 gene. The estimated prevalence of homozygous FH~     is estimated at 1 in a million, whereas the prevalence of heterozygous FH ranges from~     1/500-1/200 (0.2-0.5%) of the general population. The majority of individuals suffering from~     FH remain undiagnosed and without treatment. Using preexisting clinical guidelines, this~     study scored patients within national cardiovascular disease (CVD) registries for FH with the~     aim of evaluating prevalence of FH among individuals suffering from premature cardiac events~     within the UK.~      Following scoring of the registry, this study also examined the relationship between~     cholesterol and survival after a premature event in order to understand the possible~     ramifications of untreated FH on patient survival.~   "
60218|NCT02778633|"~     The purpose of this study is to determine fluid responsiveness in critically ill patients by~     measuring mean systemic filling pressure on the intensive care unit.~   "
60219|NCT02778620|"~     The purpose of this study is to determine fluid responsiveness in critically ill patients by~     measuring mean systemic filling pressure on the intensive care unit.~   "
60222|NCT02778581|"~     The aim of the study is to evaluate the beneficial effect of a mixture of vegetal oils with a~     composition related to short, medium and long unsaturated chain fatty acids on patients with~     a diagnose of cognitive impairment or mild to moderate Alzheimer disease~   "
60223|NCT02778568|"~     The aim of this study was to analyze the effects of resistance exercise and training on~     cardiovascular function of peripheral artery disease patients.~   "
60224|NCT02778555|"~     This study sought to develop and validate a brief, daily version of the Pain Catastrophizing~     Scale.~   "
60226|NCT02778529|"~     This study is being performed to assess how certain chronic disabilities - stroke, upper~     extremity (UE) amputation, spinal cord injuries (SCI), cerebral palsy (CP) - differ from~     healthy subjects in their ability to perform ADLs. By studying the kinematics of the~     respective cohort of study participants as they are assessed performing common activities of~     daily living (ADLS), the investigators research team aims to better understand how impaired~     neural pathways, and pathways that have been impaired at various points along the pathway,~     deleteriously affect ADLs in patients with differing long-term disabilities.~   "
60227|NCT02778516|"~     Dietary sodium intake independently increases the risk of mortality in end stage renal~     disease (ESRD). It plays a significant role in hypertension, hypervolemia, and left~     ventricular hypertrophy (LVH), and blunts the effectiveness of hypertensive agents. In~     addition, the hypervolemia associated with excessive dietary sodium intake results in the~     need for more intense fluid removal during dialysis (ultrafiltration), resulting in symptoms~     such as pain, cramps, hypotension, nausea, and vomiting during hemodialysis (HD) treatment~     sessions. Although sodium restriction is a universal recommendation for ESRD management, the~     National Kidney Foundation (NKF) recommendation of 2400 mg/day is consensus-based per the~     Dietary Approaches to Stop Hypertension (DASH) studies, not an evidence-based recommendation~     from data derived from a dialysis population. In addition, The Dietary Guidelines for~     Americans 2010, recommend further restriction of dietary sodium intake to 1500 mg per day for~     persons with hypertension and/or kidney disease, middle-aged and older adults, and African~     Americans, though there is also little empiric evidence to support this recommendation in the~     general population and none in the dialysis population. Therefore, it remains to be~     demonstrated that a diet with such sodium restrictions is attainable, sustainable, safe or~     beneficial. The investigators propose a double blind randomized controlled design~     investigation to examine the feasibility of assessing the effects of three levels of sodium~     intake (ambient, 2400 mg/d, 1500 mg/d) on the hemodialysis (HD) participant symptom profile,~     and to compare the effect of hemodialysis-specific variables on participant symptom profile~     during dialysis as well as to explore the role of body fluid composition using bioimpedance~     (BIA) measurements among the three sodium-restricted groups as a marker of sodium restriction~     efficacy.~   "
60228|NCT02778503|"~     Atraumatic Restorative Treatment (ART) is an alternative restorative technique for dental~     caries, applying the partial caries tissue removal philosophy using hand instruments,~     relative cotton rolls isolation, immediate restoration with Glass Ionomer Cements (GIC) and~     avoiding local anesthesia. The chosen material for this study will be the High Viscosity~     Glass Ionomer Cement (HVGIC) due to its unique physical-chemical properties as well as its~     applicability in challenging clinical situations where other materials would not be adequate.~     Although there are substantial evidences regarding GIC properties, information about GIC~     (with different costs) longevity is still weak. Therefore, the objective of this study is to~     assess the effectiveness of ART restorations performed with low-cost HVGIC in cavitated~     dentine carious lesions in primary and permanent molars. This will be a multicenter~     randomized controlled double-blind (patient and operator) clinical trial performed with 680~     primary and/or permanent molars in children between 4 and 9 years old presenting cavitated~     dentine carious lesions in occlusal and occlusal-proximal surfaces. The tooth will be~     considered as the unit sample, which will be randomly allocated to the groups through a~     generated random list numbers and distributed in dark sealed envelopes opened only by dental~     assistants. Teeth in the test group will be submitted to restorative treatment with HVGIC~     Vitro Molar and those in the control group with HVGIC Fuji IX. The restoration effectiveness~     will be assessed by means of both clinical and bitewing x-rays control after 6 and 12 months.~   "
60229|NCT02778490|"~     In this pre-post observational study, the investigators will enroll and follow a cohort of~     about 50 adults undergoing sleeve gastrectomy surgery for weight loss. Pre-operatively and at~     6 and 12 months post-operatively, the investigators will use state-of-the-art metabolic and~     imaging techniques to evaluate calcium metabolism and skeletal health. Specific outcomes~     include intestinal calcium absorption capacity, bone mineral density (BMD) assessed by~     dual-energy X-ray absorptiometry (DXA) and quantitative computed tomography (QCT), and bone~     structure assessed by QCT and high-resolution peripheral QCT (HR-pQCT).~   "
60230|NCT02778477|"~     The current study is the first clinical trial proposed with PF-06423264. It is designed to~     evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of~     multiple ascending doses of PF-06423264 to healthy adult subjects with or without oily skin.~   "
60231|NCT02778464|"~     When women with rheumatoid arthritis become pregnant 75% of them will go into remission,~     despite stopping medication. This phenomenon is not well understood and is not seen in other~     inflammatory conditions. Once they give birth they often relapse. Bacteria in the stool and~     inside the gut have the ability to effect the immune system and some beneficial bacteria are~     known to down regulate inflammatory components of the immune system. Gut bacteria are also~     known to alter significantly during pregnancy and in other inflammatory conditions there are~     low levels of beneficial bacteria associated with diseases like ulcerative colitis. There is~     significant crossover between rheumatoid arthritis and inflammatory bowel disease with~     similar arthritic symptoms and mechanisms of inflammation. There is very limited~     investigation of gut bacteria and rheumatoid arthritis, but some animal work has shown that~     treatment with probiotics and prebiotics can improve the condition. The aim of this study is~     to examine the bacteria in the stool of women who are pregnant with rheumatoid arthritis and~     identify any significant bacteria changes that might be used to direct future research.~   "
60232|NCT02778451|"~     Ultrasonography (US) is an operator depended image modality that is difficult to reproduce~     and interpret by others. Competence of the US operator is crucial for reliable diagnostics~     but no evidence-based certification of head and neck US skills has been developed.~     Investigators conducted an experimental study aimed to explore diagnostic accuracy and~     establish validity evidence for certification standards in surgeon-performed ultrasonography.~   "
60233|NCT02778438|"~     REINVENT is a non-interventional, multi-center, research network-based cross-over study~     evaluating the potential utility of a telehealth platform in improving the efficiency of~     clinical trials. The study aims to enroll 30 subjects from primary care practices coordinated~     through a single main study site. Potential subjects will be screened and randomized (1:1) at~     Visit 1 into a 2-period crossover design study where 4 standard cognitive outcome measures~     are administered at Visits 2 (Day 30 ±7) and 3 (Day 90 ±7), either remotely or during an~     in-person visit.~   "
60234|NCT02778425|"~     This study compare the efficiency of partial splenic embolization +endoscopical therapy with~     endoscopical therapy alone in gastroesophageal variceal haemorrhage accompanied with~     splenomegaly or hypersplenism of hepatocirrhosis and portal hypertension treatment.~   "
60308|NCT02777463|"~     To investigate the correlation between pretreatment ADC value of diffusion MRI and pathologic~     response in patients with borderline resectable pancreatic carcinoma who undergo neoadjuvant~     therapy.~   "
60235|NCT02778412|"~     When the DNA inside of human cells undergoes certain alterations (mutations), the cells may~     develop into a cancer. The cancer cells may shed this DNA into the blood stream. This~     circulating tumor DNA (ctDNA) can be detected by very sensitive, specialized laboratory~     tests. Measurement of ctDNA has been shown to be useful for following patients with known~     cancer. The purpose of this study is to examine blood specimens for the presence of ctDNA in~     individuals without known cancer who are scheduled to undergo a fine needle aspiration biopsy~     of the thyroid gland because of one or more thyroid nodules in order to see if the ctDNA test~     can detect a cancer at a very early stage. The results of this study should help define the~     role of ctDNA in the detection of early stage thyroid cancer and to define how sensitive it~     is (i.e. how well it picks up cancer when it is present) and how specific it is (i.e. how~     often is ctDNA found in patients with benign thyroid nodules).~   "
60236|NCT02778399|"~     The primary objective of this study is to assess the efficacy and safety of a range of oral~     doses of OBE2109 versus placebo, in reducing endometriosis associated pain.~   "
60237|NCT02778386|"~     This Phase I evaluation of N-MCT in normal volunteers requires sequentially increased doses.~     At each dose level, the safety and pharmacokinetic will be measured. This Phase I trial will~     have the dose range of N-MCT from 200mg - 1200mg per patient.~   "
60238|NCT02778373|"~     This study sought to examine differences in resistance exercise performance, as measured by~     the kinetic and kinematic profile during multiple sets of the back squat exercise, following~     ingestion of high or low molecular weight carbohydrate beverages.~   "
60239|NCT02778360|"~     The main objective of the study is to demonstrate the non-inferiority of the personalized~     Neurofeedback Training device versus Methylphenidate in the treatment of children and~     adolescents with Attention-Deficit/Hyperactivity Disorder.~   "
60240|NCT02778347|"~     The purpose of this study is to develop and validate a comprehensive and standardised tool~     for assessment of patient needs in palliative care.~   "
60241|NCT02778334|"~     Introduction and literature review With 130 000 cases per year in France in 2010, stroke is~     one of the most common neurological diseases, often leaving many disabling sequelae physical~     and cognitive levels (currently live 500 000 disabled following a stroke) and leading and a~     loss of significant autonomy in these patients. However, many stroke survivors soon find a~     range comparable to their previous state. Investigators can then ask ourselves about the~     impact of this life event in these people who apparently do not show visible effects: what~     about the psychological repercussions of stroke in these patients healthy; what is changed in~     their daily lives, particularly in their mental functioning after this brutal confrontation~     with their own mortality?~      Objectives Our project aims to better understand the psychological repercussions of stroke in~     patients who quickly find a health and autonomy comparable to their previous state. The~     objective will be to investigate the relationship between depressive symptoms and anxiety,~     coping strategies and quality of life from the acute phase and during the first months after~     the onset of stroke. This period is particularly demanding for these patients must therefore~     adapt and readjust continuously: shock stroke, hospitalization in several services (intensive~     care, neurology, rehabilitation), back home, new life with the changes related stroke,~     resumption of a professional activity, etc ...~      Our methodology will combine tools conventionally used (standardized interview, validated~     questionnaires) to newer, ecological and true methods (Experience Sampling Method applied by~     the use of a smarphone application) to assess different variables studied.~      This initially be determined whether the various symptoms of the depression on the one hand~     and anxiety on the other hand, depending on their mode of expression (vs. outsourced~     internalized; ie emotional, cognitive, somatic), observed from the acute phase of stroke, are~     related and predict the quality of life, depression and anxiety in the longer term (four~     months after the stroke).~      Furthermore, our study will observe if the individual coping strategies (coping) daily and~     evolution influence the psychological status and quality of life during the months following~     the stroke.~   "
60242|NCT02778321|"~     Cerebral infarction (CI) can be linked to atherosclerosis of large vessels, occlusion of~     small vessels intracerebral (gaps), a cardioembolic disease or other rare causes. However, up~     to 40% of CI remains unexplained after a thorough diagnostic workup. They are called~     cryptogenic IC.~      Atrial fibrillation (AF) is the cause of 25% of the CI but it is recognized that episodes of~     paroxysmal AF, asymptomatic and unnoticed, may be responsible for a portion of the IC~     cryptogenic pace. Recognition of these episodes is of great importance since they have the~     same risk embolic the FA continues [1, 2] and motivate anticoagulant therapy startup.~      Several recording techniques heart rate were evaluated after the IC for detecting the AF.~     Their profitability increases with the duration of the recording: about 3% for a typical~     24-hour Holter, the AF detection rate increases to 6% for a 7-day surveillance period, to~     12-23% for 30 days and 17-26% with implantable recorders long.~      Otherwise brief rhythmic heart abnormalities can be detected with the waning of an CI without~     the significance of these episodes is known.~      Investigators decided to conduct this study because there is no prospective study of good~     quality with a sufficient number of patients that evaluated the interest of a non-invasive~     recording of long duration. The only randomized CRYSTAL AF is used for invasive subcutaneous~     implantable monitor (Reveal XT).~      To clarify the significance of arrhythmias and because the presence of several causes is~     common after 65, investigators propose to record all patients hospitalized for HF.~   "
60243|NCT02778308|"~     Carcinoma of the gallbladder is the commonest malignancy of the biliary tract. Higher~     incidence has been noted in Chile, Mexico and Southwest American Indians.[1] It is the third~     most common malignancy in India.[2] The disease may mimic benign disease in presentation.Up~     to 1/3rd of patients may present with jaundice but of these only 7% will be resectable.[4]~     With aggressive surgical resection, actuarial 5 year survival of 83% for stage II disease and~     63% for stage III have been reported.[5] Treatment of choice is complete surgical resection.~      The role of chemotherapy and radiotherapy is not very well documented in treatment of~     gallbladder cancer. Because of the propensity of gallbladder carcinoma to spread to regional~     lymph nodes at an early stage and the high rate of loco regional recurrence, adjuvant~     chemotherapy or chemo-radiotherapy seems a rational therapeutic option. Gemcitabine with or~     without Cisplatin has been increasingly used. In a recent paper Gemcitabine with Cisplatin~     was found to be more effective than gemcitabine alone and provides definite survival~     advantage and progression free survival.[6] An earlier randomized trial done to assess the~     efficacy of the adjuvant chemotherapy for the pancreato-biliary cancer reported improvement~     in disease free and overall 5 year survival.[7] But this study has included patients with~     suboptimal resection and all pancreato-biliary malignancy.~      In view of these observations this study is being designed to assess the efficacy of the~     chemotherapy in the adjuvant setting in gallbladder cancer patients who have undergone~     curative resections.~   "
60244|NCT02778295|"~     Development of a new MS-based biomarker for the early and sensitive diagnosis of a Fabry~     disease from plasma~   "
72871|NCT02613130|"~     This study will assess changes in oral malodor and other factors in response to using a~     two-step toothpaste oral hygiene relative to a sensitivity whitening toothpaste.~   "
60246|NCT02778269|"~     Patients with insulin-dependent diabetes mellitus (DM) and chronic kidney disease (CKD)~     exhibit an excessive risk for cardiac arrhythmias, in particular sudden cardiac death (SCD).~     Various studies have shown that hypoglycemic episodes are strong predictors of cardiovascular~     mortality in both type 1 and type 2 diabetic patients. Experimental data and small clinical~     studies link hypoglycemia with ECG changes and SCD, but little is known about the direct~     association of hypoglycemic events and/or rapid swings in blood glucose with arrhythmias in~     this high risk population. Ideally, an algorithm should help to identify patients at risk for~     hypoglycemia-associated arrhythmias and SCD, but hitherto systematic analyses of blood~     glucose values and 12-channel ECGs are lacking in these patients.~      In this validation study a 12-lead ECG T-shirt consisting of textile electrodes and a data~     logging device wich can record long-term 12-lead ECG data will be tested. The purpose of the~     T-shirt is to improve the patient's comfort for long-term recordings and to prevent adverse~     effects of regular ECG electrodes. Current systems are limited by the use of ECG electrodes~     involving disadvantages like severe direct side effects on the skin such as rash and bullous~     lesions as well as slipping electrodes. By the means of the proposed ECG T-shirt those~     drawbacks will be avoided.~   "
60247|NCT02778256|"~     Vestibular stimulation has been shown to be a very effective noninvasive treatment for major~     depression. Bipolar disorder is a mental illness that presents cyclic sequences of depressive~     and euphoric states. Depressive phases of bipolar disorder are difficult to treat and usually~     are resistant to actual available treatments. This study investigates the effectiveness of a~     particular technique of vestibular stimulation in a group of 120 bipolar type I and II~     patients. After randomization 60 of them will receive specific vestibular stimulation~     (experimental group) and 60 will receive a sham vestibular stimulation.The study will~     conducted in Vest Brain, Centro de Estudios Neurovestibulares, in Chile.~   "
60248|NCT02778243|"~     Patients followed in the Foch Hospital Urology Department (Suresnes): Patients justifying a~     prostatectomy.~        -  Patients justifying prostatectomy together with the bladder (radical cystectomy for~          bladder cancer).~        -  Patients with benign prostate hyperplasia who justified a prostatectomy. Compare serum~          sexual steroid concentrations and intra-tissue on healthy prostates and prostate~          adenoma, assess concentrations intra-tissue sex steroids on cancer metastasis prostate~          specific blood sample under study (30mL) will be performed preoperatively in Patients~          followed in Foch Hospital Urology Department (Suresnes), and a Removal of a fragment of~          prostate tissue or metastasis will be analyze.~      Aim is to compare serum concentrations of sexual steroids and intra-tissue on healthy~     prostates and prostate adenomas compared to concentrations measured in patients operated for~     prostate cancer.~   "
60249|NCT02778230|"~     The purpose of this randomized, cross-over study is to explore the effects of pea hull fiber~     on bowel movement frequency, transit time, appetite, gastrointestinal symptoms, microbiota~     composition and activity.~   "
60250|NCT02778217|"~     Culture media used to support development of zygotes to the blastocyst stage is based on two~     basic philosophies: a single step medium let-the-embryo-choose or a sequential medium~     back-to-nature.~      For single step media, there are two types of protocol can be used for the culture of human~     preimplantation embryos:~        1. Interrupted single medium culture, in which the medium is renewed on the Day 3 of embryo~          culture~        2. Uninterrupted single embryo culture, in which the same single medium is used throughout~          the 5-6 days of culture with no replenishment or replacement on Day 3.~      Investigators aim to compare the blastocyst development and clinical outcome between the two~     types of protocols of a single medium (with or without renewal on Day 3)~   "
60251|NCT02778204|"~     This study will evaluate the safety, tolerability, and pharmacokinetics of maraviroc in~     infants at risk for mother-to-child HIV transmission and determine an appropriate dose of~     maraviroc during the first 6 weeks of life.~   "
60252|NCT02778191|"~     Concomitant chemoradiotherapy improves overall survival in patients with locally advanced~     head and neck squamous cell carcinoma (LA-HNSCC) compared to radiotherapy alone. Cisplatin~     100 mg/m2 at day 1, 22 and 43 is widely used but results in considerable acute and late~     toxicity. Three cycles of carboplatin plus 5-fluorouracil (5-FU) is an accepted alternative~     but both chemotherapy regimens have not been compared prospectively. The aim of this study is~     to compare tolerability, efficacy, toxicity and quality of life in patients with LA-HNSCC~     treated with concomitant cisplatin and carboplatin plus 5-FU.~   "
60253|NCT02778178|"~     Anterior Lumbar Interbody Fusion (ALIF) as well as Direct Lateral Interbody Fusion (DLIF) are~     established techniques for lumbar interbody fusion. In contrast with posterior approaches,~     they allow free approach to the anterior disc space without opening of the spinal canal or~     the neural foramina. However, the additional anterior approach conveys specific concerns,~     including abdominal pain that may delay recovery after surgery. The transversus abdominis~     plane (TAP) block is a validated approach for postoperative pain relief following abdominal~     surgeries. There is currently no evidence of the possible benefits of TAP block as part of~     multimodal pain management after ALIF/DLIF surgery. The investigator hypothesize that a~     single-injection TAP block reduces opioid consumption after anterior lumbar fusion surgery.~     The main goal of this prospective, randomized, double-blind, placebo-controlled study is to~     demonstrate a >35% reduction in opioid consumption during the 24h following ALIF/DLIF~     surgery.~   "
60254|NCT02778165|"~     MyCardiacRecovery (MyCaRe) is an interactive platform that includes a standardized~     educational format and interactive tracking (wound healing and activity progression using~     photo capabilities and Fitbit flex accelerometer) support during the first 6 to 8 weeks post~     hospital discharge. This application will help patients and family navigate their way through~     the continuum of care by providing an: a) integrated link between acute care and outpatient~     cardiac rehab for efficient coordination of information and reduction in duplication of~     services; b) patient care and education materials designed to address salient recovery~     questions; c) improved communication between the patient and care providers and, d) ensure~     streamlined systematic referral to CR. This innovative strategy has the potential to~     positively impact patient satisfaction, improve patient outcomes and possibly minimize~     financial constraints placed on the health care system. Phase 1 (preliminary usability~     testing) of prototype 1.0 is complete. Phase 2 will focus on testing MyCaRe 2.0 in a sample~     of post cardiac surgery patients using a pilot randomized controlled trial (RCT) design.~   "
60257|NCT02778126|"~     The main purpose of this study is to evaluate the safety of the study drug known as LY2606368~     in participants with advanced cancer or cancer that has spread to other parts of the body.~     This study will involve a single dose of ¹⁴C radiolabelled LY2606368. This means that a~     radioactive substance, carbon 14, will be incorporated into the study drug. This will provide~     information about the study drug and its breakdown products and will help determine how much~     passes from the blood into urine, feces and expired air. After a minimum 14-day washout~     period following the [¹⁴C] LY2606368 dose, participants will be allowed to receive continued~     access to LY2606368 as outpatients.~   "
60258|NCT02778113|"~     The main purpose of this study is to evaluate the safety and tolerability of LY900018. The~     study drug will be delivered into participant's nostril (intranasally) or will be given as an~     injection just under the skin (subcutaneously) once in each of four study periods. The study~     will last about 23 days for each participant.~   "
60259|NCT02778100|"~     The main purpose of this study is to evaluate the safety of LY900018 in participants with a~     common cold, some of whom will also take a nasal decongestant. The study will investigate how~     the body processes LY900018 and the effect of LY900018 on the body. The study will last up to~     30 days for each participant.~   "
60260|NCT02778087|"~     It has been suggested that augmenting repetitive task practice with the use of box (mirror)~     therapy (BT) can enhance the benefits of task practice and may provide stroke survivors an~     opportunity to engage in self-directed practice outside of normally scheduled therapy~     sessions. However, the dosage of BT to be used in clinical practice is unclear. In order for~     practitioners to begin integrating BT into clinical practice situations more information is~     needed to determine what defines a therapeutic dose. The aim of this study is to~     differentiate between two dosages of self-directed BT added to treatment as usual for~     decreasing arm and hand motor impairments, improving activity level, and increasing~     self-directed participation after stroke. Forty-five subjects from the Stroke Rehabilitation~     Unit at Helen Hayes Hospital (HHH) will be randomly assigned into three groups: treatment as~     usual plus 30 minute dosage of self-directed BT 5x/week; treatment as usual plus 60 minute~     dosage of self-directed BT 5x/week; treatment as usual plus 30 minutes of self-directed sham~     BT 5x/week.~   "
60261|NCT02778074|"~     Purpose and aims Tailored internet-based cognitive behavioural therapy (I-CBT) is a new~     innovative and person-centred method that is promising that may be used to decrease~     depression in patients with cardiovascular disease (CVD). In patients with CVD, depressive~     symptoms is a common co-morbidity leading to decreased wellbeing, and increased morbidity and~     mortality. Depressive symptoms are both underdiagnosed and undertreated in CVD patients.~     Earlier studies have demonstrated the efficiency of cognitive behavioural therapy (CBT) for~     many psychiatric conditions, but few studies have evaluated CBT in patients with CVD.~      The purpose of this study is to evaluate the effects of the tailored I-CBT program on~     reducing depressive symptoms and other patient reported outcomes in patients with~     cardiovascular disease (CVD) and to explore factors related to implementation of the I-CBT~     program in clinical cardiac care.~      Aims of the study~        -  To evaluate the effects of the tailored I-CBT depression program on depressive symptoms,~          sleep, anxiety and quality of life.~        -  To evaluate factors that can influence the I-CBT programs effect on depressive symptoms.~        -  To gain knowledge about the I-CBT program, as perceived by patients and health care~          professionals.~        -  To explore facilitators and barriers to the implementation of the I-CBT program in~          clinical practice from the perspectives of patients, health care professionals and~          policymakers.~   "
60262|NCT02778061|"~     Participating investigators will locate all IUB B insertions conducted at their facility at~     least 12 month prior the initiation of study data collection. The study is composed of 2~     parts. Part one is collecting data out of patient's medical record which is accessible only~     to the doctor. This data is mostly demographic. Part two of the study comprises a phone call~     to the patients done by the doctor or by authorized site personnel. In the phone call the~     study purpose will be explained to the patient and a patient consent will be required. After~     the patients consent to participate, the doctor will ask the patient the questions defined in~     the study protocol regarding her experience during the time since the IUB SCu300B's~     insertion.~      A total of 200 eligible subjects will be invited to participate in the study. Informed~     Consent Form will be signed and sent to the investigator, applicable CRFs will be completed~     by the investigator or authorized site personnel. The patient questionnaires will be asked on~     the telephone and entered directly into the CRF by the investigator or authorized site staff~     (CRF = source document). Also the physician´s questionnaire will be directly completed in the~     CRF by the investigator (CRF = source document). All other clinical data will be transcribed~     to the CRF from the medical patient records (patient records = source document).~      There are no planned patient visits to the doctor's office for study purposes. If the patient~     visits the physician´s office as part of the clinical routine, the study procedures can also~     be performed directly at the site instead of telephone contacts.~   "
60263|NCT02778048|"~     With the project Smart Muscle for Incontinence Treatment (SMIT) a multidisciplinary~     consortium consisting of representatives ranging from clinical medicine via microelectronics~     towards biomaterial science aims to develop a novel implant to treat faecal incontinence. The~     aim of this campaign includes development of implantable prototype devices acting as~     artificial continence muscles using low-voltage electrically activated polymers (EAPs)~     controlled by implemented pressure sensors and the patient.~      Subsequently, the knowledge of the anatomical and biomechanical properties of the anal~     sphincter complex are of cardinal importance. Most of the existing data on anatomy and~     physiology results is based on old studies and almost no data on biomechanical properties are~     available. However, new technologies or even merging data from different examination methods~     might provide new information in this field.~   "
60264|NCT02778035|"~     This trial will compare the trajectories of improvement for three different patterns of~     twice-daily rTMS in major depression: two daily sessions of dorsomedial prefrontal rTMS~     delivered at 0 min vs. 30 min vs. 60 min intervals.~   "
60265|NCT02778022|"~     The purpose of this study is to evaluate the effectiveness of PriCARE in decreasing child~     behavior problems and improving parenting capacity and skills at 2 primary care clinics in~     Philadelphia.~   "
60266|NCT02778009|"~     Using FitBit activity monitors, physical activity levels will be monitored in first year~     medical students. Body Composition will be measured as well.~   "
60267|NCT02777996|"~     ITALUNG is a RCT for the evaluation of the efficacy of lung cancer screening with low-dose~     Computer Tomography (LDCT) , carried out in three screening centers in Florence, Pisa and~     Pistoia districts of the Tuscany region of Italy.~      3106 high risk subjects (age 55-69, smokers or ex-smokers) were recruited and randomized to~     the Active arm (Baseline + 3 annually repeated LDCT screening) or to the Passive arm,~     followed up in usual care (no screening reccomended ) All subjects were invited, if smokers,~     to consider smoking cessation practice. Follow-up for cause specific mortality and overall~     mortality and for lung cancer incidence was performed (actually at 9.3 years since~     randomization) . Blood and sputum samples were stored from the Active arm in a Biobank, with~     1304 subjects enrolled in the Italung Biomarker study.~   "
60268|NCT02777983|"~     The purpose of this project is to measure the impact of a short educational session on~     outcomes for patients consulting in primary care for low back pain. Subjects will be patients~     consulting to their primary care provider for a primary complaint and new episode of low back~     pain. Subjects will be randomized to receiving the educational tool versus usual care~     (information only without an educational component) in the clinic immediately prior to seeing~     their PCP. Patients will be followed for a 6-month period, and outcome measures will be~     collected and compared across both groups.~   "
60269|NCT02777970|"~     The study is aimed to evaluate the analgesic efficacy of TRAM.HCl/DKP.TRIS 75mg/25mg oral~     fixed drug combination in comparison with TRAM.HCl /paracetamol 75mg/650mg in the treatment~     of moderate to severe acute pain.~   "
60270|NCT02777957|"~     First, the aim of the study was to evaluate the usefulness of echocardiographic parameters~     for detecting pulmonary hypertension (PH) in patients with advanced lung disease referred for~     lung transplantation. Second, to assess the prevalence of PH and to identify which~     hemodynamic, echocardiographic, pulmonary functional test, exercise capacity and biochemical~     parameters (especially NT-proBNP) have an impact on survival in a cohort of patients with~     severe lung diseases referred for lung transplantation.~   "
60271|NCT02777944|"~     The aim of this study is to test whether MotivATE can increase attendance at assessment. This~     will be done using a single-consent Zelen randomised control trial, with all non-emergency~     adult clients referred to the Kimmeridge Courte Eating Disorder Service over a one year~     period being randomised to either treatment as usual (TAU) or TAU plus access to the MotivATE~     intervention prior to their assessment appointment.~   "
60272|NCT02777931|"~     This is a randomized, double-blind, placebo-controlled, parallel-group study of NFC-1 versus~     placebo in adolescents with ADHD who have genetic disorders impacting mGluRs.~   "
60273|NCT02777918|"~     This is an intervention study, aiming to increase protein intake, by increasing egg~     consumption in community dwelling older adults aged 55 years and over, by providing recipes~     to increase flavour and variety in egg dishes.~   "
60274|NCT02777905|"~     About 10-20% of older patients in primary care suffer from symptoms of depression and/or~     anxiety. Depression and anxiety are associated with higher rates of cognitive decline, lower~     quality of life, increased medical comorbidity, and higher mortality rates in these patients.~     Given the world's aging population and consequent rapid increase in older patients in primary~     care, many traditional therapeutic approaches for depression or anxiety in this patient~     population - e.g. assessment by a mental health practitioner, individual psychotherapy and/or~     appropriate psychotropic medication - have been inadequate, with many patients having~     undetected depression and anxiety. Additionally, geriatric depression and anxiety are very~     common, but difficult to treat with psychotropic medications: patients are more sensitive to~     adverse effects and respond relatively less well to medication.~      To help with this issue, the investigators are conducting a randomized controlled trial of~     mindfulness-based cognitive therapy (MBCT), a treatment that has been highly effective in~     treating depression and anxiety, but has not yet been assessed in older adults. There has~     been relatively little information about MBCT's effectiveness, particularly in the primary~     care setting and in the acute treatment of depression and anxiety(vs. maintenance treatment).~      This study will be conducted in 75-100 older adults in primary care with symptoms of anxiety~     and depression. The study will take place in the centre local de services communautaires~     CLSC Benny Farm, a primary health care centre in Montreal, Canada. Most patients aged 60+~     with symptoms of depression (Patient Health Questionnaire 9 (PHQ-9) score ≥10) or anxiety~     (General Anxiety Disorder-7 (GAD- 7) score ≥10) will be eligible. Patients who are eligible~     for the study will be randomized: half the patients will get 8-week MBCT with a trained~     interventionist (occupational therapist, psychiatry resident, or psychiatrist). The other~     half (control group) will get patient treatment as usual with patient primary care~     physician/primary care team during the study, but then after the study, patients will be~     offered the treatment if patients would like.~   "
60275|NCT02777892|"~     Multi-center, Observational Registry with Retrospective Enrollment and Prospective Follow-up.~      The aim of the registry is to document the feasibility and safety of implanting an Edwards~     SAPIEN S3 transcatheter heart valve in the pulmonic position~   "
60276|NCT02777879|"~     This is a cross sectional case controlled study to assess lung microbiome and inflammation in~     smokers with and without Chronic Obstructive Pulmonary Disease (COPD). Investigators will~     look at active bacterial metabolic pathways in the lower airways using metagenomic and~     metabolomic approaches an assess relationships among microbiome, metagenome, metabolome and~     host immune responses in COPD and controls. Investigators believe COPD cases will have higher~     prevalence of pneumotype supraglottic predominant taxa (SPT) than matched controls.~   "
60277|NCT02777866|"~     The purpose of this study is to determine if the infiltration of 0.5% Bupivacaine in the~     surgical wound is effective to diminish the pain and the risk of surgical site infections in~     patients who go to a open gastrointestinal procedure.~   "
60278|NCT02777853|"~     The aim of this research is to explore changes in peripheral/cerebrovascular function and~     insulin sensitivity after a 7-day combination of physical activity reduction (-50% steps per~     day) and overfeeding (+50% kcal per day, comprising 65% fat) in healthy male volunteers, and~     examine whether daily intake of tea can prevent such changes.~   "
60279|NCT02777840|"~     High flow oxygen results in better oxygenation in emergency cases needing rapid sequence~     induction for anaesthesia. Secondary outcome measure is time for any desaturation.~   "
60280|NCT02777827|"~     The purpose of this study is to investigate the pharmacodynamics of single doses of~     abediterol given by 2 different devices in participants with asthma. Abediterol (AZD0548) is~     a potential for once daily treatment of asthma and chronic obstructive pulmonary disease~     (COPD) in fixed dose combination (FDC) with an inhaled corticosteroid (ICS) or a novel~     anti-inflammatory agent. The aim of the clinical studies is to enable further investigations~     in participants with asthma and COPD to evaluate and develop abediterol as an effective long~     acting bronchodilator with an acceptable safety profile compared to other inhaled~     bronchodilators on the market, for the treatment of asthma and COPD.~   "
60320|NCT02777307|"~     Demonstrate the effectiveness to Hemopatch in controlling postoperative bleeding or reducing~     of postperative fluid collection after laparoscopic cholecistectomy, morbidity and~     postoperative hospital stay.~   "
60281|NCT02777814|"~     There has been no report on whether the patients with colorectal cancer who are also inactive~     Hepatitis B Carriers should receive Prophylactic Use or preemptive Use of an Anti-viral Drug~     Entecavir. This open, randomized controlled clinical trial aims to compare the impact of the~     prophylactic use or preemptive use of an anti-viral drug Entecavir on the outcomes of~     patients with colorectal cancer who are also inactive hepatitis B carriers during~     chemotherapy and the subsequent follow-ups.~   "
60282|NCT02777801|"~     There has been no report on whether the patients with gastric cancer who are also inactive~     Hepatitis B carriers should receive prophylactic use or preemptive Use of an Anti-viral Drug~     Entecavir. This open, randomized controlled clinical trial aims to compare the impact of the~     prophylactic use or preemptive use of an anti-viral drug Entecavir on the outcomes of~     patients with gastric cancer who are also inactive hepatitis B carriers during chemotherapy~     and the subsequent follow-ups.~   "
60283|NCT02777788|"~     The purpose of this study is to observe the efficacy of chemotherapy combined with Chinese~     patent drugs for patients with advanced non-small-cell lung cancer, also to evaluate the~     adverse reaction and the reliability.~   "
60284|NCT02777775|"~     The purpose of the research study is intended to use specimens (such as tissue) and medical~     information in the Laboratory of Musculoskeletal Oncology at the Van Andel Research Institute~     for laboratory research in Grand Rapids, Michigan. Small tissue samples of cutaneous~     neurofibromas will be collected as part of this research. The samples will help researchers~     learn more about cutaneous neurofibroma and help them better understand NF1. There are many~     different types of studies, both now and in the future, that can be done using the specimens~     they receive. These include using the specimens and information to look for new ways to~     diagnose and treat Neurofibromatosis Type 1 (NF1). The specimens may be used to study how~     genes affect health and disease, or how genes affect the way a disease or condition responds~     to treatment. Some of these studies may lead to new products, such as treatments or tests for~     diseases. Through this study, we hope to find better ways to understand and treat NF1 in the~     future.~   "
60285|NCT02777762|"~     Getting regular physical activity has many health benefits. Current physical activity~     programs often encourage people to track their physical activity as a way to motivate them to~     continue being physically active over time. However, not everyone enjoys physical activity,~     so tracking physical activity may not be very motivating. This research study will evaluate~     whether a new program—specifically designed to enhance people's enjoyment of physical~     activity—improves people's attitudes toward physical activity compared to a program that~     encourages people to track their physical activity with a mobile app.~   "
60286|NCT02777749|"~     The objective of the study is to compare the efficacy of adductor canal blocks versus~     periarticular bupivacaine injections for pain management in total knee arthroplasty. This~     randomized clinical trial will compare outcomes between adductor canal blocks, periarticular~     bupivacaine injections, and periarticular liposomal bupivacaine injections. Results from this~     study will help determine the most appropriate perioperative pain management strategy for~     patients undergoing a total knee arthroplasty.~   "
60287|NCT02777736|"~     Comparison of cumulative incidence of CNS relapses in patients with diffuse large B-cell~     lymphoma with intermediate or high risk of CNS relapse treated with CNS prophylaxis: either~     with 2 doses of intravenous methotrexate 3g/m2 i.v.(arm A) or 6 doses of intrathecal~     methotrexate 12mg (arm B) and in patients with low risk of CNS relapse without CNS~     prophylaxis (arm C).~   "
60288|NCT02777723|"~     The purpose of this study is to compare the efficacy and safety of CKD-350 in patients with~     dry eye syndrome~   "
60289|NCT02777710|"~     Colorectal cancer (CRC) and pancreatic ductal adenocarcinoma (PDAC) are the most common~     gastrointestinal cancers in Western countries and are both associated with significant~     morbidity and mortality. An intriguing similarity between CRC and PDAC is the fact that the~     newly developed immune checkpoint inhibitors, especially PD1/PDL1 inhibitors, seem to have~     limited efficacy as single agents in both of these tumor types. Recent preclinical studies~     point towards alternatively activated (M2-type) macrophages as possible culprits in inducing~     local immune protection from cytotoxic T cells and resistance to PD1/PD-L1 targeted agents.~     We hypothesize that CSF1R blockade will deplete the tumor microenvironment of M2 macrophages,~     thus favoring the induction of a cytotoxic anti-tumor T-cell response following PD-L1~     blockade with an anti-PD-L1 monoclonal antibody. So we propose to conduct a Phase I dose~     escalation study in order to evaluate the safety and clinical activity of a combined~     treatment associating an anti-CSF1R (PEXIDARTINIB) with an anti-PD-L1 (DURVALUMAB) in~     patients with advanced/metastatic colorectal or pancreatic cancers. Dose escalation part will~     determine the Maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of~     Pexidartinib given in combination with Durvalumab. Extension part will evaluate the clinical~     activity of the combination at the RP2D.~   "
60290|NCT02777697|"~     The aim of this study is to investigate the predictive dimension of cognitive-emotional~     status of cancer patients on the chronic pain development 6 months after different cancer~     treatment protocol (surgery, chemotherapy, radiotherapy, hormone therapy, targeted therapy~     ...).~   "
60291|NCT02777684|"~     This study sought to better identify the motivators and barriers to osteoarthritic patients~     practising regular physical activity. This is a crucial step towards enabling each health~     professional to adapt their therapy recommendations, while taking into account the patient's~     overall lifestyle.~   "
60292|NCT02777671|"~     Single centre, randomised, open-label, two-way crossover study to investigate whether~     multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) affects the~     pharmacokinetics of gliclazide.~   "
60293|NCT02777658|"~     The objectives of this study are to assess molecular testing, treatment patterns, and~     associated outcomes among patients with EGFR (Epidermal Growth Factor Receptor)~     mutation-positive locally advanced or advanced NSCLC (Non-Small Cell Lung Cancer) who have~     progressed on or after EGFR-TKI (EGFR-Tyrosine Kinase Inhibitor) therapy post availability of~     a third-generation TKI (primary study cohort). Additionally, molecular testing and treatment~     patterns will be assessed among a secondary cohort of patients which will include patients~     diagnosed with de-novo EGFR T790M mutation-positive locally advanced or advanced NSCLC.~   "
60332|NCT02777151|"~     This is a Phase 1, randomized, double-blind, placebo-controlled, dose escalation study~     evaluating the safety, tolerability, pharmacokinetics (PK) and immunogenicity of~     REGN3470-3471-3479 in healthy adult volunteers.~   "
60299|NCT02777580|"~     In elderly patients ≥ 70yrs with acute ST-elevation myocardial infarction randomised within 3~     hours of onset of symptoms the efficacy and safety of a strategy of early fibrinolytic~     treatment with half-dose tenecteplase and additional antiplatelet therapy with a loading dose~     of 300 mg clopidogrel, aspirin and coupled with antithrombin therapy followed by~     catheterisation within 6-24 hours or rescue coronary intervention as required, will be~     compared to a strategy of primary PCI with a P2Y12 antagonist and antithrombin treatment~     according to local standards.~   "
60300|NCT02777567|"~     The objectives of this study are to assess the safety and efficacy of single agent Tagrisso~     (Osimertinib, hereinafter the study drug) in a real world setting in adult patients with~     advanced or metastatic, epidermal growth factor receptor (EGFR) T790M mutation-positive~     Non-Small Cell Lung Cancer (NSCLC), Who Have Progressed on or after EGFR tyrosine kinase~     receptor (TKI) therapy.~   "
60301|NCT02777554|"~     This study will be conducted in 2 Parts. The purpose of this study is to measure how much of~     apremilast is found in the blood when administered as a once daily tablet compared to a twice~     a day tablet, when given as multiple doses (Part 1) and when administered as a single dose~     under fasting and fed conditions (Part 2). Information on the safety and tolerability of~     apremilast will also be obtained. In addition, the effect of apremilast on certain biomarkers~     in the blood will be evaluated in 16 assigned subjects (Part 1 only). Biomarkers are~     substances such as proteins that tell us how the study drug is working in your body.~      Part 1: This is a multi-center, phase 1, open-label, randomized, two-period, two-sequence,~     crossover study in healthy subjects. The study will consist of a screening phase, a baseline~     phase, two treatment periods, and a follow-up phone call. Each Period will be ten days in~     duration (Day 1 through Day 10) for dosing and sample collection for up to 72 hours post Day~     7 morning dose of Periods 1 and 2. There will be a washout between Period 1 and Period 2.~     Part 2: This is a single center, open-label, randomized, four-period, four-sequence crossover~     study to evaluate the PK and exposure of apremilast following single dose administration of~     different formulations of apremilast. Part 2 will consist of a Screening phase, Baseline,~     four Treatment periods, and a follow-up phone call. Each Period will be four days in duration~     (Day 1 through Day 4) for dosing and sample collection for up to 72 hours post Day 1 of~     Period 1, 2, 3, and 4.~   "
60302|NCT02777541|"~     There aren't sufficient randomized prospective controlled trials in pediatric population~     comparing the safety and tolerance of early feeding after PEG placement (3-4 hours). Most~     patients are fasted for at least 12 hours following percutaneous endoscopic gastrostomy. In~     order to decrease the period of fasting, inadequate nutritional support, and hospitalization~     time, the investigators decided to design this study. The additional goal is to establish an~     optimum standard procedure in the group of pediatric patients qualified for PEG insertion~     procedure in Poland.~   "
60303|NCT02777528|"~     The objective of this study is to determine whether the GORE® TAG® Thoracic Branch~     Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending~     thoracic aorta.~   "
60304|NCT02777515|"~     Justification Smoking is a major factor for mortality and cardiovascular morbidity. The~     electronic cigarette, sometimes presented as smoking cessation classic is expanding but its~     safety has not been established to date. The smoke from the electronic cigarette is mainly~     composed of propylene glycol, some adverse effects were observed in animals.~      Study Type interventional study assessing the effect of the electronic cigarette Inclusion~     criteria Topics under 35 years presenting to Rhythm of the consultation for a cardiovascular~     evaluation and already smoking the electronic cigarette and that for at least 1 month~      Exclusion criteria~        -  Consumption of traditional cigarettes, nicotine replacement or toxic~        -  Presence of heart disease Primary objective To evaluate in a pilot study the immediate~          cardiovascular effects of electronic cigarette consumption Number of patients 20~          Duration of Study Recruitment in 2015 for an unlimited period of inclusion. Exam time is~          about two hours.~      Procedures performed during the study Physical examination, ECG, Holter-ECG 10 minutes and~     echocardiography were performed before and 15 minutes after the consumption of the usual~     electronic cigarette of the subject.~      No additional follow-up visit is required~   "
60305|NCT02777502|"~     The purpose of the proposed study is to investigate the effectiveness of cannabidiol for~     reducing marijuana seeking in non-treatment seeking volunteers. Cannabidiol is a cannabinoid~     (similar to cannabis, or marijuana) present in marijuana that alters some of the effects of~     marijuana.~      Assess the ability of acute smoked CBD pretreatment to reduce marijuana-seeking behavior and~     increase price-elasticity of marijuana demand.~   "
60306|NCT02777489|"~     The primary objective of this study is to evaluate the Carboxipeptidase D (CPD) genotyping as~     a predictive biomarker of body weight and/or fat mass reduction in obese patients treated~     with perindopril.~      There is nonclinical and clinical evidence that a subgroup of human subjects may present a~     decrease in body weight and/or fat mass following treatment with perindopril. Although the~     individual characteristics that determine such effect are still unknown, Gene PreDiT SA~     (Biocant Park, Cantanhede, Portugal) discovered that certain genetic characteristics (e.g.,~     single nucleotide polymorphisms (SNPs) of CPD gene) may play a role and potentially could~     serve as a potential predictive biomarker of response to perindopril.~      These promising results, along with the fact that perindopril is a medicine already in use in~     clinical practice, led Gene PreDiT SA to decide to proceed with the development of a~     theranostic approach for the treatment of obesity. Such theranostic approach consists on the~     use of CPD genotyping to identify obese subjects that could present improved body weight and~     fat mass reduction following treatment with perindopril.~      The current clinical trial aims to prove the concept and provide data to design further~     confirmatory studies. Additionally this study will evaluate the association between CPD SNPs~     genotypes and response to perindopril; the effect of perindopril in waist circumference,~     waist/hip ratio, and BMI and the tolerability and safety of perindopril in the study~     population.~   "
60307|NCT02777476|"~     This is a post-marketing study for B-Lite® implants that carry the EC certificate for~     marketing in Europe and AMAR certificate for marketing in Israel. To date, hundreds of~     implants have already been implanted in women. The study is open for primary augmentation~     patients only. All surgeries will be performed as per standard practice at the given study~     site. No parallel surgical procedures will be performed at the same session.~   "
72892|NCT02612857|"~     The purpose of this study is to determine how safe and effective IMO-8400 is in adults with~     dermatomyositis.~   "
60309|NCT02777450|"~     This study evaluates the predictor value of manual test in lumbar chronic patients blocks.~     Bibliography has show limited evidence of clinical predictors in lumbar blocks. Prior to~     lumbar facet block or medial branch denervation patient will be evaluated with manual~     provocative segmental movements, lumbar sagittal range of motion, manual segmental movement~     and slump neural test . Immediate, one and six months effect will be registered.~   "
60310|NCT02777437|"~     Primary Outcome Measures: Disease free survival~      Secondary Outcome Measures:~      Overall survival~      Adverse events (Mortality, morbidity)~      The proportion of completion of Laparoscopic Surgery~      Estimated Enrollment: Oct, 2016~      Study Start Date: Oct, 2016~      Estimated Study Completion Date: Oct, 2019~      Estimated Primary Completion Date: Oct, 2021~      Groups/Cohorts~        1. Laparoscopic surgery for T4 colon cancers~        2. Neoadjuvantive chemotherapy + Laparoscopic surgery for T4 colon cancers~   "
60311|NCT02777424|"~     This prospective, randomized, multicenter study is performed to determine whether prothrombin~     complex concentrates confers any benefits over fresh frozen plasma in adult neurological~     patients with coagulation disorders (PT value less than 60%).~   "
60312|NCT02777411|"~     The objectives of this study are to evaluate the immune response and safety profiles of two~     injections of EV71 vaccine administrated with or without adjuvant AlPO4 at 0.5-μg, 1-μg, 2-μg~     and 5-μg dose (if required) in children aged 3 to 6 years old and 0.25-μg (if required),~     0.5-μg, 1-μg and 2-μg (if required) in 6 to 35 months old infants/toddlers.~   "
60313|NCT02777398|"~     Intra-spinal canal tumors are the general term of primary tumors from spinal cord or various~     tissues in the spinal canal and adjacent to the spinal cord, while the metastatic tumors are~     those from other sites other than spinal canal. Intra-spinal canal tumor is one of the most~     common diseases in neurosurgery, and surgery is the most effective treatment. Conventional~     open surgery is required to remove the posterior structures of the spine, which would lead to~     fracture of the posterior tension band, soft tissue injury, spine instability, and even spine~     deformity. So it is very important to protect and rebuild the posterior tension band for the~     stability of the spine. The team of Dr. John P. Kostuik from the Department of Orthopedics~     and Neurosurgery, the Johns Hopkins University, firstly introduced minimally invasive surgery~     for cervical and lumbar degenerative disease. However it has not been applied to the~     treatment of intra-spinal canal tumors. To date, the microsurgery of intra-spinal tumor~     through the trans-Quadrant channel pathway has not been widely performed in clinical~     practice. The investigators performed the microsurgery of intra-spinal canal tumor through~     the trans-Quadrant pathway in some patients previously and succeeded in the surgical~     treatments. The investigators analyzed the clinical data retrospectively, including surgical~     incision length, the volume of bleeding during operation, post-operative drainage volume,~     post-operative out-of-bed time point, post-operative length of stay in hospital, and~     post-operative visual analog pain (VAP) score. The group of patients using microsurgical~     technique through trans-Quadrant channel pathway showed better outcome compared with the~     group of patients using conventional open surgery. This innovation of microsurgery showed~     fewer traumas and bleeding, more rapid recovery, better prognosis and more safety in~     practice. Since there are some limitations to the retrospective study, it is necessary to~     design a prospective randomized controlled trial of the treatment of intra-spinal canal~     tumors using microsurgical technique through trans-Quadrant channel pathway.~   "
60314|NCT02777385|"~     The study regimen consists of cisplatin and radiation for all patients, the standard~     treatment for head and neck cancer. All patients will also receive pembrolizumab (the study~     drug), and will be randomized to two treatment schedules: either pembrolizumab with~     cisplatin-radiation, or pembrolizumab after completing cisplatin-radiation.~      The goal of this research study is to learn which therapy order (adding pembrolizumab during~     vs. after cisplatin and radiation) may be more effective in treating head and neck cancer, as~     well as learn the side effects of these combinations.Pembrolizumab is an immune therapy, a~     drug that stimulates the immune system to fight cancer, and is FDA approved in lung cancer~     and melanoma. It is not currently FDA approved for head and neck cancer.~   "
60315|NCT02777372|"~     This is a pilot study that aims to evaluate the psychophysiology of premenstrual mood~     disorders (PMDs) at baseline and after treatment with sertraline. Participants will include~     women with PMDs and healthy male and female controls. Participation involves a baseline visit~     to determine eligibility and three study visits that include questionnaires and stress~     reactivity assessment via an acoustic startle paradigm, cortisol, and immune markers, as well~     as hormone and genetic measures. Female participants with PMDs will receive sertraline during~     the premenstrual phase.~   "
60316|NCT02777359|"~     The foramen ovale, a kind of physiologic channel in the interatrial septum in the heart at~     embryonic stage, is closed normally at 5-7 months after birth. When it is not closed, it is~     referred to as the patent foramen ovale (PFO), which is found in approximately 1/4 of general~     population. It was shown in the studies in recent years that the risks of cryptogenic stroke,~     migraine, peripheral arterial embolism and decompression sickness in the patients with PFO~     were several times higher than those in healthy people. Therefore, PFO, previously considered~     a condition without the necessity of treatment, causes the attention of many experts and~     scholars around the world. Migraine with or without aura is defined as one of the most~     disabling chronic diseases, since according to WHO, the disability adjusted life year caused~     by migraine was second only to that by non-fatal stroke in 2005. In recent years, an~     increasing number of researches suggested that migraine is closely related to the~     right-to-left shunt (RLS) in the heart. And PFO is clinically considered as the most common~     cause of RLS.~      The closure treatment for PFO-induced migraine has been gradually applied in several~     hospitals in China. The relationship of PFO with migraine, however, was not evaluated~     systematically based on specific standards, unfortunately leading to non-inclusion of many~     high-risk patients with PFO in the evaluation. The following aspects are to be fully~     recognized: the selecting and screening procedures for the high-risk population with~     PFO-induced migraine; the indications and standards of closure treatment for PFO in the~     patients with PFO-induced migraine; and the possibility that the made-in-China occluders~     substitute for those imported in the prevention from migraine. Furthermore, there is still a~     lack of prospective, multi-center, randomized and controlled studies in this subject, and~     standard or normal screening and treatment procedures have not yet been established in China.~     From this point, the investigators developed the Chinese people-specific procedures and~     standards of diagnosis of PFO-induced migraine in this study, based on current standards and~     methods of diagnosis, treatment and prevention of PFO-induced migraine in foreign countries.~     And the investigators prospectively adopted continuous inclusion of the high-risk patients~     with PFO-induced migraine, who were randomly divided into the closure treatment~     (transcatheter closure of PFO) group and the medication (drugs administered alone) group at~     the ratio of 1:1., in order to evaluate if the interventional treatment is better than the~     medication alone in these patients, to assess the efficacy and safety of the made-in-China~     occluders in the interventional treatment and prevention of PFO-induced migraine, and to~     identify the incidence of PFO in the patients with migraine in China and develop the Chinese~     people-specific screening protocols of PFO-induced migraine.~   "
60317|NCT02777346|"~     The investigators recruit patients admitted to the Pediatric Emergency Department of the~     Geneva's University Hospital with open wounds needing suture. The patients are treated with~     absorbable versus non-absorbable suture material according to randomization.~      Outcomes are:~        1. infection rate at the first follow-up (between 4 and 14 days, depending on the sutured~          site and defined by protocol)~        2. scar appearance at a 6-months follow-up.~   "
60318|NCT02777333|"~     The purpose of this study is to determine whether simulation training improves the~     performance during arthroscopic surgery ('keyhole' surgery into a joint).~   "
60319|NCT02777320|"~     Currently, Paracetamol and Ibuprofen are widely used by emergency physicians in Turkey for~     the pain treatments.~      The objective of the study was to assess whether intravenous Paracetamol has superior~     Sciatica pain reduction will compare with Ibuprofen in emergency department (ED) adults.~      Half of the participants will receive Paracetamol and the other half will receive Ibuprofen.~   "
60321|NCT02777294|"~     Rape is unfortunately a common experience among women, affecting between 13 and 20%. In~     addition, up to 50% of all rape victims experience significant and persistent psychological~     distress. While cognitive-behavioral interventions have been found to be successful at~     alleviating distress among victims; the majority do not seek out these services, often~     because of feelings of stigma and self-blame. One potential method for circumventing these~     barriers is through online administered treatment. Thus, the current project is designed to~     conduct an initial evaluation of a 12 to 16-week, therapist-facilitated, multi-media,~     cognitive-behavioral, online intervention tailored specifically for rape victims. The~     effectiveness of this program at ameliorating distress among college women who have~     experienced rape and have current posttraumatic stress disorder (PTSD) was evaluated.~     Reductions in psychological distress was the primary outcome and was assessed at~     post-intervention and at three and six month follow-up periods. The effectiveness of the~     intervention was compared to a psycho-educational website.~   "
60322|NCT02777281|"~     This study will compare two exercise programs in an interventional study for manual~     wheelchair users with spinal cord injury and shoulder pain. Subjects without spinal cord~     injury will also be enrolled to compare exercise approaches.~   "
60323|NCT02777268|"~     This was a single centre, open-label, randomised, 5-way crossover study.~   "
60324|NCT02777255|"~     Hypothesis: CAV is associated with fibrotic changes on cardiac MRI, altered levels of~     pathogenetically-related biomarkers, and specific RNA expression changes in the blood~   "
60325|NCT02777242|"~     Evaluation of the safety and tolerability of testosterone enanthate (TE) following a single~     dose via QuickShot® Testosterone (QST) when administered by intended users in a usability~     study.~   "
60326|NCT02777229|"~     Several reports indicate that treatment failure due to HIV resistance or to adverse~     event-related discontinuation could compromise the effectiveness of scaling-up antiretroviral~     treatment (ART), especially when lack of access to viral load is a concern. Combined with~     other nucleoside reverse transcriptase inhibitor, Dolutegravir (DTG) is a very promising~     alternative to the current first-line non nucleoside reverse transcriptase inhibitor-based~     regimens.~      Initial evaluations of DTG conducted in high income countries showed excellent efficacy and~     safety and indicated high genetic barrier thus preserving second line treatment. As a~     consequence, DTG-based regimens have been recently included in the first-line options in the~     national guidelines for ART of several high-income countries. However, the clinical trials~     evaluating DTG-based regimens have been conducted in highly controlled conditions, including~     baseline resistance testing and regular viral load monitoring. Moreover, these trials~     included a high proportion of men with rare co-morbidities.~      There is need to evaluate how a DTG-based regimen will perform in real-world conditions~     within resources-constrained settings, where viral load monitoring is limited, and where the~     majority of HIV patients are women with important family planning consideration and NAMSAL~     trial is a randomized clinical trial which aims to evaluate efficacy and safety over 48 weeks~     of DTG + tenofovir disoproxil fumarate/lamivudine versus Efavirenz (EFV) + tenofovir~     disoproxil fumarate/lamivudine in 606 ART-naïve HIV-1-infected adults in Cameroon. A set of~     efficacy and safety endpoints will be compared over 48 weeks between the two arms including~     the proportion of patients with viral load <50 copies/mL and incidence of severe adverse~     events.~   "
60327|NCT02777216|"~     To evaluate the safety and performance of the ConfidenHT System~   "
60328|NCT02777203|"~     The purpose of this study is to determine the safety and efficacy of insufflated bags for~     electromechanical power morcellation during laparoscopic hysterectomy and myomectomy for~     tissue removal and to observe the integrity of the bags throughout and after insufflation and~     power morcellation.~      The hypothesis is the bags will remain in tact without leakage from the bags during and after~     power morcellation using the described contained system, confirming the safety and efficacy~     of the systems.~   "
60329|NCT02777190|"~     The purpose of this study is to study if misoprostol administered orally is at least as~     effective as misoprostol administered vaginally for cervical ripening and the induction of~     labor. The main purpose is to show that oral misoprostol administration is non-inferior to~     vaginal misoprostol administration with respect to the time interval from misoprostol~     administration to onset of active phase of labor. The study is a non-inferiority, prospective~     randomized controlled trial comparing oral misoprostol given as 25 mcg every 2 hours versus~     vaginal misoprostol given as 25 mcg every 4 hours.~   "
60330|NCT02777177|"~     Bariatric surgery is a powerful tool for producing significant and durable weight loss. Yet,~     not all patients achieve initial weight loss success and many patients have weight regain as~     early as 1-2 years post-surgery. Suboptimal weight loss patterns not fully explained by~     surgical, demographic, and medical factors has led to greater emphasis on patient behaviors~     evidenced by clinical guidelines that focus on appropriate eating and physical activity.~     However, research to inform such guidelines typically has relied on imprecise measures or not~     been specific to bariatric surgery. There is also little understanding of mechanisms by which~     psychosocial factors influence outcomes. Thus, there is a need to: (a) measure behaviors and~     psychosocial factors thought to be related to surgical outcomes (particularly those~     emphasized in guidelines) using innovative strategies to maximize data quality, (b) determine~     which behaviors and psychosocial factors are related to outcomes, and (c) explore how~     psychosocial factors influence weight both directly and via influences on behavior. Our~     research team was the first to employ innovative mobile health (mHealth) technology within an~     Ecological Momentary Assessment (EMA) framework to measure adherence to recommended behaviors~     at 6 months post-surgery. The investigators propose to build on this work by using EMA to~     measure behavioral, psychosocial, and environmental factors over a longer period to~     understand how they predict success and risk after surgery. An NIH-funded multi-sensor PiLR~     HEALTH platform will integrate objective sensor data measuring behaviors and the environments~     in which they are performed with self-report information collected via smartphone in~     real-time and in patients' natural environment. Participants (N=100) recruited from 2~     ASMBS-designated centers of excellence will complete a 10-day EMA protocol pre-surgery and at~     3, 6, and 12 months post-surgery to assess recommended behaviors [e.g., meal frequency, PA],~     psychosocial indicators with the most prior evidence of an association with surgical outcomes~     (e.g., mood/depression), and key environmental factors (e.g., type/quality of the food~     environment). Participants will also be weighed at the above time points. Along with~     describing patterns in behaviors and their relation to weight loss, the investigators will~     test causal models to understand how complex systems of behavioral, psychosocial, and~     environmental factors affect weight loss, and to identify optimal targets for intervention.~     This project has the potential to build a much more sophisticated and valid understanding of~     who is and is not successful after bariatric surgery and why. This new understanding will~     directly contribute to improved (i.e., specific, consistent, and validated) guidelines for~     recommended pre and postoperative behaviors, which could lead to improved surgical outcomes.~     The enhanced understanding will also inform behavioral, psychosocial, and environmental~     targets for intervention that are mostly likely to improve surgical outcomes.~   "
60331|NCT02777164|"~     The objective of the study is to estimate the diagnostic accuracy of cancer detection when~     MIRA technology is combined with mammography, by evaluating the area under the ROC curve~     (AUC) of mammography vs. mammography plus MIRA. This evaluation will be done in a Reader~     Study on a subset of women with histology confirmed cancer and healthy women with dense~     breast.~   "
60334|NCT02777125|"~     This study is determines if metered dose inhalers are as effective as breath actuated~     nebulizers for the treatment of mild to moderate asthma exacerbations in pediatric patients~     presenting to the emergency department. Half of the participating patients received albuterol~     via the metered dose inhaler whereas the other half received albuterol via the breath~     actuated nebulizer.~   "
60335|NCT02777112|"~     There is a pressing need for innovation in prevention of major depression in male workers.~     Major depression (MDE) affects workers' health and productivity. In the United States,~     workers with depression cost an estimated US $44.01 billion per year in lost productivity.~     One of the severe consequences of having MDE is potential suicide and Canadian national data~     showed that 76% of all suicides in 2009 were male. In the workplace, risk factors for having~     MDE differ for men and women. For instance, job strain, family to work conflict and job~     insecurity seem to be more prominent MDE risk factors in men than in women. Compounding men's~     risk, men are less likely than women to seek help and to disclose depressive symptoms and~     often delay help seeking until symptoms become severe. Men are socialized to be emotionally~     stoic and exemplify traditional masculine characteristics such as independence, self-reliance~     and dominance. Men are concerned over the perceived negative judgments from family and~     friends if they access treatment for depression. These gender specific experiences along with~     a limited knowledge base about effective interventions call for innovative solutions tailored~     for men. The proposed study was to evaluate the effectiveness of an e-mental health program~     on reducing the risk of major depression in Canadian working men.~   "
60336|NCT02777099|"~     The purpose of this study is to determine whether remote ischemic postconditioning (RIPostC)~     initiates autonomic nervous system response and affects the prognosis in patients with acute~     ischemic stroke.~   "
60337|NCT02777086|"~     The purpose of the Texas Christian University (TCU) Disease Risk Reduction (DRR2) Project is~     to develop and test a self-administered tablet computer app, StaySafe, for probationers under~     community supervision that is designed to improve decision-making skills around health risk~     behaviors, especially involving HIV and hepatitis B & C risks. StaySafe utilizes materials~     and concepts adapted from an earlier, group-based curriculum, WaySafe, designed to increase~     positive decision-making skills for offenders in the last phase of their prison-based~     substance abuse treatment before transitioning back to the community.~   "
60338|NCT02777073|"~     1. To compare levels of ketone bodies (beta-hydroxybutyrate and acetoacetate) in plasma and~          urine following a single dose treatment of either liraglutide 1.8mg,dapagliflozin 10mg~          or placebo in insulinopenic state.~        2. To compare plasma levels of free fatty acid, glucagon, hs-CRP, Il-6 and IL-1 before and~          after administration of liraglutide/Dapagliflozin/placebo.~   "
60339|NCT02777060|"~     Explore the benefit of the game-based virtual reality system in improving lower extremity~     kinematics and balance in patients suffering from disease/disorders including Diabetes,~     Cancer, Multiple Sclerosis, Arthritis, Parkinson's disease, Cognitive Disorders, Brain~     Injury, Stroke or Frailty. A four to six weeks of training with 2 training session/week will~     be provided.~   "
60340|NCT02777047|"~     Oral anticoagulants (warfarin, dabigatran, rivaroxaban and apixaban) are the very top cause~     of serious drug-related harm. More than 7 million prescriptions are dispensed annually for~     oral anticoagulants (OAC) in Canada, with more than 340,000 recipients in Ontario Drug~     Benefit Program alone. Because of their very high and chronic utilization, their large~     benefit in lowering important clinical events (stroke, embolism, death) and their high~     potential for major harm (primarily bleeds, which can be fatal), OACs are the highest~     priority for improving medication safe and effective use. The early period after hospital~     discharge is clearly high risk, with three times the usual rate of major bleeds compared with~     later. Since healthcare has been declared unsustainable in its current delivery form, it is~     time that Hamilton hospitals took the lead in finding more cost-effective ways to improve~     anticoagulation safety. The investigators will do this by structuring discharge medication~     assessment, with formal handover to telehealth coordination and communication with patients~     and their providers, to extend access and reduce the cost of expert anticoagulation guidance.~     This innovative study will rigorously and efficiently address whether a focused care~     coordination intervention targeting the highest priority medication safety topic~     (anticoagulants), delivered by telehealth experts already providing other services for~     Ministries of Health, can improve outcomes and reduce costs of care. The rigorous research~     design tests whether high quality, easily scalable, teletriage coordination can be effective~     in preventing anticoagulation-related adverse events during the most risky time period of~     therapy - transition from hospital to home.~   "
60341|NCT02777034|"~     Laparoscopy combined with an enhanced recovery pathway versus laparoscopy combined with a~     traditional recovery pathway after ileocolon resection for Crohn's Disease.~   "
60342|NCT02777021|"~     Treatment for pediatric acute myeloid leukemia (AML) involves intensive chemotherapy regimens~     that result in periods of profound neutropenia leaving patients susceptible to severe~     infectious complications. Infectious complications are the leading cause of treatment related~     mortality among AML patients, but there are little clinical data to inform whether management~     of neutropenia post AML chemotherapy should occur in an outpatient or inpatient setting.~     Further, no studies have been conducted that assess the impact of neutropenia management~     strategy on the quality of life of pediatric patients with AML and their caregivers.~   "
60343|NCT02777008|"~     Single- and multiple-ascending dose study of CTP-543 in healthy volunteers.~   "
60344|NCT02776995|"~     This research aims to investigate the correlation between tumor temperature difference and~     biological factors, such as size, metabolism, treatment response, and tumor aggressiveness.~      In addition, normal tissue response to adjuvant radiation therapy in treated organs following~     surgery, will be evaluated.~   "
60345|NCT02776982|"~     This study is being done to help understand why some people with an increased amount of~     central obesity, without gastroesophageal reflux, develop changes to the lining of their~     esophagus that can potentially lead to esophageal adenocarcinoma (cancer).~   "
60346|NCT02776969|"~     The aim of this project is to identify genetic risk factors associated with familial~     papillary thyroid carcinoma (PTC). Papillary thyroid cancer is a type of cancer that shows~     high heritability. However, the specific genetic factors that cause an increased risk have~     been elusive.~   "
60347|NCT02776956|"~     A total of 120 patients with persistent atrial fibrillation (including continuous and~     long-standing persistent atrial fibrillation) and 60 patients with paroxysmal atrial~     fibrillation will receive radiofrequency ablation. Patients in each group will be randomly~     allocated into the statin treatment group and non-statin treatment group (allocation ratio,~     1:1). Left atrial appendage flow velocity of all patients are measured by Transesophageal~     Echocardiography(TEE) 24 hours before the operation. Real-time ultrasound examinations of~     left atrial function are carried out for all patients before the operation and after the~     operation. Blood samples are extracted in all patients before the operation and after the~     operation. This study will clarify whether the application of statin drugs can improve~     postoperative left atrial function. This study will identify the time course and influence~     factors of left atrial recovery of atrial fibrillation after the operation to guide the time~     and the degree of anticoagulation and effectively prevent thromboembolic events. At the same~     time, biochemical indicators are detected to analyze which indicators are related to the~     postoperative recurrence of atrial fibrillation, the incidence of postoperative thrombosis~     and the recovery of postoperative left atrial function. Furthermore, this study will~     investigate whether the application of statin drugs can improve postoperative left atrial~     function by affecting these indicators.~   "
60348|NCT02776943|"~     The purpose of this study is to investigate the efficacy and safety of transplantation of~     umbilical cord mesenchymal stem cells（UCMSCs） in patient with Knee cartilage damage.~   "
60349|NCT02776930|"~     The purpose of this study is to develop algorithms that will help predict future injury~     and/or re-injury after being returned to duty from a musculoskeletal injury. After completion~     of an episode of care with a physical therapist, the subjects will undergo a battery of~     physical performance tests and fill out associated surveys. The subjects will then be~     followed for a year to identify the occurrence/re-occurence of any injuries. Based on the~     performance on the physical evaluation tests, algorithms will be derived using regression~     analysis to predict injury.~      Subjects will be recruited from the pool of patients that have recently completed physical~     rehabilitation in physical therapy clinics for their lower extremity or lumbar/thoracic spine~     injury.~   "
60350|NCT02776917|"~     This is a pilot phase 1b study to investigate the safety and side effects of combining the~     ROR1-targeting monoclonal antibody, cirmtuzumab, with paclitaxel for patients with HER2~     negative, metastatic breast cancer. Cirmtuzumab is a type of drug called a monoclonal~     antibody. This drug is designed to attach to a protein called receptor-tyrosine-kinase like~     orphan receptor 1 (ROR1) on the surface of breast cancer cells. Cirmtuzumab blocks the growth~     and survival of the breast cancer cells in laboratory tests. ROR1 is rarely expressed on~     healthy cells. Cirmtuzumab is considered experimental and is not approved by United States~     (U.S.) Food and Drug Administration (FDA).~   "
60351|NCT02776904|"~     Previous work in the area of concussion management has focused heavily on neuro-cognitive~     testing. In addition to routine neuro-cognitive testing through Immediate Post-Concussion~     Assessment and Cognitive Testing (ImPACT),this pilot study is designed to establish a~     comprehensive battery of clinical assessment through the utilization of functional movement~     and dynamic postural control assessments. The immediate application of these assessments will~     be focused on the male high school football player (who is at risk for concussion) and both~     female and male soccer players. Our pilot study aims determine the stability of ImPACT~     testing in youth athletes in light of ongoing neurodevelopment in this population. In~     addition, this pilot work will implement additional tools focused on assessment of dynamic~     balance, reaction time, and agility. This approach will significantly enhance predictions of~     subsequent musculoskeletal injuries that have been shown to occur in concussed collegiate and~     professional athletes and that we believe are also occurring in our high school athletes.~     This battery of tests will provide clinicians with invaluable information to guide both~     rehabilitation of and return to play (RTP) decisions for concussed high school athletes. This~     pilot study will further track those athletes who sustain a concussion and assess increased~     risks for musculoskeletal injury.~   "
60352|NCT02776891|"~     This is a single center imaging study investigating the use of PET with 68Ga-citrate in~     patients with DLBCL or BCLU.~   "
60353|NCT02776878|"~     The purpose of this study is to determine whether dasatinib is effective and safe in the~     treatment of refractory metastatic gastrointestinal stromal tumor~   "
60354|NCT02776865|"~     This study was conducted to compare the efficacy of hydrodilatation with hyaluronic acid~     under ultrasonographic guidance plus physical therapy (PT) with that of PT alone for treating~     adhesive capsulitis~   "
60355|NCT02776852|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
60356|NCT02776839|"~     The objective of this study is two fold, first to explore the potential of context sensitive~     intervention delivery to provide in-situ support for people with depressive symptoms, second~     to explore the detection of daily-life behavior based on smart phone sensor information to~     identify subjects with a clinically meaningful depression level.~   "
60357|NCT02776826|"~     The World Federation of Hemophilia (WFH) is conducting the pilot phase of an international,~     observational, World Bleeding Disorders Registry (WBDR). This pilot phase will assess the~     feasibility of conducting an expanded WBDR to more centres with a more comprehensive case~     report form, around the world.~   "
60358|NCT02776813|"~     This is a phase 1, multi-center, single-arm, open-label study evaluating the safety and~     efficacy of an autologous T-cell product expressing ACTR in combination with rituximab in~     subjects with refractory or relapsed CD20+ B-cell lymphoma.~   "
60371|NCT02776644|"~     The clinical outcome of advanced / metastatic renal cell carcinoma has been changed since~     targeted therapy being widely applied. This study will retrospectively analyse the clinical~     outcome of advanced renal cell carcinoma captured in Taiwan National Health Insurance~     Research Database.~   "
60372|NCT02776631|"~     A prospective randomized study comparing a new implant with three interlocked pins for~     internal fixation of femoral neck fractures (Hansson Pinloc System, Swemac Linköping, Sweden)~     versus 2 parallel pins with hooks (Hansson Pins, Swemac Linköping, Sweden).~   "
60386|NCT02776449|"~     The main aim of this study is to determine the trans-laminal cribrosa pressure difference~     (TLCPD) for normal tension glaucoma (NTG) patients from the brain and the eye in supine,~     upright and minor head down tilt positions. It is also to investigate the venous drainage~     system in the same body positions.~   "
60359|NCT02776800|"~     When elderly patients need help caring for wounds, physicians may refer patients to home~     health care providers. The home health provider sees the patient in the patient's home and~     assists the patient with wound care. Working with the patient's physician, the home health~     provider will use the appropriate wound covering (dressing or bandage) to cover the~     wound. The goal of the home health provider is to ensure that the wound stays clean and~     progresses toward closure. The home health provider will conduct in-home patient visits at~     appropriate intervals to assess the status of the wound.~      Extensive resources are required to see patients in their own homes. If a dressing could~     effectively manage wounds and allow longer time between in-home visits (without affecting~     patient safety or progress of the wound toward closure), then resources could be saved. Thus,~     newer dressings are designed for longer wear times, using advanced foam pads and adhesives~     that help keep the dressing in place. The hypothesis of this study is that the use of Allevyn~     Life will decrease the number of in-home visits by home health providers without sacrificing~     patient safety.~   "
60360|NCT02776787|"~     Half of all Americans over 60 years of age have diverticulitis of the colon. Over the last~     decade, the use of elective colon resection has increased by more than 50%, and~     diverticulitis is now the leading reason for elective colectomy. Surgeons and patients alike~     have a difficult time deciding if surgery is the best choice to treat diverticulitis. The~     goal of the DEBUT study is to improve the understanding about how doctors and patients make~     decisions to have elective surgery for diverticulitis, and the global impact of~     diverticulitis on patients' lives.~   "
60361|NCT02776774|"~     There is considerable interest in using in-wound antibiotics (IWA) to prevent infection after~     spine surgery. An adequate evaluation of IWA is lacking and prior studies are limited by~     confounding and bias. This prospective study will enroll spine surgeons across the country to~     complete a survey about their knowledge, attitudes, and practices for using in-wound~     antibiotics.~   "
60362|NCT02776761|"~     This is a single-center, randomized, single-blinded study of the HTNV DNA vaccine alone, PUUV~     DNA vaccine alone, and mixed HTNV/PUUV DNA vaccines delivered IM by the needle-free PharmaJet~     Stratis DSJI device.~   "
60363|NCT02776748|"~     The purpose of this study is to quantify the magnitude and extent of infant exposure to daily~     emtricitabine (FTC) /tenofovir disoproxil fumarate (TDF) via maternal breastmilk when taken~     pre-exposure prophylaxis (PrEP) by lactating HIV-uninfected women. The primary outcome is the~     steady state concentrations of emtricitabine and tenofovir in the infant plasma.~   "
60364|NCT02776735|"~     Primary Objective:~      To describe the pharmacokinetic (PK) profile of sarilumab in patients with pcJIA in order to~     identify the dose and regimen for continued development in this population.~      Secondary Objective:~      To describe:~        -  The pharmacodynamic (PD) profile, the efficacy and the safety of sarilumab in patients~          with pcJIA.~        -  The long-term safety of sarilumab in patients with pcJIA.~   "
60365|NCT02776722|"~     Despite advances in the prevention and treatment of type 2 diabetes, its prevalence continues~     to rise worldwide. There is a need for new modalities to improve metabolic control in~     individuals with type 2 diabetes and those who are overweight or obese and at risk for type 2~     diabetes. Contrary to the concerns raised about the adverse role of fructose in metabolic~     health, various lines of evidence suggest that fructose and its epimers may improve the~     metabolic handling of glucose through inducing glycogen synthesis. Recent small trials in~     humans suggest that catalytic doses (=<10g/meal) of fructose and its epimers (allulose,~     tagatose, and sorbose) may reduce postprandial glycemic responses to carbohydrate loads~     (i.e., oral glucose tolerance test or a starch load) in people with and without type 2~     diabetes. There is also limited evidence that these acute effects may manifest as longer term~     improvements in glycemic control. There is an urgent need to synthesize the evidence of the~     effects of fructose and its epimers on postprandial carbohydrate metabolism.~   "
60366|NCT02776709|"~     Cholangioscopy, or direct visualization of the bile ducts was first documented in the late~     1970s and has made many advances over the last few decades. The advent of mother-baby scopes~     allowed for both diagnostic and therapeutic procedures, though the early scopes were often~     fragile, and cumbersome due to the need for two endoscopists. Ultraslim endoscopes later~     became popular as a method to digitally view the bile ducts, however, often needed guide-wire~     or balloon-assistance to allow for cannulation. Other disadvantages of these systems included~     limited steerability, and poor irrigation capabilities.~      The advent of Spyglass, a single-operator peroral cholangioscopy method allowed for a~     fiberoptic, catheter-based system that could be easily used for diagnostic and therapeutic~     purposes in the biliary system. However, image quality was often lacking due to the~     fiberoptic technology. The new digital Spyglass system rectifies this inadequacy by~     introducing a digital sensor for better image quality, which will allow for better~     visualization and diagnosis of indeterminate strictures. Furthermore, modification of the~     scope platform allows for efficient use, reliable directionality of the scope tip, and~     improved ease of passage of accessories during therapeutic procedures such clearing stones or~     stent placement.~   "
60367|NCT02776696|"~     The purpose of the study is to compare two closed-loop strategies in terms of glycemic~     control in Type 1 Diabetes during a camp setting.~      The proposed study is a three-segment feasibility study. One segment is a proof of concept~     study (with two parts) conducted as in-patient clinic study ,the second segment is two-arms,~     cross-over, randomized and single-center and the third segment is four-arms, parallel,~     randomized and single-center, in diabetes camp study in subjects with type 1 diabetes on~     insulin pump therapy.~      Segment 1 will be divided into two parts: part 1 is a single arm pilot study aim to asses~     logistical and safety issues in 12 patients and part 2 is a randomized cross over study aim~     to evaluate glucose performance using closed-loop control. Part 2-is a randomized cross-over~     (two arms) in-patient study: A total of 12 patients will participate in this part of the~     study. Following the run-in period subjects will be randomized to participate in two periods~     of closed-loop treatment, each period will last 36 hours in hospital setting. During the~     first period, glycemic control will be controlled by the Hybrid closed-loop system and during~     the second period by Hybrid Logic closed-loop system. The sequence of treatment first period~     HCL therapy than AHCL or vice versa will be randomly assigned.~      Segment 2 is a randomized cross-over (two arms) Camp Study including up to 30 patients.~     Following the run-in period subjects will be randomized to participate in two periods of~     closed-loop treatment, each period will last 2days in a camp setting, the total duration of~     the camp will be up to 6 days. In one period, glycemic control will be controlled by the~     Hybrid closed-loop system and another period by Hybrid Logic closed-loop system. The sequence~     of treatment first period HCL therapy than AHCL or vice versa will be randomly assigned.~      Segment 3 is a randomized, parallel (four arm) Camp Study including up to 80 patients.~     Following the run-in period subjects will be randomized to participate in one of 4~     intervention arms of closed-loop treatment in camp settings. The duration of the camp will be~     12 days in which glycemic control will be controlled by one of 4 versions of closed-loop~     system: Hybrid Closed Loop (HCL) or one of 3 versions of Advanced Hybrid Closed Loop (AHCL).~   "
60368|NCT02776683|"~     The objective of this trial is to evaluate the safety and tolerability of BI 695502 in~     combination with leucovorin/5-fluorouracil/oxaliplatin (mFOLFOX6) and as maintenance therapy~     (when applicable). As well as to evaluate the following efficacy parameters: Progression-free~     survival (PFS), objective response rate (proportion of patients with complete response [CR]~     plus partial response [PR]), overall survival (OS), duration of response (DOR), time to~     progression (TTP).~   "
60373|NCT02776618|"~     We will be recruiting patients requiring excisions of skin cancer and comparing aesthetic and~     functional differences of suture repair of excisional defects using polyglactin 910 vs~     poliglecaprone 25 with a split-scar model. Excision sites will be on either the trunk or~     extremities. Standard dermatological excision and repair methods will be used for removal of~     lesions and repair of the wound by surgeons; training courses will be used to limit~     inter-surgeon variation in technique. Excisional defects will be repaired with deep~     polyglactin 910 sutures, followed by randomly assigned subcuticular closure of one half of~     the defect with polyglactin 910 sutures and the other half with poliglecaprone 25 sutures.~     The patient will follow-up at 6 months and fill out a patient self-assessment evaluation~     survey of the scar. Photographs will also be taken of the scars at the follow-up at 6 months,~     which will be then be assigned to a set of blinded observers to evaluate the wound using a~     modified Patient Observer Self-Assessment Scale (mPOSAS). These observers will rate each scar~     on the mPOSAS scale and values will be averaged between observers. Total duration of~     participation will be 6 months, with 2 total visits (excision visit and follow-up visit).~   "
60374|NCT02776605|"~     Evaluate the response (complete hematologic response [CHR], complete cytogenetic response~     [CCyR], major molecular response [MMR] and complete molecular response [CMR] of the~     combination of ponatinib with standard chemotherapy (according to PETHEMA ALL Ph08 trial) in~     young patients with Ph+ (BCR-ABL) ALL.~      All patients are treated with:~      Pre-phase (maximum 7 days, -7 to -1):~      Prednisone 60 mg/m2/day IV over 7 days (-7 a -1) and triple intrathecal therapy (TIT)~     (Methotrexate [MTX]: 12 mg, ARA-C: 30 mg, hydrocortisone: 20 mg). 2. Induction (day 1 to day~     28 or up to hematological recovery) Vincristine (VCR): 1.5 mg/m2 (maximum 2 mg) IV days 1, 8,~     15 and 22. Daunorubicin (DNR): 45 mg/m2 IV days 1, 8, 15 and 22. Prednisone (PDN): 60~     mg/m2/day, IV or PO, days 1 to 27. Ponatinib 30 mg, PO from day 1 to consolidation. TIT, days~     1 and 22. 3. Consolidation (day 1 to day 63) Mercaptopurine (MP): 50 mg/m2, PO days 1 to 7,~     28 to 35 and 56 to 63. MTX: 1,5 g/m2, IV (24 h continuous infusion) days 1, 28 and 56. VP-16:~     100 mg/m2/12 h, IV, days 14 and 42. ARA-C: 1000 mg/m2/12 h, IV, days 14-15 and 42-43. TIT~     (MTX: 12 mg, ARA-C: 30 mg, hydrocortisone: 20 mg), , days 1, 28 and 56. Ponatinib 30 mg/d PO,~     from day 1 to 15 days before HSCT. 4. HSCT (performed ideally within 1 month from the end of~     consolidation). AlloHSCT preferred over autoHSCT (autoHSCT only indicated if alloHSCT not~     feasible). Myeloablative conditioning with cyclophosphamide and total body irradiation (TBI)~     whenever possible. 5. Post HSCT therapy After alloHSCT. Frequent monitoring of MRD (every~     month). I After autoHSCT: Frequent monitoring of MRD (every month).~   "
60375|NCT02776592|"~     This study aims to determine if a cow's milk-based formula with added nutrients has an effect~     on memory, reaction time, strategy or other cognitive development indicators in children 4-5~     years of age.~   "
60376|NCT02776579|"~     The majority of today's youth do not engage in enough physical activity (PA) to maintain good~     health. Low PA levels are associated with poor health (e.g. diabetes, high blood pressure)~     and early mortality. Girls are less likely than boys to be active, and their rates of~     participation drop off more steeply during adolescence. Girls report many barriers to~     exercise, including transportation issues and feeling self-conscious about their appearance~     and abilities. School-based PA programs that try to improve health, mainly through aerobic~     exercise and education, have had a small effect to date. However, the few programs that~     included resistance training as the focus showed strong improvements in health related~     measures. In this project, we will examine the effect of a female strength and conditioning~     specialist on decreasing barriers and increasing the overall health of high school girls,~     with the delivery of in-school, girls-only resistance training programs. We will see if~     physical and mental health changes with the training, and how the presence of the S & C~     specialist affects the girls' social interactions within the school. The results will help~     individuals in the education sector plan programs and services to improve overall youth and~     school health.~   "
60377|NCT02776566|"~     The purpose of this study is to demonstrate the feasibility and effectiveness of~     anticoagulation self-monitoring coupled with an educational intervention in a minority~     underserved population.~   "
60378|NCT02776553|"~     The primary aim of this study is to improve both physical fitness and sarcopenia of patients~     with ESLD who are potentially eligible for liver transplantation through a 12-week physical~     training program. Secondary aims will focus on changes in anthropometrics, body composition,~     quality of life, and metabolic profile. This is a randomized clinical trial including 50~     patients, with half allocated to the active group (physical training program) and half to~     standard of care.~   "
60379|NCT02776540|"~     Evaluate the role of loading Clopidogrel in acute ischemic stroke in improving neurological~     outcome of stroke in cases patients will be non-eligible for, or declined, treatment with or~     intravenous thrombolysis with rTPA, rTPA is not available or thrombectomy.~   "
60380|NCT02776527|"~     The main purpose of this study is to evaluate whether the Apatinib can improve the disease~     free survival (DFS) of gastric cancer patients in stage IIIB/IIIc, who had completed~     postoprative adjuvant chemotherapy. Meanwhile, the investigators also will evaluate whether~     the Apatinib can improve the overall survival (OS), estimate the quality of life of patients~     have taken the Apatinib and monitor the security of Apatinib.~   "
60381|NCT02776514|"~     This study investigates clinical outcome and imaging outcome parameters after intraarticular~     injection of steroids, platelet-rich-plasma (prp), hyaluronic acid or placebo in patients~     with early osteoarthritis of the knee joint.~   "
60382|NCT02776501|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
60383|NCT02776488|"~     Metabolic crisis is a state of energy insufficiency due to impaired mitochondrial function as~     indicated by cerebral microdialysis lactate/pyruvate ratio (LPR). We have performed safety~     analysis of glucose and sodium lactate infusions in humans and have demonstrated proof of~     concept that these fuels alter brain metabolism. We will conduct a multicenter, adaptive~     design-based, proof of concept unblinded phase 2 study of up to 3 candidate supplemental~     fuels infused over 3 hours in patients with severe traumatic brain injury undergoing standard~     of care multimodality monitoring with cerebral microdialysis.~   "
60384|NCT02776475|"~     This prospective one group cohort study seeks to investigate the effects of sacral~     neuromodulation on urinary urgency, frequency and urge incontinence are maintained after the~     simulator device is temporarily turned off for a period of four weeks.~   "
60387|NCT02776436|"~     The manufacturer recommends two different regimens of prophylactic dexamethasone to prevent~     hypersensitivity and fluid retention reactions caused by docetaxel: a 3-day regime of~     dexamethasone 8mg twice a day starting the day before chemotherapy for breast cancer and for~     prostate cancer 3 times 8mg dexamethasone on the day of docetaxel infusion, given the~     concurrent use of prednisone 2dd5mg. There is little evidence that supports this high dose~     regimen used nowadays. There is need to re-evaluate this high dosage of dexamethasone for~     three main reasons. First, dexamethasone can give side effects such as manifestation of~     latent diabetes mellitus, immunosuppression, personality changes, irritability, euphoria, or~     mania and mood swings. Second, dexamethasone is an immune suppressor, which might inhibit~     chemotherapy-induced apoptosis and compromise the efficacy of chemotherapeutic agents. Third,~     dexamethasone is a CYP3A4 inducer, which might increase docetaxel clearance. This study aims~     to evaluate the feasibility of reducing prophylactic of dexamethasone around docetaxel~     infusion.~   "
60388|NCT02776423|"~     Transurethral injection using polyacrylamide hydrogel (Bulkamid®, Contura A/S, Denmark) is an~     established treatment for stress urinary incontinence. The rates of women reporting~     improvement or cure after Bulkamid injection for stress urinary incontinence range between~     64-77% with a very low morbidity. However, the indications for use are unclear. Although~     transurethral polyacrylamide hydrogel injection is inferior to midurethral slings with regard~     to expected cure rates, the procedure is associated with very low rates of adverse events in~     general and serious adverse event in particular. As such, it may be an important alternative~     for patients where surgery is not considered a safe option either because of co-morbidity or~     because of complicated incontinence. The investigators performed a prospective study to~     determine the effects of transurethral polyacrylamide hydrogel injection in patients~     considered ineligible for midurethral sling surgery.~   "
60389|NCT02776410|"~     The purpose is to investigate young consumers' attitudes and behaviour towards sustainable~     and healthy eating by applying a multidisciplinary approach, taking into account economical,~     marketing, public health and environmental related issues. In order to achieve this goal,~     consumers' reactions on interactive tailored informational messages about sustainable from~     social, environmental and economical point of view, as well as healthy eating behaviour in a~     group of Polish young adults will be investigated. Main research questions that will be~     addressed: What is consumer's current behaviour and perception of sustainable healthy eating?~     What are factors determining consumers' reactions to messages about sustainable healthy~     eating? What are consumers' reactions on interactive tailored communication about sustainable~     and healthy eating behaviour? About 200 Polish consumers will take part in this randomized~     controlled trial. A stratified design will be used to recruit 18-30 years old adults using~     smart phones. The sample will be represented for gender and region. Participants will be~     randomly assigned to either a study or a control group. They will complete a baseline and~     follow-up survey. An application for smart phones will be developed by a professional IT~     company in order to deliver personalised messages to the participants. Intervention will take~     one month. Messages developed following the theory-linked definitions of behaviour change~     techniques will be sent to the participants every 2-3 days. The six principles of sustainable~     and healthy behaviour introduced in the campaign Livewell 2020 will be used as a base to~     communicate to consumers.~   "
60390|NCT02776397|"~     Relationship of haptoglobin phenotype to vascular function and response to Vitamin E~     supplementation in Patients with Diabetes Mellitus Type 2: The EVAS Trial~      Specific Aims:~      The phenotype haptoglobin 2-2 (Hp 2-2) is associated with higher oxidative stress,~     inflammation, LDL peroxidation and higher cardiovascular risk in patients with diabetes. We~     aim to determine whether Hp 2-2 phenotype is associated with surrogate markers of~     cardiovascular risk, inflammation, lipids and lipoprotein profile, oxidative stress, and~     endothelial cell (EC) apoptosis (in vitro study) in patients with diabetes in our population~     and whether vitamin E supplementation mitigates this risk.~      Methods:~      Screening Phase:~      We will recruit 300 patients with diabetes mellitus type 2 (100 Chinese, 100 Malays and 100~     Indians) and assess their Hp phenotype, surrogate markers of cardiovascular risk,~     inflammation, vascular biomarkers and lipids phenotype.~      In vitro Study:~      Plasma from 20 patients with Hp 2-2 phenotype and 20 patients with non Hp 2-2 phenotype will~     be studied in vitro using a haemodynamic lab-on-chip system to determine whether there is a~     difference in EC apoptosis between the two groups.~      Randomisation Phase 200 patients will be recruited to a pilot randomized controlled trial~     (RCT), stratified by Hp 2-2 phenotype status (100 Hp 2-2 and 100 non-Hp 2-2), and randomly~     allocated in a 1:1 ratio to either vitamin E 400 IU supplementation daily for 6 months or a~     placebo group. The trial will determine whether vitamin E improves the aforementioned~     surrogate markers in the Hp phenotype strata.~      Importance of proposed research to science and medicine:~      This study allows us to understand the possible mechanism of cardiovascular risk in patients~     with Hp 2-2 phenotype and to see whether vitamin E supplementation reduces this risk in a~     pharmacogenomic targeted manner.~   "
60391|NCT02776384|"~     The study aims to investigate whether disease progression in patients with chronic heart~     failure (CHF) can be assessed by new biomarkers, and determine their diagnostic value. The~     study also intends to describe comparison of echocardiography with cardiopulmonary function~     test in CHF patients, and relating these cardiac functional parameters to clinical outcome.~   "
60392|NCT02776371|"~     Helicobacter pylori (H. pylori) infects more than 50% of the population in the world(1),~     especially 47-66% in China.~   "
60393|NCT02776358|"~     Bedside clinical case learning, such for respiratory distress, represent a challenge for~     medical teachers, especially in critical conditions. In fact, this kind of learning implicate~     the presence of an appropriate case (the patient itself), framework and may be time consuming~     which could compromise the patient's safety and wellbeing.~      New pedagogic tools have emerged to strengthen the medical reasoning and the acquisition of~     knowledge. in recent years, the development of medical simulation has found a growing~     interest in the medical teaching field. Contextualization, reproducibility and reliability~     are the characteristics of high-fidelity simulation (HFS) which guarantee a lifetime~     experience of clinical conditions without putting at risk patient's safety and comfort.~      The aim of this study is to assess the impact of HFS on fifth year medical students learning~     skills in the assessement and management of an acute asthma attack in the emergency room, and~     to compares it to other modern teaching tools such as video-case~   "
60394|NCT02776345|"~     The purpose of this study is to determine whether minimally invasive treatments like~     ultrasound guided needle fragmentation with and without lavage is associated with better~     clinical outcomes compared to the subacromial bursal corticosteroid injection treatment only.~   "
60395|NCT02776332|"~     The purpose of this study is to determine how the duration of manual expression affects milk~     volumes and levels of breastfeeding self-efficacy in mothers of premature infants.~      The specific aims of this study are to determine if the duration of manual expression in~     mothers of premature infants will result in: (a) an increase in breastfeeding self-efficacy~     (b) a difference in milk volume and (c) a correlation between breastfeeding self-efficacy and~     milk volume.~   "
60398|NCT02776293|"~     Prenatal anxiety and depression are distressing for the expectant mother and can have adverse~     effects on her fetus and child. This study aimed to determine whether listening to specially~     composed songs would be an effective intervention for reducing symptoms of prenatal anxiety~     and depression over a period of 12 weeks.~   "
60399|NCT02776280|"~     This study will assess the concentration of fluoride in saliva and dental biofilm (fluid and~     solids) during and up to 2 hours after the consumption of typical Brazilian meals prepared~     with fluoridated water (0.7 ppm F) or fluoridated salt (250 mg F/kg). Typical Brazilian meals~     (rice, beans, meat with vegetables) will be prepared using fluoridated water, salt, or~     non-fluoridated water and salt. In an crossover design, twelve volunteers will eat 4.67 g of~     food/kg body weight of each meal, on fasting, during 15 min. Before the ingestion,~     unstimulated saliva and dental biofilm will be collected for determination of fluoride~     concentration. During the meal, 3 samples of the alimentary bolus (at 5, 10 and 15 min of~     mastication) will be collected for determination of fluoride concentration. Dental biofilm~     will be collected immediately after the ingestion of the meal. Saliva will then be collected~     after 5, 10, 15, 30, 60 and 120 min. All samples will be analyzed for fluoride using an~     ion-specific electrode. In order to standardize biofilm formation, during lead-in and~     wash-out periods, volunteers will: 1. brush their teeth with non-fluoride toothpaste; 2.~     refrain from brushing superior posterior teeth for 2 days before each phase; and 3. chew~     sucrose-containing chewing gum 5 times/day, for 10 min, during the 2 days prior to each~     phase. Groups will be compared by ANOVA and Tukey test.~   "
60400|NCT02776267|"~     The purpose of this study is to perform a first-in-man assessment of feasibility, exploratory~     efficacy and clinical performance of the novel Angiolite drug-eluting stent (iVascular,~     Barcelona, Spain) utilizing intracoronary optical coherence tomography (OCT).~   "
60401|NCT02776254|"~     This study seeks to create generalizable knowledge about the implementation process as well~     as the effectiveness and efficiency of a differentiated care system, by measuring patient~     health outcomes and implementation outcomes such as acceptability, feasibility, fidelity, and~     costs~   "
60402|NCT02776241|"~     The objective of this study is to measure the influence of both short term water restriction~     and high water intake on total kidney volume, measured by Magnetic Resonance Imaging (MRI)~     scan in Autosomal Dominant Polycystic Kidney Disease (ADPKD) patients.~   "
60403|NCT02776228|"~     The study deals with the prevalence of insomnia after heart surgery and the outcome of~     treatment with Benzodiazepine for this phenomena.~   "
60404|NCT02776215|"~     Open-label Study to Investigate the Pharmacokinetics and Safety of Tasimelteon in Children~     and Adolescents.~   "
60405|NCT02776202|"~     Sickle cell disease (SCD) is the most common inherited blood disorder in Saudi Arabia . Its~     clinical severity is widely heterogeneous among patients who share the same genetic mutation~     . Severe frequent pain crisis, recurrent acute chest syndrome and stroke are features of~     severe SCD. Hydroxyurea is an effective treatment of SCD as it ameliorates the severity and~     frequency of pain crisis and acute chest syndrome and decreases mortality, however, it is~     less effective in the prevention and treatment of stroke and other end organ dysfunctions .~     The only readily available cure of SCD is by hematopoietic stem cell transplantation (HSCT) .~     Most children with SCD who are treated by HSCT receive myeloablative conditioning with~     excellent results. The application of reduced intensity (RIC) and non-myeloablative (NMA)~     conditioning regimens are reserved for patients older than 16 years of age because of the~     increased risks of morbidity and mortality after HSCT6. However, infertility and gonadal~     failure after myeloablative conditioning are important barriers to the willingness of~     patients and their families to undergo HSCT . The development of an effective RIC HSCT in SCD~     that might spare the fertility of SCD patients would have obvious merit.~      With the ultimate goal of expanding this curative therapy to SCD patients, we propose to~     investigate HSCT with a RIC conditioning regimen. We will carry out a pilot study of HSCT~     from HLA matched sibling donors using thymoglobulin/fludarabine/melphalan conditioning and~     sirolimus and mycophenolate mofetil (MMF) as GVHD prophylaxis in SCD patients with severe~     complications such as stroke and other severe complications. We hypothesize that HSCT from~     HLA matched sibling using thymoglobulin/fludarabine/melphalan conditioning in SCD will~     maintain a level of stable donor chimerism that is sufficient to cure SCD with minimal~     toxicity.~   "
60406|NCT02776189|"~     MRI though not painful requires deep sedation for children due to the loud noise created.~     With deep sedation comes respiratory depression so the interest in Dexmedetomidine. For~     standardization MRI brain was chosen and also for the fact that patients usually have history~     of convulsions where drugs like ketamine may not be a good option. Patients were recruited~     after ethics committee approval. After pre-medication with intranasal midazolam 0.2 mg/kg~     body weight, Intravenous access was established and then patients were divided in two groups.~     One group received intravenous propofol 2mg/Kg and infusion of 100mcg/per kg body weight per~     minute. The other group received intravenous bolus of Dexmedetomidine 1mcg/kg over 10 minutes~     and then a infusion of Dexmedetomidine 1mcg/kg/hour.~      Primary out come was to study the recovery time of patients sedated with Dexmedetomidine~     compared to patients sedated with propofol for paediatric MRI brain. Secondary outcome were~     analysed in terms of time for induction,procedural disruptions due to awakening and~     haemodynamic stability . Follow up was done on phone for any adverse events.~   "
60407|NCT02776176|"~     The study is designed to determine if enhanced recovery after surgery (ERAS) principles could~     provide benefit for pediatric patients undergoing radical surgery for Hirschsprung's Disease~     (HD). Half of patients will receive the ERAS program, while the other half will receive the~     traditional program.~   "
60408|NCT02776163|"~     This is a non-randomized, phase II, open label study of postoperative current~     chemoradiotherapy for high-risk malignant salivary gland tumors of head and neck.The primary~     purpose of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy~     in these patients.~   "
60418|NCT02776033|"~     This is the first study with GSK2982772, a receptor-interacting protein-1 (RIP1) kinase~     inhibitor, in subjects with active plaque-type psoriasis (PsO). The primary objective will be~     to investigate the safety and tolerability of repeat oral doses of GSK2982772 60 milligram~     (mg) twice daily (BID) for 84 days in Cohort 1 and 60 mg thrice daily (TID) for 84 days in~     Cohort 2. In addition, a number of experimental and clinical endpoints will be employed to~     obtain information on the pharmacokinetics, pharmacodynamics, and efficacy in subjects with~     active PsO. There will be two Cohorts of subjects. In Cohort 1 after a screening period of up~     to 30 days, approximately 30 subjects will be randomized to receive either GSK2982772 60 mg~     BID or placebo for 84 days (12 Weeks), followed by a follow-up period (28 days). In Cohort 2~     after a screening period of up to 30 days, approximately 24 subjects will be randomized to~     receive either GSK2982772 60 mg TID or placebo for 84 days (12 Weeks), followed by a~     follow-up period (28 days). The total duration of participation is approximately 20 Weeks~     from screening to the last study visit.~   "
60409|NCT02776150|"~     Background:~      Drug resistant tuberculosis is a serious public health problem that threatens the health of~     human life and the development of society and economy. At present, the diagnosis of~     drug-resistant tuberculosis mainly depends on traditional drug susceptibility test. But it is~     limited in Mycobacterium tuberculosis slow growth speed, traditional solid drug sensitivity~     test usually need to 3 months to results, delay the development of drug resistance in~     patients with effective treatment. Probe melting curves resistance detection technology is~     the recent emergence of a new molecular biology and drug resistant tuberculosis detection~     technology, probe melting curves with different fluorescent labeled probe coverage detection~     specific to M.tuberculosis drug resistance determining region, through changes in the melting~     point of the probe hybridization, acquire mutation information of detection region, shorten~     detection time and detect nonuniform resistance.~      In this study, by selecting a nationally representative in different levels of hospitals~     jointly launched multi center, large sample clinical assessment, completed the comprehensive~     evaluation of sensitivity, specificity and health economics of drug resistant pulmonary~     tuberculosis, especially resistance to multidrug and extensively drug-resistant TB patients~     detection,in order to evaluate the rapid, accurate and economic and appropriate technology of~     drug resistance pulmonary tuberculosis detection.~      In order to accomplish the overall goal of the project, in the framework of the overall~     design, according to the principles of the core tasks are divided into four sub topics,~     namely:~      Sub topic 1 of the core mission is included in 3100 cases of smear positive pulmonary TB~     suspicious symptoms, from which selected more than 1000 cases of drug-resistant pulmonary~     tuberculosis patients, using MGIT liquid culture and drug sensitivity test as the gold~     standard,evaluate the sensitivity and specificity of probe melting curves in detction of~     resistance of four kinds of anti tuberculosis drug to Mycobacterium tuberculosis; Sub topic 2~     core task is including at least 500 cases of culture positive pulmonary tuberculosis patients~     and treatment follow-up, using MGIT liquid culture and drug sensitivity test as the gold~     standard, evaluate the application value of probe melting curves for monitoring spectrum~     changes of drug resistance of Mycobacterium tuberculosis during pulmonary tuberculosis~     treatment.~      The core mission of sub topic 3 is to project implementation of hospital as the research~     site,acquire the cost-effect evaluation and analysis by comparing probe melting technology~     with Mycobacterium tuberculosis MGIT liquid culture, and drug sensitivity test with xpert~     MTB/RIF technology.~   "
60410|NCT02776137|"~     This is a non-randomized, phase II, open label study of postoperative concurrent~     chemoradiotherapy with docetaxel for high-risk squamous cell carcinoma of the head and~     neck(HNSCC).The primary purpose of this study is to evaluate the efficacy and safety of~     concurrent chemoradiotherapy with docetaxel in HNSCC patients.~   "
60411|NCT02776124|"~     Malnutrition is very common in locally advanced nasopharyngeal carcinoma(NPC) patients~     undergoing current chemoradiotherapy (CRT) due to dysphagia, mucositis, nausea and other~     treatment-related problems. Malnutrition is associated with lower physical functioning, lower~     immune status, more severe (grade III/IV) late RT-induced toxicities, treatment interruption~     of chemo(radio)therapy, lower chemotherapy response rates, hospital readmission, impaired~     quality of life (QoL), and increased mortality. Although the international guidelines~     recommend early nutritional support in the presence of nutritional risk, the best type of~     nutritional intervention is still unclear. Individualized dietary counseling showed~     beneficial effects in nutritional intake, nutritional status and QoL in head and neck cancer~     patients undergoing RT or CRT-treatment; oral nutritional supplements (ONS) was most~     acceptable in Chinese NPC patients. Previous nutritional intervention trials in head-neck~     cancer patients have been conducted on small samples and did not clarify the role of oral~     nutritional supplements (ONS). Accordingly, although current guidelines recommend as grade A~     the use of ONS associated with dietary counseling for head-neck cancer patients undergoing~     RT, the efficacy of this nutritional intervention still needs to be evaluated in adequately~     sized and randomized clinical trials for Chinese NPC patients.~   "
60412|NCT02776111|"~     The field of genomics is an exciting new field being applied in medicine. Its use in treating~     some cancers, sepsis and burn patients has been very promising. As knowledge of genomics and~     application of microarrays expands, researchers are developing more intelligent ways to~     provide individualized care for patients. The plan of this research study is to apply the use~     of genomics as a tool for transplant in several capacities.~      This research study is designed to develop methods of isolating relevant cell types via~     microarray plates, then extracting mRNA samples of those cell types and capturing their~     genetic profile. This will be done with the blood of up to ten healthy donors. Once this~     ability has been demonstrated, the next step will be to use these testing in several~     capacities in transplant patients. The research study plan involves following the genetic~     profile of 26 kidney transplant patients. One group will be followed prospectively starting~     at baseline, and then at various set time points. A second group will be sampled with the~     occurrence of clinical events. These events include viral, bacterial, and fungal infection,~     WBC < 2.5 or biopsy proven rejection episodes or normal graft function. Thus, the intention~     of the study is to demonstrate how immunosuppression alters the expression of this genetic~     expression of these T cells. In doing so, the study will provide a better understanding of~     the specific and true immunosuppressed state for any given patient.~   "
60413|NCT02776098|"~     This study will investigate the link between glucose abnormalities and elements critical to~     muscle function including mass, composition and energy metabolism. the primary goal of the~     study is to determine whether Cystic Fibrosis (CF) disease is associated with muscle~     dysfunction, especially in the presence of glucose intolerance. This is a longitudinal cohort~     study of 3 main groups: CF subjects without Cystic Fibrosis-related diabetes (CFRD), healthy~     matched controls and CF subjects with newly diagnosed CFRD started on insulin therapy.~   "
60414|NCT02776085|"~     Bedside ultrasound in the emergency department is useful for quick assessments of patients.~     One growing use is to measure the optic nerve sheath diameter of patients for whom increased~     pressure in the head is a concern. This study will look at the optic nerve sheath diameters~     of a specific population of pediatric patients with shunts that drain extra fluid from their~     heads.~   "
60415|NCT02776072|"~     The primary objective of the study is to evaluate the real-world clinical effectiveness, as~     measured by the proportion of participants relapsed at 12 months, in participants treated~     with dimethyl fumarate (DMF).~      Secondary objectives of the study are: To evaluate the real-world clinical effectiveness, as~     measured by the proportion of participants relapsed at 12 months, in participants treated~     with DMF, glatiramer acetate (GA), teriflunomide, or fingolimod both in the overall~     participant cohort and in a subset of participants who were naïve to disease-modifying~     therapy (DMT) and were diagnosed with multiple sclerosis (MS) within 3 years of starting the~     index therapy; To compare relapse activity, defined as annualized relapse rate (ARR), among~     participants treated with DMF, GA, teriflunomide, or fingolimod; To compare MS-related~     hospitalizations among participants treated with DMF, GA, teriflunomide, or fingolimod; To~     compare intravenous corticosteroid use among participants treated with DMF, GA,~     teriflunomide, or fingolimod.~   "
60416|NCT02776059|"~     This is a multi-center, prospective, randomized trial of standard of care vs. standard of~     care + pegfilgrastim (Neulasta®) among patients with a clinical diagnosis of alcoholic~     hepatitis and DF≥32.~   "
60417|NCT02776046|"~     The iPROVE-O2 trial aims at comparing the efficacy of high and conventional FiO2 within a~     perioperative individualized ventilatory strategy to reduce the overall incidence of SSI.~   "
60420|NCT02776007|"~     The Libre- flash glucose monitoring system is an episodic real-time data on demand device.~     This means that patients can measure their glucose level when they choose by scanning the~     device, while at the same time a sensor automatically measures and continuously stores~     glucose readings day and night. Every scan shows the current glucose reading and the last 8~     hours of glucose. There are no alarms and the system does not require calibration.~      In the present study we aim to evaluate treatment satisfaction and comfort using the Libre~     flash glucose monitoring system compared to conventional Self Measurement of Blood Glucose~     (SMBG) in adolescents with type 1 diabetes that discontinued using continuous glucose~     monitoring.~      The second aim of the study is to evaluate the rate of use and the impact of Libre use~     compared to Self-Measurement of Blood Glucose among adolescents who are sub-optimally~     controlled and stopped using Continuous Glucose Monitoring. The study is an investigator~     initiated study, single-center, randomized, parallel study of 12 weeks with an optional~     cross-over 12 weeks extension period .~   "
60421|NCT02775994|"~     Periodic Fever, Aphthous stomatitis, Pharyngitis and cervical Adenitis (PFAPA) is one of the~     most common, least explored periodic fever syndrome in childhood. This study aims to~     investigate whether a single dose of an interleukin beta (IL-1) antagonist, Canakinumab will~     be able to abort PFAPA flares in patients who experience a flare in an average of 2 weeks or~     less. This will be a single arm open label pilot study. 10 patients will be recruited from 1~     center (Pediatric rheumatology unit -Schneider children's medical center of Israel).~      Patients in ages 2-10 years old who are diagnosed with PFAPA according to clinical criteria~     at least 3 months prior to enrollment and who are under regular care for this disease (single~     dose of glucocorticoids during flare) and who suffer from more than 4 PFAPA flares for the~     last 2 months, will be screened for this study. In the second documented flare, patients will~     be enrolled to receive a single dose of subcutaneous (SC) Canakinumab 4 mg/kg. The primary~     outcome is defined as - 50% reduction in PFAPA flares for the next 2 consecutive months as~     reported by the patient (use of diary) and documented by the patient primary care physician~     and/ or the researcher in a monthly follow up visits. Secondary outcome measure are define as~     time to flare (days) and Parent/patient quality of life assessment measured by 100mm visual~     analog scale (VAS).~   "
60422|NCT02775981|"~     The primary objective of this study is to evaluate the potential effect of hepatic impairment~     on the systemic pharmacokinetics of RX0041-002 following single dose intranasal~     administration. The secondary objective is to evaluate the safety and tolerability of~     intranasal RX0041-002 in subjects with normal hepatic function and hepatic impairment.~   "
60423|NCT02775968|"~     This study is based on the hypothesis that the pharmacokinetics of antibiotics in children is~     different from adults. Cephalosporins and macrolide antibiotics are the common drugs for~     children with community acquired pneumonia, the investigators aim to study the population~     pharmacokinetics of cephalosporins and macrolide antibiotics in children receiving the drug~     for treatment of community acquired pneumonia, and to correlate it with treatment~     effectiveness and incidence of adverse effects.~      Potential Impact: This novel knowledge will allow better and more rational approaches to the~     treatment of community acquired pneumonia. It will also set the foundation for further~     studies that will be able to test improved therapies that may increase treatment response in~     vulnerable children.~   "
60424|NCT02775955|"~     The primary objective of this study is to evaluate the potential effect of renal impairment~     on the systemic pharmacokinetics of acute Intranasal RX0041-002. The secondary objective is~     to evaluate the safety and tolerability of acute Intranasal RX0041-002 in subjects with~     normal renal function and severe renal impairment.~   "
60425|NCT02775942|"~     A dose escalating study with 3 different dosing regimens of the studied vaccine (IPOVAC-~     POLYVAC-Vietnam) and a licensed vaccine (IMOVAC-Sanofi Pasteur- France) is conducted in~     Vietnamese children, aged 2 months and above to assess the safety and immunogenicity. Two~     hundred and forty children are enrolled and placed randomly into 4 groups (60~     children/group), each of which receive 3 doses of vaccine subcutaneously, at 4 week interval.~     Safety issues included immediate reaction at the site of injection and systemic reaction~     within 30 min of administration, within 7 days after each dose, unexpected event occur within~     30 days of each dose, SAE (from start of dose 1 to 30 days after dose 3), blood cell count,~     urea, ALT,AST. Immunogenicity outcomes include seroconversion of neutralising antibodies for~     each of vaccine serotypes.~   "
60426|NCT02775929|"~     The purpose of this protocol is to determine user preferences for antiretroviral therapy~     (ART) for HIV-1 infected partners and pre-exposure prophylaxis (PrEP) HIV-1 un-infected~     partners and to optimize targeted delivery and sustained use of these interventions.~   "
60427|NCT02775916|"~     This Study is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary~     therapeutic efficacy of oral administrations of CDZ173, a selective PI3K Delta inhibitor, for~     12 weeks, in patients with primary Sjögren's syndrome. Data from this study will provide~     basis for further development of the compound for the treatment of primary Sjögren's~     syndrome.~   "
60428|NCT02775903|"~     This is a Phase 2, multicenter, randomized, parallel-group, open-label study consisting of 3~     phases: Screening, Treatment, and Follow-up.~      To confirm the safety, ie, the absence of overlapping toxicities of the combination treatment~     regimen, an early safety monitoring will be performed based on approximately the first 12~     subjects randomized.~      A total of approximately 72 subjects will be included in the Myelodysplastic syndromes (MDS)~     cohort and approximately 110 subjects in the Acute Myeloid Leukemia (AML) cohort.~   "
60441|NCT02775734|"~     This prospective randomized placebo-controlled double blind clinical trial will conducted in~     Ain Shams University maternity Hospital including 120 women diagnosed with clomiphene citrate~     resistant polycystic ovary syndrome. After laparoscopic ovarian drilling, they will be~     randomized to either receiving 50 mg oral clomiphene citrate twice daily and oral NAC 1,200~     mg/day for 5 days starting from cycle day 2 to cycle day 6 (group 1 = 60 patients) or~     clomiphene citrate only (group 2 = 60 patients). The primary outcome will be biochemical~     pregnancy rate, secondary outcomes include Clinical pregnancy rate, ovulation rate, live~     birth rate, number of follicles ≥ 18 mm and endometrial thickness at triggering ovulation,~     mid- luteal sub-endometrial blood flow indices, and incidence of side effects.~   "
60654|NCT02772965|"~     The purpose of this study is to determine whether adding low dose methotrexate to anti -TNF~     therapy is more effective than treatment with anti-TNF therapy alone in inducing and~     maintaining steroid-free remission for children with Crohn's Disease.~   "
60429|NCT02775890|"~     This is a clinical research protocol to determine the feasibility of assessing lead levels in~     hunters who use lead projectiles. This study will determine if it is possible to perform an~     interventional double-blind placebo-controlled study of lead levels in hunters using lead or~     lead-free projectiles following consumption of self-harvested wild game. The hypothesis for~     the subsequent study is that minute lead particles from shrapnel dispersed through the animal~     during harvest are ingested and result in increased lead serum levels. This current~     observational study establishes if this conclusive interventional study is possible through~     establishing if hunters using lead projectiles in New Zealand have elevated lead levels after~     eating animals harvested with lead projectiles. This study will be conducted in compliance~     with the protocol, Good Clinical Practice Standards, associated regulations and institutional~     research requirements.~      This study aims to assess if hunters eating meat shot with lead projectiles experience~     elevated lead levels. Hunters will be asked to provide blood samples 2-4 days after they eat~     meat harvested with lead bullets and provide a subsequent sample when they have abstained~     from eating wild game harvested with lead bullets. We have chosen to use deer as the species~     for this study to reduce variation and New Zealand is the ideal place to conduct this study~     because of year-round hunting of deer. This design will allows paired testing of subject lead~     levels.~   "
60430|NCT02775877|"~     The purpose of this study is to study the effects of letrozole and sequential clomiphene in~     ovulation and pregnancy in PCOS patients.~   "
60431|NCT02775864|"~     The study is a retrospective cohort study of adults with schizophrenia that will compare~     outcomes of new users of alternative psychotropic medication strategies using 10 years of~     Medicaid data. The primary comparative effectiveness analyses will focus on subgroups of~     patients with schizophrenia facing common clinical situations.~   "
60432|NCT02775851|"~     This pilot phase II trial studies how well pembrolizumab works in treating patients with~     desmoplastic melanoma (DM) that can or cannot be removed by surgery. Monoclonal antibodies,~     like pembrolizumab, may block specific proteins which may strengthen the immune system and~     control tumor growth.~   "
60433|NCT02775838|"~     Aim of this clinical study is to establish a novel technique, the so called intraoperative~     fluorescence angiography, for kidney graft perfusion visualization during the transplant~     procedure.~   "
60434|NCT02775825|"~     End-of life care is one of the principle components of cancer care. Measurement of the~     quality of care provided for end-of-life cancer patients is an important issue. Recently~     there has been an increased emphasis on measuring and monitoring the quality of cancer care~     for the purpose of improving clinical practice. Despite increasing attention paid to~     end-of-life care in recent years, many studies have described difficulties in the final phase~     of life, including problems with access to hospice, inadequate symptom management, care~     giving burdens, care mismatched with patient preferences, and inappropriate resource use.~     Measuring quality of life is an important issue for monitoring clinical practice and~     improving outcome. Although patient assessment is the best quality measure, it is impractical~     to measure the quality of end-of-life care because of the difficulties of accurate~     prognostication for end-of-life and many patients are too ill to provide assessments. In~     contrast, several recent studies developed quality indicators (QIs) of palliative and~     end-of-life care, which assess the quality from existing sources such as administrative data~     or medical chart data.~   "
60435|NCT02775812|"~     This phase I trial studies the side effects and best dose of pembrolizumab when given~     together with cisplatin and intensity-modulated radiation therapy, in treating patients with~     stage III-IV squamous cell carcinoma of the head and neck. Monoclonal antibodies, such as~     pembrolizumab, may block tumor growth in different ways by targeting certain cells. Drugs~     used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Intensity-modulated radiation therapy uses high-energy x-rays to kill tumor cells~     and shrink tumors. Giving pembrolizumab with cisplatin and intensity-modulated radiation~     therapy may work better in treating patients with squamous cell carcinoma of the head and~     neck.~   "
60436|NCT02775799|"~     Registration of all sarcoma patients treated at a specialized sarcoma center in Switzerland.~   "
60437|NCT02775786|"~     This is a prospective cohort study in participants with pancreatic adenocarcinoma who are~     undergoing surgical resection. Participants will have up to two magnetic resonance imaging~     (MRI) scans with and without intravenous contrast. The MRI will be performed using either an~     extracellular contrast agent or using a macromolecular contrast agent. These contrast agents~     are routinely used in body MRI and are on formulary at this institution. Parameters will be~     compared to histopathology measures of mean vascular density and grade of fibrosis,~     respectively. The purpose is to establish a standard protocol for future clinical trials of~     treatments that would use MRI parameters as quantitative markers of treatment effect.~   "
60438|NCT02775773|"~     The purpose of this study was to evaluate that the tranexamic acid (TXA)Intravenous and oral,~     is equivalent oxytocin (OXY),intramuscularly, in reducing the blood loss in post partum~     period (mL) in patients at the end of pregnancy ( 37-42 w ) at low risk of post partum~     hemorrhage (PPH). The PPH means a blood loss equal to or greater than 500 ml after a vaginal~     delivery (the bleeding is defined severe if it exceeds 1000 mL). PPH is called primary when~     blood loss arose within 24 hours after birth.~   "
60439|NCT02775760|"~     The overall goal of this study is to examine how regular exercise affects brain function,~     spatial memory, and virtual navigation. Participation in this research study will take~     approximately 4 months.~   "
60440|NCT02775747|"~     There is limited application of the use of PRP in obstetrics, therefore there is a need for~     assessment if it is efficacy in improving skin wound healing in cesarean section.~   "
60442|NCT02775721|"~     Poor nutritional status and malnutrition are prevalent for patients undergoing treatment for~     head and neck cancer. Inadequate dietary intake is multi factorial, with patients~     experiencing dysphagia and or anorexia caused by various cancer treatments. Current standard~     practice utilizes Gastrostomy Tube placement to manage adverse nutritional effects related to~     Head and Neck cancer treatment.~   "
60443|NCT02775708|"~     The purpose of this study is to support development of PillCam Endoscopy System applications.~   "
60447|NCT02775656|"~     The purpose of this observational follow-up study is to collect data systematically on~     pregnancies and offspring of women who become pregnant while participating in a Certolizumab~     Pegol (CZP) study or whose pregnancies have otherwise been reported to UCB due to potential~     CZP exposure during pregnancy.~   "
60448|NCT02775643|"~     This is an observational, non-therapeutic study to collect clinical and molecular information~     of pediatric patients with childhood melanocytic lesions.~      PRIMARY OBJECTIVE: To perform a comprehensive molecular analysis of samples either from~     paraffin embedded and/or frozen tissue from patients with pediatric melanocytic lesions~     (including melanoma, spitzoid melanoma, congenital melanoma, melanoma arising in giant nevi).~      SECONDARY OBJECTIVE: To collect minimal information on patients treated with adjuvant or~     systemic therapies according to National Comprehensive Cancer Network (NCCN) guidelines.~   "
60449|NCT02775630|"~     Bronchoscopy is an examination performed routinely in pulmonology. This exam is considered as~     uncomfortable by nearly 60% of patients, especially due to respiratory blocking sensation,~     cough and nausea it causes, despite the use of a local anesthetic. Conversely, this~     examination is rarely performed under general anesthesia in hospitals in France, because it~     lengthens the duration of the procedure, increases its cost and can be dangerous for the~     respiratory failure patient.~      Hypnosis is an altered state of consciousness between wakefulness and sleep, which can cause~     the patient to ignore the reality in which he is focusing his attention on his imagination,~     reducing his anxiety, his painful or unpleasant perceptions and their memorization.~      The hypnosis benefit has already been evaluated in the control of pain and anxiety in many~     medical situations, surgical, obstetric and dental. In endoscopy, the results are mixed. In~     bronchoscopy, hypnosis has, to our knowledge, not been evaluated.~      In a preliminary study in the endoscopy unit of the Hospital Saint Joseph, involving 66~     patients, investigators showed that bronchoscopy was poorly tolerated in more than half of~     patients and that this poor tolerance was correlated to the level anxiety of patients, but~     75% of patients surveyed would prefer the waning redo the examination in the same conditions~     if their health required it, rather than using a general anesthetic. Investigators then~     hypothesized that hypnosis would improve tolerance bronchoscopy under local anesthesia,~     without the need for general anesthesia.~   "
60450|NCT02775617|"~     This is an open-label prospective community intervention trial to assess the impact of~     community mass treatment with azithromycin for yaws and ivermectin for scabies, on non-yaws~     bacterial skin infections.~      Communities will be randomised to receive standard treatment for both yaws and scabies either~     in parallel (site 1) or in sequence (site 2).~      Treatment of yaws:~      Single dose of Azithromycin (30mg/kg, max 2G).~      Treatment of scabies:~      Either an oral dose of Ivermectin (200μg/kg) or permethrin cream for those with a~     contraindication to Ivermectin (WT<15kg, pregnant or breastfeeding women) given in 2 doses~     7-14 days apart.~      Investigators will complete a clinical and microbiological assessment of bacterial skin~     disease at baseline and at 12 months to assess the impact of treatment on the prevalence of~     bacterial infection and the emergence of antimicrobial resistance.~      Primary Outcome~        1. Difference in the change in prevalence of impetigo between baseline and 12- months~          between the parallel and the sequential treatment arms.~           Secondary Outcomes~        2. Change in the proportion of swab samples from which S. pyogenes is cultured between~          baseline and follow-up in the two arms~        3. The proportion of samples from which a drug-resistant isolate of S.pyogenes is cultured~          in the two arms~   "
60451|NCT02775604|"~     The purpose of this study is to assess the feasibility and potential impact of video analysis~     of footage taken with a GoPro camera video in comparison to a homeowner checklist or gold~     standard home assessment as a means of detecting home fall hazards.~      Investigators hypothesize that the assessment of homes for fall hazards with a GoPro camera~     will be better than a homeowner paper checklist in hazard identification.~   "
60452|NCT02775591|"~     The purpose of this study is to determine whether DA-9701(Motilitone) is effective and safe~     for the treatment on health-related quality of life in Parkinson's disease (PD) patients with~     gastrointestinal symptoms.~   "
60453|NCT02775578|"~     As the end stage of almost all cardiovascular diseases, heart failure has become an~     increasingly common cause of cardiovascular morbidity and mortality worldwide. In China,~     coronary artery disease (CAD) has become the main cause of heart failure in recent years. CAD~     combining with heart failure usually predicts poor outcome, with coronary revascularization~     the most universally used therapy. However, the difference of several types of such therapy~     has less well been compared.~      Thus, the study mainly aims to compare different types of coronary revascularization~     therapies such as Percutaneous Coronary Intervention (PCI),Coronary Artery Bypass Grafting~     (CABG) as well as Hybrid Coronary Revascularization (HCR), and also make the optimization~     strategy especially in patients with heart failure.~      The study also aims to investigate whether disease progression in patients with chronic heart~     failure (CHF) can be assessed by new biomarkers and determine their diagnostic and prognostic~     value, relating several cardiac functional parameters to clinical outcome.~   "
60454|NCT02775565|"~     This is a retrospective, record-based study of approximately 100 patients across up to 12~     centers within the United States. All patients who have been treated with the AngioVac Venous~     Drainage Cannula and the Extracorporeal Circuit will be considered for study participation.~     Eligible subject must meet all of the inclusion criteria and none of the exclusion criteria~     to be considered enrolled in the study. The purpose of the study is to describe initial~     experience with the AngioVac Venous Drainage Cannula and the Extracorporeal Circuit.~   "
60455|NCT02775552|"~     Alive & Thrive is an initiative that aims to scale up nutrition to save lives, prevent~     illness, and ensure healthy growth and development through improved infant young child~     feeding (IYCF) practices. The purpose of this study is to evaluate whether the Alive & Thrive~     intervention package, consisting of interpersonal communication, community mobilization~     activities, and radio campaign, can increase complementary feeding practices (minimum dietary~     diversity and minimum meal frequency) while sustaining exclusive breastfeeding rate among~     children less than two years of age. The impact evaluation uses a cluster-randomized design~     where 20 geographic clusters (woredas/districts) were randomized to two study arms - 10~     intervention areas and 10 comparison areas. Repeated cross-sectional baseline and endline~     surveys will be used to assess program impact.~   "
60457|NCT02775526|"~     This prospective interventional randomized controlled trial will recruit women with MUI~     scheduled for surgical treatment where patients will be randomized to either Burch~     colposuspension, TOT or TVT. Regular postoperative follow up will be planned for at least 2~     years. The primary outcome measures will be the objective and subjective cure rates.~   "
60458|NCT02775513|"~     Loss-of-function mutations in voltage-gated potassium channels cause long QT syndrome (LQTS)~     due to a prolonged cardiac repolarisation phase. Hypoteses: patients with loss-of-function~     mutations also exhibit altered hormone release upon glucose ingestion.~   "
60459|NCT02775500|"~     The purpose of the Apremilast Pregnancy Exposure Registry is to monitor planned and unplanned~     pregnancies exposed to apremilast and to evaluate the safety of this medication relative to~     specified pregnancy outcomes, and to evaluate potential effects of prenatal apremilast~     exposure on infant health status through one year of age.~   "
60460|NCT02775487|"~     Primary objective of this project is to measure the impact of passive control and active~     control systems on indoor pollution that is directly or indirectly related to ambient air~     pollution (smog). The first goal will be to measure baseline parameters for 50 homes,~     including information about the building, ventilation characteristics, pollution levels~     (indoors and outdoors), and occupant survey information. In a subset of these homes, either~     passive or active control systems will be installed and the impact of these systems on indoor~     concentrations. Participants will be enrolled on a rolling basis (5-15 persons studied at a~     given point in time) over a 16-month period. Participants will be followed for approximately~     5 weeks and data obtained at three points in time: at enrollment (day 1 of study), after 1~     week (baseline verification) and after four weeks with the control system in the home (at the~     end of study week 5).~   "
60461|NCT02775474|"~     The recent increase in obesity has led to an increase in the need for bariatric surgery. In~     this group of patients the postoperative pain management is of vital importance. One strategy~     to improve postoperative analgesia is the use of intraoperative methadone, specially in those~     patients which regional anesthesia is not feasible. There is evidence that the use of~     intraoperative methadone can lead to a analgesia lasting 24 to 36 hours, while not associated~     with increased side effects when compared to other opioids with short or intermediate~     duration of action. In this study the investigators will evaluate the efficacy of~     intraoperative methadone in reducing postoperative pain and opioid consumption.~   "
60462|NCT02775461|"~     The purpose of this study is to establish a registry of patients with pancreatic diseases.~     Patients included in the registry may include those with: pancreatic cancer, precancerous~     lesions of the pancreas, inflammatory lesions of the pancreas, cystic lesions of the~     pancreas, and patients at high-risk of pancreatic cancer such as those with a family history~     of pancreatic cancer or with a family history of a syndrome known to be associated with~     pancreatic cancer. Pancreatic cancer is the fourth leading cause of death from cancer in the~     United States. However, little is known about the development of pancreatic cancer and~     pancreatic diseases in individuals with the above conditions. Knowledge of how family~     history, environmental exposures, and inflammatory lesion of the pancreas contribute to the~     development of pancreatic cancer and pancreatic diseases is essential.~      You may qualify to take part in this research study because you have inflammation in the~     pancreas, a pancreatic cyst, pre-cancerous lesions of the pancreas, pancreatic cancer, a~     family history of pancreatic cancer, or a family history of a syndrome known to be associated~     with pancreatic cancer.~      We will also be collecting a blood sample from all participants for DNA isolation. Sometimes~     we are born with genes or DNA that give us an increased or decreased chance of developing an~     illness later in life. Genetic material will be isolated from your blood for further study.~     You may also choose to provide additional blood samples for serum and plasma extraction.~     Serum and plasma are components of the blood which can be used to measure indicators of~     disease in the blood, called biomarkers,for pancreatic diseases. Clinical data and biological~     specimens contained in this study may be used for a wide variety of future related studies to~     the cause, diagnosis, outcome and treatment of pancreatic cancer.~      Funds for conducting this research are provided by Mount Sinai.~   "
60463|NCT02775448|"~     Metabolic disorders including hypercholesterolemia and hypertriglyceridemia are present in~     climacteric women. Carduus marianus is a homeopathic medicine that traditionally has been~     used for hepatic diseases. It has been used for reducing hypercholesterolemia and~     hypertriglyceridemia also. The aim of this study is to investigate the most effective dose of~     Carduus marianus in centesimal scale (6cH, 12cH, 30cH, placebo) plus diet and exercise for~     reducing hypertriglyceridemia and/or hypercholesterolemia in climacteric women.~   "
60464|NCT02775435|"~     This is a study of carboplatin and paclitaxel or nano particle albumin-bound paclitaxel~     (nab-paclitaxel) with or without pembrolizumab (MK-3475, KEYTRUDA®) in adults with first line~     metastatic squamous non-small cell lung cancer (NSCLC).~      The primary hypotheses are that treatment with pembrolizumab prolongs: 1) Progression-free~     Survival (PFS) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as~     assessed by a blinded central imaging vendor compared to placebo, and 2) Overall Survival~     (OS).~   "
60465|NCT02775422|"~     Comparison of the sensibility and specificity of 3 different serological tests and evaluation~     of chicken pox immunity in pregnant women.~      Secondary goals :~        -  Correlation memory / Immunity;~        -  Prevalence of VZV immunity in pregnant women;~        -  Evaluation of cellular and humoral immunity in cases with discrepancy between tests or~          between test and memory;~        -  Evaluation of acceptability of vaccination in the post partum period in non immune~          patients.~      Methods Not randomized prospective study,~      Number of patients : 400 Duration : 36 months Inclusion criteria : pregnant women >18years~     old, agree to participate (written consent) Exclusion criteria: auto immune disease, HIV +,~     grafted patients~   "
60466|NCT02775409|"~     This study is for women scheduled to have immediate breast reconstruction following~     mastectomy using a tissue expander. The primary purpose of this study is to learn whether~     there are differences in the outcome between placing the tissue expander above the muscle or~     below the muscle. The study will evaluate pain, wellbeing, and overall satisfaction with~     reconstruction. A secondary purpose is to learn whether there are differences in~     complications and costs between the two locations.~   "
60467|NCT02775396|"~     With the increasing reliance on tablet computers and smartphones in daily life, it is~     important to determine whether and how the prolonged usage of these handheld digital devices~     influences the working habits and refractive status. This study aimed to determine the~     effects of wearing conventional single-vision lenses vs. new progressive addition lenses on~     the working distance and refractive status while playing interactive video game in Chinese~     pre-presbyopic adult computer users.~   "
60468|NCT02775383|"~     Multi-center study enrolling patients suspected or newly diagnosed with myelodysplastic~     syndromes (MDS), myelodysplastic syndromes/myeloproliferative neoplasms (MDS/MPN) overlap~     disorder, or idiopathic cytopenia of undetermined significance (ICUS). Participants will be~     followed long term. Clinical data, blood, and tissue samples will be collected to establish a~     biorepository to facilitate the study of the natural history of MDS.~   "
60469|NCT02775370|"~     This is a non-randomized, phase II, open label study of Apatinib Mesylate in patients with~     Head and neck recurrent/metastatic adenoid cystic carcinoma (ACC). The primary purpose of~     this study is to evaluate the efficacy and safety of Apatinib Mesylate in patients with ACC.~   "
60470|NCT02775357|"~     The study is aimed at testing whether use of a new index to measure risk for HIV in the~     context of HIV testing and counseling will increase demand for safe male circumcision (SMC)~     services among HIV-negative non-muslim men in Rakai. We will also study whether use of the~     index leads to positive sexual behavioral modifications among men. The study will also~     measure acceptability of the index among men.~   "
60471|NCT02775344|"~     This is a prospective randomized study involving 124 patients. All participates will be given~     written information on 3D laparoscopy. They will be randomized according to~     computer-generated random sequence into two groups, 2D and 3D group. The operation will then~     be performed either using 2D or 3D laparoscopy. Surgeons are allowed to change to the other~     type of laparoscopy if difficulty encountered. After the operation, the surgeons will be~     required to fill in a questionnaire self-evaluating the performance using Global rating scale~     component of the intraoperative assessment tool (GOALS), any discomfort encountered, any need~     for change of laparoscopy and their preference on the type of laparoscopy.~      The level of complexity of the operation, duration of operation, blood loss and complications~     will be recorded.~   "
60472|NCT02775331|"~     This study aims to investigate whether use of interactive worktime planning tools that~     support work-time control (possibilities to influence individual shift rosters i.e.~     self-rostering) and guide for health-supporting shift ergonomics will improve health and~     well-being among shift workers. Effects of the worktime planning tools will be studied in a~     quasi-experimental design in the Finnish public sector. Health and well-being at baseline~     (2012-2015), will be compared to follow-up data in 2016-2017 based on questionnaire and~     pay-roll based objective working hour and sickness absence data among those who a) use an~     interactive self-rostering software with a shift ergonomics sub-tool, b) whose working hours~     are designed with a non-interactive shift planning software with the shift ergonomics~     sub-tool and c) whose working hours are designed with a non-interactive shift planning~     software without the shift ergonomics sub-tool.~   "
60473|NCT02775318|"~     The present study has been designed to assess the efficacy and safety of Stellate Ganglion~     Block (SGB) in relieving symptomatic cerebral vasospasm following aneurysmal clipping. The~     effect was assessed by both Digital Subtraction Angiography(DSA) and Transcranial Doppler~     (TCD).~   "
60474|NCT02775305|"~     Frailty is a syndrome characterized by decreased reserve and diminished resistance to~     stressors. The proposed research will evaluate the association of frailty with chronic kidney~     disease (CKD). The prevalence of frailty increases with age and with CKD, but studies are~     needed to determine whether frailty is associated with worsening of CKD and whether~     intervention to treat frailty can improve physical functioning and health-related quality of~     life (HRQOL) as well as slow progression of CKD.~   "
60475|NCT02775292|"~     This phase I trial studies the side effects and the best dose of nivolumab when given~     together with gene-modified T cells and vaccine therapy in treating patients with solid~     tumors that express the cancer-testes antigen NY-ESO-1 gene AND have spread from where it~     started to nearby tissue or lymph nodes (locally advanced) or distant organs (stage IV). T~     cells are a special type of white blood cells (immune cell) that have the ability to kill~     cancer cells. Nivolumab may block PD-1 which is found on T cells and help the immune system~     kill cancer cells. Placing a modified gene for the NY-ESO-1 T cell receptor (TCR) into the~     patients' T cells in the laboratory and then giving them back to the patient may help the~     body build an immune response to kill tumor cells that express NY-ESO-1. Dendritic cells are~     another type of blood cell that can teach other cells in the body to look for cancer cells~     and attack them. Giving a dendritic cell vaccine with the NY-ESO-1 protein may help dendritic~     cells teach the immune system to target cancer cells expressing that protein, and further~     help the T cells attack cancer. Giving nivolumab together with gene-modified T-cells and~     dendritic cell vaccine may teach the immune system to recognize and kill cancer cells that~     express NY-ESO-1.~   "
60476|NCT02775279|"~     Compelling epidemiological evidence indicates that alterations length of telomere, are~     associated with the initiation and development of ischemic heart disease. This study was~     undertaken to investigate whether mtDNA copy number in peripheral blood leukocyte could be~     used as a risk predictor for acute coronary syndrome.~   "
60477|NCT02775266|"~     To evaluate the effectiveness of non surgical periodontal therapy in addition to~     antioxidant(ALA) on resistin levels in patients with type 2 diabetes and periodontal disease~   "
60478|NCT02775253|"~     Adipose tissues, which include white adipose tissue (WAT) and brown adipose tissue (BAT),~     play an essential role in regulating whole-body energy homeostasis. Recent studies also~     reveal the presence of a subset of cells in WAT that could be induced by environmental or~     hormonal factors to become brown-like cells, and this beigeing process has been suggested~     to have strong antiobesity an antidiabetic benefits. More recently, one study showed that~     Short-term cold acclimation (10 days) improved insulin sensitivity, but did not activate the~     browning of subcutaneous white adipose in patients with type 2 diabetes mellitus. Here,~     investigators hypothesize that a chronic cold acclimation can activate the the browning of~     subcutaneous white adipose in patients with type 2 diabetes mellitus.~   "
60479|NCT02775240|"~     The purpose of this study is to determine how an investigational treatment (maribavir) is~     handled by the body when administered with two already approved drugs (digoxin and~     dextromethorphan). The study will also look at the safety and tolerability when maribavir is~     coadministered with digoxin and dextromethorphan versus digoxin and dextromethorphan alone.~   "
60480|NCT02775227|"~     Pancreatic resections carry a high risk for complications, especially pancreatic fistula.~     Both hydrocortisone and pasireotide have been shown to be effective in reducing complications~     in earlier RCTs. The aim of this study is to compare the effectiveness and safety of these~     two drugs in preventing complications of pancreatic surgery.~   "
60481|NCT02775214|"~     The purpose of this study is to compare two different ways of placing breathing tubes for~     surgery. Both ways are used currently to place breathing tubes and are safe and effective.~     This study seeks to determine if one way is better than the other for infants with pyloric~     stenosis.~   "
60482|NCT02775201|"~     The plantaris tendon is recognised as an important factor in non-insertional Achilles~     tendinopathy (NIAT). A biomechanical study found the plantaris tendon is stiffer and stronger~     than the Achilles tendon (AT), thus reducing its capacity to elongate in response to loading.~     This is hypothesized to result in friction between the AT and plantaris in some NIAT~     patients. Current treatment is conservative management: physiotherapy and high volume~     injection of the paratenon. However 29% of patients fail to respond to conservative~     management and those with plantaris related symptoms require its surgical excision and~     stripping of the ventral aspect of the AT through a 3cm medial incision. This is performed in~     theatres under general anaesthetic with good or excellent results reported in 90% of cases.~      Purely cutting the plantaris tendon using a minimally invasive endoscopic technique has also~     been successful. The plantaris tendon is easily visualized under ultrasound scan (USS) and~     tenotomy of tendons under USS guidance is performed elsewhere. Tenotomy of the plantaris~     tendon under USS guidance would necessitate a 5mm incision and may be performed under local~     anaesthetic as an out-patient. The current study thus plans a randomised clinical trial to~     compare outcomes (VISA-A scores and ultrasound tissue characterisation scans) from patients~     with NIAT undergoing plantaris release using an open surgical procedure with those undergoing~     a minimally invasive US guided procedure. The former is known to provide good clinical~     outcomes; however the latter could significantly reduce post-operative scarring, recovery~     times and costs. Findings will ensure ethical, quality and cost effective patient care.~   "
60483|NCT02775188|"~     The purpose of this study is to ascertain if home-based therapy with monitoring via~     telemedicine can overcome many barriers to compliance and improve rehabilitation following~     ACL reconstruction. Patients undergoing ACL Reconstruction will be followed for 6 weeks~     during their outpatient physical therapy treatment. Subjects will undergo weekly physical~     therapy or weekly physical therapy paired with InterACTION.~   "
60484|NCT02775175|"~     In this study the investigators will test the impact of a modified Ramadan Fasting regimen on~     health and well-being. The 2016 Ramadan is around summer solstice in Germany making it one of~     the most challenging fasting periods for participating Muslims. The modified Ramadan Fasting~     consists of educational components around fasting, and advice for nutritional modifications~     in order to support health and well-being during Ramadan, while the control group will~     continue to fast as usual. The investigators will measure not only body weight/fat but also~     include measures of psychological well-being, and spiritual practice, and serum markers for~     blood lipids, and blood sugar. With this trial the investigators aim to determine, whether~     such modifications around Ramadan will be beneficial for health and well-being.~   "
60485|NCT02775162|"~     A multicenter randomized controlled trial to compare the efficacy of ex-vivo normothermic~     machine profusion with static cold storage in human liver transplantation.~   "
60486|NCT02775149|"~     Not only caries but also exposure to acids can lead to loss of tooth structure. This~     acid-related tooth structure loss is defined as dental erosion.~      A relationship between dental erosion and occurence of reflux disease was shown in numerous~     studies. On the one hand, patients with dental erosions frequently show reflux disease. On~     the other hand, many - but not all - reflux patients show dental erosions. It is believed~     that certain salivary parameters might explain, why not all reflux patients alike are~     affected of dental erosions.~      The aim of this study is to analyze the relationship and the extent of occurrence of dental~     erosions and reflux symptoms, including investigation of certain salivary parameters.~   "
60487|NCT02775136|"~     HS-1000 device, a proprietary new non-invasive brain monitor, is expected to safely and~     accurately monitor physiological signs of the brain with minimal discomfort to patients,~     providing information about normal or abnormal brain-related conditions and providing~     decision-making support for physicians. Investigators hypothesis that the HS-1000 is capable~     of detecting and monitoring various neuropathologies, using the acoustic raw data derived~     from the noninvasive procedure.~   "
60488|NCT02775123|"~     Investigators are planning a single center pilot randomized controlled trial to assess the~     potential of a Cytoadsorbant filter (Cytosorb®, Germany) to remove cytokines from the blood~     during cardiac surgery.~      Investigators will screen all patients undergoing cardiac surgery and approach those deemed~     at risk of post surgical complications [≥ 1 among: age >75 years old, double valvular~     replacement, complex surgery with expected CPB time >100 min, redo cardiac surgery, pre-op~     chronic renal failure (plasma creatinine level >120 mcmol/l) or chronic heart failure (LVEF~     <35%)].~      Patients with end-stage renal disease (dialysis dependence), undergoing an emergency~     procedure or an off-pump procedure, those who decline informed consent as well as those~     enrolled in another conflicting study will be excluded.~      Eligible patients will be approached, consented and enrolled in the trial. Patients will then~     be randomized to either receive conventional CPB (control arm) or CPB plus Cytosorb~     (intervention arm). The target population is 30 patients (15 per arm).~      For this pilot study, investigators main outcome will be differences between the two arms in~     measurement of serum levels for IL-2, IL-6, IL-10 and TNF alpha at baseline~     (pre-operatively), on ICU admission, as well as 6 and 24 hrs post CPB.~      Secondary outcomes will be changes in coagulation factors serum levels, the need for~     vasopressors, inotropes, mechanical ventilation and renal replacement therapy, ICU and~     hospital length of stay as well as in-hospital mortality.~      Recruitment period should span from May 2016 to April 2017.~   "
60489|NCT02775110|"~     This study evaluates the discontinuation of natalizumab either immediately or tapered off in~     the treatment of multiple sclerosis. Half of the fifty (50) participants will discontinue~     natalizumab immediately and the other half will taper off the drug, having two additional~     infusions, one at six weeks- and one at eight weeks-post discontinuation.~   "
60490|NCT02775097|"~     Evaluate the accuracy of the RTVue-XR and iVue for measuring the total corneal thickness, the~     epithelial thickness, and the stromal thickness in normal subjects and patients with various~     corneal conditions.~   "
60491|NCT02775084|"~     The purpose of the study is to examine the effect of dietary n-3 polyunsaturated fatty acid~     supplementation on subjects' pan CD4+ T cell function, cognition, and muscle function. Half~     of the participants will receive fish oil, while the other half will receive a placebo (olive~     oil).~   "
60731|NCT02771951|"~     This randomized controlled trial tests the efficacy of a culturally and linguistically~     appropriate, evidence-based intervention to slow weight gain or promote weight loss among~     overweight 6-9 year old Mexican-American children.~   "
60492|NCT02775071|"~     This study will evaluate the relationship between psychopathology, disordered eating, and~     impulsivity (measured by clinical interview, self-report measures, and objective testing) on~     changes in weight and psychosocial status in the first two years after bariatric surgery.~     Participants will be 300 adults who plan to undergo bariatric surgery. Participants will~     complete four assessments over a two-year period, one at baseline (before surgery) and 6, 12,~     and 24 months after surgery. Each assessment will include computer tasks, surveys, clinical~     interview, urine test, waist circumference and height/weight measurement. The investigators~     will track how psychopathology, disordered eating, and impulsivity are related to changes in~     weight and psychosocial status following bariatric surgery.~   "
60493|NCT02775058|"~     The device under investigation is SYNERGOSS, a CE (European Community CE) marked device.~      Synergoss is a granulated bone graft intended for use in dental applications. It is composed~     of a ceramic composite of Hydroxihapatite and Tricalciumphosphate in granules, coated with a~     dedicated collagen coating (porcine origin), obtained by means of collagen crosslinking on~     the ceramic granule surface.~      The purpose of the study is to confirm the foreseen efficacy and tolerability of SYNERGOSS, a~     synthetic dental graft coated with collagen. For this observational study, we will enroll~     patients that already received a surgical intervention for sinus augmentation/ socket~     preservation by means of SYNERGOSS to maintain and regenerate bone before installation of~     endosseous titanium implants to support a fixed prosthesis. Patients will be enrolled just~     before they receive the surgery for the installation of endosseous titanium implants, about~     24 weeks after the first surgery for the implant of SYNERGOSS.~      The primary hypothesis is to demonstrate that SYNERGOSS consistently obtains the foreseen~     clinical benefit as declared in the Technical File.~      The secondary hypothesis is to demonstrate that SYNERGOSS side effects and risks match those~     declared in the Technical File.~      The study design is a~        -  National~        -  Monocentric~        -  Prospective: the participants are identified and then followed forward in time.~        -  Observational: participants that have recently received the grafting with SYNERGIES as~          part of normal and foreseen clinical procedures are enrolled in the study when they~          receive surgery for titanium implant placement and observed over time, with no~          substantial intervention other than the foreseen clinical treatment~   "
60494|NCT02775045|"~     The purpose of this study is to improve the overall management of patients with Eosinophil~     Esophagitis. Currently, the best way to monitor Eosinophil Esophagitis is repeating the~     endoscopy procedure. The investigators plan to identify a biomarker in the blood (a~     measurable substance) that tracks with disease activity and will reduce the need for~     follow-up endoscopies.~   "
60495|NCT02775032|"~     End-of-life care often fails in providing optimal patient-centred care and quality of life.~     Patients frequently suffer from inadequate control of pain, from a lack of communication~     about their illness and options for treatment, and from poor psychosocial and spiritual~     support. Advance care planning (ACP) can tackle these problems by providing patients with an~     opportunity to formulate their wishes and plan their future care, should they become~     incapable of participating in medical treatment decisions. Previous studies show that ACP~     improves concordance between patient's preferences and end-of-life care received and quality~     of care at the end-of-life. However, ACP is yet to be embedded in routine clinical practice~     and public consciousness. General practitioners (GPs) are in an ideal position to discuss ACP~     with their patients. By introducing ACP during a routine office visit, GPs can facilitate a~     structured discussion of the patient's wishes for end-of-life care. However, no ACP models~     have been systematically developed and tested in general practice. We developed a complex~     intervention to improve the initiation of ACP in general practice following the steps of an~     international guidance for development and evaluation of complex interventions. Before~     performing a full-scale intervention trial to study the effectiveness of this intervention on~     quality of care and quality of life, this model needs to be validated and tested in a pilot~     trial.~   "
60496|NCT02775019|"~     This study is designed to evaluate the impact of the regular consumption of probiotic~     Lactobacillus reuteri-containing lozenges over a period of 42 days on parameters of oral and~     general health in crew members of a naval ship at sea.~   "
60497|NCT02775006|"~     The objective of this study is to investigate the effect of docetaxel monotherapy and the~     combination of docetaxel intercalated erlotinib in patients with relapsed EGFR wild type, ALK~     negative non squamous cell carcinoma.~   "
60498|NCT02774993|"~     Pulmonary cavitation, a hallmark of tuberculosis (TB), is the site of high mycobacterial~     burden leading to disease transmission. The cause of tissue destruction leading to cavitation~     in TB is primarily due to the host inflammatory response. A matrix degrading phenotype~     develops in TB, in which the activity of host proteolytic enzymes, specifically matrix~     metalloproteinases (MMPs) is unopposed by their specific Tissue Inhibitors of~     Metalloproteinases (TIMPs), thus driving tissue destruction and cavitation in TB. This tissue~     destruction causes morbidity and mortality. MMP inhibition with doxycycline has shown to~     improve lung function in patients with chronic lung diseases but its use in TB is unclear.~      We hypothesise that the MMP inhibitor doxycycline will reduce tissue destruction in human~     pulmonary tuberculosis.~      Specific aims:~        -  To investigate the MMP and TIMP secretion and gene expression in M. tuberculosis (M.tb)~          - infected primary neutrophils and monocytes from healthy volunteers taking doxycycline.~        -  To investigate the intracellular signaling pathways modulated by doxycycline~        -  To investigate the effects doxycycline has on biological markers of tissue destruction~          in TB patients~        -  To assess the tolerability and side effects of doxycycline with concurrent standard TB~          therapy~   "
60499|NCT02774980|"~     Patients with depression are frequently treatment resistant. Clinical manifestations of~     depression are various, but cognitive dysfunctions are commonly present. Many factors are~     involved in treatment resistance. As no biological marker is available, clinical markers~     could be considered in predicting response to antidepressive treatment.~      The aim of this study is to investigate the relation between the cognitive changes and the~     remission of depressive symptoms in patients with recurrent depression (Stage 2 of Thase and~     Rush classification).~      To explore the dynamics of cognitive dimension associated to clinical and functional~     remission, the investigators will observe neurocognitive functioning before and after~     introducing a new antidepressive therapy.~   "
60500|NCT02774967|"~     The gold standard for the treatment of gingival recession, is the coronal repositioning of~     the flap associated with the subepithelial connective tissue graft. The acellular dermal~     matrix (ADM) has been used as a substitute a subepithelial connective tissue graft in~     periodontal plastic surgery and mucogengivais, and has achieved similar results. The use of~     ADM has the advantage of avoiding possible pre and postoperative complications, as well as~     overcome the limitations presented by autograft. The different surgical techniques used for~     root coverage seek predictability and success. For this, besides the type of incision~     placements flap and graft are of utmost importance because the healing benefit and outcome.~      The aim of this study is to compare two surgical techniques for root coverage and evaluate~     which one provides better cosmetic results and less morbidity . 20 adults , nonsmoking~     patients , showing multiple bilateral gingival recessions , class I or II Miller located in~     canine, first and second premolars are selected. Both techniques use the ADM as a graft.~     However , in one Quadrant partial flap will be held together with relaxing incisions through~     an incision intrasucular , ADM will be positioned 1 mm apical to the cementoenamel junction~     (CEJ) and the flap will be positioned 1 mm coronal CEJ. In the opposite quadrant a minimally~     invasive technique periosteal envelope above does not use relaxing incisions , preserves the~     buds will be held , as well as avoiding any scars, the graft will be used to ADM. The~     clinical parameters (probing depth, clinical attachment level, bleeding on probing index,~     height and width of the gingival retraction and height and thickness of keratinized gingiva)~     will be evaluated 2 weeks after the basic periodontal therapy and after 6 and 12 months to~     surgical procedures. In addition, measurements of photographic gingival recession with the~     aid of software will be performed.~   "
60501|NCT02774954|"~     The study will test the efficacy of a hour long, one-on-one, active listening counseling~     session (called Change the Cycle or CTC) aimed at reducing behaviors among active people who~     inject drugs (PWID) that research has found to facilitate uptake of injection drug use among~     non-injectors. The study will involve ~1,100 PWID who will be randomized to CTC or an equal~     attention control intervention on improving nutrition. Participants will be recruited in Los~     Angeles and San Francisco, California and followed up at 6 and 12 months to determine changes~     in direct and indirect facilitation of injection initiation among non-injectors.~   "
60502|NCT02774941|"~     The purpose of this study is to compare clinical outcomes related to the current practice of~     using a jet nebulizer (JN) with aerosol mask (AM) or mouthpiece (MP) versus a vibrating mesh~     nebulizer (VMN) with a valved-mask (VM) or MP in the treatment of acute moderate to severe~     asthma in Children's Medical Center Dallas Emergency Department (CMCED). The investigators~     hypothesize that using the combination of a VMN and VM or MP will result in fewer hospital~     admissions and decrease length of stay in CMCED when compared to the current practice of~     using a JN and AM or MP.~   "
60503|NCT02774928|"~     Development of pulmonary hypertension (PH) in chronic lung diseases has both functional and~     prognostic implications .~      PH in Lung diseases is usually mild to moderate with preserved cardiac output, and evolves~     slowly alongside the progression of lung disease and hypoxemia .~      However, a minority of patients develop severe PH with elevations in pulmonary artery~     pressure that have been described as ''out of proportion'' to the underlying disease .~      The aim of this study is to compare the characteristics and outcomes of consecutive patients~     with PH-due to lung diseases diagnosed at our specialist referral center over a 1-year~     period.~   "
60504|NCT02774915|"~     Investigators are interested to explore the clinical and pathological characteristics of~     breast cancer with pregnancy, maternal age at the time of diagnosis of breast cancer during~     pregnancy, median gestational age at diagnosis, the level of the tumor differentiation~     patients present with, during pregnancy, and the hormonal-receptor status. Investigators plan~     to collect prospective quality research databases that could provide further important~     information concerning this condition and serve in both short- and long-term sequelae in~     mother and fetus.~   "
60505|NCT02774902|"~     The purpose of this study is to evaluate the effect of multiple oral doses of clarithromycin~     on the pharmacokinetics of TAK-438 and its metabolites in healthy male adult participants~     following a single oral dose of TAK-438.~   "
60506|NCT02774889|"~     The overall purpose of this multi-phase study is to develop (Phase 1) and test potential~     effectiveness and feasibility of Keep On Stepping On (KOSO)/Stepping Online, an online falls~     prevention maintenance program for Stepping On (SO) graduates in a group randomized trial~     (Phase 2).~      This application refers to effectiveness component of Phase 2, which entails the randomized~     clinical trial. Phase 1 has been completed. The feasibility component of Phase 2 will entail~     process evaluation of the Stepping Online intervention group only.~   "
60507|NCT02774876|"~     Carbohydrates are the main determinant of post-meal glucose excursion. However, fat and~     protein have been shown to also impact the postprandial glucose control, adding to the~     complexity of meal insulin calculation. Few studies have looked at the effect of~     macronutrients other than carbohydrates on postprandial glucose excursions with the~     closed-loop strategy. The objective of this study is to test whether the single-hormone~     closed-loop strategy can achieve similar post-meal glucose control with meals with a fixed~     carbohydrate content, but high in protein and/or fat when compared to a meal with a fixed~     carbohydrate content only.~   "
60508|NCT02774863|"~     Emotional Neglect (NE) is a form of abuse to the child whose prevalence is high (WHO Europe).~     Experiencing NE, psycho-emotional development and brain child may be impacted generating~     psychic suffering signs may progress to severe developmental disorders. The recognition of~     suffering can prevent and treat these disorders.~      This research promotes a multi-professional device, centered on observation, collection of~     expression of the baby's psychic pain (≤ 2 years) living in vulnerable families. The~     investigators assume that this collection requires the crossing of looks of a child~     psychiatrist and a repeated observation at home by a trained nurse.~      The two devices described in these two groups are devices set up as part of the routine~     management of these patients. Usually, depending on the means of structures (human and~     financial), one of these devices may be preferred over another.~   "
60509|NCT02774850|"~     Treatment for pediatric acute myeloid leukemia (AML) involves intensive chemotherapy regimens~     that result in periods of profound neutropenia leaving patients susceptible to severe~     infectious complications. Infectious complications are the leading cause of treatment related~     mortality among AML patients, but there are little clinical data to inform whether management~     of neutropenia post AML chemotherapy should occur in an outpatient or inpatient setting. The~     primary objective of this study is to compare the clinical effectiveness of outpatient versus~     inpatient management of neutropenia in children with AML.~   "
60520|NCT02774707|"~     Human autologous serum is commonly used in the treatment of dry eye disease. However,~     different patients may have different effect with autologous serum treatment. We would like~     to find if different autologous serum had different component of cytokines in different~     etiologies of dry eye.~   "
60510|NCT02774837|"~     Chronic Hepatitis B is the most common cause of chronic viral liver disease worldwide~     afflicting 350 million persons, leading to significant morbidity and mortality due to liver~     disease and HCC in 20-40% of infected persons. With the advent of nucleoside analogues, this~     rescued patients with significant risk of disease progression, but in most circumstances,~     therapy was needed long term as HBsAg seroclearance was an uncommon occurrence, and stopping~     therapy was associated with relapse of disease and hepatitis B flares. The use of pegylated~     interferons showed increased HBeAg seroconversion and HBsAg seroclearance rates compared to~     nucleoside analogues , however combination nucleos(t)ide analogue therapy has been quite~     disappointing. However a recent showed that the combination of telbivudine and tenofovir in a~     response guided therapy design, had a remarkable 6% HBsAg seroclearance at week 52 in~     patients. Such results require further confirmation. There is currently an unmet need for the~     large number of patients on long term nucleoside analogue therapy who have not achieved HBeAg~     seroconversion or HBsAg seroclearance. Such patients are seeking alternatives to long term~     therapy hence an exploration of other therapeutic strategies is attractive. An additional~     benefit of telbivudine has been the surprising improvement in renal function and this study~     seeks to examine whether this can improve the renal impairment that may be seen with~     tenofovir. Our study proposes to examine if the combination of tenofovir and telbivudine can~     improve endpoints. Patients fulfilling inclusion and exclusion criteria will be randomized to~     tenofovir or tenofovir and telbivudine (1:1 ratio). The primary endpoint will be a qHBsAg~     reduction of >1log at week 96, which may predict future HBsAg seroclearance, which is also a~     secondary endpoint. An additional primary endpoint is increase in eGFR in the combination arm~     compared to the monotherapy arm. The study aims to enroll 146 patients randomized 1:1 ratio~     (73:73) patients. Multivariate analysis will be performed of baseline and on-treatment~     factors that predict the primary outcome.~   "
60511|NCT02774824|"~     This is a 9-months extension to the following study, protocol number: 003-03: A study to~     evaluate the use of SOMVC001 (GALA) vascular conduit preservation solution in patients~     undergoing coronary artery bypass grafting (GABG). Participation is allowed exclusively to~     participants enrolled in the main protocol SOMVC001 (GALA).~   "
60512|NCT02774811|"~     Multi-centre randomised controlled trial of selective laser trabeculoplasty compared with~     prostaglandin analogue therapy as primary treatment for high tension open angle glaucoma.~      Participating centres are:~      Institute of Ophthalmology, UCL, London, UK McCord Hospital, Durban, South Africa Innovation~     Eye Centre, Kisii, Kenya~   "
60513|NCT02774798|"~     Anal Acoustic Reflectometry (AAR) is a reliable and reproducible technique that has been~     studied in our department over the last 6 years. Sound waves pass into a balloon placed in~     the anal canal and are used to measure the cross-sectional area. By gradually increasing and~     decreasing the pressure in the balloon the investigators can measure the pressure at which~     the cross-sectional area starts to increase and decrease, and the anal canal starts to open~     and close. This assessment mimics the natural opening and closing of the anal canal and the~     effect of squeezing the muscles.~      Rectal intussusception occurs when the rectal wall telescopes into itself distally and is~     termed prolapse when it protrudes through the anal canal. Not all patients will require~     surgery and, for some, it can lead to debilitating symptoms of constipation, pain and faecal~     incontinence. Currently, the Oxford grading system through radiological testing is used for~     classifying severity of rectal intussusception and prolapse; however this does not give us~     sufficient information about the anal sphincter muscles.~      The gold standard investigation of the anal sphincter muscles has been manometry which~     measures anal canal pressure at rest and during squeeze. However, it has limitations. In~     previous studies AAR has shown promise in the assessment of faecal incontinence and, that~     unlike manometry, it has been able to distinguish between different types of incontinence.~     Thus far, it has not been studied in patients with rectal intussusception and it is hoped~     that AAR parameters may provide an indication of when rectal intussusception becomes overt~     rectal prolapse. This can inform the clinician to guide further management of a group of~     patients with a condition that can have significant impact on quality of life.~   "
60514|NCT02774785|"~     The new device we are looking at is called the MarginProbe. It is a disposable probe which~     measures the margins of tissue removed to check they are clear of cancer cells, during breast~     conservation surgery. After specimen radiology, allows the Surgeon to remove further tissue~     if necessary, during the same operation if any involved margins are identified. This~     minimises the need for further repeat operations.~      Previous studies carried out elsewhere in the world (USA and Israel) have identified that the~     probe reduces re-excision rate but there has never been a study in the UK.~      The trial involves randomly allocating patients once they are in theatre, to either the~     MarginProbe procedure after breast conserving surgery and radiology has been completed, or~     not.~   "
60515|NCT02774772|"~     The investigators will collect a range of physiological, behavioural and environmental data~     using current mHealth and home-monitoring systems, environmental databases and patient~     characteristics, to determine to what extent asthma control and the occurrence of asthma~     exacerbations can be predicted.~   "
60516|NCT02774759|"~     The goal of this research study is to learn if a home-based physical activity program is~     feasible and can help endometrial cancer survivors lose weight.~   "
60517|NCT02774746|"~     The objective of this study is to investigate the hypothesis that delivery at 35 0/7- 35 6/7~     weeks in stable patients with gastroschisis is superior to observation and expectant~     management with a goal of delivery at 38 0/7 - 38 6/7 weeks. To test this hypothesis, we will~     complete a randomized, prospective, multi-institutional trial across NAFTNet-affiliated~     institutions. Patients may be enrolled in the study any time prior to 33 weeks, but will be~     randomized at 33 weeks to delivery at 35 weeks or observation with a goal of 38 weeks. The~     primary composite outcome will include stillbirth, neonatal death prior to discharge,~     respiratory morbidity, and need for parenteral nutrition at 30 days.~   "
60518|NCT02774733|"~     Objective: The main target of this study was to research the correlation between the~     pulmonary function and the circulatory parameters of retrobulbar blood vessels in patients~     with type 2 diabetes (T2DM) without diabetic retinopathy (DR).~      Method: T2DM patients without DR were choose to research the correlation between the~     pulmonary function and the circulatory parameters of retrobulbar blood vessels. The primary~     endpoints were the pulmonary function parameters; The secondary endpoints were the HbA1c,~     FPG, 2hPG, WC, and BMI. The tertiary endpoints were the blood-fat; In addition, the~     retrobulbar circulation in the retrobulbar blood vessels were evaluated using color doppler~     imaging (CDI).~   "
60519|NCT02774720|"~     The study is a proof-of-concept, double-blinded randomized, parallel group trial to compare~     the effectiveness of centre-based and home-based physical activity in helping people with MCI~     and early dementia meet physical activity recommendations. The primary outcome is achievement~     of physical activity recommendations. Secondary outcomes include cost-effectiveness and~     improvements in health and function.~   "
60540|NCT02774447|"~     The aim of this study is to investigate if day-case closure of ileostomy is feasible and~     safe.~   "
60521|NCT02774694|"~     Interventional pain management for back and neck pain is widely used, but the indications and~     relative merits of these techniques rest subject to discussion. This study aims to identify~     prognostic criteria for patients who might specifically benefit from interventional pain~     management. Specifically, the nociceptive reflex threshold will be investigated, which is a~     measure of central sensibilisation and thus a potentially important prognostic factor.~   "
60522|NCT02774681|"~     The purpose of this study is to evaluate if the study drug palbociclib has anti-tumor~     activity against the breast cancer that has spread to the brain and also to determine the~     overall radiographic response rate in the CNS. Palbociclib is an anti-cancer medication that~     has been shown to stop cancer cells from growing. It has been approved in hormone positive~     breast cancer, along with other hormone therapies and has been found to be effective. The~     preclinical studies suggest that the drug may also have activity in other types of breast~     cancer, such as HER2 positive breast cancer. The purpose of this study is to see if the study~     drug is effective in patients with brain metastasis, who have HER2-positive breast cancer.~   "
60523|NCT02774668|"~     The present study is designed to examine the effect of changes in body weight and related~     parameters associated with a commercially-available, low-carbohydrate diet plan. A parameter~     proposed to be studied here is the impact of fructose restriction and weight loss on serum~     uric acid concentrations and arterial stiffness.~   "
60524|NCT02774655|"~     The purpose of this study is to test in overweight and inactive adults whether the new PAI~     eHealh APP leads to better adherence to a physical activity regimen than the wearable step~     counter App from the market leader FitBit, and to evaluate if improved adherence will be~     reflected in a better cardiovascular profile in this group.~   "
60525|NCT02774642|"~     This study aims to examine whether integrating insomnia and PTSD treatment will enhance~     sleep, PTSD, and quality of life outcomes. This is a randomized control trial comparing~     integrated evidence based CBT-I into PE (CBTI-PE) versus to a non-active sleep component plus~     PE (hygiene-PE) to optimize PTSD, sleep, and quality of life outcomes in 90 Veterans. Such~     benefits would further the VA's commitment to improving the mental health, recovery, and~     community reintegration of Veterans detailed in the 2014-2020 VHA Strategic Plan. Findings~     from the proposed study offer a unique opportunity to determine the malleability of~     mechanisms (e.g., Total sleep time, Sleep efficiency) that can improve recovery outcomes~     among this vulnerable population and to inform future treatment development and research.~     Improved PTSD, insomnia, and quality of life outcomes can decrease risk of chronic impairment~     and ultimately help affected Veterans live richer, more productive lives.~   "
60526|NCT02774629|"~     Local lyophylized food extracts are available useful in skin prick test and atopy patch test~     to confirm food allergy. However, the investigators want to know the duration that the~     investigators can keep the extracts for the usage in this purpose.~   "
60527|NCT02774616|"~     Post-Market Clinical Follow-up of the new Ilivia ICD Family and the new Plexa right~     ventricular lead to fulfill requirements by the notified body and to support regulatory~     approval outside of the CE region~   "
60528|NCT02774603|"~     The aim of this study is to define and evaluate the efficacy of Aquatic Locomotor Training~     (ALT) compared to overground Locomotor Training in improving ambulatory function and~     health-related quality of life. The investigators hypothesize, that Aquatic Locomotor~     Training is capable of producing outcomes that are as good as, or better than, overground~     Locomotor Training.~      Aquatic Locomotor Training may be another tool for therapists to utilize for clinical~     improvements in function and gait for the Spinal Cord Injury (SCI) population.~      To determine the efficacy of Aquatic Locomotor Training on improving rehabilitation outcomes~     among patients with incomplete traumatic cervical Spinal Cord Injury by assessing these~     parameters:~        1. Walking speed and endurance~        2. Functional balance and fall risk~        3. HRQoL~      To describe the feasibility of conducting Aquatic Locomotor Training as an Locomotor Training~     modality for the rehabilitation of patients with incomplete traumatic cervical Spinal Cord~     Injury.~   "
60529|NCT02774590|"~     This research is being done to determine the safety and tolerability of timolol in the~     treatment of acne and rosacea. The investigators will also look for specific biomolecular~     changes in acne or rosacea skin when it is exposed to timolol.~      Timolol is approved by the Food and Drug Administration (FDA) for the treatment of glaucoma.~     In dermatology, it has been used as a treatment to decrease the size of vascular (blood~     vessel) malformations in infant skin. Timolol is not approved for use in acne or rosacea and~     its use in this study is investigational.~      Many people with rosacea have telangiectasias which are small, red dilated blood vessels on~     the skin. They also suffer from flushing and acne-like lesions. Better treatments than those~     currently available are desired.~      Acne vulgaris, or acne, is another chronic inflammatory and very common skin disease that~     affects about 8 out of 10 young adults and adolescents. Signs of acne include papules and~     blackheads that are often called primary lesions because they represent an active form of the~     disease. There are also secondary lesions that can form later; they are known as acne scars~   "
60530|NCT02774577|"~     Noninvasive assessment of VO2 during a single session of whole body vibration and changes in~     blood flow caused by the acute activity.~   "
60531|NCT02774564|"~     The purpose of this study is to the effect of three single oral doses of nebicapone (50 mg,~     100 mg and 200 mg) on the levodopa pharmacokinetics when administered in combination with a~     single-dose of controlled release levodopa 200 mg/carbidopa 50 mg (Sinemet CR 200/50).~   "
60541|NCT02774434|"~     The Canadian Pediatric Society recently published guidelines to monitor bilirubin levels and~     as part of standard of care all hospitalized newborns are routinely monitored for the~     development of high bilirubin or jaundice every 8-12 hours. One device approved and used in~     both Canada and the United States is the Draeger Jaundice Meter JM-103, a non-invasive~     medical device. It has been proven to be effective in patients >35 weeks gestational age.~     Recently the JM-103 has been upgraded to include a bigger touch screen, greater storage and~     functionality. The rest of the features of the JM-103 and JM-105 are identical. In order to~     test the accuracy of the JM-105 neonates from ≥ 24 weeks gestational age who have or have not~     undergone phototherapy will be prospectively monitored for transcutaneous bilirubin (TcB)~     using the JM-105. The measurements will be compared to a physician-ordered total serum~     bilirubin (TSB).~   "
60532|NCT02774551|"~     This intervention study will be conducted on patients included in a nationwide and~     prospective cohort, The Oesophageal Surgery in Cancer patients: Adaptation and Recovery study~     (OSCAR). The OSCAR includes patients operated on for oesophageal cancer in Sweden between~     2013-2018, identified through pathology departments and included in the cohort 1 year after~     surgery. A comprehensive interview is conducted by a research nurse during a home visit using~     patient reported outcomes on several HRQOL, psychosocial, emotional and nutritional aspects.~     Regular follow-ups are carried out at 1½, 2, 2½, 3, 4 and 5 years postoperatively.~      All patients within OSCAR are invited to the intervention trial. Half of the eligible~     patients will be randomised to intervention and half to standard care (control group) by~     means of block randomisation method. The intervention group will be encouraged to adhere to a~     physical activity regimen of 150 minutes of weekly minimum intensity activities and 5 simple~     strength training exercises twice a week as instructed by the research nurse. The control~     group will follow their routine daily physical activity. HRQOL measures, height and weight,~     body composition, muscle strength, functional mobility and strength, and dietary intake are~     assessed before and after the intervention. Compliance will be ensured by means of a daily~     physical activity dairy and a weekly follow up on telephone with all patients.~   "
60533|NCT02774538|"~     Human papillomaviruses (HPVs) are the most common of sexually transmitted viral agents and~     they are associated with genital and oral diseases.~      Agreement between cervical and oral HPV infection has been described from a small group of~     patient. Our study, performed on a greater number of patients, will provide a good estimation~     of this link, between cervical and oral infection, in a French population of women with a~     primary cervical HPV infection.~   "
60534|NCT02774525|"~     The co-occurrence of child maltreatment and parental substance-use problems is a major public~     health problem with serious consequences for children, parents, families, and the community~     at large. The need for effective dual treatment of caregiver substance abuse and child~     maltreatment is unquestionable, but there is a dearth of controlled treatment outcome studies~     with substance-using parents who have engaged in child maltreatment. This project examines~     two evidence-based treatments—Contingency Management for substance-use problems and Pathways~     Triple P parenting intervention to improve parenting for prevention of child-maltreatment~     recurrence. These two systematic interventions are being tested in the context of traditional~     outpatient treatment for substance-use problems.~   "
60535|NCT02774512|"~     This is a monocentric prospective non randomized phase 0 clinical trial targeting patients~     with colon cancer for whom an upfront surgery has been advised by the pluridisciplinary team.~   "
60536|NCT02774499|"~     Oral medications like gabapentin and acetaminophen are commonly given to patients prior to~     surgery to provide balanced anaesthesia. Intravenous methadone has been shown to decrease~     postoperative pain as well as postoperative nausea and vomiting, which are known barriers to~     discharge. Oral methadone would be a convenient alternative to give as a preoperative~     medication with its bioavailability approaching 80%. No clinical trials to date have explored~     the utility of oral methadone as a preoperative analgesic to improve postoperative outcomes.~     Current literature shows preoperative IV methadone reduces opioid consumption in the~     perioperative period for cardiac surgeries; therefore, investigators hypothesize that~     preoperative oral methadone will also reduce postoperative pain and opioid consumption in~     patients undergoing sternotomy for cardiac surgery.~   "
60537|NCT02774486|"~     The primary cause of being overweight is an imbalance in calories consumed and energy~     expenditure. A surplus in energy intake might result in body fat deposition and thereby body~     weight gain. Therefore, food intake regulation is crucial to control the body weight gain.~      Appetite regulation plays an important role in determining the food intake, which is a~     complex process influenced by the individual (physiology and psychology) and environment.~     Satiation (process that leads to the termination of eating) and satiety (decline in hunger,~     increase in fullness after a meal has finished) are the precursors of appetite regulation,~     which may be induced by various food components such as macronutrients, water, alcohol and~     non-digestible polysaccharides. High viscosity and swellable/bulking food components such as~     dietary fibre are expected to elicit stronger satiation/satiety than the macronutrients or~     clear liquid. Due to its unique physicochemical properties, dietary fibre has been recognized~     as potential ingredient that helps to enhance the sensation of satiety in the upper gut by~     increasing gastric distension and delaying gastric emptying, which subsequently reduces the~     food intake.~      IQP-AK-102 comprises of a proprietary blend of dietary fibres known to promote a feeling a~     fullness. The objectives of this study are to evaluate the efficacy and safety of IQP-AK-102~     on appetite reduction in overweight subjects during a 4-weeks interval.~   "
60538|NCT02774473|"~     Patients with a history of metastatic breast cancer who are candidates for participation in~     the companion therapeutic trial, UPCC 06115 A Phase I Trial of Ribociclib (LEE011) and~     Weekly Paclitaxel in Patients with Rb+ Advanced Breast Cancer may be candidates for this~     imaging study. Patients may participate in this study if they are at least 18 years of age,~     most participants will be receiving care at the clinical practices of the University of~     Pennsylvania. Patients that meet the eligibility criteria will be approached about study~     participation regardless of race or ethnic background.~      The investigators anticipate enrolling up to 20 participants with metastatic breast cancer~     who meet eligibility requirements for this study and for the companion therapy trial UPCC~     06115 A Phase I Trial of Ribociclib (LEE011) and Weekly Paclitaxel in Patients with Rb+~     Advanced Breast Cancer, Accrual will likely occur over approximately 4 years.~      Positron emission tomography (PET/CT) imaging will be used to evaluate proliferative activity~     in sites of metastatic disease using the investigational radiotracer [18F]fluorothymidine~     (FLT). Imaging will occur prior to starting therapy on the separate therapeutic protocol UPCC~     06115. Patients may undergo a second FLT PET/CT scan following a 3-day run of ribociclib~     (LEE011) (day -6 to -4) on Day -3 (± 1 day) and a third FLT PET/CT scan on cycle 1 day 1 (-1~     day) before starting treatment with Paclitaxel to compare changes in FLT uptake measures.~   "
60539|NCT02774460|"~     The PHYSIC study aims to investigate the potential for precision medicine in the treatment of~     high blood pressure.~      It is a double-blind, randomized, repeated cross-over trial with six treatment periods: four~     classes of blood pressure-lowering drugs where treatment with two classes are repeated for~     each patient. The classes of blood pressure-lowering drugs to be tested are a diuretic, a~     calcium channel blocker, an ACE-inhibitor and an angiotensin receptor blocker.~   "
60542|NCT02774421|"~     This study plans to detect the presence of trastuzumab by mass spectroscopy in relapsed~     posterior fossa ependymoma (PFEPN) tumor specimen pre-treated with a single dose of~     intrathecal (IT) trastuzumab, as well as to evaluate toxicity of intrathecal trastuzumab in~     combination with subcutaneous (subQ) Granulocyte-macrophage colony-stimulating factor~     (GM-CSF) in children with relapsed PFEPN~   "
60543|NCT02774408|"~     In this 2-phase cross-over study the investigators test the hypothesis that automated~     adjustment of the inspired oxygen with the combined use of synchronized noninvasive~     SpO2-sensitive and apnea-sensitive backup-ventilation (S-NIPPV) increases the time within the~     intended oxygen saturation range as compared to automated FiO2 adjustment alone.~   "
60544|NCT02774395|"~     The endometrial cancers are among the most common malignancies in postmenopausal women with~     an incidence on the rise. It is most often a endometrioid adenocarcinoma (grade I, II, III).~     Other histological types are represented mainly by the clear cell carcinoma, papillary serous~     carcinoma, the carcinosarcoma. The main risk factors for endometrial cancer are age, obesity,~     diabetes, hypertension, hormone replacement therapy with estrogen and tamoxifen.~      Endometrial hyperplasia usually precedes endometrial cancer is classified by degree of~     cytologic atypia. Tumor grade quantifies the degree of differentiation and significantly~     influences the prognosis. Most research has been applied to define the role of estrogen in~     these cancers, however an accumulation of data indicate that the general process of~     tumorigenesis is closely related to immune and inflammatory microenvironment of the tumor. In~     fact, the microenvironment may be seen as a prognostic parameter of tumors or even predictive~     of therapeutic response.~      Recognized as the key molecules responsible for leukocyte recruitment into the tissues, the~     chemokine-receptor pairs are key players in the immune response, including the anti-tumor~     immune response but also the inflammatory response. The chemokine-receptor pairs are also~     involved in many other basic processes such as proliferation, survival or cell death.~      The objective of this study was to evaluate the prognostic value of the expression of the~     chemokine fractalkine (FKN) and its receptor CX3CR1 for the development of endometrioid~     adenocarcinomas.~      Chemokine FKN has the particularity to exist in two forms, a soluble (FKNs), like all~     chemokines and membrane form (FKNm). The FKNs, resulting from proteolytic cleavage of the~     FKNm, is provided with chémoattractantes properties. FKNm the present adhesion molecule~     properties.~      The role of FKN in cancer biology is complex.~      To date, the role of FKN in endometrial cancer has not been reported. Similarly, the precise~     role of FKN in the physiology of the endometrium is unknown.~      Nevertheless, fractalkine is one of the most expressed in endometrial chemokines. The~     expression of FKN and its CX3CR1 receptor is detected in the endometrium at all stages of the~     menstrual cycle. The respective levels of expression of each are fluctuating and largely~     dependent on the cycle of stage suggesting a possible control by estrogen and progesterone~     control described elsewhere ovarian level and endothelial. The cells of the endometrial~     glandular epithelium, macrophages, neutrophils and NK cells infiltrated in this tissue as~     well as the endothelial cells of blood vessels express FKN. Interestingly, all the cells~     mentioned above express CX3CR1, except for NK cells and unlike most tissues, the CD8 cells,~     present in the endometrium, do not express CX3CR1.~      In addition, the strongest expression of FKN and CX3CR1 cells by endometrial epithelial~     coincides with the maximum activity of the glandular epithelium suggesting a possible~     autocrine loop promoting cell proliferation of the endometrium. Concurrently with the peak of~     fractalkine, an accumulation of monocytes / macrophages and neutrophils is observed in the~     endometrium. It appears, moreover, that the balance between the soluble and membrane forms of~     FKN is important for positioning, infiltration and activity of immune cells within the~     endometrium.~      Current knowledge on the involvement of FKN / CX3CR1 axis in the physiology of the~     endometrium, although incomplete, point unequivocally the potential role of this ligand pair~     / receptor in the physiology of the tissue and also suggest that a malfunction of this axis~     could easily cause various diseases.~      Chronic inflammation of a tissue, largely dependent on macrophage infiltration rate,~     generally represents the tumor development. The endometrium is subjected to physiologically~     cyclic and regular inflammatory episodes, mirrors for the expression of chemokines and~     leukocyte infiltration. However, prolonged leukocyte infiltration establishing chronic or~     prolonged inflammation of the endometrium could help shape a favorable microenvironment in~     tumor development. Curiously, the axis FKN / CX3CR1 is involved in the development of several~     inflammatory diseases, including obesity and diabetes are also risk factors for endometrial~     cancer.~      A change in the expression of FKN and / or CX3CR1 is potentially capable of altering the~     inflammatory physiological cycle of the endometrium and therefore likely to be an element to~     consider in the evaluation of cancer risk factors of the endometrium.~      The assumption is that the FKN / CX3CR1 couple could intervene in the pathophysiology of~     endometrioid adenocarcinomas.~   "
60545|NCT02774382|"~     The purpose of the study is to investigate if treatment with fecal microbiota transplantation~     or rectal bacteriotherapy is superior to standard vancomycin in patients with recurrent~     Clostridium Difficile infections.~   "
60546|NCT02774369|"~     It has been suggested that the practice of physical exercise can improve sleep, but few~     studies have investigated this issue in the context of cancer, despite the proven benefits of~     exercise in this population. This randomized-controlled trial (RCT) aimed to compare the~     efficacy of an aerobic intervention program to that of a self-administered~     cognitive-behavioral therapy (CBT) to improve sleep of cancer patients. Forty-one men and~     women with insomnia symptoms and treated within 6 months for a non-metastatic cancer~     participated in the study.~   "
60547|NCT02774356|"~     This mentored student research project is funded by the Graduate Research Partnership Program~     with a projected timeline for data collection in the summer of 2015. Previous research has~     shown that language experience alters the way the human brain processes speech information.~     This phenomenon takes place very early in life and is referred to as Native Language Neural~     Commitment. For instance, as the Japanese language does not have the l-r speech sound~     contrast, Japanese infants start to show difficulty in hearing differences between the~     English l and r sounds at 12 months of age but not when they were at 6 months old. Learning~     the l-r distinction later in life proves to be very difficult for the Japanese school~     students and adults. Brain imaging studies have further revealed specific brain regions that~     are changed by language learning. But the evidence in support of the Native Language Neural~     Commitment theory is based on cortical-level measures. The proposed study extends the~     measurement to the subcortical level at the brainstem. The target language that the~     investigators are interested in studying is Mandarin Chinese, which is known for its use of~     lexical tones to express different words. For instance, the Chinese syllable ma means~     mother when it is spoken with a flat tone, and it means hemp when spoken with a rising~     tone. English, by contrast, does not employ lexical tones, and it is considered a non-tonal~     language. Does the Chinese learning experience fundamental change the way that pitch~     information is coded in the human brain? Does it happen at both cortical and subcortical~     levels? Previous research has shown evidence for a positive answer to both questions. But the~     direct evidence for brain-behavior correlations at the subcortical level is still missing.~      The proposed cross-language study will test Chinese-speaking and English-speaking adults to~     investigate Native Language Neural Commitment at the subcortical level. The investigators are~     interested in differences in the two subject populations by examining the relationship~     between brainstem pitch tracking and behavioral pitch perception in linguistic and~     nonlinguistic stimuli.~      The results of the proposed project will contribute to the understanding the role of the~     subcortical brainstem in Native Language Neural Commitment, which have significant~     implications for the development of auditory/speech training programs and assessment tools~     utilizing the brainstem frequency following measure to monitor progress in second language~     learning and test clinical populations.~   "
60548|NCT02774343|"~     The purpose of this research study is to determine whether a medication called pioglitazone~     (trade name Actos) can reduce behavioral problems associated with cocaine use, improve brain~     structural changes associated with cocaine use and reduce cocaine craving and drug use in~     cocaine dependent patients.~   "
60549|NCT02774330|"~     Improving healthy food availability and decreasing the availability of high calorie, low~     nutrient products, particularly in underserved communities, has been identified as a leading~     strategy for local governments to prevent obesity. However, policy action in this area to~     date has been limited. This R01 will examine the impact of a local policy change that~     establishes minimum stocking criteria for a wide array of healthy foods as a requirement of~     food store licensing. To our knowledge, this is the only policy of its kind in the US. As~     such, if it is successful, it could serve as an important model policy for other local~     governments seeking to increase healthy food availability and prevent obesity through local~     policy action.~   "
60550|NCT02774317|"~     With the advent of measures to try to decrease the incidence of transfusion-related acute~     lung injury (TRALI), the Blood Bank industry is attempting to avoid collection of plasma from~     female donors who have been pregnant in order to reduce the transfusion of plasma that may~     contain HLA antibodies. This has led to a decrease in the number of donors available for the~     production of fresh frozen plasma (FFP). Per Blood Bank regulatory standards in the United~     States, FFP must be frozen within 8 hours of collection. Plasma that is frozen within 24~     hours of collection is called FP24, and it is produced when whole blood cannot be processed~     within the 8-hour time period for the generation of FFP. Studies of coagulation factors in~     FFP and FP24 have shown that coagulation factor activities are adequate to maintain~     hemostasis in both products. Many hospitals are using FFP and FP24 interchangeably in adults,~     and occasional hospitals are using these products interchangeably in neonates. However,~     studies concerning the use of FP24 in neonates have not been performed.~      The investigators propose a single center prospective pilot study comparing the clinical~     efficacy of FFP vs. FP24 in 50 nonsurgical neonates and babies up to age 6 months requiring~     plasma for an International Normalization Ratio (INR) of 1.5 or more.~      This protocol describes a pilot study to compare the use of FFP with FP24 in nonsurgical~     neonates. Use of plasma in these cases is mostly for patients with perinatal hypoxia or~     necrotizing enterocolitis and an INR of 1.5 or more. Transfusion of plasma (10 to 15 ml/kg)~     is performed for these patients approximately every 8, 12, or 24 hours, as deemed indicated~     by the patient's clinicians, and monitored with prothrombin time (PT), partial thromboplastin~     time (PTT), and INR.~   "
60551|NCT02774304|"~     The goal of the study is to determine Eadyn as a functional measure of arterial load, in~     conjunction with other actual afterload indices, derived from both invasive arterial pressure~     tracing and non-invasive signals, such as arterial saturation, non-invasive cardiac output~     obtained by bio-reactance, and non-invasive stroke volume. A secondary aim is the correlation~     of the different non-invasive signals with the invasive arterial pressure tracing~     characteristics.~   "
60573|NCT02774018|"~     The present study attempted to test the benefits of a Mindfulness-Based Stress Reduction~     (MBSR) program in Portuguese institutionalized elderly people, as a way to improve life~     satisfaction and reduce psychopathology. The sample included 12 institutionalized elderly~     people, with ages between 65 and 91 (M = 82.58 years; SD = 7.87), that filled several~     selfreport questionnaires and were assessed with Mini Mental State Examination. Participants~     attended to an adapted Mindfulness-Based Stress Reduction program (KabatZinn,1994), with 48~     sessions (16 weeks) and Participants were evaluated before and after the intervention.~   "
60552|NCT02774291|"~     This pilot clinical trial studies the side effects of anti-ESO (cancer/test antigen) murine~     T-cell receptor (mTCR)-transduced autologous peripheral blood lymphocytes and combination~     chemotherapy with cyclophosphamide and fludarabine phosphate in treating patients with cancer~     that has spread to other places in the body (metastatic) and expresses the gene NY-ESO-1.~     Donor white blood cells that are treated in the laboratory with anti-cluster of~     differentiation (CD)3 may help treat metastatic cancer. Drugs used in chemotherapy, such as~     cyclophosphamide and fludarabine phosphate, work in different ways to stop the growth of~     cancer cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Giving more than one drug (combination chemotherapy) may kill more~     cancer cells. Aldesleukin may stimulate white blood cells, including natural killer cells, to~     kill metastatic cancer cells. Giving anti-ESO (cancer/test antigen) mTCR-transduced~     autologous peripheral blood lymphocytes together with combination chemotherapy and~     aldesleukin may kill more cancer cells.~   "
60553|NCT02774278|"~     This study will assess potentially predictive markers of efficacy in participants with NSCLC~     receiving oral erlotinib (Tarceva) therapy. The anticipated time on study treatment is until~     disease progression, unacceptable toxicity or death.~   "
60554|NCT02774265|"~     The purpose of this study is to perform a pragmatic randomized controlled trial to compare~     the use of low molecular weight heparin (LMWH, lovenox, enoxaparin) versus acetylsalicylic~     acid (ASA) for venous thromboembolism (VTE) prophylaxis in patients with high-risk lower~     extremity fractures.~   "
60555|NCT02774252|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
60556|NCT02774239|"~     This is a prospective open-label, uncontrolled, single-blind, pilot clinical trial.~      The primary objective is to assess the efficacy, safety, feasibility and tolerability of SCIG~     in patients with worsening MG.~      Participants with moderate worsening of MG symptoms (MGFA Class II and III) who are~     considered to be appropriate for immunoglobulin therapy will be screened for the study by the~     treating neurologist.~      Patients will be receive 2gm/kg (150gm for a 75kg patient) of 20% SCIG (Hizentra) infused~     over 4 weeks in a dose escalating manner.~      Additionally, this study will be assessing the feasibility of employing SCIG as an~     alternative therapy to IVIG in patients with MG exacerbation. The cost-effectiveness of SCIG~     versus IVIG will be evaluated, and the impact of SCIG therapy will be assessed from both a~     health-resource perspective and from a patient perspective.~   "
60557|NCT02774226|"~     Chronic obstructive pulmonary disease (COPD) affects up to 14 million people and is among the~     top five leading causes of death worldwide. Although COPD is a disease of the lungs, recent~     evidence indicates that COPD is associated with multiple systemic consequences including~     vascular endothelial dysfunction. Recently, it has been suggested that more patients with~     COPD die from cardiovascular disease and coronary heart disease than of direct pulmonary~     complications. Examination of the mechanisms that contribute to a reduction nitric oxide (NO)~     bioavailability resulting in vascular endothelial dysfunction in patients with COPD are~     important as endothelial dysfunction has been indicated to be an independent predictor of~     future atherosclerotic cardiovascular disease and events.~   "
60558|NCT02774213|"~     Up to 180 patients with bone metastasis and requiring analgesic treatment will be followed~     during 4 to 10 weeks. All patients will continue to receive their cancer therapeutic~     treatments and be treated for pain relief exactly as they would normally be by the~     Investigator based on their needs. During their regular visits to the Investigator, patients~     will complete questionnaires and Clinical Pain Assessments.~   "
60559|NCT02774200|"~     A one-arm exploratory clinical research program Study of Apatinib in Advanced Metastatic~     Renal Cell Carcinoma （mRCC） Patients.It`s arm to evaluate the treatment of advanced~     metastatic renal cell carcinoma in patients with objective response rate (ORR), disease~     control rate (DCR), progression-free survival (PFS), overall survival (OS), quality of life~     score (QoL) and safety.~   "
60560|NCT02774187|"~     The purpose of this study is to evaluate the efficacy and safety of sorafenib combined with~     hepatic arterial infusion chemotherapy (HAIC) compared with sorafenib Alone in patients with~     hepatocellular carcinoma (HCC) with major portal venous tumor thrombus (PVTT).~   "
60561|NCT02774174|"~     This study is a single centre, non-randomised, post market clinical follow up examining~     retrospective patient data from a series of surgical cases; which involved the endoprosthetic~     replacement of the proximal humerus using the Stanmore Implant Worldwide METS (Modular~     Endoprosthetic Tumour System) Proximal Humeral system.~      The objective of this study is to evaluate the retrospective patient data where patients have~     been followed up for at least 12 months post operation; to demonstrate the safety of the METS~     Proximal Humeral replacement system.~   "
60562|NCT02774161|"~     This pilot trial studies how well B-mode ultrasound imaging works in detecting liver cancer~     that is early in its growth and may not have spread to other parts of the body. Diagnostic~     procedures, such as B-mode ultrasound imaging, may help find and diagnose liver cancer and~     find out how far the disease has spread.~   "
60563|NCT02774148|"~     The primary objective is to determine if intravenous acetaminophen decreases pain scores and~     the amount of morphine equivalence received as compared to oral acetaminophen in patients~     greater than 65 years old after sustaining a hip fracture.~   "
60564|NCT02774135|"~     This study evaluates the improvement of participation in everyday occupation among preschool~     children with mild developmental disabilities as a result of Occupational Therapy~     intervention.~   "
60565|NCT02774122|"~     This study is to compare the effectiveness of CAABT and masking therapy in the management of~     subjective tinnitus in adults.Half of participants will receive CAABT, while the other half~     will receive masking therapy.~   "
60574|NCT02774005|"~     LEROS is an open-label interventional Phase IV study, designed to further assess the efficacy~     and safety of Raxone® in the long-term treatment of LHON patients.~   "
60582|NCT02773901|"~     In current practice patients with a suspected increase of intracranial pressure (ICP) will~     undergo a lumbar puncture with measurement of cerebral spinal fluid (CSF) pressure (as a~     marker for ICP). A lumbar puncture is an invasive and sometimes painful procedure. Using a~     new type of ICP monitor (HeadSense) it is possible to measure ICP non-invasively through an~     acoustic signal~   "
60753|NCT02771665|"~     To evaluate the influence of mammographic breast density at diagnosis on the risk of cancer~     recurrence and survival outcome in patients with invasive breast cancer after surgery~   "
60566|NCT02774109|"~     Purpose:~      To investigate the effects of fish oil on patients with chronic nonspecific low back pain.~      Material and Methods Subjects: 52 participants will be recruited from outpatient department~     of physical medicine and rehabilitation department and by poster.~      Duration: 2016.04.21-2017.03.31~      Methods: The participants will be randomly divided into the experimental group and the~     control group through the draw, with 26 patients in each group. Participants in the~     experimental group receive fish oil plus physical modality treatment. Participants in the~     control group receive placebo plus physical modality treatment.~      Assessment: Before the therapy starts, patients who match the inclusion criteria will be~     evaluated using tools mentioned below:~      General data: age, sex, body height, body weight, occupation, exercise habit~      Rate current, best and worst pain intensity of low back pain during the previous week with~     100mm Visual Analogue Scale (VAS)~      Measure pressure pain threshold with pressure algometer~      Measure lumbar spine range of motion in flexion and extension with tape measure~      Assess endurance of back extensor muscles with Biering-Sorenson test~      Classify the pain origin (nociceptive or neuropathic) with Chinese version of the~     identification pain (ID pain) questionnaire~      Assess the impact of low back pain to daily life with Chinese version of The Roland Morris~     Low Back Pain and Disability Questionnaire (RMQ)~      Assess the impact of low back pain to work performance and fatigue with Chinese version of~     The Health and Work Performance Questionnaire (HPQ) and the Occupational Burnout Inventory~      Assess the impact of low back pain to sleep quality with Chinese version of the Athens~     Insomnia Scale~      Draw 10ml blood for blood test (ESR and hs-CRP)~      Participants will be followed up 4 weeks and 8 weeks after therapy starts and re-assessed of~     pain intensity, pressure pain threshold, lumbar spine range of motion, back extensor muscles~     endurance, and the impact of low back pain to daily life, work, and sleep quality. Blood test~     will be committed again after therapy course finished.~   "
60567|NCT02774096|"~     With more and more people developing hypertension and atherosclerosis, the morbidity rate of~     Acute Aortic Dissection（AAD） has been increasing. Emergency surgery is the main treatment for~     Acute Aortic Dissection. However the secondary injury caused by reperfusion of spinal cord~     could lead to Catastrophic complications,such as paraplegia, hemiplegia or even death. So~     spinal protection is always the hot topic in clinical research.~      Xenon is an ideal anesthetic gases with the following features,fast onset of action, stable~     hemodynamics, clean and non-toxic.The animal researches have showed the protective effects of~     xenon to alleviate the ischemia-reperfusion injury of the nervous system.Those clues suggest~     that Xenon may have the potential protection of spinal cord in patients undergoing aortic~     dissection repair.In order to clarify this hypothesis, the investigators designed this~     randomized, controlled clinic trial to evaluate the protection of Xenon against spinal cord~     ischemia-reperfusion injury and the potential mechanisms~   "
60568|NCT02774083|"~     Background: The Feuerstein Instrumental Enrichment Program was designed to prevent mental~     deterioration and preserve cognitive abilities among people aged 60 and above. The program is~     an applied practicable program based on the theories of Structural Cognitive Modifiability as~     well as on a Mediated Learning Experience. The program takes into consideration the unique~     characteristics and requirements of the older population. The program is composed of a~     variety of cognitive tasks that offer systematic activities intended to stimulate mental and~     cognitive development.~      Objective: To examine the influence of the Feuerstein Program on the cognitive function and~     well-being of participants suffering from Mild Cognitive Impairment (MCI).~      Hypothesis: The Feuerstein Program will improve cognitive abilities and functional well-being~     of the participants.~      Methods: Residents of retirement homes will be offered to participate in the research.~     Participants will undergo cognitive and functional assessments that will be carried out on~     four specific dates. The participants of the Intervention Group will participate in the~     Feuerstein program using a method of mediated learning while the Control Group will~     participate in a program of the Adler Institute involving activities aimed at social and~     emotional development without specific cognitive skill training.~   "
60569|NCT02774070|"~     This study detects the presence of atlantoaxial joint affection in symptomatic versus~     asymptomatic rheumatoid arthritis patients revealed by plain X-ray and magnetic resonance~     imaging of the cervical spine~   "
60570|NCT02774057|"~     Ulcerative colitis (UC) is an inflammatory bowel disease (IBD) characterized by chronic~     inflammation limited to the mucosal layer of the colon. Anemia is a consistent clinical~     feature of IBD. It is encountered in one third of IBD patients, and is the most common~     extraintestinal complication of this disease. Anemia has a significant impact on the quality~     of life of affected patients. Many patients with IBD frequently complain of chronic fatigue~     commonly caused by anemia and this may be as debilitating to patients as abdominal pain and~     diarrhea. Anemia in IBD is multifactorial, but is most commonly the result of iron deficiency~     anemia (IDA) and rarely due to anemia of chronic disease (ACD). Oral iron supplementation has~     been used traditionally for the treatment of IDA but studies have shown that it may result in~     disease exacerbation by increasing oxygen free radicals within the lumen of the gut via the~     Fenton reaction. A recent study done in University Hospitals Birmingham, United Kingdom, has~     shown that treatment with oral iron results in failure to control anemia in 2 out of 3 IBD~     patients, which is in part due to the side effects reported by over half of patients.~     Captafer is a new iron-free oral preparation that contains a special type of oligosaccharides~     from fish muscle tissue able to make the intestine absorb 3 to 5 times more iron in~     comparison to the meat factor. Moreover, Captafer contains other vitamins and supplements~     that improve anemia.~   "
60571|NCT02774044|"~     The purpose of the study is to evaluate the efficacy and safety of Cadisurf (goat lung~     surfactant extract) as compared to Survanta (beractant) in the treatment of respiratory~     distress syndrome in preterm neonates (with gestation of 26 to 32 weeks).~   "
60572|NCT02774031|"~     Low flow anesthesia (LFA) is used less than desirable, partly because one has considered that~     there might be danger of underdosing of anesthesia gas and thus risk of awareness under~     anesthesia.LFA has several advantages such as reducing loss of moisture and heat in the~     inhaled air under anesthesia and to reduce the consumption of anesthetic gas. A few~     anesthesia machines include an automatic gas control system: the Aisys machine, by GE~     Healthcare (Madison, WI, USA), and the Flow-i machine, by Maquet (Sweden).~      Since these machines were introduced, only a few studies have reported their functionality~     and effect on gas consumption. 20 to 55% reduction of gas consumption was found. The~     potential reduction may have been underestimated because in the majority of cases a FGF~     higher than 1 l/min was still used.~      In this study the consumption of anesthetic gas (desflurane) delivered by two different~     anesthesia machines (Aisys and Flow-i) will be compared, with and without gas control~     delivery systems. Gas consumption and the time needed to reach the target level of anesthetic~     gas concentration will be assessed. Data needed will be collected directly from the~     anesthesia machine, PICIS ( Electronic anesthesia record) and EPJ (Electronic patient~     journal). The results of this study are of interest for intraoperative ventilation and of~     economic and ecological interest~   "
60783|NCT02771275|"~     The primary objective of this study is to evaluate the safety and performance of the Harpoon~     Medical device in patients with degenerative Mitral Regurgitation~   "
60575|NCT02773992|"~     Medical The Internet of Things (IoT), a recent breakthrough in communication technology,~     could be helpful in improving health care delivery and saving medical costs, but regarding~     pulmonary nodule management it is still at the basic understanding. Investigators adopt~     Internet of things medical three plus two type pulmonary nodule diagnosis which chun-xue~     Bai put forward, used a developed a mobile phone-based IoT (mIoT) platform and initiated a~     randomized, multicenter, controlled trial to value clinical effectivity of Internet of~     things medical three plus two type pulmonary nodule diagnosis in the management of pulmonary~     nodules. In this study, at least 600 patients with pulmonary nodules (no typical symptoms,~     often single, clear boundary, increased density, soft tissue shadow surrounded by lung~     parenchyma with diameter ≤3 cm) will be randomly allocated to the control group, which~     receives routine follow-up, or the intervention group, which receives Internet of things~     medical three plus two type pulmonary nodule diagnosis management. Endpoints of the study~     include: (1) The positive diagnosis rate of lung cancer in I stage; (2) 5 year disease-free~     survival rate and overall survival rate; (3) direct medical costs per year. Results from this~     study should provide direct evidence for the suitability of Internet of things medical three~     plus two type pulmonary nodule diagnosis in pulmonary nodules patients management.~   "
60576|NCT02773979|"~     This phase I trial of the replication-intact PfSPZ Challenge vaccine given under CQ cover~     will enroll 28 healthy volunteers to receive PfSPZ or placebo, as well as suppressive doses~     of chloroquine (CQ)on varying schedules. 10 weeks post 3rd immunization subjects will be~     subjected to controlled human malarial infection. The primary objective of this study is to~     evaluate the safety and tolerability of escalating doses of Sanaria PfSPZ Challenge~     administered by DVI on varying schedules to healthy malaria-naïve adults taking suppressive~     doses of CQ (PfSPZ-CVac).~   "
60577|NCT02773966|"~     The objective of this randomized phase III study is to test the superiority of Kypho-IORT~     compared to EBRT with regard of time to pain reduction in patients with painful vertebral~     metastases. Therefore patients will receive intraoperative radiotherapy (8 Gy with Intrabeam~     System/Carl Zeiss) during kyphoplasty (Arm A) or external beam radiotherapy with 30 Gy, added~     in 3 Gy per fraction on a conventional linear accelerator or 8 Gy single dose (only for~     international study centers, not permitted in Germany) (Arm B).~   "
60578|NCT02773953|"~     Improvement in CPAP adherence can be obtained by usingTelemonitoring. T4P® is a~     telemonitoring unit added on CPAP device allowing to obtain a daily report of usage duration,~     mask leaks, pressure and apnea-hypopnea index. The purpose of this study is to assess the~     impact of telemonitoring on the delay to the first technical intervention after CPAP~     titration night in CPAP-treated obstructive sleep apnea patients managed in the sleep unit.~     The shortening of this delay could help to improve adherence during the first weeks of~     treatment. As a secondary aim, the investigators would like to assess the impact of~     telemonitoring on mean adherence during the first 3 months of treatment, which is a crucial~     period.~   "
60579|NCT02773940|"~     The purpose of the study is to collect information on prostate tissue biopsies collected with~     the ClariCore System during a radical prostatectomy procedure. The ClariCore System is~     designed to improve how biopsies are taken from the prostate by using light sensors (fiber~     optics) that can see changes in the tissue. The information collected from the study will be~     used to develop a method to tell the difference between normal and suspicious tissue to help~     guide the physician during a biopsy procedure.~   "
60580|NCT02773927|"~     Presence of metabolic syndrome (MetS) and its relation with insulin resistance, obesity,~     dyslipidemia, systemic inflammation and cardiovascular disease is of great concern. The study~     of certain adipokines such as adiponectin has demonstrated an inverse association with~     insulin resistance, especially in Latin population lower levels of adiponectin have been~     observed compared to other ethnic groups. It appears to be an important molecule that is~     involved in limiting the pathogenesis of obesity-linked disorders and may have potential~     benefits as a marker to evaluate the effect of possible interventions on the MetS components~     and its complications.~      Metformin is treatment of choice in patients with MetS, due to its low cost and~     pharmacological comparable effects with thiazolidinediones (pioglitazone), it decreases~     hyperinsulinemia, insulin resistance, free fatty acids and triglycerides, it produces as~     well, a moderate weight loss, improves lipid profile and delays the appearance of diabetes~     mellitus in subjects with an abnormal fasting glucose.~      A second choice to lower the risks would be the addition of a fiber like inulin, a prebiotic,~     since it has demonstrated metabolic benefits on lipid and carbohydrates metabolism by several~     mechanisms proposed such as induction of lipogenic enzymes by glucose, production of~     short-chained fatty acids, glucose-dependent insulinotropic peptide (GIP) and glucagon-like~     peptide-1 (GLP-1), and growth of Bifidobacterium. A good natural source of inulin is the~     agave.~      It is expected that the combination of metformin plus agave inulin will produce a beneficial~     impact through pharmacological synergism and that will produce changes in the pathophysiology~     of MetS.~   "
60581|NCT02773914|"~     The present study Comprehensive Geriatric Assessment for frail older people in Swedish acute~     care settings - a randomized controlled study comprises two study arms: one intervention and~     one control group. It is a multicentre trial with 5 centres with diverse local conditions in~     different parts of Sweden, with an implementation study alongside.~      The intervention Comprehensive Geriatric Assessment (CGA) for frail older people addresses~     people 75 years and older who are seeking acute hospital care at the hospital emergency~     department, and who are identified as frail. The CGA intervention, including a~     multidisciplinary team that assesses the patients socio-demographic background, social~     network, health and medical history, medications, functional status, cognitive status,~     nutritional status, somatic status and psychosocial status including depression, as well as~     treatment and planning for discharge and follow-up, contributes to a person-centred, and a~     comprehensive assessment tailored for each person. The results of this study are expected to~     optimize the implementation of future complex interventions and lead to the improvement of~     the care, support and rehabilitation for frail older people with complex needs.~      This study will contribute to an evidence base for full scale implementation of CGA in~     Swedish hospital care. The process evaluation, aiming to provide insight into function and~     consequences of the intervention, why it works or fails, is an important part of the design~     that will contribute with insights into real life conditions that may be challenging in~     implementing CGA. The investigators will evaluate fidelity and quality of the implementation,~     clarify causal mechanisms and identify contextual factors associated with variation in~     outcomes. The development of screening for frailty and CGA are potential and important tools~     to identify needs of this older population, and to direct the right health care actions~     towards those in most need.~      The study will address the following research questions:~        1. Can Comprehensive Geriatric Assessment for frail older patients in Swedish acute~          hospital settings:~             -  increase/maintain independence, functional status, health related quality of life~               and life satisfaction?~             -  increase satisfaction with health care?~             -  reduce health care consumption?~        2. How feasible and acceptable are the study processes and procedures of CGA from the~          perspective of care givers and older persons in Swedish settings?~   "
60935|NCT02769286|"~     Treatment efficacy of osimertinib will be assessed in patients with lung cancer harboring~     activating epidermal growth factor receptor (EGFR) mutations (cohort 1) and those harboring~     T790M (cohort 2) which were detected from circulating tumor DNA~   "
60583|NCT02773888|"~     Invasive intracranial pressure (ICP) monitoring is highly effective, but involves risks.~     HS-1000 measures ICP non-invasively by assessing the acoustic properties of the patient's~     head.~      HS-1000 device, a proprietary non-invasive ICP monitor, is expected to safely and accurately~     monitor ICP with minimal discomfort to patients, and provide information about normal or~     elevated ICP levels to the physicians.~   "
60584|NCT02773875|"~     This is a randomized crossover study testing the efficacy of the Fault Detection algorithms~     using the Zone MPC algorithm and DiAs artificial pancreas platform in adult patients with~     type 1 diabetes. The trial will last for 6 weeks for each individual subject, with three~     weeks using the AP algorithm and three weeks using sensor augmented pump in a randomized~     order~   "
60585|NCT02773862|"~     Patients with severe traumatic brain injury (TBI) are admitted to the intensive care unit~     (ICU). Under certain condition (such as a impaired consciousness) the intracranial pressure~     (ICP) is measured. An increase in the intracranial pressure might suggest secondary~     neurological deterioration and is considered an alarming symptom. Current practice is to~     insert an invasive monitor through a burr hole in the skull with the risk of bleeding and~     infection. Using a new type of ICP monitor (HeadSense) it is possible to measure ICP~     non-invasively through an acoustic signal.~   "
60586|NCT02773849|"~     Previous multi-dose Phase I and Phase II clinical studies have demonstrated that INSTILADRIN~     (nadofaragene firadenovec) is a safe and effective treatment for BCG-refractory and recurrent~     NMIBC. This Phase III study is designed to expand those observations using a high dose of~     INSTILADRIN in patients that are BCG Unresponsive which refers to patients with high-grade~     NMIBC who are unlikely to benefit from and should not receive further intravesical BCG.~   "
60587|NCT02773836|"~     The main objective of EUREST-PLUS is to monitor and evaluate the impact of the Tobacco~     Products Directive (TPD) within the context of FCTC ratification at an EU level. The~     investigators specific objectives, within WorkPackage 2 and Workpackage 3 are: To evaluate~     the psychosocial and behavioral impact of TPD implementation and FCTC implementation, through~     the creation of a cohort study of adult smokers in 6 European Member States (EU MS), Germany,~     Greece, Hungary, Poland, Romania, Spain; (total n=6000) in a pre- vs. post-TPD study design.~      EUREST-PLUS is funded through the European Union's Horizon 2020 research and innovation~     programme under grant agreement No 681109~   "
60588|NCT02773823|"~     The aim of this study is to evaluate the effects of comprehensive behavior on cardiovascular~     health among obese schoolchildren. The intervention methods include dietary instruction and~     exercise intervention. The main outcomes are weight, body mass index, blood pressure, lipids~     and glucose.~   "
60589|NCT02773810|"~     Currently there are approximately 400 women of reproductive age enrolled in outpatient~     monitoring of warfarin therapy through AMS. The investigators do not have any data on the~     percentage of women who are using family planning, but anecdotally the providers report that~     it is very low. The investigators believe that an educational intervention with an emphasis~     on the safest and most effective methods, long-acting reversible contraception (LARC), aimed~     specifically toward women with medical conditions requiring anticoagulation, combined with~     on-site provision of LARC can improve uptake of these methods. Ultimately, the use of the~     most effective methods of contraception will prevent unplanned pregnancy and the unnecessary~     maternal morbidity and mortality associated with high-risk pregnancies in women with these~     conditions.~   "
60590|NCT02773797|"~     A variety of medications have been used to treat the anxiety, discomfort, and fear associated~     with continuous and sudden episodic breathlessness in patients with advanced respiratory~     disease. Opioids and benzodiazepines, used alone or in combination, are commonly prescribed~     for this distressing symptom. Clinicians are concerned about the adverse effects of opioids,~     especially respiratory depression, so they frequently prescribe benzodiazepines. Recent~     studies have shown that benzodiazepine use is associated with adverse respiratory outcomes in~     older adults with Chronic Obstructive Pulmonary Disease (COPD). Dexmedetomidine may be an~     alternative to current drug therapies for breathlessness. Dexmedetomidine produces a dose~     dependent sedation, anxiolysis, and analgesia without respiratory depression or cognitive~     dysfunction.~      The drug can be administered intranasally (IN-DEX) to induce light to moderate sedation of~     several hours duration.~      The objective of the research is to assess the dose dependent safety and efficacy of~     intranasal dexmedetomidine compared to intranasal saline (placebo) in clinically stable~     patients with severe COPD. This will be accomplished in a staffed acute care setting with~     routine vital signs monitoring and continuous pulse oximetry. Patients will be assessed~     objectively and subjectively for their level of sedation by validated sedation scales.~      The study is an extension of a similarly designed pilot study which did not include a placebo~     comparison. Results of the study will be helpful to design additional trials with intranasal~     dexmedetomidine in acutely symptomatic COPD patients, exertional dyspnea and exercise~     performance, and dyspnea treatment comparisons.~   "
60591|NCT02773784|"~     -  This is a prospective, single-center, non-randomized, non-controlled study.~        -  The estrogen receptor (ER), progesterone receptor (PgR), HER2 status and Ki67 index of~          CNB specimen are critical biomarkers for making neoadjuvant therapy strategy in invasive~          breast cancer. The concordance of these biomarkers between CNB and surgical specimen was~          varied in previous retrospective reports. The aim of this study is to determine the~          discordance of these biomarkers between CNB and surgical specimen and the influence of~          making treatment strategy by the discordance.~   "
60601|NCT02773654|"~     The purpose of this study is to determine the ability of a mobile clinical application to~     reliably and accurately track scapular motion in people with asymptomatic and symptomatic~     shoulders. The ability to accurately and reliably measure shoulder position clinically is an~     important first step in choosing the best treatment techniques to treat shoulder movement~     dysfunction. Therefore, the primary objectives of the study are:~        1. To determine the inter- and intra-rater reliability of shoulder joint position~          measurements in symptomatic and asymptomatic subjects, by using a mobile application,~          with and without use of a handle for a smartphone~        2. To determine the validity of the shoulder joint position measurements measurements as~          described above.~   "
60689|NCT02772510|"~     The purpose of the present study was to investigate the effects of game-based virtual reality~     rehabilitation combined with functional electrical stimulation on distal upper extremity~     function, and compare the findings to those of functional electrical stimulation in stroke~     survivors.~   "
60592|NCT02773771|"~     Acute muscle wasting occurs early and rapidly during the first week of critical illness and~     contributes substantially to weakness acquired in the ICU. Muscle wasting and subsequent~     weakness is associated with delayed liberation from mechanical ventilation, prolonged~     hospital length of stay, long-term functional disability, and worse quality of life.~     Moreover, low muscle volume as well as ICU-acquired weakness increases the risk of mortality~     in critically ill patients. Although several factors likely accelerate skeletal muscle~     wasting during critical illness (e.g., immobility, inflammation, multi-organ failure), the~     understanding of the underlying mechanisms remains limited and is reflected in the lack of~     effective interventions to prevent the loss of muscle mass in ICU patients. To-date, there is~     no known safe and effective pharmacological or nutritional intervention to attenuate the~     acute loss of muscle mass in ICU patients.~      Leucine is an amino acid widely regarded for its anabolic effects on muscle metabolism.~     However, the concentrations required to maximize its anti-proteolytic effects are far greater~     than the concentrations required to maximally stimulate protein synthesis. This has resulted~     in the search for leucine metabolites that may also be potent mediators of anabolic processes~     in skeletal muscle; one such compound is β-hydroxy-β-methylbutyrate (HMB). HMB is thought to~     primarily facilitate protein synthesis through stimulation of mammalian target of rapamycin~     (mTOR), a protein kinase responsive to mechanical, hormonal, and nutritional stimuli that~     plays a central role in the control of cell growth. Randomized, controlled trials to assess~     the effect of HMB supplementation on clinical outcomes in patients with chronic diseases are~     limited, and even fewer studies have assessed its effects on skeletal muscle metabolism~     during critical illness. Furthermore, despite compelling preclinical evidence, the exact~     mechanisms underlying the effect of HMB supplementation during acute catabolic stress in~     humans is not well defined. Therefore, the investigators goal is to study the impact of early~     HMB supplementation on skeletal muscle mass in ICU patients and to explore the mechanisms by~     which HMB may exert its effects on skeletal muscle metabolism during critical illness.~   "
60593|NCT02773758|"~     This will be a single centre, two week, randomised, examiner blind, two treatment arm,~     parallel design, stratified (by maximum baseline Schiff sensitivity score of the two selected~     test teeth), controlled study, in participant with at least two sensitive teeth that meet the~     study criteria at the Screening and Baseline visits. The study will be conducted in~     participants in good general health, with pre-existing self-reported and clinically diagnosed~     tooth sensitivity at screening.~   "
60594|NCT02773745|"~     With aging population, total knee arthroplasty is performed with increasing frequency.~     Although the surgery is successful in general, significant number of patients suffers~     persistent pain and disability. Traditional risk assessment tool have been focused on single~     organ systems. Our investigators have found that mobility, assessed by the Mobility~     Assessment Tool short form (MAT-sf), is a simple and accurate method to predict postoperative~     outcome, including length of stay, postoperative complications, and nursing home placement~     for older patients. Prehabilitation is the process of enhancing a person's functional~     capacity to withstand an incoming stressor. Although multiple studies have tested~     prehabilitation before joint replacement surgery, results have been mixed. The investigators~     hypothesize that patients with limited mobility are most likely to benefit from~     prehabilitation. The investigators plan to use individualized aquatic exercise as a~     prehabilitation tool to enhance compliance; the resistance of water strengthen muscle and~     increasing energy expenditure; the buoyancy of water provides environment where the joints~     are not weight bearing. The aims of the study are: 1) To evaluate the feasibility of~     prehabilitation using 6-8 weeks of aquatic exercise in 40 geriatric patients who are~     scheduled for total knee arthroplasty for osteoarthritis; 2) To examine the effects of 6-8~     weeks of aquatic exercise on mobility, pain, stiffness, physical function, cognitive function~     and depression; inflammatory markers and 3) To estimate the effect of prehabilitation on~     postoperative outcomes. The investigators plan to enroll 40 patients age >50, who are~     scheduled for elective primary total knee replacement. Investigators will screen patients in~     the Preoperative Assessment Clinic and enroll patients who have decreased mobility, measured~     by MAT-sf. Patients will be randomized into either a prehabilitation group or a usual care~     group. All the participants will undergo extensive assessment on their pain, stiffness, and~     physical function, depression, balance and cognitive function using the Western Ontario and~     McMaster Universities Osteoarthritis Index (WOMAC), the expanded Short Physical Performance~     Battery (eSPPB), and Montreal Cognitive Assessment (MoCA). Serum inflammatory markers will be~     assessed at the baseline. The prehabilitation group will undergo 6-8 weeks of individualized~     aquatic exercise in a heated pool (60 min/session, 3 times per week). Aquatic equipment maybe~     used to challenge balance and trunk stabilization. All participants will be reassessed~     immediately before surgery and 4 weeks after the surgery using WOMAC, eSPPB, MoCA and MAT-sf.~     Serum inflammatory markers and body composition will be reassessed at the same time points.~     The primary outcome of interest is will be postoperative complications, length of stay,~     Intensive Care Unit length of stay, and institutionalization. If successful, investigators~     will have sound pilot data for several critical health outcomes with which to support an~     external proposal for a larger-scale study.~   "
60595|NCT02773732|"~     The purpose of the first part of this study is to establish the maximum tolerated dose (MTD)~     of oral ciprofloxacin when given in combination with a fixed dose of oral etoposide in~     patients with resistant acute myeloid leukemia (AML). The purpose of the second part of this~     study is to determine if the established dose of oral ciprofloxacin in combination with oral~     etoposide is effective in the treatment of patients with resistant AML.~   "
60596|NCT02773719|"~     Traditionally, healers are willing to look after, two out of three French citizens have~     already appealed to them at least once during their lives. Many healers in good faith are~     exercising their magnetism as a gift often inherited from elders. Now, they create interest~     of doctors who do not hesitate in some cases to ensure their cooperation, to implicitly~     recognize their mysterious talents. Some serious studies have examined these practices:~     Several studies have been conducted on the influence of biofield therapies in pain,~     depression and fatigue in cancer disease. The investigators propose a study of the effect of~     magnetism on the wart disease whose cure is objectively assessable.~      Sixty-two subjects in total would be included, comparing 2 proportions observed: the~     proportion of healing in the group treated with a real biofield therapist (recognized and~     affiliated to the National Group for Alternative Medicine in France) to the proportion of~     healing in the group treated with a fake biofield therapist (someone assessed as not having~     capacity to magnetize). The fake biofield therapist, placebo, has been trained to replicate~     gestures during a training validated by an independent recognized biofield therapist.~      If the results are in favor of magnetism, this pilot study would encourage additional~     investigations to determine whether the practice of magnetism may be a paramedic~     specialization.~   "
60597|NCT02773706|"~     The DECADES trial seeks to determine the comparative effectiveness of specialist-centered~     management of anxiety and depression vs. an imbedded and automated psychology referral for~     all subjects who screen positive for anxiety or depression.~   "
60598|NCT02773693|"~     The primary objective of the current study is to determine if providing cognitive-behavioral~     therapy of Insomnia and nightmares (CBTin) and Cognitive Processing Therapy of PTSD (CPT)~     results in greater PTSD and sleep symptom reduction than CPT only. A secondary objective is~     to determine if the sequencing of CBTl&N before or after CPT results in differential effects~     on PTSD and sleep symptom reduction.~   "
60599|NCT02773680|"~     Current EIT analyses are based on the assumption of a circular thorax-shape and do not~     provide any information on lung borders. The aim is to obtain the body and lung border~     contours of male subjects by multi-detector computed tomography (MDCT) in defined thresholds~     of anthropometric data (gender = male; height; weight) for calibration of more realistic EIT~     reconstruction models.~   "
60600|NCT02773667|"~     Correlation analysis between estimated renal function and biological half life of 131-I~     during radioiodine treatment of patients with differentiated thyroid cancer.~   "
60612|NCT02773511|"~     The study evaluates the effectiveness of surgical or non-surgical treatment for children type~     1 humeral condyle fracture.Half of the participants receive surgical treatment and the other~     half receive non-surgical treatment~   "
60962|NCT02768935|"~     The prevalence of type 2 diabetes is growing steadily. Patients with diabetes, cardiovascular~     complications (such as myocardial infarction (MI)) are more frequent and severe than in~     non-diabetic subjects. The anti-diabetic therapies available have little or no effect on the~     incidence of cardiovascular events. It is therefore urgent in diabetics develop new~     therapeutic strategies to reduce the occurrence of MI or limit the consequences.~      In the two weeks following MI, monocytes / macrophages are the most represented in the~     ischemic heart tissue cells. The infiltration by monocytes / macrophages after infarction MI~     is a two-phase process. In the first phase, monocytes / macrophages M1 promote digestion~     injured areas, and monocytes / macrophages M2 intervene to promote angiogenesis, collagen~     deposition and contribute to tissue repair. The optimal repair after myocardial infarction~     depends on effective recruitment of monocytes and macrophages M1 transition needed to digest~     the damaged tissue and M2 macrophages necessary for tissue repair. The balance between these~     two phenotypes M1 and M2 is controlled by different modulators, such as transcription~     factors, cellular miRNA and miRNA extracellular contained in the microvesicles (MVs).~     Interestingly, plasma MVs circulating essentially derived monocytes and platelets contain~     miRNA and are impaired by inflammation or during various pathological situations (such as~     IDM). Furthermore, metabolic disorders such as hypercholesterolemia (often associated with~     diabetes) affect the transition from M1 to M2 response and response delay cardiac repair. To~     date, the mechanisms that control the M1 / M2 transition at heart level are not elucidated.~     Moreover, the impact of diabetes, which leads to chronic low-grade inflammation, is not~     explored. Targeting the immune response by promoting the transition M1 / M2 after MI could be~     an innovative therapeutic approach. However, better characterization of the response of M1~     and M2 macrophages after MI and the mechanisms by which they contribute to tissue remodeling~     and the effect of diabetes are needed. The goal is to study how the phenotypes / macrophage~     functions after MI are changed by diabetes and to determine the potential role of miRNAs~     contained in secreted MVs in the transition M1 / M2 after MI.~      Monocytes / macrophages from subjects with normal blood sugar or diabetes who underwent an~     IDM (10 per group) will be characterized phenotypically. Their ability to produce MVs will be~     analyzed. These MVs will be tested functionally for their ability to orient the polarization~     of healthy recipients monocytes. The content of these MVs in terms of miRNAs will be analyzed~     in detail. By bioinformatics analysis, some miRNAs of interest (based on their abundance and~     target genes) will be selected. These miRNAs are over-expressed in macrophages and MVs~     produced by these cells will be analyzed for their ability to modulate differentiation of~     monocytes recipients. Finally, the circulating levels of these miRNAs of interest will be~     measured after 1 year of IDM and will be correlated to the clinical phenotype of patients~     (recurrence, arrhythmias, heart failure). Ultimately, the goal is to identify VMs that can~     promote the differentiation of monocytes to an alternative phenotype and identify miRNAs~     responsible for this effect. This could help in the future, in a subject with impaired~     ability of monocytes to differentiate alternatively, can change by introducing the miRNA of~     interest to re-inject or inject MVs macrophage containing the miRNA of interest and thus~     correct the defect of differentiation.~   "
60602|NCT02773641|"~     Women with provoked vestibulodynia (PVD) suffer from severe dyspareunia and often present a~     hyperactivity of the pelvic floor muscles (PFM) which maintain the dyspareunia. The rationale~     for the study is that for women with PVD who don't succeed to restore the function of the PFM~     by physiotherapy, Botulinum Toxin A (BTA) could be an optional treatment by decreasing the~     high muscle tonus and thus possibly reduce the coital pain.~   "
60603|NCT02773628|"~     Eviction methods for dust mite allergy have been evaluated in asthma control in a recent~     Cochrane meta-analysis. None have shown efficacy on asthma control and there are not~     recommended. The purpose is to evaluate the efficacy of a new commercialized system (Acar'Up)~     to decrease dust mite load and to assess its impact on the possibility to perform inhaled~     corticosteroids step down in stable asthmatics.~   "
60604|NCT02773615|"~     Background In the differential diagnosis of unstable angina versus non-anginal chest pain, an~     exercise test is often the modality of choice for further investigation. However, in a~     substantial number of patients exercise testing is less informative, because of insufficient~     exercise capacity or pre-existing ECG-abnormalities. In patients with low pretest probability~     of coronary artery disease (CAD), Coronary CT angiography (CTA) has an excellent negative~     predictive value, but in patients with an intermediate or high pretest probability of CAD~     estimation of the hemodynamic significance of a stenosis has only limited specificity. CT~     perfusion (CTP) is a new method looking at myocardial perfusion during vasodilative stress~     with a sensitivity, specificity, positive predictive value and negative predictive value of~     respectively 81%, 93%, 87% and 88%, whereas radiation is limited to a maximum of 5~     millisievert (mSv).~      Aim It is the aim of this pilot study to investigate whether the addition of CTP to CTA is a~     feasible and safe investigational workflow in patients with unstable angina or nonanginal~     chest pain in the emergency department.~   "
60605|NCT02773602|"~     Comparing the duration of pain relief from caudal analgesia when adjuncts like dexamethasone,~     clonidine, or saline (salt water) are added to ropivacaine.~   "
60606|NCT02773589|"~     Achalasia is an esophagus motor disability characterized by a lack of relaxation of the lower~     esophageal sphincter (LES) to deglutition. Myotomy is the gold standard surgical technique~     allowing to cure this pathology. In this study, investigators are using a new endoluminal~     technique of myotomy, innovative and less invasive, called POEM (PerOral Endoscopic Myotomy).~     This technique does not require any cutaneous incision.~      Mini-invasive surgery is more and more associated to endoscopy. The practice was initiated by~     the accession of natural orifice transluminal endoscopic surgery (NOTES). In this context,~     the introduction of the POEM technique seems to be an original approach and a natural~     evolution to a new generation of surgical endoscopy.~   "
60607|NCT02773576|"~     A one year, open-label, study to evaluate the safety and tolerability of risperidone implants~     as a maintenance treatment in patients with schizophrenia~   "
60608|NCT02773563|"~     The insufflation of air in the viscera is indispensable during endoscopy. However, the~     distension of the bowel that follows is often the cause of abdominal discomfort.~      Carbon dioxide (CO2) has been widely used for insufflation in endoscopy. CO2 insufflation is~     demonstrated in the literature to cause lower abdominal discomfort as it is quickly~     reabsorbed by the body.~      Endoscopic ultrasonography (EUS) is a method in which you associate the endoscopic view and~     the ultrasound vision obtained from the inside of the viscera.~      The diagnostic accuracy of EUS is undermined by the visual artifacts caused by the presence~     of air between the probe and the organ to be studied.~      Although the use of CO2 is already widely applied by many endoscopists, there are no studies~     to date concerning the use of CO2 during EUS from the point of view of the abdominal~     discomfort related to the procedure and/or the quality of the images obtained.~      The main purpose of the study is to assess whether the insufflation of CO2 results in a~     reduction of discomfort of the patients undergoing EUS. The study design is observational~     because no randomization or other interventions are planned; participants will be assigned to~     either air or CO2 insufflation according to the endoscopic room equipment (one room is~     equipped with CO2 insufflation while another endoscopic room is equipped just with air~     insufflation) and the results of the two groups will be compared. Among the secondary goals~     the investigators want to evaluate whether insufflation of CO2 is associated with a reduction~     in the dose required for patients sedation. Finally, the investigators want to clarify~     whether the use of CO2 is able to produce less visual artifacts than air and thus improve the~     quality of EUS images.~   "
60609|NCT02773550|"~     This clinical trial is a multicenter, cohort, with one arm to study the SLP to 18 months of~     Velcadito scheme (velcade 1.0 mg / m2 administered over two days with melphalan and~     prednisone) in patients with MM diagnosis again higher 75. After completion of the protocol~     patients were still approximately every two months, in clinical practice, to observe the~     survival and answers to other treatments. All the scans are part of the normal routine. The~     realization of diagnostic tests and drug treatment will be performed regardless of the~     patient's participation in the study as part of routine clinical practice All patients who~     meet criteria. The incidence of MM age-adjusted to cover the participating hospitals is~     estimated in 44 patients.~      Patients will receive a course of 4 weeks duration of Melphalan / Prednisone / Velcade~     consist in Melphalan, 9 mg / m2 orally daily 1-4 and Prednisone 60 mg / m2 orally on days 1~     to 4, in combination Velcade with a dose of 1.3 mg / m2 sc twice weekly (days 1, 4, 8, 11),~     followed by 2 weeks of rest (cycle duration of 4 weeks) and seven four-week cycles duration~     of melphalan / prednisone / Velcade consist in Melphalan, 9 mg / m2 orally on days 1 to 4 and~     prednisone, 60 mg / m2 orally on days 1 to 4, in combination with Velcade, at doses of 1, 0~     mg / m2 sc (days 1, 4).~      Melphalan and Prednisone will be dispensed for oral administration. The Melphalan should be~     administered in a single two hours separately taking any food and prednisone be taken in the~     morning with or immediately after a meal. The amount in mg will be calculated based on the~     body surface, to be calculated on day 1 of each cycle. Velcade for administration, calculated~     on day 1 of the cycle will be the same dose throughout the entire cycle. If a patient~     experiences a gain or loss of remarkable weight within the cycle, the dose to be administered~     will be recalculated based on the new body surface. The appropriate amount of Velcadeserá~     dispensed in a sc injection. Velcade dose between two leave at least 72 hours~   "
60610|NCT02773537|"~     The primary aim of this pilot study will be to develop a clinically meaningful,~     patient-centric, and pragmatic protocol to evaluate the comparative effectiveness of~     different strategies for achievement of the ideal balance between analgesia and functional~     mobility following total knee arthroplasty (TKA).~   "
60611|NCT02773524|"~     Advanced Gastro-oesophageal Carcinoma (AGOC) has a poor prognosis, and there is no~     established standard treatment following failure of first and second line chemotherapy.~     Regorafenib (BAY 73-4506) is an investigational oral multi-targeted tyrosine kinase inhibitor~     (TKI) which targets angiogenic (VEGF, TIE-2), stromal (PDGF-β), and oncogenic (RAF, RET and~     KIT) receptor tyrosine kinases, and has shown activity in other solid tumours. Regorafenib~     was shown to prolong PFS across all regions/subgroups in INTEGRATE I The general aim of this~     study is to determine if regorafenib improves overall survival in refractory AGOC.~   "
60615|NCT02773472|"~     A multimodal approach for management of post-operative pain is used to improve analgesia,~     minimize side effects, and improve recovery. Nevertheless, opioid analgesics and intravenous~     patient controlled analgesia remains the mainstay of postoperative analgesia after colorectal~     surgery. Opioids are associated with various side effects such as nausea, vomiting, sedation,~     dizziness, respiratory depression, urinary retention and reduced bowel movement. These side~     effects are unpleasant and lead to prolonged recovery.~      Use of non-pharmacological analgesic techniques may improve postoperative pain control and~     reduce opioid consumption. Acupuncture has been used for over 3000 years in China for~     treatment of pain and various other conditions. Acupuncture and related techniques are simple~     and safe. There is evidence that acupuncture can reduce postoperative pain intensity, opioid~     consumption, and opioid related side effects.~   "
60616|NCT02773459|"~     This study is to test the efficacy of MEK162 plus capecitabine in gemcitabine-pretreated~     advanced biliary tract cancer, and to explore the predictive biomarkers for future~     large-scale clinical trials using this combination.~   "
60617|NCT02773446|"~     The purpose of this study is to determine the safe and optimal dose and regimen (fasting~     duration) for administering the challenge ETEC strain B7A, a CS6 expressing ETEC strain.~      Additionally, an assessment of homologous protection following rechallenge with B7A will be~     assessed.~   "
60618|NCT02773433|"~     The primary aim of this research is to determine the feasibility of conducting a randomized~     controlled trial comparing two ventilation modes in patients admitted to the ICU who require~     mechanical ventilation. The investigators plan to include patients on mechanical ventilation~     with low support (PaO2/FiO2 ratio > 200, FiO2 < 0.5 and PEEP < 8) for a period no longer than~     48 hrs. There are a number of potential barriers to enroll patients in the study. Importantly~     patients will have to be enrolled within 48 hours from the time they meet inclusion criteria.~      The secondary aims are to determine the impact of proportional assist-ventilation (PAV)~     versus volume assist-control (VAC) ventilation by evaluating the number of ventilation-free~     days, development of Intensive Care Unit (ICU) delirium, use of sedative/ analgesic~     medications, use of antipsychotic medications, length of stay in the intensive care unit and~     hospital, reintubations within 24 hours, adverse events, and mortality in the two groups of~     patients.~   "
60619|NCT02773420|"~     Purpose: The current study aims to evaluate the safety and effectiveness of the HET™ Bipolar~     System (Medtronic, Boulder, CO) for the treatment of grade I-II hemorrhoids in a prospective~     pilot study. This device was evaluated retrospectively in a limited cohort of 23 patients~     previously.~      Methods: Patients seen at a colorectal clinic in a single institution with grade I-II~     hemorrhoids are offered to participate in a prospective pilot trial. The HET device is a~     modified anoscope equipped with LED lighting, a tissue clamping mechanism and a bipolar~     energy source used to treat multiple hemorrhoidal columns in one sitting. Three columns of~     hemorrhoids are treated with 2 heat energy applications per column. The primary outcome is~     the treatment effect on hemorrhoid symptoms of bleeding, pain, prolapse, itching, and~     soiling. This is measured with a patient completed questionnaire documenting each symptom's~     frequency from 0 to 3 (i.e. 0 is < 1x/month; 3 is daily) before therapy and at 3 weeks and 6~     month follow-up. Post-treatment pain scores were recorded using the visual analog scale~     (VAS).~   "
60620|NCT02773407|"~     The purpose of the study is to determine whether azithromycin or cotrimoxazole is the best~     empirical treatment for undifferentiated febrile illness in Nepal~   "
60621|NCT02773394|"~     The purpose of the study is to describe: 1) the clinical profile, past and current management~     of participants with hepatitis C in Brazil reference centers; 2) the current situation about~     demographics characteristics, liver disease progression and clinical outcomes in Brazilian~     Hepatitis C virus (HCV) participants naive, in treatment and previously exposed to antiviral~     treatment without sustained virological response (SVR).~   "
60622|NCT02773381|"~     This trial is conducted in Europe. The aim of this trial is to investigate the effect of oral~     semaglutide compared with placebo on postprandial glucose and triglyceride metabolism, energy~     intake, appetite sensations and gastric emptying in subjects with Type 2 diabetes~   "
60623|NCT02773368|"~     This trial is conducted globally. The aim of this trial is comparing glycaemic control and~     safety of insulin degludec/liraglutide (IDegLira) versus insulin glargine (IGlar) as add-on~     therapy to SGLT2i (sodium-glucose cotransporter 2 inhibitors) in subjects with type 2~     diabetes mellitus.~   "
60624|NCT02773355|"~     This trial is conducted in North America. The aim is to investigate timely detection of~     pancreatitis cases as well as cases of suspicion of serious and non-serious adverse reactions~     possibly or probably related to Saxenda® in Mexican patients.~   "
60625|NCT02773342|"~     The incidence of invasive pulmonary aspergillosis (IPA) is increasing in all parts of the~     world. Despite introduction of new antifungal agents for prophylaxis and treatment of IPA in~     the last decade, the outcome of patients with IPA is still unsatisfactory and needs~     improvement. Particularly, recent developments in diagnostic imaging, including introduction~     of high-resolution computed tomography (CT) into standard procedures, made a place for~     improvement of diagnosis of IPA.~      Computed tomography of the chest is the optimal, recommended imaging procedure for diagnosis~     of pneumonia in febrile neutropenic patients and it is significantly superior to conventional~     chest X-ray. However, the method is associated with some difficulties mostly due to the broad~     spectrum of pathological findings in patients with IPA and their evolution over time. This~     has been described in retrospective studies on relatively small groups of patients.~     Prospective studies on larger populations are still missing, as well as studies on~     combination of different diagnostic modalities e.g. diagnostic imaging and microbiology.~      We recently published the results of the clinical trial: A Phase II Dose Escalation Study of~     Caspofungin in Patients with Invasive Aspergillosis which used caspofungin doses of 70 to~     200 mg daily for the first line treatment of IPA. The maximum tolerated dose was not reached,~     but response rates were impressive with complete plus partial responses accounting for 54.3%~     and overall mortality at 12-week follow-up as low as 28.3%. There was a tendency towards~     higher doses yielding higher response rates.~      For the majority of these patients we obtained serial chest CT. So, for the first time a~     patient population is at hand, in which the kinetics of infiltrates over time can be~     described.~      The main objective is to describe the pathological findings in chest CT performed~     sequentially in IPA patients while receiving effective antifungal therapy. The specific~     objectives are:~        1. Characteristics of pathological findings in sequential chest CTs~             -  To describe the pathological findings (e.g. halo sign, air crescent sign and air~               consolidation) in sequential high resolution computed tomogrphy (HRCT) examinations~             -  To calculate the incidence of individual pathological findings in sequential CT~               examinations~             -  To calculate a total volume of fungal infiltrates in sequential CT examinations~        2. Correlation of pathological findings in sequential CT with corresponding white blood~          count (WBC) and absolute neutrophil count (ANC)~             -  To correlate the appearance or disappearance of individual pathological findings~               with WBC and ANC~             -  To correlate the volume of fungal infiltrates in sequential CT examinations with~               WBC and absolute neutrophil count~        3. Correlation of pathological findings in sequential CT with the serum galactomannan index~             -  To correlate the appearance or disappearance of individual pathological findings~               with the serum galactomannan index~             -  To correlate the volume of fungal infiltrates in sequential HRCT examinations with~               the serum galactomannan index~        4. Correlation of pathological findings in sequential HRCT with outcome of IFI~             -  To correlate the appearance or disappearance of individual pathological findings~               with outcome of IFI~             -  To correlate the volume of fungal infiltrates in sequential HRCT examinations with~               outcome of IFI~   "
60690|NCT02772497|"~     The purpose is to show the 3-month efficacy and safety in diabetic macular edema treated with~     intravitreal ziv-aflibercept.~   "
60626|NCT02773329|"~     Cancer patients with chemotherapy-induced peripheral neuropathy (CIPN) have deficits in~     sensory and motor skills leading to inappropriate proprioceptive feedback, impaired postural~     control and high fall risk. This study will investigate the acceptability and effect of an~     interactive motor adaptation balance training program based on wearable sensors for improving~     balance in older cancer patients with CIPN. Cancer patients with confirmed CIPN will be~     recruited and will be randomized to either intervention (IG) or control (CG) group and~     followed for 6 months. The intervention group will take part in a 6-week balance training~     program twice per week in either their home or in clinic (based on subject preference) under~     the supervision of a qualified research staff member. This intervention includes interactive~     game-based balance training including repetitive weight shifting and virtual obstacle~     crossing tasks. Wearable sensors will provide real-time visual/auditory feedback from foot~     and ankle position and allowed perception of motor-errors during each motor-action. The~     control group will be instructed to complete a supervised foot and ankle exercise without~     using sensor technology. Changes in balance, gait, and physical activity, and number of falls~     will be compared pre- and post-intervention, as well as 3 and 6 month post intervention.~     Investigators hypothesize that patients receiving sensor-based exercise training will benefit~     more compared to group receiving conventional non-technology home-based training in terms of~     improving functional performance and reducing falls.~   "
60627|NCT02773316|"~     A study to assess bioavailability of a single dose of MR902 and to assess the effect of food~     on absorption~   "
60628|NCT02773303|"~     This project aims:~        -  to further explore the effectiveness of a novel sonified Neurofeedback management~          therapy for children diagnosed with Autism Spectrum Disorder (ASD)~        -  to determine if balance control is different before and after therapy~   "
60629|NCT02773290|"~     The objective of this study is to evaluate the efficacy of romiplostim administered once~     weekly to Aplastic Anemia (AA) patients with thrombocytopenia refractory to or ineligible for~     immunosuppressive therapy in Japan and Korea.~      Safety and pharmacokinetics of romiplostim after repeated administration will also be~     assessed.~   "
60630|NCT02773277|"~     Due to its localization in the cerebello-pontine angle, the vestibulo-cochlear nerve is at~     risk to damage during surgery performed nearby. In most cases, peripheral-cochleovestibular~     hypofunction recovers over the following weeks as the mechanism of damage is rather~     demyelination than axonal damage. The rate, intensity and extent of recovery of such~     perioperative peripheral-vestibular damage is not known.~   "
60631|NCT02773264|"~     This is a prospective, single-center, non-randomised, non-blinded trial with US Elastography~     of Patients referred to our institution to assess soft tissue and organ lesions. All patients~     will undergo next to the clinical indicated conventional US-examination, US Elastography~     after informed consent. After completion of these three examinations, the participation in~     the study is completed.~   "
60632|NCT02773251|"~     To assess the anti-adhesive effect of treatment with hyaluronic acid-carboxymethylcellulose~     following laparoscopic pelvic surgery (radical prostatectomy).~   "
60633|NCT02773238|"~     This phase II trial studies how well positron emission tomography (PET)/computed tomography~     (CT) and single positron emission computed tomography (SPECT)/CT imaging works in improving~     radiation therapy treatment in patients with stage IIB-IIIB non-small cell lung cancer.~     PET/CT imaging mid-way through treatment may be able to accurately show how well radiation~     therapy and chemotherapy are working. SPECT/CT imaging may be able to tell which parts of the~     lung tissue are healthier than others. Based on the result of the imaging, treatment~     adjustments may be made to the radiation therapy to improve survival and decrease toxicity.~   "
60634|NCT02773225|"~     The aim of this study is to improve treatment of Moderate Aplastic Anemia (MAA) by evaluating~     the safety and efficiency of Eltrombopag as a new treatment option in patients with therapy~     requiring MAA.~   "
60635|NCT02773212|"~     The purpose of this study is to examine anhedonia as a potential moderator of treatment~     outcomes for Cocaine Use Disorder (CUD). Specifically, this study will investigate how~     anhedonia affects outcomes in contingency management (CM) treatment for CUD and whether~     anhedonia mediates the effects of adjunctive treatment with a dopaminergic (DAergic) drug,~     d-amphetamine, on outcomes in CM for CUD, as well as investigate the contribution of~     anhedonia to overall CUD severity.~   "
60636|NCT02773199|"~     This study compares differences in hemodynamic ve ECG parameters of patients undergoing~     urological or orthopedic surgery under spinal anesthesia. First group will comprise of~     patients undergoing surgery in the morning hours; thus with a standard fasting duration (8~     hours), and the second group will comprise of patients undergoing surgery afternoon; thus~     having a prolonged fasting duration (>12 hours).~   "
60637|NCT02773186|"~     The main objective of the present study was to evaluate whether cerebral oxygen saturation is~     associated with an increase of NPOBC in pediatric patients undergoing major surgery.~   "
60638|NCT02773173|"~     The purpose of this study is to assess the post-operative recovery quality of the~     Individualized Pneumoperitoneum Pressure Therapy in Colorectal laparoscopic surgery versus~     standard therapy using a quality validated scale of postoperative recovery of their stay in~     the Post-Anaesthesia Recovery Unit.~   "
60639|NCT02773160|"~     A large subgroup of patients with chronic non-specific low back pain have motor control~     impairments. During motor control exercises, different forms of external feedback can be used~     to support training. This randomized controlled trial will investigate the effectiveness of~     different forms of external feedback during the learning phase of a motor control task for~     the lumbar spine in healthy subjects and patients with chronic non-specific low back pain~     (CNSLBP). Both healthy subjects and patients with CNSLBP will be randomized into three~     groups: one group will receive feedback from motion sensors, one group from a mirror and one~     group will receive no feedback (control group). A single session intervention with~     measurements at baseline and immediately post-intervention will be used.~   "
60640|NCT02773147|"~     The purpose of this study is to investigate if B vitamin substitution have effect on NFL~     (neurofilament light protein) plasma levels and neurocognitive performance in HIV-infected~     individuals with increased plasma homocysteine~   "
60719|NCT02772107|"~     Temozolomide may delay progression in sequence with chemotherapy. This open-label,~     randomized,multicenter phase II trial was designed to evaluate the role of Temozolomide~     following 4 or 6 cycles of platinum-based first-line chemotherapy in patients with newly~     diagnosed estensive-stage SCLC.~   "
60641|NCT02773134|"~     Braces are commonly prescribed after posterior spinal instrumented fusion (PSIF) in patients~     with lumbar degenerative conditions with the aim of improving pain relief and quality of~     life. However, there is a lack of evidence on the indication for postoperative bracing, as~     surgeons choose to use braces mainly based on their experience and training.~      The aim of this study is to investigate whether wearing a brace after PSIF can improve pain~     relief and quality of life (QOL) 6 weeks and 3 months after surgery.~   "
60642|NCT02773121|"~     The goal of this research study is to examine whether an intervention to increase physical~     activity using a body-worn sensor affects cognitive (thinking) processes.~   "
60643|NCT02773108|"~     Prevalence of somatic comorbidities in psychiatric patients hospitalized in Psychiatric~     hospital or treated ambulatory or in daily hospital. Comparison of prevalence of somatic~     comorbidities in psychiatric patients population and the general Croatian population.~   "
60644|NCT02773095|"~     Countries throughout the world are facing a growing non-communicable disease (NCD) burden. In~     developing countries, medicines to treat NCDs are often difficult to access or too expensive~     for many households. Novartis/Sandoz has recently launched Novartis Access, an initiative to~     subsidize a basket of NCD medicines sold to purchasers in program countries and delivered~     through the public and non-profit health sectors. This study will evaluate the impact of~     Novartis Access on the availability and price of NCD medicines at health facilities and~     households in Kenya, the first country to receive the program.~   "
60645|NCT02773082|"~     There are two primary approaches to the treatment of OCD, pharmacotherapy and cognitive~     behavior therapy (CBT). Lack of therapeutic success with one approach leads to trials of the~     alternative approach or a combination of the two. A rarely used third therapy approach,~     appropriate for only the most severely afflicted and treatment resistant patients, is~     neurosurgical ablation of certain brain regions involved in mood and anxiety. The~     neurosurgical ablation procedures are irreversible in nature, and involve the destruction of~     specific volumes of brain tissue through various controlled means.~      Surgical procedures include cingulotomy, subcaudate tractotomy, limbic leucotomy which is a~     combination of the first two procedures and capsulotomy. DBS therapy is an alternative to~     neurosurgical procedures, specifically anterior capsulotomy, for patients with chronic,~     severe OCD which has proven resistant to primary pharmacological and/or behavior therapy~     options.~      Results from 26 severe, treatment-resistant OCD patients treated with DBS at four~     collaborating centers, three in the US, and one in Europe are summarized in great detail in~     pages 12-22 of the provided/attached Reclaim Summary of Safety and Probable Benefit.~   "
60646|NCT02773069|"~     The proposed Church Bridge intervention project will provide an innovative, evidence-based~     and technology supported, health intervention model for Southern, African American, and rural~     populations who continue to be disparately burdened by obesity and associated co-morbidities~     (i.e., hypertension, diabetes, cardiovascular disease). By targeting young adults (21-50~     years of age) with families, the project will contribute to the long-term reduction of~     preventable chronic disease and related health care costs for the public.~   "
60647|NCT02773056|"~     The primary objective of this clinical trial is to determine if the Dynamic Socket and~     Sub-Ischial alternative interface designs improve socket comfort, residual limb health,~     increase function and be preferred over the standard of care Ischial Ramus Containment (IRC)~     interface for the military and veteran living with transfemoral limb loss.~   "
60648|NCT02773043|"~     The proposed study is to validate a non-invasive imaging technique to evaluate the myocardial~     perfusion reserve in comparison with a validated invasive technique, the measure of coronary~     flow reserve (CRF) with thermodilution.~   "
60649|NCT02773030|"~     This is a multicenter, multicountry, open-label, Phase 1b/2a dose-escalation study to~     determine the maximum tolerated dose of CC-220 when administered as monotherapy and in~     combination with dexamethasone. The study will consist of an escalating dose-escalation~     portion (Part 1) as well as an expansion of each cohort (ie, Cohort C: Monotherapy (MonoT)~     and Cohort D: Combination treatment with 2 drugs (DoubleT) at the recommended Phase 2 dose~     (RP2D) to further evaluate safety and estimate preliminary efficacy (Part 2).~   "
60650|NCT02773017|"~     Dexmedetomidine(DEX) could provide dose-dependent sedation , analgesia , anti-anxiety and~     inhibition of sympathetic nerves and other effects. Because of its minimal impact on the~     respiratory , currently it was more and more widely used to sedate patients undergoing~     regional anesthesia.Many anesthetic pharmacokinetics and pharmacodynamics are often affected~     by age, and current studies with regard to the effects of age on dexmedetomidine~     pharmacodynamic are rare. This study was designed to explore the right DEX dose of different~     female Age of patients to produce suitable sedation.Dexmedetomidine be used in patients with~     combined spinal and epidural anesthesia for sedation,which is monitored by the~     Narcotrend,during the operation.The relation between Narcotrend index (NTI) and the depth of~     sedation for patients is also investigated.~   "
60651|NCT02773004|"~     The trial population of this study is composed of women aged more than 18, who have developed~     a newly node-negative (or pN1mi), Estrogen Receptor (ER)-positive, Her2-negative invasive~     breast cancer with uncertainty on the indication of adjuvant chemotherapy using standard~     assessments.~      Obtaining material for test is at no risk as done from the surgery material. Tumor molecular~     EndoPredict (EP)clin analysis will allow to obtain information on the expression of 8 breast~     cancer related genes and will provide important prognosis indications. Clinical validation~     studies have demonstrated that molecular assays are useful for stratifying patients into risk~     categories and helpful in making clinical treatment decisions in ER+/node-negative breast~     cancer patients.~   "
60652|NCT02772991|"~     In recent years, a large number of studies have been conducted on how to improve the~     treatment of patients in the Emergency Room (ER) complaining of chest pains. Great advances~     have been achieved recently regarding diagnostic methods aided by coronary CT angiopraphy~     (CCTA) and sensitive troponins. However, various questions about these methods still remain~     obscure and there is no effective comparison between them in patients with intermediate risk.~     The aim of the study is to evaluate the sensitivity and specificity of sensitivity troponins~     in the detection of coronary artery disease in patients with chest pain and the intermediate~     probability of ACS compared with CCTA.~   "
60653|NCT02772978|"~     This study deals with how people decide between rewards of different value. We want to~     understand how the brain's dopamine system impacts this kind of decision making. We will use~     a medication, tolcapone, which can temporarily affect the dopamine system.~   "
60655|NCT02772952|"~     Objective: To compare short-term and medium-term effectiveness of a multimodal program that~     integrates a program of therapeutic exercise, medication review, adequacy of diet and health~     education, compared with standard medical practice in improving neuromuscular and~     physiological status on frail elderly. Another aim is to analyze the maintenance of these~     effects by monitoring long-term (12 months) from the start of the intervention.~      Design: Randomized controlled trial Scope / Study subjects: recruited frail elderly in Basic~     Health Zone of Malaga. Methods: The subjects to be included in the study (after meeting~     inclusion / exclusion) will be randomized into two groups: a control group whose intervention~     will be to review medication + adequacy of diet + health education (physical activity~     recommendation (within a comprehensive advice on healthy lifestyles) and an experimental~     group whose intervention will be a Multimodal Intervention: therapeutic exercise + review~     medication + adequacy of diet + health education program.~      Sociodemographic, Clinical and monitoring Variables will be collected at baseline. Moreover,~     tracking variables will be collected at 2 and 6 months after starting the intervention and at~     3 and 6 months after the end of the intervention (monitoring).~      The monitoring variables that will be measured are: BMI , general health, fatigue,~     brittleness, Motor Control, Attention - Concentration - Memory, Motor Memory , spatial~     orientation, grip strength, balance (static - semi-static and dynamic ), gait speed and~     metabolomic variables.~      One descriptive analysis of the sociodemographic variables of the participants will be~     performed. Further the change on the variables intra-subjects (pre-post intervention) and~     inter-subjects (experimental group vs control group) will be calculated. For the~     intra-subject analysis will be performed a ANOVA-one factor analysis. The intersubject~     outcome variables will be compared between the two groups in each moments of data collection,~     using the student t-test or Wilconxon (depending of the sample distribution). The level of~     significance was set at P ≤ 0.05.~   "
60656|NCT02772939|"~     This trial is designed to establish invasive and non-invasive measures of arterial stiffness~     as potential predictors of treatment response to renal sympathetic denervation~   "
60657|NCT02772926|"~     Several mechanisms have been implicated in the pathophysiology of the complications of~     diabetes mellitus (DM), one of them is the formation and accumulation of a heterogeneous~     group of compounds called advanced glycation end products (AGEs). The interaction of these~     compounds with their receptor, the receptor for advanced glycation end products (RAGE)~     triggers several signalling pathways which will lead to increase in inflammatory molecules~     and enhanced reactive oxygen species. In addition, to the membrane receptor RAGE, there are~     two soluble forms, the soluble RAGE (sRAGE) and the endogenous secretory RAGE (esRAGE), these~     soluble receptors are capable to bind AGEs and block the AGE-RAGE axis. It has been observed~     that in diabetes the needs of thiamine are increased, and it could be an inhibition of the~     pentose phosphate pathway (thiamine is an essential cofactor in this pathway) and activation~     of other metabolic pathways among them AGEs formation. It has been proposed that~     supplementation of benfotiamine could decreased the risk of micro and macrovascular~     complications, and this could be in part because a decreased in the formation of AGEs. For~     this reason, the objective of this study was to evaluate the effect of benfotiamine on AGEs~     and its soluble receptors (sRAGE) in patients with type 2 diabetes.~      The specific objectives in the current study are:~        1. To evaluate and compare clinical and anthropometric characteristics in type 2 DM~          patients with and without benfotiamine treatment.~        2. To evaluate and compare in type 2 DM patients with and without benfotiamine treatment~          the following biochemical parameters: total AGEs, Carboxymethyl-lysine (CML), sRAGE,~          glucose, hemoglobin A1c, lipids (total cholesterol, C-HDL, C-LDL, and triglycerides).~        3. To evaluate and compare dietary data such as dietary AGEs and macro and macronutrients~          in type 2 DM patients with and without benfotiamine treatment.~      Type of study: This is a randomized, controlled, double-blind clinical trial~      Methods 34 patients will be recruited, 17 per group. After signing the inform consent~     subjects will be assessed for inclusion criteria. Subjects meeting the inclusion criteria and~     those whom accept to participate will be randomized to receive either a placebo or~     benfotiamine treatment for 12 weeks.~      At the end of the 12 weeks all the basal assessments will be repeated.~   "
60658|NCT02772913|"~     Acute mesenteric ischemia is a life-threatening condition characterized by high mortality if~     unrecognized early. This multicenter retrospective observational study will review the~     emergency departments's (ED) notes of all patients discharged from hospital with a diagnosis~     of acute mesenteric ischemia in 2014-2015 comparing it with those admitted to the ED for~     abdominal pain in the same timeframe.~   "
60659|NCT02772900|"~     Aging has been associated with reduced bioavailability of nitric oxide (NO) and endothelial~     dysfunction. Beetroot consumption, a nitrate-rich food, has been associated with increased NO~     bioconversion, which may promote beneficial effects on vascular health. The present study~     evaluated the effects of a beetroot-based nutritional gel (BG) on vascular function, arterial~     stiffness and blood pressure in the elderly at cardiometabolic risk. Twenty elderly~     individuals were submitted to BG and nitrate-depleted gel (PLA) interventions. Brachial~     flow-mediated dilation (FMD), blood flow velocity (BFV), peak wave velocity (PWVβ),~     augmentation index (AI), stiffness parameter (β), pressure-strain elasticity modulus (Ep),~     arterial compliance (AC), muscle oxygenation and function were measured 90 min after~     interventions. Urinary nitrate, nitrite, systolic blood pressure (SBP), diastolic blood~     pressure (DBP) and heart rate (HR) were measured at baseline, 90 min and 150 min after~     interventions.~   "
60660|NCT02772887|"~     The purpose of this study is to determine if oral of L-citrulline (3 grams/day) for 3 weeks~     provided in mid-pregnancy to pregnant women with type 2 diabetes will increase the plasma~     L-arginine/ADMA ratio, lower maternal blood pressure and increase maternal levels of~     placental growth factor (PlGF).~   "
60661|NCT02772874|"~     Fecal incontinence (FI) is clinically subtyped as urge FI and passive FI based on symptoms,~     however the pathophysiologic significance of this subtyping is not known. FI is commonly~     encountered in women with pelvic floor disorders. This study aims to compare characteristics~     of clinical severity, quality of life, anatomy, and physiology of urge FI versus passive FI.~     Urogynecology patients greater than age 18 with FI at least monthly over the last 3 months~     will be recruited for participation. Participants will be divided into urge FI subtype and~     passive FI subtype. Participants will complete validated questionnaires on clinical severity~     and quality of life, both as related to FI and general heath. Participants will undergo~     pelvic examination, endoanal ultrasound and anorectal manometry for evaluation of anatomic~     and physiologic pathology. Results between both groups will be compared. The investigators~     hypothesize that clinical, anatomic, and physiologic characteristics differ between~     urge-predominant fecal incontinence and passive-predominant fecal incontinence in women with~     pelvic floor disorders.~   "
60662|NCT02772861|"~     There are many forms of small bowel disease but their direct consequences on small bowel~     function are often very hard, if not impossible, to establish. It would be helpful if there~     was a reliable blood test to find out how well cells in the intestine are working. The amino~     acid citrulline is produced mainly by these cells, and therefore holds promise as a~     biological marker. Some previous studies have shown that fasting citrulline gave a good~     indication as to how many intestinal cells were present. However, other authors have not been~     able to confirm this.~      Most of the citrulline in the blood is derived from another amino acid, glutamine, in a~     metabolic process that occurs in the intestinal cells, and most of the remainder comes from~     another amino acid, arginine. A further potential marker of intestinal cell function is the~     amino acid 3-methylhistidine. It is possible that a dynamic test, which incorporates time for~     conversion from one amino acid to another in the intestinal cells, might perform better.~      The investigators therefore propose a study of oral glutamine, arginine, and~     3-methylhistidine compared with citrulline itself or placebo (glucose) as it is hypothesized~     that these might increase the amount of citrulline more reproducibly. An initial study in~     healthy subjects is required to establish whether this is true, and if so to provide a normal~     range prior to investigation of patients who have or who might have the short bowel syndrome,~     and in whom the test would be clinically useful.~      In this study, the subjects will take each of the amino acids and placebo in random order.~     Between each 6 hour-long visit the subjects will have at least one week where they are~     independent of the research team and during which they can behave normally. During each visit~     subjects will have a sequence of blood samples from an in-dwelling venous cannula, taken~     before and over 6 hours after a single small oral dose of that day's amino acid given as a~     small volume drink. Urine will also be collected for amino acid assay.~   "
60663|NCT02772848|"~     The study objectives are described below:~        1. Obtain serum specimens collected for one ovulatory cycle or a maximum of 33 days, but~          not to exceed a total of 550 ml of whole blood per subject from a minimum of 60 healthy,~          premenopausal subjects. Specimens will be used to determine a reference range for~          estradiol, FSH, LH, and progesterone assays, used as an aid in the assessment of~          fertility in adult, premenopausal women.~        2. To store any remaining specimens for use in future assay development and to evaluate as~          yet undetermined assays for the development of IVDs, including additional estradiol,~          FSH, LH, and progesterone assays.~   "
60664|NCT02772835|"~     The purpose of this study is to compare the effects of two different techniques of~     non-invasive ventilation (nCPAP and nHFOV) on gas exchange in preterm infants recovering from~     respiratory distress syndrome.~   "
60665|NCT02772822|"~     The primary objective of the study is to assess the efficiency of SCT400 plus CHOP versus~     Rituximab plus CHOP in untreated CD20-positive DLBCL Patients.~      The secondary objective of the study is to evaluate the safety of SCT400 plus CHOP, as well~     as the presence of human anti-chimeric antibodies (HACA).~   "
60666|NCT02772809|"~     Stroke survivors with hemiplegia will be evaluated by rehabilitation professionals and asked~     to perform a battery of assessments to test the viability and usability of a force-feedback~     robot that adapts to each individual subject's performance. Subsequently, they will be asked~     to complete post-assessment questionnaires that provide feedback to the researchers on their~     observations and thoughts about the therapy devices.~   "
60667|NCT02772796|"~     This study is to aid the development for the use of SENS-218 outside its marketed therapeutic~     indications. SENS-218 is available in Asia and is marketed as an anti-emetic (Anti-sickness)~     drug often prescribed after exposure to chemotherapy. Chemotherapy exposure can often induce~     nausea and/or vomiting.~      The study only involves the one drug, referred to as SENS-218 in this study. The purpose of~     the study is to support the development of use of SENS-218 in non-Asian population.~      The key objective of this study is to identify the pharmacokinetic (PK) parameters of the~     drug in healthy Caucasian population. The PK refers to what the body does to the body, for~     example, how quickly the drug is absorbed into the blood stream.~      The population who are eligible to take part in the study are healthy male and female,~     non-smoking volunteers, aged between 18 and 50 years, as determined by screening tests at~     Simbec.~      Participation in the trial will last for about 3 weeks (from first screening visit to final~     end of study visit).~   "
60668|NCT02772783|"~     Processed carbohydrates cause rapid changes in blood sugar and have been associated with~     overeating and obesity. We have shown that test meals high in processed carbohydrate affect~     brain areas involved in addiction, craving and overeating. It is unknown whether the changes~     in blood sugar or the associated higher insulin levels mediate this brain activation and its~     likely adverse effects.~      Answering this question is important for patients with type 1 diabetes who have elevated~     risks of obesity and disordered eating: If blood sugar is the causal mechanism, optimal~     insulin coverage should be protective. If insulin is the causal mechanism, however, a diet~     high in processed carbohydrate could predispose to overeating and weight gain, as this diet~     requires higher insulin doses.~      To disentangle these factors, we will study brain activation and relevant blood markers in 15~     men with diabetes. In 4 sessions, we will examine meals with differential carbohydrate~     properties while giving insulin infusions.~   "
60669|NCT02772770|"~     Pediatric ACL: Understanding Treatment Outcomes (PLUTO) is a multi-center, prospective cohort~     study. Specific aims of PLUTO are to evaluate the safety and comparative effectiveness of~     non-operative treatment, as well as four operative treatments including (1) transphyseal ACL~     reconstruction (2) partial transphyseal ACL reconstruction, (3) physeal-sparing epiphyseal~     ACL reconstruction using the Anderson technique, and (4) physeal-sparing ACL reconstruction~     using the Micheli/Kocher technique in prepubescent and pubescent skeletally immature~     patients.~   "
60670|NCT02772757|"~     The overall aim of the study is to compare the verification accuracy and hearing-aid outcomes~     between the traditional, fitting approach where the patient is present during the visit and a~     coupler-based fitting approach where the patient is not present and mailed their hearing~     aids. If the coupler-based fitting protocol tested in this study as effective as the~     traditional fitting protocol, then patients receiving replacement hearing aids may circumvent~     a face-to-face visit.~   "
60671|NCT02772744|"~     This is a prospective, cohort study in Faculty of Medicine, Zagazig University, Egypt. From~     June to December, 2016, investigators will follow up patients with chronic Hepatitis C virus~     genotype 4 receiving daclatasvir-sofosbuvir treatment regimen within the national program of~     Egyptian ministry of health and population. The primary outcomes are safety of the treatment~     and the sustained virologic response 12 weeks after discontinuation of therapy. For the~     secondary outcomes, investigators will measure the change in health related quality of life~     and investigate the genetic sequence of viral RNA of resistant patients.~   "
60672|NCT02772731|"~     Breast cancer is the most common malignancy affecting women in the US. Surgical management is~     the mainstay of therapy, and in general consists of resection of the primary tumor with~     either a partial mastectomy (aka lumpectomy) or a total mastectomy.~      The investigators hypothesize that routine shave margins during partial mastectomy will~     significantly reduce positive margin rate. A positive margin means that cancerous cells were~     detected at the edge of the excised area. This generally mandates a return to the operating~     room for re-excision.~   "
60673|NCT02772718|"~     The purpose of this study is to evaluate the safety and clinical pharmacology of XOMA 358 in~     patients with hypoglycemia after gastric bypass surgery.~   "
60674|NCT02772705|"~     The purpose of this study is to find out the capacity of standardized uptake value (SUV)~     using single-photo emission computed tomography and computed tomography (SPECT/CT) in~     diagnosing Grave's Disease (hyperthyroidism).~   "
60675|NCT02772692|"~     Whether functional consumption is influenced by defecation postures is unclear. The~     investigators investigated effects of defecation postures on functional consumption.~   "
60676|NCT02772679|"~     The purpose of this study is to assess the safety of Tregs + IL-2 and survival of Tregs in~     patients with recent onset T1DM who receive infusions of autologous Tregs + IL-2.~   "
71182|NCT02635269|"~     This study aims to characterize the pathophysiological mechanisms of 21 different metabolic~     myopathies. The study will focus on exercise capacity and the metabolic derangement during~     exercise.~   "
60677|NCT02772666|"~     This study is to evaluate the ability of a newly designed device, Optic Nerve Glass (O-Glass)~     to detect relative afferent pupillary defect (RAPD). In this prospective study, 44 patients~     (diagnosed RAPD- positive) enrolled the study. They were examined for an RAPD by O-Glass and~     also manual swinging flashlight method (SFM) . This newly designed instrument captures and~     records eye pictures. The images will be processed and analyzed using computerized software~     to calculate pupillary measurements.~   "
60678|NCT02772653|"~     Severe trauma patients have an elevated risk of multiple organ failure and death. In order to~     increase survival possibilities the initial treatment must be focused into resuscitation from~     shock. Traditionally the most common resuscitation markers used are vital signs and urine~     output. Unfortunately, many patients might present normal vital signs, but still undergo a~     compensated shock with persistent acidosis, hence being able to develop multiple organ~     failure and death. Consequently, it is important to define better resuscitation markers for~     these patients.~      This investigation project consists in an observational prospective study, performed by a~     multidisciplinary team, in which different resuscitation markers are evaluated in severe~     trauma patients. There will be a specific timing (1st, 8th and 24th hours from arrival)~     evaluation of different markers: hemodynamic (vital signs, urine output, etc); analytical~     (lactate, base excess, natriuretic atrial peptide); tissue perfusion markers (NIRS);~     microcirculation markers (videomicroscopy) and coagulopathy markers (thromboelastometry).~     There will be a registry of total volume administration; blood cell transfusions and~     vasoactive drug requirements. Each marker will be evaluated in relation to mortality;~     multiple organ failure; massive transfusion protocol activation; blood cell transfusion~     requirement; surgical control of bleeding requirement and emergent arteriographic~     embolization. The objective of this study is to demonstrate which of these markers is better~     to predict hemodynamic evolution of severe trauma patients and might become a guide for~     resuscitation in the future.~   "
60679|NCT02772640|"~     The aim of the study is to demonstrate, whether the time of day of administration of the~     study drug (containing rosuvastatin and ezetimibe) has an impact on the effectiveness of~     lipid-lowering therapy.~   "
60680|NCT02772627|"~     The purpose of this study is to investigate the tolerability and safety of three multiple~     dose regimens of nebicapone (BIA 3-202 100 mg, 200 mg, and 300 mg 6 times daily) in healthy~     volunteers. To characterise the steady-state pharmacokinetic and erythrocyte COMT inhibition~     profiles of nebicapone in healthy volunteers.~   "
60681|NCT02772614|"~     The purpose of this study is:~      To determine the rate and routes of excretion of BIA 3-202 and the mass balance in urine and~     faeces To determine the kinetics of total radioactivity in blood To determine the kinetics of~     total radioactivity in plasma To determine the kinetics of BIA 3-202 and its metabolites in~     plasma~   "
60682|NCT02772601|"~     To assess the influence of risankizumab on kinetics of cytochrome P450 (CYP) probe drugs as a~     means of predicting drug-drug interactions.~   "
60683|NCT02772588|"~     The purpose of this study is to determine whether anti-testosterone medications, when~     administered before, during, and after high-dose, precision radiation, will be effective in~     preventing the prostate cancer from returning.~   "
60684|NCT02772575|"~     The purpose of this study is to see if certain genes the tumor can help predict how the tumor~     will respond to Trans-Arterial Embolization (TAE). A gene is the basic physical and~     functional unit of heredity. Genes are made up of DNA; DNA (deoxyribonucleic acid) is the~     hereditary material in humans. Identifying a gene that can predict how liver tumors will~     respond to TAE will also help to determine if adjuvant therapy will be needed after TAE.~   "
60685|NCT02772562|"~     The purpose of this study is to see how well PROSTVAC -V/F works in stopping prostate cancer~     from coming back or relapsing. This study will also look at the safety of PROSTVAC-V/F.~   "
60686|NCT02772549|"~     Patients with newly diagnosed IPF are investigated for the diagnostic delay before a~     diagnosis of IPF is made.~   "
60687|NCT02772536|"~     Background~      An earlier pilot study provided evidence that about 40% of tinnitus sufferers reported that~     viewing particular tints of light appeared to result in some improvement of their tinnitus.~      This ameliorative effect appeared to be primarily acute and only reported to occur whilst~     viewing the tint. Individual patients would choose differing tints with some identifying more~     than one tint that affected their tinnitus.~      Aim of the Study~      In this current basic science study, the aim is to provide preliminary data to return~     estimates of the efficacy of using tinted light to ameliorate tinnitus.~      After identification of responders during screening, responders are invited to attend three~     further trial sessions, where their tinnitus is assessed in response to three luminance~     conditions: Low Ambient Light; Tint of Light affecting Tinnitus; White Light.~      The response to low ambient light serves as a control to compare the effect of tinted light~     against and the response to white light serves as an 'active' stimulus comparator.~      These results will then establish whether tinted light provides patients with a useful~     improvement in their tinnitus compared with measures of their baseline tinnitus obtained in~     the dark and against a standardised white light stimulus.~      They will also inform further development of the technique as a potential treatment for~     tinnitus in responsive patients.~      Over the three sessions, the averaged responses given by the patient under each stimulus~     condition will be analysed to provide a measure of efficacy.~   "
60688|NCT02772523|"~     Recent epidemiologic studies are identifying a number of modifiable risk and protective~     factors that may influence in the incidence of Alzheimer's disease (AD). Therefore, the~     combination of an early detection of individuals at risk together with interventional studies~     targeted to the control of modifiable risk factors makes primary prevention programmes to~     become a new and real therapeutic strategy.~      In this scenario, the investigators have designed the ALFAlife study, a programme of control~     and intervention on the modifiable AD risk factors. Throughout this study, participants will~     be given a number of healthy lifestyle guidelines that are personalised depending on their~     specific risk profile. These guidelines refer to smoking and dietary habits and physical,~     cognitive and social activity. The investigators hypothesis is that the follow-up of these~     guidelines will favor a change of participants' lifestyle habits towards healthier ones. In~     addition, the investigators hypothesise that changes in these lifestyle habits will have an~     effect on objective physiological measures (such as blood pressure and cholesterol levels).~   "
60691|NCT02772484|"~     The HS-1000 device, an investigational intracranial monitoring device, has the potential to~     safely and quickly diagnose and assess stroke (and potentially other neurologic conditions)~     with minimal discomfort to patients. HS-1000 has the capability to establish cerebral~     hemodynamic measurements in suspected stroke within minutes, assist with appropriate~     management of stroke, and also provide an objective diagnostic tool for clinicians to monitor~     recovery.~   "
60692|NCT02772471|"~     Invasive intracranial pressure (ICP) monitoring, using modalities such as parenchymal~     pressure transducer or external ventricular drain (EVD), provides an ICP waveform that~     encapsulates valuable diagnostic and monitoring clinical information.~      HS-1000 device, a proprietary new non-invasive ICP monitor, is expected to display an ICP~     waveform safely and accurately with minimal discomfort to patients, compared to standard~     invasive ICP monitoring procedures used at the participating institutions.~   "
60693|NCT02772458|"~     Crohn's disease (CD) is becoming more common, specifically in the western world. One of the~     main features of this disease is weight loss and malnutrition. Although clinically common,~     these problems are not well understood. Loss of appetite and symptoms such as tummy aches and~     bloating are common causes for weight loss in this group of patients. This problem has a~     strong negative effect on the patients' quality of life and significantly increases the cost~     of treating CD. Enteroendocrine cells are nutrient sensors in the bowel that relay to the~     brain to control food intake. Recent evidence has showed that these cells increase in number~     in active CD and secrete more hormones that negatively affect appetite. The increased levels~     of these hormones should have an overall negative effect on the brain and thus decrease food~     intake, bloating, symptoms of sickness. All these symptoms lead to malnutrition. These are~     hypotheses that require further proof. Current technological advances in magnetic resonance~     imaging (MRI) has enabled the mapping of changes in activity in important areas in the brain~     that control food intake. The involvement of the brain in control of food intake is still not~     fully understood. This work will be the first step in the right direction to start targeting~     the problems of appetite, weight loss and a poor quality of life.~   "
60694|NCT02772445|"~     The purpose of this study is to refine STROKE-CARE for caregivers and explore changes in~     caregiver and care-recipient outcomes~   "
60695|NCT02772432|"~     This study has three aims:~      Phase I: Through focus group interviews with expert clinicians, leaders of organizations, and~     parents with children with special needs, this study aims to identify the psychosocial needs~     of parents of children with learning disabilities, specifically a) the types of concerns that~     parents find most difficult and stressful b) areas of concern that lack support and~     resources, and c) areas of need for education and skill training. This study also aims to~     gather feedback on the Benson-Henry Institute's Relaxation Response Resiliency Program (3RP).~      Phase II: Informed by Phase I findings, this study aims to develop and determine the~     feasibility and acceptability of a virtual 8-session Relaxation Response Resiliency (3RP)~     program for parents of children with Specific Learning Disabilities (SPLD).~      Phase II: This study also aims to test the effectiveness of a pilot wait-list control trial,~     establishing efficacy of a virtual resiliency program.~   "
60696|NCT02772419|"~     The objective of this study is to evaluate the efficacy and safety of SC administrations of~     Benralizumab or Placebo in the subjects with Eosinophilic Chronic Rhinosinusitis in a~     multicenter, randomized, double-blind, placebo-controlled study. The pharmacokinetics and~     immunogenicity will be assessed secondarily.~   "
60697|NCT02772406|"~     The purpose of the study is to determine whether a new colonoscopic viewing technique called~     Linked color imaging(LCI) helps endoscopists detect more dysplasia lesions in ulcerative~     colitis patients than conventional colonoscopy using white light alone.~   "
60698|NCT02772380|"~     The main purpose of this clinical study is to collect electrograms from an investigational~     lead placed in an extravascular space, for development of a future Implantable Cardioverter~     Defibrillator (ICD) system.~   "
60699|NCT02772367|"~     The purpose of this study is to investigate whether cells from a biopsy taken from the~     patient skin can be transformed into cardiomyocytes the changes in cardiomyocyte (heart~     muscle cells) when grown in a special culture medium outside of the body. The structure and~     function of these cells will then be studied to determine why some patients with breast~     cancer who are treated with chemotherapy including anthracycline (e.g. Doxorubicin) and~     anti-HER2 therapy (e.g. Herceptin) develop decreased heart function.~   "
60700|NCT02772354|"~     To evaluate the effectiveness and safety of catheter ablation of frequent symptomatic PVCs in~     the pediatric population as first-line therapy compared with antiarrhythmic drugs.~   "
60701|NCT02772341|"~     Background: Asthma is a chronic inflammatory disorder requiring intermittent or continuous~     anti-inflammatory therapy. Patients often turn to alternative treatments as complements or~     replacements to conventional treatments.~      Aim: To evaluate the effect of salt room chambers (halotherapy) on bronchial hyper-~     responsiveness (BHR), fractional exhaled nitric oxide (FeNO), and quality of life in children~     with asthma.~      Patients: Children aged 5-13 years with a clinical diagnosis of mild asthma not receiving~     anti-inflammatory therapy.~      Methods: Randomized, double-blind, placebo-controlled study assessing the effect of salt room~     therapy on BHR, FeNO, spirometry and pediatric asthma quality of life questionnaire (PAQLQ).~     The treatment period lasted 7 weeks, 14 sessions with (treatment group) or without salt~     halogenerator.~   "
60702|NCT02772328|"~     The purpose of this study is to test an intervention designed to train persons who inject~     drugs (PWID) and are infected with hepatitis C (HCV) and HIV in communication skills to 1)~     promote new HCV treatment and care 2) risk reduction and 3) recruit their social network~     members for HIV and HCV testing and linkage to care.~   "
60703|NCT02772315|"~     The purpose of this study is to assess the validity and usefulness of omics signatures for~     improved identification and risk stratification of patients with endocrine hypertension and~     stratification of patients with primary hypertension.~   "
60730|NCT02771964|"~     This study will compare two commonly-used methods for assessing patient-reported quality of~     life. The first is to assess quality of life before surgery and again after surgery using the~     same validated scale (ie Veterans Rand 12). The second is simply to ask patients whether or~     not they think their post-operative quality of life is better, worse, or the same. The~     investigators hypothesize that the second method may be inaccurate due to cognitive bias.~   "
60704|NCT02772302|"~     The primary aims of this study are:~        1. To determine the feasibility of deploying mindBEAGLE, a portable, bedside EEG-based~          system, in the Intensive Care Unit in patients with disorders of consciousness (DOC) or~          locked-in syndrome (LIS);~        2. To determine if mindBEAGLE neurophysiologic markers of cognitive function correlate with~          bedside behavioral assessments of consciousness;~        3. To determine if mindBEAGLE neurophysiologic markers of cognitive function correlate with~          functional MRI (fMRI) and electroencephalography (EEG) biomarkers of consciousness;~        4. To determine if mindBEAGLE can serve as an assistive communication device for people~          with LIS.~   "
60705|NCT02772289|"~     The study is to investigate the efficacy and safety of perinatal tissue mesenchyme stem cells~     treatment on the appearance of a caesarean scar as compared to a similar untreated scar.~   "
60706|NCT02772276|"~     This study is a pilot, safety, and pharmacokinetic study of MB-102 versus iohexol and the use~     of the non-invasive optical renal function monitor (ORFM) device in normal and compromised~     renal function participants with different skin color types.~   "
60707|NCT02772263|"~     Older adults living in subsidized housing report poorer health. Their low income and age make~     it harder for them to use community services. Many older adults have heart disease and~     diabetes, which lead to frequent emergency calls and hospital admissions. To decrease the~     costs of treating heart disease and diabetes through emergency and hospitalization, improved~     screening and health education is needed. The Community Health Assessment Program through~     Emergency Medical Services (CHAP-EMS) program will take place in communal areas within~     housing buildings of older adults and deliver a heart disease, diabetes, and falls risk~     check-up with health education. This is expected to improve the health of older adults~     leading to fewer emergency calls and hospital visits.~      Paramedics on modified duties (e.g. injured) will conduct weekly, one-on-one drop-in sessions~     for seniors in a common area of one subsidized apartment building in Hamilton, Ontario.~   "
60708|NCT02772250|"~     The study compares the efficacy of bowel preparation between the face-to-face~     re-education(FFRE group) and normal education (no-FFRE group) in patients.~   "
60709|NCT02772237|"~     The purpose of this study is to investigate the effectiveness of riboflavin to decrease the~     duration of time for a student-athlete to return to participation in sports after a sports~     related concussion.~   "
60710|NCT02772224|"~     Comparing the efficacy and safety of drug-eluting balloons (DEB) for the treatment of~     below-the-knee peripheral arterial occlusive disease with conventional balloon angioplasty~     (BA).~   "
60711|NCT02772211|"~     This is a two-stage experiment; the first stage is an open label trial in which participants~     receive six intravenous (IV) treatments of ketamine. The second stage includes participants~     that responded to ketamine (i.e. reduction of 25% in their symptoms of depression, as~     measured by the Montgomery Asberg Depression Scale MADRS). The second stage is a~     double-blind, controlled clinical trial of D-cycloserine (DCS) vs. placebo, as maintenance~     treatment in patients who responded to ketamine treatment. The aim of the study is to~     determine whether 8 weeks of DCS maintenance therapy will prevent relapse of depressive~     symptoms following ketamine infusions~   "
60712|NCT02772198|"~     This phase 1 / 2 study will evaluate the response of B-cell malignancies expressing CD19 to~     autologous T cells transduced with a second generation anti-CD19 chimeric antigen receptor in~     children and young adults.~   "
60713|NCT02772185|"~     This study is a double blind, sham-controlled clinical trial aiming to compare the long-term~     effects of stimulation in Alzheimer's Disease (AD). Sixty early AD patients will take part in~     a phase II/III clinical study over a 1-year period. The study involves transcranial direct~     current stimulation (tDCS), cognitive training (CT), detailed neuropsychological and~     neurological testing. These assessments will occur at baseline, then again at two month (end~     point). Those who achieve clinical improvement with neurostimulation and cognitive therapy~     will be invited to receive treatment for 12 months as part of a follow-up study.~   "
60714|NCT02772172|"~     The main purpose of the present study is to evaluate the dental implant placement using two~     different CBCT-derived templates and to study the related factors that affect accuracy so as~     to support the further clinical application of the technique. Thirty patients with partial~     edentulous denture are recruited. They are randomized to two groups. A radiographic guide is~     prepared before CT/CBCT scan. The CT/CBCT scan DICOM ﬁles are loaded in a planning program~     and converted into 3D computer images. A surgical template is fabricated through this virtual~     planning. After 6 weeks, if the implants are judged stable, the patient has the option of~     replacing the ﬁxed prosthesis. Patients are recalled for oral hygiene maintenance and~     prosthetic controls every 6 months for the entire duration of the study.~   "
60715|NCT02772159|"~     The purpose of this study is to evaluate the absorption, distribution, metabolism and~     excretion of an investigational medication used to treat chronic obstructive pulmonary~     disease (COPD). The study drug will be tested in 6 healthy normal males. Dosing will include~     a single dose of study drug administered via an IV Infusion and an Oral Dose. There will be a~     28 day washout period between each of the 2 dosing routes.~   "
60716|NCT02772146|"~     A single-center, prospective, non-randomized, clinical and first-in-human study. Each patient~     will be studied during a single treatment session of ten hours. The device will be connected~     to an existing, standard PD catheter that the patient will be using routinely prior to the~     study (i.e. a peritoneal dialysis catheter will not be specifically inserted for the study).~     The patient will be hospitalized for observation during the test day and during the night~     following the study session. Ultrafiltration volume, dialysate glucose concentrations, blood~     glucose concentrations as well the patient's acceptability and tolerance of the wearable~     device will be evaluated.~   "
60717|NCT02772133|"~     Purpose: The purpose of this study is to evaluate the impact of acute ST-segment elevation~     myocardial infarction (STEMI) and primary percutaneous coronary intervention (PCI) on~     circulating prolylcarboxypeptidase (PRCP) level and activity.~   "
60718|NCT02772120|"~     The aim of this study is to test the hypothesis that the pregnancy rates of women (ages 18-50~     years) undergoing transfer of vitrified-warmed blastocysts (frozen at less than 41 years of~     age) as part of their IVF treatment are not different with respect to the administration of~     progesterone (Crinone® 8% vaginal gel versus intramuscular progesterone).~   "
60720|NCT02772094|"~     Purposes:~      The purpose of this phase-II clinical trial is to determine whether or not ADCTA-G, a~     biologic vaccine preparation of patient's own dendritic cell (DC) for glioblastoma~     multiforme (GBM) treatment, is safe and effective in extending the GBM patient's life. The~     current conventional multi-modal regimen that may include surgery for tumor resection or~     biopsy, temozolomide (TMZ) combined chemo-radiotherapy (CCRT) and TMZ adjuvant chemotherapy~     almost always leaves residual GBM cells to cause fatal recurrence, leading to medium survival~     period of 8 -15 months and over-all survival rates of about 30% in 2 years and <3% in 5 years~     after diagnosis/surgery. Thus, in neurosurgical oncology practice, GBM patients in the first~     2-year period during and after receiving multi-modal therapy are watched closely for possible~     GBM tumor recurrence and mortal disease relapse and immediately given palliative treatments~     and health care, until death. In this phase-II trial, GBM patient participants who receive~     ADCTA-G vaccine adjuvant immunotherapy (added to the conventional multi-modal regimen) will~     be similarly watched closely by treatments and health care visits at least biweekly from the~     date of surgery/diagnosis to 24 months, and if alive followed by weekly phone calls and~     scheduled health care visits at least once every 3 months, up to 72 months after surgery. In~     the trial protocol, ADCT-G in 10 doses is administered after surgery, over a period of 6 or 8~     months, as an adjuvant immunotherapy of the conventional multimodal regimen. Individual~     ADCTA-G vaccine lot of every participant GBM patient is manufactured from patient's own~     monocyte-derived dendritic cells and the patient's own tumor cell antigens, both of which are~     prepared by a distinct method of procedures performed within air particle-free barrier good~     laboratory practice (GLP) facility. Previous phase I/II clinical trial of ADCTA-G vaccine~     immunotherapy administered as an adjuvant to the conventional multimodal regimen, has~     obtained promising safety and efficacy results for GBM patients in a clinical center. This~     phase-II clinical trial in China Medical University Hospital-Taichung will employ essentially~     the same clinical protocols and the same distinct vaccine manufacturing method of standard~     operational procedures (SOP), that is, the conventional multimodal regimen plus adjuvant~     immunotherapy using personal ADCTA-G vaccine lot for every GBM patient participants.~   "
60721|NCT02772081|"~     This study will compare the administration of porcine surfactant (poractant alfa, Curosurf®)~     through a less invasive method (LISA) using a thin catheter (CHF 6440) during non-invasive~     ventilation (NIV) (CPAP, NIPPV, BiPAP) with an approved conventional surfactant~     administration during invasive ventilation and rapid extubation in terms of short term and~     mid-term safety and efficacy in spontaneously breathing preterm neonates with clinical signs~     of respiratory distress syndrome (RDS).~   "
60722|NCT02772068|"~     Heart failure with preserved ejection fraction or HFpEF, represents nearly 50% of all heart~     failure cases and is particularly common in the elderly. The disease has no current treatment~     options. Symptoms typically occur during exertion or exercise and is likely the result of~     increased cardiac and pulmonary congestion as a result of impaired diastolic function.~     Istaroxime is a novel activator of SERCA2a, an important regulator of calcium uptake within~     the myocyte. We will test the hypothesis that Istaroxime will improve diastolic function~     during exercise in HFpEF patients which in turn will reduce cardiac and pulmonary congestion.~   "
60723|NCT02772055|"~     This is a multicentre, randomised, single blinded, parallel-group design clinical trial to~     assess the effect of moxa smoke in the treatment using moxibustion for Knee Osteoarthritis.~   "
60724|NCT02772042|"~     Manual therapy reduces symptoms in patients with cervicogenic dizziness. The mobilization and~     manipulation of upper cervical spine are the most popular treatment in this patients. The~     International Federation of Orthopaedic Manipulative Physical Therapists suggest different~     recommendations for the safety application of manual therapy techniques in the upper cervical~     spine, traction manipulation techniques complies with this conditions. However, there isn´t~     investigation about the effect of traction manipulation in patients with cervicogenic~     dizziness. The aim of this study is to investigate the effects of traction manipulation in~     dizziness intensity, range of motion of cervical spine and quality of life on patients with~     cervicogenic dizziness.~   "
60725|NCT02772029|"~     Hepatocellular carcinoma (HCC) is one of the lethal human cancers worldwide and its incidence~     matches mortality, reflecting the poor prognosis of this disease. The surgical resection rate~     of HCC is low, and the prognosis is poor. Although transarterial chemoembolization (TACE) is~     the main treatment for HCC patients who are not candidates for surgical resection, it is not~     considered a curative procedure. For HCC, poor TACE efficacy or TACE failure may be related~     to tumor angiogenesis of the residual disease. Among the many regulatory factors in tumor~     angiogenesis, hypoxia-inducible factor-1α (HIF-1α) and vascular endothelial growth factor~     (VEGF) play vital roles in this process.~      Sorafenib is the first systemic treatment drug, which has been approved by the FDA for~     advanced HCC. In order to find an new VEGFR-inhibitor with better effect and lower toxicity,~     Jiangsu Hengrui Medicine Co., Ltd. developed Apatinib, a high-performance VEGFR-2 tyrosine~     kinase inhibitor. Apatinib plays anti angiogenic effect in the treatment of malignant tumor~     mainly through inhibition of VEGFR-2, in vivo and in vitro experiments showed good tumor~     growth inhibitory activity on glioma, this study aims to further verify the efficacy and~     safety of Apatinib for first-line treatment failure hepatocellular carcinoma patients, the~     primary endpoint is time to progression(TTP).~   "
60726|NCT02772016|"~     Seventy-two pregnant patients diagnosed of minor or intermediate beta thalassemia with mild~     anemia were randomly assigned to treatment group and control group. Patients in the treatment~     group were given 15 g of Colla corii asini in powder form daily for 4 weeks while the control~     group were observed and followed up in the same period without any treatments. Levels of~     hemoglobin(Hb), serum iron (SI), serum ferritin (SF) and three types of hemoglobin components~     [adult hemoglobin (HbA), fetal hemoglobin (HbF), minor adult hemoglobin (HbA2)] were measured~     before and after treatments.~   "
60727|NCT02772003|"~     This phase I trial studies the side effects and best dose of deoxyribonucleic acid (DNA)~     vaccine therapy in treating patients with hepatitis C virus (HCV) infection that persists or~     progresses over a long period of time. Vaccines made from DNA may help the body build an~     effective immune response to kill cancer cells that express HCV infection.~   "
60728|NCT02771990|"~     The goal of this study is to investigate the role of central neural pathways in mediating~     chronic pain. The aim of the study is to test the effect of stimulating brain regions that~     are part of a network underlying central pain processing using a non-invasive brain~     stimulation technique, transcranial Direct Current Stimulation (tDCS). Prior studies have~     used tDCS to target both sensory related cortical areas and those important for higher-order~     representations of pain. This study will target brain regions important for the behavioral~     response to the chronic sensation of pain. The hypothesis is that stimulation of these brain~     regions can modulate not only the affective component of pain, but ultimately also improve~     functioning and quality of life. This hypothesis will be tested by treating study~     participants eighteen and older with chronic low back pain (CLBP) of greater than six months~     using tDCS. To be part of this study, participants must meet all the inclusion and exclusion~     criteria.~   "
60729|NCT02771977|"~     In this trial, patients with acute kidney injury who have recently received a drug that may~     affect kidney function will be randomized to having an alert placed in the electronic health~     record or usual care.~   "
60732|NCT02771938|"~     Many women with breast cancer now live for decades after their breast cancer treatment. In~     view of this, modern breast reconstruction surgery after mastectomy for breast cancer aims to~     reproduce as natural a breast shape as possible. Keeping a natural breast appearance has been~     shown to be very important to a woman's emotional and psychological recovery.~      Breast cancer treatment often includes a combination of surgery, chemotherapy, radiotherapy,~     anticancer tablets such as Tamoxifen, and newer targeted drugs such as Herceptin.~     Radiotherapy is usually given after surgery. However, radiotherapy after mastectomy and~     breast reconstruction can damage the 'new' breast giving a less good breast shape and~     appearance in the longer term. Also, if recovery is slow following surgery, the radiotherapy~     is delayed which may reduce its effectiveness. Changing the order of treatments has been~     shown to be safe and effective for chemotherapy, Herceptin and anticancer tablets but we have~     very little information on giving radiotherapy before breast cancer surgery.~      The investigators want to find out if giving radiotherapy before mastectomy and~     reconstruction alters surgical complication rates and they want to evaluate the appearance of~     the reconstructed breast when radiotherapy is given before surgery.~   "
60733|NCT02771925|"~     Alcohol use disorders are present across medical specialties, with alcohol-related deaths~     particularly prevalent in the categories of injury, liver cirrhosis, cancer, cardiovascular~     disease, disorders of the peripheral nerves and of the central nervous system. Alcohol~     dependence, also referred to as alcohol use disorder, is a chronic, relapsing disorder marked~     by compulsive alcohol use, an inability to stop drinking despite harmful consequences, and~     the emergence of a withdrawal syndrome upon cessation of use. Early abstinence is associated~     with activation of brain stress systems in the extended amygdala. Clinically, protracted~     abstinence involves symptoms of craving, mood and sleep disturbance, all of which have been~     identified as risk factors for relapse. Nonetheless, implementation of alcohol-specific~     medications remains limited across most medical specialties. Medications for treating alcohol~     dependence primarily have been adjunctive interventions, and only three~     medications—disulfiram, naltrexone, and acamprosate—are approved for this indication by the~     United States Food and Drug Administration. Baclofen, an inhibitor of synaptic transmission~     through spinal reflex arcs via hyper polarization of primary afferent fiber terminals, was~     originally approved by the Food and Drug Administration in 1977 for use in spasticity~     associated with neurologic conditions, such as multiple sclerosis and spinal cord lesions.~     However, due to its pharmacologic properties it has also been investigated for the treatment~     of alcohol dependence. But in the clinical practice of study physicians, it was observed that~     most of the patients who were prescribed baclofen for alcohol dependence hit back to alcohol~     very soon despite being on the drug. Therefore there is a need to search for an alternative~     drug which could be beneficial for this population of patients. Gabapentin is Food and Drug~     Administration-approved for the management of epileptic seizures and neuropathic pain. It is~     believed to act by blocking a specific alpha-2d subunit of the voltage-gated calcium channel~     at selective presynaptic sites and, as a result, to indirectly modulate Gamma Butyric Acid~     neurotransmission. Pre-clinical findings indicate that gabapentin normalizes the~     stress-induced Gamma Butyric Acid activation in the amygdala that is associated with alcohol~     dependence, and provide an excellent pre-clinical rationale for evaluating gabapentin as a~     treatment for alcohol dependence. Earlier studies of gabapentin in alcohol dependent~     subjects, attempting to abstain following withdrawal support the safety and potential~     efficacy of gabapentin in alcohol dependent patients, but definitive conclusions were limited~     by either small sample size, methodological, or dosing issues.~   "
60734|NCT02771912|"~     Controversies exist about the use of propofol in sedation of patients for cataract surgery.~     This prospective randomised double-blind study evaluates the efficacy of patient-controlled~     sedation compared with placebo using the same device.~   "
60735|NCT02771899|"~     Adults (18 years and over) and children (10-17 years of age) scheduled for surgery to correct~     scoliosis will be included in this study, for which participation will last 6 months. Each~     age group of participants will be randomized to two cohorts: one cohort will receive standard~     of care, while the other will also have their standard radiographic images used in the~     construction of a three-dimensional visualization of the spine. Questionnaires administered~     before and after surgery, in addition to health information collected throughout the course~     of the study, will indicate whether the three-dimensional model has an effect on the~     planning, performance, and outcomes of surgery. Participants in this study will not be asked~     to do anything outside the standard of care. The only manipulated variable in this study is~     the construction of the three dimensional model, which is made from information collected~     during the standard of care, and requires no further action on the participant's behalf. The~     results of this study may show that three-dimensional visualizations can be of value to~     spinal surgeons, and positively affect patient outcomes.~   "
60736|NCT02771886|"~     The purpose of this study is to evaluate the effectiveness of a brief Surf the Urge~     intervention to reduce adolescent and young adult (i.e., 14 to 24 years old) urge-related~     behaviors. These behaviors will include, but not be limited to, substance use, deliberate~     self-harm, aggressive behavior, pulling out hair, and loosing control when eating.The~     intervention will utilize mindfulness skills (i.e., awareness, acceptance, nonjudgment) to~     assist in reducing these risky behaviors.~   "
60737|NCT02771873|"~     The overall goal of the study is to test the effectiveness and sustainability of an~     integrated care model for managing cardiovascular risk in individuals with family history of~     premature coronary heart disease (CHD).~      This care model involves:~        1. screening for cardiovascular risk factors,~        2. providing lifestyle interventions for prevention and management of cardiovascular risk~          factors,~        3. providing a framework for linkage to appropriate primary health care facility and~        4. active follow-up of intervention adherence.~      Initially, a formative qualitative research component will gather information on~     understanding of diseases, barriers to care, specific components of the intervention package~     (for example, context specific ways to enhance physical activity and to reduce prolonged~     sitting time, ways to improve diet etc.) and feedback on the intervention strategies~     (lifestyle education, care and linkage coordination). Then a randomized controlled trial~     involving ~700 families and 1400 participants will be used to determine whether an integrated~     care model is effective in reducing or halting the progression of CHD risk factors and risk~     factor clustering in families. The sustainability and scalability of this intervention will~     be assessed through economic and qualitative lenses to estimate value and acceptability.~     Scalability will be informed by cost-effectiveness and acceptability of the integrated~     cardiovascular risk reduction approach.~   "
60738|NCT02771860|"~     This is a randomized, double blind placebo controlled one-site proof-of-concept study in~     subjects with erosive osteoarthritis (OA) of interphalangeal (IP) finger joints.~      A total of 100 subjects will be enrolled into the study: 48 weeks placebo controlled~     double-blind phase with denosumab 60mg every 12 weeks, followed by a 48-week open-label phase~     in which all subjects will receive denosumab.~   "
60739|NCT02771847|"~     The pain associated with disorders of the masticatory system (DAM) include pain in the~     masticatory muscles, temporomandibular joints, or deux.1-5 In terms of frequency, the DAM is~     the second musculoskeletal disorder most common behind chronic pain in the dos.~      Pain associated with DAM not interested adults; they were also observed in adolescents (2-6%)~     7 with significant changes in their quality of life.8 The annual incidence of pain associated~     with DAM is 2.6% among adolescents and 3.9% for adults. 9 half to two-thirds of patients~     affected by DAM resorted to professional care, and one-third continued to be subjected to~     moderate pain and incapacity to severe, regardless of treatment given.~      Co-morbidities were identified in adults 12-14, children and adolescents with pain related to~     DAM, the United States and Suède. The most common painful co-morbidities among children and~     adolescents were headaches, neck, back, limbs or abdomen.~      The reasons for the co-existence of DAM with other painful conditions are not well~     understood. Nevertheless, it has been demonstrated in adults that they contributed to~     apparition and persistence DAM beyond healing time conventionally predicted; they increased~     deterioration state health and could complicate significantly the diagnosis and efficacy of~     treatment.~      Co-morbidity is defined as the simultaneous existence and the occur two or more diseases,~     medically diagnosed in the same person.~      The prevalence of several chronic painful conditions appears to be greater among people of~     low socioeconomic status compared with those of higher and higher socioeconomic status among~     women than hommes.~      head pain is commonly reported in the general population (46%) The headache prevalence ranges~     from 9% to 97% among adults and 30% to 94% among Adolescents with DAM.~      Women have a higher probability have pain related to DAM (odds ratio (OR) = 2.2, 95%~     confidence interval (CI): 2.1-2.4) or headache (OR = 2.5, 95% CI: 2.4-2.5) than men.~     Cross-sectional studies and case-control demonstrated that subjects with DAM-related pain~     were 1.5 to 8.8 times more likely to have headaches compared to those without pain associated~     with DAM.~      The relationship between headaches and DAM n`est unclear. Both conditions seem to share~     similar pathophysiological mechanisms that would promote the development of both diseases in~     a individual. Patients affected by headaches are more likely to develop a DAM? A cohort study~     showed that adolescents affected by headaches, the chance of developing pain related to DAM~     was 2.7 times (95% CI: 1.6-4.4) than adolescents without headaches. Conversely, the~     probability of having headache increases with the number of symptoms according to a~     relationship of DAM.~      Following the results of these studies cited before, it is now necessary to confirm the~     relationship between headaches and DAM among adolescents.~      Neck pain and back are symptoms commonly reported in adults with DAM (35% to 44%). 23 The~     adults affected by DAM have smaller mobility angles in the cervical and more sensitive points~     to trapezoids when compared to those without DAM.~      Cross-sectional studies and case-control have demonstrated that adult patients with~     DAM-related pain had 2.6 to 5 times more likely have back pain than individuals without pain~     related to DAM. Chances pain joint (OR = 4.0, 95% CI: 3.7-4.3) are larger among adults~     affected by DAM related pain compared to those indemnes. adults affected by DAM-related pain~     were also more likely to experience neck pain (OR = 4.0 to 7.9).~      Adult women affected by DAM-related pain are more likely to have pain in the neck (OR = 1.5;~     95% CI: 1.4-1.8) and back (OR = 1.2; 95% CI: 1.2-1.3) compared to hommes a prospective cohort~     study demonstrated that there was a greater likelihood of pain related to DAM among~     adolescents affected by back pain compared to those not affected (OR = 3.0, 95% CI: 2.2-6.8)~     Our study aims to seek more evidence on the supposed relationship between pain related to DAM~     and sore neck or back in the adolescent population.~      The irritable bowel syndrome (CIS; 9% to 16%), interstitial cystitis (17%), and stomach pain~     (34%) are rated among adults affected by DAM. Adults affected by DAM were 2.7 times (95% CI:~     1.4-5.1) more likely to have irritable bowel syndrome than subjects of the same age not~     affected. teenagers affected by DAM were 1.5 times (95% CI: 1.0- 2.1) over have luck stomach~     upset that the subjects of the same age unaffected.~   "
60740|NCT02771834|"~     The incidence of osteoporosis has been increasing, as have fractures resulting from falls.~   "
60741|NCT02771821|"~     Randomized clinical trial with the objective of evaluating the effectiveness of operative~     groups to promote healthy habits in elderlies diabetics. The study was conducted in the~     Family Health Units of Microregion 4.2 Sanitary District IV of Recife, Pernambuco, Northeast~     Brazil. Participated in 202 elderlies diabetic randomly assigned to two groups: intervention~     and control, with similar characteristics in relation to age. Data collection occurred from~     August 2014 to August 2015 and elderlies were followed for 6 months (T0 to T6). Control group~     participated in the routine individual consultation with the staff of the Family Health Unit~     on a quarterly basis. Intervention group participated the routine individual consultation~     with the staff of the Family Health Unit on a quarterly basi and six operative groups of~     health education, with monthly frequency and duration of two hours, using the methodology of~     problematization (FREIRE, 2011), with themes identified from the needs of the participants.~   "
60742|NCT02771808|"~     Specific aim 1a will test the hypothesis that diabetic patients with 2-2 haptoglobin genotype~     have higher indices of postoperative myocardial injury (creatine kinase MB isoenzyme ,~     Troponin I ) and renal injury (as indicated by elevated creatinine, cytostatin C and~     glomerular filtration rate). Of note, significantly elevated levels (>5 times the upper~     normal limit) of creatine kinase MB isoenzyme and troponins postoperatively have been~     associated with postoperative myocardial ischemia/infarction and are a predictor of~     short-term and long-term mortality after cardiac surgery.~      Specific aim 1b will evaluate preoperative and postoperative indices of oxidative stress~     (such as isoprostane f2 alpha and malondialdehyde) and will evaluate whether patients with~     type 2-2 haptoglobin express increased oxidative stress. The investigators will also try to~     correlate whether patients with increased oxidative stress are those with elevated indices of~     myocardial and/or renal injury Specific aim 1c will try to evaluate whether patients with~     type 2-2 haptoglobin also have increased levels of inflammatory indices (C-reactive~     protein,[interleukin] IL-1, IL-2, IL-6, TNF[tumor necrosis factor]) and try to correlate the~     findings with postoperative myocardial and or renal injury.~      The incidence of atrial fibrillation after coronary artery bypass graft ranges from 19% to~     27%. The investigators will also look at any correlation of the type 2-2 haptoglobin and the~     incidence of post-operative atrial fibrillation.~   "
60743|NCT02771795|"~     A Long-term Follow-up Study for Cardiac Safety in the Patients with HER2 Positive Early or~     Locally Advanced Breast Cancer Who Have Completed the SB3-G31-BC~   "
60744|NCT02771782|"~     This study has three purposes:~      To investigate whether the immune response to pertussis is increased when TDaP-IPV is given~     together with BCG vaccine, compared to when it is given alone.~      To investigate whether BCG vaccination modulates the immune response to non vaccine target~     antigens (i.e., antigens/pathogens not used in the vaccine itself).~      To investigate whether TDaP-IPV vaccination modulates the immune response to non vaccine~     target antigens.~   "
60745|NCT02771769|"~     This is a multi-centre prospective study in which blood samples will be taken from 1500 male~     patients aged between 21-80 scheduled for prostate biopsy. Analysis of cell-free cancer DNA~     extracted from these samples will be undertaken to determine whether copy number instability~     scores derived from the cfDNA correlates with PSA screening levels and prostate biopsy~     results (i.e. Gleason score) in these patients.~   "
60746|NCT02771756|"~     The purpose of this study is to research more reasonable and safe methods of nutritional~     support to improve the nutritional status of tumor patients, which guarantees the anti-tumor~     treatment such as chemotherapy.~   "
60747|NCT02771743|"~     The purpose of this study is to improve outcome of high risk neuroblastoma by tailoring the~     treatment intensity of tandem high dose chemotherapy according to the treatment response to~     induction chemotherapy.~   "
60748|NCT02771730|"~     The purpose of this study is to test experimental human immunodeficiency virus (HIV) vaccines~     that use an adenovirus vector. The adenovirus vector may help the vaccines stimulate an~     immune response. Researchers want to see how the immune system will respond to these vaccines~     as well as if they are safe to give to people. Participants cannot get HIV from these~     vaccines. However, researchers also want to see if the vaccine's adenovirus is contagious.~     Adenoviruses cause cold symptoms or mild eye infections, therefore household and intimate~     contacts will be asked to participate as well.~   "
60749|NCT02771717|"~     The purpose of this study is to determine whether a low exhaled nitric oxide reading (<27ppb)~     is a good predictor of a negative response to inhaled steroid treatment for patients with~     symptoms suggestive of asthma.~   "
60750|NCT02771704|"~     Dental caries is an infectious disease mediated by a consortium of microbes in the oral~     cavity. The disease is characterized by demineralization of the tooth, if untreated, it leads~     to cavitation, discomfort, pain and eventual tooth loss. Frequently, complete caries removal~     of dentine carious lesions leads to exposure of the pulp affecting its vitality. Therefore,~     it is crucial that vitality of the teeth is preserved causing little damage to the pulp.~     Different approaches have been used to reduce or eliminate microorganisms underneath the~     restorations. Chlorhexidine has a strong antibacterial effect, particularly on planktonic~     bacteria. Its effect on bacterial biofilms is compromised, however The objective of this~     study is to examine the in vivo effect of diamine silver fluoride, potassium iodide and their~     mixture on bacteria present in deep carious lesions. Dentine samples from 5 carious lesions~     from each of 5 patients before and after treatment with test agents will be collected in~     pre-reduced sterile Ringer's solution and processed for microbiological evaluation. The~     samples after serial dilution and plating will be incubated in aerobic, anaerobic and CO2~     atmosphere for 2-5 days. Colony forming units will be enumerated and the effect of~     antibacterial agents in question on the bacterial viability in carious lesions will be~     assessed.~   "
60751|NCT02771691|"~     This is a prospective parallel group design of group-based Mentalization-Based Therapy for~     Adolescents (MBT-A) through a pilot randomised controlled trial comparing group-based MBT-A~     plus treatment as usual (TAU) to TAU alone. As a pilot study, we aim to determine: the~     effectiveness of our recruitment strategies; compliance with protocol/procedures; trends~     towards reduced self-harm.~   "
60752|NCT02771678|"~     The aim of this project is to estimate the quality of life for people with asthma and~     specifically the loss in quality of life associated with an asthma-related crisis event~     (accident and emergency (A&E) attendance or admission).~   "
60754|NCT02771652|"~     In this randomised controlled trial, the feasibility and effectiveness of an internet-based~     exercise intervention including progressive strength and endurance training (e-training) for~     PwMS was investigated. Primary outcome was health-related quality of life, secondary outcomes~     were muscle strength, aerobic capacity and lung function, physical activity and fatigue.~   "
60755|NCT02771639|"~     Introduction Periprosthetic joint infection (PJI) is a severe complication to hip~     arthroplasty for femoral neck fractures (FNF). Debridement, antibiotics and implant retention~     (DAIR) is recommended in early PJI in association with stable implants. Few studies have~     evaluated the outcome of DAIR in this fragile population.The purpose of this study was to~     analyze risk factors for PJI and the short-term outcome of DAIR in FNF patients treated with~     a hip arthroplasty.~      Methods A consecutive series of patients had been treated with either a total hip~     arthroplasty or a hemi hip arthroplasty for a displaced FNF at our institution. Data were~     retrospective analysed.~   "
60756|NCT02771626|"~     This study is an open-label Phase 1/ 2 evaluation of CB-839 in combination with nivolumab in~     patients with clear cell renal cell carcinoma, melanoma, and non-small cell lung cancer.~   "
60757|NCT02771613|"~     After implementing a French version of a trigger tool validated for computerized detection of~     adverse events in patient's medical record, the study will be performed in three parallel~     randomized arms of three identical departments (each steaming from 6 types of medical,~     surgical or obstetrical departments with a total of 18 departments involved). This three arms~     will be: no intervention, education of department's staff by multi professional in situ~     simulation (adapted to the discovered adverse events), or simple but large diffusion of~     results and decisions of Morbidity Mortality Reviews.~      The interventions will be performed during a two-years period.~   "
60758|NCT02771600|"~     Needle-related procedures are the most important source of pain and anxiety in pediatric~     patients. Consequently, needle-phobia and anxiety are common in children with auto-immune~     disease and immune deficiency and may be barriers to adherence in treatment. The use of a~     non-pharmacological and easy-to-use approach, like the Buzzy® device, could be an alternative~     or adjuvant for the management of procedural pain and anxiety of these children during~     needle-related procedures.~      This study aims to determine the feasibility, acceptability and satisfaction of the Buzzy®~     device for procedural pain and anxiety relief of immunology-rheumatology patients undergoing~     needle-related procedures. The investigators will compare the Buzzy® device with an~     anaesthetic cream (Maxilene®) during needle-related procedures. The investigators also plan~     to assess feasibility outcomes and satisfaction of the nurses and the children with the use~     of the Buzzy® device. This pilot study should refine or modify the research methodology and~     improve the intervention being piloted before it's efficacy will be verified within a larger~     scale-study.~      The investigators strongly believe that the use of the Buzzy® device in immunology~     rheumatology department could optimise procedural pain and anxiety management. Since most of~     the treatments administered for auto-immune diseases and immune deficiency diseases are~     through subcutaneous or intramuscular injections, pain and anxiety management using~     non-pharmacological and/or pharmacological interventions should be prioritized. Given this~     knowledge, the investigators feel that this pilot study has the potential to contribute to~     pain and anxiety management of children undergoing needle-related procedures.~   "
60759|NCT02771587|"~     The main objective of the project is to assess whether there is an interaction between the~     effects of ethanol and energy drinks on driving performance.~      Secondary objectives include: to evaluate subjective effects (drunkenness) after~     administration of alcohol and energy drinks, to assess pharmacokinetics of alcohol, caffeine~     and taurine after alcohol and energy drinks administration and to assess if there is an~     increased risk of bleeding when both drinks are taken together.~   "
60760|NCT02771574|"~     This study is designed to evaluate the efficacy, safety and pharmacokinetics of subcutaneous~     exendin (9-39) in subjects with post-bariatric hypoglycemia. Development of this subcutaneous~     formulation of exendin (9-39) would represent a targeted therapeutic approach for this rare~     disease with unmet clinical need.~   "
60761|NCT02771561|"~     Obstructive sleep apnoea (OSA) is a condition which involves episodes of interrupted~     breathing during sleep due to repetitive narrowing or collapse of the throat. These episodes~     are usually associated with a drop in blood oxygen levels and brief awakenings, which disrupt~     the sleep of those affected and can lead to daytime sleepiness. OSA is associated with an~     increased risk of heart disease and stroke.~      In some individuals, the low oxygen levels in the blood can be made worse by also having a~     small hole in the heart, called a patent foramen ovale (PFO). This hole is present at birth~     in everyone, but in some people (about 30% of the normal population) it fails to close.~     Usually a PFO does not cause any medical problems. However, it may be recommended to have a~     PFO closed by key-hole surgery if someone suffers a stroke, severe migraine or if they are~     professional divers. There is a higher incidence of PFO in patients with OSA (25-50%)~     compared to the wider population and this may account for some of the observed increased risk~     of heart disease and stroke in patients with OSA.~      This study will assess the number of patients with OSA who also have a PFO, and whether~     closing the PFO can improve the symptoms of OSA (e.g. sleepiness, exercise capacity and~     general well-being), thereby enabling the patient to not be reliant on treatment for OSA. If~     the study shows that closing the PFO is beneficial then the investigators will assess in a~     larger study if this treatment can also reduce heart disease and strokes.~   "
60762|NCT02771548|"~     Background~      Anterior cruciate ligament (ACL) injuries are one of the most common sporting injuries of the~     knee. ACL reconstruction (ACLR) has become one of the most common surgical procedures in an~     attempt to increase joint stability and facilitate athletes to return to sport (RTS).~     Although ACLR is considered a relatively successful procedure, dynamic control risk factors~     and strength and power deficits in the involved limb are still present after patients return~     to sport.~      Dynamic multi-plane, multi-joint actions such as jumping, landing, change of direction~     cutting, have been shown to be common mechanisms of injury for the ACL in field sports .~     Returning to multidirectional sports requires a proficiency and efficiency of movement when~     carrying out these tasks. There is a lack of standardized, objective criteria to accurately~     assess an athlete's ability to safely RTS. Therefore, there is a need for research that~     simultaneously analyses sport specific dynamic tasks (3D motion analysis) and muscular~     strength/power deficits that may explain poor outcomes following ACLR. This study aims to~     further investigate movement patterns, limb asymmetry and muscle strength deficit in patients~     post-surgery to identify risk factors for re-injury and criteria for RTS.~      The purpose of this study was to:~        1. Analyse kinematic (movement descriptors) and kinetic (forces that cause movement) during~          sports specific dynamic tasks at different time-points (6 and 9 months) following ACLR.~        2. To explore the association of those findings with those who re-injure, those who have~          persistent knee pain or with those who fail to return to sport.~        3. To compare the ACLR participants with age and gender matched healthy multidirectional~          athletes.~      It is hypothesised that biomechanical analysis will identify clear risk factors for poor~     outcomes following ACLR. Analysis of ACLR athletes' biomechanics during sports specific tasks~     will aid in the identification of athletes who are not yet ready to return to sport and will~     inform the clinician of what must be targeted in specific rehabilitation protocols before~     return to sport is considered.~      Brief protocol~      Participants will be recruited from patients who are scheduled to undergo anterior cruciate~     ligament reconstruction at the Sports Surgery Clinic, Ireland. Healthy participants will be~     recruited from local multidirectional teams. Participation will be voluntary and after~     obtaining informed consent patients will be asked to complete pre-operative questionnaires to~     ascertain injury information, and the function of their knee. During surgery the surgeon will~     fill out an intra-operative questionnaire. Items recorded will include graft type, laxity,~     involvement of other ligamentous structures, type of femoral and tibial fixation, meniscal or~     chondral pathology.~      Biomechanical assessment takes place at 6 and 9 months post surgery for the ACL group while~     the healthy participants will be tested on one occasion. The 3D testing session will include~     capturing of jumping, landing, hopping and cutting mechanics through the use of three~     dimensional motion capture technology and force plates. Here reflective markers are placed on~     the skin at anatomical landmarks. These markers are picked up by the infrared cameras and~     tracked at 200 frames per second. Participants will make contact with a force plate with~     their foot on undertaking the movements. Force and marker data will be combined to calculate~     joint angles and moments. Participants will also perform a muscle strength test using~     equipment called an isokinetic dynamometer. Both the operated and non-operated limbs will be~     tested.~      Participants will also be asked to fill out validated questionnaires to monitor self reported~     knee function, their confidence in their knee and also collect data on any continuing adverse~     symptoms such as locking, giving way, swelling or pain. Participants will also be asked if~     and when they return to sport. Questionnaires will be administered to participants at pre-op,~     3, 6, 9, 12 and 24 months post operatively.~   "
60763|NCT02771535|"~     Aim of the current study is to investigate the long-term efficacy of Metacognitive Training~     for Depression (D-MCT) and to explore whether previously observed effects at the 6-month~     follow-up of a randomized, controlled, assessor-blind, parallel group trial are maintained at~     the 3-year follow-up.~   "
60796|NCT02771093|"~     This is a multi-center, randomized, open-label, parallel-group comparative, exploratory study~     to evaluate the effect of trelagliptin administered at a dose of 100 mg once weekly or~     alogliptin administered at a dose of 25 mg once daily for 4 weeks on glycemic variation in~     patients with type 2 diabetes mellitus using continuous glucose monitoring (CGM).~   "
60797|NCT02771080|"~     This is a retrospective observational study to assess the relationship between peak systolic~     global longitudinal strain measured on pre-cardiopulmonary bypass trans-esophageal echo~     images predicts post-operative low cardiac output syndrome defined as the need for an~     inotropic support during 24 hours or longer.~   "
60764|NCT02771522|"~     This is a prospective, single-centre clinical study to monitor caries lesion activity in~     orthodontic patients with the Calcivis System over a 12 week period. Dentists will identify~     patients who have had dental appliances in place for a minimum of 12 months and have visible~     white spot lesions on the anterior surfaces of incisors and / or canines at de-bond.~     Following de-bond, images of the tooth surface will be taken with the Calcivis System.~     Presence or absence of elevated luminescence on the images will indicate activity /~     inactivity. Only patients with at least one tooth identified as active with the Calcivis~     System will continue in the study and be followed up at 2, 4, 8 and 12 weeks de-bond. Images~     of the active teeth will be taken with the Calcivis System as before, at each follow-up~     visit.~      The percentage of teeth showing luminescence using the Calcivis System will be calculated and~     summarised for all subjects for each post-baseline visit, and additionally by Investigator~     and ICDAS score at Visit 1. For each subject the percentage of teeth with each ICDAS score~     will be calculated. This will then be summarised over all subjects for each post-baseline~     visit and the ICDAS score will also be cross-tabulated with the presence/absence of~     luminescence from individual teeth for each visit.~   "
60765|NCT02771509|"~     The objective of the study is to assess the safety and efficacy of BB3 in preventing AKI~     compared to placebo when administered to patients at risk for developing acute kidney injury~     (AKI) following cardiac surgical procedures involving cardiopulmonary bypass (CPB).~   "
60766|NCT02771496|"~     The Cohort is a multi-site prospective data collection study that will enroll any patient~     with diagnosis of knee OCD (confirmed by a standard of care x-ray or MRI). Patients will be~     followed for up to the next 50 years of their lives to study courses of care, disease~     progression, treatment/surgical options/results, and specific sports-related outcomes in~     athletic patients. Subjects will complete quality of life surveys as part of the Cohort.~     Course of care will not be affected.~   "
60767|NCT02771483|"~     Giant cell arteritis (GCA) is a medium to large vessel vasculitis with a predilection for the~     superficial cranial and intrathoracic arteries. Diagnosing the condition and predicting which~     patients will develop large vessel complications remains a challenge. There are limitations~     with temporal artery biopsy, magnetic resonance angiography and ultrasound of temporal~     arteries and American College of Rheumatology classification criteria.~      Positron emission tomography (PET) has been shown to be a useful modality in detecting~     inflammation in large intra-thoracic vessels but previously has not been able to accurately~     detect FDG uptake in the superficial cranial arteries due to poor spatial resolution. Newer~     scanners can perform finer cuts of the head and can detect uptake in these arteries.~      This study has three main components:~        1. Cross sectional study assessing the accuracy of PET uptake in the superficial cranial~          and intrathoracic arteries of suspected GCA patients for the diagnosis of GCA~        2. Cohort study assessing the prognostic implication of FDG aortic uptake on aortic~          diameter at 24 months~        3. Cohort study assessing the Th1 and Th17 cytokine profile in patients with and without~          FDG PET uptake at 0, 6 and 24 months~   "
60768|NCT02771470|"~     Probiotics modulate the gut microflora and immune status in lung cancer who need~     chemotherapy.~   "
60769|NCT02771457|"~     The primary purpose of the project is to determine what is the best schedule for restarting~     infliximab in patients with inflammatory bowel disease (IBD) specifically ulcerative colitis~     and Crohn's disease, who have undergone infliximab infusions before. The primary endpoint~     would be the failure rate; the need to discontinue infliximab or change treatment. A~     secondary aim will be to determine if infliximab drug and antibody levels can predict~     clinical outcomes at 1 year. Other secondary outcomes include comparing short-term and~     long-term steroid free remission rate, and serum and fecal inflammatory markers in response~     to infliximab.~   "
60770|NCT02771444|"~     This study aims to evaluate image quality of a low-dose tomosynthesis system versus a~     comparator. Subjects will undergo a four-view tomosynthesis examination with the comparator~     and with the study device, and images will be assessed by several radiologists by comparing~     details in the images from the two systems.~   "
60771|NCT02771431|"~     Our study would be the first randomized study investigating the use of video conferencing via~     tablet computers versus traditional bedside rounding and its effect on clinical data such as~     length of stay and complications as well as patient satisfaction. As technology improves,~     medicine has an obligation to incorporate this technology to improve efficiency and~     cost-effectiveness. If telerounding is proven to not change outcomes or patient satisfaction,~     it saves time for the physician during office hours to see more patients or be productive in~     other ways. Telerounding could be applied in remote areas with a dearth of specialists,~     allowing these specialists' expertise to reach areas it could not before.~   "
60772|NCT02771418|"~     Volatile anesthetics interfere with cerebral blood flow and reperfusion-ischemia injury via~     the mechanism known as a preconditioning. A transient deterioration of local hemodynamics and~     oxygenation during carotid endarterectomy (CEE) might involve both hemispheres of brain and~     affect postoperative cognitive function. The goal of this study was to assess the effects of~     anesthetics on perioperative cerebral oxygenation and cognitive functions.~   "
60773|NCT02771405|"~     The study will recruit 150 patients with HCV related HCC ,after HCC treatment the patients~     will undergo treatment with different regimens of DAAs.~   "
60784|NCT02771262|"~     Dyspnea, or uncomfortable labored breathing, is an important patient-reported outcome (PRO).~     It is the primary and most disabling symptom of chronic obstructive pulmonary disease (COPD).~     There is a high priority to improve dyspnea PRO assessment and predict exacerbations.~     Frequent exacerbations are associated with increased disability, decreased quality of life~     (QOL), and accelerated lung function decline.~      Goals: To test the relative sensitivity to change, responsiveness and predictive validity of~     a comprehensive dyspnea outcome computer adaptive test (CAT) that measures new anxiety and~     activity avoidance domains and is more efficient to administer than existing dyspnea scales.~      Expected Outcomes: Investigators expect to:~        1. begin to transform how dyspnea is assessed;~        2. improve dyspnea symptom management;~        3. impact functional status;~        4. improve QOL;~        5. facilitate the earlier treatment and prevention of exacerbations;~        6. improve COPD prognosis and survival; and~        7. improve COPD healthcare utilization.~   "
60798|NCT02771067|"~     The purpose of this study is to investigate the validity of pulse pressure variation to~     predict fluid responsiveness in patients undergoing robotic or laparoscopic gastrectomy.~   "
60774|NCT02771392|"~     Corneal abrasion (CA) is one of the most common eye injuries, accounting for 10% of~     eye-related emergency visits.1 A 1985 survey showed that around 3% of all visits to US~     general practitioners were for corneal abrasions. In addition, in 2008, approximately 27,450~     work-related eye injuries and illnesses occurred that caused missed time from work.1Due to~     the large number of nerve endings even small corneal injuries can produce significant pain.~     The discomfort is typically most pronounced in the first 24-48 hours, and in many cases~     showed a loss in time at work and disruption of daily activities. The current standard of~     care in the emergency department includes topical analgesia and antibiotics with a change to~     oral analgesics upon discharge. Despite the ineffectiveness of oral analgesics in treating CA~     pain, most physicians do not prescribe topical analgesics based on standard medical teaching.~     The study's aim is to further investigate the role of tetracaine in the outpatient management~     of CA utilizing models already established to ensure safety. To accomplish this investigators~     will employ a prospective, double blind, randomized control model to compare undiluted 1%~     tetracaine hydrochloride to normal saline in patients presenting to the ED with uncomplicated~     corneal abrasions. Tetracaine will be supplied in three plastic prefilled, commercially~     available vials, each containing 0.5 mL of preservative-free, undiluted 1% tetracaine~     hydrochloride (a total of 1.5 mL or approximately 50 drops will be provide to avoid overuse).~     Saline will also be supplied in three plastic prefilled, commercially available vials,~     plastic bullets. Follow up visits or calls will be provide at 48 hour to reevaluate symptoms~     an asses the patients perceived pain using VAS provided in participant introduction packet~     during the informed consent process.~   "
60775|NCT02771379|"~     This study is a multicentre, prospective, non-interventional post-authorisation safety study~     (PASS) of the clinical outcomes for patients with LHON treated with Raxone®.~      No medication will be provided as part of this study. Raxone® will be obtained through~     commercial channels.~   "
60776|NCT02771366|"~     Cerebral energy metabolism declines with advanced aging, and is implicated in age-related~     cognitive decline, Alzheimer's disease (AD), and other forms of neurodegenerative disease~     (Parkinson's disease). In addition, age-associated increase in systemic and neuroinflammation~     is associated with a higher likelihood for development of Alzheimer's disease and~     neurodegenerative disease in older adults. Furthermore, decreased cerebral energy metabolism~     and increased neuroinflammation are both associated with deficits in cognitive function, even~     in the absence of neurodegenerative disease. In older adults, decreased cognition is strongly~     associated with the development of AD, increased rates of hospitalization, loss of functional~     independence, and increased mortality rate. Novel methods for preventing cognitive decline~     and neurodegenerative diseases in older adults are needed the world's aging population.~      Current research suggests that nutrients in fruits and vegetables produce strong anti-oxidant~     and anti-proliferative effects. Most Americans are not consuming the minimum recommendations~     of fruits and vegetables per day to receive these benefits. Whole food-based nutritional~     products, such as Fermented Papaya Product (FPP), may provide a healthy alternative for~     individuals. FPP, which is made by bio-fermentation of Carica papaya, has been found to~     enhance antioxidant protection and to decrease DNA damage in healthy older adults.~     Furthermore, if FPP increases cerebral energy metabolism and down-regulates~     neuroinflammation, with resulting effects on cognition, dietary supplementation with FPP may~     have preventative benefits for age-related cognitive conditions, including MCI, AD,~     Parkinson's disease and other neurodegenerative diseases.~   "
60777|NCT02771353|"~     This study aims to compare the resource impact, acute toxicity and feasibility of different~     pan-lymph node radiotherapy techniques. Radiotherapy using wide tangents with the patient in~     breath hold will be compared against volumetric modulated arc therapy (VMAT) in free~     breathing in the main trial. A parallel study will asses the accuracy of VMAT treatments~     using voluntary deep inspiratory breath hold compared to an active breathing controlled~     breath hold device.~   "
60778|NCT02771340|"~     The purpose of this study is to evaluate the safety, tolerability, biological activity,~     pharmacokinetics and pharmacodynamic activity of single and repeated escalating intravitreal~     doses of ICON-1 in patients with primary uveal melanoma who are planned to undergo~     enucleation or brachytherapy of the affected eye.~   "
60779|NCT02771327|"~     Evaluation of efficacy and safety from 6hours of 7 cmH2O CPAP after weaning in patients~     undergoing lung resection, on the prevention of atelectasis / pneumonia and gas exchange~     improve.~   "
60780|NCT02771314|"~     Based on the possibilities that both plasma and circulating tumor cells (CTCs) (the liquid~     biopsy) may offer, we consider that it could be feasible to longitudinally monitor the~     genetic evolution and the biologic characteristics of CTCs, by using Circulating tumor DNA~     (ctDNA) and CTCs as a source of biologic material. This approach could provide information~     regarding the genetic/molecular changes associated with primary and acquired resistance to~     AZD9291 and, thus, to facilitate to more appropriately adapt the tailored treatment in this~     particular group of NSCLC patients. It has been recently reported that the detection of~     resistant clones, based on the tumor-associated genetic aberrations in the blood, can~     identify treatment resistance up to 10 months earlier than the radiological methods~     providing, thus, the potential for an early switch to a non cross-resistant therapy in order~     to improve patients' outcome.~   "
60781|NCT02771301|"~     This trial is aimed at evaluating the safety and efficacy of IDH1R132H-DC vaccine in glioma~     with IDH1R132H mutation.~   "
60782|NCT02771288|"~     To investigate the safety and long-term vascular remodeling after bioresorbable vascular~     scaffold (BVS) implantation for stenotic or occluded lesion in children or young adults with~     Kawasaki disease (KD).~      Background: KD occurs worldwide, most prevalent in Japan and East Asian countries. Coronary~     artery lesion is the predominant determinant of KD outcome in the long-term. Children with KD~     with aneurysms at least 6 mm in maximal diameter had a greater than 50% chance of developing~     a clinically significant stenotic lesion during follow-up. They are at risk of myocardial~     infarction-related sudden death or congestive heart failure as young adults. Bypass surgery~     could be the reasonable strategy but the long-term patency of the graft remains~     unsatisfactory. Percutaneous angioplasty with drug-eluting stents (DES) implantation is the~     alternative. However, metallic stenting remains problematic in several aspects mainly due to~     the restriction of vessel expansive remodeling. The novel BVS has the potential to be free~     from the limitation due to scaffold degradation.~   "
60785|NCT02771249|"~     People with human immunodeficiency virus (HIV) often take several medicines to control HIV.~     Dolutegravir and darunavir boosted with cobicistat are HIV medicines that people may take.~     They may also need to take medicines for an infection called latent tuberculosis (TB).~     Researchers think a once-weekly treatment for latent TB would be easier for people with HIV~     to take. This once weekly treatment consists of two drugs: rifapentine and isoniazid.~     However, they need to see how TB drugs and HIV drugs interact.~      Objective:~      To learn how anti-HIV and anti-TB drugs affect each other so that people taking these drugs~     together can be treated safely.~      Eligibility:~      Healthy adults ages 18 65.~      Design:~      Participants will be screened with a medical history and physical exam. They will have vital~     signs taken and give a blood sample. Women will have a pregnancy test.~      Participants cannot take any other medicines during the study, including vitamins. Only~     occasional, infrequent use of acetaminophen (Tylenol , max 2000 mg/day), ibuprofen (Motrin or~     Advil ), naproxen (Aleve ), loperamide (Imodium ), and/or antihistamines (such as Benadryl ,~     Zyrtec , Claritin , etc.) will be allowed.~      Participants will be assigned to one of three groups. Each group will take a different study~     drug, once or twice a day, for 19 23 days. At the baseline study visit, they will get a~     supply of the study drug tablets and instructions for taking them. Participants will keep a~     medicine diary to serve as a memory aid for taking medicine and reporting any side effects~     that they may experience.~      Participants will have 8 or 9 study visits over about 40 days. The number of visits depends~     on which group the person is assigned to. All visits will take place at the NIH Clinical~     Center. Participants will fast before study visits.~      The baseline visit will last about 2 3 hours. There will be 3-4 long visits that will last~     for about 12 hours. The other 4-5 visits will last about 1 hour.~      During all study visits, screening procedures will be repeated. During long visits, an~     intravenous (IV) line will be inserted into an arm vein with a needle. It will be used to~     take blood.~   "
60786|NCT02771236|"~     Background:~      Genes are the basic units of heredity. When genes are changed, certain cells don t work like~     they should. Researchers want to try to better understand the genetic conditions that are~     linked with inherited eye diseases.~      Objective:~      To try to identify the genes linked to the development of inherited eye diseases.~      Eligibility:~      People ages 4 and older who have or have a family member with an inherited eye disease~      Design:~      Participants will be screened with medical history and medical records.~      Participants will have one visit that will take 3 4 hours. This will include:~      Medical and family history~      Eye exam: This includes the pupil being dilated.~      Electroretinography: A small electrode is taped to the forehead. Participants sit in the~      dark with their eyes patched for 30 minutes. Then numbing drops and contact lenses are put in~      the eyes. They will watch flashing lights.~      Blood tests~      Saliva sample: They will spit into a container or have the inside of their cheek swabbed.~      Genetic testing will be done on participants blood or saliva.~      Participants may meet with the researchers to discuss their genetic tests.~   "
60787|NCT02771223|"~     Prolonged extracorporeal circulation (ECC) for cardiac surgery results in coagulation~     abnormalities, most of which related to the direct, time dependent effect of the polymer~     tubing and the pump rollers on the thrombocytes. Significant evidence demonstrates the effect~     of the duration of cardiopulmonary bypass on thrombocytes number and function, as well as on~     postoperative coagulopathy~   "
60788|NCT02771210|"~     The purpose of this study is to demonstrate efficacy, including effects on inflammation by~     magnetic resonance imaging (MRI) assessments, of secukinumab on Achilles tendon enthesitis~     for up to 1 year with a primary focus at Week 24, in patients with active Psoriatic Arthritis~     and axial Spondyloarthritis despite current or previous non-steroidal anti-inflammatory drugs~     (NSAID) and/or disease modifying anti-rheumatic drug (DMARD) and/or anti-TNFα therapy.~   "
60789|NCT02771197|"~     AML is the most common acute leukemia in adults. Most patients can undergo allogeneic stem~     cell transplantation as a possible cure; however, many patients are not candidates for~     allogeneic transplant due to age, overall health, psychosocial factors, and/or lack of~     available donors. Therefore, these patients are unable to receive the therapeutic benefits of~     the graft-versus-leukemia effect of donor immune cells. The aim of this study is to~     hopefully break immune tolerance to AML cells to provide better outcomes in patients with~     non-favorable risk AML.~   "
60790|NCT02771184|"~     This clinical trial is conducted within the research project 'Computerized Lung Sound~     Analysis'. The research goal is the development of a system enabling the automatic~     classification of lung sounds, which will result in a decision support system for physicians.~      The objective of this trial is to create a small lung sound corpus, enabling the development~     of a prototype of the described system. Therefore, investigators record lung sounds with~     several lung sound transducers distributed on the posterior chest of human test subjects.~   "
60791|NCT02771171|"~     CT and MRI based measurements of the pediatric airway has changed the age-old cone shape~     concept of the pediatric airway and define airway shape as elliptical structure. The cone~     shape was based on the cadaveric measurements done by Bayeux in 1897 and described later by~     Eckenhoff in 1951.~      The present study is based on three-dimensional CT images of the airway column replicating~     the cylinders used by Bayeux for his cadaveric measurements. The purpose of this study was to~     determine the cone shape of the pediatric airway.~   "
60792|NCT02771158|"~     The purpose of this study is to determine whether midodrine administration decreases duration~     of intravenous vasopressors and intensive care unit length of stay for patients in septic~     shock.~   "
60793|NCT02771145|"~     The purpose of this study is to evaluate the safety and efficacy of FID 120947A in soft~     contact lens wearers of Japanese ethnicity. This study will be conducted in Japan.~   "
60794|NCT02771132|"~     The primary objective of this study is to compare the effectiveness of classroom-based~     behavioral interventions (12-hour girls program and 12-hour boys program), to a standard-of~     care intervention, on reducing the incidence of self-reported sexual assault among girls from~     baseline.~      Secondary objectives of this study is to determine the impact of the interventions on related~     physical and mental health status/outcomes, STI-risk behaviors, self-efficacy, and~     self-esteem.~   "
60795|NCT02771106|"~     Mild TBI subjects will initially be identified by providers in the Hennepin County Medical~     Center (HCMC) TBI Clinic. The subjects will then undergo objective testing by the~     developmental optometrist to confirm if they do or do not have vision dysfunction related to~     the mTBI. At the Center of Magnetic Resonance Research (CMRR) located at the University of~     Minnesota (U of M), the whole brain will be imaged using resting state and task functional~     MRI and diffuse tensor imaging (DTI) using a high field 3 Tesla (T) MRI. The subjects will~     then receive neurovision rehabilitation if they are in the vision dysfunction group. This~     treatment is standard care. Both groups will then undergo repeat objective vision testing by~     the developmental optometrist at 3 and 6 months to confirm that vision dysfunction has~     resolved. Resting state and task fMRI and DTI will be done at the same time to compare~     functional and structural connectivity changes between the 2 groups.~   "
60799|NCT02771054|"~     Many HIV-infected individuals on effective antiretroviral therapy with suppressed HIV RNA~     levels in blood as well as in cerebrospinal fluid have signs of low-level intrathecal~     inflammation. Our aim is to study if changing the nucleoside backbone in an antiretroviral~     regimen can decrease the residual intrathecal immune activation.~   "
60800|NCT02771041|"~     Arthroplastic hip surgery fast-track the subject of increasing interest and reduces the~     average length of stay and improve patient satisfaction. This fast circuit implemented in~     many schools uses dedicated inpatient units, preoperative patient education in~     multidisciplinary groups (including physiotherapists, nurses, rehabilitation doctors and~     surgeons), an analgesia protocol multimodal and a network dedicated to the outlet (1.2).~      The investigators working hypothesis is that the mere realization of a preoperative visit a~     week before the intervention would reduce the average length of stay for all patients with a~     target of two nights (instead of 7.5 days currently) (3) to reduce the use of SSR during~     hospitalization. This consultation would serve to explain to the patient the early course of~     care, give advice and help to anticipate acts for its release post-operative as, for~     example, contact a physical therapist and a nurse or check to their community pharmacy if~     their heparin stock is enough and to answer any questions (Appendix 2: early information~     given to the patient consultation J-8).~      The investigators protocol is inspired by the one already in place for outpatient PTH and PTH~     1 night but invariably apply to all patients for whom a home is considered output.~   "
60801|NCT02771028|"~     In this trial the investigators aim to establish whether Emotional Freedom Techniques (EFT)~     can reduce cognitive complaints in cancer survivors. All consenting patients aged 18 years or~     above, who have been diagnosed with a solid tumour of hematologic malignancy and who have~     completed or are in the late phase of a chemotherapy, radiotherapy, anti-hormonal or targeted~     therapy treatment, can participate in this trial. Patients should suffer from subjective~     cognitive complaints based on a score of 43 or more on the Cognitive Failure Questionnaire~     (CFQ). These patients will be randomly assigned to either the control or intervention group.~     Patients in the intervention group will be scheduled to receive an 8-week EFT intervention~     program. Other patients will be placed on an 8-week wait list after which patients will also~     start the EFT program.~   "
60802|NCT02771015|"~     Male or female subjects, 18 years and above, undergoing hip, knee or spinal surgery with an~     expected hospital stay for 4 days or more will be included in the trial. Individual trial~     duration will be for 7 days (follow-up). Two hundred subjects will be included in the trial,~     i.e. 100 subjects per arm. The treatment arm (either new or standard wound dressing) will be~     assigned by randomization stratified by type of surgery (i.e. hip, knee or spine).~   "
60803|NCT02771002|"~     The purpose of this study is to evaluate PPI as a surrogate for clinical signs of peripheral~     perfusion in patients in septic shock and after cardiac surgery.~   "
60804|NCT02770989|"~     This study is a prospective, non-randomized, single arm, multicenter, CE marking trial for~     patients with paroxysmal atrial fibrillation to undergo an ablation of the cardiac tissue~     near the PV.~   "
60805|NCT02770976|"~     This study is to investigate the effect of a wide range of assistance levels on respiratory~     pattern, breathing variability including tidal volume and peak inspiratory pressure during~     neurally adjusted ventilatory assist (NAVA) in preterm infants. The investigators also aim to~     explore whether the effects of NAVA on the electrical activity of diaphragm (Edi) signal~     amplitude, work of breathing and comfort of preterm infants.~   "
60806|NCT02770963|"~     This trial is designed to evaluate the efficacy of acupuncture on pain relief for patients~     with discogenic sciatica compared with sham acupuncture.~   "
60807|NCT02770950|"~     The purpose of this study is to further evaluate the clinical efficacy and safety of Zushima~     plaster for patients in knee osteoarthrosis post-marketing.~   "
60808|NCT02770937|"~     This is prospective randomized controlled study to compare the proficiency of novices in~     acquiring laparoscopic suturing skills following either training in a virtual reality~     simulator or box trainer.~   "
60809|NCT02770924|"~     The aim of this study is to evaluate the visual function of patients with bilateral~     implantation of the IOL trifocal ZEISS AT LISA TRI AND TRI TORIC by means of visual acuity~     tests with and without optical correction, sensitivity curve contrast, defocus curve and~     quality questionnaire visual function (VFQ-25).~   "
60810|NCT02770911|"~     The study evaluates the feasibility and advantage of modified laparoscopic double-staple~     anastomosis technique which to eliminate the 'dog ears' in laparoscopic rectal anterior~     resection.~   "
60811|NCT02770898|"~     Evaluating the impact of probation on probationers is necessary for both effective practice~     of probation officers and their assessment of the success of their work. At present, there~     are limited studies that have evaluated the impact of probation services on probationers and~     their family. There are even fewer studies that have examined interventions on probationers'~     well-being and family relations in a Chinese society. Compared with the general population,~     probationers are associated with poorer mental (e.g., depression, lower levels of~     self-esteem, high level of stress) and physical health, and often experience higher levels of~     family conflict, and poorer quality of family relationships. Given the vulnerabilities, there~     is a need to strengthen and promote healthy lifestyle and enhance individual and family~     well-being among probationers. As part of the FAMILY project, the current study focuses on~     FAMILY Holistic Health which emphasizes a comprehensive approach to improving physical,~     mental, and social health and well-being. This project will be conducted as a pilot project~     in the Social Welfare Department (SWD) in the Eastern District of Hong Kong. Interventions~     will be delivered to promote and enhance probationer's wellbeing, as well as enhancing FAMILY~     3Hs (Happiness, Health, and Harmony). Training programs will be provided to probation~     officers and/or workers of SWD in order to equip them with knowledge and skills in~     implementing health-related family intervention programs.~   "
60812|NCT02770885|"~     Glucagon like Peptide -1 (GLP-1) receptor agonists are well known to stimulate~     glucose-induced insulin secretion and to reduce energy intake. Recent findings from animal~     and human studies suggest a role of GLP-1 in regulating water and salt homeostasis. GLP-1 has~     been shown to reduce fluid intake after an oral salt load or during a meal - pointing to a~     hypodipsic effect. The aim of this study is to elucidate whether these putative hypodipsic~     properties of GLP-1 might be of advantage in persons with an exaggerated thirst perception as~     is the case in patients with primary polydipsia.~   "
60813|NCT02770872|"~     Cardiovascular disease (CVD) is the leading cause of death in developed nations and a major~     health issue in Veterans. Despite a number of different treatments, cardiovascular disease~     remains a major health burden, thus further treatments are needed. Individuals with obesity~     and/or diabetes are at particularly high risk for cardiovascular disease, and research~     suggests that elevated levels of serum amyloid A (SAA) may contribute to cardiovascular~     disease, particularly atherosclerosis. In preliminary studies in both mouse and human the~     investigators have identified that SAA appears to shift between lipid particles. SAA is~     mainly found on high density lipoprotein (HDL) particles; however, the investigators have~     found that in both mice and humans with obesity and/or diabetes SAA is found on low density~     lipoprotein (LDL) and very low density lipoprotein (VLDL) particles, and the investigators~     hypothesize that the presence of SAA on LDL or VLDL makes these particles more likely to~     cause cardiovascular disease. To determine what leads SAA to shift between lipid particles,~     SAA knockout mice will be injected with HDL containing SAA then blood collected at several~     time points over 24 hours, and the lipid particles will be isolated to measure SAA. In some~     experiments the investigators will compare different isoforms of SAA, different types of HDL~     particles, or induce expression of enzymes likely involved in shifting SAA between particles.~     To determine if the presence of SAA makes lipid particles bind vascular matrix more strongly,~     the investigators will collect carotid arteries and compare the extent of lipid particles~     bound to the vascular matrix in the vessel wall when the particles have or do not have SAA~     present. If this research confirms this hypothesis then the presence of SAA on LDL or VLDL~     may 1) be a new marker indicating humans at highest risk for cardiovascular disease and 2) be~     a new target of therapy to prevent cardiovascular disease.~   "
60814|NCT02770859|"~     POEM (Per-Oral endoscopic myotomy (creating a muscle [esophagus] opening), an incision-less~     (no cutting of the surface of the body) endoscopic procedure, is an effective non-surgical~     alternative to release the muscle & sphincter of the LES for the treatment of achalasia.~   "
60815|NCT02770846|"~     The purpose of this prospective randomized clinical study was to compare implant survival,~     patient satisfaction, and radiographic, clinical, and aesthetic outcomes following immediate~     loading (IL) and delayed loading (DL) of single dental implants after 1,3 and 5 years of~     follow-up.~   "
60816|NCT02770833|"~     The hypothesis is that seafood proteins given in combination with carbohydrates with low GI~     are superior to seafood proteins in combination with carbohydrates with high GI and meat in~     combination with both carbohydrates with low and high GI in promoting energy expenditure and~     satiety. The overall objective of this study is to investigate the acute effects of meals~     containing fish versus meat proteins on energy balance (thermogenesis, appetite regulating~     hormones and appetite sensations), markers of glucose allostatis and amino acid metabolism.~   "
60817|NCT02770820|"~     This phase I/II trial studies the side effects of laboratory-treated (central memory/naive)~     cluster of differentiation 8+ T cells (autologous Wilms tumor [WT]1-T cell receptor [TCRc]4~     gene-transduced CD8-positive central memory T-cells [TCM]/naive T cells [TN] lymphocytes) and~     how well it works in treating patients with acute myeloid leukemia that is newly diagnosed or~     has come back. Genetically modified therapies, such as autologous WT1-TCRc4 gene-transduced~     CD8-positive TCM/TN lymphocytes, are taken from a patient's blood, modified in the laboratory~     so they specifically may kill cancer cells with a protein called WT1, and safely given back~     to the patient. The genetically modified T-cells have genes added in the laboratory to~     allow them to recognize leukemia cells that express WT1 and kill them.~   "
60818|NCT02770807|"~     This is an international, multi-center, one-year, randomized, prospective, double-blind,~     placebo-controlled, phase III study, designed to assess the effect of two non-overlapping~     dose ranges of EDS EP, administered by IV infusion once per month, on neurological symptoms~     of patients with Ataxia Telangiectasia.~   "
60819|NCT02770794|"~     This multicenter prospective clinical trial investigates the accuracy of ultrasound to~     predict relapse after discontinuation of infliximab and the efficacy/safety of~     readministration of infliximab in patients with rheumatoid arthritis in a low disease~     activity state.~   "
60820|NCT02770781|"~     The purpose is to examine the feasibility and preliminary effectiveness of the role of a~     personal trainer for non-metastatic breast cancer survivors to improve physical activity and~     well-being (in terms of quality of life).~   "
60821|NCT02770768|"~     The purpose of the present study is to understand the neurobiological mechanisms of action~     underlying sexual desire building on prior work Dr. Stephanie Cacioppo has done in which~     desire was not manipulated. In the present project, Dr. Stephanie Cacioppo is manipulating~     desire through Flibanserin (Addyi) vs. placebo and she will be measuring subjective sexual~     desire as a manipulation check. The investigators will address this goal using a double-blind~     randomized outpatient design and determine the pre-post neurobehavioral change in the~     Flibanserin group and investigate the extent to which Flibanserin normalizes brain activity~     in premenopausal women with HSDD and the extent to which regional brain activation is~     associated with changes in symptoms and behavior (as measured with self-report measures of~     sexual desire and/or eye-tracking movements).~   "
60822|NCT02770755|"~     This registry study will compile information about patients who are scheduled to receive or~     have received Adipose Derived Regenerative cells (ADRCs) prepared by Celution device to treat~     muscle and ligament sports injuries.~   "
60823|NCT02770742|"~     This is a prospective, observational study to evaluate patient satisfaction with colonoscopy,~     depending on whether sedation is used during the procedure or not. Patients will receive~     questionnaires before the procedure to assess the potential influence of patient criteria and~     after the procedure to assess satisfaction-scores and pain-scores. A validated satisfaction~     score (Schoen et al.) will be used for the primary outcome. As secondary parameters, pain-~     and sedation-scores will be assessed by the validated NAPCOMS score, as well as procedural~     quality indicators. The study will assess, whether adequate selection in regards to risk~     factors for sedated or unsedated colonoscopy, leads to similar satisfaction-scores within~     both groups.~   "
60850|NCT02770391|"~     This is a research study to test an investigational drug (Not FDA approved), ARN-509 given in~     combination with Leuprolide acetate (FDA approved) in men diagnosed with high-risk prostate~     cancer who have already selected to have surgery to remove their prostate gland as part of~     their treatment plan. The main purpose of this study is to determine how tumors make~     androgens (male hormones), which makes these tumors more aggressive and resistant to hormonal~     therapy and how a short period of treatment with ARN-509 and leuprolide acetate prior to~     surgery can affect the production of these hormones in normal and malignant prostate tissue.~   "
60851|NCT02770378|"~     A proof-of-concept clinical trial assessing the safety of the coordinated undermining of~     survival paths by 9 repurposed drugs combined with metronomic temozolomide (CUSP9v3 treatment~     protocol) for recurrent glioblastoma~   "
60852|NCT02770365|"~     To compare safety and efficacy of Perrigo's drug product compared to an FDA approved drug~     product in the treatment of vulvar and vaginal atrophy.~   "
60824|NCT02770729|"~     There has thus far been only one randomized and masked clinical trial in the world to~     evaluate the efficacy of the intraoperative intracameral injection of antibiotics with the~     objective of preventing endophthalmitis following cataract surgery. The ESCRS study from 2007~     confirmed that the intracameral use of cefuroxime reduced the incidence of endophthalmitis~     approximately fivefold. Unlike in Europe, where this drug came to be widely used after the~     2007 results, cefuroxime is not commercially available in Brazil. Many studies around the~     world have substituted cefuroxime with moxifloxacin, which is a drug that is easily found~     around the world in eye drop form. It is widely used in postoperative regimens in cases of~     ophthalmologic surgeries, and it is free of preservatives that are toxic to intraocular~     structures (corneal endothelial cells). Three studies (all respective) found that the~     intracameral use of moxifloxacin is safe and effective for preventing endophthalmitis~     following cataract surgery; however, no controlled, randomized, and masked clinical trials~     have been performed with this objective. If this trial confirms its hypothesis (a reduction~     in the incidence of endophthalmitis following cataract surgery) and if minimal side effects~     are reported, moxifloxacin may be an option for routine intracameral use during cataract~     surgery, thus reducing cases of endophthalmitis and consequent cases of blindness.~   "
60825|NCT02770716|"~     This study is to confirm the efficacy and safety of intravenous terlipressin versus placebo~     in the treatment of adult subjects with hepatorenal syndrome (HRS) Type 1.~   "
60826|NCT02770703|"~     Inguinal hernia repair can be considered as one of the most frequent surgeries in general~     surgery worldwide. Surgical hernia repair procedures can generally be divided into minimally~     invasive (TEP, TAPP) and open techniques (e.g. Lichtenstein) and are equivalent with some~     advantages and disadvantages. The posterior wall of the inguinal channel is usually~     reinforced by a synthetic mesh, while non-mesh based surgeries have been steadily abandoned.~      Two of the most frequent complications following hernia surgery are hernia recurrence and~     chronic groin pain. Latter can occur in up to 10%. Both represent a considerable~     socio-economic impact. While different surgical hernia procedures and mesh fixation~     techniques have been evaluated as influential factors, the impact of mesh position and mesh~     deformation on hernia recurrence and chronic groin pain is unknown. This may be even more~     important, since endoscopic and laparoscopic hernia surgery procedures (TEP, TAPP) carry the~     risk of suboptimal mesh positioning, due to the final steps at the end of the surgery, where~     the mesh position is not under direct visual control.~      Until now direct mesh visualization was impossible. A recent development of MRI visible~     meshes (DynaMesh® visible) provides the opportunity to evaluate mesh position and deformation~     after hernia surgery. In case of suspicious clinical hernia recurrence or postoperative~     chronic groin pain the mesh position can now directly be identified with Magnetic Resonance~     (MR) imaging preventing unnecessary explorative surgery.~      In this study the investigators plan to perform MRI scans to assess mesh position and~     deformation 90 days postoperatively and correlate it with the clinical status and pain score~     (VAS) of the patient. In order to allow for an optimal comparison of the post-operative mesh~     position in relation to the operative technique, patients will be randomized to minimally~     invasive (TEP, TAPP) and open techniques (e.g. Lichtenstein). To the investigators knowledge~     this is the first study investigating the impact of the three most common surgical hernia~     procedures on postoperative mesh position and deformation and its correlation to the clinical~     findings focussing on hernia recurrence and chronic groin pain.~   "
60827|NCT02770690|"~     While propofol is widely used an anesthetic induction medication, it causes the mild to~     moderate pain. Investigators will investigate the effect of ethyl chloride spray on propofol~     injection pain.~   "
60828|NCT02770677|"~     COPD patients will be recruited and randomly assigned into one of each group: 1) Control~     group or 2) Yoga group. In Yoga groups, subjected will be asked to participate in Modified~     Dantien Yoga training for 12 weeks (3 times/week, 60 min/time). The subjects will be~     evaluated their pulmonary function, functional fitness performance, dyspnea score, and~     quality of life at baseline and after 12 wk training.~   "
60829|NCT02770664|"~     Evaluate the efficacy, Safety and Pharmacokinetics of Intravenous single injection LC28-0126~     immediately before Percutaneous Coronary Intervention (PCI) in Patients with ST-segment~     Elevation Myocardial Infarction (STEMI).~   "
60830|NCT02770651|"~     The purpose of this study is to evaluate the incidence of late incomplete stent apposition~     (ISA) and un-coverage by optical coherence tomography (OCT) following everolimus-eluting~     stent (EES) with bioabsorbable polymer (SYNERGY™, Boston Scientific,Nattick, MA, USA) versus~     zotarolimus-eluting stent (ZES) with permanent polymer(Resolute Onyx™, Medtronic, Santa Rosa,~     CA, USA) implantation in patients with AMI at 12 months.~   "
60831|NCT02770638|"~     This study aims to establish clinical evidence for the use of scoop stretchers in the sports~     setting for spinal immobilisation and transport compared to the traditionally used long back~     boards through measuring tissue interface pressures over forty five minutes. All participants~     will be placed on both the scoop stretcher and the long back board for forty five minutes~     each, with at least 45 minutes between the two tests. A special mat that measures the~     pressure of the body against the board will be used to determine the pressure forces at~     certain points of the body touching the board (in mmHg). The participants will also be asked~     every five minutes during the experiment to rate the comfort of the device. Pressure measures~     from each participant on each board will be collated and assessed along with each~     participant's reported pain scores and comfort rating. The measurements from the tissue~     pressures will be analysed in real-time from the software connected to the pressure-mat and~     therefore show if pressures increase over time. A comparison between boards will be made.~   "
60832|NCT02770625|"~     The purpose of this study is to evaluate the safety and efficacy of ISU302 in patients with~     Type 1 Gaucher disease.~   "
60833|NCT02770612|"~     The specific aim of this study is to use a shared decision making tool to allow women who~     have undergone cesarean delivery (CD) to choose the amount of oxycodone the participants will~     be prescribed at discharge, within a range from 0-40 tablets. The study investigators will~     document additional information from medical record abstraction (age, race/ethnicity, medical~     and obstetrical conditions, previous opioid use, date of CD, indication for CD, anesthetic~     management during CD, duration and complications of CD, length of stay, pain medication use~     and pain scores on each postoperative day between CD and discharge). The investigators will~     then follow up with the participants by telephone at two weeks after discharge to assess the~     amount of opioid used, frequency of prescription refill, disposition of unused medication,~     and participant satisfaction with their post-cesarean pain control. The investigators~     hypothesize that the use of a shared decision making tool will decrease the amount of opioid~     prescribed while still providing participants with satisfactory pain control.~   "
60915|NCT02769546|"~     The primary objective is to administer a cross-sectional survey to directly compare the~     differences patients and physicians hold regarding ovarian cancer prognosis and survival,~     complications arising from treatment, and counseling on advance directives, living wills,~     palliative care, and hospice services. Overall, the project will pinpoint opportunities for~     better patient physician communication regarding prognosis and end-of-life care and allow for~     more informed and tailored decision-making.~   "
60834|NCT02770599|"~     Inflammatory Bowel Disease (IBD) refers to two chronic diseases (Crohn`s disease and~     Ulcerative colitis) both complex disorders requiring a long-term management, with significant~     healthcare resource consumption. Traditionally IBD patients has been treated by a variety of~     health care professional including doctors with specialist qualifications, assistant doctors,~     general practitioner or scarcity of follow-up-service. Lately there has been a shift in the~     health care service from conventional follow - up (CF) to a rising numbers of health care~     models in term of Multidisciplinary team (MDT) also including care for IBD patients. MDT-~     models have been identified as important for continuity in patient centred care where nurses~     have a key role within the team by enhancing patient care. Patients have directly access to~     the IBD nurse who performing independently consultations at the IBD - Policlinic. This study~     will test the hypothesis that MDT including an IBD - nurse is preferable concerning; patient~     reported Health Related Quality of Life (HRQoL) Quality of Care (QoC), and clinical outcomes~     including adherence. This will be a retrospective clinical quality survey with a single time~     point measurement, with consecutive recruitments of patients in the course of a 12-month~     period. Data will be collected from medical records and patient questionnaires. Investigators~     plan involving 300 participants aged >18 and < 80 recruited from Medical departments in North~     Norway and from Diakonhjemmet in Oslo. Half will be from CF-models and half from the IBD -~     MDT. The study have approval from the local Ethics committee and application to the Data~     protection Officer has been submitted. All participants are asked for provide written~     consent. The results can potentially contribute; to a better utilization of health care~     resources, improve quality of health and quality of care. In a nurse-perspective, this~     organising model can be valuable in recruiting nurses by presenting a new challenging task~     concept, and identify the gaps in their own knowledge and skills. A well-established MDT can~     also be reasonable in a cost effective way by decreasing hospitalisation and fee up clinical~     spaces for the gastroenterologist.~   "
60835|NCT02770586|"~     The hypothesis of this study is that positron emission mammography will provide comparable~     sensitivity to contrast-enhanced breast MRI in women with a high suspicion of breast cancer.~      The aim of this study is to determine the sensitivity of Positron Emission Mammography (PEM)~     relative to that of Contrast-enhanced breast MRI (CE-MRI) in women with a high suspicion of~     breast cancer~   "
60836|NCT02770573|"~     Aim: to investigate the clinical effectiveness over 12 weeks of three different biomaterials,~     nano-hydroxyapatite based, in the therapy of the dental sensitivity.~      Methods: The study is designed as a randomized clinical trial comparing: 1) Cavex Bite&White~     ExSense, 2) Teethmate™ Desensitizer , 3) Ghimas Dentin Desensitizer. The pain experience was~     generated by a cold stimulus directly to a sensitive tooth surface and assessed using the~     Visual Analogue Scale (VAS). The response was recorded before the application of the~     materials (PRE-1), immediately after (POST-1), at 1-week (POST-2), 4-weeks (POST-3) and~     12-week controls (POST-4).~   "
60837|NCT02770560|"~     Thrombotic dysfunction is a common complication of tunneled cuffed catheters (TCC) leading to~     inadequate dialysis dose, need to catheter replacement with as consequence progressive~     exclusion of vascular sites. Thrombolytic agent can be used as therapeutic locking solution~     to dissolve the clotting formed in of around the catheter lumen. There are few studies on the~     optimal approach of TCC-related thrombosis with thrombolytic containing locking solution~     (dose, number of administrations, timing of administration - intra or interdialytic use). The~     primary objective of this retrospective study was to compare the efficacy of inter versus~     intradialytic Urokinase containing locking solution on restoration of the TCC blood flow. The~     investigators also assess the question of multiple administrations of Urokinase are more~     efficient than one single administration~   "
60838|NCT02770547|"~     This study proposes to evaluate the potential of leg thermotherapy as a non-pharmacological~     intervention that could improve the mobility and exercise tolerance of patients with~     intermittent claudication. Thermotherapy is a simple, easily applicable therapy that enhances~     exercise tolerance in patients with chronic heart failure by improving peripheral vascular~     endothelial function.~   "
60839|NCT02770534|"~     The primary aim of this study is to investigate the reported enhanced coagulation status~     (prothrombotic status) in patients with sickle cell disease using 2 laboratory tests;~     thromboelastography (TEG) and Endogenous Thrombin Potential (ETP), and comparing the results~     to healthy race matched controls to ascertain if there is a significant difference. Race~     matching of the control participants is being carried out due to the well reported racial~     differences in coagulation parameters that exist in healthy individuals. The investigators~     are aiming to study the clotting state in sickle patients on regular transfusion therapy and~     those on hydroxycarbamide, both treatments offered to sickle patients to ameliorate the~     condition. The study will assess the reported prothrombotic state using TEG and ETP.~   "
60840|NCT02770521|"~     The aims of this study are to evaluate:~        -  The safety and tolerability of a single dose of treprostinil given subcutaneously (as an~          injection just under the skin)~        -  The pharmacokinetic profile (how the body absorbs, breaks down, and gets rid of) of a~          single subcutaneous dose of a new LY900014 formulation in healthy Japanese participants.~      The study has two parts. Participants may only enroll in one part.~   "
60841|NCT02770508|"~     The purpose of this study is to compare the safety and efficacy of a combination of a QD~     regimen consisting on ritonavir boosted darunavir (FDC) and lamivudine versus ritonavir~     boosted darunavir (FDC) plus co-formulated tenofovir and emtricitabine or co-formulated~     tenofovir/lamivudine in naïve HIV-1 infected patients. Subjects will be ARV-naïve~     HIV-1-infected patients eligible to start ARV therapy according to current~     guidelines.Subjects will be adults ≥ 18 years of age who meet all of the inclusion criteria~     and none of the exclusion criteria.~   "
60853|NCT02770352|"~     The objective of this proposal is to create a database for obstetric fistula patients at~     Bwaila Hospital containing their demographics, obstetric history, fistula history, physical~     exam findings, intraoperative and postoperative results. Data collection will be prospective~     starting in 2011 upon institutional review board (IRB) approval to last a minimum of five~     years and will have a retrospective component tracing back to January 2010. Primary goals of~     data analysis will be to determine the risk factors for fistula formation, risk factors for~     poor surgical outcomes and long-term incontinence, social and economic impact of fistula~     repair, and the ability of various physical exam findings to predict likelihood of successful~     repair. It is expected that findings will lead to improved surgical management of obstetric~     fistulas both locally and internationally.~   "
60916|NCT02769533|"~     This study is focusing on patients presenting with suspected malignancies of the pituitary~     gland who are considered to be good surgical candidates.The primary end-point of the study is~     to determine the sensitivity of OTL38 uptake and expression in identifying those nodules when~     excited by an imaging probe.There will be a single dose of 0.025 mg/kg for intravenous~     injection over approximately 60 minutes, two to three hours, prior to surgery.~   "
60842|NCT02770495|"~     It is assumed that gut inflammation and lesions characterizing flares of Crohn's disease (CD)~     result from an aberrant T-cell mediated immune responses characterized by a complex balance~     between peripheral and lamina propria regulatory and effector T cell subsets. Because most of~     CD patients who undergo a surgery experienced a postoperative endoscopic recurrence of the~     disease (70 % at one year) leading to a clinical recurrence (10 % per year), the model of~     postoperative recurrence in CD represents a privileged situation that mimicks what happens in~     the gut of CD patients in clinical remission before the occurrence of further flares. It is~     likely that the same factors which underlie the immunopathogenesis of CD at its early stages~     also contribute to disease recurrence in the postoperative setting. Indeed, the postoperative~     state is performed for intent of disease remission and this situation represents probably an~     ideal setting to investigate the dynamics of most of T cell subsets in the peripheral and~     mucosal compartments because one may argue that removal of the diseased segment of bowel~     resets the disease to its earliest phases, providing an interesting window to better~     understand which T cell subsets predispose to disease recurrence.~      That is the reason why this model will be used in the present project i) to understand better~     the immunopathogenesis of CD relapse; ii) to identify novel and promising immune~     cell-associated biomarkers capable to predict relapse of the disease and finally iii) to~     identify potential specific therapeutic target associated with T cell subsets involved in the~     initiation of disease.~   "
60843|NCT02770482|"~     The combined measurement of Ab42 and tau protein (total and phosphorylated) in the spinal~     fluid has been shown to be promising in the diagnosis of Alzheimer's disease (AD), and has~     justified its inclusion new diagnostic criteria. However, it can sometimes yield discordant~     results that are not discriminant (isolated variation in Ab42 or P-181 Tau). To answer this~     challenge, a new marker has been developed in recent years, namely amyloid beta-peptide 1-40~     (Aβ40). This marker reflects the patient's total amyloid deposits and is used to calculate~     the Aβ42/Aβ40 ratio. This ratio measures the relative variation of Aβ42 as compared to the~     total amyloid burden. Literature data on this topic are sparse and to date, no report has~     been published evaluating the utility of this marker in the diagnostic strategy for AD.~   "
60844|NCT02770469|"~     The objective of the TOGETHER (Together Overcome and Get Empowered Through Health Education~     and Relationships) program was to examine the effectiveness of one of the first~     linguistically and culturally tailored intervention programs to increase quality of life~     among Korean American breast cancer survivors.~   "
60845|NCT02770456|"~     This randomized controlled trial with fish oil supplementation to pregnant women conducted in~     areas of China, which are generally low in fish intake and low income, aims at answering the~     following primary questions:~        -  Is a dose of 2.0 g/d long chain n-3 fatty acids efficient in preventing preterm birth~        -  Is a dose of 0.5 g/d long chain n-3 fatty acids efficient in preventing preterm birth~        -  Is a dose of 0.5 g/d as efficient as a dose of 2.0 g/d in affecting timing of~          spontaneous delivery in the preterm period~   "
60846|NCT02770443|"~     Randomized study of medication withdrawal in patients who have recovered LV function in~     Dilated Cardiomyopathy.~   "
60847|NCT02770430|"~     Steroids are still the first line treatment for established severe~     acute-graft-versus-host-disease (aGVHD), with a response rate of 30-50%, and there is no~     established and effective therapy for severe steroid-refractory (aGVHD). The outcome for~     patients is poor and overall survival low, with few patients alive at 2 years.~      In the case of failure after corticosteroid treatment, different therapeutic options have~     been introduced as second or third-line strategies. In this scenario, infusion of ex vivo~     expanded mesenchymal stromal cells (MSCs) has emerged as an additional tool for treatment of~     GVHD.~      The purpose of this work is conduct a study in patients with refractory and/or resistant GVHD~     corticosteroids treatment. It will be randomized into two groups: one group that will receive~     the MSCs and the other group will follow the acute GVHD steroid-resistant and/or refractory~     treatment according to the routines of the Bone Marrow Transplantation (BMT) service of~     Hospital de Clinicas de Porto Alegre. It will be evaluated aspects of immune recovery early~     after MSCs infusion.~   "
60848|NCT02770417|"~     Preliminary evidence suggest that patients with chronic obstructive pulmonary disease (COPD)~     suffer from lower-limb muscle dysfunction. This may, at least in part, be due to a~     combination of physical inactivity and muscle oxidative stress. Pilot data (not published)~     clearly show that patients with COPD have significantly lower carnosine, which is a pH~     (acidity-basicity level) buffer and antioxidant, levels in the m. vastus lateralis compared~     to healthy subjects. Beta-alanine supplementation has shown to increase muscle carnosine in~     trained and untrained healthy subjects. This study will assess if muscle carnosine can be~     augmented by beta-alanine supplementation in 40 COPD patients (20 patients receive~     beta-alanine, 20 patients receive placebo). 10 healthy elderly controls will also be assessed~     to compare baseline muscle carnosine levels.~      The aims of this study are to:~        1. Investigate baseline muscle carnosine levels to confirm the pilot data in a larger~          sample of patients with COPD compared with healthy elderly subjects~        2. Investigate if beta-alanine supplementation augments muscle carnosine in COPD patients~          and whether it has an influence on exercise capacity, lower-limb muscle function and~          quality of life~        3. To investigate baseline and post supplementation structural and metabolic muscle~          characteristics and markers of oxidative stress and inflammation in COPD patients and~          it's association with muscle carnosine levels~   "
60849|NCT02770404|"~     This is a Phase 1, randomized, double-blind, single-center, placebo-controlled,~     sequential-cohort study in at least 60 healthy adult male and female subjects. Subjects in~     Cohorts 1 through 5 will be randomly assigned in an 8:2 allocation to receive active or~     placebo treatments. Subjects in Cohort 6 will be randomly assigned in a 1:1 allocation to~     receive an IV dose of nafithromycin and a single oral dose of nafithromycin in each crossover~     period. Subjects in each of Cohorts 1, 2, and 3 will receive a single dose of 100, 200, or~     400 mg, respectively, of nafithromycin or matching placebo on Day 1.~   "
60868|NCT02770157|"~     A study demonstrates the non-inferiority of DA-3002 when compared with Genotropin® in short~     children born small for gestational age.~   "
60869|NCT02770144|"~     The investigators have partnered with financial coaching organizations to establish what the~     investigators have termed a Medical-Financial Partnership (MFP) that offers financial~     coaching to improve financial and mental health.The investigators will evaluate the MFP's~     impact on child overall health rating.~   "
60854|NCT02770339|"~     The purpose of this study is to determine the proportion of children presenting to a~     pediatric emergency department with an acute mental health/behavioral crisis or clinical drug~     toxicity who have a match or mismatch between the genes for drug metabolizing enzymes and~     their current or recent drug therapy. The investigators will utilize a readily available and~     FDA-approved cheek swab DNA test --GeneSight®--in these children that categorizes patients~     into 3 different type of groups - RED, YELLOW, and GREEN based on individuals' abilities to~     metabolize psychotropic drugs . Specific objectives include:~        -  The relationship of genomic mismatch to serum drug concentrations, either low or high~        -  The proportion of children with a genomic mismatch who present to PED with intentional~          self-injury.~        -  The relationship between match versus mismatch and self- and caregiver-reported outcomes~          of functioning, drug efficacy, and drug tolerability.~        -  Examine the proportion of children/adolescents who present to PED with an adverse drug~          reaction to one or more psychotropic with a genomic mismatch.~        -  Quantify the specific adverse reactions related to a mismatch of genotypes.~   "
60855|NCT02770326|"~     The purpose of this study is to test the safety of FMT in patients with C. difficile and~     cancer. In previous other studies, FMT has been shown to cure C. difficile when antibiotics~     have failed, but most of these studies have not included patients with cancer. The~     investigators want to prove that FMT is safe in this group of people so that doctors will~     feel more comfortable prescribing it for their patients with cancer.~   "
60856|NCT02770313|"~     The goal of this study is to determine how effective repeated fasting over 26 weeks (6~     months) is at improving risk parameters that are surrogate endpoints for cardiovascular~     diseases, metabolic dysregulation and cognitive impairments.~      Subjects will be randomized 1:1 to water-only fasting or to their ad libitum usual diet, with~     randomization performed within strata based on fasting history (≤180 hours or 181-720 hours~     of total fasting for >12 consecutive hours per episode in the previous two years). Subjects~     will be assessed at 4, 13 and 26 weeks following randomization.~   "
60857|NCT02770300|"~     The primary goal of this project is to test the safeness and clinical effectiveness of a~     novel exoskeleton for the upper limb (Arm Light Exoskeleton Rehab Station, ALEx RS) developed~     at Wearable Robotics srl, for the force assistance of stroke patients during~     robotic-rehabilitation.~      The secondary study aim is to design and test an automatic personalized robot-based upper~     limb motor rehabilitation protocol targeting the specific kinematic performance of each~     patient.~      Finally, the study also aims to define the neuro-biomechanical state of the patient and its~     evolution during the therapy by studying cortical signals and muscular synergies. This~     information will be used to improve the personalization of the robotic treatment by targeting~     not only the motor performance but also the cerebral and muscular activity of the patient.~      The study is longitudinally designed in order to test the safeness and clinical effectiveness~     of ALEx RS over time, and to monitor the clinical effectiveness of the automatic personalized~     robotic therapy from the beginning until the end of the treatment. Moreover, in order to~     estimate the long-term clinical effectiveness of the treatment, the assessment methods~     proposed in the clinical trial will be repeated one month after the end of the treatment.~   "
60858|NCT02770287|"~     The study will confirm that the Freeze Diamond polar applicator is safe for treating the Mons~     pubis and Labia, and will result in improvement in general skin appearance including an~     improvement in skin irregularities and skin laxity.~   "
60859|NCT02770274|"~     To compare the safety and effectiveness of dual anti-platelet therapy with cilostazol 100 mg~     twice daily and aspirin 100 mg daily versus monotherapy with aspirin 100 mg daily in patients~     undergoing peripheral angioplasty or stenting or both for the management of peripheral~     arterial disease.~   "
60860|NCT02770261|"~     The purpose of this study is to determine superiority of DP-R208 compare to each monotherapy~     in patient with hypertension and primary hypercholesterolemia.~   "
60861|NCT02770248|"~     The purpose of this study is to evaluate differences between treatments in mean change from~     baseline in 24-hr intraocular pressure (IOP) at Week 4.~   "
60862|NCT02770235|"~     In diabetics there is an abnormally increased production of AGEs due to hyperglycemia. An~     association was shown between AGE measured by biopsy (invasive) and DE patients with diabetes~     (increase of AGE level in the corpora cavernosa). To date no studies have explored the link~     between DE and the measure of AGE by a non-invasive method of Auto-fluorescence (AF) Skin~     (AGEReaderTM).~      If the hypothesis of an association between DE and AGE measured by AF was checked, screening~     for erectile dysfunction and measurement of AGEs could help to improve the overall management~     of diabetic patient (including cardiovascular) and their quality of life.~   "
60863|NCT02770222|"~     The primary objectives of this 2-part drug interaction study are as follows:~        -  To evaluate the effect of gemfibrozil on the pharmacokinetics (i.e., amount in the~          blood) of selexipag and its metabolite ACT-333679 (Part I).~        -  To evaluate the effect of rifampicin on the pharmacokinetics of selexipag and its~          metabolite ACT-333679 (Part II).~   "
60864|NCT02770209|"~     This study is aimed at evaluating the feasibility and effectiveness of a completely natural~     tissue engineered cartilage, composed of a self-made tissue engineered oriented scaffold and~     autologous chondrocytes, for repairing articular cartilage damage following injury. And it is~     also aimed at investigating the safety of tissue engineered cartilage transplantation.~   "
60865|NCT02770196|"~     The purpose of this study is to better understand how participation in cost-subsidized~     community supported agriculture programs paired with tailored education can affect diet~     quality and energy balance among children in low-income households.~   "
60866|NCT02770183|"~     The rational of the study is the description of the evolution of systolic cardiac function~     post-stunning, evaluated by transesophageal minimally invasive echocardiography (hTEE). The~     uses of these non-invasive methods have proved to be accurate for the qualitative and~     semi-quantitative determination of the contractile function of the left ventricle and the~     volume status of the patient. Furthermore the use of this technique has been demonstrated to~     be a reliable method to analyze the stunning recovery infarction after controlled cardiac~     arrest during the extra-corporeal circulation.~   "
60867|NCT02770170|"~     The overall purpose of the study is to assess the efficacy of three different doses of BI~     655064 against placebo as add-on therapy to standard of care (SOC) treatment for active lupus~     nephritis in order to characterize the dose-response relationship within the therapeutic~     range, and select the target dose for phase III development.~   "
60871|NCT02770118|"~     The goal of this proposed research is to test the hypothesis that long-term mild sleep~     restriction (SR), as occurs frequently in adults and adolescents, leads to a positive energy~     balance and weight gain.~      Aim 1. To determine the effects of SR, relative to habitual sleep (HS), on food choice and~     energy intake (EI) in adults at risk of obesity.~        -  Hypothesis 1a. EI, assessed by multiple weekly 24-hour recalls, will be greater during a~          period of SR relative to HS. This will be mostly due to increased fat and carbohydrate~          intakes.~        -  Hypothesis 1b. Neuronal responses to food stimuli, assessed by functional MRI (fMRI)~          after 6 weeks of SR or HS, will indicate increased activity in networks associated with~          reward and food valuation (insula, orbitofrontal cortex) during a period of SR relative~          to HS. These responses will be correlated with intakes of high carbohydrate and high fat~          foods (hypothesis 1a) and neuropeptide Y (NPY). Moreover, activation of the default mode~          network (DMN) will be suppressed to a lesser extent after SR compared to HS.~      Aim 2. To determine the effects of SR, relative to HS, on energy expenditure (EE) via~     independent and complementary approaches.~        -  Hypothesis 2a. EE, assessed by doubly-labeled water (DLW), and physical activity level,~          monitored daily by actigraphy, will be lower during SR relative to HS.~        -  Hypothesis 2b. Brown adipose tissue (BAT), assessed by positron emission tomography and~          magnetic resonance combined scanner (PET/MR) using 18F-fluorodeoxyglucose (18FDG-PET)~          and fat fraction (FF) measurement under cold stimulation, will be greater after SR~          relative to HS. This would suggest higher adaptive thermogenesis after SR compared to~          HS. BAT activation will also be correlated with NPY.~      Aim 3. To determine whether SR alters body weight and adiposity relative to HS.~        -  Hypothesis 3a. SR will lead to weight gain and increased total adiposity, as assessed~          using magnetic resonance imaging (MRI), relative to HS.~        -  Hypothesis 3b. Increased adiposity after SR will be correlated to an adverse~          cardio-metabolic risk profile (increased glucose, insulin, triglycerides, leptin,~          reduced high-density lipoprotein cholesterol and adiponectin) and neuronal responses to~          food stimuli (Hypothesis 1b), and EE (Hypothesis 2a & 2b). Failure to stimulate BAT with~          SR will be associated with greater gain in adiposity.~   "
60872|NCT02770105|"~     L-theanine and caffeine are nutritional compounds that are naturally found in tea. Our recent~     findings using an EEG paradigm are consistent with the findings of others, indicating that~     intake of L-theanine and caffeine reduce the time needed for a person to differentiate~     between two visual stimuli and react to only one stimulus. In order to understand how these~     compounds give rise to these improvements, the investigators need to study how these~     compounds are related to various areas of the brain. To achieve this, the investigators plan~     to scan the brains of nine participants after they take either 1) L-theanine alone, 2)~     caffeine alone 3) the combination of both L-theanine and caffeine as compared with a placebo~     (distilled water), to see which has the greatest impact on attention and on regions in the~     brain that bring about attention.~   "
60873|NCT02770092|"~     Weight loss commonly occurs in patients with chronic heart failure (CHF) and chronic~     obstructive pulmonary disorder (COPD), negatively influencing their quality of life,~     treatment response and survival. Loss of muscle protein is generally a central component of~     weight loss in CHF and COPD patients, but patients also have reductions in fat mass and bone~     density, independent of the severity of the disease state. The purpose of this study is to~     provide detailed insight in disease related gut function by obtaining information on gut~     permeability, digestion and absorption of glucose, fat and protein in CHF and COPD patients~     compared to matched healthy controls. This will provide required information that is~     necessary to implement new strategies to develop optimal nutritional regimen in CHF and COPD.~   "
60874|NCT02770079|"~     Aim of the study:~      To define insulin requirement during pregnancy and to identify the rapid changes in insulin~     sensitivity around parturition and the first 6 months post partum. Such knowledge would be~     clinically useful and markedly improve insulin treatment before and after parturition for~     women with type 1 diabetes and serve to identify the best possible timing of testing women~     with gestational diabetes mellitus (GDM) for the development of type 2 diabetes post partum.~      Method:~      Botnia clamp in women before, immediately after delivery and 6 months post partum. The~     investigators will compare 20 women with GDM in late pregnancy, day 15 post partum and 6~     months post partum with 20 normal women investigated at the same time points. In addition the~     investigators will collect feces samples from the mother and baby in order to determine~     microbiota.~      Perspectives:~      Diabetes is a common condition with important implications for pregnancy outcome and~     long-term morbidity for mother and offspring. Accordingly, tailoring the best treatment is~     expected to have beneficial consequences both for the pregnant women and the future~     generation.~   "
60875|NCT02770066|"~     A prospective Danish national registry of percutaneous transluminal renal angioplasty (PTRA)~     in high-risk patients with renal artery stenosis selected on the basis of common national~     criteria, and with a common follow-up protocol for all three Danish centres offering PTRA~   "
60876|NCT02770053|"~     The purpose of this study is to determine whether enlarging the apical foramen causes~     postoperative pain in teeth with necrotic pulp and apical periodontitis.~   "
60877|NCT02770040|"~     The purpose of this study is to identify whether an Accelerated or Intensified Infliximab~     induction regimen is superior to Standard induction in Acute Severe Ulcerative Colitis in an~     open label multi-centre randomised controlled trial.~   "
60878|NCT02770027|"~     After obtaining approval from the Institutional Review Board of our institution, written~     informed consent is obtained from patients undergoing colon surgery are enrolled in this~     prospective study and randomly allocated into one of two groups: Group-C (n=15) and Group-HES~     (n=15).~      All recruited patients will be given patient identification number (PIN) for the present~     study of 01-30 according to their order of interview and recruitment. Investigators will~     prepare 15 yellow and 15 green cards, which will be inserted in 30 thick-paper envelopes.~     Then, all envelopes will be sealed, mixed and randomly allocated to get numbers of 01 to 30~     (Envelop number).~      According to the color of the card, attending anesthesiologists will give crystalloid for~     yellow card or HES for green cards, respectively, to maintain stroke volume variation < 15~     during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture.~      Patient data and statistical analyses:~      Patient's data whole blood viscosity, PaO2, FiO2, Hemoglobin, urine amount, s-glucose will be~     determined from the patients' medical record after patient's discharge.~      All statistical analyses will be performed after the 30th patient's discharge and data~     acquisition~   "
60879|NCT02770014|"~     Patient with Non-Small Cell Lung Cancer (NSCLC) that might have a genetic change (mutation)~     in the Epidermal Growth Factor Receptor (EGFR) are invited to take part in this study.~      This research study is evaluating a new blood test that is capable of detecting an EGFR~     mutation in cancer without a biopsy.~   "
60917|NCT02769520|"~     The purpose of this study is to determine whether pembrolizumab, when given after salvage~     surgery, is effective in increasing the time a person with squamous cell cancer of the head~     and neck remains disease-free following locoregional disease recurrence.~   "
60918|NCT02769507|"~     The present study aims to investigate whether transcranial direct current stimulation (tDCS)~     reduces auditory hallucinations in patients with psychosis. In addition, the neuronal changes~     of tDCS will be examined.~   "
60880|NCT02770001|"~     Background: In genetic studies, the quality of DNA samples is tested first. Samples that are~     low-quality are not used. Some studies involve minority ethnic groups. And example is admixed~     African American. These studies often have small sample sizes. It is important to make sure~     samples are not discarded unnecessarily. This may happen by using quality control (QC)~     thresholds for homogenous groups. These may not be appropriate for an admixed group.~     Researchers want to study samples that failed certain QC tests. They want to see if this has~     to do with the ancestry of the outliers or the quality of the samples.~      Objectives:~      To study samples that fail heterozygosity and sample genotype call rate QC. To see if the~     failing rates have to do with the ancestry composition of the outliers or the quality of the~     samples.~      Eligibility:~      No new participants. Researchers will review data that has already been collected.~      Design:~      Researchers will study DNA samples in a lab.~      The samples will not include data that can identify the person the sample came from.~   "
60881|NCT02769988|"~     Background:~      The Teen Health Information Literacy Project is an after-school program for high school~     students. It gives them skills to access valid and reliable health data. It also aims to grow~     young health advocates. Researchers want to find out more about the impact the program has~     had on students. They want to use this feedback to improve the program.~      Objective:~      To gain feedback about the Teen Health Information Literacy Project.~      Eligibility:~      Young people who participated in the Teen Health Information Literacy Project. The project~     was run by Area Health Education Centers (AHECs) and sponsored by the National Library of~     Medicine (NLM).~      Design:~      The study will be explained to students during a program session. They will take consent~     forms home to their parents.~      Participants will split into 6 focus groups. Each one will be conducted at an AHEC project~     site.~      The focus group will be a 90-minute discussion between participants and an evaluator from the~     NLM. The evaluator will be present either in person or by video conference.~      The evaluator will ask participants questions, which may include the following. What did they~     like and dislike about the program? Why did they decide to participate? What have they~     learned? Would they recommend this program to another student? How has the program affected~     their interest in health-related careers?~      The discussion will be audio-recorded. The evaluator will use an automated tool to convert~     recordings into text. After that, she will destroy the audio.~   "
60882|NCT02769975|"~     Background:~      Endocrine glands give off hormones. Researchers want to learn more about the disorders that~     affect these glands in children. These disorders might be caused by changes in genes. Genes~     contain DNA, which is the blueprint of how a cell works. Researchers want to identify the~     genes involved in endocrine and metabolic disorders. This might help develop new ways to~     diagnose and treat the disorders.~      Objective:~      To study the inheritance of endocrine or metabolism disorders.~      Eligibility:~      Children ages 0 18 with known or suspected endocrine or metabolism disorders.~      Family members ages 0 100. They may participate in the DNA part of the study.~      Design:~      Participants will be screened with a review of their medical records. Their parents or~     guardians will allow the records to be released.~      Participants will have a clinic visit. This may include a physical exam and medical history.~      Parents or guardians will give their consent for the study. Participants may have tests,~     surgery, or other procedures to help diagnose or treat their condition. These could include:~      Blood, urine, and saliva tests~      Growth hormone test~      Pituitary and adrenal function tests~      Picture of chromosomes~      Imaging tests. These may include X-ray, ultrasound, scans, or a skeletal survey.~      Genetic tests~      Sleep study~      Medical photographs~      If surgery is done, a tissue sample will be taken.~      Participants may have follow-up visits for diagnosis and treatment.~      Participating relatives will have one visit. This will include medical history and blood and~     saliva tests. The blood and saliva will be used for DNA testing.~   "
60883|NCT02769962|"~     Background: CRLX101 consists of a sugar molecule cyclodextrin linked to a chemotherapy drug~     called camptothecin. The combined molecule or nanoparticle drug conjugate travels through the~     blood. Once inside cancer cells, the chemotherapy drug is released from the molecule.~     Olaparib is a drug that may stop cancer cells from repairing the DNA damage caused by~     chemotherapy. Researchers want to see how safe it is to give CRLX101 and olaparib together~     and to see how well the combination treats a specific type of lung cancer called small cell~     lung cancer (SCLC).~      Objectives:~      To test the safety and maximum dose of CLRX101 and olaparib together. To test how well they~     treat small cell lung cancer.~      Eligibility:~      Adults 18 and older with small cell lung cancer.~      Design:~      Participants will be screened with standard cancer care tests.~      Participants will get the 2 study drugs in 28-day cycles. CRLX101 will be given every 2~     weeks, through a small plastic tube in an arm vein. Olaparib will be taken by mouth twice a~     day most days. Participants will keep a pill diary.~      For Cycle 1, participants will have 3 visits. All other cycles will have 2 visits.~      At study visits, participants may have:~      Blood and hair samples taken~      History and Physical exam~      Questions about health and side effects~      Pregnancy test~      Optional tumor biopsy where a piece of tumor is removed by needle after numbing the skin. .~      CT scan~      Injection of CRLX101 (twice per cycle)~      <TAB>Olaparib prescription <TAB>~      Participants will have a follow-up visit 4 weeks after finish taking the drugs. They will~     have a physical exam and blood tests. They may have a tumor biopsy. The study team will call~     the patient every 3 months for follow up after completing the study treatment.~   "
60884|NCT02769949|"~     Background: Some patients with unusual genetic conditions are referred to the National~     Institutes of Health (NIH). They may not be eligible to join current research studies.~     Testing such patients is a good way to improve the skills of research staff. The findings~     could lead to new processes and research.~      Objectives:~      To recruit a diverse group of pediatric subjects with genetic disorders. To give clinic staff~     hands-on experience working with these patients.~      Eligibility:~      Children any age with a known or suspected genetic disorder.~      Design:~      Participants will be screened with medical history and physical exam. They may have lab and~     other tests.~      Family members may give DNA samples.~      Participants will have:~      Medical history~      Physical exam~      Height, weight, and other measurements taken.~      A clinical evaluation of their disorder.~      They may have:~      Blood, urine, and saliva samples taken~      Imaging tests. These may include x-rays, scans, ultrasound, or skeletal survey.~      A sleep study~      A visit with other specialists at NIH~      A genetic test from a commercial lab~      Medical photographs taken~      Other tests~      Participants may have follow-up visits. They may get medical or surgical treatment.~   "
60885|NCT02769936|"~     Impairments in plasticity and working memory in schizophrenia have been hypothesized to~     reflect dysfunction at the N-methyl-D-aspartate glutamate receptor (NMDAR). However, the~     specific mechanisms through which the NMDAR is involved in working memory versus plasticity~     differ. Towards gaining a deeper understanding of how NMDAR signaling relates to individual~     cognitive functions in healthy adults and patients with schizophrenia, the investigators used~     a single dose of d-cycloserine (DCS) as an experimental probe to examine the effects of~     enhancing NMDAR signaling on plasticity versus working memory in healthy adults and~     individuals with schizophrenia.~   "
60886|NCT02769923|"~     The investigators will assess the usability and immune response following fractional dose~     inactivated polio virus vaccine (fIPV) administration with two novel intradermal adapters (ID~     adapter by West Pharmaceutical services Inc. and Star Intradermal syringe by Star Syringe~     Ltd.) and compare the response with the one achieved with fIPV administered with traditional~     BCG needle syringe.~   "
60887|NCT02769910|"~     The purpose of this project is to investigate the effect of capsaicin-induced neurogenic~     inflammation with three different intensities on itch subsequently induced by histamine and~     cowhage. The hypothesis is that capsaicin-induced pre-established neurogenic inflammation~     significantly increases susceptibility to itch provocations with cowhage and histamine.~   "
60888|NCT02769897|"~     The study aims to evaluate the possible effects of an exercise program, nutritional and~     psychological, postural orientation and guidance of oral health on body composition, physical~     activity levels and lifestyle, physical fitness and health and motor performance, the factors~     risk of cardiovascular disease, eating habits, the cognition levels, the psychological~     profile, the body posture of children and adolescents with overweight and obesity,~     considering the presence of risk genotype associated with the development of obesity. In~     addition, identify the effects of orientation for oral health on the quality of life and~     healthy oral habits.~   "
60889|NCT02769884|"~     This study trials a prototype artificial pancreas system that consists of a Roche insulin~     pump, a Dexcom continuous glucose monitor (CGM), and an experiential MMPPC (multiple model~     probabilistic predictive control) algorithm housed on an android cell phone. The system doses~     insulin based on CGM sensor glucose levels and the experimental algorithm.~      The aim of this clinical study is to determine the efficacy of the MMPPC controller in~     adolescents and adults with type 1 diabetes in a hotel setting.~   "
60890|NCT02769871|"~     The investigators aim to examine the effect on smoking cessation rate by showing stroke~     patients who are active smokers images of their strokes.~   "
60891|NCT02769858|"~     The proposed study aims to establish the feasibility of light therapy for postpartum~     depression delivered via Re-Timer, demonstrate its preliminary efficacy, and illuminate~     relationships between circadian shifts and mood changes using a novel, home-based circadian~     biomarker assessment paradigm (salivary dim light melatonin onset; DLMO).~   "
60892|NCT02769845|"~     Prospective screening and treatment study for children with Sickle Cell Anemia and increased~     stroke risk living in the Dominican Republic.~   "
60893|NCT02769832|"~     The purpose of this research study is to see if Abraxane and Gemcitabine given together will~     be effective in treating small cell lung cancer that has progressed after one line of~     treatment.~   "
60894|NCT02769819|"~     This study is designed to identify patients' features predictive of difficult endotracheal~     intubation using a flexible fiberscope.~   "
60895|NCT02769806|"~     The primary aim of this project is to Compare new msCS and standard DSC-PWI methods in GBM~     patients undergoing post-operative MRI for monitoring of tumor progression.~   "
60896|NCT02769793|"~     The purpose of this study is to determine whether levodopa/benserazide dispersible is~     effective in the adjunctive treatment of Parkinson's disease (PD) patients with delayed ON.~   "
60897|NCT02769780|"~     Nexus is a collaboration between academic institutions, advocacy and industry to answer~     important questions about narcolepsy. It is a web-based observational study of~     patient-reported outcomes in adult patients with narcolepsy, with follow-up every six months.~      Nexus website: www.narcolepsyregistry.com~   "
60898|NCT02769767|"~     HLA-DRB1 * Gene and some genes involved in inflammation and immunity (IL-7R, GPC5, CTSS) have~     been linked to risk of MS and the response to treatment with immunomodulators. This research~     aims to estimate the risk that confers some variations in the sequence of these genes.~   "
60899|NCT02769754|"~     This prospective randomized study aims to determine the influence of the use of local~     hemostatic on the incidence of local complications derived from the edge of transection:~     biliary fistula or bleeding, after scheduled hepatic resection.~   "
60900|NCT02769741|"~     This study will assess the nutritional effect of cashews on LDL-C concentrations and~     secondarily on other aspects of the fasting lipoprotein lipid profile in healthy men and~     women with moderately elevated cholesterol.~   "
60901|NCT02769728|"~     The aim of the study is to explore short and longer-term effects of the Endobarrier™~     implantation on insulin resistance and beta-cell function assessed by repeated Botnia clamps.~     In addition changes in gut peptides and gut permeability after implantation of a removable~     duodeno-jejunal bypass device to induce diabetes remission in obese subjects with~     sub-optimally controlled type 2 diabetes mellitus will be determined. Further changes in body~     weight and body composition, the change in global cardiovascular risk from baseline to 12~     months, estimated using the UKPDS risk engine will be recorded.~   "
60902|NCT02769715|"~     Removable partial dentures (RPDs) are traditionally fabricated by lost-wax casting technique,~     a time-consuming and very laborious manual technique. Recently, fabricating removable partial~     dentures using computer designing and laser sintering techniques have been introduced. The~     purpose of this study was to evaluate the patient satisfaction with new computer-generated~     removable partial dentures and compare it to the traditional removable partial dentures.~   "
60919|NCT02769494|"~     This study aims at evaluating efficacy and safety of topical using Mesalazine~     Sustained-Release Tablets in in the treatment of oral ulcers in patients with Crohn's~     disease.~   "
60920|NCT02769481|"~     The purpose of this study is to investigate the effect of bexagliflozin compared to~     glimepiride as an add-on therapy to metformin in lowering hemoglobin A1c (HbA1c) levels in~     subjects with type 2 diabetes mellitus (T2DM).~   "
60903|NCT02769702|"~     Uveitis is an acute or chronic inflammatory condition of unknown etiology. Although uveitis~     often responds adequately to topical corticosteroids, there are many patients for which this~     treatment is either inadequate or not tolerated. A patient with inadequate response to~     treatment would manifest uveitis activity by slit lamp examination determination of anterior~     chamber cellularity. Lack of tolerance of therapy commonly manifests as ocular hypertension~     (greater than 21 mmHg measured by tonometry)complicating chronic topical corticosteroid~     administration, leading to glaucoma and permanent visual loss. Moreover, systemic~     corticosteroids may be required at a dose unsafe for chronic administration. In these~     situations, an immunosuppressive medication is often added as a steroid-sparing agent. If~     and when there is clinical response to the added immunosuppressive, the oral and/or topical~     corticosteroid dose can be reduced or eliminated to avoid toxicity.~      There are several reasons for believing that Acthar might be beneficial in the treatment of~     uveitis patients. In addition to increasing adrenal production or cortisol, Acthar has~     another important mechanisms of action mediated by its binding of melanocortin receptors.~     Melanocortin down-regulates activity of B and T lymphocytes, monocytes and macrophages. In~     animal studies, melanocortin peptides down-regulate T helper cells, up-regulate T Regulatory~     cells, and decrease B lymphocyte production of B Lymphocyte Stimulator. In macrophages, there~     is down-regulation of IL-1, IL-2, INF gamma, TNF alpha, nitric oxide and adhesion molecules.~     In other cells, in addition to IL-10 upregulation (monocytes), there is down-regulation of~     VACM and ECAM (endothelial cells), prostaglandins (fibroblasts) and MCP-1 and RANTES (renal~     tubules).CNS mediation of systemic inflammation may also be down-regulated by melanocortin~     receptor binding by Acthar.~   "
60904|NCT02769689|"~     Progressive multifocal leukoencephalopathy (PML) is the most feared complication when~     natalizumab (NTZ) is used in the treatment of relapsing multiple sclerosis (MS). The risk of~     PML increases after 18 months of treatment. When switching from NTZ to another disease~     modifying treatment (DMT) in these MS patients with an active disease, there is a high risk~     of inflammatory reactivation. Nonetheless, a washout period of several weeks is necessary~     before initiating a new DMT.~      The primary purpose of this protocol is to investigate the impact of high dose of oral~     methylprednisolone, given once a month during the washout period between NTZ and Fingolimod~     (FTY).~   "
60905|NCT02769676|"~     The current postpartum care model of a single visit 4-6 weeks after delivery does not~     optimally address contraceptive needs. By this visit, many women have resumed sexual~     activity, potentially putting them at risk for unintended and rapid repeat pregnancy. In~     addition, many women with pregnancy-related Medicaid lose insurance coverage at this time,~     making it difficult to obtain long-acting reversible contraception (LARC) if desired.~     Therefore, an earlier postpartum visit may remove barriers to improve access to LARC thereby,~     reducing unintended and rapid repeat pregnancy. Our primary objective is to determine whether~     an additional 3-week postpartum visit, compared to usual postpartum care, will affect the~     initiation of LARC by 6 weeks postpartum.~   "
60906|NCT02769663|"~     The study assesses cognitive complaints in newly diagnosed patients with obstructive sleep~     apnea with no medical-comorbity affecting cognition. Cognitive complaints will be compared to~     healthy controls matched on age, sex and educational level. Factors related to cognitive~     complaints will also be assessed, including anxiety and depressive symptoms, complaints of~     fatigue and sleepiness, quality of life, psychological coping strategies and objective~     measures of cognition. Patients starting treatment for sleep apnea (continuous positive~     airway pressure or mandibular repositioning device) will be reassessed on all measures after~     6 months of treatment to study the impact of treatment as usual on cognitive complaints and~     its related factors.~   "
60907|NCT02769650|"~     The hypothesis of this study is that Stress-MRI is a clinically significant method of~     myocardial perfusion assessment after coronary angioplasty with stenting of right coronary~     artery (RCA) chronic total occlusion (CTO) is performed.~   "
60908|NCT02769637|"~     Mucus in the airways of patients with CF represents an area for bacteria proliferation,~     microbial infection and inflammation. Similar to the lung, the esophagus provides an~     environment for bacterial to grow. The overall goal of this proposal is to characterize the~     esophageal microbiota of children with CF that are treated or untreated with acid blockade~     medication and to measure its possible impact on respiratory disease to develop novel~     treatment strategies.~   "
60909|NCT02769624|"~     In this pilot study investigators propose to explore the effects of a locally delivered~     inhaled pulmonary vasodilator (inhaled treprostinil) on exercise performance, pulmonary blood~     flow, venous pressure response and vascular function in stable Fontan patients. Investigators~     will also assess the effects of resting and acute rises in exercise induced systemic venous~     pressure on liver stiffness and will also assess whether treprostinil will attenuate the~     acute stiffness increase that investigators expect to see. This will be a prospective,~     randomized, double-blinded placebo controlled, crossover trial. Following recruitment and~     informed consent, each participant will undergo three study visits, including baseline~     testing (visit 1), followed by two sets of exercise and vascular function tests (visit 2 and~     visit 3) at CCHMC. Twenty-six patients will be enrolled in this study.~   "
60910|NCT02769611|"~     This study evaluates the effect of ruboxistaurin for its safety, tolerability, and~     effectiveness in treating adult patients with heart failure. Patients will receive 1 dose of~     oral ruboxistaurin.~   "
60911|NCT02769598|"~     Fighting against the pain caused by the disease or by the diagnostic and therapeutic~     procedures for children is a daily and essential concern of health care in the pediatric~     sector. The quantification of pain is needed to effectively adjust analgesic therapy while~     limiting the side effects of treatment. Nowadays many scales are validated for children, but~     they are based on one-off measures and hetero assessments are often subjective and dependent~     on many factors including the presence of staff to children's sides.~      Recent developments in the analysis of the cardiac signal in real time under the influence of~     autonomic control, have led to the development of a new painful stress quantification index.~     A monitor has recently been developed and provides an index of nociception and analgesia (ANI~     index). The validation of this nociception index has not been validated for pediatric care in~     a sector where particular attention is given to control pain.~      The main purpose of this study is to show the consistency of the index compared to a~     validated pain scale and used routinely in non-sedated children hospitalized in pediatric~     intensive care units. The caregiver will have the opportunity to fine tune the effective~     treatment.~   "
60912|NCT02769585|"~     Randomized study evaluating self-hypnosis versus certified diabetes educator training for~     weight loss in type 2 diabetics.~   "
60913|NCT02769572|"~     This is a multicenter , double-blinded, double-dummy, randomized controlled clinical trial to~     evaluate the efficacy of moxibustion for osteoarthritis of the knee.~   "
60914|NCT02769559|"~     The data gathered here will be used to evaluate the efficacy and safety of the mammary~     reduction in patients with macromastia.~   "
60921|NCT02769468|"~     The aim of the study is to compare the effect of 3 different skin temperature placement probe~     in the case room on the admission temperature to the NICU in preterm infants. The authors aim~     to evaluate which placement results in more preterm in the acceptable range (36.5-37 °C).~   "
60922|NCT02769455|"~     Front-Of-Pack (FOP) nutrition labelling, providing simplified information on nutritional~     content at a glance, in order to help consumer make informed choices, has been identified as~     of major interest by public health specialists of many countries. French health authorities~     are currently considering the endorsement of a FOP nutrition label, but no specific format~     has yet been determined. A more simplified FOP nutrition label has been put forward in~     France, the 5-Colour Nutrition Label (5-CNL). Recent data suggests that the 5-CNL FOP label~     is well perceived and understood by consumers. The introduction of a FOP nutrition labelling~     system has been identified as challenging in certain population groups, due to their lower~     level of nutrition knowledge and unhealthier diets.~      The aim of the investigators is to evaluate the impact of FOP nutrition labels on the~     nutritional quality of the shopping cart in an online experimental supermarket in various~     nutritionally at-risk populations. Two FOP systems will be tested to a control situation~     without FOP labelling: the Reference Intakes (RI), currently in use by some manufacturers and~     present in a portion of food products sold in France, and the 5-Colour Nutrition Label~     (5-CNL).~      Three 3 arm parallel arm randomized trials are designed, each targeting a specific~     population. The methodology and interventions are identical across trials. Trials will be~     conducted in: 1) Working adults between 30-50 years old with low income, 2) Students and 3)~     Older subjects with identified chronic diseases. The intervention consists in the application~     of FOP nutrition labels on all food products, either the RI label, currently in use in some~     products in France, and the 5-CNL label. A control situation with no FOP will also be used.~     Participants will be asked to perform a shopping session in an experimental online~     supermarket, in one of the three experimental conditions described. The main outcome will be~     the overall nutritional quality of the shopping cart, assessed using the mean Food Standards~     Agency Nutrient profiling system score of the items in the shopping cart.~   "
60923|NCT02769442|"~     A randomized prospective comparison of two FDA approved intravenous catheters in the~     emergency department setting. The Terumo SurFlash Plus offers novel technologies that promise~     to increase intravenous access success rates and decrease blood contamination of the~     insertion site. This study would analyze these properties in our busy, urban emergency~     department setting where time and safety of intravenous access are most critical.~   "
60924|NCT02769429|"~     This study will answer the question whether there is a difference in the effects and~     complication rates of ultrasound guided continuous interscalene block (CISB) and nerve~     stimulation-guided continuous cervical paravertebral block (CCPVB). The aim of this study is~     to evaluate the differences in efficacy and side effects - if any.~   "
60925|NCT02769416|"~     The NCTT is a prospective, multicenter, observational research network for subjects with~     chronic spinal cord and/or chronic traumatic brain injury.~   "
60926|NCT02769403|"~     The purpose of this research study is to determine if using HeartMath's biofeedback with~     emWave Pro daily mindfulness practice: is a practical and effective intervention to improve~     job satisfaction and performance of physicians, advance practice clinicians, and nurses;~     improves patient satisfaction; and affects resting blood pressure and heart rate when~     comparing baseline to follow-up measures.~   "
60927|NCT02769390|"~     The use of increasing doses of clonidine ssociated to bupivacaine in caudal epidural block~     provides better postoperative analgesia compared whit analgesia provide by bupivacaine alone~      It is a randomized, double blind study, involving 80 children with ages from 1 to 10 years~     old, following eletive hypospadias surgery, under general anesthesia and caudal epidural~     block . The patients will be divided into 4 groups: bupivacaine alone, bupivacaine plus~     clonidine 1mcg/kg, bupivacaine plus clonidine 2 mcg/kg, bupivacaine plus clonidine 3 mg/kg.~     The peroperative consumption of anesthetics gases, heart rate and arterial blood pressure~     will be recorded. Postoperative pain will be evaluated by using FLACC scale ( faces , legs,~     activity , cry , consolability ) . Requiriments for supplementary postoperative analgesia at~     24 h will be avaiable.~   "
60928|NCT02769377|"~     To determine if glucometer combined with mobile-phone based data transfer system would be~     useful for patient diabetes to manage their glycemic control.~   "
60929|NCT02769364|"~     Decision-making for treatment of metastatic breast cancer after the second line of~     chemotherapy was limited by the lack of established predictive factors of benefit for further~     chemotherapy regimens. Eribulin has emerged as the only single agent demonstrating an overall~     survival improvement in the third-line setting or beyond. The purpose of this study was to~     define the clinical profile of metastatic breast cancer participants achieving long-term~     benefit from chemotherapy with eribulin in the third-line setting or beyond.~   "
60930|NCT02769351|"~     In patients with advanced volume overload, minimally invasive ultrafiltration treatment in~     the acute phase can have a positive effect on clinical outcome. The aim is to collect~     treatment data in the context of a prospective registry of the safety and performance of~     minimally invasive ultrafiltration. The data will be recorded via an electronic case report~     form (eCRF); the eCRF runs on a server located in Germany and complies with current data~     protection regulations. It is intended to include about 300-500 patients with advanced volume~     overload at a minimum of 10 sites. In addition, data on a disease management programme~     (in-body measurement and home monitoring) will be recorded in up to 40 of these patients. The~     treatment data from each patient will be recorded over 12 months. An interim analysis will be~     performed after 150 patients have been observed for 6 months. The knowledge about~     ultrafiltration in volume overload obtained from the registry, in some cases in combination~     with a disease management programme, is intended to improve the body of evidence. In~     addition, the data will be used for hypothesis generation.~   "
60931|NCT02769338|"~     This program will seek to implement a quality improvement program to improve the care of~     Veterans with TIA or minor stroke at 6 Veteran Health Administration Hospitals. The~     investigators will evaluate the implementation and effectiveness of the quality improvement~     program.~   "
60932|NCT02769325|"~     This is a double blinded, randomised controlled trial that will compare atropine to placebo~     for postoperative pain in laparoscopic gynaecological surgery~   "
60933|NCT02769312|"~     The purpose of the proposed study is to evaluate initial feasibility and efficacy of Theta~     Burst Transcranial Magnetic Stimulation (TBS) as an adjunct treatment for Veterans with PTSD.~     Primary outcomes measures include a feasibility of TBS procedures, with secondary outcome~     measures focusing on changes in PTSD symptom severity and quality of life and~     social/occupation functioning.~   "
60934|NCT02769299|"~     The overall objective of this proposal is to determine the utility of sensitive imaging and~     biomarker measures in detecting subclinical cardiotoxicity across a spectrum of radiation~     doses to the heart. We will focus specifically on patients receiving photon or proton chest~     radiotherapy. Our broad working hypothesis is that RT induces early, subclinical CV injury,~     as evidenced by cardiomyocyte inflammation and necrosis, and worsening CV function.~   "
60936|NCT02769273|"~     Prospective, international, multi-center, single arm, observational study to continue to~     assess the treatment by the Stellarex™ OTW Drug-coated Angioplasty Balloon in superficial~     femoral and/or popliteal arteries according to the Instructions for Use in a broad,~     real-world, claudicant or ischemic rest pain patients population per the institution's~     standard practice.~   "
60937|NCT02769260|"~     The purpose of this study is to determine in situ the bacterial viability, thickness and~     bacterial diversity of a biofilm formed on different substrates in comparison to a naturally~     tooth-formed oral biofilm. In addition, it will be evaluated whether the restraint of oral~     hygiene measures may influence the development of the PL-Biofilm.~   "
60938|NCT02769247|"~     To compare the efficacy of intrauterine lidocaine and oral naproxen sodium on discomfort and~     pain of patients undergoing intrauterine device insertion.~   "
60939|NCT02769234|"~     In a previous study, NCT00582127, two age-matched cohorts, one clinically diagnosed with mild~     Alzheimer's disease and the other healthy controls, were tested with a hand-held EEG/ERP~     system to determine if the cohorts could be discriminated using the EEG/ERP measures. This~     study proposes to retest the AD cohort 18-60 months after their first test to characterize~     the change in EEG/ERP measures correlated with the longitudinal change in neuropsychological~     testing.~   "
60940|NCT02769221|"~     This study compare the intubation success rate between video laryngoscope and rigid video~     stylet in cervical spine surgery patients. Half of patients will receive endotracheal~     intubation by video laryngscope, other half of patients will receive endotracheal intubation~     by rigid video laryngoscope.~   "
60941|NCT02769208|"~     The purpose of this study is to evaluate whether two different central air purification~     technologies reduce air pollutant exposure and beneficially influence health as evaluated~     with a suite of biological markers related to cardiovascular and respiratory disease risk.~   "
60942|NCT02769195|"~     This study is a secondary, pooled analysis of two completed phase 3 clinical trials:~      (i) GSK-HGS1006-C1056 (BLISS-76): A Phase 3, Multi-Center, Randomized, Double-Blind,~     Placebo-Controlled, 76-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006,~     LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus~     Erythematosus (SLE); and,~      (ii) GSK-HGS1006-C1057 (BLISS-52): A Phase 3, Multi-Center, Randomized, Double-Blind,~     Placebo-Controlled, 52-Wk Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006,~     LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus~     Erythematosus (SLE)~      The study will assess the discriminant validity of a proposed measure of low disease activity~     (the Lupus Low Disease Activity State, LLDAS) in patients with SLE.~   "
60943|NCT02769182|"~     The main objective of this research is to develop and validate a technology-based solution~     that addresses the diminished mobility, increased fall risk and impaired cognitive function~     that are so common among older adults, enabling them to live longer successfully and~     independently.~   "
60944|NCT02769169|"~     The purpose of this study is to determine whether double-dose Ranibizumab are effective to~     regress the polyps and benefit to the visual outcome in the polypoidal choroidal vasculopathy~     (PCV).~   "
60945|NCT02769156|"~     This pilot and feasibility study is focusing on patients presenting with suspected~     malignancies of the lung and pleura who are considered to be good surgical candidates. The~     primary end-point of the study is to determine the sensitivity of OTL uptake and expression~     in identifying those lung and pleural nodules when excited by an imaging probe. There will be~     a single dose of 0.025 mg/kg for intravenous injection over approximately 60 minutes, two to~     three hours, prior to surgery.~   "
60946|NCT02769143|"~     Women in the postmenopausal period suffer hormonal changes that contribute to a number of~     negative factors to health, such as reduced bone mineral density and loss of muscle mass,~     which contribute to the increased incidence of falls and consequent risk of fractures. Among~     the possibilities to alleviate these symptoms are mainly drug treatment and the systematic~     practice of physical exercise. Exercise stands out for not offering adverse effects. One form~     of exercise that has been recently investigated is the whole body vibration, another form of~     exercise well accepted by the population is the Pilates method.~      Taking into account the lack of literature on the benefits of vibration training; and also~     the Pilates method on bone mineral density, muscle strength, flexibility, postural balance,~     fear of falling and the quality of life of postmenopausal women, explains the importance of~     this work.~   "
60947|NCT02769130|"~     This pilot study evaluates the safety and feasibility of losartan in pediatric patients with~     pulmonary vein stenosis.~      It is an open label single arm interventional study. The patient population involves~     pediatric patients with stenosis in 2 or more pulmonary veins. Patients will be given~     losartan for 1 year. Outcomes include measures of safety/adverse events and progression of~     pulmonary vein stenosis.~   "
60948|NCT02769117|"~     The purpose of this study is to evaluate sequential fracture healing with radius/ulna~     fractures or clavicle fractures and compare ultrasound to radiographs.~   "
60949|NCT02769104|"~     The investigators designed this study to investigate the effect of aromatase inhibitors (AI)~     plus chemotherapy versus chemotherapy as neoadjuvant treatment in postmenopausal hormone~     receptor-positive breast cancer.~   "
60950|NCT02769091|"~     The purpose of this study is to assess the effect of TEV-45478, as compared with placebo, on~     liver health and liver fat content in patients with T2DM who also have Nonalcoholic~     Steatohepatitis (NASH).~   "
60951|NCT02769078|"~     The overall objective of this proposal is to execute a real-world database analysis to~     evaluate hospital readmissions among hospitalized nonvalvular atrial fibrillation (NVAF)~     patients in the U.S.~   "
60952|NCT02769065|"~     The purpose of this study is to assess the safety, tolerability, and pharmacokinetic (PK) of~     TAK-071 when administered as single rising dose (SRD) and multiple rising dose (MRD) orally~     in healthy participants and participants with mild cognitive impairment (MCI) or mild~     Alzheimer disease (AD).~   "
60953|NCT02769052|"~     Objective: to evaluate the effectiveness of Transcutaneous Electrical Nerve Stimulation~     (TENS) self-applied for the treatment of pain and the impact of this therapy on biomechanics,~     quality of life and sexuality of women with deep endometriosis.~   "
62489|NCT02748954|"~     The main goal of this study was to compare the effect of a one-session unsupported Internet~     intervention on participants' clinical symptoms (depressive and anxiety symptoms) and related~     variables (mood, confidence and motivation).~   "
60954|NCT02769039|"~     Treatment resistant motor features, such as postural instability and freezing of gait are~     common in people with Parkinson's disease and major contributors to morbidity and mortality.~     This project will use sleep studies, quantitative motor assessments and magnetic resonance~     imaging to examine the relationship between abnormally increased muscle activity during rapid~     eye movement sleep and the development and progression of treatment-resistant postural~     instability and gait disturbances. Specifically, the investigators will test the hypothesis~     that anticipatory postural adjustments (weight and pressure shifts) during gait initiation~     are significantly reduced in people with Parkinson's disease who have abnormally elevated~     muscle activity during rapid eye movement (REM) sleep compared to individuals will~     Parkinson's disease whose REM sleep muscle activity is normal. In addition, the investigators~     will test the hypothesis that the level of RSWA at baseline is predictive of measures of~     motor decline (postural stability and gait) and alterations in the structure and function of~     locomotor brainstem networks. Since sleep disorders can emerge years before a diagnosis of~     Parkinson's disease, establishment of a link between sleep and treatment-resistant posture~     and gait disorders will help identify individuals at risk of developing these disabling motor~     features of disease.~   "
60955|NCT02769026|"~     This multicenter study will validate a panel of serum, imaging, and clinical biomarkers to~     classify patient outcome early after out-of-hospital pediatric cardiac arrest. Results are~     expected to have a positive and immediate impact in advancing clinical care and outcomes for~     these children. This work will provide clinicians, families, and researchers with superior~     tools to assess the severity of brain injury early after resuscitation in order to know who~     is at risk of brain injury and may benefit from neuroprotective interventions, to monitor~     response to these interventions, to plan rehabilitation strategy, and to optimize the design~     of research studies that test novel interventions to improve neurological outcome after~     cardiac arrest.~   "
60956|NCT02769013|"~     Assessing the effect of neglected tropical diseases on Plasmodium falciparum transmission in~     an area of co endemicity.~   "
60957|NCT02769000|"~     Evaluate safety and toxicity/adverse events associated with delivery of low dose whole brain~     irradiation in patients with early Alzheimer's dementia according to the National Institute~     of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and~     Related Disorders Association (NINCDS-ADRDA) criteria.. As a secondary goal it will establish~     whether or not the intervention with low dose whole brain irradiation stabilizes or decreases~     cerebral amyloid deposits and whether these correlate with the recognized progression of~     Alzheimer's dementia. The investigators will also collect information from the FDG and~     Amyvid® PET Scans to determine if there is any correlation between neurocognitive/quality of~     life scores and changes in amyloid plaque size, number and location.~   "
60958|NCT02768987|"~     Physical inactivity occurs among 65% to 95% of youth with type 1 diabetes (T1D) and based~     upon limited evidence may contribute to the rapidly growing incidence of overweight among~     this population. The purpose of the present study is to pilot test a 12-week intensive~     lifestyle program for adolescents with overweight and T1D utilizing group exercise classes~     adapted for this population, supplemented with coping skills training and diabetes~     self-management education to address problem solving behaviors that limit their physical~     activity and weight control. Our primary aim is to evaluate the changes in physical activity~     adherence, anthropometrics, and self-management behaviors following this program among~     sedentary adolescents with T1D and overweight (n=25, OW) compared with sedentary adolescents~     with T1D and normal weight (n=25, NW). We hypothesize that the OW group will achieve improve~     physical activity adherence and anthropometrics to the same or greater extent as the NW group~     and previous Bright Bodies cohorts, and that these changes will correlate with improved~     exercise-related problem solving. Our secondary aim is to evaluate changes in adipocytokines~     and epigenetic factors related to the etiology of overweight/obesity following our physical~     activity intervention. We hypothesize changes in these biomarkers will correlate with changes~     in anthropometry variables and partially explain any differences in response between the~     groups and individuals should those occur.~   "
60959|NCT02768974|"~     This is a proof of concept, randomized, open label, 2-arm study of OPRX-106 in subjects with~     active mild to moderate ulcerative colitis. Eligible subjects will be enrolled and randomized~     to receive 2 mg or 8 mg of OPRX-106 administered orally, once daily for 8 weeks.~   "
60960|NCT02768961|"~     The objectives of this study are:~        1. To perform a systematic screening and evaluation of the prevalence of infection by~          hepatitis C virus (HCV), hepatitis B virus (HBV) and human immunodeficiency virus (HIV)~          in the prison population.~        2. To perform an adequate characterization of patients and the characteristics of HCV~          infection in this population.~        3. To evaluate the effectiveness and security in the prison population of an~          interferon-free antiviral regimen.~        4. To evaluate the impact of a strategy of systematic HCV treatment on the rates of~          persistent infection, reinfection and super-infection in a prison population, in the~          short, medium and long term.~   "
60961|NCT02768948|"~     The severity of the diabetic nephropathy is proportional to proteinuria rate and degree of~     renal interstitial fibrosis. Despite many treatments available today, diabetic nephropathy is~     responsible for a quarter of cases of end-stage renal disease (ESRD) requiring the use of~     renal replacement therapy or kidney transplantation. It develops as follows: chronic~     hyperglycemia of diabetes abyss renal glomeruli that allow proteins in the urine room. In~     response, the tubular epithelium produces monocyte chemoattractant protein-1 (MCP-1) that~     attracts monocytes circulating in the renal interstitium. Monocytes then differentiate into~     M1 or M2 macrophages. M1 macrophages increased MCP-1 production while M2 macrophages produce~     transforming growth factor beta (TGF-β) pro-fibrogenic. Renal fibrosis is negatively~     correlated with the glomerular filtration rate itself proportional to the number of nephrons.~     The decrease in the number of nephrons majorises secondarily proteinuria by the onset of~     focal segmental glomerulosclerosis lesions. Production of MCP-1 increases with the renal~     proteinuria because M1 macrophages earning kidneys reinforce the production of MCP-1, and~     fibrosis worsens because M2 macrophages infiltrate in turn kidneys and produce TGF -β.~      A way of limiting renal fibrosis would be to decrease renal monocytic infiltration by~     promoting the differentiation of monocytes towards macrophages M2. Although more numerous, M2~     macrophages no longer benefit the kidneys because the decline of M1 macrophages decrease~     renal MCP-1 production. Ex vivo IL1-β orients the differentiation of monocytes towards~     macrophages M1 and IL-4 to M2. By cons in vivo, the differentiating factors are poorly known.~     It is remarkable that metformin and telmisartan increase M2 macrophages M1 macrophages and~     decrease, respectively, in humans and mice. Moreover, telmisartan reduces proteinuria more~     than losartan in diabetic nephropathy in humans and Metformin decreases the amount of TGF-β~     intra-renal mice. This effect of telmisartan is independent of the type 1 receptor of~     angiotensin II (AT1R) since it is not obtained with losartan.~      Telmisartan is a partial agonist of peroxisome proliferator-activated receptor gamma~     (PPARgamma), the working assumption is that telmisartan fosters the transition of monocytes~     to macrophages M2 form, and limit the recruitment of more monocytes in the kidneys and~     therefore proteinuria and renal fibrosis. To show this, it will be compared the ability of~     monocytes to differentiate ex vivo in M1 or M2 macrophages in diabetic nephropathy patients~     treated with losartan or telmisartan then it will characterize the role of PPARgamma in the~     monocyte / macrophage transition. Finally, it will be compared the urinary excretion of amino~     terminal propeptide of procollagen type 3 (PIIINP), considered a marker of renal fibrosis in~     patients receiving losartan or telmisartan.~   "
60963|NCT02768922|"~     This study aims at contributing with scientific evidence to the field of aphasia~     telerehabilitation. In Norway today, there is an unmet need for language training in post~     stroke aphasia and not all patients are offered language training. Early start of aphasia~     rehabilitation and satisfying intensity do not seem to be standard clinical practice.~     Language training by telemedicine could improve this situation, and this study seeks to~     answer the question whether aphasia rehabilitation delivered by videoconference can improve~     language function in aphasia post stroke.~   "
60964|NCT02768909|"~     Determine the diagnostic accuracy for pulmonary tuberculosis in adults of the E-Nose in~     Venezuela.~   "
60965|NCT02768896|"~     Voltage fluctuation as a result of brain activity will be recorded into the computer using an~     EEG device.~   "
60966|NCT02768883|"~     The immediate goal of the Imperial County CER Asthma project is to identify strategies to~     improve asthma control among children 0-17 years old and the asthma control behaviors of~     their families, their health care providers, and the communities in which they live. Our~     long-term goal is to improve the quality of life of children with asthma and potentially~     reduce families' economic and social burdens of uncontrolled asthma~   "
60967|NCT02768870|"~     The primary objective of this study is to evaluate the safety and performance of the Harpoon~     Medical device in patients with degenerative Mitral Regurgitation.~   "
60968|NCT02768857|"~     This study evaluated the effects of an integrated program of touch-observation and task-based~     mirror therapy on sensorimotor function in nerve injury patients. Before the return of~     protective sense (Value of Semmes-Weinstein monofilament test > 4.31), half of the~     participants received 15 minutes of mirror therapy program, followed by 20 minutes of regular~     hand therapy and 20 minutes of physiotherapy.While the other half received 15 minutes~     protective sensory reeducation programs, 20 minutes of regular hand therapy and 20 minutes of~     physiotherapy in each treatment session. Once the patients had regained the protective sense~     (Value of Semmes-Weinstein monofilament test < 4.31), the discriminative sensory reeducation~     program was started for the participants in both groups. The hypothesis was that using the~     mirror therapy for sensorimotor reeducation in the early phase after nerve repair would yield~     better results with regard to the returning of sensation, sensorimotor control ability and~     hand function than using a classical reeducation program alone.~   "
60969|NCT02768844|"~     The overall purpose of this project is to to quantify the physiology of neonatal drug~     withdrawal and develop non-pharmacological techniques to help improve the therapeutic~     management of Neonatal Abstinence Syndrome (NAS).~   "
60970|NCT02768831|"~     In the past 5 years cuffed endotracheal tubes (ETT) have become the standard of care in~     pediatrics. However, hyperinflation of the cuff can compromise the tracheal mucosal perfusion~     while an inadequate seal may impact ventilation and potentially increase the risk of~     aspiration. Hence, the goal after placement of a cuffed ETT is to create a safe and effective~     tracheal seal. The two ways to measure that are to hold CPAP while listening for an audible~     leak and measuring the difference between the inspired and expired tidal volumes (TV). This~     is a prospective study to compare these two methods used to create a tracheal seal and~     measure the intracuff pressure after a satisfactory tracheal seal is established.~   "
60971|NCT02768818|"~     The investigators aimed at evaluating the effectiveness of probiotics ingestion in changing~     maternal microbiota and preventing gestational diabetes in overweight and obese women.~      To achieve these goals, obese (BMI> 30 kg/m^2) or overweight (BMI> 25 kg/m^2) pregnant women~     with risk factors were enrolled in the study and randomized to the supplementation with the~     probiotic VIVOMIXX® or with placebo.~      The endpoints of this study are to evaluate if the dietary supplementation with the probiotic~     VIVOMIXX® modifies the maternal fecal microbiota (bifidobacteria and lactobacilli) and~     related enzymatic activity (alkaline sphingomyelinase and alkaline phosphatase), and if this~     if this is linked to an improvement of the intermediate metabolism (positive Oral Glucose~     Tolerance Test at 24-26 weeks).~   "
60972|NCT02768805|"~     This Phase 2 Quadrivalent VLP Vaccine study is intended to replicate and extend the~     immunogenicity and safety results obtained in earlier Phase 1-2 and Phase 2 studies. The~     study is being conducted to demonstrate that the immunogenicity profile of the Quadrivalent~     VLP Vaccine meets the US Center for Biologics Evaluation and Research (CBER) licensure~     criteria. The study will also help to define the optimal dose, establish potential~     competitive advantages, and support the design of future studies.~   "
60973|NCT02768792|"~     Rationale:The purpose of this research study is to test the effectiveness of the standard~     high dose cytarabine (HiDAC) on days 1 through 5 followed by a single dose of pembrolizumab~     on day 14 as induction therapy in patients with relapsed and refractory acute myeloid~     leukemia (AML). Patients who achieve a response to treatment will continue on the study drug~     (pembrolizumab) every 3 weeks for up to 2 years maintenance therapy.~      Purpose:This is a study about a new investigative drug, pembrolizumab (MK-3475) that is being~     studied in a clinical research trial together with standard chemotherapy (HiDAC) in relapsed~     and refractory AML. The study will also explore the association between potential immune~     biomarkers and clinical outcomes with pembrolizumab; therefore all patients will have blood~     and bone marrow samples collected before and after treatment to determine the dynamic nature~     of immune signatures pre and post-treatment.~   "
60974|NCT02768779|"~     Hair samples from subjects on antiretroviral therapy, both HIV- and HIV+ patients with HIV~     RNA <50copies/mL for >6 months will be analyzed to investigate the influence of race, hair~     color and hair treatment on ARV response.~   "
60975|NCT02768766|"~     The purpose of this study is to find out what effects, good and/or bad, intermittent dosing~     of the drug Selumetinib will have on subjects with uveal melanoma. Selumetinib is a drug that~     blocks (or turns off) methyl ethyl ketone (MEK), a protein activated in some uveal melanoma~     cells. Selumetinib is a MEK inhibitor. Blocking MEK may stop the cancer from growing.~   "
60976|NCT02768753|"~     The purpose of this study is to compare the therapeutic effects between the axillary~     bilateral-breast approach (ABBA) and bilateral axillo-breast approach (BABA) for robotic~     thyroidectomy.To explore the efficacy, safety, cosmetic results and clinical value by the two~     approaches.~   "
61084|NCT02767349|"~     An open-label study of the pharmacokinetics (PK) and safety of MNK-155 in postsurgical~     adolescent subjects aged 12 to 17 years with moderate to severe acute pain. The study will~     assess the safety of administering multiple doses of MNK-155 in this population.~   "
60977|NCT02768740|"~     We performed a multicenter, prospective, randomized, double-blind, pilot study in four adult~     medical intensive care units. Patients presenting septic shock were rapidly administered one~     of two regimens of hydrocortisone, either a 50-mg intravenous bolus every six hours during~     seven days (200-mg group) or a 100-mg initial bolus followed by a continuous infusion of 300~     mg daily for five days (300-mg group). Hydrocortisone was stopped abruptly at the end of~     treatment.~   "
60978|NCT02768727|"~     The dual objectives of this study are to determine if the phenomenon of neural inertia is~     present in humans and to determine whether the order of neurocognitive function is invariant~     among anesthetic agents. This study will enroll 24 healthy volunteers, ages 20-40 years, who~     will receive xenon gas (concentrations ranging from 0% to 60%) delivered via inhaled route~     through the ENHANCER 3000.~   "
60979|NCT02768714|"~     This is a Phase III, randomised, assessor-blind, parallel group, multicentre trial. At least~     180 adult subjects with high-risk Stage II or Stage III / IV breast cancer will be randomised~     (1:1) to receive either Eurofarma's pegfilgrastim (n = 90) or Neulastim (n = 90) in 8 to 10~     sites in Brazil. Subjects will undergo a maximum of 4 cycles of myelosuppressive chemotherapy~     (21 days per cycle).~   "
60980|NCT02768701|"~     This phase II, single-arm, multicenter study will evaluate pembrolizumab therapy in patients~     with advanced triple-negative breast cancer (TNBC) who have received at least one prior line~     of therapy.~   "
60981|NCT02768688|"~     This study is to assess the effect of dexmedetomidine anesthesia on glymphatic flow in 5~     healthy human subjects as visualized by diffusion tensor MRI. The study is designed to~     measure clinically established, safe imaging of DTI and cerebral blood flow at baseline,~     during a continuous intravenous infusion of dexmedetomidine at doses designed to produce~     anesthesia-induced unconsciousness to simulate natural sleep, and again on return to~     wakefulness.~   "
60982|NCT02768675|"~     The LOADPRO Study is an intra-operative, non-significant risk (NSR) case series feasibility~     assessment of the Intellirod LOADPRO™ System measuring spinal rod strain in long spinal~     kyphotic corrective constructs.~   "
60983|NCT02768662|"~     This is an open-label extension study of a single intratympanic injection of OTO-104 given~     every 3 months for a total of 2 injections. Subjects must have completed either Otonomy study~     104-201403 (1-Year, Phase 2, Safety Study of OTO-104) or 104-201508 (Phase 3 Study of~     OTO-104) in order to be eligible for this open-label extension study.~   "
60984|NCT02768649|"~     The purpose of this study was to assess the safety and tolerability of injections of RBP-7000~     in subjects with stable schizophrenia~   "
60985|NCT02768636|"~     Heart rate variability can represent physiological and psychological levels via sympathetic~     and parasympathetic variables on autonomic nervous function. Omega-3 has shown that it can~     effect on physiological and psychological with many good results. The pathways to explain~     about its effect had been studied in many contexts. Effect to autonomic nervous function by~     Omega-3 is our interesting question.~   "
60986|NCT02768623|"~     Asthma is one of the most common chronic health conditions, affecting 900,000 Ontarians, 2.4~     million Canadians and over 300 million people worldwide. Unlike most other chronic diseases,~     asthma affects a significant proportion of children - an estimated 21% in Ontario. Asthma is~     also the leading cause of hospitalization for children in Canada and is a significant cause~     of school and work absenteeism. Though asthma is generally considered a chronic disease, it~     can be fatal in some instances - in 2009, an estimated 91 Ontarians died of this condition.~     Effective management of asthma can prevent exacerbation and more severe negative health~     consequences. In fact, estimates show that over 80% of the asthma-related deaths could be~     prevented through proper education. However, evidence also shows that over 55% of patients~     with moderate to severe asthma do not have their asthma symptoms under control, despite~     regular doctor visits. Less than a third (31%) of asthma patients report receiving an asthma~     action plan from their physicians, although such plans are associated with fewer ER visits,~     lower hospitalization rates and improved lung function. Hence, there is a clear opportunity~     to improve the management of asthma and reduce the incidence of related complications.~      Given the scientific evidence of pharmacists effect on asthma management there is a strong~     rationale for introducing an asthma-specific pharmacist-led intervention for Ontarians~     suffering from this chronic disease. However, the implementation of such a program should be~     preceded by a pilot test to ensure that the program parameters are optimized to drive~     improved patient outcomes and maximum quality of service. The primary goals of this research~     project are to examine the impact of a pharmacist led asthma management intervention on~     patient health outcomes and to determine the optimum program structure to ensure quality of~     service delivery.~      This study employs a mixed-methods study design. Investigators will begin with a cluster~     randomized controlled trial and end with exit interviews.This study will consist of a~     prospective, randomized controlled trial conducted in the community setting. A total of 12~     pharmacies across the Greater Toronto Region will be recruited for this study. Each of these~     pharmacies will be randomly assigned in a 1:1 ratio to either the intervention group or the~     control group. All data will be analyzed using statistical software. Significance level will~     be set at 0.05. Pharmacy level descriptive characteristics, including mean and standard~     deviation for the number of patients will be reported. There is a low perceived risk for this~     study; however, the investigators will take every precaution to ensure this study is~     conducted in an ethical manner, including protecting patient confidentiality and anonymity.~   "
60987|NCT02768610|"~     Background: Dexmedetomidine is an alpha 2 adrenergic agonist with sedative, anxiolytic, and~     analgesic properties. This study was designed to evaluate the inhibitory effects of~     preoperative 0.5 μg/kg dexmedetomidine on hemodynamic responses caused by endotracheal~     intubation in elderly patients being treated for hypertension.~      Methods: Forty elderly (≥ 65 years) treated-hypertensive patients of American Society of~     Anesthesiologists physical status II undergoing elective noncardiac surgery were randomly and~     assigned to two groups. Group C received normal saline and group D received 0.5 μg/kg~     dexmedetomidine intravenously over 10 min just before endotracheal intubation. Systolic blood~     pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) and heart rate~     (HR) were recorded preoperatively at ward, immediately after study drug administration, and~     at 1, 3, and 5 minutes after endotracheal intubation.~   "
60988|NCT02768597|"~     The study will compare the outcome of primary reverse shoulder arthroplasty using the Stryker~     ReUnion System with implantation of either a large (40 mm) or a small (36 mm) glenosphere~     with either a +2 mm or a +6 mm offset.~   "
60989|NCT02768584|"~     Clarify the determinants of the construction of a Therapeutic Alliance (AT) between~     paramedical staff (nurses and caregivers ) and adult patients in a functional unit of~     full-time general psychiatric Whether the quality of Therapeutic Alliance influences the~     continued support outpatient , after completion of full-time hospitalization.~   "
61000|NCT02768441|"~     The pharmacokinetics of 10 to 12 individuals receiving 60 mg of sustained release~     dexamphetamine will be studied. These individuals have received this medication before in a~     previous trial where the pharmacodynamics were investigated. This trial will last 5~     consecutive days during which blood samples will be drawn for pharmacokinetics analyses.~     Dried blood spots will also be collected for the clinical validation of the bioanalytical~     method wherein these are used.~   "
60990|NCT02768571|"~     This study, E-COMPASSII is a phase IV clinical trial designed as a multicenter, randomized,~     double-blind, placebo-controlled, parallel-group study. This study will enroll 80 subacute~     stroke patients with severe motor involvement. Primary objective is to demonstrate the~     efficacy of porcine brain peptide to improve motor recovery measured by the improvement ratio~     of Fugl-Meyer assessment ((score of FMA after 3 weeks - score of FMA at baseline) / score of~     FMA at baseline) in patients with subacute stroke. Secondary objectives are to evaluate the~     safety profile of cerebrolysin and to test the hypothesis that subacute stroke patients with~     severe motor involvement randomized to administration of Cerebrolysin combined with~     rehabilitation for 3 weeks show better outcome on global function (Korean version Modified~     Barthel Index, K-MBI), severity of stroke (National Institute of Health Stroke Scale, NIHSS),~     cognitive function (Korean Version of Mini-Mental State Exam, K-MMSE; Korean version Montreal~     Cognitive Assessment, K-MoCA), upper limb function (Action Research Arm Test, ARAT; Box and~     block test, B&B) and neuroplasticity measure (resting-state functional MRI(rsfMRI), diffusion~     tensor image(DTI), and motor evoked potential(MEP)) at 3 months after stroke.~   "
60991|NCT02768558|"~     Patients with Stage III unresectable non-small cell lung cancer will receive thoracic~     radiation, cisplatin and etoposide followed by nivolumab or placebo given every 2 weeks for a~     year.~   "
60992|NCT02768545|"~     NPC1L1 is a key transporter in the enterohepatic cycle of cholesterol. Initial in vitro and~     in vivo data show that blocking this receptor with ezetimibe results in delaying infection in~     these models. The investigators hypothesize that HCV has an enterohepatic cycle, being~     secreted in bile and reabsorbed either in the canalicular membrane or in the intestine by~     association with NPC1L1, following a path similar to the cycle of cholesterol in humans. To~     prove this hypothesis the investigators propose to assess the effect of ezetimibe treatment~     in HCV infected individuals undergoing liver transplantation to avoid or delay HCV infection.~     For this purpose, the investigators propose to administrate ezetimibe 10 mg/d for 12 weeks to~     12 patients with chronic hepatitis C infection listed for a liver transplantation.~   "
60993|NCT02768532|"~     Vedolizumab (VDZ) is a monoclonal antibody which has shown its efficacy in Crohn's disease by~     inducing and maintaining clinical response/remission. The French marketing authorization was~     obtained for Crohn's disease in patients in failure with anti-TNF (Tumor Necrosis Factor)~     agents.~      For Crohn's disease patients treated with vedolizumab, a strong association between~     vedolizumab serum levels and clinical response to induction and maintenance was demonstrated~     by anterior studies.~      It could be of paramount interest to early identify Crohn's Disease patients under~     vedolizumab who will be responders to vedolizumab induction and to identify those who will~     achieve clinical remission under maintenance therapy with vedolizumab.~      Researchers decided to assess the clinical response to vedolizumab induction at week 10. For~     clinically non-responders at week 10, an additional dose of 300 mg of vedolizumab will be~     infused at week 10 and then every four weeks.~   "
60994|NCT02768519|"~     The purpose of this study is to determine the indicative bioavailability of a single oral~     dose of OTS167, and to evaluate the effects of food on OTS167 pharmacokinetics (PK) after~     oral dosing.~      Eleven male and female healthy participants aged 45 years and over will be entered into this~     phase 1, single-centre, double-blind, randomised, cross-over study. The trial is designed to~     evaluate the bioavailability of OTS167, and the effects of food on pharmacokinetics (PK) of~     OTS167 when administered by the oral route. Correlative studies include evaluation of safety~     endpoints and examinations, and adverse events. This study involves 3 cohorts to evaluate the~     safety and tolerability of oral dosing from lower dose.~   "
60995|NCT02768506|"~     Patients with BMI over 40 or with BMI over 35 and comorbidities are offered SADI-S with a~     variable limb length between 250 cm and 300 cm or gastric bypass.~      Results on weight loss, comorbidities resolution, complications, re-operations, need of~     supplements are registered.~   "
60996|NCT02768493|"~     The recent study revealed that high-volume caudal block caused reduction in cerebral blood~     flow velocity and cerebral oxygenation. It was supposed to be associated with increased~     intracranial pressure. Ultrasonography of optic nerve sheath diameter shows a good level of~     diagnostic accuracy for detecting intracranial hypertension. The aim of this study is to~     evaluate the effect of caudal block on intracranial pressure in pediatric patients undergoing~     urologic surgery. Eighty patients, aged 6 months to 4 years, receiving caudal block before~     urologic surgery will be divided into high dose group (n=40) and low dose group (n=40).~     Randomly selected patients of the high dose group are given 1.5 ml/kg of 0.15% ropivacaine~     for caudal block. In contrast, patients in the low dose group are given 1.0 ml/kg of 0.15%~     ropivacaine for caudal block. The primary endpoint is the optic nerve sheath diameter after~     caudal block measured by optic nerve ultrasonography.~   "
60997|NCT02768480|"~     The study is a randomized clinical trial, controlled, open label that aimed to compare two~     groups after discharge of a tertiary care: type 2 diabetes patients followed exclusively by~     primary care (control group) and patients followed by primary care and supported by phone~     calls (intervention group).~   "
60998|NCT02768467|"~     Prior studies have been performed to understand the optimal way to minimize the morbidity~     rate of buccal mucosa. While some studies have reported primary closure to be inferior to~     healing by secondary intention, this appears to be true for large defects greater than 2 cm~     in width. For small defects for which the wound can be closed without tension, the most~     recent study has shown improved pain outcomes in the immediate post-operative setting,~     although no difference is seen long term whether or not the wound was primarily closed.~     However, for larger defects, standard practice is to allow delayed healing by secondary~     intention.~      The use of Alloderm graft placement for donor site coverage was first described in Armenakas'~     group. Alloderm is an acellular dermal lattice from human allograft skin. The only study to~     report the use of Alloderm failed to find a significant improvement in patient outcomes;~     however, very small defects were included in this study and the control group underwent~     primary closure, which has been shown to be inferior for large defects. Importantly, no~     increase in post-operative pain was noted, although there was some increased swelling~     reported. From experience, patients with moderate and large (>2 cm width) defects following~     buccal mucosa harvest benefit from Alloderm placement with decreased post-operative pain,~     more rapid resumption of normal diet and mouth function with no associated increase in~     morbidity of the procedure. This study aims to determine whether this is a reliable~     improvement in technique.~      This study will clarify how the cheek heals after the buccal mucosa is removed during~     reconstructive surgery. Subjects will be randomized to either receive tissue collagen matrix~     or no stitches after the surgery. Subjects will be evaluated up to six months to determine if~     the outcomes of the tissue matrix graft are better for the subject.~   "
60999|NCT02768454|"~     To study the outcome of antibiotics stewardship~   "
61001|NCT02768428|"~     Objective: To compare the effectiveness between Video and Handbook on providing knowledge of~     TACE.~      Study Design: A prospective, randomized, controlled trial.~   "
61004|NCT02768389|"~     Patients may participate in this research study if they have glioblastoma. (a brain tumor)~     that has come back after being treated. Standard treatment for this cancer is a chemotherapy~     drug called bevacizumab. This research study involves bevacizumab in combination with a~     special diet called the Modified Atkins Diet (MAD).~      The purpose of this study is to research if patients can stay on the MAD when it is added to~     the standard bevacizumab treatment.~   "
61005|NCT02768376|"~     In this study, the investigators will study spinal anesthesia for laparoscopic~     cholecystectomy in comparison to general anesthesia (GA) regarding patient satisfaction as a~     primary variable, intraoperative complications, postoperative analgesic requirements,~     postoperative nausea and vomiting, patient hospital stay (secondary variables).~   "
61006|NCT02768363|"~     The purpose of this study is to evaluate the effectiveness of ProstAtak® immunotherapy in~     patients undergoing active surveillance for localized prostate cancer. ProstAtak® involves~     the use of aglatimagene besadenovec (AdV-tk) to kill tumor cells and stimulate a cancer~     vaccine effect. Killing tumor cells in an immune stimulatory environment induces the body's~     immune system to detect and destroy cancer cells. ProstAtak® has been well tolerated in~     previous trials in patients with prostate cancer and other tumor types. Biochemical,~     pathologic and immune responses have been demonstrated in newly diagnosed and recurrent~     prostate cancer. The hypothesis is that ProstAtak can lead to improvement in the clinical~     outcome for patients with prostate cancer. Participants will be randomized to the ProstAtak®~     or control arm at a 2:1 ratio. Both arms receive standard of care active surveillance~     evaluations.~   "
61007|NCT02768350|"~     The purpose of this study include (1) To investigate the efficacy of ventilator~     hyperinflation technique to re-expand lung atelectasis on patients with critical trauma who~     intubated and mechanical ventilation in the intensive care unit, (2) To investigate the~     effectiveness of ventilator hyperinflation technique to improve airway clearance on patients~     with critical trauma in the intensive care unit, and (3) To explore the acute responses of~     ventilatory functions to ventilator hyperinflation technique on patients with critical trauma~     who intubated and mechanical ventilation in the intensive care unit.~   "
61008|NCT02768337|"~     Proof of principle phase 1b / randomised phase 2 study of afatinib penetration into cerebral~     metastases for patients undergoing neurosurgical resection, both with and without prior~     low-dose, targeted radiotherapy.~   "
61009|NCT02768324|"~     Sepsis is a life-threatening condition that arises when the body's response to infection~     injures its own tissues and organs. Common signs and symptoms include fever, increased heart~     rate, increased breathing rate, and confusion. Clinically, sepsis patients with diarrhea~     often result in a bad prognosis. Gut microbiota consists of a complex community of~     microorganisms that live in the digestive tracts of animals. The gut microbiota comprises the~     largest and most diverse reservoir of mutualistic microorganisms associated with animals. The~     aims of this study is to determin the effect of gut microbiota on the prognosis of Sepsis, by~     using 16s pyrosequencing, comparing the blood culture result.~   "
61010|NCT02768311|"~     Today, dentists tend to use rotary systems. Despite the increasing diversity of these systems~     as well as a few studies on the prevalence of pain after root canal treatment by rotary~     systems, And in particular, comparing the amount of pain after treatment, between systems~     RECIPROCAL AND FULL ROTATION single-file, the aim of this study was to evaluate the effect of~     applying canal preparation by the system, Neolix and WaveOne, on the prevalence of pain after~     endodontic treatments.~   "
61011|NCT02768298|"~     The purpose of the study is to determine the effect of LCZ696 vs. Enalapril on improvement of~     excercise capacity in patients with chronic heart failure with reduced ejection fraction~   "
61012|NCT02768285|"~     The purpose of this study is to determine whether maintaining an apical patency causes~     postoperative pain in posterior teeth with necrotic pulp and apical periodontitis.~   "
61013|NCT02768272|"~     The investigators have design a randomized double blind clinical trial to know the incidence~     of breaktrough pain (BP) in high-risk of BP parturients (nulliparous with early cervical~     dilation) comparing two epidural analgesic regimes: programed intermittent epidural boluses~     versus patient controlled epidural analgesia. The role of the epidural technique (epidural~     versus combined spinal-epidural) in the incidence of BP will be also evaluated.~   "
61014|NCT02768259|"~     -  Measuring the incidence and prevalence of PAH in Egyptian patients with different types~          of MCD~        -  Determination of survival & the risk factors of mortality.~   "
61015|NCT02768246|"~     Ventilation of a bearded patient with the commonly used face mask has low efficiency because~     of difficulties to achieve a tight seal around the mouth and nose.~      The purpose of this study is to evaluate the efficacy of a novel bag valve guedel adaptor~     (BVGA) that enables the direct connection of a bag valve device to a guedel - eliminating the~     need for a face mask.~   "
61016|NCT02768233|"~     The aim of this study is to evaluate the influence of personality profiles in patients with~     MOH and to evaluate the effect of a custom-made educational programme as an add-on to~     standard treatment as compared to standard treatment alone in MOH patients using a randomized~     controlled trial (RCT) design.~   "
61017|NCT02768220|"~     Single-center open-label multiple dose randomized two period cross-over study to examine~     Advanced Glycation End Product (AGE) levels in human subjects pre and post empagliflozin~     administration.~   "
61018|NCT02768207|"~     This is a single arm, multicenter, open label, and non-randomized clinical study on adult~     participants with unresectable or metastatic melanoma. The study will be conducted in two~     phases. Pre-screening phase will assess the BRAF V600 mutation in a new mutation analysis~     triggered by a mutant plasma cfDNA test result. Treatment phase will assess the clinical~     outcome for the participants treated with vemurafenib plus cobimetinib. The length of the~     study will be approximately 38 months.~   "
61019|NCT02768194|"~     This will be a single centre, single blind, randomized, three treatment, three period~     crossover design, modified, in situ, study in healthy participants. In this in situ model the~     tubule occlusion properties of dentifrices will be evaluated by comparing an experimental~     dentifrice formulation to a regular fluoride dentifrice and a negative control (mineral~     water) over a ten day period.~   "
61085|NCT02767336|"~     Clinical Evaluation including System Accuracy, User Performance, System Use, Instructions for~     Use and Marketing Claims Evaluation.~   "
61020|NCT02768181|"~     Background:~        1. Burden: The prevalence of stunting among the under-five children in Bangladesh was >55%~          in 1997, which reduced to 41.9% in 2011. This reduction took 14 years to achieve with~          existing interventions, and till today Bangladesh remains among the countries with the~          highest stunting prevalence.~        2. Knowledge gap: In the Lancet series on Maternal and Child Nutrition, Bhutta et al (2013)~          modelled the effect of 10 direct interventions on lives saved and economic costs in 34~          countries which contains 90% of the children with stunted growth. Their findings~          suggested that at 90% coverage, these interventions could cut down under-5 year~          mortality by 15% and avert one-fifth of stunting. The total additional annual cost was~          estimated at $9.6 billion. There is a dearth of primary research, however, to determine~          a feasible, effective bundle of interventions for developing countries.~        3. Relevance: This study will review and test different sets of nutrition-specific~          intervention bundles in a cohort of pregnant women and the subsequent impact on the~          length-for-age Z score (LAZ) of their offspring from that pregnancy.~      Hypothesis: Five selected nutrition-specific interventions implemented during early pregnancy~     and during first two years of child's life in different bundles will cause a shift of 0.4 in~     mean HAZ score among children at 24 months of age compared to those in comparison arm.~      Methods: The investigators propose a community-based randomized trial (CRCT) to evaluate the~     effectiveness of different combinations of the five selected nutrition-specific interventions~     and identify the best combination for improving childhood HAZ. Selected interventions include~     prenatal nutrition supplementation; intensive counselling on prenatal nutrition, exclusive~     breastfeeding and timely complementary feeding; and complementary food supplementation during~     6-23 months. The proposed study area is Habiganj district, Sylhet division. 125 clusters~     (each ~2000 population or ~450 households) will be selected from 12 homogenous unions in 2~     adjacent sub-districts. The clusters will then be randomly assigned to any one of the 5 study~     arms. Data would be collected at baseline and followed up, including on nutritional intake~     and anthropometric measurements of mothers and offspring. Primary outcome measure/variable~     would be mean HAZ of offspring at 24 months. Secondary outcome variables include nutritional~     intake during pregnancy, maternal weight gain, exclusive breast feeding up-to 6 months, and~     birth weight.~      Implications: The investigators expect that the results will serve to inform and shape future~     health policy decisions related to promotion of maternal and child health.~   "
61021|NCT02768168|"~     The purpose of this study is to investigate the efficacy of dezocine pretreatment on~     dexamethasone 21-phosphate induced perineal irritation (include pian and pruritus).~   "
61022|NCT02768155|"~     A study evaluating Amniotic Fluid compared to a Saline Placebo Injection in the treatment of~     subjects with osteoarthritic (OA) knee pain~   "
61023|NCT02768142|"~     Throughout the history, the neonate was dependent on maternal touch and care for survival. In~     modern obstetrics, with hospital care the neonates are seldom separated from their mothers~     after delivery. Early skin to skin (ESTS) contact after delivery was found to increase milk~     production, lactation and improve maternal and neonatal outcome.~      Oxytocin is the primary hormone responsible for uterine contraction and prevention of~     postpartum hemorrhage (PPH). ESTS contact increases oxytocin secretion.~      The rate of cesarean deliveries (CDs) increased dramatically over the past decades. CD was~     found to decrease postpartum milk production, postpones early lactation and decreases~     exclusive breastfeeding.~      During the typical CD, the neonate is usually presented for a short while to the mother and~     breastfeeding is usually delayed at least a number of hours until after the surgery and the~     recovery period.~      Natural CD, enable ESTS contact during the surgery and give the mother the opportunity to~     start breastfeeding immediately after delivery of the neonate in the surgery suit. Oxytocin~     secretion increases with ESTS and during breastfeeding.~      The aim of this study is to examine blood loss that occurs after Natural CD compared to~     standard CD without an ESTS contact.~   "
61024|NCT02768129|"~     The goal of this study is to investigate the role of central neural pathways in mediating~     chronic pain. The aim of the study is to test the effect of stimulating brain regions that~     are part of a network underlying central pain processing using a non-invasive brain~     stimulation technique, transcranial Direct Current Stimulation (tDCS). Prior studies have~     used tDCS to target both sensory related cortical areas and those important for higher-order~     representations of pain. This study will target brain regions important for the behavioral~     response to the chronic sensation of pain. The hypothesis is that stimulation of these brain~     regions can modulate not only the affective component of pain, but ultimately also improve~     functioning and quality of life. This hypothesis will be tested by treating study~     participants eighteen and older with chronic low back pain (CLBP) of greater than six months~     using tDCS. To be part of this study, participants must meet all the inclusion and exclusion~     criteria.~   "
61025|NCT02768116|"~     A Prospective Multi-center Randomized Trial Assessing the Efficacy and Safety of Active~     Transfer of Plaque vs. Provisional T Stenting for the Treatment of Non-Left-Main Coronary~     Bifurcation Lesions.~   "
61026|NCT02768103|"~     The number of people in the United States who have survived SCI is estimated to be~     approximately 273,000 persons. Around 50% of the injuries are to the cervical spine resulting~     in tetraplegia. An important rehabilitation goal in this population is recovery of upper limb~     function, which could decrease medical costs and improve their quality of life.~     Re-establishing active grasp and pinch strength to the hand can be accomplished by surgeries~     that transfer the tendon of a strong muscle to restore strength to a paralyzed muscle, but~     the outcomes of the surgeries are variable. The investigators have demonstrated in an ongoing~     study, the functional gains after surgery can be improved with a focused therapy program to~     retrain the transferred muscle. The propose of this study is to examine the cortical~     mechanisms that drive successful muscle re-education after surgery. Understanding the neural~     (brain) activity associated with functional performance can help to predict who will respond~     to therapy and will guide evidence-based rehabilitation programs to improve upper limb~     function in tetraplegia.~   "
61027|NCT02768090|"~     This study will investigate a new diagnostic technology in order to expand current~     understanding of inflammatory and neoplastic cutaneous disease processes such as eczema,~     psoriasis, granuloma annulare, cutaneous lymphoma, squamous cell carcinoma, basal cell~     carcinoma and melanoma. Protein fragments found in sweat will be collected using a diagnostic~     skin patch and analyzed with mass spectrometry. The goal of this study is to identify~     specific protein fragment biomarkers that may further current understanding of cutaneous~     diseases. The protein expression patterns derived from sweat will be compared to conventional~     histopathologic, immunohistochemical, flow cytometry, in-situ hybridization, polymerase chain~     reaction, and mass spectrometry analyses of cutaneous biopsy specimens. The insight gained~     from this research will be used to promote advances in disease prevention and early~     diagnosis, identify prognostic indicators and new therapeutic targets.~   "
61028|NCT02768077|"~     This clinical study is a double-blind, randomized, placebo-controlled trial to investigate~     the effects of melatonin on the sleep disturbance symptoms of Parkinson's disease patients,~     symptoms which have a significant impact on the quality of life of these patients.~   "
62499|NCT02748824|"~     To assess the five-year incidence of AMD in a population from the central region of Portugal,~     previously phenotypically characterized.~   "
61029|NCT02768064|"~     During Transcatheter aortic valve implantation (TAVI) procedure, a new valve is implanted.~     The valve can be CoreValve (Medtronic Company) or Edward SAPIENS (Edwards Company).~      All TAVI patients require a temporary pacemaker(PMK), which is usually performed by insertion~     of a standard temporary electrode through the femoral vein. The temporary PMK is associated~     with a small but significant rate of complications.~      The PMK is usually removed immediately at the end of the TAVI procedure, only when using the~     Edward SAPIENS valve. The CoreValve valve is more associated with conduction complications,~     and thus the PMK is later removed in these cases.~      PMK Complications seen include:~        -  Right Ventricle perforation by temporary electrode, leading to Pericardial bleeding, in~          some cases with Tamponade~        -  Infection~        -  Electrode dislocation causing In-effective pacing (and/or sensing)~        -  Prolonged bed rest~        -  Prolonged hospitalization~        -  Access related problems (hematoma, pneumothorax) In a review of a large cohort (1) of~          patients from Milan (JACC 2012) the rate of tamponade was 4.3% most of which was~          associated with the temporary PMK.~   "
61030|NCT02768051|"~     Demonstrate the safety, feasibility and usability of the EPD D700 system, for the first time~     in humans, in subjects undergoing ablation for the treatment of atrial flutter.~      Prospective, single-center, non-randomized, open label, single arm study. Ten consented~     subjects who are scheduled to undergo ablation due to atrial flutter. All subjects will~     undergo baseline assessment; intervention (standard fluoroscopy guided RF ablation procedure)~     and post procedure follow up. All subjects will have a follow up visit within 24 hours post~     procedure.~   "
61031|NCT02768038|"~     The aim is to examine the role of intestinal microbiota in the pathogenesis of chronic~     inflammatory bowel diseases (IBD)~   "
61032|NCT02768025|"~     Background: As smoking regulatory policies, including the WHO FCTC (Framework Convention on~     Tobacco Control), are enforcing, demand for smoking cessation treatment is being increased.~      According the trend, development and evaluation of the medical guideline, Induced~     participation of medical personnel and available in Korean medical clinic, is needed.~     Purpose: To evaluate the satisfaction and effect of traditional & complementary medicine~     (T&CM) tobacco control program Methods: Recruited subjects were divided into control and test~     groups. They treated two times a week during the first three weeks and once a week during the~     last week.~      Program participation rates and drop rates, satisfaction, amount of smoking before and after~     programs~      , smoking-related key variables, nicotine dependence test (Fagerstrom test), Expired CO~     amounts, urinary cotinine amount, withdrawal symptoms, the change in quality of life(EQ-5D)~     are measured.~   "
61033|NCT02768012|"~     Antidepressant-induced sexual dysfunction (AISD) affects the majority of women taking~     antidepressants and reduces medication compliance: however there is a paucity of~     evidence-based strategies for the management of this condition. Mindfulness-based cognitive~     therapy (MBCT) has been shown to be effective in the treatment of non-antidepressant-induced~     sexual dysfunction and may be beneficial in the treatment of AISD. The investigators propose~     a randomized, controlled, proof-of-principle trial to establish preliminary evidence of~     efficacy of MBCT in AISD and to inform the design of a larger trial to evaluate its~     effectiveness~   "
61034|NCT02767999|"~     Fluoxetine action on cerebral connectivity changes in acute ischemic stroke patients~   "
61035|NCT02767986|"~     Background:~      Culture can affect the way a person thinks about illness. This can affect how they seek help~     for illness. It can also affect how they choose a treatment and follow it. This can lead to~     health disparities among certain groups of people. Breast and colon cancers are the most~     common cancers for Latinos. Even though they get these cancers at lower rates than other~     population groups, Latinos are more likely to be diagnosed with these cancers at advanced~     stages. Researchers want to study what Latina women immigrants believe causes breast and~     colon cancer and other factors they think play a role in disease. This understanding could~     lead to better interactions between Latinos and their doctors.~      Objective:~      To learn more about what Latina immigrants believe causes breast and colon cancer and other~     factors they think play a role in disease.~      Eligibility:~      Women ages 18 and older who:~      Were born in Latin America~      Speak Spanish~      Have never had breast, ovarian, or colon cancer~      Design:~      Participants will be interviewed in person or over the phone. This will take up to an hour.~     The interview will be recorded. Participants will answer questions about:~      Their family s cancer history~      What they think causes breast and colon cancer~      What they think plays a role in disease~   "
61036|NCT02767973|"~     Purpose: This screening protocol is designed to assess PMN (neutrophil) responsiveness to~     wood smoke particles (WSP) and the effect of the GSTM1 null genotype on this response. The~     researches will identify persons responsive and resistant to the inflammatory effect of WSP.~     It is anticipated that the GSTM1 genotype will be a risk factor for increased response to~     WSP.~   "
61037|NCT02767960|"~     This study valuates the serum Tenascin-C concentration in patients with acute coronary~     syndrome.~   "
61038|NCT02767947|"~     A Randomized, Multi-Center, Double-Blind, Vehicle-Controlled Study~   "
61039|NCT02767934|"~     This phase II clinical trial studies how well pembrolizumab works in treating small amounts~     of cancer cells that remain after attempts to remove the cancer has been made in patients~     with acute lymphoblastic leukemia. Monoclonal antibodies, such as pembrolizumab, may~     strengthen the immune system and help it to target remaining cancer cells.~   "
61040|NCT02767921|"~     This pilot clinical trial studies the side effects of recombinant EphB4-HSA fusion protein~     before surgery in treating patients with transitional cell carcinoma of the bladder, prostate~     cancer, or kidney cancer. Recombinant EphB4-HSA fusion protein may block an enzyme needed for~     tumor cells to multiply and may also prevent the growth of new blood vessels that bring~     nutrients to the tumor. Giving recombinant EphB4-HSA fusion protein before surgery may make~     the tumor smaller and reduce the amount of normal tissue that needs to be removed.~   "
61041|NCT02767908|"~     The present study is proposed to build on the investigators demonstration of the~     effectiveness of default delivery of smoking interventions in hospital inpatients by testing~     a multi-component intervention to prevent relapse to smoking after hospital discharge. The~     proposed intervention is designed to integrate easily with existing services, and hence be~     widely implemented if shown to be effective~   "
61042|NCT02767895|"~     Patients undergoing elective revascularization of their peripheral artery disease will be~     randomized to a prehabilitation program or usual care prior to their scheduled procedure.~   "
61043|NCT02767882|"~     The primary aims of total knee replacement are improvement in functional activities and~     reduce pain due to degenerated knee joints. However, there are around 20-30% of patients~     would develop significant pain problem despite uncomplicated total knee replacement. It~     accounts for major post-operative problems and burdens.~      Dexamethasone is glucocorticoid which is associated with anti-inflammatory response. It is~     well known to have prophylaxis effect for post-operative nausea and vomiting. Perioperative~     single dose of systemic dexamethasone have shown to be useful for reduction in pain and~     cumulative opioid consumption. Meta-analysis from De Oliveira et al supports that~     dexamethasone (up to 0.2 mg/kg) is a safe and effective multimodal pain strategy after~     surgical procedures. However, this dose recommendation is not surgery specific. It is~     essential to have more RCTs evaluating the optimal dose of steroid for pain management after~     hip and knee surgery.~   "
61044|NCT02767869|"~     The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult~     population suffers the disease.~      Banaba has shown evidence that has on metabolic syndrome, insulin sensitivity and insulin~     secretion.~      The investigators hypothesis was that the the administration of resveratrol modifies the~     metabolic syndrome, insulin sensitivity and insulin secretion.~   "
61045|NCT02767856|"~     This study is designed to answer the question: What if the Intermittent Occlusion~     (IO-therapy) glasses were prescribed all day (12-hours) in which the total time of treatment~     only took 4 weeks instead of the current treatment time (4 hours) in which it takes 12 weeks?~      Children aged 3- to 8-years with untreated moderate unilateral amblyopia will be enrolled and~     randomized into 2 groups: 1) Intense 12-hour IO-therapy Group for 4 weeks treatment; or 2)~     Standard 4-hour IO-therapy glasses Group for 12 weeks treatment.~   "
61046|NCT02767843|"~     This pilot study will examine the efficacy and safety of continuous negative external~     pressure (cNEP) for the treatment of chronic snoring in people without obstructive sleep~     apnea.~   "
61047|NCT02767830|"~     A 12 month long program focused on making good food choices and exercise directed at 8-12~     year olds and their caregivers. The program will consist of monthly educational meetings each~     teaching a new nutritional and exercise concept. Children will be given weekly exercise~     schedules and their adherence to the program will be assessed. The study will culminate with~     an annual children's race in May.~   "
61048|NCT02767817|"~     The purpose of this study is to assess the safety and efficacy of injectable collagen~     scaffold combined with Mesenchymal stem cells (MSCs) transplantation in patients with brain~     injury.~   "
61049|NCT02767804|"~     The primary purpose of this study is to evaluate the efficacy and safety of X-396~     (ensartinib) vs. crizotinib in patients with ALK-positive non-small cell lung cancer that~     have received up to 1 prior chemotherapy regimen and no prior ALK inhibitor.~   "
61050|NCT02767791|"~     The management of chemotherapy-induced nausea and vomiting (CINV) has evolved in recent years~     and became less frequent. CINV include early (occurring within 24 hours of chemotherapy~     administration) and delayed (occurring within 4 days after chemotherapy) nausea and vomiting.~      Preventive treatment, such as Glucocorticoids, 5-HT3 receptor antagonists and NK1 receptor~     antagonists, are administered according to the classification in 4 grades of expected CINV~        -  Very low: <10% occurrence of CINV;~        -  Low: 10 to 30% occurrence of CINV;~        -  Average: 30 to 90% occurrence of CINV;~        -  High: > 90% occurrence of CINV. These treatments have been the subject of~          recommendations. Despite these available treatments, some patients still complain of~          vomiting, or more frequently nausea and loss of appetite.~      Meanwhile, Chinese acupuncture has proven effective on the prevention of CINV as~     complementary treatment, mainly in the acute phase and to a lesser extent in the delayed~     phase. The most common points are Pericardium 6 (wrist) treated with conventional acupuncture~     needles, electro-acupuncture or acupressure.~      Auriculotherapy (ear acupuncture) has proven effective on nausea of pregnancy and~     postoperative nausea, but, to our knowledge, there are no studies published on the effect of~     auriculotherapy on CINV.~      These complementary treatments have virtually no side effects. In our institution, a simple~     treatment of acupuncture (2 points Pericardium 6 treated) and auriculotherapy (2 auricular~     point treated) is regularly use in patients who present CINV despite preventive treatment and~     most of them are relieved.~      The investigators propose a clinical trial in this population to assess symptoms improvement~     in patients presenting CINV after their first administration of chemotherapy despite adapted~     preventive treatment. Experimental treatment with semi-permanent needles takes place during~     administration of the second session of chemotherapy. CINV are evaluated through the MAT~     score (Multinational Association of Supportive Care in Cancer Antiemesis Tool.~     Http://www.mascc.org/) that measures the frequency and intensity of nausea and vomiting in~     the 24 hours following the session and during the 4 days after administration Chemotherapy.~   "
61051|NCT02767778|"~     The main purpose of this multicentric, prospective, randomized, placebo-controlled,~     double-blind study is the validation of pulsed ELF-MF stimulation as non-invasive and safe~     tool to promote recovery in acute ischemic stroke patients.~      124 patients with acute ischemic stroke will be recruited and randomly assigned to real or~     sham group. Patients will be stimulated with pulsed ELF-MF (75 Hz, 1,8 mT), for 120 min~     daily, for 5 consecutive days, starting within 48 hours from the onset of stroke.~      The primary outcome will consist of reduction of the expected infarct growth at MR measured~     in the subacute and chronic phase. Secondary outcomes will explore clinical effectiveness,~     safety and tolerability of pulsed ELF-MF in acute ischemic stroke.~   "
61052|NCT02767765|"~     This study will evaluate the efficacy and tolerability of subcutaneous (SC) or intramuscular~     (IM) recombinant human erythropoietin beta (r-HuEPO) in participants with anemia and~     histologically or cytologically confirmed cancer.~   "
61053|NCT02767752|"~     This is a single center, randomized, double-blind, placebo-controlled phase II trial that~     will compare the efficacy of T-ChOS in combination with gemcitabine to gemcitabine alone as~     adjuvant treatment for 6 months in patients with surgically resected pancreatic~     adenocarcinoma.~   "
61054|NCT02767739|"~     Community intervention trial, randomized, to promote regular PA and social and cultural~     support activities for 9 months in older-adult primary care users and assess their effects on~     cardiovascular risk factors and health-related quality of life.~   "
61055|NCT02767726|"~     Cervix cancer is a major global health concern. A way to screen and immediately treat~     precancerous lesions (Screen-and-Treat) is greatly needed. Developed by MobileOCT, polarized~     difference imaging and conventional imaging are used to identify suspicious lesions. We aim~     to compare this non-invasive method with colposcopy. Patients at the Dickens Clinic will have~     3-5 minutes of non-invasive imaging before colposcopy. Pathology will be compared both to~     colposcopy impression versus MobileOCT.~   "
61102|NCT02767115|"~     The aim of this study was to formulate a mucoadhesive gel of grapes seed extract (GSE)~     followed by short-term clinical study for the effectiveness of this gel onto the pocket depth~     (PD), plaque index (PI), gingival index (GI), and bleeding on probing (BOP) when applied in~     periodontal pockets as an adjunct treatment for chronic periodontitis.~   "
62526|NCT02748473|"~     Adding voluntary pelvic floor muscle contraction to a Pilates exercises program can improve~     the pelvic floor muscle strength on sedentary nulliparous women.~   "
61056|NCT02767713|"~     Postoperative cognitive dysfunction (POCD) is the most common complication after cardiac~     surgery. This prospective study was conducted to investigate the mechanisms of development of~     POCD following cardiac surgery taking into account surgical technique (with use or no use of~     extracorporeal circulation). The investigators focused on the role of inflammatory and stress~     response to surgical procedure as potential factors involved in the pathogenesis of cognitive~     dysfunction. Systematic inflammatory response in patients undergoing on-pump or off-pump~     surgery was analyzed by measuring serum levels of C reactive protein (CRP) and occurrence of~     systemic inflammatory response syndrome (SIRS). Stress response to surgery was evaluated~     following cortisol levels and its daily variations. The degree of cognitive dysfunction was~     assessed based on serum levels of S100β. The effect of dexamethasone on the levels of stress~     and inflammatory response biomarkers, serum levels of S100β, as well as on the development of~     POCD was compared with control group that received normal saline.~   "
61057|NCT02767700|"~     The tumor tissue of patients with pancreatic cancer will be submitted to next-generation~     sequencing (NGS) and these data will be evaluated with an oncology treatment decision support~     (TDS) software tool that is a medicinal product class 1 (CE-marked). This software will make~     evidence-based suggestions for drugs likely to be effective, ineffective, or toxic (FDA~     approved biomarkers). For patients fit for second-line therapy, the resulting recommendations~     will be judged by the tumor board.~   "
61058|NCT02767687|"~     This study evaluates whether noninvasive ventilation with continuous positive airway pressure~     affects tissue perfusion in patients after cardiac surgery.~   "
61059|NCT02767674|"~     The purpose of this study is to investigate efficacy and safety of R-GemOx Versus R-miniCHOP~     as first-line treatment of elderly patients with Diffuse large B cell lymphoma~   "
61060|NCT02767661|"~     The study is designed to compare the clinical benefit following treatment with aromatase~     inhibitor in combination with metronomic capecitabine versus aromatase inhibitor alone in~     women with hormone receptor-positive, Her2-negative advanced breast cancer who have not~     received prior systemic anti-cancer therapies for their advanced/metastatic disease.~   "
61061|NCT02767648|"~     The goal of the study is to characterize the epidemiologic data of the neonatal and infant~     cholestasis.~   "
61062|NCT02767635|"~     The aim of the study is to compare two different injection sites of low dose botulinum toxin~     type A with steroid in treating lateral epicondylalgia.~   "
61063|NCT02767622|"~     This study included 20 patients listed for liver transplantation in addition to 20 age- and~     sex- matched controls. Neurological, psychiatric, laboratory and radiological examinations~     were performed for both patients and controls before and 6 months after liver~     transplantation. Assessment of cognitive functions by Trail Making Test A (TMT A), TMT B,~     Digit Symbol Test (DST), and Serial Dotting Test (SDT) was done before and after liver~     transplantation.~   "
61064|NCT02767609|"~     This study will test a new MRI sequence that measures cerebral blood flow (CBF). Because this~     technique for measuring CBF is new, there is little information on what the normal values for~     different regions of the brain should be. Information from the study will be used to~     establish normative CBF values for the brain, improving the reliable use of this technique~     for the diagnosis of brain injury or disease.~   "
61065|NCT02767596|"~     The study aims to examine the effectiveness of the short acting GLP-1 analog, Lixisenatide to~     achieve glycemic control in type 2 diabetes patients, in patients with failure of long acting~     GLP-1 analog.~      Patients who fail to achieve significant improvement in diabetes control on basal insulin and~     Liraglutide will be switched to basal insulin and lixisenatide treatment for 12 weeks. The~     primary outcomes will be changes in HBA1C and weight.~   "
61066|NCT02767583|"~     Background / rational:~      Obesity is associated with significant comorbidities including type 2 diabetes (insulin~     resistance), heart disease, stroke, hypertension, sleep apnea syndrome, dyslipidemia, cancer,~     hepatobiliary diseases, orthopedic complications and psychosocial impact 1 .~      Peripheral neuropathy is a known complication in the type I and II diabetes and glucose~     intolerance and metabolic syndrome in 2. Outside of diabetes (type I and II) that are~     associated with cardiovascular risk high vascular, presence of metabolic syndrome constitutes~     in itself a well demonstrated vascular risk factor. Its definition requires the presence of~     three elements from the following 5: abdominal obesity (high waist circumference), high blood~     pressure, high fasting blood sugar, high triglycerides and / low HDL-cholesterol 3.~      This peripheral neuropathy predominantly affects sensory fibers of small poorly myelinated~     diameter (Aδ fibers and C) and autonomous sensory fibers and is called small fiber neuropathy~     4. The cardinal sign of NAION is the presence of neuropathic pain but abnormalities in~     physical examination are often absent and conventional electromyography is faulted to make~     the diagnosis. These small fibers are also constituent of the autonomic nervous system and~     causes damage autonomic dysfunction that can manifest the cardiovascular system (hypotension,~     cardiac conduction disorders), digestive, sweat, sphincter. neuropathy of the diagnosis of~     small fibers is suggested clinically by the presence of neuropathic pain often contrasting~     with a normal clinical examination. The confirmation is based on electrophysiology with~     various techniques and quantification of intra-epidermal nerve fibers.~      Main objective / secondary:~      Primary objective :~      To determine the prevalence of a small fiber peripheral neuropathy in nondiabetic obese~     patients, by measuring skin conductance ion Chlorine (Sudoscan®) evaluating small fibers C~     autonomic~      Secondary objectives:~        -  Evaluation of the prevalence of occurrence of peripheral neuropathy by Sudoscan® during~          follow-up after treatment of obese patients with bariatric surgery (months) M1, 3, 6, 9,~          12.~        -  Correlation of results obtained Sudoscan® quantitative sensory testing (QST) Thermotest®~          evaluating small sensory fibers Aδ, among non-operated non-diabetic obese patients and~          in the postoperative follow-up (months) M1, 3, 6, 9, 12.~        -  Characterization of electromyographic parameters (motor and sensory conduction) in~          patients with a skin conductance measured by lowered Sudoscan® and / or a threshold of~          sensitivity to pain increased Thermotest®.~        -  Correlation between the presence of a small fiber neuropathy in non-diabetic obese~          subjects with clinical and biological parameters collected.~      Methodology Design: prospective, single-center Study duration: 24 months (estimate: 3-5~     patients included / week of 15 patients collected in central obesity / week) including 12~     months of inclusion.~      Number of topics to include: 100 over a period of one year to adjust to the rhythm of the~     inclusions.~      As mentioned, patients will be a measure of impedance of the skin to products chlorine ions~     by the sweat glands via the Sudoscan®, marketed and used among diabetic patients or not for~     the detection of violations neuropathic (cf. references and CE certificate attached to the~     dossier).~      The Thermotest® is also marketed and used in diabetic and non-diabetic patients (see~     references and CE certificate attached to the dossier).~      Our center has gained experience of these techniques for the detection of peripheral~     neuropathy in several patient populations (diabetes and cancer in particular); manipulators~     (doctors and technicians) are trained in these techniques.~   "
61067|NCT02767570|"~     Nearly one out of every two Americans will develop knee osteoarthritis by age 85. Over 20~     million Americans, including nearly three million Veterans, currently have painful knee~     arthritis that limits their daily activity or recreation. The vast majority of those~     individuals will be prescribed anti-inflammatory drugs that provide some pain relief but do~     not slow the progression of the disease. Often people with knee arthritis are told they must~     live with the pain until they become appropriate candidates for knee replacement surgery, but~     that can require tolerating the pain and limiting function for many years. Because of other~     health issues, some individuals are never acceptable surgery candidates. What is desperately~     needed are better conservative approaches for treating these patients. Two such approaches~     will be tested and compared in this study.~   "
61068|NCT02767557|"~     This is a single center, 2-arms prospective randomized phase II trial which evaluates whether~     tocilizumab with gemcitabine/nab-paclitaxel is more effective than~     gemcitabine/nab-paclitaxel.~   "
61069|NCT02767544|"~     In cases of laparoscopic hysterectomy , women were randomized to two groups: ropivacaine (~     vaginal wound infiltration analgesia) vs. control group. Results regarding postoperative pain~     and need of oxycodone.~   "
61070|NCT02767531|"~     Patients with Type I Hyperlipoproteinemia (T1HLP) have a rare form of hypertriglyceridemia~     marked by significant chylomicronemia and recurrent episodes of acute pancreatitis. T1HLP is~     caused by a deficiency of lipoprotein lipase or one of its cofactors. Many patients are a~     challenge to treat, as the only effective therapy available is an extremely low fat diet.~     This diet is exceedingly difficult to follow, and despite adherence, many patients still have~     chylomicronemia and develop acute pancreatitis.~      Specific Aim: To determine the efficacy of a gastric and pancreatic lipase inhibitor,~     Orlistat, in reducing serum triglyceride levels in patients with T1HLP.~   "
61071|NCT02767518|"~     This is a 2-group study comparing the effect of a prehabilitation program to usual care on~     quality of life and clinical outcomes in patients undergoing elective repair of their~     thoracic aorta.~   "
61072|NCT02767505|"~     This is nationwide registry-based randomized clinical multicenter trial in which patients~     will be randomized to gastric bypass (RYGB) or sleeve gastrectomy (SG). The co-primary~     endpoint are weight control over 5 years and the amount of severe adverse events.~     Additionally the investigators have predefined a number of secondary endpoints, and the trial~     has a sufficient number of patients to allow comparisons across subgroups.~   "
61140|NCT02766608|"~     This is a Phase III randomized, double-blind, parallel group, multi-center, 24-week lung~     function study with BFF MDI (320/9.6 μg and 160/9.6 μg) compared to FF MDI 9.6 μg, BD MDI 320~     μg, and open-label Symbicort® TBH (200/6 μg) administered BID.~   "
61073|NCT02767492|"~     This study will include patients who are diagnosed with knee OA and are recommended for a~     knee injection. Study subjects will be randomized to receive either the standard of care knee~     injection (steroid) or amniotic tissue injection (BioDRestore). Study subjects will be asked~     for permission for a baseline knee aspiration prior to the knee injection. At 6 months~     post-injection, knee aspirations will be taken and sent for analysis. Study subjects will be~     followed for 1 year post-injection to include range of motion measurements and~     patient-reported pain/functional outcome measurements. X-rays will also be taken at the~     1-year post-injection appointment.~   "
61074|NCT02767479|"~     Patients infected with H. pylori are treated with rabeprazole 10 mg bid, AMPC 750 mg bid and~     CAM 200 mg bid or esomeprazole 20 mg bid, AMPC 750 mg bid and CAM 200 mg bid. Eradication~     rates are compared. Patients who have ever failed in eradication by CAM-based regimen are~     treated with rabeprazole 10 mg bid, AMPC 750 mg bid and MNZ 250 mg bid or esomeprazole 20 mg~     bid, AMPC 750 mg bid and MNZ 250 mg bid.~   "
61075|NCT02767466|"~     Using a single blind within-subject design, 16 patients with neurological disorders were~     randomly exposed to two different treatments: physical therapy and robotic assisted gait~     training. Both before and after the treatments, a self-report Mood Survey Scale (MSS) was~     used to assess the effects on the treatment on distinct affective states. The subscales of~     the MSS were tested for pre-post changes and different effects between treatments with~     non-parametric tests.~   "
61076|NCT02767453|"~     The purpose of this study is to determine the limited effectiveness of drains during Total~     Shoulder Arthroplasty. Drains are used during joint arthroplasty procedures to decrease~     infection rates, swelling,and the number of dressing changes required during a hospital stay.~     The use of drains has been heavily investigated in the hip and knee replacement literature,~     but there have been no investigations regarding their use in shoulder replacements, despite~     frequent use.~      Clinical benefit has not been consistently documented regarding drain usage in hip and knee~     arthroplasty and the investigators hypothesize that they are of limited utility in total~     shoulder arthroplasty as well. The investigators will perform a prospective investigation of~     total shoulder arthroplasty patients- dividing them into two groups- half will receive a~     drain at the time of surgery and the other half will not be receiving a drain.~   "
61077|NCT02767440|"~     Current models of outpatient childhood obesity treatment focus on the child's health habits,~     with limited efficacy. In part, this may be because childhood obesity is highly sensitive to~     parental lifestyle habits, who are often not a direct target of child obesity interventions.~     This study aims to target weight loss among overweight parents of 2-16 year old children with~     obesity enrolled in the Duke Healthy Lifestyles Program (HL) in order to augment child body~     mass index reduction. The intervention,  Families on Track is a digital health intervention~     platform using the Interactive Obesity Treatment Approach (iOTA).~   "
61078|NCT02767427|"~     The study team hypothesizes that at-home cleansing of the surgical site with chlorhexidine~     wipes provide no added benefit to decreasing microbial activity or preventing surgical site~     infections.~      Patients will be randomized to the chlorhexidine or no additional intervention groups.~     Patients will be randomized to use 4% chlorhexidine cloths, while the other half receive no~     additional intervention. Those randomized into the chlorhexidine gluconate home-application~     group will be asked to shower the night before surgery, and to use a standardized~     pre-packaged chlorhexidine gluconate wipe (that the patients would receive at their~     pre-surgical consultation) on their surgical site after thoroughly drying those areas. The~     patients will be asked to use a second wipe in each area the morning of surgery. The surgical~     sites will be analyzed in two groups: anterior cervical and posterior spine. Each of these~     two groups will be randomized separately. All patients will undergo a standardized~     preoperative cleansing regimen. Once positioned, they will be cleansed with an alcohol~     solution. Then, the surgical site (either the anterior portion of the neck or the posterior~     area of the spine) will be scrubbed with chlorhexidine soaked brushes and then painted with~     chlorhexidine solution. Perioperative antibiotics will be given per attending surgeon~     preference. Cutaneous samples will be taken from the surgical site of each patient at each~     time point.~   "
61079|NCT02767414|"~     The primary purpose of this study is to validate the sensitivity and specificity of the~     Respirio Flu Test and the eLab Flu Test in detecting Influenza A as compared to the gold~     standard for detection, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).~      The secondary aims are to:~      Validate the sensitivity and specificity of the Respirio Flu Test and the eLab Flu Test in~     detecting Influenza B as compared to the gold standard for detection, Reverse Transcriptase~     Polymerase Chain Reaction (RT-PCR); Evaluate the correct interpretation of the Respirio Flu~     Test by subjects with influenza-like symptoms; Evaluate the subjects' satisfaction with the~     convenience, comfort and ease of use of the Respirio Flu Test.~   "
61080|NCT02767401|"~     The purpose of this study is to investigate the effect of percutaneous coronary intervention~     (PCI) on myocardial viability in coronary artery disease patients with single coronary total~     occlusion (CTO) lesions.~   "
61081|NCT02767388|"~     Broadly speaking, the goal of this study is to better understand the influence of~     chemotherapy treatment on the cognitive and neural mechanisms underlying human behavior.~     Extant literature lacks diversity in studied cancer populations and treatment protocols, and~     provides limited understanding of the cognitive abilities that are impaired by chemotherapy.~     To overcome these limitations, this study will employ a sophisticated battery of tests on an~     understudied cancer population. Eligible participants will either be patients diagnosed with~     hematological malignancy (HM) or demographically matched healthy control patients.~      After HM diagnosis and treatment protocols have been established, patients will be inducted~     into the longitudinal study comprised of three visits: 1) after diagnosis but prior to~     chemotherapy treatment (baseline), 2) after one treatment cycle (one month post-baseline),~     and 3) after three treatment cycles (three months post-baseline). Patients will undergo a~     test battery designed to measure specific behavioral and neural mechanisms of attention;~     tests will either be computer-based cognitive tasks or simulated driving tests that immerse~     patients into virtual driving scenarios. During each test, EEG will be concurrently measured~     through non-invasive scalp electrophysiology recordings; EEG recordings will reveal~     underlying neural mechanisms affected by chemotherapy. Additionally, neuropsychological tests~     of vision, attention, and memory will be administered, as well as questionnaires to evaluate~     health, mobility, and life space. Finally, blood samples will be collected to examine levels~     of circulating inflammation-specific proteins typically present in cancer patients. This~     study will allow us to better understand the mechanisms through which chemotherapy influences~     cognitive performance. Results from this study will influence the administration of~     chemotherapy treatments so that patients can continue to receive the highest medical care~     while maintaining optimal cognitive abilities and quality of life.~   "
61082|NCT02767375|"~     To study if the addition of HAIC following complete removal of early stage liver cancer of~     HCC will prevent or delay the recurrence of the disease. Half of the participant will receive~     two cycles of the HAIC after the hepatectomy, while the other half will return to the~     baseline surveillance schedule.~   "
61086|NCT02767323|"~     Cognitive decline and dementia have become important public health issues in our time as~     medical science has increased lifespan and our society becomes progressively older. A great~     deal of the cognitive decline due to aging can be explained by decline in working memory~     (WM), a mental function central to cognition in which aging deficits appear almost~     universally. Attempts to use WM training to increase WM ability in older adults has had some~     success, but the transfer of performance enhancements caused by this training to other~     cognitive skills is controversial. Another intervention that shows much promise is~     noninvasive stimulation of cerebral cortex using transcranial magnetic stimulation (TMS),~     which has been shown to increase performance in many cognitive tasks. Here, the investigator~     proposes to use fMRI-guided TMS enhancement paradigm to stimulate dorsolateral prefrontal~     cortex (DLPFC), a region involved not only in the maintenance of items in WM, but also in~     their manipulation, in order to create WM performance enhancements that will be long lasting~     and that will transfer to other cognitive tasks as well. This will be achieved through three~     studies. In the first the investigator will stimulate both old and young healthy adults while~     they perform different WM tasks that will increasingly engage DLPFC in order to demonstrate~     enhancement of WM performance that is greater in the older adults. In the second and third~     studies, older adults will receive active or sham TMS over two weeks of daily sessions while~     they perform the WM tasks. In the second study, the investigator hopes to demonstrate that~     the cumulative effect of multiple TMS sessions, in tandem with the synergistic effects of~     simultaneous TMS + WM training, create WM performance enhancements greater than those found~     with WM training alone, whose effects are long-lasting, continuing a month following the~     course of TMS sessions. In the third, the investigator will investigate whether the WM~     enhancements generated by the two weeks of TMS sessions will generalize to other cognitive~     tasks. Success of these studies will provide proof in principle for long-lasting,~     transferable effects of TMS in remediating WM and more general cognitive deficits due to~     aging, and point to a possible non-invasive brain stimulation therapy for cognitive decline~     in healthy aging and in dementia.~   "
61087|NCT02767310|"~     The purpose of this study is to determine the bioequivalence of Rosuvastatin/ Verisfield 20~     mg film-coated tablets and Crestor™/ AstraZeneca 20 mg film-coated tablets.~   "
61088|NCT02767297|"~     To determine the relative bioavailability of the capsule (reference) and tablet (test)~     formulations of FDL169 in healthy adult males and females, and to evaluate the~     pharmacokinetic (PK) profile FDL169 tablets (test formulation) in both healthy adult males~     and females, and subjects with cystic fibrosis (CF).~   "
61089|NCT02767284|"~     This study evaluates the relative performance of different methods to measure the human~     spectral contrast sensitivity function (CSF).~   "
61090|NCT02767271|"~     The objective of this study is to evaluate the pharmacokinetics of Luliconazole Cream 1% in~     subjects with moderate to severe tinea pedis or tinea cruris.~   "
61091|NCT02767258|"~     Clinical trial for prevention, randomized controlled, parallel, double-blind, with three~     arms, which purpose is verify the nursing interventions (artificial tear gel and liquid~     artificial tears)effects to prevent dry eye in adult patients admitted in ICU.~   "
61092|NCT02767245|"~     Thyrotoxicosis is a hypermetabolic state in which there is increased utilization of thiamine.~     Thiamine deficiency has been observed in association with hyperthyroidism. Several studies~     documented that thiamine treatment could improve signs and symptoms of congestive heart~     failure, or even improve left ventricular ejection fraction in patients without~     thyrotoxicosis. This pilot study aims to evaluate prevalence of thiamine deficiency and~     assess improvement of cardiovascular function after receiving thiamine supplement in~     thyrotoxic patients.~   "
61093|NCT02767232|"~     The purpose of this study is to determine if the use of adjunctive catheter-directed~     thrombolysis (CDT), which includes the intrathrombus administration of rt-PA~     (Activase/Alteplase), can prevent post-thrombotic syndrome (PTS) in pediatric patients with~     symptomatic proximal deep vein thrombosis (DVT) as compared with optimal standard~     anticoagulation alone.~   "
61094|NCT02767219|"~     This is a phase III randomised controlled pilot study which aims to assess the effectiveness~     of the use of bevacizumab in patients who have undergone trabeculectomy surgery, which appear~     to be showing early signs of failure.~   "
61095|NCT02767206|"~     The study aims to evaluate the feasibility of transnasal endoscopy in patients with portal~     hypertension, cirrhotic and non-cirrhotic. The incidence of the procedure's adverse effects,~     the patient's tolerance and his/her opinion about the exam are analyzed. In addition, the~     interobserver matched for the discoveries found in the study is carried out.~   "
61096|NCT02767193|"~     single-center, national clinical trial, phase I, randomized (1: 1: 1: 1), prospective,~     placebo-controlled, partially masked, parallel group. Patients will be assigned to one of the~     following four arms: 3 immunizations of dendritic cells / 3 immunizations of dendritic cells~     with pegylated interferon + / 3 immunizations of placebo / 3 immunizations of placebo with~     pegylated interferon.~   "
61097|NCT02767180|"~     An ICU-specific questionnaire for patient reported outcome measures (PROM) after critical~     care will be tested in a study of 650 patients recruited six months to three years after~     discharge from the ICU, and 150 controls who have not been critically ill, matched for age~     and sex. The questionnaire is sent by mail after an invitation letter followed by a phone~     call and returned in a pre-stamped envelope. It is then scanned and data imported digitally.~     Medical data from the ICU-stay can be added. Further analyses after comparison with the~     control population and item reduction will follow.~   "
61098|NCT02767167|"~     Iodine is an essential trace element necessary for the synthesis of thyroid hormones which~     are critical for human growth and development throughout the lifecycle. Iodine is~     particularly important during pregnancy and infancy for brain and neurological development.~     Severe iodine deficiency during pregnancy can cause severe mental impairment and stillbirth~     while mild-to-moderate deficiency has been associated with impaired infant development. As~     such, pregnant women and women of child-bearing age are particularly vulnerable to the~     effects of iodine deficiency.~      Globally, 241 million (30%) school aged children are iodine deficient. Historically, the UK~     and Ireland were believed to be iodine sufficient but concern has been expressed in the last~     decade regarding the iodine status of the UK and Irish populations. A study of Irish women in~     2004 reported 55% of pregnant women in their sample population to be moderately iodine~     deficient and 53% of non-pregnant women to be moderately iodine deficient. A study of UK~     schoolgirls found that 51% were mildly iodine deficient and 16% were moderately deficient.~     Importantly, the prevalence of iodine deficiency was highest in Northern Ireland where 85% of~     those sampled were iodine deficient.~      Iodine is known to interact with selenium in the conversion of the thyroid hormone thyroxine~     (T4) to the metabolically active triiodothyonine (T3) hormone. Selenium is also important for~     immune, cardiovascular and cognitive function. Selenium status has been reported to be~     moderately low using pooled English data on blood selenium concentrations from 1984 to 1992.~     In addition, the latest National Diet and Nutrition Survey reports that selenium intakes are~     below recommendations for several population groups including women of childbearing age where~     mean selenium intakes are 76% of the recommended 60µg/day. This national survey also reported~     that 49% of women aged 19-64 years failed to meet the lower reference nutrient intake of~     40µg/day.~      Milk and dairy products are the major source of iodine for the UK population and are also a~     source of selenium. The contribution of milk and dairy products to iodine and selenium~     intakes is greatest in adult females (35% and 6% respectively). Observational evidence has~     repeatedly reported milk consumption to be positively correlated with iodine status and~     iodine intakes. Research in Iceland and New Zealand has reported that milk consumption is not~     associated with selenium status; however it is unknown if this is true for the UK population.~      To date, no randomised controlled trial has examined the effect of milk consumption on either~     iodine or selenium status. The possibility of increasing iodine and selenium intake by~     increasing milk consumption, a widely available and consumed foodstuff, in a population group~     vulnerable to micronutrient deficiency should be investigated. This would add valuable data~     to the knowledge base for iodine, where there is ongoing debate over the most appropriate~     means of increasing iodine intake amongst women of childbearing age in the UK where salt~     iodisation, the key strategy in preventing deficiency, is not implemented.~      The aim of this study is to investigate the impact of cow's milk consumption on the~     biological status of iodine and selenium among women of child-bearing age.~      The study will be a 12 week randomised-controlled human intervention study. Participants will~     be randomised to consume additional semi-skimmed milk in the Following amounts, control group~     (0mls/day), intervention group (430mls/day or 3l per week).~   "
61099|NCT02767154|"~     This study will compare two priming solutions for extracorporeal circulation, one based on~     Dextran 40, one based on crystalloid and mannitol. Primary endpoint is oncotic pressure~     during cardiopulmonary bypass. Secondary endpoints included fluid balance and organ~     functions.~   "
61100|NCT02767141|"~     Children without consistent access to sufficient and nutritious food show sustained~     disadvantages. To improve food security, households utilize three types of coping strategies-~     participating in governmental feeding and financial assistance programs; obtaining food from~     nongovernment providers; and using individually developed strategies. To understand the~     interdependencies among strategies and decision-making processes used to select them, the~     investigators conducted a two-phased, mixed-methods study using a socio-ecological~     theoretical framework. First, employing a cross sectional, observational design the~     investigators administered in-person surveys to 320 adults in very low food secure (VLFS)~     households with children. Over 1 year later, the investigators repeated select questions and~     conducted in depth interviews with a cohort (n=28) of participants. Descriptive statistics~     defined magnitude of associations among strategies. Following bivariate analysis, the~     investigators assessed interdependencies and factors affecting relationships with log-linear~     models. The investigators analyzed interviews using an hierarchically ordered, analytical~     coding structure. With Qualitative Comparative Analysis (QCA), the investigators developed~     typologies of VLFS and created models treating food security as an outcome. The association~     of soup kitchen use and nutritionally risky behavior was altered by Supplemental Security~     Income (SSI) or Social Security Disability Insurance (SSDI). Food safety-related risky~     behavior level related to intensity of food pantry use by participation in school food~     programs. Supplemental Nutrition Assistance Program (SNAP) did not affect the association~     between soup kitchen use and risky food safety behaviors. Key interview constructs included~     becoming and being short of food; coping strategies; decisions used to inform choice of~     strategies; and managing a devalued social status. Improved income stability was a necessary~     condition for improving food security.~   "
61101|NCT02767128|"~     The main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered~     orally in healthy adult volunteers. It is a randomized multiple treatments, single dose~     study.~   "
61103|NCT02767102|"~     Melatonin (MLT) is a bioactive compound in red wine. The investigators will investigate the~     serum and salivary concentrations and antioxidant power of MLT after the intake of a glass of~     red wine. Twelve healthy volunteers were recruited to receive both 125 mL of red wine rich in~     MLT (10 ng mL-1) and without MLT (placebo), via a randomized, cross-over, and double-blind~     design. Serum and salivary MLT will be measured by liquid chromatography coupled to mass~     spectrometry (LC-MS) and enzyme-linked immunosorbent (ELISA), respectively. The ferric ion~     reducing antioxidant power (FRAP) will be analyzed.~   "
61104|NCT02767089|"~     The purpose of this study is to further access the utility of biochemical and clinical~     biomarkers for glucocorticoid-mediated anti-inflammatory effects and safety endpoints against~     which dissociated agonists of the glucocorticoid receptor (DAGR) will be evaluated in adult~     healthy volunteers.~   "
61105|NCT02767076|"~     To identify the value of using the ultrasound in applying a commonly used regional~     anaesthetic procedure (spinal anaesthesia) when compared with the conventional landmark~     guided approach, regarding the efficiency of the anaesthetic technique, incidence of~     associated common complications and patient's satisfaction.~   "
61106|NCT02767063|"~     Patients will be randomized in phase II trials to continue on the same TKI versus one of the~     alternative treatment approaches. If a patient is not eligible for one of the treatments, he~     (she) will be randomized between the options for which he (she) is eligible.~      The trial will start with current available treatment options (experimental arms). New~     available treatment options may be open at any times later on. Authorized TKIs are imatinib,~     nilotinib, dasatinib, bosutinib and ponatinib.~      For all options the treatment duration is for a minimum of 12 months and will be continued in~     the absence of adverse events following investigator decision. Each therapeutic option will~     be detailed in term of combination modalities, dose, dose adaptation, specific warnings,~     specific exclusion and inclusion criteria. The decision to introduce a new option will depend~     on the general pace of recruitment and on the assessment of the potential efficacy and safety~     of the new treatment, and will be implemented after scientific review by a protocol~     amendment.~      Primary objective:~      A. To select molecules in combination or sequentially with imatinib, nilotinib, dasatinib,~     bosutinib or ponatinib potentially able to produce a 25% increase in the Cumulative Incidence~     of MR4.5 as compare to control.~      Secondary objectives:~      A. To determine the safety of selected therapies~      B. To determine the rate of MR4 by 12, 24, 36, 48 months in experimental and control arms~      C. To determine the rates of MR4.5 by 24, 36, 48 months in experimental and control arms~      D. To determine the rate of undetectable BCR-ABL1 transcript (sensitivity 40000 ABL copies)~     by 12, 24, 36, 48 months in experimental and control arms~      E. To estimate treatment free remission (TFR) in patients eligible for discontinuation~     studies~      F. To investigate the relationship between biological activity and the clinical efficacy of~     the selected therapies~      G. To assess the effects of the treatments on the number and clonogenicity of CML stem cells~     and other biological markers of interest~      H. To estimate duration of response, progression-free survival, event free survival and~     overall survival.~   "
61107|NCT02767050|"~     The following observational study evaluates incidence of caries in smoking and smokeless~     tobacco based on habit history by clinical examination and DMFT index.~   "
61108|NCT02767037|"~     Currently, there is no clear diagnostic test that can be used to confirm the diagnosis of~     Parkinson's disease, or a biomarker that can track its progression. Patients with Parkinson's~     have many abnormalities of the autonomic nervous system, which may be related to Parkinson's~     changes outside of the brain. A new device called the SudoScan, which measures autonomic~     sweating changes, may be a simple way to test for autonomic changes in Parkinson's.~      The investigator plan to see whether SudoScan can identify Parkinson's disease and whether~     SudoScan abnormalities might be present even in early (prodromal) Parkinson's stages.~      The investigator will assess SudoScan in a group of Parkinson's patients, normal healthy~     controls, patients with non-Parkinson's neurodegeneration, and patients with REM sleep~     behavior disorder (an early/prodromal Parkinson's state). Abnormalities will be correlated~     with standard autonomic tests and with skin biopsy findings Parkinson's degeneration in the~     peripheral autonomic fibers.~      If the investigator can find a reliable way to diagnose and follow Parkinson's disease, he~     will be able to correctly identify Parkinson's (even in its earliest stages). This will~     improve the chance to find protective treatments against Parkinson's, by preventing false~     diagnosis and by providing a new marker to track disease progression.~      If successful, the investigator will aim to validate the findings on a large sample of~     Parkinson's and also to track changes over time in the original cohorts~   "
61109|NCT02767024|"~     Single center, prospective, randomized, non-blinded research study comparing intravenous~     vasodilator infusion vs. inotropic infusion in patients admitted to the hospital or in the~     emergency room at Montefiore Medical Center presenting with the diagnosis of acute~     decompensated systolic heart failure with low cardiac output but no hypotensive.~   "
61110|NCT02767011|"~     Abstract:~      It is intuitive that post discharge surgical complications are associated with increased~     patient dissatisfaction, and directly associated with an increase in medical expenditures. It~     is also easy to make the connection that many post hospital discharge surgical complications~     including surgical site infections could be influenced or exacerbated by patient~     co-morbidities. The authors of a recent study reported that female gender, obesity, diabetes,~     smoking, hypertension, coronary artery disease, critical limb ischemia, chronic obstructive~     pulmonary disease, dyspnea, and neurologic disease were all of among significant predictors~     of surgical site infections after vascular reconstruction was performed. The main concern for~     optimal patient care especially in geographically isolated areas of West Virginia is to have~     early, expeditious, and prompt diagnosis of early surgical site infection with subsequent~     indicated interventions. This theme will lead to patient satisfaction, minimizing third party~     interventions and decrease the total cost associated with these complications. Nevertheless,~     it seems reasonable to believe that monitoring using telehealth technology and managing the~     general health care patients receive after a hospital vascular intervention will improve~     overall health and reduce post-operative complications.~      Aims/Objectives:~      1. The primary objective of the current project is to compare early and late outcomes for~     patients who receive post discharge health care monitoring (which includes using Telehealth~     electronic monitoring; THEM) to patients who receive standard of care (SOC) and routine~     discharge instructions and no monitoring.~      Methods:~        1. Randomize patients who are scheduled to have revascularization interventions with groin~          incisions to receive either telehealth electronic health care monitoring or normal~          standard of follow-up care.~        2. Follow patients for 4 weeks, record any 30-day hospital readmissions or complications.~          In addition, have participants complete the follow-up survey questionnaires.~   "
61111|NCT02766998|"~     This is a prospective, single center, safety and feasibility trial to evaluate the use of~     autologous umbilical vein as shunts or conduits in neonatal cardiac surgery. Subjects will be~     identified here at the Advanced Fetal Care Center (AFCC) following diagnosis of congenital~     heart disease (CHD) with single ventricle physiology of the fetus via fetal echocardiogram.~     At time of cesarean section or vaginal delivery, umbilical cord will be harvested in a~     sterile fashion and the umbilical vein will be dissected free and preserved until first~     clinically indicated Stage I palliative procedure between day 3 and 7 of life. Subjects will~     be followed until their Stage II palliative procedure.~   "
61112|NCT02766985|"~     The purpose of this study is to make a standardized and scalable Rasch-built clinical~     severity scale to help in finding genetic and environmental modifiers of disease in~     Facioscapulohumeral muscular dystrophy (FSHD).~   "
61374|NCT02763540|"~     Pathological comparisons of surgical open lung biopsies and cryobiopsies in non-IPF ILD.~     Patients with non-IPF ILD eligible for an open lung biopsy will undergo cryobiopsy in the~     same time. Between observers agreement will be assessed for each pairs of samples.~   "
61113|NCT02766972|"~     Treatment of complex unruptured intracranial aneurysms (UIA) remains challenging to date.~     Therefore, advanced techniques are required to achieve an optimal result in treating these~     patients safely. In this study, the safety and efficacy of rapid ventricular pacing (RVP) to~     facilitate microsurgical clip-reconstruction has been studied prospectively in a joined~     neurosurgical, anesthesiological and cardiological study.~   "
61114|NCT02766959|"~     This single-site, within-subject experimental basic research study is designed to analyze the~     hypothesis that allele-specific expression of the bitter taste receptor T2R38 in taste tissue~     of individuals heterozygous for the taste receptor gene TAS2R38 correlates with that in nasal~     epithelium, and is responsible for differences in acyl-homoserine lactone-induced respiratory~     defenses. Subjects will include 100 predominantly European adults without chronic~     rhinosinusitis who will be undergoing a sinonasal procedure for reconstructive purposes. All~     subjects will provide saliva samples for genotyping, from which 25 subjects heterozygous for~     TAS2R38 (AVI/PAV) will be identified. These individuals will be asked to complete a beverage~     frequency questionnaire and taste test prior to the procedure that will evaluate for a number~     of compounds, among them bitter ligands specific to T2R38. Their tongue will also be~     photographed to evaluate the anatomy of their fungiform papillae, the mushroom-like~     structures on the tongue which contain taste buds. Subjects will subsequently provide nasal~     epithelium and taste tissue, which will be processed to 1) evaluate for allele-specific~     expression of TAS2R38 mRNA in both the taste and nasal tissue, with the nasal tissue~     concurrently being cultured in an air-liquid interface system to 2) assess the AHL-induced~     respiratory defenses of ciliary beat frequency (CBF) and nitric oxide (NO) production. Should~     subjects require a subsequent sinonasal procedure for clinically-determined reasons, taste~     and nasal tissue will again be obtained and analyzed for TAS2R38 mRNA, allowing for 3)~     longitudinal evaluation of mRNA expression level.~   "
61115|NCT02766946|"~     Ventilatory support during critical phase result in inactivity of respiratory muscles~     especially diaphragm muscle. These inactivity also result in change of contractile capability~     and quick muscular atrophy.~      The aim of the study is to visualize the evolution of diaphragm thickness by echography~     during Mechanical Ventilation for patients with septic shock or acute respiratory distress~     syndrome and to compare with the evolution for patients under non-invasive ventilation and~     those with spontaneous ventilation. Measurements will be performed at day 1, day 5 and day 10~     (if patient still under a mode of ventilation or in the unit).~      The evolution of diaphragm thickness will also be compared to pectoralis muscle atrophy,~     which is not involved in ventilation, in order to assess respective effect of ventilatory~     inactivity and undernutrition linked to intensive care.~   "
61116|NCT02766933|"~     The natural history and response to therapy of chronic hepatitis B infection in West Africa~     are currently poorly understood. In this study, employees of the Cameroon Baptist Convention~     Health Board (CBCHB) and spouses who are found to be hepatitis B positive on screening will~     be offered enrollment. Disease monitoring and treatment will be provided following current~     WHO guidelines. Clinical data will be prospectively recorded for 5 years, and bio-specimens~     will be frozen for future analysis.~   "
61117|NCT02766907|"~     Prospective study to evaluate the efficacy of using self-retained cryopreserved amniotic~     membrane after debridement in treating Epithelial Base Membrane Dystrophy (EBMD) to optimize~     the ocular surface integrity and intraocular lens calculation before cataract surgery.~   "
61118|NCT02766894|"~     Comparison of conventional assessment of anesthetic depth by anesthesiologists (moderate,~     deep or light anesthesia) with EEG monitoring (Narcotrend® state/index). In case of mismatch~     statistical analysis for underlying factors are done.~   "
61119|NCT02766881|"~     To evaluate whether the use of the Oncotype DX DCIS score can guide delivery of radiation in~     women with low to moderate risk DCIS who have had breast conserving surgery~   "
61120|NCT02766868|"~     Patients with refractory and relapse lymphoblastic leukemia had poor outcome even with marrow~     ablative conditioning mostly standard iv-Bu-Cy or Cy-TBI. In this study, we focus on a new~     treatment strategy with high-dose chemotherapy regimen consisting of~     fludaraibine+cytarabine+cyclophosphamide+etoposide followed by reduced intensity condiotning~     regimen consisting of fludarabine, busulfan and post-infusion cyclophophamide.~   "
61121|NCT02766855|"~     The aim of this study is to evaluate the efficacy of topical cysteamine eye drops in the~     treatment of corneal cystine crystals deposits in patients with nephropathic cystinosis.~   "
61122|NCT02766842|"~     Diagnosis of lesions of pancreas, the upper gastrointestinal tract, as well as adjacent~     structures, such as lymph nodes, is still showing advancements especially with the increased~     use of endoscopic ultrasound. Endoscopic ultrasound-guided fine needle aspiration and fine~     needle biopsy (EUS-FNA/FNB) have become mainstay diagnostic techniques for these lesions. The~     purpose of the study is to compare between the currently used, ProCore needles and the new~     biopsy needle, SharkCore, for the histological diagnosis and evaluation of lesions.~   "
61123|NCT02766829|"~     The study aimed to compare successful spinal needle placement between crossed leg sitting~     position and traditional sitting position in patients underwent urology surgery.~   "
61124|NCT02766816|"~     Bilthoven Biologicals has developed a new bivalent oral polio vaccine (bOPV) containing World~     Health Organization (WHO) approved Sabin strains of poliovirus type 1 and type 3. This study~     will assess non-inferiority of bOPV manufactured by BBio to that of licensed bOPV. This study~     will also assess lot-to-lot consistency among three lots of BBio bOPV.~   "
61125|NCT02766803|"~     Polycystic ovary syndrome (PCOS) is the most common endocrinopathy affecting women of~     reproductive age. Hyperandrogenism is the central feature of PCOS. Studies on isolated~     ovarian theca-interstitial cells indicate that resveratrol, a natural polyphenol, reduces~     androgen production.~      This study is designed to evaluate the endocrine and metabolic effects of simvastatin and~     resveratrol on PCOS.~      Methods: A randomized (1:1) double-blind, placebo-controlled trial will evaluate the effects~     of administering 20 mg of simvastatin daily and 500 mg of resveratrol daily, or administering~     20 mg simvastatin and the placebo to women with PCOS at an academic hospital. PCOS is defined~     according to the Rotterdam criteria. Evaluations are performed at baseline and repeated after~     3 and 6 months of treatment. The main outcome is a change of the serum total testosterone and~     the fasting insulin level.~   "
61126|NCT02766790|"~     TA-65 MD® is pure, natural, plant-based compound that can help maintain or rebuild telomeres.~     A telomere is a region of repetitive DNA at the end of a chromosome, which protects the end~     of the chromosome from deterioration. They shorten during cell division and eventually signal~     an irreversible state of growth arrest known as cellular senescence. The length of a person's~     telomeres is an indicator of his or her overall health status; short telomeres have been~     associated with cellular aging and dysfunction.~   "
61127|NCT02766777|"~     A study of the safety of Lubiprostone in pediatric subjects aged ≥ 6 Years to < 18 years~     diagnosed with Functional Constipation~   "
61128|NCT02766764|"~     Two hundred and thirty women with expected poor ovarian response undergoing IVF/ICSI will be~     randomly divided into 2 equal groups using computer generated random numbers. Group 1 will~     receive DHEA 25 mg (DHEA 25mg, Natrol , USA) t.d.s for 12 weeks before starting IVF/ICSI~     cycle in addition to Growth hormone (GH; Somatotropin, Sedico, Egypt) 4 IU on day 6 of human~     menopausal gonadotropin (hMG) stimulation in a daily dose of 2.5 mg subcutaneous (sc) until~     the day of human chorionic gonadotropin (hCG) triggering Group 2 will receive an oral placebo~     t.d.s. daily for 12 weeks before ICSI in addition to a sc placebo similar to GH daily from~     day 6 of stimulation until the day of hCG trigger.~   "
61129|NCT02766751|"~     This study is designed to look at two different programs that may help people who are HIV+~     and have pain and depression. The investigators are trying to understand how to help people~     learn to live better lives even with these chronic illnesses.~   "
61130|NCT02766738|"~     This study aims to test which of three exercise programs, previously demonstrated valuable~     for residential aged care adults, has the greatest benefit for walking speed and the~     spatiotemporal parameters that define it. The programs to be included are:~        1. The GrACE program and~        2. The GrACE plus Gait specific training.~   "
61131|NCT02766725|"~     The aim of this study was to develop and characterize in situ thermosensitive gels for the~     vaginal administration of sildenafil as a potential treatment of the endometrial thinning~     that occurs as a result of the use of clomiphene citrate in induction of ovulation in women~     with World Health Organization type II EU gonadotrophic anovulation.~   "
61132|NCT02766712|"~     This is a two arm randomized, paired prospective study comparing the percentage of time spent~     above Contact Force (CF), Force Time Integral (FTI) and other lesion parameters in the~     setting of pacing versus non-pacing. This study is designed to compare the percentage of time~     spent above CF 10 grams between paced and non-paced lesions at 15 pre-determined lesion~     locations.~   "
61133|NCT02766699|"~     The purpose of the Cerebral EDV study is to determine the safety and tolerability of~     EGFR(V)-EDV-Dox in order to establish the best dose level to be used in future studies. The~     study will also examine the body's immune response to EGFR(V)-EDV-Dox and assess if it is~     effective in the treatment of patients with recurrent glioblastoma multiforme (GBM).~   "
61134|NCT02766686|"~     ProtoChoice-P is a prospective multicenter trial to evaluate proton therapy in patients~     suffering from prostate cancer. Primary aim of the study is a decrease of moderate or severe~     genito-urinary or intestinal side effects (Common Terminology Criteria for Adverse Events~     (CTCAE) 4.0 grade 2 or higher) by the use of proton therapy. Secondary endpoints contain~     assessment of quality of life, biochemical recurrence and recurrence free survival as well as~     overall survival and economic comparison between photon and proton therapy.~   "
61135|NCT02766673|"~     Currently several dose schedules of Albuterol are administered via nebulization to infants in~     the neonatal and infant intensive care unit (N/IICU). As Albuterol is not FDA approved for~     this population (under 2 years) there is no standard recommended dose. Aerosolized Albuterol~     is one of the most widely used therapies that are utilized for infants with chronic lung~     disease. The common practice in the N/IICU is weight base dosing of all medications. This~     contradicts the aerosol science recommendations, which advise not to titrate doses by weight~     as the patient naturally self-regulates their dose according to the change in minute~     ventilation with age. In addition, the wide use of aerosolized Albuterol in the infant with~     Bronchopulmonary Dysplasia (BPD) has little current evidence of efficacy in this disease.~     Understanding the appropriate dose for effective treatment as well as the indication for use~     in the BPD population would provide the clinician with useful guidelines.~      The investigators propose to analyze the safety and efficacy of aerosolized albuterol in~     infants with BPD comparing the recommended dose per aerosolization literature with the common~     dosing practices at The Children's Hospital of Philadelphia (CHOP) as well as placebo.~   "
61136|NCT02766660|"~     The aim of the study is to compare the measurements of retinal nerve fiber layer (RNFL),~     macula and optical disc parameters obtained by optical coherence tomography (OCT), and~     intraocular pressure (IOP) between the patients with thyroid-associated ophthalmopathy (TAO)~     and healthy controls.~   "
61137|NCT02766647|"~     This is a study comparing two study drugs, Filgrastim Hospira and Neupogen®. Neupogen® is~     approved by the US Food and Drug Administration (FDA) to treat low numbers of specific kinds~     of white blood cells (WBC) known as neutrophils. This type of white cell is important in~     fighting infections. A low neutrophil count is known as neutropenia. Both drugs work by~     increasing the number of neutrophils that are produced in the body.~      This is important for patients who have low neutrophils due to chemotherapy, other treatments~     such as bone marrow transplant or certain other conditions with symptoms/problems related to~     low neutrophil counts. The main aim of the study is to test how Filgrastim Hospira works in~     the body compared to Neupogen®.~   "
61138|NCT02766634|"~     This is a study comparing two study drugs, Filgrastim Hospira and Neupogen®. Neupogen® is~     approved by the US Food and Drug Administration (FDA) to treat low numbers of specific kinds~     of white blood cells (WBC) known as neutrophils. This type of white cell is important in~     fighting infections. A low neutrophil count is known as neutropenia. Both drugs work by~     increasing the number of neutrophils that are produced in the body.~      This is important for patients who have low neutrophils due to chemotherapy, other treatments~     such as bone marrow transplant or certain other conditions with symptoms/problems related to~     low neutrophil counts. The main aim of the study is to test how Filgrastim Hospira works in~     the body compared to Neupogen®.~   "
61139|NCT02766621|"~     The purpose of this study is to determine the safety, tolerability and pharmacokinetics of~     escalating single and multiple intravenous (IV) infusions and subcutaneous (SC) injections of~     PF 06823859 in healthy subjects.~   "
61141|NCT02766595|"~     Children referred for routine EEG studies for suspected absence seizures will be asked, upon~     caregiver's informed consent, to perform 3 minutes of hyperventilation both in the supine~     position and while sitting up. We aim to demonstrate that hyperventilation is more effective~     in eliciting absence seizures in a sitting position than while lying down.~   "
61142|NCT02766582|"~     Phase II single arm, open label, nonrandomized study. The aim of our study is to assess the~     Progression Free Survival (PFS) in suboptimally cytoreduced epithelial ovarian/ primary~     peritoneal/ fallopian tube cancer patients treated with the novel combination of carboplatin~     every 21 days (triweekly) /weekly paclitaxel IV with pembrolizumab IV followed by maintenance~     pembrolizumab IV.~   "
61143|NCT02766569|"~     The IRFACODE II study will evaluate the performance and safety of the Occlutech® Flex II~     device in patients with closure of secundum atrial septal defects (ASD II).~   "
61144|NCT02766556|"~     The present study was designed to test the hypothesis that dexmedetomidine added to~     ropivacaine for interscalene brachial plexus blocks for elective shoulder surgery would~     enhance the duration and effect of analgesia when compared with ropivacaine alone, and their~     influence on serum IL-6, cortisol, IL-1beta, IL-8, and substance p.~   "
61145|NCT02766543|"~     A prospective, multi-center, single-arm study, planned in 110 patients. The primary objective~     of the study is to further evaluate the safety and efficacy of a magnetic resonance imaging~     (MRI)-guided transurethral ultrasound therapy system (TULSA-PRO) intended to ablate prostate~     tissue of patients with localized, organ-confined prostate cancer.~   "
61146|NCT02766530|"~     The investigators will use integrated PET/MR for the goals below:~        1. Use of PET-guided proton MRS (MR spectroscopy) and DCE MRI (dynamic contrast-enhanced~          MRI) for patients who will receive NAC (neoadjuvant chemotherapy) for breast cancer to~          monitor treatment response.~        2. Use of dynamic and static PET to monitor treatment response for NAC, and to investigate~          the correlation of PET results versus MRS, DCE MRI.~        3. Compare clinical staging by PET/MR and by clinical assessment.~        4. On pre-chemotherapy studies, to investigate the association of molecular marker status~          with the dynamic and static PET, MRS and DCE MRI parameters.~   "
61147|NCT02766517|"~     This is a study of participants with a diagnosis of migraine who completed another clinical~     trial known as I5Q-MC-CGAB (CGAB) (NTC02163993). In CGAB, participants received either~     LY2951742 or placebo. This study will evaluate how certain biomarkers may be related to the~     participant's response in CGAB. The study will last about five days.~   "
61148|NCT02766504|"~     the study aims to evaluate the role of airway ultrasound as a new evolving modality in~     assessment and management of airway in surgical patients~   "
61149|NCT02766491|"~     Cerebral palsy (CP) has a prevalence of 1.5-3 per 1000 live births, making it the most common~     neurological disorder among children in Europe. One of the most frequently observed problems~     in CP is hypertonia, i.e. increased muscle tension, which can result in contractures.~     Stretching therapies are widely used as a treatment for contractures, but with highly~     variable success. Therefore, efforts are needed to improve the efficacy of stretching~     interventions. The investigators hypothesise that increasing the stiffness of the tendon~     relative to the muscle, by resistance training, prior to stretching will improve the efficacy~     of stretching interventions in children with CP. In a RCT design the investigators will~     compare a group of children receiving a combined strengthening-stretching intervention of the~     calf muscle to a control group receiving conventional stretching exercises in combination~     with upper limb exercises. Outcome measures will include muscle-tendon structure and gait~     analysis to assess functional improvements. This research will improve the understanding of~     muscle responses to stretching interventions in children with CP and can lead to more~     effective stretching therapies.~   "
61150|NCT02766478|"~     Genistein is a natural supplement that comes from soy. The purpose of this study is to see if~     genistein has any effect on preventing or reducing heart disease and diabetes risk in men~     receiving Androgen Deprivation Therapy for prostate cancer. A combination of nutritional~     measures, blood markers and imaging tools will assess body composition, lipid levels and~     insulin resistance. Information from this pilot study will increase understanding of~     interventions which may prevent or reduce health risks during prostate cancer treatment. This~     project involves 24 men who will receive androgen deprivation therapy for prostate cancer.~   "
61151|NCT02766465|"~     This is a clinical trial that will compare survival and sickle related outcomes in~     adolescents and young adults with severe sickle cell disease after bone marrow~     transplantation and standard of care. The primary outcome is 2-year overall survival.~   "
61152|NCT02766452|"~     The objectives of this study were to evaluate the effect of a preoperative educational DVD on~     parents' knowledge acquisition, participation and anxiety related to their child's care in~     the recovery room (RR). It also aimed at evaluating the DVD in terms of children's~     postoperative distress, pain, analgesic requirements and length of recovery.~   "
61153|NCT02766439|"~     between March 2013 and March 2014, Rhupus patients were enrolled to receive a 25-mg~     etanercept injection subcutaneously twice a week. The follow-up time of the study was 24~     weeks.~   "
61154|NCT02766426|"~     Sincev the adipose tissue as been identified as a metabolic active tissue that produces and~     regulates pro-inflammatory factors, the investigators studied the relationship between~     cytokine changes and maternal body composition.~      The investigators evaluated plasmatic pro- and anti-inflammatory cytokines levels in pregnant~     women with BMI >25 Kg/m^2 undergoing a lifestyle change program, and if this is related with~     changes in body composition.~      Women enrolled in the study were provided nutritional advices about lifestyle: a proper~     nutrition and a constant physical activity (30 minutes/day, 3 times/week, according to the~     American College of Obstetricians and Gynecologists Guidelines) in an integrated counselling~     with a dietitian and a gynaecologist, both attendant since the enrollment.~      Plasma pro- and anti-inflammatory markers were investigated at enrollment (9-12 weeks) and at~     36-38 weeks.~      Furthermore, the investigators used the bioimpedance analyzer to evaluate changes of body~     composition (i.e. fat mass and fat free mass) at first and third trimester.~   "
61186|NCT02765997|"~     This is an open label, interventional, randomized phase II trial comparing StemRegenin-1~     (SR-1) cultured umbilical cord blood (experimental arm) to unmanipulated umbilical cord blood~     (standard of care arm) transplantation after a myeloablative CY/FLU/TBI conditioning. A 2:1~     randomization will be employed with a higher chance of being assigned to the experimental~     arm.~   "
61155|NCT02766400|"~     Individuals with cognitive impairments after stroke sustain significant disability in their~     daily tasks, and account for a significant proportion of stroke-related healthcare costs.~     This loss of independence is costly because individuals with stroke-related cognitive~     impairments require more rehabilitation and more resources to support their living, whether~     in institutional or community settings. The proposed study examines the effects of directed~     and guided training on the recovery of independence with daily activities in adults with~     stroke-related cognitive impairments in acute rehabilitation. The investigators predict that~     patients in both groups will demonstrate significant improvement in independence with daily~     activities in the first 12 months after rehabilitation admission, but that patients who~     receive guided training will demonstrate significantly more improvements than patients who~     received directed training.~   "
61156|NCT02766387|"~     Lower limb amputation (LLA) is a major public health problem, with significant human and~     financial impact. Epidemiological data remain scarce in the literature. The primary objective~     of the equipment of lower limb amputees is to give a walking ability and autonomy that are~     closest to the previous state before the amputation. About microprocessor-controlled~     prosthetic knees (MPKs), there are currently three in France who benefit from support by~     health insurance : 3C100 knee C-leg (Otto Bock HealthCare, Duderstadt, Germany), the Rheo~     Knee (Ossur, Reykjavik, Iceland) and knee HYBRID 1P360 (Proteor, Saint Apollinaire, France).~     These prostheses have the common feature of being equipped with a single-axis prosthetic~     knee, controlled by a microprocessor, wich allows to adapt instantly to the user's walking~     speed changes. They are indicated in the proximal amputations of the lower limbs from knee~     disarticulation included. Their prescription can only be made by a doctor of Physical~     Medicine and Rehabilitation. These prostheses are subject to four criteria attribution and~     reimbursement by the List of Products and Services Refundable (LPPR = Liste des Produits et~     Prestations Remboursables). This criteria are the ability to: have a walking speed greater~     than or equal to 4 km/h, walk 2km continuous, descend an inclined slop of 15% and to walk~     down the stairs step by step. These criteria must be validated after a minimum trial period~     of 15 days.~      These attribution criteria raise the question today of how they are measured, no~     recommendation defining this procedure. While many standardized assessment tests of different~     gait parameters are available and used in clinical research, the attribution criteria are not~     being built in reference to these tests.~      The overall objective of the study is to evaluate the diagnostic value of two simple clinical~     tests, the 2 and 6 minutes walk tests, to assess functional performance in patients with~     transfemoral amputees with a microprocessor-controlled Prosthetic Knees (MPKs).~   "
61157|NCT02766374|"~     The goal of this research study to see whether biofeedback therapy helps treat asthma, and if~     so, how it works. Biofeedback is a treatment method that can teach how to bodily control.~     Biofeedback is widely used to help people relax. In this study however, the investigators~     want to learn if a specific type of biofeedback actually improves asthma in a way that might~     allow the reduction or elimination of other controller treatments like~     inhaled-corticosteroids.~   "
61158|NCT02766361|"~     The study consists of a clinical trial comparing a new structured group intervention,~     denominated Cognitive-Behavioral Rehabilitation, to treatment as usual (TAU) for bipolar~     patients. The new approach is a combination of cognitive behavioral strategies and cognitive~     rehabilitation exercises, consisting of twelve weekly group sessions of 90 minutes each. To~     be included in the study, patients must be diagnosed with bipolar disorder, type I or II, be~     18 to 55 years old, in full or partial remission and have an IQ of at least 80. A~     comprehensive neuropsychological battery, followed by mood, social functioning and quality of~     life assessments will occur in three moments: pre and post-intervention and after 12 months.~   "
61159|NCT02766348|"~     Patients in group A will receive DC-CTL treatment and chemotherapy. Patients in group B will~     receive only chemotherapy.~   "
61160|NCT02766335|"~     This phase II trial studies how well durvalumab works in treating patients with stage IV~     squamous cell lung cancer that has come back after previous treatment. This is a non-match~     sub-study that includes all screened patients not eligible for a biomarker-driven sub-study.~     Monoclonal antibodies, such as durvalumab, may be able to shrink tumors. Durvalumab may be~     effective in treating patients with squamous cell lung cancer.~   "
61161|NCT02766322|"~     The investigators wish to study the effects of alcohol on three forms of bariatric surgery,~     Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy (SG) and laparoscopic adjustable gastric~     banding (LAGB). The surgery is not part of the clinical trial. If insurance does not cover~     the procedure, then the patient is responsible for payment of the surgical process. The~     investigators are doing pre and post surgery testing to provide a better understanding of the~     effect of bariatric surgery-induced weight loss on 1) alcohol absorption, distribution and~     elimination from the body, 2) the effects of alcohol on mood, and 3) the effects of alcohol~     on driving.~   "
61162|NCT02766309|"~     This study aims to examine the relation between health status and self-assessment of health~     condition, their relation to healthcare services utilization, and also to identify the~     profile of those who assess their health condition as mediocre to poor in general population~     and according to nationality.~   "
61163|NCT02766296|"~     PTSD is characterized by recurrent intrusion of trauma-related memories and images that cause~     significant distress and impairment to the affected individuals. The current project aims to~     examine whether computerized emotional working memory training (eWMT) can help improve~     working memory capabilities and reduce trauma-related emotional symptoms among individuals~     with elevated trauma-related symptoms. Participants will be randomly assigned to one of the~     two computerized training programs. At baseline, post-training, and 1-month follow-up,~     participants will be assessed with respect to their emotional symptoms and working~     memory-related cognitive performance. Pending successful outcomes, this study will provide~     important knowledge that will guide the future efforts to develop an effective, accessible,~     and cost-efficient intervention program.~   "
61164|NCT02766283|"~     To investigate the incidence of detected hypothyroidism after iodinated contrast exposure in~     pediatric patients from birth to 3 years of age (inclusive) in a routine clinical practice~     setting.~   "
61165|NCT02766270|"~     The management of lower-grade gliomas (Diffuse low-grade and intermediate-grade gliomas, WHO~     II and III) is largely based on surgery followed by radiotherapy. Recent studies showed that~     lower-grade glioma patients with IDH wild-type (IDH-wt) and TERT promoter mutation~     (TERTp-mut) had dismal clinical outcomes. These results suggested that current treatment~     strategies are not adequate for this subtype of lower-grade glioma.~      The present study aims to examine the efficacy and safety of concurrent chemoradiotherapy~     with temozolomide followed by adjuvant temozolomide for lower- grade glioma patients with~     IDH-wt and TERTp-mut.~   "
62695|NCT02746250|"~     The aim is to investigate muscle soreness and stiffness in patients with Chronic or Frequent~     Episodic Tension Type Headache before and after treatment with amitriptyline - and to compare~     the results with healthy individuals.~   "
61166|NCT02766257|"~     Long surgical wait-times and limited hospital capacity are common obstacles to surgical care~     in many countries in sub-Saharan Africa (SSA). Ambulatory surgery might offer a solution to~     these problems. The aim is to study the introduction of ambulatory surgery in a pediatric~     hospital in SSA.~      This is a cross-sectional descriptive study which took place over 6 months. It includes all~     the patients assigned to ambulatory surgery in the Pediatric University Hospital in~     Ouagadougou, Burkina Faso.~   "
61167|NCT02766244|"~     Three patients were recruited for assessment of ICG fluorescence in burns.~   "
61168|NCT02766231|"~     Type & Design:~      Post-market, international, multicentre Prospective, parallel groups, open-label, baseline~     controlled~      Objectives:~        1. Assessment of clinical, radiographic and patient-reported outcomes of Physica CR and PS~          designs~        2. Incidence of adverse events and identification of possible risk factors for~          unsatisfactory results~        3. Mid-term survivorship of the implants~   "
61169|NCT02766218|"~     The purpose of this observational study is to conduct 18-, 24-, and 36-month assessments with~     mother-toddler dyads who participated in a study that is testing the effects of a~     multicomponent lifestyle intervention as a means to prevent excessive gestational weight gain~     in obese women. Specifically, dyads will be invited to participate in home-based assessments~     to videotape an evening meal, have anthropometric measures taken, and complete study~     questionnaires. The overall goal is to understand factors related prospectively to responsive~     feeding between mothers and toddlers at 18 months; determine whether responsive feeding at 18~     and 24 months predicts change in zBMI and adiposity from 18-36 months; and explore which~     factors are most strongly predictive of child zBMI change from birth to 36 months.~   "
61170|NCT02766205|"~     The aim of the proposed study is to identify predictors of covert atrial fibrillation (AF) in~     Embolic Stroke of Undetermined Source (ESUS) patients and develop a prognostic score for the~     identification of covert AF in this population.~   "
61171|NCT02766192|"~     Background: The poor prognosis and public health burden of PTSD necessitates the development~     of more effective and broader treatment approaches. In the etiopathogenesis of PTSD, trauma~     memories become ingrained into key brain areas through conditioned learning and are triggered~     by various situations of daily life. The brain glutamate system plays a key role in the~     process of trauma learning and trauma memories via long-term potentiation. Ketamine~     administration modulates the glutamate system and has been used in the treatment of~     depression and PTSD. Previous studies demonstrate that a single low dose of ketamine rapidly~     improves symptoms of refractory PTSD and treatment resistant depression. Unfortunately the~     observed response is short-lived (4-7 days, maximum up to 2 weeks) and multiple doses often~     produce unacceptable side effects. TIMBER (Trauma Interventions using Mindfulness Based~     Extinction and Reconsolidation for trauma memory) psychotherapy, is a manualized and~     translational mindfulness based cognitive behavioral therapy specifically designed to target~     trauma memories and their expressions in PTSD patients. The placebo controlled pilot study~     examined the efficacy of a protocol combining a single infusion of low dose ketamine~     (0.5mg/kg) and TIMBER psychotherapy in subjects suffering from chronic PTSD. The objective of~     this pilot study was to optimize and individualize treatment of chronic PTSD using a rapid,~     effective, trauma specific, user friendly and inexpensive approach that uses cutting edge~     psychopharmacological combined with novel psychotherapeutic approaches.~      Methodology: The randomized, double blind, placebo-controlled pilot study used a crossover~     design. Ten subjects with refractory PTSD were assigned to one of two arms: one arm (n=5)~     received combined ketamine infusion and TIMBER therapy (TIMBER-K arm) and the second (n=5)~     received combined placebo (normal saline) infusion and TIMBER therapy (TIMBER-P arm). All 10~     subjects received a short version of TIMBER therapy after 10 minutes of onset of the infusion~     in which reactivation of trauma memories was initiated in a controlled manner using~     standardized scales and scripted narrative of the index trauma. This was followed by a~     standardized mindfulness based cognitive therapy module to quickly de-escalate the arousal~     symptoms followed by induction of detached observation and reappraisal of the trauma~     experience. After completion of the 40-min infusion, all subjects were trained on the full~     version of TIMBER therapy using methods of mindfulness based graded exposure therapy and a~     twice-daily schedule of home practice was initiated. The investigators are currently in a~     process of recruiting fifty more subjects to examine the effects in a larger sample.~   "
61172|NCT02766179|"~     The objectives of this study is to compare short-term outcomes of CPAP and Adjustable~     thermoplastic oral appliance in the treatment of obstructive sleep apnea. Study design is a~     randomized cross-over trial during 6-week period of each treatment in 50 patients. Primary~     outcomes are quality of life, degree of sleepiness, and severity of OSA determined by FOSQ~     ESS, and AHI or RDI, respectively.~   "
61173|NCT02766166|"~     CHAOS is based on the investigator's new and exciting results from pre-clinical and large~     longitudinal multi-center observational clinical studies of critically ill patients and~     asymptomatic community-based adults with little or no advanced disease.~      By integrating approaches from the physical, biological, computational, statistical and~     clinical sciences, this observational study will test the hypothesis that early diagnosis of~     subclinical signatures of critical illness encoded within physiological signals complements~     conventional clinical predictors by providing unique prognostic insight.~      The primary goal is to reduce mortality, morbidity and complications by early identification~     of individuals with brewing subclinical critical illness and adverse events before overt~     clinical presentation (e.g., cardiac arrest, arrhythmias, hemorrhage, respiratory failure,~     circulatory collapse). This will provide the necessary lead time for healthcare providers to~     deliver early, more effective and/or preventive therapies. Through innovative approaches,~     CHAOS also meets the challenge of medical errors to reduce missed diagnosis, misdiagnosis,~     preventable harm and variability in provider adherence to best practice guidelines.~      The goal is to validate predictive algorithms and identify subclinical signatures of illness,~     ranging from asymptomatic adults in the community to very sick patients in the hospital. The~     overall goal is to make healthcare more precise, effective, efficient, safe and timely while~     reducing costs, preventable harms and adverse events.~   "
61187|NCT02765984|"~     Trans vaginal ultrasound with a partially full bladder will be done at gestational age~     earlier than 10 weeks to assess the site of intrauterine gestational sac to the endometrial~     cavity and the distance between the implantation site and the internal cervical os . Doppler~     assessment of the retrochorionic blood flow at the area behind the maximum chorionic tissue~     to detect resistance index.~   "
61188|NCT02765971|"~     540 consented women for being enrolled in this clinical trial and candidates for elective~     cesarean section will be divided into 3 groups:~        -  Group A, 180 women will receive sugarless gum after their operating room discharge by 3~          hours for at least half an hour at two hours interval.~        -  Group B, 180 women will receive laxatives after their operating room discharge by 3~          hours.~        -  Group C, 180 women as control group, they will not receive neither gum nor oral fluids.~          They will be on intravenous fluid. starting oral fluids after hearing intestinal sounds~          .~   "
61353|NCT02763813|"~     Monocentric comparative group study comparing the efficacy and short-term tolerance of a~     propulsion type oral appliance (Herbst) with a retention type device (ORM) used in the~     treatment of sleep apnea syndrome. The investigators hypothesized both appliances would be~     equally effective and tolerated.~   "
61174|NCT02766153|"~     Myeloproliferative disorders (MPD) include chronic myeloid leukemia (CML) (Ph +) and~     essential thrombocythemia (ET), the polycythemia vera (PV), myelofibrosis (MF) called SMP Ph.~     CML is the ultimate model of carcinogenesis. SMP is a characterized by a malignant monoclonal~     proliferation of a pluripotent hematopoietic progenitor determined by the presence of a~     balanced translocation between chromosomes 9 and 22 (Ph chromosome) which leads to major~     changes of a large number of cell functions. Investigators now believe that within the bone~     marrow exist two types of hematopoietic niches' niche osteoblastic / endosteal and vascular~     niche, controlling the maintenance and differentiation of hematopoietic stem cell pool. The~     endosteal niche, is a hypoxic region near the endosteal trabecular, which provides protection~     to deeply dormant stem cells. Data from the literature suggest that in the SMP, especially~     CML, the interaction of malignant stem cells with the microenvironment niche Endosteal could~     favor their survival and resistance to treatment. The therapeutic management of CML was upset~     by the use of tyrosine kinase inhibitors (TKIs). However, despite these advances, even in~     situations of undetectable residual disease, it has been observed relapses of the disease~     stopped TKI leaving suggest that there is a resistance of leukemic stem cell to TKI.~      Work in the group Bipoa Bio Engineering and Pathophysiology Osteo-Articular helped develop~     a 3D model of ex vivo bone formation, which can mimic the endosteal niche. the goal is to~     apply this model to the SMP of hematopoiesis by referring to normal hematopoiesis. it will be~     tested the hypothesis that the endosteal ex vivo recess of the 3D modeling allows to~     highlight a special interaction can promote the persistence of the leukemia stem cell despite~     the use of effective therapies.~   "
61175|NCT02766140|"~     The present trial will be performed to evaluate whether SHR1020 in combination with docetaxel~     in patients with Local Advanced or Metastatic or recurrent Non Squamous NSCLC is more~     effective as compared to placebo in combination with docetaxel. A secondary aim is to obtain~     safety information as well as information on quality of life of patients treated with SHR1020~     in combination with docetaxel.~   "
61176|NCT02766127|"~     Aim: To compare the desensitizing capacity of Vertise Flow™ (VF), a new self adhering~     material, in the treatment of dentine hypersensitivity (DH) in patients who are xerostomic~     due to radiotherapy for head and neck cancer.~      Methods: A total of 17 patients were selected for the study. The study was conducted as a~     split-mouth randomized clinical trial comparing: 1) VF 2) Universal Dentin Sealant (UDS), 3)~     Clearfil Protect Bond (CPB) and 4) Flor-Opal® Varnish (FOV). Basal and stimulated salivary~     flow was recorded for each patient according to the method described by Sreebny. The pain~     experience was generated by a cold stimulus directly to a sensitive tooth surface and~     assessed using the Visual Analogue Scale (VAS). The response was recorded before the~     application of the materials (PRE-1), immediately after (POST-1), at 1-week (POST-2), 4-weeks~     (POST-3) and 12-week controls (POST-4).~   "
61177|NCT02766114|"~     Carpal tunnel release through dorsal wrist crease Mini Transverse incision, about 1.5 cm~     length.~   "
61178|NCT02766101|"~     The purpose of this study is to examine whether an exergaming, aerobic physical education~     (PE) curriculum is acceptable and elicits improvements in behavioral self-regulation and~     classroom functioning among children with behavioral health challenges attending a~     therapeutic day school. After following an approved consent/assent process, children~     attending the school were randomized by classroom to take part in either 7 weeks of the~     experimental PE curriculum, or 7 weeks of the standard PE curriculum; after a 10 week washout~     period, children then crossed over into the other arm.~   "
61179|NCT02766088|"~     The purpose of this study is to describe the burden of DENV illness among household members~     aged 6 months to 50 years of selected communities in Latin America and Southeast Asia.~   "
61180|NCT02766075|"~     The aim of this pilot study is to establish whether a Supervised TAVR Exercise Program (STEP)~     can safely improve the frailty status in patients with symptomatic severe aortic valve~     stenosis prior to undergoing transcatheter aortic valve replacement (TAVR).~   "
61181|NCT02766062|"~     The purpose of this study is to investigate propofol versus sevoflurane anesthesia on the~     effects of early postoperative cognitive function in elderly patients with metabolic~     syndrome.~   "
61182|NCT02766049|"~     The aim of this study was to assess tolerability and safety of three different formulations~     of an anti-HIV immunotherapy based on autologous dendritic cells (DCs) pulsed with HIV~     chemically inactivated with Aldrithiol™-2 (AT-2). Patients were chronically infected with~     HIV, naïve for antiretroviral drugs. A possible immunological and virological favorable~     impact was also assessed.~   "
61183|NCT02766036|"~     The aim of this study is to determine the impact of Propolis on proteinuria reduction and~     protection of the glomerular filtration rate in chronic renal failure patients.~   "
61184|NCT02766023|"~     This Phase 2b trial is designed to provide a screening evaluation for the hypothesis that,~     following a 5-day treatment with MetroGel® to treat BV, L. crispatus CTV-05 (LACTIN-V, Osel,~     Inc.) administered at 2 x 10^9 cfu/dose using a vaginal applicator reduces the 12-week~     incidence of BV recurrence when compared to placebo. The primary objectives of this study~     are: 1) To estimate the efficacy of repeated doses of LACTIN-V (2 x 10^9 cfu/dose) as~     compared to placebo in preventing BV recurrence by 12 weeks following treatment of BV with~     MetroGel vaginal gel (MetroGel). 2) To assess the safety of LACTIN-V over 24 weeks by~     comparing the incidence of AEs between individuals randomized to LACTIN-V or placebo.~   "
61185|NCT02766010|"~     1. Aim- This study is aimed to access the accuracy of TensorTip MTX device measuring~          Hemoglobin A1C, Oxygen Concentration and Saturation ,Carbon Dioxide, Blood pH,~          Hemoglobin, Hematocrit, Red Cells Count, platelets, Blood Urea Nitrogen, Sodium,~          Potassium, Chloride, total bilirubin, cholesterol (HDL, LDL), Serum Creatinine,~          Peripheral Pulse Rate, Blood Pressure, Mean Arterial Pressure, cardiac output, cardiac~          index, stoke volume and blood gases compared with the simultaneous results from hospital~          references device (when available)~        2. Hypothesis- Human physiological biomarkers may be measured from the color distribution~          of the internal or external (skin) tissue. The technology of the TensorTip device is~          based on the color distribution of the peripheral blood tissue, which enables the~          measurement of certain biomarkers and vital signs under consideration~   "
61256|NCT02765087|"~     The purpose of this study is to determine the diagnostic utility of the device 'Electronic~     Nose' for Pleural TB, which is a Extra pulmonary TB form, compared with pleural biopsy, the~     current gold standard.~   "
61189|NCT02765958|"~     Sleep is a fundamental need for human and is associated with the working performance and the~     disease occurrence. Furthermore, the amount of people with sleep disorder or apnea increased~     largely. Thus, the analysis of sleep stages and the measurement of sleep quality became more~     important recently. In clinical settings, the analysis of daily sleep quality depends on~     actigraphy and sleep log. However, the uses of actigraphy and sleep log are not really~     convenient for patients. In this trial, the investigators will measure the subjects' ECG~     signal and movement using a portable ECG device with motion sensor. On the other hand, the~     sleep stages are also obtained from the current wide-established measurement-~     polysomnography. The ECG signals, movements, and sleep stages will be analyzed by our~     algorithm of artificial neural network. Then, the investigators can obtain the preliminary~     analysis of sleep quality can be obtained by using ECG device with our algorithm. It is~     helpful for doctors to realize the patent's sleep quality quickly~   "
61190|NCT02765945|"~     This is the second phase of a study designed to determine the immunological effects of~     long-term exercise on risk factors for ischemic heart disease (phase 1) and osteoporosis~     (phase 2). The results indicate that six months of moderate intensity exercise reduces bone~     resorption and increases the secretion of anti-osteoclastogenic cytokines by peripheral blood~     mononuclear cells.~   "
61191|NCT02765932|"~     This is a prospective study looking at the impact of psychosensory therapy and how it can~     diminish pain and consumption of pain medications. The primary study objective is to evaluate~     the change in Visual Analogue Score (VAS) score assessing for pain from Baseline, every day~     of inpatient stay, 7 days after leaving hospital (via phone), and 3 months post-op(via phone)~     and to correlate the psychosensory therapy and overall use of pain medications/narcotics.~   "
61192|NCT02765919|"~     The purpose of this study is to compare two diffrent brachytherapy treatment option in~     locally advanced carcinoma of uterine cervix. Brachytherapy of two fractions of 9 Gy is~     effective in locoregional control and more convenient in terms of cost and time than 7 Gy~     brachytherapy of 3 fractions in management of locally advanced carcinoma of cervix.~   "
61193|NCT02765906|"~     Preeclampsia is a life-threatening condition unique to pregnancy which occurs in 5-8% of all~     pregnancies. It contributes to a large proportion of maternal mortality worldwide and these~     deaths largely result from delayed diagnosis.~      A number of studies have shown that patient knowledge about preeclampsia is poor and that~     patient education can improve patient awareness. The investigators would like to find out~     what type of patient education is most effective. The investigators propose a three arm~     randomized controlled trial (RCT) where the first arm will receive a graphic card depicting~     signs and symptoms of preeclampsia, the second arm will watch an educational video on~     preeclampsia, and the third arm will have no visual form of patient education; they will be~     exposed only to the counseling they receive with their routine prenatal care. The card and~     video were both developed by the Preeclampsia Foundation and in a prior RCT the card was~     shown to be a useful educational intervention. This study would expand on this previous data~     by comparing the graphic card to an informational video available on the Preeclampsia~     Foundation's website~     (http://www.preeclampsia.org/component/allvideoshare/video/featured/7-symptoms-every-pregnant~     -woman-should-know?Itemid=479). The effectiveness of this video has not yet been tested as an~     educational tool. Patients in the arm receiving the graphic card for educational intervention~     will be allowed to keep this card. Primiparous patients seen in the ambulatory prenatal~     clinic and Maternal Fetal Medicine (MFM) clinic will be enrolled at 18w0d-24w6d gestation. At~     the time of enrollment baseline preeclampsia knowledge, demographics, and patient anxiety~     before and after initial exposure to the educational interventions will be assessed. A follow~     up assessment of knowledge of preeclampsia will be obtained at 32-36 weeks gestation to~     measure retention of knowledge. Patient medical records will be reviewed for delivery~     outcomes which will be recorded and compared.~   "
61194|NCT02765893|"~     This is a prospective, comparative randomized study. Our study population includes women with~     pelvic organ prolapse undergoing a robotic assisted laparoscopic sacrocolpopexy.~      The two groups will include the study group, who will have their Foley catheter removed 6~     hours post-op, and the control group who will have an indwelling Foley catheter overnight.~     The two groups will be assigned according REDCap randomization system.~   "
61195|NCT02765880|"~     The main purpose of the study is to examine to which extent abnormalities in the dynamics of~     neural activities observed in patients with psychosis is related to difficulties at ordering~     simple visual stimuli and/or personal events.~   "
61196|NCT02765867|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic profile~     of an injection of RBP-6000.~   "
61197|NCT02765854|"~     This randomized phase II trial studies how well ixazomib and dexamethasone or ixazomib,~     dexamethasone, and lenalidomide work based on the presence of the rearrangement of a gene~     called nuclear factor of kappa light polypeptide gene enhancer in B-cells 2 (NFKB2) in~     treating patients with multiple myeloma that has returned after a period of improvement or~     does not respond to treatment. Ixazomib may stop the growth of cancer cells by blocking~     enzymes called proteasomes needed for cell growth. Drugs used in chemotherapy, such as~     dexamethasone, work in different ways to stop the growth of cancer cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. Lenalidomide~     may stimulate the immune system against cancer cells and may also prevent the growth of new~     blood vessels that tumors need to grow. It is not yet known whether ixazomib and~     dexamethasone, or ixazomib, dexamethasone, and lenalidomide are more effective in treating~     multiple myeloma.~   "
61198|NCT02765841|"~     This is a Phase 3 single-arm, open-label, international, multi-center clinical trial to~     evaluate the efficacy and safety of lomitapide in pediatric patients with HoFH who are~     receiving stable lipid-lowering therapy, including LDL apheresis. The study is comprised of a~     12-week Run-in Period, a primary 24-week Efficacy Phase, followed by an 80-week Safety Phase.~   "
61199|NCT02765828|"~     This purpose of this study is to determine if tongue strength and tongue ultrasound~     measurements differentiates patients with untreated late-onset Pompe Disease (LOPD) from~     patients with acquires/hereditary myopathies or neuropathies. It is hypothesized that~     abnormalities in tongue function and structure in patients with LOPD may be useful in~     discriminating this condition from others that have similar presentations.~   "
61200|NCT02765815|"~     This is a prospective, single-center, single-blinded, randomized, case-control study. The~     study is conducted by a single investigator at an orthopedic surgery institute, with a~     minimum 6 week post operative follow-up period of TKA patients who receive Exparel compared~     with the surgeon's standard method (detailed below) for pain management intraoperatively.~   "
61302|NCT02764476|"~     The purpose of this study is to design and test the safety and feasibility of virtual reality~     technologies and experiences of egocentric avatar embodiment in the application of physical~     and cognitive behavior therapy in functional neurological symptom/conversion disorder.~     Investigators hypothesize that patients will safely use and accept this modality of treatment~     and will show evidence of a decrease in symptom frequency.~   "
61201|NCT02765802|"~     Lambda is the pegylated form of interferon lambda-1a (IFN-λ), a conjugate of recombinant~     human interleukin 29 (rIL-29) and a linear polyethylene glycol (PEG) chain. IFN-λ and~     interferon alpha (IFN-α) share the common interferon (IFN)-stimulated gene induction pathway~     that leads to broad-spectrum antiviral activities. Since IFN-α has demonstrated~     anti-hepatitis delta virus (HDV) activity in patients with chronic hepatitis delta (CHD), it~     is postulated that pegylated IFN-λ could also induce HDV ribonucleic acid (RNA) decline in~     patients with CHD. Based on IFN-λ's more limited receptor distribution and previous data from~     studies involving treatment with IFN-λ in patients with hepatitis B virus (HBV) or hepatitis~     C virus (HCV), it is postulated that Lambda treatment could be associated with fewer adverse~     effects than IFN-α treatment. This Phase II study is designed as randomized, open-label study~     of Lambda 120 or 180 μg subcutaneous (SC) injection weekly for 48 weeks in patients with~     chronic HDV infection, and the primary objectives of the study are as follows:~        -  To evaluate the safety and tolerability of treatment with 2 dose levels of Lambda over a~          48-week treatment period.~        -  To evaluate the effect of treatment with 2 different doses of Lambda on HDV RNA levels.~   "
61202|NCT02765789|"~     Anti-glomerular basement membrane (GBM) glomerulonephritis is a rare autoimmune disease~     mediated by anti-GBM antibodies and characterized by acute renal failure due to diffuse~     crescentic glomerulonephritis. Established treatment is cyclophosphamide and corticosteroids~     to suppress anti-GBM production and daily plasma exchange to remove circulating anti-GBM~     antibodies. The vast majority of patients with anti-GBM glomerulonephritis develop~     irreversible end-stage renal failure despite this treatment. Immunoadsorption may lower~     anti-GBM titres more effectively than plasma exchange. The goal of this interventional open,~     non-randomized pilot study is to study the efficacy, adverse events, logistic feasibility and~     costs of immuno-adsorption for the removal of anti-GBM antibodies in patients with acute~     renal failure due to anti-GBM glomerulonephritis. Eight patients with acute renal failure due~     to anti-GBM glomerulonephritis with or without accompanying pulmonary involvement will be~     treated with daily immunoadsorption, instead of plasma exchange, until anti-GBM titres are~     undetectable. All other aspects of the treatment (e.g. immunosuppressive treatment, renal~     replacement therapy) will be standard. The primary study parameter is the number of days that~     anti-GBM antibody titre is above a toxic level, defined as >30 ELISA units. Secondary study~     parameters are the tolerability and adverse events of immunoadsorption, the logistic~     feasibility defined as the time interval between diagnosis and start of first~     immunoadsorption treatment and costs of immunoadsorption.~   "
61203|NCT02765776|"~     RAL is considered one of the better-tolerated antiretroviral medications, due to limited side~     effects and few long-term safety concerns. Five-year clinical trial outcomes and clinical~     experience have demonstrated durable virologic suppression in both treatment-naïve and~     treatment-experienced patients, including patients with extensive antiretroviral history and~     documented antiretroviral resistance. Studies have also exhibited low adverse effect rates~     and reliable long-term safety lending to improved tolerance. Several trials have evaluated~     the reduction in adverse effects in patients switched from various antiretroviral agents to~     RAL. Treatment-naïve studies have demonstrated a lipid-neutral effect in patients on~     RAL-containing regimens. When transitioning patients from a ritonavir-boosted PI regimen,~     statistically significant decreases in total plasma cholesterol, low-density lipoprotein, and~     triglycerides were demonstrated. Given its negligible interaction with the cytochrome P450~     system, RAL displays minimal drug-drug interactions, making it a good option for ageing~     patients on multiple medications.~      This is an observational retrospective cohort in real world to describe RAL data, including~     NUC-sparing regimens, in aged HIV patients. It is a phase IV study. 90 patients will be~     enrolled from the Department of Public Health and Infectious Diseases of Sapienza~     University of Rome. More than 4000 HIV patients are followed at this Department of Public~     Health and Infectious Diseases of Sapienza University of Rome. More than 50% of these~     patients are ≥ 50 years. From 10 to 12% are treated with a raltegravir based- regimen.~      The primary endpoint will be the description of the proportion of participants with an HIV-1~     viral load < 50 copies/mL.~      The secondary endpoints will be:~        -  Change from Baseline in CD4+ T-cell counts, CD8 cell counts, CD4/ CD8 ratio~        -  Proportion of subjects with laboratory alterations~        -  Proportion of patients with adverse events (AE), serious adverse events (SAE), also~          according to their severity~   "
61204|NCT02765763|"~     This is a placebo-controlled blinded clinical evaluation of day and night skin care creams~     supplemented by Medicell Technology's composition of defensins and supportive molecules~     determine the skin hydration and anti-aging properties of the topical test articles after~     repeated application to the skin of human subjects.~   "
61205|NCT02765750|"~     The patients scheduled for laparoscopic cholecystectomy will be allocated to 3 groups. Group~     A and B patients will listen to a positive message under general anesthesia. Group C patients~     will not listen to the message. The postoperative pain, analgesic consumption and frequency~     of nausea, vomiting and emergence agitation episodes will be documented and compared between~     the 3 groups.~   "
61206|NCT02765737|"~     Multicenter, prospective, randomized, controlled feasibility trial to determine the safety~     and effectiveness of Dehydrated Human Amnion Chorion Membrane (dHACM) plus Control as~     compared to Control alone for the treatment of second degree burns as assessed by time to~     healing and scarring~   "
61207|NCT02765724|"~     This is an open-label, parallel-group, single-dose study of the PK and safety of 400 mg~     pacritinib administered orally to patients with stable chronic liver disease and healthy~     control subjects.~   "
61208|NCT02765711|"~     This is a single-arm non-interventional cohort study. This study is to describe the~     contemporary use of ticagrelor in a real-world setting, to reflect its acceptance and~     patients' compliance, and to observe its one-year safety in patients with acute coronary~     syndrome in Fuwai Hospital.~   "
61209|NCT02765698|"~     The purpose of this study is to evaluate the ability of PET/MRI (Positron Emission~     Tomography/Magnetic Resonance Imaging) to give physicians preoperative information about~     specific sites in the body that the endometrial cancer may be present. If the PET/MRI is~     accurate and successful in providing this information, then women in the future may be able~     to have less extensive surgery for their endometrial cancer after evaluation with PET/MRI.~   "
61210|NCT02765685|"~     This is a biomedical study on a medical device. 120 patients will participate in this study~     and will be split into 2 groups:~        -  60 patients in the usual care group: these patients will receive the usual care~          proposed by their doctor for 12 months.~        -  60 patients in the ODRA group: these patients will wear the ODRA brace for 12 months~          in addition to their usual care. They will be instructed to wear the brace for at least~          6 hours per day, 5 days per week and to take it off during rest periods when lying down.~      The distribution of patients in the groups will be randomized. For this study, patients will~     be followed for 12 months, spread over 3 visits: inclusion visit, follow-up visit at 6 months~     and 12 months.~   "
61211|NCT02765672|"~     The main objective of this study is to discern if an Occupational Therapy Driving~     Intervention (OT-DI) improves fitness to drive abilities of Combat Veterans and also~     investigate if results leads to reduced driving errors on the driving simulator and an~     on-road test. The driving behavior of 260 Combat Veterans will be studied on a driving~     simulator at baseline after which they will be randomized into control and intervention~     groups. The intervention group will receive sessions of Occupational Therapy Driving~     Intervention by a trained driving rehabilitation specialist. The control group on the other~     hand will receive driving safety education sessions by a driving safety professional. Both~     groups will be evaluated for driving performance on the driving simulator to ascertain~     whether there have been changes in the number of driving errors at two and three months upon~     enrollment. Caregiver responses on driving behavior of Combat Veteran and public driving~     records from The Department of Motor Vehicles will be analyzed to for changes in number of~     driving errors.~   "
61212|NCT02765659|"~     This implementation study is testing whether community members can use a 3-step model~     (prepare, roll-out and sustain) to implement an efficacious peer group HIV prevention~     intervention with fidelity and effectiveness in a single district in Southern Malawi. A~     collaborative partnership including university researchers and district government, health~     system and traditional leaders will support community volunteers in implementation. Both the~     implementation process and the effectiveness of the intervention when implemented by~     communities will be evaluated.~   "
61213|NCT02765646|"~     The objective of this study is to demonstrate the clinical performance of the Tryton Side~     Branch Stent used in conjunction with a commercially available Drug Eluting Stent (DES) to~     treat de novo bifurcated lesions involving both the Left Main (LM) and Circumflex Coronary~     Artery(LCX).~   "
61214|NCT02765633|"~     The purpose of this study is to assess the PK/PD and safety profile of cangrelor in neonatal~     participants at risk of thrombosis.~   "
61215|NCT02765620|"~     Chemo-radiotherapy and targeted therapy are widely used as non-surgical treatments for solid~     tumors. Early assessment of treatment response is considered efficient and helpful to~     clinical management and personalized therapy.RECIST 1.1 criteria was accepted widely.~     Complete response (CR), partial response (PR), stable disease (SD), and progressive disease~     (PD) are defined in the RECIST criteria. This type of classification divides intrinsically~     continuous data (tumor size) into 4 bins, losing statistical power for ease of nomenclature~     and convenience. The 18F-FDG PET exam is based on metabolic information and considered to~     overcome limitations of anatomic imaging and more suitable for assessment of therapeutic~     response.PERCIST 1.0 proposes a series of detailed and unambiguous regulations about~     standardization procedures to ensure the reproducibility. Complete metabolic response (CMR),~     partial metabolic response (PMR), stable metabolic disease (SMD), and progressive metabolic~     disease (PMD) are defined in the PERCIST criteria.~      So far, there have several studies using metabolic-based PERCIST criteria in patients with~     solid tumors, including lung cancer, digestive tumor and lymphoma, etc. But all of these~     studies had limitations of small study sample, thus were need to be further investigated.~     Compared to RECIST, the advantages of PERCIST were to evaluate chemotherapy, especially~     targeted therapy, to distinguish PMR and SMD patients from SD group in RECIST, and to better~     predict the response rate. Recently, several studies applied PERCIST criteria to evaluate~     neoadjuvant chemotherapy in pancreatic cancer and rectal cancer, and revealed the metabolic~     response results were well related to pathology. All these studies conclude PERCIST criteria~     could help making clinical therapeutic decisions. Moreover, several studies have shown that~     PERCIST has advantage in predicting early response of several malignant tumors.~      The aim of this multicenter study is 1) to evaluate treatment response in newly diagnosed and~     pre-therapeutic patients with solid tumors who are going to receive a baseline , an early~     follow-up (after a certain period of treatment cycle) and a final (after treatment) 18F-FDG~     PET/CT; 2) to compared PERCIST criteria to RECIST 1.1 criteria in prediction treatment~     response, especially in early stage of treatment; 3) to reveal the value of PERCIST criteria~     in clinical therapeutic management and tailed therapy.~   "
61216|NCT02765607|"~     In this observational study investigators examine the presence of circulatory oscillations in~     blood pressure, heart rate, and doppler laser flow before and after planned cardiac surgery.~   "
61217|NCT02765594|"~     Immunoglobulin A nephropathy (IgAN) is the most common primary glomerulonephritis in the~     world.There is to date no curative therapy for patients with IgAN.It is considered that~     dendritic cells, Toll-like receptor (TLR) 9 and cytokines interleukin-6 (IL-6), and~     interferon-alpha (IFN-a) and tumor necrosis factor-alpha (TNF-α), play an important role in~     the aberrant mucosal response. Hydroxychloroquine is an antimalarial agent and had a notable~     impact on immune activation by the reduction of circulating activated immune cells that~     including decreased TLR-expressing cells, reduced IFN-secreting plasmacytoid dendritic cells,~     reduced production of inflammatory cytokines including interferon alpha, IL-6 and TNF alpha.~     Recent studies showed hydroxychloroquine had a benefit for renal remission and could retard~     the onset of renal damage in patients with lupus nephritis. hydroxychloroquine may have the~     potential effect in IgA nephropathy, alleviated the proteinuria and had the renal protect~     effect. This will be a single center, prospective, randomized, controlled study to assess the~     utility of hydroxychloroquine in IgAN patients.~   "
61218|NCT02765581|"~     The purpose of this study is to evaluate the efficacy of verum acupuncture (VA) for the~     prevention of migraine without aura compared to non-penetrating sham acupuncture (SA) and~     usual care alone (UC). This study also aims to determine whether the intensity of deqi~     sensations and psychosocial factors (including patient expectations, patient personality~     traits, patient-doctor relationship, traditional Chinese medicine constitution, depression,~     anxiety, sleep quality, etc.) are associated with clinical outcomes.~   "
61219|NCT02765568|"~     Coronary revascularization improves survival for patients with coronary artery disease.~     However,many patients are left with poor physical and mental health. Traditional cardiac~     rehabilitation involves moderate intensity continuous exercise (MICE). Alternatives to~     traditional cardiac rehabilitation programming may however provide superior understudied~     benefits to patients with poor physical and mental health. Nordic walking (NW) and~     high-intensity interval training (HIIT) are two examples of alternative programs for cardiac~     rehabilitation, which may provide superior physical and mental health benefits when compared~     to traditional MICE. The main purpose of this project is, therefore, to determine the short~     and long term physical and mental health benefits of alternative cardiac rehabilitation~     modalities, including NW and HIIT on exercise capacity, quality of life and depression after~     a 12-week program.~   "
61220|NCT02765555|"~     The purpose of this study is to assess the safety, tolerability and PK profile of a single~     dose of 60mg RBO-7000 in stable subjects with schizophrenia who are on medication other than~     risperidone.~   "
61221|NCT02765542|"~     The purpose of the study is to evaluate the feasibility and potential impact of an automated~     phone system in monitoring and improving self-care and health outcomes among patients with~     depression in Bolivia.~   "
61506|NCT02761824|"~     Implementation and Evaluation of an Activity Based Program to Improve Quality of Life~     Outcomes in Women Diagnosed With Cancer. Demonstrate improved life satisfaction (with~     evidenced gathered at three consecutive periods and geographical locations through Quality of~     Life surveys).~   "
61222|NCT02765529|"~     Nowadays, an increase of inflammatory chronic diseases and/or tumors incidence has been~     reported in part due to the rising in life expectancy. For instance, exposure to air~     pollution, and in particularly to fine particles has been classified by the International~     Agency for Research on Cancer (IARC) as a risk factor for cancer, being the elderly~     population particularly sensitive. However, no validated biomarkers have been identified to~     assess the exposure to fine particles maybe correlated to cancerogenesis.~      AEROTOX-2 is a prospective pilot study on the ex vivo effects of the atmospheric pollution~     exposure. The study aims to identity new biomarkers after an exposure of leukocytes to doses~     of fine particles.~      Secondly, the study aims to analyze, according to age, the leukocytes response to the urban~     pollution exposure.~   "
61223|NCT02765516|"~     The objective of this study is to utilize information on associations between genetic~     predisposition pertaining to multiple single nucleotide polymorphisms (SNPs) and the degree~     of responsiveness of low-density lipoprotein cholesterol (LDL-C) lowering to plant sterols~     (PS). The predictive potential of SNPs associated with PS responsiveness will be evaluated~     using a randomized human intervention trial examining responsiveness of lowering blood LDL-C~     levels to PS intervention.~   "
61224|NCT02765503|"~     The aim of the study is to test whether a resource-sparing 4-week, 20-fraction course of~     accelerated hypofractionated radiotherapy is non-inferior to accelerated radiotherapy~     delivering 33 fractions over 5.5 weeks in the treatment of patients with Stage I-IV squamous~     cell carcinoma of the pharynx, larynx and oral cavity with the exception of paranasal sinus,~     nasopharyngeal and stage I-II glottic carcinomas.~   "
61225|NCT02765490|"~     The purpose of this study is to evaluate the efficacy (proportion of subjects with SVR12),~     safety, tolerability and pharmacokinetics of an 8- and 6-week treatment regimen of AL-335,~     odalasvir (ODV) and simeprevir (SMV) in chronic HCV genotype 1, 2, 4, 5 or 6 infected~     subjects without cirrhosis.~   "
61226|NCT02765477|"~     The number of patients with cardiovascular implantable electronic devices (CIED), including~     ventricular pacemakers, continues to increase. However, there are no accurate~     electrocardiographic (ECG) criteria to diagnose acute myocardial infarction (AMI), even if~     due to acute coronary occlusion (ACO), with a ventricular pacemaker in situ. In this~     retrospective, multicenter, case-control study the investigators will examine ECG criteria to~     diagnose ACO in patients with ventricular paced rhythms. During this process, the~     investigators will also create a database from which investigators will be able to answer~     multiple additional questions on this population of patients.~   "
61227|NCT02765464|"~     Acute kidney injury (AKI) in critically ill trauma patients has been shown to significantly~     increase mortality, length of stay, and costs, however detection has proven difficult as~     markers like elevated creatinine and decreased urine output may take days to manifest and are~     late indicators of AKI. The combination of two urinary biomarkers, Tissue Inhibitor of~     Metalloproteinase 2 (TIMP-2) and Insulin-like Growth Factor Binding Protein 7 (IGFBP-7), has~     been shown to increase within 12 hours following renal insult, allowing assessment of risk~     for developing acute kidney injury. Therefore, the investigators plan to assess if acute~     kidney injury in critically ill trauma patients can be determined earlier using urinary~     TIMP-2 and IGFBP-7 via the NephroCheck testing system. These markers have not been~     specifically evaluated in trauma patients at risk of AKI.~   "
61228|NCT02765451|"~     This study evaluates the interventions of the Cancéropôle Nord-Ouest in the development of~     clinical research in non-academic health institution. The randomization, in open~     label,determines the duration of the interventions. Half of participants will receive the~     interventions during 2 years, while the other half during 1 year.~   "
61229|NCT02765438|"~     Balance disorders are sometimes treated with exercises performed on unbalanced surfaces. The~     BOBO system allows connection of a standing platform attached to any of these surfaces, to~     a screen, where the user can control games with his or her body movements. In this study, the~     lower limb muscle activity of healthy individuals will be monitored during different games in~     order to assert the the ability of each game in strengthening certain muscle groups.~   "
61230|NCT02765425|"~     The research objective of this study is to determine whether an intervention and associated~     robotic device called Assisted Movement with Enhanced Sensation (AMES) can be used to~     enhance balance recovery following an unexpected loss of balance by conditioning areas of the~     brain involved in lower-limb (LL) motor control. It is hypothesized that AMES can improve~     balance recovery, gait, and reduce falls in near-frail elderly people by improving LL~     strength, speed, and coordination.~      AMES, is a medical intervention and robotic device originally developed to aid patients'~     recovery from injuries to the central nervous system that limit movement. Earlier published~     studies demonstrated a unique property of AMES, namely that it is capable of reducing~     sensorimotor impairment in the severely impaired, an underserved population of patients with~     brain and spinal cord injuries. AMES applies assisted movement, biofeedback, and sensory~     stimulation simultaneously and non-invasively to the upper or lower limb, the initial intent~     being to address impairments such as weakness, spasticity, sensory loss, and dyssynergia~     (i.e., co-contraction). These reductions in impairment are achieved through cortical~     plasticity. In the present study, the same methodology will be applied to the lower limbs of~     the near-frail elderly to reduce falls by training faster reaction times, stronger reactions,~     and more coordinated recoveries from slips and trips~   "
61231|NCT02765412|"~     The overall goal of this project is to test two strategies for implementing a shared decision~     making tool to be used by providers while talking to patients about lung cancer screening.~     Eight participating sites will be randomized to compare standard implementation with~     intensive implementation. The investigators will also determine the effect of allowing~     providers to design their own risk threshold algorithms into a lung cancer screening decision~     aid, Decision Precision. Additionally, the investigators will determine the factors that were~     most important for successful implementation of the shared decision making tool. Finally, the~     investigators will survey patients to evaluate the effects of Decision Precision on patient's~     knowledge of the risks and benefits of lung cancer screening, the quality of their decision~     making, and their satisfaction with care.~   "
61232|NCT02765399|"~     This study aims to evaluate the mechanisms underlying the effect of incretin therapy on~     lipoprotein metabolism in subjects with type 2 diabetes and to study the effect of~     liraglutide on hepatic de novo lipogenesis.~   "
61233|NCT02765386|"~     When providing amplification post-implantation to residual acoustic hearing in the implanted~     ear, the lower frequency boundary can be modified to minimize or avoid overlap between the~     frequencies coded through acoustic hearing and those presented through electrical~     stimulation. This boundary is termed the cross-over frequency (Fc) and the effect of~     modifying this parameter will be investigated in this study. To avoid the research being~     confounded by prior bias for a particular frequency allocation, the study will be conducted~     with newly implanted recipients.~      This study will also investigate whether tests which measure the ability to use low frequency~     hearing and objective measures can predict the preferred Fc and speech performance benefit.~   "
61234|NCT02765373|"~     This study is a prospective, controlled phase IV clinical trial among postmenopausal patients~     with hormone receptor-positive breast cancer.The main purpose is to compare the effects of~     steroidal aromatase inhibitor (AI) exemestane and non-steroidal AIs on the lipid levels of~     breast cancer patients.~   "
61235|NCT02765360|"~     Patients with severe respiratory diseases such as chronic obstructive pulmonary disease~     (COPD) or obesity-hypoventilation syndrome (OHS) can benefit from having non-invasive~     ventilation (NIV). NIV consists of a machine (ventilator) that is blowing air inside a~     patient's airway through a mask. NIV provides patients with a bigger breath. Bigger breaths~     help patients to have a more oxygen and less waste gas (or carbon dioxide) in their body.~      These changes can improve outcomes and quality of life. In order to provide appropriate~     ventilation for each patient, the ventilator can generate different types of blowing:~        -  Continuous positive airway pressure (CPAP) which delivers a constant flow of air through~          the mask~        -  Pressure support ventilation (PSV) which delivers a constant flow of air through the~          mask and, on top of that, delivers more flow when the patient begins to inhale~        -  Volume targeted ventilation which delivers a flow of air through the mask that is~          adjusted breath by breath in order to achieve a preset volume.~      These different type of blowing have consequences on patient comfort as well as on the~     improvement of their ventilation.~      To assess the improvement of the ventilation, currently blood tests are used, however, these~     reflect overall output and may miss more subtle changes in breathing that could affect how~     patients feel.~      Electrical impedance tomography (EIT) is a new technology that involves wearing a belt of~     sensors around the chest that provides information on how well the lungs are being filled~     with air by the ventilator. It allows a non-invasive assessment of the effect of NIV on lung~     ventilation in real-time.~      The investigators hope to use the EIT technology to assess in real-time patients lung~     ventilation when they are using the NIV. The investigators hope that EIT will provide~     information on which type of blowing is more effective and more comfortable than the others.~   "
61236|NCT02765347|"~     The investigators intends to carry out a randomized, cross-over, prospective study which will~     last 48 weeks in youth with T1DM followed up by the center. The purpose is to observe the~     effects of metformin on glycemic control and insulin sensitivity in adolescents with T1DM~     based on insulin therapy by using 72h CGMS and hyperinsulinemic euglycemic clamps.~   "
61237|NCT02765334|"~     A feasibility trial of Neurostyle Brain Exercise Therapy Towards Enhanced Recovery (nBETTER)~     system for Brain Computer Interface (BCI) neurofeedback for rehabilitation of the subacute~     and chronic hemiplegic upper limb aimed at improving upper limb recovery for subacute to~     chronic stroke patients.~   "
61238|NCT02765321|"~     This is a population-based natural experiment study aimed to examine the effect of a~     multi-approach intervention focused on physical activity and healthy eating promotion to~     individuals living in Jaguariuna city (São Paulo, Brazil).~   "
61239|NCT02765308|"~     Uveitis is a disease that affects over 2 million people around the globe, and can ultimately~     lead to blindness. The proportion of patients with uveitis who become blind has not been~     reduced over the past 30 years, and this is therefore an area that demands further research.~     One of the major causes of blindness in uveitic patients is the development of uveitic~     glaucoma, which occurs in 10-20% of uveitic eyes. This is likely to occur for reasons related~     to the uveitis itself, but can also be caused as a side effect of the corticosteroids used to~     treat uveitis. The raised IOP in uveitis is more difficult to treat than other types of~     glaucoma.~      To enable more effective treatment of uveitic glaucoma, the investigators need to understand~     more clearly the mechanisms which underlie this process. The investigators therefore propose~     a study to examine the contribution of altered aqueous dynamics to the development of raised~     IOP in uveitis.~   "
61240|NCT02765295|"~     This is a multi-center, randomized, double-blind, parallel-group trial. After a 2-week run-in~     period, eligible patients will be, based on the randomization codes kept in sealed envelopes,~     randomly assigned to receive usual care (mucolytics and/or chest physiotherapy) plus oxygen~     inahaltion (1 hr daily for 12 consecutive months) or hydrogen inhalation (1 hr daily for 12~     consecutive months) provided by the sponsor. At 3 months after the end-of-treatment, a~     follow-up visit will be scheduled for all patients.~   "
61241|NCT02765282|"~     Participants will undergo DBS programming guided by the DBS-Expert system and by a clinician~     per standard care.~   "
61242|NCT02765269|"~     The purpose of this study is to determine whether the Intelligent Pain Management System~     (IPMS) could make recording and interfering pain timely among cancer patients with pain. The~     system's usability, feasibility, compliance, and satisfaction will also be assessed.~   "
61243|NCT02765256|"~     To determine the effect of a novel gut microbiota-targeted therapeutic regimen (bowel lavage~     and antibiotics with or without an antifungal) in the management of active Crohn's Disease~     (CD) that is refractory to conventional, immunosuppressive therapy.~   "
61244|NCT02765243|"~     Patients with refractory and/or recurrent neuroblastoma have poor prognosis despite complex~     multimodel therapy and therefore, novel approaches are urgently needed. The investigators are~     attempt to treat this disease using T cells genetically modified with a 4th generation~     lentiviral chimeric antigen receptor (CAR) targeting GD2 (4SCAR-GD2). The 4SCAR-GD2-modified~     T cells can recognize and kill neuroblastoma through the recognition of GD2, a surface~     protein expressed at high levels on neuroblastoma but not on normal tissues. This study will~     evaluate the side effects and effective doses of 4SCAR-GD2 T cells in treating refractory~     and/or recurrent neuroblastoma.~   "
61245|NCT02765230|"~     The purpose of this cross-sectional study is to compare bilateral anterior segment~     parameters, macular thickness, and BCVA at 3 months after uncomplicated unilateral pediatric~     cataract extraction with primary IOL implantation to explore any possible interocular~     differences and their possible relationships.~   "
61310|NCT02764372|"~     The aims of the present study were to:~        -  Investigate the feasibility of using a therapeutic gaming system (REHAB@HOME), based on~          Kinect, to augment upper extremity neurorehabilitation services.~        -  Provide preliminary evidence of clinical efficacy of the approach in increasing arm~          activity and health related quality of life of persons post stroke or with MS.~      Main results suggest that the serious games approach was positively received in terms of user~     experience and motivation to use, with the participants showing also improvements in~     functional abilities of the treated arm.~   "
61246|NCT02765217|"~     Recent studies showed that intestinal microbiota consist more than thousand bacteria, and~     these microorganisms play the role as balance and continuity of the anatomical and functional~     integrity gastrointestinal tract. Chronic diseases, nutritional factors, lifestyle factors~     and medications including antibiotics changes the host microbiota in short or long-term~     period. Antibiotics are the most commonly used drugs in pediatrics routine practice. Although~     frequency and severity of side effects alter the choice of drug, mild complications may be~     taken into consideration for treatment by a physician in the profit and loss balance. Our~     study group (PROBAGE Working Group) have been recently showed that Lactobacillus reuteri DSM~     17938 reduced the duration of diarrhea in children with acute infectious diarrhea, and are~     safe and well-tolerated. In this study the investigators aim to evaluate the potential effect~     of Lactobacillus reuteri DSM 17938 on the prevention of antibiotic associated diarrhea in~     children.~   "
61247|NCT02765204|"~     The purpose of this study is to evaluate if Dapagliflozin has direct effect on alpha cell~     glucagon release.~   "
61248|NCT02765191|"~     A study of renal blood flow and renal oxygenation measured by magnetic resonance after a~     standardized fluid challenge and blood pressure elevation in critically ill, resuscitated,~     septic patients.~   "
61249|NCT02765178|"~     Tourette syndrome is a complex neuropsychological disorder with both motor and vocal tics~     associated with multiple psychological co-morbidities. Apathy has not been widely studied in~     patients with Tourette syndrome. Apathy can result in decrease in self-care and disease~     control. In this study investigators will compare the occurrence of apathy in the adolescent~     Tourette syndrome population (at the UF center for movement disorders and Neurorestoration)~     to an age and gender matched control population. Investigators will also assess the role of~     commonly used medications in the Tourette population (neuroleptics and selective serotonin~     receptor inhibitors) in the occurrence of apathy.~   "
61250|NCT02765165|"~     This is a multicenter, open-label, Phase 1/2, dose-escalation and dose expansion study of a~     CXCR4 inhibitor, USL311, alone and in combination with lomustine in subjects with advanced~     solid tumors (Phase 1) and subjects with relapsed/recurrent GBM (Phase 2). The study is~     designed to explore the safety, tolerability, pharmacokinetics, and preliminary efficacy of~     USL311 alone and in combination with lomustine.~   "
61251|NCT02765152|"~     The purpose of this study is to verify the additional effects of rhythmic specific training,~     discrete specific training additional to conventional therapy on the upper limb after chronic~     stroke subjects on the outcomes: motor control and functionality.~   "
61252|NCT02765139|"~     The objective of the study is to evaluate the impact of Engaging Men in Accountable Practice~     (EMAP) on the prevention of violence against women and girls in North and South Kivu (DRC).~     The study is conducted jointly by the World Bank's Africa Gender Innovation Lab and the~     International Rescue Committee (IRC). EMAP is a program developed and implemented by the IRC~     to engage men to reflect on how to reduce and prevent intimate partner violence through 16~     weekly group discussion sessions. The study is a cluster randomized control trial in which~     two groups of 25 self-selected men in 15 communities receive the EMAP intervention while in~     15 other communities, 50 self-selected men receive an alternative intervention. Key outcomes~     examined include: (i) Experience of past year physical, sexual and psychological violence~     reported by women whose partners are EMAP participants; (ii) Participant's gender attitudes~     and behaviors, conflict and hostility management skills; (iii) Power sharing and~     communication within the couple.~   "
61253|NCT02765126|"~     Vaccines can have non-targeted or heterologous (also called non-specific) immunological~     effects on the immune system i.e. effects other than inducing an immune response against the~     disease targeted by the vaccine. This trial aims to evaluate the non-specific immunological~     effects of two vaccines - diphtheria-tetanus-acellular pertussis (DTP) vaccine and seasonal~     influenza vaccine - in a cohort of elderly humans (>65 years of age) and healthy adult~     control subjects (30-50 years).~   "
61254|NCT02765113|"~     1. Background: Blepharospasm refers to orbital and periorbital orbicularis muscle~          spontaneous spasmodic contraction. Continuous spasm can be long or short, the~          performance of non spasm will strongly closed repeatedly. At present, the pathogenesis~          of blepharospasm is not clear, in addition, there is no particularly effective~          treatment.~        2. Purpose：compare two different surgical methods, observe the improvement of symptoms and~          prognosis of patients with blepharospasm.~        3. Scientific hypothesis: At present, the pathogenesis of blepharospasm is not clear, but~          clinical patients with blepharospasm showed bilateral eyelid twitching, eyes open~          difficulties and the symptoms are worse when tension, anxiety, insomnia, light~          stimulation and wind outside stimulation. At the same time, in the clinic，the~          investigators found that facial nerve and trigeminal nerve combing can improve the~          clinical symptoms of the patients. Therefore, the investigators speculated that over~          activity were related to clinical symptoms and corneal reflex pathway of blepharospasm~          patients.~        4. Research content: the blepharospasm patients were randomly divided into two groups,~          prospective comparative analysis of two different surgical methods for the treatment of~          blepharospasm. One group of patients were performed facial nerve combing and~          microvascular decompression, the other group of patients were performed facial nerve,~          trigeminal nerve combing with microvascular decompression, to observation of~          postoperative clinical improvement of two groups of patients.~        5. Expected results:To define a surgical method for the treatment of blepharospasm, and to~          promote the use of the academic and clinical practice.~   "
61255|NCT02765100|"~     The purpose of this study is to better understand the relationship between bipolar disorder,~     body weight, and inflammation in the body. People with bipolar depression will be offered a~     place in a pilot study looking to see if the antibiotic minocycline added to current~     psychiatric medications has an effect on mood. A separate consent form will be provided for~     the pilot study. Numerous studies have documented the presence of altered immune function and~     elevation of inflammatory markers in patients with depression. Studies suggest that major~     depression is accompanied by immune dysregulation and activation of the inflammatory response~     system. While a small number of studies have found elevated inflammatory markers in bipolar~     mania, very little has been reported about inflammation in bipolar depression, and none of~     these studies have addressed the relationship of inflammatory markers with obesity in bipolar~     disorder.~   "
61257|NCT02765074|"~     Rheumatoid arthritis (RA) is a chronic inflammatory disease mediated by the production of~     several cytokines, which leads to the destruction of bone and cartilage tissue in multiple~     joints and to bone loss. Conventional radiographs (CR) are considered as the gold standard~     for diagnosis and follow up of joint changes in RA. But this method has low sensitivity to~     detect early erosive changes and is unable to evaluate periarticular bone loss.~      High Resolution peripheral QCT (HRpQCT) enables the detection of erosions less than 0.5 mm in~     width or depth at metacarpo-phalangeal (MCP) joints. Using 3-D high resolution analysis of~     cortical bone erosions, this one is also able to evaluate the volumes of erosion and the~     evolution under treatments IL6 (6- interleukin) plays a major role in inflammatory process~     and bone damages related to RA. Tocilizumab (TCZ) is a humanized anti-IL-6R monoclonal~     antibody, developed and investigated in several clinical trials in RA. This biotherapy, in~     association with methotrexate (MTX) or given in monotherapy, is efficient in RA with~     inadequate response to MTX or anti-TNF b (tumor necrosis factor). TCZ reduces dramatically~     systemic inflammation, structural progression and improves clinical symptoms and quality of~     life.~      Tocilizumab may help reducing bone erosions, periarticular osteopenia and systemic bone loss.~   "
61258|NCT02765061|"~     Coronary artery disease is a common medical disease in many populations. The pathogenesis of~     this disease is very complex. Surgery is one of the treatment choices. Assessing the risk~     factors will improve the surgical outcome. In this study some biochemical parameters were~     evaluated to find out the relationship between these parameters (electrolytes and albumin vs)~   "
61259|NCT02765048|"~     The purpose of the study is to adapt and test an evidence-based trauma treatment program for~     adolescent girls with histories of child maltreatment. The study adapts the CBITS (Cognitive~     Behavioral Intervention for Trauma in Schools) program for delivery within community-based~     settings for use with girls assessed and/or served by the child welfare system. The study~     utilizes a randomized clinical trial that evaluates the effectiveness of the adapted program~     entitled GAIN (Girls Aspiring toward Independence) compared with a usual care group. Primary~     outcomes of the intervention are mental health symptoms such as PTSD, depression, and~     internalizing and externalizing behaviors. Other outcomes include aggressive behaviors,~     revictimization, and aggression-related beliefs, self-efficacy, and behavioral intentions.~   "
61260|NCT02765035|"~     The aim of this post-market study is to confirm that the microprocessor controlled prosthetic~     knee components (C-Leg 3 and C-Leg 4) in comparison to mechanical knee joints can bring~     additional benefit to the users primarily on level walking and secondarily in safety, stair~     and hill mobility, activities of daily living, satisfaction and preference.~   "
61261|NCT02765022|"~     An simple-blind, randomized study, to evaluate the efficacy and safety of complete closure~     with clips of mucosal defects after endoscopic mucosal resection (EMR) of large~     non-pedunculated colorectal lesions (≥ 2 cm) as prophylaxis of delayed bleeding.~   "
61262|NCT02765009|"~     Most ICU patients develop a positive fluid balance, mainly during the two first weeks of~     their stay. The causes are multifactorial: a reduced urine output subsequent to shock state,~     positive pressure mechanical ventilation, acute renal failure, post-operative period of major~     surgical procedures, and simultaneous fluid loading to maintain volemia and acceptable~     arterial pressure. Additionally, the efficacy of fluid loading is frequently suboptimal, in~     relation to severe hypoalbuminemia and inflammatory capillary leakage. This results usually~     in a cumulated positive fluid balance of more than 10 litres at the end of the first week of~     stay. A high number of studies have showed that such a positive fluid balance was an~     independent factor of worse prognosis in selected populations of ICU patients: acute renal~     failure, acute respiratory distress syndrome (ARDS), sepsis, post-operative of high risk~     surgery. However, little is known about the putative causal role of positive fluid balance by~     itself on outcome. However, in two randomized controlled studies in patients with ARDS, a~     strategy of fluid balance control has been demonstrated to reduce time under mechanical~     ventilation and ICU length of stay with no noticeable adverse effects. Although avoiding~     fluid overload is now recommended in ARDS management, there is no evidence that this approach~     would be beneficial in a more general population of ICU patients (i.e. with sepsis, acute~     renal failure, mechanical ventilation). In addition, fluid restriction -mainly if applied~     early could be deleterious in reducing both tissue oxygen delivery and perfusion pressure.~     There is a place for a prospective study comparing a conventional attitude based on liberal~     fluid management throughout the ICU stay with a restrictive approach aiming at controlling~     fluid balance, at least as soon as the patient circulatory status is stabilized. The latter~     approach would use a simple algorithm using fluid restriction and diuretics based on daily~     weighing, a common procedure in the ICU, probably more reliable than cumulative measurement~     of fluid movements in patients whose limits have been underlined.~   "
61263|NCT02764996|"~     This will be an exploratory observational trial of rescue acupuncture for the treatment of~     acute migraine in military beneficiaries to gain information to inform the power analysis of~     a larger, more definitive trial. Researchers do not seek to definitively answer the question~     of whether this acupuncture protocol is effective; rather, we seek to estimate the proportion~     of migraine episodes that result in headache-free status 20-30 minutes, 2 hours, 4 hours, and~     24 hours after an acupuncture treatment. Acupuncture treatments will be subject dependent,~     and points could include the N point (on scalp); various auricular points to include Shen~     Men, Point Zero, thalamus and Omega-2; body points to include Liver 2, Liver 3, Gall Bladder~     20, bladder 10; and surface release over tense areas in the neck or shoulders. Researchers~     will document the points used, and data will be aggregated to determine overall~     effectiveness. Sub-group analysis by points will be performed to determine if there is more~     usefulness in 1 point or combination of points. These estimates will inform statistical power~     calculations for a future randomized controlled trial (RCT) that directly compares the~     effectiveness of Rescue Acupuncture with medical management of acute migraine with rescue~     medication. Researchers will also assess the feasibility of this study protocol as well as~     patient receptivity and satisfaction.~   "
61286|NCT02764697|"~     Uveitis represents a heterogeneous group of diseases that results from ocular inflammatory~     reaction involving ocular tissue and vasculature. The inflammation usually causes pain,~     redness, photophobia and blurred vision. This inflammation, is typically treated with~     regional or systemic therapy. The regional therapy typically consists of topical~     corticosteroids or periocular or regional corticosteroids. Regional therapy can lead to a~     steroid response glaucoma, which is increased intraocular pressure.This pilot study aims to~     evaluate the possible effectiveness of H.P. Acthar in patients with active ocular~     inflammatory disease, and currently on treatment for glaucoma or have a history of glaucoma.~   "
61490|NCT02762032|"~     This study will demonstrate the ability of the oral supplement, PrimaVie® to improve skin~     microperfusion, hydration, elasticity and barrier function. 45 females will be enrolled in 1~     of 3 arms where they will receive either 125 mg PrimaVie, 250 mg PrimaVie or placebo~     (control) to take twice daily for 14 weeks.~   "
61264|NCT02764983|"~     Driving is a portal into general life functioning, and impaired driving skill can pose a~     serious threat to the combat veterans (CV), passengers and others; and involves increased~     risk of subsequent injuries, medical expenses and legal sequelae. Motor vehicle crashes (MVC)~     among post deployed CV are one of the top four causes of injury and disability,~     hospitalization, and outpatient visits across the military, and are a leading cause of death~     among Army service members. The risk of motor vehicle (MV) death is significantly increased~     in years immediately following return from the battlefield. In sum, the effects of Traumatic~     Brain Injury (TBI)/ Post Traumatic Stress Disorder (PTSD) and other blast related injuries,~     combined with the battlefield mindset and lack of community reintegration programs place CV~     at risk for MVC and fatalities. On-road assessments, the gold standard, presents a risk for~     crash or adverse advents in this population of CV. Alternately, simulated driving evaluation~     measures driving performance in a safe, accurate and objective manner with evidence of~     absolute and relative validity when compared to real world (on-road) driving. Knowing~     participants can or cannot safely resume driving, and providing rehabilitation for those with~     a potential for resuming safe driving could result in: increased safe driving behaviors;~     avoidance of injuries, collisions, citations and participants residua; and resuming safe~     driving with its attendant benefits in the realms of family functioning, participation in~     society and satisfaction with life. The overarching objective of this proposal is to discern,~     after clinical and simulated driving performance testing , if Occupational Therapy Driving~     Intervention (OT-DI) can improve the safe driving performance (less errors) over the short~     term (immediately following intervention) and intermediate term (3 months).~   "
61265|NCT02764970|"~     Out-patients scheduled for coronary computer tomographic angiography (CCTA) were screened~     regarding their baseline heart rate. If heart rate was > 75, patients were pretreated with~     10mg bisoprolol (group 1) or 10mg bisoprolol plus 7.5mg ivabradine (group 2) to reduce heart~     rate one our before CCTA was performed.~      Heart rate, additional use of i.v. bradycardic agents, motion artefacts, radiation dose and~     drug tolerance was monitored.~   "
61266|NCT02764957|"~     Metabolic syndrome (Mets) is an assemblage of risk factors which can increase the risk of~     developing type 2 diabetes mellitus and cardiovascular disease. Green coffee extract (GCE) is~     derived from unroasted coffee beans and has substantial amounts of polyphenols primarily~     chlorogenic acids (CGA). It has been shown that GCE and CGA can exert a positive influence~     over Mets components including blood pressure, blood glucose, inflammation, oxidative stress,~     insulin resistance and blood lipids. Up to our knowledge no study has been conducted on~     humans in the field of GCA influences on Mets patients. Therefore, this study is planned to~     evaluate GCA supplementation effects on anthropometric measurements, glycemic control, blood~     pressure, lipid profile in patients with metabolic syndrome.~   "
61267|NCT02764944|"~     This study evaluates the feasibility of endo-laparoscopic full-thickness resection with~     simple suturing technique which did not expose gastric mucosa to peritoneum (simple~     non-exposure EFTR) in patients with gastric tumor.~   "
61268|NCT02764931|"~     The research aims to investigate the effects of gluten-free oats to the gastrointestinal~     health in celiac disease patients and healthy subjects. The effects of gluten-free oats on~     the several intestinal parameters, on the composition of the gut microbiota as well as on the~     metabolic profile of celiac patients and healthy controls will be studied. The study is~     divided into two parts.~      Part 1 will be conducted as a double-blind, randomized and placebo-controlled cross-over~     study. Healthy subjects will be recruited to the study. The aim is to recruit 15 participants~     for the part 1. The study will be conducted with a cross-over setting, where the subjects~     will go through exposure meals and SmartPill ingestion three times (two different oat~     products and placebo) in a randomized order. The study meals are identical in appearance and~     fiber content. After consuming the meal subjects will ingest the SmartPill capsule, which~     will send data on intestinal pH, pressure and temperature to the external portable device.~     Before and during the passage of capsule the subjects will fill a symptom and food diary. The~     capsule will exit the body in 1 to 3 days and the data collected by the external device will~     be collected and analyzed. Before the oat/placebo exposure the subjects will give a fecal and~     a blood sample. In addition, 36 hours urine samples will be collected.~      In part 2 celiac disease patients, non-celiac gluten sensitive subjects and healthy controls~     will be recruited and they will be divided into four groups: oat-avoiding celiacs (1),~     oat-consuming celiacs (2), non-celiac gluten sensitive subjects (3) and healthy controls (4).~     Recruiting aim for each group is 15 subjects. In addition to dietary data, a blood, and a~     fecal sample will be collected from the subjects. The gut microbiota will be analyzed from~     the fecal samples. The metabolic products will be analyzed from the fecal, urine and blood~     samples. The gut microbiota composition will be analyzed with next-generation DNA sequencing~     techniques.~   "
61269|NCT02764918|"~     The purpose of this study is to investigate the incidence of Cryptosporidiosis in Bangladeshi~     children and describe the acquired immune response to the pathogen as well investigate the~     potential of human genetic susceptibility.~   "
61270|NCT02764905|"~     This will be a feasibility study. Individuals that have undergone an evaluation day at the~     center for successful aging with diabetes with a Glycosylated hemoglobin (A1C) of >=7.5 and a~     Montreal Cognitive Assessment (MoCA)<26 will be approached and invited to participate. The~     participants will be divided into 2 groups: 1) information communication technology (ICT)~     group - an intervention based on weekly SMS that will remind the individual to implement his~     personal treatment plan and will raise the awareness to the importance of self-care in~     diabetes; 2) intensive cognitive-physical rehabilitation group that will include a 2 phase~     multi-disciplinary intervention. The 2 phases: a) Intensive phase: weekly 4 hour group~     meeting which will include computerized cognitive training, aerobic, balance and strength~     exercise and group discussion that will be dedicated to cognitive rehabilitation strategies~     development and implementation with emphasis on disease management and physical activity as~     well as psycho-education on various disease management aspects (medical and nutritional) b) a~     consolidation phase: monthly 2 hour group discussions on challenges of implementation and~     coping strategies. Outcomes will include change in A1C (primary), change in strength, aerobic~     capacity as well as quality of life and cognitive function (secondary). Additionally, team~     members and participants will fill out a structured questionnaire regarding their evaluation~     of the program aiming at refinement of the intervention.~   "
61271|NCT02764892|"~     The main purpose of the study is to identify the best dose of V81444 to use in future trials~     in patients with Parkinson's disease. The study will also explore the effects of V81444 on~     brain activity and blood flow with tests of mental ability (cognitive function tests). It~     will also check how safe V81444 is and how well it is tolerated after dosing.~   "
61272|NCT02764879|"~     The study was aimed to investigating changes in periodontal parameters and superoxide~     dismutase activity after root surface debridement with and without Omega 3 fatty acids (ω-3~     FAs) supplementation in postmenopausal women. Adjunctive Omega 3 fatty acids supplements~     reduce periodontal inflammation and improve the status of systemic enzymatic antioxidants in~     postmenopausal women.~   "
61273|NCT02764866|"~     The study seeks to determine the prevalence of sleep disordered breathing in a population of~     patients diagnosed with lung cáncer.~   "
61274|NCT02764853|"~     Striving Towards Empowerment and Medication Adherence (STEP-AD) is a research study aimed at~     developing an intervention for Black women living with HIV to address psychosocial factors~     (i.e. abuse/trauma histories, racial discrimination, HIV stigma/discrimination, and~     prescribed traditional gender roles) that have been associated with medication nonadherence~     or poor HIV outcomes (e.g. viral load, CD4), but are unaddressed in existing interventions.~   "
61275|NCT02764840|"~     Resistance exercises from elastic tube has been used as part of the rehabilitation and~     maintenance of muscle tone levels in different scenarios, from disease conditions to the~     sports universe. There is the convenience and low cost of the instrument, which can provide~     impact on clinical and economic framework in case of spillage of use strategies. In a recent~     search, the investigators were not observed data on the reliability and reproducibility of a~     specific test for this tool and in this sense, it seems pertinent to undertake research on~     the topic. Objectives: To determine the reliability and reproducibility by comparison with a~     isokinetic muscle strength test located â fatigue held in elastic tube and compare the~     results of a training protocol for muscle strength gain in both methods, elastic tube and~     dynamometer. Methods: Participants will perform the muscular endurance test localized~     fatigue, on two occasions, with an interval of seven days between them. Everyone will~     accomplish so much in the elastic tube, as in the isokinetic dynamometer. It will be held~     evaluator analysis intra and inter evaluator. After first stage of the study to determine the~     reliability test, the participants will undergo three weeks of training to gain muscular~     endurance, distributed in two groups G1 (training in the elastic tube) and G2 (training in~     isokinetic dynamometer) previously randomized. It will use the intra-class correlation~     coefficient with 95% confidence interval to check the repeatability and the Kappa coefficient~     with 95% confidence interval for reproducibility. To compare the responses of training, the~     distribution will be made as to the normality of the data by the Kolmogorov-Smirnov test. In~     the case of normal distribution, the Student's t-test for unpaired data and Mann-Whitney will~     be adopted if there is no normal distribution.~   "
61276|NCT02764827|"~     Pollen allergen extracts are prepared locally and checked for efficacy by comparison to~     imported allergens and specific IgE.~   "
61277|NCT02764814|"~     Prospective controlled pilot study to compare the outcome of ProKera® (PK) and conventional~     treatment in patients with moderate to severe Dry Eye Disease (DED)~   "
61278|NCT02764801|"~     The primary objective of this trial is to evaluate the sensitivity and specificity of 2D and~     4D contrast enhanced ultrasound for monitoring transarterial chemoembolization (TACE)~     response 1-2 weeks and 1 month post treatment as an alternative to contrast-enhanced magnetic~     resonance (MRI) or computed tomography (CT) imaging~   "
61279|NCT02764788|"~     Fibromyalgia (FM) is the most common cause of diffuse pain in the bones and joints, and one~     of the most frequent causes of referral to the pain management unit. It affects mainly women;~     they are referred by a rheumatologist, an internal medicine physician or by their family~     physician.~      FM produces various degrees of disability and pain, and has an important impact on quality of~     life. Sleep disorders, fatigue and cognitive dysfunctions are almost always part of the~     clinical presentation. The wide range of symptoms and signs, the unknown etiology, the lack~     of efficacy of pharmacological treatments make management of FM a very difficult task. In~     France the consensus includes limitation of pharmacological treatment, encouraging physical~     rehabilitation and referring the patients to a specialized pain clinic where~     multidisciplinary management will be undertaken. In our hospital the investigators favor non~     pharmacological therapies and propose to the FM patients to learn relaxation and~     self-hypnosis, physical rehabilitation and use of trans cutaneous electrical~     neurostimulation.~      Auriculotherapy (AT) is a complementary therapy, based on the idea that the ear is a~     microsystem which reflects the entire body, represented on the auricle, the outer portion of~     the ear. Mapping of the auricle has been described, according to the fact that pathology of~     different organs can induce specific changes in the auricle, for example color change or~     sensitivity. Treating specific areas, which somehow would be connected to the affected~     organ could also improve the functioning of the body or relieve pain. AT uses placement of~     needles at points tailored to the patient's pathology. Whatever the mechanisms involved, the~     effectiveness of ATis currently supported by randomized controlled trials. It is validated by~     WHO since 1987, mapped in an international nomenclature initially proposed by Nogier.~      The investigators regularly use AT in FM patients in our pain management unit to alleviate~     symptoms as pain, sleep disorders, anxiety. The investigators established a clinical trial in~     this population to assess impact of FM (assessed with Fibromyalgia Impact Questionnaire)~     following 3 months of AT management (Primary Outcome). Sleep disorder, fatigue, anxiety and~     depression, cognitive and physical dysfunction are also evaluated as secondary outcomes. The~     remnant effect of AT is also evaluated, 3 month after the end of the treatment by the same~     tests.~   "
61280|NCT02764775|"~     Inclusion Criteria: children ages 2 to 14 years with poor head control and non progressive~     diagnoses. Exclusion criteria: significant change of status i.e. prolonged hospitalization,~     surgery; inability to tolerate using Headpod. Requires use of Headpod 3x per day for minimum~     of 15 minutes each time over a 6 month period. Log must be kept documenting usage of the~     Headpod. Video will be taken to document changes.~   "
61281|NCT02764762|"~     The purpose of this study is to determine the effect of triple combination therapy with an~     anti-integrin [vedolizumab intravenous (IV)], a tumor necrosis factor (TNF) antagonist~     [adalimumab subcutaneously (SC)], and an immunomodulator (oral methotrexate) on endoscopic~     remission in participants with newly-diagnosed Crohn's disease stratified at higher risk for~     complications.~   "
61282|NCT02764749|"~     Epidemiological studies suggest that the consumption of (poly)phenols rich foods such as~     cocoa, tea, fruits and vegetables is associated with lower blood pressure, reduced~     cholesterol and decreased cardiovascular risk. Cranberries are a rich source of~     (poly)phenols, including anthocyanins, proanthocyanidins and phenolic acids. Whether~     cranberries can improve vascular function when given over relevant time periods and in~     relevant populations is not known. Therefore, it is the overall hypothesis of the study~     proposal that chronic consumption of cranberries can improve endothelial function, a~     prognostically validated surrogate of cardiovascular risk. This study also aims to reveal~     which cranberry (poly)phenols have bioactive properties in healthy men. Consequently, plasma~     and urine metabolite peaks will be correlated with vascular outcomes and genome-wide~     expression microarrays will be performed to reveal cell signaling pathways associated with~     cranberry (poly)phenol-mediated cardioprotective events.~   "
61283|NCT02764736|"~     The specific aim of this trial is to determine whether initiating moderate- or high-intensity~     atorvastatin therapy in hemodialysis patient not previously on a statin reduces inflammation~     and lowers average Epogen utilization. Statin naive patients on maintenance HD will be~     started on 20mg atorvastatin daily for weeks and then titrated up to 40mg atorvastatin daily~     for an additional 12 weeks. Patient's inflammatory markers (ferritin, CRP) and weekly Epogen~     usage will be monitored.~   "
61284|NCT02764723|"~     The purpose of this study is to evaluate the efficacy and safety of spinal anesthesia with~     isobaric ropivacaine, compared with hyperbaric bupivacaine in geriatric patients undergoing~     lower limb orthopedic surgery.~   "
61285|NCT02764710|"~     The optimal use of prophylactic antibiotic therapy to prevent infection after sinus lift and~     augmentation surgery is unknown. This is a comparative open label interventional trial~     comparing a standard 7-day course of postoperative treatment with amoxicillin-clavulanate~     with short antibiotic treatment for up to 24 hours postoperatively. The primary study outcome~     is the postoperative surgical site infection in the standard versus the short treatment arms.~     Secondary outcomes are drug-related adverse events and Clostridium difficile infection.~   "
61301|NCT02764489|"~     The purpose of this study is to:~        -  1. To evaluate the tolerability and safety of infusing reduced volume Factor Eight~          Inhibitor Bypassing Activity (FEIBA) at the standard infusion rate of 2 U/kg/min~        -  2. To evaluate the tolerability and safety of infusing reduced volume FEIBA at increased~          rates of 4 and 10 U/kg/min, in comparison to the standard rate of 2 U/kg/min at the~          regular volume~   "
61287|NCT02764684|"~     Objective:~      In this study the investigators aim at investigating:~        1. probiotics ability to modulate the microbiome and microbial translocation,~        2. if probiotics affect the level of cholesterol, triglycerides as markers of~          cardiovascular risk factors and~        3. if a reduction of microbial translocation is associated with a reduction of inflammation~          in the gastro-intestinal tract.~      Design:~      The study is a prospective clinical intervention trial of 40 HIV-infected patients.~      Method:~      The investigator will administer the bacteria Lactobacillus Rhamnosus in capsular form to~     each patient 2 times a day in 8 weeks. At baseline and at the 8th week of the intervention,~     the investigators will collect blood samples, feces samples and make a positron emission~     tomography-magnetic resonance scans.~   "
61288|NCT02764671|"~     The purpose of this study is to further evaluate the immunogenicity and safety of 10μg/0.5ml~     Recombinant Hepatitis B Vaccines(Saccharomyces Cerevisiae) in the Healthy Neonates.~   "
61289|NCT02764658|"~     The investigators previous research has demonstrated that proteoglycan 4 (PRG4) may be a~     biomarker for identification of severity in COPD. PRG4 was more sensitive and specific than~     CRP for confirming COPD severity and acute exacerbation frequency. It was related to the~     1-year force vital capacity decline in COPD patients. The past study found that Prg4 is an~     immunomodulatory factor regulating parathyroid hormone actions on hematopoietic cells in~     mice. Previous report showed that voluntary wheel running and fluid flow shear stress that~     promote the expression of the Prg4 and association with pulmonary inflammation. COPD patients~     are characterized by a progressive decrease of lung function that is associated with~     increased in the airway and systemic inflammation. Pulmonary recovery (PR) is able to~     decrease acute exacerbation, maintain pulmonary function, increase exercise tolerance and~     improve quality of life in COPD patients, but it is unknown the mechanism of PRG4. The~     current study aimed to study in the pulmonary inflammation and the effectiveness of pulmonary~     recovery in COPD Patients：The mechanism of PRG 4.~   "
61290|NCT02764645|"~     This is a single center, prospective study:~      The 'CardioGard Cannula' Gaseous emboli capture results - shows an improvement from the~     control group.~   "
61291|NCT02764632|"~     Insertion of a nasogastric tube (NGT) in anesthetized patients can be a disappointing~     experience. Many techniques have been explained to improve success rate along with increasing~     safety, such as forward displacement of the larynx, tube rigidity improvement methods,~     pushing it down directly through pharynx or using a guide tube. Failure of insertion under~     general anesthesia reached 50% in some publications~   "
61292|NCT02764619|"~     A randomized, double-blinded, placebo-controlled study to evaluate the effect of~     spironolactone in addition to conventional treatment compared with placebo in patients with~     paroxysmal and persistent atrial fibrillation with preserved left ventricular ejection~     fraction by T1 mapping, structure and function of left atrium and ventricle assessed by~     transthoracic echocardiography and cardiac magnetic resonance (CMR), the number of recurrent~     episodes of atrial fibrillation and biomarkers measured in blood.~   "
61293|NCT02764606|"~     CANPOS is a non-interventional study aiming at evaluate at the time of initial surgery the~     value of new serum markers to predict the occurrence of metastases in patients with~     early-stage non-small cell lung cancer. This would represent a rational to develop~     personalized follow-up and prevention strategies~   "
61294|NCT02764593|"~     This study will evaluate the safety of adding nivolumab to several chemotherapy platforms~     with weekly cisplatin, high-dose cisplatin, cetuximab or radiation therapy alone.~   "
61295|NCT02764567|"~     Lab sampling for clinical trial participants can be a stressful and painful experience. Most~     trial participants will have blood drawn for lab samples at multiple study visits. The~     participants must fast for up to ten hours before the blood sampling, in many cases, and~     patients often report a painful experience if more than one venipuncture occurs. In addition,~     the number of collection tubes can increase the anxiety level of the patient and the~     phlebotomist.~      This project proposes to evaluate if essential oil aromatherapy results in less pain and /or~     anxiety when compared to usual care.~   "
61296|NCT02764554|"~     The purpose of this post-marketing surveillance (PMS) is to observe the safety profile of~     Lenvima (lenvatinib) in normal clinical practice setting.~   "
61297|NCT02764541|"~     This research study is evaluating how well Breast Cancer responds to preoperative treatment~     with Endocrine treatment in combination with a drug called Palbociclib or Endocrine treatment~     alone as possible treatments for Hormone Receptor Positive Breast Cancer.~   "
61298|NCT02764528|"~     The purpose of the handwashing intervention trial is to determine whether an interactive,~     storytelling approach to promoting handwashing with soap by health care workers can improve~     mothers' handwashing behavior during the first month of her child's life.~   "
61299|NCT02764515|"~     This is a multicenter, randomized, double blind, double-dummy and controlled clinical trial~     aimed to compare the clinical efficacy and safety of Kunxian Capsule, a compound of Chinese~     traditional medicine, and the active comparator,Methotrexate for the treatment of rheumatoid~     arthritis. The primary end-point is that Kunxian Capsule is not inferior to Methotrexate both~     in efficacy and safety.~   "
61300|NCT02764502|"~     Introduction Several attempts have been made to improve or facilitate epidural space~     detection beside conventional loss of resistant technique. Recently many sophisticated~     equipment's and techniques have been described which did not received widespread popularity.~      Objectives The Investigator describes and assesses the validity of using Pressure Gauge~     Manometer to confirm correct detection of lumber epidural space, in an inexpensive way.~      Methods Tuohy needle is introduced into intervertebral space at the level of L3-L4 up to the~     interspinous ligaments ( nearly 2cm mark on the needle).A3-way stopcock is connected to the~     hub of Tuohy needle with the in-line port of the stopcock attached to an air-filled 10 ml~     syringe. Using a 75 cm extension tube set and create a 30 mm Hg pressure gradient between~     manometer and the tip of epidural needle , the needle is advanced slowly using both hands~     while monitoring the manometer reading and is stopped when the pressure suddenly dropped (~     the pressure usually drops by 5-10 mm Hg when the tip of the needle inters the epidural space~     ).~   "
61507|NCT02761811|"~     To evaluate the safety and efficacy of targeted renal sympathetic denervation using SyMapCath~     I™ in patients with pharmacotherapy and uncontrolled hypertension for at least 6 months, then~     after standardized antihypertensive drug therapy (at least two drugs) for at least 28 days,~     office systolic blood pressure (BP) is still ≥ 150mmHg, ≤180mmHg.~   "
61303|NCT02764463|"~     This prospective clinical study evaluated the performance of indirect, posterior~     occlusal-retained, fiber-reinforced-composite restorations.~      Methods: Between June 1999 and June 2000, a total of 58 patients aged between 33 and 62 years~     old ( 33 male, 25 female) received 65 FCRFPD prosthesis.~      All restorations were made indirectly on a plaster model using unidirectional E-glass fibers~     (Vectris- Ivoclar Vivadent, liechtenstein) in combination with a laboratory resin composite~     (Signum, Heraeus-Kulzer) and cemented according to the instructions of resin cement Variolink~     II (Ivoclar Vivadent). After baseline recordings, patients were followed at 6 months and~     thereafter annually up to 15 years. The evaluation protocol involved technical (chipping,~     debonding or fracture of tooth/restoration) and biological failures (caries).~   "
61304|NCT02764450|"~     This randomised, split-mouth clinical study evaluated the marginal quality of direct Class I~     and Class II restorations made of microhybrid composite and applied using two polymerisation~     protocols,~   "
61305|NCT02764437|"~     The investigators have identified areas of the brain that are activated in response to~     disease-related emotional information, following whole lung allergen challenge in asthma.~     They propose that activity in these central nervous system locations, as measured by fMRI, is~     associated with the intensity of allergic inflammation, provoked by segmental bronchial~     challenge, in the absence of significant airflow obstruction. The investigators predict that~     this relationship will be mediated by changes in expression of genes in the IL-1β/IL-17~     pathway.~   "
61306|NCT02764424|"~     Fight against the pain caused by the disease or by the diagnostic and therapeutic procedures~     is a daily and essential concern for the caregiver neonatologist. The quantification of pain~     is needed to effectively adjust analgesic therapy and by the way, to limit side effects.~     Several pain scales are now validated for newborns but they are based on one-off measures and~     hetero assessments often dependent on many factors including the operator.~      Recent developments in the real time analysis of the cardiac signal under the influence of~     autonomic control, have led to the development of a new painful stress index. A monitor has~     recently been developed by Mdoloris® company and provides an Analgesia and Nociception Index~     (ANI index in children and adults and NIPE index - for Newborn Infant Parasympathetic~     Evaluation - in newborns). It is based on the study of the heart rate variability and the~     variations of the sympathetic and parasympathetic indices to stimuli. The validation of this~     nociception index has not been validated in a neonatal unit where special attention is paid~     to pain control.~      The main purpose of our study is to show the consistency of this NIPE index (adapted to~     newborns) from 2 validated pain scales routinely used in neonatology in non-sedated children,~     hospitalized in intensive unit and neonatal intensive care unit from the University Hospital~     of Saint-Etienne (France).~      The study will involve 40 preterm or term newborn (i.e. with a gestational age between 26 and~     42 weeks and less than 3 months of life), hospitalized in neonatal intensive care units of~     our university hospital (Saint-Etienne - France), who have to acute painful stimuli related~     to their care.~   "
61307|NCT02764411|"~     Capillary Malformations (CM) affect a significant proportion of otherwise healthy children~     and may lead to psychological discomfort if left untreated. A significant proportion of~     untreated lesions undergo soft tissue thickening and darker discoloration later in life due~     to progressive ectasia of the affected vessels. While laser treatment is available, its use~     may be limited due to need for repeated sedation/general anesthetic use, partial response and~     cost.~      The investigators propose to conduct an open-label, prospective, cohort study using Onreltea~     ( Brimonidine) gel for treatment of facial capillary malformations in children. The study~     medication will be applied topically on affected area of the skin daily for 12 weeks. Follow~     up visits will occur at at Week 1,4,8,12, and 16 to assess the efficacy and safety of the~     proposed treatment.~      The study second aim is to explore the feasibility of conducting a multicenter placebo~     controlled study.~   "
61308|NCT02764398|"~     Background: Serious adverse cardio-respiratory events (SCRE) occur during super selective~     ophthalmic artery chemotherapy for retinoblastoma in children. SCRE mechanism remains unclear~     but may be attributed to an autonomic nervous reflex induced by catheterization of the~     ophthalmic artery. The investigators hypothesize that inadequacy between depth of anesthesia~     and catheter stimulation might be a support cause of these SCRE.~      Methods: Children requiring super selective ophthalmic artery chemotherapy for retinoblastoma~     are prospectively included in this observational study. Endovascular procedures are performed~     under standardized and deep general anesthesia with sevoflurane, sufentanil and rocuronium.~     SCRE are strictly pre-defined and included arterial hypotension, bradycardia and~     bronchospasm. SCRE are recorded and the factors influencing their occurrence are~     investigated.~   "
61309|NCT02764385|"~     This study will compare the effectiveness of two approaches for delivering smoking cessation~     advice in the primary care setting. Ask-Advise-Connect (AAC) is a strategy that uses the~     electronic health record (EHR) to prompt clinical staff to Ask if the patient smokes, Advise~     them to quit and, if they're interested, Connect them to Quitline (QL) counseling services.~     The connection occurs when a QL counselor is notified of the patient's interest, and then~     calls the patient to enroll in treatment. AAC has been shown to be very effective at~     enrolling patients, however, it was found that less than 42% of patients who agreed to be~     referred were successfully contacted by the QL after 5 call attempts. This indicates that~     many patients that are referred are not ready for cessation, but may feel obligated to accept~     the referral from their primary care team. This presents an opportunity to improve the~     patient centeredness of the referral process.~      To overcome these limitations, the investigators propose pairing it with a patient-centered~     smoking cessation approach called the Teachable Moments Communication Process (TMCP). The~     investigators' team developed this communication strategy, which incorporates patients'~     concerns into a partnership-oriented discussion about smoking cessation. The investigators~     propose that combining these two approaches could increase appropriate referrals to the QL,~     increase the likelihood of successful patient contact and enrollment, and increase the~     patient's rating of the value of the experience.~   "
61503|NCT02761863|"~     This is a prospective study evaluating the effect of expression of CD74 and VEGF on outcome~     of treatment in patients with malignant pleural mesothelioma receiving Pemetrexed/Platinum~     protocol. The paraffin blocks of the patients will be tested for CD74 and VEGF before~     starting treatment using IHC and the results will be correlated with the outcome of treatment~     during evaluation.~   "
61311|NCT02764359|"~     Obesity alters the movement through the body of several antibiotics, including vancomycin.~     Based on literature to date, total body weight should be used to determine dosages and~     shorter dosing intervals may be needed. However, hospitals have different approaches to~     managing vancomycin in this patient population. The most common example is not exceeding a~     dose of 2,000mg of vancomycin at one time in these patients. However, some institutions~     including the Charleston Area Medical Center do not have a set maximum one time dose. To~     date, a study has not been done comparing two different dosing regimens in obese patients to~     determine if having a maximum dose cap is beneficial.~      This research study is attempting to add to the limited existing body of literature regarding~     vancomycin dosing in obese patients. The investigators hypothesize that optimizing the~     initial or loading vancomycin dose that obese patients receive will decrease the time to~     target concentrations. For this study, obese adult patients will be randomized to receive~     either 1) a loading dose of 20 mg/kg with a maximum dose up to 2,000mg OR 2) a loading dose~     of 20 mg/kg with a maximum dose of up to 4,000mg. The study's primary aim is to determine~     differences in the time needed to achieve target vancomycin concentrations and the occurrence~     of adverse events.~   "
61312|NCT02764346|"~     This study will look at the use and impact of smartphone application (app) for adolescents~     with ongoing pain caused by their juvenile idiopathic arthritis (JIA).The current project~     will include three studies. First, the investigators conducted usability sessions with~     adolescents with JIA to refine the app so that it is usable, acceptable and understandable.~     The aim of this study is to look at (a) how regularly the iCanCope with Pain app is used~     and (b) any effect the app has on young people's health. This study will compare two groups~     of young people: one that is using the new app, and one that receives usual medical care.~   "
61313|NCT02764333|"~     This is a Phase 2 clinical trial, which tests two investigational drugs: TPIV200/huFR-1 (also~     called TPIV200), which is a vaccine consisting of proteins from the folate receptor alpha~     mixed with GM-CSF, and durvalumab (MEDI4736) , which is an antibody drug that help un-block~     parts of the immune system. The aim of this study is to find out whether these drugs, when~     given together are safe, and whether they are effective in treating cancer.~   "
61314|NCT02764320|"~     There are two commonly used treatment strategies for treating patients who have chronic~     migraine with medication overuse. This study will compare the outcomes amongst patients~     randomized to one of the two treatment strategies.~   "
61315|NCT02764307|"~     Background: Nebulizers design influences efficiency of aerosol delivery. Performance of~     nebulizers is commonly tested by breathing simulators with static parameters. However,~     breathing patterns vary in adults.~      Objectives: The purpose of this study was to evaluate drug deposition of different types of~     nebulizers testing with breathing patterns of healthy subjects.~   "
61316|NCT02764294|"~     Cystoscopy is a pain procedure and patients may experience anxiety and dissatisfaction before~     and during the procedure. Especially male patients feel more pain than females during~     cystoscopy. The aim of this study is to compare effectiveness of three different distraction~     methods on pain, anxiety and satisfaction of the male patients during cystoscopy.~   "
61317|NCT02764281|"~     The purpose of this study is to evaluate the efficacy and safety of methotrexate, etoposide,~     pegaspargase and dexamethasone (MEDA) chemotherapy and autologous hematopoietic stem cell~     transplantation (Auto-HSCT) in patients with stage IV extranodal natural killer/T-cell~     lymphoma, nasal type.~   "
61318|NCT02764268|"~     Apatinib dose titration in Advanced or Metastatic Gastric Cancer~   "
61319|NCT02764255|"~     cases with embyos cultured in the standard incubator and evaluated only by morphology are~     compared to cases with embryos continuously monitored by the embryoscope followed by embryo~     selection based on a multivariable model~   "
61320|NCT02764242|"~     Study the causative insect by skin prick test and sIgE to wasp, bee and fire ants are~     important but false positive by crossreactivity can occur. sIgE to recombinant venom allergen~     is proposed to help in finding the causative insect.~   "
61321|NCT02764229|"~     The purpose of this study is to allow subjects completing study LYC-30937-2001 the~     opportunity to receive LYC-30937-EC 25 mg.~   "
61322|NCT02764216|"~     The optimal treatment of HNCUP remains controversial and lacks evidence from prospective~     randomized trials. The management of these patients relies primarily on surgery and~     radiotherapy. The role of radiotherapy in sterilizing putative mucosal sites remains~     controversial. The main debate concerns the extent of the radiation field. Although~     pan-mucosal irradiation from the nasopharynx to the hypopharynx and bilateral neck nodes~     reduces the risk of emergence of a mucosal primary or a nodal relapse, it has been associated~     with significant toxicity and long-term morbidity (mostly xerostomia and dysphagia). Most~     single institution retrospective studies have not shown any advantage for more extensive~     irradiation.Therefore, elective mucosal irradiation may might be appropriate only for these~     patients.~   "
61323|NCT02764203|"~     The COCOA-BP Trial is designed to assess the impact of 50g daily dark chocolate intake on~     blood pressure and compare outcome data derived from wearable/digital health devices to data~     derived from standard methods. Additionally, the usability of the wearable technology will be~     evaluated.~   "
61324|NCT02764190|"~     Adolescents have some of the highest rates of risk behaviors of all age groups and health~     behaviors developed in adolescence can persist into adulthood. These behaviors carry~     significant risks for subsequent disease, disability, and healthcare burden. Despite these~     risks, health risk screening in primary care is infrequently performed and results are rarely~     followed by targeted intervention. In response to the need for screening-linked~     interventions, our study team has developed a web-based, electronic Personalized Motivational~     Feedback tool which we refer to as Check Yourself. Based on motivational interviewing, a~     technique to mobilize personal change, Check Yourself is designed to promote healthy choices~     for the multiple behaviors relevant to adolescents as well as to provide information to~     providers to promote discussions around health behaviors between providers and adolescents.~      Building on electronic health interventions, primary care providers can play an essential~     role in helping adolescents to make healthy behavior choices. Emerging evidence suggests that~     the consistency of preventive counseling can be increased through provider training and the~     provision of screening tools; yet, we know very little about the quality of such counseling,~     and if it impacts outcomes that are important to adolescent patients themselves.~      This study is a stepped-wedge, controlled trial comparing the effectiveness of an interactive~     adolescent-centered training for primary care providers (I-ACT) and Check Yourself to usual~     care. This study will take place in six pediatric practices. The purpose of this study is to~     determine whether this system of interventions (i.e., I-ACT, Check Yourself, and the summary~     report) is more effective than usual care in reducing health risk behaviors, improving~     adolescent motivation for health, and improving quality of care among adolescents receiving~     primary health care services.~   "
62696|NCT02746237|"~     Safety, tolerability, pharmacokinetics (PK), cardiac conduction and food effect study on~     single and multiple ascending doses of KAR5585 in healthy adults.~   "
61325|NCT02764177|"~     Whilst the effects of manipulating the macronutrient content of foods on appetite and energy~     intake has been relatively well studied at rest, little is known about these responses in a~     post-exercise context. The effect of post-exercise nutrition on recovery from or adaptation~     to exercise has been well studied. However, many exercisers do so for weight management and~     thus any post-exercise nutrition might impact on energy balance and might need to be~     carefully considered. This study will examine the impact of manipulating the composition of a~     recovery drink consumed after resistance exercise on subsequent appetite and energy intake.~   "
61326|NCT02764164|"~     Youths diagnosed with early onset schizophrenia will demonstrate amelioration of auditory~     hallucinations after one week of twice daily treatment with transcranial direct current~     stimulation (tDCS).~   "
61327|NCT02764151|"~     This study will evaluate the safety and tolerability of increasing doses of PF-06840003 in~     patients with malignant gliomas.~   "
61328|NCT02764138|"~     Racial and socioeconomic disparities in physical and mental health problems are large,~     persistent, and severe; begin during childhood; and stem from in part damage to physiologic~     stress response systems caused by chronic stress. Discovery of ways to prevent and/or halt~     this progression of damage to a child's stress response system may offer new directions for~     combatting health disparities. This project will evaluate the efficacy of a new prevention~     program designed to teach preadolescent children effective ways for coping with chronic~     stress that will have direct effects on their physiologic stress response systems~     (hypothalamic-pituitary-adrenal axis) and ultimately prevent onset of anxiety, depression,~     and post-traumatic stress symptoms and disorders.~   "
61329|NCT02764125|"~     This will be a randomised, crossover, double-blind, double-dummy, active-controlled,~     multicentre, phase II proof-of-concept study in Parkinson's Disease (PD) patients with~     end-of-dose wearing-off (motor fluctuations).~   "
61330|NCT02764112|"~     ASSESSING THE ABILITY OF WARFARIN TREATED PATIENTS TO PREDICT THEIR INR Kathleen McNamara,~     James Hoehns, Matthew Witry~      The international normalized ratio (INR) is the accepted lab test used to measure the~     intensity of warfarin effect. The conventional wisdom is that patients receiving warfarin are~     unable to correctly determine, in the absence of an INR result, whether or not they are~     therapeutic at any given time. Some warfarin treated patients express that they have insight~     into what their INR result will be. Various patient related factors may contribute to these~     opinions.~      Our objective is to assess how accurately patients can guess their INR result before it is~     obtained and to describe factors which inform their opinion of what their INR will be.~   "
61331|NCT02764099|"~     The proposed research is designed to adapt and test an evidence-based drug abuse prevention~     approach for use in youth courts among first-time, non-violent, adolescent offenders. The~     ultimate goal is to reduce the adverse health, legal, and social consequences of youth drug~     abuse, violence, and delinquency. Planned project activities include conducting: 1) key~     informant interviews of youth court directors regarding logistical and intervention features~     of effective youth court programming; and, 2) a randomized controlled efficacy trial of an~     adapted version of Life Skills Training, an evidence-based drug and violence prevention~     program. It is anticipated that the findings will provide critical information on~     implementing evidence-based prevention programs for new populations and settings and will~     support preparations for a large-scale effectiveness trial in youth peer courts.~   "
61332|NCT02764086|"~     This is a prospective non-randomised Phase I/II study with patients recruited to escalated~     dose cohorts. Escalated dose to the iGTV (internal gross tumour volume), with 60 Gy to the~     conventional PTV (planning target volume), will be delivered to successive cohorts of~     participants (6-12 participants/cohort) until the maximum tolerated oesophageal dose is~     determined. The minimum dose will be 60 Gy delivered via intensity modulated radiation~     therapy (IMRT) or volume modulated arc therapy (VMAT), planned on an Average Intensity~     Projection (AVIP) dataset.~      Standard of care chemotherapy.~      There will be two treatment arms; one with patients who are planned to receive neo-adjuvant~     or no chemotherapy, and the other with patients who are planned to receive concurrent~     chemotherapy.~   "
61333|NCT02764073|"~     Despite impressive improvements in treatment strategies, heart failure (HF) morbidity and~     mortality remains substantially high worldwide. Pulmonary congestion is considered the~     leading cause for hospital admissions and death among patients with HF. Physical examination~     is crucial for titrating medical treatment in these patients, but despite a good specificity~     it is not sensitive enough to detect early elevated cardiac filling pressures.~      The N-terminal pro-B-type natriuretic peptide (NT-proBNP) is a recognized powerful predictor~     for HF prognosis. Recently, cardiotrophin-1 and galectin-3 have been proposed as new relevant~     biomarkers for HF evaluation.~      Echocardiography can be also used to noninvasively measure left ventricular filling~     pressures. Lung ultrasound (LUS) through interstitial B-line evaluation has been recently~     proposed as a bed-side, noninvasive tool to assess interstitial lung water. B-lines correlate~     with NT-proBNP and E/e' levels in patients with acute dyspnea, chronic HF or after a stress~     test. LUS can also identify clinically silent pulmonary edema, suggesting that it may~     complement clinical evaluation to improve hemodynamic profiling and treatment optimization.~      Biompedance is a bedside method for total body fluid status assessment. It defines individual~     fluid status/compartments/overload on the basis of an individual's normal extracellular~     volume and body composition. Recent studies indicate that bioimpedance-derived fluid overload~     indices are independent predictors of mortality in renal failure patients.~      To date, no study has evaluated bioimpedance performance for fluid assessment in HF patients.~     The investigators aim to cross-sectionally compare bioimpedance parameters with clinical~     evaluation, LUS, cardiac biomarkers, and echocardiographic characteristics, in a cohort of~     incident consecutive patients with HF. Two years patients' survival will be evaluated to~     propose the best evaluative algorithm and rank the various methods for prognostic~     significance.~   "
61334|NCT02764060|"~     The aim of this study was to examine in periodontitis patients with visible tongue coating~     the changes in microbial load (aerobic and anaerobic) of the 14 day use of a tongue scraper~     versus the use of a regular toothbrush to clean the tongue.~   "
61335|NCT02764047|"~     Evaluate the effect of supplementation of probiotics on liver changes (histological and~     enzymatic), lipid profile and gut microbiota of patients with nonalcoholic steatohepatitis~     (NASH).~   "
61385|NCT02763397|"~     The existing DBS setting in patients with DBS of the globus pallidus interna (GPi), which~     aims to treat motor symptoms by a high-frequency stimulation, will be temporarily reprogramed~     to stimulate the NbM at a low frequency using the distal electrodes positioned in the~     vicinity of the NBM.~      This study aims to investigate the neuropsychological effect of low frequency stimulation of~     the nucleus basalis of Meynert (NBM) in advanced Parkinson's disease (PD) patients, who were~     previously treated with deep brain stimulation (DBS) of the globus pallidus interna (GPi).~   "
61336|NCT02764034|"~     The human endometrium is an extremely sensitive target. LLLT can enhance the proliferation~     rate of various cell lines, it produces higher rates of ATP, RNA, and DNA synthesis in stem~     cells and other cell lines. Thus, LLLT improves the proliferation of the cells without~     causing any cytotoxic effects.~      The aim of this work is to assess the ability of low level laser therapy in enhancing~     endometrial proliferation and increasing endometrial receptivity.~      A number of 120 human endometrial samples will be studied, and will be collected from 40~     infertile women attending the infertility clinic at NRC. Each human endometrial sample will~     be divided into 3 plates, in order to establish 3 main groups of 40 culture plates for single~     laser exposure group versus 40 culture plates for multiple laser exposure group and 40 tissue~     culture plates for control samples, thus a total of 120 tissue culture plates will be~     studied, the study groups will be exposed to low level laser therapy and compared to their~     matched controls.. Assessment of number and size of cells after LLLT as a marker of normal~     proliferation and b) The expression of Integrin aVB3 alpha v B3, MUC-1 and LIFand the~     development of pinopodes on the surface of epithelial cells as markers of endometrial~     receptivity and the detection of PTEN tumor suppressor gene as a marker of abnormal~     proliferation or premalignant condition will be performed to assess the effect of LLLT on the~     endometrial cell culture. This study might offer a new therapeutic modality which might~     increase endometrial thickness and enhance receptivity .~   "
61337|NCT02764021|"~     Scientific evidence for the dietary treatment of type 2 diabetes (T2D) is insufficient. The~     study group hypothesizes that a lower carbohydrate content in the diabetic diet than the~     recommended 55 energy percentage (E%) will decrease the postprandial glucose excursion. This~     will reduce postprandial insulin concentration, which together with lower glucose~     concentration leads to less fat accumulation in the liver and muscle tissue, resulting in an~     improved insulin sensitivity which together with a reduced glucose load improves the glucose~     metabolism. This clinical study will examine in subjects with type 2 diabetes the effect of~     highly controlled dietary low carbohydrate intervention on metabolic pathways with respect to~     insulin action, pancreatic islet function, lipid metabolism, ectopic fat accumulation,~     incretin hormones, low grade inflammation in plasma and adipose tissue, novel measures of~     fatty acid metabolism, and heart rate variability, respectively. The studies exhibit the~     potential to reform dietary recommendation aiming to prevent and ameliorate type 2 diabetes.~   "
61338|NCT02764008|"~     Percutaneous nephrolithotomy (PCNL) is a safe and effective procedure that is considered the~     standard treatment for large and complex renal stones. Although it has lower complication and~     morbidity rates than open surgery, the pain and discomfort related to a nephrostomy tube can~     cause distress for patients.~      Managing this pain with opioids can lead to sedation, nausea, vomiting, and constipation,~     which defeat the purpose of this minimally invasive procedure.~      Skin infiltration with bupivacaine around the nephrostomy tube is not effective. Infiltration~     of renal capsule has shown to facilitate painless insertion of nephrostomy tube, suggesting~     the role of renal capsule in pain management.~      Peritubal infiltration of bupivacaine from renal capsule to the skin along the nephrostomy~     tract may alleviate postoperative pain. A unilateral Low thoracic paravertebral (PVB) block~     offers the option of providing extendable perioperative pain relief without the above side~     effects or the physiologic derangement associated with local anesthetics in the central~     neuraxial space.~      The aim of this study is to determine whether ultrasound guided low thoracic paravertebral~     block effective post-operative analgesia as compared to peritubal infiltration analgesia in~     patients undergoing percutaneous nephrolithotomy.~      Main outcome measures: The primary endpoint is postoperative opioid consumption. Secondary~     endpoints are visual analogue pain scores, opioid related side effects.~   "
61339|NCT02763995|"~     Cardiovascular diseases (CVD) are the main cause of death in Spain. In HIV patients, the~     uncontrolled viral replication, antiretroviral therapy (ART) and coinfections contribute to~     develop metabolic diseases and increase the prevalence of risk factors for CVD. These~     patients are aging which results in a higher probability of comorbidities, increased number~     of medications, possibility of having a negative outcome associated with medication (NOM) and~     increased cardiovascular risk (CVR). Various studies have established that pharmaceutical~     care (PC) results in better control of cardiovascular risk factors.~      The purpose of this study is to evaluate the impact of pharmaceutical care achieved through~     pharmacotherapy follow-up on cardiovascular risk and health related quality of life (HRQoL)~     of HIV patients older than 50.~   "
61340|NCT02763982|"~     The purpose of this study is to determine whether ejection fraction and peak oxygen uptake~     have correlation on inspiratory muscle strength, chest wall volumes and quality of life in~     individuals with heart failure.~   "
61341|NCT02763969|"~     The purpose of this study is to establish if BMS-986202 is safe and effective at treating~     autoimmune diseases such as psoriasis. BMS-986202 which has shown some promise in preclinical~     studies for inhibiting autoimmune conditions such as psoriasis. This study will be the first~     time this drug is given to humans.~   "
61342|NCT02763956|"~     Degenerative Disc Disease is one of the most common spinal pathologies, affecting up to 10-15~     % of adults. The purpose of this study is to evaluate the efficacy of treatment with the~     GelStix™ device in a patient population with discogenic pain that had no benefit from~     conservative care.~   "
61349|NCT02763865|"~     The purpose of this study is to determine the effects of Low Frequency Repetitive~     Transcranial Magnetic Stimulation (LF r-TMS) of the pre-Supplementary Motor Area (pre-SMA) on~     tremor as measured by the tremor rating scale (TRS) in patients with Essential Tremor (ET).~      Hypothesis: Pre-SMA LF r-TMS will result in a >30% reduction in tremor as measured by the~     TRS. Another purpose of this study is to identify the mechanism by which LF r-TMS of the~     pre-SMA effects tremor in patients with ET.~      Hypothesis: Inhibition of the pre-SMA by LF r-TMS improves tremor in ET by normalizing~     pre-SMA output, and improving motor control, as determined shortening of the delay in the~     second agonist burst, seen in ET patients. At conclusion of this study expect to have~     sufficient pilot data to justify larger pivotal trials designed to establish the efficacy of~     pre-SMA r-TMS in ET.~   "
61350|NCT02763852|"~     The purpose of this study is to investigate the tolerability, pharmacokinetic profile of BIA~     3-202 and its metabolites, and the pharmacokinetic and pharmacodynamic interaction between 4~     different single doses of BIA 3-202 (50 mg, 100 mg, 200 mg and 400 mg) and a single dose of~     standard levodopa 100 mg/benserazide 25 mg (Madopar® 125) in adult male and female healthy~     volunteers.~   "
61343|NCT02763943|"~     There is a lack of data analyzing the influence of Cardio-vascular Diseases (CVD) risk factor~     control on graft survival disparities in Black transplant recipients. Studies in the general~     population indicate that CVD risk factor control is poor in Black patients, leading to higher~     rates of renal failure and CV events. However, with the exception of hypertension, there is~     paucity in data demonstrating similar results within transplant recipients. Recent analyses~     conducted within our transplant program, indicate that CVD risk factors, especially diabetes,~     are poorly controlled in Black recipients, which likely impacts graft loss. Since these data~     were collected in a retrospective manner, larger analyses are needed to validate these~     exploratory findings.~      This pilot study is to:~        1. Determine if the study is feasible, as measured by the proportions of enrolled to~          approached and completed to enrolled.~        2. Measure and compare, at baseline versus the end of the intervention, the medication~          safety events, including the number of medication errors, medication non-adherence and~          medication side effects, in patients enrolled in the study~        3. Measure and compare, at baseline versus the end of the intervention, CVD risk factor~          control, including hypertension, diabetes and dyslipidemia, in patients enrolled in the~          study~        4. Measure and compare, at baseline versus the end of the intervention, patient reported~          survey results, in patients enrolled in the study~        5. Determine if the impact of the intervention is more pronounced in Black recipients, as~          compared to non-Black recipients~   "
61344|NCT02763930|"~     Market trends depicted by Agriculture and Agri-Food Canada suggest stagnation in cheese~     consumption, with potentially important impact on this key industry in Canada. This is in~     part due to the commonly accepted notion that saturated fat in the diet, of which cheese~     contributes significantly, increases the risk of heart disease. Yet, a rather large body of~     recent evidence suggests that saturated fat may have been unfairly demonized and that its~     impact on the risk of heart disease may in fact be less important than originally thought.~     This concept that dairy fat increases the risk of heart attacks therefore needs to be~     revisited.~      The proposed research is designed to investigate which risk factors for heart disease (e.g.~     cholesterol, blood pressure) are beneficially modified when low fat (milk) and high fat~     (cheese) dairy products are consumed.~      Our hypotheses are : (1) Consumption of low fat dairy (milk 1% fat) compared with a~     dairy-free control diet reduces daytime ambulatory systolic blood pressure and reduces~     inflammation; (2) Consumption of a high fat dairy (GABA-rich cheese) compared with a~     dairy-free control diet reduces daytime ambulatory systolic blood pressure and has favorable~     effects on LDL particle size, inflammation and HDL-C concentration.~   "
61345|NCT02763917|"~     Background: Asthma and obesity are public health crises that have concurrently risen over the~     past decades, affecting millions of children in the United States and disproportionately~     affecting low-income minority children in urban areas. The same children at highest risk for~     asthma and obesity also have greater exposure to indoor and outdoor pollution. Emerging~     evidence suggests that obesity may confer increased susceptibility to health effects of air~     pollution.~      Methods: Aiming to provide causal-level evidence of these observational findings, we propose~     a home intervention study to 1) test whether targeted reductions of indoor Particulate Matter~     (PM) concentrations improve the respiratory health of overweight inner-city children with~     asthma more than that of lean inner-city children with asthma and 2) investigate mediators of~     susceptibility to indoor PM among overweight versus lean children with asthma. We will~     accomplish these aims using a 1:1 randomized controlled trial of 200 children with persistent~     asthma (half normal weight, half overweight) living in Baltimore City. Participants will be~     randomized to receive either two active air purifiers containing high-efficiency particulate~     air (HEPA) filters or two sham air purifiers with their filters removed.~      Implications: If the aforementioned observational findings are confirmed, implications will~     be directly relevant to the over 170 million children around the world now estimated to be~     overweight or obese.~   "
61346|NCT02763904|"~     Protein-calorie malnutrition is a frequent comorbidity in hospitalized patients and there is~     evidence that the nutritional status may influence the response to drug treatment, mortality,~     susceptibility to infections, the patient's functional status, duration of hospital stay and,~     consequently, overall healthcare costs. The causes of malnutrition are manifold. The~     underlying disease may in fact lead to an increase in the patient's energy needs, whether or~     not associated with a reduction in caloric intake. The same therapeutic treatments can~     further worsen the energy balance without considering that the patient can be kept fasting~     for the execution of some diagnostic procedures. Therefore, a further deterioration of~     nutritional status during hospitalization could occur.~      International guidelines underline the utility to set a nutritional support whenever this is~     necessary, not only to prevent or treat malnutrition but also improve clinical outcomes. In~     this perspective, the improvement of oral diet and the use of oral nutritional supplements~     (ONS) represent the first-line strategy of intervention. Previous studies have shown that~     nutritional counseling, with or without the use of ONS, in patients with chronic disease is~     able to improve the calorie-protein intake, prevent deterioration of nutritional status, as~     well as to increase to a certain extent body weight. Particularly, energy-dense are more~     effective in increase energy intake. These data have highlighted the importance of a proper~     evaluation of the nutritional status of early detection of patients who could benefit of~     nutritional support. However, the independent role of the ONS in improving clinical outcome~     still needs to be established.~   "
61347|NCT02763891|"~     This study evaluates the effect of body suspension and tilting exercises (performed in~     Chordata apparatus) on the balance and mobility of subjects with Parkinson disease. Half of~     patients will perform the exercise protocol while the other half will receive passive muscle~     stretching and maintain the usual routine.~   "
61348|NCT02763878|"~     The investigators intend to conduct multi-center randomized controlled study to find if Uncut~     Roux-en-Y anastomosis to the distal gastric cancer patients after radical D2 can reduce the~     long-term complications, affect the quality of life, and improve the prognosis, comparing to~     Billroth II anastomosis.~   "
61351|NCT02763839|"~     The purpose of this study is to investigate the tolerability, pharmacokinetic profile of BIA~     3-202 and its metabolites, and the pharmacokinetic and pharmacodynamic interaction between 4~     different single doses of BIA 3-202 (50 mg, 100 mg, 200 mg and 400 mg) and a single dose of~     standard levodopa 100 mg/carbidopa 25 mg (Sinemet® 25/100) in adult male and female healthy~     volunteers.~   "
61354|NCT02763800|"~     The objectives as stated in the study protocol were as follows:~        -  To investigate the safety and tolerability of three multiple dose regimens of BIA 3-202~          (50 mg twice a day, 100 mg twice a day and 200 mg twice a day in healthy young male~          volunteers). Part A~        -  To characterise the steady state pharmacokinetic and pharmacodynamic profile of BIA~          3-202 in healthy young males. Part A~        -  To investigate the safety and tolerability of a single multiple dose regimen (dose to be~          determined from Part A) of BIA 3-202, in healthy elderly volunteers. Part B~        -  To characterise the steady state pharmacokinetic and pharmacodynamic profile of a single~          multiple dose regimen (dose to be determined from Part A) of BIA 3- 202 in healthy~          elderly volunteers. Part B~   "
61355|NCT02763787|"~     The purpose of this study is to investigate the safety and tolerability of single oral rising~     doses of BIA 3-202 up to 800 mg (proposed doses 10 mg, 30 mg, 50 mg, 100 mg, 200 mg, 400 mg~     and 800 mg) in groups of 9 healthy male adult subjects, to characterise the preliminary~     pharmacokinetics of single rising oral doses of BIA 3-202 in healthy male adult subjects, to~     investigate the effects of single doses of BIA 3-202 on COMT activity in human erythrocytes~     and to investigate the effect of food on the pharmacokinetics of a single dose of BIA 3-202.~   "
61356|NCT02763774|"~     This study aims to analyze effects of three types of cardiac rehabilitation protocol on~     fuctional capacity, inflammatory markers, pulmonary function and clinical outcomes after~     coronary artery bypass grafting (CABG) in patients with left ventricular disfunction.~     Patients will be randomized and allocated in three groups according to type of exercise~     protocol: 1. walk; 2. cycle; 3. functional electrical stimulation.~   "
61357|NCT02763761|"~     The purpose of this study is to compare the effects of Infliximab and oral prednisone versus~     methylprednisolone and oral prednisone in patients with melanoma, lung cancer, or renal cell~     carcinoma who have immune related Grade 3-4 diarrhea for up to 3 days or persistent Grade 2~     diarrhea for more than 5 days after treatment with Yervoy and/or Opdivo~   "
61358|NCT02763748|"~     Gastric stromal tumor is a gastrointestinal mesenchymal tumor with malignant differentiation~     potential, the incidence increased year by year. The surgical resection is the primary~     treatment for it. Although laparoscopic GIST resection has many benefits，due to in lack of~     the delicate sense of touch, it could lead to the incomplete resection and disorders of~     digestion. More than 33% of postoperative patients have the gastric dysfunction. Laparoscopic~     endoscopy combined surgery is different from the past technology. It is a new radical~     resection of GIST presented by Japanese scholars. LECS resects the tumor completely by~     laparoscopy with the help of the precise positioning and guidance of endoscopy .This method~     conforms to the idea of the modern minimally invasive surgery, and avoids many problems，such~     as incomplete resection and disorders of digestion caused by excessive tissue resection. our~     team will spearhead the GIST treatment of LECS. First of all, the investigators will collect~     120 cases of GIST patients, randomly assigned for the laparoscopic group, the LECS,~     single-arch the LECS surgical treatment. Secondly, to analyzing the basic treatment and~     follow-up data, including the operation time, blood loss, the number of transfer laparotomy,~     the number of cut edge positive, the distances of cut edge away from the tumor edge, the~     cases of anastomotic fistula bleeding, stenosis, average such confinement, the meal time,~     cost of treatment, tumor recurrence rate, the presence of residual stomach, upset stomach and~     frequency, reflux esophagitis, bile reflux gastritis and other indicators.The purpose of this~     subject is to observe the effectivity and safety of LECS and single-arch the LECS, invent~     serval LECS equipment patents and provide some references for LECS applying to the minimally~     invasive surgery of the digestive tract tumor and multidisciplinary treatment mode .~   "
61359|NCT02763735|"~     The purpose of this study is to use non-invasive imaging to determine the metabolic phenotype~     of the right ventricle in patients with pulmonary arterial hypertension across a spectrum of~     disease severity.~   "
61360|NCT02763722|"~     Atopic dermatitis (AD) is a chronic, relapsing, inflammatory skin disease that has potential~     for profound and far-reaching effects on all aspects of children and their families lives,~     significantly reducing the quality of life. Atopic dermatitis typically appears in infancy~     and nowadays is affecting up to 10-30% of children and 2-10% of adults.~      Diminished skin barrier is the essential factor that plays a role in the initiation,~     consolidating and exacerbating AD. Treatment options for AD typically address skin barrier~     protection or inflammatory components of disease. Proper care using mild and appropriately~     formulated emollient preparations may provide significant benefits.~      In investigators prior study, more than half of pharmacy-derived emollient preparations~     contained potential contact haptens listed in the European baseline series (EBS), used in~     diagnosing contact dermatitis.~      The primary aim of this study is to demonstrate the efficacy of regularly applied emollient~     in an atomiser (in the form of oil-in-water emulsion) in maintenance therapy, in children~     presenting from mild to moderate atopic dermatitis.~      In this study 3 visits are planned (for a period of 4 weeks). During each visit investigators~     will evaluate transepidermal water loss (TEWL), capacitance of outer areas of the stratum~     corneum as an indirect assessment of skin hydration. Moreover, investigators will assess~     three-them-severityIndex and the Children's Dermatology Life Quality Index (CDLQI).~      The product that participants will use in the study, was prepared at investigators request,~     in collaboration with the cosmetics company, which according to investigators knowledge at~     present, will not be benefited from the audit. The following described study project~     (prospective clinical trial, uncontrolled, open-label) will be conducted within the framework~     of the statutory tasks of the Department of Pulmonology and Allergology of Children Medical~     University of Warsaw and is a non-commercial project.~   "
61361|NCT02763709|"~     Intensive Care Unit Acquired Weakness(ICUAW) encompasses a spectrum of disorders~     characterized by generalized weakness developing after the onset of critical illness.~     Pediatric data on the incidence of ICUAW is restricted to isolated case reports and case~     series of no more than five children. Critical illness polyneuropathy is characterized by~     reduction in compound motor action potential or sensory nerve action potential or both with~     preserved conduction velocity on electrophysiological studies. These findings can occur very~     early prior to the onset of clinical features. Given the dearth of data in children on the~     subject, this study has been planned to evaluate the incidence of critical illness associated~     polyneuropathy /myopathy in severely sick children admitted.~   "
61371|NCT02763579|"~     This randomized, Phase I/III, multicenter, double-blinded, placebo-controlled study is~     designed to evaluate the safety and efficacy of atezolizumab (anti-programmed death-ligand 1~     [PD-L1] antibody) in combination with carboplatin plus (+) etoposide compared with treatment~     with placebo + carboplatin + etoposide in chemotherapy-naive participants with ES-SCLC.~     Participants will be randomized in a 1:1 ratio to receive either atezolizumab + carboplatin +~     etoposide or placebo + carboplatin + etoposide on 21-day cycles for four cycles in the~     induction phase followed by maintenance with atezolizumab or placebo until progressive~     disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid~     Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD~     or symptomatic deterioration.~   "
61372|NCT02763566|"~     The main purpose of this study is to evaluate the efficacy of the study drug abemaciclib in~     postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor~     receptor 2-negative (HER2-) locoregionally recurrent or metastatic breast cancer.~   "
61362|NCT02763696|"~     The vaginal microbiota is an important biological barrier for host against pathogens or~     opportunistic pathogens. Undermining the balance of the vagina is closely related to~     infectious diseases and tumors.~      The vaginal microbiota of child-bearing women of age is dominated by Lactobacillus species,~     including major four species: Lactobacillus crispatus, Lactobacillus jensenii, Lactobacillus~     gasseri and Lactobacillus iners, followed by obligate anaerobes such as Gardnerella~     vaginalis, Atopobium vaginae, Mobiluncus curtisii, and Prevotella .~      Currently, There are almost 99% bacteria can not to be found with bacterial culture. Based on~     microscopy and conventional culture method to obtain vaginal microflora information have a~     variety of deviation. For this reason, The in-depth study of complex vaginal flora and the~     correct understanding of disease faces a serious obstacle. With the development of~     High-throughput sequencing technology， metagenomics can get all the composition and~     distribution of microorganisms from the sample which traditional knowledge may not be with~     microorganism culture method. Therefore, Re-evaluation of existing microflora diagnostic~     criteria for clinical diagnosis of the disease is necessary.~      In this study, the investigators use high-throughput sequencing technology to detect women of~     childbearing age vaginal microflora of metagenomic distribution. Including bacteria, fungi,~     viruses, protozoa, and other microorganisms. Based on the study results of metagenomic, the~     investigators want to re-cognition thenormal floraof women of childbearing age ,and develop~     vaginal microflora microscopic evaluation of the integrity of the reference standard.~   "
61363|NCT02763683|"~     The purpose of this study is to use a brain imaging method called Pittsburgh B (PIB) Positron~     Emission Tomography (PET) and Vesicular Cholinergic Transport (VAT) PET to determine dementia~     subtypes in patients with Parkinson disease (PD). The ultimate goal of this project is to be~     able to identify individuals with PD who are at risk of developing dementia, and to~     distinguish the underlying cause of dementia.~   "
61364|NCT02763670|"~     The heart failure is a chronic pathology with prevalence from 2 to 3% of general population,~     a death rate of 50% at 6 months for patients with stage IV, and a probability of death or~     hospitalization or emergency consultation of 40% at 3 years. The care of patients is~     heterogeneous, especially in light of the organization of therapeutic education offered to~     patients and patient monitoring modalities.~      The aim of this study is to investigate the management strategies for patients with chronic~     heart failure stage III or IV NYHA, and heart failure patients with stage II NYHA with~     previous hospitalization for heart failure.~      This is a longitudinal observational multicenter study comparing a management strategy~     including patient education and monitoring as part of a hospital dedicated organization and~     an organization of care as usually done in France.~      The primary endpoint was a composite endpoint of morbidity and mortality involving deaths,~     unplanned readmissions and emergency visits for heart failure.~      The expected number of patients is 720 patients (360 per strategy). The follow-up duration of~     24 months.~   "
61365|NCT02763657|"~     Children's understanding of linear-order (e.g., Dan is taller than Lisa, Lisa is taller than~     Jess) and set-inclusion (i.e., All tulips are flowers, All flowers are plants) relationships~     is critical for the acquisition of deductive reasoning, that is, the ability to reach~     logically valid conclusions from given premises. Behavioral and neuroimaging studies in~     adults suggest processing differences between these relations: While arguments that involve~     linear-orders may be preferentially associated with spatial processing, arguments that~     involve set-inclusions may be preferentially associated with verbal processing. In this~     study, we use functional magnetic resonance imaging to investigate how and when these~     processing differences appear in children from 8 to 14.~   "
61366|NCT02763644|"~     This is a randomized, SoC-controlled, open-label, multi-center study in patients with TAM~     after hematopoietic precursor cell transplantation (HPCT) .~      Study will consist of up to 28 days of screening period, 16 weeks treatment period that can~     be extended to 45 weeks.Approximately 40 patients will be randomized to receive SoC or LFG316~     plus SoC. Patients will be included in the study if they have diagnosis of TAM and poor~     prognostic markers.~   "
61367|NCT02763631|"~     The aim of this study is to assess the benefit of a portable ventilator generating positive~     end-expiratory pressure on exercise tolerance in patients with Excessive dynamic airway~     collapse (EDAC) and tracheobronchomalacia (TBM).~   "
61368|NCT02763618|"~     This study will investigate the effects of an EEG theta/beta ratio Neurofeedback training~     using a case series multiple baseline design. Twelve participants will be assigned to one of~     three different groups that have a different time of intervention onset, or include placebo~     sessions only. The investigators will examine whether the theta/beta ratio Neurofeedback~     training will reduce resting state theta/beta ratio. As a pilot-exploration for future~     studies, also performance on a cognitive interference task will be monitored to see if any~     improvement after NFT on cognitive performance might be a viable subject for future studies.~     All participants (healthy, but selected for above-median theta/beta ratio in previous studies~     in this lab) will start with three resting state EEG baseline sessions, the first participant~     group then continues with 14 theta/beta ratio Neurofeedback sessions, the second group~     continues with six extra baseline EEG measurements, followed by eight Neurofeedback training~     sessions while the third group will continue with 14 placebo training sessions only. EEG~     resting state theta/beta ratio and interference performance will be measured during every~     session.~   "
61369|NCT02763605|"~     Acanthamoebic keratitis is an important corneal disease which may cause severe complication.~     The difficulty in diagnosis, the difficulty in treatment, and the long treatment process are~     factors leading to the poor prognosis of these patients. In this retrospective study, the~     investigators try to analyze the tissue proven Acanthamoebic keratitis diagnosed in our~     hospital. The investigators will focus on the in vivo confocal microscopic results, the~     medical history and the medical/surgical treatment outcome. The investigators will collect~     the tissue proven cases according to the data provided by laboratory diagnosis department and~     pathological department. The in vivo confocal microscopic results will be collected and~     analyzed. The investigators will also look through the photography of the external eyes from~     data stored in PAC system. The medical history and treatment outcome will be studied from~     clinical chart review. From this study, the investigators aimed to find out a easy way of~     diagnosing Acanthamoebic keratitis from in vivo confocal microscopy, and find out a better~     way for treatment.~   "
61370|NCT02763592|"~     The aim of this study is to evaluate the impact of 5% lidocaine medicated plaster on~     allodynic symptoms of localized neuropathic pain after knee surgery.~   "
61375|NCT02763527|"~     Background: Smokers attended to outpatient clinics present an excellent 'teachable moment'~     for smoking cessation interventions. This protocol paper describes the rationale and methods~     of a large randomized controlled trial which aims to evaluate the effectiveness of~     negotiating self-determination to reduce cigarette consumption among smokers attending~     outpatient clinics~      Methods: A randomized controlled trial will be conducted in 10 out-patient clinics in Hong~     Kong. Subjects in the intervention group will receive a brief intervention on smoking~     reduction plus a smoking reduction leaflet. Additionally, subjects will be asked to think~     about a smoking reduction schedule for themselves after the negotiation with the counsellor.~     Subjects in the control group will receive a brief advice on quitting plus a leaflet on~     smoking cessation. Four consecutive (1, 3, 6 and 12 months) follow-ups will be conducted. The~     primary outcome measure is biochemically validated abstinence at 6 months. Secondary outcomes~     are: (i) biochemically validated abstinence at 12 months, (ii) self-reported 7-day point~     prevalence of abstinence at 6 and 12 months, (iii) self-reported reduction of ≥ 50% in~     cigarette consumption at 6 and 12 months, and (iv) self-efficacy against tobacco at 6 and 12~     months.~   "
61376|NCT02763514|"~     The purpose of this study is to investigate the effects of EPA- and DHA-enriched omega-3~     polyunsaturated fatty acid dietary supplements on cognitive function (episodic memory,~     attention, working memory, executive function), subjective mood, alertness and mental fatigue~     after 26 weeks daily supplementation.~   "
61377|NCT02763501|"~     Comparison of participants in a randomised controlled trial (RCT) with observational data~     from patients operated in Sweden during the same period of time. The primary objective is to~     compare effects from a complex surgical intervention from RCT and observational data.~   "
61378|NCT02763488|"~     This study will evaluate blood flow restriction training as a rehabilitation modalities~     following total knee arthroplasty in order to determine if patient reported outcomes and~     objective functional outcomes can be improved through post-operative rehabilitation compared~     to standard physical therapy modalities currently in use.~   "
61379|NCT02763475|"~     The main goal of this study is to evaluate the anti-relapse prophylactic activity of~     inoculating Natural Killer (NK) cells as consolidation therapy of acute myeloid leukemia in~     paediatric patients with cytologic remission. The patients included have intermediate risk of~     relapse and no indication for allogeneic hematopoietic stem cell transplantation.~      After the standard induction and consolidation chemotherapy treatment, patients will receive~     five days of fludarabine to try to kill any minimal residual disease and prevent NK cell~     rejection. Two different NK cells infusions will be performed within one week (day 0 and 7).~     Interleukin 2 (IL-2) will be administrated to increase the cytotoxic activity of NK cells.~   "
61380|NCT02763462|"~     This study is an observational cohort study of hospitalized patients with fever. This study~     will collect demographic data, history of illness, signs and symptoms, results of laboratory~     tests, clinical course, treatment and outcome. This study conducted at eight INA-RESPOND~     hospitals. Potential study patients will be any patients (both children and adults).~   "
61381|NCT02763449|"~     The purpose of this study is to understand what happens when someone either becomes more~     active or more inactive. This study will measure your energy intake, energy expenditure, and~     body composition under normal conditions, when you become active, and when you become~     inactive.~   "
61382|NCT02763436|"~     The first major intervention a newborn infant is facing following birth is clamping of the~     umbilical cord. This means separation of the infant from the placenta, the newborn becomes an~     independent individual, especially from a cardio-circulatory perspective. Recent literature~     focused very much on the appropriate timing of the cord clamping (CC), distinguishing~     immediate cord clamping (ICC) from delayed cord clamping (DCC). Although potential benefits~     for DCC have been documented, especially for preterm infants, ICC still is the most widely~     used procedure. Although the reasons for this are unclear, a lack of understanding of the~     issues associated with umbilical cord clamping is thought to be a major underlying factor.~      In animal research with fetal lambs it has been shown, that aeration of the lung played a~     crucial role in undisturbed cardio-circulatory immediate neonatal transition. Thus a new~     concept of DCC was introduced, delaying cord clamping until ventilation/aeration of the lung~     was established, calling this Physiological-Based Cord Clamping (PBCC). It was shown, that~     PBCC improved not only cardiovascular function in preterm lambs, but systemic and cerebral~     oxygenation too. Systemic oxygenation was measured using pulseoximetry, and cerebral~     oxygenation was measured using near infrared spectroscopy (NIRS).~      Until now, human data for PBCC are lacking. Therefore, the aim of the present study is to~     investigate whether PBCC is able to improve systemic and cerebral oxygenation in term infants~     delivered vaginally.~   "
61383|NCT02763423|"~     This is a phase II trial in individuals who have been diagnosed with type 1 diabetes within~     the previous 12 months and suffered from diabetic ketoacidosis at onset of disease. The~     purpose of this study is to determine whether allogeneic umbilical cord mesenchymal stem cell~     transplantation is effective in the treatment of patients with severe type 1 diabetes.~   "
61384|NCT02763410|"~     Safety during transfusions is a major issue in medical economics. Despite drastic quality~     control measures, transfusion is still a source of short, mid and long-term morbi-mortality.~     This can be explained to some extent by changes in the composition of the packed red blood~     cell (PRBC) supernatant during storage essentially with the appearance of immunologically~     active compounds possibly involved in organ dysfunction on the one hand and post-transfusion~     immunomodulation on the other hand. These phenomena impact upon outcomes for cardiac surgery~     patients.~      In terms of organ dysfunction, kidney failure due to acute tubular necrosis and pulmonary~     failure are the 2 main issues. Following cardiac surgery, 11% of patients will present with~     transient renal dysfunction characterised by a 25% increase in serum creatinine levels and~     3.5% require dialysis. The intensity of acute renal failure (ARF) is correlated to~     resuscitation : a 20% increase in serum creatinine levels 2 to 3 days after surgery~     significantly raises morbidity rates and a 50% increase raises the mortality rate to 10%.~      The precise mechanisms governing post-transfusion immunomodulation have not yet to be~     defined. The appearance of soluble type I Human leukocytes Antigen (HLA) molecules (sHLA-I),~     the FAS ligand (FAS-L) or cluster designation 40 (CD40-L) in the supernatant of PRBCs along~     the storage of blood products may be involved in such phenomena. These molecules are capable~     of activating or triggering the death of innate or adaptive immunity cells, especially the~     Natural Killer (NK) cells.~      Consequently the investigators propose to focus specifically on the detailed composition of~     transfused PRBC supernatants in order to identify the candidate molecules responsible for~     organ dysfunction or post-transfusion immunoparalysis. The investigators will combine a~     clinical approach based on the transcriptional analysis of renal tubular cells in transfused~     patients and an ex-vivo approach investigating the effect of the supernatant on immune cells~     and the Natural Killer cells of healthy volunteers~   "
61386|NCT02763384|"~     The outcome of patients with relapsed or refractory adult T-acute lymphoblastic leukemia~     (T-ALL) and the related disease T-lymphoblastic lymphoma (T-LBL) is extremely poor with 30%~     of the patients responding to first salvage therapy and long-term survival of only 10%.~     Therefore, novel therapies for patients with relapsed/refractory T-ALL/LBL represent an unmet~     clinical need.~      Recent data provide strong evidence that CXCR4 signaling plays a major role in T-cell~     leukemia cell maintenance and leukemia initiating activity, and targeting CXCR4 signaling in~     T-ALL cells reduces tumor growth in an animal model. In this study, the investigators propose~     that the addition of BL-8040 to nelarabine as a salvage therapy for patients with~     relapsed/refractory T-ALL/LBL will result in a higher CR rate than nelarabine alone without~     an increase in toxicity and will allow patients to proceed to a potentially curative~     allogeneic hematopoietic cell transplant.~   "
61387|NCT02763371|"~     The Cognition Intervention Study Dortmund (CogniDo) and the Cognition Intervention Study~     Dortmund PLUS (CogniDo PLUS) investigated the short-term effects of having school lunch~     versus skipping it on children's basal (CogniDo) and executive (CogniDo PLUS) cognitive~     functions in the afternoon. The The Cognition Intervention Study Dortmund Continued (Coco)~     connected this two previous studies and investigates the effect of having school lunch versus~     skipping it on children's basal and executive cognitive functions later in the afternoon. The~     present study the Cognition Intervention Study Dortmund- Glycemic Index (CogniDo GI) examines~     the influence of the gylcemic index of lunch on cognitive performance of school children in~     the afternoon.~   "
61388|NCT02763358|"~     This study is designed to test the usability of the Bite Counter in an attempt to reduce~     participants' daily bites while also increasing their daily steps.~   "
61389|NCT02763345|"~     Community Case Management (CCM) is a clinical decision aid used by frontline Health~     Surveillance Assistants (HSAs) in Malawi to manage uncomplicated cases of pneumonia and~     malaria (amongst other conditions). Children identified has having complicated illness are~     urgently referred to larger health facilities better equipped to clinically manage these more~     complex presentations. There is evidence to suggest HSAs are missing opportunities to refer~     seriously ill children, and parents/caregivers are failing to comply with urgent referral~     recommendations when given; reducing the overall effectiveness of the CCM strategy. Use of~     mobile technology for deploying CCM has been demonstrated in prior research as feasible to~     evaluate, acceptable to health workers and parents/caregivers and improving health worker~     fidelity to the guidelines, but it is unknown if this translates into increased referral and~     referral completion rates. This trial seeks to evaluate the added value of a purpose~     developed mobile solution for CCM, called Supporting LIFE electronic Community Case~     Management (SL eCCM App) on HSA referral and parent/caregiver health seeking behavior.~   "
61390|NCT02763332|"~     The prevalence of the fibromyalgia is about 10-15% in the European countries. It is unclear~     the etiology and pathogenesis of the syndrome. Several factors such as dysfunction of the~     central and autonomic nervous systems, neurotransmitters, hormones, immune system, external~     stressors, psychiatric aspects, and others seem to be involved. But the symptom commonly~     expressed by the people who suffer from it is pain.~      The main goal of the present study is to analyse the effect of the kinesiotaping on the pain,~     comfort and postural position of the patient with fibromyalgia.~   "
61391|NCT02763319|"~     The purpose of the study is to compare the safety and efficacy of MOR208 with BEN versus RTX~     with BEN in adult patients with relapsed of refractory DLBCL.~   "
61392|NCT02763306|"~     A prospective, interventional, single-arm study to evaluate histologic changes in skin~     following cryotherapy with the study device.~   "
61393|NCT02763293|"~     Crohn's disease (CD) is an inflammatory bowel disease with a high prevalence. Its etiology is~     unknown and is considered a multifactorial disease. It is known that the existence of a~     genetic factor, industrialization and development of the country and environmental factors~     have great influence on the appearance of intestinal pathology (the Val; Buderus; Molodecky).~     CD is a chronic inflammatory bowel disease localized throughout the course of the digestive~     tract (oral-anal). The aim of this study is to evaluate the effect of a treatment program~     combining technical nonmanipulative appropriate in affected patients (CD) to increase the~     overall quality of life and related EC, lower abdominal pain direct and indirect osteopathic~     soft, observe the sense of change after treatment, and psychological aspects.~   "
61394|NCT02763280|"~     Recently, osteoporosis has been recognized as a serious health problem in the elderly, it has~     also increased in young • middle-aged layer. Ginseng is history 2, 000 years Korean typical~     herbal medicine which is used as a medicinal is known the mystery of Elixir from a long time~     ago. A previous study was administered ginseng extract results in animal models induced~     osteoporosis, the bone-related biomarkers, including improved bone density and bone mass.~   "
61395|NCT02763267|"~     It is unknown whether beta cell dysfunction and insulin resistance in Gestational Diabetes~     Mellitus (GDM) is representative of a chronic maternal defect, unmasked by pregnancy, or~     whether it is the result of an imbalance of a placental hormones. Undiscovered placental~     factors which vary between pregnancies likely contribute to the pathogenesis of GDM. To~     elucidate the pathophysiology underlying GDM, the investigators will attempt to discover~     these factors and characterize pregnancy-associated changes in insulin secretion and~     sensitivity in women with and without GDM.~   "
61396|NCT02763254|"~     To investigate the efficacy of autologous Epstein-barr virus (EBV)-specific T cells for the~     treatment of EBV positive Diffuse Large B Cell Lymphoma (DLBCL), Hodgkin Lymphoma (HL) and~     Post-transplant Lymphoproliferative Disease (PTLD) after failing first line treatment.~   "
61397|NCT02763241|"~     The investigators proposed that the Cleanoze® is superior to the traditional nasal saline~     irrigation in term of the ease of use which will resulting in a better quality of life of the~     participants. This study will compared the efficacy, adverse reactions, complications and~     ease of use of Cleanoze® comparing with normal saline solution~   "
61398|NCT02763228|"~     The purpose of this research study is to determine whether a physical activity (exercise)~     program in the community will improve the functional and overall health status of older women~     with a history of breast cancer. The physical activity or exercise program is designed for~     all older breast cancer survivors, and in particular for African-Americans and women of lower~     socio-economic status, who are the least likely to engage in physical activity.~   "
61399|NCT02763215|"~     This is a 24-month study to assess copper (Cu) parameters in subjects with Wilson Disease~     treated with standard of care (SOC) medications. Data will be collected during routinely~     scheduled Wilson Disease clinic visits at approximately 6-month intervals.~      After providing informed consent, subjects meeting all inclusion and no exclusion criteria~     will be enrolled into the study as outpatients. Subject's routine Wilson Disease clinic~     visits will be scheduled according to the standard clinical practice at the study center and~     at the discretion of the treating physician at approximate 6-month intervals.~      At the time of enrollment, subjects will be receiving SOC therapeutic agents for the~     treatment of Wilson Disease. If treatment is interrupted or stopped during the course of the~     study, subjects will continue in the study and biological samples and clinical data will~     continue to be collected for the full 24-month study period. Dosing with SOC agents, which~     can include penicillamine, trientine, zinc, or a combination of a Cu chelator and zinc, will~     be individualized and managed by the treating physician at the study center according to~     standard clinical practice at the site.~   "
61400|NCT02763202|"~     The purpose of this study is to better enhance transitions of care for the highest risk,~     complex patients, Carolinas HealthCare System (CHS) has designed an Integrated Practice Unit,~     called Transition Services (CHS-TS).CHS-TS aims to improve patient outcomes through~     innovative approaches that leverage analytics and technology, while bridging care~     coordination and communication gaps. During their hospitalization, CHS-TS patients enter into~     a transition pathway that includes the following key services: integrated access to medical,~     pharmacist, and specialty providers; access to CHS disease specific management programs;~     dedicated care management services delivered in home and at the clinic; lab and infusion~     services; palliative care consultations when appropriate; and paramedicine for 24 hour~     support. AIRTIGHT (Aiming to Improve Readmissions Through InteGrated Hospital Transitions) is~     a pragmatic, randomized quality improvement evaluation, which seeks to evaluate the effects~     of the role-out of CHS-TS services for patients at high risk for a 30-day readmission.~     AIRTIGHT will test the hypothesis that patients that receive care through CHS-TS will have a~     lower all cause, 30-day readmission rate than patients that receive usual care.~   "
61401|NCT02763189|"~     The purpose of this pilot study is to compare the time it takes to change a breathing tube~     with a new device, performed by two different groups of anesthesiologists; one group will~     study on their own how to change the tube, while the second group will also receive expert~     training, before either group performs the procedure for the very first time. The~     Investigators predict the group who gets expert training will change the tube faster, and~     those investigators also need to learn how much faster, before moving to a larger study.~   "
61402|NCT02763176|"~     This study seeks to assess trends in hCG between the 9th and 12th weeks of gestation. Women~     presenting at prenatal care at the study site who are 70 days gestation or less will be~     offered participation in the study. 75 consenting women will be asked to provide urine for an~     MLPT and to have blood drawn for hCG serum testing at 56-63 days, 64-70 days, and 71-77 days'~     gestation, and 75 consenting women will be asked to provide urine for an MLPT and to have~     blood drawn for hCG serum testing at 64-70 days, 71-77 days, and 78-84 days' gestation.~   "
61403|NCT02763163|"~     These days many studies are conducted testing the symbiosis between the bacteria population~     to the human body's functioning. The research of the connection between the skin condition~     and the bacteria population is in its early stages. There is a characterization of different~     bacteria for different body areas depending on their composition, humidity etc. In addition,~     there are preliminary findings of biological receptors that react to the contact with~     bacteria on the surface of the skin and turn on the immune system, awakening it to cope with~     the new invader. Based on the above information, the investigators hypothesis is that there~     is a connection between the degrees of sun exposure of individuals to the growing of~     beneficial bacteria populations on the surface of the skin. The study will compare between~     the bacteria population on the skin of Israeli subjects, divided to two groups, one with an~     excessive exposure to the sun on a daily basis, (such as agricultural workers, lifeguards,~     construction, etc.), and the other of the office worker who spend most of the day in a closed~     shaded room.~   "
61404|NCT02763150|"~     The overall purpose of this study is to determine the efficacy of a pre-pregnancy lifestyle~     intervention to reduce the recurrence of gestational diabetes mellitus in multiethnic women~     with overweight or obesity.~   "
61405|NCT02763137|"~     This is a phase IIa study to assess the safety, tolerability, plasma pharmacokinetics and~     efficacy of intermittent oral administration of standard levodopa/carbidopa (LD/CD)~     vs.semi-continuous intra-oral administration of levodopa/carbidopa in patients with advanced~     Parkinson's disease (PD) who suffer motor fluctuations.The objective of this study is to~     assess the plasma pharmacokinetics (PK) of continuous intra-oral administration of LD/CD vs.~     intermittent administration of standard oral LD/CD. For purposes of this study continuous~     intra-oral administration of LD/CD is defined as oral administration of LD/CD at 5-10 minute~     intervals.~      Secondary objectives are to assess the safety and tolerability of continuous intra-oral~     administration of LD/CD and the effect on PD motor function of continuous intra-oral~     administration of LD/CD vs. intermittent administration of standard oral LD/CD.~   "
61406|NCT02763124|"~     To assess the effectiveness of the Verion-LenSx guided arcuate incision technique to reduce~     astigmatism in a pseudophakic population.~   "
61407|NCT02763111|"~     BCD-085-3 is a next step in clinical investigation of BCD-085. BCD-085 is a monoclonal~     antibody to interleukin 17. During BCD-085-2 trial patients with active ankylosing~     spondylitis will receive 40, 80 or 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6,~     8, 10, 12. Efficacy and safety parameters will be evaluated.~   "
61421|NCT02762929|"~     A Phase 2, Randomized, Controlled, Multicenter, Evaluation of the Efficacy and Safety of~     Locally Administered HTX-011 for Postoperative Analgesia Following Bunionectomy~   "
61504|NCT02761850|"~     The purpose of prospective cohort study is to describe the developmental profile of~     refraction change in a large cohort of Chinese CC patients. The decisive factors to the range~     of myopic shift in unilateral CC appeared to be different from that in bilateral CC,~     indicating dramatic differences in the etiopathogenesis and refractive prognosis between~     bilateral and unilateral CC.~   "
61508|NCT02761798|"~     This observational study aims to validate the use of a tablet based audiometer to provide an~     accurate, efficient, and cost-effective means for diagnosis of hearing conditions in~     controlled and uncontrolled environments in adult and elderly populations.~   "
61408|NCT02763098|"~     Effects of different doses of remifentanil on hemodynamic response to anesthesia induction in~     elderly patients ABSTRACT OBJECTİVE: The investigators compared the effects of three~     different doses of remifentanil infusion, which have been performed for the induction of~     anesthesia in elder patients, on cardiovascular response.~      PATIENTS AND METHODS: The present study was designed as a randomized, prospective and~     double-blind study. A total of 90 ASA I-II patients over the age of 65 years were enrolled~     and each group consisted of 30 subjects. The patients were randomly (by lot) assigned to~     receive one of the three doses of remifentanil infusion (0.1, 0.2 or 0.3 µg/kg/min) for two~     minutes. Subsequently, 0.5 mg/kg propofol was administered via IV route and, 0.5 mg/kg~     rocuronium was administered via IV route at the time eyelash reflex disappeared. Intubation~     was performed after two minutes. After recording baseline values of heart rate (HR), systolic~     arterial pressure (SBP), diastolic arterial pressure (DBP) and mean arterial pressure (MAP),~     these values were recorded at the 1st, 2nd, 3rd, 4th and 5th minutes of induction.~   "
61409|NCT02763085|"~     Evaluation of a new basic filling restorative material.~      In contemporary dentistry, clinicians have essentially three types of material choices for~     direct restorations: amalgam, resin composite, and glass ionomer restoratives.~      Due to the toxicity of mercury and the subsequent environmental problems, the search for~     alternatives continues and search into new composite restorative materials intensifies.~     Recognized disadvantages of tooth colored resin based restorative materials are as~     polymerization shrinkage, postoperative sensitivity and technical procedure complexity.~     Higher rates of occlusal wear and lower toughness are disadvantages of glass ionomer~     restoratives.~      Therefore, alternative materials are being developed to compensate the disadvantages of~     current contemporary tooth coloured restorative materials. Nevertheless, the search for~     simplification for restoring missing dental tissues introduced the basic filling concept.~      This project aims to study the clinical performance of this new basic filling restorative~     material for Class I and Class II cavities. 80 patients are recruited to the project which is~     carried out at the School of dentistry, Istanbul Medipol University, Turkey.~   "
61410|NCT02763072|"~     The purpose of this study is to evaluate the effectiveness and safety in a clinic setting of~     two laser systems for improvement of lentigines on the hands.~   "
61411|NCT02763059|"~     Background and aim: Postoperative pain is an adverse effect of oral surgeries and may~     therefore be prevented or minimized. This study compares the efficacy of preemptive ibuprofen~     and dexamethasone protocols in pain prevention and control after surgical implant placement.~      Methods: For this prospective, double-masked, parallel-group, placebo-controlled, randomized~     clinical trial, 117 dental implants were placed. The groups received three different~     protocols 1 hour before surgery:~        1. 600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose);~        2. 4 mg dexamethasone (and another 4 mg 6 hours after the first dose) or~        3. placebo.~      Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to~     take it if necessary. Pain intensity was evaluated by a 101-point numeric rate scale and~     visual analogue scale, additionally discomfort was evaluated using a four-point verbal rate~     scale, hourly for the first 8 hours after surgery and three times a day on the following 3~     days.~   "
61412|NCT02763046|"~     The current study will assess the clinical Assessment of SpondyloArthritis international~     Society (ASAS) 20 response to Secukinumab and evaluate to which extent concomitant~     nonsteroidal anti-inflammatory drug (NSAID) treatment can be reduced in patients treated with~     Secukinumab or placebo following an initial run-in phase of stable NSAID therapy. In case of~     a positive outcome concerning the NSAID reduction this study could trigger the development of~     a guidance concerning NSAID reduction applicable for all Ankylosing Spondylitis (AS) patients~     starting a biologic treatment.~   "
61413|NCT02763033|"~     Investigators are evaluating the feasibility, safety and early efficacy of administering a~     commercially available dietary supplement containing potato-based resistant starch to~     subjects undergoing allogeneic SCT (stem cell transplant). The intervention will begin~     immediately prior to the conditioning phase and continue through day 100. Investigators~     hypothesize that short term administration of a resistant starch is capable of increasing~     levels of butyrate within the intestine that will reduce rates of acute GVHD~     (Graft-Versus-Host Disease).~   "
61414|NCT02763020|"~     Consuming plant chemicals (e.g., polyphenols) may have beneficial effects on human health~     that, if confirmed, may warrant inclusion in combat rations. Ration developers would like to~     determine whether the fortification of a high sugar food item with a polyphenol-rich~     freeze-dried fruit and/or a fruit extract improves blood sugar response and promotes other~     positive physiological changes (e.g., satiety) in a dose-response manner. This study will~     test four different types of snack bar with various polyphenol doses, and compare blood~     response to a snack bar without polyphenols.~   "
61415|NCT02763007|"~     Double blind, three arm, comparative intervention trial for 24 weeks(PEAK study) with open~     label extension trial for 28 weeks followed by 2 year observational study.~   "
61416|NCT02762994|"~     BCD-085-2 is a next step in clinical investigation of BCD-085. BCD-085 is a monoclonal~     antibody to interleukin 17. During BCD-085-2 trial patients with moderate to severe plaque~     psoriasis, in whom poor response to previous treatment including UV-therapy and biologic~     drugs was registered, will receive 40, 80 or 120 mg of BCD-085 subcutaneously at weeks 0, 1,~     2, 4, 6, 8, 10. Efficacy and safety parameters will be evaluated.~   "
61417|NCT02762981|"~     The purpose of this study is to assess the safety of the combination of CORT125134, a novel~     glucocorticoid receptor (GR) antagonist, and nab- paclitaxel in patients with solid tumors~     and to determine the preliminary efficacy of the combination of CORT125134 and~     nab-paclitaxel. The structure for the study is a single arm, non-randomized, open- label,~     multicenter trial with no control group.~   "
61418|NCT02762968|"~     The study will determine whether acute ingestion of a probiotic combined with~     beta-hydroxy-beta-methylbutyrate (HMB) can enhance immune and digestive function in soldiers~     during 8-weeks of advanced infantry training.~   "
61419|NCT02762955|"~     CALYPSO clinical study is a phase 3 study which is carried out to establish the efficacy,~     safety and pharmacokinetic equivalence of BCD-055 (adalimumab, manufactured by JSC BIOCAD,~     Russia) and Humira® when used in patients with moderate to severe plaque psoriasis.~   "
61420|NCT02762942|"~     Demonstrate that with concomitant and synchronous use of supracervical balloon and vaginal~     misoprostol for induction of labour, vaginal delivery is achieved in less time compared with~     vaginal misoprostol alone.~   "
61422|NCT02762916|"~     The current increase in chronic diseases calls for changes to the health system. It is~     necessary to promote expert patient in chronic disease. The expansion of new technologies~     gives us new tools to face new challenges, providing efficiency, expertise and autonomy. The~     characteristics of peripheral arterial disease make possible to promote expert patient and~     the self-management. In order to bring these concepts together the telemedicine program was~     created to promote expert patient for increasing the quality of life and satisfaction of~     patients and improving the efficiency of the health system.~      Methods: Randomized clinical trial on patients with peripheral arterial disease in~     intermittent claudication grade. They were randomized into two groups: intervention arm (IA)~     using CONTECI program for self-managing and control arm (CA), followed as usual vascular~     visits.~   "
61423|NCT02762903|"~     The primary objective of this study is to assess the clinical effectiveness of two different~     techniques used for subscapularis tendon repair during total shoulder replacement. The~     investigators hypothesize that participants who receive a newer repair technique called a~     lesser tuberosity osteotomy will have lower rates of postoperative subscapularis muscle~     dysfunction and rupture as compared to those who receive the traditional tenotomy repair.~   "
61424|NCT02762890|"~     The purpose of this study is to investigate and compare the postoperative quality of recovery~     between the deep neuromuscular blockade and moderate neuromuscular blockade during robotic~     gastrectomy.~   "
61425|NCT02762877|"~     A study to determine the concordance of key actionable genomic alterations as assessed in~     tumor tissue and plasma from patients with non small cell lung carcinoma (NSCLC)~   "
61426|NCT02762864|"~     To compare the effect of PRU(platelet (P2Y12) reaction units)-guided treatment on the change~     in~        1. time of initial leg pain and time of termination of exercise test by pain, evaluated on~          the graded stationary bicycle test,~        2. the lower limb perfusion by using MRI blood oxygenation-level dependent (BOLD) and~          dynamic contrast enhancement sequences and measures the extracellular volume fraction~          (ECV) as an indicator of fibrosis severity in calf muscles, from one to 52 weeks~          post-revascularization in patients with peripheral artery disease who have undergone~          endovascular revascularization -/+ bypass surgery for moderate to severe claudication or~          ischemic rest pain.~   "
61427|NCT02762851|"~     A multi-centre, randomized, placebo controlled, trial. Participants at high-risk for vascular~     events from the network of INTER- CHF will be randomized to inactivated influenza vaccine or~     placebo and followed prospectively over three influenza seasons. 5,000 participants will be~     enrolled prior to influenza season, randomized to either influenza vaccine or saline placebo,~     either of which they will receive annually for three years and then followed over each of the~     influenza seasons.~   "
61428|NCT02762838|"~     BCD-055-3 is international multi-center comparative double-blind randomized clinical trial of~     efficacy and safety of BCD-055 (JSC BIOCAD, Russia) and Remicade® in combination with~     methotrexate in patients with active rheumatoid arthritis.~   "
61429|NCT02762825|"~     Patients with HFpEF suffer from exercise intolerance, increased risk for hospitalization and~     mortality, and poor QOL. Unlike patients with HFrEF, no drug or device therapies appear to be~     consistently beneficial in treating these problems. However, increasing evidence suggests~     that exercise training is effective for both partially reversing exercise intolerance and~     improving quality of life in these patients. Most such trials to date have been conducted in~     controlled research setting, versus integrating these patients in to a standard CR program.~     Also, since functional capacity is related to outcomes in these patients, exercise strategies~     aimed at further improving fitness are warranted. One such strategy is using higher intensity~     interval training (HIIT) in the CR setting, a strategy shown to be effective in patients with~     other types of CVD. This project is designed to test the feasibility of incorporating these~     patients into the CR setting, and training them using a methodology (i.e., HIIT) already~     shown to yield (in other patients with CVD) greater gains in fitness when compared to what~     was achieved using standard MCT alone.~   "
61430|NCT02762812|"~     BCD-055-2 is international multi-center comparative double-blind randomized clinical trial to~     evaluate efficacy and safety of BCD-055 (JSC BIOCAD, Russia) and Remicade® in patients with~     ankylosing spondylitis.~      BCD-055 is biosimilar of infliximab (JSC BIOCAD, Russia)~   "
61431|NCT02762799|"~     BCD-002-1 is 1 phase clinical trial to evaluate pharmacokinetics, pharmacodynamics and safety~     of single-injection of Leucostim® to healthy volunteers compared to Neupogen®~   "
61432|NCT02762786|"~     This study aims to examine the effectiveness of musical training in in improving the~     psychological well-being, in particular their self-esteem, depression, happiness and quality~     of life of children from low income families.Half of the participants will receive weekly~     one-hour lessons on musical training for 12 weeks, while the other half are the placebo~     controls.~   "
61433|NCT02762773|"~     The purpose of this study is to evaluate the effect of non-dissecting the inferior rectus~     sheath during primary cesarean delivery on post-operative hemoglobin and post-operative pain~     control as measured by VAS score and opioid anesthesia use in the first 72 hours post-op.~   "
61434|NCT02762760|"~     This study will evaluate the safety of an intra-articular injection of AMPION™ in adults with~     pain due to osteoarthritis of the basal thumb joint.~   "
61435|NCT02762747|"~     This is a RCT on drain versus no drain after laparoscopic totally extra-peritoneal~     hernioplasty. We will assess the difference in seroma formation after surgery in 2 two groups~     by an independent assessor clinically and radiologist to document the size of seroma after~     surgery. Other secondary outcomes will be measured including post-operative pain, discomfort,~     analgesic used, patient satisfaction, recurrence of hernia, wound infection, etc.~   "
61465|NCT02762357|"~     The aim of this study is to show that the performance of Novosyn® Quick suture material is~     comparable with other suture material used for episiotomy. In order to show that, various~     safety and efficacy parameters have been selected. The outcome regarding these parameters~     will be evaluated by a quantitative summary of the available clinical data from the~     literature. Study population consists of women with a spontaneous vaginal delivery who~     required perineal repair due to an episiotomy.~   "
61505|NCT02761837|"~     The Breathe Well Study is a pragmatic, controlled trial to assess the effectiveness,~     cost-effectiveness, and implementation of the Breathe Well intervention, which combines~     evidence-based EHR and interactive behavior-change technologies (IBCT) and team-based care to~     improve asthma outcomes.~   "
61436|NCT02762734|"~     MEDIACONNEX study propose a new way of connectedness for adolescents after a suicide attempt:~     it is based on the sending of SMS (or mail or other new media), over a period of 6 months~     after their suicide attempt (SA), in order to allow them to recourse to the care more easily~     and so to limit the risk of suicidal recurrence. The MEDIACONNEX study will be a multicenter~     controlled randomized trial (East of France) and there is a funding from the Hospital. The~     proposal trial will test the hypothesis that adolescent suicide attempters who are receiving~     SMS (or mail or other new media) from the unit of care in addition to the usual care will do~     less SA recurrence, than those who are receiving the usual care.~      The primary objective is to determine whether the use of SMS (or mail or other new media) to~     keep in touch with adolescent suicide attempters in addition to the usual care, compare to~     usual care, will reduce the delay of recurrence of suicide attempt during 6 months after the~     SA.~   "
61437|NCT02762721|"~     The primary objective of this study is to estimate the frequency of FGFR2 fusions in archived~     intrahepatic cholangiocarcinoma (iCCA) or mixed hepatocellular-cholangiocarcinoma (HCC-CCA)~     tumor samples~   "
61438|NCT02762708|"~     What are the benefits of undergoing Roux-en-Y gastric bypass surgery in improving type 2~     diabetes outside of weight loss alone?~   "
61439|NCT02762695|"~     The purpose of this study is to evaluate whether a new model of health care for chronic~     patients, based on Case Management and guided by a nurse which targets the patient´s risk, is~     more effective than usual care at Primary Health care in Chile. Additionally, this~     intervention would provide a better quality of care and a more efficient health provision.~   "
61440|NCT02762682|"~     PRIMARY OBJECTIVES~      • To describe the vitamin B12 status in children with infantile tremor syndrome(ITS) and Pre~     ITS~      SECONDARY OBJECTIVES~        -  To study the vitamin B12 status in mothers of children with infantile tremor syndrome~          (ITS) and Pre ITS~        -  To study the blood levels of folate in children with infantile tremor syndrome (includes~          Pre ITS) and their mothers.~   "
61441|NCT02762669|"~     Postpartum hemorrhage (PPH) is a leading cause of maternal mortality and morbidity worldwide,~     and is caused most commonly by poor uterine muscle contraction after delivery of the baby and~     placenta. The first line agent used in the prevention and treatment of PPH is oxytocin, which~     acts by binding with the oxytocin receptor (OTR) found on myometrial cells to cause uterine~     contraction.~      Oxytocin is also used for the augmentation of labor when spontaneous labor has been deemed~     ineffective. It is administered intravenously at progressively higher doses, until effective~     contractions are achieved and vaginal delivery results. However, if augmentation is~     determined to have failed, a Cesarean delivery (CD) is performed.~      One of the potential problems with oxytocin use during delivery is that it loses its~     effectiveness if the uterus has previously been pre-exposed to its high doses and/or for a~     prolonged duration during labor. This phenomenon is termed OTR desensitization, and can~     result in the attenuation of myometrial contractility induced by subsequent oxytocin~     administration, as well as PPH due to poor uterine tone. Furthermore, oxytocin can produce~     potentially fatal maternal hemodynamic adverse effects when administered at high doses, so it~     is advantageous to be able to use as low a dose as possible to obtain good uterine muscle~     tone.~      The objective of this study is to get a better understanding of the signaling pathways~     governing desensitization, resensitization and contractility in pregnant human myometrium.~     The investigators wish to investigate the effects of increasing recovery period on the~     expression patterns of the OTR and its signaling pathways in desensitized pregnant human~     myometrium.~      This study will help shed light on the molecular mechanisms responsible for desensitization~     and oxytocin-induced myometrial contractility, and will provide some insight into potential~     therapeutic targets to reduce the incidence of PPH and complications associated with using~     increasing concentrations of oxytocin.~      The hypothesis is that the expression and phosphorylation patterns of the OTR and downstream~     proteins will be altered in desensitized myometrium, and that these patterns will change with~     increasing rest periods and re-exposure to oxytocin.~   "
61442|NCT02762656|"~     The purpose of this study is to evaluate the effectiveness of perioperative Lidocaine~     intravenous infusion in reducing postoperative pain for spine surgery patients.~   "
61443|NCT02762643|"~     A randomized, open-label, crossover, Phase I clinical trial to compare the pharmacokinetics~     of DP-R213 (Raloxifenel and Cholecaliferol fixed dose combinations) in comparison to each~     component administered alone in healthy male volunteers.~   "
61444|NCT02762630|"~     Healthy volunteers will have a weight bearing cone beam CT scan of their knee to assess~     normal alignment of the knee joint~   "
61445|NCT02762617|"~     This prospective, two-site, two-arm, randomized, single-blind, placebo-controlled trial will~     examine the safety and pharmacokinetics (PK) of a polyurethane tenofovir disoproxil fumarate~     (TDF) vaginal ring when used continuously for 84 consecutive days by sexually active women.~      The primary objective is to assess the safety of TDF vaginal rings when used continuously for~     84 days by healthy, HIV-uninfected, sexually active women, as compared with a placebo vaginal~     ring.~   "
61446|NCT02762604|"~     The investigators propose a single-blind randomized clinical trial to determine if seniors~     show improved mobility (walking speed) and cognition following motor imagery (imagined~     walking) training. They hypothesize that imagined walking can be used as a rehabilitative~     tool for improving walking speed and cognition in the elderly, because it engages and~     strengthens similar neural systems as actual walking and cognition.~   "
61447|NCT02762591|"~     The purpose of this program is to provide patients with PDP access to pimavanserin until the~     product receives marketing approval from the FDA and is commercially available.~   "
61448|NCT02762578|"~     This trial is conducted in Asia. The aim of this trial is to compare efficacy and safety of~     insulin degludec/insulin aspart and BIAsp 30 in subjects with type 2 diabetes.~   "
61449|NCT02762565|"~     Early detection of breast cancer improves the survival rate and makes treatment less costly.~     This study would measure the accuracy a low-cost hand-held commercially viable device, iBE,~     for the detection of clinically relevant findings in the breast using the results of current~     mammography as a comparison. This research will have no impact on clinical decision making.~   "
61450|NCT02762552|"~     In acute ischemic stroke, the identification of an etiology is of major importance to prevent~     recurrence by providing the best treatment. Because of numerous possible underlying~     etiologies, the etiological work-up of ischemic stroke includes a wide range of diagnostic~     tests, which can be invasive, long and expensive. Moreover, many patients receive a diagnosis~     of undetermined stroke even after all available diagnosis tests are done, precluding optimal~     treatment.~   "
61466|NCT02762344|"~     Observational cohort registry: prospective, multicenter independent evaluation of patients~     who undergo coronary angiography and/or PCI via radial artery. The purpose of this registry~     is to set the incidence of RAO according to ACT values, considered both as continuous and~     ordinal variable and its determinants. Coronary angiography and PCI will be performed~     according to usual practice.~   "
61536|NCT02761421|"~     To investigate the motor development, motor function and electrodiagnostics presentation in~     IOPD under ERT.~   "
61451|NCT02762539|"~     Traumatic brain injury (TBI) is major health problem that stands as a significant cause of~     death and permanent disability. TBI is considered as global public health epidemic. On~     pathophysiologic basis, TBI is described as occurring in two phases, primary and secondary.~     Once a primary insult occurs like trauma or ischemia, the secondary injury begins though main~     four mechanisms; ischemia, brain edema, axonal injury and neuro-inflammation. Omega-3 PUFAs~     (Polyunsaturated fatty acids) are postulated to have neuroregenerative properties with the~     ability to impact all four main mechanisms of the secondary injury Patients will be allocated~     into one of two groups through a random table generation; Control group in which patients~     will follow our local protocol for TBI management without SMOF-lipid infusion. SMOF-lipid~     group in which patients will receive 0.5 g/Kg SMOF lipid 10% emulsion (Lipid emulsion for~     intravenous nutrition containing; 6% soybean oil / 6% medium chain triglycerides / 5% olive~     oil / 3%fish oil) daily over 12 hours starting once admitted to ICU for 7 days~   "
61452|NCT02762526|"~     Background: The lipoabdominoplasty can lead to respiratory complications in the postoperative~     period becoming critical early clinical and functional evaluation of respiratory muscles,~     seeking to direct a more effective treatment, which can result in shorter hospital stays and~     lower spending on health in patients undergoing such procedures. Objective: To evaluate the~     correlation of regional distribution of ventilation system with thoracoabdominal~     diaphragmatic mobility in women undergoing surgery lipoabdominoplasty comparing preoperative,~     10 ° and 30 ° DPO DPO. Methods: This is a prospective cohort study, which will be evaluated~     30 women aged 25 to 55 years undergoing lipoabdominoplasty surgery without respiratory or~     prior cardiac comorbidities and body mass index (BMI) ≤ 30 kg / cm2. women smokers are~     deleted and / or a history of smoking more than 10 years and unable to understand the~     commands to perform the proposed methods. For evaluation of diaphragmatic mobility will be~     used high-resolution ultrasound with convex 3.5 MHz transducer. The evaluation of the~     regional distribution of ventilation thoracoabdominal system will be made using the~     optoelectronic plethysmograph (POE). The strength of the inspiratory and expiratory muscles~     is measured through a digital manometer connected to a nozzle with an orifice of 2 mm to~     reduce the closing pressure of the glottis. A portable spirometer is used for assessment of~     pulmonary function and evaluation of dyspnea will be used modified Borg scale. The data will~     be evaluated in the preoperative period, 10 days and 30 days postoperatively. Hypotheses:~     Patients undergoing surgery lipoabdominoplasty have decreased diaphragmatic mobility,~     strength and respiratory function, in addition to presenting changes in the pattern of~     regional ventilation distribution in torocoabdominal system in the postoperative period when~     compared to the preconditions surgery.~   "
61453|NCT02762513|"~     This study will be a prospective, single-institution, single-arm phase II study of Axitinib~     in patients with unresectable recurrent and metastatic head and neck squamous cell carcinoma.~     The subjects will be started on treatment with 5 mg of Axitinib twice a day continuously,~     with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2~     or worse toxicities. This will be followed by clinical and/or radiologic response assessment~     after 8 weeks and subsequently every 2 months until disease progression or intolerable~     toxicity.~   "
61454|NCT02762500|"~     The purpose of the study is to evaluate the efficacy and safety of LYC-30937-EC given orally~     once daily in subjects with active ulcerative colitis (UC) defined as a total Mayo score~     (TMS) of 4-11 inclusive, with an endoscopic score of ≥ 2 and a rectal bleeding score of ≥ 1~     at screening.~   "
61455|NCT02762487|"~     The purpose of this study is to evaluate the LINX device in patients who have previously~     undergone laparoscopic sleeve gastrectomy (LSG) for obesity and have chronic gastroesophageal~     reflux disease (GERD). The study will monitor safety and changes in reflux symptoms.~   "
61456|NCT02762474|"~     This trial is going to evaluate the efficacy and safety of IMRT / nab-TP chemotherapy for~     unresectable esophageal cancer, and to investigate the optimal concurrent chemotherapy~     regimen for local advanced and unresectable esophageal cancer patients.~   "
61457|NCT02762461|"~     This project will investigate worsening of symptoms in endometriosis patients undergoing~     artificial reproductive techniques (ART). The study compares patients with peritoneal/ovarian~     and deep infiltrating endometriosis to relevant reference groups. Symptoms are monitored with~     a questionnaire with the categories quality of life, pain and bowel habits. The EHP-30®~     questionnaire is included in the questionnaire.~   "
61458|NCT02762448|"~     Interferon-free Antiviral Treatment of HCV-Positive Genotype 1b Related Indolent non-Hodgkin~     Lymphomas Patients Using Daclatasvir and Asunaprevir: A Pilot Study~   "
61459|NCT02762435|"~     After written informed consent eligible hospitalized patients will be randomized to one of 3~     arms (1:1:1:): control, sham, accupressure (3 points on the hand and wrist three times per~     day). Quality of recovery and other measures of patient satisfaction will be recorded.~   "
61460|NCT02762422|"~     Blood donation has been proposed to be associated with reduced risk of cardiovascular~     disease, but the effects of phlebotomy on vascular function in human subjects have not been~     well characterized. A prospective randomized double-blind study was undertaken to determine~     the effects of iron loss and red blood cell loss induced by serial phlebotomy on vascular~     endothelial function in the brachial artery.~   "
61461|NCT02762409|"~     Demonstrate that the IPREA3 program (Study: Impact of Multicomponent Intervention to Reduce~     Perceived Discomforts of the patients in intensive care) reducing discomforts perceived by~     the patients of intensive care, implemented at the level of the whole intensive care unit,~     reduce the incidence of the depressive symptoms one year after intensive care exit.~   "
61462|NCT02762396|"~     NOR-SYS II is designed for finding the cause of acute ischemic stroke lesions in Young~     adults, age 15 to 49 years. Risk factors, arterial wall changes by intima-media thickness and~     plaques and consequences of stroke are examined by standardized diagnostics.~   "
61463|NCT02762383|"~     This is an uncontrolled, open-label, Phase III trial of peginterferon alfa-2a (Pegasys) in~     participants coinfected with human immunodeficiency virus (HIV) and hepatitis C virus (HCV).~     Participants with HIV/HCV who do not show negative or reduced HCV ribonucleic acid (RNA)~     after at least 12 weeks of treatment with peginterferon alfa-2a plus ribavirin will receive a~     low dose of peginterferon alfa-2a for 18 months. The primary objective is to evaluate safety~     and tolerability. Secondary objectives are to evaluate histological, virological, and~     biochemical effects.~   "
61464|NCT02762370|"~     The purpose of this study was to compare the effects of FX006 and Triamcinolone Acetonide~     Injectable Suspension, United States Pharmacopeia (USP) (referred to as TCA IR in the~     protocol) on blood glucose (BG) in patients with osteoarthritis (OA) of the knee and Type 2~     diabetes mellitus (DM).~   "
61489|NCT02762045|"~     This is a randomized, double-blind placebo-controlled dose-escalation clinical trial to~     evaluate the safety and the immunogenicity of Adenoviral vector 5 HIV-1 vaccines in subjects~     receiving stable highly active antiretroviral therapy(HAART) .~   "
61467|NCT02762331|"~     Coronary artery bypass grafting (CABG) is the most common procedure performed by cardiac~     surgeons. Post-operative atrial fibrillation (AF) is the most common adverse event following~     CABG, experienced in 20-50% of patients; the highest incidence of AF occurs by the third~     post-operative day. Reduction of AF by various drugs is moderately effective, but involves~     either rate control with beta blockers or rate conversion with amiodarone after the~     myocardial damage processes initiating AF have already occurred. Decreasing the incidence of~     post-operative AF, and hence the morbidity and mortality of high-risk CABG patients, could be~     more fruitfully approached by targeting the upstream combined processes of inflammation and~     coagulation activation induced by the surgical insult and associated ischemia-reperfusion~     (I/R). We propose that cell damage induced by oxidative stress and I/R injury could be~     prevented and/or inhibited by antioxidant supplementation. Specifically the investigators~     hypothesize that high-dose intravenous (IV) vitamin C supplementation will ameliorate ROS and~     therefore damp down upstream inflammatory processes, leading to a reduction of downstream~     adverse events with demonstrable links to inflammation processes, such as AF.~   "
61468|NCT02762318|"~     Identify novel genetic variants causing skeletal dysplasia in Qatari populations and to~     additionally develop an understanding of how those variants influence skeletal biology at a~     molecular and cellular level.~   "
61469|NCT02762305|"~     The hypothesis of this study is that participation in the Retired and Senior Volunteer~     Program (RSVP) Bone Builders program 1 hour, twice per week, for a minimum of 12 weeks will~     result in significant positive changes to the health status of older adult participants~     compared to controls including increased leg strength, improved balance, improved balance~     confidence, increased walking speed, decreased fall risk, and increased life satisfaction.~   "
61470|NCT02762292|"~     Introduction In patients assisted by mechanical ventilation, the Work Of Breathing (WOB) is~     shared between the patient and the ventilator. During weaning from mechanical ventilation,~     the WOB performed by the patient must be adequate and efficient to sustain spontaneous~     ventilation after extubation. The monitoring of WOB during weaning might allow a better~     management of the weaning process. Esophageal pressure (PES) is the reference technique to~     measure WOB but alternate tools have been proposed. The main hypothesis is that Indirect~     Calorimetry (IC) is valid to track the changes in energy expenditure due to the changes in~     WOB in mechanically ventilated children during weaning from mechanical ventilation. The~     primary objective of this study is to assess the validity of IC method for the WOB assessment~     when compared to PES measurement and Electrical Activity of the diaphragm (EAdi) during a~     spontaneous breathing trial (SBT) in continuous positive airway pressure, which is a routine~     extubation readiness test which generally induces an increase in WOB.~      Methods This is a prospective single center study. All intubated and mechanically ventilated~     children >1 months and <18 years old, hospitalized in the pediatric intensive care unit will~     be eligible.~      Simultaneous recordings of Energy Expenditure, PES and EAdi will be performed during 3 steps:~     before, during and after the SBT. Then outcome of patients will be collected.~      The investigators plan to study a sample of 15 patients to be representative.~      Relevance to the importance of child health in Canada The investigators expect that the~     IC-based less invasive method will provide an accurate estimation of WOB assessment. Once~     this tool is validated, the interest of IC to (i) early detect an increase in WOB during~     mechanical ventilation in children, (ii) to assess the ability to extubate them and (iii) to~     optimize nutritional support will be assessed in future studies.~   "
61471|NCT02762279|"~     Background During ventilatory assistance, optimization of settings is critical to allow a~     personalized support and avoid over- or under-assistance. But little data are available in~     clinical practice to guide the adjustment of the support. In adults, esophageal pressure~     (PES) has been shown to be a reliable surrogate of pleural pressure (PPL) and clinical~     studies suggest that PES may be useful to guide the management of mechanical ventilation. In~     children, the PES measurement could have similar potential benefits, but beforehand the~     reliability of PES to estimate PPL needs to be assessed.~      Objective The primary objective of this study is to validate the reliability of PES directly~     monitored using a miniature catheter tip pressure transducer (Gaeltec® system) to estimate~     PPL, when compared to a gold standard, i.e the direct PPL measurement in situ.~      Method This is a prospective single center study. Children <18 years old, hospitalized in the~     pediatric intensive care unit, requiring invasive ventilation and with at least one chest~     tube will be included.~      Protocol A pressure transducer will be connected to the existing chest-tube and PES (measured~     by Gaeltec® and feeding tube), PPL, PAW, respiratory volume and flow will be simultaneously~     recorded.~      Expected results We expect that the PES-based methods will provide an accurate estimation of~     PPL. Once this tool validated, PES could be helpful to optimize mechanical ventilation in~     children, and further interventional trials would be warranted to evaluate if its use could~     allow a reduction of the ventilation support duration.~   "
61472|NCT02762266|"~     This randomized phase III trial studies how well transarterial chemoembolization (TACE) works~     compared to stereotactic body radiation therapy (SBRT) or stereotactic ablative radiation~     therapy (SABR) in patients with liver cancer that remain after attempts to remove the cancer~     have been made (residual) or has come back (recurrent). TACE is a minimally invasive,~     image-guided treatment procedure that uses a catheter to deliver both chemotherapy medication~     and embolization materials into the blood vessels that lead to the tumors. SBRT or SABR may~     be able to send radiation directly to the tumor and cause less damage to normal liver tissue.~     It is not yet known whether TACE is more effective than SBRT or SABR in treating patients~     with persistent or recurrent liver cancer who have undergone initial TACE.~   "
61473|NCT02762253|"~     This study is being conducted to assess the safety and effectiveness of photochemically~     induced collagen cross- linking (CCL) at irradiance of 18mW/cm2 in eyes with Keratoconus and~     Ecstasia.~   "
61474|NCT02762240|"~     Accreditation is used increasingly in health systems worldwide. However, there is a lack of~     evidence of the effectiveness of accreditation. The overall aim of this study is to evaluate~     the effectiveness of a mandatory accreditation in general practice.~   "
61475|NCT02762227|"~     This prospective cohort study is designed to investigate and to compare the diagnostic~     performance of contrast-enhanced ultrasonography (CEUS) and multidetector computed tomography~     (CT) for gallbladder cholesterol polyps, adenoma and gallbladder cancer.~   "
61476|NCT02762214|"~     Prospective multicentric randomized trial to evaluate the role of uterine manipulator on~     laparoscopic/robotic total hysterectomy for the treatment of early stage G1 - G2 endometrial~     cancer (International Federation of Gynecology and Obstetrics - FIGO stages IA-IB).~   "
61477|NCT02762201|"~     This study aims to compare the therapeutic efficiency of implant-secured removable partial~     denture (PASI) with the therapeutic efficiency of the metalic standard removable partial~     denture (PAC) in the treatment of intermediate extended-gap (4 adjacent teeth). The~     therapeutic efficiency will be assessed by the 5 years-prosthetic success rate.~   "
61478|NCT02762188|"~     Age-Related Macular Degeneration (ARMD) is the most common cause of blindness in the adult~     population of the Western World. It affects the macula - the region of the retina most rich~     in photoreceptors and responsible for central vision. The ethiology of ARMD remains poorly~     understood. Population-based studies have demonstrated a complex ethiology, with~     contributions from a combination of genetic and environmental factors.~      Two major forms of ARMD are clinically distinguishable: the dry and wet form. The latter~     represents the more aggressive clinical subgroup, and is characterized by the abnormal growth~     of new blood vessels (neovascularization) under the macula, thus leading to the accumulation~     of fluid under the retina, bleeding, progression to fibrosis, and finally loss of central~     vision.~      The pathogenesis of this neovascularization is not fully understood, although the VEGF~     pathway is well known to be involved in angiogenesis and was implicated in the development of~     the new vessels under the macula. The VEGFs are the most specific and potent stimulators of~     the angiogenesis.~      Molecules that bind and inactivate the VEGF have been developed for the treatment of ARMD and~     they are applied in ARMD clinic through intra vitreal injections.The difference seen in~     response to anti VEGF treatment for ARMD between the patients is suggestive for the presence~     of factors influencing the effect of the drug. Some of these could be genetic variants within~     genes involved in ARMD pathogenesis or VEGF pathway. Few associations with markers within~     genes previously found to be related with the pathogenesis of ARMD have been found. It~     remains unknown whether variants involved in the anti VEGF treatment response could influence~     the therapeutic outcome.~      The purpose of this trial is to evaluate the association between a panel of selected~     polymorphic markers in the VEGF pathway and the response to therapy with anti VEGF antibody~     for ARMD. The hypothesis is that the individual genotype influences the response to the anti~     VEGF. This can lead to identification of genetic biomarkers allowing treatment~     individualization and optimization of the visual outcomes.~   "
61479|NCT02762175|"~     Background~      Obstructive sleep apnea syndrome (OSAS) is a sleep-related breathing disorder characterized~     by intense snoring and repetitive complete or partial obstructions of the upper airway during~     sleep together with daytime sleepiness. Several non-invasive therapeutical options exist,~     however, they do not offer a permanent improvement. Maxillomandibular advancement (MMA)~     surgery is a procedure which changes the upper airway in a permanent way.~      Objectives~      The investigators aim to develop a prospective database registering 3D volumetric changes of~     the upper airway and its anatomic subregions, the apnea-hypopnea index (AHI) and quality of~     life (QOL) of all consecutive patients eligible for MMA, performed by Dr. Neyt. Patient~     demographics, detailed virtual cone-beam computed tomography (CBCT) planning parameters,~     orthognathic surgery, polysomnographic and QOL data are being collected during consecutive~     visits within the framework of routine practice.~      Design~      A prospective, observational cohort study~      Study center~      General Hospital (AZ) Sint-Jan Brugge-Oostende~      Population~      The investigators would like to include all OSAS patients (AHI ≥ 5) requiring a MMA by Dr.~     Neyt starting from January 2015.~      Endpoints~      The investigators aim to collect data that could provide information about the advantages and~     disadvantages of the routinely performed 3D CBCT preoperative MMA surgery planning for OSAS~     patients, regarding 3D volumetric changes of the upper airway and its anatomic subregions and~     quality of life (QOL) in a subjective manner with the Epworth Sleepiness Scale (ESS) and the~     OSAS questionnaire and in an objective manner with evaluation of the apnea-hypopnea index~     (AHI).~      Duration~      In light of the continuous improvement of patient care, a database will be maintained from~     January 2015 onwards to enable registration of large-scale OSAS patient data.~      Conclusions~      Development of a database registering 3D CBCT planning, polysomnographic data and quality of~     life (QOL) of all consecutive patients eligible for MMA, will provide more information about~     potential patient, virtual planning and surgical factors influencing accuracy of MMA, and the~     associated biological benefits of this procedure on the upper airway volume, the AHI and~     general QOL. Moreover, registration of those results could function as a measurement of~     quality of care, or could be used for sample size calculation for future large multicenter~     prospective trials.~   "
61480|NCT02762162|"~     ONASSIST is a registry of coronary ill patients who have had a functional test measuring~     anti-platelet effect and/or a genetic profile of response to anti-platelet drugs.~   "
61481|NCT02762149|"~     Epidural analgesia is commonly used for labor pain relief due to its safety and~     effectiveness. Despite a very high success rate, the epidural technique remains a somewhat~     blind technique and failures continue to occur. Unfortunately, there are no imaging~     techniques that can be used at the bedside to determine the proper positioning of the~     epidural catheter. The trans-catheter electric stimulation test (TCEST) has been successfully~     used for this purpose. This test is occasionally performed in situations where the immediate~     confirmation of the proper epidural catheter location is deemed necessary. The test helps to~     predict which epidurals might fail so that appropriate measures could be immediately~     implemented.~      There has been one duration of electrical stimulus (0.2 milliseconds) that has been used in~     the majority of studies and in clinical practice. With this duration of stimulation, the vast~     majority of cases show a unilateral motor response of the lower limbs during the TCEST.~     Studies on the stimulation of peripheral nerves (nerves in the arms and legs) have shown that~     an electrical stimulus with a longer duration is able to stimulate nerves which are farther~     away. Since nerves in the epidural space are similar in composition to peripheral nerves, the~     investigators expect to see a higher rate of bilateral response with the longer duration of~     stimulus. The investigators also hope to show that this bilateral response is predictive of a~     better functioning epidural.~      The investigators hypothesize that the incidence of a bilateral response to the TCEST will be~     higher with the 1.0 ms pulse width compared to 0.1 ms pulse width. Furthermore, the~     investigators hypothesize that a bilateral motor response associated with the 1.0 ms pulse~     width will be predictive of symmetry of sensory and motor block and of lower consumption of~     local anesthetic.~   "
61482|NCT02762136|"~     Functional dyspepsia (FD), which is one of the most common gastrointestinal disorders with~     high disease burden. Postprandial distress syndrome (PDS) is a common subtype of FD. Although~     the effectiveness of Chinese herbal formula of Xiang-sha-liu-jun granule (XSLJG) for~     alleviating PDS symptoms has been assessed in previous studies, more convinced evidence of~     randomized placebo-controlled study is needed.~   "
61483|NCT02762123|"~     The study is being conducted to assess the effect of BMS-986142 on the single-dose PK~     parameters of montelukast, flurbiprofen, omeprazole, midazolam, and digoxin, probe drugs for~     (cytochome P450) CYP2C8, CYP2C9, CYP2C19, CYP3A4, and P-glycoprotein (P-gp), respectively.~   "
61484|NCT02762110|"~     Evaluate the feasibility of using a novel imaging test, [18F]ISO-1 PET/CT to image sigma-2~     receptor binding in cancer. Correlate uptake with standard and experimental pathology assays~     of biopsy or surgical tissue. The target population is up to 30 adult patients at least 18~     years, with a known or suspected breast cancer and at least one lesion 1.0 cm in size by at~     least one type of standard imaging.~   "
61485|NCT02762097|"~     Polyps are fleshy outgrowths of the inner lining of the womb which may hinder implantation of~     embryo and lead to subfertility.This study evaluates whether removal of endometrial polyps in~     womb affects chances of pregnancy in women in whom no other causes of subfertility can be~     found. Half of the women would have these polyps removed after their consent and the other~     half who would not consent would not undergo any such intervention~   "
61486|NCT02762084|"~     Multicenter, double-blind, randomized, vehicle-controlled evaluates the efficacy and safety~     of patidegib gel, 2% and 4% in comparison with vehicle in subjects at least 18 years of age~     that meet the diagnostic criteria for basal cell nevus syndrome (BCNS). Subjects will be~     randomized to receive patidegib gel 4%, patidegib gel 2%, or the vehicle gel for a 26 week~     treatment period.~   "
61487|NCT02762071|"~     This study will compare interscalene nerve block versus liposomal bupivacaine (Exparel) for~     pain control after total shoulder replacements. Each method will be assessed in terms of post~     operative pain scores, pain medication consumption, length of stay, complications (nerve~     injuries, hematomas, cardiac/respiratory events) and rate of readmission due to pain. The~     aims of this study will be achieved through a randomized controlled trial and~     cost-effectiveness analysis.~   "
61488|NCT02762058|"~     The goal of this study is to investigate the effects of virtual reality based mirror therapy~     (VMT) on individuals with acquired brain injury when compared to a control group receiving~     traditional mirror therapy (TMT). This is a randomized controlled pilot study in which~     patients with hemiplegia will be assigned to VMT or TMT and the impact on upper extremity~     function will be observed.~   "
61491|NCT02762019|"~     Children with cancer undergoing intensive chemotherapy (CT) regimens experience many side~     effects among which oral mucositis (OM) is one of the most debilitating. Modifications of~     CT's schedule and prolonged hospitalization may be necessary in presence of OM, causing poor~     general conditions and debilitation. Moreover, the use of narcotic analgesics and total~     parenteral nutrition may be required, triggering not only a physical deficit but also an~     economic burden. Despite the frequency and impact of OM among children with cancer, there is~     no consensus on standard therapy for this condition. Previous studies demonstrated that high~     power laser therapy can help the maintenance of nutritional status in patients with OM and~     can remarkably reduce costs/resources needed. Laser therapy has evidence of efficacy in~     reducing symptoms and in preventing the onset of OM in adult cancer patients but only one~     randomized controlled trial, with a limited number of children enrolled, supports its use in~     children for treatment of OM induced by chemotherapy.~      This multicenter double-blind randomized controlled trial evaluates the efficacy of laser for~     treatment of oral mucositis secondary to chemotherapy in children aged 3-17 years.~      The study involves 8 italian hospitals.~   "
61492|NCT02762006|"~     The purpose of this study is to investigate the safety and feasibility of administering~     investigational drugs (meaning not Food and Drug Administration (FDA)-approved for kidney~     cancer) prior to surgical treatment for kidney cancer. The first drug is called MEDI4736, and~     the second drug is called tremelimumab. Both of these drugs work by attaching to certain~     proteins on immune cells with the goal of stimulating an immune response against cancer~     cells. This is a phase 1 trial, with the primary goal of identifying if this treatment is~     safe and possible side effects when given prior to surgery for kidney cancer.~   "
61493|NCT02761993|"~     The purpose of this study is to determine whether ST266 will reduce pocket depth (PD) as an~     adjunctive to scaling and root planing (SRP) in subjects with moderate to severe periodontal~     disease.~   "
61494|NCT02761980|"~     This is a single dose study that will evaluate the efficacy and safety of a Fixed Dose~     Combination Ibuprofen 250 mg/ Acetaminophen 500 mg tablet in healthy male patients with~     fever. Results for the Fixed Dose Combination product will be compared to the individual~     components Ibuprofen 250 mg and Acetaminophen 500 mg and also compared to placebo.~   "
61495|NCT02761967|"~     This study evaluates whether the use of moderate physical exercise character in water is~     beneficial for pregnant women. Half of the participants will carry out moderate physical~     exercise character in water, following the protocol developed specifically for this purpose~     and called SWEP method, while the other group will not perform physical exercise during~     pregnancy.~      Concluded the postpartum period, women perform exercises aimed postpartum recovery. The~     women's group has conducted exercises during pregnancy postpartum recovery made under the~     guidance of LPF method.~   "
61496|NCT02761954|"~     With this study we want to see how the blood flow in the anterior cerebral artery (ACA) and~     the basilar artery (BA) after the caudal block changes.~   "
61497|NCT02761941|"~     The aim of this study is to investigate the clinical significance of high INR (International~     Normalized Ratio) values (>9) in VKA (vitamin K antagonist) treated patients with atrial~     fibrillation. The clinical characteristics of these patients will be studied as well as the~     clinical presentation. Factors influencing on high INR values will be recorded and the aim is~     to seek out patients who have elevated risk of bleeding complications.~   "
61498|NCT02761928|"~     Observational study of axial spine pain and hyperflexibility. Patients will receive physical~     exam maneuvers (traditional straight leg raise, FABER, facet loading as well as Beighton's~     hypermobility score) and blood / urine / saliva collection. They will also be separated into~     pain groups based on their response to injections. A correlation between exam findings and~     procedure group will be measured.~   "
61499|NCT02761915|"~     The purpose of this first in human study is to determine the safety and feasibility of~     1RG-CART therapy in patients with relapsed or refractory neuroblastoma. 1RG-CART therapy is a~     novel immunotherapy under investigation in which patients have their T-cells (a type of white~     blood cell) collected and modified in the laboratory, before they are given back to the~     patient. The T-cells are modified to express a chimeric antigen receptor (CAR) which targets~     disialoganglioside (GD2), a marker expressed on the surface of neuroblastoma cells.~   "
61500|NCT02761902|"~     The study is designed to investigate normal polysomnographic respiratory values of Chinese~     healthy children and adolescents. By collecting the polysomnography (PSG) data and parameters~     of respiratory and sleep architecture，we hope to characterize normal polysomnography values~     in Chinese children and adolescents and to establish respiratory reference values for~     pediatric polysomnography which based on Chinese children's data.~   "
61501|NCT02761889|"~     The present study evaluates the clinical outcomes following definitive ultra-high dose per~     fraction external beam radiation therapy delivered in patients with organ-confined~     adenocarcinoma of the prostate.~      Patients enrolled in the study will undergo image-guided, volumetric intensity-modulated arc~     radiotherapy (IGRT-VMAT) with state-of-the-art treatment-planning and quality assurance~     procedures with emphasis on normal tissue sparing and delivery accuracy via the use of~     devices that ensure stability and beam location reproducibility. A rectal balloon with air~     filling will be used for prostate target immobilization and anatomical reproducibility, while~     a urethral catheter loaded with beacon transponders will be used to ensure set-up~     reproducibility and online target tracking. Previously untreated patients with prostate~     cancer will be treated with 45 Gy in five fractions of 9 Gy over 5 consecutive days.~      Patients will be followed at one month post-treatment and every 3 months for up to 12 months~     (+/- 4 weeks) and every 6 months (+/- 6 weeks) thereafter. Acute and late toxicity~     evaluations will focus, though not exclusively, on urinary, rectal and sexual functions and~     will be assessed through validated Expanded Prostate Cancer Index Composite (EPIC),~     International prostate symptom score (IPSS) and International index of erectile function~     (IIEF) questionnaires. Serum Prostate Specific Antigen (PSA) values will be drawn on the same~     schedule as clinical follow-up. Patients will be continuously monitored for a minimum of 5~     years.~   "
61502|NCT02761876|"~     The purpose of this study is to test if a participatory, agroecological peer farmer-led~     education intervention can be effective at improving legume production, food security, and~     infant and young child feeding practices in Singida District, Tanzania.~   "
61509|NCT02761785|"~     The research aims to investigate the effects of gluten-free oats to the gastrointestinal~     health in celiac disease patients and healthy subjects. The effects of gluten-free oats on~     the several intestinal parameters, on the composition of the gut microbiota as well as on the~     metabolic profile of celiac patients and healthy controls will be studied. The study is~     divided into two parts.~      Part 1 will be conducted as a double-blind, randomized and placebo-controlled cross-over~     study. Healthy subjects will be recruited to the study. The aim is to recruit 15 participants~     for the part 1. The study will be conducted with a cross-over setting, where the subjects~     will go through exposure meals and SmartPill ingestion three times (two different oat~     products and placebo) in a randomized order. The study meals are identical in appearance and~     fiber content. After consuming the meal subjects will ingest the SmartPill capsule, which~     will send data on intestinal pH, pressure and temperature to the external portable device.~     Before and during the passage of capsule the subjects will fill a symptom and food diary. The~     capsule will exit the body in 1 to 3 days and the data collected by the external device will~     be collected and analyzed. Before the oat/placebo exposure the subjects will give a fecal and~     a blood sample. In addition, 36 hours urine samples will be collected.~      In part 2 celiac disease patients, non-celiac gluten sensitive subjects and healthy controls~     will be recruited and they will be divided into four groups: oat-avoiding celiacs (1),~     oat-consuming celiacs (2), non-celiac gluten sensitive subjects (3) and healthy controls (4).~     Recruiting aim for each group is 15 subjects. In addition to dietary data, a blood, and a~     fecal sample will be collected from the subjects. The gut microbiota will be analyzed from~     the fecal samples. The metabolic products will be analyzed from the fecal, urine and blood~     samples. The gut microbiota composition will be analyzed with next-generation DNA sequencing~     techniques.~   "
61510|NCT02761772|"~     Miscarriage is a common event associated with severe psychological and social morbidity,~     further tormenting in women suffering recurrent pregnancy loss (RPL) by at least three~     consecutive losses.~      Ultrasonography and biomarkers have yet to precisely predict viability in pregnancies with~     symptoms of threatening miscarriage.~      A novel biomarker Preimplantation Factor (PIF) derived by the developing embryo might be the~     key factor for this prediction ameliorating the implantation process by promoting a favorable~     local immune system in the uterus.~      The investigators aim to establish a prospective early pregnancy cohort (PEP-cohort) that~     includes women throughout the first trimester by both assisted reproductive technology (ART)~     and spontaneous conceptions. By a combination of consecutive ultrasonographys and blood~     samples of known predictors of implantation PIF as a predictor of viability will be~     evaluated.~      These data are finally compared to the same data in a retrospective cohort of RPL patients~     emphasizing the role of PIF.~      All collected data will be stored in a Research Biobank for the current studies outlined as~     well as potential future studies of reproductive medicine in the first trimester.~   "
61511|NCT02761746|"~     This study is a multi-site (Detroit, MI; Los Angeles, CA; Philadelphia, PA, and Washington,~     DC), two-group randomized controlled trial testing a two-session intervention designed to~     increase motivation for adherence to antiretroviral treatment (ART) among youth living with~     HIV (YLH) newly recommended to begin medications. Participants are randomized to receive the~     intervention, Motivational Enhancement System for Adherence (MESA), or the control condition,~     System for Health (SH: healthy eating and physical activity information). Both groups receive~     the standard of care regarding the initiation of ART. ART adherence (visual analog scale and~     hair sample assay) and health outcomes (viral load results, and CD4 counts) are assessed.~     Additionally, potential mediators (HIV knowledge, motivation for adherence, and self-efficacy~     for adherence) and predictors of intervention response (substance abuse, mental health~     symptoms, executive functioning, and stressful life events) are assessed.~   "
61512|NCT02761733|"~     The primary goal of the proposed study is to investigate the implementation and effectiveness~     of the mPOWR (Moving Patient-centered Outcomes through Wellness and Recovery) in diverse~     urban and rural community mental health settings. The study compares patient participation~     and outcomes using the mPOWR system to a usual care control condition. Four community mental~     health agencies participate in the research: two in San Francisco (urban) and two in N.M.~     (rural). One site in each setting serves as the mPOWR implementation site and the other~     serves as the control site. Service sites were randomly assigned to intervention or usual~     care conditions. A quasi experimental design was used; only eligible participants were~     enrolled in the study (e.g., exclusion criteria of moderate to severe cognitive impairment,~     patient services structured for provision of mPOWR implementation, etc.). The study design~     will employ repeated quantitative measures to assess change in outcomes within and across~     conditions over time. Qualitative methods in the form of focus group interviews will also be~     used to round out the information obtained about patient and provider expectations and~     experiences. Primary outcomes of interest include: Short Form Health Survey-12 (SF-12;~     physical and mental health aspects of health and well-being); Outcome Rating Scale (ORS;~     general well-being, personal well-being, close relationships, and work/school/friend~     relationships); Shared Decision Making Questionnaire (congruence of patient's and provider's~     participation in therapeutic decision making and patient's understanding of treatment and~     treatment options); Working Alliance Inventory (perception of therapeutic alliance); and~     Satisfaction Questionnaire (communication patterns between physicians and their patients).~   "
61513|NCT02761720|"~     The Mobile Mood Tracking App study is a small randomized trial of acceptability and usability~     of a mobile phone mood tracking application (mobile app) among women with depressed mood in~     pregnancy. The study will be assessing the perceived value and usability of this tool in~     pregnancy over eight weeks to test whether women using this app are more likely to receive~     assessments and treatments of depressed mood than women not using it.~   "
61514|NCT02761707|"~     This study seeks to establish the sensitivity and specificity of what appears to be a unique~     brainstem biomarker of Parkinson's Disease (PD) - an electrically induced olygosynaptic~     nasotrigeminal reflex response - in differentiating early stage PD from normal controls and~     from patients with various other neurodegenerative diseases. This study will additionally~     compare the biomarker to olfactory testing.~   "
61515|NCT02761694|"~     An open-label, Phase 1, dose escalation study of ARQ 751 in subjects with advanced solid~     tumors with AKT1, 2, 3 genetic alterations, activating PI3K mutations, PTEN-null, or other~     known actionable PTEN mutations~   "
61516|NCT02761681|"~     This study will develop and then test a web-based guided self-help version of Acceptance and~     Commitment Therapy (ACT) to be utilized at college counseling centers (CCCs). ACT is an~     evidence-based transdiagnostic therapy found to effectively treat a range of psychological~     problems. An ACT program would provide a means of implementing effective treatment for the~     range of problems in the CCC setting, while the guided self-help format would reduce~     counselors' workload, improving cost-effectiveness and reducing waiting lists. This would~     both treat students and train counselors in how to implement the ACT intervention.~   "
61537|NCT02761408|"~     The purpose of this study is to evaluate the effect of ALDH2 mutation in radiation~     associating dermatitis or mucositis in head and neck cancer patients who accept~     chemoradiation therapy~   "
61517|NCT02761668|"~     Pathologic tooth migration (PTM) is a common complication of advanced periodontitis and often~     motivation for patients to seek orthodontic therapy. An interdisciplinary approach is~     required to control the periodontal infection, reconstruct the defects and realign the~     migrated teeth. The optimal timing of active orthodontics after regenerative therapy is a~     topic of ongoing debate.~      There are no data available from RCTs that have compared the effect of the timing of~     orthodontic tooth movement (early vs. late) on the outcomes of regenerative periodontal~     surgery in these patients.~      It is the aim of the present randomized clinical multicenter trial to compare 2 different~     treatment protocols of a combined perio-regenerative and orthodontic therapy in advanced~     periodontitis patients with intrabony defects and pathologic tooth migration in order to~     establish whether one treatment modality is superior to the other with regard to clinical~     outcomes. A total of 46 patients will be enrolled and randomized into 2 treatment groups that~     differ by the time point of initiation of orthodontic therapy (early: 4 weeks vs. late: 6~     months following regenerative periodontal surgery).~      Primary outcome measure will be the change in clinical attachment level (CAL gain) at 12~     months after regenerative therapy. Secondary outcomes will include changes in probing depth~     BOP, gingival recession, radiographic bone height and patient-centered outcomes.~   "
61518|NCT02761655|"~     Background and Purpose: Previous studies indicate that baseline cognitive abilities,~     especially prospective memory (PM) significantly influence medication adherence. However,~     there are only three qualified intervention studies on adherences in persons with cognitive~     impairment (PWCIs). In addition, family caregivers (FCGs) are often asked to assist PWCIs in~     managing their medication but FCGs' medication administration hassles are not intensively~     investigated. Therefore, the purpose of this project is to test the effectiveness and~     efficacy of a theoretical-based multifaceted memory intervention on medication administration~     and quality of life in PWCIs living at home and medication administration hassle of their~     FCGs.~      Study Design: This is a three-year project (2015, 8, 1-2018, 7, 31). The aims of the~     first-year study are: 1.to develop a multifaceted memory intervention based on the paradigm~     of prospective memory (PM); 2. to pilot test the feasibility of the multifaceted memory~     intervention through a small randomized control trial. The aims of the second- to third year~     study are: 3. to examine the effectiveness and efficacy of the intervention (a randomized~     control trial). The intervention group will receive a cognitive impairment education,~     medication adherence and memory strategies training, while the control group will receive~     only the cognitive impairment education program. The duration of the intervention is one~     month. There will be 4 data collections (baseline, post-intervention 2 4, 6 months). Sample~     size estimation for the pilot study is 5 dyads for each group. Sample size for the randomized~     clinical trial is 84 dyads (42 dyads per group). After the attrition rate (10%) is counted,~     in total, there will be 200 cases (100 dyads). Implications of this project: This three-year~     program can help to identify those who may benefit from memory training and assist those who~     may be incompetent living in community. Also this program will extend the current knowledge~     of the role of PM playing in medication adherence behavior and its relationships with self~     awareness as well as everyday decision making among PWCIs. In addition, health related~     professionals can improve PWCI's quality of care and reduce FCG hassle by applying a~     theoretical guided practice for memory training.~   "
61519|NCT02761642|"~     This study will evaluate the efficacy and safety of subcutaneous (SC) r-HuEPO in anemic~     participants with breast cancer undergoing chemotherapy.~   "
61520|NCT02761629|"~     This randomized, multi-center, Phase IV, comparative study will assess the efficacy and~     safety of combined peg-interferon alpha-2a (Peg-IFN-Alpha-2A) and ribavirin therapy for 48 or~     72 weeks of treatment and 24 weeks of follow-up in participants with Genotype 1 chronic~     hepatitis C (CHC), co-infected with human immunodeficiency virus type 1 (HIV-1).~   "
61521|NCT02761616|"~     This is a retrospective, and observational cohort study to determine the proportion of breast~     cancer first relapses, that are biopsied. The duration of the study will be approximately 24~     months.~   "
61522|NCT02761603|"~     Over 30% of American adults have hypertension (HTN) (high blood pressure), and the rate~     increases considerably with age; 64% of men and 78% of women over 65 have HTN. High blood~     pressure associated with HTN can force of the blood against artery walls with enough pressure~     that it can eventually cause health problems, such as heart disease and stroke. HTN is one of~     the most significant causes of early death worldwide and one of the most preventable causes~     of death. Many studies reveal that lowering blood pressure (BP) reduces the incidence of~     diseases of the heart and blood vessels. Non-drug related treatments are known to reduce BP~     which can have a great effect on public health. Research suggests that Tai Chi (TC) is~     effective in lowering BP in patients with HTN, but because of the low quality of existing~     studies there is no definite proof. Also, it is not known how TC reduces BP. One possibility~     is that TC practice, which is shown to reduce psychological distress such as anxiety and~     depression and reduce the body's responses to stress, can improve the balance of the~     autonomic nervous system (the part of your nervous system that controls beating of the heart~     and the widening or narrowing of blood vessels). This may lead to lower BP. The investigators~     plan to investigate the pathways among autonomic, blood vessel, immune and psychological~     factors in relation to BP changes in response to 12-weeks of TC compared with Healthy Aging~     Practice-centered Education (HAP-E). 250 older adults (60+ years old) with mild HTN will be~     enrolled, and the investigators will take several measurements of heart and nervous system~     functioning. The investigators hypothesize that performing TC for 12 weeks will result in~     autonomic re-regulation which will improve BP and blood vessel health (Aim 1) and~     sympathetic nervous system (part of the nervous system that serves to speed up heart rate,~     contract blood vessels, and raise blood pressure) regulation of the immune system (Aim 2).~     Lastly, the investigators hypothesize that psychological factors will be related to TC~     effects on autonomic regulation (Aim 3). Findings from the investigators study will hopefully~     shed light on the pathways by which TC reduces BP. Also, the particular effects of TC~     (meditative movement) in an older, hard-to-treat hypertensive population will be better~     understood.~   "
61523|NCT02761590|"~     Introduction: The increase in intermuscular adipose tissue (IMAT) can contribute to muscle~     weakness and consequently on progression of knee OA. The prescription of exercise protocols~     has been used as a treatment strategy to minimize some of the bouts. Circuit training (CT)~     involves the combination of strength training and aerobic in the same session and has shown~     benefits in body composition and physical function. But the literature is unclear with~     respect to the influences of CT in the concentration of IMAT in the population with knee OA.~     Objective: To investigate the influence of a 14-week CT protocol in body composition and~     thigh IMAT concentration as well as cartilage degradation indicators and systemic~     inflammation and its impact on quality of life in patients with knee OA.~   "
61524|NCT02761577|"~     The study is analysis of the incidence of contrast-induced nephropathy (CIN) in patients with~     previously normal renal function undergoing angiography and comparison between the three~     different treatment protocols on renal function.~      Patients are randomly assigned to the three groups: 1) peroral hydration, 2) Na bicarbonate~     (NaHCO3), and 3) NaHCO3 plus N-acetylcysteine (NAC) infusion.~      Serum creatinine (SCr), blood urea nitrogen (BUN), and neutrophil gelatinase-associated~     lipocalin (NGAL) are measured before and 48 hours after the angiography. CIN was defined as~     an absolute increase of 0.5 mg/dL or a relative increase of >25% in creatinine levels 48-72~     hours after the procedure~   "
61538|NCT02761395|"~     1. Evaluate the therapeutic effects, health benefits, and immunological effect of~          Al-hijamah in children with beta thalassemia major.~        2. Evaluate the extent of clinical improvement, reductions in serum iron and ferritin,~          antioxidant status, in those patients.~   "
61811|NCT02757833|"~     Female participants with an episode of late-life depression (LLD) and age-matched control~     participants with no history of mental disorder will attend a one hour Magnetic Resonance~     Imaging (MRI). A 3 Tesla MRI scanner will be used to measure levels of glutathione (GSH) in~     the brain via magnetic resonance spectroscopy (1H MRS).~   "
61525|NCT02761564|"~     Current international guidelines suggest a restrictive transfusion strategy, setting that Hb~     level at 7 g/dl is a reasonable threshold. However, the idea of having only one threshold for~     all the patients has been challenged by authors, suggesting a more liberal strategy for~     certain cases. At the moment, there is no other parameter considered accurate enough to be~     taken into consideration for transfusion strategy management.~      This study is to use ScVO2, a current, easily accessible parameter, before blood transfusion~     in order to stratify its indication after cardiac surgery.~      Monocentric, randomised, single blind study (patient not aware of the group assignments)~     Patient inclusion will be made in ICU if the physician decides to perform blood transfusion~     according to standard transfusion strategy to treat a postoperative anemia (Hb<9g/dL).~      Every patient will go through randomization to be placed in one of the two groups of the~     study: either the one whose transfusion strategy is adjusted by the pretransfusion ScvO2~     (group ScvO2), or the control group.~      Our main objective is to evaluate the impact of a new transfusion strategy founded on~     guidelines, but provided ScvO2 is less than 65%, on the incidence of red blood cells~     transfusion for anemia early after cardiac surgery.~   "
61526|NCT02761551|"~     Despite U.S. guidelines for influenza vaccination of all children starting at age 6 months,~     only about half of children are vaccinated annually leading to substantial influenza disease~     in children and spread of disease to adults. A major barrier is that families are not~     reminded about the need for their children to receive influenza vaccination. The~     investigators will evaluate the impact of patient reminder/recall (R/R) performed by state~     immunization information systems to improve influenza vaccination rates by using three~     clinical trials in two states. The investigators will assess effectiveness and~     cost-effectiveness of phone reminder/recall on improving influenza vaccination rates. The~     investigators will disseminate the state immunization information system based~     reminder/recall system to all states for use for both seasonal and pandemic influenza~     vaccinations with the goal of lowering influenza morbidity.~   "
61527|NCT02761538|"~     The investigators developed the Aviitam® online platform. The purpose of the project is to~     test the medico-economic impact related to the utilization of the Aviitam online platform in~     primary care.~      Primary objective: To assess the cost-effectiveness at 24 months follow-up of the utilization~     of the Aviitam® online software in primary care for people with obesity and at least one~     comorbidity compared to a usual follow-up in primary care.~      Secondary objectives: Weight loss; quality of life ; blood pressure change; changes in lipid~     profile, blood glucose and HbA1c; physician satisfaction; patients satisfaction, profiling of~     patients and data mining analysis on the collected data.~      Method : Overweight & obese patients with associated comorbidities will receive a 24 months~     follow-up to assess the impact of the use of the online platform Aviitam®.~      Practitioners will be randomized by lot between an Aviitam® group and a control group (usual~     care).~      A medico-economic analysis will be conducted with a cost-effectiveness analysis and a budget~     impact analysis.~      With no hypothesis on the primary endpoint, the calculation of the required number of~     subjects was based on the quality of life. 150 patients will be included per group Patients~     of the 2 groups will be assessed at baseline and after 24 months. The first day of each~     month, each patient included in the study will receive a questionnaire to fill online to~     evaluate their health care consumption in the previous month and the EQ5D questionnaire , a~     standardized questionnaire validated in French to assess the effects on health and to be used~     to calculate cost - utility.~      Expected results and perspectives Proving the effectiveness of the Aviitam® online program~     focused on non-drug therapies and therapeutic lifestyle changes for overweight and obesity~     management with reduced health costs, improvement in quality of life, reduction in weight and~     improvement of comorbidities.~      In terms of public health, the use of the platform Aviitam® can be expect to improve~     management of excess body weight and reduced health costs. Furthermore, Aviitam® could be a~     valuable tool to support healthcare professionals in outpatient therapeutic education~     approaches.~   "
61528|NCT02761525|"~     The purpose of this study is to determine whether oral topic silver nanoparticles are~     effective to reduce potential pathogen microbial loads in mechanical ventilation patients.~   "
61529|NCT02761512|"~     To demonstrate non-inferiority of CJ-12420 to lansoprazole 30 mg capsule in terms of~     therapeutic efficacy, and to confirm safety of CJ-12420, after once daily oral administration~     of CJ-12420 50 mg, 100 mg or Lansoprazole 30 mg capsule in gastric ulcer patients.~   "
61530|NCT02761499|"~     This is a prospective, single arm, multi-center, post-approval study designed to evaluate the~     short and long term clinical performance and safety in subjects receiving primary total hip~     arthroplasty (THA) with the U-Motion II+ Acetabular System and UTF Reduced Stem.~   "
61531|NCT02761486|"~     Regular use of aspirin may reduce the incidence of colorectal cancer (CRC). However, it is~     unclear through which mechanism aspirin exerts its effect, in whom it decreases CRC risk and~     in whom it causes side effects. Recently, the imbalanced gut microbiome was linked to~     inflammation and CRC risk. The main hypothesis for this study is that aspirin may decrease~     CRC risk via targeting the gut microbiome. The study will be a randomized placebo-controlled~     double-blinded design, recruiting 50 healthy subjects, 50-75 years old, from the PRospective~     Evaluation of SEPTin 9 (PRESEPT) cohort living in the greater Twin Cities area, who will~     receive either aspirin or placebo for 6 weeks.~   "
61532|NCT02761473|"~     Pediatric mastocytosis is an orphan disease, which encompasses several clinically distinct~     entities including solitary mastocytoma, urticaria pigmentosa, diffuse cutaneous mastocytosis~     and the newly recognized mast cell activation syndrome. The most common form of pediatric~     mastocytosis is cutaneous maculopapular mastocytosis (CMPM), also known as urticaria~     pigmentosa (UP). There are significant knowledge gaps regarding the genetic basis of~     pediatric mastocytosis and the functional activity of mast cells in this condition. The~     Pediatric Dermatology and Pediatric Oncology services at the University of Minnesota Masonic~     Children's Hospital are seeing significant growth in clinical volumes of pediatric~     mastocytosis, including rare, familial cases. The aims of this study are to prospectively~     explore germline risk for UP and to perform a mutational analysis to identify somatic~     mutations, beyond those currently identified, in pediatric patients with UP.~   "
61533|NCT02761460|"~     The purpose of this study is to evaluate the safety and efficacy of PEG-rhG-CSF in preventing~     chemotherapy-induced neutropenia~   "
61534|NCT02761447|"~     This study evaluates the effectiveness of imagery motor on phantom pain and amputation~     process~   "
61535|NCT02761434|"~     Data from experimental animals and human epidemiological studies have suggested that~     hypohydration and/or low water intake is linked to poor glucose regulation and diabetes. The~     aim of this study is to investigate the effects of cellular dehydration on glucose in healthy~     non-diabetic individuals. METHODS: 60 males and females (30-55 y) will will undergo two~     experimental trials (ISO and HYP), consisting of a 2-h intravenous infusion of isotonic or~     hypertonic saline on two separate occasions, followed by a 4-h oral glucose tolerance test.~     Blood samples were taken from an antecubital vein in 30-min intervals starting at baseline~     for assessment of fluid and glucose regulating factors. Thirst will be assessed via visual~     analog following each blood sample. Energy substrate oxidation will be calculated via~     indirect calorimetry every 60 min.~   "
61539|NCT02761382|"~     This study evaluates the effects of psychological treatment on pain, quality of life and work~     ability among women with endometriosis related chronic pelvic pain in a three-armed,~     randomised study. One group will receive mindfulness-based psychological treatment, the~     second group will receive a non-specific general psychological treatment (a psychological~     placebo) and the third group will be a waiting list control (treatment as usual).~   "
61540|NCT02761369|"~     The neurobiological underpinnings of obesity point to brain asymmetry in cortical and deeper~     brain regions. Furthermore, chemical, structural and functional imbalance in cortical and~     sub-cortical brain regions alters reward processing, attentional control and self-regulation~     in food-addicted obese individuals. In this study the investigators use TMS with a special~     multichannel H-coil developed by their lab to safely stimulate cortical and deeper brain~     regions in obese humans. The investigators aim to produce interhemispheric neuroplasticity~     (INP) using a paired associative stimulation (PAS) protocol over the DLPFC, to restore~     neurobiological functioning, alleviate food addiction symptoms, and promote weight loss.~   "
61541|NCT02761356|"~     Patients cohort is composed of 50 consecutive patients both male and female with hepatic~     malignancies, refered to our nuclear medicine department in the process of radioembolization~     between January 2010- August 2015. 26 of the patients were examined with Tc99-MAA and~     SPECT-CT and 24 patients were examined with Tc99-MAA , SPECT-CT and PET-CT. Our study~     protocol was as follows:~        1. Collection of anamnestic data~        2. Calculation of liver tumor volume with quantification software~        3. Evaluation of the liver tumor involvement~        4. Evaluation of liver to lung shunt~        5. Calculation dose of SIRTEX~        6. Y90 imaging~        7. Follow Up~   "
61542|NCT02761343|"~     This study will evaluate the feasibility of visualization and characterization of arrhythmia~     ablation lesions by MRI immediately following standard ablation techniques. The appearance of~     the ablation lesion will be correlated with clinical outcomes and risk of arrhythmia~     recurrence.~   "
61543|NCT02761330|"~     This study is geared toward characterizing the recovery of brain activity and cognitive~     function following treatments of electroconvulsive therapy and ketamine general anesthesia.~   "
61544|NCT02761317|"~     The study compares the efficacy of bowel cleansing between the standard preparation (2 L~     polyethylene glycol electrolyte solution, 2 L PEG-ELS), low-volume preparation (10 mg~     bisacodyl plus 2 L PEG-ELS) and high-volume preparation (4 L PEG-ELS) in patients with~     previous colorectal resection.~   "
61545|NCT02761304|"~     The reduction in the rate of caesarean section is a major public health issue, it has reached~     21% in 2010 Fance. Indeed complications to expect during pregnancy and childbirth increase~     doubles the risk of fetal morbidity, néonatal and maternal history of when césareinne.~     recommendations for clinical practice (RPC) to scarred uterus are being drafted under the~     auspices of the National College of obstetrics and gynecology (CNGOF) well highlighting the~     health problem public this represents. During 2011, 15% of the 2,700 patients who have~     recently given birth to the north of Marseille Hospital were carriers of a scarred uterus~     (internal data).The objective of the obstetrician is to ensure the welfare mother and fetus~     at the end of pregnancy and childbirth. To do this, the realization of a work being cesarean~     allows in some cases to reduce neonatal morbidity related to workflow especially in case of~     abnormal fetal pericardial pace that suggest fetal hypoxia. However, a significant number of~     caesarean section is performed by the side of caution during the second part of the work to a~     suspicion of non-engagement of the fetal presentation. These caesareans are indicated,~     rightly, before a clinical doubt about the height of the engagement of the fetal presentation~     in order to avoid making a difficult instrumental delivery, potentially harmful to the mother~     (perineal tear 3rd and 4th degree) and fetus (head injury, intracranial hemorrhage,~     cephalohematoma). A prospective study published in the Lancet estimated 37% error percentage~     attributable to the clinical examination in case of doubt on the commitment of presenatation~     fœtale. The CNGOF held through PRC publication what to do in case of obstetric clinical doubt~     about the commitment of the fetal presentation and not recommended no show against an~     instrumental extraction in this situation (RPC 2008).~      Ultrasound has revolutionized pregnancy monitoring. Its routine use has in other prenatal~     diagnosis of fetal pathologies, it is the other reference screening tool of the most common~     obstetric pathology, preterm labor. Its use became widespread in the delivery room, the~     presence of an ultrasound machine is recommended by the decrees of perinatal care in~     maternity hospitals performing more than 1,500 deliveries per year. It is natural for~     conducting ultrasound during labor has emerged, first to help identify the variety of the~     presentation of the fetal head and then more recently in aid to instrumental delivery.~     Several studies have shown that ultrasound had a sensitivity of commitment over 90% for~     predicting the success of instrumental extraction and a vaginal delivery.~      To our knowledge, to date, there is no study that investigated the benefit of ultrasound~     commitment to reduce the rate of cesarean section during labor. To answer this question, we~     want to show that making a commitment in case of diagnostic ultrasound of doubt about the~     level of engagement of the fetal head (4% of births) reduces by 30% the rate of caesarean~     section fully dilated.~   "
61546|NCT02761291|"~     Nasopharyngeal carcinoma (NPC) is an Epstein-Barr virus(EBV) related malignancy and is an~     endemic disease in Southeast Asian countries. EBV had been identified as a therapeutic target~     in some EBV related cancer such as lymphoma and NPC. In cancer cell, EBV was in latent phase~     and expressed 8-11 genes for maintaining EBV proliferation. After switching to lytic phase,~     almost all the EBV encoding genes were expressed including thymidine kinase (TK) and some~     highly immunogenetic genes. These latent-lytic phase swifter included DNA methyltransferase~     inhibitors, various histone deacetylase (HDAC) inhibitors, radiotherapy and chemotherapy.~     Recently, combined chemotherapy and viral lytic therapy, cytolytic viral activation therapy~     (CVAT) had been shown some promising result in pilot study of NPC. In our patient derived~     xenograft (PDX) animal model drug sensitivity screening, gemcitabine (GEM) was shown to be~     the most effective drug. Furthermore, CVAT with GEM + Valproic acid (VPA) + ganciclovir (GCV)~     maintaining chemotherapy may benefit but reduce chemotherapy related side effect and~     prolonging treatment response duration. The following phase I clinical trial will be proposed~     to test the optimal combination of these drugs.~        1. Number of patients: total 18 patients are needed~        2. Inclusion criteria:(1) used as 2nd line regimen in recurrence/metastasis NPC patients~          with tissue proved of World Health Organization (WHO) type II or type III.(2)~          Performance status: eastern cooperative oncology group performance status (ECOG PS) ≤2.~        3. Chemotherapy regimen: Gemcitabine (GEM, TTY) + Valproic acid (VPA, generic medicine) for~          viral activation + Valganciclovir (VGC, Roche) for antiviral medication~        4. This treatment cycle of 28 days was repeated maximum 6 times. (Q4wks/cycle, max: 6~          cycles)~        5. Dosage:~      (1) GEM: 600, 800, 1000, 1250 mg/m^2, D1 & D8, intravenously. (2) VPA 12.5 mg/kg/day D1~14,~     per os. (3) VGC (2-3) x 450 mg/day D9~15, per os. 6. Objectives:~        1. primary: to find the best combination of these 3 drugs in recurrent/metastatic NPC~          patients.~        2. second: to evaluate the response and disease control rate in this pilot study.~      Key words: NPC, cytolytic viral activation therapy, gemcitabine, valproic acid, ganciclovir.~   "
61547|NCT02761278|"~     The aim of this study is to measure the expression of HOXA10 and HOXA11 in the endometrium of~     infertility patients with an endometrial polyp before and after polypectomy. HOXA10 and~     HOXA11 are well-established markers of implantation. It is uncertain as to whether an~     endometrial polyp interferes with embryo implantation. A higher expression of HOXA10 and~     HOXA11 after polypectomy can indicate that endometrial polyp does interfere with embryo~     implantation.~   "
61548|NCT02761265|"~     Surgical intervention may provide pain relief and improvement in function but one area of~     significant clinical interest is the restoration/improvement in gait and functional balance.~     Based on the investigators knowledge, there is limited literature on biomechanics and~     neuromuscular control of the lower extremities and spine as assessed by objective gait~     analysis and balance strategies in adult degenerative scoliosis patients, pre and post~     surgical intervention. The purpose of this study is to determine the impact of spinal~     deformity on the biomechanics and neuromuscular control of the lower and upper extremities,~     and also investigate the impact of surgery on these functions as evaluated by gait and~     balance analyses using dynamic EMG, video motion capture and force plate analysis and also to~     compare these patients with healthy controls to better evaluate the extent of limitations~     before and after surgery.~   "
61549|NCT02761252|"~     The purpose of this study is to compare concomitant administration of Montelukast and~     Bilastine to Montelukast and Bilastine monotherapies in patients with SARC and asthma~   "
61550|NCT02761239|"~     The investigators hypothesized that, external branch of the superior laryngeal nerve (EBSLN)~     and/or recurrent laryngeal nerve (RLN) contribute to the motor function of the human~     cricopharyngeal muscle (CP). The investigators aimed to assess the contribution of the~     laryngeal nerves (EBSLN and RLN) to the motor activity of the cricopharyngeal muscle, during~     thyroidectomy with intraoperative neuromonitoring (IONM).~   "
61551|NCT02761226|"~     Implants have become the preferred method of single tooth replacement these days, patients~     receiving implant treatments not only expect restoration of masticatory function, they also~     expect that the prostheses will be esthetically pleasing, easy to clean, and permanent. To~     maintain long-term implant stability, it is important to minimize bone loss around the~     implant, as well as the soft tissue atrophy that accompanies it.~   "
61552|NCT02761213|"~     The aims of the present study is to compare oral sulfate solution (OSS) with low-dose~     polyethylene glycol plus ascorbic acid (2-L PEG/Asc) for bowel cleansing efficacy.~   "
61553|NCT02761200|"~     This exploratory study is designed to ensure the safety of HIV-infected volunteers who~     complete research protocols that include an analytic treatment interruption (ATI). This is a~     prospective cohort study of volunteers who were diagnosed with HIV during early acute HIV~     infection, treated with antiretroviral therapy (ART) and subsequently enrolled in a clinical~     study that included ATI. After completion of study participation that involves ATI,~     participants will be recruited into this study for continued clinical and laboratory~     monitoring.~   "
61554|NCT02761187|"~     The purpose of this study is to describe contemporary, real-world patterns of patient~     characteristics, clinical disease presentation, therapeutic regimen chosen, and clinical~     outcomes in participants with newly diagnosed [ND] multiple myeloma (MM) and participants~     with relapsed/refractory [R/R] MM.~   "
61555|NCT02761174|"~     The aim of the study is to investigate whether brimonidine cream can reduce IPL-induced~     inflammation in terms of redness, swelling and pain in patients with facial vascular lesions~     (telangiectasias). Furthermore, the effect of brimonidine cream on IPL-efficacy is evaluated~     one month after final IPL-treatment.~      The hypothesis is that brimonidine, which has been proved effective in reduction of~     symptomatic erythema in patients with rosacea, also may have the ability to reduce~     IPL-induced erythema. Since the potential reduction in erythema is caused by~     vasoconstriction, brimonidine may further reduce IPL-induced oedema and pain.~   "
61556|NCT02761161|"~     The overall aim of this study is to examine the effects of sleep enhancing treatment in~     refugees with PTSD.~   "
61557|NCT02761148|"~     White matter hyperintensity (WMH) has been found to be related with cognitive and emotional~     dysfunction. A presumed mechanism is that WMH disrupts the structural connectivity within a~     large-scale brain network, thereby impairing the brain's ability to integrate the neural~     processes efficiently. It is not yet clear, what the pattern of brain network disruption~     relates to WMH and how the brain network disruption induced by WMH has an effect on cognition~     and emotion performance. Using multi-model magnetic resonance imaging (MRI) techniques, we~     aimed to explore the mechanisms of cognitive decline and depression related with brain~     network dysfunction in patients with WMH, and to provide objective imaging marker for early~     diagnosis and prevention of WMH associated cognitive decline and depression.~   "
61558|NCT02761135|"~     Prostate cancer is the most common cancer among men in Sweden. During investigation of~     suspected cancer transrectal ultrasound with needle biopsies from prostate leeds to~     diagnosis.~      The most common technique today is side-fire where the needle enter the prostate in angle~     from the probe. In end-fire technique the needle enters the prostate at tip of probe without~     angle. The difference in techniques side-fire vs. end-fire affects the possibility to reach~     the ventral and apical aspects of prostate.~      Today´s standard is at least five cores from each side of the prostate at first biopsy. If~     first sample is negative there will usually be another urological exam and a first re-biopsy.~      The study aim to compare these two methods in cancer detection. The investigators' hypothesis~     is that when using end-fire technique at first re-biopsy, investigators find more cancers~     compared to side-fire.~      Patients are prospectively randomized into two groups, both assessing 12 core biopsies~     according to study protocol.~      Primary endpoint is cancer detection. Data will be collected about patient age, PSA-level,~     prostate size, digital rectal exam, hypoechogenic zones and length of cancers.~   "
61559|NCT02761122|"~     Lichen planus is a chronic cutaneous and mucosal disease characterized by the infiltration of~     cluster of differentiation (CD) CD8 T lymphocytes, localized under the basal membrane and~     associated with apoptosis of basal keratinocytes, suggesting a reactivity of T lymphocytes~     toward keratinocyte antigen(s), so far unidentified. In a recent study, the research team at~     Institut Pasteur has demonstrated in a peculiar clinical form of lichen planus (erosive~     lichen planus), that the immunogenic target of CD8 T lymphocytes could be the immunodominant~     peptide of Human Papilloma Virus (HPV) 16.~      In line with this recent work which shows for the first time a link between HPV-16 and an~     autoimmune disease, erosive lichen planus, the aim of te study is to test the hypothesis that~     HPV could be also involved in the pathogenesis of other clinical forms of lichen, such as non~     erosive lichen planus or lichen sclerosus.~   "
61560|NCT02761109|"~     Incidence and risk factors for renal, cardiovascular and pulmonary complications after liver~     transplantation are not well defined. Blood products requirement is an important aspect of~     orthotropic liver transplantation (OLTx) management and has a great impact on patient's~     outcome. Transfusions of blood products increase perioperative complications and reduce graft~     and patients survival.~      The primary endpoint of the study is to evaluate the incidence of renal complication during~     ICU stay after liver transplantation using RIFLE criteria; secondary endpoint is to evaluate~     the incidence of cardiovascular and pulmonary complications. In addition patients' survival~     and the relationship between blood components use with the development of post-operative~     complications are evaluated.~   "
61561|NCT02761096|"~     The aim of this study is to evaluate the effect of acupuncture on inflammation and immune~     function after craniotomy. This study will be a single-center, parallel group clinical trial~     that will be conducted at Kyung Hee University Hospital at Gangdong, Seoul, Korea.~   "
61562|NCT02761083|"~     The aim of this study is to show that the performance of Novosyn® Quick suture material is~     comparable with standard suture material used in Ophthalmic surgery. In order to show that,~     various safety and efficacy parameters have been selected. The outcome regarding these~     parameters will be compared in 2 treatment groups. Active control group will receive Vicryl®~     Rapide and the treatment group Novosyn® Quick for ophthalmic surgery. It was decided to~     design this study as a randomized trial, because limited clinical evidence is available in~     the literature for the active control group (Vicryl® Rapide) which can be used for~     comparison. Eye operation will be randomly allocated on the left and right side (1:1) to both~     treatment groups.~      Patients undergoing elective, primary ophthalmic surgery (dacryocystorhinostomy, ectropion,~     entropion, ptosis, eyelid tumor resection, blepharoplasty)~   "
61563|NCT02761070|"~     The aim of this Phase III study is to evaluate the superiority of dose-dense temozolomide~     (ddTMZ) followed by bevacizumab at ddTMZ failure for glioblastoma at first recurrence or~     progression, comparing to bevacizumab alone.~   "
61622|NCT02760290|"~     Cesarean section will performed via intraperitoneally and extraperitoneally. During~     postoperative period pain, need for analgesia, respiratory function tests, ileus, bowel~     movement, discharged time will be compared.~   "
61564|NCT02761057|"~     This randomized phase II trial studies how well cabozantinib s-malate, crizotinib, volitinib,~     or sunitinib malate work in treating patients with kidney cancer that has spread from where~     it started to nearby tissue or lymph nodes or to other places in the body. Cabozantinib~     s-malate, crizotinib, volitinib, and sunitinib malate may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth.~   "
61565|NCT02761031|"~     This study will record patient electrocardiograms - as well as various other body signals~     (e.g., blood pressure, pulse wave, peripheral hemoglobin oxygen saturation) - as monitored~     routinely both during and immediately subsequent to surgical operations performed under~     general anesthesia. Through retrospective analysis of patients' heart rate variability (HRV),~     in concert with the other abovementioned parameters, the investigators seek to forward the~     development of novel mathematical models and tools for on-line detection of cardiovascular~     and autonomic dysfunction in the perioperative setting.~   "
61566|NCT02761018|"~     The investigators will recruit DoD beneficiaries, aged 18 years or older and diagnosed as~     being Type II diabetic. Patients will be randomized into one of two groups. Group 1 will use~     a fitness tracker but will not be able to see other participants data and group 2 will use a~     fitness tracker and will be able to see other members daily and weekly results. Outcome~     measures will be assessed at baseline, 3 months and 6 months to include hemoglobin A1c,~     weight, body mass index, blood pressure, and number of hours and days fitness tracker is~     used. The goal is to see if the group randomized into an online community will have improved~     activity and outcome measurements compared with those who use the pedometer alone.~   "
61567|NCT02761005|"~     Patients infected with H. pylori are treated with the individualized regimen which is based~     on the mutation of 23S rRNA of H. pylori.~   "
61568|NCT02760992|"~     The purpose of this study is to identify a suitable dosing regimen of IV baclofen to serve as~     a temporary substitute for an oral regimen.~   "
61569|NCT02760979|"~     This study evaluates the effect of Denosumab in decreasing the periprosthetic bone resorption~     after Total Knee Arthroplasty compared to placebo in 60 patients (30 placebo and 30~     Denosumab) within a year after surgery.~   "
61570|NCT02760966|"~     Evaluate the effectiveness of alcohol 70º compared with soap on cord separation time and the~     complication rate in the newborn.~   "
61571|NCT02760953|"~     The purpose of this study is to evaluate the safety and efficacy of applying cryoablation as~     an adjuvant therapy with TUR to treat bladder tumor.~   "
61572|NCT02760940|"~     Anemia is a clinical manifestation, which is commonly observed in patients with inflammatory~     bowel disease, and it accounts for significant loss in the quality of life of these patients.~     The aim of the current study is to assess the effect of orally administered iron treatment,~     as well as its response predictors in patients with inflammatory bowel disease who are in~     remission and present anemia. The study will recruit 100 patients with Crohn's disease (CD)~     and 100 patients with ulcerative colitis (UC) diagnosed and regularly monitored in the~     Inflammatory Bowel Disease Center at the University Hospital of the Federal University of~     Juiz de Fora, for clinical, hematological, biochemical and immunological assessment. Blood~     samples will be collected (10 ml) and the following tests will be performed in all the anemia~     patients (in remission) at the beginning of the treatment and 8 weeks later: complete blood~     count, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular~     hemoglobin concentration (MCHC), erythrocyte sedimentation rate (ESR) , transferrin~     saturation index, ferritin, serum iron, hepcidin, quantitative C-reactive protein (CRP),~     interleukin-6 (IL-6)) and fecal calprotectin. In addition, quality of life, anxiety and~     depression and fatigue questionnaires will be applied to the patients (IBDQ, HAD and~     Chalder). The World Health Organization (WHO) criteria will be used to diagnose anemia,~     therefore, hemoglobin lower than 12 g/dl for women and 13g/dl for men will be considered~     anemia; hemoglobin lower than 10 g/dl will be considered severe anemia. Patients with mild~     and moderate anemia in remission will be initially treated with oral iron (oral liposomal~     iron) and the occurrence of possible symptoms related to oral iron intolerance will be~     assessed, as well as the patients' disease activity level and quality of life. The patients~     in follow-up will be subjected to new laboratory tests after the eighth oral iron treatment~     week. The results of the current study are expected to help assessing the oral iron efficacy~     and response predictors, as well as the side effects of the treatment and its impact on the~     quality of life of patients.~   "
61573|NCT02760927|"~     Assessment of AnchorFast Guard Oral Endotracheal Tube Fastener on Patients Intubated with~     Oral Endotracheal Tubes with Subglottic Suction~   "
61574|NCT02760914|"~     The aims of the present project are to study possible differences in inflammatory gene~     expression and protein secretion in various compartments of adipose tissue being exposed~     during open cardiac surgery in patients with coronary heart disease undergoing coronary~     artery bypass surgery.~   "
61575|NCT02760901|"~     Cisplatin is a major anti-neoplastic drug used for the treatment of solid tumors. Its chief~     dose limiting side effect is nephrotoxicity. Twenty percent of patients receiving high-dose~     cisplatin undergo severe renal dysfunction. Acetazolamide and N-acetylcysteine (NAC)~     ameliorated Cisplatin-induced nephrotoxicity in rats. No study to date evaluated the~     protective effect of acetazolamide or NAC against cisplatin nephrotoxicity in humans.~      Aim of the study was to evaluate the effect of acetazolamide or NAC against cisplatin~     nephrotoxicity in humans compared to mannitol and to each other.~      Patients and methods. A total 52 patients receiving standard hydration measures for cisplatin~     were randomized to three groups: 20 patients receiving mannitol, 15 patients receiving~     acetazolamide and 17 patients receiving NAC. Patients` kidney function was monitored using~     serum creatinine, creatinine clearance and blood urea nitrogen; kidney injury was assessed~     using RIFLE criteria. Patients` liver function tests and hematological parameters were also~     monitored.~   "
61576|NCT02760888|"~     The purpose of this study is there difference between the effect of Tramadol orally and~     Diclofenac orally with respect to : analgesic efficacy during diagnostic hysteroscopy in~     nulliparous women.~   "
61577|NCT02760875|"~     Using a population of patients from another study, who was originally randomized to 2~     different types of nonoperative treatment after an acute achilles tendon rupture, the length~     of the achilles tendon is examined using ultrasound, and foot pressure mapping is performed,~     4-5 years after the injury.~   "
61578|NCT02760862|"~     Fifty patients of both sex, aged 18-50 years and ASA I and II undergoing elective lower~     abdominal and pelvic surgery under spinal anesthesia were included in this randomized~     double-blind study. Patients were randomly divided into 2 groups 25 each; group (I) received~     intravenous hydrocortisone 100mg every 8 hours for 48 hours and group (II) received~     intravenous infusion of mannitol 20% 100ml over 30 minutes followed by 100ml every 12hours.~     Mean (+/- SD) of headache intensity at 0, 6, 12, 24 and 48 hours after beginning of treatment~     was assessed using visual analog scale.~   "
61623|NCT02760277|"~     The main purposes of this study are to see if it is safe to use a new medication called~     vamorolone for more than two weeks in children with Duchenne muscular dystrophy (DMD), to see~     if vamorolone works for the treatment for DMD, and to see how any potential side effects~     compare to those seen in boys using steroids.~   "
61579|NCT02760849|"~     The goal of this clinical research study is to compare the changes in female sexual function~     between patients having interval salpingectomy with delayed oophorectomy (ISDO) with those~     having risk-reducing salpingo-oophorectomy (RRSO) in women who carry genetic mutations.~     Researchers also want to learn how these surgeries affect your quality of life.~      RRSO is the standard surgery for patients with certain types of genetic mutations, where the~     fallopian tubes and ovaries are removed at the same time.~      ISDO is surgery to remove the fallopian tubes first, then the ovaries are removed during a~     second, later surgery. Most women with genetic mutations will be encouraged to remove the~     ovaries around the ages of 40 to 50. The decision in timing to remove your ovaries will be~     made with your doctor.~   "
61580|NCT02760836|"~     The purpose of this study is to develop and validate a predictive model of clinical outcomes~     based on the results of web-based self-reporting symptom diary for Crohn's disease.~   "
61581|NCT02760823|"~     The aim of this study is to evaluate efficacy and safety of Alpha Lipoic Acid(ALA) as an~     adjuvant in the management of patients with acute phosphide poisoning.~   "
61582|NCT02760810|"~     This is an 8-visit, bilateral, dispensing clinical study to evaluate the change in tear fluid~     pH and tear film osmolarity in an FDA-cleared contact lens in new contact lens users over a~     14-day period.~   "
61583|NCT02760797|"~     This is an open-label, multicenter study designed to assess the safety, pharmacokinetics,~     pharmacodynamics, and therapeutic activity of emactuzumab and RO7009789 administered in~     combination in participants with locally advanced or metastatic solid tumors that are not~     amenable to standard treatment. This study will be conducted in two parts: a dose-finding~     stage (Part I) and an expansion stage (Part II).~   "
61584|NCT02760784|"~     A total of 56 patients completed a previous study regarding non-operative treatment for acute~     achilles tendon rupture. This study consists of an additional follow up after 4-5 years~     depending on original date of injury.~   "
61585|NCT02760771|"~     Prior to the deployment of transcatheter heart valves (THV), balloon aortic valvuloplasty~     (BAV) is often performed under rapid right ventricular pacing (burst >180 bpm) with the~     induction of a functional cardiac arrest for up to 30 seconds. Aortic valve predilation aims~     at facilitating the crossing of the aortic annulus, accurate valve positioning and does also~     provide information on the anatomy of the valve complex. However, BAV has been shown to have~     a number of potentially detrimental effects.~      There is limited experience for the balloon expandable Edwards THV on the need for~     predilation (BAV). Experience so far has only been documented from smaller, uncontrolled case~     series.~      The investigators aim to document the incidence of several kinds of complications in a large,~     multicenter registry / prospective controlled cohort study to identify associations between~     patient related variables and outcomes.~   "
61586|NCT02760758|"~     This is a First in Human study of orally administered CDI-31244, a non-nucleoside inhibitor~     (NNI) in healthy volunteers and HCV infected individuals~   "
61587|NCT02760745|"~     Febrile shivering in the pediatric population is assumed to be related to a Severe Bacterial~     Infection (SBI). Research supporting this assumption is scant. The purpose of this study is~     to describe the frequency of febrile shivering in the pediatric population arriving at the~     emergency department and to define its role in predicting a SBI.~   "
61588|NCT02760732|"~     This study was to investigate the effect and safety of drug eluting balloon combined for~     treatment of unstable angina.~   "
61589|NCT02760719|"~     This study evaluates the effectiveness of nebulized 3% hypertonic saline solution with~     salbutamol in the treatment of children under 2 years, hospitalised for acute viral~     bronchiolitis. Half of the participants will receive nebulized 3% hypertonic saline solution~     with salbutamol three times daily, the other half will receive standard supportive care,~     which is the cornerstone of the bronchiolitis management.~   "
61590|NCT02760706|"~     Study hypothesis: Post-processed SDCT images provide additional diagnostic value over~     conventional CT datasets.~      The CT examination would be a clinically-necessary, standard-of-care CT performed as per the~     clinical indication. The protocol and scan parameters for the CT exam will be similar to that~     of an equivalent scan performed with any other CT scanner. There would be no additional~     scanner of injection of any drug specifically for the study. The conventional CT images~     generated by the scanner will be used for clinical purposes as routinely practiced.~   "
61591|NCT02760693|"~     monitoring system and data base for long term follow up of various treatment strategies in a~     naturalistic setting of recurrent affective disorders (unipolar, bipolar) open study design,~     prospective & retrospective~   "
61592|NCT02760680|"~     A prospective validation study: Level I-full night-polysomnography (PSG) versus a diagnostic~     device with measurement of the peripheral arterial tone (PAT) of patients with chronic heart~     failure (CHF) and sleep-disordered breathing (SDB).~   "
61593|NCT02760667|"~     The objective of this study is to assess the efficacy of induction chemotherapy followed by~     transoral surgical treatment and neck dissection, in definitive management of moderately~     advanced oropharyngeal squamous cell carcinoma. The surgical treatment will carry out~     Transoral Robotic Surgery (TORS) or Transoral Laser Microsurgery (TLM) for the primary tumor,~     and neck dissection for the management of cervical lymph nodes.~      The primary outcome measure will be disease specific survival (DSS). The secondary oncologic~     outcome measures will be locoregional control, relapse free survival, overall survival, and~     Quality of Life (QOL).~   "
61594|NCT02760654|"~     The purpose of this pilot randomized wait-list controlled trial is to test the efficacy of an~     online cognitive behavioral pain management website called Proactive Self-Management Program~     for Effects of Cancer Treatment (PROPSECT) to reduce worst pain intensity for individuals~     with chronic painful chemotherapy-induced peripheral neuropathy (CIPN) and to explore the~     mediating effect of PROSPECT-induced changes in anxiety, fatigue, depression, and sleep~     disturbance on worst pain intensity. Another aim of this study is to determine whether~     PROSPECT will decrease CIPN symptom severity (e.g. non-painful numbness and tingling),~     average pain severity, and physical impairment. Lastly, since this intervention has never~     been tested in individuals with painful CIPN, the investigators will assess patients'~     perceptions of acceptability and satisfaction with the intervention.~   "
61595|NCT02760641|"~     The purpose of this study is to determine the effects of change in diet quality (carbohydrate~     restriction versus fat restriction) on body composition, fat distribution, cardiometabolic~     risk factors, physical function, and quality of life in aging adults with obesity.~   "
61596|NCT02760628|"~     The First Twenty® (TF20) was recently developed as a not-for-profit, web-mobile program for~     firefighters (FFs) specifically focused on improving fitness and nutrition knowledge and~     practices. The program was designed by FFs with backgrounds in tactical fitness, marketing~     and program development professionals, and nutrition and exercise scientists. Preliminary~     data suggests the program is well-received by FFs and results in significant improvement in~     body composition and physical fitness. One innovative approach for the eventual dissemination~     of TF20 to VFFs is through their fitness-for duty medical exams. The synergy created by~     linking the TF20 intervention components, feedback to the VFFs from their medical exam, and~     health messages from their physician is predicted to maximize the impact of this much-needed~     intervention. The goal of the proposed project is to tailor TF20 for use in a clinic based~     setting (CB-TF20) for VFFs and to pilot test it in comparison to the American Heart~     Association's Life's Simple 7 (LS7), a web-based diet and physical activity~     knowledge/behavior and lifestyle program. The specific aims are to: 1) Conduct formative~     research with key stakeholders in the VFF community (e.g., physicians, department leadership,~     VFFs) to determine best practices for implementing a clinic-based, web-mobile health and~     wellness program with VFFs and medical providers; 2) Develop a clinic-based version of TF20~     (CB-TF20) and beta-test it with VFFs; and, 3) Conduct a 6 month, 2-arm, pilot cluster (i.e.,~     department) randomized clinical trial (PCRCT) to determine the comparative effectiveness of~     the revised CB-TF20 to LS7 on body composition, Framingham Risk Scores, and diet/physical~     activity knowledge and behaviors among VFF with BMI >25.0kg/m2; and conduct an evaluation of~     the CB-TF20 materials and technology. This innovative R34 study is a critical step in~     providing a much needed intervention for VFFs and those providing their annual examinations.~   "
61597|NCT02760615|"~     The purpose of this study is to evaluate in a step-wise approach the disease drug-drug~     interaction (DDI) potential for vedolizumab to indirectly affect the exposure of cytochrome~     P-450 (CYP) substrate drugs by modulating pro-inflammatory cytokines in participants with~     ulcerative colitis (UC) or Crohn's disease (CD) who are treated with vedolizumab.~   "
61598|NCT02760602|"~     The main purpose of this study is to investigate the safety and efficacy of the study drug~     solanezumab in participants with prodromal Alzheimer's disease (AD).~   "
61599|NCT02760589|"~     The purpose of the study is a clinical evaluation with special regard to magnetic resonance~     imaging and functional performance at least one year after injury / surgery in all three~     groups (subjects who underwent InternalBrace surgery, subjects who underwent surgery with a~     semitendinosus graft and subjects who were treated conservatively).~   "
61600|NCT02760576|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
61601|NCT02760563|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
61602|NCT02760550|"~     The objectives of this policy-related survey are as follows:~      i. to study updated trend and prevalence on secondhand smoke, smoking-attributed health~     effects, cessation services; ii. to investigate the level of public support on current and~     future tobacco control measures and taxation policies; iii. to address the timely impacts of~     smoke-free policies, substantiate public support on further tobacco control measures and~     assist Hong Kong Council On Smoking and Health (COSH) in shaping policy direction for~     government.~      Purpose of the study is to provide evidence and support for smoke-free policy development in~     Hong Kong.~   "
61603|NCT02760537|"~     The study was conducted between April 2013 and October 2014. In the parent study, 600~     foreign-born Asian American adults 18 years of age and older were drawn from the community in~     the Baltimore Washington Metropolitan Area. Using a non-probability sampling method,~     foreign-born Asian American adults, 18 years of age and older, were recruited from the~     community.~      After providing informed consent, all the participants were asked to complete a~     self-administered questionnaire in English, Chinese, Korean, or Vietnamese with the~     assistance of a bilingual interviewer when necessary. Then, all of the participants were~     instructed and given 5 to 10 to minutes to read culturally integrated and linguistically~     appropriate educational material (e.g., Photo novel) developed and validated for efficacy~     from a prior study.~      All participants received hepatitis B testing: HBsAg (hepatitis B surface antigen), HBsAb~     (hepatitis B surface antibody) and, HBcAb (hepatitis B core antibody). A total of 600~     completed the survey and screening. A week later, they received the results of the screening~     test. Based on the screening results, all participants were categorized into three groups:~     (1) infected (HbsAg+), (2) unprotected (HbsAg-/HbsAb-), or (3) protected (HbsAg-/HbsAb+). We~     sent the results by mail to participants who were unprotected and protected. Among those 600~     screened participants, 33(5.5%) had chronic hepatitis B virus (HBV) infection and 335 (55.8%)~     had evidence of resolved HBV infection (protected). A total of 232 (38.7%) were susceptible~     to HBV infection (unprotected).~      LHW (lay health worker) Intervention for those unprotected: Those unprotected (n=232) were~     randomly assigned to either the intervention (n=124) or the control (n=108) groups by~     computer-automated random assignment. Randomization was used to assure equivalence between~     groups on key factors that may potentially influence the outcome of HBV vaccinations: gender,~     age, education, length of stay in the U.S.~      LHWs conducted phone interventions by reminding participants of a series of vaccinations at~     months 1, 2, and 5 among those assigned to the intervention group. Those in the control group~     received a list of resources along with their results by mail that offered free vaccinations,~     such as local health departments. Seven months after mailing the results, those unprotected~     were followed up by phone to ask about their status of the series of vaccinations and about~     promoters or barriers to vaccinations.~   "
61604|NCT02760524|"~     The major goal of this study is to determine whether Neuro-Emotional Technique is a viable~     treatment option for decreasing distress in cancer patients. The potential advantages of NET~     are: 1) it is designed specifically to address distressing stimuli and unresolved emotional~     memories; 2) it is a brief, time-limited intervention; and 3) its multi-modal design may~     appeal to and benefit a broader range of patients than a single mode intervention~   "
61605|NCT02760511|"~     Anthocyanins are naturally existing, polyphenolic compounds found in the vacuolar sap of the~     epidermal tissues of flowers and fruits, with a pink, red, blue, or purple color. Recently,~     study of anthocyanin pigments has drawn more and more interest since several epidemiological~     studies have demonstrated their health-promoting properties, such as reducing lipid~     accumulation and decreasing oxidative stress and inflammation. Nevertheless, there is a clear~     need for advancing understanding with regard to effective amounts of intake for these~     phytochemicals. The aim of this study was to investigate the efficacy and pharmacokinetics of~     anthocyanin in healthy volunteers.~   "
61606|NCT02760498|"~     To estimate the clinical benefit of REGN2810 monotherapy for patients with metastatic (nodal~     or distant) cutaneous squamous cell carcinoma (CSCC) (Groups 1 and 3) or with unresectable~     locally advanced CSCC (Group 2), as measured by overall response rate (ORR), according to~     central review.~   "
61607|NCT02760485|"~     The purpose of this study is to evaluate the safety/tolerability and efficacy of itacitinib~     in combination with ibrutinib in subjects with relapsed or refractory diffuse large B-cell~     lymphoma (DLBCL)~   "
61624|NCT02760264|"~     The purpose of this study is to determine whether a new medication called vamorolone is safe~     and well-tolerated by boys with Duchenne muscular dystrophy (DMD) ages ≥ 4 and < 7 years old.~   "
61812|NCT02757820|"~     The aim of this randomized trial will be to evaluate the clinical performance of the I-gel,~     air- Q ILA compared with the LMA classic in pediatric patients undergoing peripheral surgery~     under general anesthesia.~   "
61813|NCT02757807|"~     The aim of this study is to determine if patients with ED taking PDE5 inhibitors (e.g.~     Viagra, CIalis, Levitra, Stendra) and experiencing performance anxiety will benefit using a~     user-friendly stress reducing phone app, Serenita. The study is internet based with no office~     visits.~   "
61608|NCT02760472|"~     Most fatty acids, important for development and especially the Omega-3 fatty acids for the~     brain development are transferred in the third trimester with means that in the premature~     infant this transport via the placenta is interrupted and the infant is dependent on the~     concentrations in breast milk which vary depending on the mother's diet and her stores. It~     has even been suggested that low Omega-3 would be a cause of premature delivery. Many~     countries have much higher levels of Omega-3 fatty acids in breast milk than found in Sweden~     and breast milk substitutions are generally now supplemented with the Long Chained Poly~     Unsaturated Fatty Acids (LCPUFA). Therefore the supplementation to be given can not be seen~     to give any risks for the infant. On the contrary, several studies have shown that mother who~     eat equal to or less than twice fish a week during pregnancy give birth to infants with~     impaired development.~      Low Omega-3 levels in premature infants between gestational ages of 23 and 40 weeks can be~     one reason for Retinopathy of Prematurity (ROP) development. Restoration of Omega-3,~     Dokosahexaenacid (DHA) and Eikosapentaenacid (EPA) to normal in utero levels may prevent ROP~     by allowing normal vessel growth and survival. An increase of Omega-3 levels bringing levels~     to within physiological range may prevent development of ROP.~   "
61609|NCT02760459|"~     To compare the effects of perioperative intravenous Dexamethasone with a placebo on the~     severity of persistent postsurgical pain after total knee arthroplasty.~   "
61610|NCT02760446|"~     Validity and Reliability of French Version of the Confusion Assessment Method for the~     Intensive Care Unit (psychometric validation study after translation/back translation process~     assessed by the original team : W.Ely, MD, Ph.D, Vanderbilt University)~   "
61611|NCT02760433|"~     The purpose of this study is to determine how safe and effective the study drug Olokizumab~     is, in patients with Rheumatoid Arthritis (RA) who are already receiving, but not fully~     responding to treatment with an existing medication called a tumour necrosis factor alpha~     inhibitor~   "
61612|NCT02760420|"~     The purpose of this study to assess the effectiveness of no antibiotic treatment for fast~     breathing, community-acquired childhood pneumonia in a malaria-endemic region of Malawi.~   "
61613|NCT02760407|"~     The purpose of this study is to determine how safe and effective the study drug Olokizumab~     is, in patients with Rheumatoid Arthritis (RA) who are already receiving, but not fully~     responding to treatment with methotrexate (MTX).~   "
61614|NCT02760394|"~     Hyperbaric oxygen therapy (HBOT) is proposed as a possible in vivo angiogenic stimulator for~     improving microvascular myocardial perfusion and anginal symptoms as assessed by myocardial~     perfusion imaging and angina questionnaire in patients with chronic stable ischemic heart~     disease, when no other means to relief symptoms and/or ischemia are available.~   "
61615|NCT02760381|"~     Adenomas and hyperplastic polyps are polypoid lesions that can occur in any part of the~     colon. Currently all polyps should be resected endoscopically, however adenomas have the~     potential to develop into colorectal cancer whereas hyperplastic polyps do not. This approach~     enables the lesions to be evaluated under the microscope. Currently only the pathological~     diagnosis can distinguish exactly between adenomas and hyperplastic polyps. Acetic acid (AA)~     chromoendoscopy is already widely used in order to improve optical determination of mucosal~     lesions in the upper gastrointestinal tract. In the colon only few studies investigated the~     impact of AA in differentiating normal mucosa from suspicious mucosa. The aim of the present~     study is to evaluate the value of spraying acetic acid as an adjunct for optical~     characterization of colon polyps. Using AA may be beneficial for determining optical~     diagnoses of colon polyps during real time colonoscopy. This is a single-arm proof of~     principle study. If colon polyps are found during colonoscopy a 1.5 percent AA solution will~     be used for chromoendoscopy. Endoscopists are encouraged to use the Narrow Band Imaging (NBI)~     function of the endoscope prior to the use of AA. After AA is sprayed endoscopists will~     diagnose the polyp optically. Endoscopists have to predict adenomatous or non-adenomatous~     histology based upon optical features of the polyp. All polyps will be resected~     endoscopically so that histopathological diagnoses can be determined. After completing the~     trial the investigators aim to compare optical and histopathological-based diagnoses of~     polyps. Histopathological diagnoses will serve as the gold standard. Based upon this~     information the accuracy of the optical diagnoses will be calculated. The investigators~     hypothesis is, that optical-based diagnosis using NBI and AA will be accurate in > 75% of all~     polyp cases.~   "
61616|NCT02760368|"~     The purpose of this study is to determine how safe and effective the study drug Olokizumab~     is, in patients with Rheumatoid Arthritis (RA) who are already receiving, but not fully~     responding to, treatment with methotrexate (MTX).~   "
61617|NCT02760355|"~     In this pilot study, the investigators plan to treat patients with chronic hepatitis C due to~     HCV genotype 3 infection using an interferon-free regimen consisting in the administration of~     ribavirin and sofosbuvir/ledipasvir - a combination of a nucleotide RNA polymerase inhibitor~     with a non-structural protein 5A inhibitor. Patients will undergo a euglycemic~     hyperinsulinemic clamp, using tracers, and indirect calorimetry to assess whether the viral~     suppression induced by this regimen will be capable of reversing the glucose metabolic~     alterations induced by HCV in both the liver and extrahepatic compartments. Adipose and~     muscle tissue biopsies will also be performed to assess some specific molecular changes~     induced by HCV.~   "
61618|NCT02760342|"~     The objective of this study is to evaluate the pharmacokinetic interactions between ASP015K~     and metformin in healthy non-elderly male subjects.~   "
61619|NCT02760329|"~     The NOVEL Observational longiTudinal studY (NOVELTY) is an observational study of obstructive~     lung disease and is a multi-country, multi-centre, prospective, longitudinal cohort study~     which will recruit patients with a diagnosis, or suspected diagnosis, of asthma and/or~     Chronic Obstructive Pulmonary Disease (COPD). Patients will undergo clinical assessments and~     receive standard medical care as determined by their treating physician. Patients enrolled in~     NOVELTY will be followed up yearly by their treating physician for a total duration of three~     years. In addition, patients will be followed up remotely every 3 months. The NOVELTY study~     will collect data currently lacking to allow for multinational data collection to fill~     regional/local gaps and improve comparability across regions.~   "
61620|NCT02760316|"~     A study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple~     ascending doses of AZD9567.~   "
61621|NCT02760303|"~     Adolescence and young adulthood may be particularly stressful developmental periods due to~     the numerous transitions into new roles and the need for increased independence. Stress can~     affect metabolic control in older adolescents and young adults with T1D directly through its~     impact on cortisol and other hormones that affect insulin metabolism.~      The proposed study is a pilot randomized clinical trial using a three-group randomized,~     repeated measures design to assess the efficacy of two treatments (Mindfulness Based Stress~     Reduction (MBSR) and Cognitive Behavioral Therapy or (CBT) versus an attention control~     condition for older adolescents and young adults with poorly controlled Type 1 diabetes. As a~     pilot study, the goal of the research is to test recruitment and retention procedures,~     finalize intervention measures, training, and fidelity protocols, and estimate effect sizes~     for a larger clinical trial.~   "
61625|NCT02760251|"~     The study aims to investigate immunomodulatory effects of thrombopoietin-receptor Agonist~     (TPO-RA) in patients with primary ITP, who failed first-line therapy or who became intolerant~     to it. It is hypothesized that the early phase of this autoimmune disease may exhibit a~     stronger immunomodulatory potential in response to a stimulus, such as romiplostim. Such a~     process may subsequently be capable to induce regulatory mechanisms or tolerance.~      Romiplostim (a thrombopoietin-receptor agonist, TPO-RA) will be administered subcutaneously~     once weekly over 22 weeks with a starting dose of 1mcg/kg body weight. The dose will be~     adjusted based on platelet counts as described in the summary of Product Characteristics~     (SmPC).~   "
61626|NCT02760238|"~     The mandate of this MPN registry is to collect clinical information, including molecular~     results, from consenting patients with a variety of MPNs at different time points during the~     course of their disease.~   "
61627|NCT02760225|"~     This is a two center, single arm, investigator sponsored trial (IST) with the PET tracer~     89Zr-pembrolizumab to evaluate in vivo whole body distribution of 89Zr-Pembrolizumab in a~     registered indication: locally advanced metastatic melanoma or non-small cell lung cancer~     before Pembrolizumab treatment.~   "
61628|NCT02760212|"~     Fibromyalgia is a common disorder affecting approximately 2% of the Canadian population.~     Patients diagnosed with fibromyalgia commonly present with chronic, widespread pain as well~     as fatigue, depression, mood disturbances, and cognitive symptoms. As a result, fibromyalgia~     has a negative impact on the patient's quality of life, and a negative financial impact for~     them, society, and the healthcare system, through lost wages and delayed diagnosis. Therefore~     a more direct and conclusive method of diagnosis is needed.~      Recently, fibromyalgia diagnosis has been based on the modified American College of~     Rheumatology Preliminary Diagnostic Criteria for fibromyalgia. To assist with diagnosis,~     recent evidence shows that compared to healthy people, people with fibromyalgia present with~     differences on functional MRI (fMRI) whole brain scans, as well as differences in a~     functional blood biomarker challenge test, known as fm/a. The fm/a determines the function of~     the immune system in response to a stimulus, and has been used previously to show that people~     with fibromyalgia have a severely blunted immune response.~      Despite the number of treatment options available, interventions for chronic pain remain~     largely ineffective. In light of its demonstrated effectiveness, safety, and ease of use in~     previous studies, radial shockwave therapy (RSWT) has been selected for inclusion in the~     present study. The main objective of this study is to determine the efficacy and effect of~     RSWT compared to placebo on the symptoms frequently reported in association with~     fibromyalgia. In addition, the fm/a and brain activity associated with pain patterns (fMRI)~     may assist in early diagnosis and prediction of treatment success in patients with~     fibromyalgia.~   "
61629|NCT02760199|"~     AMG 211 is a bispecific single-chain antibody construct of the bispecific T-cell engager~     (BiTE®) class that targets human carcinoembryonic antigen (CEA, CD66e) on (tumor) cells and~     cluster of differentiation 3 (CD3) positive T-cells. AMG 211 is a potentially new targeted~     drug in the treatment of relapsed/refractory gastrointestinal adenocarcinoma, since those are~     CEA expressing tumors. A well-known challenge in current drug development using targeted~     therapies is the high level of heterogeneity of target expression that is present in specific~     tumor types. Radio-labeling of AMG 211 with the positron emission tomography (PET)~     radionuclide Zirconium-89 (89Zr) enables non-invasive imaging and quantification of AMG 211~     distribution in cancer patients. By performing a 89Zr-AMG211 PET scan prior to treatment with~     AMG 211, the uptake of the tracer in the primary and metastatic tumor lesions and normal~     organ distribution can be evaluated. By performing a 89Zr-AMG211 PET scan during AMG 211~     continuous intravenous (cIV) treatment the investigators will be able to evaluate the impact~     of prolonged steady state exposure of AMG 211 on tumor and tissue uptake. The 89Zr-AMG211 PET~     imaging study may help to identify patients more likely to benefit from AMG 211 therapy.~   "
61630|NCT02760186|"~     Prospective interventional trial in lowlanders evaluating effect of acute exposure,~     acclimatization and re-exposure to high altitude.~   "
61631|NCT02760173|"~     The long-term goal of this research is to advance our knowledge of how the brain combines the~     information of multiple sensory systems coding for spatial orientation and how adaptation to~     vestibular imbalance influences spatial orientation. In healthy human subjects verticality~     perception is accurate while upright. After prolonged roll-tilt, humans show a systematic~     bias in perceived direction towards the previous roll-tilted position (so-called post-tilt~     bias). Here we evaluate different potential explanations for this bias using both~     vision-dependent and vision-independent paradigms of verticality perception.~   "
61632|NCT02760160|"~     To assess the effect of orally administered grape powder on the sunburn reaction in humans.~   "
61633|NCT02760147|"~     The aim of this study is to evaluate the ventilator settings advice given by the BEACON care~     system in fitting with best level of support in patient under mechanical ventilation in~     Pressure Support mode.~   "
61634|NCT02760134|"~     Percutaneous nephrolithotomy (PCNL) is a well-established treatment modality for renal~     stones. It offers a high stone free rates and less invasive than open surgery. Nevertheless~     PCNL is an invasive and technically demanding procedure with inherent risks and~     complications. The most troublesome morbidities are bleeding and injury to the kidney and its~     adjacent structures. Complications of PCNL tend to be associated with the accuracy of tract~     placement and the size of the nephrostomy tract. To improve the safety of PCNL, there is a~     trend toward using smaller and smaller nephrostomy tracts . With the smaller nephrostomy~     tract, there also arise the problems of compromised visual field and increased difficulty in~     stone extraction. Increase irrigation using pressure pump might improve the visualization and~     the passive egress of the stone fragments, but it also may concomitantly increase the~     intra-luminal pressure.~      The present system of Super-Mini percutaneous nephrolithotomy (SMP) was developed to address~     many of these deficiencies. The basic components of SMP system are an 8.0 F miniaturized~     nephroscope with a newly designed irrigation-suction sheath with enhanced irrigation~     capability and modified nephrostomy sheath with continuous negative pressure aspiration. Its~     design was intended not only to prevent the excessive intrarenal pressure but also improve~     the visualization and the stone fragments extraction.~      Little was known about renal pelvic pressure in vivo during SMP and about any correlation it~     might have had with postoperative fever and urosepsis. We measure the renal pelvic pressure~     during SMP to determine whether it will improve the renal pelvic pressure and improve the~     incidence of postoperative fever.~   "
61635|NCT02760121|"~     The purpose of this proposal is to compare the physiological effects of acetazolamide (AZ)~     and methazolamide (MZ) on the control of breathing and hypoxic pulmonary vasoconstriction.~     The first objective is to assess the effects of AZ and MZ on the control of breathing in~     normoxia and hypoxia. To achieve this the ventilatory interaction between oxygen and carbon~     dioxide will be measured and effects compared between placebo, AZ, and MZ conditions. In~     addition, the isocapnic and poikilocapnic hypoxic ventilatory response and hypercapnic~     ventilatory response will be measured with each drug. The second objective is to assess the~     effects of AZ and MZ on the control of the pulmonary vasculature during hypoxia. Pulmonary~     pressure and cardiac output will be measured during 60 minutes of poikilocapnic hypoxia.~   "
61636|NCT02760108|"~     One person in every 500 has Parkinson's and around 127,000 people are living with the~     condition in the UK. The aim of the study is to identify new genes that predispose or cause~     Parkinson's Disease or Parkinsonism. There is a pressing need to study the genetic makeup of~     family members both with and without Parkinson's. As families share a common genetic~     background, it is easier to find new Parkinson's genes by studying the genetic makeup of~     people with Parkinson's alongside other members of their families. We are particularly~     interested in studying the genetic makeup of two groups of people:~        1. those who developed Parkinson's before the age of 45; and~        2. those who have a family history of other relatives affected by Parkinson's.~      By identifying genetic factors that cause Parkinson's, we hope to understand more about the~     condition. Doing so will lead to the development of better diagnosis, improved disease~     models, and we hope in time, to the development of better treatment.~   "
61637|NCT02760095|"~     The overall objective is to determine the impact of EED on zinc absorption and homeostasis,~     and its impact on the absorptive capacity of vitamin A absorption of young children (18-24~     months of age) in an austere setting with high rates of diarrhea, stunting, and~     micro-nutrient deficiencies.~   "
61638|NCT02760082|"~     The study will based on qualitative methods investigate motivational factors among patients~     diagnosed with multiple sclerosis for registering nutrition, environmental factors, stress~     provoking factors and physical activity (NESPA). The aim is to gain knowledge on motivational~     factors for using a digital tool for collecting data on NESPA and incorporate this knowledge~     into a form which can be used in requirement specifications for such a digital tool.~   "
61639|NCT02760069|"~     This study will compare the efficacy of isopropyl alcohol and conventional anti-emetics with~     three study arms: (1) inhaled isopropyl alcohol plus oral ondansetron; (2) inhaled isopropyl~     alcohol plus oral placebo; (3) inhaled placebo plus oral ondansetron.~   "
61640|NCT02760056|"~     This is a phase 1 study evaluating the safety and maximum tolerated dose of Liothyronine (T3)~     in subjects with multiple sclerosis~   "
61641|NCT02760043|"~     This study will evaluate if the addition of dexamethasone to a local infiltration analgesia~     mixture will improve functional outcomes following total hip and knee arthroplasty.~   "
61642|NCT02760030|"~     This phase II clinical trial studies how well fulvestrant and palbociclib works in treating~     older patients with breast cancer that responds to hormone treatment (hormone responsive)~     that cannot be removed by surgery. Estrogen can cause the growth of~     estrogen-receptor-positive breast cancer cells. Hormone therapy using fulvestrant may fight~     estrogen-receptor-positive breast cancer by blocking the use of estrogen by the tumor cells.~     Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth. Giving fulvestrant together with palbociclib may be an effective treatment for~     hormone responsive breast cancer.~   "
61643|NCT02760017|"~     Among the plants most used in folk medicine for the treatment of diabetes are the species of~     the genus Bauhinia (Fabaceae), popularly known in Brazil as pata-de-vaca. Of these,~     Bauhinia forficata has the highest number of studies regarding the hypoglycemic activity. Due~     to this fact it is included in the Medicinal Plants List of the Brazilian Public Health~     System. Extracts of pata-de-vaca (B. forficata) have been explored both in relation to its~     chemical composition and its pharmacological potential. From the chemical point of view the~     main components identified in hydro alcoholic extract of the leaves are O-glycosylated~     derivatives of kaempferol and quercetin. Regarding pharmacological properties preclinical~     studies have confirmed the hypoglycemic effect and antidiabetic of the hydroalcoholic extract~     of the leaves of B. forficata. The search for evidence of the alleged anti-diabetic activity~     of B. forficata in clinical level was performed in only two studies, both with few patients,~     and questionable methodological quality that used tea as a pharmaceutical form, a fact that~     allows us to question the validity of data considering the risks of no dose reproducibility~     ingested by patients during the study. Thus the investigators here intend to determine the~     effects of a standardized extract of B. forficata in the control of patients with diabetes~     mellitus~   "
61644|NCT02760004|"~     The primary goal of this study is to develop, evaluate, and share a new low-cost program for~     Obstetrics/Gynecology (Ob/Gyn) practices which will help to improve depression treatment for~     women during pregnancy and after childbirth.~   "
61645|NCT02759991|"~     The aim of the study is to determine the effectiveness of hepatitis E virus vaccine given in~     women of child bearing age in preventing HEV disease during pregnancy among women in rural~     Bangladesh.~   "
61646|NCT02759978|"~     Infective endocarditis (IE) is a frequent and serious complication of implanted intracardiac~     prosthetic material, with a high morbidity and mortality. Therefore, this study aims to~     improve outcome of IE, with a focus on patients with intracardiac prosthetic material. In~     this study the investigators deal with research questions about both the diagnosis~     (microbiological, imaging, and expert opinion) and treatment of IE (with antimicrobial agents~     and surgical), in order to improve these clinical components and ultimately aim to improve~     outcome.~   "
61647|NCT02759965|"~     The primary hypothesis that orthopaedic surgery induces a neuroinflammatory response within~     48 hours after elective hip surgery and that there is an association between exaggerated CNS~     inflammatory response or impaired inflammatory resolution and postoperative cognitive~     dysfunction within one week and at three months postoperatively.~   "
61648|NCT02759952|"~     Mutations in the PDE6A gene - encoding the -subunit of the rod cGMP-phosphodiesterase -~     account for 1% of autosomal recessive retinitis pigmentosa (arRP) through impaired regulation~     of cGMP levels in the rod outer segment. This study aims for a detailed clinical~     characterization of patients with PDE6A mutations in preparation of a clinical gene~     replacement study (phase I/II safety trial).~   "
61649|NCT02759939|"~     Right For Me is a study that aims to improve the conversations patients and health care~     providers have about birth control. Right For Me will test two different strategies for~     improving these conversations. The first strategy is to give patients a video to watch that~     encourages them to ask three specific questions in their health care visit, as well as a~     prompt card that reminds them of the three questions. The second strategy is to give health~     care providers a set of decision aids that describe available birth control methods, as well~     as training in how to use them with patients during the health care visit. Right For Me will~     test whether introducing one or both of these strategies leads to better conversations than~     providing health care as usual.~   "
61650|NCT02759926|"~     In this study, the investigators aimed at evaluating the role of bitter taste receptors in~     the gastrointestinal tract (GIT). Intragastric or intraduodenal administration of denatonium~     benzoate (DB) or quinine hydrochloride were compared with placebo administration for their~     effects on lingual sensitivity, gastrointestinal motility (both in the fasted and fed state),~     gut hormone release (motilin, ghrelin, glucagon-like peptide-1 (GLP-1) and cholecystokinin~     (CCK)) and food intake. Differences between lean and obese subjects will be evaluated.~   "
61651|NCT02759913|"~     Prospective multicenter study of subjects who were recently diagnosed with amyotrophic~     lateral sclerosis (ALS) or another neurodegenerative disease (including spinal cord diseases,~     muscle diseases and neurological diseases such as multiple sclerosis, multifocal motor~     neuropathy, myasthenia gravis and spinal muscular atrophy) or who are currently undergoing~     diagnostic procedures for the aforementioned diseases.~      Approximately 300 subjects will be enrolled. Subjects will undergo a lumbar puncture (LP) for~     cerebro-spinal fluid (CSF) collection; blood collection for serum, plasma, RNA, and DNA~     (optional); urine collection (optional); and skin biopsy (optional) in a single visit. No~     study treatment will be administered.~      Subjects will be managed and treated by their respective physicians; choice of therapy or~     laboratory tests will not be impacted by the study. Clinical diagnosis may be confirmed by~     the subject's physician and communicated to the study's Principal Investigator (PI) by~     scheduled telephone calls.~   "
61652|NCT02759900|"~     This study examines the efficacy of a non-thermal, atmospheric plasma device in the treatment~     of a number of different skin disorders~   "
61653|NCT02759887|"~     In order to treat individuals with Down syndrome (DS) better and more efficiently and to gain~     more insights on its relation to Alzheimer's disease (AD), a comprehensive understanding is~     needed for its progression in the early or preclinical phase using various biomarkers. DS is~     a significant risk factor for the early development of AD, with plaques and tangles typically~     developing by age 35. A better understanding is needed of early markers of the disease in DS~     patients. Additionally the DS population represents a unique group - due to this elevated~     risk for AD - to examine biomarkers that may translate in general outside of the DS~     population to individuals at risk for developing late onset AD. In this proposal, the~     researchers will assess the longitudinal changes of various biomarkers in a cohort of~     individuals similar in design to the cross-sectional sectional study in the preliminary data.~   "
61654|NCT02759874|"~     The Institute of Health Economics is conducting a study to determine how a breathalyzer~     linked to a cloud based alcohol monitoring system changes alcohol consumption during~     pregnancy in women with alcohol dependency issues.~      IHE posits that the ability to self-monitor blood alcohol concentration and the ability to~     share sobriety via email or text with loved ones and counselors may reduce alcohol~     consumption and thus reduce the possibility of delivering a child with FASD.~      The study will provide useful evidence for tailoring future optimal maternal and child~     healthcare for women, with the potential of decreasing healthcare utilization by prevention~     of FASD. Breathalyzer device usage plus secure document sobriety should improve patient~     monitoring convenience and demonstrate reductions in alcohol use outside of traditional~     office visits and patient self-reports.~   "
61655|NCT02759861|"~     To determine the efficacy and safety of Harvoni in treatment-naïve alcoholic subjects with~     Genotype 1 HCV infection~   "
61656|NCT02759848|"~     Influence of tuberculosis (TB) on natural course of chronic obstructive lung disease (COPD)~     has not been well known. This study was designed to investigate the effects of history of TB~     on the long-term course of COPD.~   "
61657|NCT02759835|"~     Background:~      Some non-small-cell lung cancers (NSCLC) have a mutation in a gene that makes a protein~     called EGFR. This particular cancer can be treated with certain drugs such as Erlotinib~     (Tarceva), Gefitinib (Iressa) and Osimertinib (Tagrisso). But many tumors become resistant to~     these drugs because of a second mutation. Researchers want to test if adding local ablative~     therapy (LAT) extends the benefits of the drug, Osimertinib. LAT can include techniques such~     as surgery, radiofrequency ablation, cryotherapy or radiation therapy.~      Objective:~      To test if re-taking osimertinib after LAT is safe, tolerable, and effective for people whose~     NSCLC has progressed after initial treatment with osimertinib.~      Eligibility:~      Adults ages 18 and older with certain types of NSCLC. Participants will be divided into~     various groups as described below.~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Blood, urine, and heart tests~      Tumor scans~      Eye exam~      Review of tumor sample.~      Participants will take the study drug by mouth once a day. They will continue until they can~     no longer tolerate it or their disease worsens. They will keep a dosage diary.~      All participants will start each 21-day course with physical exam; blood, urine, and saliva~     tests; and electrocardiogram. They will have scans every 6 weeks and echocardiogram every 3~     months.~      Groups 1 and 2 will:~      Start osimertinib right away.~      Have LAT if their disease gets worse and is suitable for LAT. If LAT cannot be performed or~     LAT consists of a procedure other than surgery, a tumor biopsy will be performed.~      Re-start osimertinib after LAT, or other treatments if not suitable for LAT.~      Group 3 will:~      Have LAT.~      If LAT consists of a procedure other than surgery, a tumor biopsy will be performed.~      Start osimertinib after LAT.~      After participants stop taking the drugs, they will have a final visit. This will include:~      Medical history~      Physical exam~      Heart and blood tests~      Participants will be called every year for follow-up.~   "
61658|NCT02759822|"~     This is a prospective observational cohort study of haploidentical transplantation with~     post-transplant cyclophosphamide for acute leukemias using reduced intensity conditioning for~     acute myeloid leukemia (AML) and myeloablative conditioning for acute lymphoblastic leukemia~     (ALL).~   "
61659|NCT02759809|"~     In Canada, the leading cause of long-term disability in children is being born at very low~     birth weight (VLBW). To help improve outcomes, nutrition is a modifiable aspect of infant~     care. Mother's milk is the optimal way to feed VLBW infants; however, many need a supplement~     of donor milk or preterm formula as not enough mother's milk is available. As the ideal~     supplement for prolonged feeding and its long-term effects is currently unknown, this study~     is a prospective follow up of VLBW infants who in hospital were fed: donor milk or preterm~     formula and/or mother's milk. Areas of development to be assessed include: cognition,~     language, motor skills, brain structure/function, and body composition. A DNA biorepository~     will also be created.~   "
61660|NCT02759796|"~     It is a single-center, prospective, randomized and controlled study focused in microsurgical~     autologous breast reconstruction. It involves applying indocyanine green (ICG) angiography~     for the study of the vascularization of DIEP flaps. The aim of the study is to determine~     whether there are differences in complications and aesthetic results when ICG is used to~     discard the poorly vascularized areas of the flap. The study includes adult women undergoing~     unilateral DIEP flap breast reconstruction. The calculated sample size is 60 patients. There~     are two groups. In group 1, the investigators use the usual clinical criteria to discard the~     poorly vascularized areas of the flap. In group 2, the investigators use the ICG to shape the~     flap.~   "
61661|NCT02759783|"~     Metastatic spread of cancer from its primary site to distant organs is the commonest cause of~     death from cancer. The term oligometastases describes an intermediate metastatic state, in~     which cancer exists as a limited number of metastases at first, before cells acquire the~     ability to metastasise more widely. For the large majority of solid cancers, once metastatic~     disease has been diagnosed the chances of cure are small. There are several situations where~     this is not the case, but it is not known if stereotactic body radiotherapy (SBRT) for~     oligometastatic disease will alter outcomes or whether the toxicity burden of this treatment~     is justified. SBRT is targeted radiotherapy which destroys cancer cells in the area of the~     body it is aimed at however low dose radiation may be received by surrounding tissue.~      It is difficult to quantify incidence of patients with multiple primary cancers developing at~     intervals that are representative of oligometastatic stage IV disease, (defined for the~     purposes of this trial as ≤ 3 metastatic sites). However an increase in the use of~     surveillance imaging, together with improved diagnostic sensitivity has led to the diagnosis~     of patients with asymptomatic oligometastatic relapse becoming a more common clinical~     occurrence. The CORE study is a randomized controlled trial that will be conducted in~     patients with cancer in one of three primary sites where oligometastatic disease relapse is a~     common clinical scenario: breast, prostate and non-small cell lung cancer (NSCLC). The study~     will evaluate the use of SBRT in this patient population.~      Eligible patients who consent to participate in this clinical trial will be randomized to~     receive standard care or standard care plus SBRT we hope to recruit approximately 206~     patients to the study and the primary outcome measure is progression free survival.~   "
61662|NCT02759770|"~     Acute respiratory distress syndrome following cardiac surgery severely affects the prognosis~     of patients; the mortality is up to 40%. Although experience many years of research and~     exploration, the effective methods for the treatment of acute respiratory distress syndrome~     is still relatively limited at present, including lung protective mechanical ventilation~     respiratory support, fluid management, glucocorticoid and other integrated organ function~     maintenance measures. It is currently the research of acute respiratory distress syndrome~     aims at the early discovery and takes effective measures to prevent its occurrence, hoping to~     improve the prognosis of patients. According to risk factors is established through the~     analysis of lung injury score early warning system, the early identification of acute~     respiratory distress syndrome patients at high risk, before the occurrence of acute~     respiratory distress syndrome take corresponding preventive measures can effectively reduce~     the incidence rate and mortality. So far, domestic and foreign research on the establishment~     of acute respiratory distress syndrome scoring early warning system is less. Cardiac surgery~     has significant characteristics, type of operation, location, operation, intraoperative blood~     transfusion and oxygenation, postoperative factors, are likely to be the factors of acute~     respiratory distress syndrome. As far as investigators know, so far there are few specialized~     for acute respiratory distress syndrome predicting lung injury after cardiac surgery. This~     study will be completed after the implementation of individualized dynamic lung injury score~     evaluation of cardiac surgery patients, identification of high-risk acute respiratory~     distress syndrome patients, to assist clinicians in early decision, take preventive measures.~     This study will improve the prognosis of acute respiratory distress syndrome patients after~     cardiac surgery; it is of great significance to improve the level of intensive care after~     cardiac surgery.~   "
61663|NCT02759757|"~     Objectives: To test if the Kinesio Tex Gold ® is able to change the electromyographic signal~     of iliocostalis and longissimus muscles in patients with chronic nonspecific low back pain.~      Study design: Three-arm, randomized controlled trial with a blinded assessor.~      Location of study: Physical therapy Clinic of the Universidade Cidade de São Paulo (UNICID)~      Patients: Sixty-three patients with chronic nonspecific low back pain.~      Intervention: Patients allocated to the Kinesio Taping® group will receive the tape as~     described by the manufacturer's manual. The patients assigned to the placebo group will~     receive a Micropore tape and the control group will not receive any intervention. All groups~     will be assessed before and 30 minutes after intervention~      Measures: The following outcomes will be measured: 1) Muscle activity and 2) pain intensity.~      Limitations: Therapists will not be blinded.~   "
61664|NCT02759744|"~     Background:~      Prostate cancer is the most common non-skin cancer in U.S. men. Treatments for early or less~     aggressive disease are limited. Researchers want to test a device that destroys cancerous~     tissue with laser energy. They want to see if using it with ultrasound is more comfortable~     than using it with magnetic resonance imaging (MRI).~      Objectives:~      To test a cooled laser applicator system to treat prostate cancer lesions. To see if~     ultrasound imaging is a practical and feasible treatment with laser ablation for focal~     prostate cancer treatment.~      Eligibility:~      Men at least 18 years old with prostate cancer seen on MRI that has not spread in the body.~      Design:~      Participants will be screened with standard cancer care tests. These can include physical~     exam, lab tests, and MRI. For the MRI, they lie in a machine that takes pictures.~     Participants will have a prostate biopsy. Needle samples will be taken from 12 places in the~     prostate. This will be guided by MRI and ultrasound, which is obtained through a coil in the~     rectum.~      Participants will stay at the clinic for 1 2 days. A cooling catheter (plastic tube) will be~     put in the bladder. Ultrasound will guide the laser applicator directly to the tumor.~      The cooling catheter will be removed. A different catheter will be put in the urethra to keep~     the bladder emptied.~      The next day, participants will have a physical exam and a PSA blood test.~      Participants will have 6 follow-up visits over 3 years. At each visit, they will have a~     physical exam and lab tests. At some visits, they will also have an MRI or other scans and a~     prostate biopsy.~   "
61682|NCT02759510|"~     Since 2011, phenylephrine was recommended as the preferred drug to maintain blood pressure in~     obstetric anesthesia.Phenylephrine, an α adrenoceptor agonist, can induce peripheral~     vasoconstriction to maintain blood pressure, while reflexly decrease heart rate and result in~     cardiac output (CO) reduction.Norepinephrine acts not only as an α adrenoceptor receptor~     agonist, but also as a weaker β adrenergic receptor agonist. It can elevate blood pressure~     the same asphenylephrine, meanwhile produce positive inotropic effect including increasing~     heart rate.Thus, the administration of norepinephrine can maintain blood pressue and avoid~     the decline of CO. The purpose of this study is to evaluate the effect of norepinephrine and~     phenylephrine on maternal CO in cesarean section by transesophageal echocardiography.~   "
73095|NCT02610179|"~     The goal of this prospective study is to determine whether there is superiority of 10~     Twizzlers to the 50 gram glucola beverage for screening for GDM in a population based study.~   "
61665|NCT02759731|"~     Background:~      Chronic graft versus host disease (cGVHD) can affect people who had a hematopoietic stem cell~     transplant using donor cells. It is often fatal. It is usually treated with high doses of~     steroids. But that helps only about half the people in the long term. Researchers want to see~     if a drug called baricitinib can help people with cGVHD that has not responded to therapy.~     The drug inhibits the proteins involved in communication in the immune system. These proteins~     may play a role in cGVHD and other inflammatory diseases.~      Objectives:~      To test the safety and effectiveness of baricitinib in people with cGVHD that has not~     responded to therapy.~      Eligibility:~      Adults 18 and older with cGVHD that has not responded to therapy.~      Design:~      Participants will be screened with a medical history, physical exam, and blood and urine~     tests. They will have lung and heart tests and chest scans.~      Baseline visit: Participants will have:~      Medical history~      Physical exam~      Blood tests~      Tests for infectious diseases~      Skin, eye, and teeth evaluations~      Rehabilitation and occupational medicine evaluations~      Photos of any lesions~      Gynecology evaluation (females)~      The study will occur in 28-day cycles. Participants will take the study drug by mouth every~     day for 3 cycles. Some will take it for 3 or 6 more cycles.~      Participants will have a few visits during each cycle. They will repeat some previous tests.~     They may also have scans and questionnaires.~      Participants will have a visit when they stop taking the drug and another 3 months later.~     They will repeat a few study tests. They will have follow-up calls for 2 years.~   "
61666|NCT02759718|"~     Chromogranin A (CgA) is a glycoprotein with a molecular weight of 49 to 52 kDa produced by~     chromaffin cells of the adrenal medulla, enterochromaffin-like (ECL) cells, and endocrine~     cells of the stomach and pancreas, and it is the precursor to several functional peptides~     including vasostatin and pancreastatin.~      Importantly, CgA can be measured in the serum or plasma or detected within the secretory~     vesicles as a general diagnostic biomarker for neuroendocrine tumors (NETs), and plasma CgA~     levels also provide information regarding tumor burden and response to treatment. It has a~     sensitivity and specificity between 27% and 81%.~      Some studies have noted an association between CgA concentrations and tumor location or~     degree of differentiation. It has also been proposed that plasma CgA levels are more~     frequently elevated in well-differentiated tumors compared with poorly differentiated tumors~     of the midgut. Some other clinical series have provided evidence of an association between~     plasma CgA levels and the extent of disease, tumor burden, or presence of metastases, and~     high baseline levels of CgA are suggestive of a poor prognosis.~      However, there exist still controversies the effectiveness of serum CgA levels on diagnostic~     relevance, treatment response after surgical resection or sandostatin analog,~     clinicopathologic features of pancreatic neuroendocrine tumors (PNETs).~      To date, moreover, a precise association between CgA levels and survival has not been clearly~     demonstrated, although a number of studies suggest that this relationship may exist. There,~     especially, is no relevant data on value of serum CgA level for clinical usefulness in Korean~     population.~   "
61667|NCT02759705|"~     This analytical descriptive study aims to describe the fertility and sexuality male adult~     subjects carrying classic bladder exstrophy or epispadias and to highlight infertility risk~     factors. A questionnaire on paternity, urinary status, erections, ejaculations and sexual~     self-esteem and a semen analysis will be realized at first consultation, semen analysis~     results wil be explained at second consultation. It is assumed that fertility and sexuality~     exstrophic men are impaired.~   "
61668|NCT02759692|"~     Adaptive, randomized, subject-masked, dispensing study to evaluate the short-term, clinical~     performance of two FDA-approved contact lens.~   "
61669|NCT02759679|"~     The study aims to optimize and define a reproducible and non-invasive method for canine~     assisted lung cancer detection, using human breath samples from patients and controls for~     training and testing purposes.~   "
61670|NCT02759666|"~     This is an open-label, multicenter, non-randomized, dose-escalation phase 1 trial to evaluate~     the safety and tolerability of SHR3162 in participants with advanced solid tumors.~   "
61671|NCT02759653|"~     BACKGROUND: In 30-40% the cause of ischemic stroke remains undetermined. Most likely, this~     category hides an additional number of strokes caused by artery-to-artery embolisms due to~     unidentified atherosclerotic disease, or caused by cardioembolism. Both types are associated~     with a high risk of recurrent ischemic events and multiple cerebral infarctions.~      Large-artery atherosclerosis of the brain-supplying arteries is the assumed underlying cause~     in 10 to 15% of ischemic stroke, mostly deriving from the extracranial carotid artery.~     Carotid intima-media thickness (cIMT) measured by 2-dimensional (2D) B-mode ultrasonography~     and estimation of the overall atherosclerotic plaque burden aids future risk prediction.~     Arterial wall changes, artery caliber variations, degree of stenosis, local hemodynamic~     alterations and certain plaque characteristics are important for the evaluation of plaque~     vulnerability and vascular risk stratification. Transcranial Doppler monitoring (TCDM) is a~     non-invasive bedside examination eligible for detection of microemboli in the human cerebral~     circulation.~      HYPOTHESIS: Atherosclerotic stenosis and plaque characteristics can be more accurately~     assessed by the combination of routine 2D ultrasound, contrast enhanced ultrasound (CEUS),~     and 3-dimensional (3D) ultrasound. TCDM, CEUS and 3D visualization of the carotid plaque~     improve the differentiation of stroke etiology and quantification of plaque vulnerability,~     and aid the prediction of future risk for cerebrovascular events in the individual patient.~      AIMS: Assessment of prevalence and frequency of Microemboli signals (MES) in unselected~     patients with cerebral ischemia, the influence of antithrombotic drugs on MES, and the~     relationship between MES and recurrent stroke or Transient ischemic attack (TIA).~      Categorization of atherosclerotic carotid artery disease by use of routine and advanced~     neurosonographic techniques combined with anamnestic and clinical data.~      Development of a visualization solution tailored for 3D visualization of carotid arteries and~     semi-automatic plaque segmentation.~   "
61672|NCT02759640|"~     This is a phase 1, open-label, dose-escalation trial of HS-10241 as monotherapy in subjects~     with solid tumors. HS-10241 will be administered orally once daily.~   "
61683|NCT02759497|"~     One of the most common and serious complications in decompensated cirrhotic patients (DCPs)~     is bacterial infection.The most common infections in DCPs are cases of spontaneous bacterial~     peritonitis (SBP), which account for 40% 70% of cases, followed by urinary tract infections,~     pneumonia and cellulitis.~      Serum amyloid A (SAA) and C-reactive protein (CRP) are acute-phase proteins predominantly~     produced and secreted by hepatocytes. Other cells including lymphocytes, monocytes, and~     macrophages can also produce these proteins. The induction of SAA and CRP synthesis is~     triggered by a number of cytokines, chiefly IL-6, which is released from a variety of cell~     types, but mainly from macrophages and monocytes at inflammatory sites~   "
61838|NCT02757482|"~     The purpose of this study is to examine the effects of patient training about the safety of~     warfarin therapy on related knowledge levels and on International Normalized Ratio (INR)~     control.~   "
61673|NCT02759627|"~     Stroke is one of the major cause of morbidity and mortality and the leading cause of~     disability in adults all around the world. Stroke survivors can suffer several neurological~     impairments and deficits which have an important impact on patient's quality of life and~     which increase the costs for health and social services. After stroke, impairments in ADLs~     and functional status, deterioration in health related quality of life can be seen.~      Although most of the stroke survivors experience some level of neurological recovery, nearly~     50%-60% of stroke patients still experience some degree of motor impairment, and~     approximately 50% are at least partly dependent in activities-of-daily-living (ADL). Gait~     recovery, performing activities of daily living and regaining independence in ADLs are the~     main focus of stroke rehabilitation programs.~      Robotic technologies are becoming more promising techniques for the locomotor training in~     stroke patients. Achieving a functional walking level is one of the target of robotic gait~     training and it has been shown that Robotic-Assisted Gait Training (RAGT) improves walking~     function in stroke patients. Having a functional gait level may help the stroke patients to~     regain independence in ADLs and improve quality of life.~      The purpose of the present study was to investigate the effects of RAGT on functional status,~     ADLs and health related quality of life.~   "
61674|NCT02759614|"~     This is a randomized, open-label, controlled, multicenter, Phase III study. Patients will be~     randomly assigned to treatment group (1:1) through a dynamic randomization process with use~     of the following stratification factors: sex (female/male), disease stage (stage IIIb vs.~     stage IV vs. recurrence), and EGFR gene mutation (exon 19 deletion vs. exon 21 L858R).~   "
61675|NCT02759601|"~     This study is being carried out to assess the best dose of a new drug, called tefinostat, in~     treating liver cancer.~      Tefinostat is a new drug that blocks enzymes called histone deacetylases (pronounced~     dee-as-et-isle-azes). Cells need these enzymes to grow and divide. Blocking them may stop~     cancer growing. Drugs that block these enzymes are called histone deacetylase inhibitors or~     'HDAC inhibitors'.~      Tefinostat has never been given to patients with liver cancer before so it isn't known which~     dose is best at treating liver cancer. To find this out the study will be testing one dose~     and if that is safe, then test a higher dose and so on.~      The aim of this study is to find the best dose of tefinostat without causing side effects.~     The study will be looking closely at any side effects patients might experience from this~     treatment.~   "
61676|NCT02759588|"~     The purpose of this study is to determine if GL-ONC1 oncolytic immunotherapy is well~     tolerated with anti-tumor activity in patients diagnosed with recurrent ovarian cancer and~     peritoneal carcinomatosis.~   "
61677|NCT02759575|"~     The purpose of this research study is to test the safety and the benefit of adding~     pembrolizumab (a therapy that activates the immune system to fight cancer) to standard of~     care treatment for larynx cancer. The standard of care treatment will include chemotherapy~     and radiation for 7 weeks.~   "
61678|NCT02759562|"~     This primary objective of this study is to the effect of andecaliximab (GS-5745) on~     pre-bronchodilator forced expiratory volume in 1 second (FEV1) in adults with cystic fibrosis~     (CF) after 8 weeks of treatment.~      There will be 2 parts to this study. In Part 1, andecaliximab 600 mg or placebo will be~     administered for 8 weeks. In Part 2, andecaliximab 300 mg, 150 mg, or placebo will be~     administered for 8 weeks. Part 2 will be initiated after completion of Part 1.~   "
61679|NCT02759549|"~     The purpose of this study is to determine if an avatar-based depression self-management~     intervention (eSMART-MH) once a week for the duration of the participant's radiation~     treatment will significantly reduce depressive symptoms. Investigators also seek to explore~     how women with breast cancer describe their mood using prompted and unprompted speech through~     electronic social media and interviews.~      Participants will be randomized into the eSMART-MH group or the theater testing (attention~     control) group. In addition to the assigned interventions, participants will be asked to~     complete questionnaires and interviews with the study staff.~   "
61680|NCT02759536|"~     Boron Neutron Capture Therapy (BNCT) has been used in the treatment of several types of~     malignant tumors, including malignant melanoma, high-grade gliomas, and advanced head and~     neck cancers. Theoretically, it represents a more precise radiotherapy in that it could spare~     normal cells while destroy malignant ones. However, its value is largely restricted by the~     fact that it could only be performed in the nuclear research reactors, the only neutron~     source at the time. In 2010, the world's first in-hospital neutron irradiator (IHNI) had been~     constructed in Beijing, China, and this study aims to evaluate whether IHNI has the potential~     to serve as an effective in-hospital neutron source for BNCT.~   "
61681|NCT02759523|"~     Increased portion sizes of foods high in energy density (calories per gram of food) have been~     implicated in the obesity epidemic. Numerous studies show that children and adults eat more~     from larger portions of food than they do from smaller portions, a response known as the~     portion size effect. Despite the robust and consistent nature of these findings, the~     mechanisms underlying the portion size effect are not known. The long-term goal of this~     research is to identify the neural mechanisms involved in the portion size effect so that~     this information can be used to develop effective weight-management strategies. Differences~     in neural response to food cues, as demonstrated by functional magnetic resonance imaging~     (fMRI), can help clarify the factors that determine susceptibility to large portions. The~     goal of this study is to identify brain regions activated in response to portion size and~     energy density and relate these neural responses to laboratory eating behaviors in children.~      The investigators hypothesize that high relative to low energy density food images will be~     associated with increased activation in regions of the brain involved in reward- and sensory-~     processing and that large relative to small portion size food images will be associated with~     increased activation in regions of the brain involved in cognitive control. In addition, the~     investigators hypothesize that these brain responses will influence the relationship between~     portion size served and energy intake at laboratory meals.~   "
61728|NCT02758912|"~     The objective of this study is to evaluate the long-term plasma and urine pharmacokinetic~     parameters of Cardionat®, capsules 250 mg, when used in healthy athlete volunteers.~      The study consists of four steps:~        -  Step 1. Screening - selecting healthy volunteers for inclusion in the study;~        -  Step 2. Assignment in one of the study group, prescription of the study drug;~        -  Step 3. Samples collections for pharmacokinetic analysis;~        -  Step 4. Evaluation of pharmacokinetic data.~   "
61684|NCT02759484|"~     The MATCH2 Study (The Multi-clinic Action Trial to Control Hyperglycemia and Hypertension) is~     a randomized controlled trial comparing two educational approaches to improve glucose and~     blood pressure control in African American and Latino adults with type 2 diabetes. The study~     is being designed and implemented using a Community Based Participatory Research approach to~     optimize the two educational approaches. One approach, Enhanced Home Based Education, adapts~     a Community Health Worker (CHW) intervention from the protocol of the prior Mexican-American~     Trial of Community Health workers (MATCH). The other approach, Enhanced Clinic Based~     Education, uses a Certified Diabetes Educator (CDE) to deliver dietary and general~     self-management education. The study seeks to determine if Community Health Workers working~     as part of the primary care clinical team can reduce health disparities and improve outcomes~     among patients with type 2 diabetes.~   "
61685|NCT02759471|"~     This is a prospective, multi-center, subject-masked, bilateral wear, one month dispensing~     study comparing the clinical performance of the subjects' habitual comfilcon A sphere lens~     (control) following a refit with comfilcon A asphere lens (test). After the dispensing visit,~     subjects will return for follow-up evaluations after 2 weeks, and 1 month.~      Both comfilcon A sphere lens (control) and comfilcon A asphere lens (test) are Coopervison~     lenses.~   "
61686|NCT02759458|"~     The purpose of the proposed study is to evaluate a new anchor for rotator cuff repair, the~     Smith & Nephew Healicoil anchor. This anchor utilizes a small open-construct design to~     promote bone-in growth and potentially allow for the release of bone marrow factors into the~     repair site. In vivo ovine studies comparing the Arthrex BioComposite Corkscrew FT rotator~     cuff anchor to the Arthrex SwivelLock anchor have shown superior bone in-growth.~      Thus, this study consists of three separate aims in order to clinically and biochemically~     investigate the capabilities of the Healicoil anchor and its efficacy in rotator cuff repair.~     One, evaluate the bone in growth of the anchor compared to a standard poly-ether ether ketone~     (PEEK) anchor. Two, analyze the marrow elements that are released into the repair site~     through the open construct. Three, compare the functional outcomes of patients with rotator~     cuff repairs using the Healicoil anchor compared to a traditional Twinfix PEEK anchor.~   "
61687|NCT02759445|"~     Background: Chronic excessive alcohol consumption leads to progressive and chronic cardiac~     dysfunction. In general, patients consuming alcohol more than five years are at risk for the~     development of dilated cardiomyopathy. As only few data about immediate changes in left~     ventricular function after acute excessive alcohol ingestion are available, this study sought~     to close this gap.~      Methods: 200 subjects (not used to alcohol, no cardiac disease) will be examined up to 12~     hours after alcohol excess and after 4 weeks of complete alcohol abstinence. Echocardiography~     will performed at baseline and at follow-up regarding conventional parameter [as left~     ventricular ejection fraction (LVEF), transmitral early (E) and late (A) Doppler flow~     velocities, E/A ratio, deceleration time of E (DT) and isovolumic relaxation time (IVRT)] and~     myocardial deformation data [as layer specific global circumferential (endo GCS, mid GCS, epi~     GCS) and longitudinal (endo GLS, mid GLS, epi GLS) strain].~   "
61688|NCT02759432|"~     Low-volume high-intensity interval exercise training may improve aspects of health and~     fitness in young people, but the effect of this type of exercise on quality of life has yet~     to be assessed. The investigators aim to examine the effect of a 4-week school-based~     low-volume high-intensity interval training programme (called the Fun Fast Interval Training~     [FFIT] activity project) on physical fitness and quality of life in adolescent school pupils.~     Approximately 145 English adolescents aged 11-12 years will be approached and invited to take~     part in the study. Participants will be healthy female volunteers, recruited from one school~     in Northeast England. Using a non-randomised design, one school year group will be assigned~     to take part in the intervention, and a second year group assigned to the control~     condition.Those in the intervention group will complete a 4-week school-based high-intensity~     interval exercise training programme. The intervention will take place twice per week, and~     comprise of 6-8 repetitions of 45 s maximal effort exercise (boxing, running, soccer and~     basketball drills), each interspersed with 90-s rest. Participants will be encouraged to work~     maximally during the 45-s repetitions. Control participants will be instructed not to change~     their lifestyle, dietary or physical activity habits during the intervention period, and~     maintain their normal school physical education routine. Study outcomes will be 20 m shuttle~     run test performance, health-related quality of life, standing broad jump performance, hand~     dynamometer performance, waist circumference and 10 m and 20 m sprint performance.~   "
61689|NCT02759419|"~     To provide riociguat therapy to eligible patients with PAH originating from Bayer-sponsored~     trials with BAY63-2521/ Riociguat / Adempas® who are currently or recently treated in these~     trials until lack of patient benefit as assessed by investigator, or commercial availability~     and reimbursement.~   "
61690|NCT02759406|"~     This is a six (6) month, randomized, un-blinded, study to assess the safety and performance~     of the Palmaz Mach-5 Grooved Coronary Stent System vs. the Palmaz Bare Metal Coronary Stent~     System.~   "
61691|NCT02759393|"~     The purpose of this study is to investigate whether dexlansoprazole can be as effective as~     double dose PPI to achieve SSR in high BMI cases with reflux esophagitis in Los Angeles~     grades A & B.~   "
61692|NCT02759380|"~     The purpose of this study is to evaluate if a diet with a high content of phytoestrogens can~     slow down the prostate tumor proliferation. Phytoestrogens are found in food items such as~     soy, rye, and seeds.~      Two hundred thirty men with prostate cancer will be included in the study and followed until~     surgery (at least 6 weeks). Half of the study participants will receive general information~     about healthy food choices and a package of foods with high content of phytoestrogens to add~     to their food. The other half will get the same information but not receive the food-package.~   "
61693|NCT02759367|"~     This study evaluates the safety of increasing dietary potassium intake in a hypertensive~     population that may be at risk for hyperkalemia.~   "
61694|NCT02759354|"~     To describe long-term persistence of Hepatitis B and pertussis antibody responses in healthy~     4- to 5 Year old children previously vaccinated with VAXELIS or INFANRIX hexa~   "
61861|NCT02757183|"~     The INTELLIH (brand name of the mobile health application) Diabetes Study is to understand~     the usage of a mobile health application, IntelliH, and connected wireless devices such as~     glucometer by the diabetic patients and ascertain if there are any improvements in short-term~     health outcomes.~   "
61695|NCT02759341|"~     The Tako-Tsubo Cardiomyopathy (TTC) and the Cardiac Syndrome X (CSX) are respectively acute~     and chronic heart diseases, which mimic myocardial infarction and stable angina pectoris~     without alterations of large coronary vessels. The causes and the most appropriate and best~     treatment for these diseases have not been yet clarified, but there are indications, that~     mental and psychosocial aspects may also contribute to these two diseases. So far, there is~     no study, which has comprehensively evaluated the interactions between mind and heart in~     these two conditions.~      The purpose of this study is to search for possible differences in mental activity, response~     to stressful events and function of specific areas of the brain deeply involved in relation~     between mind and heart.~      45 subjects will be recruited and divided equally into: patients with CSX, patients with TTC~     (at least 6 months ago) and patients with previous acute myocardial infarction (at least 6~     months ago). All participants will undergo a clinical interview and several questionnaires~     that assess various mental functions, the stress response and the quality of life. In~     addition, in a separate visit the participants will undergo a Magnetic Resonance Imaging~     without contrast medium that helps to assess function of specific areas of the brain.~   "
61696|NCT02759328|"~     Commercial interactive game consoles including the Nintendo Wii™ and the Sony Playstation~     Eyetoy™ have been used in stroke rehabilitation with variable success and seemed to be safe,~     feasible and effective treatment options. The more recently released Xbox Kinect™ game~     console has superiorities to the others such as not requiring any special controller and~     having a more sensitive sensor which provides more accurate motion-capturing. However, there~     is limited evidence on clinical utility of the Xbox Kinect™ in stroke rehabilitation.~     Currently it has been designed for physically and mentally healthy people just like previous~     consoles. Therefore, the safety and feasibility of the system should be evaluated in first~     place before using it as an alternative or adjunctive training method in stroke patients. To~     the best of our knowledge, no studies have evaluated the clinical feasibility of the Xbox~     Kinect™ in stroke rehabilitation. The aim of this pilot study was to evaluate the feasibility~     and safety of the Xbox Kinect™ training of upper extremity in subacute stroke rehabilitation.~     The secondary aim was to evaluate its efficacy on upper extremity motor and functional~     recovery.~   "
61697|NCT02759315|"~     The study is a single-center, multiple-arm investigation of co-administration of Uprifosbuvir~     (MK-3682) 450 mg and Ruzasvir (MK-8408) 60 mg in participants with chronic Hepatitis C Virus~     (HCV) Genotype (GT)1, GT2, GT3, GT4, GT5, or GT6. The impact of the study treatment regimen~     on Sustained Virologic Response (SVR)12 (undetectable HCV ribonucleic acid [RNA] 12 weeks~     after ending study treatment) for each HCV Genotype will be evaluated in cirrhotic~     participants and non-cirrhotic participants.~   "
61698|NCT02759302|"~     POMT2 mutation is known to cause Walker Warburg Syndrome and Muscle-Brain-Eye syndrome.~     Recently it has been connected to limb girdle muscular dystrophy (LGMD), a disorder~     characterized by muscle weakness and atrophy of the proximal muscles of the shoulder and~     pelvic girdles. LGMD is classified based on its inheritance pattern and genetic cause into~     more than 31 different types. LGMD with POMT2 mutations is a new phenotype - type 2N. Very~     few patients with the LGMD2N phenotype has been reported. In this study, the investigators~     examine five new cases with the LGMD phenotype. The primary aim is to examine the muscle~     involvement using MRI.~   "
61699|NCT02759289|"~     Investigators will recruit 250 subjects; Group A will consist of 100 prediabetic patients~     with an A1c of 5.7%-6.4%. Group B will consist of 100 patients with uncontrolled T2D defined~     as either a) an A1c of 6.5%-7.9% without diabetes medications or b) an A1c ≥ 8.0% with or~     without diabetes medications. Group C will include 50 participants without T2D or known~     cardiovascular disease to serve as control comparisons.~   "
61700|NCT02759276|"~     Nailfold videocapillaroscopy (NVC), Venous occlusion Plethysmography (VOP) and inflammatory~     biomarkers have been used to study endothelial function in patients with resistant~     hypertension, stages 1 and 2 hypertension and normotensive. This was a cross-sectional study.~   "
61701|NCT02759263|"~     Executive dysfunction can profoundly impact all dimensions of a child's development.~     Impairments in executive function are a central component of the neurodevelopmental phenotype~     associated with CHD, and manifest as behavioral dysregulation and problems with attention,~     working memory, and organization/planning abilities. Identifying effective treatment~     strategies is vital for providing optimal care for these patients. The Cogmed executive~     function intervention, an evidence-based computerized neurocognitive program, improves~     outcomes in several pediatric populations. The investigators propose to conduct a pilot study~     to evaluate its efficacy in reducing morbidities in patients with CHD. This is a single~     center, single blinded 2-arm randomized controlled trial to test the immediate post-treatment~     and 3-month follow-up efficacy of Cogmed intervention versus standard of care in adolescents~     with CHD.~   "
61702|NCT02759250|"~     To characterize the safety profile of ARGX-110 administered as mono- or combination therapy~     to patients with NPC at various stages of its natural history (adjuvant vs. metastatic).~   "
61703|NCT02759237|"~     The Medtronic Transcatheter Aortic Valve Implant System (CoreValve System Family) has been~     demonstrated to be safe and effective for high through extreme risk patients with symptomatic~     severe native aortic stenosis or a stenosed, insufficient, or combined surgical bioprosthetic~     valve failure. Per DCGI systematic post marketing surveillance requirement, the purpose of~     this PMS plan is to provide local post marketing surveillance data regarding the safety of~     Medtronic CoreValve System Family~   "
61704|NCT02759224|"~     An Open-Label, Randomized, Single-dose, 2x2 Crossover Study to Compare the Pharmacokinetics~     of BRI-1501 Tablet and Coadministration of Lafutidine and Irsogladine maleate as Individual~     Tablets in Healthy Adult Volunteers~   "
61705|NCT02759211|"~     There have been no published studies to date on the effects of backwards walking in persons~     with MS. Thus it is important that the investigators explore different methods for treatment~     to help improve balance and gait and prevent injury in persons with MS with gait disturbances~     and balance impairments.The overall goal of this research is to collect pilot data on the~     effectiveness of backwards walking as a therapy for improving spatiotemporal, clinical gait~     and balance assessments in persons with Multiple Sclerosis compared to forward walking.~   "
61706|NCT02759198|"~     The purpose of this study is to evaluate efficacy and safety of YH23537 versus celebrex in~     patients with knee osteoarthritis.~   "
61707|NCT02759185|"~     Posttraumatic stress disorder (PTSD) is a debilitating disorder experienced by a subset of~     individuals following life-threatening trauma, such as sexual and physical assault, natural~     disasters, and military combat. Despite there being a number of treatments for PTSD, there is~     a need to help people who have PTSD and do not benefit from these treatments as many~     individuals continue to experience marked PTSD symptoms following treatment. In response to~     overwhelming demand, several U.S. states have passed laws allowing the medical use of~     cannabis (marijuana) by individuals with PTSD. Unfortunately, there has been very little~     scientific evidence on suitability of cannabis as an alternative therapy for PTSD. The~     purpose of this study is to find out if cannabis can reduce PTSD symptoms in 76 military~     veterans with PTSD. Four different types of smoked cannabis will be evaluated using a~     triple-blind cross-over placebo controlled design. After screening and meeting study~     requirements, participants will be randomly assigned to receive one of four types of cannabis~     that vary based on THC and CBD content. During the study, each participant will smoke two of~     the four types of cannabis, up to 1.8 grams per day, for a 3-week period. Participants can~     smoke their daily 1.8g cannabis at any time, using as much as they need. After each 3-week~     cannabis use period, they will stop smoking marijuana/cannabis for two weeks where no~     cannabis use will be allowed. Study findings will help researchers better understand the~     risks and benefits associated with cannabis use among veterans with PTSD, information that~     can be used to aid in shared decision-making among people with PTSD and their doctors or~     therapists.~   "
61708|NCT02759172|"~     The four year SPIRIT Trial, or Suicide Prevention Intervention for at-Risk Individuals in~     Transition, will recruit 800 pretrial jail detainees at risk for suicide. Each participant~     will be randomly assigned to today's standard care or to Safety Planning Intervention (SPI)~     method and then followed for one year after release. Outcomes include suicide events, suicide~     attempts and ideation, psychiatric symptoms, functioning, treatment utilization,~     problem-solving, belongingness, and cost-effectiveness.~   "
61709|NCT02759159|"~     Alzheimer's disease (AD) is one of the major brain diseases which received more attention in~     recent years. The disconnection syndrome is the main pathophysiological mechanism leading to~     cognitive decline in AD patients. Both animal experiment and clinical observation have~     demonstrated that acupuncture can generate treatment effect on AD patients by moderating the~     neural pathway directly. However, the underlying mechanism remains unclear. By using resting~     state functional magnetic resonance imaging (fMRI) method, as well as acupuncture and~     neurology sciences, investigators will explore the multi-modality data analysis; compare~     brain connectivity and network parameters changes between pre- and post- acupuncture~     treatment; analyze the correlation between fMRI changes and neuropsychology test. The present~     study aims to elucidate the neural mechanism of acupuncture therapy on early AD, provide~     theoretical evidence from the perspective of functional connectivity.~   "
61710|NCT02759146|"~     In order to optimize symptom management, there must be a shift from fixed interventions one~     size fits all to adaptive interventions tailored to individual patients. Our multistaged~     interventions use the sequential multiple assignment randomized trial (SMART) design. This~     design will operationalize the decision rules for switching from one intervention to another~     for individual patients. Our team's work to date with breast and lung cancer patients has~     shown efficacy for two home-based symptom management interventions, reflexology and~     meditative practices, delivered by or with friend or family caregivers. The sustainability of~     use of these two evidence based therapies and improvements in symptom outcomes will be tested~     during weeks 5-8 and at the week 12 follow up of 331 patients based on power analysis,~     against a control group. By sequencing two evidence based interventions, the proposed~     research will impact research and practice by determining how to maximize the benefit of~     symptom management during cancer treatment.~   "
61711|NCT02759133|"~     This is a monocentric, non-inferiority, randomized cohort study with an open 1:1 ratio~     comparing the impact of iodine seed tumor localization (arm B) vs. standard localization~     using a metal guide (arm A) on the quality of the surgical resection margins in parallel~     groups with an interim analysis in patients with breast cancer.~      Randomization will be performed using histologic status stratification: in situ ductal~     /invasive lobular +/- an in situ component / invasive ductal +/- an in situ component.~   "
61712|NCT02759120|"~     The purpose of this study is to compare the effect of standard care, versus standard of care~     plus antimicrobial therapy (co-trimoxazole or doxycycline), on clinical outcomes in patients~     diagnosed with idiopathic pulmonary fibrosis (IPF).~   "
61713|NCT02759107|"~     The main purposes of this study are to determine:~        -  The safety of LY3298176 and any side effects that might be associated with it.~        -  How much LY3298176 gets into the bloodstream and how long it takes the body to get rid~          of it.~        -  How LY3298176 affects the levels of blood sugar.~      This study includes 3 parts (A, B and C). Part A involves a single dose of LY3298176 taken as~     a subcutaneous (SC) injection just under the skin and will be approximately 10 weeks in~     duration, including screening. Parts B and C involve 4 doses of LY3298176 taken once weekly~     (over 4 weeks) as a SC injection just under the skin and is approximately 12-14 weeks in~     duration, including screening. Each participant will enroll in only one part.~      This study is for research purposes only, and is not intended to treat any medical condition.~   "
61714|NCT02759094|"~     Prospective, open-label, multi-centre, single arm treatment only trial to evaluate the safety~     and effectiveness of RefluxStop for the treatment of GERD.~      The used medical device RefluxStop is an implantable single use sterile device to ensure~     maintenance of gastro oesophageal junction (GEJ) in an intra-abdominal position to reduce or~     eliminate GERD.~   "
61715|NCT02759081|"~     This prospective, randomize, controlled trial will compared cap-assisted water exchange with~     water exchange in patients undergoing sedated colonoscopy. Investigators test the hypothesis~     that that cap-assisted water exchange is more efficient and causes a shorter insertion time.~   "
61716|NCT02759068|"~     Preferred music improves cognitive function in patients with disorders of consciousness~     (DOC). However, it is still unknown whether it is a general effect of music (because of its~     acoustic features) or an autobiographical effect (because of its emotional and meaningful~     contents).~      The aim of the present study was to investigate the effect of sensory modality (auditory~     versus olfactory) and preference (preferred versus neutral) of the testing context on the~     performance of four items from the coma recovery scale-revised~   "
61717|NCT02759055|"~     Nearly one in three adults has prediabetes, a condition that substantially increases the risk~     of heart attacks and stroke. The increased cardiovascular risk associated with prediabetes~     can be effectively managed by lifestyle changes or medication therapy, but recent data shows~     few prediabetes patients are treated effectively. In this project, we will adapt, implement,~     and evaluate a proven electronic health record-linked, web-based clinical decision support~     system to identify patients with prediabetes and provide prioritized treatment~     recommendations to patients and providers in a rural health system. The results of the~     project will provide a template for implementation of more efficient and effective rural~     healthcare and have the potential to substantially and improve cardiovascular quality of care~     and clinical outcomes of millions of rural Americans with prediabetes.~   "
61718|NCT02759042|"~     The primary objective is to provide continued access to PRO 140 to a subject who has~     completed participation in PRO140_CD02.~   "
61719|NCT02759029|"~     Helicobacter pylori eradication (H. pylori) rates with clarithromycin-based triple therapy~     are declining, and an alternative strategy is needed urgently. The investigators sought to~     compare the efficacy of pretreatment antimicrobial susceptibility-guided vs.~     clarithromycin-based triple therapy vs. concomitant therapy for H. pylori eradication in a~     region with high rates of multiple drug resistance.~   "
61720|NCT02759016|"~     Intravenous BI 836826 in combination with ibrutinib in relapsed/refractory Chronic~     Lymphocytic Leukemia (CLL) patients who have been pre-treated with at least one prior line of~     systemic therapy, and who are eligible for treatment with ibrutinib. Objectives of the trial~     are to determine the recommended Phase 2 dose of BI 836826, to investigate the number of~     patients with a complete response and to document the safety and tolerability of BI 836826~     when given in combination with ibrutinib~   "
61721|NCT02759003|"~     In patients with amyotrophic lateral sclerosis (ALS), non-invasive mechanical ventilation~     (NIV) is usually initiated in an in-hospital regime. The investigators evaluated if NIV~     initiated in an outpatient setting can be as effective as regards patients' adherence. The~     investigators also evaluated factors predicting NIV adherence and disease progression.~   "
61722|NCT02758990|"~     The purpose of this study is to study interactions between genes, lifestyle environmental~     factors like foods, nutritional supplements and non-invasive medical devices and health~     factors that can be measured without specialized medical equipment in order to develop~     lifestyle recommendations tailored to individual genetics for a host of common chronic health~     conditions.~   "
61723|NCT02758977|"~     Surgical resection has offered the best option for prolonged survival in patients with~     colorectal liver metastases. Limiting factor for major liver resections is the size of the~     future liver remnant (FLR). In case of normal liver function, 30% of the total liver volume~     is considered to be sufficient to maintain adequate liver function after resection. In an~     attempt to further increase resectability criteria for patients with too small FLR surgical~     and interventional maneuvers such as portal vein embolization and portal vein ligation in~     two-stage hepatectomies have been implemented, but they need an interval of 4-8 weeks to~     achieve sufficient hypertrophy. In order to obtain adequate but rapid parenchymal hypertrophy~     a new surgical two-step technique, ALPPS, was introduced for oncological patients requiring~     extended hepatic resection with limited functional reserve. Both procedures can be performed~     with acceptable morbidity and mortality.~      The investigators conclude that it is time to perform a randomized study comparing the two~     surgical approaches in regard to oncological outcome.~   "
61724|NCT02758964|"~     EARTH-TAVR is a diagnostic multicenter study to evaluate the occurrence and extent of~     cerebral embolization (total new lesion volume) in patients before TAVR versus 3 months after~     TAVR.~   "
61725|NCT02758951|"~     Patients with potentially resectable peritoneal metastases arising from colorectal cancer are~     randomised to (1) cytoreductive surgery with HIPEC and perioperative systemic therapy versus~     (2) cytoreductive surgery with HIPEC without perioperative systemic therapy.~   "
61726|NCT02758938|"~     The goal of this study is to test the usability of updated biofeedback game software~     developed to help train the muscles involved in lower urinary tract dysfunction (LUTD)~     through electromyography (EMG) controlled video games.~      A Windows-DOS based biofeedback game system is currently used at the investigator's~     institution to help treat LUTD in pediatric patients. This system, however, is outdated and~     needs to be replaced with updated hardware and software. A new updated system was recently~     created by University of Wisconsin-Madison (UW) Biomedical Engineering students. This system~     utilizes a FDA approved EMG device (SRS Medical Aware™ EMG Dual Muscle Monitor) paired with~     biofeedback game software that was developed by the students. The investigators wish to test~     the usability of the new software to identify areas that need improvement to make the~     software more user-friendly.~      This study will evaluate the end users' (i.e., physician, biofeedback nurses, patients)~     perception of the updated software. In determining usability, we hope to 1) decrease risk of~     end user error; 2) make the software intuitive (easier to use); 3) decrease reliance on the~     user manual; 4) decrease need for training; and 5) increase understanding of software~     operation. This will be an ongoing study in which we continuously monitor the usability of~     the software as it is updated based on end-user feedback. The investigators plan to do all~     usability testing under the same IRB protocol. If further testing involves items not~     discussed here, a new change will be made to the IRB application.~   "
61727|NCT02758925|"~     Forty percent of patients with diffuse large B cell lymphoma (DLBCL) have primary refractory~     or relapsed disease (R/R). For these fit patients, standard treatment in second line therapy~     is high dose therapy with autologous stem cell transplantation (ASCT). In 48% of DLBCL no~     ASCT is possible due to progressive disease. For these patients or ineligible to~     transplantation patients, salvage therapy is often rituximab-gemcitabine-oxaliplatine regimen~     with an overall response rate (ORR) about 50%.~      Bendamustine in combination with rituximab, used as a single agent in the setting of R/R~     DLBCL patients, have shown an ORR of 62.7% and 45.8% with a good safety profile.~      Bendamustine and cytarabine (BAC) showed high synergy in inducing cell death in mantle cell~     lymphoma and DLBCL cell lines. In a recent phase II study, the combination of cytarabine with~     Rituximab and Bendamustine (R-BAC) in patients with mantle cell lymphoma who were previously~     untreated, refractory or relapsed was evaluated.~      The efficacy and safety of the R-BAC association will be evaluated in this phase II trial~     enrolling 78 patients with relapsed or refractory DLBCL.~   "
61729|NCT02758899|"~     The purpose of this study is to determine the relevant significance of diabetes on cervical~     disc degeneration, and correlate diabetic control (HgbA1C) with disc glycosylation profile in~     patients undergoing anterior cervical discectomy and fusion for cervical spondylosis.~     Additionally, to compare the level of degenerative cervical disc glycosylation in patients~     with and without diabetes.~      Hypothesis: Patients with diabetes and degenerative cervical disc disease have higher levels~     of disc tissue glycosylation, and higher levels of glycosylation are correlated with poor~     outcomes.~   "
61730|NCT02758886|"~     The purpose of this study is to determine whether an animal visitation programs on college~     campuses are effective in the treatment of college student stress reduction during~     preparation for final examinations.~   "
61731|NCT02758873|"~     One in every 11 children in the United Kingdom (UK) has asthma. Children with asthma cough,~     wheeze and have difficulty breathing. The symptoms which children experience can mean they~     miss school and makes it difficult for children to take part in playground games and sports.~     Some have to be admitted to hospital. In fact, in the UK a child is admitted to hospital~     every 18 minutes because of their asthma.~      Effective medicines are available, but a child's response to these medicines is currently~     unpredictable. This project focuses on an asthma controller medicine called salmeterol.~     According to reports, tens of thousands of children may be taking this medicine in the UK,~     but evidence suggests it might not work for around one in seven of them. The study team are~     investigating whether a new approach to treatment, where prescribing is personalised~     according to a child's genetic make-up, improves the child's quality of life and provides~     better control of their asthma. Treatment that is tailored in this way to a person's genetic~     features is often called 'personalised medicine'.~      At the moment, doctors commonly prescribe salmeterol to relieve asthma symptoms if children~     do not benefit enough from other medicines. But evidence suggests salmeterol may not work~     properly in children with a certain genetic makeup.~      The study team are investigating whether it helps to take children and young people's genetic~     makeup into account when deciding whether to give them salmeterol or an alternative medicine~     called montelukast. A simple and inexpensive saliva test can provide the information needed~     to guide decision making.~   "
61732|NCT02758860|"~     The Diverticular Inflammation and Complication Assessment (DICA) is an endoscopic~     classification for diverticulosis and diverticular disease of the colon.~      The aim of the study is to show that DICA classification is a valid parameter to predict the~     risk of acute diverticulitis occurrence/recurrence and the need of surgery in patients~     suffering from diverticulosis/diverticular disease of the colon.~   "
61733|NCT02758847|"~     The use of drug coated balloon (DCB) in patients with critical limb ischemia (CLI) and tissue~     loss has recently raised some concerns after the IN.PACT deep trial using paclitaxel coated~     balloon angioplasty in the tibial arteries was terminated. The investigators objective is to~     establish the safety and efficacy of drug coated balloon (DCB) for femoropopliteal occlusive~     disease in patients with critical limb ischemia (CLI) and tissue loss.~      The investigators objective is to establish the safety and efficacy of drug coated balloon~     (DCB) for femoropopliteal occlusive disease in patients with critical limb ischemia (CLI) and~     tissue loss.~   "
61734|NCT02758834|"~     The purpose of this study is to determine plasma phytosterols half-lives in preterm infants~     who received intravenous soy oil-based lipid emulsions.~   "
61735|NCT02758821|"~     PRIMARY OBJECTIVE To assess the impact of C-reactive protein (CRP) Point-of-care (POC)~     testing on health care worker prescribing behaviour in patients presenting to primary~     healthcare centres with an acute fever or recent history of fever.~      SECONDARY OBJECTIVES To assess the impact of CRP testing on clinical outcomes within the 14~     days of follow-up.~      To assess the correlation between CRP results and clinical outcomes on the day 5 of the~     enrolment.~      To estimate the impact of CRP testing on antibiotic consumption after first consultation.~      To explore the attitudes of health centre staff towards the POC CRP test. To identify the~     prevalence of key pathogens in febrile patients in these settings.~      To validate the ability of CRP to discriminate between viral and bacterial pathogens in a~     subset of patients with a microbiologically confirmed diagnosis.~   "
61736|NCT02758808|"~     The Pulmonary Fibrosis Foundation Patient Registry will collect data on at least 2,000~     patients with interstitial lung disease (ILD) at approximately 40 clinical sites in the US.~     The Registry is targeting enrollment of approximately 60% of the 2,000 ILD participants to~     have idiopathic pulmonary fibrosis (IPF). The aim of the Registry is to create a cohort of~     well-characterized patients with interstitial lung disease (ILD) for participation in~     retrospective and prospective research~   "
61737|NCT02758795|"~     The aim is to evaluate the effect of ingestion of a modified bovine milk protein on~     circulating markers of inflammation in healthy men and women aged 50-70y.The focus is healthy~     ageing, i.e. delaying the deterioration in health status in older adults. Loss of lean tissue~     mass, termed sarcopenia is a consequence of aging per se, modified by nutrition and lifestyle~     behaviour. Advancing the prospect of 'successful aging' a 6-month period of protein-based~     nutritional support has shown preservation/accrual of lean tissue. Chronic low-grade~     inflammation is common in ageing and is a compounding factor leading to 'anabolic blunting',~     i.e. a reduced sensitivity of lean tissue to enhance the synthesis of lean tissue mass in~     response to protein feeding. Using a simulated human gastrointestinal digestion model we have~     recently shown proteins to have an anti-inflammatory bioactivity in vitro. This study~     investigates whether the anti-inflammatory response is retained, post-digestion in vivo.~   "
61738|NCT02758782|"~     To evaluate the impact of treatment with a non-steroidal anti-inflammatory drug (NSAID) -~     Celecoxib - when added to anti-tumour necrosis factor (TNF) therapy - Golimumab - as compared~     to anti-TNF therapy (Golimumab) alone on progression of structural damage in the spine over~     two years in patients with ankylosing spondylitis (AS).~   "
61739|NCT02758769|"~     Examine the effectiveness and safety of the abatacept administration in biologic-naïve~     rheumatoid arthritis patients who have moderate disease activity despite treatments with~     conventional synthetic disease modified anti-rheumatic drugs.~   "
61930|NCT02756286|"~     The purpose of this study is to refine a new assessment tool for Attention~     Deficit/Hyperactivity Disorder (ADHD) and then to test its validity (i.e. ability to~     discriminate between individuals with ADHD and healthy controls.~   "
61740|NCT02758756|"~     The proposed study will assess whether either massage or an Integrative Medicine practice~     called Reiki can alleviate fatigue in subjects receiving hormonal treatments. Reiki is~     classified by the National Center for Complementary and Integrative Health as a~     biofield/touch therapy, and Reiki practitioners believe that their gentle therapy promotes~     healing and well-being by unblocking and balancing energy flow and re-establishing~     homeostasis within the human energy field. The study is a three-arm randomized clinical trial~     in 99 breast and prostate cancer patients who are undergoing hormonal therapy (i.e., androgen~     deprivation therapy (ADT) for males or an aromatase inhibitor (AI) for females) and currently~     experiencing fatigue. Subjects will be studied during ten weeks of hormonal therapy with two~     weeks of baseline assessments followed by a four-week intervention, and a four-week~     post-intervention period. Arm 1: Subjects will receive two Swedish-style massages. Arm 2:~     Lower-dose Reiki intervention - Subjects will receive two Reiki treatments. Arm 3:~     Higher-dose Reiki intervention - Subjects will receive four Reiki treatments.~   "
61741|NCT02758743|"~     The purpose of this study is to validate the novel hypothesis that regular use of Acetium~     Lozenge is promising novel method to assist in smoking cessation.~      The aim of this confirmatory study is to affirm the promising results obtained in a previous~     smoking intervention trial with Acetium lozenge. If successful, the trial gives adequate~     power to confirm, that the Acetium lozenge represents a breakthrough in the development of~     smoking intervention methods.~   "
61742|NCT02758730|"~     This is a randomized, placebo-controlled, parallel group, patient-blind, single-center phase~     I clinical trial of repeated once every 4 weeks administration by subcutaneous injection of~     AFFITOPE® PD01A, adsorbed to aluminium oxide in 30 patients with PD-GBA over a treatment~     period of 8 weeks. Patients will be randomized in a 2:1 ratio to two different treatment~     groups: A) 75 µg AFFITOPE® PD01A, adsorbed to aluminium oxide and B) placebo (= 1 mg~     aluminium oxide).~      Over a study duration of 52 weeks, each patient will receive 3 injections of AFFITOPE® PD01A~     or placebo during the participation in the clinical trial. Patients will either receive 75 µg~     AFFITOPE® PD01A adsorbed to 1 mg aluminium oxide or placebo (=1mg aluminium oxide). The~     treatment group consists of 20 PDGBA patients, the placebo group of 10 PDGBA patients. Male~     and female patients aged 40 to 80 years can participate in the trial.~      AFF010 is part of the project MULTISYN funded by the European Commission~     (FP7-HEALTH-2013-INNOVATION-1 project; N° HEALTH-F4-2013-602646).~   "
61743|NCT02758717|"~     This phase II trial studies how well nivolumab and brentuximab vedotin work in treating older~     patients with untreated Hodgkin lymphoma. Monoclonal antibodies, such as nivolumab, may block~     cancer growth in different ways by targeting certain cells. Biological therapies, such as~     brentuximab vedotin, use substances made from living organisms that may stimulate or suppress~     the immune system in different ways and stop cancer cells from growing. Nivolumab and~     brentuximab vedotin may work better in treating older patients with untreated Hodgkin~     lymphoma.~   "
61744|NCT02758704|"~     This study will be a randomized controlled trial designed to analyse the impact of stress on~     the success rate of a simulated neonatal endotracheal intubation. To do this, pediatric~     residents will be enrolled and randomized to either a high-stress (HS) or low-stress (LS)~     environment where they will be asked to perform a standard neonatal intubation procedure.~     Subjects will then cross-over to the second scenario within a short window (1-2 weeks).~     Outcome measures include: endotracheal intubation success rate and assessment of the~     procedure performance by video-review using a standardized checklist rated by two independent~     reviewers. Stress level will be measured using salivary cortisol, heart rate and a~     standardized anxiety questionnaire.~   "
61745|NCT02758691|"~     Recent research has suggested insulin may be involved in how human's form and recall~     memories. This study is designed to look at how nasal insulin is used in the brain.~     Specifically, how insulin alters the various connections within brain regions that occur~     while adults perform simple attention and memory tasks. This study is divided into two parts:~     blood draw procedure and fMRI (functional Magnetic Resonance Imaging) procedure. The blood~     draw procedure is designed to look at the effects of intranasal insulin using a Precision~     Olfactory Delivery (POD) device on the blood levels of glucose and insulin. Those asked to~     participate will receiving a low-dose saline solution and low-dose of insulin through a nasal~     spray followed by a blood draw session to measure your blood glucose and insulin levels over~     a 90 minute period.~      Participation in the fMRI (functional Magnetic Resonance Imaging) procedure will involve~     receiving a low-dose of insulin or a saline solution through a nasal spray using a Precision~     Olfactory Delivery (POD) device and brain scan using Magnetic Resonance Imaging (MRI). During~     the scan, participants will complete a series of memory tasks reflected on a computer screen.~     The trial will be randomized and double-blinded.~   "
61746|NCT02758678|"~     Purpose:~      Selectins are vascular cell adhesion molecules involved in adhesive interactions of~     leukocytes and platelets and endothelium within the blood circulation.~      Plasma soluble P selectin (sP-selectin), is a one of member of selectin family, an adhesion~     molecule and component of the membrane of the platelet alpha granulate has been proposed as a~     one marker of platelet activation. In this study we evaluate of expression of P selectin on~     platelets of blood between serum samples from lung cancer and healthy individuals.~   "
61747|NCT02758665|"~     A prospective, open-label, multicentre phase-II trial of ibrutinib plus venetoclax plus~     obinutuzumab in physically fit (CIRS ≤ 6 & normal creatinine clearance) and unfit (CIRS > 6 &~     creatinine clearance ≥ 50 ml/min) patients with previously untreated chronic lymphocytic~     leukemia (CLL) with TP53 deletion (17p-) and/or mutation~   "
61781|NCT02758223|"~     PACT is a non-randomized multicentre phase I/II study to evaluate the feasibility and safety~     of the prophylactic administration of donor derived TCM. Patients with Acute Myeloid Leukemia~     (AML) or Myelodysplastic Syndrome (MDS) who are planned to undergo a HLA -matched (9/10 or~     10/10) allogeneic hematopoietic stem cell transplantation and who are either 50+ years old or~     have a high comorbidity score are included according to criteria as described below. TCM will~     be applied in escalating doses to a maximum of 30 patients who have received T cell depleted~     Human leukocyte antigen (HLA)-matched alloHSCT grafts and qualify for TCM transfer.~   "
61782|NCT02758210|"~     The purpose of this study is to evaluate the effects that electromagnetic field exposure from~     using a tablet and smart phone have on a leadless pacemaker (MICRA device).~   "
61748|NCT02758652|"~     Epithelial ovarian cancer is the most lethal gynecological malignancy in developed countries~     and the fifth most common cause of cancer-related death in women. Poor prognosis is due to~     challenges in early diagnosis and development of inevitable resistance to chemotherapy in~     majority of patients despite of good initial treatment response. The purpose of this~     prospective study is to analyze variation in microRNA expression in prediction of primary~     treatment response and the role of microRNAs in development of chemoresistance in epithelial~     ovarian cancer.~      • Objectives: To screen microRNAs from prospectively collected plasma, urine and tumor~     samples from patients diagnosed with epithelial ovarian cancer. Samples are analyzed for~     microRNA expression and differential expression is correlated with primary treatment~     response, progression-free survival and overall survival.~      • Methods: Plasma, urine and tumor samples are collected at primary surgery (open surgery or~     diagnostic laparoscopy) or interval debulking surgery, at 1st, 3rd and 6th neoadjuvant or~     adjuvant chemotherapy and at progression for high-throughput screening of microRNA expression~     by array technology.~   "
61749|NCT02758639|"~     Parental cancer can cause substantial behavioral and emotional distress in both parent and~     child. Parents struggle with talking with their child about their cancer and supporting the~     child during treatment. Over 73% of patients with children desire information and services to~     support their children yet only 9% of these families report receiving this support. The~     purpose of this study is to evaluate the Wonders & Worries psychosocial intervention designed~     for children ages 5-14 who have a parent diagnosed with early stage cancer.This study is a~     randomized controlled clinical trial (RCT) evaluating the Wonders & Worries group and~     individual intervention for school age children (5 -14 years old) who have a parent with~     cancer. Families will be enrolled at the time of initial parent consultation, given informed~     consent, and then randomized either to the intervention group of 30 families or the~     wait-listed control group of 30 families. Both groups will be given a series of standardized~     validated assessment instruments including the Revised Children's Manifest Anxiety Scale~     (RCMAS), the Child Behavior Checklist (CBCL), and the Family Communication Scale FACES IV at~     baseline, post intervention, and 8 week follow up. Upon completion of the follow up measures,~     families in the wait-listed control group will be enrolled into the intervention. Parent exit~     interviews for both groups will be used to measure parent-reported child outcomes and program~     utility.~   "
61750|NCT02758626|"~     This is a phase 2, crossover study of Ataluren for the treatment of nonsense mutation Dravet~     syndrome or cyclin-dependent kinase-like 5 (CDKL5) deficiency, resulting in drug-resistant~     epilepsy. Patients will receive 12 weeks of ataluren or placebo during each treatment period.~     Treatment Period 1 will be followed by a 4-week Washout Period. Based on ataluren PK and~     pharmacodynamic data, the 4-week washout period is deemed an appropriate length of time to~     eliminate any ataluren drug effects. Following the Washout Period, patients will crossover to~     receive the opposite treatment during Treatment Period 2 as follows: Patients receiving~     ataluren during Treatment Period 1 will receive placebo during Treatment Period 2. Patients~     receiving placebo during Treatment Period 1 will receive ataluren during Treatment Period 2.~   "
61751|NCT02758613|"~     The main purpose of this study is to investigate the safety and tolerability of the study~     drug known as baricitinib in healthy Chinese participants. The study will measure how the~     body absorbs, breaks down and gets rid of baricitinib. The study will last about 20 days, not~     including screening. This study is for research purposes only, and is not intended to treat~     any medical condition.~   "
61752|NCT02758600|"~     Coronary arterial bypass graft surgery (CABG) is proven safe with improved survival and~     greater quality of life in patients with coronary arterial disease. Evidences on the~     cardiovascular and gas-exchanges responses during and right after early exercise-based~     rehabilitation of this patients are limited. Objective: The investigators aim to analyse~     breath-by-breath cardiopulmonary and metabolic responses during six-minute walk test (6MWT)~     and shuttle walk test (SWT) in patients with or without left ventricular dysfunction (LVD)~     after CABG. In addition, the investigators will investigate oxygen consumption and~     cardiopulmonary responses during the early exercise-based rehabilitation in the first days~     after surgery. Methods: According to the left ventricular ejection fraction (LVEF), subjects~     will be allocated into two groups: with LVD (LVEF < 45%) and without LVD (LVEF > 45%).~     Patients will be submitted to the 6MWT and SWT linked to portable spirometric-telemetric~     device before and 6 days after CABG. During the first days after surgery, patients will be~     evaluated about pulmonary function and respiratory strenght at rest and oxygen consumption~     during the portable cycle ergometer protocol. Clinical outcomes as time to hospital~     discharge, pulmonary complications and occurence of arrythmias will be assessed during~     inpatient time until hospital discharge. Incidence of mortality, hospital readmission and~     angina recurrence will be evaluated in a one-year follow up.~   "
61753|NCT02758587|"~     This study will explore whether defactinib (a FAK inhibitor) can be safely and tolerably~     combined with pembrolizumab (a PD-1 inhibitor) and will look for early indications of~     improved anticancer immunotherapy. It will focus on three key cancers, all in clear need of~     improved therapies - NSCLC, pancreatic cancer and mesothelioma.~   "
61754|NCT02758574|"~     The study will compare standard catheter directed thrombolysis to ultrasound accelerated~     thrombolysis for the treatment of acute submassive pulmonary embolism (PE). The study~     population will include patients eligible for catheter directed thrombolysis (CDT) for~     submassive PE. Subjects will be randomized to, either, standard catheter-directed~     thrombolysis or ultrasound-accelerated thrombolysis (USAT).~   "
61755|NCT02758561|"~     This pilot study will assess the feasibility and acceptability of an educational workshop on~     pelvic floor disorders and its potential impact on decisional conflict.~   "
61756|NCT02758548|"~     The purpose of this study is to determine the accuracy of the Novel point of care test (POCT)~     total IgE assay in atopic patients.~      120 patients with atopic conditions and approximately 40 healthy subjects will be enrolled.~     Fingerstick capillary blood samples will be collected and tested in the POCT device. Venous~     samples will be collected and sent to a reference laboratory for measurement of serum total~     IgE using the reference immunoassay method.~   "
61783|NCT02758197|"~     This randomized controlled trial will evaluate the effectiveness of an interdisciplinary~     treatment approach combining medical management with an online Mindfulness-Based Stress~     Reduction (MBSR) program in reducing disability and improving quality of life among cancer~     survivors living with moderate to severe chronic neuropathic pain.~   "
61757|NCT02758535|"~     Percutaneous image-guided parenchymal renal biopsy has been used to detect the different~     pathologies of renal parenchyma, to define the degree of reversible changes, and to define~     when the medical treatment fails. Percutaneous core needle renal biopsy has been reported to~     have a higher diagnostic yield compared to fine needle aspiration. Percutaneous core needle~     renal biopsy is usually based on tissue sampling under guidance of either sonography or~     computed tomography. Renal parenchymal biopsy can be done either with a coaxial or noncoaxial~     technique. In coaxial technique, the introducing needle is placed in the renal parenchyma;~     then, multiple tissue sampling can be performed throughout the same tract. Alternatively, in~     noncoaxial technique, biopsy needle is inserted repeatedly for each tissue sampling. Although~     there are some reports regarding the comparison of coaxial and noncoaxial methods of renal~     mass biopsy, comparison of the two methods in renal parenchymal biopsy has not yet been~     described in the literature. In this prospective study, the investigators sought to compare~     the procedural time and the complication rate of coaxial technique with those of noncoaxial~     technique in percutaneous renal parenchymal biopsy.~   "
61758|NCT02758522|"~     The objective of this study is to compare the therapeutic efficacy of three regimens of~     insulin NPH/fast for optimal glycemic control in non-critical hospitalized patients.~   "
61759|NCT02758509|"~     Hepatitis C virus (HCV) chronic infection affects 200 million people worldwide. HCV antiviral~     treatment has evolved rapidly since 2011. The use of pegylated interferon (PEG-INF) with~     ribavirin (RBV) has supposed high serious adverse events (SAEs) and low efficacy, especially~     in patients with cirrhosis. The introduction of 1st generation protease inhibitors (PIs) in~     genotype-1 (GT1) HCV, such as boceprevir (BOC) and telaprevir (TVR), improved the efficacy~     but increased the SAEs. Currently, interferon-free direct-acting antivirals (IF-DAAs) achieve~     great effectiveness with minimum SAEs. However, studies evaluating efficacy and safety of~     DAAs in cirrhotic patients are limited in real clinical practice. The aim of our study is to~     evaluate in HCV-cirrhotic patients the efficacy and safety of 3 treatment strategies~     (PEG-IFN/RBV, PEG-IFN/RBV/PIs, and IF-DAAs) in routine practice according to European~     guidelines from 2010 to 2015. The secondary aim is to evaluate the impact of sustained~     virological response on gastroesophageal varices (GOV).~   "
61760|NCT02758496|"~     The purpose of this study is to evaluate the safety and efficacy of Magnetic EEG/ECG-Guided~     Resonance Therapy (MeRT) on subjects with Autism Spectrum Disorder (ASD).~   "
61761|NCT02758483|"~     BACKGROUND: The treatment with continuous glucose monitoring system (CGMS) offers improved~     glycemic control for patients with type 1 diabetes. However, patients with type 1 diabetes~     usually intake foods with sugar, even without hypoglycemic episodes, and the use of advanced~     carbohydrate counting method may increase the calories and carbohydrate intake.~      OBJECTIVE: To evaluate and compare the influence of sucrose-free diet or sucrose-added diet~     on glucose variability in patients with type 1 diabetes.~      METHODS: The study was a simple-blind, two-way crossover design in which patients with type 1~     diabetes will receive a control diet (a diet with a little quantity of sugars) or test diet~     (with foods containing moderate quantity of sucrose in composition) during two-days each.~     During the intervention, all foods and drinks intake will have to be documented to allow~     quantitative estimation of dietary intake, to verify adherence to the diets. After one-week,~     each patient will return for download CGMS.~      PURPOSE: The research proposal adds knowledge about the glucose variability in patients with~     type 1 diabetes who use foods with sugar in theirs habitual dietary intake.~   "
61762|NCT02758470|"~     The objective of this research is to assess the effects of acetazolamide and methazolamide on~     respiratory and limb muscle fatigue development. A fatiguing protocol will be conducted for~     the respiratory and plantar flexor muscles and the difference in pressure/torque produced by~     supramaximal nerve stimulation used to assess muscle fatigue between conditions.~   "
61763|NCT02758457|"~     The objective of this study was to compare the 5-year survival and clinical behavior of~     single posterior ceramic crowns made with pressable ceramic on zirconia or on a metal~     framework. If failures occurred, the further aim of the study was to delineate the factors~     contributing to the failure. The null hypothesis stated that the survival of zirconia-based~     restorations would be no worse that those made with metal-based material.~   "
61764|NCT02758444|"~     The overall objective is to determine the impact of EED on total daily zinc absorption of~     young Bangladeshi children (18-24 months of age) in an austere setting with high rates of~     diarrhea, stunting, and micro-nutrient deficiencies..~   "
61765|NCT02758431|"~     This study plans to learn more about heart and vascular aging in men. In some men as they get~     older, testosterone levels fall below the normal range for young men. Also, as men get older~     cardiovascular health worsens. This can lead to high blood pressure and heart disease. In~     this study we want to find out what causes cardiovascular health to worsen in older men. Also~     we want to find out what happens when testosterone levels are lowered for a short time.~     Specifically, we want to see if the reduction in cardiovascular health in older men with low~     testosterone levels is because of damage to mitochondria. Mitochondria are the main power~     supply of the cells in our body. The results from this study will help to understand why~     cardiovascular health declines in older men with low testosterone levels compared to younger~     men and older men who have higher testosterone levels. Knowing this information will help to~     develop therapies to prevent heart disease in men.~   "
61766|NCT02758418|"~     The purpose of this study is to determine the efficacy and effectiveness of a self-help~     treatment for adjustment disorders administered through a computerized program applied over~     the Internet. This treatment modality will be compared with a waiting list control group.~      It is expected that, on the one side, the intervention group will improve significantly~     compared to the waiting list control group. On the other side, it is expected the~     self-applied online treatment program to be well accepted and valued by the patient.~   "
61784|NCT02758184|"~     The Purpose of this study is to identify added value of Rotational thrombo-elastometry~     (ROTEM) intra-operative coagulation surveillance on reducing blood product use during major~     reconstructive spine surgery.~   "
61785|NCT02758171|"~     The primary objective of this trial is to investigate the bioequivalence of one fixed dose~     combination tablet of empagliflozin/linagliptin (Test, T) compared with the free combination~     of one empagliflozin tablet and one linagliptin tablet (Reference, R) administered as single~     dose under fasted conditions.~   "
61767|NCT02758405|"~     Brief Summary:~      Until recently, at Mount Sinai Hospital, epidural analgesia for labor pain was delivered with~     a pump that could only provide continuous infusion of the freezing medication in combination~     of pushes of medication activated by the patient, a technique called patient controlled~     epidural analgesia (PCEA). In the last decade or so, the literature has suggested that this~     continuous infusion of medication is not as effective as previously thought, and suggested~     that instead of continuous infusion, intermittent programmed pushes should be used. The~     investigators now have devices that are able to do that. Programmed intermittent epidural~     bolus (PIEB) is a new technological advance based on the concept that boluses of freezing~     medication in the epidural space are superior to continuous epidural infusion (CEI). The~     investigators are currently using pumps set up with PIEB, in addition to what the patient can~     deliver herself (PCEA). Studies have shown that delivering analgesia in this manner prolong~     the duration of analgesia, reduce motor block, lower the incidence of breakthrough pain,~     improve maternal satisfaction and decrease local anesthetic consumption. The investigators~     have recently concluded a study at MSH using PIEB where they observed excellent results.~     However, some patients exhibited higher than necessary sensory blocks. The investigators~     believe that the technique can be optimized by using the same dose of the freezing~     medication, but using a smaller volume of local anesthetic at a higher concentration. This~     optimization may also further reduce the amount of medication used by each patient.~      The hypothesis of this study is that there is an optimal interval time between PIEB boluses~     of 30 to 60 minutes at a fixed volume of 5 ml of bupivacaine 0.125% with fentanyl 2mcg/ml~     that will provide women the necessary drug requirements, thus avoiding breakthrough pain and~     need for PCEA or physician intervention.~   "
61768|NCT02758392|"~     The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and~     immunogenicity of JNJ-61178104 following a single ascending Intravenous (IV) dose~     administration and a single Subcutaneous (SC) dose administration in healthy participants.~   "
61769|NCT02758379|"~     The objective of this clinical trial is to study the early safety and feasibility of the~     Shockwave Coronary Lithoplasty System. To demonstrate that the Shockwave device can safely~     and effectively deliver localized shockwave energy for balloon dilatation of calcified,~     stenotic, de novo coronary lesions.~   "
61770|NCT02758366|"~     The standard therapy of glioblastoma (GBM) consists of gross total resection followed by~     focal irradiation to the tumor bed with concomitant and adjuvant temozolomide (TMZ). The~     association of valproic acid and TMZ during radiotherapy improves survival of GBM.~     Preclinical studies suggested that doxorubicin had a strong antineoplastic activity against~     human gliomas. Moreover, some studies showed that the continuous infusion of anthracyclines~     in patients with solid tumor ensured a better safety profile compared with bolus~     administration.~      Based on these findings, the purpose of this study is to evaluate safety and efficacy of~     prolonged administration of doxorubicin in combination with radiotherapy, temozolomide and~     valproic acid in pediatric and adult patients with newly diagnosed GBM and diffuse intrinsic~     pontine glioma (DIPG).~   "
61771|NCT02758353|"~     The purpose of this study is to test the feasibility of the scale-up of sulphadoxine-~     pyrimethamine (SP) for the preventive treatment of malaria in pregnancy in three Local~     Government Areas (LGAs) in Sokoto State, Nigeria. The scale-up strategy tested included the~     introduction of community-based distribution of SP in addition to ongoing health facility~     distribution during antenatal care (ANC) visits. In addition, the study examined for the~     effect of SP use by participants during pregnancy on the head circumference of live newborns~     and on the odds of a baby being a stillborn. Finally, the investigators also sought to~     quantify the costs associated with program scale up SP to deliver at least three doses of SP~     per participant via a government operated distribution program.~   "
61772|NCT02758340|"~     The study will compare the number of women who deliver vaginally after artificial initiation~     of labor pains(i.e. induction of labor) by two methods. Half of the women would receive~     tablet misoprostol vaginally and the other half would receive tablet misoprostol and foley's~     balloon catheter both.~   "
61773|NCT02758327|"~     The objective of the study is to demonstrate a change in osmolarity over time when moderate~     to severe dry eye subjects are treated with TheraTears lubricating drops.~   "
61774|NCT02758314|"~     Several reports have examined Programmed Death 1 (PD-1) expression on tumor-infiltrating~     T-cells, and its correlation with prognosis has been discussed. However, Programmed Death 1~     (PD1)/Programmed Death Ligand 1 (PDL1) expression on the peripheral blood T-cells of cancer~     patients, particularly in those with lung cancer, has not been sufficiently studied. The~     purpose of this study is evaluate the expression of PD1 and PDL1 in subpopulations of~     peripheral blood and tumor cells patients with lung cancer non-small cell (NSCLC),~     associating with clinicopathological features of the patients studied.~   "
61775|NCT02758301|"~     The purpose of the LINQ™ HF study is to characterize Reveal LINQ™ derived data from patients~     with heart failure by assessing the relationship between changes in LINQ™ derived data and~     other physiologic parameters with subsequent acute decompensated heart failure (ADHF) events.~   "
61776|NCT02758288|"~     The investigator's aim in this study is to evaluate the impact of a new standard of care~     protocol for the treatment of BK viremia and nephropathy (BKVAN), which includes switching~     from Tacrolimus to equivalent dose of Cyclosporine in patients who have been diagnosed with~     BK viremia or BKVAN based on their viral load, overall graft function (estimated glomerular~     filtration rate), acute rejection, and rate of graft loss due to rejection or BKVAN.~   "
61777|NCT02758275|"~     The purpose of this study is to improve the adherence of therapeutic regimen in people with~     hypertension arterial and/or diabetes mellitus type 2. Our hypothesis is the nursing~     intervention Teaching: Individual, is more effective to increase adherence of therapeutic~     regimen in people with hypertension arterial and/or diabetes mellitus type 2, than usual~     care.~   "
61778|NCT02758262|"~     The goal of this project is to identify brain mechanisms by which Noninvasive brain~     stimulation (NIBS) could decrease hyperphagia. The investigators will synchronously deliver~     NIBS and measure brain activity in a randomized, crossover, sham-controlled, fully blind~     study. This work will reveal brain mechanisms to reduce hyperphagia and may contribute to new~     therapeutic avenues to treat this eating disorder.~   "
61779|NCT02758249|"~     Anesthetics agents has an effect on immune response during the cancer surgery.This influence~     can regulatory to immune activity or cancer cell survival.~      The purpose of this study is to prove the variation of immune cell activity between~     preoperative and postoperative period.~   "
61780|NCT02758236|"~     This study is a prospective observational cohort study of TB patients who are treated or~     evaluated at 10 study sites. Patients presenting with cough for 2 weeks or longer with at~     least one additional TB symptom and a chest X-ray suggestive of TB, will be invited to be~     enrolled in the study. The signed informed consent will designate their willingness to~     participate on this study.~   "
61786|NCT02758158|"~     Thyroid cancer affects 6,000 Canadians each year. Nodules on the thyroid are detected using~     ultrasound imaging and surgery is the most common treatment. However, most nodules are~     benign, and therefore a biopsy is needed to decide whether surgery is necessary. Ultrasound~     imaging is very sensitive for localizing nodules, but does not differentiate between~     cancerous and benign ones. To address this limitation of US imaging, investigators have~     designed and constructed, in collaboration with Sogang University, Seoul, S. Korea, a novel~     imaging system that performs complimentary imaging modalities (ultrasound (US), photoacoustic~     (PA)) that could potentially help diagnose nodules without the need for biopsy and~     unnecessary surgery.~   "
61787|NCT02758145|"~     The investigators will compare two groups, an intervention group with a control group. Each~     employee of the University Hospital of Lausanne (CHUV) and the University Medical Policlinic~     of Lausanne (PMU) who will do his recruitment visit at the occupational medicine unit of the~     CHUV between 04/25/16 (end of previous influenza epidemic) and 31/10/16 (the day before the~     start of the next influenza vaccination campaign) and exert a function in regular contact~     with patients will be eligible. Depending on his employee number (assigned by the human~     resources administration, independent of any parameter), he will be placed in the~     intervention group G1 (odd number) or in the control group G2 (even number). The information~     concerning the distribution of these two groups will be noted in the computerized medical~     records of the employee at the occupational medicine unit (Medipho4D software, secured~     database). Thereafter, the employee will be received by the nurse of the he occupational~     medicine unit for a recruitment visit according to the usual process. The nurse will perform~     the study intervention in addition to the usual procedure if it is stipulated ''intervention~     group'' on the employee's record in the database or only perform the usual steps if it is~     stipulated ''control group''. At the beginning of the next influenza vaccination campaign~     (mid-November 2016), employees in the intervention group will receive a letter reminding then~     about the intervention given during the recruitment visit and inviting them to get~     vaccinated. During the next influenza vaccination campaign (11.01.16) and until the end of~     the influenza epidemic that will follow (April 2017), each employee will have the opportunity~     to be vaccinated at the different vaccination stalls set up by the occupational medicine~     unit. For each employee vaccinated, the date of vaccination and vaccine name is entered in~     the electronic medical records of the occupational medicine unit (Medipho4D software) by a~     nurse or a secretary of the unit. At the end of the human influenza epidemic (April 2017),~     the data will be extracted from the database (Medipho4D software) and anonymized by an~     individual not implicated in the study. Data from two groups will be analyzed and compared to~     assess whether the intervention conducted among newly hired employees promotes influenza~     vaccination.~   "
61788|NCT02758132|"~     This is a correlative study to characterize serum metabolites associated with bone~     deposition, growth and turnover in patients with newly diagnosed metastatic CRPC who are not~     currently receiving bone targeting agents.~   "
61789|NCT02758119|"~     The objective of this study is to compare two forms of pre-training (an online narrative~     presentation and a serious game) to prepare 2nd year medical students for a hands-on training~     with physical simulators about out-of-hospital cardiac arrest management.~   "
61790|NCT02758106|"~     BACKGROUND: Endotracheal intubation and prolonged immobilization of patients receiving~     mechanical ventilation may reduce expectoration function. High frequency chest wall~     oscillation (HFCWO) may ameliorate airway secretion movement; however, the vigorous~     oscillation may influence ventilator settings and change instantaneous cardiopulmonary~     responses. The aim of this study was to investigate these issues. METHODS: Seventy-three~     patients aged >20 years who were intubated with mechanical ventilation for pneumonic~     respiratory failure were recruited and randomly classified into two groups (HFCWO group,~     n=36; and control group who received conventional chest physical therapy (CCPT), n=37). HFCWO~     was applied with a fixed protocol, while CCPT was conducted using standard protocols. Both~     groups received sputum suction after the procedure. Changes in ventilator settings and the~     subjects' responses were measured at pre-set intervals and compared within groups and between~     groups.~   "
61791|NCT02758093|"~     As people age with HIV, the synergistic effects with normal age-related cognitive declines~     will accentuate and/or accelerate declines in cognitive functioning which can be detected as~     early in one's 40s. Although interventions are needed to protect/improve cognitive~     functioning, one intervention already exists to improve speed of processing. NINR/NIA~     (January 14, 2014) announced that Speed of Processing Training used in the ACTIVE Study (N =~     2,802 community-dwelling older adults) has the ability to enable older people to maintain~     their cognitive abilities as they age even 10 years after training. As shown in the ACTIVE~     Study, this intervention uniquely improves driving, instrumental activities of daily living~     (IADL), health-related quality of life, self-rated health, internal locus of control, and~     protects one from depression; these represent areas of needed intervention for adults with~     HIV as well. In adults with HIV, previous pilot studies likewise indicate speed of processing~     declines are associated with poorer driving simulator performance and more self-reported~     at-fault automobile crashes; such speed of processing declines on driving alone represent a~     significant public health concern. These studies also demonstrated that Speed of Processing~     Training improved this cognitive ability and translated into improved performance on a timed~     measure of IADLs. Based on prior research, this RCT proposal consists of a pre-post two-year~     longitudinal experimental design whereby 264 adults with HIV, 40+ years and diagnosed with~     HIV-Associated Neurocognitive Disorder, will be randomly assigned to one of three training~     conditions: 1) 10 hours of laboratory-based Speed of Processing Training, 2) 20 hours of~     laboratory-based Speed of Processing Training, or 3) 10 hours of a standardized~     computer-contact control (sham) condition.~      AIM 1: Determine whether 10 vs 20 hours of speed of processing training will improve this~     cognitive ability at post-test, year 1, and year 2 after baseline.~      AIM 2: Determine whether 10 vs 20 hours of speed of processing training will improve everyday~     functioning at post-test, year 1, and year 2 after baseline.~      Exploratory AIM: Determine whether improvement in speed in speed of processing and/or~     everyday functioning over time mediate improvement quality of life (e.g., depression, health~     related quality of life).~   "
61792|NCT02758080|"~     A molecular profile of a patient with hematologic malignancy, for whom standard-of-care had~     failed, is identified using next generation sequencing. Patients are assigned to early~     clinical trials of targeted agent based on the molecular profiling or physician's choice. The~     improvement of outcomes in the intention-to-treat population is investigated.~   "
61793|NCT02758067|"~     To demonstrate that the effectiveness of brexpiprazole (2-4 mg/day) on quality of life is~     non-inferior to that of risperidone (4-6 mg/day) in adult patients with schizophrenia.~   "
61794|NCT02758054|"~     The study proposes to evaluate a patient navigation intervention among a sample of 340~     individuals referred for CT-based lung cancer screening in an urban safety-net setting.~   "
61795|NCT02758041|"~     This study is proposed to evaluate Sebacia Microparticle treatment in patients with facial~     inflammatory acne vulgaris.~   "
61796|NCT02758028|"~     The aims of the present study are:~        1. To raise the awareness of smoking cessation service among youth smokers in Hong Kong;~        2. To provide smoking cessation quitline service to youth smokers; and~        3. To provide training to teenagers as peer smoking cessation counsellors.~        4. To examine the effectiveness of adventure-based training and WhatsApp messages in~          helping youth smokers to quit~   "
61797|NCT02758015|"~     Food will decrease stomach acidity due to its buffering effect.This has implications when~     providing drugs that are dosed with food but require higher levels of stomach acid, such as~     some medications commonly used for HIV patients. This study will attempt to determine the~     dose of betaine hydrochloride (over the counter acid supplement) at which the effect of food~     on stomach acid could be countered. Additionally, this study will evaluate the ability of a~     natural supplement (betaine hydrochloride) to affect the gastric pH following a standardized~     meal in healthy volunteers. The investigators predict that 4500mg of betaine hydrochloride~     will have the greatest effect on gastric pH.~   "
61798|NCT02758002|"~     There is growing awareness of the importance of electrical rotors to the maintenance of~     atrial fibrillation (AF). Recent work in our laboratory has found that AF evolves over time,~     from rapid, focal activation, next to transitional rotors, and finally to stable, long~     duration rotors, whose locations are frequently separate from the transitional rotor sites.~     This project will test the hypothesis that mapping and ablation of the transitional rotors~     sites may prevent atrial fibrillation from progressing to sustained atrial fibrillation, and~     therefore increase the AF initiation threshold. The investigators will test this hypothesis~     during clinically-indicated electrophysiology study prior to ablation of symptomatic AF.~   "
61799|NCT02757989|"~     Comparison of survival in patients with or without a matched donor at 36 months~   "
61800|NCT02757976|"~     This trial will compare two strategies for patients with Heart Failure, Left Ventricular~     systolic dysfunction, and intermediate QRS durations. The control group is conventional CRT.~     The experimental group is LVendo CRT~   "
61801|NCT02757963|"~     This non-randomized, interventional study will be conducted in a general practice setting to~     assess the utility of a benign prostatic enlargement (BPE)/benign prostatic obstruction (BPO)~     screening tool in conjunction with prostate specific antigen (PSA) in finding men confirmed~     to have BPH on full urologist assessment of diagnostic test results. The tool may help a~     General Practitioners (GP) to identify subjects who may have BPH for further tests and~     improve the speed of referrals to specialists when this is appropriate. The utility of the~     screening tool will be compared to the validated tool in wide clinical use, the International~     Prostate Symptom Score (IPSS). This study does not have any formal hypothesis in terms of the~     primary and secondary endpoint proportions. A BPE/BPO screening tool identifies lower urinary~     tract symptoms (LUTS) probably due to BPH in men not yet presenting with LUTS. The results of~     this screening tool will be used for further investigation. All subjects testing positive on~     the BPE/BPO screening tool (score >=3) tool or on the IPSS (score >=8) will be enrolled and~     offered a PSA test and urinalysis to establish a diagnosis of probable BPH (Part I-Visit 1).~     The GP may perform a digital rectal examination (DRE) which will be repeated by the urologist~     to confirm the diagnosis and to rule out an abnormality suggesting prostate cancer. The GP~     will make a diagnosis of probable BPH based upon screening results and lab tests which~     suggest that they are related to BPH and not other causes of such symptoms. The GP will phone~     the subject to report yes or no for probable BPH Part II (Visit 2). If the subject has~     probable BPH, the GP will schedule the subject for Visit 3 with an urologist. If the subject~     does not have probable BPH, then it will be considered that the subject has completed the~     study. Subjects that proceed to Part II (Visit 3) will be scheduled for a urology assessment~     performed by an urologist. This assessment includes a DRE and a brief physical exam and~     review of the PSA test, for a confirmatory diagnosis of BPH and estimation of risk of~     progression of BPH. Approximately 1,500 subjects presenting to a GP for reasons unrelated to~     this study will be screened for probable BPH to yield 500 subjects being referred to an~     urologist. The duration of the study will be 1 week (+/- 4 days) and up to 6 weeks to allow~     for GP and urologist visit scheduling.~   "
61802|NCT02757950|"~     The purpose of this study is to assess the safety of RefortrixTM (Tdap) when administered~     during pregnancy in a maternal immunization program in Brazil.~   "
61803|NCT02757937|"~     Diabetes is one of the most common chronic illnesses among adults in the United States.~     Internet-based interventions and health promotion websites for patients with Type 2 Diabetes~     are typically low-cost, easily accessible, and attractive. The purpose of this study is to~     determine whether participants' utilization of a health & wellness website focused on~     diabetes self-management increases participants' self-reported self-efficacy toward managing~     their Type 2 Diabetes through behavior change and self-reported medication adherence compared~     to standard care.~   "
61804|NCT02757924|"~     To observe the effects of partially hydrolyzed formula supplemented with oligosaccharides on~     symptoms of formula intolerance in healthy term infants.~   "
61805|NCT02757911|"~     X-linked chronic granulomatous disease (X-CGD) is a rare genetic disorder, which affects~     boys. It is a primary immunodeficiency disorder which results from an inability of the white~     blood cells called phagocytic cells (or phagocytes) to kill invading bacteria and fungi.~     These cells have difficulty forming the free radicals (most importantly the superoxide~     radical due to defective phagocyte NADPH oxidase complex) which are important in the killing~     of ingested pathogens. In X-CGD (which accounts for two thirds of CGD patients), the defect~     lies in a gene which makes up a critical part of the NADPH-oxidase complex (the catalytic~     subunit; gp91-phox protein). Therefore they kill bacteria and fungi poorly, and the patients~     suffer from severe and recurrent infections. This also results in inflammation which can~     damage parts of the body such as the lung and gut.~      In many cases, patients can be adequately protected from infection by constant intake of~     antibiotics. However, in others, severe life-threatening infections break through. In some~     cases, inflammation in the bowel or urinary systems results in blockages which cannot be~     treated with antibiotics, and which may require the use of other drugs such as steroids.~     Development of curative treatments for CGD is therefore of great importance.~   "
61806|NCT02757898|"~     The purpose of this research is to study how red blood cells (RBCs) survive in a person's~     circulation, and how that survival may be different in red blood cells that are donated and~     stored prior to being transfused. Investigators will study this by collecting blood samples~     from participants, labeling RBCs with a naturally occurring vitamin, biotin. The RBCs will~     then be re-infused back into the participant and blood samples will be taken weekly for 10~     weeks to assess the number of labeled cells in the samples.~   "
61807|NCT02757885|"~     The purpose of this study is to learn if it is possible and safe to treat persons with severe~     sickle cell disease (SCD) by bone marrow transplant (BMT) from human leukocyte antigen (HLA)~     half-matched related donors. Preparation before transplant includes the chemotherapy drugs~     hydroxyurea, fludarabine, thiotepa, anti-thymocyte globulin, and cyclophosphamide. It also~     includes radiation.~   "
61808|NCT02757872|"~     The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial~     in 25,875 US men and women investigating whether taking dietary supplements of vitamin D3~     (2000 IU) or omega-3 fatty acids (Omacor (R) fish oil, 1 gram) reduces the risk of developing~     cancer, heart disease, and stroke in people who do not have a prior history of these~     illnesses. The VITAL Kidney Function in Hypertension ancillary study will evaluate the~     effects of vitamin D or omega-3 fatty acids on kidney function among participants with~     baseline hypertension.~   "
61809|NCT02757859|"~     This randomized clinical trial studies how well high volume washing of the abdomen works in~     increasing survival after surgery in patients with pancreatic cancer that can be removed by~     surgery. High volume washings may remove free floating cancers present after surgery and help~     prolong survival in patients with pancreatic cancer.~   "
61810|NCT02757846|"~     We propose a radiomics approach to identify prognostic biomarkers of HCC and provide patients~     with some reasonable advice for their therapies.~   "
62036|NCT02754869|"~     This project involves the development, validation and application of a novel test using MRI~     to assess gastrointestinal motility a vital process that mixes the contents of our digestive~     tract. This process frequently becomes deranged in conditions like chronic constipation,~     Parkinson's and Crohn's disease.~   "
61814|NCT02757794|"~     Prematurity tends to increase in France in recent years and more children born extremely~     premature infants survive. If severe impairments have stabilized, the majority of former~     extremely premature children have neuropsychological disorders and moderate appearance~     behavior disorder, but with a significant impact both family, school and social persisting~     into adulthood.~      Executive functions (EF), in general, and working memory (MT), in particular, are frequently~     altered in older children preterm infants compared to controls born at term.~      The identification process of loss in certain diseases, as well as improving knowledge of~     brain functioning, and development with the possibility of neuronal plasticity has led~     research teams to develop intervention programs focused on process cognitive qualified of~     remediation cognitive (RC). Schematically, the RC is defined as a rehabilitation or altered~     cognitive functions. MT can be improved by encouraging the operation of the spots mental~     stimulant. These programs are effective on MT but do not have the expected impact on other~     FE, language or nonverbal functions (visuospatial). The functional benefit of cognitive~     remediation remains controversial.~      Improving mental functions untrained as nonverbal MT, attention and secondarily learning is~     possible but still unproven on wide population. Similarly, randomized trials are needed to~     test this type of cognitive remediation among preschoolers old very premature.~   "
61815|NCT02757781|"~     The eMPODERA study aims to assess the effectiveness of a Community of Practice (CdP) virtual~     in improving attitudes of primary care professionals on the empowerment of patients with~     chronic diseases.~   "
61816|NCT02757768|"~     The purpose of the study is to assess the efficacy, safety, and tolerability of mirabegron~     versus placebo in men with overactive bladder (OAB) symptoms while taking tamsulosin~     hydrochloride for lower urinary tract symptoms (LUTS) due to Benign Prostatic Hyperplasia~     (BPH).~   "
61817|NCT02757755|"~     This study will examine the safety of ascending doses of AB-SA01 when topically applied to~     intact skin of healthy adults.~   "
61818|NCT02757742|"~     The purpose of this study is to establish a quantitative LGE mass based scoring system~     (including LGE mass on cardiac magnetic resonance , clinical features, specific medical~     histories, et al) for risk prediction of sudden cardiac death in non-ischemic dilated~     cardiomyopathy patients with reduced left ventricular ejection fraction~   "
61819|NCT02757729|"~     This is a phase 2 study to investigate the safety and efficacy of PAC-14028 cream in Atopic~     Dermatitis patients.~   "
61820|NCT02757716|"~     To evaluate addiction remission and addiction transfer after bariatric surgery.~   "
61821|NCT02757703|"~     Various vasoactive drugs are recommended to use in combination with endoscopic variceal~     ligation (EVL) in treating acute esophageal variceal bleeding (EVB). The efficacy and drug~     choice of vasoactive agents under Taiwan's National Health Insurance program remain to be~     validated.~      The aim of this prospective cohort study was to assess the efficacy of somatostatin, compared~     with terlipressin in cirrhotic patients who have acute EVB and received EVL and the~     preference of vasoactive agents in real-world clinical practice.~      From April 2010 through April 2015, cirrhotic patients with significant upper~     gastrointestinal bleeding were screened. Eligible patients with acute EVB were non-randomly~     assigned to receive early administration of somatostatin (group S) or terlipressin (group T)~     infusion, followed by EVL. A decision to use vasoactive drugs depended on the physician's~     favorite. In group S, somatostatin by intravenous bolus (250 μg) followed by 250 μg/hour was~     continued for 3 days. In group T, terlipressin was started with 2mg bolus injection and~     followed by 1 mg infusion every 6 hours for 3 days.~   "
61822|NCT02757690|"~     Traditionally, laparoscopy has been based on 2-dimensional (2D) imaging, which has~     represented a considerable challenge for those approaching this technique. Thus,~     3-dimensional (3D) visualization technology for laparoscopy has been proposed, since the~     early 1990s, as a way to facilitate laparoscopic performance. However, early 3D laparoscopic~     technology was limited in terms of image quality, so that its use had not been implemented.~     More recently, industry has developed novel 3D systems where the imaging is similar to~     stereoscopic vision, in which the depth perception is achieved by different unique images~     received by each eye. Thus, more recent studies have suggested a possible advantage provided~     by these new 3D systems during laparoscopic performance. However, comparative assessments of~     new generation 3D vs 2D laparoscopy remain limited, especially in the hepatobiliary and~     pancreatic field.~      To assess the benefits and harms of use of three dimensional systems versus two dimensional~     systems during laparoscopic distal pancreatectomy.~   "
61823|NCT02757677|"~     The investigators aim to evaluate the efficacy of the new Optical Coherence Tomography based~     Angiography (OCT-A) softwares in the diagnosis and management of glaucoma.~   "
61824|NCT02757664|"~     Background: There is no consensus regarding the treatment of insertional tendinopathies. The~     good results of the eccentric training in the management of the non-insertional Achilles~     tendinopathy were not reproducible in the insertional disease. Shock wave therapy is~     described as an alternative to these patients.~      Hypothesis: The shock wave therapy allied to the eccentric strengthening protocol presents~     better results that the eccentric strengthening associated to placebo.~      Design: Double blinded (outcome assessor and patient) randomized clinical trial, with the use~     of placebo, in parallel groups.~      Materials and Methods: Nine-three patients with chronic insertional tendinopathy will be~     enrolled in a randomized trial. Participants will be divided in two groups, one containing~     the combination of shock wave and eccentric exercises as treatment and the other~     comprehending the exercises assembled to placebo. The assessment of outcomes will occur in 2,~     4, 6, 12 and 24 weeks of the beginning of the study. Patients will be evaluated for pain,~     activity and function by the VISA-A (the Victorian Institute of Sport Assessment-Achilles~     [VISA-A] questionnaire).~   "
61839|NCT02757469|"~     Premature ovarian insufficiency (POI) is a life-changing condition that affects women in~     their reproductive age. There is a lack of reports which focus on how to improve the~     reproductive outcome of these women who wish to conceive spontaneously or use assisted~     conception with their own oocytes. However, one could surmise that it is important to lower~     gonadotropin levels into the physiological range before embarking on any treatment, even if~     natural conception is the only choice for the woman/couple.~   "
62151|NCT02753374|"~     This study is a multicenter, prospective cohort study of patients diagnosed with cystic~     fibrosis, the clinical information of recruited patients, including clinical manifestations,~     lung function, chest imaging, quality of life and other indicators, will be followed for 10~     years.~   "
61825|NCT02757651|"~     This is a study aimed at testing a commonly available and inexpensive chemical (hydrogen~     peroxide) for safety and activity in sensitising large cancerous lumps in the breast to a~     standard course of radiotherapy in women with poorly controlled symptoms. Laboratory research~     and initial clinical trials in Japan suggest that 4 to 6 injections of a radiation sensitiser~     ('KORTUC') based on very dilute (0.5%) hydrogen peroxide injected into cancers under local~     anaesthetic twice a week during radiotherapy greatly increases the effectiveness of standard~     doses of radiotherapy alone. The side effects are limited to mild/moderate discomfort at the~     injection site for up to 24 hours reported by Japanese breast cancer patients in whom this~     treatment has been tested. Complete tumour shrinkage in 70/71 (98%) primary breast cancers up~     to 5 cm diameter have been reported by Japanese collaborators.~   "
61826|NCT02757638|"~     Understanding how foods and nutrients are digested, absorbed and metabolized when weight is~     stable and during weight loss induced by bariatric surgery procedure using the technologies~     of genomics, transcriptomics, proteomics, metabolomics and fluxomics (omics) will enable~     generation of new hypotheses that could explain the inter-individual differences in weight~     loss and could lead to optimization and individualization of therapies designed to lose~     weight.~   "
61827|NCT02757625|"~     To evaluate the efficacy, safety, and pharmacokinetics of dexmedetomidine given as continuous~     IV infusion in pediatric subjects [≥ 45 weeks CGA (corrected gestational age) to <17 years~     old] requiring sedation under intensive care unit~   "
61828|NCT02757612|"~     The aim of this study was to report the effect of laser diode on the treatment of burning~     mouth syndrome (BMS)~      Patients were randomly allocated to two different groups:~      the first one (group A) underwent Laser diode whereas the second one (group B) received Laser~     diode inactive~   "
61829|NCT02757599|"~     Background: Transvaginal ultrasound training of novices is performed differently with respect~     to the orientation of the ultrasound image. There is no international consensus on the~     orientation of the transvaginal ultrasound image and no evidence to support whether one~     orientation is superior to the other in terms of educational outcome and learning curves.~      The aim of this study is to assess the effects of transvaginal ultrasound training when~     orienting the image top-down versus bottom-up, which can open for the discussion concerning a~     uniform transvaginal ultrasound education. This study may improve ultrasound novices'~     learning and potentially ensure that future clinicians perform transvaginal ultrasound~     examinations in the same manner.~      Hypotheses: The investigators hypothesize that the orientation perceived by ultrasound~     novices, as the most intuitive will result in lower cognitive load during training and result~     in shorter learning curves and improved transfer of skills to various settings and cases.~   "
61830|NCT02757586|"~     CLL is a disease of the elderly, identifying effective therapies with better toxicity~     profiles is thus a high priority, and targeted therapies may allow attainment of this goal.~   "
61831|NCT02757573|"~     The aims of the study is to investigate the right ventricular responses to mild hypercarbia~     after mitral valve prolapse repair surgery by the measurements obtained on pulmonary arterial~     catheter and transesophageal echocardiography.~   "
61832|NCT02757560|"~     The overall goal of the proposal is to use a saturated fatty acid (SFA)- enriched, high fat~     diet to rapidly induce insulin resistance (IR) to provide insight into underlying proximal~     mechanisms of reduced insulin signaling. Specifically, investigators will identify the~     initial changes in metabolite concentrations/or pathway signaling (pathways will be used to~     broadly refer to these mechanism specific measures) and therefore the mechanisms most likely~     responsible for the development of IR during this high fat nutritional challenge.~     Investigators have assembled a multidisciplinary team that is versed with dietary studies,~     fatty acid metabolism, measurement of IR and potential mechanisms and mediators of IR, and~     has experience working with monocytes and the two tissues, muscle and adipose tissue, that~     are particularly relevant for understanding the effects of high fat diets on IR.~   "
61833|NCT02757547|"~     The goal of the present clinical trial is to determine whether low frequency (0.5 Hz) rTMS~     can induce long term depression in epileptogenic cortex and thus suppress cortical~     excitability at the epileptic focus.~   "
61834|NCT02757534|"~     The purpose of this study is to provide oral domperidone to patients with gastroparesis,~     between the ages of 18 and 60 years of age, who have failed standard treatment. Standard~     therapy at the University of Iowa is eating blended foods, liquid diet, Eryped syrup (125 mg~     TID) 30 minutes before meals, or reglan (20 mg BID).~   "
61835|NCT02757521|"~     Investigators will study approximately 64 patients with Treatment-Resistant Bipolar~     Depressive Disorder, defined as a failure of at least 1 antidepressants in the current~     depressive episode and 2 lifetime medication failures. The study will last approximately 6 to~     8 weeks, involving randomization into one of two treatment groups receiving 3 one hour long~     inhalation treatments over a week.~   "
61836|NCT02757508|"~     This study is to gather information on school feeding programs and to measure the effect on~     linear growth and cognitive performance when providing a high-quality milk protein source or~     a combination of a high-quality milk protein source and rice proteins as a nutritional~     supplement to school children in Ghana. Children will receive a meal with a protein powder~     supplement with vitamins and minerals mixed into it. Participation is expected to last for 9~     months.~      1200 Children aged 6-7 years attending school will be enrolled throughout twenty primary~     schools (60 per school). Participants will be randomized to one of four groups: Control:~     Vitamins/minerals-200 mg premix contain the required micronutrients as per UNICEF~     recommendations.~      For groups 1-3 the same vitamin/mineral mix will be used along with Group 1.~     Vitamins/minerals + Milk Protein (8.75 g)-the milk protein is a skim milk powder with the~     sugar lactose.~      Group 2. Vitamins/minerals + Milk/plant Protein (8.75g)-the milk protein is a skim milk~     protein powder and the plant protein is a rice protein concentrate and the sugar lactose.~      Group 3. Vitamins/minerals + Milk Protein (4.38g)-the milk protein is a skim milk protein~     powder with the sugar lactose.~      At baseline measurements-weight,height,mid-upper arm circumference,and body composition will~     be taken, fasting blood spot test will be administered to measure levels of Insulin and~     insulin like growth factor and other metabolic test, and computer based cognitive testing.~     Demographic information will be collected along with a dietary survey. Primary outcomes are~     cognitive performance on standardized tests and change in height-for-age z-score over the~     supplementation period, 9 months total. Questionnaires will be administered to collect~     demographic data and dietary information.~      At the mid-point all measurements will be taken again and cognitive testing will be repeated.~      At the end of the study all measurements will be taken again, cognitive testing repeated,~     blood spot samples taken again, and a short survey will be administered about the protein~     powders.~   "
61837|NCT02757495|"~     Emergence agitation (EA) is common phenomenon in pediatric patients undergoing general~     anesthesia by inhalation agents. The incidence of EA was reported to range from 18% to 80%.~     Sevoflurane now is the inhalational anesthetic agent of choice for pediatrics, Different~     strategies have been suggested to decrease the incidence and severity of EA. No gold standard~     technique for treating EA after sevoflurane anesthesia is currently available. The main~     question is can caudal dexmedetomidine be used for this purpose?~   "
61840|NCT02757456|"~     Arterial calcification is very common in the incident hemodialysis population, ranging~     71-83%.Given that cardiovascular disease is a major cause of mortality in the hemodialysis~     population, medial arterial calcification may contribute through increased risk of sudden~     death and congestive heart failure. Applanation tonometry is the method of choice to measure~     pulse wave velocity and pulse wave analysis. The primary objective will be to assess the~     effect of a 16 week exercise program on aortic pulse wave velocity as the vascular parameter~     and gait speed as the physical functioning parameter. The secondary objectives will assess~     the effect of the exercise program on ultrafiltration rates, weight, SBP, DBP, BNP,~     hsTroponin, serum calcium, phosphate, albumin, glucose, LDL, HDL, TG, glycated hemoglobin,~     hemoglobin, CRP, micro RNAs (21, 126, 133, 146a, 221/222 and 210) and hospitalizations.~   "
61841|NCT02757443|"~     There is evidence on the role of the phosphotransfer system in the energy metabolism of the~     heart, with altered energetics playing an important role in the mechanisms of heart failure.~     Phosphocreatine plays an important part in the energy heart system. The investigators have~     just performed a systematic review and meta-analysis of randomized controlled trials (RCTs)~     and matched studies that compared phosphocreatine with placebo or standard treatment in~     patients with coronary artery disease or chronic heart failure or in those undergoing cardiac~     surgery. Patients receiving phosphocreatine had lower all-cause mortality as well as improved~     cardiac outcomes when compared to the control group, however, the quality of the included~     studies was low. Thus, the investigators plan to conduct an exploratory high quality RCT to~     investigate whether providing phosphocreatine compared to placebo improves the myocardial~     protection in high-risk patients scheduled for cardiac surgery and to determine the best~     research endpoint for future trials.~   "
61842|NCT02757430|"~     The objective of this registry is to assess and characterize the use and performance of the~     EnSite Precision™ Cardiac Mapping System and the EnSite Precision™ Software V2.0 in a variety~     of electrophysiological (EP) procedures and clinical settings. This registry will assess the~     clinical performance of the system in a controlled, real-world environment after commercial~     release.~      Up to 500 subjects will be enrolled in up to 50 sites worldwide.~      Data will be collected at enrollment/baseline, procedure and pre-discharge. There is no~     long-term follow-up required for this registry.~      The anticipated registry enrollment is about 6-7 months.~   "
61843|NCT02757417|"~     To determine the safety profile of sodium fluorescein in women undergoing cystoscopy during~     gynecologic surgery. To determine if either oral phenazopyridine or sodium fluorescein result~     in shorter cystoscopy times.~   "
61844|NCT02757404|"~     Botulinum Toxin for the Treatment of Post Stroke Upper Limb Spasticity.~   "
61845|NCT02757391|"~     The goal of this clinical research study is to learn if it is safe to deliver a CD8+T cell~     therapy to patients with advanced gastrointestinal cancers.~      This study will use your tumor cells (either from a fresh biopsy or from leftover tissue~     samples) and blood to help create a T cell immune-based therapy designed specifically for you~     based on what the study doctor and research staff can learn about the type of mutated~     proteins (a type of genetic change) in the tumor.~   "
61846|NCT02757378|"~     This study evaluates whether different explanations given to patients with long lasting back~     pain influence a physical therapy treatment technique. Half of the patients will receive an~     explanation of the proposed treatment technique focusing on how their joints are moving and~     not moving. The second half of the group will receive the same treatment technique as the~     first group, but their explanation of the technique's purpose will focus on how their brain~     interprets the information. The study aims to determine if patients have a different response~     to the treatment based on the words chosen to explain the technique.~   "
61847|NCT02757365|"~     Though the pathogenesis of prostate cancer (PCa) is still obscure, it has been reported, by~     investigators previous studies and some other researches, that PCa is often combined with~     tissue inflammation which is closely related to prostate specific antigen (PSA) level.~     Inflammation could play an important role in the process of occurrence and development of~     PCa, however the mechanism is unknown. Inflammatory cytokines could not only mediate~     inflammatory reactions, but also participate in the growth, proliferation, invasion and~     progression of tumor cells. It has been found that non-steroid anti-inflammatory drugs~     (NSAIDs), such as aspirin, can effectively prevent several inflammation related tumor, and~     coincidentally, PCa is also closely associated with inflammation. Moreover, latest researches~     demonstrated that hormone therapy could induce tissue inflammation in PCa, in which a large~     quantity of immune B cells were attracted into the focal and then a lot of cytokines, such as~     IKK-β, NF-κB, were released. These cytokines could inhibit apoptosis and promote the growth~     of tumor cells, which might be a possible mechanism for long-term inflammatory infiltration~     inducing the occurrence of PCa and the transformation to castration-resistant prostate cancer~     (CRPC). Based on these proofs, investigators presume it could be possibly an effective way to~     prevent the occurrence of PCa and the transformation from androgen-dependent prostate cancer~     to CRPC by means of long-term oral aspirin. In this study, investigators intend to explore~     the possible effect of anti-inflammatory therapy on the progress of transformations from~     inflammation to PCa and from androgen-dependent prostate cancer to CRPC. Investigators plan~     to conduct both clinical trials in four groups, including the control group, the NSAIDs~     group, the antibiotics group and the NSAIDs+antibiotics group, and a basic experiment in~     vitro to assess the effectiveness of anti-inflammatory drugs and elucidate the specific~     molecular mechanism.~   "
61848|NCT02757352|"~     The main purpose of this study is to evaluate the safety and efficacy of the study drug known~     as ixekizumab in biologic disease modifying antirheumatic drug (bDMARD) naïve participants~     with nonradiographic axial spondyloarthritis (nonrad-axSpA).~   "
61849|NCT02757339|"~     This study aims to evaluate the neurobiological basis of traumatic dissociation in a~     cross-diagnostic sample of women who have histories of childhood abuse and neglect.~   "
61856|NCT02757248|"~     This is a phase I study of the combination of volasertib and romidepsin in patients with~     relapsed/refractory peripheral T cell lymphoma (PTCL) or stage IIB-IV cutaneous T cell~     lymphoma (CTCL). This study will determine the maximum tolerated dose (MTD) of this~     combination by treating cohorts of patients at a certain dose combination. The investigators~     will use a Bayesian design to determine the dose combination for the next cohort of patients~     and to determine the MTD. Overall response rate as well as adverse events will be monitored~     and reported.~   "
61857|NCT02757235|"~     The study will be a multicenter randomised controlled trial of the use of irrigation fluid of~     body temperature versus irrigation fluid of room temperature during burr hole evacuation of~     chronic subdural hematoma.~   "
61858|NCT02757222|"~     The primary objective of the study is to establish the safety of using a moderate escalation~     of radiotherapy dose in advanced/poor prognosis OPC and LH cancers receiving curative~     radiotherapy.~      The study will also explore the efficacy (improvement in complete response rates at 2 years)~     of dose escalation in intermediate and high risk OPC and LH cancers patients.~   "
61850|NCT02757326|"~     This is a Phase Ib/II safety and efficacy trial of single agent ABC294640, an inhibitor of~     sphingosine kinase 2 and dihydroceramide desaturase, in refractory or relapsed multiple~     myeloma (MM). Cohorts of patients with refractory or relapsed MM who have previously been~     treated with proteasome inhibitors and immunomodulatory agents will receive increasing doses~     of oral ABC294640. The starting dosage for ABC294640 will be 250 mg bis in die (BID) which is~     known to be safely tolerated as a single agent, and the ABC294640 dose will be escalated to~     two additional dose cohorts of 500 and 750 mg BID using Bayesian model average continual~     reassessment method (BMA-CRM) for dose finding. It is expected that 18 patients will be used~     to determine the maximum tolerated dose (MTD) for ABC294640 in refractory or relapsed MM. Up~     to 56 additional patients will be treated on the phase II portion of the study at the MTD or~     maximum dose used in phase I, with interim stopping rules for futility.~      Pharmacokinetic (PK) and pharmacodynamic (PD) assessments of ABC294640 will be conducted on~     Day 1 of Cycle 1. Bone marrow biopsy will be obtained prior to the initiation of ABC294640,~     at the end of cycle #3 and at the end of cycle #6. In addition to serum protein~     electrophoresis (SPEP), urine protein electrophoresis (UPEP) and serum free light chain~     measurement, correlative studies will be performed to measure sphingosine kinase 2 (SK2)~     activity, sphingosine metabolites, and additional biomarkers in CD138+ myeloma cells.~   "
61851|NCT02757313|"~     Marijuana is one of the most widely used substances. However, marijuana intoxication is not~     fully understood in relation to driving. This study will help the investigators learn more~     about the potential impairments related to marijuana intoxicated driving. A combination of~     MRI and neuropsychological tests (which are computer and paper/pencil tasks) will be used to~     measure intoxication and impairment. This study will also assess levels of marijuana in blood~     and saliva samples. This study takes place in Hartford, Connecticut.~   "
61852|NCT02757300|"~     After approval of the Institutional Review Board and written patient´s informed consent~     patients with indication for surgery of the sinuses were randomly assigned to one of the two~     study groups. After standardized anaesthetic management and PONV prophylaxis routinely~     applied the patients were screened for mucosal injury on second postoperative day.~     Furthermore, the amount of analgetic and anti-emetic drugs and the severity of pain and PONV~     were recorded throughout the hospital stay.~   "
61853|NCT02757287|"~     Currently, controlled ovarian stimulation (COS) in oocyte donors is performed by daily~     injections of gonadotropins( recombinant FSH) plus a GnRH Antagonist usually form 5th-6th~     stimulation day until ovulation induction with a bolus of another injection of a~     gonadotropin-releasing hormone (GnRH) Agonist. Injections of the GnRH Antagonist avoid~     untimely luteinizing hormone (LH) surge and spontaneous ovulation prior to follicular~     aspiration. There is a preparation of long-acting recombinant follicle stimulating hormone~     (rFSH= (corifollitropin alfa (FSH-CTP), Elonva®, MSD), that allows that a single subcutaneous~     injection substitutes the first 7 days of daily gonadotropin injections. On the other hand, a~     contraceptive oral progesterone only( Desogestrel, DSG) is available for contraception,~     avoiding the LH surge. It has been described the usefulness of orally administered~     medroxyprogesterone acetate, 10 mg to inhibit the endogenous LH surge in IVF patients during~     COS.~      In donors, by administering a single injection of FSH-CTP and oral desogestrel since the~     first menstruation day, the total number of injections administered is reduced and less~     discomfort is experienced without adverse impact on ovarian response. No description of the~     hormonal and ovarian response under this protocol has been published~   "
61854|NCT02757274|"~     This will be a prospective collection of pre-defined parameters on the treatment of male~     stress urinary incontinence by an artificial urinary sphincter (AUS) and male sling. The data~     collection will be undertaken from multiple centers in Europe. The participation will be by~     open invitation to all members of the Female & Functional Section of the EAU (ESFFU) along~     with other urologists undertaking these procedures. There will be a call via the European~     Association of urology (EAU) to all European Urologists to register for database entry. There~     will be no restriction on the number of patients enrolled as long as they are consecutive.~     The aim is to have a long term collection of the data set from as many centers as possible.~     An initial assessment for the robustness of the data collection will be undertaken at 3~     months by a nominated steering committee. However, the first clinical evaluation of the data~     collected will commence at 1 year by the steering committee. Thereafter, the evaluations will~     be performed after every 2 years.~   "
61855|NCT02757261|"~     Bruxism is a repetitive activity of the masticatory muscles characterized by grinding and/or~     clenching one's teeth or parafunctional movements of the mandible. The aim of the proposed~     controlled clinical trial is to evaluate muscle activity, bite force and salivary cortisol in~     children aged six to eight years with bruxism. The children will be randomly allocated to~     four groups, each with 19 participants: Group 1 will receive low-level laser therapy at~     acupuncture points; Group 2 will use an occlusal splint; Group 3 will receive placebo laser~     therapy; and Group 4 will be the control group without bruxism. Low-level laser (786.94 nm,~     0.04 cm2, 70 mW and 20 s per points) will be applied directly on the skin at six acupuncture~     points on each side. The BTS TMJOINT electromyograph will be used to determine muscle~     activity and a digital gnathodynamometer will be used to measure bite force. Two saliva~     collections will be performed in the participant's home at 9 am and prior to going to sleep,~     with at least one hour of fasting and followed by oral hygiene with water. Evaluations will~     be performed before as well as one and six months after treatment. The findings will be~     computed and submitted to statistical analysis. Descriptive statistics will be used first for~     the determination of point estimates, precision and validation using analysis of variance~     (ANOVA) for the evaluation of residuals and parametric tests will be used for the~     determination of pre-treatment conditions. Interval estimates will be used for the variables~     of interest to determine the prevision of the estimates and perform comparisons. When~     necessary, transformation methods or non-parametric tests will be used in the data analysis.~     The chi-square test, Student's t-test and ANOVA will be employed, with the level of~     significance set at 5% (p < 0.05).~   "
61859|NCT02757209|"~     This is a randomized, multi-center, active-controlled, repeated measures design study in male~     and female patients 60 years of age and older with persistent asthma or COPD.~      Study will be conducted in 4 Italian University/Hospital Centers: Ferrara, Parma, Cassano~     delle Murge (Ba), Tradate.~      The primary efficacy parameter of the study is inhaler device usability (expressed as total~     number of repeated attempts required to achieve optimal use).~   "
61862|NCT02757170|"~     Patients of acute & chronic liver failure have long been assumed to have coagulopathy & are~     given blood products prophylactically as well as during various interventions. But these~     patients rarely have spontaneous bleed except variceal bleed. Conventional coagulation~     parameters are insufficient to assess coagulation status of these patients because they~     reflect only a certain element of coagulation cascade while thromboelastography (TEG) gives a~     comprehensive report of hemostatic profile including platelet function. Studies using TEG~     have suggested that defects in prohemostatic drivers are counterbalanced by changes in~     antihemostatic drivers creating a rebalance in these patients. Acute on chronic failure is a~     entity with acute decompensation on underlying chronic liver failure. Since there is paucity~     of data regarding coagulation abnormalities in these patient, study is needed to assess~     predictability power of TEG in these patients with respect to coagulation abnormalities in~     patient with ALF and CLD ( cirrhosis) and healthy controls.~   "
61863|NCT02757157|"~     The purpose of this study is to evaluate the metabolic load during a single session of~     moderate intensity walking in water compared to walking on land (over-ground) in people with~     chronic obstructive pulmonary disease (COPD) who are normal weight and obese, compared with~     peak exercise metabolic response.~      The hypothesis is that the metabolic load of walking at a moderate intensity in water will be~     greater than walking on land.~   "
61864|NCT02757144|"~     This is a dose block-randomized, double-blind, placebo- and active-controlled, single and~     multiple dosing, dose-escalation clinical phase 1 trial to investigate the safety,~     tolerability, pharmacokinetics and pharmacodynamics of DWP14012 after oral administration in~     healthy male volunteers.~   "
61865|NCT02757131|"~     Bedrest and lack of mobility in the inpatient hospital setting hastens the functional decline~     of elderly patients and is associated with increased risk of complications such as falls,~     delirium, venous thrombosis, and skin breakdown. These adverse health effects drive increased~     cost as patients spend additional time in both the acute (hospital) and post-acute care~     settings. Physical activity is thus widely recognized as an important factor for improving~     outcomes in hospitalized patients; however, numerous challenges to its implementation exist.~     Specifically, although it has been found that with small increases in physical activity such~     as increasing number of steps by only 600 daily for inpatients, length of stay can be reduced~     by nearly 2 days, usual care in many hospitals, including the Cleveland Clinic, does not~     include exercise, and physicians do not all regularly order physical activity for their~     hospitalized patients. Even when activity is recommended or ordered, compliance and execution~     of the orders has been spotty and/or negligible. It is therefore clear that the current~     system for the provision of ambulation is ineffective. The investigators hypothesize that a~     graded protocol of ambulation which can be implemented by a dedicated patient care nursing~     assistant (PCNA) multiple times daily will provide significant benefit to patients without~     the labor and cost requirements of full-time nursing and physical therapy expertise. The~     objective of this study is to assess the feasibility and effectiveness of dedicated~     ambulator-assisted physical activity in elderly inpatients. The primary hypothesis is that an~     ambulator-assisted intervention for hospitalized elderly inpatients will prove feasible and~     may result in improved hospital outcomes, including less need for inpatient rehabilitation~     and shorter length of stay in the hospital. This study will provide pilot data for a larger~     randomized trial.~   "
61866|NCT02757118|"~     After obtaining approval from the Institutional Review Board of our institution, written~     informed consent is obtained from patients undergoing cardiac surgery are enrolled in this~     prospective study and randomly allocated into one of two groups: Group-C (n=15) and Group-HES~     (n=15).~      All recruited patients will be given patient identification number (PIN) for the present~     study of 01-30 according to their order of interview and recruitment. Investigators will~     prepare 15 yellow and 15 green cards, which will be inserted in 30 thick-paper envelopes.~     Then, all envelopes will be sealed, mixed and randomly allocated to get numbers of 01 to 30~     (Envelop number). After printing the envelope number outside envelope, all sealed envelopes~     with cards will be conveyed to and kept in pharmacy department.~      According to the color of the card, attending anesthesiologists will give crystalloid for~     yellow card or HES for green cards, respectively, to maintain stroke volume variation < 15~     during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture.~      Patient data and statistical analyses:~      Patient's data whole blood viscosity, PaO2, FiO2, Hemoglobin, urine amount, s-glucose will be~     determined from the patients' medical record after patient's discharge.~      All statistical analyses will be performed after the 30th patient's discharge and data~     acquisition~   "
61867|NCT02757105|"~     This is a randomized, double-blind, placebo-controlled, 2-arm parallel group study. After~     qualifying for the study and signing informed consent, patients will undergo a two-week~     observation period during which stool consistency and frequency data and symptom data will be~     collected. Patients will then be randomized 60:40 to RHB-102 12 mg (BEKINDA) or placebo.~     Patients will continue on treatment for 8 weeks. Each medication will be given once daily.~   "
61868|NCT02757092|"~     Pulmonary rehabilitation has been demonstrated by evidence-base medicine to reduce the~     pulmonary complications after thoracic surgery. According to the literature reviews, these~     studies did not specifically point out the proper timing for the intervention of pulmonary~     rehabilitation on patients with thoracic surgery; moreover, interventions about pulmonary~     rehabilitation that focused on long-term training have not been studied. The purpose of this~     study is to determine whether Pulmonary rehabilitation are effective on patients who had~     thoracic surgeries.~   "
61869|NCT02757079|"~     The purpose of this study is to evaluate the efficacy on sleep latency with electronic sleep~     diaries and the safety of NPC-15.~   "
61870|NCT02757066|"~     The purpose of this study is to verify the efficacy of NPC-15 (melatonin 1 mg/d or 4 mg/d)~     versus placebo to sleep latency with electronic sleep diaries.~   "
61871|NCT02757053|"~     Screening Brain magnetic resonance imaging (MRI) with Fluid-attenuated Inversion Recovery~     (FLAIR) and Susceptibility Weighted Imaging (SWI) sequences will be performed pre and post~     season on high school football players. One set of players will wear the Guardian Cap on~     their five star rated helmets and the other will wear five star rated helmets only. The~     investigators will compare outcomes of ImPACT scores and MRI findings between the two groups~     to see if there is a statistical difference in reduction of injury and to establish what the~     baseline level of MRI findings related to injury from high school football is as well as what~     the baseline level of injury is prior to the start of the season.~   "
61872|NCT02757040|"~     The purpose of this study is to determine whether the combination of As2O3 and ibrutinib is~     synergistic in chronic lymphocytic leukemia~   "
61931|NCT02756273|"~     During the creation of an ileostomy, a bridge device is systematically placed in an aim to~     reduce wound and peritoneal contamination by stools. Nevertheless no evidence was reported to~     justify this issue.~      Moreover the placement of a bridge device increases the difficulty of nurse cares and is~     associated with its own morbidity.~   "
61873|NCT02757027|"~     After obtaining approval from the Institutional Review Board of our institution, written~     informed consent is obtained from patients undergoing CABG surgery are enrolled in this~     prospective study and randomly allocated into one of two groups: Group-C (n=15) and Group-HES~     (n=15).~      All recruited patients will be given patient identification number (PIN) for the present~     study of 01-30 according to their order of interview and recruitment. Investigators will~     prepare 15 yellow and 15 green cards, which will be inserted in 30 thick-paper envelopes.~     Then, all envelopes will be sealed, mixed and randomly allocated to get numbers of 01 to 30~     (Envelop number).~      According to the color of the card, attending anesthesiologists will give crystalloid for~     yellow card or HES for green cards, respectively, to maintain stroke volume variation < 15~     during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture.~      Patient data and statistical analyses:~      Patient's data whole blood viscosity, PaO2, FiO2, Hemoglobin, urine amount, s-glucose will be~     determined from the patients' medical record after patient's discharge.~      All statistical analyses will be performed after the 30th patient's discharge and data~     acquisition~   "
61874|NCT02757014|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
61875|NCT02757001|"~     Spanish registry of retrievable vena cava filters.~      This registry is sponsored by the Spanish Society of Vascular and Interventional Radiology~     (SERVEI) and conducted by the Research Group GITMI (Group of Research in Minimally Invasive~     Techniques) of the University of Zaragoza (Spain).~      A software tool hosted on the official website of SERVEI and the journal Intervencionismo~     will be used for data collection a(https://estudios.watsoncme.com).~   "
61876|NCT02756988|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
61877|NCT02756975|"~     Prostate tissue biopsy is performed with either transrectal or transperineal approach. These~     two methods are usually based on tissue sampling with an ultrasound-guided core needle~     biopsy. Transperineal prostate biopsy can be done either with a conventional noncoaxial~     technique or with a coaxial technique. In conventional transperineal technique, biopsy needle~     is inserted repeatedly for each tissue sampling. Alternatively, a coaxial needle can be~     placed over the perineum; then, the direction of the biopsy can be changed by tilting the~     coaxial needle. In this prospective study, the investigators sought to compare the procedural~     time and the complication rate of coaxial technique with those of noncoaxial technique in~     transperineal prostate biopsy.~   "
61878|NCT02756962|"~     The investigators will prospectively determine whether the relapse-free and overall survival~     in patients who have cleared their leukemia-associated mutations treated with standard~     consolidation chemotherapy is superior to what is expected based on historical controls. The~     investigators will also prospectively determine the relapse-free and overall survival of~     patients who have not cleared their mutations. Because the relapse rate of patients with~     persistent mutations is expected to be high, treatment with either standard of care~     consolidation therapy alone or alloSCT will be permitted, at the discretion of the treating~     physician.~   "
61879|NCT02756949|"~     This randomized controlled trial evaluates the provision of individual patient laboratory~     results to newly diagnosed HIV positive smartphone users through a secure application (app)~     as a method to get them linked to and retained in care, and engage with educational materials~     purposefully developed to explain their results. Message prompts will also be used to alert~     patients that their results are ready and provide information on how to link to care, and~     assistance to re-link to care if they fall out of the health system for any reason. Prompts~     will be sent to patients to remind health care workers if they are due for repeat laboratory~     monitoring. The primary endpoint is linkage to care (a HIV-related laboratory test) at 6~     months. The control group received standard of care.~   "
61880|NCT02756936|"~     An open label randomized, single dose, two-way crossover bioequivalence study to determine~     the bioequivalence of Daclatasvir from Daclatasvir zeta 60 mg F.C.T ( Zeta Pharm~     Pharmaceutical Industries, Egypt) versus Clatazev 60 mg F.C.T (Bristol-Myers Squibb Pharma,~     UK) in Healthy Human Volunteers Under Fasting Condition~   "
61881|NCT02756923|"~     Investigative trial to evaluate the role of a glial cell lined derived neurotrophic factor~     (GDNF) in regulation of spermatogonial renewal and testicular function. Goal of the trial is~     to provide greater information on the mechanisms that effect stem spermatogonial maintenance~     renewal and proliferation in its relation to male infertility.~   "
61882|NCT02756910|"~     A new wireless axillary thermometer from Raiing Medical uses a proprietary system,~     iThermonitor (WT701), to provide better estimates of core temperature than a conventional~     axillary probe. Improvement results in part because the axillary probe measures and records~     temperatures continuously every 4 seconds and includes software to compensate for ambient~     temperature and positional changes including arm abduction.~      Whether the iThermonitor is sufficiently accurate for clinical use remains unknown. The~     investigators thus propose to evaluate the system in perioperative patients who often~     experience thermal perturbations over a range of several °C. Specifically, the investigators~     propose to determine the precision and accuracy of iThermonitor in surgical patients and~     during the initial hour of recovery. As in previous studies, the investigators will consider~     the thermometer sufficiently accurate for clinical use if most Raiing temperatures are within~     ±0.5°C of the reference temperature.~   "
61883|NCT02756897|"~     The goal of this clinical research study is to learn if venetoclax given in combination with~     ibrutinib can help to control CLL or SLL. The safety of the drug combination will be also~     studied.~      This is an investigational study. Ibrutinib is FDA approved and commercially available for~     the treatment of patients with mantle cell lymphoma and in patients with CLL who have~     received at least 1 prior treatment. Its use in this study is investigational. Venetoclax is~     FDA approved and commercially available for the treatment of patients with CLL who have have~     received at least 1 prior treatment. The combination of venetoclax and ibrutinib is~     investigational.~      The study doctor can describe how the study drugs are designed to work.~      Up to 160 participants will be enrolled in this study. All will take part at MD Anderson.~   "
61982|NCT02755597|"~     This is a Phase 3, multicenter, randomized, double blind, placebo-controlled study evaluating~     the efficacy and safety of venetoclax plus bortezomib and dexamethasone in subjects with~     relapsed or refractory multiple myeloma who are considered sensitive or naïve to proteasome~     inhibitors and received 1 to 3 prior lines of therapy for multiple myeloma.~   "
61884|NCT02756884|"~     This is a single center, open label, prospective, randomized, controlled study in patients~     with non- revascularizable moderate or severe lower extremity Peripheral Arterial Disease~     (PAD) receiving autologous stem cells therapy (minimally manipulated). This study will enroll~     a maximum of 10 subjects in this study. The patients will be divided into two groups. One~     group will receive Adipose Derived Stem Cells (ADSCs) alone and the other group will receive~     low frequency ultrasound before the addition of ADSCs. The randomization will be 1:1. If the~     results of this pilot study are not clearly different, there will be a need for a phase II~     study to support the results.~      Baseline, 6 week, 3 month and 6 month assessments of 6 min walking distance (6MWT), Ankle~     Brachial Indexes (ABIs)/Toe Brachial Indexes (TBIs), Transcutaneous Partial Oxygenation~     (TcPO2) and Rutherford assessments will be performed for the study group. Prior to the stem~     cell treatment, the ultrasound group patient will receive noninvasive transcutaneous pulsed~     focused ultrasound around the involved vessel(s) in the affected extremity. All patients will~     then receive 200 million autologous stromal vascular fraction cells containing adipose~     derived stem cell therapy: 1/3 of the cells will be delivered intra-venous proximal to the~     lesion (not retrograde), 1/3 of the cells will be delivered intra- adventitia proximal to the~     lesion and 1/3 of the cells will be delivered by intra- muscular injection along the vessel~     path (20-30 injections each separated by1.5 inch). Standard therapy for PAD patients will not~     be interrupted for the duration of the study. Standard therapy for PAD is defined as~     cardiovascular general measures like lifestyle changes, smoke cessation, exercise,~     cardiovascular rehabilitation, etc. All participants have already received maximal~     non-surgical therapy. Safety will be monitored on an ongoing basis.~   "
61885|NCT02756871|"~     The purpose of this study is to assess the effectiveness of CBT based online guided self-help~     intervention for perfectionism at reducing symptoms of perfectionism and Axis I disorders~     post-treatment and at six-month follow-up.~   "
61886|NCT02756858|"~     This open label extension study is designed to provide continued access to ANAVEX 2-73 for~     eligible subjects with mild to moderate Alzheimer's Disease who have previously participated~     in the Anavex sponsored study ANAVEX2-73-002.~   "
61887|NCT02756845|"~     This is a phase 1 study to evaluate the safety of intralesional talimogene laherparepvec~     administration in pediatric subjects with advanced non-CNS tumors that are amenable to direct~     injection~   "
61888|NCT02756832|"~     The purpose of this study is to observe clinical response to treatment with alogliptin~     benzoate (Vipidia) utilization patterns in standard clinical practice.~   "
61889|NCT02756819|"~     The purpose of this study is to estimate antihypertensive effect of azilsartan medoxomil~     (Edarbi®) therapy on blood pressure in participants with overweight or obesity in routine~     clinical practice of hypertension (HTN) treatment in the Russian Federation and in the~     Republic of Kazakhstan..~   "
61890|NCT02756806|"~     Evaluate safety and efficacy with the enlighten laser for tattoo removal.~   "
61891|NCT02756793|"~     A multicenter randomized phase II trial of stereotactic body radiotherapy for~     oligo-progressive non-small cell lung cancer. Eligible patients will be randomized in a 1:2~     ratio between receiving their standard of care therapy or stereotactic ablative radiotherapy~     (SABR) to all sites of oligo-progressive lesions.Radiotherapy will be administered as soon as~     possible following randomization, and subjects will be followed until next disease~     progression. The primary outcome is progression-free survival (PFS).~   "
61892|NCT02756780|"~     'Sing With Us' choirs are an initiative established in Wales by Tenovus Cancer Care to~     provide social support and improve mental wellbeing amongst those affected by cancer, whether~     patients, carers or staff. Research has already demonstrated that these choirs can reduce~     depression and anxiety amongst participants and improve social support networks and quality~     of life as well as preliminary evidence that they can reduce levels of stress hormones and~     improve immune function. The aim of this study is to establish more about the psychological~     benefits of regular choir singing and explore whether the biological changes noted in pilot~     studies can be sustained over time. This could identify whether choirs have the potential to~     optimise health in people affected by cancer, helping to put patients in the best position to~     receive treatment or maintain remission and supporting those who care for someone with~     cancer, whether professionally or informally.~   "
61893|NCT02756767|"~     The goals of this study are to assess the feasibility of weekly administration of site~     specific patient reported assessments using an electronic platform and to explore the~     correlation between patient reported outcomes as well as known dosimetric prognostic factors~     in patients with lung, breast, head and neck, or pelvic malignancies~   "
61894|NCT02756754|"~     The aim of the study is to evaluate the novel use of adrenal radiofrequency ablation on a~     prospective cohort of patients with primary aldosteronism and unilateral adrenal adenoma~     concerning the efficacy on blood pressure control. The safety of the procedure is one of the~     secondary outcomes.~   "
61895|NCT02756741|"~     The standard recommended management of spontaneous bacterial peritonitis (SBP) includes a~     third-generation cephalosporin (cefotaxime or ceftriaxone) and high dose albumin (1.5g/kg on~     day 1 and 1g/kg on day 3). The major drawback of the current recommendations is the high~     price of albumin. In the current randomized control trial investigators compared the effect~     of standard recommended dose of albumin (1.5g/kg on day 1 and 1g/kg on day 3) vs. low dose~     (20g/d for 5 days) on the resolution of SBP and subsequent cytokine changes in ascitic fluid~     and blood.~   "
61896|NCT02756728|"~     The purpose of this study is to investigate the safety and efficacy of administering BI-505~     in conjunction with high dose melphalan and stem cell transplantation in multiple myeloma~     patients.~   "
61897|NCT02756715|"~     Ischeic reperfusion injury lead to a cellular dyfunction and increase in soluble glycocalyx~     of blood flow. syndecan-1 was a marker of glycocalyx.~      The purpose of this study is to prove the variation of level of serum syndecan-1 between~     preoperative and postoperative period.~   "
61898|NCT02756702|"~     Obligatory Post-Marketing Clinical Follow-up (PMCF) as part of the post marketing~     surveillance plan for the product under investigation For this PMCF only CE-marked medical~     devices will be used within their intended purpose and no additional invasive or other~     stressful examinations are to be carried out (acc. to MPG §23b).~   "
61899|NCT02756689|"~     The investigators are performing a randomized controlled-trial investigating starting~     cervical ripening in the outpatient setting with a mechanical method, the transcervical Foley~     catheter. This is a pilot study to establish the efficacy of this method in decreasing time~     as in inpatient and evaluate patient satisfaction.~   "
61900|NCT02756676|"~     This study is aimed to evaluate the impact of an intensive, multidisciplinary rehabilitative~     program on quality of life in patients with Parkinson's Disease.~   "
62783|NCT02745093|"~     The purpose of this study is to assess the effectiveness, safety, and acceptability of~     home-administered medical abortion at gestational age of 8 to ≤9 weeks versus >9 to ≤12 weeks~     among a cohort of women in Mexico City.~   "
61901|NCT02756663|"~     The purpose of this study is to investigate the anti-myeloma effect of panobinostat given at~     two different doses (10 mg and 20 mg oral) in combination with carfilzomib (20/56 mg/m2 i.v.)~     and low dose dexamethasone (20 mg oral) vs carfilzomib plus low-dose dexamethasone in~     patients with relapsed or relapsed and refractory multiple myeloma. Safety and efficacy will~     be evaluated. Treatment will be administered in 4-week cycles until patients discontinue due~     to disease progression or unacceptable toxicity or for other reasons.~      Patients who discontinue the study treatment for reasons other than documented disease~     progression will be followed for disease assessments every 8 weeks until progression. All~     patients will be followed for survival until 3 years have passed from their entry into the~     study, or they have discontinued the follow up earlier.~   "
61902|NCT02756650|"~     Primary objective of the study is to evaluate the safety and efficacy of canakinumab on the~     clinical and inflammatory findings of Behced Disease patients with neurologic and vascular~     involvement.~   "
61903|NCT02756637|"~     The purpose of this study is to perform a secondary analysis of SWOG 8710 to assess NLRs~     value as a biomarker. Specifically, the investigators test two hypotheses: 1) that baseline~     NLR is correlated with overall survival after curative treatment for BC and 2) that baseline~     NLR is correlated with the survival benefit of NAC. The study will look at the data from~     participants of the SWOG 8710 study.~   "
61904|NCT02756624|"~     This is study is evaluating the safety and tolerability of AC-170 Ophthalmic Solution~   "
61905|NCT02756611|"~     The purpose of this open-label, single-arm study is to evaluate the efficacy of venetoclax~     monotherapy in approximately 250 participants with relapsed/refractory CLL including those~     with the 17p deletion or TP53 mutation (assessed by local lab) OR those who have received~     prior treatment with a B-cell receptor inhibitor. The starting dose of venetoclax is 20 mg~     once daily. The dose must be gradually increased over a period of 5 weeks up to the daily~     dose of 400 mg. Participants may continue receiving venetoclax for up to 2 years. After the~     treatment period, participants may continue on into a 2-year follow-up period.~   "
61906|NCT02756598|"~     Patients scheduled for elective cardiac surgery are preoperative evaluated using different~     personality type, stress and anxiety tests.~      Patient are randomized to receive the investigators' standard moderate dose sufentanil (bolus~     1microgram/kg and propofol 0.03 mg/kg/min) or low dose sufentanil (bolus 0.5 microgram/kg and~     propofol 0.06 mg/kg/min).~   "
61907|NCT02756585|"~     Traumatic brain injury (TBI) is a leading cause of post-injury hospitalization, disability,~     and death worldwide. In Nova Scotia, approximately 50% of major trauma reported is head~     trauma. TBI is predicted to be the most common and expensive neurological condition in Canada~     through the year 2031.~      Families and medical teams must often decide on the appropriate level of care for patients~     with severe TBI and frequently need to consider withdrawal of life support measures. These~     decisions have implications for patients with severe TBI, costs to the health care system,~     and rates of organ donation.~      A reliable method for neurological evaluation at the time of the patient's arrival to the~     hospital is important, because it is possible that many patients with severe TBI already have~     permanent brain damage. Assessing this brain damage with clinical tests is difficult because~     of the nature of patients' injuries and the sedative medication they receive at the time of~     their hospital admission. Current standard imaging technique for these patients is severely~     limited in the assessment of the extent and severity of the brain damage.~      Advanced diagnostic imaging, called Computed Tomography Perfusion (CTP), can help detect~     permanent brain damage. However, CTP of the head is not currently done for patients with~     severe TBI when they arrive at the hospital. The investigators want to test whether CTP of~     the head can detect permanent brain damage among patients with severe TBI.~   "
61908|NCT02756572|"~     This clinical trial studies how well early stem cell transplantation works in treating~     patients with high-grade myeloid neoplasms that has come back after a period of improvement~     or does not respond to treatment. Drugs used in chemotherapy, such as filgrastim, cladribine,~     cytarabine and mitoxantrone hydrochloride, work in different ways to stop the growth of~     cancer cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Giving chemotherapy before a donor peripheral blood cell transplant~     helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem~     cells) and cancer cells. When the healthy stem cells from a donor are infused into the~     patient they may help the patient's bone marrow make stem cells, red blood cells, white blood~     cells, and platelets. The donated stem cells may also replace the patient's immune cells and~     help destroy any remaining cancer cells. Early stem cell transplantation may result in more~     successful treatment for patients with high-grade myeloid neoplasms.~   "
61909|NCT02756559|"~     Sepsis is a systemic inflammatory reaction caused by infection, trauma, etc. In the process~     of sepsis, the apoptosis of lymphocyte serves as a vital factor of immune dysfunction.~     Micro-RNAs (miRNAs) are endogenous small non-coding RNA molecules. Our previous studies have~     showed the diagnostic and prognostic value of a series circulant miRNAs in human serum in~     sepsis. The present research further study the regulatory mechanism of those miRNAs in~     lymphocyte in sepsis. Our research is based on the clinical value of miR-223, miR-15a,~     miR-16. The investigators discuss the potential role of miR-223, miR-15a, miR-16 in~     regulating the proliferation and apoptosis of lymphocyte in sepsis and aim to find new~     targets for sepsis treatment.~   "
61910|NCT02756546|"~     This study aims to identify the expression signature of miR-181a, miR-196a and miR-21 in~     plasma of SLE patients and difference in their expression among groups with different~     systemic lupus erythematosis disease activity index (SLEDAI) scores.~   "
61932|NCT02756247|"~     The purpose of this study is to find out if the combination of buparlisib and ibrutinib will~     lead to better treatment results in patients with relapsed or refractory Follicular lymphoma,~     (FL) Mantle cell lymphoma (MCL) or Diffuse Large B-cell lymphoma (DLBCL). The investigators~     are using buparlisib and ibrutinib because both drugs seem to block different proteins that~     allow cancer cells to keep growing. Blocking these proteins may help by making the cancer~     cells undergo cell death, which will stop uncontrolled tumor growth.~   "
61933|NCT02756234|"~     The objective of this study is to carefully monitor all patients undergoing Computed~     Tomographic Perfusion (CTP) at Lancaster General Hospital for safety, and determine the~     efficiency of the CTP procedure in a community setting.~   "
61911|NCT02756533|"~     COPD is characterized by non-reversible chronic airway obstruction. Its evolution is~     punctuated by successive exacerbations precipitating the progression of the disease and its~     co-morbidities. The most severe exacerbations are the source of frequent hospitalizations~     that strongly affect the patient's quality of life and are associated with increased~     mortality. The diagnosis of exacerbation is mainly clinical but patients frequently consult~     their doctor too late which may lead to delays in care. However, the early detection and~     management of these exacerbations can reduce their impact and in particular avoid~     hospitalization or shorten their duration.~      In France, long term Non-Invasive Ventilation (NIV) is a widely used treatment modality in~     COPD patients with chronic alveolar hypoventilation who have frequent exacerbations. The~     investigators have demonstrated in a previous study that the analysis of parameters from~     software embedded in the NIV device can reliably predict the occurrence of an exacerbation.~     The investigators hypothesize that the daily transmission via a telemonitoring platform of~     the ventilation parameters of patients, together with an ad hoc warning system, would reduce~     the rate of hospitalization for COPD patients treated at home with NIV thanks to the early~     detection and early treatment of these exacerbations.~      The purpose of the study is to compare if a program of telemonitoring using the parameters~     stored by the NIV impact the rate of hospitalization for worsening of cardiorespiratory~     symptoms in COPD patients versus standard care over a one year period.~   "
61912|NCT02756520|"~     The purpose of this study is to characterize the patient and disease profile under the~     influence of a protein-restricted diet supplemented with keto acids/amino acids (KA/AA),~     focusing on the progression of chronic renal insufficiency, calcium and phosphorus~     metabolism, nutritional status, patient compliance to diet and Ketosteril intake as well as~     the persistent dietary education to ensure compliance in a large group of pre-dialysis~     patients.~   "
61913|NCT02756507|"~     Anxiety and depressive disorders are common in adolescents, however they are often~     unrecognized. Rational emotive behavioral therapy (REBT), a form of cognitive behavioral~     therapy (CBT) is efficient for children and adolescents. School settings are appropriate~     environments to deliver such interventions for vulnerable youths. Given youth's access and~     predilection to use technology, a video-based prevention program was developed. The present~     study aims to investigate the efficacy of a transdiagnostic REBT prevention program for~     internalizing symptoms in adolescents, implemented in a school setting.~      Classes from different Romanian public schools will be randomized in either intervention or~     wait list group.~   "
61914|NCT02756494|"~     Stroke is the fifth leading cause of death in the United States and the leading cause of~     disability. However, in China, stroke is one of the most frequent causes of death and chronic~     disability. Ischemic strokes in adults younger than 45 years of age were regarded as a~     relatively uncommon event in the proportion of <5% of all ischemic strokes.~   "
61915|NCT02756481|"~     To characterize treatment patterns and healthcare resource utilization among adults diagnosed~     with non-valvular atrial fibrillation (NVAF) from the private setting in Venezuela.~   "
61916|NCT02756468|"~     Background. Pancreatic cancer surgery is associated with very high risk of postoperative~     morbidity and mortality. Anastomotic leak (AL) is one of the worst complications associated~     with relevant short and long-term sequelae. Procalcitonin (PCT) is a biomarker used to~     monitor bacterial infections and guide antibiotic therapy and has been shown to have better~     predictive value of AL after colorectal surgery than C-reactive protein (CRP) and white blood~     cell count (WBC).~      Purpose. The investigators designed a monocentric pilot study to test if PCT might be a~     sensitive and reliable marker of AL after pancreatic surgery~   "
61917|NCT02756455|"~     Background. Gastric cancer surgery is associated with high risk for postoperative morbidity~     and mortality. Anastomotic leak (AL) is one of the worst complications associated with~     relevant short and long-term sequelae. Procalcitonin (PCT) is a biomarker used to monitor~     bacterial infections and guide antibiotic therapy and has been shown to have better~     predictive value of AL after colorectal surgery than C-reactive protein (CRP) and white blood~     cell count (WBC).~      Purpose. Investigators designed a monocentric pilot study to test if PCT might be a sensitive~     and reliable marker of AL after gastric surgery~   "
61918|NCT02756442|"~     Introduction:~      The pregnancy brings about physiological and hormonal modifications which cause sleep~     disorder. The sleeplessness, snoring and a bad sleepquality are frequent during the~     pregnancy. Also a limited breathing airflow happens very often during the pregnancy. The~     limited airflow causes micro-awakenings that enter in the frame of the high resistances~     airways syndrome. To our knowledge there is no study about the outcome of micro-awakenings at~     pregnant women.~      Objectives:~      To compare the prevalence of the high resistances airways syndrome (RERA) in pregnant woman~     with or without gestational diabetes~      Methods :~      It is a monocentrical prospective study at pregnant women after the 30th amenorrhea week who~     consul the gynecologie and obstetrics department of the CHU NORD in Marseille. We are going~     to compare the breathing disorder during sleep of a control group with a group of women with~     gestational diabetes. A polysomnograph will be run at the included patients' home.~      Expected results :~      The physiological and hormonal modifications during the pregnancy could favor nocturnal sleep~     events (snoring, SAHOS and RERA) and its complications as gravidic HPN And gestational~     diabetes cause maternal and fœtal and morbidity and mortality. We put the hypothesis that~     limited airflow in association with micro-awakenings in the RERA have a negative impact on~     the glucose metabolism and favor the gestational diabetes.~   "
61934|NCT02756221|"~     The study will evaluate the change in gastrointestinal (GI) flora following probiotic~     supplementation, and expected to lead to an increase in the intestinal epithelial integrity~     and to improvement in its health. Concurrently with the reduction in the amount of toxins in~     the GI tract following an intensive exercise, a lower incidence of symptoms of discomfort~     will improve the quality of the training sessions which will be exhibited by an improvement~     in endurance capacity and in physiological responses to rigorous exercise. Half of the~     participants will receive probiotic supplement while the other half will receive a placebo.~   "
61935|NCT02756208|"~     This study is designed to evaluate the safety of the FLSC vaccine and will be a randomized,~     placebo-controlled, modified double-blinded dose escalation study in 60 healthy adult~     volunteers (Human Immunodeficiency Virus-1 uninfected).~   "
73294|NCT02607592|"~     The purpose of this study is to investigate the overall toxicity value（OTV）, PFS, ORR and OS~     on advanced adenocarcinoma treated with nadaplatin or cisplatin combined with pemetrexed.~   "
61919|NCT02756429|"~     Atrial fibrillation (AF) is the most common cardiac arrhythmia. Because of its major impact~     on the general morbidity and risk of stroke, AF is a great concern for public health. Several~     mechanisms, including endothelial dysfunction and inflammatory processes, have been~     postulated as predisposing factors for AF, as well as for stroke.~      Both clinical and experimental studies highlight inflammation as a predisposing factor for AF~     and its complications. Nevertheless, the source of high inflammatory proteins in patients~     with AF is still unknown. We hypothesized that multilevel intracardiac and extracardiac (left~     femoral vein, coronary sinus, left atrium, pulmonary vein) measurements of several~     inflammatory proteins (VEGF) would help assessing the extent and the source of inflammation~     in AF patients.~      The measurement of von Willebrand factor (vWF) levels in multiple vascular sites would also~     help to define the site of endothelial dysfunction and of production of this thrombogenic~     factor.~      Although AF is associated with an increased risk of stroke, the risk is not homogeneous.~     Permanent and persistent AF are associated with similar thromboembolic risk to that of~     paroxysmal AF.~   "
61920|NCT02756416|"~     This study aims to quantify perfusion, assess arterial vasoconstriction, and confirm~     reversibility using 3T ASL-MRI and MRA in 10 patients with suspected RCVS. Acquiring these~     data at multiple time points during RCVS progression, the investigators will assess the~     relationship between vasoconstriction and downstream perfusion and determine the role of~     these imaging techniques in early and accurate diagnosis of RCVS. The investigators also aim~     to investigate whether early imaging abnormalities can predict RCVS complications and~     clinical outcomes.~   "
61921|NCT02756403|"~     This study, a double blinded randomized controlled trial, is being done to compare side~     effects of commonly used antibiotic regimens prior to same day abortion procedures.~      In total, 180 pregnant women in their first trimester of pregnancy (5 0/6-13 6/7 weeks~     gestation) will be randomized to receive one of the three commonly used antibiotics~     (azithromycin, doxycycline, metronidazole) for same day abortion procedures or placebo prior~     to their abortion procedure. Approximately, 30-60 mins after study drug administration, the~     procedure will be performed.~      A sub-study will be completed on 40 women who consent to endometrial sampling and to have~     their blood drawn.~   "
61922|NCT02756390|"~     This research study is evaluating the effectiveness of a 3-session behavioral intervention~     for insomnia in cancer survivors. This is a behavioral intervention study, and no medications~     are involved.~   "
61923|NCT02756377|"~     Aim: clinical effectiveness of 0.05% cetylpyridinium chloride mouth rinse in patients with~     gingivitis as compared to non-alcoholic chlorhexidine mouth wash.~      Methods & Material: Twenty-four subjects, without systemic diseases, with plaque-induced~     gingivitis will be selected for this study. The patients were treated with scaling and root~     planing at the baseline; Oral hygiene instructions were given that included brushing twice-~     daily, The volunteers brushed their teeth with the Bass brushing technique for at least 2~     minutes, these patients were randomly ,equally divided into two groups, Group A: perform~     daily mouthwashes twice a day with the solution containing 10 ml of 0.05 cetyl pyridinium,~     (Vi-one, Rojin, Cosmetic-Lab, Kurdistan -Iran), Group B: use daily mouthwashes twice a day~     with 10ml of the chlorhexidine(Kin Laboratories, Spain), On day 0,7,15 and day 21 of each~     phase the Plaque Index (PI), Pocket depth(PD), Stain Index(SI) and Bleeding Index (BI) of~     each volunteer were measured.~   "
61924|NCT02756364|"~     The primary purpose of this study is to compare the progression free survival (PFS) of~     participants treated with the combination of fulvestrant plus daily MLN0128 and fulvestrant~     plus weekly MLN0128 versus participants treated with single-agent fulvestrant.~   "
61925|NCT02756351|"~     The study is a first step in establishing the safety and efficacy of the CytaCoat technology~     when applied to a medical device such as a nasal prong and the clinical data generated will~     serve as a basis for continuous studies in clinically significant settings such as the~     neonatal care units.~   "
61926|NCT02756338|"~     The purpose of this study is to evaluate the safety and feasibility of performing the~     BioMonitor 2 insertion procedure in an office setting.~   "
61927|NCT02756325|"~     Infertility-the inability to conceive despite one year of properly timed unprotected~     intercourse-is a common problem. Of all types of male factor infertility, non-obstructive~     azoospermia may be the most difficult for couples. Importantly, patients with non-obstructive~     azoospermia are asked to make difficult decisions in terms of reproductive choice; surgical~     attempts at identifying sperm (microdissection testicular sperm extraction) are often offered~     to these patients without a guarantee of being able to identify sperm. New methodologies in~     terms of evaluation of azoospermic males PRIOR to the couple embarking upon IVF are needed~     urgently. The other potential benefit of non-invasive determination of testis function and~     spermatogenesis would be the potential targeting of sperm extraction procedures. We~     hypothesize that quantitative MRI employing advanced functional metrics will be sensitive to~     functional and metabolic differences between subsets of azoospermic cases and will improve~     upon current characterization of patients with this condition. Moreover, it is believed that~     these techniques will provide complementary information, such that they may be combined in a~     synergistic fashion for targeted extraction methodologies.~   "
61928|NCT02756312|"~     Although bench data and retrospective studies have provided a promising picture of the~     possible influence of anesthetic technique on the risk of tumor progression, current evidence~     from RCTs is inadequate to show whether the type of anesthetics might influence tumor~     progression.There are many thousands of patients with a cancer diagnosis undergoing surgery~     every year, and in the context of biological plausibility, it should lead to the urgent~     undertaking of RCTs to further evaluate the association between the anesthetic management and~     postoperative malignant glioma progression.~   "
61929|NCT02756299|"~     Obstructive sleep apnea (OSA) is a common disorder with serious complications. Positive~     airway pressure (PAP) is the first line treatment of OSA, which eliminates obstructive~     events, reduces daytime sleepiness, and improves quality of life, especially in those with~     excessive daytime sleepiness. However, despite the benefits of the PAP treatment, overall~     acceptance and adherence rates are not fully promising. Less is known regarding the PAP~     adherence rates in Turkey. In the current study, the researchers primarily addressed if an~     intensified patient education strategy including the polysomnography (PSG) charts viewing~     followed by frequent follow-ups would improve the compliance rates at long-term in patients~     with OSA.~   "
61936|NCT02756195|"~     The study objective is to decrease neonatal mortality and morbidity by elucidating the~     etiology of system failures during perioperative care.~      In Aim 1 the investigators will use a novel event discovery method, based on the construct of~     the nonroutine event (NRE), to efficiently capture dysfunctional clinical microsystem~     attributes and potentially dangerous conditions. A NRE is defined as any event that is~     perceived by care providers or skilled observers as a deviation from optimal care based on~     the clinical situation.~      In Aim 2, the investigators will perform a comparative analysis of prospectively collected~     NRE data to the data collected by conventional event reporting methodologies.~      In Aim 3 the investigators will collaborate with Primary Children's Hospital (PCH) in Salt~     Lake City, UT to conduct practical pilot testing of tools and measures developed and refined~     in the first two Aims.~      Products from Aims 1 & 2 will include:~        1. a taxonomy of NREs and outcomes for perioperative neonates;~        2. neonatal Comprehensive Open-Ended Non-routine Event Survey (NCONES) data collection~          tool;~        3. comparisons of 5 established event reporting systems, including their rates, costs and~          benefits; and~        4. a guide to prototype neonatal safety surveillance and risk prediction for hospitals and~          NICUs.~      Aim 3 will capitalize on PCH's robust network of NICUs, neonatologists, and patient-level~     outcome data to conduct a pilot implementation evaluation of the methods and tools developed~     and refined in Aims 1-2.~   "
61937|NCT02756182|"~     A comparative study will be conducted and the patient will undergo a conventional urodynamic~     study. In order to successfully determine if the Air-Charged (AC) and Water-Perfused (WP)~     measurements are equivalent, the two sources of intravesical pressure (Pves) and abdominal~     pressure (Pabd) will be collected concurrently in the sitting position and at various fill~     volumes for the bladder.~   "
61938|NCT02756169|"~     Investigators propose this study in order to answer the following research question: An~     educational intervention and breastfeeding support at postpartum will increase the frequency~     and total breastfeeding duration in the intervention group? This is a randomized (with~     control and intervention groups) study, open and parallel (1: 1 ratio between study groups)~     with 200 pregnant women in the second or third trimester, according to their body mass index~     (BMI, kg / m2) with excess weight (BMI> 29 pre-pregnancy weight) and that will address their~     pregnancy in the public health services and hospitals belonging to the Health Ministry of 5~     districts: Coyoacán, Magdalena Contreras, Tlalpan, Xochimilco and Alvaro Obregón in Mexico~     City.~      The intervention group and the control group will have the same characteristics for~     eligibility.~      The main phases to develop the study are PHASE 1. INTERVENTION DESIGN PHASE 2. IMPLEMENTATION~     OF THE INTERVENTION. PHASE 3. FOLLOW-UP The intervention will be offered at 3 times: 1)~     Educational intervention (a workshop) to pregnant obese women. The workshop will be held by~     an International Board Certified Lactation Consultant (IBCLC) to promote exclusive~     breastfeeding and to encourage a better breastfeeding performance in accordance with the WHO~     recommendations. The workshop will be held at convenient times and will be conducted for~     groups of 8 to 10 participants; 2) Immediate breastfeeding support at hospital by an IBCLC~     and; 3) The women will be exposed to early telephonic follow-up during the first week of~     their children´s life and each month until six months of life. Then, if the breastfeeding~     continues, each two months until the first year of their children´s life.~      At the first month postpartum, investigators will visit participants at home, both the~     control group and the intervention group, for collecting information on breastfeeding~     practices, for taking a breast milk sample to estimate its fatty acids content, and a blood~     sample (serum) to obtain the C-Reactive Protein. Also, the investigators will take~     anthropometric measurements of the children to evaluate their growth (weight, length, and~     skinfold thickness). Investigators will ask for breastfeeding practices and diet of the~     participants through a 24 hours recall.~      The results of this intervention group will be compared with the control group: pregnant~     obese women without the educational intervention or telephonic follow-up.~   "
61939|NCT02756156|"~     Combining interscalene block with infraclavicular block for humerus surgery provides a unique~     surgical anaesthesia and postoperative analgesia.~   "
61940|NCT02756143|"~     Effect of Physical Exercise Program on fetoplacental circulation and perinatal outcome.~   "
61941|NCT02756130|"~     This phase I/II trial studies how well birinapant and carboplatin work in treating patients~     with ovarian, fallopian tube, or primary peritoneal cancer that has come back. Drugs used in~     chemotherapy, such as birinapant and carboplatin work in different ways to stop the growth of~     tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them~     from spreading.~   "
61942|NCT02756117|"~     This study aims to assess the effect and breakdown of lysine administration, specifically~     examining whether it leads to increased plasma 2-AAA in healthy humans.~   "
61943|NCT02756104|"~     ALS is a devastative disorder characterized by motor neuron degeneration. Median survival is~     3 years after onset, but may vary from a few months to more than 30 years. Various factors~     have been suspected to play a role in such a variation, but recently, it has been described~     that regulatory T-lymphocytes (T regs) may mediate ALS progression and survival. Vitamin D is~     an hormone know to regulated T reg function in vivo and in vitro. It have recently~     demonstrated that vitamin D (VD) levels correlated with ALS prognosis. The investigator want~     to go further in the study of the immune processes that could modulate prognosis in ALS. This~     could allow proposing VD as a potential treatment of ALS in a future trial. More largely,~     this could reinforce arguments in favor of an immune intervention to attenuate the severity~     of this devastating disorder.~   "
61944|NCT02756091|"~     Cervicocerebral artery dissection is a major cause for stroke in young adults. While~     knowledge of cervical artery dissection (CeAD) has increased thanks to a number of high~     quality studies, knowledge on intracranial artery dissection (IAD) is limited. Due to~     treatment and publication bias little is known about the natural history of IAD. Overall, IAD~     is assumed to have a more severe course than CeAD, with a more ominous outcome in patients~     with subarachnoid hemorrhage (SAH). Furthermore, little information is available on the risk~     of recurrent IAD as well as on the risk of recurrent ischemic and haemorrhagic events in~     non-Asian patients. Radiological diagnosis of IAD can be challenging given the small size of~     intracranial arteries, and the subtle and non-specific radiological signs which tend to~     evolve over time. The optimal treatment of IAD is unknown. There are no randomised trials and~     only observational studies with relatively small sample sizes are available, thus providing a~     very low level of evidence.~      Finding the factors that are decisive for outcome and recurrence after intracranial artery~     dissection is key to an improved management of this potentially severe disease predominantly~     affecting young patients. By using standardised protocols for diagnosis, imaging and~     follow-up, the investigators intend to obtain large representative patient samples in order~     to fill the gap of evidence.~   "
61945|NCT02756078|"~     This is a randomized, double-masked dispensing study where subjects will randomized into one~     of two lens sequences to wear each of two contact lens types for a 4-week period with each~     lens type.~   "
61946|NCT02756065|"~     Washington University Early Recognition Center is conducting a research study to examine~     brain functional connectivity and network patterns in participants with bipolar disorder and~     schizophrenia.~   "
61947|NCT02756052|"~     Recent changes in medical training environments and restrictive work-hour regulations have~     greatly impacted trainees, limiting the number of opportunities to gain proficiency in~     procedural skills. Reports suggest that medical residents lack confidence in their ability to~     perform certain medical procedures, and program directors often do not believe their~     residents can operate independently in major procedures. Simulator based task training (SBTT)~     has provided a safe and ethically appropriate method of skill acquisition but training~     opportunities remain limited. Methods to enhance motor learning during these training~     opportunities have not been described. Transcranial direct-current stimulation (tDCS) is an~     emerging form of non-invasive brain stimulation that has been shown to improve motor~     learning. tDCS has been shown to enhance increasingly complex skill acquisition. The~     investigators propose to examine if tDCS can improve the acquisition and retention of~     laparoscopic surgical skill. The investigators propose a double blind, sham-controlled~     randomized trial applying tDCS during evidence-based SBTT of medical students and surgical~     residents, to determine if brain stimulation can enhance training effects and long-term skill~     acquisition. Even a modest enhancement carries the potential to transform medicosurgical~     skills training.~   "
61948|NCT02756039|"~     Clinical experience investigation (CEI) is to be conducted to confirm the following to~     characterise safety and efficacy of Tagrisso Tablets in actual clinical use.~        1. Incidence of adverse drug reactions (ADRs) in actual clinical use~        2. Factors which may affect safety and efficacy of the product (especially analysis of the~          incidence and risk factors of interstitial lung disease (ILD) events)~        3. Information of ADRs not expected from Precautions for Use of the package insert in~          Japan~   "
61949|NCT02756026|"~     The purpose of the study is to establish a protocol for collecting representative samples of~     breastmilk (BM) that can be used to assess the effect of maternal micronutrient (MN)~     supplementation on milk MN concentrations. The investigators will determine which~     breastfeeding episode during the 24 hour period best represents the maternal status; and~     within the episode whether fore, mid or hind milk samples be collected in future studies.~   "
61950|NCT02756013|"~     The purpose of this study is to evaluate the side effects and effectiveness of giving~     standard paclitaxel chemotherapy in doses based on actual body surface area in combination~     with standard dosed carboplatin chemotherapy for overweight women.~   "
61951|NCT02756000|"~     The study will compare clinical outcomes between complete revascularization during~     hospitalization for ST elevation myocardial infarction (STEMI) and intervention after 30 days~     and intervention based on outpatient non-invasive ischemia testing in patients with~     multivessel coronary artery disease (MVD) presenting with first ever ST elevation myocardial~     infarction.~   "
61952|NCT02755987|"~     This is an expanded access study with ANG1005 treatment for two individual patients from~     Protocol ANG1005-CLN-03 with WHO Grade III Anaplastic Astrocytoma and WHO Grade III~     Anaplastic Oligodendroglioma and one individual patient from Protocol ANG1005-CLN-04 with~     Recurrent Brain Metastases and Leptomeningeal Carcinomatosis.~   "
61953|NCT02755974|"~     The London COPD exacerbation (EXCEL) cohort builds on an established cohort started in 1995~     and designed to study COPD exacerbations and their impact on health-status and disease~     progression.~   "
61954|NCT02755961|"~     Hyperphosphatemia is an independent risk factor for mortality among dialysis patients. And~     most phosphate in human is derived from the food. The purpose of this study is to evaluate~     the efficacy of nutritional consultation and education on phosphate binder among dialysis~     patients.~   "
61955|NCT02755948|"~     Respiratory viruses including influenza and respiratory syncytial virus (RSV) are among the~     most important causes of severe disease globally, infecting everyone repeatedly throughout~     life. Understanding of how to prevent infection is incomplete but boosting immunity with~     vaccines remains the best strategy. T cells have been shown in animals to be essential for~     clearing respiratory viral infection and are likely to be helpful if stimulated by vaccines.~     However, where these cells originate from and how they develop in the human lung are still~     unclear. The investigators will inoculate volunteers with influenza or RSV to examine the~     relationship between T cells in their blood and lungs and the outcome of infection. By~     tracking these specialised cells, the investigators aim to develop a better understanding of~     how they are generated in order to harness them with future vaccines.~   "
61956|NCT02755935|"~     To evaluate performance outcomes in patients implanted with the Cochlear Nucleus CI532~     electrode array.~   "
61957|NCT02755922|"~     Mandible fractures are a common cause of facial injury in adults. The autologous mesenchymal~     stem cell (AMSC) transplantation, is proposed as an alternative to the conventional graft~     treatment, improving bone neoformation.The objective was to evaluate the effectiveness of~     AMSCs application in mandibular fractures to reduce regeneration time and increase bone~     quality.~   "
61958|NCT02755909|"~     The study aims to investigate the effect of pre-anesthetic education on patients undergoing~     cardiac surgery~   "
61959|NCT02755896|"~     Post meno-pausal women with T1 Breast cancers will be randomized to receive either 600~     centiGray (cGy) X 5 over five consecutive days (arm 1) versus 800 cGy X 3 fractions given~     every other day (arm 2). Patients will complete treatment in one week. All patients will be~     followed a month after the completion of treatment then q6 months for the first year, then~     yearly for the next 10 years.~   "
61960|NCT02755883|"~     This randomized controlled trial will evaluate, among 54 stage early stage lung cancer~     patients, whether a behavioral intervention versus an educational Control group results in~     improved function at 6-months.~   "
61961|NCT02755870|"~     This is a Phase 1, First-Time-In-Humans, randomized, placebo-controlled, double-blind,~     escalating single- and multiple-dose study to evaluate the safety, tolerability, and~     pharmacokinetics of CNM-Au8 in healthy male and female volunteers. There will be 2 phases to~     this study: a single ascending dose (SAD) phase and a multiple ascending dose (MAD) phase.~     The SAD Phase will be conducted first followed by the MAD phase of the study.~   "
61962|NCT02755857|"~     This open-labelled, single arm study is a follow-on from Study MPG010 to compare the relative~     bioavailability of Lozanoc 65 mg Capsules against Lozanoc 50 mg Capsules and Sporanox 100 mg~     Capsules in patients requiring itraconazole anti-fungal prophylaxis.~   "
72448|NCT02618668|"~     The investigators aim to evaluate the effect of Ketamine/Propofol Admixture on hemodynamic~     stability, recovery time ,patient & doctor satisfaction scores during Endoscopic Retrograde~     Cholangiopancreatography.~   "
61963|NCT02755844|"~     Endometrial cancer ranks 11th in terms of incidence (7275 / year) and mortality (2025 deaths/~     year). The 5-year overall survivals of patients at diagnosis with locally advanced and~     metastatic carcinomas are about 50% and 15% respectively. Beyond first line treatment with~     platinum-based chemotherapy, there is lack of effective drug in this disease, which explains~     the poor prognosis of patients.~      The prognosis of metastatic endometrial cancer patients is poor, and few drugs have been~     shown to be effective beyond first chemotherapy line.~      Endometrial carcinomas are characterized by frequent alterations of PI3K-AKT-mTor; IGF1R and~     of DNA repair pathways. Phosphatase and tensin homologue (PTEN)-phosphoinositide 3-kinase~     (PI3K)-mammalian target of rapamycin (mTor) and DNA repair pathways interact, and inhibition~     of PI3K-AKT-mTor signaling pathway may alter DNA damage repair.~      Metronomic cyclophosphamide regimen may increase the anti-proliferative effects of olaparib~     because it is an alkylating agent, and it exerts anti-angiogenic effects, with a favorable~     toxicity profile.~      Metformin may increase the anti-proliferative effects of olaparib because it downregulates~     IGF1R and PI3K-AKT-mTor pathways, with no additive toxicity.~   "
61964|NCT02755831|"~     Prospective, randomized controlled trial. Pregnant women in early pregnancy will be~     randomized to either the Sleep Study + CPAP group (n = 180) or to a Standard Prenatal Care~     group (n = 180). Subjects in the Sleep Study + CPAP group will complete a sleep study~     (WatchPAT-200, Itamar Medical, Inc.) and have CPAP initiated if the AHI ≥5 as indicated, in~     early and late pregnancy, whereas the other group will receive standard prenatal care. All~     subjects will complete a sleep study again at 12 weeks postpartum.~   "
61965|NCT02755818|"~     Approximately 20 million people in the United States have some form of kidney failure. People~     with kidney failure have an increased chance of having low levels of high density lipid~     (HDL), so called good cholesterol. Patients who are overweight or obese also have low~     levels of HDL. The investigators are trying to find out whether causes of low HDL are the~     same in people who are overweight and in patients with kidney failure so that in the future~     doctors can better treat low HDL cholesterol levels. People with low levels of HDL are more~     likely to have heart attacks and strokes and are more likely to lose kidney function. This~     study hope to learn more about how kidney failure causes low HDL cholesterol levels.~   "
61966|NCT02755805|"~     Cognitive impairments occur frequently after stroke, and are associated with significant~     long-term activities of daily living (ADL) disability and poor quality of life. This research~     study will undertake an innovative approach addressing cognitive impairments, by examining a~     new patient-centered functionally-relevant rehabilitation intervention that teaches~     individuals with cognitive impairments to manage their deficits to reduce ADL disability.~   "
61967|NCT02755792|"~     This study is aimed to investigate the efficacy of an 12-week Chinese calligraphy training~     program for enhancing cognitive and emotional functions of older adults with mild cognitive~     impairment. Participants are tested with several cognitive tests and electroencephalography~     (EEG), psycho-physical parameters and brain activities are recorded. Results are compared at~     pre-intervention, post-intervention, and 6-month post-intervention to provide evidence of~     benefits of Chinese calligraphy practice.~   "
61968|NCT02755779|"~     Although Computed tomography (CT) is not routinely used to evaluate beast masses, It is~     common to discover Incidental breast lesions on chest CT.~      The goal of this study is to investigate the incidence and appearance of incidentally~     discovered breast masses on chest CT.~   "
61969|NCT02755766|"~     While studies have shown that better outcomes are associated with brace wear compliance in~     the scoliosis and clubfoot populations, compliance rates are still poor. Reasons identified~     by patients, parents and research for not complying with prescribed brace wear include the~     inconvenience or irritability of the child when in the brace in the case of clubfeet, and~     fear of looking different from peers, clothes not fitting properly, or discomfort in the case~     of scoliosis. While reasons for noncompliance are many and can be complex, there has been~     some research to indicate that personality traits may play a role in brace wear compliance.~      The primary purpose of the proposed study is to determine if personality traits are related~     to compliance patterns for individuals undergoing brace treatment for AIS or Clubfeet.~   "
61970|NCT02755753|"~     The purpose of this study is to evaluate whether Rebamipide facilitate the healing of~     inflamed mucosa as an adjuvant regimen in erosive reflux esophagitis (ERE).~   "
61971|NCT02755740|"~     This project aims to promote quitting, and reduction for those who do not want to quit, among~     female smokers through training female youth as smoking cessation and reduction ambassadors~     (SCRA). The objectives are to:~        1. Promote age and gender-specific smoking cessation and reduction to the female population~        2. Deliver a smoking cessation and reduction ambassador training workshop to equip and~          empower female youth with the knowledge on the adverse effects of smoking on female~          smokers and the skills in smoking cessation and reduction and in raising public~          awareness of the harmful effects of smoking on female smokers.~        3. Have the trained female youth to deliver a brief advice (AWARD) to female smokers to~          help them to quit or reduce smoking and refer them to the female-specific smoking~          cessation hotline or the Department of Health Quitline for further assistance if needed.~   "
61972|NCT02755727|"~     Chronic Lateral Epicondylar Tendinopathy is a debilitating condition that is associated with~     repetitive use of the forearm extensor muscles. Though often self-limiting in nature there~     are a proportion of patients who fail to respond to conservative treatments such as rest,~     activity modification, physiotherapy and the use of a brace. Though previously a common~     treatment modality steroid injections have been shown to be detrimental in the longer term.~     Present practice is to offer those patients who do not respond to conservative treatment~     surgical debridement. Though often effective this is an invasive procedure. Platelet rich~     plasma injections may offer a viable alternative in chronic cases however there is no~     systematic evidence of its efficacy.~      Methods 12 patients, diagnosed with chronic lateral epicondylar tendinopathy, will be~     randomly assigned to receive either open surgical debridement or platelet rich plasma~     injections. Following treatment, they will be followed up at intervals of 6 weeks and 3, 6~     and 12 months. The outcome of each treatment will be assessed using validated outcome scoring~     measures specifically designed for upper limb pathology. The results of this pilot study will~     be used to construct a larger randomised control trial.~   "
61973|NCT02755714|"~     Exercise Induced Laryngeal Obstruction (EILO) is a condition not uncommon in otherwise~     healthy young people. EILO is caused by posteromedial collapse of supraglottic structures or~     medialization of the vocal folds, or both, during high intensity exercise. There are~     currently no treatments available that is properly evidence based. However, case reports~     suggest a possible effect from the asthma drug Ipratropium Bromide (Atrovent®). The current~     project is an open label pilot study, aiming to test if Atrovent can influence the occurence~     of EILO, either postponing the onset during exercise or fully prevent the condition to occur.~   "
61974|NCT02755701|"~     To compare the efficacy of branched-chain amino acid in serum albumin level in cirrhotic~     patients with ascites.~   "
61975|NCT02755688|"~     Atrial fibrillation (AF) is the most common heart arrhythmia. Many people do not have~     symptoms and are not aware they have AF. Others may feel dizzy, short of breath, feel very~     tired and become aware of a fast and irregular heart beat (palpitations). The main~     complication of AF is an increased risk of stroke and incidence of heart failure. There are~     two key aspects of treatment for AF. The first is protection from stroke, treated with oral~     anticoagulants. Treatment of AF is either by controlling the rate (frequency of contraction)~     or controlling the rhythm (restoring regular contraction). Rate-control is generally employed~     first with an intent to reduce the rate at which the lower pumping chambers contract and~     improve their efficiency. Appropriate medication is used and with this treatment strategy it~     is accepted that AF will be present as the long term heart rhythm. If symptoms persist~     despite medication the preferred strategy is to restore sinus rhythm (SR) and regular~     contraction in all pumping chambers of the heart. This can be done with electric shock~     treatment (DC cardioversion) together with long-term tablet medication, or by a more~     definitive 'cauterisation' therapy (catheter or thoracoscopic surgical ablation). In this~     study the investigators will study patients with symptomatic long standing persistent AF~     (continuous AF for more than 1 year) who have tried and failed drug and/or electrical~     therapy. At present the investigators do not know what the best ablation technique is for~     treating symptomatic, long-standing persistent AF (LSPAF). Catheter ablation (CA) is the most~     widely available invasive treatment available for AF. Thorocoscopic surgical ablation (SA) is~     not widely available but our hospitals have the expertise to conduct this procedure. CA has~     been shown to achieve modest degrees of success in restoring normal SR with the caveat that~     most patients do require 'multiple' procedures (usually two or three). SA offers patients an~     alternative choice of therapy with a keyhole surgical thoracoscopic) approach. It may have a~     higher single procedure success rate although there is the potential for greater complication~     rates. The investigators aim to examine this in detail to help us understand which approach~     might be better for managing LSPAF.~   "
61976|NCT02755675|"~     uPAR PET/CT as a prognostic marker in non-small cell lung cancer.~   "
61977|NCT02755662|"~     ESTAMPS is a randomized clinical trial with a crossover design:~      Main objective is to compare impact of 2 different Mandibular Retention Device (MRD) designs~     (Narval MRD CadCam (CC) design vs Narval MRD traditional (trad) design) on upper airway~     volume~      secondary objectives: To evaluate the maximal mandibular propulsion according to the type of~     MRD To evaluate benefits on quality of life, sleepiness and OSA symptoms To evaluate impact~     of MRD design on therapy efficacy and tolerance To evaluate impact of MRD design on~     mandibular positioning~   "
61978|NCT02755649|"~     The main objective of the trial is to evaluate the efficacy of 2 dose regimens of dupilumab~     compared to placebo, administered with concomitant topical corticosteroids (TCS), in adult~     patients with severe AD who are not adequately controlled with, or are intolerant to, oral~     Cyclosporine A (CSA), or when this treatment is currently not medically advisable.~      The secondary objective is to assess the safety and tolerability of 2 dose regimens of~     dupilumab compared to placebo, administered with concomitant TCS, in adult patients with~     severe AD who are not adequately controlled with, or are intolerant to, oral CSA, or when~     this treatment is currently not medically advisable.~   "
61979|NCT02755636|"~     Patients with co-occurring health risk behaviors suffer greater morbidity, disability, and~     premature death. The Pro-Change Population Health Solution (PCPHS) is a suite of mobile tools~     designed to assist patients and primary care providers (PCPs) in applying evidence-based~     principles of health behavior change to reduce four cancer risk behaviors—cigarette smoking,~     risky drinking, noncompliance with national guidelines for physical activity, and overweight~     and obesity—and depression among at-risk patients. The intervention is based on the~     Transtheoretical Model of Behavior Change (TTM, the stage model) and includes~     computer-tailored interventions and text messages for patients and a clinical dashboard for~     providers. The efficacy of the intervention will be assessed in a cluster-randomized trial~     involving 780 patients recruited from 12 federally qualified health centers randomly assigned~     to intervention or usual care.~   "
61980|NCT02755623|"~     The potential of non-invasive Transcranial Magnetic Stimulation (TMS) as a therapeutic tool~     for improving schizophrenic symptoms, in particular resistant hallucinations, has been~     increasingly studied over the past decades. Several studies have demonstrated that~     low-frequency patterns of repetitive TMS (rTMS) applied over the left Temporoparietal~     Junction (TPJ), which are known to decrease local activity, significantly reduced auditory~     verbal hallucinations in schizophrenic patients. In spite of highly promising results, a high~     level of inter-individual variability in the responses to non-invasive brain stimulation~     treatments, and the fact that rTMS may prove ineffective in some patients, keep spurring~     controversy about the efficacy of these approaches (as currently performed), as well as about~     how to increase its efficacy and consistency. Accordingly, the objectives of this project are~     to better understand the impact of rTMS on the brains of patients with resistant auditory~     hallucinations, and to use this information not only to better understand this condition but~     to develop more efficient and consistent therapies. Thus, in this study, the investigators~     focus more specifically on resistant auditory hallucinations in schizophrenia, which is a~     common symptom in schizophrenic patients, and can be treated by rTMS. The investigators~     hypothesize that there is a baseline difference in anatomical and/or functional connectivity~     between responder and non-responder patients who are treated with rTMS. Therefore, our~     project will aim to determine some anatomical and functional connectivity markers of response~     to rTMS treatment in patients with schizophrenia~   "
61981|NCT02755610|"~     Peritoneal Dialysis (PD) has been the main method of treatment for Thai End-Stage Renal~     Disease (ESRD) patients under the PD First policy of the Universal Coverage (UC) scheme.~     The increased demand has resulted in not only supply chain logistical problems, but also~     product quality concerns. Peritonitis, the main complication and main cause of failure in~     Continuous Ambulatory Peritoneal Dialysis (CAPD) patients, could be caused by product defect.~     This cluster randomized trial will be conducted in participating Peritoneal Dialysis Outcomes~     and Practice Patterns Study (PDOPPS) centers in Thailand to assess if a check list~     intervention could reduce peritonitis rate and increase the number of product defect report.~   "
72449|NCT02618655|"~     The study will use several laboratory diagnoses in the diagnosis of patients with fever，to~     find out which will be more helpful for making an accurate diagnosis in the early period of~     Tickborne Diseases.~   "
61983|NCT02755584|"~     Background:~      Cellular senescence is the aging of cells. It is a complex process that may be connected with~     aging and age-related diseases. It is unknown if these cells appear around wound sites in~     humans a few days after skin injury and if there are differences in young and old~     individuals. This study is being done to look at how cells in your body respond to small skin~     wounds. This information may help treat age-related diseases.~      Objective:~      To study how cells in the body respond to small skin wounds.~      Eligibility:~      Healthy adults ages 20-39 or 70+~      Design:~      Participants will be screened with medical history, physical exam, and blood sample. They~     will fast before the screening visit. Women will have a urine pregnancy test.~      Participants will have 3 study visits over about 3 weeks.~      Visits 1 and 2: Participants will fast before and have blood taken. Women will have a urine~     test. All participants will have 2 skin biopsies. A spot on the upper arm will be numbed. Two~     small pieces of skin will be removed. They will keep the area covered until the next visit.~      Visit 3: Participants will have their vital signs taken. Their biopsy wounds will be measured~     and photographed.~   "
61984|NCT02755558|"~     In this study, the investigators varied both the energy density and portion size of milk~     served with a meal commonly consumed by preschool children. The milk used in this study is~     commercially available and reflects typical variations in energy density. The primary aim of~     the study is to investigate the independent and combined effects of milk energy density and~     portion size on preschool children's intake of the milk and the simultaneously served meal.~     The effect of milk energy density and portion size on children's total energy intake at the~     meal will also be evaluated.~   "
61985|NCT02755545|"~     The purpose of this study is to evaluate the efficacy of 2 acne treatments for 24 weeks of~     use in adult men and women with mild to moderate facial acne, at least 5 inflammatory~     lesions, and at least 10 - 100 non-inflammatory lesions.~      Objective:~        1. To characterize the effectiveness of the acne treatment in lesion count at week 1, week~          2, week 6, week 12, and week 24 as compared to baseline and compare between treatments~        2. To characterize the effectiveness of the acne treatment in Investigator's Global~          Improvement Assessment at week 1, week 2, week 6, week 12, and week 24 as compared to~          baseline and compare between treatments~        3. To characterize the effect of the acne treatment in clinical grading of efficacy~          parameters through digital images at week 6, week 12, and week 24 as compared to~          baseline and compare between treatments~        4. To characterize the effect of the acne treatment in subject self-assessment~          questionnaire responses at week 1, week 2, week 6, week 12, and week 24 as compared to~          baseline and compare between treatments~   "
61986|NCT02755532|"~     Introduction: The risk of systemic toxicity when using bupivacaine is a persistent problem,~     making its pharmacokinetic study crucial to the safety of regional anesthesia (RA). Little~     evidence exists regarding the effect of different concentrations of this drug on peak plasma~     levels. The present study compares two bupivacaine concentrations to establish how the~     concentration and exchange area affect the peak plasma level of this drug during axillary~     brachial plexus block. Latency and postoperative analgesia periods were also compared.~      Methods: 32 patients were randomly assigned to two groups. In the 0.25% group, 10 ml of 0.25%~     bupivacaine was injected per nerve; in the 0.5% group, 5 ml of 0.5% bupivacaine was injected~     per nerve. Peripheral blood samples were collected every 15 min during the first hour and~     every 30 min during the second hour to establish serum level dosage. High-performance liquid~     chromatography coupled with mass spectrometry was used for the analysis.~   "
61987|NCT02755519|"~     To optimize the confirmatory tests for primary aldosteronism.~   "
61988|NCT02755506|"~     The study aims to evaluate the role of endobronchial ultrasound elastography in~     differentiated diagnosis of benign and malignant thoracic lesions~   "
61989|NCT02755493|"~     This project proposes to both develop and test adaptive automation countermeasures for the~     effects of stressors such as sleep deprivation (SD) on human performance related to robotic~     tasks, and investigate the relationship between human trust and appropriate use of these~     countermeasures.~   "
61990|NCT02755480|"~     Patients with bone marrow cancer are more susceptible to chest infections than healthy~     adults; marrow ablation treatment further compromises their immune status and increases the~     risk of fungal opportunistic infection, which is associated with a high fatality rate.~     Therefore, it is critical to achieve early and accurate diagnosis of fungal infection when~     these patients become febrile. At the Mount Sinai Hospital (MSH) and the University Health~     Network (UHN), the standard of care (SOC) to exclude a chest infection in immunocompromised~     (IC) patients is chest computed tomography (CT) using low dose CT (LDCTT).~   "
61991|NCT02755467|"~     To evaluate the safety and effectiveness of the laser treatment for the treatment of spider~     angiomas.~   "
61992|NCT02755454|"~     The goal of this study is to determine specific perfusion patterns for radiation induced lung~     changes and residual/recurrent lung malignancies in patients treated with stereotactic body~     radiotherapy SBRT and thus improve to distinguish radiation changes from residual/recurrent~     lung cancers. Currently CT is often unable to make a clear differentiation between benign and~     malignant changes in the lung after SBRT treatment necessitating additional wait time to~     perform follow up CTs or biopsies. Optimal treatment may be delayed. The investigators want~     to apply a CT perfusion sequence in addition to the routine follow up CTs with the goal to~     obtain perfusion values of post treatment lung changes and lung tumours. The investigators'~     hypothesis is that CT perfusion values will help differentiate benign post radiation changes~     from residual/recurrent tumour in the lung with higher confidence and may help avoid~     unnecessary delays in cancer treatment.~   "
61993|NCT02755441|"~     All incident cases of idiopathic pulmonary fibrosis (IPF) in Denmark will be offered~     inclusion during a 2 year period and followed up for at least 1 year with measurements of~     serum biomarkers and measurements of disease progression.~   "
61994|NCT02755428|"~     This project intends to transplant human embryonic stem cells derived retinal pigment~     epitheliums into subretinal space of patients to treat dry age-related macular~     degeneration(dry-AMD).And we will assess the safety and efficacy of RPE transplants to treat~     dry AMD.~   "
61995|NCT02755415|"~     Investigation of the clinical feasibility and efficacy of a newly developed robot-assisted~     gait training system for acute stroke survivors. It is anticipated that robot-assisted gait~     rehabilitation will achieve significantly better gait and quality of life outcomes than the~     standing table rehabilitation.~   "
61996|NCT02755402|"~     Persons who inject drugs (PWID) are overrepresented among hepatitis C infected patients, but~     underrepresented among those who are treated, despite many studies showing that treatment is~     feasible and effective in this population.~      The hepatitis C diagnosis and pre-treatment evaluation are multistep processes. Every step is~     a potential occasion for disengagement and loss to follow-up. This is especially true with~     hard-to-reach populations such as PWID in whom competing needs are numerous and psychosocial~     situation can change rapidly.~      By using new technologies that can quickly provide clinical results, like Xpert HCV Viral~     Load (Cepheid) and transient elastography (fibroscan), a provider could determine if a~     patient needs treatment rapidly or not on the day of the initial visit.~      The aim of this study is to explore whether an accelerated pre-treatment evaluation can~     result in an improved linkage-to-care (defined as linkage to health care, addiction or social~     services) and, eventually, linkage-to-treatment among PWID.~   "
61997|NCT02755389|"~     This is a randomized clinical trial investigating the utility of apneic oxygenation via nasal~     cannulae in the post-induction setting for the purpose of prolonging the safe apneic time.~     Three groups will be compared, a control group at 0 L/min, a 15 L/min and a 60 L/min group.~     The primary outcome will be the difference in the partial pressure of oxygen in arterial~     blood (PaO2) between groups throughout the nine-minute apneic period.~   "
61998|NCT02755376|"~     Purpose:Development of novel strategy for treatment of anterior cruciate ligament (ACL)~     injury using stem cell.~   "
61999|NCT02755363|"~     The purpose of this study is to determine whether the selected osteopathic techniques have a~     positive impact on the residual volume decrease in patients with chronic obstructive~     pulmonary disease with severe and very severe airflow limitation in comparison to the manual~     therapy not aimed to decrease hyperinflation (placebo).~   "
62000|NCT02755350|"~     Daily oral PrEP will be delivered to men who have sex with men (MSM), female sex workers~     (FSWs) and young women (YW) as part of a defined package of HIV combination prevention~     intervention for 12 months in 5 sites in Kenya. The project will assess adherence, adverse~     events, side effects, user satisfaction, cost, facility preparedness and provider~     competencies. PrEP eligibility and screening tools for MSM, YW and FSWs will be piloted and~     validated. Pregnant women will be enrolled in a sub-group and followed through 12 months~     post- partum to measure mother and infant outcomes that include health status, birth~     outcomes, birth defects, risk behavior and PrEP adverse effects. With lessons from initial~     PrEP studies in West and Central Africa, this project will apply good participatory practice~     guidelines through 1) continuous engagement with communities of FSWs, YW and MSM and 2)~     development and use of a communication engagement and advocacy strategy that will provide~     correct information, address attitudes and concerns whilst increasing demand for PrEP uptake.~     The actual cost of delivering HIV combination prevention which includes PrEP will also be~     assessed and cost effectiveness modeled.~   "
62001|NCT02755337|"~     To evaluate Non-Small Cell Lung Cancer (NSCLC) patients clinical profile and the outcome~     after treatment with Gefitinib in Pulmonary Oncology Outpatient Clinic Dr. Soetomo General~     Hospital, Surabaya, Indonesia.~   "
62002|NCT02755324|"~     Groups of 3 or 7 volunteers will be exposed to a predetermined number of male Schistosoma~     mansoni cercariae until 10 volunteers are found infected.~   "
62003|NCT02755311|"~     The role of transarterial chemoembolization (TACE) as the standard therapy for~     intermediate-stage hepatocellular carcinoma (HCC) is being challenged by increasing studies~     which showed that liver resection (LR) is a safe and feasible procedure with better survival~     outcomes than TACE does.~      In light of this, the investigators have constructed a Markov model to simulate comparing LR~     and TACE in the treatment of intermediate-stage HCC. The results suggested that LR may~     provide survival benefit over TACE for the treatment of intermediate-stage HCC in cirrhotic~     patients. However, validating the simulated result by a study with higher quality (e.g.~     prospective clinical trial) would be of great value in providing a more convincing finding.~     Therefore, based on the established Markov model, the investigators aimed to prospectively~     compare the treatment efficacy and safety of LR with TACE for consecutive patients with~     intermediate-stage HCC.~   "
62004|NCT02755298|"~     The study seeks primarily to determine the chronic clinical effect of AZA on exercise~     capacity (6MWD) compared to placebo.~   "
62005|NCT02755272|"~     The main purpose of this study is to see if Pembrolizumab in combination with chemotherapy~     (carboplatin and gemcitabine) is safe and effective in treating patients with metastatic~     triple negative breast cancer.~      Pembrolizumab is a drug which may help the immune system to target and destroy cancer cells.~     Pembrolizumab has been approved by the FDA for the treatment of advanced melanoma and~     metastatic non-small cell lung cancer. However, it has not been approved as a treatment for~     breast cancer.~   "
62006|NCT02755259|"~     To study the acute effect of acetazolamide (AZA) on pulmonary hemodynamics in patients with~     pulmonary hypertension (PH) undergoing clinically indicated right heart catheterisation~     (RHC).~   "
62007|NCT02755246|"~     The overall objective of this study is to examine the effect of polyamine supplementation on~     cognitive performance of individuals with subjective cognitive decline.~   "
62008|NCT02755233|"~     Serial spirometries and measurements of CO-diffusion capacity (DLCO) in patients with MM~     before and during treatment with ipilimumab are performed. A reduction from baseline of~     forced vital capacity (FVC) of ≥10%, or ≥15% of DLCO was defined clinically meaningful, thus~     indicative for pulmonary toxicity.~   "
62009|NCT02755220|"~     This study aimed to evaluate the safety and effectiveness of Cingularbio® heart valve in~     Aortic Valve Replacement and Mitral Valve Replacement in Chinese population~   "
62010|NCT02755207|"~     The purpose of this study is to evaluate the potential diagnostic and prognosis value of~     circulating microRNAs compared with cTnI for suspected ACS patients at the emergency~     department (ED) and intensive care unit (ICU).~   "
62034|NCT02754895|"~     This trial is part of a multi-phase study to develop and test positive psychology (PP)~     interventions in patients hospitalized for an acute coronary syndrome (ACS).Using a factorial~     design, the investigators will: (a) assess the optimal frequency of exercise completion, (b)~     determine the utility of 'booster sessions' after an initial 8-week intervention, and (c)~     determine the relative merits of utilizing PP exercises alone versus an intervention~     combining PP with motivational interviewing (MI).~   "
62011|NCT02755194|"~     Some medications taken by the breastfeeding women are excreted into milk, posing a potential~     risk of toxicity to the infant. The first line of evidence required for toxicity risk~     assessment is prediction of drug levels in milk. However, pharmacokinetic (PK) information of~     drug excretion into milk is largely lacking, or limited to data from case reports. This makes~     it difficult to provide population-level prediction of drug levels in milk. The lack of data~     on this topic jeopardizes not only maternal adherence to drug therapy during breastfeeding~     but also establishment of breastfeeding, even if the drug is considered safe during nursing.~     Clearly, this clinical problem in drug safety is an important women's health issue, affecting~     both mother and infant. Drugs in Lactation Analysis Consortium (DLAC) is a drug-in-milk~     monitoring network, which is designed as a platform for efficient collection of patient milk~     samples in a real world setting to generate population predictions of drug excretion levels~     into human milk.~   "
62012|NCT02755181|"~     This study aims to use resting-state and task based functional Magnetic Resonance Imaging~     (fMRI) as a tool to evaluate trait characteristics of impulsivity in subjects with borderline~     personality disorder.~   "
62013|NCT02755168|"~     Caesarean section is one the most common operations worldwide, its rates are globally~     increasing. A multitude of efforts had been done aiming at reduction of Caesarean section~     related maternal morbidities; most of them are related to technical modifications of how to~     open and how to close the abdominal and uterine incisions . The comparative studies of blunt~     versus sharp extension of the uterine incision showed a reduction of the incidence of~     unintended extension from 8.8% to 4.8% .~      The vulnerability of the lower uterine segment for tears are related to stage of labor. The~     frequency of unintended extension was reported to be 15.5%, and 35.0% in cases operated in~     first and second stages of labor respectively.~      The original techniques of fetal head extraction entail the introduction of the obstetricians~     hand or other instruments into the lower uterine segment . This puts the lower uterine~     segment at risk of damage and incision extensions with its consequences of increased blood~     loss, increased operative time, infection adhesions and blood transfusion. Adherence to the~     available the generated good quality evidence bases practice in Caesarean section is~     anticipated to decease such morbidities.~      The idea of the present technique was derived from the fact that during vaginal delivery the~     main task of obstetrician is to support the perineum while the fetal head extends to get out~     through birth canal.~   "
62014|NCT02755155|"~     Primary purpose : mortality at Day 28~      Secondary purposes :~        -  Daily SOFA (Sequential Organ Failure Assessment) score lessening within Intensive Care~          Unit (ICU)~        -  Duration of increasing doses of norepinephrine infusion to maintain target mean arterial~          pressure~        -  Number of care-related infections within ICU~   "
62015|NCT02755142|"~     This study is planned to detect a dose-efficacy relationship between the chosen dose levels~     of MC506/1 and the extent and quality of fluorescence in the tumour core in patients with~     newly diagnosed malignant glioma.~   "
62016|NCT02755129|"~     The aim of this study is to evaluate sit-stand phases and gait speed detection using an~     externally worn Reveal LINQTM compared to an external reference (3D accelerometer, and/or the~     Computer Assisted Rehabilitation Environment (CAREN) system) in one center in the Netherlands~   "
62017|NCT02755116|"~     Ambulatory surgery is occurring with rapidly increasing frequency as surgical and anesthetic~     techniques have improved and pressure to reduce health-care costs has increased. While there~     are many benefits to recovering from surgery within the home, a significant disadvantage is~     the lack of rapid access to a healthcare provider when postoperative complications occur.~     Postoperative nausea and vomiting (PONV) are common after surgery and anesthesia, and recent~     studies have demonstrated a high incidence of post-discharge nausea and vomiting (PDNV) after~     ambulatory surgery, particularly in high-risk groups (female gender, age less than 50 years,~     history of PONV, opioid administration in the post-anesthesia care unit (PACU), and nausea in~     the PACU). Current practices known to reduce the risk of postoperative nausea and vomiting in~     the PACU, such as the avoidance of volatile anesthetics and the use of intraoperative~     ondansetron and steroids, have little effect on the risk of delayed PDNV. Novel strategies to~     prevent PDNV are needed. Orally administered olanzapine, which has been shown to decrease the~     incidence of chemotherapy-induced nausea and vomiting, demonstrates promise as a novel~     strategy for preventing PDNV. It has a long half-life, allowing for a single dose to be~     administered preoperatively. This study will evaluate whether there is a difference in the~     incidence and severity of PDNV between patients who receive oral olanzapine versus placebo~     prior to general anesthesia for ambulatory surgery.~   "
62018|NCT02755103|"~     The current study will modify an already existing therapy for individuals with substance use~     disorders to address Post Traumatic Stress Disorder (PTSD) in women enrolled in substance use~     disorders (SUD) treatment who suffer with both PTSD and SUD. Mindfulness meditation has been~     shown to help individuals to cope with stress and regulate emotions. Through meditation~     practice women will experience less distress related to PTSD symptoms and reduced substance~     use in response to emotional triggers. Women enrolled in intensive SUD treatment at a~     community program will be randomized to receive either 8 weeks of 90 minute Mindfulness Based~     Relapse Prevention (MBRP) group sessions plus treatment as usual (TAU) or TAU alone. The MBRP~     group sessions will replace 90 minutes of TAU group therapy. Measures of feasibility of~     implementation, acceptance and adherence will be obtained. Preliminary efficacy for substance~     use and PTSD symptom severity will be measured at post treatment and at 3- and 6- months'~     follow-up.~   "
62019|NCT02755090|"~     This study is a multi-site, double-blinded, randomized, non-inferiority clinical trial of~     inhaled nitrous oxide with oxygen (N2O/O2) versus intravenous (IV) sedation, with fentanyl~     and midazolam, for pain management in adult women having a pregnancy termination procedure~     between 12 and 16 weeks gestational age.~   "
62020|NCT02755077|"~     Upper airway obstruction commonly occurs after induction of general anesthesia. The aim of~     this study is to determine if head rotation improves the efficiency of mask ventilation of~     anesthetized apneic adults.~   "
62021|NCT02755064|"~     With this study, the investigators hoped to learn if the rate at which food empties from the~     stomach affects blood sugar values. Using data from this study, we hope to improve our~     ability to control blood sugars in individuals with type 1 diabetes mellitus.~   "
62022|NCT02755051|"~     Children with Autism Spectrum Disorder (ASD) and insomnia, and their parent(s) will undergo 8~     sessions of Cognitive Behavioral Therapy designed for Children with Chronic Insomnia and ASD~     (CBT-CI-A). Treatment delivery will be assessed for each session. Treatment receipt will be~     assessed at the end of session 3. Treatment enactment will be assessed throughout treatment,~     post-treatment, and follow-up. Sleep and secondary outcomes (child daytime behavior, parent~     sleep) will be collected at baseline, post-treatment, and 1-month follow-up.~      Study Flow:~      Baseline (wk1-2) ---> CBT-CI-A (wk3-10) ---> Post-Treatment (wk11-12) --->Wks 13-16~     --->Follow-up (wk 17-18)~      Session:~        1. Sleep education~        2. Sleep scheduling, limit setting, and stimulus control~        3. Teaching relaxation strategies and other adaptive coping skills~        4. Parenting strategies (differential attention, rewards, consequences)~        5. Identification of maladaptive & adaptive cognitions~        6. Problem solving & communication skills~        7. Sleep restriction; bright light to change circadian rhythms~        8. Review gains and plan for long-term maintenance~   "
62023|NCT02755038|"~     The investigators hypothesis is that we can determine estrogen and progesterone levels in the~     hair by using the immune method and we can show a significant difference in the levels of~     these hormones in both groups of women: pre- and postmenopausal women. If indeed it would~     then be possible in future to carry out research that can find a relationship between the~     levels of these hormones and various diseases~   "
62024|NCT02755025|"~     The SOFA score is a severity of illness and prognostic score used in the ICU. It has also~     recently been adopted as part of the definition of sepsis. This study will prospectively~     evaluate the usability of automated SOFA scoring for ICU patients within an electronic~     patient monitoring dashboard. It will also assess for changes in physician ordering (volume~     and types of orders) after automatic scoring is implemented.~   "
62025|NCT02755012|"~     This study takes place in rural Mam-Mayan communities of Guatemala characterized by high~     rates of childhood stunting. It aims to characterize women's exposure to nutrition, infection~     and psychosocial stressors vs. resilience factors, to evaluate the cumulative impact of~     maternal-level factors (nutritional, infectious, psychosocial), social factors (autonomy,~     social support, domestic violence), and household factors (socioeconomic status, food~     security) on early infant growth, and to evaluate whether maternal cortisol may be a mediator~     in the vertical transmission of stress.~   "
62026|NCT02754999|"~     In this open-label study, eligible and consenting adult patients admitted to the hospital for~     critical care that have acute severe anemia, defined as a blood hemoglobin level ≤ 5 g/dL,~     but who are unwilling or unable to receive red blood cell (RBC) transfusion, will receive one~     or more infusions of SANGUINATE as are deemed necessary by the Investigator for survival of~     the acute anemic episode.~   "
62027|NCT02754986|"~     This study assesses autonomic nervous system function by power spectral analysis of RR~     interval dynamics in ultrafiltration subjects without blood pressure variation.~   "
62028|NCT02754973|"~     Background: Despite the evidence that regular physical activity can have beneficial effects~     on the physical and psychological well-being of cancer patients, a review of the literature~     reveals that a majority of young cancer patients fail to attain the same levels of physical~     activity that they had before contracting the disease. There is scientific evidence that~     physical inactivity induces muscle catabolism and atrophy and cardiovascular diseases, which~     may lead to a further increase in fatigue and a decrease in the functional capacity of cancer~     patients. Empirical evidence is needed to explore an appropriate strategy for promoting~     physical activity in such patients.~      Purposes: To examine the effectiveness of an integrated experiential training program with~     coaching by healthcare professionals in promoting regular physical activity, reducing fatigue~     and enhancing quality of life among Hong Kong Chinese childhood cancer patients.~      Design and Subjects: A randomised controlled trial (RCT), two-group pre-test and repeated~     post-test, within and between subjects design will be conducted. Recruitment of subjects will~     be carried out in a paediatric oncology ward of a Hong Kong acute care hospital.~      Intervention: Participants in the experimental group will join an integrated experiential~     training program with coaching by healthcare professionals, which contains 28 home visits by~     a designated nursing student as a coach for a 6-month period. Those in the placebo control~     group will receive an amount of time and attention (home visits by research assistants) that~     mimics that received by the experimental group.~   "
62029|NCT02754960|"~     Background: Repeated bleeding from gastrointestinal vascular malformations remains to be a~     major therapeutic challenge.~      Methods: The investigators performed a randomised, double-blind, placebo-controlled, single~     centre study to assess the long-term efficacy and safety of thalidomide 100mg qn p.o. or~     placebo 100 mg qn p.o. administration for 4 months in subjects with recurrent~     gastrointestinal bleeding due to vascular malformations. Patients with at least six episodes~     of bleeding in the prior year due to vascular malformation were randomly grouped, prescribed~     a four-month regimen of either 100mg of thalidomide or 100 mg of placebo orally one time~     daily, and monitored for at least one year. The primary end point was defined as the patients~     whose rebleeds decreased from baseline by ≥ 50% at 12 months. Rebleeding was defined based on~     a positive fecal occult blood test (FOBT) (monoclonal colloidal gold color technology) at any~     visit after treatment. Secondary outcomes included the changes from baseline in participants~     dependent on blood transfusions and transfused packed red cell units, bleeding episodes,~     bleeding durations, and hemoglobin levels at 12 months. Statistical significance was defined~     at P < 0.05.~   "
62030|NCT02754947|"~     The goal of this study was to identify the etiology of events and demographics of patients~     that experience complications requiring activation of the Rapid Response Team (RRT) during~     the first 24 h following anesthetic care.~   "
62031|NCT02754934|"~     This study evaluates, if the movement of the cervical spine, assessed via a specific~     questionnaire by the patient, is a valid and reliable tool and could be used in daily~     clinical routine.~   "
62032|NCT02754921|"~     The aim of this study is to compare Ultra-perc single stage dilator technique with Ciaglia~     Blue Dolphin ballon dilatation technique for intubated unweanable ICU patients with respect~     to procedure difficulties and complications.~   "
62033|NCT02754908|"~     This study aims to examine the effects of musical training on improving the neurocognitive~     function and psychological well-being of children surviving brain tumours. Half of the~     participants will receive weekly 45-minute lessons on musical training for one year (52~     weeks) while the other half are the placebo controls.~   "
62037|NCT02754856|"~     The goal of this clinical research study is to learn if tremelimumab in combination with~     MEDI4736 can help to control colorectal cancer that has spread to the liver. The safety of~     these drugs will also be studied.~      This is an investigational study. MEDI4736 and tremelimumab are not FDA approved or~     commercially available. They are currently being used for research purposes only.~      The study doctor can explain how the study drugs are designed to work.~      Up to 35 participants will take part in this study. All will be enrolled at MD Anderson.~   "
62038|NCT02754843|"~     The purpose of this study, which contains a series of successive study parts, is to~     methodically evaluate Phonak Hearing Systems on hard of hearing participants to grant quality~     control prior to each product launch.~   "
62039|NCT02754830|"~     The purpose of this study is to evaluate the safety and tolerability of the study drug,~     LY3303560. Side effects and laboratory results will be monitored. This study will involve~     single doses of LY3303560 administered intravenously (IV), meaning into a vein or~     subcutaneously (SC), meaning under the skin.~      Screening is required within 28 days before the start of the study for healthy participants~     and within 42 days before the start of the study for AD participants. The study requires~     about 16 weeks of each participant's time including a 4 day clinical research unit (CRU)~     admission and 10 follow-up appointments.~      This is the first time that this study drug is being given to participants. This study is for~     research purposes only, and is not intended to treat any medical condition.~   "
62040|NCT02754817|"~     This study is conducted in Europe. The aim of the study is to investigate the effectiveness~     of Xultophy® (insulin degludec/liraglutide) in an adult real-world population with type 2~     diabetes mellitus.~   "
62041|NCT02754804|"~     Vascular claudication is a common cause of functional limitation. This painful condition is a~     source overall muscle deconditioning in the peripheral arterial diseased (PAD) patient~     leading gradually to a state accented inactivity. The characterization of the claudication as~     it results from a proximal or distal ischemia has never carried out. Investigators will~     analyze dynamic pedometer parameter throughout walking tests in PAD patients with~     claudication~   "
62042|NCT02754791|"~     Bloodstream infections cause significant morbidity and mortality and their prompt~     identification is an essential part of modern medicine. False positive results in blood~     cultures are primarily due to contaminants. It has been estimated that up to 50% of positive~     blood cultures represent contamination. These false positive cultures, at the microbiological~     laboratory level, require significant additional resources for workup. Additionally, they~     result in unnecessary antibiotic treatment and hospitalization days, causing needless harm to~     patients. Various methods have been implemented in order to reduce blood culture~     contaminants, including modifying the solution used for sterilizing the skin and feedback on~     contamination rates. However, it has been shown that the bacteria which colonize the human~     skin are not only on the surface but in fact colonize deeper surfaces as well. The SteriPath~     device diverts the initial 1-2 ml blood so as to remove any potential skin plug with~     contaminants. Thus, the principle object of this study is the determination of the rate of~     contamination of blood culture taken prior to initiating intervention versus the rate of~     contamination using three interventions: Monthly feedback via departmental report card, a~     chlorhexidine plus alcohol wipe and the SteriPath device. Secondary objectives will include~     ease of use of the wipes and the SteriPath device and an estimate of the sensitivity of~     SteriPath device use to true bacteremia. If the various interventions will be shown to reduce~     contamination, researchers will also attempt to estimate the financial effects of those~     reductions, comparing intervention cost to estimated savings related to reduced~     contamination.~   "
62043|NCT02754778|"~     Evaluation of practicability in survey and test procedures and of successful implementation~     of complex interventions - feasibility analysis based on a pilot study: Influence of~     conditional workout postpartum on arterial stiffness among women with status after~     preeclampsia, superimposed preeclampsia or HELLP-syndrome~   "
62044|NCT02754765|"~     endTB Clinical Trial a Phase III, randomized, controlled, open-label, non-inferiority,~     multi-country trial evaluating the efficacy and safety of five new, all-oral, shortened~     regimens for multidrug-resistant tuberculosis (MDR-TB).~   "
62045|NCT02754752|"~     The goal of this clinical research study is to compare 3 types of interventions (involving~     electro-acupuncture and standard care) that are given to women with chronic post-surgical~     pain after a mastectomy. Researchers want to find out which intervention may be most~     effective in relieving breast pain. The safety of these 3 interventions will also be studied.~      This is an investigational study. Acupuncture needles are an FDA approved medical device, but~     acupuncture therapy itself is considered investigational.~      Up to 109 participants will be enrolled in this study. All will take part at MD Anderson.~   "
62046|NCT02754739|"~     An increased risk of incident diabetes with statin therapy have been reported in several~     studies. However, it is not recommended to limit the use of statin for this reason since the~     absolute risk increase was small, and the cardiovascular event rate reduction with statins~     overweighed the risk of new diabetes (Scatter N et al. Lancet, 2010). Moreover, each statin~     may have different effect on the development of incident diabetes. In the West of Scotland~     Coronary Prevention Study, pravastatin therapy reduced the hazard of becoming diabetic by~     30%. Also, with pravastatin use, an increase in adiponectin level, which is related to the~     improvement in insulin sensitivity, has been reported. In this clinical trial, the~     investigators are aiming to evaluate the effect of pravastatin on insulin resistance, insulin~     secretion, glycemic control, and adiponectin level in participants with prediabetes or early~     diabetes by assigning them in a 24 weeks of pravastatin therapy group or in a placebo group.~   "
62047|NCT02754726|"~     The purpose of this study is to find out if the study drugs nivolumab, albumin- bound~     paclitaxel, paricalcitol, cisplatin, and gemcitabine given together are safe and effective~     when combined to treat advanced pancreatic cancer.~   "
62071|NCT02754414|"~     This is a platelet transfusion study. The purpose of this study is to measure the life span~     and quality of platelets stored in a refrigerator. Participants will give platelets by~     apheresis. Platelets will be stored for 3 -20 days. A small portion of the subject's own~     stored platelets will be tagged with a radioactive isotope and infused back into the~     participant. This will enable us to track how many transfused platelets survive after storage~     in the refrigerator.~   "
62048|NCT02754713|"~     The study will aim at investigating novel plasma or imaging biomarkers in patients with acute~     pericarditis. All participants will be treated according to established clinical~     recommendations for the diagnosis and treatment of acute pericarditis.~      Study participants will undergo blood sampling for measurements of plasma biomarkers~     potentially involved in the pathogenesis of acute pericarditis. Imaging datasets from~     available imaging tests will be used to quantify imaging biomarkers. Patients will be~     followed up prospectively for up to 18 months. The prognostic value of plasma and/or imaging~     biomarkers for development of complications such as atrial fibrillation, pericarditis~     recurrences, constrictive pericarditis and/or the need to switch to 2nd line treatment will~     be sought.~   "
62049|NCT02754700|"~     This study will identify the most optimal, focused approach for biofeedback in adolescent~     females at high risk for anterior cruciate ligament (ACL) injury. A six-week randomized,~     pre/post-testing design will be used to identify biofeedback training effects. The~     investigators will also determine the effects of hip strategy on retention of decreased knee~     abduction load with focused biofeedback. A six-month follow-up design will be used to test~     retention of real-time biofeedback intervention.~   "
62050|NCT02754687|"~     The long term objective is to develop a new male hormone 11-β Methyl Nortestosterone~     Dodecylcarbonate (11β-MNTDC) as a male hormonal contraceptive.~   "
62051|NCT02754674|"~     1. Purpose :To compare of femoral tunnel placement, tunnel geometry and clinical outcome~          using two anterior cruciate ligament reconstruction techniques ; transportal technique~          with flexible reamer and single bundle outside in technique with remnant preservation.~        2. Subjects: anterior cruciate ligament (ACL) injury 66 patients~             -  Double bundle transportal technique with flexible reamer: 33~             -  Single bundle outside in technique with remnant preservation: 33~   "
62052|NCT02754661|"~     The primary objective of this multicenter, prospective, randomized study is to assess the~     diagnostic yield of CCE versus CTC in a screening population.~   "
62053|NCT02754648|"~     Is ovarian reserve and fecundity rate higher with laparoscopic ovarian aspiration rather than~     laparoscopic ovarian cystectomy and laparoscopic ovarian de-roofing in infertile woman with~     ovarian endometrioma or not?~   "
62054|NCT02754635|"~     Induction of labor at term versus expectant management among women with abnormal maternal~     biochemical markers. A randomized controlled trial~   "
62055|NCT02754622|"~     Many patients who are admitted to the intensive care unit (ICU) experience muscle weakness.~     This muscle weakness occurs whilst patients are unconscious, immobile in bed and on a~     breathing machine (ventilator). It can develop very quickly, as soon as they become unwell.~     The investigators know that this weakness can make it harder for patients to regain their~     normal level of functional ability, such as standing and walking independently. Physical~     rehabilitation, delivered by physiotherapists, is important for patients as they recover from~     their critical illness to help them regain strength and to practice the ability to perform~     physical activities. These activities include sitting on the edge of the bed, standing,~     stepping on the spot and walking.~      However it is difficult to know how hard it is for patients who are recovering from critical~     illness to perform these types of activities - in other words, how much energy is required.~     Some patients may find certain activities harder or easier than others. By knowing the energy~     requirements of patients whilst they take part in different physical rehabilitation~     activities, physiotherapists may be able to be more accurate with prescribing exercises and~     designing rehabilitation sessions for patients to practice achieving those activities.~      In this study, the investigators will measure the energy requirements of the patients when~     they take part in physiotherapy-led physical rehabilitation they will have during their~     admission. To do this, the investigators will use a different ventilator to the one normally~     used to help their breathing. This ventilator works in exactly the same way, but has an extra~     component built into it to measure energy requirements. After the rehabilitation session, the~     patient will return to using their normal ventilator.~   "
62056|NCT02754609|"~     This trial is a Phase 1b multicentre, multinational, randomized, double-blind with~     single-blind arm and open label extension phase, placebo controlled, clinical trial~     evaluating the safety and predictability of an escalating gluten consumption to activate~     Coeliac Disease (CeD) in (a) a small cohort of people with diet-managed CeD treated with a~     placebo (n=10), and in (b) cohorts following low (L3-10; n=40) and medium (L3-20; n=10) dose~     hookworm inocula.~      The investigators 4 aims for the study are:~      Aim 1: Undertake a multiple-phase and escalating gluten challenge assessing safety to gluten~     exposure in hookworm-naïve and hookworm-infected people with CeD.~      Aim 2: This phase Ib study recognizes that the evidence supporting this novel intervention is~     rudimentary and addresses amongst others the following questions: (a) The importance of L3~     dose on Participant health, and (b) the importance of L3 dose on the safety of escalating~     gluten challenge and (c) the need for a comparator group should a phase II trial be~     warranted.~      Aim 3: Examine the changes in intestinal T cell responses induced by hookworm infection and~     gluten exposure.~      Aim 4: Assess the impact of hookworm infection and purified hookworm-derived proteins on~     gluten peptide-specific immune responses ex vivo.~   "
62057|NCT02754596|"~     This is a randomized trial comparing two elution doses of the Travoprost Intraocular implant~     to timolol ophthalmic solution.~   "
62058|NCT02754583|"~     SWIFT is a series of 3 cluster-randomized trials designed to assess several alternative~     strategies for trachoma control in communities that have been treated with many years of mass~     azithromycin distributions. The first trial (named WUHA) compares communities that receive a~     comprehensive Water, Sanitation, and Hygiene (WASH) package to those that receive no~     intervention. The second trial (named TAITU-A) compares communities randomized to targeted~     antibiotic treatment versus those randomized to mass antibiotics for trachoma, and the third~     trial (TAITU-B) compares communities randomized to targeted antibiotics versus those~     randomized to delayed antibiotics.~   "
62059|NCT02754570|"~     The aim of this study will be to determine the effects of pilocarpine as an adjunct~     medication to latanoprost monotherapy at multiple intervals throughout a 24-hour period and~     compare these effects to latanoprost alone.~   "
62231|NCT02752334|"~     This study evaluated the motor and sensory block duration and the postoperative analgesic~     effects of adding Magnesium Sulphate to bupivacaine in the ultrasound-guided supraclavicular~     brachial plexus block Anesthesia. Motor and sensory block duration were considered as a~     primary endpoint.~   "
62060|NCT02754557|"~     The purpose of the study is to compare the efficacy of a physiologically-augmented~     breath-focused mindfulness-based intervention to reduce symptoms of dissociation that are~     associated with psychological trauma, as well as symptoms of posttraumatic stress disorder~     (PTSD). The study will evaluate whether physiological augmentation produces a greater change~     in dissociative symptoms, meditative engagement and attentional control, compared to~     non-augmented mindfulness. The augmentation comprises physiological feedback in the form of a~     vibration on the wrist. Vibrations are delivered by a device that will be placed on a~     participant's arm; the device vibrates in proportion to the person's breath.~   "
62061|NCT02754544|"~     The goal of this clinical research study is to learn if using a larger than the standard~     mapping grid currently used at MD Anderson during brain tumor surgery or a high-definition~     grid for electrocorticogram (ECoG) brain mapping can help better identify which areas of the~     brain are active during specific limb movement and speech. In this study, the result of two~     types of ECoG mapping grids will be analyzed.~      ECoG mapping will take place during your scheduled surgery. Before the procedure, you will be~     assigned one of the two types of mapping grids. The mapping grid will be placed directly on~     the surface of your brain during surgery. You will not be able to feel this. The grids~     contain electrodes attached to a computer to record brain activity. A wireless digital glove~     will be used with the high-definition grid. The glove records hand movements, while the grids~     shows the areas of the brain that are active during the hand movements.~      This is an investigational study. The fMRI, TMS procedure, and direct electrical stimulation~     are FDA-approved procedures. Both PMT and AdTech mapping grids are FDA-approved and~     commercially available.~      ECoG mapping utilizing the PMT grids during brain tumor surgery is FDA-approved and currently~     used at MD Anderson. The AdTech grid is FDA-approved and was previously used in MD Anderson.~     ECoG mapping utilizing these grids is currently being used for research purposes only and~     will be performed at no charge to you while you are on study.~      Up to 20 participants will be enrolled in this study. All will take part at MD Anderson.~   "
62062|NCT02754531|"~     This study aims to compare the accuracy of measurement between ultrasonography and Cole~     formula in predicting uncuffed endotracheal tube diameter.~   "
62063|NCT02754518|"~     This study intends to measure the effects of valsartan/sacubitril compared to baseline~     standard medical heart failure therapy on reverse remodeling using echocardiographic~     endocardial surface analysis techniques to assess changes in ventricular volume, function,~     and shape. Furthermore, Metaiodobenzylguanidine (MIBG) scintigraphy and the heart to~     mediastinum ratio will be used to assess Left Ventricle (LV) volume regression and risk~     reduction. The investigators also intend to measure the effects of valsartan/sacubitril on~     exercise capacity as assessed by the 6 minute walk test and peak Volume of Oxygen (V02) on~     cardiopulmonary exercise testing. Additionally, the investigators will examine the impact of~     valsartan/sacubitril on functional status and quality of life using the Kansas City~     Cardiomyopathy Questionnaire (KCCQ) and Qualia Health (a novel iPhone application that~     incorporates Fitbit technology to provide a real time daily 6 minute step count and~     assesses quality of life using a series of short targeted questions. The investigators will~     also measure Brain Natriuretic Peptide (BNP), N-terminal of the Prohormone Brain Natriuretic~     Peptide (NT-proBNP), and Rho-kinase (a biomarker associated with heart failure) levels at~     multiple time-points throughout the study period.~   "
62064|NCT02754505|"~     Background: Few studies showed that early rehabilitation on the Intensive Care Unit (ICU)~     results in a better functional outcome at hospital discharge and reduced hospital stay.~     Effects of early rehabilitation at the general ward directly after transfer from the ICU on~     the length of stay (LOS) in hospital and on the functional outcome are missing.~      Methods: In a prospective randomised controlled trial (RCT) 53 consecutive~     critical-illness-survivors were enrolled at nine ICUs. Early rehabilitation program~     (protocol) consisted of exercise therapy, active breathing techniques and electrical~     stimulation after discharge from the ICU to ward-based care. The usual care group received~     physical therapy as ordered by the primary care team after discharge from the ICU. LOS at the~     general ward after transfer from the ICU was recorded. Furthermore,~     Early-Rehabilitation-Barthel-Index (ERBI), Visual-Analogue-Scale for pain (VAS),~     3-Minute-walk-test (3min), Beck-Depression-Inventory (BDI), State-Trait-Anxiety-Inventory~     (STAI), and Medical-Research-Council-scale (MRCS) were assessed.~   "
62065|NCT02754492|"~     To verify that platelets collected on the Trima Accel system with Version 7.0 software~     enhancements and stored in 100% plasma meet the FDA requirements for leukoreduction (< 5.0 ×~     10^6 residual white blood cells [WBC] per transfusable unit).~   "
62066|NCT02754479|"~     To evaluate the safety and effectiveness of the Excel V system for the treatment of lower~     extremity spider veins on the ankles.~   "
62067|NCT02754466|"~     The present study aims evaluate the oral health conditions of schoolchildren and its relation~     to growth, development and well-being. Also, it seeks to evaluate different restorative~     interventions performed at school premises in primary teeth and its impact on the quality of~     life.~   "
62068|NCT02754453|"~     There are three different phases to this study:~        1. Screening phase to determine if you are eligible to participate in the study.~        2. Study phase, which will entail diet and activity, exercise and then finally self~          monitoring goals.~        3. End of treatment phase where you will be asked to complete questionnaires.~   "
62069|NCT02754440|"~     To verify that platelets collected on the Trima Accel system with Version 7.0 software~     enhancements and stored in platelet additive solution (PAS) meet the FDA requirements for~     leukoreduction (< 5.0 × 10^6 residual white blood cells [WBC] per transfusable unit).~   "
62070|NCT02754427|"~     Breast cancer treatment often results in long-term arm morbidity. A prospective surveillance~     model with arm assessment pre-surgery followed by ongoing surveillance and targeted~     physiotherapy treatment after breast cancer surgery may improve early detection and~     management of arm morbidity. This study aims to determine the effect of prospective~     surveillance to target physiotherapy on the prevalence of arm morbidity in the surveillance~     group compared to control group at 12-months after breast cancer surgery.~   "
62230|NCT02752347|"~     Compare the impact of using rapid maxillary expanders on masticatory muscle activities~     (Masseter and Anterior Temporalis muscles) among different posterior cross-bite patient~     (unilateral, bilateral) as well as compare the cross-bite side and non-cross-bite sides of~     the same preadolescent unilateral crossbite patient before the expansion and after one month~     of the completion treatment period using surface electromyography device.~   "
62072|NCT02754401|"~     200 patients took part in the questionnaire and were examined using the PSI. Thereafter the~     participants were divided into two groups, non-periodontitis persons (group 1; PSI 0-2) and~     periodontitis persons (group 2; PSI 3-4). The answers were evaluated using a point system~     ranging from 0 to 8, based on known periodontal risk factors and their assumed degree of~     influence. Receiver-operating characteristic (ROC) curve analyses were applied to examine the~     overall discriminatory power, sensitivity and specificity, and corresponding cut-off points~     of the self-reported periodontal disease scale.~   "
62073|NCT02754388|"~     Lung cancer is one of the leading causes of cancer-related death in Taiwan. Early diagnosis~     of lung cancer may improve cancer survival. Low-dose computed tomography (LDCT) was thought~     to be the best screening tool for lung cancer. However, there is growing concerns about~     radiation exposure, high cost, and high rate of false-positive screening result.~     Epidemiologic studies from western countries showed that cigarette smoking is the major cause~     of lung cancer, and other risk factors may include age, environmental pollution, occupational~     exposures (included of radon exposure), gender, race, and pre-existing lung diseases.~     Adenocarcinoma is the major type of lung cancer in Taiwan and is less attributable to~     smoking. The investigators need a different risk prediction model adapted to the~     investigators country.~      National Taiwan University Hospital Chu-Tung Branch initiated the lung cancer screening by~     LDCT since June 2015. Many people can get the LDCT screening with affordable price with the~     subsidy from enterprise donation. The purpose of this study is observing those participants~     with 2-year follow-up. Furthermore, those data may connect with another study of Low dose~     computed tomography screening study in nonsmoker with risk factors for lung cancer in Taiwan~     （Non-smoker study）which is implemented in other hospitals in Taiwan.~   "
62074|NCT02754375|"~     Biological markers of depressive states have been studied, but their usefulness to predict~     the therapeutic response is unknown. This issue is major in all depressive states which have~     not remitted after several lines of treatment. rTMS (repetitive transcranial magnetic~     stimulation) is a non-pharmacological alternative in the treatment of depression, but its~     effects on cerebral functioning are not known in episodes which have resist to conventional~     treatments. The investigators will include 50 depressive patients who have failed to respond~     to two successive antidepressant medication, and propose them a treatment with low frequency~     rTMS during 3 to 6 weeks. Cerebral functional imaging with 18FDG-PET (positon emission~     tomography) with be assessed at the beginning and at the end of rTMS acute treatment, in~     order to measure induced metabolic changes and their correlation with clinical states.~     Patients who have responded to rTMS acute treatment may continue this therapeutic for six~     months, and the investigators will assess if efficacy maintenance is related with cerebral~     metabolic variations~   "
62075|NCT02754362|"~     This is a phase II study to determine the immunogenicity and efficacy of a vaccine composed~     of tumor associated long synthetic peptides mixed with Montanide ISA-51 VG administered with~     polyinosinic-polycytidylic acid - poly-L-lysine carboxymethylcellulose (Poly-ICLC) and~     bevacizumab in adults with recurrent glioblastoma.~   "
62076|NCT02754349|"~     This study aims to evaluate the reliability of measurements of arterial stiffness (pulse wave~     velocity (PWV), pulse wave contour analysis (PWA), central augmentation index (AIx) and pulse~     pressure (PP)) in atrial fibrillation (AF). For this purpose 30 AF patients scheduled for~     electrical cardioversion will be included. PWV and PWA measurements will be carried out~     before and after cardioversion.~   "
62077|NCT02754336|"~     This pilot study compares the effect of working memory training and neurofeedback in~     non-medicated children age 7 to 13 years with ADHD. Half of the participants will receive~     working memory training, while the other half will receive neurofeedback.~   "
62078|NCT02754323|"~     There are different definitions of stress according to each discipline. In psychology, it is~     defined according to the individual's ability to adapt. The medical approach focuses on the~     reactions of the body to stress situations. And the organizational approach seeks to define~     in terms of sources of stress situations. According to a national interprofessional agreement~     on stress at work in 2008 is defined as a condition that occurs when there is an imbalance~     between the perception of a person with constraints imposed by its environment and the~     perception that it has its own resources to cope.~      Stress at work~      INRS emphasizes prevention to fight against the cost of work stress and seeks to develop~     methods and tools objectification stressful situations. The social cost of workplace stress~     would represent 10 to 20% of the expenses of the branch for employment injuries /~     occupational diseases of the Social Security According to a survey by the European Agency for~     Safety and Health at Work conducted in 1999, stress is the cause of 50 to 60% of all lost~     working days. The cost of occupational stress assessed by INRS represent 830 million euros in~     2000 in France.~      Media coverage of working conditions related suicides has prompted some companies to~     communicate about work stress and develop actions.~      According to the study of Sumer in 2003, 61% of employees have a highly stressful job and 27%~     complained of work-related health problems.~      However, the 2009 survey shows that job stress is a major risk factor for mental health and~     is associated with decreased job performance. Burnout sets in stages idealistic enthusiasm,~     stagnation, frustration, apathy. Therefore, it is essential to track the state of chronic~     stress as soon as possible to prevent burnout.~      Stress testing procedures~      The major problem is that there is not now comprehensively measure of stress. The measurement~     models that are available to date, all incomplete, can be classified according to two~     categories.~      First, the general patterns that measure only partially stress but which can be used in any~     type of fields. One application of self-KARASEK and the imbalance of effort / reward~     SIEGRIST. These two models are mainly used for epidemiological studies on job stress.~      Second, the specific models that provide a more comprehensive measure but we can only use in~     the area from which they come. These measure specific stressors (organizational, professional~     and emotional) in the study population.~      The main objective of this study is evaluate the feasibility and validate the measurement of~     chronic stress by CODESNA tool. The method is to compare the measured result by the CODESNA~     tool to measure stress questionnaires collected by the Maslach Burnout INVENTORY and KARASEK.~     This method explores finely enough constraints and allows a comparison of national data.~   "
62079|NCT02754310|"~     Repeated exposure to simulated cases has been shown to improve performance, but repeating the~     same scenario may impair the ability of learners to transfer their knowledge and skills to~     slightly different situations. The objective of this study is to compare the use of repeated~     versus varied simulation cases for teaching the management of pediatric asthma exacerbation~     to 3rd year medical students.~   "
62090|NCT02754167|"~     Anticalins® are engineered human proteins that are able to bind specific target molecules.~     The Anticalin PRS-080#022-DP to be investigated in this study is directed against hepcidin~     and is intended for the treatment of anemia of chronic disease. This Phase Ib study shall~     investigate the safety, pharmacokinetics and pharmacodynamics of a single administration of~     PRS-080#022-DP in anemic stage 5 chronic kidney disease patients undergoing hemodialysis.~   "
62091|NCT02754154|"~     The purpose of this study is to compare the risk of major bleeding event among nonvalvular~     atrial fibrillation patients treated with warfarin, apixaban, dabigatran and rivaroxaban.~   "
74883|NCT02586753|"~     The purpose of this study is to determine which regimen is better for esophageal squamous~     carcinoma in concurrent chemoradiation(CCRT),paclitaxel or S1 plus cisplatin.~   "
62080|NCT02754297|"~     In this study, peptide receptor radionuclide therapy (PRRT) with 177Lu-Octreotate (LuTate)~     will be personalized, i.e. administered activity of LuTate will be tailored for each patient~     to maximize absorbed radiation dose to tumor, while limiting that to healthy organs.~      The purpose of this study is to:~        -  Assess the objective (radiological), symptomatic and biochemical response rates~          following an induction course of personalized PRRT;~        -  Assess the overall, the disease-specific, and the progression-free survival following~          P-PRRT;~        -  Correlate therapeutic response and survival with tumor absorbed radiation dose;~        -  Evaluate the acute, subacute and chronic adverse events following P-PRRT;~        -  Correlate toxicity (i.e. occurence and severity of adverse events) with absorbed~          radiation doses to organs at risk;~        -  Optimize the quantitative SPECT imaging-based dosimetry methods in a subset of 20~          patients (sub-study funded by the Canadian Institutes of Health Research).~      This study also has a compassionate purpose, which is to provide access to PRRT to patients.~   "
62081|NCT02754284|"~     This study is carried out to explore the short-term and long-term efficacy of the functional~     collagen scaffold in guiding laryngeal soft tissue regeneration.~   "
62082|NCT02754271|"~     Exercise training for older hemodialysis patients can greatly improve many of the negative~     effects and poor health outcomes associated with end-stage kidney disease. Exercise has yet~     to be incorporated effectively and systematically into routine care. Exercise programs remain~     rare. When such programs are implemented, their participation rates vary, and they neglect~     home and community-based activities, as well as the involvement of family caregivers to~     support and reinforce exercise. This study is intended to address these limitations by~     introducing a highly accessible and compelling educational film, Fit for Dialysis, designed~     to introduce, motivate, and sustain exercise for wellness amongst older hemodialysis~     patients, and exercise counseling and support by family caregivers, nephrologists, and~     nurses. The objective of this clinical trial is to determine whether and in what ways Fit for~     Dialysis improves outcomes and influences knowledge/attitudes regarding the importance of~     exercise-based principles of wellness in the context of end-stage renal disease. Ultimately~     Fit for Dialysis could be used as a model for dialysis education that supports guideline~     recommendations that exercise be incorporated into the care and treatment of dialysis~     patients.~   "
62083|NCT02754258|"~     The Problem: Obesity is one of the leading causes of chronic disease and death. The efficacy~     of diet and exercise to sustain weight loss over the long term is weak. While pharmacotherapy~     is more effective than behavior intervention in maintaining weight loss the effects are often~     not sufficient to achieve optimal health benefits. Current drug treatments may be sub-optimal~     because they do not directly target the rewarding value of food, drive to eat, food liking,~     and impulsivity for eating energy dense snack foods, all of which influences both quantity~     and quality of food intake and impacts adherence needed to maintain weight loss.~      The Solution: The limitations in current anti-obesity agents are potentially addressed by~     Methylphenidate (MPH). We showed that MPH reduces food intake, dietary fat intake, hunger and~     food reward, as increase resting energy expenditure in obese and non-obese adults;however, no~     controlled field trials have been conducted in obese individuals without ADHD.~      Objectives/Hypotheses: Primary: To test the effects of MPH on energy intake in obese men and~     women. Secondary: to examine the effects of MPH on energy expenditure, body weight,~     impulsivity, food reward, and olfaction. The investigators predict that compared to placebo,~     MPH will show reduced appetite, along with reduced impulsivity, food reward, and smell~     function.~      Deliverable: This study may be the first to establish the short-term efficacy and safety of~     using MPH for weight loss, and if successful, data will inform a larger trial that can~     potentially identify MPH as a novel therapeutic agent for treating obesity and related~     chronic diseases in a predisposed population.~   "
62084|NCT02754245|"~     The aim of this study is to externally validate a new emergency department overcrowding~     estimation tool (SONET) developed at John Peter Smith Health Network (JPS).~   "
62085|NCT02754232|"~     Problem:~      Training is an important part of the treatment and rehabilitation of patients with chronic~     obstructive pulmonary disease (COPD) because training can increase the patient's muscle mass,~     lead to higher physical performance, reduce difficulties in breathing and hereby increase the~     patients' capacity to make use of the medical treatment.~      Rehabilitation is provided by hospitals training centres/outpatient clinics. However, the~     transport is too tiring for the patients, which is why they decline taking part in it. This~     can mean a worsening of their condition and an increase in readmissions.~      Solution:~        -  To develop a better treatment for patients with severe COPD: Telemedical training of~          patients with COPD in teams.~        -  To develop a cross-sectoral practice for the telemedical training patients will use,~          thus decreasing the readmissions of OUH's patients with severe COPD~        -  To optimize the patient's journey in and across sector borders by using Lean methods.~      Perspective:~      The study is expected to contribute to improving treatment of severely ill patients with COPD~     cross-sectorally. The results are expected to contribute to reducing readmissions and raising~     the level of evidence in telemedical research on training patients with severe COPD. The~     study's findings may be of use in relation to other patient groups who have difficulties~     coming to training.~      Background:~      This research project has its starting point in a pilot project. Its goal was to determine~     whether severely ill COPD patients could train at home and earlier than normal. Evaluation~     showed patients found it reassuring to train with the help of the COPD briefcase. They found~     it increased their physical and mental well-being.~      Method:~      To gain knowledge of the effect of telemedical training. The patient's strength, daily~     activity level and quality of life will be measured by conducting a randomized controlled~     trial including 125 patients - 62 in the intervention group and 62 in the control group.~      Qualitative research methods will be used to explore the user perspective concerning~     patients, family and health professionals. The method is critical psychological practice~     research.~      A Lean method consultant from University Hospital Odense (OUH) will be involved in developing~     the best clinical pathway for the patients and the professionals.~   "
62086|NCT02754219|"~     The objective of the study is to compare the pharmacokinetics profiles and safety of~     Evogliptin in patients wit hepatic dysfunction versus healthy volunteers after single oral~     dose of Evogliptin~   "
62087|NCT02754206|"~     The purpose of this study is to understand how biochemical markers in blood, balance~     disturbances, and cognitive performance are related to brain blood flow changes after a~     concussion.~   "
62088|NCT02754193|"~     A multicenter, prospective, controlled, randomized (moderate hypothermia 33°C≤ T°C ≤34°C)~     during 24 hours ± 1h versus normothermia (37°C ± 0.3 °C), comparative open trial will be~     conducted on two parallel groups of patients with cardiogenic shock treated with VA-ECMO.~      The HYPO-ECMO trial will test the hypothesis that moderate hypothermia (temperature between~     33°C≤ T°C ≤34°C) associated with VA-ECMO support results in a reduction in 30-day mortality~     in comparison with the normothermia group (37°C ± 0.3°C).~   "
62089|NCT02754180|"~     Adjuvant Gemcitabine Versus Gemcitabine With Chemoradiation in Pancreatic Adenocarcinoma With~     R1 Resection and/or Positive Lymph Nodes after curative resection.~   "
62093|NCT02754128|"~     The purpose of this study is to compare a motor learning (ML)-based gait-related training~     intervention to a functional lower limb strength training intervention, with a concurrent~     evaluation of functional, neural and participation outcomes for children and youth with~     Cerebral Palsy (CP).~      This study is a two-group, parallel arm RCT in which twenty-two children with CP in GMFCS~     Levels I-II will be randomly allocated to a 6-week, 16 session program of: (i) ML based gait~     training or (ii) lower limb strength training. Outcome assessments occur pre/post/4-months~     post-intervention.~   "
62094|NCT02754115|"~     Peritoneal carcinomatosis is a common event in the natural history of colorectal and other~     digestive tract cancers. Cytoreductive surgery (CRS) and hyperthermic intraperitoneal~     chemotherapy (HIPEC) provides a promising therapeutic option for highly selected patients~     with peritoneal carcinomatosis arising from different malignancies such as colorectal cancer,~     gastric cancer, ovarian cancer, or peritoneal mesothelioma with improvement of both patient~     survival and quality of life. CRS, i.e., removal of all visible metastatic abdominal and~     pelvic disease with peritonectomy along with HIPEC (for 90 min at a temperature of 42º C)~     and/or early postoperative intraperitoneal chemotherapy (EPIC) in order to eradicate all~     microscopic metastasis.~      CRS with HIPEC is a long and complex procedure with significant blood and fluid loss during~     debulking, hemodynamic, hematological, and metabolic alterations before and during the HIPEC~     phase, and even in the early postoperative period, with resultant significant morbidity and~     mortality. Despite that most of the reported patients are in American Society of~     Anesthesiologist class I and II, without significant comorbidities or systemic disorder; the~     morbidity and mortality ranges from 12 to 65% in these procedures, so a well coordinated team~     of anesthesiologist, surgeons and intensivist and other ancillary services can result in good~     outcome. This study will see the challenges faced by the team regarding the~     pathophysiological alterations during the CRS with HIPEC in the perioperative period.~   "
62095|NCT02754102|"~     To determine the phototoxic potential of a topically applied article in human subjects.~   "
62096|NCT02754089|"~     The aim of this study is to evaluate the effects of Rhus coriaria L. (Rhus) commonly known as~     Somagh on body weight.~   "
62097|NCT02754076|"~     The study's primary objectives are to evaluate the safety and tolerability of BMN 250~     administered to subjects with MPS IIIB via an ICV reservoir and catheter and to evaluate the~     impact of BMN 250 on cognitive function in patients with MPS IIIB as assessed by the~     Development Quotient.~   "
62098|NCT02754063|"~     Post-traumatic brain hypoxia/ischemia develops hours after traumatic brain injury (TBI), and~     its intensity is directly related to the neurological outcome. The thresholds for~     irreversible tissue damage following TBI indicate a particular vulnerability of injured~     brain. Improving brain oxygenation after severe TBI is the focus of modern TBI management in~     the intensive care unit (ICU).~      The calculation of cerebral perfusion pressure (CPP), with CPP = mean arterial pressure (MAP)~     - intracranial pressure (ICP), has become the most used estimator of cerebral blow flow. To~     prevent ischemia due to elevated ICP, current international guidelines recommend maintaining~     CPP at 60-70 mmHg and ICP below 20 mmHg. However, episodes of brain hypoxia/ischemia, as~     assessed with brain tissue oxygen pressure (PbtO2) measurements, might occur despite~     optimization of CPP and ICP, and have been independently associated with poorer patient~     outcome. PbtO2 values lower than 15 mmHg for more than 30 minutes were shown to be an~     independent predictor of unfavorable outcome and death. The aggressive treatment of low PbtO2~     was associated with improved outcome compared to standard ICP/CPP-directed therapy in cohort~     studies of severely head-injured patients. On the basis of these findings, it is hypothesized~     that an early optimization of brain oxygenation, together with keeping ICP and CPP within~     recommended values, could reduce the volume of vulnerable lesions following severe TBI and~     possibly improve neurological outcome.~   "
62099|NCT02754050|"~     The device is intended to endoscopically transect polyps in the gastrointestinal tract~     (sessile or pedunculated) using electrocautery. During the same maneuver the polyp is~     captured, retrieved and submitted for pathological analysis. The Tandem Snare is an~     intervention tool inserted through the colonoscope for the resection and removal of polyps~     sized 6 to 25 mm. The Tandem snare utilizes a technology that has the potential to hold the~     polyp, lift it up, resect and remove it without losing it. This is a feasibility study aiming~     to demonstrate the safety of the Tandem Snare used for 6-25mm polyps' polypectomy in~     screening, diagnostic or surveillance colonoscopy.~   "
62100|NCT02754037|"~     The goal of this study is to evaluate non-invasive imaging techniques for determining liver~     steatosis (fat), inflammation (abnormal tissue swelling), and fibrosis (abnormal tissue~     scarring).In addition, the study group will be using other test measures including personal~     demographics, laboratory blood test results, and imaging measurements to determine the~     severity of NAFLD (non-alcoholic fatty liver disease), NASH (non-alcoholic steatohepatitis),~     inflammation, and fibrosis.~   "
62101|NCT02754024|"~     In the past years several shoulder reconstruction systems with different types of prostheses~     and fixation methods have been developed to improve shoulder arthroplasty, trying to cover a~     wide range of pathologies and revision situations. The aim of the present study is to report~     radiological and clinical outcome with a stemless shoulder implant with hollow screw~     fixation.~   "
62102|NCT02754011|"~     The proposed study is a multicenter, open-label phase I trial, conducted in locally advanced~     or metastatic breast cancer HER2 negative patients and divided into 2 parts:~        -  STEP 1: a dose escalation part (n= up to 30) to evaluate the safety profile and~          pharmacokinetics and to define the MTD and RP2D to recommend in a phase II.~        -  STEP 2: an expansion cohort part to confirm the safety and tolerability of ribociclib~          and capecitabine association on a longer follow-up, and to obtain preliminary evidence~          of anti-tumor activity on two expanded cohorts of HR positive and HR negative patients.~          Up to 14 patients in each cohort, taking into account patients already included in step~          one at this DL, may be enrolled, for a total of 28 at the RP2D.~   "
62152|NCT02753361|"~     There is limited information on using the ultrasonography for block placement concerning~     lipoma excision. A new type of regional blockade, performed under ultrasound, can ensure~     proper block placement with accurate local anesthetics deposition. Investigators hypothesized~     that ultrasound guidance can reduce the number of needle passes to complete the block~     placement. Investigators will compare namely ultrasound guided regional blockade and~     traditional method regarding the number of needle passes to complete the block placement.~   "
62103|NCT02753998|"~     The primary objective of this double-blind study is to compare the frequency of primary~     patency at 6 months in patients with stenosis of arteriovenous fistula (AVF) treated either~     by conventional angioplasty + angioplasty with balloon impregnated with paclitaxel or by~     conventional angioplasty + angioplasty with placebo balloon (balloon not impregnated with~     paclitaxel).~      The other objectives of the study are:~        1. To compare the frequency of primary patency at 3 months and 12 months.~        2. To compare the rate of restenosis > 50% at the site of angioplasty at 3, 6 and 12~          months.~        3. To compare, at 3, 6 and 12 months, the proportion of patients with arteriovenous fistula~          deteriorating back to preoperative flow rate (within 20% of preoperative flow rate).~        4. To compare, at 3, 6 and 12 months, the proportion of AVF with a flow rate < 500 ml /~          min.~        5. To compare, at 3, 6 and 12 months, the cumulative rate of thrombosis.~        6. To compare, at 3, 6 and 12 months, the medical costs related to direct medical care,~          initial treatments, monitoring, diagnosis and treatments of complications.~   "
62104|NCT02753985|"~     This is a qualitative study which explores the role that partners play in breast cancer~     survivors adherence to aromatase inhibitors and management of their side effects. Both~     patients and their partners will be interviewed (separately) in order to capture multiple~     perspectives. The target number of subjects is 64 (32 patients and 32 partners). The primary~     method of data collection will be face-to-face semi-structured interviews. These interviews~     will be audio-recorded.~   "
62105|NCT02753972|"~     Background: Mindfulness-based interventions may be effective in reducing the stress that may~     increase both obesity and inflammation.~      Purpose: The purpose of this study was to examine the effects of a mindful eating~     intervention on weight loss and health-related outcomes.~      Methods: Thirty-six obese, postmenopausal women were randomized to a six-week Mindful Eating~     and Living (MEAL) intervention or an active control group (CONT) consisting of nutritional~     counseling, goal setting, and group support. Weight, body mass index (BMI), waist-hip ratio~     (WHR), binge eating, interleukin-6 (IL-6) and C-reactive protein (CRP) were assessed at~     baseline and four follow-up periods up to one year.~      Results: Multilevel analyses showed that the MEAL group had reductions in weight, BMI, WHR,~     binge eating, IL-6, and CRP; the CONT group had reductions in weight, BMI, and binge eating.~     The reductions in binge eating, IL-6, and CRP were greater for the MEAL as compared with the~     CONT group.~      Conclusions: This study suggests that a mindfulness-based eating intervention may promote~     weight loss and reduce a variety of health-related risk factors in post-menopausal women who~     are obese.~   "
62106|NCT02753959|"~     Patients with NMD can suffer from a range of respiratory problems due to respiratory muscle~     weakness. Cough muscle weakness worsens secretion clearance from the airways, and increases~     the risk of infection. As a result, these patients often require chest physiotherapy or are~     supported with devices to aid clearance (such as mechanical insufflation-exsufflation) to~     reduce the risk of infection. Although evidence supports the use of these devices, the~     optimal technique or settings on the device are not clear.~      Electrical impedance tomography (EIT) is a new technology that involves wearing a belt of~     sensors around the chest that provides information on how well the lungs are being filled~     with air. It allows a non-invasive assessment of the effect of each secretion clearance~     technique on lung ventilation in real-time.~      This study aims to compare how well the lung is filled with air between three different~     techniques for secretion clearance (clearing mucus and phlegm from the airways), in order to~     determine which of the techniques is the most effective, in patients with NMD.~   "
62107|NCT02753946|"~     The purpose of the study is to demonstrate the safety and efficacy of ZTI-01 (IV fosfomycin)~     as non-inferior to piperacillin/tazobactam in overall success (clinical cure and~     microbiologic eradication) for the treatment of hospitalized patients with complicated~     urinary tract infections (cUTI) or acute pyelonephritis (AP).~   "
62108|NCT02753933|"~     This study aims to evaluate whether direct access from General Practitioners (GPs) to~     Magnetic Resonance Imaging (MRI) for patients with chronic headache decreases overall NHS~     costs and increases patient satisfaction compared to clinical practice with referral to~     Neurology Services.~   "
62109|NCT02753920|"~     Voiding difficulties are common after prolapse and incontinence surgeries. All patients after~     vaginal prolapse surgery must complete a voiding trial if they are to be discharged home~     without a catheter. Accepted protocols for voiding trials after prolapse and incontinence~     surgeries do not exist. The purpose of this study is to compare two different types of~     postoperative voiding trials to determine which leads to less postoperative issues, such as~     urinary retention requiring catheterization. You are being asked to participate because you~     are having a vaginal apex suspension surgery.~   "
62110|NCT02753907|"~     Self-reported healthy participants (n=150) aged 30-65 years with 18.5 kg/m^2 ≤ BMI < 30~     kg/m^2 were randomly assigned into three groups: a low linoleic acid (LA, 18:2n-6) group~     (n=50) replaced 10 mL soy oil with one apple; a medium LA group (control group, n=50)~     maintained usual food intake; a high LA group (n=50) reduced 1/3 cup of cooked refined rice~     and consumed 9.9g of soy oil capsules daily as a supplement. Plasma fatty acids and~     lipoprotein-associated phospholipase A2 (Lp-PLA2) activity were measured at baseline and 8~     week alongside other cardiovascular disease risk factors.~   "
62111|NCT02753894|"~     The objective of this study is to examine the clinical dose range of ASP1585 based on the~     efficacy, safety, and feasibility of treatment in chronic kidney disease patients on~     hemodialysis with hyperphosphatemia.~   "
62112|NCT02753881|"~     Patients with primary and secondary liver cancer may participate in this study. The purpose~     is to perform an analysis of the effects of doxorubicin and its metabolite doxorubicinol on~     the body (doxorubicin pharmacokinetics ) after conventional transarterial chemoembolization~     (cTACE). cTACE is a procedure in which chemotherapy drugs are injected, followed by an~     injection of small beads to block the tumor-feeding arteries. Doxorubicin is a~     chemotherapeutic agent used in the cTACE procedure. This study will examine doxorubicin~     pharmacokinetics in patients who: 1) receive whole liver cTACE; and 2) receive~     super-selective CTACE (i.e., delivered in close proximity to the tumor).~   "
62113|NCT02753868|"~     The purpose of this study is to examine the effect of cycling at mild to moderate intensity~     during hemodialysis treatment on cardiovascular function in a crossover design.~   "
62114|NCT02753855|"~     The purpose of this study is to characterize plasma and urinary concentrations of telavancin~     following intravenous administration of a single dose of telavancin in healthy subjects who~     are normal weight, overweight, and obese.~   "
62115|NCT02753842|"~     This study will enroll 252 men who have sex with men (MSM) and 252 men who have sex with~     women (MSW) in a double-blind, three-way randomized crossover trial with conditions of~     fitted, thin, and standard condoms. The study will provide fitted condoms in 56 sizes based~     on combinations of length (approximately 10 mm increments) and circumference (approximately 2~     mm increments), with user-determined size based on a paper template measurement instrument.~      Participants will be randomly assigned to the sequence in which the crossover intervention~     conditions (fitted, thin, and standard condoms) occur, with five study condoms provided for~     each condition. Participants will attend at least four, and up to seven, biweekly study~     visits.~   "
62116|NCT02753829|"~     The sample of this randomized controlled trial was obtained in the Cardiovascular Prevention~     and Rehabilitation Unit, of the Hospital Centre of Porto, Santo Antonio General Hospital. The~     target population was individuals who have completed the training phase of cardiovascular~     rehabilitation program, volunteers and referenced by the responsible for the service.~      This study has as main objective to analyze the influence of a specific exercise program,~     maintenance phase of cardiovascular rehabilitation , in home care context, for a period of 6~     months, using a virtual format (computer and Kinect) or a conventional format (paper manual)~     in subjects with coronary artery disease. It was intended to analyze the immediate effect of~     exercise program on body composition and food consumption patterns, functional muscle~     strength of lower limb, level of physical activity: total volume of activity as well as the~     profile of this intensity, kyphotic index, balance, cognitive and executive function, as well~     as in the quality of life.~      The aim is also to examine the effects, approximately 3 months after the end of the exercise~     program, in the lipid profile, the level of physical activity: total volume of activity as~     well as the profile of this intensity and cardiovascular fitness: maximum double product ;~     metabolic equivalents; and proof and recovery time.~      The individuals were distributed at random, every 3 individuals, using the capabilities of~     Microsoft Excel 2010 RANDBETWEEN command, by three groups: the experimental group 1- a~     cardiovascular rehabilitation program, in home care context, using a computer and Kinect,~     virtual format, the experimental group 2- in cardiovascular rehabilitation program, in home~     care context, using a paper-based manual, conventional format, and control group-only subject~     to education for cardiovascular risk factors.~      The program defined 3 training sessions per week. The rehabilitation program was oriented by~     the guidelines for exercise prescription.~      Participants perform the a program of specific exercises independently and individually, with~     remote supervision, using communication (phone, email, etc.) and a routine scheduled~     individual meetings.~   "
62117|NCT02753816|"~     Major surgery can result in blood loss that can require a blood transfusion during and/or~     after surgery. Tranexamic acid (TXA) is a medication that was first introduced in the 1960's~     as a treatment for heavy menstrual bleeding. Over the past 20 years, it has been used and~     studied in patients undergoing open-heart surgery, liver transplantation, and urologic~     surgery. Investigators believe tranexamic acid may possibly decrease bleeding related to~     major burn surgery, resulting in reduced blood loss, lower blood transfusion rates, and~     possibly decreased hospital costs related to your stay.~      In this study, prior to each surgical procedure to treat the participants burn injury, the~     participant will receive either the drug tranexamic acid or placebo. The placebo is a liquid~     that looks like the tranexamic acid medicine, but does not have any active ingredient in it.~     In this study, both the tranexamic acid and the placebo are considered research.~   "
62118|NCT02753803|"~     A randomized, open-label, multiple dosing, three-way crossover clinical trial to investigate~     the pharmacokinetic/pharmacodynamic drug-drug interaction of evogliptin 5 mg and pioglitazone~     30 mg after oral administration in healthy male subjects~   "
62119|NCT02753790|"~     Some cancers can spread, or metastasize, to the brain. When they do, treatment often involves~     surgery and/or radiation. Optimal treatment of brain metastases would maximize disease~     control and minimize toxicity (or side effects), and improve the quality of life of patients.~     A common type of radiation used for brain metastases is called whole brain radiation, which~     treats not just the cancer that can be seen on scans (i.e., gross disease), but the smaller~     sites of cancer that may not be visible (i.e. subclinical disease). Fractionation is used to~     describe repetitive treatments in which small doses (fractions) of a total planned dose are~     given at separate clinic visits. The most common dosing regimen is 30 Gray (Gy), using 3 Gy~     per fraction over 10 fractions. Previous studies have suggested that using intensity~     modulated radiation therapy (IMRT) may be a safer way to deliver higher doses to gross~     disease and lower doses to the rest of the brain that may contain subclinical disease. This~     approach may spare the rest of the brain from radiation complications and side effects.~      The goal of this study is to determine whether using IMRT to treat brain metastases is more~     effective than current standard whole brain radiation in controlling gross disease and~     whether patient quality of life and hair loss is improved compared to previous studies using~     whole brain radiation.~   "
62120|NCT02753777|"~     Pemphigus and bullous pemphigoid (BP) are severe autoimmune blistering diseases (AIBD) that~     pose a critical need for new therapeutic approaches. Clinical trials in pemphigus and BP will~     require the availability of validated disease severity measures that can be used to define~     primary outcomes.~   "
62121|NCT02753764|"~     This is a double-blind, placebo controlled 4 week crossover study to investigate the efficacy~     and safety of AZD7624 (an inhaled p38 inhibitor) in corticosteroid resistant (CR) asthmatics.~     For the purpose of this study 10 symptomatic CR asthma patients with a FEV1% predicted <80%~     and normal bronchodilator response, 10 CS asthmatics and 10 healthy controls will be~     recruited.~   "
62122|NCT02753751|"~     This study will enroll hospitalized adults with acute kidney injury (AKI) and randomize them~     to usual care versus an electronic alert coupled to a best practices order set.~   "
62134|NCT02753595|"~     The primary objective for the study is as follows:~      For the Phase 1b - to determine safety tolerability and recommended Phase 2 dose (RP2D) of~     eribulin mesylate in combination with PEGylated recombinant human hyaluronidase (PEGPH20) in~     participants with Human Epidermal Growth Factor Receptor (HER2)-negative metastatic breast~     cancer (MBC) previously treated with up to two lines of systemic anticancer therapy in the~     metastatic setting.~      For the Phase 2 - to evaluate objective response rate (ORR) of eribulin mesylate in~     combination with PEGPH20 in participants with HER2-negative, High-Hyaluronan (HA)-high, MBC~     previously treated with up to 2 lines of systemic anticancer therapy in the metastatic~     setting.~   "
62135|NCT02753582|"~     The primary objective is to determine the effect of SOD enzyme on frailty and health related~     quality of life among Indonesian pre-frail elderly.~      The secondary objective is to determine the effect of SOD enzyme on anti-oxidant status,~     morbidity, and hospitalization among Indonesian pre-frail elderly.~      The study hypothesis:~        1. SOD enzyme can improve frailty status and health related quality of life among~          Indonesian pre-frail elderly.~        2. SOD enzyme can increase anti-oxidant serum status among Indonesian pre-frail elderly.~        3. SOD enzyme can decrease morbidity among Indonesian pre-frail elderly.~        4. SOD enzyme can decrease hospitalization events among Indonesian pre-frail elderly.~   "
62123|NCT02753738|"~     Background:~      Conclusive evidence states that the serotonergic system mediates neuroplasticity from early~     embryonic development until brain maturation in adulthood. This study aims to demonstrate~     that selective serotonin reuptake inhibitors (SSRIs) enhance learning-dependent~     neuroplasticity in vivo, hereby contributing to the investigators understanding of the~     mechanism of action of therapy with SSRIs.~      Objectives:~        1. To prove a positive influence of SSRIs on structural remodeling during learning,~          reflected by enhancements of gray and white matter microstructure, connectivity and~          functionality in brain regions involved in learning processes.~        2. To show that this effect is topologically specific, i.e. that enhancements of plasticity~          markers are found in different regions depending on their involvement during the~          performance of specific learning tasks.~      Study design:~      Randomized, double-blind, placebo-controlled, longitudinal mono-center study. 80 healthy~     subjects will undergo three MRI scanning sessions: 1. baseline, at study entry, 2. after 3~     weeks of facial/emotional (n=40) or Chinese character-meaning learning (n=40) and 3. after 3~     weeks learning of new associations under administration of an SSRI or placebo.~      Methods:~      MRI measurements will be performed on a 3 Tesla PRISMA MAGNETOM MR scanner. Changes in gray~     matter microstructure will be assessed using high-resolution structural MRI and analyzed with~     voxel-based morphometry (VBM). Diffusion tensor imaging (DTI) enables non-invasive~     investigation of neuroplasticity in the human brain based on the reduction in mean~     diffusivity associated with swelling of astrocytes after increased synaptic activity.~     Resting-state functional MRI (fMRI) will allow for the measurement of changes in functional~     coupling between brain regions, and fMRI during tasks will assess differential activity in~     brain regions during learning.~      Relevance and implications:~      This study aims to provide evidence that SSRIs facilitate cytoarchitectonical restructuring.~     In addition to expanding the investigators current knowledge on the trophic effects of SSRIs,~     the results of this study will also elucidate interactions between the serotonergic system~     and changes to neuronal networks during learning as well as their behavioral consequences. By~     probing the neurobiological correlates of the antidepressant and anti-anxiety effects of~     SSRIs, this study will provide a rationale for targeted interventions that harness the~     neuroplasticity enhancing properties of SSRIs to facilitate therapeutic processes.~   "
62124|NCT02753725|"~     This study will be a randomized double blind placebo controlled clinical trial among children~     undergoing adeno-tonsillectomy in KNH. The intervention arm will comprise Fentanyl given at a~     dose of 1ug/while the placebo arm will be given normal saline at a volume equivalent to~     Fentanyl dose, treatment will be administered approximately ten minutes to the end of surgery~     determined by the time when the mouth gag will be removed. The main outcome will be incidence~     of ED at the recovery room using Watcha scale and secondary outcomes will be delay in~     emergence time from anaesthesia and effectiveness of fentanyl in preventing ED.~   "
62125|NCT02753712|"~     The purpose of this study is to demonstrate improvement of peripheral airway resistance~     (R5-R20) from baseline with fluticasone/formoterol breath actuated inhaler (BAI).~   "
62126|NCT02753699|"~     The purpose of this study is to follow-up with participants from feeder studies who achieved~     sustained virologic response (SVR) over 24 hours posttreatment (SVR24), to assess durability~     of SVR, and to assess the changes in liver disease, development of hepatocellular carcinoma~     and post-treatment safety over time.~      Participants enter this study from feeder studies CDEB025A2210 (NCT01183169), CDEB025A2301~     (NCT01318694), and CDEB025A2211 (NCT01215643). They return to the site for up to 48 weeks~     with a maximum of 3 visits. No treatment is involved.~   "
62127|NCT02753686|"~     Although randomized controlled trials (RCTs) provide evidence of efficacy, generalization of~     these results to patients in the real-world setting is challenging, given RCTs are conducted~     in highly selected patient populations.~      An understanding of the effectiveness and safety of approved cancer therapies in routine~     clinical practice is essential in order to optimize the management of these patients and to~     identify treatment and safety gaps.~      This is the first Canadian study to describe real-world treatment patterns/sequencing,~     effectiveness and safety for postmenopausal HR+ HER2- advanced breast cancer patients. This~     registry incorporates an observational prospective cohort design and will enroll 320~     postmenopausal HR+ HER2- advanced breast cancer women that have been previously exposed to~     non-steroidal aromatase inhibitor (NSAI) therapy being treated with endocrine therapy (ET) or~     ET in combination with targeted therapy (TT).~   "
62128|NCT02753673|"~     The purpose of this study is to develop a questionnaire to measure patient expectations of~     breast-conserving therapy (breast-conserving surgery and radiation). This questionnaire will~     assist both surgeons and patients by helping provide valuable information to patients about~     what to expect during and after surgery.~   "
62129|NCT02753660|"~     The aim of this study was to compare the successful spinal puncture among patients with~     pendant position in comparison with those who used traditional sitting position for caesarean~     section.~   "
62130|NCT02753647|"~     This is a prospective, single-arm, open-label phase II study of Chidamide in combination with~     R-CHOP in the treatment of de novo, elderly, high-risk diffuse large B cell lymphoma~     patients.~   "
62131|NCT02753634|"~     Osteoarthritis (OA) is a growing burden in an aging society. There are few proven treatments~     and hence disability contributes to poor quality of life and direct/indirect costs to~     society. OA symptoms include both increased pain and reduced mobility. Strength training and~     aerobic exercise has been shown to improve symptoms in OA; however, the impact of targeted~     mobility and balance training in patients with osteoarthritis is unclear. The investigators~     propose a novel, low-impact exercise modality that improves balance and gait. The results of~     this research project should improve patient options and improve knowledge in OA management.~   "
62132|NCT02753621|"~     The overall objective of this study is to observe the effect of group Vocal performance~     training and performance experience on patients' reported symptoms and quality of life. The~     effectiveness of PD medications varies significantly in different patients depending on their~     symptoms. By using music-based interventions to improve symptoms that may be inadequately~     treated by medications, the investigators hope to improve quality of life in PD patients.~     Parkinsonics: A controlled study of group singing for quality of life and voice outcomes in~     Parkinson disease (PD) is a controlled crossover behavioral intervention study of once~     weekly choral classes for patients with idiopathic PD (progressing toward a group~     performance) and once weekly discussion/support group meetings.~   "
62133|NCT02753608|"~     The study goal consists in the sequential collection of exhaled breath condensates (EBC) from~     patients receiving invasive ventilation. Subsequent Raman spectroscopy aims at the~     identification of putative biomarkers that could enable rapid early distinction of~     Ventilator-associated pneumonia.~   "
62136|NCT02753569|"~     This feasibility study will aim to assess the potential for functional imaging biomarkers~     (18FDG PET-CT and DW-MRI) to differentiate immunotherapy induced inflammation, indicative of~     response from non-response in patients with stage IV non-small cell lung cancer (NSCLC).~   "
62232|NCT02752321|"~     The purpose of this study is to determine whether the addition of a mobile or web based~     multimedia discharge application (eDischarge) to the discharge process is effective in~     improving patient experience, engagement, and clinical outcomes in the early post discharge~     period.~   "
62137|NCT02753556|"~     ScreenFlow is a chronic obstructive pulmonary disease (COPD) screening tool currently being~     studied and iteratively developed that incorporates a questionnaire administered on a tablet~     and data from a digital peak flow meter to calculate a risk score to identify the risk of~     developing moderate-to-severe COPD for the participant. The purpose of this study is to~     assess the usability of ScreenFlow deployed as a free-standing kiosk and observe where users~     encounter trouble navigating the system. The kiosk will be situated in a public area of a~     hospital where passersby can approach and fill out a ScreenFlow survey if they meet the~     eligibility criteria. A subset of participants will be asked to participate in a follow-up~     questionnaire about their experience using the system and about any follow-up action they may~     have taken caused by their results from the ScreenFlow screening.~   "
62138|NCT02753543|"~     This is a single arm, prospective trial to evaluate the efficacy and safety of Chidamide in~     combination with previous chemotherapy in peripheral T cell lymphoma patients who did not~     achieve complete response after 3 cycles of chemotherapy in interim evaluation.~   "
62139|NCT02753530|"~     Funding Source - FDA OOPD. The purpose of this study is to evaluate the safety and efficacy~     of the study drug, Arimoclomol in IBM patients.~   "
62140|NCT02753517|"~     Extended hepatectomies of 4 or more segments are complicated by high rates of morbidity and~     mortality, mainly related to hepatic liver failure. Nowadays, preoperative assessment of the~     future remnant liver is just performed through its volumetric measurement by computed~     tomography. Nevertheless, this volumetric assessment does not reflect the hepatocellular~     function of the future remnant liver that can be disturbed in case of vascular and/or biliary~     obstruction, chemotherapy-induced liver injuries or steatosis in overweight patients.~     Literature data (albeit originating from a single centre in Europe) have suggested that~     (99m)Tc-mebrofenin hepatobiliary scintigraphy could be useful in evaluating the function of~     the future remnant liver. The aim of this prospective multicentric study is to determine the~     predictive value of hepatobiliary scintigraphy in assessing the risk of postoperative liver~     failure of extended hepatectomies of 4 or more segments in noncirrhotic liver.~   "
62141|NCT02753504|"~     The purpose of this study is to investigate the safety/tolerability and~     pharmacokinetics/pharmacodynamics of CKD-519~   "
62142|NCT02753491|"~     This study designed for primary care practionars for chronic care in primary care. A new~     model of motivational short interview used for intervention. The aim of this study is to~     develop diet and exercise regimens in type 2 diabetic patients.~   "
62143|NCT02753478|"~     Hypothermia may reduce infarct size in patients with acute myocardial infarction if provided~     before reperfusion. Human studies using systemic cooling methods failed to show a reduction~     in infarction size. The use of selective intracoronary hypothermia may overcome the problems~     of systemic cooling.~      The hypothesis of this study is that in patients with acute myocardial infarction, the~     induction of intracoronary hypothermia is safe and feasible.~   "
62144|NCT02753465|"~     During surgery for rectal cancer, there is considerable controversy regarding the optimal~     level of ligation of the inferior mesenteric artery. Several studies have demonstrated the~     benefit of high ligation of the inferior mesenteric artery for the rectal cancer in order to~     achieve block dissection of lymph node metastases along the root of the inferior mesenteric~     artery. In contrast, other studies have shown a significant decrease in blood flow after~     inferior mesenteric artery clamping that may increase the risk of anastomotic ischemia and~     the long-term outcomes were not significantly different between high ligation of the inferior~     mesenteric artery and low ligation. So, a modified procedure was suggested to dissect fatty~     tissues and nodes in the angle between the inferior mesenteric artery and the left colic~     artery and the artery was ligated below the left colic artery. In the present clinical trial,~     the investigators perform laparoscopic surgery with this management strategy in rectal~     cancer. Thus, the goal of this study is to investigate the short-term and oncologic long-term~     outcomes associated with laparoscopic lymph node dissection around the inferior mesenteric~     artery with preservation of the left colic artery for rectal cancer.~   "
62145|NCT02753452|"~     In Canada, between 3.6% and 7.7% of children under 19 years old are thought to have a chronic~     health condition that results in disability or limits to activity. These young people have~     difficulty finding jobs, attending school, living independently, and forming relationships~     with other people. These poorer life outcomes are partly the result of a lack of life skills.~     Life skills include the ability to solve problems and set goals, which allows youth to deal~     with the demands of everyday life. Several children's treatment centres in Ontario offer~     short-term residential immersive life skills (RILS) programs to provide youth with these life~     skills to help them take on adult roles. RILS programs are very promising in terms of making~     a long-term difference in youths' lives because they provide a place where youth can learn by~     doing, working with peers and taking risks in a safe environment. However, we do not yet know~     how well skills that are learned in RILS programs are kept up as time passes or how well RILS~     programs support broader skills, such as the ability to make one's own choices.~      The proposed research will examine these issues and will ask the following questions:~        1. What opportunities are youth given when they participate in RILS programs? What specific~          strategies do RILS service providers use to support youth in learning life skills?;~        2. How do youth experience and perceive their participation in a RILS program, before,~          during and after they take part? What do their parents expect and experience in terms of~          their child's participation?; and~        3. What changes do youth experience, particularly in terms of their ability to make choices~          for themselves and their sense of being able to cope with things that come up in their~          lives? The study will involve youth from several treatment centres in Ontario over the~          next three years.~      Youth who are attending RILS programs will be compared with:~        1. youth who are similar to the RILS youth, but who are taking part in a life skills~          program that is not residential;~        2. youth who applied to a RILS program and were accepted, but who will take part in the~          program in a different year; and~        3. a group of youth who are similar to the RILS youth but who are not taking part in any~          life skills program.~      Youth will provide data at four time points: before the program starts, immediately after the~     program finishes, three months after the program is over and 12 months after the program is~     over.~   "
62146|NCT02753439|"~     A prospective study examining bilateral 3rd molar extraction, by a split mouth protocol the~     investigators augment unilaterally and compare periodontal parameters in between.~   "
62147|NCT02753426|"~     The goal of this trial is to evaluate whether subantimicrobial-dose of doxycycline (20mgBID)~     will affect serum and urine biomarkers of fibrosis in patients with pre-dialysis chronic~     kidney disease.~   "
62148|NCT02753413|"~     The purpose of this study is to assess the safety and reactogenicity of a single~     intramuscular dose of GSK Biologicals' investigational RSV vaccine, in healthy, non-pregnant~     women aged 18 to 45 years.~   "
62149|NCT02753400|"~     To evaluate the effects of oral emixustat hydrochloride (emixustat) on aqueous humor~     biomarkers associated with proliferative diabetic retinopathy (PDR) from baseline to week 12.~   "
62150|NCT02753387|"~     Surgical site infections are an important health indicator for hospitals and a significant~     medico-economic issue.~      The aim of the study is to assess the impact of chlorhexidine mouthwash performed before~     surgery on the bacterial colonization of the pharyngeal mucosa.~   "
62153|NCT02753348|"~     Copenhagen Baby Heart is an observational, cohort study of >30.000 children born in the~     Copenhagen area 2016-2018.~      Newborns are examined with echocardiography, electrocardiogram, measurements of oxygen~     saturation and analyses of umbilical cord blood.~      The main objectives of the baseline assessments in Copenhagen Baby Heart are to assess the~     prevalence of congenital and inherited heart disease unrecognized prenatally, to assess the~     yield of routine echocardiography shortly after birth and to establish reference values for~     echocardiography in Danish neonates.~      Prospective follow-up of the birth cohort is planned with the purpose to assess the life-long~     development of cardiovascular disease as well as other conditions and to study associations~     between both pre- and postnatal exposure and disease, including life style, environmental and~     genetic factors.~   "
62154|NCT02753335|"~     The intention of this trial is to investigate whether combined Graded Motor Imagery (GMI) and~     Desensitization (D) among patients with CRPS is clinically more effective than only D and to~     study changes in connectivity in the Default Mode Network before and after treatment.~   "
62155|NCT02753322|"~     Stroke is one of the most common chronic disabling conditions in Hong Kong. People after~     stroke may suffer from certain degree of physical impairment and disability. Resuming safe~     ambulation in the community appears to be a big challenge to them as it always involves the~     simultaneous performance of two or more tasks (dual task) such as walking and talking with~     someone, walking and recalling the shopping list etc. Numerous studies has demonstrated that~     the interference from dual tasks (dual task interference) may significantly impact the~     recovery of the functional walking. To date, the relevance of dual task walking to daily~     community is widely documented and the ability of managing dual task is therefore~     particularly important. Evidences supported that dual task training showed its promising~     effect on the balance and walking performance amongst people with neurological disorders,~     such as chronic stroke. In light of this, the introduction of dual task based balance and~     walking training into physiotherapy program for stroke patient may enhance the balance and~     walking performance and hence promote successful community ambulation. Yet, there is limited~     evidence on its effect in sub-acute stroke.~      Objective: To examine the effectiveness of a dual-task based balance and walking training~     program on performance and dual task interference in balance and walking ability, balance~     self-efficacy and incidence of falls in people with sub-acute stroke~   "
62156|NCT02753309|"~     This study is looking at the effects of Sirolimus (Rapamycin) on BCG-specific immunity during~     treatment of non-muscle invasive bladder cancer (NMIBC) with maintenance BCG.~   "
62157|NCT02753296|"~     The aim of this research study is to develop a patient decision aid (PDA), and evaluate~     whether its integration within oncology services enable cancer services to effectively~     support and provide evidence based resources for women's fertility preservation decisions,~     following a diagnosis of any cancer type.~   "
62158|NCT02753283|"~     The purpose of this research study is to find out if denosumab (Prolia®), an injection given~     in the arm under the skin every 6 months, works to treat bone loss and prevent it from~     worsening in older men and women (ages 65 and older) who have osteoporosis and reside in~     long-term care (LTC) facilities.~   "
62159|NCT02753270|"~     Foam sclerotherapy has been established as another option of treatment for varicose veins of~     the lower limbs. Its advantages are the application to patients with high surgical risk and~     immediate return to usual activities. Comparing to laser and radiofrequency, it has lower~     cost and is less painful. Nevertheless, it requires more re-interventions due to venous~     recanalization.~   "
62160|NCT02753257|"~     Valtari Bio has early proof of concept clinical data of a multi-omic peripheral blood~     biomarker profile that can be used to determine stroke from no stroke in the emergency~     setting. The objective of this observational cohort clinical study is to determine the~     clinical utility of this multi-omic biomarker profile.~      Primary Study Aims:~        1. The diagnostic tests characteristics of a multi-omic biomarker diagnostic for stroke~          (ischemic stroke, transient ischemic attack (TIA) and hemorrhagic stroke) versus no~          stroke (stroke mimic).~        2. The ability of a multi-omic biomarker profile to differentiate ischemic stroke from~          hemorrhagic stroke and TIA.~   "
62161|NCT02753244|"~     This study aims to assess the feasibility of Intendu Cognitive Motion-Based Videogames in~     Acquired Brain Injury (ABI) patients in inpatient treatment and in the community and to~     evaluate the effects of training on patients' cognitive performance~   "
62162|NCT02753231|"~     The HEPAFIT Study aims to examine whether a 6-months physical education program has benefits~     on hepatic metabolism and cardiovascular health as well as on selected physical fitness and~     mental health outcomes among adolescent overweight/obese from Bogota, Colombia.~   "
62163|NCT02753218|"~     The purpose of this study is to investigate the effects of multiple oral doses of LEO 32731~     on the pharmacokinetics of a single oral dose of the cytochrome P450 3A substrate midazolam~     in healthy male subjects.~   "
62164|NCT02753205|"~     Dexmedetomidine, might attenuate the sympathetic activation and contribute to stable~     hemodynamics. The investigator hypothesized that continuous infusion of dexmedetomidine~     during laparoscopic lower abdominal surgery, might help to attenuate the increment of~     intracranial pressure and the investigator would observe the optic nerve sheath diameter~     using ultrasonography.~   "
62175|NCT02753062|"~     This is an open-label, multi-center, prospective, single arm phase 2 trial of the combination~     of bendamustine and rituximab in patients with PTLD, monomorphic cluster of differentiation~     antigen 20(CD20) positive DLBCL. The investigators want to investigate the efficacy and~     safety of the combination of bendamustine and rituximab in patients with previously untreated~     PTLD, monomorphic CD20 (+) diffuse large B-cell lymphoma.~   "
62199|NCT02752750|"~     In this explorative longitudinal study 50 patients with Alzheimer's disease (AD) and 50~     age-matched control subjects will be recruited for their 2 years follow-ups and undergo~     extensive cognitive testing and quantitative 3 Tesla magnetic resonance imaging (MRI).~     Regional differences of susceptibility and R2* relaxation rates in deep gray matter and the~     neocortex will be evaluated in AD patients and controls and related to the patients´~     cognitive status at baseline.~   "
62200|NCT02752737|"~     Cryo AF Global Registry a prospective, global, multi-center, observational Post-Market~     Registry~   "
72500|NCT02617992|"~     The development of a standardised imaging protocol to detect post endoscopic mucosal~     resection (EMR) recurrence or residual adenoma through the comparison of biopsies of the post~     EMR scar with endoscopic findings.~   "
62165|NCT02753192|"~     Parkinson's disease (PD) affects between 1% and 2% of the world's population aged 60 and~     older; in Europe the prevalence is around 150 PD patients per 100,000 individuals. PD is~     classically characterized by a symptomatic triad that includes rest tremor, akinesia and~     hypertonia and although the motor expression of the symptoms involves mainly the limbs, the~     muscles implicated in speech production are also subject to specific dysfunctions. Motor~     speech disorders, so-called dysarthria, can thus be developed by PD patients. The main~     objective of our project is to evaluate the physiological parameters (acoustics), perceptual~     markers (intelligibility) and psychosocial impact of dysarthric speech in PD, in the context~     of language (French vs. Portuguese) modulations. Acoustic parameters are expected to be~     physiologically-based, linked with the motoric aspects of dysarthric speech. The same degree~     of impairment of such parameters should be associated with the pathology and be present~     universally in all patients, even if they speak different languages; that should be also the~     case of prosodic markers, whereas impairment of speech intelligibility may participate to the~     psychosocial impact in communication alteration.~      PD patients will be enrolled in the study in Aix-en-Provence (N = 60) and Lisbon (N = 60).~     Their global motor disability will be assessed with dedicated clinical rating scales, without~     (off) and with (on) pharmacological treatment. Two groups of 60 healthy age-matched~     volunteers will provide the normal reference for between-group comparisons. Along with the~     off and on medication clinical examinations, several speech tasks will be recorded. Moreover,~     speech organ functions will also be assessed during the same examination. The psychosocial~     impact of dysarthria will be evaluated via self-questionnaires; it will be analysed a~     posteriori, as well as the speech intelligibility evaluation, and both will strengthen the~     overall speech assessments. This global investigation will represent a unique opportunity to~     provide the most precise and reliable description of PD patients' speech and its impacts on~     intelligibility and quality of life. Challenging and interdisciplinary aspects are combined~     in our project, which original cross-linguistic approach involves an international~     collaboration definitely new in the field of motor speech disorders.~   "
62166|NCT02753179|"~     Patients with chronic bilateral vestibular hypofunction may suffer from a visual instability~     during head movement called oscillopsia. Visual consequence of vestibular deficit can lead to~     a severe impairment of their quality of life. However, correcting saccades during rapid head~     movement, called covert-saccades, have been more recently identified. These saccades, which~     occur during the head movement in patients with vestibular hypofunction, present a very short~     latency. They could compensate for the lack of vestibular-ocular reflex and greatly decrease~     oscillopsia and visual impairment. The objective of this study is to evaluate the potential~     functional benefice of these compensatory movements in a population of 20 patients with~     chronic bilateral areflexia, in a cross-sectional study.~   "
62167|NCT02753166|"~     To determine if a single dose of dexamethasone (5 mg) administered in the first 12 hours~     following a potentially traumatic event alters a) cortisol and FKBP5 RNA the next day in the~     periphery measured in saliva; b) FKBP5 methylation by 1 month; c) executive functioning and~     emotion regulation functioning; d) psychophysiological (heart rate, respiration, skin~     conductance) in response cued reminders of the trauma; e) enhances the likelihood of~     remission of PTSD symptom severity.~   "
62168|NCT02753153|"~     This study aims at assessing the hard and soft tissues remodelling of the alveolar crest~     after extraction socket managements in the aesthetic areas:~        -  3D radiographic evaluation (CT scan) was performed post extraction and 3 months after at~          the time of implant placement. (Outcomes 1: Hard tissues analyses )~        -  Impressions, models and 3D analyses of the treated area allowed studying external soft~          tissue remodeling at different time points after extraction. (Outcomes 2: Soft tissues~          analyses )~   "
62169|NCT02753140|"~     Verify the effect and the incidence of oral mucositis of concurrent chemoradiotherapy in~     locally advanced squamous cell carcinoma of the head and neck versus concomitant cetuximab~     with radiotherapy after neoadjuvant chemotherapy.~      The predictive effect of Apurinic/apyrimidinic endonuclease 1(APE1)/ Ref-1 protein and~     Apurinic/apyrimidinic endonuclease 1(APE1)/Ref-1 antibody on oral mucositis.~   "
62170|NCT02753127|"~     This is an international multi-center, prospective, open-label, randomized phase 3 trial of~     the cancer stem cell pathway inhibitor napabucasin plus standard bi-weekly FOLFIRI versus~     standard bi-weekly FOLFIRI in patients with previously treated metastatic colorectal cancer~     (CRC).~   "
62171|NCT02753114|"~     Acute painful conditions make-up a large proportion of pre-hospital transports in British~     Columbia (BC) yet Basic Life Support (BLS) paramedics have limited options to provide~     analgesia and therefore adequate and timely pain relief is often significantly delayed.~      Inhaled nitrous oxide is commonly used as a pre-hospital analgesic and is considered usual~     care for pre-hospital providers in BC, but its utility in severe pain is uncertain.~     Moreover, nitrous oxide is limited in its effectiveness by a short duration of action,~     nausea, vomiting, and the necessity for patient cooperation.~      IN Ketamine has been shown to provide rapid, easily-administered, and well-tolerated~     analgesia in many settings. The investigators believe that the addition of IN ketamine to~     usual care with nitrous oxide inhalation for adults experiencing moderate to severe intensity~     acute pain in the pre-hospital setting will result in improved pain severity, improved~     patient-reported comfort, and improved patient satisfaction.~   "
62172|NCT02753101|"~     Chronic pain can result from injured or inflamed nerves, as occurs in people suffering from~     sciatica and CRPS. These nerve injuries or regions of nerve irritation are often the cause of~     pain in these conditions, but the current diagnostic tools are limited in pinpointing the~     area of origin. Several studies have implicated involvement of sigma-1 receptors in the~     generation and perpetuation of chronic pain conditions, others are investigating anti sigma-1~     receptor drugs for the treatment of chronic pain. Using the sigma-1 receptor (S1R) detector~     and experimental radiotracer [18F]FTC-146 and positron emission tomography/magnetic resonance~     imaging (PET/MRI) scanner, the researchers may potentially identify the source of pain~     generation in patients suffering from complex regional pain syndrome (CRPS) and chronic~     sciatica. The ultimate goal is to assist in the optimization of pain treatment regimens using~     an [18F]FTC-146 PET/MRI scan.~      The study is not designed to induce any physiological/pharmacological effect.~   "
62173|NCT02753088|"~     The objective of the clinical study of the medicinal product for medical use: to compare~     efficacy and safety of the generic drug BCD-063 and Copaxone®-Teva in patients with~     relapsing-remitting multiple sclerosis.~      Period of the clinical study of the medicinal product for medical use: from June 10, 2013 to~     March 23, 2016.~      Number of patients, involved into the study of the medicinal product for medical use: 158~     patients.~   "
62174|NCT02753075|"~     This study will investigate the longitudinal efficacy of two experimental oral rinses, one~     containing 1.5% weight/weight (w/w) dipotassium oxalate monohydride (KOX) /0 Parts per~     Million (ppm fluoride) and the other 2.0% w/w KOX /45ppm fluoride, for the relief of dentinal~     hypersensitivity (DH), compared to a placebo oral rinse, when used as an adjunct to twice~     daily brushing with a standard fluoride toothpaste.~   "
62176|NCT02753049|"~     This Mentored Patient-Oriented Research Career Development Award - (K23) seeks to provide the~     advanced knowledge, skills, and experience for the candidate's career transition to an~     independent nurse scientist. Her long term goal is to become a leading nurse scientist in~     designing, implementing, and evaluating technology supported behavioral interventions~     targeted for improved disease self-management (i.e. medication adherence, retention in care)~     among human immunodeficiency virus (HIV)-infected, ethnic minority adolescents and young~     adults. With an extensive background in pediatric HIV nursing and completed NIH funded pre~     and post-doctoral interdisciplinary research traineeships, the candidate has begun to develop~     the knowledge-base and skills necessary for this goal.~      This award details a 3-year scope of mentored career development through which she will gain~     the foundation for future research endeavors. Specifically, the goals of this proposal are~     to: 1) conduct a novel research project under the mentorship of an interdisciplinary team of~     expert researchers; 2) acquire expertise in health informatics for implementation of~     technology supported behavioral interventions, health disparities, and advanced qualitative~     and mixed methods design and analysis through firsthand experience, didactic interactions~     with mentors, and graduate level coursework; 3) build a network of colleagues and~     collaborators within New York University and elsewhere through this research and~     participation at national and international meetings; and 4) prepare and submit a federal~     research grant (R-21) based upon the skills and findings from this award period.~      The specific research project through which she will accomplish these goals is a proof of~     concept study, Adherence Connection for Counseling, Education, and Support (ACCESS), and~     addresses the challenge of adherence to antiretroviral treatment among HIV-infected~     adolescents and young adults. A mixed method design is proposed and the specific aims are to:~     1) Characterize the feasibility and acceptability of a peer led, mHealth cognitive behavioral~     intervention delivered via remote videoconferencing using smartphones; 2) Obtain initial~     estimates of the biobehavioral impact of ACCESS on HIV virologic outcomes and self-reported~     ART adherence, beliefs and knowledge about antiretroviral treatment, adherence self-efficacy,~     and healthcare utilization (retention in HIV care). In summary, the ACCESS adherence~     intervention is consistent with the National Institute of Nursing Research (NINR) call for~     the development of novel interventions to deliver personalized care and real-time health~     information for patients.~   "
62177|NCT02753036|"~     Neurotoxic phenomena are among the most common and difficult to treat side effects of~     chemotherapy. The development of chemotherapy induced peripheral neuropathy (CIPN) is a~     well-recognized adverse reaction in the peripheral nervous system. Side effects of~     chemotherapy in the central nervous system, however, particularly changes of cognitive~     function (in non-medical literature referred to as chemobrain) are diffuse and difficult to~     attribute to individual cytostatic drugs. The primary purpose of this study is to assess~     cognitive function in patients with ovarian and breast cancer before and after systemic~     chemotherapy with paclitaxel with standardized neuropsychological tests and compare the~     outcome to patients with benign gynecological tumors and breast cancer without chemotherapy~     treatment, respectively. Secondary parameters include the assessment of olfactory function,~     total neuropathy score and cytokine profiles.~   "
62178|NCT02753023|"~     Critical patients in emergency room are seriously situations that need quickly diagnosis and~     treatment. Different predictors of prognosis can be related with mortality and morbidity~     in-hospital and in long-term. In Brazil, this kind of registry is not available. The aim of~     the study is analysis and report data about critical patients in Emergency Departments over~     all country, showing demographic, clinical and prognosis data about that in Brazil.~   "
62179|NCT02753010|"~     The gastric emptying of 400 ml 12.6% carbohydrate rich drink is investigated in elderly~     women, age 75-100, with acute hip fracture. The emptying time will be assessed by the~     paracetamol absorption technique, and lag phase and gastric half-emptying time compared with~     two gender-matched reference groups: elective hip replacement patients, age 45-71, and~     healthy volunteers, age 28-55.~   "
62180|NCT02752997|"~     Patients admitted for heart failure that are provided discharge medication services by a~     pharmacist are less likely to be readmitted within 30 days of primary admission.~   "
62181|NCT02752984|"~     Deep Vein Thrombosis (DVT) is one of the most important complications after Peripherally~     Inserted Central Catheter (PICC) insertion. This study goals are to understand when and why~     DVT develops.~   "
62182|NCT02752971|"~     The infiltration of the surgical wound is an effective strategy for postoperative analgesia.~     Nonsteroidal antiinflammatories are useful in this way.~      Objective: To compare the analgesic effectiveness of diclofenac sodium, bupivacaine or~     bupivacaine plus diclofenac sodium infiltrating wound appendectomies.~      Method: Comparative, double blind, American Society Anesthesiologist classification~     I-II,18-65años. Group 1 (Bupivacaine n = 14), Group 2 (Diclofenac Sodium n = 14), Group 3~     (Bupivacaine + Diclofenac Sodium n = 15). Pain at rest and dynamic, rescue analgesic~     consumption in Post Anesthesia Care Unit (PACU) and 24 hours after surgery were evaluated.~   "
62183|NCT02752958|"~     This multicentre, non-comparative design study will monitor the impact of long term~     management of DH with daily use of a sensitivity toothpaste on the quality of life of a~     population of sensitivity sufferers. Changes in oral health related quality of life will be~     monitored using the Dentine Hypersensitivity Experience Questionnaire (DHEQ). The study will~     be conducted in participants in good general health, with pre-existing self-reported and~     clinically diagnosed tooth sensitivity at screening.~   "
62184|NCT02752945|"~     This is a feasibility trial designed to test the feasibility and acceptability of a one-day~     Cognitive Behavioural Therapy (CBT) workshop intervention (DISCOVER) for young people aged~     between 15-18 years, who are on local child and adolescent mental health services (CAMHS)~     waiting lists, awaiting treatment for difficulties with anxiety and/or depression.~     Participants will be randomised to receive either the DISCOVER workshop (in addition usual~     care) or to continue usual care.~   "
62185|NCT02752932|"~     Primary objectives:~        1. Evaluate the feasibility of rapidly accruing 30 participants with recurrent metastatic~          head and neck squamous cell carcinoma for the development of patient derived xenographs~          (PDX) from fresh, real time biopsies in which sensitivity to < 4 Ontario funded~          chemotherapeutic regimen will be tested. Written feedback to the primary oncologist will~          be provided.~        2. There is also a curative intent cohort of 30 participants undergoing surgical resection~          with curative intent. These PDX models will undergo exome sequencing with written~          feedback.~        3. Feasibility in both surgical and recurrent cohorts will be a measure of i) engraftment~          rate, ii) patient status at the time of drug testing completion and iii) rate of~          accrual.~   "
62186|NCT02752919|"~     The study involves a single dose of galunisertib taken by mouth by Japanese participants and~     non-Japanese participants. The study will evaluate the relationship between the effect of the~     study drug on the electrical activity of the heart, as measured by electrocardiogram (ECG)~     and how much of the study drug gets into the blood stream and how long it takes the body to~     remove it. Ths study will last about 42 days for each participant.~   "
62214|NCT02752555|"~     This study is the first to evaluate the effect of oral supplementation with antioxidants~     combined with lifestyle modification for severe male factor partner of couples undergoing~     ICSI.~   "
62187|NCT02752906|"~     The aim of the study is to describe the safety and antibody response to revaccination with~     MenACYW conjugate vaccine in persons who received their first quadrivalent meningococcal~     conjugate vaccine dose at ≥ 10 years of age.~      Primary Objective:~        -  To demonstrate the non-inferiority of the vaccine seroresponse of meningococcal~          serogroups A, C, Y, and W following the administration of a booster dose of MenACYW~          conjugate vaccine compared to those observed following the administration of a booster~          dose of a licensed Meningococcal Conjugate Vaccine (MCV4) in subjects who were first~          vaccinated with 1 dose of MCV4, 4 to 10 years before the booster dose.~      Secondary Objectives:~        -  To evaluate the vaccine seroresponse of meningococcal serogroups A, C, Y, and W measured~          using human serum bactericidal assay (hSBA) in serum specimens collected 6 days after~          vaccination in a subset of subjects~        -  To evaluate the antibody responses (geometric mean titers) to serogroups A, C, Y, and W~          measured using hSBA on Day 0 (pre-vaccination) and Day 30 after vaccination~      Observational Objectives:~        -  To describe the antibody titers against meningococcal serogroups A, C, Y, and W measured~          by hSBA assessed at Day 0, Day 6, and Day 30 days after vaccination~        -  To describe the safety profile of MenACYW conjugate vaccine compared to that of a~          licensed MCV4 after booster vaccination.~   "
62188|NCT02752893|"~     The investigators will establish a platform at Dartmouth-Hitchcock Medical Center to generate~     novel models of estrogen receptor alpha-positive (ER+), human epidermal growth factor~     receptor 2-negative (HER2-) breast cancer, which will be used for research studies to develop~     novel treatment strategies and dissect signaling pathways underlying drug sensitivity and~     resistance.~   "
62189|NCT02752880|"~     Type 2 diabetes mellitus is a chronic metabolic disease that seriously affects patients~     worldwide, and it is always among the top 10 causes of death in Taiwan. To date, still many~     patients who take more than three kinds of oral hypoglycemic agents could not effectively~     control their glycohemoglobin levels in clinics. Hypoglycemia as well as weight gain are~     common side effect with insulin therapy, and many patients in Taiwan are not willing to~     receive insulin injection. It is common for diabetic patients treated with Chinese herbal~     medicine in China currently, and some therapeutic effects have been published in~     international journals. In this study, we will evaluate whether Chinese herbal medicine, YH1,~     enhances the glycemic control and is safe as add-on medication in poorly controlled type 2~     diabetes patients.~      A total of 80 poorly controlled type 2 diabetes patients with glycohemoglobin ≥ 7% from~     Endocrinology and Metabolism clinics or Internal Chinese Medicine clinics will be enrolled in~     this randomized double-blind placebo-controlled trial. Subjects will be randomly assigned to~     receive either YH1 (6 g) or the placebo three times per day for 12 consecutive weeks. All~     subjects in both groups will also continuously receive their oral hypoglycemic agents without~     any dose or medicine change. During this 12-week period, the glycohemoglobin, fasting plasma~     glucose, 2h postprandial glucose, waist circumference, body weight, and body mass index will~     be assessed. In addition, insulin resistance, β -cell function, lipid profile, liver and~     renal function will also be evaluated. Independent statisticians will perform the data~     analysis at the end of the trial.~   "
62190|NCT02752867|"~     The purpose of this study is to explore the pathogenesis of cognitive impairment after acute~     cerebral infarction by applying the multimodal function MRI to dynamically observe the~     changes of the value of NAA,Cho,Cr,FA in a certain region in the brain and the function of~     the brain ,and to provide a visual instrument for evaluating the therapeutical effects of~     Chinese medicine through the application of multimodal function MRI to observe the changes of~     the neurotransmitter in certain area in the brain before and after the treatment.~   "
62191|NCT02752854|"~     one measurement of pain threshold in high altitude and in low altitude using pressure~     algometer and Situational pain scale.~   "
62192|NCT02752841|"~     Examine the effect of nutritional vitamin D repletion on urinary calcium excretion and kidney~     stone burden in calcium kidney stone formers~   "
62193|NCT02752828|"~     Primary Objective:~      To compare LixiLan to insulin glargine in glycated hemoglobin (HbA1c) change from baseline to~     Week 26 in patients with type 2 Diabetes.~      Secondary Objective:~      To compare the overall efficacy and safety of LixiLan to insulin glargine (with or without~     OADs) over a 26 Week treatment period in patients with type 2 Diabetes.~   "
62194|NCT02752815|"~     This is a clinical trial to compare the efficacy and safety of four cycles of R-CHOP followed~     by four cycles of Rituximab with six cycles of R-CHOP followed by two cycles of Rituximab in~     the treatment of de novo, low-risk, non-bulky diffuse large B-cell lymphoma.~   "
62195|NCT02752802|"~     The purpose of this study is to evaluate the amount of contrast media (CM) saved using the~     DyeVert system in diagnostic angiographic procedures compared to a control group.~   "
62196|NCT02752789|"~     This is a multi-center, prospective, single cohort, observational study of pediatric heart~     transplant recipients designed to determine the impact of preformed versus de novo human~     leukocyte antigen (HLA) donor-specific antibodies (DSA), and antibodies to the self-antigens~     cardiac myosin and vimentin, on chronic allograft function. In addition, the investigators~     will explore mechanisms of action and predictors of DSA, rejection and altered~     pathophysiology.~   "
62197|NCT02752776|"~     Study of effects of secukinumab 300 mg s.c. on quality of life (QoL) in psoriasis patients~     with or without prior exposure to systemic therapy.~   "
62198|NCT02752763|"~     Dry eye is a significant adverse effect of isotretinoin causing patients to use ophthalmic~     medications. For this reason, many patients using isotretinoin are referred to ophthalmology~     clinic because of discomfort symptoms. In the literature, there are studies suggesting~     superiority of Autologous serum drops regarding effects on ocular surface when compared to~     artificial tear. In addition, Autologous serum was also used in several corneal pathologies~     with successful outcomes. No data regarding use in the ocular adverse effects of isotretinoin~     was found in the literature; however, investigators think that it may be an effective~     alternative in the treatment of dry eye developed during isotretinoin use due to positive~     effects on ocular surface, epithelial regeneration and anti-inflammatory effect. Autologous~     serum can be a choice of ophthalmologists in routine practice by increasing number of~     comprehensive studies investigating effectiveness, safety and long-terms effects of~     Autologous serum therapy.In this study, it was aimed to investigate dry eye development in~     the patients receiving systemic retinoic acid therapy and to compare effectiveness of~     Autologous serum and Preservative free artificial tear in the patients with dry eye disease.~   "
62201|NCT02752724|"~     The purpose of this prospective randomized clinical trial is to determine if patients~     receiving ketamine as a part of general anesthesia during electroconvulsive therapy (ECT)~     rather than standard of care will have improvement in symptoms of depression after a course~     of ECT treatments. The investigators hypothesize that utilization of ketamine for induction~     of general anesthesia during ECT treatments will improve symptoms of depression better than~     standard care.~      This study is ONLY open to patients eligible to receive healthcare services through the~     Department of Veterans Affairs at the VA Puget Sound, which means service in the active~     military, naval or air service or separation under any condition other than dishonorable.~     Qualifications for VA health care benefits can be found at va.gov.~   "
62202|NCT02752711|"~     To date, the Pediatric Emergency Care Applied Research Network (PECARN) rule for identifying~     children who are at very low risk of clinically-important traumatic brain injuries after~     minor head trauma has not been validated prospectively in an independent population. Our goal~     was to evaluate the diagnostic performance of the PECARN clinical decision rule in a French~     pediatric population in multiple clinical settings.~   "
62203|NCT02752698|"~     Central South University in collaboration with Tianjin University developed the first~     domestically produced Chinese minimally invasive surgical (MIS) robot system which named~     Micro Hand S in 2013. Recently, as the domestic surgical robot research project's main~     section, this new MIS robot had been authorized to enter the clinical trial stage by the~     Ethics Committee of the Third Xiangya Hospital at Central South University.~   "
62204|NCT02752685|"~     This is a single-arm open-label multi-cohort Phase II study evaluating the~     safety/tolerability and clinical activity of the combination of nab-paclitaxel and the~     antibody against programmed cell death 1 (PD-1), pembrolizumab, in patients with human~     epidermal growth factor receptor (HER-2) negative metastatic breast cancer (n=50). There will~     be two cohorts of patients consisting of a triple negative breast cancer (TNBC) cohort with~     30 subjects and a hormone receptor (HR)-positive cohort with 20 subjects. There will be an~     initial safety run-in with 12 subjects from the TNBC and HR-positive cohort (~ 6 patients~     from each cohort). If no unexpected toxicity is observed (as defined in the study protocol),~     then enrollment will continue to complete both cohorts (30 total TNBC, 20 total in HR~     positive cohort). The subjects from the run in safety part will be included in the Phase II~     analysis. Tumor expression of programmed cell death ligand 1 (PD-L1) is not required for~     enrollment in the study, but will be assessed as possible predictive marker.~   "
62205|NCT02752672|"~     Dithranol (known in the U.S.A. as anthralin and in Germany as cignolin) is one of the oldest~     and safest topical anti-psoriatic treatments. However, despite explorative investigations,~     the skin disease-clearing mechanisms of dithranol remain poorly understood (Painsi et al,~     JDDG 2015). The purpose of this study is to investigate the therapeutic mechanisms of~     dithranol in psoriasis.~   "
62206|NCT02752659|"~     Early detection and treatment of onset or worsening of breast cancer-related lymphedema~     (BCRL) can potentially prevent or postpone the condition to progress into a chronic~     progressive condition or eliminate the risk of infections in the arm (cellulitis).~     Self-surveillance for BCRL by routinely measuring own arm circumference could potentially~     enable early detection of onset or worsening of lymphedema. The aim is to determine whether~     women who have received surgery for breast cancer, can perform self-measures of arm~     circumference in a reliable and valid manner using written and video supported instructions~     without in-person teaching by a physiotherapist.~   "
62207|NCT02752646|"~     This study will examine the tolerability and toxicity of topically applied Nepafenac 0.3% vs~     ketorolac 0.5% among patients undergoing cataract surgery.~   "
62208|NCT02752633|"~     This exploratory pilot study was an open-label, crossover, single-center and non-randomized~     clinical trial designed to compare the effect of the standardly employed doses of allopurinol~     (400 mg/day) and febuxostat (80 mg/day) on the urinary 2,8-dihydroxyadenine (DHA) excretion~     in patients with adenine phosphoribosyltransferase (APRT) deficiency.~   "
62209|NCT02752620|"~     This study evaluates the effectiveness of treatment osteopathic manipulation in the treatment~     of subjects with chronic nonspecific low back pain.~   "
62210|NCT02752607|"~     Background: Venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and~     pulmonary embolism (PE), is the third most common cardiovascular disorder after myocardial~     infarction and stroke. VTE occurs in about 1 person per 1,000 per year, increasing~     dramatically in patients with cancer to about 25 per 1,000 per year. Among the known risk~     factors of VTE, cancer is one of the most potent. Patients with cancer have a 7- to 28-fold~     higher risk for VTE than non-cancer patients. VTE has important implications for the care of~     cancer patients, including reduced life expectancy, high rates of VTE recurrence both while~     on and after stopping anticoagulation, the need for chronic anticoagulation with related~     adverse drug reactions, and delays in cancer therapies. Clinical dilemma: Current clinical~     guidelines recommend a minimum of 3-6 months of anticoagulation with weight-adjusted low~     molecular weight heparin (LMWH) in cancer patients with VTE. However, there are no~     recommendations beyond the initial 6 months of therapy due to the lack of data on extended~     duration therapy for cancer-associated thrombosis (CAT). This leads to variability in~     physician practices, with some continuing weight-adjusted LMWH therapy beyond 6 months. This~     poses concern because, while the goal is to prevent recurrence of VTE, the risk of major~     bleeding with prolonged weight-adjusted LMWH therapy is significant. Potential solutions:~     There is a lack of data to inform on VTE treatment in cancer patients beyond the initial 3-6~     months of anticoagulation. We propose that after a minimum of 3-6 months of therapeutic dose~     anticoagulation, the use of prophylactic doses of LMWH will have an acceptable and adherence~     profile in cancer patients with VTE. The data obtained from this study will help inform~     physician practices. Design: This is a multicentre, open-label study of enoxaparin (40 mg~     subcutaneous injection, once daily) for additional 6 months after an initial minimum~     3-6-month course of therapeutic dose anticoagulant therapy. Patients: 150 patients with VTE~     secondary to cancer will take part in this multicentre study conducted in 8 Canadian centres~     within Quebec, Ontario and Nova Scotia. Study Outcomes: The primary objective of the study is~     to determine the rate of recurrent VTE in patients receiving prophylactic dose enoxaparin for~     secondary VTE prophylaxis after an initial minimum 3-6 months of anticoagulation. The~     secondary objective is to determine the safety profile of prophylaxis dose enoxaparin for~     secondary VTE prophylaxis after an initial 3-6 months of anticoagulation. This includes~     determining for all subjects: 1) cumulative incidence of major bleeding events; 2) cumulative~     incidence of clinically relevant non-major bleeding events; 3) cumulative incidence of minor~     bleeding event, and 4) overall survival during follow-up.~   "
62211|NCT02752594|"~     Dental caries is a multifactorial disease effecting majority of the human population.One of~     the etiological factor causing dental caries is salivary mutans streptococci. Reducing the~     levels of this bacteria in the saliva can significantly reduce the incidence of dental~     caries. A non-invasive intervention, such as the administration of probiotics reduced the~     salivary mutans streptococci levels.~   "
62212|NCT02752581|"~     The study was designed to investigate efficacy of suction drains in arthroscopic knee~     surgery, rather than anterior cruciate ligament (ACL) reconstruction. two groups were~     randomised, and suction drain was applied to one group, and the other group as the control~     group without a suction drain.~   "
62213|NCT02752568|"~     300 recurrent implantation failure patients will be alternatively assigned to assisted~     hatching , endometrial scratch , and no treatment ,100 patients in each group~   "
62215|NCT02752542|"~     Depression currently affects close to 2 million Canadians and is the leading cause of~     disability worldwide. Pharmacological treatments (antidepressant medication) and~     psychological treatments such as cognitive-behavioural therapy are available for depression,~     but the majority of those who receive treatment have an unsatisfactory response. On average,~     the combination of pharmacological and psychological treatment achieves better results than~     either treatment alone. However, the apparently superior results of combination treatment may~     be due to the fact that different individuals preferentially respond to pharmacological or~     psychological treatment. The invesitagtors have discovered several clinical factors and~     biomarkers that predict poor response to commonly used antidepressant medication: history of~     childhood maltreatment, loss of interest and reduced activity, a biomarker of systemic~     inflammation, and a genetic marker of sensitivity to environment. Indirect evidence suggests~     that the same factors may indicate the need for psychological treatment, but their usefulness~     as differential predictors of psychological and pharmacological treatment outcomes remains to~     be established.~      The investigators will test the hypothesis that a pre-determined set of clinical variables~     (history of childhood maltreatment, loss of interest and reduced activity) and biomarkers~     (serum C-reactive protein, a marker of systemic inflammation, and short alleles of the~     serotonin transporter gene promoter polymorphism) differentially predicts response to~     antidepressants and to cognitive-behavioural psychotherapy with clinically significant~     accuracy.~      If this hypothesis is supported, the resulting predictor will allow personalized selection of~     treatment for depression, leading to improved outcomes and healthcare efficiency. Additional~     objectives include replication of additional predictors and integrative analyses aimed at~     refining the treatment choice algorithms.~   "
62216|NCT02752529|"~     Combined with the clinical data of FK506 and the database of GO and Kyoto Encyclopedia of~     Genes and Genomes（KEGG）, the investigators aim to carry out the bioinformatic analysis and~     build a muti-locus genetic model, then muti-center assess the predictive accuracy of FK506~     metabolic differences.~   "
62217|NCT02752516|"~     A Phase I Additional Study of Anlotinib on Tolerance and Pharmacokinetics.To further study~     the pharmacokinetic characteristics of Anlotinib in the human body, recommend a reasonable~     regimen for subsequent research.~   "
62218|NCT02752503|"~     The objective is to study the effectiveness of Nalmefene in decreasing alcohol intake in~     subjects with alcohol use disorder and comorbid BPD.~   "
62219|NCT02752490|"~     The objective of this study is to determine if a strategy of indicated compared to liberal~     oxygen administration in labor decreases the rate of cesarean delivery. The hypothesis is~     that women who undergo a strategy of indicated compared to liberal oxygen administration in~     labor will have lower rate of cesarean delivery and fetal acidemia at birth.~   "
62220|NCT02752477|"~     The objective of this trial is to determine whether an opioid-free general anesthetic (OFA)~     technique utilizing ketamine, dexmedetomidine, and lidocaine infusions can help reduce~     postoperative pain in opiate-dependent chronic pain patients (CPPs) undergoing spine surgery~     when compared with traditional opioid-containing techniques. It is expected that this OFA~     regimen will have a measurable reduction on postoperative opioid consumption and pain scores~     in CPPs.~   "
62221|NCT02752464|"~     Overweight/obesity is strongly linked to mortality from multiple chronic diseases, including~     cardiovascular disease, diabetes, and obesity-related cancers.The successful management of~     overweight/obesity requires management of nutrition and physical activity over time. For~     racial/ethnic minority and low-income populations, who face both higher prevalence of obesity~     and chronic diseases compared to others, interventions promoting behavioral change are a~     national health priority. From the available range of behavioral change intervention~     strategies, there is a growing knowledge base that documents the efficacy of peer support~     interventions for improving self-care, quality of life, and behavioral change. In this study,~     the investigators will examine the following research question: What is the preliminary~     efficacy and degree of implementation and acceptability of an intervention approach in which~     peer counselors provide evidenced-based counseling about nutrition and physical activity~     behaviors for weight management to public housing residents using a computer-assisted program~     called CuesWeight?~   "
62222|NCT02752451|"~     Comparison of success rates of novice surgeons to attain proficiency in basic arthroscopy~     skills after receiving prior training with different simulation systems.~   "
62223|NCT02752438|"~     Although High Frequency Oscillatory Ventilation (HFOV) has been used in case of unresponsive~     to conventional mechanical ventilation both in children and newborns, there is no data on its~     success and the factors that affect its success in the literature.~   "
62224|NCT02752425|"~     Speech is a privileged means of communication for humans: its trouble can thus prove being~     extremely handicapping. Standard speech therapy is limited in some cases by the lack of~     sensory feedback available to the patient (hearing, surgery, neural damage, etc.).~      The present study aims at quantify the contribution of the tongue articulatory visual~     feedback offered by ultrasound echography to speech trouble rehabilitation.~      Two complementary populations will be studied : 30 adults with buccopharyngeal surgery, and~     10 childrens with important speech troubles due to central nervous system damage.~      The principle is to conduct standard speech therapy sessions, alternating series of sessions~     with the use of visual feedback and sessions without visual feedback.~      The progress will be regularly measured by means of standard batteries of speech articulation~     tests.~   "
62225|NCT02752412|"~     Primary Objective:~      To compare LixiLan to insulin glargine in glycated hemoglobin (HbA1c) change from baseline to~     week 26 in patients with type 2 diabetes mellitus.~      Secondary Objective:~      To compare overall efficacy and safety of LixiLan to insulin glargine over 26 weeks in~     patients with type 2 diabetes mellitus.~   "
62226|NCT02752399|"~     The purpose of this study is to verify the applicability Six minutes walk test and Shuttle~     walk test in assessing functional capacity in patients with Eisenmenger Syndrome. Patients~     will undergo three functional tests, being the six-minute walk test, shuttle walk test and~     cardiopulmonary exercise test on a cycle ergometer, associated with evaluation of metabolic~     and ventilatory variables and cardiac monitoring throughout the test.~   "
62227|NCT02752386|"~     The purpose of this study is to test whether a novel form of biofeedback training can help~     individuals regulate their pain more effectively.~   "
62228|NCT02752373|"~     This is an open label prospective study of the impact on healthcare utilization of a surface~     Electromyography (sEMG) based seizure detection system for detecting Generalized Tonic-Clonic~     (GTC) Seizures.~   "
62229|NCT02752360|"~     Intestinal anastomosis plays an important role in various general surgeries, but the~     complications such as anastomotic leakage,stenosis and hemorrhage cannot been avoided.~     Although many ways are put up to solve this problem, there are still many imports need to~     improve. Therefore, the Biodegradable Stenting Anastomoses(BSA), which make intestinal~     anastomosis easily and less complications, have been produced.The major goal of this study is~     to evaluate the efficacy of Biodegradable Stenting Anastomoses(BSA) for reconstruction in~     surgery of intestinal anastomosis.~   "
62233|NCT02752308|"~     From September 2014 to March 2015, 57 consecutive patients with hypospadias who are candidate~     for surgery will be enrolled in this randomized clinical trial.~      Regional ethics committee of Isfahan University of Medical Sciences approved the protocol of~     the study and all parents will sign a written informed consent.~      Inclusion criteria are age between 6 months to 15 years and hypospadias with any severity.~     Exclusion criteria are coagulopathy, history of previous failed surgery, skin infection ,~     parents' disagreement with the protocol and any cardiac problem that made epinephrine~     injection contraindicated.~      All selected patients will randomly allocate to one of the two groups: group A will receive~     caudal epidural block (CEB) plus general anesthesia before surgery and group B will receive~     general anesthesia before surgery and CEB afterwards. The surgical procedures will be~     performed by a single pediatric urologist (FA). The surgical technique will be tubularized~     incised plate in all cases.~      Intraoperative blood loss will be determined by weighing all surgical gauzes used during~     procedure with a digital scale measure to the nearest 0.01 gram, every 10 minutes to minimize~     the effect of water vaporization on gauzes weights.~      In addition to blood loss, operation time, dose of fentanyl used during procedure and length~     of the urethral plate defect will be recorded for each patient by trained nurses.~      Demographics and disease characteristics as well as operation details will be compared in the~     two studied groups.~   "
62234|NCT02752295|"~     This study intents to determine who will benefit from an intensive brief stress coping~     intervention week (ISCIW) as secondary prevention for real world affective disorder patients.~   "
62235|NCT02752282|"~     This study is a counseling intervention for new LNG-IUS users. The study explores the use of~     video technology to deliver anticipatory counseling on LNG-IUS side-effects, adjustment~     periods and bleeding changes to women newly using the LNG-IUS for contraceptive purposes. The~     primary aim is to understand if anticipatory counseling delivered via video can increase~     LNG-IUS satisfaction and continuation of the device in the first 6 months of use.~   "
62236|NCT02752269|"~     According to the literature available pulmonary hypertension is present in 12 to 23% of~     patients suffering from Sjögren Syndrome. However epidemiological data are based on~     non-invasive measurements using echocardiography. Furthermore, no data are available~     regarding exercise hemodynamics in those patients.~      This study investigates pulmonary hemodynamics at rest and during exercise in patients~     suffering from primary and secondary Sjögren Syndrome. Patients under suspicion for pulmonary~     hypertension (PH) will be offered further investigations including right heart~     catheterization.~   "
62237|NCT02752256|"~     Evaluation of ischemic stroke patients receiving tissue plasminogen activator (rtPA) during~     air ambulance transfer~   "
62238|NCT02752243|"~     Multi-site, non-randomized Phase I/II study involving children and adults.~   "
62239|NCT02752230|"~     This study is designed to evaluate the use of bupivacaine liposome 1.3% compared bupivacaine~     0.5% in pain control in post-operative laparoscopic bariatric surgery patient The purpose of~     this study is to evaluate two local anesthetics and determine if there is an advantage of~     administering one medication compared over the other. The intent is show that one local~     anesthetic.allows for improved pain control as per the pain scale ratings of the test~     subjects.~   "
62240|NCT02752217|"~     Study the effects of inspiratory muscle training at Low load of 25 %Maximal inspiratory~     pressure with slow breathing rate at 6 breaths/min on inspiratory muscle strength, lung~     function, chest wall expansion, abdominal expansion, exercise capacity and blood pressure in~     elderly with Isolated systolic hypertension.~   "
62241|NCT02752204|"~     The aim of this clinical trial is to see if the drug called AZD2014 is effective and safe to~     use to treat patients with relapsed or refractory Diffuse Large BCell Lymphoma (DLBCL). The~     trial will also be looking at combining the antibody (Rituximab) with the drug AZD2014 in a~     small number of patients to see if this can be done without increasing the toxicity. 36~     patients will be recruited to the trial. 30 will receive AZD2014 alone and the remaining 6~     will receive AZD2014 plus rituximab. AZD2014 will be given as a 125mg tablet that is to be~     taken twice a day for 2 days out of every 7 (i.e. on days 1 and 2 of every week). Rituximab~     will be given via IV infusion on day 1 of every 28 days (once every 4 weeks) for a maximum of~     6 cycles.~   "
62242|NCT02752191|"~     The standard clinical cardiovascular MRI practice for children with CHD frequently involves~     the use of gadolinium-based contrast agents (GBCA) to enhance tissue contrast. Most GBCAs are~     small molecules that quickly cross the capillary wall and access the interstitial space, a~     process which diminishes the signal contrast between blood vessels and surrounding tissue.~     Therefore, these types of GBCA are most useful for first-pass MR angiography, wherein the~     images are acquired quickly during the initial 15-30 seconds post-injection when the GBCA~     concentration is much higher in the arteries than in the interstitial space. For young~     children with complex CHD, the stringent requirements for high spatial resolution, and the~     need for cardiac gating and good blood-myocardium contrast in order to provide detailed~     evaluation of intracardiac structures are not compatible with conventional GBCA-based~     first-pass MR angiography. Even with Ablavar® (gadofosveset trisodium), an FDA approved GBCA~     with longer intravascular half-life than other GBCAs, cardiac-gated Ablavar®-enhanced MRI may~     be insufficient for young children with CHD based on our institutional experience and on data~     from the literature; there remains diminished blood-tissue contrast during the~     high-resolution cardiac-gated MRI. Furthermore, there have been safety concerns regarding~     gadolinium deposition in brain tissues after repeated GBCA exposure as well as concerns of~     nephrogenic systemic fibrosis (NSF) associated with GBCA injection in young children < 2~     years old who may have immature renal function. The long-term health consequences of these~     effects in the pediatric population are unclear. For the above reasons, we seek to study the~     diagnostic imaging effectiveness of Feraheme (Feraheme®), an FDA-approved drug for parenteral~     iron supplementation, as an MRI contrast agent in children with CHD. Although Feraheme® has~     been approved for the treatment of iron deficiency anemia secondary to renal disease,~     Feraheme® has been used as an off-label MRI contrast agent at select medical centers.~   "
62250|NCT02752087|"~     This study of healthy participants will evaluate the concentration of a test LY900014 and a~     reference LY900014 formulation in the bloodstream and how it affects the blood sugar levels.~     The whole study, including screening, will take up to 8 weeks to complete.~   "
62251|NCT02752074|"~     The purpose of the study is to assess the efficacy, safety, and tolerability when combining~     pembrolizumab with epacadostat or placebo in subjects with unresectable or metastatic~     melanoma~   "
62306|NCT02751333|"~     Esophageal stents are commonly used for benign esophageal pathology, especially strictures or~     esophageal mucosal defects such as leaks, fistulae, or perforations. The major limiting~     factor to stent placement is the high migration rate of the stent. Investigators are trying~     to prospectively evaluate the efficacy of endostitch in preventing stent migration in benign~     esophageal disease in comparison with standard, fully covered self-expanding metal stents~     (FCSEMS) placement without fixation.~   "
62243|NCT02752178|"~     This is a study to characterise the role of inflammatory processes in depression. There is~     compelling evidence that inflammation is often associated with, and can cause, depression. It~     is currently less clear that antiinflammatory drugs have meaningful antidepressant effect.~     One of the goals is to identify the subset of depressed patients that is most likely to~     respond better to an antiinflammatory drug than to a conventional antidepressant. The~     investigators will therefore undertake a study of patients with a diagnosis of major~     depressive disorder including four groups: i) incompletely responsive patients who have~     demonstrated failure to respond consistently or completely to standard treatment, ii) those~     who have responded well to treatment and are not currently depressed, iii) untreated patients~     who are currently depressed, iv) healthy volunteers with no history of depression.~     Participants will undergo a clinical assessment, an interview with a trained member of the~     research team and will complete self-rated questionnaires. Investigators will collect blood~     and saliva samples to measure certain immune markers. They will also perform magnetic~     resonance imaging (MRI) scans to look for MRI markers in the brain and investigate brain~     inflammation in a subsample of these patients using positron emission topography (PET) and~     cerebrospinal fluid (CSF) sampling (also called lumbar puncture).~   "
62244|NCT02752165|"~     In the US, children from minority ethnic and racial backgrounds suffer disproportionately~     from asthma and account for substantially more emergency department (ED) visits and~     hospitalizations than non-minority children. While NHLBI guidelines recommend daily~     preventive medications for all children with persistent asthma to prevent morbidity as well~     as ED visits and hospitalizations, many children who should receive preventive medications~     are not receiving them. This is in part because children presenting to the ED for an acute~     asthma exacerbation rarely receive preventive asthma care, due to the ED's focus on acute,~     episodic care. The NHLBI guidelines recommend that children follow-up with a primary care~     provider (PCP) within 1-4 weeks of the ED visit. The post-ED follow-up visit is an~     opportunity for the PCP to prescribe effective preventive asthma medications, step-up~     medication for children who demonstrate poor control, promote adherence, and provide~     education on asthma self-management and trigger control. However, rates for follow-up after~     an asthma-related ED visit are extremely low, and preventive care is delivered inconsistently~     even when children are seen in follow-up. In the investigators' prior work they have found~     that a provider prompting intervention can enhance the delivery of guideline-based preventive~     asthma treatments at the time of a primary care office visit and ultimately reduce morbidity.~     They have also found that telemedicine can link children with persistent asthma to a provider~     for optimal chronic illness management. The goal of this project is to use a novel~     telemedicine-based program to facilitate primary care follow-up and promote the delivery of~     guideline-based preventive care for high-risk children presenting to the ED for an asthma~     exacerbation. The investigators will utilize a 2-group randomized trial to test the TEAM-ED~     intervention. The intervention includes: 1) a telemedicine assessment at the child's school~     within one week of discharge from the ED and completed by a PCP, 2) 'point-of-care' prompting~     to promote the provision of guideline-based preventive care during the telemedicine visit,~     and 3) two additional telemedicine-assisted follow-up assessments to assure optimal response~     to treatment and tailor the care regimen as needed. The investigators will assess the~     effectiveness of the program in reducing respiratory morbidity and improving preventive~     asthma care, with follow-up assessments at 3, 6, 9, and 12 months.~   "
62245|NCT02752152|"~     The primary objective of the study is to evaluate and compare, in at-risk populations, the~     efficacy of three different counseling methods in terms of propensity to come back for a HIV~     re-test. Secondary objectives are to evaluate and compare the efficacy of the counseling~     methods in terms of reported risk behavior and HIV knowledge as well as their acceptability~     and cost-effectiveness, describe the distribution of duration from HIV primary infection to~     detection, and estimate the prevalence of chronic hepatitis B and C, and syphilis in~     HIV-uninfected participants of targeted populations.~      The objective of the reminder intervention is to evaluate the cost-effectiveness of~     reminders.~   "
62246|NCT02752139|"~     The purpose of this study is to determine the relationship between sleep disorders and~     cerebral hemodynamics.~   "
62247|NCT02752126|"~     A randomized phase II study of palliative radiation of advanced central lung tumors with~     intentional avoidance of the esophagus. Patients will be randomized between standard of care~     palliative thoracic radiation and esophageal-sparing intensity-modulated radiation therapy~     (ES-IMRT) in a 1:1 ratio. Radiotherapy will be administered as soon as possible following~     randomization and subjects will be followed for 1 year after completion of their radiation~     therapy. The primary endpoint is esophageal quality of life as measured by the Esophageal~     Cancer Subscore (ECS) of the Functional Assessment of Cancer Therapy-Esophagus (FACT-E).~   "
62248|NCT02752113|"~     Diabetes mellitus is a wide-spread disease accompanied by strongly increased morbidity and~     mortality due to micro- and macrovascular complications. However, in studies with patients~     suffering from diabetes mellitus type 2 (DM 2), early changes and impairments in large and~     small blood vessels as well as organ damage (e. g. to the kidneys) have been only~     insufficiently investigated (1). The newest substance class in oral antidiabetics, i. e.~     SGLT-2-inhibitors (such as empagliflozin) cause an increased renal excretion of glucose. In~     addition, the concurrent increased sodium excretion brings about an improvement of vascular~     function and thus a decrease in blood pressure. In the EMP-REG-OUTCOME study (2), the~     cardiovascular mortality rate was significantly lower in the empagliflozin group (3.7% versus~     5.9%; 38% relative RR) compared to placebo.For another new substance class, the~     dipeptidylpeptidase-4-inhibitors, a number of pleiotropic effects have been described (3). In~     one of our recently conducted trials, we could demonstrate a positive effect of linagliptin~     on renal an inflammatory parameters compared to placebo (4). Thus, the combination of both~     substance classes with regard to positive effects on micro- and macrocirculation, even though~     not sufficiently proven as yet, suggests itself. The therapy with metformin and long-acting~     insulin (BOT), as well as a twofold oral medication is possible according to the~     recommendations of the Deutsche Diabetes Gesellschaft (DDG) and the positional paper of the~     American Diabetes Association (ADA). Accordingly, the aim of the present paper is the~     analysis of the effects of a combined therapy with empagliflozin plus linagliptin compared to~     metformin plus insulin glargine on renal and vascular changes in type 2 diabetes mellitus.~   "
62249|NCT02752100|"~     Along with the improvement of living standard, the prevalence of Lower extremity arterial~     occlusive disease (LEAOD) is also increasing, which has become an important cause of lower~     extremity amputation and greatly affected the patients' life quality. Currently, percutaneous~     transluminal angioplasty (PTA), including balloon dilatation and stent implantation, has been~     regarded as the most widely applied and accepted treatment for LEAOD. The therapeutic effects~     of lower extremity interventional treatment, varied in different reports. It was reported~     that the therapeutic effects were influenced by some traditional risk factors, including age,~     gender, smoking, and so on. More risk factors are still unknown. The difference of~     therapeutic effects, the endpoint events were compared between interventional and~     conventional treatment group to analyze the effect of interventional treatment on LEAOD and~     explore its risk factors.~   "
62327|NCT02751060|"~     The purpose of this study is to determine whether the expression level of miR-320a are~     effective as biomarker in evaluating the diagnosis, prognosis and treatment effects of~     coronary heart disease.~   "
62252|NCT02752061|"~     Diagnostic and treatment delays contribute substantially to disparities in cancer morbidity~     and mortality between low- and middle- income countries (LMICs) and high-income countries.~     Individuals present with advanced stage disease resulting in minimal chance for cure or~     long-term survival.~      The Potlako project will implement and evaluate a multifaceted intervention to test the~     hypothesis that a package of enhanced coordination of care including an electronic messaging,~     transportation support, and training targeted at generalist clinicians at primary and~     secondary level facilities, can reduce time to diagnosis and stage at diagnosis for~     HIV-infected individuals with cancer.~   "
62253|NCT02752048|"~     The objective of this study is to evaluate the efficacy after 24-week repeated oral doses of~     TAS-205 in patients with Duchenne Muscular Dystrophy (DMD) in an exploratory manner.~   "
62254|NCT02752035|"~     This is a clinical study for adult patients who have recently been diagnosed with acute~     myeloid leukemia or AML. AML is a type of cancer. It is when bone marrow makes white blood~     cells that are not normal. These are called leukemia cells. Some patients with AML have a~     mutation, or change, in the FLT3 gene. This gene helps leukemia cells make a protein called~     FLT3. This protein causes the leukemia cells to grow faster. For patients with AML who cannot~     receive standard chemotherapy, azacitidine (also known as Vidaza®) is a current standard of~     care treatment option in the United States. This clinical study is testing an experimental~     medicine called ASP2215, also known as gilteritinib. Gilteritinib works by stopping the~     leukemia cells from making the FLT3 protein. This can help stop the leukemia cells from~     growing faster. This study will compare three different treatments. Patients are assigned to~     one of these three groups by chance: an experimental medicine gilteritinib, a different~     medicine called azacitidine, also known as Vidaza®, or both medicines (azacitidine and~     gilteritinib) together. The clinical study may help show which treatment helps patients live~     longer.~   "
62255|NCT02752022|"~     Electronic cigarettes (e-cigarettes) have proved very popular and a meteoric rise in their~     usage is currently under way. People purchase them as an aid to giving up smoking, to reduce~     cigarette consumption, to minimise withdrawal symptoms in occupational environments that ban~     smoking, and in order to continue smoking with decreased health risks. Although the safety~     and impact on health of electronic cigarettes, especially after long-term use, has not been~     evaluated, they are generally considered to be far safer alternatives to cigarette smoke.~     Electronic cigarettes do not generate polycyclic aromatic hydrocarbons, a potent class of~     carcinogenic chemicals generated during the combustion of tobacco and making important~     contribution to the cigarette-induced cancer. However, carcinogenic tobacco-specific~     nitrosamines have been encountered in e-cigarettes being detected in some nicotine cartridges~     as contaminants, albeit at very low concentrations in comparison with tobacco smoke.~     Consequently, it is imperative to ascertain the toxicity risk (if any) of consuming nicotine~     intake through electronic cigarettes. This European Commission funded study will monitor~     levels of carcinogenic tobacco-specific nitrosamines in urine of heavy smokers who give up~     smoking and completely transition to e-cigarette use for a period of 4 weeks. Levels of other~     compounds which are known to be associated with smoking toxicity, such as DNA adducts and DNA~     methylation, will also be monitored in biological fluids of these subjects. Finally,~     cigarette craving, mood, anxiety, social anxiety, well-being status and stress hormones will~     be measured in smokers transitioning to e-cigarettes for 4 weeks to assess the psychological~     effect of the transition. The results from the study will provide important information on~     the safety and effectiveness of e-cigarettes for smoking cessation which investigators~     anticipate to drive policy.~   "
62256|NCT02752009|"~     This research protocol is studying the accuracy of the sentinel lymph node biopsy procedure~     in breast cancer patients who have cancer cells in the lymph nodes in the armpit (axilla) who~     have received chemotherapy or endocrine therapy prior to having surgery (neoadjuvant~     therapy).~   "
62257|NCT02751996|"~     This is a Phase 2, open-label,randomized, multiple dose, varied administration regimen study~     with 2 parts (Parts A and B) in Subjects Infected with Chronic Hepatitis B Virus~   "
62258|NCT02751983|"~     An estimated 20 Veterans kill themselves every day. Suicide prevention literature and public~     health policy both call for treatment targeting high-risk populations, such as Veterans~     hospitalized due to suicidal intent and/or attempts. Psychiatric hospitalization is a~     critical opportunity to provide treatment to reduce the risk of suicide and lay the~     groundwork for functional recovery. Yet, there are no interventions specifically for suicide~     prevention that meet Veterans Health Affairs' quality recommendations requiring the provision~     of evidence-based, recovery-oriented psychotherapy, which are also feasible to use during a~     typical inpatient stay. The proposed study seeks to take a first step toward filling this~     gap. In consultation with experts in the field, the authors have developed a protocol~     applying a recovery-oriented, evidence-based treatment approach to Veteran inpatient care.~     The proposed pilot study will provide critical information to inform final revisions of the~     treatment manual and research design for a future study evaluating the efficacy of the~     intervention.~   "
62259|NCT02751970|"~     This study aims to evaluate the clinical effectiveness of contemporary resin-based adhesive~     systems by retention rate of resin restorations placed in non carious cervical lesions with~     four different adhesive strategies: 3 and 2 steps etch-and-rinse adhesive system, 2 and 1~     step self-etch adhesive systems.~   "
62260|NCT02751957|"~     This Mentored Career Development Award will lay the foundation for a career focused on~     addressing two Grand Challenges in Global Mental Health priorities: 1) improving child access~     to evidence-based mental health care, and 2) reducing the duration of untreated illness by~     developing culturally-sensitive early interventions. The proposed research aims to assess~     implementation barriers and facilitators as well as the impact of a brief caregiver coaching~     early autism intervention adapted for use in a low resource setting. Data from this pilot~     study would inform scalable early autism intervention programs for implementation in~     underserved, low resource, and low-literacy populations globally.~   "
62261|NCT02751944|"~     This study is intended to evaluate the effect of the dietary supplement NEM® brand eggshell~     membrane versus placebo in reducing exercise-induced joint pain & stiffness & cartilage~     turnover in healthy post-menopausal women. Half of the study participants will receive NEM,~     once daily, orally while the other half of the study participants will receive placebo, once~     daily, orally.~   "
62262|NCT02751931|"~     A study to evaluate the efficacy, safety and tolerability, and pharmacokinetics of mirabegron~     after multiple-dose administration in the pediatric population.~   "
62263|NCT02751918|"~     Anetumab ravtansine is developed for the treatment of patients with recurrent~     platinum-resistant ovarian cancer. The purpose of the proposed trial is to identify the~     maximum tolerated dose of anetumab ravtansine that could be safely combined with pegylated~     liposomal doxorubicin in this indication.~   "
62264|NCT02751905|"~     The primary objectives of the study are: To determine the mass balance and routes of~     elimination of BIIB074 and its known metabolites following administration of a single oral~     dose of BIIB074 in healthy male participants and To describe the pharmacokinetics (PK) of~     BIIB074 and its known metabolites and the disposition profiles of total radioactivity in~     whole blood and plasma following a single oral dose. The secondary objectives of this study~     are: To assess the safety and tolerability of BIIB074 in healthy participants and To identify~     and characterize any additional metabolites of BIIB074 in plasma, urine, and feces.~   "
62265|NCT02751892|"~     Long-term maintenance of physical activity behaviour change post-intervention remains~     challenging. This study is investigating the feasibility of a behaviour change intervention~     based on Self-Determination Theory in people recovering from colorectal cancer and its~     effects on behaviour change 6 months post-intervention.~   "
62266|NCT02751879|"~     This is a non-interventional, multi-country, multi-site study based on existing data from~     medical records of patients treated with Gi(l)otrif® as part of the routine treatment~     according to the approved label. Data from real-world will help to understand if dose~     modifications are done similar as in LUX-Lung 3 trial and if the outcome on safety and~     effectiveness are as in trial settings. Furthermore, data on modified starting doses, the~     underlying reasons and effects on safety and outcome are needed.~   "
62267|NCT02751866|"~     Nutritional intervention in overweight middle aged individuals with subjective memory~     complaints.~   "
62268|NCT02751853|"~     Aim of the study is to assess the effects of abruptly increased afterload on left ventricular~     contractility and relaxation in patients with heart failure with preserved ejection fraction~     (HFPEF), patients with heart failure with reduced ejection fraction (HFREF), and patients~     without HFPEF or HFREF.~   "
62269|NCT02751840|"~     Background. The prevalence of obesity has increased in the last two decades. To maintain body~     weight energy expenditure (EE) should be equal to energy intake (EI). A low EE predisposes~     individuals to weight gain and to obesity that can also results from low resting metabolic~     rate (RMR). Caffeine (Caf) is an active food ingredient and is widely consumed globally, and~     has an important impact on energy balance. Caf reduces appetite (EI) and increases EE, thus,~     Caf has a potential role in body weight reduction. Caf causes higher total daily energy~     expenditure (TDEE) in normal weight (NW) people compared to obese (OW). Moreover Caf is~     linked to decreased fat oxidation in OW. There are differences between OW and NW in Caf~     pharmacokinetics, but no differences reported between NW and OW females in its effects on~     RMR. There is a gender difference in the influence of Caf on metabolism. The investigators~     are aware of no previous studies which compared the effect of Caf on the RMR of NW and OW~     men.~      Objectives. 1) To compare the effect of Caf and coffee on resting metabolic rate (RMR) values~     in healthy normal-weight (NW) men and overweight (OW) men. 2) To develop Caf intake frequency~     questionnaire (in Hebrew)~      Hypothesis. RMR values will be higher and respiratory exchange ratio (RER) values will be~     lower in NW compared to the values measured in OW men.~      Methods. 33 men (16 NW and 17 OW) were reported to the laboratory on 4 separate occasions~     (placebo, Caf tablets, coffee and decaffeinated coffee). During the lab sessions they were~     undergo complete anthropometric measurements and RMR measured (one of the study conditions)~     using indirect calorimetry. Additionally, respiratory exchange ratio (RER) which is~     calculated as the ratio between CO2 production (VCO2) and O2 consumption (VO2) (VCO2/VO2),~     blood pressure and heart rate (HR) response recorded.~      The importance of this study is that the results will contribute to the scientific basis of~     weight control and health interventions programs (diet and physical activity) in overweight~     men.~   "
62270|NCT02751827|"~     In order to assess the important issue of the safety of antiangiogenic TKI in geriatric~     population we set up this project which aims to identify, among clinical, biological,~     pharmacokinetic data, predictive factors for severe toxicity of antiangiogenic TKI~     (sunitinib, sorafenib, pazopanib, regorafenib, axitinib) in patients over 75 year-old.~   "
62271|NCT02751814|"~     Objective is to examine the physical activity and screen-time behaviors of children enrolled~     in licensed childcare centers before and after the enactment of new state regulations.~   "
62272|NCT02751801|"~     Hypophosphatasia (HPP) is a genetic disorder caused by mutation in the tissue-non-specific~     alkaline phosphatase gene (TNSALP). It causes impaired bone mineralisation, fractures, tooth~     loss, muscle weakness and possibly other adverse health outcomes.~      The infantile-onset forms are severe, and were often fatal until the recent availability of a~     treatment (Asfotase Alfa). The childhood-onset forms are less severe, and the adult-onset~     form is mild, and often unrecognised or misdiagnosed as osteoporosis.~      The less severe forms of the disease are not well described, and because there has been no~     available treatment there has not been much research in adults. However, now that treatment~     is available there is a possibility of a clinical trial in adults. To know whether there is a~     need for a trial there is a need to determine if there is a significant personal and economic~     burden associated with the less severe forms of HPP.~      The study consists of a clinical interview and notes review of adults and children with~     confirmed (by biochemical and genetic testing) HPP attending metabolic bone clinics in~     Sheffield to establish their clinical problems and healthcare use. There are currently about~     26 adults and 8 children attending clinics in Sheffield.~      The information will be used to plan a data search and health economic analysis of the burden~     of HPP from the UK Clinical Practice Research Database in collaboration with Pharmatelligence~     (a healthcare data group based within the University of Cardiff).~   "
62273|NCT02751788|"~     The goal of this project is to examine the physical activity and screen-time environment of~     licensed childcare centers before and after the enactment of new state regulations.~   "
62274|NCT02751775|"~     The objective is to establish community priorities for strategies to improve young children's~     health behaviors based on focus groups of stakeholders in the greater Baton Rouge area.~   "
62275|NCT02751762|"~     The purpose of this study is to quantify the serious risks of misuse, abuse, and addiction~     associated with long-term use of opioid analgesics for management of chronic pain, among~     patients prescribed ER/LA opioid products.~   "
62276|NCT02751749|"~     The study uses a replicated randomized single case design. Participants were 12 individuals~     with chronic pain problems and residual problems after undergoing a multimodal pain~     rehabilitation. They also had comorbid emotional problems. Treatment consisted of 10 weeks of~     Internet delivered, therapist guided CBT based self-help treatment based on the Unified~     Protocol.~   "
62277|NCT02751736|"~     The study will investigate whether Probiotics(CJLP243) given just before and after ileostomy~     repair operation in patient with rectal cancer improve a bowel function.~   "
62328|NCT02751047|"~     The investigator will compare the feasibility of manual ventilation and pressure-controlled~     mechanical ventilation during facemask ventilation in children. The hypothesis is that the~     incidence of gastric insufflation would be lower during pressure-controlled mechanical~     ventilation when compared to manual ventilation.~   "
62278|NCT02751723|"~     The aim of this non-investigational study is to determine the symptoms and disease burden at~     the time point of diagnosis and in the further course of an incurable cancer disease. The~     needs and preferences of patients suffering from cancer (ovarian carcinoma, breast cancer,~     malignant melanoma, lung cancer, stomach cancer, oesophageal cancer, pancreatic cancer,~     cancer of the hepatobiliary system, colorectal cancer, head and neck cancer) are examined by~     various validated questionnaires. The data obtained by these questionnaires are collected~     together with information obtained by the treating physicians at four time points during the~     study: t0 - patient´s enrollment, at the moment of diagnosis and before the start of tumor~     therapy, respectively; T1 - 3 months after patient´s enrollment; T2 - 6 months after~     patient´s enrollment; T3 - 12 months after patient´s enrollment. This highly innovative~     project offers the chance to identify medical services deficits and risk circumstances for~     the burden of treatments in an oncology-palliative setting and to optimize the quality of~     patient care.~   "
62279|NCT02751710|"~     This trial is being conducted to determine the impact of whole body FDG PET-CT vs.~     conventional staging in the management of patients presenting with clinical Stage III breast~     cancer. Eligible consenting patients with ductal or mixed histology breast cancer will be~     randomized 1:1 to whole body FDG PET-CT or conventional staging. Eligible consenting patients~     with lobular only histology will be entered into a separate single arm prospective study and~     will undergo whole body FDG PET-CT, CT with contrast of the chest/abdomen & pelvis and a bone~     scan.~   "
62280|NCT02751684|"~     The investigators want to identify and show differences in standards and procedures of~     in-hospital rapid sequence induction by collecting data with an online survey for~     anaesthetist in Europe.~   "
62281|NCT02751671|"~     Background:~      The investigators recently evaluated a new bladder stimulation technique to obtain~     clean-catch urine in infants aged less than six months. In this study, the reported success~     rate was of 52%. Measuring the transversal bladder diameter prior to the procedure with~     emergency point-of-care ultrasound (ePOCUS) could likely increase success rates for this~     technique as it has been described for bladder scans prior to performing urethral~     catheterization.~      Objective:~      The aim of this study is to evaluate if using emergency point-of-care ultrasound to measure~     bladder volume improves clean-catch urine collection success in patients less than 6 months~     of age when compared to children undergoing this technique without a prior ultrasound.~      Methods:~      This will be a randomized controlled trial performed in a tertiary paediatric emergency~     department. Participants will include all infants younger than 6 months of age who need a~     urinary culture and/or analysis requested by the attending physician. The intervention will~     consist of the use of emergency point-of-care ultrasound by a trained research assistant. The~     primary outcome will be the rate of success of the procedure. Secondary objectives will be to~     evaluate time to collect urine samples and to determine which transversal bladder diameter~     correlates with more than a 90% success rate for the procedure. Independent variables will be~     sex and age. In both groups, trained research nurses will collect clean-catch urine samples~     using bladder stimulation techniques. The success rate of the CCU procedure in both groups~     will be calculated. The time required to collect urine samples will be analysed. In group 1,~     the investigators will determine the transversal bladder diameter corresponding to a success~     rate for the procedure of > 80%. It is estimated that, in the worse-case scenario, the~     evaluation of 200 participants will provide a 95% confidence interval smaller than 10% for~     proportions. In addition, 20 participants with a successful CCU sample would allow to~     evaluate 2 risk factors using univariate and multivariate analysis.~      Expected results:~      This study will demonstrate that use of emergency point-of-care ultrasound increases success~     rates of stimulated clean-catch manoeuvres and may avoid invasive urethral catheterizations~     in young children.~   "
62282|NCT02751658|"~     The bacteria live in community and in some cases it is the combination of several~     microorganisms that facilitates transmission and pathogenicity. The concept of pathobiome~     follows from this finding. Investigators hypothesize that the microbial community water point~     is a pathobiome influencing installation and transmission of pathogens associated with care~   "
62283|NCT02751645|"~     The investigators primary objective is to determine if acute normovolemic hemodilution (ANH)~     for pediatric cardiac surgical patients decreases the volume of blood products transfused~     during surgery and the immediate post-operative period as compared to usual care. This study~     will enroll 24 pediatric heart surgery patients, aged 6 months to 3 years old undergoing~     either ANH prior to initiating cardiopulmonary bypass or the standard of care procedures for~     the use of cardiopulmonary bypass.~   "
62284|NCT02751632|"~     A sequential multistage randomised clinical trial (SMART) to produce evidence to guide a~     step-wise clinical approach for the treatment of ultra high risk patients and reduction of~     risk for psychosis and other deleterious clinical and/or functional outcomes.~   "
62285|NCT02751619|"~     Thoracotomy is one of the most painful surgical incision. Uncontrolled acute post-thoracotomy~     pain reducing deep breathing exercises and secretion clearance increased the incidence of~     postoperative pulmonary complications including atelectasis, hypoxemia, and postoperative~     pulmonary infections. Thus, an effective analgesia is crucial in order to reduce~     perioperative morbidity and hospitalization time and also to prevent chronic post-thoracotomy~     pain.~      Thoracic epidural analgesia and thoracic paravertebral analgesia are currently the standard~     strategies for thoracic surgery but the difficult of performing them in all patients and~     their potential complications are all factors that limit their use. Systemic administration~     of opioids is the simplest and common strategy to provide analgesia but it may be associated~     with several undesirable effects, such as respiratory depression, sedation, nausea,~     constipation and vomiting.~      In the recent years, preventive analgesia is become one of the most promising strategy of~     postoperative pain control. It is based on the concept of administering analgesic drugs~     before the occurrence of nociceptive input in order to prevent central sensitization. The~     efficacy of preemptive analgesia is unclear and there is no a consensus on its efficacy on~     controlling pain after thoracic procedure.~      Pain following thoracotomy has a multifactorial genesis including surgical incision,~     intercostal nerve injury, pleural inflammation, and damage of pulmonary parenchyma and of~     diaphragm. Thus, a multimodal analgesia that intercepts the signalizing at numerous locations~     could be more effective than a single strategy targeting one site along the pain pathway.~      Thus, in the present study, the clinical hypothesis was that the preemptive analgesia of the~     skin using a new tool as the Lidocaine patch 5% would improve the analgesic effects of~     systemic morphine analgesia for controlling post-operative pain following thoracotomy.~   "
62286|NCT02751606|"~     This study evaluates the diagnostic accuracy of an USPIO contrast agent (ferumoxtran-10) in~     combination with 7 Tesla MRI to detect lymph node metastases in rectal and breast cancer.~   "
62287|NCT02751593|"~     The project was undertaking by Peking University People's Hospital and other well-known~     hospitals in China. Aims at evaluating efficacy and safety of dexamethasone in management of~     ITP in pregnancy.~   "
62288|NCT02751580|"~     This pilot clinical trial studies how well telehealth works in patients during post radiation~     therapy visits. A telehealth virtual office visit can be performed from the patient's home or~     workplace, decreasing time spent traveling to visit site, time spent in waiting room, and~     cost to patient. Studying telehealth may improve quality of life in patients during post~     radiation therapy visit.~   "
62289|NCT02751567|"~     To evaluate the potential of a test material to produce a photoallergic response.~   "
62290|NCT02751541|"~     To determine the phototoxic potential of a topically applied article in human subjects.~   "
62291|NCT02751528|"~     The purpose of this study is to determine whether ETBX-021 is safe and effective in the~     treatment of unresectable locally advanced or metastatic HER2-low-expressing breast cancer.~   "
62292|NCT02751515|"~     To evaluate the potential of a test material to produce a photoallergic response.~   "
62293|NCT02751502|"~     Twenty pediatric patients aged 5-17 years with Acquired Brain Injuries (ABI) will be~     randomized to receive either a bimanual-to-unimanual device home training program (10~     subjects) or a conventional non-device home training program (10 subjects) for a period of 6~     weeks.~      The specific aims of this proposal are to:~      Aim 1: Introduce home-based targeted upper limb training in children with hemiplegia from ABI~     (Acquired Brain Injuries) using a bimanual-to-unimanual training approach It is hypothesized~     that child-friendly home-based upper limb bimanual-to-unimanual training will lead to greater~     compliance and improved motor outcome on the Fugl Myer Scale compared to a conventional home~     training program.~      Aim 2: Improve the understanding of the pattern of recovery of isolated joint movements in~     the pediatric population with hemiplegia following ABI.~      It is hypothesized that individuals receiving device-based bimanual-to-unimanual training~     will show improvement in active range of motion across upper limb joints compared with a~     conventional home training program.~   "
62294|NCT02751489|"~     To determine the phototoxic potential of a topically applied article in human subjects~   "
62295|NCT02751476|"~     This study builds evidence on the importance of using safe drinking water during the~     nutritional treatment of children affected by Severe Acute Malnutrition (SAM). The following~     hypotheses will be tested: 1.The addition of safe drinking water to SAM treatment will reduce~     exposure to pathogens that cause diarrhoeal disease, thereby reducing diarrhoea incidence~     among enrolled children. 2.Reductions in pathogen exposure and diarrhoeal disease will result~     in shorter recovery pe-riods for children with SAM. The study will evaluate the effectiveness~     of safe drinking water in reducing SAM treatment cost and duration and will provide~     recommendations for improving SAM treatment protocols.~   "
62296|NCT02751463|"~     To evaluate the potential of a test material to produce a photoallergic response.~   "
62297|NCT02751450|"~     This single centre, comparative design study will be used to investigate the efficacy of an~     experimental stannous fluoride containing dentifrice in relieving dentinal hypersensitivity~     (DH) after short term use compared with a standard fluoride dentifrice.~   "
62298|NCT02751437|"~     The investigators will explore the effect of current intravenous feeding (parenteral~     nutrition (PN)) formulations on blood arginine levels and the genes that are involved in body~     nutrition and fighting infection in premature babies. They will also investigate the effect~     of supplementing arginine on these genes. The investigators will undertake a single centre~     exploratory physiological study in 12 very premature infants receiving PN. 4 of these infants~     will be supplemented with arginine. The investigators will record nutritional intake and~     routine biochemical testing data (which includes amino acid levels) collected over the first~     10 days of life. They will take blood for analysis at prespecified intervals for microarray,~     ammonia and IGF-1 levels. Microarray findings will allow the investigators to describe the~     effect of arginine on gene activity in preterm infants.~   "
62299|NCT02751424|"~     A phase I, first-time-in-human (FTIH), randomized, double-blind, placebo controlled,~     dose-escalation study is conducted to determine the safety, tolerability, and pharmacokinetic~     (PK) profile of GSK3342830 after administration of single intravenous (IV) infusion in Part 1~     and repeat IV infusion in Part 2 in healthy subjects. Part 1 will investigate escalating~     single IV doses of GSK3342830. Part 2, will investigate escalating repeat IV doses of~     GSK3342830 with repeat dosing for 15 days as follows: a single IV infusion on Day 1, TID~     (three times a day) IV infusions on Days 2 through 14 (approximately every 8 hours), and a~     single IV infusion on Day 15. The planned starting GSK3342830 dose in Part 1 is 250 milligram~     (mg) administered as a single IV infusion. The dose is planned to increase in subsequent~     cohorts to 500, 1000, 2000, 4000, and less than or equal to (≤) 6000 mg. Part 1 will be~     divided into 6 cohorts (A-F) and each cohort will enroll 10 subjects (6 in active and 2 in~     placebo). Dose escalation will be conducted only if it is supported by the preliminary~     safety, tolerability, and PK results from the preceding dose levels in the study. The repeat~     dose escalation component (Part 2) of this study will be planned to be initiated after~     completion and evaluation of the all single dose cohorts up to and including 4000 mg.~   "
62300|NCT02751411|"~     The study is aimed at the efficacy and safety evalutation of the study treatments through a~     2-weeks study period and the subsequent follow-up-~   "
62301|NCT02751398|"~     This study aims to assess the impact of 24-week treatment of dapagliflozin in type 2~     DM(diabetes mellitus) patients on diastolic dysfunction. Primary endpoint is assessing the~     impact of 24-week treatment of dapagliflozin in type 2 DM patients on subclinical diastolic~     dysfunction assessed by supine bicycle diastolic stress echocardiography. Secondary endpoint~     is assessing the impact of 24-week treatment of dapagliflozin in type 2 DM patients on~     functional capacity, he impact of 24-week treatment of dapagliflozin in type 2 DM patients at~     resting diastolic function. This is single-center, randomized, double-blind,~     placebo-controlled, parallel-arm intervention study.~      This study is planned to evaluate the impact of dapagliflozin on diastolic dysfunction~     assessed. The dose of dapagliflozin will be 10 mg as approved.~      For assessment of diastolic dysfunction, supine bicycle stress exercise echocardiography was~     performed, and changes in diastolic functional reserve, VO2max, exercise time, and maximal~     exercise capacity were assessed before and after treatment. This study will be randomized,~     double blind, placebo controlled, to minimize the risk of bias.~   "
62302|NCT02751385|"~     Investigate the effect of multiple oral doses of nintedanib on the single dose kinetics of a~     combination of ethinylestradiol and levonorgestrel (Microgynon®)~   "
62303|NCT02751372|"~     To determine the phototoxic potential of a topically applied article in human subjects.~   "
62304|NCT02751359|"~     The purpose of this double-blind, placebo-controlled study is to determine the analgesic~     effects of cannabidiol (CBD), a chemical constituent found in cannabis that does not have~     intoxicating effects. The analgesic effects of CBD will be assessed using the Cold-Pressor~     Test (CPT), a laboratory model of pain which has predictive validity for the clinical use of~     analgesics.~   "
62305|NCT02751346|"~     This single-center, cross-sectional survey and sensory examination is conducted to determine~     the prevalence, sensory characteristics and risk factors of PPSP in patients who underwent~     cystectomy at Washington University/Barnes-Jewish Hospital between 2009 and 2015. Based on~     data from other lower abdominal surgeries, the investigators hypothesize that 10-15% of~     patients undergoing cystectomy will develop PPSP.~   "
62307|NCT02751320|"~     This will be a single-centre, randomized, blinded, placebo-controlled, 6-treatment, 4-period~     crossover, incomplete block design, in situ caries study in healthy adults who wear a~     removable bilateral mandibular partial denture. The denture will be modified to accommodate 4~     gauze-covered specimens of human dental enamel (4x3mm) that have been previously~     demineralized in vitro to form either S or low-R lesions (2 specimens of each lesion type~     will be used with each participant). After 14 days of twice daily product use off-site, the 2~     S lesion specimens will be removed at the study site, with the remaining 2 low-R lesion~     specimens removed at the study site after a further 14 days of product use. To determine the~     remineralization ability of the treatments, all specimens will be analyzed by transverse~     microradiography (TMR) and enamel fluoride uptake (EFU), with the S lesions additionally~     analyzed by surface micro hardness (SMH) and the low-R lesions additionally analyzed by~     quantitative light fluorescence (QLF).~   "
62308|NCT02751307|"~     Metformin has been used for alleviating metabolic abnormalities in patients with~     schizophrenia. Until now, the lowest dose of metformin to treat metabolic abnormalities in~     clozapine-treated patients is 1000 mg/d. The aim of this study was to determine whether a~     lower dosage of metformin, such as 500 mg/d, is effective for improving metabolic profiles in~     clozapine-treated patients with pre-existing metabolic abnormalities.~      Methods:~      In this 12-week, randomized, double-blind, placebo-controlled trial, metformin 500 mg/d or~     1000 mg/d or a placebo was prescribed to clozapine-treated patients with schizophrenia having~     pre-existing metabolic abnormalities. The recruited patients underwent physical and~     laboratory evaluations at week-4, week-8, and week-12.~   "
62309|NCT02751294|"~     This study will investigate the effect of Tafenoquine (TQ) 150 mg tablet ageing (dissolution~     profiles) on human exposure of TQ comparing the relative bioavailability of TQ from tablets~     exhibiting different dissolution profiles in healthy subjects. This is a single-centre,~     2-arm, randomized open-label, parallel-group study in healthy subjects. All subjects will~     arrive in the unit approximately 24 hours prior to dosing and will be discharged after the~     72-hour post-dose assessments are completed. Subjects will return for outpatient visits on~     Days 7, 14, 21, 28, and 56 after dosing. A total of 14 subjects (n=7 subjects in each arm)~     are planned to be enrolled. All subjects will receive a single dose of study medication~     (2x150 mg TQ tablets + 30 mg TQ SIL in solution) and participate through a 56-day post dose~     follow-up visit. To enable the application of peripheral microsampling in planned paediatric~     studies, a comparison of the measured pharmacokinetic (PK) exposure via peripheral blood~     collection (via microsampling) to venous collection will also be performed in this study.~   "
62310|NCT02751281|"~     The purpose of this study is to determine which type of percutaneous nephrolithotomy is~     better in large kidney stones~   "
62311|NCT02751268|"~     The purpose of this study is to determine whether bilateral infraorbital and infratrochlear~     nerve block in patients undergoing septorhinoplasty are effective in preventing emergence~     agitation.~   "
62312|NCT02751255|"~     Multiple myeloma (MM) patients who develop bortezomib and lenalidomide-resistant disease have~     a very poor survival of only a median of 9 months, indicating that new agents are urgently~     needed. Recent studies have shown that daratumumab as a single agent is effective and well~     tolerated in these heavily pretreated MM patients. However, approximately 60% of patients do~     not achieve a partial response, and ultimately all patients will develop progressive disease~     during daratumumab therapy.~      The investigators have demonstrated that levels of the target antigen CD38, and expression~     levels of the complement inhibitory proteins CD55 and CD59 determine the susceptibility of~     the MM cells towards daratumumab. In addition, MM cells have lower CD38 expression levels and~     higher levels of CD55/CD59 at the time of progression. Importantly, all-trans retinoic acid~     (ATRA) upregulates CD38 levels and downregulates CD55/CD59 levels on MM cells, both in~     daratumumab naïve cells and in cells that are resistant to daratumumab because of previous~     exposure to this drug. These alterations in expression explain the strong synergy between~     ATRA and daratumumab, both in MM cells derived from daratumumab naïve patients and from~     patients with daratumumab-refractory disease.~      These data form the preclinical rationale for clinical evaluation of ATRA and daratumumab in~     MM patients.~   "
62313|NCT02751242|"~     The study team hypothesizes patients at risk for diuretic resistance can be identified early~     in their Emergency Department (ED) or hospital stay by evaluating their urine sodium and~     potassium concentration after an initial dose of IV loop diuretic. The goal of this pilot~     study is to prospectively study urinary electrolyte excretion and determine patterns of~     diuretic responsiveness. This study would be utilized to power an interventional study which~     aims to study alternative methods of treating patients who are identified as having a poor~     response to diuretics in the ED and hospital. This would be expected to have a significant~     impact on a patient's hospital course, length of stay and adverse events.~   "
62314|NCT02751229|"~     The purpose of the study is to evaluate the efficacy of the group-based intervention 'Honest~     Open Proud' among adolescents with mental illness.~   "
62315|NCT02751216|"~     This study is an interventional, observatory single center trial investigating the functional~     connectivity of the electrical brain activity in high frequency/high density spinal cord~     stimulation in failed back surgery syndrome patients with back and leg pain.~   "
62329|NCT02751034|"~     The purpose of this study is to compare the efficacy and safety of the study medical device,~     Neuramis® Deep Lidocaine and the control medical device, Restylane® PERLANE-L in correction~     of nasolabial folds~   "
62330|NCT02751021|"~     Little is known about potential relationships between sleep apnea, plasma aldosterone and~     diastolic dysfunction which is a very frequent finding among patients requiring permanent~     cardiac pacing. Sleep apnea is often under diagnosed by clinical examination. Confirmation~     tests are expensive and access is limited. A specific algorithm available in a recent~     pacemaker allows assessing breathing variations using minute ventilation sensor, with a good~     agreement between the respiratory disturbance index and polysomnography results for the~     diagnosis of severe sleep apnea.~      The purpose of the study is to examine the diagnostic accuracy of a new pacemaker algorithm~     for the diagnosis of obstructive sleep apnea in patients presenting with diastolic~     dysfunction. The investigators also aim to highlight a correlation between plasma aldosterone~     levels and the severity of sleep apnea, with a reversal effect of ventilation therapy in this~     specific population.~   "
62316|NCT02751203|"~     Unintentional injury is the leading cause of death for young children in the United States~     (U.S.) and is responsible for more child deaths than they next three causes combined, that~     is, homicide, suicide, and cancer. Each year approximately 9,000 children die, 250,000 are~     hospitalized and more than 9,000,000 children are treated in emergency departments for~     preventable injuries. Child and adolescent unintentional injury deaths have not declined to~     the same extent that other diseases have, and resources directed at reducing child injury are~     not commensurate with the burden it poses. More than 50% of these injuries occur in and~     around the home, where young children spend most of their time.~      Unlike diseases such as cancer, there is no need to wait on a cure...there already is one.~     Many of these injuries can be prevented through the use of safety equipment and by following~     safety recommendations. Using known, effective countermeasures can prevent or reduce the~     consequences of a child being injured yet these devices are not routinely utilized. Barriers~     related to identifying hazards, finding credible information and recommendations, and~     obtaining the safety products best-suited to the features of your home make creating a safe~     home challenging for caregivers. Interventions for increasing home safety behaviors have~     ranged from educational materials, health care provider counseling, safety product~     distribution, hands-on experiential learning in a safety resource center--these have all been~     evaluated with varying degrees of effectiveness, however, wide-reaching interventions to~     reach large/substantial caregiver audiences, are needed. Offering tailored safety information~     on multiple topics via a single platform, combined with the ability to acquire safety~     devices, is a more efficient means to reach a large segment of the population and may help~     reduce the aforementioned barriers.~      Thus, there is an urgent need for mobile technologies to reduce barriers by helping parents~     identify injury hazards in their homes, consolidate credible injury prevention~     recommendations, organize information by room or feature, tailor by child age, facilitate the~     acquisition and installation of safety products, encourage and track progress, thereby~     increasing the likelihood that parents accomplish these important life-saving safety tasks.~   "
62317|NCT02751190|"~     In the present study the investigators aimed to investigate the relationship between surgical~     methods and chronic pain in over 20 000 patients who underwent groin hernia repair in Sweden~   "
62318|NCT02751177|"~     RAS genotyping is mandatory for the prescription of anti-EGFR (epidermal growth factor~     receptor) therapies in patients with metastatic colorectal cancer. The standard genotyping is~     assessed on formalin-fixed paraffin embedded tumour tissue. This study compares RAS and BRAF~     genotyping results achieved in analyzing circulating plasma DNA using OncoBEAM™ technique~     with those achieved using the standard genotyping techniques and formalin-fixed paraffin~     embedded samples.~   "
62319|NCT02751164|"~     A retrospective analysis of the Case Mix Programme database to evaluate the association~     between day and time of admission to critical care and acute hospital outcome for unplanned~     admissions to adult, general critical care units in England, Wales and Northern Ireland.~   "
62320|NCT02751151|"~     The study will draw patients from the Transplant Dermatology specialty clinic, where the~     investigators see organ transplant recipients (OTR) for regular screening and serve as a~     regional referral center for this population. Enrollment will be limited to 20 patients.~     Inclusion criteria are organ transplant recipients status, active immunosuppression for at~     least 5 years, and history of at least one NMSC.~   "
62321|NCT02751138|"~     Glioblastoma multiforme (GBM) is the most common primary brain tumor in adults. Despite~     intensive research efforts and a multimodal management that actually consists of surgery,~     radiotherapy and chemotherapy with temozolomide, the prognosis is dismal. The aim of the~     current observational study is to determine immune phenotypes in individual patients with GBM~     at the time of diagnosis and to correlate tumor size, location (imaging), tumor properties~     (isocitrate dehydrogenase - 1 (IDH-1), o6-methylguanine-DNA-methyltransferase (MGMT),~     epidermal growth factor receptor (EGFR) mutation status, etc.) with clinical data, such as~     progression free and overall survival, Karnofsky index (progression free survival~     (PFS),overall survival (OS), Karnofsky score( KFS)), with blood immune phenotypes,~     biomarkers, and immune histochemical results of tumor infiltrating lymphocytes, macrophages,~     myeloid derived suppressor cells (MDSC), etc.. The different immunological phenotypes could~     predict a positive response to specific immunological therapeutic strategies and select the~     individual therapeutic plan for an individual GBM patient.~   "
62322|NCT02751125|"~     This pilot study is aimed to reconstruct atrophied posterior alveolar mandibular ridges using~     biomaterial and autologous bone marrow derived stem cells (BMMSC) and to insert an implant~     into the new bone in a prosthetically guided position.~   "
62323|NCT02751112|"~     This study is a proof of concept that will assess the Predictor's kit performances. The test~     will be performed by several technicians, in immunological laboratories of several sites in~     France.~      In this study, couples of donor / recipient in the frame of a graft of CSH will be~     included.~   "
62324|NCT02751099|"~     Bone disorder is a significant problem in chronic kidney disease (CKD), becoming almost~     universal in stage 5 CKD patients. Besides the healthcare costs, bone disorder is associated~     with life-threatening complications, including fractures and cardiovascular (CV) events.~     Kidney transplantation provides circa 68% decrease in mortality and improves co-morbidity.~     Still, bone disease persists after transplantation.~      The investigators hypothesize that bone-derived hormones can induce CV events in kidney~     transplanted patients. Therefore, early evaluation of the bone health is recommended, and~     prevention of its complications is required. Bone biopsy, an invasive and expensive method,~     is the gold standard for bone disorders diagnosis. Therefore, non-invasive predictors for~     bone disease are necessary. Classical biochemical markers of bone formation and resorption~     have shown a low sensitivity and low specificity. New markers, as fibroblast growth factor 23~     (FGF23), and its cofactor klotho, and sclerostin are promising new markers for predicting~     CKD-associated bone and CV disease after transplantation.~      This study assesses the phenotype of bone disease after transplantation (given by bone~     histology) and its correlation with serum FGF23, klotho and sclerostin, in order to evaluate~     its performance predicting CKD-associated bone and CV disease.~   "
62325|NCT02751086|"~     The overall purpose is to develop and maintain a multi-institutional database comprising of~     information regarding surgical, clinical and oncological features of patients that will be~     treated for gastric cancer with robotic, laparoscopic or open approaches and subsequent~     follow-up.~      The main objective is to compare the three surgical arms on surgical and clinical outcomes,~     as well as on the oncological follow-up.~   "
62326|NCT02751073|"~     The purpose of this study is to learn more about the microbes (bacteria) that live in the~     vagina and the bladder. The investigators are doing this research study to understand the~     relationship between microbes (the microbiome) and the occurrence of urinary tract infection~     following surgical removal of the uterus and pelvic organ prolapse repair. The investigators~     expect Lactobacillus and Gardnerella will be the dominant organisms for most women.~     Non-Lactobacillus dominant microbiome communities will be more common in women who ultimately~     develop postoperative urinary tract infection.~   "
62331|NCT02751008|"~     Low bone mass and osteoporosis are underdiagnosed in childhood in our environment and its~     prevalence is unknown. In most cases they are secondary to chronic diseases that conduct to a~     poor bone health condition and thereby a risk of fracture increased. The aim of this study is~     to identify patients with risk factors for low bone mass and determine their Bone Mineral~     Density (amount of bone) by performing bone densitometry and compared with healthy population~     of the same characteristics. Also the investigators want to evaluate bone quality by~     application of Trabecular Bone Score to images obtained by densitometry. As secondary~     objectives the investigators intend to correlate the data with with clinical variables to~     identify the most important in bone health clinical factors. In addition to measuring bone~     quality and quantity demographic and clinical process related to bone quality base and~     variables will be collected.~   "
62332|NCT02750995|"~     The purpose of this phase I study is to investigate the combination of hypomethylating agents~     with experimental peptide vaccination against four selected tumor antigens, known to be~     upregulated in response to hypomethylating agents, in patients with high risk myelodysplastic~     syndrome and acute myeloid leukemia.~   "
62333|NCT02750982|"~     This is a prospective investigation of the effects of Laughter therapy (LT) on perceived~     stress, self-efficacy, mood and other wellness measures in people with the following~     neurological conditions: Alzheimer's disease, amyotrophic lateral sclerosis, brain injury,~     Huntington's Disease, multiple sclerosis, Parkinson's Disease, post-stroke, spinal cord~     injury.~   "
62334|NCT02750969|"~     The investigators like to learn whether Lidoderm patch (lidocaine 5%) helps tinnitus~     patients.~      so far it is known that lidocaine I.V do helps tinnitus but until now it is not clear if~     other means of drug delivery (e.g lidocaine patch) help tinnitus.~      The investigators are going to compare 1 day of treatment with lidoderm patch cream Versus~     (VS.) tegaderm patch (containing no drug) in treating tinnitus patients.~   "
62335|NCT02750956|"~     The primer aim of the study was to determine serum and gingival crevicular fluid (GCF)~     endocan levels in periodontal diseases pathogenesis supported with vascular endothelial~     growth factor (VEGF) and tumor necrosis factor alpha (TNF-α) levels.~   "
62336|NCT02750943|"~     This will be a single-center, 12 week, examiner-blind, randomized, stratified (gender and~     baseline mean whole mouth MGI score), two-treatment, parallel group, clinical study in~     healthy adult volunteers with moderate gingivitis. This study will evaluate the efficacy of a~     dentifrice containing 0.454% weight by weight (w/w) stannous fluoride to control gingivitis~     and gingival bleeding following 12 weeks twice daily brushing, compared to a negative control~     dentifrice.~   "
62337|NCT02750930|"~     Albiglutide has been developed for the treatment of type 2 diabetes mellitus (T2DM) as an~     adjunct to diet and exercise, as monotherapy, or in combination with existing therapies and~     has been approved by the United States (US) Food and Drug Administration (FDA), the European~     Medicines Agency (EMA) and other regulatory agencies. This is a 26 week, open-label, single~     group, multicenter, extension study to Study 200952. This extension study will provide~     extended safety, tolerability and immunogenicity data for the albiglutide liquid drug~     product. This extension study will comprise 2 study periods: treatment (26 weeks) and~     post-treatment follow-up (8 weeks). A maximum of 300 subjects will be eligible to take part~     in this extension study.~   "
62338|NCT02750917|"~     The purpose of this study is to assess efficacy and safety of lornoxicam compared with that~     of etoricoxib after total knee replacement.~   "
62339|NCT02750904|"~     This purpose of the study is to develop and test a new website to help people who have~     bipolar disorder quit smoking.~   "
62340|NCT02750891|"~     This is a phase 1/2, uncontrolled, open-label, multicenter study in patients with recurrent~     and relapsed diffuse intrinsic pontine glioma, glioblastoma, or grade III or IV glioma.~   "
62341|NCT02750878|"~     The purpose of this study is to determine if addition of a handout to the standard consent~     process for the trans-obturator tape (TOT) mid-urethral sling procedure will improve~     patients' understanding, recall and satisfaction with their procedure. The information~     provided in the handout will include the procedure details, the accompanying risks and~     benefits, as well as the expectations and alternatives to the TOT procedure. The aim of the~     investigators is to improve and standardize the current process for surgical consent for~     patients undergoing a mid-urethral sling procedure, specifically the TOT. The investigators~     hypothesize that addition of a handout will improve patient's preoperative comprehension by~     an absolute value of 10% compared to the standard consent process. The investigators further~     hypothesize that the handout will improve patient satisfaction and recall of the surgical~     procedure details post operatively.~   "
62342|NCT02750865|"~     In this study the investigators will advance research on the development of easy to use~     technologies to empower patients. This is a scalable approach that has a significant~     potential to reduce suffering for palliative care patients and their caregivers. The~     investigators will adapt existing tested empathic conversational agents (ECA) for home-based~     cancer care management and inpatient bedside counseling to provide the following functions:~        1. medication counseling;~        2. physical activity promotion;~        3. symptom management and continual screening for adverse events; and~        4. alleviation of stress and anxiety~        5. spiritual needs assessment; and~        6. advanced care planning.~      Data from the system will be monitored by a health professional, who communicates with~     members of the patient's care team. In this project, this activity will include facilitating~     referral for palliative care services.~      The investigators will conduct pilot studies both at Boston Medical Center and at~     Northeastern University that will test system usability (Northeastern University and BMC) as~     well as interview burden (BMC only).~      The investigators will conduct a Randomized Control Trial (RCT) to evaluate the agent~     technology, comparing usual care (UC) versus usual care plus the agent (UC+ECA) for patients~     21 or older, with a life expectancy of < 1 year, from outpatient clinics at Boston Medical~     Center (BMC). Each subject will be enrolled along with a caregiver surrogate subject. In~     addition to baseline data collection, there will be monthly phone surveys for six months;~     intervention subjects will use the system for a six-month period of time. In addition, the~     investigators will conduct a randomized trial within the intervention group to compare~     subjects getting functions 1-4 (above) versus subjects getting the augmented intervention~     with all six functions. The intervention will include a nurse management interface to monitor~     clinical alerts generated by the system to stimulate interventions by the clinical staff.~   "
62343|NCT02750852|"~     Aim of these study is to create an algorithm, using data from patients that undergoing total~     hip arthroplasty, to predict blood loss after surgery and permit a safe domestic discharge.~   "
62344|NCT02750839|"~     Aim of the study is to analyze results of treatment of proximal humerus fractures with~     mini-invasive technique and plate fixation.~      In all the patients a analysis of presence of osteoporosis will be done, clinical and x-ray~     results will be statistically analyzed to evidence any connection between clinical outcomes~     and osteoporosis.~   "
62345|NCT02750826|"~     This randomized phase III trial studies whether weight loss in overweight and obese women may~     prevent breast cancer from coming back (recurrence). Previous studies have found that women~     who are overweight or obese when their breast cancer is found (diagnosed) have a greater risk~     of their breast cancer recurring, as compared to women who were thinner when their cancer was~     diagnosed. This study aims to test whether overweight or obese women who take part in a~     weight loss program after being diagnosed with breast cancer have a lower rate of cancer~     recurrence as compared to women who do not take part in the weight loss program. This study~     will help to show whether weight loss programs should be a part of breast cancer treatment.~   "
62346|NCT02750813|"~     The purpose of this study is to compare the lens fit characteristics, specifically lens~     centration, of ACUVUE® OASYS® 1-DAY (AO1D) contact lenses and DAILIES TOTAL1® (DT1) contact~     lenses.~   "
62347|NCT02750800|"~     This study aims at evaluate the effect of adalimumab with patient support program (PSP) on~     clinical, health economic, patient reported outcomes in patients with rheumatoid arthritis,~     ankylosing spondylitis, psoriatic arthritis, psoriasis, Crohn's disease and ulcerative~     colitis in the routine clinical setting in Hungary.~   "
62348|NCT02750787|"~     The study is designed to observe the use of a peptide-based oral nutrition supplement in~     adults with chronic malabsorption or maldigestion who require supplemental nutrition as~     assessed by a clinician.~   "
62349|NCT02750774|"~     High pre-pregnancy body mass index (BMI) and excessive gestational weight gain (GWG) are~     associated with many unfavourable maternal and neonatal outcomes.~      Adherence to lifestyle recommendations could be a major determinant of the efficacy on~     preventing unfavorable outcomes, namely among overweight/obese women. Previous studies~     investigated adherence to specific dietary patterns and their effect on pregnancy outcomes;~     however, no study has investigated adherence among overweight/obese pregnant women and its~     effect on the onset of several maternal-neonatal outcomes.~      This study aimed to determine whether the prescription of a lifestyle program, consisting of~     a customized low-glycemic index (GI) diet and a physical activity program, in overweight and~     obese women could affect the occurrence LGA babies. It also aimed to determine whether this~     kind of prescription influences the adherence to healthier eating habits, and how this, in~     turn, can influence the occurrence LGA.~   "
62350|NCT02750761|"~     This is a study to assess the pharmacokinetics (PK) of tedizolid phosphate and its active~     metabolite, tedizolid, and the safety of tedizolid phosphate following administration of a~     single IV (Part A) or oral suspension (Part B) administration to hospitalized participants~     ages 6 to <12 years (Groups 1 and 3, respectively), and 2 to <6 years (Groups 2 and 4,~     respectively).~   "
62351|NCT02750748|"~     To determine the pharmacokinetics of 2 intranasal doses and 1 oral dose of naltrexone~     compared to an intramuscular dose of naltrexone.~   "
62352|NCT02750735|"~     In the last few years, a new clinical entity has emerged which includes patients who consider~     themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though~     they do not have celiac disease (CD) or wheat allergy. This clinical condition has been named~     non-celiac gluten sensitivity (NCGS), although in a recent article, the investigators~     suggested the term non-celiac wheat sensitivity (NCWS), because it is not known to date~     what component of wheat actually causes the symptoms. Nickel is the fourth most used metal~     and the most frequent cause of contact allergy in the industrialized world. As a natural~     element of the earth's crust small amounts are found in water, soil, and natural foods,~     especially plant ones. Nickel allergy not only affects the skin but also results in systemic~     manifestations. Systemic nickel allergy syndrome can have cutaneous (urticaria/angioedema,~     flares, itching), and/or gastrointestinal (meteorism, colic, diarrhoea) signs and symptoms.~     In this study, the investigators evaluated 1) the frequency of Nickel allergy and Systemic~     Nickel allergy syndrome in NCWS patients, and 2) the clinical, serological, and histological~     characteristics of NCWS patients with contact dermatitis Nickel positive in comparison to~     NCWS patients without contact dermatitis.~   "
62353|NCT02750722|"~     The investigators aim to compare a single bout of moderately intense cycling exercise~     incorporating Flutter® breathing maneuvers with a single bout of moderately intense cycling~     exercise alone on sputum viscoelasticity (primary endpoint) and the diffusion capacity of the~     lungs in adult patients with cystic fibrosis.~      The investigators further aim to analyze the short-term variability of resting diffusion~     capacity of carbon monoxide (DLCO) and nitric oxide (DLNO) in patients with cystic fibrosis.~   "
62354|NCT02750709|"~     The purpose of this study is to determine whether Nitisinone 10 mg Tablets (Test Product 1~     (TP1)) and Nitisinone 10 mg Tablets High Compritol (Test Product 2 (TP2)) are bioequivalent~     to the reference product Orfadin 10 mg capsules.~   "
62355|NCT02750696|"~     Aim: The aim of this study was to compare the analgesic efficacy of two combinations of~     opioid and non-opioid analgesics for acute periradicular abscesses.~      Methodology: This study included 24 patients who sought emergency care in a Brazilian dental~     school. The patients were randomly divided into two groups: Codeine/Acetaminophen - oral~     prescription of codeine (30 mg) plus acetaminophen (500 mg), every 4 h, for 3 days or~     Tramadol/Acetaminophen - oral prescription of tramadol hydrochloride (37.5 mg) plus~     acetaminophen (500 mg) on the same schedule. Patients recorded pain scores in a pain diary 6,~     12, 24, 48, and 72 h after treatment, using the Visual Analogue Scale.~   "
62356|NCT02750683|"~     Norepinephrine (NE) is a potent vasopressor used in septic shock to reverse hypotension.~     Early infusion of NE was associated with a favorable clinical outcome in a large cohort of~     patients . When administered early, NE increases cardiac output (CO) in patients with septic~     shock . This effect was suggested to be mainly related to an increased cardiac preload via~     the α-adrenergic-mediated decrease in systemic venous capacitance . Whether NE exerts a~     positive effect on cardiac contractility through β1-adrenergic stimulation is unclear. On the~     one hand, the sensitivity of β1-adrenergic receptors can be abnormally reduced in septic~     conditions. On the other hand, such a sepsis-induced down-regulation of β1-adrenergic~     receptors may occur relatively late and thus, might not be observed when NE is administered~     early. Our study was designed to examine the inotropic effects of NE when administered in the~     early phase of human septic shock~   "
62749|NCT02745535|"~     This study will evaluate the safety, tolerability, and efficacy of~     sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in adults with chronic hepatitis C~     infection who have failed to eradicate hepatitis C despite previous combination directly~     acting antiviral therapy.~   "
62357|NCT02750670|"~     This is a pilot study to determine the overall survival rate and toxicities of obinutuzumab~     given with GDP chemotherapy for relapsed or refractory CD20+ aggressive non-Hodgkin lymphoma.~     Patients who have CD20+ and progressed R-CHOP therapy will be enrolled into the study. About~     30 patients are planned to be enrolled from Princess Margaret Cancer Centre.~      If the enrollment is very slow then additional site may be included. Patients will receive~     Obinutuzumab +GDP for 3 cycles intravenously. CT scan will be used to evaluate the response~     rate after cycle 2 and PET-CT will be used after cycle 3. Responders (complete metabolic~     response, partial metabolic response) should proceed to autologous stem cell transplant~     (ASCT). Patients who have progressed after three cycles or less are to have their protocol~     treatment discontinued, with subsequent treatment at investigator discretion. Patients will~     be followed up to 24 months from transplant done or last chemo. Mandatory tissue submission~     and optional tissue and blood submission are required for the correlative component of this~     study.~   "
62358|NCT02750657|"~     Researchers are looking for better ways of understanding and treating pancreatic cancer. The~     purpose of this study is to see how useful it is to look for changes and characteristics in~     your genes (molecules that contain instructions for the development and functioning of the~     cells) and the genes within the tumour. These characteristics may be useful in choosing~     treatments for patients in the future. Changes (mutations) in genes have been shown to be an~     important characteristic in cancers. Looking at differences in genes in patients with~     advanced pancreatic ductal adenocarcinomas and comparing this information with response to~     their initial chemotherapy treatment may help to learn which treatments may be better for~     certain patients after initial treatment.~   "
62359|NCT02750644|"~     Until the irruption of the Carotid Revascularization Endarterectomy versus Stenting Trial~     (CREST), carotid stenting (CAS) has been mainly offered to those patients considered at high~     risk for open carotid endarterectomy (CEA) based on the available data from large randomized~     clinical trials. High risk has been defined as (1) patients with severe comorbidity (class~     III/IV congestive heart failure, class III/IV angina, coronary disease involving ≥ 2 major~     vessels, left ventricular ejection fraction ≤ 30%, myocardial infarction, severe pulmonary~     disease, severe renal failure) and (2) Technical/challenging anatomical criteria (previous~     neck surgery, cervical irradiation, contralateral carotid occlusion, post-endarterectomy~     restenosis, inaccessible lesions or tracheotomy). Several recent studies have called medical~     high-risk into question for CAS indication.~      The purpose of this study is to evaluate the safety and perioperative and long-term~     effectiveness in patients with significant carotid artery stenosis with high-risk criteria~     (for CEA) treated with carotid stenting and proximal protection device (MOMA®) compared to~     patients with standard-surgical-risk features.~   "
62360|NCT02750631|"~     Depressed patients miss a night of sleep (Wake Night), then sleep at predetermined times~     ending at their desired sleep time. Beginning the morning following their Wake Night,~     patients sit in front of a bright light, continuing morning bright light and specified sleep~     time for six weeks with weekly visits measuring depressive symptoms.~   "
62361|NCT02750618|"~     The primary objectives of the study are to:~        -  Establish the safety profile of KRN23 for the treatment of XLH in children between 1 and~          4 years old~        -  Determine the PD effects of KRN23 treatment on serum phosphorus and other PD markers~          that reflect the status of phosphate homeostasis in children between 1 and 4 years old~          with XLH~   "
62362|NCT02750605|"~     The purpose of this trial is to compare short- medium long-term results in treatment of PAD~     (peripheral arterial disease) in the crural arteries with either drug coated balloon or~     conventional balloons in a prospective , randomized, single center study~      Results will be defined as:~      Limb salvage, Event-free survival, Freedom from TLR (target lesion revascularization),~     Primary patency, Clinical success, Serious adverse events, and the patients will be~     followed-up for 1 years.~      Primary endpoints:~      Primary Patency at 12 months~      Secondary endpoints:~      Event free survival, Clinical success at 6,12 months, Technical success, Serious adverse~     events, TLR (clinical driven),~   "
62363|NCT02750592|"~     Assess the clinical efficacy, safety and tolerability of secukinumab subcutaneous injections~     up to 52 weeks in Japanese patients with active AS despite current or previous non-steroidal~     anti-inflammatory drugs (NSAIDs) and/or anti-tumor necrosis factor (TNF) α therapy. Efficacy~     and safety data will be used to support the registration of secukinumab in Japan for the~     treatment of active AS.~   "
62364|NCT02750579|"~     Percutaneous coronary intervention (PCI) is the cornerstone of the care of intermediate and~     high-risk non ST-elevation acute coronary syndromes (NSTE ACS). Revascularization reduces the~     rate of cardiovascular death and recurrent myocardial infarction in this clinical setting.~     The recommendation regarding the timing of intervention in this clinical setting is derived~     from old trials and has a weak level of evidence. In fact, there are no conclusive randomized~     trials in the contemporary era providing guidance on the optimal timing of intervention. In~     addition, the optimal timing of this critical intervention has not been studied since the~     development of new P2Y12-ADP receptor antagonists and the controversy surrounding the use of~     pretreatment with a P2Y12-ADP receptor antagonist before intervention. Early intervention in~     intermediate and high-risk non ST-elevation ACS is not well validated to date. In addition,~     the recent changes in the use of pretreatment with P2Y12-ADP receptor antagonists may impact~     on the potential benefit of an early intervention.~      Based on these evidences, we hypothesize that with the current protocols of care without~     pretreatment with a P2Y12-ADP receptor antagonist, an early PCI (<2 hours) would be superior~     to a delayed (between 12 to 72 hours) PCI in the setting of intermediate or high-risk non-ST~     elevation acute coronary syndrome to prevent cardiovascular death and ischemic recurrences.~   "
62385|NCT02750306|"~     This study aims to examine the safety and efficacy of suvorexant (MK-4305) to improve sleep~     in individuals with Alzheimer's disease (AD). The primary hypothesis for the study is that~     suvorexant is superior to placebo in improving insomnia as measured by change from baseline~     in polysomnography (PSG)-derived total sleep time (TST) at Week 4.~   "
62386|NCT02750293|"~     Six-hundred subjects with vitamin D deficiency will be randomized to vitamin D 3000 IU per~     day versus placebo for 4 months, with effects on cardiovascular risk factors as main endpoint~   "
62750|NCT02745522|"~     The current study aimed to investigate whether oxytocin (OXT) had effect on placebo~     analgesia.~   "
62365|NCT02750566|"~     Concussion or mild traumatic brain injury (TBI) is a challenging injury for physicians to~     manage and is among the most serious disabling neurological disorders. Physician awareness~     regarding manifestations of TBI and subsequent treatment are paramount to reduce the burden~     of disease. Advancements in treatment of mild TBI have been slow with a lack of consensus on~     treatment methods that show universal success. This gap in treatment choices provides an~     opportunity for osteopathic manipulative treatment (OMT) to fill. OMT is a hands-on manual~     therapy that can be integrated to help treat post-concussive symptoms. Previous studies have~     shown that OMT can help resolve imbalance and tinnitus in elderly populations and case~     studies have shown that this manual therapy may assist in patient recovery. The investigators~     hypothesize that OMT will decrease return to play/work time, will show an improvement in~     balance, and will decrease concussion symptoms as compared to counseling.~   "
62366|NCT02750553|"~     This is a randomized, placebo-controlled, single & multiple dose escalation study to~     investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR0534. The~     study will be conducted with starting dose of 5 mg followed by dose escalation groups up to~     100 mg. Healthy Chinese subjects will be randomized in each cohort to receive the study drug~     or placebo.~   "
62367|NCT02750540|"~     DREAM-01 is an early phase 1, open label, dose-escalation and variable osmolarity study to~     compare the safety, pharmacokinetics (PK), pharmacodynamics (PD), and acceptability of 3~     formulations of a tenofovir (TFV) enema. The goal of the study is to identify the dose and~     osmolarity of a TFV enema for human immunodeficiency virus (HIV) pre-exposure prophylaxis~     (PrEP) which achieves the desired colonic mucosal mononuclear cells (MMC) tenofovir~     diphosphate (TFV-DP) target concentrations that have previously been shown to confer~     protection from HIV acquisition in men who have sex with men (MSM).~   "
62368|NCT02750527|"~     This is a Pilot/ feasibility study for a population-based Screening in all children 2 to 6~     years in Lower Saxony, Germany during the compulsory (U7 (from the age of 2) U7a, U8, U9)~     routine check-ups and any voluntary visits to the pediatricians office.~   "
62369|NCT02750514|"~     The purpose of this study is to determine whether Nivolumab, in combination with other~     therapies, is effective in patients with advanced Non-Small Cell lung cancer~   "
62370|NCT02750501|"~     Protocol 0000498 is a multi center, open label study to evaluate the safety, tolerability and~     fat absorption of sustained Relizorb (immobilized lipase cartridge) use for patients with~     cystic fibrosis and exocrine pancreatic insufficiency who receive enteral tube feeding.~   "
62371|NCT02750488|"~     To evaluate the potential of a test material to produce a photoallergic response.~   "
62372|NCT02750475|"~     To determine the phototoxic potential of a topically applied article in human subjects~   "
62373|NCT02750462|"~     The aim of the trial is to compare immediate angiography in survivors of out of hospital~     cardiac arrest (OHCA) without ST-segment elevation versus delayed/selective catheterization~     with respect to 30 day mortality.~      The TOMAHAWK trial is supported by the Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK).~   "
62374|NCT02750449|"~     To evaluate the potential of a test material to produce a photo allergic response.~   "
62375|NCT02750436|"~     Sacral lateral branch blocks are used for the diagnosis and treatment of sacroiliac joint~     pain. This study will compare ultrasound and fluoroscopy guidance for sacral lateral branch~     blocks. Outcomes examined will include performance times and success rates.~   "
62376|NCT02750423|"~     Investigators are seeking to learn how well different cooling temperatures along with~     different blood flow pathways to the brain reduce the risk of injury to the brain in~     participants planning to undergo elective aortic arch and hemiarch surgery. Participants will~     be randomized to receive a cerebral protection strategy of either: deep hypothermic~     circulatory arrest and retrograde cerebral perfusion (DHCA+RCP) or moderate hypothermic~     circulatory arrest and unilateral selective antegrade cerebral perfusion (MHCA+uSACP).~     Evidence of neurologic injury will be assessed with neurologic exams, neurocognitive tests,~     MRI imaging of the brain and measurement of plasma S-100 levels during post operative follow~     ups.~   "
62377|NCT02750410|"~     The main purpose of this study is to evaluate the efficacy and safety of combination therapy~     with dulaglutide and insulin in Japanese participants with type 2 diabetes.~   "
62378|NCT02750397|"~     HIV-infected (HIV+) individuals who agree to accept and receive a solid organ transplant from~     an HIV+ deceased donor will be followed to determine the safety and efficacy of this~     practice. HIV+ individuals who receive a solid organ transplant from HIV-uninfected donors~     will also be followed.~   "
62379|NCT02750384|"~     This is a single-dose, fasting and non-fasting, open-label, randomized, three-regimen,~     parallel group study in 42 subjects~   "
62380|NCT02750371|"~     Several studies showed that radiotherapy as brain tumors treatment may affect cognition. It~     was observed that durable memory impairments could arise at irradiated patients if~     radiotherapy is applied on medial temporal lobes.~      However, results concerned studies of anterograde memory and none, this day, estimates the~     impact of radiotherapy on autobiographical memory which also involves hippocampus.~      The aim of this study is to evaluate effects of cavernous sinus or sellar region irradiation~     on autobiographical memory.~      Thirty 35 to 65 years old patients, with cavernous sinus meningioma or pituitary adenoma for~     who radiotherapy is indicated will be recruited.~   "
62381|NCT02750358|"~     This trial is designed to determine the feasibility of 1 year of adjuvant enzalutamide, an~     androgen receptor (AR) antagonist for the treatment of patients with early stage, AR(+)~     triple negative breast cancer (TNBC).~   "
62382|NCT02750345|"~     The purpose of this study is to determine whether Nitisinone 10 mg Tablets (Test Product 1)~     and Nitisinone 10 mg Tablets 'Baked' for 6 months @ 40°C/75% RH (Test Product 2) are~     bioequivalent to the reference product Orfadin 10 mg hard capsules.~   "
62383|NCT02750332|"~     The purpose of this study is to compare the bioavailability of the Test Product, Nitisinone~     10 mg Tablet, under fasting and fed conditions (food-effect).~   "
62384|NCT02750319|"~     This trial will be comparing the combination of amiodarone and NAC (n=122) to amiodarone~     alone and NAC matched placebo (n=122) to determine the rates with which sustained (lasting~     >30 seconds) or clinically significant POAF is reduced in high risk patients within 7 days~     after major thoracic surgery.~   "
62387|NCT02750280|"~     This ia a prospective controlled longitudinal study to evaluate the effects of MatriStem®~     plus standard local wound care versus standard local wound care alone in the treatment of~     diabetic foot ulcers (DFUs), as assessed by incidence of complete wound healing by 16 weeks~     and ulcer recurrence with a 2 year follow-up.~   "
62388|NCT02750267|"~     The overall aim of this proposed research is to determine the safety, feasibility and~     efficacy (AP vs at home use of SAP) of the Diabetes Assistant (DiAs) controller in day and~     night closed-loop control in young children 5-8 years old with type 1 diabetes over multiple~     48 hours in an out-patient setting.~   "
62389|NCT02750254|"~     Allogeneic hematopoietic cell transplantation (allo-HCT) is a potentially curative therapy~     for patients with hematologic malignancies including acute myeloid leukemia (AML),~     myelodysplastic syndrome (MDS), and acute lymphoblastic leukemia (ALL); however, human~     leukocyte antigen (HLA)-matched donor availability continues to be a major hurdle.~     Historically, HLA haploidentical donor hematopoietic cell transplantation (haplo-HCT) was~     associated with high incidences of graft rejection and excessive non-relapse mortality (NRM),~     but recent advances utilizing post-transplant cyclophosphamide (PT-Cy) have revolutionized~     haplo-HCT and the outcomes are now comparable to allo-HCT using more traditional HLA matched~     related and unrelated donors. However, graft-versus-host disease (GvHD) continues to be a~     problem and is associated with significant morbidity and mortality in allo-HCT patients~     including those who receive haplo-HCT on PT-Cy platform. The aim of this early phase study is~     to investigate the safety and overall efficacy of azacitidine in reducing the incidence and~     severity of GvHD when added to PT-Cy based haplo-HCT platform for patients with AML, ALL, or~     advanced MDS.~   "
62390|NCT02750241|"~     Breast cancer survivors, from diagnosis until the end of life, go through many transitions.~     One major transition is the significant decrease of physical activity immediately after~     diagnosis. Despite the known benefits of physical activity—speeding recovery time and reduced~     cancer recurrence risk—only 1 in 3 survivors met physical activity recommendations of 150~     minutes of moderate-intensity activity per week. Physical activity interventions have shown~     effectiveness in helping breast cancer survivors increase physical activity during treatment,~     but limited evidence-based physical activity interventions have been incorporated into the~     clinic and community. To address this limitation, the investigators are partnering with the~     UTMB breast cancer support group to conduct a 12-week physical activity intervention, Pink~     Warrior.~      The goal of this study is to compare an intervention that uses active games versus an~     intervention uses pedometer to encourage physical activity such as walking within breast~     cancer survivors in active cancer treatment. The study will include breast cancer survivor~     between the ages of 18 - 70 whom currently gets less than 150 minutes of planned physical~     activity per week and received a breast cancer diagnosis within 0 to 6 months. Participants~     will be randomized to participate in the support group using the active video game-based~     physical activity intervention (Wii and Xbox active games) or to participate in the existing~     UTMB breast cancer support group with pedometers (Digi-Walker CW-700/701). The investigators~     hypothesize that by engaging in active video gaming, breast cancer survivors will be~     motivated to initiate and maintain physical activity during treatment. This will ultimately~     increase functional capacity and prevent functional disability in breast cancer survivors.~   "
62391|NCT02750228|"~     The purpose of this study is to track post-discharge outcomes on prematurely born infants who~     are discharged from the NICU with a patent ductus arteriosus (PDA). Investigators plan to~     report on the spontaneous closure rate as well as the incidence of pulmonary and/or cardiac~     events in these infants. The goal is to identify risk factors associated with adverse~     outcomes in prematurely born infants who are sent home with a PDA.~   "
62392|NCT02750215|"~     This research study is studying capmatinib as a treatment for advanced non-small cell lung~     cancer with MET exon 14 skipping, where the participant has already received prior therapy~     with a MET inhibitor.~   "
62393|NCT02750202|"~     Large genital warts are frequently diagnosed in general gynaecology and oncology clinics in~     South Africa. Medical and destructive therapy for small warts is generally very effective,~     however unique problems posed by large or extensive genital warts are not so easily solved~     and treatment of affected patients remains very challenging. Recurrences are common~     especially among immune-compromised women. This study will test whether giving the~     quadrivalent human papilloma virus (HPV) vaccine to women with extensive genital warts prior~     to surgical treatment will improve outcomes. Investigators hypothesize that pre-treatment~     with HPV vaccine can play a role in the control of both malignant and benign HPV disease in~     women with and without HIV infection through stimulation of the antibody response. In~     addition, HPV types and other associated diseases will be studied in women receiving HPV~     vaccine and placebo.~   "
62394|NCT02750189|"~     The purpose of this study is to estimate a direct/indirect medical cost and to provide~     evidence establishing efficient strategies to reduce medical costs of COPD in Korea.~   "
62395|NCT02750176|"~     A single arm design will be used to assess the feasibility and preliminary efficacy of a~     closed-chain rehabilitation protocol for patients with full thickness rotator cuff tears of~     the shoulder. Full thickness rotator cuff tears will be documented using MRI or ultrasound~     images. 30 participants will be recruited for this study. The rehabilitation protocol will~     include two stages: stage 1, physical therapy, and stage 2, gym program. Stage I will include~     a total number of session between 12 and 24. The number of session included in stage 2, will~     depend on the total number of session completed during stage 1. The total duration of both~     stages will 5 months.~   "
62396|NCT02750163|"~     The aim of this study is to evaluate the effect of Acetaminophen on the main parameters of~     microcirculation, on the plasmatic levels of free hemoglobin/oxidative stress markers and on~     the expression of PD1/Pd-L1, in pyrexial septic patient.~   "
62419|NCT02749864|"~     The hypothesis of this investigation stresses that the current understanding of the~     prevalence of HCV infection in the general population and in different subgroups will serve~     to lay out medium- and long-term measures for action geared toward reducing the disease~     burden through preventive, research, screening and therapeutic measures.~      Aim: To determine the prevalence of seropositivity and chronic infection with the HCV and to~     analyze the associated factors. To analyze and infer different screening strategies for HCV~     infection based on the at-risk groups/cohorts of elevated prevalence detected.~   "
62397|NCT02750150|"~     Knowledge and management of bleeding in severe trauma has changed. A specific coagulopathy is~     present in 40% of cases. It has a very early onset and this coagulopathy is associated with~     increased mortality. It must be detected and treated early, as illustrated by the military~     medical data, from the Iraq war and civilian medicine. However, fresh frozen plasma (FFP)~     requires a thawing step.The French army has encouraged the development of a freeze-dried~     plasma of innovative because viral inactivation and universal blood grouping, well tolerated,~     with a reduced risk of TRALI. This sophisticated therapeutic product can be administered~     after 6 minutes of reconstitution without the need for cross-matching. Nevertheless, its used~     is currently reserved for military purpose in overseas operations and needs to be evaluated~     for civil use. To this end, the investigators need to evaluate the impact on coagulopathy of~     an immediate availability of plasma.~   "
62398|NCT02750137|"~     Ametop was introduced into the formulary as it was deemed more efficacious for intravenous~     cannulation compared to EMLA. However, the incidences of adverse reactions seemed to be~     higher compared to other studies. This lead to a prospective observational study to look at~     the incidence and severity of skin reactions following routine clinical application of~     Ametop.~   "
62399|NCT02750124|"~     The main purpose is to develop and test an IT-infrastructure to provide more individualized~     ways of inviting and reaching women who have not participated, despite having been invited~     with annual reminders, in cervix cancer screening program during a ten year period.~   "
62400|NCT02750111|"~     Determine the incidence of hypoglycemia during / after sexual intercourse among young adults~     with type 1 diabetes using continuous -type sugar meter IPRO for a week.~   "
62401|NCT02750098|"~     Comparison of aqueous and plasma glucose level in diabetic patients~      High glucose concentrations in aqueous humor are thought to be related of diabetic ocular~     injury, including cataract and diabetic keratopathy. The primary mechanisms are nonenzymatic~     glycation, oxidative stress and activation of polyol pathway. However, glucose concentrations~     in aqueous humor of diabetic patients was only examined in a few patients in the past.~      This study will compare glucose concentration in blood plasma and aqueous humor in diabetic~     patients undergoing cataract surgery. Perioperative Hemoglobin A1c concentrations will also~     be examined. Correlation between these parameters will be analyzed.~   "
62402|NCT02750085|"~     This is an investigator-initiated, industry-funded, multi-centre, international study that~     will be carried out prospectively at hemophilia treatment centres across Canada, the Czech~     Republic and Australia with SickKids as the coordinating site. The study will use a central~     laboratory not directly affiliated with any of the participating sites. Enrollment target is~     50 participants, both adult and pediatric with severe hemophilia A receiving Advate, who will~     each complete a 2-point and 6-point pharmacokinetic (PK) sampling. The main aim is to compare~     the results of a 2 sample PK using clinically practical time points and myPKFiT™ (a~     web-based, population PK Bayesian tool) to a 6 sample population PK to determine whether the~     results obtained are in good agreement.~   "
62403|NCT02750072|"~     This study will investigate the incidence and severity of anterior knee pain comparing two~     different approaches to tibial nail fixation; Infrapatellar versus percutaneous semi-extended~     suprapatellar incisions. Half the patients will be randomized to the gold standard~     infrapatellar approach with the other half being randomized to treatment with the~     percutaneous semi-extended suprapatellar approach.~   "
62404|NCT02750059|"~     Primary objective: To compare telmisartan therapy + antiretroviral therapy (ART) versus ART~     alone during acute Human Immunodeficiency Virus (HIV)a infection in reducing systemic immune~     activation and trafficking of activated and HIV-infected cells to the central nervous system~     (CNS), and limiting establishment and persistence of the CNS reservoir of HIV.~      At 48 weeks (during the telmisartan therapy) and 72 weeks (~6 months after cessation of~     telmisartan augmentation), the investigator expect subjects in the telmisartan group will~     have reduced levels of blood and CSF immune activation markers, reduced brain inflammation,~     lower CSF HIV ribonecleic acid (RNA) and improved neuropsychological testing performance.~      Secondary objective: In subjects who are willing to undergo the optional inguinal lymph node~     biopsy, the study will determine whether subjects receiving telmisartan plus ART for 48 weeks~     develop less lymphoid tissue fibrosis than subjects receiving ART alone for 48 weeks.~      Subject population: Male and female subjects age ≥ 18 years old with acute HIV infection who~     are identified and enrolled in SEARCH 010/RV254 protocol will be asked to co-enroll in this~     study.~      Number of subjects: 21~      Duration of follow-up: 72 weeks~      Study design: 21 acutely HIV-infected subjects will be randomized 2:1 to treatment with~     telmisartan + ART (n=14) vs. ART alone (n=7) for the first 48 weeks followed by ART alone in~     both arms to week 72. Blood and CSF, magnetic resonance imaging (MRI), and neuropsychological~     testing and exam will be collected at baseline, week 48 and week 72. Inguinal lymph node~     biopsy is an optional procedure that will be offered at baseline and week 48.~   "
62405|NCT02750046|"~     RATIONALE: Collecting and storing bone samples from patients with osteoporotic and~     nonosteoporotic fracture to study a special vessel subtype in the laboratory may help surgeon~     learn more about the relationship between bone mineral density (BMD) and a special vessel~     subtype (type H vessel).~      PURPOSE: This research study is looking at changes of a special vessel subtype in bone~     samples from patients with osteoporotic and nonosteoporotic fracture.~   "
62406|NCT02750033|"~     The research team will develop an intraoperative handheld device for assessing surgical~     margins during Mohs surgery. The device technology is based on multimodal optical~     spectroscopy (MMS), combining three optical spectroscopy techniques into one device. The~     researchers will first acquire proof of concept MMS measurements within the Mohs surgery~     suite immediately after surgical excision and prior to histological processing. MMS~     measurements will be acquired directly on the patient from the NMSC excision site. The final~     outcome of this study will result in the sensitivity and specificity of MMS compared to~     histopathology during Mohs surgery. These results will allow for the estimation of the~     potential benefit of an intraoperative margin assessment technique.~   "
62420|NCT02749851|"~     The purpose of this study is to test the application of newly generated magnetic resonance~     imaging (MRI) protocols for the assessment of placental perfusion in human subjects. The~     primary objective is to validate and establish the utility of placental MRI in pregnant~     women. The study will be entirely MRI-technology based with collection of placental tissue at~     the time of infant delivery for later correlative studies.~   "
62407|NCT02750020|"~     Current study is the fourth wave of the policy-related survey on tobacco control in Hong~     Kong. It aims to investigate the level of public support on current and future tobacco~     control measures and taxation policies and to address the timely impacts of smoke-free~     policies, substantiate public support on further tobacco control measures and assist COSH in~     shaping policy direction for government. In total, 5000 subjects will be randomly selected~     for a telephone interview. The subjects will be categorized into three groups, i.e. never~     smokers (1667), ex-smokers (1667) and current smokers (1667). They will be required to answer~     a questionnaire via telephone. All data shall be collected using a Computer Assisted~     Telephone Interview (CATI) system, which allows real-time data capture and consolidation. All~     interviews shall be conducted anonymously. Analysis of survey data will aim to identify~     current opinion on tobacco control policies and implications for future policies. Analyses~     will be controlled for confounding variables as required by stratification into sub-groups~     based on important pre-defined characteristics and/or by multivariate analysis. Comparison~     with past trends and, where possible, extrapolation of future trends will be explored.~     Weights will be applied to adjust for the sex and age of Hong Kong population, and to handle~     the over-sampling issues of current smokers. The data analysis will be conducted by~     statisticians.~   "
62408|NCT02750007|"~     This study is conducted in China. The aim of this trial is to assess the tolerability to~     HS-20004 with titration administration in type 2 diabetic patients.~   "
62409|NCT02749994|"~     A phase Ⅲ, multi-center, randomized, double-blinded, active comparator, factorial design~     clinical trial to compare the efficacy and safety of a combination therapy of ezetimibe and~     rosuvastatin versus monotherapy of rosuvastatin in hypercholesterolemia patients.~   "
62410|NCT02749981|"~     Pharmacokinetics of cefazolin in children undergoing cardiac surgery.~   "
62411|NCT02749968|"~     This is a study of liposomal bupivacaine for pain control in patients with blunt chest wall~     trauma.~   "
62412|NCT02749955|"~     This study evaluates the feasibility (reach, adoption, safety and implementation) and initial~     efficacy (higher linkage to care) of the Partner Services Pre-exposure Prophylaxis (PS-PrEP)~     intervention versus phone based Pre-exposure Prophylaxis (PrEP) treatment at 3 months post~     randomization among a sample of high risk individuals 18 - 35 years from clinic-based~     recruitment and internal referrals from social network based projects. The evaluation of the~     intervention will be used to strengthen routine department of public health services linkage~     to PrEP care.~   "
62413|NCT02749942|"~     Objective The objective of this study is to investigate if long-term ambulatory remote~     ischemic conditioning can improve symptoms and signs of peripheral arterial disease in~     patients with type 2 diabetes.~      Background Peripheral arterial disease (PAD) is a vast socioeconomic challenge in the~     community of diabetes patients, causing foot ulcers and lower extremity amputations. The main~     treatment option for the complication is operative revascularisation. Thus there is a need~     for new treatment modalities for diabetes patients with PAD.~      Remote ischemic conditioning (RIC) is at non-invasive non-pharmacological treatment which has~     been shown to attenuate tissue damage caused by ischemia e.g. in hearts subjected to~     ischemia. RIC treatment consists of brief repetitive periods of ischemia induced in an~     extremity e.g. an arm. Recent findings show that six week RIC treatment improves healing of~     diabetic foot ulcers, suggesting a possible effect on the underlying pathological causes of~     ulcers e.g. PAD.~      Hypothesis The investigators hypothesize that RIC treatment can improve markers of~     inflammation, vascular and neuronal function and the sense of empowerment in type 2 diabetes~     patients with reduced peripheral blood supply.~      Aim to conduct a single center double-blinded randomized placebo controlled study~     investigating the efficacy of home based 12-week RIC treatment on markers of vascular,~     neuronal function, inflammation and serum lipid composition in 40 type 2 diabetes patients~     from Steno Diabetes Center with non-critical PAD.~      to qualitatively investigate the experience of empowerment related to the use of Remote~     Ischemic Conditioning (RIC) treatment and the mechanisms affecting if and how participants~     take up the RIC treatment.~   "
62414|NCT02749929|"~     Approximately 15,000 persons in Norway suffer from a wrist fractures during a year, making it~     the most prevalent fracture in this country. Treated conservatively, a cast is used for 4-6~     weeks before removal. After discontinuation of the cast, physiotherapy is implemented to aid~     in improving range of motion and regaining function of the injured wrist. The pain after~     injury can affect the patient to a greater or lesser extent, and it is common to prescribe~     sick leave for shorter amounts of time after the injury.~      Studies suggest that a physiotherapy intervention with Low Level Laser therapy (LLLT) may~     reduce pain and swelling after acute trauma, and potentially promote healing. The aim of this~     study is to evaluate the effect of LLLT on pain and function at 2, 4, 8 and 26 weeks after~     injury.~   "
62415|NCT02749916|"~     This study aims to compare image-based characteristics of carotid walls between symptomatic~     side and the opposite side. The design of this study is phase IV, prospective observational~     study.~   "
62416|NCT02749903|"~     This study will test any good and bad effects of the study drug called enzalutamide.~     Enzalutamide could shrink the cancer but it could also cause side effects. Researchers hope~     to learn if the study drug will shrink the cancer by at least 30% compared to its present~     size, in at least 1 out of 5 patients. Enzalutamide is not FDA approved to treat salivary~     gland cancer, but it has already been FDA-approved to treat other cancers.~   "
62417|NCT02749890|"~     Primary Objective:~      To compare LixiLan to lixisenatide in glycated hemoglobin (HbA1c) change from baseline to~     Week 26 in patients with type 2 diabetes mellitus.~      Secondary Objective:~      To compare the overall efficacy and safety of LixiLan to lixisenatide (with or without OADs)~     over a 52 week treatment period in patients with type 2 diabetes mellitus.~   "
62418|NCT02749877|"~     Cancer survival comes at a price: pediatric cancer survivors have a high risk for a wide~     range of cognitive difficulties, particularly survivors of cancer involving the central~     nervous system (CNS, e.g., brain tumors [BT]) are prone to neurocognitive impairments in~     areas such as executive functions, working memory, attention, memory, visuospatial and motor~     skills, processing speed as well as language. The aim of this interdisciplinary longitudinal~     study is to extend empirical knowledge on training and transfer effects in children with a~     history of cancer. It is hypothesized that early cognitive and physical interventions affect~     the remediation of pediatric cancer survivors in terms of cognitive functions. These changes~     are further hypothesized to be associated with white matter changes.~   "
62421|NCT02749838|"~     Purpose of the Protocol:~        -  To prospectively identify cancer patients whose tumors express specific molecular~          markers targeted by therapeutic agents, for the purpose of selecting the most clinically~          appropriate anticancer therapy, including clinical trial opportunities.~        -  To collect and analyze biospecimens from cancer patients, using primarily standard of~          care laboratory methods, for the purpose of determining the expression of specific~          genotypic and phenotypic disease markers of scientific and medical interest.~        -  To create a protocol database, including case and disease stage-matched clinical and~          therapeutic history data in addition to patient biomarker profiles, to serve as:~             -  a systematic collection of data for comparing patient data to clinical trial~               selection criteria for the purpose of informing a clinical investigative site of~               available clinical trials matching patient clinical status;~             -  a collection of clinically matched, comprehensive molecular results for scientific~               and research and development applications.~   "
62422|NCT02749825|"~     This research study looks at Testosterone levels in patients receiving Trelstar versus those~     receiving Lupron or Zoladex. These drugs have been approved for treatment of Prostate Cancer~     by the FDA.~   "
62423|NCT02749812|"~     The investigators propose a multicentric controlled randomized trial whose goal is to~     evaluate the possibility of a prediction of the efficiency of APAP (automatic continuous~     positive airway pressure) and constant CPAP (constant positive airway pressure) in 800 severe~     obstructive sleep apnea syndrome (OSAS) patients according to their profile of pressure~     variability.~   "
62424|NCT02749799|"~     The purpose of this study is to assess patient satisfaction when DFD-01 is used topically~     twice a day for moderate plaque psoriasis.~   "
62425|NCT02749786|"~     Rosacea is a common disease characterized by inflammation and vascular abnormalities of the~     facial skin and ocular surface. It it considered to be a syndrome encompassing various~     combinations of cutaneous signs including flushing, erythema, telangiectasia, papules, edema,~     ocular lesions, and rhinophyma. The exact etiology of cutaneous rosacea is unknown but is~     characterized by persistent vasodilation, increased vascular permeability, and vascular~     hyper-reactivity of the microcirculation of the central part of the face. The purpose of this~     study is to develop gene expression profiles of papulopustular rosacea compared to those of~     normal skin. The investigator hopes to better understand the abnormal gene functions that~     might contribute to this condition. This understanding may lead to the development of~     additional and better treatments for rosacea.~   "
62426|NCT02749773|"~     The aim of this study is to determine whether different needle gauges influences the quality~     of the aspirated oocytes during in-vivo fertilization (IVF).~   "
62427|NCT02749760|"~     This is a study of the muscle stabilizers of the elbow with respect to the prevention of~     Ulnar Collateral Ligament (UCL) injuries in pitchers. Pitchers are assessed at spring~     training and end of season for approximately 5 years. Pronator, flexor digitoum superficialis~     (FDS), and wrist flexion strength will be measured and correlated with upper extremity~     injuries and time missed from pitching. The investigators will also be measuring loss of~     strength over the season. The goal is to learn whether strength in these muscles prevents UCL~     injuries and finally whether these muscles can be strengthened to avoid such injuries.~   "
62428|NCT02749747|"~     -  Introduction: Estrogen hormonal therapy associated or not with progestagen is the~          standard therapy for the treatment of hot flushes. However some women are not candidates~          for hormone replacement therapy for medical reasons or for choice.~        -  Main goal: Reducing the number of hot flushes per week~        -  Materials and Methods: A double-blind sulpiride versus placebo that includes selected~          randomized patients which show symptoms of menopause. Study conducted at Hospital de~          Clínicas de Porto Alegre (Brazil) for 8 weeks of intervention. The expected result is a~          significant reduction in the number of hot flushes / day evaluated by daily~          questionnaires~   "
62429|NCT02749734|"~     The purpose of this study was to determine the safety and therapeutic effect of sub-retinal~     transplantation of human embryo stem cell derived retinal pigment epitheliums (hESC-RPE) in~     patients with macular degeneration diseases, and explore new treatment modalities for macular~     degeneration diseases (Age-related macular degeneration and Stargardt's macular dystrophy).~   "
62430|NCT02749721|"~     The purpose of this study is to explore patterns of Brain Network Activation (BNA) changes~     from baseline to endpoint on 1) efficacy of core symptoms of Major Depressive Disorder (MDD)~     and 2) improvement of cognitive dysfunction with acute treatment with flexible dose~     vortioxetine in adult outpatients with MDD and subjective complaints of cognitive~     dysfunction.~   "
62431|NCT02749708|"~     The purpose of this study is to evaluate the use of IRX5183 in 1) patients with relapsed~     and/or refractory AML and 2) patients with high-risk MDS or chronic myelomonocytic leukemia~     (CMML).~   "
62432|NCT02749695|"~     The placental drug Melsmon® is effective for correction of insomnia and other climacteric~     symptoms in premenopausal women. Decrease of MMI is shown both in groups with Melsmon® and~     Placebo, but it was more significant in patients who used Melsmon®.~   "
62433|NCT02749682|"~     The purpose of this study is to asses the effect of chronic constipation on formation of~     inguinal hernia using Constipation Severity Scale.~   "
62448|NCT02749487|"~     Neutrophil lymphocyte ratio NLR is an important index that evaluate the inflammatory status .~     It is a cost effective and readily available , and simply calculated , so that why~     investigators try to use it as a predictor of short term survival in the critically ill~     patients~   "
62449|NCT02749474|"~     The objective of this study is to follow the treatment options offered to pregnant women~     diagnosed with cancer and study the impact that their treatment or delay of treatment has on~     their own health and that of their children.~   "
62450|NCT02749461|"~     The aims of this validation study are the testing of the Bernese Pain Scale for Neonates'~     (BPSN) psychometric properties. The variability of pain reactions related to behavioral and~     physiological patterns across time will also be examined. Furthermore, the influence of~     contextual factors on the variability of pain reactions across gestational age groups will be~     explored. The results will be used for modifications of the BPSN to account for contextual~     factors in future clinical pain assessment in neonates.~   "
72519|NCT02617732|"~     The purpose of this study is to evaluate the effects and safety of Tianqi Capsule on glucose~     variability in patients with type 2 diabetes by continuous blood glucose monitoring system.~   "
62434|NCT02749669|"~     For almost 17 % of cases patients over 75 years are sent for inappropriate reasons to the~     emergency unit. They are described as inappropriate hospitalization because they don't~     require the use of technical platform or diagnostic neither therapeutic procedures under~     medical supervision. Those are inappropriate because the patient could have a paramedical and~     social care at home or in more efficient structures. The hospital remains the place of remedy~     for social and health situations whose resolution was not possible because of a lack of~     infrastructure available, of patient or his relative information, or a lack of coordination~     in medico-social establishment.~      These inappropriate hospitalizations involve an increase of length of stay that enhancing the~     fragility and vulnerability of the elderly. They have deleterious effects as decompensation,~     comorbidities and loss of autonomy.~      Moreover, the suffering of natural or informal caregivers is also an important public health~     question; Caregivers may have a serious disease resulting from caring their relative. That~     leads to increase their consumption of health care and medical goods.~      This comprehensive study will highlight the deficiencies of the actual health care through~     the analysis of the speech of the different parts involved (main study). Simultaneously, a~     comparative analysis of the costs of health care will be conducted (economic combined study).~   "
62435|NCT02749656|"~     The purpose of this study is to evaluate efficacy and safety of 0.25% Desoximetasone cream~     (Topoxy®) compare with 0.25% Desoximetasone cream (Topicorte®) in the treatment of scalp~     psoriasis.~   "
62436|NCT02749643|"~     Investigators wish to evaluate the effects of adding VTF to upper limb prostheses on~     functional outcome measures of upper limb prosthetic users.~   "
62437|NCT02749630|"~     This is a randomized, observer-blinded, placebo-controlled study to evaluate safety,~     tolerability, immunogenicity, and pharmacokinetics of repeat dosing of intravenous (IV)~     UTTR1147A. The study will consist of a repeat dose escalation in HVs, in participants with~     UC, and in participants with CD across multiple sites.~   "
62438|NCT02749617|"~     This pilot study will investigate the impact of dexamethasone (DEX) on anti-Xa levels in~     participants taking apixaban 2.5 mg twice a day by mouth (PO BID). Investigators propose a~     prospective, cohort study of 24 participants with multiple myeloma, in whom a~     lenalidomide-dexamethasone (LEN-DEX)-based myeloma treatment regimen is indicated. Eligible~     participants will initiate thromboprophylaxis with apixaban prior to starting their~     DEX-containing regimen and continue until the end of cycle 3. Anti-Xa levels, D-Dimer and~     plasma drug concentration will be measured.~      This pilot study looks to investigate this potential interaction between apixaban and~     dexamethasone to see if it warrants further investigation in a larger study.~      The sample size of 24 provides 90% power to detect a primary outcome of ≥ 50% reduction in~     peak anti-Xa levels from baseline. Secondary outcomes include changes in plasma apixaban~     levels, D-dimer, and symptomatic venous thromboembolism (VTE) and bleeding during a 3-month~     treatment period.~   "
62439|NCT02749604|"~     GreenLight laser PVP currently gains wide acceptance as a minimally invasive treatment for~     benign prostate enlargment and the emergence of ejaculatory sparing techniques made it~     feasible to get both benefits: relief of lower urinary tract symptoms and preservation of~     ejaculation. However evaluation of actual infravesical de-obstruction following such~     techniques remains a grey zone in the literature without an objective assessment of the~     degree of de-obstruction. Furthermore, the impact of maintaining ejaculation on different~     domains of the sexual function using comprehensive assessment tools was not compared in~     ejaculatory sparring vs. non-ejaculatory sparring approaches.~   "
62440|NCT02749591|"~     The aim of this study will be to determine and compare the immediate and longer-term effects~     of combination of BoNT-A injection and mirror therapy vs combination of BoNT-A injection and~     robot-assisted therapy.~   "
62441|NCT02749578|"~     The purpose of this study is to determine whether MGL-3196 alters the pharmacokinetics of~     atorvastatin in healthy male subjects and female subjects not of child-bearing potential.~   "
62442|NCT02749565|"~     The investigators will compare the circulating fibrocyte proportion in asthmatic patients~     with obstructive sleep apnea (OSA) and not with OSA In addition, the investigators will~     compare the expression of epidermal growth factor receptor (EGFR), endothelin A receptor~     (ETAR) and connective tissue growth factor (CTGF) The association of those factors and annual~     decline of forced expiratory volume in 1 second (FEV1) will be performed~   "
62443|NCT02749552|"~     Obesity is a prevalent, destructive, and costly chronic disease. In 2008, 37% of Canadian~     adults were measured as overweight, and 25% as obese. Obesity is a risk factor for a number~     of serious health problems, including type 2 diabetes, asthma, gallbladder disease,~     osteoarthritis, chronic back pain, several types of cancers (i.e., colorectal, kidney,~     breast, endometrial, ovarian and pancreatic cancers) and cardiovascular disease (i.e.,~     hypertension, stroke, congestive heart failure and coronary artery disease). In 2008, it was~     estimated that the annual economic burden of obesity in Canada was $4.6 billion. Given the~     economic strain and widespread health risks of obesity, there is a clear need to provide~     effective interventions for obesity.~      The purpose of the proposed study is to examine the role of ACT-based interventions in~     long-term weight maintenance. The proposed study will examine the role of value consistent~     behaviour, acceptance skills, and mindfulness skills in promoting long-term weight-related~     health behaviours. Acceptance and Commitment Therapy (ACT) is an empirically supported~     psychological intervention that emphasizes value consistent behaviours, acceptance skills and~     mindfulness skills.~   "
62444|NCT02749539|"~     Applications of new treatment modality which is Kinesio tape in post mastectomy shoulder~     problems.~   "
62445|NCT02749526|"~     Endostar ® (recombinant human endostatin) continuous intravenous infusion combined with mPFC~     neoadjuvant treatment of esophageal cancer arm, Ⅱ single-center clinical trial.~   "
62446|NCT02749513|"~     The purpose of this study is to demonstrate that orally administered itraconazole, a commonly~     used antifungal medication, can inhibit Hedgehog pathway signaling in patients with~     esophageal cancer, including adenocarcinoma (EAC) and squamous cell carcinoma (ESCC).~   "
62447|NCT02749500|"~     The purpose of this study is to test the hypothesis that early independent adaptive~     bimanual-to-unimanual training of arm and hand movements, assisted with specially designed~     mechanical devices: the mirrored motion bimanual arm trainer (m2 BAT), will improve motor~     control and function in patients with post-stroke hemiparesis.~   "
62451|NCT02749448|"~     Background: Sulfur mustard (SM) is a potent alkylating agent that targets several organs,~     especially lung tissue. SM exposure leads to serious changes in morphological structure of~     airway system, which is associated with chronic obstructive pulmonary deficiency following~     exposure to SM. With extensive progress and achievements in tissue repair through stem cells~     therapy, consideration of lung tissue has been increased due to the high prevalence of~     pulmonary problems. Several factors such as selection of cell types, required conditions for~     growth and proliferation of stem cells, and the process of entering into the body to repair~     damaged lung tissue are considered as the most important problems in this issue. Accumulating~     studies, both in animals and human with mesenchymal stem cells (MSC) support the hypothesis~     of therapeutic effects of these cells in various disorders. In this study investigators aimed~     to evaluate safety and potential efficacy of systemic MSC administration for treatment of~     chronic lung injuries in SM-exposed patients.~      Methods: Patients will receive 100 million MSC cells every two months for three injections~     within 6 months. After each injection, parameters including safety, pulmonary function~     testing (PFT), quality-of-life indicators, 6 minute walk test (6MWT), and expression of~     inflammation and oxidative stress genes will be evaluated.~   "
62452|NCT02749435|"~     A real-world, point-of-care, randomized, parallel group, open, 6-month clinical study to~     evaluate if the provision of a digital disease management tool improves glycaemic control in~     participants with type 2 diabetes mellitus (T2DM), as measured by change from baseline to End~     of Study (Month 6) in glycosylated haemoglobin (HbA1c) levels. Clinical assessments for this~     study will be conducted as part of normal, standard care. The main objective of this study is~     to evaluate the effect of adding this tool to participants' current standard care for T2DM on~     glycaemic control, other variables of importance in T2DM (eg, weight, blood pressure, and~     lipid levels), and participant-reported outcomes (PROs), such as satisfaction with treatment~     and adherence to their antihyperglycaemic treatment~   "
62453|NCT02749422|"~     This is a randomized, single-blinded, controlled phase 1 study to demonstrate feasibility and~     explore the neurophysiologic and clinical effects of repetitive transcranial magnetic~     stimulation (TMS) interventions in epilepsy patients and healthy controls. The inclusion of a~     control group will be used to see whether epilepsy patients, who suffer from a higher degree~     of comorbid memory difficulty presumably from entorhinal-hippocampal dysfunction, can benefit~     from a TMS intervention can benefit as much as a healthy matched population. Investigators~     will also be looking at functional connectivity between the hippocampus and cortical regions~   "
62454|NCT02749409|"~     Patients diagnosed traumatic rib fracture and need admission will be included. Patients will~     be divided two groups.The experimental group will be given parecoxib after visiting emergency~     department. The control group will be given Narcotic agent such as morphine for pain control.~     The outcome such as numerical rating scale (NRS) and hospital length of stay will be~     recorded.~   "
62455|NCT02749396|"~     Multiple Sclerosis (MS) is the most common chronic neurologic disability in young adult~     females in their childbearing ages. Little evidence is available regarding the association~     between exposure to IFN-beta (β) products and adverse pregnancy outcomes. Therefore the four~     marketing holders of IFN-β are conducting a European-wide IFN-β pregnancy registry.~     Additionally, the Committee for Medicinal Products for Human Use (CHMP) has requested a study~     to enable identification of pregnancy outcomes in the MS population unexposed to IFN-β~     products for comparison with the ongoing European IFN-β Pregnancy Registry.~   "
62456|NCT02749383|"~     This study is a Phase II, single center, randomized, double-blind, placebo-controlled study~     in male and female subjects, aged ≥ 19 years with mild to moderate seborrheic dermatitis of~     the face. All subjects will receive BID topical applications of PAC-14028 cream or vehicle~     for up to 4 weeks.~   "
62457|NCT02749370|"~     evaluate the efficacy of etanercept in adult subjects with moderate to severe plaque who have~     failed therapy with apremilast (Otezla)~   "
62458|NCT02749357|"~     INTRODUCTION:~      The ability to move and transfer own body in an effective manner, is frequently affected in~     people with a spinal cord injury with a negative impact in mood and quality of life, in such~     a way, that achieving an effective locomotion, is one of the main objectives in the~     rehabilitation program in a spinal cord injured patient.~      There are different modalities of locomotion training in spinal cord injury, being the~     robotic orthosis among them, and offering until now, positive outcomes. However there´s still~     a lack of evidence of the optimal training characteristics, in order to establish the best~     time, number of sessions, and progression scheme. For these reasons, establishing the effects~     of different locomotion training programs will provide the necessary data in order to develop~     an effective training program for the maximum benefit of the patient.~      OBJECTIVE To determine the effect of different training programs with robotic gait orthosis~     for patients with chronic motor incomplete spinal cord injury (SCI) (American Spinal Injury~     Association Impairment Scale (AIS) C / D) in short and long term.~      METHODS AND DESIGN. The design of the study consists on a randomized, blinded to the~     observer, clinical trial.~      Patients from the National Institute of Rehabilitation (INR) with spinal cord injury, AIS C~     and D, with at least 6 months of evolution, and who are able to walk with or without gait~     auxiliary, will be eligible.~      Informed consent will be obtained from all subjects prior to participation. Patients will be~     randomly assigned to either one of the two different training groups: intervention or control~     group.~      The control group will be submitted to training sessions of 30 minutes, and the intervention~     group will have training sessions of 60 minutes.~      Both groups will receive a training period of six weeks, five days a week.~      Throughout the training period, gait assessments with the GaitRite instrument, will be~     performed, and repeated at 6 and 12 months after completion of the training as part of follow~     up. The data obtained from the GaitRite will be compared within each group, in order to~     determine which type of training is more effective~      Statistical analysis will be performed using SPSS, considering all P < 0.05 as statistically~     significant.~   "
62459|NCT02749344|"~     This is a pilot study of a novel protocol for preparation of the endometrium for~     frozen/thawed embryo transfer whereby estrogen is not administered during the proliferative~     phase and progesterone is administered through vaginal suppositories in accordance with~     endometrial thickness only, disregarding the day of ovulation. Progesterone supplementation~     commences once the endometrium is at least 7 mm, a follicle is demonstrated on TVS, and~     ovulation has not yet taken place. The day of ET is scheduled according to the unit's working~     days and progesterone suppositories are commenced 48 hours before the scheduled embryo~     transfer.~   "
62460|NCT02749331|"~     An open-labelled, uncontrolled, single-center Phase I/IIa clinical study to evaluate the~     safety of repeated infusions of AdVince into the hepatic artery in patients with metastatic~     neuroendocrine tumors (NETs), and if possible determination of maximum tolerated dose.~   "
62461|NCT02749318|"~     This is a pilot study to determine whether knowledge gained by an individual of genetic risk~     for severe periodontitis changes the patient's health behavior as measured by an increased~     frequency of their preventive dental office visits. In addition to the primary objectives of~     the study, the overall design and logistics will be used to inform a possible future study.~   "
62462|NCT02749305|"~     This long-term, nationwide observational data collection repository will obtain~     patient-reported outcomes from metabolic and bariatric surgery patients. The data will be~     used in conjunction with clinical outcomes to determine quality, safety, and comparative~     effectiveness of various metabolic and bariatric procedures.~   "
62463|NCT02749292|"~     The purpose of this study is to determine the best management strategy to maintain remission~     in patients with ANCA vasculitis who have been treated with rituximab induced B cell~     depletion for at least two years. This study will compare intermittent B Cell depletion upon~     B cell return or intermittent B cell depletion upon serologic relapse.~   "
62464|NCT02749279|"~     The most important drugs for evidence based lipid lowering treatment (LLT) in CHD are~     statins. All patients with established CHD should be treated with statins irrespective of low~     density lipoprotein (LDL) cholesterol (LDL-C) levels. The goals of treatment are LDL-C below~     1.8 mmol/L (70 mg/dL) or 50% LDL-C reduction when target level cannot be reached.~     Unfortunately, several patients cannot achieve treatment targets also related to the serious~     problem of adherence to therapy, which includes also LLT.~   "
62465|NCT02749266|"~     The purpose of this pilot study will be to assess the impact of chiropractic Activator~     adjustments on spatial cognitive abilities through initial assessment and testing in a~     healthy population aged 18 to 35.~   "
62466|NCT02749253|"~     This pilot study is designed to investigate the feasibility of sudarshan kriya yoga (SKY)~     program in adults with post traumatic stress disorder (PTSD) resulting from a wide range of~     trauma experience.~      SKY incorporates standardized collection of breathing techniques which are known to~     positively influence the autonomic nervous system and stress response system. Both these~     systems are dysregulated in PTSD.~   "
62467|NCT02749240|"~     At risk youth face various adversities including homelessness, social isolation, substance~     abuse and other mental illnesses. Thus far, the investigators have successfully partnered on~     programs of housing, social and recreational interventions in this population. The~     investigators now wish to assess the feasibility of delivery of an innovative~     bio-psycho-social intervention, Youth Empowerment Seminar (YES!), developed by their partner,~     the not-for-profit Art of Living Foundation. Therefore, the aim of this research is to~     conduct a proof of concept study to determine the feasibility of a novel YES! program as an~     intervention for at risk youth.~   "
62468|NCT02749227|"~     This is a phase II, open-label, 12-month pilot study in 10 patients with silent corticotroph~     pituitary tumors testing the hypotheses that Pasireotide LAR (long-acting release) treatment~     of patients with silent corticotroph pituitary tumors and elevated plasma Proopiomelanocortin~     (POMC) levels will reduce plasma POMC levels and this will be associated with a reduction in~     pituitary tumor size. Pasireotide LAR 40 mg will be administered monthly. Baseline and~     monthly visits on therapy will monitor plasma levels of POMC, other pituitary function,~     safety labs, glucose tolerance, physical examination, and visual fields. Pituitary magnetic~     resonance imaging (MRI) will be done at baseline, 6 months and 12 months of therapy. The~     eligible patient population will consist of adult patients with known silent corticotroph~     pituitary tumors and elevated plasma levels of POMC.~   "
62469|NCT02749214|"~     The purpose of this study is to determine the potential for a Parkinson's Disease (PD)~     -specific breath signature as a non-invasive screening tool for identifying PD patients with~     inflammation, tracking the progression of disease, and responsiveness to various therapeutic~     interventions, in particular anti-inflammatory or immunomodulatory therapies. Neurological~     disorders include any disorder involving the brain or the nervous system, for example memory~     disorders, stroke, movement disorders and many other conditions.~      The study will lay the foundation for future studies in which breath fingerprinting could be~     used as a screening technique. Investigators will also be looking at how the breath~     fingerprint correlates with inflammatory proteins in the blood.~   "
62470|NCT02749201|"~     To assess gastric wall thickness using transmitted light intensity.~   "
62471|NCT02749188|"~     The urinary tract infections are common in children. It is estimated that about 3% of girls~     and 1% of boys suffer from a urinary tract infection before the age of 11 years. A prompt~     diagnosis and treatment are necessary for the prevention of morbidity and long-term sequelae.~      Currently, there are different methods of urine collection, such as suprapubic aspiration,~     the survey, the collection bag and the jet medium collection.~      They have in common to be time-consuming, invasive in some cases, providers of contaminated~     levies for others and impossible in children incontinent for the last.~      A Spanish study developed a new collection technique, for kidney and bladder stimulation,~     noninvasive, in the new-born to 30-day months. The results are promising with a success rate~     of over 85% within a period of about 45s.~      No study has looked at a broader pediatric population, including children from birth to age~     of acquisition of walking.~      We hypothesize that it is possible to obtain urine in less than 3 minutes, noninvasively, in~     infants who have not acquired the works for which a urine sample is required.~   "
62472|NCT02749175|"~     Cricoid force is applied during airway management to prevent pulmonary aspiration of~     regurgitated gastric contents. This force is usually applied by a nurse or anaesthesia~     assistant. Currently this is performed WITHOUT monitoring and the force applied is determined~     by the individual's educated hand that is derived from his/her experience from past~     training and practice. Studies have shown that the actual force applied by nurse and~     anaesthesia assistant is inconsistent and deviates from the optimal force. Under application~     of cricoid force results in ineffective cricoid pressure and the risk of pulmonary~     aspiration. Consequences of pulmonary aspiration include lung injury and infection, hypoxia,~     long Intensive Care Unit stay and even death. Over exertion of cricoid force results in~     distortion of the larynx (leading to difficult bag mask, difficult tracheal tube insertion~     and hypoxia). Preliminary results from previous study (IRB 2014/437/D), an observation~     crossover pilot was carried out comparing the amount of cricoid force applied by 16 nurses on~     manikin with and without direct feedback. Nurses were instructed to apply a range of force of~     30-44 Newtons on a marked site on the neck region of manikin. A flexiforce load sensor was~     used. Unblinded nurses performed significantly better with feedback using the load sensor~     then blinded nurses. With Funding from a National grant, a real-time measurement of cricoid~     force is developed to give feedback and guide the operator to exert and maintain the TARGET~     cricoid pressure during rapid sequence induction (RSI).~      In this study we aim to verify the sensor system with a manikin and compare the forces~     applied by nurses with the sensor system and without.~   "
62473|NCT02749162|"~     The effect of perineural dexamethasone administered as an adjuvant in prolonging the duration~     of analgesia continues to be under debate. The investigators performed a prospective~     randomized study to evaluate the effect of perineural dexamethasone in different~     concentrations in postoperative analgesia in femoral nerve block for anterior cruciate~     ligament reconstruction.~   "
62474|NCT02749149|"~     This study will assess the benefit in using a frailty score to quantify accurate risk~     pre-operatively in patients undergoing major cardiac surgery in order to predict morbidity~     and disability-free survival post-operatively.~   "
62475|NCT02749136|"~     The purpose of this study is to assess the feasibility and efficacy outcomes of neoadjuvant~     modified FOLFIRINOX and postoperative gemcitabine in patients with borderline resectable~     pancreatic cancer.~   "
62476|NCT02749123|"~     A comparison of transdermal patches for efficacy, side effects and quality of life for~     patients with back pain and arthritis. The three arms in the trial were; prescription~     strength lidocaine 5%, over the counter lidocaine 3.6%, menthol 1.25% and placebo.~   "
62477|NCT02749110|"~     This study evaluates the benefit in women aged from 30 to 65 years, who do not participate to~     the French opportunistic cervical cancer screening program, of an organized screening with~     the proposition by the family physician of a pap-test (usual care) versus a self-collected~     vaginal sample (and a HPV-test). 24 family physicians will participate and will be randomized~     in the usual care arm (12) or in the self-sampling arm (12). Our hypothesis is that~     organizing the screening for these women involving their family physician will major~     participation, and that the self-sampling option will amplify this increase.~   "
62478|NCT02749097|"~     This is a randomized, placebo-controlled, single dose escalation study to investigate the~     safety, tolerability, pharmacokinetics and pharmacodynamics of SHR0534. The study will be~     conducted with starting dose of 10 mg followed by dose escalation groups up to 200 mg. Eight~     subjects will be randomized in 3:1 ratio in each cohort to receive the study drug or placebo.~   "
62479|NCT02749084|"~     This is a INTERVENTIONAL TRANSPLANTATION STUDY WITHOUT DRUGS.~      The INTERVENTION is represented by the INFUSION of DONOR T REGULATORY CELL-ENRICHED~     LYMPHOCYTES to PATIENTS suffering from REFRACTORY CHRONIC GVHD after ALLOGENEIC HEMATOPOIETIC~     STEM CELL TRANSPLANTATION.~      The study includes a DOSE ESCALATION PHASE followed by a MTD PHASE as detailed in the~     following chapter.~      The primary objective of the dose escalation study will be SAFETY, leading to the definition~     of the MTD of T reg cells. For the MTD study the primary objective will be the OVERALL~     RESPONSE RATE at three months after the 3rd Treg infusion.~      The study is single center single arm open label and includes a DOSE ESCALATION phase~     followed by an EXTENDED PHASE with the MAXIMUM TOLERATED DOSE (MTD).~      The aim of the study is to assess whether multiple infusions of donor-derived purified T~     regulatory cells (T reg DLI) in patients with steroid-refractory chronic GVHD is safe and~     whether it may induce clinical remission of GVHD.~   "
62480|NCT02749071|"~     The purpose of this investigation is to demonstrate the safety and effectiveness of Lower~     Esophageal Sphincter (LES) Stimulation System in treating gastroesophageal reflux disease~     (GERD). This investigation is a multicenter, randomized, double-blind, sham-controlled study.~     After the implant procedure, subjects will be randomized to either the Treatment Group~     (immediate stimulation) or Control Group (delayed stimulation) for six months followed by an~     additional open-label phase in which all subjects will receive electrical stimulation.~     Subjects continue on stimulation treatment in an extended open-label follow-up phase through~     5 years post-stimulation.~   "
62481|NCT02749058|"~     The purpose of our study is to evaluate the differences in functional activities and~     proprioception after surgery in subjects who underwent hip prosthesis implant with~     capsulotomy or capsulectomy.~   "
62482|NCT02749045|"~     The overall purpose of this research study is to identify the disparity in ischemia~     measurement between fractional flow reserve (FFR) used in the cardiac catheterization~     laboratory and myocardial perfusion stress- single-photon emission computed tomography~     (SPECT). This study aims to determine the correlation between simultaneous FFR and SPECT~     obtained using regadenoson in the catheterization laboratory.~   "
62483|NCT02749032|"~     The present study is a phase I, single-centre, double-blind, randomized, cross-over (3~     treatments, 3 treatment periods and 6 sequences), stratified (background medication:~     metformin vs. diet-only), placebo-controlled study, comparing periods lasting 6-9 days on~     treatment with repeated doses of vildagliptin, sitagliptin, or placebo, with wash-out periods~     between treatment periods lasting 21 days minimum.~      The study was designed to directly compare the effects of vildagliptin and sitagliptin on~     incretin hormone responses, glycaemia, and insulin as well as glucagon secretory responses in~     patients with type 2 diabetes.~   "
62484|NCT02749019|"~     This is an open-label positron emission tomography/computed tomography (PET/CT) study to~     investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-BBN-RGD in breast~     cancer patients. A single dose of 111-148 Mega-Becquerel (MBq) 68Ga-NOTA-BBN-RGD will be~     injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT~     images.~   "
62485|NCT02749006|"~     Bipolar-I Disorder is a common condition that is characterized by periods of mood elevation~     however periods of chronic and recurring depressive episodes are more common and can be~     severely disabling. Effective treatments exist, however a significant portion of bipolar~     depressed patients do not respond to, or have difficulty tolerating many of these~     interventions. Repetitive Transcranial Magnetic Stimulation (rTMS) is a non-invasive~     neuromodulatory technique that is effective in major depression and there is evidence for its~     efficacy in bipolar depression which needs to be assessed in larger randomized controlled~     trials. This study is a randomised, double-blind, sham-controlled trial over four weeks. The~     primary objective is to assess improvement in depressive symptoms in acute bipolar-I~     depressed patients on treatment with intermittent Theta-Burst Stimulation (iTBS) in~     comparison to sham-rTMS.~   "
62486|NCT02748993|"~     This is a phase 1 and 2 study to assess the safety and efficacy of PAC-14028 cream in~     children with atopic dermatitis.~   "
62487|NCT02748980|"~     The purpose of this study is to investigate the prevalence and degree of coronary arterial~     microcirculaiton dysfunction of non- obstructive coronary artery disease in patients with~     type 2 diabetes. Furthermore, the risk factors of coronary arterial microcirulation would be~     screened and identified.~   "
62490|NCT02748941|"~     Cerebrovascular accident (CVA) constitutes a major health public problem. This represents the~     second cardiovascular death cause. CVA is ischemic in 80% of cases. Atheroma of large~     arteries, mainly carotid, is involved in about 20% of cases.~      After several high grade studies (NASCET, ECST, ACAS, ACST), carotid surgery is based on~     stenosis calculation by Doppler ultrasound, CT angiography, MRI angiography or arteriography.~      The composition of the plaque, showing its vulnerability, is associated with embolic risk and~     stroke. The therapeutic strategy based only on the narrowing of the arterial lumen is not~     satisfactory enough to prevent the occurrence of a transient ischemic attack (TIA) or an~     ipsilateral stroke due to carotid stenosis. Thus, new techniques emerge, to evaluate in vivo~     the inflammation of the plaque, its embolic consequences or the mechanical stress it~     undergoes. These techniques are: High Resolution MRI (HR MRI), evaluation of the Gray Scale~     Median (GSM) level, study of the plaque vascularization with Contrast Enhanced ultrasound~     (CEUS), High Intensity Transient Signals (HITS) by transcranial Doppler, micro RNA profile~     (mi RNA). These different modalities must be combined in order to increase the efficiency.~      Based on these encouraging results, the investigator aim at evaluating the ability of~     different methods or their combination to predict the occurrence of ischemic stroke or TIA~     due to emboli from a carotid atherosclerotic plaque. Before considering a cohort study, he~     investigator want to evaluate the performance of each of these new methods in the~     characterization of carotid plaque instability. Performance evaluation will allow us to~     choose secondarily the most relevant association.~      The investigator propose, as a first step, to make a case-control study with these methods,~     the cases are patients who had an ischemic stroke (authenticated by both the clinical exam~     and brain MRI) on the same side as the carotid stenosis and the controls are patients with~     carotid stenosis but without ischemic stroke. This study is a cross-sectional study because~     it simultaneously measures the occurrence of the event (ischemic stroke) and the~     characteristics of the atheromatous plaque.~      Over a 2 year period, 45 symptomatic patients and 105 asymptomatic patients will be included~     with a carotid stenosis with at least a 50% caliber constriction according to NASCET~     criteria. (North American Symptomatic Carotid Endarterectomy Trial).~   "
62491|NCT02748928|"~     Prospective, one arm, baseline-controlled, clinical study for the evaluation of the~     UltraShape Power treatment using the U-Sculpt Power Transducer for non-invasive abdominal fat~     and circumference reduction.~   "
62492|NCT02748915|"~     The primary objective of this research is to evaluate the relationships between multiple data~     from cochlear implant (CI) adult users to and to estimate predictive models of their fitting~     parameters. In a group of patients, the Electrically-evoked Compound Action Potentials (ECAP)~     will be collected intra-operatively and the correlation with demographic data (deafness~     duration, age deafness onset, etiology, duration of cochlear implant use of CI), auditory~     performances and subjective measures used for implant fitting (hearing threshold and most~     comfortable level) will be calculated. In a second group of experienced users (more than~     9months of use of their CI), ECAP and Electrically-evoked Auditory Brainstem Response (EABR)~     will be collected after 9 months of CI experience and after 12 months or more of use.~     Correlation analyzes with demographic data, performance and fitting parameters will be~     performed as well. Statistical predictive models for both fitting at the activation or in~     experienced users should be developed according to the correlation analysis.~      The secondary objective is to evaluate the effects of simultaneous stimulation on hearing~     performances. Simultaneous stimulations will be delivered in one ear (bimodal condition) in~     patients using an Electro-Acoustic Stimulation device (EAS) or in the two ears (binaural~     condition) for bilateral CI users. ECAP, EABR and speech perception will be measured and~     compared in the different conditions.~   "
62493|NCT02748902|"~     The purpose of this study is to determine if ingenol mebutate 0.05% gel is safe and effective~     in treating common warts on the hands.~   "
62494|NCT02748889|"~     This is an open-label study with two parts, a Phase I study and a randomized Phase II study.~     This study will be conducted at approximately ten sites in the United States. Approximately~     178 patients will be enrolled in this trial.~   "
62495|NCT02748876|"~     Cardiac resynchronisation therapy (CRT) is a specialised type of pacemaker used in patients~     with severe heart failure to improve symptoms and survival. Approximately one third of~     patients treated with CRT do not notice significant improvement in their symptoms and this~     may be due to inadequate co-ordination between the upper and lower chambers of the heart~     (atrioventricular dyssynchrony).~      The investigators propose a new method to achieve atrioventricular synchrony in CRT based on~     measurements of electrical conduction from within the heart. Patients referred for CRT~     implantation at Castle Hill Hospital are eligible to participate. During CRT implantation,~     additional measurements, will be recorded from within the heart. After implantation, device~     settings will be adjusted to either standard or electrophysiologically-optimised settings~     with cross-over at 4 months.~      The investigators hypothesis is that patients with optimised settings will derive additional~     benefit compared to patients with standard pacemaker-determined settings.~   "
62496|NCT02748863|"~     The aim of the study is to demonstrate efficacy, safety and tolerability of 2 mL pre-filled~     syringe of 300 mg secukinumab in treatment of moderate to severe plaque psoriasis.~   "
62497|NCT02748850|"~     Aldehyde dehydrogenases (ALDHs) are cellular enzymes responsible for detoxifying aldehyde~     resulting from the metabolism of endogenous and exogenous xenobiotic cellular constituents.~     Although ALDHs are considered to play an important role in tumorigenesis, the role of ALDH~     activity in cancer stem cells, and more particularly that of the acute leukemia must be~     specified.~      Several studies have shown that ALDHs are potent apoptogenic compounds on normal or cancer~     cells. Therefore, the cells that were damaged and their increased ALDH activity does not die~     by apoptosis but become highly proliferating. This result is a plausible mechanism for the~     evasion of apoptosis, a characteristic shared by many cancer cells.~      On this basis, it is proposed an innovative approach to cancer chemotherapy through~     inhibition of one of the protective mechanisms against apoptosis, ie the increase in ALDH~     activity than cancer cells put involved in overcoming the lethal effects of damaged roads.~     ALDHs of inhibitors they may have immediate application as anti -cancer in vivo? The limited~     experimental data obtained so far on human tumor xenografts in immunodeficient mice and the~     absence of data on the in vivo toxicology do not allow direct passage to clinical trials.~     Indeed, some members of the ALDH superfamily are expressed constitutively in some vital~     organs they protect against the deleterious effects of xenobiotics and adverse endogenous~     metabolites. Consequently, if ALDHs should be inhibited, of the collateral damages for the~     normal cells could occur. However, when normal cells have not undergone deleterious exposure,~     these harmful metabolites are not or in very small quantities, which do not require high~     levels of ALDH activity, and therefore without harm to the inhibition of cell of these~     enzymes.~      From a hematological point of view, it seems essential to test the therapeutic index of the~     inhibitor of ALDH DIMATE between normal hematopoietic cells and leukemic stem. Indeed, in the~     pathophysiology of acute leukemia, the leukemia stem cells are of major importance because~     they are much more resistant to chemotherapy than more differentiated cells and thus causing~     the high rate of relapse observed in acute leukemia despite the high rate of complete~     remission often obtained. In this study, it will be tested in vitro sensitivity of the~     cluster of differentiation 4 and cluster of differentiation 38 (CD4/CD38) highly purified of~     leukemic origin or normal to the DIMATE compound. The objective will be to analyze the~     effects of DIMATE on the parameters of the proliferation, the apoptose, the cytokinins of~     secretions and the changes transcriptomic in general, in order to better define the~     therapeutic index of this compound and to determine all the precursory hematopoietic normals~     and leukaemic cellular effects. The reversible cytostatic of DIMATE effect on normal cells~     but its irreversible apoptotic effect on cancer cells is an advantage to try to eliminate.~   "
62498|NCT02748837|"~     This is the open label, multicenter Phase 1 study which consists of a dose escalation to~     determine the maximum tolerated dose (MTD) and cohort expansion to obtain a preliminary~     evaluation of anti-tumor activity. ERY974 is intravenously injected to patients with Glypican~     3 positive advanced solid tumors until unacceptable toxicity or disease progression.~   "
62500|NCT02748811|"~     GERICO is a randomized, controlled prospective trial. The aim is to investigate if frail,~     elderly patients with stage II-IV colorectal cancer, will profit from full comprehensive~     geriatric assessment and intervention before and during treatment with chemotherapy.~      The hypotheses are: Optimizing the health conditions and functional status of frail elderly~     patients who suffers from stage II-IV colorectal cancer, with geriatric intervention will~     lead to a higher grade of completing the planned chemotherapy and at higher dose intensity.~     This will also result in a higher overall survival and improve quality of life.~   "
62501|NCT02748798|"~     The goal of this research is to optimize the MRI system to obtain ideal lung images using~     Hyperpolarized (HP) Noble and Inert Fluorinated Gases as contrast agents. Lung coils tuned to~     the frequencies of these gases will be used. This study will take place at TBRHSC in the~     Cardiorespiratory Department and in the Research MRI facility.~   "
62502|NCT02748785|"~     To investigate whether a short term discontinuation of methotrexate (MTX) will improve the~     vaccination efficacy to seasonal influenza vaccination without deteriorating RA disease~     activity in a randomized clinical trial.~   "
62503|NCT02748772|"~     The purpose of this study is to determine whether Endostar pumping into vein with Thalidomide~     are more effective in the treatment of Advanced Colorectal Cancer (ACRC).~   "
62504|NCT02748759|"~     Anterior Cruciate Ligament (ACL) injuries by trauma are a prevalent pathology. In the USA,~     about 200.000 injuries are estimated per year, half of which implicate a total rupture of the~     ligament. Data indicates that the number of ACL injuries is increasing in young athletes and~     presents a common problem, especially people playing agility sports.~      One of the most widely used methods for the post-surgical mobilization after ACL is the use~     of Continuous Passive Motion (CPM) devices. These machines are meant to drain residual fluid~     from the articulation and maintain the mobility of the joint and muscles in the knee. Even~     though studies show that, an early mobilization after surgery is beneficial to the~     rehabilitation of the knee joint, recent studies are questioning the efficiency of the CPM~     when compared with the goal of application. While literature suggests that efficacy of CPM~     are related with the magnitude of knee flexion and the Range of Motion (ROM) achieved some~     studies show that the range of motion measured by the CPM is considerably less than the~     actual ROM.~      As other therapy that provides an effective mobilization of the knee joint, the Specific~     Manual Physical Therapy method (Kaltenborn method) takes in account the physiological~     combination of rotation and gliding of the two joint surfaces. This technique mobilizes the~     femorotibial joint by controlling the tibial plateau anteroposterior during flexion and~     posteroanterior during extension of the knee. Therefore, in the past 30 years there are not~     studies comparing ROM measurements obtained with CPM and manual physical therapy methods.~      It is hypothesized that the benefits of the early passive mobilization after ACL~     reconstructive surgery are diminished by the limited efficacy of currently used CPM devices.~     The aim of our study was to determine the range of motion achieved with the passive~     mobilization using a CPM device compared with a manual method (Kaltenborn method) and to~     assess that ROM measurements provided by the CPM correlates the real ROM.~   "
62505|NCT02748746|"~     Bio-electrical impedance analysis and Tissue Dielectric Constant measurements are objective~     methods in clinical usage to detect lymphedema in early stage. The aim of this study is to~     reveal comparative relation these two methods on detecting lymphedema in an early stage.The~     another aim of this study is to determine impedance ratios and lymphedema index (L-dex) by~     using bio-electrical impedance analysis in patients after breast cancer surgery.~   "
62506|NCT02748733|"~     The purpose of this study is to validate the concept of adapted automated PD a modified~     Peritoneal Equilibration Test (PET), will be performed in children on chronic PD. Instead of~     a single 4 hour standard dwell, two double mini PET using the same type and total volume of~     dialysate and the same total dwell time (150min) will be performed in randomised sequence. An~     double mini test consists of two identical dwells, reflecting routine PD, the other one of a~     short small dwell followed by a long, large dwell as suggested from adapted PD regimes~     successfully applied in adult PD patients.~   "
62507|NCT02748720|"~     Approximately 50% of preterm infants less than 32 weeks require respiratory assistance at the~     time of transition at birth. For that stabilization during resuscitation is successful, it is~     essential for proper ventilation. This transition is performed with non-invasive respiratory~     support and administration of positive pressure ventilation to establish adequate functional~     residual capacity. The problem is that a peak inspiratory fixed during ventilation, and~     adequate tidal volume is assumed, but usually not measured, unable to correct the peak~     pressure to optimize ventilation and reduce lung damage. In addition, frequent adverse events~     may hinder or impair the effectiveness of the ventilation, with the consequent deterioration~     in the prognosis of the newborn.~   "
62508|NCT02748707|"~     This is a phase II randomized clinical trial to study the effect of COX-2 inhibitor Celecoxib~     and EGFR tyrosine kinase inhibitor Erlotinib alone or in combination on molecular markers of~     apoptosis and angiogenesis.~   "
62509|NCT02748694|"~     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK)~     of TAK-041 following oral single and multiple doses in healthy participants.~   "
62510|NCT02748681|"~     Study Objectives:~      Meta-analyses report a high prevalence of moderate to severe sleep apnea of more than 50% in~     stroke patients, with adherence rates for CPAP therapy of only 30%.~      The primary objective of this study is to determine whether CPAP adherence in stroke patients~     with obstructive sleep apnea can be improved by a CPAP training strategy during~     rehabilitation combined with a telemedicine monitoring system after discharge.~      The secondary objective is to compare recording quality as well as subjective and objective~     sleep data of non-attended level III polygraphy, polysomnography and telemetric CPAP data in~     the management of sleep apnea in stroke.~      Further the investigators aim to study changes in nocturnal systolic blood pressure due to~     CPAP therapy with the pulse transit time method.~      Finally, the investigators intend to study the relationship between CPAP compliance, sleep~     and medical and neurorehabilition outcome parameters.~      Design:~      Single-blind, mono-center, randomized controlled trial on standard CPAP treatment as compared~     with CPAP treatment with a telemedicine monitoring system in stroke patients with moderate to~     severe OSA.~      Setting: Neurorehabilitation center in Vienna, Austria~      Patients: Adult subacute (1 to 12 months post stroke) stroke patients 18-70 yrs of age) with~     moderate to severe OSA (apnea hypopnea index (AHI) ≥ 15/hr) determined by non-attended~     polysomnography (AHI) ≥ 15/hr of sleep) or level III polygraphy (AHI) ≥ 30/hr of~     out-of-center sleep testing (OCST), who undergo successful CPAP training and titration (goal~     AHI< 10) at the neurorehabilitation unit.~      Interventions: Patients will be randomized to either standard care with an autotitrating CPAP~     device or an autotitrating CPAP device that transmits physiologic information (i.e.,~     adherence, air leak, residual AHI) daily to a website that will be reviewed by their homecare~     provider. If any problems are identified, the patient will be contacted by his homecare~     provider by telephone. Neurologists performing sleep and neurological scoring will be blinded~     to the randomization.~      Measurements: Recording of the different measuring systems, subjective and objective sleep~     quality, CPAP adherence after 3 months and 1 year in hours used per night, systolic BP~     determined by means of a non-linear algorithm and an individual one-point calibration of the~     pulse transit time obtained with a cuff-based BP measuring system (SOMNOmedics GmbH, Germany)~     and neurorehabilitation outcome parameters as Barthel Index, Timed Up and Go Test.~   "
62511|NCT02748668|"~     The objective of the study is to predict outcomes of patients on extracorporeal membrane~     oxygenation (ECMO) therapy by correlating cytokines and inflammatory cell patterns to~     clinical outcomes using data collected in the ECMO Registry at Spectrum Health.~   "
62512|NCT02748655|"~     The purpose of this study is to determine whether consumption of alkaline ionized water is~     effective for accelerating sports recovery.~   "
62513|NCT02748642|"~     This randomized, observer-blinded, placebo-controlled, single and multiple ascending-dose~     study will be conducted in two parts to evaluate the safety, pharmacokinetics, and~     immunogenicity of BITS7201A. Part A will be an ascending, single-dose, sequential-group study~     where participants will be randomly assigned to active drug or placebo. Part B will be an~     ascending, multiple-dose, sequential-group study where participants will be randomized to~     active drug or placebo. Total length of the study is anticipated to be approximately 12~     months.~   "
62514|NCT02748629|"~     The purpose of this trial is to compare clinical outcomes and to analyze cost-effectiveness~     following self-gripping, sutureless Parietex ProGrip Mesh to traditional Lichtenstein~     Operation with lightweight polypropylene mesh.~   "
62515|NCT02748616|"~     In vitro findings have established that ursodeoxycholic acid is a surrogate for deoxycholic~     acid in preventing the growth of C. difficile, and interrupting recurrence. Investigators~     will administer ursodeoxycholic acid for two months, beginning with Metronidazole and/or~     Vancomycin (8 to 10 days), antibiotics currently used for the treatment of acute C.Difficile~     infection. Ursodeoxycholic acid prevents c.difficile recurrence by (a) directly suppressing~     the growth of C. Difficile and (b) permitting restoration of normal fecal bile acid~     composition (80% deoxycholic acid) to maintain growth suppression.~   "
62516|NCT02748603|"~     An observational, retrospective, multicenter, blinded adjudication study to evaluate the~     clinical appropriateness of Percutaneous Coronary Intervention (PCI) indication and execution~     in patients with stable Coronary Artery Disease (CAD) and in patients with acute coronary~     syndrome without ST-segment elevation (NSTE-ACS) (ratio 4:1). Half of the included patients~     will be diabetic. Also the implementation of selected, key guideline recommendations will be~     examined.~      At least 400 patients will be retrospectively selected among 22 Catheterization Laboratories~     in Italy in the region of Lombardia and Veneto.~      This study will be conducted in compliance with Good Clinical Practices (GCP) including the~     Declaration of Helsinki and all applicable regulatory requirements.~   "
62517|NCT02748590|"~     Efficacy of ulcerative colitis to induce remission in patients with moderate to severe active~     ulcerative colitis.~   "
62518|NCT02748577|"~     Primary Objective of this study: To assess experimental heat pain responses (pain intensity,~     pain unpleasantness, pain catastrophizing, emotional reactivity) in migraineurs vs. healthy~     controls.~      The current tools of migraine pain measurement are inadequate to distinguish the overall~     burden of suffering, as there is an over reliance on a single numerical pain score to~     represent the entire pain experience. Measuring and targeting the affective component, in~     addition to the sensory component of pain, may capture this discrepancy in disease burden.~     The affective component of migraine pain may be just as important as the sensory component to~     target and measure since it significantly impacts outcomes, disability, and has therapeutic~     treatment implications.~      Quantitative sensory testing (QST) is a robust lab paradigm (not a clinical experience) that~     delivers one painful noxious thermal stimuli and asks for simultaneous pain intensity and~     pain unpleasantness scores. By using this in the research, investigators will be able to~     differentiate the sensory (pain quality—what the pain feels like) from the affective (how~     awful/unpleasant the pain feels) components of experimental pain in normal controls vs.~     migrainuers.~      No previous studies have evaluated differences in experimental pain intensity vs. pain~     unpleasantness in migraineurs vs. controls. As migraine pain uniquely involves many altered~     sensory phenomenon (e.g., photophobia, phonophobia), it cannot be assumed that responses to~     experimental pain in migraine will be the same as other clinical pain syndromes. Further,~     different clinical pain syndromes have distinct responses to pain intensity vs. pain~     unpleasantness.~   "
62519|NCT02748564|"~     This study will evaluate the safety and tolerability of IL-2 when given in combination with~     pembrolizumab to patients with advanced melanoma. Aldesleukin may stimulate white blood cells~     to melanoma cells. Monoclonal antibodies, such as pembrolizumab, may interfere with the~     ability of tumor cells to grow and spread. Giving aldesleukin and pembrolizumab may kill more~     tumor cells.~      There are two parts to this study:~        -  Phase Ib: To determine the safety and side effects of increasing doses of IL-2 in~          combination with pembrolizumab~        -  Phase II: Once the maximum tolerated dose of IL-2 is determined, additional patients~          will be treated to determine if it is effective against the cancer.~   "
62520|NCT02748551|"~     Nowadays, the proportion of patients with locally advanced gastric cancer is estimated up to~     90 percent of all gastric cancer cases in Russian Federation. Surgical procedure with D2~     Lymphadenectomy is the main option for treatment. Conventional open approach is still the~     current standard for advanced gastric cancer. Laparoscopic procedures for gastric cancer as~     minimally invasive surgery has gained popularity for the treatment of early gastric cancer in~     East Asia. Several studies indicated that laparoscopic procedures both total and subtotal~     gastrectomy with D2 lymphadenectomy is a technically feasible and safe procedure by~     experienced surgeons in high-volume specialized hospitals. However, lack of solid evidence on~     the oncologic efficacy.~      Starting clinical trials for evaluate safety of oncology laparoscopic subtotal gastrectomy~     for locally advanced gastric cancer. Aim of this trial is show safety, feasibility and~     oncologic efficacy of Laparoscopic radical surgical procedures both total and subtotal~     gastrectomy for treatment gastric cancer.~   "
62521|NCT02748538|"~     A randomised controlled trial to evaluate the effect of face-down posturing on retinal~     displacement and distortion following retinal detachment repair.~   "
62522|NCT02748525|"~     This study aims to combine the use of IV CCK administration followed by oral milk during a~     HIDA scan to further stimulate the gallbladder contractility and decrease the number of false~     abnormal HIDA scans and unnecessary cholecystectomies in some patients.~   "
62523|NCT02748512|"~     A controlled, multi-center study to evaluate the utilization and safety of the MK II inserter~     and the safety of the Fluocinolone Acetonide Intravitreal (FAI) insert in subjects with~     non-infectious uveitis affecting the posterior segment of the eye.~   "
62524|NCT02748499|"~     This study aimed to test the effects of a 12-month Healthy Beat Accupunch (HBA) exercise~     program on the perceived health status and sleep quality of the community-dwelling older~     adults.~   "
62525|NCT02748486|"~     The purpose of this study is to determine whether modules of Metacognitive Training: Jumping~     to Conclusions and To empathize... are effective in the treatment of patients with~     schizophrenia. Also it was investigated whether these modules have specific impact on~     cognitive biases severity.~   "
62527|NCT02748460|"~     This is a multi-centre, multinational, prospective, non-interventional study in females with~     a diagnosis of moderate to severe uterine fibroids, and for whom a treatment with Esmya in a~     long term manner is planned, and in subjects who were previously exposed to UPA in the long~     term Phase III studies. It is planned to enrol approximately 1,500 patients. Consecutive,~     eligible, patients will be invited to enrol from approximately 100-150 European Union (EU)~     clinical practice sites in approximately 15 countries. Patients will be followed for an~     observation period of 60 months (5 years) from treatment start. Investigators are to manage~     and treat patients according to their standard medical practice.~      The specific objectives of the study are to assess the long term safety, including~     endometrial safety, of Esmya in standard medical practice and the prescription patterns of~     Esmya in standard medical practice.~      The exploratory objective is to assess patients' quality of life in a long-term treatment~     setting.~   "
62528|NCT02748447|"~     Background: fluctuation of cerebral blood flow and oxygenation in neonates who undergo~     intensive care is an important risk factor for risk of neurodevelopmental impairment. Near~     infrared spectroscopy (NIRS) allow direct measurements of cerebral tissue oxygenation.~     Automated Fraction of Inspired Oxygen (FiO2) adjustment can maintain arterial oxygen~     saturation (SpO2) within a target range and may reduce risk of fluctuation of cerebral~     oxygenation.~      Aim of this study: to evaluate the efficacy of automated FiO2 adjustment in maintaining SpO2~     within a target range and in reducing the risk of cerebral tissue hypo-oxygenation due to~     SpO2 fluctuations in preterm infants on invasive or non invasive respiratory support with~     supplemental oxygen.~   "
62529|NCT02748434|"~     Evaluation of insulin absorption at sites affected by clinically apparent lipohypertrophy~     through short-term continuous glucose monitoring has shown inconsistent results and it is yet~     unknown how or if subclinical lipohypertrophy affects absorption. In this study investigators~     propose to enroll at least 20 people who participated in phase 1 and who were determined to~     have subclinical lipohypertrophy to examine the correlation between glycemic control and~     amount of insulin injected in subclinical hypertrophic areas using capillary blood glucose~     and continuous glucose monitoring.~   "
62530|NCT02748421|"~     In our study , the investigators will use the microscope with OCT ( Lumera with RESCAN OCT )~     coupled to assess the extent , depth and change of retinal architecture in the perioperative~     period . Thus , they will evaluate what the optimal maneuvers of dissection of macular~     membranes to obtain a more satisfactory result of the rearrangement in the retinal layers .~     Furthermore , the use of OCT perioperative may dispense with the use of dyes , decreasing the~     concentration used or reduce the exposure time. Thus, they can get the potential decrease in~     retinal toxicity may be generated by them.~   "
62531|NCT02748408|"~     This is a Post-Marketing Surveillance of SMS femoral stem prosthesis.~   "
62532|NCT02748395|"~     The purpose of this study is to determine whether the injection of triamcinolone and~     lidocaine is effective in relieving chronic abdominal wall pain.~   "
62533|NCT02748382|"~     Despite evidence of the physiologic benefits and possible lower mortality associated with low~     chloride solutions, normal saline remains the most wildly used fluid in the world. Given~     uncertainty about the impact of lower chloride versus higher chloride solutions on mortality,~     it is unlikely that clinical practice will change without new and direct RCT evidence.~     Editorials published in leading critical care journals have called for RCT's to address this~     important clinical question. The proposed feasibility RCT will investigate the feasibility of~     a large-scale trial directly comparing low chloride versus normal chloride for resuscitation~     in septic shock on patient-important outcomes such as mortality and AKI.~   "
62534|NCT02748369|"~     This is a pilot study to establish an arterial venous methodology to measure the activity of~     the TCA cycle or flux directly in tissues of human beings. It will also perform correlative~     studies to study the proteome, metabolome, oxygen consumption, carbon dioxide production and~     exosomes derived from the arterial venous supply of tissues with correlation to the TCA cycle~     activity.~   "
62535|NCT02748356|"~     As a collaborative effort between MedStar National Rehabilitation Hospital (NRH), Children's~     National Medical Center (CNMC) Department of Urology, Children's Research Institute (CRI)~     Center for Genetic Medicine Research, Georgetown University, and MedStar Georgetown~     University Hospital, the overall objective of this study is to develop, validate, and assess~     a patient-initiated, probiotic-based, selfmanagement protocol that is initiated at the time~     of urinary symptoms. The self-management protocol will allow patients to manage urinary~     symptoms and avoid potentially unnecessary antibiotic use, and provide a readily-available~     means of maintaining health, function, and independence throughout the lifespan.~   "
62536|NCT02748343|"~     The purpose of this study is to compare use of a tissue-engineered bone to use of a standard~     allograft bone to treat bone defect in patients. The hypothesis is that use of the~     tissue-engineered bone is effective and safe to treat the bone defect in patients.~   "
62537|NCT02748330|"~     This will be a single-center, randomized, open-label, active-controlled, parallel-group study~     to investigate the platelet inhibition of Ticagrelor versus Clopidogrel with acetylsalicylic~     acid (ASA) as background therapy in approximate 40 patients with stable coronary artery~     disease (SCAD) and type 2 diabetes mellitus (DM) after recent successful elective~     percutaneous coronary intervention (PCI) by evaluation of the P2Y12 reaction unit (PRU) by~     VerifyNow P2Y12 assay at 2-4 hours after the first study drug dose on treatment day 15±2.~   "
62538|NCT02748317|"~     As a collaborative effort between MedStar National Rehabilitation Hospital (NRH)/MedStar~     Health Research Institute (MHRI), Children's National Medical Center (CNMC) Department of~     Urology, Children's Research Institute (CRI) Center for Genetic Medicine Research, and~     Georgetown University Medical Center, the overall objective of this study is to develop,~     validate, and assess a patient-initiated, probiotics-based, self management protocol that is~     initiated at the time of urinary symptoms. The self-management protocol will allow patients~     to manage urinary symptoms and avoid potentially unnecessary antibiotic use, and provide a~     readily-available means of maintaining health, function, and independence throughout the~     lifespan.~   "
62539|NCT02748304|"~     The purpose of the study is to observe the effect of sorafenib combined with aspirin in~     preventing the recurrence in high-risk patients with hepatocellular carcinoma.~   "
74910|NCT02586402|"~     The purpose of this study is to evaluate the safety and efficacy of multiple intravenous~     doses of pegol-Sihematide in participants with chronic kidney disease (CKD) who are on~     dialysis.~   "
62540|NCT02748291|"~     There are over 8.75 million people in the United Kingdom with osteoarthritis in their knees.~     The effect of this condition can be debilitating. Symptoms are due to wear and tear of the~     knee joint. Some people can suffer with knee pain and stiffness. This study will look at~     whether walking improves the symptoms of knee osteoarthritis.~      Investigators will recruit anyone with knee pain over the age of 45 years in Nottingham.~     Participants will undergo a full assessment by a qualified Doctor. After assessment,~     Participants meeting the eligibility criteria will be invited to join the study. Participants~     will be randomly allocated into 2 groups. One group will receive standard health and exercise~     advice. The other group will be allocated a walking activity. This group will undertake 6,000~     walking steps each day. Participants will provide pedometers to monitor this walking~     activity.~      The effect of walking will be compared using questionnaires. These will look at pain levels,~     quality of life and physical activity. The participants will complete these questionnaires~     before the study, at the 6 week midpoint and at the end of the 12 week intervention.~   "
62541|NCT02748278|"~     IVF is a well-established method to treat various causes of infertility. Some studies have~     suggested that ethnicity affects the success of IVF. This is a prospective study involving~     two tertiary IVF units in Hong Kong and Australia. The IVF outcome between Chinese and~     Caucasians will be compared.~   "
62542|NCT02748265|"~     This is a pilot study of a new use of Epoprostenol via inhalation (Epoprostenol is approved~     for intravenous use). The purpose of this study is to administered inhaled Epoprostenol and~     intravenous Phenylephrine to improve arterial oxygen tension during one-lung anesthesia~     either with volatile anesthesia (Sevoflurane) or with intravenous anesthesia (Propofol).~   "
62543|NCT02748252|"~     With aging of the persons living with HIV, cardiovascular diseases now account for~     substantial mortality and morbidity. Stroke frequency grows exponentially with aging and its~     incidence doubles every decade over 55 years of age.~      The prognosis of ischemic stroke depends mainly on the care in Stroke Units in the acute~     phase of the disease (thrombolysis/thrombectomy). It is important that HIV patients are~     referred to these units in the first hours of a stroke and not to their infectious disease~     units which is a loss of chance.~      It would also be important to know whether HIV patients need specific protocols for stroke~     emergency management.~      The study aims to compare the functional prognosis after the first occurrence of an ischemic~     stroke, in patients admitted to a Stroke Unit, whether they are infected or not infected by~     HIV.~   "
62544|NCT02748239|"~     A new diabetes education program for the initiation of non-intensive insulin therapy in type~     2 diabetic patients (MEDIAS 2 CT) was developed.~      In the evaluation, this new developed program is compared with an education programs which is~     currently used for diabetes education. It is expected that the new developed program (MEDIAS~     2 CT) can demonstrate non-inferiority with regard to the main outcome variable glycemic~     control. If non-inferiority can be demonstrated superiority of this program will be tested.~   "
62545|NCT02748226|"~     1. Study design: multicenter retrospective and prospective observational study~        2. Study Cohort :~             1. Retrospective cohort: This cohort retrospectively enrolls patients with lower~               extremity artery disease who underwent endovascular treatment from January 2006 to~               the date of approval by IRB in the participating hospitals. Informed consent was~               waived by IRB.~             2. Prospective cohort: This cohort prospectively enrolls patients with lower extremity~               artery disease who undergo endovascular treatment from the date of approval by IRB~               to July, 2018 in the participating hospitals. Informed consent will be obtained~               prior to enrollment.~        3. Baseline clinical and lesion characteristics, procedural and post-procedural data,~          clinical outcomes, hemodynamic, and imaging follow-up data are investigated. Primary~          patency and target lesion revascularization rates of the total cohort and patient~          subgroups are evaluated. Risk factors of restenosis and target lesion revascularization~          are determined.~   "
62546|NCT02748213|"~     This study will assess the efficacy and safety of intravenous (IV) trastuzumab (Herceptin)~     and IV docetaxel (Taxotere), with or without oral capecitabine (Xeloda), in women with~     previously untreated HER2-positive advanced and/or metastatic breast cancer.~   "
62547|NCT02748200|"~     In this phase 1 trial, the investigators will prospectively evaluate 3 different external~     beam radiotherapy (EBRT) schedules. In every schedule, the whole bladder will be treated to~     40 Gray (Gy) in 20 fractions, 5 fractions/week, 4 weeks in total. Based on the summation of~     abnormalities seen on pre- (initial tumor region) and post transurethral resection zone of~     fibrosis Diffusion weighted-magnetic resonance imaging (MRI) images the tumor region is~     delineated and defined as a gross tumor volume (GTV). The GTV will be treated using a~     simultaneous integrated boost (SIB): without extending the 4-weeks treatment period, 3~     different dose levels will be implemented in order to increase the biological equivalent dose~     (BED), as muscle invasive bladder cancer has been shown to be dose-sensitive.~   "
62548|NCT02748187|"~     Cognitive behavioural analysis system of psychotherapy (CBASP) is one of the only~     psychological models and treatments that has been designed specifically for patients~     diagnosed with chronic depression. CBASP in combination with antidepressants has been found~     to be the most effective treatment for chronic depression. Despite an increasing amount of~     research into this intervention, researchers are less aware of the role that specific and~     common ingredients are accounted for in outcomes. Given that CBASP is a treatment model~     endorsed by the National Health Service Scotland (NHS Scotland), gaining a deeper knowledge~     and understanding about the active ingredients involved in their success ensures current~     practice is embedded in an evidence base. Conducting this research adds to the gap in the~     literature and identifies areas in which further exploration is warranted. Given the emphasis~     on therapist variables in relation to treatment outcomes, the results of this research will~     have wider implications from a service resource perspective. Training may be altered or needs~     emphasised in line with the results of the study to ensure most efficacious outcomes.~      Limited research has looked at therapist and client variables that may contribute to~     therapeutic alliance/engagement, and clinical outcomes. The current study proposes to explore~     two variables that are hypothesized to contribute to outcomes based on the theoretical~     framework CBASP is grounded on, namely therapist and client attachment style and reflective~     functioning. This will be done by providing CBASP to a small number of participants and~     gathering outcome data from therapists and clients at each therapy appointment. Participants~     will also complete the Adult Attachment Interview (AAI), a semi structured interview which~     can also be coded for reflective functioning. This is a proof of concept case series design~     that aims to provide an analysis of individual psychological change in relation to the above~     variables of interest.~   "
62562|NCT02748005|"~     The study evaluates the effect of Fenugreek seed extract (Furosap) in management of~     symptomatic hypogonadism as fenugreek seed extract is a testosterone booster. Fenugreek seeds~     extract are known to possess protodioscin and the extract is reported to improve sperm count,~     sperm morphology and protective effect on male reproductive system. All the participants will~     receive one capsule (500 mg) of furosap once a day.~   "
62549|NCT02748174|"~     This is a naturalistic study of 100 migraineurs and 75 post concussive headache patients who~     will be asked to record their headaches, medications, sleep and other behaviors in a~     smartphone app called Curelator. The software was developed to identify possible headache~     triggers. We seek to determine whether there might be protective headache factors. Patients~     will be given audio files with relaxation therapies. We seek to understand whether this self~     relaxation therapy and/or traditional evidence based behavioral treatment recommended during~     a patient visit is protective against migraine attacks.~   "
62550|NCT02748161|"~     Patients enrolled in this study have been diagnosed with hepatocellular carcinoma (HCC) and~     are scheduled to have a procedure called drug-eluting bead trans-arterial chemoembolization~     (DEB-TACE). During the DEB-TACE procedure, very small beads are mixed in with a chemotherapy~     drug, doxorubicin, and delivered to the tumor through an arterial catheter.~      The DEB-TACE procedure allows the treatment to be delivered directly into the liver. It also~     causes arterial embolization, the process in which a blood vessel is blocked. Treatment of~     HCC using DEB-TACE may help delay tumor progression and can downstage (decrease the size) the~     cancer in order to meet the criteria which may allow patients to become candidates for liver~     transplantation. The purpose of this study is to compare tumor response and medical outcomes~     for patients who undergo DEB-TACE with standard endhole catheter versus Surefire® Infusion~     System.~   "
62551|NCT02748148|"~     The purpose of this study is to identify challenges and successes associated with~     implementing an enhanced medication therapy management service in primary care practice.~   "
62552|NCT02748135|"~     The purpose of this study is to assess the safety and tolerability profile of TB-403~     (humanized monoclonal antibody against placental growth factor (PlGF)) in pediatric subjects~     with relapsed or refractory Medulloblastoma.~   "
62553|NCT02748122|"~     This feasibility pilot is intended to understand whether adolescents with Type 2 Diabetes~     (2DM) can be transitioned to a continuous subcutaneous insulin injection (CSII) and if so,~     assess whether CSII is a feasible treatment modality and improves quality of life (QOL) in~     adolescents with T2DM over 3 month period.~   "
62554|NCT02748109|"~     Our central hypothesis is that chronic balance deficits after mild traumatic brain injury~     (mTBI) result from impairments in central sensorimotor integration (CSMI) that may be helped~     by rehabilitation. There are two objectives of this proposal; the first objective is to~     characterize balance deficits in people with mTBI. The second objective is to use a novel~     auditory bio-feedback (ABF) device to improve measures central sensorimotor integration and~     balance control.~   "
62555|NCT02748096|"~     Patient-specific instrumentation guides have previously been used to improving surgical~     accuracy and ease of implantation during Total Knee Replacement but have received less~     attention for implanting Unicompartmental Knee Replacement. The aim of this prospective study~     is to compare the accuracy of implantation and functional outcome of mobile bearing medial~     Unicompartmental Knee Replacement implanted with and without patient specific instrumentation~     by experienced knee surgeons.~   "
62556|NCT02748083|"~     This trial attempts to evaluate the effects of intensive transcranial direct-current~     stimulation (tDCS) on improving cognition in schizophrenia patients and changes in resting~     state brain network connectivity, especially increasing connectivity in the tasks related~     network, and increasing activation the DLPFC in a working memory task. Half of the~     participants will be randomized to tDCS group, while the other half will be randomized to~     receive sham tDCS.~   "
62557|NCT02748070|"~     While oral steroids have been shown to be effective in the management of patients with~     chronic rhinosinusitis with polyps, its role in treating chronic rhinosinusitis without~     polyps (CRSsNP) is ambiguous. Despite a lack of strong clinical evidence to suggest a benefit~     in this disease state, steroids are often prescribed as a component of post-operative care~     after sinus surgery for patients without polyps. Oral steroids carry with them significant~     adverse effects, and should be prescribed thoughtfully. The aims of this study are to~     determine if oral steroids in the peri-operative period improves patient outcomes in CRS~     without polyps.~   "
62558|NCT02748057|"~     The study will assess the safety and tolerability of MK-0653H (Ezetimibe 10 mg+ Rosuvastatin~     2.5 mg) and MK-0653H (Ezetimibe 10 mg+ Rosuvastatin 5.0 mg) through up to 52 weeks in~     Japanese participants with hypercholesterolemia uncontrolled with monotherapy of Ezetimibe 10~     mg or Rosuvastatin up to 5 mg.~   "
62559|NCT02748044|"~     The prevention and treatment of diseases via artificial intelligence represents an ultimate~     goal in computational medicine. The artificial intelligence for systematic clinical~     application has not yet been successfully validated. Currently, the main prevention strategy~     for rare diseases is to build specialized care centers. However, these centers are scattered,~     and their coverage is insufficient, resulting in inadequate health care among a large~     proportion of rare disease patients. Here, the investigators use deep learning to create~     CC-Cruiser, an intelligence agent involving three functional networks: pick-up networks for~     diagnostics, evaluation networks for risk stratification and strategist networks to~     provide assisted treatment decisions. The investigator also establish a cloud intelligence~     platform for multi-hospital collaboration and conduct clinical trial and website-based study~     to validate its versatility.~   "
62560|NCT02748031|"~     Photography is considered as one of the most important means to promote evidence-based~     medical practice in pediatric ophthalmology.This study is to investigate the feasibility of~     congenital cataract morphological classifications and monitoring using slit-lamp-adapted~     anterior segmental photography in a large cohort that included uncooperative children.~   "
62561|NCT02748018|"~     The purpose of this study is to demonstrate the safety and effectiveness of the Hybrid Closed~     Loop system (HCL) in adult and pediatric patients with type 1 diabetes in the home setting. A~     diverse population of patients with type 1 diabetes will be studied. The study population~     will have a large range for duration of diabetes and glycemic control, as measured by~     glycosylated hemoglobin (A1C). They will be enrolled in the study regardless of their prior~     diabetes regimen, including using Multiple Daily Injections (MDI), Continuous Subcutaneous~     Insulin Infusion (CSII) or Sensor-Augmented Pump therapy (SAP)~   "
62563|NCT02747992|"~     Previous studies have shown that PVB reduces pain and postoperative nausea and vomiting after~     breast cancer surgery when used in addition to general anesthesia or sedation. However, major~     breast cancer surgery involves areas beyond the breast tissue, such as pectoral musculature.~   "
62564|NCT02747979|"~     A prospective, randomized, controlled open clinic trial to evaluate the effect and safety of~     combination of conventional hemodialysis(HD) and hemoperfusion(HP) on middle molecules~     removal and complications improvement in long-term maintenance hemodialysis (MHD) patients.~      There are two phases of study for each subject. Phase 1 (screening phase). During this phase,~     each potential subject will be evaluated to determine if he/she is eligible for the study.~      Phase 2 (intervention phase). Each subject will be randomly allocated to HD+HP(HA130 once per~     week) group ,HD+HP(HA330 once per week) group and HD group. The follow-up duration was 3~     months.~   "
62565|NCT02747966|"~     A prospective longitudinal surveillance for a period of 2 months. Sample - identify suitable~     Chronic Kidney Disease (CKD) patients who undergo HD with functioning AVF. Participants at~     various age range and both sexes are recruited to observe their access flow, access~     recirculation and cardiac function and assess their relationship.~   "
62566|NCT02747953|"~     The program will provide early access to the investigational drug gilotrif in patients with~     advanced non-small cell lung cancer who have failed at least 6 months on erlotinib or~     gefitinib.~      The Compassionate Use Programme will also provide additional safety information on gilotrif~     use.~   "
62567|NCT02747940|"~     Brain signatures as objective measures of acute pain have been characterized with~     functional magnetic resonance image and machine learning technology. As compared to acute~     pain, chronic pain leads to greater socioeconomic burden. However, measures for chronic pain~     remain subjective and suboptimal, and the brain signatures for chronic pain are largely~     unknown. Chronic migraine and fibromyalgia are two prototypes primary chronic pain disorders~     with high disability and intractability with prevalence of around 2% for both diseases. These~     two chronic pain disorders have shared clinical presentations (abnormal pain sensitivity,~     mood and sleep disorders), pathophysiology (central sensitization) and medical treatment~     (anti-depressants), despite different body parts are involved (head vs. whole body). The~     present integrated project aims to characterize both common and disease-specific brain~     signatures of chronic pain by investigating these two chronic pain disorders. Our findings~     may shed some light on the key mechanisms of pain chronification, and may pave the way for~     the optimization of diagnosis and prognostication, as well as formulation of personalized~     medicine in chronic pain, so as to improve life quality of these patients and to reduce~     socioeconomic loss.~      The present project includes three interdisciplinary sub-projects (plus one animal study, not~     listed here):~      A: Clinical studies for chronic migraine and fibromyalgia: endophenotypes and pain~     chronification B: Functional neuroimaging of chronic pain: multimodal quantitative analysis~     of brain connectomes C. Data stream mining technology for multimodal physiological signals of~     chronic pain: real-time tracking and clinical correlation~      The specific aims of the present projects include:~        1. Identification of common and disease-specific brain signatures for chronic pain~          (sub-projects A, B, C)~        2. Investigation of clinical indicators with predictive values by machine learning analysis~          of big data (sub-projects A, B, C)~        3. Elucidation of the specific anatomical structures or neural networks underpinning pain~          chronification based on clinical neuroimaging (sub-projects A, B) In this 1st-year pilot~          study of the 4-year longitudinal study, we will establish experimental platforms for~          each sub-project, start to recruit participants and perform endophenotyping, as well as~          have a preliminary integration for sub-projects A, B and C.~   "
62568|NCT02747927|"~     The purpose of this study is to evaluate the efficacy of 2 doses of Tetravalent Dengue~     Vaccine Candidate (TDV) in preventing symptomatic dengue fever of any severity and due to any~     of the four dengue virus serotypes in 4 to 16 year old participants.~   "
62569|NCT02747914|"~     Leg spasticity is common problem encountered with a large proportion of patients suffering~     with multiple sclerosis (MS) with an increasing severity as the disease progresses. It mostly~     affects the antigravity muscles that significantly complicates transfer, increases fatigue~     and makes walking more difficult. Hence, leg spasticity often interferes with patients'~     mobility and significantly influences their quality of life. A great number of~     multidisciplinary rehabilitation studies has shown a significant effect of numerous specific~     functional changes in patients with secondary (SP) and primary progressive (PP) MS but there~     are no reviews related to spasticity. The positive therapeutic effect of modulating~     Transcranial Magnetic Stimulation ( TMS) methods on spasticity is shown in only two studies,~     in patients with relapse remitting clinical form in the remission phase of the disease. The~     effect of TMS on clinical measures of lower limb spasticity, functional inability and the~     quality of life in patients with SPMS and PPMS will be examined in this study. The objective~     to this study are to to explore whether rTMS boosted exercise therapy (ET) treatment can~     bring more improvement in lower limb spasticity than ET treatment alone in these patients.~   "
62570|NCT02747901|"~     The investigators aim was to compare the effectiveness of kinesiotaping and cold therapy on~     muscle strength and functional performance outcomes in patients with TKA during early~     postoperative period. One-hundred-eleven patents with TKA are going to randomly assigned to~     control, KT and CT groups (nC=nKT=nCT=37).~   "
62571|NCT02747888|"~     Thyroid cancers can occur sporadically, but can also be found as tumors that cluster in~     families with other cancers or genetic syndromes. Researchers are studying thyroid cancer in~     children and families, with a particular interest in understanding genes and other factors~     that may put individuals at risk for developing thyroid cancer and thyroid nodules.~        -  In this study, family and medical history information is collected alongside a blood or~          saliva sample for genetic studies.~        -  Individuals with a past or present childhood thyroid cancer/nodule or a thyroid cancer~          suspected to be inherited in their family are invited to participate.~   "
62572|NCT02747875|"~     The purpose of this study is to determine if methadone improves postoperative pain control in~     pediatric patient's undergoing cardiac surgery.~   "
62573|NCT02747862|"~     The primary objective of this chart review study is to evaluate the outcomes of subjects with~     Attenuated Familial Adenomatous Polyposis (AFAP) and Deleterious Familial Adenomatous~     Polyposis (FAP) who have not undergone surgical resection of the colon.~      A secondary objective of this study is to compare 1) the colonoscopic and pathology histories~     including history of ampullary adenoma in the duodenum over family generations, 2) the use of~     chemopreventive medications, and 3) clinical features of subjects who pursued prophylactic~     surgical resection of the colon with those that have elected to continue routine colonoscopic~     surveillance in an effort to better characterize factors (e.g. polyp burden, ampullary~     adenoma and level of dysplasia, etc) which may influence management decisions.~   "
62574|NCT02747849|"~     The investigators believe in order to strengthen the evidence in support of transcutaneous~     foot stimulation in this population the investigators need to move forward with a randomized~     comparison study using the TENS device on the hand and foot as a control.~   "
62575|NCT02747836|"~     This study evaluates the ability of ultrasound to measure the movement of tendons and nerves~     within the human carpal tunnel.~   "
62584|NCT02747719|"~     Both light and exercise are effective countermeasures for space and ground-based crews for~     circadian phase resetting and alertness levels. The investigators propose to test the~     combined effects of these two countermeasures to determine whether adding exercise to light~     stimuli will further improve circadian phase resetting and alertness.~   "
62576|NCT02747823|"~     This study aims to investigate the bioequivalence of new formulation of bevacizumab called~     CBT124 and safety when compared to two already marketed formulations, one approved in US and~     other in EU of Avastin(Registered Trademark). Adult healthy male aged 18 to 50 years (both~     inclusive) can participate in this trial.~      Participants will be randomised (allocated by chance) to either a test formulation or one of~     the two marketed formulations of bevacizumab. Drugs will be administered intravenously once~     only. The study will compare the safety, tolerability, pharmacokinetics (PK) (the levels of~     drug in the blood), pharmacodynamics (PD) (what the drug does to the body) and immunogenicity~     (body's immune response) of the 3 drugs. In order to measure this, blood samples will be~     collected at various points after treatment has been given.~   "
62577|NCT02747810|"~     Background: Previous animal model studies at the University of Pittsburgh have shown a~     significant impact on inhibiting bladder over activity and increasing bladder capacity with~     neuromodulation techniques, specifically tibial nerve stimulation. This has been translated~     into adult clinical trials through the department of urology. Through the use of a~     commercially available subcutaneous nerve stimulator placed on the dorsum of the foot,~     researchers were able to demonstrate a significant increase in bladder capacity and the delay~     of voiding sensation for up to 5 hours after stimulation in eight healthy subjects. This~     prompted the clinical trial approved under IRB PRO13020474 which is currently enrolling~     patients.~      The incidence of night-time overactive bladder leading to nocturnal enuresis (bed wetting) is~     very common in the pediatric and teenage population, particularly in patients without daytime~     bladder over activity symptoms. When behavioral modification (i.e. refraining from night-time~     fluid consumption and bladder irritants, and bed wetting alarms for timed voiding) fails~     which it often does there is a paucity of effective and safe treatment options. Medications~     can be tried, but generally these are from the tricyclic antidepressant family and carry~     significant side effects limiting the use.~      Aim: Researchers aim to utilize the same technology currently being studied under IRB~     PRO14080250. Electrical stimulation will be applied to the foot via skin surface electrodes~     for a minimum of 1 hour before bed for 2 weeks to 5 normal subjects. Normal Subjects will be~     asked to complete a questionnaire about any skin irritation or experiences of toe twitching~     while wearing the newly designed TENS device, during a return visit with Dr. Stephany. The~     primary outcomes of this study are safety and functionality of the New TENS unit~   "
62578|NCT02747797|"~     Lucitanib is an oral multi kinase inhibitor designed to block the action of certain molecules~     called angiogenic factors that may cause tumors to grow. These factors are called vascular~     endothelial growth factor (VEGF), platelet derived growth factor receptor (PDGFR) and~     fibroblast growth factor (FGF). Lucitanib is experimental and not approved by the FDA for the~     treatment of cancer.~      The purpose of this study is to look at the effects of lucitanib in cancer patients whose~     cancers harbor aberrations in FGFR, VEGFR, PDGFR or other markers predicted to be sensitive~     to lucitanib. This study will also look for biomarkers in samples of blood and tumor tissue~     to identify patients most likely to respond to lucitanib. Biomarkers are substances such as~     genetic material (DNA and RNA) and proteins found in blood and tumor tissue that might show~     if a cancer patient will respond or not respond to a drug.~   "
62579|NCT02747784|"~     The purpose of this open, monocentric randomized, parallel-group, controlled trial is to~     compare two different computer-based cognitive training programs regarding the efficacy to~     prevent the 3-months incidence of postoperative cognitive dysfunction in female patients~     after elective urogynecological or breast cancer surgery.~   "
62580|NCT02747771|"~     This study aims at evaluating the effectiveness of group-based cognitive behavioral therapy~     for trichotillomania at three clinical sites in Norway.~   "
62581|NCT02747758|"~     This study evaluates the effect of additional transcranial direct stimulation (tDCS) on pain~     in patients with chronic neuropathic pain undergoing treatment with regional~     anaesthesiological techniques.~   "
62582|NCT02747745|"~     The growing number of persons with dementia (PWDs) calls for policy changes and service~     innovation. Recent case management (CM) research is recognized by its positive impacts on~     family caregivers (FCGs) of PWDs. However, research gaps are identified, including the~     paucity of theoretical based CM practice and a lack of mediator effects. Therefore, the~     original purpose of this five-year project was to implement a theoretical-based randomized~     controlled CM intervention for FCGs of early to moderate PWDs at home based on a stress model~     and tailor to needs prioritized by FCGs. This project was funded by the Minister of~     Scientific and Technology for the first two years and accomplished the first two aims: 1.~     First year: to develop and test the psychometric properties of related instruments and~     protocol (cross-sectional study); 2. Second year: to conduct a feasibility test for the CM~     intervention (a pilot RCT). The purpose of the current project is to achieve aim 3 (three~     years): to implement a 4-month CM intervention (the main RCT). In total, there will be 2 home~     visits, 2 phone calls to the dyads, and receiving telephone calls from the FCGs during the~     working hours. Investigator will collect 4-time point data at T0 for base line data, T1~     (after the recruitment, 4 th month, the first follow up), T2 (after the recruitment, 6th~     month, the second follow up) and T3 (after the recruitment,12 th month). Investigator will~     recruit 76 dyads in three years (38 dyads for each group)(n = 152 in total). The primary~     outcomes are FCG QoL and PWD behavioral problems, while the secondary outcome is the~     percentages of PWD status (i.g. nursing home admission) and the frequency of PWD acute~     hospitalization. Investigator will also test of mediator effect of FCG self efficacy using~     statistical analysis method such as Hierarchical Linear Modeling (HLM).~   "
62583|NCT02747732|"~     This is a phase 2 study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (ibrutinib), in~     combination with bendamustine and rituximab (BR) in subjects with previously treated~     aggressive B cell non Hodgkin lymphoma (aB-NHL) including any subtype of diffuse large B cell~     lymphoma (DLBCL) primary mediastinal B cell lymphoma (PMBCL), double and triple hit DLBCL,~     transformed indolent lymphoma, unclassifiable aggressive B cell lymphoma between DLBCL and~     Burkitt lymphoma. Patients with CNS involvement (primary or secondary) will be excluded.~     Ibrutinib (IMBRUVICA®; PCI-32765; JNJ-54179060) is a first-in-class, potent,~     orally-administered covalently-binding small molecule inhibitor of Bruton's tyrosine kinase~     currently FDA approved for the treatment of relapsed Mantle cell lymphoma (MCL), Chronic~     Lymphocytic Leukemia (CLL) and waldenstrom Macroglobulinemia (WM).It is under constant~     investigation for the treatment of other B-cell malignancies. The initial approval of~     ibrutinib was received on 13 November 2013 by the United States Food and Drug Administration~     for the treatment of adult patients with MCL who have received at least 1 prior therapy.~     Ibrutinib has not been approved for marketing for the treatment of aggressive B cell lymphoma~     although Phase I trial in this setting has already been published. In Israel ibrutinib is~     registered for the treatment of MCL and CLL.~   "
62585|NCT02747706|"~     There are 7.1 million children with asthma. Asthma is the cause of 10.5 million missed days~     of school, 7.5 million outpatient visits, 640,000 ED visits, and 157,000 hospitalization~     visits in 2008. Recent work has demonstrated that trained peer mentors (individuals from the~     community) can be effective in reducing hospitalizations for asthmatic children.~      This study will evaluate the efficacy of technology-driven parent-to-parent mentoring to~     reduce asthma-related pediatric hospitalizations and emergency department visits.~   "
62586|NCT02747680|"~     This research study is designed to investigate the effect of hypoglycemia (low blood sugar)~     on blood flow to and biochemistry in the brain.~   "
62587|NCT02747667|"~     Late in-the-bag intraocular lens (IOL) dislocation occurs up to 30 years after cataract~     surgery and the prevalence ranges from 0.1% to 3.0%. Before the introduction of the~     continuous curvilinear capsulorhexis, late dislocation was very uncommon but since then~     several case reports and case series were observed. In-the-bag IOL dislocation is a~     well-known postoperative complication, especially in eyes with weak zonules as seen in~     pseudoexfoliation syndrome (PXF), high axial myopia, uveitis and retinitis pigmentosa (RP).~      In this retrospective study, medical records of all patients with IOL related problems after~     implantation of one hydrophilic acrylic single-piece lens at the Department of Ophthalmology~     Graz, Medical University Graz, Styria, Austria are reviewed. Characteristics and predisposing~     factors for late in-the-bag, out-of-the-bag IOL dislocations, and haptic complications will~     be investigated and compared amongst each other or control patients. Incidence rates for each~     IOL complication will be calculated. For in-the-bag dislocations odds ratios for each~     predisposing factor will be calculated.~   "
62588|NCT02747654|"~     Isoniazid (INH) is an essential component of first-line anti-tuberculosis (TB) treatment.~     However, treatment with INH is complicated by polymorphisms in the expression of the enzyme~     system primarily responsible for its elimination, N-acetyltransferase 2 (NAT2), and its~     associated hepatotoxicity. The objective of this study was to develop an individualized INH~     dosing regimen using a pharmacogenetic-driven model and to apply this regimen in a pilot~     study.~   "
62589|NCT02747641|"~     The purpose of this study is to assess the use of the Alma CO2 Pixel FemiLift™ in the~     treatment of VulvoVaginal Atrophy (VVA) in postmenopausal female subjects. The primary~     endpoint is to assess the change in the vaginal dryness by means of a Visual Analogic Scale~     (10 cm VAS) and/or Bachmann Index in VVA. The clinical improvement will be assessed by~     patient filled Vulvovaginal Atrophy.~   "
62590|NCT02747628|"~     Sixty female non-smoker patients, aged 18-50 years and ASA I and II undergoing elective~     laparoscopic cholecystectomy under general anesthesia were included in this randomized~     controlled double-blind study. Patients were randomly divided into 3 groups 20 each, C group~     patients received transdermal placebo patch, TDN group (15 mg/16 h) and TDM group (7 mg/8h).~     Assessment of postoperative pain, sedation, hemodynamic variables such as HR and MAP,~     postoperative monitoring of arterial SpO2 and side effects (e.g. nausea, vomiting, pruritis,~     respiratory depression and hemodynamic instability) were done 30 minutes, 1, 2, 6 and 12~     hours postoperatively. Postoperative Patient`s and Surgeons` satisfaction, Intraoperative~     bleeding and plasma cortisol (µg / dl) 2 hours postoperatively were also assessed.~   "
62591|NCT02747615|"~     Sixty patients aged between 60 and 75 years old of both sex of ASA physical status I and II~     were included in this randomized study who were divided into the study group of 30 patients~     who had been transfused autologous blood and the control group of 30 patients who had been~     transfused only allogeneic blood. Parenteral iron preparation was given to all patients of~     the study group after each donation. Intraoperatively all patients of the study group~     received 2 grams of intravenous tranexamic acid. This study was conducted through the~     laboratory analysis of the hemoglobin and the hematocrit values during blood donation and for~     both groups in the pre-operative and the post-operative period and the assessment of the~     amount of transfused blood units in both groups.~   "
62592|NCT02747602|"~     To compare serum ketone body (i.e., total ketones and β-hydroxybutyrate) levels after~     administration of AC-1204 versus caprylic triglyceride (CT) oil, both after a standard~     breakfast.~      To evaluate the effect of a high fat diet on serum ketone body levels after administration of~     CT oil with a high fat breakfast versus a standard breakfast.~   "
62593|NCT02747589|"~     In this study, the investigators intend to evaluate the use of a commercially available~     neurostimulator system, NeuroPace RNS System to stimulate the visual cortex. The NeuroPace~     RNS System has a proven record of safety and reliability was approved by the FDA in November~     2013. The RNS System is indicated for use in patients with epilepsy and includes a skull~     implanted neurostimulator. No modification to the RNS System is required for this study. This~     study will use this device to better understand the effect of stimulation on the visual parts~     of the brain.~      The main purposes of this study are to confirm the desired location to implant a device in~     the visual cortex, determine the amount of energy needed to elicit vision, and assess the~     nature of the vision that is produced. This information is important to have early in the~     process of designing a visual cortical prosthesis that could eventually be used for~     commercial use.~   "
62594|NCT02747576|"~     Survivors of pediatric medulloblastoma (MB) are at-risk for neurocognitive and social~     deficits, including specific skills such as facial affect recognition which is the ability to~     recognize the emotional expressions of another person. Because the underlying mechanisms of~     these deficits are poorly understood, the investigators propose to examine social-cognitive~     skills (i.e. facial affect recognition) and indices of brain integrity, including an~     established core neural network of face perception in MB survivors and healthy controls. By~     comparing these outcomes between survivors of MB and healthy controls, investigators seek to~     identify the areas of the brain that help individuals recognize emotions.~      Primary Objective:~        -  To evaluate social cognition in adolescent and young adult survivors of pediatric~          medulloblastoma.~      Secondary Objective:~        -  To examine indices of brain integrity and function and their association with facial~          affect recognition in survivors of pediatric medulloblastoma.~   "
62595|NCT02747563|"~     Patients with know prostate cancer (PCa) under active surveillance and aged matched controls~     without evidence of PCa will have a PSA blood test prior to and following standardized~     digital rectal examination~   "
62596|NCT02747550|"~     The aim of this study was to evaluate the efficacy and safety of the temporary simultaneous~     two-arterial occlusions (TESTO) on operative blood loss during laparoscopic myomectomy.~   "
62597|NCT02747537|"~     This study proposes to treat patients with the combination of sorafenib and irinotecan.~     Patients with relapsed, recurrent, refractory, or high risk malignancies whose tumors possess~     a non-synonymous mutation in Raf, PDGFR, VEGFR, Flt-3, KIT, JAK, STAT, RAS, MEK, or ERK will~     be eligible for the study. Very few phase 2 clinical trials have been performed in pediatrics~     using targeted agents in combination with conventional chemotherapy agents. Furthermore,~     since some combinations such as the combination of this study (sorafenib and irinotecan) have~     shown additive/synergistic effects in preclinical studies, therapy selecting for those~     patients who possess mutations targeted by the TKI of the study, may unveil activity that has~     not been previously observed. Thus, the investigators hope to determine whether the addition~     of additive/synergistic chemotherapy will increase efficacy of the targeted agent and/or~     increase tumor susceptibility to the targeted agent, resulting in increased anti-tumor~     activity.~   "
62598|NCT02747524|"~     This study applied a matched cluster, controlled design, using community cluster as the unit~     of randomization. Communities were first matched during the formative research phase and~     randomized into treatment (Vita Mamba + deworming) or control (deworming) groups, using a~     simple experimental 1:1 design. The principal investigator generated the random allocation~     sequence and assigned the cluster to groups. Children were followed longitudinally for Hb~     concentration and anthropometric measures were taken at baseline (November 2014) and endline~     (June 2015). Parents were surveyed at baseline for household-level socioeconomic and~     demographic information; environmental conditions including water, hygiene, and sanitation;~     and child diet and morbidities.~      All children in the intervention schools received the Vita Mamba once per school day from~     November 2014 to June 2015, for approximately 26 weeks. Children in both groups received~     Albendazole at baseline in November 2014. Compliance was monitored by teachers and tracked by~     collection of empty packages. Lessons learned from another school feeding trial by the study~     team were applied to increase compliance such as opening the packages for the children~     immediately prior to consumption to discourage selling or sharing later with family members.~     Vita Mamba was developed for the urban school trial by the research team with representatives~     from Edesia (a US-based nonprofit manufacturer of ready-to-use foods with expertise in~     research and development) and Nutriset (the parent company in the PlumpyField network). Meds~     & Food for Kids, a nonprofit manufacturer of ready-to-use foods in Haiti using locally~     produced peanuts, produced the Vita Mamba for this trial. Vita Mamba (50 g) contains 260 kcal~     and meets >75% of the Recommended Dietary Allowance (RDA) for critical micronutrients (S1~     Table).~   "
62599|NCT02747511|"~     Single center, double-blind, randomized, placebo-controlled trial evaluating analog pain~     scores in patients who present to the emergency department (ED) with a complaint of headache.~     A total of 150 patients age 13-55 presenting to the emergency department with headache will~     be enrolled from October 2015 - October 2016. Patients will be randomized and pain scores and~     side effects will be recorded at 0, 30, 60, and 90 minutes. Follow-up will be performed by~     telephone at 24 hours.~   "
62600|NCT02747498|"~     The purpose of this study is to compare the clinical outcomes depending on catheter ablation~     strategy for repeat ablation procedure among the patients with recurred atrial fibrillation~     after de novo catheter ablation. After randomization, the investigators will conduct~     circumferential pulmonary vein isolation alone in a group, and additional posterior box~     isolation and anterior linear ablation in the other group. Non-pulmonary vein foci ablation~     will be done in all patients. The investigators will compare clinical recurrence rate,~     complication rate, and procedure time, etc.~   "
62601|NCT02747485|"~     New strategies are needed to early detect myocardial involvement in these diseases.~     Histological studies showed that diffuse fibrosis and cardiomyocyte hypertrophy precede the~     LV remodelling (dilatation) observed by cardiac imaging. Quantification of LV diffuse~     myocardial fibrosis using magnetic resonance imaging (MRI) could reach this goal. Recently,~     contrast enhanced cardiac MRI has been used to measure the extracellular volume fraction~     (ECV) of the myocardium, and it has been able to detect diffuse myocardial fibrosis. In~     diseases in which increased collagen deposition enlarges the extra-cellular space, the ECV~     can act as a fibrosis index. ECV is correlated with the amount of fibrosis measured by~     histology. Left ventricular overloads induced by regurgitant VHD result in cardiomyocyte~     hypertrophy and diffuse fibrosis. Other methods can be used to estimate the degree of~     myocardial fibrosis such as the serum level of galectine-3 or ST2. Moreover, although the~     pathophysiological mechanisms leading to the occurrence of myocardial fibrosis differ in~     patients with various cardiac diseases, the cellular effectors of fibrotic remodelling are~     common and involve similar signalling pathways. At the cellular level, key progression of~     ventricular hypertrophy is associated with increased cardiomyocytes apoptosis and fibrosis,~     suggesting that these two processes are responsible for the transition.~      To our knowledge, no study has analysed the impact of the rate of myocardial diffuse~     fibrosis, non-invasively estimated by ECV, in the risk of LV dysfunction during MR and AR,~     especially after surgery. The measurement of ECV could become an important tool for risk~     stratification in left-sided regurgitant VHD. Thus, it would provide an early marker of LV~     myocardial involvement before the occurrence of global remodeling, might help physicians in~     surgical decision, and would improve prognosis. This is an innovative original project~     because it uses modern imaging modalities to answer to a crucial question. The clinical~     implications would be important because this work would modify the international surgical~     indications of MR and AR in order to finally improve the prognosis of patients with this~     frequent heart disease. Moreover, investigators will analyze the genetic factors that can~     influence the myocardial reaction resulting from these regurgitations, which will improve the~     quality of this work and offer new future perspectives.~      Investigators hypothesize that the ECV measurement could be used as an early predictor of LV~     dysfunction in the left-sided valve regurgitations.~   "
62602|NCT02747472|"~     Antagonizing GIP effects during hyperglycaemia in healthy subjects and measurements of~     insulin secretion.~   "
62603|NCT02747459|"~     The purpose of Sensory Supported Swimming is to provide a sustainable, low cost recreational~     swim program for children with ASD. A secondary purpose is to train general recreation~     providers and swim instructors to meet the unique needs of children. Specific aims include~     both program development and research aims as described below.~      Specific Aims:~      1. Provide more opportunities for families of children with ASD to access a recreational swim~     program at low cost. (program development) 2. Increase the capacity of swim instructors and~     general recreation providers working with children with ASD. (Research) 3. Increase physical~     activity for children with ASD in a way that is a good match for their individual sensory~     needs. (Research) 4. Increase safety among children with ASD in and around the water so they~     and their families can swim safely. (Research) 5. Transition swimmers with ASD from a~     learn-to-swim program to an inclusive swim team. (Program Development) Hypotheses~        1. The Sensory Supported Swim Program will increase physical activity of children with ASD.~        2. The Sensory Supported Swim Program will increase safety of children with ASD in and~          around the water.~        3. The Sensory Supported Swim Program will increase the capacity of general recreation~          providers and swim instructors to serve children with ASD.~   "
62604|NCT02747446|"~     The metabolic effects of 7-day weight-maintenance diets containing 10% total energy as acacia~     honey or a fructose:glucose mixture will be assessed in a group of healthy male volunteers.~     Primary outcome is plasma total triglyceride concentrations after ingestion of standardized~     breakfast and lunch containing 25% energy as honey or fructose:glucose mixture; secondary~     outcome is glucose tolerance and suppression of endogenous glucose production after ingestion~     of 75 g glucose. Results obtained with 10% honey and 10% fructose: glucose mixture diets will~     be compared to results obtained with a weight-maintenance, isocaloric diet in which starch is~     substituted for honey or fructose:glucose mixture~   "
62605|NCT02747433|"~     Stroke is the leading cause of long-term disability in older adults in the United States. At~     six months after stroke, up to 65% of the more than 795,000 persons who experience a stroke~     each year continue to have motor impairments that inhibit functional use of the weaker arm~     during daily activities and negatively impact quality of life. Rehabilitation robots provide~     clinicians with new treatment options to improve movement and arm function after stroke. The~     purpose of this pilot study is to develop and test a therapy called the Active Learning~     Program for Stroke (ALPS). We are combining this therapy program with robot-assisted therapy~     and a home program for the stroke-affected arm and hand.~   "
62606|NCT02747420|"~     This is a prospective, single center, double-blind, randomized, controlled trial comparing~     the efficacy of percutaneous tibial nerve stimulation to sham in the treatment of Bladder~     Pain Syndrome/Interstitial Cystitis (BPS/IC) through 12 weeks of therapy.~   "
62607|NCT02747407|"~     This research trial studies qualitative, qualitative, and functional studies over the first~     year in measuring immune system response in patients with brain tumors. Measuring the number~     of immune cells, whether these immune cells work correctly, and response to 2 vaccines at~     several times during the first year of treatment may help find out how active the immune~     system responds to fight infection and cancer.~   "
62608|NCT02747394|"~     Individuals with fragile X syndrome (FXS) demonstrate profound executive function deficits~     that interfere with learning, socialization and emotion regulation. Extensive research~     focused on the animal models of FXS show that targeted pharmacological agents can normalize~     synaptic connectivity and reverse cognitive and behavioral deficits. This translational work~     has led to multiple national and international controlled trials in humans with FXS now~     underway. However, in contrast to the heavy focus on medication treatments, there have been~     no controlled trials to empirically-validate cognitive or behavioral interventions for FXS.~     The proposed study, the first non-pharmacological controlled trial for FXS, will evaluate the~     efficacy of Cogmed, a cognitive training program proven to enhance working memory and~     executive/frontal function in a variety of clinical populations. Demonstration of effective~     Cogmed training for FXS would represent a major advance in the field, one that may also~     generalize to other forms of intellectual disability. Furthermore, it is critical to~     determine whether the targeted pharmacological treatments can accelerate learning and~     cognitive development. Thus, the validation of Cogmed for FXS will provide a paradigm for~     testing hypotheses focused on combined efficacy of medication and cognitive training.~   "
62609|NCT02747381|"~     This study evaluates the effect of vitamin D supplementation in the form of Alfacalcidol on~     the the pulmonary function of adult asthmatic Egyptian patients~   "
62610|NCT02747368|"~     The aim is to study the use of Ocusweep system especially in driving health evaluation and~     compare the results produced by Ocusweep system to those of conventional devices. The main~     focus is in patients suffering from wet age-related macular degeneration. The study aims to~     find out how frequently these patients do not meet the European Union health criteria of safe~     driving and how Ocusweep finds these patients from a population of patients being treated in~     a busy medical retina clinic. The tests of Ocusweep system are compared against conventional~     visual field tests, contrast sensitivity tests, visual acuity tests and tests showing~     anatomical changes related to wet age-related macular degeneration (optical coherence~     tomography, fundus photography and fluorescein or indocyanine green angiography).~   "
62611|NCT02747355|"~     In adrenal tumors, the investigators will examine if there is any correlation between WIESS~     criteria, prognosis of the tumor, and the different labeling index of the following~     proliferation biomarkers: MCM3, MCM2, KI-67, P53, NEUROPILIN -1, METALLOTHIONEIN,~     SEMAPHORIN-3A.~   "
62612|NCT02747342|"~     This is a multicenter, dose-escalation phase 1 trial to evaluate the safety and tolerability~     of SHR3680 given orally to subjects with metastatic castration-resistant prostate cancer~     (mCRPC) as monotherapy.~   "
62613|NCT02747329|"~     The objective of this study is a comparative evaluation of BuMA Supreme™ stent and of Xience~     V/Prime stent in terms of the extent of neointima formation at 1 or 2 months after implanting~     in relatively high bleeding risk patients with coronary artery disease using OCT.~   "
62614|NCT02747316|"~     Overweight and obesity causes low-grade systemic inflammation, which sharply increases risk~     for iron deficiency. Studies in our laboratory have shown that this is mainly the result of~     reduced dietary iron absorption because of increased hepcidin concentrations. During~     pregnancy, women have a large increase in iron needs because of the expansion of maternal~     blood volume and fetal needs. Iron deficiency anemia in infancy can impair cognitive~     development. Whether maternal adiposity impairs absorption and transfer of iron to the fetus,~     and thereby increases risk of iron deficiency in the mother and the infant is unclear.~   "
62615|NCT02747303|"~     This is a randomized study to determine if not treating planning target volume (PTV) margins~     during radiation therapy worsens progression free survival rates in patients with brain~     metastases.~   "
62616|NCT02747290|"~     This is an open-label positron emission tomography/computed tomography (PET/CT) study to~     investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-BBN-RGD in~     prostate cancer patients. A single dose of 111-148 Mega-Becquerel (MBq) 68Ga-NOTA-BBN-RGD~     will be injected intravenously. Visual and semiquantitative method will be used to assess the~     PET/CT images.~   "
62617|NCT02747277|"~     This observational study aims at finding out if individual with autoimmunity exhibit~     increased numbers of B cells that express two types (instead of one type) of antibodies, and~     if B cells of individuals genetically susceptible to autoimmunity display defects in the~     biological process of tolerance, which removes B cells that participate in autoimmunity.~   "
62631|NCT02747095|"~     The CT examination on IQon Spectral CT would be a standard of care CT performed as per the~     clinical indication. The conventional CT images generated by the scanner will be used for~     clinical purposes as routinely practiced. And therefore, the primary study aim is to assess~     the impact of IQon Spectral CT scanner and applications on the clinical workflow of the site~     as well as the diagnostic confidence levels of the physicians reading the CT cases.~      In addition to the aim mentioned above, the investigators would like to develop~     recommendations for the clinical application of the spectral images in routine use. Such~     recommendations could include optimization of scanning protocols, optimization of~     reconstruction parameters; evaluate the utility of iodine maps and other supported materials.~   "
62618|NCT02747264|"~     The purpose of the Electronic Patient Self-Reporting of Adverse-events: Patient Information~     and aDvice (eRAPID) programme is to determine whether eRAPID (an online system for patients~     to self-report symptoms and side effects) can enhance patient care and improve the safe~     delivery of cancer treatments. The investigators hypothesise that patient symptoms will be~     detected earlier with more timely admissions and a reduction in overall hospital contacts. It~     is predicted that staff will save time recording symptoms and side effects and will be able~     to focus attention during clinical contacts on more severe side effects. eRAPID is a~     cost-effective approach to supporting patient self-management and reducing hospital/General~     Practitioner (GP)/community contacts.~      The majority of the research will be run with systemic patients. This particular part of the~     research is a feasibility study in radiotherapy (RT) patients to test the platform in a~     different patient group.~   "
62619|NCT02747251|"~     This study evaluates the addition of a high dose of simple home-based elastic band~     strengthening exercises to usual care in patients with subacromial impingement syndrome. Half~     of the participants receive instructions in simple home-based elastic band strengthening~     exercises in addition to usual care, while the other half receive usual care.~   "
62620|NCT02747238|"~     The investigators believe that ultrasound guided CSE technique will help junior resident~     rotating for the first time on the labor and delivery floor to place more accurately the~     epidural needle in the midline position as compared to placing the epidural needle via~     palpation of anatomical landmarks. This will result in increased ability to place the spinal~     component with positive cerebral spinal fluid (CSF) in the spinal needle, correct midline~     placement of the epidural catheter, and increase the likelihood of adequate symmetrical labor~     analgesia/anesthesia.~   "
62621|NCT02747225|"~     Previously published studies have indicated that there exist difference in electrical~     properties (EPs), i.e., the conductivity and relative permittivity, between malignant and~     adjacent normal tissue, which will be useful in the early detection of cancers. However the~     EP information mainly based on ex vivo measurement of cancer tissues, and few data in vivo~     were published. The purpose of this study is to in vivo measure the electrical properties of~     the malignant tissues.~   "
62622|NCT02747212|"~     Previously published studies have indicated that there exist difference in electrical~     properties (EPs), i.e., the conductivity and relative permittivity, between malignant and~     adjacent normal tissue, which will be useful in the early detection of cancers. While the EP~     informations of cancer tissues are not sufficient enough. The purpose of this study is to~     measure the electrical properties of the excised malignant tissues obtained from cancer~     surgeries.~   "
62623|NCT02747199|"~     This is a prospective, non-randomized, single center clinical trial to assess neointimal~     coverage on the stent or scaffold strut and apposition of SYNERGY™ and ABSORB in minimum of~     12 eligible human subject at 4 month and 12 month after stent or scaffold implantation using~     OCT and CAS~   "
62624|NCT02747186|"~     Anecdotal data suggest that the buffered form of the local anesthetic is more potent at equal~     dosages, and a lower dosage of the buffered drug might be used with an effect equal to higher~     dosage not buffered. Clinical data are needed to confirm these anecdotal data. No published~     data exist comparing buffered local anesthetics at lower drug concentrations to current~     dosages commonly used in dental and oral surgical procedures~   "
62625|NCT02747173|"~     Prospective observational study to assess bone predictive biomarkers for TKI response in RCC~     patients with bone metastasis and HRQoL with TKI in these patients as well as the sensitivity~     and specificity of whole body magnetic resonance versus bone scintigraphy and versus CT in~     the assessment of metastatic lesions at bone level and at other sites.~   "
62626|NCT02747160|"~     The purpose of this study is to examine the feasibility and acceptability of and patient~     adherence to a telephone-administered cognitive-behavioral therapy intervention for anxiety~     in older adults (65 years and older) with cancer and their primary informal caregiver. This~     study will also examine whether the intervention has a clinically significant impact on~     patient anxiety (primary outcome) and depression, distress, and quality of life (secondary~     outcomes).~   "
62627|NCT02747147|"~     Prospective, randomized, single-center study to evaluate the ability of the device to collect~     good quality blood samples from patients with peripheral IV access over the length of their~     stay.~   "
62628|NCT02747134|"~     In the present study researchers aim to investigate the effectiveness of an intervention~     combining emotion regulation and mindfulness skills in a single 10-week program. A total of~     75 individuals with major depressive disorder (MDD) diagnosis in complete or partial~     remission participated in this randomized controlled trial (RCT) comparing an intervention~     including emotion regulation and mindfulness skills (ER+M) with a psychoeducative program.~     After treatment, participants were followed for a 1-year period. Researchers results indicate~     that ER+M was not more effective than the treatment used with the control group in preventing~     depression relapse. Participants allocated to the ER+M group showed a significant decrease on~     global psychiatric symptoms, whereas those in the control group did not. Further studies are~     needed in order to better determine the combined effects of mindfulness and behavioral~     activation.~   "
62629|NCT02747121|"~     External inspections are widely used as means to improve the quality of care. Despite their~     widespread use, there is limited knowledge about whether and how they affect the quality of~     care. This study uses inspection with detection and treatment of sepsis in hospitals as a~     case to evaluate the effect of inspections on the quality of care and to explore how~     inspections affect the hospitals.~   "
62630|NCT02747108|"~     This study will evaluate the effects of screening for type 2 diabetes mellitus (T2DM) and~     brief counseling about screening test results on weight and key health behaviors among~     Veterans with risk factors for T2DM. Study participants will be randomly assigned to one of~     two study groups: (1) Blood Test Group or (2) Brochure Group. Participants in the Blood Test~     Group will complete a blood test called hemoglobin A1c (HbA1c) which measures average blood~     sugar levels. Participants will receive brief counseling about the results from their primary~     care provider or someone authorized to speak on their behalf. Participants randomly selected~     for the Brochure Group will review a handout from the VA National Center for Health Promotion~     and Disease Prevention (NCP) on recommended screening tests and immunizations. All~     participants will be asked to complete a survey prior to study group assignment, immediately~     after a Primary Care appointment, 3 months after enrollment, and 12 months after enrollment.~   "
62633|NCT02747069|"~     This study will evaluate the accuracy of both an electronic stethoscope and electrocardiogram~     (ECG) to evaluate heart rate in neonatal patients in the delivery suite.~      The initial phase of this study will assess the electronic stethoscope use on stable neonates~     on the neonatal care prior to use in the delivery room.~   "
62634|NCT02747056|"~     The research aims at clarifying the impact of autism on personal identity in adulthood. Two~     studies will be made in order to compare adults with autistic spectrum disorders without~     intellectual deficiency and controls. In the first study (Study A), the investigators will~     ask subjects to tell autobiographical memories and to specify their characteristics by~     answering focused questions. In the second study (Study B), the investigators will ask~     subjects to say the self statements which define them. Then, subjects will have to tell and~     to specify the characteristics of the autobiographical memories linked to these self~     statements.~   "
62635|NCT02747043|"~     This trial is designed to determine what effects the human body has on the~      investigational medicine, ABP 798, and what effects the body has on the investigational~     medicine after you have been given it, and if this is comparable to what is seen for the~     licensed medicine, rituximab, in patients with CD 20 positive B-cell non Hodgkin lymphoma.~      This study will assess if the investigational medicine is safe and effective in treating CD~     20 positive B-cell non Hodgkin lymphoma.~   "
62636|NCT02747030|"~     In central retinal vein occlusion (CRVO) a blood clot blocks the venous outflow of the entire~     retinal circulation. This leads to retinal and vitreous hemorrhages, retinal edema and~     neovascularization. The development of a microneedle and surgical stabilizer made it possible~     to perform a prolonged (10 minutes) retinal vein cannulation with infusion of Ocriplasmin.~     Ocriplasmin has the advantage over tissue Plasminogen Activator (tPA) that it already is an~     active enzyme and a strong fibrinolyticum. This study aims to investigate the feasibility and~     safety of local intravenous Ocriplasmin for CRVO.~   "
62637|NCT02747017|"~     The primary objective of this observational study is to estimate the 90-day response rates to~     treatment for a first episode of C. difficile infections (CDI) in adult transplant~     recipients.~   "
62638|NCT02747004|"~     The main purpose of this study is to evaluate the safety and efficacy of abemaciclib plus~     tamoxifen or abemaciclib alone in women with previously treated hormone receptor-positive~     (HR+), human epidermal growth factor receptor 2 negative (HER2-), metastatic breast cancer.~   "
62639|NCT02746991|"~     This is a phase 3, multi-center, randomized, masked, controlled study to evaluate the safety~     and efficacy of an injectable fluocinolone acetonide intravitreal (FAI) insert for the~     management of subjects with chronic non-infectious uveitis affecting the posterior segment of~     the eye. Patients will be randomized to receive either a sham injection or the FAI insert and~     will be observed for three years following treatment.~   "
62640|NCT02746978|"~     Shepherd Center is bringing a more patient-centered focus to educational, peer-support, and~     technology resources offered to patients with spinal cord injury and their families and is~     evaluating these changes.~      Approximately 740 patients have provided information about healthcare utilization following~     inpatient rehabilitation. This information will help Shepherd Center staff follow utilization~     trends and plan programs targeted at the high-use areas.~   "
62641|NCT02746965|"~     This trial attempts to evaluate the treatment efficacy of magnetic seizure therapy (MST) and~     its safety among schizophrenia patients. Half of the participants will be randomized to MST~     group, while the other half will be randomized to receive electroconvulsive therapy (ECT).~   "
62642|NCT02746952|"~     The purpose of this study is to evaluate the safety and tolerability of ascending doses of~     UCART19 in patients with relapsed / refractory (R/R) B-cell acute lymphoblastic leukaemia~     (B-ALL) and to determine the maximum tolerated dose (MTD).~   "
62643|NCT02746939|"~     The study is designed to examine whether curriculum, designed in partnership with teachers at~     Moreland Elementary school in West St. Paul and Mayo Clinic InSciEd Out scientists, is able~     to influence the behavior and health literacy of students. This information will be collected~     in surveys before and after the students are given the curriculum during the school day.~   "
62644|NCT02746926|"~     3 different formulations and doses of tafamidis will be compared. Subjects will be fasted for~     each test and every subject will test all 3 different formulations. After swallowing~     tafamidis, tafamidis blood concentrations will be measured periodically for 8 days. After 14~     days, subjects will take a different formulation of tafamidis and tafamidis blood~     concentrations will be measured periodically for 8 days. After another 14 days, the last~     formulation will be tested in the same way.~   "
62645|NCT02746913|"~     The purpose of this study is to compare two methods for assessing patients with pelvic organ~     prolapse for occult stress urinary incontinence. Urodynamic testing is the most widely~     accepted and well-studied method for diagnosing occult stress urinary incontinence~     preoperatively, but an ambulatory pessary trial is a less expensive option that is available~     to a wider group of practitioners and evaluates patient while they are engaged in their daily~     activities.~   "
62646|NCT02746900|"~     Spontaneous preterm birth (SPTB) remains the number one cause of perinatal mortality in many~     countries, including the United States. In singleton gestations a short cervical length (CL)~     on transvaginal ultrasound (TVU) has been shown to be a good predictor of SPTB.~      Different strategies have been adopted for prevention of SPTB. Growing interest has focused~     on pessary for prevention of SPTB. Cervical pessary is relatively non-invasive, easy to use,~     does not require anesthesia, can be used in an outpatient clinic setting, and it is easily~     removed when necessary. However, a recent systematic review and meta-analysis of randomized~     clinical trials showed that in singleton pregnancies with short cervix, prophylactic use of~     the pessary did not reduce the rate of spontaneous preterm delivery or improve perinatal~     outcome. The evidence supports the use of vaginal progesterone in singleton pregnancies with~     short cervix, while cervical cerclage seems to be beneficial only in the subgroup of women~     with both prior SPTB and TVU CL ≤25mm. Interestingly, only 235 singletons without prior~     SPTB,7 and 504 singletons gestations with prior SPTB,6 have been included in randomized~     studies on cerclage for TVU CL ≤25mm. A meta-analysis of four trials showed that cervical~     cerclage did not prevent SPTB in women with short TVU CL and without prior preterm birth.7~     However, even if the statistical significance were not reached, they found a reduction in~     SPTB <35 weeks by 16% in singletons with short TVU CL and without prior SPTB (20.6% vs 31.2%;~     relative risk (RR) 0.84, 95% confidence interval (CI) 0.60 to 1.17) and by 24% in singletons~     without risk factors for SPTB (25.6% vs 33.3%; RR 0.76, 95% CI 0.52 to 1.15).~      Therefore, the aim of this study is to evaluate the efficacy of cervical cerclage in~     prevention of SPTB in singleton pregnancies with short TVU CL in second trimester, without~     prior SPTB.~   "
62784|NCT02745080|"~     The purpose of this study is to compare the safety and efficacy of secukinumab monotherapy~     and adalimumab monotherapy in patients with active psoriatic arthritis who are naïve to~     biologic therapy and are intolerant or having inadequate response to conventional DMARDs~   "
62647|NCT02746887|"~     This is a follow-up cohort study of 8 years old children born preterm at Seoul National~     University Children's Hospital in Korea from 2008-2009.~      The children will visit outpatient clinics for examinations regarding growth, obesity and~     other risk factors related to metabolic syndrome.~      The purpose of this study is to compare growth and risk factors of metabolic syndrome among~     children born preterm and children born healthy term at school age~   "
62648|NCT02746874|"~     More than 300,000 total knee joint replacement surgeries are performed per year in the United~     States and safe, effective management of post-operative pain in these patients, often~     elderly, deconditioned, obese, or with co-morbid diseases like sleep apnea, can be~     challenging and often require a multidisciplinary, multimodal approach. Opiates have been a~     mainstay of treatment in the post-operative period with varying degrees of success and~     complications. Inadequately controlled postoperative pain is not uncommon. Poorly controlled~     pain inhibits early mobilization and hinders post-operative physical therapy.~      A new paradigm for treating post-operative pain following total knee replacement may be the~     use of cooled radiofrequency ablation (C-RFA) of the articular sensory nerve supply of the~     knee capsule prior to surgery, to desensitize the knee by blocking sensory afferents to the~     anterior capsule and thereby decrease post-operative pain. There are several publications~     that have demonstrated the use of RFA in patients with chronic knee pain from osteoarthritis~     however the use of RFA in the preoperative management of pain in patients undergoing total~     knee joint replacement has not been investigated.~      The aim of this study is to determine if patients undergoing unilateral total knee~     replacement obtain any post-operative pain relieving benefits from C-RFA of the articular~     sensory nerve supply when performed prior to surgery, as compared to sham controls who~     receive only local anesthetic injections of these same nerves without the benefit of ablation~     treatment.~   "
62649|NCT02746861|"~     The objective is to evaluate the efficacy of a web-trained workforce of Hispanic and African~     American diabetes peer mentors delivering Diabetes Self-Management Support (DSMS) to patients~     with poorly-controlled diabetes.~   "
62650|NCT02746848|"~     For severe ocular surface diseases, such as chemical and thermal injuries, Stevens-Johnson~     syndrome (SJS), Band Keratopathy, Corneal Dystrophies, Refractive (PRK-LASEK), corneal~     surgery and others, it is important that short time treatment with minimal side effect should~     be considered. This study is a prospective clinical trial to use Amniotic Membrane Extract~     Eye Drop (AMEED) as a natural substance for acceleration of corneal healing~   "
62651|NCT02746835|"~     Middle-aged or older people with fall risk were assessed and invited to a multidisciplinary~     falls prevention program. This program consisted on an adapted exercise program.~      Two sessions per week were performed, during 6 weeks supervised by a physiotherapist.~      At the end of this program, measures of physical condition and of self-efficacy were repeated~     to determine its related-effect.~   "
62652|NCT02746822|"~     Thirty patients with acute ST-elevation myocardial infarction treated with primary PCI and~     aspiration of thrombus material from the infarct related coronary artery will be included.~     Both cellular and non cellular content of the thrombus will be examined with morphological~     and immunohistochemical methods and related to time from onset of symptoms to PCI, as well as~     to the degree of myocardial necrosis. Furthermore, mRNA expression of selected signal~     molecules will be performed. In addition, peripheral venous blood samples will be drawn and~     analyzed for signalling molecules and corresponding mRNA expression in circulating~     leukocytes.~   "
62653|NCT02746809|"~     The study objectives are to assess the safety and efficacy of the CoreValve Evolut 34R~     transcatheter aortic valve replacement (TAVR) system in patients with severe symptomatic~     aortic stenosis who are considered at high or extreme risk for surgical aortic valve~     replacement.~   "
62654|NCT02746796|"~     The purpose of study is to evaluate the efficacy and safety of ONO-4538 with chemotherapy in~     unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer)~     not previously treated with the first-line therapy. Part 1 is intended to evaluate the~     tolerability, safety, and efficacy of ONO-4538 in combination with SOX therapy (Tegafur /~     gimeracil / oteracil potassium + Oxaliplatin) or CapeOX therapy (Capecitabine + Oxaliplatin).~     In part 2, the investigator or the subinvestigator will choose a chemotherapy (SOX or CapeOX~     therapy), taking into account the condition of each subject. Part 2 is planned to evaluate~     the efficacy and safety of ONO-4538 + chemotherapy in comparison with placebo + chemotherapy.~   "
62655|NCT02746783|"~     This study will assess the effect of a different dose of the seasonal flu vaccine 2013-2015~     on the immune response to improve the investigators understanding of cellular and humoral~     immune responses induced. The scope of this study is to determine the profile of cellular~     activation and antibody production in the ageing immune system following flu immunization.~      This study will enroll 100 male or female subjects ≥65 year old and 90 transplant recipients.~     These persons will be deemed to be  at risk  in case of influenza infection and should be~     vaccinated according to Swiss Federal Office of Public Health. A medical doctor from the CHUV~     will inform the patients about the present study and ask them whether they would be willing~     to participate in the study.~      All subjects will be distributed between the two groups according to a computer-generated~     randomization sequence. The randomization will be done in blocks to ensure balance across~     groups. The participants and site staff will not be blinded due to the different~     administration assignments.~      Group 1 subjects will receive a single dose and group 2 subjects a double dose of MUTAGRIP®~     manufactured by Sanofi Pasteur containing A/California/7/2009 (H1N1); A/Texas/50/2012 (H3N2);~     B/Massachusetts/2/2012. Vaccine immunogenicity and safety will be assessed 1, 2, 4 and 24~     weeks after vaccination.~      Study duration per volunteer is 6 months after vaccination.~   "
62656|NCT02746770|"~     Spanish population with unilateral peripheral vestibular disorders.~   "
62657|NCT02746757|"~     The study was designed to investigate whether glucagon like peptide-1 is a mediator of~     protection of endothelial function induced by remote ischemic conditioning in~     ischemia-reperfusion~   "
62658|NCT02746744|"~     A randomized phase 3 study comparing Rituximab with Dimethyl Fumarate in early~     Relapsing-Remitting Multiple Sclerosis and Clinically Isolated Syndrome.~   "
62659|NCT02746731|"~     The purpose of this study is to determine whether a combined cardiorespiratory and~     strengthening training prior to colorectal surgery decreases the rate of surgery-related~     complications.~   "
62660|NCT02746718|"~     A breach of respiratory function may be one of the elements more or less early or predominant~     clinical picture of neuromuscular diseases. It is considered that the obstructive syndromes~     represent 64% and restrictive or mixed syndromes 36% of chronic respiratory insufficiency,~     approximately 7% due to a neuromuscular disease. The frequency and type of impairment are~     dependent on the underlying pathology.~      The neuromuscular restrictive respiratory failure (IRR) remains partially unknown~     pulmonologists, especially because the signs of muscle weakness are sometimes difficult to~     detect. However, respiratory diseases are a major concern in neuromuscular diseases because~     they can have an impact both on sleep (not sleep, ...) on the daily activities~     (breathlessness on exertion, dyspnea) and thereby alter the quality of life of patients.~     Moreover, they represent a significant morbidity and mortality factor. Chest tightness may in~     some cases reveal the disease and thus constitute the chief complaint of a patient with a~     neuromuscular disease. In late-onset Pompe disease, lung disease is the predominant clinical~     symptoms in about 30% of patients.~      An algorithm was developed to guide practitioners and help them in their diagnostic approach~     to the cause of the IRR (diagnostic algorithm ATS / ERS 2005). However, this algorithm does~     not allow precise identification of the neuromuscular causes.~      At the patient level, this can have an impact by extending the time before placing a~     diagnosis. In Pompe disease, the average time to diagnosis reached 7.9 years. However, there~     are for this disease a simple and rapid diagnostic test. Therefore, a greater awareness of~     practitioners with regard to the particular Pompe disease and neuromuscular diseases in~     general may be beneficial to patients.~      This study aims to:~      i) awareness pulmonologists to the possibility of neuromuscular an IRR.~      ii) characterize the frequency of neuromuscular origin of IRR in a broad population of~     patients with concomitant signs muscle weakness.~      iii) reduce the time to diagnosis by directing patients to neuromuscular reference center~     early.~   "
62661|NCT02746705|"~     This study will test the tolerability and preliminary efficacy of transcranial direct current~     stimulation (tDCS) combined with a cognitive training program, remotely-delivered using a~     telemedicine protocol in 60 adults with multiple sclerosis (MS). The study will evaluate the~     efficacy of tDCS to evaluate two of the most debilitating symptoms of MS: cognitive~     impairment and fatigue.~   "
62662|NCT02746692|"~     Sports medical experts recommend considerable amounts of regular physical activity in order~     to improve strength, motor control, endurance and flexibility. However, only a small share of~     the population is able to meets the corresponding international guidelines. One reason for~     this is supposed to consist in private scheduling problems and the high time expenditure.~     Against this background, high-intensity intermittent training methods with short durations~     have become popular.~      The present study aims to evaluate the effectivity of a high -intensity functional circuit~     training (the FIT15 program) in improving body function.~      Thirty healthy individuals will be included in the randomized, controlled two-armed parallel~     group trial. In the intervention group, the participants will perform the FIT15 program, a~     group-based high-intensity circuit training based on functional movement patterns (e.g.~     squats, push-ups, burpees, jumps, rope-skipping). The training will be carried out three~     times a week, each 15 minutes for a total of six weeks. In the control group, the~     participants will exercise three times a week (in total for six weeks) at moderate intensity~     on an ergometer according to the cardiopulmonary exercise guidelines of the American College~     of Sports Medicine. Outcomes assess prior and following the six-week training period~     encompass body fat and muscle mass (bio impedance analysis), aerobic exercise capacity~     (spirometric exercise testing including lactate analysis), postural control (force plate),~     maximum strength of the leg extensors and shoulder muscles (1 repetition maximum) and~     psychometric variables (e.g. physical activity readiness questionnaire).~   "
62663|NCT02746679|"~     The purpose of this study is to determine whether mindfulness based stress reduction are~     effective on improve anxiety, depression and quality of life in women with intrauterine~     adhesion~   "
62664|NCT02746666|"~     The purpose of this study is to investigate the impact of pharmacist behavioral~     intervention's influence on breast cancer patients' quality of life. Croatian randomized~     controlled trial. Targeted population: general population of breast cancer patients under the~     first adjuvant anthracycline chemotherapy. Primary outcome: difference in EORTC QLQ-BR23~     questionnaire result from the baseline to after 3 week cycle.~   "
62665|NCT02746653|"~     The use of the TroClose1200™ will be done in at least one 12mm planned access port per the~     TroClose1200™ Instruction for Use. The procedure will be performed routinely. Adverse Events~     and device malfunctions, if any, will be recorded. Subjects will be hospitalized in~     accordance with the hospital guidance. All subjects will be followed at 2 weeks (+/- 4 days),~     at 6 weeks (+/- 1 week), at 12 months (+/- 1 month) and at 24 months (+/- 2 months) in which~     healing, signs of hernia and adverse events will be recorded. In the 12 and 24 months visit,~     the hernia signs will be evaluated by ultrasound.~   "
62666|NCT02746640|"~     In case of a cardiac arrest it is very important to quickly provide high quality~     cardiopulmonary resuscitation (CPR). For reasons of patient safety the investigators want to~     assess the frequency, the quality and the outcome of cardiopulmonary resuscitations in the~     Inselspital Bern.~   "
62667|NCT02746627|"~     Problems with diabetes management in adolescents with type 1 diabetes are common - occurring~     at rates as high as 93% - and have serious health consequences, including poor blood sugar~     control and risk for later complications. Therefore, the investigators proposed to test a~     positive psychology intervention for adolescents with type 1 diabetes aimed at increasing~     motivation for diabetes management; specifically, to increase the frequency of blood glucose~     monitoring. This intervention will boost positive mood in adolescents (age 13-17) through~     tailored exercises in gratitude, self-affirmation, small gifts, and parent affirmation as a~     way to improve motivation for diabetes management. In addition, this study will explore the~     use of technology, by comparing telephone-administered vs. automated text-messaging versions~     of the intervention, to determine which mode of delivery is more appealing, convenient, and~     beneficial for adolescents in managing their diabetes.~      Participants and parents will complete questionnaires on mood and diabetes management during~     a routine clinic visits at baseline, 3 months, and 6 months. Clinical measures of diabetes~     management will be collected from participants' electronic medical records.~   "
62668|NCT02746614|"~     People with intellectual and developmental disabilities (IDD) usually present limitations at~     adaptive behavior and motor skills, which lead to limitations/barriers in the daily~     independent functioning of this population. The main goal of this research is to analyze the~     efficacy of a Psychomotor Intervention Program on adults with and without IDD, through an~     assessment of their progress both in adaptive behavior competences and motor proficiency~     skills.~   "
62669|NCT02746601|"~     The purpose of the research is to identify the prevalence of preconception health (PCH) risk~     factors in the Wellington-Dufferin-Guelph (WDG) catchment area and to determine whether or~     not a client-driven electronic preconception health risk assessment tool My Health~     eSnapshot, for use during healthcare visits, will increase preconception health knowledge~     and behaviour change among women of reproductive age (15-49 years).~   "
62670|NCT02746588|"~     To be diagnosed with recurrent miscarriages, a couple might have a child, however experiences~     three or more miscarriages, primarily this happens during the first trimester.~      These miscarriages often needs medical evacuation or a D & C. Surgery or retained tissue~     increases the risk of complications as infection and/or adhesions, known as asherman~     syndrome, which may result in subfertility.~      Recently chronic infection in the endometrium has been proposed to contribute to the~     condition, as protocols including treatment with antibiotics have led to birth at term for~     some of these women.~      Using the very minimal invasive office hysteroscopy, the investigators aim to describe the~     uterine cavity in patients diagnosed with recurrent miscarriages regarding both abnormalities~     in the endometrium and chromic infection.~   "
62671|NCT02746575|"~     Perioperative cardiac adverse events [heart injuries caused by general anesthesia and~     surgical procedures] are a significant public health issue, with more than 60,000 deaths per~     annum in patients having surgery for non-heart related issues. There are virtually no~     evidence-based medical strategies for effective prevention of these events. Preoperative drug~     treatment with beta blockade drugs used for high blood pressure, perioperative therapy with~     lipid lowering drugs such as statins, alpha-receptor agonists such as clonidine used for high~     blood pressure, and aspirin have all been investigated as potential mitigating treatments,~     but without positive clinical outcomes and, in some cases, creating more hemodynamic~     instabilities that result in heart injury. In light of this, investigators propose to~     evaluate the safety and efficacy of using increasing doses of beta blockade drugs immediately~     after surgery and to assess the value of high-sensitivity cardiac troponin level testing of~     the blood in predicting those patients who would benefit most from perioperative beta blocker~     therapy.~   "
62672|NCT02746562|"~     The purpose of this study is to compare conventional fresh embryo transfer with a freeze all~     and transfer later strategy in assisted reproductive technology in terms of ongoing~     pregnancy rates, live birth rates as well as perinatal outcomes.~   "
62673|NCT02746549|"~     In this study we want to compare the accuracy of two methods to measure renal perfusion by~     MRI spin labelling technique: the first measurement done with the 1.5 T MRI versus the second~     one obtained with the 3.0 T MRI (Siemens MRI device).~      Additionally we want to compare the changes of renal perfusion caused by physiological~     stress. The used stress test is the cold pressor test done at the forehead.~   "
62674|NCT02746536|"~     Background: Commonly, patients with chronic obstructive pulmonary disease (COPD) present~     dyspnea, dynamic hyperinflation (DH) and important peripheral muscle deoxygenation when~     performing their activities of daily living (ADLs). The slow chest compression (SCC)~     technique is a physiotherapy strategy that could maybe reduce DH, dyspnea and peripheral~     muscle deoxygenation in patients with COPD. The aim of the study is to analyse the effects of~     SCC in DH, dyspnea and peripheral muscle deoxygenation induced by exercise tests.~      Design: Randomized cross-over study. Setting: The study will be conducted in an outpatient~     pulmonary rehabilitation program in Florianopolis, Brazil~      Subjects: Patients with COPD (GOLD B-D).~      Interventions: Patients will randomly receive or not the SCC after six-minute step test~     (6MST-SCC and 6MST-NonSCC) and after six minute walk test (6MWT-SCC and 6MWT-NonSCC)~      Main measures: At baseline and 1 minute after the tests, the inspiratory capacity (IC) will~     be assessed by the slow vital capacity (SVC) maneuver. At baseline, immediately after, and 1~     minute after the tests, the dyspnea score will be assessed. The physiological responses and~     the peripheral muscle deoxygenation will be assessed during the tests and 1 minute after~     them.~   "
62675|NCT02746523|"~     To investigate long term affects of multiple concussions on the cognition, balance,~     proprioception, and biomarkers in retired National Hockey League players~   "
62676|NCT02746510|"~     Background:~      Nowadays, despite a large number of studies about schizophrenia and genetics, clinical red~     flags for syndromic forms of schizophrenia remain poorly documented.~   "
62677|NCT02746497|"~     As a natural part of the menopause the ovaries production of sex hormones declines. This can~     lead to different menopausal related symptoms. About two-thirds of postmenopausal women~     experience hot flushes and 10-20% find these hot flushes very stressful.~      The aim of this study is to determine and evaluate the efficacy of acupuncture on menopausal~     symptoms; in particular hot flushes. The study will be a randomized controlled trial. Primary~     outcome is change in hot flushes. Secondary outcome is change in other menopausal related~     symptoms.~   "
62678|NCT02746484|"~     The Ability research project, funded in Italy within the Smart Cities and Smart Communities~     funding program (MInistry of University and Research, Operational Regional Programme,~     Lombardy, Axis 1, Operational Regional Programme - European Funding for Regional Development~     2007-2013), aims at developing and testing the efficacy and the impact of a Personal Smart~     Health Community able to provide innovative trajectories for people with cognitive~     impairment, putting them at the core of a continuous and intertwining treatment and support~     from both formal (e.g. physicians) and informal (e.g. near relatives) caregivers, with~     special focus on home-based care.~      Within this framework of the Ability project the investigators test the efficacy of the~     home-based motor-cognitive rehabilitation program delivered with two different approaches:~     the Ability platform versus the usual care program~   "
62679|NCT02746471|"~     The Reveal LINQ Registry will generate reliable long-term real world data of product~     performance, economic valuation, site-of-service procedural information.~   "
62680|NCT02746458|"~     The Rehabilitation Enhanced by Partial Arterial Inflow Restriction (REPAIR) Study will be~     conducted in a patient population of individuals recovering from a traumatic diaphyseal~     fracture of the femur. Although the intervention can be used for any patient with muscle~     weakness following trauma, the persistent thigh weakness that follows a femur fracture~     provides a perfect model for evaluating the effectiveness of the REPAIR protocol.~   "
62681|NCT02746445|"~     The purpose of this study is to continue to evaluate the long-term effectiveness of Magnetic~     EEG/ECG-Guided Resonance Therapy (MeRT) in children with Autism Spectrum Disorder (ASD). No~     active MeRT treatment will be performed in this study.~   "
62751|NCT02745509|"~     The investigators study aims to explore the potential function of extensive intraoperative~     peritoneal lavage in improving the overall survival and progression-free survival for locally~     advanced gastric cancer after curative resection.~      Hypothesis: Overall survival and progression-free survival of locally advanced gastric cancer~     are improved by extensive intraoperative peritoneal lavage.~   "
62682|NCT02746432|"~     Research Problem:~      Surgical stress induces inflammation and postoperative immuno-suppression, which are risk.~      factors for both post-operative complication and possible disease recurrence. Colorectal~     cancer is in the top 5 malignancies in the Kingdome and the highest incidence in males.~     Recurrent disease locally or distally occurs in 35% of patients and is the leading cause of~     death in these patients. Despite the new era of laparoscopic surgery, still surgical stress~     is present and equally traumatic to the conventional open colorectal resection, earlier~     studies showed no major differences in post-operative inflammatory and immunological~     reactions. The previous studies revealed the anti-inflammatory effects of the~     hyper-insulinimic euglycemic therapy. Benefits observed in both major liver resection and in~     cardiac surgery. The anti-inflammatory effect reduced the surgical stress and postoperative~     inflammation.~      The hypothesis is Can intraoperative hyper-insulinimic euglycemic infusion reduce post~     operative inflammation and immunomodulation in colon cancer patients undergoing a curative~     surgery?~      Research methodology Triple blinded randomized controlled study with estimated sample size of~     144 patients of non-metastatic colorectal cancer patients operated at King Saud University~     Medical city with a confirmed diagnosis of colon adenocarcinoma. Patients Consented will~     undergo computer randomization to receive intraoperative hyper-insulinimic normoglycemic~     infusion (experimental) or standardized insulin sliding scale and saline (control). A common~     preoperative and postoperative pathway with standardized management and pain control in both~     groups.~      Outcomes will be measured via a battery of laboratory test consist of routine labs,~     inflammatory markers and immunological markers to be repeated at fixed timed intervals. All~     patients will be followed by regularly for 5 years.~      Research objectives~      Primary outcomes to examine:~        -  The anti-inflammatory effects of intraoperative hyper-insulinimic euglycemic therapy in~          patients undergoing colorectal cancer surgery.~        -  The immunomodulatory effect of intraoperative hyper-insulinimic euglycemic infusion~      Secondary outcomes:~        -  Thirty days post-operative morbidity.~        -  Overall survival rate.~        -  Disease-free survival rate.~   "
62683|NCT02746419|"~     This study will test the safety and efficacy of the Vessix Renal Denervation system in the~     reduction of pain in patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD).~   "
62684|NCT02746406|"~     In a hospital setting, the self-measurement of intravesical pressure (SMIP) assessment will~     be conducted at full and empty bladder using the Peritron+ and a ruler-based manometry~     method. In the home setting a human factor/usability study will be conducted to measure the~     subject's ability to perform a successful SMIP assessment at full and empty bladder with the~     Peritron+. This study involves the use of the Peritron+, Air-Trap Tubing, a ruler and a clean~     intermittent catheter (CIC).~   "
62685|NCT02746393|"~     The San Francisco General Hospital (SFGH) Health Advocate Staff II Study is a Randomized~     Controlled Trial (RCT) that collects survey data and non-invasive biological data from~     caregivers and children visiting a pediatric urgent care center. Families will be randomized~     according to a pre-determined randomization schedule into one of two social needs-focused~     interventions (the Health Advocates Program or a 211 Information active comparator arm). All~     patients in the study will be followed over a six month period to capture information about~     changes in social needs, health and health care utilization.~   "
62686|NCT02746380|"~     This is a randomized, double-blind, parallel group, multicenter clinical study to evaluate~     the efficacy, safety, pharmacokinetics and immunogenicity of LBAL compared to Humira® in~     subjects with active Rheumatoid Arthritis despite Methotrexate therapy.~   "
62687|NCT02746367|"~     The purpose of this study is to validate a set of signatures, based on a panel of proteomic~     markers, that discriminate BDI, BDII, and MDD in people seeking treatment for a depressive~     episode.~   "
62688|NCT02746354|"~     The objective of this study is to engage patients with chronic pain and other key~     stakeholders in an iterative process of pilot-testing a validated patient generated~     instrument, the Measure Yourself Medical Outcome Profile (MYMOP), to support primary care~     encounters and provide a direct comparison between a strategy of incorporating patient~     reported outcomes into the package of care for complex pain patients and usual care. The~     specific aims of this phase of the project are to: 1) adapt the MYMOP for use in the primary~     care setting well-integrated into everyday practice flow, and 2) evaluate whether the~     utilization of the MYMOP data in routine primary care encounters results in improvements in~     patient symptoms and functioning over time as well as increased satisfaction with the visit~     for patients and primary care providers. To achieve Aim 2, the investigators will compare the~     reported outcomes and health care utilization from participating patients in this study for~     whom the MYMOP-based instrument will be used in routine clinical care to a matched group of~     chronic pain patients who will not receive the MYMOP-based assessment but will otherwise have~     similarly collected data. This also allows us to evaluate of the extent to which use of the~     tool adds patient-centered information to more conventional instruments. In addition to these~     two aims, for a third aim, the investigators plan to collect qualitative data from patients,~     their family members, Kaiser Permanente Northwest (KPNW) health care providers, and KPNW~     administrators to better understand the needs of this subpopulation of patients.~   "
62689|NCT02746341|"~     Evaluate the clinical progression in patients with MPS IIIA who are untreated with any~     investigational product and to obtain standardized assessments: neurocognitive, behavioral,~     sleep-wake habits and effect of MPS IIIA on the quality of life of patients and their~     families.~   "
62690|NCT02746328|"~     This is a multiple site, proof of concept feasibility study to describe the effect of GTx-024~     9 or 18 mg on physical function in female subjects, from protocol G200802, with ER+/AR+~     breast cancer.~   "
62691|NCT02746315|"~     This trial is conducted in China. The aim of this trial is to assess the safety and~     tolerability for Multiple s.c injection of HS-20004 in healthy Chinese subjects~   "
62692|NCT02746302|"~     This trial is conducted in China. The aim of this trial is to assess the safety and~     tolerability of HS-20004 in healthy Chinese subjects.~   "
62693|NCT02746276|"~     Children with severe malnutrition who are admitted sick to hospitals have a high mortality,~     usually because of infection. All children with severe malnutrition admitted to hospitals are~     treated with antibiotics. However, policymakers are not sure that the current antibiotics are~     the most effective. It is possible that the antibiotics that are currently used as~     second-line should be used first. Finding this out will need a large trial comparing~     different antibiotics. To prepare for such a trial the investigators first want to make sure~     that the doses given are correct for malnourished children. The investigators also want to~     check whether malnourished children more commonly carry resistant bacteria in their feces~     than well-nourished children. The study is important because the types of antibiotics and the~     doses needed to fight infection may be different in malnourished children because of the~     changes in their body due to malnutrition and the types of bacteria present.~   "
62694|NCT02746263|"~     The purpose of this study is to compare intravenous (IV) and oral acetaminophen for the~     treatment of acute moderate to severe pain in combination with standardized~     patient-controlled analgesia (PCA) in adult subjects following total knee replacement.~   "
62785|NCT02745067|"~     The primary objective of this study is to gain knowledge about the effectiveness of enhanced~     cognitive behavioral therapy (CBT-E) for anorexia nervosa (AN).~   "
62697|NCT02746224|"~     This is an interventional, controlled and randomized single-center clinical trial with~     patients diagnosed with colorectal cancer that will undergo laparoscopic left hemicolectomy~     or laparoscopic low anterior resection for rectal cancer.~      All patients included in the study (study 1) are randomized into two groups (group 1A and~     group 1B): in the group 1A the surgical technique initially dissects the inferior mesenteric~     vein (IMV) and in the group 1B the surgical technique initially dissects the inferior~     mesenteric artery.~      The patients who will undergo a colorectal anastomosis will be included in the study 2 and~     will be randomized to group 2A and group 2B: in group 2A the patients will have a~     latero-terminal colorectal anastomosis and in group 2B a termino-terminal colorectal~     anastomosis.~      Study hypothesis:~      Study 1: the surgical technique that initially dissects the IMV presents a greater number of~     total resected lymph nodes compared to the technique that initially dissects the IMA.~      Study 2: latero-terminal anorectal anastomosis has a better anorectal functional outcome than~     termino-terminal anorectal anastomosis.~      Primary outcome measures:~        -  Study 1:To compare the total number of resected lymph nodes and the distance to the~          surgical margins between the two arms (1A and 1B).~        -  Study 2: to compare the anorectal functional outcome at 12 months after surgery or~          ileostomy closure between the two arms (2A and 2B). The anorectal function will be~          assessed by the scores of the validated Colorectal Functional Outcome Questionnaire~          (COREFO) and the validated scale LARS (Syndrome anterior resection of the rectum).~      Secondary outcome measures:~        -  Study 1: to compare the duration of surgery, bleeding and need for surgical conversion~          between the two arms (1A and 1B). Another objectives are to compare the incidence of~          postoperative complications (measured by the Clavien-Dindo classification) and survival.~        -  Study 2: to compare the quality of life and anorectal functional outcomes at : 6, 12, 18~          and 24 months after intervention (or ileostomy closure) between the two arms (2A and~          2B). The anorectal function will be assessed by the validated COREFO questionnaire and~          the LARS scale. The quality of life will be assessed by the validated questionnaire of~          quality of life: SF-36. Another objective is to compare the incidence of postoperative~          complications assessed by the Clavien-Dindo classification and the incidence of~          anastomotic leakage.~   "
62698|NCT02746211|"~     A study to determine the infectious titre of an Influenza A (H1N1) (A/New Caledonia/20/99)~     virus for use in other Influenza challenge studies for the development of Influenza vaccines,~     antiviral agents and to better understand the host response to Influenza infection.~   "
62699|NCT02746198|"~     The aim of the study is to estimate the effect of a probiotic dairy drink on occurrence and~     duration of AAD and gastrointestinal symptoms during Helicobacter pylori (Hp) eradication~     therapy and during 4 weeks thereafter and calculating the sample size for a confirmatory~     study.~   "
62700|NCT02746185|"~     The study will compare the efficacy and safety of oral rivaroxaban and subcutaneous~     dalteparin in patients with cancer associated thrombosis. It is designed as a non-inferiority~     open label randomized multicenter trial with blinded adjudication of outcome events.~   "
62701|NCT02746172|"~     The aim of this research is to investigate the potential use of specific metrics in assessing~     the quality and optimising an individual's cochlear implant fitting. Assessment of the~     sensitivity and specificity of specific metrics that are potential predictors of inaccurate~     T-levels and C-levels is important to determining best methods for streamlined high quality~     fitting, providing the potential for feedback to the individual and clinic, as well as~     automated adjustments for optimisation. Ultimately the objective is to increase clinical~     capacity for managing both the installed base and new candidates for cochlear implantation.~   "
62702|NCT02746159|"~     The purpose of this Registry is to enroll patients presenting with clinical and hemodynamic~     abnormalities in native or synthetic (grafts) arteriovenous (AV) fistulae located in the arm.~     Subjects will be treated with the Lutonix DCB carrying the CE Mark per current IFU and~     followed clinically for a minimum of 12 months.~   "
62703|NCT02746146|"~     The main objective of this study is to show that the systematic use of a prognostic score as~     early as possible after the initiation of dialysis in patients over 70 years of age and with~     a good prognosis at 3 years of dialysis results in an increase in the number of entries on a~     kidney transplant waiting list at 12 months after the initiation of dialysis.~      This prospective assessment is carried out as part of a historico-prospective before-after~     study in parallel with a survey of changes in national practices over the same time period~     via a here-elsewhere type study.~      Historical data (i.e the. before period) will include incident dialysis cases during the~     calendar years 2013, 2014 and 2015 before the start of the prospective phase (i.e. after~     period, which is represented by the current declaration); since a preliminary study~     demonstrated that the data are comparable from 2011 to 2013, we will use the average of data~     thus obtained. Historical data will be retrieved from the REIN (The French Renal Epidemiology~     and Information Network) registry data and will be validated by investigators at each center.~   "
62704|NCT02746133|"~     The purpose of this study is to characterise the patient and disease profile under the~     influence of a protein-restricted diet supplemented with keto acids/amino acids (KA/AA),~     focusing on the progression of chronic renal insufficiency, calcium and phosphorus~     metabolism, nutritional status, patient compliance to diet and Ketosteril intake as well as~     the persistent dietary education to ensure compliance in a large group of pre-dialysis~     patients.~   "
62705|NCT02746107|"~     Randomized study concerning the effect of the number of risk diagrams (with treatment +/-~     without treatment), the period of stroke risk estimation (one year or five years) and the~     target of prescription (the patient with atrial fibrillation or the physician himself,~     imagining she/he has atrial fibrillation) on the intention to prescribe or not oral~     anticoagulation.~   "
62706|NCT02746094|"~     The primary objective of this study is to evaluate changes in erectile function (EF) before~     versus after 8 bi-weekly treatments of Low-Intensity Extracorporeal Shock Wave Therapy~     (LIESWT) via IIEF-EF (the Erectile Function domain of the International Index of Erectile~     Function) scores.~   "
62707|NCT02746081|"~     In patients with IDH1-R132X-mutant solid tumors treated with BAY1436032:~        1. Determine the safety, tolerability, maximum tolerated dose (MTD) or recommended phase II~          dose (RP2D) of BAY1436032;~        2. Evaluate the pharmacokinetic (PK) properties and pharmacodynamic (PD) effects of~          BAY1436032;~        3. Look for preliminary evidence of clinical efficacy in patients treated with BAY1436032;~        4. Evaluate effect of standard high-fat, high calorie meal on the PK of BAY1436032.~   "
62708|NCT02746068|"~     This is a randomized, double-blind, placebo-controlled, 24-week study to evaluate the~     efficacy and safety of AXS-02 in subjects with knee osteoarthritis associated with bone~     marrow lesions.~   "
62709|NCT02746055|"~     To determine the prevalence of 5 specific corneal dystrophies in a subgroup of patients~     seeking refractive surgery, and to use that information to inform them and their refractive~     surgeons of the presence of the corneal dystrophies so that they may make safer choices when~     considering refractive surgery.~   "
62710|NCT02746042|"~     To assess the efficacy of the herbal medicinal product Sinupret extract versus placebo in the~     treatment of chronic rhinosinusitis (CRS) in adults.~   "
62786|NCT02745054|"~     The goal of SOAR is to characterize the clinical and economic impact of clinicians' responses~     to major bleeding complications and pre-procedural concerns for bleeding risk in patients~     treated with oral anticoagulants (warfarin, anti-Xa orals, and anti-thrombin (IIa) orals) who~     present to the ED or in the hospital with acute illness or injury, with the eventual aim of~     informing the development of improved approaches to the management of OACs in the ED.~   "
62711|NCT02746029|"~     Heart murmurs are commonly discovered in young children during clinical encounters in general~     practice. Heart murmurs might signal a structural cardiac disease that need to be treated,~     such as atrial septal defect. Thus, children with heart murmurs are routinely referred to~     comprehensive cardiac examination at a paediatric hospital department featuring~     echocardiography ('gold standard'). However, the great majority of such murmurs are innocent~     or physiological; ie., they do not represent a cardiac disorder. The prevalence of such~     innocent murmurs during routine random auscultation is estimated at 30 %.~      It would be advantageous if patients with a heart disease to a greater extent could be~     identified at the general practitioners' office:~        -  Healthy children would not be exposed to comprehensive cardiac examination~        -  The burden on the family would subside.~        -  Scarce medical resources in highly specialized departments would be better allocated, to~          the benefit of patients with real heart disease.~      The primary aim of this study is to establish the predictive value of cardiac markers in~     children with heart murmurs. Secondary aims are a) To do a pilot study of pediatric cardiac~     ultrasound examination in general practice; b) To establish age-adjusted reference range for~     cardiac markers in children, and c) To explore aspects of cardiovascular physiology in~     children.~      The investigators will include a total of 500 children aged 4 weeks to 10 years who is~     consecutively referred to the Dept. of Paediatrics, Akershus University Hospital, for~     assessment of heart murmurs. All participants will be subjected to clinical examination,~     symptom assessment, pulse oximetry, blood sampling (for troponin T, proBNP and other~     biomarkers), ECG recording, and echocardiography. A randomized subgroup of children will also~     undergo echocardiography performed by a general practitioner who has not received formal~     training in pediatric cardiology. The value of possible predictors will be assessed through~     the construction of Receiver Operating Characteristics (ROC) curves, and calculation of~     negative predictive value.~   "
62712|NCT02746016|"~     This is a prospective, multi-center, single-arm study to evaluate the symptoms of formula~     intolerance in healthy term infants.~   "
62713|NCT02746003|"~     Background (brief):~        1. Burden:~           Excessive salinity is common in groundwater aquifers across south-western coastal~          Bangladesh. Higher adult mean systolic and diastolic blood pressure and increased risk~          of gestational hypertension has been observed among those who drank tube-well water with~          high sodium content.~        2. Knowledge gap:~           Managed Aquifer Recharge (MAR) systems, that inject freshwater into shallow aquifers,~          reduce drinking water salinity, have been successfully installed in the south-western~          area, providing year-round freshwater. However, the health benefits and risks of MAR~          water have not been measured.~        3. Relevance:~      If drinking MAR water can reduce hypertension in adults and pregnant women, while showing~     minimal risk of microbiological and chemical contamination, scale up can be considered.~      Hypothesis (if any):~      Mean systolic and diastolic blood pressure will be lower among the adult population who drink~     MAR water compared to people drinking saline or brackish groundwater Objectives: To determine~        1. If providing access to MAR water for drinking and food preparation reduces blood~          pressure among the adult population > 20 years of age.~        2. If providing access to MAR water for drinking and food preparation during pregnancy can~          reduce blood pressure among pregnant women.~        3. If MAR water is contaminated with E coli and fecal coliforms.~        4. Whether the MAR water is contaminated with dissolved constituents mobilized from aquifer~          sediments that are known to be harmful to human health.~      Methods:~      A stepped-wedge RCT will be conducted among communities before and after the intervention~     roll out. Study investigators will collect baseline information from all sites in the first~     monthly block (step) when no one will drink MAR water. There will be promoters who will~     convey messages regarding exclusive use of MAR water for drinking and cooking, at home and~     elsewhere. Measurements will be made by trained research assistants once every month. MAR~     water, pond water, groundwater and household stored water samples will be collected and~     tested once every month.~   "
62714|NCT02745990|"~     In the ELGAN (Extremely Low Gestational Age Newborn) study, abnormal brain structure and~     function were associated with intermittent or sustained systemic inflammation (ISSI). Since~     EPO has anti-inflammatory properties in the kidney and in muscle as well as growth/trophic~     properties. Based on its potential for neuroprotection, the prospective randomized and masked~     study was designed to determine whether rhEPO （500u/kg) was also effective in improving~     developmental outcomes for extremely low gestational age newborns.~   "
62715|NCT02745977|"~     Breast feeding is the most nutritious form of nourishment in infants and is recommended for~     at least the first four months of life. Breast fed infants may develop milk protein~     intolerance. The management of breast milk protein intolerance differs from that of cow's~     milk protein intolerance in formula fed infants. Because breast milk is considered by many to~     be nutritionally superior to formula and results in maternal infant bonding mothers are often~     told to continue breast feeding. Despite the lack of evidence based data to support or refute~     the modification of the mother's diet, it is suggested that they eliminate their own intake~     of dairy products strictly and avoid supplementing with a cow's milk based formula.~     Investigators are doing this study to demonstrate that the deletion of dairy from the diet of~     a breast feeding mother will not cause breast milk protein intolerance to resolve.~   "
62716|NCT02745964|"~     The purpose of this study is to investigate and compare the incidence of the postoperative~     sore throat between LMA supreme and I-gel.~   "
62717|NCT02745951|"~     The HELICOPTER-1 Trial is a single centre pilot study to determine the feasibility of~     administering Heliox in cardioplegia during cardiac surgery and whether it has the potential~     to reduce the incidence and severity of myocardial ischemia during and after cardiac surgery.~   "
62718|NCT02745938|"~     Mitochondrial disorders are a group of inherited disorders causing malfunctional~     mitochondria. Mitochondria are found in every cell of the body, and the disorders therefore~     give symptoms from every tissue, especially those with high energy needs as the brain, heart~     and muscles. The symptoms are often unspecific in terms of muscle weakness and fatigue, which~     delays the first contact to the doctor and further delays the diagnosis.~      The aim of this study is to investigate if it is possible to use GDF-15 (Growth and~     Differentiation Factor 15) as a biomarker for mitochondrial disease and compare the results~     with that of healthy controls, metabolic myopathies and muscular dystrophies. The~     concentration relative to exercise will further be investigated.~   "
62719|NCT02745925|"~     The main iron regulatory protein in the human metabolism is hepcidin. In normal weight,~     healthy subjects, hepcidin is regulated through the iron status of the body: low iron status~     results in low hepcidin concentrations, which facilitates dietary iron absorption. In~     obesity, which is an inflammatory state, hepcidin concentrations are increased and iron~     absorption is reduced despite low iron stores, leading to iron deficiency over time. Whether~     lowering the chronic low-grade inflammation during a limited treatment period and thereby~     lowering hepcidin concentration can improve iron absorption is uncertain.~   "
62720|NCT02745912|"~     The purpose of this study is to determine the effect of multiple oral doses of~     naltrexone/bupropion on the pharmacokinetics (PK) of a single oral dose of metformin.~   "
62721|NCT02745899|"~     the investigators hypothesis is that milk consumption, either in the acute phase and through~     prolonged exposure, does not cause or increase respiratory symptoms or airway inflammation.~     the investigators aim to objectively prove this by examining respiratory symptoms and signs~     and objectively measuring parameters of airway inflammation and hyper responsiveness after~     consumption of cow milk or soy milk substitute.~   "
63146|NCT02740361|"~     This is an international, multicenter, randomized controlled trial of an internet-based CBT~     intervention for depression (Deprexis) conducted in five MS centers in the US and Germany.~     The trial consists of a three-arm primary trial phase and an extension phase targeted at~     maintenance.~   "
62722|NCT02745886|"~     The fact that metformin treatment has been associated with reduced risk of cancer and~     cardiovascular disease raises the possibility of a beneficial role of metformin for other~     age-related diseases. The actions of metformin resemble the effects of calorie restriction~     (CR) to some extent, and microarray analyses have shown that metformin induces a gene~     expression profile that aligns with that of CR in animal. The aim of the study is to~     investigate whether metformin treatment can induce dietary restriction-like state in human.~      Sixty overweight subjects will be included in this study, and participants will be divided 3~     groups (20 cases in each group)including metformin group (0.85, twice daily), standard diet~     group, and CR group. All subjects will be treated 6 months. At the end of this study, blood~     samples and muscle samples will be obtained.~   "
62723|NCT02745873|"~     The toxic nature of lead has been recognized ubiquitous for than 2,000 years and today it is~     a persistent and common environmental contaminant in most parts of the world. Vitamin C is a~     strong antioxidant and a metabolic co factor playing an important role in many biological~     processes and biochemical functions (hydroxylation reactions). The research objective is to~     assess the effect of oral ascorbic acid supplementation 500mg and 250 mg once a day for 4~     weeks on Blood Lead level among school going urban adolescents, using a cluster randomized~     trial study design. Ascorbic Acid (vitamin C) 250 and 500 mg will be administered in two~     study arms.~   "
62724|NCT02745860|"~     Clinical study in healthy adult subjects to compare the adult tablet of selexipag with the~     tablet developed for children.~   "
62725|NCT02745847|"~     The safety and efficacy of re-irradiation with stereotactic body radiotherapy for relapsed~     pancreatic cancer will be evaluated.~   "
62726|NCT02745834|"~     Case-control study to evaluate gait parameters during different conditions between patients~     who suffer from chronic ankle instability and healthy individuals.~   "
62727|NCT02745821|"~     Comprehensive assessment of coronary physiology (fractional flow reserve (FFR), coronary flow~     reserve (CFR) and index of microcirculatory resistance (IMR)) in patients with diabetes~     mellitus and coronary artery disease (CAD).~   "
62728|NCT02745808|"~     The intent of this clinical study is to answer the questions: 1) is the proposed treatment~     feasible; 2) is treatment effective in improving the disease pathology of patients with~     diagnosed diabetic erectile dysfunction.~   "
62729|NCT02745795|"~     The objective of the study is to investigate the efficacy of motivational interview~     intervention with adolescent students at a school environment on the adhesion to a~     therapeutic plan to loose weight.~   "
62730|NCT02745782|"~     This study sought to comprehend the relationship between syncope and dental related therapy.~     If the relationship between dental related therapies and syncope is proved, clinical dentists~     will be remained to monitor changes of patient's blood pressure during root canal procedure.~   "
62731|NCT02745769|"~     The main purpose of this study is to evaluate the safety of ramucirumab in combination with~     other targeted agents in participants with advanced cancers.~   "
62732|NCT02745756|"~     This study adds an experimental treatment with another type of cells, called dendritic cells.~     It is hoped that these cells may stimulate the immune system to react against neuroblastoma~     in much the same way that vaccines cause the immune system to react to certain viruses and~     bacteria. The physicians conducting this study have observed from previous research that~     neuroblastoma cells can be recognized by the immune system, and that they can be destroyed by~     immune cells.The main goal of this study is to see if giving participants this additional~     anti-Neuroblastoma vaccine reduces the risk of relapse following the Hematopoietic Stem Cell~     Transplant.~   "
62733|NCT02745743|"~     The purpose of this study is to identify the most appropriate dose that can be safely~     administered and that can have an effect on blood cancer cells. Once that safe dose is~     identified, additional patients will be asked to join the study to further evaluate the~     safety and effectiveness of the study drug. The study will also investigate the~     pharmacokinetics (study of what the body does to the drug), as well as pharmacodynamics~     (study of what the drug does to the body), which may provide information about the effects of~     BAY 1251152. The study will also measure some biological markers (markers of biological~     activity in your body) that can be used to predict the response and safety of the proposed~     treatment.~   "
62734|NCT02745730|"~     Resting state functional magnetic resonance imaging (rsfMRl) of the brain is used to measure~     pleasantness after consumption of four different milkshakes with added sugars or sweeteners.~   "
62735|NCT02745717|"~     Aim: To evaluate if additional cord blood transfusion could accelerate the hematopoietic~     reconstitution in severe aplastic anemia(SAA) patients receiving immunosuppressive therapy~     (IST).~      Study design: open-labed, prospective, multicenter, randomized control study Number of~     subjects: 60 each group~      Treatment:~      IST group: ATG (Thymoglobuline®, Genzyme) 3.5mg/kg/d×5d plus oral cyclosporine A (CSA) Cord~     blood transfusion group: In addition to the same dose and course of ATG and CSA , one unit of~     cord blood having no more than 2 HLA-A, B or DRB1 mismatches is transfused 24h after last~     dose of ATG administration.~   "
62736|NCT02745704|"~     As HBsAg clearance is uncommon in chronic hepatitis B (CHB) patients on nucleoside analogues~     (NAs) therapy. The purpose of this study is to optimize HBsAg clearance in CHB Patients with~     sequential treatment of pegylated interferon alpha and NAs.~   "
62746|NCT02745574|"~     Laparoscopic surgery is becoming a major procedure, owing to smaller incisions, shorter~     hospitalizations, and less post-operative pain as compared with traditional laparotomies.~     However, there is marked interindividual variability of post-operative shoulder-tip pain~     following laparoscopic surgery. The incidence of shoulder pain varies from 35% to 80% and~     ranges from mild to severe. In some cases, it has been reported to last more than 72 hours~     after surgery.~      The hypothesis of post-operative shoulder-tip pain is that carbon dioxide induced phrenic~     nerve irritation causes referred pain to C4. Therefore, we should try to do is that if we~     could reduce carbon dioxide retention in the pelvic cavity.~      This clinical controlled trial is tried to find out the practical and clinical maneuver to~     reduce post-operative should-tip pain following laparoscopic surgery.~   "
62747|NCT02745561|"~     Endostatin inhibits the pro-angiogenic action of basic fibroblast growth factor and vascular~     endothelial growth factor in esophageal cancer.This study aims at assessing the efficacy and~     safety of endostatin combined with concurrent chemoradiotherapy with Oxaliplatin in~     esophageal cancer patients.~   "
62737|NCT02745691|"~     The aim of the Phase 4 study is to test the scale structure, reliability, responsiveness to~     change and validity of the EORTC QLQ-LC29 in conjunction with the EORTC QLQ-C30 in patients~     diagnosed with lung cancer. Participants will be enrolled in three groups according to their~     primary therapy (A. Surgery, B. Radiochemotherapy, C. Targeted therapy, D. Immunotherapy).~     Various combinations of therapies are permissible, resulting in a total of eight subgroups~     (A.1 Surgery alone and/or before any adjuvant therapy, A.2 Surgery [late effects], B.1~     Chemotherapy alone, B.2 Radiotherapy alone, B.3 Sequential radiochemotherapy, B.4 Concurrent~     radiochemotherapy, C.1 Targeted therapy alone, C.2 Targeted therapy in combination with any~     other therapy, D. Immonotherapy).~      According to sample size calculations we will include a total of N = 450 patients. N = 120 of~     these patients will be asked to fill in the questionnaires at a second time point, of which a~     subgroup of n = 60 will be subjected to test-retest analyses (patients who are clinically~     stable and indicate no change on an anchor question over the two assessment points), and~     another n = 60 will be subjected to test-retest analyses (those who indicate a change to the~     worse or to the better).~      Standard psychometric analyses will be employed to evaluate the hypothesized scale structure~     of the QLQ-LC29 and its internal consistency, convergent and discriminate validity, as well~     as test-retest reliability and responsiveness to change.~   "
62738|NCT02745678|"~     The purpose of this study is to investigate a novel thermosensitive topical gel formulation~     for the treatment of inflammatory bowel disease (IBD), specifically ulcerative colitis.~   "
62739|NCT02745665|"~     This is a pilot study with the purpose of measuring vascular function, assessed by evaluating~     arterial stiffness (pulse wave velocity and augmentation index) and endothelial function~     (flow mediated dilatation), in elite/amateur symptomatic male cyclists with unilateral~     Endofibrosis (EF), compared to asymptomatic males cyclists and to a group of age matched~     healthy males (non-athletes).~   "
62740|NCT02745652|"~     Carpel tunnel syndrome (CTS) is very common complain during pregnancy with high percentage to~     continue postnatal. Conservative treatment is more recommended in these cases. There are many~     physical therapy modalities proposed to treat CTS without knowing which modality is better~     than the other. So the aim of this study to compare the effect of two modalities in treating~     CTS in postnatal females.~   "
62741|NCT02745639|"~     This was a prospective phase II study on patients with locally advanced rectal cancer or~     local recurrence, to evaluate the pathological response and resectability of a neoadjuvant~     treatment based on the use of a combined treatment with VMAT-SIB and two drugs chemotherapy (~     XELOX).~   "
62742|NCT02745626|"~     Orthodontic treatment has been traditionally carried out with fixed appliances involving the~     use of stainless steel brackets and archwires. The challenge has been to move teeth and their~     roots effectively while minimizing iatrogenic damage such as root resorption and gingival~     inflammation. In recent years, with the development of new appliances and brackets such as~     self-ligating brackets and clear aligners there have been reports of improved periodontal~     status, less iatrogenic root damage and improved hygiene during treatment. Although these~     treatment modalities have been rapidly accepted in clinical practice, both clinical and basic~     science research data regarding their overall biological compatibility to support higher~     levels of evidence based dentistry (e.g, randomized clinical trials) is lacking. In other~     words, their advantages and disadvantages in this regard have not yet been scientifically~     evaluated. Such quantification will provide invaluable information for improvements in these~     treatment modalities.~      A randomized controlled clinical trial will be conducted with strict inclusion and exclusion~     criteria to test the following hypothesis (H) up to 18 months into treatment:~      H-1: There is no difference in the amount of root resorption caused by the three different~     appliances.~      H-2: Gingival health is not affected by the 'type of appliance' being used to correct the~     malocclusion.~      H-3: There is no difference in the amount of bacterial count and the type of appliance being~     used for orthodontic treatment.~      The hypothesis will be tested with the following specific aims (SA):~      SA-1: To investigate the amount of orthodontically induced inflammatory root resorption~     generated by treatment.~      SA-2: To evaluate the periodontal health of the patients with the different appliance~     systems.~      SA-3: To determine the changes in Streptococcus mutans and total bacterial counts contained~     in the plaque of orthodontic patients.~      SA-4: To ascertain whether there is an association between the microbial count and the type~     of appliance being used for orthodontic treatment~   "
62743|NCT02745613|"~     This study investigates weather a family history of type 2 diabetes affects exercise induced~     improvements in insulin sensitivity in the hispanic population~   "
62744|NCT02745600|"~     The main objective of the project is to bring the existing radio frequency ablation (RFA)~     model for liver cancer treatment (Project IMPPACT, Grant No. 223877, completed in February~     2012) into clinical practice. Therefore the project will pursue the following objectives:~      i) to prove and refine the RFA model in a small clinical study; ii) to develop the model into~     a real-time patient specific RFA planning and support system for Interventional Radiologists~     (IR) under special consideration of their clinical workflow needs; iii) to establish a~     corresponding training procedure for IR's; iv) to evaluate the clinical practicality and~     benefit of the model for use in the routine workflow in a user survey and expert forum.~   "
62745|NCT02745587|"~     At least 40% of the patients with prostate cancer (PC) present with positive lymph nodes~     (N1). The optimal treatment strategy for these patients remains controversial. Although~     androgen deprivation therapy (ADT) is still often initiated as only treatment, the results~     are disappointing. Recent studies support the use of more aggressive therapies including~     external beam radiotherapy (EBRT) and ADT. The retrospective studies supporting the~     additional use of EBRT in N1 PC patients are however not conclusive regarding to the extent~     of radiation field.~      Even after an EPLND, there might be a role for pelvic EBRT in irradicating microscopic~     disease. However pelvic irradiation irrevocably results in increased toxicity. Moreover, in~     node negative (N0) PC patients the addition of pelvic EBRT has not resulted in improved~     outcome in randomised trials. However in the setting of Tumor Node Metastasis pathological~     stage (p)N1, proven on pathological examination, PC patients this has never been evaluated so~     far. This trial aims to answer the question whether or not pelvic EBRT is beneficial in~     pathological N1 PC patients. It is also important to realise that not all pathological N1 PC~     patients have similar outcome. There is a significant impact of number of positive lymph~     nodes on outcome, with two positive nodes being suggested as a significant cut-off value in~     predicting survival in pathological N1 PC patients. By stratifying the patients according to~     the number of lymph nodes involved this study will add to the proper selection of those~     patients who will benefit most of pelvic EBRT and avoid toxicity in patients who have no~     benefit of pelvic EBRT.~      Additionally, small RNAs constitute potentially valuable markers for the diagnosis,~     prognosis, and therapeutic choices in PC patients. Blood samples will be collected to examine~     the potential role of miRNAs as a biomarker and to develop a prognostic signature for~     clinical relapse-free survival.~      The results of this trial will serve as a base for developping new trials in order to~     optimise the treatment of patients with pathological N1 PC.~   "
62748|NCT02745548|"~     In order to better understand radiation-induced lung toxicity, the investigator proposes a~     novel functional avoidance approach that incorporates central as well as peripheral BSS~     segments in the treatment planning process in order to quantify and account for their~     respective radiosensitivities. Specifically, the investigator proposes a systematic study~     that involves acquiring pre- and post-SAbR high-resolution CT and SPECT V/Q scans from lung~     cancer patients who receive radiotherapy, followed by auto-segmentation of the BSS elements~     using virtual bronchoscopy.~   "
72907|NCT02612662|"~     This is a first-in-human (FIH) study designed to evaluate the safety, tolerability, and~     pharmacokinetics (PK) of AZD4076 tetracosasodium in healthy male subjects at increasing~     single doses.~   "
62752|NCT02745496|"~     The clinical trial aims to address the critical challenge of differentiating aggressive from~     indolent prostate cancers by correlating prospectively collected MultiParametric (MP)~     Magnetic Resonance Imaging (MRI) data (index test) with the histopathology of radical~     prostatectomy specimens (reference standard).~      The study design incorporates pre-biopsy MRI, routine standard of care Transrectal Ultrasound~     guided (TRUS) biopsies and MRI/Ultrasound (US) image fusion techniques to guide biopsies to~     the suspicious areas identified by MRI.~      The hypothesis is that MP-MRI will allow pre-treatment determination of prostate cancer~     aggressiveness and MRI/US image fusion is expected to accurately co-locate cancer foci within~     the prostate gland for guiding biopsies.~      Pre-treatment prediction of Gleason grade as a marker of cancer aggressiveness will better~     inform clinicians and patients to improve risk stratification and facilitate decision making~     on subsequent treatment.~      Image fusion will allow accurate targeting of the most suspicious areas on MP-MRI for biopsy,~     which could obviate the need for multiple biopsies.~   "
62753|NCT02745483|"~     The purpose of this study is to compare the therapeutic outcomes and safety of the study~     patients who received radiofrequency ablation (RFA) using separable clustered electrodes with~     those of a matched historical control group who had received RFA using multiple~     internally-cooled electrodes.~   "
62754|NCT02745470|"~     The aims this study is to explore the effect of a GLP-1 receptor agonist on the degree of~     brain activation and connectivity obtained by functional magnetic resonance imaging in lean~     and obese type 2 diabetes~   "
62755|NCT02745457|"~     Background: Growth impairment is commonly seen in children diagnosed with inflammatory bowel~     diseases (IBD), mainly those with Crohn's disease (CD). There is general consensus in the~     literature that body composition, composed of fat mass and lean mass is altered in children~     with IBD compared with controls. Evidence regarding the effect of different therapeutic~     approaches on body composition in children with IBD is scarce and inconsistent. Furthermore,~     most studies used anthropometric measures and dual energy X-ray absorptiometry (DEXA) for~     body composition assessment, while information on the usefulness of air displacement~     plethysmography (ADP) for this assessment is lacking.~      Objectives: To assess body composition in children with IBD by ADP and DEXA at diagnosis and~     at various intervals during follow up.~      Design: A prospective cohort study. Setting: Pediatric gastroenterology institute, Schneider~     Children's Hospital.~      Participants: Children 6 year to 17 years who are diagnosed with either CD or ulcerative~     colitis (UC).~      Main outcome measures: Accuracy of ADP in comparison to DEXA and percentage of fat mass and~     lean mass at diagnosis and during treatment.~      Secondary outcome measures: Correlation of body composition to skin fold, mid arm~     circumference measurements, BMI, inflammatory markers, gender, disease activity and physical~     activity.~   "
62756|NCT02745444|"~     The key objective of this pilot study is to assess the molecular mechanisms of renal~     pre-conditioning by a one-week low-calorie diet in humans.~      The protective effect of the low-calorie diet and also of the protein-restriction in donor on~     transplant qualities and functions in receptor will also be investigated.~      Analysis of transcriptome, lipidome, metabolome, epigenome, proteome und phosphoproteome~     through tissue samples as well as blood samples for comparison of low-calorie diet,~     protein-restriction and no-diet groups.~   "
62757|NCT02745431|"~     The current study aimed to investigate oxytocin effect on the response after the experience~     of being liked or disliked.~   "
62758|NCT02745418|"~     Caucasian male and female participants age 18 years of age and older will be enrolled in this~     study if they have known birch or peanut allergies or known to be non-atopic. Participants~     will undergo skin testing to confirm their allergies if not completed in the last 12 months.~     Medications and medical history will be captured with a focus on atopic disorders.~     Participants will undergo birch and peanut patch testing to assess penetration and if~     potential correlation exists with filaggrin genotyping and phenotyping. Blood samples will be~     drawn from participants and DNA isolated for genotyping of null mutations in filaggrin.~   "
62759|NCT02745405|"~     This study examined how wearing a fat suit might lead individuals to experience the negative~     effects of weight based stigmatization, including psychological, behavioral, and~     physiological consequences. It also aimed to test using the fat suit as a possible~     intervention tactic to reduce weight stigma.~   "
62760|NCT02745392|"~     This is a randomized, double-blind, multi-center, parallel-group study designed to compare~     the safety and efficacy of a range of doses of ZP-Zolmitriptan intracutaneous microneedle~     systems to placebo.~   "
62761|NCT02745379|"~     In this study the buccal fat pad derived stem cells (BFPSCs) will be harvested from buccal~     fat pad tissue of patients receiving maxillary sinus augmentation. In the test group the~     patients receive a combination of platelet rich fibrin (PRF) and freeze dried bone allograft~     (FDBA) (SureOss, Hansbiomed, Korea) loaded with BFPSCs. The results will be evaluated by cone~     beam computed tomography (CBCT)and hematoxylin and eosin staining in 6 months.~   "
62762|NCT02745366|"~     In this study the buccal fat pad derived stem cells (BFPSCs) is harvested from buccal fat pad~     tissue of the patients receiving posterior mandible augmentation. In the test group the~     patients receive a combination of platelet rich fibrin (PRF) and freeze dried bone allograft~     (FDBA) (SureOss, Hansbiomed, Korea) loaded with BFPSCs. The control group receivesFDBA~     (without any cells)+PRF. In all the groups the combination are placed between the recipient~     site and the block graft obtained from lateral ramus. The results will be evaluated by cone~     beam computed tomography (CBCT)and hematoxylin and eosin staining in 6 months.~   "
62763|NCT02745353|"~     The purpose of this study is to compare the effect of naloxegol versus the patient's usual~     care in treating opioid-induced constipation, as well as the effect on the patient's quality~     of life and how much pain is experienced. Also, the purpose of this study is to compare~     whether treatment with naloxegol versus usual care has any impact on the number of hospital~     or clinic visits or telephone calls to the patient's physician that are related to~     constipation, and to determine the patient's preference for continuing to receive naloxegol~     as treatment for opioid-induced constipation.~   "
62804|NCT02744820|"~     The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of~     multiple oral doses of GMC-252-L-Lysine salt (GMC-252) in healthy subjects and type 2~     diabetics.~      The secondary objective is to explore the effect of multiple oral doses of GMC-252 on~     pharmacodynamic(PD) parameters in type 2 diabetics.~   "
62764|NCT02745340|"~     Acetate is the primary acidifying solution used in bicarbonate-based hemodialysis worldwide.~     It has been published in small trials or case series that the addition of acetate is~     associated with a rise in nitric oxide production of vascular smooth muscle cells,~     endothelial cells and myocardial cells as a sign of vascular dysfunction. Furthermore~     clinical side effects of dialysis e.g. nausea, malnutrition, intradialytic blood pressure~     drops, induction of proinflammatory cytokines and activation of complement and leukocytes~     have been described with acetate.~      Citrate on the other hand was associated with: Acid-base disorders (metabolic alkalosis),~     Disturbances of the calcium homeostasis (Hypocalcemia), but also anti-inflammatory effects.~     Both dialysate additives (citrate and acetate) are commercially available and are used world~     wide in dialysis centers.~      The investigators hypothesize that substitution of acetate by citrate reduces the~     cardiovascular risk (measured by a change in the surrogate parameter of pulse wave velocity~     and Augmentation index) and might improves quality of life in the participants. Furthermore~     the investigators speculate that citrate in the dialysis solution could reduce systemic~     inflammation in the participants of the study.~   "
62765|NCT02745327|"~     The purpose of this study is to assess the impact of small intestine bacterial overgrowth~     (SIBO) on childhood nutritional status, growth, and oral vaccine efficacy.~   "
62766|NCT02745314|"~     BACKGROUND.- The frailty syndrome (FS) associates an increase in morbidity and mortality in~     the elderly patient. When severe and symptomatic, aortic stenosis (AS) is a disease with poor~     prognosis, the most frequent cause of heart surgery in the elderly and associates high health~     costs. No variables have been identified as determinants of morbidity and mortality of these~     patients and there are not algorithms developed for treatment decision-making in this~     particular population. The FS as a functional reserve indicator could be a prognostic and~     interventional treatment tolerance marker, and should be included in the selection of~     patients for surgical treatment. The FS and cardiovascular disease (CVD) share biological~     substrates among which an inflammatory state associates poor prognosis.~      OBJECTIVES .- To evaluate the effectiveness of the diagnosis of FS to characterize the~     prognosis of elderly patients with severe symptomatic AS representative of clinical practice.~     In addition, to examine the contribution of an inflammatory state to the relationship of FS~     with the prognosis of severe, symptomatic AS.~      METHODS .- Prospective study during 12 months of 200 patients > 74 years old with severe~     symptomatic AS. During the index visit the main clinical characteristics will be recorded and~     in addition we will perform a comprehensive geriatric assessment, FS assessmet according to~     Fried et al criteria (strength, walking speed, physical activity, fatigue, unintentional~     weight loss) and determination of inflammatory markers (C-reactive protein and~     interleukin-6). During follow-up, measures of functional impairment (basic and instrumental~     activities of daily living, walking speed and timed set up & go test), hospitalizations,~     death and quality of life will be determined.~   "
62767|NCT02745301|"~     To assess the persistence of bladder cancer-specific biomarkers in urine collected~     pre-operatively, in resected cancer tissue, and in urine collected post-operatively. A panel~     of sensitive and specific bladder cancer biomarkers will be used to establish a signature of~     disease in pre-operative patients with a positive diagnosis for bladder cancer by current~     standard of care (e.g., in-office cystoscopy, OR cystoscopy). The specificity of these~     markers will be assessed, as well as the degree of non-specific signal attributable to other~     sources of biomolecules, by analyzing resected tumor tissue for the same biomarkers. Finally,~     post-operative urine will be assessed for the presence of these markers. To the extent this~     biomarker panel can be determined to be specific and sensitive, it may serve as an indicator~     of the degree to which the surgical intervention successfully eradicated the underlying~     disease. The investigators also aim to assess the stability of a biomarker signature in urine~     but evaluating several patient specimens over various time points throughout the day.~   "
62768|NCT02745288|"~     Mandibular resection which is an important component of maxillofacial cancer surgery is an~     extremely painful procedure associated with severe sympathetic response needing high doses of~     opioids. Inferior alveolar nerve block is a common nerve block used by dentists for~     mandibular dental extractions. The aim of this trial is to study the effect of this block for~     intraoperative analgesia in maxillofacial cancer surgeries requiring unilateral mandibular~     resection.~   "
62769|NCT02745275|"~     Canadians are living longer than ever before. However, many in our society age with long term~     chronic medical conditions which have a major impact on their need for healthcare, their~     quality of life and well-being. Encouragement of lifestyle practices which promote healthy~     aging and self-management techniques to deal with chronic disease is important in improving~     peoples' well-being~      The purpose of this study is to study the impact of peer delivered education and support for~     seniors living in the community to see if training given to other seniors improves healthy~     ageing behaviours and their health literacy.~   "
62770|NCT02745262|"~     The main objective of the study is to evaluate the overall survival and disease-free survival~     in breast cancer patients under 40 years old. They underwent controlled ovarian stimulation~     (COS) for fertility preservation versus women of the same age, type and stage of breast~     cancer, who have not been subjected to COS.~   "
62771|NCT02745249|"~     Inadequate maternal nutrition is likely to undermine the potential impact of infant and young~     child feeding (IYCF) improvements made in the Alive & Thrive (A&T) first phase because it is~     linked to poor fetal growth leading to small-for-gestational age and pre-term newborns. These~     babies do not respond to growth promoting feeding practices as well as normal newborns do. In~     Phase 2, Alive & Thrive decided to focus on integrating a package of maternal nutrition~     interventions in a large-scale maternal, newborn and child health program (MNCH). This~     proposed evaluation aims to assess the feasibility of integrating maternal nutrition~     interventions into an existing MNCH platform in Bangladesh, using a cluster-randomized~     evaluation design.~   "
62781|NCT02745119|"~     This multicenter open-label extension study is designed to evaluate the safety and~     tolerability of lampalizumab intravitreal injections in participants with GA secondary to~     age-related macular degeneration (AMD) who completed 96 weeks of treatment in Studies GX29176~     (NCT02247479) or GX29185 (NCT02247531). The extension will enroll participants from the~     parent studies who received investigational lampalizumab, as well as lampalizumab-naive~     participants exposed to sham comparator. All participants will receive open-label~     lampalizumab in the present study.~   "
62772|NCT02745236|"~     Atrial fibrillation (AF) is the most common heart rhythm disease characterized by an~     irregular heart rhythm of the top part (atria) of the heart. It may cause unpleasant symptoms~     as well as increases the person's risk of stroke and heart failure. With an ageing~     population, increasing rates of AF and limited access to specialists, new methods of care,~     like nurse practitioners (NP) need to be assessed to meet patient specific needs and provide~     sustainable care.~      The objective of the project is to evaluate the effect of Nurse Practitioner-led care in~     people with AF on their quality of life.~      The Canadian Healthcare system is overwhelmed, with increasing costs and wait times.~     Contributing to these issues, is AF is the most common arrhythmia accompanied with costly~     complications including stroke and heart failure. Currently family or emergency room~     physicians ask general cardiologists or specialized cardiologists, to provide care to~     patients with AF. Unfortunately, there is limited access to their services. NP's are nurses~     who have taken extra education at University to treat patients and prescribe medications.~     This research project involves an NP who has specialized training in AF patient management.~      By utilizing an NP to provide care for patients with AF, the investigators hope to improve~     patient's quality of life and satisfaction with care. This may also reduce complications of~     AF.~   "
62773|NCT02745223|"~     A study to establish safety, tolerability, and efficacy of PresbiDrops (CSF-1) in presbyopic~     subjects.~   "
62774|NCT02745210|"~     Despite the decline in fatal traumatic brain injury (TBI) incidence in recent years, TBI~     morbidity remains a public health challenge and is the leading cause of disability in the~     United States To combat these effects, new research is needed to identify mechanisms of~     injury that will lead to potential targets for therapeutic interventions that improve~     neurological outcome. One promising area of research is the cerebral metabolic dysfunction~     following TBI. Studies of post-traumatic cerebral metabolism have shown that cerebral~     metabolic rate of glucose (CMRglc) decreases for a period of days, weeks or months after~     injury with the duration and degree of hypometabolism correlating to level of consciousness~     and a strong predictor of long-term neurological outcome. However, specific changes in~     intermediary carbohydrate metabolic pathways have not yet been identified. In addition, the~     role of astrocyte metabolism in the post-injury metabolism has not been studied. This study~     uses in vivo 13C magnetic resonance spectroscopy (MRS) at 3 Tesla, a novel method in the~     clinical study of TBI, to non-invasively study the metabolic fate and flux of glucose~     (metabolized in both neurons and astrocytes) and acetate (metabolized in astrocytes) through~     metabolic pathways during the hypometabolic period. In addition, the investigators will study~     the association of decreased cerebral perfusion with changes in glucose and acetate~     metabolism following TBI, as changes in cerebral perfusion could profoundly affect cerebral~     metabolism by limiting substrate availability.~   "
62775|NCT02745197|"~     This study evaluates a nutritional supplement in the treatment of pancreatic cancer in~     adults. Half of the participants will receive the nutritional supplement, while the other~     half will receive a placebo.~   "
62776|NCT02745184|"~     Idiopathic pulmonary fibrosis (IPF) is a chronic and ultimately fatal disease characterized~     by a progressive damage of lung structure and decline in lung function.This study intends to~     carry out an open, single-center, non-randomized, self control phase I clinical trial. During~     the treatment, lung stem cells will be isolated from patients' own bronchi and expanded in~     vitro. Cultured cells will be injected directly into the lesion by fiberoptic bronchoscopy~     after lavage. After twelve-month observation, the investigators will evaluate the safety and~     efficacy of the treatment by measuring the key clinical indicators.~   "
62777|NCT02745171|"~     Introduction: Parkinson's disease (PD) results from dysfunction of the dopaminergic system of~     degenerative and progressive, with changes in the nigrostriatal pathway, and decreased~     concentration of dopamine. Has as clinical signs, symptoms called cardinal engines: resting~     tremor, bradykinesia, rigidity and postural instability. In addition to drug therapy,~     physical therapy is also considered a useful tool for the treatment of motor disorders of the~     disease. The role of physiotherapy aims to stimulate the security and independence of~     patients with PD in carrying out activities and to preserve and improve physical function.~     Some studies have shown the negative effect of the disease on quality of life and functional~     mobility. Few studies have been conducted to evaluate the effects of long-term therapy in PD,~     but many report the beneficial effects of a rehabilitation program in a short period of time.~      Objective: To continually assess the effects after the completion of a physical therapy~     program in patients with Parkinson's disease.~      Methods: Type study randomized double blind clinical trial in Parkinson Pro Program Hospital~     of the Federal University of Pernambuco. Will be recruited subjects with PD, both sexes, in~     stages 1 to 3 on the scale of Hoehn Yahr and score greater than 18 on the Mini-Mental.~     Patients who are recruited will undergo an assessment using the scales of assessment of~     functional mobility, quality of life and motor examination before starting physical therapy~     at the end of treatment and two months after completion of treatment, and the intervals~     assessments of a month.~   "
62778|NCT02745158|"~     The Fibrodysplasia Ossificans Progressiva (FOP) Connection Registry is a global,~     non-interventional, voluntary database that captures demographic and disease data directly~     from FOP patients and their caregivers via a secure, web-based patient portal. A physician~     portal (in development) will allow physicians to enter clinical data about their patients.~     The objectives are to organize the international FOP community for participation in clinical~     trials; to enable FOP patients worldwide to report data in a shared forum; to improve the~     collective understanding of FOP natural history; and to advance the understanding of FOP~     treatment outcomes.~   "
62779|NCT02745145|"~     The purpose of this trial is to compare two doses of abituzumab with placebo and determine~     whether abituzumab is more effective, safer, will be better tolerated and can provoke better~     immune response than placebo in the treatment of patients with SSc-ILD who already receive~     constant doses of mycophenolate.~   "
62780|NCT02745132|"~     The overall aim of this study is to evaluate the prevalence of cognitive impairments and~     brain anomalies in Chronic Hepatitis C infected individuals and to investigate likely changes~     in cognition and brain structure and function after treatment with Direct-acting Antivirals~     (DAAs).~   "
62782|NCT02745106|"~     The study evaluates the technique of non-drug treatment of residual pulmonary hypertension in~     patients with chronic thromboembolic pulmonary hypertension after pulmonary~     thromboendarterectomy.~   "
62787|NCT02745041|"~     -  Haemorrhage in severe trauma is a significant cause of mortality and is potentially the~          most preventable cause of death in trauma patients~        -  Trauma Induced Coagulopathy (TIC) is a complex coagulopathy associated with severe~          trauma~        -  Hypo/dysfibrinogenaemia plays an important role in TIC~        -  Early replacement of fibrinogen may improve outcomes~        -  Fibrinogen replacement is potentially inadequate in standard fixed ratio Major~          Haemorrhage Protocols (MHP) utilising Plasma and/or Cryoprecipitate~        -  The majority of centres utilise cryoprecipitate for additional fibrinogen~          supplementation as part of a MHP~        -  Cryoprecipitate administration is often delayed (between 60 - 120 minutes) in a fixed~          ratio MHP~        -  It is clear early intervention in severe traumatic haemorrhage is associated with~          improved outcomes - CRASH 2 and PROPPR studies~        -  Increasing interest in the use of Fibrinogen Concentrate (FC) in severe bleeding but not~          supported by high level evidence~        -  Benefits of FC - viral inactivation, known dose, easily reconstituted, can be~          administered quickly in high dose and stored at room temperature in the trauma~          resuscitation bay~        -  No previous studies comparing FC and Cryoprecipitate in bleeding trauma patients~        -  Fibrinogen supplementation will be guided by an accepted ROTEM targeted treatment~          algorithm~        -  It will be a pilot, multi-centre randomised controlled trial comparing FC to~          Cryoprecipitate (current standard practise in fibrinogen supplementation)~        -  Hypothesis: Fibrinogen replacement in severe traumatic haemorrhage can be achieved~          quicker with a more predictable dose response using Fibrinogen Concentrate compared to~          Cryoprecipitate~        -  It is imperative that robust and clinically relevant trials are performed to investigate~          fibrinogen supplementation in trauma before widespread adoption makes performing such~          studies unfeasible~   "
62788|NCT02745028|"~     Children with a radionuclide gastric emptying test with abnormal results will undergo a~     second test with the addition of a weight adjusted dose of monosodium glutamate. The purpose~     of the study is to determine if a single dose of monosodium glutamate can shorten the gastric~     emptying time.~   "
62789|NCT02745015|"~     The aim of this study is to investigate the effects of non-surgical periodontal treatment on~     the metabolic control of type2 diabetes patients. Patients with type two diabetes mellitus~     patients and confirmed chronic periodontitis will be selected and randomly assign to two~     groups. The treatment group will receive immediate full-mouth scaling and root planing~     whereas the control group will be scheduled to receive periodontal treatment at the following~     3-month visit. Plaque index, bleeding index, probing pocket depth, recessions and cervical~     attachment loss will be recorded at baseline, at six weeks and at three months. Glycated~     haemoglobin (HbA1c) and C-reactive protein (CRP) will be analysed at baseline and three~     months following enrolment.~   "
62790|NCT02745002|"~     Electromagnetic navigation systems have proved feasible for precise intraoperative guiding~     during videobronchoscopy and endobronchial ultrasound transbronchial needle aspiration~     (EBUS-TBNA), based on maps made of preoperative CT images. PET--CT, PET--MRI and fMRI can~     point out malignant lesions.~      When fused into a research navigation system, functional imaging can add information of~     optimal sampling points in lung cancer staging. Correct image registration is then~     fundamental. This study is a build--on to NCT02493023, assessing the position and image~     registration accuracy and clinical feasibility of a multimodal image guiding system in~     patients referred for lung cancer staging by EBUS--TBNA.~   "
62791|NCT02744989|"~     This project aims to provide the proof of concept for transcranial direct-current stimulation~     (tDCS) in the treatment of resistant/persistent Schizophrenia symptoms. The purpose is to~     investigate the effect of tDCS on symptoms in schizophrenic patients demonstrating a partial~     response to a first frequently prescribed antipsychotic medication. An early optimization of~     the therapeutic strategy must constitute an important factor for prognosis. Hypothesize is~     that tDCS should alleviate symptoms in patients depending on the clinical characteristics. In~     this study, stimulation is an add-on treatment to antipsychotic medication, and will be used~     in a broad variety of patients, i.e. in patients with varied durations of illness, various~     symptoms profiles, and various levels of treatment response. This in turn will allow the~     determination of the extent to which results can be generalized to varied patient~     populations, as well as the extent to which various therapeutic targets (e.g. different~     symptom dimensions, cognitive performance and brain connectivity) may be improved with tDCS.~     Despite interesting preliminary results, our team is unable to describe optimal non-invasive~     brain stimulation (NIBS) response markers.~      This study is a randomized, double blind, controlled, French multicenter study (11 centers).~     The investigators plan to include 138 patients with persistent symptoms in schizophrenia.~     Sixty-nine subjects will receive active tDCS and 69 subjects will receive sham tDCS~     (placebo). Hypothesize is a lasting effect of active tDCS on the schizophrenic symptoms as~     measured by the number of responders, defined as a decrease of at least 25% of symptoms as~     measured by a standardized clinical scale score (PANSS) between baseline and after the~     10-session tDCS regimen.~      Furthermore, the participants believe that an in depth understanding of the cortical effects~     of tDCS could constitute an important step towards improving the technique and developing~     treatment response markers. An analysis of the effects on cortical activity and plasticity~     markers could be an interesting approach.~   "
62792|NCT02744976|"~     Prediabetes is a disorder of glucose metabolism that reflects the natural history of~     progression from normoglycaemia to type 2 diabetes mellitus. Patients with prediabetes have~     impaired glucose regulation caused by insulin resistance (IR). IR in patients undergoing~     percutaneous coronary intervention (PCI) is associated with coronary artery remodeling and~     coronary plaque vulnerability by intravascular ultrasound (IVUS) analysis. In stent~     restenosis after bare metal and drug-eluting stent implantation more frequently is observed~     in patients with high fasting-insulin levels and IR. Although IR has a significant role in~     the progression of atherosclerosis in prediabetic patients, the importance of managing~     prediabetes is often under-appreciated by clinicians. To date, no pharmacological treatment~     has been officially approved for prediabetes. According to American Diabetes Association~     recommendations, metformin is the only drug that could be considered in the treatment of~     prediabetic patients with a high risk of developing diabetes. Metformin is a safe and~     inexpensive glucose lowering drug that attenuates mortality and future cardiovascular events~     in patients with type 2 diabetes as well as the progression of atherosclerosis in~     non-diabetic animal models. This study was designed to analyze coronary plaque~     characteristics by iMAP IVUS in patients with and without prediabetes undergoing PCI and to~     evaluate the impact of metformin treatment on coronary plaque characteristics in prediabetic~     patients at 24 month follow up.~      The study hypothesis is that more pronounced coronary atherosclerosis progression as well as~     in-stent neointimal hyperplasia will be observed in patients with prediabetes. Metformin~     treatment attenuates the progression of atherosclerosis in patients with prediabetes.~   "
62793|NCT02744963|"~     This trial evaluates the effect of providing primary care patients with free and convenient~     access to a set of essential medicines. Half of the participants will receive free and~     convenient access to these essential medicines, while the other half will have usual access~     to medicines.~   "
62805|NCT02744807|"~     This study is to evaluate the prevalence of chronic endometritis (CE) in women with severe~     intrauterine adhesions and compare recurrence of adhesion in women with and without CE.~   "
62806|NCT02744794|"~     A pilot study to evaluate the feasibility of altering skin pigmentation using the Dermal~     Cooling System.~   "
62991|NCT02742389|"~     The purpose of this study is to determine whether an intervention (pre-procedure telephone~     call by the investigators) will reduce anxiety in women undergoing urodynamic testing (UDT)~     compared to usual care. Our hypothesis is that women who receive the intervention will report~     less anxiety immediately before UDT than women who receive usual care.~   "
62794|NCT02744950|"~     Surgical defects on the scalp require closure via various techniques of suture placement. A~     traditional technique requires both dermal (deep) and epidermal (superficial) placement of~     sutures to close the defect; this is referred to as intermediate or complex linear repair.~     However, the scalp is a location with high tension, and thus the closures take an hour or~     longer to perform. A type of suture placement referred to as the pulley stitch requires~     placement of a few stitches along the defect. The pulley stitch can be used in areas of high~     tension to close a large defect. The purpose of this study is to compare the scar results and~     time taken to perform scalp closures via only pulley stitches or via intermediate/complex~     linear repairs.~      To my knowledge, no such study has been performed to compare the two techniques. Such a study~     would be useful in demonstrating comparable scar appearance and reduce the time to perform~     scalp closures.~   "
62795|NCT02744937|"~     Objectives: To determine whether TRUS-guided prostate biopsy performed in patients continuing~     low-dose aspirin (LDA) is associated with a greater incidence, duration, and severity of~     bleeding complications.~      Eligibility: Men over 40-year-old with an elevated serum prostate-speciﬁc antigen level~     and/or abnormal digital rectal examination ﬁndings are candidates for PB.~      Design of trial Prospective Randomized Trial Study treatment: Continuing low-Dose aspirin~     before transrectal prostate biopsy Primary endpoint: The incidence, duration, and severity of~     bleeding complications Statistical analysis and sample size estimation: Fisher's exact test~     or chi-square test will be used to explore the differences between two groups for categorical~     variables, and Student t-test will be used for continuous variables. Under the assumption of~     a difference of 25% of bleeding complications in each group, with α=0.05 and power=0.80, 60~     subject are needed in each arm. Assuming the drop-out rate to be 20%, the targeted recruit~     number is 150 in total.~   "
62796|NCT02744924|"~     To develop and implement a physical activity promotion intervention for older adults with or~     without chronic disease living in an urban environment.~   "
62797|NCT02744911|"~     Telehealth, increasingly recognized in the neurology field as a solution to access issues for~     people with Parkinson's disease, improves access to speech therapy, particularly those living~     in rural areas or with travel barriers. The SpeechVive device, developed by SpeechVive, Inc.,~     is a treatment solution that is easy to use and effective. In an NIH funded study, the~     SpeechVive device improved communication in 90% of individuals with PD by improving volume,~     articulation, and speech rate. The investigators propose to eliminate the one drawback of the~     SpeechVive device, namely that it currently must be programmed by a speech-language~     pathologist for each patient in person. The overall goal of this project is to develop a~     telehealth platform for the SpeechVive device that will enable video conferencing for~     treatment and remote programming of the SpeechVive device for each patient. Once the platform~     has been developed, the investigators will conduct a study to examine effectiveness and the~     patient and caregiver satisfaction with telepractice using the SpeechVive device.~   "
62798|NCT02744898|"~     The purpose of this study is to evaluate the safety of treatment with carboplatin and~     Abraxane in this patient population and determine the nature and degree of toxicities~     following treatment. The single stage open label Phase II feasibility study is designed to~     estimate the proportion of patients who can tolerate the proposed regimen for 6 cycles with~     no more than two dose level reductions.~   "
62799|NCT02744885|"~     The purpose of the research is to determine if participants who take Crave Crush will~     report lower cravings and palatability ratings of candy as compared to subjects who receive~     the placebo. Participants are self-selected university students who pass our table and~     verbally agree to participate in a research study about taste preferences. Data will be~     recorded anonymously.~   "
62800|NCT02744872|"~     Lung transplanted patients experience marked decrease in renal function post transplant~     mainly due to cyclosporine induced renal changes. Calcium channel blockers may improve renal~     function in cyclosporine treated transplant recipients through their effects in avoiding~     cyclosporine-induced renal vasoconstriction and facilitating renal sodium output.~      The aim of this study is to examine if calcium channel blockade administered before lung~     transplantation prevent cyclosporine induced nephropathy.~      The design is an intention to treat randomized double blinded single center study. Patients~     are randomized to two groups, one that received felodipine and one that receives placebo.~      Study population is all patients listed for lung transplantation in Denmark in the study~     period.~      Intervention is tablet felodipine titrated to 10 mg, one daily dose in 12 weeks~      Primary endpoint is change in renal function as measured by glomerular filtration rate using~     chromium-51 labeled ethylenediamine tetraacetic acid (51-Cr-EDTA) in the felodipine treated~     group compared with the placebo group.~   "
62801|NCT02744859|"~     Investigators will run a field study evaluating the impact different labels have on the~     purchasing of sugar sweetened beverages. This field study will take place in a hospital~     cafeteria.~   "
62802|NCT02744846|"~     The objectives of the proposed study are to assess the effects of different types, timing,~     and amount of antibiotic use in the first two years of life with (Specific Aim 1) body mass~     index (BMI) and obesity at ages 5 and 10 years and (Specific Aim 2) growth trajectories to~     age 5 years. In Specific Aim 3, the investigators will address how big the effects of~     antibiotics on obesity are within subgroups of the population, such as different~     racial/ethnic groups and whether the child's mother got antibiotics while she was pregnant.~      The data for this study will come from electronic medical records of about 600,000 children~     from 42 healthcare systems within 10 Clinical Data Research Networks (CDRNs) across the~     United States. The investigators will get information on antibiotic prescribing in the first~     two years of life, then virtually follow these children to ages 5 and 10 years to see what~     their BMIs are, and how many of them are obese by clinical standards (i.e., body mass index~     exceeding the 95th percentile for age and sex).~      In the main analyses, the CDRNs will not send any individual data to a central site. Rather,~     using sophisticated computer programs, the study's coordinating center will send questions~     to the data, thus protecting the privacy of patients' and the healthcare systems' records.~     In some analyses, to check how well this distributed research network approach works, we~     will work with individual records whose identifying information has been stripped off~     (de-identified data).~      In our Secondary Aim, the investigators will employ focus groups of parents and in-depth~     interviews with clinicians to explore how best to put the findings into everyday practice.~      Throughout the study, in addition to employing privacy-protecting approaches to analyzing and~     sharing data, the investigators will adhere to principles of inclusion, patient-centeredness,~     stakeholder engagement, effective governance, and protection of human subjects. At the end of~     the two-year project, the investigators will propose avenues for dissemination of the~     scientific findings and other products.~   "
62803|NCT02744833|"~     This study will evaluate the safety profile of GMI-1271 and its effect on thrombus resolution~     in patients with distal calf vein Deep Venous Thrombosis (DVT).~   "
62992|NCT02742376|"~     This study compares the gait pattern of individuals with weight bearing difficulties walking~     on the floor, a soft surface, or with special shoes (Kyboot).~   "
62807|NCT02744781|"~     This study examined whether there is an association between the presence of lumbar~     intervertebral disc degeneration (LDD) and the size and symmetry of the cross-sectional areas~     (CSAs) of the trunk muscles in combat sports athletes. Participants in this study were~     collegiate combat sports athletes. All intervertebral discs from L1/2 to L5/S1 in all~     athletes were assessed using MRI and a comprehensive grading system of LDD (grades I-V). All~     151 athletes were divided into 2 groups: LDD and non-LDD. CSAs of trunk muscles at the L3/4~     disc level were measured on MRI.~   "
62808|NCT02744768|"~     This study aims at exploring the activity of a frontline approach based on dasatinib plus~     steroids administration as induction treatment, followed by the infusion of Blinatumomab, in~     adult Ph+ ALL.~   "
62809|NCT02744755|"~     Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid~     Arthritis~   "
62810|NCT02744742|"~     Allogeneic hematopoietic stem cell transplantation (allo-HSCT) appears to be an efficient~     tool to cure refractory anemia with excess blasts-1 (RAEB-1), refractory anemia with excess~     blasts-2 (RAEB-2) and acute myeloid leukemia (AML) secondary to myelodysplastic syndrome~     (MDS). At present, the best conditioning regimen for RAEB-1, RAEB-2 and AML secondary to MDS~     undergoing allo-HSCT remains in discussion. In this prospective randomized controlled study,~     the safety and efficacy of G-CSF+ Decitabine + BUCY and BUCY myeloablative conditioning~     regimens in patients with RAEB-1, REAB-2 and AML Secondary to MDS undergoing allo-HSCT are~     evaluated.~   "
62811|NCT02744729|"~     This is an open-label single photon emission computed tomography / computed tomography~     (SPECT/CT) study to investigate the safety and diagnostic performance of~     99mTc-HYNIC-3PEG4-E[c(RGDfK)2) (99mTc-3PRGD2) in esophagus cancer patients. A single dose of~     nearly 11.1 MBq/kg body weight of 99mTc-3PRGD2 ( ≤ 20 µg 3PRGD2) will be intravenously~     injected into the patients in suspicion of esophagus cancer. Visual and semiquantitative~     method will be used to assess the whole-body planar and thoracic SPECT/CT images. Any adverse~     events will be collected from the patients.~   "
62812|NCT02744716|"~     This study aimed To investigate the effects of estrogen in combination with aspirin and~     intrauterine balloon on the uterine endometrial repair and reproductive prognosis in patients~     after surgery for severe intrauterine adhesion .~   "
62813|NCT02744703|"~     Matrix metalloproteinases (MMPs); activated by the application of adhesive systems on dentin~     cause degradation of the collagen proteins and loss of bond strength in adhesive~     restorations. Caffeic acid phenethyl ester (CAPE) showed inhibitory activities on dentinal~     MMPs. It is hypothesised that dentin pretreatment with CAPE, as an MMP inhibitor, would be~     beneficial for the bonding of resin material and tooth substrate over the course of time.~     This study evaluated the effect of 5 % CAPE pretreatment on the microtensile bond strength of~     a nanohybrid resin restoration applied with total-etch or self-etch adhesive systems on 10~     patients (12-18 yrs). Two standard cavities (3 x 3 x 4 mm) prepared on the occlusal surfaces~     of one of the two premolar teeth in each patient were randomly assigned into four treatment~     groups (n=10); 5% CAPE pretreatment and total-etch adhesive (TC), Total-etch adhesive~     (control) (T), 5% CAPE pretreatment and self-etch adhesive (SC), Self-etch adhesive (control)~     (S) followed by restoration and 3 months of intra-oral functioning. After teeth extraction,~     the specimens were stored in distilled water+thymol solution at 4°C to inhibit microbial~     growth and used in one week period. Dentin-composite sticks were obtained from each~     restoration for µTBS tests and scanning electron microscopy (SEM) evaluation. Failure mode~     analysis was performed microscopically. Data were analysed statistically using Repeated~     Measure ANOVA (p < 0.05). Dentin pretreatment with CAPE solution (5%) for 60 seconds~     significantly increased the composite resin restorations' bond strengths to dentin applied~     with either total-etch or self-etch adhesive system. Thus it can be used as an MMP inhibitor~     prior to the the resin restorations. However further long term clinical studies are needed to~     support the use of CAPE pretreatment along with self-etch and total-etch adhesive systems.~   "
62814|NCT02744690|"~     This study is a randomized, double-masked trial to examine the response to trabeculectomy~     surgery. In this study, patients will be randomized to receive MMC via subconjunctival~     injection or topical sponge application.~   "
62815|NCT02744677|"~     The purpose of this study is to evaluate the hypothesis that valve dysfunction of the Edwards~     Lifesciences SAPIEN 3 Transcatheter Heart Valve (THV) System is within the performance goal~     of 25% in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or~     previously implanted valve in the pulmonic position with a clinical indication for~     intervention.~   "
62816|NCT02744664|"~     This trial is to designed to assess the efficacy and safety of Cryotherapy combine with~     Icotinib for Advanced NSCLC Patients harboring EGFR mutation.~   "
62817|NCT02744651|"~     Endodrill is a new instrument for biopsy sampling in the GI-channel. The purpose of this~     study is as follows:~      - Compare EUS-guided Endodrill biopsies with endoscopic ultrasound guided fine needle~     aspiration (EUS-FNA) in terms of ability to establish the correct diagnosis of submucosal~     tumors in the upper GI tract.~   "
62818|NCT02744638|"~     The aim of this study is, to investigate, whether the consumption of a probiotic yoghurt~     containing 4 probiotic strains naturally colonizing the vagina (L. crispatus, L. gasseri, L.~     rhamnosus, L. jensenii) has an influence on the comfort of adult women with BV after and 3~     weeks following a standard antibiotic treatment with metronidazole.~   "
62819|NCT02744625|"~     The aim of the study is to measure cerebral perfusion using MRI in healthy subjects (with and~     without sedation) and in vasopressor-dependent patients~   "
62820|NCT02744612|"~     This phase II trial studies how well ibrutinib and brentuximab vedotin work in treating~     patients with Hodgkin lymphoma that has returned (relapsed) or does not respond to treatment~     (refractory). Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Monoclonal antibodies, such as brentuximab vedotin, may interfere~     with the ability of cancer cells to grow and spread. Giving ibrutinib together with~     brentuximab vedotin may be a better treatment for Hodgkin lymphoma.~   "
62821|NCT02744599|"~     This is a small trial to test feasibility of an idea for a potential device. The~     investigators tested the feasibility of prompting a volunteer to breathe when their breathing~     had slowed down during administration of anesthetic drugs.~   "
62822|NCT02744586|"~     The aim of this study is to determine whether a Strengthening our Vows (SOV) intervention~     will reduce HIV exposures from concurrent partnership (CP) when compared to the control Good~     Health Package Plus (GHPP), in addition to couples' voluntary HIV counseling and testing~     (CVCT), among concordant HIV-negative couples living in Zambia.~   "
62823|NCT02744573|"~     There is a lack of sufficient analgesia monitoring apart from surrogate parameters. The~     analgesia nociception index (ANI) shall be evaluated under general and regional anaesthesia.~   "
63015|NCT02742077|"~     The purpose of this study is to evaluate the safety and performance of the CorPath 200 System~     in the remote delivery and manipulation of guidewires and rapid exchange catheters for use in~     percutaneous vascular interventions.~   "
62824|NCT02744560|"~     Thalassemics can develop liver fibrosis because of iron overload and hepatitis C infection.~     The latter is the main risk factor for liver fibrosis in transfusion dependent thalassemics.~     Excess liver iron is clearly recognized as a co factor for the development of advanced~     fibrosis in patients with hepatitis virus C infection. Magnetic resonance imaging represents~     the most available noninvasive technique to assess the level of iron in the liver.there is~     evidence that suggests Spirulina may help to protect against liver damage, cirrhosis and~     liver failure in those with chronic liver disease.~   "
62825|NCT02744547|"~     Thalassemics can develop liver fibrosis because of iron overload and hepatitis C infection.~     The latter is the main risk factor for liver fibrosis in transfusion dependent thalassemics.~     Excess liver iron is clearly recognized as a co factor for the development of advanced~     fibrosis in patients with hepatitis virus C infection. Hyaluronic acid serum levels correlate~     with histological stages of liver fibrosis in hepatitis C patients, so it has a good~     diagnostic accuracy as a non invasive assessment of fibrosis and cirrhosis.there is evidence~     that suggests Spirulina may help to protect against liver damage, cirrhosis and liver failure~     in those with chronic liver disease.~   "
62826|NCT02744534|"~     The purpose of this study is to see if using Positron Emission Tomography (PET) scan and~     transrectal ultrasound (TRUS) guided biopsy together (creating a 3-dimensional ultrasound)~     will detect prostate cancer more accurately than the standard 2-dimensional approach which~     uses only the TRUS to guide the biopsy.~   "
62827|NCT02744521|"~     Introduction: Finding and successfully treating all tuberculosis (TB) patients is the~     cornerstone of the Global Strategy to Stop TB. However, many patients in resource-limited~     countries remain undiagnosed. Prisons are a well-known source of undetected TB. Thus, there~     is a need to find feasible interventions to find and treat TB patients in these settings.~      Objective: The objective of this study is to evaluate whether empowering and involving inmate~     peer educators in TB control has an impact on increasing TB case detection rate and improving~     treatment success in resource-limited prison settings.~      Methodology: This is a matched cluster randomized control trial where randomization to the~     intervention and treatment groups will be carried out within pairs. Eight matched prison~     pairs will be randomly selected for this study in which eight prisons from each pair will be~     randomly assigned to the intervention and the remaining to the control group. Trained prison~     peer educators at the intervention sites will organize and provide education about TB every~     two weeks on a regular basis for one year. Peer educators will also perform routine TB~     screening, using a screening protocol to identify presumptive TB cases for a referral.~     Identified presumptive TB cases will then be linked to the prison health personnel for a~     referral to nearby hospitals. The TB diagnosis will be carried out at the referral sites~     using the routine direct smear microscopy and/or chest X-ray (Radiography). Tuberculosis case~     finding in the control sites will follow the existing referral system (self-referral to~     nearby hospitals) and the diagnosis will be undertaken using direct sputum microscopy and/or~     chest X-ray as in the intervention sites. The data will be entered using Epi Data entry~     version 3.1 software and analyzed using SPSS version 20.0. Considering prisons as a unit of~     analysis, the mean Case Detection Rate (CDR), Treatment Success Rate (TSR) and the percentage~     of patients symptomatic for > =3 months will be compared within pairs using the paired t-test~     or sign test as appropriate.~   "
62828|NCT02744508|"~     Postoperative nausea and vomiting (PONV) is related with extended hospital day and risk~     factor of aspiration pneumonia. Postoperative patient controlled intravenous analgesia is~     related with postoperative nausea and vomiting. Selective 5-HT3 antagonist, Palonosetron, is~     the most recent medication for prevention of PONV. Purpose of our study is comparison of PONV~     preventive effect of palonosetron and combination of palonosetron and dexamethasone.~   "
62829|NCT02744495|"~     To investigate the role of postoperative nausea and vomiting risk factors assessment after~     cardiac surgery. We designed a randomized controlled study comparing standard care (no risk~     factor assessment and no intervention) with prophylaxis of postoperative nausea and vomiting~     after cardiac surgery in high risk patients. Prophylaxis of postoperative nausea and vomiting~     by betamethasone (4mg) and/or droperidol (0.625mg) immediately after cardiac surgery,~     depending on risk factors (if risk score is over 2) in the intervention arm.~   "
62830|NCT02744482|"~     This is an experimental study, prospective, comparative. This clinical trial is randomized~     and double-blind, Residronate versus placebo.~      The study aims to demonstrate the effectiveness of risedronate in pain management, after 18~     month of traitment, in patients undergoing aseptic joint prosthesis loosening. 2 groups were~     compared with a 1: 1 ratio. The first group receives active drug (risedronate 75mg) and the~     second a placebo.~      Patients are treated during 18 months: 1 tablet residronate/placebo per os two consecutive~     days each month.~      Evaluations are planned evry 6 months.~   "
62831|NCT02744469|"~     Tuberculosis is a public health problem caused by a microbe. This microbe may differ from one~     patient to another. The purpose of this study is to know to which extent, each of these~     various microbes is involved in tuberculosis disease in Benin. This study will also find out~     whether the type that affects a patient, depends on patient characteristics and whether the~     difference affects the outcome of the treatment. Finally the study will also help to find out~     whether diagnostic tests are reliable for all types of the microbe. This information will be~     used after the study to inform decision making in order to improve tuberculosis control.~   "
62832|NCT02744456|"~     Many patients want to know which blood pressure medication is the best for them. In this~     study, we will test the feasibility of a new approach to determining the best blood pressure~     medication for individual patients by performing an N-of-1 trial in which patients will have~     the opportunity to test a series of 3 blood pressure medications at escalating doses while~     carefully measuring their blood pressure and side-effects. At the end of each of these N-of-1~     trials, we will ask patients to complete a questionnaire in which they rate their level of~     satisfaction with this approach to learning about which is the best blood pressure medication~     for them.~   "
62833|NCT02744443|"~     Leucine supplementation could be useful to support muscle anabolism. This study aims to~     investigate the effects of leucine supplementation on muscle mass and muscle strength in~     young subjects undergoing resistance training.~   "
62834|NCT02744430|"~     The study will be a prospective randomized double-blind placebo-controlled trial of~     mirabegron for medical expulsive therapy (MET) in patients with a CT (Computed Tomography)~     scan-proven ureteral stone between 4 to 10 mm undergoing expectant management.~   "
62855|NCT02744157|"~     The aim of the present study was to describe a structured intervention to reduce~     cardiovascular risk in a clinical setting and to study the effects of the program on~     lifestyle habits and quality of life in individuals at risk after six months and one year.~   "
62856|NCT02744144|"~     The purpose of the study is to explore the microbiology in war-associated wounds of~     hospitalized patients from the Syrian armed conflict. Cultures collected from acute wounds~     with clinical signs of infection will be analyzed.~   "
62835|NCT02744417|"~     The aim of this prospective interventional study is to verify the efficacy of smoking~     cessation on clinical and microbiological outcomes of non-surgical periodontal therapy of~     chronic periodontitis patients. Smokers willing to quit received periodontal treatment and~     concurrent smoking cessation therapy. Periodontal maintenance was performed every 3 months. A~     single calibrated examiner, blinded to smoking status, assessed periodontal clinical outcomes~     and applied a structured questionnaire in order to collect demographic and behavioural~     information. Further, expired carbon monoxide concentration were measured with a monoximeter.~     A pooled subgingival plaque sample was collected from the deepest periodontal pocket from~     each participant. The presence and quantification of Aggregatibacter actinomycetemcomitans,~     Porphyromonas gingivalis, Tannerella forsythia and Treponema denticola were determined using~     (RT-PCR).~   "
62836|NCT02744404|"~     In Malawi, early infant HIV diagnosis (EID, i.e. HIV screening of infants under 18 months of~     age) is conducted using molecular diagnostics at central laboratories. However, test volumes~     are growing and many parts of the country do not have close or easy access to laboratories.~     Test samples are transported over large distances and this can introduce testing delays,~     especially for patients in rural and remote areas of the country. There are growing numbers~     of high quality Point-Of-Care (POC) diagnostic technologies available and there is increasing~     interest in using these technologies to alleviate critical testing needs. This protocol~     describes an observational study looking at the patient impact of implementing POC EID~     technologies within the routine standard of care at seven facilities.~   "
62837|NCT02744391|"~     This study will elucidate the neurobiology of slowing and LLD, identify a novel therapeutic~     target for depression, and contribute to the development of personalized treatment regimens~     for LLD. The multimodal neuroimaging methods detailed in this application will provide~     information about the neurobiology of aging-associated slowing and LLD at molecular,~     structural, and functional levels of analysis. These data will fill a crucial gap in our~     knowledge regarding what are the physiologic and functional consequences of dopamine~     depletion occurring across the lifespan in individuals without PD. Results from this project~     also will allow us to evaluate a novel therapeutic approach to LLD, which could have large~     public health ramifications given the prevalence, frequent treatment resistance, and~     chronicity characteristic of LLD. Even apart from patients with LLD, cognitive and motor~     slowing exact a large public health burden in terms of impaired functioning and increased~     morbidity and mortality, and this burden will only grow as the population ages. It is~     critical to develop treatments capable of altering the negative health trajectories~     associated with slowing in order to help older adults maintain independent functioning and~     live longer with an increased quality of life. Finally, while PET and MRI may prove critical~     to understand the neurobiology of slowing and LLD, their invasiveness and expense limit their~     roles in informing treatment decisions in clinical practice settings. For this reason the~     investigators are also assessing the influence of genetic moderators such as interleukin-6~     (IL-6) and catechol-O-methyl-transferase (COMT) genotype on baseline dopamine functioning and~     response to L-DOPA. This may facilitate the identification of both high-risk individuals and~     those most likely to benefit from treatment interventions.~   "
62838|NCT02744378|"~     This clinical study is carried out to assess the efficacy of Tacrolimus and Clobetasol in~     symptomatic Oral Lichen Planus.~   "
62839|NCT02744365|"~     The Biobank includes data and biological specimens of women from three original studies: 1)~     First-trimester Prediction of Preeclampsia (PREDICTION Study, NCT02189148), 2) Pre-Eclampsia~     And growth Retardation, an evaluative Longitudinal study (PEARL Study, NCT02379832), 3)~     Effect of Low Dose Aspirin on Birthweight in Twins: The GAP Trial (NCT02280031) and~     4)PREDICTION2: Prediction of Preeclampsia and other Pregnancy Complications Following~     Combined Iterative Screening.~   "
62840|NCT02744352|"~     The purpose of this study is to compare infraclavicular brachial plexus shot single shot~     block to continuous catheter nerve block done in adult patients who have under gone surgery~     to repair distal radius fractures. Visual analogue scores, opioid consumption, quality of~     recovery and quality of sleep up to 72 hours post operatively will be used for comparison.~   "
62841|NCT02744339|"~     The primary objective of this study is to~      • Assess the pharmacodynamic profile of riociguat in subjects with symptomatic pulmonary~     hypertension and heart failure with preserved ejection fraction~      The secondary objectives of this study are to~        -  Assess safety and tolerability of riociguat in this study population~        -  Assess changes in dimensions of left and right ventricles and cardiac function~          parameters using cardiac magnetic resonance imaging~   "
62842|NCT02744326|"~     The investigators will conduct a prospective study and a randomized controlled trial (RCT)~     involving children and adolescents presenting with a primary mental health (MH) concern to~     the emergency departments (EDs) of Children's Hospitals and Clinics of Minnesota (CH). The~     investigators will characterize the primary MH concerns of 800 patients and assess their~     baseline access to and utilization of external resources. All enrolled patients will be~     followed 3-months after their initial visit to determine ED revisits and identify factors~     associated with connection to outpatient care. The RCT portion of the study will involve 200~     patients discharged from the ED with a referral to an outpatient MH provider, and will test a~     novel text-message communication method by which parents/caregivers can be encouraged to~     complete follow-up care for their child. The experimental group will receive tailored text~     message reminders regarding follow-up appointments.~      Relevance: Pediatric ED visits for MH issues are increasing, but the current system of~     managing these patients is not optimal. More information is needed to accelerate change and~     to efficiently invest in improving services available to MH patients. Specifically,~     information is needed on which MH populations need to be targeted, and on simple,~     reproducible interventions which improve connection with community resources. The proposed~     study will collect vital information needed to develop programs that improve outcomes and~     reduce ED revisits in pediatric patients visiting the EDs at CH with primary MH concerns, and~     will set the stage for future work focused on improving core and outcomes for MH youth.~   "
62843|NCT02744313|"~     This study will focus on a population of antipsychotic (AP) naïve adolescents and young~     adults and will measure fat accumulation in relation to exposure to atypical antipsychotic~     medications.~   "
72908|NCT02612649|"~     The purpose of the survey is to evaluate the safety and efficacy of Irribow and Irribow OD~     Tablets in post-marketing medical practice and to examine the status of treatment compliance.~   "
62844|NCT02744300|"~     Women with a history of gestational diabetes mellitus (GDM) have an increased risk of~     developing type 2 diabetes later in life. In our 2012 pilot study we created and tested a~     web-based lifestyle intervention program adapted from the NIH sponsored Diabetes Prevention~     Program (DPP), modified specifically for women with a recent history of GDM. This program,~     delivered in the first year postpartum, encouraged weight loss, dietary changes, and physical~     activity. The purpose of the current study, called Balance After Baby Intervention 2~     (BABI-2), is to study a larger group of women with two years of follow-up. We will assess~     whether women assigned to the intervention group lose more weight and decrease their risk~     factors for type 2 diabetes.~      Participants assigned to the BAB lifestyle intervention will receive support from a lifestyle~     coach and gain access to a website with online presentations that contain healthy eating and~     physical activity educational tips.~      Participants assigned to the post-GDM follow-up group will have access to a website~     containing links to information about diabetes prevention.~   "
62845|NCT02744287|"~     In this protocol, patients with non-resectable pancreatic cancer will have autologous T cells~     collected via apheresis and genetically modified using a retrovirus to express the anti-PSCA~     Chimeric Antigen Receptor (CAR). The T cells will be reinfused according to a dose-finding~     schedule after the subject has been identified as having adequate lymphopenia to provide for~     homeostatic expansion of the adoptively transferred, engineered T cell therapeutic product.~   "
62846|NCT02744274|"~     The aim of this pilot study is to investigate the efficacy of acupuncture in prevention of~     chemotherapy induced peripheral neuropathy. The study adapted a single center, randomized,~     assessor- and participant-blinded, controlled, and parallel-design approach to investigate~     whether acupuncture can prevent or postpone the occurrence of peripheral neuropathy and~     improve quality of life.~   "
62847|NCT02744261|"~     The purpose of this study is to (a) adapt existing user sensory perception and experience~     (USPE) items/instruments generated for rectal gel/cream formulations to include USPEs~     specific to suppository forms for rectal and vaginal use; (b) for both male and female~     cohorts: to capture the experience of suppository use in the context of receptive anal~     intercourse (RAI); and (c) for female cohort only: to capture the experience of suppository~     use in the context of vaginal-penile intercourse (VI), and to compare USPEs of suppository~     use in the context of RAI to USPEs of suppository use in the context of vaginal-penile~     intercourse.~   "
62848|NCT02744248|"~     Study Objectives Primary: To determine MTD and dose limiting toxicities (DLTs) of IOP~     magnetic resonance imaging (MRI) contrast agent in healthy subjects.~      Secondary:~        1. To characterize the pharmacokinetic profiles of IOP MRI contrast agent in healthy~          subjects.~        2. To evaluate safety/tolerability profiles of IOP MRI contrast agent in healthy subjects.~        3. To explore efficacy profiles of IOP MRI contrast agent for liver organ in healthy~          subjects.~   "
62849|NCT02744235|"~     The purpose of this study is to compare two popular portable sleep monitoring devices—the~     Fitbit Charge®, Jawbone UP®, and SleepTime smartphone app—to the gold standard~     Polysomnography (PSG). Parameters that will be analyzed include sleep onset latency, sleep~     efficiency, and sleep staging. Specifically, this study will investigate the validity of the~     Jawbone UP®, Fitbit Charge®, and SleepTime app in detecting sleep and wakefulness in~     comparison to conventional Polysomnography (PSG).~   "
62850|NCT02744222|"~     An International Multicenter Double-blind Placebo-controlled Randomized Study to Compare the~     Efficacy, Safety and Tolerability of BCD-054 (JSC BIOCAD, Russia), 180 μg and 240 μg, versus~     Avonex® (Biogen Idec Ltd., UK) in Patients with Relapsing-remitting Multiple Sclerosis~   "
62851|NCT02744209|"~     This study will test whether immune functions in individual cancer patients can be~     characterized in a quantitative manner using new technologies that analyze nucleic acids from~     peripheral blood cells and whether those quantitations can be used to predict the response~     outcomes of patients being treated with Pembrolizumab.~   "
62852|NCT02744196|"~     The mail goal of this study is to establish superiority in efficacy of Acellbia® applied in a~     dose of 600 mg (Day 1 and Day 15) in combination with methotrexate in patients with active RA~     seropositive previously untreated with biological therapy, compared to standard therapy with~     methotrexate.~   "
62853|NCT02744183|"~     In healthy individuals, the body responds to glucose (sugar) ingestion by reducing the amount~     released from the liver. At the same time, skeletal muscles increase the rate at which they~     remove the glucose from the bloodstream, via the actions of the hormone insulin. This ensures~     that blood glucose levels remain in a controlled range. However, in developed countries,~     diseases such as metabolic syndrome and type 2 diabetes are becoming prevalent, due to~     dietary modifications and a reduction in physical activity. As one of the prominent barriers~     to regular physical activity is a lack of time, finding ways to maximize the health benefits~     of exercise is a priority for researchers.~      The investigators want to understand potential differences in the effects of six weeks of~     aerobic training, with the exercise performed either after breakfast or after a prolonged~     fast. Specifically, this research aims to investigate whether there is a difference in the~     change in processes implicated in glucose regulation and secondly, in subsequent eating and~     physical activity behaviors. By investigating these changes this work will explore how~     exercise and nutrition can be optimized to benefit health and weight loss.~   "
62854|NCT02744170|"~     Oxygen supplementation has been proven to be effective in hypoxemic COPD patients by~     increasing oxygenation and reducing dyspnea. In clinical practice there are three common~     oxygen delivery systems used: continuous oxygen flow (CF), demand oxygen delivery with liquid~     oxygen (DDL) and demand oxgen delivery with portable oxygen concentrator (DDC). The CF~     involves considerable wastage of oxygen because oxygen is supplied during in- and exhalation.~     Demand oxygen delivery saves oxygen and results in a comparable oxygen saturation at rest in~     COPD patients. However, it is unknown, if oxygen supplementation via demand oxygen delivery~     is also sufficient during exercise in hypoxemic COPD patients. In addition, it has to be~     considered that the lower weight of demand oxygen delivery system might enable patients for~     higher physical activity level and mobility in daily life.~      The effects of These three oxygen delivery systems shall be investigated by a randomized,~     controlled cross-over Trial. Every patient has to perform an Incremental Shuttle Walk Test~     and three Endurance Shuttle Walk Tests with three different oxygen supplementation (via CF,~     DDL or DDK) in randomized order.~   "
62857|NCT02744131|"~     Objective: To assess effectiveness of ISD (Insulin sensitizing drugs) Vs OCP (Combined E&P~     cyproterone acetate) in improving clinical, hormonal and metabolic features of PCOS(~     polycystic ovary syndrome)women from India.~      Intervention:~      Randomized to receive Metformin 1500 mg / day OR OCP (EE+CA) Life style advice to women with~     BMI ( body mass index) more than 28 , in both groups (PS: progesterone can be added for~     getting withdrawal bleeding for amenorrhoea of more than two months, or for prolonged~     menstrual bleeding. ) Study period: 6 months Clinical evaluation points and tests at~     enrollment and again after 6 month. Clinical: BMI, Waist circumference, Hip circumference,~     Acne score, FG (modified Ferriman Gallwey score ) (after no epilation for last 6 weeks),~     Menstrual History Biochemical: Thyroid function tests, Prolactin,Total Testosterone, Lipid~     Profile, FAsting blood sugar & 75 gm 2 hr Glucose tolerance test (GTT), Sr Insulin, 25-~     hydroxy vitamin D (optional), (Only Radioimmunoassay / Chemiluminescence assays)~      Acronyms: OCP(oral contraceptive pills); PCOS (polycystic ovary syndrome); FBS(fasting blood~     sugar); GTT(glucose tolerance test)~   "
62858|NCT02744118|"~     This study adapts the Public Health Service (PHS) 5As model for use with adolescent marijuana~     users and pilot the intervention to test feasibility and acceptability in pediatric primary~     care settings. The specific aims are as follows:~      Aim 1: Develop a marijuana screening and brief counseling intervention for adolescents based~     on the Public Health Service 5As model and previously developed adolescent smoking cessation~     intervention.~      Hypothesis 1: The 5As model can be adapted for use as a marijuana screening and counseling~     intervention for adolescents.~      Aim 2: Test the feasibility and acceptability of the 5As marijuana screening and brief~     counseling intervention in pediatric primary care practice.~      Hypothesis 2a: Pediatric clinicians will find the 5As intervention feasible and acceptable~     for addressing marijuana use in routine clinical visits with adolescents and their families;~     and~      Hypothesis 2b: Adolescents will find the 5As intervention delivered by their clinicians to be~     acceptable in the context of routine preventive services delivery.~   "
62859|NCT02744105|"~     Thalassemics can develop liver fibrosis because of iron overload and hepatitis C infection.~     The latter is the main risk factor for liver fibrosis in transfusion dependent thalassemics.~     Excess liver iron is clearly recognized as a co factor for the development of advanced~     fibrosis in patients with hepatitis virus C infection. Transient elastography (Fibroscan) is~     a reliable non invasive method for diagnosing as liver fibrosis in thalassemic patients~     regardless of the degree of iron overload. There is evidence that suggests Spirulina may help~     to protect against liver damage, cirrhosis and liver failure in those with chronic liver~     disease.~   "
62860|NCT02744092|"~     The overarching objective of the study is to determine the effectiveness of LMWH/ warfarin~     vs. DOAC anticoagulation for preventing recurrent VTE in cancer patients. The intervention~     strategy is Direct Oral AntiCoagulants (DOAC) therapy with edoxaban, apixaban, rivaroxaban,~     or dabigatran. The comparator is low molecular weight heparin (LMWH) alone or with warfarin.~     The information gained will empower cancer patients and physicians to make more informed~     choices about anticoagulation strategies to manage VTE.~   "
62861|NCT02744079|"~     Women post breast mass biopsy with ER+ cancer will be randomized to two diets--45 of them to~     a ketogenic insulin inhibiting diet, 20 to a low fat diet simulating their existing diet, but~     with added fruits and vegetables. The initial biopsy will be evaluated along with the~     surgical specimen pathology to compare changes in biomarkers, particularly of proliferation~     (Ki-67) and apoptosis (TUNEL).~   "
62862|NCT02744066|"~     Before they are born, babies are protected from hearing very loud noises by their mother's~     bodies. After delivery, they are exposed to many loud noises that are potentially harmful.~     These noises happen in the neonatal intensive care unit (NICU). The purpose of this research~     project is to test the fit and the ease-of-use of a new device that may protect infant's~     hearing in the NICU.~   "
62863|NCT02744053|"~     The goal of this clinical research study is to learn if investigational imaging scans can~     help researchers predict which patients may respond to treatment. The results of these~     investigational scans will be compared to the results of standard digital mammograms (DMs)~     and ultrasound (US).~      The investigational imaging scans being used on this study are:~        -  Tc99m Sestamibi Molecular Breast Imaging (MBI), and~        -  Dynamic Contrast Enhanced Molecular Resonance Imaging (DCE-MRI).~   "
62864|NCT02744040|"~     The overall objective is to determine the influence of timing of ART initiation and alcohol~     consumption on HIV disease course, including detailed analysis of important events occurring~     shortly after HIV acquisition. ART initiation immediately after HIV infection (during Fiebig~     stages I-II) largely results in smaller HIV reservoir and lower HIV-associated systemic~     inflammation, which has been linked to non-AIDS morbidity and mortality. Immediate ART also~     reduces HIV-associated bacterial translocation and may prevent dysbiosis, an alteration of~     the intestinal microbiota that has been linked to increased systemic inflammation. Immediate~     intervention is not, however, generally feasible and more information is required about the~     consequences of starting ART at later time-points, but still early after acquisition. The~     proposed study will be conducted in Lima, Peru, in the cohort of 180 MSM with acute (Ab-, HIV~     RNA+) or recent (≤ 3 months) HIV infection. Alcohol use disorder is present in ~50% of~     HIV-infected MSM in our cohort, which is four times higher than that seen among males in the~     general Peruvian population. Although the role of alcohol use in HIV pathogenesis and disease~     course remains unclear, some studies show a correlation with accelerated disease progression.~     In animal models and clinical studies, both acute and chronic alcohol consumption have been~     linked to bacterial translocation and activation of the innate immune system, which can lead~     to increases in pro-inflammatory cytokines. The effects of alcohol resemble early~     post-infection changes in bacterial translocation and pro-inflammatory cytokines induced by~     HIV and their impact on HIV disease course before and after ART initiation remain unexplored.~      Specific Aim 1: To determine the relative long-term benefits of immediate vs. early vs.~     delayed ART initiation. The investigators will study outcomes after 1.5 and 3.5 years in MSM~     diagnosed with acute or recent HIV infection. The investigators will examine outcomes in 3~     groups based on time of ART initiation: a) immediate: during FI-II (N~30), b) early: during~     FIII-V (N~50) or c) delayed: at 24 weeks after diagnosis (N~80). The investigators anticipate~     that CD4+ T cell counts and peripheral inflammatory markers in the FIII-V group and the~     delayed group will approach those in the immediate treatment group (FI-II) over time; in~     contrast, they expect that those started ART at early or delayed time points will have~     persistent changes in the GI microbiome and in the HIV reservoir.~      Specific Aim 2: To determine the impact of alcohol use on the relative long-term benefits of~     immediate vs. early vs. delayed initiation of ART. The investigators will examine the impact~     of alcohol use on critical events in HIV infection. They hypothesize that dose-dependent~     alcohol-induced changes will compound the negative effects of HIV and lead to greater levels~     of dysbiosis and inflammation, higher early plasma HIV RNA, and greater seeding and~     persistence of HIV DNA in participants with high-level alcohol use. The investigators will~     assess viral load, GI microbiome and metagenomics, pro-inflammatory cytokines, production of~     msRNA and analyze the impact on alcohol use in all subjects prior to ART initiation and among~     ART-adherent participants with persistent viral suppression.~   "
62865|NCT02744027|"~     Lymphatic Anomalies (LA) is characterized by proliferation of lymphatic tissue causing~     deterioration of pulmonary function. Understanding changes in lymphatic anatomy in these~     patients is hindered by the difficulty of imaging the lymphatic system. Dynamic Contrast~     Enhanced MR Lymphangiogram (DCMRL) may be useful in investigating pathological changes in the~     lymphatic system.~   "
62866|NCT02744014|"~     Rationale: Recent investigations suggest that, through certain concentration/meditation~     techniques, it is possible to modulate autonomic activity. The results of a recent randomized~     controlled trial investigating the Wim Hof Method have shown a direct biological effect on~     in-vivo cytokine production and are strongly encouraging the clinical evaluation of the~     technique's efficacy in immune-mediated inflammatory diseases.~      Objective: To investigate whether an add-on mindset & physical therapy program based on the~     Wim Hof Method can safely and efficaciously be applied in patients with active axial~     spondyloarthritis.~      Study design: Prospective open-label randomized controlled trial, safety and efficacy.~      Study population: Twenty-four patients with active axial spondyloarthritis between 18 and 45~     years of age.~      Intervention: A 30-day training program of add-on mindset and physical therapy for axial~     spondyloarthritis, using the methodology as designed and instructed by Wim Hof. It involves~     breathing techniques, training of mindset and concentration, and gradual cold exposure.~      Main study parameters/endpoints: Safety evaluation of the program is the primary aim of the~     study. Secondary endpoint is the modulation of serum CRP levels. Exploratory objectives~     include modulation of clinical disease activity (ASDAS), quality of life (SF-36, EQ-5D),~     depressive symptoms (HADS), and predictive role of generalized and specific outcome~     expectancies (EPQ-N, LOT-R, VAS scales).~   "
62867|NCT02744001|"~     The purpose of this study is to determine how daily diet relates to eating choices.~   "
63211|NCT02739516|"~     The objective of this study was to evaluate the outcome of follicle stimulating hormone (FSH)~     co-administration with human chorionic gonadotrophins trigger for women with unexplained~     infertility (UEI) and assigned for letrozole (LTZ) stimulated intrauterine insemination (IUI)~     cycles .~   "
62868|NCT02743988|"~     In this randomized crossover trial, preterm infants with intermittent hypoxemia and need for~     supplemental oxygen will be randomized to either Sequence of two different oxygen target~     ranges (low: 85-89%; high: 91-95%) for a total duration of 19 hours. Cerebral oxygenation,~     cardiac output, arterial oxygenation and heart rate will be measured continuously. Primary~     outcome is time with arterial oxygen saturation < 80%.~   "
62869|NCT02743975|"~     There is a need for better visualization of resection margins and detection of small tumor~     deposits during surgery for pancreatic cancer. Optical molecular imaging of pancreatic ductal~     adenocarcinoma associated biomarkers is a promising technique to accommodate this need. The~     biomarker Vascular Endothelial Growth Factor (VEGF-A) is overexpressed in pancreatic cancer~     tissue versus normal tissue and has proven to be a valid target for molecular imaging. VEGF-A~     can be targeted by the monoclonal antibody bevacizumab. Monoclonal antibodies can be labeled~     by the near-infrared (NIR) fluorescent dye IRDye800CW (800CW). The investigators hypothesize~     that bevacizumab-800CW accumulates in VEGF expressing cancer, enabling pancreatic cancer~     visualization using a NIR intraoperative camera system. In this pilot intervention study the~     investigators will determine the optimal dosage of bevacizumab-800CW (4,5 10, 25 or 50mg) to~     detect pancreatic cancer tissue intraoperatively.~   "
62870|NCT02743962|"~     Bladder pain syndrome is a condition where pain is experienced when the bladder fills with~     urine and eases briefly when the bladder empties. There can also be a constant need to~     urgently empty the bladder.~      The internal pelvic floor muscles in people with bladder pain syndrome can be tense and~     painful, and relaxing and stretching them may improve symptoms; reducing bladder pain,~     urgency and how often people have to empty their bladder.~      This pelvic floor release is done by specialist physiotherapists.Therapeutic wands, such as~     the TheraWand®, are used routinely throughout the United Kingdom to allow people to relax and~     stretch their pelvic floor themselves. Using a therapeutic wand has been shown to be safe and~     to reduce pelvic pain, improve bladder and bowel symptoms and relax the pelvic floor muscles.~     However, this research was conducted mostly in men with pelvic pain.~      The aim of this study is to find out if using a therapeutic wand at home as well as having a~     specialist physiotherapist massage the pelvic floor gives any added benefit than just having~     the physiotherapy treatment. The investigators hope to find out if the therapeutic wand gives~     women a way of managing their symptoms independently in their own homes.~   "
62871|NCT02743949|"~     The purpose of this study is to determine the effect of vonoprazan compared to esomeprazole~     for preventing heartburn symptoms over a 4-week treatment period in participants who have a~     partial response to treatment with esomeprazole.~   "
62872|NCT02743936|"~     This is a prospective randomized cross over study of healthy volunteers undergoing continuous~     positive airway pressure ventilation via a noninvasive ventilation (NIV) mask with and~     without the addition of nasal cannulas. Mask leak will be measured by the ventilator after 60~     seconds of spontaneous resting ventilation, with each subject serving as his or her own~     control.~   "
62873|NCT02743923|"~     The purpose of this study is to determine whether carboplatin-paclitaxel-bevacizumab results~     in a prolonged progression free survival compared to cisplatin-pemetrexed as first line~     treatment in patients with KRAS mutated non-small cell lung cancer.~   "
62874|NCT02743910|"~     This study is being done to see if it is possible to use blood samples to predict response to~     treatment in breast cancer patients receiving preoperative (or neoadjuvant) therapy. Research~     has shown that most breast cancers release tumor-specific DNA into the blood (that is, DNA~     that is specific to the tumor cells or cancer). This DNA can be detected in blood testing~     known as plasma tumor-DNA or ptDNA. This DNA is separate from that found in the blood and~     tissue samples which serve as the instruction book or genetic code for the cells that~     make-up the human body. The changes in ptDNA before and after treatment, as well as after~     surgery, may also help investigators to understand more about a patient's risk of cancer~     returning and long-term outcomes.~   "
62875|NCT02743897|"~     This study is being conducted to determine safety and effectiveness of transplanting kidneys~     from Hepatitis C-positive donors into Hepatitis C-negative patients on the kidney transplant~     waitlist, who will then be treated with Zepatier after the single kidney transplantation.~   "
62876|NCT02743884|"~     An esophageal heat exchange tube will be inserted in anesthetized surgical patients. Each~     patient will have 30 minutes of cooling (circulating fluid at 7 degrees C) and 30 minutes of~     warming (42 degrees C) with 15-minute recovery break in between. The primary outcome will be~     heat transfer, determined from inflow and outflow temperatures and fluid flow rate for~     cooling and warming modes.~   "
62877|NCT02743871|"~     The purpose of this study is to evaluate safety, tolerability, pharmacokinetics, and~     pharmacodynamics of PF-06817024 in healthy volunteers, in participants with chronic~     rhinosinusitis, with nasal polyps and in participants with moderate-to-severe Atopic~     Dermatitis~   "
62878|NCT02743858|"~     This study is being done to find out how many women develop lymphedema after an axillary~     lymph node dissection. The investigators also want to look for reasons why some women get~     lymphedema and others don't. Specifically, the investigators want to do tests on the breast~     tissue that is removed at the time of surgery to see if they can identify inflammation in the~     breast tissue, which may increase a woman's risk for lymphedema. The investigators will also~     ask the patient to answer questions to see how much their quality of life is affected by~     lymphedema, and whether this study can help women by detecting lymphedema earlier.~   "
62914|NCT02743390|"~     Resistant hypertension (RH) is characterized by high blood pressure (BP) in spite of~     concurrent use of three or more antihypertensive agents of different classes, combined at~     optimal doses. Currently it has been largely discussed the influence of inflammation in RH.~     The BP variation promotes increased expression of pro-inflammatory cytokines, such as tumor~     necrosis factor-alpha, interleukins 1 and 6. It was showed that treatment with TNF-α~     inhibitor improves BP and endothelial function, and reduces arterial stiffness in patients~     with rheumatoid arthritis. Recently, it was demonstrated that TNF-α levels are increased in~     RH subjects compared to normotensives. This study aims to assess whether the acute inhibition~     of TNF-α changes hemodynamic parameters, such as mean BP levels in RH.~   "
63212|NCT02739503|"~     This study set out to investigate whether antenatal ultrasound evaluation of the Fetal Head~     Circumference (FHC) could potentially possess a predictive role in determining women at~     increased risk for operative delivery or cesarean section.~   "
62879|NCT02743845|"~     The Gene Discovery Core at The Manton Center for Orphan Disease Research based at Boston~     Children's Hospital studies families with rare, poorly understood or undiagnosed, but~     suspected genetic conditions. The primary goal of the research is to better understand the~     genes and proteins (gene products) involved in rare diseases. The researchers hope that our~     studies will allow for improved diagnosis and treatment of individuals with rare disease in~     the future. Individuals with any rare/undiagnosed condition are eligible to enroll.~      Enrollment includes:~        -  Providing DNA and tissue samples (when available)~        -  Access to participants' medical records~      Samples are used for genetic analysis (primarily exome and genome sequencing) to identify the~     genetic cause for the individual's illness. Individual research results are returned to~     families through their health care provider after confirmation in a clinical lab. If a cause~     is identified, that can be reported back to the family through their health care provider and~     the study's genetic counselor. When possible, the investigators also collect samples from~     parents and full-siblings as well as any other affected family members.~   "
62880|NCT02743832|"~     The purpose of this study is to determine whether cervical lymph node dissection is~     necessarily performed in the presence of early-stage oral squamous cell carcinoma.~   "
62881|NCT02743819|"~     Phase II study evaluating the benefit of the combination of anti-PD1 (pembrolizumab) and~     anti-CTLA4 (ipilimumab) antibodies in advanced melanoma. The study will determine the~     response rate of the combination and evaluate other clinical parameters such as~     progression-free survival and safety of the combination following anti-PD1/L1 antibody. The~     study will also provide the opportunity to investigate blood or tumor based factors that may~     predict response to anti-PD1 antibody in combination with anti-CTLA4.~   "
62882|NCT02743806|"~     The purpose of this study is to monitor ongoing safety in subjects with ulcerative colitis~     (UC) and Crohn's disease (CD) and to provide access to vedolizumab for qualifying subjects~     who, in the opinion of the investigator, continue to derive benefit from vedolizumab and for~     whom continued treatment with vedolizumab is desired because there is no other comparable~     product available or the subject may be expected to develop worsening of disease if they were~     to modify treatment.~   "
62883|NCT02743793|"~     Antirejection medicines, also known as immunosuppressive drugs, are prescribed to organ~     transplant recipients to prevent their bodies from rejecting the new organ. Some organ~     transplant recipients can stop taking anti-rejection medicines without rejecting their~     transplanted organ (this is called 'tolerance'). The purpose of this study will collect~     samples and data from 'tolerant' liver or kidney transplant recipients in order to find out:~      The purpose of this study is to collect samples and data in order to find out:~        -  How long liver or kidney transplant recipients can remain tolerant;~        -  What happens in the tolerant recipient's body over time; and~        -  If there are patterns in the body that are linked to tolerance.~   "
62884|NCT02743780|"~     The purpose of this study is to determine if the clinical profile of topical-ocular MGV354~     merits further development for the indication of lowering intraocular pressure (IOP).~   "
62885|NCT02743767|"~     The purpose of this study is to determine if five simple adaptations in airway management of~     patients undergoing general anaesthesia can reduce minor and major airway complications.~      After a first detection of causes of airway complications during general anaesthesia~     investigators initiated five different interventions in airway management, which were:~     immediate bag-valve mask ventilation after administering of muscle relaxants, optimized~     preoxygenation, introducing of a preinterventional checklist, increased usage of video~     laryngoscopy and immediate change of provider in case of failed intubation.~      In a second phase of this observational study investigators want to evaluate if these five~     interventions can reduce minor and major airway complications during general anaesthesia.~      Additionally, investigators want to record how many critical incidents (CIRS) occur during~     this observational period and how many of them will be reported by the involved stuff.~   "
62886|NCT02743754|"~     Kidney injury is a serious complication of cardiac surgery that occurs in up to 30% of~     patients and increases the risk of adverse outcomes. Kidney injury initiates when oxygen~     supply to the kidney drops below levels that are needed for normal cellular function, causing~     tissue oxygen deficiency (hypoxia), activation of the inflammatory cascade, and oxidative~     stress. Together, these events further impair tissue oxygenation, culminating in impaired~     kidney function due to cellular injury and death.~      There are no effective therapies for kidney injury after cardiac surgery, but there is~     evidence that recovery is possible if the processes of injury - i.e., impaired oxygen~     delivery, increased inflammatory response, and oxidative stress - are ameliorated soon after~     the onset of injury. Hyperbaric oxygen therapy (HBOT) - which entails the intermittent~     inhalation of 100% oxygen in a hyperbaric chamber at a pressure higher than one absolute~     atmosphere (> 760 mmHg) - has been shown to positively affect all of these processes (i.e.,~     to improve tissue oxygenation, reduce inflammation, and reduce oxidative stress). Thus, we~     hypothesized that HBOT will reduce the severity of kidney injury after cardiac surgery if it~     is initiated soon after onset of injury. This hypothesis has not been tested in humans, but~     is supported by animal studies.~      In this first-in-human, unblinded, controlled pilot trial, 20 adult patients who develop~     severe kidney injury soon after cardiac surgery will be randomized (after obtaining informed~     consent from the patient or surrogate) to standard-of-care or early HBOT. Severe kidney~     injury will be defined as a ≥30% drop in kidney function within 6 hours of surgery (as~     determined by change in creatinine from before surgery to Intensive Care Unit (ICU)~     admission). This degree of injury occurs in ~ 2% of patients and is associated with a 12-fold~     increase in the risk of complete kidney failure (requiring dialysis) or death. Patients will~     be excluded if they have any relative or absolute contraindications to HBOT (e.g., severe~     ventricular dysfunction, ventricular assist device, severe respiratory dysfunction,~     pneumothorax, bronchospasm).~   "
62887|NCT02743741|"~     This is a prospective single arm, multicenter study will evaluate the efficacy and safety of~     Lutetium-177 Octreotate in patients with neuroendocrine tumors who has positive Somatostatin~     receptor identified by 68Ga-DOTATATE. 195 patients will be enrolled totally. Patient who has~     progressed with neuroendocrine tumor will be evaluated by the tumor board first and eligible~     patients will undergo diagnostic Ga 68 PET scan. Patients who showed Somatostatin will~     undergo 4 cycles of Lu-DOTATATE treatment. Dose adjustment for Cycle 2-4 will be made based~     on individualized dosimetry, as well as creatinine clearance and hematological parameters.~     Patients will be evaluated progression free survival at 12 months from last dose. Patients~     who are negative for somatostatin will not receive 68Ga-DOTATATE treatment but will be~     followed until progression and acts as control group.~   "
63016|NCT02742064|"~     The purpose of this study is to determine if a mobile sensing platform can passively and~     objectively detect the presence of clinically significant mood disorder symptomatology and~     symptom progression over time. Meeting this goal will allow for improved risk categorization,~     prediction of relapse, and measurement of disease progression in a lifetime prevalence~     population.~   "
62888|NCT02743728|"~     The incidence of perinatal stroke is relatively common, as high as 1 in 2,300 births, but~     little is known about the resulting changes in the brain that eventually manifest as cerebral~     palsy (CP). More importantly, no therapy has been devised to mitigate these specific~     maladaptive changes leading to hemiplegic CP. However, motor signs that indicate the infant~     is beginning to develop CP often do not become evident for several months after the diagnosis~     of perinatal stroke. This delays therapy. We view the first several months after perinatal~     stroke as a window of opportunity because it is known to be a critical period of~     development. During this period, a well-designed intervention could minimize maladaptive~     changes in the brain. To design such a science-based rehabilitation protocol for young~     infants during this window of opportunity, we must first develop efficient and reliable~     assessments to detect and measure maladaptive cortical reorganization in the brain.~      Therefore, the main purpose of this study is to examine early brain reorganization in 3-12~     months old infants with perinatal stroke using magnetic resonance imaging (MRI) and~     non-invasive transcranial magnetic stimulation (TMS). In addition, the association between~     the brain reorganization and motor outcomes of these infant participants will be identified.~      In this study, the MRI scans will include diffusion tensor imaging (DTI) - an established~     method used to investigate the integrity of pathways in the brain that control limb movement.~     Infants will be scanned during nature sleeping after feeding. The real scanning time will be~     less than 38 minutes. TMS is a painless, non-surgical brain stimulation device which uses~     principles of electromagnetic induction to excite cortical tissue from outside the skull.~     Using TMS as a device to modulate and examine cortical excitability in children with~     hemiparetic CP and in adults has been conducted previously. In this infant study, we will~     assess cortical excitability from the motor cortex of both the ipsilesional and~     contralesional hemispheres under the guidance of a frameless stereotactic neuronavigation~     system. Additionally, the investigators will assess infants' spontaneous movement quality~     using the General Movement Assessment (GMA) procedure. This will allow the investigators to~     examine the relationship between measures of motor pathway integrity and early signs of~     potential motor impairment.~   "
62889|NCT02743715|"~     Neuromodulation techniques for the treatment of Obsessive-Compulsive Disorder (OCD) have~     expanded with the greater understanding of the brain circuits involved in this disorder.~     Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulation technique~     that has been studied as an alternative for strategy for treatment-resistant OCD. The main~     study is a randomized, sham-controlled, double-blinded trial tDCS for OCD patients~     unresponsive to cognitive-behavioral therapy and/or selective serotonin reuptake inhibitors.~     Forty-four patients will be randomized to two groups: active or simulated intervention. The~     intervention consisted of delivering an electric current of 2mA to the cathode, positioned~     bilaterally in the cranial region corresponding to the supplementary motor cortex, and the~     anode positioned in the deltoid (neutral region), during 30-minutes, for four consecutive~     weeks. The primary outcome was the reduction in baseline YBOCS scores before and after of~     tDCS treatment. Secondary outcomes include measures of depressive and anxiety symptoms,~     genetic markers, motor cortical excitability and performance in neurocognitive tests.~   "
62890|NCT02743702|"~     The main objective of this study is to determine whether the Respiratory Physiotherapy allows~     improvement or maintenance of respiratory function in children with Neuromuscular Diseases,~     against respiratory deterioration that occurs in the group of subjects who did not receive~     this treatment. And to determine whether decreasing the number of respiratory infections and~     secondly the need for antibiotics and the number of emergency room visits and hospital~     admissions related to these.~   "
62891|NCT02743689|"~     The aim of the study is to identify the incidence of early postoperative delirium in~     intensive care patients after cardiac surgery and detect possible risk factors associated~     with increased risk for developing delirium after cardiac surgery.~   "
62892|NCT02743676|"~     This is a global, multi-center, observational registry of participants with suspected or~     confirmed infection with avian influenza A H5N1. Data are collected through retrospective~     abstraction, from detailed case reports that may be published and available in the public~     domain, or as incident cases received directly from the treating physician or other medical~     personnel.~   "
62893|NCT02743663|"~     The study will ascertain the ability of preschool lung function tests to distinguish healthy~     children from those with wheeze, and to differentiate phenotypes of wheezy children (high and~     low risk for asthma as defined by API) in order to predict response to therapy, and to~     explore the correlation between preschool lung function test results and symptoms, in order~     to develop objective methods for monitoring asthma.~   "
62894|NCT02743650|"~     The goal of this pilot study is to determine whether oral sodium bicarbonate can raise low~     serum bicarbonate concentration in people without chronic kidney disease (CKD). Participants~     will take sodium bicarbonate for six weeks, followed by a four week washout period.~   "
62895|NCT02743637|"~     This is a Phase 1 dose escalation to assess the safety, tolerability and maximum tolerated~     dose of subcutaneous administered SDX-7320 in patients with advanced refractory or late-stage~     solid tumors.~   "
62896|NCT02743624|"~     The indications for mechanical ventilation (MV) include excessive work of breathing, with or~     without evidence of respiratory muscle fatigue. The setting of the MV is still a challenge~     because it is based on criteria understudied, often subjective and observer-dependent.~     Despite several studies, to our knowledge has never been done before is the precise~     definition of the optimal range of ventilatory support. Novel and recognizable diagnostic~     techniques will be applied. No single parameter of the breathing pattern has good accuracy~     for the adjustment of ventilatory support. Non-invasive measures such as P0.1 and rate of~     muscle relaxation may have good accuracy for the adjustment of ventilatory support.~   "
62897|NCT02743611|"~     This study will evaluate patients with relapsed or refractory Acute Myeloid Leukemia (AML) or~     advanced hypomethylating agent-resistant myelodysplastic syndrome (MDS) who will have~     autologous immune cells, called T cells, collected via apheresis. The T cells will be~     reinfused according to a dose-finding schedule after the patient has been identified as~     having adequate lymphopenia to provide for homeostatic expansion of the adoptively~     transferred, engineered T cell therapeutic product. As a safety measure, these T cells have~     been programmed with a self-destruct switch so that they can be destroyed if they start to~     react against tissues (Graft versus host disease).~   "
62898|NCT02743598|"~     This study will test the effect of liraglutide on cognitive function in HIV-infected~     overweight or obese subjects with type 2 diabetes.~   "
62924|NCT02743260|"~     The objective of the present study is to contribute to establishing in vivo phenotyping~     procedures for organic anionic transporter polypeptide 1B1 (OATP1B1), organic cation~     transporters 1 and 2 (OCT1/2), multidrug and toxic compound extrusion transporters 1 and~     2,kidney splice variant (MATE1/2K), organic anion transporters 1 and 3 (OAT1/3), and~     p-glycoprotein (P-gp) transporters via a cocktail approach. To this end, marker substrates~     for each of the respective transporters are administered as single doses in one period each~     and as a cocktail in one period to 24 healthy volunteers, and phenotyping metrics are derived~     from plasma and urine concentrations.~   "
62899|NCT02743585|"~     Septic shock carries high mortality, which may be exacerbated by inappropriate initial~     therapy. Inappropriate therapy may result from unanticipated antimicrobial resistance.~     Conversely, positive blood cultures may result from contamination, leading to unnecessary~     therapy and procedures and possibly prolonged hospitalization. Clinicians may also resort to~     broad spectrum antimicrobials and be hesitant to de-escalate while awaiting susceptibility~     results.~      The investigators hypothesize that rapid identification of pathogens and antimicrobial~     resistance will ameliorate the above problems and improve time to optimal therapy, avoid~     unnecessary therapy and ultimately improve patient outcomes. While there are a number of~     in-vitro and uncontrolled clinical studies, there is a paucity of well-designed clinical~     trials objectively examining the real-world clinical and health-economic impact of such~     technology. To date only one randomised trial has been performed in the US~     (ClinicalTrials.gov NCT01898208), at a setting with low endemic rates of antimicrobial~     resistance. This is a companion study to NCT01898208. The investigators aim to study the~     clinical impact and cost-effectiveness of a strategy for rapid pathogen and resistance~     detection in a setting with a moderate to high levels of antimicrobial resistance.~   "
62900|NCT02743572|"~     The purpose of this study is to determine whether iron-fortified PN is effective in the~     preventative and treatment of preterm infants. Preterm infants are at risk for anemia~     especially in preterm infants. Anemia effects growing development, clinical prognosis,~     cognition, movement, learning ability and behavioral development.~      As enteral nutrition is not feasible soon after birth in most preterm infants, parenteral~     iron administration is an efficacious method for investigators to select. For most preterm~     infants, the use of parenteral nutrition(PN) is very common during the first ten days of~     life, so the investigators hypothesis that iron-fortified PN may have a preventative and~     treatment effect on preterm infants using PN as a supplementation of oral nutrition;~     Iron-fortified PN can also improve iron store status of preterm infants. The higher~     concentration of iron used in this study, the larger preventative or treatment effect on~     preterm infants anemia; it is safe to add small dose of iron agent to PN.~   "
62901|NCT02743559|"~     Fractures in children are common and the incidence is increasing. They are more common in~     children who have small, narrow and weak bones. Studies have shown that fractures in early~     childhood are associated with later bone strength.~      There are several (i) non-modifiable (age, gender, race, genetics) and (ii) modifiable~     factors such as nutrition (vitamin D & calcium intake) and exercise that can contribute to~     bone strength.~      Low calcium is associated with an increased risk of fracture. Vitamin D plays a pivotal role~     in bone health by increasing the absorption of calcium from the gut. Investigators know from~     the previous research that there is a reduction in bone strength in children whose mothers~     had lower vitamin D levels during pregnancy.~      Bone growth can also be achieved by loading of bone during childhood in the form of regular~     sport activities such as gymnastics and exercise programmes. Equally it can be achieved by~     using whole body vibration (WBV). WBV is the application of vibratory stimulus to the body in~     a synchronous fashion by which the bones are made much stronger reducing the risk of fracture~     in later life. Thus WBV can be used as a means to assess bone responsiveness to mechanical~     stimulation. Studies have shown that standing on a vibrating platform for 10 minutes a day~     can significantly increase the bone mass. Investigators' own research has also shown that~     healthy boys when made to stand on a vibration platform for 10 minutes daily for 5 days~     increased the strength and quality of their bones.~      Thus the role of diet and mechanical loading are of considerable interest in determining~     their role in bone health and the prevention of fractures.~      Maternal Vitamin D Osteoporosis Study (MAVIDOS) is a large study conducted recently at 3~     different big centres (Sheffield, Southampton and Oxford). Results from this study have shown~     that giving a higher dose of vitamin D to pregnant women every day from 14 weeks of pregnancy~     increased the strength of the bones in their infants. In the proposed study Investigators aim~     to show how vitamin D supplementation during pregnancy affects the response of bone to~     vibration in children whose mothers participated in the MAVIDOS study in Sheffield. These~     children will be 4 years of age when they participate in this study.~      The results of this study will help inform public health policy on vitamin D intake during~     pregnancy. This will also help the investigators identify a possible risk factor for poor~     bone health in children.~   "
62902|NCT02743546|"~     The purpose of this study is to determine whether duvortuxizumab and ibrutinib can be~     combined safely and to establish the maximum tolerated dose (MTD) in Part 1 and the~     recommended Phase 2 dose (RP2D) and to further explore the safety of duvortuxizumab in~     combination with ibrutinib at the RP2D in participants with diffuse large B-cell lymphoma~     (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), and chronic lymphocytic~     leukemia (CLL) in Part 2.~   "
62903|NCT02743533|"~     The Silesian Cardiovascular Database is an observational study of all patients hospitalized~     due to cardiovascular diseases. The date include information on the clinical characteristics,~     treatment modalities and prognosis in this population.~      The data include information on all the applicable diagnostic and therapeutic procedures,~     prognosis and hospitalization costs. Likewise, data have been collected specialist care~     outpatient visits and primary health care patients were hospitalized.~   "
62904|NCT02743520|"~     The purpose of this research study is to learn about arrhythmia detection in obstructive~     sleep apnea (OSA). For several years patients with OSA have an increased likelihood of having~     irregular heartbeats. This study will determine how often patients with OSA have irregular~     heartbeats. This study will also define which OSA patients are most likely to have irregular~     heartbeats.~      The participant is being asked to be in the study because the participant has been diagnosed~     with obstructive sleep apnea (OSA).~   "
62905|NCT02743507|"~     Bundled payment is a new payment reform that encourages health care providers to improve~     quality and contain costs of care. These arrangements are being rapidly expanded across the~     country, but evidence about their impact are lacking. This study will use Medicare claims~     data to evaluate the effect of participation in a large Medicare bundled payment program on~     the quality and costs of care for common medical and surgical conditions.~   "
62906|NCT02743494|"~     The purpose of this study is to determine whether Nivolumab will improve overall survival,~     disease-free survival, or both compared with placebo.~   "
62925|NCT02743247|"~     Coadministration of tacrolimus and mycophenolate mofetil is frequent in kidney~     transplantation. Due to narrow therapeutic range of tacrolimus and mycophenolate mofetil,~     therapeutic drug monitoring with dose adjustment is required. Investigating pharmacokinetic~     interplay between two drugs enables fine dose adjustment, while mechanism of drug interaction~     between two drugs is still not well understood. Therefore, an open-label, three period,~     single dose trial is planned to investigate the drug interaction between tacrolimus and~     mycophenolate mofetil.~   "
62926|NCT02743234|"~     Randomized open label clinical trial to compare the clinical and microbiological efficacy of~     fecal microbiota transplantation, fidaxomicin, and vancomycin for relapsing Clostridium~     difficile infection~   "
62927|NCT02743221|"~     The main purpose of this study is to evaluate the progression-free survival (PFS) in patients~     receiving S 95005 + bevacizumab (experimental arm) or capecitabine + bevacizumab (control~     arm) as first-line treatment for unresectable metastatic colorectal cancer in patients~     non-eligible for intensive therapy.~   "
62907|NCT02743481|"~     Background:~      The Agricultural Health Study (AHS) studied farmers and their spouses in North Carolina and~     Iowa. It also included people who worked with pesticides in Iowa. They answered a~     questionnaire and gave data about their children born since 1975. Researchers want to link~     this data to public data like birth and death certificates. They want to study how early life~     exposures to farms are linked to cancer and other bad health outcomes.~      Objective:~      To study data to find links between early life farm exposure and negative health outcomes.~      Eligibility:~      There will be no human subjects.~      Design:~      Researchers will get public data in the two study states. This will come from things like:~      Birth certificates~      Driver s licenses~      Voter registration~      Death certificates~      Based on these plus the AHS data, they will create a study group. It will be called Early~     Life Exposure in Agriculture (ELEA).~      Researchers will link ELEA data to cancer data. This will identify prevalence of cancer.~      They will study parents answers on the AHS. The topics include farm practices and pesticide~     use. They will determine ELEA exposure to pesticides.~      Researchers will analyze the cancer and pesticide results and look for links.~   "
62908|NCT02743468|"~     Background:~      Respiratory diseases affect more than 1 billion people worldwide. They are a growing public~     health concern. The lungs are constantly exposed to environmental factors such as dust,~     fumes, microbes, and pollutants. But much is still not known about how these pollutants lead~     to respiratory illnesses. Researchers want to collect samples from lungs and blood to see how~     genetics and environmental pollutants affect cellular responses or functioning.~      Objectives:~      To study how cytochrome P450 epoxygenase pathway enzymes affect macrophage function in the~     lungs and inflammatory responses.~      Eligibility:~      Adults ages 18 60 who can have a bronchoscopy.~      Design:~      All study visits will take place at the NIEHS Clinical Research Unit in Research Triangle~     Park, NC.~      At study visit 1, participants will be screened with medical history and physical exam. They~     will have blood and urine tests. They will take tests that measure their lung function. They~     will answer questionnaires. Before the visit, they will be given a list of medicines they~     cannot take. They also must not have caffeine on the day of their visit. The visit will last~     about 3 hours.~      At study visit 2, participants will give blood samples. They will undergo bronchoscopy. For~     this, they will get an intravenous line in a vein to get sedatives. Their airways will be~     numbed. Cells will be collected from their lungs. They will fast for 8 hours before the~     visit. They must have someone else drive them home from the visit. The visit will last about~     3-4 hours.~      Participants will get a follow-up phone call about 1 day after study visit 2.~   "
62909|NCT02743455|"~     This study is a multi-center, double-blind, placebo-controlled, Phase I study to evaluate the~     safety, reactogenicity, tolerability, and immunogenicity of MVA-BN-YF in Flavivirus-naïve~     healthy male and non-pregnant female adult subjects. There are six dose groups in this study.~     Subjects who have never received a licensed or investigational smallpox vaccine will be~     randomized to Groups 1-5 and vaccine administration and follow-up will be conducted in a~     double-blinded fashion. Subjects who have previously received two, 1 x 108 TCID50 doses of~     MVA-BN between 19 and 45 days apart by SC or IM routes will be enrolled in Group 6 and will~     be dosed open-label. Since this is a first in human, phase I study, a sentinel cohort will be~     utilized. The first two subjects (1st sentinel group) one at each clinical site will be~     randomized to Group 2 or 3 and vaccinated with MVA-BN-YF with or without ISA 720. Subjects~     and study personnel will be blinded as to whether ISA 720 was administered.~   "
62910|NCT02743442|"~     Over the past 30 years, endoscopic transnasal techniques have gained a major interest, and~     anatomic limits have been widened in order to extend neurosurgical applications. For many~     years, robotic-assisted surgery using the da Vinci system (Intuitive Surgical Inc, Sunnyvale,~     California, USA) has been greatly developed, especially in urology and gynecology.~      Robotic-assisted surgery has been performed for pharyngeal and laryngeal cancers in a~     minimally invasive perspective.~      A robot-assisted preliminary series demonstrated the ability to approach the sella via oral~     approach without traumatic injury of nasal or oral cavity. Transoral approach avoids the~     complications of the endonasal resection: synechia, rhinitis sicca anterior, primary and~     secondary atrophican rhinitis, and empty nose syndrome.~      The investigators recently published a cadaveric study of transoral robotic-assisted skull~     base surgery to approach the sella turcica (Neurosurgical Rev. 2014; 37:609-17).~      In this study, the investigators will propose a new minimally invasive technique of pituitary~     surgery by transoral approach assisted by the da Vinci robot in patients with pituitary~     adenoma.~   "
62911|NCT02743429|"~     In this trial, monoclonal anti-Disialoganglioside GD2 (GD2) antibody ch14.18/CHO will be~     assessed for the treatment of patients with relapsed or refractory neuroblastoma. The~     antibody is used as a single agent applied in a new treatment schedule associated with less~     side effects.~   "
62912|NCT02743416|"~     The STROKESTOP II study is a proposed study to determine if the biomarker NT-proBNP together~     with single-lead ECG can be used as a primary population screening tool for silent atrial~     fibrillation, and builds on previous results from the STROKESTOP study.~   "
62913|NCT02743403|"~     The project aims to compare the use of carboxiterapia ( therapeutic administration of carbon~     dioxide) with the use of active TENS and placebo TENS using the VAS scale as a parameter. The~     therapy used was started in the 30s , with carbonated water baths, and , lately, is involved~     in the therapeutic arsenal of numerous diseases , Both for treatment of diseases when for~     aesthetic treatments , especially for the gynoid lipodystrophy. However, the therapy presents~     CO2 in clinical practice, limiting factors for its use , such as pain at the injection site ,~     small bruises or welts due to several punctures and feeling of crepitus. To try to combat~     these  side effects  that can last up to 30 minutes, the TENS was used in order to~     determine whether the use of this electric current helps at improvement of discomfort.~   "
62937|NCT02743091|"~     This study investigates the prevalence and prognosis of idiopathic pre-capillary pulmonary~     hypertension (PH) in patients with end-stage kidney disease (ESKD).~   "
62938|NCT02743078|"~     This phase II trial will investigate the efficacy and safety of the addition of Optune (Tumor~     Treating Fields or TTF Therapy) to bevacizumab for patients with bevacizumab-refractory~     recurrent glioblastoma.~   "
62939|NCT02743065|"~     The purpose of this multicenter registry is to gather the safety, efficacy and survival data~     in advanced HCC patients treated with HepaSphere in China in order to evaluate the~     application of HepaSphere deTACE in treating advanced HCC patients~   "
62915|NCT02743377|"~     Background:~      McCune-Albright Syndrome (MAS) is a disorder that affects the bones, skin, and some~     hormone-producing tissues. It is associated with a mutation in a gene. This gene affects~     enzymes in the brain and body. Researchers want to learn more about one of these enzymes,~     Phosphodiesterase 4 (PDE4), in people with MAS.~      Objective:~      To see if people with MAS have higher levels of PDE4 than people without MAS.~      Eligibility:~      People ages 18 and older who have MAS and participated in protocol 98-D-0145, Screening and~     Natural History of Patients with Polyostotic Fibrous Dysplasia and the McCune-Albright~     Syndrome. Healthy adult volunteers are also needed.~      Design:~      This study requires 1 to 4 outpatient visits to the NIH Clinical Center. Some visits may take~     place on the same day.~      Participants with MAS will be screened with medical history and physical exam. They will have~     blood and urine tests.~      Participants will have a magnetic resonance imaging scan.~      Participants will have a full body positron emission tomography (PET) scan. A small amount of~     a radioactive chemical, [11C](R)-rolipram, will be given through an intravenous tube.~      Participants will have a brain PET scan with [11C](R)-rolipram. For this, a thin plastic tube~     will also be put into an artery at their wrist or elbow crease area.~      For the scans, participants will lie on a bed that slides in and out of a scanner. They may~     wear a plastic mask to hold their head in place. They will have blood drawn.~      Participants with MAS will be interviewed about their thinking and mood. They may complete~     questionnaires about how they feel or think.~   "
62916|NCT02743364|"~     This randomized phase II trial studies how well simvastatin works in reducing pancreatitis~     (the inflammation of the pancreas) in patients with pancreatitis that occurs more than once~     (recurrent), has worsened quickly (acute), or has persisted or progressed over a long period~     of time (chronic). Simvastatin may decrease the inflammation of the pancreas by modulating~     the immune response responsible for inflammation. It is not yet known if simvastatin may be~     an effective treatment for pancreatitis.~   "
62917|NCT02743351|"~     This study is a Phase 1, Non-randomized, Open-label/Phase 2 Randomized, Blinded Study of~     ProTmune (ex vivo programmed mobilized peripheral blood cells) Versus Non-programmed~     mobilized peripheral blood cells for Allogeneic Hematopoietic Cell Transplantation (HCT) in~     Adult Subjects Aged 18 to 70 years with Hematologic Malignancies. A maximum of 70 total~     eligible subjects will be enrolled and treated in the trial at approximately 15-20 centers in~     the US and EU.~   "
62918|NCT02743338|"~     This study includes two consecutive sub-trials.~      Cognitive Behavioral Therapy (CBT) is treatment of choice for Insomnia. One of the most~     important treatment Components in CBT for insomnia (CBT-i) is Sleep Restriction (SR), but~     lately, adverse effects related to SR have been reported. A treatment method with~     similarities to SR is Sleep Compression (SC). SC is not as well studied as SR, but appears to~     have similar effects to SR but without the adverse effects. The first sub-trial thus aims at~     directly comparing SR and SC. The second sub-trial aims at evaluating any additional effects~     of CBT-i components given as an add-on treatment to a randomized selection of half~     participants in each original treatment arm.~   "
62919|NCT02743325|"~     Supraventricular tachycardia ablations of the Conformité Européenne (CE)-certified (since~     2013) CartoUnivuTM module (Biosense Webster, Diamond Bar, USA) allows a seamless combination~     of a fluoro image and Carto® 3 System maps into a single view. This helps to reduce~     fluoroscopy levels and reduce exposure time for physicians, staff and patients to as low as~     reasonably achievable. The UnivuTM technology will be compared in a randomized manner to the~     conventional radiofrequency Ablation.~   "
62920|NCT02743312|"~     The goal of this pilot study is to test the protocol for investigating the longer-term~     effects of torso weighting on physical activity, number of falls, and muscle activation (when~     muscles turn on and off and how intensely) in five volunteers with multiple sclerosis. The~     hypotheses of this study include: torso weighting will (1) increase physical activity, (2)~     decrease the number of falls, and (3) improve the timing and coordination of muscle~     activation during balance perturbations.~   "
62921|NCT02743299|"~     The objective of this study is to determine whether healthcare professionals trained in CPR~     can deliver more effective ventilations during CPR using the Handivent, a novel~     turbine-driven ventilator as compared to bag-valve-mask ventilations, using a manikin model.~     The investigators believe the Handivent will deliver a more accurate respiratory rate and~     tidal volume, with lower intrathoracic pressure during CPR.~   "
62922|NCT02743286|"~     Sedentary behavior, characterized by excess sitting time during waking hours, is detrimental~     to health and increases cardiometabolic disease risk, independent of moderate-to-vigorous~     physical activity. The mechanisms that mediate this are unknown and there are no~     evidence-based methods known for effectively intervening on sedentary behavior. The~     consequences of prolonged sitting time are of particular interest in older adults as~     sedentary behavior and cardiometabolic disease risk both increase with aging and~     moderate-to-vigorous physical activity may not be feasible. This pilot study will assess~     interventions for sedentary older adults designed to interrupt prolonged sitting time.~     Interrupting sitting time through sit-to-stand transitions, and standing and walking breaks~     increases muscle use and blood flow in the lower parts of the body. Thus, the investigators~     believe that frequent sit-to-stand interruptions of sitting time are the most efficacious~     sedentary behavior interventions, compared to simply reducing sitting time or less frequent~     walking breaks, for improving health outcomes and healthy aging. The investigators~     hypothesize that frequency of sit-to-stands during a 5-hour sitting period will result in~     health benefits that can be observed with a simple 2-minute standing interruption, and that~     this will be associated with improvements in metabolism and endothelial function. This pilot,~     10-participant study will 1) generate preliminary data for a revised Program Project Grant~     application to the National Institute of Aging (NIA) that focuses on postmenopausal women,~     the fastest growing aged population with high life-time risk of cardiometabolic risk. This~     pilot study will inform sitting interruption modality design for two projects in the~     investigators' Program Project Grant application: Project 1: Sedentary Behavior Interrupted:~     A randomized crossover treatment trial of acute effects on biomarkers of healthy aging in the~     laboratory (86 participants) and Project 2: Sedentary Behavior Interrupted: A randomized~     trial of 6 month effects on biomarkers of healthy aging and physical functioning in the real~     world (660 participants). The current design of this pilot study is enhanced by and~     responsive to feedback from our initial NIA submission. This pilot study will increase our~     knowledge about how sedentary behavior and sitting interruption interventions influence~     healthy aging in postmenopausal women.~   "
62923|NCT02743273|"~     Clinical definitions of acute kidney injury (AKI) have been based on an increase in serum~     creatinine and a decrease in urine output. However, applying this definition to neonates~     remains challenging because of the normal renal physiologic features that serum creatinine~     levels are expected to increase in the first days after birth, and impaired sodium~     reabsorption and concentrating ability.~      Because of several limitations of early detection of AKI, investigators are focused on~     identifying biomarkers that predict AKI before an increase serum creatinine level.~      Investigators will collect urine from preterm infants before and after administrating~     ibuprofen for closing patent ductus arteriosus. To identify novel biomarkers, investigators~     will analyze urine by proteomics. To verify those biomarkers, investigators will use initial~     urine on the first day of life from preterm infants who diagnosed AKI within 7 days after~     birth without any risk factors for AKI and enrolled institutional bio-repository.~   "
62928|NCT02743208|"~     In recent years, short femoral stems have been introduced. Short stems are designed based on~     traditional stems with good clinical results. The assumed benefit of short stems is that they~     are easier to use in mini-invasive surgery, and that preservation of proximal periprosthetic~     bone stock is better. Preservation of periprosthetic bone in the proximal femur is thought to~     secure long time anchoring of the implant, and reduce the risk of loosening. In addition, a~     good proximal bone stock makes later revision surgery less technically demanding. However,~     the short stem design could compromise the stability of the prosthesis, and there has been~     reported diverging results regarding correct positioning of short stems. This may be due to~     the lack of inherent aiming provided by the tip of the traditional long stems. We want to~     clinically evaluate the stability and bone remodelling pattern of a new short femoral stem~     based on a standard stem with excellent long time results. In addition we will compare the~     two different stems regarding positioning, when using a newly developed guiding broach for~     the short stem, and the standard broach for the long stem. Finally, patient reported clinical~     outcome scores will be evaluated with respect to implant and biomechanical reconstruction.~      The aim of this study is to evaluate whether this specific short femoral stem is stable, safe~     to use, and if it provides the expected beneficial effects on bone remodelling.~   "
62929|NCT02743195|"~     The gastrointestinal (GI) ecosystem is a complex network of bacterial cells, host cells and~     tissues that change with age. Fewer numbers and less diversity of beneficial bacteria and~     greater number and diversity of non-beneficial bacteria occurs with age and conditions~     associated with accelerated aging (i.e. obesity, high fat diet)(1,2). This imbalance of the~     microbiota contributes to increased inflammation of the gastrointestinal lining and changes~     to the integrity of the intestinal cell wall.~      Prebiotics, such as non-digestible carbohydrates, can induce the growth or activity~     microorganisms that contribute to the well-being of the host. Recent studies have shown that~     prebiotic treatment can have beneficial effects on glucose levels, lipid metabolism, and~     inflammatory markers in an obese population(3). The polyphenol blend is rich in anthocyanins,~     which is a unique subgroup of flavonoids that have been demonstrated to impact the microbiome~     and have anti-inflammatory properties(4,5,6,7). This open-label study will assess the~     benefits of a prebiotic and polyphenol blend in healthy obese adults.~   "
62930|NCT02743182|"~     Chronic hepatitis B (CHB) affects more than 350 million people worldwide. The most common~     form in Europe is CHB HBeAg-negative. Antiviral treatment of CHB HBeAg-negative patients~     includes chronic administration of nucleos(t)ide analogues (NUC) or pegylated interferon~     (PegIFN) during 12 months. Typically, PegIFN allows immune control of CHB and antigen s~     (HBsAg) loss in around 4% of patients compared to less than 0,1% using NUC. Recently, it has~     been described that HBsAg quantification (HBsAg-q) is useful to identify patients with high~     probability to lose HBsAg during follow-up. In addition, a proof-of-concept study with nine~     HBeAg-negative patients receiving NUC showed that adding PegIFN (16 weeks) achieved HBsAg~     loss in one patient (11%). The aim of our study is to evaluate the efficacy and safety adding~     PegIFN (48 weeks) in treated HBeAg-negative patients with NUC.~   "
62931|NCT02743169|"~     The investigators hypothesize that spatial analysis of the location data of ambulance calls~     can improve prehospital care provided by Aman Foundation in Karachi, Pakistan by decreasing~     ambulance response times for high acuity patients. In Aim 1, the investigators will develop a~     conceptual framework for prehospital care in low- and middle-income countries (LMICs) to~     anchor this project in Aims 2 and 3. In Aim 2, the investigators will analyze the location of~     calls to identify geographic areas with delayed responses for patients with higher severity~     of illness. As part of their quality assurance/quality improvement practices, Aman Foundation~     routinely collects location data from GPS devices in their ambulances for each call. Based on~     the analyses in Aim 2, in Aim 3 the investigators will position ambulances where there are~     clusters of delayed ambulance calls for high acuity patients to improve response times. This~     period will be compared with a previous, control period and will be analyzed to identify~     possible new clusters.~   "
62932|NCT02743156|"~     Contrast-induced acute kidney injury (CI-AKI) is an important adverse effect of percutaneous~     coronary interventions. Despite various efforts, very few preventive measures have been shown~     effective in reducing its incidence.~      The final volume of contrast media utilized during the procedure is a well- known independent~     factor affecting the occurrence of CI-AKI.~      Intravascular ultrasound (IVUS) has been largely used as an adjunctive diagnostic tool during~     percutaneous coronary intervention (PCI). When fully explored, IVUS provides precise~     information for guiding PCI, thereby reducing the usage of contrast media. Accordingly, the~     recent MOZART study demonstrated that IVUS may lead to a 2-3-fold decrease in the volume of~     contrast media during PCI.~      In the present study, the hypothesize that IVUS guidance, and its consequent reduction in the~     volume of contrast media, will in decrease the risk of CI-AKI after PCI, in comparison to~     standard angiography-guided intervention.~   "
62933|NCT02743143|"~     Patients with schizophrenia have disabling symptoms and cognitive deficits that limit~     motivation, drive, social- and occupational performance, quality of life and self-efficacy.~     Schizophrenia also leads to a high risk of dying from cardiovascular disease. Explanatory~     trials suggest that exercise improves cognitive functioning, symptoms, and quality of life,~     and reduces the risk of cardiovascular disease. However, due to this illness, the~     participation in regular exercise is challenging. In this study it will be tested if patients~     with schizophrenia can participate in long-term exercise therapy, and whether long-term~     supervised exercise therapy is more beneficial than today's usual care.~   "
62934|NCT02743130|"~     Berries have been shown to improve postprandial glucose and insulin responses to sucrose.~     During processing and storage of berry products, sucrose is inverted to glucose and fructose.~     The effects of berries on the glycemic response induced by inverted sugar are not known. The~     purpose of this study is to determine whether berries are effective in lowering the~     postprandial glucose and insulin responses induced by inverted sugar.~   "
62935|NCT02743117|"~     This prospective annual release study is designed to evaluate the safety of 1 new influenza~     virus vaccine strain to be included in FluMist Quadrivalent for the 2016-2017 influenza~     season~   "
62936|NCT02743104|"~     The purpose of this study is to determine whether ketamine or propofol, drugs used for~     procedural sedation during paediatric bronchoscopy, results in higher operator satisfaction~     and better side effect profile.~   "
62940|NCT02743052|"~     Purpose: Cancer associated intravascular coagulopathy is the primary mechanism of~     cancer-related stroke, particularly in those without conventional stroke etiologies.~     Randomized clinical trials have investigated efficacy of vitamin K-dependent oral~     anticoagulant (warfarin), low-molecular-weight heparin (LMWH) and non-vitamin K-dependent~     oral anticoagulant (NOAC) for the prevention of systematic venous thromboembolism. However,~     relatively little is known about the biological changes underlying intravascular coagulopathy~     and mechanisms of anticoagulation therapy in patients with cancer-related stroke. The aim of~     this study is to evaluate to determine the biological markers for intravascular coagulopathy~     causing stroke and for monitoring the effects of anticoagulation therapy, in patients with~     active cancer and stroke.~   "
62941|NCT02743039|"~     The Northwestern University Two-Generation Child and Family Outcomes Study (NU2Gen) of the~     Community Action Project of Tulsa County's (CAP Tulsa's) CareerAdvance® program examines the~     effects of CareerAdvance® on parent and child human capital outcomes (e.g., child academic~     achievement, parent educational advancement and certification, and psychological and family~     functioning), and (2) explore mechanisms that might give rise to program effects (e.g., home~     language environment; coping, balance, and stress; and parent and academic and career~     identity).~   "
62942|NCT02743026|"~     Indigenous youth are disproportionately represented in new HIV infection rates in Canada.~     Limited studies have evaluated longitudinal effects of arts-based approaches to HIV~     prevention with youth. The authors present a rationale and study protocol for an arts-based~     HIV and sexually transmitted infections (STI) prevention intervention with Northern and~     Indigenous youth in the Northwest Territories (NWT), Canada. This is a multi-centre~     non-randomised cohort pilot study using a pre-test/post-test design with a 12-month~     follow-up. The target population is Northern and Indigenous youth in eighteen communities in~     the NWT. The aim is to recruit 150 youth using venue-based sampling at secondary schools.~     Participants will be involved in an arts-based intervention, Fostering Open eXpression among~     Youth (FOXY). Participants will complete a pre-test, post-test survey directly following the~     intervention, and a 12-month follow up.~   "
62943|NCT02743013|"~     This clinical pharmacology study is performed to evaluate the total systemic exposure and the~     lung availability of CHF 5993 DPI and pMDI with and without valved holding chamber, in~     healthy volunteers.~   "
62944|NCT02743000|"~     The proposed study will examine the role of reward and emotion in women with and without a~     history of binge eating. It is important to understand how the brain responds to reward and~     emotion in binge eating in order to identify different pathways toward binge eating and~     provide individualized targets for treatment. This is particularly important in light of the~     fact that for many patients, the current treatments for binge eating are not effective.~   "
62945|NCT02742987|"~     CLOTILDIA is a single-center, prospective, randomized, open label, cross-over study~     evaluating the effects of ticagrelor versus high-dose clopidogrel on endothelial function and~     platelet reactivity in patients with type-2 diabetes mellitus (T2DM) treated with~     percutaneous coronary intervention (PCI).~   "
62946|NCT02742974|"~     The aim of this study is to determine if the incidence of post-operative complications can be~     decreased by the implementation of intra-operative, minimally invasive hemodynamic monitoring~     (MIHM) via FloTrac™ and EV1000™ in trauma patients.~   "
62947|NCT02742961|"~     Pain is common after knee replacement surgery and can impact a variety of patient outcomes.~     Peripheral nerve blocks provide improved pain control and may improve function. However,~     their impact on other outcomes is poorly described. Therefore, this comparative effectiveness~     study will estimate the independent association between nerve blocks and health outcomes~     after knee replacement surgery.~   "
62948|NCT02742948|"~     Objective: To determine the optimal time for intravenous antibiotic prophylaxis~     administration in pregnant women undergoing elective cesarean section to minimize postpartum~     infectious complication for both the mother & neonate.~      Study Design: A randomized comparative study. Setting: The Obstetrics and Gynecology~     department of Kasr El Aini hospital (Cairo University - Egypt) in the period from April 2016~     to September 2016.~      Methodology: Six hundred pregnant women aged from 20 to 40 years old with singleton living~     healthy fetuses undergoing elective lower segment caesarean section (LSCS).They will be~     randomized into three groups: group A in which 200 women will receive IV ceftriaxone (2g) 60~     minutes before skin incision, group B in which 200 women will receive IV ceftriaxone (2g)~     immediately with skin incision & group C in which 200 women will receive IV ceftriaxone (2g)~     immediately after umbilical cord clamping. Outcomes include postoperative maternal & fetal~     infectious morbidity.~   "
62949|NCT02742935|"~     This is an open-label, single center, non-randomized, dose escalation phase I trial to~     evaluate safety and tolerability of SHR-1210 in patients with advanced solid tumors. The~     primary objective is to assess safety and tolerability of SHR-1210 and identify recommended~     phase II doses of SHR-1210 in patients with advanced solid tumors.~   "
62950|NCT02742922|"~     To evaluate the clinical and cost-effectiveness of a culturally adapted therapy (C-MAP) in~     patients with a history of self-harm~   "
62951|NCT02742909|"~     To evaluate the acute effect of recombinant human brain natriuretic peptide(rhBNP) on~     pulmonary hypertension of acute exacerbations of chronic pulmonary disease. rhBNP was~     administered as a continuous infusion for 24 hours , pulmonary artery pressure and other~     hemodynamic parameters were monitored by Swan- Ganz catheter.~   "
62952|NCT02742896|"~     Erectile and Cognitive function by using the questionnaire and assessment form before sinus~     conversion~   "
62953|NCT02742883|"~     Current therapies for diffuse, intrinsic pontine glioma (DIPG) provide very limited benefit~     to the patient. The rationale for the use of Antineoplaston therapy in this protocol study~     derives from experience with subjects from prior Phase 2 studies and Compassionate Exemption~     patients treated with Antineoplaston therapy at the Burzynski Clinic.~      This study is designed to analyze the efficacy and safety of Antineoplaston therapy in five~     separate DIPG patient cohorts, which are defined by age and prior therapy. This is a two~     stage study with 20 patients in each cohort being enrolled in the first stage and an~     additional 20 patients being enrolled in the second stage, if pre-determined efficacy~     endpoints in the first stage are realized.~   "
65406|NCT02710864|"~     The primary objectives of this study were to evaluate the incidence of congenital CMV~     infection in neonates, and assess the concordance of detecting congenital cytomegalovirus~     (CMV) infection in neonatal saliva and urine samples.~   "
62954|NCT02742870|"~     Diffusion-weighted sequences have been routinely performed for years to study the pelvis.~     They have been so far mainly qualitatively interpreted, that is to say as the absence or~     presence of an hypersignal at a high b value. The quantitative analysis involves placing the~     region of interest (ROI) on the apparent diffusion coefficient (ADC) map. The manual~     placement is very operator dependent, and does not reflect the entirety of the studied mass.~      In all fields of Magnetic Resonance Imaging, a multiparametric approach integrating diffusion~     analysis is flourishing. However, the quantitative analysis of the diffusion is still little~     studied for tumor heterogeneity analysis, including in the gynecological sphere.~      The investigators will therefore retrospectively evaluate the apparent diffusion coefficient~     (ADC) histograms, extracted from the diffusion ponderation sequences, of the magnetic imaging~     resonance analysis of adnexal masses and confront the results with the anatomo-pathology~     results, for patients having undergone surgery, and/or with the clinical and imagery~     follow-up results.~      The investigators goal will be to improve the performance of conventional MRI in the analysis~     of adnexal masses.~      The expected benefits of this study are:~        -  a correlation with the histology analysis or the clinical monitoring~        -  an improved prediction of the malignancy of the tumor~        -  an improved magnetic resonance imaging performance for adnexal masses, with better~          surgical therapeutic management~        -  an improved negative predictive value, thereby ultimately limiting unnecessary surgical~          explorations.~   "
62955|NCT02742857|"~     This is the proof of concept study with multi-modality approach (using intra-thecal bioactive~     peptides, stem cells, laser and transcranial IV laser and Median Nerve stimulation as~     adjuvants) in cases of brain death due to traumatic brain injury having diffuse axonal injury~     to document possibility of reversal of brain death (BD).~   "
62956|NCT02742844|"~     The aim of this clinical trial is to investigate the efficacy (by monitoring the wound size~     reduction) and safety (by monitoring occurring adverse events) of the investigational~     medicinal product APZ2 after one single application on chronic venous leg ulcer wounds.~   "
62957|NCT02742831|"~     This is a pilot randomized controlled trial of a behavioral intervention focused on improving~     parenting skills and preventing child neglect in families of children with special health~     care needs. The intervention focuses on problem solving, distress tolerance, and emotional~     regulation skills.~   "
62958|NCT02742818|"~     Prospective randomized trial comparing effectiveness of two different forced-air warming~     blankets in patients undergoing lower extremity angioplasty (LEA) and endovascular abdominal~     aortic aneurysm repair (EVAR).~   "
62959|NCT02742805|"~     The proposed research is intended to determine if supplementation of relatively high dose~     vitamin D in chronic urticaria patients receiving omalizumab will result in continued~     symptomatic control of hives after the discontinuation of omalizumab.~   "
62960|NCT02742792|"~     The objective of the study is to evaluate the impact of strength training on sleep apneas in~     the elderly. Individuals aged between 65 and 80 years and that presenting apnea-hypopnea~     index between 20 and 50 events per hour, measured by out-of-center portable polysomnography,~     will be recruited. Those included will be randomized to two groups: Intervention: consisted~     of 12 weeks, twice a week, of strength training; or control: consisted of lifestyle~     recommendations.~   "
62961|NCT02742779|"~     The purpose of this study is to evaluate the safety and tolerability of single and multiple~     orally ascending doses of GDC-0310 administered in healthy participants as 4 parts including~     Part 1- a single dose (SD) part using a powder-in-capsule (PIC) formulation, Part 2- a~     multiple dose (MD) part using a PIC formulation, Part 3- a SD part using a solution~     formulation, and Part 4- a MD part using a solution formulation. Effects of food on~     pharmacokinetics (PK) will also be explored.~   "
62962|NCT02742766|"~     This study is a phase I, randomized, placebo-controlled, double-blind (sponsor unblind),~     three part study. The primary objective of the study is to characterize the safety, and~     tolerability of GSK3008356 single dose, 14 daily repeat doses in healthy subjects and 28~     daily repeat doses in obese subjects. The study has three parts. Part 1, will be a single and~     multiple-dose, dose-rising study in healthy subjects. Part 2, will be a 14-day, repeat-dose,~     dose-rising study in healthy subjects, and part 3 will be a 28-day, repeat-dose study in~     obese subjects. For Parts 1 and 2, data from prior doses cohorts will be available prior to~     escalation decisions. Data from Parts 1 and 2 will be available prior to initiation of the~     three parallel cohorts in Part 3. A dose escalation meeting will be held to review these data~     and document the decision to proceed as planned or make any alterations in dosing, if~     indicated. Part 1, Part 2 and Part 3 study will have approximately 88, 24 and 30 subjects,~     respectively.~   "
62963|NCT02742753|"~     The goal of this study is to look at the effect of pneumococcal conjugate vaccines (PCV) on~     physician-diagnosed otitis media (OM) and acute otitis media (AOM) incidence in Swedish~     children by collecting and analyzing patient level observational data already available in~     existing regional and national databases.~   "
62964|NCT02742740|"~     The Study Buddy ECA acts as an advisor to patients on chemotherapy regimens, promoting~     protocol adherence and retention, providing anticipatory guidance and answering questions,~     serving as a conduit to capture information about complaints or adverse events, providing a~     venue for communicating about updates. The Study Buddy will use the web-based ECA~     infrastructure developed for use on another project. We will use web browsers on tablets~     provided to study participants to access the Study Buddy, providing anywhere, anytime access~     to its functions. Usability metrics will include session time, satisfaction, and error rates.~   "
62965|NCT02742727|"~     The purpose of this study is to evaluate the safety and effectiveness of CAR-pNK cell~     immunotherapy in patients with CD7 positive relapsed or refractory Leukemia and Lymphoma.~   "
62966|NCT02742714|"~     This clinical study is designed to evaluate the PillCam SBC system performance in 50~     established or suspected inflammatory bowel disease (IBD) patients by visualizing and~     assessing their small and large bowel.~   "
62990|NCT02742402|"~     The aim of the study is to evaluate whether patients with early equivocal appendicitis can be~     observed instead of immediate diagnostic imaging. Half of the patients are randomly assigned~     to observation group, while the other half will undergo diagnostic imaging. The hypothesis is~     that resolving appendicitis is common in these patients. Thus, in observation group there~     will be fewer patients with appendicitis diagnosis and observation reduces the use of~     diagnostic imaging and surgery.~   "
62967|NCT02742701|"~     Diabetes prevalence in palliative care is 10-15%. Most hospice patients are treated with~     insulin. The target glucose level is high in order to decrease the risk of hypoglycemia.~     Glucose level is usually monitored using capillary blood glucose once to three times daily.~      The aim of the research is to simplify this pattern of care in end-of-life patients. It will~     evaluate whether the non invasive measurement of glucose in urine could replace the~     measurement of capillary blood glucose. The first objective will be to assess the performance~     of the measurement of glucosuria using urinary dip stix to predict that the blood glucose~     level is within the target range.~      Due to the high glucose target, hyperglycemia is extremely frequent. However, symptoms of~     hyperglycemia are unfrequently reported. They may be unspecific and/or masked in end-of-life~     patients due to terminal disease and medication. The second objective of the study will be to~     define symptoms of hyperglycemia in these patients.~   "
62968|NCT02742688|"~     The investigators performed a 8-week, randomized, double-blind, placebo-controlled human~     trial to evaluate the efficacy and safety of Pyrus pyrifolia var. culta(Makino) NaKai peel~     extract on decrement of body fat. The investigators measured decrement of body fat parameters~     , including Body Fat Mass, Percent Body Fat, weight and BMI(body mass index), and monitored~     their blood pressure.~   "
62969|NCT02742675|"~     The goal of this clinical research is to learn if treatment with androgen deprivation therapy~     in combination with surgery or radiation therapy can prolong the progression-free survival of~     oligometastatic prostate cancer than androgen deprivation therapy alone. The safety of this~     treatment combination will also be studied.~   "
62970|NCT02742662|"~     The study will evaluate whether a technology-based lifestyle intervention program using~     primarily a smartphone platform is an acceptable and effective way for treating obesity. The~     goal of the program is to achieve weight loss and enhance the health of overweight or obese~     subjects by improving their diet and activity via smartphone applications as compared with~     conventional in-person weight management programs.~   "
62971|NCT02742649|"~     The purpose of this study is to determine if a combination of two drugs (bimatoprost and~     timolol) delivered to the surface of the eye over 10 weeks is better at lowering intraocular~     pressure (IOP) than either of the drugs delivered alone.~   "
62972|NCT02742636|"~     Objective: The aim of this study is to evaluate if direct removal of the urine catheter after~     an laparoscopic hysterectomy (total laparoscopic hysterectomy and laparoscopic supracervical~     hysterectomy) is associated with similar (or better) outcomes compared to delayed catheter~     removal after surgery, which is the current treatment. In addition, we want to investigate~     patient's experience on this subject.~      Study design: Randomized Controlled trial, non-inferiority study.~      Study population: Women older than 18 years old, who are a laparoscopic hysterectomy for~     benign indication or low-grade malignancy.~      Intervention:~        -  Group A (treatment group): the patients in this group will have their catheter directly~          removed in the OR after LH.~        -  Group B (control group): the patients in the control group will have their catheter~          removed according to the regular protocol of the hospital (at least 6 hours in place).~   "
62973|NCT02742623|"~     This study aims to collect patient reported outcomes and assess treatment satisfaction in~     active cancer patients treated with rivaroxaban for VTE (venous thromboembolism).~   "
62974|NCT02742610|"~     This study aims to develop a Mindfulness Smartphone Intervention with Contingency Management~     (MSI-CM) for smoking cessation that can be readily available to depressed smokers receiving~     outpatient psychiatric treatment. This project is expected to result in the development of an~     effective intervention that will produce preliminary data showing increased short-term~     cessation success in depressed smokers receiving outpatient psychiatric treatment. It is~     anticipated that this smoking cessation intervention will have potential for broad reach to~     outpatient psychiatric treatment programs and have a significant overall impact in reducing~     smoking-related morbidity and mortality by enhancing smoking cessation rates in at-risk~     populations.~   "
62975|NCT02742597|"~     The aim of Patient-Centred Innovations for Persons With Multimorbidity (PACE in MM) study is~     to reorient the health care system from a single disease focus to a multimorbidity focus;~     centre on not only disease but also the patient in context; and realign the health care~     system from separate silos to coordinated collaborations in care. PACE in MM will propose~     multifaceted innovations in Chronic Disease Prevention and Management (CDPM) that will be~     grounded in current realities (i.e. Chronic Care Models including Self-Management Programs),~     that are linked to Primary Care (PC) reform efforts. The study will build on this firm~     foundation, will design and test promising innovations and will achieve transformation by~     creating structures to sustain relationships among researchers, decision-makers,~     practitioners, and patients. The Team will conduct inter-jurisdictional comparisons and is~     mainly a Quebec (QC) - Ontario (ON) collaboration with participation from 4 other provinces:~     British Columbia (BC); Manitoba (MB); Nova Scotia (NS); and New Brunswick (NB). The Team's~     objectives are: 1) to identify factors responsible for success or failure of current CDPM~     programs linked to the PC reform, by conducting a realist synthesis of their quantitative and~     qualitative evaluations; 2) to transform consenting CDPM programs identified in Objective 1,~     by aligning them to promising interventions on patient-centred care for multimorbidity~     patients, and to test these new innovations' in at least two jurisdictions and compare among~     jurisdictions; and 3) to foster the scaling-up of innovations informed by Objective 1 and~     tested/proven in Objective 2, and to conduct research on different approaches to scaling-up.~     This registration for Clinical Trials only pertains to Objective 2 of the study.~   "
62976|NCT02742584|"~     This is a multicenter, prospective, randomized comparative study in which patients are~     randomized to one of four different bladder volumes and a Cough Stress Test (CST) is~     performed in both the standing and sitting positions. The goal is to assess the agreement of~     each CST method with both urodynamics diagnosis of Stress Urinary Incontinence (SUI) and the~     24-hour pad test. The primary outcome is to determine what CST method best correlated with~     either test in the diagnosis of SUI.~   "
62977|NCT02742571|"~     Prospective, observational clinical monocentric study in ICU; Relationship between Pronostic~     Inflammatory and Nutritional Index (PINI) (and biomarkers related to PINI) and mortality,~     morbidity and nutrition in ICU~   "
65482|NCT02709876|"~     A single arm, single center trial to evaluate the safety and efficacy of autologous purified~     populations of bone-marrow derived stem cells in patients with Retinitis Pigmentosa (BM-SCs)~     through a 48 month follow up period.~   "
62978|NCT02742558|"~     To evaluate and compare the safety and immunogenicity of the Cholvax with ShancholTM,~     Investigators will conduct a clinical trial study Bangladeshi healthy adults and children.~     Cholvax is locally produced orally administered whole cell inactivated bivalent cholera~     vaccine. Incepta vaccine Limited, a leading pharmaceutical company in Bangladesh is now~     producing the oral cholera vaccine, Cholvax with technological support from International~     Vaccine Institute (IVI). Cholvax meets international Good Manufacturing Practice (GMP)~     standards and WHO production guidelines. Cholvax has the same formulation as ShancholTM in~     terms of strains and formulation. By this transfer of technology, it expected that the~     vaccine will become available for use in public health programs in Bangladesh and in the~     future in other cholera-affected countries in Asia and Africa to control endemic cholera, as~     well as to help control large-scale epidemics and outbreaks.~      Investigators will also evaluate and compare the safety and immunogenicity of 3 Cholvax lots~     (lot-to-lot consistency).~   "
62979|NCT02742545|"~     This study evaluates the efficacy of MayoExpertAdvisor (MEA), a knowledge delivery tool, to~     improve adherence to best practices for patients with hyperlipidemia, atrial fibrillation and~     heart failure. Half of the clinicians will receive MEA, while the other half will not receive~     MEA.~      The investigators hypothesize care teams with access to MEA will act upon recommendations at~     a higher rate than those care teams in the standard of care arm without access to MEA.~   "
62980|NCT02742532|"~     The purpose of this study is to determine whether oxytocin will decrease craving to use~     alcohol and stress reactivity following exposure to laboratory-induced stress among Active~     Duty Service Members with a dual diagnosis of alcohol use disorder and post-traumatic~     anxiety.~   "
62981|NCT02742519|"~     To evaluate the efficacy of ivacaftor treatment, as measured by lung clearance index (LCI),~     in subjects with cystic fibrosis (CF) who have a specified CF transmembrane conductance~     regulator (CFTR) gating mutation~   "
62982|NCT02742506|"~     Exposure to music improves cognitive function in 'healthy' participants and in brain-damaged~     patients. However, it is still difficult to understand what precisely in music causes a~     positive effect : are they emotional components, familiarity or preference which improve~     cognition or is there any specific effect of music? Moreover, it is not yet possible to~     characterize the neural and functional links between the brain systems solicited by music and~     those associated with other cognitive functions enhanced by music.~      Finally, researches on brain-damaged patients have not exploited the potential effect of~     music on the level of alert and perceptual awareness, while this type of stimulation could be~     a valuable tool to improve cognition in patients with a disturbance of consciousness and~     alertness.~      The main objective is to describe the impact of music on the brain's response to~     self-referential or neutral stimuli in brain-damaged patients with persistent consciousness~     disorder after a coma and in healthy participants.~   "
62983|NCT02742493|"~     The present study aims to assess the effectiveness of three different retention schemes used~     to maintain tooth position after orthodontic treatment with fixed orthodontic appliances~     (stability) and to evaluate possible association between retention scheme and gingival~     recessions on the lingual surfaces of the lower anterior teeth seen for up to 5 years~     post-treatment. Moreover the possible association between primary relapse tendency and long~     term occlusal stability will be evaluated.~   "
62984|NCT02742480|"~     SEDMAN study is a prospective multicenter investigator initiated study (IIS). The main idea~     is to look by Genome Wide Association (arrays that determine more than 1 million~     polymorphisms) genetic risk factors associated with response to dabigatran. To conduct the~     study, the goal is to recruit 300 patients with ischemic stroke with cardioembolic etiology~     treated with dabigatran and 200 treated with Acenocoumarol to determine if genetic risk~     factors are associated with the occurrence of any bleeding or vascular event in a year~     follow-up.~   "
62985|NCT02742467|"~     The creole study is a A Multi-centre, multinational, randomised single-blind, parallel group,~     three-armed superiority trial which is aimed at comparing the efficacy of three free~     combinations of two anti-hypertensive agents on 24 hour ambulatory systolic blood pressure~     (ASBP) in black African hypertensive patients.~   "
62986|NCT02742454|"~     The purpose of this study is to determine whether providing ventilatory assistance prior to~     umbilical cord clamping influences the occurrence of intraventricular hemorrhage (IVH) in~     extremely preterm (EPT) infants, compared to standard care of providing ventilatory~     assistance after cord clamping.~   "
62987|NCT02742441|"~     This Phase 3 study (Study 310) has been designed to determine and compare the efficacy and~     safety of 122-0551 Foam and Vehicle Foam applied twice daily for two weeks in subjects with~     plaque psoriasis.~   "
62988|NCT02742428|"~     Patients with significant ascites and advanced ovarian cancer (AOC), undergoing complex,~     cytoreductive surgery are at risk of malnutrition, poor quality of life and the risk of hypo-~     or hypervolemia in a perioperative period. All these factors may cause hemodynamic~     consequences during anesthesia and surgery, and elevate the risk of morbidity and mortality.~      The objective of the study is to evaluate, whether slow ascites evacuation for a few days~     before the surgery for AOC, could 1) influence the hemodynamic consequences of ascites on~     systemic circulation in patients undergoing surgery, 2) improve patient's quality of life and~     3) ability to feed correctly before treatment starts, and thus lower the risk of~     perioperative morbidity.~      Eligible patients are those with significant ascites, diagnosed or suspected for AOC, who are~     scheduled for primary surgery (both upfront cytoreduction or laparoscopic evaluation before~     neoadjuvant chemotherapy), that cannot be performed within next 7 or more days, for any~     reason. Patients will be asked to fill in quality of life questionnaire (QLQ). Clinical data,~     a Subjective Global Assessment (SGA) will be recorded. Patients will be randomized to either~     intervention arm A - insertion of vascular catheter into abdominal cavity and slow,~     systematic, daily ascites evacuation, or to observation arm B - standard of care with just~     observation (acute large volume (>5000ml) paracentesis allowed if needed). Patients in both~     groups will be encouraged to use oral nutritional support. Randomization will be open, 1:1,~     for every eligible, consecutive patient. After 7 days patients will be interviewed, asked to~     fill in QLQ, patient's experience on the treatment survey, a SGA will be recorded. During the~     first hour of the surgery hemodynamic data from anethetic charts will be recorded along with~     other clinical data concerning patient's characteristics, surgery details and 30-day~     postoperative follow-up. A template is provided.~      The hypothesis of the study is that slow, systematic ascites evacuation few days before~     surgery for advanced ovarian cancer can facilitate hemodynamic control of systemic~     circulation of patients undergoing surgery, and improve patients' quality of life, feeding~     ability before treatment starts. Secondary we would expect lower risk of perioperative~     morbidity and mortality.~   "
62989|NCT02742415|"~     Since there is a limited amount of evidence on the feasibility and outcomes on the use of~     hand massage in patients undergoing cancer treatment, the purpose of this study is to~     evaluate the feasibility and outcomes of hand massage therapy in cancer patients undergoing~     chemotherapy, and to measure its influence on their symptoms.~   "
65906|NCT02704351|"~     The purpose of this study is to retrospectively review our preliminary experience during a~     surgical trip to Tuxtla, Mexico, using suggamadex to reverse neuromuscular blockade following~     CPB and cardiac surgery for repair of CHD in infants and children.~   "
62993|NCT02742363|"~     The investigators aim is to explore associations between specific types of cancer therapy,~     age at treatment and the presence of dental abnormalities in adolescence.~      The study will help identify unique dental changes, malformations and or missing teeth that~     appear in adolescence as a secondary complication due to anticancer treatment (chemotherapy~     and or radiotherapy) given in childhood.~      Materials and methods:~        -  Study Group: 200 patients, at least 12 years old, who were treated for Cancer at the age~          of 0-10 years old.~        -  The following data will be collected: Demographic information, Medical Status, Cancer~          therapy, Intraoral examination, Oral soft and hard tissue condition and radiographic~          examination.~   "
62994|NCT02742350|"~     Heart surgery procedures are still widely used worldwide for the treatment of patients with~     heart problems, and rates of complications in the postoperative period related to them remain~     high. In these patients, physical conditioning programs result in improved functional~     capacity, and reducing the heart rate and systolic blood pressure. The inspiratory muscle~     training is also emerging as a valuable strategy in the treatment of cardiac patients. The~     study of the interaction between cardiac rehabilitation and high intensity IMT about these~     changes is not yet understood in this population. The aim of this study is to assess the~     effects of inspiratory muscle training high intensity associated with cardiac rehabilitation~     exercise performance of patients in the postoperative period of CABG surgery.~   "
62995|NCT02742337|"~     • Given the cost and risk associated with biologic disease modifying anti-rheumatic drugs~     (bDMARDs), selection of the optimal medication is imperative. Current attempts to identify~     genetic factors that predict bDMARD response and effectiveness in rheumatoid arthritis~     patients have been inconclusive. Furthermore the presence of epigenetic signatures in~     rheumatoid arthritis patients has not been established. This protocol is the first step to~     identifying the practicality and feasibility of epigenetic testing to aid in diagnosis and/or~     medication selection in rheumatoid arthritis patients. Subsequent research into such~     epigenetic changes may be indicative of bDMARD response and/or safety. If such epigenetic~     signatures (EGS) exist the business need for such tests will thus be supported.~   "
62996|NCT02742324|"~     Phase 1/2, open-label, multi-center, trial, aiming at to identify the most efficacious dose~     combination that also satisfies certain safety requirements. It consists in a dose finding~     study to assess the safety of the combination of different doses of both ruxolitinib and~     peg-IFN alpha-2a, and a secondary randomized evaluation of the optimal doses found in the~     first part of the study to a total maximal number of 42 evaluable patients.~   "
62997|NCT02742311|"~     In this prospective observational trial the effect of the Endoscopic discectomy microinvasive~     therapy should be examined in (approximately 500) adult patients with low back pain.~   "
62998|NCT02742298|"~     Study Objectives:~        1. Determine the correlation between quantitative muscle ultrasound (QMUS), electrical~          impedance myography (EIM) and currently accepted measures of physical function.~        2. Determine the reliability of EIM measures performed in the home through use of a hand~          held device.~        3. Determine if QMUS and EIM can detect pre-clinical changes in Pompe disease.~   "
62999|NCT02742285|"~     Measurement of the concentration of antimalarials in the blood of the general population~     helps estimating the overall drug pressure and is used in efficacy studies. The current~     sampling standard for drug measurement is plasma obtained by venous puncture. The use of a~     Dried Blood Spots (DBS) sampling strategy can make some aspects of field trials conditions~     easier, but concordance with usual venous sampling is not yet established.~      The current work will allow validating the concentrations of lumefantrine measured in the DBS~     samples collected during the field trials and validate the use of DBS for future studies. In~     addition, bearing in mind the substantial deployment of artemether-lumefantrine combinations~     supplies throughout most malaria endemic countries, this study may improve our understanding~     of lumefantrine and artemether distribution in the blood compartments and generate knowledge~     for further developing analytical methods for drug measurement.~      The overall purpose of this study is to validate the dried blood spots as a sampling method~     for the analysis of lumefantrine.~      The primary objective is to assess the concordance between lumefantrine plasma and dried~     blood spots (DBS) concentrations.~      The investigators also aim at describing lumefantrine's distribution in the different blood~     compartments: binding to plasma proteins, total in plasma, inside the red blood cells, total~     in whole blood.~   "
63000|NCT02742272|"~     The purpose of this study is to develop a clinical decision rule for patients seen in the~     pediatric emergency department for possible intracranial pathology. This a prospective study~     evaluating patients presenting with headache and migraine. The study is observational and~     does not impact patient care.~   "
63001|NCT02742259|"~     The Prostate Cancer Assay performance of Celsee Diagnostics circulating tumor cell (CTC)~     analysis system will be validated in patients diagnosed with metastatic prostate cancer. It~     will demonstrate substantial performance equivalency to a CTC Assay predicate device.~   "
63002|NCT02742246|"~     Evaluate the efficacy of CBT4CBT and clinician-delivered CBT relative to standard treatment~     for reducing alcohol use~   "
63003|NCT02742233|"~     To investigate the effect of Dipeptidyl Peptidase 4 Inhibition on wound healing in patients~     with diabetic foot ulcers, the investigators randomly divided the participants into two~     groups: saxagliptin with regular treatment group，placebo with regular treatment group. The~     clinical data are collected at the given time point. This study aimed to observe the~     potential protective effect of DPP4i on diabetic ulcers.~   "
63004|NCT02742220|"~     The aim of this study is to analyze the effects of isometric handgrip training (IHT) on blood~     pressure of hypertensive patients with peripheral arterial disease. Will be recruited 60~     patients which will be randomized into 2 groups (30 per group), IHT and control group (CG).~     IHT group will training isometric contraction for 8 weeks. The GC patients will be encouraged~     to increase the level of physical activity. In the pre and post-intervention, brachial and~     central blood pressure will be measured.~   "
63213|NCT02739490|"~     Introduction: The stability of the pelvis is of great importance in body balance as a whole,~     can be improved by training the pelvic muscles fillet (MLP), which is characterized by low~     intensity isometric synchronous and the deep muscles of the trunk. This study aims to~     determine the effect of a stability program target, with the training of the MLP region on~     pelvic stability.~   "
63005|NCT02742207|"~     Atrial fibrillation is a common arrhythmia which requires electrical cardioversion in many~     patients in order to regain sinus rhythm. In a previous retrospective study a complication of~     acute renal failure was found in 17% of the patients after cardioversion.(The incidence and~     prognosis of renal dysfunction following cardioversion of atrial fibrillation. Helman~     Y,...Gilon D et al:Cardiology 2013;124(3);184-9.) Another complication previously described~     after cardioversion is pulmonary edema.~      In this prospective study the investigators aim to evaluate the risk of acute renal failure~     post cardioversion. In addition the investigators would like to evaluate hemodynamic changes,~     fluid balance and sodium levels in patients post cardioversion as a potential mechanism for~     both acute renal failure and pulmonary edema post cardioversion. In order to assess~     hemodynamic changes the investigators will use a non-invasive FDA approved device called~     NICaS (Non-Invasive Cardiac System). This system calculates cardiac output, cardiac index and~     peripheral vascular resistance in a non-invasive, fast and accurate way.~   "
63006|NCT02742194|"~     Regarding its complex pathogenesis and clinic-epidemiological meaning, different strategies~     are needed for the treatment of obesity. Ginger is the rhizome of a plant with thermogenic~     and anti-inflammatory effects, and may be a promising alternative as add-on strategy in the~     treatment for obesity. The primary objective of the current study is to assess whether~     consumption of ginger as an add-on strategy to restrictive diet is effective to reduce fat~     body percentage, increase basal metabolic rate and improve loss weight.~      The secondary objectives are:~        -  to assess the effect of nutritional intervention in quality of diet and weight loss.~        -  to evaluate the effect of ginger on behavioral symptoms and peripheral biomarkers in~          overweight subjects.~   "
63007|NCT02742181|"~     This will be a prospective randomized control trial with a total of 142 patients. Patients~     who undergo laparoscopic or open colorectal resection, small bowel resection, or ileostomy~     reversal with small bowel resection that subsequently develop postoperative ileus will be~     eligible for enrollment. If they meet inclusion/exclusion criteria, they will be randomized~     at the time of diagnosis of postoperative ileus to receive Entereg as rescue therapy or to~     receive conservative standard care.~      Patients randomized to the Entereg group will be given 12mg of Entereg two times daily from~     the time of randomization until the return of bowel function or 5 days. Both groups will be~     treated with conservative standard care, including bowel rest, reduction in oral diet, and~     placement of nasogastric tube as clinically indicated.~      All patients will follow a standard ERAS pathway after surgery, with early feeding and~     ambulation, along with opioid minimizing measures as is our standard postoperative protocol.~      Primary outcome will be hospital length of stay. Secondary outcomes will include time to~     return of bowel function, 30-day morbidity/mortality, complications, reoperation and~     readmission.~      Total number of patients: 142 Patients in each study group: 71~   "
63008|NCT02742168|"~     This is an open-label SPECT/CT (single photon emission computed tomography / computed~     tomography) study to investigate clinical study of 99mTc-3PRGD2 SPECT/CT in diagnosis and~     efficacy evaluation of breast cancer. Diagnostic group: for patients in suspicion of breast~     cancer. The standard of truth for diagnosis was based on histopathologic findings after~     surgical removal of the tumor or a definite diagnosis from fine needle aspiration biopsy. A~     single dose of nearly 0.3 mCi/kg (milli-Curie/kilogram) body weight of 99mTc-3PRGD2 ( ≤ 20 µg~     3PRGD2) will be intravenously injected into the patients. Visual and semiquantitative method~     will be used to assess the whole-body planar and lesions SPECT/CT images.~      Efficacy evaluation group: for patients firstly diagnose with malignant tumors (breast~     cancer), and prepare to chemotherapy(including neoadjuvant chemotherapy) or radiotherapy. The~     standard of truth for diagnosis was based on histopathologic findings after fine needle~     aspiration biopsy. A single dose of nearly 0.3 mCi/kg body weight of 99mTc-3PRGD2 ( ≤ 20 µg~     3PRGD2) will be intravenously injected into the patients before treatment, the second period,~     sixth period. Visual,semiquantitative method will be used to assess the whole-body planar and~     lesions SPECT/CT images. By comparing with result of the other related imaging, for instance,~     PET/CT (positron emission tomography/computed tomography), CT (computed tomography), MRI~     (magnetic resonance imaging), Doppler Ultrasound, Mammography, etc.~   "
63009|NCT02742155|"~     The objective of this study is to evaluate and explore the effectiveness of Play2Sleep on~     families of infants with infant sleep disturbances.~   "
63010|NCT02742142|"~     This study was a randomized clinical trial lasting for 24 months in two study sites, Hong~     Kong (water fluoridated) and Guangzhou (non-fluoridated area). A total of 534 subjects will~     be recruited from elderly social centers located in different districts in the two study~     sites (260 & 274). Baseline clinical examination was conducted by a single calibrated~     examiner in the social centers using an intra-oral LED light, mouth mirrors and probes.~     Subjects were randomly allocated into two study groups and receive interventions accordingly.~     Follow-up examinations at 6-month intervals were carried out to assess the clinical outcomes,~     i.e. whether new root caries developed and whether the active root caries found at baseline~     become arrested. Results of this study could provide the much needed evidence to guide the~     dental professionals in Hong Kong and China, and possibly worldwide in deciding on the most~     appropriate intervention for the prevention and management of this common dental disease of~     the older adults.~   "
63011|NCT02742129|"~     A randomized, double-blind, placebo-controlled crossover study to assess the effect of~     inorganic nitrite (NO2) on aerobic capacity (peak VO2) after four weeks of dosing.~     Approximately 100 participants will be enrolled in this 2*2 crossover study.~   "
63012|NCT02742116|"~     The objectives are to:~        1. Assess patient's views and preferences in receiving expanded carrier screening~        2. Perform qualitative study on post testing counselling on screen positive individuals and~          at risk couples~   "
63013|NCT02742103|"~     This study is a phase 2, multicenter, double-blind, randomized, placebo controlled,~     parallel-group study to investigate the renal safety and tolerability of multiple dose~     intravenous (IV) administration of CSL112 compared with placebo in subjects with moderate~     renal impairment (RI) and acute myocardial infarction (AMI).~   "
63014|NCT02742090|"~     This is a Phase 2, open-label, study of TGR-1202, a PI3K delta inhibitor, administered as a~     single agent in Chronic Lymphocytic Leukemia (CLL) patients who are intolerant to prior BTK~     inhibitors (ibrutinib, other) or prior PI3K delta inhibitors (idelalisib, other)~   "
63017|NCT02742051|"~     This open, randomized pilot feasibility trial is to evaluate the feasibility and effect of~     neoadjuvant everolimus plus letrozole versus neoadjuvant fluorouracil, epirubicin plus~     cyclophosphamide (FEC) in treating postmenopausal women with ER-positive, HER2-negative~     breast cancer. Forty postmenopausal stage M0, ER-positive, HER2-negative invasive breast~     cancer women who had a primary tumor > 2cm by imaging or an axillary lymph node > 2cm by~     imaging were randomly (1:1) enrolled to receive neoadjuvant everolimus plus letrozole for 18~     weeks or neoadjuvant FEC for 6 cycles before surgery. The primary objective is to determine~     the feasibility of neoadjuvant everolimus plus letrozole in postmenopausal patients with~     ER-positive, HER2-negative breast cancer, and to compare the objective response rate.~     Secondary aims are to compare the response rate by clinical palpation, pathological complete~     response (pCR) rate, breast-conserving surgery rate, toxicities, and changes in the~     percentages of peripheral blood CD8+ T cells, T helper cells (Th), regulatory T cells (Treg),~     and NK cells (pre- versus post- neoadjuvant therapy).~   "
63018|NCT02742038|"~     Triple-blind randomized controlled trial with two parallel arms conducted between 2012 and~     2014. Children 2-3 years old, from 28 rural public preschools, located in low socioeconomic~     areas of Chile were invited to participate. Oral health education component was given to~     children, parents and educators, twice yearly. A new toothbrush and toothpaste for each child~     was delivered to the parents at baseline and in each of the follow-up visits. The~     experimental group was treated with fluoride varnish every six months while the control group~     received placebo applications. 277 preschoolers (2 to 3 years) Main outcome: Number of Caries~     Incident Cases, increment dmft index~   "
63019|NCT02742025|"~     The main objective of this study is to evaluate the impact on preoperative anxiety of an~     education and information program conducted prior to non-urgent coronary angiography~     performed in patients hospitalized at the Nîmes University Hospital.~   "
63020|NCT02742012|"~     The present study is designed to validate an multimodal indicator of anesthetic depth~     (Schneider G et al. 2014, Anesthesiology 120, 819-28).~      The indicator previously developed shall now be tested on an independent set of data.~      The investigators will include 250 patients undergoing general anesthesia in 3 German~     tertiary care centers.~      The design is strictly observational - the anesthetic regime is at the discretion of the~     clinician and will not be influenced.~   "
63021|NCT02741999|"~     This protocol seeks to enroll smoldering multiple myeloma (SMM) and monoclonal gammopathy of~     undetermined significant (MGUS) patients with λ light chain (LC) involvement, a group of~     patients for whom standard of care is observation not treatment. Patients with SMM and MGUS~     have a precursor plasma cell disorder from which light chain amyloidosis (AL) can evolve. In~     this trial, enrolled subjects will have blood and if available bone marrow cells evaluated by~     molecular testing to determine their clonal λ LC variable region (VL) germline gene. Seventy~     percent of AL cases involve just 7 germline donors, 5 of which are λ germline donors. The~     hypothesis that will be tested with this protocol is that the presence of AL germline genes~     associated with AL in patients with a pre-existing diagnosis of λ SMM or λ MGUS indicates the~     presence of AL or risk of progression to AL.~   "
63022|NCT02741986|"~     Brief Summary: The goal of this study is to implement and test an intelligent perioperative~     system (IPS) that in real-time predicts risk for postoperative complications using routine~     clinical data collected in electronic health records. The accuracy of computer-generated risk~     scores will be compared to physician's risk scores for the same patients. Physicians will be~     also asked to provide the opinion regarding the computer-generated risk scores using~     interactive interface with the program. The information regarding the risk scores performance~     will be collected during the two 6-month periods. The accuracy of IPS and physicians will be~     compared at the end at those two time periods.~   "
63023|NCT02741973|"~     The aim of this trial is a first evaluation of the effectiveness of yoga as alternative for~     school sports to evaluate potential effects in stress reduction and concomitant psychological~     parameters.~   "
63024|NCT02741960|"~     This is a multicenter, randomised, double-blind placebo controlled trial on the efficacy and~     safety of add-on metformin to conventional immunosuppressants in systemic lupus erythematosus~     (SLE).~      The purpose of this study is to evaluate: 1) the effect of metformin on reducing disease~     flares; 2) the influence of metformin on corticosteroid sparing effect; 3) the influence of~     metformin on body mass index (BMI); 4) the safety of metformin.~   "
63025|NCT02741947|"~     The trial was an experimental two-centers, randomized, double-blind, two-sequence,~     non-inferiority cross-over study.~      Screened subjects already treated with Levodopa/Benserazide (LDB) (Madopar®) who agreed to~     participate in the study entered a 4 weeks period if not on stable regimen of Madopar®~     (run-in period). Following the run-in period, there were two maintenance periods of 4 weeks~     each, for a total duration of 8 weeks.~      Patients were assigned randomly (1:1) by a computerized randomization system to one of two~     formulation sequences maintaining the dose stabilized during the run in:~        -  generic-originator~        -  originator-generic At the end of maintenance period 1, the patients in each formulation~          group underwent an overnight switch to the same dose of the alternative formulation. The~          dose was kept stable during the whole length of trial. Clinical evaluations were~          performed at the end of each period. The tablets were encapsulated to maintain the~          blindness.~      A pharmacokinetic study with a fixed dose (100+25 mg) was performed in a sub-population of 14~     subjects.~      Population: out-patients with a diagnosis of idiopathic Parkinson's disease for at least 5~     years, receiving L-dopa/benserazide.~      The total duration of the trial was approximately 8 weeks for patient divided in two~     maintenance periods of 4 weeks each.~   "
63026|NCT02741934|"~     This study evaluates the cognitive and behavioral outcomes including image findings of~     school-aged children who were born preterm compared with who were born term gestational age.~   "
63027|NCT02741921|"~     The investigators sought to compare the time to intubation and success rate of the~     endotracheal intubation using standard double-lumen tube and video tube ETView DL in an adult~     cadaver model in normal and difficult airway conditions.~   "
63214|NCT02739477|"~     This study aims to evaluate favipiravir high dose tolerance in male survivor of Ebola Virus~     Disease (EVD) with Ebola Virus (EBOV) RNA in semen. This is a dose escalation study with 3~     cohorts of 6 patients, each dose level including 2 sentinel patients.~   "
63028|NCT02741908|"~     Obesity is a chronic illness and multifactorial etiology, related to genetic factors,~     environmental and behavioral. Features association with several metabolic abnormalities in~     childhood, leading to increased risk of cardiovascular disease in adult life. The treatment~     involves lifestyle change, with balanced diet guidance and encouraging physical activity. The~     treatment in this age group have brought limited data, in addition to high drop-out rates. A~     unique type of food guidance is the equivalent calorie count, where calories are converted~     into points. The objective of this study was to evaluate the variance of Z score of body mass~     index (ZIMC) of obese adolescents undergoing orientation of two groups of low-calorie diet:~     traditional and based on the points system, as well as evaluate anthropometric variables,~     body composition, food intake, metabolic changes and self-monitoring.~      METHODS: randomized clinical study with duration of 24 weeks, with 66 adolescents with an~     average age of 13.7 ± 0.7 years of both genders, with scores of BMI >= 2 to <= 4 curve~     adjusted for gender and age of the World Health Organization. Were verified weight, height,~     blood pressure and waist circumference, intensity of physical activity and self- monitoring,~     as well as performed the nutritional guidance to each visit. Laboratory parameters, applying~     the scale of binge eating, pubertal, stage and body composition were evaluated at the~     beginning and end of the action. The patients were divided into two groups: one that received~     guidance of traditional low-calorie diet and meet the food consumption record (RCA), three~     days (Group A) and another that received low-calorie diet guidance based on the system of~     points and meet the daily RCA (Group B).~   "
63029|NCT02741895|"~     This study will evaluate whether information on postoperative ambulation from Fitbits can~     improve surgeons' ability to monitor ambulation and identify patients at risk for prolonged~     length of stay, 30-day readmissions, and discharge to transitional care after major surgery.~   "
63030|NCT02741882|"~     It is suspected that zika virus infection during pregnancy is associated with microcephaly.~     The objective of this study is to investigate the occurrence of rash accompanied by three or~     more dengue-like signs and symptoms during pregnancy is related to the microcephaly using the~     case-control design.~   "
63031|NCT02741869|"~     The purpose of the study is to evaluate whether PDT (MRSAid™) is effective in eradicating SA~     from hemodialysis patients who are known to harbor this organism inside their nose.~   "
63032|NCT02741856|"~     Research has shown that increasing the dose of radiotherapy improves outcomes in patients~     with lung and head and neck cancers. This study aims to see whether this is also the case for~     patients with tumour of the oesophagus. This trial will compare the effects of the standard~     dose of radiotherapy to a higher dose whilst closely monitoring the side effects.~      A comparison will also be made regarding the effects of the standard drugs used in~     chemotherapy (cisplatin and capecitabine) with an alternative combination (carboplatin and~     paclitaxel) in patients that do not show a response to chemotherapy with standard drugs early~     on in treatment.~      All patients will receive 6 weeks of chemotherapy and 5 weeks of chemoradiotherapy.~      How the study will be conducted:~      Prior to the commencement of treatment each patient will have a special scan called a PET~     scan. Patients will receive a second PET scan two weeks after the start of standard~     chemotherapy. The changes between the two scans will then be used to allocate treatment into~     the different arms of the study. All study subjects will be randomised to receive either the~     standard radiotherapy dose or the high radiotherapy dose. The participants that do not~     respond to the first cycle of standard chemotherapy will be eligible to take part in the~     aspect of the trial looking at an alternative chemotherapy regimen. Patients will be~     randomised as follows;~      On the basis of the second PET scan, patients who are not responding to standard chemotherapy~     will be allocated by a computer to one of the four groups detailed below:~        -  Standard chemotherapy and standard dose of radiotherapy~        -  Standard chemotherapy and higher dose of radiotherapy~        -  Alternative chemotherapy and standard dose of radiotherapy~        -  Alternative chemotherapy and higher dose of radiotherapy~      Patients who are responding to standard chemotherapy (or where the response is unknown or~     those who were not eligible for PET scan portion of the study) will be allocated by a~     computer to one of two groups detailed below:~        -  Standard chemotherapy and standard dose of radiotherapy~        -  Standard chemotherapy and higher dose of radiotherapy~      The arms within each of the groups above (responders and non-responders) will be equal in~     size and patients will be allocated randomly by a computer.~      This study will also compare the way that this treatment affects the two different cell types~     found in oesophageal tumours.~      The effects of the different treatment, together with the costs of the different treatment~     and the effects on quality of life will be analysed to see which is more effective for each~     of the different groups.~   "
63033|NCT02741843|"~     The purpose of this study is to test the effectiveness of brief face-to-face patient~     education in increasing uptake of influenza vaccine among Chinese elderly in the community.~   "
63034|NCT02741830|"~     This cross sectional, two cohort study seeks to investigate both anatomic outcome and~     subjective, functional outcome of uterosacral ligament suspension versus robotic~     sacrocolpopexy and compare patient satisfaction, bladder function, sexual function and~     complication rate for each procedure.This study will provide a better understanding about the~     durability of these procedures and long term complication.~   "
63035|NCT02741817|"~     The study is going to compare two different doses of aspirin for the treatment of heart~     disease in combination with the anticlotting medication ticagrelor. One of these doses of~     aspirin, 75 milligrams (mg) once a day, is the current standard treatment dose of aspirin~     used to treat heart attacks and angina. The other, 20 mg twice a day, is lower than the~     standard but there is growing scientific evidence that, when given with ticagrelor, this~     might offer advantages over the usual dose.~   "
63036|NCT02741804|"~     The purpose of the Lifestyle Intervention Study is to investigate the influence of a~     micronutrient supplement in combination with a comprehensive lifestyle intervention program~     on retinal amyloid, among patients with Mild Cognitive Impairment (MCI). Patients will be~     placed on supplement or placebo throughout their 18-month study participation. Patients will~     also be given lifestyle training on nutrition, physical activity, cognitive and social~     activity, meditation and sleep, which have all been proven to positively affect cognition~     over time. Throughout their participation, patients' cognitive functioning will be monitored~     with comprehensive imaging, neuropsychological testing, blood testing and study compliance.~   "
63037|NCT02741791|"~     To evaluate the efficacy and safety of AXS-05 relative to bupropion in subjects with~     treatment resistant major depressive disorder (MDD).~      This is a randomized, double-blind, active-controlled, 12-week, two-period study consisting~     of an open-label, bupropion lead-in period, and a double-blind treatment period. The trial is~     being conducted in subjects with treatment resistant MDD.~      Subjects will be considered to have treatment resistant MDD if they have had a historical~     inadequate response to 1 or 2 antidepressant treatments and a prospective inadequate response~     to treatment with bupropion during the open-label, lead-in period.~   "
63049|NCT02741622|"~     Acute aerobic exercise improves affective stats in patients with mental illnesses. Brain~     derived neurotropic factor (BDNF) may be a biological mechanism that contributes to the~     affective benefits. The magnitude of the increase of serum BDNF might be exercise intensity~     dependent, but no study has compared low high-aerobic-intensity training at 90-95 % of the~     maximal heart rate (HRmax) with long-slow-distance training at 70 % of the HRmax in patients~     with depression.~      The aim of this study is to compare changes in serum BDNF levels after high-aerobic-intensity~     training and long-slow-distance training in a intra-individual design in patients suffering~     from depression. The results will give indications of a possible difference in BDNF response~     between aerobic intensities and may be uses as pilot data for calculating sample size.~   "
63038|NCT02741778|"~     Of the esophagogastric junction adenocarcinoma (AEG) is a 5 cm region of adenocarcinoma of~     the esophagus and stomach. Due to the special anatomical location, the biological behavior of~     esophageal cancer and gastric cancer are not the same. For the resection of esophageal~     gastric junction adenocarcinoma, the main treatment method for the treatment of surgical~     treatment.~      For the type II type of esophageal gastric junction adenocarcinoma, the mainstream of the~     traditional surgical approach for the left chest to open the chest, for the lesions of the~     small type of esophageal gastric junction adenocarcinoma can be performed minimally invasive~     Ivor-Lewis esophageal resection.~      There is no reasonable standard for treatment of type II type esophageal gastric junction~     adenocarcinoma. The investigators sum up the experience of the past in the minimally invasive~     resection of esophageal cancer, and combine domestic and foreign research results. Pioneered~     by laparoscopic mobilization of the stomach and dissection of the abdominal field lymph node~     + thoracoscopic (left thoracic approach) to free the esophagus and cleaning + mirror under~     the purse string forceps esophagogastric aortic arch anastomosis under lower mediastinal~     lymph node, corresponding to the operation is the traditional through left thoracotomy~     combined with open operation on diaphragm. Can achieve the same with the traditional surgical~     resection of the tumor, while taking into account the characteristics of minimally invasive~     surgery. This study intends to provide a minimally invasive surgical treatment of the chest~     laparoscopy combined with minimally invasive surgery and traditional thoracotomy. Comparison~     of different surgical methods for patients with the safety of surgery, oncology resection~     range, the incidence of short-term complications. The effect of different surgical methods on~     the survival rate and quality of life of the two groups were compared with the postoperative~     follow-up. The surgical treatment of esophageal carcinoma with a reasonable level of type II~     type of esophageal gastric junction adenocarcinoma is improved, and the surgical treatment of~     esophageal gastric junction adenocarcinoma is improved.~   "
63039|NCT02741765|"~     This is a feasibility and exploratory study consisting of two parts: first, a cross-sectional~     (one-time) biomarker measurement comparing BDNF-TrkB (Brain-derived neurotrophic factor~     (BDNF) and its receptor, TrkB,) signaling and cortical plasticity in patients diagnosed with~     Parkinson's Disease (PD) vs. healthy controls matched by age. Second, a prospective,~     randomized, double blind trial of Transcranial Magnetic Stimulation (TMS) MAGSTIM Rapid2~     Therapy System (TMS) (real or Sham) and aerobic exercise. This exploratory feasibility study~     will look at BDNF-TrkB signaling and cortical plasticity.~   "
63040|NCT02741752|"~     The purpose of this randomized clinical trial was to evaluate the effect of cortical bone~     decortication on the angiogenesis and osteogenesis of augmented ridge by GBR.~   "
63041|NCT02741739|"~     Primary Objective: Determine blood concentrations of two formulations of REGN1033.~      Secondary Objective: Assess safety and tolerability of REGN1033.~   "
63042|NCT02741726|"~     The purpose of this study is to compare the effects of dual acupoints and single acupoint~     transcutaneous electrical acupoint stimulation (TEAS) pretreatment on incidence of~     Post-Mastectomy Pain Syndrome(PMPS) in patients undergoing operation of breast cancer.~   "
63043|NCT02741713|"~     The standard practice for arthroscopic shoulder surgery at our institution is a general~     anesthetic with a long-acting interscalene block for post-operative pain control, which can~     reduce the amount of opiates needed after surgery. The interscalene block is effective in~     providing analgesia to the majority of the shoulder joint and has been shown to reduce~     post-operative pain scores after arthroscopic shoulder surgeries. However, there is a subset~     of arthroscopic shoulder surgery patients who have pain in the axilla even in the setting of~     a functioning interscalene brachial plexus nerve block. One of our surgeons has reported a~     high incidence of axillary pain in patients who undergo a sub-pectoral biceps tenodesis as~     part of their arthroscopic procedure. A newly described nerve block approach to the nerves~     that supply sensation to the axillary region called the PECS Pectoralis 1 & 2 block may~     provide additional analgesia to these patients.~      The purpose of this prospective, randomized, observer and patient blinded, single-center,~     sham block trial is to determine if the addition of PECS blocks to an interscalene block will~     reduce the severity of axillary pain following arthroscopic shoulder surgery that involves a~     sub-pectoral biceps tenodesis. Secondarily, the study will assess the duration of PECS 1 & 2~     and whether the block reduces post-operative opioid usage. We hypothesize that the addition~     of the PECS 1 & 2 block will reduce the severity of axillary pain at 6hrs and reduce~     postoperative narcotic usage for the first 24 hours.~   "
63044|NCT02741700|"~     The objective is to test the efficacy of a patient-centered, culturally relevant narrative~     intervention, or storytelling, based on the solid conceptual foundation of the narrative~     communication theory and the constructs of the Health Belief Model (HBM) to improve~     medication adherence and outcomes in chronic diseases among African-Americans (AA), using~     gout as an example. Gout is a chronic disease associated with chronic symptoms and disability~     interrupted by intermittent acute flares, similar to Chronic Obstructive Pulmonary Disease~     (COPD) and Congestive Heart Failure (CHF) that leads to joint destruction if not treated~     appropriately. Due to the intermittently symptomatic nature of chronic conditions, patients~     often don't perceive disease severity and susceptibility to disease complications, and,~     therefore, may not balance the barriers and benefits to medication adherence. Storytelling in~     the patients' own voices has the power to directly and more effectively confront a patient's~     barriers to medication adherence, reinforce the benefits and provide useful cues to action.~     Storytelling promotes patient engagement when the patient identifies with the storyteller and~     can lead to a patient's recognition of the need to treat the condition and improve health~     outcomes, as shown by a meaningful improvement in blood pressure in a recent clinical trial~     in AAs with hypertension. The success of this project, combined with other published data,~     will represent a major step toward demonstrating the effectiveness of storytelling to improve~     medication adherence in chronic diseases and will address two VA research priority areas,~     i.e., health care disparities and health care delivery.~   "
63045|NCT02741687|"~     The purpose of this study is to compare sitagliptin with a placebo for the prevention of high~     glucose after general surgery.~   "
63046|NCT02741674|"~     The main goal of this research project is to conduct a comparative effectiveness research~     study involving existing data in the PCORnet Common Data Model to provide accurate estimates~     of the 1-, 3-, and 5-year benefits and risks of the three most common bariatric procedures -~     Roux-en-y gastric bypass, adjustable gastric banding, and sleeve gastrectomy - with a focus~     on outcomes that are important to adults and adolescents with severe obesity: 1) changes in~     weight, 2) rates of remission and relapse of diabetes, and 3) major adverse events.~   "
63047|NCT02741661|"~     This study is a retrospective analysis where coronary arteriograms are being analyzed to~     determine whether the presence of tortuous coronary arteries correlate with any specific~     measures of left ventricular mass or left ventricular function on echocardiography.~   "
63048|NCT02741648|"~     The purpose of this trial is to study the effect that anemia and Red Blood Cell (RBC)~     transfusions have on oxygen levels in the digestive tracts of Extremely Low Birth Weight~     (ELBW) infants and to look for possible markers in a baby's blood, urine and/or stool that~     may lead to a better understanding of what makes an ELBW infant at risk for digestive tract~     problems such as necrotizing enterocolitis.~   "
63050|NCT02741609|"~     This study will evaluate Advanced Laboratory Services Borrelia diagnostic test by culturing~     Borrelia spirochetes from human serum in subjects with early or late Lyme disease.~      This is an 8 month study. Subjects entering the study will have two blood samples collected~     one month apart if they have early Lyme disease and one blood sample collected if they have~     late Lyme disease. Subjects who sign an IRB-approved consent form and meet the inclusion and~     exclusion criteria will be entered into the study. Subjects will be assigned a subject number~     upon entry and this number will be retained throughout the study.~   "
63051|NCT02741596|"~     This study is an open-label, long term safety and efficacy study to evaluate DX-2930 in~     preventing acute angioedema attacks in participants with Type I and Type II HAE.~   "
63052|NCT02741583|"~     prospective controlled interventional trial evaluating the efficacy of a 3-weeks asthma~     rehabilitation program at high altitude (3200m) and low altitude (760m) on lung function and~     asthma control.~   "
63053|NCT02741570|"~     The main purpose of this study is to compare nivolumab and ipilimumab with the extreme study~     regimen as first line treatment in patients with recurrent or metastatic squamous cell of the~     head and neck cancer~   "
63054|NCT02741557|"~     The purpose of the study is to evaluate the bioequivalence between Fixed-dose Combination~     (FDC) tablet formulation of Dolutegravir (DTG) 50 milligrams (mg) and Rilpivirine (RPV) 25 mg~     versus co-administration of the separate tablet formulations of DTG 50 mg plus RPV 25 mg, in~     the fed state. This pivotal bioequivalence study, is to serve as a pharmacokinetic (PK)~     bridge to the ongoing Phase 3 trials with the separate agents. This study will be conducted~     under fed conditions to appropriately mimic the conditions in the Phase 3 trials. This is a~     single-center, randomized, open-label, 2-period, single-dose, crossover study. A minimum of~     86 healthy adult subjects will be randomized such that a minimum of approximately 82~     evaluable subjects complete the study. The total duration of participation of a subject in~     this study will be approximately 8 weeks which includes a screening visit within 30 days~     prior to the first dose of study drug, two treatment periods each with a single dose of study~     drug and a follow-up visit within 12-17 days after the last dose of study drug. There will be~     a washout of at least 21 days between each dose of study drug.~      A blinded (for treatment) review of DTG and RPV plasma concentration data for approximately~     the first 40 subjects will be conducted. If the within-subject coefficients of variation~     (CVw%) for either DTG or RPV maximal drug concentration (Cmax) values are >=31%; a sample~     size re-estimation will be employed and additional subjects (beyond the 86 planned) will be~     randomized for treatment in the study. Following the re-estimation, it is possible that up to~     approximately 154 healthy adult subjects (68 new subjects in addition to the planned 86~     subjects above) will be randomized such that a maximum of approximately 146 evaluable~     subjects could complete the study.~   "
63055|NCT02741544|"~     To understand the safety and efficacy of Revlimid® 2.5mg and 5 mg Capsules (hereinafter~     referred to as Revlimid) in all patients who are treated with it under the actual condition~     of use pursuant to the conditions of approval.~        1. Planned registration period This period started on the date of initial marketing of~          Revlimid and will end at the time when the planned number of patients to be enrolled is~          reached.~        2. Planned surveillance period This period started on the date of initial marketing of~          Revlimid and will end on the day when the approval condition related to all-case~          surveillance is terminated.~   "
63056|NCT02741531|"~     The purpose of this study is to determine if partially filling the bladder after~     laparoscopic/robotic gynecologic surgery (for benign disease) shortens the time required to~     spontaneously void for patients to determine if this subsequently shortens patient stay times~     in the Post Anesthesia Care Unit (PACU) following surgery. This intervention would be~     compared to the current standard of care, which involves removing the patient's Foley~     catheter with an empty bladder and then giving the patient up to 6 hours to void in the PACU.~   "
63057|NCT02741518|"~     This is a randomized controlled pilot study to assess the microbiological and clinical~     impacts of Fecal Microbiota Transplantation (FMT) in patients with obesity. The investigators~     will prospectively enroll 20 adult patients who are obese (Body Mass Index of 35kg/m2 or~     higher) after providing written informed consent. The study participants will be randomized~     1:1 to either the treatment arm or the placebo arm. The treatment arm will receive an~     induction FMT with capsules followed by a monthly maintenance dose of oral capsules for 12~     weeks total. The placebo group will receive a placebo capsules for induction followed by~     monthly intake of oral placebo capsules for 12 weeks.~   "
63058|NCT02741505|"~     The primary purpose of this study is to explore the underlying mechanisms that link sleep to~     Alzheimer's disease (AD), with special focus on the clearance of metabolites in the~     extracellular space of the brain during sleep. Subjects will wear an actigraph for 1 week to~     determine regular daytime activity and sleep patterns. Subjects will then undergo partial~     sleep deprivation followed by 4 hours of in-lab nocturnal polysomnography (NPSG).~     Participants will be be asked to stay awake and active all day after the partial sleep~     deprivation with a new actigraphy secured by a hospital band to assure participants remain~     awake. They will seep inside an MRI machine for 90 minutes on the following night during~     their usual bedtime (established by 1 week actigraphy study.) Morphologic imaging, flow~     imaging and diffusion kurtosis imaging (DKI) will be performed on a 3T Siemens scanner.~   "
63059|NCT02741492|"~     This study is designed to evaluate pain control of continuous transversus abdominis plane~     (TAP) blocks placed for open inguinal hernia repair. The investigators hypothesize that there~     will be improved pain control when compared with sham blocks.~   "
63060|NCT02741479|"~     The purpose of this research is to determine if a specific type of elasticated athletic tape~     (Kinesio Tex Tape) increases muscle activation among professional level dancers.~     Investigators will determine if changes in muscle activation with the elasticated tape differ~     from changes experienced with no tape and/or sham tape, and if it coincides with subjective~     sense of muscle activation.~   "
63061|NCT02741466|"~     To evaluate the Sun Protection Factor (SPF) efficacy on human skin.~   "
63215|NCT02739464|"~     This study will measure efficacy of early in-patient exercise as an adjunct to current~     Standard of Care (SOC) for 96 patients in a multi-centre trial. The secondary purpose is to~     assess the efficacy of a personalized, structured, and quantifiable exercise program (MP10)~     carried out soon after admission until hospital discharge (including during the BICU stay and~     time on ventilation).~   "
63062|NCT02741453|"~     Central venous catheter placement is a common procedure in the intensive care unit and is a~     required skill for all residents working in the critical care setting. Central venous~     catheters (CVC) are placed for a variety of reasons including administration of caustic~     medications, administration of fluids or blood products for rapid resuscitation, access for~     hemodynamic monitoring or transvenous pacing, temporary vascular access for dialysis, or~     inability to obtain peripheral IV access. CVC's are routinely placed in the internal jugular~     vein in the Vanderbilt medical ICU and ultrasound guidance is used. Placement of the CVC on~     the right IJ instead of the left IJ is commonly preferred due to the more direct path to the~     superior vena cava. However, placement in the left IJ may be necessary for a variety of~     reasons. The investigators intend to compare the standard practice of residents and nurse~     practitioners placing IJ CVCs in the medical ICU against mandatory screening of the right and~     left IJ prior to selection of the CVC placement site. The investigators will accomplish this~     by assessing the relative first pass stick and overall success rates, the rate of aborted~     procedures, and the rate of complications between standard practice and mandatory screening~     of bilateral internal jugular veins prior to CVC site selection.~   "
63063|NCT02741440|"~     Background:~      Spinocerebellar ataxia type 7 (SCA7) is disease in which people have problems with~     coordination, balance, speech and vision. It is caused by a change in the ATXN7 gene. A~     mutation in this ATXN7 gene causes changes in eye cells, which can lead to vision loss. There~     is no cure for SCA7 but researchers are looking for possible treatments. Researchers need~     more information about SCA7. They want to collect vision and neurology related data from~     people with SCA7. They want to learn how and what changes in the eye and brain when the ATXN7~     gene isn t working properly.~      Objective:~      To learn more about SCA7 and its progression.~      Eligibility:~      People ages 12 and older with SCA7.~      Design:~      Participants will be screened with medical history and genetic testing from a previous~     National Eye Institute study or their personal physician.~      Participants will have at least 7 visits over 5 years. They will have 2 visits during the~     first week of the study. Then they will be asked to come back every year for the next 5~     years. Each visit will last several days and will include:~        -  Medical and eye history~        -  Several eye tests: some will include dilating the pupil with eye drops and taking photos~          or scans of the eyes.~        -  Electroretinography (ERG): Participants will sit in the dark with their eyes patched for~          30 minutes. After this, the patches will be removed and contact lenses put into the~          eyes. They will watch flashing lights and information will be recorded.~        -  Neurological exams: Sensation, strength, coordination, reflexes, attention, memory,~          language, and other cognitive functions will be tested.~        -  Brain MRI: They will lie in a machine that takes pictures of the brain.~        -  Blood and urine tests~        -  Optional skin biopsy: About 3 millimeters of skin will be removed for more research~          testing; this is half the size of a pencil eraser.~   "
63064|NCT02741427|"~     The purpose of this study was to compare the whitening effect of a toothpaste containing blue~     pigment with a conventional toothpaste and with at-home tooth bleaching; evaluate the~     subject's perception about tooth color improvement and; and evaluate the safety and~     acceptability of these products.~   "
63065|NCT02741414|"~     Recently studies showed that the eradication rate of H. pylori fail to exceed 80% and even~     falls into an unacceptable range. A major cause of treatment failure is associated with~     antibiotic resistance and poor patient compliance. However, the refractory infection of H.~     pylori is still existing, although patients have good compliance and receive standardized~     treatment. This phenomenon is likely attributed to the different ratio of sensitive and~     resistance in H. pylori, the difference of Amoxicillin resistance between in vivo and in~     vitro, the difference between phenotype and genotype or the influence of micro-environment in~     the stomach. In order to solve the refractory infection of H. pylori, investigators performed~     a muti-center study together with other 14 institutions. In this study, investigators will~     select the patients with refractory infection of H. pylori after two standardized treatment~     from patients with first eradication therapy of H. pylori infection. Then, investigators will~     perform a high-throughput sequencing for patients in groups. Finally, investigators will~     compare the differences between the patients with first successful eradication and patients~     with refractory infection of H. pylori, such as drug resistance gene mutation, phenotype and~     genotype, the mechanisms of Amoxicillin resistance and micro-environment in stomach.~   "
63066|NCT02741401|"~     The COMplementary hand-foot Massage to Improve experience of ilneSs trial (COMMIS trial) is a~     prospective, randomized trial and executed at a Western referral Centre: Zuyderland Medical~     Centre located Sittard-Geleen, The Netherlands concerning patients who underwent surgery for~     gastrointestinal malignancy. During 5 consecutive days, the intervention group received~     postoperatively hand-foot massage administered by trained volunteers.~      The aim of this study is to investigate the effect of complementary therapies concerning~     quality of life, pain, nausea, fatigue, sleeping problems, mood and stress in patients who~     underwent an operation as a result of gastrointestinal malignancy (stomach or colorectal).~   "
63067|NCT02741388|"~     This is an open label, multicenter, dose escalation, phase Ib study to determine the~     recommended phase II dose (RP2D), by assessing the maximum tolerated dose (MTD), safety and~     preliminary efficacy of selinexor in adult patients with relapsed/refractory B-cell~     malignancies receiving either R-DHAOx (Group A) or R-GDP (Group B). This dose escalation~     phase will be followed by an exploratory expansion phase in the same population with 12~     patients enrolled in each group, who will receive selinexor at the RP2D.~      The 3+3 design will be applied for dose escalation. The escalation will be performed~     independently in two distinct groups:~        -  Group A : Oral selinexor + R-DHAOx for 3 cycles (3-week cycles)~        -  Group B: Oral selinexor + R-GDP for 3 cycles (3-week cycles)~      The choice of the conventional immunotherapy regimen which will be administered to each~     patient, R-DHAOx (Group A) or R-GDP (Group B), is left at the investigator's decision before~     patient's inclusion. Different dose levels for selinexor administration will be examined~     sequentially in each group by the Dose Escalation Committee (DEC): 4 doses of selinexor per~     3-week cycle at 20 mg flat (Dose Level -1, DL-1), 40 mg flat (DL1), 60 mg flat (DL2) or 80 mg~     flat (DL3) will be taken orally by the patient on D1, D3, D8 and D10 of each cycle (dosing~     weeks = week 1 and week 2 of each 3-week cycle). Dose escalation will begin at DL1 and will~     continue until the MTD is exceeded or until the highest dose level defined in the study (DL3)~     is reached.~      Dose escalation to the next planned dose level will be decided by the DEC based on the number~     of DLTs observed during the DLT assessment period.~      The dose escalation phase will be followed by an exploratory expansion phase in the same two~     groups (Groups A and B), depending on the decision of the Independent Data Monitoring~     Committee (IDMC) after review of safety data at the end of dose escalation part.~      Patients enrolled in the expansion phase will receive selinexor at the RP2D defined by the~     IDMC, together with either of the conventional regimen R-DHAOx or R-GDP (left at the~     investigator's choice).~   "
63068|NCT02741375|"~     Aim: To investigate the efficacy of cerebral oximetry (CO) as an auxiliary diagnostic tool in~     confirming brain death (BD).~      Materials and Methods: This observational and interventional study was performed on patients~     with suspected BD in emergency departments and intensive care units. CO monitoring was~     performed for at least 6 h, and cerebral tissue oxygen saturation (ScO2) was recorded. Basal~     ScO2 values (basal ScO2), ScO2 values after 6 h (end ScO2), mean ScO2 values during~     monitoring (mean ScO2), and minimum (min ScO2) and maximum (max ScO2) ScO2 values observed~     during monitoring were recorded for all patients. Patients with diagnosis of BD confirmed by~     the organ transplantation and brain death committee were enrolled as the BD group and other~     patients as the non-BD group, and cerebral oxygen parameters were compared.~   "
63069|NCT02741362|"~     This is a Phase I-II open- label single-dose study in subjects with significant refractory~     Rheumatoid Arthritis (RA), relapsing Systemic Lupus Erythematosus (SLE) or Sharp's Syndrome~     (SS).~      This study will enroll a minimum of 20 subjects for RA, 20 subjects for SLE and 20 patients~     for SS. 6 week data of serum Tumor Necrosis Factor- alpha (TNFa), Interleukin- 6 (IL-6), C-~     Reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), Cluster of Differentiation~     (CD)4 +CD25 + Forkhead box P3(Foxp3) + regulatory T cells, Disease Activity Score for 28~     joints (DAS-28) score and pain score will be collected in all patients who are enrolled in~     the study for the RA group (Baseline and 6 weeks after). For the SLE group, Transforming~     Growth Factor- beta (TGF-β), TNFa, IL-6, Interleukin- 17 (IL-17), CD3+CD8-IL17A+ T helper-17~     (Th17) cells, CD4+CD25+Foxp3+ regulatory T cells and the Systemic Lupus Erythematosus Quality~     of Life Questionnaire (SLEQoL) score will be collected in all the subjects of this group. SS~     group will undergo the assessments of RA and SLE. Prior to the stem cell treatment, the~     patient will be assessed for 6 weeks by all the previously mentioned markers. Then, patients~     will receive the infusion of stromal vascular fraction cells containing the adult adipose~     derived stem cells 'aADSC' (single intravenous dose). The disease- modifying anti-rheumatic~     drugs (DMARDs) or the standard SLE treatment will not be interrupted with the exception of~     systemic steroids (excluding minimal maintenance dose of one steroid) during the duration of~     the study. Follow up visits will take place at 6 weeks, 3 Months and 6 Months after the cell~     infusion. Safety will be monitored on an ongoing basis, and an interim safety review will be~     conducted by the Investigator(s) and Sponsor after the first 10 patients have been enrolled~     and treated in each group.~   "
63070|NCT02741349|"~     The aim of the present prospective study is to further develop and validate a composite risk~     score predicting both ischemic and bleeding risk, based on epidemiologic, clinical,~     biological, and/or morphologic complementary data. First, the investigators will assess the~     predictive performance of current clinical risk scores. Second, the investigators will assess~     the potential predictive value of additional markers. Third, the investigators will aim to~     develop a new risk score.~   "
63071|NCT02741336|"~     Insomnia is a highly prevalent, often debilitating, and economically burdensome condition.~     Reviews of the literature indicate that there are ethnic differences in sleep behavior, with~     African Americans objectively and subjectively reporting more disordered sleep than Caucasian~     Americans.Chronic insomnia can have a significant impact on mental and physical health~     outcomes and has been associated with impaired cognitive performance, particularly, in areas~     of speed, attention, working memory, and executive function. In order to understand the brain~     mechanisms in sleep disorder both during resting state as well as during cognitive~     processing, the investigators will assess resting state EEG (during eyes-closed and eyes-open~     conditions) as well as ERP tasks for assessing decision-making and reward processing. The~     primary objective of the study is to evaluate the effect of a tailored, telephone-delivered~     cognitive behavioral intervention, versus a self- monitoring control condition, on symptoms~     of insomnia and its neurodynamic correlates.~      Hypotheses: Among Blacks subjectively reporting symptoms of insomnia, those randomized to the~     tailored, telephone-delivered CBT-I, compared with those randomized to the self-monitoring~     control group, will have: Hyp. 1: Greater reduction in symptoms of insomnia as measured by~     the Pittsburgh Sleep Quality Index. Hyp. 2: Greater neurophysiologic improvement (ERP, ERO)~     in the intervention condition in response to laboratory paradigms Hyp 3: Greater improvement~     in psychosocial functioning including reduction in depression and increase in quality of~     life.~   "
63072|NCT02741323|"~     Maraviroc (MVC) is a type of HIV medicine called a CCR5 inhibitor. This study will evaluate~     the safety and tolerability of MVC in HIV-infected adults receiving a kidney transplant.~   "
63073|NCT02741310|"~     Single center, parallel-group, double-blind, placebo-controlled concomitant therapy study in~     healthy subjects~   "
63074|NCT02741297|"~     The primary objective of this study is to characterize the real-world outcomes of spinal cord~     stimulation (SCS) therapy as an aid in the management of chronic intractable pain of the~     trunk, including unilateral or bilateral pain associated with the following: failed back~     surgery syndrome, intractable low back pain using the Boston Scientific (BSC) PRECISION~     Spinal Cord Stimulator System with MultiWave Technology.~   "
63075|NCT02741284|"~     Maternal oxygen administration for concerning fetal heart rate tracing (FHT) patterns is~     common practice on Labor and Delivery units in the United States. Despite the broad use of~     oxygen, it is unclear if this practice is beneficial for the fetus. The purpose of this study~     is to compare oxygen to room air in patients with Category II fetal heart tracings with~     regard to neonatal acid-base status, subsequent tracings, and production of reactive oxygen~     species~   "
63076|NCT02741271|"~     This study will compare the efficacy and safety of mometasone furoate/formoterol fumarate~     (MF/F) 100/10 mcg to mometasone furoate (MF) 100 mcg, both administered twice daily (BID) by~     metered-dose inhaler (MDI), in 5- to 11-year-old children with persistent asthma. This study~     will evaluate the change in forced expiratory volume in one second (FEV1) from baseline as a~     measure of pulmonary function~   "
63077|NCT02741258|"~     This is a randomized study, mepitel vs standard of care for the prevention and skin toxicity~     due to radiotherapy in patients with post-surgery breast cancer.~      Mepitel film will be placed on the skin of the patients just before the start of the~     radiotherapy and will be replaced once a week until the end of the radiotherapy. In case of~     skin toxicities mepitel film will be placed until resolution of toxicities.~   "
63078|NCT02741245|"~     This study will evaluate the efficacy and safety and tolerability of 2 dose levels of~     MK-0653H in Japanese participants. The primary hypotheses are that the administration of~     MK-0653H is safe and tolerable and that MK-0653H is superior to single entity of Ezetimibe~     and Rosuvastatin in percent reduction from baseline in low-density lipoprotein-cholesterol~     (LDL-C) after 12 weeks of treatment.~   "
63079|NCT02741232|"~     In this study, the investigators will compare the intraoperative opioid consumption for~     patients undergoing breast cancer surgery. The patients will be divided in two groups, the~     first one will receive a pectoral nerve block right after induction of anesthesia and the~     second one, the control group, will not receive the pectoral block. Our hypothesis is that~     the pectoral nerve block reduces the opioid consumption during the surgery.~   "
63080|NCT02741219|"~     The purpose of this multicenter study is to evaluate the effectiveness and safety of~     dexmedetomidine combined with sufentanil for patient-controlled analgesia after caesarean~     section~   "
63081|NCT02741206|"~     This is randomized control trial of a brief intervention called Bellevue ROSE (Reach Out Stay~     Strong Essentials). Bellevue ROSE is a manualized and highly structured interpersonal~     intervention that provides women with psycho-education about maternal depression and~     strategies for strengthening social support and connectedness. Investigators use motivational~     interviewing strategies to improve treatment compliance and resource acquisition~   "
63082|NCT02741193|"~     The aim of the study is to examine the degree of concordance between presurgical~     neuronavigation guided TMS (nTMS) and direct cortical stimulation (DCS) in identifying hand~     motor cortex in adults undergoing epilepsy surgery.~      Navigated transcranial magnet stimulation (nTMS), MagStim RapidStim2 Magnetic stimulation~     will be delivered to hand primary motor cortex, with positive and negative functional sites~     determined through surface electromyography (EMG).~      The study will involve patients ages 12-60 years, with planned neurosurgery involving~     implantation of intracranial subdural electrodes including over the precentral gyrus.~      Navigated transcranial magnet stimulation (nTMS), MagStim RapidStim2 Magnetic stimulation~     will be delivered to hand primary motor cortex, with positive and negative functional sites~     determined through surface electromyography (EMG).~      The primary outcome measure will be spatial correlation between topographic maps of hand~     motor representation obtained through nTMS compared to direct, extra-operative cortical~     stimulation performed as part of routine clinical care. A secondary outcome measure will be~     safety and tolerability of TMS in the epilepsy patients.~   "
63083|NCT02741180|"~     The primary purpose of this study is to improve the quality of Magnetic Resonance Imaging in~     patients with heart arrhythmia. Investigators will recruit 105 patients with arrhythmia and~     30 control volunteers over 3 years and will use two arrhythmia-tolerant imaging methods for~     diagnosis.~   "
63084|NCT02741167|"~     The purpose of this study is to assess the dynamics of inflammatory parameters in presence or~     absence of infectious complications after cytoreductive surgery with hyperthermic~     intraperitoneal chemotherapy.~   "
63085|NCT02741154|"~     study the effect of aromataze inhibitor induction together with short stimulation protocol by~     gonadotrphin releasing hormon antagonist in cases that expected to be poor responder before~     ICSI~   "
63086|NCT02741141|"~     In the 2010-french perinatal survey, the overall cesarean section (CS) rate during labour was~     21 % and 16% to 38% in case of dystocia.~      The definition of  dystocia  is traditionally based on the research led by Friedman in the~     1950's on a restricted population sample. Several studies over the last years seem to~     indicate that the different phases of labour are longer than originally described by~     Friedman.~      Our current hypothesis is that the application of a new definition of dystocia would enable a~     more appropriate management of labour.~   "
63087|NCT02741128|"~     The aim of the study is to evaluate the safety and immunogenicity of the Dengue vaccine in a~     population of special interest, such as HIV-positive adults.~      Primary Objective:~        -  To describe the safety of each injection of CYD dengue vaccine in HIV-positive adults.~      Secondary Objectives:~        -  To describe the humoral immune response to each dengue serotype at baseline and after~          each injection of CYD dengue vaccine in HIV-positive adults.~        -  To detect the CYD dengue vaccinal viremia post-Inj 1 in HIV-positive adults.~        -  To describe changes in CD4 count and HIV RNA viral load after each injection of CYD~          dengue vaccine in HIV-positive adults.~      Observational Objective:~        -  To describe the FV (YF, Dengue) serological status in the study population at baseline.~   "
63088|NCT02741115|"~     This study will evaluate the clinical efficacy and safety of udenafil, an orally~     administered, potent and selective inhibitor of PDE5, versus placebo for the treatment of~     adolescent subjects who have undergone the Fontan procedure.~   "
63089|NCT02741102|"~     This study will examine the feasibility of initiating a uterine transplant program for~     Absolute Uterine Factor Infertility (AUFI) at Brigham and Women's Hospital. The investigators~     plan to screen 30 patients with a goal of enrolling 10 patients. (5 donors and 5 recipients)~     After careful screening, appropriate candidates will undergo IVF, Uterine Transplantation,~     Embryo Transfer, Pregnancy and Delivery. Once the uterus is explanted, five years of~     follow-up is planned.~   "
63090|NCT02741089|"~     This monocentric, non-interventional observational registry study was designed in order to~     obtain data of patients with the indication for a flexible bronchoscopy to control and~     optimize a guideline conform therapy of these patients.~   "
63091|NCT02741076|"~     The purpose of this study is to evaluate the effect on pain intensity (PI) of structured~     discontinuation of long-term opioid analgesic therapy compared to continuation of opioid~     therapy in Suboptimal and Optimal Responders to high-dose, long-term opioid analgesic therapy~     for chronic low back pain (CLBP).~   "
63092|NCT02741063|"~     to investigate whether oxytocin alter attentional bias towards emotional expression faces in~     individuals with high and low autistic traits, and the brain mechanism of this effect~   "
63093|NCT02741050|"~     The goal of this proposal is to test the efficacy of a primary care-delivered, print-based~     physical activity intervention for Latinas with type II diabetes. The investigators will test~     the efficacy of this intervention by randomizing 80 Latinas with type II diabetes recruited~     through UCSD Health System primary care to either the adapted web-based physical activity~     intervention or standard of care, and assessing physical activity gains at six and 12 months.~     The ultimate goal is to develop a print-based physical activity intervention for diabetic~     Latinas that could be widely disseminated through primary care.~   "
63094|NCT02741037|"~     Mexican American women have significantly elevated rates of obesity and type 2 diabetes. The~     proposed study tests a novel intervention that capitalizes on an existing important family~     dyad (mothers and their adult daughters) to foster clinically significant and long-lasting~     health behavior change. If found to effective, this intervention strategy has great potential~     to address health disparities in this, and other, at-risk populations.~   "
63108|NCT02740855|"~     During the ethanol sclerotherapy procedure, the investigators will record doses of and time~     of ethanol injections and record ethanol concentrations in endtidal breath every 5 minutes.~     Furthermore after every ethanol injection the concentration will be measured every minute for~     5 minutes. To do so, the investigators will attach a breath alcohol testing device to the~     expiratory carbon dioxide measuring unit. Since this is the new standard of the university~     hospital Berne all patients undergo the same procedure. There is no study specific~     intervention. In this study the investigators will only document the breath alcohol levels,~     doses and timing of ethanol injections. All other data will be obtained from the anesthesia~     information system. During the two months of the study, the investigators will also record~     endtidal ethanol concentration after anesthesia in the postoperative care unit discharge from~     the unit.~      The intention is to show the correlation between injected ethanol doses and measured endtidal~     ethanol concentration over the entire time of the intervention.~   "
63095|NCT02741024|"~     This will be an open-randomised non-inferiority study to test the hypothesis that the risk of~     recurrent parasitaemia after 42 days is not worse in the group receiving the~     Artesunate-Amodiaquine (ASAQ) regimen than in the group receiving the Artemether-Lumefantrine~     (Coartem®) regimen. Children with uncomplicated malaria meeting the inclusion criteria will~     be enrolled (after their parent/caretaker has given informed consent), treated on site with~     the drugs under evaluation and followed-up for a period of 42 days. Drugs will be given under~     direct supervision, either at the clinic or at home. Follow-up shall consist of a fixed~     schedule of clinical and laboratory examinations. Based on clinical and laboratory findings,~     children will be classified as therapeutic failures (early or late) or adequate responders.~      The proportion of cases experiencing an in vivo therapeutic failure during the follow-up~     period will provide an estimate of the efficacy of the drug regimens. A Polymerase Chain~     Reaction (PCR) analysis will be carried out to differentiate true recrudescence due to~     treatment failure from episodes of re-infection. This proposal is compliant with the latest~     WHO recommendations for anti-malarial efficacy monitoring in high, medium or low transmission~     zones11.~   "
63096|NCT02741011|"~     Aim of this study is to evaluate the necessity of the radiological examinations of mentally~     handicapped or uncooperative patients.~   "
63097|NCT02740998|"~     Despite many years of research, controversy persists as to whether hormonal contraception~     promotes HIV acquisition. A number of observational studies on depot medroxyprogesterone~     acetate (DMPA) injection showed an increase in HIV risk and no evidence of increased risk~     with oral contraceptive pills. There are no human studies currently published on the impact~     of the levonorgestrel intrauterine device (LNG IUD) on HIV transmission risk and minimal data~     on the effects of the etonogestrel subdermal implant (ESI) on risk of HIV acquisition.~     Establishing whether any of these highly effective contraceptives increases the risk of HIV~     infection would have far-reaching public health implications, particularly in areas of high~     HIV prevalence such as sub-Saharan Africa, where injectable contraception accounts for nearly~     half of contraceptive use.~      Perturbations in the normal vaginal microbiota, or community of microorganisms inhabiting the~     vaginal body niche, have long been known to affect the risk of transmission of HIV. Studies~     have shown altered vaginal microbiota with DMPA injection and preserved vaginal microbiota~     with the LNG IUD, but no studies have compared these methods head-to-head or used~     culture-independent sequencing methodology. The investigators propose a prospective pilot~     study to evaluate the impact of different long-acting progestin contraceptive formulations on~     the vaginal microbiome. Specifically, the investigators aim to identify and compare~     metagenomics profiles associated with DMPA, LNG IUD, and ESI contraceptive use by community~     analysis of vaginal swab samples from women collected longitudinally after contraceptive~     method initiation. The investigators hypothesize that DMPA will increase community diversity~     in the vaginal microbiota, whereas the LNG IUD and ESI will not affect the balance of~     microorganisms in the vagina. Women who are planning to initiate DMPA, LNG IUD, and ESI~     contraception as well as controls not seeking contraception will be recruited for the study~     from Boston Medical Center (BMC), a tertiary care center with a racially and~     socioeconomically diverse patient population. Women will have longitudinal follow-up with~     self-sampling of the vagina for sexually transmitted infection testing and metagenomics~     analysis at method initiation, 2-3 months, and 6 months. Establishing the safest long-acting~     progestin contraceptive alternative will promote effective contraception use and lower rates~     of HIV acquisition worldwide.~   "
63098|NCT02740985|"~     This is a Phase I, open-label, multicenter study of continuous oral dosing of AZD4635~     administered as a single agent and then in combination with a PD-L1 antibody, durvalumab. The~     study design allows an escalation of dose with intensive safety monitoring to ensure the~     safety of the patients. The primary objective of the study is to determine the maximum~     tolerated dose of AZD4635 in combination with durvalumab.~   "
63099|NCT02740972|"~     The main objective of this study is to evaluate the safety of a high (80mg/kg) and low~     (40mg/kg) dose of NS-065/NCNP-01 delivered as an intravenous infusion in patients with~     Duchenne Muscular Dystrophy (DMD) amendable to exon 53 skipping. Additional objectives~     include tolerability, muscle function and strength, pharmacokinetics and pharmacodynamics.~   "
63100|NCT02740959|"~     This study is for an add-on study to the main study (Protocol No.: PH-CP012). The~     information of patients from main study will be collected by questionnaire survey and~     actigraphy measurement to evaluate the relationship between fatigue, depression and sleep~     disorder and the efficacy of PG2 after treatment.The association between symptom cluster and~     circadian rhythm will be also further explored.~   "
63101|NCT02740946|"~     This study aims to evaluate the effect of 5 months of exercise therapy for patients with~     irreparable rotator cuff tears.~   "
63102|NCT02740933|"~     This research study is studying a drug called Demeclocycline that may help brain surgeons see~     tumors with a microscope during surgery.~   "
63103|NCT02740920|"~     Studies have shown that the study drug, pembrolizumab, works by helping the immune system. In~     this way, pembrolizumab may help to slow the growth of melanoma or may cause cancer cells to~     die. Compared to standard treatments, pembrolizumab seems to lengthen the time patients lived~     overall and the time without their cancer getting worse.~   "
63104|NCT02740907|"~     Objective:~      Premolar autotransplantation represents an effective therapeutic option for the treatment of~     juvenile dentition in traumatic dental injury with tooth loss. Numerous studies report on the~     osteoinductive potency of the method, however, to date no quantitative data has been~     provided. The objective of this prospective clinical study was to quantitatively assess the~     bone and soft tissue levels after autogenous premolar transplantation by clinical and~     radiographic parameters.~      Materials/Methods:~      In the study 26 premolars were transplanted in 20 patients after traumatic dental injury~     (n=10) or tooth aplasia (n=16) in the upper front. Standard clinical parameters were~     evaluated. Based on a standardized photo documentation, the relative soft tissue level was~     measured in comparison to the healthy adjacent teeth. Radiographic findings involved the~     evaluation of root resorption, pulp canal obliterations and the relative bone height. Patient~     satisfaction was determined using a standardized questionnaire.~   "
63105|NCT02740894|"~     Not significantly increased survival in T/T~   "
63106|NCT02740881|"~     Adolescent substance abuse results in significant negative outcomes and extraordinary costs~     for youths, their families, communities and society (societal costs estimated at over $400~     billion annually and greater than costs for any other health problem). There is a clear~     public health need for improving and expanding the delivery of evidence-based treatments for~     adolescent substance use, but despite this clear need, there is a large divide between~     science and practice. This project will develop a cost-effective, easily accessible,~     web-based Training Support System (TSS) for Contingency Management that incorporates ongoing~     training, feedback, and support provided to both counselors and their community-based~     agencies.~   "
63107|NCT02740868|"~     Aim of this study is to evaluate image quality and reproducibility of Xenon-129 Magnetic~     Resonance Imaging (MRI) and to evaluate changes in lung structure and function in~     participants with cystic fibrosis (CF) and asthma compared to healthy controls using~     Xenon-129 MRI.~   "
63109|NCT02740842|"~     Alive & Thrive (A&T) is a multi-year initiative to improve infant and young child feeding~     (IYCF) practices. During Phase 1 (A&T-1, 2009-2014), funded by the Bill & Melinda Gates~     Foundation, A&T aimed to reduce undernutrition and death caused by suboptimal IYCF practices~     in three countries - Bangladesh, Ethiopia, and Viet Nam.~      In 2014, IFPRI in collaboration with DATA conducted the endline survey in Bangladesh. The~     overall findings of the evaluation indicate that A&T's work in Bangladesh is a remarkable~     success story of scaling up what has been challenging to date in the field of nutrition:~     complex, high intensity and at-scale behavior change communications interventions.~      In 2016, a follow up study will be conducted to determine the sustained impacts on IYCF~     practices, expansion of operations and promoted practices into new areas, and diffusion of~     IYCF information, two years after the termination of external project support.~   "
63110|NCT02740829|"~     Peripheral glucagon action increases hepatic glucose production. In rodents hypothalamic~     action of glucagon paradoxically suppresses glucose production. Intranasally administered~     peptides have been shown to preferentially enter the central nervous system. We assessed the~     effects of intranasal glucagon on hepatic glucose production~   "
63111|NCT02740816|"~     The purpose is to investigate how menstrual blood differs from systemic blood to evaluate if~     menstrual blood could be utilized as a natural and non-invasive access to blood for regular~     health monitoring and early diagnostics.~   "
63112|NCT02740803|"~     Caries prevalence has declined significantly since the introduction of fluoridated~     toothpastes. Since then, different toothpaste formulations and concentrations have been~     introduced to the market with varying levels of efficacy. There are several commercially~     available toothpastes to choose from and only with the aid of sound methodological research,~     can the best evidence-based oral education advice be delivered.~      This is a double-blinded randomised controlled trial that aims to measure the salivary~     fluoride concentration following tooth-brushing with several toothpaste formulations. Power~     calculations were performed using PASS 11.0 software, and calculations showed that 3~     participants are needed in each group in order for results to be considered as significant.~     We will aim to recruit five to seven participants in each of the 12 groups. Research will be~     publicised by means of flyers and circulating emails amongst University of Leeds students.~     Information sheets will be provided to all participants and informed consent will be~     obtained.~      Each participant will brush with one of 6 different formulations of toothpastes either with~     or without water rinsing post-brushing. Participants will randomly be assigned to groups~     using an online random team generator. Saliva will be collected six times once before~     brushing and at 1, 15, 30, 60 and 90 minutes post-brushing. Samples will be analysed using~     fluoride ion-specific sensitive electrode connected to an ion analyser.~      A statistician's help will be sought for analysis of the results. After the analysis stage,~     the codes of the toothpastes will be broken.~   "
63113|NCT02740790|"~     Evaluate immunogenicity and safety of recombinant human papillomavirus bivalent ( types 16~     and 18 ) vaccine ( Yeast )in different age group. And evaluate persistence of immune response~     in 9-17years age group. To demonstrate that 9-17years age group was non-inferior to 18-26~     years age group and 27-45 years age group in terms of immunogenicity.~   "
63114|NCT02740777|"~     To evaluate the immune non-inferiority, as measured by antibody responses, of a 2-dose~     immunization schedule (0, 6 months) of recombinant human papillomavirus virus-like particle~     vaccine (type 16 and 18 L1 proteins, yeast) (hereinafter referred as HPV-2 vaccine) in~     adolescent females aged 9 to 14 years in comparison to 3-dose immunization schedule (0, 2, 6~     months) in young females aged 18 to 26 years.~   "
63115|NCT02740764|"~     Aging is often associated with multiple chronic conditions conducting increased consumption~     of drugs. Drug therapy is necessary for the treatment of many diseases. However, misuse of~     drugs, particularly linked to the potentially inappropriate prescribing and polypharmacy,~     increases the iatrogenic risks and can lead to adverse events such as falls, cognitive~     decline, increased use to the health system: hospital admissions, emergency room visits, and~     institutionalization. These problems are common since about 20% of emergency room use in~     elderly patients due to an adverse event related to drugs. Nearly 28% of adverse events~     related to drug prescriptions could be avoided.~      Interventions to optimize drug therapy showed a reduction in the number of potentially~     inappropriate medications, but their impact on health, has rarely been evaluated. If an~     association with death has been established, the link with the loss of functional autonomy,~     which leads to reduced quality of life and significant cost of care, has not been~     investigated. The evolution towards functional disabilities, frequent with aging has many~     causes, among which some could be prevented. The optimization of drug prescriptions could~     thereby delay or prevent the loss of functional autonomy by reducing the risk of adverse~     events, such as falls or cognitive decline and improving the management of chronic diseases.~     Our hypothesis is that an optimization program of the drug prescribing may slow progression~     to functional dependence. To assess the effect of the optimization program of drug~     prescribing on the level of functional autonomy, a multicenter Randomized Controlled Trial~     will be conducted in geriatric and memory consultations.~      Expected results The implementation of the OPTIM program should enable optimization of drug~     prescribing in elderly patients and therefore slow or prevent progression to addiction. It~     should also help to develop and strengthen collaboration and communication between the team~     of geriatric consultation, the clinician pharmacist and referring physicians in town (private~     practice). In addition, pharmaceutical notice sent to referring physicians should help raise~     awareness of the prescription of drugs in these patients.~   "
63116|NCT02740751|"~     Herbal teas with galactogoge effects have been used extensively in recent years in order to~     increase the amount of breast milk in lactating mothers. We also investigated whether a~     sleep-induced herbal tea (Still-Tee; Mamsel®) was effective in regulating the sleep of these~     mothers. Plain water was used as placebo.~   "
63117|NCT02740738|"~     To investigate the association between grip strength and preoperative pain threshold as~     measured by pressure algometer and validated pain outcome surveys.~   "
63118|NCT02740725|"~     Purpose: of determining the role of Interactive Binocular Treatment (I-BiTTM) as a~     complementary method of patching in amblyopia therapy.~      Materials and Methods: In this randomized clinical trial study, 50 unilateral amblyopic~     children (25 male/25 female) less than 10 years with either best corrected visual acuity~     (BCVA) ≤0.3 LogMAR (Logarithm minimum angle of resolution) in amblyopic eye or difference of~     VA≥2 lines between two eyes will be included. Patients will be classified in the case and~     control groups (25 in each), randomly. Patching will be recommended in both, cases will also~     received I-BiTTM. The child will be asked to play I-BiTTM games through glasses with~     conjugate colored filters. Patching was continued for one month more in both groups. VA and~     stereoacuity were measured at baseline, one month at the end of I-BiTTM treatment and one~     month after I-BiTTM treatment.~   "
63119|NCT02740712|"~     The purpose of this study is to assess pharmacokinetic concentrations of multiple probes~     alone followed by assessment of the same drug pharmacokinetic concentrations when the patient~     has steady-state exposure to rucaparib followed by cycle-by-cycle treatment with rucaparib~     continuing until disease progression or other reason for discontinuation.~   "
63120|NCT02740699|"~     Background:~      Coronary artery disease causes plaque in arteries. This can cause stroke or heart disease.~     Drugs called statins might shrink plaque. Researchers want to study how CT scanning can~     determine if an individual s arterial plaque has decreased while taking statins.~      Objectives:~      To measure the change in coronary artery plaque volume in people treated with high-intensity~     statin therapy using CT and MRI scans. To study the metabolic activity of plaque in arteries.~     To determine how well plaque measurements from heart CT scans can be replicated.~      Eligibility:~      Men ages 45-75 and women ages 50-75 who are good candidates for statin treatment~      Design:~      Visit 1: participants will be screened with:~        -  Medical history~        -  Blood tests~        -  Heart MRI and CT scan: An IV inserted into an arm or hand vein removes blood and injects~      contrast, and medicine if needed. Participants lie on a table that slides into a machine that~     takes pictures of the body. For the CT scan, if their heart rate is too high, they get~     medicine to lower it. They breathe in a special way, holding their breath for 5 seconds.~      Participants will begin high-intensity statin treatment.~      Participants will have 7 more visits over 3 years. All visits include blood tests and~     medication review. Some may also include:~        -  Statin treatment adjustment~        -  CT scan~        -  MRI scan~        -  Physical exam~      Participants may join the PET Substudy. This includes 5 more visits during the study. These~     include:~        -  Getting an IV in an arm vein~        -  Blood tests~        -  PET scans: They fast 12 hours before.~      Participants may join the Reproducibility Substudy if they had a slow heart rate during their~     first CT scan. This includes 1 additional heart CT scan 4 weeks later.~   "
63121|NCT02740686|"~     This study will examine the inflammatory response to exercise encompassed as part of a~     standard pulmonary rehabilitation programme in patients with chronic obstructive pulmonary~     disease (COPD). Patients will be split into two groups, frequent exacerbators or infrequent~     exacerbators, dependent upon exacerbation history to compare responses to pulmonary~     rehabilitation amongst phenotypes.~   "
63122|NCT02740673|"~     Little is known about the causes and degree of cognitive dysfunction in patients with Chronic~     Obstructive Pulmonary Disease (COPD), especially their driving abilities. The purpose of the~     study is to examine the cognitive skills of patients with COPD by using a driving simulator~     and to examine correlations to factors that may predict cognitive dysfunction in these~     patients.~   "
63123|NCT02740660|"~     The purpose of this study is to determine whether taking a combination of caffeine and~     albuterol three times per day will increase muscle and decrease fat in your child's body and~     to determine how these medications make your child feel. Albuterol is approved by the FDA for~     the treatment of asthma. It is not approved to increase muscle and decrease body fat in~     children.~   "
63124|NCT02740647|"~     Orthognathic surgery is the state of art of the maxillofacial surgery, it fix and normalize~     facial abnormalities and create a harmony between the different tissues compounding the face~     (bone, soft tissue and dental structures). It is a common procedure and it is done in order~     to correct a dentofacial and skeletal deformities.~      There is an inevitable risk of complications with this type of surgery. While postoperative~     infections are the most common complication (2% to 33.4%).~      preoperative administration of antibiotics have been proven to be effective in reducing the~     postoperative infection rate, while, the quality of the currently available literature in~     prescribing continues postoperative antibiotics is questionable and there is still no~     consensus on its efficacy.~      Unwise administration of antibiotics may cause several unwanted side effects such as~     gastrointestinal symptoms, allergy reactions, high costs, etc… while the most worrisome side~     effect is a bacterial resentence.~      The objective of this study is to investigate the efficacy of postoperative antibiotics. And~     will try to state a consensus in prescribing postoperative antibiotics. By conducting a~     prospective, randomized, double-blind, placebo-controlled study, that will explore and~     analyze the efficacy of postoperative administration of Amoxicillin Clavulanate versus~     placebo in reducing the rate of postoperative infections in 60 healthy patients.~   "
63125|NCT02740634|"~     This is a neuroimaging study designed to learn more about amyloid and tau burden in the brain~     of patients with Atypical Alzheimer's Disease and how burden may change over a one year~     period.~   "
63126|NCT02740621|"~     In this study, the risk of opioid medications on coronary heart disease in adults is~     investigated. Patients with the necessity of a coronary angiography and control patients with~     a non-cardiac disease of the same hospital are inquired with a standardized questionnaire~     about demographic and clinical risk factors for heart attack. An impact of opioid medications~     on coronary heart disease is hypothesised (MIOP).~      In addition, all patients with coronary angiography should be consulted twice (after 3 and 6~     months) to find out how many of these patients have developed a refractory angina pectoris~     (TRAPS).~   "
63127|NCT02740608|"~     This study is designed to determine if a rejected liver is viable using normothermic machine~     liver perfusion (NMLP). It aims to~        1. establish the suitability of livers which have been declined by all UK liver transplant~          centres by monitoring their function on the NMLP machine; and,~        2. transplant the liver if its function on the machine is satisfactory allowing it to be~          transplanted.~   "
63128|NCT02740595|"~     Randomized controlled trial of electronic cigarettes with nicotine, without nicotine, and~     sham control, on endothelial function and markers of oxidative stress.~   "
63129|NCT02740582|"~     The purpose of this study is to determine the effects of tolcapone on decision making and~     alcohol intake using a laboratory bar (on-site alcohol self-administration) in alcohol~     drinkers.~   "
63130|NCT02740569|"~     Scleroderma is an autoimmune disease with skin manifestations and may have pulmonary~     involvement. Obstructive sleep apnea (OSA) may also be seen in scleroderma. Less is known~     regarding the prevalence of OSA in scleroderma and its association with pulmonary~     involvement.~   "
63144|NCT02740387|"~     This is a 1-year, multicenter, Phase 2, open-label safety study in subjects with unilateral~     Meniere's disease. Subjects will receive 1 intratympanic (IT) injection of 12 mg OTO-104 at~     3-month intervals for a total of 4 injections total.~   "
63145|NCT02740374|"~     The purpose of this study is to determine whether the use of ROTEM, during spinal surgery is~     effective on diminishing the total blood loss and the risk of Allogenic Transfusion of Blood~     Products vs control cases without ROTEM assessment.~   "
63131|NCT02740556|"~     There is limited data outside of clinical trials on adherence to once daily~     ledipasvir/sofosbuvir regimens. Many patients present with known barriers to medication~     adherence including untreated psychiatric illness and substance use disorders, cognitive~     impairment, and low health literacy. The goal of this study is to evaluate the baseline level~     of adherence to ledipasvir/sofosbuvir in a real-world clinic population and compare this to~     the level of adherence in patients provided with additional adherence support. Medication~     adherence in this study will be evaluated using AdhereTech, a wireless pill monitoring device~     that measures the dosage and time a medication was taken. Using cellular technology,~     AdhereTech can be used passively to collect data on when a medication is taken, when a refill~     is needed, and how often the bottle is opened. AdhereTech also can be used actively to~     monitor adherence and provide feedback to subjects using the device. When actively~     monitoring, AdhereTech can be set up to provide live feedback to a subject by lighting up,~     sounding chimes, and sending phone/text/email alerts to remind patients to take their~     medication (see attached PowerPoint presentation). HepCure is a web-based tool kit in the~     form of a dashboard for medical providers (MDs and NPs) and an application (or app) for~     patients. The app allows patients to become active participants in their treatment by~     enabling them to set medication reminders, record doses taken, and communicate their~     adherence to their medical provider using the provider dashboard.~   "
63132|NCT02740543|"~     Asthma is a heterogeneous disease, and although much is understood about mechanisms of~     inflammation in allergic asthma, less is known about mechanisms of irritant-induced asthma~     (IA). Understanding the underlying similarities and differences in mechanisms of these two~     types of asthma will help focus current treatments and lead to development of new therapies.~     There is a longstanding NYU/Bellevue Asthma registry (NYUBAR), with a large population (N =~     900) of asthma cases and controls, a program that has been housed at the CTSI (formerly~     GCRC). The destruction of the World Trade Center (WTC) resulted in massive dust, gas and fume~     exposures to local residents, workers and cleanup workers and individuals involved in rescue~     and recovery and adverse respiratory health effects of this disaster are reported more than 7~     years after 9/11. Many responders, as well as those exposed as residents or local workers,~     have developed IA, asthma that arises after a lag from an environmental exposure . The WTC~     Environmental Health Center (WTC EHC) is one of the three New York City (NYC) WTC Centers of~     Excellence and the only one that focuses on treatment and monitoring of local workers and~     residents. As such, it has a large population of individuals with irritant-induced asthma. It~     has been proposed to use participants from the NYUBAR and the WTC EHC to expand the knowledge~     of irritant and allergic asthma. Non-invasive studies allow for the assessment of airway~     inflammation, a non-specific response to environmental exposure and injury. Recent~     technologies also allow for assessment of microRNA (miRNA), small RNAs that regulate gene~     expression at the post-transcriptional level and thus serve as a pathway to regulation of~     inflammation. The hypothesis will be tested in that airway inflammation in irritant and~     allergic asthma may be similar, but result from divergent miRNA regulatory pathways expressed~     in sputum cells. These studies will provide preliminary data for future studies that will~     help identify biological pathways to categorize these asthma phenotypes and target future~     treatment interventions.~   "
63133|NCT02740530|"~     This study aims to test the efficacy of a type of non-invasive brain stimulation (NIBS),~     known as repetitive transcranial magnetic (rTMS) stimulation, in improving mobility,~     particularly gait stability and variability, and executive dysfunction in older adults. The~     study will be conducted in forty older adults (≥60 years) with a diagnosis of executive~     dysfunction.~   "
63134|NCT02740517|"~     Trial to demonstrate that the intended user population can use the device unsupervised in the~     home and collect data that is of sufficient quality to be successfully analysed for~     respiration rate.~   "
63135|NCT02740504|"~     A trial conducted within the company with a new non-contact respiration rate (RR) sensor. The~     device was compared for accuracy in RR measurement with a cleared device, the SOMNOScreen~     Easy, which uses chest effort bands.~      The RR was measured over a short duration on subjects sitting upright in a chair, with the~     non-contact sensor at various distances from the subject. A total of 20 subjects were tested,~     from both genders, selected to represent a wide range of age and body mass index~   "
63136|NCT02740491|"~     The main objective of this study is to describe the evolution in quality of life (QLQ-C30)~     for patients receiving breast cancer care at 3, 6 and 12 months after a remission~     consultation.~   "
63137|NCT02740478|"~     The aim of the trial is to prove that the Reassure10.5 GHz sensor is equivalent in~     performance to the SomnoScreen Plus RC in indicating the breathing rate of adult subjects~     over a number of hours when the subjects are lying still or in bed asleep~   "
63138|NCT02740465|"~     This prospective, multicenter, cohort study is designed to validate Anxiety Inventory~     Respiratory Disease questionnaire in patients with Chronic Obstructive Pulmonary Disease~     (COPD).~      The primary purpose of this study is to assess the validity of the Anxiety Inventory~     Respiratory (AIR) scale in detecting anxiety in relation to the DSM-V criteria in patients~     with COPD.~        -  To evaluate associations between COPD symptom scores assessed by the CAT questionnaire~          and MMRC dyspnea scale and measures of depression and anxiety~        -  To evaluate associations between physiologic measures of lung function (spirometry) and~          exercise tolerance (6 minute walk) and measures of depression and anxiety~        -  To evaluate associations between exacerbations of COPD and the prevalence of anxiety and~          depression in a cohort of COPD patients~   "
63139|NCT02740452|"~     The assess results of Anterior Cruciate Ligament (ACL) repair with the Ligamys® surgical~     technique versus standard technique.~      The aim of the study is to compare (laxity, instability, and safety) these two types of~     treatment by using a prospective, randomised multicenter analysis.~   "
63140|NCT02740439|"~     The proposed work will investigate the effects of avocados on abdominal obesity and glycemic~     control among overweight/obese adults.~   "
63141|NCT02740426|"~     This clinical trial is designed to evaluate the efficacy of single immediate intravesical~     chemotherapy instillation in the prevention of bladder recurrence after diagnostic~     ureteroscopy for upper tract urothelial carcinoma (UTUC) patients.~   "
63142|NCT02740413|"~     The overall aim of the study is to describe demographic and clinical characteristics,~     treatment patterns and outcomes, in the populations of hemophilia patients treated with~     BeneFIX and ReFacto/ReFacto AF in Sweden~   "
63143|NCT02740400|"~     This is a randomized controlled trail aiming at comparing the diagnostic value and safety of~     endobronchial ultrasonography with a guide sheath(EBUS-GS) and computed tomography-guided~     transthoracic needle biopsy(CT-TTNB) for peripheral pulmonary lesions (PPLs). Patients~     eligible for the inclusion criteria are diagnosed using either EBUS-GS or CT-TTNB randomly.~     The diagnostic indicators such as sensitivity, specificity, and accuracy are compared between~     the two groups. Post-procedure complications are recorded.~   "
65907|NCT02704338|"~     Separated and expanded the CD4+CD25+CD127- Tregs from peripheral blood of autoimmune~     hepatitis patients and administrate the cells (5 x 106 cells/kg) into patients.~   "
63147|NCT02740348|"~     The purpose of this trial is to determine whether setting up a follow-up appointment for~     patients who received treatment and were discharged from the emergency department increases~     their compliance with the follow-up appointment. We are enrolling patients who need a~     follow-up visit, have health insurance but report do not have a primary care doctor. Patients~     are randomized to one of three treatment groups: (1) assistance setting up a follow-up~     appointment by a research assistant using ZocDoc; (2) ZocDoc information given to the subject~     to set up follow-up appointment by him/herself; or (3) usual discharge instructions by ED~     staff. Subjects are phoned approximately 2 weeks after the ED visit and asked whether they~     completed a follow-up visit, satisfaction with their ED visit, satisfaction with their~     follow-up visit, and additional ED treatment and recovery.~   "
63148|NCT02740335|"~     To demonstrate that the efficacy of OCTAPLEX as a reversal agent in patients under Vitamin K~     Antagonist (VKA) therapy with the need for urgent surgery with significant bleeding risk is~     clinically non-inferior to that Beriplex® P/N (Kcentra).~   "
63149|NCT02740322|"~     The sensitivity and specificity of the Hum Test is being investigated in it's ability to~     detect conductive hearing loss. The hum test is simply elicited by asking the subject to hum~     to him or herself for a few seconds at both a high and low pitch that is comfortable for the~     subject. The subject is then asked if the hum was heard on one side more than the other (left~     or right), or if the sound was equal on both sides. To simulate conductive hearing loss, ear~     plugs will be placed in one of the subject's ears. We will elicit the hum test as well as the~     standard Weber test and audiogram across two conditions, with an ear plug and without an ear~     plug. From this, it is hoped to assess how the Hum Test compares to the audiogram (gold~     standard) in detecting conductive hearing loss as well as how it compares to the standard~     Weber test. If the Hum Test demonstrates strong sensitivity and specificity in detecting~     conductive hearing loss, it could have application as being utilized as an alternative to the~     standard Weber test, or in a setting where a formal physical examination may not yet be~     possible but where the etiology of a patient's hearing change could be quickly assessed~     remotely and thus the urgency of intervention/ consultation could then be determined.~   "
63150|NCT02740309|"~     Study design: At baseline, all adolescents and young adults with IBD ages 12-21 years will be~     screened for anxiety and depression symptoms using the PHQ-9 and the Screen for Child Anxiety~     Related Disorders (SCARED) during a routine medical visit in the pediatric gastroenterology~     clinic. Individuals who screen positive for depression or anxiety will be assessed to confirm~     diagnoses using the anxiety and M.I.N.I. 6.0. Participants will also complete a psychosocial~     risk assessment as well as medical and socio-demographic inventories. The investigators will~     include youth that meet full criteria for major depressive disorder and any anxiety disorder,~     dysthymic disorder, and any adjustment disorder. The investigators will also include patients~     with subclinical symptoms that have significant psychosocial stressors in addition to their~     medical illness. Patients will be excluded if they have active suicidal ideation with plan~     requiring ER referral, bipolar disorder, psychosis, substance dependence, eating disorders,~     or significant intellectual disability/developmental delay. Participants meeting inclusion~     criteria will be randomly assigned to four sessions of IBBT administered on-site by a Fink~     social worker or treatment as usual (TAU), which is a facilitated community referral for~     mental health treatment.~   "
63151|NCT02740296|"~     Depression is one of the most common symptoms of multiple sclerosis (MS) with a life-time~     prevalence of major depressive disorder (MDD) of up to 50%. Depression occurs more frequently~     in MS than in other chronic diseases including other neurological and inflammatory disorders~     and may contribute to lower quality of life, cognitive problems, difficulties at work, and~     poorer long term health outcomes. Despite its clinical relevance, the biological mechanisms~     which may be responsible for the high risk for MS patients to develop depression are unknown.~      In this observational study, investigators explore the molecular mechanisms responsible for~     the impaired regulation of immune cells in relapsing-remitting (RR) MS patients with~     depression. Investigators will compare the molecular and phenotypical profile of immune cells~     obtained from RRMS patients with clinical depression (n=50), matched MS patients who do not~     suffer from depression (n=50) as well as matched healthy controls (n=50) and matched patients~     with depression but without a comorbid neurological disorder (n=50).~   "
63152|NCT02740283|"~     The main purpose of the study is to evaluate an OGTT at 18 to 20 gestational weeks as an~     early diagnosis method of GDM in low risk pregnant women. By investigating maternal and~     neonatal outcomes that are associated with the early OGTT and regular OGTT results, the study~     will provide a evidence for the most appropriate time to perform an OGTT in pregnant women.~   "
63153|NCT02740270|"~     The purpose of this trial is to explore the clinical utility of two investigational~     antibodies in patients with advanced cancer or lymphomas.~      This is a multi-center, open-label Phase I/Ib study. The study consists of two dose~     escalation parts and two dose expansion parts testing GWN323 as a single agent or GWN323 in~     combination with PDR001. The dose escalation parts will estimate the MTD and/or RDE and test~     different dosing schedules.~      The dose expansion parts of the study will use the MTD/RDE determined in the dose escalation~     part to assess the activity, safety and tolerability of the investigational products in~     patients with specific types of cancer and lymphomas.~      Approximately 264 adult patients with advanced solid tumors or lymphomas will be enrolled.~   "
63154|NCT02740257|"~     The primary objective of Part One of this study is to determine the sensitivity of an~     automated total body digital photography (TBDP) app to detect color and size changes in the~     human skin, and whether a new lesion has arisen.~      The primary objective of Part Two is to test the sensitivity and specificity as well as~     feasibility of field use of an automated TBDP app to detect pigmented and non-pigmented skin~     lesions in high risk populations.~   "
63155|NCT02740244|"~     The aim is to evaluate the evaluate the clinical interest and the safety of repetitive~     transcranial magnetic stimulation (rTMS) delivered as intermittent Theta burst~     stimulation(iTBS) on severity of depression in patients with treatment-resistant bipolar~     disorder.~   "
63238|NCT02739165|"~     The purpose of this study is to assess the efficacy and safety of the intravenous drip~     infusion of ART-123 in patients with acute exacerbation of idiopathic pulmonary fibrosis~     (IPF) in a multicenter, double-blind, randomized, placebo-controlled, parallel group~     comparison study, and to confirm its superiority over placebo with survival rate on Day 90 as~     the primary endpoint.~   "
63156|NCT02740231|"~     Osteoarthritis (OA) is the most common joint disease affecting millions of people around the~     world, for which there is unfortunately no cure. Among existing therapies,~     viscosupplementation, i.e., the injection of hyaluronic acid into the joint, has an~     established place in the symptomatic treatment of knee OA.~      The present Phase IIb/III aiming to assess the safety and efficacy of JTA-004 is organized in~     two phases. With results obtained in the first phase the best dose of JTA-004 is determined,~     and the efficacy of the selected dose will then be confirmed in the second phase.~   "
63157|NCT02740218|"~     This is a retrospective, multi-center observational cohort study. This study will be~     implemented first in Germany (approximately 50 sites), the United Kingdom (approximately 20~     sites) and Sweden (approximately 25 sites), followed by a selected number of countries in~     Europe, depending on apremilast local availability. The design of this apremilast~     retrospective study aims to provide clinical information regarding the treatment initiation~     and outcomes in psoriasis patients when prescribed apremilast in real world settings. In~     addition, this study is aiming at capturing physicians' and patients' treatment goals when~     initiating apremilast and whether these goals are achieved following apremilast use. This~     study is primarily descriptive in nature, and no a priori hypotheses are specified. Patients~     must voluntarily sign an informed consent form, be 18 or over, have been diagnosed with~     plaque psoriasis and have been treated with apremilast during the previous 5-7 months to~     participate in this study. They must not be involved in any other clinical study involving~     apremilast.~   "
63158|NCT02740205|"~     The purpose of this trial is to evaluate the efficacy and safety of the implementation of an~     Algorithm for enteral nutrition support compared with usual standard practice in non-critical~     hospitalized patients: ASNET algorithm.~   "
63159|NCT02740192|"~     This is a randomized, double blinded, standard of care controlled clinical trial. All adult~     patients over eighteen desiring total knee arthroplasty will be eligible. The study compares~     pain control, opioid consumption, and physical exam findings in patients undergoing total~     knee arthroplasty between patients receiving adductor canal block and those who receiving~     periarticular injection alone.~   "
63160|NCT02740179|"~     HIV-infected individuals treated with antiretroviral medications are living longer, but have~     an increased risk of heart disease when compared to non-HIV-infected individuals. A hormone~     called aldosterone, which regulates blood pressure and sodium balance, is elevated in the HIV~     population in association with with increased belly fat and altered glucose metabolism.~     Elevations in aldosterone hormone may also be associated with abnormal blood flow,~     inflammation, and coronary plaque in the heart. This study is being conducted to evaluate~     whether therapies to reduce the actions of aldosterone may decrease the burden and~     progression of heart disease in the HIV population.~   "
63161|NCT02740166|"~     Esophageal variceal bleeding is a severe complication of portal hypertension. Banding~     ligation plus non-selective beta-blockers is the current recommendation for prevention of~     recurrent bleeding. However, the optimal duration of use of non-selective beta-blockers is~     not well defined. This study aims at comparing the rebleeding rate and adverse effects in~     patients using or without using propranolol after eradication of esophageal varices.~   "
63162|NCT02740153|"~     Urea cycle disorders (UCD) are genetic disorders caused by the liver's inability to break~     down ammonia from proteins; ammonia then accumulates and is toxic to the brain. UCD cause~     brain damage and intellectual and developmental disabilities and even death.~      Treatment for UCD is either conservative management which involves a low-in-protein diet,~     drugs, and amino acid supplements or liver transplantation; each carries their own risks.~      This study aims to help patients to make the decision about different management alternatives~     by providing them with scientific information that is currently lacking.~      Aim 1 of this study will compare survival, neurocognitive function, and patient-reported~     quality of life. Aim 2 of this study will consist of interviews and focus groups with~     patients, their families, and their medical providers to determine important issues to~     consider when deciding whether to continue conservative management or opt for liver~     transplantation.~   "
63163|NCT02740140|"~     This observational epidemiologic study with nested cross-sectional and longitudinal aims will~     evaluate host immune response to mixed chronic infections (Helicobacter pylori, latent~     tuberculosis, intestinal helminthiasis) in recent US immigrants.~   "
63164|NCT02740127|"~     During penile prosthesis surgery, patients are given general anesthesia in combination with~     other pain drugs. A caudal nerve block (CNB) is a local anesthetic injected near the~     tailbone, in addition to general anesthesia, which can lower the need for pain drugs.~      The goal of this clinical research study is to learn how effective CNBs are in patients who~     are having penile prosthesis surgery compared to patients who only have general anesthesia by~     studying how long you stay in the hospital and the level of pain you have after surgery.~      This is an investigational study. The general anesthesia and CNB used in this study are FDA~     approved and commercially available. It is considered investigational to compare the~     effectiveness of CNBs in penile prosthesis surgery to general anesthesia alone. The study~     doctor can explain how the study drugs are designed to work.~      Up to 104 participants will be enrolled in this study. All will take part at MD Anderson.~   "
63165|NCT02740114|"~     Bupivacaine is a drug that is traditionally given as an injection to numb surgical sites.~     Liposomes are molecules that are similar to fats. Sometimes drugs are combined with liposomes~     to make them able to stay in the body for longer periods of time. This has been done with~     bupivacaine to create liposomal bupivacaine.~      The goal of this clinical research study is to compare the effects of bupivacaine to those of~     liposomal bupivacaine when given to patients who are having gynecologic surgery. Researchers~     want to compare how long the drugs work to numb the wound and how long patients take to~     recover from surgery.~   "
63166|NCT02740101|"~     To examine potential differential effects of receiving various social feedback on achieving~     personal goals,and whether oxytocin would modulate these effects.~   "
63167|NCT02740088|"~     This study aims to evaluate whether baseline 18F-sodium fluoride uptake activity at aortic~     valve could predict aortic stenosis progression in moderate aortic stenosis.~      Patients with moderate aortic stenosis are enrolled and underwent baseline evaluation~     including 18F-sodium fluoride PET/CT. After 1 year, all the participants underwent follow-up~     echocardiography. The study design is an observational trial. Primary endpoint was a change~     in mean pressure gradient along the aortic valve as assessed by echocardiography at 1 year.~     Secondary endpoints include changes in aortic valve area, and symptom occurrence.~   "
63168|NCT02740075|"~     After cardiac surgery patients are transported from the operating room (OR) to the intensive~     care unit (ICU) while intubated. Two principal methods of oxygenation and ventilation are~     used: (1) a transport ventilator or (2) a Mapleson Bag-Mask hand ventilating circuit. The~     choice of method is largely determined by the preference of the the anesthesiologist who is~     transporting the patient. The investigators postulate that the choice of either method might~     alter respiratory and hemodynamic parameters felt to be important for the immediate~     management of post-cardiac surgery patients. The investigators will prospectively record~     end-tidal carbon dioxide (ETCO2) (primary end-point) and change in minute volume, heart rate~     (HR), Blood pressure (BP), pulmonary artery (PA) pressures and cardiac output during~     transportation and upon arrival in the ICU. All of these variables are measured routinely but~     are not recorded. The investigators will compare patients transported with a ventilator to~     patients transported with a Mapleson circuit.~   "
63169|NCT02740062|"~     This trial is designed to preliminary evaluate the efficacy and safety of NIBS system for~     evaluation and treatment of neuropathic pain. The NIBS system evaluates brain neuronal~     network activity and customizes a personalized treatment utilizing low current non invasive~     brain stimulation technology for neuropathic pain with central component. this is single~     meeting trial which includes brain activity evaluation and a single treatment and sham~     treatment. The goal of the study is to evaluate the central brain component of neuropathic~     pain subjects, and the effect of conventional tDCS treatment.~   "
63170|NCT02740049|"~     Asthma is a long term disease of the lungs. In asthma patients the sensitive airway tubes~     narrow in reaction to something that irritates the airways such as allergens or environmental~     pollutants. There is currently no cure for asthma and new medicines or combinations of~     medicines are needed that will be of benefit to patients particularly those with a more~     severe disease.~      Activation of certain signal molecules inside the lung cells may participate in the~     development of asthma and the response to allergens. Blocking these signal molecules~     specifically with medicines might therefore be beneficial in the treatment of asthma. In this~     study we want to test a new medicine that specifically targets a subset of signal molecules~     that are associated with the allergen response in the lung. In particular, we want to test~     this medicine on cells obtained from the lungs of asthma patients. Understanding the effects~     of this new medicine on these asthmatic lung cells will give vital information on how this~     new medicine works before we can test it in asthma patients.~   "
63171|NCT02740036|"~     A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted~     on hard of hearing participants to grant quality control prior to product launch. The aim of~     the investigation series is to ensure zero-defect overall performance of the new hearing~     systems as well as maximum benefit for the participant with the devices in comparison to~     previously outstanding Phonak Hearing Systems and to equivalent competitor devices.~   "
63172|NCT02740023|"~     Phonak Hearing Systems pass through different development and study stages. At an early~     stage, feasibility studies are conducted to investigate new algorithms, features and~     functions in an isolated manner.~   "
63173|NCT02740010|"~     The purpose of this observational, non-controlled, multicenter trial with a retrospective~     design is to evaluate the visual performance of one cohort of patients who received the~     multifocal intraocular lenses (MIOL) MINI WELL® following refractive lens exchange (RLE) or~     cataract surgery. Primary outcome were: Uncorrected Distance Visual Acuity, Best Corrected~     Visual Acuity, Best Corrected Near Visual Acuity, onset of halos and glare (during night~     vision). It was also evaluated: Distance-Corrected Contrast sensitivity without glare,~     reading speed with the best correction for distance, and Defocus Curve under photopic~     conditions. ADE/SADE/USADE and AE/SAE were secondary outcomes.~   "
63174|NCT02739997|"~     This is a Phase 3, multi-site, non-randomized, open-label study evaluating the safety and~     efficacy of MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) plus metronidazole 500 mg for~     the treatment of Complicated Intra-abdominal Infections (cIAI) in Japanese participants.~     Efficacy will be primarily assessed by clinical response defined as complete resolution or~     significant improvement in signs and symptoms of the index infection.~   "
63175|NCT02739984|"~     The purpose of this study is to evaluate the effect of 12 weeks of subcutaneous evolocumab~     taken monthly compared with subcutaneous placebo taken monthly on low density lipoprotein~     cholesterol (LDL-C) in subjects with type 2 diabetes mellitus and high blood cholesterol on a~     maximally tolerated oral dose of statin of at least moderate-intensity.~   "
63176|NCT02739971|"~     The purpose of this study is to investigate whether dietary intake of pre-formed advanced~     glycation end products (AGEs) modulates brain function measured by MRI) and cognitive~     function measured by a thorough neuropsychological battery. In a 6 months randomized parallel~     study of adults above the age of 65, with mild cognitive impairment (MCI) and type 2~     diabetes. The investigators will compare two groups numbering 60 subjects each. Both groups~     will be advised on a diet appropriate for type 2 diabetes in the elderly by a nutritionist.~     In addition, the intervention group will be instructed on how to cook a low-AGE diet , with~     the aim of achieving a 40-50% lower AGE content, and they will be closely followed throughout~     the study to ensure compliance. Since diet is a modifiable lifestyle, diminishing AGEs~     consumption by cooking in lower temperatures (higher cooking temperatures being associated~     with higher AGE production) may be a simple non-invasive intervention which has potential of~     delaying or preventing cognitive decline which is associated with dementia.~   "
63177|NCT02739958|"~     The aim of this prospective, randomized clinical study is to compare between propofol and~     isoflurane on perioperative immune cell populations and function in patients undergoing total~     laryngectomy surgery.~   "
63178|NCT02739945|"~     The investigators want to compare changes in cross-sectional area (CSA) of the ulnar nerve at~     the elbow after open release or endoscopic release.~   "
63278|NCT02738645|"~     From 2003 when Severe Acute Respiratory Syndromes (SARS) appeared，many new types of~     respiratory viruses emerge in endlessly. Therefore, the epidemiology and the clinical~     character has changed quietly, especially severe pneumonia. This cohort study aim to obtain~     the contents of severe pneumonia patients in Respiratory Intensive Care Unit (RICU). Through~     the clinical data analysis, the investigators could get the information of the pneumonia~     caused by different reasons, such as morbidity and mortality, risk factors, clinical symptoms~     and radiographic changes, the respiratory support parameter and so on. The investigators hope~     the result could guide them do the clinical work of severe pneumonia better in the future.~   "
63179|NCT02739932|"~     The primary study aims are to determine the clinical, behavioural and social predictors of~     SMI development in youth, and to investigate whether neuroimaging can distinguish youth who~     will develop SMI from those who will not.~      The study's secondary aims are to examine the proportions of the cohort that make transitions~     between the different clinical stages of risk, and to determine the proportions that have~     poor outcomes, defined as ongoing or increased symptoms, secondary substance misuse, poor~     social or role functioning, i.e., non-participation in education, or employment, and new~     self-harm.~      Investigators will study a cohort of 240 youth (aged 14-25, male and female) that includes~     youth with early mood symptoms or sub-threshold psychotic symptoms (symptomatic group;~     n=160), youth at risk due to a family history of a SMI (family high risk (FHR); n=40), and~     healthy controls (HC; n=40). From this cohort, clinical, social and cognitive data, as well~     as imaging data will be gathered to create a multi-layered snapshot of these individuals~     and provide full-level characterization. Investigators will use the full range of clinical~     and imaging data generated from this cohort to develop novel prediction algorithms~     incorporating key variables that predict the development of SMI.~   "
63180|NCT02739919|"~     The aim of this research is to use a controlled laboratory setting to determine whether~     bacteria isolated from kidney stones of patients play a role in the formation of~     non-infectious kidney stones. It is well known that struvite stones are associated with~     active bacterial infection, however the role of bacteria in the formation of non-infection~     stones (like calcium oxalate) is not well characterized and there are theories that bacteria~     are involved in the making of these stones.~   "
63181|NCT02739906|"~     This is a 2 centres, randomised, double blind, three-treatment, three-period cross-over trial~     in subjects with type 1 diabetes mellitus.~      Each subject will be administered individualised single subcutaneous doses of BioChaperone~     Human Insulin (HinsBet®), insulin lispro (Humalog®) and regular human insulin (Huminsulin®~     Normal) immediately before ingesting a standardised mixed meal.~      Following trial drug administration, PK and PD assessments will be carried until 6 hours~     after start of the standardized test meal.~      The total trial duration for an individual subject will be up to 11 weeks.~   "
63182|NCT02739893|"~     The aim of this study is to see if use of ScopeGuide, as compared to the traditional~     colonoscope, improves successful completion of colonoscopy procedures as evaluated by ease of~     completion, time to completion, and reduction in the number of mechanical loops and external~     maneuvers required to advance the scope. Other outcome measures include looking at the amount~     of sedation required (independent of weight) and polyp rate detection.~   "
63183|NCT02739880|"~     The main objective of this study is to measure changes in the thickness of the vaginal lining~     (epithelium + underlying stroma) between 0 and 8 weeks after injection.~   "
63184|NCT02739867|"~     Among patients with a first episode of unprovoked venous thromboembolism (VTE), the~     contemporary one-year risk of detecting occult cancer is approximately 4% to 7%. Of these~     cases, 30% to 60% are missed by routine limited screening for cancer. RNA profiling of~     platelets is a promising, highly accurate biomarker for cancer detection, but its clinical~     utility in patients with unprovoked VTE is unknown. The objective of the present study is to~     evaluate the diagnostic accuracy of platelet RNA profiling in detecting occult cancer in~     patients with unprovoked venous thromboembolism. Secondary objectives include evaluation of~     other biomarkers for cancer, prediction of bleeding, and prediction of recurrent VTE.~   "
63185|NCT02739854|"~     The purpose of this study is to identify the prevalence rate and risk factors for pulmonary~     complications in patients with critical trauma who intubated and mechanical ventilation.~   "
63186|NCT02739841|"~     The purpose of this study is to explore acute hemodynamic responses to VHI technique in~     critical traumatic patients with pulmonary complications in the intensive care unit.~   "
63187|NCT02739828|"~     The objective of this study is to assess quality of life (QoL), skin pain, work~     productivity/activity and health related problems in Swedish patients with moderate to severe~     HS before and after 6 months treatment with Adalimumab. The patients will be treated in~     accordance with normal routine clinical care.~   "
63188|NCT02739815|"~     This study aims to define a safe prophylactic intravenous TXA dose with an advantage over~     others in reducing total blood loss volume at secondary uncomplicated LSCS.~   "
63189|NCT02739802|"~     To evaluate the Sun Protection Factor (SPF) efficacy on human skin.~   "
63190|NCT02739789|"~     This research study identifies neural pathways regulating negative moods during rejection by~     combining transcranial direct current stimulation (tDCS) and fMRI in a sample of healthy~     controls.~   "
63191|NCT02739776|"~     The purpose of this study is to describe infrared thermographic imaging as a tool for the~     assessment of epidural block in obstetrics patients~   "
63192|NCT02739763|"~     The investigators wish to understand how resistance to malaria develops and how this affects~     the growth rate of malaria in individuals who have past exposure to malaria.~   "
63193|NCT02739750|"~     Chronic Kidney Disease (CKD) is associated with bone changes and very high fracture rates. A~     component of bone is marrow. Bone marrow fat is increased in patients with CKD compared to~     those in the normal population of the same age. It is not clear if there will be changes in~     the marrow fact content in those with CKD on Pioglitazone. In people with normal kidney~     function, thiazolidinedione group of drugs have had variable effects on bone marrow fat~     content, as measured by MRS. This is important as changes in marrow fat are likely related to~     changes in the bone in patients with chronic kidney disease.~   "
63194|NCT02739737|"~     No consensus exists among biomedical journals on the subject of blinding during the peer~     review process. Some journals attempt to remove all identifiers of authorship from potential~     manuscripts before delivering to referees for peer review while others prefer to leave the~     authorship transparent. Although peer review remains the gold standard for manuscript~     evaluation, the lack of a standardized blinding process between editorial offices may be a~     source of publication bias and make comparisons of manuscripts published in different~     journals more difficult to interpret.~      Proponents of a blinded peer review system believe that knowledge of authorship may leave~     referees vulnerable to biases about those authors' previous research, perceived expertise,~     institution, nationality, or gender. This shifts judgment away from the merits of the~     scientific work and introduces pre-conceived notions about the identity and background of the~     author into the review process. Conversely, supporters of transparent authorship argue that~     knowledge of author identity makes it easier for the referee to provide more appropriate~     critiques. Open author identification allows referees to compare the current manuscript to~     previously published work by the author, and to recognize or identify potentially important~     conflicts of interest.~      The investigators therefore propose an experimental study to address the question of whether~     blinding affects the likelihood a reviewer will recommend acceptance of a study being peer~     reviewed. The investigators plan to work in partnership with a journal to have a fabricated~     manuscript peer reviewed by a large number of reviewers; the authors will send this test~     manuscript out either in blinded form (authors' names/institutions not shown to reviewers) or~     in open form, with the names of several well-known, well-regarded authors and their~     institutions visible to peer reviewers. The manuscripts will otherwise be identical.~      The partnering journal, Clinical Orthopaedics and Related Research allows both open and~     blinded peer review, regularly employing both approaches (authors can choose what kind of~     review they prefer when they submit to CORR), and so the reviewers are unlikely to be~     troubled by seeing a manuscript in either format.~      The primary goal of this study is to determine whether the identification of a manuscript~     with a prominent group of authors (open authorship) will affect the likelihood that reviewers~     will recommend the manuscript for publication.~      Additionally, the investigators plan to purposely place several errors in the manuscript, and~     tally how often reviewers detect these mistakes, to determine whether reviewers read the work~     of prominent authors less critically.~      The investigators will also compare the reviewers' grading of the (identical) methods~     section, to determine whether the identification of a manuscript with prominent authors~     results in higher reviewer grades for methodological rigor.~      This study tests the following specific hypotheses:~        1. The visibility of prominent author names and institutions on test manuscripts will be~          associated with increased likelihood that the manuscript will be recommended for~          publication by peer reviewers. (Primary Study Endpoint)~        2. The visibility of prominent author names and institutions will be associated with a~          decreased likelihood that purposefully placed errors in the experimental manuscript~          will be detected by the reviewers.~        3. The visibility of prominent author names and institutions will be associated with~          increased scores given by reviewers for the methods section, despite the fact that the~          methods sections of the experimental manuscript will be identical.~      NOTE:~      All elements of the research protocol were approved by the University of Washington Human~     Subjects Review Committee, including the study's opt-out design for reviewer recruitment,~     since it was considered important that reviewers not know that the paper they evaluated was~     part of a study. To minimize the potential for harm, the authors chose as the topic of the~     fabricated test manuscript an intervention that could not be immediately put into practice at~     reviewers' own centers (a particular team-training process in the operating room). In~     addition, participating reviewers were informed which paper was the test manuscript at the~     completion of data collection, so that they did not pursue this sort of team training based~     on the results of the fabricated study.~      To reduce the risk of an observer (Hawthorne) effect, it was important to minimize the~     likelihood that participant reviewers would learn of the study while it was in progress. To~     this end, the investigators elected not to pre-register the study in a trial registry.~   "
63208|NCT02739555|"~     Osteoid osteoma (OO) is a benign osteogenic tumor occurring in children and young adults,~     responsible for intense bone pain, which has a tendency to spontaneously heal with~     mineralization of the nidus, but extremely slowly. This healing may be accelerated in~     patients taking NSAIDs regularly during a few years. The long delay for healing and intense~     pain, explain why patients are quickly directed to surgeons or specialized radiology~     departments for tumor ablation. But percutaneous treatment or surgical excision destruction~     can expose the patient to a substantial risk in terms of neurologic or joint damages,~     depending on the location. Bisphosphonates treatment may be an effective alternative to~     percutaneous treatment by accelerating the natural history of OO.~   "
63195|NCT02739724|"~     Introduction~      Single port access (SPA) is a recent laparoscopic technic evaluated in several pathologies.~     Benefits of this technic is poorly reported concerning adnexal surgical procedures. Results~     of both randomised studies including adnexectomy and ovarian cystectomy are discordants. So~     it seems interesting to conduct a new study about this technic. Aim of this study is to~     compare postoperative pain after laparoscopic surgery for adnexal pathology by SPA or classic~     laparoscopy (CL).~      Materiel and Methods~      We purpose a monocentric-randomised study. Inclusion criteria are women over 18 years~     requiring laparoscopic surgery for adnexal pathology with stratification for procedure~     (adnexectomy or ovarian cystectomy). After informed consent, patients will be randomised in~     two groups: laparoscopy with SPA and laparoscopy with CL. The main objective is postoperative~     pain evaluation at 24 hours. Secondary objectives are characteristics and perioperative~     complications, duration of procedure, postoperative quality of life and immediate~     postoperative pain.~      We hypothesis laparoscopy with SPA reduces postoperative pain at 24 hours of 2 pts (analogic~     scale 0-10). The estimated size of population number is 54 per group and 108 for the study.~      Expected results~      We expected a significant decrease of postoperative pain with SPA technic. This data will be~     interesting to promote use of SPA technic for adnexal surgery.~   "
63196|NCT02739711|"~     Aim of the study is to examine the effects of glycoprotein IIb/IIIa inhibitors on reperfusion~     success assessed by cardiac magnetic resonance imaging in patients with myocardial infarction~     and angiographic evidence of no-reflow.~   "
63197|NCT02739698|"~     A randomized controlled single-blind clinical trial was performed, in 32 patients diagnosed~     with peritoneal carcinomatosis from epithelial ovarian cancer, who underwent radical~     surgery-peritonectomy, achieving an optimal R0-R1 cytoreduction (microscopic tumor residues~     (R0) or macroscopic tumor residues < 1cm (R1)) followed by hyperthermia against normothermia~     intraperitoneal intraoperative chemotherapy with paclitaxel~   "
63198|NCT02739685|"~     The purpose of the current study is to demonstrate non-inferiority of everolimus-eluting~     bioresorbable vascular scaffold to everolimus-eluting stents in patients with chronic total~     occlusion regarding the antirestenotic efficacy at 8 to 10-month angiographic follow-up.~   "
63199|NCT02739672|"~     randomized, open-label, single dose, replicate crossover clinical trial to compare the~     pharmacokinetics of TAH tablet in comparison to the co-administration of telmisartan,~     amlodipine and hydrochlorothiazide in healthy male volunteers~   "
63200|NCT02739659|"~     The aim of this research project is to assess the feasibility and safety of carbon-ion~     radiotherapy (CIRT) for the treatment of in Chinese localized prostate cancer~   "
63201|NCT02739646|"~     Rationale: The representation of the breast on the somatosensory cortex has not been~     precisely located. Therefore, a pilot study with healthy subjects is needed to localize the~     sensibility of the breast on the somatosensory cortex with the use of a 7 Tesla fMRI.~      Objective: To determine the exact localization of the representation of the sensibility of~     the breast and nipple-areola complex on the somatosensory cortex. Secondly, to assess whether~     there are differences in representation between individuals of the same sex and between both~     sexes.~      Study design: A single center pilot study carried out in the Maastricht University Medical~     Center, the Netherlands.~      Study population: A total of 10 female and 10 male healthy individuals will be recruited.~      Intervention: Every subject will undergo a functional MRI scan with stimulators applied to~     the bare breast in a fixed pattern. These stimulate the skin and sensory nerves of the breast~     and nipple-areola complex in a random sequence.~      Main study parameters: The hemodynamic response after stimulation of the skin of the breast~     and nipple-areola complex, representing neuronal activity in that region, is measured. Within~     the somatosensory cortex (S1 and S2), the temporo-spatial brain activity patterns after the~     various stimulation conditions are assessed, and the representation of the breast on the~     somatosensory cortex is mapped.~   "
63202|NCT02739633|"~     Phase II Study of Weekly Genexol®-PM Plus Gemcitabine in Subjects With Recurrent and~     Metastatic Adenocarcinoma of the Pancreas.~   "
63203|NCT02739620|"~     Exercise training has beneficial effects in cancer survivors to minimize some of the side~     effects of cancer and its treatment and improve long-term prognosis, but there are numerous~     hurdles for individuals diagnosed with, and being treated for, cancer to participate in~     exercise programs. The goal of this research study is to begin to evaluate whether exercise~     training via neuromuscular electrical stimulation (NMES) has beneficial effects on skeletal~     muscle size and function in cancer survivors.~   "
63204|NCT02739607|"~     Objectives~        1. To test the effectiveness and acceptability of an augmented internet-supported~          transdiagnostic intervention in Romania.~        2. To assess the cost-effectiveness of the Internet version of the transdiagnostic program~          as compared to a standard treatment/usual care.~   "
63205|NCT02739594|"~     This multicenter, open-label trial will randomize participants with multiple myeloma to a~     regimen of ibandronate or zoledronate in order to compare the incidence of nephrotoxicity,~     measured as creatinine clearance (CrCl) reduction greater than (>) 30 percent (%) or an~     absolute value of 30 milliliters per minute (mL/min) or lower.~   "
63206|NCT02739581|"~     The patients will be randomized into two groups~        1. Endoscopic Variceal Ligation with Non Selective Beta Blocker~        2. Placebo with Endoscopic Variceal Ligation~   "
63207|NCT02739568|"~     The first objective of this study is to demonstrate the efficacy and safety of pitolisant~     given at 10, 20, or 40 mg per day versus placebo during 12 weeks of the Double Blind period,~     to treat the Excessive Daytime Sleepiness (EDS) in patients with Obstructive Sleep Apnea~     (OSA) refusing the nasal Continuous Positive Airway Pressure (nCPAP) therapy or treated by~     nCPAP but still complaining of EDS.~      The secondary objectives of the study include assessing the long-term tolerance as well as~     the maintenance of efficacy of pitolisant given at 10, 20 or 40 mg per day during 39 weeks of~     Open Label Extension period and further investigating the co-variates or co-medications that~     affect the pharmacokinetics of pitolisant in the target population.~   "
63209|NCT02739542|"~     The purpose of this investigation is to systematically study the efficacy of Tecfidera in~     those individuals who possess incidental white matter anomalies within the brain following a~     MRI study that is performed for a reason other than for the evaluation of MS (multiple~     sclerosis).~   "
63210|NCT02739529|"~     Dose-dense paclitaxel (Genexol®-PM) once a week in combination with carboplatin every 3 weeks~     for gynecologic cancer (adult solid tumor): a phase I trial.~   "
63216|NCT02739451|"~     Acute respiratory failure (ARF) is the leading reason for ICU admission in immunocompromised~     patients. Usual oxygen therapy involves administering low-to-medium oxygen flows through a~     nasal cannula or mask [with or without a bag and with or without the Venturi system] to~     achieve SpO2≥95%.~      Oxygen therapy may be combined with non-invasive ventilation [NIV] providing both~     end-expiratory positive pressure and pressure support. However, in a recent trial by our~     group, non-invasive ventialtion [NIV] was not superior over oxygen without NIV.~      High-flow nasal oxygen [HFNO] therapy is a focus of growing attention as an alternative to~     standard oxygen therapy. By providing warmed and humidified gas, HFNO allows the delivery of~     higher flow rates [of up to 60 L/min] via nasal cannula devices, with Fraction of inspired~     oxygen (FiO2) values of nearly 100%. Physiological benefits of HFNO consist of higher and~     constant FiO2 values, decreased work of breathing, nasopharyngeal washout leading to improved~     breathing-effort efficiency, and higher positive airway pressures associated with better lung~     recruitment.~      Clinical consequences of these physiological benefits include alleviation of dyspnoea and~     discomfort, decreases in tachypnoea and signs of respiratory distress, a diminished need for~     intubation in patients with severe hypoxemia, and decreased mortality in unselected patients~     with acute hypoxemic respiratory failure However, although preliminary data establish the~     feasibility and safety of this technique, HFNO has never been properly evaluated in~     immunocompromised patients.~      Thus, this project aims at demonstrating that HFNO is superior to low/medium-flow (standard)~     oxygen, minimising day-28 mortality~   "
63217|NCT02739438|"~     The carry out a prospective cohort study of healthy volunteers, assessing differences between~     baseline pulmonary inflammation, response to LPS inhalation and endothelial function, as~     measured by flow mediated dilation between, electronic cigarette uses, cigarette smokers and~     non smokers.~   "
63218|NCT02739425|"~     The aim of this study is to evaluate the Sentimag/Sienna+ System (Sentimag®) in clinical~     routine practice. On the one hand this allows evaluation of the equivalence of the two~     techniques. On the other hand this ensures that patients do not experience any possible~     disadvantages by participating. The hypothesis behind this evaluation is that Sentimag is as~     efficient as conventional sentinel node mapping.~      The programme will compare the Sentimag® with the conventional sentinel lymph node detection~     with radioactive tracer combined with blue dye (in centres using the combined technique) and~     thereby determine whether the new technique is equivalent to the standard technique for SLNB.~   "
63219|NCT02739412|"~     A common complication of organ transplantation is 'rejection' of the transplanted organ. This~     occurs when the body's immune system tries to attack (or reject) the transplanted organ.~      Drugs known as immunosuppressants (anti-rejection medications) are prescribed for patients~     after transplantation to prevent rejection. But, anti-rejection medications are associated~     with significant side effects including high blood pressure, high blood sugars, and high~     cholesterol - all of which may increase the risk of heart and vascular complications.~     Anti-rejection medications also increase the long-term risk of some types of cancer.~      Sometimes, liver transplant patients who stop taking anti-rejection medications do not~     experience rejection of their transplanted liver and the liver keeps working. These patients~     are said to tolerate the transplanted liver, and this condition is referred to as~     tolerance. Doctors are working to learn more about why some liver transplant patients~     develop tolerance after receiving a transplant, while others do not.~      Studies have shown that patients who develop tolerance have an increase in a type of immune~     cell called regulatory T-cells or Tregs. This means Tregs may be important in preventing~     rejection of a transplanted organ.~      Studies have also shown that a human cytokine (a type of protein), called interleukin-2~     (IL-2) aids in increasing the number of Treg cells in the body, and IL-2 has been given to~     patients to successfully treat disorders of the immune system such as graft vs host disease -~     a serious condition sometimes seen in patients after bone marrow transplantation.~      The purpose of this investigation is to study if low dose IL-2, given to liver transplant~     patients by subcutaneous (under the skin) injections, over a 4 week period of time, will~     cause an increase in the number of Treg cells in the blood.~      In addition, investigators will learn about the kinds of side effects low dose IL-2 will~     cause and how severe those side effects will be.~   "
63220|NCT02739399|"~     In patients under general anesthesia, episodes of hypotension are often treated with~     phenylephrine. The effect of phenylephrine is conventionally attributed to afterload~     increase.~      The aim of the study is to describe the time course of the effects of phenylephrine on the~     cardiac preload and cardiac output, and to evaluate whether phenylephrine, as an exclusive~     alpha-mimetic, could be beneficial for preload optimisation.~   "
63221|NCT02739386|"~     The research questions to be addressed by this study are as follows:~        1. What is the prevalence of ipilimumab use among adults with a history of autoimmune~          disease that received treatment with ipilimumab for advanced melanoma?~        2. Do melanoma patients with a history of autoimmune disease experience complications that~          require hospitalization related to their underlying autoimmune disease following~          treatment with ipilimumab?~   "
63222|NCT02739373|"~     The main purpose of this study is to measure the amount of study drug (BMS-986189) in the~     blood and urine and to see if BMS-986189 is safe and well-tolerated in healthy people after a~     single dose.~   "
63223|NCT02739360|"~     This study is to provide idelalisib to participants receiving GS-9820 in Gilead-sponsored~     Study GS-US-315-0102 at the time of study closure.~   "
63224|NCT02739347|"~     This study proposes to assess the effect of trans-cranial direct current stimulation (tDCS)~     on cognitive control, working memory, functional, clinical, and cognitive outcomes in~     schizophrenia patients.~   "
63225|NCT02739334|"~     The purpose of this study is to learn whether a combination of two research-proven programs,~     a responsive caregiving parenting program and a childhood obesity prevention program, will~     have an effect on toddlers' healthy nutrition and physical activity behaviors. Investigators~     hypothesize that the children participating in the intervention will have significantly lower~     BMI z-scores, lower intake of sugar sweetened beverages, and increased number of servings of~     fruits and vegetables, and minutes of physical activity.~   "
63266|NCT02738801|"~     A multicenter randomized, double-blind, parallel group, placebo-controlled, exploratory phase~     IIa study in subjects with Idiopathic Pulmonary Fibrosis (IPF) to evaluate safety,~     tolerability, PK and PD of GLPG1690. Male and female subjects aged 40 years or older will be~     screened to determine eligibility. The screening period will be up to 4 weeks. At baseline,~     eligible subjects will be randomized in a 3:1 ratio to GLPG1690 or matching placebo~     administered for 12 weeks. The subjects will visit the study center at screening, baseline,~     week 1, 2, 4, 8 and 12 and for a follow up visit 2 weeks after the last administration of~     study drug. Planned assessments: Adverse event reporting, clinical laboratory tests, vital~     signs, physical examination, 12-Lead-ECG, PK blood sampling, biomarker blood/BALF samples,~     Spirometry, St George's respiratory questionnaire, high-resolution computed tomography~     (HRCT).~   "
65908|NCT02704325|"~     The proposed clinical trial study of rAAVrh74.MCK.GALGT2 for duchenne muscular dystrophy~     (DMD) patients that will involve direct intramuscular injection to the extensor digitorum~     brevis muscle (EDB).~   "
63226|NCT02739321|"~     The purpose of the present study is to evaluate the tolerability and efficacy of the Sound To~     Sleep System™ in improving the sleep quality of children with Autism Spectrum Disorder (ASD).~     The Sound To Sleep System™ is a mattress foundation designed to improve sleep quality in~     individuals with ASD and sleep disturbance by providing mattress vibrations that accompany~     and sync with auditory stimulation. For the present study, the primary objectives are as~     follows:~      * Study Aim 1 - To determine whether the use of the Sound To Sleep System™ in ASD-affected~     children with sleep disturbances is well tolerated as defined by group drop-out proportion~     due to issues with the mattress technology.~      The study will also explore the following objectives:~        -  Study Aim 2 - To determine the efficacy of the Sound To Sleep System™ in improving sleep~          quality as measured by parent reported sleep quality in ASD-affected children with sleep~          disturbances. (Please note Study Aim 2 was changed from clinician-rated to parent-rated~          because we were not able to collect clinician-rated sleep quality information).~        -  Study Aim 3 - To determine the tolerability of the Sound To Sleep System™ as defined by~          study drop-out due to any reason and caregiver ratings of ease of mattress technology~          use.~        -  Study Aim 4 - To determine whether use of the mattress technology improves functioning~          as defined by secondary outcome measures.~   "
63227|NCT02739308|"~     The aim of this study is to investigate the influence of a 12-week proprioceptive training~     program on the neurofunctional control and the incidence of ankle sprains in fencing~     athletes. The study will be developed in six stages: familiarization, pre intervention,~     intervention, post intervention follow-up of three and six months. In the pre intervention~     stage will evaluate muscle strength inverters, everter, dorsal plantar flexors and ankle~     flexors through the isokinetic dynamometer; the reaction time of these muscles during Lunge~     Test; neuromuscular control during the Star Excursion Balance Test and performance in Drop~     Vertical Jump Test. In the intervention athletes will perform proprioceptive training for 12~     weeks, three times a week, lasting 30 minutes. In the post intervention, the follow up of~     three to six months will be held the same pre intervention of the tests and recording the~     incidence of injuries occurred during the study. The expected result at the end of the study~     is to improve all variables, increasing the performance of athletes and decreasing the~     incidence of ankle sprains.~   "
63228|NCT02739295|"~     NeupoNET aims to evaluate interest of G-CSF in the treatment of Toxic Epidermal necrolysis.~     This is a prospective randomized controlled trial.~      Patients will be allocated in a treatment group (receiving an injection of 5 microg/kg/d of~     G-CSF during 5 consecutive days) or in a placebo group. Patients will be randomized at~     admission and will be followed until 3 months after discharge.~   "
63229|NCT02739282|"~     The investigators aim at studying therapeutic drug monitoring of newer generation~     antiepileptic drugs (AEDs) in people with epilepsy, using state of the art Ultra-performance~     Liquid Chromatography coupled to Tandem Mass Spectrometry:~        -  to assess the tangible benefit of individualising therapy through therapeutic drug~          monitoring in term of clinical response and adverse events~        -  to assess the reliability and added value of salivary therapeutic drug monitoring This~          will be assessed through a randomised trial of either systematic or rescue therapeutic~          drug monitoring in people requiring treatment adjustment; outcome will be assessed in~          term of tolerance and treatment response in a survival analysis to assess the benefit of~          systematic therapeutic drug monitoring. For each blood samples taken in those studies, a~          saliva probe will be collected and its reliability ascertained retrospectively.~   "
63230|NCT02739269|"~     This is a prospective randomized trial to compare the use of AFC and serum AMH as the basis~     for gonadotrophin dosing in in-vitro fertilization treatment.~      The hypothesis is that the use of serum AMH as the criterion for determination of~     gonadotrophin dosing in IVF treatment results in more optimal ovarian response than AFC.~   "
63231|NCT02739256|"~     The primary aim of this study is to determine if normal bladder function (the ability to~     empty the bladder during spontaneous urination) after surgical repair of pelvic organ~     prolapse returns faster in patients who have a retrograde voiding trial the day of surgery~     versus patients who have a retrograde voiding trial on postoperative day one. Half of~     participants will have a voiding trial 4 hours after surgery, while the other half will have~     the voiding trial postoperative day one.~   "
63232|NCT02739243|"~     Background and study aims: Being a caregiver for someone with cancer can be very difficult~     emotionally. For many the patient is a family member or friend, and so this can cause the~     caregiver a great deal of psychological distress. There are currently very few studies~     looking into the effectiveness of psychological treatments for distressed caregivers of~     cancer patients. This study is looking at tailored group therapy program for carers of cancer~     givers. The aim of this study is to find out whether this program can help to lower levels of~     distress in cancer caregivers and help them to better cope with caring for someone with the~     illness.~   "
63233|NCT02739230|"~     The goal of this research project is to evaluate the effectiveness of a novel treatment to~     control pain after Total Knee Arthroplasty (TKA). The proposed approach to manage pain and~     eliminate risks associated with catheters is the use of Exparel injection into the joint at~     the time of surgery.~   "
63234|NCT02739217|"~     This is a Phase 2, single-centre, single-arm, open-label study of the safety, tolerability,~     and effects on biomarkers of PBI-4050 in subjects with Alström syndrome for a treatment~     duration of 24 weeks.~      Subjects who complete the initial 24 weeks of treatment may continue treatment for an~     additional 36 or 48 weeks, provided the subject signs informed consent.~   "
63235|NCT02739204|"~     The research and development of novel anti-tumor agents in oral cancer is slow, the~     investigation of repositioning use of currently available drugs in clinical, such as a~     selective cyclooxygenase-2 (COX-2) inhibitor (Celebrex/Celecoxib) maybe a potential~     alternative strategy.~   "
63236|NCT02739191|"~     Prophylactic use of Negative Pressure Wound Therapy (NPWT) on surgical wounds following lower~     extremity orthopedic trauma to prevent infectious complications.~   "
63237|NCT02739178|"~     The study will measure the impact of sanitation access on women and girl's social and~     emotional health, behaviors, and quality of life in rural India before and after a sanitation~     intervention compared to a comparison group that will receive the same intervention at a~     later date.~   "
65909|NCT02704312|"~     Compare dosimeters in both positions (prone and decubitus) for each patient~   "
63239|NCT02739152|"~     Sepsis is a serious systemic disease defined as a combination of Systemic Inflammation~     Response Syndrome (SIRS) plus a confirmed or suspected infection. Untreated or inadequately~     treated cases can lead to severe sepsis or septic shock; being characterized by high~     mortality and morbidity.~      Symptoms and signs of sepsis are variable and this makes clinical recognition and assessment~     very difficult in particular on Emergency Department (ED) patients due to their infectious~     illness background and the frequent comorbidities. Also, the severity of the condition may~     not be apparent at initial contact with ED personnel: patients may arrive at ED with mild~     clinical manifestation and rapidly progress to critical illness, or rather at the opposite~     others have benign evolution despite a similar symptoms. In these conditions, the main~     challenge of ED clinicians is differentiating mild infections from life-threatening ones in~     the heavy workload of ED environment Objective of TRIAGE project is to identify and validate~     biomarkers able to predict the clinical worsening of patients freshly admitted at Emergency~     Department.~      Targeted population is adult patients freshly admitted at ED, whom blood samples will serve~     to validate candidate markers.~   "
63240|NCT02739139|"~     The manufacturers of AlphaBRAIN(TM) claim that their product, when taken as directed, has~     beneficial effects on cognition. The active ingredient in AlphaBRAIN, Huperzine A, is a~     naturally occurring compound found in firmoss and also thought to be an acetylcholinesterase~     inhibitor. Numerous clinical studies have been undertaken to investigate the effects of~     Huperzine A on cognition and have demonstrated benefit to cognition in both individuals~     diagnosed with neurodegenerative diseases as well as performance on academic tasks by~     students. However, to our knowledge, there are no randomized controlled trials evaluating the~     effects of AlphaBRAIN(TM) on cognition. Thus, the purpose of the current study is to assess~     the effects of daily oral administration of AlphaBRAIN(TM) on cognitive functioning, as~     compared to placebo, after 45 days of treatment.~        1. To evaluate a single daily dose of AlphaBRAIN(TM) vs placebo given orally on the change~          in a battery of standardized neuropsychological tests (see attached).~        2. A secondary objective is to evaluate a single daily dose of AlphaBRAIN(TM) vs placebo~          given orally on sleep.~   "
63241|NCT02739126|"~     Obtaining a tissue sample to diagnose parenchymal lung lesions (PPL) suspected of cancerous~     origin is of utmost importance. Due to it's markedly favourable safety profile, a~     bronchoscopic biopsy method called Radial EBUS is becoming increasingly popular. However, a~     meta-analysis reports the success rate of Radial EBUS in diagnosis is 73%, which in~     comparison to CT guided biopsy which is the gold standard in diagnosing PPL (90% success~     rate), is sub-optimal.~      There are 2 types of USS probes used in the R-EBUS procedure. Whilst the thicker USS probe~     (1.7mm) is capable of accommodating larger biopsy instruments, the thinner USS probe could be~     advanced more peripherally to obtain a biopsy.~      Therefore identifying what type of USS probe is better for a given PPL will aid in improving~     the diagnostic yield.~      In this study, investigators compare these two types of probes in the ability to diagnose a~     PPL.~      The biopsy instruments used for both arms are forceps and cytology brush. For the thick USS~     arm, in addition, an aspiration needle will also be used. (The thin USS guide sheath is too~     small to accommodate an aspiration needle)~   "
63242|NCT02739113|"~     Earlier protocol for cultivated oral mucosal epithelial transplantation (COMET) requires~     trypsin/EDTA to isolate epithelial cells from tissue, and uses murine 3T3 cells as feeder~     cells, which results in biosafety concern. This study uses collagenase instead of~     trypsin/EDTA to isolate epithelial cells, and does not use 3T3 cells co-culture, so as to~     make an animal ingredient-free cell culture product. The purpose of the study is to evaluate~     the feasibility of the new protocol of COMET in clinical use.~   "
63243|NCT02739100|"~     The main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered via~     hemodialysate and via two different intravenous routes in adult patients with chronic kidney~     disease on chronic hemodialysis (CKD-5HD). It is an open-label, randomized single dose study.~   "
63244|NCT02739087|"~     Currently catheters used in heart catheterization procedures are guided throughout the heart~     chambers and blood vessels by pictures taken by x-rays. This technology exposes patients to~     radiation. With this study protocol the investigators will use MRI technology to take~     real-time pictures to navigate catheters throughout heart chambers. MRI uses electromagnetic~     energy; therefore, it does not expose participants to radiation energy.~   "
63245|NCT02739074|"~     Endoscopic treatment of pancreatic necrosis complicated by trans digestive track (duodenal or~     gastric) has become a standard technique validated. The rate of high technical and clinical~     success (76 to 91% in 3 months) and the lower morbidity in the literature explains that~     validation. However this treatment is done at the cost of a higher median number of treatment~     sessions (4-5) explaining prolonged hospitalization, delays in rehabilitation and potentially~     high costs. The constant improvement of therapeutic endoscopy equipment was allowed to see~     the advent of metal prosthesis completely covered by a membrane allowing them endoscopic~     extraction with ease. It has thus been recently developed short prostheses, of large diameter~     (up to 15/16 mm), with broad flange (or stent diabolo) to be considered for use in the~     drainage of digestive peri collections. Few studies respectively determined the effectiveness~     of this type of prosthesis in the drainage of peri digestive collections Under echo endoscopy~     and treatment of necrosis of pancreatic origin. The purpose of this work is to evaluate~     multicenter prospective clinical and technical efficiency of laying completely covered stent~     diabolo in echo endoscopy for the treatment of necrosis of pancreatic origin.~   "
63267|NCT02738788|"~     The goal of this study is to track the intraoperative changes that occur in the airways of~     patients undergoing 1) laparoscopic surgeries in the Trendelenburg position, and 2) spinal~     surgeries in the prone position, as well as the regression of these changes postoperatively.~     These surgeries are known to cause edema and swelling of the soft tissues of the head and~     neck, temporarily worsening airway anatomy, but there is little data quantifying these~     changes, and no studies have investigated the time course required for the airway to return~     to its baseline after extubation. This would be important clinical information given that~     airway management is always a major concern perioperatively. The investigators will test~     hypotheses by evaluating patients' airways preoperatively, immediately post-extubation, and~     at regular intervals thereafter using the Modified Mallampati Score class (MMS), in which a~     patient's airway is scored from class 1 to 4 (in which 4 indicates the highest likelihood of~     a difficult intubation) based on the visibility of the soft palate, uvula, and faucial~     pillars inside the oral cavity.~   "
63246|NCT02739061|"~     This study intends to explore the pathogenesis of obsessive-compulsive disorder(OCD) by using~     biological technologies such as genetics and imaging, and to evaluate the efficacy of group~     cognitive behavioural therapy in OCD among the Chinese people. We also prepare to explore the~     synergistic effect of the pharmacological treatment combined with group cognitive behavioural~     therapy in OCD, and to find the biological and psychological index which can predict curative~     effect.~      This research includes case control study and randomized controlled single-blind study. At~     baseline, we compare the dimensions of clinical symptoms, genetics and imaging between OCD~     patients and healthy controls. The OCD patients are randomly assigned into pharmacological~     treatment, psychological treatment or pharmacological combined with psychological treatment~     for a 12-week treatment. After a 12-week treatment, the OCD patients will be divided into~     valid and invalid groups according to the results of our randomized controlled study by~     researchers: to our valid group, patients will continue the current treatment, and to the~     invalid psychological or pharmacological treatment group, patients will have a 12-week~     combined treatment. From the baseline, we will have a 9-month follow up for both OCD patients~     and healthy controls.~   "
63247|NCT02739048|"~     1. The overall objective of the study: By evaluating the curative effect of CSAP in localized~     prostate cancer, locally advanced prostate cancer and metastasis advanced prostate cancer,~     and the change of state in cellular immunity and humoral immunity before and after CSAP.~     Validate the clinical therapeutic effect of all kinds of prostate cancer, as well as the~     change of immune status before and after CSAP.~      2. The main content of the study:~        1. Included in the samples are patients in hospitals for CSAP. The sample capacity are~          planned to be 80. The main purpose of the study is to observe the overall survival rate~          , disease free survival rate, the progress time of the PSA biochemical recurrence as~          well as the disease progress time.~        2. Measure the change of concentration in peripheral blood T lymphocyte subsets (CD3 + T,~          CD4 + T, CD8 + T, CD4 + / CD8 + T, NK cells) and regulatory T cells before and after~          cryoablation within 1 month, 3 months and 6 months.~        3. Measure the change of concentration in peripheral blood IFN-1, IL-4, IFN-1/IL-4 ratio~          (Thl/Th2 ratio), and detect the secretion of CD4 + Th tumor-specific IFN-l and the~          activity of tumor-specific killer CD8 + CTL before and after cryoablation within 2 weeks~          and 1 month.~        4. Before cryoablation, detect the expression and distribution of Follistatin-Like1~          (FSTL-1), Besides, verify the connection between the number and activation ratio of~          tumor local dendritic cells (DC) and the FSTL-1, evaluating the cryoablation effect on~          the immune response.~   "
63248|NCT02739035|"~     Compare the outcome following manipulation under anesthesia for stiffness in a randomized~     controlled fashion with one group receiving IV dexamethasone and oral celecoxib at the time~     of manipulation to a control group receiving manipulation alone.~      Outcomes will include pain, range of motion, as well as subjective outcome scores.~   "
63249|NCT02739022|"~     This is a pilot study designed to test feasibility of a psychotherapeutic intervention for~     the critically ill patients in intensive care units. Intervention is named Early~     Psychological Support for the Critically Ill (EPSCI)~   "
63250|NCT02739009|"~     This is a randomized, double-blind, placebo-controlled, dose-escalation, phase I study for~     the assessment of safety, tolerability and pharmacokinetics of single ascending doses of~     MOR106 in healthy male subjects and multiple ascending doses in subjects with moderate to~     severe atopic dermatitis.~   "
63251|NCT02738996|"~     Type-2 diabetes, a common non-infectious disease, is the result of impaired insulin function~     and insulin production in the body. In type-2 diabetic patients, postprandial glucose~     control, lipid control and reduction of insulin resistance are crucial to deter the~     development of diabetes related complications (e.g. retinopathy, nephropathy, neuropathy and~     cardiovascular diseases), pancreatic β cells failure, morbidity and mortality. Currently,~     diet, exercise and standard oral medicines are used to treat type-2 diabetes. However,~     providing the most effective treatment to control postprandial glucose and lipid; and to~     preserve the pancreatic β cells is challenging because poor metabolic profiles are still~     detected in type-2 diabetic patients. Therefore, understanding the factors influencing the~     poor metabolic profiles and adjunct therapy to manage type-2 diabetes are really important to~     tackle this disease.~      In modern society, people are spending most of their waking time in sedentary behaviour,~     which is primarily prolonged sitting. Prolonged sedentary time is associated with increased~     postprandial glucose, lipid and insulin resistance. In contrast, frequent interruption of~     prolonged sitting with short light activity break reduces postprandial glucose, triglyceride~     cholesterol and insulin resistance. However, how frequently patients should interrupt~     sitting, potential longer-term effect of short activity break on reduction of postprandial~     glucose, triglyceride cholesterol and insulin resistance, and the knowledge, beliefs and~     experiences on the use of technology to decrease sedentary behaviour and improve glycaemic~     control are not investigated in type-2 diabetic patients. Therefore, it would be relevant to~     investigate this to prove the therapeutic role of frequent short activity break in sedentary~     time in the management of type-2 diabetes.~      Primary Research Objective:~        1. To investigate the dose-response effect of frequency/number of light intensity walking~          breaks of sitting on postprandial glucose, insulin, C-peptide and triglyceride~          cholesterol level.~        2. To investigate the potential longer-term effect of light intensity walking breaks of~          sitting on glucose control using 24-h glucose data.~      Secondary Research Objectives: The secondary objectives are~        1. To obtain data to inform the development of a future feasibility trial investigating the~          feasibility, compliance, adherence and longer-term effect of different frequencies of~          light intensity walking breaks in sitting time on glycaemic excursions in free-living.~        2. To explore the knowledge, beliefs and experiences of those with Type 2 diabetes on the~          use of technology to decrease sedentary behaviour and improve glycaemic control, that~          could be used in the feasibility trial~   "
63252|NCT02738983|"~     Concurrent chemoradiotheray is the standard care for patients with locally advanced non-small~     cell lung cancer (NSCLC), but often accompanying with high toxicity and poor tolerability.~     Radiosensitization of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors~     (TKI) has been proved in preclinical studies, and the safety of TKI combined with thoracic~     radiotherapy has also been evaluated in several phase II trials. The aim of study is to~     investigate the efficacy and safety of thoracic radiotherapy combined with TKI in wild-type~     EGFR patients who refused or unsuitable for concurrent chemoradiotherapy.~   "
63253|NCT02738970|"~     This study involves a two-part design. Part 1 is designed to determine the optimal dose of~     subcutaneous (SC) Perjeta, injected alone or mixed with Herceptin, that results in comparable~     exposure to intravenous (IV) Perjeta. Exposure between SC Perjeta and IV Perjeta will be~     compared using a compilation of pharmacokinetic (PK) parameters such as area under the~     concentration-time curve (AUC), maximum serum concentration (Cmax), time of maximum~     concentration (Tmax), and serum trough concentration (Ctrough). Part 2 is designed to confirm~     the dosing regimen in women with EBC on the basis of safety, tolerability, and PK~     assessments.~   "
63254|NCT02738957|"~     Few studies have investigated breastfeeding in twins, and none have addressed the effect of~     antenatal counseling on breastfeeding twins.The purpose of this study is to investigate the~     effect of antenatal breastfeeding counseling on the breastfeeding rates in twin pregnancies.~   "
63268|NCT02738775|"~     This study evaluates the use of single agent ublituximab, a novel monoclonal antibody, in~     patients with relapsing forms of multiple sclerosis~   "
63255|NCT02738944|"~     Background: Community Health Centers care for over 20 million rural, low income and minority~     Americans every year. Patients often have complex mental health problems such as~     Posttraumatic Stress Disorder (PTSD) and Bipolar Disorder. However, Community Health Centers~     located in rural areas face substantial challenges to managing these patients due to lack of~     onsite mental health specialists, stigma and poor geographic access to specialty mental~     health services in the community. As a consequence, many rural primary care providers feel~     obligated, yet unprepared, to manage these disorders, and many patients receive inadequate~     treatment and continue to struggle with their symptoms. While integrated care models and~     telepsychiatry referral models are both promising approaches to managing patients with~     complex mental health problems in rural primary care settings, there have been no studies~     comparing which approach is more effective for which types of patients. Objectives: The~     central question examined by this study is whether it is better for offsite mental health~     specialists to support primary care providers' treatment of patients with PTSD and Bipolar~     Disorder through an integrated care model or to use telemedicine technology to facilitate~     referrals to offsite mental health specialists. We hypothesize that patients randomized to~     integrated care will have better outcomes than patients randomized to referral care. Methods:~     1,000 primary care patients screening positive for PTSD or Bipolar Disorder will be recruited~     from Community Health Centers in three states (Arkansas, Michigan and Washington) and~     randomized to the integrated care model or the referral model. Patient Outcomes: Telephone~     surveys will be administered to patients at enrollment and at 6 and 12 month follow-ups.~     Telephone surveys will measure access to care, therapeutic alliance with providers,~     patient-centeredness, patient activation, satisfaction with care, appointment attendance,~     medication adherence, self-reported clinical symptoms, medication side-effects, health~     related quality of life, and progress towards life goals. A sub-sample of patients will be~     invited to participate in qualitative interviews to describe their treatment experience using~     their own words. Likewise, primary care providers will be invited to participate in~     qualitative interviews to voice their perspective.~   "
63256|NCT02738931|"~     Dolutegravir (DTG) and lamivudine (3TC) are indicated in combination with other~     antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1)~     infection. Fixed dose combination (FDC) tablets of existing approved drugs are preferred by~     many patients and offer the potential for increased patient adherence and consequently a~     reduced likelihood of virological failure and viral resistance.~      The purpose of the present study is to evaluate the relative bioavailability of two~     experimental FDC tablets of DTG and 3TC relative to co-administration of the single entity~     products in healthy adult subjects.~      This study will be conducted as a randomized, open label three-way, crossover design with 6~     treatment sequences in approximately 30 subjects. Each subject will have a screening visit~     within 30 days prior to the first dose of study drug, three treatment periods each with a~     single dose of study drug and a follow-up visit within 7-14 days after the last dose of study~     drug. There will be at least 7 days washout between dosing periods. The total duration of~     participation of a subject in this study will be approximately 9 weeks.~   "
63257|NCT02738918|"~     BACKGROUND: Antibody-mediated humoral rejection is currently a critical question in renal~     transplant recipient with immunological risk factors such as pre transplant donor-specific~     anti HLA antibodies (DSA). The immunosuppressive management of the patients is still not well~     defined and improving both short and long-term graft outcome remains a challenging question.~     Recent experimental data suggest that Belatacept could induce B cell anergy , induce~     regulatory B cell and decrease Ig production. These findings are strengthened by the results~     of both phase II and III clinical studies, showing a significant lower incidence of DSA in~     patients treated with Belatacept compared to recipients receiving a conventional~     immunosuppressive regimen with calcineurin inhibitors (CNI).~      Primary objective will be the incidence of clinical and subclinical humoral rejection~     (According to BANFF 2011 Criteria). Secondary objectives will include one-year graft and~     patient survival, renal function at M12 (MDRD), incidence of cellular rejection (M 12), level~     of proteinuria (M3 and M12) and DSA outcome (outcome of DSA MFI at JO, M3 and M12). Inclusion~     period will be of two years. DSA identification and quantitative analysis before and after~     transplantation will be centralized in only one HLA laboratory Unit (Hospital Saint Louis)~     for providing results homogeneity.~      According to previous clinical studies, the incidence of Acute Antibody Mediated Humoral~     Rejection is close to 20% in patients with mild immunological risk defined by the presence of~     DSA at the time of transplant with mean fluorescence intensity (MFI) between 1000 and 3000~     (Luminex). In order to demonstrate a significant reduction (40%) of AAMR and sAAMR incidence,~     91 patients will be included in this study. Results will be compared to a cohort matched for~     age, sex, immunological risk factor (DSA), time of transplant, transplant center and grafted~     with a similar immunosuppressive regimen including CNI instead of Belatacept~   "
63258|NCT02738905|"~     The purpose of this study is to determine if rifaximin reduces serum trimethylamine-N-oxide~     (TMAO) levels in patients with end-stage renal disease.~   "
63259|NCT02738892|"~     This prospective non-intervention cohort study will enroll women in the first or early second~     trimester of pregnancy and follow them through delivery and 42 days postpartum.~      Infants will also be followed until 42 days after delivery. Detailed medical and obstetrical~     information will be collected, as well as biological samples, in order to better elucidate~     the biological mechanisms leading to preterm delivery among Zambian women, in an effort to~     identify new strategies for prevention.~   "
63260|NCT02738879|"~     This is a trial of continuing sitagliptin versus withdrawing sitagliptin in participants with~     Type 2 diabetes mellitus (T2DM) and inadequate glycemic control who initiate and titrate~     insulin glargine (LANTUS®) based on a treat-to-target algorithm to achieve fasting glucose~     levels of 72-100 mg/dL (4-5.6 mmol/L). A primary hypothesis of this trial is that after 30~     weeks, continuing sitagliptin results in a greater reduction of hemoglobin A1C (A1C) relative~     to withdrawing sitagliptin.~   "
63261|NCT02738866|"~     This study is being done to look at the role of continuing palbociclib treatment in~     combination with another type of hormonal therapy (fulvestrant) after disease progression of~     palbociclib in combination with an aromatase inhibitor.~   "
63262|NCT02738853|"~     The study objective is to evaluate safety and efficacy of the Medtronic TAVR (Transcatheter~     Aortic Valve Replacement) 2.0 system in patients with severe symptomatic aortic stenosis who~     are considered at high through extreme risk for surgical aortic valve replacement~   "
63263|NCT02738840|"~     A post market study evaluating the St Jude medical MR conditional neurostimulation systems.~   "
63264|NCT02738827|"~     Laser treatment of pTa low grade bladder tumours in the outpatient department~      Number of Subjects/Centres Planned: 20 patients will be included in this study. The study~     will be performed at Department of Urology, Bispebjerg-Frederiksberg Hospital, Copenhagen,~     Denmark.~      Primary Objective: To show that small pTa bladder tumours safely can be removed with diode~     laser in an outpatient department Secondary Objective: To evaluate the patients experience~     with the laser treatment using QOL questionaires (symptom evaluation) and Visual Analog Scale~     Score (pain evaluation).~   "
63265|NCT02738814|"~     This study aimed to verify the effects of propofol for treatment on emergence agitation (EA)~     after sevoflurane anesthesia in pediatric strabismus surgery.~   "
63279|NCT02738632|"~     Randomized, Double-Blind, Multi-Center, Phase 3 Trial to Evaluate the Efficacy and Safety of~     Telmisartan/Amlodipine/Hydrochlorothiazide Combination in Comparison with~     Telmisartan/Amlodipine Combination for Essential Hypertension Patients not Controlled by~     Telmisartan/Amlodipine Combination~   "
65910|NCT02704299|"~     Evaluate the feasibility ,safety and efficacy of Surgery，Chemotherapy in Combination with~     Autologous T cells-Based Immunotherapy for Advanced Gastric Cancer.~   "
63269|NCT02738762|"~     Earlier studies showed a benefit in survival when glutamine was given intravenously and these~     studies lead to recommendations that glutamine should be given to critically ill patients.~     The ESPEN guidelines recommend 0,2-0,4 g/kg/d intravenous glutamine added to standard~     parenteral nutrition .~      Until recently it was not possible to obtain a plasma glutamine level fast enough to consider~     the result for clinical decision making. With the availability of a Point of Care (POCT)~     measurement of plasma glutamine level a measurement can be performed short after the~     collection of blood. This offers the possibility to identify a patient with a low plasma~     glutamine level shortly after admission and use repeated measurements for evaluation of the~     response to supplementation of glutamine.~   "
63270|NCT02738749|"~     Congestive heart failure (CHF) represents a major health care concern in the United States.~     Currently, risk stratification of sudden cardiac death and the need for implantable~     cardioverter-defibrillator (ICD) placement are essentially dependent upon assessment of left~     ventricular ejection fraction (LVEF). Nevertheless, the predictive value of LVEF is~     suboptimal, alternative testing for risk assessment for the development of sudden cardiac~     death in the heart failure population is desirable.~      At the genome level, the investigator has focused on the role of SCN5A gene mutations in~     arrhythmogenesis. Lymphocyte SCN5A mRNA processing may serve as a surrogate marker to assess~     SCN5A function at the cardiac level and may correlated with arrhythmic risk in high risk~     populations. This study will determine if SCN5A variant levels are predictive of appropriate~     ICD therapies in patients with a newly implanted ICD.~   "
63271|NCT02738736|"~     Hypertension is a leading risk factor for cardiovascular disease (CVD) globally, accounting~     for 25-35% of the population-attributable fraction. Sodium (salt) intake is a key determinant~     of blood pressure, and reducing sodium intake has emerged as an important target for~     population-based interventions to prevent CVD. However, there is considerable uncertainty~     about the optimal level of sodium intake that is associated with lowest CV risk, and whether~     optimal levels differ for different populations and individuals. International and national~     guidelines recommend low sodium intake (<2.3g/day, or lower) in all persons, and advocate a~     population-wide approach to reducing sodium. Most of the world's population (~95%) consume~     between 3 and 6g/day of sodium (mean intake 4.0g/day), which means that most people will~     require a major change to their diet, to achieve the guideline target (<2g/day). While there~     is convincing evidence that high sodium intake (>5g/day) is associated with an increased risk~     of CVD, compared to low or moderate intake, the evidence that low sodium intake (<2.0g/day)~     is associated with a lower risk of CVD than moderate intake (2.0-5g/day) is inconsistent and~     inconclusive. The investigators plan to conduct a Phase IIb clinical trial to evaluate the~     role of low sodium intake (versus moderate) on cardiovascular biomarkers.~   "
63272|NCT02738723|"~     As stereotactic radiotherapy (SBRT) has been widely used in clinical practice at present, the~     aim of this study is to evaluate the efficacy and safety of stereotactic body radiation~     therapy compared with intensity modulated radiation therapy (IMRT) concurrently with EP~     regimen(cisplatin plus etoposide) in treating patients with limited-stage small cell lung~     cancer~   "
63273|NCT02738710|"~     This study compare outcomes (i.e. pain, wound infection, and patient satisfaction) between~     infra-umbilical vs. trans-umbilical incision after Laparoscopic cholecystectomy~   "
63274|NCT02738697|"~     Hepatocellular carcinoma (HCC) is the sixth most common malignancies worldwide and the second~     leading cause of cancer-related death. Surgical resection is still the main radical approach~     for HCC, but the recurrence rate after hepatectomy is very high, which hampers the further~     improvement of prognosis of HCC patients. The conventional risk factors of recurrence~     including: huge tumor, multiple lesions, vessels invasion and tumor rupture. Recently, the~     microvessels invasion (MVI) has been recognized a novel risk factor of recurrence after~     hepatectomy. The investigators' previous study showed that the recurrence rate is more than~     50% for the patients with >5cm solitary tumor and MVI. The MVI was confirmed as the only~     independent risk factor for the overall and disease-free survival of HCC patients in multiple~     variables analysis. It is important to reduce the recurrence and prolong the survival of~     patients after hepatectomy with effective adjuvant therapy. Reported at 2014 American Society~     of Clinical Oncology (ASCO) annual meeting, A phase III randomized, double-blind,~     placebo-controlled trial of adjuvant sorafenib after resection or ablation to prevent~     recurrence of hepatocellular carcinoma (STORM trial) failed to meet the primary~     endpoint-recurrence free survival (RFS). Given the inspiring result of a recent trial, which~     compared with single agent of doxorubicin, the oxaliplatin-containing regimens (FOLFOX)~     showed significant improvement in OS, objective response rate (ORR) and disease control rate~     (DCR) in Asian (especially China) HCC patients. Based on these rationales, the investigators~     design the current prospective randomized clinical trial to evaluate the effect of adjuvant~     chemotherapy with FOLFOX to prolong the overall survival and reduce the recurrence in HCC~     patients at high risk (>5cm solitary tumor and MVI) after resection, compared to vigilant~     follow-up.~   "
63275|NCT02738684|"~     This project aims to do a small sample exploratory study, to predict EGFR-TKI targeted~     therapy gefitinib' s efficacy in late stage lung adenocarcinoma patients (phase IIIB or IV),~     who have negative tissue EGFR gene mutation, positive plasma free nucleic acid EGFR gene.~   "
63276|NCT02738671|"~     The purpose of this study is to explore the relationship between diabetes and cognitive~     impairment by olfactory function assessment and functional MRI.~   "
63277|NCT02738658|"~     Background: A total of 25-50% of patients with stable coronary atherosclerosis treated with~     metallic stent implantation remain with effort angina despite optimal medical treatment and~     absence of stent restenosis at 1 year. The most plausible cause of persistent effort angina~     after stent implantation is microcirculatory dysfunction. Coronary circulation matches the~     myocardial blood supply and oxygen consumption. Metallic stent implantation has been related~     with endothelial dysfunction and impaired coronary blood flow reserve (relation between~     coronary blood flow at rest and maximal hyperemia) of the treated vessel at 1 year.~      Bioresorbable Vascular Scaffold (BVS) has been shown to improve the endothelial function and~     to improve the angina symptoms at 1 year. However, the coronary blood flow of BVS has never~     been tested.~      Main objective: To determine differences in the blood average peak velocity at maximal~     hyperemia with adenosine infusion between patients treated with bioresorbable and metallic~     coronary stents at 1 year after stent implantation.~      Methodology: A total of 70 patients are 1:1 randomized to everolimus-eluting metallic stent~     (EES) versus everolimus-eluting BVS implantation in patients with stable coronary disease. At~     1 year, patients undergo to invasive coronary angiography prior cessation of vasomotor drugs.~     A pressure/Doppler wire is advanced distally to the treated segment and the endothelial~     (acetylcholine) and non-endothelial (adenosine and nitroglycerine) vasomotor function is~     assessed with quantitative coronary angiography and pressure and Doppler measurements. Angina~     test questionnaires are obtained at different time-points of the study.~      Expected results: A difference between patients treated with BVS and EES of 12.0 cm/sc in the~     maximal average peak velocity (APV) under maximal hyperemia (with adenosine administration)~     is expected, as assessed by Doppler measurements, at 1 year after stent implantation. The~     study is powered to assess superiority in terms of maximal APV favoring patients treated with~     BVS.~   "
63288|NCT02738515|"~     The purpose of this double-masked, randomized, controlled clinical trial was to evaluate the~     effects of subgingival delivery of boric acid gel as an adjunct to scaling and root planing~     (SRP) on clinical and radiographic parameters and compare this method with SRP plus placebo~     gel alone in patients with chronic periodontitis (CP).~   "
65922|NCT02704143|"~     The safety and efficacy of combination of SBRT with Cyberknife with S-1 in treating~     pancreatic cancer will be evaluated.~   "
63280|NCT02738619|"~     Vitamin D as adjuvant to subcutaneous specific immunotherapy in patients with allergic~     rhinitis Specific allergen immunotherapy is the treatment of choice for patients with~     persistent allergic rhinitis. Some strategies to accelerate immunological and clinical~     changes to ensure an early response and improve adherence are needed. The administration of~     vitamin D along with conventional treatments in allergic patients with asthma or atopic~     dermatitis, pathophysiological entities like allergic rhinitis, reduces the severity of~     symptoms in less time.~      Primary endpoint. To evaluate the efficacy of vitamin D in terms of reducing the time of~     therapeutic response to subcutaneous specific allergen immunotherapy.~      Compare the time of clinical improvement and adherence to treatment among the group receiving~     vitamin D against the group receiving placebo Analyze the relationship between vitamin D~     values, total serum IgE, serum eosinophil and nasal cytology in both groups before and after~     treatment Assess the safety of vitamin D by serum calcium. TH17 and Treg quantify cells~     before and after treatment. MATERIAL AND METHODS This is a interventional, prospective~     clinical trial randomized placebo-controlled, double-blind study including paediatric~     patients (children 3-12 yr old) with allergic rhinitis, with parallel group: Immunotherapy +~     Placebo and Immunotherapy + Vitamin D. Patients prior informed consent include more patients~     being female and male of 3 to 12 years old. They will be randomized and in the same~     proportion. The sample was calculated using the G Power program to achieve an effect size of~     0.65, with alpha = 0.05, statistical power = 80% and 20% losses to mean difference of 2~     independent groups, the result was 80 patients, 40 per group. Monitoring will be conducted at~     0, 3 and 6 months, assessing clinical and laboratory parameters with the questionnaire RQLQ,~     TNSS, CARACT KIDS, ARIA, GINA.~      ANALYSIS It will be analyzed in SPSS. The results are expressed by descriptive statistics.~     For comparison of means will be used t student. It will be analyzed with ANOVA, variance for~     repeated measures in time, general linear model, structural equations, multivariate analysis,~     analysis of the main components. P values <0.05 were considered statistically significant.~   "
63281|NCT02738606|"~     The goal of this clinical research study is to compare the effect of having liver resection~     with standard of care chemotherapy to having standard of care chemotherapy alone in patients~     whose colorectal cancer has spread to their liver and lungs.~   "
63282|NCT02738593|"~     third generation of EGFR-TKIs is the newest target therapy for NSCLC. However, we did not~     known the specific mechanisms for those non-responders and patients grow resistance.Next~     generation sequencing is current the most sensitive and specific method to exam gene~     mutation, diversion etc.~      By consistently detect the cf-DNA, we could possibly find out the mechanisms of response and~     resistance.~   "
63283|NCT02738580|"~     Serum concentrations of the different hormones involved in follicular steroid genesis during~     a cycle of controlled ovarian stimulation with recombinant FSH or HMG will be compared in~     this study. Serum Progesterone (P) levels at the end of Controlled Ovarian Stimulation (i.e.~     the day of triggering) have been related to cycle outcome, in terms of ongoing pregnancy and~     live birth rates. Large cohort studies show that P levels above a certain threshold are~     associated with poorer cycle outcome. The mechanisms behind P elevation are not well~     understood yet. It has been shown that P levels are positively related to ovarian response~     and to the dose of FSH given during COS. Furthermore, it has been well documented that P~     levels at the end of stimulation are significantly higher when recombinant (r) FSH is used~     for COS when compared to HMG, either in a GnRH agonist long protocol or in a GnRH antagonist~     protocol. Some authors suggest that this finding is explained by the fact that COS with rFSH~     provides a higher oocyte yield than when hMG is given, so the higher P levels observed would~     be explained by the larger number of follicles developed when rFSH is used. On the other~     hand, other authors explain this event by a different follicular esteroidogenesis when HMG is~     used for COS compared to rFSH The hypotheisis behind this assumption is that rFSH enhances P~     synthesis from its precursor pregnenolone in the granulosa cells. This P is unable to be~     further metabolized into androgens because of the lack of 17-20 lyase in the human granulosa~     cells, and therefore is delivered into circulation. On the other hand, when HMG is given for~     COS, the ∆4 pathway is promoted, and pregnenolone will be catabolized in to~     Dehidroepiandrostenodione (DHEA), in the theca cells, and this one to Androstenodione, which~     will be finally aromatized in to estrogens. This mechanism will explain the lower P and~     higher E2 levels observed in HMG cycles in comparison to rFSH cycles.~   "
63284|NCT02738567|"~     The use of vasopressor supplement materials to local anesthetics is commonly used in~     procedures in various fields of dentistry, ENT (ear, nose, and throat), Plastic Surgery, Hand~     surgery and gastroenterology. Epinephrine is used to constrict small blood vessels, thus~     reducing bleeding during a medical procedure, reducing the toxicity by reducing systemic~     absorption of local anesthetic, and prolonging the duration and intensity of neural blockage~     created by the local anesthetic.~      There are descriptions in the literature of cases in which the use of lidocain and adrenaline~     caused adverse cardiac events such as arrhythmias, edema and increase in blood pressure~     during ENT and dentistry procedures. As far as we know there has never been a systematic~     examination of the incidence and severity of arrhythmias during procedures with local~     anesthesia.~      The purpose of the study:~        1. To examine the prevalence and types of arrhythmias in patients undergoing a medical~          procedure performed under local anesthesia~        2. Examine whether adding adrenaline to the local anesthetics affects the incidence of~          arrhythmia Determining the prevalence and types of arrhythmia will help determine the~          need for monitoring and type of monitoring required during procedures under local~          anesthesia.~      The patients:~      500 patients undergoing surgery or a medical procedure in which a local anesthetic is used at~     Meir Hospital. Patients with a medical history of known cardiac arrhythmia will not be~     included.~      Methods:~      Patients will undergo the medical procedure prescribed for them, using local anesthesia with~     or without adrenaline, at the discretion of the surgeon, in accordance with the usual routine~     being applied nowadays. The amount and type of anesthesia used will be registered. In~     addition to the routine monitoring that is currently performed (blood pressure cuff and~     non-invasive blood oxygen saturation) a continuous ECG monitoring device will be connected~     prior to the beginning of the surgical procedure, until the patient is discharged from the~     recovery room. The ECG monitoring results will be analyzed to detect arrhythmia. Side effects~     being reported by patients (palpitations, dizziness, fainting, CPR {cardiopulmonary~     resuscitation} ) will be recorded. In cases that an arrhythmia is detected, the type of~     arrhythmia and the presence of clinical symptoms will be investigated.~   "
63285|NCT02738554|"~     Treatment cessation in chronic hepatitis B is associated with high rates of disease relapse.~     However patients who achieve the seroclearance of hepatitis B surface antigen (HBsAg) (<0.05~     IU/mL) show good off-treatment durability after treatment cessation. Through the~     quantification of HBsAg, the study aims to investigate how low should quantitative HBsAg be~     before once can achieve successful disease control after treatment cessation.~   "
63286|NCT02738541|"~     The purpose of this study was to determine the anti-calculus effect of dentrifice containing~     5% sodium pyrophosphate and potassium pyrophosphate in a triple-mask placebo controlled~     randomized clinical trial.~   "
63287|NCT02738528|"~     Parkinson's disease (PD) is characterized by dopaminergic neurons degeneration of the~     substantia nigra, in the midbrain, resulting in the presence of motor disorders, such as~     tremor, rigidity, bradykinesia, and postural instability. Researches have shown that mental~     rehearsal in learning motor skills through mental practice (MP), which associates the~     physical practice to somatosensory imagination to action, causes positive effects in several~     motor tasks, such as the speed of motion, muscle strength performance and accuracy. Thus,~     this study aims to report the effects of MP as a tooth brushing training strategy in people~     with Parkinson's disease. This project was approved by the Ethics Committee in Research with~     Human beings of UFPE and attempt to compare the presence of bacterial biofilm before and~     after 8 weeks of brushing through the mental practice training, based on O'Leary's index. The~     sample consisted of 35 people, divided into two groups: Intervention Group consists of 17~     people with Parkinson's, in stages I to III of the disease, who underwent brushing~     orientation associated with PM, and the control group people without the disease, who~     received only orientation brushing. Then, the data were evaluated by factorial ANOVA 2x2 and~     post hoc Tukey test considering p <0.05. It was observed that after the intervention was a~     significant improvement of the control dental biofilm.~   "
72944|NCT02612181|"~     The investigators preliminary study showed that dexmedetomidine might improve~     microcirculation in septic shock patients. To test this effect, the investigators will~     conduct double-blinded study.~   "
63289|NCT02738502|"~     The overall goal is to study the feasibility of darunavir/ritonavir (DRV/r) monotherapy as~     treatment simplification (switch) in pretreated pregnant women, associated with neonatal~     prophylaxis with nevirapine, constituting a PMTCT strategy without any Nucleoside Reverse~     Transcriptase Inhibitor (NRTIs) .~   "
63290|NCT02738489|"~     This is an open-label, single center, non-randomized, dose escalation phase I trial to~     evaluate safety and tolerability of SHR-1210 in patients with advanced Melanoma. The primary~     objective is to assess safety and tolerability of SHR-1210 and identify recommended phase II~     doses of SHR-1210 in patients with advanced Melanoma.~   "
63291|NCT02738476|"~     The primary purpose of this investigation is to report the short-term clinical outcomes (2-3~     years) of patellofemoral arthroplasty implanted using the MAKOplasty knee resurfacing system.~   "
63292|NCT02738463|"~     Intrauterine growth restriction ( IUGR )is defined as fetal growth slower than the normal~     growth potential of a specific fetus because of genetic or environmental factors. Recently~     several studies have highlighted the role of many biomolecules as markers for IUGR.~     Measurement of maternal serum ferritin has also been used as a predictive marker for~     increased risk of IUGR. Iron deficiency has its known deleterious effect in pregnancy but~     iron loading may be associated with oxidative damage to cells and tissues. It has been shown~     in various studies that lower level of transferritin receptor expression in placenta is~     associated with preeclampsia and IUGR. This can lead to decrease extraction of iron by~     placenta from maternal serum leading to increase maternal serum ferritin. This fetal iron~     deficiency leads to increase in fetal corticotropins and fetal cortisol, causing inhibition~     of fetal growth~   "
63293|NCT02738450|"~     The purpose of this study is to test in adults with Down Syndrome the safety, tolerability~     and immunogenicity of a vaccine, ACI-24.~   "
63294|NCT02738437|"~     The aim of this study was to investigate the beneficial effect of bone cement in combination~     with wire cerclage on the stability of the sternum following median sternotomy.~      One half of the patients received only wire cerclage the other both bone cement and wire~     cerclage.~   "
63295|NCT02738424|"~     Lumbar spine bone marrow is well explored in Magnetic Resonance Imaging (MRI) but some bone~     marrow diseases are hard to analyze with this method. Furthermore, there is heterogeneity in~     normal bone marrow, called apparent diffusion coefficient (ADC). Histological and technical~     factors appear to be the cause, but the possible influence of the employed post-processing~     software has never yet been evaluated. The purpose of this study is to determine if there is~     variability in lumbar bone ADC related to the post-processing software.~   "
63296|NCT02738411|"~     The main objective of this research is to study the links between changes in the intestinal~     microbiota (in terms of diversity) during the first 6 weeks of life for preterm infants and~     the presence / absence of a TH1 immune status at 36 months of age.~   "
63297|NCT02738398|"~     Prospective study of the effects of image acquisition and reconstruction parameters on~     accuracy of FDG PET/CT mediastinal nodal staging in NSCLC~   "
63298|NCT02738385|"~     Several studies have shown relationship between exercise intensity and improvement~     cardiometabolic health. It has been suggested that high intensity interval training and also~     moderate training generate positive effects on metabolic risk factors. For these reasons, it~     is necessary to clarify which type of training, is more effective to improve cardiometabolic~     health in latinamerican population.~   "
63299|NCT02738372|"~     Background: Shoulder pain is the third most common musculoskeletal condition presenting to~     physicians or physiotherapists ) in primary healthcare after low back and neck pain being a~     significant cause of morbidity and functional disability in both working and general~     population. Despite the large group of individuals seeking for primary care services, about~     50% of patients with shoulder pain still report persistent pain after 12-18 months. As a~     result, socio-economic burdens are considerable due to extensive use of heath care services,~     sickness absence, disability pension, and loss of productivity as well as, patient´s~     suffering.~      Aims: the primary aim of this study was to evaluate what biopsychosocial factors predict a~     better and/or poor outcome in patients with Chronic shoulder pain. The secondary aim was to~     analyze the role of central sensitization in predicting a better and/or poor outcome in~     patients with Chronic shoulder pain.~      Hypothesis:~        1. A high level of physical inactivity, kinesiophobia, fear avoidance and pain~          catastrophizing and low level of self-efficacy will ease the perpetuation of Chronic~          shoulder pain.~        2. The presence of central sensitization will predict a poor outcome in patients with~          chronic shoulder pain.~   "
63300|NCT02738359|"~     Efficacy of colonoscopy, colon capsule and fecal immunological test for colorectal cancer~     screening, in first degree relatives of patients with colorectal neoplasia: a prospective~     randomized study.~   "
63301|NCT02738346|"~     The purpose of this study was to determine prospectively in all patients with SCLC in second~     line therapy that progression-free survival with the expected reintroduction of platinum /~     etoposide is greater progression-free survival in the standard arm (topotecan ) in patients~     who have relapsed at least three months after initial chemotherapy with platinum-etoposide~   "
63302|NCT02738333|"~     The primary objectives of this study are to evaluate the antiviral efficacy of therapy with~     ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) and to evaluate the safety and~     tolerability of LDV/SOF FDC and sofosbuvir (SOF) + ribavirin (RBV) in participants with~     chronic genotype 2 hepatitis C virus (HCV) infection.~   "
63303|NCT02738320|"~     The purpose of this study is to develop a consumer friendly web-based interface between~     Nursing Home Compare (NHC) and an e-coaching/decision-aid tool (NHCPlus) and determine if use~     of NHCPlus facilitates and enhances access to and use of NHC.~   "
63304|NCT02738307|"~     Prospective interventional trial in lowlanders evaluating the effect of acute exposure,~     acclimatization and re-exposure to high altitude on global cognitive function.~   "
63305|NCT02738294|"~     The aim of the present study was to assess whether it was necessary to conduct magnifying~     endoscopy with narrow band imaging (ME-NBI) targeted biopsy compared with endoscopic forceps~     biopsy (EFB) from white light endoscopy in diagnosing early gastric cancer (EGC). Meanwhile,~     the investigators proposed the most cost-effective way to diagnose EGC.~   "
66476|NCT02696850|"~     The goal of this research project is to explore the impact of the addition of budesonide to~     high-volume, low-pressure nasal sinus saline irrigation (aka Neti-Pot-type systems) for~     patients with chronic rhinosinusitis with or without nasal polyps.~   "
63306|NCT02738281|"~     The purpose of this study is to advance understanding of the natural history of Rett syndrome~     (RTT), MECP2-duplication disorder (MECP2 Dup), RTT-related disorders including CDKL5, FOXG1,~     and individuals with MECP2 mutations who do not have RTT including the range of clinical~     involvement and to correlate genotype-phenotype over a broad spectrum of phenotypes. While~     much has been learned about RTT, improvements are required in understanding the role of~     factors such as X chromosome inactivation, genetic background, and others including the~     environment, on the great variability observed even between individuals with the same MECP2~     mutation. These data will be essential to the development and conduct of clinical trials that~     are anticipated from ongoing studies in animal models for RTT. This study will not include~     clinical trials, but should set the stage for such trials and other translational research~     projects (e.g., development of biomarkers).~   "
63307|NCT02738268|"~     Up to 90% of the radiotherapy patients will develop a certain degree of skin reaction at the~     treated area, also known as radiodermatitis (RD).~      Currently, there is a wide variety of strategies to manage RD, including creams, gels,~     ointments, wound dressings. However, up to now, there is still no comprehensive,~     evidence-based consensus for the treatment of RD. Low-level laser therapy (LLLT) is a~     promising, non-invasive technique for treating RD. In a recent study conducted in our~     research group, LLLT prevented the aggravation of RD and provided symptomatic relief in~     patients undergoing radiotherapy for breast cancer after breast-sparing surgery. This was the~     first prospective study investigating the potential of LLLT for RD. In the current study, we~     want to investigate the efficacy of LLLT as a tool for the prevention of radiodermatitis in~     head and neck cancer patients.~   "
63308|NCT02738255|"~     Test the effect of added a single-use Varnum mouthpiece on pharyngeal collapsibility and~     obstructive sleep apnea (OSA) severity in patients who identify themselves as mouth~     breathers. Research indicates that nasal breathing not only may improve sleep apnea but it~     also increases circulation, blood oxygen, and carbon dioxide levels, slows the breathing~     rate, and improves overall lung volumes. Thus, the investigators will test whether a~     single-use Varnum mouthpiece can improve pharyngeal collapsibility and OSA severity in mouth~     breathers.~   "
63309|NCT02738242|"~     The Novus system intended to provide ankle dorsiflexion and knee flexion or extension in~     individuals with foot drop and thigh muscle weakness, following an upper motor neuron injury~     or disease. The primary objective of the study is to evaluate the usability of the Novus~     system among these patients and to gain subjects' feedback regarding the device when used on~     a daily basis.The secondary objective is to obtain information about the performance of the~     system as a gait assistive device and to evaluate the subject's Quality of Life while using~     the system.~   "
63310|NCT02738229|"~     Primary herpetic gingivostomatitis is a frequent problem in pediatrics. Complications of this~     are dehydration, pain and hospitalisation. The objective of this randomized controlled trial~     is to assess the clinical efficacy of oral Valacyclovir to decrease the duration of symptoms~     associated with acute herpes gingivostomatitis in children. This study will involve 80~     children aged 1 to 8 years old to receive weight adjusted doses of valacyclovir for 7 days.~     The primary outcome measure will be the duration (in days) of feeding and/or drinking~     difficulties.~   "
63311|NCT02738216|"~     This NICHD-funded RCT will enroll up to 178 depressed pregnant women, randomly assigning them~     to one of 2 intervention conditions: (1) a gentle prenatal yoga program (PYP), or (2) a~     series of educational workshops focused on perinatal health, the Mom and Baby Wellness~     Workshop (MBWW), each condition lasting 9 weeks. The investigators will clinically monitor~     all participants in the study for safety and clinical deterioration, and measure a variety of~     symptom outcomes over the course of the intervention period during pregnancy, as well as at a~     postpartum follow-up.~   "
63312|NCT02738203|"~     For intrauterine device (IUD) insertion, currently there are no standardized clinical~     guidelines for pain management. The investigators aim to explore whether adequate pain relief~     is possible through self-administered, non-invasive means alone. Reducing pain associated~     with IUD insertion may benefit patients and providers. When patients are comfortable during~     their procedure, it is likely the provider can more quickly and with fewer complications~     perform the insertion. The investigators propose to explore the effect of a locally applied~     vaginal lidocaine gel in place of the standard of care pain management, no intervention,~     prior to IUD insertions. This is a superiority, blinded, randomized controlled trial.~   "
63313|NCT02738190|"~     This is a randomized controlled trial that compares two different priming composition~     (albumin vs. fresh frozen plasma) for extracorporeal circulation of pediatric patients under~     10 kg of weight. The two approaches are both employed at the moment but there is actually no~     evidence on the superiority of one over the other. This study is aimed to test the hypothesis~     that Albumin is superior to fresh frozen plasma in terms of minor bleeding and transfusional~     requirements.~   "
63314|NCT02738177|"~     Ninety healthy pregnant women candidate for surgical evacuation after confirming 1st~     trimester pregnancy loss were enrolled in the study. They were randomized in three groups;~     misoprostol group in which 30 candidates were receive 2 tablets of misoprostol (i.e. 400 ug)~     4 hrs prior to surgical evacuation, Effox group in which 30 candidates were received 2~     tablets of Effox (i.e 40 mg) 4 hrs prior to surgical evacuation & combination therapy group~     in which 30 candidates were received 1 tablets of misoprostol 200ug & 1 tablets of Effox 20~     mg 4 hrs prior to surgical evacuation. For all participants, the route of administration was~     the intravaginal route 1ry outcomes included cervical consistency & dilatation immediately~     before the procedure. 2ry outcomes included total duration of the operation and the~     occurrence of drug-related side effects~   "
63315|NCT02738164|"~     Investigators aim to evaluate the SEPSIS 3 criterion for sepsis and septic shock in a~     prospective manner.~      Investigators will evaluate qSOFA performances and other SEPSIS 3 criterion in a population~     of emergency patients with infection~   "
63337|NCT02737878|"~     Dementia is one of the most pressing health care issues of the 21st century. Evidence~     suggests that exercise enhances cognitive function in healthy older adults. Most research has~     focused on aerobic training (AT). Therefore, investigators aim to assess the individual~     effects of AT and resistance training (RT), as well as the interaction effect of combining~     the two types of exercise training, on cognitive function in older adults with mild cognitive~     impairment.~   "
63316|NCT02738151|"~     Primary Objective:~      To demonstrate the noninferiority in the efficacy of Toujeo® to Tresiba® in glycated~     hemoglobin (HbA1c) change.~      Secondary Objectives:~        -  To assess the effects of the insulin Toujeo® in comparison with insulin Tresiba® on:~        -  Change in Fasting plasma glucose (FPG);~        -  Change in Fasting self-monitored plasma glucose (SMPG) and 4-point SMPG and 8-point SMPG~          profile;~        -  Percentage of patients reaching HbA1c targets <7% or ≤6.5%;~        -  Percentage of patients reaching HbA1c targets <7% or ≤6.5% without severe and/or~          confirmed hypoglycemia~        -  Percentage of patients requiring rescue therapy.~        -  To assess the frequency of occurrence and diurnal distribution of hypoglycemia by~          American Diabetes Association (ADA) category of hypoglycemia.~        -  To assess the safety in each treatment group.~        -  To assess the treatment effects in each treatment group on Patient Reported Outcomes~          (PRO).~   "
63317|NCT02738138|"~     The purpose of this study is to assess the efficacy and safety of ABT-493/ABT-530 in adults~     with chronic hepatitis C virus genotype 1-6 infection and human immunodeficiency virus-1~     co-infection.~   "
63318|NCT02738125|"~     This study assesses the long‐term effectiveness of adalimumab in subjects starting a~     treatment for ulcerative colitis in real life conditions, namely to describe the time to loss~     of clinical benefit in a time to event approach.~   "
63319|NCT02738112|"~     Hyo-mandibular suspension has been previously studied as a treatment for obstructive sleep~     apnea (OSA) and has shown to be highly effective.~      This is a prospective, multi-center, registry during which 30 subjects with OSA will be~     considered for hyo-mandubular suspension treatment. After obtaining informed consent and~     meeting all inclusions and exclusion criteria, subjects will be treated using the Encore~     System. Subject follow-up with the physician or nurse will occur at one (1) week, one (1)~     month, three (3) months, and twelve (12) months.~      This study will assess the effectiveness of hyoid suspension in reducing the apnea-hypopnea~     index (AHI), and improving the Epworth Sleepiness Scale (ESS), snoring (VAS) and functional~     outcome (FOSQ) for the treatment of obstructive sleep apnea (OSA). In addition, the study~     will evaluate the effect that the change in hyoid position has on the airway anatomy.~   "
63320|NCT02738099|"~     Method: Single center, prospective, non-randomized, unblinded case series of all patients~     presenting with a cardiac arrest. The proposed study will collect data on all comatose~     patients presenting with cardiac arrest. The primary end point is death from any cause at 30~     days from admission.~      Significance: Develop criteria to guide an invasive strategy for comatose patients presenting~     with cardiac arrest, and so avoid ineffective or even futile therapy which carry its own~     significant risks for patients in the future. The criteria, in turn, can serve as the basis~     for a prospective, randomized trial in the future.~   "
63321|NCT02738086|"~     This pilot study will use mobile-health technology to deliver an intervention designed for~     lasting physical activity behavior change. The study will assess the feasibility of using the~     Physical Activity Behavior Change(PABC) intervention for Veterans with lower limb amputation.~     This intervention will be delivered using wrist-worn wearable activity sensors and a~     home-based tablet computer to allow real-time physical activity feedback and video interface~     between the participants and the therapist.~   "
63322|NCT02738073|"~     Tranexamic acid (TA) inhibits fibrinolysis by binding to lysine binding-sites of plasminogen~     to fibrin. Fibrinolysis is stimulated by surgical trauma, and the administration of TA has~     been shown effective in decreasing blood loss both intra-operatively and in the immediate~     post-operative period in elective hip and knee arthroplasty patients. Both the timing and~     dosing of TA has been investigated in these patients. Subsequent blood transfusion rate has~     also been shown to decrease as result of TA administration. Despite the support for TA~     utilization that exists in the arthroplasty literature, the data is scarce regarding its~     administration during surgical treatment of hip fractures. This is patient population who is~     at high risk for transfusion due to symptomatic post-operative anemia. This study aims to~     investigate whether TA's advantageous effects in the arthroplasty patient population can be~     extrapolated to the more unstable, heterogeneous hip fracture patient population. If the~     study is able to show a difference in blood loss and transfusion requirement, the long term~     implications of this with regards to cost and mortality can be significant.~   "
63323|NCT02738060|"~     To investigate the effect of baked milk in immunotherapy of cow's milk allergy.~   "
63324|NCT02738047|"~     Pharmocogenomic test assessment in the medication regimen and disease management for patients~     under drugs known with genetic variation.~   "
63325|NCT02738034|"~     Systemic arterial hypertension is a disease with high prevalence in several countries,~     including Brazil. Many studies have correlated hypertension with accelerated loss of~     cognitive function, especially executive functions. There is some evidence that working~     memory (WM) is compromised in these populations. However, some computerized training has been~     developed to rehabilitate the WM, and among them the investigators highlight the Cogmed.~     Thus, the aim of this study is to evaluate the effects of Cogmed training in the performance~     of WM and attention of hypertensive patients, as well as the impact of training in the~     structure and brain function.~   "
63338|NCT02737865|"~     Focal nodular hyperplasia (FNH) in liver is the second common benign hepatic tumor. It~     usually shows hypervascular mass on imaging studies and it is not easy to differentiate with~     other hypervascular malignant tumor. For diagnosis of FNH, contrast-enhanced ultrasonography~     (US) has been used to detect 'spoke-wheel sign', which can be typically seen in FNH. However,~     temporal window of vascular phase using contrast-enhanced US (CEUS) is very short (about 10~     sec) and coordination of patient`s respiration during US exam is absolutely needed. Thus, the~     investigators will use Superb-Microvascular imaging (SMI, Toshiba, Japan) for detection of~     'spoke-wheel sign' in patients with proven FNH, which enable to detect slow micro vascular~     flow without using CEUS.~      First, to compare the detection rate of 'spoke-wheel sign' between CEUS using sonazoid~     (Perfluorobutane, GE healthcare) and SMI.~      Second, to compare the accuracy of size measurement between gray-scale US and SMI (reference~     standard: CEUS using sonazoid.)~   "
63339|NCT02737852|"~     To evaluate the safety of a new personal lubricant when used at least four times weekly for~     two weeks (including at least twice weekly during sexual intercourse for subjects with~     monogamous male partners), in a population consisting of healthy females.~   "
63326|NCT02738021|"~     A Stepped Care pathway for managing postpartum depression (PPD) in pediatric primary care~     settings will be used to (1) understand context for implementation feasibility (2) evaluate~     benefits for mother and child.~      The proposed pilot project will be conducted as part of a quality improvement effort in the~     Department of Pediatrics at Gouverneur Health Services to improve management of postpartum~     depression during pediatric primary care visits. This project will test the feasibility of a~     stepped care approach to identifying and managing depression among mothers of infants (0-6~     months). This study will provide preliminary data on the feasibility of the care management~     protocol, implementation and fidelity measures, and training/consultation methods within a~     real world pediatric care practice. These data will inform and support the preparation of a~     large-scale NIH grant.~      Specific research questions include:~        1. To pilot the feasibility of using a Stepped Care Approach to identify and mange maternal~          depression within primary care pediatric care visits, with a focus on mothers of infants~          0-6 months.~             1. Train non specialty MH providers to systematically identify maternal depression.~             2. Assess how effective integration of maternal depression intervention is as part of~               well baby visits.~        2. To o examine the impact of STRONG, a brief 3-session IPT-based preventive intervention,~          on maternal and child health outcomes (e.g., maternal depression symptoms, child receipt~          of acute care services). Secondary outcomes include maternal social support and~          parenting practices.~   "
63327|NCT02738008|"~     Chronic HBV patients will receive 9 doses of open-label ARC-520 once every 4 weeks and be~     evaluated for safety and efficacy.~   "
63328|NCT02737995|"~     Iron deficiency may contribute to exercise intolerance by altering mitochondrial oxidative~     capacity in skeletal muscle. Functional iron deficiency is common in heart failure patients,~     but the relationship to exercise intolerance and mitochondrial oxidative capacity is unknown.~     This is a pilot study to determine the feasibility of the use of specialized 31P-MRS and MRI~     techniques for measurement of skeletal muscle bioenergetics in patients with heart failure~     with and without functional iron deficiency.~   "
63329|NCT02737982|"~     The application of sex-gender medicine is strongly recommended by World Health Organization~     and other international organization. In fact, it is emerging that, although men and women~     are affected to the same cardiovascular diseases (CVD), however they have different risk~     factors, disease progression and response to pharmacological and not-pharmacological~     treatments. Consequentially, the identification of biomarkers and therapeutic approaches~     taking into account sex gender differences (SGD) is relevant to develop a really~     evidence-based medicine.~      With the aim of translate in clinical setting the more recently available basic research~     evidences on estrogens and androgens balance involvement in modulation of~     ischemia-reperfusion myocardial damage, the investigators planned to conduct a research study~     on patients, affected by suspected or known ischemic heart disease (IHD) undergoing~     angiography and/or percutaneous coronary interventions (PCI), aged more than 18 years of both~     sex in ratio 1:1. Thus, in this setting, the goals of this proposal are:~        1. To assess the sex-gender difference in entity of microvascular reperfusion damage in~          patients with IHD undergoing urgent or elective PCI;~        2. To evaluate estrogen/androgen-dependent and -independent effects in gender-related~          differences on myocardial ischemia reperfusion damage occurring during PCI;~        3. To investigate the differences in terms of platelet biology between men and women~          affected by IHD undergoing urgent or elective PCI, matched for age and clinical~          cardiovascular and metabolic characteristics;~        4. To verify sex-driven interplay between response to PCI procedure, platelet function, sex~          hormones and entity of reperfusion and myocardial damage, as well as, the impact on~          clinical outcomes during a 1-year follow up.~      This research study wants to explore and consequently elucidate biological mechanisms~     responsible for sex-based differences in vivo human models of ischemia reperfusion myocardial~     damage. Moreover, the investigators expected to clarify the impact of biological variables~     evaluated on clinical outcomes after reperfusion therapeutic intervention.~   "
63330|NCT02737969|"~     This is a pilot study of patients undergoing structural heart disease procedures that utilize~     TEE and fluoroscopic guidance at the New York University (NYU) Langone Medical Center.~     Patients in this study will undergo their procedure utilizing the TEE/Angio fusion software~     prototype. This protocol is primarily intended to ascertain the potential utility of the~     software prototype in the study population and to provide data and feedback to improve the~     workflow and algorithms of the prototype. As such, a primary outcome variable and statistical~     analysis plan have not been identified. However, procedural time, measures of radiation~     exposure (dose area product, total radiation dose, fluoroscopy time), degree of residual~     valvular regurgitation or paravalvular regurgitation as applicable, and complications will be~     recorded.~   "
63331|NCT02737956|"~     This study is to build a Xinjiang people registry and surveillance system for acute~     myocardial infarction(AMI) in2012-2015years to obtain real-world information about patient's~     basic information, patient characteristics, diagnostic test mode, the program of treatment~     and hospitalization outcomes including mortality, treatment complications, the cost of~     hospitalization and follow-up terminal events (death, major adverse cardiac events, minor~     adverse cardiovascular events)of xinjiang AMI patients; And to propose scientific precaution~     strategies aimed to prevent effectively from the incidence of AMI; And to optimize the~     management and outcomes of AMI patients through implementation of guideline recommendations~     in clinical practice, and analysis and development of effective treatment strategies; And to~     create cost-effective assessment system.~   "
63332|NCT02737943|"~     40 Egyptian Cases with split-thickness skin graft receiving treatment at Zagazig University~     Hospitals. Study Duration:6 Months .Description of Agent or Moist Exposed Burn Ointment~     (MEBO).~      Intervention:~      Objectives: Primary: to determine the efficacy of MEBO versus standard care in improving the~     healing speed and re-epithelization process of skin graft donor and recipient sites.~     Secondary to determine the efficacy of MEBO in decreasing recovery time, rate of infections,~     rate of complications, total treatment costs and its effect on improving pain alleviation.~      Description of Study Design: Arm 1 20 MEBO at sites of donor graft and recipient at time of~     operation and in dressing Arm 2 20 Standard cream Zagazig University Hospital (Antibiotics &~     analgesics) Estimated Time to Complete 5 months~   "
63333|NCT02737930|"~     The purpose of this study is to determine whether fluoxetine, a selective serotonin reuptake~     inhibitor commonly used for depression, enhances visual recovery after an acute ischemic~     stroke.~   "
63334|NCT02737917|"~     To determine the impact, if any the application of oxygen during the apnea period of rapid~     sequence intubation has on patients being intubated in the emergency department.~   "
63335|NCT02737904|"~     This randomised controlled trial aims to explore the effectiveness of a four week programme~     of exercise using lower limb Active Passive trainer (APT) (MOTOmed trainer) in terms of~     spasticity in people with moderate to severe Multiple Sclerosis.~   "
63336|NCT02737891|"~     Safety and Efficacy Study of Tesofensine/Metoprolol Treatment in Subjects With Type 2~     Diabetes Mellitus~   "
63340|NCT02737839|"~     Chronic disease self-management is the ability of the individual, in conjunction with family,~     community and healthcare professionals to manage symptoms, treatments, lifestyle changes and~     psychosocial, cultural and spiritual consequences associated with a chronic condition.~     Self-management strategies have been successfully used in supportive care and survivorship in~     oncology. Stepping On, a multi-component program using a small-group learning environment,~     reduces falls by 31%. It empowers participants with knowledge about fall-risk, exercise,~     medications and environmental hazards to self-manage their risk of falls over 7 weeks of~     educational sessions, followed by a home visit. The research in this proposal will yield the~     adaptation of the effective group-education-based fall-prevention intervention Stepping On,~     tailored to cancer patients, feasible for testing in a multi-institutional trial, and~     ultimately scalable in the oncology setting.~   "
63341|NCT02737826|"~     Chronic opioid therapy for pain can be associated with significant risks, and a significant~     number of patients maintained on chronic opioids have continued pain and/or poor functioning.~     When patients need to or want to come off their opioid pain medications, there is little to~     guide physicians as to how to best help them do so, and it is not known how patients do after~     coming off opioid medications. The goals of this study are (1) to evaluate two medications in~     assisting patients in coming off their opioid pain medications and (2) determining outcomes~     after discontinuing opioids.~   "
63342|NCT02737813|"~     Spinal block leads to the reduction of systemic vascular resistance (SVR) which may effect~     the cardiac output. Ngan Kee et al. has showed that spina block with 0.5% hyperbaric~     bupivacaine for Cesarean section combined with intravenous infusion norepinephrine had higher~     cardiac output than those who received phenylephrine~   "
63343|NCT02737800|"~     Investigators compare ICSI results for endometrioma patients with or without cyst aspiration~     if more than 5cm &with or without GnRh agonists for all endometrioma patients~   "
63344|NCT02737787|"~     The purpose of this study is to test the safety of a combination of an investigational WT1~     vaccine and another drug called nivolumab. This is the first time that the WT1 vaccine and~     nivolumab are being used in combination.~   "
63345|NCT02737774|"~     This is a prospective, open, single-center, phase Ⅱ study to assess the efficacy and safety~     of alternating Icotinib and chemotherapy for advanced non-small cell lung cancer with EGFR~     mutation.~   "
63346|NCT02737761|"~     The purpose of the study is to understand how positive emotions (e.g., optimism, happiness)~     are associated with health behavior adherence in patients with heart failure (HF), as well as~     whether performing exercises to improve positive emotions may help to improve health behavior~     adherence as well.~   "
63347|NCT02737748|"~     Primary objective:~        1. To evaluate the safety of TWB-103 in split-thickness skin graft donor site wounds (DSW)~          for Phase I in terms of Incidence of treatment-related AEs and SAEs (including~          infections and bleeding)~        2. To evaluate the efficacy for Phase I+II of TWB-103 in split-thickness skin graft donor~          site wounds (DSW) in terms of The healing time from DSW creation to 100%~          re-epithelialization~      Secondary objective:~        1. To evaluate the efficacy of TWB-103 in split-thickness skin graft donor site wounds~          (DSW) in secondary efficacy endpoints~        2. To evaluate the safety of TWB-103 in split-thickness skin graft donor site wounds (DSW)~          in secondary safety endpoints~   "
63348|NCT02737735|"~     To study the effect on decreasing chemotherapeutic toxicity and increasing anti-tumor~     treatment of Chinese Herbs based on syndrome differentiation~   "
63349|NCT02737722|"~     Phase I/IIa, five cohort ascending dose with two dosing arms per cohort, study in Type I or~     II diabetes mellitus subjects with a chronic infected diabetic ulcer defined as having a DUSS~     score of 0 to 3 and DFI wound score of 1 to 3.~   "
63350|NCT02737709|"~     By detecting the blood concentration of paclitaxel (PTX), Investigator assume this research~     can identify the individual differences of PTX pharmacokinetics (PK) parameters (TC>0.05~     refers to the duration of paclitaxel plasma concentration above 0.05 µmol/L) in Chinese~     non-small cell lung cancer (NSCLC) patients, and find the correlation between PK results and~     PTX toxicities and Effectiveness, acquire the optimization method of PTX, and finally try to~     explore the individualized PTX pharmacokinetically-guided dosing strategy. Orally administer~     rosiglitazone, which is a substrate of CYP2C8 the same as paclitaxel, before chemotherapy~     injection. Detect the blood concentration of rosiglitazone, analyze the correlation of~     rosiglitazone pharmacokinetic parameter and paclitaxel exposure, and explore the effect of~     rosiglitazone as an in vivo probe of paclitaxel exposure.~        1. The variability of paclitaxel concentrations in the patient population dosed by body~          surface area (BSA), and the limitation of BSA-based dosing of paclitaxel.~        2. Verify that paclitaxel TC>0.05 is the most relevant predictor of haematological toxicity~          and clinical outcomes.~        3. Define a dosing algorithm based on paclitaxel TC>0.05 of paclitaxel and quantify its~          effect on both reducing toxicity and improving Effectiveness.~        4. The effect of using dose modification and administration of G-CSF based on toxicity~          determined by paclitaxel TC>0.05 measurement.~        5. Construct a trial outline with the aim of reducing grade 4 neutropenia toxicity and~          ensuring the clinical outcome by using individual dose adjustments based on the dosing~          algorithm.~        6. Detect the blood concentration of rosiglitazone after orally administration, explore the~          effect of rosiglitazone as an in vivo probe of paclitaxel exposure based on CYP2C8~          activity. Attempt to establish a model to predict the paclitaxel exposure of patients~          base on rosiglitazone blood concentration before chemotherapy.~   "
63351|NCT02737696|"~     The investigators are developing an interactive, web-based program for youth ages 12-17~     focused on the prevention of prescription opioid abuse because to the investigators~     knowledge, no science-based, interactive program focused on the prevention of prescription~     opioid abuse among youth exists. This program is grounded in a scientific understanding of~     risk factors for prescription opioid abuse among youth, employs informational technologies~     which are effective in promoting relevant knowledge and skills, and presents program content~     using strategies shown to be highly appealing to adolescents. In the completed Phase 1 of~     this project, the investigators developed and demonstrated the scientific, technical and~     commercial merit and feasibility of a prototype of a web-based, prescription opioid abuse~     prevention program for youth. In Phase 2, the investigators will complete the development of~     all components of the multimedia, prescription opioid abuse prevention program and conduct a~     randomized, controlled trial with youth to evaluate the effectiveness of the web-based~     prevention intervention in increasing knowledge about key issues relevant to prescription~     opioid abuse among youth, skills acquisition relevant to preventing their misuse, negative~     attitudes about prescription opioid misuse, and perceived risk associated with their misuse.~     The investigators will also assess the program's effectiveness in reducing intentions to~     misuse prescription opioids as well as actual rates of such use. If this tool is shown to be~     effective, the investigators plan to embed it in a suite of science-based,~     technology-delivered tools focused on the prevention and treatment of substance use disorders~     that have been developed and deployed in a wide array of settings by the investigative team.~   "
63352|NCT02737683|"~     Patients with indigestion were often found in gastroenterology clinic, those who about 20 %~     was caused by organic, while the rest of patients are showed abnormal inspection, and these~     are so called functional dyspepsia. Functional dyspepsia is a chronic and repeated occurrence~     of digestive disorders, patients often visit hospitals frequently and unable to get fully~     cured. Current Symptom diagnoses are based on Rome III criteria as diagnostic criteria.~     Although functional dyspepsia condition should combine with physical and mental treatments,~     due to the reasons behind the complex, there is still no effective classification could be~     acted in health education and drug intervention.~   "
63353|NCT02737670|"~     The objective of this prospective randomized and double blind controlled study is to evaluate~     the efficacy and safety of Sulodexide (25 mg) in the treatment of chronic idiopathic~     subjective tinnitus.~   "
63354|NCT02737657|"~     The primary purpose of this study is to describe the tolerability of canagliflozin and any~     sulphonylurea (each administered with metformin with or without a DPP-4 inhibitor), in terms~     of the percentage of patients with at least one episode of hypoglycaemia, in patients with~     T2DM who fast during Ramadan.~   "
63355|NCT02737644|"~     The study is a nested case-control study and the purpose is to describe the status of key~     nutrients(eg.folic acid and vitamins) supplementation among pregnant women in Shanghai, to~     find out the association between the level of serum key nutrients during peri-conceptional~     period and the incidence of congenital heart defects (CHD) in newborn, and to provide better~     preconception care.~   "
63356|NCT02737631|"~     The purpose of this test is to evaluate the sensitizing potential of a personal lubricant, as~     a result of repeated occlusive patch. The intervention will be applied for a total of 9~     induction applications, followed by an approximately 2 week rest period, then followed by a~     24-72 hour Challenge applications.~   "
63357|NCT02737618|"~     to determine the ability of the test article to cause irritation to the skin of humans under~     controlled patch test conditions~   "
63358|NCT02737605|"~     The purpose of the study is to assess the effects of esketamine on QT/QTc intervals and~     electrocardiogram (ECG) morphology at therapeutic exposures of esketamine and noresketamine~     (intranasal administration) and supratherapeutic exposures of esketamine (intravenous~     administration) in healthy adults.~   "
63359|NCT02737592|"~     To evaluate the safety of a personal lubricant when used at least four times weekly for two~     weeks (including at least twice weekly during sexual intercourse for subjects with monogamous~     male partners), in a population consisting of healthy females.~   "
63360|NCT02737579|"~     This study will evaluate the use of x-ray fused with MR images as an imaging tool to help~     guide catheter tools during diagnostic and therapeutic cardiac catheterization procedures.~   "
63361|NCT02737566|"~     The primary objectives of this study are 1) to evaluate the longer-term impact of an~     adjunctive, low-cost financial incentives intervention (relative to standard care) on smoking~     abstinence rates among socioeconomically disadvantaged individuals participating in a~     clinic-based smoking cessation program and 2) to identify treatment mechanisms and contextual~     factors associated with cessation outcomes among intervention participants using both~     traditional and ecological momentary assessment approaches. Those randomized to the financial~     incentives intervention will have the opportunity to earn small gift cards for~     biochemically-verified abstinence through 12 weeks post-quit. We hypothesize that individuals~     who are randomly assigned to the adjunctive CM intervention will have significantly higher~     rates of biochemically-verified abstinence at the 26-week post-quit follow-up than those~     assigned to Usual Care. In addition, we hypothesize that several factors related to~     socioeconomic disadvantage will be directly associated with non-abstinence, especially~     greater stress/adversity, limited psychosocial resources, greater negative affect, greater~     nicotine dependence, and poorer treatment adherence. The primary study endpoints will include~     self-reported tobacco use/abstinence, expired carbon monoxide (CO) levels (i.e., the amount~     of carbon monoxide present in an individual's breath when they breathe out), and saliva~     cotinine levels at 26 weeks post-quit attempt, though smoking status will be assessed at all~     visits. Traditional questionnaire measurement and ecological momentary assessment (EMA) will~     be utilized to measure potential treatment mechanisms including motivation, self-efficacy,~     and treatment adherence. Other variables including stress/adversity, psychosocial resources,~     negative affect, nicotine dependence, and treatment adherence will also be assessed.~   "
63362|NCT02737553|"~     Laparoscopic tissue removal is one of the most challenging parts for the laparoscopic~     surgery. For this reason, electromechanical morcellation has long been used to facilitate the~     tissue removal in gynecology. However, electromechanical morcellation has long been performed~     inside the abdomen without any containment. Therefore, this practice has recently undergone~     increased scrutiny because of important concerns related to tissue dissemination during~     intracorporeal power morcellation. Thus, the US Food and Drug Administration released a~     safety communication discouraging power morcellation in laparoscopic hysterectomy and~     myomectomy procedures in April 2014.~      As a result of this serious concern, the enclosed laparoscopic power morcellation has been~     come into prominence in gynecological surgery. Besides the removal of the tissues through~     vagina with posterior colpotomy is considered an another solution for this critical problem.~      In the literature the comparison for the two techniques for tissue removal is considerably~     scarce. Therefore researchers are aiming to prepare a trial to compare the laparoscopic~     enclosed electromechanical morcellation and tissue removal thorough vagina with posterior~     colpotomy according to surgical time, postoperative pain and postoperative sexual function.~   "
63363|NCT02737540|"~     The main objective of this study is to confirm the existence of risky decision making in a~     non strategic situation (Iowa Gambling Task) and a deficit of decision making in social~     situations, linked to greater sensitivity to injustice (Ultimatum Game) and a lower level of~     trust (Trust Game) in elderly depressed patients with a history of suicide attempts in~     comparison with older depressed patients without a history of suicidal acts and healthy~     subjects.~   "
63364|NCT02737527|"~     This study compares the efficacy of the ultrasound with fluoroscope in guidance of lumbar~     sympathetic block (LSB). The goals of the study are; 1) To show that US-guided LSB results in~     shorter performance time compared to fluoroscope-guided LSB, 2) To evaluate the efficacy and~     safety of US-guided LSB, and 3) To verify that US-guided LSB has similar success rates to~     fluoroscope-guided LSB. 50 patients who are supposed to undergo LSB due to sympathetically~     maintained pain, satisfy criteria of inclusion and exclusion, and voluntarily sign the~     informed consent will be enrolled.~   "
63375|NCT02737384|"~     The purpose of this study is to evaluate selective depletion of naïve CD45RA+ T cells from~     allogenic peripheral blood stem cell graft in children transplanted for combined immune~     deficiency. The aims of this procedure are to prevent graft versus host disease (GVHD) while~     preserving anti-infectious response from donor memory T lymphocytes.~   "
72945|NCT02612168|"~     Prospective, single-arm, cross-sectional, study to establish the effectiveness of MIAA to~     detect melanoma in pigmented lesions, compared to gold standard histological determination.~   "
63365|NCT02737514|"~     Interval (missed) cancers and lower than expected mortality reduction of proximal colon~     cancers in the United States and elsewhere after screening colonoscopy drew attention to~     quality indicators. Missed adenomas which are more likely to be in the proximal colon may be~     contributing factors. An independent predictor of the risk of interval cancers is adenoma~     detection rate. In pilot observations, the investigators showed that water exchange enhanced~     adenoma detection in the right colon (cecum to hepatic flexure). This prospective, randomized~     controlled trial will compare water exchange with water immersion and traditional air~     insufflation in patients undergoing colonoscopy. The investigators test the hypothesis that~     compared with air insufflation and water immersion, water exchange produces a significantly~     higher adenoma detection rate in the right colon~   "
63366|NCT02737501|"~     A Phase 3 Multicenter Open-label Study of Brigatinib (AP26113) versus Crizotinib in~     ALK-positive Advanced Lung Cancer Patients~   "
63367|NCT02737488|"~     The purpose of this study is to evaluate if a trauma treatment called Trauma Systems Therapy~     (TST) decreases children's mental health symptoms (such as acting out, not controlling their~     emotions, etc.) as a result of a traumatic event (or events). A traumatic event or events can~     include experiencing or witnessing violence, excessive bullying, war, car accident, serious~     injury, getting mistreated or anything else that makes one feel scared or frightened.~     Children/teens who experience traumatic events have been shown to be at higher risk of poor~     mental and physical health. Trauma can impact family life, school life and interpersonal~     relationships well into adulthood. Unfortunately, most children who have experienced~     traumatic events do not undergo treatment. Although promising treatments do exist, most do~     not address the complexity of trauma, particularly related to ongoing stress and threats to~     safety in their environments. One hundred and twenty eligible youth will be randomized to~     receive either treatment with TST at NYU's Child Study Center or trauma treatment as usual~     (TAU) at a community mental health clinic.~      It is hypothesized that:~        -  Youth receiving TST will demonstrate a greater decrease in Post-Traumatic Stress~          Disorder (PTSD) symptoms at the 3, 6, and 9-month follow-up assessments compared to~          youth receiving treatment as usual (TAU) in the community.~        -  Youth receiving TST will demonstrate a greater decrease in symptoms of depression,~          anxiety and problem behaviors (aggression, violence, self-destructive behaviors, etc.)~          at the 3-, 6- and 9-month follow-up assessments compared to youth receiving TAU.~        -  Youth receiving TST will have fewer acute mental health service events, such as~          psychiatric hospitalizations and ED visits compared to youth receiving TAU.~        -  Greater fidelity to the TST model is associated with better treatment outcomes among~          youth receiving TST.~   "
63368|NCT02737475|"~     The purpose of the study is to determine the safety and tumor-shrinking ability of~     experimental medication BMS-986178, when given by itself or in combination with Nivolumab~     and/or Ipilimumab, in patients with solid cancers that are advanced or have spread.~   "
63369|NCT02737462|"~     <Part I - Phase I trial> The phase I clinical trial is to identify the MTD (Maximum Tolerated~     Dose) and DLT (Dose Limiting Toxicity) of CG200745 PPA. Initial dose of CG200745 PPA is 150~     mg/m^2, and it will be extended to 225 mg/m^2, 300 mg/m^2 or it will be reduced to 75 mg/m^2~     based on the results of the cohort of 3 subjects per dose level.~      Based on the 3+3 dose escalation study design, CG200745 PPA is to be administered as in four~     different cohorts according to the dose level. Each cohort consists of 3 or 6 subjects.~      <Part II - Phase II trial> In the phase II clinical trial, the subjects will be administered~     with the dose which is to be identified as a recommended dose based on the results of Phase I~     study. The whole one cycle is consisted of 28 days, same as the phase I. The entire treatment~     period is 6 cycles and tumor assessment is evaluated every 2 cycles.~   "
63370|NCT02737449|"~     The primary objective is to prospectively study the comparative effectiveness and comparative~     safety of approved therapies for RA in a Japanese cohort of patients treated by~     rheumatologists. Specifically the effectiveness and safety of newer classes and dosages of~     disease modifying anti-rheumatic drugs (DMARDs); e.g. higher dose methotrexate (MTX),~     non-tumor necrosis factor (TNF) biologics, and Janus Kinase (JAK) inhibitors) will be~     compared with anti-TNF biologics.~   "
63371|NCT02737436|"~     The investigators plan to conduct functional MRI scanning with a group of mothers who are~     blindly and randomly assigned either intranasal oxytocin or a placebo. The purpose of this~     investigation is to explore how oxytocin may modify early maternal brain and behavioral~     responses to infant cues. This study will examine, for the first time, a potential~     pharmacological intervention for maternal neglect which targets core neurobiological~     deficits. This may eventually be used to supplement and augment other psychosocial and~     behavioral interventions.~      In addition, the investigators will examine sex differences in parental brain and behavioral~     responses to oxytocin by also recruiting the male partner of enrolled mothers to participate~     in a similar protocol.~   "
63372|NCT02737423|"~     The main objective of the study is to assess the effect of vitamin D treatment on painful~     diabetic neuropathy in Pakistan.~      This is a prospective study of diabetic patients with a DN score ≥ 4, administered a single~     dose of 600,000 IU of Vitamin D.~      All diabetic patients (type 1 and type 2) at the screening visit were considered eligible to~     participate in the study. The change in painful diabetic neuropathy scores was assessed using~     DN4 Neuropathic Pain Diagnostic Questionnaire and SF - MPQ for all participants at each~     visit.~   "
63373|NCT02737410|"~     Background:~      Resilience refers to a class of variables highly relevant for wellbeing and coping with~     stress, trauma, and chronic adversity. Despite its significance for health, resilience is~     hardly examined empirically and suffers from poor conceptual integration. Irritable bowel~     syndrome (IBS) is a functional disorder with altered psychological stress reactivity and~     brain-gut-microbiota axis, which causes high chronic strain. Gut-focused hypnotherapy (GHT)~     is a standardized treatment for IBS targeting at resilience. An increase of resilience by GHT~     has been hypothesized but requires further investigation.~      Aims of the study were construct validation and development of an integrational measure of~     different resilience domains by dimensional reduction, and investigation of change in~     resilience in IBS patients by GHT.~      N=74 Gastroenterology outpatients with Irritable Bowel Syndrome (Rome III criteria) were~     examined in 7 resilience domains, quality of life, psychological distress and symptom~     severity. n=53 of these participate in 7 to 10 Gut-directed Hypnotherapy group sessions~     (Manchester protocol). Post-treatment examinations were performed 10 months after last GHT~     session.~   "
63374|NCT02737397|"~     The purpose of this study is to determine the safety and efficacy of a combination product~     for the prevention of veisalgia. Common symptoms of veisalgia following the moderate~     consumption of alcohol includes headache, fatigue, and thirst. It is the investigators~     hypothesis that a combination of two drugs can alleviate or significantly reduce these~     symptoms when taken before the start of moderate alcohol consumption.~   "
66717|NCT02693678|"~     Delayed onset muscle soreness (DOMS) can have an impact on the proprioception of knee joint .~     The study aim is to assess the effect of manual massage, diathermy and sham diathermy the~     proprioception of the knee joint in patients affected by DOMS.~   "
63376|NCT02737371|"~     Double blind, placebo controlled, ascending multiple (10) oral dose, sequential group study.~     Twenty-four subjects will complete the study in 3 cohorts (Groups A to C), each group~     consisting of 8 subjects. Each cohort will consist of 4 male and 4 female subjects. Each~     subject will be dosed for 10 days and will be on study for approximately 7 weeks. Each~     subject will participate in one treatment cohort only, residing at the Clinical Research Unit~     (CRU) from Day -1 (the day before dosing) to Day 15 (120 hours post the last dose). The dose~     will range between 2 and 10 mg/kg daily, given as either a single daily dose or as two doses~     divided over the 24-hour dosing period.~      All subjects will return for a post-study visit 8 to 10 days after the last dose of study~     medication.~      Cohorts will be dosed at least at 3 weekly intervals. There will be a review of the safety~     and pharmacokinetic data of each cohort prior to each dose escalation.~   "
63377|NCT02737358|"~     The purpose of this study is to assess the effects of administering N-Acetylcysteine (NAC) to~     assist in initial cessation and/or relapse prevention in adult cigarette smokers.~   "
63378|NCT02737345|"~     1. Further characterize the incidence of hyperfibrinolysis in cirrhotics~        2. Correlate hyperfibrinolysis with~             1. hepatitis C~             2. alcoholic liver disease~             3. the subset of a&b with renal failure with and without dialysis~        3. Better describe the hyperfibrinolytic ROTEM profile in cirrhotics~   "
63379|NCT02737332|"~     The purpose of this study is to evaluate the serum testosterone levels in patients with~     Metastatic Castration-Resistant Prostate Cancer on SoluMatrix™ Abiraterone Acetate as~     Compared to Abiraterone Acetate~   "
63380|NCT02737319|"~     The investigators analyzed the HMG-CoA reductase inhibitor, rosuvastatin, for the prevention~     of contrast-medium-induced nephropathy in patients undergoing primary angioplasty.~   "
63381|NCT02737306|"~     This is a Phase II, randomized, double-blind, placebo-controlled, multi-center study to~     evaluate the feasibility of the use of PRO 140 as an add-on therapy to standard GVHD~     prophylaxis treatment for prevention of acute GVHD in adult patients with AML or MDS~     undergoing allogeneic stem-cell transplantation.~   "
63382|NCT02737293|"~     This project will evaluate the daily intake of whole eggs in the Mediterranean Diet (Med~     Diet). Cholesterol levels are normally related to cardiovascular disease (CVD) risk. Dietary~     fat and the total diet makeup are well known modifiers of CVD risk. The Med Diet has been~     shown to decrease blood lipids (fats) and reduce inflammation. Cholesterol intake from eggs~     may not be as bad as once thought and, in fact, may help to improve the blood lipid (fat)~     levels. This study is being done to test how the addition of eggs to a Med Diet affects blood~     lipids and other risk markers for CVD.~   "
63383|NCT02737280|"~     Infants with viral bronchiolitis are currently treated with oxygen therapy if oxygen~     saturation is low. In earlier observational clinical studies, the use of high flow nasal~     cannulae therapy in infants with bronchiolitis has been associated with a decreased rate of~     intubation and intensive care. This study is a randomized controlled trial in two pediatric~     university hospitals in Finland comparing high flow nasal cannulae therapy to usual oxygen~     therapy in infants with bronchiolitis.~   "
63384|NCT02737267|"~     This study evaluates the relationship between several genetic variants and the response to a~     hypocaloric diet, in order to design a genetic test which permits prescribe the more~     personalized diet for each individual according to her genotype. Half of the participants~     will assigned to a moderate high protein diet, while the other half will assigned to a high~     carbohydrate diet.~   "
63385|NCT02737254|"~     The purpose of this study is to investigate the effects of oxytocin and a cognitive bias~     modification (CBM) procedure on children's trust in their mother.~   "
63386|NCT02737241|"~     HoLEP (Holmium laser enucleation of the prostate) entails dissection of the whole median and~     lateral prostatic lobes off the surgical capsule via a retrograde approach starting at the~     apex. The enucleated lobes were pushed to the bladder followed by hemostasis of the prostate~     bed then intravesical morcellation of the enucleated adenoma.~      The investigators are going to compare safety and efficacy of low power; LP-HoLEP vs. high~     power; HP-HoLEP in treatment of infra-vesical obstruction secondary to BPH (Benign prostate~     Hyperplasia).~   "
63387|NCT02737228|"~     <Part I - Phase I trial>~      The phase I clinical trial is to identify the MTD (Maximum Tolerated Dose) and DLT (Dose~     Limiting Toxicity) of CG200745 PPA in combination use of Gemcitabine and Erlotinib. Initial~     dose of CG200745 PPA is 187.5 mg/m^2, and it will be extended to 250 mg/m^2, 312.5 mg/m^2 or~     it will be reduced to 125 mg/m^2 based on the results of the cohort of 3 subjects per dose~     level.~      Based on the 3+3 dose escalation study design, Gemcitabine and Erlotinib are administered as~     fixed doses, whereas CG200745 PPA is to be administered as in four different cohorts~     according to the dose level. Each cohort consists of 3 or 6 subjects.~      <Part II - Phase II trial>~      In the phase II clinical trial, the subjects will be administered with the dose which is to~     be identified as a recommended dose based on the results of Phase I study. The whole one~     cycle is consisted of 28 days, same as the phase I. The entire treatment period is 6 cycles~     and tumor assessment is evaluated every 2 cycles.~   "
63388|NCT02737215|"~     Background. Atrial fibrillation is one of the most common complications in the postoperative~     period of coronary artery bypass grafting (CABG) surgery and usually associated with~     increased length of hospital stay and higher hospital costs. Among the main mechanisms~     involved, excessive sympathetic activation, oxidative stress and inflammation are fundamental~     elements in the pathophysiology of obstructive sleep apnea. Objectives. To evaluate the~     effects of continuous positive airway pressure (CPAP) in reduction of atrial fibrillation~     after CABG in patients with obstructive sleep apnea. Methodological procedures: A multicenter~     randomized controlled study to compare the incidence of atrial fibrillation between the~     intervention group and the control group, both monitored seven days with Holter.~   "
63389|NCT02737202|"~     This study is being done to determine if there is a potential benefit of saracatinib in LAM~     subjects. Based on the information of this trial, additional clinical development trials will~     be needed. The study will also test the tolerability of 125 mg of saracatinib given once~     daily over a 9 month period.~   "
63437|NCT02736578|"~     This phase I/II trial studies the side effects and best dose of cetuximab-IRDye 800CW when~     used with intraoperative imaging and to see how well they work in finding pancreatic cancer~     in patients undergoing surgery. Cetuximab-IRDye 800CW may help doctors better identify cancer~     in the operating room by making the cancer visible when viewed through a special imaging~     device.~   "
63390|NCT02737189|"~     Endovascular treatment of acute ischemic stroke has shown strong benefit in several~     prospective randomized trials in the anterior circulation and endovascular therapy for~     basilar artery occlusion has shown promising results in several single-arm studies. This has~     led to a broad adoption of these techniques which are now considered standard of care in many~     institutions despite the lack of adequate evidence to prove their benefit. Indeed, the rates~     of symptomatic intracerebral hemorrhage in these studies have consistently been around 5%~     which raises the question as to whether patients could actually be harmed as opposed to~     helped by these procedures. This is a prospective, multi-center, randomized, controlled,~     open, blinded-endpoint trial, with the aim to evaluate the hypothesis that mechanical~     embolectomy with the Solitaire device is superior to medical management alone in achieving~     better outcomes in subjects presenting with an acute ischemic stroke caused by occlusion of~     the basilar artery within 6-24 hours from symptom onset.~   "
63391|NCT02737176|"~     This study is to verify the efficacy of tobacco cessation in patients with oral diseases;~     periodontitis, dental implant and oral mucosal diseases by a multicenter prospective trial.~     Tobacco cessation intervention is implemented for 12 weeks. During the tobacco cessation~     intervention for the subjects, attending doctors implement standard treatments for their oral~     diseases. Improvement of each disease is evaluated between smoking cessation intervention~     group and non-cessation intervention group.~   "
63392|NCT02737163|"~     The treatment of hydrocephalus is the most time consuming, and arguably the most important~     role of the pediatric neurosurgical service at most children's' hospitals. Despite many~     technological advances, cerebral spinal fluid (CSF) shunting procedures remain the mainstay~     of hydrocephalus treatment. While often lifesaving, CSF shunting procedures are associated~     with high complication rates and account for a disproportionate share of health care~     expenditures and morbidity.~      Programmable CSF shunt valves, through which CSF flow and pressure can be adjusted by quick~     and painless transcutaneous reprogramming, have been implanted for more than 15 years in the~     developed world. Reprogramming these valves relies on rotational magnetic forces, which are~     applied by neurosurgeons and neurosurgical advanced practice providers. Inadvertent~     reprogramming (IR) can occur when patients with these valves are exposed to magnetic fields~     in the environment, which may lead to serious symptoms that may require urgent reprogramming~     and/or surgery.~      The concurrent proliferation of magnetically sensitive programmable CSF shunt valves and~     household items that generate substantial magnetic fields has caused concern among patients,~     parents and providers about the potential consequences of inadvertent valve reprogramming.~     This growing concern led the FDA to issue a warning to individuals with programmable valves~     in 2014, which deemed the programmable valves safe for use but vulnerable to IR when~     household devices such as tablets or cell phones are placed within 2 inches of the valve. The~     FDA recommended further study, stating that no systematic evaluation had been performed~     regarding the prevalence of accidental valve adjustments.~      By evaluating each of the patients with magnetically susceptible CSF shunt valves, during~     each of the routine points of contact with the service, investigators aim to define the~     prevalence of inadvertent shunt reprogramming, to correlate with the presence and absence of~     symptoms and radiographic changes, and to evaluate the risk of inadvertent shunt~     reprogramming based on exposure to common environmental items.~   "
63393|NCT02737150|"~     Aim of the study is to demonstrate equivalence of second-generation self-expandable valves~     (CoreValve Evolut R) in comparison to second-generation balloon-expandable valves (Edwards~     Sapien 3) and of local anesthesia with conscious sedation in comparison to general anesthesia~     with respect to safety and efficacy in high-risk patients with severe aortic stenosis~     undergoing transcatheter aortic valve implantation.~   "
63394|NCT02737137|"~     In clinical practice, local anesthetic injection pressure monitoring is performed manually or~     by a pressure transducer according to the availability of the equipment or preferences of~     clinicians. To date, no comparative study has measured the advantages of this measure during~     PNB.~      The aim of this study is to evaluate injection pressure monitoring in order to reduce the~     risk of intraneural injection during peripheral nerve blocks~   "
63395|NCT02737124|"~     Patients that are to undergo isolated meniscectomy will be randomized to 2 cohorts: one will~     take the FDA recommended dose of acetominophen (1000mg) 24hrs before surgery, one will be~     given a similarly looking placebo pill. A multitude of post-op variables will be included,~     mainly pain scores and morphine equivalent doses at different time points.~   "
63396|NCT02737111|"~     This study aims to further understand the experiences of children, their parents and siblings~     around the time when the child and their family are informed of a diagnosis of an inherited~     cardiac condition (ICC). The researchers are interested to understand how families experience~     the process of receiving a diagnosis of an ICC, and explore experiences from multiple~     perspectives within the family (i.e. parents, children and siblings).~      The Primary Project Objective:~      How do children, their parents and siblings experience the communication of a diagnosis of an~     inherited cardiac condition (ICC)? What is found to be helpful and less helpful?~      The Secondary Project Objective:~      To explore qualitatively how families experience the communication of a positive diagnosis~     for an inherited cardiac condition for a child and will seek the perspectives of the child~     with the diagnosis, their siblings and parents.~   "
63397|NCT02737098|"~     The Veterans Health Administration (VHA) provides care to 3.3 million Veterans living in~     rural areas, comprising 36% of all VHA enrollees. In 1995, VHA began expanding its system of~     Community Based Outpatient Clinics (CBOCs) in order to improve access for the geographically~     dispersed Veteran population. There are now approximately 900 CBOCs delivering a range of~     services to approximately 64% of VHA enrollees. While these CBOCs have dramatically improved~     access to first class primary care services, it has been more challenging to deliver~     specialty mental health care to rural Veterans. Evidence based specialty mental care~     practices developed for large VA Medical Centers are often not feasible to deploy in small~     CBOCs and thus not accessible to rural Veterans. Rural Veterans with posttraumatic stress~     disorder (PTSD) treated at CBOCs experience little to no improvement in their symptoms over~     time. A major contributor of poor PTSD outcomes is that trauma-focused evidence-based~     psychotherapy is not being provided to Veterans in the CBOC setting. Moreover, travel~     barriers prevent most rural Veterans from receiving trauma-focused evidence-based~     psychotherapy at large VHA Medical Centers (VAMC). Telemedicine Outreach for PTSD (TOP) is a~     technology-facilitated virtual care clinical intervention that is designed to enhance access~     to evidence based psychotherapy and pharmacotherapy. The VHA Office of Rural Health and~     Office of Connected Health and Telehealth Services intend to deploy the TOP intervention~     nationally. This project will lay the ground work for this national implementation~     initiative.~      The goal of this implementation project is to support the national deployment of the TOP~     intervention and evaluate its clinical effectiveness in routine care. The specific aims are~     to compare the cost and effectiveness of alternative implementation strategies to promote~     uptake of TOP and assess impact on access and PTSD outcomes.~      The project will be conducted at 6 VAMCs and affiliated CBOCs without on-site psychologists~     trained in trauma-focused evidence-based psychotherapy. The total anticipated sample size~     will be 600.~      The TOP clinical intervention is delivered by a virtual care team comprising a CBOC provider,~     and a telephone care manager, telepsychologist and telepsychiatrist located at the VAMC. The~     telephone care managers will coordinates care. The telepsychologists will deliver of~     trauma-focused evidence-based therapy. The telepsychiatrists will provide psychiatric~     consultation. The standard VA implementation strategy will follow standard procedures for~     deploy clinical practices in the VA include disseminating support materials, providing~     technical assistance and transfer funds to hire clinical personnel. The enhanced~     implementation strategy will add external facilitation to the standard VA implementation~     strategies. External facilitation will begin with an assessment of the current workflow at~     the VHA Medical Center and the affiliated CBOCs. The external facilitation team will then~     generate a clinical workflow chart that describes the current process of care. With advice~     from the external facilitation team, local staff will then incorporate the clinical process~     of the TOP intervention into the current clinical workflow chart.~      The project will compare the standard VA implementation strategy to the enhanced~     implementation strategy. All VAMCs will receive the enhanced implementation strategy if they~     need it, but the time period during which they will receive the enhanced implementation~     strategy will be randomized. This will allow us to determine whether more patients are~     reached by the TOP intervention during standard implementation compared to enhanced~     implementation. This design will also allow us to document improvements in perceived access~     and PTSD outcomes for patients at sites that successfully implement the TOP intervention.~     Data will be collected from patient survey and chart review for all patients sampled for the~     evaluation. Participating patients will complete a baseline survey and 3 follow-up surveys.~     The reach implementation outcome measure will be specified as the proportion of sampled~     patients who received the TOP intervention. PTSD outcomes will be specified as a continuous~     change in patient self-reported symptom severity between baseline and follow-up. Perceived~     access will be measured using items specifically developed for the project. Provider adoption~     will be assessed with qualitative interviews of all CBOC clinicians treating a sampled~     patient as well as members of the TOP intervention team. Costs - The investigators will~     measure the cost of both implementation strategies both prospectively and retrospectively.~     The investigators will collect data on implementation activities during both the standard VA~     and enhanced implementation strategies.~   "
63398|NCT02737085|"~     The main purpose of this study is to explore the sequential therapeutic effect of~     CD19-targeted and CD20-targeted chimeric antigen receptor T(CAR-T) cells in the treatment of~     Diffuse Large B Cell Lymphoma(DLBCL)~   "
63399|NCT02737072|"~     The main purpose of this study is to evaluate the safety and tolerability of chemokine (C-X-C~     Motif) receptor 4 (CXCR4) peptide antagonist LY2510924 and durvalumab for phase 1a and 1b in~     participants with advanced refractory solid tumors.~   "
63400|NCT02737059|"~     This research study was being done to study the effect of codeine and Naloxegol for 3 days~     compared to placebo on the movement of food through the colon of healthy individuals. Codeine~     is a commonly used pain-relieving drug that often causes constipation as an unwanted side~     effect. Naloxegol is a medication recently approved by the FDA for treatment of constipation~     induced by Codeine.~      The hypothesis for this study was that Naloxegol reduces the retardation of small bowel and~     colonic transit induced by codeine in healthy participants.~   "
63401|NCT02737046|"~     The investigators propose to use Belinostat in combination with AZT as consolidation therapy~     for the treatment of ATLL.~   "
63402|NCT02737033|"~     This study evaluates the use of Rhodiola rosea in the attention of adults with Attention~     Deficit/Hyperactivity Disorder (ADHD). Half of participants will receive Rhodiola rosea~     800mg, while the other half will receive 800mg of placebo.~   "
63403|NCT02737020|"~     This study evaluates the use of Rhodiola rosea in the treatment of Attention~     Deficit/Hyperactivity Disorder (ADHD) in adults. Half of participants will receive Rhodiola~     rosea, while the other half will receive placebo.~   "
63452|NCT02736383|"~     To determine if TXA utilization is effective at reducing transfusion rates in elderly~     patients undergoing surgery for treatment of a hip fractures.~   "
63404|NCT02737007|"~     This is an open-label, single-centre, non-randomized study to investigate the~     pharmacokinetics of GSK3191607, administered as a single intravenous (IV) dose in healthy~     male subjects.~      Six subjects will be administered an IV microdose of radio-labeled [14C]-GSK3191607. The~     study will provide an early readout on human pharmacokinetic parameters. The results of this~     study will be used to estimate the potential duration of anti-parasite effect in humans,~     define predicted clinical oral doses, and hence inform about the compound's potential safety~     margin.~      Each subject will participate in the study for up to 8 weeks, and will have a screening~     visit, one treatment period, eight outpatient visits, and a follow-up visit.~   "
63405|NCT02736994|"~     The aim of this study is to evaluate the effect of PIP toothbrush cleaner® on the microbial~     composition and Candida albicans colonization of denture biofilm formation. Additionally, its~     effect will be compared to that of cleansing tablets.~   "
63406|NCT02736981|"~     This is a 3-arm randomized controlled trial to test the efficacy of three novel motivational~     approaches to weight loss with 18-25 year olds. Participants will be 18-25 year olds with a~     BMI of 25-45 kg/m2, randomized to: 1) Behavioral Weight Loss (BWL), 2) BWL + Autonomous~     Motivation (BWL+Aut) or 3) BWL + Extrinsic Motivation (BWL+Ext). All arms will receive a~     6-month behavioral weight loss intervention, followed by a 6-month no-treatment follow up~     period.~   "
63407|NCT02736968|"~     This is a phase IIa, randomized, placebo-controlled, single-blinded superiority treatment~     study to compare placebo to once daily doses of 6mg auranofin for adults with amebiasis or~     giardiasis. A sample size of 68 subjects enrolled with amebiasis (34 per arm) and 68 with~     giardiasis (34 per arm); Power based on 60 subjects with amebiasis and 60 with giardiasis~     completing the study. Primary objectives are 1) to compare the proportion of subjects with~     stools positive by rapid EIA and positive antigen detection EIA for E. histolytica at~     enrollment with resolution of diarrhea (less than 3 loose stools/24 hrs) by Day 7 for E.~     histolytica infections and 2) to compare the proportion of subjects with stools positive by~     rapid EIA and positive antigen detection EIA for Giardia at enrollment with resolution of~     diarrhea (less than 3 loose stools/24 hrs) by Day 5 for Giardia infections. The length of~     this study is set for 3.5 years; subject participation is 7 days treatment (amebiasis) and 5~     days (giardiasis) with follow-up until day 28~   "
63408|NCT02736955|"~     This Phase 3b, rollover study will provide subjects who completed a Phase 3 valbenazine~     (NBI-98854) study open-label access to valbenazine (fixed doses administered once daily) for~     the treatment of TD until valbenazine is anticipated to be available commercially or they~     complete 72 weeks of treatment. This study will allow enrollment of up to 75 medically stable~     male and female subjects with TD who previously participated in and completed the~     NBI-98854-1304 (Kinect 3) or NBI-98854-1402 (Kinect 4) Phase 3 study.~   "
63409|NCT02736942|"~     Background Surgery for mid and low rectal cancer is associated with relative high rates of~     incomplete mesorectal excisions and high rates of circumferential resection margin (CRM)~     involvement resulting in significant number of local recurrences. Moreover, patients with mid~     and low rectal cancer suffer from high rates of morbidity, permanent colostomies and~     impairment of quality of life. The transanal TME (TaTME) has been developed to improve the~     quality TME in mid and low rectal cancer.~      Study design The COLOR III trial is an international multicentre randomised study comparing~     short- and long-term outcomes of TaTME and laparoscopic TME for rectal cancer. The study will~     include a quality assessment phase before randomisation to ensure required competency level~     and uniformity of the new TaTME technique and the laparoscopic TME. During the trial clinical~     data will be reviewed centrally to ensure uniform quality.~      Endpoints Primary endpoint is involvement of CRM. Secondary endpoints include morbidity and~     mortality, residual mesorectum (postoperative MRI), local recurrence, disease-free and~     overall survival, percentage of sphincter saving procedures, functional outcome and quality~     of life.~      Statistics In laparoscopic TME the percentage of involved CRM is estimated 7%. To detect a~     reduction to 3% with a two-sided level of significance of 5% and a power of 80% a total of~     1098 patients is needed. Randomisation will be in a 2:1 ratio in favour of the TaTME~     procedure. It will be stratified for T-stage, preoperative radiotherapy, height of the~     tumour, gender and BMI. All analyses will be on intention-to-treat basis.~      Main selection criteria Patients with a histologically proved single mid or low rectum~     carcinoma (0-10cm from anal verge) on MRI, eligible for TME surgery with a curative intent,~     are included. Main exclusion criteria are T4 tumours, T3 tumours with a suspected involved~     mesorectal fascia (MRF) after neoadjuvant therapy, patients with concomitant metastases or~     other malignancies, with malignancies in their medical history or with signs of acute~     mechanical obstruction by the tumour.~      Hypothesis The hypothesis is that TaTME will result in a better mesorectum specimen quality~     with a lower rate of involved CRM and therefore lower rate of local recurrence. Furthermore,~     the TaTME procedure will potentially enable more sphincter saving procedures and will have~     positive effect on functional outcome and health related quality of life.~   "
63410|NCT02736929|"~     Some individuals who are exposed to traumatic events experience both psychological and~     cardiovascular changes that affect their health and well-being. The purpose of this study is~     to learn more about how reducing the psychological symptoms (such as those that occur with~     posttraumatic stress disorder, or PTSD) affects cardiovascular systems that regulate heart~     and blood pressure.~   "
63411|NCT02736916|"~     Prophylactic cranial irradiation (PCI) is an important treatment modality of patients with~     limited stage small cell lung cancer (LD-SCLC). However, PCI is also associated with several~     side effects, such as decline in memory and other cognitive functions. This provides the~     rationale to explore the clinical feasibility of hippocampal avoidance during WBRT. Previous~     studies have demonstrated the dosimetric capabilities of IMRT to conformally avoid the~     hippocampus without detriment to the radiation dose the remaining brain receives. The aims of~     this study is to evaluate the therapy efficacy and the safety profile of hippocampal-sparing~     whole-brain radiation therapy (HS-WBRT) for PCI in patients with LD-SCLC.~   "
63412|NCT02736903|"~     Despite the racial disparities in rates of chronic diseases and behaviors linked to chronic~     diseases, there have been relatively few RCTs of interventions to increase physical activity~     in African American women. Although some studies found significant improvement on physical~     activity, most focused on individuals and did not take into consideration the social contexts~     in which the participants' behaviors occurred. Understanding how online social networks~     facilitate behavior change can bridge important gaps in the way technology can be used to~     intervene on health among underserved populations. The primary objective of this study was to~     test the efficacy of a mobile app (PennFit) intervention in increasing participants' daily~     active minutes objectively recorded by a fitness tracking device (Fitbit zip). In the control~     group, participants used the PennFit app to record and monitor their own physical activity~     progress. In the online social network intervention, participants were randomized to 4-women~     networks and were able to see and compare their own recorded physical activities with~     activities of the other three women in their network. Participants in a network had access to~     an online chatting tool to chat with one another. The secondary objective was to understand~     the intervention's mechanisms through mediation analysis on theoretical variables.~   "
63413|NCT02736890|"~     Back pain is a common secondary condition of both acute and chronic spinal cord injury (SCI).~     Current existing treatment including both pharmacologic and non-pharmacologic are limited by~     marginal efficacy or intolerable side effects. The purpose of this study is to evaluate the~     potential of subcutaneous injections of botulinum toxin A to provide pain relief in spinal~     cord injury patients with back pain near the level of injury in the spine. Botulinum toxin A~     has been shown in both pre-clinical and clinical studies to help with nerve pain. The~     researchers propose a double blinded placebo controlled crossover study to study the effects~     of subcutaneous botulinum injections to at--level SCI back pain in patients with spinal cord~     injury.~   "
63414|NCT02736877|"~     The investigators will evaluate 30 patients with surgical indication for corneal~     transplantation. Participants will be divided according to the following diseases diseases:~     keratoconus, bullous keratopathy, corneal dystrophies. Participants will be informed about~     the risks and benefits of the study and sign an informed consent form. In the preoperative~     evaluation will be submitted to a complete ophthalmologic examination with complementary~     tests, such as optical coherence tomography.~      One group of participants will undergo corneal surgery using the OCT Lumera microscope RESCAN~     - ZEISS and another group with a conventional microscope. Everyone will have their filmed and~     documented surgery. The team of surgeons will answer the questionnaire on the surgical~     difficulty about the ease of assessing corneal transplantation. After surgery, participants~     will be assessed on days 1, 7,15, 30, 60, 90 and 180 after surgery.~      Surgeries and study procedures will be performed by the same team of surgeons and performed~     by IPEPO - Paulista Institute of Studies and Research in Ophthalmology / Vision Institute.~   "
63415|NCT02736864|"~     The study assesses patients with cured pulmonary tuberculosis by compulsory notification data~     of Uberlândia (Minas Gerais state - Brazil) from 2012, 2013, 2014 and 2015. These patients~     will be invited by telephonic contact. After eligibility and exclusion criteria evaluation,~     those included will be assessed in order to know structural and functional repercussions of~     pulmonary tuberculosis sequelae.~   "
63416|NCT02736851|"~     The aim of the study is to investigate if a home-based structured physician-directed,~     nurse-managed telemedicine program can increase adherence to a home exercise program and~     decrease neck pain and disability.~      The study is carried out in 100 consecutive patients with chronic non-specific neck pain.~      All patients referred to a rehabilitation Institute for an out-.patient visit complete a~     stretching exercise program and are instructed and encouraged to perform exercises regularly~     once at home. At the end of the rehabilitation, the patients are randomized into two groups~     of 50 patients each. Patients of the first Group are allocated to a home-based telemedicine~     (HBT), while those of the second group receive only the recommendation to continue exercising~     at home (Control group). The HBT intervention consists of fortnightly scheduled phone calls~     to patients over the 6-month course of the study. A nurse-tutor encourages the patient to~     perform regularly physical activity and prescribes exercises.~      Adherence to home exercises is evaluated 15 days and 6 months after the end of the outpatient~     rehabilitation, while pain intensity and neck disability are assessed and compared in the two~     groups at entry and 6 months after the end of the outpatient rehabilitation .~   "
63417|NCT02736838|"~     Objectives: 1. To analyze the changes in peripheral tissue oxygenation in tissues subjected~     to different pressure regimes in healthy humans. 2. To analyze changes in microvascular flow~     in peripheral tissues subjected to different pressure regimes in healthy humans. 3. To~     determine thresholds of tissue perfusion flow and transcutaneous oxygen depending on exposure~     levels and angling pressure in healthy volunteers. 4. To evaluate the distribution of tissue~     perfusion flow and transcutaneous oxygenation in real clinical situations in residential care~     and acute hospital care in patients at risk for impaired skin integrity.~      Methodology:~      Experimental non-controlled, non-randomized study in two phases: preclinical and clinical.~     The first phase, will be conducted in healthy volunteers and the second, in patients at risk~     for impaired skin integrity. Vascular flow, tissue oxygenation and local temperature in areas~     at risk of pressure ulcers by Doppler laser will be evaluated in subjects lying on a~     capacitive surface to measure pressure with 10,249 points of measurement, which will be~     subject to different body systems to generate different levels of pressure and monitor~     changes in tissue perfusion and oxygenation up to 4 hours, to know the implications for~     repositioning interventions in patients at risk.~   "
63418|NCT02736825|"~     Up to 260 subjects presenting with skin laxity on the face and neck will be randomized to one~     of two treatment groups. Subjects meeting all entrance criteria will receive study treatment,~     then complete two post treatment phone contacts and follow-up study visits at 90, 180 and 365~     days post treatment. Study images will be obtained pre-treatment, immediately post-treatment,~     and at each follow-up visit for qualitative and quantitative assessments of efficacy.~   "
63419|NCT02736812|"~     In severe bleeding due to trauma, a fall in coagulation factors maintains and promotes~     bleeding. The plasma allows, through its contribution of coagulation factors, early~     prevention or correction of this post-traumatic coagulopathy. The main objective is to show~     the effectiveness of pre-hospital administered FLYP during treatment of a traumatic~     hemorrhagic shock, in the occurrence or the treatment of a post traumatic coagulopathy.~      Study Design~      This is a Randomized controlled multicenter open study in two parallel groups. Eligibility~     criteria : adult, victim of a hemorrhagic shock of traumatic origin with [systolic blood~     pressure <70 mmHg] or [systolic blood pressure between 71 and 90 mmHg AND heart rate > 108],~     or Shock Index >1.3 at some point in the medicalized care. Two groups of 70 patients will~     receive either FLYP+ the usual treatment for post traumatic hemorrhagic shock as given in the~     recommendations for best practice, or saline perfusion but no FLYP, as given in the~     recommendations for best practice. The primary endpoint is the variation in the level of~     Prothrombin (PR), between the PR at hospital admission and the PR originally taken in the~     pre-hospital period.- The secondary endpoints are: compilation of technical and logistical~     difficulties encountered before, during and after administration of FLYP ; the change in~     fibrinogen level between fibrinogen level at hospital admission and fibrinogen level~     originally taken in the pre-hospital period. The study must confirm the link between~     causality of early administration of plasma in improving post-traumatic coagulopathy. The~     study must show safe usage in out-of-hospital situations and the ability of medical staff to~     meet the requirements of the health authorities in terms of product use as well as in terms~     of traceability of the victims and the treatment they received.~   "
63420|NCT02736799|"~     The Vibrant capsule is a novel vibrating device for the treatment of gastrointestinal~     disorders. The effect of different vibrations on the motor functions of the gastrointestinal~     tract are unclear. The study will focus on the stomach in healthy volunteers.~      The study will compare the effects of Vibrant capsule treatment and Sham capsule treatment on~     gastric emptying and gastric motility in healthy volunteers.~   "
63463|NCT02736240|"~     The purpose of this study is to investigate and valuate the immunogenicity and safety of the~     13-valent pneumococcal polysaccharide conjugate vaccine in 2-71 months old healthy infants~     and toddlers (the youngest could be 6 weeks old)~   "
63421|NCT02736786|"~     This study is an observational study evaluating the clinical outcomes of mucosal sparing~     proton beam therapy (PBT) after resection of favorable risk oropharyngeal cancer patients.~     Subjects will be screened at outpatient clinic visit appointments and interested qualified~     subjects will be consented and offered participation in this study. Once consent has been~     obtained baseline adverse event and Quality of Life (QOL) data will be collected and subjects~     will undergo adjuvant PBT and follow-up at 3 months, 12 months, and 24 months. No~     study-specific visits or evaluations will be required. Patients will be evaluated according~     to the physician's standard practice and discretion. Patient data will be drawn from the~     patients' medical records and reported by means of a web-based electronic data collection~     (EDC) system. Patients will be considered on study until 24 months of observation has~     occurred, withdrawal of consent, lost to follow-up, or study closure.~   "
63422|NCT02736773|"~     The aim of this study is to evaluate the volume of madibular bone after placement of a~     xenograft in a fresh extraction socket in human. The surgery protocol is flapless, and the~     teeth are mandibular premolars or molars leaving sockets with 4 walls intact or at least 3~     walls intact and the buccal wall at 80% . This study will include 35 patients.~      In addition, as part of this research, the investigators will retrospectively include 30~     controls. These Witnesses will be included retrospectively after having obtained their no~     opposition for the use of their data, it is about patients who present a tooth of the~     mandibular sector posterior to extract but who did not wish or did not have could have~     filling The inclusion of controls, will allow the validation of the evolution of the~     post-extracural bone volume after apolar filling~   "
63423|NCT02736760|"~     This study is a multicenter study investigating the clinical efficacy of repetitive~     daylight-PDT with MAL (Methylaminolevulinate) compared to cryosurgery in regard to~     prophylaxis and treatment of AKs (actinic keratoses) in the face. Patients will be randomly~     allocated to treatment groups. 5 PDT (photodynamic therapy) treatment sessions (visits 1-5)~     will be performed within 18 months. In the control group, cryosurgery will be performed at~     visit 1, and in case of non-cleared or newly occurred AKs at visits 2-5.~      In the PDT group the patients will apply a chemical sunscreen (SPF 50+) to the whole face and~     other light-exposed, unprotected areas of the skin. After at least 15 minutes a lesion~     preparation of AKs (removal of crusts) will be performed and MAL will be applied in a thin~     layer to the whole face. Within 30 min after MAL application patients expose themselves to~     daylight for 2 hours. In the control group, cryosurgery will be performed using liquid~     nitrogen spray in each AK lesion; this will be done at visit 1 and, if necessary, also at~     visits 2-5. At visits 2-6, the efficacy of the treatment will be evaluated by the observer by~     documenting all existing and newly appearing AKs in the face.~   "
63424|NCT02736747|"~     The stroke has been described as the third cause of death and main cause of disability in the~     worldwide population. About 60% of the survivors are able to walk following the~     rehabilitation process, however deficits on lower limbs functions often persists in most~     cases, affecting the gait and functional mobility. In this sense, several interventions are~     applied in the clinical practice to optimize the functional performance. Cryotherapy is one~     of the most used techniques aiming to reduce spasticity temporarily, allowing the training of~     functional tasks, such as walking. The aim of the present study is to evaluate the immediate~     effects of cryotherapy (ice pack) on neuromuscular performance, proprioception, passive~     resistance of dorsiflexors and plantarflexors muscles, and also on gait performance in~     chronic post-stroke subjects. Eighteen chronic hemiparetic subjects will participate in this~     crossover placebo-controlled trial. The order of intervention (cryotherapy or placebo) will~     be randomized. Fifteen days of washout period will be considered. The cryotherapy/placebo~     will be applied on the posterior area of the leg for 20 minutes. Initially Fugl Meyer will be~     applied. All other assessments will be performed before and after intervention: spasticity~     level, classified according to Modified Ashworth Scale; temporo-spatial and angular~     parameters for trunk, hip, knee and ankle during gait, using a motion analysis system~     (Qualysis AB, Gothenburg, Sweden); the proprioception (joint position sense), passive~     resistance to stretching, isometric and isokinetic torques during contractions of~     plantarflexors and dorsiflexors of the ankle, evaluated through isokinetic dynamometer.~     Concomitantly, bilateral activation of soleus, gastrocnemius, tibialis anterior and peroneus~     will be assessed by electromyography during isokinetic dynamometer assessment and gait. The~     following electromyographic variables will be analyzed: maximum activation amplitude, muscle~     onset, coactivation index between agonists and antagonists. For statistical analysis,~     normality (Shapiro Wilk) and homogeneity (Levene) tests will be applied. If the variables~     have a distribution considered normal and homogeneous, Two-way ANOVA with repeated measures~     will be applied. Otherwise, non-parametric statistics (Friedman test) will be applied. A~     significance level of 0.05 will be considered for all statistical tests.~   "
63425|NCT02736734|"~     Stress is well known to affect visceral sensitivity and gastrointestinal function in general.~     A majority of patients with gastroesophageal reflux disease (GERD) report stress as an~     important factor triggering symptom exacerbation. A real-life stressor could exacerbate~     heartburn symptoms in GERD patients by enhancing perceptual response to esophageal acid~     exposure. In Irritable Bowel Syndrome (IBS) patients, visceral hypersensitivity is a major~     pathophysiological mechanism and stress is shown to trigger or exacerbate symptoms.~      A possible mechanism of stress−induced visceral sensitivity could be the barrier dysfunction.~     Indeed, in a study performed by our group, in human, an acute psychological stressor induces~     hyperpermeability in a mast cell dependent fashion and exogenous peripheral~     corticotrophin-releasing hormone (CRH) recapitulated its effects on barrier function. This~     increase in intestinal permeability is a phenomenon which appears as a prerequisite for~     visceral hypersensitivity. Furthermore, few studies indicate that human intestinal motility~     is probably modulated by CRH. It has been shown that the brain-gut axis in IBS patients has~     an exaggerated response to CRH.To our knowledge, the acute effect of exogenous CRH on~     esophageal motility has not been studied before.~   "
63426|NCT02736721|"~     This study will evaluate the efficacy, safety and tolerability of long-term use of~     peginterferon alfa-2a in participants with CML who have previously participated in~     peginterferon alfa-2a study ML16544 (NCT number not available), NO16006 (NCT number not~     available) or ML17228 (NCT number not available) and treating physician has decided to~     continue treatment with peginterferon alfa-2a within the frame of another clinical study.~   "
63427|NCT02736708|"~     Primary sclerosing cholangitis (PSC)~        1. Prospectively validate interpretation criteria for the characterization of PSC~          strictures~        2. Prospectively evaluate the accuracy of pCLE for the characterization of PSC strictures~          (differentiation between malignant vs. non malignant strictures), using the newly~          developed interpretation criteria~        3. Evaluate the feasibility and safety of pCLE for the characterization of PSC strictures~   "
63428|NCT02736695|"~     This study is designed to learn more about overall tau burden in the brain of patients with~     Primary Progressive Aphasia (PPA).~   "
72946|NCT02612155|"~     This study will test the safety and efficacy of an infusion of a baby's own (autologous)~     umbilical cord blood as compared with placebo in babies born with history and signs of~     hypoxic-ischemic brain injury.~   "
63429|NCT02736682|"~     Delivery by Cesarean section is increasing worldwide and this is the most important risk~     factor for post partum infection where there is a 5-20% risk of developing post partum~     infection than women who deliver vaginally Provision of single dose broad spectrum~     intravenous antibiotics 30-60 minutes before cesarean section has been found to be as~     effective as multiple doses in reducing post operative infections. At Mulago National~     referral Hospital mothers who have had elective and are at low risk of post partum infection~     also receive multiple doses of intravenous antibiotics for up to 7 days. The rationale of the~     study is to further inform us that single dose preoperative antibiotic prophylaxis is~     effective in prevention of post operative infection in mothers delivered by elective cesarean~     section.~   "
63430|NCT02736669|"~     This research study will compare two weight loss programs that provide different~     recommendations for how to reduce your energy (or calorie) intake to achieve weight loss in~     an effort to determine if fixed calorie reduction or varied calorie reduction is more~     effective for weight loss.~   "
63431|NCT02736656|"~     This is a multicenter, open-label extension study aimed to assess long-term safety and~     efficacy of SPN-812 ER when administered alone or in conjunction with an Food and Drug~     Administration-approved Attention Deficit Hyperactivity Disorder (ADHD) medication in the~     treatment of ADHD in pediatric subjects who have participated in a previous blinded study of~     SPN-812 ER. All pediatric subjects who complete a blinded study of SPN 812 ER will have the~     option to participate in this study in which all subjects receive SPN-812 ER. After an~     initial dose, subjects will enter an dose optimization phase for three to nine weeks.~     Following optimization, subjects will return to the clinic every 3 months or until the~     subject discontinues or the study ends at 36 months.~   "
63432|NCT02736643|"~     Lung cancer is one of the leading causes of cancer-related death in Taiwan. Early diagnosis~     of lung cancer may improve cancer survival. Low-dose computed tomography (LDCT) was thought~     to be the best screening tool for lung cancer. However, there is growing concerns about~     radiation exposure, high cost, and high rate of false-positive screening result. Epidemiology~     data for LDCT screening in Taiwan is lacking.~      National Taiwan University Hospital Chu-Tung Branch (NTUHCT) initiated the lung cancer~     screening by LDCT since June 2015. Many people can get the LDCT screening with affordable~     price with the subsidy from enterprise donation. The purpose of this study is establishing~     local epidemiological result via telephone follow-up and patients' medical records~     retrospectively.~   "
63433|NCT02736630|"~     Primary objective of the study is to project the incidence rate of perioperative hypothermia~     under general anesthesia in patients who go under minimum 1 hour long elective surgery in at~     least 25 hospitals/medical centers in Turkey .~      Secondary objectives are to determine the patient risk factors associated with perioperative~     hypothermia, to determine the surgery risk factors associated with perioperative hypothermia,~     to determine the other risk factors associated with perioperative hypothermia, intraoperative~     infusion volume and effect of warming, intraoperative irrigation volume and effect of~     warming, intraoperative blood infusion volume and effect of warming, to determine~     complications related to perioperative hypothermia, to improve patient temperature management~     awareness and processes.~   "
63434|NCT02736617|"~     This phase II trial studies how well obinutuzumab works in combination with ibrutinib in~     treating patients with mantle cell lymphoma that has returned (relapsed) or that does not~     respond to treatment (refractory). Obinutuzumab binds to a protein called cluster of~     differentiation (CD)20, which is found on B cells and some types of leukemia and lymphoma~     cells and help the immune system kill cancer cells. Ibrutinib blocks a protein called~     Bruton's tyrosine kinase (BTK), which may help keep cancer cells from growing. Giving~     obinutuzumab in combination with ibrutinib may kill more cancer cells.~   "
63435|NCT02736604|"~     Postoperative nausea and vomiting (PONV) is considered one of the most unpleasant~     postoperative discomforts and lead to serious complications of aspiration of gastric~     contents, suture dehiscence, esophageal rupture, subcutaneous emphysema, or pneumothorax. The~     incidence of PONV is 30-40% in normal population and touches a peak of 75-80% in certain~     high-risk groups. PONV is associated with delayed recovery and prolonged hospital stay and is~     associated with significant morbidity. It may also result in delayed discharge, which is~     particularly significant after potentially ambulatory surgery. Women are 2 to 3 times more~     susceptible to PONV than men and breast surgery, which is primarily done in an outpatient~     setting, is associated with high incidence of PONV, ranging between 15% and 84% in the~     absence of prophylactic treatment.~      Nitrous oxide (N2O) has analgesic and sedative properties but may potentially increase the~     incidence of PONV. N2O might increase the incidence of PONV by several potential mechanisms:~     (1) increase in middle ear pressure (2) bowel distension, (3) activation of the dopaminergic~     system in the chemoreceptor trigger zone and (4) interaction with opioid receptors. N2O has~     been demonstrated to increase the incidence of PONV in some studies but not in others. The~     present study is undertaken to evaluate the effect of nitrous oxide- free general anesthesia~     on the undesirable clinical outcome of PONV.~   "
63436|NCT02736591|"~     300 women with expected poor ovarian response (POR) undergoing in vitro fertilization or~     intra-cytoplasmic sperm injection (ICSI) will be randomly divided into 2 equal groups using~     computer generated random numbers. Group 1 will receive Dehydroepiandrosterone (DHEA) 25 mg (~     DHEA 25mg, Natrol , USA) t.d.s daily for 12 weeks before starting IVF/ICSI cycle and a~     placebo similar to growth hormone (GH) daily from day 6 of stimulation until the day of human~     chorionic gonadotrophin (hCG) trigger. Group 2 will receive an oral placebo t.d.s. daily for~     12 weeks before ICSI in addition to GH (Somatotropin, Sedico, Egypt) 4 IU on day 6 of hMG~     stimulation in a daily dose of 2.5 mg subcutaneous (SC) until the day of hCG triggering.~      Patients included in the study will be subjected to full history taking and clinical~     examination. On the second day of menstruation serum FSH, LH, Prolactin and Oestradiol will~     be assessed and the antral follicular count (AFC) will be assessed using a vaginal ultrasound~     scan. AFC will be defined as the number of follicles measuring 3-10mm.~      All patients will have gonadotropin antagonist protocol with Human menopausal gonadotrophin~     (hMG) stimulation until the day of hCG administration. On the day of hCG administration,~     ovarian ultrasound scan will be performed using a transvaginal probe. Oocytes will be~     aspirated 34-36 hours after HCG administration. Oocytes will be fertilized and embryos will~     be transferred. Both groups will be compared regarding the proportion of ongoing pregnancy.~   "
63438|NCT02736565|"~     Ewing's sarcoma characterized by the t(11; 22) (q24; q12) translocation at several but~     prioritized breakpoint sites, resulting in the EWS/FLI1 fusion gene is the second most~     frequently diagnosed primary malignant bone tumor in the US with an annual incidence, from~     birth to age 20, of 2.9 cases per million population. The survival rate for patients with~     high-risk recurrent disease (relapse < 2 years) is < 10% at 5 years. Moreover, of patients~     who progress after second line treatment, eighty percent do not achieve a second complete~     response and of these patients < 10% survive one year. Refractory patients to both frontline~     and second line therapy have even worse prognosis.~      The EWS/FLI1 gene is well known as the driver gene of Ewing's sarcoma. We designed a novel~     pbi-shRNA™ EWS/FLI1 Type 1 LPX which has demonstrated sufficient specificity, safety and~     efficacy in animal testing to justify Phase I testing. Clinical safety (no ≥ grade 3 product~     related toxic effect) and target specific activity has been observed with other bi-shRNA~     products involving 147 cancer patients (698 separate dose administrations) (BB-IND 14205;~     BB-IND 14938). Moreover, safety has been observed with IV delivery of pbi-shRNA™ EWS/FLI1~     Type 1 LPX in murine and swine testing via multidose IV administration.~      Study testing of pbi-shRNA™ EWS/FLI1 Type 1 LPX will involve patients (≥age 8) with advanced~     Ewing's sarcoma. The first 3 subjects enrolled onto the study as well as the first subject~     enrolled into each dose cohort must be 16 years of age or older. pbi-shRNA™ EWS/FLI1 Type 1~     LPX will be given via intravenous infusion twice a week for 4 weeks (e.g. Mon and Thurs,~     preferred) for a total of 8 infusions of the product per cycle followed by a 2 week washout~     period. Patients will be accrued in 3-patient dose escalation cohorts using the following~     escalation schema (50% to 33% to 25% to 25% to 25%) at a starting IV dose of 0.04 mg/kg.~   "
63439|NCT02736552|"~     The study aims to compare the efficacy and safety of S-1 for 6 months versus S-1 for 1 year~     as adjuvant chemotherapy after D2 resection in patients with gastric cancer.~      Hypothesis: For gastric patients after D2 resection, S-1 for 6 months shows non-inferiority~     to S-1 for 1 year in disease free survival(DFS), overall survival (OS) and safety.~   "
63440|NCT02736539|"~     This study is designed as a randomized double-blinded treatment trial among travelers' to~     geographical areas with moderate-severe rates of traveler's diarrhea. Travelers will be~     randomized to receive CBS 2004 or masked placebo to be taken daily while traveling. The test~     article or placebo will be taken starting 7 days prior to travel.~   "
63441|NCT02736526|"~     The purpose of this study is to determine the long-term effect and security of the surgical~     treatment and observation only on ocular alignment, binocular stereopsis, and quality of life~     in children with moderate intermittent exotropia.~   "
63442|NCT02736513|"~     Patients will receive AZD9291 at a dose of 80 mg once daily. Intracranial response will be~     assessed with brain MRI scan, systemic evaluation will be done by PET-CT scan.~      In case of isolated CNS progression which may or may not be accompanied by asymptomatic~     systemic progression, AZD9291 dose will be escalated to 160 mg once daily. For patients whose~     intracranial disease will progress further, brain radiotherapy (in the form of SRS or WBRT)~     will be administered; treatment with AZD9291 will be interrupted and re-initiated at a~     standard dose after the end of radiotherapy course in the absence of symptomatic systemic~     progression. The treatment will be continued until symptomatic systemic progression,~     unacceptable toxicity or further intracranial progression following brain radiotherapy~     administration (whichever occurs first). All patients will be followed until death or 5~     years.~   "
63443|NCT02736500|"~     The aim of this phase I-II study is to evaluate the efficacy and toxicity of PRRT with~     177Lu-DOTATATE (Lu-PRRT) associated to metronomic chemotherapy with Capecitabine in patients~     affected by aggressive FDG-positive gastro-entero-pancreatic NET. Moreover to analyze the~     effects of the capecitabine metronomic schedule on the level of circulating angiogenetic~     factors.~   "
63444|NCT02736487|"~     The purpose of this research project is to examine whether short-term use of portable air~     pollution filtration can result in changes in indoor airborne pollutants and impact on~     cardiovascular and respiratory health outcomes of the inhabitants.~   "
63445|NCT02736474|"~     The purpose of this research is to observe the efficacy of Naltrexone and Bupropion~     combination on weight loss and smoking cessation from baseline to week 24 compare to placebo.~   "
63446|NCT02736461|"~     In patients suffered from floor fractures, there are 21.9% complaining about diplopia before~     fracture repair surgery and 20.8% after operation. Even after 6 months, there still are 16.4%~     had similar conditions. Investigators are planned to find predicting factors to prevent such~     conditions from happening.~   "
63447|NCT02736448|"~     This is a randomized phase II, parallel group study. Patients with gastro-entero-pancreatic~     neuroendocrine tumors (GEP-NET) well differentiated G1 - G2 (ki67≤ 20%) and G3 (ki67≤ 50%),~     somatostatin receptor (SSR) positive and 18-FDG positive will be enrolled in the study and~     will be randomly assigned to 2 different arms:~        -  Arm Lu-PRRT-Cap: oral low dose of capecitabine in association with Lu-PRRT (at 3.7 Gbq~          per cycle x 7 cycles) followed by long acting octreotide or lanreotide (SS-LAR); OR~        -  Arm Lu-PRRT: Lu-PRRT (at 3.7 gigabecquerel (Gbq) per cycle x 7 cycles) followed by~          SS-LAR.~   "
63448|NCT02736435|"~     The purpose of this study is to demonstrate the effectiveness of MR-HIFU for the treatment of~     uterine fibroids in Northwestern Ontario, which is a rural and remote setting.~   "
63449|NCT02736422|"~     Hyperpolarised gas Magnetic resonance imaging (MRI) (Hyperpolorised 3He and 129Xe MRI)~     provides novel regional functional images of the lungs. Over the past 14 years researchers at~     Sheffield Teaching Hospitals NHS Foundation Trust and University of Sheffield have been~     developing and evaluating different MRI techniques to investigate different aspects of the~     lung function with both Hyperpolorised 3He and more recently 129Xe gas and have tested these~     new methods in volunteers with healthy and diseased lungs. This proposed study is to further~     test the sensitivity of MRI pulse sequences with inhaled 129Xe gas in volunteers. This~     protocol serves to evaluate the sensitivity of pulse sequences for 129Xe magnetic resonance~     imaging in the lungs and monitoring the transient changes in vital signs during and following~     the gas inhalation. This includes evaluation of pulse sequences to image xenon in the heart~     and brain as well as in the lungs of volunteers.~   "
63450|NCT02736409|"~     This is a multicenter, double- blind extension study of Oral Budesonide Suspension (OBS) in~     adults and adolescents (11 to 55 years of age, inclusive) with Eosinophilic Esophagitis (EoE)~     who have completed participation in the SHP621-301 induction study (NCT02605837). The primary~     objective is to evaluate the maintenance of efficacy of OBS over 36 weeks. Maintenance of~     efficacy will be measured by the peak eosinophilic count and Dysphagia Symptom Questionnaire~     (DSQ) score.~   "
63451|NCT02736396|"~     The study objective is to correlate global cognition and episodic memory performance to~     resting state fMRI functional connectivity. This is a non-treatment, prospective, natural~     history data collection study in a cross-sectional cohort of patients with cognitive~     impairment.~   "
63453|NCT02736370|"~     The purpose of this observational study is to assess the rate of return to work, rate of~     return to activities, functional outcome measures and pain scores in operatively repaired~     rotational Bimalleolar and Trimalleolar (AO/OTA Classification of 44A and 44B) ankle~     fractures not requiring fixation of the syndesmosis and allowed early weight bearing on or~     before the first post-operative visit.~   "
63454|NCT02736357|"~     The goal of this infrastructure grant is to establish and maintain a cohort of over 12,000~     non-Hodgkin lymphoma (NHL) patients to support broad and cutting-edge research that~     identifies clinical (including co-morbid diseases), epidemiologic (including lifestyle and~     other exposures), host genetic, tumor, and treatment factors, as well as the interaction~     among these factors, on short and long-term outcomes. These efforts will identify new~     approaches to improve the survival and well-being of NHL patients.~   "
63455|NCT02736344|"~     The BioNIR Ridaforolimus Eluting Coronary Stent System is a single use device/drug~     combination product comprising:~        -  Stent - mounted Cobalt Chromium (CoCr) alloy based stent~        -  Delivery System - Rapid Exchange (RX) Coronary System~        -  Polymer matrix coating - Poly n-butyl methacrylate (PBMA) and polymer coating~          (CarboSil®)~        -  Ridaforolimus drug - Chemical Abstracts Service (CAS) Registry Number: 572924-54-0 The~          product is indicated for improving coronary luminal diameter in patients with~          symptomatic heart disease due to lesions in vessels with reference diameters of 2.5mm to~          4.25mm, including complex lesions.~   "
63456|NCT02736331|"~     Primary objective is to assess the effect of the intake of different types of fruits on~     memory and attention.~      Secondary objective is to assess effect of intake of different types of fruits on metabolic~     markers, including glucose, insulin, total cholesterol and triglyceride and the~     pharmacokinetic profile of the anthocyanins.~   "
63457|NCT02736318|"~     Treatment of osteochondral lesion of Talus with a devitalized viro-inativated sterile~     osteochondral graft. To avoid having to harvest autograft material from the knee, a processed~     allogeneic osteochondral can be used instead autograft. The surgical technique is to implant~     in the osteochondral defect one to three products in the defect.~   "
63458|NCT02736305|"~     Regorafenib is an oral multikinase inhibitor that blocks the activity of kinases involved in~     angiogenesis (VEGFR 1,2,3 and TEK), oncogenesis (KIT, Ret Proto-Oncogene (RET), Raf-1~     Proto-Oncogene, Serine/Threonine Kinase (RAF1) and BRAF) and tumour growth (PDGFR and FGFR).~     Epithelial ovarian cancer (EOC) cell lines frequently express high levels of vascular~     endothelial growth factor (VEGF) and in vivo preclinical studies evaluating Regorafenib have~     shown promising activity in ovarian cancer. In the clinic, anti-angiogenesis therapy with~     bevacizumab (a monoclonal antibody to VEGF) has already emerged as an important cornerstone~     in the management of ovarian cancer both as part of frontline adjuvant treatment and as~     second-line therapy for platinum-sensitive recurrent disease. Whilst Regorafenib has been FDA~     approved for the treatment of patients with metastatic colorectal cancer who have failed~     prior bevacizumab, it's role in the management of ovarian cancer remains to be defined.~   "
63459|NCT02736292|"~     A newly developed intervention, Mindfulness Based Practices for Health Care Professionals in~     Training: Clinical Applications, will be piloted to determine the feasibility, acceptability,~     accessibility, and preliminary effects within this population.~   "
63460|NCT02736279|"~     Objectives: Dimethyl fumarate (DMF) therapy may cause a measureable change in bacterial~     species of the gut. The primary objectives of this study are:~        1. Determine whether a measureable change in bacterial species representation follows the~          institution of DMF.~        2. Determine whether a specific pattern of change in the microbiota phylotype with DMF~          therapy correlates to onset and severity of gastrointestinal disturbances (heartburn,~          nausea, flatulence, and diarrhea).~        3. Determine whether any instability of microbiota phylotype representation persists~          following the institution of DMF or whether stabilization relates to resolution of~          gastrointestinal disturbances.~        4. Determine whether there is a correlation between a pre-existing functional bowel~          disorder and development or severity of gastrointestinal disturbances and of peripheral~          eosinophilia.~      Design: Double-blinded, prospective, single-center pilot study.~      Patient Population: Individuals 18 years or older, with a confirmed diagnosis of a relapsing~     form of multiple sclerosis.~      Treatment Groups: This study will be an open-label prospective study design with respect to~     MS immunomodulatory therapy choice. Study group will be defined as subjects with a relapsing~     form of multiple sclerosis, as defined by the McDonald criteria, choosing to begin DMF~     therapy.~   "
63461|NCT02736266|"~     Patients with T2-T4a N0 urothelial bladder carcinoma (UBC) with residual disease after~     transurethral resection of the bladder (TURB, surgical opinion, cystoscopy or radiological~     presence) will receive 3 cycles of pembrolizumab (MK-3475) at the dose of 200mg 3 weekly~     prior to surgery (radical cystectomy). Cystectomy will be planned to be done within 3 weeks~     of the last dose (accounting for a total of 9 weeks).~      Computed tomography (CT) scan and fluorodeoxyglucose positron emission tomography~     (FDG-PET)/CT scan will be done during screening and before surgery. After cystectomy,~     patients with the evidence of pathologic stage T3-4 (pT3-4) and/or pathologically~     node-positive disease will be managed according to local guidelines. Further anti~     programmed-death (PD)-1 or anti PD-ligand 1 (PD-L1) therapy will not be given~     post-operatively.~      PD-L1 status will be centralized and assessed on TURB specimen using an anti-PD-L1 antibody~     (Ab) and a prototype immunohistochemical (IHC) assay. PD-L1 positivity will be defined as any~     staining in the stroma or in ≥1% of tumor cells.~      Pathologic complete response (pCR) is the primary endpoint. All patients enrolled who receive~     at least 1 cycle of study drug will be includes in the intention-to-treat (ITT) analysis.~      The alternative hypothesis (H1) is pCR ≥20% and null hypothesis (H0) pCR≤10%. A 2-stage~     design will be used to estimate the number of pts required. Out of 90 pts overall, with the~     first stage of 49 pts, ≥6 pCR will be required in the first stage, and ≥13 pCR in the whole~     study population (80% power and a 2-sided test of significance at the 10% level).~      Correlative research on tissue/blood samples will include immune-cell profiling in tumor and~     blood during Pembrolizumab, cytokine assessment, and molecular profiling of tumor samples.~   "
63462|NCT02736253|"~     In this study, it was aimed to evaluate the independent risk factors for osteomyelitis,~     amputation and major amputation of the diabetic foot infection in the forward direction~     without using standard scoring procedures.~   "
63464|NCT02736227|"~     Most patients who get a liver transplant must take immunosuppressants for the rest of their~     lives. However, this has occurred at the expense of chronic CNI toxicity, e.g. chronic kidney~     disease (CKD), metabolic complications, infections and malignancy. Everolimus (EVL) is a drug~     that may stabilize or improve kidney function for patients with chronic kidney disease (CKD)~     that has been caused by immunosuppressants. EVL is used for standard of care treatment to~     prevent transplant liver rejection in combination with other immunosuppressants, such as~     tacrolimus. The overall aim of this study is to examine a combination of two different~     immunosuppressants and EVL to determine if patients may have stabilized and/or improved~     kidney function without liver rejection. This study will look at how safe it is to slowly~     withdraw one anti-rejection medication while continuing to take the other medicine, and~     whether this can be done without liver rejection occurrence.~   "
63465|NCT02736214|"~     Many women and men in fertile age are at risk for sexual transmitted infections and unwanted~     pregnancies, and have insufficient knowledge of health promoting lifestyle prior to~     conception. There is a need to increase awareness among people in fertile age about how~     sexual risk-taking and unhealthy lifestyle can negatively affect fertility and pregnancy~     outcomes. Previous studies on preconception health and care have mainly focused on women. The~     aim of our study was to investigate if Reproductive Life Plan-based counseling with a midwife~     could increase men's reproductive knowledge. The second aim was to evaluate men's experiences~     of the intervention.~   "
63466|NCT02736201|"~     Objective: To determine the effectiveness of the capacitive diathermy in the~     mechanosensitivity, morphological, functional and contractility changes in patients with~     lumbopelvic pain.~      Design: A pilot study, single blind, randomized controlled clinical trial, approved~     previously by The Princess University Hospital Ethics Committee (Feb 11, 2016) and the~     European University clinical intervention review board (CIPI/054/15).~      Setting: Faculty of Health Sciences, Exercise and Sport. European University of Madrid.~      Patients and intervention: A sample of 20 patients with bilateral lumbopelvic pain, between~     18 and 60 years old, will be recruited and randomized into 2 intervention groups. The~     instrumental manual therapy with the switched on capacitive diathermy electrode (IMT+~     T-CaRe®on; n = 10) and the instrumental manual therapy with the switched off capacitive~     diathermy electrode (IMT+ T-CaRe®off; n = 10) will be bilaterally treated for 4 weeks (1~     treatment per week during 10 minutes) in the lumbopelvic region.~      Outcome measurements: Control variables such as the age, sex, height, weight, body mass~     index, Borg scale physical activity and distress respiratory test will be measured at the~     beginning of the treatment. Dependent variables such as the pain intensity, the pressure pain~     threshold, the contractility, the stiffness, the adverse effects, the Oswestry and Schöber~     test, as well as the ultrasound imaging cross sectional area and thickness of the skin,~     subcutaneous tissue, connective tissue, L4 multifidus and the abdominal Wall (rectus~     anterior, externus oblique, internal oblique and transversus abdominis) will be assessed~     before and after each intervention by a blinded examiner.~      Analysis data: The statistical analysis will be performed with a 95% confidence interval and~     the Statistic Package Social Sciences (SPSS) 22.0.~   "
63467|NCT02736188|"~     This open-label extension study of Ace-ER will assess the long-term safety and efficacy of~     Ace-ER treatment over a period of 24 months. Approximately 165 subjects from the UX001-CL202,~     UX001-CL301 and UX001-CL203 studies will be eligible to enroll in the study.~   "
63468|NCT02736175|"~     The objective of the study was to evaluate the safety and efficacy of OTX-DP (dexamethasone~     insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the~     treatment of post-surgical inflammation and pain in subjects who had undergone cataract~     extraction with intraocular lens implantation~   "
63469|NCT02736162|"~     The primary objective of this study is to assess the retention rate of perampanel when given~     as secondary monotherapy in routine clinical care.~   "
63470|NCT02736149|"~     Ubenimex is being developed for the treatment of pulmonary arterial hypertension (PAH) (World~     Health Organization [WHO] Group 1) to improve exercise capacity and delay clinical worsening.~     This study is a Phase 2, open-label, multicenter, extension study to evaluate long-term~     safety and efficacy of ubenimex in patients with PAH (WHO Group 1) who complete Study~     EIG-UBX-001 (Study EIG-UBX-001 is a Phase 2, randomized, double-blind, placebo-controlled~     clinical trial) and meet the eligibility criteria for Study EIG-UBX-002. The primary~     objective for this study is:~      - to obtain long-term safety and tolerability data for ubenimex (150 mg administered three~     times daily [TID]) in patients with PAH (WHO Group 1).~   "
63471|NCT02736136|"~     This study aims to investigate the effects of an early intervention (joint observation and~     video feedback) on maternal parenting self-efficacy following a premature birth. Mothers who~     have given birth to a very premature baby will be randomly allocated to either the early~     intervention or usual care whilst the infant is still hospitalized. Participants will be~     followed up at one month and six months. It is predicted that participants who received the~     early intervention will report higher maternal parenting self-efficacy than those who are~     not.~   "
63472|NCT02736123|"~     This study plans to test the pathologic complete response (pCR) rate of the combination~     biotherapy regimen consisting of nivolumab plus ipilimumab versus nivolumab alone in patients~     with advanced but operable melanoma. Evaluation of the presence of tumor-infiltrating CD8+ T~     cells as well as that of PDL1 expression and IDO expression will be associated with clinical~     response (pathologic and/or radiologic). The study will test the radiologic/clinical~     preoperative response rate, recurrence free survival (RFS) and overall survival (OS). It will~     evaluate the safety of neoadjuvant nivolumab and neoadjuvant nivolumab-ipilimumab. Up to 66~     patients will be randomized in 1:1 ratio.~   "
63473|NCT02736110|"~     This registry study will compile information from patients that are scheduled to receive or~     have received Adipose Derived Regenerative Cells (ADRCs) prepared by the Celution device to~     treat osteoarthritis in the knee.~   "
63474|NCT02736097|"~     Recently clinical guidelines categorize pneumonia in to three types: community,~     healthcare-associated, and hospital-acquired. Much of the existing research to describe the~     epidemiology of pneumonia in critically ill patients comes from single-center studies or from~     retrospective database analyses, which limit generalizability and lead to over-prescription~     of broad-spectrum antibacterial agents. This will be a prospective, multicenter~     epidemiological study to characterize pneumonia epidemiology in critically ill adult~     patients.~   "
63486|NCT02735941|"~     The purpose of the study is to investigate phospholipid ligands and their receptors in~     inflammatory bowel diseases and colon cancer. Several new species of lipids have been~     recently discovered which are able to transmit information to cancer cells in the large~     intestine. The lipids and their responsive receptors build an axis that is thought to~     influence the development of inflammation and cancer.~   "
76240|NCT02569060|"~     The Feeding America Intervention Trial for Health—Diabetes Mellitus (FAITH-DM) is a~     randomized, controlled study of the implementation of a diabetes intervention in food pantry~     settings.~   "
63475|NCT02736084|"~     The investigators developed a novel, telephone-based, 12-week positive psychology~     intervention and will assess its feasibility and short-term impact in adults with type 2~     diabetes (T2D) and suboptimal health behavior adherence. Participants will receive a positive~     psychology (PP) manual, complete exercises (e.g., writing a gratitude letter, performing acts~     of kindness), and review these activities by phone with a study trainer over the 12-week~     study period.~      Specific Aim #1 (Feasibility and acceptability (immediate impact); primary aim): To assess~     whether PP exercises administered over the phone are feasible and linked with immediate~     benefit in patients with T2D, as measured by ratings provided pre- and post- each exercise.~      Hypothesis: The PP exercises will be feasible (i.e., 4 of the 7 PP exercises will be~     completed by a majority of participants, and participants will have a mean score of at least~     7 out of 10 on ratings of ease of completion for the exercises. The PP exercises will also~     have adequate immediate impact (i.e., mean ratings of 7/10 of exercise utility post-exercise~     and ratings of optimism post-exercise that are significantly higher than pre-exercise).~      Specific Aim #2 (Changes in clinical outcome measures): To determine whether the PP~     intervention is linked to improvements in psychological well-being, during and after the~     intervention period (6 & 12 weeks), via measures of optimism, gratitude, depression, and~     anxiety. To examine whether the brief PP intervention is associated with improvements in~     self-reported outcomes related to health (diabetes self-care, diabetes distress, health~     related quality of life), during and after the intervention.~      Hypothesis: Participants will have higher mean scores on all psychological outcome measures~     at 6 and 12 weeks compared to baseline. Participants will also have higher mean scores on all~     health-related outcome measures at 6 and 12 weeks compared to baseline.~   "
63476|NCT02736071|"~     Two hundred and ten women undergoing operative hysteroscopy will be randomly divided into~     three equal groups. To ensure blinding the double dummy technique will be used in which group~     1 will receive Tramadol 100mg orally in addition to a placebo similar to Celecoxib, group 2~     will receive Celecoxib 200mg in addition to a placebo similar to Tramadol, and group 3 will~     received a placebo similar to Tramadol in addition to a placebo similar to Celecoxib. All the~     drugs will be given 2 hour before the procedure. An independent person will generate the~     allocation sequence using computer generated random numbers.~      Patient's perception of pain will be assessed for each group during the procedure,~     immediately after and 30 min after the procedure with the use of visual analogue scale (VAS).~   "
63477|NCT02736058|"~     Reaching the proper pre-operative diagnosis for abnormal placentation in crucial to markedly~     decrease the intra-operative complications as well as the maternal morbidity and mortality.~     In this trial researchers aim to set up some pre-operative sonographic criteria that would~     help in planning the surgical procedure as well as setting up a surgical classification for~     the abnormally adherent placenta.~   "
63478|NCT02736045|"~     Prior research has demonstrated that during residency years, in particular training to obtain~     a medical specialty, work burnout is a very prevalent problem. Work burnout is defined as a~     syndrome of dysfunction in three domains, emotional exhaustion, depersonalization, and a~     reduced sense of personal accomplishment. (Maslach et. al., 1981). Often, burnout has been~     associated with poor sleep quality and negative affectivity, such as depression and anxiety.~     In fact, our preliminary data demonstrate that burnout in medical residents affects sleep~     quality, and increases negative emotions. Strikingly, burnout in medical residents negatively~     impacts working performance as well as patient-physician interactions, and hence may affect~     the quality of health care. However, lacking are studies aimed at understating how work~     burnout affects cognitive performance and decision making in medical residents. The proposed~     study will provide essential groundwork in demonstrating the link between burnout and~     impaired cognitive performance. In addition, the proposed study will demonstrate feasibility~     for a future trial to test whether an intervention, emWave, integrating a computer based~     stress management (resilience training), can have a positive impact on residents with high~     burnout symptoms. The amelioration of psychological risk factors in medical residents may~     lead to improved physician-patient relationships in the service of improved quality of care.~   "
63479|NCT02736032|"~     Traditionally, the use of GnRH-a suppression was considered essential for adequate~     endometrial hormonal modulation in cryopreserved-thawed embryo transfer cycles. Several~     studies, however, have questioned its necessity for controlled endometrial preparation. Using~     a high dose of estradiol from day 1 of the cycle will suppress the gonadotroph, preventing~     folliculogenesis and excessive secretion of LH, allowing adequate endometrial preparation~     without GnRH-a.~   "
63480|NCT02736019|"~     Two hundreds and twenty five postmenopausal women undergoing outpatient hysteroscopy and~     endometrial biopsy will be randomly divided into three equal groups. To ensure blinding the~     investigators will use the double dummy technique in which group 1 will receive Tramadol~     100mg (Trama®, Global Napi, Giza, Egypt) orally in addition to a placebo similar to~     Celecoxib, group 2 will receive Celecoxib 200mg (Celebrex® 200, Pfizer, USA) in addition to a~     placebo similar to Tramadol, and group 3 will received a placebo similar to Tramadol and a~     placebo similar to Celecoxib. All drugs will be given 2 hours before the procedure. An~     independent person will generate the allocation sequence using computer generated random~     numbers.~      Patient's perception of pain will be assessed for each group during the procedure,~     immediately after and 30 min after the procedure with the use of visual analogue scale (VAS).~   "
63481|NCT02736006|"~     Diving disorders and particularly Decompression sickness (DCS) represent a major concern in~     recreational and occupational pressure-related activities. As a result of decompression from~     higher to lower ambient pressure bubbles which are formed in vascular flow and in tissues~     take part in embolism then resulting in DCS. Individual factors such as vascular or~     respiratory defects are now considered to increase the risk of this dysbarism disease.~   "
63482|NCT02735993|"~     This cardiac registry study will collect information from patients with ischemic or~     non-ischemic heart failure that have been treated with adipose-derived regenerative cells~     (ADRCs) delivered via intramyocardial injection.~   "
63483|NCT02735980|"~     The purpose of this study is to evaluate the safety and efficacy of prexasertib when given to~     participants with extensive stage disease small cell lung cancer (ED-SCLC). The study will~     evaluate how the body processes the drug and how the drug affects the body. The study will~     also evaluate the association between tumor response and the participant's perceived quality~     of life.~   "
63484|NCT02735967|"~     The aim of this study will be to evaluate the effects of the use of manual therapy and~     diadynamic in muscle trigger points in the upper trapezius muscle in individuals diagnosed~     with shoulder impingement syndrome, unilateral shoulder as functional capacity, pain~     intensity and pain threshold the pressure.~   "
63485|NCT02735954|"~     To learn more about the positive and negative long term medical effects of marijuana use.~     Information obtained during this study may identify new markers that influence the~     development of lung diseases such as COPD. The Investigators are also interested in learning~     more about the effects of marijuana use for insomnia and how it may or may not affect sleep.~   "
63487|NCT02735928|"~     Patients with first recurrent resistance ovarian cancer and disease progression with~     peritoneal carcinomatosis will undergo PIPAC procedure. The primary end point is to determine~     the clinical benefit rate (CBR) of a pressurized intraperitoneal aerosol chemotherapy with a~     combination of cisplatin and doxorubicin.~   "
63488|NCT02735915|"~     The purpose of this study is to evaluate the persistence of immune response to the HZ vaccine~     as well as safety up to 10 years after the first dose of initial vaccination course. This~     study will also assess immune responses after re-vaccination with 2 additional doses of the~     HZ/su administered at ten years after first dose of initial vaccination course from study~     Zoster-003 (NCT00434577).~   "
63489|NCT02735902|"~     The main objective of this study is to demonstrate that a single anticoagulant therapy is~     superior to a combination of anticoagulant and antiplatelet therapy on the net clinical~     benefit estimated at 12 months after a Transcatheter Aortic Valve Intervention (TAVI)~     according to BARC2 criteria (bleeding complications; Mehran et al 2011) and VARC2 (other~     complications; Kappetein et al 2012)..~   "
63490|NCT02735889|"~     The objective of this study is to compare the effect of different levels of carbonation~     isocaloric beverages on glycemic response (using protocol based on standardized glycemic~     index testing methodology), gastric emptying and satiety. It is hypothesized that carbon~     dioxide will delay gastric emptying, and in turn, attenuate glycemic response and enhance~     satiety. The use of a non-nutrient (gas) in improving glycemic response and satiety would~     have important health implications for the beverage industry.~   "
63491|NCT02735876|"~     This study is evaluating the efficacy of acalabrutinib in combination with rituximab (Arm 1)~     versus ibrutinib (Arm 2) versus acalabrutinib (Arm 3) for the treatment of relapsed or~     refractory (R/R) mantle cell lymphoma (MCL).~   "
63492|NCT02735863|"~     This study is a placebo-controlled study aimed at assessing the safety of ABX464 administered~     at 50 mg and 150 mg o.d. versus placebo in HIV infected patients who are treated with~     darunavir + ritonavir (DRV/RTV) or darunavir + cobicistat (DRV/COBI).~   "
63493|NCT02735850|"~     This will be a phase II trial testing if the combination of SBRT and L19-IL2 improves the~     progression free survival in patients with limited metastatic non-small cell lung cancer~     (NSCLC). Treatment will be divided in two cohorts: patients eligible for ablative~     stereotactic body radiotherapy to all metastatic sites (treatment with curative intent) and~     patients not eligible for stereotactic body radiotherapy to all sites (life prolongation).~   "
63494|NCT02735837|"~     Aim:~      The purpose of this study is to investigate the effect of nonsurgical periodontal therapy~     plus subgingivally doxycycline gel 3% on glycemic control in type 2 diabetes mellitus (type 2~     DM) patients who have periodontitis.~      Materials and methods:~      A total of 24 type 2 DM patients with periodontitis will be selected for the study, and~     randomly divided into two equal groups,who are at least 35 years of age and 16 teeth and type~     II diabetes are (at least the last 3 months of diagnosis of diabetes and its FBS More than~     110 have), and also with periodontal disease are chronic moderate (at least in three areas~     Attachment level to a depth of 3-4 mm maxillary or mandibular been confirmed by clinical~     examination and radiographic signs are being); Takes place. The initial HbA1c Patients should~     be between 7-9 percent over the past three months has changed his medication also found the~     necessary explanations on how to do that consent, Plaque index (PI) by Loe & Silness,~     bleeding on probing (BOP) based on Carter and Barnes (if any bleeding number 1 and its~     absence is 0), probing depth (PD) and clinical attachment levels (CAL) were recorded. Group~     1: (12 patients) was treated with oral hygiene instruction, scaling and root planing, and~     doxycycline gel for 15 days; and Group 2: (12 patients) has the same treatment but with~     placebo gel, After 12 weeks their periodontal condition and Fasting blood sugar (FBS),~     glycated hemoglobin (HbA1c) level, will be reevaluated.~   "
63495|NCT02735824|"~     Individuals with suspected primary immunodeficiency will be studied and the results compared~     with healthy controls. Primary immunodeficiency may manifest as recurrent, severe or unusual~     infections as well as signs and symptoms of immune dysregulation such as autoimmunity or~     lymphoproliferation.~   "
63496|NCT02735811|"~     Multicentric, observational, retrospective registry including patients underwent ICD~     implantation for any indication. The primary aim of the registry is to evaluate the long-term~     outcome of patients receiving an ICD.~   "
63497|NCT02735798|"~     This is a single arm pilot study of 64Cu-MM-302 and unlabeled MM-302 in combination with~     trastuzumab in 10 patients with advanced HER2+ cancer with new or progressive brain~     metastases. Patients will receive standard imaging at baseline, including FDG-PET/CT plus MR~     brain imaging. Patients will subsequently start protocol therapy with MM-302 and trastuzumab~     given on day 1 of an every 21-day dosing cycle, at the recommended phase 2 dose of 30 mg/m2.~     Patients will receive 64Cu-labeled MM-302 (3-5 mg/m2 doxorubicin) three hours after unlabeled~     dose of MM-302. Integrated MR/PET imaging of the brain and whole body will be performed at~     two time points following 64Cu-labeled MM-302 administration: (1) within 3 hours (+/- 1 hour)~     of labeled drug injection, and (2) 24 hours (+/- 6 hours) post-injection. Patients will~     continue to receive subsequent doses of unlabeled MM-302 plus trastuzumab every 3 weeks until~     clinical or radiographic disease progression (either in the brain or systemically) or~     unacceptable toxicity, whichever occurs soonest. MR brain imaging and FDG-PET/CT scans will~     be performed every 9 weeks to monitor for treatment response and disease progression.~   "
63498|NCT02735785|"~     The Harnessing Online Peer Education (HOPE) intervention combines social media with a~     psychology-based interventions to change behavior. This intervention is being applied to~     reduce prescription drug abuse among patients with chronic pain.~   "
63499|NCT02735772|"~     A new technique for Applying sutures to the white line in paravaginal repair.~   "
63500|NCT02735759|"~     The purpose of this study is to further evaluate and adjust the photoacoustic flow cytometry~     device and its use in detecting circulating emboli.~      Study Design: Cohort 1: Normal healthy volunteers will be enrolled to further adjust the~     device settings. Cohort 2: Use the Phatoacoustic flow cytometry (PAFC) to detect circulating~     emboli in vivo in patients with venous thromboembolism at diagnosis, during and after~     anticoagulation therapy.~   "
64441|NCT02723487|"~     The primary objective of this study is to assess differences in postoperative pain~     experienced by pediatric patients having transversus abdominis plane block block with~     bupivacaine (0.125% and 0.25%) compared with control group will receive conventional iv~     analgesia after Laparoscopic surgery.~   "
63501|NCT02735746|"~     The purpose of this study is to to compare lung function data generated by applying High~     Fidelity Functional Lung Imaging (HFFLI) software to 4D CT, cone beam CT, and fluoroscopic~     images of the lungs breathing to determine whether different modalities of imaging provide~     similar data on lung movement and function. HFFLI may detect changes in lung function in~     patients undergoing External Beam Radiotherapy for cancer.~   "
63502|NCT02735733|"~     To determine if a balloon tamponade catheter filled with cold saline is more effective than a~     catheter filled with room temperature saline in controlling post partum hemorrhage.~   "
63503|NCT02735720|"~     The use of TEVAR is increasing rapidly and patients even in younger patients. However,~     current endografts are several orders of magnitude stiffer than the native aorta.~     Pre-clinical and clinical studies have reported acute aortic stiffening after TEVAR resulting~     in hypertension, elevated pulse pressure, cardiac remodeling, reduced coronary perfusion, and~     finally, heart failure. These effects are markedly profound in young patients, as their~     hearts and aortas are more compliant. Previous studies on adverse cardiovascular remodeling~     have important limitations, such as retrospective design, use of echocardiography (with low~     reproducibility and high operator-dependency), and mixed populations. A systematic assessment~     of the deleterious effects of TEVAR is still missing.~      The objective of this study is to perform a prospective, non-randomized controlled, study in~     which blood pressure, heart rate, ECG, echocardiography, CT, MRI, intra-luminal hemodynamic~     assessment, computational modeling and biomarkers are used to assess cardiovascular~     remodeling following TEVAR. This study targets patients with thoracic aortic aneurysms (TAA)~     or penetrating aortic ulcers (PAU) treated with TEVAR. A control group will consist of TAA~     and PAU subjects who do not require endovascular treatment.~      The specific aims of the study include: 1) Quantification of cardiovascular remodeling~     following TEVAR in TAA or PAU patients. 2) Validation of computational modeling of thoracic~     aortic hemodynamics following TEVAR using the above clinical measurements. Once validated,~     computational analyses will be performed to virtually assess the impact of more compliant~     endografts on cardiac and aortic hemodynamics. 3) Investigation of diagnostic accuracy of~     ECG, BNP, NT-pro-BNP and Troponin T, for cardiac remodeling compared to MRI, the reference~     method.~      This study will assess the impact of thoracic aortic stent grafts on the cardiovascular~     system through non-invasive measurements. Although there are no direct benefits for the~     enrolled subjects, future aortic patients might benefit from better patient management with~     improved aortic endograft designs and long-term outcomes.~   "
63504|NCT02735707|"~     Randomized, Embedded, Multifactorial Adaptive Platform trial for Community-Acquired Pneumonia~   "
63505|NCT02735694|"~     This study is being conducted to determine whether cycloserine is effective for the treatment~     of sleep apnea. Cycloserine is an antibiotic that has been extensively used in the treatment~     tuberculosis. However, more recently it was shown to enhance memory responses. Cycloserine~     may enhance the response of respiratory muscles to apnea and potentially reduce the severity~     of sleep disordered breathing.~   "
63506|NCT02735681|"~     Meibomian glands (MG) are modified sebaceous glands associated with the tarsus (collagenous~     structural component) of the upper and lower eyelids. Meibomian glands produce lipid-based~     secretions which are an integral and stabilizing part of the tear film. In blepharitis and~     ocular rosacea (two known causes of obstructive meibomian gland dysfunction (o-MGD),~     inflammation of the lid margins causes blockage of the meibomian gland orifices, changes in~     glandular secretions, and dropout of the glands themselves. This limits the production,~     secretion, and quality of meibum. With less oil in the tear film, the aqueous portion of~     tears is not stable and evaporates quickly which leads to dry eye.~   "
63507|NCT02735668|"~     The main objective of the study is to determine whether the invasive physical therapy and~     motor control exercises of shoulder joint together are more effective than motor control~     exercises of shoulder joint and/or shoulder conventional exercises.~   "
63508|NCT02735655|"~     This is a 10 minutes web based survey aims at exploring the current, global state of~     digestive endoscopy training among physicians to identify what are the unmet needs and how to~     improve it.~   "
63509|NCT02735642|"~     Knowledge of HIV status is a first step towards accessing HIV care, treatment, and prevention~     services.The GIRLS study will rigorously compare two 'seek' recruitment strategies, three~     'test' strategies, and two enhancements to an adaptive (SMART trial design) 'linkage' to care~     intervention, among young at-risk women, 15-24 years old, in Homa Bay County, western Kenya.~     Additionally, we will evaluate a scalable primary prevention messaging intervention to~     support identified HIV-negative young women in reducing HIV risk and adhering to recommended~     HIV re-testing recommendations. We will also conduct an economic evaluation, using cost~     effectiveness analyses to determine the relative utility of each seek, test, link, and~     prevention interventions.~      Lessons learned will inform Government of Kenya, and other key policymakers, implementing~     partners and agencies throughout sub-Saharan Africa that are exploring policies about~     appropriate scale up of these multiple seek, test, link, retain, and prevention strategies to~     realize the dream of an AIDS-free future for adolescent girls and young women.~   "
63510|NCT02735629|"~     The study is an investigation to assess the capacity of ascending doses of CX1739 to~     antagonize the respiratory depressive effect of remifentanil. The study will also investigate~     whether ascending doses of CX1739 reduce the analgesic effect of remifentanil or alter the~     BIS measure of sedation and will evaluate the safety of CX1739 when used in conjunction with~     remifentanil.~   "
63511|NCT02735616|"~     By Investigating the heart rate variability (HRV) of 15 patients after stroke and compare it~     to the HRV of 15 orthopedic patients, the investigators hope to achieve 3 main goals:~      1. To describe the 24-hour circadian rhythm of heart rate among patients after stroke in the~     sub-acute phase during 3 days. 2. To examine the differences in the circadian rhythm of heart~     rate along 3 days between patients after stroke in the sub-acute phase and control group~     matched by age and gender. 3. To describe the reaction and examine the differences in~     reactions of the heart autonomic system during rest, paced breathing and activity in both~     groups- stoke and control.~      The HRV will be monitored by Polar watch and the activity will be measured by accelerometer,~     both will be attached to the patients at the beginning of the trial and will stay on them for~     3 whole days.~   "
63512|NCT02735603|"~     The purpose of this study is to evaluate the potential effect of naltrexone and bupropion~     extended-release combination on cardiac repolarization in healthy participants.~   "
63589|NCT02734602|"~     This study is designed to examine SV2A density in MDD and PTSD as a correlate of synaptic~     density, and to determine whether ketamine administration will reverse the synaptic loss in~     vivo in human subjects. To our knowledge, this is the first human study to examine SV2A in~     vivo in MDD and PTSD and to use the first known drug (ketamine) that rapidly reverses~     synaptic loss to determine whether ketamine administration could restore some of the~     structural changes associated with depression and PTSD.~      After a screening process to determine eligibility, all subjects will participate in an MRI,~     and 2-3 PET scans with the administration of ketamine for one of the scans. Cognitive testing~     and a stress test may also be done on scan days.~   "
63513|NCT02735590|"~     Effective tuberculosis (TB) control requires that people who progress from latent~     Mycobacterium tuberculosis (MTB) infection (LTBI) to TB disease are identified and treated~     before they infect others. A prognostic correlate of risk (COR), based on messenger~     ribonucleic acid (mRNA) expression signatures, which prospectively discriminates between TB~     cases and healthy controls, has been constructed and validated. Based on published microarray~     case-control datasets, the COR has 87% diagnostic sensitivity and 97% specificity for~     prevalent TB disease; and in two nested case-control studies, 70% prognostic sensitivity and~     84% specificity for incident TB disease occurring within one year of sampling (HIV uninfected~     persons). Diagnostic and prognostic performance of the COR has not yet been tested in a~     prospective cohort.~      COR+ status is not directly associated with LTBI; and may, or may not, be amenable to~     preventive therapy. Although effective in the short-term, preventive therapy is not~     recommended for treatment of LTBI in HIV uninfected adults living in high TB burden~     countries, due to rapid loss of protection; and treatment burden. A 3-month, 12-dose,~     once-weekly preventive therapy regimen of high dose Isoniazid (INH) and Rifapentine (3HP) has~     been recommended as equivalent to 6 months of daily INH for treatment of LTBI in low TB~     burden countries by the World Health Organization (WHO).~      A 'screen & treat' strategy, based on serial mass campaigns to provide targeted, short-course~     preventive therapy only to COR+ persons at highest risk of TB disease, may offer the solution~     for durable, community-wide protection in high TB burden countries. The efficacy of 3HP for~     prevention of incident TB disease in COR+ persons has not yet been tested in a clinical~     trial.~      Primary Aims~        1. Test whether preventive therapy (3HP) reduces the rate of incident TB disease, compared~          to standard of care (active surveillance), in COR+ persons.~        2. Test whether COR status differentiates persons with cumulative prevalent or incident TB~          disease from persons without TB disease.~      Secondary Aims~        1. Estimate whether COR status differentiates persons at high risk for incident TB disease~          from persons at low risk for incident TB disease~        2. Compare prognostic performance of the COR for incident TB disease with Interferon-gamma~          release assay (IGRA).~   "
63514|NCT02735577|"~     This study combines functional MRI with medication treatment in order to understand the~     neural mechanisms by which disulfiram, a currently approved medication for alcohol use~     disorder, changes behavior. Disulfiram is a medication that prevents drinking by causing a~     highly unpleasant physical reaction when alcohol is consumed while it is being taken. Thus,~     it provides a means for studying the general neural mechanisms by which awareness of risks~     impacts behavior change in alcohol use disorder.~   "
63515|NCT02735564|"~     Bariatric surgery is considered an effective long-term intervention for the treatment of~     obesity and associated complications. While bariatric surgery has been shown to result in a~     large sustained weight loss, the degree of weight loss and maintenance thereafter varies~     greatly. The Heads Up Surgical Demonstration Project (Heads Up) is a 5 year project examining~     weight loss after an intensive medical intervention (IMI) and the 2 most widely used~     bariatric surgeries (roux-en-y gastric bypass or RYGB and sleeve gastrectomy or SG). Baseline~     data are collected prior to surgery and follow-up data are collected at 6 months and annually~     thereafter. A recent meta-analysis revealed that RYGB resulted in greater weight loss and is~     more effective in resolving obesity related comorbidities than SG, although SG has been shown~     to result in a reduction of perioperative complications and reoperations1. Full elucidation~     of the mechanisms leading to variation in success for weight loss interventions is crucial to~     understanding the most effective and reliable treatments for obesity and associated~     comorbidities.~   "
63516|NCT02735551|"~     This prospective randomized controlled study will evaluate if Long Acting Reversible~     Contraceptive (LARC) forward counseling in combination with same-day LARC placement increases~     overall LARC uptake within a community college population compared to LARC forward counseling~     and referral to a secondary clinic for LARC placement. The study will be conducted at Mount~     Hood Community College (MHCC) in Oregon. Participants will be enrolled into three groups. All~     groups will receive the same standardized contraceptive counseling (LARC forward~     counseling) and participants will be able to choose between a LARC method and short-acting~     method of birth control.~   "
63517|NCT02735538|"~     The trial detected mRNA expression of several bone repair-related genes, including Runx2, in~     the femoral head and neck of patients with osteonecrosis of femoral head (ONFH) . Runx2~     expression was compared with that of identical tissue from osteoarthritis patients to~     identify expression in necrotic femoral head tissue, which will help clarify the role and~     possible clinical significance of Runx2 in femoral head necrosis, bone repair and~     reconstruction.~   "
63518|NCT02735525|"~     The proposed trial is a pilot to test a smartphone application (app) that will ultimately~     allow patients to take and transmit photos of their postoperative wounds from home and relay~     other symptom information. This protocol covers the single-institution pilot study of the~     app's use in the period between hospital discharge and a patient's first follow-up clinic~     visit. The investigators will recruit vascular surgery patients either preoperatively in~     clinic or in the post-operative, pre-discharge period following surgery to participate in the~     pilot. Using a training protocol refined in the usability-testing phase of the project,~     patients will be trained to use the smartphone and the wound surveillance app prior to~     discharge. Patients will use the app from home to take send digital images of their~     postoperative wounds and answer a short survey, all of which will be transmitted to a secure~     database maintained by the University of Wisconsin (UW) Department of Surgery and accessible~     only to UW-employed study personnel. These data will be evaluated by one of three vascular~     surgery service nurse practitioners (NPs) daily and entered into the medical record. Patients~     who have concerning findings either in their images or in their survey answers will be~     contacted for further evaluation. Smartphones will be provided to patients who do not have~     one of their own, through a partnership with AT&T. Sociodemographic and comorbidity data~     collected from the medical record will be kept at UW Department of Surgery on a secure server~     and accessible only to UW employed study personnel.~   "
63519|NCT02735512|"~     This pilot research trial studies how well myeloid derived suppressor cells (MDSC) clinical~     assay works in finding and monitoring cancer cells in blood and urine samples from patients~     with or without localized or metastatic bladder cancer. Studying samples of blood and urine~     from patients with or without bladder cancer in the laboratory may help doctors identify and~     learn more about biomarkers related to cancer and may help doctors improve ways to diagnose~     and treat patients.~   "
63520|NCT02735499|"~     Instillation treatment with onabotulinumtoxin A (BOTOX®) in the urinary bladder~   "
63521|NCT02735486|"~     The primary aim of the study was to investigate the acute effect of ginger drink consumption~     on the risk markers of cardiovascular disease.~   "
63522|NCT02735473|"~     This is a randomized, double-blind, placebo-controlled trial of choline supplementation in~     children with Fetal Alcohol Spectrum Disorders (FASD). The primary outcome measures are~     cognitive measures.~   "
64180|NCT02726906|"~     The purpose of this study is to examine the effects of modifiable lifestyle factors including~     exercise and healthy living on brain health. The investigators will compare 2 types of~     interventions, moderate aerobic walking vs. healthy living education, over 6 months to~     evaluate changes in brain health, cognition, and physical function in older adults with~     cognitive concerns.~   "
63523|NCT02735460|"~     Andago V2.0 is a recently developed overground gait and balance training device. Many~     patients in neurorehabilitation suffer from gait disorders, most typically after stroke.~     Since pharmacological therapies are basically not available, neurorehabilitation plays an~     important role in the treatment of such patients. The Andago V2.0 may represent a useful~     device in the rehabilitation of stroke and other neurological patients featuring a severe~     gait disorder. Therefore a study has been designed to investigate the usability of the Andago~     V2.0 in the setting of a neurorehabilitation clinic. The primary outcomes of this study are~     the usability and acceptance of the investigational medical device (IMD). Usability is mainly~     measured by the time spent for the set-up and release of the participant, achieved training~     times and distances, the number of stumbles, collisions and emergency stops and the error~     messages during the session. Besides patient and therapist satisfaction with the Andago V2.0~     is recorded.~   "
63524|NCT02735447|"~     Sporadic inclusion body myositis (sIBM) is a rare idiopathic inflammatory myopathy~     characterized by chronic proximal leg and distal arm asymmetric muscle weakness. Its~     prevalence is estimated between 10 and 100 cases per million, over the age of 50. Little is~     known about the natural course of the disease, the delay between onset and diagnosis, the~     patterns of disease management and treatment in routine practice, as well as the burden for~     patients.~      The objectives of the PGRx-sIBM study will be to describe:~        -  The epidemiology of the disease (estimation of the prevalence, age at onset, delay~          between onset and diagnosis, diagnosis process, etc.)~        -  The patterns of disease management and treatment in routine practice~        -  The burden of the disease for patients and their informal caregiver, as well as the~          quality of life of patients~        -  The burden of the disease for informal caregivers~      This will be an observational (non-interventional), cross-sectional (transversal) study.~      Study setting The PGRx-sIBM will take place in France, Italy, Switzerland and Spain.~     Recruitment centers will be public and private practices and hospitals from urban or rural~     areas. In each recruitment center, at least one physician will act as a study investigator,~     in charge of identifying and recruiting patients.~      Inclusion of patients~      Patients will be included by their specialized physician (neurologist, Internal Medicine)~     during a regular outpatient visit, provided that they meet the following inclusion criteria:~        -  The patient has been diagnosed with sIBM, as per the physician judgement and regardless~          of the date of diagnosis~        -  Male or female~        -  Age ≥ 45 years old~        -  The patient does regularly live in the country of inclusion~        -  The patient or his/her proxy can read and respond to a telephone interview~        -  The patient agrees to participate~      Exclusion criteria will be:~        -  The patient refuses to participate or the written Consent Form is not signed~        -  The patient or his/her proxy cannot be reached by telephone. All eligible patients will~          be invited to participate in the study, during a 3 to 6-month period of time.~      The target sample size will be of 190 patients (≈15-20 in Switzerland, ≈50 in Spain, ≈50 in~     Italy and ≈70-75 in France).~   "
63525|NCT02735434|"~     Health anxiety is a prevalent, disabling disorder associated with extensive health care~     expenditures. The lack of easily accessible, evidence-based psychological treatment combined~     with delayed diagnostic recognition constitute barriers to receiving treatment.~      Aim~        1. To develop an internet-delivered treatment program, based on 'Acceptance and Commitment~          Therapy' (ACT), for patients with health anxiety.~        2. To test the feasibility and effectiveness of the treatment programme in a randomized,~          controlled trial, comparing the treatment with an active control condition.~      Methods 150 patients aged 18 years and older can self-refer through a web-page to apply for~     participation. Before inclusion patients will undergo a video-diagnostic interview. Patients~     are randomly assigned to 12 weeks of either, 1) active treatment: consisting of~     internet-based ACT (iACT) with 7 therapist-guided modules of self-help text, exercises,~     patient videos and audio-files, or 2) active control condition: consisting of an~     internet-based discussion forum (iFORUM) with 7 topics of discussion.~      All patients will complete self-report questionnaires at baseline, before randomization, at 4~     and 8 weeks into treatment, after end of treatment, and at 6-month follow-up.~   "
63526|NCT02735421|"~     This is a multi-centre, randomized, investigator blinded, vehicle controlled trial using~     intra-individual comparison (right half-face versus left half-face).~      Subjects will have each half-face randomized to one of the two following treatments:~        -  Adapalene 0.3% - BPO 2.5% gel (TactuPump® Forte).~        -  Vehicle gel~      The main objective of this trial is to evaluate the effect of Adapalene 0.3% - benzoyl~     peroxide (BPO) 2.5% gel versus vehicle gel on the risk of formation of atrophic acne scars in~     moderate to severe acne subjects.~   "
63527|NCT02735408|"~     Lumbar pain is a quite prevalent pathology in general population within general and sporting~     population, which comes to mean high sanitary and sport costs. This concrete pain´s nature is~     often unspecific, but it seems that one of the main risk factors that predispose to suffer~     from it are changes in the paravertebral-lumbar musculature stiffness.~      Since one decade approximately, it has proliferated, especially within sportsmen and women~     the use of a therapeutic technique: the neuromuscular bandage best known as Kinesiotape (KT).~     This treatment seems to accept different applications, despite there´s still a lack of~     scientific evidence for several of its supposed effects. One of the theories about its use~     technique is that the bandage strain generates different effects in musculature stiffness.~     Thus, when the bandage is applied over the skin with a pre-stretching of the elastic bandage,~     it can cause arise of stiffness and strength muscle empowerment. On the other hand, if the~     bandage is applied without strain, the opposite result would appear, relaxation and strength~     muscle decrease.~      For trainers and therapists is important to know if the KT effect differs over the bandage~     technique, since the application could be different according to the specific troubles~     reported by the athletes. For example, talking about cyclists, who keep constantly a hold~     rachis lumbar flexion, could be interesting to normalize the lumbar musculature stiffness, by~     placing the bandage with certain strain to achieve a mechanic effect. Nevertheless, talking~     about other sports like weightlifting, the bandage effect should be the stiffness arisen as a~     preventive measure, for avoiding injuries derived from the lack of motor control in the~     lumbar region. These lumbar-region muscle problems affect to popular and majority sports like~     football, so lumbar pain is very frequently reported by football players, normally due to an~     agonist-antagonist musculature unbalance. In all these terms, the use of KT would be~     interesting in order to reduce the musculature strain degree.~      Tensiomyography (TMG) is showing as one of the most useful and reliable instrument for the~     musculature stiffness assessing, due to its velocity, harmlessness, sensing and high~     reproducibility. Taking in consideration that the maximum deformity measured by the TMG is~     inversely related with the muscle stiffness, and whereas this project pretends to modify that~     stiffness by means of the KT application, it seems obvious that TMG is the most suitable~     measurement instrument.~      All these precedents considered, the present project pretends to analyze the effects of~     different KT strain application along 48 hours with strains techniques of 100%, strain 50%~     and strain 0% in the normalization of the paravertebral-lumbar musculature stiffness, by~     means of TMG monitoring.~   "
63528|NCT02735395|"~     The aim of this study was to compare the clinical and microbiological outcomes of different~     dosages of metronidazole (MTZ) and of the duration of the systemic administration of MTZ and~     amoxicillin as adjunct to scaling and root planing (SRP) in the treatment of generalized~     chronic periodontitis (GChP).~   "
63529|NCT02735382|"~     This study is designed to assess whether completely electronic, HIPAA-compliant, EHR-based,~     closed-loop referrals for tobacco cessation from primary care clinics to a state telephone~     tobacco quitline service can increase the number/percentage of adult tobacco users receiving~     evidence-based tobacco dependence treatment when compared to paper-based fax referrals.~   "
63643|NCT02733900|"~     In this study, the aim is to identify the modifications responsible for aseptic osteonecrosis~     of the femoral head and its structural evolution by the association of the micro scanner~     analysis and Raman spectrometry performed on the femoral heads removed during hip~     replacements. The study of femoral heads will allow the analysis of bone tissue at two~     different scales, both correlated with the biomechanical properties of the bone. Also, the~     association with preliminary MRI analysis will provide pathogenic explanations correlated to~     these modifications.~   "
63530|NCT02735369|"~     The present study is intended to evaluate the efficacy and safety of topical OC-10X~     Ophthalmic Suspension in patients diagnosed with proliferative diabetic retinopathy (level~     61, 65, 71, or 75). OcuCure Therapeutics, Inc. (Roanoke, VA) has developed a lead compound,~     known as OC-10X, which is a selective tubulin inhibitor under development for the treatment~     of Proliferative Diabetic Retinopathy (PDR) and Age-related Macular Degeneration (AMD). When~     administered as a topical eye drop, OC-10X has both anti-angiogenic (inhibition) and~     angiolytic (regression) properties in animal models of choroidal neovascularization (CNV).~     Unlike other therapies, OC-10X provides the efficacy of a vascular targeting agent without~     the traditional toxicity and works downstream independently of growth factors. As~     demonstrated by OcuCure's preclinical data, tubulin inhibition, using OC-10X, may be a~     promising new approach to the treatment of PDR and AMD. Like AMD, PDR is a major cause of~     blindness in adults and is also caused by the growth of abnormal blood vessels. Importantly,~     the Phase I Study found that OC-10X can be safely applied topically in human eyes without~     adverse ocular or systemic effects.~      Currently, there are few options for the treatment of PDR. Clinical options, such as laser~     photocoagulation or vitrectomy, require surgery and can permanently impair patients' vision.~     With few treatment options available, administration of OC-10X as a topical therapy, along~     with its novel mechanism, has the potential to provide benefits to patients with ocular~     diseases associated with angiogenesis.~   "
63531|NCT02735356|"~     This phase 0 trial studies how well itraconazole gel works in treating patients with basal~     cell cancer. Itraconazole gel may help to treat basal cell tumors in patients.~   "
63532|NCT02735343|"~     Investigators are comparing Ketamine to prochlorperazinecompazine for benign headaches in the~     ED. Subjects will be randomized into 1 of 2 groups. Group 1 will receive standard treatment~     of prochlorperazinecompazine 10 mg IV along with diphenhydramine 25 mg IV. Group 2 (research~     arm) will receive Ketamine 0.3 mg/kg along with ondansetron 4 mg IV. Subjects will be seen at~     15, 30, 45, and 60 minutes post-intervention to obtain Heart Rate, Blood Pressure, Headache~     severity, Nausea severity, Vomiting severity, Anxiety severity, and Restlessness severity. At~     24-48 hours post intervention we will contact subjects and assess their pain and assess their~     satisfaction with their migraine pain management as part of this study. Subjects'~     participation will last up to 48 hours post headache.~   "
63533|NCT02735330|"~     To study the effect of Intra operative Coeliac plexus alcohol neurolysis combined with Frey's~     procedure for effective pain relief in patients with Chronic Calcific Pancreatitis in a~     single centre setting with a Randomized Controlled Trial.~   "
63534|NCT02735317|"~     Radiation therapy remains the principal treatment for nasopharyngeal carcinoma (NPC). The~     most frequently occurred radiation-related side effect is probably the radiation-induced oral~     mucositis (OM), which affects up to 100% of NPC patients receiving radiation therapy. When~     severe, oral mucositis increases the risk of infection and may compromise clinical outcomes~     by necessitating treatment breaks, dosage reductions, and reduced therapy compliance. In~     China, a quadruple mixture, composed of dexamethasone, gentamicin, vitamin B12, and procaine,~     is commonly prescribed when NPC patients begin to suffer from radiation-induced OM. However,~     the incidence of radiation-induced OM is still quite high. Oral Ulcer Gargle (FORRAD®) is a~     proprietary viscous liquid mucoadhesive hydrogel formulation. It creates a palliative barrier~     over injured mucosa, to prevent and to cure radiation-induced OM. The objective of this~     randomized phase II study is to assess the efficacy and safety of Oral Ulcer Gargle (FORRAD®)~     as an intervention for radiation-induced OM in the treatment of NPC, compared with the~     commonly used quadruple mixture, which is composed of dexamethasone, gentamicin, vitamin B12,~     and procaine.~   "
63535|NCT02735304|"~     This clinical study seeks to address four independent questions that are all part of the~     delivery of care associated with the provision of a single item of treatment; an indirect~     restoration (known as a 'crown') to restore and cover a damaged tooth. The provision of a~     crown requires a series of sequential clinical and laboratory stages stages:~        1. Stage 1 - Preliminary impression. Taking a pre-operative impression of the tooth to be~          crowned. This will be used to enable the fabrication of the temporary crown after the~          tooth has been prepared. This is standard care and follows established clinical~          protocols.~        2. Stage 2 - Preparation of the tooth. This involves cutting the tooth back to make space~          for the crown that will be fabricated to replace the missing structure.~        3. Stage 3 - Taking an impression of the prepared tooth. From this a duplicate model will~          be made to fabricate the crown. To take the impression, the dentist will need to gently~          push the gums away from the tooth by fractions of a millimeter so that the margins of~          the preparation are clearly discernible.~        4. Stage 4 - Provision of a temporary restoration that will provide satisfactory function~          for a limited period of time, until the definitive crown can be fitted. This temporary~          crown is designed to have a finite short-term durability and have an ease of manufacture~          and subsequent removal; hence the use of a specific cement that will enable this.~        5. Stage 5 - Fitting of the definitive restoration. This is designed to be a durable~          restoration, with a mean life expectancy measured in years, but which is ultimately~          determined by a number of clinical, biological and patient specific parameters.~          Definitive restorations are fitted with cement designed to retain the crown in permanent~          manner.~   "
63536|NCT02735291|"~     This single-arm,multicenter Phase 2 trial will treat the patients who have recurrent or~     refractory acute non T lymphocyte leukemia with an infusion of the patient's own T cells that~     have been genetically modified to express a chimeric antigen receptor (CAR) that will bind to~     tumour cells that express the EPCAM protein on the cell surface.The study will determine if~     these modified T cells help the body's immune system eliminate tumour cells.The trial will~     also study the safety of treatment with CAR-T,how long CAR-T cells stay in the patient's body~     and the impact of this treatment on survival.~   "
63537|NCT02735278|"~     In optometry, binocular coordination is measured subjectively. The result is subjective~     fixation disparity. In research different experiments have proven, that subjective and~     objective fixation disparity are different. A binocular eyetracker has to be calibrated.~     There are two well known calibration methods: associated and dissociated calibration.~     Objective fixation disparity is measured in arcMin. Therefore, the precision of the~     eyetracker plays a crucial role. Now, the investigators try to compare dissociated~     calibration with polarized filters and associated calibration under different test paradigms.~   "
63654|NCT02733757|"~     Regional anesthesia in orbit can reduce ocular blood flow, increase in intraocular pressure~     (IOP) or the pharmacological action of local anesthetics. This study was conduced to evaluate~     the effects of clonidine added to lidocaine in IOP, ocular perfusion pressure (PPO) and~     ocular pulse amplitude (OPA) in patients undergoing cataract surgery under sub-Tenon's and~     peribulbar anesthesia.~   "
64181|NCT02726893|"~     About 30% of patients were reported to suffer inadequate bowel preparation.~   "
73958|NCT02598817|"~     The purpose of this study is to evaluate the effects of term infant formula containing high~     2-palmitic vegetable oil on stool composition, stool characteristics and gastrointestinal~     (GI) Tolerance.~   "
63538|NCT02735265|"~     Virtual reality balance training has already been used in stroke rehabilitation, and previous~     studies supported that could improve balance ability. Although the treatment effects were~     supported in studies, there are still limitations in clinical intervention and the study~     power is not enough.~      Study will use Kinect for Xbox games for balance intervention. Investigators will recruit 60~     patients with chronic stroke from Shung-ho hospital clinical rehabilitation and randomly~     assign participants to standard treatment plus virtual reality group (N=30) and standard~     treatment only group (N=30). There are total 12 sessions (2 times weekly) for both groups.~     Investigators will assess subjects' ability for 3 times (pre- and post-intervention, follow~     up in post 3 month).Investigators will also record the pleasure scale and adverse event after~     every training session. Hypothesis is that Kinect for Xbox intervention can significantly~     improve subjects' balance ability, confidence of balance, ADL, and QOL compared to the~     conventional rehabilitation. It may help to develop a new clinical model of virtual reality~     training for patients with chronic stroke.~   "
63539|NCT02735252|"~     This is a tissue and blood collection protocol requiring image-guided biopsies of metastatic~     prostate cancer. Whenever possible, a new bone lesion or new/progressing soft tissue lesion~     will be chosen for biopsy as opposed to radiographically stable lesion. Patients will be~     enrolled in parallel into one of five patient cohorts based modality of planned or recently~     initiated systemic therapy, as well as disease setting: (A) Androgen signaling inhibitor, (B)~     Immunotherapy, (C) Chemotherapy, (D) Targeted therapy, or (E) Castration-sensitive disease.~     Patients in cohort E will be enrolled in one of two groups: Group 1 (treatment-naïve), and~     Group 2 (pre-treated) (see previous section for definition). Patients enrolled in Cohorts~     A-D, as well as Cohort E group 1, will undergo baseline tumor biopsy prior to initiation of~     next line of systemic therapy. For patients enrolled in Cohort E, group 2, patients will~     undergo the first tumor biopsy between 6-8 months after first dose of LHRH analogue delivered~     as treatment for metastatic prostate cancer.~   "
63540|NCT02735239|"~     This is an open-label, Phase 1/2 study to evaluate the safety of durvalumab (MEDI4736) in~     combination with oxaliplatin/capecitabine chemotherapy in metastatic/locally advanced~     oesophageal cancer (OC) and with neoadjuvant chemo(radio)therapy before surgery in operable~     OC. The immunotherapy will be given for a 4-week period before starting the standard~     chemo(radio)therapy, continuing durvalumab treatment once the chemotherapy starts. The study~     will include 2 phases, a safety run-in Phase 1 (Cohorts A1 and A2) and an expansion Phase 2~     (Cohorts B, C, and D).~   "
63541|NCT02735226|"~     The Shanghai Stroke Service System（4S） has been established as the network of stroke care in~     greater Shanghai metropolitan area. The system includes 11 territorial-care hospitals and~     their comprehensive stroke unites that provide 24h/7day acute stroke care to a population of~     40 million in Shanghai. The System comprised of two consecutive phases, the acute phase that~     emphasized on providing thrombolysis, and the in-hospital phase that concentrated on the~     effort of recovery and secondary stroke prevention. The novel electronic data aquisition~     system provides the contiguous data of clinical care of stroke patients from the acute phase~     of management to inpatient rehabilitation. This system has been implemented and maintained as~     an ongoing quality of stroke care project that monitored the process of routine stroke care~     in Shanghai. It is funded by the Shanghai Municipal Commission of Health and Family Planning.~     Our analysis of the project was approved by the Ethics Committee, which agreed that no~     written informed consents were needed since the study only was consisted of a~     population-based retrospective data analysis.~   "
63542|NCT02735213|"~     The purpose of this study is to observe whether micropulse laser (MPL) is noninferiority to~     traditional laser therapy in central serous chorioretinopathy.~   "
63543|NCT02735200|"~     After obtaining the approval from the IRB of University of Dammam and informed consent from~     550 healthy patients, with vitamin D deficiency and vitamin D insufficiency and deficiency~     were recruited. Age, weight and height will be taken, a detailed history, meticulous clinical~     examination was performed to rule out any diseases and complete blood picture, serum calcium,~     phosphorous, alkaline phosphatase, Parathormone and 25 Hydroxy-vitamin D (25OHD) will be~     done. 25-Hydroxy Vitamin D3 was measured in house by chemiluminescence immunoassay (CLIA) and~     ≥30ng/mL was taken as normal, 21-29ng/mL as insufficiency and ≤20 ng/mL as deficiency. The~     participants were divided into two groups of 350 in study arm and 200 in control arm. All~     participants were instructed not to change their dietary habits and life style till the study~     was over. The study group of women were instructed to apply to apply Top-D (Proniosomal~     Delivered- Vitamin D3) 1 gram containing 5000 IU of vitamin D3. The second group used 1 gram~     of Aloe vera gel. The participants had no knowledge to which group they belong. A second~     blood sample was taken at the end of 4 months and the data was entered in the data base and~     analyzed using SPSS Inc version 19.~   "
63544|NCT02735187|"~     Patients will be screened up to 28 days before start of treatment. During the screening~     visit, the purpose and procedures of the study will be explained to potential patients and~     informed consent will be obtained.~      At the baseline visit, all inclusion and exclusion criteria will be re-assessed. Eligible~     patients will be randomized to treatment of the target area with either 30 minutes (group30)~     or 15 minutes (group15) blue light at 600 mW/cm². Additionally, two study areas with similar~     clinical symptomatology will be determined and will be randomized to blue light treated area~     and Daivonex treated area.~      After randomization, patients will be trained on a demonstrator device (no actual treatment~     to ensure investigator is blinded as to which group the patient is randomized to) as well as~     the Daivonex cream. After patients have been instructed, treatment of the areas will be~     applied daily (once per day, 5-7 times / week) at home for a treatment period of 12 weeks.~     During those 12 weeks, patients will return to the study site for safety and effectiveness~     assessments at week 2, 4, 8 and week 12. A phone call visit will be performed after one week~     of treatment to check for any adverse events or problems in handling the device or the cream.~     The visit at week 12 serves as end of treatment visit. The patients will be followed-up for~     another 4 weeks. Treatment responses will be photo documented.~   "
63655|NCT02733744|"~     This research study is studying an intervention called fecal microbiota transplantation~     (FMT). Patients who are scheduled to undergo Hematopoietic Stem Cell Transplantation are~     invited to take part in this clinical trial to undergo empiric FMT soon after hematopoietic~     engraftment. The primary endpoint will be to assess the feasibility of FMT in this population~     and to assess safety.~   "
63545|NCT02735174|"~     This is a pilot study to improve the partnership between Cincinnati Children's Medical Center~     (CCHMC), Cincinnati Public Schools (CPS), and Cincinnati Health Department (CHD) to reduce~     childhood asthma in the inner city schools of Cincinnati and CCHMC. We are calling this~     project asthma-free schools and bringing it to neighborhoods where the incidence of asthma~     is especially high. We have designed this study to work with school-based asthma care~     programs. Children with high-risk asthma will be asked to participate. High-risk will be~     defined as poorly controlled asthma, frequent school absences, and/or need for daily~     controller asthma medications. We will use a commercially available inhaler cap sensor to~     help track medication use and symptoms through a smartphone. The study visits will be done~     mostly at the school using telehealth technology similar to Skype.~   "
63546|NCT02735161|"~     The aims of the current study is to explore if different exercise training protocols affect~     fatigue post-exercise, and if sarcoidosis-related fatigue and maximal and sub-maximal~     cardiopulmonary exercise test (CPET) variables change after a 4-weeks exercise training~     period.~   "
63547|NCT02735148|"~     Stroke is one of the most common causes of acquired adult disability. The majority of stroke~     survivors have mobility difficulties such as poor standing, decreased walking speed, balance~     disturbances, and increased risk for falls. Improving mobility, functional walking and~     balance are the main goals of stroke rehabilitation. Robotic technologies are becoming more~     promising intervention for the locomotor training in stroke rehabilitation. Static or dynamic~     balance deficits act crucial role on gait performance among stroke survivors. Therefore it is~     important to determine the effects of BWSTT in improving balance in persons with stroke.~     Although it has been demonstrated that BWSTT improved balance and gait performance in stroke~     patients, it is not clear whether the improvements are greater compared with those associated~     with other gait rehabilitation methods. To the investigators knowledge, there are also~     limited studies in the literature concerning the effects of BWSTT on falling risk in stroke~     patients. The strong evidence is needed about the effectiveness of BWSTT including~     comprehensive determinants of balance with combined and isolated intervention groups.This~     study aims to compare the effects of BWSTT with combined and isolated intervention on~     balance, gait and fall risk in patients with subacute and chronic stroke. The investigators~     hypotheses are that after stroke:~        1. the combination of BWSTT with conventional training may lead to more improved balance~          parameters;~        2. when applied as an isolated intervention, BWSTT or conventional training may lead to~          similar results.~   "
63548|NCT02735135|"~     The main objective of this study is to compare the AIRSOFT DUO and the SENTRY 1200 constant~     pressure mattresses in terms of peak skin pressures measured at the sacral area.~   "
63549|NCT02735122|"~     This is a Dental Pain Study which will evaluate the analgesic onset, efficacy and safety of~     1000 mg acetaminophen as two Test acetaminophen 500 mg tablets, compared with commercial~     products of acetaminophen 1000 mg administered as two 500 mg caplets, and ibuprofen (IBU) 400~     mg following third molar (wisdom tooth) extraction.~   "
63550|NCT02735109|"~     The confocal microscope is a noninvasive imaging technique that provides high-resolution~     images to a depth of 250 microns, such as optical cuts in three dimensions in the thickness~     of the skin.~      This is a single-center prospective descriptive study at the University Hospital of Nice in~     gynecology and dermatology.~      The aim of the study is to describe the characteristics reproducibly for confocal microscope~     of normal vulvar mucosa lesions VIN, and vulvar squamous carcinoma.~      The patients seen in consultation with vulvar lesions suspicious looking will be included.~      The results will be compared systematically to the histological results of biopsies of~     lesions (gold standard).~   "
63551|NCT02735096|"~     The human body uses vestibular feedback in coordination with visual and somatosensory~     information to maintain balance and posture. However, various inner-ear disorders due to~     aging, drug toxicity, viral infections, and injury, etc., may result in loss of vestibular~     feedback, which makes it difficult for an individual to maintain balance. This study~     investigates the use of a hidden and noninvasive balance device EquiCue™ V1 developed by~     Innervo Technology for vestibular substitution. EquiCue™ V1 is a retainer-like intraoral~     electronic balance aid entirely worn inside the oral cavity and provides in-situ sensory~     feedback of head tilting and motion on the roof of the mouth. The feedback is delivered by~     applying small and controlled electrical pulses at precise locations on the palatal surface~     according to an encoded pattern. This pilot study is to determine how this alternative~     sensory feedback on the roof of the mouth can be used to improve balance for patients with~     vestibular loss.~   "
63552|NCT02735083|"~     The purpose of this study is to evaluate the long-term safety and efficacy of UCART 19~     administration to patients with advanced lymphoid malignancies.~   "
63553|NCT02735070|"~     The primary objective of this study is to evaluate the non-inferiority of Coristina® d in the~     symptomatic treatment of the common cold compared to Resfenol® comparator.~   "
63554|NCT02735057|"~     Management of elderly patient with cancer is a therapeutic challenge and a public health~     problem. The mean age of esophageal cancer is 64.5 years and 72.1 years in men and women~     respectively. Surgery is a standard treatment reserved to about 30 % of patients. The other~     70 % are considered unfit for surgery for various reasons, including ageing.~      Chemoradiotherapy (CRT) is standard treatment for patients with esophageal cancer unfit for~     surgery. The validated treatment scheme is external beam radiotherapy (EBRT) 50 Gy over 5~     weeks combined with cisplatin and 5FU infusion. However it induces high rates of severe and~     life threatening toxicities: grade 3 haematologic and esophageal mucositis of 20 and 25 %~     respectively, in patients with a median age of 64 years. CRT has not been properly evaluated~     in patients more than 75 years, and other combined chemotherapy are challenging.~   "
63555|NCT02735044|"~     Primary Objective:~      To compare the efficacy of HOE901-U300 to Lantus in terms of glycated hemoglobin (HbA1c)~      Secondary Objectives:~        -  To compare HOE901-U300 and Lantus in terms of:~        -  Percentage of patients reaching target HbA1c and fasting plasma glucose (FPG).~        -  To assess the safety of HOE901-U300 including analysis of events of hypoglycemia, events~          of hyperglycemia with ketosis, and development of anti-insulin-antibodies.~   "
63676|NCT02733471|"~     This study evaluates the efficacy and safety of the administration of lidocaine spray in~     oesophago-gastro-duodenoscopies. Half of the patients will receive lidocaine spray, while the~     other half will receive a placebo.~   "
63556|NCT02735031|"~     Approximately 25% of patients with type 1 diabetes have lost the capacity to timely detect~     hypoglycaemia, a condition referred to as impaired hypoglycaemic awareness (IHA) that causes~     a six-fold higher risk of severe, potentially hazardous, hypoglycaemia. IHA is usually the~     end-result of a process of habituation to recurrent hypoglycemia that is potentially~     reversible. Treatment with glucagon-like peptide (GLP)-1 Receptor Agonists (1RAs) in addition~     to insulin therapy may decrease the incidence of hypoglycaemia in patients with type 1~     diabetes. This study will test the hypothesis that treatment with the GLP-1RA, exenatide,~     added to basal-bolus insulin therapy will improve awareness of hypoglycaemia in patients with~     type 1 diabetes and IHA. In a randomized doubleblind placebo-controlled cross-over trial,~     patients will be treated for 6 weeks with exenatide (or placebo), after which hypoglycemic~     symptoms and counterregulatory hormone responses will be examined during a hyperinsulinemic~     hypoglycemic glucose clamp study.~   "
63557|NCT02735018|"~     The study aim to evaluate systemic response of patients when 2 different concentrations of~     Epinephrine are injected during inferior alveolar nerve block for wisdom teeth extraction.~   "
63558|NCT02735005|"~     Heterogeneous modalities of aging lead to describe three categories of elderly patients:~     1-healthy without frailty, 2- healthy with frailty, 3- patients with chronic disease(s) and~     frailty. Frail people have a high risk of losing functional independence and as a consequence~     they require more help for day to day life. It is known in elderly that physical activities,~     nutrition, social environment are important to maintain functional independence.~      For patients with disabilities, less is known about the occurence of dependance with aging.~     That is of growing importance because life expectancy of disabled patients has increased a~     lot during last decades, and because caregivers, often parents, also become elderly and~     frail.~      So the investigators will require tools to anticipate prevention and supportive needs for~     this specific population.~      The goal of this study is to evaluate if the participants (disabled patients over 40 years~     old) of a well-defined region in the south-east of France (400000 inhabitants), and to assess~     their needs, using the Functional Autonomy Measurement System (SMAF) developed for assessment~     of the elderly, by Rejean Hebert & Nicole Dubuc's team in Sherbrooke University~     (Quebec/Canada).~   "
63559|NCT02734992|"~     Research to date suggests that individuals with headache use avoidance as a way to manage~     their pain. Despite the wide use of avoidance as a coping mechanism of headache triggers,~     very little empirical evidence exist to support its effectiveness in headache management. New~     treatment approaches, such as Acceptance and Commitment Therapy (ACT), emphasize acceptance~     of headache and valued-living as alternatives to avoidance, have demonstrated preliminary~     support in helping individuals reduce headache-related disability and improve quality of~     life. Though, ACT has received empirical support for various chronic pain conditions, very~     little evidence exists as to its effectiveness for head pain problems. The current study will~     examine the effects of an ACT-based intervention when added to medical treatment as usual~     (MTAU) vs. a wait list control group comprised only of MTAU, on improving quality of life and~     decreasing disability among headache sufferers.~   "
63560|NCT02734979|"~     To investigate whether addition of the Biobridge scaffold to the standard surgery for~     vascularized lymph node transfer will improve the outcome of surgical treatment in lymphedema~     of the upper arm.~   "
63561|NCT02734966|"~     The purpose of this study is to investigate the safety, effective dosage and treatment of~     Magnesium Isolycyrrhizinate Injection to cure the acute drug-induced liver injury compared~     with the Tiopronin Injection.~   "
63562|NCT02734953|"~     Pulmonary hypertension is characterized by an increase in the pressures in the blood supply~     to the lungs greater than a mean pressure of 25mmHg and a concomitant increase in overall~     pulmonary vascular resistance (PVR). In patients who have remodeling of their pulmonary~     vasculature, PVR will increase with exercise instead of decreasing as it would in normal~     patients. Based on published evidence, the investigators intend to investigate the effects of~     inhaled nitric oxide (iNO) on patients undergoing standard exercise techniques who have~     separately and previously had an implanted pulmonary artery monitoring device (CardioMems by~     St Jude Medical, Inc.) placed.~   "
63563|NCT02734940|"~     The investigators objective is to assess the effectiveness of an opioid sparing multimodal~     approach for enhancing the recovery in Cardiac Surgical patients. This model would use a~     combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine)~     drugs.~   "
63564|NCT02734927|"~     In order to control a behaviour, investigators need to realise goal directed actions and to~     priories some actions. This control is required in unusual situation. Appropriate actions are~     selected and coordinated according to context and aim.~      Several studies try to draw a model of executive function. Recently, Koechlin has suggested a~     three levelled organisation to explain how the prefrontal cortex controls actions.~      Contextual control is useful to answer appropriately with the immediate context. Episodic~     control allows selecting the action according to specific information given before. Sensorial~     control is the automatic response when a stimulus is presented.~      Some diseases like schizophrenia are associated with neurological dysfunction in prefrontal~     cortex. Chambon and al (2008) have identified a dysfunction of contextual control in~     schizophrenia.~      As the prefrontal cortex is involved in motivational process, it seems interesting to study~     potential links between executive function and motivation. A study from Kouneiher shows~     contextual and episodic activation of motivation in healthy population.~      Investigators aim to study the way motivational process are recruited in schizophrenia.~   "
63565|NCT02734914|"~     This study evaluates the safety and efficacy of the suctioning flexible ureteroscopy(SF-URS)~     with automatic control of renal pelvic pressure for the treatment of upper urinary calculi~     using a prospective, randomized design. Half of participants will receive suctioning flexible~     ureteroscopy with automatic control of renal pelvic pressure, while the other half~     participants will receive retrograde intrarenal surgery using the classic flexible~     ureteroscopy.~   "
63677|NCT02733458|"~     The purpose of this study is to evaluate the efficacy and safety of gemcitabine, etoposide,~     pegaspargase and dexamethasone (GELAD) chemotherapy and sandwiched radiotherapy as first-line~     treatment in patients with de novo stage IE/IIE extranodal natural killer/T-cell lymphoma,~     nasal type.~   "
63678|NCT02733445|"~     The purpose of this study was to determine how often and how likely patients are to develop~     Type 2 Diabetes or high cholesterol/lipids when receiving dasatinib or nilotinib as therapy~     for Chronic Myelogenous Leukemia (CML).~   "
63566|NCT02734901|"~     Accumulating evidence from epidemiological and human intervention studies indicates that the~     cardiovascular health benefits of diets rich in fruits and vegetables are (in part) related~     to their (poly)phenol content. Raspberries are rich in phenolic and polyphenolic compounds,~     in particular procyanidins, ellagitannins and anthocyanins, but also phenolic acids. At~     present, a small number of randomized controlled trials investigating the effects of berry~     (poly)phenols on validated surrogate markers of cardiovascular disease risk have shown~     promising results. However, to date, very few human studies have specifically investigated~     the effects of raspberry (poly)phenols on cardiovascular function in healthy subjects.~     Moreover, ellagitannin-derived metabolites are believed to persist for a long period of time~     in the blood and urine. Therefore, the investigators will investigate the presence of plasma~     and urinary raspberry-derived metabolites 24h post-consumption. To the investigators~     knowledge, the effects of red raspberry consumption on vascular function in humans have not~     been investigated before. This information is necessary for the planning of long-term studies~     aiming to assess the potential beneficial effects of raspberries,. Therefore, this study aims~     to investigate the potential role of red raspberry (poly)phenols in the modulation of~     vascular function by monitoring changes in vascular function together with the major~     (poly)phenol derivatives/metabolites in plasma.~   "
63567|NCT02734888|"~     Arterial inflammation will be compared using PET scanning in 3 groups: 1) Non-smokers, 2)~     Tobacco cigarette smokers, 3) Electronic cigarette users.~   "
63568|NCT02734875|"~     This stepped wedge randomized intervention will apply machine learning algorithms in an~     electronic health record system to identify primary care patients with non-valvular atrial~     fibrillation (AF) who are at high risk of stroke and not on anticoagulation therapy. An~     Anticoagulant Management Service (AMS) will offer support to primary care providers regarding~     treatment for relevant patients (either warfarin and novel oral anticoagulants).~      This study seeks to:~        1. increase the proportion of appropriately anticoagulated patients with AF,~        2. understand the reasons for lack of anticoagulation, and~        3. document the proportion of patients with AF who are appropriately not anticoagulated~          (e.g. patient refusal, contraindication).~   "
63569|NCT02734862|"~     The purpose of this study is to determine if intravenous CD101 is safe and effective in the~     treatment of candidemia and/or invasive candidiasis when compared to caspofungin (followed by~     oral fluconazole).~   "
63570|NCT02734849|"~     This is a phase 2 study to evaluate multiple doses of AK001 across 2 active doses.~     Pharmacodynamic activity will also be evaluated.~   "
63571|NCT02734836|"~     This is a prospective, nonrandomized, single-arm study using the Zilver PTXTM stent in~     patients with Superficial Femoral Artery (SFA) disease (total occlusions or significant~     stenosis). 20 patients will be enrolled if they have claudication and/or critical limb~     ischemia, and identifiable SFA disease on angiogram requiring percutaneous peripheral~     intervention (PPI). We would like to study the vessel apposition and expansion immediately~     after initial implantation as well as evaluation of late stent malapposition and neointimal~     hyperplasia at the 12 months follow up after Zilver PTXTM stent implantation using~     intravascular OCT imaging. Follow up visits will take place at 1 month, 6 month, 12 month and~     13 month after the procedure.~   "
63572|NCT02734823|"~     This pilot research trial studies the long term effects of tyrosine kinase inhibitor therapy~     on ovarian reserve and fertility in patients with chronic myeloid leukemia or~     gastrointestinal stromal tumor. Studying ovary imaging, ovarian reserve markers, and hormone~     levels from patients receiving tyrosine kinase inhibitor therapy may help doctors learn more~     about the effects of tyrosine kinase inhibitor therapy on ovarian function and fertility.~   "
63573|NCT02734810|"~     Liprotamase consists of 3 soluble, non-porcine digestive enzymes, lipase, protease, and~     amylase, combined in a fixed ratio. Liprotamase is stable in the stomach and can be~     formulated without enteric coating for administration either as a capsule or as a dosing~     solution dissolved in water or juice. The purpose of the present study is to provide efficacy~     and safety data for a new, soluble formulation of liprotamase, Liprotamase Powder for Oral~     Solution, in Cystic Fibrosis patients with exocrine pancreatic insufficiency (EPI).~   "
63574|NCT02734797|"~     Children who receive hematopoietic cell transplants (HCT) are at high nutritional risk due to~     comorbidities and complications that are likely to develop before, during and after~     transplant. Prior to transplant, many children undergo multiple rounds of chemotherapy which~     affect appetite and cause gastrointestinal toxicities that limit food intake. During~     transplant, painful mucositis makes it difficult to consume adequate nutrients and often~     children will require nutrition support such as parenteral or enteral nutrition. Energy~     imbalance and physical deconditioning following transplant can result in loss of lean body~     mass and functional impairment; these nutritional side effects are exacerbated if the child~     develops graft-versus-host disease. After transplant, a substantial number of childhood~     cancer survivors become overweight and develop metabolic syndrome. However, little is known~     about the prevalence and distribution of pediatric malnutrition (under-nutrition as well as~     obesity), the psychosocial factors that affect dietary intake and how the quality of the~     child's food intake and physical activity level throughout the transplant process might~     affect body composition and clinical outcomes. In this exploratory study, we will monitor~     nutritional status in pediatric patients undergoing HCT. This study will test the feasibility~     of collecting patient-reported dietary intake data along with anthropometric, body~     composition, functional status and psychosocial measurements that may influence dietary~     intake in pediatric patients undergoing HCT. The data collected in this preliminary analysis~     will inform future interventional studies.~   "
63619|NCT02734212|"~     Veterans with PTSD report that stigma and fear of stigma have a chilling effect on their~     participation in mental health treatment. Despite the widely-documented effects of stigma on~     the recovery of individuals with mental illnesses and research demonstrating harmful~     consequences of internalized stigma, including decreased hope, self-esteem, personal~     motivation, and persistence regarding illness management, no interventions are currently~     available to assist Veterans with PTSD in combating the impact of internalized stigma. The~     goal of this research is to develop and pilot-test an intervention to provide Veterans with~     PTSD the skills to cope effectively with stigma and to mitigate the internalization of~     stigmatizing beliefs and stereotypes. To accomplish this purpose, Ending Self Stigma (ESS),~     an intervention composed of evidence-based methods for combating internalized stigma for~     serious mental illness, will be modified and tested to address issues particular to PTSD.~   "
63575|NCT02734784|"~     Chronic periodontitis (CP) is an infectious disease resulting in inflammation of the~     supporting structures of the teeth, progressive loss of bone loss and insertion. The aim of~     this study is to evaluate the effects of antimicrobial Photodynamic Therapy (aPDT) as~     adjuvant to periodontal surgery treatment (PST) in patients diagnosed with generalized severe~     chronic periodontitis (GSCP). Twenty patients with a clinical diagnosis of CP will be treated~     in a split-mouth design study to either aPDT associated with surgical access for scaling and~     root planning (SASRP) or SASRP only. aPDT will be performed by using a laser light source~     with 690 nm wavelength associated with a phenothiazine photosensitizer. The applications will~     occur in only one episodes. All patients will be monitored for 30 and 90 days after PST.~     Clinical assessment of plaque index, probing depth, clinical attachment level and bleeding on~     probing will be performed at baseline (pre-intervention period) and 30 and 90 days after the~     PST. Subgingival plaque samples will be collected (at baseline and 30 and 90 days after the~     PST) and the counts of 40 subgingival species will be determined using DNA-DNA checkerboard~     hybridization. Data obtained will be statistically analyzed.~   "
63576|NCT02734771|"~     This is a study incorporating brentuximab vedotin and dose attenuated rituximab,~     cyclophosphamide, doxorubicin, and prednisone (R-CHP) into initial therapy for elderly~     patients with DLBCL. Vincristine will be omitted from the standard R-CHOP regimen given the~     overlapping toxicities with brentuximab vedotin.~   "
63577|NCT02734758|"~     This study will evaluate whether a gene marker can improve the identification of atrial~     fibrillation in patients with ischemic stroke, and evaluate whether the decision to~     anticoagulate could be improved by a marker of atrial fibrillation.~   "
63578|NCT02734745|"~     This is an open-label, mono-centre, interventional study.The aim of this trial is to assess~     accuracy and reliability of a flash glucose monitoring system, the freestyle Libre (Abbott,~     CA, USA), in patients with type 1 diabetes.~   "
63579|NCT02734732|"~     This study will examine if a single dose of Ciprofloxacin and Trimethoprim/Sulfamethoxazole~     are equivalent for prophylaxis immediately prior to prostate biopsy, when a patient has a~     suspected prostate cancer.~   "
63580|NCT02734719|"~     Bonestim system for osteoporosis treatment uses surface electrical stimulation of~     neuromuscular and skeletal tissue by multipad stimulation electrodes for inducing~     contractions of the spinal column muscles. The primary aim of this clinical study is to~     determine if the Bonestim therapy can improve bone density. A secondary aim is to determine~     whether the applied treatment increases postural stability and facilitation of daily life~     activities.~      Inducing of contractions of the spinal column muscles in this manner could be new treatment~     options for the patients with reduced mobility and the patients with serious~     contraindications for drugs.~   "
63581|NCT02734706|"~     To investigate the effect of a supplement capsule containing LRC™ (L. reuteri NCIMB 30242),~     taken twice daily with lunch and dinner (NLT 2.5E9 CFU per dose), versus placebo capsule on~     serum low density lipoprotein (LDL)-cholesterol in otherwise healthy hypercholesterolemic~     adults after 9 weeks of product consumption.~   "
63582|NCT02734693|"~     A study to evaluate the efficacy and safety of dasotraline in children 6 years of age to 12~     years of age with Attention-Deficit Hyperactivity Disorder (ADHD) in a simulated classroom~     setting.~   "
63583|NCT02734680|"~     The purpose of this study is to find the best model of combination of intraoperative~     radiotherapy(IORT) and postoperative radiochemotherapy for pancreatic cancer.~   "
63584|NCT02734667|"~     The purpose of this study is to learn about the impact of continuous glucose monitoring (CGM)~     on families with newly diagnosed children with type 1 diabetes (T1D). The investigators hope~     to learn about how continuous glucose monitoring affects glycemic variables and~     diabetes-related distress.~   "
63585|NCT02734654|"~     Background: In patients undergoing lung lobectomy, lung collapse and re-expansion after~     resection is associated to severe oxidative lung injury. The researchers hypothesized that~     remote ischemic preconditioning (RIPC) could reduce oxidative lung injury and improve the~     oxygenation parameters.~      Methods: We designed a single-centre, randomized, prospective and double-blind study,~     conducted in fifty-three patients with non-small cell lung cancer undergoing elective lung~     lobectomy.~      Fifty-three patients were randomly assigned to 2 groups: 26 patients received limb RIPC (3~     cycles: 5 min ischemia/5 min reperfusion induced by an ischemia cuff applied on the thigh)~     and 27 controls.~      Time course of oxidative stress marker levels was simultaneously studied in exhaled breath~     condensate (EBC) and blood at four specific time points: T0, pre-operatively; T1, during~     operated lung collapse and one-lung ventilation (OLV); T2, immediately after resuming~     two-lung ventilation (TLV); T3, 120 min after resuming TLV.~      EBC 8-isoprostane was the primary outcome. Secondary outcomes included PaO2/FiO2, other~     pulmonary oxygenation variables, other oxidative markers (NO2-+NO3-, H2O2) and pH.~   "
63586|NCT02734641|"~     The purpose of this study is to examine whether iron therapy in patients with intravenous~     iron deficiency anemia causes an increase in appetite. And whether this increase is mediated~     by the hormone ghrelin.~   "
63587|NCT02734628|"~     The objective of the study was to investigate the efficacy of Bepanthen® wound healing~     ointment compared to placebo in a superficial abrasive wound model. The primary objective was~     the re-epithelization at Day 5.~      The secondary objectives were re-epithelization at Days 2, 3, 4, 6, 7, 8, 9, 10 and 15,~     assessment of cosmetic outcome/acceptance at Day 15 (investigator only) and at Day 36~     (investigator and subject), and documentation and analysis of safety parameters.~   "
63588|NCT02734615|"~     To characterize the safety and tolerability, identify recommended doses and regimens for~     future studies, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of~     LSZ102 as a single agent and in combination with either LEE011 or BYL719 in adult patients~     with locally advanced or metastatic ER+ breast cancer who have progressed after endocrine~     therapy.~   "
63620|NCT02734199|"~     This study aims to understand the long-term health, social, and economic impacts of~     transitioning a community to Highly Effective Reversible Contraception (HER-C).~   "
63679|NCT02733432|"~     The purpose of this study is to determine if two topical formulations of CD101 are safe and~     effective in the treatment of acute moderate to severe vulvovaginal candidiasis (VVC)~     compared to oral fluconazole.~   "
75840|NCT02574260|"~     The primary objective of this extension study was to further assess the safety and~     tolerability of talimogene laherparepvec. Secondary objectives were to assess objective tumor~     response rate and survival.~   "
63590|NCT02734589|"~     Changing the microbiota has become the most intriguing target for intervention in~     inflammatory bowel disease (IBD). Dietary therapy is successful in mild to moderate Crohn's~     disease and may be effective in mild to moderate ulcerative colitis (UC) as well, though~     dietary interventions in UC are just getting underway. However these interventions are less~     likely to be effective for the more severely inflamed or refractory end of the spectrum.~     Fecal transplantation (FT) has been suggested as a method to treat refractory IBD, but most~     studies have been unsuccessful in establishing remission and especially prolonged remission.~     The investigators hypothesize that this is due to selection of random donors and the~     inability to maintain an optimal microbiota eco system post transplant. Diet is a powerful~     tool to modulate the microbiota. The investigators propose to modify FT using a novel~     protocol and approach that we have developed. We have developed a unique diet that is geared~     to rectify dysbiosis in UC and damage to the mucous layer in active UC. The investigators~     intend to condition both donor and recipient with the diet to achieve optimal conditions for~     transplant to succeed for both donor and recipient .The investigators intend to evaluate this~     protocol in adults with active UC that are refractory to medications. The investigators will~     start with a randomized controlled trial involving 76 transplanted patients, however in the~     first pilot stage The investigators will enroll 34 patients, and extend the study if there is~     a trend for better outcomes with the dietary conditioning protocol. Furthermore, The~     investigators hope to identify successful donors during this period to use during the study~     extension.~   "
63591|NCT02734576|"~     There have been few published studies that examine the efficacy and safety of endovascular~     treatments on patients with pulsatile tinnitus with venous stenosis. Despite the limited~     experience with venous sinus stenting to treat pulsatile tinnitus, preliminary results show~     that venous sinus stenting could represent a viable alternative for refractory pulsatile~     tinnitus patients with venous sinus stenosis. The purpose of our study is to evaluate the~     safety and efficacy of this procedure in a controlled fashion, using strict inclusion and~     exclusion criteria, and long-term clinical and imaging follow-up. The investigators hope to~     provide robust data regarding the safety and efficacy of venous sinus stenting for patients~     with pulsatile tinnitus.~   "
63592|NCT02734563|"~     The aim of this study was to evaluate collagen turnover in patients with multiple hernias~   "
63593|NCT02734550|"~     This prospective randomized multicenter study evaluates whether the decision to prescribe~     antifungals guided by (1,3)-β-D-glucan in comparison to standard of care shortens time to~     antifungal therapy and reduces mortality in patients with severe sepsis or septic shock and a~     high risk of invasive candida infection.~   "
63594|NCT02734537|"~     This phase II trial studies how well radiation therapy with or without cisplatin works in~     treating patients with stage III-IV squamous cell carcinoma of the head and neck who have~     undergone surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink~     tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the~     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. It is not yet known if radiation therapy is more effective with~     or without cisplatin in treating patients with squamous cell carcinoma of the head and neck.~   "
63595|NCT02734524|"~     The main purpose of this study is to explore if the combination of autologous NK cell~     infusion and chemotherapy can increase the therapeutic efficiency in the treatment of~     non-small cell lung cancer compared with chemotherapy alone.~   "
63596|NCT02734511|"~     Relieving symptoms of patients hospitalized in a palliative care unit is a priority. Although~     they receive appropriate care, they may still experience pain refractory to analgesia or/and~     to conservative treatment during care procedures. For instance, pain can be caused by the~     bandaging of carcinological or ischemic wounds, or by the mobilization of traumatic injuries~     which cannot be specifically treated.~      Although these types of situations are rare, they remain unacceptable, especially at the end~     of life.~      According to current recommendations, a short-term sedation treatment can be administered~     although detailed procedures for this type of sedation have not been very much documented. In~     reality, midalozam is often used in those cases but it has drawbacks, which is why the~     investigators have looked into alternatives.~      Propofol, which is already widely used in anesthesia and emergency medicine to manage painful~     procedures, seems to be an interesting molecule because of its pharmacological properties. It~     allows to quickly reach deep sedation and thus obtain a certain level of comfort for the~     patient, but also ensures a prompt awakening as soon as care procedures are over, which~     limits respiratory side effects.~      The results from a preliminary study encouraged us to go further and to present a prospective~     study conducted in multiple centers in order to evaluate the efficiency and safety of a~     procedural sedation administered by trained doctors who are not anesthesiologists on~     terminally ill patients with refractory pain hospitalized in a palliative care unit.~   "
63597|NCT02734498|"~     The purpose of this treatment study is to compare the effectiveness of different electrode~     placements used in Electroconvulsive Therapy (ECT) in the treatment of catatonia. In this~     study Electroconvulsive Therapy will be compared to medications used in the treatment of~     catatonia. Medications will be administered by the primary team as part of standard of care.~     Medications are not primarily being used as a part of this research study.~      This treatments study, will be able to compare response rate of catatonia to right unilateral~     electroconvulsive treatment (RUL ECT) and Bilateral electroconvulsive treatment (BL ECT).~     Also having a control group of catatonia patients, which will not be treated with ECT will~     provide additional information on early ECT treatment of Catatonia.~   "
63598|NCT02734485|"~     Background: Progressive supranuclear palsy (PSP) is a rare neuro-degenerative disease,~     counted among atypical parkinsonism (AP). Medical treatment and rehabilitation are extremely~     limited in AP, therefore it would be very useful to find new ways to improve motor and non~     motor symptoms in PSP. The Brainway Deep Transcranial magnetic stimulation (DTMS) is a new~     technology of TMS using a particular coil, i.e. H-coil, able to stimulate deeper regions of~     the brain. Only few studies in literature have evaluated the efficacy of DTMS in Parkinson's~     Disease and parkinsonism; in particular in PSP patients, a case report showed an improvement~     in language.~   "
63630|NCT02734069|"~     This study evaluate the association of body composition (mainly free-fat mass), clinical and~     biochemical parameters with development of toxicity in patients under treatment with~     Carboplatin/Paclitaxel in advanced NSCLC.~   "
63599|NCT02734472|"~     Essential hypertension is a complex trait which results from interaction between~     environmental factors and genetic factors. The aim of this study is to investigate the~     effects of interaction between environmental factors and genetic factors on long-term blood~     pressure (BP) based on two established cohorts including the cohort of Hanzhong adolescent~     hypertension study and the cohort of Mei county adult salt-sensitive hypertension study.~     Firstly, the Hanzhong cohort-based follow-up study is designed to observe the track of BP~     during the whole life time, and to explore the effects of many risk factors (such as~     salt-sensitivity, obesity et al) on long-term BP and the occurrence of hypertension, and also~     to analyze the relationship of different polymorphisms of sodium and potassium~     metabolism-related gene with BP changes and target organ damages. In addition, by using DNA~     samples collected from subjects of Mei county adult salt-sensitive hypertension studyin~     which all participants had completed a chronic salt loading and potassium intervention trial,~     we attempt to examine the single nucleotide polymorphisms (SNPs) of sodium and potassium~     metabolism-related genes, as well as the relationship between these SNPs and BP responses to~     dietary sodium/potassium intervention, long-term BP change, the risk of hypertension and~     target organ damages were analyzed. This study would enable us to further explore the~     etiology of essential hypertension as well as to identify new genetic markers for predicting~     early hypertension and target organ damage.~   "
63600|NCT02734459|"~     Each patient will be randomized to receive one dose of the test article in one eye and one~     dose of the reference formulations in the contralateral eye. One eye will be selected as the~     initial eye for cataract surgery and aqueous humor collection and hence will be dosed and~     operated on first. Followed by the second eye which will be dosed no early than a week~     followed by aqueous humor collection as per specified time points and no later than 35 days~     following the first eye again prior to the cataract surgery.~   "
63601|NCT02734446|"~     The purpose of this project is to evaluate in a randomized clinical trial, double-blind,~     controlled, the effects of a dietary supplement containing Lactobacillus reuteri DSM 17938~     and vitamin D3 in reducing bronchial inflammation and improve asthma control in patients in~     children with mild / moderate persistent asthma .~   "
63602|NCT02734433|"~     This is a Phase I, non-randomized, open-label, multiple dose study of pexidartinib in Asian~     subjects with advanced solid tumors. The study will be conducted in a dose escalation to~     assess the safety and tolerability, pharmacokinetics (PK) and pharmacodynamics (PD), and~     preliminary antitumor activity of pexidartinib.~   "
63603|NCT02734420|"~     The aim of the proposed study is to assess the clinical effect of photodynamic therapy (PDT)~     on dentin with carious lesions in primary teeth. Patients with primary molars exhibiting deep~     carious lesions on the occlusal surface indicated for restorative treatment will be randomly~     allocated to three groups: Group 1 - traditional caries removal with a low-speed drill; Group~     2 - PDT + PapaMblue (carious tissue removal agent) modified with methylene blue; and Group 3~     - PDT with methylene blue 0.05%. PDT will be performed with low-level laser for the treatment~     of the carious tissue. Dentin samples will be removed before and after PDT for~     microbiological analysis. The microbiological samples will be cultured in Brucella blood~     agar, Mitis Salibarius-bacitracin agar and Rogosa SL agar. The teeth will then be restored~     using high-viscosity glass ionomer cement, with clinical and radiographic follow up at six,~     12 and 24 months. The data will be submitted to descriptive statistics.~   "
63604|NCT02734407|"~     The Endurance Trial is a Phase IV open label clinical study to assess the need for ongoing~     intravitreal aflibercept injections after the 3-year VISTA DME (VGFT-OD-1009) endpoint.~     Subjects will be treated with intravitreal aflibercept injections pro re nata (PRN) based on~     the presence of CR-DME (Clinically Relevant-DME). In addition, subjects who meet re-treatment~     criteria will be eligible for focal laser treatment every 90 days~   "
63605|NCT02734394|"~     The purpose of this project is to help to manage the many cancer treatment side effects~     through cardiovascular and resistance exercise, and education with the goal of using program~     outcomes to contribute to current research.~   "
63606|NCT02734381|"~     The number of elderly patients admitted to the Emergency Department (ED) is dramatically~     increasing.~   "
63607|NCT02734368|"~     The purpose of this study is to determine the MRI characteristics of Chronic Obstructive~     Pulmonary Disease subjects both at baseline and yearly for a period of 5 years, and to~     correlate these biomarkers with pulmonary function tests, CT scan, 6 Minute-walk tests, and~     respiratory questionnaires.~      The central hypothesis is that quantitative assessment of the lung through magnetic resonance~     imaging of hyperpolarized 3He can detect early alterations in structure and function which~     are precursors to clinically apparent COPD and that these precursors can be used to predict~     progression of disease earlier and better than established clinical methods.~      Novel assessments using 3He MRI will lead to new information about COPD and will be critical~     for characterizing disease response to therapy. A secondary hypothesis is that a variety of~     technical improvements in the techniques of hyperpolarized gas MRI will accelerate the~     translation of this relatively new modality to clinical use.~   "
63608|NCT02734355|"~     The objective of the study was to estimate the efficacy of telmisartan and amlodipine~     combination on the restoration of left atrial mechanical function after atrial fibrillation~     catheter ablation.~   "
63631|NCT02734056|"~     Patient satisfaction is becoming increasingly important to hospital administrators as a~     metric for quality of patient care services because it is now being linked to reimbursements~     (Maher 2015). Patient satisfaction is a complex problem, and may be affected by a variety of~     factors. A recent study found that higher patient satisfaction was associated with patients~     who received music therapy during their hospital stay (Mandel 2014). Given that music may~     positively affect patient satisfaction, we are designing a study to examine the effects of~     patient-preferred music on patient satisfaction in women undergoing labor epidural placement.~   "
63632|NCT02734043|"~     The objective of the study is to provide a road map that can help organizational leaders~     understand how to sequence their financial and human capital investments related to bundled~     payment arrangements. Although specific strategies will vary between organizations, providing~     evidence from a health system with extension experience bundling care for orthopedic joint~     replacements can be instructive for other providers entering new building arrangements.~     Insights from the experience of the health system can help other organizations prioritize~     effort and focus energy around strategies that increase the likelihood of succeeding under~     Comprehensive Care for Joint Replacement (CJR) and other bundled payment contracts.~   "
63609|NCT02734342|"~     Osteoarthritis (OA) is a condition that causes cartilage loss, bony remodeling, joint~     stiffness and generalized muscle weakness. 90% of OA presentation has been reported within~     the leg; with 44% affecting the knee joint. Knee OA is expected to increase by 50% over the~     next twenty years due to an ageing population, obesity, and societal trends such as lack of~     activity. Only 13% of knee OA sufferers reach the recommended levels of exercise therefore an~     understanding of how psychological and functional relationships effect exercise engagement,~     which in turn would provide a more comprehensive rehabilitation programme for patients with~     knee OA. The aim of this study is to investigate exercise in knee OA and it it's correlation~     with fear of movement, using a mixed methods approach. Quantitative methodology will~     investigate lower limb exercises for pain and function and fear of movement. The desired~     outcome of the study will show that a reduction in pain with patient specific exercise will~     also reduce the fear of movement and allow patients to self-manage their symptoms without~     fear. Other quantitative factors such as intensity of exercise and postural stabilization~     using the Y balance test will also be utilized to review the functional relationship of~     muscle strength and balance to kinesiophobia. A semi-structured interview will be completed~     at the end of the course of treatment to highlight what patients think about exercise as an~     intervention. Participants aged forty-five and above with specific clinical symptoms will be~     invited into the study and will be asked to attend eight exercise sessions within a class~     environment, which will last for 1 hour within the Physiotherapy Department.~   "
63610|NCT02734329|"~     Zero ischemia laparoscopic radio frequency ablation assisted tumor enucleation has been~     proved to enable tumor excision with relatively better renal function preservation comparing~     with conventional laparoscopic partial nephrectomy for T1a renal cell carcinoma (RCC) in a~     randomized clinical trial in single center. The investigators want to explore this technique~     to T1 RCC patients in randomized clinical trial in multiple centers.~   "
63611|NCT02734316|"~     The use of Direct Oral Anti-Coagulants (DOACs) is expanding, but their proper management in~     patients undergoing endoscopic procedures is still not completely clear. Current European~     guidelines are based on weak data. This observational study aims to evaluate the~     peri-endoscopic management of DOACs in clinical practice and the incidence of adverse events.~   "
63612|NCT02734303|"~     Background:~      The first nuclear bomb test took place in New Mexico in July 1945. This was called the~     Trinity test. Researchers want to learn how it affected the health of people who lived in New~     Mexico at the time of the test. To do this, they want to learn about the diet and daily life~     of those people at that time. They want to study Native Americans, Hispanic/Latinos, and~     non-Hispanic/Latino whites.~      Objective:~      To learn about the health risks for people who may have been exposed to radiation from the~     Trinity nuclear test.~      Eligibility:~      People who:~        -  Are Native American, Hispanic/Latino, or non-Hispanic white~        -  Are age 70 and older~        -  Lived near the fallout region of the Trinity test and know about lifestyle and dietary~          patterns in New Mexico in the 1940s and 1950s~      Design:~      Participants will be screened with a questionnaire.~      Participants will answer questions in an interview or a focus group. This will be at a place~     like an office, tribal or community center, or library. It will take up to 2 hours. The~     interview or group session will include:~        -  Questions about their and their family members activities and eating habits in the 1940s~          and 1950s~        -  A card-sorting exercise: There will be cards with pictures and names of certain foods.~          They will sort the cards into 2 piles: those that were consumed and those that were not.~        -  Filling out a chart of their family members and the foods they ate~      If participants give permission, their interview or group session will be recorded.~   "
63613|NCT02734290|"~     The goal of this study is to establish the safety and tolerability of pembrolizumab when~     administered in combination with either of two chemotherapy regimens (weekly paclitaxel or~     capecitabine) in unresectable/metastatic triple negative breast cancer (MTNBC) patients.~   "
63614|NCT02734277|"~     To further our understanding of the immunologic mechanisms underlying maintenance and loss of~     beta cell function by evaluating the relationship between longitudinal changes in beta cell~     function and changes over time in biomarkers known to be associated with a response to immune~     modulating treatments which were used in prior clinical trials (Refer to ClinicalTrials.gov~     records NCT00129259 and NCT00965458).~   "
63615|NCT02734264|"~     The purpose of this study will be to investigate the incidence of both Amebiasis and~     cryptosporidiosis in Bangladeshi children and examine genetic variation in innate and~     adaptive immunity with respect to these infections. Novel diagnostics to these infections~     will also be investigated.~   "
63616|NCT02734251|"~     The present randomized, double-blind, placebo-controlled crossover trial aims to evaluate the~     effects of Relora supplementation on responses to induced stress produced by a combination of~     cognitive and physiologic stressors in healthy men and women. The effects of the supplement,~     compared with a placebo, will be evaluated using measures to assess anxiety [State-Trait~     Anxiety Inventory-Part 1 (STAI-Part 1), mood [Bond-Lader Visual Analog Scale (VAS)],~     hypothalamic-pituitary-adrenal axis activation (salivary cortisol) and cognitive function~     (cognitive flexibility, reaction time, processing speed, attention, sustained attention,~     working memory, and executive function). Testing will be completed at the beginning and end~     of 7-d supplementation periods with the active and placebo products to assess both the acute~     effects and the acute-on-chronic effects following one week of daily use.~   "
63617|NCT02734238|"~     The objective of this study is to determine whether maintaining a eugonadal state, during~     severe, sustained energy deficit, attenuates physiological decrements, particularly the loss~     of lean body mass, and maintains mental performance.~   "
63618|NCT02734225|"~     Knee osteoarthritis produces degeneration and joint wear that greatly affects the patient's~     proprioceptive system increasing instability. After total knee arthroplasty intervention, it~     is recommended that the patient performs a rehabilitation procedure to minimize deficits~     caused by surgery. In this job it is essential to insist on the importance of recovering~     balance after total knee arthroplasty intervention, and assess a specifically designed~     protocol to restore its function. An intervention which includes a dynamometric platform as a~     training method was proposed. The randomized clinical trial compared a control group that~     performed balance exercises on parallel bars, unstable plates, ramps and stairs against an~     experimental group that included dynamometric platforms training as a differentiator.~   "
63621|NCT02734186|"~     Background:~      Schistosomiasis is a chronic infection. It is caused by parasitic worms called Schistosoma~     haematobium (Sh) that are spread by snails that live in rivers. It can lead to liver problems~     or bladder cancer. Praziquantel (PZQ) is a drug used to treat this infection. After taking~     it, some people develop increased resistance to reinfection with Sh. Some people with Sh~     infection can be infected with another worm called Mansonella perstans (Mp). Mp is spread~     through a biting insect called a midge. It rarely causes symptoms. However, researchers think~     that Mp infection could affect the body s response to PZQ treatment for or risk of~     reinfection with Sh.~      Objective:~      To find out the effects of Mp infection on the response to PZQ treatment for Sh infection.~      Eligibility:~      Men and women ages 14-80 who:~        -  Live in Tieneguebougou, Bougoudiana, or surrounding villages in Mali~        -  Are not pregnant~        -  Have Sh infection~        -  Have no other chronic medical conditions~      Design:~        -  Participants will be screened with:~             -  Medical history~             -  Physical exam~             -  Blood and urine tests~             -  Stool samples~        -  Participants will be treated with a single dose of PZQ by mouth.~        -  After receiving PZQ, participants will return to the clinic for blood and urine tests at~          the following times:~             -  4, 8, 24, 48, and 72 hours later~             -  5, 7, 9, and 14 days later~             -  1, 3, and 6 months later~      Participants who are infected with Sh at the 6-month visit will get another treatment with~     PZQ.~   "
63622|NCT02734173|"~     There is compelling data supporting the pursuit of research into the effects of HCV~     antivirals on metabolic homeostasis. As a further rationale and justification, the experience~     with HIV antiretrovirals has clearly demonstrated that antiviral medications can produce~     profound changes in glucose metabolism, lipid profile and other measures of metabolic~     homeostasis. This establishes biological plausibility for this focus of research in HCV.~      The new knowledge created from this research will:~        1. Provide new information on the metabolic effects of the Abbvie 3D HCV antiviral regimen.~        2. Provide insight as to whether there are metabolic advantages with RBV-free compared to~          RBV-containing HCV regimens. This is particularly relevant given the current uncertainty~          regarding the need for RBV in IFN-free, oral DAA regimens.~        3. Provide insight into the impact of cirrhosis on metabolic milieu before, during and~          after HCV antiviral therapy~   "
63623|NCT02734160|"~     The main purpose of this study is to evaluate the safety and efficacy of the study drug known~     as galunisertib administered in combination with the anti-programmed cell death-ligand 1~     (PD-L1) antibody durvalumab in participants with refractory metastatic pancreatic cancer.~   "
63624|NCT02734147|"~     Despite an organized treatment approach outlined in expert-consensus guidelines for sepsis~     with fluid resuscitation to treat hypovolemia, antibiotics to target the infectious insult,~     and vasopressors for hypotension, mortality rates for sepsis remain high and the incidence~     continues to rise, making sepsis the most expensive inpatient disease.~        1. Recent research has described the therapeutic benefits associated with ascorbic acid~          treatment for sepsis.~        2. Researchers objectives are to perform a randomized-controlled clinical trial~          investigating the ability of ascorbic acid(vitamin C) administration to decrease organ~          dysfunction in severe sepsis. The widespread occurrence of microvascular dysfunction in~          sepsis leading to tissue hypoxia, mitochondrial dysfunction, and ATP depletion, gives~          rise to organ failure.~        3. Patients with organ failure and sepsis (severe sepsis) are at a higher risk of death~          than patients with organ failure alone. Critically ill patients may have an increased~          requirement for ascorbic acid in sepsis and these patients frequently have levels below~          normal. Ascorbic acid administration, has been shown to correlate inversely with organ~          failure (human literature) and directly with survival (animal studies).~      4,5 Intravenous ascorbic acid therapy decreases organ failure by providing a protective~     effect on several microvascular functions including improving capillary blood flow,~     decreasing microvascular permeability, and improving arteriolar responsiveness to~     vasoconstrictors. Defining the utility of novel agents to augment researchers care for severe~     sepsis is an important task as investigators continue the institutional focus on sepsis care.~   "
63625|NCT02734134|"~     The purpose of this study is to compare the outcomes of two different treatment options~     commonly used to manage periprosthetic joint infection (PJI), an infection around the~     artificial knee or hip.~   "
63626|NCT02734121|"~     The purpose of this study is to determine the effectiveness of a pre-consultation decision~     support workshop for breast reconstruction after breast cancer, in facilitating the~     decision-making process, compared to routine pre-surgical education.~   "
63627|NCT02734108|"~     Anorexia nervosa is an eating disorder characterized by intense fear of becoming fat despite~     the obvious thinness and extreme behaviors for weight loss. The result is a massive weight~     loss and / or pathological thinness. The care of anorexia is difficult and few treatments~     have proved to be effective in adults.~      Transcranial direct current stimulation (tDCS) is a neuromodulation technique that uses an~     electrical current of low intensity. It allows to modulate the corticospinal excitability:~     two electrodes, an anode (excitatory) and a cathode (inhibitory), are positioned on the skull~     according to the region which is desired to influence the operation.~      Although tDCS was shown to no noticeable side effects, it is first necessary to assess the~     feasibility and safety of this technique in these physically frail patients. A recent pilot~     study suggests the acceptability, safety and efficacy of tDCS program in patients with~     anorexia nervosa.~      Given these preliminary data and the extreme seriousness and vulnerability of patients with~     resistant anorexia, the investigators want to assess the risk / benefit ratio for the use of~     this technique in patients suffering from resistant anorexia nervosa. The current data are~     too preliminary to consider a randomized controlled trial, the investigators hope, initially,~     replicate the data from this pilot study in a second sample with a more rigorous and~     comprehensive assessment methodology .~   "
63628|NCT02734095|"~     A prospective, single-center, real-world study on intravascular ultrasound measurements after~     percutaneous transluminal angioplasty and stenting in the treatment of femoropopliteal~     lesions.~   "
63629|NCT02734082|"~     Many studies have shown that acute cerebral dysfunction can impair cardiac function and~     autonomic control of blood pressure, heart rate and vascular tone, however, the size of the~     stroke is rarely reported. Involvement of the insular cortex seems to predispose to cardiac~     damage and autonomic dysfunction. However, it is not clear whether cardiac dysfunction is~     merely a marker of large strokes or location of the stroke is critical.~   "
63633|NCT02734030|"~     This study aims to compare the knee extensors' mechanical, morphological and myoelectric~     properties between subjects affected by anterior knee pain and a healthy control group. The~     investigators hypothesis is that patients with anterior knee pain present a reduction in the~     knee extensors' mechanical, morphological and myoelectric properties due to chronic muscle~     inhibition produced by the syndrome. In addition, the study also aims to evaluate whether~     there are differences in methodology for application of the Interpolated Twitch Technique for~     evaluation of the quadriceps muscle inhibition by comparing the use of supramaximal~     electrical stimulation on the femoral nerve (gold standard) with stimulation on the motor~     point (new methodology) in healthy subjects and individuals affected by anterior knee pain.~     The investigators hypothesis is that the stimulation on the motor point is less~     discomfortable than on the femoral nerve and muscle inhibition results are less variable~     (with lower dispersion) due to such lower discomfort~   "
63634|NCT02734017|"~     The study is a randomized controlled clinical trial. A total 1400 hospitalized patients will~     be randomized in two groups:~        1. group receiving a pharmacist-led standardized medication review (experimental group);~          and~        2. group not receiving the medication review (control group).~      The patients will be followed up at 30 days after initial hospitalization. Outcome measures~     include the number of readmissions; patient satisfaction, quality of medical admission~     prescription and number of consultation after initial hospitalization.~      Discussion: A randomized controlled trial will provide the highest level of evidence on the~     impact of pharmacist-led standardized medication review on early hospital readmission for~     extreme age population.~   "
63635|NCT02734004|"~     The purpose of this study is to look at the effectiveness, safety, and antitumor activity of~     study drugs MEDI4736 in combination with olaparib (modules 1, 2, 3, 4, 5 and 7) and MEDI4736~     in combination with olaparib and bevacizumab (module 6). It will also examine what happens to~     the study drugs in the body and investigate how well the combination between MEDI4736,~     olaparib and bevacizumab is tolerated.~   "
63636|NCT02733991|"~     A premarket, international multicenter, prospective, open label, adaptive, randomized~     controlled study.~      The aim is to evaluate the efficacy of sensor augmented pump therapy with MiniMed™640G and~     SmartGuard™in preventing hypoglycemic events in comparison with continuous subcutaneous~     insulin infusion therapy in type 1 diabetes adults with an increased risk of hypoglycemia.~     The primary objective is to demonstrate a reduction in the mean number of hypoglycemic events~     when using the MiniMed™640G system with SmartGuard™ and the secondary objectives will aim at~     evaluating the difference in glycemic parameters and HbA1c.~   "
63637|NCT02733978|"~     Digital ulcers (DUs) in scleroderma result from recurrent Raynaud's phenomenon (RP) and~     microtrauma with high impact on quality of life, management of DUs is a great challenge for~     clinicians. Medical use of ozone (triatomic oxygen) was initiated in the 19th century. Ozone~     has multiple therapeutic effects in wound healing due to the property of releasing nascent~     oxygen, which has been shown to stimulate antioxidant enzymes.~   "
63638|NCT02733965|"~     The improvement of the care pathway of oncology patients through Clinical Pharmacy activities~     for outpatients (such as pharmaceutical consultation) should be implemented and evaluated.~      In order to improve the care pathway of patients on anticancer oral therapies, The~     investigators suggest in this research project to integrate into the medical care a Clinical~     Pharmacy follow-up for the patient at the hospital in the form of pharmaceutical~     consultations. These pharmaceutical consultations carried out in coordination with the~     hospital clinical teams also aim to make the link between the hospital and community~     pharmacists.~   "
63639|NCT02733952|"~     Intravenous Tranexamic Acid Versus Pericervical Tourniquet To Decrease Blood Loss In~     Trans-Abdominal Myomectomy~   "
63640|NCT02733939|"~     This randomized controlled trial aims to recruit a total of 320 dyads composed by persons~     with dementia living in community settings and their primary informal caregivers. In the~     intervention group, persons with dementia will have a home monitoring kit installed in the~     household while participants in the control group will receive their usual care. The kit~     includes home leaving sensors, smoke and water leak sensors, bed sensors as well as automatic~     lights that monitor the individual's behavior. Alerts (text message and/or phone call) will~     be sent to the caregiver if anything unusual occurs. All study participants will receive~     three home visits by project administrators that have received project specific training in~     order to harmonize data collection. These will take place at enrollment and 3 and 12 months~     following installation of the home kits. At every home visit, a standardized questionnaire~     will be administered to all study participants to assess their health, quality of life and~     resource utilization. The primary outcome of this trial is the amount of informal care~     support provided by primary informal caregivers to the Person with Dementia.~   "
63641|NCT02733926|"~     This study evaluates the effect of vegetation cover on certain Interleukin-10 and~     immunoglobulinE (IgE) among children (3-5 y old). Children will either be in a kindergarten~     that does not have forest floor and agricultural land in the backyards, or alternatively they~     will be in a kindergarten that does have forest floor and agricultural land in the backyards.~   "
63642|NCT02733913|"~     Pulmonary vein isolation (PVI) has become a standard therapy for atrial fibrillation (AF),~     however, there is still considerable AF recurrence after PVI. Except for PV-left atrium (LA)~     reconnection, the cause of recurrence has been not yet fully clarified.~      The alternation of autonomic tone plays an important role in initiation of paroxysmal AF. It~     was reported that there are multiple gangliated plexus (GP) around pulmonary veins, therefore~     the modulation targeting those GPs, resulting in modulations of cardiac autonomic tone, have~     been conducted. Some study showed the efficacy of GP ablation for AF patients.~      According to the previous reports, heart rate (HR) increased, and heart rate variability~     (HRV) reduced after PVI. These are considered to be due to autonomic denervation caused by~     catheter ablation of GP.~      For the best of investigators knowledge, there have been no data on heart rate turbulence~     (HRT) of baroreflex sensitivity (BRS) concerning PVI.~   "
63733|NCT02732730|"~     To assess the acceptance rate, adherence, acceptability, and continuation of oral~     pre-exposure prophylaxis (PrEP) among young southern African women.~   "
64193|NCT02726737|"~     The purpose of this prospective, randomized, double blind study was to evaluate the effect of~     a buccal infiltration of sodium bicarbonate on the anesthetic success of the inferior~     alveolar nerve block (IANB) in patients with mandibular first molar experiencing symptomatic~   "
63644|NCT02733887|"~     The lymph nodes or masses,positron emission tomography/computed tomography (PET/CT)~     standardized uptake values(SUV) results, whole body magnetic resonance imaging(MRI)~     intravoxel incoherent motion(IVIM) sequence D, D*, f values and MRI volumes of lymphoma~     patients were compared before and after the chemotherapy in this project prospectively to~     provide data for evaluating the dependency and differences of PET/CT and whole body MRI in~     lymphoma staging and therapeutic evaluation. Long-term therapeutic effect indexes obtained in~     follow-up visits of patients such as Overall Survival(OS), Progression Free Survival (PFS)~     etc. were used to evaluate the diagnostic sensitivity and differences of MRI and PET/CT. The~     research could provide a new method of nonionizing radiation iconography for physicians to~     give appropriate treatments and predict prognosis.~   "
63645|NCT02733874|"~     A multi-center, randomized, single blind, positive controlled trials that assess the~     effectiveness, safety and cost-effectiveness analysis in patients with mild to moderate~     psoriasis vulgaris and compare Compound Clobetasol Propionate Ointment to Calcipotriol~     Betamethasone Ointment.~      Objectives of Study：~        1. Compare Compound Clobetasol Propionate Ointment to Calcipotriol Betamethasone Ointment~          in the treatment of mild to moderate psoriasis vulgaris in effectiveness and safety;~        2. Compare the cost-effectiveness analysis of two treatment programs.~   "
63646|NCT02733861|"~     With the development of oral medicine,dental implants has become a very popular solution to~     remediate the loss of teeth and dental rehabilitation. For the last few decades, the~     immediate loading protocol have become more and more popular because the increasing demands~     of shortened treatment time. Implant stability is considered one of the most important~     parameters in implant dentistry. It affects the healing and successful osseointegration of~     implants. For any implant procedure, successful implant integration is a prerequisite~     criterion, which depends on a series of procedure-related and patient-dependent factors. It~     also has been considered that preoperative measurement is critical and may give valuable~     information to predict loading time and survival of the implants.~      In this clinical study, the samples were collected from patients with single teeth missing~     who came from the department of prosthodontics from the School of Stomatology of the Fourth~     Military Medical University.The prospective cohort study was used to investigate the~     correlation between different factors and the early stability of the implants. And then,~     using the correlation between different factors and the early implant stability gives~     predictable data about implant stability and then evaluate the accuracy and reliability.~   "
63647|NCT02733848|"~     Hypoglycemia is an increasingly recognized complication of Roux-en-Y gastric bypass (RYGB)~     that is poorly understood and difficult to treat. Investigators hypothesize that after RYGB~     some patients have incomplete carbohydrate absorption in the small intestine which leads to~     inconsistent glucose levels and hypoglycemia during oral consumption of a meal. Investigators~     further hypothesize that pancreatic enzyme supplementation with (Creon) during meals and~     snacks will improve carbohydrate absorption and lead to more stable glucose levels in~     patients with post-RYGB hypoglycemia.~   "
63648|NCT02733835|"~     This study is a prospective cohort study aiming to evaluate an improved VPIA remifentanil~     algorithm which would benefit labouring mothers who are unable or unwilling to receive~     epidural analgesia~   "
63649|NCT02733822|"~     Naloxone is the standard treatment in response to cases of suspected opiate overdose.~      Buccal formulation of naloxone is a novel alternative to the licensed naloxone injection~     which, by removing the risk of accidental needle-stick, may be safer and easier to~     administer.~      Current UK policy allows the emergency administration of naloxone by any member of the~     general public (Strang, Kelleher, Best, Mayet, & Manning, 2006), and the preventative~     provision of naloxone to drug users and their family members (take-home naloxone) is~     possible on a prescription basis. Thus, buccal naloxone may be particularly suitable for~     administration by family members who are providing interim overdose management care while~     awaiting the arrival of an ambulance.~      The aim of this study is to examine the bioavailability and dose proportionality of buccal~     naloxone compared with the licensed injection standards (intravenous, intramuscular).~      The investigators hypothesise that buccal naloxone is not inferior to the injection reference~     in absorption kinetics, i.e. time elapsed till peak concentration (Tmax; primary outcome),~     peak plasma concentration (Cmax), overall absorption (AUC), bioavailability (F%) and,~     duration of action (mean terminal half-life; T1/2).~      The investigators propose a pharmacokinetic pilot investigation with within-subjects~     (crossover) design, comparing two doses (0.8 mg; 1.6 mg) of buccal naloxone hydrochloride~     solution to the licensed intramuscular (IM; 0.8 mg) and intravenous (IV; 0.8 mg) routes of~     injection. The investigators will invite four healthy (i.e., non-opioid using) male~     volunteers (n=4, not powered), each of whom will attend four experimental sessions at~     counterbalanced sequence. Each volunteer will receive naloxone hydrochloride doses of 0.8 mg~     IM, 0.8 mg IV, 0.8 mg buccal, and 1.6 mg buccal, with only one dose administered per session.~      Blood concentrations will be measured at selected times during each session to establish~     speed of naloxone absorption, time to peak concentration, estimated half-life, and overall~     bioavailability. This dose-ranging pilot will inform future work by providing preliminary~     data on buccal naloxone absorption into the bloodstream and by establishing feasibility of~     the buccal route for naloxone delivery.~   "
63650|NCT02733809|"~     It has been shown previously that gene expression profiling signature (a set of dysregulated~     genes) can be used for molecular classification, diagnosis, and prognosis of several types of~     cancers. In This study the hypothesise that resistant tumor may be due to genetic mutations~     and/or other alternative pathways that could be the reason to overcome the Sorafenib and~     still proliferate.~      Primary objectives To evaluate the primary and secondary potential mechanisms by which HCC~     patients on Sorafenib treatment would be resistant to therapy and also identify the favorable~     genetic makeup of patients responding to treatment.~      Measures of primary outcome:~        -  cDNA microarray analysis on the MAP kinase pathway.~        -  mRNA quantification of genetic expression (RT-PCR) for identification of upregulated~          genes, and confirmed by corresponding proteomic testing (by Mass Spectroscopy) in the~          serum for potential serum markers. Secondary Objectives Progression free survival: Time~          to disease progression in patients in Saudi Arabia with HCC receiving Sorafenib:~          [defined as time, in weeks, from the baseline visit to progression of the disease or~          death from any cause] will be diagnosed using the RECIST criteria based on a trimestrial~          abdominal CT evaluation.~        -  Survival rates and Predictors of survival:~             -  Survival defined as the time from baseline visit to death from any cause [in~               weeks].~             -  Variables identified in multivariate regression analysis from overall treated~               patients independently associated with survival till study completion or death.~               Justification and Value to the Kingdom Sorafenib in the treatment of advanced HCC~               is a recent development. Since the only current effective treatment for advanced~               HCC is resection or transplantation and the list for these procedures are~               ever-growing due to the confounding effect of the lack of infrastructure in the~               Kingdom, selecting treatment for patients who are more likely to respond to~               Sorafenib treatment The Long-Term Comprehensive National Plan for Science,~               Technology and Innovation will help to reduce costs of managing HCC. Among Saudi~               Arabia population, there are a unique set of patients here (e.g. non-alcohol~               related HCC, genotype 4 HCV patients and genotype D HBV patients, high percentage~               of obese patients i.e. NASH) which is different from other parts of the world.~               There is increasing incidence of HCC in Saudi Arabia. Due to available expertise in~               management of HCC patients in the participating institutions in the study, this~               project will represent a bridge for the transfer of technology so that our research~               staff and doctors will have more expertise in carrying out these techniques~               independently. This study will also run in parallel to the on-going initiative to~               start a HCC biobanking establishment which will provide the samples needed to carry~               out our genetic studies in future. Finally, since the use of Sorafenib (at present,~               the only approved treatment for advanced HCC) in the treatment of advanced HCC is a~               new field, the findings of our study will have important implications in the~               management of HCC, both locally and internationally.~      HCC is the third most common cancer in Saudi Arabia. In 2001, HCC was the second most common~     cancer affecting Saudi males and the eighth most common cancer affecting females. Most of~     patients (90%) present at a more advanced stage when symptoms prevail.~      Given the high prevalence of HCC in the Kingdom, it is pertinent to study why some patients~     are resistant to Sorafenib compared to others. Elucidation of the differences in mechanisms~     among responders and non-responders to Sorafenib therapy will enable physicians to make~     better decisions in terms of treating Saudi HCC patients.~   "
63651|NCT02733796|"~     This is a prospective observational laboratory evaluation of the persistence rate of zika~     virus (ZIKV) infection in semen by real-time Reverse Transcriptase Polymerase Chain Reaction~     (RT-PCR), and assessment of ZIKV replication-competence in semen by isolation of ZIKV.~     Evaluation of the persistence of ZIKV and its replication-competence in semen samples will~     increase the understanding of the risk of sexual transmission of ZIKV infection in the~     post-viremic phase in non-epidemic settings.~   "
63652|NCT02733783|"~     The primary aim of the study is to create a model; in order to examine the effects of neural~     trauma in patients that are healthy individuals, induced by controlled nasal fractures during~     rhinoplasty, and the regeneration process in the weeks/months that follow. This study~     includes monitoring of subjective nasal symptoms with a visual analogue scale (VAS) score,~     peak nasal inspiratory flow (PNIF) measurements, collection of nasal secretions and nasal~     provocation (response to capsaicin and cold dry air (CDA) exposure).~   "
63653|NCT02733770|"~     Obesity if a health endemic problem over the entire world. Bariatric surgery is the best~     chance for those patients with morbid obesity to loss weight and to maintain the loosed~     weight.~      Metabolic surgery is the new name for bariatric surgery like sleeve gastrectomy and gastric~     by pass due to the recognized changes in the homeostasis of the hormonal secretion responsive~     to the hunger status. After sleeve gastrectomy we observe many patients with thrombus of the~     portal vein system. This phenomena may be attributed to changes in the portal flow due to~     devascularization of the great curvature of the stomach.~      The aim of the study is to compare the portal flow by intra-operative Doppler ultrasound~     before and after surgery of the two procedures as sleeve gastrectomy and gastric bypass, were~     the vascularization is not changed by the surgery.~   "
63656|NCT02733731|"~     Objective：To evaluate the effect and safety of the traditional chinese medicine oil agent on~     senile atrophic compared as compared to estriol cream in aged woman.~      Design: A randomized double-blind controlled trial.~      Setting: The hospital ward.~      Participants: 200 postmenopausal woman with senile vaginitis (mean age 56).~      Intervention: The traditional chinese medicine oil and estriol cream were separately~     intravaginal administrated in treatment group and control group for 3 weeks，follow-up 1~     month.~      Measurement: symptom improving(pain and itch) and onset time, edema-size of vaginal wall,~     vaginal discharge, and PH changes.~   "
63657|NCT02733718|"~     This study aims to compare the differences between three different feeding regimens on~     intestinal oxygenation during packed red blood cell (PRBC) transfusion in premature babies.~   "
63658|NCT02733705|"~     Nowadays, TRUS biopsy become one of the most popular tests for diagnosis of prostate cancer.~     This procedure causes pain to the patients who does not received the sedative drugs or~     analgesic drugs. There are many ways to reduce pain and inconvenience for the patients, such~     as intravenous propofol, intravenous fentanyl etc. In Siriraj hospital, anesthesiologists~     usually give intravenous propofol with intravenous opioids but the visual analogue score~     after this procedure was average at 0.9-2.9. Furthermore, some systematic reviews have shown~     that there was no difference in pain score between periprostatic nerve block plus opioid and~     periprostatic nerve block only. So, this study is to find out whether opioids is need for~     TRUS biopsy.~   "
63659|NCT02733692|"~     Smartphone applications and mobile technologies offer users the potential to access critical~     information (e.g., proper condom use, directions to testing sites, and other sexual and~     reproductive health services) when it is needed most. Relevant findings will identify areas~     where existing interventions may be leveraged and adapted to work among young women of color~     in an urban setting and their networks. As SRH smartphone apps continue to proliferate, this~     study will expand researchers', developers', and health educators' limited knowledge about~     the feasibility, acceptability and preliminary efficacy of a sexual health educational app~     tailored with and for young Black and Latino women, aged 18-25 in NYC, including whether this~     app acts as a gateway to sexual health educators, clinical and other service providers. If~     proven effective, findings from this study will identify areas where existing interventions~     may be leveraged and adapted to work among a YBLW and their networks, and potentially adapted~     for other high needs communities.~   "
63660|NCT02733679|"~     This study aims to investigate the link between the Ataxia Telangiectasia Mutated (ATM) gene~     and metformin response. This link has been identified from large studies of the human genome,~     and this study aims to confirm this link in a clinical study. The ATM gene is involved in DNA~     repair - if a person inherits a faulty copy of this gene from both their parents, they have~     a genetic condition called Ataxia-telangiectasia (A-T).~      A-T is associated with, among other things, a resistance to insulin, which causes fatty liver~     and diabetes. This study will recruit people who have A-T, but have not developed diabetes,~     and compare this group to healthy controls, i.e. people who do not have A-T or diabetes.~     The study will compare how the groups respond to two drugs used to treat diabetes (metformin~     and pioglitazone), with the intention that this will guide the management of diabetes in A-T.~      This is an, open label unblinded study recruiting 15 people with A-T and 15 age and gender~     matched controls. Each participant will have three study visits to the Clinical Research~     Centre at Ninewells hospital in Dundee - one at baseline, a second after 8 weeks of metformin~     and the final visit after eight weeks of pioglitazone. During each visit we will carry out a~     number of investigations to study the insulin resistance of A-T and how it responds to~     metformin and pioglitazone.~   "
63661|NCT02733666|"~     Lateral humeral condyle fractures are the second most common elbow fractures in children.~     Displaced and rotated fractures require stabilization and reduction. Kirschner wires~     (K-wires) are most commonly used for fracture fixation. Here, the investigators introduce a~     new fixation method involving absorbable screws. The investigators aimed to determine if it~     is feasible to treat lateral humeral condyle fractures with absorbable screws by comparing~     the functional outcomes obtained using screw fixation vs. K-wire fixation.~   "
63662|NCT02733653|"~     The purpose of this study is to evaluate the safety and effectiveness of the Jetstream~     Atherectomy System for the treatment of Japanese patients with symptomatic occlusive~     atherosclerotic lesions in native superficial femoral artery (SFA) and/or proximal popliteal~     arteries (PPA).~   "
63663|NCT02733640|"~     The investigators sought to evaluate the influence of pantoprazole, indicated as less~     effective than other proton pump inhibitors, on the antiplatelet effect of clopidogrel, with~     stratification of the population according to the presence of cytochrome (CYP) 2C19~     polymorphism.~   "
63664|NCT02733627|"~     The primary objective of this trial is to investigate the safety and tolerability of BI~     1467335 in healthy male and female subjects following oral administration of multiple rising~     doses over 28 days.~      Secondary objectives are the exploration of the pharmacokinetics (PK) and target engagement~     biomarkers of BI 1467335 after multiple dosing.~   "
63665|NCT02733614|"~     18-week, crossover, double-blind, randomized, placebo controlled proof-of-concept study to~     assess the efficacy and safety of SRX246 (160 mg bid) vs placebo in 52 adult veterans and~     civilians with a primary diagnosis of PTSD. Subjects will be randomly assigned in a~     double-blind fashion to 2 groups in a crossover design. The first group will receive SRX246~     for 8 weeks followed by 8 weeks of placebo, while the second group will receive placebo for 8~     weeks followed by 8 weeks of SRX246. Both groups will engage in a 7-day washout period~     between treatments. Subjects will be assessed at baseline and then every 2 weeks during the~     trial using the CAPS.~   "
63666|NCT02733601|"~     National, prospective, multicentre, non-interventional epidemiological study, conducted among~     oncologists and breast surgeons in community and university hospitals, from the public sector~     in Algeria.~      The study will collect information on the characteristics, and breast carcinomas patterns of~     patients whose breast cancer diagnosis was confirmed by an anatomopathologist. The study will~     be conducted over a representative, but not exhaustive sample of Algerian female patients.~   "
63667|NCT02733588|"~     The primary objective of this study is to test an optimized control system for sensor-guided~     (physician administered) delivery of glucagon, and test Proof-of-Concept (POC) in a clinical~     setting in patients with severe hypoglycemia following bariatric surgery.~   "
63668|NCT02733575|"~     This study aims to develop and test the feasibility of a new therapy called Compassion~     Focused Therapy (CFT) for psychosis. This therapy helps people with psychosis manage~     distressing experiences by building internal feelings of safeness and affiliation, and by~     providing contexts, practices and insights that facilitate the development of compassion to~     self and others. The focus is on helping people feel safe in relation to their experiences~     and their social worlds. CFT is a promising new approach that has been successfully provided~     for people with a range of mental health difficulties. It is also firmly based in the most~     up-to-date knowledge and science about how the mind works (both normally and under stress).~      9 participants will be recruited from NHS psychological therapies services for people with~     psychosis in South London and Maudsley (SLAM) NHS Foundation Trust. Following a short~     baseline period they will receive up to 26 weekly sessions (about 6 months) of CFT with a~     clinical psychologist, and will provide interview and questionnaire research data at five~     different points during the study. At these assessment points, data will be gathered on~     participants' experiences, mood, perceptions of their position in the social world, and heart~     rate variability.~      The initial therapy protocol has been developed by psychologists with expertise in CFT,~     alongside people with lived experience of hearing voices and having distressing beliefs.~     However, it will continue to be developed and evolve as the study progresses, and as more is~     learnt (e.g. from the service-user participants) about applying the model in this population.~     At the end of this study, the aim is to have all the information needed to run a randomised~     controlled trial of this therapy.~   "
63669|NCT02733562|"~     Sleeve gastrectomy is one of the most common surgical procedures performed today for patients~     that undergo bariatric surgery. One of the primary reasons for morbid obesity is unhealthy~     eating habits and the belief that changes in those habits can ensure the success. Objectives:~     The investigators aimed to explore the effect of different eating habits prior to the~     bariatric surgery on the surgery success and on different aspect of quality of life. Design:~     The investigators conducted this study on patients that underwent sleeve gastrectomy as the~     first bariatric operation.~   "
63670|NCT02733549|"~     Dizziness is one of the most common complaints among patients admitted to the emergency~     department (ED). In most cases, the etiology remains unclear. Dizziness has a broad~     differential diagnosis. The initial symptoms of ALD can include many general complaints. Aim~     of this study is to investigate whether SOD is a symptom of ALD, the necessity of liver~     function tests for patients with SOD in the ED, and a cost analysis of liver function tests.~   "
63671|NCT02733536|"~     The aim was to evaluate the performance of the C-MAC compared with Macintosh when performed~     in patients with immobilized cervical spine by unexperienced physicians.~   "
63672|NCT02733523|"~     Motivations:~      Socio‐economic and education determinants have a big impact on health outcomes, in terms of~     worse health status in populations living in more disadvantaged conditions. Social capital,~     self‐management and health literacy are some of the intermediate determinants, with the~     potential to mitigate health inequalities through interventions driven by local health~     agents. These three determinants are intensely interlinked and have, separately, impacts on~     self‐perceived health. Social capital is defined in this project as an umbrella concept,~     which includes quantitative aspects of social resources (structural social capital: social~     networks and contacts, social and civic participation) as well as qualitative or subjective~     aspects (cognitive social capital: perceived social support, feeling of belonging and trust)~     and covers relations between subjects at a micro or individual level (family and friends) as~     well as at a macro or community level. Health literacy is understood as cognitive and social~     skills which determine the motivation and ability of individuals to gain access to,~     understand and use information in ways which promote and maintain good health. Both are key~     aspects for self‐management behaviours. The target of our research project are older people~     living in urban socioeconomically disadvantaged areas, since ageing is in itself an~     inequality axis and urban environments concentrate the highest health disparities.~      Objectives: With the aim to reduce health inequality, an intervention has been designed to~     promote self‐management, health literacy and social capital among older people who perceived~     their health as fair or poor and are living in urban socioeconomically disadvantaged areas~     with the aim of improving their self‐perceived health. Secondarily, the efficacy of the~     intervention will be analysed in terms of increasing self‐management, health literacy and~     social capital (social support and social participation), quality of life, mental health and~     healthy lifestyles.~      In third place, behavioural health patterns will be identified in relation to health~     literacy, social capital, gender, socioeconomic and educational level, and they will be~     linked to the intervention efficacy levels.~   "
63673|NCT02733510|"~     -  The purpose of this study is evaluating the impact of steroid pulse therapy (SPT) on SCR~          revealed on PB in KT recipients maintained on TAC/MMF and corticosteroid.~        -  In our institution, since routine protocol biopsies are performed at 2 weeks, 1 year,~          and 2 years after renal transplantation, it is practically difficult that graft survival~          is used as an endpoint for randomized controlled trials.~        -  From a meta-analysis for 31 observational studies , acute rejection was associated with~          an increased risk of graft loss risk ratios ranged from 1.2 - 10.5. Furthermore, chronic~          allograft nephropathy and graft survival is strongly correlated with acute rejection~          episode during the first year after renal transplantation.~        -  Therefore, the aim of this study is to investigate the effect of early steroid pulse~          therapy for the reduction of acute rejection episode during the first year after KT in~          the patients who will show subclinical changes at 2-week protocol biopsy.~        -  The histological feature at 1 year PB, graft function (represented by serum creatinine~          level and eGFR) during the 1st year of KT were compared between SCR group and non-SCR~          group.~        -  Additional benefits including early detection of polioma BK virus associated nephritis~          (BKVAN) and relapsed underlying disease are also evaluated.~   "
63674|NCT02733497|"~     Essential palmar hyperhidrosis (EPH) is a pathological condition of excessive sweating of the~     hands due to an unexplained over-activity of the T2 and T3 sympathetic fibers. Endoscopy~     Thoracoscopic Sympathectomy (ETS) is the treatment of choice in patients with EPH refractory~     to medical treatment .~      The cardiac sympathetic activity is mainly controlled by cervical sympathetic fibers but~     anatomic studies have showed that accessory fibers from the T2 and T3 sympathetic ganglia~     come to the heart and influence its function.~      Heart Rate Variability (HRV) is a simple and non-invasive method based on electrocardiogram~     to evaluate the sympathovagal balance at the sino-atrial level. Several studies have found~     that ETS caused a decrease of heart rate (HR), an increase of HR variability (HRV) and a~     shift of sympathovagal balance toward parasympathetic tone but remains unclear if these~     changes are associated with the extend of ETS.~      Thus, in the present study the investigator performed a prospective analysis of HRV function~     in patients with EPH undergoing different sympathetic denervations as sympathectomy and~     sympathicotomy with the hypothesis that cardiac autonomic changes could be associated with~     the extend of sympathetic resection.~   "
63675|NCT02733484|"~     The purpose of this study is to determine whether the probiotics will be effective in the~     treatment of obesity~   "
63680|NCT02733419|"~     This is an open-label, randomized and multi-center study to compare the efficacy and safety~     of continued enfuvirtide (Fuzeon) plus (+) OB therapy versus OB alone in participants with~     HIV-1 infection. Participants will receive an initial 28 week induction treatment with~     enfuvirtide + OB. After 28 weeks participants with a plasma viral load less than or equal to~     (</=) 400 copies/milliliter (mL) at Week 16 and less than (<) 50 copies/mL at Week 24 will be~     randomized in the ratio 1:1 to receive either enfuvirtide + OB or OB alone for another 24~     weeks (up to Week 52).~   "
63681|NCT02733406|"~     Hypotension will often complicate induction of anaesthesia. The investigators want to test~     the hypothesis that Target Controlled Infusion, as opposed to Velocity Controlled Infusion,~     leads to less degree of hypotension.~   "
63682|NCT02733393|"~     The purpose of this pilot study is to evaluate the utility of sphenopalatine ganglion (SPG)~     block to manage ipsilateral shoulder pain (ISP) after thoracotomy. This will be an open label~     preliminary pilot study to determine if SPG block has potential utility to manage ISP in~     post-thoracotomy patients. The primary outcome variable will be reduction of shoulder pain.~   "
63683|NCT02733380|"~     This is a prospective phase II clinical trial to observe the efficacy and safety of Chidamide~     combined with VDDT(vinorelbine，liposomal doxorubicin，dexamethasone and thalidomide) in~     relapsed and refractory patients with diffuse large B-cell lymphoma(DLBCL).~   "
63684|NCT02733367|"~     This is a Phase 3, open-label, single-group, non-randomised, observational study of the~     safety and biochemical disease control of Infacort® in neonates, infants and children with AI~     who have completed study Infacort 003. All subjects who have satisfactorily completed study~     Infacort 003 will be offered the opportunity to take part in Infacort 004.~   "
63685|NCT02733354|"~     Based on real cases, daily life scenarios of peritoneal dialysis and hemodialysis patients~     were shooted and edited into video films, including environment of home dialysis, dietary~     patterns, water intake, sports mode, daily work, short time of travel and other activities,~     covering a certain natural day of either peritoneal or hemodialysis and some important time~     points in the way of life, such as nursing and treatment for common complications of the~     corresponding dialysis mode. The videos will also show the advantages and disadvantages of~     the two modes of dialysis. According to their actual living conditions, patients will decide~     the right dialysis modality that suite them well, thus improving dialysis compliance and~     psychological adaptability.~   "
63686|NCT02733341|"~     Major heart attacks are caused by a number of factors, the two major of which are furring up~     of a coronary artery with atheroma and then sudden clot formation on this area leading to a~     blockage and interruption of blood flow. The clots that lead to heart attacks are largely~     made of clotting blood cells (platelets) that in health repair blood vessels and inhibit~     spontaneous bleeding. One of the main treatment strategies for heart attacks is to make these~     cells less sticky. Aspirin is a main stay of anti-platelet treatment in the United Kingdom~     (UK) and in addition one of three other oral antiplatelet agents acting on the same platelet~     activation pathway (P2Y12 receptor) is licensed for use. When a patient is admitted with a~     major heart attack, they are treated with emergency primary percutaneous coronary~     intervention (PPCI) a technique where a wire and balloon are used to reopen the coronary~     artery and then usually a stent (a slotted metal tube) is placed to keep the artery open.~     Aspirin and one of the P2Y12 inhibitor agents are given to prevent further clots and all have~     been shown to reduce negative events following heart attacks and angioplasty with stent~     insertion. There are increasing data, including from our own institution, showing that in the~     setting of heart attacks, the oral P2Y12 inhibitors are poorly absorbed and have little~     effect at the time of most need, i.e. soon after dosing while the primary PCI is being~     performed.~      All three current P2Y12 inhibitor agents are taken in tablet form immediately before the~     emergency PPCI procedure. It appears that in healthy stable patients these agents take at~     least 30 min to 2 hours to have an adequate effect. In heart attack patients the angioplasty~     procedure is usually performed well within this timescale. Furthermore, patients who are~     having a heart attack do not have normal drug absorption with blood being diverted away from~     the stomach and gut activity being suppressed by other drugs such as morphine.~      In this current study, patients with major heart attacks will be given our standard oral~     agent, Ticagrelor, or the newer intravenous agent Cangrelor prior to PPCI.~   "
63687|NCT02733328|"~     The study aims to recruit 156 (54 Acute Kidney Injury (AKI);102 non-AKI) patients undergoing~     Cardio pulmonary bypass (CPB) surgery, including those with Chronic Kidney Disease (CKD) and~     multiple co-morbidities. Urine and blood samples collected pre-operatively and then 0, 3, 6~     and 18 hours post-CPB will be stored at -80oC until batch analysed for NGAL using the Abbott~     and BioPorto assays. AKI - defined as a ≥50% rise in serum creatinine (SCr) over baseline, or~     the requirement for renal replacement therapy (RRT). SCr will be measured pre-operatively~     (baseline), then 12 hourly for the first 48 hrs post-CPB and thereafter 24 hourly for 5 days.~     Clinical data collected will include patient demographics, co-morbidities, drug history,~     pre-operative renal function, surgery details (type, length, CPB time etc.), length of~     Intensive treatment unit and hospital stay and post-operative complications. Data will then~     be analysed comparing the two NGAL tests to find out which is superior, whether it is better~     to use blood or urine and to define optimal NGAL cut-offs and sample timing for predicting~     AKI. Both the Abbott and BioPorto assays will subject to a laboratory method evaluation prior~     to the analysis of any patient specimens in order to verify that their performance is~     acceptable and meets the manufacturer's claims. This will involve measuring the standard~     parameters used to assess laboratory assay performance e.g. imprecision (reproducibility),~     linearity, recovery and method comparison etc.~   "
63688|NCT02733315|"~     The Diabetes Conversation Map Program (DCMP) is a novel, group-based, interactive diabetes~     management education program that has been shown to help patients adapt to their disease. So~     the investigators aimed to examine the long-term effectiveness of the DCMP among diabetes~     patients in Taiwan.~   "
63689|NCT02733302|"~     The control of diabetes is related both to food, treatment but also to physical activity.~     Despite these recommendations and these positive findings, patients are always sedentary~     because of brakes in the practice of a regular physical activity.~      It is therefore interesting to consider the representations of patients and particularly on~     the way of establishment in order to reach a goal. The Hope Theory highlights the hope as the~     sum of the will and means that an individual has to achieve its goals. Will be discussed in~     this study to identify a relationship between the level of hope for patients and their~     ability to permanently change their behavior in regular physical activity as part of the~     goals set during the week of therapeutic education patient.~   "
63690|NCT02733289|"~     Standard evaluation and follow-up data regarding complications of curative radiation~     treatment for cervical cancer.~   "
64235|NCT02726191|"~     The purpose of this randomized uncontrolled single-site trial is to evaluate the efficacy of~     two novel computerized cognitive enhancing software packages for improving cognitive and~     behavioral outcomes in patients with epilepsy.~   "
63691|NCT02733276|"~     Fatigue is a common symptom in inflammatory bowel diseaseI and persists despite clinical~     remission. Fatigue in patients with chronic diseases can be objectified by the FACIT-F scale.~     Acupuncture has been shown useful in the treatment of fatigue in various chronic diseases.~      This study evaluates the effect of electroacupuncture in the treatment of fatigue in patients~     with quiescent inflammatory bowel disease.~      Patients with inflammatory bowel disease and severe fatigue (FACIT-F score <38) who agree to~     participate in the study will be randomized to three different treatments: electroacupuncture~     vs. sham electroacupuncture vs. control group.~   "
63692|NCT02733263|"~     Resistant maltodextrin (RMD) is an indigestible water soluble fiber that increases fecal bulk~     by enhancing growth of specific microbial populations; however the effect of RMD on~     bifidobacteria and total fecal weight is not clear. The purpose of this research study is to~     determine whether incorporating about ¼ cup of a fiber supplement into the diet will induce~     beneficial changes in gastrointestinal function, the fecal microbiota profile (increased~     number of healthy bacteria in stool) and immune processes resulting in improved quality of~     life.~   "
63693|NCT02733250|"~     The purpose of this study is to determine the optimal dose of nab-paclitaxel to be safely~     administered in combination with pembrolizumab in patients with advanced inoperable non-small~     cell lung cancer. The study is also aimed at evaluating the efficacy of the combination~     therapy.~   "
63694|NCT02733237|"~     To investigate whether intranasal oxytocin (40 IU) treatment can influence the tolerance of~     infidelity in males and females.~   "
63695|NCT02733224|"~     we intend to evaluate the association between non-adherence to Lenalidomide in Multiple~     Myeloma (MM) patients and overall response rates and time to progression (TTP).~      Adherence will be measured in several ways, including by electronic monitoring, which is the~     gold standard method.~   "
63696|NCT02733211|"~     The MD-Logic Automated Insulin Delivery System is intended for patients with type 1 diabetes~     mellitus for subcutaneous infusion of insulin and the continuous measurement of interstitial~     glucose to aid in the management of their diabetes. The product automatically adjusts basal~     insulin delivery and delivers correction boluses in response to real-time glucose~     measurements by CGM to maintain blood glucose within the desired range, to improve metabolic~     control without increasing the risk of hypoglycemia.~      The proposed study is an open-label, two-center, randomized, cross-over study to evaluate the~     safety and efficacy of night closed-loop control using the MD-Logic automated insulin~     delivery system compared to sensor augmented pump therapy in poorly controlled patients with~     type 1 diabetes at home The objective of this pilot study is to evaluate the safety and~     efficacy of 4 weeks glucose control using the MD-Logic System in individuals with poorly~     controlled type 1 diabetes at patient's home~   "
63697|NCT02733198|"~     To evaluate the effect of a prognosis-guided vs standard medical therapy in the: 1) duration~     of hospital stay; 2) cost-effectiveness; 3) satisfaction and quality of life; 4) in-hospital~     and 30-day all-cause mortality; and 5) 30-day readmissions in normotensive patients with~     acute symptomatic pulmonary embolism (PE).~      Design: Prospective, randomized, controlled, single blind trial. Normotensive patients with~     acute symptomatic PE will be randomly assigned to follow a prognosis-guided treatment, or to~     receive usual care.~      Setting: Respiratory, Medicine and Emergency Departments in 15 Spanish hospitals.~      Analyses: Data for the primary and secondary end points will be analyzed according to the~     intention-to -treat principle. The intention-to-treat analysis will include all randomly~     assigned patients. For the efficacy end points, investigators will use the Mann-Whitney U~     test. We will also use competing risk regression models according to Fine and Gray. For the~     safety end points, comparisons will be made with the use of the chi-square test. Separate~     analyses will be done in key prespecified subgroups of patients, according to age and~     hospital size.~   "
63698|NCT02733185|"~     Trial to Assess Chelation Therapy 2 (TACT2) is a randomized, double blind controlled~     factorial clinical trial of edetate disodium-based chelation and high-dose oral vitamins and~     minerals to prevent recurrent cardiac events in diabetic patients with a prior myocardial~     infarction (MI).~   "
63699|NCT02733172|"~     The investigators plan to extensively phenotype a large sample of Vulvodynia (VD) patients~     using functional and structural brain imaging together with genetic, physiological, and~     biological parameters.~   "
63700|NCT02733159|"~     This study is to determine that pembrolizumab is safe and tolerable at the selected dose for~     the treatment of Non-Small Cell Lung Cancer (NSCLC) in patients with a performance status of~     2. All patients will receive pembrolizumab.~   "
63701|NCT02733146|"~     To evaluate the significance of free-plasma deoxyribonucleic acid (DNA) and plasma histones~     in cardiac arrest patients.~   "
63702|NCT02733133|"~     This study will assess the potential of Testagen® TDS-Testosterone to enable transfer of~     Testosterone to females coming in contact with skin to which Testagen® TDS-Testosterone has~     been applied and the potential of product to raise serum androgen levels in those women.~   "
63703|NCT02733120|"~     The objective of this study is to gain preliminary information and knowledge on metabolic~     profile in ASD. The benefit of this study will be to expand our insight of the potential~     relationship in metabolic processes and neuropsychological functions in ASD. For example,~     based on the obtained data of the study we can determine whether there is a link between the~     tryptophan pathway and cognitive functions in autism. The project is based on a systematic~     and multidisciplinary approach using tracers for delineating the mechanism by which the~     metabolism of amino acids like TRP is involved in affective and cognitive functions in ASD.~     Using an innovative approach to the evaluation of amino acids has not been used in adults~     with ASD. In addition, the obtained data of the study holds promise to develop specific~     markers (metabolic and/or neuropsychological) for guiding the identification those~     individuals with increased risk of developing mood disturbances or cognitive impairment, and~     for predicting the therapeutic effect of a specific nutritional interventions in subjects~     with ASD.~   "
63743|NCT02732600|"~     In August 2014, the White House issued an Executive Action mandating that 25 VA medical~     centers place Peer Specialists (Veterans recovered from mental illness who are trained to~     support other Veterans with mental illness) on Primary Care Teams. Research shows that the~     success of adding new staff to existing teams can be improved by outside aid and~     facilitation. This quality improvement project will evaluate whether providing expanded~     support to half of the Primary Care Teams will lead to better outcomes when compared with~     teams that do not get extra support.~   "
63704|NCT02733107|"~     The development of anti-angiogenesis drugs has led to renewed enthusiasm in lung cancer~     treatments. Apatinib is a tyrosine kinase inhibitor which selectively inhibits the vascular~     endothelial growth factor receptor-2 (VEGFR-2). Etoposide is an oral preparation for lung~     cancer which is recommended by NCCN guideline. The investigators wondered whether these two~     drugs have synergistic effects when treating advanced non-small cell lung cancer patients who~     failed to previous at least 2nd line treatments. Thus, the aim of this trial is to~     investigate the efficacy and safety of apatinib combined with etoposide in heavily pretreated~     advanced non-small cell lung cancer.~   "
63705|NCT02733094|"~     The purpose of this study is to explore the efficacy and safety of anti-Interleukin-(IL)17~     therapy (secukinumab, administered weekly for 4 weeks followed by four-weekly administration~     until week 16) for the treatment of pyoderma gangrenosum.~   "
63706|NCT02733081|"~     This is a randomized controlled trial that compares traditional IUD insertion with that of a~     no uterine sound, no bimanual pelvic exam approach. The investigators hypothesis is that IUD~     placement is safe and effective without pre-procedural assessment of uterine size, direction,~     or depth.~   "
63707|NCT02733068|"~     A Phase III Double Blinded, Randomized Controlled Study to Evaluate Efficacy of Protection~     Against HPV-16 and 18 Related Diseases, Immunogenicity and Safety of Recombinant Human~     Papillomavirus Virus-like Particle Vaccine (Type 16 and 18 L1 Proteins, Yeast) in Healthy~     Females Aged 18-30 Years.~   "
63708|NCT02733055|"~     Determine the effects looking in certain direction or moving the eyes in a certain way have~     on the ability of a subject to maintain equilibrium in different circumstances (eyes~     open/closed, and standing on hard or compliant surface, with the head straight or rotated~     right or left, flexed or extended).~   "
63709|NCT02733042|"~     This open-label, multicenter, global study is designed to determine the recommended phase 2~     dose, safety, efficacy, and pharmacokinetics/pharmacodynamics of durvalumab in subjects with~     certain lymphoma subtypes or CLL. Globally, 265 subjects may be enrolled into 4 treatment~     arms, including durvalumab monotherapy; durvalumab in combination with lenalidomide±~     rituximab; ibrutinib; or rituximab ± bendamustine. The study will have 3 parts: dose finding,~     dose confirmation, and dose expansion. Subjects receiving monotherapy may receive combination~     therapy or involved-field radiation to a single nodal site at time of progressive disease.~   "
63710|NCT02733029|"~     The purpose of this study is to determine the feasibility and efficacy of detecting kidney~     transplant rejection using contrast enhance ultrasonography with the contrast agent Sonazoid.~   "
63711|NCT02733016|"~     Seinäjoki Adult Asthma Study is a single-centre 12-year follow-up study of a total cohort of~     259 patients having new-onset asthma that was diagnosed at adult age. The study was divided~     in two parts: the collection of the original cohort (phase I;n=259) and follow-up visit~     (phase II; n=203). The aim of this study is to increase the understanding on the diagnostics~     and diagnostic process, organisation of the long-term asthma care, therapeutic outcomes,~     prognosis and the factors affecting the prognosis of new-onset asthma diagnosed at adult age.~   "
63712|NCT02733003|"~     This study seeks to implement the Women's Health CoOp (Cooperative) (WHC) intervention into~     HIV treatment centers (HCT), antenatal, and substance treatment clinics in South Africa to~     translate the evidence-based intervention into real-world settings. Implementation, service,~     and patient outcomes will be evaluated through an iterative stepped wedge design.~   "
63713|NCT02732990|"~     Exercise intolerance is a major limiting symptom in patients with CHF. However the poor~     correlation between the hemodynamic parameters of left ventricular performance at rest and~     exercise performance has led to the concept that peripheral factors such as muscle perfusion~     and muscle metabolism play a role as determinants of exercise capacity.~   "
63714|NCT02732977|"~     Heart failure is a growing throughout pathology in Europe. It is a public health issue and an~     economic issue. The management to be effective needs to be early but specific. Generic~     treatment (medication, rehabilitation, hygienic dietary measures) known for over 15 years and~     has demonstrated its effectiveness, come s'ajouter solutions specific, technically complex~     and expensive to implement. Because of the potential risk to the patient and their cost to~     the company, these new techniques need to be adapted to each case. The passage of a generic~     simple treatment for everyone in the single treatment tailored to each patient requires~     decision support tools for the clinician. These tools or decision trees are developed using~     mathematical and statistical models fed by all patient data (imaging, biology physiology ...)~     before and after implementation of treatment. Predictive response models of a treatment~     applied to a particular pathology can thus be generated.~      It is this type of models applied in systolic heart failure complicated by mitral~     regurgitation and / or cardiac synchronization that will be generated in this project from~     150 patients included in 3 European clinical studies (London, Brussels, Caen). In Caen we~     will include 30 patients in this single-center study~   "
63715|NCT02732964|"~     The aim of this study is to evaluate the effect of perioperative music on maternal anxiety,~     hemodynamic response to spinal anesthesia, postoperative pain medication requirement, and~     overall maternal satisfaction.~      Investigators hypothesize that women exposed to perioperative music will have greater overall~     satisfaction with the delivery experience. Investigators also hypothesize that perioperative~     music will lower anxiety levels of women having a scheduled cesarean delivery, result in a~     less profound degree of spinal-induced hypotension prior to cesarean delivery, and result in~     a lower requirement of analgesics postpartum.~   "
63716|NCT02732951|"~     This is a proof of mechanism trial to explore the effect of BI 1026706 on the central retinal~     thickness and to evaluate safety and tolerability of BI 1026706 administered orally for 12~     weeks in patients with mild vision impairment due to center-involved DME~   "
63717|NCT02732938|"~     The purpose of this Phase 1b/2 study is to evaluate the safety and tolerability of~     PF-04136309 in combination with nab-paclitaxel and gemcitabine, characterize the~     dose-limiting toxicities (DLTs) and overall safety profile of escalated doses of PF-04136309~     and the associated schedule, determine the maximum tolerated dose (MTD), and to assess the~     enhancement of efficacy of PF-04136309 in combination with nab-paclitaxel and gemcitabine~     versus nab-paclitaxel + gemcitabine + placebo in terms of Progression Free Survival.~   "
64250|NCT02725983|"~     Evaluate the effects of using an intra-oral camera (IOC) during supportive periodontal~     therapy (SPT), on the psychological, behavioral and clinical parameters of patients with~     gingivitis, outlined by evidence and a theory-based framework.~   "
63718|NCT02732925|"~     The purpose of this study is to determine whether surgical treatment, balloon kyphoplasty is~     more effective compared to conservative treatment alone (sham procedure) when assessing~     clinical, translational, radiological & patient outcomes in patients with multiple myeloma.~      Subjects will be recruited to the study if they have VAS score ≥ 6 and has given informed~     consent to participate in the Melody Study will be randomised to Arm 1 Sham Procedure and~     Conservative treatment or Arm 2 Balloon Kyphoplasty and Conservative treatment. Subjects~     recruited to Arm 1 (Sham Procedure and Conservative treatment) can cross over into Arm 2~     (Balloon Kyphoplasty and Conservative Treatment) if they have a VAS score ≥ 6 between 8-12~     weeks.~   "
63719|NCT02732912|"~     The aim of this study is to determine whether routinely providing patients admitted to~     hospital with two devices to help sleep - ear plugs, and an eyeshade - leads to patients~     having a better quality of sleep and/or longer, more satisfying sleep.~   "
63720|NCT02732899|"~     To determine safety and efficacy of intravitreal injections of Sirolimus with adjunct EYLEA~     in subjects with exudative age related macular degeneration (AMD) with persistent~     intraretinal or subretinal edema due to neovascular AMD despite previous intravitreal~     anti-vascular endothelial growth factor (antiVEGF) treatment.~   "
63721|NCT02732886|"~     This study is to compare the efficacy and safety of Medifoam® and Betafoam®, which is a new~     dressing that contains povidone-iodine, in patients with diabetes foot ulcer. 70 patients (35~     each arm) are targeted to be enrolled in this study. Treatment follow periods are 8weeks.~   "
63722|NCT02732873|"~     The REKREATE project will be an international, multi-centre, non-randomised, prospective~     single-arm pivotal study. All study patients will receive the FibroFix™ Meniscus scaffold~     following the provision of informed consent. A study period of 1 year and extended follow up~     period of up to 3 years is planned , to enable a thorough and complete assessment of the~     performance of the device when implanted to replace removed or damaged meniscal tissue in~     humans. The test article for this multi-centre study is the FibroFix™ Meniscus scaffold,~     which has been developed for repair of defects of the meniscus.~   "
63723|NCT02732860|"~     By obtaining clinical specimens from participants with triple negative breast cancer (TNBC),~     colorectal cancer (CRC), high grade serous ovarian cancer (HGSOC), and other select tumor~     types to establish and profile as freshly implanted tumors in mice, the aim of this study is~     to identify agents with predicted activity in the host patient while also potentially~     providing them with personalized cancer treatment options~   "
63724|NCT02732847|"~     Delayed prescriptions have been shown to lower antibiotic use for upper respiratory tract~     infections (which are mostly viral).~      This trial will test the hypothesis that if the clinician post-dates the delayed prescription~     by 2 days, rather than dating it on the day the patient is seen, there will be a further drop~     in the rate of antibiotic use.~   "
63725|NCT02732834|"~     The purpose of this study is to better understand communication between patients with lung~     cancer and their clinicians. The investigators are also interested in patient's perceptions~     of the quality of communication with his/her clinician and how these perceptions may impact~     patient outcomes. The clinician participating in this study and has given us permission to~     approach his/her eligible patients for study participation.~   "
63726|NCT02732821|"~     This study is performed to assess the efficacy and outcomes of Gastric Per Oral Endoscopic~     Myotomy G-POEM in patients presenting with gastroparesis.~   "
63727|NCT02732808|"~     This study is a prospective before & after clinical trial to investigate the efficacy of~     double stimulations during both the follicular and luteal phases in patients with poor~     ovarian response undergoing IVF and intracytoplasmic sperm injection (ICSI) cycles.~      The study protocol is approved by the Ethics Committee (Institutional Review Board) of Royan~     institute. The study is conducted according to the Declaration of Helsinki for medical~     research. All participants provide informed consent after counseling for infertility~     treatments and routine IVF/ICSI programs.~      All the patients who diagnosed as poor ovarian responders (POR) based on the Bologna criteria~     are eligible for participation in this study. In order to define the poor response in IVF, at~     least two of the following three features must be present: (i) advanced maternal age or any~     other risk factor for POR; (ii) a previous POR; and (iii) an abnormal ovarian reserve test~     (ORT). Two episodes of POR after maximal stimulation are sufficient to define a patient as~     poor responder in the absence of advanced maternal age or abnormal ORT.~      Stage one of treatment protocol First stimulation performs by Clomiphene citrate (Ovumid®,~     Iran Hormones Company) 25 mg/day with co-treatment of Letrozole (Letrofem®, Iran Hormones~     Company) 2.5 mg/day are given from cycle day 3 onwards. Letrozole is only given for 4 days~     and clomiphene citrate is continuously used before the trigger day. Patients start to inject~     human menopausal gonadotrophin (HMG) (Menopur®, Ferring, Switzerland) 150 IU every other day~     beginning on cycle day 6. When one or two dominant follicles (18 mm in diameter) observed,~     the final stage of oocyte maturation will be induced with triptorelin 100 μg (Decapeptyl®;~     Ferring GmbH, Germany) follows by ibuprofen 600 mg (Ibuprofen-Najo® , Coated Tablets, Najo~     Company, Iran) is used on the day of oocyte maturation triggering and the day after. After~     the first oocyte retrieval, human menopausal gonadotrophin and letrozole are administrated to~     stimulate follicle development, and oocyte retrieval will be carried out a second time when~     dominant follicles have matured. All highest-quality embryos (including grade 1 and grade 2,~     eight-cell blastomere embryos) will be cryopreserved by vitrification method on the third day~     after oocyte retrieval.~      Stage two of treatment protocol:~      Transvaginal ultrasound evaluation performs after oocyte retrieval to determine whether to~     continue the second ovarian stimulation. The criterion for continued stimulation is the~     presence of at least two antral follicles 2-8 mm in diameter. A total of 225 IU HMG~     (Menopur®, Ferring, Switzerland) and letrozole 2.5 mg (Letrofem®, Iran Hormones Company) is~     administered daily from the day of, or the day after, oocyte retrieval. The initial second~     stage follicular monitoring is conducted 5-7 days later, and then for follow up every 2-4~     days, by using a transvaginal ultrasound evaluation, to record the number of developing~     follicles. Letrozole administration is discontinued when the dominant follicles reached~     diameters of 12 mm, given that large follicles have redundant LH and FSH receptors, and good~     response to exogenous hormone stimulations. Daily administration of medroxyprogesterone~     acetate 10 mg (Progestrone®, 5mg bid; Aboureihan, Iran) is added beginning on stimulation day~     12 for cases in which post-ovulation follicle size is smaller than 14 mm in diameter and~     stimulation needed to continue for several more days. This performs to postpone menstruation~     and avoid oocyte retrieval during menstruation, to prevent the risk of infection from the~     procedure. When three dominant follicles reached diameters of 18 mm or one mature dominant~     follicle exceeded 20 mm, the final stage of oocyte maturation is induced again with~     triptorelin 100 μg (Decapeptyl®; Ferring GmbH, Germany) by injection. Again, ibuprofen 600 mg~     (Ibuprofen-Najo® , Coated Tablets, Najo Company, Iran) is used on the day of oocyte~     maturation triggering and the day after. Transvaginal ultrasound-guided oocyte retrieval was~     conducted 32-36 h after GnRH agonist administration. All retrieved oocytes were treated same~     as in the study stage one.~   "
63728|NCT02732795|"~     Adenotonsillectomy (AT) is one of the most common pediatric surgeries performed, and is~     estimated to comprise 530,000 procedures in children under 15 years of age. Historically, the~     leading cause for these procedures was recurrent infections; however, more recently surgical~     indications include sleep disordered breathing and obstructive sleep apnea (OSA).~     Pre-operative polysomnography (PSG) is recommended for all children with suspected OSA prior~     to undergoing AT, although it is unclear whether sleep disordered breathing characteristics~     predict post-operative outcomes or complications.~      Obesity has become an epidemic in our pediatric population. More recently, an increased~     population of obese children are presenting for AT with upper airway obstruction with or~     without tonsillar hypertrophy, which is similar to the adult etiology of OSA. Obesity is a~     multisystem disease, causing fatty liver and cardiac disease, defects in glucose metabolism,~     insulin resistance, leptin resistance, and creates a state of chronic inflammation. Markers~     for inflammation, including TNF-α, CRP, leptin, IL-6 and IL-10, are abnormal in obese~     patients and have also been linked to more severe OSA disease in children even after~     controlling for BMI.~      In pediatrics, medication dosing is based on an actual body-weight calculation, however,~     recent reports suggest that this dosing method is over-dosing patients with obesity.~     Therefore, increased respiratory complications after surgery may be related to inappropriate~     intra-operative opioid dosing.~      Specific Aim 1 (SA1): To compare analgesic-guided opioid dosing using actual body weight~     (ABW) based dosing versus ideal body weight (IBW) dosing for adenotonsillectomy in children~     with OSA (BMI >/=75%).~      The investigators hypothesize that 1) weight-based opioid dosing compared to dosing based on~     ideal body weight leads to increased respiratory complications defined by (a) upper airway~     obstruction, (b) hypoventilation, and (c) oxygen desaturation without affecting pain scores~     immediately after adenotonsillectomy. In addition, the investigators believe 2) that there~     will be little statistically significant difference in pain scores between ABW and IBW for~     these patients.~      Specific Aim 2 (SA2): To determine whether biomarkers related to obesity, chronic~     inflammation, and OSA predict post-operative respiratory compromise after AT. The~     investigators hypothesize that inflammatory and obesity-related biomarkers are elevated in~     overweight children with OSA, more so in obese children with OSA, compared to lean children~     with OSA.~   "
63729|NCT02732782|"~     This is a prospective single blinded randomised controlled trial with a 12-week intervention~     period and a half-year follow-up period. The main purpose is to determine the effects of~     isometric exercise on mechanical, morphological and functional tendon properties versus~     eccentric exercise in chronic Achilles tendinopathy.~   "
63730|NCT02732769|"~     the Mask fixation isn't a new solution for the immobilization of the patient's head and has~     been used in current practice for long years.~      This trial is attempting to compare these two technical possibilities of head fixation by~     mask or by stereotaxic frame. The primary goal is to evaluate the comfort for the patient and~     specifically for each step of the procedure. It will also evaluate other parameters such as~     the effectiveness of these two strategies and tolerance.The expected benefit is an~     improvement of the comfort for the patients.~   "
63731|NCT02732756|"~     Adolescents with attention-deficit/hyperactivity disorder (ADHD) obtain less sleep than their~     typically developing peers. Observational studies indicate that inadequate sleep is~     correlated with impairment in adolescents with ADHD, but it remains unknown if sleep is~     causally related to impairment. This study will use an experimental sleep restriction and~     extension protocol to evaluate sleep as a contributor to clinically significant impairment~     and possible target for intervention in adolescents with ADHD.~   "
63732|NCT02732743|"~     The primary objective is to assess the efficacy and safety of the Food Supplement~     Physiomanna® Baby in pediatric patients with a history of functional constipation~      The secondary objective of the trial is to evaluate the adherence to product's administration~     in the enrolled children.~   "
63734|NCT02732717|"~     Recent years, women with infertility have become more and more and thus assisted reproductive~     technology has been applied in a broad range. And the quantities of twin pregnancies are~     larger and larger. However, complicated twin pregnancy subsequently increased including~     selective intrauterine growth restriction (sIUGR), twin growth discordance, twin transfusion~     syndrome (TTTS) and intrauterine fetal death (IUFD). The occurrence of complicated twin~     pregnancy has been the leading cause of morbidity and mortality in twin and mother.~     Meanwhile, twin pregnancy, especially monochorionic type has suffered from higher rate of~     chromosomal anomalies and structural anomalies. Therefore, it is important that more~     attention should be paid to the prediction, clinical evaluation and the occurrence of~     chromosomal anomalies and structural anomalies in complicated twin pregnancy.~      So far, prenatal ultrasound has been acknowledged as the best method for prenatal diagnosis~     and evaluation in twin pregnancy. By means of the application of prenatal ultrasound, the~     detection of fetal chromosome, and secondary correlation analysis, the investigators try to~     build prenatal ultrasound monitoring system of twin pregnancy and provide evidences for the~     choice of intervention and delivery time, in order to decrease the morbidity and mortality of~     twin and improve perinatal short and long outcomes.~      The goals of this study are as below: (1) primary goal: the prediction of complicated twin~     pregnancy by using prenatal ultrasound; (2) primary goal: the clinical evaluation of~     perinatal outcomes in twin pregnancy by using prenatal ultrasound; (3) secondary goal: the~     analysis of the correlation between prenatal ultrasound and fetal anomalies.~   "
63735|NCT02732704|"~     The purpose of this research study is to collect information about a new treatment for severe~     aortic regurgitation, which affects the aortic valve in the heart. Aortic regurgitation is a~     condition where the heart's aortic valve does not close tightly and allows some blood to leak~     back into the heart chamber. Symptoms of aortic regurgitation may include fatigue and~     shortness of breath. The preferred treatment for severe aortic regurgitation is aortic valve~     replacement surgery.~   "
63736|NCT02732691|"~     The purpose of this research study is to collect information about a new treatment for severe~     aortic stenosis, which affects the aortic valve in the heart. Aortic stenosis is a narrowing~     of the aortic valve opening, which decreases blood flow from the heart and causes symptoms~     such as chest pain, fainting and shortness of breath. The preferred treatment for severe~     aortic stenosis is aortic valve replacement surgery.~   "
63737|NCT02732678|"~     Adrenergic processes stimulated by epinephrine and norepinephrine drive to the development of~     tumor growth and metastasis. Beta-adrenergic receptor (BAR) antagonists have shown efficacy~     against melanoma, breast cancer and prostate cancer. The non-specific BAR inhibitor~     propranolol has been used as the gold standard treatment in pediatric patients with benign~     infantile hemangioma which express high levels of beta adrenergic receptors potentially~     explaining their sensitively to propranolol. BAR have been shown to be expressed across a~     diverse panel of vascular tumors, with the highest expression in malignant vascular tumors~     including angiosarcoma. Several reports indicate positive results from beta-blockade in~     patients with moderately threatening vascular tumors. It remains to be determined if more~     malignant vascular tumor such as the angiosarcomas are susceptible to propranolol. Besides,~     due to the lack of adequate therapies for angiosarcoma (doxorubicin or paclitaxel and finally~     cyclophosphamide in third line) and to the poor prognosis of this rare and aggressive tumor,~     there is a strong need for the development of treatments against this tumor type. Recently~     using a panel of angiosarcoma cell lines. demonstrate that beta-adrenergic inhibition blocks~     cell proliferation and induces apoptosis in a dose dependent manner. Moreover, using in vivo~     tumor models they demonstrate that propanolol shows remarkable efficacy in reducing the~     growth of angiosarcoma tumors. Based on these proofs of mechanisms in vitro and in vivo and~     due to the well established safety propranolol in humans, investigators propose to determine~     among a wide range of propranolol dose (80 mg/d ; 120 mg/d and 160 mg/d) the optimal one~     based on bivariate efficacy-toxicity outcome in patients with angiosarcoma treated by~     cyclophosphamide. Because these two drugs have different pharmacological mechanisms, the aim~     is to determine the optimal dose of propranolol having the best systemic cardiovascular~     tolerability and the best potential antiangiogenic effect in addition with cyclophosphamide.~   "
63738|NCT02732665|"~     In this study, glycosaminoglycan (GAG) profiling in subjects first diagnosed with metastatic~     ccRCC is hypothesized to be useful in monitoring drug response and predict the outcome of a~     CT scan. To this end, regularly measured plasmatic and urinary GAGs in prospectively enrolled~     subjects will be correlated to drug response as evaluated by the designated clinician based~     on CT scans. A positive correlation indicates that this test can successfully detect patients~     that are not responding to treatment before the scheduled follow-up in which CT scans are~     performed. Data on the extent of metastasis (number of metastatic sites) will be collected to~     assess whether the biomarker level correlates accordingly.~   "
63739|NCT02732652|"~     In this study, a score based on glycosaminoglycan (GAG) profiling in subjects with suspicion~     of renal cell carcinoma (RCC) is hypothesized to distinguish malignant masses when early~     actionable clinical decisions are desirable. For example to screen population at risk or to~     distinguish benign masses from RCC before patient is referred to surgery. To this end, the~     plasmatic and urinary GAGs will be measured in prospectively enrolled subjects and the~     resulting scores correlated to the post-surgical definitive diagnosis and eventual RCC size.~     A positive significant correlation is suggestive that GAG profiling can be used to guide~     clinical intervention in a subject at risk or referred to nephrectomy because of suspicion of~     RCC. The biomarker in patients with high risk RCC will be monitored to observe its~     correlation with disease progression. Also, the biological significance of this positive~     correlation will be evaluated using gene expression profiling. This data may also be used to~     improve further the diagnostic accuracy of the proposed biomarker.~   "
63740|NCT02732639|"~     This study evaluated the efficacy and safety of 48-week treatment with pegylated interferon~     (PEG-IFN) alfa-2a (Pegasys) monotherapy in participants with chronic hepatitis D (CHD).~     Treatment was followed by 24 weeks of treatment-free follow-up.~   "
63741|NCT02732626|"~     This study evaluates if the exclusion of left atrial low voltage areas / scars by ablation~     lines in addition to pulmonary vein isolation may improve the outcome in patients with~     persistent atrial fibrillation in comparison to stand alone pulmonary vein isolation.~   "
63742|NCT02732613|"~     The size selection of Laryngeal Mask Airway classic is usually followed the manufacturer's~     recommendation based on the patient's ideal weight. But sometimes the patient is tall and~     slim, the actual weight is much less than the ideal weight. This phenomenon might affect the~     success rate of insertion. Previous studies had demonstrated that the selection of Laryngeal~     Mask Airway size based on ideal weight could improve the success rate of insertion;~     therefore, this study was designed to prove whether this conclusion also applies to the tall~     and thin patients.~   "
66874|NCT02691624|"~     Lymphoscintigraphy is a noninvasive，accurate and effective imaging modality. In this study,~     it is used to investigate the imaging characteristics of patients'upper limb lymphatic~     drainage before operation, and the influence of operation on it.~   "
63744|NCT02732587|"~     The purpose of this alcohol-interaction pilot study is to provide information on the effect~     of AZD0530 (Saracatinib) on the pharmacokinetics of alcohol and on alcohol responses,~     including stimulation, sedation, intoxication, body sway and physiological responses. The~     investigators propose to test the effects of a single dose of AZD0530 (125 mg) on alcohol~     related responses. This is a within subjects open label study in which the investigators plan~     to run 8 subjects to obtain 5 completers.~   "
63745|NCT02732574|"~     Respiratory dysfunction following cardiac surgery is well documented and due in part to the~     location of the incision and nature of the surgery. Post-operative pulmonary complications~     (PPCs) remain a significant problem following cardiac surgery, sometimes causing prolonged~     length of stay in hospital as well as increased morbidity and mortality; with the greater~     risk to older adults and individuals with obstructive lung disease. Positive expiratory~     pressure (PEP) therapy is thought to increase lung volumes and facilitate secretion~     clearance. The purpose of this study is to investigate whether the addition of oscillating~     PEP therapy to standard postoperative treatment is more effective in decreasing the incidence~     of PPCs and increasing functional capacity at time of discharge in 'high risk' patients~     undergoing elective cardiac surgery.~   "
63746|NCT02732561|"~     This is a trial of the use of cranial electrostimulating therapy for depression and anxiety~     among homeless adults.~   "
63747|NCT02732548|"~     This study is being conducted to collect data on the performance of Miromatrix Wound Matrix~     (MIRODERM) when used in the treatment of complex wounds in an inpatient setting.~   "
63748|NCT02732535|"~     This study will determine the role of the NK cells before and after bariatric surgery. The~     investigators selected patients with NAFLD.~      A Fibroscan evaluation will be assessed as a new modality to evaluate liver fibrosis.~   "
63749|NCT02732522|"~     To analyze whether there is a statistically significant difference in the modifications~     present in the uterine cervix 6 hours after administration of misoprostol 50 µg through~     vaginal versus sublingual routes.~   "
63750|NCT02732509|"~     The purpose of this study is to determine how chronic inflammation influences skeletal muscle~     protein metabolism and metabolic function in humans. The investigators will evaluate acute~     responsiveness to a single bout of exercise in men and women who are either lean or~     overweight/obese. The investigators will explore the relationship between circulating~     inflammatory markers and anabolic, proteomic, and transcriptional responses to acute~     exercise. The investigators will measure skeletal muscle protein synthesis in the~     postabsorptive state and in response to a single bout of exercise.~   "
63751|NCT02732496|"~     The investigators will conduct a randomized placebo-controlled trial of a computerized~     intervention targeting working memory in 30 children with comorbid~     Attention-Deficit/Hyperactivity Disorder (ADHD) and Tourette Syndrome (TS).~   "
63752|NCT02732483|"~     Gastrointestinal(GI) hemorrhage related with gastric cancer is prevalent in advanced cases~     mostly. As endoscopic hemostatic methods such as argon plasma ablation (APC) had developed,~     controlling GI hemorrhage in gastric cancer is much easier these days. but re-bleeding rate~     is still high, even after successful hemostasis with APC or electrical coagulation.~     Furthermore patients who were experienced re-bleeding are expected poorer survival outcomes~     than those who are not. So excellent bleeding control in gastric cancer is most important in~     GI hemorrhage of gastric cancer.~      Recently developed hemostatic powder [Endo-Clot(TM)] is easy to use and have proven its~     usefulness in GI hemorrhage in peptic ulcer diseases. So in this study, investigator will try~     to find out feasibility & safety of Endo-Clot(TM) in GI hemorrhage in gastric cancer.~   "
63753|NCT02732470|"~     Systemic Lupus Erythematosus (SLE) is chronic and systemic autoimmune disease that mainly~     affecting women and leading to organ damages especially skin, joints, kidneys, central~     nervous system and heart. In SLE, immune system dysfunction leads to autoantibodies,~     autoreactive T cells and pro-inflammatory cytokines production. These elements will initiate~     and maintain organ damages. Patients with SLE have disease flares followed by period of~     remission. Flares can occur because of stress, infections, surgery, pregnancy or ultraviolet~     exposition. Furthermore the chronic nature of SLE is an important factor of depression in~     these patients.~      Qi Gong is an ancient Chinese practice based on relaxation movements, posture and breathing~     in order to harmonize the body and mind. This practice improves the general state by reducing~     fatigue and improving sleep. The beneficial effect of Qi Gong in medicine has been studied in~     several diseases including cancer, diabetes, arterial hypertension and fibromyalgia. Qi Gong~     seems interesting in depressed patients but also to reduce stress in healthy subjects.~      The aim of this study is to evaluate the effects of Qi Gong on quality if life in patients~     with SLE. Patients will have two lessons of 60 minutes per week for three months and a~     collective lesson of 90 minutes per week for three months. The teacher of Qi-Gong will~     evaluate adherence to the practice of Qi Gong every week. Clinical and biological data will~     be collected at baseline and at 2th, 4th, 6th, 9th and 12th month. Different evaluation~     scores and neurotrophin levels will be collected at baseline and at 6th month.~   "
63754|NCT02732457|"~     The purpose of this study is to assess the impact of allogeneic hematopoietic stem cell~     transplantations (HSCT) in HIV infected patients on the persistence of HIV and the HIV immune~     response.~   "
63766|NCT02732301|"~     The purpose of this study is to investigate the frequency and grade of gastrointestinal~     dysfunction in patients after thoracic cardiovascular surgery, and to search for biomarkers~     of gastrointestinal dysfunction. All adult patients undergoing elective cardiac surgery~     requiring cardiopulmonary bypass at Örebro University Hospital, Örebro, Sweden, are asked for~     participation in this study. All participating patients sign informed consent at the~     inclusion. The first three postoperative days the function of the gastrointestinal tract is~     scored according to a rating scale (grade 0-4), along with other clinical parameters. Plasma~     blood samples are collected from each patient preoperatively and the first three~     postoperative days. The plasma samples are stored in a biobank for later determination of~     plasma proteins. In the analysis, the patients are divided according to the gastrointestinal~     rating scale and the plasma protein expression, gastrointestinal complications and all-cause~     mortality are compared between the groups.~   "
64251|NCT02725970|"~     The Dietary Guidelines for Americans provide recommendations for making better food and~     physical activity choices that promote health and help prevent disease. Yet, few Americans~     meet the Dietary Guidelines for Americans (DGA) and a large percentage are overweight.~   "
63755|NCT02732444|"~     Chronic Obstructive Pulmonary Disease (COPD) patients in Long-Term Home Oxygen Therapy (LTOT)~     have a reduction in airflow that is not totally reversible. This obstruction may be~     associated with an abnormal inflammatory response of the lungs as a result of inhalation of~     toxic particles, particularly to cigarette smoke. Furthermore, COPD patients also present~     limited symptoms to physical exercise, significant extrapulmonary effects, including weight~     loss, nutritional abnormalities and skeletal muscle dysfunction. Hyperinflation has been~     identified as a major cause of dyspnea and is currently believed to be already present in the~     early stages of the disease, causing limitations in physical capacity. The progressive~     exertional dyspnea is most associated with impairment to activities of daily living,~     decreased quality of life and worse prognosis. Traditionally, the severity of COPD is defined~     by the degree of obstruction, as measured by forced expiratory volume in one second (FEV1)~     after bronchodilator use (post-BD) and can be classified as mild, moderate, moderately severe~     and very severe disease. In the group of patients with Advanced Pulmonary Disease (APD),~     those with partial pressure values of oxygen (PaO2) lower or equal to 55mmHg, or arterial~     oxygen saturation (SaO2) lower or equal to 88% in ambient air; or those with PaO2 values~     between 55-60 or SaO2 lower than 90%, with evidence of pulmonary hypertension or polycythemia~     require LTOT, over 15 hours / day, with evidence of increased survival. The aim of this study~     is to evaluate the erythrocyte membranes stability in COPD and APD patients in LTOT compared~     to healthy subjects. It is a cross-sectional, observational study with evaluation of~     erythrocyte membranes stability among the groups as well as lung function, physical testing,~     laboratory analysis, oxidative stress and quality of life questionnaires. As red blood cells~     are the cells responsible for the gas exchange in the lungs and peripheral tissues, and since~     the patients with COPD and APD have gas exchange impairment compared to the healthy group, it~     is expected to find a difference in erythrocyte membranes stability and levels of oxidative~     stress among the groups.~   "
63756|NCT02732431|"~     Obstructive sleep apnea (OSA) is a common condition of Down syndrome patients. In pediatric~     practice, there is no way to determine the children with an increased risk. The aim of the~     study is to determine the reliability of four questionnaires used in pediatric patients in~     screening of OSA in Down syndrome children.~      Prospective study where patients are evaluated on airway diseases and aeroallergens~     sensitization with 2 parental surveys (PSQ-SRBD and CSHQ), otolaryngologic problems by~     completing by the ENT surgeon 2 others surveys (CAS-15 and SCR), and sleep disease with an~     overnight polysomnography (PSG), in University Hospital in Nice.~   "
63757|NCT02732418|"~     This is a randomized, partially-blinded, multi-center, parallel-group study to evaluate and~     compare the PD and PK of MPA after a single SC injection of either 45 mg/0.3 mL, 75 mg/0.5 mL~     or 105 mg/0.7 mL of Depo-Provera CI, and one cycle of Depo-subQ 104 use when injected in the~     abdomen, in women of reproductive age with confirmed ovulatory baseline cycle~   "
63758|NCT02732405|"~     To assess efficacy (SVR rate) of MK5172 / MK8742 for 12 weeks without RBV in G1b patients~     with compensated cirrhosis (Child-Pugh A5 to A6) previously failing first gen. PI or non~     responders to PR.~   "
63759|NCT02732392|"~     The diagnosis of a ganglionic infringement(achievement) at a patient reached (affected) by a~     prostate cancer is a factor(mailman) of bad forecast. The locoregional ganglionic staging is~     a very important element in the coverage (care). He allows to determine the local extension~     of the disease and the type(chap) of therapeutics to implement(operate) after the surgery.~     The standard cleaning out at present recommended by the European company (society) of urology~     at the patients at intermediate or high risk of second offense (recurrence) after local~     treatment(processing), has to concern the obturating pit, the internal and external iliac~     territories. However this type(chap) of cleaning out does not seem to solve all the problems~     of locoregional stratification. Indeed, several studies concerning the radio-controlled~     cleaning out highlighted that 10 in 30% of ganglions.~   "
63760|NCT02732379|"~     The aim of this study is to evaluate the effect of the aromatherapy with lavender, rose or~     ginger essential oils on nausea, vomiting and postoperative quality of recovery scores in~     patients with postoperative nausea and vomiting.~   "
63761|NCT02732366|"~     The purpose of this study is to test the feasibility and preliminary efficacy of a~     group-based fall prevention program for older adults.~   "
63762|NCT02732353|"~     To measure the absorption kinetics and postprandial amino acid availability after ingestion~     of minced beef compared with hydrolyzed beef in young males. Moreover, the basal muscle~     protein synthesis and the postprandial muscle protein synthetic response to minced beef and~     hydrolyzed beef ingestion are measured in young males. The postprandial muscle protein~     synthetic response is measured and compared during the early postprandial period (0-3 hours)~     after ingestion of the two meat products.~   "
63763|NCT02732340|"~     The purpose of this study is to evaluate triple-branched stent placement in the treatment of~     acute DeBakey I aortic dissection . The investigators design a prospective, single-center,~     open-label, non-controlled clinical trial.~   "
63764|NCT02732327|"~     This study will evaluate the effect, safety, and tolerability of ceftazidime-avibactam~     (CAZ-AVI) plus vancomycin or linezolid compared to standard of care plus vancomycin or~     linezolid as empiric therapy in febrile neutropenic adults with cancer~   "
63765|NCT02732314|"~     This is a 13 week randomized, double blind, parallel group, in home use study among~     approximately 60 male and female subjects, ages 12 to 65 years old inclusive, with atopic~     dermatitis (AD) SCORAD >16. Treatment group assignments will be balanced by disease severity,~     age, and body location of AD lesions. The study will consist of a 1 week washout phase and 12~     week treatment phase. During the washout phase, subjects will be provided with a bar soap for~     bathing and showering and must refrain from using any other products on their body (excluding~     the face) including topical corticosteroids, ointments, lotions, sunscreens, etc. During the~     treatment phase, subjects will be randomized to 1 of 4 test legs. Throughout the treatment~     phase, the subjects will be required to use only the provided bar soap for bathing and~     showering and will apply their test product twice per day, once in the morning and once in~     the evening. No additional creams, moisturizers, lotions or cleansers other than those~     provided will be permitted for the duration of the study. Normal facial or hair care products~     are permitted, however, they must not contain anti-bacterial ingredients (e.g. antidandruff~     shampoo, acne products, etc).~      SCORAD, EASI and PGA will incorporate whole body assessments. However, at the Baseline visit,~     subjects will have an active inflammatory lesion site and adjacent non-lesion,~     non-inflammatory site identified and marked for all instrumental and biopsy evaluations at~     Baseline and subsequent visits. Instrumental evaluations, imaging, expert visual grading and~     self-assessments will be performed throughout the study. Tolerability will be evaluated by~     incidence of AE's (defined per CTCAE), exacerbation of AD lesions, application site~     reactions/infections, and lab evaluations throughout the study. There will be additional~     consumption and compliance checks as well as dermatologic evaluations to ensure the subject's~     condition does not become extensively worse at each visit. A subset of subjects will have 2mm~     punch biopsies collected from the designated lesion and non-lesion sites at 3 time points~     throughout the study. The subset of subjects will be determined by subject willingness to~     participate in the biopsy portion as well as dermatologic evaluation and determination of~     biopsy candidacy.~   "
63779|NCT02732132|"~     The primary aim of this study was to investigate the efficiency and safety of midazolam plus~     ketamine versus fentanyl plus propofol administered to children undergoing UGE and to~     determine the most appropriate sedation protocol.~   "
63780|NCT02732119|"~     The purpose of this study is determine if the triplet combination of ribociclib, everolimus~     and exemastane is effective in the treatment of locally advanced/metastatic breast cancer~     following treatment with a CDK 4/6 inhibitor~   "
63767|NCT02732288|"~     Patients with severe brain injuries often have slow accumulating recoveries of function. In~     ongoing studies, we have discovered that elements of electrical activity during sleep may~     correlate with the level of behavioral recovery observed in patients. It is unknown whether~     such changes are causally linked to behavioral recovery. Sleep processes are, however,~     associated with several critical processes supporting the cellular integrity of neurons and~     neuronal mechanisms associated with learning and synaptic modifications. These known~     associations suggest the possibility that targeting the normalization of brain electrical~     activity during sleep may aid the recovery process. A well-studied mechanism organizing the~     pattern of electrical activity that characterizes sleep is the body's release of the~     substance melatonin. Melatonin is produced in the brain and released at a precise time during~     the day (normally around 8-10PM) to signal the brain to initiate aspects of the sleep process~     each day. Ongoing research by other scientists has demonstrated that providing a small dose~     of melatonin can improve the regular pattern of sleep and help aid sleep induction. Melatonin~     use has been shown to be effective in the treatment of time change effects on sleep (jet~     lag) and mood disturbances associated with changes in daily light cues such as seasonal~     affective disorder. We propose to study the effects of melatonin administration in patients~     with severe structural brain injuries and disorders of consciousness. We will measure the~     patient's own timing of release of melatonin and provide a dose of melatonin at night to test~     the effects on the electrical activity of sleep over a three month period. In addition to~     brain electrical activity we will record sleep behavioral data and physical activity using~     activity monitors worn by the patients. Patient subjects in this study will be studied twice~     during the three month period in three day inpatient visits where they will undergo video~     monitoring and sampling of brain electrical activity using pasted electrodes (EEG), hourly~     saliva sampling for one day, and participation in behavioral testing.~   "
63768|NCT02732275|"~     This will be a First-in-Human, Phase 1, multi-center, non-randomized, open label study of~     DS-3201b, Histone-lysine N-methyltransferase EZH1/2 dual inhibitor to assess its safety and~     tolerability, identify a maximum tolerated dose (MTD)/ tentative recommended phase 2 dose~     (RP2D), and assess its pharmacokinetic/dynamic properties in Japanese subjects with~     Non-Hodgkin's Lymphoma.~   "
63769|NCT02732262|"~     Postoperative pain control is required after major abdominal surgery, including laparoscopic~     colorectal surgery. Intravenous oxycodone is widely used for postoperative acute pain control~     mainly in Europe.~      The aim of this study is to evaluate the optimal dose of intravenous oxycodone for pain~     control after laparoscopic colorectal surgery in Korean.~   "
63770|NCT02732249|"~     Standard triple therapy including a proton pump inhibitor (PPI) and clarithromycin with~     either amoxicillin or metronidazole are no longer recommended as empirical ﬁrst-line therapy~     to treat Helicobacter pylori infection because of high antibiotic resistance. It is unknown~     whether the addition of bismuth overcome antibiotic resistance. This study is designed to~     evaluate the efficacy and safety of the addition of bismuth to standard triple therapy for H.~     pylori first-line eradication.~   "
63771|NCT02732236|"~     Marginal zone lymphoma is a rare of subtype of Non-Hodgkin Lymphoma. Because of its rarity,~     prospective clinical trial is difficult to conduct. Therefore we want to make prospective MZL~     patients' cohort for several observation study~   "
63772|NCT02732223|"~     Atherosclerosis, one major cause of morbidity and mortality worldwide, is a complex and~     multifactorial disease triggered especially due to high level of plasma lipids and that~     involves three mainly conditions: chronic inflammation, dyslipidemia and oxidative stress.~     Taking into account the high costs of disease management, eminent suboptimal response and low~     compliance to drug therapies, the combined use of natural bioactive compound able to reduce~     atherosclerosis risk could provide an additional protection. In this study, the effects of~     three bioactive components, namely omega-3 fatty acids, plants sterols and polyphenols~     present in green tea, will be evaluated over atherosclerosis biomarkers in individuals with~     dyslipidemia controlled by drugs. It will be carried out a randomized, double-blind,~     placebo-controlled, crossover clinical study, with participation of 70 subjects. At each~     intervention period, study participants will receive a packaged for the functional or placebo~     treatment. Functional treatment packaged will be composed by omega 3 softgels (fish oil), a~     chocolate containing plant sterols and green tea. Placebo treatment will be composed by corn~     oil softgels, regular chocolate, and anise tea. Subjects will be advised to consume the~     softgels and chocolate twice a day after main meals and to drink two cups of tea per day.~     After evaluation of inflammation, dyslipidemia and oxidative stress biomarkers, subjects with~     the greatest response to the functional treatment will be selected for additional 6 weeks of~     functional intervention associated to a reduction of the hypolipidaemic drugs intake, which~     will be prescribed individually after evaluation of the responsible physician.~   "
63773|NCT02732210|"~     The objective of this study was to describe persistence with Prolia® 60 mg administered~     subcutaneously (SC) every 6 months (Q6M) at 12 and 24 months.~   "
63774|NCT02732197|"~     Background: This study was designed to investigate the effect of sedation on the occurrence~     of maternal hypotension in preoperatively anxious parturients undergoing urgent category-1~     Cesarean section (C/S) under spinal anesthesia.~      Methods: After institutional ethics committee approval, prospectively collected data of 1824~     parturients undergoing C/S were reviewed. Parturients with high preoperative anxiety scores~     (visual analogue scale for anxiety (VAS-A)≥70) undergoing C/S under spinal anesthesia with~     thiopental (Group S=49) and without any other type of sedation (Group NS=53) were included in~     the analysis. Hemodynamic parameters were documented and maximum systolic arterial pressure~     (SAP) reductions from the baseline after spinal anesthesia were calculated. Incidences of~     hypotension (SAP≥30% decrease from baseline or <100 mmHg) and bradycardia (HR<55 beats/min),~     and related-ephedrine and -atropine requirements were noted. Our primary endpoint was to~     compare the maximum SAP reductions from the baseline values in Groups S and NS. Secondary~     endpoints were incidences of hypotension and bradycardia, required ephedrine and atropine~     doses, newborn Apgar scores at 1st and 5th min.~   "
63775|NCT02732184|"~     This is the first study of the safety of increasing dose levels of AEB1102 in patients with~     Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome. The study will~     also evaluate the amounts of AEB1102 in blood, the effects of AEB1102 on blood amino acid~     levels and the antitumor effects of AEB1102.~   "
63776|NCT02732171|"~     This is a single center, prospective cross-sectional study of women who have completed~     therapy for primary breast cancer within 5 years of diagnosis and are at increased risk for~     relapse.~      Patients will undergo screening bone marrow aspirate to test for presence of disseminated~     tumor cells (DTCs) Patients who harbor DTCs will be offered the opportunity for enrollment~     into a clinical trial of therapy targeting DTCs to prevent recurrence (separate protocols).~   "
63777|NCT02732158|"~     This prospective, nonrandomized, feasibility study will compare laboratory measures at the~     beginning and end of the study period in adults consuming a nutritional study product.~   "
63778|NCT02732145|"~     To determine the sensitivity and specificity of Three Rings Vulvoscopy for detection of~     vulvar dermatosis using histopathology as the reference standard.~   "
63781|NCT02732106|"~     Human adipose tissue is now recognized as an acceptable, highly abundant source of~     adipose-derived regenerative cells (ADRCs). ADRCs are a heterogeneous or mixed population of~     cells found in adipose tissue including adult stem cells, leukocytes, connective tissue and~     vessel-associated cells. Autologous adult regenerative cells are thought to promote healing~     of scarred or injured tissue. While the investigators are learning more about the exact~     mechanisms every day, it is believed that this heterogeneous population of cells influences~     the local environment via cell-to-cell signaling, immune modulation, and differentiation into~     other cell types. The use of ADRCs in the treatment of many different medical conditions~     (including cardiovascular disease, soft tissue defects, wound healing, and many more) is~     being evaluated in numerous clinical and preclinical studies around the world. While there is~     a considerable amount of information regarding the cellular composition of ADRCs isolated~     from healthy donors, basically there is no much data regarding the ADRC composition from~     cardiac patients. In this study, adipose tissue or cells from chronic heart ischemia~     patients, that would otherwise be thrown away in waste, will be provided to researchers who~     will study these cells with the objective to characterize ADRCs derived from patients with a~     heart disease and to compare if a heart disease state does impact ADRC cell composition.~   "
63782|NCT02732093|"~     In this study investigators will evaluate the effect of stellate ganglion block on stress~     response of intubation in comparison to traditional antistress measures in adult patients~   "
63783|NCT02732080|"~     After reopening of the infarct related artery by primary percutaneous coronary interventions~     (PPCI), microvascular damage at the related myocardial territory is not terminated~     immediately. This ongoing nature of microvascular damage leading to myocardial malperfusion~     is related to final infarct size. However, time course of the microvascular impairment~     /obstruction after PPCI in patients presented with ST-elevating acute myocardial infarction~     (STEMI) is not known. Routine primary percutaneous coronary interventions (PPCI) for~     ST-elevation acute myocardial infarction (STEMI) includes balloon angioplasty (or~     thrombectomy) followed immediately by stent implantation. However, stent implantation~     performed in this thrombotic setting may lead to a further microvascular damage by causing~     more distal embolisation and by inducing distal microvascular spasm by stretching the~     coronary vessel wall. Furthermore, sudden exposure of distal microcirculation to a high~     distal intracoronary pressure achieved by immediate stent implantation may exaggerate~     myocardial oedema which contributes microvascular damage substantially by external~     compression. However, results of studies investigating the efficacy of delayed stenting~     (24-48 hours later) in patients in whom TIMI -3 flow was achieved after balloon angioplasty~     were inconsistent.~      In this study, STEMI patients undergoing PPCI, in whom epicardial reperfusion was achieved~     (TIMI-3 flow) by wire crossing or by balloon angioplasty or aspiration thrombectomy, will be~     randomised to immediate and delayed stenting groups. Delayed stenting will be performed at~     the time when coronary auto regulation was recovered which is going to be determined based on~     the continuous intracoronary hemodynamic monitoring after reperfusion.~   "
63784|NCT02732067|"~     Death rate in anesthesia is one of the most valuable methods to assess the safety of~     anesthesia practice among different types of patients.~      In this study, the investigators will follow the death among patients who underwent surgery~     under anesthesia whether regional or general over the next two years from 2016 to 2018.~   "
63785|NCT02732054|"~     This study aimed to evaluate the efficacy of different hepatitis B vaccination regimens in~     HIV-infected adults with low CD4 cell count in northern Thailand.~   "
63786|NCT02732041|"~     Asynchrony during mechanical ventilation has been poorly described in patients suffering from~     acute respiratory distress syndrome. The purpose of this study is to describe the frequency~     of asynchronies (ineffective efforts and double triggering) in these group and evaluate~     potential risk factors and prognosis implications.~   "
63787|NCT02732015|"~     The goal of this clinical research study is to compare rolapitant with fosaprepitant in~     controlling or preventing nausea and/or vomiting that may be caused by chemotherapy in~     patients with sarcoma.~   "
63788|NCT02732002|"~     Work-related injuries of the shoulder complex represent a challenge for clinicians due to the~     large variety of clinical entities involved and the broad anatomic structures that are~     potentially affected. Furthermore, commonly performed orthopedic tests have demonstrated~     limited accuracy for the actual diagnosis of the injury. Although considerable research has~     been performed to standardize a model for shoulder injury management, a comprehensive~     approach integrating both a clinical and functional based status of the pathology and adapted~     rehabilitation prescription remains lacking.~      The present study protocol aims to complement previously published shoulder injury management~     algorithms. Potentially, the multi-component, individualized and progressive multi-etiologic~     shoulder injury management model for rehabilitation could become a new effective strategy for~     reducing the time required to regain functional capacity and symptom recovery among patients~     with work-related shoulder injuries.~   "
63789|NCT02731989|"~     In addition to the manual preoperative examination, the undescended testicle will be measured~     ultrasonographically. The compared data will help us to evaluate the routine need for~     preoperative ultrasonographic evaluation of the undescended testicle.~   "
63790|NCT02731976|"~     Changes in the gut microbiomes of healthy volunteers who followed a gluten-free diet (GFD)~     for four weeks were studied. Per participant, nine stool samples were collected: one at~     baseline, four during the GFD period, and four when they returned to their habitual diet.~     Microbiome profiles were determined using 16S rRNA sequencing and the samples were next~     processed for taxonomic and imputed functional composition. Additionally, participants kept a~     3-day food diary and six gut health-related biomarkers were measured.~   "
63791|NCT02731963|"~     Colorectal surgery is highly associated with septic complications, therefore, multiple~     approaches have been used to reduce this complications, one of the most used is mechanical~     bowel preparation. Lately multiple studies have suggested that mechanical bowel preparation~     might not be necessary.~   "
63829|NCT02731469|"~     BCD-131 is pegylated darbepoetin beta. BCD-131-1 is open clinical trial to evaluate~     pharmacokinetics, pharmacodynamics, tolerance, safety and immunogenicity of single injection~     of increasing doses of BCD-131 to healthy volunteers compared to Mircera® and Aranesp®.~     Clinical trial will be conducted in two stages. On first stage the optimal dose for~     therapeutic use of BCD-131 will be determined (subcutaneous injections). On second stage the~     determined dose will be injected subcutaneously and intravenously.~   "
63792|NCT02731950|"~     Effective pain relief after cardiac surgery has assumed importance with the introduction of~     fast track discharge protocols that requires early weaning from mechanical ventilation.~     Inadequate pain control reduces the capacity to cough, mobility, increases the frequency of~     atelectasis, and prolongs recovery. Infiltration of local anesthetics near the surgical wound~     has shown to improve early postoperative pain in various surgical procedures.~      Magnesium is the fourth most plentiful cation in our body. It has antinociceptive effects in~     animal and human models of pain.~   "
63793|NCT02731937|"~     The main purpose of this study is to collect clinical raw scan data and Scanner user feedback~     using dual energy CT (computed tomography) scan modes on the investigational CT scanner.~     Additionally, image quality using prototype reconstruction algorithms that are in development~     will be evaluated and compared to standard-of-care images acquired with regulatory cleared~     diagnostic CT scanners for feasibility assessment and engineering development. Compared to~     standard clinical single energy (kilovolt,kV) scanning, dual energy (kV) scanning s provides~     more information about the material composition of the scanned patient and may allow for~     improved tissue, tumor characterization, and improved image quality.~   "
63794|NCT02731924|"~     The primary purpose of this study is to determine the accuracy of ultrasound (US) in~     diagnosing appendicitis in emergency department (ED) patients, as compared to the criterion~     standards of computed tomography, operative reports, or discharge diagnosis.~      The secondary purposes of the study include evaluation of the effect of ultrasound for~     appendicitis on the patient length of stay in the emergency department, the diagnostic~     utility of specific ultrasound findings in the diagnosis of appendicitis, the role of body~     mass index (BMI) in the utility of ultrasound for appendicitis and relation of ultrasound~     findings to the Alvarado score. The study will also examine the inter-rater agreement between~     point-of- care sonographers' interpretation and blinded reviewers' interpretation of the~     ultrasound images.~   "
63795|NCT02731911|"~     This prospective study will assess Ozurdex in the treatment of Diabetic Macular Oedema in~     clinical practice.~   "
63796|NCT02731898|"~     A prospective, international and multicenter, non interventional single-cohort study, which~     will enroll consecutive adult patients who have received mechanical ventilation (invasive and~     noninvasive ventilation) for at least 12 hours during a 1-month period, and will follow each~     patient for the duration of mechanical ventilation, up to 28 days. The main objectives will~     be to analyze the mortality and clinical outcomes in ventilated patients and secondly, to~     evaluate the practices of liberation from mechanical ventilation, the failure of non invasive~     ventilation in the ICU, and to analyze the clinical outcomes in specific populations of~     critically ill patients with the need of mechanical ventilation.~   "
63797|NCT02731885|"~     The goal of this study is to determine the impact of the food on the absorption of the~     ABX464.~   "
63798|NCT02731872|"~     The purpose of our study is to establish whether domiciliary use of the Airvo warm passover~     humidifier can reduce the number of exacerbations in patients with respiratory insufficiency.~     Participants must have a diagnosis of chronic obstructive pulmonary disease (COPD) and be in~     long term oxygen therapy (LTOT). The following questions will be investigated:~      Do outpatients receiving long term oxygen therapy benefit if this is delivered through an~     Airvo humidification system. The proposed benefits under investigation are:~        1. a reduction in the number of exacerbations and thus hospital admissions?~        2. an increase in quality of life (QOL)?~        3. an improved lung function and thus increased physical activity?~   "
63799|NCT02731859|"~     The purpose of this study ist to determine long-term safety and efficacy in weight reduction~     and improvement of diabetes mellitus of the temporary, endoscopic duodenal-jejunal~     bypass-sleeve EndoBarrier® in a national registry.~   "
63800|NCT02731846|"~     The primary purpose of this study is to assess the equivalence of closed triple therapy~     Fluticasone Furoate (FF)/Umeclidinium (UMEC)/Vilanterol (VI) to open triple therapy (FF/VI +~     UMEC), with a comparison of both triple therapies to dual therapy (FF/VI) on lung function.~      This is a phase III, 4-week, randomized, double-blind, parallel group, multicenter study~     comparing FF/UMEC/VI (100 micrograms [mcg]/62.5 mcg/25 mcg) delivered via a single ELLIPTA®~     inhaler ('closed' triple) + matching placebo ELLIPTA inhaler, FF/VI + UMEC delivered via two~     ELLIPTA inhalers ('open' triple) and FF/VI via a single ELLIPTA inhaler + matching placebo~     ELLIPTA inhaler, all once daily. The total duration of subject participation will be~     approximately 7 weeks, consisting of a 2-week run-in period, 4-week treatment period and a~     1-week follow-up period.~      ELLIPTA is a registered trade mark of the GSK group of companies.~   "
63801|NCT02731833|"~     This single centre, comparative design study will be used to investigate the efficacy of an~     experimental stannous fluoride containing dentifrice in relieving dentinal hypersensitivity~     (DH) after short term use compared with a standard fluoride dentifrice~   "
63802|NCT02731820|"~     The purpose of this study is to investigate whether the use of alkali compounds, i.e.~     potassium citrate (K3C6H5O7, hereinafter KCitr) is effective in preventing the progression of~     osteopenia.~      A randomized clinical trial (RCT, placebo-controlled, double-blind) has been planned to~     evaluate the effect of the daily administration of KCitr (3 g/die, K 30 mEq).~      The efficacy will be evaluated by comparing the circulating levels of bone turnover markers~     at the baseline and after the treatment (3, 6 months).~   "
63803|NCT02731807|"~     This study is a pilot research study in humans to determine the steady state pharmacokinetic~     profile of TA-65 after oral dose of formulated and unformulated forms. There will be eight~     (8) subjects of healthy men and women (non-child bearing). TA-65 is supposed to supplement~     the diet to increase general health through telomerase activation.The active ingredient in~     TA-65 activates an enzyme called telomerase. However, the active ingredient has poor oral~     bioavailability in humans. This study is created to enhance the bioavailability in telomerase~     with different formulations; powder and capsule form.~   "
63804|NCT02731794|"~     The investigators designed the randomized prospective study to evaluate the differences of~     inflammatory response and clinical outcome after on-pump beating coronary artery bypass~     grafting undergoing left ventricular assist versus biventricular assist in patients with~     severe left ventricle dysfunction.~   "
63830|NCT02731456|"~     Prospective interventional trial in lowlanders evaluating the effect of acute exposure,~     acclimatization and re-exposure to high altitude on psychomotor vigilance to measure~     sustained attention.~   "
63805|NCT02731781|"~     Traumatic brain injury (TBI) is the major cause of disability and death among the younger~     population. In the Pediatric population Head trauma may be responsible for primary and~     secondary brain damage. Primary brain injury results from a direct mechanical damage at the~     time of injury, whereas secondary injury is caused by further cellular damage that develops~     hours or days post injury. Intracranial Injury in Infants (III) may be hard to diagnose in~     the abcence of neurological deficit or early deterioration. On the other hand, symptoms such~     as vomiting and restlessness may be present even in the case of minor head injury, and~     unnesessary scaning (CT) may be performed in many centers just because clinical judgment is~     problematic in this particular age. Some intracranial injuries may be imminent, such as~     evolving Epidural hematoma (EDH) in infants, and early diagnosis may be lifesaving and~     leading to excellent outcome. In adults, GCS has been accepted as the most usuful tool for~     emergency evaluation of head injured patients. In children, several scores were introduced,~     including the Children's Coma Score (CCS), however they have been found problematic to use in~     the very young population, since accurate evaluation of communication in CCS is hard, and~     there is insufficient relevant parameters uncorporated into the score that may have~     significant importance in this particular age group. In TINS (Trauma Infant Neurological~     Score) we characterized the clinical parameters and the mechanism of trauma in a simplified~     method. As previously published, this score has been used by us and by other groups, in~     retrospective studies. Still, in the lack of prospective studies using TINS, there are no~     optimal guidelines to perform computed tomography (CT) in this unique population, and TINS~     has not prospectively been challenged as a predictor tool for outcome. In this prospective~     study we will approach these issues.~   "
63806|NCT02731768|"~     The purpose of this study is to evaluate whether a social support-enhanced, technology-based,~     behavioral weight control intervention can improve weight loss over existing best practices.~   "
63807|NCT02731755|"~     A diet rich in whole grain is inversely associated with cardiovascular disease risk. Whole~     grains contain a wide range dietary components including potentially vasoactive phenolic~     acids. In this proposed human trial, the investigators aim to establish whether consumption~     of one portion of phenolic acid-rich oats leads to acute improvements (i.e. 1-24h~     post-intake) in markers of cardiovascular disease risk relative to an energy matched control~     intervention in healthy men with high-normal to mildly elevated blood pressure.~   "
63808|NCT02731742|"~     This is a non-randomized, open-label study of MK-1966 used in combination with SD-101 in the~     treatment of advanced malignancies. The study will include an initial Dose Evaluation phase~     to determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) by evaluating~     Dose Limiting Toxicities (DLTs) on four dose combinations of MK-1966 and SD-101. Following~     determination of the MTD/MAD, approximately 20 participants each will be enrolled in two~     expansion cohorts to confirm/refine the MTD/MAD.~   "
63809|NCT02731729|"~     The purpose of this research study is to learn whether patients whose disease grows after~     being treated with nivolumab or pembrolizumab respond to ipilimumab (Yervoy®) alone or in~     combination with nivolumab (Opdivo®).~   "
63810|NCT02731716|"~     To design an innovative payment system that improves upon fee-for-service (FFS), incorporates~     behavioral economic principles, and improves work satisfaction among primary care physicians~     (PCPs) while improving quality and reducing health spending at the state level. Second, to~     test the incremental effectiveness of two additional interventions: (1) shared financial~     incentives between physicians and poorly controlled diabetes and (2) social comparisons~     ranking physicians on quality metric performance and total cost of care.~   "
63811|NCT02731703|"~     This study will identify and enroll patients already scheduled to receive guided maxillary~     implant placement with palateless overdenture. Standard clinical practice will be followed~     for this multi-stage process. The study purpose is to evaluate the degree of satisfaction~     during the standard progression in order to determine at which post edentulous stage patients~     achieve maximum satisfaction using the Oral Health Impact Profile 49 (OHIP 49).~   "
63812|NCT02731690|"~     This is an open-label multi center study to evaluate the safety of Aceneuramic Acid Extended~     Release (Ace-ER) Tablets for patients with GNE Myopathy.The primary objective of this Phase 2~     study is to evaluate the safety of open-label 6 g/day Ace-ER in GNEM subjects with severe~     ambulatory impairment. The study will also assess efficacy to ensure that the full spectrum~     of patients with GNEM are evaluated.~   "
63813|NCT02731677|"~     Sleep disorders correspond to a non-motor symptom present in DP, being represented by daytime~     sleepiness and maintenance insomnia. This study aims to evaluate the effects of acupuncture~     on sleep disorders in patients with PD assisted by Pró-Parkinson Program at University~     Hospital of Pernambuco, Brazil. Its a randomized clinical trial approved by the Ethics~     Committee for Research with Human. It was included patients with diagnosed with Idiopathic~     Parkinson's disease, Mini Mental State Examination (MMEE) according to education, stages 1, 2~     and 3 in the Hoehn-Yahr scale. It was used the sleep Scale for Parkinson's disease (PDSS), a~     self-administered scale designed to assess nighttime sleep problems, sleep disorders and~     excessive daytime sleep. Twenty-two subjects were allocated in two groups: experimental and~     control. Acupuncture was applied on the acupoints F3 - BP6- VB34- IG4 - TA5 - C7 - PC6 - IG11~     - VB20 - XIAOCHANXUE once a week, eight sessions in the experimental group. The control group~     no suffered intervention. The paired analyzes were performed using the Wilcoxon test and the~     independent analyzes using the Mann-Whitney test.~   "
63814|NCT02731664|"~     The inhibitory effect of low dose GLP-1 is investigated on prandial motility of the stomach,~     duodenum and jejunum in vivo in humans. Supplementary in vitro studies on the mechanism of~     action of the GLP-1 inhibition of motility as carried out on muscle strips from the upper~     gastrointestinal tract in man.~   "
63815|NCT02731651|"~     Laparoscopic surgery has played a pivotal role in all surgical fields in modern medicine. It~     has some well known advantages over open surgery. For this reason laparoscopic surgery is~     know the first choice for many surgical procedures, even in gynecology. On the other hand,~     despite the advantages of laparoscopy carbon dioxide (CO2) pneumoperitoneum is not free from~     side effects. Experimental studies and limited clinical studies showed that pneumoperitoneum~     leads to a decrease in the blood flow to intra-abdominal organs during laparoscopic surgery.~     This is also known as ischemia, leads to the production of free O2 radicals. The desufflation~     of the abdominal cavity at the end of the procedure reduces the increased abdominal pressure~     and increase the perfusion of intra-abdominal organs. However this will not stop the~     production of free radicals. This reperfusion period even exaggerate the release of free~     radicals. This phenomenon is called as ischemia/reperfusion (I/R) model that leads to release~     of various free radicals, which are the most important mediators of oxidative tissue injury~     and consequential organ dysfunction. Recently both oxidative tissue injury and consequential~     dysfunction have been shown in ovarian tissue in experimental animal studies. But the data~     related to human ovary is still scarce. Thus the aim of the study is to evaluate the effect~     of I/R injury related to CO2 pneumoperitoneum on human ovary.~   "
63816|NCT02731638|"~     Mycotic Antimicrobial Localized Injection (MALIN) is a randomized, masked, two-arm clinical~     trial investigating intrastromal voriconazole in the treatment of fungal corneal ulcers.~     There is currently little evidence to guide the treatment of fungal keratitis beyond topical~     anti-fungal drops, though intrastromal voriconazole and oral antifungal treatments are used~     as well. This study will provide evidence to guide the treatment of fungal keratitis in the~     future. The purpose of this study is to determine differences in microbiological cure for~     3-day repeat cultures between different antifungal treatments. For this study, there will be~     1:1 randomization to one of these two treatment groups: 1) topical natamycin plus~     intrastromal voriconazole injection or 2) topical natamycin alone.~   "
63817|NCT02731625|"~     The purpose of this study is to investigate the performance benefits of supplementing Army~     standard Physical Readiness Training (PRT) with a defined kettlebell (KB) deadlift and swing~     training program as compared to standalone PRT. Power and performance will be measured on~     horizontal (broad) and vertical jumps, 40 yard sprint, 60 yard shuttle, and the Army Physical~     Fitness Test (APFT). It is hypothesized that the unique force distributions of kettlebell~     training will promote improved power, particularly across the horizontal plane, when compared~     to standalone Army PRT. Findings will potentially provide insight as to how Army units can~     effectively utilize kettlebells to further diversify their training programs.~   "
63818|NCT02731612|"~     This is a randomized, double-blind, placebo-controlled, multicentre, parallel-group study to~     assess the cognitive effects of lurasidone in bipolar I and II patients (manic depression)~     who are in remission from an episode. Participants who show cognitive impairment at the~     screening visit will be enrolled into the study and randomized at the baseline visit to~     receive either lurasidone or placebo adjunctive therapy in a 1:1 ratio for 6 weeks.~   "
63819|NCT02731599|"~     The first aim of this study was to evaluate the effect of a gait training using treadmill~     with visual and auditory cues in patients in stages IV Hoehn & Yahr (H&Y). The second aim was~     to compare the obtained data of these patients in advanced stages with those in mild to~     moderate stages.~   "
63820|NCT02731586|"~     As Regenerative Medicine is the next level in medicinal sciences, the use of mesenchymal~     cells have become prevalent, Similarly now stem cells are being used in dental research as~     well in various clinical applications.This study aims to evaluate the overall effect of~     osseointegration by use of Allogenic Mesenchymal Stem cells while placing dental~     implants.Healthy subjects will be chosen and dental implants placed bilaterally one with~     standard surgical protocol and other with the use of Allogenic Mesenchymal Stem cells.The~     implant stability is checked using Resonance frequency analysis(RFA).The RFA values are~     statistically evaluated at various intervals and observations will be analysed on both test~     and control side.~   "
63821|NCT02731573|"~     This study is aimed to assess the anti-infective efficacy of D-PLEX over a period of 3 months~     post operation as well as the safety over a period of 6 months, by preventing sternal~     infection post cardiac surgery in patients above the age of 18, including high risk patients~     for infection. This study is a 2 parts study: part 1 is a single arm, part 2 is randomized~     controlled study.~   "
63822|NCT02731560|"~     A study to determine the efficacy and safety of rituximab in Pakistani patients with~     rheumatoid arthritis (RA) who have been inadequately controlled with standard disease~     modifying anti rheumatic drugs (DMARDs).~   "
63823|NCT02731547|"~     A two armed randomized trial is evaluating the effect of the medical-student-delivered~     school-based intervention Education Against Tobacco on the smoking behavior of adolescents in~     7-11th grade of secondary schools in Bosnia and Herzegovina. The primary endpoint is the~     change in smoking prevalence between the two groups.~   "
63824|NCT02731534|"~     The purpose of this study is to confirm the non-inferiority of Z-213 compared to Saccharated~     Ferric Oxide using the maximum change in Hb from baseline over 12 weeks in patients with~     Iron-deficiency Anemia (IDA)~   "
63825|NCT02731521|"~     The Investigators will examine the disease specificity of 2-hydroxyglutarate in non-glioma~     brain lesions, and the clinical utility of 2-hydroxyglutarate, glycine and citrate in~     isocitrate dehydrogenase (IDH) mutated gliomas and IDH wild type gliomas.~   "
63826|NCT02731508|"~     Non-invasive repetitive bi-hemispheric transcranial direct current stimulation (tDCS) may~     restore post-stroke bi-hemispheric balance by increase peri-lesional cortex activity and~     suppress abnormal inhibition from non-lesional hemisphere, and therefore enhance~     after-effects of rehabilitation. In this double-blind, randomized controlled trial,~     investigators aim to investigate whether multi-session, bihemispheric tDCS to the primary~     motor cortex (M1) in combination with upper extremity rehabilitation therapy affected motor~     functional outcome, ipsilesional motor circuit excitability using transcranial magnetic~     stimulation (TMS) and magnetoencephalography (MEG) measures.~   "
63827|NCT02731495|"~     Traumatic brain injury is the leading cause of death and disability in young adults. Green~     tea Epigallocatechin -3-gallate (EGCG) supplementation might favorably influenced many of the~     processes mention in the secondary insult of TBI including neuroinflammation and~     antioxidative damages.~      The investigators aim to investigate whether treatment with Epigallocatechin -3-gallate~     favorably affect outcomes in traumatic brain injury patients. Therefore, in the current~     randomized double-blind clinical trial, 30 patients (15 patients in each group) with moderate~     to severe head trauma admitted to university hospital intensive care unit will included.~     Patients will either receive a daily oral dose of 400 mg EGCG or placebo for 7 days. The~     major outcomes includes duration of mechanical ventilation, Glasgow Coma Scale (GCS), and~     S100 protein level.~   "
63828|NCT02731482|"~     This study will investigate the short-and long-term effects of the home-based pulmonary~     rehabilitation on peripheral muscle strength, functional capacity and quality of life in~     patients with bronchiectasis. The participants will be randomized into two groups: control~     group (usual care and recommendations for practice exercise) and training group, that will~     perform aerobic (stepping training) and resistance training (lower and upper limbs) for eight~     weeks, three times a week. At baseline, immediately after finishing and after six months the~     patients will undergo assessments.~   "
63848|NCT02731222|"~     The objective of this study is to determine the degree of correlation between the clinical~     severity of chronic venous disease and the prevalence of onychodystrophy. The completion of~     the study will require a previous synthetic explanation of the aforementioned two diseases,~     emphasizing the factors which have an impact on the proposed analysis.~   "
63831|NCT02731443|"~     Prospective observational study on epilepsy patients undergoing partial brain resection~     surgery (i.e. anterior temporal lobectomy) to assess the change in dream content before and 3~     months and 1 year after surgery using anonymized dream-recall questionnaires. A control group~     of epilepsy patients undergoing diagnostic depth electrodes placement will complete the same~     questionnaires pre- and postoperatively to asses the factor 'general anesthesia' as a~     potential confounder.~   "
63832|NCT02731430|"~     this study compares the use of intrathecal morphine, to multimodal analgesic techniques for~     postoperative pain management following laparoscopic bariatric surgery.~   "
63833|NCT02731417|"~     There are no set national guidelines for the management of postpartum bladder. There is~     little evidence on the management of postpartum urinary retention and many hospitals have~     implemented their own postpartum bladder care protocols.~      Acupuncture has been implemented as an alternative course of treatment for urinary retention~     with reports of spontaneous restoring of micturition in all of the patients. The~     investigators aimed at examining if acupuncture is a useful tool to treat postpartum urinary~     retention.~   "
63834|NCT02731404|"~     Background: Positive pressure pneumoperitoneum (PP) may involve adverse pathophysiological~     changes, including increased intra-thoracic and ocular pressure, when combined with standard~     ventilation. High frequency jet ventilation (HFJV) was reported to reduce the adverse~     cardiovascular effects during laparoscopic cholecystectomy.~      Aim: To study the effects of HFJV on intra-ocular pressure changes (reflecting intra-cranial~     pressure) during laparoscopic surgery under PP.~   "
63835|NCT02731391|"~     To study the prevalence of bowel symptoms in patients with pelvic organ prolapse.~   "
63836|NCT02731378|"~     A multicentre, randomized, open-label, parallel-group, active controlled non-inferiority~     study~   "
63837|NCT02731365|"~     The purpose of this clinical study is to allow the investigation of local field potential~     (LFP) signals in patients treated with DBS of the STN. This study will identify common LFP~     biomarkers observed as a function of disease symptoms, medication effect, fluctuations in~     disease, and changes resulting from adjustments from current standard practices of DBS~     programming. The data collected and LFP markers identified will serve as guidelines for~     future stimulation predicted programming.~   "
63838|NCT02731352|"~     The purpose of this study is to assess the efficacy and safety of apatinib in locally~     advanced 131I-refractory/resistant differentiated thyroid cancer~   "
63839|NCT02731339|"~     The aim of this study was to investigate the relationship among sagittal spinal curvatures,~     mobility, and low back pain in women with and without urinary incontinence.~   "
63840|NCT02731326|"~     Atrial fibrillation (AF), a condition where the top chambers of the heart beat irregularly,~     is a major health problem. The long-term goal of this project is to use a personal, mobile~     heart monitor to help patients better recognize recurrent AF and improve patients' ability to~     better manage their condition. A total of 300 patients with a history of AF will be included~     in the study, with 150 patients receiving an iPhone with the mobile monitoring device and~     educational text messaging and the remaining 150 patients continuing with their regular~     medical care. Each patient will be included in the intervention period for 6 months. The rate~     of recurrent AF and treatments meant to manage AF and other heart conditions will be~     determined for both groups. Patients in both groups will complete a series of questionnaires~     at the start and end of the 6 month study period to look at differences in quality of life~     and knowledge of AF.~   "
63841|NCT02731313|"~     The primary objective is to evaluate the concordance between human epidermal growth factor~     receptor 2 (HER2) status determined by the participating laboratory and by the centralized~     laboratory. HER2 status of samples was tested by the participating laboratories~     (investigator's choice of immunohistochemistry [IHC] and in situ hybridization [ISH] methods)~     and by the centralized laboratories (IHC using the 4B5 anti-HER antibody and Silver ISH).~     Positive HER2 status was defined as a score of IHC3+ or IHC2+/ISH+.~   "
63842|NCT02731300|"~     Background: Lennox-Gastaut syndrome (LGS) is a severe childhood epileptic syndrome with high~     pharmacoresistance. The treatment outcomes are still unsatisfied. The investigator previous~     study of cathodal transcranial direct current stimulation (tDCS) in children with focal~     epilepsy showed significant reduction in epileptiform discharges. The investigator~     hypothesized that cathodal tDCS when applied over the primary motor cortex (M1) combined with~     pharmacologic treatment will be more effective for reducing seizure frequency in participants~     with LGS than pharmacologic treatment alone.~      Material and Method:~      Study participants were randomized to receive either:~        1. pharmacologic treatment with 5-consecutive days of 2 milliampere (mA) cathodal tDCS over~          M1 for 20 min or~        2. pharmacologic treatment plus sham tDCS. Measures of seizure frequency and epileptic~          discharges were performed before treatment and again immediately post-treatment and 1-,~          2-, 3-, and 4-week follow-up.~   "
63843|NCT02731287|"~     Infantile hemangioma (IH) is the most common benign vascular tumor in pediatric population.~     Oral propranolol is the treatment of choice for complicated hemangiomas. Topical timolol, a~     non-selective beta-blocker, is an emerging treatment which has been reported to be effective~     and safe for the treatment of IH, especially for superficial hemangiomas. Investigators~     hypothesize that treatment with topical timolol in the first two months of life, before the~     proliferative phase or in early proliferative phase, may prevent from further growing and the~     need to treat with oral propranolol.~   "
63844|NCT02731274|"~     The main purpose of this study was to investigate if a six months period of physical~     exercise, could improve motor memory consolidation in elderly people on pedal dexterity~   "
63845|NCT02731261|"~     The main purpose of this study was to investigate if a six months period of physical exercise~     could improve motor memory consolidation in elderly people.~   "
63846|NCT02731248|"~     Pulse oximetry screening of newborn infants increases early detection of critical congenital~     heart disease and minimises the risk of circulatory collapse before surgery. This study~     provides an update on the implementation of pulse oximetry screening in Turkey~   "
63847|NCT02731235|"~     In a randomized-controlled study the effect of high-intensity training, 5 days a week at home~     for 12 weeks is tested in patients with lacunar stroke.~   "
67147|NCT02688036|"~     The purpose of this study is to determine whether hypofractionated concurrent~     chemo-radiotherapy has the same efficiency as conventionally fractionated concurrent~     chemo-radiotherapy in Limited Disease Small Cell Lung Cancer.~   "
63849|NCT02731209|"~     The aim of the investigators work is to describe the urodynamic results in the CKD (chronic~     kidney disease) grade 4 patients and to verify observations that urinary catheter may improve~     kidney function in those patients.~      100 patients with CKD grade 4 will do urodynamic examination.~      All patients will be randomized into two groups / the intervention group that will be~     inserted urinary catheter for 2 weeks and the follow up group. Kidney function will be~     monitored by creatinin values and the investigators will measure the time to dialysis in the~     two groups.~   "
63850|NCT02731196|"~     Low back pain is common, costly and affecting up to 80% of the population with the lumbar~     discectomy being a frequent spinal procedure for disc herniations. Pain & mobility~     impairments persist in patients following microdiscectomy with long term issues of back pain.~     The question remains as to why some patients recover quickly and without lasting difficulties~     while other patients persist with prolonged disability following the same surgery. The~     purpose of this study is to determine how to guide the patient towards full function and~     evaluate the timing to initiate strengthening, neurodynamics and a walking exercise program.~   "
63851|NCT02731183|"~     Chronic intestinal pseudo obstruction(CIPO) is a serious motility disorder with~     life-threatening condition, and it is often related with bacterial overgrowth. Fecal~     microbiota transplantation (FMT) results in restoration of the normal intestinal microbial~     community structure. The investigators planned to observe the eﬃcacy of FMT in the treatment~     of a series CIPO patients. Patients received FMT on 6 consecutive days through nasojejunal~     tubes and followed up for 8 weeks after treatment. Rate of clinical improvement and~     remission, feeding tolerance of enteral nutrition, CT score of intestinal obstruction, and~     gastrointestinal quality-of-life index(GIQLI) were evaluated.~   "
63852|NCT02731170|"~     this study is aimed to evaluate the effectiveness of an Multidisciplinary Intensive~     Rehabilitation Treatment in Advanced Stages of Parkinson's Disease.~      In the last years, several evidences highlighted the need of a multidisciplinary and~     intensive approach to achieve good results in early stage of disease.~      Hypothesis is that this approach is effectiveness also in moderate and advanced stages of~     disease~   "
63853|NCT02731157|"~     The objective of this proposal is to test the feasibility of red blood cell (RBC)~     rejuvenation to chronic transfusion in sickle cell disease (SCD) and the potential benefit of~     RBC rejuvenation in this population to determine if a larger clinical trial powered to~     definitively characterize the benefits of rejuvenation is warranted.~      This is a small pilot study is to see if restoring important energy molecules (ATP and~     2,3,DPG) in stored red blood cells before they are transfused, with a rejuvenating solution~     (Rejuvesol), offers any advantages to individuals over standard blood transfusion. Subjects~     will receive either rejuvenated (R) or standard (S) RBCs with each transfusion for 6~     transfusions (over approximately a 6-month period) in a pre-defined order to maximize~     detection of any signal.~   "
63854|NCT02731144|"~     In this pilot randomized prospective controlled trial the investigators intend to compare the~     use of a nutritional therapy based on caloric intake determined by indirect calorimetry and~     high protein intake with nutritional regimen based on 25 Kcal / kg / day and protein intake~     usually recommended for critically ill patients (1.4 to 1.5 grams / kg / day of protein).~   "
63855|NCT02731131|"~     This single-center, randomized, open-label, pilot study is designed to evaluate the efficacy~     and safety of 48 weeks of treatment with peginterferon alfa-2a alone versus in combination~     with ribavirin in participants with CHD.~   "
63856|NCT02731118|"~     Glaucoma is a complex and chronic eye disease which damages the optic nerve. One of the main~     risk factors for the progression of glaucoma is IOP.~      The aim of the study is to examine if Salovum, an anti-secretory factor (AF), can reduce the~     level of the intraocular pressure (IOP) in the eye of patients affected by glaucoma.~      Anti-secretory factor (AF) is an endogenous protein which controls the transport of water and~     ions across the cell membrane. AF plays an important part in the immune system and has an~     anti-secretory and anti-inflammatory effect.~      The investigators' hypothesis is that Salovum can restore a normal salt-water balance in the~     eye, which in turn would lower the IOP. This would eliminate or reduce the risk of subsequent~     visual impairments/neurological damage.~   "
63857|NCT02731105|"~     Study to compare two gels that are used to treat acne vulgaris. It will be compared the~     tolerability and effectivity following application of two combination topical acne products~     clindamycin 1% and 0.025% tretinoin gel (Acnatac® Gel), adapalen 0,1% and benzoyl peroxide~     2,5% gel (Epiduo® Gel).~   "
63858|NCT02731092|"~     To evaluate the safety and tolerability of three different lactoferrin doses in preterm~     infants~   "
63859|NCT02731079|"~     Sleeve gastrectomy is now the most commonly performed bariatric surgery. While many studies~     have evaluated factors that may minimize post-operative hemorrhage and staple-line leak, the~     investigators are unaware of any studies that compare outcomes between devices from the two~     main stapler manufacturers used in this surgery, Covidien and Ethicon. The purpose of this~     study is to compare intraoperative characteristics, such as time to create sleeve,~     intraoperative bleeding, and time needed to load each cartridge, and post-operative~     characteristics, such as any complication requiring readmission (leak or hemorrhage), further~     surgical intervention, and weight loss, between patients who underwent sleeve gastrectomy~     with Covidien devices and Ethicon devices. Currently the investigators predominantly use~     whatever device is cheaper, but cost should not be the primary decisive factor if one device~     is superior to the other. If one device has better clinical outcomes, it should be the~     preferred device regardless of cost. If neither proves superiority, the investigators can~     justify using cost to determine which device to use in patient care.~   "
63881|NCT02730793|"~     This study is designed as a masked, two center, randomized, placebo-controlled pilot study to~     evaluate the safety and efficacy of nasal and oral inhalation of 75 mg aztreonam in subjects~     with CF and lung infection due to PA. The study will involve two sites: Virginia Commonwealth~     University Medical Center (VCU) and Eastern Virginia Medical School (EVMS). Potential~     subjects will be identified in each site's CF clinic.~   "
63882|NCT02730780|"~     This study aims to assess the natriuretic peptide response to dietary salt loading in~     African-American individuals compared with white individuals.~   "
64442|NCT02723474|"~     Male and female subjects age 18-85 with lung disease will inhale 5ml/kg (patient body weight)~     hyperpolarized helium and will be scanned using MRI at 3 Tesla, to evaluate the Apparent~     Diffusion Coefficient (ADC), ventilation defect volume and percent ventilation.~   "
63860|NCT02731066|"~     This research will evaluate nutrition requirements for missions at high altitude (i.e. >7800~     feet above sea level) and the information obtained can be used to optimize nutrient content~     specifications for combat rations.~      The objectives are:~        1. Determine whether loss of lean body mass resulting from negative calorie balance over a~          22-d period at high altitude can be prevented by increasing dietary protein intake.~        2. Determine the efficacy of carbohydrate (glucose and fructose) supplementation on aerobic~          exercise performance at sea level, acute exposure to high altitude, and in response to~          22-d period of negative calorie balance at high altitude.~        3. Determine cognitive function, sleep patterns, and behavioral responses to high altitude~          and underfeeding.~        4. Determine appetite and eating behavior in response to high altitude and sustained~          underfeeding.~        5. Examine the effects of high altitude, negative calorie balance, dietary intake~          manipulations on gut health.~   "
63861|NCT02731053|"~     The purpose of this pilot study is to test the effectiveness of French adaptation of the~     Blues program, a school-based indicated depression prevention intervention. The program will~     be delivered by the endogenous psycho-social staff of 3 Montreal secondary schools to~     adolescents with sub-clinical depressive symptoms and compared to a no-intervention~     (Informational Brochure only) control condition, designed to represent the usual~     intervention in these schools.~   "
63862|NCT02731040|"~     The purpose of this study is to determine whether women who have atypical subtrochanteric and~     diaphyseal femoral fractures after treatment with bisphosphonates for osteoporosis, have a~     genetic predisposition to these unusual fractures.~   "
63863|NCT02731027|"~     The purpose of the study is to profile biochemical responses and measure functional recovery~     in parallel, throughout the 1st year after spinal cord injury (SCI), within the same~     participants. These responses and recovery will be evaluated in samples from people who have~     had a spinal cord injury due to trauma (e.g. car accident or a fall) within the first year~     after SCI. Specifically, the investigators will test the hypothesis that a subset of~     inflammatory biomarkers correlate inversely with functional recovery. The investigators will~     use these data to build a predictive model of functional recovery after SCI that incorporates~     biomarkers that can be easily quantified in the clinic.~      Total anticipated enrollment will be 100 participants with SCI across three different sites~     (Northwell Health System (NY), The Kessler Institute for Rehabilitation (NJ), University of~     Louisville (KY) and may enroll up to 30 participants without SCI.~   "
63864|NCT02731014|"~     The aim of this trial will be to examine the short and long term effectiveness of dry~     needling on pain, disability, and patient perceived improvements in patients with neck pain~     attending physical therapy. The investigators hypothesize that patients who receive dry~     needling, manual therapy, and exercise will achieve greater reductions in pain and disability~     in the short (4 weeks) and long term (6 and 12 months) compared to those who receive sham dry~     needling, manual therapy, and exercise.~   "
63865|NCT02731001|"~     The aims of the study are to reduce acute radiation induced side effects, i.e. pneumonitis~     and esophagitis grade II or higher by the use of proton therapy compared to photon~     radiotherapy of equal total dose. Secondary endpoints include evaluation of quality of life,~     loco-regional control, survival and late radiation induced side effects.~   "
63866|NCT02730988|"~     Intentional weight loss in obese, older adults remains controversial. Although caloric~     restriction, resulting in significant weight and fat mass loss, ameliorates many clinical~     consequences of obesity, recommendation of intentional weight loss in aging remains~     controversial. Reluctance stems, at least in part, from loss of lean and bone mass known to~     accompany overall weight loss and potential exacerbation of age-related risk of disability~     and fracture. Accordingly, current treatment guidelines call fhttp://google.wfu.edu/or~     weight-loss therapy that minimizes muscle and bone losses for older persons who are obese and~     who have functional impairments or medical complications that can benefit from weight loss.~      Amount of dietary protein consumed during caloric restriction may be a key determinant in~     maintaining fat-free mass during weight loss. Adequate dietary protein is essential for~     skeletal muscle anabolism; and, epidemiological evidence in older adults point to a salutary~     effect of protein intake above the current RDA (0.8 g/kg/day) on body composition. Indeed, a~     recent position statement by the PRO-TAGE study group advises consumption of 1.0-1.2 g/kg/d~     in older adults during weight-stable conditions to aid in the maintenance of lean body mass~     and function. Practical achievement of this level of protein intake is often difficult for~     obese, older adults undergoing weight loss, yet may be critical to offset weight~     loss-associated lean mass loss. Preliminary data from our group show a lean mass sparing~     effect of high protein consumption during caloric restriction. In post-menopausal women~     undergoing a 5-month intentional weight loss program, consumption of a high (1.2 g/kg/day)~     versus low (0.6 g/kg/day) protein diet was associated with 50% attenuation (17% vs. 37%) of~     lean mass loss. While promising, results have yet to be translated to functional changes in a~     tightly controlled trial of weight loss in obese, older adults.~      The primary goal of this study is to determine whether adherence to a high protein (≥1.0~     g/kg/d) weight loss program results in improved physical function by favorably affecting body~     composition compared to weight stability in obese, older adults. This will be accomplished by~     conducting a 24-week trial in 124 obese (BMI 30-40 kg/m2), older (65-79 years) men and women,~     at risk for mobility disability, randomized to either: (1) high protein intake (≥1.0 g/kg/d;~     n=62) during weight loss, or (2) weight-stable control (n=62).~   "
63867|NCT02730975|"~     ABIFOOD study is a randomized open-labelled, phase I study to evaluate food effect in the~     pharmacokinetic parameters of abiraterone acetate (AA) at reduced doses, versus AA in fasting~     conditions at conventional doses, in castration resistant prostate cancer (mCRPC) patients~     who have progressed to docetaxel.~   "
63868|NCT02730962|"~     The purpose of this study is to determine whether changing the microbial composition in the~     colon can improve metabolism of sugar in people who are on the verge of developing diabetes~     (pre-diabetics). Study participants will undergo a fecal microbiota transplantation (FMT)~     using material from lean donors, as well as a series of tests prior to and after the~     transplant. The investigators will examine any changes in fecal bacterial composition~     associated with FMT and determine if any observed changes have an influence on blood sugar~     metabolism.~   "
63869|NCT02730949|"~     The purpose of this pilot study was to evaluate the effect of D-chiro-Inositol (DCI) oral~     supplementation in addiction to folic acid compared to folic acid alone on glycaemic control~     as assessed by HbA1c in overweight or obese T1D patients undergoing intensive insulin~     therapy.~      A 24 weeks, prospective, randomized control trial was carried out in T1D patients, aged 17-50~     years (13 males, 13 females), with disease duration > 1 year and BMI >25, attending as~     outpatients the Endocrinology and Diabetes Unit of University Campus Bio-Medico in Rome~   "
63870|NCT02730936|"~     This prospective early feasibility clinical study will collect information regarding the~     safety and efficacy of the Cook® Antimicrobial Hernia Repair Device to reinforce soft tissue~     during ventral or incisional hernia repair in clean-contaminated and contaminated (i.e.,~     Class II and Class III) surgical fields.~   "
64443|NCT02723461|"~     Comparing continuous intravenous oxytocin infusion with pulsatile administration of~     intravenous oxytocin for augmentation of the first stage of labor.~   "
63871|NCT02730923|"~     The investigators hypothesize that the dual inhibition of mTORC1/mTORC2 by AZD2014 combined~     with inhibition of aromatase enzyme by anastrozole will act synergistically and may be an~     interesting therapeutic option for endometrial cancer with a manageable toxicity profile.~      The investigators proposal is to conduct a multicenter, 2-step, randomized, Phase I/II trial~     to evaluate the safety and efficacy of a combination treatment associating anastrozole to~     AZD2014 in advanced endometrial cancer patients.~      The study is divided in 2 steps :~        -  A safety run-in phase aiming to evaluate the safety of the proposed combination AZD2014~          + anastrozole (Arm A) versus anastrozole alone (Arm B). No dose escalation is scheduled~          (doses are based on maximum tolerated dose (MTD) defined for AZD2014 and the summary of~          product characteristics (SPC) of anastrozole). However, dose de-escalation for AZD2014~          will be applied in case of toxicity.~        -  A two-stage randomized Phase II part aiming to evaluate the clinical benefit of the~          AZD2014 + anastrozole (Arm A) combination therapy versus anastrozole (Arm B).~   "
63872|NCT02730910|"~     This study will determine the bioavailability of anthocyanins and phenolic compounds from two~     purple wheat products, i.e. bran-enriched wholegrain purple wheat crackers and bran-enriched~     wholegrain purple wheat granola bars. Crackers are an example of a baked/ processed product.~     The purple wheat granola bars are an example of a food product that requires much less~     intensive preparation and cooking, compared to the crackers. A comparison of bioavailability~     between these two products should provide insights about how different processes and food~     matrix influence anthocyanin bioavailability and metabolism.~   "
63873|NCT02730897|"~     Five papers showed a lower N1 nodal upstaging with video-assisted thoracic surgery (VATS)~     compared to open surgery in patients with cStage-I NSCLC . This finding questions the~     oncologic quality of minimal invasive lung cancer surgery, especially the quality of hilar~     and intrapulmonary lymh node dissection. However, these retrospective studies did not include~     analysis of central tumor location, although central tumors have a reported higher chance of~     N1 upstaging . Possibly, this creates a selection bias as surgeons might select central~     lesions deliberately for open surgery in line with initial VATS feasibility reports~   "
63874|NCT02730884|"~     The goal of this clinical research study is to learn if rigosertib can help to control MF in~     patients with anemia. The safety of this drug will also be studied.~      This is an investigational study. Rigosertib is not FDA-approved or commercially available.~     It is currently being used for research purposes only. The study doctor can explain how the~     study drug is designed to work.~      Up to 35 participants will be enrolled in this study. All will be enrolled at MD Anderson.~   "
63875|NCT02730871|"~     The purpose of this study is to evaluate the additive intraocular pressure (IOP) lowering~     effect of Brinzolamide 1%/Brimonidine 0.2% (SIMBRINZA®) dosed twice daily (BID) when added to~     Travoprost 0.004%/Timolol 0.5% (DUOTRAV®) in subjects with open-angle glaucoma or ocular~     hypertension.~   "
63876|NCT02730858|"~     The purpose of this research study is to test a new way to deliver oncology and palliative~     care for patients with metastatic breast cancer.~        -  The goal of this study is to test a model where oncology and palliative care work~          together to care for participants with metastatic breast cancer who were recently~          admitted to the hospital or have new or worsening cancer involving their brain or the~          fluid around the brain or spinal cord.~        -  The investigators are studying whether participants who receive care from both teams~          have better communication about their care and improved quality of life and mood~          compared to those receiving care from only their oncologists.~      The purpose of this randomized clinical trial is to conduct a randomized trial testing the~     impact of the collaborative palliative and oncology care model or standard oncology care~     models among patients with poor prognosis metastatic breast cancer. Participants assigned to~     the intervention arm will participate in a series of structured palliative care visits,~     following tailored clinical practice guidelines previously developed for patients with~     metastatic breast cancer.~   "
63877|NCT02730845|"~     The present study will be carried to evaluate the efficacy of intra-articular 0.5 bupivacaine~     with intra-articular or intravenous alpha-2agonist; Dexmedetomidine; for intraoperative~     anesthesia and postoperative analgesia after arthroscopic knee surgery.~      Arthroscopic knee surgery is one of the most common minimally invasive orthopedic procedures~     in recent practice which is frequently performed as a day surgery procedures. It can be done~     under general, regional or local anesthesia (LA) with or without sedation. It is associated~     with varying amount of postoperative pain. Postoperative pain negatively influences patient's~     early ambulation, rehabilitation and psychology which consecutively prolonged the hospital~     stay.~      Intra-articular administration of local anesthetic for knee arthroscopy is a well-documented~     procedure that offers many advantages over other anesthesia types. Many anesthesiologists are~     still trying to improve the technique of local anesthetic administration through using many~     combinations with LA solutions in order to administer safe anesthesia to those patients and~     to obtain a pain-free knee with good operating conditions.~      Dexmedetomidine is a highly selective α2 adrenergic agonist. It has analgesic, sedative,~     anxiolytic, hypnotic, sympatholytic, antihypertensive properties with anesthetic sparing~     effects. It becomes an attractive alternative to the current opioids because it does not have~     a respiratory depressant or addictive effect.~   "
63878|NCT02730832|"~     Apart from objective criteria for the evaluation of oral health (CAO, CPI…), there are no~     scales to evaluate the oral health of patients with schizophrenia. The only scales that do~     exist are for the population at large, children or the elderly. Given the severely~     deteriorated oral health in these schizophrenic populations, it is important to have a tool~     to evaluate their perception of the quality of their oral health so as to better orientate~     prevention programmes.~      The aim of this study is to validate a tool to measure the perception of oral health in~     patients with schizophrenia.~      To do this, patients will be invited to complete a series of self-questionnaires relative to~     the concept of oral health.~   "
63879|NCT02730819|"~     The purpose of this research study is to gather information on the effectiveness and~     tolerability of a novel composition of existing U.S. Food and Drug Administration (FDA)~     approved topical medications for the treatment of moderate to severe melasma.~   "
63880|NCT02730806|"~     The purpose of this interventional study is to evaluate the effectiveness of the NLP PTSD~     protocol in the event of PPPTSD in comparison with the common practice protocol. The study's~     main hypothesis is that the implementation of both protocols will be equally effective and~     result in reduction of the overall PTSD level.~   "
63883|NCT02730767|"~     Exercise can play a major role to mitigate or even prevent late effects in cancer survivors,~     such as cardiovascular disease, obesity, osteoporosis, fatigue, depression, reduced quality~     of life, mental health and physical performance.~      The objective of this study is to assess the effect of an exercise program of 1 year on~     cardiovascular health, obesity and diabetes, osteoporosis, physical fitness, mental health~     and quality of life in childhood cancer survivors. The investigators will recruit childhood~     cancer survivors aged 16 years and above from three Swiss paediatric oncology clinics and~     randomize them into an intervention and a control group. The intervention group will be asked~     to increase physical activity for 1 year by at least 2.5 hours of intense physical activity~     weekly. Regular feedback will be given via a step counter, an online activity diary, and by~     the centre staff. The control group participants will keep their activity level constant. All~     participants will be seen after 3, 6 and 12 months to assess health and quality of life~     parameters over one year. After 1 year, the control group is offered to receive the same~     intervention to profit as well from an active lifestyle.~      If the program shows to be effective, a complete package will become available to interested~     centres treating paediatric cancer patients in Switzerland to promote exercise in all~     survivors. The program will allow clinicians without previous experience in exercise~     counselling to improve the care of their patients.~   "
63884|NCT02730754|"~     This study aims to determine which factors are related to change in diabetes-related distress~     and change in depressive symptoms after three years of follow-up in Asian adults with type 2~     diabetes mellitus in primary care. The investigators will explore the impact of patient~     demographics, cardiometabolic control, medications adherence, health-related quality of life,~     self-efficacy and self-management behaviors on diabetes-related distress and depressive~     symptoms.~   "
63885|NCT02730741|"~     The mechanisms of diarrhoea under metformin are poorly known. Recent data indicate that a~     change in gut flora might be responsible for this intestinal disorder. The effect of~     metformin on the gut flora has been extensively described. It has been shown that the~     therapeutic effect of metformin depends on the microbiota. In agreement with these data, a~     recent publication has shown that metformin's main site of action in humans was the~     intestine. In light of these results, it now seems plausible that metformin's effect on the~     gut flora is responsible not only for its therapeutic effect but also for its undesirable~     digestive effects. In this respect, Lactobacillus rhamnosus has shown anti-diarrhoeal effects~     (approximately 50% reduction in diarrhoeas) in the contexts of infection-caused dysbiosis and~     post-antibiotic dysbiosis.~      Hypothesis: Taking into account the favourable effect on intestinal dysbiosis-induced~     diarrhoeas observed with Lactobacillus rhamnosus, we put forward the hypothesis that~     Lactobacillus rhamnosus Lcr35® will have a favourable effect on metformin-induced diarrhoea.~   "
63886|NCT02730728|"~     The purpose of this study is to compare a single shot block, 24 hours, and 48 hour continuous~     catheter nerve block done via the adductor canal method in adult patients who have under gone~     total knee arthroplasty. Visual analogue scores, opioid consumption, time to up and go,~     ambulation, manual muscle tests, and Tinetti scores up to 72 hours post operatively will be~     used for comparison.~   "
63887|NCT02730715|"~     This study aims to study the effects that two standard of care immunosuppression induction~     regimens have on regulatory T cells (Treg) in live donor renal transplant recipients. Both~     regimens are currently used in this hospital for early immunosuppression induction but the~     effects on Treg numbers and function is not well understood and likely will impact long term~     immune function.~   "
63888|NCT02730702|"~     This is a study whose focus is on understanding the clinical utility of rectal ultrastructure~     in detecting colonic neoplasm. The method uses Low-coherence Enhanced Backscattering~     Spectroscopy (LEBS).~   "
63889|NCT02730689|"~     The purpose of this study is to compare the pharmacokinetics of DP-R207 (Rosuvastatin 10mg~     and Ezetimibe 10mg fixed dose combinations) in comparison to each component administered~     alone in health male volunteers.~   "
63890|NCT02730676|"~     This study assesses the nicotine pharmacokinetic (PK) parameters in adopters of electronic~     cigarettes following a 12-hour tobacco and nicotine abstinence. The PK results of this study~     will be compared to historical data on smokers obtained in prior studies, as well as on naïve~     and short-term users of electronic cigarettes.~   "
63891|NCT02730663|"~     The purpose of this study is to evaluate the safety and effectiveness of endoscopic~     ultrasound (EUS)-guided transluminal drainage with 'Niti-S SPAXUS Stent' for the treatment of~     pancreatic pseudocyst.~   "
63892|NCT02730650|"~     This study will be a prospective study of patients who undergo platelet-rich therapy (PRT)~     for facial rejuvenation at NYU Langone Medical Center. PRT has been increasingly used for~     wound healing, fat grafting, hemostasis as well as facial enhancement. PRT involves injection~     of patient's own platelets and fibrin, and has evolved as a less invasive technique for~     facial rejuvenation compared to more traditional techniques. Through the use of pre and post~     treatment photos, in addition to the FACE-Q Questionnaire and a clinician assessment, it is~     our hope that we will confirm the rejuvenating capabilities of PRT.~   "
63893|NCT02730637|"~     This study examines the clinical relevance of early biomarkers to detect and prevent acute~     kidney injury. High-risk patients for developing acute kidney injury will be screened at~     initial presentation (emergency department and intensive care unit) for TIMP2xIGFBP7. In case~     of elevated readings patients will be randomized in two arms: The control group will be~     treated with standard care, the intervention group will receive an early nephrologic~     consultation.~   "
63894|NCT02730624|"~     This is prospective study to assess the pharmacodynamics (t>MIC) of 4.5 g every 6 h of~     piperacillin/tazobactam in patients with early phase of severe sepsis/septic shock following~     administration by a 30 min infusion.~      Clinical and laboratory data such as age, sex, body weight, electrolyte, vital signs, APACHAE~     II score, BUN, Cr and fluid balance will be collected.~      Fifty patients will be enrolled in this study. Piperacillin pharmacokinetic study will be~     carried out during the piperacillin/tazobactam therapy.~      Each patient received 4.5 g every 6 h of piperacillin/tazobactam within 24 h of severe sepsis~     or septic shock, blood samples (approximately 3 ml) will be obtained by direct venipuncture~     at the following time: 0, 0-0.5, 0.5-2, 2-4 and 4-6 h after piperacillin/tazobactam therapy.~      Concentration of piperacillin in plasma will be simulated in Monte Carlo technique to get~     PK/PD index and reported to % PTA and % CFR.~   "
63895|NCT02730611|"~     Increasing rates of highly malignant hepatocellular carcinoma (HCC) and biliary tract cancers~     (GBTC) observed in Western populations may be related to obesogenic lifestyle factors and~     their metabolic consequences, such as metabolic syndrome (MetS), inflammation and altered~     production of bile acids (BA). Such lifestyle behaviours may induce changes in the gut~     microflora which in turn affect BA profiles, increasing their carcinogenicity. Some elevated~     BA may be oncogenic in exposed liver, bile ducts and gall bladder. Vertical sleeve~     gastrectomy may change bile acid composition.~      The aims of this study are:~        1. whether specific presurgical bila acid profiles are predictive of efficacy of vertical~          sleeve gastrectomy, reflective of liver function and metabolic dysfunction;~        2. whether specific presurgical bile acid profiles are predictive of the efficacy of sleeve~          gastrectomy~   "
63896|NCT02730598|"~     Osteoarthritis of the knee (KOA) is the most common cause of disability in older adults.~     Osteoarthritis involves a loss of cartilage, which acts like a cushion between the bones as~     well as changes in the bones of joints. Once the joint cartilage is gone, the body does not~     produce new cartilage. Joint damage can contribute to pain. Currently, treatment for pain~     associated with knee osteoarthritis includes exercise. However, exercise at a medium- to~     high-intensity level can be problematic for people with knee pain. Because exercise is a~     common treatment for knee pain but many people experience pain during exercise, researchers~     hope to find a safer and more effective exercise method to strengthen the muscles around the~     knee.~      Both aerobic exercise and resistance exercise are recommended for the treatment of people~     with knee pain. However, pain can be a barrier to participating in exercise at a moderate or~     vigorous intensity. Electrical stimulation of muscles holds potential to allow effective~     exercise to be completed at tolerable intensities. Transcutaneous electrical nerve~     stimulation (TENS) is the use of very low electric currents produced by a device to stimulate~     the nerves, to treat pain. Neuromuscular electrical stimulation (NMES) uses low electrical~     current to cause muscles to contract.~      By doing this study, the investigators hope to learn if a hybrid training system (HTS), using~     a combination of NMES and walking, is effective in strengthening muscles in people with knee~     pain, aching or stiffness.~      In this pilot study, the investigators will use walking with TENS as conventional exercise.~      Randomized controlled trial will be conducted to compare the effect of walking augmented by~     HTS with walking without HTS. The investigators will evaluate the relative advantages of~     training that combines HTS with conventional walking exercise on the improvement of muscle~     strength, physical function, and pain relief in obese women with frequent knee symptoms.~      Study Hypotheses: Compared with walking with sensory TENS, walking with HTS will:~        -  1 increase quadriceps muscle strength.~        -  2 decrease knee pain.~      Exploratory Hypotheses:~        -  3 improve physical function.~        -  4 increase PPT (improve central sensitization).~        -  5 improve self-reported quality of life.~   "
63897|NCT02730585|"~     The diagnosis of acute appendicitis is difficult and despite important advances in medical~     sciences, detailed patient questioning and precise medical examination are the main keystones~     of the diagnosis of acute appendicitis and up to now, results still unsatisfactory.~   "
63898|NCT02730572|"~     The primary purpose of this study is to identify whether, after adjustment for confounders~     via stratification on a propensity score and adjustment for calendar year, the combined~     endpoint consisting of #1 to #4 (1. switching back to Concerta, 2. changing the use of~     immediate release [IR] methylphenidate, 3. beginning a new attention deficit hyperactivity~     disorder [ADHD] medication, or 4. stopping both Concerta and the long acting [LA]~     methylphenidate {authorized generic [AG] methylphenidate or equivalent generic [EG]~     methylphenidate} that was begun on the index date), differs between participants who switch~     from branded Concerta to the EG formulations versus participants who switch from branded~     Concerta to the AG formulation.~   "
63899|NCT02730559|"~     The primary focus of this proposal is to address growing concern of overweight/ obese~     adolescents with hyperlipidemia. The proposed study is a 2-arm randomized controlled clinical~     trial to compare the effectiveness of Motivational interviewing (MI) interventions with the~     parent and adolescent dyad versus adolescent (10-17yr) alone. The patients will be recruited~     from the Lipid clinic at Sick Kids. The study hypothesis is that parent child dyad will have~     more success due to the possible synergetic effect compared to adolescents alone. The study's~     primary outcome is cholesterol levels (Triglycerides/HDL ratio) and secondary outcomes~     include overall improvement in their lifestyle and their responses to the MI intervention.~   "
63900|NCT02730546|"~     This phase Ib/II trial studies the side effects and best way to give pembrolizumab with~     combination chemotherapy and radiation therapy before surgery and to see how well it works in~     treating adult patients with gastroesophageal junction or gastric cardia cancer that has~     spread from where it started to nearby tissue and can be removed by surgery. Monoclonal~     antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting~     certain cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.~     Giving pembrolizumab, combination chemotherapy, and radiation therapy before surgery may make~     the tumor smaller and reduce the amount of normal tissue that needs to be removed.~   "
63901|NCT02730533|"~     This will be a single-centre, randomised, endoscopist-blind, parallel-group study in patients~     who are scheduled endoscopic submucosal dissection (ESD) for gastric mucosal lesion. The~     primary objective is to observe whether a regimen of 7-day oral esomeprazole premedication~     can alleviate intraoperative bleeding in patients scheduled for ESD due to gastric mucosal~     lesions.~   "
63902|NCT02730520|"~     Worldwide, respiratory diseases have a significant impact on morbidity and mortality of~     individuals.Tobacco, lifestyle and certain allergens such as dust mites play an important~     role in the prevalence and morbidity of these diseases. Scientific literature indicates that~     sensitization to allergens and respiratory diseases (asthma, rhinitis, chronic obstructive~     pulmonary disease) are closely linked. Moreover, smoking has an effect on allergen~     sensitivity.~      To make a diagnosis of allergic sensitization, skin tests are performed in the patient. One~     of the methods used is the technique of prick test. In practice, a drop of purified~     allergen extract is placed on the patient's skin (arms or back). A little dosis of the~     product is then injected in the epidermis. If fifteen minutes later, there is an edematous~     reaction, its diameter is measured in millimeters. From 4 mm, it is considered that the~     patient is sensitized to the tested foods or allergens.This technique is painless and~     convenient to patients of all ages, including newborns or conversely very aged patients.~      This is a retrospective study based on the encoding and statistical analysis of data~     collected in patients followed within the Immuno-Allergology Service of the CHU Brugmann~     Hospital, who received an allergy assessment between 01/01/2015 and 31/12/2015. The allergens~     tested include: dermatophagoides pteronyssinus (DEPT), dermatophagoides farinae (DPF),~     blomia, cat, dog, cockroach, orchardgrass, timothy grass, alder, hazel,birch, olive tree,~     cypress, ash, latex, aspergillus, alternaria, cladosporium, peanut, hazel.~      At least 1400 files will be analyzed.~      Patients will be distributed in six age groups.The results of the allergen skin tests will be~     encoded as the edema diameter. The allergenicity score (mean of the skin reactivities for~     each allergen) will be compared between each age groups. The impact of tabagism, gender, BMI~     and residential area on the allergic reactivity will also be assessed in the overall~     population and within each age group.~      The main objective is to evaluate the effect of age on the skin test positivity. The~     secondary objective is to highlight the environmental factors that have an impact on allergic~     diseases.~   "
65182|NCT02713789|"~     To evaluate the safety and efficacy of a single intracavernous injection of hMaxi K (8000 µg~     and 16000 µg) or placebo upon penile rigidity or erection in males with erectile dysfunction~     longer than six months that is attributable to an underlying, stable medical condition.~   "
63903|NCT02730507|"~     Lumbar degenerative diseases (LDD) are an increasingly common condition affecting millions of~     patients worldwide. LDD can impact not only function, but can also become markedly disabling~     and cause severe chronic pain. Recent studies support the idea that analysis of sagittal~     balance is a crucial keypoint to optimize the management of lumbar degenerative diseases,~     especially when spinal instrumentation is intended.~      The first treatment of these pathologies is a medical treatment (medications, physical~     therapy and exercise). Surgical treatment is frequently necessary if the symptoms worsen and~     is generally a posterior spinal fusion with instrumentation (screws, hooks and rods) and bone~     graft. Basic principle of the surgery is to realign the spine along the rod.~      Despite documented techniques for surgical planning, it appears that a significant number of~     patients are ultimately under-corrected after surgery Realignment failure has not only been~     associated with poor functional outcome but also major complications, such as pseudoarthrosis~     and rod breakage, which often results in additional surgical procedures.~      From a pragmatic point of view, there are two main reasons for realignment failure: poor~     surgical planning and poor execution. One of the assumptions is that perioperative manual~     bending of the rod may not always allow the surgeon to restore the sagittal parameters as~     intended.~      A new concept of patient-specific rod (PSR) is now being proposed by a French manufacturer in~     order to enable an optimal correction and surgical stabilization of the spine. PSR are~     designed to fit with the patient's unique sagittal spine profile and with surgeons' surgical~     planning. However, no relevant clinical data is currently available to support the expected~     medical benefit of this new technology.~      The objective of the study is therefore to carry out a study hypothesizing that the use of~     PSR could improve the percentage of patients whose sagittal profile is optimally corrected~     after spinal surgery, as well as the patient's quality of life.~   "
63904|NCT02730494|"~     The primary objective of this study is to study the vaginal flora colonisation equivalence~     between the tablet and capsule dosage forms of a treatment with Lcr Regenerans® between D0~     (V1) and Dend of treatment.~   "
63905|NCT02730481|"~     This is a multicenter, open-label, safety study. Eligible subjects will be adults with~     advanced malignancies. The study includes a pretreatment and treatment phase. The~     pretreatment phase consists of screening and baseline periods. The treatment phase consists~     of 4-week treatment periods and a follow-up period.~   "
63906|NCT02730468|"~     The purpose of this study is to evaluate the performance of the Karius Infectious Diseases~     Plasma Sequencing Assay in patients who present to the emergency room with sepsis.~   "
63907|NCT02730455|"~     The primary objective of the study is to assess the clinical effects of natalizumab versus~     placebo in acute ischemic stroke on clinical measures of functional independence and~     activities of daily living. The secondary objective of the study is to explore dose and~     exposure response and the clinical treatment effects of natalizumab versus placebo in acute~     ischemic stroke on the following: measures of independence, activities of daily living,~     neurologic function, quality of life, cognition, and safety and tolerability~   "
63908|NCT02730442|"~     This will be an open label study in two parts. In the first part, F901318 (dose 2 mg/kg IV~     over 4 hours, Day 1) will be followed by F901318 (2 mg/kg IV over 4 hours) given on Day 8,~     after dosing with fluconazole 800 mg daily for 1 day (Day 4) and 400 mg daily orally for 4~     days (Days 5 to 8). Up to twenty subjects will be included in two cohorts which will undergo~     the same dosing schedules of fluconazole and F901318 and undergo the same procedures. The~     first cohort will consist of 12 subjects studied in two groups of six subjects each. If there~     is clearly a difference in F901318 kinetics detectable before and after dosing with~     fluconazole in this first cohort, the second cohort will not be studied. If there is no clear~     difference, the second cohort will also be studied to give a final result. In this cohort,~     based on the pharmacokinetic findings in cohort 1, the dose of F901318 may be increased to up~     to 4 mg/kg to establish a dose suitable for phase 2 evaluation. PK sampling for plasma~     F901318 will continue from before the first dose up to and including 72 hours after dosing.~     PK sampling for fluconazole will continue from before the first dose and up to 72 hours after~     the fifth dose. A follow up visit will be conducted 7 +/- 2 days after discharge from the~     clinical unit following completion of blood sampling following the second dose of F901318 and~     the fifth dose of fluconazole.~      The second part of the study will take place if no appreciable change in the pharmacokinetics~     of either F901318 or fluconazole has been observed in either the first or the second cohorts~     in the first part of the study. This second part will enrol 12 subjects. These subjects will~     receive fluconazole 800 mg daily for one day (Day 1) and 400 mg daily orally for 4 days (Days~     2 to 5) in combination with F901318 which will be given in a dose of up to 4 mg/kg IV bid for~     one day (Day 1) followed by 7 doses of intravenous F901318 up to 2.5 mg/kg bid (Days 2 to 5).~     Pharmacokinetic profiles of F901318 and fluconazole will be obtained during dosing and over a~     72-hour period following the final dose of both compounds.~   "
63909|NCT02730429|"~     This randomized double-blind, placebo-controlled phase 2 trial is evaluating superiority of~     Letrozole-palbociclib combination versus letrozole-placebo combination in ER positive~     endometrioid adenocarcinoma of endometrium~   "
63910|NCT02730416|"~     This study will evaluate the role of addition of an anti-angiogenic agent~     (Nintedanib/placebo) to conventional combination chemotherapy as concomitant and maintenance~     treatment in primary advanced or with first relapse of endometrial cancer.~   "
63911|NCT02730403|"~     This is an observational, ancillary study intended to describe opioid use among opioid use~     disorder patients following their discharge into the community from inpatient detoxification~     and/or short-term residential treatment programs affiliated with parent study CTN-0051, which~     assessed the comparative effectiveness of extended release injectable naltrexone (XR-NTX,~     Vivitrol®), an opioid antagonist recently approved and indicated for the prevention of~     relapse to opioid dependence, versus buprenorphine-naloxone (BUP-NX, Suboxone®), a high~     affinity partial agonist indicated for maintenance treatment of opioid dependence, as~     pharmacotherapeutic aids to recovery.~   "
63912|NCT02730390|"~     The primary objective of this post marketing surveillance (PMS) is to determine the safety~     and efficacy of probucol in lowering the level of serum cholesterol in the blood.~   "
63913|NCT02730377|"~     This trial is conducted globally. The aim of the trial is to investigate efficacy in~     controlling glycaemia with Victoza® (liraglutide) as add-on to metformin background treatment~     vs. OADs as add-on to metformin background treatment for 104 weeks of treatment in subjects~     with type 2 diabetes.~   "
63914|NCT02730364|"~     The purpose of the study is to assess the short term efficacy of the Theraflu Night powder~     for oral solution in the Russian population in Short term relief of the symptoms of colds,~     chills and influenza, including mild to moderate pain, fever and nasal congestion.~   "
63925|NCT02730221|"~     A prospective observational study in the Intensive Care Unit and the Medium Care Unit in a~     university hospital in Amsterdam. Recent studies show that administrative tasks occupy more~     than 30% of the workload. One-third of these administrative tasks is unrelated to care. The~     administrative workload of physicians and nurses will be observed and quantified using two~     different methods. The amount of time physicians and nurses are logged on into the patient~     data management system (PDMS) will be measured and the time spent on different work tasks~     will be monitored with a work sampling method. Two different patient data management systems~     will be compared.~   "
63926|NCT02730208|"~     The primary purpose of study is to evaluate the treatment effect of VX-661 in combination~     with ivacaftor (VX-661/ivacaftor) on chest imaging endpoints using low-dose computed~     tomography (LDCT) at Week 72, and to evaluate the safety of VX-661/ivacaftor through Week 72~   "
67470|NCT02683811|"~     This study evaluates the short- and long-term effects on psychological wellbeing and~     health-related behaviours of the updated version of a universal school-based program called~     Diario della Salute (DDS-2) in Italian students aged 11-13 years.~   "
63915|NCT02730351|"~     This is a multicenter, randomized, double-blind, double-dummy, crossover study with two~     2-week treatment periods separated by a 2-week wash-out period. Subjects will participate in~     up to eight study visits and have a follow up phone call approximately a week after the last~     clinic visit. Visits 1, 2, 3, 5 and 6 are evening visits that will be conducted between 5PM~     and 11PM. Visit 4 and Visit 7 are also evening visits that will begin between 5PM and 11PM~     and continue over a period of approximately 24 hours. Subjects will be required to attend~     three clinic visits during this 24-hour period. An exercise challenge (using a treadmill)~     will be conducted at Visit 2, Visit 3 and Visit 6 (after 23 hours of the first treatment dose~     in each Treatment Period); and at 12 and 23 hours post evening dose at Visits 4 and 7.~     Spirometry will be conducted at specified visits and prior to and after each exercise~     challenge.~      Subjects with symptomatic allergic rhinitis at Visit 1 (screening) may be treated for up to~     four weeks with intranasal corticosteroids followed by a repeat screening visit to determine~     eligibility prior to entry into the study.~      Eligible subjects at visit 1 will complete a 4-week single blind run-in on FP 250 microgram~     (mcg) twice daily (BID), followed by 2-week double-blind Treatment Period 1 on randomized~     treatment, a 2-week single blind washout period on FP 250 mcg BID, 2-week double-blind~     Treatment Period 2 receiving the alternative treatment, and follow-up contact approximately~     7-days after completing Treatment Period 2. The total duration of study participation is~     approximately 11 weeks; and up to 15 weeks for subjects with Symptomatic Allergic Rhinitis.~      The primary objective of the study is to evaluate the protective effect of fluticasone~     furoate/vilanterol (FF/VI) 100/25 mcg once-daily compared with fluticasone propionate (FP)~     250 mcg twice-daily against exercise-induced bronchoconstriction in adolescent and adult~     subjects aged 12 to 50 with persistent asthma.~      ELLIPTA, ACCUHALER, and DISKUS are registered trademarks of the GlaxoSmithKline group of~     companies.~   "
63916|NCT02730338|"~     A Study to determine if high intensity aerobic and resistance training plus psychosocial~     support increases overall survival compared to psychosocial support alone in patients with~     metastatic castrate-resistant prostate cancer.~   "
63917|NCT02730325|"~     The effects of serum-derived bovine immunoglobulin/protein isolate (SBI) will be evaluated~     and compared to matching placebo in two distinct patient populations:~      I. Hospitalized ulcerative colitis (UC) patients who tested positive for Clostridium~     difficile (C. difficile) at time of admission and are receiving vancomycin.~      II. Hospitalized UC patients who tested negative for C. difficile at time of admission.~   "
63918|NCT02730312|"~     The purpose of this study is to determine the safety and tolerability of weekly intravenous~     (IV) administration of XmAb14045 and to determine the maximally tolerated dose (MTD) after~     the first dose, and then to determine the MTD after second and subsequent infusions.~   "
63919|NCT02730299|"~     This study is an open-label, controlled, multicenter, international, Phase III, randomized~     study of transplantation of NiCord® versus transplantation of one or two unmanipulated,~     unrelated cord blood units in patients with acute lymphoblastic leukemia or acute myeloid~     leukemia, myelodysplastic syndrome, chronic myeloid leukemia or lymphoma, all with required~     disease features rendering them eligible for allogeneic transplantation.~   "
63920|NCT02730286|"~     Objective: To evaluate what factors contribute to activity limitations in subjects with~     rheumatoid arthritis considering the International Classification of Functioning, Disability~     and Health model.~      Methods: A cross-sectional study on 81 individuals with rheumatoid arthritis (RA) using~     instruments to measure five constructs of the component activities.~   "
63921|NCT02730273|"~     This investigation is designed to evaluate the performance (leak and comfort) as well as the~     participant's overall acceptance of the trial nasal mask amongst Obstructive Sleep Apnea~     (OSA) participants. An important factor in this investigation will be the testing of two~     different seal sizes on the participants (medium and large size). A total number of 12~     participants who currently use nasal or nasal pillow masks will be recruited for the trial.~     Participants have been selected based on their anthropometric measurements collected in~     previous trials (CIA-103). Participants from previous NZ trials may be recruited into this~     trial with their consent. All the participants will be recruited from the Fisher & Paykel~     Healthcare Database of subjects with OSA (Ethics Reference NTY/08/06/064), Auckland District~     Health Board (ADHB) and New Zealand Respiratory and Sleep Institute (NZRSI).~      Participants will use the trial mask in home for a period of 7 ± 3 days and also 1 overnight~     polysomnography session at the Fisher & Paykel Healthcare sleep lab. Baseline data will be~     collected from the participant during the first visit, 7 days of CPAP usage data will be~     downloaded and stored for analysis. The participant will use the trial device on their usual~     Continuous or Auto Positive Airway Pressure (CPAP/APAP) setting and device for the duration~     of the trial.~   "
63922|NCT02730260|"~     Social support is poorly understood but likely to influence outcomes of behavior change~     efforts. Social support may take a directive or nondirective approach. In directive support,~     the person attempting a behavior change is told what to do and even what to think. In~     nondirective support, the person attempting the behavior change decides what to discuss. In~     some contexts, interactions of race or income with social support have been reported. This is~     a randomized controlled trial of directive and nondirective coaching in the context of a~     smoking quitline offered to employees of two large corporations.~   "
63923|NCT02730247|"~     The subjects who take part in this clinical research study have advanced non-small cell lung~     cancer (NSCLC) that has been previously treated with other drugs. If they join this study,~     they would receive ramucirumab (Cyramza ®) in combination with nab-paclitaxel (Abraxane®).~     Ramucirumab given with nab-paclitaxel is considered an investigational drug combination to~     use in this type of cancer because giving these two drugs together has not been approved by~     any regulatory authority like the US Food and Drug Administration (FDA) for NSCLC cancer.~     Ramucirumab works by slowing or stopping the growth of cancer cells. Nab-Paclitaxel works by~     blocking the ability of cancer cells to break down the internal 'skeleton' that allows them~     to divide and multiply. With the skeleton still in place, the cells cannot divide and they~     eventually die.~   "
63924|NCT02730234|"~     The purpose of this study is to test the hypothesis that Jetstream atherectomy (JS) and~     adjunctive balloon angioplasty (PTA) (JS +PTA) improves target lesion revascularization (TLR)~     at 6 months follow-up when compared to historic data from PTA alone in the treatment of~     femoropopliteal (FP) arterial In-stent restenotic (ISR) disease.~      This is a prospective, multicenter, single arm study evaluating the investigational use of~     Jetstream Atherectomy (JS) and adjunctive balloon angioplasty (JS +PTA) in the treatment of~     FP ISR lesions in subjects with claudication or limb ischemia (Rutherford clinical category~     (RCC) of 2-4) (lesion length ≥ 4 cm). The comparator arm is historic data from plain old~     balloon angioplasty derived from a Meta-analysis of the 3 published randomized trials in the~     field.~   "
63967|NCT02729675|"~     The purpose of this project is to study the efficacy of a delivery system to offer fresh~     fruits and vegetables (F&V) at discount prices for purchase at worksites in conjunction with~     educational interventions on increasing employees' F&V consumption in comparison to an~     intervention receiving fruit and vegetable markets alone or a comparison intervention.~   "
63927|NCT02730195|"~     This phase II trial studies how well pioglitazone hydrochloride and tyrosine kinase inhibitor~     (TKI) therapy works in treating patients with chronic myeloid leukemia (CML) that has come~     back after a period of improvement (relapsed) after a first TKI discontinuation. TKI may stop~     the growth of cancer cells by blocking certain enzymes need for cell growth. Although TKI~     therapies are effective against CML, there are residual cancer cells called leukemia stem~     cells that are able to hide from TKIs. Pioglitazone is a drug approved by the Food and Drug~     Administration to treat diabetes and has been shown in laboratory studies to increase CML~     stem cell death when given together with TKI therapy. Giving pioglitazone with TKI therapy~     may be effective in treating patients with CML.~   "
63928|NCT02730182|"~     Prospective interventional trial in lowlanders evaluating the effect of acute exposure,~     acclimatization and re-exposure to high altitude on postural control~   "
63929|NCT02730169|"~     The purpose of this study is to evaluate the safety and efficacy of BGS649 in male obese~     subjects with hypogonadotropic hypogonadism. All subjects will be treated for a maximum of 24~     weeks. Some subjects who complete 24 weeks of treatment will be invited to participate in a~     6-month blinded safety extension study (Protocol MBGS206). The study is planned to enroll 268~     subjects.~   "
63930|NCT02730156|"~     Prospective interventional trial in lowlanders evaluating effect of acute exposure,~     acclimatization and re-exposure to high altitude~   "
63931|NCT02730143|"~     Prospective interventional trial in lowlanders evaluating the effect of acute exposure,~     acclimatization and re-exposure of high altitude on nocturnal breathing pattern.~   "
63932|NCT02730130|"~     The purpose of this study is to find out what effects, good and/or bad, pembrolizumab has on~     the patient and areas of cancer in their body that did not receive radiation therapy.~   "
63933|NCT02730117|"~     Does Early Initiation of Renal Replacement Therapy Have an Impact on 7-day Fluid Balance in~     Critically Ill Patients with Acute Kidney Injury with Positive Furosemide Stress Test?: a~     Multicenter Randomized Controlled Trial~   "
63934|NCT02730104|"~     The purpose of this trial is to assess time to disease progression of patients with locally~     advanced or metastatic gastroenteropancreatic neuroendocrine tumors treated with Lanreotide~     Depot. This is an observational study therefore all data collected will be in accordance with~     the routine practice of physicians.~   "
63935|NCT02730091|"~     This study is designed to evaluate the clinical effects of the addition of metronomic oral~     vinorelbine to letrozole and anastrozole. The study will compare the efficacy and~     tolerability of oral metronomic vinorelbine administered in combination with letrozole or~     anastrozole, as treatment for hormone receptor-positive advanced or metastatic breast cancer~     without resistance to Aromatase Inhibitors (AI).~   "
63936|NCT02730078|"~     The purpose of the clinical trial is to evaluate the effectiveness of a relatively simple and~     short value-based emotion-focused educational programme in adults with type 2 diabetes~     (VEMOFIT) on diabetes-related distress, depressive symptoms, illness perception, medication~     adherence, quality of life, diabetes self-efficacy, self-care and clinical outcomes.~   "
63937|NCT02730065|"~     Introduction: Cerebral small vessel disease (SVD) is associated with age-related disabilities~     including dementia, depression, physical and functional impairment. Chinese are more prone to~     developing SVD than Caucasians. Physical exercise may improve multiple negative consequences~     associated with SVD.~      Objective and hypothesis to be tested: To examine the effects of a 24-week structured aerobic~     dance training on cognition, mood, physical and daily functions in stroke and dementia free~     older adults with SVD, and whether such effects are mediated through improved cerebral~     vasomotor reactivity (CVR), a marker of cerebral autoregulation which is impaired in SVD.~      Design and subjects: Rater-blind RCT comparing the effects of 24-week of structured aerobic~     dance training upon cognition, mood, physical and daily functions on 110 community dwelling,~     stroke- and dementia-free persons aged ≥65 with MRI evidence of significant SVD, defined as~     the presence of multiple (≥2) lacunes and/or early confluent or confluent WML.~      Interventions: Participants are randomized in a 1:1 ratio into a 24-week of structured~     therapist-led group aerobic dance training with home practice or simple stretching plus~     health education control group.~      Main outcome measures: Cognition, mood, physical and daily functions and CVR measured using~     Transcranial Doppler at baseline, weeks 12, 24 and 36.~      Data analysis: Intent-to-treat with multiple imputations with treatment efficacy analyzed~     using mixed effects models. Mediation effects of CVR between aerobic dance training and~     treatment outcomes tested using mediation models.~      Expected results: In persons with significant SVD, aerobic dance training improves cognitive,~     mood, physical and daily functions and such effects are mediated by changes in CVR.~   "
63938|NCT02730052|"~     The proportion of hypertensive patients achieving adequate blood pressure control meeting~     guideline targets remains low. Of those patients on blood pressure lowering drugs, only 50%~     reach control.~      Objectives:~        1. Test the feasibility of telemonitoring of blood pressure in uncontrolled hypertensive~          patients.~        2. Investigate whether telemonitoring enabled self-measurement of blood pressure leads to~          faster blood pressure control than self-measurement without telemonitoring.~        3. Secondary endpoints include adverse effects, assessment of quality of life, adherence, a~          log of technical problems, and cost-effectiveness.~      Methods:~      Randomised parallel-group study consisting of 4 stages.~        -  Screening to check for eligibility.~        -  Randomisation in a 1:1 proportion to control or experimental arm: In the control arm,~          doctors will receive reports on the self-measured blood pressure based on diary cards;~          in the experimental group, doctors will receive weekly reports via telemonitoring.~        -  Treatment period: Doctors will adjust treatment according to the present guidelines of~          Hypertension. Blood pressure control is a home blood pressure below 135 mm Hg systolic~          and 85 mm Hg diastolic. Once blood pressure control is achieved the treatment period~          ends.~        -  Late follow-up: Assessment of blood pressure control at home 3 months after completion~          of the treatment period by means of telemonitoring.~      Sample size: 120 patients per group. Patients: recruited at clinics from Uruguay and~     Argentina.~      Main Inclusion Criteria:~        -  Women and men, age range 20 to 80 years.~        -  Uncontrolled hypertension and new diagnosed hypertension with a self-measured blood~          pressure at home of 135 mm Hg systolic and/or 85 mm Hg diastolic or more;~        -  Patients should be willing to accept adherence checking during follow-up and sign an~          informed written consent.~      Exclusion Criteria~        -  Patients emotionally or intellectually not capable of measuring their blood pressure at~          home;~        -  A clinical or social context, which is suboptimal for the self-measurement of blood~          pressure;~        -  Pregnancy;~        -  Alcohol or substance abuse or psychiatric illnesses;~        -  Participation in another study. Expected outcomes: blood pressure control will be~          achieved faster in the telemonitoring group.~   "
63939|NCT02730039|"~     The purpose of this project, entitled Meaning-Centered Psychotherapy Training for Cancer~     Care Providers, is to develop a multi-modal training program in Meaning-Centered~     Psychotherapy (MCP) for multidisciplinary cancer care clinicians who provide psycho-oncology~     and psychosocial palliative care services for cancer patients.~   "
66875|NCT02691611|"~     The investigators hypothesize that environmentally influenced histone modifications regulate~     AM mediated inflammation, contributing to a variable clinical course of AATD, and may also~     influence or be influenced by the activity of AAT augmentation therapy.~   "
63940|NCT02730026|"~     The control of pain, swelling and trismus in patients undergoing oral and maxillofacial~     surgery is frequently performed through the administration of non-steroidal anti-inflammatory~     drugs (NSAIDS). The present study aims to evaluate in a double blind, randomized and~     crossover manner the clinical efficacy of ketoprofen (immediate release - 100 mg) and~     ketoprofen in association with omeprazole (modified release - 200 mg ketoprofen with 20 mg~     omeprazole) in 50 patients aged 18 years or older that require removal of both lower third~     molars symmetrically positioned. After collection, data will be analyzed by means of graphs~     and tables to allow the appropriate analyses. Paired t-test will be used to compare the~     duration of surgeries. Nonparametric Wilcoxon test will be used for the analysis of rescue~     medication and postoperative pain parameters (visual analog scale). Data of mouth opening~     and swelling will be statistically analyzed through analysis of variance (ANOVA) followed~     by Tukey's test for multiple comparisons. Statistical significance will be set at 5%. Results~     will be presented as mean ± standard deviation of the mean.~   "
63941|NCT02730013|"~     This is a 3 month cluster randomized controlled trial using a square-stepping exercise~     program (a.k.a. mind-motor exercise) in retirement and long-term care residences to improve~     global cognitive functioning in older adults with and without cognitive impairments. The~     investigators intend this project to be pragmatic and therefore will include residents with~     dementia and walking aids if the participants wish to participate. The primary outcome is~     global cognitive functioning, secondary outcomes include: single and dual task gait (only~     completed with those without dementia), oculomotor functioning, and functional fitness. The~     investigators hypothesize that there will be improvements in primary and secondary outcomes~     in the intervention group.~   "
63942|NCT02730000|"~     Given the clinical damage caused by errors commonly made during the dosage and handling of~     glass ionomer cement (GIC) of high viscosity powder-liquid type, the use of encapsulated~     ionomer has been recommended for final restorations. However, the initial cost of the~     encapsulated MIC is higher when compared to the material handled manually. The objective of~     this randomized study is to (1) reveal cost-effective in the long run, the encapsulated CIV~     Riva Self Cure and Equia used as a restorative material in atraumatic restorations~     (Atraumatic Restorative Treatment), (2) assess whether the type of cavity (occlusal and~     occlusal-proximal) influences the longevity of atraumatic restorations using encapsulated IC,~     (3) assess whether the child's caries experience influences the longevity of atraumatic~     restorations with GIC encapsulated. Children, ages 3 and 7, will be selected in the Tietê-SP~     municipality. Randomization will be performed in a stratified manner by the conditions: type~     of cavity and caries experience. 122 ART restorations are performed using encapsulated CIV -~     Riva Self Cure - SDI and Equia -CG Corp. The restorations will be evaluated after 6, 12 and~     18 months by two trained examiners blind to the groups (intra- and inter-rater agreement~     above 0.7). To verify the survival of the restorations will be used Kaplan-Meier survival~     analysis and log-rank test. To evaluate the association between longevity and variable Cox~     regression test will be applied. For the cost analysis will be used analysis of variance.~   "
63943|NCT02729987|"~     The purpose of this pilot study is to explore the effect of an online facilitated discussion~     group on engagement with a stress management intervention delivered to employees in the UK~     via the Internet. The investigators primary hypothesis is that the intervention group with~     access to an online facilitated discussion group (delivered via a message board) will show~     greater engagement than the intervention group that does not have access to the discussion~     group. The investigators also hypothesise that participants in the intervention groups will~     improve significantly on psychological distress and subjective wellbeing measures compared to~     the waiting list control group, and that the group with access to the online facilitated~     discussion group will show the greatest improvement.~   "
63944|NCT02729974|"~     This study evaluates the use of rapid tests for hematocrit and clotting function in women~     undergoing surgery for placenta accreta. Half of participants will have these rapid tests~     performed during surgery to guide blood product transfusion and the other half will have~     standard lab tests performed to guide transfusion.~   "
63945|NCT02729961|"~     This phase I/II trial studies the side effects and best dose of ceritinib when given together~     with brentuximab vedotin to see how well they work in treating treatment-naive patients with~     anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma. Ceritinib may stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal~     antibodies, such as brentuximab vedotin, may interfere with the ability of tumor cells to~     grow and spread. Giving ceritinib together with brentuximab vedotin may be a better treatment~     for ALK-positive anaplastic large cell lymphoma.~   "
63946|NCT02729948|"~     This pilot clinical trial studies how well tethered capsule endoscope works in screening~     patients with Barrett esophagus (BE), a condition where the lining of the esophagus has~     changed or has been replaced with abnormal cells that may lead to cancer also called~     esophageal cancer. In an attempt to prevent the progression from BE to esophageal cancer,~     patients undergo a standard procedure called esophagogastroduodenoscopy (EGD) where patients~     are sedated and the doctor uses an endoscope to examine the tissue in the esophagus. Tethered~     capsule endoscope is a tiny capsule with a laser scan inside and a very thin cord attached to~     it. Patients swallow the capsule and the thin cord keeps the capsule in specific area in the~     esophagus. After pictures of the lining of esophagus are taken, the capsule is removed using~     the thin cord. Tethered capsule endoscope may be able to identify tissue changes in patients~     with BE without the need for sedation or anesthesia, thus eliminating the associated risks~     and costs associated with EGD.~   "
63947|NCT02729935|"~     Catheter-related bladder discomfort (CRBD) is defined as an urge to void or discomfort in the~     supra-pubic region; reported postoperatively in patients who have had urinary catheterization~     intra-operatively. In the present study, the investigators evaluated Parecoxib (P) for~     preventing CRBD in patients undergoing catheterization after transurethral resection of~     bladder tumor (TURBT).~   "
63968|NCT02729662|"~     Investigation of the therapeutic effects of tolvaptan in patients with autosomal dominant~     polycystic kidney disease This is a prospective 5-year study to compare the change in total~     kidney volume (TKV) before and after tolvaptan therapy, as the primary endpoint, in patients~     with ADPKD. Study results will be summarized, analyzed, and compiled into a research paper at~     3 years (data cut-off, March 31, 2018) and at 5 years (data cut-off, March 31, 2020).~   "
63948|NCT02729922|"~     CardioMEMS is an implantable wireless hemodynamic monitoring system which can transmit the~     pulmonary artery pressure. This device is FDA approved to be used as a diagnostic tool to~     help management of selected heart failure patients. Heart failure patients with NYHA class~     III heart failure, irrespective of the left ventricular ejection fraction, and a previous~     hospital admission for heart failure in the past 12 months, without stage IV or V chronic~     kidney disease are candidates to receive a CardioMEMS device. Our goal is to create a~     registry of all patients that receive a CardioMEMS device and monitor outcomes, primarily~     heart failure hospitalizations, heart failure related quality of life and re-admissions.~   "
63949|NCT02729909|"~     The purpose of this study is to evaluate the efficacy and safety of oral administration of 24~     ug of lubiprostone twice daily (BID) for 4 weeks in participants with chronic idiopathic~     constipation (CIC) compared with placebo.~   "
63950|NCT02729896|"~     This study will evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of~     obinutuzumab + Atezo + Pola in participants with relapsed or refractory FL and rituximab +~     Atezo + Pola in participants with relapsed or refractory DLBCL. The study will include an~     initial dose-escalation phase designed to determine the recommended Phase 2 dose (RP2D) for~     Pola in this treatment combination, followed by an expansion phase in which Pola will be~     given at the RP2D. All participants will receive induction treatment with obinutuzumab +~     Atezo + Pola for 6 cycles. FL participants achieving a complete response (CR), partial~     response (PR), or stable disease (SD) at the end of induction (EOI) will receive maintenance~     treatment with obinutuzumab + Atezo and DLBCL participants achieving a CR or PR at EOI will~     be eligible to receive consolidation treatment with rituximab + Atezo.~   "
63951|NCT02729883|"~     This pilot clinical trial studies Take the Fight in supporting and empowering patients with~     cancer through their treatment process. Patients with cancer are faced with many obstacles~     created by the current state of the healthcare system. The purpose of Take the Fight is to~     train college students, also called patients' navigators or strategists, to assist and~     support patients to navigate into the healthcare system and receive the care they need. The~     strategists are matched with patients and attend/coordinate most patients' medical~     appointments. The strategists also advance communications between the patient and the medical~     staff to facilitate both the exchange of medical information as well as increase the~     patient's compliance with treatment. Take the Fight may improve the health and quality of~     life outcomes of cancer patients during critical treatment periods by increasing treatment~     compliance, eliminating barriers to better care, and increasing clinical trial participation.~   "
63952|NCT02729870|"~     Fasting ketoacidosis adds morbidity to children affected by gastrointestinal infections. The~     investigators investigate oral glucose gel for its effectiveness in rapidly reducing~     ketoacidosis and for improvements in oral hydration therapy success.~   "
63953|NCT02729857|"~     The aim of the study is to understand more about how different fatty acids modulate~     postprandial lipid metabolism and inflammatory response.~   "
63954|NCT02729844|"~     NeoLifeS is a cohort follow up study that prospectively collects data of regular care of~     children born preterm in the University Medical Center Groningen (UMCG) and aims to improve~     the quality of care for these children.~      NeoLifeS-Heart is a sub-study that focuses on the problem that a high proportion of preterm~     infants develop cardiovascular disorders. Related to the immaturity of their lungs, preterm~     infants are at risk to develop the condition Bronchopulmonary dysplasia (BPD). Also, the~     vasculature of the lungs is often not fully developed, making them more vulnerable for the~     development of Pulmonary Hypertension (PH), a high blood pressure in the lungs. 15-20% of the~     infants with extremely low birth weight are believed to develop PH, this proportion has been~     suggested to raise to 50% in infants with severe BPD. The presence of PH significantly~     worsens the prognosis and survival of these children.~      The condition PH is insufficiently characterized. Knowledge of incidence, prevalence, risk~     factors for the development of PH and survival, will be the first step in improving detection~     strategies, possible treatment options and thereby prognosis and survival of these children.~      Objective: To determine the incidence and prevalence of PH in preterm infants. In addition we~     aim to identify risk factors for the development of PH and determine the survival and~     prognosis of these preterm infants.~      Study design: A prospective cohort study. Study population: All preterm infants, admitted at~     the neonatology UMCG, born <30 weeks and/or birth weight < 1000 gram, who participate in~     NeoLifeS Primary parameters: The occurrence of PH (Incidence and Prevalence).~      Secondary parameters:~        -  Maternal and neonatal patient characteristics that are potential risk factors for the~          development of PH,~        -  Morbidity-score (quality of life and hospital admissions) and mortality.~   "
63955|NCT02729831|"~     This study is a 2X2 factorial randomized trial that will the examine the comparative~     effectiveness of two patient decision aids for hip and knee osteoarthritis as well as the~     impact of a surgeon-focused intervention.~   "
63956|NCT02729818|"~     Microperimetry is a relatively new and extremely sensitive method of assessing visual~     function. It projects light stimuli onto a defined area of the retina to map retinal~     perceptual thresholds. Participants look at a focal point and press a button to indicate when~     they have seen a light stimulus. The stimuli vary in intensity to find the participant's~     visual sensitivity.~      Microperimetry is carried out in low light conditions. Before testing, participants must~     adapt to the low light conditions in a process called 'dark adaptation.' Currently there is~     no consensus on the optimal time needed for dark adaptation. Investigators know that visual~     sensitivity differs in differing light conditions. Failing to sufficiently dark-adapt may~     therefore adversely affect test results.~      The aim of this study is to establish the optimal length of dark adaptation for~     microperimetry performance in healthy volunteers. On day 1, participants will undergo~     training field tests to reduce a learning effect affecting the results. Tests will then be~     performed following 5 mins adaptation, 10 mins adaptation and 30mins adaptation, On day 2,~     participants will perform testing following no adaptation time, 15 mins adaptation, and 20~     mins adaptation. Statistics will be used to determine the effect of adaptation time on~     average threshold measures.~   "
63969|NCT02729649|"~     ArmAssist is low cost simply robotic devise for arm training and assessment. It is suitable~     for extended home rehabilitation and prolonged hospital rehabilitation without therapist~     supervision. The device contains several games which are structured as exercise for disabled~     patients. The primary aim of this study is to correlate efficacy of the arm training with~     ArmAssist robot system to conventional care modified by duration and structure of exercise.~     The secondary aim of this study is to measure the correlation between standard clinical~     assessment scales and ArmAssist-based assessment metrics.~   "
64089|NCT02728089|"~     This is a Phase 3, multi-site, non-randomized, open-label study evaluating the safety and~     efficacy of MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) for the treatment of~     complicated urinary tract infection (cUTI) including pyelonephritis (uncomplicated or~     complicated pyelonephritis and complicated lower urinary tract infection) in Japanese~     participants. Efficacy will be primarily assessed by microbiological response defined as~     eradication of the baseline pathogen or pathogens.~   "
63957|NCT02729805|"~     Preventive analgesia is when an administered analgesic drug provides reduction in pain beyond~     its duration of action. This can be used to reduce acute postoperative pain and prevent~     occurrence of chronic post-surgical pain.~      According to the International Association for the Study of Pain (IASP), chronic pain can be~     defined as pain that persisted beyond the time of normal tissue healing (usually 3 months)~     and that was not related to other causes. Mastectomy is associated with a high incidence of~     chronic post-surgical pain. Breast cancer is the most common malignancy affecting females~     around the world. Many undergo mastectomy as part of curative treatment. However, a~     significant proportion of patients experience chronic post-surgical pain. This results in~     significant negative impact on physical, psychological and social wellbeing.~      Ketamine is an intravenous anaesthetic drug with analgesic effects. It can be used to treat~     both acute and chronic pain. A recent meta-analysis of different surgeries showed that~     patients receiving ketamine had a modest but statistically significant reduction in incidence~     of chronic post-surgical pain. In a small sample single dose pilot study, patients given low~     dose intravenous ketamine intraoperatively had a statistically non-significant reduction in~     incidence of pain around the surgical scar at three months after radical mastectomy.~     Randomized control trials with larger sample sizes are needed to determine the effectiveness~     and optimal dosing regime of ketamine for reduction of chronic post-mastectomy pain. It is~     therefore hypothesized that intravenous ketamine given intraoperatively will reduce the~     incidence and severity of chronic pain after modified radical mastectomy. A double blind~     randomized controlled trial comparing placebo group with two different doses of ketamine is~     proposed.~      The mechanism of action of ketamine in reducing pain is complex and multiple. How ketamine~     can prevent and reduce chronic pain is unknown. Ketamine has been shown to reduce immediate~     gene expression at site of mechanical injury. Transient Receptor Potential Vanilloid 1~     (TRPV1) and Transient Receptor Ankyrin 1 (TRPA1) are receptors shown to mediate acute and~     chronic pain. Ketamine, shown to affect gene expression, may alter the expression of TRPV1~     and TRPA1 via epigenetic mechanisms.~   "
63958|NCT02729792|"~     Repetitive transcranial magnetic stimulation (rTMS) is an emerging treatment for medically~     refractory major depressive disorder (MDD). rTMS involves direct stimulation of cortical~     neurons using externally applied, powerful, focused magnetic field pulses. Dozens of studies~     and several meta-analyses over the last 15 years have shown that rTMS of the dorsolateral~     prefrontal cortex (DLPFC) produces statistically significant improvements in MDD, even when~     medications have failed. However, other possible targets may also yield improvement in~     symptoms.~      In an attempt to enhance the therapeutic efficacy of current interventions for TRD, attention~     has turned to identifying domain-specific biomarkers in hopes of ultimately individualizing~     and predicting treatment response. Unfortunately, the precise nature of this relationship is~     less than clear, as reflected by the fact that even now there are no established biomarkers~     that are used routinely in clinical practice to aid in diagnosis. This study also seeks to~     examine a comprehensive suite of biomarker measurements (MRI, neurophysiology, and~     genomics/proteomics) before and after rTMS treatment.~   "
63959|NCT02729779|"~     Chronic low back pain is potentially disabling for the elderly, and physical exercises are~     considered the best treatment for this problem. The Pilates method has been proven effective~     in the improvement of pain and function in patients with low back pain. However, the evidence~     about the effectiveness of Pilates method in the treatment of elderly patients with low back~     pain is scarce. Thus, the aim of this study is to investigate the effectiveness of the~     Pilates method compared to aerobic exercise in elderly with chronic non-specific low back~     pain. This randomized controlled trial with two arms and blinded assessor will include 74~     patients aged between 65 and 85 years, of both sexes, complaining of chronic non-specific low~     back pain persisting for more than three months and pain intensity greater than 3 points in~     the Pain Numerical Rating Scale. The elderly will be randomized into two groups: Pilates~     Group (n = 37) with exercises based on Pilates method; and Aerobic Group (n = 37) with~     aerobic exercises, stretching and relaxation. Both groups will hold treatment twice a week~     with duration of 60 minutes for eight weeks. The primary outcomes will be: pain intensity and~     general disability assessed eight weeks after randomization. Secondary outcomes will be: pain~     intensity and general disability evaluated six months after randomization; global impression~     of improvement, specific disability and dynamic balance, muscle strength of the gluteus~     maximus, gluteus medius and lateral hip rotators and pressure pain threshold evaluated eight~     weeks and six months after randomization. We expect that the results of this study contribute~     to the clinical decision-making with respect to pain reduction and, consequently, improving~     balance and functionality of elderly with chronic low back pain.~   "
63960|NCT02729766|"~     Empagliflozin (Jardiance)® is a sodium glucose co-transporter 2 (SGLT2)-Inhibitor, which is a~     new treatment option developed for patients with diabetes mellitus type 2. The SGLT2 is~     expressed in the proximal tubule and reabsorbs approximately 90 percent of the filtered~     glucose. The inhibition of SGLT2 results in renal excretion of glucose with subsequent~     osmotic diuresis. This mechanism could result in a therapeutic effect in patients with~     hypotonic hyponatremia as in the syndrome of inappropriate antidiuretic hormone (ADH)~     secretion (SIAD). Because patients with SIAD usually have several comorbidities and different~     medications, studies investigating the physiological effects are difficult to interpret.~     Therefore a model to study the possible physiological effect of SGLT2-inhibitors in hypotonic~     hyponatremia as in SIAD is needed.~      The aim of this study is to evaluate whether empagliflozin (Jardiance)® has an effect on~     serum sodium levels of healthy volunteers with induced hypotonic hyponatremia.~   "
63961|NCT02729753|"~     This study will evaluate the CryoBalloon™ Full Ablation System for the ablation of human~     esophageal epithelium in patients scheduled to undergo esophagectomy for reasons unrelated to~     the objective of the study~   "
63962|NCT02729740|"~     The primary objective of this study is to gather post market data on the Penumbra SMART Coil™~     System in the treatment of intracranial aneurysms and other malformations.~   "
63963|NCT02729727|"~     To evaluate the safety and treatment effect of the CryoBalloon™ Full Ablation System for the~     ablation of human esophageal epithelium in patients scheduled to undergo esophagectomy~   "
63964|NCT02729714|"~     The purpose of this study is to see if the study drug, suvorexant, is safe and effective in~     treating symptoms of insomnia in people with Parkinson's Disease. It is anticipated that a~     total of 20 subjects, 30 to 80 years of age, with Parkinson's Disease and symptoms of~     insomnia will participate in the study at this site~   "
63965|NCT02729701|"~     The purpose of this study is to learn whether daily use of Duavee® is accepted and tolerated~     by peri- and post-menopausal women at moderate risk for development of breast cancer.~   "
63966|NCT02729688|"~     Objective of this study are to compare the interface pressure by applying ordinary elastic~     bandage (OEB) and CPG-EB. In addition, investigators compared the percentage of patients who~     could apply the optimal pressure with OEB and CPG-EB.~   "
64013|NCT02729077|"~     This study investigates the incidence of postoperative respiratory complications (PRCs)~     including: oxygen desaturation events, tracheal re-intubations within 48 hours of surgery,~     and failure to wean from ventilator within 48 hours of surgery - in patients with and without~     risk factors for OSA undergoing elective, non-cardiac surgery (NCS).~   "
63970|NCT02729636|"~     Functional electrical stimulation (FES) is multi-pad system that allows fast optimization of~     stimulation patterns for achieving strong dorsiflexion/plantar flexion and automatic~     real-time control of ankle joint during FES assisted walking. The main aim of the present~     study is to compare the effects of functional electrical stimulation gait training after~     stroke and overground conventional physical therapy. With the assumption that the advanced~     method of functional electrical stimulation will improve gait parameters and functionality in~     patients with foot drop before and after FES treatment the objectives of this study are to~     examine the effects of functional electrical stimulation using FES:a method on indicators of~     walk and function in patients with foot drop before and after FES treatment.~   "
63971|NCT02729623|"~     Growing evidence supports the use of inhaled cannabis for neuropathic pain; the lack of~     standard inhaled dosing holds a major obstacle in cannabis becoming a pharmacological~     treatment for neuropathic pain. The objective of this study is to explore the~     pharmacokinetics, safety, tolerability, and ease of use of a portable metered-dose inhaler,~     (i.e. CannaHALER) for cannabis in a cohort of 12 healthy volunteers. In a single escalating~     dose methodology, open-label study, patients will inhale a single 10 ± 0.1 mg / 15 ± 0.1 mg /~     20 ± 0.1 mg / 25 ± 0.1 mg dose of cannabis using the Kite Systems cannaHALER cannabis Inhaler~     device. Blood samples will be taken at baseline and up to 30 minutes. Adverse events will be~     monitored following the inhalation.~   "
63972|NCT02729610|"~     To investigate if bronchial blocker is more suitable for one-lung ventilation during~     thoracoscope assisted mitral valve replacement surgery with Cardiopulmonary Bypass than the~     double-lumen endobronchial tube.~   "
63973|NCT02729597|"~     The natural history of brain affection in myotonic dystrophy types 1 and 2 is still unknown.~     The investigators designed a 5-year longitudinal neuropsychological and neuroimaging~     follow-up study to address this issue. Myotonic dystrophy type 1, myotonic dystrophy type 2~     patients, and healthy controls were enrolled. All participants undergo clinical-neurological~     examinations, neuropsychological analyses according to a 13-item neuropsychological test~     battery, and 3T-brain MRI including voxel-based morphometry and diffusion tensor imaging at~     baseline and at follow-up using identical examination protocols.~   "
63974|NCT02729584|"~     The study aims at evaluating in normal weight and obese subjects those factors such as taste~     sensitivity and circulating endocannabinoids in influencing dietary choice and thereby lipid~     and energy metabolism in order to design personalized nutritional strategies.~   "
63975|NCT02729571|"~     Randomized, controlled, double blind clinical trial in 2 stages (adult stage, infant stage).~     The first stage includes 18 HIV uninfected, QFT negative, BCG vaccinated, adult participants,~     randomized 1:1 to receive BCG Vaccine SSI or MTBVAC at equivalent dose (5x10E05 CFU/0.1mL)~     (n=9 in each group). Upon favourable safety review by the DSMB for all 18 adults up to day 28~     after study vaccination, the second stage will commence in thirty-six (36) HIV unexposed, BCG~     naïve, newborn infants, randomized 1:3 to receive BCG Vaccine SSI or MTBVAC at one of three~     different dose levels ( (n=9 in each group).~   "
63976|NCT02729558|"~     Objective: To improve local control following complete resection of a single brain metastasis~     using fractionated local stereotactic radiotherapy, whilst maintaining neurological~     functioning, neurocognition and quality of life.~      Study design: Multicenter randomized phase III, with at least three high-volume Dutch centers~     participating in the trial. Stratification on primary tumor type and age.~      Study population: Patients undergoing complete resection of a single brain metastasis,~     confirmed by an early (i.e. within 72 hours) postoperative contrast-enhanced MR scan.~      Study intervention: Patients will be randomized between observation alone (standard arm) and~     local stereotactic radiotherapy in three fractions of 8 Gy to the surgical cavity (study~     arm).~      Main study parameters: Primary objective: local control rate at 6 months. Secondary~     objectives: local control rate at 12 months, neurological functioning, freedom from clinical~     neurological progression, performance status, quality of life, toxicity, steroid use,~     neurocognition and overall survival.~   "
63977|NCT02729545|"~     This study evaluates the efficacy and safety in improving ovarian function of polycystic~     ovarian syndrome in adults. Half of patients will receive Dong's extra-point acupuncture~     therapy, while the other half will receive Diane-35 as the control group.~   "
63978|NCT02729532|"~     A parallel-group prospective cohort study among adult persons living with HIV/AIDS to study~     the effect of a new TB diagnostic test, Xpert MTB/RIF on: 1) TB case detection; 2) time to TB~     diagnosis and TB treatment; 3) presumptive TB patient drop-out from the TB diagnostic~     cascade before starting TB treatment; and 4) loss to follow-up after initiation of TB~     treatment.~   "
63979|NCT02729519|"~     Balloon predilatation of the aortic valve has been regarded as an essential step during the~     transcatheter aortic valve implantation (TAVI) procedure. However, recent evidence suggested~     that aortic valvuloplasty may be harmful and that high success rate may be obtained without~     prior dilatation of the valve. We hypothesize that TAVI performed without predilatation and~     using new generation balloon expandable prothesis is associated with a better net clinical~     benefit in comparison with procedure performed with pre dilatation.~   "
63980|NCT02729506|"~     Hepatocellular Carcinoma (HCC) is a primary liver cancer. It is the 6th most common~     malignancy and the 3rd killers of all tumors worldwide with an incidence of 626,000 new~     patients a year. The intermediate stage of HCC is controlled by radiological interventions~     such as Transarterial Chemoembolization (TACE) or Radioembolization. Although 90Y~     radioembolization is increasingly being used in clinical practice, there is no high quality~     clinical evidence to justify this. To date, no prospective studies have been performed~     comparing both treatment modalities (TACE vs 90Y) in a randomized setting. This randomized~     controlled trial is designed to prospectively compare TACE and 90Y for treatment of patients~     with unresectable (BCLC intermediate stage) HCC. This will be done by recruiting 75 patients~     in each arm from. Investigators will compare between the two groups the time to progression~     (TTP) as the primary outcome and also examine time to local progression (TLP) as well as~     other factors like overall survival, response to therapy, toxicities and adverse events,~     quality of life and treatment-related costs.~   "
64134|NCT02727504|"~     Investigators sought to demonstrate that the increase in the stroke volume during a~     dobutamine stress echocardiography might impact the prognosis of a patient addressed for a~     low flow low gradient suspected severe aortic valve stenosis.~   "
63981|NCT02729493|"~     This single-arm,multicenter Phase 2 trial will treat the patients who have relapsed or~     refractory liver cancer with an infusion of the patient's own T cells that have been~     genetically modified to express a chimeric antigen receptor(CAR)that will bind to tumour~     cells that express the EPCAM protein on the cell surface.The study will determine if these~     modified T cells help the body's immune system eliminate tumour cells.The trial will also~     study the safety of treatment with CAR-T,how long CAR-T cells stay in the patient's body and~     the impact of this treatment on survival.~   "
63982|NCT02729480|"~     The purpose of this study is to assess the effectiveness of craniofacial nerve stimulation~     for the treatment of neuropathic pain.~   "
63983|NCT02729467|"~     The purpose of this study is to assess the effects of itraconazole, a strong cytochrome P~     (CYP)3A4 and p-glycoprotein (PgP) inhibitor, and rifampicin, a CYP3A4, uridine~     5'-diphospho-glucuronosyltransferase (UGT), and PgP inducer, and an inhibitor of organic~     anion-transporting polypeptide (OATP), on the single-dose pharmacokinetics (PK) of~     JNJ-53718678 in healthy adult participants.~   "
63984|NCT02729454|"~     Introduction Although drug therapy is the mainstay of treatment for Parkinson's disease, the~     therapy also has its importance by means of exercises which maintains the muscular activity~     and preserve mobility. One of the techniques that has been used for physical therapy is the~     mental practice of the mental simulation of movement, aiming at learning or improvement of~     motor skills through the cortex areas of activation responsible for the movement of~     preparation before it is executed. In patients with Parkinson's disease motor anticipation~     this system is compromised, culminating in the march changes and increased risk of falls.~     Objective: To evaluate the effects of mental practice on physical therapy on the march and~     the risk of falls in people with Parkinson's disease. Method: The study is defined as a~     randomized clinical trial with systematic recruitment. Recruitment will be conducted at the~     Clinic of Neurology, Hospital das clinics Federal University of Pernambuco (Pro-Parkinson~     Project: Neurology) and the intervention will be held at the same hospital physiotherapy~     clinic. Both the control group and the trial will be subjected to 15 therapy sessions twice a~     week, lasting 40 minutes for physical therapy and 15 for mental practice.~   "
63985|NCT02729441|"~     The investigators conducted a single center study controlled study involving 20 patients with~     Type 2 Diabetes and hypertension who were randomly assigned to receive ramipril 10mg or~     perindopril 8mg. The primary endpoint was difference in urine albumin-creatinine ratio at~     night time and during the day. Secondary endpoint was measurement of blood pressure.~   "
63986|NCT02729428|"~     The overall goal of observational study is to examine the age-related and habitual exercise~     training status-related differences in structural and functional changes in the human brain,~     detected by magnetic resonance (MR) imaging.~   "
63987|NCT02729415|"~     Androgenetic alopecia (AGA) is the most common form of hair loss and affects 50% and 23% of~     Caucasian men and women, respectively, over the age of 50. The percentage of men and women~     affected over the age of 70 increases to 80% and 60% of Caucasian men and women,~     respectively. Although alopecia is considered a minor dermatologic condition, it is seen as a~     serious condition with major life consequences by those with alopecia and has been associated~     with increased incidence of myocardial infarction, hypertension and hypercholesterolaemia.~     Androgenetic alopecia is associated with feelings of anxiety, depression and various~     personality disorders among men and women due to physical appearance. Depression, anxiety,~     aggressiveness, impaired quality of life and social inadequacy have been documented. The~     presence of alopecia in women is particularly stressful.~      ADSCs (Adipose Derived Stromal Cells), also called Stromal Vascular Fraction (SVF) cells,~     include regenerative cell populations derived from adipose tissue and thus are potentially~     important to multiple disease processes and therapeutic applications for the repair and~     regeneration of acute and chronically damaged tissues. It has been postulated that SVF cells~     may promote hair regeneration by increasing the hair-inducing ability of dermal papillae (DP)~     cells.~      The general objective of this study is to conduct a safety and feasibility study of a single~     injection of autologous adipose-derived SVF cells for the treatment of alopecia.~   "
63988|NCT02729402|"~     The subjects will be age 65 years and older, with no upper limit of age range with hearing~     loss that are candidates for standard-of-care cochlear implant.~      Cognitive tests will be administered preoperative, and postoperative at 6 and 12 month~     intervals.~   "
63989|NCT02729389|"~     The purpose of this research study is to investigate how social standing in a game of~     Monopoly may influence behavior.~   "
63990|NCT02729376|"~     This is an open label, single dose, 1 period study of [14C] galeterone.~   "
63991|NCT02729363|"~     Our goal is to improve the self-management of pain and stress in adult outpatients with~     sickle cell disease (SCD) by determining the feasibility of a self-managed guided relaxation~     (GR) stress reduction intervention using a tablet-based mobile device. Currently, opioid~     analgesics are primarily used to treat SCD pain while self-managed behavioral modalities such~     as GR, are rarely used. Little is known about the effects or mechanisms of GR on pain and~     stress, in adults with SCD. Emerging evidence from the hypothalamic pituitary adrenal (HPA)~     axis theory offer insights for understanding the mechanisms. Adding GR as a supplement to~     analgesic therapies will address the paucity of self-management strategies for controlling~     pain in SCD. GR is a simple and cost-effective non-drug intervention that could reduce pain~     and stress in outpatients with SCD. GR is an intervention where outpatients with SCD are~     directed to listen to and view audio-visual recordings while they visualize themselves being~     immersed in that scene.~   "
64014|NCT02729064|"~     Intranasal insulin is reported to improves memory performance in patients suffering from~     cognitive impairment. The investigators have previously shown that intraoperative insulin~     administration preserves both short and long-term memory function after cardiac surgery.~     Applying intranasal insulin bypasses blood-brain barrier and cause elevation of insulin~     concentrations in the cerebrospinal fluid without major effects on peripheral insulin level.~     Patients undergoing major surgery are exposed to carbohydrate and insulin metabolism~     alteration. The goal of the study is to study the effect of intranasal insulin on blood~     glucose, plasma and cerebrospinal insulin concentration in patients undergoing cardiac~     surgery or endovascular thoracic aneurysm repair.~   "
67471|NCT02683798|"~     A study to determine the effectiveness of two weight loss maintenance interventions in~     Counterweight Plus, a structured weight management programme.~   "
63992|NCT02729350|"~     The goal of this research study is to improve the self-management of pain, stress, and~     cognitive/affective symptoms that may result in adult inpatients with sickle cell disease~     (SCD) by determining the feasibility of a self-management guided relaxation (GR) stress~     reduction intervention using a tablet-based mobile device. Currently, opioid analgesics are~     primarily used to treat SCD pain while self-managed behavioral modalities such as GR, are~     rarely used, particularly, in inpatient settings. Little is known about the effects or~     mechanisms of GR on pain, stress, and cognitive/affective symptoms in adults with SCD~     hospitalized with pain. Emerging evidence from the hypothalamic pituitary adrenal (HPA) axis~     theory offer insights for understanding the mechanisms. Adding GR as a supplement to~     analgesic therapies will address the dearth of self-management strategies for controlling~     pain in SCD. GR is a simple and cost-effective non-drug intervention that could reduce pain~     and stress in inpatients with SCD. GR is an intervention where inpatients with SCD are~     directed to listen to and view audio-visual recordings while they visualize themselves being~     immersed in that scenario.~   "
63993|NCT02729337|"~     The investigators propose to develop a comprehensive, text messaging-based HIV prevention~     program for Ugandan adolescents 18-22 years of age.~   "
63994|NCT02729324|"~     Radiation therapy remains the principal treatment for nasopharyngeal carcinoma (NPC).~     Although intensity modulated radiation therapy (IMRT) has been widely used in China nowadays,~     radiation dermatitis is still common. It has an impact on pain and quality of life, and if~     severe, may lead to interruption of the radiation schedule for the patient. Trolamine~     (Biafine; Genmedix Ltd, France) is commonly prescribed at the beginning of radiotherapy for~     preventing acute radiation-induced skin toxicity in China. However, as long as grade ≥2~     radiation dermatitis is developed, trolamine is not allowed to use any more. Medical~     Radiation Protectants (FORRAD®) is a new kind of topical agents for prevention and treatment~     of radiation dermatitis. It could be used during the course of radiotherapy, even when grade~     ≥2 dermatitis is developed. This randomized phase II study is aimed to assess the~     effectiveness and safety of Medical Radiation Protectants (FORRAD®) for the prevention and~     treatment of acute radiation-induced dermatitis of grade 3 or higher during IMRT for patients~     with NPC, compared with trolamine.~   "
63995|NCT02729311|"~     Preventing Loss of Independence through Exercise (PLIÉ) is a unique, multimodal movement~     program for people with dementia (affected individuals) that is taught by trained instructors~     and combines physical, mental and social activities. The Paired PLIÉ Program is an adapted~     version designed for pairs of affected individuals and care partners. The goal of this study~     is to perform a randomized, controlled trial (RCT) with a delayed start design to examine the~     effects of the Paired PLIÉ Program on function and quality of life in affected individuals~     and care partners.~   "
63996|NCT02729298|"~     TP-0903 is a novel oral inhibitor that targets AXL kinase and reverses the mesenchymal~     phenotype associated with advanced cancers. Preclinical studies have shown promising~     antitumor activity of TP-0903 as a single agent against a variety of tumor types in both in~     vitro and in vivo studies.~      This first-in-human Phase 1a study is conducted to identify the maximum tolerated dose (MTD)~     of TP-0903 administered orally to patients with advanced solid tumors and to identify the~     safety profile and Recommended Phase 2 Dose (RP2D) of TP-0903. Once the MTD has been~     established, additional patients with specific tumor types (advanced solid tumors that have~     progressed despite immunotherapy*, EGFR+ Non Small Cell Lung Cancer [NSCLC] and have~     progressed on ≤2 lines of oral TKIs*, BRAF-, KRAS-, or NRAS-mutated Colorectal Carcinoma~     [CRC] for whom there is no standard therapy remaining, persistent/recurrent Ovarian Cancer~     who would be platinum refractory/ resistant and have had any number of lines of prior~     therapy, and BRAF-mutated Melanoma that has not responded to immunotherapy or a combination~     BRAF/MEK inhibitor) will be enrolled at the MTD in the Phase 1b study. Data collected from~     patients enrolled in each of these additional cohorts will be used for to confirm safety,~     explore potential biomarkers, and evaluate potential signals of activity when TP-0903 is~     administered to specific groups of heavily pretreated patients or given in combination with~     immunotherapy or a tyrosine kinase inhibitor (TKI).~      *Patients with immunotherapy-resistant tumors or EGFR+ NSCLC who are enrolled in these~     expansion cohorts will continue treatment with their previous immunotherapy or TKI regimens,~     respectively, and add TP-0903. The rationale is based on preclinical data that has shown that~     the combination is superior in patients who have progressed on prior immunotherapy or a TKI.~      The study will investigate the safety, pharmacokinetics, pharmacodynamics, and preliminary~     anti-tumor activity profiles.~   "
63997|NCT02729285|"~     The scleral buckle surgery is an effective way in treating retinal detachment (RD) patients.~     Retrobulbar block has been proved effective in scleral buckle surgery. Though retrobulbar~     anesthesia saves operative time and money compared to general analgesia, the intraoperative~     pain is frequent and a proportion of postoperative pain is often ignored. Ketorolac has been~     demonstrated to be a preemptive analgesia in other diseases such as adenotonsillectomy,~     posterior lumbar spinal fusion, laser-assisted subepithelial keratectomy (LASEK), and so~     forth. The aim of the investigators study is to determine the safety and preemptive analgesic~     effect of ketorolac in the perioperative pain control of patients undergoing RD surgery under~     retrobulbar anesthesia.~   "
63998|NCT02729272|"~     The aim of this randomized trial was to compare the degree of surgical smoke obstructing~     vision and thermal damage caused by two different ESDs (ultrasonic versus monopolar ESD) in~     colpotomy during total laparoscopic hysterectomy.~   "
63999|NCT02729259|"~     This study is designed to find additional methods to reduce pain during wound care. In this~     study the investigators use virtual reality (a form of distraction) in addition to pain~     medication during a burn wound care.~   "
64000|NCT02729246|"~     The main purpose of this project is to further explore the metabolic effects and the~     mechanisms underlying the improvement in glucose homeostasis following bariatric surgery. The~     project will involve both prevention and treatment of Type 2 Diabetes (T2D), and both~     pre-diabetic as well as diabetic subjects with obesity will be included. This part of the~     project focuses on patients with manifest T2D and they will be assigned to surgical and~     non-surgical intervention, respectively, in a strictly controlled and randomized manner.~   "
64028|NCT02728882|"~     This single-arm, multicenter Phase 2 study will treat the patients who have Recurrent or~     refractory diffuse large B cell lymphoma with an infusion of the patient's own T cells that~     have been genetically modified to express a chimeric antigen receptor (CAR) that will bind to~     tumour cells that express the EPCAM protein on the cell surface.The study will determine if~     these modified T cells help the body's immune system eliminate tumour cells.The trial will~     also study the safety of treatment with CAR-T,how long CAR-T cells stay in the patient's body~     and the impact of this treatment on survival.~   "
64557|NCT02721979|"~     This phase II trial studies how well apalutamide works in treating patients with prostate~     cancer who are in active surveillance. Testosterone can cause the growth of prostate cancer~     cells. Hormone therapy using androgen receptor antagonist apalutamide may fight prostate~     cancer by blocking the use of testosterone by the tumor cells.~   "
64001|NCT02729233|"~     Ulcerative colitis (UC) is a chronic relapsing inflammatory bowel disease (IBD). UC is an~     ongoing disease of the colon or large intestine. Studies have shown that leakiness of the gut~     plays a major role in the development of UC. Leakiness of the gut is a condition that is a~     result of damage to the intestinal lining, making it less able to protect its internal~     environment as well as to filter needed nutrients and other substances. Some bacteria,~     toxins, and waste not normally absorbed may get into the blood stream.~      Golimumab is an FDA approved medication used for the treatment of moderate to severe~     ulcerative colitis. The investigators have evidence to suggest that measuring the leakiness~     of the gut using a tool called a confocal laser endomicroscope may be able to predict how~     well a patient's body will respond to treatment of UC with golimumab. Confocal laser~     endomicroscopy (CLE) is an FDA approved technique that can look at the cells of a patient's~     gut during colonoscopy to assess the leakiness of gut.~      The objective of this study is to determine how the leakiness of the gut in patients with UC~     can predict response to golimumab therapy.~   "
64002|NCT02729220|"~     The purpose of this study is to find out if subjects with chronic obstructive pulmonary~     disease have signs of accelerated ageing in their airways.~   "
64003|NCT02729207|"~     The safety and the efficacy of the Esflurbiprofen Hydrogel Patch will be assessed in~     comparing with placebo in the treatment of acute pain due to ankle sprain~   "
64004|NCT02729194|"~     Pazopanib is an orally administered multi-kinase inhibitor targeting VEGFR (vascular~     endothelial growth factor receptor), PDGFR (platelet derived growth factor) and c-kit, which~     are critical to growth and proliferation of neoplastic cells. Pazopanib has been FDA approved~     for advanced renal cell carcinoma (RCC) with a clear cell component. Conventional Pazopanib~     dosing WITHOUT FOOD is with an initial dose of 800 mg by mouth daily. Investigators~     hypothesize that administration of pazopanib with low fat meal would be safe and feasible~     with secondary implications of higher pazopanib levels; potentially translating into greater~     anti-tumor efficacy in advanced renal cell cancer, with significant cost savings. In the~     proposed pilot study, investigators seek to test the feasibility and practicality of this~     approach and gather preliminary data on adverse effects and the safety profile. Investigators~     hope to ameliorate any potential for greater toxicities with a dynamic dosing design that~     incorporates adverse events from each cycle into dosing for the next cycle and a structured~     symptom specific plan.~   "
64005|NCT02729181|"~     The investigators hypothesize that treatment with non-invasive spinal decompression reduces~     discogenic low back pain (LBP), decreases visual analog pain scale scores, increases~     activities of daily living and decreases medication use.~   "
64006|NCT02729168|"~     An open label, non-comparative bridging study to evaluate the safety of Rabies vaccine~     INDIRAB® in Healthy Vietnamese volunteer aged from 5 years old.~   "
64007|NCT02729155|"~     This trial is a 2 x 2 factorial design, double-blinded, randomized controlled trial to~     evaluate efficacy and safety of remote ischemic preconditioning and postconditioning for~     prevention of contrast-induced acute kidney injury in patient undergoing coronary angiography~     and angioplasty~   "
64008|NCT02729142|"~     The optimal management of calcium and phosphate metabolism regulation in chronic kidney~     disease (CKD) is important in preventing fracture risk and vascular calcification and thus~     morbidity and mortality, global and vascular.~      Kidney transplant in a CKD context, usually with a pre-existing underlying renal~     osteodystrophy, malnutrition, chronic inflammation, hypogonadism and immunosuppression~     protocols still often made up of high-dose corticosteroid therapy, are all theoretical~     factors of post-transplantation bone disease. For other solid organ transplants, even though~     there is generally no underlying renal osteodystrophy before the transplant, the proportion~     of osteoporotic patients at the time of transplant is substantial. The bone risk in the~     immediate post-transplant period is notable.~      Patients' follow-up is based on biological, radiological and histological tools. Bone~     densitometry (DXA) is used to measure bone mass. However, recent international~     recommendations do not consider DXA as a valid tool to assess bone health in CKD patients.~     Moreover, it is less informative than peripheral quantitative tomography resolution~     (HR-pQCT). This latest technique, available in Lyon and Saint-Etienne, is more precise,~     allowing a three-dimensional study of the trabecular microarchitecture and compartmental~     volumetric bone density (total, cortical, trabecular), while similar to DXA in terms of~     radiation (less than 5 μSv). The prevention of cardiovascular risk factors is also part of~     the daily care of patients with a regular cardiac monitoring (heart ultrasound) and vascular~     (blood pressure, Doppler of the supra-aortic trunks).~      TRANSOS study aims to evaluate in a prospective cohort (longitudinal follow-up of 6 months),~     the bone status in patients receiving solid organ transplantation in the University Hospitals~     of Lyon and Saint-Etienne, using DXA and HR-pQCT (at baseline and month 6), in combination~     with classical biological and cardiovascular monitoring. Transplantation is an important~     activity in these two hospitals and this protocol provides the same bone follow-up for all~     solid organ transplants, with a reliable, efficient, non-invasive and low-dose radiation~     tool.~      The primary objective of TRANSOS study is to evaluate changes in tibial cortical density~     between the baseline and the 6th month post-transplant measured by HR-pQCT.~   "
64009|NCT02729129|"~     Air pollution exposure is a major environmental and public health concern. The findings from~     controlled exposure studies have given biological plausibility to the epidemiological~     associations, and have defined important pathways that may be amenable to intervention.~     Ultimately, there is a need to address how one may protect the public from these detrimental~     effects. Two studies have been performed assessing the cardiovascular effects of wearing a~     face mask in a highly polluted urban area in China in healthy volunteers and patients with~     coronary heart disease. These demonstrated lower blood pressure and increased heart rate~     variability when wearing a face mask as compared to not. The investigators aim to test if~     wearing a highly efficient face mask during exposure to dilute diesel exhaust abrogates the~     well-known adverse cardiovascular effects.~   "
64010|NCT02729116|"~     This study evaluates oral antimicrobial agents for the treatment of non-bacteremic acute~     urinary tract infection caused by Extended Spectrum Beta Lactamase producing Escherichia coli~     or Klebsiella pneumoniae in Post-kidney transplantation. Patients are treated with~     intravenous (IV) antibiotics follow by oral sitafloxacin or IV ertapenem.~   "
64011|NCT02729103|"~     This study will evaluate treatment patterns, mortality, healthcare resource utilization, and~     costs in patients with prostate cancer with bone metastases (primary objectives).~     Additionally, this study will evaluate opioid/analgesic use among lines of therapy in this~     patient population (secondary objective). The study is descriptive in nature and is meant to~     provide a greater understanding of the patterns of therapy observed in real-world clinical~     practice (in the absence of clear guideline recommendations with regards to treatment~     sequencing), to contribute to a greater understanding of the major cost drivers (thus~     better-informing payers), and to examine real-world mortality in such patients.~   "
64012|NCT02729090|"~     The Peripheral Arterial Disease prevalence is around 3-10 % of the world population. Exercise~     plays an important role in treating these patients.~   "
64015|NCT02729051|"~     This multicenter study will be conducted to compare the effect of FF/UMEC/VI with FF/VI plus~     UMEC on lung function after 24 weeks of treatment. This is a phase IIIB, 24-week, randomized,~     double-blind, parallel group multicenter study. This study will test the hypothesis that the~     difference in trough forced expiratory volume in one second (FEV1) between treatment groups~     is less than or equal to a pre-specified non-inferiority margin. Alternatively, this study~     will also test the hypothesis that the difference between treatment groups is greater than~     the margin. The triple therapy of FF/UMEC/VI in a single inhaler is being developed with the~     aim of providing a new treatment option for the management of advanced Global Initiative for~     Chronic Obstructive Lung Disease (GOLD) Group D COPD which will reduce the exacerbation~     frequency, allow for a reduced burden of polypharmacy, convenience, and improve lung~     function, health related quality of life (HRQoL) and symptom control over established~     dual/monotherapies. This study has a 2 week run in period where subjects will continue to~     have their existing COPD medications. At randomization, subjects will discontinue all~     existing COPD medications and will be assigned to treatment of FF/UMEC/VI, 100 microgram~     (mcg)/62.5 mcg/25 mcg and placebo or FF/VI, 100 mcg/25 mcg and UMEC, 62.5 mcg in a 1:1 ratio~     for 24 weeks. Subjects will have clinical visits at Pre-Screening (Visit 0), Screening (Visit~     1), Randomization (Week 0, Visit 2), Week 4 (Visit 3), Week 12 (Visit 4) and Week 24 (Visit~     5). A follow-up visit will be conducted at 1 week after the end of treatment period or after~     early withdrawal visit. Approximately, 1020 subjects will be enrolled in this study. There~     will be two pharmacokinetic (PK) groups (subset A and subset B). Approximately 120 subjects~     will be assigned to subset A and approximately 60 subjects will be assigned to subset B. The~     total duration of subject participation will be approximately 27 weeks, consisting of a~     2-week run-in period, 24-week treatment period and a 1-week follow-up period.~   "
64016|NCT02729038|"~     This study will be conducted to determine if altered renal function affects the plasma~     pharmacokinetics of gepotidacin, which will inform if dosing recommendations based upon renal~     impairment are required. The objective of this study is to compare the pharmacokinetics of~     gepotidacin administered as a 750 milligram (mg) intravenous (IV) dose in normal healthy~     subjects compared with subjects with mild, moderate, and severe renal impairment, and with~     subjects with end stage renal disease (ESRD). This is a Phase I, nonrandomized, open-label,~     parallel-group, multi-center, multi-part study. In Part 1, up to 16 subjects with normal~     renal function will be matched to approximately 8 subjects with moderate renal impairment,~     and approximately 8 subjects with severe renal impairment and/or subjects with ESRD not on~     hemodialysis for a total of approximately 32 subjects. In Part 2 (optional), approximately 4~     to 8 subjects with normal renal function (if enrolled), approximately 4 to 8 subjects with~     mild renal impairment, and approximately 4 to 8 subjects with ESRD on hemodialysis will be~     enrolled for a total of approximately 12 to 24 subjects. The duration from Screening to the~     Follow-up Visit will be approximately 44 days for Part 1 and approximately 50 days for Part~     2.~   "
64017|NCT02729025|"~     A study to assess the effects of proprotein convertase subtilisin/ kexin type 9 (PCSK9)~     inhibition on the arterial wall inflammation in patients with elevated lipoprotein(a).~   "
64018|NCT02729012|"~     The main objective of RinASol project is to assess in patients with seasonal Allergic~     Rhinitis the effect of hypertonic saline solution NACL 3%+NAHCO3 vs the effect of standard~     saline solution on nasal inflammation by means of nasal cytology.~      The secondary objective is the symptom score assessment by T5SS Questionnaire (Total Symptom~     Score 5)~   "
64019|NCT02728999|"~     Patient/Population: Women over the age of 18, who are not pregnant and are undergoing benign,~     robotic-assisted gynecologic procedures at Lutheran General Hospital.~      Intervention: Decreasing the angle of Trendelenburg for the procedure Control: Steep~     Trendelenburg, which is the usual standard of care, to the limit of the operative bed, which~     is 30 degrees.~      Outcome: Outcomes will include the mean angle of Trendelenburg in the experimental arm and~     the difference in Trendelenburg between the two arms. Additional outcomes included will be~     end tidal Carbon dioxide, peak airway pressure, mean arterial pressure, heart rate and~     arterial Carbon dioxide. Secondary outcomes will include operative time, blood loss and~     conversion to laparotomy.~   "
64020|NCT02728986|"~     The purpose of this study is to evaluate direct costs of Venous Leg Ulcers (VLU) management~     when two different compression systems are used.~   "
64021|NCT02728973|"~     Enhanced recovery after surgery (ERAS) was first proposed by Kehlet in Copenhagen Denmark,~     this is a new concept for the integration of the latest study of the surgical, anesthesia,~     and nursing. The purpose of optimization measures, reduce patient trauma stress, promote~     early rehabilitation of patients. The investigators plan to compare the feasibility, clinical~     effectiveness, and cost savings of an ERAS program with traditional treatment program at a~     major teaching hospital in China.The investigators will apply ERAS plan or traditional~     treatment regimens in the treatment of 100 cases of colorectal cancer patients, respectively.~     And data Compare the two programs about the incidence of postoperative complications,~     postoperative hospital stay, cost of hospitalization, and readmission rate will be collected.~   "
64022|NCT02728960|"~     The primary purpose of this study is to validate the High Definition Fiber Tracking~     (HDFT/HDFTAS) technology, so that faster, more reliable diagnosis can be implemented in~     Traumatic Brain Injury (TBI). This study will involve Traumatic Brain Injury Patients and~     normal controls, in addition to 30 pilot participants who will be undergoing MRI in order to~     develop a statistically sound range for the metrics derived from HDFT.~   "
64023|NCT02728947|"~     To study the profile of Neupro patch administrated at 2 mg, 4 mg, 6 mg and 8 mg/day weekly in~     patients with early-stage Parkinson's disease~   "
64024|NCT02728934|"~     The purpose of this study is to compare the proportion of patients with an infusion reaction~     in Rheumatoid arthritis (RA) patients treated with Golimumab Intravenous (IV) or Infliximab.~   "
64025|NCT02728921|"~     To study if plasma volume expansion is influenced by the rate at which a colloidal solution~     is administered in patients with a systemic inflammatory response induced by major abdominal~     surgery.~      Randomization will be performed postoperatively at the day of surgery with a 1:1 ratio with~     no stratification and the study drug will be given as a slow (3 hours) or rapid (30 minutes)~     intravenous infusion.~   "
64026|NCT02728908|"~     An open study evaluating the diagnostic accuracy of a microwave-based device to detect~     traumatic intracranial hemorrhage (TICH), by comparing measurements on trauma patients with~     confirmed vs excluded TICH~   "
64027|NCT02728895|"~     The purpose of this study is to assess the initial tolerability, safety and recommended phase~     2 dose of vedolizumab intravenous (IV) administered for Graft-Versus-Host Disease (GvHD)~     prophylaxis along with standard GvHD prophylaxis therapy (in participants undergoing~     allogeneic hematopoietic stem cell transplantation [allo-HSCT]).~   "
64044|NCT02728674|"~     This is a web-based randomized survey to evaluate management of respiratory symptoms among~     physicians in Sweden. The aim of this study is to determine if there is a gender bias in the~     diagnosis of COPD and how often physicians identify that chronic refractory breathlessness~     requires treatment as compared to refractory pain.~   "
64029|NCT02728869|"~     Rotaviruses are the leading cause of severe, dehydrating diarrhoea and related deaths in~     children aged less than 5 years worldwide and are reported to infect nearly every child by~     the age of 5 years. About 90% of all rotavirus-associated fatalities occur in low income~     countries in Africa and Asia and are related to poor health care. In view of high global RVGE~     burden, the World Health Organization (WHO) on 5th June 2009, recommended the inclusion of~     rotavirus vaccine in all the national immunization programs.~      Currently available rotavirus vaccines, RotaTeq® and Rotarix®, are WHO prequalified vaccines~     which are stable for recommended duration at storage temperature between 2-8 °C. However, if~     these vaccine are exposed to temperatures above 30 °C, the vaccine has to be discarded due to~     lost potency. It is very difficult to maintain the cold chain required to conserve the~     vaccine potency particularly in developing and low income countries, resulting in large~     amount of vaccine being wasted and in worst case scenario, endangering the lives of potential~     recipients. The WHO estimates that nearly half of freeze-dried and quarter of liquid vaccines~     are wasted each year. One of the biggest contributors to this wastage is disruption of the~     cold chain systems.~      Hilleman Labs new Rotavirus vaccine is a lyophilized heat stable rotavirus vaccine comprising~     of five live attenuated reassortant rotaviruses similar to RotaTeq®. The new heat stable~     rotavirus vaccine (HSRV) formulation offers a stability profile of 9 months at 45 °C and 12~     months at 37 °C. This new heat stable formulation (HSRV) could be transported in~     non-refrigerated supply chain significantly reducing the cost and complications associated~     with transporting vaccine to remote corners of the developing world. Heat-stable rotavirus~     vaccine (HSRV) has a potential to sustain high temperatures frequently encountered in regions~     where majority of rotavirus burden exists and has potential to partially or completely~     eliminate cold chain dependence.~      The current study has been designed to test for the first time in humans, the safety and~     tolerability of the new heat stable rotavirus vaccine (HSRV) in adults; followed by safety~     and immunogenicity in infants of age 6-8 weeks, as compared to the licensed RotaTeq® vaccine.~   "
64030|NCT02728856|"~     To evaluate the human eye irritation potential of two test sunscreen formulation~   "
64031|NCT02728843|"~     The goal of this study is to evaluate the effects of deferiprone, an iron-chelating drug, in~     patients with Parkinson's disease. Participants will be randomized to receive one of four~     different dosages of deferiprone or placebo, and will take the assigned study product twice a~     day for nine months.~   "
64032|NCT02728830|"~     The ultimate goal of the study is to identify potential biomarkers, immune gene expression~     signatures, and co-stimulatory pathways that may be used to understand the effect of immune~     checkpoint inhibitors on gynecologic cancers.~   "
64033|NCT02728817|"~     The Radial Artery Deviation And Reimplantation (RADAR) technique is a new approach for the~     construction of hemodialysis arteriovenous fistula. In this technique, the radial artery~     pedicle is deviated towards the minimally dissected cephalic vein at the wrist. The aim of~     this study is to compare the safety and efficacy of this technique with the traditional~     end-cephalic to side-radial arteriovenous fistula, currently used as a first line vascular~     access in hemodialysis patients.~      The hypothesis is that the minimal dissection concept used in the RADAR inhibits venous~     juxta-anastomotic neointimal hyperplasia and stenosis, and lead to higher rates of maturation~     and patency.~   "
64034|NCT02728804|"~     This clinical trial studies the use of the financial impact assessment tool in patients with~     colorectal cancer that has spread from the primary site to other places in the body.~     Gathering information about patients with colorectal cancer over time may help doctors better~     understand the financial impact of cancer and help patients avoid financial problems during~     treatment.~   "
64035|NCT02728791|"~     Correlation study between the data provided by two measurement systems, trans- pulmonary~     thermodilution and ClearSight © (non invasive), to determine the interest in routine use~     (cardiac output, cardiac index, stroke volume and blood pressure).~   "
64036|NCT02728778|"~     The main objective of the trial is to test whether a single application of botulinum toxin A~     into the glabellar region will lead to emotional stabilization in borderline personality~     disorder through paralysis of facial muscles/attenuation of negative emotions.~   "
64037|NCT02728765|"~     To study the frequency of obstructive sleep apnea (OSA) and continuous positive airway~     pressure (CPAP) treatment response in patients with non-alcoholic fatty liver disease~     (NAFLD).~      It is hypothesized that CPAP treatment may improve the activities of NAFLD in those with~     concomitant OSA.~      A screening study for OSA followed by a randomized controlled trial of patients with biopsy~     proven NAFLD being followed up at the hepatology clinic.~      Home sleep study, Epworth sleepiness score (ESS), paired proton magnetic resonance~     spectroscopy (MRS), transient elastography by fibroscan, serum cytokeratin-18 fragment, liver~     function tests and liver biopsy (only for those with fibroscan evidence of advanced liver~     fibrosis).~      Patients with confirmed symptomatic OSA will be randomized to receive auto CPAP or~     subtherapeutic CPAP as control over 6 months.~      Primary outcome: changes in intrahepatic triglyceride content (IHTG) measured by proton-MRS~     after 6 months of auto CPAP versus subtherapeutic CPAP.~   "
64038|NCT02728752|"~     Prospective, Double-blind, Randomized, Placebo-Controlled Phase III Study Evaluating Efficacy~     and Safety of Octagam 10% in Patients With Dermatomyositis (ProDERM study)~   "
64039|NCT02728739|"~     The purpose of this study is to determine the prevalence of moderate-to-severe Mitral~     Regurgitation (MR) in acute Heart Failure (HF) patients requiring hospital admission.~   "
64040|NCT02728726|"~     The study is designed to determine whether patients who receive sugammadex immediately after~     tracheal extubation will exhibit a decrease in the incidence of postoperative residual~     paralysis and an associated decrease in the incidence of postoperative respiratory~     depression.~   "
64041|NCT02728713|"~     The purpose of this study is to determine if there is a measurable change in visual function~     as a direct result of the application of osteopathic cranial manipulative medicine. The study~     will also attempt to determine whether any changes noted remain after withdrawal of the~     treatment.~   "
64042|NCT02728700|"~     This pilot phase I/II trial studies the side effects and how well sirolimus and mycophenolate~     mofetil work in preventing graft versus host disease (GvHD) in patients with hematologic~     malignancies undergoing hematopoietic stem cell transplant (HSCT). Biological therapies, such~     as sirolimus and mycophenolate mofetil, use substances made from living organisms that may~     stimulate or suppress the immune system in different ways and stop tumor cells from growing.~     Giving sirolimus and mycophenolate mofetil after hematopoietic stem cell transplant may be~     better in preventing graft-versus-host disease.~   "
64043|NCT02728687|"~     Treatments for painful diabetic peripheral neuropathy (PDPN) are not very effective and have~     multiple side effects. To find out if a menthol cream alone or with added mannitol treats~     PDPN effectively, 90 participants with PDPN, after one month of observation, will receive~     randomly assigned menthol cream or the same cream with mannitol added for 3 months with a~     crossover for 3 additional months. At time 0, 1,4 and 7 months their BPI pain severity and~     interference scores, DN4 scores, cream % effectiveness and side effects will be compared.~   "
64045|NCT02728661|"~     PACE is a patient-centered weight loss program that was developed specifically for knee~     replacements based on input from stakeholders, including knee replacement patients, physical~     therapists, and orthopedic surgeons. In this pilot study, participants undergoing knee~     replacement will be randomized to either start a weight loss program before surgery (PACE) or~     after surgery (Delayed PACE). Both programs will receive a 14-week intervention and complete~     assessments at baseline (up to 6 weeks prior to surgery), 12 weeks after surgery, and 26~     weeks after surgery.~   "
64046|NCT02728648|"~     Oxycodone has been in clinical use for decades. It is an effective alternative to morphine~     for moderate to severe acute or chronic pain and has been found to improve quality of life.~     The drug has been used parenterally or orally as perioperative analgesia or for cancer pain~     relief. Despite its long clinical experience, prescribing errors and misuse may lead to~     addiction and accidental overdose. Currently, little is known about the pharmacokinetic~     properties of intravenous oxycodone among paediatric patients in this region even though the~     drug has been used in children in other countries such as Finland. Therefore, a~     pharmacokinetic-pharmacodynamic study of oxycodone among Malaysian pediatric patients is~     warranted.~   "
64047|NCT02728635|"~     The purpose of this study is to collect data to help researchers better understand the~     different ways that women or men store fat (apple shape versus pear shape).~   "
64048|NCT02728622|"~     A randomized study of chemotherapy versus hormonal treatment in patients with ovarian cancer~     resistant or refractory to platinum and taxane.~   "
64049|NCT02728609|"~     The purpose of this study is to compare the pro-inflammatory and anti-inflammatory cytokines,~     protein content, and white blood cell (WBC) count present in the peritoneal fluid and plasma~     of trauma patients who undergo one of two different methods of open abdominal closure.~     Following analysis of the peritoneal fluid and serum samples, comparison of the results~     between the two groups will be completed and correlated with the overall organ function.~   "
64050|NCT02728596|"~     This randomized clinical trial studies prophylactic colony stimulating factor management in~     patients with breast, colorectal or non-small cell lung cancer receiving chemotherapy and~     with risk of developing febrile neutropenia. Patients receiving chemotherapy may develop~     febrile neutropenia. Febrile neutropenia is a condition that involves fever and a low number~     of neutrophils (a type of white blood cell) in the blood. Febrile neutropenia increases the~     risk of infection. Colony stimulating factors are medications sometimes given to patients~     receiving chemotherapy to prevent febrile neutropenia. Colony stimulating factors are given~     to patients based on guidelines. Some clinics have an automated system that helps doctors~     decide when to prescribe them when there is a high risk of developing febrile neutropenia.~     Gathering information about the use of an automated system to prescribe prophylactic colony~     stimulating factor may help doctors use colony stimulating factor when it is needed.~   "
64051|NCT02728583|"~     The main aim of the study is to investigate the effect of daily consumption of a margarine~     enriched with plant sterol esters and fish oil on fasting triglycerides (TG) concentrations.~      The study also aims to investigate the effect of plant sterols and fish oil on fasting total~     cholesterol (TC), Low-density lipoprotein cholesterol (LDL-C), High-density lipoprotein~     cholesterol (HDL-C) and non-HDL-C.~      At last, the effect of plant sterols and fish oil on fasting apolipoprotein concentrations~     will be explored.~   "
64052|NCT02728570|"~     The investigators have hypothesized that dietary flavonoids reduce insulin resistance and~     subclinical inflammation secondary to reductions in intestinal inflammation and permeability~     and that these events are mediated through alterations in gut microbiota composition. To test~     this hypothesis, 30 overweight/obese men and women will be provided two well-controlled diets~     that are identical in macronutrient content (Protein, 17% en; Fat, 30% en; Carbohydrate, 53%~     en), but differ markedly in flavonoid content (Low Flavonoid Diet, 10 mg/1000 Kcals; High~     Flavonoid Diet, 340 mg/1000 Kcals). All meals for both diets will be prepared and fed for 6~     weeks each in a randomized cross-over design with endpoints determined in duplicate during~     the last week of each diet period.~   "
64053|NCT02728557|"~     This study will assign patients to two types of psychotherapies in treating people with a~     major depression disorder, expressive versus supportive techniques, and will examine their~     ability to benefit from treatment based on their attachment orientation. This is a four month~     protocol, with a year follow up period, will compare patients receiving supportive-expressive~     treatment with either expressive focus or supportive focus.~   "
64054|NCT02728544|"~     Post exercise irisin levels in PWS patients Obesity, short stature, hypogonadism, hypotonia~     and impaired cognition are the major clinical features of Prader-Willi syndrome (PWS), a~     complex neurogenetic disorder due to lack of expression of paternal genes in the chromosomal~     region 15q11-13. Abnormal body composition with decreased muscle mass and increased fat mass~     contributes to low resting energy expenditure in PWS. Severe caloric restriction in the range~     of 800 kcal per day along with daily exercise regimens are needed to prevent weight gain and~     complications of obesity in this population.~      Brown adipose tissue (BAT) once thought to be present only in infants, but now known to be~     present in adults as well, differs from the more abundant white adipose tissue (WAT) by~     dissipating energy through thermogenesis as a result of increased activity of the~     mitochondrial uncoupling protein (UCP-1). Recently evidence shows that exercise activates~     mitochondrial UCP-1 in subcutaneous WAT cells resulting in conversion of WAT to BAT-like~     adipocytes (Beige or BRITE adipose tissue). Various factors including natriuretic peptides,~     interleukin-6 and myokines (irisin, fibroblast growth factor 21, and ß-aminoisobutyric acid)~     appear to mediate the effects of exercising muscle on subcutaneous adipocytes.~      Decreased amount and/or activity of BAT might contribute to the lower energy expenditure and~     extreme difficulty in weight-control in PWS. Lower levels or decreased myokine production~     could result in failure to convert subcutaneous WAT to Beige or BAT-like adipocytes, and~     therefore minimize or negate the otherwise beneficial metabolic effects of exercise. Direct~     measurement of peak oxygen uptake in PWS adults show that this population has markedly lower~     VO2 values compared with normal BMI-matched controls. BAT activity in vivo can be accurately~     measured only by performing PET/CT scans which include administrating radioactive tracers.~     For ethical reasons, direct assessment of BAT is not possible for purposes of clinical~     research in PWS individuals.~      The investigators propose to study humoral responses to exercise in 16 (8 males) PWS~     adolescents and young adults and compare results with responses in a similar number of sex,~     age, and BMI-matched controls. At an initial one-hour meeting study participants will learn~     to perform aerobic (treadmill) exercise and resistance training under the supervision of an~     experienced exercise physiologist. Exercise intensity will be assessed by direct measurement~     of VO2 max. On a different day, a blood sample will be drawn before and immediately at the~     conclusion of the same exercise regimen. Blood samples will be assayed for irisin,~     interleukin-6, atrial natriuretic peptide, FGF-21, in addition to glucose, growth hormone,~     cortisol, norepinephrine, and lactate.~      The investigators hypothesize that PWS participants will show weaker humoral responses to~     similar exercise regimens compared to normal control subjects. Data showing lower levels of~     myokines, such as irisin, following exercise in PWS might suggest that inadequate conversion~     of WAT to BAT-like adipocytes in subcutaneous adipose tissue results in decreased~     thermogenesis and abnormally low energy expenditure in this population. Potentially,~     development of pharmacologic agents which mimic irisin or other myokines by activating UCP-1~     and converting WAT to BAT-like adipocytes could offer a new approach to weight-control in PWS~     individuals.~   "
64055|NCT02728531|"~     Given the established role of high dose cytarabine (HiDAC) combined with rituximab, along~     with recent data showing the encouraging efficacy of bendamustine, the investigators seek to~     integrate the synergistic effects of these medicines in alternating cycles as induction~     therapy prior to autologous stem cell transplant (ASCT). Based on prior experience with~     bendamustine and rituximab (BR) based induction therapy, the investigators seek to evaluate~     the efficacy and safety of stem cell mobilization in this pilot study~   "
64056|NCT02728518|"~     The investigator's goal in this study is to evaluate the efficacy and safety of nebulized~     amikacin versus intravenous amikacin in patients with hospital and ventilator acquired~     pneumonia in surgical patients admitted to the intensive care units infected with gram~     negative bacilli~   "
64057|NCT02728505|"~     Single-center, prospective, placebo controlled trial of tolerability and safety of~     low-concentration SinuSurf sinus irrigation solution in normal subjects. Forty (40) healthy~     subjects aged 18-65 will be enrolled in the study.~   "
64058|NCT02728492|"~     Quisinostat besides its own efficacy, which can potentially lead to better results of~     polychemotherapy and increase the mean time to progression, it may be demonstrated that~     Quisinostat leads to sustained tumor sensitivity to platinum drugs. In this study safety and~     tolerability of multiple administrations of Quisinostat in doses ranging from 8 mg to 12 mg~     combined with standard backbone chemotherapy in patients with non-small cell lung cancer~     (second line) and ovarian cancer (second and subsequent lines) will be investigated.~   "
64059|NCT02728479|"~     Percutaneous transluminal angioplasty (PTA) is a minimally invasive procedure for dilating~     blood vessels in the treatment of peripheral artery disease.~      The aim of this registry is to collect prospectively and systematically clinical research~     data from patients undergoing PTA. This registry is an open-end observational study to assess~     the characteristics and outcomes in patients with undergoing PTA.~   "
64060|NCT02728466|"~     There is a question regarding the role of higher flavanol oligomers (procyanidins) and of~     intestinal flavanol metabolites i.e. valerolactones, in the context of flavanol~     intake-related vascular effects. Only flavanol monomers, and to a certain degree dimers, are~     absorbed in the small intestine and enter circulation. Higher oligomers (procyanidins) are~     not absorbed and are catabolized by the colonic microflora. The catabolites enter the~     circulation. Phenolic acids and valerolactones represent a significant proportion of these~     catabolites, reaching peak concentrations in the order of 6-10 h post ingestion. The vascular~     effects of these colonic microbiome-derived flavanol derivatives have not been studied so~     far. The purpose of the study is to determine the timecourse of endothelial function along~     with flavanol catabolites & metabolites during acute, sustained, and acute on sustained~     ingestion of procyanidins as compared to previously used flavanol interventions, and flavanol~     free control.~   "
64061|NCT02728453|"~     Patients with type 2 diabetes mellitus are exposed to an excessive heart failure risk~     secondary to left ventricular hypertrophy and impaired diastolic filling, a condition not~     addressed by currently available treatments. The abnormality results from obesity-induced~     volume overload, increased blood pressure, and myocardial fat accumulation. By improving~     metabolism, body weight, and blood pressure, Empagliflozin addresses the root causes of type~     2 diabetes-associated myocardial disease. We will assess left ventricular mass, function, and~     lipid content in patients with type 2 diabetes mellitus using cardiac magnetic resonance~     imaging and spectroscopy as well as echocardiography before and after empagliflozin or~     glimepiride treatment. We expect to observe improvements in left ventricular mass, function,~     and fat content with empagliflozin. The results of the study will help to position~     empagliflozin as an antidiabetic agent with the added value of protecting the heart.~   "
64062|NCT02728440|"~     Effects of gonadotrophin replacement therapy Lipid Profile and Oxidative Stress Parameters of~     Patients with Idiopathic Hypogonadotropic Hypogonadism~   "
64063|NCT02728427|"~     Compared with traditional open proctectomy, laparoscopic surgery is associated with less~     pain, earlier recovery, and better cosmetic outcome, and its long-term oncologic outcomes~     have been demonstrated. However, the rate of urinary dysfunction after rectal cancer surgery~     was about 19-38% because of mesorectal excision. The type of drainage is unclear. Some~     studies show that the rates of urinary tract infection, second catheterization, and urinary~     symptom are lower with suprapubic catheterization (SPC) than with transurethral~     catheterization (TUC). Moreover，SPC allows for testing the bladder voiding without drainage~     removal. Furthermore，SPC using central venous catheter(CVC) is less invasive.~      Currently, there is lack of randomized controlled trial(RCT) to compare SPC with TUC.~     Therefore, investigators perform this prospective randomized trial to compare SPC using CVC~     with TUC in laparoscopic surgery for rectal cancer.~   "
64064|NCT02728414|"~     The purpose of this study is to determine whether the probiotics is effective in the~     treatment of type 2 diabetes.~   "
64065|NCT02728401|"~     The aim of this investigation is to longitudinally quantify host gene expression and serum~     proteins in children with infectious and non-infectious SIRS. The investigators hypothesize~     that children with non-infectious SIRS, with bacterial infection associated SIRS, or with~     viral infection associated SIRS will exhibit distinct patterns of host gene expression and~     serum proteins. The investigators further hypothesize that it should be possible to discover~     sets of mRNA or protein biomarkers that will permit unambiguous diagnosis of non-infectious~     SIRS, SIRS associated with bacterial infection, and SIRS associated with viral infection.~   "
64066|NCT02728388|"~     The investigators wish to determine the time to disease progression for benign neurofibromas~     treated with Levulan Kerastick topical photosensitizer and red light photodynamic therapy~     (PDT) in patients with neurofibromatosis type 1 (NF1).~      The investigators also wish to measure tumor size for control and treatment tumors in order~     to gain insights into tumor growth rates.~   "
64067|NCT02728375|"~     This research project focuses on the evaluation of an engaging exercise and cognitive~     computer game-based platform and embedded assessment tools for use in clinical practice and~     its transition to use in the home, and elementary classrooms. The goal of our research~     program is to produce innovative therapeutic point-of-care and cost-effective delivery system~     leading to better long-term health outcomes for toddlers and children with neurodevelopmental~     disabilities. The program is grounded on our technological developments and on current~     research documenting the benefits of computer-aided learning tools, exercise gaming~     applications in rehabilitation and principles of adaptive learning and neuroplasticity. We~     will conduct a randomized controlled trial to study the feasibility and effectiveness of a~     computer-aided, game-based repetitive task practice (RTP) program designed for training of~     fine and gross motor skills of the hand-arms and psychomotor skills (which) in young children~     with CP.~   "
64068|NCT02728362|"~     To investigate the functional outcomes and prevalence and severity of knee pain for patients~     undergoing suprapatellar nailing of tibial shaft fractures.~   "
64069|NCT02728349|"~     The purpose of this study:~      Determining the Maximum Tolerated Dose (MTD), Dose-Limiting Toxicity (DLT), pharmacokinetics~     characteristic, and dosage regimen of phase II/III of Chlorogenic acid for injection in the~     advanced Glioblastoma Patients ;~   "
64070|NCT02728336|"~     The goals of this project are to: 1) explore the potential use of magnetic resonance imaging~     (MRI) data for improved prediction of response to cardiac resynchronization (CRT), and 2) use~     the MRI-derived data together with a computer model of the cardiovascular system to study the~     relative roles of different factors in the mechanical effects of dyssynchrony in failure, and~     in the response (or lack thereof) to CRT.~   "
64071|NCT02728323|"~     In many countries, caesarean section (CS) rates have been increasing. The international~     literature is unclear regarding the analgesic efficacy of the transversus abdominis plane~     block (TAPB) after a CS. In particular, no clinical trials exist in which the correct method~     of performing this block has been matched with the obtained analgesic effect after a CS. The~     primary goal of the study was to determine whether a correctly performed ultrasound-guided~     TAPB (USG-TAPB) could provide patients who underwent a CS with better control of acute~     postoperative pain during the first 72 hours after surgery~   "
64072|NCT02728310|"~     The combination of subarachnoid anaesthesia (SAB) and continuous local wound infiltration~     (LCWI) with a consistent amount of local anaesthetics could prevent central sensitization~     through an additive or synergistic effect because it can maintain continuous inhibition of~     nociceptive afferents~   "
64074|NCT02728284|"~     The purpose of this investigation is to evaluate newer methods of performing cardiovascular~     MRI (CMR) that will provide new kinds of information related to the interplay between the~     cardiac and the respiratory cycles, such as the interaction between the left ventricle and~     the right ventricle during respiration . The primary statistical objective is to provide~     preliminary indications of the relative utility of the investigational imaging software in~     terms of image quality and suitability for routine clinical use. Image quality will be~     expressed in terms of signal-to-noise ratios (SNR), contrast-to-noise ratios (CNR) and~     subjective Likert-type qualitative assessments independently provided by each of multiple~     blinded readers for each image. Suitability for routine use will be assessed in terms of~     imaging time and a binary indicator of whether, in the opinion of the investigator, adverse~     procedural complications (not expected) were encountered during a given imaging session.~   "
64075|NCT02728271|"~     Churg-Strauss syndrome is a rare autoimmune inflammatory disease affecting medium- and~     small-sized blood vessels, causing asthma, abnormalities of the blood, lung diseases, and~     neuropathy. The main cause of death in these patients is heart attack. Without therapy, the~     5-year survival in patients with Churg-Strauss syndrome is 25%. Although with the 5-year~     survival is increased to 62% with the appropriate therapy, many patients remain refractory to~     therapy. The long term outcome of these patients remains grim.~      The aim of this research study is to determine if suppressing the immune system using a~     combination of high dose chemotherapy, antibodies, and radiation followed by stem cell~     transplant will abolish the 'bad' immune system and let the patient's body establish a new~     immune system that does not attack the blood vessels.~   "
64076|NCT02728258|"~     This phase II trial studies how well copanlisib works in treating patients with endometrial~     cancer that has not decreased or disappeared, and the cancer may still be in the body despite~     treatment (persistent) or has come back (recurrent). Copanlisib may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth.~   "
64077|NCT02728245|"~     Randomized phase 2 trial comparing preoperative dienogest therapy followed by surgery vs.~     upfront surgery to save ovarian reserve in young women with ovarian endometrioma~   "
64078|NCT02728232|"~     This trial is set to detect the impact of bilateral internal iliac artery ligation on the~     amount of intra-operative blood loss during the hysterectomy procedure done for the~     management of abnormally invasive placenta~   "
64079|NCT02728219|"~     The purpose of this study is to compare the treatment of recurrent hepatocellular carcinoma~     with repeat hepatectomy,and transcatheter arterial chemoembolization (TACE) with AFP~     conversion.~   "
64080|NCT02728206|"~     This study will evaluate the antiviral efficacy, safety, and tolerability of~     sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in hepatitis C virus~     (HCV)-infected adults who are undergoing liver transplantation.~   "
64081|NCT02728193|"~     The aim of our study was to elucidate the difference in the rates of complication,~     hospitalization days, medical expenses, MRI showed that the degree of tumor necrosis, and~     overall survival rates of the therapies between PEI, MVA and RFA, and make the standard for~     minimally invasive treatment of very early stage HCC.~   "
64082|NCT02728180|"~     The main purpose of this trial is to determine whether Xingnaojing, intravenously~     administered within 24 hours of symptom onset, improves the 3-month outcome in participants~     with acute ischemic stroke.~   "
64083|NCT02728167|"~     The purpose of this study is to evaluate whether HIFU-assisted liver resection (HIFU-AR)~     results in reduced blood loss compared to standard liver resection in patients with LM.This~     is a prospective, monocentric, randomized (1:1 ratio), comparative, open-label Phase II~     study.~   "
64084|NCT02728154|"~     Gut microbiota play an important role in normal cardiovascular function and pathophysiology~     of cardiovascular diseases. Patients with heart failure (HF) have substantial hemodynamic~     changes which lead to intestinal hypoperfusion and congestion and eventually change gut~     morphology, permeability, function and composition of gut microbiota and cause translocation~     of microbial and endotoxins into the blood stream. Additionally, metabolites derived from gut~     microbiota modulate the pathophysiology of HF. Patients with HF have intestinal overgrowth of~     pathogenic bacteria and increased gut permeability. Accumulating evidence demonstrates that~     antibiotic treatment benefits patients with acute coronary syndromes and reduces the~     incidence of ischemic cardiovascular events. Taking the strong association of gut microbiota~     with HF into account, it is reasonable to speculate that gut microbiota could contribute to~     the progression of pre-HF with preserved ejection fraction (pre-HFpEF) to HF with preserved~     ejection fraction (HFpEF). Pre-HFpEF remains poorly understood, yet has high prevalence and a~     significantly high risk for death in comparison to patient without pre-HFpEF. We hypothesize~     that altered gut microbiota is involved in the initiation and establishment of HF and~     pre-HFpEF.~   "
64085|NCT02728141|"~     Iron deficiency affects the opioid and dopamine systems in rodent models, with a higher pain~     threshold. The opioid system is involved in sucrose's ability to reduce pain and distress~     during neonatal procedures. Thus, prenatal iron deficiency might affect response to pain and~     sucrose analgesia. In order to compare response to pain and sucrose during heel stick in~     neonates with and without iron deficiency, healthy full-term Chinese infants were randomized~     to receive sucrose or water by syringe beforehand, in conjunction with heel stick for~     metabolic screening.~   "
64086|NCT02728128|"~     The purpose of this study is to identify if circulating platelet cyclic adenosine~     monophosphate (cAMP) levels can be used as a biomarker of milrinone efficacy in children~     following cardiac surgery or undergoing heart transplant.~   "
64087|NCT02728115|"~     Cellavita HD is a stem-cell therapy for Huntington's Disease. This is a first-in-human, dose~     escalation study in which participants with Huntington's Disease will receive 3 intravenous~     injections and will be followed for 5 years to evaluate safety and preliminary evidence of~     effectiveness.~   "
64088|NCT02728102|"~     The study is designed as a Phase II, multicenter trial of vaccination with Dendritic~     cell/myeloma fusions with granulocyte macrophage colony-stimulating factor (GM-CSF) adjuvant~     plus lenalidomide maintenance therapy versus maintenance therapy alone or with GM-CSF~     following autologous transplant as part of upfront treatment of multiple myeloma (MM). It is~     hypothesized that the dendritic cell myeloma vaccine will result in improved response in~     patients with multiple myeloma after autologous Hematopoietic Cell Transplant (HCT).~   "
64090|NCT02728076|"~     This study examines the feasibility to deliver accelerated partial breast irradiaiton (APBI)~     before a lumpectomy is performed. By administering the APBI before the lumpectomy, a smaller~     volume of breast tissue may be exposed to radiation. The APBI method used in this study is 3D~     (three dimensional) conformal external beam irradiation. 3D-conformal external beam~     irradiation uses an X-ray beam to deliver the radiation dose. Traditionally, CT imaging is~     used to plan treatment. In this study, an MRI will be used. Approximately five to eight weeks~     after completion of the APBI, the cancer will be surgically removed.~   "
64091|NCT02728063|"~     The main objective of the study is to evaluate the effect on intestinal permeability of a~     supplementation with Lactibiane Tolérance® for 4 weeks (28 days) in patients suffering from~     irritable bowel syndrome (IBS) with diarrhea predominance.~      Secondary objectives of the study are to evaluate the effects of supplementation with~     Lactibiane Tolérance® for 4 weeks (28 days) in patients suffering from IBS with diarrhea~     predominance on intestinal permeability, inflammation of the digestive tract, symptoms and~     comfort.~      Single-center study in single open arms: 30 volunteer adults suffering from Irritable Bowel~     Syndrome (IBS) with diarrhea predominance and matching the criteria of inclusion and~     non-inclusion listed below.~   "
64092|NCT02728050|"~     This phase I/II trial studies the side effects and best dose of filgrastim (granulocyte~     colony-stimulating factor [G-CSF]), cladribine, cytarabine, and mitoxantrone hydrochloride,~     when given together with sorafenib tosylate and to see how well they work in treating~     patients with newly-diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome~     (likely to be more aggressive). Drugs used in chemotherapy, such as filgrastim, cladribine,~     cytarabine, and mitoxantrone hydrochloride work in different ways to stop the growth of~     cancer cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Sorafenib tosylate may stop the growth of cancer cells by blocking some~     of the enzymes needed for cell growth. Giving filgrastim, cladribine, cytarabine, and~     mitoxantrone hydrochloride together with sorafenib tosylate may kill more cancer cells.~   "
64093|NCT02728037|"~     This study will be a randomized, controlled, double-blinded, single-centre superiority trial~     with two parallel groups. The primary outcome will be average myofascial pelvic pain in the~     two weeks following final injection treatment as assessed using the visual analogue scale.~     Randomization will be performed as block randomization with a 1:1 allocation ratio,~     stratified based on opioid use at the time of study enrollment. In total, 60 participants~     will be recruited and randomized, with 30 being assigned to each treatment arm. The study~     will be restricted such that none of the participants enrolled will be current concomitant~     opioid users (for any reason) and will not have used opioid drugs within the 3 months~     preceding enrollment in the study.~      A third non-randomized arm of 30 participants who are on the waiting list for the chronic~     pain clinic will be enrolled and compared to the two randomized arms. Among this patient~     population and in the setting of the Chronic Pain Clinic it was determined that it would not~     be acceptable to randomize participants to a no-treatment control group. As such, an active~     treatment is being used as comparator in the randomized trial. In order to assess~     participants in the absence of treatment this third non-randomized arm will serve as a~     no-treatment control group.~      Eligibility criteria for this third arm is the same as the main study, except for the~     restriction by opioid use status. Participation in this third arm will not exclude a~     participant from randomization into one of the two main arms of the study. Therefore, across~     the three arms, up to 90 patients will be enrolled in this study.~   "
64094|NCT02728024|"~     The study is undertaken at three German neurosurgical centers (Ulm, Mainz, Stuttgart) between~     March 2014 and March 2015. Inclusion criteria were age ≥ 18 and ≤ 80, diagnosis of glioma~     WHO° II-IV, absence of aphasia impairing communication or consent. In an outpatient setting~     all eligible patients with gliomas were screened for distress (Distress Thermometer (DT)) and~     their need for psychosocial support (Supportive Care Needs Survey-SF34-G (SCNS)).~     Simultaneously their HRQoL was assessed (EORTC QLQ-C30+BN-20 Vers. 3).~      Patients at different disease stages were asked to fill out the questionnaires. At two study~     centers patients were asked to complete the questionnaires prior to their appointment with~     personal instructions in randomly selected cases. At the third study center, they completed~     the questionnaires after their outpatient appointment with personal aid and instructions. At~     the time of investigation, patients were at different stages of treatment (chemotherapy,~     radiation, re-chemotherapy, re-radiation, none, etc.).~   "
64095|NCT02728011|"~     The purpose of this study was to examine the feasibility and efficacy of computerized~     cognitive exercises from Scientific Brain Training (SBT), compared to the computer game~     Tetris as an active placebo, in a pilot study of adolescents with~     Attention-deficit/hyperactivity disorder (ADHD).~   "
64096|NCT02727998|"~     The purpose of this study is to combine a single infusion of Ketamine with 7-days of trauma~     focus psychotherapy to relieve post traumatic stress disorder (PTSD) symptoms more~     effectively. This treatment has the potential to produce a significant therapeutic effect~     that otherwise would take months to occur.~   "
64097|NCT02727985|"~     The primary purpose of this study is to compare opioid use post-spinal cord stimulation~     implant at 1, 3, 6, 9 and 12 month intervals in patients who were provided with a weaning~     schedule by the Neuromodulation team (experimental group) versus those who wean on their own~     or with their family doctor (control group; standard care) to determine if one strategy is~     superior to the other.~      The secondary objectives will be to further characterize change in opioid use as it relates~     to pain scores, quality of life and disability from baseline to follow-up assessments. The~     investigators will examine changes in opioid-related adverse events and medication costs to~     help understand the impact of opioid weaning on the patient and the system. The investigators~     will also compare worker's compensation patients with non-worker compensation patients to see~     if they follow the same result pattern.~   "
64098|NCT02727972|"~     This research study is designed to look at the involvement of the glutamate system in~     depression. Each subject will undergo a screening appointment to determine study eligibility.~     Thereafter, the study will take 2 or 3 visits depending on schedule availability and will~     consist of one MRI scan, and PET scan. Subjects will also participate in cognitive testing.~     Depending on camera time, staff availability and subject schedule, total study participation~     may last 1-2 months.~   "
75875|NCT02573805|"~     The purpose of this study is to evaluate the diagnostic value of Rigiscan (nocturnal penile~     tumescence and rigidity, NPTR ) test in erectile dysfunction of Chinese males.~   "
64099|NCT02727959|"~     The IBSEN III study will investigate the incidence of inflammatory bowel disease in South~     Eastern Norway and describe the clinical course of the disease. The investigators will map~     newly diagnosed and treatment naive IBD patients at various levels (epidemiological,~     clinical, psychosocial and nutritional as well as immunological, genetic, epigenetic and~     microbial) as a basis to improve targeted and individualized treatment and care. The~     investigators will include incident IBD patients at all local- and university hospitals in~     the South Eastern Health Region in 2016-2018 and follow-up prospectively for five years. The~     investigators will use standardized and validated registration methods allowing comparability~     with previous national and international IBD cohorts, link data to national health registries~     and collect blood, feces and biopsies for bio banking.~   "
64100|NCT02727946|"~     Early intervention and resuscitation based upon a lot of clinical, laboratory findings make a~     big difference regarding outcome in poly trauma patients, the study uses the dynamic lactate~     change and the difference between arterial and venous CO2, oxygen tension or content as~     indicators for tissue perfusion.~   "
64101|NCT02727933|"~     The primary objective of this study is to describe the safety of the combination of Daklinza~     (daclatasvir) and Sunvepra (asunaprevir) when used for the treatment of chronic hepatitis C~     (CHC) genotype 1b patients in real-life conditions when used according to its registered~     indications.~   "
64102|NCT02727920|"~     This study is designed to test the efficacy of energy drinks. This is a double-blinded,~     crossover, randomized clinical trial, measuring the effect of the test drinks compared with~     placebo drink in 200 participants aged 18-70 years.~   "
64103|NCT02727907|"~     Study design is double-blind, randomized, placebo-controlled study in 3 parallel groups with~     the use of active comparator and placebo. Total duration of therapy of about 2 years. Study~     hypothesis is equivalence of efficacy and safety of the investigational drug BCD-033 original~     drug Rebif®.~   "
64104|NCT02727894|"~     The purpose of this study is to determine whether colorectal cancer diagnosed by screening~     (primary screening colonoscopy, colonoscopy after FOBT) has a better pTNM classification than~     colorectal cancer diagnosed byl other diagnostics (diagnostic colonocopy, CT, MR etc.).~   "
64105|NCT02727881|"~     A Phase 3 Study of the Efficacy and Safety of Squalamine Lactate Ophthalmic Solution 0.2%~     Twice Daily in Subjects with Neovascular Age-Related Macular Degeneration. Patients will~     receive injections of ranibizumab. In addition, patients will receive either Squalamine~     lactate 0.2% eye drops or Placebo eye drops. The study duration is approximately 9 months to~     primary endpoint~   "
64106|NCT02727868|"~     The evaluation of the impact of environment on the incidence of cancer is a major public~     health issue. Increased knowledge in this area is necessary for the implementation of primary~     prevention means with appropriate preventive measures but also to the implementation of~     secondary prevention measures with targeted screening actions.~      Among the environmental exposures that may lead to cancer, mutagenic environments are of~     major importance, and the causal link between environmental genotoxicity and cancer has been~     established for a long time. It is also well established that susceptibility to mutation is~     highly variable among individuals. This is explained by genetic polymorphisms of genes~     involved in metabolism and in genome stability.~      The identification of biomarkers of exposure to mutagenic environments is necessary for~     assessing the impact of an environment in humans. Some studies in animals have shown that the~     PIG-A gene may be a biomarker of exposure to a mutagenic environment. In particular, a~     significant increase in erythrocyte PIG-A mutants has been demonstrated in rats after a~     genotoxic exposure to cisplatin, but it has so far not been evaluated in humans. One study of~     healthy volunteers shows that the frequency of PIG-A mutated cells in humans can be estimated~     efficiently and reliably.~      The PIG-A gene meets all the necessary criteria for a sentinel gene for tracking of~     spontaneous somatic mutation frequency or induced a mutagenic environment: ubiquitous~     expression, phenotypic change linked to a mono-allelic mutation viability of mutated cells ,~     spectrum off inactivating mutations (deletions, substitutions, chromosomal rearrangements).~     Finally, the detection of the disappearance of glycosylphosphatidylinositol on the plasma~     membrane is easily achievable by flow cytometry.~   "
64107|NCT02727855|"~     To evaluate the preventive impact, demand, acceptability, uptake, feasibility, and~     cost-effectiveness of a two-dose regimen of the OCV Shanchol in children living in urban~     slums in Bangladesh, Investigators will conduct a targeted mass immunization programme, using~     an innovative approach successfully deployed by the Bangladesh government in its recent~     countrywide campaign of MR vaccination of 52 million children aged 9 months to 14 years (<15~     years). Investigators will undertake a census of a geographic population of approximately~     300,000 persons, with GIS locations of each household. This census will be updated every 6~     months during the follow-up period to permit tracking of births, deaths, and migrations,~     including changes in location of each individual's residence. Following the initial census,~     the OCV will be offered to all non-pregnant individuals aged 1 to 14 years. Operational~     research and economic studies will evaluate the coverage, feasibility, acceptability, demand,~     costs and cost-effectiveness of this vaccination programme.~   "
64108|NCT02727842|"~     Studying usability and gaining feedback of the CP950 Sound Processor in experienced cochlear~     implant recipients.~   "
64109|NCT02727829|"~     The aim of the present study is to assess the effects of brachial plexus block on~     microcirculation using pefusion index and capillary filling time.~   "
64110|NCT02727816|"~     The aim of this non-dispensing study is to evaluate the clinical performance of different~     hydrogel contact lens designs.~   "
64135|NCT02727491|"~     With Institutional ethics board and Health Canada approval, pediatric patients (ages 3-12)~     undergoing tonsillectomy or adenotonsillectomy (under standardized anesthesia) will be~     randomized to receive dextromethorphan hydrobromide (1mg/kg orally) 30 min preoperatively and~     again 8 hours postoperatively OR placebo (syrup identical in taste, appearance and volume) at~     the same time points. The primary outcome is an integrated assessment of perioperative pain~     scores and opioid use for 24 hours postoperatively. Secondary outcomes include nausea,~     vomiting, respiratory depression, and bleeding for 24 hours postoperatively. Our hypothesis~     is that dextromethorphan will decrease the incidence/severity of post-tonsillectomy pain. The~     improved pain control will be apparent through reduced opioid consumption and integrated pain~     scores. This will result in a reduced incidence of opioid-related side effects and adverse~     events.~   "
64111|NCT02727803|"~     The goal of this clinical research study is to learn if giving cells called natural killer~     (NK) cells after receiving 1 of 3 pre-treatment plans and a UCB transplant can improve~     response in patients with MDS, leukemia, lymphoma, or MM. The safety of this treatment and~     whether NK cells can lessen the risk of graft versus host disease (GVHD) will also be~     studied.~      If the disease is CD20 positive, you will also receive rituximab on this study in addition to~     what is described above. CD20 is a type of marker for white blood cells. White blood cells~     help protect the body from infections.~      NK cells may kill cancer cells that remain in your body after your last chemotherapy~     treatment. The NK cells will be separated from umbilical cord blood. The device used in the~     laboratory to separate the NK cells is called a CliniMACS. These separated NK cells will then~     be grown in the lab to increase the number of NK cells that can be given to you by vein.~      Based on your genes, your NK cells may not recover as quickly after transplant. Before the~     transplant, blood will be collected for genetic testing as part of standard screening tests.~     If the genetic test shows that your NK cells will not recover as quickly after transplant,~     you will receive the NK cell infusion.~      This is an investigational study. Busulfan, fludarabine, clofarabine, ATG, rituximab,~     cyclophosphamide, mesna, and melphalan are FDA approved and commercially available for the~     treatment of blood cancers and/or for use in stem cell transplant. The way the researchers~     process the NK cells and the way they are infused is not FDA approved. These processes are~     currently being used for research purposes only.~      Up to 100 participants will be enrolled in this study. All will take part at MD Anderson.~   "
64112|NCT02727790|"~     The epidemic nature of type 2 diabetes mellitus, along with the downsides of current~     treatments, has raised the need for therapeutic alternatives. The aim of this study is to~     evaluate safety, tolerability, and the glucose-lowering effect of noninvasive peripheral~     electrical stimulation (PES) as an alternative treatment for diabetes.~   "
64113|NCT02727777|"~     The goal of this clinical research study is to learn if TAK-228 can help to control relapsed~     lymphoma. The safety of this drug will also be studied.~   "
64114|NCT02727764|"~     This study will evaluate the safety and tolerability of a single intra-articular~     administration of ART-I02 (AAV5.NF-kB.IFN-β), a recombinant adeno-associated virus (AAV) type~     2/5 vector in subjects with Rheumatoid Arthritis (RA) or Osteoarthritis (OA) and active~     arthritis of the carpometacarpal (CMC), metacarpophalangeal (MCP), proximal interphalangeal~     (PIP), or distal interphalangeal (DIP) joints.~   "
64115|NCT02727751|"~     This phase 3, open label study will evaluate the safety of tenapanor 50 mg BID in subjects~     with constipation-predominant irritable bowel syndrome (IBS-C) defined by the ROME III~     criteria. Subjects who have completed either TEN-01-301 (16 weeks) or TEN-01-302 (26 weeks)~     studies may be enrolled. Subjects will take tenapanor for approximately 52-55 weeks total~     based on previous protocol and this study.~   "
64116|NCT02727738|"~     Evaluation of the efficacy of the combined treatment (methimazole plus selenium) in the~     control of hyperthyroidism as compared to methimazole alone in 30 Graves' disease (GD)~     untreated patients.~   "
64117|NCT02727725|"~     -  The purpose of this study is to show that the novel TRAMINER (T(Rho) and Magnetization~          Transfer and Inversion Recovery) sequence provides at least as good visualization and~          detection of sub-endocardial scarring, fibrosis, and acute infarction as the current~          gold standard Inversion Recovery (IR) Turbo-Flash sequence.~        -  The hypothesis is that the TRAMINER sequence has the same or higher sensitivity in~          detecting small sub-endocardial scarring than the inversion recovery segmented gradient~          echo sequence known as IR-Turbo Fast low angle shot (IR Turbo-Flash), which is the~          accepted current gold standard for the detection of myocardial viability.~   "
64118|NCT02727712|"~     This study intends to compare the combination of general anesthesia (GA) and single-shot~     bilateral thoracic paravertebral block (TPVB) by ropivacaine in the patients undergoing~     off-pump coronary artery bypass surgery ( OPCAB) with traditional general anesthesia (GA)~     perioperative management of patients, committed to reducing patient's physical and~     psychological stress by surgical trauma, achieve the purpose of fast recovery, in order to~     establish an more effective perioperative management during off-pump coronary artery bypass~     surgery, improve patients' satisfaction and to accelerate postoperative rehabilitation~     safely.~   "
64119|NCT02727699|"~     This XanADu Phase II study in mild Alzheimer's Disease (AD) is to assess the safety,~     tolerability and efficacy of Xanamem™ in subjects with mild dementia due to Alzheimer's~     Disease. Subjects will be randomized to receive either 10mg once daily Xanamem™ or Placebo at~     a 1:1 ratio in a double-blinded fashion.~   "
64120|NCT02727686|"~     Delayed post-operative hyponatremia occurs in 5-20% of patients following pituitary surgery~     and typically occurs on post-operative day 5-10.This decline in sodium can occur rapidly and~     have serious consequences such as altered mental status, seizures, coma, and even death.~     Despite significant research into patient demographics and risk factors, the investigators~     have not been able to predict which patients will suffer from delayed post-operative~     hyponatremia to date. At the Barrow Neurological Institute, physicians currently utilize an~     outpatient screening protocol to monitor patients' sodium levels after surgery, but this has~     yet to be effective for reducing readmissions following pituitary surgery. The etiology of~     delayed post-operative hyponatremia has been linked to water and sodium dysregulation in the~     post-operative period. It has been shown that post-operative day 1-2 sodium levels are~     statistically lower in patients who develop delayed hyponatremia, however, the numerical~     differences are not large enough to guide clinical management. The investigators propose that~     a water load on post-operative day 1 may expose underlying sodium/water dysregulation in the~     early post-operative period. This would improve physicians' understanding of the~     pathophysiology of post-operative hyponatremia, and it may help to serve as a screening tool~     for these patients in the future.~   "
64121|NCT02727673|"~     The aim of this study is to establish a platform of detecting and sorting circulating tumor~     stem cells from peripheral blood in HCC patients; to investigate the relationship between~     circulating tumor stem cells and their effects on postoperative recurrence and metastasis, in~     order to provide a new therapeutic target for hepatocellular carcinoma treatment.~   "
64122|NCT02727660|"~     This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD~     exacerbation and lung function study with PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6~     μg, all administered BID.~   "
64123|NCT02727647|"~     Title: Comparison of different prophylaxis regimens for hemophilia A pediatric patients~     Principal Investigator: Assistant Professor Darintr Sosothikul, MD Research Question: Does~     different factor VIII dosage effect outcome of hemophilia treatment in term of breakthrough~     bleeding, number of hospital stay and day-off from school? Type Research: Clinical research~      Study design: Single center clinical trials~      Concise methodology:~        1. Study Population: Children with hemophilia A who received treatment at KCMH from May~          2015 to March 2016 will be enrolled in this study. The consent will be obtained before~          the study.~        2. Observation and measurement:~             1. History, interesting clinical data and laboratory data will be recorded in Clinical~               record Form (CRF)~             2. Measurement:~           i. Complete blood count (CBC), Factor VIII level, Factor VIII inhibitor level ii. Number~          of breakthrough bleedings, number of hospital stay and day-off from school iii. Joint~          score from Hemophilia Joint Health Score 2.1 iv. EQ-5D-5L quality of life assessment~          score~        3. Data analysis: The p-value of less than 0.05 will be considered statistically~          significant. Mann-Whitney test will be used to test correlation of these variables (CBC,~          Factor VIII level, Factor VIII inhibitor level, Number of breakthrough bleedings, number~          of hospital stay, day-off from school, Hemophilia Joint Health Score 2.1, EQ-5D-5L~          quality of life assessment score) Sample size: 16 patients~      Potential impacts:~      The outcomes of different factor VIII concentrate dose between 15-20 U/kg/dose 2 times/week~     and 35-40 U/kg/dose 1 time/week will be revealed. These outcomes include number of~     breakthrough bleeding, number of hospital stay, day-off from school, joint health and quality~     of life. The result of this study will guide further study on optimal dose and duration of~     factor VIII treatment of hemophilia A patients in the future.~   "
64124|NCT02727634|"~     The heart is essentially a hydraulic pump which ensures adequate delivery of blood through~     generating pressure and forward flow of blood. The energy delivered by the heart is~     uncommonly measured clinically, and todays gold standard involves placing a plastic catheter~     into the lung arteries. The investigators have developed an ultrasound based approach to~     calculate this energy without the need for catheters through the heart. This novel approach~     is called ultrapower. Ultrapower involves the instantaneous multiplication of the cardiac~     output and the arterial blood pressure. The study aims to use the ultrasound based approach~     to investigate Cardiac Power in the coronary artery bypass graft population.~   "
64125|NCT02727621|"~     Dexmedetomidine is a unique sedative anesthetic agent that allows accurate control of the~     depth of sedation and provides analgesia, cardio protection, renal protection, and~     neuroprotection without causing respiratory depression. It is an alpha 2-adrenoreceptor~     agonist that modulates the release of catecholamines from the central and autonomic nervous~     systems. When patients sedated by dexmedetomidine are allowed to become responsive, they are~     calm and cooperative (1). No other sedative agent has this feature, and sedated patients~     frequently awaken in a confused state. Investigators are conducting this study project to~     compare between dexmedetomidine based and propofol based anesthetic techniques with regard to~     hemodynamic changes, stress hormone release as well as cytokines in patients undergoing CPB~     for coronary revascularization.~   "
64126|NCT02727608|"~     This is a dual centre, single arm, exploratory study of the possibility to use eculizumab~     (Soliris) to prevent/reduce destruction of islets of Langerhans after portal infusion of the~     islets in patients with diabetics accepted for islet transplant.~   "
64127|NCT02727595|"~     The purpose of the study is to evaluate safety, tolerability and performance of the CyclaPlex~     implant, a button and suture type implant device and instruments for the correction of the~     first inter metatarsal angle in subjects suffering from Hallux Valgus deformity.~   "
64128|NCT02727582|"~     Multidrug-resistant (MDR) tuberculosis (TB), defined as simultaneous resistance to isoniazid~     and rifampin, has been declared a global emergency. Treatment outcomes are poor, driven by~     toxicity and limited efficacy of the 2nd-line anti-TB drugs.~      Although there is evidence that both anti-TB activity and most of the toxicity of the key~     drugs are related to drug exposure, the pharmacokinetic/pharmacodynamic (PK/PD) relationships~     in patients with MDR-TB are poorly characterized. Moreover potential synergy of drug~     combinations has not been identified in the context of MDR-TB, dosing has not taken into~     account the concentrations needed to suppress resistance, and the role of minimum inhibitory~     concentrations (MICs) in dosing is poorly studied.~      There are therefore opportunities to optimize drug doses and combinations to improve~     efficacy, and reduce toxicity. Based on this observational study of patients on standard~     treatment for MDR-TB, our proposal builds on novel methodologies we have developed, largely~     for drug sensitive TB:~        1. The application of computational analytical techniques to tease out the individual~          contributions of anti-TB drugs used in combination~        2. The development of a treatment response biomarker model based on time-to-positivity in~          liquid culture of serial sputum samples.~        3. The in vitro determination of PK targets for anti-TB activity and the suppression of~          resistance using the hollow fiber models of Mycobacterium tuberculosis (Mtb) (HFM-TB).~      Thus the research will enhance our understanding of current modalities of TB treatment, while~     contributing research approaches for future regimen optimization.~      This protocol describes the clinical research component (points 1&2).~      Aim 1: To characterize the effects of 2nd-line drug exposures on treatment response in MDR-TB~     patients. The 2nd-line drugs to be examined are those comprising the standardized regimen~     used in South Africa: kanamycin, pyrazinamide, moxifloxacin, ethionamide and terizidone.~      Hypothesis: Amongst patients on standard MDR-TB treatment, variation in drug exposure has a~     quantifiable impact on the rates at which viable Mtb are cleared from the sputum.~      Aim 2: To identify drug exposures associated with the risk of treatment-related toxicities in~     patients on a standard 2nd-line regimen for MDR-TB.~      Hypothesis: The risks of specific toxicities associated with kanamycin, pyrazinamide,~     moxifloxacin, ethionamide and terizidone are linked to drug concentrations.~   "
64129|NCT02727569|"~     This study aims to compare two types of visual field test; retinal sensitivity values~     obtained with the reference standard Swedish Interactive Thresholding Algorithm (SITA) of the~     standard visual field test and with a newly developed test algorithm. The new test is a~     visual field test presented on a flat-panel monitor and has two modes: differential light~     sensitivity (DLS; equivalent to the standard visual field test) and the Moorfields Motion~     Displacement Test (MMDT). DLS sensitivity and DLS measurement variability will be determined~     and compared between the SITA algorithm of the standard visual field test and the new visual~     field test on the flat-panel monitor. The measurement variability of the MMDT will be~     quantified.~      The long-term goal is to reduce test variability below that observed in SITA by 20%, whilst~     producing comparable measurements (contrast threshold values) for comparable test duration.~   "
64130|NCT02727556|"~     In functional dyspepsia (FD), abnormal cognitive and emotional changes such increased~     sensitization, anxiety, and depression scores have been reported in addition to the~     peripheral changes in gastrointestinal tract functions. In this study, investigators will~     evaluate the activity of autonomic nervous system, emotional response, and visual attention~     to food and non-food images in 30 male and female FD patients and 30 age/gender-matched~     healthy volunteers. These data will provide a new finding of the influence of impaired~     cognitive processing of food on symptom generation in functional gastrointestinal disorder~     patients.~   "
64131|NCT02727543|"~     The purpose of this study is to evaluate the impact of the Medisafe smartphone application on~     blood pressure control and self-reported medication adherence for patients with uncontrolled~     blood pressure.~   "
64132|NCT02727530|"~     The main goal of this study is to get to know if applying manual therapy will reduce the~     infant colic symptoms for to improve quality of life of babies and parents.~   "
64133|NCT02727517|"~     This study evaluates the hypothesis that delayed compared to early umbilical cord clamping~     will improve neonatal transition in terms of circulation and breathing during resuscitation.~   "
64136|NCT02727478|"~     This effectiveness-implementation study is a part of the larger study BETA-PD (Balance,~     Elderly, Training and Activity in Parkinson's Disease), which has the long-term goal to~     reduce the risk of falling in people with Parkinson's disease (PD) by improving balance, gait~     and physical activity level. The main hypothesis is that highly challenging balance training~     will lead to greater gait and balance ability, increased levels of physical activity and an~     improved health related quality of life. The main aims of the study are to evaluate the~     effectiveness of the HiBalance program in real-life clinical settings, while exploring~     facilitators and barriers for program implementation on a wider scale.~   "
64137|NCT02727465|"~     At any time, around 10% of people carry meningococcal bacteria in the nose and throat, which~     can cause meningitis, blood poisoning and other serious illnesses. Most people carry these~     bacteria and never become ill, yet a very small proportion go on to develop these illnesses~     which can result in life long disabilities or death. The mechanism by which this happens is~     poorly understood and has been studied in various ways, usually focussing on the bacteria or~     on the individual, but none has given a definitive answer. This study will be the first of~     its kind and will assess the interaction between the host and the bacteria at the genetic~     level, through genetic mapping, helping us to understand what makes some people susceptible~     to this infection.~   "
64138|NCT02727452|"~     The randomised study analyzes the effects of immediate bonding (skin-to-skin contact) on~     different psychobiological and somatic outcomes of mother and child. The investigators~     compare 3 bonding conditions. Cortisol and Oxytocin are also measured during the bonding~     process.~   "
64139|NCT02727439|"~     It is well recognized that chronic exercise protects against the development of~     cardiovascular diseases. However, the responses of vasculature to acute exercise (AE) are not~     well known and not consistent in literature. Acute exertional exercise can induce large,~     transient increases in arterial pressure and development of metabolic acidosis which can be~     associated with pro-inflammatory response involving oxidant stress and circulating cytokines~     known to impair endothelial function.~      The aim of this study is to test the impact of a single exposure to exhausting training on~     microvascular reactivity in healthy sedentary subjects and athletes.~   "
64140|NCT02727426|"~     It is well accepted that high-salt (HS) intake is an essential risk factor in development and~     progression of hypertension. Results of some recent studies suggest that some of the~     deleterious effects of a HS diet are independent of elevated blood pressure (BP) and may~     occur in normotensive individuals and are associated with impaired endothelial function.~     However, the effects of acute salt loading on endothelial function and vascular reactivity in~     young healthy individuals are still scarce and inconsistent.~      The purpose of present study is to determine whether one week of HS intake affects~     microvascular reactivity in young healthy subjects without changes in BP. In addition, the~     investigators sought to evaluate if potential HS diet-induced microvascular dysfunction is~     associated with changes in oxidative stress level and/or with modification of immunological~     response in young healthy subjects.~   "
64141|NCT02727413|"~     The study aims at the comparative examination of pre-, intra- and post-operative release~     profiles of inflammatory and vasoactive mediators in patients undergoing heart valve surgery~     under cardiopulmonary bypass (CPB) due to either infectious endocarditis or degenerative~     valvular heart disease. Specific attention will focus on the distinction between mediator~     release associated with infection and that resulting from CPB. Concomitantly identification~     and characterization of infectious pathogens in the circulation and in valvular samples will~     be carried out, together with the search for resistance-coding transcripts.~   "
64142|NCT02727400|"~     Oocyte maturation requires a lot of energy, which is provided by the mitochondria via the~     synthesis of ATP. The majority of patients with advanced maternal age (AMA) have poor egg~     quality. One of the reasons depends on oxidative phosphorylation of Pyruvate to undergo~     maturation; on the contrary, the cells of the cumulus (CC) show great activity glycolytic so~     that these cells are able to provide ATP(adenosine triphosphate and energy substrates to the~     oocyte. The goal of this work is to analyze the mitochondrial function and energy production~     in oocyte donors compared with a group of women of advanced maternal age subject to a same~     ovarian stimulation Protocol~   "
64143|NCT02727387|"~     Study for the treatment of metastatic Ewing sarcoma with high doses chemotherapy,~     radiotherapy and maintenance therapy.~   "
64144|NCT02727374|"~     Fear to fall has been proven to be a risk factor affecting those geriatric patients who have~     previously suffered a fall. In this work it is assessed the effectiveness of a physiotherapy~     and psychological combined intervention, aimed at reducing the fear to fall in the~     aforementioned patients~   "
64145|NCT02727361|"~     Dystonia is defined as a syndrome of sustained muscle contractions resulting in repetitive~     movements and abnormal postures. DYT1 is the most common form of genetic dystonia, but the~     link between genomic mutations and phenotypic expression remains largely unknown.~     Furthermore, secondary forms of dystonia have highlighted the role of the basal ganglia,~     particularly the putamen in the pathophysiology of the disease. Experimental results in a~     genetic model of dystonia in rodents suggest that cholinergic inter-neurons (ACh-I) of the~     putamen play a critical role in the pathological process of plasticity in the~     cortico-striatal synapse. However, these results have not been demonstrated in humans.~   "
64146|NCT02727348|"~     Background:~      Dysautonomia refers to the abnormal function of the autonomic nervous system including~     sympathetic and parasympathetic nervous system. Diabetes mellitus causes secondary~     dysautonomias (1). The Survey of Autonomic Symptoms (SAS) is a simple and validated tool to~     assess the presence and severity of autonomic symptoms (2).~      Diabetic patients also suffer from chronic neuropathic pain. After amputation surgeries, up~     to 78% of these patients may develop post surgical neuropathic pain (3). The self-report~     version of the Leeds Assessment of Neuropathic Symptoms and Signs pain scale (S-LANSS) is~     validated as a diagnostic tool to assess patients with neuropathic pain (4). This scale will~     be used to assess if there is any changes in the pain experienced after diabetic foot~     surgery.~      Currently, both spinal anaesthesia (SAB) and ultrasound guided femoral and sciatic peripheral~     nerve blocks (FSNB) are acceptable anaesthesia for dysautonomic diabetic patients with~     diabetic foot ulcer going for wound debridement, Ray's amputation and below knee amputation~     (5)~      Many studies have compared multiple perioperative parameters of patients undergoing lower~     limb surgery under peripheral nerve blocks versus spinal anaesthesia. These parameters~     include preparation time, anaesthetic complications (e.g. hypotension, nausea and vomiting,~     post-dural puncture headache, urinary retention), patient satisfaction and postoperative pain~     control (6,7,8).~      The investigators want to study if patients with dysautonomia have a different haemodynamic~     response to spinal anaesthesia or peripheral nerve blockade changes compared to patients with~     normal autonomic function.~      Secondarily, the investigators would also study if there is a difference in post operative~     pain control as well as incidence in chronic pain in patients who receive spinal anaesthesia~     versus peripheral nerve blockade.~   "
64147|NCT02727335|"~     Description of clinical and anatomical features and long-term follow-up for patients with ALK~     rearrangement and treated by crizotinib~   "
64148|NCT02727322|"~     The specific aim of this randomized double-blind placebo-controlled trial is to determine if~     extended release nitrofurantoin antibiotic prophylaxis decreases the incidence of symptomatic~     urinary tract infection (UTI) compared with placebo for patients undergoing short term~     indwelling or clean intermittent self-catheterization (CISC) for acute postoperative urinary~     retention following pelvic organ prolapse and/or urinary incontinence surgery.~      Consented patients who undergo urogenital surgery and fail their post-operative voiding trial~     will be randomized to either extended release nitrofurantoin 100mg or an identical appearing~     placebo capsule to be taken daily while performing CISC or while indwelling catheter is in~     place. The primary outcome will be symptomatic and culture confirmed UTI within six weeks of~     surgery. Secondary outcomes include adverse events associated with nitrofurantoin use, and~     incidence of nitrofurantoin-resistant isolates from urine culture of symptomatic women.~      Primary and secondary outcomes will be evaluated with Student t test and chi squared or~     Fisher exact test as appropriate. Assuming a decrease in symptomatic UTIs attributable to~     nitrofurantoin prophylaxis from 33% to 13%, with 80% power, and a two-sided alpha of 0.05,~     and a 10% dropout rate, we should recruit a total of 154 patients.~   "
64149|NCT02727309|"~     This study is designed to evaluate the efficacy and safety of TACE combined with apatinib in~     treating advanced hepatocellular carcinoma. The primary endpoint is progression-free survival~     (PFS), 3-month PFS, 6-month PFS and 1-year PFS.~   "
64150|NCT02727296|"~     To compare the effect of a sevoflurane based anesthesia versus a propofol based anesthesia on~     the incidence of DGF in recipients of kidneys of donation after circulatory death (DCD) and~     donation after brain death (DBD) donors~   "
64151|NCT02727283|"~     GSK3179106 is a potent and relatively selective inhibitor of RET kinase which has been~     designed to be a safe and effective therapy for irritable bowel syndrome (IBS) patients .~      This is a randomized, double-blind (sponsor unblind), placebo-controlled, dose escalating,~     four period, single-dose crossover, first time in human study to assess the safety,~     tolerability and pharmacokinetics of GSK3179106 in normal healthy subjects.~      The study will be composed of 2 cohorts, each having screening (21 days prior to first dose~     of study drug), Treatment, and follow-up periods (7-10 days after their last dose [Day 1 of~     dosing period 4]). The Treatment period will include 4 dosing periods. Subjects will~     participate in either Cohort 1 or Cohort 2. The total duration of the study for each subject~     will be approximately 10 weeks. A sufficient number of healthy subjects will be screened to~     enrol 16 subjects who complete the planned study procedures. Each dosing period will be~     staggered so that only 2 of the 8 subjects will be administered study drug initially. Once 24~     hours (h) have elapsed, and provided there are no safety concerns, the remainder of subjects~     scheduled for that dosing period may be dosed. A review of safety and tolerability will occur~     prior to administration of the next dose level. This same procedure will be followed for each~     escalating dosing period. Subjects assigned to Cohort 1 will participate in 1 placebo and 3~     dose escalating periods. Subjects assigned to Cohort 2 will participate in up to 4 dosing~     periods which include up to 2 escalating doses and placebo in Periods 1 and 2, and a pilot~     food effect in Periods 3 and 4. Within each cohort, subjects will return for their next~     scheduled dosing period approximately 14 days after administration of the study drug during~     the prior dosing period. Cohort 2 will proceed after completion of the treatment periods in~     Cohort 1. Each subject will be enrolled in only one cohort. The planned dose range is 10~     milligram (mg) to 200 mg in Cohort 1. The actual doses to be administered may be adjusted~     based on safety, tolerability, and pharmacokinetic data at previous dose levels; these dose~     adjustments may involve either an increase or a decrease in the planned dose for both Cohorts~     1 and 2. There are no formal hypotheses being tested in this study.~   "
64152|NCT02727270|"~     The objective of this study is to evaluate the cortisol awakening response with persons with~     PD and moderate levels of stress as compared to controls and persons with PD and low levels~     of stress. These data are desired so experience can be gained with measuring stress levels~     subjectively and objectively in persons with PD.~   "
64153|NCT02727257|"~     In this study the Investigators explore two questions: if the attentive reaction times~     differs in parkinsonian patients from health controls and if an intensive, focused and~     aerobic rehabilitation program (Multidisciplinary Intensive Rehabilitation Treatment - MIRT)~     tailored mainly for motor problems, could have a specific positive effect on multiple choices~     Reaction Times (RTs) as an indirect marker for an effect on attentional-executive frontal~     circuits. The hypothesis is that the MIRT could have a positive effect on the top-down~     control mechanisms, since the continuous feedback given by physiotherapist during exercises~     and the use of cues and devices (such as treadmill plus and stabilometric platform),~     stimulate the selective attention processes that enable goal-directed, internally-driven~     decision, helping the patients to overcome externally-driven decision based on stimulus~     salience and novelty~   "
64154|NCT02727244|"~     This study is aimed to elucidate the association between Pain Catastrophizing Scale Score and~     Postspinal Headache in Patients Underwent Cesarean Section With Spinal Anesthesia.~   "
64155|NCT02727231|"~     The main objective of this study is to determine whether day and night closed-loop insulin~     delivery for 4 weeks under free living conditions is superior to usual insulin pump therapy~     in adults with type 1 diabetes and HbA1C<7.5%.~      This is an open-label, multi center, randomized, crossover design study, involving a 2-4 week~     run-in period, followed by two 4 weeks study periods during which glucose levels will be~     controlled either by an automated day- and night closed-loop system or by subjects usual~     insulin pump therapy in random order. A total of up to 34 adults (aiming for 24 completed~     subjects) aged 18 years and older with T1D on insulin pump therapy and HbA1C<7.5% will be~     recruited through diabetes clinics and other established methods in participating centers.~      Subjects will receive appropriate training in the safe use of closed-loop insulin delivery~     system. Subjects will have regular contact with the study team during the home study phase~     including 24/7 telephone support.~      The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L as recorded by~     CGM during home stay. Secondary outcomes are time spent with glucose levels above and below~     target, as recorded by CGM, and other CGM-based metrics.~   "
64156|NCT02727218|"~     prospective study, involves 60 patients underwent thoracoscopic surgery, the patients will be~     divided into two groups, the first group will undergo early chest tube removal - after three~     hours, the second group will have late chest tube removal according to the department's~     protocol.~      the study aims to prove the possibility and non inferiority for early chest tube removal for~     thoracoscopic surgeries with non complicated surgical course.~   "
64157|NCT02727205|"~     STUDY TITLE:~      A Multiple Site Study to Evaluate the Irritation and Sensitization Potential of Repeat~     Applications of Rotigotine Transdermal System, 1 mg/24 hr Versus Neupro (Rotigotine~     Transdermal System), 1 mg/24 hr in Healthy Volunteers~      TEST DRUG / INVESTIGATIONAL PRODUCT:~      Rotigotine Transdermal System, 1 mg/24 hr~      INDICATION STUDIED:~      Bioequivalence - Irritation and Sensitization~      STUDY DESIGN:~        -  Multiple-site, randomized, multiple-application, evaluator-blinded, controlled study~        -  One-half (½) of the test patch and one-half (½) of the reference patch was applied daily~          to the same site for each product over a 21 day period followed by a rest phase and a~          challenge phase~   "
64158|NCT02727192|"~     Atrial fibrillation (AF) is the most common cardiac rhythm disturbance in adults, with~     prevalence expected to rise significantly the coming decades. The occurrence of AF is~     associated with significantly increased mortality as well as morbidity of which~     cerebrovascular accidents is the most important. Unfortunately treatment options remain~     limited. Anti-arrhythmic drugs are widely used but have limited efficacy and the potential~     for toxicity and adverse events are recognized. Recent year's catheter ablation of AF~     continues to gain acceptance for symptomatic treatment, but recurrence rate are high with~     need for continuous medication. Thus there is a need to better understand what causes~     development and triggers episodes of AF as well to introduce new treatment options.~     Cardiometabolic factors such as obesity, inactivity and sleep apnea (SA) have therefore~     gained interest. Many patients with AF have chronic sleep apnea, and in the present study we~     want to explore the interaction between SA and AF. The hypothesis of the present study is~     that SA may trigger AF and that treatment of SA will reduce the overall burden of AF as well~     as reduce the recurrence of AF after pulmonary vein ablation. To test the hypothesis we will~     implant a Reveal device that continuously records the hearts rhythm of 100 patients with~     paroxysmal AF and concomitant SA. Initially the influence of SA on onset of AF will be~     examined, and the patients will then be randomized to treatment of SA or not and the~     influence on total AF burden recorded both before and after ablation.~   "
64159|NCT02727179|"~     This study evaluates the feasibility of laparoscopic surgery in patients diagnosed with~     colorectal liver metastases. Half of participants will be operated on by laparoscopic~     approach and the results obtained will be compared with the results from the other half of~     patients operated on by open approach.~   "
64160|NCT02727166|"~     Subjects with gas-related complaints exhibit impaired handling of intestinal gas loads and we~     hypothesized that inulin would have a beneficial effect. Aim: to determine the effect of a~     prebiotic chicory-derived inulin-type fructan on the tolerance of intestinal gas. Methods.~     Placebo-controlled, parallel, randomized and double-blind trial study. Subjects with~     abdominal symptoms and reduced tolerance of intestinal gas (selected by a pre-test) will~     receive either inulin (8 g/d, n=18) or maltodextrin as a placebo (8 g/d, n=18) for 4 wk. A~     gas challenge test (4 h jejunal gas infusion at 12 mL/min while measuring abdominal symptoms~     and gas retention for 3 h) will be performed before and at the end of the intervention phase.~     Gastrointestinal symptoms and bowel habits (using daily questionnaires for 1 wk) and fecal~     bifidobacteria counts will be measured before and at the end of the intervention.~   "
64161|NCT02727153|"~     Background. Enhanced Recovery After Surgery (E.R.A.S.) programs are now widely accepted in~     colonic laparoscopic resections because of faster recovery and less perioperative~     complications.~      Objective. Aim of this study is to assess safety and feasibility of discharging patients~     operated on by laparoscopic colectomy on Post Operative Day 2 (POD 2), so long as the first~     flatus has passed and in the absence of complication-related symptoms.~      Design & Settings. Non-inferiority, open-label, single center, prospective, randomized study~     comparing Ultra to Classic E.R.A.S. with discharge on POD 2 and 4 respectively.~      Patients. 765 patients with resectable non metastatic colonic cancer were analyzed: 384~     patients were assigned to Ultra E.R.A.S. and 381 to Classic E.R.A.S.~      Main Outcome Measures. Demographics, clinico-pathological, ASA class and morbi-mortality,~     along with surgical complications, re-operation and readmission rate were recorded and~     compared. Primary end-point was mortality; secondary end-points were morbidity, re-admission~     and re-operation rate.~      Limitations. It is a single center experience; it is not double-blind, with the intrinsic~     risk of intentional or unconscious bias; exclusion criteria because of non compliance may~     be considered arbitrary.~   "
64162|NCT02727140|"~     The proposed study aims to investigate the feasibility, effectiveness, and perceived benefit~     of a supportive hatha yoga intervention for patients with hypertension using antihypertensive~     drugs. Patients will be randomized into 3 groups comparing hatha yoga with yoga postures,~     breathing and relaxation techniques to a hatha yoga intervention without yoga postures (only~     breathing and relaxation techniques) as well as to a wait list control group.~   "
64163|NCT02727127|"~     In this project, investigators intend to carry out the first simultaneous, in vivo, imaging~     study of lithium content and sodium ion homeostasis in the brain of Bipolar Disorder (BPD)~     patients under Lithium therapy.~   "
64164|NCT02727114|"~     To optimize a medical device for intradermal injection, knowledge concerning the thickness of~     epidermis and dermis at the proximal forearm is required. Since scientific knowledge is~     lacking, the investigators will examine the skin thickness (epidermis and dermis) of children~     (aged 8 weeks to 18 years) using imaging technology (High Frequency Ultrasound). The~     investigators hypothesize that they are able to correlate the thickness of the (epi)dermis to~     a specific combination of parameters age, gender, and BMI.~      Based on these results, the investigators can define which needle type and length is needed~     to correctly perform injections into the dermal layer~   "
64165|NCT02727101|"~     The goal of the present study is to evaluate (screen) a large number (12) of different dual~     therapies of perampanel + another AED (PMP+) for a large, 75-100% seizure frequency~     reduction. The design of the study will differ from usual AED studies. The study will be (i)~     open label, with (ii) a small n per group, n=6, with (iii) outcome measures a 'blockbuster~     effect': (a) ≥75 seizure frequency reduction; and (b) seizure freedom.~   "
64166|NCT02727088|"~     Epidemiological data show a significant rate of failure of endodontic treatment of 20 to 50%~     worldwide, probably directly related to the difficulty of the procedure. A successful~     pulpotomy allows the preservation of a vital radicular pulp into the root canal. The presence~     of a biological tissue into the root canal is definitely more efficient than a complete~     filling with an inert material. It has been shown on animal and human studies that this pulp~     stump in contact with the biomaterial is able to regenerate a dentinal plug, with the same~     architecture as physiologic dentin.~      Primary objective : To compare the success rates of root canal treatment (reference) and~     conservative treatment (pulpotomy) for treating inflamed dental pulp on permanent mature~     teeth.~      Secondary objectives : (1) To describe the clinical and biological prognostic factors of~     these two treatments; (2) to assess the additional value of biomarkers expression levels as a~     prognostic tool for clinical decision making (radical vs. conservative treatment); (3) to~     assess the impact of treatment on post-procedural pain.~      This trial aims to demonstrate the non-inferiority of conservative pulpal treatment over~     endodontic treatment.~      Patients consulting in one of the seven study centers, presenting one of the indications~     retained for the trial and giving written informed consent will receive the treatment~     (endodontic treatment or conservative treatment) allocated by randomization (stratified over~     the clinical diagnosis of the pulp status).~      The follow up of patients include, a phone call at D15, and visit at 1, 6, 12 and 14 post~     operative months. Clinical examination and Xrays at 6, 12 and 24 months) will be used to~     evaluate the success or failure of the treatment.~      During the treatment, a sample of pulp tissue will be withdrawn and transferred to a~     molecular biology laboratory for analysis of inflammation biomarkers. The aim of this part of~     the sudy is to assess a putative relationship (1) of regulation of biomarkers expression and~     clinical diagnosis, and (2) of regulation of these biomarkers and success rate of pulpotomy.~      Success/failure evaluation:~      The primary endpoint is the time to necessity of endodontic reintervention (analysed as a~     time to failure). This study will use an Intention To Treat analysis as its main assessment ;~     a secondary assessment accounting for peroperative conversions will assess the practical~     impact of these conversions. We will distinguish~        -  Direct failure (means that the failure is directly correlated to the treatment) : the~          reintervention need is due to the evolution of the treated tooth. This includes delayed~          onset of desmodontitis, periodontal space enlargement and/or periapical/periradicular~          radiolucency (PAI>2) demonstrating an infection of the root canal system (filled by~          either pulpal stump or filling material).~        -  Indirect failure (means that the cause of the failure is not directly related to the~          endodontic treatment choice) : any event leading to endodontic reintervention indication~          NOT caused by radicular infection or restoration failure attributable to inadequate~          restoration. For example : new need of post-placement for treatment of loss of another~          tooth, unexpected progression of periodontal disease.~      Both these failure modes are of interest for analysis : the direct failure time is an~     indication if the intrinsic value of a therapy, whereas the gross (direct+indirect) failure~     time is an indication of its clinical relevance (a good therapy applicable in rare cases may~     be less interesting than a mediocre but widely applicable one).~      Statistical analysis:~      The classical methods of descriptive analysis will be used to describe the raw results.~      In order to make inferences directly on possible clinical results, this study will be~     analyzed in a Bayesian framework.~      This study has been designed in reference with a frequentist demonstration of~     non-inferiority.~      A non-inferiority trial with first and second species error rates α and β has the same~     operational characteristics as a superiority (unilateral trial) of error rates alpha and~     beta, which in turn needs the same study size as a comparison (=bilateral) trial with error~     rates α and 2β.~      The final planned size of the trial is established as follows :~        -  Ideal plan : a nonparametric comparison (logrank test) fulfilling these goals according~          to this plan needs 158 patients overall under perfect information assumptions (no loss~          to follow-up, single analysis)~        -  Loss to follow-up : the expected loss to follow-up will cause about 22% of included~          patients to drop out of the study before final analysis this leads to include 194~          patients overall.~      Sequential analysis : since we wish to be able to follow the progress of the study, and to~     interrupt it if the main goal is reached, we choose to use a sequential analysis. A Pocock~     scheme needs to increase the sample size by 16% , leading to plan to recruit 226 patients~     overall.~   "
64167|NCT02727075|"~     This study aims to characterize the diagnostic performance of immunological testing of occult~     gastrointestinal bleeding in stool in the population aged over 75 years with iron deficiency~     anemia.~      As secondary objectives, the study aims to:~        -  determine a threshold of positivity optimizing the immunoassay performance for the study~          population, in accordance with the probabilities of error (false positives, false~          negatives) and weights (defined by expert consensus) allocated to these errors.~        -  Assess the benefit of a double measure of bleeding (two stools) by immunoassay compared~          to a single measure.~   "
64168|NCT02727062|"~     This research is being done to evaluate whether or not the Oral Mucositis (OM) Pain App (a~     smartphone application) is a feasible and valid tool to assess pain from radiation sores~     (also referred to as mucositis) when treating head and neck cancers with radiation. The~     mobile app will be designed to help people better understand the pain from the radiation~     sores.~   "
64169|NCT02727049|"~     The purpose of this research is to:~        1. determine the normal or existing dynamic biomechanics of college athletes and~        2. test the effectiveness of osteopathic manipulative medicine in the treatment of athletic~          injuries.~      Motion capture using Vicon systems allows researchers to quantify characteristics of a body~     such as the range of motion of the hip or shoulder during an athletic technique such as~     kicking or shooting a basketball into the basket. The quantified information has been used~     before to better understand human mobility and performance. Osteopathic manipulative medicine~     (OMM) is manual medicine applied to joints, muscles, and connective tissue with a goal of~     improved body functions. Research demonstrating effectiveness of OMM on the musculoskeletal~     and associated connective tissue systems health includes, among others, prospective clinical~     trials of OMM for treatment of neck pain, low back pain, and acute first- and second-degree~     ankle sprains.~   "
64170|NCT02727036|"~     The purpose of this randomized control trial is to compare the effect of pumpkin seed oil~     2g/day with pumpkin seeds given as a dose of 1½ teaspoons/ 4.1 grams a day to provide 2g of~     lipid (equivalent to 2 grams of oil) on BP (systolic and diastolic), endothelial function,~     serum lipids, C-reactive protein (CRP) concentrations, and menopausal symptoms in~     postmenopausal women.~   "
64171|NCT02727023|"~     The Investigators will be studying the effects of Osteopathic Manipulative Lymphatic Pump~     Treatment on levels of anandamide in Saliva. A qualitative scale will also be used to measure~     the canabinomimetic effects of osteopathic treatment.~   "
64172|NCT02727010|"~     Background Women with rare diseases resulting in motor disabilities wishing to become mother~     face a major challenge. The investigators hypothesize that provided with adequate support,~     they are able to achieve a successful pregnancy and to offer their child a safe family~     environment.~      Methods To test this hypothesis, the investigators shall conduct a prospective observational~     prospective survey of a consecutive series of volunteer pregnant women or mothers of children~     less than 14 months, with motor impairment, participating in a program of parenting support~     developed in our institution.~      Primary outcome: social environment, child development, mother-infant attachment, mother-~     infant interactions Secondary outcome: social and demographic characteristics, severity of~     motor impairment, associated impairment, perinatal morbidity for the mother and the infant~     (composite indicator), emotional status, and the needs expressed by women regarding the level~     of medical or social care.~      Analysis The investigators shall describe the distribution of the primary outcome~     measurements in the subgroup of women with motor impairment related to a rare disease. The~     investigators shall compare this distribution to the expected distribution in the general~     population, and to that observed in women with motor impairment unrelated to a rare disease.~     The investigators shall also study primary outcome measurements as a function of the severity~     of maternal disability, of the mother's social characteristics and emotional status.~      The investigators shall also describe the distribution the distribution of perinatal~     morbidity globally, and as a function of the potential explanatory variables mentioned above.~      The investigators shall also report on the opinion of women regarding the support they were~     offered so far, and the support they declare they should benefit from.~   "
64173|NCT02726997|"~     The goal of this clinical research study is to learn about the safety of giving the~     combination of MEDI4736 (durvalumab), carboplatin, and paclitaxel to patients with high-grade~     epithelial non-mucinous ovarian, primary peritoneal, or fallopian tube cancer. Researchers~     also want to learn how the study drug combination may affect DNA and RNA (the genetic~     material in cells) and proteins.~      This is an investigational study. Durvalumab is not FDA approved or commercially available.~     It is currently being used for research purposes only. Paclitaxel and carboplatin are FDA~     approved and commercially available. The study doctor can explain how the study drugs are~     designed to work.~      Up to 30 participants will be enrolled in this study. All will take part at MD Anderson.~   "
64174|NCT02726984|"~     Carotid plaque can lead to ischemic stroke. Treatment of asymptomatic carotid plaque, based~     on degree stenosis, is still controversial. Beyond the degree of stenosis, the composition of~     the plaque could reflect the vulnerability and the risk of ipsilateral ischemic stroke.~     Identification of new predictive factor of ipsilateral ischemic stroke in patients with~     carotid plaque could help to screen high risk patients and to guide the treatment. The aim of~     the study is to assess 18F-sodium fluoride uptake among carotid plaque in recently~     symptomatic and asymptomatic patients. Investigators conduct a pilot case-control study.~     Twelve patients (6 recently symptomatic and 6 asymptomatic) with carotid stenosis (≥50%~     NASCET) will have a 18F-sodium fluoride PET/MR. Standardized uptake value (SUV) and~     tissue-to-background ratio (TBR) will be measured among carotid plaques.~   "
64175|NCT02726971|"~     This single-center,prospective,randomized,controlled trial is conducted to evaluate the~     efficacy of different doses of estrogen artificial periodic therapy after hysteroscopic~     adhesiolysis in patients with moderate-severe adhesion.~   "
64176|NCT02726958|"~     Stress hyperglycaemia is a well-known risk factor of postoperative morbidity and mortality in~     cardiac surgery. Recently, several authors have reported that increased blood glucose (BG)~     variability could worsen the prognosis in this population.The transcatheter aortic valve~     implantation (TAVI) is a low invasive procedure proposed as an alternative technique to~     aortic valve replacement surgery in high-risk patients.~      The aim of this study is to describe the incidence of stress hyperglycaemia and assess~     whether BG variability could impact the outcome of patients undergoing TAVI.~   "
64177|NCT02726945|"~     This is a pivotal study. The study will examine the safety and efficacy of autologous~     adipose-derived stromal vascular fraction (SVF) cells processed with the GID SVF-2 device for~     pain, function and stiffness in the knees of osteoarthritic subjects.~   "
64178|NCT02726932|"~     The purpose of this study is to analyze the correlation between intra-abdominal view and~     patient recovery in secondary peritonitis, and to create a new classification based on these~     results. Additionally, a variety of inflammatory markers from blood samples will be collected~     in order to analyze their correlation with patient outcomes.~   "
64179|NCT02726919|"~     The goal of the present study is to obtain pilot data on efficacy and safety of clobazam~     add-on treatment on adults with drug-resistant focal epilepsy.~      This will be an open label study comparing seizure frequency during 12 weeks of baseline~     observation period with seizure frequency during 16 weeks of clobazam adjunctive treatment.~     10 adults aged 18-65 with focal seizures that have failed to respond to ≥ 4 antiepileptic~     drugs (AEDs) +/- respective surgery will be enrolled. Following a baseline of 12 weeks~     patients will be started on clobazam, administered orally in b.i.d. schedule. In patients in~     whom seizure diaries have been kept prospectively prior to study screening visit,~     retrospective baseline will be accepted. Patients will be titrated up to either seizure~     freedom, to side effects or to 40 mg/day, whichever comes first. Titration rate will be not~     be forced. It is anticipated that the majority of subjects will have a 4 week-long titration~     period. After maximum dose is achieved, maintenance treatment will last for 12 weeks.~   "
76914|NCT02560246|"~     The purpose of this study is to determine whether diet and the gut microbiome play a role in~     spontaneous preterm birth (SPTB), namely delivery of the fetus prior to 37 weeks gestation.~   "
64182|NCT02726880|"~     The fifth revision of the Diagnostic and Statistical Manual for Mental Disorders includes in~     its research appendix a potential new diagnosis—Internet gaming disorder. This condition~     primarily affects adolescent boys and young adult men, who rarely seek treatment on their~     own. More often, parents express concerns about their child's game playing behaviors. This~     psychotherapy development study will evaluate feasibility and effect sizes of an intervention~     designed to help parents reduce their child's gaming problems; the intervention allows for~     child participation, but it is geared toward parents, regardless of whether or not their~     child is willing to participate. A total of 40 parents concerned about their child's gaming~     behaviors will complete self and parental report inventories and structured diagnostic~     interviews regarding gaming, substance use and psychosocial functioning. Children who elect~     to participate will complete parallel versions of the instruments. Participants will be~     randomized to a control condition consisting of referral for mental health issues and family~     support services or to a 6-week behavioral intervention designed to assist with better~     monitoring and regulating the child's game playing behaviors. Gaming and other problems will~     be assessed pre-treatment, at the end of treatment and at a 4-month follow-up. This study~     will be the first to evaluate the reliability and validity of a parental version of the fifth~     revision of the Diagnostic and Statistical Manual for Mental Disorders criteria for internet~     gaming disorder in a clinical sample, and it will assess associations of internet gaming~     disorder with substance use, mental health conditions, and family functioning as well. This~     study will be the first randomized trial of an intervention designed to assist parents in~     reducing their child's gaming problems, and results will help guide future development of~     interventions for Internet gaming disorder. To evaluate the feasibility and acceptability of~     this intervention, the proportion of parents assigned to the intervention who complete 6~     sessions will be examined, as will the proportion of youth who attend the sessions. Parent~     and child ratings of satisfaction with the intervention will be assessed. To examine the~     effect size of the intervention on reducing gaming, parental reports of proportion of days on~     which their child played games and durations of game playing will be compared between~     conditions, controlling for baseline indices.~   "
64183|NCT02726867|"~     The purpose of the study is to evaluate the efficacy and safety of levetiracetam , lacosamide~     and ketamine treatment of refractory status epilepticus. This will be a randomized,~     open-label, four-arm pilot study comparing time to cessation of refractory status~     epilepticus, determined by continuous EEG monitoring, in patients with refractory status~     epilepticus. Patients with status epilepticus who have been treated with standard dose~     lorazepam (or midazolam) and ≥ 1000 mg phenytoin with documented levels of ≥20 mg/ml and~     continue to have clinical status epilepticus for ≥1-24 hours after phenytoin loading will~     receive intravenously (i.v.) either 4000 mg levetiracetam, 600 mg lacosamide (Group B), 2.5~     mg/kg ketamine or phenobarbital 15 mg/kg phenobarbital (Group D)~   "
64184|NCT02726854|"~     The main research purpose Evaluation of objective response Apatinib second-line treatment of~     advanced pancreatic cancer (ORR) and the rate of progression free survival (PFS).~      Objective to study the objective and exploratory secondary research To observe the Apatinib~     in second line treatment of advanced pancreatic cancer disease control rate (DCR), patients~     with overall survival (OS) benefit, treatment effects on quality of life (QOL) score and drug~     safety evaluation, To investigate the relationship of apatinib as second-line treatment of~     advanced pancreatic cancer and the expression of vascular endothelial growth factor~     receptor(VEGFR) in the serum~   "
64185|NCT02726841|"~     Authors hypothesize that thoracoabdominal aortic repair combined with bare metal stent~     implantation is superior over standard thoracoabdominal aortic repair.~   "
64186|NCT02726828|"~     this study investigates the analgesic efficacy and other possible effects of ketamine,~     morphine, and both together when administered intrathecally for control of postoperative pain~     following lower abdominal cancer surgeries.~   "
64187|NCT02726815|"~     Primary Objective~      The aim of this research study is to develop a comprehensive inventory of symptoms that occur~     in children with advanced cancer who are receiving a specialist palliative care service.~      Secondary Objectives~        -  To assess correlation between parent, child and nurse scores on the Memorial Symptom~          Assessment Scale (MSAS).~        -  To identify symptom prevalence in children with advanced cancer as identified by the~          child/young person (CYP), nurse and parent (to be analysed separately for parent, child~          and nurse).~        -  To identify whether there are any symptoms missing from the age appropriate MSAS as~          identified by the CYP, nurse and parent (to be analysed separately for parent, child and~          nurse).~        -  To identify whether any items on the age appropriate MSAS are not relevant to the~          population being studied (to be analysed separately for parent, child and nurse).~        -  To identify which symptoms cause the most distress as identified by the CYP, nurse and~          parent (to be analysed separately for parent, child and nurse).~        -  To identify degree of severity of each symptom as identified by the CYP, nurse and~          parent (to be analysed separately for parent, child and nurse).~        -  To identify which symptoms occur most frequently as identified by the CYP, nurse and~          parent (to be analysed separately for parent, child and nurse).~        -  To assess the trends between phase of illness and symptom profile, severity and~          distress.~   "
64188|NCT02726802|"~     This study aims to compare the self-report functional outcome measures, medical readiness and~     healthcare utilization (overall cost of imaging, prescription medications for pain, and~     follow-up visits) of soldiers with musculoskeletal injuries first seen by a physical~     therapist versus primary care provider.~   "
64189|NCT02726789|"~     The REP 201 protocol is a small exploratory study assessing the antiviral effects and~     tolerability of REP 2139-Ca when used with a full course of pegylated interferon (48 weeks)~     in treatment naive patients or in patients already receiving entecavir and continuing~     entecavir with treatment.~   "
64190|NCT02726776|"~     Suspension syndrome refers to a potentially life-threatening condition that can occur in~     unconscious persons after prolonged suspension in a harness. To date, our understanding of~     the pathophysiology and appropriate treatment is based primarily on case reports and expert~     opinion. The main pathophysiological hypothesis implicates blood pooling in the lower~     extremity and lack of return via muscle pumping. However, a recent French study could not~     support this hypothesis. Other mechanisms, such as a central vagal reflex may play a role in~     the pathophysiology of suspension syndrome. The aim of this study is to better understand the~     pathophysiological basis of suspension syndrome and to develop practical recommendations for~     prevention and treatment.~   "
64191|NCT02726763|"~     In this study, the investigators are testing transcranial direct current stimulation (tDCS)~     in breast cancer survivors. In this pilot study, the investigators want to learn if it is~     feasible to use this device in memory rehabilitation.~   "
64192|NCT02726750|"~     The goal of this clinical research study is to find markers that might help predict why some~     patients with monoclonal gammopathy of unknown significance (MGUS) and smoldering multiple~     myeloma (SMM) develop multiple myeloma, while others do not.~      Markers that will be studied may include participant's age, level of proteins in blood and~     urine, percent of abnormal blood cells in the bone marrow, genes in the abnormal blood cells,~     and bone abnormalities.~   "
76197|NCT02569619|"~     The purpose of this study is to determine if a manualised intervention to promote physical~     activity (MoVo-LISA) is effective to help psychiatric outpatients to increase their level of~     everyday physical activity.~   "
64194|NCT02726724|"~     The Endotracheal intubation (ETI) of a neonate is a procedure that usually attracts a large~     number of observers. The fear of being judged by others could cause an increased level of~     stress, especially on the junior trainees. Little research has focused on the effect of the~     audience on the level of stress and therefore, on the success rate of complicated procedures~     in neonatal intensive care.~      Hypothesis:Investigators hypothesize that time to successful intubation (in seconds) will be~     longer with the presence of observers.~   "
64195|NCT02726711|"~     The purpose of this study is to learn more about the regulation of the veins of the abdomen~     by the autonomic (involuntary) nervous system, and how this may affect high blood pressure.~     Normally, the autonomic nervous system controls how much blood flows in the veins. In people~     with high blood pressure, however, the autonomic nervous system is changed. This change may~     affect the way blood flows in the veins of the abdomen which may play a role in their high~     blood pressure. About 32 participants will be screened for the study. The investigators~     estimate 16 will be eligible to participate in all of the study days.~   "
64196|NCT02726698|"~     The purpose of this study is to study clinical factors and (blood) biomarkers related to~     progression of Atrial Fibrillation (AF) in patients diagnosed with self-terminating AF with~     special reference to hypercoagulability. All patients will be continuously monitored for~     their atrial rhythm to assess AF progression, either through an implantable loop recorder~     (Reveal LinQ) or via the atrial lead of a cardiac implantable electronic device (CIED), both~     in combination with the CareLink home monitoring system. Remote monitoring and interrogation~     will be installed and used on a daily basis.~   "
64197|NCT02726685|"~     The purpose of the research is to investigate the effects of respiratory training on~     respiratory and functional performance in patients with stroke.~   "
64198|NCT02726672|"~     The purpose of this study is to assess the effect of a training of the inspiratory muscles~     against resistance at home during 10 weeks in multiple sclerosis patients with a severe~     disability.~   "
64199|NCT02726659|"~     The investigators will conduct a 6-week, randomized, double-blind, placebo-controlled trial~     of celecoxib as an add-on treatment to the mood stabilizer among women with bipolar I or II~     postpartum depression. Women who are taking a mood stabilizer for treatment of bipolar~     disorder in the postpartum treatment will receive either a placebo or celecoxib add-on~     treatment. Patients will be monitored regularly to assess psychiatric symptoms and side~     effects. The investigators aim to evaluate the potential antidepressant effect of celecoxib~     in bipolar postpartum depression.~   "
64200|NCT02726646|"~     Summary The aim of this study is to evaluate through clinical, microbiological and~     immunological parameters using PLGA microspheres (lactic-co-glycolic acid polyacid)~     containing doxycycline in periodontal therapy in smokers with chronic periodontitis. For this~     study, 40 patients will be selected, with an average age between 30 and 59 years old of both~     genders (male and female), who spontaneously seek the clinic graduate of the Piracicaba~     Dental School -FOP / UNICAMP, and exhibiting at least four bleeding sites, including 2 sites~     with a probing depth (PD) between 5 and 6 mm and two sites PS ≥7 mm in uniradiculares teeth.~     Patients should have a minimum of 20 teeth. Will be excluded from relevant systemic disease~     carriers or antibiotics used in the 6 months preceding the study. All patients will receive~     oral hygiene instruction and will undergo a pre-treatment, which will be held supragingival~     sweeps and removal of plaque retentive factors. Patients will be divided into 2 groups (DB +~     DOX: Debridement + Doxycycline, test group and DB: only debridement, control group) of 20~     patients who will receive the following treatments: periodontal debridement ultrasound for 45~     minutes associated with the local administration of 1 mg microspheres containing doxycycline,~     or just mechanical debridement, for each selected site. Will be assessed the following~     clinical parameters: gingival index (GI) Plaque Index (PI), Bleeding on Probing (BOP),~     Position of the gingival margin (PGM), Probing Depth (PD) and Relative Clinical Attachment~     Level (RCAL). The microbiological evaluation will be made by means of polymerase chain~     reaction - real time ( real time - PCR) to detect bacteria: Porphyromonas gingivalis,~     Tannerella forsythia, Treponema denticola, Aggregatibacter actinomycetemcomitans and~     Prevotella intermedia. The enzyme immunoassay (LUMINEXMAGPIX) allow the detection of cytokine~     levels of GM-CSF, INF-γ, IL-10, IL-12, IL-13, IL-1β, IL-4, IL-6, IL-8 and TNF-α. The analysis~     of the proteolytic enzyme activity is accomplished by using zymography to assess MMP-8 and~     MMP-9. The described parameters will be evaluated at baseline, 45 and 90 days after the~     initial visit. The results are compared statistically by analysis of variance with repeated~     measures with 5% significance level.~   "
64201|NCT02726633|"~     A Study to evaluate the utility of the ProLung China Test as an adjunct to CT scan in the~     diagnosis of lung cancer.~   "
64202|NCT02726620|"~     The purpose of this study is to determine whether a decision support system can improve the~     adherence to thresholds for low blood pressure by anesthesia providers, which in turn~     prevents their patients from having organ injury.~   "
64203|NCT02726607|"~     The purpose of this study is to modify the HITSystem to engage and retain HIV+ pregnant women~     before, during and after delivery and evaluate the HITSystem impact on prevention of~     mother-to-child transmission (PMTCT) related behaviors and outcomes. HITSystem 2.0~     intervention will support a range of PMTCT outcomes including retention in care, ART~     adherence, and integration of maternal and pediatric HIV services in low-resource settings.~   "
64204|NCT02726594|"~     The aim of this prospective monocentric study is to evaluate the patient comfort in MRI and~     to measure examination conditions and factors that may affect the image quality and thus the~     diagnostic accuracy. For this purpose a total of 1000 participants enrolled in the study,~     consisting of healthy volunteers (N = 300) as well as patients (N = 700), that are assigned~     to the clinically indicated MRI scan. In this study, individual regions of the body are~     studied by MRI (for example, knee, ankle, head or spine). For all participants of the study,~     the investigation for each region examined is exactly the same except that a single external~     factor is changed or is different. Such variable factors may include: the tube diameter of~     the magnet, weight of the coil, which is closely attached to the examined area of the body,~     the height adjustment of the table on which the participants lie, the duration of the study~     protocol and the generated volume during the investigation. Participants are involuntarily~     subjected to the particular MRI scanner and setting by availability of USZ Radiology~     disposition. For the evaluation of the data, participants will be matched in terms of the~     body regions being examined and based on being part of the patient or subject group. Due to~     the fine different experimental conditions, the influence of these factors on study patient~     comfort, as wells as the image quality and thus the diagnostic accuracy will investigated. By~     this approach, the relevant factors will be examined in isolation. Only by exploring the~     patient's perception/comfort during an MRI scan, the patient-orientated design of the study~     conditions can be improved and thus the possibilities of modern MRI technology can be fully~     utilized in clinical practice.~   "
64205|NCT02726581|"~     The purpose of this study is to evaluate the safety and effectiveness of several combination~     therapies for Multiple Myeloma. Upon entry into the study, patients will be randomized~     (assigned by chance) to receive either:~      Group 1: nivolumab, pomalidomide and dexamethasone OR Group 2: pomalidomide and dexamethasone~     OR Group 3: nivolumab, elotuzumab, pomalidomide and dexamethasone. Enrollment is closed for~     Group 3.~      There is an equal chance to be assigned to either Group 1 or Group 2. Group 3 is no longer~     open for enrollment.~   "
64206|NCT02726568|"~     This trail is to designed to assess the efficacy and safety of high dose Iconitib for NSCLC~     patients harboring EGFR mutation with brain metastases.~   "
64207|NCT02726555|"~     Double-dose statin regimen achieves merely 6% of decrease in low-density lipoprotein~     cholesterol (LDL-C) levels, whereas the risk of side effects increased largely. The~     investigators' previous pilot study (NCT01686451) has suggested that red yeast rice was of~     similar lipid-lowering efficacy while was associated with less fatigue than statins. The~     purpose of this study is to evaluate the efficacy and safety of combined therapy with red~     yeast rice and low-dose atorvastatin in persons with mild atherosclerotic cardiovascular~     disease and who qualified for statin therapy according to national guidelines.~   "
64208|NCT02726542|"~     Fatty liver disease is an increasing problem in overweight and obese young adults. The~     purpose of this study is to test the effect of growth hormone on liver fat in obese young~     adults ages 18-29y with increased liver fat.~   "
64209|NCT02726529|"~     The purpose of the research is to find out how well a new nutrition program works for~     elementary school students and their families. This program is called Brighter Bites.~     Brighter Bites is a school-based program that teaches students and their parents about the~     importance of eating fresh fruits and vegetables and how to prepare them in tasty, healthy~     ways. This project is being carried out at six elementary schools in Houston, Texas. Up to~     600 first grade students and their parents/guardians are expected to join this project.~   "
64210|NCT02726516|"~     Compare a dietary supplement (PRJ-205) and placebo during 1 or 4 days on aerobic exercise~     performance, oxidative stress and muscle damage.~      The hypothesis is that supplementation with PRJ-205 improve aerobic performance~   "
64211|NCT02726503|"~     The purpose of this phase Ⅱ study is to assess the efficacy and safety of lenvatinib for~     anaplastic thyroid cancer patients who are diagnosed as unresectable. The total duration of~     the study will be 30 months. All patients will start administration of lenvatinib within 1~     week of enrollment and receive the study drug 24mg orally once daily at almost the same time.~     1 cycle consists of 4 weeks. Treatment term starts on the day 1st of drug administration of~     cycle 1 and administration will be continued until patients meet withdrawal criteria. Safety~     and efficacy assesment will be conducted on a regular basis during the trial. Tumor~     evaluation will be conducted at 4weeks, 8 weeks, 12 weeks, 16 weeks and at every 8 weeks~     after the 16th week since initial administration. When study drug administration~     terminated,tests of the drug termination will be conducted within 7 days of withdrawal and~     final observation will be conducted at 30 days after the last dose. Survival survey will be~     conducted at follow-up term. After the termination of the study drug, survival follow up~     survey will be conducted every 12 weeks unless patients withdraw enrollment of this study.~   "
64212|NCT02726490|"~     A randomized comparison of glyburide to glucovance (metformin -glyburide) in the management~     of diabetes in pregnancy.~   "
64213|NCT02726477|"~     The purpose of this study is to assess the efficacy and safety of Wuling San, a traditional~     Chinese medicine, in reducing arm volume excess in women with stage I-II breast cancer~     related unilateral lymphedema.~   "
64214|NCT02726464|"~     This is an observational study that evaluates the characteristics of Platelet Rich Plasma~     used in the therapy and treatment of musculoskeletal injuries and degenerative joint~     diseases.~      A sample of the PRP will be tested for platelet and microparticle content using dynamic light~     scattering to determine if there is a relationship between the composition and the treatment~     outcome.~   "
64215|NCT02726451|"~     The primary objective of this study is to determine the efficacy of Sensi Peel®, Rejuvenating~     Serum, and the C&E Strength Max skin care products in subjects who undergo full facial~     rejuvenation, with a botulinum neurotoxin A and/or hyaluronic acid filler, in improving the~     appearance of the skin, patient satisfaction with aesthetic appearance, and the projected~     first impressions.~      The secondary objective of this study is to examine patient satisfaction with the continuous~     use of Sensi Peel®, Rejuvenating Serum, and the C&E Strength Max products.~   "
64216|NCT02726438|"~     Debio 1450 is being developed for the treatment of staph (staphylococcal) infections. How~     fast and completely an antibiotic penetrates into bone is used to determine how effective it~     might be to treat infections related to bones or joints. Since bone has fewer blood vessels~     than other tissue (for example lung tissue or the skin), drugs have a harder time getting~     into them. It is important to find out how much of the antibiotic can get into the bone to~     help patients with bone infections.~   "
64217|NCT02726425|"~     This study evaluates the comparative effectiveness of a diabetes self management (DSM) group~     medical visit in the virtual world (Second life) verses a face-to-face format, aimed to~     increase physical activity and improve glucose control among Black/African American and~     Hispanic women with uncontrolled diabetes mellitus.~   "
64218|NCT02726412|"~     This study aims to describe the postoperative functions of patients with ischaemic lower~     extremities after undergoing revascularisation surgery . Primary endpoints will focus on~     complications in the post-anaesthesia care unit (PACU) which prevent discharge from PACU to~     the general ward. This include Aldrete scores and other complications that can be registrered~     descriptively. Furthermore, the study seeks to compare the complications outcomes between~     acute and elective revascularisation surgery.~   "
64219|NCT02726399|"~     The purpose of this study is to compare any good and bad effects of using ramucirumab along~     with the usual trastuzumab and chemotherapy to using the usual chemotherapy and trastuzumab~     alone.~   "
64220|NCT02726386|"~     This is a multi-center, international, open-label, safety study of ND0612, a solution of~     levodopa/carbidopa (LD/CD) delivered via a pump system as a continuous SC infusion in~     subjects with advanced Parkinson's Disease.~   "
67662|NCT02681315|"~     This is a randomized controlled trial (RCT) to evaluate the influence of two flow rates (6~     liter/min versus 3 liter/min) of Heated-Humidified High-Flow-Nasal-Cannula (HHHFNC) on rates~     of extubation failure in mechanically ventilated preterm infants.~   "
64221|NCT02726373|"~     Objective: To compare effects of an intermittent and continuous walking program on walking~     endurance and fatigue in people with multiple sclerosis (MS).A randomized crossover~     prospective method was used.The intervention consisted of eight 6-minute-long walks (2x/week~     for 4 weeks). The continuous condition consisted of 6 continuous minutes of walking. The~     intermittent condition consisted of three 2-minute bouts with 2-minute rests. After a 4-week~     detraining period, participants performed the second training condition.~   "
64222|NCT02726360|"~     The purpose of this study is to test a method for analyzing interactions between patients and~     doctors, the Roter Interaction Analysis System (RIAS). The RIAS measures the quality of~     communication between patients and their cancer doctors.~   "
64223|NCT02726347|"~     The study is looking at the pneumonia vaccine and the immune system response to this vaccine.~     The information gathered from this study may be important for your doctor to take care of~     patients with smoking histories, immune deficiency, asthma, Chronic Obstructive Pulmonary~     Disease (COPD), or elderly patients. It is important that your immune system builds a strong~     defense to the vaccine so that you are better able to fight a bacterium that can cause~     pneumonia. Some disease prevent the immune system from building a strong defense and these~     patients will not benefit from the vaccine.~   "
64224|NCT02726334|"~     The purpose of this study is to determine the maximum tolerated dose (which will be the dose~     recommended for a Phase 2 study), safety, tolerability and pharmacokinetic profile (study of~     movement of the drug within the body, including absorption and distribution) of the study~     drug, BNC101 when administered intravenously as a single agent or in combination with~     chemotherapy in patients with metastatic colorectal cancer who have failed at least 1 or 2~     lines of chemotherapy.~   "
64225|NCT02726321|"~     Background: Atherosclerotic carotid intima-media thickness (IMT) may be associated with~     alterations in the sensitivity of carotid and subclavian baroreceptors.~      Aim: The aim of this study is to investigate if carotid IMT is associated with changes in the~     autonomic modulation of the heart rate variability (HRV).~      Methods: This is a prospective cross-sectional study. The carotid IMT is determined by B-mode~     and duplex ultrasonography. The cardiovagal function was determined through linear and~     nonlinear measures of HRV. Linear regression models, adjusted for demographics,~     comorbidities, body mass index, waist-hip-ratio, and left ventricular ejection fraction will~     be used to evaluate the association between HRV parameters and carotid IMT.~   "
64226|NCT02726308|"~     Postoperative nausea and vomiting (PONV) are the most common and distressing side effects~     following Laparoscopic cholecystectomy~   "
64227|NCT02726295|"~     Chronic constipation is a prevalent, burdensome gastrointestinal disorder whose treatment~     remains challenging. There exist effective pharmacological therapies for chronic~     constipation, however, many patients do not well respond to current medications. Evidence~     suggests that disturbance in the gastrointestinal microbiota may be implicated in chronic~     constipation. Although, E.coli Nissle 1917 (Mutaflor®) has been used for chronic~     constipation, there are limited data regarding the efficacy of E.coli Nissle 1917 (Mutaflor®)~     in these patients. Therefore, this study aimed to investigate the efficacy of E.coli Nissle~     1917 (Mutaflor®) in patients with chronic constipation.~   "
64228|NCT02726282|"~     To explore how a clinical sample of patients with thyroid nodules (men and women) with no~     history of thyroid cancer would make decisions about treatments based on different~     terminology used to describe papillary thyroid cancer (with and without the cancer term).~   "
64229|NCT02726269|"~     The goal of this trial is to compare the non-inferiority efficacy and safety of two different~     treatment schemes: pantoprazole 80 mg + levofloxacin 500 mg + azithromycin 500 mg once daily~     (PLA, test) vs. clarithromycin 500 mg + lansoprazole 30 mg + amoxicillin 1 g twice daily~     (CLA, reference), each during 10 days, over Helicobacter Pylori (HP) eradication. Both~     schemes will be tested in treatment-naive patients, with biopsy-based diagnosis for HP~     infection. One month after finishing each treatment, C13-urea breath testing will be required~     to verify HP eradication. Biopsies will also be taken to identify Clarithromycin-resistance~     mutations in HP strains by fluorescence in situ hybridization (FISH).~   "
64230|NCT02726256|"~     The prevalence of type 2 diabetes has consistently increased and type 2 diabetes can cause~     many types of vascular complications. Diabetes develops due to glucose intolerance. Early~     detection and intervention in the stage of glucose intolerance makes it afford to prevent~     overt diabetes and its complications. This study was designed to make a cohort of korean~     patients with glucose intolerance to construct a long term database about clinical~     characteristics of these patients.~   "
64231|NCT02726243|"~     Build a collection of fecal microbiota in order to determine the characteristics of gut~     microbiota associated with colorectal cancer in Inflammatory bowel disease (IBD).~   "
64232|NCT02726230|"~     Ananya was funded by BMGF to reduce maternal, newborn, and child mortality; fertility; and~     child undernutrition in Bihar, India. Ananya involved multi-level interventions designed to~     build front line health worker (FLW) capacities and reach to communities and households, as~     well as to strengthen public health facilities and quality of care to increase maternal and~     neonatal care and health behaviors, and thus survival. From 2012 to 2014, eight focal~     districts in western and central Bihar.received Ananya, while 30 districts did not. Data were~     collected from mothers of infants 0-11 months at baseline and mothers of infants 0-23 months~     at 2 year follow-up, from comparable public health blocks in Ananya and Control districts to~     assess Ananya effects on quality and quantity of FLW home visits, postnatal health behaviors,~     and among older infants/toddlers, complementary feeding and vaccination. Difference in~     difference analyses were used to assess Ananya outcome effects in this quasi experimental~     study.~   "
64233|NCT02726217|"~     CareSmarts is a theory-driven behavioral intervention designed to improve self-care among~     patients with Type 2 diabetes (T2D) with poor glycemic control (HbA1c>8%), through multiple~     mediators, including cuing, education, self-efficacy, social support, and health beliefs.~     Individuals will be randomly assigned with equal allocation to either the CareSmarts~     intervention or to usual care for 6 months.~   "
64234|NCT02726204|"~     The purpose of this study is to investigate how the cable-driven arm exoskeleton (CAREX) can~     assist task performance during 3D arm movement tasks under various experimental conditions in~     healthy individuals and patients with stroke. This study is designed to test motor learning~     with the robotic rehabilitative device CAREX under three conditions in healthy subjects and~     subjects with post-stroke hemiparesis.~   "
64236|NCT02726178|"~     Background: Inflammation may depress respiration in neonates. The aim of this study was to~     establish a link between post-immunization inflammation and cardio-respiratory events (CRE).~      Methods: Randomized double-blind controlled study of infants born <32 weeks gestation~     receiving the 2 months vaccine. Infants were randomized into an ibuprofen treatment group and~     a placebo control group. C-reactive protein (CRP) and prostaglandins E2 (PgE2) levels were~     assessed before and after immunization. CRE were recorded for 72 hours. Heart rate~     variability (HRV) was assessed by polysomnography.~   "
64237|NCT02726152|"~     The investigators propose a study to compare two methods of closing the stump of the appendix~     during an emergency excision of the appendix using a keyhole approach. One similarly designed~     study has been undertaken in another institution but there were not enough patients recruited~     to the study to allow meaningful conclusions to be drawn.~      Any patient over the age of 16 years whom the investigators suspect to have acute~     appendicitis will be considered for recruitment to the study. During their exploratory~     keyhole surgery, if the surgical team feels that excision of the appendix is indicated then~     the patient will be randomly allocated to either polymer clips or endoloops to the part of~     the procedure where the stump (base) of the appendix is closed.~      The main aim is to determine if polymer clips shorten the duration of the operation. The~     investigators will also determine if there is a difference between the rates of~     complications, the time spent in hospital and the number of times the participants had to be~     readmitted to hospital within 30 days.~   "
64238|NCT02726139|"~     Commercial one and two-stage factor VIII assays may not detect some clinically significant~     inhibitor antibodies. The purpose of the proposed study is to standardize and validate a~     platelet-based factor VIII activity assay with greater sensitivity to clinically important~     inhibitory antibodies. Investigators will evaluate the platelet-dependent inhibitory activity~     vs. conventional inhibitory activity in stored patient plasmas and correlate to bleeding~     histories~   "
64239|NCT02726126|"~     Seventy five patients, aged 18-50 years, ASA I and II undergoing elective single level lumber~     laminectomy under general anesthesia were included in this randomized controlled double-blind~     study. Patients were randomly divided into 3 groups 25 each, C group patients received~     transdermal placebo patch, TDF group (50μg/h) and TDM group (7 mg). Assessment of~     postoperative pain, sedation, hemodynamic variables such as HR and MAP, postoperative~     monitoring of arterial SpO2 and side effects (e.g. nausea, vomiting, pruritis, respiratory~     depression and hemodynamic instability) were done 30 minutes, 1, 2, 6 and 12 hours~     postoperatively. Postoperative Patient`s and Surgeons` satisfaction, Intraoperative bleeding~     and plasma cortisol (µg / dl) postoperatively were also assessed.~   "
64240|NCT02726113|"~     The study population will be 80 adult men who have been diagnosed with prostate cancer who~     are scheduled to have their prostate surgically removed at either the Medical University of~     South Carolina (MUSC) or the Ralph H. Johnson VAMC, both located in Charleston, SC. The men~     will be randomized into two groups: one group will take vitamin D3 supplementation and the~     other will take a placebo. Blood levels of vitamin D3 will be obtained at the beginning of~     the study and again after two months, just prior to the surgical procedure (prostatectomy).~     Prostate tissue will be obtained from the surgical procedure and studied for the effect of~     vitamin D on the prostate cancer cells.~   "
64241|NCT02726100|"~     It's a community-based parallel-arm cluster Randomized Controlled Trial (RCT). An interactive~     mobile health management system will be developed to support lay family health promoters and~     healthcare staff to improve clinical outcomes for family members with Type 2 Diabetes~     Mellitus (T2DM). 2,000 participants from 80 sites will be chosen from urban (40 communities)~     and rural (40 villages) settings in Shijiazhuang City, Hebei Province.~   "
64242|NCT02726087|"~     This is a single-center, single-blind, all comer, randomized controlled trial. Patients~     scheduled for isolated aortic valve replacement (AVR) due to aortic stenosis at Virgen de la~     Victoria Universitary Hospital, Málaga, Spain, will be eligible. Ninety-six patients will be~     randomly assigned to either partial upper sternotomy (ministernotomy, 48 patients) or full~     sternotomy AVR (48 patients). Sample size was determined for an Alpha error of 0.05,and Beta~     error of 0.1 for a power of 90% in detecting 0.10 difference points in quality of life~     EQ-5D-5L-index or 10 points in EQ-5D-5L-Visual Analogic Scale (QOL).~   "
64243|NCT02726074|"~     This is a multi-center, open-label, single-arm, phase 4 study to evaluate the efficacy of~     perampanel added to monotherapy for partial onset seizures with or without secondarily~     generalized seizures (total seizures).~   "
64244|NCT02726061|"~     The investigators have developed an interactive, multimedia computer-based depression~     treatment program (Dartmouth Research Problem Solving Therapy; DrPST). DrPST is based on an~     evidence-based psychotherapy called Problem Solving Therapy in which depressed patients~     identify problems in their lives and work through a structured format for solving these~     problems. The investigators have subjected DrPST to Phase 1-3 feasibility, acceptability and~     efficacy trials which have been positive and without adverse events. The purpose of the~     current study is to make DrPST available through the Employee Assistance Program (EAP) at~     Dartmouth-Hitchcock Medical Center and the Faculty and Employee Assistance Program (FEAP) at~     Dartmouth College in order to assess the feasibility, acceptability and effectiveness under~     naturalistic conditions.~   "
64245|NCT02726048|"~     This investigation is designed to evaluate the performance, comfort and ease of use of the~     Simplus and Eson masks amongst NIV patients who are currently on Bi-level therapy~   "
64246|NCT02726035|"~     The proposed study examines the effect of oral naltrexone on self-injurious behavior (SIB) in~     adolescents and adults of normal intelligence.~   "
64247|NCT02726022|"~     Participants with Chronic Hepatitis C (CHC) and normal ALT, who have been under treatment~     with peginterferon alfa-2a and ribavirin for at least 4 weeks, will be enrolled into this~     non-interventional, open-label study. The primary aim is to evaluate quality of life~     according to the 36-Item Short-Form Health Survey (SF-36) questionnaire, modified for the~     Greek population.~   "
64248|NCT02726009|"~     The purpose of this open-label, single-arm, multicenter, post-marketing trial is to evaluate~     long-term safety of Firmagon® in approximately 230 Indian patients diagnosed with advanced~     hormone-dependent prostate cancer requiring androgen deprivation therapy.~   "
64249|NCT02725996|"~     To prove that the efficacy and safety of 'NK group' is superior to 'non-treatment~     group(Control group)' in patient undergone curative resection(RFA or operation) for~     hepatocellular carcinoma in China.~   "
64252|NCT02725957|"~     This will be a double-blind, randomized, placebo-controlled, single ascending dose study~     performed in healthy subjects.~      The study will include up to four escalating dose cohorts with eight (8) subjects in each~     cohort.~      In each cohort, eligible subjects will be randomized in a 3:1 ratio to receive single IV~     administration of 9% trehalose (Treatment Arm 1) or placebo (Treatment Arm 2).~      All subjects, regardless of their treatment arm assignment, will undergo the same evaluations~     and will receive the study drug at the clinic. Each subject will continue to be followed for~     one week post dosing.~   "
64253|NCT02725944|"~     PROACTIA is a prospective, event-driven observational study. It aims to propose a composite~     scoring system in order to evaluate the risk of paroxysmal atrial fibrillation (PAF) in~     patients after acute cryptogenic stroke and transient ischemic attack (TIA).~   "
64254|NCT02725931|"~     The aim of this study is to investigate whether providing feedback on physical activity (PA)~     levels to patients with Chronic Obstructive Pulmonary Disease (COPD) is feasible and enhances~     daily PA and health-related outcomes during pulmonary rehabilitation (PR).~      Patients will participate in a 12-week PR program and a PA-focused intervention. Patients'~     daily PA will be monitored during the first (W1), seventh (W7) and 12th (W12) weeks of the PR~     program using the activity monitors GT3X+ (ActiGraph, Pensacola, FL) and feedback will be~     given to them in the following weeks. Each participant will also receive individualised~     recommendations to improve or maintain their PA levels, based on the results of the previous~     week.~      It is expected that, by receiving individualised feedback and goals regarding their PA levels~     during the PR program, patients with COPD will become more active and improve their~     health-related outcomes.~   "
64255|NCT02725918|"~     The study is a prospective, multi-center, open-label, randomized, and controlled phase II~     clinical trial. The investigators hope to figure out the better chemotherapy regimen for the~     post-EGFR-TKI failure setting. The primary objective of this trial is to compare~     progression-free survival without grade 4 (G4PFS) toxicities between pemetrexed-cisplatin and~     single-agent pemetrexed treatment arms.~      The trial will include stage IIIB/IV EGFR mutation positive NSCLC patients who got disease~     progression after front-line EGFR TKI treatment.Eligible patients will be randomized to 2~     arms. Patients in arm A will receive 4 cycles of cisplatin (75 mg/m2, d1) and pemetrexed (500~     mg/m2, d1) every 3 weeks, those without disease progression (PD) and being tolerable judged~     by investigator will continue single-agent pemetrexed (500 mg/m2, d1) every 3 weeks as~     maintenance until progression or intolerable toxicities. Patients in arm B will receive~     pemetrexed (500 mg/m2, d1) every 3 weeks until PD or intolerable toxicities.~   "
64256|NCT02725905|"~     Eight U.S. medical schools will be participating in the study: Weight Management Counseling~     in Medical Schools, also known as MSWEIGHT. This is a five-year randomized controlled trial~     (RCT) designed to compare the efficacy of two approaches to learning weight management~     counseling: 1)traditional education (TE) and; 2) multi-modal educational intervention (MME).~      The study aims are to refine and compare the efficacy of MME to TE on observed student weight~     management counseling skills measured through the primary outcome, the Objective Structured~     Clinical Examination (OSCE).~   "
64257|NCT02725892|"~     National, prospective, multicentric, non-interventional registry-based study, conducted among~     oncologists, pulmonologists in community and university hospitals, from the public sector in~     Algeria.~      The study will collect information on the characteristics, and lung carcinomas patterns of~     patients whose lung cancer diagnosis was confirmed by a pathologist during the study period.~   "
64258|NCT02725879|"~     Thyroid hormone (TH) and fibroblast growth factor 21 (FGF-21) are reported to share common~     metabolic pathways and underlying mechanisms in terms of energy balance, thus affecting both~     thermogenesis and resting metabolic rate (RMR). Although FGF-21 levels has been studied in~     children and adolescents regarding obesity, body composition and insulin resistance, data in~     children and adolescents diagnosed with Hashimoto's thyroiditis are lacking. Therefore, the~     purpose of this study is to measure the RMR in children and adolescents diagnosed with~     clinical hypothyroidism due to thyroiditis Hashimoto just before starting levothyroxine~     treatment and after six months achieving an euthyroid state, and to detect any association~     between serum FGF-21 levels and RMR.~   "
64259|NCT02725866|"~     The interferon-free combination regimen of Paritaprevir/r - Ombitasvir with or without~     Dasabuvir (ABBVIE REGIMEN) ± Ribavirin (RBV) for the treatment of chronic hepatitis C (CHC)~     has been shown to be safe and effective in randomized controlled clinical trials with strict~     inclusion and exclusion criteria under well controlled conditions.~      This observational study is the first effectiveness research examining the ABBVIE REGIMEN ±~     RBV, used according to local label, under real world conditions in Greece in a clinical~     practice patient population.~   "
64260|NCT02725853|"~     Many people who have had a stroke have problems recovering the use of their affected arm and~     these problems may persist for a long time. The investigators' research will test new ways to~     boost recovery by using non-painful brain stimulation together with training of arm movements~     using basic science principles. The training program will be done using the latest technology~     in rehabilitation such as virtual reality and robotics. The investigators will compare three~     groups of patients who have had a stroke. Each group will receive different combinations of~     brain stimulation and arm training. Another aspect of this proposal is that the investigators~     will do the same training programs in three different countries - Canada, Israel and India.~     In this way, the investigators will combine knowledge and skills to create training programs~     that can be applied anywhere in the world and that are not necessarily limited to high-income~     countries. Also, by combining expertise, the investigators will help to build the capacity to~     do research in India, a middle-income country that has great potential to contribute new~     knowledge to rehabilitation medicine.~   "
64273|NCT02725684|"~     The purpose of this study is to assess whether the use of genomics can help identify patient~     specific treatment choices in cancer. In order to test this, the investigators plan to use~     genomic sequencing technology to identify patient specific mutations in glioblastoma~     multiforme (GBM) as compared to normal cells to identify mutations. Further analysis will~     identify potential treatment targets and whether there are any drugs that could be used for~     these particular mutations. Follow up clinical data will be assessed to see if this~     individualized method of choosing treatment options can improve clinical outcomes in patients~     with GBM.~   "
64261|NCT02725840|"~     Through improved early detection and treatment, the number of long term breast cancer~     survivors continues to increase. There are now 2.8 million breast cancer survivors in the~     U.S. Florida alone adds over 9,000 women to the survivorship pool each year. Most receive~     radiation treatment (RT) of the affected breast and chest wall to reduce risk of recurrence.~     Even with advanced radiation techniques for dose conformality to minimize exposure of the~     highly sensitive lung, 14% of breast cancer patients treated with radiation develop clinical~     pulmonary toxicity, with 4% overall experiencing high grade clinical toxicity. Early~     diagnosis and intervention to mitigate lung radiation toxicity is increasingly important for~     the long term care of these survivors.~      The investigators' goal is to better identify breast cancer patients at high risk for~     experiencing severe pulmonary toxicity requiring medical intervention, provide a means to~     identify toxicity early on, and tailor treatment and/or early intervention on a per-patient~     basis.~   "
64262|NCT02725827|"~     This is a randomized-controlled trial evaluating the effect of the use of hyaluronan~     (HA)-enriched embryo transfer medium on the live birth rate in women undergoing frozen-thawed~     embryo transfer. For half of the women, hyaluonan-enriched medium will be used as embryo~     transfer medium. For the other half of women, control will be used.~   "
64263|NCT02725814|"~     Recent studies show that babies in hospital undergo an average of 4 to 5 painful procedures,~     such as heel lances, every day. Sucrose (sugar water) has been shown to be effective for~     reducing babies' pain during painful procedures. Unfortunately, sucrose is not used as often~     as it could be to reduce babies' pain. This may be due to lack of certainty about the least~     effective amount of sucrose to use and concerns about the long-term effects of repeated use~     of sucrose on infant development. Factors within the hospital units where babies receive care~     may also influence caregivers' decisions to use sucrose. In this research the investigators~     will conduct two main studies. In the first study the investigators determined the lowest~     amount of sucrose needed to manage babies' pain effectively. In the second study the~     investigators will explore (a) if this amount of sucrose can manage pain when it is used~     repeatedly for all painful procedures while the baby is hospitalized and (b) whether~     consistent use of sucrose influences the development of babies when they are 18 months old.~     During the second study, the investigators will also examine the hospital units where the~     babies receive care. They will look at staff support for research, time and resources and~     other factors that promote and prevent sucrose use. The results of these studies will be used~     to determine the best management of babies' pain during painful procedures in hospitals to~     achieve the best outcomes.~   "
64264|NCT02725801|"~     Appropriate patients undergoing going immediate breast reconstruction with tissue expanders~     following mastectomy will be randomized to receive one-port or two-ports tissue expanders.~     Their clinical course, complications, and outcome will be analyzed.~   "
64265|NCT02725788|"~     A multi-center randomized control trial comparing the dressing wear times of two different~     transparent film dressings when used to secure peripheral intravenous catheters of~     hospitalized adult patients.~   "
64266|NCT02725775|"~     This study is a 10-week intervention study to examine the acute and chronic effects of daily~     intake of a 100 % orange juice drink vs control drink on cognitive performance. The study~     aims to determine if there are any benefits of whole orange juice intake on cognitive~     performance acutely (i.e. an improvement in performance at week 1) and chronically (i.e. an~     improvement in performance at week 10).~   "
64267|NCT02725762|"~     The purpose of this research study is to determine if photobiomodulation is an effective~     treatment of Dry Age-Related Macular Degeneration (AMD) and vision loss associated with the~     disease.~   "
64268|NCT02725749|"~     Objectives: The objective was to compare low level laser therapy (LLLT) therapy versus low~     LLLT therapy in combination with an exercise or exercise only on pain, range of motion (ROM),~     functionality, and activity limitation in patients with subacromial impact syndrome.~      Design: Randomized and placebo-controlled clinical trial.~      Setting: The setting for the study was the Municipal Clinic of Barueri, São Paulo, Brazil.~      Participants: 60 patients with subacromial impact syndrome were randomly assigned in three~     groups.~      Interventions: Group I, experimental (n=21) treated with low level laser therapy and~     exercises; Group II, experimental (n=21) treated with exercises; and Group III, experimental~     (n=18) treated with low level laser therapy. Laser used were GaAs (904 nm, 60 mW), in~     continuous emission. The participants received application of laser three times or week for~     eight weeks, on 9 shoulder points (3 Joules/point) per session.~      Main outcome measures: Visual Analogic Scale (VAS) score, Shoulder Pain and Disability Index~     (SPADI), goniometer, Modified-University of California at Los Angeles Shoulder Rating Scale~     (UCLA), recorded before and after treatment.~   "
64269|NCT02725736|"~     To compare the tocolytic efficacy oxytocin receptor antagonist (Atosiban) with that of~     calcium channel blockers (Nifedipine) among women with multiple gestation who present with~     threatened preterm labor.~   "
64270|NCT02725723|"~     Spinal stenosis is a prevalent diagnosis, which is handled in a heterogeneous manner by~     clinicians. Moreover, when using steroidal epidural injections, successful treatment is~     currently defined as the satisfaction of the patient from the treatments, a subjective and~     non-quantifiable indicator.~      In this experiment, the investigators aim to evaluate thermographic images as an objective~     method for assessing the efficacy of steroidal epidural injections, the most common invasive~     treatment for pain associated with spinal stenosis~   "
64271|NCT02725710|"~     This is a randomized controlled double-blind placebo-controlled trial evaluating the impact~     of gabapentin given preoperatively on perioperative pain scores for women receiving uterine~     aspiration between 6 and 14+6 weeks gestation. This study will be a trial included in a~     prospective meta-analysis evaluating the use of gabapentin on perioperative pain in the~     abortion setting.~   "
64272|NCT02725697|"~     The purpose of this observational study is to investigate the treatment of complaints~     following sports injuries with Traditional Chinese Medicine by therapists in Switzerland.~   "
64300|NCT02725333|"~     Background: There is no evidence that shoulder stabilization effectively corrects the~     glenohumeral translation in unstable shoulders, explaining residual apprehension in certain~     patients. The purpose of this study was to analyze the effect of surgical stabilization on~     glenohumeral translation.~      Methods: Anteroposterior and superoinferior translations were assessed in patients, before~     and after shoulder stabilization, through a dedicated patient-specific measurement technique~     based on optical motion capture and computed tomography.~   "
64274|NCT02725671|"~     Cardiogoniometry is a technique to process and evaluate vectorcardiography from regular ECG~     acquisitions. Vectorcardiography has a long tradition in cardiology for providing~     comprehensive information on myocardial function and integrity. In recent years, computer~     assisted analysis has allowed automated interpretation of vectorcardiography with promising~     results in comparison to standard ECG for identifying patients with coronary heart disease.~     This study aims to investigate the utility of cardiogoniometry for noninvasively identifying~     patients who are at risk from coronary heart disease.~   "
64275|NCT02725658|"~     The purpose of this research study is to help us learn if an experimental imaging device~     called Diffuse Optical Spectroscopic Imaging (DOSI) can monitor tumor shrinkage during~     chemotherapy treatment and can predict if the tumor will respond to chemotherapy before the~     end of the treatment. This study will also help us understand the biological reason for how~     DOSI works.~   "
64276|NCT02725645|"~     The purpose of the present study is to analyze the influence of four backpack loading~     conditions (0, 10, 15 and 20% of body weight) on the electromyographic activity of the neck~     and lumbar muscles of elementary school children.~   "
64277|NCT02725632|"~     This study is designed to test whether SCN5A mRNA processing is altered in OSA patients,~     which may contribute to their increased arrhythmic risk, and whether processing of SCN5A mRNA~     is modulated by CPAP treatment.~      Specific aims:~        1. Compare sodium channel splicing variants in mild, moderate, or severe OSA patients at~          baseline to at 1 month after CPAP treatment. In addition, the baseline splicing variants~          of SCN5A in the OSA patients will be compared to an age-matched control group.~        2. Hypoxia-associated upstream regulators of SCN5a mRNA splicing, Hypoxia-inducible factor~          1-alpha (HIF-1α), RNA Binding Motif Protein 25 (RBM25) and LUC7-Like 3 Pre-MRNA Splicing~          Factor (LUC7L3), will be examined in OSA patients before and after 1 month of CPAP~          treatment.~   "
64278|NCT02725619|"~     This is a randomized controlled trial of Cognitive Behavioral Therapy (CBT) versus~     Psychoeducation and Supportive Therapy (PST) in children with Autism Spectrum Disorder and~     moderate to severe anxiety. The study will utilize fMRI to identify CBT-invoked changes in~     levels of activity/functional connectivity within the neural circuits involved in emotion~     regulation and social perception. Matched typically developing children without autism and/or~     anxiety will be scanned twice, 16 weeks apart, to enable interpretation of treatment-evoked~     change relative to normative development.~   "
64279|NCT02725606|"~     The purpose of the present trial is to evaluate the safety, tolerability and~     pharmacokinetics(PK)/pharmacodynamics(PD) of single subcutaneous injection of GW003 in breast~     cancer patients. Moreover, the efficacy will be assessed preliminary.~   "
64280|NCT02725593|"~     A trial of patients aged 10-24 years with type 2 diabetes mellitus to evaluate the~     comparative efficacy and safety between dapagliflozin and Placebo.~   "
64281|NCT02725580|"~     The proposed clinical trial is the first human, open-label, single dose study of~     self-complementary AAV9 carrying the CLN6 gene delivered one-time intrathecally inserted by a~     lumbar puncture into Batten CLN6 Disease subjects. One cohort of patients with Batten CLN6~     Disease, with confirmed diagnosis, will undergo gene transfer. A minimum of twelve patients~     will be enrolled into the cohort.~   "
64282|NCT02725567|"~     The purpose of this study is to evaluate the safety of ivacaftor treatment, and PK of~     ivacaftor and metabolites in subjects with cystic fibrosis (CF) who are <24 months of age at~     treatment initiation and have a CF transmembrane conductance regulator (CFTR) gene gating~     mutation~   "
64283|NCT02725554|"~     The purpose of this study is to illustrate the safety and effectiveness of the StimRelieve~     Halo Nerve Stimulator System in the treatment of chronic migraine. The StimRelieve Halo~     System utilizes a minimally invasive procedure to implant a neurostimulator. This technology~     includes an octopolar electrode array stimulator with an embedded receiver. The energy source~     is a small, external, rechargeable transmitter, which is worn by the patient. The StimRelieve~     Halo System eliminates the implantable pulse generator, which has been the most common reason~     for reoperation or discomfort with existing devices.~      For this study, all subjects will be randomized at enrollment into either a delayed or~     immediate continuation group. The immediate continuation group will immediately continue with~     the stimulation therapy after the 30-day trial period and will be monitored for a total of 12~     months. The delayed activation group will have their device turned off after the 30-day trial~     period for the next 3-months. At the 3-month visit, both groups be evaluated and the delayed~     activation group will have their devices reactivated.~      All subjects will immediately receive the permanent stimulator(s). The permanent stimulators~     can easily be removed if non-responders are identified. The wireless technology eliminates~     the need for externalized extensions, IPG's and thus reoperation. Additionally the outcome is~     highly dependent on placement of the stimulators. By eliminating the need for a staged trial,~     infection rates and incidence of pocket pain will decrease.~      In this study, subjects will undergo a 30-day trial in order to demonstrate effectiveness.~     Immediate activation of all devices will be done in the post-op period based on sensory~     response and subject comfort. Subjects will be seen at 14-days post-implant to assess patient~     compliance with the device, assess clinical response and to adjust programming parameters if~     not responding. Subjects will be seen at 1 month post-implant and headache diaries and~     questionnaires will be reviewed. Subjects not responding to the therapy by at least a 30%~     reduction in headache days will be deemed non-responders and will be withdrawn from the study~     and can choose to have the device removed. After the trial period, all responders will follow~     their random assignment determined at enrollment (delayed or immediate continuation). All~     subjects will be monitored for a total of 13 months. Adverse events will be monitored~     throughout the study.~   "
64284|NCT02725541|"~     This is an open label, neoadjuvant phase II study to evaluate the objective response,~     toxicity, and safety of trastuzumab emtansine in patients with newly diagnosed HER2-equivocal~     breast cancer. Trastuzumab emtansine at a dose of 3.6 mg/kg will be intravenously~     administered every 3 weeks for a total of 6 weeks. Patients who achieve a partial or complete~     response after the 6-week treatment (responders) will continue on trastuzumab emtansine for~     an additional 12 weeks.~   "
64285|NCT02725528|"~     This is a prospective, multi-centre, pragmatic randomized controlled trial to compare both~     the clinical effectiveness and cost-effectiveness of collagenase injections (CI) versus~     limited palmar fasciectomy (LPF) to determine if collagenase is a superior treatment in terms~     of improved quality of life and reducing recurrence of the disease without serious~     complications. Since collagenase injections are costly it is also important to know if this~     novel intervention is cost-effective from the patient, Ministry of Health and societal~     perspectives.~   "
64286|NCT02725515|"~     The purpose of this study is to determine the ability of XmAb5871 to maintain Systemic Lupus~     Erythematosus (SLE) disease activity improvement achieved by a brief course of~     disease-suppressing steroid therapy~   "
64287|NCT02725502|"~     Type 1 diabetes is an autoimmune disorder characterized by beta cell destruction resulting in~     insulinopenia. Currently it is being treated with insulin. Dipeptidylpeptidase inhibitors~     (DPP4 inhibitors e.g. linagliptin & sitagliptin) has been used for type 2 diabetes mellitus~     (T2DM) traditionally. Previous studies has shown that it is also effective in type 1 diabetes~     mellitus (T1DM), but the mechanism of action not well understood. This study will evaluate~     possible mechanism of action of linagliptin in T1DM patients.~   "
64288|NCT02725489|"~     In this study, the researchers want to learn more about Vigil and durvalumab in advanced~     women's cancers: 1) how much of Vigil in combination with durvalumab (MEDI4736) can be given~     with an acceptable level of side effects, 2) the effects of Vigil and durvalumab in~     combination (good and bad), 3) if Vigil will cause changes in cancer cells that may help~     durvalumab attack the cancer, and 4) whether or not Vigil and durvalumab will slow your~     cancer or stop your cancer from getting worse.~      Combining Vigil with durvalumab will allow the former to induce (or increase) the~     infiltration of activated T cells into tumors, and in addition, to enhance PD-L1 (programmed~     cell death ligand 1) expression. Consequently, the response rate of historically low or~     un-responsive cancer will be increased with the combination of Vigil and anti PD-L1.~   "
64289|NCT02725476|"~     The purpose of this Phase 2 study is to investigate the effect of XmAb5871 on IgG4-Related~     Disease (RD) activity~   "
64290|NCT02725463|"~     Although cochlear implants can restore hearing to individuals who have lost cochlear hair~     cell function, there is no adequately effective treatment for individuals suffering chronic~     imbalance, postural instability and unsteady vision due to loss of vestibular hair cell~     function. Preclinical studies have demonstrated that electrical stimulation of the vestibular~     nerve via a chronically implanted multichannel vestibular prosthesis can partially restore~     vestibular reflexes that maintain steady posture and vision. This pilot clinical feasibility~     study of a multichannel vestibular implant system will evaluate this approach in up to ten~     human subjects with bilateral vestibular deficiency due to gentamicin ototoxicity or other~     causes of inner ear dysfunction.~   "
64291|NCT02725450|"~     The main purpose of this study is to ascertain whether the application of Motor Imagery~     together with normal practice improves fine motor skills in disabled individuals.~   "
64292|NCT02725437|"~     The first-in-Japanese study B5091010 has been designed to evaluate the safety, tolerability,~     and immunogenicity of 2 antigen dose levels of C difficile vaccine when administered as one~     of two 3-dose regimens to healthy Japanese adults aged 65 to 85 years.~   "
64293|NCT02725424|"~     This is a randomized,phase II,open-label study, The purpose of this study is to determine the~     optimal treatment for patients with locally advanced Gastric/Gastroesophageal Cancer~     according to their Her-2 expression status.~      The primary endpoint of this study: pathology response rate the second endpoints of this~     study:pathology complete response rate R0 resection rate Progression-free survival ( PFS)~     Disease -free survival (DFS) Overall survival(OS) Objective response rate(ORR) Adverse~     event(AE)~   "
64294|NCT02725411|"~     This study will investigate the long-term safety and efficacy of a fixed dose of tanezumab 5~     mg and 10 mg administered subcutaneously (SC) seven times at 8 week intervals. The primary~     objective of this study is to evaluate the long term safety of tanezumab 5 mg and 10 mg~     administrated SC every 8 weeks (7 administrations). In addition, the study will evaluate the~     long term analgesic efficacy of tanezumab 5 mg and 10 mg SC administered every 8 weeks (7~     administrations).~   "
64295|NCT02725398|"~     Gastrointestinal cancer has developed into a serious health problem in China. 80%-90%~     patients were detected at middle and later stage. The five-year survival rate for advanced~     cancer patients is less than 10%. The main reason of the bad clinical diagnosis and treatment~     is that the present technical method is difficult to achieve early diagnosis. Endoscopy with~     biopsy is still the main method for confirming gastrointestinal cancer. But it is limited to~     identify early tumors and it leads to the low diagnostic rate of early tumors and the poor~     overall therapeutic effect.~      Confocal laser endoscopy (CLE) can obtain pathologic information of lesion in real time and~     improve the diagnostic rate of early tumors. Probe-based confocal laser endomicroscopy(pCLE)~     is a new technology recently. Since its laser probe is applicable to all conventional~     endoscopes, pCLE greatly increased its clinical application. However, gastrointestinal~     motility has greatly influence on pCLE imaging quality and inspection effect owing to the~     poor stability of the small probe manipulation. Scopolamine (654-2, in China) is clinically~     used to inhibit bowel peristalsis, but its effect is still not ideal and its side effects are~     common.~   "
64296|NCT02725385|"~     This research trial studies stress and coping in caregivers of younger patients with cancer.~     Learning how caregivers of children with cancer experience and cope with chronic stress may~     help to develop effective programs for reducing caregiver stress.~   "
64297|NCT02725372|"~     Phase 3, placebo controlled, double-blind, randomized clinical study to determine safety,~     tolerability, and efficacy of pulsed, inhaled nitric oxide (iNO) versus placebo in~     symptomatic subjects with pulmonary arterial hypertension (PAH). Part 1 and Part 2~   "
64298|NCT02725359|"~     Thyroid surgery is a quite painful procedure performed in a sensitive skin area of the human~     body. Unless pain is treated adequately thyroid surgery may cause severe postoperative pain~     and discomfort for the patients.~      a2-Agonists are sympatholytic and centrally acting antihypertensive agents. In addition to~     their hypotensive effect, a2-agonists are also used in anesthetic practice for their sedative~     and analgesic effects. Tizanidine is a centrally acting a2-agonist with muscle relaxant,~     sedative and anxiolytic properties. This drug is widely used for the treatment of spasticity~     and has recently been used to treat musculoskeletal pain conditions.~      Ultrasound (US) guidance during regional anesthesia practices has been a revolutionary~     advancement to improve success and safety of regional anesthesia. Analgesic effect of US~     guidance superficial cervical plexus block (SCPB) in patients undergoing thyroid surgery has~     not been reported yet.~      The aim of this study was to evaluate the analgesic effect of preemptive oral single dose~     tizanidine and US guidance SCPB in patients undergoing elective thyroid surgery. The~     investigators hypothesis that: Tizanidine and US guided SCPB can reduce the pain scores,~     analgesic consumption, analgesic related side effects.~   "
64299|NCT02725346|"~     A computer-assisted solution for acromioplasty is presented. The software allows surgeons to~     better plan the surgical procedure by visualizing dynamic simulation of the patient's~     shoulder joint during everyday activities. Impingements are dynamically detected and the~     exact location and amount of bone to be resected is precisely computed. As a result, the~     success of the acromioplasty does not only rely on the surgeon's experience or previous~     recommendations, but on quantitative data. Although the clinical validation of this 3D~     planning support is currently under evaluation, it may allow to recover more effectively~     postoperative joint mobility, to get a better relationship with pain and a better healing~     rate of the rotator cuff tendons.~   "
64301|NCT02725320|"~     The overall purpose of this work is to use a prospective cohort study to examine~     patient-specific but shoulder-extrinsic factors and how they influence the results of rotator~     cuff surgery. There are undoubtedly many factors that play a role in patient outcome,~     however, this project will focus on three: the effect of gender on outcome, the effect of~     mood disorders and coping style on outcome, and the effect of patient height and reach on~     outcome after rotator cuff surgery. It is hypothesized that these factors will have a~     significant influence over outcomes.~   "
64302|NCT02725307|"~     This study evaluates a novel noninvasive method to dynamically monitor the effect of~     percutaneous transluminal angioplasty on arterial pulse wave~   "
64303|NCT02725294|"~     This observational study will examine the care-seeking behaviors of Veterans with chronic~     obstructive pulmonary disease (COPD) to see whether patients' perceived need for care or lack~     of access to care leads to delays in getting care for COPD exacerbations. Participants will~     complete a baseline in-person visit and receive calls every two weeks for one year to monitor~     for COPD exacerbations. Detailed information about each exacerbation and time to care will be~     obtained. A sample of participants and their caregivers will participate in more in-depth~     interviews. Approximately half the participants will also use a remote inhaler monitor to~     record their albuterol inhaler use to see if this approach can identify early exacerbations.~     Results from this study will be used to develop an intervention that will assist Veterans in~     the early identification, evaluation, and treatment of exacerbations, and will be integrated~     with the VA primary care team.~   "
64304|NCT02725281|"~     Investigators observed that during the Extracorporeal Shock Wave Lithotripsy (ESWL)~     non-pharmacological methods used for reducing the level of the pain and anxiety among the~     patients with the urinary stones are not sufficient and the effectiveness of these methods is~     controversial. There are very few studies, which investigated the effects of music on the~     pain and anxiety during ESWL. In addition, any randomized clinical trial related to the use~     of stress ball for relaxation and distraction on the reduction of pain and anxiety during~     lithotripsy has not been found in the relevant literature. Investigators also evaluated that~     further evidence-based studies are necessary. Thus, investigators aimed to investigate the~     effectiveness of stress ball and music for reducing the pain and anxiety of the patients~     during ESWL in this study.~   "
64305|NCT02725268|"~     The primary purpose of this study is to determine if MLN0128 in combination with weekly~     paclitaxel improves progression-free survival (PFS) compared to weekly paclitaxel alone.~   "
64306|NCT02725255|"~     Intestinal parasites (IP) are among the world's neglected tropical diseases. Morbidity due to~     IPs is greatest in school-age children who typically have the highest burden of infection. In~     2001, WHO passed a resolution for the use of large-scale mass drug administration (MDA) of~     antihelminthic drugs to deworm children in developing countries. Though initially effective,~     there is concern that MDA might not be sustainable over extended periods especially~     considering the large children populations and the high frequency of dosing. Further, the~     MDAs exert increasing drug pressure on parasite populations, a circumstance that is likely to~     favor parasite genotypes that can resist anthelmintic drugs. There is hence a need for~     alternatives that are not only affordable and sustainable but easier to implement in the long~     term with a minimal chance of development of resistance. The investigators propose to develop~     and test the feasibility of a corn porridge meal fortified with papaya fruit extracts that~     have been shown to have antihelminthic properties. The investigators intend to evaluate its~     efficacy when given through school feeding programs and compare the outcome with albendazole-~     the recommended MDA agent for deworming school children. The investigators will design and~     formulate the product and test it among children in three primary schools in Western Kenya.~   "
64307|NCT02725242|"~     This study will evaluate the efficacy of Once-daily Budesonide/formoterol Turbuhaler 160/4.5~     µg/d in the period of step down in well controlled asthmatic patient.~   "
64308|NCT02725229|"~     the objective of the present study was to compare the efficacy of TENS and parasternal block~     with local anesthetic infiltration in relieving pain during the first 24 h period following~     median sternotomy.~   "
64309|NCT02725203|"~     A two-armed, cluster randomized controlled trial will be conducted comparing the Activate~     intervention with care as usual in 31 general practices in the Netherlands, in which~     approximately 279 patients at risk for cardiovascular disease will participate. The Activate~     intervention focuses on increasing physical activity and is developed using the Behavior~     Change Wheel (BCW). The activate intervention consists of four nurse-led consultations~     divided over a 3-months period. Primary outcome is the level of physical activity measured~     with an accelerometer. Potential effect modifiers are age, body mass index, level of~     education, social support, depression, patient-provider relationship and baseline amount of~     minutes of physical activity. Data will be collected at baseline, at 3 months and at 6 months~     of follow up.~      Nurses will be trained in delivering the intervention by a one-day training and coaching~     sessions supervised. A process evaluation will be conducted.~   "
64310|NCT02725190|"~     The purpose of this study is to assess the impact of sleep deprivation on subjective~     inspiratory endurance in healthy subjects.~   "
64311|NCT02725177|"~     Treatment with ACTHAR Gel will result in a reduction of ocular inflammation in patients with~     active ocular sarcoidosis that requires systemic immunosuppressant therapy (hypothesis)~   "
64312|NCT02725164|"~     Fires and operating room pollution may occur when anesthesia gases leak into the oropharynx~     during airway surgery. Investigators sought to measure the concentrations of anesthetic gases~     that leak into the mouth of children undergoing adenotonsillectomy using cuffed and uncuffed~     tracheal tubes during spontaneous and controlled ventilation.~   "
64313|NCT02725151|"~     Known before diagnosed heart failure and used diuretic therapy patients will be admitted in~     this study.The objective of this work is whether the Inferior Vena Cava Ultrasound can be~     used for management of Acute Heart failure therapy. And investigators will calculation~     correlation of extracted urine amount with Inferior Vena Cava diameter change. Researchers~     will not interfere to standard recommended treatment protocol, researchers will correlated~     the urine amount and changed vital signs with therapy with Vena cava inferior diameter.~   "
64314|NCT02725138|"~     We aimed to assess the efficacy of Lactobacillus acidophilus and Lactobacillus rhamnosus in~     the reduction of bacterial load of H. pylori and in the modification of gut microbiotia in~     this double blind, placebo controlled, randomized trial.~   "
64315|NCT02725125|"~     This single-arm, multicenter Phase 2 trial will treat the patients who have relapsed or~     refractory stomach cancer with an infusion of the patient's own T cells that have been~     genetically modified to express a chimeric antigen receptor(CAR) that will bind to tumor~     cells that express the EPCAM protein on the cell surface.The study will determine if these~     modified T cells help the body's immune system eliminate tumor cells.The trial will also~     study the safety of treatment with CAR-T, how long CAR-T cells stay in the patient's body and~     the impact of this treatment on survival.~   "
64316|NCT02725112|"~     This study is a Phase 1, randomized, open label, single dose, 6 treatment, 6 period, 6~     sequence study in healthy adult volunteers. A total of 24 (4 in each treatment sequence)~     healthy male and female subjects who, at the time of screening, are between the ages of 18~     and 55 years, inclusive will be enrolled. Subjects who discontinue from the study may be~     replaced at the Sponsor's discretion. Screening activities will be completed within~     approximately 28 days prior to Day 1 of Period 1. Subjects will be randomized to 1 of the 6~     treatment sequences as described in Table 1 below. Each treatment sequence will consist of 6~     periods with subjects receiving single doses of pregabalin ER 330 mg target release rate~     tablet, pregabalin ER 330 mg slow release rate tablet, pregabalin ER 330 mg fast release rate~     tablet, pregabalin IR 300 mg capsule, pregabalin ER 82.5 mg target release rate tablet, and~     pregabalin ER 330 mg aberrant fast release rate tablet formulations. All study treatments~     will be administered following a 600- 750 calorie, 30% fat evening meal.~   "
64317|NCT02725099|"~     To examine chewing versus traditional oral administration of ticagrelor in ST-elevation~     Myocardial Infarction (STEMI) patients on platelet reactivity.~   "
64318|NCT02725086|"~     A Randomized, Open-label, Two-way Crossover, Open-label Clinical Trial to Compare~     Pharmacokinetic/Pharmacodynamic Properties and Safety after Subcutaneous Administration of~     Leucostim® and Neupogen® in Healthy Adult Volunteers~   "
64319|NCT02725073|"~     To determine the safety and efficacy of photodynamic therapy with a novel photosensitizer and~     a flexible laser probe in locally advanced hilar cholangiocarcinoma.~   "
64320|NCT02725060|"~     The purpose of this study is to see if some people with postural tachycardia syndrome (POTS)~     have higher levels of immune proteins (autoantibodies) directed against receptors of the~     autonomic nervous system, and if these autoantibodies make a difference in their POTS~     symptoms. The investigators also want to see if the levels of these autoantibodies stay the~     same over time.~   "
64321|NCT02725047|"~     The purpose of this study is to verify the effect of cryotherapy in pain control, function~     and quality of life in individuals with knee osteoarthritis.~   "
64322|NCT02725034|"~     The purpose of this study is to assess whether high definition endoscopy with Optic~     Enhancement can reduce the biopsy number needed per patient for the detection of gastric~     intestinal metaplasia without the loss of corresponding diagnostic yield~   "
64323|NCT02725021|"~     A two armed randomized trial is evaluating the effect of the medical-student-delivered~     school-based intervention Education Against Tobacco on the smoking behavior of adolescents in~     7-11th grade of secondary school. The primary endpoint is the change in smoking prevalence~     between the two groups.~   "
64324|NCT02725008|"~     Comparing one versus two doses of oral dexamethasone for the treatment of asthma in the~     pediatric emergency department.~   "
64325|NCT02724995|"~     This study will help the investigator understand the pathogenesis of different rare genetic~     conditions and to establish database of rare genetic databases. This would ultimately help to~     provide more accurate diagnosis through advanced genomic diagnostic testing and databases~     established from this study. This knowledge would in turn help in the clinical management of~     other affected family members and other individuals affected with similar conditions.~     Understanding of pathogenesis of the disease would also enable the investigator to develop~     targeted therapies for rare genetic diseases, and also to collaborate on the targeted~     therapy-related clinical trials.~      The investigator plans to store the results of this study in databases. These results will be~     shared with other researchers or doctors, who research, diagnose or treat the individuals~     with similar diseases.~      The investigator will only share the data that is collected and not the biological samples.~   "
64326|NCT02724982|"~     Body image satisfaction and self- esteem level are important to be known among students in~     order to intervene in a correct time. Body dissatisfaction is one of the factors leading to~     negative self-perception, low mood, depression, and eating disorders. This may be detrimental~     to students in their academic performance. However, the correlations of body image~     satisfaction towards body mass index and self- esteem among university female students are~     still unclear in Malaysia. Thus, the purpose of this study is to determine its relationships~     among Chinese female students. university female participants will be included with~     convenience sampling method. Participants will completed Ronsenberg Self- Esteem Scale and 8~     items version of Body Shape Questionnaire. These 2 scales used to measure level of self-~     esteem and body image satisfaction. Body mass index will be calculated from self- reported~     height and weight. The data will be analysed by using descriptive and correlation methods.~   "
64327|NCT02724969|"~     The purpose of this pilot randomized trial is to determine the effectiveness, feasibility,~     and acceptability of a mobile, semi-automated text message-based intervention (MILK) to~     prevent perceived low or insufficient milk supply (PIM) among mothers without prior~     breastfeeding experience. PIM is the leading cause of premature breastfeeding cessation, and~     prior work shows that it is often rooted in low breastfeeding self-efficacy and~     misconceptions about lactation physiology and trajectory. The MILK intervention is designed~     to address PIM, as well as other common breastfeeding problems via semi-automated text~     messages of prenatal and postpartum breastfeeding education and support. Messages are~     time-sensitive (e.g., specific to gestational age, time since delivery) and based on the~     Breastfeeding Self-Efficacy (Social Cognitive) Theory; they are also modeled from pilot work~     that investigated how first-time mothers view, manage and describe breastfeeding problems.~     Messages were vetted with clinical lactation experts, as well as pregnant and postpartum~     women with no other children.~      The MILK intervention will be trialed against a control intervention group, who will receive~     general perinatal education through the national Text4Baby system. The investigators will~     recruit approximately 186 healthy, pregnant women at 13-25 weeks gestation from Magee Women's~     Hospital clinics and outpatient sites. Women will be randomized via computer-generated simple~     randomization to the experimental or control intervention. Both groups will receive text~     messages 3-5 times per week from week 25 of pregnancy through week 8 postpartum. Measured~     outcomes of interest will include perceived breast milk supply, breastfeeding confidence,~     maternal anxiety, breastfeeding exclusivity, and breastfeeding duration. Data will be~     collected at baseline (13-25 gestational weeks), 34-36 gestational weeks, and at 1, 2, 4, and~     8 weeks postpartum via online survey or telephone call. To assess the potential longer-term~     impact of the intervention, breastfeeding continuation and exclusivity will be reassessed via~     telephone at 6 months postpartum. Between group and group x time differences in outcome~     measures will be examined graphically and via linear mixed modeling. To inform modifications~     to MILK, telephone interviews will be conducted with a subset of participants in each group~     to assess and compare intervention use, burdens and challenges, and suggested alterations (8~     weeks).~   "
64328|NCT02724956|"~     Participant is being asked to take part in this study because participant is going to have~     surgery that requires general anesthesia (in which participant is unconscious for the~     procedure).~      During surgery, anesthesiologists often place a supraglottic airway device (SGAD). An SGAD is~     a device that helps participant breathe and may help the anesthesiologist put a breathing~     tube in participant's airway while participant is asleep during surgery. There are many~     different kinds of SGADs that are readily available for use by anesthesiologists during~     surgery. The SGADs that are being studied are the Ambu Auragain and the Teleflex LMA~     Protector.~      The goal of this clinical research study is to compare the effectiveness of both devices.~      This is an investigational study. Both of the SGADs that are being used on this study are FDA~     approved and are frequently used for the surgery that participant is going to have. It is~     investigational to compare the 2 devices.~      Up to 50 participants will be enrolled in this study. All will take part at MD Anderson.~   "
64329|NCT02724943|"~     A systems approach emphasizes the linkage between individual behavior change strategies and~     social and physical environmental changes, which act synergistically to facilitate (or~     inhibit) healthy eating and active living. The hypothesis of this study is that among~     low-income, ethnically diverse overweight and obese children, aged 2-12 years, a systems~     approach to child obesity will reduce body mass index (BMI) compared to primary prevention~     alone.~   "
64330|NCT02724930|"~     This study will test the effectiveness of using enhanced facilitation strategies on~     implementation of an automated Interactive Voice Response (IVR) system as a means to remotely~     deliver in-home self-management support to Veterans with chronic pain. The implementation~     intervention uses an enhanced facilitation approach paired with automated case finding and~     direct patient outreach to encourage uptake of Cooperative Pain Education and Self-management~     (COPES). A nested effectiveness study will measure pre-post differences in pain-relevant~     outcomes (pain intensity, physical functioning and physical activity). The investigators will~     use a stepped wedge cluster design in which clusters will be randomized to the timing of the~     introduction of enhanced COPES implementation. Investigators will assess the efficacy of the~     facilitation based implementation strategy by evaluating COPES uptake in the implementation~     settings.~   "
64331|NCT02724917|"~     The purpose of this study in patients with schizophrenia is to evaluate the safety,~     tolerability, and pharmacokinetics of 3 doses (low, mid, high) of APN1125 compared with~     placebo when administered as repeated daily oral doses.~   "
64332|NCT02724904|"~     This research study is assessing the feasibility of reduced intensity allogeneic~     hematopoietic stem cell transplantation (HSCT) as a possible treatment for relapsed /~     refractory non-Hodgkin lymphoma involving the central nervous system (CNS). HSCT is the~     transplantation of stem cells, usually derived from bone marrow, peripheral blood, or~     umbilical cord blood.~   "
64333|NCT02724891|"~     Patient-reported outcomes are commonly used in healthcare. Examples include validated~     symptom-based questionnaires and health diaries. In the field of Female Pelvic Medicine and~     Reconstructive Surgery there are many questionnaires and diaries that have been validated for~     a paper-based administration. As technology is incorporated into delivery of medical care and~     research, investigators need to consider how to collect data electronically while ensuring~     that this new format is equivalent to the paper questionnaires they rely on. In this study,~     the investigators aim to validate a series of validated questionnaires and symptom diaries~     administered via the web and smartphone for a more streamlined care for the patients.~   "
64334|NCT02724878|"~     This research study is studying the combination of Atezolizumab and Bevacizumab as a possible~     treatment for Advanced Non-Clear Cell Kidney Cancer.~   "
64335|NCT02724865|"~     Obstructive sleep apnea (OSA) is a common chronic sleep disorder that often requires lifelong~     care. The prevalence in the Netherlands is estimated around 300.000 patients. Due to longer~     life expectancy and increase in weight in the general population, its prevalence is expected~     to rise. Patients with mild and moderate OSA are treated primarily with an oral appliance at~     present time. Different oral appliances are available, but most used is the mandibular~     advancement device (MAD). This study focuses on two different types of MAD: the classic~     Herbst appliance, which is attached to the mandible and the maxilla and has an iron bar to~     regulate the open space; and the Somnodent, which consists of two separate splints, fixed on~     the mandible and the maxilla, but has no iron bar attached.~   "
64336|NCT02724852|"~     This is a prevalence study of protective antibodies to measles, mumps, and rubella (MMR) in~     HIV-infected adults and HIV-uninfected controls. MMR vaccination were provided to both groups~     who had no protective antibodies to at least one of the three viruses.~   "
64337|NCT02724839|"~     The purpose of this study is to design, pilot, and tweak a series of peer-led group nutrition~     sessions for primary care patients aged 6 -12 years who are overweight or obese and who want~     to eat healthier and be more active.~   "
64338|NCT02724826|"~     A randomized controlled, multicenter trial comparing qigong and exercise therapy concerning~     pain intensity, treatment expectations, disability, neck movements and quality of life in~     subjects with non-specific, long-term NP after three and twelve months.~   "
64339|NCT02724813|"~     Stroke results in long-term disability for many people, and particularly for survivors of~     stroke who have cognitive impairments. However, a decreasing proportion of stroke patients~     are able to access or receive publicly funded rehabilitation. The investigators have shown in~     previous studies that in-person delivery of the Cognitive Orientation to daily Occupational~     Performance (CO-OP) rehabilitation approach to promoting attainment of everyday life goals~     has resulted in improvements in functional independence and executive function. In a small~     pilot study of tele-CO-OP with people with chronic traumatic brain injury (TBI) (n=3), the~     investigators found the delivery method was feasible and that participants were satisfied~     with the treatment and demonstrated clinically significant improvements on personally~     meaningful activities. The investigators will investigate the feasibility, preliminary~     efficacy, and cost-effectiveness of delivering CO-OP in an online format to reduce disability~     post-stroke. The study design is a single-blind (assessor), randomized wait-list control~     trial with a one-month retention follow-up. All therapy and testing sessions will be~     delivered online. We hypothesize that participants will demonstrate improvement in everyday~     activities and community participation.~   "
76215|NCT02569385|"~     The aim of the present study is to determine the cardiovascular function/ cardio respiratory~     interaction on spontaneous breathing trials in patients with prolonged weaning.~   "
64341|NCT02724787|"~     Impulsive aggression (IA) is common among Veterans with posttraumatic stress disorder (PTSD),~     and PTSD is one of the most prevalent post deployment mental health conditions affecting~     Afghanistan and Iraq Veterans. An inability to manage one's emotions (emotion dysregulation)~     is an underlying mechanism of IA. Reducing IA and increasing use of PTSD evidence-based~     psychotherapies are two critical missions for the Veterans Health Administration.~      This research supports these missions by providing a 3-session emotion regulation training~     (Manage Emotions to Reduce Aggression) to Veterans in order to teach them how to manage~     emotions and prepare for PTSD treatment. This is an open trail, so all Veterans who meet the~     inclusion criteria will be allowed to receive the treatment. Each Veteran's level of~     aggression and emotion dysregulation will be measured at the beginning and end to the~     treatment. By enhancing Veterans' abilities to cope with trauma-related emotions and feel~     equipped to initiate PTSD treatments, this research aims to help Veterans decrease IA and~     ultimately recover from PTSD.~   "
64342|NCT02724774|"~     Treating mothers' perinatal depressive and other mental health symptoms alone does not~     prevent impaired parenting quality and adverse infant outcomes. The goal of this research is~     to conduct a randomized controlled trial to evaluate the effectiveness of adding a~     research-based 10-week home visiting parenting program to evidence-based mental health~     treatment, to counter the pernicious effects of mothers' symptoms on parenting quality and~     infant development. Participants will be English and Spanish-speaking low-income mothers who~     began publicly funded mental/behavioral health treatment in pregnancy at their primary care~     community health centers.~   "
64343|NCT02724761|"~     Our double-blinded, randomized control trial will assess the effect of nebulized racemic~     epinephrine inpatients undergoing anterior cervical discectomy and fusion (ACDF) procedures.~     The investigators have had success in managing post-operative dysphagia in patients~     undergoing ACDF with the administration of this drug. Half of the participants will review~     nebulized epinephrine. The other half will receive placebo.~   "
64344|NCT02724748|"~     To compare the effects of an educational intervention to usual practice (no specified staff~     education) on improving treatment culture and supporting team climate in staff members, which~     further could reduce the need for the use of coercive methods in psychiatric care.~   "
64345|NCT02724735|"~     All subjects completing the randomized treatment period in Protocol NS2014-1 will discontinue~     study drug and be asked to provide consent to be followed in this 6-month study, at their~     final safety visit. The study will consist of an enrollment visit, followed by bi-monthly~     in-clinic visits with monthly telephone visits between in-clinic visits.~   "
64346|NCT02724722|"~     Melamine and phthalates are environmental emerging chemicals, which are ubiquitously present~     in the public and easily contacted by children through air, foods, and skin. This study aims~     to examine whether the use of family-based behavior intervention by providing simple flyers~     plus face-to-face health education point-by-point and give one bag containing stainless~     steel-made tableware for eating out use to study children's mothers or main-care givers can~     significantly decrease melamine and phthalates exposure by measuring urinary melamine and~     metabolites of phthalates (especially DEHP metabolites) in study children and their mothers~     or main-care givers, when compared to those provided simple flyers only.~   "
64347|NCT02724709|"~     The progress in surgery of the aortic root and the evolution of transcatheter aortic valve~     replacement as an alternative to surgical treatment in selected patients have refocused the~     need for quantitative imaging of the aortic root during transcatheter aortic valve~     replacement and valve-sparing aortic root surgery. In this study, we aim to assess the~     ability of semi-automated quantitative modeling (eSie Valves, Autovalve prototype version,~     Siemens Medical Solutions, USA) of the aortic valve and root in patients with clinical normal~     aortic valve and root, who are indicated for both 3D transesophageal echocardiography (TEE)~     and computed tomographic (CT) due to atrial fibrillation or patent foramen ovale. Measures of~     the aortic valve and root obtained by 2D TEE, 3D TEE and CT are compared, and the ability of~     the semi-automated 3D TEE modeling software is tested. Given the workflow advantages of~     automation, this 3D TEE approach may enhance the clinical adoption of routine 3-dimensional~     imaging beyond CT.~   "
64348|NCT02724696|"~     RYTHMIC (Réseau tumeurs THYMiques et Cancer) is a French nationwide network for TET with the~     objective of territorial coverage by regional expert centers and systematic discussion of~     patients management at national tumor board.~   "
64349|NCT02724683|"~     The purpose of this study is to determine whether drainage with the usage of a fine,~     patient-controlled vascular catheter inserted into abdominal cavity is a feasible, safe and~     effective method in the management of symptomatic malignant ascites. Complications' rate of~     the procedure and patients' quality of life, nutritional status and experience on the~     treatment are main endpoints.~   "
64350|NCT02724670|"~     MR (Magnetic Resonance Imaging) - based IGRT (image-guided radiotherapy) for patients with~     prostate carcinoma.~   "
64351|NCT02724657|"~     To assess the effectiveness of the Buteyko method as an adjunct therapy in the treatment of~     asthmatic children with mouth breathing.~   "
64352|NCT02724644|"~     The study will evaluate the safety, effectiveness, and immunogenicity of EN3835 in the~     treatment of adult women with Edematous Fibrosclerotic Panniculopathy (Commonly known as~     Cellulite).~   "
64353|NCT02724631|"~     This is the first of three planned phases designed to evaluate the feasibility and~     tolerability of TubeClear® to restore patency in occluded Pediatric Enteral Access Devices.~     Based on preliminary data obtained from this phase of the study, subsequent phases will~     continue to evaluate feasibility and tolerability (Phase IIA) and ultimately compare efficacy~     of TubeClear® to the Children's Hospital of Philadelphia (CHOP) Standard Treatment to restore~     patency in occluded Pediatric Enteral Access Devices (EAD) (Phase IIB).~   "
64354|NCT02724618|"~     There is a growing body of evidence exploring the role of curcumin as a radioprotector~     against radiation-induced injury in normal tissues as well as a radiosensitizer in tumor~     cells. The aim of this study is to determine the efficacy of oral nanocurcumin in prostate~     cancer patients undergoing radiotherapy.~   "
64355|NCT02724605|"~     The aim of the study is to detect if the storage duration of red blood cells has impact on~     some biochemical parameters after intra operative transfusion in pediatric trauma patient~   "
77785|NCT02548858|"~     The purpose of this study is to determine whether performing a perineorrhaphy during a~     reconstructive surgery indicated for pelvic organ prolapse (POP) affects a patient's body~     image.~   "
64356|NCT02724592|"~     Objectives: Occlusal surfaces of erupting permanent molars are highly prone to caries.~     Self-assembling peptide (P11-4) has proven to enhance biomimetic mineralization of early~     carious lesions. Aim of this study was to evaluate safety, clinical applicability and effect~     of using P11-4 (Curodont™ Repair) in non-invasive treatment of early occlusal lesions.~      Methods: 70 patients with active early occlusal lesions (ICDAS-II:1-3) on first or second~     permanent molars at eruption will be allocated in this randomized, controlled, single blinded~     study to test (Curodont™ Repair+Duraphat®) or control (Duraphat®) groups.~   "
64357|NCT02724579|"~     This phase II trial studies how well reduced doses of radiation therapy to the brain and~     spine (craniospinal) and chemotherapy work in treating patients with newly diagnosed type of~     brain tumor called WNT)/Wingless (WNT)-driven medulloblastoma. Recent studies using~     chemotherapy and radiation therapy have been shown to be effective in treating patients with~     WNT-driven medulloblastoma. However, there is a concern about the late side effects of~     treatment, such as learning difficulties, lower amounts of hormones, or other problems in~     performing daily activities. Radiotherapy uses high-energy radiation from x-rays to kill~     cancer cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, vincristine~     sulfate, cyclophosphamide and lomustine, work in different ways to stop the growth of tumor~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Giving reduced craniospinal radiation therapy and chemotherapy may kill tumor~     cells and may also reduce the late side effects of treatment.~   "
64358|NCT02724566|"~     Preclinical studies have demonstrated in mouse models that (PYR1)-apelin-13 exerts a~     glucose-regulating action in vivo. The (PYR1)-apelin-13 effect on insulin sensitivity in~     healthy overweighed volunteers has been previously assessed in a phase I clinical trial~     (APELINS study; NCT02033473). The APELINS-2 clinical trial aims to expand the initial proof~     of concept to the population targeted by future innovative insulin-sensitizing therapies:~     patients living with type 2 diabetes.~   "
64359|NCT02724553|"~     Previous studies attempted to understand the dysphotopsia phenomenon by examining intraocular~     lens type, anterior capsule depth, iris-to-lens depth, lens refractive material, clear cornea~     incision wounds and anterior capsulorrhexis. However, there is limited literature in~     understanding haptic orientation and negative dysphotopsia; postulated theories and anecdotal~     reports relate to horizontal haptic orientation and the lateralization of rays such that~     light is received both in smaller width and anterior to the peripheral retina; however, no~     formal studies currently exist.~   "
64360|NCT02724540|"~     The primary aim of this trial is to estimate the duration of hepatic progression-free~     survival (HPFS) in participants treated with bland embolization (BE), transcatheter arterial~     Lipiodol chemoembolization (TACE), and embolization by drug-eluting beads (DEB). The primary~     hypothesis is that chemoembolization will be nearly twice as durable as bland embolization;~     thatis, the hazard ratio for HPFS will be 1.76 or better.~   "
64361|NCT02724527|"~     Cavosonstat (N91115) is being studied as a potential novel therapy for cystic fibrosis (CF),~     and this study assesses a target population of patients who are heterozygous for F508del-CFTR~     and a gating mutation that is approved for treatment with ivacaftor (G551D, G1244E, G1349D,~     G178R, G551S, S1251N, S1255P, S549N, or S549R).~   "
64362|NCT02724514|"~     Breast lymphedema (swelling due to fluid) is a common complication of breast cancer therapy.~     Unlike lymphedema in the arm, breast lymphedema is not as well-known and has not been~     studied. At present, no objective and standardized tools exist to evaluate breast lymphedema.~      The purpose of this study is to investigate the use of ultrasound analysis and bio-impedance~     to determine if it is possible to measure the extent of the fluid in the breast.~   "
64363|NCT02724501|"~     This project seeks to understand the role of the PTEN tumour suppressor gene in endometrial~     cancer (tumours of the uterine lining), the most common gynecologic cancer in the developed~     world. The studies in this program span the spectrum from fruit flies to humans, as part of a~     synergistic partnership that will significantly enhance our understanding of the molecular~     genetic events involved in the development and progression of endometrial cancer. The~     discovery of new targets for therapy, and the ability to evaluate these in subsequent~     clinical trials is a significant strength of this scientific interaction, which may result in~     cures for patients with primary and relapse endometrial cancer and prevention of this cancer~     in women who are at high risk.~   "
64364|NCT02724488|"~     Two part prospective study to:~        1. investigate the feasibility of performing ultra-deep sequencing of plasma derived~          circulating tumor DNA (ctDNA) in individual patients with advanced solid tumors who are~          currently being treated with immune checkpoint inhibitors (ICIs) and~        2. obtain fresh tumor biopsies and serial blood samples to investigate the clonal evolution~          of tumors under the selection pressure of ICIs.~   "
64365|NCT02724475|"~     Hepatocellular carcinoma (HCC) is the fifth most-common cancer worldwide and the second~     most-common cause of cancer mortality. Liver resection is the first-line curative treatment~     for huge HCC. The 5-year overall survival (OS) rates after hepatic resection were range from~     25% to 45% and the incidence of portal vein tumor thrombus (PVTT) for intermediate and~     advanced hepatocellular carcinoma patients were as high as 60%-90%. At present, there is no~     effective treatment for patients with PVTT. Laser ablation (LA) showed a good performance in~     eliminating the PVTT and the three-dimensional conformal radiotherapy (3D-CRT) with γ Ray~     (γ-knife) can also be used to treat patients with PVTT. But there still lack of~     evidence-based research to compare the clinical outcome of 3D-CRT with γ Ray and LA. In view~     of this, we aim to implement a randomized controlled study to find out an effective treatment~     for intermediate and advanced hepatocellular carcinoma patients with PVTT based on~     evidence-based research.~   "
64366|NCT02724462|"~     The goal of this study is to determine whether the novel smartphone app (SmartQuit) provides~     higher quit rates than the current standard smoking cessation app.~   "
64367|NCT02724449|"~     The purpose of this study is to obtain information concerning the safety and effective use of~     a protective barrier film in patients experiencing severe incontinence associated dermatitis.~   "
64454|NCT02723318|"~     The investigators have partnered with financial coaching organizations to establish what the~     investigators have termed a Medical-Financial Partnership (MFP) that offers financial~     coaching to improve financial and mental health. The investigators will evaluate the MFP's~     impact on cognition using the Patient Reported Outcomes Measurement Information System~     (PROMIS) Cognition Short form 8a.~   "
64368|NCT02724436|"~     Hepatocellular carcinoma (HCC) is the fifth most-common cancer worldwide and the second~     most-common cause of cancer mortality. Liver resection is the first-line curative treatment~     for huge HCC. The 5-year overall survival (OS) rates after hepatic resection were range from~     25% to 45%. Transarterial chemoembolization (TACE) is the major treatment option for the~     unresectable primary or secondary liver malignancies. Yittrium-90 (Y-90) is a pure~     beta-emitter, without any toxic effect or immune rejection. There are ample data that support~     the use of Y-90 microspheres for primary and metastatic liver tumors. The aim of our study~     was to compare the clinical outcome of radioembolization with Y-90 and TACE and provide a new~     strategy for the treatment of intermediate and advanced hepatocellular carcinoma with portal~     vein thrombus by conduting a randomized trial.~   "
64369|NCT02724423|"~     This study evaluates the pharmacokinetic and safety of NRL-1 in epilepsy subjects. Subjects~     will receive a single intranasal dose of NRL-1 of either 5 mg, 10 mg, 15 mg or 20 mg and will~     be based on the subject's body weight.~   "
64370|NCT02724410|"~     To compare the effect of a single-agent home intravenous (IV) versus oral antibiotic therapy~     on complication rates and resource utilization following appendectomy for perforated~     appendicitis~   "
64371|NCT02724397|"~     Linked color imaging (LCI) and magnifying blue laser imaging (BLI) are two new imaging~     systems used in endoscopy which are recently developed. BLI was developed to compensate for~     the limitations of NBI. BLI shows a bright image of the digestive mucosa, enabling the~     detailed visualization of both the microstructure and microvasculature. However, BLI still is~     not able to obtain sufficient brightness for distant lesions. The newly developed LCI system~     (FUJIFILM Co.) creates clear and bright endoscopic images by using short-wavelength~     narrow-band laser light combined with white laser light on the basis of BLI technology. LCI~     makes red areas appear redder and white areas appear whiter. Thus, it is easier to recognize~     a slight difference in color of the mucosa. This is a study to determine if using LCI of the~     colon, rather than the usual white light on the colon, will improve the detection of flat~     adenomas and serrated polyps. The polyps are called serrated because of their appearance~     under the microscope after they have been removed. They tend to be located up high in the~     colon, far away from the rectum. They have been definitely shown to be a type of precancerous~     polyp and it is possible that using LCI will make it easier to see them, as they can be quite~     difficult to see with standard white light. LCI/BLI enables endoscopists to accurately~     describe the pit pattern of adenomas. By comparing White Light Endoscopy and LCI/BLI, it will~     show if there is any comparable advantage to using one or the other for lesion detection and~     assessment.~   "
64372|NCT02724384|"~     The purpose of this study is to evaluate the safety and preliminary efficacy of using~     electrical plasma to treat toenail fungus.~   "
64373|NCT02724371|"~     The study will evaluate the safety and effectiveness with the Mentor MemoryGel® Larger Size~     Ultra High Profile (UHP-L) Breast Implants.~   "
64374|NCT02724358|"~     In order to provide a new option for clinical anti-angiogenesis therapy in hepatoma, a~     randomized controlled study is planed to confirm the effect of Rg3 in combination with TACE~     on angiogenesis and tumor treatment in advanced hepatocellular carcinoma patients with high~     expression of Notch1.~   "
64375|NCT02724345|"~     To evaluate and analyse the clinical effect and application value of postoperative adjuvant~     TACE treatment in patients with different expression levels of CK18 using randomized~     controlled study and provide evidence for the necessity of postoperative adjuvant TACE.~   "
64376|NCT02724332|"~     To evaluate the clinical effect of rapamycin combined with TACE on early-stage HCC with~     overexpression of ASPH after radical surgery using randomized controlled study and provide a~     new anti-recurrence treatment for HCC patients after operation.~   "
64377|NCT02724319|"~     It is well established that clopidogrel-induced antiplatelet effects is suboptimal in many~     patients who are thus exposed to an increased risk of adverse cardiovascular events. Studies~     have shown that genotypes of the cytochrome P450 (CYP) 2C19 enzyme, which is a key~     determinant of clopidogrel metabolism, contribute to these findings. Prasugrel and ticagrelor~     are alternative agents whose effectiveness is not dependent on CYP2C19 genotype. A boxed~     warning on the Food and Drug Administration (FDA)-approved clopidogrel labeling warns of~     reduced effectiveness in patients with the LOF genotype and recommends alternative therapies~     in these patients. The availability of an assay recently approved by the FDA, SpartanRX,~     which provides results within one-hour facilitates performing genetic testing as a clinical~     test in real-world practice. We therefore propose to 1) examine the feasibility of~     implementing CYP2C19 genotyping using SpartanRX as standard of care for patients undergoing~     cardiac catheterization at UF Health Jacksonville providing the opportunity for clinicians to~     embrace genotype-guided antiplatelet therapy in those who proceed to PCI and 2) determine if~     CYP2C19 genotype-guided antiplatelet therapy reduces the risk for major adverse~     cardiovascular outcomes after PCI.~   "
64378|NCT02724306|"~     The present study will use a randomised controlled trial design to investigate whether~     moderate to vigorous intensity physical activity (MVPA) will affect the physiological risk~     markers associated with the development of bowel cancer in individuals previously diagnosed~     with a bowel polyp. The study will also investigate the effects of the programme on long-term~     exercise behaviour and changes in psychological variables. A selected sample will also be~     part of individual interviews at baseline and 12 months to gauge narrative accounts of~     personal, psychological and sociological beliefs surrounding participation in physical~     activity. The findings of this study might inform better practices for the prevention of~     bowel cancer in high risk populations.~      After a screening colonoscopy, eligible participants will be randomised to either an active~     lifestyle programme (ALP) or a standard care group (SC). Participants in ALP will be offered~     supervised exercise sessions and motivational interviewing for 6 months. Intervention~     components will cease after 6 months, but participants will be followed-up at 12 months to~     investigate maintenance to physical activity over the long-term. The SC will not be offered~     the intervention until the end of the study. Participants in both groups will be invited for~     assessments at baseline, 3, 6, 9, and 12 months. These include measurements of body~     composition, cardiopulmonary fitness, physical activity behaviour, and psycho-social~     variables.~   "
64379|NCT02724293|"~     This study compares analgesic efficacy, and safety of three different doses of peri-operative~     pregabaline to placebo following radical cystectomy.~   "
64380|NCT02724280|"~     H. pylori infection plays a very important role in gastric carcinogenesis, progressing from~     chronic gastritis through atrophic gastritis, intestinal metaplasia, dysplasia and finally~     cancer. It is difficult to diagnose H. pylori related gastritis and gastric atrophy on the~     basis of endoscopic findings. Histology is currently considered to be the gold standard for~     detecting H. pylori infection. The reliability of detecting H. pylori infection~     histologically depends on the site, number, and size of gastric biopsy specimens. The blind~     biopsy sampling of normal appearing mucosa has the risk of missing pathology and sampling~     errors. Most studies conclude that as well as on expertise in staining and visualizing the~     bacteria. Considerable error also occurs in identifying gastric atrophy using blind biopsy~     sampling, and neither the original nor the revised version of the Sydney system reliably~     identifies more than half the cases in patients with confirmed gastric atrophy.~   "
64381|NCT02724267|"~     The aim of this study is to evaluate the 131I-chTNT-1/B treatment effect and safety of~     individual therapy using randomized controlled study, in order to acquire the evidence of~     evidence-based medicine and create a new program of targeted internal radiation therapy in~     advanced HCC patients.~   "
64382|NCT02724254|"~     This is a double-blind placebo controlled, randomized, phase 2 study to assess the safety,~     tolerability, pharmacokinetics and efficacy of twice daily topical applications of AP611074~     5% Gel for up to 16 weeks in condyloma patients~   "
64383|NCT02724241|"~     Randomized controlled trial of electronic cigarettes with nicotine, without nicotine, and~     sham control, on sympathetic nerve activity and markers of oxidative stress.~   "
64384|NCT02724228|"~     This is a Phase 2, Open-Label, Extension Study to Evaluate the Long-Term Safety,~     Tolerability, and Efficacy of BMN 111 in Children with Achondroplasia. The primary objective~     is to evaluate the long-term safety and tolerability of daily SC injections of BMN 111 in~     children with ACH who have completed two years of treatment in the 111-202 study.~   "
64385|NCT02724215|"~     In this observational study patients with subarachnoid hemorrhage (SAH) will be screened for~     sleep apnea (SA) to investigate if SA is associated with impaired blood pressure control and~     worse clinical outcome early after SAH.~   "
64386|NCT02724202|"~     The purpose of this study is to test the safety and find the response rate of combining the~     dietary supplement, curcumin, with the standard of care, FDA-approved chemotherapy drug~     5-fluorouracil (5FU, Adracil) and see what effects (good and bad) that the combined~     treatments have on colon cancer.~   "
64387|NCT02724189|"~     This pilot study will intend to assess the feasibility and acceptability of MyPreOp (online~     pre-operative assessment tool). The study will aim to assess the quality of the MyPreOp~     assessment in comparison to standard practice of a nurse led face to face assessment. The~     investigators will also assess the acceptability of MyPreOp amongst patient participants and~     staff participants.~   "
64388|NCT02724176|"~     Papillary thyroid cancer (PTC) is the most common subtype of thyroid cancer.~      The most common site of PTC nodal metastases is the central neck, which has a reported rate~     of lymph node metastases as high as 50%~70%.~      Central neck dissection has important value to ensure accurate clinical staging and surgical~     planning.~      As a novel lymphatic tracer, carbon nanoparticles (CN) have been applied successfully in the~     detection of sentinel lymph nodes in breast and gastric cancers, while not been used as a~     lymphatic tracer for PTC. The goal of this study was to evaluate whether the use of CN~     facilitates the detection of lymph nodes, increases the number of metastatic lymph nodes~     removed, accurately reflects the metastatic condition of the central neck, and has the~     potential to protect the parathyroid glands.~   "
64389|NCT02724163|"~     The main purpose of this study is :~        1. To establish which number of doses of gemtuzumab ozogamicin (up to a maximum of 3 doses)~          is tolerated and can be safety delivered in combination with cytarabine plus~          mitoxantrone or liposomal daunorubicin in induction~        2. To compare mitoxantrone (anthracenedione) & cytarabine with liposomal daunorubicin~          (anthracycline) & cytarabine as induction therapy.~        3. To compare a single dose of gemtuzumab ozogamicin with the optimum tolerated number of~          doses of gemtuzumab ozogamicin (identified by the dose-finding study) when combined with~          induction chemotherapy.~        4. To compare two consolidation regimens: high dose cytarabine (HD Ara-C) and fludarabine &~          cytarabine (FLA) in standard risk patients.~        5. To compare the toxicity and effectiveness of two haemopoietic stem cell transplant~          (HSCT) conditioning regimens of different intensity: conventional myeloablative~          conditioning (MAC) with busulfan/cyclophosphamide and reduced intensity conditioning~          (RIC) with fludarabine/busulfan.~   "
64390|NCT02724150|"~     Evaluate the efficacy of Two different regimens of proton pump inhibitors High against Low in~     the management of acute peptic ulcer bleeding~   "
64391|NCT02724137|"~     The purpose of this study is to:~        1. Determine whether the Physical Therapy (PT) & Fitbit® intervention should proceed to a~          full-scale clinical trial. This decision will be based on three hypotheses: Treatment~          promise (Hypothesis 1A): People in the PT & Fitbit® will walk 1250 more steps/day and~          spend 7 min/day more in moderate to vigorous physical activity (MVPA) than the control~          at discharge and at 6 months and 12 months, Safety (Hypothesis 1B): < 5% will have~          adverse events because of the intervention, A research assistant will collect data on~          adverse events that occur from the time of randomization until the last follow-up visit~          3 months after discharge from PT. An adverse event is any unfavorable or unintended~          diagnosis, sign, symptom, or disease temporarily associated with the study intervention,~          which may or may not be related to the intervention. Adverse events include any new~          events not present during the pre-intervention period or events that were present during~          the pre-intervention period which have increased in severity. Major adverse events, such~          as infection, re-hospitalization or development of new comorbidities will also be noted.~          Recruitment (Hypothesis 1C): 75 recruited, 90% to complete trial, and 85% complete visit~          at 6 months and 12 months.~        2. To evaluate the short- and long-term adherence of the PT & Fitbit® intervention.~          Short-term Adherence (Hypothesis 2A): 90% of subjects in the PT& Fitbit® group will wear~          the Fitbit® and participate in goal setting and behavioral counseling while in PT.~          Long-term Adherence (Hypothesis 2B): 75% of PT & Fitbit® will wear the Fitbit® at 6~          months and 12 months.~        3. To quantify changes in potential underlying mechanisms for increased physical activity.~          (Hypothesis 3): Change in self-efficacy for physical activity, walking endurance and~          participation in daily activities will be associated with improvements in physical~          activity.~        4. To assess intervention fidelity (Hypothesis 4): (4a) using the electronic medical~          record, the treating PT will check off that they 1) reviewed physical activity recorded~          by the Fitbit® and 2) discussed step goals for all study subjects randomized to the~          intervention group. (4b) treating PTs will be asked to audio record five-intervention~          interactions/week using a digital audio recorder. A research assistant will then assess~          whether the PT 1) reviewed physical activity and 2) discussed step goals. Lastly, the~          duration of the intervention will be noted.~   "
64392|NCT02724124|"~     The purpose of this study is analyze the effects of static stretching and active warm up,~     isolated and associated, in functional performance of the lower limbs in college volleyball~     athletes.~      Study hypothesis:~      H0: The stretching and / or warm up, alone or in combination, do not alter the functional~     performance of volleyball players.~      H1: The stretching and / or warm up, alone or in combination, alter the functional~     performance of volleyball players.~   "
64393|NCT02724111|"~     The investigators aim to investigate operating conditions, postoperative recovery and overall~     satisfaction of surgeons between deep neuromuscular blockade (NMB) group and restricted NMB~     group during spinal surgery under general anesthesia. The investigators hypothesize that this~     study can present good surgical conditions, postoperative recovery outcomes and overall~     satisfaction of surgeons in deep NMB group, thereby proving the advantages of deep NMB as~     well as flaws of restricted NMB in spine surgeries.~   "
64394|NCT02724098|"~     The aim of this study is to investigate the pharmacokinetics of subcutaneously administered~     dexmedetomidine in healthy volunteers. The absolute bioavailability of subcutaneously~     administered dexmedetomidine will be calculated. In addition, the investigators will report~     the effects of subcutaneously administered dexmedetomidine on plasma catecholamine levels,~     vital signs such as systemic blood pressure, heart rate and sedation. The investigators will~     also monitor the local and systemic safety and tolerability of subcutaneously administered~     dexmedetomidine.~   "
64395|NCT02724085|"~     This is a single-center, randomized, placebo-controlled, double-blind, single-ascending-dose,~     inpatient study to assess the safety, tolerability, and pharmacokinetics of TP‑271 in healthy~     subjects. Subjects aged 18 to 50 years who fulfill the inclusion/exclusion criteria will be~     enrolled in this study.~   "
64396|NCT02724072|"~     The study will assess the effectiveness, safety and clinical outcomes of the Thoraflex™~     Hybrid Device in the treatment of aortic disease affecting the aortic arch and the descending~     thoracic aorta, with or without involvement of ascending aorta.~      The study will also assess safety and early clinical outcomes in patients who receive an~     extension procedure within 1 year of Thoraflex™ Hybrid Device implantation.~      Lastly the study will assess the safety and clinical outcomes of patients who receive a~     Thoraflex™ Hybrid Device for treatment of a ruptured aorta.~      Patients will be followed for 3 years.~      The Primary Endpoint will be freedom from defined Major Adverse Events (MAE) occurring ≤ 1~     year post-procedure.~   "
64397|NCT02724059|"~     The study will include 30 patients with hilar/mediastinal lymph nodes detected by thoracic CT~     either there was a known lung malignancy (for staging purpose) or not (for diagnosing~     purpose).~      All patients will undergo to EBUS-guided TBNA. Elastography will be performed on all lymph~     nodes that will be candidates for EBUS TBNA. Mediastinoscopy or other invasive procedures~     will be performed if EBUS-guided TBNA doesn't provide representative material.~   "
64398|NCT02724046|"~     This study evaluates the effect of antibiotic prophylaxis with ciprofloxacin, given to the~     contacts of meningitis cases, on the overall attack rate of meningitis during an epidemic.~     One third of enrolled villages will receive standard care; in one-third of villages,~     household contacts of meningitis cases will be offered a single dose of oral ciprofloxacin;~     and in one-third of villages, the entire village will be offered a single dose of oral~     ciprofloxacin after the notification of the first case in the village.~   "
64399|NCT02724033|"~     The investigators would like to compare the therapeutic and cost effectiveness of established~     therapies for postoperative nausea and vomiting to regional nerve blocks of the head and neck~     area an intervention known for analgesia but for which the antiemetic effects hasn't been~     entirely explored.~      The rational is based on the knowledge of the anatomical innervation of the inner ear and the~     role of the parasympathetic nervous system in the emetic act. A lot of focus has been given~     on its counterpart the sympathetic nervous system and its role in painful conditions. The~     investigators believe that the nerve blockade of the parasympathetic innervation can have~     some beneficial effect in the post-surgical patient.~   "
64400|NCT02724020|"~     This study will evaluate the efficacy and safety of single-agent MLN0128 and the combination~     of MLN0128 + MLN1117 compared with everolimus in the treatment of participants with~     metastatic clear-cell renal cell carcinoma (mccRCC) that have progressed on vascular~     endothelial growth factor (VEGF)-targeted therapy.~   "
64401|NCT02724007|"~     The aim of this study is to validate international versions of the International~     Classification of Disease Injury Severity Score (ICISS) in adult trauma patients admitted to~     four public university hospitals in urban India.~   "
64402|NCT02723994|"~     This is a nonrandomized study of ruxolitinib in combination with a standard multi-agent~     chemotherapy regimen for the treatment of B-cell acute lymphoblastic leukemia. Part 1 of the~     study will optimize the dose of study drug (ruxolitinib) in combination with the chemotherapy~     regimen. Part 2 will evaluate the efficacy of combination chemotherapy and ruxolitinib at the~     recommended dose determined in Part 1.~   "
64403|NCT02723981|"~     Prospective, multi-centre, randomized, open-label, parallel comparisons to evaluate~        -  the incidence of bleedings (COSTA-Bleed) and~        -  the incidence of ischemic and bleeding events (COSTA-Outcome) following a therapy with~          the abluminal sirolimus coated bio-engineered stent (COMBO stent) in association with~          short-term single antiplatelet therapy as compared to a guidelines-based strategy in~          patients with coronary artery disease with an indication for chronic oral anticoagulant~          therapy.~   "
64404|NCT02723968|"~     Cystic fibrosis-related diabetes is a late cystic fibrosis (CF) associated comorbidity whose~     prevalence is increasing sharply lifelong. Guidelines for glucose metabolism (GM) monitoring~     relies on oral glucose tolerance test . However, this test is neither sensitive nor specific.~      The aim of this study is to compare sensitivity and specificity of different methods for GM~     monitoring in children and adolescents with CF.~      Continuous GM system (CGMS) will be used as the reference method. Results will be compared to~     those of oral glucose tolerance test (OGTT), intravenous glucose tolerance test (IGTT),~     homeostasis model assessment index of insulin resistance (HOMA-%IR) , homeostasis model~     assessment index of beta-cell function (HOMA-%B) and HbA1C dosage (glycated haemoglobin A1C).~     Patients will be classified into three groups according to CGMS: normal glucose tolerance,~     impaired glucose tolerance and diabetes mellitus.~   "
64455|NCT02723305|"~     This study plans to learn more about how to measure the way the the body's energy system~     works in boys with Klinefelter syndrome, including the heart, lungs, muscles, and liver. This~     is important to know so that investigators understand how hormones and an extra X chromosome~     relate to diseases such as diabetes, extra weight gain, heart disease and liver diseases.~   "
64680|NCT02720367|"~     The purpose of this study is to determine if TAR-200, an investigational drug-delivery system~     is safe and tolerable in patients with recurrent low or intermediate risk non-muscle-invasive~     bladder cancer (NMIBC) between diagnosis and transurethral resection of bladder tumors~     (TURBT)~   "
64405|NCT02723955|"~     GSK3359609 is an anti-Inducible T cell Co-Stimulator (ICOS) receptor agonist antibody~     intended for the treatment of cancers of different histology. This is a first-time-in-human~     (FTIH), open-label, multicenter study designed to investigate the safety, pharmacology, and~     preliminary antitumor activity in subjects with advanced or recurrent solid tumors with the~     aim to establish recommended dose(s) of GSK3359609 for further exploration as monotherapy and~     in combination with pembrolizumab or other immune therapies or anticancer therapies. The~     study is comprised of two primary parts, each composed of two phases: Part 1: GSK3359609~     monotherapy with Part 1A as dose escalation phase and Part 1B as cohort expansion phase; Part~     2: GSK3359609 combination therapy with Part 2A pembrolizumab combination dose escalation~     phase/safety run-in and Part 2B cohort expansion phase. GSK3359609 combinations with~     chemotherapy will only consist of safety run-in cohorts. Each part and phase of the study~     includes a screening period, a treatment period, and a follow-up period. The primary~     objective of the study is to determine the safety, tolerability, maximum tolerated dose or~     the maximum administered dose of GSK3359609 alone or in combination.~   "
64406|NCT02723942|"~     The purpose of this study is to preliminarily evaluate the safety and efficacy of CAR-T cell~     immunotherapy for GPC3 positive hepatocellular carcinoma.~   "
64407|NCT02723929|"~     The purpose of this study is to investigate the effects of transcranial direct current~     stimulation (tDCS) in conjunction with transcranial ultrasound (TUS) on pain perception and~     functional limitations in people with osteoarthritis of the knee. The investigators~     hypothesize that there will be a decrease in pain levels with active stimulation, when~     compared to sham stimulation.~   "
64408|NCT02723916|"~     High quality and effective parenting in the preschool years is connected with long term~     positive child behavior and mental health outcomes. The purpose of the study, Parent~     Training in Pediatric Primary Care: A Self-directed Tablet-based Approach, is to test the~     outcomes and implementation of a tablet-based parent training program in Pediatric Primary~     Care. Testing and evaluating the implementation of digitally delivered programs is important~     to increase the ease, reach, sustainability, and integration of mental health prevention into~     primary care settings.~   "
64409|NCT02723903|"~     A comparative study is conducted on the patients with suspected coronary artery disease~     (CAD). The patient will undergo coronary angiography after a somatic symptom scale (SSS)~     survey is carried out combining with Patient Health Questionnaire (PHQ-9) and Generalized~     Anxiety Disorder 7-items (GAD-7). Patient is then treated according to the checklist score~     and coronary angiography result. The efficacy, sensitivity and specificity of the SSS~     checklist will be evaluated during following up.~   "
64410|NCT02723890|"~     To investigate the efficacy and safety of using the novel Tyto device for remote physical~     examination by co-investigators as compared to a standard medical physical examination by~     physicians.~   "
64411|NCT02723877|"~     This study is an open-label,non randomized, multi-center, phase 1/2b (dose escalation~     followed by expansion part) study evaluating clinical safety, efficacy and pharmacokinetics~     of PQR309 in combination with standard dose of eribulin in patients with locally advanced or~     metastatic HER2-negative (escalation part) and Triple Negative Breast Cancer (expansion~     part).~   "
64412|NCT02723864|"~     Background:~      The drug cisplatin treats certain cancers when given with other chemotherapy drugs.~     Researchers think combining cisplatin with 2 other drugs could block proteins that support~     cancer cell growth. The other drugs are ABT-888 (veliparib) and VX-970. They want to test if~     this drug combination slows the growth of cancer and is safe.~      Objectives:~      To test the safety and tolerability of VX-970 and veliparib combined with cisplatin in people~     with advanced refractory solid tumors. To determine the maximum tolerated dose of these~     drugs.~      Eligibility:~      People ages 18 and older with:~        -  Solid tumors that have progressed after treatment or for which no treatment exists~        -  Normal organ and marrow function~      Design:~      Participants will be screened with:~        -  Medical history~        -  Physical exam~        -  CT scan or MRI~        -  Blood and urine tests~      Participants will get the study drugs in 3-week cycles:~        -  Cisplatin in a vein on 1 or 2 days~        -  VX-970 in a vein on 2 days~        -  Veliparib by mouth twice a day on 6 days~      In each cycle, participants will have 5 physical exams and blood tests 5 times.~      In some cycles, participants will have CT scans or MRIs.~      In cycle 1, participants may have 2 tumor biopsies. A small piece of tissue is removed by~     needle.~      Participants will keep a study diary. They will write when they take the drugs and if they~     have side effects.~      Participants will stay in the study as long as they tolerate the drugs and their tumors are~     not getting worse.~      Participants will have a phone call about a month after their last dose.~   "
64413|NCT02723851|"~     Acute Myocardial Infarction (MI) is still the leading cause of death in the western world.~     Early warning (chest pain) signs of an acute MI are often misinterpreted and disregarded. In~     average it takes between 2-3 hours from the beginning of the chest pain. The damage to the~     heart in these 2 hours is critical and often irreversible. Thus an early warning test or~     device is highly warranted.~      Corsens has developed a noninvasive device using several sensors applied to the chest and a~     detection system able to recognize the ischemic origin of chest pain. This clinical study is~     intended for evaluating the safety and efficacy of the Corsens technology while use for~     myocardial infarction detection~   "
64414|NCT02723838|"~     The purpose of this study is to investigate the safety and efficacy of intratumoral REOLYSIN®~     therapy alone and in combination with standard neoadjuvant gemcitabine and cisplatin in~     muscle-invasive bladder cancer.~   "
64425|NCT02723695|"~     The cochlear implant is an electrical hearing aid that restores the perception of surrounding~     sounds and speech intelligibility in profoundly deaf patients. During surgery, the~     labyrinthine break necessary for insertion into the cochlea of the implantable part may cause~     a malfunction of the vestibular system which can induce dizziness, balance and perception (of~     the gravitational vertical) disorders. Vestibular compensation and new sonic interactions~     could alter the balance control and the visual and postural spatial orientation perceptions.~      The usual treatment includes the monitoring of the patient's quality of life, of the~     vestibular function and of hearing. This study adds an assessment of spatial orientation and~     of posture.~   "
64426|NCT02723682|"~     A 24-hour urine pilot study was conducted as part of the 2013 NHANES to test the feasibility~     of implementing a 24-hour urine collection as part of NHANES in 2014.~   "
64415|NCT02723825|"~     Background: Epiphysis of distal end of tibia fracture is quite common in children epiphysis~     injury, because of the complex damage mechanism and often leads to growth retardation and~     joint deformity, the patient's physical and mental damage larger; also epiphysis injury~     restoration requires higher standard and more difficult to fixed, and methods are being~     actively explored to improve the curative effect and prevent the sequelae. Our hospital~     pediatric department of orthopedics expects to conduct prospective study through multi center~     to study the influence of factors such as the tibia epiphysis fracture of distal injury's~     mechanism and initial and residual displacement and treatment etc. on patients' prognosis of~     late growth disorders, joint deformity and ankle function.~      Methods and analysis: To join the multi center research collaboration group of the south~     pediatric department of orthopedics (including Pediatric Department of orthopedics of Wuhan~     Union Hospital, Wuhan Tongji Hospital, Hunan Children's Hospital, Wuhan women and children's~     Hospital, Foshan Hospital of traditional Chinese medicine, Shenzhen children's Hospital,~     Guangzhou city women and children's Medical Center), the formation of multi center research~     network, writing program, including the inclusion and exclusion criteria, grouping and~     follow-up time, method. Participating in the working group meeting, listening to the expert's~     opinions to improve research programs, formulate the tracking table of distal tibial~     epiphyseal fracture, and starting to implement after approved by the medical ethics committee~     of each hospital. The hospital is responsible for supervision in the whole process of project~     implementation, and building the real-time reporting system, and it is the responsible person~     of pediatric department of orthopedics of Foshan Hospital of TCM to do the random inspection.~     After the completion of data collection, data entry and statistical analysis conducted by the~     pediatric department of orthopedics in Foshan Hospital of TCM.~      Ethics and promotion: The research is approved by the hospital medical ethics committee of~     the south pediatric orthopedics multi center cooperative research group. Single blind method~     is performed for children in the course of the study. Research data is shared by all~     participating units and joints promotion of research results.~      Registration: To register and update the study on the United States NIH ClinicalTrials.gov~     website.~   "
64416|NCT02723812|"~     An open label, non-comparative bridging study to evaluate the safety of GCFLU® (seasonal~     influenza vaccine) administered intramuscularly in healthy Vietnamese volunteer aged from 3~     years old~   "
64417|NCT02723799|"~     This study aims to:~      I. Develop and pilot test the effectiveness of a Hope Promotion Program compared with the~     standard treatment protocol, in hope, comfort and quality of life, based on a population of~     palliative patients followed at Oncology day care unit.~      II. Evaluate perceptions and acceptability of Hope Promotion Program among palliative~     patients submitted to the intervention program.~   "
64418|NCT02723786|"~     This is a phase 2 study to evaluate the efficacy, safety, tolerability and pharmacokinetics~     of GSK1070806 in subjects undergoing renal transplantation. GSK1070806 is an anti-interleukin~     18 (IL18) monoclonal antibody, which binds to IL-18 and inhibits signaling through the IL-18~     receptor. Recipients of donor kidneys, retrieved after circulatory death of the donor, will~     be administered a single intravenous infusion of GSK1070806 to test whether inhibition of~     IL-18 can reduce the rate of Delayed Graft Function (DGF) and graft rejection. Subjects will~     be followed for 12 months post dose/transplant. Up to 40 adult subjects will be enrolled in~     this study.~   "
64419|NCT02723773|"~     The purpose of this study is a long-term follow-up of the two studies 110390 and 113077~     (ZOSTER-006/022) to assess the efficacy, safety, and immunogenicity persistence of GSK~     Biologicals' Herpes Zoster subunit (HZ/su) vaccine and will include an assessment of 1 or 2~     additional doses in two subgroups of older adults.~   "
64420|NCT02723760|"~     This is an open-label SPECT/CT (single photon emission computed tomography/computed~     tomography) study to investigate the diagnosis and efficacy evaluation performance of~     99mTc-3PRGD2 in rheumatoid arthritis patients. A single dose of nearly 11.1 MBq/kg body~     weight of 99mTc-3PRGD2 (≤20µg 3PRGD2) will be intravenously injected into the patients.~     Visual and semiquantitative method will be used to assess the whole-body planar and lesions~     section SPECT/CT images. Adverse events will also be observed in the patients.~   "
64421|NCT02723747|"~     The purpose of this study is to validate a full-automated post-processing software for~     quantitative perfusion of the myocardium with magnetic resonance imaging.~   "
64422|NCT02723734|"~     The primary purpose of this study is to determine whether a tumor test recently developed by~     GenomeDx Biosciences known as Decipher® can predict aggressive prostate cancer with the same~     accuracy in African-American men (AAM) as in non-African-American men (NAAM). The Decipher®~     test was developed from samples derived mainly from men of European origins and little is~     known about its performance in AAM. It is important to study whether this test can be used in~     AAM who are known to experience the highest rates of prostate cancer as well as death from~     prostate cancer. The use of the Decipher® test result to predict how well a patient will do~     before treatment may make it possible for doctors to distinguish aggressive disease from low~     risk prostate cancer and modify treatment accordingly. Thus, patients that do not need~     additional therapies may be spared from unnecessary side effects and those that are at risk~     may be provided with more aggressive therapy to improve survival. This study is being done to~     learn whether the Decipher test can really affect these outcomes.~   "
64423|NCT02723721|"~     Non-invasive lentigo maligna (LM) is characterized by an in situ proliferation of melanoma~     cells, limited to the epidermis. It is found most commonly on the head and neck of elderly~     persons, with a peak incidence in the seventh or eighth decade. If untreated, it may develop~     into invasive melanoma. The gold standard treatment for LM is surgery using a 5-10 mm margin.~     However, the lesions can be large, and conventional surgery can be difficult, particularly on~     the face.~      Then, there is a need for a topical non-surgical treatment of LM. Ingenol mebutate~     (IM)/Picato® is able to induce cell apoptosis and an inflammatory reaction in the epidermis~     and superficial dermis.~      Thus, the investigators hypothesize that the topical use of Picato® could induce the cure or~     a prolonged remission of non-invasive LM.~      Because of the exploratory phase of this study (no case report and no clinical trial at the~     early phase of designing this study, only one case report at the time of submission of this~     form) the investigators will conduct an open label study limited to patients who are not~     eligible to, or who refuse surgical treatment of their LM.~      The main objective of this study is to determine the proportion of patients with complete~     response (CR) obtained 2 months after one or two cycles (for patients who did not respond to~     the first cycle) of topical treatment by IM 150 µg/g for non-invasive LM of the face (head~     and neck).~   "
64424|NCT02723708|"~     The purpose of this study is to see if a non-medication intervention can increase motivation~     in individuals with ADHD by observing brain activity using magnetic resonance imaging (MRI).~   "
64427|NCT02723669|"~     This study evaluates the relative bioavailability of Acetylcysteine Effervescent Tablets~     (AR10) and Reference N-acetylcysteine. Patients will receive both products in an Open Label,~     Randomized, Two-Arm, Single-Dose, Two-Period, Crossover design.~   "
64516|NCT02722512|"~     The purpose of this study is to determine whether Heat Shock Protein Peptide Complex-96~     (HSPPC-96) Vaccine is an feasible and safe treatment for pediatric patients with~     newly-diagnosed High-Grade Gliomas or recurrent, resectable High-Grade Gliomas and~     Ependymomas.~   "
64428|NCT02723656|"~     This is a population-based randomized controlled trial of 600 patients with a diagnosis of~     cancer in the past 2 years and registry indicating smoking at the time of diagnosis, that~     will inform critical questions regarding the relative efficacy of care coordination options,~     the reliability of Electronic Health Record (EHR) tobacco use data, and how patients will~     react to proactive tobacco related communications. Investigators will compare the reach and~     efficacy of two proactive approaches to enrolling cancer survivors in tobacco treatment (Arm~     1: mailed care coordination vs. Arm 2: telephone care coordination) using a two-arm~     randomized design at two urban cancer centers, and will explore cancer survivor attitudes and~     preferences about proactive tobacco treatment.~   "
64429|NCT02723643|"~     The incidence and prevalence of hypertension is increasing while the controlled rate is~     extremely low in China. A substantial percentage of participants with uncontrolled~     hypertension are correctable if potential associated factors are identified and corrected.~     Therefore, it is clinically relevant to investigate and identify these potential associated~     factors of uncontrolled hypertension so as to increase controlled rate and reduce~     hypertension-associated health and economic burdens in the future. Investigators plan to~     conduct a prospective registry study in a single-center to initially investigate the~     potential associated factors of uncontrolled hypertension in cardiovascular outpatient~     department. Furthermore, investigators plan to evaluate the effects of potential associated~     factors correction on hypertension controlled rate and cardiovascular outcomes.~   "
64430|NCT02723630|"~     This will be a randomized, single dose, open-label, three-treatment period crossover study in~     healthy participants to determine whether 2 test lots of 10-mg capsules that vary by the~     level of lenvatinib Type-C crystal are bioequivalent to a reference lot of 10-mg capsules.~   "
64431|NCT02723617|"~     The objective of this study is to evaluate the effects of different quantities of lean beef~     (0.5, 2.5, 5.5 oz/day) on lipids, lipoproteins, and vascular health endpoints in the context~     of a modified Mediterranean dietary pattern that is representative of foods typically~     consumed in the United States.~   "
64432|NCT02723604|"~     The overall purpose of this study is to examine the efficacy of prophylactic low-level laser~     therapy (LLLT) to reduce the incidence of oral mucositis and adverse events in patients~     receiving combined modality therapy consisting of chemotherapy and radiation therapy for head~     and neck cancer.~   "
64433|NCT02723591|"~     This study will compare the incidence of a two-part composite endpoint consisting of de novo~     donor specific antibody (DSA) formation or a designation of immune activation (IA) on~     peripheral blood molecular profiling in patients maintained on twice daily, immediate-release~     tacrolimus versus those maintained on Astagraf XL in the first two years post-transplant.~   "
64434|NCT02723578|"~     Pemetrexed is a multitargeted antifolate, which primarily inhibits thymidylate synthase,~     dihydrofolate reductase, and glycinamide ribonucleotide formyltransferase in the~     folate-dependent metabolic process. Nowadays, pemetrexed is used to treat malignant pleural~     mesothelioma and non-squamous non-small cell lung cancer. Preclinical and clinical studies~     showed that pemetrexed had cytotoxic activity in many kinds of cancers including colorectal~     cancer. Erlotinib is a tyrosine-kinase inhibitor of EGFR, which was approved for the~     treatment of non-small cell lung cancer. Erlotinib also showed activity to colorectal cancer~     cells. Recently, Zhang et al. demonstrated synergistic cytotoxicity of pemetrexed and~     gefitinib in preclinical study.~      In this multicenter, non randomized, open label phase II study, investigators aimed to~     evaluate the efficacy and safety of Pemetrexed and Erlotinib combination.~   "
64435|NCT02723565|"~     This study will evaluate the heart, lungs and diaphragm of patients who fail a trial of~     spontaneous breathing to determine the physiological mechanism of weaning failure.~   "
64436|NCT02723552|"~     TEPHRA investigates the effect of exercise on blood pressure and other cardiovascular factors~     in young adults with different birth histories. TEPHRA will recruit 200 participants from~     18-35 years old with elevated blood pressure (100 participants pre-term born and 100~     full-term born). Half of the participants from each birth group will be randomised into a 16~     week supervised aerobic exercise intervention trial and the other half will be controls.~      Participants will complete 3 main study visits:~        -  Visit 1: Baseline visit conducted at beginning of study~        -  Visit 2: 16 weeks into study (upon completion of structured exercise intervention for~          the exercise group)~        -  Visit 3: End of study (52 weeks) Each visit will repeat the same set of cardiovascular~          measures including CPET, echo, blood pressure, vascular stiffness, and other measures.~           50 participants from each group will complete an MRI sub-study of the heart, brain, and~          liver.~   "
64437|NCT02723539|"~     This is a randomized, double-blind, placebo-controlled, multi-center study, in patients with~     moderate to severe diabetic foot infection (DFI), that will be conducted in two parts. In~     Part I, patients will be enrolled into 1 of 3 escalating dose cohorts at a ratio of 3:1~     (Active to Placebo). In Part II, patients will be randomized in a 1:1 ratio (Active to~     Placebo) based on the optimal dose demonstrated in Part I. Patients will be randomized to~     receive either topical application of MBN-101 or topical application of vehicle, applied~     directly to the target site, 3 times per week, for a minimum of 14 days and up to a maximum~     of 21 days. All patients will also receive systemic antibiotic treatment.~   "
64438|NCT02723526|"~     As prostate cancer progresses, tumor cells dissociate and enter the bloodstream. Considered a~     liquid biopsy, these circulating tumor cells (CTC) can show how a patient's cancer evolves~     and responds to treatments. The purpose of this study is to determine whether sequentially~     analyzing the expression of tumor markers in circulating tumor cells in newly diagnosed~     metastatic hormone-sensitive prostate cancer patients can predict the outcome of these~     patients.~   "
64439|NCT02723513|"~     The investigators will apply xenon-129 (129Xe) and non-contrast enhanced magnetic resonance~     imaging (MRI) acquisition and analysis methods in 50 subjects aged between 20 and 29 years~     born pre-term (with and without a diagnosis of bronchopulmonary dysplasia [BPD]) and at term~     to characterize and probe the relationship between lung structure and function using imaging.~   "
64440|NCT02723500|"~     Subjects aged 18-85 with lung disease will undergo hyperpolarized Xenon 129 (129-Xe) MRI and~     Pulmonary Function testing for the development of tools to evaluate the Apparent Diffusion~     Coefficient (ADC) and ventilation defect volume obtained by analysis of hyperpolarized 129-Xe~     MRI.~   "
64444|NCT02723448|"~     The goal of the investigator is to utilize Aclarubicin to treat patients with Retinal~     Vasculopathy with Cerebral Leukodystrophy (RVCL), a rare and devastating genetic disease with~     no available specific treatment. RVCL results from a mutation in the tail end of the TREX1~     (Three Prime Repair Exonuclease 1) gene, a major deoxyribonucleic acid (DNA) repair enzyme.~     The RVCL-specific mutations cause expression of a truncated and mislocalized protein. RVCL is~     an inherited disorder whose symptoms begin at middle age and initially predominantly affects~     the eye and brain. Because it is an 'autosomal dominant' disease, it strikes both males and~     females equally. A person with RVCL has a 50-50 chance of transmitting the gene to each~     child.~      The investigator's published studies demonstrated in a mouse model for RVCL and in vitro~     studies with patients' cells that defects were corrected by use of Aclarubicin, an~     anthracycline antibiotic often used to treat cancer. Thus, there is a strong rationale for~     conducting a clinical trial of aclarubicin in patients with RVCL.~      The dosage to be initially administered to RVCL patients initially will be < 10% of that~     typically used in cancer therapeutics and will be given monthly on four consecutive days for~     six months. Patients will undergo assessments every six months to determine disease response.~     Patients that do not have clear objective response may be dose escalated by 1 dose level with~     permission of the principal investigator permitting the patient has not previously~     experienced any toxicities requiring dose modifications. We will evaluate the safety and~     clinical efficacy of Aclarubicin for the treatment of RVCL and evaluate its effects on~     cellular function. This work will generate the first clinical research data on the~     investigational product's utility in treating RVCL.~   "
64445|NCT02723435|"~     This phase 2 trial studies the side effects and how well midostaurin works in treating older~     patients with acute myeloid leukemia with change in genetic material post-hematopoietic cell~     transplantation. Midostaruin may stop the growth of cancer cells by blocking some of the~     enzymes needed for cell growth. Giving midostaruin post-transplant may improve patient~     outcomes.~   "
64446|NCT02723422|"~     The primary purpose of this this randomized interventional study is to determine if increased~     level of home-based rehabilitation coupled with a pre-TAVR consultation visit in~     transcatheter aortic valve replacement patients will improve functional status and quality of~     life and will decrease hospital readmission.~   "
64447|NCT02723409|"~     The primary objective of the study will be to determine which of five traditionally used~     umbilical reconstructive techniques offers superior aesthetic results. Additionally,~     secondary objectives of post-operative complications such as hypertrophic scar formation will~     also be measured.~   "
64448|NCT02723396|"~     Sleep benefit (SB) is a prominent spontaneous, apparently unpredictable, transitory~     improvement in motor function reported by around 50% of patients affected by Parkinson's~     Disease (PD) after sleep and before taking their first dose of dopaminergic medications. This~     study aims at systematically characterizing SB in PD patients in an ecological setting and to~     explore the relationships between nocturnal and diurnal sleep and subjective and objective~     measures of motor function. A better understanding of this phenomenon is mandatory for future~     research on this topic.~   "
64449|NCT02723383|"~     Background: Alcohol is the leading psychoactive substance consumed in France, with about 15~     million regular consumers. The National institute on Alcohol Abuse and Alcoholism (NIAAA)~     considers alcohol abuse to be more than 14 units of alcohol a week for men and 7 units for~     women. The specific complication of alcoholism is the alcohol withdrawal syndrome. Its~     incidence reaches up to 30% and its main complications are Delirium Tremens, restlessness,~     extended hospital stay, higher morbidity, psychiatric and cognitive impairment. Without~     appropriate treatment, Delirium Tremens can lead to death in up to 50% of patients.~      Methods/Design: This prospective, randomised, controlled study versus placebo will be~     conducted in twelve French intensive care units (ICU). Patients with an alcohol intake higher~     than the NIAAA threshold, under mechanical ventilation, will be included. The primary~     objective is to determine whether Baclofen is more efficient than placebo in preventing~     restlessness-related side effects in ICU. Secondary outcomes include mechanical ventilation~     duration, length of ICU stay, cumulative doses of sedatives and painkillers received within~     28 days of ICU admission. Restlessness-related side effects are defined as unplanned~     extubation, Medical disposal removal, falling out of bed, ICU runaway, immobilisation device~     removal, self-aggression or towards medical staff. Daily doses of Baclofen/placebo will be~     guided by creatinine clearance assessment once a day.~      Discussion: Restlessness in alcoholic patients is a life-threatening issue in ICUs. BACLOREA~     is a randomised study assessing the capacity of Baclofen to prevent agitation in~     mechanically-ventilated patients. Enrolment of 314 patients will begin in June 2016 and is~     expected to end in June 2018.~   "
64450|NCT02723370|"~     The purpose of this study is to compare the effect of physician education about evidence~     based practices for colonoscopy alone, versus physician education plus a multi-component~     staff implementation strategy to improve adequacy of bowel preparation. Additionally the~     investigators will examine implementation factors that influence adoption of the evidence~     based practices.~   "
64451|NCT02723357|"~     The investigators have partnered with financial coaching organizations to establish what the~     investigators have termed a Medical-Financial Partnership (MFP) that offers financial~     coaching to improve financial and mental health. The investigators will evaluate the MFP's~     impact on mental health using the Kessler-6 emotional distress scale.~   "
64452|NCT02723344|"~     Exaggerated inflammation in the body and brain is thought to play a role in the vulnerability~     to and aggravation and perpetuation of adverse consequences among those with co-occurring~     mild TBI (mTBI) and post-traumatic stress disorder (PTSD). The proposed study begins the~     process of investigating the use of a natural immunoregulatory/anti-inflammatory probiotic to~     treat chronic symptoms associated with co-occurring mTBI and PTSD among Veterans. By looking~     at the impact of probiotic supplementation on biological signatures of increased~     inflammation, as reflected by the gut microbiota, gut permeability, and biomarkers of~     peripheral inflammation, this study may lead to the identification of a novel intervention~     for the treatment of symptoms associated with these frequently co-occurring conditions.~   "
64453|NCT02723331|"~     The objective of this study is to estimate the R0 resection rate in patients with Resectable~     Pancreatic Ductal Adenocarcinoma (R-PDAC) as well as those with Resectable Pancreatic Ductal~     Adenocarcinoma (BR-PDAC) independently in response to neoadjuvant sequential therapy of~     combination nab-paclitaxel and gemcitabine followed by stereotactic body radiotherapy (SBRT).~   "
64456|NCT02723292|"~     As part of a 5-year national effort to reduce teen pregnancy, the University of Rochester is~     partnering with the City of Rochester Department of Recreation and Youth Services to evaluate~     the City's replication of the Teen Outreach Program (TOP™) for 11-14 year old youth~     registered at 11 selected Recreation Centers (RCs). A youth development program with~     demonstrated efficacy to reduce teen pregnancy, school failure and drop-out rates, TOP™ has~     never been studied in RCs. Advancing from efficacy to effectiveness, the investigators will~     also measure program fidelity obtained in RCs.~   "
64457|NCT02723279|"~     The purpose of this study is to compare the efficacy of electrical pudendal nerve stimulation~     (EPNS) and Tolterodine Tartrate in patients with urgency-frequency syndrome.~   "
64458|NCT02723266|"~     The purpose of this study is to modify an existing Reproductive Health intervention for~     adolescents with diabetes for Gestational Diabetes and make it culturally appropriate~     American Indian/Alaska Native adolescents. The intervention will then be evaluated for~     effectiveness in AI/AN female teens at risk for GDM.~   "
64459|NCT02723253|"~     Neoadjuvant chemoradiation (CRT), is considered the standard treatment of locally advanced~     rectal cancer with a positive impact on locoregional control and survival.However, patients~     with T4 rectal cancer show high risk of local recurrence after conventional treatment.~     Therefore investigators designed a prospective Phase II study on patients with locally~     advanced rectal cancer or locally recurrences, to evaluate the efficacy in terms of~     pathological response and resectability of concomitant boost RT (55 Gy/5 weeks) with~     concurrent Raltitrexed and Oxaliplatin (Tom-Ox) chemotherapy.~   "
64460|NCT02723240|"~     A two-part, phase I open label, dose escalation and expansion study to assess safety,~     pharmacokinetics and clinical activity of NUC-3373, a nucleotide analogue, in participants~     with advanced solid tumours.~   "
64461|NCT02723227|"~     The investigators have partnered with financial coaching organizations to establish what the~     investigators have termed a Medical-Financial Partnership (MFP) that offers financial~     coaching to improve financial and mental health. The investigators will evaluate the MFP's~     impact on family economic strain and parental stress.~   "
64462|NCT02723214|"~     The purpose of the present study is to compare the characteristics, i.e. efficacy, duration,~     safety and hospital stay, of a frameless fiducial-less brain biopsy method with those of the~     standard frame-based stereotactic technique.~      Inclusion criteria: adult patients with cerebral lesions: 1) for whom no conclusive diagnosis~     could be settled in a noninvasive manner; and 2a) who also had surgically inaccessible~     lesions (or involving eloquent areas), or multifocal lesions, or lesions for which the~     probable diagnosis is a contraindication for craniotomy, or 2b) were too ill or too old for~     open craniotomy.~      Type of Intervention: standard frame-based stereotactic brain biopsy technique or frameless~     fiducial-less method using an optical based navigation system and a mini frame apparatus -~     trajectory guide.~   "
64463|NCT02723201|"~     The purpose of this study is to assess the relative bioavailability of solid oral~     formulations of TAK-020 in comparison with single dose of TAK-020 oral solution formulation~     and to evaluate the food effect and potentially the dose proportionality of the optimal oral~     solid formulation.~   "
64464|NCT02723188|"~     The aim of this study is to examine the effects of transcranial electrical stimulation on~     processes associated with fear extinction in healthy humans.~   "
64465|NCT02723175|"~     Investigators are seeking to determine the effects of CBT, anodal tDCS over left DLPFC, and~     combined CBT+ tDCS on clinical pain and functioning among a sample of patients with~     fibromyalgia. This study will be the first randomized, double-blind, controlled study of tDCS~     technology as an adjunctive pain management strategy for fibromyalgia pain. Data from this~     trial will likely yield information regarding the feasibility and efficacy of tDCS+CBT as a~     chronic pain-management approach.~   "
64466|NCT02723162|"~     This study will examine the effects of combining Varenicline (VRN) and N-acetylcysteine (NAC)~     on neural circuitry function and treating nicotine addiction. Healthy adult nicotine~     dependent cigarette smokers interested in quitting (n=110) will be randomized to one of four~     PBO-controlled conditions for 4 weeks: 1) VRN+NAC, 2) VRN+PBO, 3) NAC+PBO or 4) PBO+PBO.~     Following 1 week of medication, participants will be contingently reinforced for 3 days of~     smoking abstinence and be scanned using functional magnetic resonance imaging (fMRI)~     techniques, while nicotine deprived during a resting state and a cue-reactivity (CR) task.~     Participants will be followed over the next 3 weeks of treatment and clinical variables will~     be assessed.~   "
64467|NCT02723149|"~     This study aims to determine if a marijuana (MJ) Approach Avoidance Task (AAT) intervention~     reduces cannabis use compared to a control condition containing no active components of AAT.~     Adolescent heavy MJ users (N=40, ages 16-21) will be randomly assigned to MJ-AAT (n=20) or~     control condition (MJ-Sham, n=20) for three weeks. The MJ-AAT includes six sessions designed~     to reduce action tendencies to approach marijuana. The MJ-Sham includes six MJ-AAT-sham~     conditions. Substance use and cognitive assessment will identify changes in MJ use patterns~     and mechanisms of treatment outcomes. Additionally, using an functional magnetic resonance~     imaging marijuana cue reactivity task, we will determine differences in neural response in~     reward regions before and after 3 weeks of either AAT or sham treatment.~   "
64468|NCT02723136|"~     This study addresses the effectiveness of a smartphone application to improve academic~     performance among medical students. Participants will be randomised to receive an application~     developed by a team of physicians and engineers, designed to review key concepts in internal~     medicine and its subspecialties. The primary outcome will be the number of correct answers in~     a multiple choice test 4 weeks after randomisation.~   "
64469|NCT02723123|"~     Non-invasive respiratory support is routinely provided to extremely preterm infants following~     disconnection from mechanical ventilation, in the form of continuous positive airway pressure~     (CPAP) or non-invasive positive pressure ventilation (NIPPV). However, these modes remain~     sub-optimal due to lack of synchronization and upper airway defensive mechanisms that~     potentially hinder their effectiveness. Non-invasive Neurally Adjusted Ventilatory Assist~     (NIV-NAVA) is a novel mode that may overcome some of these problems but has not been~     investigated in this population. Investigators hypothesize that there will be significant~     differences in cardiorespiratory behavior in extremely preterm infants receiving CPAP, NIPPV~     and NIV-NAVA during the immediate post-extubation period.~   "
64470|NCT02723110|"~     Recent genetic association studies have identified variants in the Peptidyl-Glycine~     alpha-amidating mono-oxygenase (PAM) gene that increase the risk of diabetes likely through a~     defect in beta-cell function. This has been followed up and supported by novel kinetic assays~     and cellular studies. This investigation will recall heterozygous carriers of the risk allele~     at rs78408340 and age, BMI and gender matched controls from the Oxford Biobank. The study~     will compare the incretin effect, glucagon-like peptide-1(GLP-1), insulin, glucose levels and~     PAM protein activity in individuals both with and without the risk variant. The aim of the~     study is to gain mechanistic insight into the effect of the variant on human physiology and~     diabetes pathogenesis.~   "
64471|NCT02723097|"~     The objective of this protocol is to test the feasibility and acceptability of the Relaxation~     Response Resiliency Program (3RP), a psychotherapy treatment providing a variety of mind body~     skills and interventions to decrease medical and mental health symptoms and build resilience,~     in Spanish-speaking World Trade Center (WTC) survivors, and to examine its clinical~     effectiveness to reduce Post Traumatic Stress Disorder (PTSD), depression, anxiety, and lower~     respiratory symptoms (LRS) and improve psychosocial functioning.~   "
64472|NCT02723084|"~     The purpose of this study is to evaluate the efficacy and safety of 8 weeks of treatment with~     the combination regimen ABT-493/ABT-530 in comparison to sofosbuvir plus ribavirin for 12~     weeks in Hepatitis C Virus Genotype 2 (GT2) infected participants.~   "
64473|NCT02723071|"~     This study will evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy~     of ocrelizumab in participants with progressive follicular NHL.~   "
64474|NCT02723058|"~     The purpose of this study is to pilot test an adapted collaborative care model for homeless~     mothers with depression.~   "
64475|NCT02723045|"~     To determine if there is a difference in the quality of life in between patients who~     undergoes laparoscopic totally extra-peritoneal (TEP) or modified Lichtenstein hernioplasty~   "
64476|NCT02723032|"~     By integrating a miniaturized pulse oximetry sensor into the frame of oxygen delivery glasses~     which dissimulates the nasal cannula, the investigators hope to optimize and long term oxygen~     therapy (LTOT) regarding medical and social aspects. The validation of the novel SpO2 sensor~     is the first step in the concept of personalized, dynamic delivery of oxygen by eyeglasses~     using a closed-loop system.~   "
64477|NCT02723019|"~     Mi Puente (or My Bridge) is a culturally-tailored, interdisciplinary approach designed to~     support at-risk Hispanic patients and their caregivers pre- and post-hospital discharge as~     they navigate the multi-level barriers that contribute to inequities in health care access~     and use, and in turn, perpetuate disparities in cardiometabolic and behavioral health. Mi~     Puente utilizes a sustainable nurse + volunteer peer team-based model, bridging partnership~     between inpatient and outpatient care settings to meet the integrated (i.e., physical and~     behavioral) health needs of Hispanics who are hospitalized with multiple chronic~     cardiometabolic conditions and one or more behavioral health concern(s). Participants will be~     tested at Scripps Mercy Hospital - a large, non-profit, safety net hospital located in the~     US/Mexico border region of South San Diego County, CA. The proposed randomized controlled~     trial will test Mi Puente versus Usual Care (evidence-based, best practice discharge~     procedures) in improving hospital utilization, patient-reported, and cost effectiveness~     outcomes. Electronic medical records (EMR) will be used to identify eligible patients and~     examine primary outcomes.~   "
64478|NCT02723006|"~     The purpose of this study is to determine the initial safety profile and initial antitumor~     activity of the combination treatments (immune checkpoint inhibitors [nivolumab, ipilimumab]~     with investigational drugs [TAK-580, TAK-202 (plozalizumab), vedolizumab]) in the 3 arms when~     administered to participants with advanced melanoma.~   "
64479|NCT02722993|"~     To assess the effect of a probiotic product, when co-administered with antibiotics, on~     gastrointestinal symptoms following antibiotic treatment in children.~   "
64480|NCT02722980|"~     The aim of the current study is to evaluate the efficacy of a probiotic product on bone~     mineral density (BMD) in healthy early post-menopausal women, compared to placebo. The~     primary endpoint is to assess changes of BMD at lumbar spine after an intervention period of~     12 months. Changes in BMD at the femoral neck (hip) will also be measured as well as changes~     in bone turnover markers during the period of 12 months.~   "
64481|NCT02722967|"~     This study will assess the helpfulness of the integrated call center in optimizing use of the~     Digital Medicine System in adult subjects with Schizophrenia, Major Depressive Disorder, or~     Bipolar Disorder taking oral aripiprazole.~   "
64482|NCT02722954|"~     The purpose of this study is to test the efficacy and safety of an experimental drug,~     demcizumab, when given in combination with pembrolizumab. Demcizumab is a humanized~     monoclonal antibody and was developed to target cancer stem cells. Demcizumab may block the~     growth of cancer stem cells, the remaining cancer cells, and it may also impair the~     productive growth of new blood vessels, which tumors need to grow and spread.~      This study is sponsored by OncoMed Pharmaceuticals, which is referred to as OncoMed or the~     Sponsor in this consent form.~   "
64483|NCT02722941|"~     The purpose of this study is to learn more about ways to prevent or delay relapse of multiple~     myeloma (MM). This study will determine the best dosing schedule of LBH589 maintenance~     therapy as well as the safety (side effects) and tolerability of LBH589 maintenance therapy~     after autologous hematopoietic cell transplant (HCT).~   "
64484|NCT02722928|"~     The aim of this study is to compare the incidence and volume of postoperative pneumocephalus~     in patients receiving ventilation with 100% oxygen during the last stage of surgery versus a~     conventional 1:1 oxygen/air gas mixture.~   "
64485|NCT02722915|"~     The aim of the study is the examination of brain plasticity on verbal auditory hallucinations~     (AVH) after neuromodulation with fMRI (functional magnetic resonance imaging) neurofeedback.~     During the training of fMRI neurofeedback subjects are trained to regulate consciously the~     connectivity of areas which are associated with hallucinations.The aim is to improve~     perceived hallucinations' intensity in everyday life of the patients as well as investigating~     the impact of neurofeedback on resting-state networks in the brain. As control groups,~     control subjects without AVH and participants with AVH, but no psychiatric diagnosis will be~     included.~   "
64517|NCT02722499|"~     The aim of this study is to test the efficacy of financial incentives augmented~     telephone-delivered diabetes education and skills training intervention in improving HbA1c~     levels in African Americans (AA) with type 2 diabetes (T2DM).~   "
64486|NCT02722902|"~     Insulin resistant subjects and type 2 diabetic patients are characterized by a decreased~     metabolic flexibility: a reduced capability to switch from fat oxidation in the basal state~     to carbohydrate oxidation in the insulin-stimulated state. This metabolic inflexibility is an~     early hallmark in the development of diabetes. Recent evidence suggests that a low carnitine~     availability may limit acetylcarnitine formation, thereby reducing metabolic flexibility.~     Thus, when substrate flux in the muscle is high, acetyl-CoA concentrations increase, leading~     to inhibition of pyruvate dehydrogenase (PDH) and thereby reducing glucose oxidation. The~     conversion of acetyl-CoA to acetylcarnitine relieves this acetyl-CoA pressure on PDH. To~     provide more direct insight into the effect of carnitine in preventing metabolic~     inflexibility and insulin resistance and to further explore the mechanism of action is the~     focus of this research. Here, we hypothesize that the capacity to form acetylcarnitine may~     rescue lipid-induced insulin resistance. To this end, insulin resistance will be induced by~     lipid infusion in healthy volunteers and it will be tested whether carnitine co-infusion can~     alleviate insulin resistance.~   "
64487|NCT02722889|"~     Aim of this study is to measure length of the ascending aorta in adults and to investigate~     the clinical implication of 'elongation' of the aorta.~   "
64488|NCT02722876|"~     The purpose of this study is to evaluate the efficacy of a cross-education rehabilitation~     intervention following anterior cruciate ligament reconstruction on ameliorating the acute~     losses to function and performance. The cross-education phenomenon describes the strength~     gain in the opposite, untrained (surgical) limb following unilateral resistance training of~     the 'trained' (non-surgical) limb.~   "
64489|NCT02722863|"~     This Post-Marketing Surveillance will be conducted in accordance with the local regulation of~     New Drug Re-examination. The surveillance will be conducted for 6 years of the re-examination~     period (01Sep2011~31Aug2017). Each subject will be observed at least for 4 days during the~     surveillance period.~   "
64490|NCT02722850|"~     In this parallel group study, participants were randomized to either 1 of 3 conditions (a)~     fruit and vegetable consumption, (b) dietary fat and added sugars, or (c) physical activity.~   "
64491|NCT02722837|"~     The primary objectives of this study are to evaluate the efficacy, safety, and tolerability~     of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) for 12 weeks~     in participants with chronic hepatitis C virus (HCV) infection.~   "
64492|NCT02722824|"~     Investigation efficacy of a non-invasive wearable electrostimulator device where the~     supplementary motor area, premotor area and/or subthalamic nucleus are stimulated bilaterally~     and extracranially.~   "
64493|NCT02722811|"~     Primary aim: evaluate efficacy of subcutaneous injection of etanercept for moderate and~     severe knee osteoarthritis.~      Second aim: investigate the potentiality of serum cytokines (TNF-α, Interleukin 1-α (IL1-α),~     IL1-β, matrix metalloproteinases1 (MMP1), MMP13) to predict the response of subcutaneous~     injection of etanercept for moderate and severe knee osteoarthritis.~   "
64494|NCT02722798|"~     The purpose of the study is to evaluate the efficacy and safety of KRN23 after its 48-week~     once every 4 weeks repeated subcutaneous administration to Japanese and Korean patients with~     Tumor-Induced Osteomalacia or Epidermal Nevus Syndrome by a multicenter, open-label,~     intraindividual dose adjustment study~   "
64495|NCT02722785|"~     Background:~      For patients diagnosed with operable cancer of the gastro-esophageal junction (GEJ), the~     perioperative course of therapy is associated with severe deconditioning which includes~     weight loss and poor physical function, which are strong predictor of post-surgical~     complication and survival . A strong rationale exists to explore how to develop supportive~     interventions aimed at maintaining/improving muscle function (lean body mass and muscle~     strength) during the pre-surgical phase.~      This study explores the safety, feasibility and efficacy of structured pre- and~     post-operative exercise training in patient undergoing surgery for cancer of the~     gastro-esophageal junction.~      Subjects: Patients with histologically verified, resectable adenocarcinoma of the GEJ~     scheduled for treatment af Rigshospitalet, Copenhagen, Denmark.~      Methods: In a case-control design, patients will be allocated to either an exercise training~     intervention group, or a usual-care observational group, based on geographical location.~     Forty patients will be included in this case-control study and allocated by geographical~     region as follows; 20 training intervention-cases living in the greater Copenhagen area, and~     20 observational control subjects living outside the greater Copenhagen area.~      All patients will undergo a total of 5 assessments during the perioperative trajectory; twice~     prior to surgery (baseline and pre-surgery test), three post-surgery (2 week post- and 15~     weeks post-surgery, and at 1-year follow-up).~      Assessments include measures of body composition by DXA scan and bioelectrical impedance~     analysis: systemic inflammation in fasting blood sample; quality of life by self-report~     questionnaires; physical function by handgrip strength and sit-to-stand test.~      As optional procedures, we will collect biological tissue from tumor, muscle and fat biopsies~     and a 10 ml blood sample at baseline and pre-surgery test only. Also, we will collect blood~     samples before, during and after an acute exercise bout exercise in order to explore the~     acute systemic changes in exercise-regulated biomarkers.~   "
64496|NCT02722772|"~     Primary aim: evaluate efficacy of intra-articular injection of etanercept for moderate and~     severe knee osteoarthritis.~      Second aim: investigate the potentiality of serum cytokines (TNF-α, Interleukin 1-α (IL1-α),~     IL1-β, matrix metalloproteinases1 (MMP1), MMP13) to predict the response of intra-articular~     injection of etanercept for moderate and severe knee osteoarthritis.~   "
64497|NCT02722759|"~     In this prospective study different methods of haemoglobin measurement in term and preterm~     neonates are compared with the gold standard. Non-invasive haemoglobin measurement with the~     Radical-7® (SpHb, Masimo®), point-of-care haemoglobin-measurement (HcHb, HemoCue@,~     Radiometer), blood-gas-analysis (BGAHb,ABL800®, Radiometer) are compared with haemoglobin~     measurement by an automated hematology analyzer (labHb, Siemens Advia®).~   "
64498|NCT02722746|"~     Epidural analgesia via continuous epidurally infused local anesthetic agent (LA) is widely~     and very successfully used routinely for perioperative pain control in patients undergoing~     major orthopedic and abdominal surgery since 1928. The choice currently depends on the~     preference of the APS physician in charge of the case. A frequent unwanted side effect of~     epidural block is hypotension due to the epidurally injected LA blocking the sympathetic~     nerves and thus the patient's response to hypotension, which is usually due to hypovolemia~     and/or an unopposed parasympathetic (via the vagus nerve) nervous system. The purpose of this~     research study is to see if adding epinephrine, to the epidural anesthetic will decrease~     possible side effects, such as low blood pressure, and lead to a better effect of the~     epidural anesthetic.~   "
64499|NCT02722733|"~     The purpose of the study is to compare safety and efficacy of stem cell mobilization using~     G-CSF (filgrastim) alone vs. intermediate-dose cytosine arabinoside plus G-CSF in Hodgkin's~     lymphoma and non-Hodgkin's lymphoma patients.~   "
64500|NCT02722720|"~     The aim is to compare the safety of using transfemoral and transradial approach in patient~     undergoing carotid arteries stenting.~   "
64501|NCT02722707|"~     This registration is for clinical use of the FENIX, a Humanitarian Use Device (HUD) for fecal~     incontinence. This device is indicated for the treatment of fecal incontinence in patients~     who are not candidates for or have previously failed conservative treatment and less invasive~     therapy options (e.g. bulking agents, radiofrequency ablation, sacral nerve stimulation).~   "
64502|NCT02722694|"~     The primary objective of this study is to demonstrate superior efficacy of abatacept 125mg~     administrated SC weekly comparing to placebo after 24 weeks treatment in Chinese subjects who~     have active rheumatoid arthritis, are receiving methotrexate and experiencing an inadequate~     response to methotrexate. This will be estimated by the proportion of subjects meeting the~     American College of Rheumatology (ACR) criteria for 20% improvement (ACR20).~   "
64503|NCT02722681|"~     'Spinal lipoma' is a condition, present from before birth, in which fatty tissue (lipoma) is~     attached to the lower end of the spinal cord, tethering it within the vertebral canal. The~     cord normally moves up and down with respiration, whereas tethering prevents this movement,~     and can lead to progressive neurological deterioration. The cord and spinal nerves become~     stretched and their blood supply is damaged irreversibly. Disability may include weakness or~     pain in the lower body, and urinary disorders in young children. Treatment is surgical, to~     remove the lipoma and mobilise the spinal cord, with 60 such operations performed per year at~     Great Ormond Street Hospital. This project aims to develop lipidomic biomarkers in order to~     predict which children with spinal lipoma are at highest risk of neurological deterioration,~     and require early surgery, while providing evidence to adopt a more conservative approach for~     those at lower risk.~   "
64504|NCT02722668|"~     This is a phase II trial using a non-myeloablative cyclophosphamide/ fludarabine/total body~     irradiation (TBI) preparative regimen with modifications based on factors including~     diagnosis, disease status, and prior treatment. Single or double unit selected according to~     current University of Minnesota umbilical cord blood graft selection algorithm.~   "
64505|NCT02722655|"~     The aim of this study is the identification of complications in diabetes mellitus pediatric~     patients and to compare the clinical, anthropometric, and biochemical characteristics between~     children in the different types of diabetes mellitus.~   "
64506|NCT02722642|"~     Bronchiectasis is a result of chronic inflammation compounded by an inability to clear mucoid~     secretions. Inflammation results in progressive destruction of the normal lung architecture,~     in particular the elastic fibers of bronchi. Currently there is no effective drug for~     bronchiectasis. This study intends to carry out an open, single-center, non-randomized, self~     control phase I/II clinical trial. During the treatment, bronchial basal cells (BCCs) will be~     isolated from patients' own bronchi by bronchoscopic brushing and expanded in vitro. Cultured~     cells will be injected directly into the lesion by fiberoptic bronchoscopy after lavage.~     After six-month observation, the investigators will evaluate the safety and effectiveness of~     the treatment by measuring the key indicator-- the CT imaging of dilated bronchi as well as~     four secondary indicators including the pulmonary function, laboratory factor level,~     incidence of acute exacerbation and the patients' self-evaluation.~   "
64507|NCT02722629|"~     The aim of the study is to estimate the prevalence of respiratory aspiration in patients with~     COPD, in a tertiary hospital of Buenos Aires.~   "
64508|NCT02722616|"~     This research study is being done to collect data and analyze the motion of soft tissue in~     the abdomen (liver, pancreas, stomach and intestines) of people who have pancreatic and liver~     cancer as well as healthy volunteers.~      During the study researchers will look at the movement of organs in the abdomen that~     naturally occurs with breathing and with a bowel movement.~      This study will examine the differences between abdominal soft tissue motion in healthy~     volunteers and in cancer patients with the goal of developing a better way to manage and~     minimize the abdominal soft tissue motion. Accurate location of the tumor is very important~     in treatment delivery and reduction of toxicity.~   "
64509|NCT02722603|"~     This study evaluates the efficacy and safety of gabapentin relative to tramadol for the~     treatment of chronic, neuropathic or mixed pain in the paediatric population. Children from 3~     months to less than 18 years of age experiencing moderate to severe chronic pain will receive~     either gabapentin or tramadol for 15 weeks. The difference in average pain scores between~     treatment arms at the end of the treatment period will be assessed.~   "
64510|NCT02722590|"~     The objective of this post-marketing surveillance study is to observe the safety profile of~     Fycompa film-coated tablets 2/4/6/8/10/12 milligrams (mg) in a normal clinical practice~     setting.~   "
64511|NCT02722577|"~     Investigate the value of unipolar and bipolar electrograms (EGM) for predicting the~     successful ablation site for idiopathic outflow tract ventricular arrhythmia (OTVA).~   "
64512|NCT02722564|"~     This will be a prospective survey study. The participants will all be volunteers of legal~     drinking age. Each participant will consume one alcoholic beverage (beer) at a time and then~     will be asked to verbally estimate their current blood alcohol concentration and if the~     subject feels they are able to drive. At that time, their BAC level will be measured~     objectively using a breath alcohol test (BAT) device. The participant will not be told their~     objective value. This will continue with a verbal estimate and actual BAT reading after every~     drink until the participant reaches a minimum BAC of 0.10. At this time, participants will~     continue to be monitored until their BAC falls to 0.08 and they are clinically sober. As~     their blood alcohol level decreases, the investigators will ask the participant to estimate~     their level every hour along with an actual reading until reaching 0.08. Statistical analyses~     will be used to determine how accurate self estimation is in regards to blood alcohol~     content.~   "
64513|NCT02722551|"~     Clinical study to evaluate the safety and performance of the CardiAQ-Edwards™ Transcatheter~     Mitral Valve~   "
64514|NCT02722538|"~     The purpose of this study is to determine if TAR-200, an investigational drug-delivery~     system, is safe and tolerable in patients with muscle-invasive bladder cancer (MIBC) between~     diagnosis and radical cystectomy (RC).~   "
64515|NCT02722525|"~     Learning about the impact of anti-androgen treatment has on cardiac function in patients with~     prostate cancer may help plan treatment and help patients live more comfortably. This pilot~     clinical trial will utilize cardiac magnetic resonance imaging (MRI) before a patient starts~     hormone therapy and after 4 to 7 months of hormone therapy. The objective is to measure the~     impact of hormone therapy (anti-androgen treatment) on cardiac function in patients with~     prostate cancer.~   "
64518|NCT02722486|"~     The investigators aim to compare rehabilitation progress between control patients who will~     undergo routine vestibular rehabilitation exercises and experimental patients who will~     undergo exercises using a vibrotactile balance belt (Sensory Kinetics Balance Rehabilitation~     System) in addition to their routine vestibular rehabilitation regimen during recovery from~     diseases affecting the vestibular system. The results of this pilot study will help to~     determine if the vibrotactile balance belt is a useful supplement to traditional vestibular~     rehabilitation techniques in children suffering from vestibular impairment.~   "
64519|NCT02722473|"~     Cardiac arrest is at present a major cause of mortality as well as a cause of disability for~     the surviving victims.In Europe, every year counts as 300,000 cardiac arrests responsible for~     250,000 deaths. Thus, less than 20 % of patients discharged home with impaired quality of~     life associated with symptoms of tiredness, stress, anxiety. The prognosis is related to the~     initial cardiac rhythm present during the initiation of resuscitation. Recent progress in the~     improvement of mortality and neurological outcome has been achieved over the last decade~     thanks to the systematic implementation of a period of targeted temperature control between~     32 and 34 ° C in patients who benefited from the realization of at least one electrical~     external shock.~      There are theoretical and clinical arguments to think that achieving the same way a period of~     targeted temperature control between 32 and 34 ° C in patients treated for cardiac arrest~     with a non- shockable rhythm on arrival can also benefit from this procedure. However other~     arguments are against this hypothesis including an increase in the risk of infection ,~     worsening of the patient's hemodynamic status with no benefit to him. To answer this~     question, we conduce a randomized multicenter study testing the potential improvement of~     neurological outcome through this procedure targeted temperature control between 32.5 and~     33.5 ° C in these patients.~      NSE-Ancillary Study of HYPERION Trial will determine impact on neurospecific enolase (brain~     biomarker) of two temperature target for targeted temperature management (33°C or 37°C) after~     cardiac arrest in non-shockable rhythm.~   "
64520|NCT02722460|"~     The aim of the study is to determine surrogate markers for prognostication of unfavorable~     outcome (death or persistent vegetative state) in cardiopulmonary arrest survivors. These~     patients are comatose. Conscious patients are unsuitable for prognostication.~   "
64521|NCT02722447|"~     The treatment of isolated distal deep vein thrombosis remains one of the most debated issues~     in the field of venous thromboembolism and only very few studies have directly addressed the~     issue of treatment in objectively confirmed isolated distal deep vein thrombosis. Aim of this~     study is to assess the long-term risk of recurrent venous thrombotic events in patients with~     a first acute symptomatic isolated distal deep vein thrombosis of the leg treated with a~     standard (12 weeks) or with a shorter (6 weeks) duration of therapy with rivaroxaban.~   "
64522|NCT02722434|"~     This randomized clinical trial studies how well MC5-A scrambler therapy or transcutaneous~     electrical nerve stimulation (TENS) therapy work in treating patients with~     chemotherapy-induced peripheral neuropathy (a nerve problem that causes pain, numbness,~     tingling, swelling, or muscle weakness in different parts of the body). MC5-A scrambler~     therapy is a type of treatment for nerve pain that uses electrodes placed on the skin, where~     electricity is carried from the electrodes through the skin and blocks the pain. TENS is a~     procedure in which mild electric currents are applied to some areas of the skin. It is not~     yet known whether TENS therapy is more effective than MC5-A scrambler therapy in treating~     chemotherapy-induced peripheral neuropathy.~   "
64523|NCT02722421|"~     The purpose of this study is to determine whether increasing the dose of the levonorgestrel~     subdermal contraceptive implant will overcome a detrimental drug-drug interaction with~     efavirenz based antiretroviral therapy.~   "
64524|NCT02722408|"~     The purpose of this study is to assess the efficacy, safety, and tolerability of multiple~     doses of Gemcabene in patients with HoFH on stable, lipid-lowering therapy.~   "
64525|NCT02722395|"~     This study is a research and development initiative established to explore the use of~     magnetic resonance imaging (MRI) as a tool for managing organ motion of the liver in cancer~     patients planning procedures for stereotactic body radiation therapy (SBRT).~   "
64526|NCT02722382|"~     Objective: The investigators will change the health system to improve care patients receive~     as they transition through earlier stages of kidney disease toward kidney failure. They will~     study whether these changes lead to patients' improved health and well-being.~      Methods: The investigators will conduct this study in Geisinger Health System kidney~     specialty clinics. The study will implement 'Patient Centered Kidney Transitions Care' which~     will (1) give doctors tools to help them recognize when patients should prepare for kidney~     failure and help them support patients' early and informed treatment decisions; and (2) add a~     'Kidney Transitions Specialist' to the health care team to help patients learn about kidney~     disease, learn self-care skills, make informed decisions, get psychosocial support, and~     coordinate their care. Four (4) clinics will be randomly assigned to provide Patient Centered~     Kidney Transitions Care, and four (4) to provide their usual care. The investigators will~     study differences in patients' outcomes among those treated in clinics providing Patient~     Centered Kidney Transitions Care compared to those treated in clinics providing usual care.~      Patient Outcomes: Patients have told us they want to have 'control' over their disease~     transitions and to have the best quality of life possible. The investigators will measure~     patients' empowerment, confidence with their self-care, their decisions to start self-care~     treatments for kidney failure, and their hospitalizations. They will also measure whether~     doctors record patients' treatment preferences in the medical record before patients develop~     kidney failure.~      Patient and Stakeholder Engagement: This study responds to reports from hundreds of patients~     and caregivers who want better care. Patients and caregivers from around the US are part of~     our investigative team, and they will participate in all aspects of our study. The~     investigators are also engaging key stakeholders in the kidney community, including patients,~     providers, payers, and regulators.~      Anticipated Impact: If effective, Patient Centered Kidney Transitions Care will provide a~     model of care can improve the lives of patients and families with kidney disease across the~     US.~   "
64527|NCT02722369|"~     To determine whether the combination of gemcitabine/carboplatin with hydroxychloroquine (HCQ)~     is associated with an improved clinical outcome (progression free and overall survival)~     compared with chemotherapy alone in patients with small cell lung cancer (SCLC)~   "
64542|NCT02722174|"~     The study aims to examine a battery of behavioral and questionnaire measures in 4 disorders~     clinically associated with impulsivity and in health controls, to: 1) investigate if the~     different populations have a distinct behavioral profile, and 2) to investigate if there are~     specific measures that are reliable and sensitive measures of impulsivity across diagnoses.~   "
64543|NCT02722161|"~     To investigate the basic pharmacokinetics of BI 1482694, its metabolites M1 and M2, and~     [14C]-radioactivity, including mass balance, excretion pathways and metabolism following a~     single oral dose of [14C]BI 1482694 given to healthy male volunteers~   "
64544|NCT02722148|"~     This is a prospective single center clinical trial of allergen-specific immune~     signature-guided dietary elimination therapy to assess the clinical effectiveness of this~     technique.~   "
64528|NCT02722356|"~     The proposed study is a prospective, randomized, active control, open label study. One~     hundred sixty subjects undergoing elective cesarean section will be randomly assigned to one~     of two groups (n = 80 per group): the oxytocin protocol group or the standard practice group.~     The oxytocin protocol group will receive oxytocin boluses along with a regulated infusion~     according to a stepwise algorithm following delivery of the placenta. The standard practice~     group will receive oxytocin via a free flowing (wide-open) infusion with a concentration of~     30 IU per 500 mL of 0.9% normal saline following the delivery of the placenta. Primary~     outcomes include uterine tone (adequate or inadequate) as assessed by the surgeon, amount of~     time required to establish adequate uterine tone following the delivery of the infant, total~     dose of oxytocin required to establish adequate uterine tone, and total calculated blood loss~     based on pre-operative and post-operative hematocrit concentrations. Secondary outcomes~     include total estimated blood loss as agreed upon by the surgeon and the anesthesia provider,~     use of additional uterotonic drugs, mean arterial pressure, and incidence of oxytocin side~     effects (nausea, chest tightness/pain, and ST-segment changes).~   "
64529|NCT02722343|"~     This single site study is designed to describe and measure the efficacy of oral versus~     vaginal dosing of TFV-based products, specifically emtricitabine/tenofovir disoproxil~     fumarate oral tablets (Truvada) vs tenofovir intravaginal rings (IVR).~   "
64530|NCT02722330|"~     The aim of this clinical investigation is to evaluate objective and subjective hearing~     performance with the Cochlear Baha 5 SuperPower Sound Processor on the Baha Attract System,~     compared to the unaided hearing performance. Comparison of audiological test results with the~     same sound processor on a Baha Softband will also be performed. Short term safety parameters~     will be collected.~   "
64531|NCT02722317|"~     It was realized a case study in a batterer intervention program, where 86 men accepted to~     participate. It was used the Centers for Disease Control and Prevention - Follow up~     questionnaire, adapted to be used in Brazil.~   "
64532|NCT02722304|"~     The purpose of this study is to conduct a pilot study to evaluate the safety and efficacy of~     weekly administration of Alpha1-Proteinase Inhibitor (A1PI) augmentation therapy in subjects~     with A1PI deficiency and emphysema/ Chronic obstructive pulmonary disease (COPD).~   "
64533|NCT02722291|"~     This study is aimed at presbyopic patients that do not require magnifying glass at close~     rage. The purpose of this study is to investigate the functional and physiological changes in~     eye induced by pinhole glass.~   "
64534|NCT02722278|"~     A Phase 3, Randomized, Active-controlled, Open-label Study of the Safety and Efficacy of Oral~     Testosterone Undecanoate (TU) in Hypogonadal Men~   "
64535|NCT02722265|"~     To examine antihypertensive effect, pharmacodynamics, and safety of long-term administration~     of CS-3150 as monotherapy and in combination with calcium channel blocker or~     renin-angiotensin system inhibitor in patients with essential hypertension.~   "
64536|NCT02722252|"~     The centre for Medically-Assisted Procreation (MAP) of Dijon CHU has two high-technology~     embryo culture systems, with incubation characteristics that are potentially superior to~     those provided by classical culture systems. Indeed, these two systems, available in only two~     MAP centres in France, make it possible to maintain a stable temperature and gaseous~     environment during the in-vitro development of the embryos.~      It is necessary to observe the development of the embryos to determine which embryos have the~     highest implantation potential. These observations are done from time to time by microscope~     for one system and continuously using an incorporated video camera for the other~     (cinematographic study). The MAP centre in Dijon wishes to compare the interest of these two~     systems.~   "
64537|NCT02722239|"~     The aim of this study is to demonstrate bioequivalence of fixed dose combination~     Dapagliflozin + Metformin modified -release, film-coated tablets, 10 mg + 1000 mg,~     (AstraZeneca AB, Sweden) versus Forxiga™ (Dapagliflozin), film-coated tablets, 10 mg (Bristol~     Myers Squibb Company, USA) and Glucophage® long (Metformin), ER tablets, 1000 mg (2 x 500 mg)~     (Merck Santé S.A.S., France) which are already registered in the Russian Federation.~   "
64538|NCT02722226|"~     Objective Sedation is a depression of consciousness varies between anxiolysis and general~     anesthesia. It is used to facilitate diagnostic tests and minor surgeries. Respiratory~     complication is the main side effect of the sedation. His Early diagnosis and adequate~     management prevent serious complications such as hypoxic brain damage or death. A development~     of a learning program of sedation is required. Simulation as a teaching tool has improved the~     clinical expertise of learners. The objective of the study is to evaluate the impact of a~     simulation based medical education program on the performance of non-resident~     anesthesiologists for the management of complications related to sedation.~      Methods This trial is randomized, controlled and single blinded. Non-resident~     anesthesiologists, without prior training on sedation, are included and randomized to receive~     or not a simulation based sedation learning. This program includes a pharmacology sedatives~     learning, teaching technical skills for airway management on low fidelity mannequin and~     high-fidelity simulation scenarios of these complications. Two evaluators, single-blinded,~     visualise the recorded performance of residents in simulation session. The evaluation is~     based on a performance checklist developed by Delphi technique. It compares the performance~     of the residents within the same group before and after the simulation based medical~     education program and to compare groups of residents.~      Data analysis The sample size is based on similar simulation studies. The results are~     compared with the variance analysis for repeated measures. The difference in performance~     before and after simulation is compared using a t test.~      The investigators hypotheses that improved performance scores following the simulation based~     medical education would put the dot on the importance of simulation as a learning tool.~   "
64539|NCT02722213|"~     The guideline-recommended standard of care for patients who have experienced a heart attack,~     heart failure, or other coronary event or procedure is exercise-based cardiac rehabilitation~     (CR). Despite proven benefits, traditional CR is severely underutilized. Moreover, what is~     typically lacking from traditional CR programs is effective psychosocial risk management.~     This represents a critical gap in care given the well-documented psychosocial needs of this~     patient population.The objective of this feasibility study is to conduct a pilot randomized~     controlled trial (RCT) of Mindfulness-Based Stress Reduction (MBSR) versus usual care in~     CR-eligible cardiac patients. Randomization will be stratified within two strata based on~     participation in CR (yes/no) among CR-eligible patients. The primary goals of this pilot~     study are to: 1) obtain estimates of treatment effects and variability; 2) evaluate~     recruitment and retention strategies; and 3) examine the safety of the MBSR protocol in~     CR-eligible patients.~   "
64540|NCT02722200|"~     The purpose of this study is to examine if glucocorticoids will change neural activation in~     regions of the corticolimbic-striatal system that regulate feeding.~   "
64541|NCT02722187|"~     This study is to set the place of microsurgery in surgical treatment od varicocele in~     infertile male. Fourty patients will undergo microsurgical subinguinal varicocelectomy while~     the control group consisting of 20 patients wil undergo laparoscopic varicocelectomy.~   "
64545|NCT02722135|"~     This is an open-label, dose-escalating trial to evaluate the MTD and/or dose to be used for~     further development by evaluation of DLT in course 1 and the safety of volasertib when added~     to standard intensive salvage chemotherapy with DNX-FLA in paediatric patients with AML after~     failure of first-line therapy. Furthermore, data on efficacy and PK/PD of volasertib in~     paediatric patients with AML when added to standard intensive salvage chemotherapy will be~     collected.~   "
64546|NCT02722122|"~     This study evaluates the Safety,Tolerability, Pharmacokinetics and Exploratory Efficacy~     Parameters of AIR DNase™in Patients with Cystic Fibrosis previously treated with Pulmozyme®.~   "
64547|NCT02722109|"~     Researchers want to compare proton stopping ratios, used for proton beam therapy planning,~     calculated based on single energy CT and dual energy CT images; with the intension of improve~     upon the proton range determination.~   "
64548|NCT02722096|"~     Recommended by the KDOQI vascular access guidelines, antebrachial arteriovenous fistula is~     the best primary vascular access for hemodialysis in patients with end stage renal disease.~     The primary complications are common, of the order of 10-36 %, including lack of maturation~     and dominated by stenosis and thrombosis.~      Local anesthesia associated with sedation is a validated method of anesthesia for made~     arteriovenous fistula but does not cause the motor block and not blocking vasospasm,~     deleterious to the surgery. Multiple injections necessary to cover the operating zone expose~     patient to pain and to intravascular injection of local anesthetics.~      Regional anesthesia provides better conditions for realize more distal fistula. Sympathetic~     block provides arterial, venous vasodilation and decreases the incidence of vasospasm . It~     enables an increased flow rate at an early time fistula and faster maturation.~      However, studies included low numbers of patient or are non-randomized. They cannot concluded~     a significant difference in the complication rate of arteriovenous fistula at an early time~     depending on the type of anesthesia .~      This study aims to demonstrate that axillary block for surgical creation of arteriovenous~     fistula allows a reduction of complications at 6 weeks compared to local anesthesia~   "
64549|NCT02722083|"~     The purpose of the study is to explore the onset of effect of an antihistamine in a~     controlled environment.~   "
64550|NCT02722070|"~     The main objective of the study is to explore and map brain areas involved in processing and~     perception in patients suffering from neurological pathologies and condition. The~     investigators hypothesize for example, that a change (compare to healthy subjects) in the~     perceptual maps and body representation could be detected and characterize in patients~     suffering from impairments of peripheral nerve conduction.~   "
64551|NCT02722057|"~     The purpose of this study is to confirm the long-term safety and effectiveness of Kalydeco®~     (ivacaftor) in US CF patients with the R117H-CFTR mutation <18 years of age and to describe~     the long-term safety and effectiveness of Kalydeco in CF patients with the R117H-CFTR~     mutation overall and in patients ≥18 years. The long-term safety and effectiveness of~     Kalydeco will be examined in totality through the evaluation of the primary outcome measures.~   "
64552|NCT02722044|"~     The purpose of this study is to evaluate the usability of an auto-injector (AI) for the~     delivery of M923 in patients with rheumatoid arthritis (RA)~   "
64553|NCT02722031|"~     Hypoxemia is usually observed during ICU stay. Nevertheless, the prevalence of hypoxemia~     among patients admitted in ICU is not well known, in partly due to a lack of a consensual~     definition. Some of these patients meet the criteria of Acute Respiratory Distress Syndrome~     whom the definition has been recently modified in 2011. Many uncertainties are remaining in~     considering the patients with ARDS: prevalence of the category of mild ARDS, the proportion~     of patients with invasive mechanical ventilation, the therapeutic modalities and the~     prognosis, in particular, the move towards a more severe ARDS category. Finally, many~     patients with hypoxemia do not meet ARDS definition. The prevalence of this population in ICU~     is unknown, likewise its prognosis. In this way, it would be interesting to compare, for each~     levels of hypoxemia (mild, moderate and severe) the prognosis of the patients with and~     without ARDS.~      The main objective of the SPECTRUM study is to assess the prevalence of hypoxemia in~     French-speaking Intensive Care Unit in 2016 in using a single-day point-prevalence study~     design. Two periods of inclusion have been, actually, planned: from the 29th Mars to the 31st~     Mars and from the 5th to the 7th April. In each participating center, the day of the study~     will be chosen among these periods.~   "
64554|NCT02722018|"~     This is a phase 1, randomized, open-label, single center, crossover study to investigate the~     effect of formulation and food on the pharmacokinetics of GDC-0810 in female healthy~     participants of non-childbearing potential. This study is divided into three parts.~     Participants in each part will be randomized to one of three treatment sequences. Part 1~     study in 4 periods will investigate the effect of formulation on the pharmacokinetics (PK) of~     GDC-0810 administered with low-fat food. Each participant in this part will receive a single~     dose of GDC-0810 dose level A following consumption of a low fat meal (30 minutes after the~     start of the meal) in each treatment period. Part 2 is an optional Phase I study in 3 periods~     to investigate the effect of formulation on the PK of GDC-0810 administered with low-fat food~     in healthy female participants of non-childbearing potential. Part 3 study in three periods~     will compare the PK of a Phase III prototype tablet formulation selected from Parts 1 and 2~     of the study with the Phase II tablet formulation (both administered 30 minutes after the~     start of a low fat meal) at dose level B and to investigate the PK of the Phase III prototype~     formulation administered in the fasted state.~   "
64555|NCT02722005|"~     The investigators have partnered with financial coaching organizations to establish what the~     investigators have termed a Medical-Financial Partnership (MFP) that offers financial~     coaching to improve financial and mental health. The investigators will evaluate the MFP's~     impact on health related quality of life using the Patient Reported Outcome Measurement~     Information System (PROMIS) 10 Global Short Form.~   "
64556|NCT02721992|"~     The investigators have recently observed retrospectively that the occurrence of Graves'~     Orbitopathy in patients with Graves' disease is less frequent in patients with normal~     cholesterol levels, in line with another recent observation suggesting that statins play a~     protective role in Graves' patients from developing Graves' Orbitopathy. The present study is~     designed in order to investigate the possible association between Graves' Orbitopathy and~     high cholesterol level as well as the relation between Graves' Orbitopathy degree and high~     cholesterol level~   "
64558|NCT02721966|"~     The purpose of this study is to demonstrate the efficacy and safety of secukinumab 150 mg or~     300 mg in the management of axial manifestations in PsA patients who have failed to respond~     to at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) over a 4-week period, according~     to assessment of spondyloarthritis international society (ASAS) recommendations for the~     treatment of axial spondyloarthritis (AxSpA).~   "
64559|NCT02721953|"~     Butyrate is a short chain fatty acid (SCFA) produced by bacterial fermentation of undigested~     starch in the gut. Butyrate carries out different effects at intestinal and extraintestinal~     level, including: immune regulation with anti-inflammatory effect at intestinal and systemic~     level and modulation of gut microbiota. Many of these effects result from an epigenetic~     mechanism. Shown in an animal model of obesity induced by a high fat diet (HFD), that~     butyrate can exercise very effective protective action against obesity through the~     stimulation of intestinal satiety hormones. Shown always in murine model of obesity induced~     by HFD, that butyrate is effective in preventing and treating obesity and insulin resistance.~     After 5 weeks of treatment with butyrate was observed a reduction of 10.2% of body weight,~     30% of fasting glucose and 50% insulin resistance.~      In an animal model of metabolic syndrome with NAFLD researchers have recently demonstrated~     that the administration of butyrate is able to significantly reduce insulin resistance, liver~     damage, dyslipidaemia through a modulation of the inflammatory process.~      Pharmacokinetic and pharmacodynamic studies in humans show that the oral administration of~     butyrate is safe and well tolerated. The peak serum levels occurs 4-6 hours after oral~     administration.~      All of these data makes plausible a possible positive effect on insulin resistance in the~     obese child.~   "
64560|NCT02721940|"~     This study was mainly aimed to evaluate the efficacy of local administration of enriched bone~     marrow mononuclear cells, platelets and zoledronic acid for the clinical prevention of~     collapse of the early-stage osteonecrotic femoral head.~   "
64561|NCT02721927|"~     Since the beginning of the Syria conflict in March 2011, more than 10 million Syrians were~     forced to leave their homes and sought refuge in neighboring countries.~   "
64562|NCT02721914|"~     The main goal of this study is to get to know if applying both, massotherapy plus~     hypopressive abdominal gymnastics (H.A.G) will reduce the pain of chronic non-specific low~     back pain. It actually reduces the inability produced by the pain and improve the patient's~     quality of life as well as the join range of the lumbar spine, way more than these two~     therapies applied separately.~   "
64563|NCT02721901|"~     The purpose of this study is to further develop the integrated Eating Aversion Treatment~     (iEAT) manual, which is designed to address chronic food aversion in children with chronic~     food refusal. This study will evaluate the feasibility and efficacy of the iEAT manual when~     it is used in the home home environment with caregivers.~   "
64564|NCT02721888|"~     Non-alcoholic fatty liver disease (NAFLD) is commonly associated with obesity, metabolic~     syndrome and type 2 diabetes. NAFLD, in patients with type 2 diabetes, has been shown to be~     associated with lipid abnormalities (such as hypertriglyceridemia and decreased~     HDL-cholesterol) and increased cardiovascular risk. Such lipid abnormalities~     (hypertriglyceridemia and decreased HDL-cholesterol) are very frequent in patients with type~     2 diabetes. Moreover, NAFLD is a risk for further development of cirrhosis (estimated between~     3 and 5%).~      Animal studies have shown that liraglutide is able to decrease liver fat content, but the~     effect of liraglutide on liver fat content in patients with diabetes remains unknown.~      In addition, human studies with liraglutide have shown significant modification of plasma~     lipids, such as reduction of plasma triglycerides and LDL-cholesterol. However, the~     mechanisms responsible for these liraglutide induced lipid modifications are not yet known.~      Because increased in liver fat content and hypertriglyceridemia are associated in patients~     with type 2 diabetes, it seems interesting to study the effect of liraglutide on both liver~     fat content and lipid metabolism using gold-standard methods (proton-spectroscopy for liver~     fat content assessment and kinetic study with stable isotope to study lipoprotein~     metabolism).~      This is a monocentric study. Fatty liver content will be performed by proton-spectroscopy in~     patients with type 2 diabetes (n=120) before and after a 6 month period of liraglutide~     therapy (1.2 mg/day).~      Moreover, an in vivo kinetic study will be performed with stable isotopes (13C leucine) in 10~     patients among the 120 patients with type 2 diabetes (n=10) before and after a 6-month period~     of liraglutide (1.2 mg/day) therapy. Each kinetic study will be performed during a 2-day~     hospitalization~      For the main study, 3 visits will be performed:~        -  a first visit at T0, before starting the treatment with liraglutide, including clinical~          and biological measurements and liver fat content assessment by proton-spectroscopy~        -  a visit at 3 months including clinical and biological measurements~        -  and a visit at 6 months including clinical and biological measurements and liver fat~          content assessment by proton-spectroscopy~      For the kinetic substudy, performed in 10 patients, a kinetic study with stable isotope will~     been performs during a 48h-hospitalization before starting the treatment with liraglutide and~     after 6 month-treatment with liraglutide~   "
64565|NCT02721875|"~     The objectives of this trial are to evaluate the safety, tolerability, maximum tolerated dose~     (MTD), pharmacokinetics and preliminary efficacy of volasertib in two dosing schedules of~     intravenous volasertib as monotherapy or in combination with azacitidine in patients with~     myelodysplastic syndrome (MDS) after hypomethylating agents (HMA) treatment failure.~   "
64566|NCT02721862|"~     This is a randomized double-blind placebo-controlled trial with a total of 100 patients who~     are free of gallstones at baseline. The study involves taking an oral drug (Ursodeoxycholic~     Acid 250mg) or a placebo twice daily for a period of six months and undergoing a total of~     three abdominal ultrasounds (at 6 months, at 12 months, and at 18 months) to check for~     gallstones.~   "
64567|NCT02721849|"~     A randomized controlled trial to investigate the efficacy of yoga on tension type headache~     and / or migraine in adolescents between 12 and 16 years, consisting of a four group design~     which includes an 12 week yoga course and a three-month follow-up period. Both adolescent and~     one parent will be randomized either to yoga or no treatment. Primary outcome will be pain~     frequency in adolescents considering pain catastrophizing of parents.~   "
64568|NCT02721836|"~     The proposed study aims to investigate the feasibility, effectiveness, and perceived benefit~     of a hatha yoga intervention for patients with irritable bowel syndrome (IBS) compared to~     nutrition counselling. Further, the potential of both interventions to influence the gut~     microbiome will be inquired.~   "
64569|NCT02721823|"~     Patients with ulcerative colitis often suffer significant limitations to their quality of~     life, which are also conditioned by particular stress and psychosocial accompanying symptoms~     of the disease. A multimodal program for stress-reduction and lifestyle-modification has been~     shown to be effective in promoting the quality of life. The study will examine the promotion~     of the quality of life of patients with ulcerative colitis and the positive Influence on~     stress, psychological symptoms and physiological parameters. 92 patients with ulcerative~     colitis will be randomized in an Intervention group and a control group for 10 weeks. The~     primary outcome is the disease-specific quality of life, the secondary outcomes are stress,~     psychological symptoms, inflammatory parameters, disease activity parameters, bowel parameter~     and the microbiome.~   "
64681|NCT02720354|"~     [11C]-dimethyl-diphenyl ammonium ([11C]-DMDPA) - A Phase I, Open‑label, Safety and~     Tolerability, Radiation Dosimetry, Biodistribution, First‑in-Human Study of a Novel~     11C‑labeled Tracer for Positron Emission Tomography Myocardial Perfusion Imaging~   "
64570|NCT02721810|"~     A no-cost intervention may improve adherence with a recommendation for higher-quality,~     lower-cost care for patients with critical illness endorsed by a collaborative of critical~     care societies. The investigators propose prompting consideration of functional outcomes.~     This trial will help establish the impact of the intervention on practice patterns including~     proxy engagement and elements of shared decision-making.~   "
64571|NCT02721797|"~     Ehlers-Danlos Syndrome (EDS) is an inherited disease of collagen, found in connective~     tissues, such as skin. EDS patients suffer from joint and skin problems (skin~     hyperextensibility, joint hypermobility) along with a large range of other disorders,~     including, delayed wound healing with atrophic scarring, easy bruising, tissue fragility,~     gastrointestinal and gum problems. There are many different types of EDS, with different~     mechanisms of action, and not all of these are well understood. This study will used advanced~     microscopy techniques called atomic force microscopy (AFM) and scanning electron microscopy~     (SEM) to analyse the changes in collagen as a result of EDS, compared to normal collagen.~     These changes will be viewed at the micron and nanoscale level (between 1,000 to 100,000 x~     magnification), and will focus on the differences in collagen construction through a process~     called cross-linking. These changes could potentially help clinicians understand the root~     cause of EDS symptoms, and provide a deeper knowledge of cross-linking disorders in collagen.~     Increasing our knowledge of how collagen is affected in EDS patients, may lead to improved~     treatment options for patients.~   "
64572|NCT02721784|"~     The evaluation of the radiological changes in localised or locally advanced prostate cancer~     after androgen deprivation therapy and external beam radiotherapy using multi-parametric MRI~     (multi parametric magnetic resonance imaging) and VERDICT (Vascular, Extracellular and~     Restricted Diffusion for Cytometry in Tumours) sequences.~   "
64573|NCT02721771|"~     Preeclampsia remains a leading cause of maternal morbidity and mortality, in both the~     developed and developing world. It is a complex, multisystem disease which, in its severe~     form, affects the cardiovascular, renal, hepatic, neurological and haematological systems.~     The University of Cape Town-associated medical institutions alone were responsible for the~     treatment of 800 women in 2014, who were classified as having preeclampsia with severe~     features. Given the complexity of the disease, anesthetic management for Caesarean section in~     these patients remains very challenging.~      Recent studies have begun to demonstrate novel markers of preeclampsia severity, including~     point-of-care ultrasound (POC-US) and acid-base (AB) abnormalities. For example, pilot~     studies have demonstrated that approximately 25% of women diagnosed with severe preeclampsia~     show signs of increased intracranial pressure and elevated lung water as evaluated by point~     of care ultrasound. These findings could serve as noninvasive markers of disease severity,~     and thus may be used to predict maternal and fetal outcome in preeclamptic women. Point of~     care ultrasound is playing an increasing role in perioperative diagnosis, and newer, less~     expensive devices are continuously being developed, and will in all likelihood play an~     important role in South Africa in the near future.~      In a recent trial performed at the University of Cape Town, a comprehensive acid-base~     analysis in severe preeclamptic women demonstrated significant abnormalities in independent~     acid-base determinants. In addition, strong indications were found that changes in acid-base~     status in preeclampsia are more pronounced earlier in pregnancy and are associated with~     urgent deliveries. As in other clinical arenas in critically ill patients, acid-base~     abnormalities are associated with increased lung water, increased intracranial pressure, and~     outcome, and we hypothesize that similar associations might be found in severe preeclamptic~     women. Therefore, one aim of this study is to evaluate the association of venous acid base~     abnormalities (an inexpensive and readily available test) observed in late onset severe~     preeclampsia and organ manifestations identified with ultrasound, a well-validated and robust~     tool for identifying these manifestations. Investigators will further examine the association~     between ultrasound findings and/or venous acid-base abnormalities with urgent delivery. It is~     intended to do a subsequent comparison between early- and late onset preeclampsia, when a~     suitable tertiary site has been identified.~   "
64574|NCT02721758|"~     The purpose of this study was to test whether a brief motivational intervention is associated~     with enrollment in cardiac rehabilitation.~   "
64575|NCT02721745|"~     While the scientific community understands quite well why muscles ache after prolonged~     exercise, the origins of mental fatigue remain totally mysterious. Existing theories remain~     at a psychological level, with scarce supporting evidence. Mental fatigue typically occurs~     after long episodes during which humans exert control on motor or cognitive processes,~     instead of executing routine or stimulus-driven behaviours. However, work organization~     (especially in risky job like airplane control or medical profession) and pathologies due to~     an overload of work (like burn-out) seems to be directly linked to neural fatigue. One of the~     consequences of neural fatigue is to alter decision-making. As an example, the choice between~     an immediate monetary reward and a larger but delayed monetary reward (the so called~     intertemporal choices) are susceptible to fatigue state of its underpinning neural network.~      The investigators are proposing an exploratory study of neural fatigue, induced either in a~     natural way (by performing cognitive tasks for hours) or by transcranial stimulation, using~     three main physiological measures (Electro-encephalography to measure neural activity,~     indirect calorimetry to measure the metabolic cost of a cognitive effort, and pupillometry to~     measure cognitive effort).~      This study should allow to better understand the consequences of neural fatigue on cognitive~     functions like decision making as well as the associated physiological variables.~   "
64576|NCT02721732|"~     The goal of this clinical research study is to learn if pembrolizumab (also called MK-3475)~     can help control the disease in patients with advanced cancer.~      This is an investigational study. Pembrolizumab is FDA approved for the treatment of certain~     types of melanoma and non-small cell lung cancer, however it has not been approved for~     advanced cancer. In this study it is being used for research purposes only. The study doctor~     can explain how the study drug is designed to work.~      Up to 250 participants will be enrolled in this study. All will take part at MD Anderson.~   "
64585|NCT02721615|"~     About a thousand people a year in the United Kingdom survive a spinal cord injury but are~     left paralysed or wheelchair-bound. The annual cost of care for spinal cord injury victims is~     more than half a billion pounds. We propose that after spinal cord injury, cord pressure at~     the injury site rises, damaging the spinal cord further by secondary ischaemia. The value of~     measuring and reducing cord pressure after spinal cord injury is unknown.~      The injured spinal cord is compressed by bone malalignment and cord swelling. Current~     management involves realigning and fixing the bony fragments using metal screws, rods and~     plates. We hypothesise that: 1. Bony realignment alone does not adequately decompress the~     swollen cord, which remains compressed against the surrounding dura. 2. That duraplasty~     reduces intra spinal pressure more effectively than bone realignment alone. 3. Localised~     hypothermia reduces intra spinal pressure and improves metabolism.~      We will develop a novel method to measure cord pressure and metabolism at the injury site~     after spinal cord injury and determine whether the cord pressure rises, for how long, and~     with what impact on spinal cord metabolism.~      This is a pilot study to find out whether spinal cord pressure and metabolism can be measured~     after spinal cord injury and whether they are effected by treatment choices.~   "
64577|NCT02721719|"~     The cause of Inflammatory Bowl Disease (IBD) is not known, but studies from patients with IBD~     have found that these patients make unusually strong immune responses to their own intestinal~     tissues and to bacteria that normally live in the healthy gut. These overactive immune~     responses might result from an imbalance of T-lymphocytes, which are a type of white blood~     cell that recognize and respond to threats like infection or damaged tissues. In healthy~     tissues, a type of T-lymphocytes called T-regulatory cells control excess inflammation by~     preventing other T cells, called T-effector cells from responding. We believe that~     T-regulatory cells are somehow less active in IBD, resulting in damage to intestinal tissues~     by the T-effector cells.~      T-lymphocytes, including both T-regulatory and T-effector cells, are guided to different~     parts of the body by 'alpha4beta7-integrin' molecules. Vedolizumab or Entyvio works by~     blocking this homing molecule so that T cells do not reach the intestine, but stay in the~     blood where they cannot aggravate your IBD. This study will help in understanding how~     Vedolizumab helps to heal or decrease the symptoms of your Ulcerative Colitis.~      The effect of Vedolizumab on different types of T cells in the human intestine has not yet~     been studied. However, the investigators think that Vedolizumab will shift the balance of T~     cells in the intestine towards more healing T-regulatory cells and less damaging T-effector~     cells. The purpose of this study is to measure the different types of T cells in~     participants' blood and intestinal tissue before and during Vedolizumab treatment.~   "
64578|NCT02721706|"~     Objectives: To evaluate the cost-effectiveness of implementing a malnutrition screening tool~     CIPA at the Hospital Universitario Nuestra Señora de la Candelaria (HUNSC), comparing the~     impact on health and the healthcare costs of hospitalised patients who are screened for~     malnutrition and of patients following standard clinical practice. Methodology: The study~     will consist of a controlled trial on patients admitted to the Internal Medicine and General~     and Digestive Surgery wards at the HUNSC. In both wards patients will be assigned to a~     control or to an intervention group. The control group will follow usual hospital clinical~     care, while the intervention group will be administered the screening tool CIPA for early~     detection of malnutrition cases and they will be treated according to the screening results.~     The following variables will be evaluated: length of stay in hospital, mortality,~     readmissions and in-hospital complications. Cost-effectiveness analysis will be undertaken~     measuring effectiveness by Quality-Adjusted Life Years (QALYs). Cost per patient will be~     measured by identifying health care resource utilisation, and the cost-effectiveness measure~     will be the Incremental Cost-Effectiveness Ratio (ICER). Investigators will calculate the~     incremental cost per QALY gained related to the intervention. This analysis will allow to~     quantify the costs (incurred and saved) related to the introduction of the malnutrition~     screening tool CIPA in the hospital context and to measure the health impact of screened~     patients.~   "
64579|NCT02721693|"~     The primary purpose of the study is to investigate if physical exercise is associated with~     myocardial damage, expressed by elevated troponin T, in patients with COPD.~   "
64580|NCT02721680|"~     The goal of the proposed project is to provide the Army with a brief, well-validated,~     internet-based training program for enhancing Awareness Training and resilience skills. This~     project will address the needs outlined for the Military Operational Medicine Research~     Program, particularly with regard to enhancing Psychological Health and Resilience. The~     fundamental approach of the project directly addresses the need to develop psychological~     resilience among Service members and families to promote well-being and prevent behavioral~     health outcomes. Addressing this need is crucial, as military personnel are often required~     to serve under dangerous and emotionally stressful conditions. Prolonged stress or exposure~     to very intense life threatening experiences, such as those encountered in combat or other~     hazardous duty deployments can increase the risk of developing mental health problems~     including depression, anxiety, or post-traumatic stress disorder (PTSD). One possible way to~     minimize the effects of these stressful experiences on Service members is to strengthen their~     emotional flexibility, adaptability, and capacity to cope with adversity before they find~     themselves faced with such situations. To fill this need, the investigators propose to~     provide the military with a web-based program that focuses on enhancing Awareness Training, a~     core set of trainable awareness skills that collectively include the capacity to understand,~     perceive, control, and use emotions effectively.~      While the previous pilot program was successful in some ways, it needs further research~     before it is ready for widespread use. The investigators therefore propose to build upon the~     existing strengths already in the program and redesign the weaker modules to be more~     effective. Over the course of a four-year study, the investigators propose to develop this~     program. The proposed Awareness Training program is brief, web-based, easily accessible, and~     sufficiently focused such that it could be completed by large numbers of military personnel~     with minimal time burden, leading to rapid enhancement of awareness skills. Such a program~     could have a significant effect in promoting resilience, interpersonal functioning, and brain~     health among Service members and their families, while reducing the likelihood of mental~     health problems among those returning from exposure to potentially traumatic experiences.~      The central hypothesis is that a set of well designed and targeted training modules~     addressing core awareness ability domains will significantly enhance measured awareness~     skills, will translate into improved performance on militarily relevant metrics, and will~     lead to better mental and emotional health, as well as well being during stressful situations~     and subsequent cognitive processing.~   "
64581|NCT02721667|"~     Hypertension affects over 70% of Canadians over the age of 65y. Seniors with hypertension are~     at high risk for cardiovascular disease and death. Most of this risk is mediated through high~     blood pressure (BP). However, seniors are also at risk for side effects from BP lowering~     medication. These can be life threatening and costly. Therefore, BP monitoring is required to~     ensure BP levels are in the recommended range (neither too high nor low).~      Home BP monitoring can be used to ensure that BP is in the right range and is recommended for~     all patients with high BP. Studies in other health care systems show that, to optimally~     perform home monitoring, the readings should be teletransmitted (electronically sent to the~     care provider). Additional studies indicate that BP control improves when health care~     providers (usually pharmacists or nurses) are specifically assigned to review teletransmitted~     BP readings and, using protocols, make therapeutic adjustments. However, a study needs to be~     conducted within the Canadian healthcare system to prove that telemonitoring±case management~     is cost-effective. In addition, proof that seniors consider telemonitoring to be usable and~     acceptable is required.~      The investigators will conduct a 200 patient randomized trial in community-dwelling seniors~     that will compare home BP monitoring alone to telemonitoring plus case management, to~     comprehensively assess cost-effectiveness, usability, and acceptability. Our partners include~     TeleMED, a medium sized Canadian technology company with a wealth of experience in medical~     data management and transmission; Pharmacare, which will provide case-management services.~     The study will take place in seniors' supportive living residences; by virtue of residing in~     these institutions, these seniors have complex care needs. This intervention, if effective,~     cost-effective and safe, can be widely implemented.~   "
64582|NCT02721654|"~     The aim of PLUS is to conduct a multi-centre, blinded, randomised, controlled trial (RCT) to~     determine whether fluid resuscitation and therapy with a balanced crystalloid solution~     (Plasma-Lyte 148®) decreases 90-day mortality in critically ill patients requiring fluid~     resuscitation when compared with the same treatment using 0.9% sodium chloride (saline)~   "
64583|NCT02721641|"~     This study is designed to provide continued access to intravenous (IV) Herceptin and to~     evaluate long-term outcomes and overall safety in participants with stable disease and human~     epidermal growth factor 2 (HER2)-overexpressing metastatic or locally advanced cancer who~     have completed a prior study with IV Herceptin.~   "
64584|NCT02721628|"~     Epi-keratoplasty Versus Collagen Cross-Linking in Progressive Keratoconus~   "
64586|NCT02721602|"~     The current study proposes to study the feasibility and acceptability of the Families~     Preventing Diabetes Together Intervention among 40 families who have one parent diagnosed~     with type 2 diabetes and at least 1 child between the ages of 5-14 years of age. Successful~     recruitment, measurement and randomization of patients and their families will provide data~     for our aim of assessing feasibility. Patient and family participation in the intervention~     and feedback via the post-intervention surveys will provide data for our aim of~     acceptability.~   "
64587|NCT02721589|"~     This is an open-label, single center, non-randomized, dose escalation phase I trial to~     evaluate safety and tolerability of SHR-1210 in patients with advanced solid tumors The~     primary objective is to assess safety and tolerability of SHR-1210 and identify recommended~     phase II doses of SHR-1210 in patients with advanced solid tumors~   "
64588|NCT02721576|"~     This is a perspective, multicenter,single arm, open label, Phase 2 study to evaluate the~     efficacy and safety of treatment with CMNa combined with concurrent chemoradiotherapy in~     patients with locally recurrent squamous cell esophageal carcinoma . Analyses of primary~     objective (ORR) will be done as defined in the protocol.~   "
64589|NCT02721563|"~     This is a perspective, multicenter,randomized controlledtrial,Phase 2 study to evaluate the~     efficacy and safety of treatment with CMNa combined with concurrent chemoradiotherapy in~     patients with locally advanced squamous cell esophageal carcinoma . Analyses of primary~     objective (ORR) will be done as defined in the protocol.~   "
64590|NCT02721550|"~     This is a perspective, multicenter,single arm, open label, Phase 2 study to evaluate the~     efficacy and safety of treatment with CMNa combined with preoperatie concurrent~     chemoradiotherapy in patients with locally advanced squamous cell esophageal carcinoma .~     Analyses of primary objective (pathologic Complete Response) will be done as defined in the~     protocol.~   "
64591|NCT02721537|"~     Can nicotinamide riboside (750 mg/day for 12 weeks) affect the levels of NAD+ in the brain as~     measured by 31P MRS?~   "
64592|NCT02721524|"~     This study aims to compare whether De Vega's Suture annuloplasty is equally effective in~     reducing the progression of Functional Tricuspid regurgitation as that claimed for Ring~     annuloplasty in Rheumatic Heart Disease patients with concurrent Mitral valve replacement.~   "
64593|NCT02721511|"~     This is a, prospective, single center, open-label, pilot study to evaluate the safety and~     efficacy of the subcutaneous administration of a novel furosemide formulation. The results of~     this pilot study will be reviewed to determine the safety of the subcutaneous treatment~     regimen and to evaluate patient selection criteria for possible at home treatment. The intent~     is to conduct a future follow on study looking at the feasibility of at home treatment of~     patients referred to a hospital for treatment of fluid overload.~   "
64594|NCT02721498|"~     This is a randomised controlled cross-over trial involving adult cystic fibrosis (CF)~     patients from the Royal Brompton Hospital, London investigating outcome measures used in~     airway clearance trials.~      Each participant will attend the research facility for two visits. Participants will be~     randomly assigned to the order that they perform the study sessions. Visit A will involve a~     period of rest for up to 60 minutes in-between assessments; Visit B will involve a session of~     airway clearance (ACT) utilising ACBT supervised by a specialist physiotherapist in adult CF.~      Participants will perform the outcome measure (OM) tests of impulse oscillation system (IOS),~     lung clearance index (LCI), and spirometry, then either rest (visit A) or perform a~     supervised ACBT session (visit B) using electronic impedance tomography (EIT) during the~     session. IOS, LCI and spirometry will be repeated after the session. Sputum will be collected~     throughout the ACT or rest sessions and for 30 minutes after each of these sessions is~     completed. Questionnaires asking patient views on the OMs will be completed at the end of~     each study visit.~      Analysis will be based upon differences in outcome measures and in-between study days.~   "
64595|NCT02721485|"~     Salt fluids are used extensively for acutely ill patients who are admitted to hospital. Two~     salt fluids commonly used are Normal Saline and Ringer's Lactate. Both are used to rehydrate~     patients, restore fluid volume and help stabilize blood pressure and failing organs. Both~     salt fluids have been used for several decades. Until recently, it was thought the fluids are~     essentially equivalent other than some minor differences related to the concentration of salt~     components (sodium and chloride) and buffers (Ringer's Lactate has lactate as a buffer).~     Recent data suggest that salt fluids containing less chloride like the Ringer's Lactate,~     cause less acid in the blood, less kidney failure, and less death. However, the studies to~     date are small and weak in their design and it is possible that there are no important~     differences that affect patients. Hence, the research team will conduct a robust pragmatic~     clinical trial where several academic and community hospitals will be randomized to use~     either Ringer's Lactate only or Normal Saline only for a period of three months. The trial~     will yield high quality and robust data to determine if Ringers Lactate reduces death and~     re-admissions to hospital. Before embarking on this large-scale trial, it is important to~     conduct a smaller (pilot) trial to evaluate if the larger trial will be feasible and not too~     costly. In this small trial involving no less than 4 hospitals, the investigators will~     determine how well the fluid interventions are adhered to in each hospital, record how long~     it takes to receive approval from research ethics boards and be ready to start the study. The~     investigators will also record challenges and develop solutions related to the operations of~     the trial, and describe important clinical and outcome data essential for the design and~     planning of the large trial.~   "
64596|NCT02721472|"~     The purpose of this study is to evaluate the relationship between plasma DNA levels and~     micro- and macro-circulatory vascular remodelling in patients with sickle cell disease~   "
64597|NCT02721459|"~     The main purpose of this study is to determine the maximum tolerated dose (MTD) and~     recommended phase II dose (RP2D) of XL888 when administered orally with vemurafenib plus~     cobimetinib in participants with BRAF V600 mutated melanoma and to evaluate the safety and~     tolerability of this combination.~   "
64598|NCT02721446|"~     The purpose of this study is to find out which types of written stroke messages may help high~     risk stroke patients take action to improve their health.~   "
64682|NCT02720341|"~     Consideration-of-Concept Trial (stage 1) on robotic therapy of the upper extremity with the~     ARMin therapy robot in healthy subjects and patients with neurological disease (e.g. stroke,~     spinal cord injury)~   "
64599|NCT02721433|"~     The current Rethinking Clinical Trials (REaCT) trial will compare two schedules(12- vs.~     4-weekly) of bone-targeting agents (BTAs) to evaluate quality of life, pain and skeletal~     events within the Canadian Health Care System. This study will use an integrated consent~     model that involves oral consent rather than a written informed consent writing process as~     the study is comparing standard schedules and not a new administration schedule.~   "
64600|NCT02721420|"~     Background and rationale: Children hospitalised with severe anaemia in Africa are at high~     risk of readmission or death within 6 months after discharge. No strategy specifically~     addresses this post-discharge period. In Malawi, 3 months of post-discharge malaria~     chemoprevention (PMC) with monthly 3-day treatment courses of artemether-lumefantrine (AL) in~     children with severe malarial anaemia prevented 31% of deaths and readmissions. The effect~     was in addition to the effect of insecticide-treated bednets. There is now need to design and~     evaluate effective delivery mechanism for PMC within the health system.~   "
64601|NCT02721407|"~     The goal of this clinical trial is to study the feasibility and efficacy of~     anti-CD22:TCRz:4-1BB chimeric antigen receptor (CAR)-modified T (CAR-T) cells in treating~     recurrent patients with refractory or resistant lymphoma to anti-CD19:TCRz:CD28 CAR-T cells.~     Recently, cancer immunotherapy, treatments aiming to arm patients with immunity specifically~     against cancer cells, has emerged as a promising therapeutic strategy. Among the many~     emerging immunotherapeutic approaches, clinical trials utilizing CARs against B cell~     malignancies have demonstrated remarkable potential. CARs combine the variable region of an~     antibody with T-cell signaling moieties to confer T-cell activation with the targeting~     specificity of an antibody. Thus, CARs are not MHC-restricted so they are not vulnerable to~     MHC down regulation by tumors. However, defined by the recession of evaluable lesions, the~     persistence and efficacy of CAR-T cells are still restricted by the target selection.~     Previous clinical studies largely utilized CD19 for the in vivo targeting of CAR-T cells,~     which preferentially become refractory or resistant due to the heterogeneity of lymphoma.~     This clinical investigation is to test a hypothesis whether anti-CD22 CAR-T cells work more~     effective in lymphoma patients refractory or resistent to anti-CD19:TCRz:CD28 CAR-T cells.~   "
64602|NCT02721394|"~     The current project aims to assess the feasibility of conducting Functional Communication~     Training in the UK with a small sample of young children (aged under 9) in an NHS setting.~     Three delivery formats will be assessed in order to demonstrate the feasibility of conducting~     FCT via different delivery methods within an NHS context. Participants will be four children~     aged under 9 who have an identified intellectual / developmental disability and display~     either self-injury, property destruction, or aggression at home. In addition, one family~     carer per child will be coached to implement the intervention, either following researcher~     intervention, or from the beginning. Data will be collected on challenging behaviour,~     communication responses, family carer confidence in managing behaviour, fidelity of~     intervention implementation, family quality of life, and acceptability of the intervention.~   "
64603|NCT02721381|"~     The specific objectives of this project are to conduct a randomized control trial to examine~     the effect of a novel, telehealth parent training intervention for children with autism~     spectrum disorder (ASD), ImPACT Online, on parent and child outcomes. The investigators will~     compare the benefits of the self-directed and therapist-assisted delivery formats, and~     examine moderators and mediators of treatment outcomes. The investigators anticipate that~     both the self-directed and therapist-assisted models of ImPACT Online will be effective~     methods for teaching parents to use evidence-based intervention strategies and for increasing~     parent self-efficacy compared to a web-based information control group. Participants will be~     randomly assigned to one of three groups. One-third of participants will be in the~     therapist-assisted group; one-third will be in the self-directed group; and one-third will be~     in a web-based information control group.~   "
64604|NCT02721368|"~     The purpose of this study is to determine whether Neuramis® Volume Lidocaine is effective in~     the temporary restoring the mid-face volume.~   "
64605|NCT02721355|"~     H. pylori positive patient volunteers that passed the selection criteria are recruited and~     divided into a test and a control group. Both groups are treated with a current treatment~     regime (EAC: Esomeprazole 40 mg/day; Clarithromycin 1000 mg/day; Amoxicillin 2000 mg/day) but~     only the test group received IgY-containing food supplement as an adjunctive measure for 15~     days. The subjects are examined before and 4 weeks after the treatment initiation by Urea~     Breath Test (UBT) and gastro-endoscopy.~   "
64606|NCT02721342|"~     Most chronic kidney diseases have a progressive evolution characterized by the gradual loss~     of glomerular filtration rate (GFR), electrolytic imbalance, reduced erythropoietin synthesis~     and activation of vitamin D. On many occasions, the progressive deterioration of renal~     function occurs, even when the etiologic factors responsible for the kidney disease are~     treated and/or eliminated as a result of an auto-sustained mechanism of inflammation and~     fibrosis. Moreover, chronic nephropathies are often associated with high blood pressure and~     increased urine protein excretion, being both risk factors of progression toward kidney~     failure. Many clinical studies have shown the efficacy of antihypertensive therapies,~     particularly the blockade of renin-angiotensin system, to lower the abnormal urinary protein~     excretion. Moreover, control of blood pressure and proteinuria slow the rate of renal~     function decline and in some cases even lead to recovery of kidney function avoiding the need~     for renal replacement therapies. The set of measures to achieve these results encompasses the~     term of renoprotective therapy. However these achievements have been obtained in the~     setting of clinical trials, and need confirmation in the daily clinical practice.~      To this purpose a standardized multidrug intervention model that aims at normalizing the~     excretion of urinary proteins and stabilizing the renal function has been developed for the~     outpatient-clinic and named Remission Clinic.~      The applicability of this protocol is aimed for all nephrology and diabetology centers.~     Through the use of a dedicated database computer network, it will be possible to share~     clinical, laboratory and treatment data, recorded for each patient enrolled in the Remission~     Clinic program. With this system, it will be possible to verify if the multidrug approach of~     the Remission Clinic will allow to improve the clinical course of chronic proteinuric~     nephropathy. All participants (centers) may access to the Remission Clinic website developed,~     updated and maintained by the Department of Bioengineering of the Mario Negri Institute,~     Bergamo, Italy.~   "
64607|NCT02721329|"~     The hypothesis is that APAP with SensAwake improves wake-after sleep onset compared to APAP~     without SensAwake in a patient population with Obstructive Sleep Apnea Syndrome (OSAS) and~     Insomnia.~   "
64608|NCT02721316|"~     To evaluate the impact of a specific nursing management (personalized and close, through~     consultation at the hospital, at home or by phone) monitoring in post-hospitalization, the~     suicide attempt of recurrence and suicidal crisis, in the year following a suicide attempt in~     patients suffering from a mood disorder (unipolar or bipolar) or reactive depression.~   "
64609|NCT02721303|"~     This study plans to learn more about how age and weight impact appetite and food intake.~     Specifically, this study is being done to see whether age and obesity impact appetite and the~     brain's response to food. In this study the investigators will be evaluating how participants~     brains respond to food images as well as your food-related behaviors and hormones. The~     investigators will be comparing older individuals aged 65 to 85 years who are normal weight~     compared to those who are obese. The Investigators will then compare older aged individuals~     to younger adults aged 21 to 45 years.~   "
64610|NCT02721290|"~     In this study, we will be comparing two approaches to the femoral block. The first or~     classical approach and one that is the most popular in our institution is used by combining~     ultrasound guidance and neurostimulator to do the block. The second is performed with the~     ultrasound alone aiming at the inferolateral aspect of the femoral artery with the needle and~     injecting. The primary endpoint of the study is the sensitive cutaneous block distribution~     using both techniques.~   "
64611|NCT02721277|"~     Parenteral nutrition (PN) provides intravenous nutritional supplementation for infants unable~     to absorb adequate enteral nutrients secondary to insufficient intestinal length or function.~     In early PN-associated cholestasis, the dose of traditional soy based lipid is limited to 1~     g/kg/day which often limits the growth capacity of parenteral nutrition-dependent infants.~     Inadequate growth is directly related to poor neurological outcomes, failure to facilitate~     mechanical ventilation, and less growth of the neonate's already damaged intestine.~     Ultimately, these outcomes can lead to severe disability and death. To mitigate these~     deleterious effects and optimize growth, parenteral nutrition-dependent infants with~     cholestasis who are not adequately growing on 1 g/kg/day of soy-based lipid emulsion must~     have a greater intake of lipids to meet their needs for weight, length, and head~     circumference growth.~      SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides~     essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less~     susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain~     triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish~     oil which provides the supply of omega-3 fatty acids. The utility of Omegaven and soy-based~     lipid emulsion is limited as these are restricted to 1 g/kg/day in cholestatic infants.~     SMOFlipid is safe to be provided at the usual goal infusion amount of 3 g/kg/day. Because~     this product includes both omega-6 and omega-3 lipids, it provides the benefits of the~     omega-3s for the liver and provides more than enough omega-6s to meet essential fatty acid~     requirements. Its use in situations in which growth is inadequate in babies who must be~     restricted to 1 g/kg/day can be expected to improve their growth and likely markedly increase~     their chances of both a good neurological outcome and survival.~      The aim of this research study is to determine if the unique formulation of SMOFLipid will~     cause less hepatic inflammation compared to soy only intralipids.~   "
64612|NCT02721264|"~     Patients of NASH (Non Alcoholic Steatohepatitis) cirrhosis with current or prior histological~     evidence of steatosis or steatohepatitis admitted under the Department of Hepatology at~     Institute of Liver and Biliary Sciences, who meet the inclusion criteria and who provide~     informed consent will be included in the study.~   "
64613|NCT02721251|"~     Obstructive sleep apnea (OSA) is highly prevalent among Veterans, and is associated with~     significant mortality and multiple morbidities. Available treatments have had limited~     effectiveness in treating OSA and alleviating associated morbidity. The investigators'~     previous research found a reduction in OSA severity of approximately 25% following modest~     exercise training. That this effect occurred independent of weight loss raises the exciting~     possibility that exercise combined with weight loss could reduce OSA by at least 50% and have~     unique health benefits for OSA patients. Following screening and baseline assessments, 90~     overweight Veterans ages 18-60 years with OSA will be randomized to one of three 16-week~     treatments: (1) exercise training; (2) 10 % weight loss; and 3) exercise + weight loss.~     Changes in OSA and related morbidity will be compared between treatments.~   "
64614|NCT02721238|"~     Consecutive cirrhotics who present to emergency department of Institute of Liver & Biliary~     Sciences with documented or suspected sepsis induced hypotension will be randomized to~     receive either human albumin infusion over 3 hours or plasmalyte as per requirement. At~     admission, all patients will undergo physical examination and baseline investigations to~     identify site of sepsis. The aim of study is to compare the efficacy of using 20% human~     albumin versus plasmalyte in resuscitation of the patient that is attainment of mean arterial~     pressure above 65 mm of Hg at three hour after intervention and sustenance of mean arterial~     pressure above 65 mm of Hg at 6th hour. The randomized patient will be administered 20%~     albumin (0.5-1.0 gm/kg) for 3 hours, or plasmalyte at the rate of 30ml/kg. After the~     intervention changes in MAP (Mean Arterial Pressure), lactate level, urine output, incidence~     of complications, duration of ventilator, ICU (Intensive Care Unit) stay and mortality after~     one week will be studied.~   "
64615|NCT02721225|"~     More than 20 million infants worldwide, representing 16 per cent of all births, are born with~     low birth weight, 96 per cent of them in developing countries. Bangladesh having one of the~     highest incidence rate (21.6%) in the world.The short-term consequences of LBW is 12 times~     higher perinatal mortality. It is estimated that LBW causes 60 to 80 % of neonatal deaths.~     For the survivors, the effects are long lasting and largely irreversible. Infants born LBW~     are at 2-4 times greater risk to develop acute diarrhea, pneumonia or acute respiratory tract~     infection than their normal birth weight counterparts. Adults born with LBW suffer increased~     risk of high blood pressure, coronary heart disease (CHD), non insulin dependent diabetes~     mellitus, obstructive lung diseases, or renal damage.~      Genitourinary (GU) infection, as a major risk factor for low birth weight deliveries~     affecting a very large number of women both in the industrialized and the developing world.~     In Bangladesh, there was a high incidence of UTI in 21-25 years age group (44.61%). The~     bottom line for GU infection is that lactobacilli, healthy bacteria lose their dominant.~     Recently, the protective role of the commensal microbiota has come into focus for its~     infection-inhibiting function. Lactobacilli that colonize the gastrointestinal tract or~     vagina can either significantly modulate the colonic microbiota by increasing the number of~     specific prebiotic bacteria such as lactobacilli and bifidobacteria or reducing undesired~     intestinal colonization of pathogenic bacteria. Prebiotic like Fructooligosaccharide (FOS) is~     known to promote growth of normal healthy flora like lactobacilli (LAB). FOS supplementation~     in early pregnancy improves vaginal or gut microflora with LAB , which will control GU~     infection and improve pregnancy outcome and promote infant's growth and development~   "
64616|NCT02721212|"~     54 inpatients participants were randomly divided into two groups (experimental and~     conventional). Individual of experimental group were treated according to an established~     protocol for ARMEO Spring (30 minutes/session with Armeo Spring and 30 minutes/session with~     conventional treatment 5 days/week for 6 weeks). The conventional treatment consists of~     passive and active assisted mobilization of the upper limbs, traditional training based on~     the Bobath concept. Inpatients of control group were treated with conventional treatment with~     training session of 60 minutes 5 days/week for 6 weeks. All patients were evaluated by a~     blinded observer using the outcomes tests at enrollment (T0), after the treatment (T1) and at~     follow up 6 weeks later (T2). We assessed the impact on functional recovery (Functional~     Independence Measure - FIM scale), strength (ARM Motricity Index-MI), spasticity (Modified~     Ashworth Scale-MAS) and pain (Numeric Rating Pain Scale -NRPS).~   "
79421|NCT02527382|"~     The purpose of this study is to check if there is a difference in peritoneal contamination in~     patients undergoing rectal resection with closed and open rectal stump prior to anastomosing.~   "
64617|NCT02721199|"~     Acute exacerbations of COPD contribute to significant morbidity and mortality in the United~     Kingdom (UK). The ability to assess response to treatment during exacerbations that require~     hospitalisation would allow clinicians to better risk stratify patients for higher or lower~     level in-patient or out-patient care. Current methods of detecting clinical deterioration are~     validated in general medical populations and may lack sensitivity and specificity in patients~     with respiratory morbidity. The use of respiratory muscle EMG to assess neural respiratory~     drive (NRD) has been demonstrated to be a predictor of readmission in patients admitted to~     hospital with COPD. The technique has been applied on 'spot' readings of limited duration due~     to the need for hand analysis of the data. It has been performed by a trained clinical~     physiologist who removed any interference data and standardised the data gathered. New~     automated software allows for longer periods of observation, mostly unsupervised, and as a~     result, the NRD measurements are more likely to be affected by various sources of~     variability. The influence of clinical and physiological factors as they occur during routine~     clinical management, such as administration of bronchodilator medication, time of day of~     readings or proximity to chest physiotherapy, are not yet understood. This trial is designed~     to gather data to better understand these relationships with NRD.~   "
64618|NCT02721186|"~     The overall aim of this study is to determine the effectiveness of two rounds of mass drug~     administration (MDA) with dihydroartemisinin-piperaquine (DHAp) + single low dose (SLD)~     primaquine for reducing seasonal malaria transmission in Shehias considered hotspots on~     Unguja Island, Zanzibar.~   "
64619|NCT02721173|"~     The combination therapy of retinoid and clindamycin for acne is preferred because it targets~     multiple areas of acne pathogenesis that could not be accomplished with monotherapy, thereby~     improving outcome. Literature review reveals that till date there is no published comparative~     study assessing safety and efficacy of tazarotene plus clindamycin and adapalene plus~     clindamycin. So the present study has been designed to compare these two combination therapy~     in acne vulgaris.~   "
64620|NCT02721160|"~     The government of Burundi is implementing a new financing scheme in health centres. The~     objective is to provide additional financial compensations to health centres on the basis of~     their performance in nutrition activities: it consists in the introduction of criteria~     focusing on malnutrition prevention and care activities in the existing performance based~     financing (PBF) system.~      The general objective of this study is to assess the effects of this new financing scheme, to~     document its impact and to study the chains through which it occurred. This study will~     provide key evidence for countries with an existing PBF scheme and confronted with~     malnutrition problems on the appropriateness to extend the strategy to nutrition services. If~     this impact evaluation brings positive results, this may have implications for the global~     fight against malnutrition.~   "
64621|NCT02721147|"~     The central goal of this study is to examine the feasibility, acceptability, and preliminary~     efficacy of the IE intervention on patient and partner sexual QOL and relationship outcomes,~     and on patient psychosocial outcomes. We expect that the IE will show adequate feasibility,~     acceptability, and preliminary efficacy. Secondarily, based on the rationale that barriers~     exist that limit participation in intensive sexual QOL interventions for breast cancer~     survivors, an innovative secondary aim will investigate the perspectives of study-eligible~     patient candidates who opt out of participating in the pilot trial. We expect that we will be~     able to identify the participation barriers and intervention preferences of breast cancer~     survivors with sexual concerns who opt out of the intensive trial in order to inform the~     development of different interventions for future study.~   "
64622|NCT02721134|"~     Sepsis is a constant concern in ICU, frequent and severe, it requires early diagnosis and~     prompt implementation of the etiological treatment. The bacterial infections are the most~     common and are associated with high morbidity and mortality. Diagnosis is based on the~     detection of micro-organisms (bacteria) that can confirm the diagnosis and to tailor~     antibiotic treatments. Blood cultures are positive in 30-35% of cases and diagnosis is often~     based on a body of evidence that the use of biomarkers. No biomarkers (or even a combination~     of biomarkers) no evidence to confirm or refute the diagnosis of sepsis alone. During sepsis,~     gram + and gram - are circulating and often present in small amounts; they can be detected by~     sensitive and specific tools following a pretreatment of the blood sample (innovative~     technology Bacti-DIAG).~      The main objective of the multicentre study Bacti-DIAG-Rea is testing in prospectively, in a~     suspicious population resuscitation of sepsis, this new bacterial biomarker. Secondary~     objectives will assess whether Bacti-DIAG provides time and precision gain (gram + vs grams)~     in the patient's care including diagnosis and treatment.~      All ICU patients and with clinical criteria of Systemic Inflammatory Response Syndrome (SIRS)~     sepsis suspects will be included: in addition to the samples taken for routine care of the~     patient 4 tubes of whole blood will be collected 5mL. The definitive diagnosis of sepsis or~     SIRS be confirmed retrospectively by two independent experts blinded to Bacti-DIAG. The areas~     under the ROC curves for the detection of gram + and gram will be calculated and associated~     detection limits will be determined to meet the objectives of the study.~      It is planned to include 400 consecutive patients with SIRS criteria for sepsis 300-360 and~     analyze biometric and biological data based on the subsequent evolution of the patients. The~     care of patients will be blinded to the results of the new biomarker Bacti-DIAG~   "
64623|NCT02721121|"~     The purpose of this study is to compare the clinical outcomes depending on catheter ablation~     strategy for persistent atrial fibrillation. After randomization, investigators will conduct~     circumferential pulmonary vein isolation alone in a group, and additional posterior box~     isolation and anterior linear ablation in the other group. Investigators will compare~     clinical recurrence rate, complication rate, and procedure time, etc.~   "
64637|NCT02720939|"~     Specific Aims:~        1. To generate induced-pluripotent stem cells (iPSCs) from peripheral blood mononuclear~          cells (PBMCs) isolated from whole blood of ASD probands and healthy controls.~        2. To derive neural progenitor cells (NPCs) and neurons from iPSCs of ASD probands and~          healthy controls and compare differences between patients and healthy controls to~          investigate the cellular phenotype of ASD and uncover the pathophysiology of the~          disease.~   "
64638|NCT02720926|"~     Standard 3+3 dose escalation design of TKI258/XELOX in advanced gastric/gastro-oesophageal~     and colorectal cancer.~   "
64639|NCT02720913|"~     The COR-KNOT technology (LSI SOLUTIONS, Victor, New York USA) was developed to replace suture~     tying with a faster procedure during surgery. While preclinical studies confirmed the speed~     of COR-KNOT use, no clinical studies have quantitatively compared the speed of suture~     fixation delivered by the COR-KNOT device with the speed of conventional hand-tied knots.~     COR-KNOT is expensive, costing 189 $ per application. Given this added expense, it is~     important to quantify the time-saved by application of this technology.~   "
64640|NCT02720900|"~     The purpose of this study is to determine the effect of a prebiotic (BGOS) on gut microbiota~     and metabolites in children with autism spectrum disorders.~   "
64624|NCT02721108|"~     Chronic pelvic pain (CPP) in women is common, painful and disabling and puts much strain on~     women's lives and the (National Health Service) NHS.~      CPP may be related to internal organs, the nervous system or psychological factors and is~     often difficult to treat. Surgery and drugs have risks and side effects, are expensive and do~     not help all patients.~      Psychological treatments have potential to improve CPP but are not consistently available.~     Mindfulness meditation teaches people to accept their sensations and emotions in the present~     moment. This can help to accept pain better, which enables patients to focus on daily~     activities and improve their quality of life. It has been shown to help in headache, back~     pain and depression. Usually mindfulness meditation is taught by attending courses for 8~     weeks.~      The investigators want to find out in a full-scale trial if mindfulness meditation, taught by~     using a smartphone app, can help CPP patients.~      In preparation for this full-scale study the investigators will conduct the MEMPHIS study to~     answer the following questions:~        -  How many patients are willing to participate?~        -  How often they use the app?~        -  Reasons for not wanting to participate/not using the app -~           - Which health questionnaires are the most useful ones?~        -  How many patients will be required for the full-scale trial?~      Patients will receive the usual treatment and be divided into three groups~        -  using a 60-day mindfulness meditation app,~           -- using comparison app with progressive muscle relaxation but no meditation~        -  no app~      Patients will complete health questionnaires, may be asked to comment in a focus group and~     record pain, medication changes, surgery and emergency medical visits~   "
64625|NCT02721095|"~     evaluate efficacy and safety of IV administration of potassium chloride (KCl) plus 0.9%NaCl~     compare with KCl plus half-strength normal saline solution (0.45%NaCl) in correcting~     hypokalemia~   "
64626|NCT02721082|"~     The purpose of this study is to determine the impact and efficacy of a new approach to~     smoking cessation treatment versus the traditional approach.~   "
64627|NCT02721069|"~     This is a 12 month safety study to evaluate the safety of repeated doses of NRL-1~   "
64628|NCT02721056|"~     The purpose of this Phase I / II study is to evaluate the safety and preliminary efficacy of~     NBTXR3 nanoparticles given by intralesional (IL) or intraarterial (IA) injection and~     activated by Stereotactic Body Radiation Therapy in the treatment of liver cancers.~   "
64629|NCT02721043|"~     The purpose of this study is to test the safety, tolerability, and immunogenicity of~     Personalized Genomic Vaccine 001 (PGV001) in subjects with advanced non-hematologic~     malignancies. PGV001 is a peptide vaccine that is based on a patient's own tumor sequence.~     Each patient's tumor is sequenced and peptides that correspond to the tumors are made. These~     peptides combined with the adjuvant Poly-ICLC (Hiltonol®, Oncovir) make PGV001. The adjuvant~     Poly-ICLC is added to boost the immune response to the peptides and together will expand~     immune cells to target cancer.~   "
64630|NCT02721030|"~     This is a prospective cohort to describe clinical characteristics, predictors of poor~     outcomes both during hospitalization and at home, functional status, and quality of life~     among patients aged 13 years or more, consecutively admitted with acute decompensated heart~     failure at Mbarara Regional Referral Hospital.~   "
64631|NCT02721017|"~     The purpose of this study is to determine whether cryoanalgesia provides better pain control~     for minimally invasive pectus excavatum repair (the Nuss procedure) than thoracic epidural.~   "
64632|NCT02721004|"~     This is an open-label, non-interventional study to evaluate efficacy and safety in rheumatoid~     arthritis participants receiving tocilizumab as per the product label.~   "
64633|NCT02720991|"~     A pilot study on the acceptability and feasibility with Mifepristone and 400 mg of~     sub-lingual Misoprostol between 71-77 and 78-84 days of gestation for 50 cases.~   "
64634|NCT02720978|"~     Premature rupture of membranes (PROM) is a common occurrence that occurs in the incidence of~     8-10% of births. Since the duration until delivery is important in avoiding the risk of~     complications, several studies have been performed in order to understand what is the~     preferred way to manage this condition of PROM in women that are not in active labor. In the~     largest random study that has been performed 20 years ago, there was found an advantage for~     labor induction with oxytocin over labor induction with Prostaglandin or waiting. However,~     the most important component - the BISHOP score, that affects the decision of the labor~     induction way, was not reported and was not taken into consideration.~   "
64635|NCT02720965|"~     The main objective of this study is to compare the efficacy of continuous nerve blocks with~     single injection in terms of perioperative patient satisfaction after scheduled orthopedic~     ambulatory surgery. Subgroup analyses will be performed, a priori, according to patients Pain~     Catastrophizing Scale (PCS) and type of surgery.~      Secondary objectives comprise the assessment of pain, readmission rates, patient~     mobilization, quality of sleep and heart rate collected by an activity tracker. Scales about~     quality of recovery will be performed on day 1, about quality of life on day 45 and presence~     of neuropathic pain will be screened at 3 months. An economic study will also be conducted,~     including work resumption at 3 months.~      This is a multicentric prospective study. Three hundred patients will be randomized in two~     parallel groups: continuous nerve blocks delivered thru remote-controlled electronic pump~     versus single local anesthetics injection.~      The primary endpoint is the EVAN-G patient satisfaction scale, scored at day 2. Secondary~     endpoints will include assessment of pain, opiates consumption, sensitivity and motricity~     scores, rate of catheter falls at home, hospital readmission, patient mobilization, sleep and~     heart rate as assessed by an activity tracker, PCS before the surgery and Quality of Recovery~     (QoR-40) scale at day 1, Short-Form 36 (SF36) at day 45 and Neuropathic Pain assessment (DN4)~     at day 90.~   "
64636|NCT02720952|"~     The study will be conducted in a total of 24 subjects before their 6th birthday, requiring~     replacement therapy for adrenal insufficiency due to either CAH, primary adrenal failure or~     hypopituitarism.~      The study will consist of three consecutive cohorts. Cohort 1 will include 12 subjects aged~     between 2 and < 6 years. If no safety concerns emerge, then 6 subjects aged 28 days to <2~     years will be enrolled (Cohort 2). A review of accumulated data will be undertaken and only~     if again no safety concerns emerge, then 6 neonates aged from birth to <28 days will be~     enrolled (Cohort 3).~      The decision to continue after each cohort will be based on the recommendation of an~     Independent Data Monitoring Committee (IDMC).~   "
64676|NCT02720419|"~     The purpose of this study is to evaluate the relative effectiveness and safety of Synergy~     stent compared to other drug eluting stents.~   "
64641|NCT02720887|"~     The nanoparticles (NP) are defined as particles whose size is no greater than 100 nanometers.~     However, their impact on health remains little evaluated.~      Placental transfer of NP has been proven in many studies in vitro and in vivo in animals, and~     toxicity in the fetus has been studied in many animals. The investigators seem interesting at~     first to establish the mineralogical load in the amniotic fluid in humans.~      The first objective of this study is to determine the mineralogical NP load, quantity and~     composition, in the amniotic fluid in pregnant women.~   "
64642|NCT02720874|"~     This research will evaluate a multifaceted patient-centered intervention in a sample of~     socioeconomically disadvantaged Hispanic adults with rheumatoid arthritis (RA) that~     capitalizes on a partnership between the extended rheumatology healthcare team and each~     patient in order to promote understanding, uptake and adherence to the principles of~     treat-to-target strategy. The primary hypothesis of this study is that the addition of a~     multifaceted intervention incorporating integrated multidisciplinary rheumatologic care,~     nurse-directed self-management education and supportive follow-up, and technology-based at~     home RA symptom monitoring and reporting to clinical guideline-based care will increase RA~     remission rate at 6 months.~   "
64643|NCT02720861|"~     To explore the prevalence of genetic polymorphism on RNF213 rs112735431 gene in~     non-cardioembolic ischemic cerebrovascular disease in Thai patients.~   "
64644|NCT02720848|"~     This is a randomized clinical trial examining the use of a stiffening wire to increase depth~     of maximal insertion during double and single balloon enteroscopy.~   "
64645|NCT02720822|"~     Breathlessness is an overwhelming symptom affecting tens of thousands of Australians every~     day. For many people, it persists even when all the underlying causes have been optimally~     managed (chronic breathlessness). In these circumstances, it often occurs at rest or with~     minimal exertion.~      Evidence from a number of clinical studies suggests that a small, regular dose of morphine~     helps to reduce safely the sensation of breathlessness. However, it is not well established~     which patients derive more benefit and what is the net clinical effect of this treatment~     (weighing benefits and harms).~      This is a phase III, multi-site, randomised, double-blind, placebo-controlled trial with~     patients with chronic obstructive pulmonary disease (COPD) and severe chronic breathlessness~     which will explore several important questions:~        -  Are regular, low doses of morphine at four possible doses over 3 weeks more effective~          than placebo at improving breathlessness?~        -  Does increasing the dose in people who already are experiencing some benefit provide~          even greater reduction in worst breathlessness?~        -  Does the medication have any effect on daily activity and quality of life?~        -  What are the common or serious side effects of this intervention?~        -  Does the benefit from the medication outweigh the side effects it produces?~        -  Are there specific characteristics of people who are more likely to receive benefit from~          extended release morphine?~      Participants will receive once daily extended release morphine (plus laxative, docusate with~     senna), or placebo (placebo laxative) in addition to their usual medication for up to 3 weeks~     at increasing doses.~      Participants will have a medical interview and physical examination to collect some general~     health information, and baseline measurements including; daily activity, symptoms, and~     quality of life. A small amount of blood may be required to check eligibility. Further blood~     samples may be taken at week 1 and 3 to enable testing on how individuals respond to opioids,~     further consent will be obtained for these samples.~      Data on benefits, side effects, and medical care will be collected during comprehensive~     weekly visits. Participants will also fill out a simple diary twice daily for weeks one to~     three of the study, and for one day each week during an optional 3 month extension stage.~      The outcome of this study may enable better management of symptoms and activity in people~     COPD with medicines that are shown to be effective and safe.~   "
64646|NCT02720809|"~     Health2016 is a general population cross-sectional study aimed at completing af monitoring~     program for monitoring chronic disease and risk factors in the period 2006 to 2016. Similar~     studies have been performed in 2006, 2010, and 2013.~   "
64647|NCT02720796|"~     Patients with recurrent or metastatic sarcoma will be consented to develop a patient derived~     xenograft (PDX or TumorGraft) model of their tumor to perform drug sensitivity testing. The~     purpose of the study is to evaluate the accuracy of the patient derived xenograft (PDX) model~     in predicting patient clinical response to the same drug treatment.~   "
64648|NCT02720783|"~     The primary objective of the study is to evaluate the local tolerability of the new~     Econazole/Benzydamine pessary, in comparison with Econazole and Benzydamine stand-alone~     products and placebo. Pharmacokinetics of the study products after single and multiple~     applications o.d. for 3 days, overall local and general tolerability, safety and comfort of~     use will also be evaluated.~   "
64649|NCT02720770|"~     This study evaluates the effect on height of a two year treatment with growth hormone in 19~     children with X linked hypophosphatemic rickets.~   "
64650|NCT02720757|"~     The primary objective of this NIS is to measure changes in physical functioning, a surrogate~     for physical activity and exercise capacity, in COPD patients on treatment with Spiolto®~     Respimat® in routine daily treatment after approximately 6 weeks.~      A secondary objective is to evaluate the patient's general condition (physician's evaluation)~     from Visit 1 (baseline visit at the start of the study) to Visit 2 (final visit at the end of~     the study, approx. 6 weeks after Visit 1), as well as patient satisfaction with Spiolto®~     Respimat® at Visit 2.~   "
64651|NCT02720744|"~     The purpose of this study is to determine whether FT218 is safe and effective for the~     treatment of excessive daytime sleepiness and cataplexy in subjects with narcolepsy.~   "
64652|NCT02720731|"~     The combination of motor disabilities, chronic pain, cognitive disabilities limiting the~     possibilities of communications and repeated potentially painful rehabilitation, exposes~     patients with motor disabilities to a high risk of induced pain in the specialized~     establishments. Induced pain is difficult to detect and is therefore little assessed and~     treated. Currently, little is known about the prevalence and conditions of occurrence of such~     induced pain as the clinical characteristics of patients (children, adults, severity of~     disability), the types of care and the nature of the institutional admission (medical or~     medico-social). Secondary objectives are to identify risk factors related to the induced pain~     and patient characteristics, as well as to create an easy-to-use weekly continuous pain~     assessment tool in a routine clinical set-up.~      All daily life procedures or treatment carried out in children and adults with motor~     disability are collected for 5 days and 1 night. Collected data are clinical and demographic~     characteristics of patients, the intensity of the pain assessed by the care professional~     (FLACC-r) or the patient himself (VAS).~      Clinically, the uncomfortable and painful procedures and risk factors for pain identified by~     this study will help the development of targeted preventive measures within institutions.~     Meanwhile, the study should sensitize Breton teams involved with regards to the induced pain,~     leading them to observe the behavior of patients, to admit any pain related to an act of~     daily life, and to ask for the medical profession to anticipate the painful experience.~   "
64677|NCT02720406|"~     The aim of this study is to evaluate the analgesia efficacy of local ketamine given by two~     different doses in pediatric patients undergoing tonsillectomy operations~   "
64653|NCT02720718|"~     Background~      Excess weight and obesity is the fifth leading risk factor for global death. Bariatric~     surgery is considered as the only effective long-term treatment for morbid obesity.~     Laparoscopic Roux-en-Y gastric bypass is one of the best surgical procedures, since it~     achieves excellent long-term results with a low complication rate. Intestinal anastomosis is~     a very complex and time-consuming procedure in laparoscopy, mainly due to the difficulties of~     knotting the suture in a limited working area. Barbed sutures may enhance this procedure by~     eliminating the need for knot tying.~      Objective The aim of this study is to compare the safety and efficacy of knotless barbed~     sutures (Stratafix) and continuous sutures (Vicryl) for closing the gastrojejunal and~     jejunojejunal anastomosis in obese patients undergoing gastric bypass.~      Study design~      This is a prospective randomized study. Patients will be randomly assigned to one of two~     groups: traditional suture group or knotless suture group. Randomization will be realized by~     sealed envelopes according to a computer-generated sequence of random numbers, which will be~     opened for the surgeon just before starting the anastomosis. During the surgery the~     gastrojejunal and jejunojejunal anastomoses will be performed with a stapler (Echelon 45~     Endopath) and closed with a traditional (Vicryl) or knotless (Stratafix Unidirectional)~     suture. The same surgeon, experienced and specialized in laparoscopic gastric bypass~     technique, will perform all procedures.~      Study population~      Two hundred patients undergoing laparoscopic Roux-en-Y gastric bypass.~      Main study parameters/endpoints~      The primary outcome measure will be the rate of anastomosis-related complications (leakage,~     bleeding, gastric fistula, anastomotic stenosis) at 4 weeks and at 6 months post-op (safety).~     The secondary outcome measure will be the time spent on closing the gastrojejunal and~     jejunojejunal anastomosis (efficacy).~   "
64654|NCT02720705|"~     The aim of this study is to evaluate the efficacy of transbucal dexmedetomidine given in~     preschool children undergoing tonsillectomy operations in the prevention sevoflurane~     agitation.~   "
64655|NCT02720692|"~     The primary objective of this study is to evaluate the safety and tolerability of N1539 in a~     variety of post-surgical conditions.~   "
64656|NCT02720679|"~     The purpose of this study is to collect and store samples and health information for current~     and future research to learn more about the causes and treatment of blood diseases. This is~     not a therapeutic or diagnostic protocol for clinical purposes. Blood and bone marrow as well~     as health information will be used to study and learn about blood diseases by using genetic~     and/or genomic research. In general, genetic research studies specific genes of an~     individual; genomic research studies the complete genetic makeup of an individual.~      It is not known why many people have blood diseases, because not all genes causing these~     diseases have been found. It is also not known why some people with the same disease are~     sicker than others, but this may be related to their genes. By studying the genomes in~     individuals with blood diseases and their family members, the investigators hope to learn~     more about how diseases develop and respond to treatment which may provide new and better~     ways to diagnose and treat blood diseases.~      Primary Objective:~        -  Establish a repository of DNA and cryopreserved blood cells with linked clinical~          information from individuals with non-malignant blood diseases and biologically-related~          family members in order to conduct genomic and functional studies as outlined in the~          secondary objectives.~      Secondary Objectives:~      Utilizing the biorepository, investigators aim to:~        -  Identify novel mutations that associate with disease status in individuals with~          unexplained non-malignant blood diseases.~        -  Identify modifier genes in individuals with defined monogenic non-malignant blood~          diseases.~        -  Identify genetic variants associated with treatment outcomes and toxicities for~          individuals with non-malignant blood disease.~        -  Use transcriptomics, proteomics and metabolomics to investigate biomarkers for sickle~          cell disease (SCD) progression, paint events and the long-term cellular and molecular~          effects of hydroxyurea therapy.~   "
64657|NCT02720666|"~     This study is an open and single-center Phase I clinical research on patients with advanced~     pancreatic cancer, for evaluating their adverse reactions or tolerance to K-001, so as to~     determine the safe and reasonable dosage and dosing regimen.~   "
64658|NCT02720653|"~     Olfactory dysfunction is a cardinal symptom of chronic rhinosinusitis, a disease which~     affects 12.5% of the adult population across all racial and ethnic groups. Previous research~     has documented olfactory deficit in 68% of patients with chronic rhinosinusitis and 20% with~     complete anosmia, suggesting that olfactory dysfunction affects over 25 million individuals~     in the United States with chronic rhinosinusitis. This proposed investigation will be used to~     predict olfactory outcomes following treatments for chronic rhinosinusitis and gain insights~     into mechanisms of olfactory dysfunction in this population.~   "
64659|NCT02720640|"~     The aim of this single-centre study is to assess the safety and efficacy of the Retina~     Implant Alpha AMS (Retina Implant AG, Reutlingen, Germany) in participants with severe visual~     impairment secondary to outer retinal degeneration caused by retinitis pigmentosa (RP). The~     study is sponsored by the University of Oxford and funded by the National Institute for~     Health Research (UK).~   "
64660|NCT02720627|"~     This study is designed to determine the hypothalamic-pituitary-adrenal (HPA) axis suppression~     potential and pharmacokinetic (PK) properties of CB-03-01 Cream, 1%, applied every twelve~     hours for two weeks, in pediatric patients 9 to less than 12 years of age with acne vulgaris.~     Adrenal suppression effects and systemic safety are an important safety concern. The current~     study is designed to investigate these potential concerns under maximal use conditions.~   "
64661|NCT02720614|"~     The purpose of this study is to evaluate the safety of accelerated hypofractionated~     three-dimensional conformal radiation therapy (3 Gy/fraction) concurrent with chemotherapy~     for patients with unresectable stage III non-small cell lung cancer.~   "
64662|NCT02720601|"~     Biliary tract cancers that progress after first line treatment can be difficult to treat.~     There is a great need for an effective, tolerable, easy to administer second-line regimen.~     Previous early phase studies demonstrated that the combination of two chemotherapy drugs,~     irinotecan and capecitabine had activity in this setting. The goal of this study is to~     determine whether this drug combination, as a second-line treatment, can improve progression~     free survival in patients with biliary tract cancers.~   "
64663|NCT02720588|"~     Specific Aims: This study aims to examine the hypothesis that individuals with Autism~     spectrum disorder (ASD) and their unaffected siblings shared alterations in gray and white~     matter volume and their associated intrinsic functional connectivity, to build upon limited~     literature about neuroimaging endophenotypes of ASD. The investigators also aim to test~     whether these shared differences are associated with behavioral autistic traits.~   "
64664|NCT02720575|"~     The objective of this study is to test the bioavailability of vitamin D in bread.~   "
64665|NCT02720562|"~     Resting state functional MRI is widely used for studying brain functional networks. However,~     in-scanner head movement and other non-neuronal noise can disproportionately bias~     connectivity estimates, despite various preprocessing efforts. To address these issues, the~     technique combining data acquisition with multiecho (ME) echo planar imaging and analysis~     with spatial independent component analysis (ICA), called ME-ICA, has been develop to~     distinguish BOLD (neuronal) and non-BOLD (artifactual) components based on linear echo-time~     dependence of signals, and has been demonstrated to successfully remove non-neuronal~     confounds. Nonetheless, such research approach has never been applied in psychiatric~     populations. The study aims to fill in the gap as shown in the following.~   "
64678|NCT02720393|"~     Participants will be randomly assigned to either regular or no-carrageenan prepared diets to~     determine whether the no-carrageenan leads to improvement in glucose tolerance. Hemoglobin~     A1c is the primary outcome measure.~   "
64679|NCT02720380|"~     This study has the aim to assess the effectiveness of the Buteyko method as an adjunct~     therapy in the treatment of children with asthma.~   "
64666|NCT02720549|"~     Ischemic reperfusion injury of cardiopulmonary bypass and postoperative renal dysfunction is~     a common problem which influence poor outcome in subjects undergoing valvular heart surgery.~     The incidence of postoperative renal dysfunction was reported as high as 7~8% in heart~     surgery using bypass, and is thought to be caused by ischemia/reperfusion injury. Remote~     ischemic postconditioning was also reported to be protective for ischemic/reperfusion injury~     in previous animal studies and stoke patients. Therefore, the investigators are trying to~     evaluate the clinical effect of remote ischemic postconditioning on postoperative renal~     dysfunction in subjects undergoing valvular heart surgery with bypass.~   "
64667|NCT02720536|"~     Extended evaluation of deferasirox film-coated tablet (FCT) formulation~   "
64668|NCT02720523|"~     A Phase 2b/3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo in Japanese~     Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Dose of~     Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an~     Inadequate Response to csDMARDs.~   "
64669|NCT02720510|"~     This was a multicenter, open-label, randomized phase II study which were to enroll 112 newly~     diagnosed symptomatic multiple myeloma patients in a 1:1 fashion. Patients were to enroll at~     approximately 20 centers in the United States.~      Patients were to undergo stem cell mobilization with plerixafor plus Granulocyte Colony~     Stimulating Factor (G-CSF), according to investigator discretion, after 4 cycles of induction~     therapy. Study treatment interruption for stem cell collection were not to exceed 30 days.~     All patients were to receive one additional cycle of study treatment after stem cell~     collection and then proceed to autologous transplant using melphalan 200mg/m2(140mg/m2 for~     patients > 70 years), as conditioning.~      After Autologus Stem Cell Transplant( ASCT), patients still on study were to initiate~     maintenance therapy within the 60-120 day period following ASCT, provided they have adequate~     blood count and clinical recovery. Patients in the RVD arm were to initiate maintenance~     therapy with lenalidomide alone, and patients in RVD-panobinostat arm were to receive~     lenalidomide + panobinostat maintenance. Lenalidomide were to be dosed orally at 10mg/day~     continuously in both arms, increasing to 15mg/day after the first 84 day cycle. Panobinostat~     were to be dosed at 10mg three times a week, every other week. Total planned duration of~     maintenance therapy were to be 3 years.~      Patients were to remain on study treatment until they complete the maintenance phase, or~     until they experience disease progression, unacceptable toxicity, or at the discretion of the~     Investigator.~   "
64670|NCT02720497|"~     Objectives and Rationale: With up to 20% of U.S. service members returning from Iraq and~     Afghanistan with PTSD symptoms, a critical need exists for treatments that are both effective~     and efficient, enabling the greatest number possible to be treated to remission. As a highly~     efficacious treatment and the one with the most scientific support, Prolonged Exposure (PE)~     is recommended by the Institute of Medicine and being rolled out by the Departments of~     Defense and Veterans Affairs to help heal our war fighters' psychological wounds. A major~     barrier to that roll-out, however, is that PE is typically delivered in 90-minute sessions.~     This is difficult for military mental health providers, who because of large patient loads~     and pressure to see as many patients per day as possible, limit therapy sessions to 60~     minutes. The primary aim of this randomized clinical trial is to determine whether PE~     sessions can be reduced to 60 minutes without compromising the treatment's high success rate.~     Preliminary evidence suggests that patients may greatly benefit from PE even when the time~     spent recalling and recounting the trauma memories during sessions (a key procedure called~     imaginal exposure) is shortened to fit into a 60-minute session. To test this hypothesis, the~     trial will enroll 160 San Antonio-area active duty service members who will be randomly~     assigned to receive PE treatment with 60- or 90-minute sessions. In an additional effort to~     learn more about how PE helps patients recover - and thereby gain insights to further enhance~     treatment benefit - the study investigators will examine what causes reductions in PTSD~     symptoms during PE by examining self-reported and physiological markers (e.g., heart rate~     reactivity) between the two treatment groups.~      Research Applicability and Impact: If PE can be shown to maintain high success rates with~     shorter sessions, more military clinicians could offer this powerful therapy, as it would fit~     within time constraints of their heavy workload. This would potentially help thousands of our~     nation's warriors recover from the devastating psychological effects of PTSD and maintain~     their military careers, heal hurting relationships, and reengage in meaningful life~     activities. This study would further benefit the military and the general public by enhancing~     the readiness of our Armed Forces and reducing the public cost of service members' lost work~     time or veterans' disability benefits. Overloaded VA providers and even civilian therapists,~     who often limit sessions to 60 minutes due to insurance reimbursement requirements, may also~     be more likely to utilize the shorter treatment format, increasing access to evidence-base~     care for veterans and civilians. In addition, insights from the study's examination of~     biomarkers and underlying mechanisms of PE could be used to enhance care for service members,~     veterans, and the general public. Study risks are minimal, as a small proportion of patients~     may see temporary symptom increases as they deal with traumatic memories, but this is part of~     the recovery process. Patients receiving the shorter treatment sessions potentially may~     realize a lower level of treatment benefits, but preliminary evidence suggests there is good~     reason to believe their treatment will be equally as successful as those receiving~     traditional PE.~   "
64671|NCT02720484|"~     The primary objective will be to assess overall response rate of nivolumab in patients with~     metastatic or locally advanced adrenocortical carcinoma. Nivolumab was recently approved by~     U.S. Food and Drug Administration (FDA) for the treatment of advanced melanoma, non-small~     cell lung cancer and renal cell carcinoma. It is considered investigational for the treatment~     of advanced or refractory adrenocortical carcinoma. Investigational means that the drug is~     not approved by the USFDA or not approved for the indication under investigation. Nivolumab~     could shrink adrenocortical carcinoma but it could also cause side effects. Researchers hope~     to learn if the study drug will shrink the cancer and hopefully to relieve symptoms that are~     related to the cancer.~   "
64672|NCT02720471|"~     Clinical study, comparative, prospective, interventional, randomized, single-center,~     single-blind The fast resumption of the walking after surgery of total prosthesis of hip~     (PTH) requires an effective analgesia from the immediate post-operative period. In France,~     whatever is the peroperative anesthesia, the analgesic reference technique is a locoregional~     anesthesia (ALR) ultrasound guidance by blocks of the femoral and cutaneous nerves side of~     the thigh. In the Anglo-Saxon countries, in particular in Australia and in the United States,~     the techniques of peroperative infiltration of local anesthetics (IAL) by the surgeon~     supplanted the techniques of traditional ALR. However, no French study compares the IAL with~     the conventional ALR with a rigorous methodology. Our occasional practice of IAL suggests us~     that it is more effective in terms of post-operative analgesia with Analog Visual Scales~     decreased (EVA) and a lesser consumption of morphine. Furthermore, the resumption of the~     upright posture in bipedal support as well as the resumption of the walking would be earlier.~      The main objective is to show that the post-operative analgesia by local peroperative~     infiltration is superior to that obtained by locoregional anesthesia (ALR by femoral block~     associated with a side cutaneous block of the thigh) after the surgery of total prosthesis of~     hip, with decrease of the consumption of morphine within first 72 post-operative hours.~      The secondary objectives are to compare the Analog Visual Scales of pain (EVA) with the rest~     and with the mobilization during various times (in post-surgery care room, then at H4, H8,~     H12, H24, H48, H72), the period between the end of intervention (out of the operating room)~     and the first support by the upright posture in bipedal support), the period between the end~     of intervention and the resumption of the walk, the satisfaction of the patients at the exit~     of the hospital, the duration of hospitalization after the surgical operation and the~     possible unwanted events (systematic toxicity of the local anesthetics, the infection of~     prosthesis, disease thromboembolic venous) during the hospitalization.~   "
64673|NCT02720458|"~     Persistent insomnia has a high prevalence in French general population affecting between 15.8~     % and 19 % of adults. In France, the disease is mainly managed by general practitioners (GP)~     who usually proposed intermediate half-life benzodiazepines and Z-drugs in first-line~     treatment. French Health authorities recommend restricting the consumption of both hypnotics~     to no more than 4 weeks, considering their potential adverse effects (memory impairment,~     altered sleep physiology, motor-vehicle crash), and the risk of tolerance and dependence.~     However, it appears that a majority of patients become chronic users. Therefore,~     discontinuation of benzodiazepines/Z-drugs is recommended, but it may appear as a challenge~     due to withdrawal symptoms and psychological factors (anticipatory anxiety, fear of rebound~     insomnia).~      Numerous studies have shown that programs based on Cognitive-Behavioural Therapy (CBT)~     principles improve sleep and daily life quality leading to hypnotic taper and maintain of~     hypnotic abstinence in insomniac patients. Cognitive-Behavioural Therapy (CBT) is based on 4~     components: sleep restriction, stimulus control, cognitive therapy and sleep hygiene~     education. This therapy is dependent on a therapeutic alliance between practitioner and~     patient. Unfortunately, there are an insufficient number of trained CBT experts especially in~     France.~      The implementation of an internet-delivered self-help program based on time-in-bed~     restriction and stimulus control may be an issue within the context of general practice.~      Online programs based on CBT principles have been proved to be effective in improving the~     sleep and daytime functioning in this population, but the studies were realized in small~     patients groups.~      Investigators hypothesis is that a simple and internet-delivered short-term program based on~     sleep restriction therapy and stimulus control (following to a GP consultation) may~     facilitate hypnotics discontinuation (benzodiazepines/Z-drugs) in patient with insomnia~     disorder still reporting sleep complaints in comparison with a tapering alone (no access to~     the self-help program).~   "
64674|NCT02720445|"~     The purpose of the study is to see if daily transdermal nicotine is able to produce a~     significant cognitive, clinical and functional improvement in participants with MCI. Neuronal~     nicotinic receptors have long been known to play a critical role in memory function in~     preclinical studies, with nicotine improving attention, learning, and memory function.~      The study will enroll 300 participants for a 2 year period. Participants will be randomized~     (50:50) to either the transdermal nicotine, beginning at 7mg/day, and increasing to 21mg/day,~     or placebo skin patch.~   "
64675|NCT02720432|"~     This current study proposes to analyze the feasibility and effects of the two most used~     therapies, constraint-induced movement therapy and hand-arm bimanual intensive training, in~     very young infants (less than one year) with perinatal stroke and with a high risk to develop~     hemiplegic CP.~   "
64683|NCT02720328|"~     The purpose of this study is to investigate the preventability of serious adverse drug~     reactions (ADRs) related to the use of direct oral anticoagulants (DOACs). The investigators~     also aim at identifying the underlying causes of these preventable ADRs. The endpoint~     measurements will be compared with a group of patients taking vitamin-K antagonists (VKAs).~     For this purpose, a protocol for a prospective observational study was developed. The study~     was approved by the Ethics Committee of the CHU UCL Namur (site Godinne) and the Cliniques~     Universitaires Saint-Luc. Patients admitted to the emergency department of these two teaching~     hospitals with a thrombotic or a bleeding event while under DOAC or VKA are included. After a~     comprehensive medication history, the appropriateness of prescribing is evaluated, using an~     adapted version of the Medication Appropriateness Index. Causality, severity and~     preventability of adverse events are assessed by two pharmacists and two hematologists using~     predefined scales. Second, for cases of serious and preventable ADRs, semi-structured~     interviews are performed with general practitioners to understand the underlying causes of~     medication errors. Based on the results, risk-minimization strategies that specifically~     target the problems encountered in clinical practice will be proposed.~   "
64684|NCT02720315|"~     Acute musculoskeletal (MSK) injuries, including strains, sprains or contusions, are a common~     reason patients seek emergency care. Pain control is an essential component of treatment.~     Within the orthopedic literature, there is robust body of research supporting the use of~     cryotherapy for post-operative patients and injured athletes. However, within the emergency~     department (ED), studies have been focused on pharmacologic analgesia. The absence of~     evidence on optimal method or impact of ice therapy for acute MSK injuries contributes to~     inconsistent practice patterns that may impede symptom control or increase narcotic usage.~      The specific aim of the ICED investigation is to evaluate the effectiveness of intensive~     cryotherapy for the treatment of pain due to acute MSK injuries treated in the ED. Secondary~     outcomes include length-of-stay (LOS), patient satisfaction, and narcotic usage.~   "
64685|NCT02720302|"~     The present study is a public health project with the aim to treat overweight in children~     9-11 years of age. After the first consultation the children are randomized to either~     continue the treatment at The Child Obesity Clinic, Child Department or to have the following~     2-3 consultations on distance with Lync. Last visit for all children is on the Child Obesity~     Clinic after approximately 12 months. Follow up after at least 1 years will be performed.~   "
64686|NCT02720289|"~     This study compares a video-based social learning method to the traditional didactic method~     as a new way to teach caregivers about child passenger safety, including how to install a car~     seat. Half of the caregivers will attend the video-based social learning class, while the~     other half will attend the traditional didactic class. The investigators hypothesize that the~     video-based social learning method will lead to an equal or greater increase in caregiver~     child passenger safety proficiency when compared to the traditional didactic method.~   "
64687|NCT02720276|"~     The purpose of this exploratory study is to investigate how a predetermined outdoor walking~     program (12 weeks) is best delivered to individuals with stroke over 18 years, either by~     smartphone and the Short Message Service (SMS) or video link.~      Furthermore, the aim is to investigate how the study design works in practice and determine~     the effects of the outdoor walking exercise program in combination with a leg exercise on~     physical functioning (walking capacity, gait speed, mobility and grip strength).~   "
64688|NCT02720263|"~     The purpose of this study is to evaluate the safety and tolerability of multiple ascending~     oral doses of ASP4345 in patients with schizophrenia. In addition, this study will evaluate~     the pharmacokinetics of multiple ascending oral doses of ASP4345 in patients with~     schizophrenia.~   "
64689|NCT02720250|"~     Previous studies have shown that omega-3 fatty acid pills intake have beneficial effect on~     vascular health in overweight and/or hypertensive patients.~      However, there is a lack of studies showing the effect of everyday consumption of omega-3~     fatty acids enriched food (not pills) on lipid profile and microvascular reactivity in~     healthy population.~      This study aimed to determine the effect of omega-3 enriched chicken eggs consumption on~     microvascular reactivity and lipid profile in young healthy subjects.~   "
64690|NCT02720237|"~     The purpose of this study is to compare the effectiveness of two interventions [a Brief~     Intervention (BI) and a Motivational Enhancement Therapy+Cognitive Behavioral Therapy~     (MET+CBT) Intervention], against each other and with an assessment-only control, in improving~     both alcohol- and HIV-related outcomes, among hazardous and heavy drinking HIV-infected~     antiretroviral therapy (ART) clinic clients in Thai Nguyen, Vietnam.~   "
64691|NCT02720224|"~     This study is being conducted to further understand the elimination pathways, metabolite~     profile and pharmacokinetic (PK) profile of carbon 14 labelled estetrol ([14C] estetrol).~   "
64692|NCT02720211|"~     Nearly all migraine sufferers report sensitivity to light during a headache and a significant~     proportion of sufferers report light sensitivity between attacks. Light is also a common~     trigger for migraine headaches. Spectacle lenses that have been treated with tints and~     spectacle lenses that have been treated with thin-films have both been shown to reduce light~     sensitivity and headache in patients with migraine. At this time, it is not clear which~     spectacle lens treatment is superior. The purpose of this trial is to determine if there's a~     significant, therapeutic advantage to either spectacle lens treatment. Both treatments could~     be a novel, non-invasive adjuvant in the treatment of migraine.~   "
64693|NCT02720198|"~     This study's primary objective is to compare the efficacy and tolerability of switching~     patients with inadequate relief on generic SSRIs to levomilnacipran versus adding a new~     treatment (quetiapine) to the participants' existing treatment with people diagnosed with~     depression (major depression disorder).~      The secondary objective is to examine the response and remission rates following the switch~     from a generic SSRI to levomilnacipran ER and augmentation with quetiapine along with~     examining changes in neurocognitive and apathy measures after the switch.~   "
64727|NCT02719756|"~     This study will test the hypothesis that early use of combination therapy with dapagliflozin~     and metformin will provide good glycemic control with low glycemic variability and without~     hypoglycemic episodes, and will be better tolerated than up-titration of metformin~     monotherapy. The study will also correlate these benefits with glycated hemoglobin.~   "
64728|NCT02719743|"~     The purpose of this study is to assess the safety and immunogenicity of different~     formulations of GSK Biologicals' influenza candidate vaccine GSK1557484A, in children 6-35~     months of age.~   "
64694|NCT02720185|"~     Primary Objective:~      To determine if dasatinib, an inhibitor of the Src family kinases, can prevent the nuclear~     translocation of the epidermal growth factor receptor (EGFR) in Stage I-III, nuclear EGFR~     positive, triple negative breast cancers (TNBC).~      Secondary Objectives:~        1. To examine the safety and tolerability of dasatinib in patients with operable TNBC~        2. To explore potential intracellular mechanisms which impact dasatinib effect on cellular~          localization of EGFR in operable TNBC.~        3. To examine the pathologic complete response (pCR) rates to standard neoadjuvant~          chemotherapy in nEGFR+ TNBC~        4. To examine breast cancer recurrence rates and patterns of metastatic recurrent in nEGFR+~          TNBC~   "
64695|NCT02720172|"~     The overall objective of this two-group randomized controlled trial is to gather preliminary~     evidence on the efficacy and safety of early postoperative exercise for improving disability,~     pain, and general physical health in patients after anterior cervical discectomy and fusion~     (ACDF) surgery. Our central hypothesis is that an early home exercise program (HEP) performed~     within the first six weeks after surgery will decrease disability and pain and improve~     general health, through increases in physical activity and self-efficacy and reductions in~     fear of movement. The results of our randomized trial will advance research on postoperative~     management for patients with cervical spine surgery and provide evidence in line with a~     value-based healthcare approach for optimizing outcomes.~   "
64696|NCT02720159|"~     The purpose of the clinical study is to characterize the efficacy and safety of a~     Percutaneous Osseointegrated Prosthesis (POP) device that can provide a satisfactory platform~     for direct skeletal attachment of prosthetic limbs, which includes a subdermal seal, thus~     allowing a proper biobarrier around the implant.~   "
64697|NCT02720146|"~     Poor corneal epithelialization problem can be found in a lot of ocular surface disorders,~     including limbal insufficiency, dry eye, chemical burn and neurotrophic disorders. Delayed~     corneal epithelialization under any circumstances can lead to corneal infection, corneal~     melting, corneal opacity, pain or blurred vision. It is thus important to develop~     pharmacological methods to promote corneal epithelial wound healing in those patients.~     Previously, various epitheliotrophic growth factors, autologous serum, cord blood serum, etc.~     have been proved to be effective in promoting corneal epithelial wound healing. However,~     those topical agents have the drawbacks including the difficulties during preparation,~     expensive price, non-standardized quality and the risk of contamination during preparation.~     It will be clinically important to find other blood derivatives which are effective,~     convenient for use, stable in quality and being cheap.~      During the recent few years, various platelet related blood derivatives have been proved to~     contain a lot of epitheliotrophic growth factors, and can promote wound healing. Among those~     products, platelet lysate has the benefits of being commercially available. It can avoid~     the complicated producing procedure, and has stable quality. Although platelet lysate has~     been widely used in various medical fields, especially in culturing mesenchymal stem cells,~     its potential in promoting corneal epithelial wound healing has not been proven. The purpose~     of this project is to explore the possibility of using platelet lysate to treat patients with~     poor corneal epithelialization problem, and compare its epitheliotrophic ability with other~     blood derivatives. The cultured human corneal epithelial cell line will be used for all~     experiments, and will be cultured with media containing different blood products: (1) control~     group without blood derivatives, (2) fetal bovine serum, (3) human serum, (4) platelet lysate~     commercial product—UltraGro, (5)platelet lysate commercial product---PlatMax. MTS assay will~     be used to measure proliferation ability. Scratch-induced directional wounding assay and~     Boyden chamber chemotaxis assa will be used to measure cell migration. Scanning electron~     microscopy, transmission electron microscopy, transepithelial electric resistance (TEER) and~     immunohistochemistry with junctional proteins will be used to measure cellular~     differentiation. Through these experiments, the investigator aim to understand whether~     platelet lysate can replace other blood derivatives, and be used for treating patients with~     corneal epithelialization problem.~      Beside, current medications in dry eye are all manufactured, transported and used in the form~     of liquid form. However, it is more disturbing in transporting, commercializing, storing and~     the limitation of expiration date for current medications compared with powder form~     medications. Therefore, improving the convenience of utilizing and storage without at the~     expense of the efficacy of blood-derivatives has become a critical issue. Our study also~     aimed at trying to produce platelet-related derivatives (including platelet lysate) and human~     serum into the form of dry powder and resuspended it with preservative-free artificial tears.~     The investigator would compare the epitheliotrophic ability of the liquid form of blood~     derivatives and the powder form of blood derivatives.~      Since human serum is needed for comparison , the investigator proposed this IRB to collect~     human serum from healthy volunteers。~   "
64698|NCT02720133|"~     Ramadan Fasting has multiple effects on the variation of hematological and biochemical~     parameters.~   "
64699|NCT02720120|"~     This study is in two parts and will evaluate the safety, tolerability and efficacy of~     escalating single intravenous (IV) doses of ocrelizumab compared with placebo in combination~     with methotrexate in participants with moderate to severe RA. Part 1 is the dose-escalation~     study, at one of the following dose levels of ocrelizumab [400, 1000, 1500, and 2000~     milligrams (mg)]. In Part 2, participants will be randomized to explore tolerability and~     efficacy of doses which have been shown to be tolerated in Part 1.~   "
64700|NCT02720107|"~     The purpose of this single visit extension study is to explore immune status in RRMS patients~     treated for at least 48 months with fingolimod. Long-term changes in T cell counts will be~     compared to short-term changes in immune status (baseline to month 6) after treatment start~     with fingolimod as assessed in the original Biobank study (CFTY720DDE01).~   "
64701|NCT02720094|"~     This study will evaluate the safety and efficacy of the injectable drug cabotegravir (CAB~     LA), for pre-exposure prophylaxis (PrEP) in HIV-uninfected cisgender men and transgender~     women who have sex with men (MSM and TGW).~   "
64702|NCT02720081|"~     The purpose of this trial is to compare the safety, tolerability, and efficacy of adding~     MK-1029 to montelukast in adults with persistent asthma that is uncontrolled while receiving~     montelukast alone. Participants will have a specific genetic marker for clinical efficacy of~     MK-1029. The primary hypothesis is that when added to montelukast, treatment with MK-1029 is~     superior to placebo, as demonstrated by an increase in forced expiratory volume in one second~     (FEV1), measured as the average change from baseline at the end of Week 4 and Week 6 of~     treatment.~   "
64703|NCT02720068|"~     This is a safety and pharmacokinetics study of MK-4280 as monotherapy and in combination with~     pembrolizumab (MK-3475) in adults with metastatic solid tumors for which there is no~     available therapy which may convey clinical benefit. Part A of this study is a dose~     escalation design in which participants receive MK-4280 as monotherapy or MK-4280 in~     combination with pembrolizumab. Part B is a dose confirmation design to estimate the~     recommended Phase 2 dose (RPTD) for MK-4280 in combination with pembrolizumab in participants~     with advanced solid tumors.~   "
64704|NCT02720055|"~     A randomised controlled trial to compare two different rehabilitation work books used in~     patients with wrist fracture.~   "
64705|NCT02720042|"~     The purpose of this study is to collect additional data on safety and performance of Phasix™~     Mesh in subjects requiring VHWG Grade 3 midline hernia repair.~   "
64706|NCT02720029|"~     Monitoring and quantification of reflux events in high risk critically ill inpatients and~     lower risk general medical/surgical inpatients, with comparison to relevant clinical~     variables.~   "
64707|NCT02720016|"~     Untreated posttraumatic stress disorder (PTSD) is a costly condition associated with~     impairment in functioning across a host of psychosocial domains including occupational and~     academic functioning, marital and family functioning, parenting, and socialization.~     Impairment is not limited to Veterans with PTSD because the entire family is affected,~     particularly the Veteran's intimate partner. PTSD symptoms can produce negative effects on~     both members of the dyad. Despite the need for treatment, many Veterans and their families do~     not access PTSD-related services due to a number of barriers to accessing care (e.g., living~     in rural or remote areas where no specialty services exist, concerns about stigma around~     using mental health services, limited clinic hours to accommodate patient schedules). The~     objective of this study is to assess whether providing Cognitive-Behavioral Conjoint Therapy,~     in which PTSD symptoms and intimate relationship functioning are addressed, to Veterans and~     their romantic partners in their homes via clinical video teleconferencing leads to better~     outcomes compared to office based treatment.~   "
64708|NCT02720003|"~     To assess the safety and efficacy of the BARD LTX DCB for treatment of stenosis or occlusion~     of the superficial femoral and popliteal arteries.~   "
64709|NCT02719990|"~     Open-label extension study to evaluate the safety of long-term twice-monthly administration~     of somavaratan in adults with Growth Hormone Deficiency (GHD).~   "
64710|NCT02719977|"~     CX5461 is a new type of drug for many types of cancer, particularly cancers that cannot~     easily repair damage to their cells. This may help to slow down the growth of cancer or may~     cause cancer cells to die. CX5461 has been shown to shrink tumours in animals and has been~     studied in a few people and seems promising but it is not clear if it can offer better~     results than standard treatment.~   "
64786|NCT02718950|"~     The purpose of this study is to access liraglutide influence brown adipose tissue recruitment~     and its thermogenic effect through hypothalamic activation in obese individuals.~   "
64711|NCT02719964|"~     The objective of this proposal is to evaluate the effectiveness of rehabilitation for visual~     attention deficits in U.S. military service members across three programs: Visual Attention~     and Working Memory Programs (UCR Games), Speech Pathologist-Directed Treatment, and General~     Cognitive Rehabilitation Games (Lumosity).~      In addition to the above prospective component, this study also has a retrospective component~     in which archival data collected from routine clinical care will be examined for analysis.~     The investigators hope to gain a better understanding of the unique and cumulative influence~     different cognitive rehabilitation programs have on improving attention complaints in mTBI.~   "
64712|NCT02719951|"~     Glutamatergic transmission exploration using PET (Positron Emission Tomography) imaging in~     autism compared to Fragile-X Syndrome ( FXS) and Healthy Volunteers~   "
64713|NCT02719938|"~     The objective of this study is to generate preliminary data for a large multi-site randomized~     clinical trial of a model of palliative care consultation for patients with advanced~     dementia, and for their family caregivers.~   "
64714|NCT02719925|"~     The goal of clinical trial is to evaluate the effect of one month of consumption of mineral~     water rich in magnesium or not on perceived stress, duration and quality of sleep in healthy~     consumers having magnesium daily intakes below the recommended dietary allowance (RDA).~   "
64715|NCT02719912|"~     This study evaluates the MValve mitral prosthesis in conjunction with a Lotus transcatheter~     heart valve (THV) for mitral valve replacement in subjects at high risk for conventional~     mitral valve replacement or repair surgery.~   "
64716|NCT02719899|"~     Background:~      Researchers want to better understand the body s immune response to calorie restriction. To~     do this, they are asking healthy volunteers to fast for 24 hours. Researchers will test~     immune response before and after fasting.~      Objectives:~      To explore the benefits of calorie restriction on immune health.~      Eligibility:~      Healthy volunteers ages 21 to 37 with a body mass index between 22 and 29.~      Design:~      Participants will be screened with medical history, physical exam, and blood tests.~      Participants will visit NIH after an overnight fast. Their baseline immune response will be~     taken. They will give blood and urine samples. Then they will be given breakfast. This visit~     will take about 2 hours.~      Participants will fast (not eat or drink anything except water) for the next 24 hours. They~     will return to NIH the next morning. Their immune response will be taken. They will give~     blood and urine samples. Then they will be given breakfast. Their immune response will be~     taken 3 hours later. They will give a blood sample. This visit will take about 4 hours.~   "
64717|NCT02719886|"~     The purpose of this randomized controlled trial is to compare the frequency of the diagnosis~     of fetal growth abnormalities when ultrasound assessment is performed at 2 versus 4 week~     intervals.~   "
64718|NCT02719873|"~     A study will carried out over a period of one year , all obese pregnant women as diagnosed~     with BMI at the time of 1st ANC visit and before labor ,observation of events during both~     intra-partum &postpartum periods it will be recorded.outcome will compared with normal other~     pregnant women~   "
64719|NCT02719860|"~     The overall objective of this study is to determine the effect of high tea consumption on~     biological markers of oxidative stress that mediate lung cancer risk.~   "
64720|NCT02719847|"~     The goal of this clinical research study is to compare the results of EBUS-TBNA with the~     results of PET/CT scans to learn about the accuracy of these ways to find evidence of early~     stage lung cancer.~   "
64721|NCT02719834|"~     Behavioral expressions, such as agitation and aggression, affect up to 90% of persons with~     dementia and are a major source of patient and caregiver distress, nursing home placement,~     anti-psychotic medication use, restraints, and increased health care costs. The purpose of~     the research study is to investigate whether reducing pain reduces behavioral expressions of~     Alzheimer's disease (agitation and aggression).~   "
64722|NCT02719821|"~     The goal of this project is to refine and evaluate the feasibility of a brief, behavioral~     intervention to improve the recovery following hematopoietic stem cell transplantation~     (HSCT). Cancer patients who were treated with HSCT will learn behavioral techniques to~     improve sleep and increase daytime activity with the goal of alleviating insomnia, fatigue,~     and depression after HSCT. If the intervention is feasible and acceptable to patients, a~     future study will test the effects in a larger trial, with the long-term goal of improving~     the care and quality of life of cancer survivors recovering from HSCT.~   "
64723|NCT02719808|"~     500 pregnant patients with HBeAg-positive and HBV-DNA> 106copies /ml who will do their~     pregnant check in the First Affiliated Hospital of Xi'an Jiaotong University will be enrolled~     into the study. There will be five groups to be observed. Four groups are taking tenofovir to~     prevent intrauterine infection during pregnancy. One group is not taking any anti-HBV virus~     treatments.The clinical value and effectiveness of tenofovir on blocking HBV intrauterine~     infection will be evaluated; The HBV-DNA infection status of placenta tissue will be checked~     by quantitative Polymerase Chain Reaction (PCR) to assess the changes of HBV-DNA of placenta~     after treating with tenofovir and explore the mechanism of tenofovir blocking HBV~     intrauterine infection. The safety of Tenofovir will be assessed as well.~   "
64724|NCT02719795|"~     The purpose of this study is to determine whether pectoral nerves blocks（PECS） would reduce~     chronic pain at 3 months after modified radical mastectomy（MRM）surgery.~   "
64725|NCT02719782|"~     Hepatocellular carcinoma (HCC) recurrence rate is high among liver transplant patients, while~     treatment measures are limited. This study plans to recruit 10 patients with Hepatitis B~     virus (HBV) related HCC who underwent liver transplantation and are confirmed to have~     recurrent HCC. The objective of the study is to assess the safety, tolerability and~     effectiveness of the HBV specific T cell receptor (HBV/TCR) redirected T cell in the target~     population.~   "
64726|NCT02719769|"~     The Evaluation of Clinical Performance of the Accelerate ID/AST System for Positive Blood~     Culture Identification & Antimicrobial Susceptibility Testing is designed to validate the~     clinical performance of the Accelerate ID/AST System for positive blood culture~     identification and susceptibility testing in a clinical setting. The data from this study~     will be used to support the 510(k) submission for FDA clearance and global registrations of~     the device intended for in vitro diagnostic use.~   "
64787|NCT02718937|"~     The primary purpose of this study is to evaluate the antiviral activity of oral BTA-C585~     compared to placebo in healthy volunteers after intranasal challenge with RSV-A Memphis 37b~     virus.~   "
64729|NCT02719730|"~     This study will assess the impact of a randomized intervention aimed at increasing~     consumption of whole grain foods among children from low-income households that participate~     in the Special Nutrition Assistance Program (SNAP, or food stamps). A total of 60 obese~     children (8 to 16 years) will be recruited from a clinical population (Healthy Eating Active~     Living Program) at University of California San Francisco (UCSF) Benioff Children's Hospital~     Oakland. Participants and their caregivers will all receive education about whole grain~     foods, and will be randomized to either an intervention or control group. The intervention~     group will receive a monthly reimbursement allotment of up to 10% of their usual SNAP benefit~     for specific whole grain foods purchased during the three month study period. The control~     group will not have the financial incentive for purchasing whole grain foods during the 12~     week study period. The investigators will assess the feasibility of the intervention, the~     impact of the intervention on household grocery purchases, and the impact on the child's~     anthropometrics, dietary intake of whole grain foods (24-hour recall), and markers of~     metabolic risk.~   "
64730|NCT02719717|"~     This research program consists of a prospective, multi-institutional Phase 2 trial and an~     economic cost-effectiveness analysis for the use of ACE+7 in VATS lobectomy/segmentectomy~     compared to traditional techniques.~      It will be left up to the study credentialed surgeon investigator to decide the suitability~     of PA branches for sealing. This will be decided intra-operatively based on anatomy, vascular~     dissection and length as well as patient specific factors.~   "
64731|NCT02719704|"~     The main purpose of this study is to analyse the effect of a multicomponent intervention,~     applied during one scholar semester, on body composition, strength, flexibility,~     cardiorespiratory fitness, lipid and metabolic profile, and body image of students from sixth~     to ninth grade. This is a non-randomized controlled design. Approximately 568 schoolchildren~     of grades sixth through ninth were recruited from 2 public secondary schools in~     Florianópolis, Brazil. The main component of the intervention entitled MEXA-SE (move~     yourself) consisted of the implementation of three physical education classes per week with~     aerobic exercises, strength and flexibility activities. In addition, play activities in~     school recess, and educational activities on physical activity, sedentary behaviour, eating~     habits and body image were performed. Data collection was performed before and immediately~     after 14 weeks of intervention. The primary outcomes included the body composition, strength,~     flexibility, cardiorespiratory fitness, lipid and metabolic profile, and body image. Other~     variables included were: physical activity level, sedentary behaviour, and blood pressure~     level. Other components of the lifestyle (e.g., eating habits), psychological (e.g.,~     self-rated health) also were evaluated in the participants. Descriptive analysis, two-way~     ANOVA for mixed models and ANCOVA will be applied for within and between comparison groups,~     if the premises of this test are met. The level of significance for the study was 5% for~     two-tailed tests.~   "
64732|NCT02719691|"~     This is a phase Ib study designed to evaluate the safety and toxicity of the combination of~     Alisertib and MLN0128 in patients with advanced solid tumors with an expansion cohort in~     patients with previously treated metastatic TNBC.~   "
64733|NCT02719678|"~     The effect of systematic health examinations and screening of the general population is under~     debate. Recently, a large Danish randomized study found that systematic screening of risk~     factors and lifestyle advice in the general population did not have a preventive effect on~     coronary heart disease, stroke or all-cause mortality. However, there are still very few~     completed randomized studies, and the effect on other diseases remains unclear. The purpose~     is to investigate whether repeated health examinations with screening of various risk factors~     in an unselected population prevent long-term incidence of ischemic heart disease, stroke,~     total and cause-specific mortality, diabetes, dementia, chronic obstructive pulmonary disease~     and various forms of cancer. A preliminary protocol was submitted and approved by the Danish~     Data Protection Agency before the registry-based data on primary and secondary outcomes were~     received by the investigator.~   "
64734|NCT02719665|"~     The purpose of this study is to understand the effects of fish oil supplement (containing~     parts of omega-3 fatty acids) on inflammation. The investigators are aiming to identify which~     dose of the fish oil supplement is the most effective. The name of the fish oil supplement is~     SPM Emulsion.~   "
64735|NCT02719652|"~     Intracranial atherosclerotic disease (ICAD) is an important cause of ischemic stroke. The~     occurrence of stroke caused by symptomatic ICAD is significantly different compared with~     asymptomatic ICAD (19% vs 3.5%), suggesting that plaque vulnerability may be responsible for~     the difference. Based on the previous high-resolution magnetic resonance vessel wall imaging~     (HR-MRI) results, the investigators hypothesis that the feature of intracranial plaque~     enhancement is an important imaging biomarker of plaque instability, which is closely related~     to stroke. The investigators will establish the ICAD cohort and use HR-MRI to investigate the~     composition, morphology and the enhancement pattern of symptomatic ICAD plaques. These~     findings will correlate with biochemical markers, and stroke recurrence, in order to explore:~        1. plaque characteristics and the enhancement features between symptomatic ICAD and~          asymptomatic ICAD~        2. the relationship between plaque enhancement and the composition of plaques;~        3. relationship among enhancement features of symptomatic ICAD plaques, biomarkers with~          different clinical significance,~        4. evolution of enhancement features of symptomatic ICAD plaques under intensive medical~          therapy.~      The investigators aim to explore the correlation between vulnerable plaque stratification and~     clinical outcomes, to explore the value of vascular responses in the pathogenicity of ICAD~     vulnerable plaques, as well as to provide objective basis for the establishment of the~     evaluation criteria of intracranial atherosclerotic vulnerable plaques.~   "
64736|NCT02719639|"~     Real-world data on the effects of a fixed-dose combination Long-acting beta agonists +~     long-acting antimuscarinic agent (LABA+LAMA) therapy with tiotropium and olodaterol~     administered in a single device, in COPD patients who need treatment with two long-acting~     bronchodilators, is not available. This is a self-controlled study design enrolling consented~     COPD patients who will be treated with Spiolto Respimat according to the approved Summary of~     Product Characteristics (SmPC).~   "
64802|NCT02718742|"~     This phase II trial studies how well paclitaxel albumin-stabilized nanoparticle formulation~     maintenance therapy works after cisplatin-based chemotherapy and surgery in treating patients~     with high-risk bladder cancer. Maintenance therapy, such as paclitaxel albumin-stabilized~     nanoparticle formulation, can help keep cancer from coming back after it has disappeared~     following initial chemotherapy.~   "
64737|NCT02719626|"~     Rutgers University will partner with the Meals on Wheels America (MOWA) and affiliated~     agencies in five states to conduct a study designed to improve food safety nutrition and~     emergency preparedness among homebound elderly recipients of home delivered meals (HDM). This~     population is at increased risk for food borne diseases, as a result of unique physiological~     and behavioral factors, and is particularly vulnerable to any disruptions in the food system~     because of their lack of mobility.~      A multi-method research approach will be used with a target sample of 1,000 MOWA homebound~     elderly clients. Methods include the use of a novel UPC scanning technology that quickly and~     comprehensively catalogues all of the food in the clients' homes, a home food safety audit,~     and a face-to-face interview.~      The goal of the study is to provide an improved understanding of the unique food safety~     threats to this at-risk population, suggest easy, cost-effective ways of reducing known food~     safety risk factors, and provide clear guidelines about the amount and types of food most~     needed by this population in emergency situations. Dissemination of research findings and~     recommendations will be done through a partnership with EDEN and MOWA, both of which have~     national constituencies poised to act on the recommendations.~   "
64738|NCT02719613|"~     The purpose of this study is to continue to provide elotuzumab and/or other study drugs to~     subjects who have participated on a prior protocol investigating elotuzumab who are not able~     to receive commercial drug supply.~   "
64739|NCT02719600|"~     Background: Down syndrome (DS) has unique physical, motor and cognitive characteristics.~     Despite cognitive and motor difficulties, there is a possibility of intervention based on the~     knowledge of motor learning. However, it is important to study the motor learning process in~     individuals with DS during a virtual reality task to justify the use of virtual reality to~     organize intervention programs. The aim of this study was to analyze the motor learning~     process in individuals with DS during a virtual reality task. Methods: A total of 40~     individuals participated in this study, 20 of which were with DS (24 males and 8 females,~     ranging between 11-28 yrs.) and 20 typically developing individuals matched by age and gender~     to the individuals with DS. To examine this issue, we used software that uses 3D images and~     reproduced a coincidence timing task.~   "
64740|NCT02719587|"~     The investigators primary objective in this clinical intervention study, therefore, was to~     explore the impact of omega-3 PUFAs in conjunction with scaling and root planing on salivary~     markers (in patients with chronic periodontitis.~   "
64741|NCT02719574|"~     This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 as a single~     agent or in combination with azacitidine or cytarabine. The Phase 1 stage of the study is~     split into 2 distinct parts: a dose escalation part, which will utilize an open-label design~     of FT-2102 (single agent) and FT-2102 + azacitidine (combination agent) administered via one~     or more intermittent dosing schedules followed by a dose expansion part. The dose expansion~     part will enroll patients in up to 5 expansion cohorts, exploring single-agent FT-2102~     activity as well as combination activity with azacitidine or cytarabine. Following the~     completion of Phase 1, Phase 2 will begin enrollment. Patients will be enrolled across 6~     different cohorts, examining the effect of FT-2102 (as a single agent) and FT-2102 +~     azacitidine (combination) on various AML/MDS disease states.~   "
64742|NCT02719561|"~     Fatigue is one of the most common and distressing symptoms in teenage and young adult cancer~     patients. Despite this, there has been virtually no research evaluating treatment for~     cancer-related fatigue in this young patient group. The investigators are undertaking a small~     qualitative study to co-design a fatigue intervention, that will then be evaluated in future~     research to assess its effectiveness.~   "
64743|NCT02719548|"~     A prospective, randomized, 2-phase/crossover, single center premarket feasibility study. In~     phase I the comfort will be assessed, the occurence and types of adverse events will be~     recorded and the assessment how and if the different breast shield designs interact with the~     lacting breast during pumping. Phase II takes place at home; assessment of adverse events~     will be recorded and the assessment how the subjects perceives the comfort of the soft edge~     breast shield during mid term use at home.~   "
64744|NCT02719535|"~     The aim of the proposed study is to investigate the predictive value of corneal biomechanical~     properties in corneal reshaping therapy and the role of these parameters in determining the~     amount of myopia reduction.~   "
64745|NCT02719522|"~     This is a prospective, single-arm, multi-center post-market observational study assessing the~     performance of the Pipeline™ Flex Embolization Device with Shield Technology™ in subjects~     undergoing treatment for intracranial aneurysms in a large real-world, post-market setting.~   "
64746|NCT02719509|"~     This is a prospective observational study evaluating the diagnostic utility of cardiac~     ultrasound in patients who present to the emergency department with undifferentiated chest~     pain or shortness of breath. Emergency department providers will be interviewed before and~     after the completion of a cardiac ultrasound to determine if the ultrasound resulted in any~     changes in management. Other outcomes include determination of incidence of unexpected~     findings.~   "
64747|NCT02719496|"~     The main objective of this study is to evaluate the efficacy of STW5 Iberogast, over a 28-day~     period, for the treatment of constipation in parkinsonian patients suffering from~     gastrointestinal disorders.~   "
64748|NCT02719483|"~     The purpose of this study is to determine whether radial extracorporeal shock wave therapy in~     combination with traditional physical therapy is safe and effective for the management of~     spastic plantar flexor muscles in patients with cerebral palsy younger than averaged three~     years of age.~   "
64749|NCT02719470|"~     In order to explore the question how an intensive, goal-based and aerobic rehabilitation~     treatment, addressed to act on motor and mental aspects, affects motor and functional~     symptoms in PD patients with normal cognition and with different level of cognitive~     impairment. Hypothesis is that a specific rehabilitation program based on motor-cognitive~     training and repetition, can affect positively the rehabilitation outcome regardless of~     baseline cognitive profile.~   "
64750|NCT02719457|"~     the aim of this study to assess the relationship and compare physiological response between~     spot marching exercise test and 6 minute walk test in patient with chronic obstructive~     pulmonary disease~   "
64751|NCT02719431|"~     The purpose of this study is to assess the effects of K-877 on the pharmacodynamics and the~     pharmacokinetics of warfarin in healthy adults volunteers.~   "
64752|NCT02719418|"~     The purpose of this study is to assess if accumulation of anti-Xa activity occurs after~     repeated daily administration of prophylactic doses of tinzaparin in patients with severe~     chronic kidney disease (CKD) requiring thromboprophylaxis for non-surgical conditions.~      It is anticipated that tinzaparin used at a fixed dose for thromboprophylaxis in severe CKD~     patients (eGFR ≤ 30 ml/min /1.73 m2) at risk for venous thromboembolism (VTE) will not~     bioaccumulate at a significant level, meaning an increase of ≥ 20% of the anti-Xa mean level~     between day 2 or 3 and day 5.~   "
64753|NCT02719405|"~     Primary Endpoint~      -The percentage of subjects who develop tolerance to cow's milk protein by 12 months post~     randomization to study formula.~      Secondary Endpoints~        -  Tolerance~             -  The transcriptional profile of milk-specific T cells by clinical outcome.~             -  Growth and Weight Velocity~             -  Stool Consistency and Frequency~             -  The estimated frequency of milk-specific T cells by clinical outcome.~             -  The TCR diversity of milk-specific T cells by clinical outcome.~             -  The milk allergen component-specific IgE, IgG4 and IgA by clinical outcome.~        -  Safety~             -  The rate of reported adverse events by treatment group.~   "
64754|NCT02719392|"~     The purpose of the Pilot Study Investigating the Efficacy of Minocycline and n-acetylcysteine~     for Bipolar Depression is to test the effectiveness of minocycline, n-acetylcysteine, and~     combined minocycline and n-acetylcysteine pharmacotherapy in order to fill the gap in~     treatments for bipolar depression. The treatment of bipolar depression remains the greatest~     unmet need in the management of this lifelong and chronic psychiatric disorder.~   "
64755|NCT02719379|"~     Advisory Committee for Immunization Practices (ACIP) from the Centers for Disease Control~     (CDC) recommends that children (6-18 years) and adults (≥19 years old) with chronic lung~     condition such as asthma or cigarette smoking be vaccinated with Pneumococcal vaccine~     (PPSV23). The purpose of this study is to increase awareness of vaccination to late~     adolescents with asthma and smokers (social aspect of study), and to recommend vaccination~     (which is the clinical aspect). Individuals who agree to receiving vaccine will be enrolled~     in research to determine whether late adolescents with and without asthma (smokers) have~     distinctive pneumococcal vaccine response patterns and whether such patterns are associated~     with subsequent variance in asthma outcomes.~   "
64756|NCT02719340|"~     Although long-segment posterior spinal fixation might provide more rigid fixation, the~     procedure increases perioperative morbidities in the elderly. The present study reviews the~     results of short-segment decompression and reconstruction in thoracolumbar fragile fractures.~   "
64757|NCT02719327|"~     The number of Americans diagnosed with Alzheimer's disease (AD) is expected to triple by~     2050. Compared to the general population, Veterans have a greater risk of AD, likely in part~     due to their increased incidence of traumatic brain injury, post-traumatic stress disorder,~     depression, and other vascular-related health issues. Based on available data, 423,000 new~     cases of AD are anticipated in Veterans by 2020. Thus, the discovery of effective therapies~     to prevent or delay the onset of AD in Veterans is critical. The goal of this study is to~     evaluate the efficacy of a purified form of the omega-3 fatty acid eicosapentaenoic acid~     (EPA) called icosapent ethyl (IPE), on improving brain blood flow, spinal fluid markers of AD~     pathology, and cognitive performance in middle-aged, cognitively-healthy Veterans with~     increased risk of AD. If IPE delays the onset of AD by even 5 years, the incidence of AD~     would be reduced by 50% in this population and could have a profound effect on Veteran~     quality of life and healthcare costs.~   "
64758|NCT02719314|"~     Glucocorticoids remain to be among the most important and most frequently used~     anti-inflammatory and immunosuppressive or immune-modulatory acting drugs to treat rheumatic~     (and other) diseases. Unfortunately, glucocorticoids also exert undesired effects, especially~     if higher dosages have to be given over longer periods of time. The available data describing~     frequency and severity of these adverse effects are fragmentary. This statement is especially~     true for glucocorticoid-induced osteoporosis (GIOP) in the context of chronic inflammatory~     rheumatic diseases or (in part) psoriasis(arthritis). The state of knowledge and scientific~     data, being sparse, is partly conflicting and often derived from over-aged projects or~     studies. Therefore, there are urgent needs to work on various current questions~     systematically and at the highest scientific level possible. In order to address these needs,~     we aim at collecting and analyzing disease- and bone-related data from patients with chronic~     inflammatory rheumatic diseases or psoriasis and therapy with glucocorticoids, and to build a~     respective GIOP-Databank. Patients will attend for diagnostics, and where necessary therapy~     and follow-up of GIOP, according to current guidelines. Clinical, laboratory and instrumental~     examination results from more than 1000 patients in the first three years of the project are~     planned to be documented in a prospective database.~   "
64759|NCT02719301|"~     Study will compare measurements made with Necklace device for stroke volume/cardiac output~     with values from a FDA-approved reference device. The gold standard that will be used is~     Cardiac MRI. Subjects will be measured with both the Necklace, reference device, and the~     Cardiac MRI. Values calculated by the Cardiac MRI analysis will be compared with the~     reference device and the Necklace.~   "
64760|NCT02719288|"~     Peroneal and Achilles tendon tears are common diseases that present challenges to surgeons~     due to tendon adhesion complications. Functional recovery is compromised by limiting~     post-operative range of motion, mobility, and can lead to considerable amount of~     post-operative pain for the patient.~      Amniotic membrane tissue has demonstrated clinical success as an anti-inflammatory and~     anti-scarring agent and promoting wound healing towards regeneration.~      Cryopreserved human amniotic membrane and umbilical cord (AM/UC) tissue in the form of~     CLARIX® CORD 1K has been used to treat over 5000 orthopedic patients. The investigators~     hypothesize that its use in peroneal and Achilles tendon surgical repair will enhance the~     overall functional recovery of the patient.~   "
64788|NCT02718924|"~     Investigators hypothesized that the impact of surgery in terms of inducing a hypercoagulable~     state is more evident in morbidly obese pregnant women as opposed to their non-obese~     counterparts. The aim of this study is to investigate the change in coagulation status of~     morbidly obese and non-obese pregnant women following cesarean section delivery using~     thromboelastometry. This observational study would also make it possible to calculate the~     sample size for a future prospective controlled clinical trial to compare the incidence of~     Hypercoagulability in morbidly obese parturients as opposed to their non-obese counterparts.~     To the best of our knowledge, no other work has been done any in this area.~   "
64761|NCT02719275|"~     Suicide is the 2nd leading cause of death for teenage youth in Canada, and every year tens of~     thousands of young people engage in suicidal behaviors. Many young people manifest red-flag~     behaviors in the digital realm before these incidents occur. The faceless nature of online~     communication often emboldens youth to reveal details about their mental state: leaving~     tell-tale signs or bread crumbs of their suicidal intentions or behaviors.~      This research will examine the content of adolescents social media entries to find red flags~     and detect patterns in social media interactions of adolescents that could be predictive of~     subsequent suicide risk. The study participants will be patients admitted to Child and~     Adolescent Psychiatry Emergency unit at BCCH, subdivided into two groups: those admitted due~     to suicidal behaviors, and those admitted for non-suicidal behaviors. The text of social~     media activity for the month prior to emergency admission of the two groups will be~     collected, anonymized, and analyzed using text-analytic algorithms. The objective of the~     study is to find patterns and indicators of social media entries, prior to admission, that~     would have been predictive of suicidality.~      The implications of successful outcome of this project for mental health care of children and~     adolescents reaches well beyond the scope of this study. An objective method to predict risk~     of suicidal behaviors in youth has application in almost all pediatric clinical settings. The~     outcomes of this project will also serve as the foundation for further utilization of social~     sensing technology to identify, predict, and prevent many other mental health crises in~     children and adolescents.~   "
64762|NCT02719262|"~     The investigators recent study has found that ambient melamine exposure can cause the~     increase of biomarkers of renal tubular injury in melamine manufacturing workers. Thus, in~     this year, the investigators will examine whether the intervention by installing ventilation~     in the workplace and providing personal protective equipment and education can decrease~     ambient melamine exposure and further decrease urinary biomarkers of renal tubular injury~     such as N-acetyl β-D-glucosaminidase (NAG) and β2-microglobulin (β2-MG).~   "
64763|NCT02719249|"~     Screening of Fabry disease in end-stage renal disease (ESRD) patients on dialysis or~     transplant in west of France.~   "
64764|NCT02719236|"~     The purpose of this study is to compare the direct anterior approach and the direct lateral~     approach in primary total hip arthroplasty, regarding the postoperative function and pain,~     complications, radiological finds (X-ray), postoperative hemorrhage, markers for muscle~     damage (i.e creatine kinase (CK), lactate dehydrogenase(LDH/LD) , aspartate~     aminotransferase(AST), C-reactive protein (CRP),Troponin and Myoglobin) or other clinical~     outcomes.~   "
64765|NCT02719223|"~     Rationale and objectives~        1. Patients on On Line Hemodiafiltration (OL- HDF) are more stable hemodynamically with~          less Intra Dialytic Hypotension (IDH) episodes compared to conventional hemodialysis~          (HD). The investigator will follow the hemodynamic parameters during the dialysis~          sessions (HD and OL-HDF) by using the new non invasive technology, the NICAS device.~        2. By switching each patient with IDH from HD to OL- HDF, the investigators will evaluate~          the hemodynamic parameters and compare the two renal replacement treatment modalities,~          and prove the superiority of OL-HDF over HD regarding the hemodynamic measures.~   "
64766|NCT02719210|"~     All the children with acute liver failure who are candidates for transplant but have~     constraints for transplant will be randomized either to receive standard medical therapy or~     high volume plasma exchange along with standard medical therapy with the aim to assess the~     effect of high volume plasma exchange on transplant free survival.~   "
64767|NCT02719197|"~     The primary purpose of this first-in-man study is to investigate whether a new drug for~     neurological disorders is safe and well-tolerated when administered orally to healthy male~     adults~   "
64768|NCT02719184|"~     The study will include 60 healthy subjects (ex-smoker without any airflow limitation), 125~     COPD GOLD (global initiative for chronic obstructive lung disease) I , 125 COPD GOLD II, 125~     COPD GOLD III and up to 20 patients with COPD and A1AT (Alpha1-Antitrypsin) deficiency (ZZ~     genotype). Soluble and imaging biomarkers will be investigated addressing different aspects~     of disease pathways postulated to be relevant for COPD progression.~   "
64769|NCT02719171|"~     The overall purpose of this trial is to assess clinical efficacy and safety of different~     subcutaneous doses of BI 655066/ABBV-066/risankizumab in adult patients with psoriatic~     arthritis in order to select doses for further clinical trials.~   "
64770|NCT02719158|"~     This is a 1-month, prospective, multicenter, randomized, dose-ranging, sham-controlled,~     blinded study in which eligible subjects with either unilateral or bilateral acute otitis~     media with tympanostomy tubes (AOMT) will receive a single administration of 6 mg OTO-201, 12~     mg OTO-201, or sham into the affected ear(s).~   "
64771|NCT02719145|"~     This cross sectional study will be carried out on 30 subjects who will be recruited from the~     outpatient clinic of Chest Department, Tanta University Hospital.~      They will be classified into 3 groups:~      Group I: It will include 10 healthy volunteer subjects. Group II: It will include 10~     asthmatic patients. Group III: It will include 10 COPD patients. miR-7, miR-20a, miR-21,~     miR-22, miR-145 and miR-155 will be measured in serum samples from all subjects~   "
64772|NCT02719132|"~     This is a multicenter, randomised, open-label, crossover, 2-period comparative phase IV~     study.~      The primary objective is to compare the effect of dapagliflozin 10 mg once daily in~     combination with metformin at a daily dose of ≤1,500 mg vs. metformin monotherapy with dose~     titrated up to 2,500 mg/day on the overall quality of life, obesity-specific quality of life~     and treatment satisfaction in patients with type 2 diabetes.~   "
64773|NCT02719119|"~     Many physicians suggest repeating EVL every 1-2 weeks until esophageal varices are~     obliterated to prevent variceal rebleeding， however, the evidences supporting the efficacy of~     EVL intervals of 1-2 weeks are insufficient.This randomized controlled study was conducted in~     order to compare the long-term results of EVL when performed at two different results from~     monthly and bi-weekly treatments.~   "
64774|NCT02719106|"~     The purpose of this study is to evaluate the relative effectiveness and safety of Ultimaster~     stent compared to other drug eluting stents.~   "
64789|NCT02718911|"~     The main purpose of this study is to evaluate the safety of the colony-stimulating factor 1~     receptor (CSF-1R) inhibitor LY3022855 in combination with durvalumab or tremelimumab in~     participants with advanced solid tumors.~   "
64790|NCT02718898|"~     The main purpose of this study is to evaluate the efficacy and safety of the study drug~     ixekizumab compared to placebo in participants with moderate-to-severe genital psoriasis.~   "
64775|NCT02719093|"~     Two common SNPs are located in linkage disequilibrium in exon 10 of FSHR. The 2039 A>G~     variant is regularly analyzed to characterize the exon 10 haplotype. In the last years, it~     has been showed an influence of FSHR 2039 A>G on FSH levels, testicular volume, sperm~     concentration and the total sperm count. A recent Cochrane review showed a beneficial effect~     on live birth and pregnancy of gonadotrophin treatment for men with idiopathic male factor~     subfertility. Which FSHR polymorphism can benefit from FSH treatment is clinically very~     important, in particular for what regards nonidiopathic patients. In many andrological units,~     patients underwent adiuvant therapy with purified or recombinant FSH after varicocelectomy.~     FSH treatment in patients after varicocelectomy could improve spermatogenesis, but there~     aren't multicentric trials that confirm its validity. Usually, in our hospital only patients~     with a morphologic aspect of hypospermatogenesis underwent therapy with purified or~     recombinant FSH, because this therapy is not much useful in patient with Partial~     Sertoli-cell-only syndrome or maturation arrest. The purpose of our study is to correlate~     non responder patients who underwent FSH adiuvant therapy after varicocele surgery with a~     p.N680S FSHR polymorphism. Moreover the investigators suppose that non responder patients~     can beneficiate from a high-dose therapy with FSH. This is a prospective intervention study~     in which are recruited males with OligoAstenoTeratozoospermic (OAT) and varicocele. The~     partecipants will undergo subinguinal microsurgical varicocelectomy (Marmar technique) and~     needle aspiration testicular cytology (Foresta technique).~   "
64776|NCT02719080|"~     This study was designed to observe the cerebral state obtained via wavelet analysis~     (HXD-I,Beijing Easymonitor Technology Co.Ltd, China) and evaluate the emotion in various~     states in anesthesiologist and surgeon. And we also explore the association between the~     characteristic of cerebral state and the emotion.~   "
64777|NCT02719067|"~     The significance of this project is the first longitudinal study to investigate the changes~     of neurocognitive functions of children and adolescents with ASD and to identify the~     potential neuroimaging endophenotype (biomarkers) for ASD in Asian with advanced imaging~     technique (Tract-based automatic analysis, TBAA; multi-echo resting-state fMRI in addition to~     single-echo resting-state fMRI). The success of this project will fill the gap of our~     understanding of longitudinal changes of brain function by neuropsychological and imaging~     approaches of ASD in Han Chinese in Taiwan, and is anticipated to facilitate the progress of~     translational research in ASD.~   "
64778|NCT02719054|"~     Investments in Early childhood Development (ECD) programs produce higher economic return~     through maximizing human potential. In developing countries over 200 million children do not~     reach their developmental potential. Early nutritional support and psycho social stimulation~     are essential for optimum development of children. Mothers are usually the key providers of~     childcare.~      Depression is reported as a leading cause of disease burden for women and maternal mental~     health is identified as one of the major predictors of child development.~      In Bangladesh, almost 60% children are at risk of poor development due to high prevalence of~     Low Birth Weight (22%), under nutrition (41%), poverty, and sub-optimal stimulation. About~     one third of Bangladeshi mothers suffer from depression. Early stimulation interventions in~     Bangladesh have showed moderate improvements to children's development. This indicates that~     there are still some gaps in the pathway to delivery. So, it is crucially important to~     address maternal mental health along with any Early Childhood Development intervention at~     community level to get bigger impact.~      In Bangladesh mothers with sub clinical depressive symptoms often do not seek treatment due~     to the stigma attached to it. Depressed mothers who do not receive treatment often fail to~     provide sufficient stimulation and care for their children and in turn compromise benefits of~     early stimulation programs. Rahman and colleagues (2008) tested an innovative model of~     community-based depression management using Cognitive Behavioral Therapy in Pakistan and~     reported improvement in maternal depression 6 months postpartum.~      The study plans to combine the above treatment of depression with an evidenced-based Early~     Childhood Development program to achieve maximum benefits on reducing maternal depressive~     symptoms as well as improving children's overall development.~   "
64779|NCT02719041|"~     The main goal of this study is to employ a novel proteomic approach to identify predictive~     tumor biomarkers that will increase the efficacy of insulin-like growth factor (IGF1R)~     targeted therapy in epithelial ovarian cancer. It is expected that these predictive~     biomarkers will be applied to increase the response rate in selected groups of patients.~   "
64780|NCT02719028|"~     Identified the efficacy of Antroquinonol (Hocena 50mg) in triglyceride, lipid-lowering and~     fatty liver.~   "
64781|NCT02719015|"~     The goal of this clinical research study is to find the highest tolerated dose of rAd.CD40L~     (also called ISF35) when given with pembrolizumab to patients with melanoma. Researchers also~     want to learn if the highest tolerated dose of ISF35 and pembrolizumab can help to control~     the disease.~      The safety of this drug combination will be also be studied.~   "
64782|NCT02719002|"~     Maculopathy induced by retinal toxicity of synthetic antimalarials is to be screened at the~     sub-clinical stage. Indeed, when the first visual symptoms appear, macular damage is already~     irreversible and the clinical picture may even continue to deteriorate for several years~     after the end of synthetic antimalarial use. In opposition, the early termination of~     hydroxychloroquine in patients showing recent alterations on the multifocal electroretinogram~     (nfERG) allowed he reversibility of toxic damage over a six month period. It is therefore~     critical to detect early retinal anatomic changes during retinotoxicity screening before the~     occurrence of irreversible anatomical and functional consequences.~      The usual patient monitoring consists of an annual eye examination, detecting subjective~     functional abnormalities (visual acuity, color vision, central visual field testing) or~     macular lesions (eye fundus). These abnormalities show a constituted infringement and do not~     contribute to the early diagnosis of synthetic antimalarial maculopathy.~      The mfERG is an objective examination, able to detect retinal damage whilst still reversible.~     It is recommended during the annual monitoring and is, today, the gold standard for the~     screening and diagnosis of synthetic antimalarial maculopathy. However, its realization is~     time consuming, requires a good patient cooperation and is difficult to access due to the few~     ophthalmology centers offering it. In practice, it is rarely done as a systematic annual~     screening for patients on long-term synthetic antimalarial treatment. It is often limited to~     second-line studies (for patients already showing functional or anatomical abnormalities)~     whereas its interest lies in the detection of early lesions.~      The Optical Coherence Tomography Spectral Domain (OCT-SD) is a non-invasive eye examination,~     commonly used since nearly 10 years. A special image analysis provides a panoramic viewing of~     the state of the photoreceptor layer, and a non-invasive detection of any anatomical changes,~     even subtle, within this layer.~      The concordance between the en face OCT and the mfERG in the screening of synthetic~     antimalarial maculopathy is considered in this study.~   "
64783|NCT02718989|"~     The purpose of this study is to determinate whether the application of electric currents~     produce changes in the excitability of alpha moto neurone. Moreover evidence whether the~     effect of the electric currents can change the tone of the muscle under stimulation in~     healthy volunteers~   "
64784|NCT02718976|"~     The main objective is to complete a double-blinded randomized controlled crossover trial of~     lumbar plexus block with the Shamrock technique guided by ultrasound (US)/magnetic resonance~     imaging (MRI) image fusion vs. the Shamrock technique guided by ultrasound in healthy~     volunteers.~      The investigators will assess block procedure-related parameters, anatomical spread of local~     anesthetic, and motor and sensory effects.~   "
64785|NCT02718963|"~     The purpose of this study is to determine the synchronized electrical stimulation device~     effective in the treatment of dysphagia.~   "
64792|NCT02718872|"~     This project is responsive to the identified gap of lack of tobacco cessation training~     programs in Latin American & Caribbean countries. Currently, smoking rates in the Latin~     American and Caribbean region are high, and previous surveys show that health professionals~     do not have enough skills to help smokers to quit. In consequence, in absence of trained~     health professionals, many smokers who visit health care services are under-treated. The~     Fruitful Project aims to adapt an original on-line course developed in Spain to the reality~     of the three Latin American countries (Bolivia, Guatemala and Paraguay) and disseminate~     evidence-based tobacco cessation interventions among health care professionals.~   "
64793|NCT02718859|"~     The purpose of this study is to evaluate the safety and efficacy of the combined therapy~     using irreversible electroporation（IRE）and nature killer(NK) cells for advanced pancreatic~     cancer.~   "
64794|NCT02718846|"~     A multicenter, randomized, open-label clinical study with a concurrent control group to~     assess the effectiveness and safety of combined therapy with Isobide solution and Meniace~     tablets compared to monotherapy with Meniace tablets for patients with Meniere's disease~   "
64795|NCT02718833|"~     This research study is studying a combination of study drugs as a possible treatment for~     relapsed and refractory Multiple Myeloma. The interventions involved in this study are~     elotuzumab, pomalidomide, bortezomib, dexamethasone.~   "
64796|NCT02718820|"~     Squamous cell carcinoma of the head and neck, which accounts for 90% of head and neck~     cancers, is the tenth most common cancer worldwide with over 650000 new cases per year. The~     major risk factors for HNSCC development comprise alcohol and tobacco consumption. During the~     last decades human papilloma virus infection (HPV) has been identified to contribute to the~     development of oropharyngeal HNSCC in a subgroup of patients5. Standard treatment options~     include surgery, (chemo)radiation and chemotherapy. Despite improvements of treatment~     regimens the recurrence rate of stage III/IV disease after curative therapy is about 30-40%.~     In locoregionally unresectable recurrent or metastatic disease palliative poly-chemotherapy~     is the mainstay of therapy.The median survival time of these patients is 6-8 months. Based on~     the results of the EXTREME study a combination regimen containing a platinum drug, 5~     fluorouracil (5-FU) and weekly cetuximab has become standard of care in this setting. For~     patients, who progressed after platinum based therapy, treatment options are scarce. Besides~     platinum drugs, taxanes such as paclitaxel or docetaxel were shown to be of particular use in~     this setting. Apart from that there has been increasing preclinical and clinical evidence~     that immune-checkpoint inhibitors such as pembrolizumab might play a role in HNSCC. Thus, it~     is the aim of this study to test if the combination of docetaxel and pembrolizumab after~     platinum failure is an effective and safe regimen.~   "
64797|NCT02718807|"~     Pre-made rapid prototyping models will be used to increase patient education versus current~     methodologies.~   "
64798|NCT02718794|"~     Teaching and learning of difficult airway management are considered to be an essential skill~     in anesthesiology. As a result, doctors and nurses in anesthesia have to be vigilant in every~     step including airway assessment, equipment preparation and strategic planning of the~     process.~      During the one-year training program, nurse anesthetist students intensively study theories~     and practical skills in anesthesia, using manikins to living patients. Difficult airway~     management has become a distinguished means in the training curriculum. In addition, the~     educational tool in the anesthesia curriculum is typically simulation-based learning (SBL)~     and problem-based learning (PBL) courses. As a result, we designed a cross-over study to~     determine the learning achievement of nurse anesthetist students in difficult airway~     management. The objectives were to study the learning achievement and relative growth of~     knowledge of the two learning techniques: SBL and PBL.~      Thirty-six nurse anesthetist students in Academic Year 2015, volunteered to join the study~     project. After signing the consent form, they were randomly put into two groups: A (n = 17)~     and B (n = 19). As designed by the cross-over study, students in group A attended SBL and~     after 6 weeks, they focused on PBL, and vice versa for group B.~      The 40-item, multiple choices exam was developed in regard to difficult airway management~     guidelines. The correctness and appropriateness of the test (content validity) were~     determined by three board-certified anesthesiologists. The try out of the test was performed~     by 10 novice nurse anesthetists. The index of item objective congruence was 0.82 with Kuder~     Richardson 21 of 0.8. The assessed criterion-referenced item difficulty and discrimination~     index were 0.4-0.6 and 0.6-0.8 respectively.~      The pretest (X1, X2) were post-test ((Y1, Y2) were performed in the consequence. The relative~     growth of knowledge (G1, G2) was calculated as follows:~      G1 = 100 (Y1 - X1) / (F - X1) % G2 = 100 (Y2 - X2) / (F - X2) %~      Where F was the full scores of the learning course~      Statistics analysis The test scores and relative growth of knowledge between the two groups~     were expressed as mean and standard deviation. Comparison between the two groups was~     performed by repeated measure ANOVA. Statistically significant differences were considered~     when there was a p value of < 0.05 with a 95% confidence interval.~   "
64799|NCT02718781|"~     In recent years, Hong Kong has been undergoing rapid changes with macro social and economic~     trends. The increasingly complex and diverse family structure contribute to concerns~     regarding the well-being of families in Hong Kong, including their health, happiness and~     harmony (FAMILY 3Hs). Family life and health education should be strengthened to meet the~     increasing needs of promoting healthy active lifestyle among Hong Kong families. In this~     connection, the FAMILY Project initiates the Fitter Families Project (FFP) with a focus on~     FAMILY Holistic Health, will be conducted in order to increase the awareness of the~     importance of FAMILY 3Hs. FFP is a community-based research project with 3 main components -~     train-the-trainers programs, community-based family interventions and public education~     events. It is expected that trainees from the train-the-trainers programs will acquire~     adequate skills to organize community-based health education programs effectively.~     Participants of the community-based family interventions will gain knowledge on family~     holistic health and live a healthy active lifestyle. Attendees of the public education events~     will become more aware of the importance of FAMILY 3Hs.~   "
64800|NCT02718768|"~     This is a multi-center prospective observational study that will capture detailed information~     about the treatment and long term outcomes of 450 patients with PNI resulting from upper~     extremity trauma. The study will focus on a young adult population to include individuals~     ages 18-65. Patients with PNI will be recruited during the hospitalization for initial~     treatment of the upper extremity injury. Additional patients may be identified during clinic~     visits for on-going treatment of upper extremity injuries as nerve injuries evolve or upon~     referral from outside physicians. However, all eligible nerve injuries must be treated within~     6 months of the initial upper extremity trauma. Outcomes will be assessed at 3, 6, 12, 18 and~     24 months following diagnosis of the nerve injury. All assessments will take place in the~     clinic and will include a patient interview and a brief exam to evaluate sensory and motor~     function.~   "
64801|NCT02718755|"~     The goal of this clinical research study is to learn if fludarabine, cytarabine (ARA-C), and~     erwinase (also known as asparaginase [erwinia]) in combination can help to control relapsed~     or refractory hematologic malignancies. The safety of these drugs will also be studied.~   "
64803|NCT02718729|"~     Anastomotic leak (AL) is a breakdown of a suture line in a surgical anastomosis with a~     subsequent leakage of the luminal content. Anastomotic leakage occurs commonly in rectal and~     esophageal anastomosis than the other parts of the alimentary tract due to technical~     difficulties in accessing these areas and their easily compromised blood supply.~      Anastomotic leakage is the most feared complication following rectal resection and~     anastomosis. The incidence of anastomotic leakage ranges from 2.8% to more than 15%, with~     mortality rate more than 30%. Subclinical anastomotic failure may occur in up to 51% of~     patients.~      Anastomotic leakage leads to increase the rate of secondary interventions, re-operations,~     longer postoperative hospital stay, increased cost, and major impact on the patient's quality~     of life. In the medium to long term, patient may be unfit for post-operative adjuvant therapy~     with decreased the disease survival. Furthermore anastomotic leakage itself may increase the~     local recurrence, a reduction in overall survival, and a large proportion of patients are~     left with a permanent stoma.~   "
64804|NCT02718716|"~     The primary objective of the study is to check if an subcutaneous (sc) infusion of UCB7665 is~     safe and tolerated in subjects with primary immune thrombocytopenia.~   "
64805|NCT02718703|"~     Clinical Evaluation including System Accuracy, User Performance and System Use Evaluation of~     a new Blood Glucose Monitoring System.~   "
64806|NCT02718690|"~     The purpose of this study is demonstrate the importance of density current of TENS in the~     effect about H-reflex in healthy volunteers.~   "
64807|NCT02718677|"~     This NIS aims to evaluate the efficacy and the safety of ReFacto AF in the Standard~     Prophylaxis Treatment of children with severe hemophilia A in Romania~   "
64808|NCT02718664|"~     Healthy volunteer food-effect study to determine the effect of food on uracil and~     dihydrouracil levels in plasma~   "
64809|NCT02718651|"~     Genetic rearrangements in the Anaplastic Lymphoma Kinase (ALK) gene result in the creation of~     a variety of oncogenic fusion proteins that drive malignancy in a subset of non-small cell~     lung cancers (NSCLC) patients. Treatment with the ALK small tyrosine kinase inhibitor (TKI)~     crizotinib has produced remarkable results for ALK-positive patients, however the current~     diagnostic tests used in the clinic are not sufficiently detailed and require a tumor biopsy.~      The aim of this study is to use a new diagnostic test to detect ALK rearrangements using next~     generation sequencing, which will improve the diagnosis and treatment of ALK-positive NSCLC~     patients. Furthermore, this test will be performed on blood samples, making it minimally~     invasive for the patients. It is our believe that circulating tumor DNA (ctDNA) in blood can~     be employed as an easy accessible and comprehensive source of information to diagnose~     ALK-positive disease, but also as a means of monitoring patient response during treatment.~     Quantitation of the the amount of ALK rearrangement will give information about which~     patients benefit from treatment and when treatment is no longer effective. The project will~     be a multicenter study where blood samples will be collected every 6 weeks from patients~     treated at four major hospitals in Denmark.~      This study will benefit future patients with lung cancer, as it will improve both the~     monitoring and evaluation of their treatment. Monitoring patients during treatment will~     provide more knowledge of disease progression and the effect of ALK-TKI treatment,~     contributing to a greater selection of patients, who will respond to treatment. This will~     potentially allow effective treatment to continue longer than with conventional methods~   "
64810|NCT02718638|"~     Oxidative stress and inflammation are cardiovascular risk factors in patients with chronic~     kidney disease (CKD) undergoing hemodialysis (HD). Nuclear transcription factors play roles~     in the coordinated expression of genes involved in inflammation, such as nuclear factor Kappa~     B (NFkB) that increase the cytokines synthesis and Nuclear factor erythroid 2-related factor~     2 (Nrf2) that increase the transcription of genes encoding enzymes of phase II detoxifying~     and antioxidant enzymes. The aim of this study was to evaluate the effects of resistance~     exercise program on the expression of transcription factors Nrf2 and NF-kB in HD patients.~   "
64811|NCT02718625|"~     This study is designed to compare SANTYL® versus hydrogel (SoloSite®) in the treatment of~     pressure ulcers for participants in a long-term care facility. After meeting study criteria,~     participants will be randomly assigned for application of SANTYL® or SoloSite® to their~     pressure ulcer for up to 6 weeks. A study previously conducted showed that in the long-term~     care setting, the removal of dead skin (debridement) with SANTYL® resulted in more~     participants achieving complete debridement, more rapidly than when SoloSite® is used. The~     goal of the present study is to confirm the results of the earlier study, demonstrating~     superior debridement outcomes for pressure ulcers of patients in long-term care as compared~     to ulcers managed with SoloSite®.~   "
64812|NCT02718612|"~     Uraemic sarcopenia is complex, and progressive . As older persons are particularly~     susceptible to renal failure and this accelerates the physiological muscle wasting in this~     patient group. Hence sarcopenia is an important factor of functional impairment in elderly~     patients suffering from chronic kidney disease. On the other hand, overweight has become~     increasing common in dialysis patients, and is paradoxically reported to be associated with~     better survival. It remains unclear if adipose tissue in overweight in elderly dialysis~     patients is a source of proinflammatory mediators, which could contribute to protein-energy~     wasting (PEW), cardiovascular disease, and increased mortality. This study attempts to~     explore the prevalence of Sarcopenic Obesity (SO) in a cohort of hemodialysis patients with a~     more well defined criteria. In addition, this study aims to examine the association between~     sarcopenia and SO with metabolic and cardiovascular risk factors in these patients.~   "
64813|NCT02718599|"~     To evaluate the effect of terlipressin infusion on systemic and hepatic hemodynamics during~     hepatobiliary surgery~   "
64814|NCT02718586|"~     The aim is to test if serum level of myokines are associated with protein energy wasting,~     inflammation and atherosclerotic vascular disease among Taiwanese dialysis patients. Some~     novel myokines levels, anthropometric parameters, cardiovascular risk factors, and presence~     of endothelial dysfunction will be examined in 250 subjects. The distribution of some~     recently identified myokines such as irisin, myotatin etc levels will be studied and~     correlated markers of malnutrition, endothelial dysfunction, inflammation and insulin~     resistance. In the present study, the investigators will further follow and investigate~     whether serum myokines levels are associated with long-term mortality from all causes and~     from cardiovascular disease.~   "
64815|NCT02718573|"~     The objectives of the study are to determine the impact of interferon-free treatment for the~     hepatitis C virus (HCV) on peripheral blood immune cell phenotype and soluble immune-related~     proteins in blood, while controlling for genetic polymorphisms known to impact HCV-related~     immune responses, and to determine the impact of the therapy on the emergence of~     drug-resistant HCV. The study design is informed by the researchers recent investigations of~     patients receiving HCV treatment. About 4% of patients who had not undergone liver~     transplantation experienced hepatic decompensating or another serious event. There were~     several cases of bacterial infection and two cases with elevated markers of autoimmune~     processes. These events suggest that treatment altered immune responses. About 25% of~     patients who had undergone liver transplantation experienced hepatic decompensating or~     another serious adverse event. The long term goal is to understand the pathophysiology of~     these complications and determine whether HCV treatment can cause an immune reconstitution~     syndrome in susceptible patients, while improving antimicrobial defenses in others~   "
64816|NCT02718560|"~     The aim of the study is to evaluate the efficacy of an intensive handwriting treatment in~     Parkinson's Disease.~   "
64817|NCT02718547|"~     The Investigators propose to examine the effect of lowering the intraocular pressure on~     macular edema in Participants diagnosed with diabetic macular edema. Our theory is based on~     the assumption that lower intraocular pressure means higher Ocular Perfusion pressure, which~     may cause an improvement in retinal perfusion and thus an improvement in retinal oxygenation~     and reduced edema~   "
64818|NCT02718534|"~     This study aimed to evaluate effectiveness of initial limb rehabilitation compare therapy~     took place within 48h with therapy took place after 48h for patients with stroke (modified~     Rankin Scale Score 3-4).~   "
64819|NCT02718521|"~     Patients at moderate and high risk for contrast induced nephropathy (CIN) should receive~     sufficient hydration before application of contrast to prevent CIN, but hydration could~     obviously increase the preload for congestive heart failure (CHF) patients. Isosorbide~     Dinitrate could reduce cardiac preload and afterload by expanding vein and artery.so adequate~     hydration therapy combined with intravenous infusion of isosorbide dinitrate could better~     prevent contrast-induced nephropathy theoretically.This prospective, randomized,~     double-blind, comparative clinical trial randomly selected 264 patients with estimated~     glomerular filtration rate, (eGFR) <60 ml/min per 1.73 m2 and CHF undergoing coronary~     angiography to receive either the convention hydration (n=200) or the hydration therapy~     combined with intravenous infusion of isosorbide dinitrate(n=200).~   "
64820|NCT02718508|"~     The objective of this trial is to test feasibility and acceptability of an e-parenting skills~     intervention with parents of injured adolescent alcohol users (12-17 years old) as compared~     to standard care at three pediatric trauma centers. To examine these questions, the~     investigators will randomly assign adolescent and parent dyads (up to 75) to one of two~     groups. One group will continue to receive the institutional standard care of a brief alcohol~     intervention delivered by clinical staff to the adolescent with no parenting skills~     intervention. The second group will continue to receive the same institutional standard care~     plus the parent will receive an e-parenting skills intervention consisting of: the online~     parent training program, Parenting Wisely(PW), plus text messaging and a web-based message~     board. Study participants will be injured adolescents, 12-17 years old, admitted to the~     inpatient service of the trauma center, and with a positive CRAFFT (mnemonic acronym of first~     letters of key words in the screening tool) screen for alcohol use. Adolescents' alcohol use~     will be measured at study enrollment and at 3 and 6 months after discharge. Adolescents'~     alcohol related negative consequences will be measured at study enrollment for the 6 months~     prior to hospitalization and again at 6 months after hospital discharge. Parenting skills~     will also be assessed at 3 and 6 months.~   "
64821|NCT02718495|"~     This trial will consist of three arms: Part A, Part B, and Part C. Part A has two groups. The~     first group will enroll adult subjects with cystic fibrosis (CF) into a single ascending dose~     (SAD) treatment group. The second group will enroll adult subjects with CF, including those~     on background treatment with ORKAMBI® and those not on a cystic fibrosis transmembrane~     conductance regulator (CFTR) modulator, into a multiple ascending dose (MAD) treatment group.~     Part B will enroll adult subjects with CF currently on stable ORKAMBI® background therapy for~     a minimum of 3 months into a Phase II treatment group consisting of two cohorts. Part C will~     enroll adult subjects with CF, including those on background treatment with KALYDECO® and~     those not on a CFTR modulator, into a Phase II treatment group consisting of three cohorts.~     Approximately 136 subjects will be enrolled.~   "
64822|NCT02718482|"~     Phase II randomized study for the comparison of the Gemcitabine plus Docetaxel and the~     Ifosfamide treatment of patients with relapsed osteosarcoma~   "
64823|NCT02718469|"~     The purpose of this study is to assess the safety profile of the Zaire Ebola vaccine and the~     strength of the immune response.~   "
64824|NCT02718456|"~     The study will evaluate interventions to improve engagement in HIV care following HIV~     diagnosis through a voluntary counseling and testing program. The specific aims are to (1)~     determine if a VCT-based intervention of CD4 count testing, alone or in combination with peer~     counseling, improves linkage to HIV/AIDS care; (2) assess the impact of the intervention on~     ART initiation. The study will recruit 450 HIV-positive individuals from VCTs and randomize a~     third to standard counseling and referral, a third to receive CD4 testing at the VCT with~     results return by phone after 1 weeks, and a third to receive the same CD4 testing combined~     with peer counseling. These combined investigations will create a comprehensive understanding~     of obstacles to appropriate HIV/AIDS care and result in new interventions to achieve~     measurable outcomes in applied settings.~   "
64825|NCT02718443|"~     VXM01 phase I pilot study in patients with operable recurrence of a glioblastoma to examine~     safety, tolerability, immune and biomarker response to the investigational VEGFR-2 DNA~     vaccine VXM01~   "
64826|NCT02718430|"~     Phase I study in patients with metastatic colorectal cancer with liver metastasis under~     second or third line therapy to examine safety, efficacy, and immune biomarkers after~     treatment with VXM01~   "
64853|NCT02718079|"~     The study will be conducted on patients admitted to Department of Hepatology from Jan 2016 to~     Jan 2018 at Institute of Liver & Biliary Sciences, New Delhi. Study group will comprise of~     patients with acute liver failure (ALF) who have no option for liver transplant (due to any~     reason) or have contraindications for liver transplant or have no prospective living donor~     and will be assessed for enrollment in the trial.~   "
64827|NCT02718417|"~     This is a Phase 3, open-label, international, multi-center, efficacy, and safety study of~     avelumab in combination with and/or following platinum-based chemotherapy. Eligible patients~     must have previously untreated, histologically confirmed Stage III-IV epithelial ovarian~     (EOC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) and be candidates for~     platinum-based chemotherapy.~      The primary purpose of the study is to demonstrate if avelumab given as single agent in the~     maintenance setting following frontline chemotherapy or in combination with~     carboplatin/paclitaxel is superior to platinum-based chemotherapy alone followed by~     observation in this population of newly diagnosed ovarian cancer patients.~   "
64828|NCT02718404|"~     The purpose of this study is to evaluate the effectiveness of the Philips Sonalleve 3 Tesla~     MR-HIFU device for treating painful bone metastases.~   "
64829|NCT02718391|"~     This phase II, randomized, open-label trial aims to assess whether the vaccination increase~     RFS in disease free melanoma patients after surgery. Patients will be randomized between~     Intradermal Autologous Dendritic Cell Vaccine loaded with autologous tumor lysate or~     homogenate (6 vaccines every 4 weeks) and observation.~   "
64830|NCT02718378|"~     The current study is designed as a phase Ib multiple dose study to evaluate the safety,~     tolerability, pharmacokinetics and pharmacodynamics of E4 in healthy men after daily oral~     administration for 28 days.~   "
64831|NCT02718365|"~     The purpose of this study is to evaluate whether the long-term outcome and safety of wedge~     resection are comparable to segmentectomy for the surgical treatment of early stage (IA)~     non-small cell lung cancer (NSCLC). Zhang et al. performed a meta-analysis of 53 studies and~     suggested that sublobectomy achieved a survival rate comparable to lobectomy in a selected~     population of patients with Stage I NSCLC. However, one critical question needs to be~     addressed, that is, does sublobectomy require segmentectomy or wedge resection? Cho et al.~     reported that, for pulmonary ground glass opacity (GGO) nodules (Stage IA NSCLC), wedge~     resection achieved a 5-year survival rate of 98.6% in the pure GGO group and 95.5% in the~     mixed GGO group. Cho et al. cautioned against performing wedge resection for mixed GGO~     nodules with GGO component ≤ 75%, due to the high recurrence rate. When radiology shows that~     the GGO component is ≥75%, pathology usually finds that the lesions are non-invasive.~     Therefore, these lesions are potential candidates for wedge resection. This randomized~     clinical trial is to assess whether wedge resection can be established as a standard~     treatment for Stage IA NSCLC with tumor size ≤ 2 cm and GGO component ≥ 75%.~   "
64832|NCT02718352|"~     Many buprenorphine treatment programs do not have services dedicated to adolescents and young~     adults. As a precursor to developing and evaluating an adolescent and young adult~     buprenorphine treatment program at APT Foundation Inc, we propose to conduct a 1 year~     prospective study of 16 to 25 year old treatment-seeking individuals enrolled in the APT~     Adolescent and Young Adult Suboxone Program~   "
64833|NCT02718339|"~     Prospective randomized clinical trial to assess the effect of in-hospital intensive~     counseling and follow-up vs. usual care, on re-admission rates of patients with Asthma.~      The study population will include asthma patients admitted to internal Medicine departments~     and medical ICU at Soroka University Medical Center, due to asthma exacerbation.~   "
64834|NCT02718326|"~     The primary objective of the study is to assess the efficacy of intravitreal (IVT)~     aflibercept compared to sham treatment in the improvement of moderately severe to severe~     nonproliferative diabetic retinopathy (NPDR).~   "
64835|NCT02718313|"~     The purpose of this study is to investigate the type of the cardiac disease using~     transthoracic echocardiography in patients whose preoperative electrocardiography shows the~     intraventricular conduction delay.~   "
64836|NCT02718300|"~     The purpose of this study is to evaluate the safety, tolerability, and efficacy of the~     combination of INCB050465 and ruxolitinib in subjects with myelofibrosis.~   "
64837|NCT02718287|"~     This is a cluster-randomized study of a home visiting program targeting mothers of children 0~     to 2.5 years of age with the objective of improving global child development. The program,~     Programa Cresça com Seu Filho (PCCSF), will be randomized across 220 microareas in the~     poorest Region (V) of the state of Fortaleza, Brazil.~   "
64838|NCT02718274|"~     The aim of this project is to investigate the feasibility, affordability as well as the~     health and social impact of introducing HIV self-testing to rural communities through~     existing community-based volunteer services.~   "
64839|NCT02718261|"~     Data show that episodes of bleeding may often be observed in critically ill patients with~     dialysis-dependent acute renal failure (ARF) on renal replacement therapy (RRT). From a~     clinical perspective, patients with dialysis-dependent ARF and end-stage renal disease (ESRD)~     may be considered a high risk population in regard to e.g. development of gastrointestinal~     (GI-) bleeding.~      In the current prospective subanalysis SIREN of the randomized placebo-controlled clinical~     trial SUP-ICU (NCT02467621), the investigators seek to elucidate whether the subpopulation~     of critically ill patients with acute kidney injury requiring renal replacement therapy (RRT)~     benefit from prophylactic treatment with a proton-pump-inhibitor such as pantoprazole.~   "
64840|NCT02718248|"~     To refine a novel intervention using a combination of a smart phone application with best~     practice psychotherapy for men who have presented to hospital with intentional self-harm. The~     outcome will be change in baseline of scores on a depression rating scale the PHQ-9 at six~     weeks. Moreover, the investigators will ask clinicians and participants about the~     acceptability of the intervention and the acceptability of using routine data sources as~     outcome measures. This will inform methods of recruitment for the larger cluster randomized~     controlled trial and the creation of a treatment manual.~   "
64866|NCT02717910|"~     This feasibility study evaluates acceptability and preliminary effectiveness of a digital~     health game as an intervention supporting tobacco-related health literacy in 10- to~     13-year-old early adolescents. One third of the study participants will receive the health~     game, on third a web page with similar content and one third will act as a control group~     without intervention.~   "
64867|NCT02717897|"~     The purpose of this study is to test blood and tissue samples of people with Ulcerative~     Colitis (UC) to see what effects vitamin D may have on the immune system. This research is~     being done because it could lead to the development of new treatment for people with~     inflammatory Bowel Disease (IBD).~   "
64841|NCT02718235|"~     With this prospective, multicenter trial the investigators aim to establish the~     Hepatocellular Immune Score (HCCIS), a score that has been developed in a retrospective~     study, as a new tool for risk stratification of patients after resection of hepatocellular~     carcinoma that can be widely used in the clinical practice. The investigators expect to show~     that this score is a prognosticator for overall survival and also disease free survival.~     Further, it should be demonstrated that the HCCIS is a risk stratification tool that is~     independent from clinical or descriptive parameters. Additionally, the investigators plan to~     elucidate that the respective HCCIS risk groups are not only different with respect to~     immunological infiltration but are also different with respect to tumor biology. The finding,~     that tumors of the respective risk groups show different tumor biology leads to the~     assumption that different therapy strategies need to be applied. Therefore, in a~     translational approach we aim to build up a data base with HCC tumor organoids and test the~     effect of CD8+IL-33+ effector-memory cells on HCC tumor organoids of the respective HCCIS~     risk groups.~   "
64842|NCT02718222|"~     Studying the impact and performance of institutionalizing immediate post-partum IUD services~     as a routine part of antenatal counselling and delivery room services in Sri Lanka, Tanzania,~     and Nepal.~   "
64843|NCT02718209|"~     The purpose of this study is to examine the efficacy of mid-infrared spectroscopy together~     with Attenuated Total Reflection (ATR), for the detection of gynecological malignancies in~     real time during surgery.~   "
64844|NCT02718196|"~     The specific aims of this study are : 1) To pilot test the alpha build prototype of the sleep~     training smartphone application using a sample of parents looking for sleep training advice~     online. 1a) To assess the efficacy of the application in helping parents with the sleep~     training process 1b) To assess the 'workability' of the application 2) Use feedback to guide~     the next round of development with the goal of building out the applications functionality~     and increasing usability.~   "
64845|NCT02718183|"~     OBJECTIVES: The aim of this clinical randomized, double-blind clinical study was to assess~     the markers levels of RANKL IL-1B and OPGL, involved in the external cervical resorption as a~     primary outcome, and change color effectiveness in patients undergoing intracoronary~     bleaching.~      METHOD: 46 volunteers (50 teeth) participated with discoloration on non-vital teeth, with the~     endodontic treatment in good condition. Patients were randomly located into two study groups~     according to product G1 = 35% hydrogen peroxide (n = 25) and G2 = 37% carbamide peroxide (n =~     25).~      The intracameral bleaching was performed with a walking bleaching technique of 4 sessions~     Gingivocrevicular transudate samples were taken to determine levels of Il1b, RANKL, and OPGL~     with absorbent paper (Periopaper®), they are obtained from six sites per tooth bleaching: 3~     vestibular and three palatine (mesial, middle and distal), in 6 opportunities:~      Baseline, after 4-sessions of intracameral bleaching and a one week after treatment. Total~     proteins are quantified by Bradford ® system and from the eluted sample of RANKL, IL 1b and~     OPGL levels measured by ELISA (Quantikine®; R&D Systems Inc.).~      The color was evaluated in each session with Vita EasyShade spectrophotometer is used with~     the CIEL*a*b system to measure the total variation in color (ΔE), between the baseline and~     the different evaluation times.~   "
64846|NCT02718170|"~     Randomized controlled trial comparing a technique for buried intramedullary k-wire fixation~     to plate and screw fixation for unstable extra-articular metacarpal fractures.~   "
64847|NCT02718157|"~     The primary purpose of this clinical investigation is to verify the performance of the~     GenePOC GBS Assay on the GenePOC Instrument. This will be achieved by comparing the Assay to~     the a Culture, a conventional method for detection of Streptococcus agalactiae in~     vaginal/rectal swab specimens from antepartum women.~   "
64848|NCT02718144|"~     This is a multi-center, open-label, phase I/IIa trial, dose-escalation study with a 3 + 3~     cohort design to determine the recommended dose of estetrol for the treatment of patients~     with advanced breast cancer. After completing phase I part of the study (i.e. 4 weeks of~     treatment), patients will receive further treatment for 8 weeks at their individual phase I~     dose level (phase IIa part of the study).~   "
64849|NCT02718131|"~     The current study proposes adding BMP-2 (INFUSE), an anabolic agent, at the surgical site of~     TPA repair in children with NF1, compared to a control group of patients treated surgically~     without BMP-2. The following Specific Aims will be addressed: 1) to determine if use of an~     osteogenic agent (BMP-2) at the time of surgical repair of TPA in NF1 patients will result in~     improved bone healing; 2) to document safety of BMP-2 in a pediatric NF1 population; and 3)~     to collect, process, and preserve biologic specimens at the time of surgery for future~     studies.~   "
64850|NCT02718118|"~     This study is designed to evaluate the safety, efficacy, and subject and investigator~     satisfaction of 2 different injection volumes of Dysport in the glabellar lines.~        1. To determine the proportion of composite responders (based on blinded evaluator and~          subject assessments) who achieve at least a 1-point reduction from baseline in glabellar~          line severity score (GLSS) at maximum frown line on Day 30.~        2. To assess the GLSS, at maximum frown and at rest, by live assessment at all visits.~        3. To evaluate the onset of effect on appearance of glabellar lines starting at the Day 2~          visit (subject and blinded evaluator).~        4. To assess the subject's satisfaction with the treatment.~        5. To evaluate investigator satisfaction of treatment outcome.~        6. To evaluate subject psychological well-being.~        7. To evaluate subject age appraisal.~        8. To evaluate all adverse events during the course of the study.~   "
64851|NCT02718105|"~     Has the maternal KIR haplotype an impact in pregnancy, miscarriage and live birth rates per~     embryo transfer in donor oocytes -ART by paternal and oocyte donor HLA-C?~   "
64852|NCT02718092|"~     This is a multi-center, single-blinded, randomized trial comparing AXIOS FCSEMS (Fully~     Covered Self Expanding Metal Stent) and plastic stents for EUS (Endoscopic Ultrasound)-guided~     management of infected and/or symptomatic WON (Walled Off Necrosis).~      Patients will be randomized to either FCSEMS or plastic stents for EUS-guided drainage of WON~     in a 1:1 manner. Following EUS-guided drainage patients in both groups will be assessed pre-~     procedure, pre -discharge, weeks 1, 6 and months 3, 6, 12 and 24 months. Information will~     also be collected from any subsequent hospital admissions related to their walled-off~     necrosis.~   "
67688|NCT02680951|"~     This study will examine the appropriate dose and side effects of dasatinib, when it is given~     with the standard of care chemotherapy for children and adolescents with Acute Myeloid~     Leukemia (AML).~   "
64854|NCT02718066|"~     A Phase 1b/2 Study to Assess the Safety and Efficacy of HBI-8000 in Combination with~     Nivolumab in Patients with Advanced Solid Tumors Including Melanoma, Renal Cell Carcinoma~     (RCC), and Non-Small Cell Lung Cancer (NSCLC).~      The primary objective of this study is:~      -To evaluate the safety and tolerability of HBI-8000 when combined with a standard dose and~     regimen of nivolumab, to determine Maximum Tolerated Dose (MTD) and/or Recommended Phase 2~     Dose (RP2D) and to evaluate frequency and severity of toxicities of this combination~     treatment~      The secondary objectives of this study include:~        -  To explore the efficacy of study treatment as measured by Objective Response Rate (ORR),~          Disease Control Rate (DCR), Clinical Benefit Rate (CBR), Duration of Response (DoR),~          Progression-Free Survival (PFS) in all subjects treated at RP2D~        -  To obtain pharmacokinetics of twice weekly HBI-8000 when administered in combination~          with nivolumab administered once every two weeks (Phase 1b all sites; Phase 2 selected~          sites)~        -  To characterize the effect of HBI-8000 on the electrocardiogram QT corrected (QTc)~          interval (Phase 1b only)~      Exploratory:~      -To investigate the kinetics and extent of histone acetylation in peripheral blood~     mononuclear cells (PBMC) at the RP2D of HBI-8000 (Phase 2 only)~      Dose Escalation (Phase 1b) will include up to 18 subjects, followed by Cohort Expansion~     (Phase 2) including up to 20 subjects per tumor indication at MTD and/or RP2D (including~     those treated in Phase 1b).~   "
64855|NCT02718053|"~     The purpose of the study is to evaluate the reliability of spasticity measurement with~     Lokomat~   "
64856|NCT02718040|"~     This study is designed to~        1. evaluate the naturalness of facial expressions in motion (2D video images), by treating~          investigator assessment~        2. evaluate naturalness of facial expressions (photographs), by treating investigator~          assessment~        3. evaluate perceived attractiveness and age of subject (2D videos), by treating~          investigator assessment~        4. evaluate aesthetic improvement, by subject and treating investigator assessments~        5. evaluate subject satisfaction~        6. evaluate nasolabial fold (NLF) severity, by treating investigator assessment~        7. evaluate marionette lines (MLs) severity, by treating investigator assessment~        8. evaluate dynamic facial strain in animation using 3D digital photogrammetric analysis~        9. evaluate all adverse events reported during the study.~   "
64857|NCT02718027|"~     Development of a new MS-based biomarker for the early and sensitive diagnosis of Alport~     disease from plasma.~   "
64858|NCT02718014|"~     The present study was evaluated periodontal status in pre and post-menopausal women with~     periodontitis following non-surgical therapy.~   "
64859|NCT02718001|"~     Early feasibility study to evaluate the safety and function of the Edwards Lifesciences~     CardiAQ-Edwards™ Transcatheter Mitral Valve~   "
64860|NCT02717988|"~     This double-blind, placebo-controlled, single ascending dose study is designed to demonstrate~     safety, tolerability and pharmacokinetics of SKI-O-703 in healthy volunteers. The results of~     this study will guide selection of dose levels for future multiple dose studies in healthy~     volunteers and adult patients with moderately to severely active rheumatoid arthritis.~   "
64861|NCT02717975|"~     It is estimated that over 10% of men above the age of 60 will experience an episode of~     urinary retention over a period of 5 years and will need urethral catheter. Some of these~     patients are discharged from the hospital with urethral catheter, for them to attend a Trial~     Without Catheter (TWOC) clinic at a later date for catheter removal. Traditionally after~     catheter is removed in the clinic the nurse has to wait for up to 5 hours before the patient~     get the urge to pass urine and empty the bladder.~      The main objective of this study is to see the effect of catheter valve on the length of~     clinic stay (timing of discharge)for the patients (men age 60-85) after catheter is removed.~      In this study after randomization, patients in Group A (catheter valve group) will be given a~     catheter valve before they are sent home with the catheter.They will be asked to close the~     valve 3-4 hours (time required for adequate filling of bladder, which means minimum of 250~     mls in bladder with natural filling) before their appointment. It is very likely that by the~     time these patients are seen in the TWOC clinic their bladder is already full and they will~     void soon after removal of catheter.The patients in Group B (control) will go home with free~     drainage catheter and urine bag (standard catheter removal). These patients on arrival, in~     the TWOC clinic will have an empty bladder when their catheter is removed, they will then~     drink plenty of fluids in the clinic and wait for their bladder to be full before they void~     spontaneously.~      This study will last for one year after approval by ethical committee.~      The time saved in this process would lessen patient anxiety, lead to more patients being~     reviewed in clinic and therefore reduced waiting times in TWOC clinics and will save money.~   "
64862|NCT02717962|"~     The purpose of this phase 2, single arm, biomarker-driven study is to determine if treatment~     of O-6-methylguanine-DNA methyltransferase (MGMT) unmethylated recurrent glioblastoma with~     VAL-083 improves overall survival (OS), compared to historical control.~   "
64863|NCT02717949|"~     There still remains the question if hepatitis C eradication with all oral therapy will lead~     to a regression or cure of the low grade lymphoma. Thus, the hypothesis of this study is that~     oral HCV therapy will lead to a high rate of hepatitis C eradication which will correlate~     with a reduction of the size and extent of low-grade lymphoma. The hypothesis of this study~     is that subjects with hepatitis C,regardless of genotype, who have low grade lymphoma, when~     treated for hepatitis C without pegylated interferon will have a regression of low grade~     non-Hodgkin's lymphoma. In this pilot study we will evaluate the effect of~     Sofosbuvir/ledipasvir or sofosbuvir/ribavirin based antiviral therapy on the course of a~     subset of HCV-related low grade B cell non-Hodgkin's lymphoma~      Primary Objective This study will assess the safety, as measured by adverse events, in~     subjects receiving hepatitis C treatment.~      Secondary Objective The secondary objective of this study is to assess the rate of overall~     response of B cell non-Hodgkin's lymphoma defined as either as partial response or complete~     response according to revised international working group criteria for non-Hodgkin lymphoma.~      Primary Endpoint Safety and tolerability of sofosbuvir/ledipasvir or sofosbuvir/ribavirin in~     subjects with B-cell non-Hodgkin's lymphoma will be assessed by number of adverse events and~     serious adverse events. In addition, the study will assess the number of subjects who had to~     stop treatment due to adverse events or serious adverse events. The study will also examine~     the number of subjects in which treatment for lymphoma had to be given due to clinical~     progression.~      Secondary Endpoints The secondary endpoint(s) of this study is to (1) Assess the rate of~     overall response of B-cell Non-Hodgkin's lymphoma defined as either as partial response or~     complete response according to revised international working group criteria for non-Hodgkin~     lymphoma. (2) Determine the rate of sustained viral response in subjects with low-grade~     lymphoma.~   "
64864|NCT02717936|"~     Aim of the study is to verify wether it is possible to have a more sensitive diagnostic tool~     using pancytokeratin immunohistochemistry for desmoplastic squamous cell carcinoma compared~     to regular H&E staining. The investigators therefore plan to include 73 participants with a~     confirmed diagnosis of desmoplastic squamous cell carcinoma and do regular follow up.~   "
64865|NCT02717923|"~     This is a single arm, open-label, multi-center clinical trial to evaluate the efficacy and~     safety of maintenance treatment with capecitabine plus cetuximab after first-line~     5-fluorouracil-based chemotherapy plus cetuximab for patients with RAS wild-type metastatic~     colorectal cancer.~   "
64868|NCT02717884|"~     The objective of the phase I part of the trial is the determination of the maximum tolerated~     dose (MTD) of TCP (Tranylcypromine) in combination with fixed-dose ATRA (all-trans-retinoic~     acid) and with fixed-dose AraC (Cytarabine) and to derive the recommended phase II dose~     (RP2D) in patients with non-APL AML or MDS for whom no standard treatment is available or who~     failed azanucleoside treatment.~      The objective of the phase II part of the trial is a first evaluation of the efficacy of TCP~     at the RP2D in combination with fixed-dose ATRA and with fixed-dose AraC as basis for further~     investigations of TCP~   "
64869|NCT02717871|"~     To assess the safety and efficacy of PACK-CXL (photoactivated chromophore for infectious~     keratitis cross-linking) as a firstline treatment for infectious corneal infiltrates and~     early corneal ulcers, and compare it to the current standard of care, antimicrobial therapy.~   "
64870|NCT02717858|"~     This trial is conducted in Europe. The aim of this trial is to investigate the effects of~     liraglutide on gallbladder emptying in overweight and obese subjects.~   "
64871|NCT02717845|"~     Malalignment of the knee joint causes arthritis in later life. Currently there are three~     surgical ways to treat knee arthritis: total knee replacement, partial knee replacement, and~     high tibial osteotomy (HTO). The former two very much focus on treating the effect of~     malalignment, i.e. removing the arthritic joint. However, HTO addresses the cause of the~     arthritis, namely the joint malalignment. This preserves the patient's joint and it means~     that a patient will start using the unaffected part of the knee joint more.~      HTO involves cutting a wedge out the tibia to correct the alignment of that bone with the~     knee joint, to redistribute load from the affected medial part to lateral part. To keep the~     tibia in the new position, a medical nail device is attached to keep it in place and allow~     new bone to regenerate within the wedge. Currently, the market leader for HTO is the TomoFix~     (by DePuySynthes company) plate and nail device. As the name suggests, TomoFix is fixed at~     surgery and therefore the change in bone angle cannot be changed afterwards. It does mean~     that patients can be weight-bearing on the affected leg soon after the HTO procedure. A new~     CE-marked device is being tested in an interventional trial; it is produced by Ellipse~     Technologies. This device is an extendable nail and inserted intramedullary; following~     surgery the nail is tend slowly extended over a period of time until the bone correction is~     satisfactory.~      The CISKO imaging study will assess whether there is a difference between the TomoFix and~     Ellipse system in terms of bone regeneration in the tibial wedge by performing a CT-scan at 3~     and 6 months post-operatively. This will be quantified by two independent radiological~     reports. A secondary objective is to investigate patient satisfaction and also patient pain~     levels at these time intervals. The degree of bone healing is usually the main factor holding~     clinicians back when it comes to advising patients on what activities they can return to~     post-operatively. A difference in bone healing between the two systems may impact on the~     advice clinicians can give patients regarding recommencing more intense activities such as~     recreational sports, which ultimately could positively impact patients' health and~     well-being.~   "
64872|NCT02717832|"~     The overall goal of this project is to identify factors that protect some obese adults from~     becoming insulin resistant. Identifying mechanisms that help protect some obese adults from~     developing insulin resistance could lead to novel, targeted therapeutic and/or preventative~     strategies for obese adults who are insulin resistant.~   "
64873|NCT02717819|"~     The purpose of the study is to investigate if an increased protein intake, in the form of a~     protein-enriched, milk-based supplement, can enhance the beneficial effect of resistance~     training, offered during hospitalization and 12 weeks post discharge, in older patients. This~     will in part be evaluated from measures of muscle strength, muscle mass and physical~     functioning. Also, the study population's acceptance of the intervention product will be~     assessed along with measures related to 'cost-effectiveness'.~      A sub-study will be performed in a sub-group (n=30) to investigate if bio-impedance analysis~     (BIA) correlates with Dual-Energy X-ray absorptiometry (DXA) at single time points, and to~     see if it is possible to track changes in lean body mass. In addition, the reliability of the~     bio-impedance analyzer will be evaluated.~      Also, the prevalence and classification of sarcopenia will be assessed at baseline, and~     correlations to nutritional status will be investigated (n=120).~   "
64874|NCT02717806|"~     The PATHway system is designed to help patients remain physically active and maintain a good~     cardiovascular health. It proposes a novel approach that aims to empower patients to~     self-manage their CVD, set within a collaborative care context with health professionals.~     This will be achieved via a patient-centric holistic approach that specifically addresses the~     above barriers. It involves an internet-enabled and sensor-based home exercise platform. It~     is represented by several modules with an exercise module as the core component which will~     provide individualized rehabilitation programs that use regular, socially inclusive exercise~     sessions as the basis upon which to provide a personalized, comprehensive lifestyle~     intervention program (managing exercise, smoking, diet, stress, alcohol use etc.) to enable~     patients to both better understand and deal with their own condition and to lead a healthier~     lifestyle in general.~      The goal of this trial is to assess the acceptability, short-term effectiveness on lifestyle~     and health related physical fitness and cost-effectiveness of the PATHway intervention in~     patients with CVD in a single blind multicentre pilot randomised controlled trial (RCT).~   "
64875|NCT02717793|"~     1 repetition maximum (RM) and Maximum Voluntary Contraction (MVC) with digital dynamometer~     are popular method of measuring muscle strength. The types of muscle contraction involved in~     both are different, 1RM involves isotonic muscle contraction (ITMC) and MVC with digital~     dynamometer involves isometric muscle contraction (IMMC). There are several risks involved in~     measurement of 1RM, such as delayed onset muscle soreness (DOMS) and unsafe for pathological~     joints etc, this can be reduced if IMMC is used in measuring strength. Though both cannot be~     equated as they are different type of contraction, therefore the purpose of this study was to~     compare between 1RM measurement and isometric MVC using a digital hand-held dynamometer in~     healthy females. Twenty nine young females (mean age = 20.77 ± 1.28) without any weight~     training experience (mean BMI = 20.43 ± 1.85) volunteered for the study. It was a crossover~     trial where 48 hours of rest period was given between each measurement technique. The result~     showed moderate correlations (r = 0.365-0.847) between 1RM and MVC. A simple linear~     regression analysis revealed a significant estimated regression equation for dominant and~     non-dominant hands. [Dominant, Y=0.391x + 1.472; Non-Dominant, Y=0.251x + 2.629; (Y: 1RM, x:~     Isometric)] with low standard error of estimation value of (Dominant, 0.74; Non-dominant,~     0.80). The result also showed no significant difference between these derived equations and~     Brzycki 1RM prediction equation. Therefore, it was concluded that both prediction equations~     can be used interchangeably to predict the strength of a person, and thus IMMC can be used to~     predict 1RM in healthy females.~   "
64926|NCT02717130|"~     An Open-label, Multi-center, Longitudinal, Within-subject Comparison Study to Evaluate the~     Effects of Aripiprazole Once Monthly in Subjects with Schizophrenia on 30-, 90-, and 180- day~     Re-hospitalization Rates Following Hospital Discharge Compared with Retrospective~     Re-hospitalization Rates while on Oral Antipsychotic Medication.~   "
64876|NCT02717780|"~     The investigators aim to assess the respiratory effect of short half-life agents in balanced~     anesthesia on patients suffering from non-treated or suspected obstructive sleep apnea~     syndrome (OSA) We will study the impact on OSA of a regimen of remifentanil-desflurane versus~     a regimen of fentanyl-sevoflurane. Each patient will undergo three respiratory portable~     polygraphies: the night before the surgery ; the first night following the surgery ; the~     third night following the surgery.~   "
64877|NCT02717767|"~     The diagnosis of pneumonia is challenging in Intensive Care Unit. The auto-fluorescence of~     white corpuscles is altered during pneumonia. In presence of bacterial growth on lung~     samples, the measure of autofluorescence of white corpuscles could help the clinicians to~     discriminate bacterial colonization from acute infection.~   "
64878|NCT02717754|"~     This multi-center, randomized, double-blind, multiple-dose, placebo-controlled,~     parallel-group study will assess the safety and PK of oseltamivir (Tamiflu) and its~     carboxylate metabolite, RO0640802 in healthy participants. Participants will be randomized to~     receive 100 milligrams (mg) oseltamivir, 200 mg oseltamivir, or placebo, all administered~     intravenously twice daily (BID). The anticipated time on study treatment is 5 days.~   "
64879|NCT02717741|"~     Tafetinib is an oral multitargeted tyrosine kinase inhibitor that inhibits Vascular~     Endothelial Growth Factor Receptor (VEGFR).~      This phase I trial was conducted to evaluate the pharmacokinetics (PK), safety, and~     preliminary efficacy of tafetinib in Chinese patients with advance solid tumor. The study are~     conducting in Cancer Hospital Chinese Academy of Medical Sciences.~   "
64880|NCT02717728|"~     There is currently no standard of care or best practice for managing post-operative pain for~     patients undergoing hip arthroscopy. Perioperative pain with these procedures can be~     substantial. It has been shown that up to 90% of patients in the Post-anesthesia care unit~     (PACU) following hip arthroscopy report pain scores of 7/10. Poor pain management following~     hip fracture surgery directly results in increased time spent in high cost health care areas~     and delayed time to ambulation. Continuous regional anesthesia following hip arthroplasty has~     been shown to reduce narcotic consumption and related side-effects (reduction of~     post-operative pain, delirium, and length of stay).~      The purpose of this research is to evaluate the effectiveness of a fascia iliaca nerve block~     in reducing post-operative pain within the first 24 hours following hip arthroscopy.~     Additionally, the pharmacokinetics of the drug ropivacaine will be studied via laboratory~     analysis of blood samples. Ultimately, the objective of this research is to develop a~     standard of care or best practice for the management of post-operative pain following hip~     arthroscopy. This study will include the entire age range of patients who are seen for hip~     arthroscopy at Boston Children's Hospital, for which there is a 35 year age limit. Both sexes~     will be included in the study.~      The study design will be real catheter versus a sham catheter(control). All subjects will~     receive general anesthesia. The catheters (real or sham) will be administered after the~     induction of general anesthesia and before the beginning of the surgery until 24 hours after~     recorded PACU admittance time. The anesthesia team placing the block will not be blinded. The~     orthopaedic surgeon (Dr. Yen) and all evaluators will be blinded to the absence or presence~     of a real catheter. In the case of a sham catheter, the anesthesia team will rig a pump to~     look like it is dispensing local anesthesia.~      To determine the pharmacokinetics of ropivicaine during standard fascia iliaca block,~     following induction of general anesthesia, a large bore IV catheter will be inserted for the~     purpose of blood draws (all patients).~   "
64881|NCT02717715|"~     This study aims to determine the effect of a supervised home-based physical fitness program~     on the aerobic capacity, quality of gait and health related quality of life in people with~     chronic ischemic stroke. Secondly, feasibility of the program for implementing a long term~     lifestyle change will be investigated.~   "
64882|NCT02717702|"~     Acute Coronary Syndrome (ACS) is a serious heart condition that is a leading cause of death~     in America. Cardiac stress testing is currently the best test to non-invasively identify~     which patients might be having ACS and may need more invasive testing such as a cardiac~     catheterization (placing a tube in the heart) for coronary angiogram (invasive mapping of the~     blood vessels of the heart). However, stress tests require imaging by highly trained~     specialists and even then may not correctly categorize a small minority of patients being~     evaluated for ACS.~      Advances in blood tests may now allow detection of the very early stages of heart blood~     vessel blockage via a simple blood test. The investigators seek to determine whether these~     blood tests can help to better identify patients with ACS. The study will also store any~     extra blood sample that may be left over for future use.~   "
64883|NCT02717689|"~     This study explores if a composite biomarker strategy predicts exacerbation risk in patients~     with asthma on high dose inhaled corticosteroid (+/-long-acting beta agonist) treatment and~     to evaluate the utility of this composite score to facilitate personalised biomarker specific~     titration of corticosteroid therapy in this population.~   "
64884|NCT02717676|"~     Previous studies concluded that striae gravidarum assessment appears to predict the~     occurrence of perineal tears and recommend training the health personnel to calculate the~     total striae score which can help them decide if episiotomy is to be given or not. Episiotomy~     definitely seems to be preventive for perineal tears but giving episiotomy for the same is~     still debatable as episiotomy in itself is associated with morbidity. the hypothesis is~     episiotomy done in patients with high score will definitely protects against perineal tears.~     So, the aim of study is to determine whether assessment of striae gravidarum score could~     predict occurrence of tears during labor or not, and if episiotomy will prevent perineal~     tears in women with high score.~   "
64885|NCT02717663|"~     The purpose of this study is to develop adaptive (AI) and micro-incentive (MI) interventions~     and test them against static (SI) and delayed-incentive (DI) interventions in a 4-arm~     randomized factorial trial to increase MVPA adoption and maintenance among inactive adults.~     Using neighborhood walkability and socioeconomic status, participants will be recruited from~     four neighborhood types: high walkable/high SES, high walkable/low SES, low~     walkable/high SES, and low walkable/low SES. We will evaluate synergistic or antagonistic~     effects of interventions and neighborhood factors on MVPA adoption by 12 months and~     maintenance by 24 months.~   "
64930|NCT02717078|"~     This study will investigate the use of a low biologically available and high protein diet~     (LoBAG) for treatment of type 2 diabetes mellitus. Subjects with type 2 diabetes will be~     recruited and asked to adhere to this diet or a control diet for 12 weeks. Food preparation~     will be done by subjects at home, following instruction from the study team including a~     dietitian. The study will test the hypothesis that the LoBAG diet will lead to a greater~     reduction in hemoglobin A1c (HgbA1c) than a control diet over 12 weeks of intervention.~   "
64972|NCT02716532|"~     This study will be targeting patients suffering from acute brain injury (ABI), including~     those with severe trauma brain injury (sTBI) and those with aneurysmal sub arachnoid~     hemorrhage (aSAH).~      This clinical study is an open-label, non-randomized, single-center, exploratory metabolic~     study.~      The primary objective is to determine changes from baseline (before enteral administration of~     Peptamen AF) in plasma and brain extracellular levels of MCFAs and Ketone bodies in sTBI~     patients upon Peptamen AF nutritional support.~   "
64886|NCT02717650|"~     Exercise testing has become clinically important in the management and ongoing evaluation of~     patients with Cystic Fibrosis (CF) with higher rates of exercise tolerance and participation~     previously linked to lower mortality risk (1).~      Lower exercise capacity generally correlates with more severe lung disease (2,3) and landmark~     studies suggest that low exercise capacity as measured by peak oxygen capacity (VO2peak) and~     rate of decline in lung function (FEV1) are strong predictors of mortality (1,4). However not~     all studies have found pulmonary function tests (PFTs) to be reliable predictors of maximal~     exercise capacity (5), especially in relatively well preserved lung function (6,7).~      The wide distribution in physical capacity between fit individuals and end stage disease adds~     to complexity of assessment. Independent factors of age, genetics, habitual exercise,~     nutritional status and musculoskeletal conditions are all known to influence physical~     capacity in patients with CF (8,9).~      Maximal exercise testing places additional stress on cardiovascular, respiratory and~     peripheral systems providing more information around multiple influences on disease~     progression including degree of limitation in these major systems (10,11) and is useful for~     assessment of exercise desaturation, more common (but not always present) in advanced lung~     disease (5,12).~      With prediction of exercise performance and functional capacity from PFTs unreliable and the~     understanding that health status correlates better with exercise tolerance there has been an~     increase in maximal exercise testing for patient management (13). Many international centers~     now regard exercise testing as highly important with many assessing maximal exercise capacity~     annually to monitor disease progression, identify physical status and drive changes in~     medical, physiotherapy or nutritional management (14,15).~      The main vision is to develop a standardized incremental step test protocol suitable for~     adults with Cystic Fibrosis (CF), all ages, levels of fitness and disease state that is in~     line with current exercise testing recommendations (15). To develop a more useful field test~     to assess exercise tolerance and a more user friendly test than the currently available~     laboratory exercise test to allow for early detection of decline in physical function in the~     day-to-day clinical setting. To date no studies have been published in adults with CF where~     an incremental exercise step test has been investigated to assess exercise tolerance or~     determine maximum oxygen uptake (VO2max).~   "
64887|NCT02717637|"~     All patients undergoing an elective caesarean section under spinal anesthesia will, according~     to the hospital routines, receive 10 mg oxycodone slow-release tablet when arriving at our~     postoperative care unit (PACU). Blood samples will be taken at 0 hour, 1 hour, 2 and 6 hours~     after administration in order to investigate bioavailability.~   "
64888|NCT02717624|"~     To characterize the safety profile of acalabrutinib in combination with bendamustine and~     rituximab in subjects with treatment naive and relapse/refractory Mantle Cell Lymphoma (MCL)~   "
64889|NCT02717611|"~     A Phase 2 Study to evaluate the Efficacy and Safety of ACP-196 (acalabrutinib) in Subjects~     with Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy~   "
64890|NCT02717598|"~     Background:The optimal technique for removal of diminutive or small colorectal polyps is~     debatable.~      Objective:To compare the complete resection rates of cold snare polypectomy (CSP) and hot~     snare polypectomy (HSP) for the removal of adenomatous polyps(3-9mm).~      Design：Prospective randomized controlled study. Setting：Three tertiary referral hospitals.~     Patients：we will recruit a total of 330 polyps(3-9mm). Interventions:Enrolled patients were~     randomly assigned to one of the two polypectomy protocols (CSP vs. HSP) using a~     computer-generated random sequence. If a patient had one or more polyps, all eligible polyps~     were removed using the initially assigned polypectomy protocol. After the initial~     polypectomy, additional EMR was performed at the polypectomy site to assess the presence of~     residual polyp tissue.~      Main Outcome Measurements:The primary study outcome was to compare the complete polyp~     resection rate between groups. Secondary outcomes included rate of postpolypectomy adverse~     events, including bleeding, perforations,infection and rate of tissue retrieval(Complete~     resection was defined as the absence of residual polyp tissue in the EMR sections of the~     polypectomy site).~   "
64891|NCT02717585|"~     Fibromyalgia (FM) is a chronic pain disorder associated with a wide spectrum of sleep~     disorders. In fact, insomnia and waking unrefreshed are currently considered part of the~     criteria for diagnosis. Recent studies show that sleep quality and symptoms of FM are~     inversely correlated. Obstructive sleep apnea (OSA) is a sleep disorder characterized by~     repeated episodes of complete or partial blockage of the upper airway. Nonrestorative sleep~     and fatigue are common symptoms of FM and OSA and may suggest related pathophysiology or~     co-morbidity that is yet to be diagnosed. This prospective randomized controlled clinical~     trial will enroll adult FM patients who screen positive for OSA by the STOP-Bang~     questionnaire. OSA will be confirmed by a laboratory polysomnography (PSG) study. After~     undergoing further baseline questionnaires and investigations, patients confirmed to have FM~     with moderate to severe OSA will be randomized to one of two different treatments: 1)~     Treatment for FM at the Chronic Pain Clinic together with Continuous Positive Airway Pressure~     (CPAP) devices for their OSA OR 2) Control group receiving treatment for FM at the Chronic~     Pain Clinic only.~   "
64892|NCT02717572|"~     In the current study, the investigators plan to expand the knowledge of Positron Emission~     Tomography/Magnetic Resonance (PET/MR) reliability by assessing the repeatability of~     fludeoxyglucose (FDG) standardized uptake values (SUV) measurements, as well as apparent~     diffusion coefficients (ADC) measurements, in a broad population of patients with malignant~     solid tumors.~   "
64893|NCT02717559|"~     In this study the investigators will examine patients who have undergone unilateral ACL~     reconstruction surgery to determine which structural and functional characteristics of the~     knee two and ten years post reconstruction surgery, aspects of the original injury and~     repair, and patient characteristics are risk factors for osteoarthritis after ACL~     reconstruction surgery.~   "
64894|NCT02717546|"~     The objective of this observational prospective study is to systematically document the~     clinical outcomes of Zimmer MotionLoc Screws for Periarticular Locking Plate System applied~     to distal tibia fracture treatment and confirm safety and performance of the screws.~   "
64895|NCT02717533|"~     The objective of the proposed study is to demonstrate that serial blood volume analysis (BVA)~     using RI-BVA (BVA-100, Daxor, NY) can be used to guide changes in prescription of dry weight~     for hemodialysis patients. The knowledge of a patient's ideal BV and degree of hypervolemia~     using these measurements can be used to change the prescription of DW in an objective way~     instead of the current standard of practice, which is based on subjective prescription of dry~     weight. A first study was conducted to determine the rate of plasma volume (PV) re-expansion~     for each patient as a guide to rate of fluid removal (results published, refer to citations).~     A second study was conducted in order to assess the value of a BVA measurement in guiding~     prescription of clinical DW. A follow up BVA would then be done in order to check if patients~     were closer to ideal BV than prior to changing dry weight.~   "
64945|NCT02716883|"~     In this study Investigators are going to do early amniotic membrane transplantation (AMT) for~     bacterial keratitis.~   "
64984|NCT02716376|"~     To investigate the incidence of tuba dysfunction (TD) and middle ear (ME) morbidity after~     radiotherapy (RT) to the Head & Neck and test the effect of auto-inflation of the Eustachian~     tube (ET) on middle ear effusion with a special designed balloon (Otovent®) and thereby~     better hearing and ear related quality of life after cancer treatment.~   "
64896|NCT02717520|"~     The primary objective of this study is to evaluate long-term clinical performance of a glass~     hybrid restorative system (glass-ionomer) vs. composite resin material over a period of five~     years. The secondary objective is to evaluate the suitability of intraoral impressions for~     the assessment of wear of teeth and restorative materials over five years. For that purpose~     the replica method and scanning 3-D laser equipment and matching software will be used.~      The first null hypothesis is that there would be no difference in clinical performance~     between restorative materials after five years. The second null hypothesis is that wear~     between the restorative materials will be the same after five years.~      This is a multicentre, controlled clinical study conducted in Croatia, Italy, Turkey and~     Serbia. Eligible participants are all adults aged 18 or over with indication of restorative~     treatment on vital teeth in posterior molar region, limited to two surface in a healthy~     subjects. Exclusion criteria are presence of full dentures or crowns and bridges in occlusal~     contact with teeth indicated for restorative treatment, severe bruxing and unstable~     physiological or medical health, pregnancy and lactation, radiation therapy or using drugs.~     Each patient is receiving two restorative treatment (GIC-EQUIA Forte and composite resin~     material Tetric EvoCeram) each of which will be localized on molar teeth on either side of~     the mouth. Two independent examiners will evaluate the restorations at each site one week~     after placement and at one, two, three, four and five years according to the FDI criteria.~     After, three and five years recall, impressions of both restorations is taken and the casts~     is analysed by a 3D laser scanner.~   "
64897|NCT02717507|"~     This randomized phase IIb trial studies how well low-dose carvedilol works in preventing~     heart failure in cancer survivors exposed to high dose anthracyclines for management of~     childhood cancer. Patients who received high-dose anthracycline chemotherapy are at a much~     greater risk for developing heart failure compared to survivors who didn't get any~     anthracycline chemotherapy. Heart failure happens when the heart muscle has been weakened and~     can't pump blood as well as it should. Carvedilol may help lower the risk of cardiovascular~     complications.~   "
64898|NCT02717494|"~     The purpose of this study is to determine the safety, reactogenicity, immunogenicity,~     transplacental antibody transfer and interference with infant responses to childhood~     vaccination of maternal vaccination with pneumococcal conjugate 10-valent vaccine (PCV-10) or~     pneumococcal polysaccharide 23-valent vaccine (PPV-23) by comparison with placebo.~   "
64899|NCT02717481|"~     Examine a new method based on fusion between ultrasound (US) and previous~     ultrasound/computerized tomography(US/CT) studies to evaluate the size of abdominal aneurysm~     and measure the changes over time and following invasive repair procedure.~   "
64900|NCT02717468|"~     In high-risk patients, it is now recommended to guide the intraoperative volume replacement~     via the stroke volume.~      Today, the most commonly used technique for estimating the stroke volume is the arterial~     waveform analysis in the radial artery. This technique has the disadvantage of being invasive~     and increasing the time dedicated to anesthesia during the surgery.~      The future is the non-invasive monitoring of stroke volume. Thus, Edwards Life Science has~     developed a continuous monitoring technology and non-invasive arterial pressure, cardiac~     output and stroke volume using a digital sensor (ClearSight®). The continuous monitoring of~     blood pressure by this technique was validated in cardiothoracic surgery but studies about~     monitoring cardiac output or stroke volume are inconclusive and contradictory.~      The objective of this study is to compare the use of non-invasive monitoring of stroke volume~     by Clearsight® with the arterial waveform analysis in the radial artery by Pulsioflex® in~     major surgery.~   "
64901|NCT02717455|"~     This phase I trial studies the side effects and best dose of panobinostat in treating younger~     patients with diffuse intrinsic pontine glioma (DIPG). Panobinostat may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. Stratum 1 treats patients~     with DIPG that has returned or gotten worse (progressed). Stratum 2 treats patients with DIPG~     that has not yet gotten worse.~      Currently, only Stratum 2 is enrolling patients.~   "
64902|NCT02717442|"~     The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of~     Meniere's disease.~   "
64903|NCT02717429|"~     The investigators propose to conduct a randomized feasibility study of mindfulness meditation~     training (MMT) relative to an active cognitive training control group and waitlist control~     group in improving emotional regulation in individuals with MS. Individuals will complete~     pre- and post-assessments of emotional functioning through a week of daily diary entries, as~     well as self-report measures and a behavioral paradigm. Additionally, all participants will~     complete an evaluation of neuropsychological functioning, before and after intervention.~   "
64904|NCT02717416|"~     Acute upper gastrointestinal hemorrhage (UGIH) is a common condition that leads to hospital~     admission, and has significant associated morbidity and mortality, especially in the elderly.~     The most common causes of acute UGIH are nonvariceal. Although up 70% of non-variceal bleeds~     settle with conservative measures, endoscopic therapy is the established method for treating~     those bleeds for which this is not sufficient. Despite advances and increased expertise in~     managing upper gastrointestinal bleeding, the associated mortality of up to 15% has remained~     unchanged for several years.~      EndoClot is a novel topical hemostatic powder approved for use in non-variceal upper~     gastrointestinal bleeding. This study examines its efficacy for endoscopic hemostasis in~     non-variceal upper gastrointestinal bleeding. This is a multicenter, prospective, randomized~     study.~   "
64927|NCT02717117|"~     Crohn's disease (CD) is becoming more common. One of the main features of this disease is~     weight loss and malnutrition with symptoms such as tummy aches and bloating. These problems~     have a strong negative effect on the patients' quality of life but the causes of these~     problems are not well understood.~      Enteroendocrine cells are nutrient sensors in the bowel that secrete special chemicals~     (called hormones) that control appetite and the movements all the gut. The investigators~     think that this control mechanism goes wrong in Crohn's patients and they have set off to do~     more research on this. Looking at the inside work of the gut has always been difficult and at~     times unpleasant for patients, however recent developments in magnetic resonance imaging~     (MRI) are allowing the investigators to study the workings of the gut in greater detail and~     without discomfort for the patients.~      Before studying the Crohn's patients it is necessary to run a set of pilot experiments in~     healthy volunteers using a test meal and subsequent MRI imaging to look at the motion of the~     gut. This validation stage of the methodology is essential before embarking in more detailed~     studies in the patients.~   "
64905|NCT02717403|"~     Objectives:~      The overall goal of this study is to use the principles of chronic disease management to~     develop and test an online social networking intervention using the FB platform in a~     randomized controlled trial. Our specific objectives are as follows:~      Aim 1: To develop and establish an independent closed community in FB for patients with~     rheumatoid arthritis, providing an educational platform for disease self-management and the~     potential for engaging in social networking with peers (Phase 2).~      Objective 1. To beta test the features and navigation buttons and panels in the newly~     developed website and FB group.~      Objective 2. To evaluate the contents, ease of use and satisfaction with the newly developed~     website and FB group by patient advocates (consultants to the study) who participate as~     members of the Facebook community.~      Aim 2: To evaluate the efficacy of the FB community intervention combined with an educational~     website to improve patients' self-management (including knowledge, which is the primary~     outcome), decision making and patient-reported outcomes compared with the educational website~     alone (Phase 3). We hypothesize that participation in an online closed community offering~     evidence-based information combined with peer interaction and support will improve patients'~     knowledge.~   "
64906|NCT02717390|"~     The Investigators propose to conduct a pragmatic randomized controlled trial of 350 one to~     four year old children and their caregivers to study the effectiveness of 1) the Bright By~     Three (BB3) intervention for promoting children's language and socio-emotional development~     and 2) a modified version of the Safe 'N Sound (SNS) intervention for reducing safety hazards~     and injuries. The SNS intervention will serve as a control for the BB3 group and vice versa~     so that all study participants will receive a clinically meaningful intervention. In~     collaboration with primary care clinics that serve low-income and minority children, the~     Investigators will recruit and randomize 350 twelve to fifteen month olds and their~     parents/caregivers to one of the two intervention arms and deliver the interventions over a 2~     year period.~   "
64907|NCT02717377|"~     This study is designed to test the effects of six 5 minute microbursts of physical activity~     spread across the day as compared to either a sedentary control condition or a single 30~     minute bout of moderate intensity physical activity on cognitive function, self-reported~     energy levels, aspects of eating behavior and measures of metabolic health. The primary~     hypotheses are:~        1. Hourly 5 minute bouts of moderate intensity exercise during the day will increase~          afternoon cognitive function as compared to a no exercise condition.~        2. Hourly 5 minute bouts of moderate intensity exercise during the day will increase~          afternoon cognitive function more than a single 30 minute AM bout.~      Secondary exploratory hypotheses include~        1. Hourly 5 minute bouts of moderate intensity exercise during the day will increase~          self-reported energy levels, reduce orexigenic appetitive measures and improve measures~          of metabolic health as compared to a no exercise condition.~        2. Hourly 5 minute bouts of moderate intensity exercise during the day will increase~          self-reported energy levels, reduce orexigenic appetitive measures and improve measures~          of metabolic health more than a single 30 minute AM bout.~   "
64908|NCT02717364|"~     This study is a local, prospective, non-interventional, non-controlled, multicenter,~     observational study (regulatory postmarketing surveillance). Each physician will enroll~     patients who have received at least 1 dose of Yervoy, and each patient will be followed for~     up to 12 months. All patients will be evaluated for safety and effectiveness during Yervoy~     use (4 doses) and for 12 months from the first dose of Yervoy to confirm the safety profile~     of Yervoy under routine, daily practice~   "
64909|NCT02717351|"~     To evaluate the Sun Protection Factor efficacy on human skin.~   "
64910|NCT02717338|"~     The purpose of this study is to determine whether enhancing blood donor competence, autonomy,~     and/or relatedness increases intrinsic motivation to donate and improves donor retention.~   "
64911|NCT02717325|"~     To evaluate the Sun Protection Factor (SPF) efficacy on human skin.~   "
64912|NCT02717312|"~     The rates of cesarean section (CS) are rising all over the world. Worldwide the number of CS~     is millions every year. CS is one of the most frequently performed operation for women. As a~     consequence many women have a scar in their uterus. Cesarean scar may be associated with~     complications in later pregnancies. In recent years there have also been a few reports~     indicating that cesarean scar could potentially be associated with menstrual disorders and~     infertility. The impact of cesarean scar defect on long term welfare or quality of life is~     not clear.~      In some women with a history of CS it is possible to recognise a defect in the site of~     previous uterotomy years after the performed CS by sonographic examination. This defect in~     the scar, also called as a niche, is a consequence of incomplete healing of the scar in the~     lower part of uterus. To date there is uncertainty relating to the factors that lead to poor~     healing of cesarean scar. Also impact of cesarean scar defect on later well-being and later~     pregnancies are not properly known.~      The purpose of this study is to investigate the prevalence and the risk factors of cesarean~     scar defect. Also the impact of cesarean scar defect on women´s menstrual health, fertility,~     further deliveries and quality of life will be investigated.~      This study is a prospective observational cohort study. Women at the age of 18-45 years who~     will give birth by elective or emergency CS will be asked to participate. Women are recruited~     within two days of CS. Women with known uterus anomaly or von Willebrand disease will be~     excluded.~      The prevalence of scar defect will be evaluated by transvaginal sonography and~     contrast-enhanced sonohysterography using saline infusion. Both 2-dimensional and~     3-dimensional sonography will be used. Sonographic evaluation will take place 6 months after~     the CS.~      The following definition for CS scar defect will be used: myometrial discontinuity with a~     depth of ≥2 mm at the site of cesarean scar that communicates with the uterine or cervical~     cavity as seen on transvaginal sonography with or without saline infusion.~      The prevalence of menstrual disorders will be evaluated 12 months after the CS. The subjects~     will be asked to report the number of menstrual bleeding days once a month during 3~     consecutive months. Postmenstrual spotting is defined as ≥2 days of brownish discharge at the~     end of menstruation with total bleeding days of ≥7 or non-cyclic bleeding not related to~     menstruation.~   "
64913|NCT02717299|"~     The purpose of this study is to compare the patient reported outcome measures of total knee~     replacement patients who received intra operative sensor guided technique for soft tissue~     balancing to a group of patients who receive surgeon guided soft tissue balancing.~   "
64914|NCT02717286|"~     The restorative management of molars with Molar-Incisor Hypomineralization (MIH) represents a~     challenge in the clinical practice with high failure rate. Thus, this clinical trial aimed to~     evaluate the clinical survival of direct composite resin restorations in first permanent~     molars (FPMs) that are affected by MIH, comparing two adhesive systems.~   "
64915|NCT02717273|"~     This study will be to prospectively determine differences in Surgical Site Infection (SSI) if~     a prolonged course of post-operative antibiotics are used following liver transplantation.~   "
64928|NCT02717104|"~     The purpose of the registry is to assess the clinical use and safety of the LUTONIX Drug~     Coated Balloon Catheter in a heterogeneous patient population in real world clinical~     practice.~   "
64929|NCT02717091|"~     The aim of this study is to clarify the efficacy and safety of neoadjuvant FOLFIRINOX and~     nab-paclitaxel + gemcitabine for borderline resectable pancreatic cancer.~   "
64916|NCT02717260|"~     Inhibition control deficits is a major risk factor in the transition to the act in suicidal~     patients. Neuroimaging studies have shown that this failure was associated with hypoactivity~     in the prefrontal cortex (PFC), a brain area involved in the control of impulsivity. It was~     recently shown that a noninvasive brain stimulation session applied on the PFC reduces~     transiently impulsivity in healthy volunteers. Noninvasive brain stimulation modulates the~     activity and connectivity of neural network connected to the stimulation site. The~     investigators assume that a repetition of noninvasive brain stimulation sessions on the PFC~     will allow a more intense and longer lasting effect on impulsivity and cognitive control in~     healthy volunteers compared to a single session and to placebo stimulation. The investigators~     assume that this behavioral change will be accompanied by a change in brain activity measured~     by resting EEG for the patients in the active group. A more intense and longer lasting effect~     is an essential step to transfer these results to patient populations.~      The main objective is to study the effect of bilateral stimulation of the PFC by transcranial~     random noise stimulation (tRNS) on the inhibition control measured by the cognitive motor~     inhibition capacity (Go NoGo test). The secondary objectives are to study the effect of tRNS~     on verbal inhibition (measured with the Hayling test); on anxiety (measured with the~     State-trait anxiety inventory (STAI)),on angry (measured with the State-trait anger~     expression inventory (STAXI)) on verbal and nonverbal inhibition (measured by the Stroop~     test), on impulsive behavior (measured by the Barrat impulsiveness scale (BIS 10)) and on the~     neuronal electrical activity measured by EEG.~   "
64917|NCT02717247|"~     Obesity is worldwide a public health problem. According to World Health Organization (WHO),~     overweight and obesity are the fifth death risk factor worldwide. At least 2.8 million adults~     die each year. Food addiction is one of the causes of obesity that may benefit from new~     therapeutic options.~   "
64918|NCT02717234|"~     To assess the effect of consumption of an oral nutrition supplement on Arginine, a blood~     marker of nutritional intake~   "
64919|NCT02717221|"~     The investigators developed 18F-MPG as a targeted molecular imaging agent for noninvasive and~     repeatable detecting EGFR-activating mutational status.~   "
64920|NCT02717208|"~     To evaluate the safety, local tolerability and pharmacokinetic characteristics after~     administration of eye-drop HL036 in healthy Korean male volunteers~   "
64921|NCT02717195|"~     To evaluate the efficacy of 10 and 20 mg/day of Lu AF35700 on schizophrenia symptoms in~     patients with treatment-resistant schizophrenia (TRS)~   "
64922|NCT02717182|"~     Interest in patient therapeutic education (PTE) is increasing: in France PTE was included~     within the 2009 Hospital, Patient, Health and Territory law as an essential component of~     the patient healthcare pathway.~      PTE is a complex intervention: its delivery is variable and may vary according to its~     content, functioning, providers, targeted patients, environment and even its objectives.~     These differences impact the expected results and make difficult the evaluation of PTE~     interventions. To overcome this difficulty, it is essential to describe precisely the~     intervention, the processes and the implementation of PTE that are usually not known. PTE~     interventions need today a global understanding of their mechanisms constituting their~     complexity.~      CONCErTo study aims at developing a classification of the different elements composing a PTE~     intervention that can impact their results and can ensure their continued existence.~      Mechanisms implemented during PTE interventions will be analyzed by a qualitative research.~     The investigators wish to identify organizational, pedagogical, psychosocial, medical or~     contextual elements that can impact the results, the patients' participation and the~     continuity of the program.~      The perspective of this research is to improve the understanding of PTE by providing thorough~     description of the interventions. This work will help stakeholders to better interpret the~     results of their interventions, to improve the transferability, the implementation and~     finally to determine which are the elements able to improve patients' health status.~   "
64923|NCT02717169|"~     Background: The interactions between human beings and wearable technology like activity~     trackers equipped with biometric sensors can be linked to health related new learning~     concepts/instructional methods supporting deep knowledge acquisition, situated,~     self-regulated and active learning. This personalized, long term interactions where specific~     information is pushed to the learner contributes to deepen the personal understanding related~     to the concept of and knowledge about health and has an impact on long term health action~     process.~      Design and methods: In order to understand the behavioural change process, a multiple case~     study including 35 higher education students in Hong Kong from an undergraduate course, BSc~     Exercise and Health is currently conducted. Each student uses a wearable device (activity~     tracker) over a period of five months, reflects weekly on emerging personal data, documents~     their thinking and action in the ePortfolio, and engages in an online forum. The participants~     enter their experiences with the biometric data, lifestyle adaptations (e.g. more steps),~     special situations (e.g. hike, heart rate changes during activity) and how these experiences~     lead to specific searches and actions on the web and/or in their real social network. The~     ePortfolio will allow the students to critically reflect on their progress and for the~     researchers to intervene at any time on the issues related to the participants' postings.~     EHealth literacy is used as indicator for the health action process of the participants.~     Evidence regarding change in eHealth at the beginning and end of the intervention will be~     collected with a standard questionnaire detecting eHealth their literacy scale.~      Scope: By reflecting on the information from their personal activity tracker and documenting~     it in their own ePortfolio, the students will continuously learn to analyse, search and~     critically assess health related personal and available digital information, organize it,~     present and discuss it with peers/tutor. This in turn will enhance critical thinking, raise~     questions about health related topics, stimulate further inquiry deepen their knowledge about~     personal health, inducing a healthier lifestyle.~   "
64924|NCT02717156|"~     This phase II trial studies how well recombinant EphB4-HSA fusion protein and pembrolizumab~     work in treating patients with urothelial (bladder) cancer that has spread from the primary~     site to other places in the body or has come back and does not respond to certain~     chemotherapy drugs. Combinations of biological substances in recombinant EphB4-HSA fusion~     protein may be able to carry tumor-killing substances directly to urothelial cancer cells.~     Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of cancer cells~     to grow and spread. Giving recombinant EphB4-HSA fusion protein and pembrolizumab together~     may be a better treatment for patients with urothelial cancer.~   "
64925|NCT02717143|"~     Acute myocarditis is a serious illness affecting a young population with a very variable~     course (of full recovery at the onset of dilated cardiomyopathy (DCM), or even sudden death).~     Very few studies have examined the predictors of death and serious cardiovascular events in~     acute myocarditis and have carried on numbers of restricted patients. What little data~     results in a lack of a precise recommendation on the management and the follow-up period of~     patients.~      This observational study should identify serious prognostic factor for cardiovascular events~     in order to provide a support strategy and more appropriate monitoring of myocarditis.~   "
64931|NCT02717065|"~     Characterizing the nature and severity of tinnitus in individuals presents a particular~     challenge. The nature of the sound (loudness and pitch) is not necessarily indicative of the~     effect on quality of life. Different methods are used to measure each parameter. Loudness is~     measured using a technique called minimum masking, in which the subject is presented with a~     broadband white noise and asked to adjust the loudness level until they can no longer hear~     their tinnitus. Severity of tinnitus is commonly characterized using two questionnaires: the~     Tinnitus Handicap Inventory (THI) and the Tinnitus Functional Index (TFI). These~     questionnaires assess the perceived severity of the tinnitus and the effect on everyday~     activities and quality of life. A visual analog scale (a scale from 0-10) is used as a~     general subjective measurement of tinnitus severity. In the first part of this study, we will~     measure each of these parameters over a series of sessions to establish a baseline~     variability for each individual.~      The second part will look at the influence of context-specific visual information on auditory~     perception. This involves watching silent videos of a person speaking, with and without an~     additional tone designed to match the subject's tinnitus. The effect of this audiovisual~     feedback on the subject's perception of tinnitus will be assessed using a subjective rating~     scale and the minimum masking task.~   "
64932|NCT02717052|"~     The study at hand is the first to investigate ketamine's SERT binding in humans, by utilizing~     the highly selective SERT radioligand [11C]DASB and positron emission tomography.~   "
64933|NCT02717039|"~     The purpose of this research is to identify genomic markers that can predict heparin-induced~     thrombocytopenia (HIT), which is a very serious side effect to heparin. Heparin is commonly~     used to prevent blood clots and the investigators may be able to identify genomic markers~     which can be used to prevent heparin use in people who will get HIT.~   "
64934|NCT02717026|"~     Retinal blood flow measurement is of scientific and clinical value. For this purpose retinal~     vessel morphology (such as diameter, vessel wall thickness, etc) determination is crucial.~     Different imaging modalities might provide divergent results. Thus, quantification of such~     differences is valuable.~      The present study aims to reveal and quantify differences in vessel morphology between fundus~     photography, fundus angiography, and optical coherence tomography in health and disease.~   "
64935|NCT02717013|"~     This study will determine the effects of supplementing beta-hydroxy-beta-methylbutyrate (HMB)~     on body composition and strength changes during weight loss. When overweight and obese~     persons lose weight, and in particular in conjunction with dietary restrictions, muscle, bone~     mass, and muscle strength are also lost. HMB has been shown to preserve muscle mass and~     strength, and it is thought that HMB may also preserve muscle, bone, and strength during~     weight-loss.~   "
64936|NCT02717000|"~     Rationale:~      Non-alcoholic fatty liver disease (NAFLD) is the most widespread liver disorder in Western~     society (prevalence 20-30%). It is strongly associated with overweight and obesity. The~     majority of patients have simple steatosis. However, in about 15-30% of the subjects, a~     chronic inflammatory state develops that is referred to as non-alcoholic steatohepatitis~     (NASH), which leads to an overall increase in morbidity and mortality due to the progression~     to fibrosis, cirrhosis and in some cases, hepatocellular carcinoma (HCC). The term NAFLD~     comprises both simple steatosis and NASH. Most patients with NAFLD have no or few, mainly~     aspecific symptoms; and generally there is a silent progression of simple steatosis to NASH~     and in the end, liver-related morbidity and mortality.~      To date, liver biopsy is the most sensitive test for detecting and staging NAFLD, and is the~     only reliable method for differentiating between NASH and simple steatosis. However, the~     procedure of obtaining a liver biopsy is invasive and associated with patient discomfort,~     significant complications and high costs. In addition, liver biopsy is prone to sampling~     error and inter- and intra-observer variability, due to the small size of liver biopsy~     samples. This method is therefore not suitable for screening large numbers of subjects at~     risk, or for follow-up of patients with NASH over time. Hence, only subjects at high risk~     (usually based upon elevated aminotransferase levels, which is not specific for the presence~     of NASH) are biopsied, leading to an underestimation of NASH prevalence and undertreatment.~     Further insight into disease mechanisms and risk factors for NAFLD and in particular NASH is~     warranted, to enable early diagnosis, adequate therapy and preventive measures to improve~     health status of these individuals. Accurate and less invasive methods to evaluate NASH, and~     NAFLD, are urgently needed.~      Objective: The primary objective of this study is to establish non-invasive tools (e.g.~     biomarkers and imaging) to accurately diagnose patients with NASH. The secondary objective is~     to show an association between the levels of identified markers and disease severity.~      Study design:~      Eligible subjects will be included via the outpatient clinics Zuyderland in Heerlen, the~     Catharina hospital in Eindhoven and MUMC+ in Maastricht. A subset of eligible subjects has~     undergone a liver biopsy for clinical reasons. It is estimated that about 85% of subjects~     will be asked to undergo a biopsy for study purposes only. Liver biopsies for study purposes~     will be performed during a surgical procedure, e.g. bariatric surgery or cholecystectomy.~      Blood, faeces and exhaled air will be collected and a FibroScan (+CAP) will be performed~     during a study visit. An MRI will be performed, to estimate the degree of steatosis.~     Furthermore, anthropometric data (weight, height, abdominal and waist circumference and blood~     pressure (BP)) will be collected.~      The participants in the group undergoing liver biopsy during bariatric surgery will be asked~     permission to be approached for follow-up measurements 3 months post-surgery. As they will~     lose weight, which is associated with improvement of hepatic steatosis, this enables~     assessment of possible changes over time. A routine follow-up visit post-surgery will take~     place after 3 months. The follow-up measurements will be combined with this visit, minimizing~     the burden for the participant. The measurements will consist of blood, faeces and exhaled~     air collection and a FibroScan (+CAP) will be performed during a study visit. Furthermore,~     weight, height, BP and abdominal and waist circumference will be measured.~      Study population:~      Subjects with proven NAFLD by histology or NAFLD proven by imaging, who are undergoing~     surgery (i.e. bariatric surgery or cholecystectomy) will be asked to participate in this~     study. Furthermore, all subjects have to be between 18 and 65 years old.~      Main study parameters/endpoints:~      Non-invasive tool based on biomarkers and imaging to diagnose NASH.~   "
64937|NCT02716987|"~     The purpose of this study is to determine the relationship between TAK-831 plasma exposure~     and the extent and duration of brain D-amino acid oxidase (DAO) enzyme occupancy following~     single oral dosing of TAK-831 in healthy participants.~   "
64938|NCT02716974|"~     To assess the safety of treating men with oligometastatic prostate cancer with the following~     therapy: (1st) Systemic chemo-hormonal therapy with up to 6-months (~24 weeks) of neoadjuvant~     androgen deprivation and up to 6 cycles of chemotherapy, (2nd) definitive local tumor control~     with prostatectomy +/- adjuvant radiation therapy, and (3rd) consolidative stereotactic~     radiation to oligometastatic lesions. The men will receive a total of 1 year of androgen~     deprivation. Androgen blockade will be the same throughout the course of treatment.~   "
64939|NCT02716961|"~     It is still a challenge for urologic surgeon to prevent the post transurethral resection of~     bladder tumor (TURBT) recurrence of moderate-high risk non-muscle invasive bladder tumor.~     Adjuvant chemotherapy is a standard treatment for local progressive bladder tumor, which~     contains mainstream GC treatment scheme. It is common to observe clinically moderate-high~     risk NMIBC recurrence after routine intravesical instillation.Systematic chemotherapy can~     eliminate remained tumor cells especially those from mucosa basal cells so as to improve the~     prognosis of patients. Our clinical trial aims to investigate whether the utilization of~     combination of GC treatment scheme and epirubicin instillation would decrease the recurrence~     of moderate-high risk NMIBC.~   "
64940|NCT02716948|"~     This phase I pilot trial studies the side effects of stereotactic radiosurgery and nivolumab~     in treating patients with newly diagnosed melanoma that has spread to the brain or spine.~     Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high~     dose of radiation directly to the tumor to more precisely target the cancer. Monoclonal~     antibodies, such as nivolumab may interfere with the ability of tumor cells to grow and~     spread. Giving stereotactic radiosurgery together with nivolumab may be a better treatment~     for melanoma.~   "
64941|NCT02716935|"~     The purpose of this study is to assess the effect of a mixture of prebiotics included in a~     food supplement on microbiota diversity and functionality, and to explore its subsequent~     effects on linear growth velocity and morbidity.~   "
64942|NCT02716922|"~     Preterm birth remains the most common cause of perinatal morbidity and mortality. A short~     cervi- cal length on transvaginal ultrasonography has been shown to be one of the best~     predictors of preterm birth. In 2005 a meta-analysis by Berghella et al. showed that cervical~     cerclage does not prevent preterm birth (PTB) in women with short cervical lenght without~     prior PTB. However maybe the meta-analysis did not reach the statistical significance due to~     the small sample size~   "
64943|NCT02716909|"~     Spontaneous preterm birth (SPTB) remains the number one cause of perinatal mortality in many~     countries, including the United States. In singleton gestations a short cervical length (CL)~     on transvaginal ultrasound (TVU) has been shown to be a good predictor of SPTB.~      The cervical pessary is a silicone device that has been used to prevent SPTB. The efficacy of~     cervical pessary has been assessed in several populations including singletons with short CL,~     unselected twins, twins with a short CL, and triplet pregnancies. Several randomized clinical~     trials (RCTs) have been published, and several are ongoing. However, no consensus on the use~     of cervical pessary in pregnancy or guidelines for management have been assessed.~   "
64944|NCT02716896|"~     Currently the standard treatment of muscle invasive bladder cancer is the complete removal of~     bladder and adjacent organs, such as prostate or ovaries. Radical cystectomy is fraught with~     complications and risk of death. The researchers hope to learn if chemoradiation (i.e. using~     chemotherapy and radiation), also an acceptable treatment for muscle invasive bladder cancer,~     can be used a good alternative therapy option.~   "
64946|NCT02716870|"~     Fructose-containing sugars have been implicated in the epidemics of obesity, diabetes and~     related cardiometabolic disorders. This view is supported by lower quality evidence from~     ecological observations, animal models, and select human trials. Higher level evidence from~     controlled trials and prospective cohort studies have been inconclusive. Whether sugars~     contribute to cardiometabolic complications independent of their calories remains unclear. To~     address the uncertainties, the investigators propose to conduct a series of systematic~     reviews and meta-analyses of the totality of the evidence from controlled trials to~     distinguish the contribution of fructose-containing sugars from that of energy in the~     development of markers of cardiometabolic risk. The findings generated by this proposed~     knowledge synthesis will help improve the health of consumers through informing~     evidence-based guidelines and improving health outcomes by educating healthcare providers and~     patients, stimulating industry innovation, and guiding future research design.~   "
64947|NCT02716857|"~     The purpose of this study is to determine the analgesic efficacy of Egalet-002 twice daily~     (BID) in patients with moderate-to-severe chronic low back pain~   "
64948|NCT02716844|"~     Aim: Investigating the effects of Clinical Pilates Exercise on kinesiophobia, pain,~     functional status and quality of life of the patients diagnosed with osteoporosis.~      Method: 47 patients were assessed and randomly divided into 2 groups. Exercise group patients~     joined exercise program regularly that was held 3 times a week, 1 hour a day, during 6 weeks~     with physiotherapist. Control group patients continued their normal daily lives without any~     exercise. After 7 patients quit the study for various reasons, 40 women with primary~     osteoporosis (control group n=20, exercise group n= 20), completed the study and were~     assessed at the beginning and at the end of 6 weeks. As assesment' measurements Tampa~     Kinesiophobia Scale (TKS), Visual Analog Scale (VAS), Short Form McGill (SF-McGill), Pain~     Disability Index (PDI), Oswestry Disability Index (ODI), Berg Balance Test (BBT), Timed Up-~     Go Test (TUG), Chair Sit-Stand Test (CSST), Chair Sit and Reach Test (CSRT), Back Scratch~     Test (BST), Quality of life Questionnaire European Foundation for Osteoporosis (QUALEFFO-41),~     Hospital Anxiety and Depression Scale (HADS), Satisfaction with Life Scale (SLS) and Health~     Assesment Questionnaire (HAQ) were performed.~   "
64949|NCT02716831|"~     The purpose of the study is to test a novel, acceptance-based behavioral treatment for~     bulimia nervosa (BN) in adults. This treatment is a type of individual psychotherapy called~     Nutritional Counseling And Acceptance-Based Therapy (N-CAAT) that enhances existing cognitive~     behavioral therapy (CBT) for BN by incorporating acceptance-based behavioral strategies and~     nutritional counseling to help patients eliminate BN symptoms.~   "
64950|NCT02716818|"~     This study is a parallel arm, randomised, open-label study, including dose titration and~     admissions for four overnight stays for 24-hour endocrine profiles. It will compare the~     efficacy, safety and tolerability of Chronocort® with standard glucocorticoid replacement~     therapy in the treatment of congenital adrenal hyperplasia (CAH) over a treatment period of 6~     months. Dose titration decisions in both treatment groups will be made by a central~     independent physician, blinded to the treatment arm, using information generated from the~     24-hour endocrine profiles. Each treatment arm will be subject to the same titration rules~     throughout the study, ensuring that opportunities for optimisation and control of androgens~     are the same in both groups.~   "
64951|NCT02716805|"~     This is an open-label, multicenter, Phase 1 study of checkpoint therapy, tremelimumab and~     durvalumab, administered to subjects with multiple myeloma who are at high risk for relapse.~     Checkpoint therapy will be administered prior to and for 2 cycles post autologous stem cell~     transplant (ASCT). This will be followed by up to 6 additional monthly cycles of durvalumab~     alone.~   "
64952|NCT02716792|"~     This study will evaluate renal function in participants with metastatic bone disease due to~     breast cancer receiving intravenous (IV) infusions of ibandronate (Bondronat) 6 milligrams~     (mg), over either 15 minutes or 60 minutes, every 3 weeks. Efficacy and safety of ibandronate~     in the 2 groups of participants will also be compared. The anticipated time on study~     treatment is 7 months, and the target sample size is 318 individuals.~   "
64953|NCT02716779|"~     This study examined the influence of ribavirin on the initial virological response in~     treatment-naïve participants with chronic hepatitis C, genotype 1. Participants were~     randomized to 1 of 3 treatment groups to receive placebo, ribavirin monotherapy 1000~     milligrams (mg) to 1200 mg orally daily depending on body weight or pegylated interferon~     (PEG-IFN) alfa-2a (Pegasys®) 180 micrograms (mcg) subcutaneously (SC) weekly, for 6 weeks.~     Following the initial 6 weeks, all participants received combination therapy with PEG-IFN~     alfa-2a plus ribavirin (Copegus®) for 12 weeks. If there was an initial virological response~     after 12 weeks of combination therapy, treatment could be continued for a further 36 weeks~     outside of the study.~   "
64954|NCT02716766|"~     The purpose of this study is to determine if sorafenib, capecitabine and oxaliplatin (SECOX)~     regimen is more effective than sorafenib alone in the treatment of advanced liver cancer.~   "
64955|NCT02716753|"~     All couples planned for IVF will be asked to participate. After information and received~     informed consent they will be randomized into two groups.~      At the time for ovum pick up during an IVF procedure either half of the amount of seminal~     plasma or the same amount of physiological NaCl solution will be installed around the~     external cervical opening in vagina. The syringe with seminal plasma or physiological NaCl~     solution will be prepared according to a prearranged randomization list by a technician.~      The success rate will be the number of diagnosed pregnancies and live births.~   "
64970|NCT02716558|"~     It is a clinical trial which employs a split mouth design to assess the retention of a~     moisture tolerant resin based sealant and the ART(Atraumatic restorative treatment) sealants~     on a representative sample of 7- 12 year old school children of a district in Belgaum,~     Karnataka, India.~   "
64971|NCT02716545|"~     Gastrointestinal vascular malformation (GIVM), which is an important cause of acute or~     chronic gastrointestinal bleeding, consequently is in dire of effective treatment. The~     investigators' previous study first confirmed thalidomide treatment of GIVM bleeding was safe~     and effective. This trial intends to investigate the efficiency of endoscopic intervention to~     the hemorrhage due to GIVM. What more, the research tends to suggest standardizing clinical~     paths for small bowel bleeding due to GIVM.~   "
68222|NCT02673983|"~     The aim of this study is to evaluate FTRD (full-thickness resection device) in terms of~     obtaining full-thickness biopsies form the gastrointestinal tract endoscopically in the~     work-up of patients with gastrointestinal motility disorders.~   "
64956|NCT02716740|"~     Despite the demonstrable health and quality of life benefits, there are unknowns within~     consequences of obesity surgery. Weight loss composition is poorly understood. The objective~     is to have a significant loss of body fat and a limited loss of muscular weight.~      A cohort study in the nutrition unit at Toulouse University Hospital shows that 3 months and~     1 year after surgery, there are 2 phenotypes of patients. The first one is called 'little~     loss' and is defined by a contribution of muscular weight lower than 15% of the total weight~     loss. The other one is called 'big loss' and is defined by a contribution of muscular weight~     higher than 15% of the total weight loss. Causes of these different phenotypes are unknown~     for the moment.~      Some amino acids have an anabolic potential. Leucine induces a muscular protein synthesis in~     clinical situations like hepatic cirrhosis, and some populations like new born and older~     people.~      Assuming that, a leucine-enriched essential amino acid supplementation will have a benefit~     effect on the muscular mass. That is testing the influence of the quality of protein~     consumed, more than the quantity. An anabolic substance (amino acid here) can lead to gain of~     muscle only if it is associated to regular physical training, all patients will follow a~     physical training.~   "
64957|NCT02716727|"~     Purpose: To compare the quality of impressions made with a cordless gingival displacement~     procedure versus impressions made with a corded technique. The devices and materials used in~     both procedures are FDA-approved, marketed, and will be used according to label.~      Participants: Approximately sixty (60) adult patients who are treatment planned for indirect~     restorations (crowns) at the UNC School of Dentistry. Procedures (methods): Participants will~     be randomized to receive either the cordless gingival displacement procedure (Aquasil Ultra~     Cordless, Dentsply), or the corded technique (Ultrapak, Intradent) followed by impression~     with Aquasil Ultra, Dentsply. Participants will complete the Faces pain scale. Impressions~     will be photographed, digitally scanned, and evaluated.~   "
64958|NCT02716714|"~     This study evaluate the efficacy and safety of ingenol mebutate gel 0.015% on face and scalp~     & 0.05% on trunk and extremities in Korean patient with actinic keratosis.~   "
64959|NCT02716701|"~     Exercise therapy in MS patients has proven benefits on mobility, mood, motor function and~     quality of life. While the beneficial effects of exercise on cardiovascular and~     musculoskeletal function are well known, there has recently been increased focus on the~     positive effects of exercise on brain structure and function. The goal of this study is to~     determine whether exercise can promote beneficial changes in brain function in MS patients.~   "
64960|NCT02716688|"~     To investigate the efficacy and toxicity of S-1 with concurrent radiotherapy in older~     patients with esophageal cancer.~   "
64961|NCT02716675|"~     This study will evaluate the safety and efficacy of the human monoclonal antibody (mAb)~     VRC-HIVMAB060-00-AB (VRC01) in preventing HIV-1 infection among men and transgender (TG)~     persons who have sex with men, in North America, South America, and Switzerland.~   "
64962|NCT02716662|"~     The purpose of this study is to determine if AC-1204 is safe and tolerated in subjects with~     ALS. The reason why the investigator wants to use AC-1204 in patients with ALS is to~     determine if, by taking AC-1204, the body will make substances called ketone bodies. Further,~     if AC-1204 is well tolerated, the investigators want to change the amount the participant~     takes, to determine if the amount of ketone bodies in the blood increase in accordance with~     increases in the amount of AC-1204 the participant takes. The investigators want to do this~     study because when the investigators gave AC-1204 to mice with ALS, findings suggest the~     disease course is altered for the better and that the cause of this change is due to the~     presence of ketones in the blood. If AC-1204 can be proven to be safe and able to cause~     ketones to increase in the blood, the investigators will likely do subsequent studies to~     determine if the presence of ketone bodies will slow or stop the progression of the disease.~     However, this study is not designed to determine if AC-1204 will stop or slow the progression~     of ALS. It is designed to only determine if patients with ALS can tolerate AC-1204, if ketone~     bodies are produced and if the amount of ketone bodies produced increases with increasing~     dose.~   "
64963|NCT02716649|"~     In this project, we derive survival risk ratios (SRR) based on International Classification~     of Disease version 10 (ICD-10) injury codes to validate the ICD Injury Severity Score (ICISS)~     in data from four public university hospitals in India.~   "
64964|NCT02716636|"~     The purpose of the study is to investigate whether the speed of tenaculum placement affects~     perceived patient pain during office transcervical procedures.~   "
64965|NCT02716623|"~     The purpose of this study is to learn if bladder cancer patients can follow a diet and~     exercise program during treatment and whether the program will improve results of their~     treatment.~   "
64966|NCT02716610|"~     Pharmacokinetic (PK) and Pharmacodynamic (PD) dose-response investigation of Dance-501~     inhaled human insulin~   "
64967|NCT02716597|"~     The role of albumin in sepsis has been controversial for decades. Although hypoalbuminemia~     has been associated with worse outcomes in sepsis, definitive evidence does not exist that~     replacing albumin in these patients improves outcomes. However, subgroup analyses from large~     clinical trials indicate that albumin may reduce mortality in septic shock, and in~     particular, may reduce the time a patient requires vasopressor support. Given this~     background, we are conducting this study to evaluate the role of albumin replacement in the~     patient with resolving septic shock to determine if albumin administration reduces the time a~     patient requires vasopressor support, reduces the time required for central line, and~     ultimately whether any potential benefit in terms of reduction of vasopressor support is~     associated with ICU length of stay and other outcomes. The approach is unique from larger~     trials of albumin in that it is a septic shock study geared at a particular phenotype of the~     patient in septic shock and evaluating a specific intervention at a specific time point in~     the course of septic shock.~   "
64968|NCT02716584|"~     Impairments in social integration, characterized by low marriage rates, few friendships, and~     a high frequency of living alone, affect the vast majority of Veterans with schizophrenia.~     The primary aim of this proposal is to test the efficacy of a novel rehabilitation treatment~     approach, engaging in physical exercise, at improving two determinants of social integration~     which are impaired in schizophrenia: cognition and affect.~   "
64969|NCT02716571|"~     This study on manufacture of MG4101 (allogeneic natural killer cell) to use for~     Hepatocellular carcinoma(HCC) after Transarterial Chemoembolization(TACE) will be harvested~     WBC(white blood cell) and plasma from healthy donors, or plasma from healthy donors by~     leukapheresis or plasmapheresis procedure.~   "
64973|NCT02716519|"~     This study is designed to assess the comparative effectiveness of SANTYL® versus standard of~     care in the treatment of pressure ulcers and diabetic foot ulcers within the continuum of~     care of an ACO. After meeting study criteria, participants will be randomly assigned to apply~     Santyl or standard care to their pressure ulcer or diabetic foot ulcer for up to 6 weeks.~     Participants will be followed for one year from the date of randomization to assess ulcer~     status and ulcer complications.~   "
64974|NCT02716506|"~     The aim of this study is to investigate the safety and effectivity of pelvic organ prolapse~     (POP) surgery. In this multi center study the population consists of POP operations done in~     Finland year 2015.The study is prospective and validated questionnaires are used to measure~     the symptoms of POP and the quality of life before and six months after the operation.~     Methods and complications of surgery are reported by doctors in all 40 participant hospitals.~   "
64975|NCT02716493|"~     Exercise-based rehabilitation improves physical function, fatigue and quality of life in~     patients with thoracic neoplasia. Consequently, the need for rehabilitation across the~     continuum of care in oncology is growing rapidly. However, the implementation of this type of~     intervention is limited because of many barriers such as patients' symptoms and poor~     accessibility to programs. In this context, healthcare systems should develop and implement~     new approaches to dispense these services. Consequently, telerehabilitation is a promising~     strategy to improve access and adherence to rehabilitation.~      OBJECTIVES To investigate the feasibility, adherence and satisfaction of a home-based~     telerehabilitation program (TELERP) with real-time physiological parameters acquisition in~     patients with unresectable thoracic neoplasia receiving chemotherapy and to explore its~     effects on patients' functional capacity.~      METHODS Five patients receiving chemotherapy followed an 8-week TELERP using real-time~     monitoring combined with interactive exercises. The TELERP included supervised (15) and~     unsupervised (9) strengthening and cardiovascular exercise sessions at a rate of 3~     sessions/week. The feasibility of the TELERP, adverse outcomes, technical issues, program~     adherence and satisfaction were analysed. Prior to and after the program, a six-minute~     walking test (6MWT), a timed up and go (TUG) and a timed stair test (TST) were done to assess~     functional capacity~   "
64976|NCT02716480|"~     The goal of clinical trial is to evaluate the impact of use of health-connected devices and~     of an Internet-based Intensive follow-up on physical activity recovery during the 6-month~     period after bariatric surgery in obese patients.~   "
64977|NCT02716467|"~     Living with breast cancer and forms of treatment, among them radiation therapy can cause both~     side effects such as pain, fatigue and skin changes that affect the well-being, as anxiety,~     feelings of isolation and changes in routine, which generate existential conflicts and allow~     the origin of the spiritual anguish phenomenon, which in turn, aggravates the physical and~     emotional symptoms and the ability to fight the disease. Thus, this study aims to evaluate~     the effect of intercessory prayer on levels of spiritual distress, religious / spiritual~     coping, psychological morbidity (anxiety and depression) and amylase levels salivary present~     in patients with breast cancer radiotherapy.~   "
64978|NCT02716454|"~     This study compares the efficacy of early surgical with medical treatment in patients with~     ileocaecal uncomplicated Crohn's disease. The patients with affected short part of terminal~     ileum will be randomized either for laparoscopic ileocaecal resection or standard step-up~     pharmacological therapy.~   "
64979|NCT02716441|"~     This proposal's objective is to challenge and expand the current definition of rotator cuff~     healing by investigating tendon retraction - broadly defined as medial translation of the~     repaired tendon away from the bone with or without a defect - as a common and clinically~     predictive structural outcome following rotator cuff repair. The investigators' central~     hypothesis is that failure with continuity is a common yet unrecognized structural phenomenon~     of rotator cuff healing that is significantly and meaningfully correlated with clinical~     outcomes. The investigators' approach is to characterize tendon retraction using an array of~     implanted radio-opaque markers, and investigate its relationship to pre-operative tissue~     quality (MRI), post-operative repair structural integrity (MRI) and clinical outcomes in a~     125-patient prospective cohort study. These patients will complete (1) validated~     questionnaires and range of motion testing pre-operatively, (2) CT imaging at day of surgery,~     3 weeks, and 3, 6, 12 and 24 months post-operatively, (3) MRI at 3 weeks and 3, 6, 12 and 24~     months post-operatively and (4) questionnaires, range of motion and strength testing at 3, 6,~     12 and 24 months post-operatively.~   "
64980|NCT02716428|"~     Phase 2 study designed to assess the safety, efficacy, and pharmacokinetics of Faldaprevir~     and TD-6450 alone or in combination with other antivirals for a 12-week treatment duration in~     treatment-naïve participants with genotype 1b hepatitis C virus (HCV) infection.~   "
64981|NCT02716415|"~     The purpose of this study is to compare the efficacy and safety of Calmoseptine Ointment and~     Desitin Maximum Strength 40% Zinc Oxide Diaper Rash Paste in the treatment of diaper~     dermatitis among Neonates and Infants.~   "
64982|NCT02716402|"~     The purpose of the study is to examine previously examined patients with cyanotic congenital~     heart disease to assess how many of the patients have obtained additional blood clots since~     they were examined 8 years ago.~   "
64983|NCT02716389|"~     The measurement of cervical spine range of motion (ROM) figures among the most common aspects~     of clinical diagnosis. Good reliability has been demonstrated for assessments using~     ultrasonic movement analysis systems, such as Zebris CMS 70 (Isny, Germany). However, in~     contrast to combined measurements of movement amplitudes (e.g., flexion plus extension in the~     sagittal plane), separating the respective components provides less reliable results. Current~     research suggest that this is due to the participants' determination of the zero position.~     This position is influenced by possible disposed treatments and, in particular, by the~     subject in case of subjective determination. The present study therefore aims to examine the~     test-retest reliability of separate ROM assessments using a bulls eye spirit meter.~      Twenty healthy participants will be included in the trial that adopts a two-armed randomized,~     crossover design. With a washout-period of one week in between, each subject participates in~     two sessions in a randomised order. In both sessions, cervical ROM (flexion/extension,~     rotation, lateral flexion) will be measured twice (with a five-minute wait period). In all~     measurements, the zero position will be determined by means of a bulls eye spirit level. The~     difference of the two sessions consists in the design of the waiting period. In one session,~     the subjects will keep the mask carrying the ultrasound markers on their head. In the other~     session, the mask will be removed during the break.~   "
64985|NCT02716363|"~     Current guidelines recommend the use of rotational atherectomy (RA) for preparation of~     heavily calcified or severely fibrotic lesions that cannot be crossed by a balloon or~     adequately dilated before planned stenting (bailout situations). RA emerged in the 1990s as~     one of several tools to treat luminal obstruction via physical removal of plaque. Although~     initially explored as an alternative to balloon angioplasty, RA has shown favorable acute~     results in facilitating stent delivery and adequate expansion, particularly those affected by~     heavy calcification.Drug-eluting stents (DES) have substantially reduced re-stenosis rates in~     randomized clinical trials evaluating simple de novo coronary artery lesions and have also~     shown favorable results when implanted in complex lesions and patients, but higher event~     rates are observed when treating such subsets compared with simple lesions even with newer~     generation DES. However, there are limited data on evaluating the safety and effectiveness of~     RA followed by DES implantation for heavily calcified lesions in contemporary practice.~     Recent randomized controlled trial shows that RA before paclitaxel eluting stent implantation~     as first generation DES was not superior to paclitaxel eluting stent implantation without~     prior RA in reducing the primary endpoint of in-stent late luminal loss at 9 months,~     indicating that RA does not increase the efficacy of DES in patients with moderate to severe~     calcified lesions. However, there were only 15 (12.5%) crossovers from standard therapy to~     rotablation because of failure of balloon or stent delivery or suboptimal balloon expansion~     despite the use of a noncompliant balloon. Accordingly, procedural and fluoroscopy times were~     longer in the elective RA and procedural complications occurred equally in both elective RA~     and bailout RA. These findings might cause by a substantial portion of enrolled population~     have moderate calcified lesions, but not severe calcified lesions. In particular,~     everolimus-eluting stent (EES) as newer generation DES could act synergistically in heavily~     calcified lesions as RA could avert stent coating damage and EES could effectively suppress~     neointimal proliferation. Therefore, we compare in-hospital and long-term efficacy or safety~     of elective RA versus bailout RA and low-volume operator versus high-volume operator in~     patients with severe calcified lesions treated with EES.~   "
64986|NCT02716350|"~     To investigate the potential of B-GOS to beneficially influence the wellbeing and ageing in~     healthy adults (52-65 years old). The study will consist of a 4 month randomised double blind~     parallel treatment period with either B-GOS of Placebo, and 1 month follow up period without~     treatments.~   "
64987|NCT02716337|"~     The prevention of postnatal growth failure in very low birth weight (VLBW) preterm infants is~     of utmost importance. Standard fortification is the most commonly used supplementation~     practice but it does not consider the native variability of human milk. Data on efficacy and~     safety of prolonged target fortification are scarce. The investigators performed a~     prospective interventional study in VLBW preterm infants, exclusively fed with human milk, to~     test efficacy and metabolic safety of target fortification in these preterm infants.~   "
64988|NCT02716324|"~     The purpose of this study is to explore whether using an online patient portal plus a Care~     Manager is more effective than using an online portal alone in managing care for children~     with ADHD. Doctors at The Children's Hospital of Philadelphia currently use the online~     patient portal to help gather information from parents and teachers on ADHD symptoms,~     treatment, and medication side effects. The Care Manager is a person who meets with~     participants during the study to discuss their child's ADHD care. The Care Manager~     communicates with the child's doctor and teacher to communicate a parent's goals and~     preferences for their child's ADHD care.~   "
64989|NCT02716311|"~     Until recently, the first line treatment of metastatic Non Small Cell Lung Cancer (NSCLC) was~     a platine-based chemotherapy. It has been changed by the discovery of EGFR (Epidermal Growth~     Factor Receptor) mutations and associated treatment with Tyrosine Kinase Inhibitor (TKI) of~     EGFR. The superiority of EGFR TKI over chemotherapy for EGFR mutated patients has been proved~     in several phase III trials with gefitinib, erlotinib or afatinib.~      Nevertheless, all patients will progress after 9 to 12 months of treatment due to the~     appearance of a treatment resistance.~      Afatinib is an irreversible EGFR TKI. It binds to its receptor permanently.Contrary to~     erlotinib and gefitinb which inhibits only EGFR, afatinib inhibits the kinase activity of all~     HER family (Human Epidermal growth factor Receptor). Nevertheless, there is no proof that~     afatinib delay the appearance of resistance.~      Cetuximab is a monoclonal antibody which binds specifically with EGFR. The double inhibition~     of EGFR by afatinib and cetuximab has demonstrated its efficacy in pre-clinical models. The~     hypothesis of this study is that the combination between cetuximab and afatinib will permit~     to delay or decrease the appearance of resistances.~   "
64990|NCT02716298|"~     This is a study to evaluate the performance of fanfilcon A lens when worn on a daily wear~     modality over approximately 1 month in comparison to the lotrafilcon B lens.~   "
64991|NCT02716285|"~     Peppermint oil has shown to be effective in the treatment of Irritable Bowel Syndrome (IBS)~     symptoms in several meta-analyses. However, the level of evidence is moderate and peppermint~     oil remains relatively under-used in IBS. Therefore, the investigators will conduct a~     multicenter randomized, placebo controlled trial to investigate the effects of an eight-week~     peppermint oil treatment in IBS patients according to current European Medicines Agency (EMA)~     / US Food and Drug Administration (FDA) guidelines. To improve efficacy and to reduce side~     effects, the investigators aim to study the use of a new peppermint oil formulation, a~     colon-targeted-delivery capsule that will release the oil in the (ileo-) colonic region~     specifically.~   "
64992|NCT02716272|"~     The sponsor raise the hypothesis that inhibition of immune PD-1+/- CTLA-4 check-point(s)~     would delay tumor progression in patients with unresectable MPM, experiencing disease~     progression after one or two lines of chemotherapy including at least first-line with~     pemetrexed and platinum, without altering significantly the quality of life of patients.~   "
64993|NCT02716259|"~     The purpose of this study is to investigate whether basic periodontal therapy aim to reduce~     subgingival levels of Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans, has~     an impact on the vascular function of patients suffering from established cardiovascular~     disease.~   "
64994|NCT02716246|"~     Open-label, dose-escalation clinical trial of scAAV9.U1a.hSGSH injected intravenously through~     a peripheral limb vein~   "
65008|NCT02716051|"~     Magnetic Resonnace Imaging (MRI) and Positron Emission Tomography (PET) can be both used in~     detection of nodes in patients with cell lung cancer (NSCLC).~      However, the cardiorespiratory synchronization in the MRI, allowing acquisition of~     synchronous images with breathing and heart movements should increase the sensitivity of~     detection of pathologic mediastinal lymph nodes.~      Given its high sensitivity, whole-body MRI with diffusion could possibly be at least as~     informative as PET, while being less expensive, not radiant.~      The purpose of this study is to evaluate the performance of whole-body MRI with diffusion~     with cardiorespiratory synchronization, on the detection of mediastinal nodes (which are~     known to be less well detected by MRI) compared to PET.~   "
65023|NCT02715856|"~     The goal of this study is to learn about performing follow-up care using mobile devices~     (smartphones or tablet computers) after surgery.~      This is an investigational study.~      Up to 60 participants will be enrolled in this study. Up to 12 clinicians will also take part~     in this study. All will take part at MD Anderson.~   "
64995|NCT02716233|"~     A still major question in the field of acute lymphoblastic leukemia (ALL) in children - an~     extremely heterogeneous disease though curable in 80-90% of children and 70-80% of the~     adolescents - is the optimal use of L-asparaginase (ASNase). It is known that administering~     ASNase results in the depletion of asparagine circulating in the blood, which starves the~     leukemic cells and results in their death. But indeed the use of ASNase varies between~     protocols considering the different brands, the dose and the administration modalities.~     Oncaspar (PEGylated E. coli asparaginase, pegaspargase) was thus developed with the goal of~     reducing the immunogenicity of the native ASNase.~      This is a French prospective multicentric cohort study of children and adolescents with ALL,~     stratified on (i) the type of ALL ( B vs T) and (ii) the anticipated risk (stratified in 3~     groups for childhood B-cell precursor (BCP)-ALL and 2 groups for T-cell ALL).~      It aims to answer to two different issues:~        1. Randomized question: what is the best way to administer pegaspargase? A cohort of~          children and adolescents with standard or medium risk ALL will be randomized to receive~          during induction either one infusion of ONCASPAR® 2500 IU/m2 at D12 or two infusions of~          ONCASPAR® at 1250 IU/m2 each at D12 and D26. Patients will then receive 2500 IU/m2 or~          1250 IU/m2 per dose during consolidation and delayed intensification according to the~          initial arm of randomization.~        2. Non randomized question: In the High/Very High Risk groups, a non randomized~          intensification of the scheme of asparaginase administration is proposed during~          induction therapy: 2 infusions of 2500 IU/m2/day (D12 and D26) will be administered. All~          patients will receive 2500 IU/m2 per dose during consolidation and delayed~          intensifications.~   "
64996|NCT02716220|"~     BIOSOLVE-III Study is a pre-market, prospective, multi-center trial to assess the acute~     clinical performance of the DREAMS 2G Drug-Eluting Coronary Scaffold in de novo coronary~     artery lesions.~   "
64997|NCT02716207|"~     The maximum tolerated dose on locally advanced unresectable pancreatic tumor treated with~     CyberKnife SBRT will be evaluated.~   "
64998|NCT02716194|"~     1. To assess tolerability and safety of BAX 826 after a single infusion in previously~          treated patients (PTPs) with severe hemophilia A~        2. To determine the pharmacokinetic (PK) parameters of BAX 826 compared to ADVATE~        3. To evaluate immunogenicity of polysialic acid linked to Factor VIII (FVIII)~   "
64999|NCT02716181|"~     A Double-Blind Randomized Placebo-Controlled Trial to Evaluate the Efficacy of the Атопик~     Soothing Cream in Children with Mild to Moderate Atopic Dermatitis~   "
65000|NCT02716168|"~     Background International guidelines underline the importance of strengthening the~     coordination and continuity of cancer care. The different roles of general practitioners and~     oncologists with regard to treatment, follow-up and rehabilitation during and after cancer~     treatment are often obscure to cancer patients. Parallel courses of healthcare are often~     taking place instead of coordinated care characterized by continuity and partnership between~     care providers. Patients may feel uncertain about the health professionals' skills and area~     of responsibility. Healthcare seeking and support during and after cancer treatment may,~     therefore, be inappropriate, leaving patients feeling insecure and lost between care~     providers.The study aims to design and evaluate a new way of communication and shared~     decision-making that brings the patient, the oncologist and general practitioner together in~     a shared video-consultation in the early phase of chemotherapeutic treatment. The effect of~     the intervention in addition to usual care will be tested in a randomized controlled trial at~     Vejle Hospital in the Region of Southern Denmark. Based on sample size calculation,~     investigators intent to include 300 patients at the Department of Oncology and their general~     practitioners. Results and process outcomes will be evaluated qualitatively and~     quantitatively, questionnaires to patients, general practitioners and oncologists, and data~     from registers.~   "
65001|NCT02716142|"~     the aim of the study is To compare the effectiveness of rectally administered prostaglandin~     E1 synthetic analogue (misoprostol) 400 microgram versus sublingually administered~     misoprostol before myomectomy to decrease blood loss during and after the operation.~   "
65002|NCT02716129|"~     The primary endpoint of this study is to investigate the effect of adding nalbuphine to~     intrathecal morphine on quality of postoperative analgesia and Morphine related side effects~     post- cesarean delivery.~   "
65003|NCT02716116|"~     The purpose of this phase 1/2 study is to evaluate the safety, pharmacokinetics, and~     anti-tumor activity of oral AP32788 in patients with non-small cell lung cancer (NSCLC). The~     trial will be conducted in two parts: a dose escalation phase, followed by an expansion~     phase. The goal of the dose escalation phase is to determine the safety profile of orally~     administered AP32788, including the maximum tolerated dose (MTD), dose limiting toxicities~     (DLTs), recommended phased 2 dose (RP2D) and pharmacokinetic profile. Once the RP2D is~     established, the expansion phase will assess the preliminary anti-tumor activity of AP32788~     in 4 histologically and molecularly defined NSCLC cohorts. Approximately 105 patients will be~     enrolled.~   "
65004|NCT02716103|"~     In this study, the investigators seek to evaluate bone marrow and blood samples and treatment~     responses to see if Minimal Residual Disease (MRD) can be used as a predictive method of~     response to treatment in amyloidosis.~   "
65005|NCT02716090|"~     This study evaluates the non-inferiority of the product Dalap Duo® compared to Epiduo®~     medicine to treat acne. Half of the participants will receive Dalap Duo®, while the other~     half will receive Epiduo®.~   "
65006|NCT02716077|"~     Adult patients with histologically proven melanoma who will be treated with pembrolizumab~     will undergo FDG PET/CT scan as an early evaluation of response to therapy. Changes in FDG~     uptake will be correlated with lab and pathology results.~   "
65007|NCT02716064|"~     TAPESTRY-CM pilot study is a 12-week pilot test of the TAPESTRY-CM using a web application~     (APP) to help patient manage their diabetes and hypertension and other chronic conditions by~     assisting them in setting goals and connecting them to their healthcare team.~   "
65009|NCT02716038|"~     This is a research study to test the effectiveness of nab-paclitaxel + carboplatin +~     MPDL3280A for treatment of non-small-cell lung carcinoma (NSCLC), which is a type of lung~     cancer. The study aims to determine if chemotherapy combined with immune-based therapy can~     lead to improvement in tumor response rates over historical response rates with chemotherapy~     alone.~   "
76373|NCT02567318|"~     The purpose of this prospective study is to investigate the degree of association between the~     volume of important pain-relevant structures in the brain and the size of the areas of~     secondary hyperalgesia.~   "
65010|NCT02716025|"~     Fifty consecutive patients with symptoms suggestive of peptic ulcer disease were included.~     All underwent complete clinical evaluation, laboratory investigations, upper gastrointestinal~     endoscopy and rapid urease test. Measurement of serum zinc level was done for all the~     included patients in addition to twenty five age and sex matched healthy control subjects.~   "
65011|NCT02716012|"~     This is a First in Human study of a new single agent (MTL-CEBPA) in patients with advanced~     cancer of the liver. The study is in two parts: dose escalation followed by a dose expansion;~     both parts of the study will recruit advanced hepatocellular carcinoma patients with~     cirrhosis. All participants will be refractory to or ineligible for loco-regional therapy~     including surgery, radiofrequency tumour ablation, transarterial chemoembolisation or~     sorafenib.~      MTL-CEBPA consists of a double stranded RNA formulated into a SMARTICLES® liposomal~     nanoparticle and is designed to activate the CEBPA gene.~   "
65012|NCT02715999|"~     The purpose of this research study is to find the best way to decrease pain in children whom~     have had low abdominal surgery. Investigators will perform two technique of trunk block;~     Transversus abdominis plane or Quadratus lumborum block .The method used is often chosen by~     which one the doctor has more experience using. The Investigator plans to find out if one of~     the methods is more effective and/or safer than the other method.~      The results of this study will help learn how to best control pain in children having surgery~     low abdominal surgery.~   "
65013|NCT02715986|"~     Electroconvulsive therapy (ECT) is a non-pharmacological treatment used in resistant~     depression whose effectiveness has been demonstrated. However, the brain mechanisms~     underlying this therapeutic effect remain unclear. Many animal studies show a neurotrophic~     action of ECT on the hippocampus: increased neurogenesis, synaptogenesis, proliferation of~     glial cells. In addition, functional imaging of resting state type have shown, among~     depressed patients after ECT, increased functional connectivity . These results were~     reinforced by the recent work of Perrin (2012). In view of this a priori contradictory, it~     seems appropriate to continue research neuroanatomical correlates subtending neurofunctional~     processes responsible at the same time improving the clinical depressive. The investigators~     suggest using an original technique never used in this type of population: Functional~     magnetic resonance imaging (fMRI) or multimodal structural-functional. This method will allow~     us to study the impact of ECT on brain structures involved in major depressive disorder:~     hippocampus.~   "
65014|NCT02715973|"~     Children (Exclusively breast fed: 6mo - 3yrs, and who are not exclusively breast fed 3mo to 3~     yrs) with infantile cholestasis syndrome will be randomized to either recieve indigenously~     prepared oral nutritional supplement (energy dense supplement appox. 2 kcal/mL, prepared from~     locally available, affordable, socially acceptable food items - milk, sugar, edible coconut~     oil, egg and custard powder as base) in addition to standard nutritional counseling by a~     trained dietician (Group A). The control group (Group B) in comparison will receive standard~     nutritional counseling from a trained dietician but will not receive any additional~     nutritional supplement. All the children will be followed up at 1 month, 3 months, 6 months,~     9 months and 1 year after inclusion. Clinical, nutritional assessment and laboratory data~     will be collected at each visit. Additionally IL-6 levels will be done at each visit in~     children of both arms of the intervention group.~      The outcomes of interest will be growth and improvement of nutritional status parameters,~     hepatic morbidity (ascites, gastrointestinal bleeding, encephalopathy, {SBP (Spontaneous~     Bacterial Peritonitis), HRS (Hepatorenal Syndrome), etc and outcome (improvement, death or~     Liver Transplantation}.~      All children will receive individualized standard treatment for infantile cholestasis~     syndrome including vitamin supplements/endotherapy/ beta blockers/ prophylaxis for SBP~     (Spontaneous Bacterial Peritonitis)/cholangitis (to at risk children) and drug therapy~     wherever indicated (steroids/ copper chelation/ UDCA).~   "
65015|NCT02715960|"~     In an early clinical research, 138 patients completed the treatment of Psoriasis Vulgaris by~     Acitretin Capsules in 8 weeks, the results indicate 75 cases effectively (54.3%), 50 cases~     invalid(36.2%), 13 cases serious(9.4%). To investigate the influence of genetic factors on~     the curative effect and find the relationships between genetic variants and the response of~     Acitretin Capsules to treatment of Psoriasis Vulgaris.~   "
65016|NCT02715947|"~     To investigate the influence of genetic factors on the curative effect , to find the~     relationships between genetic variants and the response of Methotrexate to treatment of~     Psoriasis Vulgaris.~   "
65017|NCT02715934|"~     Diabetes education is a very important part of diabetes care. Most people with diabetes~     receive care in primary care practices where diabetes education is not always available. This~     project tests a model designed to improve access to diabetes education services.~   "
65018|NCT02715921|"~     Fitness in patients with Cystic fibrosis (CF) is an important biomarker associated with~     higher survivability and improved quality of life. CF patients are encouraged to maintain an~     active lifestyle, however, while physicians are able to prescribe airway clearance measures~     or specific medications, there is no prescription for exercise or avenue to promote exercise~     outside the clinic or hospital.~      The advent of ubiquitous computing has transformed the landscape of healthcare delivery. Thus~     far, exercise training in CF have either required patients travel to a gym or relied on home~     visits or telephone calls. Virtual visits provide a novel and innovative platform to deliver~     a live stream of exercise sessions with two-way video and audio capabilities, allowing~     individualized attention to exercise for CF patient from the comfort and privacy of their~     homes. Applications of tele-exercise, or tele-rehabilitation, have been shown to be as~     effective as in conventional physical therapy following orthopedic surgeries and, in stroke~     patients, to optimize patient outcome by prolonging duration of treatment and preventing the~     observed decline after the termination of therapy. For CF patients, the latter is especially~     important given the impact of hospitalizations for acute exacerbations on exercise tolerance.~     In this particular population, where cross-contamination risks limit use of group exercise~     activity, using two-way video telecommunication allows participation in exercise programs~     while adhering to the standards of CF management regarding infection control.~      This study would be the first to evaluate implementing tele-exercise and remote monitoring~     program on pediatric CF patients. Our pediatric CF patients will be enrolled in a six-week~     exercise program that is streamed live from an instructor into their computers at home via a~     HIPAA compliant telemedicine platform. Remote monitoring devices, such as accelerometers and~     wireless heart rate monitors, will evaluate baseline habitual activity and intensity of~     exercise, respectively. The goal of this study is to show that tele-exercise program is a~     feasible and convenient and cost-effective method to enhance CF care for our patients.~   "
65019|NCT02715908|"~     To evaluate the long-term safety including immunogenicity and efficacy of LBEC0101 50 mg~     subcutaneous weekly injection when co-administered with MTX~   "
65020|NCT02715895|"~     Compared with breast milk and another commercially available formula, infants' growth rate~     after 12 weeks' Friso formula with different ways of processing feeding will be assessed.~   "
65024|NCT02715843|"~     This is an active treatment, extended access study open solely to those subjects who have~     successfully completed the Core and Repeat Dosing portions of the MT-3724_NHL_001_US clinical~     study and who, in the investigator's judgment, (i) have not had progressive disease while on~     MT-3724 treatment (i.e.; have shown a complete or partial response or stable disease), (ii)~     have experienced no clinical or laboratory toxicities that would contraindicate further~     MT-3724 dosing and (iii) have no acceptable and better alternative treatment available to~     them.~   "
65025|NCT02715830|"~     It is a randomized study that intend to enroll 80 bellow-the-knee angioplasty procedures in~     which 40 procedures to treat one artery (standart) or more than one artery in the same~     procedure.~      The aim of this study is to know if this strategy increase healing velocity and limb salvage.~   "
65026|NCT02715817|"~     The purpose of this study is to determine the effects of the use the Nintendo Wii® (NW) and~     conventional therapeutic exercises in the rehabilitation of balance and gait of the~     post-stroke patients and the impact on quality of life.~   "
65027|NCT02715804|"~     The purpose of this study is to compare the efficacy and safety of PEGylated Recombinant~     Human Hyaluronidase (PEGPH20) combined with nab-paclitaxel plus gemcitabine (PAG treatment),~     compared with placebo combined with nab-paclitaxel plus gemcitabine (AG treatment), in~     participants with hyaluronan (HA)-high Stage IV previously untreated pancreatic ductal~     adenocarcinoma (PDA). Participants will be randomized in a 2:1 ratio to PAG or AG treatment.~   "
65028|NCT02715791|"~     The TAPESTRY-HC-DM approach is designed to support self-management of chronic disease by~     strengthening connections between patients and the primary healthcare system through health~     connectors -both volunteers and technology including the TAPESTRY Healthy Lifestyle App and~     McMaster Personal Health Record (PHR). It will explore whether strengthening primary care~     connections across patients, providers, and community organizations through TAPESTRY-HC-DM -~     i.e., the deployment of volunteer health connectors coordinated by a community organization,~     the use of the TAPESTRY Healthy Lifestyle e-Application by patients, and care coordination~     processes by the interprofessional primary healthcare team - can increase self-efficacy in~     managing chronic conditions.~   "
65029|NCT02715778|"~     Although the last decade has brought major advances with respect to our knowledge of certain~     risks associated with fetal exposure to psychiatric medications, critical information~     regarding the long-term neurobehavioral impact of fetal exposure is lacking. With a~     prevalence rate of selective serotonin reuptake inhibitor (SSRI) use across pregnancy in~     Western countries noted to be as high as 5-8%, this study aims to close the gap in knowledge~     regarding long-term neurobehavioral sequelae of in utero exposure to this class of~     antidepressants. Importantly, the assessment of the impact of antenatal psychotropic~     medication use must be conducted with an appreciation of the potential direct and indirect~     effects of maternal psychiatric illness during pregnancy and throughout childhood. The~     outcomes of this study will help to inform the care of reproductive age women treated with~     psychiatric medications as they, along with the clinicians prescribing for them, weigh the~     relative risks of using these agents during pregnancy.~   "
65030|NCT02715765|"~     Schizophrenia is a serious mental health disorder that affects approximately 1% of the~     population. Auditory hallucinations are present in as many as 50-75% of patients with this~     diagnosis. The hallucinations experienced by patients vary greatly and can severely impact an~     individual's ability to function on a daily basis. In approximately 25-30% of these patients,~     medication is an ineffective mechanism for managing these symptoms. These hallucinations are~     known as medication refractory auditory hallucination (MRAH). For those whose auditory~     hallucinations do not respond to medication, non-surgical brain stimulation (NBS) has~     recently shown promise as a therapeutic intervention. Two specific types of NBS, called~     transcranial direct current stimulation (tDCS) and transcranial random noise stimulation~     (tRNS), seem particularly well suited to treating MRAH. They have yet to be compared to each~     other in large samples of patients with MRAH. The goal of the study is to investigate whether~     tRNS and tDCS are effective in the treatment of MRAH and if one is better than the other when~     compared directly.~   "
65031|NCT02715752|"~     This study measured the changes in health-related complaints by analyzing charts of~     individuals, who are infected with a latent virus, who have used Gene-Eden-VIR/Novirin.~   "
65032|NCT02715739|"~     This study aims to compare the predictive performance of two different approaches of the~     international classification of disease injury severity score (ICISS) using data from four~     public university hospitals in urban India.~   "
65033|NCT02715726|"~     Primary Objective:~      To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab in~     comparison to ezetimibe as add-on therapy to stable maximally tolerated daily statin therapy~     in high cardiovascular (CV) risk patients with hypercholesterolemia in Asia.~      Secondary Objectives:~        -  To evaluate the effect of alirocumab on other lipid parameters: eg, Apolipoprotein (Apo)~          B, non-HDL-C, total cholesterol (TC), lipoprotein a (Lp[a]), high-density lipoprotein~          cholesterol (HDL-C), triglycerides (TG), and Apo A-1.~        -  To evaluate the safety and tolerability of alirocumab.~        -  To evaluate the development of anti-alirocumab antibodies.~        -  To evaluate the pharmacokinetics (PK) of alirocumab.~   "
65034|NCT02715713|"~     The primary goal of this pilot study is to investigate the association between testosterone~     deficiency and the presence of abnormalities in the function of the autonomic nervous system.~     If such association exists, then we will investigate the effect of testosterone replacement~     therapy on correcting these abnormalities.~   "
65035|NCT02715700|"~     This study will evaluate the effects of multiple doses of MK-1439 (doravirine) on the~     pharmacokinetics of methadone in participants requiring methadone maintenance therapy. The~     primary hypothesis is that the Area Under the Concentration-Time curve to 24 hours (AUC0-24)~     of (R)-methadone is similar when a maintenance regimen of methadone is administered with or~     without multiple daily doses of MK-1439.~   "
65066|NCT02715297|"~     This multi-center randomized controlled phase II trial will investigate the impact of~     stereotactic fractionated radiotherapy to the resection cavity of complete resected recurrent~     glioblastoma on progression free survival. As secondary endpoints, overall survival, safety~     and toxicity as well as early response criteria on MRI, quality of life and neurocognitive~     function will be assessed. Chemotherapy will not be part of the protocol, however, additional~     treatment will be possible upon investigators best choice.~   "
65036|NCT02715687|"~     Post-operative atrial fibrillation (POAF) is the most common complication encountered after~     cardiac surgery; reports show POAF to occur in ~ 35% of patients after CABG. Prophylactic use~     amiodarone was found to be effective, however, due to serious extracardiac adverse effects~     therapy is probably appropriate just for patients at high risk for POAF.~      the common practice for management of POAF is treatment with intravenous Amiodarone until~     return to sinus rhythm, following which the drug is given orally. Our protocol involves~     continued treatment with amiodarone for 30 day post-discharge from the hospital in a dose of~     200mg per day.~      This protocol is a common practice in many cardiac surgical departments worldwide,~     nevertheless, it is not evidence-based protocol and it was never examined as such.~      This study is a randomized placebo controlled trial, to evaluate the requirement for~     post-discharge treatment with oral Amiodarone.~   "
65037|NCT02715674|"~     This study will compare the effectiveness of postoperative incentive spirometry and~     noninvasive mechanical ventilation on pulmonary functions after craniotomy in 60 patients.~     Patients were randomized into a control group (G-K, n:20), an IS group (G-IS, n:20) and a~     CPAP (continuous positive airway pressure) group (G-CPAP, n:20)~   "
65038|NCT02715661|"~     This project will examine the association between (cardio)vascular disease, blood supply to~     the brain, and cerebrovascular endothelial activation. Also, we will investigate the impact~     of exercise rehabilitation on brain vascularization, cerebrovascular endothelial function and~     blood flow control.~   "
65039|NCT02715648|"~     The investigators propose to conduct a randomized controlled trial to evaluate whether~     administration of phenazopyridine prior to the procedure decreases office cystoscopy time.~     Women undergoing in-office cystoscopy at Boston Urogynecology will be recruited.~   "
65040|NCT02715635|"~     The principal research objective is to determine whether inorganic nitrate in the form of~     beetroot juice compared to placebo control prevents the systemic inflammation that underlies~     typhoid vaccine-induced endothelial dysfunction~   "
65041|NCT02715622|"~     The objective of this prospective, multi-center post-market study is to prospectively collect~     uniform, evidence based outcomes for patients undergoing open, laparoscopic or robotic~     assisted hernia repair.~      The outcomes that will be collected include various routine clinical parameters, short term~     patient reported outcomes (quality of life, pain scores) and long term hernia recurrence~     information. Patients will be treated according to standard of care at the surgeon's~     institution and patients will be followed up to collect information related to complications~     information and patient satisfaction associated with the hernia repair procedure.~   "
65042|NCT02715609|"~     The proposed study will be a multi-institutional, phase I/II study of disulfiram (DSF) for~     patients with presumed glioblastoma multiforme (GBM) based on magnetic resonance imaging~     (MRI) or biopsy, including administration before surgery and during adjuvant~     chemoradiotherapy. Patients will be treated with 3 days of preoperative DSF/copper (Cu) prior~     to their surgery (or biopsy), which will be followed by collection of blood and tumor samples~     during surgery for analysis of drug uptake. After the surgery, patients will receive standard~     radiation therapy (RT) and temozolomide (TMZ) with the addition of concurrent DSF/Cu.~   "
65043|NCT02715596|"~     Evaluates the effect of EPA supplementation in terms of muscle mass in patients with squamous~     cell carcinoma of the head and neck locally advanced~   "
65044|NCT02715583|"~     Patients with castrate resistant prostate cancer (CRPCA) with osseous metastatic disease~     planning to undergo Ra-223 therapy may be eligible for this study. Positron emission~     tomography (PET/CT) imaging will use the investigational radiotracer [11C]acetate. Imaging~     will occur prior to Ra-223 therapy and after 2 cycles, in addition to standard of care~     99mTcMDP bone scan at baseline and a research 99mTc-MDP bone scan post-therapy~   "
65045|NCT02715570|"~     PC945 is a new medicine being developed for treatment of fungal lung diseases. The main~     purpose of this study is to investigate the safety, tolerability and pharmacokinetics of~     single and repeat doses of PC945~   "
65046|NCT02715557|"~     In Phase I of this SBIR project, 3C Institute (3C) developed a working prototype of an~     innovative computer-based coping skills educational program for adolescent substance abuse~     treatment completers. For Phase I, 3C developed and tested two customizable intelligent~     educational modules to teach coping skills in order to help adolescents avoid relapse, along~     with a brief instructional game for each segment. The Phase I prototype also included an~     online Parent Guide to inform parents about the uses and benefits of the product. Phase I R&D~     provided strong support for the quality and value of the prototype as well as the viability~     of the proposed educational package and its promise for preventing substance abuse relapse~     with adolescents. Phase I results supported excellent quality of the product through high~     ratings of quality, appeal, and value. High feasibility and usability was also demonstrated~     through high ratings for ease of use, usability, and potential effectiveness.~      The goal of this Phase II SBIR project is to modify and expand the relapse prevention program~     developed in Phase I in response to customer feedback and to evaluate the efficacy of the~     full program with an RCT pilot clinical study. This product will be an adaptable software~     program for aftercare therapy. In Phase II, the investigators will build on the Phase I~     findings to modify and extend the existing content and develop the full program, which will~     include: an introductory module as well as interactive lessons and skill-building games for~     five coping skills modules. The Phase II product will also include a HelpCenter to support~     sustained, quality use of the product during commercialization.~   "
65067|NCT02715284|"~     This is a multicenter, open-label, first-in-human Phase 1 study evaluating the~     anti-programmed death receptor 1 (anti-PD-1) antibody TSR-042 in patients with advanced solid~     tumors who have limited available treatment options. The study will be conducted in 2 parts:~     dose escalation and cohort expansion. The cohort expansion may include various tumor types,~     including endometrial, Non-Small Cell Lung cancer, and MSI-H solid tumors.~   "
65068|NCT02715271|"~     The correlation of the morphologic, microbiological, genetic and histopathological~     characteristics of TB lesions obtained in therapeutical surgery with the clinical forms and~     features of the patients will provide essential information~        1. on the role of the host in the mechanisms associated to the generation and evolution of~          active TB and~        2. about future diagnostic and/or prognostic biomarkers of TB disease. All this information~          could be used for patients stratification and/or to design new therapeutic strategies.~   "
65047|NCT02715544|"~     Recent research suggests a majority of Hong Kong's toddlers (aged 2 to 4) are much less~     active than is recommended and are increasingly engaged in sedentary behaviour, which places~     them at risk of becoming overweight or obese. The proposed project will test whether~     connecting families to nature positively influences physical activity (that is, active~     playtime) and healthy eating routines in children aged 2 to 4. The investigators have~     recently conducted a pilot study Play & Grow (P&G), a programme based on the most successful~     international preschool interventions described in the literature. In addition to adopting~     healthy eating and physical activity intervention elements, the programme was enhanced by~     including a novel third element: connectedness to nature (CN). To test the effectiveness of~     this enhanced intervention, the plan is to run a family-based randomised controlled trial~     (RCT). The intervention will include 240 families with children aged 2 to 4, will take the~     form of one-hour activity sessions for parents and children held once a week for 10 weeks.~     The investigators will assess lifestyle-related habits before, immediately after the~     completion the intervention, at 6 months and one year after the intervention. Created for~     this purpose, a novel measuring tool for connectedness to nature, Nature Relatedness Scale~     (NRS), will be validated and tested for reliability prior to the RTC. The results of RCT are~     intended to be used to understand which components of the intervention were most effective.~     The objectives of this project will be achieved over a 36-month period, and it is expected to~     contribute to a close examination of key components of successful healthy lifestyle promotion~     programme during early childhood. The investigators predict that is that the new element CN~     will significantly improve the intervention. Finally, the overall aim is that connecting~     families to nature will result in sustainable lifestyle changes that remain with them for a~     lifetime.~   "
65048|NCT02715531|"~     This study will evaluate the safety, efficacy, and pharmacokinetics of atezolizumab in~     combination with bevacizumab, bevacizumab + oxaliplatin, leucovorin and 5-fluorouracil (5-FU)~     (FOLFOX), vanucizumab, nab-paclitaxel + gemcitabine, FOLFOX, or 5-FU + cisplatin, in~     participants with solid tumors.~   "
65049|NCT02715518|"~     The aim of the study is to compare clinical outcomes following fractional flow reserve~     (FFR)-guided versus angiography only guided strategy in treatment of non-infarction related~     artery (non-IRA) stenosis in patients with acute myocardial infarction (AMI) with multivessel~     disease~      Prospective, open-label, randomized, multicenter trial to test the clinical outcomes~     following FFR-guided or angiography-guided strategy in treatment of non-IRA stenosis in~     patients with acute AMI with multivessel disease.~   "
65050|NCT02715505|"~     This study is designed to assess the safety and exploratory efficacy of using HSC835 in~     patients with Inherited Metabolic Disorders (IMD) undergoing stem cell transplantation.~   "
65051|NCT02715492|"~     Hepatocellular carcinoma (HCC) is a major health problem worldwide, and most cases are~     inoperable because of late presentation and underlying cirrhosis. It represents the fifth~     most common tumor in the world and the third most frequent cause of mortality amongst~     patients with cancer.~      Due to the worldwide difficulties in finding liver for transplantation, hepatic resection~     (HR) represents the main stay of curative treatment for patients with HCC. Transcatheter~     arterial chemoembolization (TACE) is widely used as alternative treatments for unresectable~     HCC or for patients not eligible to be operated on .~      TACE also could be an adjuvant therapy for resectable HCC patients after hepatectomy, which~     could prevent recurrence and improve long-term survival .~   "
65052|NCT02715479|"~     The purpose of this study is to evaluate how BMS955176 affects pharmacokinetics (PK) of~     Dolutegravir (DTG) and also how DTG administration affects the PK of BMS955176~   "
65053|NCT02715466|"~     This prospective, double-blind randomized controlled trial evaluates the differences in terms~     of efficacy and safety of gelatin based resuscitation as compared to crystalloid based~     resuscitation in two parallel groups of patients with severe sepsis / septic shock.~   "
65054|NCT02715453|"~     Frailty has been associated to a worse outcome in acute coronary syndromes, but the best~     management of frail patients after an acute coronary syndrome remains unknown. The aim was to~     investigate the benefit of an intervention on frailty in frail patients after an acute~     myocardial infarction.~      Patients survivors after an acute myocardial infarction (with and without ST-segment~     elevation), older than 70 years and with pre-frailty (1-2 points) or frailty (≥3 points)~     according to the Fried's scale measured 24 hours before hospital discharge, will be included.~     The participants will be randomized to 2 strategies: a) intervention on frailty in addition~     to the usual care by the cardiologist, and b) conventional strategy consisting only of the~     usual care by the cardiologist. A multidisciplinary team (physicians, nurses and~     physiotherapists and nutritionists) will carry out the intervention on frailty The study~     contemplates a 2-year inclusion period and a 3rd year for the follow-up of the last included~     patient. The main outcome will be the frailty status (Fried's scale) at 3 months and 1 year.~     The secondary endpoint will be the clinical events, both cardiovascular and not~     cardiovascular events, including recurrent events (cumulative events analysis), for the total~     follow up (3 years in the case of the first included patient). The hypothesis is that an~     intervention on frailty will improve frailty status and the clinical outcomes in frail~     patients after an acute myocardial infarction.~   "
65055|NCT02715440|"~     Intervention randomized controlled open study with 2 parallel arms . The objective of this~     study is to evaluate the feasibility of stopping the benzodiazepines treatment in elderly~     living in nursing homes.~      It will check that the judgment of these molecules has no pejorative effect on sleep or~     behavior of residents and does not induce withdrawal syndrome. Two patient groups will be~     constituted. One will begin a gradual withdrawal of benzodiazepines in six weeks. The other~     group will continue his treatment and withdrawal will be proposed after 8 weeks by his~     general practitioner (delayed intervention).~      Effects on sleep will be assessed by wrist actimetry for 10 weeks and a sleep diary . The~     repercussions of withdrawal on behavior will be rated by the NPI scale.~   "
65056|NCT02715427|"~     Enhanced rehabilitation programs are based on new therapies and treatment combinations to~     reduce the length of hospitalization, duration of postoperative convalescence, morbidity, but~     also the overall cost of care. The operating stress and hypercatabolic conditions surrounding~     the surgery are sources of complications. In this enhanced rehabilitation approach, the~     principle is to fight through a series of actions against this surgical stress. Several North~     American studies, Chinese, Scandinavian or Batavian have shown the feasibility and the~     interest of enhanced perioperative rehabilitation in liver surgery. Nevertheless, there is~     not until now French data concerning the assessment of enhanced rehabilitation in liver~     surgery. The main objective of the study is to compare the effectiveness of the~     implementation of a multimodal management program after liver surgery in a French university~     center compared to conventional care. Secondary objectives of the study are to compare an~     enhanced rehabilitation program in liver surgery versus conventional treatment in terms of~     morbidity and mortality in the immediate postoperative period and until day 90, length of~     hospital stay, blood loss and the delay to bowel mobility recovery. Compliance to the program~     in both groups will also be evaluated.~   "
65057|NCT02715414|"~     A multiple family group (MFG) is a family-centered, group delivered, evidence-informed,~     manualized intervention that targets the most common reason for referral to publicly funded~     clinics: youth oppositional defiant and conduct disorders. This study will employ a mixed~     methods Type II effectiveness-implementation hybrid research design.In collaboration with the~     New York State Office of Mental Health (OMH), this longitudinal study will be conducted~     across the New York City (NYC) OMH licensed child behavioral health clinic system (n=134).~     The investigators will use mixed methods, and involve 268 providers and 2,688 adult~     caregivers of youth (7 to 11 years).~      The following Specific Aims guide this study: To examine 1) short-term and longitudinal~     impact of MFGs on urban youth with Oppositional Defiant Disorder (ODD) and Conduct Disorder~     (CD) (replication); 2) family-level mediators (e.g. parenting, family process) of child~     outcomes; 3) clinic (readiness to adopt an innovation, leadership support and climate) and~     provider level moderators (preparedness, motivation and fidelity) of MFG implementation and~     integration and; 4) the impact of Clinic Implementation Teams (CIT) on clinic and provider~     level moderators of MFG implementation and integration. In this Randomized Controlled Trial,~     clinics will be stratified by borough (Manhattan, Queens, Bronx, Brooklyn, Staten Island) and~     randomly assigned within borough to 3 study conditions: 1) MFG+CITs; 2) MFG (with standard~     research training and consultation) or; 3) Standard Care. Data will be collected baseline, 8~     and 16 weeks and 6 mo. follow-up) in Phase 1 (focus on implementation) and Phase II~     (integration).~   "
65058|NCT02715401|"~     To investigate the pharmacokinetic properties and safety after administration of HCP1303 and~     co-administration of HGP1201, HIP1402 under Fed Condition in healthy male volunteers~   "
65059|NCT02715388|"~     Evaluate the use of Elbit's digital electro-optical systems for generating detailed high~     quality video imaging during surgery, and thus improving the surgeon's visualization,~     performance and outcome.~   "
65060|NCT02715375|"~     This is a pivotal, 12-month, randomized, sham controlled, parallel group, multicenter, double~     blind study with an allocation ratio of 1:1. The study population is children between the~     ages 6 to 17 years, with mild to moderate persistent asthma. The purpose of the study is to~     determine whether the CREON2000A, an environmental control device, will decrease asthma~     severity, as measured by the Composite Asthma Severity Index (CASI), in children with mild to~     moderate persistent allergic asthma over a twelve month period.~   "
65061|NCT02715362|"~     Intravenous infusion of CART cells in the treatment of solid tumors may be not a suitable~     choice. Because by intravenous infusion, T cells first entered into the blood circulation,~     but the number of T cells accumulated at the tumor site is limited, while the probability is~     high that CART cells contact with normal tissue where target protein is expressed, leading to~     a more potential off-target side effect. In this study, CART cells infused to the body is~     mediated by the method of transcatheter arterial infusion(TAI), which is one kind of tumor~     intervention therapy pathway. We hope by this means could improve the local CAR-T cell~     numbers，meanwhile reduce the potential side effects.~   "
65062|NCT02715349|"~     Families with a patient with schizophrenia and the patient are randomly assigned to receive~     either a 3 session psychoeducation program, or no psychoeducation. Other treatment for~     schizophrenia and other mental illness are provided as usual.~   "
65063|NCT02715336|"~     Individuals undergoing In Vitro Fertilization must undergo controlled ovarian~     hyperstimulation (COH) to produce enough quality eggs for fertility treatment. Ovarian~     follicular responsiveness to COH with gonadotropins is extremely variable between patients~     and even from cycle to cycle for the same patient. Achieving an ideal follicular response is~     critical to the success of assisted reproduction treatment (ART). Patients have been~     classified as 'poor', 'normal' or 'high' responders, which dictate the amount of~     gonadotropins that they receive. It is still important to develop treatments with high~     efficacy, lower multiple birth rates, and a lower complication rate for each of these groups.~     In an era of evidence-based medicine and with special emphasis on reducing IVF risks (mainly~     OHSS and pregnancies with multiples), it is very important to find optimal and safe ovulation~     induction and triggering regimens for each patient population.~      The use of GnRH agonist (GnRHa) triggering among high responders in order to reduce or~     eliminate OHSS is an example of an important breakthrough in the clinical management of IVF~     patients. Although GnRHa triggering was shown to be as effective as human chorionic~     gonadotropin (hCG) at inducing oocyte maturation more than 20 years ago, its use to trigger~     ovulation was not possible until the introduction of GnRH antagonists for pituitary~     suppression.~      Another prominent trend in ART in recent years has been the introduction of dual triggering,~     which involves a combination of GnRHa plus hCG for triggering. This regimen creates~     simultaneous lutenizing hormone (LH) and follicle stimulating hormone (FSH) surges by the~     GnRHa, which resembles physiologic ovulation triggering, together with sustained LH-like~     activity from the hCG, which stimulates the corpus luteum to excrete sufficient hormonal~     endometrial support. Since its introduction, dual triggering has been gaining popularity due~     to outstanding results in retrospective studies among both normal and high responders.~     Moreover, in spite of the encouraging retrospective reports, prospective randomized~     controlled trials (RCT) on dual triggering have not been reported to date. The aim of the~     current proposed study is to compare the efficacy of dual triggering and conventional~     triggering among the three IVF populations (high, normal and poor responders).~   "
65064|NCT02715323|"~     Ocular surface disease, especially dry eye and scleritis, commonly affects patients with~     autoimmune diseases. Ocular surface immune cells are increased in autoimmune disease; however~     the full subset of immune cells activated is unknown. Recent experimental studies show that~     dendritic cells and T cells in the cornea are critically associated with corneal nerve~     innervation. Corneal confocal microscopy (CCM) allows rapid non-invasive in vivo imaging of~     dendritic cells and corneal nerves. The investigators propose to investigate how ocular~     surface health, conjunctival immune cells and corneal nerve/dendritic cell morphology~     interact in 3 rheumatological conditions: Sjogren's syndrome (SS), Rheumatoid arthritis (RA),~     Systemic lupus erythematosus (SLE).~      The preliminary flow cytometric studies show that various immune cells (eg: T cells, B cells,~     and dendritic cells) can be quantified using minimally invasive impression membranes~     (Eyeprim). Clinically, the research team is experienced in measuring features of ocular~     surface inflammation (conjunctival redness, tear breakup times) with Oculus keratograph5M.~     The investigators also aim to harvest conjunctival immune cells using impression cytology and~     quantify specific cell types with flow cytometry. Corneal nerve morphology and dendritic cell~     density and distribution will be assessed using CCM; in collaboration with the group who have~     pioneered this technique.~      The investigator anticipate that alterations in corneal nerve and dendritic cell parameters~     will correlate with immune activation/inflammation, deterioration of tear function and~     increased systemic severity of the rheumatological disease. In addition, the investigators~     hypothesize that the lower the corneal nerve density, the higher the number of corneal~     dendritic cells and conjunctival inflammatory cells. Studying these relationships may allow a~     better mechanistic understanding of local corneal and systemic immune activation and the~     development of a non-invasive ophthalmic surrogate marker of dendritic cell activation and~     nerve fibre loss to aid earlier diagnosis, risk stratification and the development of new~     therapies in autoimmune patients with severe dry eye.~   "
65065|NCT02715310|"~     In order to estimate the effect of fluid management in regard to postoperative complications~     this observatory study will document every kind of fluid intervention peri- and~     intraoperatively.~   "
65069|NCT02715258|"~     The purpose of this study is to investigate the effect of bexagliflozin in lowering~     hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM).~   "
70649|NCT02642224|"~     Primary outcome: Research participants and their network contacts will be followed over 6~     months to assess whether a social work case management protocol results in reduction of~     trauma services recidivism and criminal violence arrests.~   "
65070|NCT02715245|"~     In this research, investigators pretent to evaluate the effectiveness of clinical,~     functional, psychological and social impact of an intervention model based on shared care~     between the Mobile Rehabilitation and Physical therapy team (MRPTT) and nurse case managers~     of Primary Care in a sample of patients with multiple chronic diseases (comorbidities) and~     their caregivers. A non-randomised controlled trial.~   "
65071|NCT02715232|"~     The aim of this study is to prove the modulatory influence of sex hormones on serotonergic~     neurotransmission by determining the enzymatic processes involved in serotonin synthesis and~     degradation using positron emission tomography (PET) in humans in vivo with the radiotracers~     [11C]AMT and [11C]harmine.~   "
65072|NCT02715219|"~     Asthma is an important chronic disease that causes a significant public health problem and~     the commonest medical conditions treated in health clinics giving rise to considerable~     morbidity and mortality. Several studies suggested that improvement of patient knowledge has~     become a key component of asthma management. In the study setting the education material for~     Asthma patient is available however the proper cannel to deliver it to patient remains a~     puzzle to the researcher, therefore this study is trying to close the gap between Asthma~     education material and patient.The aim of the study is to investigate the effectiveness of an~     Asthma Education Program (AEP) result in improvement of patient's knowledge, medication~     adherence and inhaler technique.This is an experimental study a clinical trials. Data will be~     gathered utilising three an adapted instrument to assess patient knowledge of their disease,~     medication adherence and inhaler technique. Patients who are came to Asthma Bay in Emergency~     Department, Respiratory Clinic for routine follow up and admitted to ward will be recruited~     as study subjects. Subject who are agree to enrol in the study will be randomized into~     intervention and control group. Subjects in intervention group will be undergone one session~     of an AEP, however there are no intervention for control group but continue routinely follow~     up in Respiratory Clinic. To obtain the study result descriptive and inferential statistical~     analysis will be performed. To analyse the statistical significant of the change in patients'~     health outcome the pre and post of AEP independent t-test or chi-square test will be used.The~     expected finding of this study is to determine the effectiveness of AEP result in of~     patients' knowledge regarding asthma disease, medication adherence and inhaler technique, pre~     and post of AEP.~      Keywords: asthma, asthma education program.~   "
65073|NCT02715206|"~     The purpose of this study is to determine if a new substance use prevention curriculum for~     rural middle schools is effective in reducing substance use and to study how prevention~     curriculum get implemented by teachers.~   "
65074|NCT02715193|"~     This is a randomized, placebo-controlled, double-blind study to evaluate safety, tolerability~     and pharmacodynamics of REMD-477 in subjects who have Type 1 diabetes and are currently~     receiving insulin treatment. This proof of concept study will determine whether glucagon~     receptor blockade using a single dose REMD-477 can improve short-term glucose homeostasis in~     people with Type 1 diabetes.~   "
65075|NCT02715180|"~     The almost evidences of the optimal hand position during compression had been based on chest~     computed tomography (CT) or chest plain films of patients for investigating the effective~     location for compressing the left ventricle of the heart during cardiopulmonary resuscitation~     (CPR).~      However every study was conducted at full inspired state of respiration. A prospective cohort~     study to evaluate the proper hand position during CPR based on expired respiratory state CT~     as the health screening would be needed.~   "
65076|NCT02715167|"~     The hypothesis is that a high fractional exhaled nitric oxide can predict the response to~     inhaled corticoids in chronic cough.~   "
65077|NCT02715154|"~     Current cesarean section often chooses spinal anesthesia. And in order to avoid the impact of~     drugs on the fetus, before the delivery, anesthesiologist generally don't use sedative or~     analgesic drugs. However, the majority of puerperas would appear nervous, anxiety, fear and~     other psychological reactions in cesarean section. Although the placental transfer and the~     foetal metabolism of dexmedetomidine have been reported and the result show no adverse~     effects on neonates, but the placental transfer of dexmedetomidine in intravertebral~     anesthesia area was lack of systematical research. This study intends to use of~     dexmedetomidine in the cesarean section under epidural anesthesia and investigate its effects~     on the parturients' haemodynamics and the neonates' placental transfer and metabolism.~   "
65078|NCT02715141|"~     Rationale: Since January 2014 the Dutch screening programme for bowel cancer has been~     implemented. Screening will increase the demand for surveillance. Although patients in whom~     adenomas have been removed are at increased risk of progressing to cancer, solid evidence on~     the reduction of death from CRC through the current colonoscopy-based surveillance is~     lacking. Furthermore, colonoscopy-based surveillance leads to high logistic demands, high~     individual burden and high costs. Therefore, there is need for new surveillance strategies.~     Stool-based molecular testing (Cologuard®, consisting of a stool DNA test and an~     immunochemical assay for human hemoglobin) or Faecal Immunochemical Testing (FIT) may serve~     as an alternative for colonoscopy surveillance.~      The aim of this study is to compare the accuracy of an established molecular stool test~     (Cologuard®) and FIT to colonoscopy for detection of advanced adenomas or CRC (advanced~     neoplasia) in a surveillance population. These outcomes will be used to model various~     strategies of stool-based molecular surveillance to inform health policy decisions.~   "
65079|NCT02715128|"~     Major depressive disorder (MDD) is a common, recurrent, and frequent chronic disorder. Among~     others, deficient cognitive control over emotional distraction is a central characteristic of~     MDD (Ochsner & Gross 2005; Disner et al. 2011; Beck 2008). Hypoactivation of the dorsolateral~     prefrontal cortex (DLPFC) has been linked with this deficit (Dolcos & McCarthy 2006).~     Moreover, aberrant functional connectivity patterns have been found in MDD patients (Kaiser~     et al. 2015). Transcranial direct current stimulation (tDCS) is a non-invasive brain~     stimulation method that has been largely investigated in experimental neurosciences and tDCS~     of the prefrontal cortex (PFC) has been proposed as novel treatment in MDD. So far,~     prefrontal tDCS has been shown to enhance cognitive control over emotional distraction in MDD~     patients (Wokenstein & Plewnia 2013). Also, tDCS-induced connectivity changes found in fMRI~     studies comparing resting-state networks configurations before and after prefrontal tDCS may~     reflect a state of enhanced alertness (Keeser, Meindl, et al., 2011; Park et al., 2013).~      The aim of this study is to investigate the neurophysiological correlates of tDCS effects in~     MDD patients. For this purpose, functional magnetic resonance imaging (fMRI) data is~     collected during the execution of a cognitive control task as well as during a resting-state~     condition following real or sham tDCS. It is hypothesized that prefrontal tDCS as compared to~     sham a) reduces distractibility by compensating for deficient DLPFC activity and b) enhances~     functional connectivity in networks associated with externally directed attention or~     cognitive engagement.~      In this placebo-controlled study patients with a diagnosis of MDD receive a single treatment~     with prefrontal tDCS (anode over electrode position F3, cathode over F4, 20 min, 2mA~     intensity) or sham tDCS (frequency and duration correspondent active tDCS, ramp in and ramp~     out periods only without intermittent stimulation). Before, during, and after the treatment~     resting-state measurements in the fMRI scanner are conducted. Subsequently, participants~     perform the cognitive control task (in dependence of Plewnia, C., Schroeder, P. A., &~     Wolkenstein, L. (2015)) in the scanner. The patients are assigned to either the real or sham~     tDCS condition according to a randomised, double-blind parallel design.~   "
65080|NCT02715115|"~     The purpose of this study is to determine whether NNZ-2566 is safe and well tolerated in the~     treatment of Rett syndrome in children and adolescents.~   "
65094|NCT02714933|"~     The aim of this study is to compare a new Magnetic Resonance Imaging (MRI)protocol, including~     a new MRI sequence for visualization of lung parenchyma, to computed tomography as the gold~     standard for the evaluation of thoracic region in children.~   "
65081|NCT02715102|"~     Patients who are about to undergo a diagnostic or therapeutic bronchoscopy or thoracic~     surgery without a distant history of cancer will have their blood drawn for measurement of~     circulating tumor DNA (ctDNA) to validate the utility of molecular diagnostic assays for the~     early detection of lung cancer.~   "
65082|NCT02715089|"~     The purpose of this study is to explore the precise treatment in hepatobiliary cancer~     patients and evaluate drug safety, progression free and overall survival. This trial study is~     based on genetic tests, then therapeutic target drugs are administered according to the~     genetic test reports. Patients with genetic abnormalities (such as mutations, amplifications,~     or translocations) may benefit from precise treatment which targets particular genetic~     abnormality. The identifications of these genetic abnormalities may help treat hepatobiliary~     cancer patients better.~   "
65083|NCT02715076|"~     The purpose of this study is to determine:~        1. the effect of ambient temperature on the rate of core temperature change from 1 to 3~          hours after induction of anesthesia (linear phase of the hypothermia curve) in major~          operations lasting at least a couple of hours and~        2. whether the relationship between ambient temperature and rate of core temperature change~          is different for patients who are or are not warmed with forced-air.~   "
65084|NCT02715063|"~     Several studies have shown relationship between exercise intensity and improvement~     cardiometabolic health such as body composition, endothelial function, blood pressure and~     blood lipids. It has been suggested that high intensity interval training and also strength~     or resistance training generate positive effects on metabolic risk factors, nevertheless the~     comparison between both types of training and their combination has not yet provided~     conclusive evidence. Also, it has been shown that dietary restriction has similar or more~     positive effects that exercise alone and the effect is greater when it is combined with~     exercise. For these reasons, it is necessary to clarify which type of training, in~     combination with a dietary restriction, is more effective to improve cardiometabolic health~   "
65085|NCT02715050|"~     The effects of phototherapy has been widely studied by some research groups. The~     investigators know that there are positive results with light application to improve muscle~     performance and delay fatigue. However, there are few studies showing its´ effects on~     muscular training. Therefore, the aim of this study was to assess the effects of phototherapy~     applied at different times during 12 weeks of strength training. For such, 48 volunteers,~     healthy male, from 18 to 35 years old were recruited to perform a strength training protocol~     for the anterior muscle of the thigh development. Volunteers performed the training protocol~     three times a week for 12 weeks. There were assessed isometric peak torque in isokinetic~     dynamometer, concentric peak torque, 1-repetition maximum test in the leg extension and leg~     press machines and bilateral thigh perimetry.~   "
65086|NCT02715037|"~     Prospective, observational study of the microbiology of patients referred to a tertiary care~     center with severe acute tonsillitis, peritonsillar cellulitis, or infectious mononucleosis.~   "
65087|NCT02715024|"~     The objective of this study is to evaluate the clinical efficacy and safety of tamsulosin~     alone or in combination with solifenacin for the treatment in men with lower urinary tract~     symptoms (LUTS) including overactive bladder (OAB) symptoms in Taiwan.~   "
65088|NCT02715011|"~     The purpose of this study is to characterize the safety and tolerability of JNJ-63709178 and~     identify the recommended Phase 2 dose(s) (RP2D) and schedule for JNJ-63709178 in Part 1 and~     to characterize the safety and tolerability of JNJ-63709178 at the RP2D(s) in Part 2.~   "
65089|NCT02714998|"~     The investigators aimed to investigate the effects of salpingectomy and Methotrexate~     administration on ovarian reserve in ectopic pregnancy.~   "
65090|NCT02714985|"~     Retrospective laboratory evaluation of the detection rate of CHIKV infection by real-time~     Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) on urine. Urine and serum samples~     from patients with confirmed CHIKV infections from an endemic area (Aruba) and from ITM will~     be analyzed. The results will be evaluated on a case-by-case basis: time since onset, patient~     characteristics, severity of symptoms, serology results.~      The positivity in-time of CHIKV RNA in urine will be evaluated in comparison with viremia.~     Patients with suspected acute CHIKV infection will be asked (by written informed consent;~     annex 1) to provide urine samples within 72 hours after onset of disease, followed by urine~     samples on day 7, day 10, day 14 and three urine samples 3, 4 and 12 weeks after onset. They~     will be asked to provide serum samples within 72 hours after onset of disease, followed by~     serum samples on day 7, day 10, day 14. In total, twenty patients with an initial positive~     result of CHIKV RT-PCR on serum will be included for follow-up. The number of urine samples~     that will be tested is 140.~   "
65091|NCT02714972|"~     Objective: to gain experience in children and younger adolescents with in-home use of an~     algorithm that will dose insulin to minimize projected hyperglycemia overnight in addition to~     suspending the pump if hypoglycemia is projected overnight and to obtain feasibility, safety,~     and initial efficacy data~      Study Design: randomized controlled trial, with randomization on a night level within subject~     Patient Population: Youth 6.0 - <15 years old with type 1 diabetes treated with daily insulin~     therapy for at least one year and an insulin infusion pump for at least 6 months who have~     HbA1c < 10.0%.~      Sample Size: 30 subjects~      Study Duration and Visit Schedule: duration approximately 3 months, with preliminary run-in~     activities followed by up to 90 days spent in clinical trial phase of study; clinic visits at~     enrollment, following CGM and system assessment run-in phases, at start of clinical trial~     phase, at 21-day point of clinical trial phase, and after 42 nights of successful system use~      Major Efficacy Outcomes:~        -  Primary: time in range (70-180 mg/dl, 3.9-10.0 mmol/L) overnight.~        -  Secondary: time spent in hypoglycemia (<70 mg/dl, 3.9 mmol/L) and time spent in~          hyperglycemia (>180 mg/dl, 10.0 mmol/L) overnight.~      Major Safety Outcomes: CGM measures of hypo- and hyperglycemia, including morning blood~     glucose and mean overnight sensor glucose; adverse events including severe hypoglycemia and~     diabetic ketoacidosis~   "
65092|NCT02714959|"~     The purpose of this study is to determine whether low-dose IL-2 is effective in refractory~     autoimmune encephalitis.~   "
65093|NCT02714946|"~     The purpose of this study is to prospectively compare percutaneous radiofrequency ablation~     (RFA) versus percutaneous laser ablation (LA) for the treatment of solid thyroid nodules.~   "
79422|NCT02527369|"~     This study was designed to demonstrate safety and efficacy of the XP1100RF for non-invasive~     temporary reduction of thighs circumference by disruption of adipocyte cells.~   "
65095|NCT02714920|"~     Squamous cell carcinoma (HNSCC) is the most frequent form of head and neck cancer. The~     therapeutic choice depends on the stage of the disease and the habits of the medical teams.~     Surgery, radiotherapy and chemotherapy can be used, alone or combined. However, none of the~     existing strategies has proven its superiority.~      Chemotherapy and radiotherapy induce DNA damages in the tumor cells. However, cells have the~     ability to induce DNA reparation, capable of causing treatment resistance. DNA reparation in~     non-tumor tissues can also explain the toxicity of cancer treatments.~      Investigation of DNA repair pathways involved in chemo- or radiation resistance could offer a~     good strategy for identifying biomarkers or indicators of treatment response. This study will~     explore the capacity of a comprehensive functional approach that addresses several pathways,~     based on the use of three innovative patented technologies, to classify the tumor response of~     HNSCC patients to treatments according to their DNA Repair Enzyme Signature.~      Our hypothesis is that taking into account various clinical parameters (e.g. patient and~     tumor characteristics), treatment strategy and measuring the DNA Repair Enzyme Signature~     would create patients' profiles and optimize their management.~   "
65096|NCT02714907|"~     The purpose of this study is to validate the quality of the ECG-signal acquired with the~     Cortrium C3 monitor. The intention is to evaluate whether the diagnosis of atrial~     fibrillation based on the ECG signal from the C3 monitor concurs with the current monitoring~     methods used in clinical practice.~   "
65097|NCT02714894|"~     The purpose of this study is to investigate the relationship between glutamate and related~     brain chemicals and treatment response to clozapine in patients with treatment-resistant~     schizophrenia.~   "
65098|NCT02714881|"~     The objective of this study is to elucidate the relationship between inflammation and~     lipoprotein atherogenicity, and to determine the relative contribution of inflammation and~     lipids to CV risk in RA. The central hypothesis of this study is that inflammation and~     lipoprotein atherogenicity is tightly linked such that both factors are important to assess~     CV risk in RA. Further, the investigators hypothesize that this relationship is obscured by a~     consideration of routine lipids alone.~   "
65099|NCT02714868|"~     The purpose of this study is to determine the extent to which Project TEAM (Teens making~     Environment and Activity Modifications) is an effective, socially valid, and feasible~     intervention that prepares youth with developmental disabilities ages 14-21 to respond to~     environmental barriers and increases participation in school, work, and the community.~     Project TEAM is a manualized intervention co- facilitated by a disability advocate and a~     licensed professional. The intervention includes eight group sessions and two experiential~     learning field trips. In addition, young adults with disabilities serve as peer mentors on~     field trips and contact youth weekly to support attainment of goals. Project TEAM outcomes~     are to: increase youths' knowledge of environmental factors and modification strategies;~     reduce the impact of environmental barriers on participation; increase self-efficacy and~     self-determination; and increase participation in a personal activity goal in the area of~     education, employment, or community life. This project builds on a participatory action~     research partnership with disability community stakeholders to address the following research~     questions: (1) To what extent do youth with disabilities participating in Project TEAM~     achieve intervention outcomes? (2) What are the characteristics of youth with disabilities~     who most benefit from Project TEAM? (3) To what extent are goals, procedures, and outcomes of~     Project TEAM important and acceptable (socially valid) to youth with disabilities?.~   "
65100|NCT02714855|"~     The present study will be conducted to assess the following research questions in real-life~     conditions in France:~      What are the patient and disease characteristics, comorbidities and treatment history in NVAF~     patients initiating a new Anticoagulant (AC) treatment, according to treatment currently~     available and prescribed (apixaban, other NOACs, VKAs), and are the AC-naive patient profiles~     different from one treatment pattern to another when initiating a new AC treatment?~      What are the HCP's reasons for discontinuing the previous AC strategy for initiating and~     choosing the newly initiated AC treatment in NVAF patients?~      What are the conditions of newly-initiated apixaban prescriptions in NVAF patients:~     prescriber, proportion of naïve/experienced patients, daily dosage and number of daily doses?~   "
65101|NCT02714842|"~     This is a single-centre, open-label, randomised, three-arm crossover study with a fourth~     fixed arm in a subset of subjects. Up to 36 healthy male volunteers will participate in the~     study. This study is designed to correlate the gastrointestinal transit behaviour of~     delayed-release diclofenac sodium tablets with their pharmacokinetic (PK) absorption~     profiles.~      The investigators will be looking at:~        1. The behaviour of the tablets (when, where and how quickly they break up)~        2. The gastric emptying time of the tablets (when they leave the stomach)~        3. The gastrointestinal transit of the tablets (how long they take to travel through the~          gut)~        4. Blood levels of the drug (diclofenac)~   "
65102|NCT02714829|"~     This is a prospective, outcomes assessor-blinded, randomized study to evaluate the efficacy~     and safety of Inject BMP(Injectable Ceramics Bone Graft Substitute Containing rhBMP-2) for~     socket preservation after extraction of a single-rooted tooth, compared to~     ExcelOS-inject(Injectable Ceramics Bone Graft Substitute).~   "
65103|NCT02714816|"~     MGT005 is a natural history study to collect longitudinal prospective data from patients with~     Leber Congenital Amaurosis associated with defects in RPE65.~   "
65104|NCT02714803|"~     The aim of this study is to compare of different massage techniques plus conservative~     aplications in low back pain treatment.~   "
65105|NCT02714790|"~     Study purpose is to assess the prognostic role of Minimal Residual Disease (defined as~     medullary expression of WT1 gene), performed at Baseline and during treatment according to~     clinical practice. MRD results will be relate to treatment outcome and survival analysis~     variables (Overall Survival, Disease Free Survival, Cumulative Incidence of Relapse)~   "
65106|NCT02714777|"~     The objective of the ANESPEDIA study is to describe in a pediatric population (aged from 4 to~     8 years old) receiving elective surgery, the impact of general anesthesia on autonomic~     nervous system and their kinetics of early postoperative course (24 hours).~   "
65107|NCT02714764|"~     The purpose of this study is to define the natural history of Alexander Disease, a~     leukodystrophy that causes neurological dysfunction. Investigators will obtain clinical~     outcome assessments to measure how the disease affects a patient's gross motor, fine motor,~     speech and language function, swallowing, and quality of life. The data obtained from this~     study will be used for the design of future treatment trials.~   "
65108|NCT02714751|"~     Mechanical ventilation (MV) if a life-support treatment for critically ill patients that can~     develop adverse effects. Patient-ventilator asynchronies can be present from the beginning of~     MV, it can be associated with poor outcome and it can develop clinical changes. The aim of~     this study is to evaluate if the knowledge of the presence of asynchronies by the healthcare~     team can help to reduce its incidence, improving outcomes of critically ill patients.~      A prospective, single-center, before and after study will be conducted in the ICU of Hospital~     de Sabadell. The study will have 2 phases: a first observational period where the incidence~     of asynchronies will be assessed, and a second period where a daily information of the~     presence of asynchronies to the healthcare team will be done with the aim to reduce the~     incidence.~      A continous record of asynchronies and clinical variables will be done during ICU stay.~   "
65109|NCT02714738|"~     The purpose of this study is to determine whether the incidence of tourniquet pain is~     decreased if infraclavicular nerve block is administered, compared to axillary brachial~     plexus block, for surgical interventions at the level or distal to the elbow.~   "
65110|NCT02714725|"~     This study is designed to explore the possible effects of dexmedetomidine infusion on~     sublingual microcirculation in patients undergoing on-pump coronary artery bypass graft~     surgery~   "
65111|NCT02714712|"~     The scavenger receptor type B class I (SR-BI) is a receptor for high-density lipoproteins~     (HDL) and one of entry factors for hepatitis C virus (HCV). The investigators aimed to~     examine the association of single nucleotide polymorphisms (SNPs) of the SCARB1 gene, which~     encodes SR-BI, with virologic responses to pegylated interferon-based treatment in Asian~     chronic hepatitis C (CHC) patients.~   "
65112|NCT02714699|"~     The study aims to determine the efficacy of oral hyoscine butyl bromide versus diclofenac~     potassium on the pain scores during office hysteroscopy~   "
65113|NCT02714686|"~     In this experiment, the investigators will study the effect of a mass media family planning~     campaign on contraception related behavior. The study takes place in Burkina Faso, a country~     with an average of six children born to each woman, and a modern contraceptive prevalence~     rate (mCPR) estimated at 15% in 2010 at the national level, as per the Demographic Health~     Survey (DHS) 2010 report on Burkina Faso.~      The aim of this study is to provide robust evidence on the efficiency and cost-effectiveness~     of an intense three-year mass media campaign focused on family planning. The campaign will~     diffuse messages about the financial and health benefits of family planning, and information~     on the different types, sources, advantages, and disadvantages of different contraceptive~     methods. The study will target women at the age of reproduction in rural areas of Burkina~     Faso to measure the effect of the intervention on total and modern contraceptive prevalence~     rates, perceptions of family planning, contraception-related behavior, and general gender~     norms.~      Burkina Faso is an ideal place to evaluate the impact of a radio campaign because a high~     percentage of the rural population listens to local radio which is in the local language.~     Radio station areas are distinct because they target very local languages and their reach is~     limited by government decree, which allows for the implementation of a randomized control~     trial.~   "
65114|NCT02714673|"~     It is a multicenter, prospective, observational study of standard care. This study analyses~     the care of patients on long term effective anticoagulation therapy (ADELC) during a primary~     hip or knee arthroplasty.~      The objectives of the study are to:~        1. Identify clinical practices set up for patient care~        2. Assess the type and the frequency of perioperative complications~        3. Look for factors, related to patients or treatments, associated with the occurrence of~          these complications.~      The main objective is to estimate the risks, adjusted and not, of postoperative complications~     associated to a long term anticoagulation by comparing patients under anticoagulation to a~     control group of patients having the same interventions but who are not under~     anticoagulation.~   "
65115|NCT02714660|"~     This mixed methods study aims to answer the question: What is the work of being a patient~     with type 2 diabetes mellitus? .~   "
65116|NCT02714647|"~     The purpose of this study is to determine if priming attention prior to practicing a motor~     task will have an effect on the ability to acquire and learn that motor task. The~     investigators hypothesize that the acquisition and learning of a motor task will improve if~     attention is primed prior to practicing that motor task when compared to a group who does not~     receive the prime.~   "
65117|NCT02714634|"~     Approximately, 40 to 50% of patients with rheumatoid arthritis (RA), the most frequent~     inflammatory arthritide, are non responders to the consensual 1st line of treatment :~     methotrexate. In these patients, it is well demonstrated that the addition of other~     immunomodulatory drug(s) often results in a significant improvement. However, the best option~     regarding the drug(s) to add remains unclear. Rheumatologists are currently used to adding a~     targeted biologic therapy, such as anti-TNFα, and more recently abatacept or tocilizumab.~     Triple therapy using 3 conventional disease-modifying drugs (DMARDs),~     methotrexate+salazopyrine+hydroxychloroquine could be an alternative option to biologics, all~     the more as they have a more favorable safety profile and a much lower cost. Uncertainty~     remains regarding the superiority of biologics on triple therapy in methotrexate insufficient~     responders (IR). Investigators decided to address this issue by performing a randomized~     controlled pragmatic trial.~   "
65118|NCT02714621|"~     The primary objective of this pilot study is to determine whether or not it is feasible to~     use MRgHIFU to treat symptomatic (pain, bleeding) recurrent pelvic malignancy with an~     acceptable safety profile when conventional treatment options are not available. The ultimate~     goal is to be able not only to offer a viable method of symptom palliation in patients with~     recurrent pelvic tumours and improve their quality of life; but also to control tumour growth~     and extend life in a group of relatively young patients with isolated local recurrence.~   "
65119|NCT02714608|"~     Ginsenoside H dripping pills is a kind of traditional Chinese medicine(TCM), This study is~     being conducted to evaluate the efficacy and safety of ginsenoside H dripping pills in~     patients with advanced (stage ⅢB/Ⅳ) Non-small Cell Lung Cancer (Syndrome Of Qi-Deficiency)~     and explore the optimal dosage~   "
65120|NCT02714595|"~     This study is designed to provide evidence of efficacy of S-649266 in the treatment of~     serious infections in adult patients caused by carbapenem-resistant Gram-negative pathogens.~   "
79423|NCT02527356|"~     The three purposes of this study are: 1) to examine the feasibility and effects of ride-on~     car training with two different postures on mobility and socialization in toddlers with~     disabilities; 2) to quantify whether toddlers with disabilities are able to have more~     exploratory behaviors and social interactions with ride-on car training through observation~     and wrist-worn accelerators; 3) to determine the critical factors of using the different~     modes of modified ride-on toy car on family perceptions and participation. Independent~     mobility is believed to be essential for perceptual-motor, cognition, language and social~     skill development. It is important to increase independent mobility in toddlers with~     disabilities and further enhance their development, especially socialization. Assertive and~     power mobility devices allow toddlers with disabilities to move independently within their~     environment and may increase the opportunities to explore environment and interact with~     people. However, issues to consider before prescribing an assertive device include factors~     such as age, accessibly to community environments, cost, and social acceptance of the device~     and the adaptability of the device to growth. To address these limitations and meet toddlers'~     needs, the concept of using modified ride-on toy cars (ROC) in therapy becomes a novel~     application. Studies have demonstrated the use of toy cars enhanced a child's motivation,~     socialization and family participation. Investigator preliminary results of the group study~     showed significantly increased mobility, socialization and decreased parenting stress level~     after the toy car training in toddlers with disabilities.~      More percentages of participants in the treatment group had clinical meaningful improvements~     on mobility and social function than the control group. Evidence supported that specificity~     of psychological changes associated with different modes of locomotion, particularly the loco~     motor experience involving motor activity, e.g., postural control; the perceptual information~     (e.g., periphery optical flow) and action experience affect psychological development.~      Therefore, this study is further to examine the effects of ride-on toy car training with two~     different postures, i.e., sitting and standing , on independent mobility, exploration and~     socialization through low-cost, family-centered approach. It will also improve family's~     understanding of children's capabilities, which improves their development. Based on the~     power analysis from the preliminary results of investigator group study, investigators will~     recruit 60 children with disabilities who are between 1 to 3 years old and diagnosed as motor~     delay (>1.5 sd). They will be randomly assigned to one of the following three groups: ROC-Sit~     group, ROC-Stand group and regular therapy group. The whole study duration will be 24 weeks,~     including 12-week intervention and 12-week follow-up; the total amount of treatment will be~     equal for three groups. Standardized assessments are provided for a total of three times~     during the study, including the time before and after the intervention and in the end of the~     follow-up phase. The ROC-Sit and ROC-Stand programs will be administered by the therapist and~     include 120 minutes/per session, 2 sessions/per week. The research team will visit the~     hospital once/per week to provide 60 minutes videotaping and let participants wear wrist-worn~     accelerators. The regular therapy group will continue their regular therapy without any~     additional car driving training. The research team will visit them once/per week for the~     assessments. The assessments include standardized measurements and behavioral coding from the~     videotapes and accelerators.~      The findings of this study will provide a novel therapeutic tool (i.e., combining the~     low-tech modified ride-on cars with different postures) on advancing children's mobility,~     socialization, family participation and development.~   "
65121|NCT02714582|"~     Hospitals face the challenge to continually improve their quality of care. In order to~     achieve this goal, they have to focus on both improving clinical practice and increasing the~     involvement of patients in the healthcare process. Both factors are equally important to~     quality of care. The World Health Organization highlights the role that patients and their~     family could play in the improvement of healthcare. Active patient participation reduces~     communication errors, increases patient empowerment and is associated with positive health~     and psychosocial outcomes. A possible strategy to improve patient participation through~     communication can be bedside shift report (BSR).~      Bedside shift report is a process where shift-to-shift report between nurses is, if approved~     by the patient, executed at the patient's bedside in order to improve the patient's~     involvement. Bedside shift report has the potential to result in more patient satisfaction,~     better clinical outcomes, improvement of health education and enhanced team coherence.~     Preliminary research indicates that BSR decreases safety incidents and adverse events and~     readmissions, positively influences staff satisfaction, offers beneficial financial effects~     by reducing nurses' overtime, and allows direct patient care to start earlier.~      Despite of these effects, rigorous and large-scale scientific research on this topic is~     lacking. Currently, the available evidence is scarce and mostly consists of single case or~     small-scale studies. Longitudinal results on effectiveness and sustainability of BSR are also~     unknown or inconclusive. There is a need for an increased number of controlled studies to~     evaluate the impact of BSR on patient, staff and economic outcomes and its longitudinal~     results.~      The aim of this study is four-folded:~        1. The development and fine-tuning of a BSR-intervention and implementation protocol by~          using diagnostic interviews, co-design, and pilot studies.~        2. A quantitative evaluation of BSR in comparison with care as usual on patient-related,~          clinical, and nurse-related outcomes.~        3. A qualitative evaluation of the feasibility, appropriateness and meaningfulness of BSR~          as a method to improve communication and patient participation with a particular~          interest in the experience of benefits and disadvantages by healthcare professionals and~          patients.~        4. A process evaluation of BSR to determine the intervention fidelity and to assess the~          evolution of BSR over the period of the study (e.g. adaptations, consistent practice).~      The study design was based on the Medical Research Council-framework for developing and~     evaluating complex interventions. Power calculation indicates a minimum of 5 experimental~     wards with 35 patients should be included in the study. The hospital, the specialization of~     the ward and the nurse-patient ratio will be used for the matched controlled assignment.~   "
65122|NCT02714569|"~     The purpose of this two-part study is to evaluate the safety and tolerability of the study~     drug known as LY3202328 in healthy overweight participants in Part A, and those with~     dyslipidemia (abnormal blood fats) in Part B.~   "
65123|NCT02714556|"~     Pregnancy is associated with physiological changes affecting the cardiorespiratory system as~     a consequence of an increase in both cardiac output and intra-abdominal pressure. The aim of~     this prospective observational study is to examine the perioperative changes in ventilation~     inhomogeneity and respiratory function measured by the non-invasive nitrogen multiple breath~     washout and forced oscillation techniques.~   "
65124|NCT02714543|"~     Oral submucous fibrosis is a chronic, insidious disease caused by arecanut use and is~     associated with both significant morbidity (including burning sensation and reduced oral~     opening) and an increased risk of malignancy. Treatment of Oral SubMucous Fibrosis has~     largely been symptomatic and is associated with high recurrence rate. Aloevera has~     immunomodulatory, anti-inflammatory, wound healing, antioxidant and antineoplastic~     activities. All such properties of Aloevera suggest the possibility of its use in the~     management of oral submucous fibrosis.~      In the present study, 74 patients of Oral SubMucous Fibrosis were randomly divided into 2~     groups (Group A & B). Group A patients were instructed to drink 30ml of aloe vera juice twice~     daily before food and to apply 5mg (approx 1 scoop) of aloe vera gel over the lesion 3-4~     times daily for 3 months. Group B patients were given intralesional injections of 1.5ml~     Hydrocortisone acetate 25mg/ml and hyaluronidase (1500 IU) weekly for 6 weeks. They were also~     prescribed SM Fibro (Alpha lipoic acid 50mg, Beta-carotene 10mg, Elemental copper 1mg,~     Elemental selenium 75mcg, Lycopene 5mg, Vitamin E 10 IU, Zinc sulphate 27.45mg in form of the~     capsule) for 3 months. Patients were assessed for burning sensation, interincisal~     mouthopening, cheek flexibility and tongue protrusion at an interval of 1, 2 and 3 months.~   "
65125|NCT02714530|"~     The purpose of this study is to determine if erlotinib given orally along with concurrent~     palliative irradiation to lung cancer improves local control compared to those treated with~     radiotherapy alone.~   "
65126|NCT02714517|"~     The purpose of the study is to evaluate the efficacy of hydrotherapy on pain and balance in~     patients affected by neuropathy.~   "
65127|NCT02714504|"~     Patients admitted for autologous or allogeneic hematopoietic cell transplantation,~     induction-remission chemotherapy for acute myeloid leukemia, myelodysplasia or acute lymphoid~     leukemia, or to receive immunosuppressive therapy for aplastic anemia will be screened with~     dermatologic examination. In the presence of any skin lesion in the extremities, direct exam~     and fungal culture will be performed. If these exams indicate the presence of Fusarium~     species, patients will receive anti-mold azole prophylaxis~   "
65128|NCT02714491|"~     Aim of the study is to define if the auditory stimulation during stepping verticalization~     sessions with Erigo is able to modify the cerebral electric activity or improve~     consciousness in patients affected by vegetative state or minimally conscious state.~   "
65129|NCT02714478|"~     The purpose of the study is to evaluate the effect of Equistasi device on quantitative and~     qualitative gait characteristics in patients affected by hemiparesis.~   "
65130|NCT02714465|"~     Evaluation of clinical improvement and the reduction of edema lesion documented by magnetic~     resonance imaging (MRI) in patients with cerebral radiation necrosis post gamma knife surgery~     (GKS) by treatment with hyperbaric oxygen therapy (HBO)~   "
65131|NCT02714452|"~     The overall aim of this study is to evaluate the effects, meaning and significance of a~     person-centred and thriving promoting model for residential aged care in Australia, Norway~     and Sweden. More specifically, the following research questions will be explored:~        1. Can a person-centred and thriving promoting care model increase residents' thriving, and~          have a positive impact on residents' perception of the caring environment?~        2. Can a person-centred and thriving promoting care model increase relatives' satisfaction~          with care, and have a positive impact on their experience of visiting their relative,~          and perception of the caring environment?~        3. Can a person-centred and thriving promoting care model increase staff's job~          satisfaction, decrease stress of conscience, and have a positive impact on their~          perception of the caring environment and person-centred care?~        4. What meaning and significance do relatives and staff ascribe to the intervention? The~          study is designed as a multi-centre, controlled group before-after design with~          participating sites in Victoria (Australia), Oslo (Norway) and Västerbotten (Sweden).~          Two residential aged care facilities at each site will be allocated to either~          intervention or control, in total three intervention and three control facilities~          divided over the three sites.~      Care staff at the intervention facilities will participate in a 12-month education on how to~     integrate aspects of person-centredness, thriving and a caring environment into daily care~     practice. Participating staff will work together with their colleagues and members from the~     research group to create a reflective and creative learning environment that builds on and~     develops the staff members' clinical experience and skills, and combines it with theoretical~     and research-based knowledge.~      At the control facilities, care staff will participate in a 2-hour lecture on the theoretical~     and philosophical foundations of person-centredness, thriving and a caring environment, and~     then continue with practice without further involvement from the research team.~      Evaluation data will be collected by study specific questionnaires before the education~     starts, immediately after the education and at a 6-month follow-up. In addition, focus group~     interviews and individual interviews will be conducted with a selection of staff members and~     relatives at the intervention facilities to explore meaning and significance of the~     intervention.~   "
65156|NCT02714127|"~     The aim of the study is to develop robust analytical protocols for first-void urine sample~     preparation and biomarker assays to analyze a panel of biomarkers in first-void urine for~     improved diagnosis of cervical (pre)cancer lesions.~   "
65132|NCT02714439|"~     The purpose of this study is to evaluate a different type of medical equipment called~     High-Resolution Microendoscope (HRME) for the diagnosis of cervical pre-cancerous lesions~     and cervical cancer. The investigators want to compare patients' clinical findings using the~     current equipment used in clinic with the clinical findings using new equipment we are~     testing on this research project. If the new equipment is proven to give comparable findings~     with current equipment being used, doctors might be able to offer a diagnosis and treat~     cervical lesions in one visit. It might not be necessary to wait for cervical biopsies to~     come back before women would receive the indicated treatment. Study subjects are being asked~     to participate because they have been diagnosed with an abnormal Papanicolaou (Pap) PAP~     smear, positive human papillomavirus (HPV) test or history of cervical dysplasia and need to~     have a colposcopic examination to determine the reason for abnormal results and receive~     treatment.~   "
65133|NCT02714426|"~     Attentional control, or individuals' ability to choose which stimuli in the environment they~     attend to and which they ignore, declines with older age. Studies from the past two decades~     suggest that mindfulness meditative practice, such as a standardized mindfulness based stress~     reduction programs, may increase the efficiency of attention networks.To date, the majority~     of studies that have related mindfulness meditation practice to attentional control have been~     based on retrospective self-reported mindfulness or cross-sectional measurement in~     experienced meditators. More recent experimental studies using pre-post training designs have~     shown that meditation-naïve individuals can experience attentional improvement with~     mindfulness intervention. This study seeks to elucidate the time course and process by which~     such attentional improvements might be achieved.~      This research study investigates change in attentional control as participants progress~     through an 8-week mindfulness-inspired training (MIT) intervention, and has two specific~     aims: 1) to determine the time course of change in attentional components such as cognitive~     control and sustained attention as a consequence of MIT; attention will be measured weekly~     for 3 weeks before, 3 weeks after, and during 8 weeks of MIT. 2) To investigate the extent to~     which change in attentional performance is coupled/correlated with markers of emotion~     regulation, perceived mindfulness, and perceived mind wandering.~   "
65134|NCT02714413|"~     Individuals in the United States now consume a substantial proportion of their total energy~     as added sugars. The consumption of caloric sweeteners has been steadily increasing over the~     last four decades. The potential health consequences of this practice have been subject to~     considerable debate. In addition to weight gain, higher consumption of sugar-sweetened~     beverages is associated with development of metabolic syndrome and type 2 diabetes. These~     findings support the current dietary guidelines that encourage consumers to limit their~     intake of added sugars. There is a need for a sugar substitute that is safe, palatable and~     has favorable effects on energy metabolism and overall glucose homeostasis. One such sugar is~     possibly D-allulose also referred to in the literature as D-psicose. The present proposal is~     to address the efficacy of D-allulose in reducing postprandial blood glucose level in a~     random sample of Caucasian and African American population. Specifically the effect of~     D-allulose ingestion on the glucose and insulin response to a standardized oral glucose load~     will be studied.~   "
65135|NCT02714400|"~     The investigators hypothesis is that obstructive sleep apnea (OSA) patients with a low~     arousal threshold may wake up too early during a respiratory event, before upper airway~     muscles can be activated to achieve stable ventilation. Thus, strategies to manipulate the~     respiratory arousal threshold could potentially improve the quality of sleep and sleep~     disordered breathing. Agents that raise arousal threshold are therefore likely to benefit~     some patients with OSA. The overall goal of this project is to determine the importance of~     the arousal threshold in OSA, determine which patients might benefit from a raised arousal~     threshold, and test this hypothesis by using pharmacological manipulation of the arousal~     threshold to achieve this goal.~   "
65136|NCT02714387|"~     The purpose of this observational epidemiological study is to investigate the management and~     the complications associated with Non Traumatic Neuro-Vascular Diseases. Data will be~     analysed to answer pre-defined scientific projects and to improve management of these~     conditions.~   "
65137|NCT02714374|"~     The purpose of this study is to evaluate the safety of the investigational product GL-ONC1.~     GL-ONC1, a vaccinia virus, has been genetically modified for use as a potential anti-cancer~     drug to destroy cancer cells. Vaccinia virus has been used successfully in the past as~     smallpox vaccine in millions of people worldwide.~   "
65138|NCT02714361|"~     Iron is one of the most vital elements in humans as it plays a role in physiological~     functions such as transferring and storing oxygen, transporting electrons and catalysing~     numerous reactions, from oxidative metabolism to cellular proliferation. Iron deficiency can~     be attributed to poor absorption that leads to insufficient iron to meet body requirements.~     Oral iron supplements have been extensively used to treat iron deficiency and iron deficiency~     anaemia. However, the use of iron compounds in fortifying foods is one of the best practical~     approach to combat iron deficiency, while improving diet and food pattern involves long-term~     goal which can be challenging. Vitamin D has recently been shown to affect hepcidin levels,~     which in turn has effects on iron status but there are a limited number of studies~     investigating the hepcidin profile in humans following iron supplementation, and few data are~     available, especially in humans, despite its role as a primary iron absorption and~     homeostasis regulator. Although several studies have been carried out using iron fortified~     products, there is limited data on the potential effect of vitamin D on iron metabolism~     amongst iron deficient women in particular. Therefore, the present study aims to investigate~     the effect of vitamin D3 supplementation (1500 IU) consumed with iron fortified breakfast~     cereals on haematological indicators and hepcidin response in iron deficient women.~   "
65139|NCT02714348|"~     Helminth infection is associated with low vaccine immunogenicity. Pregnant women are~     particularly sensitive to helminth infection.~      Since most vaccines are given shortly after birth, an effect of parasites on infant~     immunogenicity is of particular concern. Therefore, within this study the investigators aim~     to investigate if maternal infection influences vaccine immunogenicity in the newborn.~   "
65157|NCT02714114|"~     The aim of the study is to develop robust analytical protocols for first-void urine sample~     preparation and antibody assays to monitor natural and/or vaccine induced immunity against~     HPV (Human Papillomavirus).~   "
65140|NCT02714335|"~     Considering the low expression rate of Melanoma-associated antigen 3 (MAGE-A3) in Asian~     especially Southeast Asian, it would be great interests to investigate the potential~     polymorphism of MAGE-A3 in Non-Small-Cell Lung Cancer (NSCLC) patients in Taiwan. Meanwhile,~     it is also interesting to study the expression of Preferentially Expressed Antigen In~     Melanoma(PRAME) and Epidermal growth factor receptor (EGFR) mutation status as well as to~     find out significant factors which may affect their expression such as smoking status,~     histological types, tumour size and stages in Taiwan.~   "
65141|NCT02714322|"~     To assess the equivalence of MYL-1401A to Humira® with regards to efficacy in subjects with~     moderate-to-severe chronic plaque psoriasis~   "
65142|NCT02714309|"~     Consuming whey protein may have beneficial effects on health, principally by having an impact~     on blood glucose metabolism, but also by affecting appetite. The purpose of this project is~     to investigate the effect of consuming whey protein preload prior to breakfast, following a~     bout of low/moderate intensity exercise (brisk walking), on glucose and lipids in the blood~     as well as on appetite.~      It is hypothesised that the consumption of whey protein before a meal after prior~     low/moderate intensity exercise may positively affect postprandial handling as well as~     appetite sensations and consequently reduce intake at a subsequent meal.~   "
65143|NCT02714296|"~     This study is an open, prospective, comparative diagnostic studies aimed at improving the~     colonoscopy results, by optimizing the way of preparation for endoscopy~   "
65144|NCT02714283|"~     The purpose of this study is to provide patients and their physicians with greater~     understanding of the risks and benefits of commonly used therapies for treatment of non-CF~     bronchiectasis~   "
65145|NCT02714270|"~     Paperless partograph is a technique used for monitoring the progress of labor before~     delivery, and arriving at the accurate time to intervene for ensuring a safe delivery.~      The study will be carried out to find out the effectiveness of paperless partograph in~     management of labor and its effect on maternal and neonatal outcomes~   "
65146|NCT02714257|"~     The investigators propose a 36-month multi-center randomized effectiveness trial to compare~     the impact of an Enhanced Usual Care (Control) intervention, with Exercise Coaching~     (Exercise), on Fragility Fractures and Serious Fall-Related Injuries (FF/SFRI) in patients~     with a previous fragility fracture (FF).~      The investigators will also examine the impact of the intervention on several secondary~     outcomes like: loneliness, physical function, and bone strength. The investigators will do~     this by following a Pragmatic trial design: 1) limiting exclusions to increase~     representativeness, 2) limiting research contacts (average 30 min/year) and 3) limiting~     measures to those practicable for use in usual care.~   "
65147|NCT02714244|"~     Diastolic function may be evaluated by different measurements on transesophageal~     echocardiography (TEE). They include mitral inflow velocities obtained by pulsed-wave doppler~     (PW) : peak early diastolic velocity (E) and late diastolic velocity (A). Mitral annulus~     velocities, early diastolic (e') and late diastolic (a') are obtained by tissue doppler~     imaging (TDI). The ratio E/e' reflects left ventricular filling pressure and, as such, might~     be a predictor of fluid responsiveness.~      The aim of this study is to evaluate the predictive value of the mitral valve E/e' ratio for~     fluid responsiveness among patients undergoing coronary bypass graft surgery. Fluid~     responsiveness being defined as an increase in stroke volume of ≥ 15%.~      After induction of anesthesia, patients will have their diastolic function evaluated by means~     of E/e' and other measures. They will then be administered an intravenous bolus of 500 mL of~     Lactate Ringer® along with passive leg raising (PLR). Stroke volume and fluid responsiveness~     will be assessed by the thermodilution method (Swan-Ganz catheter) and the FloTrac® device.~     Fluid responders will be compared to non-responders to evaluate the relationship between E/e'~     ratio and fluid responsiveness.~   "
65148|NCT02714231|"~     The aim of our study is to compare the analgesic effect of oral diclofenac sodium versus oral~     hyoscine butyl bromide during intrauterine device insertion.~   "
65149|NCT02714218|"~     The purpose of this study is to evaluate two different dose combinations of nivolumab and~     ipilimumab in the treatment of melanoma.~   "
65150|NCT02714205|"~     A randomized, double-blinded, placebo-controlled trial of uninterrupted transdermal nitrate~     therapy in 140 peri- or postmenopausal women who have frequent hot flashes. Women will be~     randomly assigned to uninterrupted use of transdermal nitrate therapy (participant directed~     dose-escalation of 0.2 to 0.6 mg/hr) or identical-appearing placebo patches for 12 weeks.~   "
65151|NCT02714192|"~     The purpose of the study was to determine if administration of an exercise stress test within~     the first ten days after a sports related concussion would delay or otherwise interfere with~     recovery.~   "
65152|NCT02714179|"~     The investigators designed a prospective randomized study to investigate the efficacy of~     intravenous (IV) preemptive versus preventive paracetamol on postoperative pain scores,~     patient satisfaction, total morphine consumption and the incidence of morphine‑related side~     effects in patients undergoing cesarean section.~   "
65153|NCT02714166|"~     To evaluate the human eye irritation potential of one test sunscreen formulation.~   "
65154|NCT02714153|"~     To evaluate the use of an occlusion balloon (Bridge™ Occlusion Balloon, Spectranetics) within~     the Superior Vena Cava in lead extraction patients.~   "
65155|NCT02714140|"~     Despite worldwide efforts to promote HIV Counseling and Testing (HCT), rates of testing~     remain low. Understanding how high risk groups decide to test and adapting available testing~     options to their preferences has the potential to broadly improve HCT uptake and~     cost-effectiveness. This study proposes to use a Discrete Choice Experiment, a survey method~     increasingly used by health economists for the design of patient-centered health care~     options, to rigorously quantify HIV testing preferences among two high-risk populations,~     identify their preferred testing options, and evaluate, in a pragmatic randomized controlled~     trial (RCT), the effect of a preference-based HIV counseling and testing (PB-HCT)~     intervention on testing uptake. At a time of heightened focus on health preferences research~     and patient-centered care, this study evaluates the critical link between preference-based~     intervention design and efficacy. If the RCT indicates that PB-HCT increases testing rates,~     the testing options evaluated in this R01 can be offered to high-risk populations in the~     study area, and the preference elicitation method and tools can be used to inform the design~     of testing options that better match the preferences of other high-risk populations and in~     other settings.~   "
65158|NCT02714101|"~     Children with Autism Spectrum Disorder have difficulty engaging in activities. This study~     examined the effects of equine-assisted occupational therapy for 7 children with ASD ages 4~     to 8 years. A multiple baseline design was used. For each child, there were 9 to 11 baseline~     assessments, 9 to 12 intervention sessions, and 4 follow-up sessions.~   "
65159|NCT02714088|"~     High-intensity interval training (HIT) has been demonstrated to be an effective strategy to~     improve markers of health and fitness across a wide range of healthy and clinical~     populations. Currently however, there is only limited evidence which has examined the~     effectiveness of HIT in older adults (>50 years). HIT is an appealing strategy in this group~     as it has the potential to impact both cardiorespiratory and muscular fitness, which both~     play an important role in maintaining functional fitness and quality of life in a~     time-efficient manner. Developing an understanding of novel strategies for delivering this~     type of exercise training may ultimately provide a viable alternative to traditional modes of~     exercise training for a broader range of participants. As such, the purpose of this study is~     to evaluate the effects of a novel, high-intensity interval training exercise protocol to~     improve physical fitness in adults aged over 50 years. This research also aims to evaluate if~     this type of training intervention is feasible in this population, through analysis of~     adherence and intervention fidelity.~   "
65160|NCT02714075|"~     Rice can only be fortified with ferric pyrophosphate (FePP), which is of low bioavailability~     in human subjects. Compounds such as citric acid/trisodium citrate (CA/TSC) or sodium~     ethylene-diamine tetraacetic-acid (EDTA) could serve as absorption enhancers. Recent findings~     from single meal studies indicate CA/TSC to have an enhancing effect on iron absorption from~     FePP-fortified rice. In contrast, ZnO has been suggested to have detrimental effects.~     Furthermore, in vitro findings suggest an increased iron solubility from iron and~     EDTA-co-fortified rice - but the bioavailability in humans remains to be investigated. These~     effects should thus be investigated in 'real-life' conditions, when fortified rice is~     implemented in a complete diet administered throughout several days in a target population~     for a rice fortification program.~      Objective: To assess iron absorption from the diet from different iron fortified rice~     formulations in iron deficient anaemic children.~      The investigators aim to conduct an iron absorption study in 30 Ghanaian school-age children~     investigating different fortification approaches in a multiple meal randomized, cross over~     study.~   "
65161|NCT02714062|"~     The primary objective of this study is to describe the pharmacokinetic profiles of VI-0521 in~     obese adolescents.~   "
65162|NCT02714049|"~     Unblinded study of flibanserin for 8 weeks with responders randomized 1:1 to receive study~     medication alone vs. study medication and sex therapy for 12 additional weeks.~   "
65163|NCT02714036|"~     This is a multi-center, open-label study of MN-166 (ibudilast) in subjects with ALS. To be~     eligible subjects must meet the El Escorial criteria of possible, laboratory-supported~     probable, probable, or definite criteria for a diagnosis of ALS. Safety, tolerability, blood,~     neuro-imaging biomarkers, and clinical outcomes will be collected on all subjects. Subjects~     will receive study drug for 36 weeks.~      The study will consist of a Screening Phase (up to 6 weeks), an Open-Label Treatment Phase~     (36 weeks) and a Off-Treatment Follow-up Phase (4 Weeks).~      Number of Subjects (Planned):~      Approximately 45 subjects are planned to be screened with the goal of enrolling 35 subjects.~   "
65164|NCT02714023|"~     Patients who are diagnosed with acute appendicitis consented and then randomized into two~     arms of the trial. In one arm, patients receive irrigation of the abdomen during surgery with~     normal saline, or salt water. In the other arm, patients receive irrigation of the abdomen~     during surgery with sterile water. Sometimes patients receive no irrigation if none is~     determined to be needed at the time of operation by the surgeon. We then followed patients~     after surgery for 30 days. The hypothesis of this study was that the use of sterile water as~     irrigation fluid during surgery in patients who have acute appendicitis will decrease the~     chance of a post-operative abscess or infection.~   "
65165|NCT02714010|"~     This is a multi-center phase III randomized controlled study, designing to access whether the~     efficacy of EGFR-TKI alone on patients with brain metastasis from non-small cell lung cancer~     (NSCLC) harboring EGFR mutant type is not inferior to EGFR-TKI concurrent with whole brain~     radiotherapy (WBRT), the primary end point is intracranial PFS (iPFS), while secondary~     outcomes included overall survival (OS), objective response rate (ORR), evaluation of~     cognitive function, quality of life (QoL) and adverse events.~   "
65166|NCT02713997|"~     Patients with severe chronic pancreatitis may be candidates to have their pancreas removed~     and their islets transplanted into the liver to reduce the risk of diabetes mellitus, a~     procedure called total pancreatectomy with islet autotransplant (TPIAT). However, over half~     of patients who have a TPIAT will need to remain on some supplemental insulin life-long after~     the procedure. We will study therapies that may reduce damage to transplanted islets, and~     thereby improve long-term outcomes.~      Two promising anti-inflammatory therapies are available to protect islets from damage at the~     time of transplant: (1) the Tumor Necrosis Factor (TNF)-alpha inhibitor etanercept and (2)~     the serine protease inhibitor alpha-1 antitrypsin. Both agents are commercially available for~     clinical trials. Proof-of-principle for etanercept has been demonstrated in type 1 diabetic~     allotransplant recipients, in whom a 10 day course of etanercept early post-transplant~     significantly improved long-term insulin independence, due to better survival of the~     transplanted beta cell mass in the engraftment period. Alpha-1 antitrypsin (A1AT) reduces~     inflammatory cytokines, protects against cytokine-induced beta cell apoptosis, and prolongs~     islet graft survival in mice and intraportal IAT non-human primates.~      This initial 3-arm drug-treatment clinical trial will investigate the use of Etanercept and~     A1AT to improve IAT function at 90 days and 1 and 2 years post-TPIAT compared to standard~     care. Forty-five patients undergoing TPIAT will be randomized 1:1:1 to receive either: 1)~     etanercept (50 mg on day 0; 25 mg on days 3, 7, 10, 14, and 21), 2) alpha-1 antitrypsin (90~     mg/kg IV days -1, +3, 7, 14, 21, 28) or 3) standard care. Patients will have mechanistic~     assessments drawn in the early post-operative period including inflammatory cytokines and~     chemokines and measures of beta cell loss. Metabolic testing will occur at 90, 365, and 730~     days post-TPIAT, including mixed meal tolerance testing, IV glucose tolerance testing, and~     glucose-potentiated arginine-induced insulin secretion (GPAIS).~   "
65167|NCT02713984|"~     Chimeric antigen receptor T cells (CAR-T) therapy has not yet been fully explored in solid~     tumors. Human epidermal growth factor receptor-2(HER2) is widely expressed in cancers.~     Investigators have developed anti-HER2 CAR-modified T cells and validated the efficiency~     targeting HER2-positive cancer in preclinical studies. This study is aimed to confirm its~     adverse effects including cytokine storm response and any other adverse effects. In addition,~     CAR-T cells persistence, tumor elimination and disease status after treatment will be~     evaluated.~   "
65181|NCT02713802|"~     Evaluate pharmacokinetic/pharmacodynamic equivalence and safety and tolerability of single~     doses of Cudafol(R) and Diprivan(R) in healthy subjects.~   "
65168|NCT02713971|"~     Background: In this study, a new biofeedback system for balance and gait rehabilitation~     (Gamepad) was developed. The system, based on wearable inertial sensors, provides users with~     real-time visual and acoustic feedback about their movement during functional tasks. Gamepad~     was applied on subjects with Parkinson's disease (PD) in a pilot randomized controlled trial~     to investigate its feasibility and efficacy versus conventional physiotherapy. The~     investigators hypothesized that Gamepad system can be easily applied in clinical settings and~     that biofeedback training with Gamepad provides larger improvements of balance and gait in PD~     subjects, respect to conventional physiotherapy.~      Methods: Forty-two PD patients underwent a 20-session training for balance and gait (45~     minutes per session, 3 sessions per week). Participants were randomized into Gamepad Group~     (biofeedback rehabilitation with Gamepad system), and Control Group (conventional~     physiotherapy). Clinical and instrumental assessments were performed by a blind examiner~     pre-, post-intervention and at 1-month follow-up.~   "
65169|NCT02713958|"~     This experimental research aims to examine the efficacy of Telerehabilitation treatment using~     a computerized system (MediTouch) in improving the upper limb function post elbow fractures.~     24 participants aged 18-80 who are post surgery to fixate elbow fractures or arthrolysis of~     the elbow will be invited to participate in the study. The subjects will be matched into two~     groups according to age and fracture type to study and control groups. Both groups will be~     treated for a month in ambulatory clinic in the hospital and will do self-practice at home~     according to a intervention protocol. The subjects in the experimental group will receive two~     treatments in Telerehabilitation and one treatment in the clinic weekly, and the subjects in~     the control group will receive three treatments in the clinic every week. Activity daily~     living (ADL), Range of Motion, Hand strength disability and pain will be assessed before and~     after the intervention in order to asse the efficacy of the intervention.~   "
65170|NCT02713945|"~     This study evaluate the efficacy of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-COA) reductase~     inhibitors, also known as statins in the treatment of growth and skeletal abnormalities in~     children with Noonan syndrome. Half of patients will receive simvastatin while the other half~     will receive a placebo.~   "
65171|NCT02713932|"~     The Italian Society of Invasive Cardiology Registry on Percutaneous Aortic Valve is a~     prospective Italian registry including several centers performing TAVI, collecting baseline,~     procedural and outcome data.~   "
65172|NCT02713919|"~     Background: Up to 64% of cancer patients experience pain, and as many as 40% of patients with~     pain do not receive adequate pain management. And while potential to reduce pain has been~     shown in several interventions that support patients' self-management, effects have been~     moderate. Purpose: This multicenter mixed methods study primarily aims to evaluate the~     efficacy of the adapted German PRO-SELF© Plus Pain Control Program (PCP) on pain intensity,~     to explore the intervention's effect on associated symptoms and other patient and family~     caregiver (FC) outcomes, and to explore patients' and FCs' experiences with cancer pain~     management.~      Methods: A nested concurrent mixed methods design will be used for this multi-center study,~     that is, a randomized controlled trial (RCT) will be combined with a qualitative substudy.~     Participants will be randomly assigned to a 6-week intervention or usual care group; outcomes~     will be evaluated at 6 weeks post-randomization. The primary outcome will be pain intensity.~     A total sample of 210 patients with cancer pain and approximately 105 FCs will be recruited~     from the oncology outpatient clinics of the University Hospitals Basel, Zurich and Bern. The~     intervention is designed to implement structured and tailored components (information,~     skill-building, nurse coaching) and aims at improving patients' pain self-management. Data~     analysis will follow an intent-to-treat strategy and generalized mixed models will be used.~     For the qualitative substudy, 60 patients and FCs of both groups will be interviewed. Data~     will be systematically summarized.~   "
65173|NCT02713906|"~     The purpose of this study is to assess the positioning of customized guides designed from~     patients X-Rays (Materialise X-Ray Knee Guides) using computed tomography in primary total~     knee arthroplasty.~   "
65174|NCT02713893|"~     The primary objective of the study is to evaluate local tolerability of the new~     Econazole/Benzydamine product, in comparison with the Econazole and Benzydamine stand-alone~     products and placebo. Pharmacokinetics of the study products after single and repeated~     applications once a day for 15 days, safety of the investigational products and comfort of~     use will also be evaluated as secondary objectives.~   "
65175|NCT02713880|"~     Development of a new MS-based biomarker for the early and sensitive diagnosis of~     Transthyretin-Related Familial Amyloidotic Polyneuropathy from plasma. Testing for clinical~     robustness, specificity and long-term stability of the biomarker.~   "
65176|NCT02713867|"~     The primary objective of this study is to show that PFS (progress-free survival) rate at 6~     months and at 1 year after randomization, of Nivolumab 480 mg every 4 weeks is non-inferior~     to nivolumab 240 mg every 2 weeks in subjects with advanced/metastatic (Stage IIIb/IV) NSCLC~     (non-Sq and Sq).~   "
65177|NCT02713854|"~     To determine the predictive value of attachment rate of human embryonic stem cells~     (hESC)-derived trophoblast spheroids (BAP-EB, embryo surrogate) onto endometrial epithelial~     cells (EEC) on success of IVF treatment and to use the model to identify EEC surface~     biomarkers for endometrial receptivity.~   "
65178|NCT02713841|"~     The purpose of this study was to compare the pharmacokinetic (PK) response after inhaled~     insulin administration with 3 different inhalation regimens and with subcutaneous insulin~     administration.~   "
65179|NCT02713828|"~     Patients with advanced or metastatic, gpNMB-expressing Squamous Cell Carcinoma (SCC) of the~     lung who have failed a prior platinum-based chemotherapy regimen will receive glembatumumab~     vedotin.~      Glembatumumab vedotin consists of an antibody (a type of human protein) attached to a drug~     called Monomethyl Auristatin E (MMAE) that can kill cancer cells. Glembatumumab vedotin is~     intended to work by specifically directing the drug to the cancer cell. It attaches to a~     molecule on the cancer cell called gpNMB, and then releases the MMAE inside the tumor cell,~     which in turn causes the cell to die.~      The purpose of this study is to see whether glembatumumab vedotin is effective in treating~     people who have advanced or metastatic squamous cell lung cancer that contains gpNMB, to~     examine how the body handles the drug and the side effects associated with glembatumumab~     vedotin.~   "
65180|NCT02713815|"~     The motivational-cognitive psychotherapy and repetitive transcranial magnetic stimulation~     (rTMS) will be used to treat amphetamine-type stimulant (ATS) addiction.~   "
65183|NCT02713776|"~     During rectal or complex digestive surgery with multiple digestive resections and~     anastomosis, the creation of enterostomy is a common procedure. In France, it is estimated~     that 20000 patients have an ileostomy and 16000 new digestive stomas are formed each year~     with approximately 30% of enterostomy. Enterostomy might sometimes give high-output not~     controlled with usual medical treatment (e.g loperamide ± codeine) and exposes the patients~     to important hydro-electrolytic loss leading to a risk for dehydration, electrolyte~     abnormalities and acute renal failure. This risk implies parenteral correction which may~     extend hospital stay and delay home return.~      Somatostatin analogues (octreotide, lanreotide and pasireotide) could reduce digestive~     secretions and decrease digestive peristalsis. Nevertheless, somatostatin analogues are not~     routinely used for the treatment of patients with high-output enterostomy and their efficacy~     in the indication (off-label) was only tested in small case series. Pasireotide (SOM230,~     SIGNIFOR®) is currently indicated for the treatment of patients with Cushing's disease for~     whom surgery is not an option or for whom surgery has failed.~      As the efficacity of pasireotide in patients with high-output enterostomy refractory to usual~     medical treatment associated with an oral fluid restriction has never been demonstrated~     before, there is a need to perform a pilot, double-blind, randomized, placebo-controlled~     trial evaluating its impact on reduction of the effluent volume.~   "
65184|NCT02713763|"~     The therapeutic goals in the management of pancreatic neuroendocrine tumors (pNET) are the~     control of symptoms and tumor growth control in order to improve patient survival.~      In recent years, data from two phase III studies with targeted therapies, sunitinib and~     everolimus, have broadened the possibilities for treatment of patients with neuroendocrine~     tumors of the pancreas.~      Unfortunately, patients progress and development of new active drugs and evaluating the best~     treatment approach is decisive.~      Given the lack of data comparing the activity of different treatment strategies, final~     decisions are based on medical experience and consensus of experts. In this context,~     different questions are still unanswered, as which is the best sequence of treatment and if~     all patients can benefit from all available drugs.~      Neuroendocrine pancreatic tumors are highly vascularized tumors in which cells may be~     dependent on this pathway for growth throughout the entire history of the tumor and in which~     inhibition of this pathway is crucial. On the other hand, this aspect has not been endorsed~     by the population of patients with pNET who have previously failed treatment with sunitinib.~      In this scenario the investigators will assess retreatment with sunitinib to evaluate the~     activity of this drug in the context of therapeutic rescue in patients with metastatic pNET.~   "
65185|NCT02713750|"~     This study will create a model of reproductive health services for HIV-positive female~     adolescents in Asia.~   "
65186|NCT02713737|"~     The investigators hypothesized that heated humidified high-flow nasal cannula oxygen(HFNC)~     along with high quality of sleep, in comparison with noninvasive positive pressure~     ventilation (NIV), could reduce the release of inflammatory marker C-reactive protein(CRP),~     which as independent predictor of atrial fibrillation（AF）, further lower the incidence of~     new-onset AF following coronary artery bypass grafting(CABG).~   "
65187|NCT02713724|"~     This study investigates whether an individualized exercise program, including a personal~     trainer, can improve cardiovascular status quantified with ultrasound to assess coronary flow~     reserve and other non-invasive techniques. The subjects in the study will be divided into two~     groups; one group will have a personalized exercise- and nutrition program and the other~     group will have acess to a gym membership, but no personal trainer.~   "
65188|NCT02713711|"~     The purpose of this study is to compare the effectiveness of artificial balneotherapy (AB),~     phototherapy (PT) and artificial balneophototherapy (BPT) in the treatment of plaque~     psoriasis, evaluating the plaque area, alteration of skin pigmentation, Psoriasis Area and~     Severity Index (PASI) score determination and quality-of-life assessment by Short Form 36~     Health Survey (SF-36) and Psoriasis Disability Index (PDI) scores during the month of~     treatment. Methods: Experimental study, prospective, randomized, single-blind. 14 subjects~     participated from the city of Talca, Chile medically diagnosed with psoriasis, more than one~     plaque in the skin without topical treatment voluntarily. All subjects completed the study~     that consisted of 12 sessions.~   "
65189|NCT02713698|"~     The main purpose of this research is to develop a population pharmacokinetic and~     pharmacodynamic model of Propofol when used for induction and maintenance of anaesthesia,~     using BIS as a pharmacodynamic endpoint.~      A covariate analysis will be performed in order to account for variability in pharmacokinetic~     and pharmacodynamic parameters. The influence of age and obesity on propofol pharmacokinetic~     parameters will be particularly addressed.~   "
65190|NCT02713685|"~     60 ASA grades- I, II or III patients, undergoing lower limb surgeries, will be randomly~     allocated in 2 groups of 30 patients each. In group S- subarachnoid block with 0.5%~     Bupivacaine (hyperbaric) 2.5ml will be given in lateral position and group B received femoral~     3 in 1 block in supine position(with landmark technique) with 20 ml of 0.25% of Bupivacaine,~     followed by Sciatic block in lateral position with 20 ml of 0.25% Bupivacaine. Onset and~     duration of sensory and motor block, time of first analgesic requirement, VAS Scores at end~     of block and surgery, hemodynamic effects, patients' and surgeon's satisfaction will be~     evaluated.~   "
65191|NCT02713672|"~     The cytochrome P450 (CYP) is a group of metabolic enzymes, from which the 2D6 and CYP2C19~     polymorphisms are specifically related to the metabolism of psychiatric drugs. The prevalence~     of CYP2D6 and CYP2C19 polymorphisms differs among ethnicities. Depending on the number of~     functional alleles, individuals are classified as Poor Metabolizer (PM), Intermediate~     Metabolizer (IM), Extensive Metabolizer (EM) or Ultra Rapid Metabolizer (UM).~      Research has suggested that PM genotype is a predisposing factor for antipsychotic-induced~     side-effects. Besides susceptibility for side effects and lower quality of life, also, a~     relationship between phenotype and costs of care has been shown.~      Guidelines recommend that PM, IM and UM genotypes need dose adjustment, to optimize the~     effectiveness of the drug and/or to reduce side effects. No research has been done to~     investigate cost-effectiveness of implementation of genotyping in daily clinical psychiatric~     practice.~      This study investigates the effectiveness of implementation of CYP2D6 and CYP2C19 genotyping~     in psychiatric patients in Curacao and analyzes the costs of genotyping versus health~     benefits.~   "
70650|NCT02642211|"~     Prospective randomized trial in patients requiring cataract surgery in which IOP, angle~     anatomy and other demographic and clinical data are compared. Subjects randomized to both~     MSICS and phakoemulsification~   "
65192|NCT02713659|"~     This study is testing the effects of early literacy promotion compared to standard literacy~     promotion at The Children's Hospital of Philadelphia. Eligible participants and their~     families will be consented and randomly assigned into either a standard literacy program or~     an early literacy program. Standard literacy will consist of the receipt of books and reading~     promotion beginning at 6 months of age, while early literacy will consist of the receipt of~     books and reading promotion beginning in the newborn period. In both groups, participants~     will receive weekly text messages until the child is 6 months old (the text messages will~     either about reading or safety) and have follow-up study visits at 6, 12, 18, and 24 months.~     The study will examine the effects of the intervention on language development and reading~     behaviors.~   "
65193|NCT02713646|"~     Up to now, multiplanar reconstruction (MPR) has been widely used to detect the neurovascular~     compressions (NVC) on the patients with idiopathic trigeminal neuralgia (ITN). However, due~     to lack of stereoscopic vision, this traditional method sometimes can not meet the~     requirement on identifying the existence and details of NVC, especially when the aberrant~     vessels turn out to be delicate veins. The three dimensional analytic techniques, such as~     curved planar reconstruction (CPR) and magnetic resonance virtual endoscopy (MRVE), may be~     helpful to improve the sensitivity and specificity on the demonstration of NVC with stereo~     and dynamic views, so as to assist to design the surgical plan.~      Furthermore, the frequent ﬁnding of NVC on MRI studies of asymptomatic patients incited the~     creation of several strict criteria for the imaging diagnosis of NVC: the vessel must cross~     perpendicular to the long axis of the nerve, the nerve must be deviated or indented at the~     root entry zoon (REZ) by the vessel. Alternatively, morphological measurement of the nerve~     may correlate with the severity of facial pain due to atrophy of the nerve in most cases of~     ITN, and is likely secondary to the micro-structural abnormalities, such as axonal loss,~     demyelination, collagen deposition, etc. In this study, cross-sectional area (CSA) and volume~     (V) of the cisternal trigeminal nerve will be assessed to determine whether it can be a~     useful biomarker for predicting the degree of ITN.~   "
65194|NCT02713633|"~     This prospective study, Randomized Trial of Indwelling Double-J Ureteral Stent Versus~     Externalized Modified-Salle Stent for Pyeloplasty will consist of four steps: 1.) Enrolling~     subjects in the study and signing the consent form 2.) Randomly divide subjects into 2~     groups, group 1 will have internal stent and group 2 will have external stent 3.) At the time~     of stent removal in the clinic or in the OR subjects parents/ subjects will fill a~     questionnaire about pain after the procedure, stent care and stent tolerance and 4) Data from~     the questionnaires and procedure cost will be collected and all the data will be analyzed~   "
65195|NCT02713620|"~     This is a follow up study from the published article entitled Comparison of immunogenicity~     and safety of four doses and four double doses vs. standard doses of hepatitis B vaccination~     in HIV-infected adults: a randomized, controlled trial by Chaiklang K, Wipasa J, Chaiwarith~     R, Praparattanapan J, Supparatpinyo K. that was published in PLoS One. 2013 Nov~     12;8(11):e80409. doi: 10.1371/journal.pone.0080409. eCollection 2013. ClinicalTrials.gov;~     NCT1289106. This study aimed to evaluate the efficacy of the HBV vaccination regimens using~     either four standard doses or four double doses compared with the current standard regimen of~     three doses in HIV-infected adults in northern Thailand. In addition, the investigators~     evaluated the efficacy of the HBV vaccination with the current standard regimen of three~     doses between healthy adults and HIV-infected patients.~   "
65196|NCT02713607|"~     Lipidome and microbiome analysis in subjects with acne on doxycycline. Investigators will~     look at the skin lipidome, blood lipidome, gut micro biome and skin micro biome.~      Investigators will look at the changes between acne subjects and control participants, but~     also the changes that occur after the use of antibiotics and how this is altered.~   "
65197|NCT02713594|"~     The study is designed to test the hypotheses that financial incentives can increase both~     participation in smoking cessation treatment and resulting cessation rates, when they are~     offered to BadgerCare Plus (Medicaid) smokers as part of their health care.~   "
65198|NCT02713581|"~     The primary objective of this study is to search for, in vitro, elements associated with~     IgG-dependent monocyte activation (signaling pathway activation, expression of pro-coagulant~     and pro-inflammatory factors) and to describe their prevalence in female patients with a~     history of proximal venous thromboembolism (proximal deep vein thrombosis or pulmonary~     embolism) compared to control women.~   "
65199|NCT02713568|"~     Macrosomia and growth restriction are important causes of perinatal morbidity, at or near to~     term. However, clear identification of 'at risk' foetuses is difficult and clinical estimates~     of fetal weight are poor. Historically, ultrasound has been used as a second line in such~     cases but the accuracy of this imaging modality in the mid- to late third trimester is also~     limited.~      Estimated fetal weight (EFW) is an important part of the clinical assessment and is used to~     guide obstetric interventions, when a fetus is small or large for dates. It frequently is the~     single most important component guiding interventions, such as induction of labour or~     Caesarean section.~      Due to the imprecision of ultrasound-derived EFW, particularly in cases of suspected~     macrosomia in the 3rd trimester, the investigators believe that these estimates should not be~     used to make important obstetric decisions regarding mode and timing of delivery and that a~     more accurate method of assessment could produce better outcomes by restricting interventions~     to those foetuses at greatest risk. Some publications have already demonstrated that magnetic~     resonance (MR) imaging derived-EFW close to delivery, is more accurate than ultrasound~      The goal of the present study is thus to compare the performance of magentic resonance~     imaging derived-EFW, versus ultrasound derived-EFW at 36 weeks of gestation, regarding the~     prediction of neonatal macrosomia.~   "
65200|NCT02713555|"~     Roux-en-Y Gastric Bypass surgery (RYGB) ameliorates type 2 diabetes within days after~     surgery. Studies indicate that the gastric sleeve procedure has comparable effect on type 2~     diabetes, but to what extent and how is not fully elucidated. This study investigates the~     effect of the surgeries on incretin levels, glucose effectiveness and hepatic insulin~     sensitivity.~   "
65201|NCT02713542|"~     This study is primarily investigating the effectiveness of Autologous Conditioned Plasma~     (ACP) Intra-articular (IA) in patients with Osteoarthritis (OA) in the knee.~   "
65202|NCT02713529|"~     A multi-center Phase 1b/2 study testing the combination of AMG 820 and pembrolizumab in~     subjects with select advanced solid tumors.~   "
65203|NCT02713516|"~     Cognitive Behavioral Therapy with fear provoking exposures is the most effective therapy for~     anxiety disorders. Investigators aim to enhance this therapy with the use of virtual reality~     exposures and to make therapy more available and accessible for patients with anxiety~     disorders. The societal benefit of increased access to therapy is that, if successful, it~     will increase the number of patients who receive appropriate treatment for an anxiety~     disorder.~   "
65204|NCT02713503|"~     The purpose of this study is to evaluate a variety of technologies in a driving simulator.~     Specifically, this research will provide a direct comparison of driver performance measures~     under various modes of mobile device interaction.~   "
65205|NCT02713490|"~     This is a Phase 4, multicenter, randomized, double-blind, controlled trial in approximately~     300 adult subjects undergoing primary unilateral TKA under spinal anesthesia with bupivacaine~     HCl (10-15 mg).~   "
65206|NCT02713477|"~     Primary Objective:~      To assess the postprandial glucodynamic response to 2 doses of insulin glargine/lixisenatide~     fixed-ratio combination compared to placebo in Japanese patients with type 2 diabetes~     mellitus (T2DM).~      Secondary Objectives:~        -  To assess the pharmacokinetics (PK) of lixisenatide following administration of 2~          different doses of insulin glargine/lixisenatide fixed-ratio combination in Japanese~          patients with T2DM.~        -  To assess the postprandial glucodynamic response to insulin glargine/lixisenatide~          fixed-ratio combination compared to insulin glargine alone in Japanese patients with~          T2DM.~        -  To assess the safety and tolerability of insulin glargine/lixisenatide fixed-ratio~          combination in Japanese patients with T2DM.~   "
65207|NCT02713464|"~     This study examines (a) whether introduction of public, health provider, and maternal~     education about risks of jaundice will decrease the occurrence of ABE compared with baseline~     prevalence (before-after design) or (b) whether antenatal or postpartum instruction to~     mothers will decrease the incidence of ABE compared with those who did not received~     instruction (concurrent opportunistic controls in phase 2).~   "
65208|NCT02713451|"~     No clear recommendation exists for the level of oxygenation of intensive care patients. In~     Acute Respiratory Distress Syndrome (ARDS), pulsed oxymetry (SpO2) have to be kept between 88~     and 95 percent and oxygen alveolar pressure between 55 and 80 mmHg (PaO2). These~     recommendations are common but do not lie on high scientific knowledge and level of proof. In~     the major studies of these fifteen last years that changed ARDS management, PaO2 was kept~     around 85 and 90 mmHg despite current recommendations of 55 to 80 mmHg of PaO2.~      Many recent review and cohort studies pointed the risk of excessive oxygenation especially~     following cardiac arrest, stroke or traumatic brain injury. However, these data come in~     majority from cohort or database study without strong definition of hyperoxia. Data coming~     from prospective studies are scarce and tend to show better outcome of patients with lower~     objectives of oxygenation in ICU.~      High oxygen (O2) level may be deleterious especially on inflammatory lungs. It could enhance~     injuries due to mechanical ventilation. O2 could be responsable of  hyperoxia induced lung~     injury .~      The investigators showed in a precedent study that comparing a restrictive oxygenation versus~     a liberal oxygenation was feasable and do not expose patients to major adverse events. More,~     mortality at 60 days has tendency to be lower. The investigators therefore ask if a lower~     objectives of PaO2 in comparison with the level usually seen in last studies on ARDS could~     improve ARDS patients outcome.~      The aim of this study is to show that a restrictive oxygenation in comparison with a liberal~     oxygenation strategy in patients with ARDS would lower mortality at 28 days.~   "
65209|NCT02713438|"~     AIMS: The project aims at investigating of the effects of three types of planning (individual~     planning, collaborative planning, and dyadic planning) on physical activity.The influence of~     three planning interventions are compared with an active control condition, including~     physical activity education.~      PARTICIPANTS: The effects of the interventions are evaluated among parent-child (aged 10-14)~     dyads, with a minimum of 50 dyads enrolled into the each arm of the trial (a total of 200~     dyads). The interventions consist of six planning sessions.~      DESIGN: The dyads are randomly assigned to one of four experimental conditions. The~     assessment of the main and secondary outcomes is conducted at the baseline, at 1 week after~     the first intervention session, at post-intervention (after six intervention sessions are~     completed), and at 6-, and 12-month follow-ups.~      OUTCOMES: Physical activity constitutes the main outcome, whereas health-related quality of~     life (HRQOL), body mass index, as well as the self-regulatory strategy called the use of~     planning (individual, dyadic and collaborative) are secondary outcomes.~   "
65210|NCT02713425|"~     This research study aims to test the feasibility and effectiveness of using an entertaining~     video game as an addition to traditional therapy for the treatment of anxiety disorders in~     youth, particularly those youth who may have limited access to mental health treatment in the~     traditional clinical setting.~   "
65211|NCT02713412|"~     To determine whether the changes in blood pressure (BP) which occur following meals in normal~     people and patients who have substantial falls in BP after a meal postprandial hypotension~     (PPH)) are associated with changes in cardiac function. Eligible subjects who have been~     previously diagnosed with PPH will report to the Queen Elizabeth Hospital, on two occasions,~     following an overnight fast. Subjects will be cannulated and have a BP cuff placed around~     their upper arm. Following this, subjects will ingest either a drink containing 75 grams of~     glucose and 150mg of a C13 Acetate (which is metabolised and excreted in the breath, enabling~     noninvasive measurements of gastric emptying), made up to 300mL water, or on the other study~     day, 300mL water alone. The order of the study days will be randomised. Following the drink,~     for 3 hours, measurements will be taken at regular intervals of BP, heart rate, breath~     samples (on the study day with the Acetate only), blood samples (for measurement of blood~     glucose and gut hormones) and transthoracic echocardiography (TTE) (for assessment of end~     systolic and diastolic cardiac volume, cardiac output, cardiac contractility and diastolic~     function). After the 3 hours of measurements, the cannula will be removed and subjects will~     be offered lunch prior to leaving the department. Following lunch, on one study day, subjects~     will have their autonomic nerve function tested noninvasively, using an ECG.~   "
65224|NCT02713243|"~     The purpose of this study is to determine whether LJN452 improves the symptoms of bile acid~     diarrhea and to assess its safety and tolerability profile in patients with primary bile acid~     diarrhea (pBAD) to guide decision-making regarding further clinical development in this~     indication.~   "
65212|NCT02713399|"~     A refractive error is the most common reason for reduced visual acuity. Myopia, hyperopia,~     astigmatism and presbyopia belong to the four basic refractive errors and, unfortunately,~     cannot be prevented. There are different tools to correct them, like spectacles, contact~     lenses, and refractive surgery. Many different contact lenses are available, the two large~     groups create rigid contact lenses and soft contact lenses. It is a common knowledge that the~     presence of a contact lens in the eye divides the tear film into the prelens and postlens~     tear film layers. In the present study we want to investigate the variability and~     reproducibility of prelens and postlens tear film thickness measurements.~   "
65213|NCT02713386|"~     This phase I/II partially randomized trial studies the side effects and the best dose of~     ruxolitinib phosphate when given together with paclitaxel and carboplatin and to see how well~     they work in treating patients with stage III-IV epithelial ovarian, fallopian tube, or~     primary peritoneal cancer. Ruxolitinib phosphate may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as~     paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either~     by killing the cells, by stopping them from dividing, or by stopping them from spreading.~     Giving ruxolitinib phosphate together with paclitaxel and carboplatin may be a better~     treatment for epithelial ovarian, fallopian tube, or primary peritoneal cancer.~   "
65214|NCT02713373|"~     This phase I/II trial studies the side effects and best dose of cetuximab when given together~     with pembrolizumab in treating patients with colorectal cancer that has spread from the~     primary site (place where it started) to other places in the body (metastatic) or that cannot~     be removed by surgery. Monoclonal antibodies, such as cetixumab and pembrolizumab, may block~     tumor growth in different ways by targeting certain cells.~   "
65215|NCT02713360|"~     The hypothesis is that there is a significant difference in anxiety scores between~     intervention and usual care group after intervention.~      The aim of this randomised trial is (I) to determine the type of anxiety in ICD patients and~     (ii) to investigate the effect of screening followed by randomisation to intervention with~     consultations based on cognitive therapeutic principals to reduce anxiety in patients with~     ICD or usual care.~   "
65216|NCT02713347|"~     Chronic heart failure (CHF) and chronic obstructive pulmonary disease (COPD) are common~     serious illnesses. Despite disease-specific medical care for CHF and COPD, people with either~     illness are often left with poor quality of life (i.e., burdensome symptoms, impaired~     function). Furthermore, while CHF and COPD are leading causes of hospitalization and~     mortality, few people with either illness engage in advance care planning, the process of~     considering and communicating healthcare values and goals. The investigators are conducting a~     randomized clinical trial to study a symptom management, psychosocial care and advance care~     planning intervention to improve quality of life. The study is important because it aims to~     improve quality of life and provision of care according to peoples' goals and preferences in~     common, burdensome illnesses. Furthermore, this study will generate information that supports~     the broader dissemination and implementation of the intervention and informs the development~     of future palliative care and team-based interventions in the VA.~   "
65217|NCT02713334|"~     The objective of this protocol is to characterize cancer patients' responses to learning~     their secondary findings arising from tumor genomic profiling, and the process and outcomes~     of their decisions to communicate these results to their families.~   "
65218|NCT02713321|"~     Type 2 diabetes is common in the United States; about 1 in 10 people have the disease.~     Diabetes can cause devastating health events, such as hospitalizations, kidney failure,~     blindness, amputation, heart attack, stroke, painful nerve damage (neuropathy), and death.~     There are many barriers for patients with diabetes that get in the way of controlling risk~     factors, following recommendations, and getting the care they need from the health system to~     help prevent these complications; this is especially true for those with other health~     problems too. Those living in poverty and racial/ethnic minorities are more likely to have~     complications from diabetes, and less likely to get recommended care from health systems. In~     order to improve care and outcomes for people with complex medical problems, several states~     have started the Medicaid Health Home (HH) program, including New York State (NYS) in 2012.~     This program is for people with two or more chronic health conditions, such as diabetes and~     heart disease, people with HIV, and people with a serious mental health condition. HHs are~     meant to manage and coordinate care, by helping health care providers, social service~     agencies, community-based organizations, and health insurance plans work together. Similar~     programs have been shown, on a smaller scale, to improve some results for patients with~     diabetes, such as lab tests indicating level of diabetes control. Studies have not yet looked~     at how a large program like HHs impacts the way healthcare is delivered and impacts the~     health events that matter most to patients with diabetes. Also, few studies include~     stakeholders on the research team, even though they stand to benefit the most from such~     programs, and have the experience needed as patients, clinicians, advocates, and~     administrators to guide efforts. The investigators have gathered a research team that~     includes scientific investigators along with a diverse group of partners, including patients,~     clinicians, and program administrators. The investigators plan to use two data sources that~     show what happens to individual patients over time: 1) NYS Medicaid insurance data 2) the New~     York City-Clinical Data Research Network (NYC-CDRN). The NYC-CDRN has identified a group of~     patients with diabetes from 7 large health systems; it has also developed a system for~     putting together the same set of information for each patient, and removing any identifying~     information. The investigator will look at patients who have diabetes and are part of a HH~     and study what happened to them over time. The investigator will also look at a comparison~     group of patients who are very similar to the HH patients, but they did not join a HH, and~     follow them over time. The investigator will then compare these two groups to each other. The~     investigator will look at the quality of healthcare they received and their health outcomes.~     The investigator will focus on health outcomes that are meaningful to patients. This study~     can provide important knowledge about the effects of the HH program on patients with~     diabetes.~   "
65219|NCT02713308|"~     Observational, retrospective and perspective study with acute and chronic endpoints~   "
65220|NCT02713295|"~     This study estimates the treatment goal achievement rate, depicts the implementation of the~     Progressive Psoriasis Initiative (PPI) recommendations regarding treatment modifications and~     transitioning, and assesses patient adherence and persistence with adalimumab therapy in the~     routine clinical practice in Greece.~   "
65221|NCT02713282|"~     The purpose of this study is to estimate the proportion of participants fulfilling criteria~     for symptomatic remission following a transition to 12 months treatment with flexible-dose~     paliperidone palmitate 3 month formulation (PP3M) in participants with schizophrenia~     previously adequately treated with paliperidone palmitate 1 month formulation (PP1M) for at~     least 4 months.~   "
65222|NCT02713269|"~     The goal of this clinical research study is to find out if combining thermal ablation (using~     a laser to heat tumor tissue in order to shrink the tumor size) and spine stereotactic~     radiosurgery (SSRS--a method for giving radiation) can help control cancer that has spread to~     the spine.~   "
65223|NCT02713256|"~     An open label study to evaluate the safety and efficacy of CFZ533 following 12 weeks~     treatment in patients with Graves' disease~   "
65225|NCT02713230|"~     This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study in~     approximately 120 adult subjects undergoing primary unilateral total shoulder arthroplasty or~     rotator cuff repair with general anesthesia~   "
65226|NCT02713217|"~     Integrating mental health treatments into the primary care delivered at Community Based~     Outpatient Clinics(CBOCs) that are geographically accessible to rural Veterans is a major~     priority for the Department of Veterans Affairs. However, there is no scientific evidence~     that integrating mental health and primary care is clinically effective at smaller CBOCs that~     have limited mental health staffing. The goal of this proposed project is to implement a~     blended combination of integrated care models that have been adapted for smaller CBOCs~     using telemedicine technologies, and evaluate the acceptability and effectiveness of the~     blended, telemedicine-based, integrated care model. If clinical outcomes are improved~     compared to usual care, findings will be used to justify and facilitate the implementation of~     this telemedicine-based integrated care model at smaller CBOCs in order to increase rural~     Veterans' access to effective mental health treatments.~   "
65227|NCT02713204|"~     The primary objective of the study is to compare the efficacy of intravitreal~     (IVT)-administered REGN910-3 compared to intravitreal aflibercept injection (IAI).~   "
65228|NCT02713191|"~     The randomized controlled trial will compare efficacy and safety of dexmedetomidine to~     midazolam for sedation during endobronchial ultrasound~   "
65229|NCT02713178|"~     This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study in~     approximately 300 adult subjects undergoing primary unilateral TKA under general or spinal~     anesthesia.~   "
65230|NCT02713165|"~     Raisins contain a significant amount of dietary fiber and polyphenolic compounds that~     represent an important substrate for microbiota fermentation which generates potentially~     beneficial end products, such as short-chain fatty acids. The mammalian gut contains a~     phylogenetically as well as functionally diverse microbiota that contributes to host~     physiology. To date, little is known about how increased raisin intake affects human gut~     microbiota composition.~      This research study will assess the effects of adding raisins to the diet of healthy adults~     on the bacteria from feces of human subjects and resulting self-reported GI symptoms as well~     as markers of immune function. The hypothesis is that by adding raisins to the diet this will~     result in changes in gut microbiota. Furthermore, the changes in microbiota will largely be~     beneficial, as evaluated by an increase in butyrate producers and bacteria associated with~     anti-inflammatory properties.~   "
65231|NCT02713152|"~     This study aims to investigate a potential link between Obstructive Sleep Apnoea (OSA) and~     Open Angle Glaucoma (OAG); initially by determining whether the prevalence of OSA is higher~     in patients with OAG in comparison to people without glaucoma and if OSA is an independent~     risk factor for OAG. It will comprehensively phenotype glaucoma patients for variables that~     may be associated with both OSA and OAG.~   "
65232|NCT02713139|"~     The purpose of this study is to determine the efficacy and safety of the association~     clotrimazole 200mg and metronidazole 0,75%(Clopistatin 5DT®) and whether it is superior when~     compared with metronidazole 100mg/g (gynecologic Flagyl®) and clotrimazole 20mg/g~     (Gino-Canesten® 3) in the syndromic treatment of vaginal discharge from different etiologies.~   "
65233|NCT02713126|"~     Participants with heart failure with preserved ejection fraction will undergo 12 weeks of~     cardiac rehabilitation for exercise training (ET) and be randomized to either nebulized~     sodium nitrite inhalation solution or placebo inhalation solution (normal saline) through the~     training period. Study drug is administered 3 times daily during daytime hours with one of~     these doses being immediately prior to onset of ET sessions throughout the 12 week trial. The~     objective is to determine if the inhaled sodium nitrite improves the clinical responses and~     tolerability of ET.~   "
65234|NCT02713113|"~     the investigators aimed to compare the efficacy and safety of sugammadex at doses of 1.5, 2,~     and 4 mg/ kg for the reversal of moderate rocuronium-induced neuromuscular blockade in~     laparoscopic bariatric surgery.~   "
65235|NCT02713100|"~     In recent years, there has been an emphasis on assessing patient's pain on presentation to~     emergency departments. The Joint Commission mandates that all patients who present with pain~     must have a pain assessment performed and addressed early in their care. Most emergency~     departments are using a self-reported assessment of pain using a 1-10 scale of pain. This~     self-reported level of pain is used to determining appropriate treatment. The Joint~     Commission has only dealt with somatic pain and has not addressed psychological related pain.~      Many authors have written on psychological pain. It is described as introspective experience~     of negative emotions such as anger, despair, fear, grief, shame, guilt, hopelessness,~     loneliness and loss. The assessment of psychological pain has been used to describe patients~     with depression and suicidal thoughts and behaviors.~      Study Significance The significance of this study is to determine if patients can communicate~     the level of psychological pain using the level of agitation as a surrogate marker. Studies~     have demonstrated that the staff's assessment of a patient's level of agitation is not based~     on an agitation scale nor uses any patient self-assessment of their level of agitation. If a~     self-assessment of a patient's level of agitation can be determined early in their care in~     the emergency setting, a proactive approach to treatment can occur. Proactive agitation~     treatment has the potential of reducing a patient's agitation and increasing their level of~     comfort. This early intervention can reduce the progression of agitation and the risk of~     injury to patients, families and staff.~      Hypothesis The study null hypothesis is that the self-rated agitation scale will not have a~     significant level of correlation with the other measures of agitation (Brief Agitation~     Measure, Positive And Negative Syndrome Scale and Agitation Calmness Evaluation Scale). The~     secondary null hypothesis is that there is no difference between the level of agitation and~     the level of psychological pain, assessed with the Psychological Pain Assessment.~   "
65236|NCT02713087|"~     Project title: Influence of Vasopressors on Brain Oxygenation and Microcirculation in~     Anesthetized Patients with Cerebral Tumors~      Sponsor-investigator: Klaus Ulrik Koch M.D.~      Sponsor: Department of Anesthesia Aarhus University Hospital, Nørrebrogade 44, 8000 Aarhus C,~     Denmark~      Objective:~      To investigate whether phenylephrine and ephedrine causes different alterations in~     microcirculation and oxygenation, as measured with MRI and PET, in anesthetized patients with~     brain tumors. Using MRI and PET, the study will assess whether there is a difference in~     deoxyhemoglobin concentration (Bold signal), CTTH, cerebral blood flow (CBF) and cerebral~     metabolic rate of oxygen (CMRO2) between ephedrine and phenylephrine~      Method:~      Double blinded controlled randomized clinical trial. Either phenylephrine or ephedrine are~     infused intravenously under general anesthesia. MRI is performed in 20 patients before and~     after infusion. PET/CT is performed in 20 patients before and after infusion. BIS and NIRS~     monitoring will be used in either scanner. After scanning patients are transported to the~     operating theatre and the craniotomy is performed. After removal of the bone flap subdural~     ICP is measured and recorded.~      MRI to analyze CBF, CTH, max.CMRO2, maxOEF, CBV and grey-scale ADC before and after ephedrine~     and phenylephrine. PET/CT to analyze CBF and CMRO2 before and after ephedrine and~     phenylephrine and calculation of OEF. During each PET/CT scan session oxygen saturation and~     hemoglobin concentration is measured.~      Data from the proposed studies will add substantial new knowledge to the investigators~     current understanding of the effects of vasopressors on cerebral circulation. This~     information will aid the neuroanesthesiologist, neurointensivist and the neurosurgeon in the~     choice of the optimal method to manage cerebral perfusion pressure during craniotomy for~     brain tumor.~   "
65237|NCT02713074|"~     The normal saline is used in medicine as an intravenous isotonic infusion and for cleaning~     wounds. It is a mild but effective cleaning agent and will not harm normal tissue, unlike~     many stronger antiseptics. It is available and inexpensive in comparison to povidone iodine.~   "
65238|NCT02713061|"~     This clinical trial is a Phase 2 study of a single subcutaneous injection of TAK-850 for 22~     days in healthy Japanese adults.~   "
65239|NCT02713048|"~     Troponin is a major diagnostic criterion of acute myocardial infarction (AMI) which confirms~     myocardial damage and necrosis. In out-of-hospital cardiac arrest (OHCA) patients its~     dynamics and diagnostic value is often controversial and has not been well described. Most of~     prior studies were retrospective, using first generation troponin assays and assessing only~     admission troponin. The aim of this work is to correlate dynamics of sensitive troponin I~     with urgent coronary angiography.~      Patients resuscitated after OHCA will be prospectively divided in three groups based on the~     results of their urgent angiographies. Serial assessment of sensitive troponin I will be~     obtained over initial 48 hours.~      We expect admission troponin will not be predictive of AMI. Over next hours troponin levels~     will be highest in patients with acute coronary lesion, lower in stable obstructive coronary~     disease and insignificant in non-obstructive coronary disease. We also expect significant~     difference in highest values and dynamics of troponin in sub-group with spontaneous~     reperfusion (TIMI flow 2 and 3) comparing to patients with coronary occlusion (TIMI flow 0~     and 1). In patients with non-obstructive disease we expect troponin levels to correlate with~     duration of cardiac arrest, number of external electric shocks and cumulative dose of~     adrenaline administered.~   "
65240|NCT02713035|"~     Patients with atopic dermatitis and eczema often struggle with habitual scratching that is~     not well-controlled even with optimal medical therapy. Our goal is to create a behavioral~     intervention to help children with eczema reduce scratching. The investigators hope that the~     intervention will improve clinical outcomes and quality of life, as well as provide an easily~     implemented way for clinicians to educate patients and parents about behavioral modification~     techniques.~   "
65241|NCT02713022|"~     The investigators want to find a better way to predict the risk of having fatty tissue~     inflammation by using a different approach to finding out body fat composition. In this~     study, the investigators want to estimate the body fat composition using a DEXA scan. DEXA~     stands for dual energy X-ray absorptiometry. It is the standard and established test to~     determine bone mineral density (how strong the bones are) to diagnose osteoporosis. This test~     can also be used to determine the body composition including percent body fat and lean mass.~     The investigators will compare the participants DEXA scan results for body fat composition to~     the inflammation found in the breast tissue from the mastectomy to see if there is a~     relationship. If successful, this may help us predict which patients may be at risk for~     breast cancer in the future. In addition, the investigators will compare the participants~     DEXA scan results for body fat composition and inflammation found in the fat tissue from the~     mastectomy or prostatectomy to the level of exercise activity as measured by a short~     questionnaire to see if there is a relationship. The investigators will also measure the~     participants waist to hip ratio.~      Finally, at the time the participant has blood drawn for their standard presurgical testing,~     the investigators will also test the blood for prediabetes using a blood test called~     hemoglocin A1c. The investigators will also measure for the participants waist to hip ratio,~     and a Hgb A1c blood drawn will be take at the time of presurgical testing. If not feasible,~     Hgb A1c can be drawn at a separate visit prior to the DEXA scan. If successful, this may help~     us predict which patients may be at risk for breast cancer in the future.~   "
65242|NCT02713009|"~     Research shows high levels of vitamin D deficiency in pregnant women in Northern Ireland.~     Body composition is a determinant of vitamin D status. Vitamin D is a fat soluble vitamin and~     therefore may be hidden within the adipose/fat tissue in overweight/obese individuals. All~     pregnant and breastfeeding women are advised to take a daily supplement containing 10μg~     vitamin D. The investigators hypothesise that overweight/ obese pregnant women have a lower~     vitamin D status than their leaner counterparts at the start of pregnancy and may need a~     higher daily supplementation to achieve a sufficient status.~      The investigators propose a randomised supplementation study where pregnant women (n 240)~     from the Western Health and Social Care Trust Area will be invited to take part.~      Inclusion criteria: pregnant women first trimester, without current pregnancy related~     complications, singleton pregnancy, aged ≥18 years, with Body Mass Index (BMI) > 18.5kg /m².~      Participants will be randomised to receive either 0μg (placebo) plus a multivitamin or 10μg~     vitamin D plus a multivitamin from 12 weeks gestation until delivery. The multivitamin~     already contains 10μg vitamin D; Therefore participants will be randomised to receive a total~     of 10μg or 20μg vitamin D.~      Blood samples (20mls) will be taken at 12, 28 and 36 weeks gestation. A sample of blood will~     be taken from the cord after delivery. Vitamin D status is the main outcome measurement. All~     blood samples will be analysed for vitamin D and other associated metabolites. Data will be~     collected on health and lifestyle, supplementation use and food intake. Body composition~     measurements will be recorded at each appointment and infant anthropometric measurements will~     be taken from the maternal notes after delivery. Findings from this research will be used to~     inform nutrition policy on appropriate vitamin D supplementation levels in pregnancy which~     may be dependent upon pre pregnancy BMI.~   "
65243|NCT02712996|"~     The purpose of this research study is to evaluate whether Vyvanse, a psychostimulant, can~     help children ages 6-16 with attention deficits due to traumatic brain injury (TBI). Vyvanse~     is currently approved for the treatment of Attention-Deficit/Hyperactivity (ADHD). The exact~     effects this drug may have on adults with attention deficits caused by TBI have been~     investigated prior. The exact effects this drug may have on children with attention deficits~     caused by TBI are not known, but the investigators expect that Vyvanse will be of some help~     in treating this population as well.~   "
65244|NCT02712983|"~     The purpose of this study is to support the selection of a safe and tolerable tobramycin~     inhalation powder (TIP) dose, and regimen that exhibits effective bacterial reduction of P.~     aeruginosa in non-cystic fibrosis bronchiectasis (BE) patients with P. aeruginosa~     colonization.~   "
65245|NCT02712970|"~     A staging system was defined based on morphological extent of disease (stage I to stage IV~     for primary disease, and stage R for recurrent disease). Specific surgical technique was used~     for each stage. Demographics, perioperative data, short-term and long-term outcomes were~     evaluated according to the disease stage.~   "
65246|NCT02712957|"~     The purpose of this study is to assess NEO6860, a modality selective TRPV1 antagonist, in~     patients with pain associated with osteoarthritis of the knee.~   "
65247|NCT02712944|"~     The purpose of this trial is to evaluate the effect of testosterone replacement in men with~     renal failure (on dialysis) who also have low testosterone. Specifically, the investigators~     will assess the change in requirement of Erythropoietin Stimulating agents.~   "
65248|NCT02712918|"~     The purpose of the current study was to examine Brief Behavioral Activation Treatment for~     Depressions (BATD) effectiveness, credibility, and acceptability with moderate to severly~     depressed inpatients. The study is a systematic replication of a randomized controlled trail~     from 2003, that provided initial support for BATD With inpatients. The current study compared~     BATD to Treatment as Usual in a randomized controlled trial.~   "
65291|NCT02712359|"~     The purpose of this study is to evaluate the persistence of hepatitis A antibodies,~     approximately 8 years and 10 years post vaccination with the complete series of Havrix (2~     doses) and the partial series completion (1 dose).~   "
65249|NCT02712905|"~     This is an open-label, dose-escalation/dose-expansion study of INCB059872 in subjects with~     advanced malignancies. The study will be conducted in 4 parts. Part 1 (mono therapy dose~     escalation) will determine the recommended dose(s) of INCB059872 for dose expansion, based on~     maximum tolerated dose and/or a tolerated pharmacologically active dose. Part 2 (dose~     expansion) will further determine the safety, tolerability, efficacy, PK, and PD of the~     selected monotherapy dose(s) in AML/MDS, SCLC, myelofibrosis, Ewing sarcoma, and poorly~     differentiated neuroendocrine tumors. Part 3 will determine the recommended dose(s) of~     INCB059872 in combination with azacitadine and all-trans retinoic acid in AML and in~     combination with nivolumab in SCLC. Part 4 will further determine the safety, tolerability,~     efficacy, PK, and PD of the selected combination dose(s) in Part 3.~   "
65250|NCT02712892|"~     Intracranial aneurysm (IA) is an asymptomatic cerebrovascular abnormality affecting 3.2% of~     the general population. The devastating complication of IA is its rupture, resulting in~     subarachnoid haemorrhage that can lead to severe disability and death. Unfortunately, there~     are neither reliable clues nor diagnostic tools to predict the formation and/or the fate of~     an IA in a given individual. Also, there is no pharmacological drug available to prevent the~     rupture of aneurysm and subsequent subarachnoid haemorrhage. Current treatments are invasive~     with a significant risk of procedural morbidity. Thus, still now, the management of patients~     with IA remains extremely challenging and still controversial. Although the pathogenesis of~     IA has been the subject of many studies for the last decade, the mechanisms underlying IA~     formation, growth and rupture are still mostly unknown and relevant animal models of IA are~     not available. Familial history of IA predisposes to IA formation and rupture and increasing~     evidence suggest a genetic component of IA formation, with heterogeneous modes of inheritance~     and penetrance. This project, gathering neuroradiologists, geneticists and vascular~     biologists, addresses the urgent need to understand the pathogenic mechanisms of IA to~     develop diagnostic and predictive tools of risk of IA. The investigators propose to identify~     IA-causing variants by whole-exome sequencing in familial forms of the disease. The~     investigators hypothesises that the functional analysis of the causal/susceptibility variants~     thus identified will provide clues to understanding the pathological mechanisms of IA~     formation, and the bases for developing diagnostic tools. This project aims at meeting this~     challenge. Based on preliminary data that already allowed to identify such a variant, and the~     combination of genetic and functional investigations, the specific objectives of this project~     are: - To identify IA-causing variants in familial forms of the disease by whole-exome~     sequencing; - To understand the function of these genes/variants in the formation and rupture~     of IA by molecular and cellular approaches and generation of relevant animal models; - To~     discover potential biomarkers of risk of IA formation and/or rupture.~   "
65251|NCT02712879|"~     Determine a bleeding threshold by measuring the blood volume in ml / kg / h collected in the~     drainage system to define moderate bleeding postoperative cardiac surgery and define the~     population.~   "
65252|NCT02712866|"~     Background: Infiltration of GI by T lymphocytes is a pathogenic mechanism both in ulcerative~     colitis (UC) and in Crohn's disease (CD). Vedolizumab (VDZ) is a humanized monoclonal~     antibody binding with high affinity to α4β7 integrin blocking α4β7+-MAdCAM-1 interaction,~     hence blocking a key step in GI lymphocytes T infiltration. VDZ has demonstrated a~     therapeutic effect in UC and CD. Investigators still lack of adequate biomarkers to predict~     clinical response to biological treatments, specially avoiding invasive procedures.~      Objective: Study whether circulating CD4+ and CD8+ α4β7+ memory T lymphocytes and some of~     their surface markers might be molecular markers of response to VDZ treatment in patients~     with UC and CD.~      Methods: Prospective (pilot) study including 24 adult IBD patients (12 UC patients and 12 CD~     patients (patients with fistulizing perianal disease will be excluded) with active disease~     and prior failure to anti-TNFα treatments starting treatment with VDZ. They will received VDZ~     in standard induction (300mg intravenously, 0-2-6 weeks) and maintenance schemes (300mg~     intravenously, every 8 weeks).~      Epidemiological and clinical data from every patient will be recorded prospectively. Disease~     activity at weeks 0, 2, 6 and 14 weeks will be evaluated through validated clinical scores,~     biological parameters and fecal biomarkers.~      At week 14 response to the treatment will be evaluated by ileocolonoscopy or enteroMRI.~      Peripheral blood will be obtained from every patient at baseline, before the third infusion~     of VDZ (6th week) and before the first maintenance dose (14th week).~      Blood lymphocytes will be isolated and multicolor flow cytometry will be performed on stored~     circulating memory T cells.~      Percentage and absolute values of circulating CD4+ and CD8+ α4β7+ memory T lymphocytes as~     well as several surface markers related to their activation state (HLA-DR, CD25), Th17~     phenotype (IL23R, CCR6, intracellular IL17A) and Th1 phenotype (INFγ)will be assessed on~     α4β7+ memory T cells.~   "
65253|NCT02712853|"~     The goal of this project is to identify specific miRNAs that are increased or decreased in~     the saliva of children with developmental delay and are useful for screening toddlers for~     ASD. Such a screening tool would improve the specificity of diagnosis, streamline referrals~     to developmental specialists, and expedite the arrangement of early intervention services.~   "
65254|NCT02712840|"~     The purpose of this study is to determine whether the chances of becoming pregnant are better~     when day the single best day 5 embryo (blastocyst) resulting from an in vitro fertilization~     (IVF) cycle is transferred into the uterus immediately, or after freezing the embryo and~     transferring it into the uterus in a subsequent cycle, separate from the ovarian stimulation~     used in the IVF cycle. The investigators hypothesize that in good-prognosis patients,~     vitrified-warmed elective single embryo transfer will result in higher implantation, clinical~     and on-going pregnancy and live birth rates than fresh elective single embryo transfer at the~     blastocyst stage.~   "
65255|NCT02712827|"~     The placement of mesh is important in hernia surgery as it helps to reduce recurrence, yet~     the method of fixation of mesh may cause pain after surgery. In laparoscopic hernia repair,~     surgeon uses different methods to fix the mesh in large hernia defects or bilateral inguinal~     hernias. Progrip is a special mesh developed by manufacturer that it can be self-gripped to~     tissue, as a result no fixation is required after placement. There are few data about Progrip~     in laparoscopic hernia repair. In this randomized controlled trial we would like to compare~     the use of Progrip with the conventional mesh in laparoscopic hernia repair. Surgery is~     performed in the usual manner; prior to placement of mesh, surgeon will get the randomization~     result for that particular patient: Progrip and non-Progrip group. No fixation is required~     for Progrip group, while fixation with fibrin glue is needed for non-Progrip group.~     Intraoperative data (e.g. mesh deployment time, operative time, etc) will be collected.~     Patients will be assessed in clinic at 2-week, 3-month, 6-month and 1-year interval after~     surgery. Additional visits may be arranged if considered necessary. At follow up patient will~     be seen by surgeon first to review the wound condition and to look for any recurrence; while~     other post-operative data including total analgesic usage (number of tablets), return to~     normal activities (days), return to work (days), pain score etc will be assessed and recorded~     by a trained nurse who is blinded to the treatment that patient received. Any hernia~     recurrence will be recorded and treated accordingly. Primary aim of this study is to look for~     any difference of the 2 groups in terms of postoperative pain and quality of life scores.~   "
65292|NCT02712346|"~     The primary goal of the study is to determine the safety and tolerability of ambrisentan. It~     is also expected that ambrisentan will improve blood flow in the lungs, decrease~     inflammation, and reduce pain in sickle cell patients. An additional goal is to evaluate the~     use of select biomarkers in evaluating sickle nephropathy.~   "
65293|NCT02712333|"~     This study aims to detect serum metabolite changes, as well as other health indicators with~     the intervention of air purifiers on a randomized, crossover, double-blind trial.~   "
65256|NCT02712814|"~     The proposed study will evaluate a clinical algorithm for the diagnosis and treatment of~     provoked vestibulodynia (PVD). The algorithm, distinguishes between four subtypes of PVD:~     hormonally mediated PVD, hypertonic pelvic floor dysfunction, congenital neuroproliferative~     PVD and acquired neuroproliferative PVD, based on a patient's history and physical exam. The~     study will follow patients diagnosed with PVD, for one year, and evaluate the treatment~     outcome in the different subgroups. Investigators hope that conducting a prospective study,~     showing clinical benefit and improved outcome for patients classified according to this~     method may change the common practice of trial and error based treatment, and will improve~     clinical results.~   "
65257|NCT02712801|"~     This is a multi-center, randomized, controlled, open clinical trial. The trial will be~     carried out in five provinces in China. Pregnant women with HIV infection and at high risk of~     mother-to-child transmission of HIV will be identified. Their newborn babies who are at high~     risk HIV infection will be recruited and randomized into intervention and control groups.~     Children in intervention groups will receive ART and intensive HIV testing after birth.~     Children in control group will receive routine prevention of mother-to-child transmission~     services. All the included children will be followed up and their development and infection~     status will be recorded and compared.~   "
65258|NCT02712788|"~     The purpose of this study is to evaluate the usefulness of adding Milrinone to the current~     standard treatment for cerebral vasospasm.~   "
65259|NCT02712775|"~     Liver transplantation is the sole therapy for end-stage liver diseases and acute liver~     failure in children and adults. However, use of this life-saving technique is limited due to~     a severe shortage of donor livers. The number of transplants currently performed is~     approximately one-third of the number needed to accommodate the more than 16,000 patients~     awaiting an organ in the US. Over 20% of patients on the liver transplant waiting list die~     prior to transplantation due to organ shortages. The median waiting time in 2011 was over 300~     days. Poor immediate graft function and primary non function (PNF) are clinically significant~     events, especially in recipients of marginal livers (elderly donors, extended cold storage~     time, or steatosis). PNF has dramatic effects on patient morbidity and mortality,~     necessitating prolonged and expensive stays in intensive care units, and re-transplantation~     is the only life-saving therapy in patients with failing liver grafts due to PNF. This~     further exerts greater burden on the already scarce donor organ pool. Furthermore, biliary~     strictures and ischemic cholangiopathy, as a result of severe ischemia reperfusion injury,~     cause prolonged hospital stay, long-term complications, and increased costs. Targeted~     treatments, such as the one proposed in this application, will reduce the need for~     re-transplantation, reduce biliary injury, and potentially increase the number of donor~     organs available.~   "
65260|NCT02712762|"~     This study aims to profile the ocular surface inflammation of chronic Graft-Versus-Host~     Disease patients by investigating conjunctival cells, and clinical imaging for conjunctival~     redness and tear stability. Hence, the investigators expect to find an increased in~     inflammatory cell population in GVHD conjunctival samples.~   "
65261|NCT02712749|"~     The Investigators verify the effectiveness of Binaural Beats as premedication instrument in~     elderly patients submitted to major surgery, in order to reduce the preoperative stress and~     possibly limit the use of sedatives and anti-anxiety medications.~   "
65262|NCT02712736|"~     The purpose of this study is to assess the healthcare-related quality of life (HRQOL), the~     impact of risk of liver transplant and risk of malignancy on HRQOL, and the complementary and~     alternative medicine use in patients with PSC.~   "
65263|NCT02712723|"~     The purpose of this study is to determine if ribociclib in combination with letrozole for 24~     weeks as neoadjuvant endocrine therapy increases the proportion of women with Pre-operative~     Endocrine Prognostic Index (PEPI) score of 0 at surgery compared to patients treated with~     letrozole alone therefore allowing more patients excellent outcomes without chemotherapy.~   "
65264|NCT02712710|"~     The purpose of this study is to investigate the effect of functional knee brace in the~     subjects with medial compartment knee OA.~   "
65265|NCT02712697|"~     The present study was designed to identify the efficacy and safety of Integrative Medicine by~     joint oral steroid medicine on liver-kidney yin deficiency, severe IgA nephropathy.~     Furthermore, search for potential diagnostic predictor in IgA Nephropathy by Proteomics and~     Metabolomics.~   "
65266|NCT02712684|"~     In men who require a prostate biopsy does a multi-parametric ultrasound based diagnostic~     strategy compared to a multi-parametric MRI based diagnostic strategy lead to similar~     detection of clinically significant prostate cancer?~   "
65267|NCT02712671|"~     Human Immunodeficiency Virus (HIV) is the strongest individual risk factor for the~     reactivation of tuberculosis (TB) after previous exposure to Mycobacterium tuberculosis~     (MTb). This risk is reduced but not completely eliminated when HIV is treated with~     antiretroviral therapy (ART). Both the British HIV Association (BHIVA) and National Institute~     of Health and Care Excellence (NICE) suggest testing for latent TB infection in HIV infected~     individuals, but use different criteria. The cost -effectiveness of either approach has not~     been assessed, nor is testing widespread. A certain proportion of HIV infected subjects in~     Africa have MTb detectable in their sputum despite not having symptoms (such as cough or~     weight loss), nor changes on a chest x ray. It is unclear if this happens in lower TB~     prevalence areas such as the United Kingdom (UK). We intend to test a cohort of HIV infected~     subjects for evidence of latent TB using a tuberculin skin test (TST) and Interferon Gamma~     Release Assay (IGRA), ask about symptoms (using a standardised questionnaire) and to induce~     sputum using a saline nebuliser, to detect MTb using microscopy and culture, and newer~     nucleic acid amplification (genetic) techniques. Some patients, despite being exposed to TB~     in the past, will not mount a response using an IGRA or TST, which maybe due to an abnormal~     immune response. This lack of response seems more common in HIV. By investigating the number~     of patients with positive TST, IGRA, chest X ray and evidence of MTb in their sputum, in the~     context of place of birth, previous exposure to TB, CD4 count and other medications, we can~     assess the cost- effectiveness of systematic TB screening and the use anti-TB antibiotics to~     prevent reactivation of TB. In time, we will be able to answer important questions about the~     time taken to reactivate TB in individuals with HIV who do or don't take preventative anti-TB~     medications in the UK.~   "
65268|NCT02712658|"~     The aim of the study is to investigate the role of K+ and Ca2+ in development of muscle~     fatigue in trained young men.~   "
65269|NCT02712645|"~     This study is being performed to collect blood for the development of noninvasive tests that~     can screen for or diagnose cancer. Blood samples will be collected from women who are~     scheduled to have breast biopsies.~   "
65327|NCT02711891|"~     This study evaluates topical loperamide 5% gel in reducing pain during repeat finger lancing~     (finger stick) in healthy adults. Half of participants received 5% loperamide gel applied to~     their fingertip prior to their second lance and the other half received the gel only.~   "
65270|NCT02712632|"~     The GoDARTS study will encompass all patients, with diabetes, aged 16 and upwards who meet~     the planned inclusion criteria. The study aims to investigate biomarkers associated with~     diabetes progression, therapeutic response, diabetes complications and related traits, and~     specifically to investigate mechanisms of action and response to metformin. The study will~     specifically target patients who have been diagnosed within the past 2 years and follow up~     will be by linkage to electronic health record data. Up to 6,000 patients will be recruited~     into the study over a period of 2-3 years with a primary aim to identify 1000 of these~     patients who should be suitable to be started on metformin therapy.~      Most patients will undergo a single screening visit lasting approximately 20 minutes~     conducted on an outpatient basis. Patients commenced on metformin therapy will need to attend~     a second clinic visit to be carried out between 4-6 months after initiation of metformin~     therapy.~      Up to 9 health boards will be approached regarding participating in the study, and it is~     estimated that between 4-6 diabetes patients will be recruited into the study each week, at~     each site.~      All screened patients will provide consent for data linkage and longitudinal follow up and~     their samples and data will be used to supplement the SHARE/SDRN bioresource. The collection~     into the resource will be managed by the co-ordinating centre study team based at the~     University of Dundee/NHS Tayside. The resource will be hosted by the Tayside Biorepository~     and access to samples and data will be managed by the Tayside Biorepository on behalf of the~     whole of Scotland.~   "
65271|NCT02712619|"~     Two doses of metformin with 12 hour interval~        -  low dose group (375/250 mg)~        -  high dose group (1000/1000mg)~   "
65272|NCT02712606|"~     A study about accuracy of pulse oximeter with hypoxemic measurements (Blue sensor, Masimo,~     Irvine, CA, USA) in children with cyanotic congenital heart disease~   "
65273|NCT02712593|"~     This study will evaluate the effect of repeated doses of Niagen™ on Niagen™ metabolite~     concentrations in blood, urine and muscle. There will be 3 doses of Niagen™ compared to a~     placebo. One quarter of subjects will receive the low dose of Niagen™, one quarter will~     receive the moderate dose of Niagen™, one quarter will receive the higher dose of Niagen™ and~     one quarter will reveive the placebo.~   "
65274|NCT02712580|"~     This study will determine the effect of the wireless micro current stimulation in pediatric~     deep dermal burns and scald injuries. The clinical trial ist designed as a blinded,~     placebo-controlled, randomized, prospective, single-center study.~   "
65275|NCT02712567|"~     SARC021C is a nonrandomized, open-label, multicenter, continuation study designed to provide~     access to TH-302 for patients currently receiving and benefiting from single agent TH-302~     therapy as part of the Phase III TH-CR-406/SARC021 study.~   "
65276|NCT02712554|"~     The purpose of this study is to assess the abuse potential of CL-108 tablets, including the~     abuse deterrent effects of promethazine, following oral administration, relative to~     hydrocodone/acetaminophen (APAP) tablets and placebo in non-dependent, recreational opioid~     users.~   "
65277|NCT02712541|"~     The purpose of this study is to determine whether there is an association between adverse~     physical and/or psychological outcome in ICU survivors and the caregiver burden for their~     relatives.~      We hypothesize that relatives to ICU survivors with an incomplete physical and/or~     psychological recovery three months after ICU stay report a higher caregiver burden.~   "
65278|NCT02712528|"~     Backgrounds: Monitoring of Bispectral index (BIS) has been regarded as useful to determine~     the degree of intraoperative hypnosis. Major factors of postoperative recovery after cardiac~     surgery include patient's recovery in cognitive function from the postoperative residual~     effects of anesthetics, such as opioids and sedatives, administered during intraoperative~     period. Therefore employing anesthetic regimens which can provide earlier recovery in~     cognitive function would be beneficial in facilitating fast-track cardiac surgery with~     earlier postoperative extubation and discharge from the intensive care unit (ICU).~      Previous investigations suggested efficacy of BIS in evaluating the degree of postoperative~     hypnosis in the ICU.~      The present study compares the time for reaching BIS greater than 80 after using 2 different~     anesthesia regimens for cardiac surgery, remifentanil-based regimen and~     sevoflurane-sufentanil balanced regimen.~      Analyzing the changes immediately after cardiac surgery would be useful to determine the~     degree of patient's postoperative emergence.~      Materials and Methods:~      During study period, patients undergoing elective cardiac surgery in Konkuk University~     Medical Center are randomly assigned to get remifentanil-based regimen consisting of~     remifentanil 0.75 mcg/kg/min and supplemental propofol for maintaining BIS 40-60 (Group R) or~     sevoflurane (end-tidal 1.2-2.8 vol%) and sufentanil (0.015 mcg/kg/min) balanced regimen in~     Group S.~      All patients get intravenous patient controlled anesthesia consisting of alfentanyl and~     ondansetron after surgery. Supplemental remifentanil 0.25-0.3 mcg/kg/min is administered~     during postoperative 2 hours in Group R.~      As a primary objective, inter-group difference in the time for achieving BIS greater than 80~     is determined.~   "
65279|NCT02712515|"~     Essential tremor (ET) is among the most common movement disorders, and is the most prevalent~     tremor disorder. It is a progressive, degenerative brain disorder that results in~     increasingly debilitating tremor, and afflicts an estimated 7 million people in the US (2.2%~     of the population) and estimates from population studies worldwide range from 0.4% to 6.3%.~     ET is directly linked to progressive functional impairment, social embarrassment, and even~     depression. Intention (kinetic) tremor of the arms occurs in approximately half of ET~     patients, and is typically a slow tremor (~5-10Hz) that occurs at the end of a purposeful~     movement, and is insidiously progressive over many years. Based on direct and indirect~     neurophysiological studies, it has been suggested that a pathological synchronous oscillation~     in a neuronal network involving the ventral intermediate nucleus (Vim) of the thalamus, the~     premotor (PM), primary motor (M1) cortices, and the cerebellum, may result in the production~     of ET. In spite of the numerous therapeutic modalities available, 65% of those suffering from~     upper limb tremor report serious difficulties during their daily lives. Deep brain~     stimulation (DBS) has emerged as an effective treatment option for those suffering from~     medically refractory ET. The accepted target for ET DBS therapy is the Vim thalamus. Vim~     projects to PM, M1, and supplementary motor areas (SMA) and receives afferents from the~     ipsilateral cerebellum. Moreover, electrophysiological recordings from Vim during~     stereotactic surgery have identified tremor cells that synchronously discharge with~     oscillatory muscle activity during tremor. Clinical and computational findings indicate that~     DBS suppresses tremor by masking these burst driver inputs to the thalamus. The overall~     goal is to investigate the neural signatures of tremor generation in the thalamocortical~     network by recording data during DBS implantation surgery. Investigators will record data~     from the macroelectrode implanted in the Vim for DBS therapy, and through an additional~     6-contact subdural cortical strip that will be placed on the hand motor cortical area~     temporarily through the same burr hole opened for the implantation of the DBS electrode.~   "
76374|NCT02567305|"~     This study is designed to assess the role of neutrophil extracellular traps (NETs) in~     neonatal and pediatric sepsis as well as to evaluate markers of NETs formation as early~     predictors of neonatal and pediatric sepsis.~   "
65280|NCT02712502|"~     Inflammatory paranasal diseases are among the most common diseases in ENT In Russia, puncture~     method has been conventional approach to treatment of maxillary sinusitis. However, this~     procedure is associated with a number of drawbacks A promising trend for the treatment of~     purulent sinusitis is a reasonable antibacterial therapy Fluoroquinolones, particularly~     levofloxacin, are highly active against pneumonocci and are more active vs. the drug products~     of the second generation against intracellular agents (Chlamydia spp., Mycoplasma spp., M.~     tuberculosis, rapidly growing atypical mycobacteria (M. avium, etc.).~      Due to high activity against the agents causing bacterial upper and lower respiratory tract~     infections they are sometimes called respiratory fluoroquinolones~   "
65281|NCT02712489|"~     A roll-over observational study (ISS T-003 EF-UP) is being conducted to extend the follow-up~     of the volunteers of the ISS T-003 trial in order to evaluate the persistence of vaccine~     immunogenicity as well as of the immunological and virological effects induced by the~     therapeutic immunization with Tat.~   "
65282|NCT02712476|"~     Although mannitol is used for brain relaxation during neurosurgery and in the treatment of~     raised intracranial pressure; there is not a consensus on its safe and effective dose, the~     duration of its administration and its use in combination with loop diuretics. This study~     aimed to compare the effects of the mannitol alone and in combination with furosemide in~     different doses, on the brain relaxation, electrolyte, lactate levels of the blood,~     peroperative fluid balance and the volume of the urine in supratentorial mass resection~     surgeries.~      This prospective, randomized, double blind, placebo controlled study included fifty one~     patients (ASA I-III) scheduled for elective supratentorial mass resection surgery. The~     patients were randomized into three groups for investigation of the effects of mannitol alone~     and in combination with furosemide in different doses. Blood sodium, potassium, chlorine,~     lactate, urine and osmolarity levels were recorded. The brain relaxation score (BRS) was~     evaluated twice by the surgeon using a 4 point scale (1=very good, 2=good, 3=bad, 4=very~     bad); at dura opening, and 30 minutes after the administration of the study drug.~   "
65283|NCT02712463|"~     The primary purpose of the study is to compare the rate of hospitalization associated with~     psychotic relapse in participants with schizophrenia treated one year before with oral~     antipsychotics and one year after with long acting injectable atypical antipsychotics.~   "
65284|NCT02712450|"~     According to surveys, 13% to 20% of the Service Médical d'Urgence (SAMU) centre 15 (French~     911) calls concern elderly patients above 75 years of age. For these patients, the clinical~     pathway should be decided on the basis of the symptomatology described during the call, but~     also with the gathering of specific data such as medical social and psychological evaluation.~     These items allow the regulating doctor to assess comorbidity, on-going treatment,~     psycho-cognitive status, previous hospitalisations, social situation, and patient~     expectations and needs.~      However, data collected in order to assess the situation on the phone and take the~     orientation decision are mainly limited to the severity of clinical symptoms. Medical,~     psychological and social aspects are rarely gathered, for several reasons :~        -  Phone call shortness : emergency calls should be treated quickly~        -  Regulating doctors are not trained to take in account the specificities or geriatric~          patients in their decision making. Besides, they are not informed about alternatives to~          the hospital emergency department, such as geriatric channel system.~      An observational study was performed in 2012 on 692 calls about elderly patients referred to~     the SAMU centre 15 during 7 days : 63% of these patients were transferred to an emergency~     department. Regardless of severe cases hospital regulation, 55% of the least serious cases~     (liberal regulation) were transferred to an emergency department.~      Regulation is inadequate to elderly patients for whom 1) the situation assessment and the~     appropriate decision making require specific items that are not known by regulating doctors,~     2) the medical care and the clinical pathway could be improved by the knowledge of on-field~     geriatric channel, 3) the emergency department care is particularly long, 4) and could be~     pernicious to younger patients.~      1920 patients will be recruited between January 2016 and August 2017, including a 6 months~     wash-out in order to train regulating doctors. This training will include geriatric patient's~     specificities, and geriatric channels. A 12% difference between the 2 groups (before and~     after the training) is expected, considering a 80% statistical power. The design is a time~     series experiment.~   "
65285|NCT02712437|"~     Women with early stage breast cancer may experience difficulty falling asleep or staying~     asleep. If this occurs for more than 4 weeks, these participants may have chronic insomnia.~     Chronic insomnia can lead to difficulty coping with stress, changes in mood, increased use of~     medications for sleep and an overall decrease in quality of life.~      The investigators have developed an internet-based website that is designed to help people~     manage symptoms typically experienced by breast cancer survivors, including insomnia,~     fatigue, pain and overall poor quality of life. The investigators want to learn whether this~     type of treatment can reduce chronic insomnia and improve the way subjects feel using both~     questionnaires and a special form of a wrist watch. This information may help the~     investigators better manage sleep difficulties in subjects who experience these symptoms~     after diagnosis of their breast cancer.~   "
65286|NCT02712424|"~     DAR-901 booster vaccine or placebo will be administered to adolescents in Tanzania primed~     with BCG to determine if immunization reduces the risk of TB infection~   "
65287|NCT02712411|"~     To investigate the pharmacokinetic properties and safety after administration of HCP1303 and~     co-administration of HGP1201, HIP1402 in healthy male volunteers~   "
65288|NCT02712398|"~     The objective of this study is to collect additional data on safety, performance and~     effectiveness of Phasix™ ST in subjects receiving laparoscopic ventral or incisional hernia~     repair at high risk for surgical site occurrence (SSO).~   "
65289|NCT02712385|"~     BACKGROUND - Approximately 1,700 transient ischaemic attacks (TIAs) occur annually in NI with~     TIA survivors often being left with considerable functional impairment. TIA and strokes share~     common risk factors with cardiovascular disease. Cardiac rehabilitation post-myocardial~     infarction has shown significant reductions in morbidity and mortality, with home-based~     programmes producing better adherence and similar outcomes to hospital-and community-based~     programmes. However, the value of rehabilitation programmes for stroke prevention following a~     TIA or minor stroke is unclear.~      AIMS - to determine if a novel rehabilitation programme, 'The Healthy Brain Rehabilitation~     Manual', for TIA/minor stroke patients can be developed, using MRC guidelines for developing~     complex health service interventions, from an approved home-based cardiac rehabilitation~     programme (the 'Heart Manual') and to undertake feasibility and pilot studies of the novel~     programme.~      METHODS-All patients attending a TIA clinic in Belfast within 4 weeks of their first TIA/mild~     stroke will be invited to participate. The novel home-based programme manual will be~     developed following systematic reviews of the literature and qualitative exploration with the~     target population, using focus groups. A feasibility study will initially be undertaken~     lasting 6 weeks and then developed into a pilot trial of 12 weeks duration. The feasibility~     will recruit to 3 different treatments: (1) standard care; (2) standard care plus the manual;~     (3) standard care, manual plus a pedometer. Whilst for the pilot study there will also be 3~     arms but this will include: 1) control group; 2) manual and pedometer supported by telephone~     follow-up with a GP; 3) manual and pedometer supported by telephone follow-up with a stroke~     nurse. Interviews and focus groups will be employed to assess the interventions'~     acceptability. The intervention, 'The Healthy Brain Rehabilitation Manual' will be refined~     and modified at all stages of the research.~      CONCLUSIONS - The findings will inform the development of a novel secondary prevention~     programme, 'The Healthy Brain Rehabilitation Manual', for TIA/minor stroke patients and of a~     trial to test its effectiveness and longer-term potential to improve outcomes for TIA/stroke~     patients.~   "
65290|NCT02712372|"~     This is a Phase I, first-in-human (FIH) study to assess the safety, tolerability,~     pharmacokinetics (PK) and Pharmacodynamics (PD) of AZD4831 after single and multiple~     ascending doses in healthy male subjects~   "
65294|NCT02712320|"~     This is a safety extension of up to 12 months of additional treatment with LMIS 50 mg after~     the subject has completed 12 months of treatment under Protocol FP01C-13-001 and remain~     eligible for continued treatment with androgen deprivation therapy. Subjects participating in~     Protocol FP01C-13-001-EX will be followed for safety only.~   "
65295|NCT02712307|"~     The primary objective of the study is to compare the clinical efficacy of 5 days (800 mg x 4)~     versus 10 days (1000 mg x 3) treatment with phenoxymethylpenicillin (PcV) in adults,~     adolescents and children with streptococcal tonsillitis. Patients are recruited from 17~     primary Health care centres in the south of Sweden. Adult men and women, youth and children ≥~     6 years of age who are visiting the primary Health care for sore throat with suspected~     tonsillitis and meeting the criteria in accordance with current treatment recommendations for~     pharyngotonsillitis, ie 3-4 Centor criteria (fever≥ 38.5, tender lymph nodes, coatings of the~     tonsils and absence of cough) and a positive rapid antigen detection test (RADT) for Group A~     streptococcus (GAS) will be included in the study. Patients will be randomized to be~     prescribed PcV of 5 and 10 days. Each patient or guardian fills daily in a short diary~     including aches, fever, PcV doses, pain relievers, adverse events etc. Five to seven days~     after last intake of PcV the general practioner make a clinical judgement if the patient has~     recovered from the pharyngotonsillitis. Questions to be asked are if remaining symptoms or~     new symptoms of sore throat is present, if adverse events have been noted or of any extra~     physician visits have been made. Throat swab for semi quantitative cultures of Streptococcus~     group A, C and G are made at randomization and five to seven days after last intake of PcV. A~     study nurse will contact the patients one month and three months after the last treatment day~     for follow-up. If the patient has reconsulted or been hospitalised for a sore throat or~     possible complication, those patient records will be examined.~   "
65296|NCT02712294|"~     Pulmonary hypertension (PH) features symptoms related to a decreased cardiac autonomic~     response, pulmonary function and exercise capacity.~      Non-pharmacological interventions are low cost and can significant enhance outcomes in these~     patients. Neuromuscular electrical stimulation (NMES) has been proposed as a viable~     therapeutic approach in patients with functional limitations, particularly those that present~     with difficulty to perform exercise protocols.~      Objective: to evaluate the impact of NMES on exercise capacity, spirometry values and quality~     of life of patients with PH.~      Material and methods: prospective randomized controlled study with a control group (GC, n9)~     and NMES goup (GE, n8). Quality of life and exercise capacity through the six-minute walk~     test (6MWT) were assessed before and after the NMES protocol.~      Results: the GE presented with a significant improvement in distance walked in the 6MWT,~     cycle ergometry, spirometry and quality of life in the areas of vitality, emotional and~     social aspects of the questionnaire Short Form Health Survey-36.~      Conclusion: NMES is a useful tool in the treatment of patients with PH, resulting in improved~     exercise capacity, quality of life and lung function testing.~   "
65297|NCT02712281|"~     The Autism Managing Eating Aversions and Limited variety (MEAL) Plan is a group-based parent~     training intervention designed to assist parents in increasing the variety of foods eaten in~     children with Autism Spectrum Disorder (ASD). The goal of the Autism MEAL Plan is to include~     specific techniques to manage mealtime behavioral challenges and introduce new foods.~   "
65298|NCT02712268|"~     This study tested the efficacy of an easy-to-use checklist aimed at supporting the~     therapeutic reasoning of physicians in order to reduce inappropriate prescribing and~     polypharmacy in elderly adults admitted to an internal medicine unit.~   "
65299|NCT02712255|"~     THE AIMS: The project aims at investigating of the effects of three types of planning~     (individual planning, collaborative planning, and dyadic planning) on physical activity.The~     influence of three planning interventions are compared with an active control condition,~     including physical activity education. PARTICIPANTS: The effects of the interventions are~     evaluated among dyads of patient and his/her partner. The patients with physical~     activity-related chronic diseases (cerebrovascular diseases or diabetes) will be enrolled. A~     minimum of 50 dyads enrolled into the each arm of the trial (a total of 200 dyads). The~     interventions consist of six planning sessions.~      DESIGN: The dyads are randomly assigned to one of four experimental conditions. The~     assessment of the main and secondary outcomes is conducted at the baseline, at 1 week after~     the first intervention session, at post-intervention (after six intervention sessions are~     completed), and at 6-, and 12-month follow-ups.~      OUTCOMES: Physical activity constitutes the main outcome, whereas health-related quality of~     life (HRQOL), body mass index, as well as the self-regulatory strategy called the use of~     planning (individual, dyadic and collaborative) are secondary outcomes.~   "
65300|NCT02712242|"~     Backgroung: Various agents are used to reduce post-operative complications associated with~     palatal donor site surgery for free gingival graft (FGG) harvesting. This study was conducted~     to evaluate the effects of platelet-rich fibrin (PRF) on palatal wound healing.~   "
65301|NCT02712229|"~     The overall goal of this study is to test whether a nurse-led intervention to improve~     provision of primary palliative care within oncology practices (CONNECT) can decrease~     morbidity for patients with advanced cancer and their caregivers.~      The specific aims are to:~      Aim 1. Assess the effects of CONNECT on patient quality of life (primary outcome), symptom~     burden, and mood at 3-month follow-up.~      Aim 2. Assess the effects of CONNECT on caregiver burden and mood at 3-month follow-up.~      Aim 3. Assess the effects of CONNECT on healthcare resource use over 1 year of follow-up.~   "
65302|NCT02712216|"~     The purpose of this research study is to determine which sites are best suited for~     laparoscopic entry of bariatric trocars in the morbidly obese population.~   "
65303|NCT02712203|"~     Healthy children who received two doses of GlaxoSmithKline (GSK) Biologicals' live attenuated~     measles-mumps-rubella vaccine (MMR) or measles-mumps-rubella-varicella vaccine (MMRV) in~     their second year of life.The purpose of this study is to assess the effect of the age at~     administration of the first dose on the reactogenicity and immunogenicity of the measles~     component of these vaccines.~      In addition, this study will evaluate if the effect of the age at first dose is modified by~     the type of vaccine administered.~   "
65304|NCT02712190|"~     The purpose of the study is to assess the efficacy of high-frequency non-invasive ventilation~     on apnea duration, carbon dioxide clearance and oxygen delivery in healthy subjets and~     patients with lung disease.~   "
65305|NCT02712177|"~     Bexsero™ is a four component serogroup B meningococcal vaccine (4CMenB) licensed in Europe,~     Canada, and Australia in 2014. Prelicensure studies and post marketing surveillance data~     showed that 4CMenB has a high reactogenicity especially when coadministered with other infant~     routine vaccines [1-2]. While this suggests that coadministration causes an interaction~     resulting in a greater risk of adverse events following Immunization (AEFI) only the AEFI~     after the 4CMenB dose and not those occurring after routine vaccine immunizations were~     reported, underestimating the total risk associated with immunization at separate visits. For~     financial and practical reasons, coadministration of infant vaccines is preferred to separate~     visits. Separate visits may however be preferred if the sum of the AEFI risk at each visit is~     significantly smaller than the risk with coadministration and/or if the AEFI has a lesser~     severity. The purpose of this study is to recalculate the risk of occurrence and severity of~     AEFI with the coadministration of Bexsero™ and routine vaccines compared to separate~     injections to assess the interaction occurring with co-administration. Investigators will~     also estimate the risk of recurrence of AEFI at subsequent immunizations with the 4CMenB and~     assess if this risk varies with separate or coadministration with routine vaccines. To~     achieve these purposes, investigators will perform a secondary analysis of the data of three~     randomized controlled trials (clinicaltrials.gov identifiers: NCT00657709, NCT00847145 and~     NCT00721396) that evaluated 5025 children aged 2 to 14 months of whom 4535 were randomized to~     receive 3 to 4 doses of 4CMenB concomitantly or alternatively with routine vaccinations~     (DTaP-IPV-HepB/Hib [Infanrix Hexa™], PCV7 [Prevenar™] or MMRV [Priorix-Tetra™]) [1,2].~   "
65306|NCT02712164|"~     The purpose of this single-center, randomized, prospective cohort study is to evaluate the~     clinical outcome and negative-pressure wound therapy (NPWT) mediated modulation of the~     biologic milieu of a modified NPWT dressing on split-thickness skin graft (STSG) donor sites.~   "
65307|NCT02712151|"~     Laparoscopic cholecystectomy is associated with considerable postoperative pain and~     surgeon-administered local anesthetic infiltration is the standard practice for achieving~     post-operative analgesia. However, recent studies have shown that pediatric patients continue~     to experience significant pain during the first 24 hours.~      The investigators plan to conduct a prospective, double-blinded, randomized study where~     patients will be designated into either a test group receiving an ultrasound-guided~     transversus abdominis plane (TAP) and rectus sheath (RS) blocks with ropivacaine and~     peri-portal sterile saline or the control group that will receive ultrasound-guided TAP block~     with sterile saline and peri-portal infiltration of ropivacaine. The anesthesia team and~     surgical team will both be blinded as well as the research personal in the postoperative~     period. Patients age 5-17 and American Society of Anesthesiology status I and II undergoing~     laparoscopic cholecystectomy will be included.~      The study hypothesis is that ultrasound-guided peripheral nerve blocks, specifically single~     shot transversus abdominis plane and rectus sheath blocks, are superior to local wound~     infiltration during laparoscopic cholecystectomy for decreasing postoperative pain and pain~     related behavior and facilitating functional recovery.~   "
65308|NCT02712138|"~     Development of a new mass spectrometry based biomarker for the early and sensitive diagnosis~     of a Gilbert disease from plasma. Testing for clinical robustness, specificity and long-term~     stability of the biomarker.~   "
65309|NCT02712125|"~     Objective: To assess the influence of maternal isosorbide mononitrate (IMN) vaginal~     supplementation in improving liquor volume in women with isolated oligohydramnios.~      Study Design: Prospective randomized interventional study. Materials and Methods: 100 women~     with singleton pregnancy about 28-36 weeks, with isolated oligohydramnios [amniotic fluid~     index (AFI) < 5] were enrolled in the study. Before the proposed intervention, the antenatal~     risk factors were studied. Patients received 20 mg isosorbide mononitrate (IMN) vaginally.~     Patient were followed after 24 hours then weekly. The treatment was continued till the liquor~     improved significantly or until delivery. Outcome measures; mean increase in liquor,~     intervention delivery interval, and neonatal outcome were studied.~   "
65310|NCT02712112|"~     Recent preclinical study has suggested a potential possibility that imatinib might promote~     tumor growth in the presence of secondary resistance mutations [10]. This result imply that~     intermittent dosing schedule of imatinib rechallenge might be better than continuous dosing~     schedule in terms of controlling tumors harboring secondary resistance mutations. In~     addition, in these heavily pretreated patients, even mild grade of toxicity may significantly~     impair quality of life, and intermittent dosing schedule may have an advantage in this~     context. Therefore, investigators hypothesize that intermittent dosing schedule of imatinib~     rechallenge might be feasible and effective in patients with TKI-refractory GISTs. This study~     will assess the feasibility of intermittent imatinib dosing schedule in patients with GISTs~     who had failures from both imatinib and sunitinib.~   "
65311|NCT02712099|"~     The purpose of this study is to evaluate the potential of the 3 D TUI view in diagnosis of~     morbidly adherent placenta in comparison to 2D grayscale, color Doppler and intraoperative~     findings.~   "
65312|NCT02712086|"~     The main objective will be to evaluate the effect at 5 weeks of nutritional management~     associated with protein supplementation (adapted to the post-operative period) on the~     maintenance of lean body mass at the whole body in obese patients after a sleeve gastrectomy.~      Secondary objectives will assess protein intake, food safety, the effect of protein~     supplementation on body fat in the entire body and the metabolic rate and the impact on~     quality of life and post-operative joint pain.~   "
65313|NCT02712073|"~     In France, nearly 1.3 million colonoscopies are performed each year. Colonoscopy is the gold~     standard in France for colorectal cancer screening in populations at risk. However, it has a~     number of limitations. The quality of the bowel preparation is a critical step for the~     successful completion of this examination. The occurrence of interval cancers raises the~     problem of missed lesions. A literature review showed that there were differences between the~     endoscopy units on quality standards for bowel preparation. The rate of unprepared~     colonoscopy is estimated between 20 to 40% . In a recent cohort study, 28% of 2516~     colonoscopies had a score of Boston of less than or equal to 6. These colonoscopies generate~     substantial additional costs to redo colonoscopies, estimated at 35 million euros in 2008.~     The establishment a predictive score for quality of bowel preparation based on a~     self-administered questionnaire completed by patients during the pre-colonoscopy~     consultation, would help identify patients at risk of poor preparation in order to optimize~     the prescribed preparation in this consultation.~   "
65314|NCT02712060|"~     Ehlers-Danlos Syndrome (EDS) is a clinically and genetically heterogeneous group of inherited~     connective tissue disorders characterized by joint hypermobility, skin hyperextensibility,~     and tissue fragility. EDS features such as genetically related cartilage defects,~     craniofacial abnormalities and increased pharyngeal collapsibility have been proposed to~     cause obstructive sleep apnoea (OSA). There is evidence from studies based on questionnaires~     that EDS patients might be more frequently affected by OSA and sleep disturbances than the~     general population. However, the actual prevalence of OSA in children and adolescents with~     EDS is unknown.~      The primary objective of this study is to assess the prevalence of OSA in children and~     adolescents with EDS (25) compared to a matched control group (25). The secondary objective~     of this pioneer study is to assess the quality of life in children and adolescents in EDS in~     comparison to healthy children and adolescents.~   "
65315|NCT02712047|"~     For asthmatic subjects, a combination of inhaled corticosteroid (FF) and long-acting beta2~     receptor agonist (VI) is recommended for use (once daily) and fraction of exhaled nitric~     oxide (FeNO) is a non-invasive airway inflammation marker.~      In this randomised, double blind, placebo-controlled, two-period, crossover repeat dose~     study, the duration of action of fluticasone furoate (FF) will be determined by monitoring~     the return of FeNO levels to baseline, following the treatment with FF/vilanetrol (VI) in~     asthmatic subjects.~      Subjects who meet the eligibility criteria will participate in the following two treatment~     periods: FF/VI 100/25 mcg once-daily and placebo once-daily. Approximately 28 subjects will~     be enrolled in order to achieve 24 evaluable subjects. A 2-week treatment period will be~     followed by a 21-day monitoring/washout period before crossing over to the next treatment~     period. Total duration of each subject will be a maximum of 21 weeks. FeNO will be monitored~     up to 21 days after treatment with FF/VI together with FEV1 (up to 7 days).~   "
65316|NCT02712034|"~     The primary aim of this study is to measure and explain the impact on long-term opioid use~     when medication-assisted treatment (MAT) is bundled with an evidence-based mobile-health~     system (A-CHESS).~   "
65317|NCT02712021|"~     Lycra garments have recently been used for children with cerebral palsy, with favorable~     effects on alignment, biomechanics and neuromuscular activity. The aim of the present study~     is to determine the efficacy of a Lycra suit in improving motor function and static balance~     in children with cerebral palsy. The children included in this study will be part of a~     prospective project on children with cerebral palsy, older than 4 years of age, and their~     families regularly followed at the Child Neurology Unit of the Catholic University of Rome.~   "
65318|NCT02712008|"~     The primary objective of the study is to compare the efficacy of intravitreal~     (IVT)-administered REGN910-3 compared to intravitreal aflibercept injection (IAI) in~     improving best corrected visual acuity (BCVA) in patients with diabetic macular edema (DME).~   "
65319|NCT02711995|"~     Botulinum toxin is the common treatment of choice for patients with Essential Voice Tremor~     (EVT), but results are not universally beneficial to all patients. Inconsistent results are~     noted in the literature and are consistent with the PI's clinical experience. Injection~     augmentation, a well-established treatment for glottic insufficiency, which is a prominent~     factor in the clinical presentation of Essential Voice Tremor (EVT), has not been studied. By~     treating patients at separate times with botulinum toxin and injection augmentation in an~     unblinded prospective crossover treatment study, we can assess functional outcomes of these~     two treatments with the population of patients with Essential Voice Tremor (EVT).~   "
65320|NCT02711982|"~     The pathophysiology of Traumatic Optic Neuropathy (TON) include a primary and secondary~     mechanism of injury. At present, no studies validate a particular approach to the management~     of TON. There are three management lines for these patients that include 1)observation~     only;2)medical treatment with high or megadoses of methylprednisolone; and 3)surgical~     intervention. Studies have shown that forces applied to the frontal bone and malar eminences~     are transferred and concentrated in the area near the optic canal. The tight adherence of the~     optic nerve's dural sheath to the periosteum within the optic canal is also thought to~     contribute to this segment of the nerve being extremely susceptible to the deformative~     stresses of the skull bones. In this study, investigators aim to make a randomized controlled~     trial to certify the efficiency of optic nerve canal decompression for TON patients.~   "
65321|NCT02711969|"~     An open study to evaluate the safety of apatinib mesylate (YN968D1) 1,000mg monotherapy in~     patients with unresectable locally advanced or metastatic Gastric cancer failed to standard~     therapy.~   "
65322|NCT02711956|"~     This is an open label, non-randomized, Phase 1b/2a, dose escalation and dose confirmation~     study of ZEN003694 in combination with enzalutamide in patients with mCRPC.~   "
65323|NCT02711943|"~     Chronic prostatitis is a common disease in men with the following typical symptoms decreasing~     the ability to work and quality of life: pain, urination disorders, copulatory dysfunction.~      Following study is conducted to study Levofloxacin in chronic prostatitis.~   "
65324|NCT02711930|"~     Acute respiratory distress syndrome (ARDS) commonly complicates acute illness in intensive~     care units (ICU). This syndrome is associated with high morbidity and mortality. In~     management of ARDS patients, lung protective ventilation and prone ventilation are key~     strategies which have shown survival benefits in recent years and now become standard part of~     care in these patient. Prone positioning used for surgeries in operation room has been~     reported with ocular complications, of which vision loss is one of the devastating~     complications. There is scarcity of literature on effect of prone positioning on intra-ocular~     pressure (IOP) in critically ill patients. The purpose of our study is to evaluate the effect~     of prone position on IOP in critically ill patients and follow up for other ocular~     complication among survivors.~   "
65325|NCT02711917|"~     Different concentration of sevoflurane was given to maintain anesthesia. The dose of propofol~     to maintain BIS between 40-60 and the consumption of rocuronium was recorded and evaluated.~   "
65326|NCT02711904|"~     Condition of the State: (terminated, recruiting, etc.) Terminated~      Study Design: Main Objective:~      Compare the frequency and intensity of coughing at the time of extubation with two infusions~     of remifentanil that predict a plasma concentration (PC) of 3 - 4 and 2 - 3 ng/ml, through~     the technique of target controlled anesthesia~   "
65348|NCT02711618|"~     Prospective, one arm, baseline-controlled clinical study for the evaluation of UltraShape~     contour I V3 for non-invasive fat reduction.~      The study will conduct using the UltraShape contour I V3 using U-Sculpt/VDF transducer on the~     abdomen.~   "
65328|NCT02711878|"~     The purpose of this study is to see if exercise is helpful for improving memory,~     concentration thinking abilities, physical function, and quality of life for adults aged 50~     to 89 years living with HIV and who have two or more cardiovascular disease risk factors. The~     study will test two kinds of intervention exercises: one group will walk for exercise and the~     second group will stretch for exercise. Members of both interventions will be asked to~     participate in one-on-one interviews/assessments, measures of physical functioning, and some~     sessions with others who are also enrolled in the study.~   "
65329|NCT02711865|"~     The main goal of this study is to employ a novel proteomic approach to identify predictive~     tumor biomarkers that will increase the efficacy of insulin-like growth factor (IGF1R)~     targeted therapy in epithelial ovarian cancer. It is expected that these predictive~     biomarkers will be applied to increase the response rate in selected groups of patients.~   "
65330|NCT02711852|"~     This long-term, continued treatment study will evaluate the long-term safety of duvelisib in~     patients with hematologic malignancies that were previously treated with duvelisib in a~     previous sponsor-approved study.~   "
65331|NCT02711839|"~     In order to response the increasing of aging population cause losing ability that need~     long-care needs, the project entitled 10-year long-term care program from Executive Yuan in~     2007 is carried out to assist economically disadvantaged and disabled elderly to acquire~     daily nutrition. Therefore, the long-term care resident's nutritional status got more~     attention than before. Out of control in blood glucose will not only increase bed sores and~     urinary tract infection in tube feeding residents but also rise medical expenditures. The~     nutritional status of long-term care institutions, anyang homes and nursing home are~     generally bad in nutrition management due to high cost of nutritional supplements from~     foreign imports that cause the burden of families. In this study, we will recruit diabetic~     subjects that divide into white sweet potato group (experimental group) and commercial~     formula group (control group) by using randomized, parallel and open clinical study through~     tube feeding in sixty days.~   "
65332|NCT02711826|"~     The purpose of this study is:~        -  To see if polyTregs and/or donor reactive darTregs can reduce inflammation in a~          transplanted kidney.~        -  To find out what effects, good or bad, polyTregs or darTregs will have in the kidney~          recipient.~        -  To find out what effects, good or bad, taking everolimus after polyTregs or darTregs~          will have in the kidney recipient.~   "
65333|NCT02711813|"~     The purpose of this study is to assess whether TAB08 may be beneficial compared to placebo in~     patients with active Systemic Lupus Erythematosus, not adequately controlled with current~     concomitant treatment. Secondary purpose is to assess efficacy, safety, pharmacokinetic and~     pharmacodynamic parameters in this study population.~   "
65334|NCT02711800|"~     The investigators seek to conduct the first open-label trial of probiotics in young children~     to reduce their anxiety and abdominal pain. Likewise, the investigators aim to assess the~     feasibility and efficacy of this treatment and to elucidate the enteric microbiota in the~     middle-lower GI tract. Self-report measures and a laboratory task will be collected from~     children, ages 9-13 years of age, and self-report measures from their primary caregivers~     prior to and following a 30-day probiotic administration. Children who score above cutoff in~     anxiety and/or abdominal pain meet the inclusion criteria for this study. Because of limited~     sample size and the iterative nature of intervention development, criteria for success at the~     pilot phase are based primarily on clinical rather than statistical criteria. The study~     personnel will do their best to keep and ensure the privacy and confidentiality of our~     participants; however, some of the risks of this study may include psychological discomfort,~     legal risks, and loss of confidentially.~   "
65335|NCT02711787|"~     Among robotic devices, Gloreha, with its compliant mechanical transmission, may represent an~     easily applied innovative solution to rehabilitation, because the hand can perform grasp and~     release activities wearing the device by mean of a flexible and light orthosis. Our objective~     on this research was to the robotic assisted motion and activity in additional to~     physiotherapy (PT) and occupational therapy (OT), on stroke patients with hand paralysis.~   "
65336|NCT02711774|"~     Intracranial Pressure ( ICP ) monitoring is an essential component of traumatic brain injured~     ( TBI ) patients management. The clinical signs of raised ICP may be unreliable and may~     reflect relatively late cerebral decompensation. ICP may be monitored by invasive or non~     invasive techniques. While invasive techniques show the real time values of ICP, they are~     associated with many complications like, intracranial bleeding and infection, occlusion of~     the catheter tip by blood, debris and difficult to locate ventricle in presence of cerebral~     oedema. All these drawbacks of invasive methods can be averted by employing non invasive~     techniques of ICP monitoring. Although they do not show a real time value but are excellent~     tools to detect presence or absence of raised ICP. Elevated ICP can be detected by~     Computarised tomographic scan (CT) or Magnetic resonance imaging (MRI) but , these techniques~     are time consuming and require transportation of a patients who may be unstable .The quick~     and non invasive nature of ultrasonography is fast becoming popular for rapid detection of~     elevated ICP at bedside in emergency and ICU by monitoring the optic nerve sheath diameter (~     ONSD ). Its limitations notwithstanding, ultrasonographic ONSD monitoring is likely to be~     more reliable than clinical assessment in the diagnosis of intracranial hypertension~     especially, when patient is under sedation which precludes proper clinical examination.~     Therefore, in recent years ,among non invasive methods, bedside ocular ultrasonography to~     monitor ICP has gained popularity.~      Carbon dioxide being a potent modulator of cerebral vascular tone, alters the ICP by changing~     the size of cerebral vasculature and thereby, cerebral blood flow (CBF) and this action~     occurs very rapidly, over e period of few minutes. In a range of PaCO2 20mmHg to 80 mmHg the~     cerebral blood flow changes in a linear manner. End tidal carbon dioxide concentration(EtCO2)~     is a surrogate measure of PaCO2 (especially in a haemodyanimically stable patient with~     healthy lungs ) and is routinely monitored continuously in patients subjected to general~     anaesthesia. To date there is very little literature on the effects changing EtCO2 on ONSD .~     This prompted us to conduct this study to find out the effects of different levels of EtCO2~     on ONSD.~   "
65337|NCT02711761|"~     prospective randomized double-blind controlled study~   "
65338|NCT02711748|"~     The study aims to assess the regularity of the proceedings in the case of a patient with~     bradycardia ECG.~   "
65339|NCT02711735|"~     Prospective, randomized, double-blind, multicentre, placebo-controlled clinical phase IIa~     trial to evaluate safety and immunogenicity of RUTI® vaccine in Multidrug-resistant~     Tuberculosis (MDR-TB) patients favourably responding to standard MDR-TB treatment. Time point~     of vaccination starts at 16 weeks upon start of standard MDR-TB treatment (cohort A), and if~     clinically safe as evaluated by an independent panel of experts (DSMB), another cohort of~     patients will be vaccinated at 12 weeks upon start of standard MDR-TB treatment (cohort B).~     All the patients will be followed up 8 weeks after vaccination.~   "
65349|NCT02711605|"~     Male volunteers who suffer from Pseudogynecomastia and seek noninvasive breast fat reduction~     will be enrolled into two arms to receive three biweekly UltraShape treatments.~   "
65340|NCT02711722|"~     Title: Reduced Unloading in NAVA Improves distribution of Ventilation in ICU patients.~      Objectives:~        1. To investigate if NAVA targeted to moderate respiratory muscular unloading results in~          redistribution of ventilation to the dorsal regions of the lungs~        2. To verify if the redistribution of ventilation translates to a better gas exchange and~          to a potentially lung protective ventilation strategy (lower airway pressures)~        3. To verify the possibility to set NAVA at different levels of unloading, based on~          Neuro-Ventilatory Efficiency.~      Study Design: Randomised Crossover of Pressure Support and NAVA at different levels of~     unloading.~      Population: Adult Intubated patients at the Neurosurgical ICU, ventilated for more than 48h,~     in weaning phase from mechanical ventilation.~      Study duration: 2,5h Number of subjects: 12~   "
65341|NCT02711709|"~     The purpose of this study is to define the natural history and causes of chronic critical~     illness (CCI) in surgical intensive care patients who have had sepsis. The investigator wants~     to study a sub-population of sepsis patients that have intra-abdominal sepsis. The purpose of~     this research study is to define the acute changes in frailty (weakness, slowness, loss of~     muscle mass), comorbidity (medical problems) and disability (difficulty with mobility and~     performing routine daily functions) after having an infection that is located in the~     abdominal cavity or torso. The investigator believes having severe infection contributes to~     acute and permanent changes in these areas, especially in those of advanced age.~   "
65342|NCT02711696|"~     The study assessed whether compete healing of duodenal mucosa in celiac patients with~     persistent Marsh I-II lesion after 1 year of gluten free diet (GFD):~        -  could be achieved by adoption of a diet based exclusively on naturally gluten free~          products, with the elimination of commercially available processed food (GCED, Gluten~          Contamination Elimination Diet);~        -  may depend upon time of exposure to GFD.~      Investigators studied two cohorts of celiac patients, both on GFD, for at least one year:~        -  cohort A: patients re-biopsied after three months on GCED;~        -  cohort B: patients re-biopsied after a minimum of further two years on standard GFD.~   "
65343|NCT02711683|"~     Alzheimer's disease (AD) is the commonest cause of dementia. There is no effective treatment~     to cure the disease. Cholinesterase inhibitors, such as donepezil, are widely recommended to~     patients with mild to moderate AD. But the cognitive function of most of the patients using~     donepezil gradually aggravate, with Mini-Mental State Examination(MMSE) score falling by 2~     points per year on average, and donepezil cannot effectively delay AD progress.~      DL-3-n-butylphthalide(NBP) is a synthetic chiral compound containing L- and D-isomers of~     butylphthalide. It is developed from L-3-n-butylphthalide, which was initially isolated as a~     pure component from seeds of Apium graveolens in 1978 by researchers of Institute of Medicine~     of Chinese Academy of Medical Sciences. Studies in the past several decades have demonstrated~     that NBP is effective in alleviating oxidative damage and mitochondria dysfunction, improving~     microcirculation. NBP was approved by the State Food and Drug Administration of China (SFDA)~     as a therapeutic drug for treatment of ischemic stroke in 2005 Not only for ischemic stroke,~     NBP has been reported to increase the expression of N-methyl-D-aspartate subtype glutamate~     receptor 2B(NR2B) and synaptophysin in hippocampus of aged rats after chronic cerebral~     hypoperfusion and increasing brain acetylcholine level, which are important processes~     involved in learning and memory. It could alleviate the learning and memory deficits induced~     by cerebral ischemia in rats. A multicentre, randomized, double-blind, placebo-controlled~     trial conducted by Professor Jia investigated that NBP was effective for improving cognitive~     and global functioning in patients with subcortical vascular cognitive impairment without~     dementia and exhibited good safety over the 6-month treatment period. The pathogenesis of AD~     involved mitochondria dysfunction and microcirculation dysfunction, which are the action~     targets of NBP. Investigators observed that MMSE score lowering slowly when using NBP~     treatment in patients with mild to moderate AD already receiving donepezil. But investigators~     lack of system evaluation and follow-up. Hence, investigators hypothesized that NBP may have~     therapeutic efficacy for patients with AD and designed the present study.~   "
65344|NCT02711670|"~     Thiazide diuretics will be more effective in lowering urine calcium excretion if taken at~     night as compared to the daytime. It will therefore be more effective in reducing kidney~     stone recurrence in nephrolithiasis patients with elevated urine calcium who are known to~     have increased risk of kidney stones at night time.~   "
65345|NCT02711657|"~     To study Fibrocytes in patients with Rheumatoid Arthritis, Interstitial lung disease and~     severe asthma and healthy controls.~   "
65346|NCT02711644|"~     Research has shown that a woman's lifestyle during pregnancy can predict the future health of~     a mother and her child. Improving the health of a mother during pregnancy can lead to the~     best health outcomes for mother and child in the short and long-term period. Currently there~     is a lack of understanding about how best to support women to achieve healthy weights during~     pregnancy. The aim of this study is to understand if additional lifestyle support, such as~     discussions about healthy eating and physical activity provided by a healthcare provider~     throughout pregnancy can help women achieve weights concordant with gestational~     recommendations.~      The healthcare providers in this study will be Registered Dietitians (RD). The intervention~     RD will be trained in Healthy Conversations, a supportive method of communication that~     utilizes open-ended questions to support patient-centered behaviour change. This allows women~     to explore health issues, identify barriers and discover solutions for improving their own~     health. This supportive prenatal counselling will occur with the intervention group~     concurrently while completing lifestyle questionnaires with the study RD. During these~     conversations, health goals will be made and will be followed up at future visits. The~     control group will complete the lifestyle questionnaires with the control RD; they will not~     receive additional lifestyle support at these visits. Women will be randomized into one of~     the two study groups and will be blinded to their study allocation. All participants will~     complete two in person visits and two follow-up telephone calls. Data will be collected on~     diet, physical activity, gestational weight gain, delivery, and infant outcomes.~      After this research is complete, the investigators hope to better understand the quantity and~     quality of additional support that may help women in Alberta achieve guideline concordant~     weight gain during pregnancy. If interventions can help women gain weight within the~     guidelines, pregnancy-related complications can be reduced. This information is also aimed at~     providing a better understanding of healthcare system requirements (i.e., type of providers~     and care model) in supporting women achieve healthy weights in pregnancy. The findings from~     this project have the potential to improve prenatal healthcare delivery across the province.~   "
65347|NCT02711631|"~     Regular exercise in patients who have heart disease is highly beneficial and improves quality~     of life and survival. Exercise training is considered a core component of cardiac~     rehabilitation (CR), which is a multicomponent program delivered to patients who have heart~     disease. However, it is severely underutilized because people simply don't have the time or~     the resources to travel to a CR centre to attend rehab appointments.~      The investigators have developed a novel virtual reality (VR) based CR exercise system~     (MedBike). This system consists of an exercise bike attached to a VR world; it makes exercise~     engaging and fun. Furthermore, patients can be monitored during exercise remotely over the~     internet. The investigators intend to perform a pilot randomized controlled trial in which 10~     patients are assigned to the MedBike system and 10 to standard CR. The investigators think~     that the MedBike system will increase exercise program compliance by providing an enjoyable~     and engaging exercise experience which can be performed in the comfort of one's own home. The~     investigators think that this will improve fitness (primary endpoint) in these patients. If~     the investigators demonstrate that home based exercise is feasible, the investigators plan a~     larger study to prove that it is something that should be broadly implemented in patients~     with heart disease.~   "
65350|NCT02711592|"~     The objective of this study is to see how pain management and its outcomes are effected when~     pharmacogenomic testing is used to determine patient specific pain medication and dosing. Our~     goal is to determine if through the use of analgesic genetic testing, TKA post-operative~     patients will see a decrease in narcotic consumption, postsurgical opioid- related adverse~     reactions, and length of stay, overall NRS pain scores and while maintaining or improving~     their satisfaction scores.~   "
65351|NCT02711579|"~     the purposes of this study are to evaluate the acute electrophysiological response in brain~     cortex to single oral dose of celecoxib (400mg once) in healthy volunteer and the~     electrophysiological alteration in brain cortex by long-term treatment of celecoxib (200mg~     twice-daily for 7 days) in healthy volunteer~   "
65352|NCT02711566|"~     Robot-assisted therapy has proven effective in the neuromotor rehabilitation of eg stroke~     survivors. Robots can be programmed to interact with patients by guiding their movements, by~     monitoring their performance and by quantifying the type and degree of their impairment.~      A distinctive element of multiple sclerosis is the involvement of a variety of functional~     systems, in a way that is highly subject-specific. This requires a personalization of~     treatment, and continuous adaptation to changes in condition. This points to a need for~     integrating patient assessment, definition of rehabilitation protocols, their administration~     and the assessment of their outcome.~      The goal of this study is to assess, in persons with MS, the efficacy of a type of~     robot-assisted training that was specifically designed to counteract incoordination and~     muscle weakness (typical of MS), tailored to individual type and degree of impairment, when~     compared to simple movement training.~   "
65353|NCT02711553|"~     The main purpose of this study is to evaluate the efficacy and safety of ramucirumab or~     merestinib or placebo plus cisplatin and gemcitabine in participants with advanced or~     metastatic biliary tract cancer.~   "
65354|NCT02711540|"~     Retrospective analysis of all patients receiving TAVI in the United Kingdom (UK). Stroke~     rates following TAVI are roughly 3%. There are several device and procedure related~     characteristics which may increase the risk of stroke. We will examine if there is a signal~     in the UK registry. This will be important is TAVI is to be extended down to lower risk~     patient cohorts.~   "
65355|NCT02711527|"~     This is a randomized, open-labelled study to study the effect of the different acupoints~     combination under TCM treatment principles by fNIRS.~      The investigator aim to recruited 36 depression subjects and go through 6 acupuncture~     treatment sessions in 3 weeks. They will be divided into 2 groups by randomization. (Group A~     n=18, Group B n=18) The participants will receive 2 acupuncture session per week for 3~     consecutively weeks. In each treatment session, all subjects in both groups will receive the~     same amount of needle insertion ( total 14 needles) , all needles will be retained for 30~     minutes. The whole treatment will last for around 45 minutes. No sedation will be conducted.~      Subjects in Group A will receive 14 needles based on the TCM theory Soothing liver-qi~     stagnation, all needles will be retained for 30 minutes. Acupoint combination: Taichong太衝~     (LR 3), Ligou蠡沟 (LR 5), Zhongdu 中都(LR6), Xiguan膝關 (LR 7), Ququan曲泉 (LR 8), Zhangmen章門(LR13),~     Qimen期門 (LR14).~      Subjects in Group B will receive 14 needles based on the TCM theory Soothing liver-qi~     stagnation and Tonifying the heart and the spleenand Invigorating the Yang Qi, all~     needles will be retained for 30 minutes. Acupoint combination: Taichong太衝 (LR 3), ,~     Sanyinjiao 三陰交 (SP 6), Xuanzhong懸鐘 (GB 39), Shenmen 神門 (HT 7), Zusanli 足三里(ST 36), Baihui~     百會(DU 20), Shenting神庭(DU24), Qihai 氣海(RN6), Guanyuan 關元(RN4). Teding Diancibo Pu~     (abbreviation: TDP) 特定電磁波譜 will be applied to Group B immediately after the needle~     insertion. This TDP device is a infra-red heat lamp which is commonly used by acupuncturists~     and Chinese Medicine Practitioner as a therapeutic substitute for moxibustion. The procedure~     will be lasted for 30 minutes in 30-40 cm above the specified acupoint Qihai 氣海(RN6) and~     Guanyuan 關元(RN4).~   "
65356|NCT02711514|"~     Comparison of Crossover rates of Radial Cardiac Catheterizations and/or PCIs into femoral vs~     published literature~   "
65357|NCT02711501|"~     The aim of this study was to investigate if using lasers instead of scalpel for flap~     advancement in bone augmentation procedures would reduce post-operative swelling and pain.~   "
65358|NCT02711488|"~     The objective of the project is to develop, implement and evaluate a prevention program for~     obesity among adolescents in Brazil combining the primary care health system implemented in~     the country in recent decades with primary prevention at schools.~   "
65359|NCT02711475|"~     Diminutive polyps, measuring between 1 and 5 mm, represent the vast majority of colorectal~     polyps encountered during colonoscopy. Since the chance of harboring advanced adenoma or~     carcinoma in this kind of polyps is very low, a remove and discard technique has been~     proposed.~      The differentiation between adenoma/non adenoma polyps is based on the use of endoscopes~     equipped with high definition, magnification and optical filters.~   "
65360|NCT02711462|"~     This Phase 1 study will be a double blind, third party open (ie, subject blind, investigator~     blind and Sponsor open), randomized, placebo controlled, single and multiple dose escalation~     study in healthy subjects, females of non childbearing potential and males between the ages~     of 18 and 55 years, inclusive. There may be up to 11 Cohorts in the study. Approximately 7~     cohorts are anticipated in the Single Dose (SD) portion of the study and up to 4 cohorts are~     anticipated in the Multiple Dose (MD) portion of the study.~      Following the last subject Day 28 visit from the first two single dose cohorts (Cohorts 1 and~     2), all available data inclusive of Day 28 will be evaluated for PK, immunogenicity, safety~     and tolerability. FDA review and agreement to move forward will take place before the~     remaining single dose cohorts and the multiple dose phase (Cohorts 3 to 11) can be initiated.~      A total of up to approximately 82 subjects are anticipated to be enrolled in the study. The~     duration of dosing in the multiple dose cohorts would be 4 weeks and the regimen may include~     weekly (total of 5 doses), every 2 weeks (total of 3 doses) or monthly dosing (total of two~     doses).~   "
65361|NCT02711449|"~     To test whether 125 mg preoperative methylprednisolone intravenously can reduce postoperative~     pain after laparoscopy for suspected appendicitis and to test whether preoperative~     methylprednisolone can reduce postoperative fatigue, increase quality of sleep, reduce nausea~     or vomiting, reduce duration of convalescence and increase overall quality of recovery after~     laparoscopy for suspected appendicitis.~   "
65362|NCT02711436|"~     The aim of the study is to compare orbital and central nervous system (CNS) imaging with~     Computed Tomography (CT) scan to that of Fast Magnetic Resonance Imaging (Fast MRI) in~     children with mild, moderate or severe orbital cellulitis with medical indications for~     imaging.~   "
65363|NCT02711423|"~     This two-part study is designed to assess the safety, tolerability, and PK of gantenerumab in~     healthy volunteers. Part I (dose escalation) will randomly assign participants to receive a~     single blinded SC dose of gantenerumab or placebo. Part II (PK extension) will randomly~     assign participants to receive a single open-label SC dose of ganenerumab at different dose~     levels according to safety assessments from Part I.~   "
65364|NCT02711410|"~     Background:~      Clopidogrel, an antiplatelet prodrug, is widely used for prevention of the recurrent~     cardiovascular events. CYP2C19 is one of the crucial enzymes for the activation of~     clopidogrel. Recent studies, mostly done in cardiovascular patients, showed association of~     the CYP2C19 genotypes with recurrent cardiovascular events. However, prospective data on the~     impact of the genetic variants in stroke patients are limited.~      Methods:~      Five hundred and eighteen Japanese non-acute stroke patients treated with clopidogrel were~     registered at 14 institutions. Three CYP2C19 variants (CYP2C19*2, *3, *17) were genotyped and~     the patients were classified into three clopidogrel metabolizer groups inferred from the~     CYP2C19 genotypes: extensive (EM: *1/*1), intermediate (IM: *1/*2 or *1/*3), and poor (PM:~     *2/*2, *2/*3, or *3/*3). The CYP2C19*17 carriers were excluded from the analysis. The~     antiplatelet effects of clopidogrel were assessed by Adenosine diphosphate (ADP) -induced~     platelet aggregation and vasodilator-stimulated phosphoprotein (VASP) phosphorylation,~     expressed as VASP index. The endpoint was the composite incidence of stroke, transient~     ischemic attack, myocardial infarction, revascularization, other thromboembolic disease, or~     cardiovascular death during 2 years of follow-up.~   "
65365|NCT02711397|"~     Treatment for celiac disease (CD) is a lifelong strict gluten-free diet (GFD). Patients~     should be followed-up with dietary interviews and serologic tests for CD markers to ensure~     adherence to the diet. However, none of these methods offer an accurate measure of dietary~     compliance. Our aim was to evaluate the measurement of gluten immunogenic peptides (GIP) in~     stools as a marker of GFD adherence in CD patients and compare it with traditional methods of~     GFD monitoring.~      We performed a prospective, non-randomized, multicentre study including 188 CD patients on a~     GFD and 73 healthy controls on a gluten-containing diet. Subjects were given a dietary~     questionnaire and fecal GIP quantified by ELISA (iVYLISA GIP-S kit). Serological anti-tissue~     transglutaminase (anti-tTG) IgA and anti-deamidated gliadin peptide (anti-DGP) IgA antibodies~     were measured simultaneously.~   "
65366|NCT02711384|"~     Introduction: Sevoflurane is the most volatile anesthetic used during CPB. In addition to the~     cardioprotective effect, Sevoflurane also promotes reduction in systemic vascular resistance~     and also an important role in anesthesia maintenance during surgery, preventing patients~     awaken in the intraoperative. To avoid the awakening during surgery, assessment of the level~     of consciousness through the bispectral index (BIS) has been the most common method used by~     anesthesiologists. During cardiac surgery the most critical moment may be the patient is~     awaken during the warm up phase of CPB. The monitoring of this phase with the BIS has become~     efficient as to alert the anesthetist that the patient may be waking up.~      Aims: The primary endpoint of this study is to determine the ideal minimum dose of~     sevoflurane (ED 95) that 95% of patients undergoing anesthesia during CPB in cardiac surgery~     have no intraoperative awareness.~      Methodology: Dixon's up-and-down technique is a commonly used method to define MAC (27-30).~     The anesthetic concentration applied to the first patient is estimated by clinical~     experience. If there BIS values below 50, the concentration of inhalational anesthetic in~     subsequent patient is decreased by 20%. If the BIS show values greater than or equal to 50~     for a period ≥ 1 minute steadily, the concentration is increased by 20% in the next patient.~     In each series of patients, the pairs of independent cross in order measurements are~     identified. Logistic regression is used to determine the ideal minimum dose of sevoflurane~     (ED 95) that 95% of patients undergoing anesthesia during CPB in cardiac surgery have no~     intraoperative awareness.~   "
65367|NCT02711371|"~     The aim of this functional magnetic resonance imaging (fMRI) study is to find out whether and~     how social and emotional brain function are altered in dependent cannabis users relative to~     healthy non-using control subjects after a 28 supervised abstinence period. Previous research~     in cannabis users has predominantly focused on cognitive functions. Moreover, studies have~     implicated that observed deficits in cannabis users may regenerate after a prolonged~     abstinence period. Findings might provide important information with respect to relapse~     vulnerability.~   "
65368|NCT02711358|"~     The aim of the investigators study is to test the analgesic effect of rectal indomethacin~     during Intrauterine device insertion.~   "
65369|NCT02711345|"~     A phase I study of LTT462 in patients with advanced solid tumors that harbor MAPK pathway~     alterations.~   "
65370|NCT02711332|"~     This is an open, single-centre trial investigating the impact of haemolysis after capillary~     blood collection to the measured potassium concentration in Plasma healthy subjects. Each~     subject will have four capillary blood collections on different fingers. Two on the right and~     two on the left hand. Additionally as a reference a venous blood collection will be~     conducted.~   "
65371|NCT02711319|"~     to optimize the functional outcome in early phase of gait rehabilitation in subacute~     incomplete SCI patients using rTMS as an additional treatment to physical therapy (e.g. to~     gait training in Lokomat®). Using this add-on therapeutic strategy, we expected larger~     improvement of gait function than with physical therapy alone.~   "
65372|NCT02711306|"~     Metabolic syndrome (MS) is a complex disease with a cluster of risk factors and clinical~     features, which includes central or abdominal obesity, atherogenic dyslipidemia, impaired~     glucose regulation, hyperinsulinemia, high blood pressure, and concomitance of~     pro-inflammatory cytokine and insulin resistance. Glucomannan (GM) is a water-soluble dietary~     fiber derived from the root of Amorphophallus konjac that can improve blood sugar, blood fat~     concentration, and weight management, and has other health benefits.The purposes of this~     study are going to investigate the effects of KGM noodle (KGN) as stable food to MS and~     diabetic patients.~   "
65392|NCT02711046|"~     Long standing oral submucous fibrosis(OSMF) is associated with involvement~      of the oral submucosa and the muscles of mastication leading to difficulty in mouth~      opening. Various surgical modalities are mentioned for release but each has its own~     limitations.The aim of the study was to evaluate the change in mouth opening in patients of~     OSMF after excision of fibrous bands followed by coronoidotomy and surgical defect coverage~     by single stage nasolabial flap.~   "
65393|NCT02711033|"~     This study investigates the safety and feasibility of laparoscopic-assisted total gastrectomy~     with spleen-preserving splenic hilum lymph node dissection for proximal advanced gastric~     cancer and compares the early results of this procedure with open total gastrectomy.~   "
70996|NCT02637687|"~     This is a multicenter, open label, Phase 1/2 study in pediatric patients with advanced solid~     or primary CNS tumors. LOXO‑101 (larotrectinib) will be administered orally (PO) twice daily~     (BID), with the dose adjusted by body surface area (BSA).~   "
65373|NCT02711293|"~     Home delivery of antiretroviral therapy (ART) by community health workers (CHWs) has the~     potential to reduce key barriers to ART care retention. The aim of this study is to determine~     whether CHW-led home delivery of ART for patients who are stable on ART combined with~     facility-based care for those not stable on ART is non-inferior to the standard of care~     (facility-based care for all ART patients) in achieving and maintaining virological~     suppression. The primary endpoint of this trial is the proportion of ART patients (regardless~     of whether they were clinically stable on ART at enrollment) who are in viral failure at the~     end of the study period. The non-inferiority design applies only to this primary endpoint.~     The margin of non-inferiority was set at a Risk Ratio (comparing intervention to control) of~     1.45. This is a cluster-randomized controlled trial set in Dar es Salaam. The unit of~     randomization is a healthcare facility with its surrounding neighborhoods (the 'catchment~     area'). We matched all 48 healthcare facilities offering ART services and having affiliated~     public-sector CHWs in Dar es Salaam into pairs (stratified by district) based on having a~     similar number of patients currently on ART. In each pair, one cluster was randomized to the~     intervention and one to the control arm. The intervention consists of home visits by CHWs to~     provide counseling and deliver ART to patients who are stable on ART, while the control is~     the standard of care (facility-based ART care and CHW home visits at least every three months~     without ART home delivery). In addition, within each study arm, half of the healthcare~     facilities were randomized to enhanced CHW-led nutrition counseling and half to standard~     counseling.~   "
65374|NCT02711280|"~     The purpose of this study is to determine whether Propofol and Sevoflurane affect the~     oxidative stress and apoptosis status in children undergoing hypospadias repair surgery.~   "
65375|NCT02711267|"~     The overall aim of this clinical study is to investigate the ability of dermal open flow~     microperfusion to assess bioequivalence and non-bioequivalence of acyclovir formulations in~     the skin of healthy volunteers.~   "
65376|NCT02711254|"~     The purpose of this study is to evaluate improvement in pain and function following~     implantation of a new device, called the Phantom Knee System, in patients needing unloading~     of the medial compartment of the knee~   "
65377|NCT02711241|"~     The purpose of this study is to find out an optimal way of analgesia in case of acute~     infectious gastroenteritis the investigators are going to compare two medicines that are used~     on everyday basis (without being ever before subject to scientifical study): Dipyrone and~     papaverine The study is done in the Emergency Department setting. Thus, only first 6 hours of~     treatment is included in study~   "
65378|NCT02711228|"~     The purpose of the study is to assess the impact of immunoglobulin treatment by subcutaneous~     injections every 2 weeks (biweekly) on a cohort of patients with primary and secondary immune~     deficiencies. The full study will consist of safety, efficacy and Quality of Life (QoL)~     evaluations and a pharmacokinetic (PK) sub-study. The primary objectives of the study are to~     determine tolerability and safety of biweekly IgPro20 injection regimen and to compare PK~     outcomes on weekly and biweekly IgPro20 therapy.~      Patients who have received and/or are currently receiving immunoglobulin G (IgG) in~     intravenous (IVIg), or subcutaneous (SCIg) infusions are eligible for inclusion if they meet~     inclusion/exclusion criteria.~      The study consists of two parts. In Part 1 of the study enrolled subjects will receive~     IgPro20 weekly for either 12 weeks (for patients on SCIg infusion prior to the study) or 24~     weeks (for patients on IVIg infusion prior to the study). Part 2 will consist of a biweekly~     treatment with IgPro20 for 52 weeks, for both groups.~      Additionally, study subjects meeting inclusion criteria for the PK sub-study will undergo a~     PK sample collection for 1 week and 2 weeks in study Parts 1 and 2, respectively.~   "
65379|NCT02711215|"~     Selective serotonin reuptake inhibitors (SSRIs) raise serotonin (5-HT) in the synaptic cleft~     and are the current first line of pharmacological antidepressive treatment. Yet, there is a~     missing link between this first molecular step in their mechanism of action and observed~     clinical improvement. We have determined to establish a framework combining genuine molecular~     and functional imaging, i.e. hybrid pharmaco-PET/MR imaging, of the human serotonergic system~     in order to predict antidepressant treatment response.~      Objectives:~        1. To predict antidepressant treatment response from data obtained using hybrid PET/MR with~          acute pharmacological challenge.~        2. To discriminate healthy from depressed subjects using this paradigm.~        3. To establish models connecting regional changes in occupancy of serotonin transporters~          (5-HTT) following citalopram infusion, with changes in brain activation and connectivity~          of major resting-state hub networks.~      Design: Randomized, double-blind, placebo-controlled, cross-over mono-center study.~      Materials and methods:~      40 major depressed (MDD) and 40 healthy subjects will undergo 2 PET/MR scans on a 3T SIEMENS~     mMR Biograph scanner: 1. challenge with citalopram 8mg 2. placebo (saline). After structural~     imaging, functional MRI will be continuously acquired. [11C]DASB will be applied using a~     bolus + constant infusion paradigm to probe 5-HTT binding potentials and monitor 5-HTT~     occupancy with drug challenge, applied after 70min, in a single session. Scanning will be~     terminated 80min after challenge. MDD patients will receive subsequent escitalopram treatment~     with repeated evaluation of response for 3 months.~   "
65380|NCT02711202|"~     The aim of the study is to evaluate the efficacy of new immunosuppressive protocol based on~     two applications of anti-CD52 MabCampath (Alemtuzumab) a single dose of anti-TNF-α Remicade~     (infliximab) monoclonal antibodies in the early posttransplant period followed by either~     monotherapy based on tacrolimus or sirolimus.~   "
65394|NCT02711020|"~     The purpose of this study is to perform an efficacy study of Personal Construct Therapy,~     which focuses on the construction of self and others, for women diagnosed with fibromyalgia~     who have also comorbid depressive symptoms. To that aim, it will be compared with Cognitive~     Behavioral Therapy, which is an already well-established treatment in this area.~   "
65395|NCT02711007|"~     After standard multimodal therapy, the prognosis of relapsed and unresectable high-grade~     osteosarcoma is dismal and unchanged over the last decades.Thus, the investigators explored~     apatinib activity in patients with relapsed and unresectable osteosarcoma after the failure~     of first-line or second-line chemotherapy. Patients >16 years, progressing after standard~     treatment, were eligible to receive 500 mg or 750 mg of apatinib once daily until progression~     or unacceptable toxicity. The primary end point was progression-free survival (PFS) at 4~     months and objective response rate (ORR). Secondary objectives were PFS, overall survival~     (OS), clinical benefit rate (CBR), defined as no progression at 6 months and safety.~   "
65381|NCT02711189|"~     Background:~      Oxytocin is a naturally occurring substance in the body. Studies show that oxytocin may~     affect how the body responds to alcohol. Researchers believe oxytocin may be a possible~     treatment for alcoholism.~      Objective:~      To test whether the hormone oxytocin affects the brain reward system. To see if it affects~     how people respond to alcohol and other rewarding things in life like food and seeing loved~     ones.~      Eligibility:~      Men ages 21-55 who have an alcohol use disorder.~      Design:~      Participants will have two 6-day inpatient study visits. They will have:~        -  Study medication or placebo given twice daily as a nasal spray.~        -  Height and weight measured.~        -  Medical history.~        -  Blood and urine tests.~        -  Breath tested for alcohol.~        -  Electrocardiogram.~        -  An alcohol administration session. In a bar-like room, where participants will consume~          four alcoholic drinks.~        -  Magnetic resonance imaging (MRI). The MRI scanner is a metal cylinder in a strong~          magnetic field. Participants will lie on a table that slides in and out of the cylinder.~          A device called a coil will be placed over their head. Participants will complete tasks~          on a computer screen.~        -  In another alcohol session. they will drink an alcoholic beverage then answer questions.~          Participants will get a tab for eight more drinks ($3.00 per drink). They may drink any~          of the drinks or take the money. Participants will hold and smell a glass of water and~          their favorite alcoholic drink.~        -  Heart rate and blood pressure will be monitored.~        -  Saliva samples will be collected~        -  Computer tasks and questionnaires.~      About one week after the end of visit 2, participants will return to clinic for a follow-up~     visit. Symptoms and side effects will be evaluated.~   "
65382|NCT02711176|"~     This study is conducted to investigate whether the efficacy of single-dose triple therapy~     (Esomeprazole 40 mg, Tinidazole 1 g, and Levofluxacine 500 mg) for 14 days is superior to~     double-dose lansoprazole 30 mg, amoxicillin 1 g and clarithromycin 500 mg for 14 days in the~     treatment of H pylori infection.~   "
65383|NCT02711163|"~     The aim of this study is to assess the hypoallergenicity of a new thickened extensively~     hydrolyzed formula, in infants with confirmed cow's milk protein allergy assessed through a~     double blind placebo controlled food challenge, followed by a 3-month open feeding period.~   "
65384|NCT02711150|"~     The purpose of this study is to assess whether application of an epidural positioning device~     to a parturient seated for neuraxial anaesthesia increase the size of the paramedian target~     area for neuraxial needle insertion. Lumbar ultrasonography will be performed in 30 pregnant~     women in two seated positions: (P1), lumbar flexion; and (P2), as in P1 with the epidural~     positioning device applied. For each position, the size of the 'target area', defined as the~     visible length of the posterior longitudinal ligament will be measured at the L3-L4~     interspace.~   "
65385|NCT02711137|"~     The purpose of the Study is to select a dose and assess the safety and tolerability of~     INCB057643 as a monotherapy (Part 1 and Part 2) and in combination with standard-of-care~     (SOC) agents (Part 3 and Part 4) for subjects with advanced malignancies.~      Part 1 will determine the maximum tolerated dose of INCB057643 and/or a tolerated dose that~     demonstrates sufficient pharmacologic activity. Part 2 will further evaluate the safety,~     preliminary efficacy, PK, and PD of the dose(s) selected in Part 1 in select tumor types~     including solid tumors, lymphomas and other hematologic malignancies. Part 3 will determine~     the tolerated dose of INCB057643 in combination with select SOC agents; and assess the safety~     and tolerability of the combination therapy in select advanced solid tumors and hematologic~     malignancies. Part 4 will further evaluate the safety, preliminary efficacy, PK, and PD of~     the selected dose combination from Part 3 in 4 specific advanced solid tumor and hematologic~     malignancies.~   "
65386|NCT02711124|"~     The aim of this study is to evaluate whether increased level of hemoglobin A1c (HbA1c)~     correlates to higher level of platelet reactivity assessed by impedance aggregometry in~     patients with diabetes mellitus undergoing elective coronary artery bypass grafting (CABG).~   "
65387|NCT02711111|"~     Class III malocclusions may originate in a retrognathic maxilla, a prognathic mandible or~     both. Young patients with class III malocclusion and maxillary hypoplasia are conventionally~     treated with a protraction facemask in order to stimulate forward growth of the upper jaw.~     This treatment option is often inducing unwanted side effects including mesial migration of~     the teeth in the upper jaw and clockwise rotation of the mandible. Because skeletal effects~     are often difficult to achieve with this approach, more pronounced class III malocclusions~     cannot be addressed by face mask therapy. These children cannot be treated during childhood~     and end up in major orthognathic surgery at full-grown age. To be able to treat also the more~     pronounced class III malocclusion and to minimize dentoalveolar compensations new treatment~     methods were developed which uses skeletal anchorage.~   "
65388|NCT02711098|"~     Cardiac arrest is at present a major cause of mortality as well as a cause of disability for~     the surviving victims.In Europe, every year counts as 300,000 cardiac arrests responsible for~     250,000 deaths. Thus, less than 20 % of patients discharged home with impaired quality of~     life associated with symptoms of tiredness, stress, anxiety. The prognosis is related to the~     initial cardiac rhythm present during the initiation of resuscitation. Recent progress in the~     improvement of mortality and neurological outcome has been achieved over the last decade~     thanks to the systematic implementation of a period of targeted temperature control between~     32 and 34 ° C in patients who benefited from the realization of at least one electrical~     external shock.~      There are theoretical and clinical arguments to think that achieving the same way a period of~     targeted temperature control between 32 and 34 ° C in patients treated for cardiac arrest~     with a non- shockable rhythm on arrival can also benefit from this procedure. However other~     arguments are against this hypothesis including an increase in the risk of infection ,~     worsening of the patient's hemodynamic status with no benefit to him. To answer this~     question, we conduce a randomized multicenter study testing the potential improvement of~     neurological outcome through this procedure targeted temperature control between 32.5 and~     33.5 ° C in these patients.~      IL Ancillary Study of HYPERION Trial will determine impact on inflammatory biomarkers of two~     temperature target for targeted temperature management (33°C or 37°C) after cardiac arrest in~     non-shockable rhythm.~   "
65389|NCT02711085|"~     This study will explore the contribution of stress-system activity to pain and functional~     disability in the acute stage of traumatic musculoskeletal injury, and to the maintenance of~     symptoms after 3, 6 and 12 months post-injury.~   "
65390|NCT02711072|"~     SPINAL anesthesia is commonly used for cesarean section, and it has become a popular practice~     to add opioids to spinal solutions to enhance and prolong intraoperative and postoperative~     analgesia. high incidence of side effects was noted. is there any alternative?~   "
65391|NCT02711059|"~     The aims of this study is to analyse if insulin resistance in primary hyperparathyroidism~     (pHPT) is normalised after parathyroid adenomectomy and if glucose tolerance test may be~     useful as a diagnostic tool by predicting potential improvement of insulin sensitivity after~     biochemical cure of pHPT.~   "
65397|NCT02710981|"~     This is a prospective self controlled clinical trial. Women with clomiphene Citrate failure,~     and thin endometrium were recruited (N = 42). In their 6th (Clomiphene citrate only) cycle,~     women continued on Clomiphene citrate 100 mg/ day for 5 days, and had sonographic measurement~     of their endometrial thickness , and Doppler evaluation of their uterine arteries on the day~     of HCG administration. In 7th cycle, women (N = 36) were given usual dose of Clomiphene~     citrate supplemented with sildenafil vagina gel (5 gm, containing 50 mg sildenafil) twice~     daily from cycle day 8 till the day of HCG injection. Endometrial thickness and uterine~     artery Doppler were measured on the day of HCG administration.~   "
65398|NCT02710968|"~     Despite advances in prenatal diagnosis and postnatal therapies, including extracorporeal~     membrane oxygenation (ECMO), inhaled nitric oxide therapy, and ventilator strategies that~     minimize ventilator-induced lung injury, morbidity and mortality rates for babies with~     congenital diaphragmatic hernia (CDH) remain high. The survival relates to the degree of~     prenatal lung compression and the subsequent impairment of pulmonary function following~     delivery. Prenatal assessment by ultrasound or magnetic resonance imaging allows to estimate~     the severity by relating the circumference of the lung contralateral to the hernia to the~     fetal head circumference lung to head ratio (LHR) and by noting the degree of upward~     herniation of the liver. Based on the observed to expected lung to head ratio (O/E LHR),~     prenatally diagnosed congenital diaphragmatic hernia can be prognostically assessed. While~     overall survival of congenital diaphragmatic hernia is approximately 60%, an O/E LHR <25% is~     associated with survival between 11-24%.~      The rationale for fetal therapy in severe congenital diaphragmatic hernia is to restore~     adequate lung growth for neonatal survival. Prenatal tracheal occlusion obstructs the normal~     egress of lung fluid during pulmonary development leading to increased lung tissue stretch,~     increased cell proliferation, and accelerated lung growth. European colleagues have developed~     intrauterine endoscopic techniques (fetoscopy) to position and remove endoluminal tracheal~     balloons in utero (fetoscopic endotracheal occlusion = FETO). Recently, the Belgium group~     published summary results of FETO showing an improved survival in 175 patients with isolated~     left CDH from 24% to 49%. Our goal with this pilot study is to study the feasibility of~     implementing FETO therapy in the most severe group of fetuses with left CDH (O/E LHR < 30%).~     which will be considered in two subgroups. Those with and O/E LHR <25% (severe group) and~     those with an O/E between 25 to <30% (less severe group).~   "
65399|NCT02710955|"~     The aim of this study is to evaluate the efficacy of a new thickened formula on regurgitation~   "
65400|NCT02710942|"~     The goal for this pilot study is to assess the acceptability of two online self-guided~     programs for migraines. The programs are part of the investigators' collection of my~     Wireless Headache Interventions (myWHI). The Specialized Program for Headache Reduction~     (SPHERE) is a program that teaches cognitive and behavioural skills/techniques to help manage~     headaches. The PeRsonalized Intervention for Self-Management of Migraine (PRISM) helps users~     to discover their headache triggers and provides recommendations for managing them. This~     pilot will also assess the feasibility of the study protocol to inform a full scale~     randomized controlled trial (RCT).~   "
65401|NCT02710929|"~     Specific Aims:~        1. To find the genetic variations associated with spatial working memory performance in~          patients with ADHD by using genome-wide association studies (GWAS);~        2. To find the genetic variations associated with spatial working memory performance in~          healthy subjects by using GWAS;~        3. To recruit a validation sample and to replicate the findings from the initial GWAS;~        4. To test whether genetic variations significantly associated with spatial working memory~          are also associated with ADHD.~   "
65402|NCT02710916|"~     Glaucoma is the first cause of irreversible blindness worldwide with more than 60 millions~     people affected in 2010. It is defined as a neurodegenerative disease characterized by a~     progressive loss of retinal ganglion cells (RGC), visual field deterioration and optic nerve~     excavation. Intraocular pressure (IOP) is the most common risk factor. Despite its severity,~     its impact on quality of life and an existing treatment that can delay visual field damages,~     there is no recommended strategy to screen the disease. Clinical evaluation of optic nerve~     head excavation performed either by ophthalmologists or glaucoma specialists is highly~     inter-observer dependent and limits its accuracy to diagnose glaucoma. Additionally, up to 30~     to 40% of nerve fiber layer may be lost before detecting first visual field defects, thus~     making this tool not accurate enough for screening purposes.~      Spectral-Domain Optical coherence tomography (SD-OCT) imaging technology allows precise and~     reproducible measurements of optic nerve head structures and retinal layers mainly related to~     the speed of acquisition and an axial resolution of 5 microns. New SD-OCT parameters have~     been developed to improve its diagnostic accuracy for glaucoma disease. The investigators~     therefore investigate performances of SD-OCT to discriminate glaucoma patients and controls.~     All subjects will undergo SD-OCT imaging (Spectralis™ OCT, Version 6.3, Heidelberg~     Engineering, Germany) and other study procedures in one single visit. All examinations~     performed on the subjects are non-significant risk.~   "
65403|NCT02710903|"~     A maximum of 220 subjects with a minimum of 25 years will be recruited and examined for this~     1-7 visit, up to 35 days research study: Subjects will be genotyped to identify variants of~     the interleukin-29 (IL29) and interleukin-28B (IL28B) genes and placed in one of the 4~     groups: 50 subjects with dominant allelic variants with healthy periodontium, 50 subjects~     with dominant allelic variants with periodontitis, 50 subjects with IL29 (rs30461) or any of~     IL28B (rs11083519; rs8105790; rs8099917) single nucleotide polymorphism's (SNP) variants and~     healthy periodontium, and 50 subjects with IL29 (rs30461) or any of IL28B (rs11083519;~     rs8105790; rs8099917) SNP variants and periodontitis. Visits will consist of outpatient~     procedures including oral examinations, oral prophylaxis or periodontal scaling and root~     planing, collection of gingival crevicular fluid, dental plaque, saliva, and blood samples.~     Analysis will include salivary DNA isolation and pyrosequencing to determine IL29 and IL28B~     genotype, mediator analysis of gingival crevicular fluid, dendritic cell differentiation and~     inflammatory mediator analysis, and whole-genome shotgun sequencing plaque analysis. Clinical~     outcomes will include measurements of periodontal disease progression and inflammation, such~     as clinical attachment level (CAL), pocket depth (PD), bleeding on probing (BOP), gingival~     index (GI), and plaque index (PI).~      Primary Objective: To determine the impact of IL29 and IL28B SNP variants on periodontal~     disease expression and local inflammatory response during stent-induced biofilm overgrowth.~      Secondary Objective: To evaluate in vitro the impact of IL29 and IL28B SNP variants on~     cell-mediated, innate inflammatory response.~   "
65404|NCT02710890|"~     EP0060 is a multicenter, open-label study to evaluate the safety and tolerability of~     intravenous (iv) Lacosamide (LCM) in pediatric subjects >= 4 to < 17 years of age with~     epilepsy.~   "
65405|NCT02710877|"~     The study aims to determine whether the use of automated intermittent devices for labor~     analgesia could prevent the increase of instrumental deliveries, with same analgesia.~      Moreover it will evaluate if automated devices can allow a reduction of health-care burden.~   "
65407|NCT02710851|"~     This phase Ⅱ clinical study was designed to evaluate the immunogenicity and safety of the~     novel recombinant HPV type 6/11 bivalent vaccine, manufactured by Xiamen Innovax Biotech CO.,~     LTD., in healthy volunteers aged 18-55 years of age at enrollment. The study volunteers would~     be randomized to receive the 3 different formulations of the novel HPV vaccine or placebo~     vaccine (recombinant hepatitis E vaccine) administered intramuscularly according to a 0-1-6~     month schedule. This is a double-blind study.~   "
65408|NCT02710838|"~     The gastric cancer is the second most frequently diagnosed cancer and the third leading cause~     of cancer death in China.80%-90% patients were detected at middle and later stage.The~     five-year survival rate for advanced gastric cancer patients is less than 10% due to the~     shortage of effective treatment method.The five-year survival rate for early gastric cancer~     patients is beyond 90%.The reason for poor diagnosis and treatment is that current methods do~     not achieve the diagnosis of early gastric cancer.Endoscopy with biopsy is still the main~     method for confirming gastric cancer.But it is limited to identify early gastric cancer and~     it leads to the low diagnostic rate of early gastric cancer.~      Infrared endoscopic imaging is a new great potential method of diagnosis of early gastric~     cancer, since the first report in the 1990s, people have been exploring in this field.~     Through intravenous injection of exogenous contrast medium, such as the indocyanine green, it~     makes mucosal lesions highlight,and avoids the interference of background light.If specific~     target molecular is linked to the contrast medium,the specific imaging of the lesion can be~     presented. What is more,due to the strong penetration power of infrared light,its imaging~     depth also increases significantly.Indocyanine green had also been demonstrated safe in~     clinical studies and widely used. On this basis,we apply for the research about near-infrared~     endoscopy to diagnose early gastric cancer,and discuss its feasibility of the infrared~     endoscopy to diagnose early gastric cancer and clinical value.~   "
65409|NCT02710825|"~     Osteopathic care impact on postoperative pain assessed by osteopathic session, evaluated by~     EVENDOL scale surgery on children with congenital heart disease~   "
65410|NCT02710812|"~     The proposed study is an observational, prospective, multicenter study of patients undergoing~     neoadjuvant therapy for medium-low rectal cancer.~      Recently the investigators have published the findings of a multicenter Italian phase II~     study showing that the rate of local recurrence, with a 3 year follow-up, is less than 5% in~     patients with baseline T2-3 mid-low rectal cancer who, after preoperative chemoradiotherapy~     (pCRT), showed a major clinical response and underwent a transanal local excision. Based on~     these results, an organ-sparing approach for patients showing a major clinical response is~     feasible without reducing the good results obtained with the standard treatment. While a~     phase III trial is the best way to compare the standard treatment with the organ-sparing~     approach (local excision or wait-and-see) it is impracticable and likely unethical. An~     observational study is therefore one of the best way to evaluate the impact that an~     organ-sparing approach may have on oncological outcomes, quality of life, and bowel function~     for patients with rectal cancer who, after a pCRT, show a clinical major/complete response.~      This phase II trial is designed to test the hypothesis that conservative treatments, in~     patients with low-mid rectal cancer who undergo a major or complete clinical response after~     neoadjuvant treatment, will be safe and effective compared to standard surgery.~      The investigators will compare rectum-sparing approaches to standard surgery, firstly in~     terms of rate of organ preservation at 2 years. Additionally they will compare survival~     outcomes (DFS, OS), stoma rates, clinical and tumor factors related to pathological complete~     response, correlation between major and complete clinical response.~      To add value, the investigators will measure QoL in patients treated with rectum-sparing~     approaches in comparison to patients treated with standard surgery (TME or abdomino-perineal~     amputation).~      Rectum-sparing approach can be considered clinically acceptable if percentage of conservation~     of the rectum at two years is not less than 50%.~      The collected data on 164 patients who underwent rectum-sparing allow to test the~     hypothesis that the rectum is preserved in 60% of patients with 80% power (exact binomial~     test for proportions, alpha = 5 %, 1 tail) and the study will be considered positive if it~     obtains a frequency of conservation of the rectum of not less than 87 cases.~      The analysis results will be reported in accordance with STROBE guidelines (von Elm et al.,~     2008). For all analyzes, continuous variables are described using the mean and standard~     deviation of position and appropriate measures when appropriate. Categorical variables will~     be described using the contingency tables.~   "
65411|NCT02710799|"~     The aim of this study is evaluate the effects of telephone teleconsultations to primary care~     physicians (compared to the state's referral protocol) in the referrals waiting list for~     endocrinological appointments.~   "
65412|NCT02710786|"~     To evaluate effect on comorbid disease and weight loss five years after Roux-en-Y gastric~     bypass (RYGB) surgery for morbid obesity.~   "
65413|NCT02710773|"~     Gait impairment is a common cause of disability in patients who have experienced a stroke and~     recovery of walking is a priority goal. Gait outcome is a significant factor that influences~     a patient's chance of returning to the social life activity and rehabilitation is an~     effective treatment for restoring gait in these patients. Learning to walk backwards~     correctly has been recommended to improve the movement components required for walking~     forwards. Several studies demonstrated that during backward walking the muscle activity is~     higher, more oxygen consumption, metabolic and cardiorespiratory activity are required and~     the same motor program is used comparing to during the forward walking. It has been suggested~     that backward walking therapy may be promoted as a treatment strategy to improve gait in~     stroke patients.~      The main goal of this project is to investigate the effectiveness of the backward walking~     therapy on gait improvement and spasticity in post stroke patients.~   "
65414|NCT02710760|"~     The purposes of this study are (1) to determine whether child nutrition-focused adoption~     encouragement messages focused on Quality Protein Maize (QPM) and the availability of small~     quantities of QPM seed can be effective at increasing QPM adoption and health outcomes for~     young children, and (2) to determine whether consumption encouragement messages and~     techniques (e.g., containers for earmarking) can be effective at increasing QPM targeting to~     and health outcomes for young children.~   "
65415|NCT02710747|"~     To value the accuracy of the dosing algorithm published by the International Warfarin~     Pharmacogenetics Consortium in Chinese patients after heart valve replacement.~      To value the accuracy of warfarin pharmacogenomics algorithm by the algorithm calculated dose~     and actual dose in the Chinese patients.~   "
65416|NCT02710734|"~     The aim of this study is to evaluate a risk-adapted approach to the treatment of muscle~     invasive bladder cancer. Each baseline transuretheral resection of bladder tumor (TURBT)~     sample will be sequenced while proceeding with neoadjuvant accelerated methotrexate,~     vinblastine, doxorubicin, and cisplatin (AMVAC) chemotherapy. Based on the mutational profile~     and the post AMVAC TURBT findings, patients will be treated with active surveillance~     (experimental arm), or standard of care intravesicle therapy, chemoradiation or surgery. We~     hypothesize that this approach will lead to non-inferior metastasis-free survival at 2 years,~     while preserving the bladder and thus quality-of-life for a proportion of patients.~   "
65417|NCT02710721|"~     The aim of this trial is a first evaluation of the effectiveness of intermittent fasting as a~     supplementary therapy in patients with CRPC or hormone-sensitive prostate cancer with high~     metastatic load (1≥ visceral and ≥4 osseous metastases) in respect to quality of life,~     reduction of side effects and possible reduction in tumor progression.~   "
65418|NCT02710708|"~     The primary objective is to assess the safety profile of YAZ in Chinese women, including~     adverse drug reactions (ADRs).~      The secondary objectives are to investigate the rate of unintended pregnancies, the cycle~     control for subjects with and without preceding abortion, the bleeding pattern of subjects~     with and without preceding abortion (including the abortion-related bleeding pattern) and the~     efficacy in moderate acne vulgaris.~      Another objective is to investigate the effect on dysmenorrhea.~   "
65419|NCT02710695|"~     Each day orthopaedic surgeons worldwide treat patients with musculoskeletal pain. But little~     evidence exists about orthopaedic patient understanding of the common methods of managing~     musculoskeletal pain. Therefore, it is our aim to determine which discussion method best~     improves patient comprehension of common methods of managing pain.~   "
65420|NCT02710682|"~     Lateral epicondylosis, also called tennis elbow or lateral epicondylitis, is a prevalent,~     painful syndrome of the elbow. It is refractory to conservative treatment measures, including~     rest, excentric and concentric exercises in approximately 20% of patients after 6 months.~     Corticosteroid injections can provide relief in the short term. Mini-open surgery may be~     proposed when the conservative treatment fails and studies have shown an efficacy of 70%.~     Ultrasound-guided tendon fenestration is a minimally-invasive technique which stimulates the~     physiological healing mechanisms of the tendon and appears promising for the treatment of~     chronic tendinopathies. To our knowledge, no studies have compared the US-guided fenestration~     technique to mini-open surgery for the treatment of chronic lateral epicondylosis.~      The primary objective of this pilot study is to compare the efficacy of US-guided~     fenestration to mini-open surgery to reduce pain and improve functional status in workers~     suffering from chronic lateral epicondylosis refractory to 6-month conservative treatment.~      This is a prospective single-blind randomized pilot study. Sixty-four subjects will be~     randomized into two intervention groups for treatment either by US-guided fenestration or~     mini-open surgery. The primary outcome of the study will be the Patient Rated Tennis Elbow~     Evaluation (PRTEE) score at 6 month post-procedure.~   "
65421|NCT02710669|"~     Propafenone is a currently used medicine to treat atrial fibrillation and is a mixture of two~     compounds, (R)-propafenone and (S)-propafenone. In this study, the investigators will~     randomize participants to (R)-propafenone, (S)-propafenone, or placebo.~   "
65422|NCT02710656|"~     A randomized multicentric study for endovascular treatment of patients with obstructive~     disease in the SFA (superficial femoral artery) and in the popliteal artery.~   "
65423|NCT02710643|"~     Phase II prospective multicenter study for stage I/II Follicular Lymphoma treated with~     involved-field radiotherapy (IFRT) at doses of 24 Gy) with or without Ofatumumab for 8 weekly~     doses on molecular basis. Patients with positive basal Bcl-2 will be followed every 3 months~     and with Bcl-2 detection every 6 months for 3 years. Patient with negative basal Bcl-2 will~     be followed every 3 months without further Bcl-2 detection.~      Ofatumumab treatment will be administered to:~        1. Patients with positive basal PCR for Bcl-2-IgH rearrangement in BM and/or PB, resulting~          still positive after IFRT;~        2. Patients with positive basal PCR for Bcl-2-IgH in~   "
65424|NCT02710630|"~     The primary objective of this trial is to investigate the relative bioavailability of five~     different tablet formulations of Dabigatran Etexilate, Formulation A1, Formulation B1,~     Formulation C1, Formulation D1, and Formulation E1, compared to commercial capsule~     formulation of Dabigatran Etexilate.~      The secondary objective is to evaluate and compare several pharmacokinetic parameters between~     the treatments.~   "
65425|NCT02710617|"~     The objective of this study is the evaluation of system accuracy following ISO 15197:2013~     (E), clause 6.3 in which accuracy requirements and applicable test procedures for blood~     glucose monitoring systems intended for self-monitoring of blood glucose by patients are~     stipulated.~      However in this study, system accuracy evaluation will be performed for Hemocue Glucose 201+~     and Hemocue Glucose 201 RT which are both glucose monitoring systems for professional use~     only on behalf of the IDT with one reagent system lot for each BGMS.~      Main goal is the evaluation of system accuracy of both of the hemocue Systems. (english)~   "
65426|NCT02710604|"~     This is a phase 2a study to evaluate the safety and tolerability of multiple oral doses of~     CMX157 at increasing dose levels.~   "
65427|NCT02710591|"~     In Duchenne Muscular Dystrophy (DMD) there is an imbalance between the levels of calcium and~     sodium in the muscles cells which is thought to be important in the damage which occurs~     overtime. Sodium/proton type 1 exchanger (NHE-1) inhibition is an innovative pathway that has~     proved to efficiently prevent the accumulation of muscle damage (inflammation and fibrosis)~     in animal models of muscular dystrophies and heart failure. Based on prior safety and~     efficacy results in animal and humans, NHE-1 inhibition with Rimeporide represents a new~     therapeutic approach with no restriction on age and on genetic subtypes which could be~     combined to other treatments that restore or augment dystrophin.This study examines the~     safety and tolerability and effects on the muscles of rimeporide, in patients aged 6 to 14~     years with Duchenne Muscular Dystrophy (DMD).~   "
65428|NCT02710578|"~     Given the known driving behavior of Driving Under the Influence of Alcohol and some of its~     parallel to driving under the influence of cannabis, this supplemental study aims to validate~     the sensitivity of the primary and secondary outcome measures employed in a cannabis and~     driving study currently in progress.~   "
65429|NCT02710565|"~     Participants who are scheduled to have an endo bronchial ultrasound (EBUS) trans bronchial~     needle aspiration (TBNA) will provide additional samples. These samples will then be sent to~     Imperial College London to see whether a cell line can be grown.~      If growth is successful then the samples will be returned to our pathology department to see~     if grading is possible and then to compare these results with the previous diagnostic~     samples.~      The cell line samples will not be used for patient diagnosis.~   "
65430|NCT02710552|"~     The aim of the study is to compare the efficacy and safety of low-dose combination of three~     antihypertensive drugs versus fixed high-dose combination of two antihypertensive drugs in~     arterial hypertension~   "
65431|NCT02710539|"~     Randomized comparison of once-daily fixed combiNation versus free-drug combination of three~     antihypertensive agents in arterial hypertension~   "
65432|NCT02710526|"~     Phase II, open label, randomized, two treatment group study designed to evaluate the steady~     state pharmacokinetics of buprenorphine and norbuprenorphine following repeated subcutaneous~     administrations of CAM2038.~   "
65433|NCT02710513|"~     The purpose of this study is to evaluate the healthy properties of a dietary intervention~     based on an innovative pasta enriched with prebiotic fibers (barley beta-glucans).~      The hypothesis is that the gut microbiota and metabolome, the nutritional status, the~     redox/subclinical inflammation parameters and the markers of cardiovascular risk may improve~     in healthy subjects.~   "
65434|NCT02710500|"~     The proposed clinical trial is a double-blind, randomized controlled study with direct~     intramuscular injection of rAAVrh.74.MHCK7.DYSF.DV gene vector to the extensor digitorum~     brevis muscle (EDB). Two cohorts of subjects with dysferlin deficiency, each with proven~     mutations will undergo gene transfer. A minimum of three subjects will be enrolled into each~     cohort.~   "
65435|NCT02710487|"~     Sleep benefit (SB) is a prominent spontaneous, apparently unpredictable, transitory~     improvement in motor function reported by around 50% of patients affected by Parkinson's~     Disease (PD) after sleep and before taking their first dose of dopaminergic medications. The~     aim of this study is to test the hypothesis that objective and/or subjective improvement of~     motor function might be due to a carry-over effect of Rapid Eye Movements (REM) sleep at~     awakening from this sleep phase.~   "
65436|NCT02710474|"~     The purpose of this study is to compare neurodevelopment and activity in infants born very~     preterm (26 to 33 6/7 weeks gestational age (GA)) receiving Standard Care (SC) or Family~     Nurture Intervention (FNI) in the neonatal intensive care unit (NICU).~      The study investigator hypothesizes that FNI will improve: i) neonatal~     electroencephalographic activity ii) maternal caregiving and wellbeing (psychological and~     physiological), and iii) infant behavior and neurodevelopment at 18 months corrected age~     (CA).~      The two-part study aims to:~        -  Part I - replicate efficacy from an earlier trial by conducting the study at multiple~          sites to allow for greater generalizability.~             -  SC, approximately 90 infants plus the parents~             -  FNI, approximately 90 infants plus the parents~             -  Term Controls, approximately 25 infants plus the parents - if enrollment not~               reached, enrollment may continue in Part II~        -  Part II - examine effectiveness by implementing FNI unit-wide so that every baby~          receives the intervention.~             -  FNI, approximately 90 infants plus their parents~   "
65437|NCT02710461|"~     The aim of this is study is to evaluate the acute effect of grape and pomegranate polyphenols~     in the modulation of markers of metabolic syndrome. Most of the previous works about~     polyphenols have only considered a fraction of polyphenols, i.e., extractable polyphenols. As~     a consequence, an important amount of dietary polyphenols, the so-called non-extractable~     polyphenols are ignored. In contrast, the effect of both extractable and non-extractable~     polyphenols will be considered in this study. Furthermore, the effect of both polyphenols as~     present in the food matrix and metabolites derived from microbial fermentation will be~     evaluated.~   "
65438|NCT02710448|"~     The study is to treat metformin dose-escalation diabetic subjects of all stages of renal~     failure (stages 1-5) and compare their rates of erythrocyte metformin (best reflections of a~     possible accumulation than those of plasma) to the therapeutic range. A number of 12 patients~     by stage is considered, 60 patients in total.~   "
65439|NCT02710435|"~     The purpose of this study is to collect long term data of the Neovasc Reducer System in~     subjects with refractory angina pectoris.~   "
65440|NCT02710422|"~     The use of dehydrated human amnionic membrane allograft improves erectile function recovery~     (as measured by (Sexual History Inventory for Men (SHIM) score) at 12 months after robotic~     assisted radical prostatectomy (RARP) compared to a control group with no allograft.~   "
65441|NCT02710409|"~     Influenza is an acute respiratory disease caused by influenza viruses. There are three types~     of the virus including A, B and C. Both type A and type B viruses can cause acute febrile~     respiratory tract infection, characterized by sudden fever, headache, muscle pain, cough,~     sore throat, nasal congestion and general malaise. The main transmission of influenza is~     through those highly contagious aerosol droplets containing influenza virus passed from~     infected people to susceptible population. Each year in the fall and winter infection of~     influenza is widespread in various age groups, with high incidence rate. Although influenza~     is generally a self-limiting disease, but in children, the elderly (especially those above 65~     years old and those with chronic heart, lung, kidney, liver, blood or metabolic diseases such~     as diabetes or other certain diseases) and those with poor immunity function, influenza can~     easily lead to serious flu complications such as pneumonia, resulting in severe increase of~     morbidity and mortality.~      In order to evaluate safety and immunogenicity of a quadrivalent influenza vaccine produced~     by Jiangsu Jindike Biotechnology Co., Ltd. a phase III clinical trial is planned to conduct~     in healthy Chinese subjects aged 3 years and older.~   "
65442|NCT02710396|"~     The primary objective is to determine if mutation load underlies sensitivity to pembrolizumab~     alone and in combination with chemotherapy.~   "
65443|NCT02710383|"~     Development of a new MS-based biomarker for the early and sensitive diagnosis of a cystic~     fibrosis disease from plasma~   "
65444|NCT02710370|"~     The purpose of this research study is to determine how gastric bypass surgery effects~     metabolism in obesity and Type 2 Diabetes. One mechanism that has been investigated in animal~     models is change to the biology of the small intestine (Roux limb) and how glucose and other~     fuels are metabolized (or how the body digests and uses sugar and other fuels). This study~     will evaluate the role of the intestine in the beneficial metabolic effects of gastric bypass~     surgery. It specifically will examine whether the intestine increases its metabolism and its~     activity, and whether this results in an increase in fuel utilization. Thirty two (32)~     subjects will be recruited (18 with and 14 without Type 2 Diabetes). At the time of gastric~     bypass surgery, a small piece of intestine that is usually discarded will be collected. At~     three time points over the first year after surgery, intestinal samples will be obtained by~     endoscopy or insertion of a lighted flexible tube through the mouth. Blood samples will be~     taken at all time points, as well. All samples will undergo comprehensive metabolic analyses.~     Comparisons will be made between the two groups to understand the metabolic changes over time~     and if there are differences between the two groups.~   "
65445|NCT02710357|"~     The aim of this study is to assess the cost-effectiveness of the mandibular overdenture~     retained by a single implant. The study hypothesis is that SIMO is more effective but more~     costly than the conventional denture, though this incremental cost is relatively low for the~     offered effectiveness in terms of clinical and patient-reported outcomes.~   "
65446|NCT02710344|"~     The overarching aim of this study is to evaluate whether telehealth leads to better mental~     health outcomes and decreased use of acute and crisis-based mental health care services by~     randomly assigning 300 people with serious mental illness (SMI) and psychiatric instability~     receiving services at 1 of 2 community mental health centers (CMHCs), each of which offers~     integrated behavioral and primary health care, to either Health Home Usual Care alone or~     telehealth plus Health Home Usual Care for 12 months, with assessments at baseline, 3, 6 and~     12 months.~   "
65447|NCT02710331|"~     The overarching goal of this study is to characterize the effects of ethanol and cannabinoids~     on simulated driving and related cognition.~   "
65448|NCT02710318|"~     Immunization is one of the most effective public health interventions. Yet, nationally~     coverage has consistently fallen short of national goals, and has remained for the most part~     stagnant. The continued presence of vaccine-preventable diseases poses a threat to public~     health. In addition to needed improvement of immunization coverage for the general~     pediatric/adolescent population, some children with chronic medical conditions need specific~     additional immunizations, yet many fail to receive them.~      Immunization reminders for providers in the electronic health record (EHR) are a type of~     clinical decision support (CDS) that can reduce missed immunization opportunities. One~     limitation of these reminders is that they generally depend only on data local to the EHR,~     which can be incomplete due to record scatter, leading to inaccurate alerts. An Immunization~     Information System (IIS), also known as an immunization registry, is a population-based~     system that collects immunization data primarily for children and adolescents from providers~     at a regional or state level.~      The investigators seek to couple bidirectional exchange of IIS immunization information and~     forecasting tools with patient level medical history from the EHR to deliver accurate,~     patient-specific EHR immunization reminders.~   "
65449|NCT02710305|"~     hysterosalpingography is a diagnosis procedure in the evaluation of infertile women and~     considered to be the traditional and the gold standard in the assessment of the patency of~     the fallopian tubes. The major disadvantage of hysterosalpingography is pain. In a study~     reported the patients complained of moderate to severe pain during the procedure. It is~     reported that some patients undergoing hysterosalpingography was more stressful and anxiety~     and effect on pain scores.~   "
65450|NCT02710292|"~     The purpose of this study is to compare DAILIES TOTAL1® (DT1) to 1-DAY ACUVUE® TruEye® (TE)~     for Investigator-rated successful lens centration in Japanese population.~   "
65451|NCT02710279|"~     Suicide is a major health problem that causes annually a million death worldwild. In the~     stress-vulnerability model, suicidal behavior (SB) results from the interaction between an~     individual's predisposition and stressful condition. We hypothesized that the sensitivity to~     social exclusion may represent a core component of the suicidal vulnerability Recent evidence~     also suggest that inflammatory mediators plays a critical role in SB. Furthermore, social~     stressors are particulary strong and specific triggers of inflammatory response.~      To sum up, patients carrying a suicidal vulnerability are expected to present greater~     responses to social rejection in terms of inflammatory activity and psychological pain.~      The aim of the study is to evaluate the psychological and inflammatory responses to a social~     stressor validated, the Trier Social Stress Test (TSST) . We will also investigate the~     moderating effect of childhood abuse, attachment, trait rejection sensitivity and social~     isolation.~      In the second part of the study, we will also investigate the prospective association between~     inflammatory responses induces by laboratory paradigms of social rejection and the occurrence~     of social distress, suicidal ideation and psychological pain in response to social exclusion~     events in real life (using ecological momentary assessment).~   "
65452|NCT02710266|"~     Liver resection have been a primary treatment option for lesions found in the liver. With~     improvements in surgical technique and perioperative patient management, morbidity and~     mortality related to liver resection have been greatly reduced. However, many patients with~     hepatocellular carcinoma have underlying liver disease. Severity of underlying liver disease~     plays an important role in decision making of resection extent. Therefore, liver failure and~     decreased liver function following liver resection still remains to be an critical issue.~      Postresection liver failure is generally defined by serum total bilirubin greater than 3mg/dL~     and prothrombin time of less than 50% of normal (INR >1.7). Pathophysiology of postresection~     liver failure is not yet well known. However, sepsis after liver resection, small-for-size~     syndrome (SFSS), and ischemia/reperfusion injury are known to have important roles in~     persistant liver injury after resection.~      After a liver resection, kupffer cells are drastically decreased and innate immunity of the~     patient is also damaged. This process causes the patient to be vulnerable to infection. In~     addition, with continuous endotoxin secretion, dysfunction in kupffer cells are triggered and~     liver regeneration is affected.~      Complex mechanisms leading to dysfunctional kupffer cells and apoptosis and necrosis of~     hepatocytes are mediated by neutrophils, complement, reactive oxygen species, and acute~     inflammatory cytokines.~      Recent studies have reported on many promising effects of the synthetic protease inhibitor,~     such as Gabexate mesilate. These include antioxidant effect, inhibition of acute inflammatory~     cytokine reaction, and anticoagulatory property. Based on these effects, synthetic protease~     inhibitor have gained attention in the role of hepatocyte protection after liver resection.~      Currently, there is a report on the hepatocyte protective effects of Gabexate Mesilate on~     ischemia/reperfusion injury caused by the Pringle maneuver. However, with the advances in~     surgical technique and equipment, many surgeons now perform liver resection without Pringle~     maneuver. Therefore, this study was designed to determine effects of Gabexate Mesilate in the~     liver resection performed without Pringle maneuver.~   "
65453|NCT02710253|"~     The goal of this clinical research study is to learn if using radiation therapy can help to~     control the cancer after the disease has gotten worse after receiving immunotherapy.~      This is an investigational study. Radiation therapy is delivered using FDA approved and~     commercially available methods. It is considered investigational to use radiation therapy in~     patients whose disease has gotten worse after receiving immunotherapy.~      The study doctor can explain how radiation therapy is designed to work.~      Up to 150 participants will take part in this study. All will be enrolled at MD Anderson.~   "
65454|NCT02710240|"~     A specific aim is to determine if Indocyanine Green (ICG) administered pre-operatively, then~     imaged intraoperatively using our camera will aid in the identification of suspected central~     nervous system (CNS) tumors. A secondary aim is to understand if the use of ICG during~     surgery correlates to MR imaging findings including elevated Cho/Cr ratio, rCBV, Ktrans and~     contrast enhancement.~   "
65455|NCT02710227|"~     Individuals with hepatic cirrhosis (n=50) and healthy controls (n=30) were recruited. Sleep~     quality, sleep timing parameters and circadian preference were evaluated using the Pittsburgh~     Sleep Quality Index (PSQI), Sleep Timing Questionnaire (STQ) and The Composite Scale for~     Morningness (CSM) respectively~   "
65574|NCT02708680|"~     The purpose of this study is to determine the safety and tolerability of entinostat used in~     combination with atezolizumab in patients with Advanced Triple Negative Breast Cancer~     (aTNBC). Additionally the purpose of the study is to assess how effective entinostat and~     atezolizumab are in combination in patients with aTNBC.~   "
65456|NCT02710214|"~     Duavee is a hormone receptor modulator that has been approved for the treatment of menopausal~     symptoms in menopausal women. The goal of this 8-week randomized, double blind, placebo~     controlled pilot study, is to determine whether this medication alleviates menopausal~     symptoms in women with MS. The investigators will secondarily determine whether addressing~     menopausal symptoms ameliorates MS symptoms and, on MRIs, is not triggering worsening~     inflammation.~   "
65457|NCT02710201|"~     Objective: Physical activity confers numerous health benefits, yet few adults meet~     recommended physical activity guidelines. The impact of brief messages providing feedback on~     physical activity was tested in this study. Methods: Young adults were randomly assigned to~     one of three conditions: (1) feedback on how active others were, (2) feedback on how active~     others were plus a message of approval or disapproval depending on whether the participant~     was more or less active than average, or (3) no feedback (control condition). Participants~     used pedometers for eight weekdays and recorded their step counts each evening. The group~     receiving feedback on how active others were got information about the average number of~     steps taken by group members the previous day. The group that also received approval or~     disapproval received feedback about the group average, as well as a sad face if the~     participant was below the average or a happy face if the participant was above the average.~     The control group received no feedback throughout the study. Impacts of these feedback~     messages were compared on number of steps taken during the study.~   "
65458|NCT02710188|"~     The purpose of this study is to find a modified release oral tablet formulation for this~     drug, which will be safe and well tolerated.~   "
65459|NCT02710175|"~     Infertility is defined as the inability of a couple to achieve pregnancy over an average~     period of one year (in women under 35 years of age) or 6 months (in women above 35 years of~     age) of unprotected sexual intercourse. Infertility can be due to female, male reasons or~     both. It can be either primary or secondary.~      Thyroid dysfunction and autoimmune thyroiditis are known adverse risk factors for pregnancy~     as well as fertility, regardless of the presence of disease in women of reproductive age. In~     particular, hypothyroid women are at an increased risk of menstrual disorders and infertility~     because of altered peripheral estrogen metabolism, hyperprolactinaemia and abnormal release~     of gonadotropin-releasing hormone.~      The prevalence of subclinical hypothyroidism characterized by aberrant high serum~     thyroid-stimulating hormone (TSH) levels with normal free thyroxin (FT4) levels in infertile~     women are reported to be approximately 20% and it is a primary cause of subfertility.~      Indeed, average TSH levels in infertile women were reportedly higher than those in normal~     fertile women. And elevated serum TSH levels were associated with diminished ovarian reserve~     in infertile patients. Moreover, although levothyroxine replacement therapy for subclinical~     hypothyroidism in infertile patients remains debatable, thyroxin supplementation may improve~     fertility to successful pregnancy.~      This data suggests that hypothyroidism is strongly correlated with infertility (Velkeniers et~     al., 2013).~      On the other hand, female fecundity decreases with increasing age, primarily because of~     decreased ovarian function. Anti-mullerian hormone (AMH) is a dimeric glycoprotein belonging~     to the transforming growth factor-beta (TGF-B) super family, which act on tissue growth and~     differentiation. It is produced by the granulosa cells from pre-antral and small antral~     follicles. Ovarian research after oophorectomy showed that serum AMH levels were closely~     correlated with the number of primordial follicles; therefore, AMH is a suitable biomarker of~     ovarian age in women of reproductive age.~      Expectedly, ovarian function may be affected by impaired thyroid function, although this~     association has not been elucidated. In this study, we will evaluate the relationship between~     thyroid function and AMH levels by comparing them in infertile patients and healthy fertile~     women.~   "
65460|NCT02710162|"~     Individuals with th Amyotrophic Lateral Sclerosis are at high risk for swallowing impairment~     (dysphagia) which leads to malnutrition, decreased pulmonary health, aspiration and~     aspiration pneumonia. These sequelae necessitate timely identification of at risk individuals~     to ensure optimal management of oral intake and pulmonary function. The purpose of this study~     is to evaluate the discriminant ability of several non-invasive screening tools at detecting~     swallowing impairment in individuals with ALS.~   "
65461|NCT02710149|"~     The main purpose of this study is to explore the therapeutic effect of CD20-targeted chimeric~     antigen receptor T(CAR-T) cells in the treatment of B cell malignancies.~   "
65462|NCT02710136|"~     This research is being done to look at the body's response to cockroach extract, an allergen,~     when sprayed into the nose. The spraying of the cockroach extract into the participant's nose~     is called Nasal Allergen Challenge (NAC). The purpose of this study is to evaluate the safety~     and tolerability of a intranasal cockroach extract given to participants with asthma.~   "
65463|NCT02710123|"~     Adolescents with concussion will be randomly assigned to a treatment group where they will~     receive sub-threshold exercise, or assigned to a placebo group where they will receive~     structured stretching exercises. Both groups will receive standard medical coverage with~     regular clinic visits. All participants will record symptoms daily on a dedicated web site.~     All participants will be evaluated at time 1 with (1) structured physical exam, and (2)~     structured exercise stress test which is terminated when there is symptom exacerbation. The~     primary outcome measure is time to recovery where recovery is defined as (1) asymptomatic for~     two consecutive days, and (2) ability to exercise to exhaustion without exacerbation of~     symptoms, and (3) confirmed by a physician based on a structured physical exam.~   "
65464|NCT02710110|"~     Dysphagia (swallow impairment), dystussia (cough impairment) and respiratory impairment are~     hallmark features of amyotrophic lateral sclerosis (ALS). These symptoms are the cause of~     fatal aspiration, malnutrition and respiratory insufficiency that together account for 91.4%~     of ALS mortality. Unfortunately, treatments to prolong and maintain these vital functions are~     currently lacking. Although the use of exercise in ALS is controversial, recent evidence~     suggests that mild to moderate intensity exercise applied early in the disease slows disease~     progression, improves motor function, preserves motor neuron number, reduces muscle~     hypoplasia, atrophy astrogliosis, and prolongs survival in animal models of ALS and human~     clinical trials.~      This research study is designed to determine the impact of respiratory strength training on~     breathing, airway protection and swallowing in persons with Amyotrophic Lateral Sclerosis~     (ALS).~   "
65465|NCT02710097|"~     The overarching goal of this study is to characterize the effects of ethanol and cannabinoids~     on simulated driving and related cognition.~   "
65466|NCT02710084|"~     This is a pilot study examining the efficacy, safety and tolerability of intranasal oxytocin~     as a novel treatment in Phelan-McDermid syndrome (PMS). This study will utilize a randomized,~     placebo-controlled design for 12 weeks (phase 1), followed by an open-label extension for 12~     weeks (phase 2). The purpose is to evaluate the effect of intranasal oxytocin on impairments~     in attention, social memory, socialization, language, and repetitive behaviors.~   "
65603|NCT02708303|"~     The Mayo Clinic Foregut Surgery Report Card Questionnaire has been created in order to have a~     consistent evaluation tool for patients undergoing foregut surgery in order to standardize~     and validate outcome measures.~   "
65467|NCT02710071|"~     Patients who have obstructive sleep apnea (OSA) frequently stop breathing while they sleep.~     They often develop high blood pressure. We are not sure what drug is best to treat the high~     blood pressure. This study will give the patients nebivolol or hydrochlorothiazide (HCTZ) for~     6 weeks after 2 weeks of placebo. The blood pressure response will be evaluated by 24 hour~     monitoring.~   "
65468|NCT02710058|"~     The investigators are conducting a study entitled 'Experience of Arab American Women with~     Breast Cancer: In-depth Interviews' through which they hope to learn more about Arab women's~     experience with breast cancer.~   "
65469|NCT02710045|"~     The purpose of this study is to investigate for the broad immunological effects of~     administering measles vaccine (MV) and diphtheria-tetanus-whole cell pertussis vaccine (DTP)~     to 9 month old Gambian infants, either alone or together. Effects on vaccine-specific immune~     responses, innate immunity, and immune memory were studied. The hypothesis is that when MV~     and DTP are given together there will be more inflammation and this will interfere with~     generation of immunity to the vaccine and to other non-vaccine related stimuli.~   "
65470|NCT02710032|"~     The investigators propose a social network-based PrEP adherence intervention as part of a~     comprehensive, context-specific approach to HIV prevention for TW in Lima, Peru. In order to~     be effective, PrEP-based prevention strategies need to address not only biological efficacy,~     but also individual behavioral decision-making processes, interpersonal partnership contexts~     of risk, peer norms of sexual behavior and PrEP adherence, and structural access to~     prevention technologies. Using a health promotion behavioral model that combines Social~     Action Theory with social network theories of information dissemination and collective~     behavior change, the investigators propose to develop and refine a network-based intervention~     that promotes PrEP adherence in the existing social networks of TW. Formative research will~     outline individual, partner-level, and network-based contexts of sexual risk behavior,~     patterns of social network interactions, anticipated adoption and use of new prevention~     technologies, and optimal content for a PrEP adherence intervention. Findings will be used to~     define the elements of a prevention intervention using social networks of TW and social media~     technologies to generate, implement, and reinforce social norms of PrEP adherence and risk~     behavior reduction for TW.~   "
65471|NCT02710019|"~     The purpose of this study is to determine whether the Back to Reality series video games -~     Harry's Journey, Harry's Journal, and Pathways to care map - are effective at educating~     homeless and street involved youth, registered at the Youth Services Good Shepherd Hamilton,~     about the emotional, social, and psychiatric sequel of problematic underage substance use.~     The objectives of the video games are to promote early detection and awareness of mental~     health and substance use problems among youth.~   "
65472|NCT02710006|"~     The purpose of this trial is to evaluate the feasibility and reliability of automatic volume~     calculation of uterine cavity in women with reproductive failures. 3D volumes of uterus and~     uterine cavity will be acquired during three-dimensional ultrasonography and~     sonohysterography. After that independent observers will measure offline the uterine cavity~     volume using automatic volume calculation using SonoAVC general software, and VOCAL software.~   "
65473|NCT02709993|"~     The purpose of this study is to determine the safety and efficacy of Tumor Associated Peptide~     Antigen (TAPA) pulsed dendritic cell (DC) vaccines in the treatment of hematologic~     malignancies.~   "
65474|NCT02709980|"~     The current study seeks to evaluate cognitive behavior therapy for insomnia (CBT-I), a~     non-medication treatment, in recent TBI patients compared to a sleep education control~     intervention. Patients will participate in CBT-I treatment (or sleep education treatment)~     weekly for six weeks, and will have a 3-months follow-up visit in order to examine the~     efficacy and time course of treatment. In addition, participants will complete several~     self-report questionnaires in order to examine sleep and neuropsychiatric symptoms throughout~     treatment.~   "
65475|NCT02709967|"~     Background Adolescent pregnancies carry risks to the young mothers and the baby. Keeping~     girls in school can potentially protect girls from getting pregnant. In Zambia, 35% of young~     rural girls have given birth by the age of 18 years, and the pregnancy rates are particularly~     high among girls who are out-of-school. Approximately 50% of girls never enroll in secondary~     school. Widespread myths and negative social norms are barriers to adolescent girls using~     modern contraceptives, thus contributing to high rates of early pregnancy. However, there is~     little robust research from Africa on how sexual and reproductive health programmes can be~     delivered in a way that actually affects early marriage and pregnancy rates.~      Purpose To measure the effect on early childbearing rates in a rural Zambian context of (1)~     economic support to girls and their families, and (2) combining economic support with a~     community intervention to enhance knowledge about sexual and reproductive health and~     supportive community norms~      Design Cluster randomized controlled trial with three arms with clusters being rural basic~     schools (With grades 1-9) with surrounding communities.~      Study population The participant population will be girls enrolled in grade 7 in January in~     2016 in rural schools in twelve study districts: Kalomo, Choma, Pemba, Monze, Mazabuka,~     Chikankata, Kapiri Mposhi, Kabwe, Chisamba, Chibombo, Mkushi, and Luano.~      Study size Approximately 5000 girls and 157 clusters, that is 1000 girls and 31 clusters in~     the control arm and 2000 girls and 63 clusters in each of the intervention arms. The~     rationale for having different numbers of clusters is that we expect larger differences~     between each of the intervention arms and the control arm than between the two intervention~     arms themselves.~      Intervention One intervention arm will be offered economic support in the form of monthly~     cash transfers to the participating girl and her parents and payment of school fees in 2017~     and 2018 if the girl attends junior secondary school. The second intervention arm will be~     offered the same economic support combined with a community component comprising community~     meetings about the value of education for adolescent girls and the risks related to early~     childbearing, and a youth club for girls and boys (both in- and out-of-school).~   "
65476|NCT02709954|"~     The overarching goal of this study is to characterize the effects of ethanol and cannabinoids~     on simulated driving and related cognition.~   "
65477|NCT02709941|"~     The purpose of the current study is to investigate the effects of a novel breathing training,~     called inspiratory muscle strength training (IMST), on sleep patterns, breathing and blood~     pressure for patients diagnosed with mild, moderate and severe sleep apnea.~   "
65478|NCT02709928|"~     Multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and~     pharmacodynamics of TD-0714 in healthy adult and elderly subjects~   "
65479|NCT02709915|"~     This study is undertaken to explore in patients with uncontrolled T2D treated with insulin,~     whether a diet with large breakfast and lunch with small dinner (Bdiet) will enhance CG~     expression and will be more effective for weight loss and for achieving glycemic control and~     reduction of total daily insulin dose compared to an isocaloric diet with 6 small meals~     distributed evenly along the day~   "
65480|NCT02709902|"~     Bioequivalence with Clinical Endpoints.~   "
65481|NCT02709889|"~     To assess the safety and tolerability of rovalpituzumab tesirine in subjects with specific~     delta-like protein 3-expressing advanced solid tumors.~   "
65483|NCT02709863|"~     This study will compare the effects of sevoflurane, desflurane and total intravenous~     anaesthesia on pulmonary function tests in patients undergoing endoscopic endonasal~     transsphenoidal surgery of pituitary gland. Participants will be divided into three equal~     groups. The first group will receive sevoflurane, second grup will receive desflurane and~     third grup will receive total intravenous anaesthesia. Investigators are also going to~     evaluate blood gas analysis.~   "
65484|NCT02709850|"~     The purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of~     IONIS ANGPTL3-LRx (ISIS 703802) given to healthy volunteer subjects with elevated~     triglycerides and subjects with familial hypercholesterolemia.~   "
65485|NCT02709837|"~     This project aims at assessing~        -  the impact of heat treatment on the bioavailability of meat carnosine and amino acids,~        -  the interaction between masticatory efficiency and heat treatment of meat on the~          bioavailability of carnosine and amino acids~        -  the effect of dietary calcium on tomato lycopene bioavailability.~   "
65486|NCT02709824|"~     Dental staining is the most common local side effect of chlorhexidine (CHX) mouthwashes.~      A prospective, cross-over, randomized clinical trial will be carried out in triple blind to~     compare the effect on dental staining of two 0.12% CHX mouthwashes: with or without~     anti-discoloration system (ADS). Twenty-two healthy subjects will be enrolled. Briefly, the~     study includes two sequential stages: in the first phase, the immediate objective and~     subjective evaluation of dental discoloration by spectroscopic and questionnaire-based~     analyses will be recorded, at baselines and after each 21-days-long cycle of mouthwash. A~     wash-out period between the cycles of 21 days will be performed.~      In the second phase, a long-term (after 6 months) subjective evaluation of dental~     discoloration will be obtained by means of clinical photograph visual analysis and new~     questionnaires.~   "
65487|NCT02709811|"~     Electrochemotherapy (ECT) is a non-thermal tumour ablation modality. It consists of the local~     potentiation, by means of local reversible electroporation of tumour tissues, of the~     antitumor activity of non-permeant or poorly permeant anticancer drugs already possessing~     intrinsic cytotoxicity. ECT has proved to be effective in the treatment of various cutaneous~     tumour nodules of any origin. Mostly ECT is offered to patients in case of multiple cutaneous~     metastases, when they cannot be excised, due to their number or localization. This study~     investigate the application of ECT in the treatment of liver metastases from colorectal~     adenocarcinoma, for which other thermal cytoreductive methods would be risky compared to the~     supposed expected clinical benefits.~   "
65488|NCT02709798|"~     The purpose of this study is to evaluate whether perioperative use of Shenfu Injection could~     reduce myocardial injury (enzymatic infarct size and infarct volume according to cardiac~     magnetic resonance imaging) in patients with STEMI after primary PCI~   "
65489|NCT02709785|"~     The aim of this study is to provide evidence on the clinical efficacy of SmartMouth Advanced~     Clinical Formula mouthrinse in comparison to the efficacy of 0.12% chlorhexidine mouthrinse~     and a placebo mouthrinse. The placebo will be provided by the sponsor and will be identical~     to SmartMouth ACF (Advanced Clinical Formula), except it will not contain cetylpyridinium~     chloride, zinc chloride and sodium chlorite. The primary outcomes include measures of plaque~     and gingivitis. Secondary outcomes include evaluation of tooth discoloration, taste~     perception, malodor and calculus.~   "
65490|NCT02709772|"~     10 Clinics within Stanford Health Care are randomized to receive or not receive provider~     alerts for 5 commonly overused tests and treatments.~   "
65491|NCT02709759|"~     The purpose of the present study is to conduct a fully-crossed 2 X 2 X 2 factorial randomized~     controlled trial with a diverse sample of 224 MSM recruited from 2 urban HIV primary care~     clinics (one in the Northeast and one in the South). The first study factor will compare~     brief advice (BA) vs. a motivational intervention (MI) that contains detailed personalized~     normative and HIV-specific feedback. The second factor compares an interactive text messaging~     (ITM) intervention vs. no text messaging. The final factor compares intervention of low~     intensity and duration (two sessions over 1 month) to extended intervention (EI) entailing 5~     sessions over 9 months.~   "
65492|NCT02709746|"~     Evaluating the efficacy of vortioxetine 10 mg/day and 20 mg/day versus placebo on depressive~     symptoms in adolescents (age ≥12 and ≤17 years) with a DSM-5™ (Diagnostic and Statistical~     Manual of Mental Disorders, 5th edition) diagnosis of Major depressive disorder (MDD).~   "
65493|NCT02709733|"~     The loss of motivation has emerged as a critical symptom in schizophrenia that is~     consistently linked to functional disability for affected individuals. Despite advances in~     treatment, there have not emerged any effective treatments for this loss of motivation, which~     ultimately hinders our ability to promote recovery for individuals with schizophrenia. To~     address this critical unmet therapeutic need, this study aims to investigate a novel~     computerized motivation rehabilitation program using virtual reality to treat motivation loss~     in schizophrenia.~   "
65494|NCT02709720|"~     Phase II clinical trial with metronomic oral vinorelbine and tri-weekly cisplatin as~     induction therapy and subsequent concomitantly with radiotherapy (RT) in patients with lung~     cancer (NSCLC) locally advanced unresectable~   "
65495|NCT02709707|"~     Evaluation of the iGlucose Blood Glucose Monitoring System in the hands of lay users~   "
65511|NCT02709499|"~     Cardiovascular diseases are the leading causes of morbidity and mortality in Brazil and~     surgical procedures to treat these disorders have grown dramatically in recent years. Since~     the first heart surgery in successful open field in humans, conducted in 1953 by John Lewis,~     many techniques have been used to improve the outcome of surgery and reduce their side~     effects. The low-level laser therapy (LBP) has been widely used in clinical practice for pain~     relief purposes, reducing inflammation and stimulating tissue healing. However, the effect of~     this therapy has been little elucidated in patients with cardiac disease. The objective of~     this study is to evaluate the effect of low level laser therapy on the inflammatory profile~     and cardiac tissue healing markers of patients in the postoperative period of CABG surgery.~   "
65617|NCT02708121|"~     This pilot trial will test feasibility and acceptability of a primary care-based intervention~     that aims to increase the portion of patients who enter evidence-based behavioral weight loss~     treatment.~   "
65618|NCT02708108|"~     This study tests the ability of a focused dietary, exercise, and activity intervention to~     reduce fat gain during induction therapy for childhood acute lymphoblastic leukemia to~     improve disease response and reduce toxicity.~   "
65496|NCT02709694|"~     In patients with Crohn's Disease, symptoms of inflammatory back pain (IBP) precede changes on~     plain X-rays by years, and MRI changes of axial inflammation precede development of X-ray~     changes. Sacroiliitis on MRI without x-ray changes (i.e.Non radiographic SpA) is a valid~     diagnostic criterion for Spondyloarthritis (SpA) and leads to earlier diagnosis of SpA in~     patients with IBP. It is unclear when MRI changes occur, and if they precede clinical~     symptoms of IBP. There are reports of asymptomatic sacroiliitis noted on MRI in Crohn's~     patients. This is important, as MRI evidence of inflammation may be the first sign of~     incipient SpA. Inflammation in other regions of the axial skeleton in SpA patients has also~     been documented, but its significance is unknown. The prospect of undiagnosed and untreated~     inflammation is concerning, as it can lead to significant morbidity. Moreover, relationship~     between MRI evidence of axial inflammation-likely a proxy for systemic inflammation- and~     patient reported outcomes (e.g. ASDAS-CRP= Ankylosing Spondylitis Disease Activity Score- C~     reactive protein, BASDAI= Bath Ankylosing Spondylitis Disease Activity Index, SF-12 = Short~     Form- 12, HBI= Hervey Bradshaw Index and PROMIS-29= Patient Reported Outcome Measurement~     Information System-29), has not been reported. Recent unpublished data from Dr. Longman's lab~     (collaborator) suggest a distinct intestinal dysbiosis in Crohn's associated SpA. But~     relationship between this microbiome and MRI changes is yet to be determined.~      Identifying inflammation earlier on MRI- in the absence of clinical symptoms will provide an~     opportunity to intervene early with available therapies, such as- biologics etc. Asymptomatic~     MRI changes could be a marker of underlying systemic inflammation- which is a risk factor for~     poor outcomes in Crohn's associated SpA. Studying association between whole spine MRI changes~     with patient reported outcomes) may facilitate informed clinical decision making to initiate~     targeted therapy to prevent progression of structural damage. Understanding microbial~     dysregulation in this population, and correlation with MRI changes, could lead to development~     of therapy targeted to restore intestinal symbiosis.~   "
65497|NCT02709681|"~     This is a retrospective cohort study of Sickle Cell Disease (SCD) patients attending 32~     treatment centers across Italy. The aim of this study will be to report the Italian~     experience with the use of hydroxyurea in a large cohort of SCD patients and to evaluate the~     benefits and safety of this intervention for the prevention and management of a wide range of~     clinical morbidities~   "
65498|NCT02709668|"~     A randomized double-blind placebo controlled study of reduced B vitamins in patients with~     major depression who were positive for one or both of the common MTHFR polymorphisms was~     conducted between 8/1/2014 and 4/3/2015. Homocysteine levels and MADRS scores were used as~     primary measures. The study was designed to test safety and efficacy of reduced B vitamins in~     MDD associated with MTHFR. This study examines the data from the trial to see effects, effect~     sizes, and further, if demographic factors and other patient characteristics correlated with~     findings.~   "
65499|NCT02709655|"~     Investigation of the efficacy and safety of a new potential treatment of Major depressive~     disorder (MDD) in paediatric patients (age 7 to 11 years)~   "
65500|NCT02709642|"~     The purpose of this study is to determine if a financial deposit contract is a successful~     method of helping people to maintain their weight loss. A deposit contract is an agreement in~     which participants put their own money at risk, with the goal of earning it back by~     achieving a goal, in this case maintaining prior weight loss. The study will also evaluate~     the interventions using survey research to assess the feasibility and acceptability of the~     interventions.~   "
65501|NCT02709629|"~     The current study examines the efficiency of a home-based computerized cognitive training~     (CT) intervention targeting older adults with diabetes.The primary aim of the study is to~     evaluate the effects of CCT on cognitive and disease management in non-demented older~     diabetes adults. Investigators will also evaluate the effect of the intervention on a range~     of secondary outcomes, including mood, caregiver burden, self-efficacy, and for a small~     sub-sample, on brain activity as reflected in changes in task-related blood-flow on fMRI.~   "
65502|NCT02709616|"~     Dendritic cell-based cellular vaccine for tumor therapy has shown efficacy. This study is~     designed to perform a personalized clinical trial by first analyzing the expression of tumor~     associated antigens in patients with newly diagnosed glioblastoma and then immunizing the~     patients with personalized DC-based cellular vaccine. In addition, allogeneic peripheral~     blood mononuclear cells (PBMCs) will be used as cellular vehicle for immunization. Safety and~     efficacy will be observed in the study.~   "
65503|NCT02709603|"~     Many oral analgesic drugs such as nonsteroidal anti-inflammatory drug(NSAID) are used to~     relieve pain from gynecological procedure and dysmenorrhea. Hyoscine-N-butyl bromide, an~     antispasmodic drug are commonly used for relief of smooth muscle spasms and can use to~     relieve genito-urinary spasm. Some studies reported hyoscine can't relieve pain in minor~     gynecological procedures. So the efficacy of hyoscine use are still controversial and no~     previous studies investigated its efficacy for pain relief in HSG procedure.~   "
65504|NCT02709590|"~     The aim of our study is to determine the efficacy of oral diclofenac potassium combined with~     lidocaine cream on the pain scores during HSG.~   "
65505|NCT02709577|"~     The purpose of the study was to evaluate the safety and efficacy of the EndoBarrier~     Gastrointestinal Liner compared to sham control in subjects with Type 2 diabetes.~   "
65506|NCT02709564|"~     The aim of the study is to compare the effectiveness of sublingual administered prostaglandin~     E1 synthetic analogue (misoprostol) 400 microgram versus placebo before myomectomy to~     decrease blood loss during and after the operation.~   "
65507|NCT02709551|"~     Aim of the study is the evaluation of the effects (psychological and physiological) of an~     hrv-biofeedback training, a mindfulness training and a combination of both training methods~     for stress reduction.~   "
65508|NCT02709538|"~     To evaluate the long term safety and efficacy of GSP 301 NS compared to 2 placebo NS~     formulations for the treatment of perennial allergic rhinitis (patients 12 years of age and~     older)~   "
65509|NCT02709525|"~     The aim of this study is to evaluate the effects of hyaluronic acid (HA) on bone healing in~     human dental sockets.~   "
65510|NCT02709512|"~     This is a study of ADI-PEG 20 (pegylated arginine deiminase), an arginine degrading enzyme~     versus placebo in patients with malignant pleural mesothelioma with low argininosuccinate~     synthetase 1 expression. Malignant pleural mesothelioma have been found to require arginine,~     an amino acid. Thus the hypothesis is that by restricting arginine with ADI-PEG 20, the~     malignant pleural mesothelioma cells will starve and die.~   "
65524|NCT02709330|"~     This is a 12-month, widely inclusive, largely virtual, single-center, open-label pilot trial~     utilizing a historical control group. Participants will receive a Lunasin regimen and will be~     asked to register for an account of PatientsLikeMe website, where after the initial in-clinic~     visit, they will be asked to enter specific data.~   "
65619|NCT02708095|"~     The main purpose of this study is to evaluate the efficacy and safety of the study drug known~     as baricitinib in participants with systemic lupus erythematosus.~   "
65620|NCT02708082|"~     Study consists of five visits over a one to three month time period.~   "
65512|NCT02709486|"~     Tanezumab is a monoclonal antibody that binds to and inhibits the actions of nerve growth~     factor (NGF). The Nerve Growth Factor Inhibitor (NGFI) class may offer an important~     breakthrough in the treatment of chronic pain and is under clinical investigation for the~     treatment of pain associated with osteoarthritis or other chronic pain conditions.~      The primary objective of this study is to demonstrate superior efficacy of tanezumab 5 mg and~     2.5 mg administered subcutaneously (SC) every 8 weeks versus placebo at Week 24 in subjects~     with osteoarthritis of the knee or hip. The 2.5 mg dose was shown to provide efficacy~     benefits with a favorable safety profile when administered intravenously in previous Phase 3~     clinical trials. The 5 mg dose is expected to provide added efficacy benefit over the 2.5 mg~     dose based on data from previous studies.~   "
65513|NCT02709473|"~     Rapid sequence induction (RSI) is a well-known procedure to maintain a safe and rapid airway~     in patients especially at risk of aspiration. Propofol and rocuronium are generally used~     agents for RSI. However, the difficult airway scenarios are always valid for these patients,~     even without predictive signs of difficult airway. Therefore, it is important to decrease the~     rocuronium dose used in RSI to achieve a rapid recovery of a neuromuscular conduction with~     the aid of a reversal agent in case of difficult airway. The short acting opioids such as~     remifentanil may be helpful to reduce the dose of rocuronium in RSI.~   "
65514|NCT02709460|"~     Laparoscopic hysterectomy is associated with complications in form of infections and~     subsequently dehiscence of the vault. This is a serious complication. The infection may be~     related to the frequently observed postoperative hematoma following traditional laparoscopic~     hysterectomy where the uterine artery is coagulated and divided at the cervical entry into~     the uterus.~      By coagulation of the uterine artery laterally close to the internal iliac artery this~     problem may be eliminated due to the much less bleeding observed during this procedure.~   "
65515|NCT02709447|"~     Girls in the juvenile justice system are at high risk for dating violence exposure as well as~     co-occurring problems with delinquency and sexual risk taking. Despite the multitude of~     negative outcomes associated with dating violence, no evidence-based preventive interventions~     exist for juvenile justice girls. This study will advance scientific knowledge by testing the~     efficacy of a promising, skills-based intervention (Date SMART) on reducing dating violence,~     delinquency and sexual risk outcomes for a broad range of court-involved, non-incarcerated~     girls.~   "
65516|NCT02709434|"~     Fatigue is a very frequently reported symptom in patients with inflammatory bowel disease~     (IBD), whether it is Crohn's disease (CD) or ulcerative colitis (UC). Sometimes the fatigue~     may be easily explained by other symptoms or tests which show that the disease is active. For~     example patients may be anaemic (have a low blood count) which can in itself lead to a~     feeling of being tired all the time. Treatment of the disease can make some of these patients~     feel less fatigued.~      However, 4 or 5 out of every 10 patients with IBD which is felt to be in remission (ie not~     active disease) report fatigue. This can have far-reaching implications for patients in their~     everyday lives, with issues around work or school, close relationships, travel and leisure~     being profoundly affected. The CCUK funded research on fatigue and IBD, led by Professor~     Christine Norton and Wladzia Czuber-Dochan at King's College London, has identified fatigue~     as being a significant issue facing patients and has also highlighted that few doctors offer~     help and support beyond treating the disease itself when active. This is partly because~     fatigue itself has been difficult to measure and so any study designed to treat fatigue would~     be limited by being unable to quantify any improvement in a meaningful way.~      Fortunately the King's College group have developed a 'fatigue score' which is a simple~     questionnaire that is able to quantify the severity of fatigue. The aim of our study is to~     assess the effect of a structured support and educational programme on the levels of fatigue~     in patients with inactive IBD who report moderate or severe levels of fatigue. A secondary~     component of our study is to see if there are any associations between fatigue levels and~     disease activity or other parameters such as quality of life, anxiety or symptoms of~     overlapping irritable bowel syndrome.~      Patients will be approached in the out-patient or telephone clinics and the study will be~     explained with written information and any questions will be answered. If they agree to being~     involved they will be asked to complete the fatigue and a number of other questionnaires in~     addition to having the standard assessment of symptoms, blood tests and a stool specimen.~     Patients with active disease will be excluded from the subsequent group interventions but the~     data they have provided to this point will still be helpful in our understanding of fatigue~     in IBD. Patients identified as being in remission following the initial assessments will be~     offered the opportunity to be involved in the next stage of the study. The stool samples will~     also be analysed for the microbiome ie which bacteria are present as some studies suggest~     that patients with IBD may have a reduced diversity of bacteria in their intestines.~      Half of this group will be randomised to active intervention and half will act as a control~     group for the rest of the study. The active intervention will involve completion of activity~     diaries over the following two weeks and then analysis of the diaries and agreement on~     behaviour changes designed to help fatigue. This will be supported by written information and~     three, monthly small group sessions to reinforce and support these changes.~      At the end of the study all patients will again complete the fatigue and quality of life~     questionnaires and have their disease activity assessed by symptom scores, blood and stool~     tests. The baseline results and the final results will be analysed to see if there is any~     improvement in fatigue in the group undergoing the programme of support and behaviour change.~      This is only a small pilot study but if it demonstrates that the intervention is feasible and~     may help with fatigue then a larger study will be performed to try and confirm our initial~     findings.~      Our ultimate aim is to find a simple intervention to empower patients to deal with the~     difficult task of living with IBD and the fatigue that this can bring.~   "
65517|NCT02709421|"~     Post-endoscopic retrograde cholangiopancreatography(ERCP) pancreatitis (PEP)remains the most~     frequent adverse event of ERCP. Rectal indomethacin, as one kind of classic NSAIDs, has been~     proved to be effective in reducing the incidence of PEP. It has been widely used to prevent~     PEP in patients, especially those with potentially high risks of PEP. However, rectal~     indomethacin can not completely eradicate the occurrence of PEP. The rate of PEP in patients~     receiving indomethacin ranges from 3.2% to 9.2%. The risk factors of PEP in patients~     receiving rectal indomethacin remains unclear. The aim of the study was to identify potential~     risk factors in high-risk patients whose received administration of prophylactic rectal~     indomethacin after ERCP.~   "
65518|NCT02709408|"~     Among antibiotic-resistant organisms, the Gram-negative bacteria are now the most important~     challenge because of the rapid worldwide spread of mechanisms conferring resistance to~     multiple drugs. The most recent and worrying problem is the emergence and spread of~     carbapenemases. Additionally, carbapenem-resistance is known to be very frequent among~     Acinetobacter baumannii isolates for many years. Overall, the therapeutic options available~     against carbapenem-resistant Enterobacteriaceae (CRE) and A. baumannii (CRAB) are very~     limited. The best available treatment (BAT) against CRE is unknown, which is a challenge for~     therapeutic decisions and also for the design of randomized trials with new drugs. The~     generic objectives of EURECA are to obtain high‐quality observational data to inform the~     design of randomized controlled trials for complicated intraabdominal infections, pneumonia,~     complicated urinary tract infections and bloodstream infections due to Carbapenem-resistant~     Enterobacteriaceae (CRE) and carbapenem-resistant Acinetobater baumannii, and to provide~     cohort data that could eventually be used as historical controls for future comparisons with~     new drugs targeting CRE. This will be achieved by a prospective, multinational cohort study~     of patients with targeted infections due to CRE and CRAB, and by matched case-control-control~     studies.~   "
65519|NCT02709395|"~     This study is designed as an open, prospective, single arm, multicenter study in order to~     investigate patient satisfaction, perception and compliance for the novel Navina Smart, a~     transanal irrigation (TAI) system. Approximately 30 male and female subjects who are~     currently practicing TAI, will be followed during a 4-week period of use of Navina Smart.~     Observational data on satisfaction, perception, compliance, bowel regimen, TAI therapy and~     TAI frequency will be collected via patient reported outcome (PRO) questionnaires.~   "
65520|NCT02709382|"~     This is a Phase 1, open label, single-dose, pharmacokinetic study to be conducted in male and~     female subjects with normal and impaired renal function. The study will be composed of five~     groups of patients with mild (6 patients), moderate (6 patients), severe (6 patients) renal~     impairment, end stage renal disease patients on hemodialysis (6 patients) and their~     respective matched controls in 1:1 ratio (24 healthy subjects with normal renal function).~   "
65521|NCT02709369|"~     The purpose of this study is to explore the functional and physiological effects associated~     with the use of High-resolution, relational, resonance-based, electroencephalic mirroring~     (HIRREM), as supplemental care, for symptoms of neurological, cardiovascular, and~     neuropsychological disorders. This is a non-randomized, open label, and unblinded~     before-and-after trial, evaluating the effect of HIRREM on an objective, physiological common~     denominator (heart rate variability, HRV), across a variety of relevant conditions, as well~     as changes in clinical symptoms inventories, to generate hypotheses and pilot data for~     investigation in future proposals.~   "
65522|NCT02709356|"~     Evaluate and compare the changes in brain ketone and glucose uptake after taking two~     different MCT oil emulsions (60-40 oil or C8 oil) for one month, in a group of people with~     Alzheimer's disease and a control group.~   "
65523|NCT02709343|"~     This study is designed for lung transplant patients who have developed chronic lung allograft~     dysfunction (CLAD). Consented patients will receive 4 intravenous doses of allogeneic,~     bone-marrow-derived MSCs (2*10^6 cells/kg/dose) or matching placebo over a period of 2 weeks~     with a 12 month follow up.~   "
65525|NCT02709317|"~     Veterans who are taking prescription opioids for chronic pain and are engaging in risky~     drinking are at heightened risk for drug interactions, including overdose and other negative~     effects, particularly if they are also using benzodiazepines. In this application, the~     investigators propose to test an integrated prevention intervention, designed to reduce rates~     of risky drinking in veterans receiving prescription opioids to treat their chronic pain.~     This adaptive, patient-centered intervention provides integrated clinical assessment, brief~     intervention, monitoring, and extended prevention services delivered through a combination of~     clinical visits, telephone calls, and text messages. The investigators propose to conduct a~     study in which veterans (N=300) who are on daily doses of prescription opioids and screen~     positive for risky alcohol use will be randomized to receive 12 months of an adaptive~     integrated prevention intervention (IPI) or to standard care (SC), which consists of a Brief~     Intervention (BI) with 2 follow-up contacts. Potential participants will be veterans at the~     Philadelphia VA, and surrounding areas, or the Pittsburgh VA who, based on pharmacy records,~     are using opioids daily to treat chronic pain. An initial evaluation will identify~     individuals who also engage in risky alcohol use based on NIAAA-recommended guidelines and~     meet other inclusion criteria to be enrolled in the study. The evaluation will also identify~     the use of other medications (e.g., benzodiazepines) that could interact negatively with~     opioid use. For veterans randomized to the IPI condition, a BI is first provided to reduce~     alcohol to non-hazardous levels and the effects are monitored for one month. Veterans who~     reduce alcohol use to non-hazardous levels during this one-month period continue in a~     monitoring track, consisting of tailored text messages and brief monthly telephone contacts.~     Veterans who continue to drink at risky levels are instead placed in a track that provides~     tailored text messages and more frequent telephone calls. In addition to monitoring, these~     calls provide further prevention/BI services to help the veteran reduce alcohol use to~     non-hazardous levels. Key components of these services are motivational enhancement and~     development of more effective ways to cope with stress and other triggers for risky alcohol~     use. All participants will be followed up at 3, 6, 9, 12 and 18 months after baseline. The~     primary outcome at each follow-up point will be a dichotomous measure of any risky drinking~     since the prior follow-up (yes/no). Secondary outcomes will include self-reported frequency~     of heavy drinking, biological measures of alcohol use, other drug use as determined by urine~     toxicology tests, opioid overdoses, and ratings of depression and pain. Repeated measures~     analyses will compare the IPI and SC conditions on primary and secondary outcomes assessed~     across an 18-month follow-up. Analyses will also test hypothesized moderation and mediation~     effects.~   "
65526|NCT02709304|"~     This study will evaluate whether lidocaine gel for urinary catheter insertion would decrease~     pain and discomfort associate with Foley catheters upon awakening from general anesthesia in~     the post anesthesia care unit. As a secondary objective, the study will evaluate bacterial~     colony counts from urine obtained from the surgical patients after insertion of the Foley~     catheter prior to prophylactic antimicrobial administration.~   "
65527|NCT02709291|"~     Early childhood disruptive behavior problems lead to significant costs to families and~     society, but can be reduced with behavioral parent training interventions. To increase the~     public health impact of these interventions, their feasibility, accessibility, and~     acceptability in high-need, underserved communities must be ensured. This pilot project will~     systematically adapt and pilot-test the delivery model of an existing effective parent~     training intervention for implementation in rural Appalachia, a region with many documented~     health disparities, high levels of poverty, and shortages of mental health providers.~     Community health workers in 5 rural Appalachian counties will be trained to deliver a~     behavioral parent training intervention. Each worker will deliver the intervention to 4~     parent-child dyads.~   "
65528|NCT02709278|"~     TB041 is a clinical challenge trial primarily to evaluate the safety of BCG challenge~     administered by the aerosol inhaled route in healthy, BCG naive UK adults. The trial will~     also look to evaluate and compare the amount of BCG recovered from the lungs and from the~     skin, following challenge by either the aerosol or the intradermal route.~   "
65529|NCT02709265|"~     This study will evaluate systemic and urine pharmacokinetics in spontaneously breathing~     healthy volunteers following a single dose of amikacin/fosfomycin, using the PARI~     Investigational eFlow Nebulizer System or the PARI LC Sprint Nebulizer. Three doses (30/12~     mg, 60/24 mg, 90/36 mg amikacin/fosfomycin) will be evaluated. Following this evaluation, a~     single dose and nebulizer will be chosen to further evaluate systemic, bronchoalveolar, and~     urine pharmacokinetics in spontaneously breathing healthy volunteers.~   "
65530|NCT02709252|"~     Arterial pulse pressure variation induced by mechanical ventilation (ΔPP) is considered one~     of the best parameter to predict fluid responsiveness in patients under general anaesthesia.~     Pleth Variability Index (PVI) has been proposed as a less invasive alternative. However, the~     pneumoperitoneum has been recently seen suggested as a limitation to their interpretation.~     The aim of this observational study is to compare changes in ΔPP and PVI related to~     autotransfusion associated with a Trendelenburg manoeuver before and during laparoscopy in~     patients undergoing elective surgery.~   "
65531|NCT02709239|"~     The purpose of this study is to learn how much DHA to give to mothers in order to provide~     enough to the baby. Researchers will also learn if there are differences in development of~     the baby up to 12 months after birth.~   "
65532|NCT02709226|"~     Background:~      A glioblastoma is a tumor in the brain. It is treated with surgery, chemotherapy and~     radiation therapy. However, most people s tumors come back after therapy. When the tumor~     grows back, surgery or chemotherapy may not be possible or may no longer work. Repeat~     radiation therapy or re-irradiation, is an option for treating these tumors when they regrow.~      Objective:~      To find out the safety and highest tolerated dose of re-irradiation for people who have~     recurrent glioblastoma.~      Eligibility:~      People ages 18 50 who have glioblastoma that has been treated with radiation but has regrown.~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      MRI of the brain: They will lie in a machine that takes pictures of the brain.~      Participants will have baseline tests before they start therapy. These will include:~      Blood tests~      Neuropsychological tests: These test things like memory, attention, and thinking.~      Quality of life questionnaire~      Eye and hearing tests~      Participants will get a CT of the brain prior to radiation start in order to plan the~     radiation treatment. Once the plan is completed, they will receive radiation once a day~     Monday Friday for a total of 10 17 treatments. They will lie on their back for about 10~     minutes while they get the treatment.~      Participants will be monitored for side effects.~      After they finish treatment, participants will have visits 1, 2, and 3 months later. Then~     they will have them every 2 months for 3 years. These will include:~      Medical history~      Physical exam~      Blood tests~      MRI of the brain.~      Quality of life questionnaire~      Neuropsychological tests (at some visits)~      After 3 years, participants will be contacted by phone each month.~   "
65533|NCT02709213|"~     The aetiologies of computed tomography-diagnosed acute colitis remain surprisingly unknown.~     Moreover, no diagnostic tool or clinical score allow to quickly determine or at least~     stratify the exact cause of colitis in patients admitted at an Emergency Ward and to direct~     them to the appropriate therapeutic care. The aims of the present study are to describe the~     presentation and aetiologies of acute colitis, and to develop diagnostic methods to guide~     patients admitted for acute colitis to the appropriate therapeutic care, particularly~     colonoscopy.~   "
65534|NCT02709200|"~     This is a prospective study looking at the effects of dexmedetomidine on pacemaker function~     in patients who have surgery for congenital heart disease utilizing cardiopulmonary bypass~     (CBP). For the purpose of the study, no change in intraoperative care will be dictated. The~     use of dexmedetomidine will be left up to the discretion of the treating physicians. The~     study will involve only the collection of data regarding the amplitude required to capture~     and specific demographics and intraoperative features including cross clamp time, time on~     CPB, and vasoactive agents that were and are being administered. In addition to these data,~     it will be noted whether dexmedetomdine was used or not and whether it is being administered~     on arrival to the CTICU.~   "
65535|NCT02709187|"~     An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the~     pharmacokinetics characteristics of DP-R208 (Candesartan cilexetil 8mg/Rosuvastatin 10mg), a~     fixed dose combination compared with coadministration of separate constituents in healthy~     adult volunteers~   "
65536|NCT02709174|"~     Objective: To evaluate whether trimester specific d-dimer levels and brain natriuretic~     protein (BNP), along with the modified Wells score (MWS), is a useful risk stratification~     tool to exclude pregnant women at low-risk of pulmonary embolism (PE) from diagnostic imaging~     with radiation exposure.~   "
65537|NCT02709161|"~     The purpose of this study is to determine the clinical efficacy of augmenting~     cognitive-behavioral therapy with real-time functional magnetic resonance imaging~     neurofeedback (rtfMRI-nf) training to increase the amygdala's response to positive~     autobiographical memories.~   "
65538|NCT02709148|"~     The purpose of this study is to use an investigational device to record brain activity for~     12-24 months following surgical implantation of deep brain stimulation (DBS) systems. The~     goal of the study is better understanding of brain activity in Parkinson's disease and how~     they relate to DBS and pharmacological management, not to bring new devices to market.~   "
65539|NCT02709135|"~     Approximately 8-10 million patients complaining of chest pain present to an Emergency~     Department (ED) annually in the United States. These patients are a challenge to healthcare~     providers, who are tasked with determining whether these symptoms are due to an acute~     coronary syndrome (ACS) or a non-ACS cause.In an effort to improve the quality and value of~     care for patients with acute chest pain, our group recently validated a risk stratification~     pathway, the HEART Pathway, which is designed to focus cardiac testing and admissions on~     higher-risk patients, who are more likely to benefit from testing.While the HEART score has~     been well validated in the ED setting, it has yet to be implemented in a prehospital setting.~     Paramedics are often the first providers to evaluate and begin treating patients with~     symptoms concerning for ACS. Current pre-hospital risk stratification is largely based on a~     combination of ECG results and paramedic gestalt. Since ECGs without signs of a STEMI~     (ST-segment elevation myocardial infarction) are poor predictors of ACS, paramedics often~     have difficulty distinguishing high-risk patients from low-risk patients.Thus,~     multidisciplinary leaders within Emergency Medicine, Cardiology, and Prehospital Medicine~     have agreed that a limited/pilot evaluation of the HEART Score with Abbott's i-STAT®~     point-of-care (POC) troponin testing in the prehospital setting is needed. To establish the~     feasibility and accuracy of HEART score and POC testing in the prehospital setting the~     investigators propose a quality surveillance study of a limited implementation of the HEART~     score with POC troponin testing.~   "
65540|NCT02709122|"~     The study aims to determine the level of knowledge and skills to recognize and decompression~     of tension pneumothorax~   "
65541|NCT02709109|"~     The purpose of this study is to evaluate the safety and efficacy of treatment with VX-371 in~     saline compared to saline alone in subjects with cystic fibrosis (CF) who are ≥12 years of~     age, homozygous for the F508del-CFTR mutation, and being treated with Orkambi~   "
65542|NCT02709096|"~     This is a Phase 2a study which is being conducted in healthy volunteers in order to evaluate~     the comparative reduction of Propionibacterium acnes in-vivo following once daily topical~     administration of BPX-01 Minocycline 1% Topical Gel (BPX-01) or BPX-01 Vehicle control.~   "
65543|NCT02709083|"~     This phase II trial studies how well dasatinib, nilotinib, and imatinib mesylate works in~     treating patients with newly diagnosed, previously untreated chronic myeloid leukemia in~     which fewer than 10% of the cells in the blood and bone marrow are blast cells (immature~     blood cells) (chronic phase). Dasatinib, nilotinib, and imatinib mesylate may stop the growth~     of cancer cells by blocking some of the enzymes needed for cell growth.~   "
65544|NCT02709070|"~     There is little evidence showed that adjuvant therapy had been shown to extend the survival~     of patients with hepatocellular carcinoma (HCC) receiving surgical resection. We investigated~     whether injections of highly-purified Cytotoxic T lymphocytes prolongs recurrence-free~     survival of patients after resection for HCC.~   "
65545|NCT02709057|"~     The aim of the study is to compare the effect of lifestyle intervention (diet and physical~     activity) by applying modern approaches to lifestyle changes on the prevention of incident~     T2DM and the worsening of hyperglycemia in people with high number of T2DM risk alleles and~     in people with low number of T2DM risk alleles compared to corresponding control groups.~   "
65546|NCT02709044|"~     The aim of this study is to establish the influence of early administration of a bolus of~     intravascular fluid in patients with a diagnosis of acute pancreatitis on the course and~     outcome of disease.~   "
65547|NCT02709031|"~     Cicletanine, which has been approved and launched for hypertension in France and Germany, has~     promise beyond hypertension in critically-unmet needs such as diabetes. It is evident from in~     vitro, animal and human studies that cicletanine's optimal dose in diabetes and other~     challenging, critically-unmet needs is likely to be higher than that for hypertension.~     Cicletanine's maximum tolerated dosage is not known, but the drug's dose-limiting effects are~     documented to be potassium loss and sodium loss from thiazide-type activity (one of the~     therapeutic mechanisms the drug is known to have); such thiazide-type losses are known to be~     reversed safely by magnesium. This trial explores the ability of magnesium to enhance~     cicletanine safety at higher doses in a trial involving patients with hypertension~     complicated by diabetes.~   "
65662|NCT02707536|"~     The goal of this project is to evaluate the influence of platelet rich fibrin (PRF) in~     extraction socket healing with or without particulate bone graft. The hypothesis of this~     study is that PRF will enhance the extraction socket healing and new bone formation when~     compared to extraction sockets grafted without PRF.~   "
65548|NCT02709018|"~     This study is being conducted to determine if losartan, an angiotensin receptor blocker~     (ARB), is safe and effective in the treatment of posttraumatic stress disorder (PTSD)~     symptoms. The study is also intended to determine if certain genetic markers are useful in~     predicting PTSD symptom reduction with losartan. Approximately 160 subjects with chronic PTSD~     ages 18-65 will participate in this study across five sites. Subjects will be assigned by~     chance to take either flexibly dosed losartan (up to a maximum dosage of 100 mg) or placebo~     (which resembles the study drug but has no active ingredients), once a day for 10 weeks.~     Furthermore, it is hypothesized that CC homozygotes for rs4311 SNP in the ACE gene will have~     a superior response to losartan on PTSD symptoms compared to T carriers.~   "
65549|NCT02709005|"~     This is a Phase II, Double-Blind, Randomized, Placebo-Controlled, Multi-center Trial~     enrolling 120 subjects with Bacterial Vaginosis who will be randomized at a ratio of 2:1 to~     receive active test article (5% Monolaurin Vaginal Gel) or placebo (vehicle). The primary~     objective is to assess the safety and tolerability of 5% Monolaurin Vaginal Gel compared to~     vehicle placebo gel (excipients only) and to assess the efficacy by clinical cure rate of 5%~     Monolaurin Vaginal Gel compared to vehicle placebo gel at Visit 2.~   "
65550|NCT02708992|"~     This is a PK study of a multi-dose oral cefixime regimen (three 800 mg doses given on a q~     8-hour schedule) alone and also co administered with a single 1000 mg oral dose of~     azithromycin, both within a 24-hour period, in order to achieve total serum cefixime levels~     of mcg/mL for at least 20 hours. This will determine the tolerability of the regimen and~     whether there are significant changes in cefixime PK after co-administration. The primary~     pharmacokinetic objectives are: to determine if a cefixime dosing regimen of three 800 mg~     doses given alone, on a q 8-hour schedule achieves a total serum cefixime level that exceeds~     2.0 mcg/mL for at least 20 hours; to determine if a cefixime dosing regimen of three 800 mg~     doses given on a q 8 hour schedule co-administered with a single 1000 mg of azithromycin,~     achieves a total serum cefixime level that exceeds 2.0 mcg/mL for at least 20 hours; and to~     evaluate whether a single 1000 mg dose of azithromycin alters the PK of a three dose regimen~     of 800~   "
65551|NCT02708979|"~     The high worldwide prevalence of overweight and obesity as well as metabolic and disease~     consequences, are well-documented. The positive energy balance underlying obesity is~     attributable to excess energy intake and/or insufficient energy expenditure. However, it~     seems that the increase in mean body weight can be sufficiently explained by increases in~     mean energy intake. It has been proposed that this overeating is partly caused by increased~     availability of highly processed energy dense, high reward foods. Psychosocial stress and~     sleep insufficiency is pervasive in industrialized societies. A growing body of evidence~     suggests stress to be involved in obesity, although it is unknown whether stress is a cause~     or consequence. Stress affecting dietary intake; skewing intake towards greater consumption~     of highly palatable energy dense foods, also referred to as high reward foods. A causal~     relationship between stress and reward seeking behavior is supported by findings from animal~     studies reporting rewarding behavior by consumption of sweet tasting food in response to a~     stressor.~      Our aim is to investigate differences in purchases of particular food-items in free living~     individuals, during a stressful (upcoming exam) and non-stressful (no upcoming exam) period.~      Hypothesis: Participants will purchase more high reward foods during the pre-exam period,~     compared to the control non-exam period.~   "
65552|NCT02708966|"~     Prediabetes (PD) was defined as an state in which glucose levels are above normal but not~     enough to meet criteria for the diagnosis of type 2 diabetes (T2D). PD can be presented as~     impaired fasting glucose (IFG), impaired glucose tolerance (IGT) and glycated hemoglobin A1c~     (A1C) altered. The International Diabetes Federation (IDF) reported that in 2013 the~     prevalence of IGT was 6.9% which is equivalent to approximately 316 million individuals with~     IGT, it is expected that by 2035 this number will increase to 417 million people affected.~     Many hypoglycemic effects attributed to Gymnema sylvestre have been reported, including:~     increase of insulin secretion, regeneration of pancreatic islet cells, increased glucose~     utilization in various ways and inhibition of glucose uptake in the intestine.~   "
65553|NCT02708953|"~     Headaches have been listed as 1 of the 10 most disabling conditions worldwide. (Stovner et~     al., 2007) and cervicogenic headaches (CeHs) comprise 15% of the individuals with these~     complaints. (Nillsson, 1995); (Fernandez de-las-penas et al., 2005) The current best approach~     to the conservative care of this condition has yet to be determined. The primary aim of this~     study is to determine whether individuals with CeHs will respond to a program of thoracic~     spine thrust manipulation in isolation. This may further the current body of evidence by~     offering an alternative, potentially safer approach to the conservative care of individuals~     with this condition. Additionally, results of this study may serve to drive a larger scale~     Randomized Clinical Trial (RCT) by offering information regarding feasibility of recruitment~     of individuals with chronic CeHs as well as timing and dosing of the intervention.~   "
65554|NCT02708940|"~     This research project aims to evaluate the feasibility and effectiveness of a new approach to~     tailored mobile applications using the Chorus Participatory Mobile Framework. PHP and IOP~     program participants—patients and therapists--will be consented and enrolled by study staff.~     Study participants will be invited to workgroups specific to their program to discuss the~     usability of Chorus and be asked to complete surveys on demographics, satisfaction,~     self-efficacy, and involvement with Chorus and usability of the tool.~   "
65568|NCT02708758|"~     There is a lack of international uniformity in the approach to the screening and diagnosis of~     gestational diabetes mellitus (GDM). The new diagnostic criteria by the International~     Association of Diabetes and Pregnancy Study Groups (IADPSG) based on data from the study of~     Hyperglycemia and Adverse Pregnancy Outcomes (HAPO) have created controversy because of the~     lack of clinical evidence of treatment benefit for mild GDM and the treatment effects on~     perinatal outcomes. The purpose of the present study is to know the efficacy of treatment to~     reduce adverse pregnancy outcomes in Mexican women diagnosed with GDM by IADPSG criteria.~   "
65569|NCT02708745|"~     The overall goal of this project is to determine whether integrating a novel parent-report~     measure of vaccine hesitancy into pediatric primary care is effective in improving acceptance~     of childhood vaccines among vaccine-hesitant parents.~   "
65663|NCT02707523|"~     The proposed study will be a randomized, double masked, placebo-controlled pilot trial of~     azithromycin treatment in children with RSV-induced respiratory failure.~   "
65555|NCT02708927|"~     In addition to the physical, cognitive and psychological symptoms experienced by individuals~     with Multiple Sclerosis (MS), there is new research which indicates that some individuals~     with MS have a deficit in emotional processing, specifically, facial affect recognition.~     Emotional processing is defined as a central aspect of social cognition. Models of social~     cognition indicate that emotional processing is an essential component of interpersonal~     relationships. The failure to accurately perceive other's emotions has been shown to lead to~     difficulty in social relationships, misinterpreting other's affect, and consequently,~     inappropriate responding.~      However, even though a significant number of individuals with MS have impairments in~     emotional processing, we do not yet have an understanding of how these impairments affect the~     social functioning of individuals with MS, including the impact of these deficits on family~     structure. It is well-known that MS impacts one's social functioning including factors such~     as employment, daily living activities and interpersonal relationships. Recently a strong~     correlation was observed between reduced social participation in MS and quality of life.~     There is evidence to suggest that emotional processing deficits lie at the heart of this~     reduced social participation in persons with MS, leading to decreased social functioning and~     thus reduced quality of life. However, to date, this hypothesis has not been tested.~   "
65556|NCT02708914|"~     The primary objective of this study is to evaluate a 1:1 dose conversion from Eprex® to~     UB-851 in terms of clinical efficacy and safety in subjects with chronic renal failure~     receiving hemodialysis.~   "
65557|NCT02708901|"~     The purpose of this study is to assess the effects of a 6-months supplementation with~     probiotic Vivomixx® on inflammatory and gastrointestinal (GI) biomarkers, gastrointestinal~     disturbances, behavioral and developmental profiles, and neurophysiological features in~     preschoolers with Autism Spectrum Disorders (ASD) with or without GI symptoms.~   "
65558|NCT02708888|"~     The aim of this study is to further explore the effects of additional customized trunk~     exercises on clinical and biomechanical gait performance. Despite of the evidence~     demonstrating the importance of trunk control after stroke, studies about the effects of~     trunk rehabilitation on gait performance are inconsistent. The findings of this study might~     lead to new scientific insights in the importance of the trunk during gait rehabilitation in~     people suffering from stroke submitted to a rehabilitation hospital.~   "
65559|NCT02708875|"~     Insulin resistance (or pre-diabetes) is diagnosed using the oral glucose tolerance test.~     However, high blood glucose levels during this test may adversely impact on microvascular~     function. Investigators will determine whether a liquid mixed meal challenge (from~     carbohydrate, protein and fat) is a more appropriate test for assessing microvascular-derived~     insulin resistance.~   "
65560|NCT02708862|"~     Four methods of preoxygenation will be compared in healthy volunteers~   "
65561|NCT02708849|"~     The purpose of the study is to characterize the effects of a single, sub-anesthetic dose of~     ketamine in rs-fMRI in healthy subjects. Post-ketamine rs-fMRI data will demonstrate a~     pattern of increased global brain connectivity (GBC) in fronto-temporal cortex.~   "
65562|NCT02708836|"~     Emergence from general anesthesia with a laryngeal mask airway compared with an endotracheal~     tube has been shown to favorable with respect to limiting emergence phenomena such as~     coughing, straining, restlessness, and sympathetic stimulation leading to hypertension and~     tachycardia.~      Many anesthesiologists would prefer the use of an ETT to an LMA in cases in which higher~     ventilation pressures may be required, in those patients who are perceived to be high risk~     for reflux and pulmonary aspiration of gastric contents, as well as during cases that allow~     the anesthesiologist to have little accessibility the airway.~      The aim of this study is to investigate an airway management technique that would allow for~     the benefits of the ETT in terms of a secure airway for the duration of the surgical~     procedure as well the potential for less emergence phenomena seen when emerging with an LMA.~   "
65563|NCT02708823|"~     Postoperative delirium (POD) and postoperative cognitive dysfunction (POCD) are common~     complications after surgery and may affect elderly patients in particular. CogCheck, an~     application for tablet computers, was developed with the intention to assist preoperative~     risk screening for POD and POCD in surgical patients. The aim of this study is to generate~     normative data with cognitively healthy participants for the application.~   "
65564|NCT02708810|"~     To determine the feasibility of frameless Virtual Cone trigeminal neuralgia radiosurgery at a~     single institution prior to multi-institutional enrollment.~   "
65565|NCT02708797|"~     Migraine with aura (MA) is an independent risk factor for stroke and is associated with~     silent brain infracts and T2 white matter hyperintensities on MRI. Previous studies using~     Transcranial Doppler (TCD) have shown an impairment of cerebral autoregulation in MA~     patients. Studies with positron emission tomography have demonstrated an activation of brain~     stem areas during migraine attack. An increased density of brain stem grey matter as measured~     on MRI with voxel based morphometry (VBM) has been found in MA patients. As brain arteries~     and arterioles are innervated by ascending tracts from aminergic brainstem nuclei, th study~     hypothesize a negative correlation between the density of brainstem nuclei and the efficiency~     of cerebral autoregulation in MA patients compared with controls.~      Brainstem grey matter density will be studied with a MRI Philips 3 Tesla with a 32-channel~     antenna and voxel-based morphometry (VBM) cerebral autoregulation will be measured in the~     time domain using Transcranial Doppler (TCD) and the Mx method.~      MA patients will be studied in a headache-free period. MRI and Transcranial Doppler (TCD) are~     non-invasive technics and will be performed on the same day.~   "
65566|NCT02708784|"~     The aim of the project is to develop new Magnetic Resonance (MR) imaging techniques for~     better diagnosis and monitoring of patients with muscular disorders.~      Muscle quality in patients with Late Onset Pompe Disease (Acid Maltase Deficiency type 2) and~     in patients with Myotonica Dystrophy will be evaluated, by determining muscle strength in~     relation to muscle size and muscle strength in relations to fat-muscle ratio.~   "
65567|NCT02708771|"~     Assess whether high doses of ?-3 fatty acids added to standard treatment of patients with~     acute hearta failure, hypoalbuminemia and high inflammatory activity, promotes an increase in~     serum albumin~   "
65570|NCT02708732|"~     This study is a prospective, cross-sectional survey to be administered to real patients in~     remission from DLBCL using a 15-minute postal or online survey. The project is designed to~     describe the impact of DLBCL remission on health utility and quality of life. Data collection~     will occur over a 4-month period.~   "
65575|NCT02708667|"~     Crizotinib, an inhibitor of anaplastic lymphoma kinase (ALK), was approved by Food and Drug~     Administration (FDA) for the treatment of patients with ALK-positive non-small cell lung~     cancer (NSCLC) and its administration has achieved considerable success. However, adverse~     effects inevitably occurred and the most common one was hepatic toxicity, appearing as~     elevating alanine aminotransferase(ALT) and aspartate aminotransferase(AST). Therefore, the~     investigators try to figure out the mechanism of crizotinib-inducing hepatic toxicity, and~     explore whether there is any biological marker to diagnose this side effect in an early~     stage, which may realize individualized therapy with more efficacy and less side effects.~   "
65576|NCT02708654|"~     Using a 2-arm, randomized controlled trial (RCT) among CHF patients at the University of~     Pennsylvania Health System (UPHS), to test the effectiveness of applying automated hovering~     to improve outcomes among CHF patients at high risk of readmission.~   "
65577|NCT02708641|"~     This is a phase II study to evaluate the effect of pembrolizumab on the duration of remission~     in acute myeloid leukemia. Pembrolizumab is given after complete remission is obtained in~     those with AML at least 60 years old who are not candidates for allogeneic stem cell~     transplant. The primary purpose of this study is determine if the time to relapse can be~     extended. Additionally, the safety and tolerability of pembrolizumab will be closely~     monitored.~   "
65578|NCT02708628|"~     To investigate the efficacy of prophylactic use of a topical gel containing extract of allium~     cepae, allantoin and heparin after surgical removal of the primary cesarean scar in the~     second cesarean section.~   "
65579|NCT02708615|"~     This study compares two different types of speculum insertion to determine the level of~     discomfort they might cause. This study compares the straight horizontal insertion (SHI) of~     the speculum and the vertical insertion and rotation (VIR).~      Participants are randomly assigned to one of the two insertion groups and are not told which~     group they are in until the examination is over. Participants rate their level of discomfort~     immediately after insertion of the speculum.~      Basic demographic information (e.g., age, ethnicity, number of vaginal deliveries, menopausal~     status, etc.) and clinical information are also collected to determine if other factors~     influence the level of discomfort experienced.~      *NOTE* This is NOT a paid study.~   "
65580|NCT02708602|"~     Labor and delivery is a unique physiological experience of women. Inappropriate length of~     labor progress during vaginal delivery may produce great risks for mother and fetus.~     Especially the slow progress is one of the most important reasons for the occurrence of~     cesarean section during vaginal delivery, which still with a high incidence in recent~     years.Previous studies have found that there was a significant correlation between the~     genetic polymorphisms of β 2-adrenergic receptor (β2AR) and the duration of vaginal~     delivery.Therefore, the researchers intend to investigate the distribution of β2-adrenergic~     receptor (β2AR) genetic polymorphisms among Chinese parturient and observe the relationship~     between the genetic polymorphisms and labor process after labor analgesia.~   "
65581|NCT02708589|"~     In this study, patients undergoing the bariatric surgery will be assigned to take either~     probiotic capsules or placebos from 1 month before surgery to 3 months after the surgery.~     Their anthropometric and biochemical measurements will be assessed every 3-6 months, and will~     be compared in two groups.~   "
65582|NCT02708576|"~     The purpose of this study is to determine the safety and tolerability of NGM313, both single~     dose and multiple doses, in normal healthy overweight and obese adult participants.~   "
65583|NCT02708563|"~     Feasibility study to randomize non-vigorous newborn infants born through meconium-stained~     amniotic fluid to endotracheal suctioning or immediate resuscitation.~   "
65584|NCT02708550|"~     Epidemiological studies have shown that patient transfer is a risk factor for back pain, back~     injuries and long term sickness absence, whereas consistent use of assistive devices during~     patient transfer is associated with reduced risk of back injury. In consequence, Danish~     hospitals have made great efforts to increase knowledge, availability and use of assistive~     devices to reduce work-related physical strain due to patient transfer. Yet, a recent survey~     among more than 300 nurses and nurses' aides showed that two thirds rarely uses assistive~     devices during patient transfer. Thus it seems relevant to investigate barriers,~     opportunities and practical solutions for increasing use of assistive devices among~     healthcare workers. The purpose of this study is to evaluate a participatory organizational~     intervention for improved use of assistive devices during patient transfer.~   "
65585|NCT02708537|"~     The hypothesis is growing semen samples with plasma rich in growth factors (PRGF), because it~     could improve sperm motility in patients subsidiary TRA, ultimately improving pregnancy~     rates.~   "
65586|NCT02708524|"~     This is a multi-site, 5-visit, double-masked, dispensing study comparing an investigational~     contact lens with currently-marketed contact lenses. The objective of the study is to~     evaluate the comfort of the lenses when worn for 30 (-2/+6) days on daily wear modality.~   "
65587|NCT02708511|"~     This pilot clinical trial studies copper Cu 64-DOTA-B-Fab positron emission tomography~     (PET)/computed tomography (CT) in imaging patients with ovarian and breast cancer. Cancer~     antigen (CA)6 is an antigen (substance) found on the surface of several types of cancer cells~     such as cancer of the ovary and breast. Diagnostic procedures, such as copper Cu~     64-DOTA-B-Fab PET/CT, may help identify CA6 positive tumors and allow doctors to plan better~     treatment.~   "
65621|NCT02708069|"~     The goal of this project is to develop and test e-Unstuck, an e-learning intervention that~     (1) provides advanced training to parents of children with Autism Spectrum Disorder without~     Intellectual Disability (ASDwoID) on how to implement the evidence-based Unstuck and On~     Target (UOT) curriculum at home and (2) is built on 3C's proprietary, state-of-the-art,~     Dynamic e-Learning Platform, an established platform with high ratings of quality, value,~     usability, and feasibility from end users. As a result of the pilot efficacy test, the~     investigators hypothesize that (1) parents who interact with the e-Unstuck software will~     report greater knowledge and use of UOT principles, less parenting stress and greater~     parenting sense of competence, and improved child executive function (EF) and social skills~     compared to control parents, (2) parents who spend more time engaged with the intervention~     will show greater improvements in outcome variables, and (3) parents who interact with the~     e-Unstuck software will find the software to be of high quality, value, usability, and~     feasibility.~   "
65588|NCT02708498|"~     The research on ageing during the last couple of decades has increasingly focused on~     questions regarding the quality of life and life satisfaction of the old people. Yet the~     research indicates that when it comes to the final stage of life, the end includes~     unnecessary suffering and the quality of life drops. Palliative care has traditionally been~     provided successfully to younger persons dying from incurable illnesses while older people~     dying of multiple morbidities or old age has received far less of this type of care.~     However, sixty percent of all people who died in Sweden in 2010 were at least 80 years old~     and it is well known that dying among older people often is a prolonged period of suffering.~     One reason might be that it is more difficult to identify when the final stages of life~     begins for older persons.~      The purpose of this project is to implement and evaluate how a knowledge-based model for~     palliative care in nursing homes affects the quality of life and the participation in the~     care process for older persons in nursing homes and their next of kin. A second aim is to~     explore the staff's implementation process of palliative care and the role of the leadership.~     The final aim is to investigate which factors (barriers and facilitators) that affect the~     implementation process of this model.~   "
65589|NCT02708485|"~     The aim of this study is to evaluate the effect of a 3-month walking program on brain energy~     metabolism in patient with mild Alzheimer's disease (AD). Two groups of sedentary patients~     with mild AD are followed and compared over a 3-month period of time: Control (non-active)~     and walking (from 15 to 45 minutes of exercise on a treadmill, 3 times a week for 12 weeks)~     groups. All the participants are evaluated on their cognition, brain volumes (MRI) and brain~     fuel consumption (PET scan with 18-FDG and 11C-AcAc) at the beginning and at the end of the~     study.~   "
65590|NCT02708472|"~     This clinical trial is an investigator-initiated open label study designed to evaluate the~     safety and efficacy of sTMS in subjects with Generalized Anxiety Disorder.~   "
65591|NCT02708459|"~     Comparing different drugs used in Transversus abdominus plane analgesia after donor~     hepatectomy. Patients will be divided into three groups; control group, Bupivecaine group,~     and Dexmedetomedine group according to the used drug~   "
65592|NCT02708446|"~     The primary goal of this study is to directly compare repeat doses of sublingual and buccal~     routes of 400 mcg misoprostol following mifepristone for second trimester abortion in order~     to determine if sublingual route confers an advantage with respect to efficacy and median~     time to complete abortion.~   "
65593|NCT02708433|"~     Anecdotal data suggest that the buffered form of the local anesthetic is more potent at equal~     dosages, and a lower dosage of the drug might be used with an effect equal to higher dosage~     not buffered. Clinical data are needed to confirm these anecdotal data. No data exist~     comparing buffered local anesthetics at lower drug concentrations to current dosages commonly~     used in dental and oral surgical procedures~   "
65594|NCT02708420|"~     Laryngoscopy and endotracheal intubation causes significant hemodynamic response and thus~     presents an increased risk for patients undergoing cardiac bypass surgery. Prevention or~     reduction of this increment is important for hemodynamic control. In this randomized single~     blind study, the aim of this study is to compare the hemodynamic responses of two different~     laryngoscopy techniques with Glidescope and Macintosh laryngoscope in coronary cardiac bypass~     surgery patients.~   "
65595|NCT02708407|"~     This trial is to establish whether ultrafiltration by peritoneal dialysis is a clinically~     effective treatment for patients with severe heart failure and moderate chronic kidney~     disease, thus improving quality of life and symptoms.~   "
65596|NCT02708394|"~     This study will investigate the molecular mechanisms of atypical-antipsychotic induced~     insulin resistance. This will be accomplished by administering olanzapine or placebo to~     healthy subjects for 7 days and analyzing genetic and protein changes in peripheral tissues~     known to play an important role in insulin resistance pathophysiology.~   "
65597|NCT02708381|"~     The main purpose of this study is to pilot a real time electronic consultation with an~     Oncogeriatric Information Team (OGIT) located at Moffitt using Total Cancer Care (TCC).~     Investigators want to see for which type of patients this information is the most useful, and~     work out the practical ways of making this process work.~   "
65598|NCT02708368|"~     CKD-MBD (Chronic Kidney Disease - Mineral and Bone Disorder) is an extensive disease and~     includes dysfunction of the mineral metabolism, the bone metabolism and cardiovascular~     diseases in the context of renal insufficiency. Clinical pictures of peripheral artery~     occlusive disease (PAOD), Coronary artery disease (CAD) and arterial hypertension favours~     among other main risk factors (smoking, obesity, etc.) additional cardiovascular~     complications. For this reason it makes sense to monitor these patients regularly. For this~     purpose the determination of different biomarkers would be appropriate for control of the~     course of disease.~      During various studies the biomarkers FGF23, s-klotho, sclerostin, DKK1, BMP2, YKL-40 und MGP~     were established as indicators for the disease activity, as diagnostic criteria for the~     existence of CKD-MBD or as risk markers for the incidence of adverse events (incl. death)~     within the scope of CKD-MBD. For the clinical routine care application of these parameters~     standard operating procedures (SOP) are missing for the determination method relating to~     optimal pre-analytic and analytic procedures. These analyses are necessary to ensure the~     reproducibility of study results and to transfer these parameters in the clinical daily~     routine for risk stratification.~   "
65599|NCT02708355|"~     The purpose of this pilot study is to investigate the association between gastric acid~     suppression and relief of 24 hour heartburn following treatment with the proton pump~     inhibitor (PPI) drug esomeprazole in frequent heartburn patients.~   "
65600|NCT02708342|"~     RESEARCH METHODS Study Design Observational, Retrospective, Single-center, Single-arm Study~     of patients treated with raltegravir plus abacavir and lamivudine.~   "
65601|NCT02708329|"~     The aim is to compare the results of using T-provisional and Mini-Crush stenting techniques~     in patients with bifurcation lesions in the CTO segment.~   "
65602|NCT02708316|"~     Research already found that patients with autistic spectrum disorders lack of Prevotella~     intestinal type, then schizophrenia patients may also show the specific intestinal type, so~     investigators want to detect the gut metagenome of schizophrenia patients by high-throughput~     DNA sequencing to find specific intestinal type, so as to achieve the purpose of~     schizophrenia diagnosis. According to the detection of inflammatory factors in the blood,~     nerve growth factor in the cerebrospinal fluid, to find the mechanism of the~     gut-microbes-brain axis.~   "
65604|NCT02708290|"~     Visual puzzles have been used for centuries to facilitate early development in kids. Mental~     Imagery Therapy for Autism (MITA) is a unique, early-intervention application for children~     with Autism Spectrum Disorder (ASD). The app includes bright, interactive puzzles designed to~     help children learn how to mentally integrate multiple features of an object, an ability that~     has proven to lead to vast improvements in general learning. Success with MITA puzzles could~     overtime result in significant improvements in a child's overall development, specifically in~     the realms of language, attention and visual skills.~      SCIENCE BEHIND THE PROJECT:~      MITA is based on Pivotal Response Treatment (PRT), one of the best-supported therapies for~     children diagnosed with ASD. MITA aims to develop one of four pivotal skills targeted by PRT:~     a child's ability to notice and to respond to multiple visual cues presented simultaneously.~     This ability is typically impaired in individuals with autism, leading to what is commonly~     described as stimulus overselectivity, or tunnel vision. Improving the capacity to discern~     and respond to multiple cues has been shown to reduce stimulus overselectivity, which in turn~     leads to vast improvements in general learning.~      The visual exercises follow a systematic approach for developing a child's ability to notice~     multiple characteristics, or features of an object. MITA starts with simple exercises that~     teach a child to attend to only one feature, such as size (see screenshot 1) or color~     (screenshot 2). Over time, the exercises get more difficult and require the child to attend~     to two features simultaneously, such as both color and size (screenshot 3). In order to solve~     these puzzles, a child must learn how to hold two pieces of information in their mind (both~     the size and the color of an object) and make a decision based on the combination of these~     features. Once a child has practiced attending to two features, the program moves on to~     puzzles that require attending to three features, such as color, size and shape (screenshot~     4), and then eventually to puzzles that involve attending to an ever-increasing number of~     characteristics.~      As a child progresses through MITA's systematic exercises, he or she is developing the~     ability to simultaneously attend to a greater number of features, reducing the propensity~     towards tunnel vision, and thus developing an essential component of language. The ability to~     mentally build an image based on a combination of multiple features is absolutely necessary~     for understanding syntax, spatial prepositions and verb tenses.~      MITA is designed for early childhood and intended for long-term, daily use. It is designed to~     be engaging and educational, as well as adaptive and responsive to the individual abilities~     of each child.~   "
65605|NCT02708277|"~     The purpose of this study is to compare the outcome of loop intrauterine contraceptive device~     and heart-shaped intrauterine balloon for the adjunctive treatment of severe intrauterine~     adhesions in patients with infertility.~   "
65606|NCT02708264|"~     Spontaneous preterm birth (SPTB) remains the number one cause of perinatal mortality in many~     countries, including the United States. Multiple gestations are at increased risk of SPTB. A~     short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good~     predictor of SPTB, in both singletons and twins.~      The cervical pessary is a silicone device that has been used to prevent SPTB. The efficacy of~     the cervical pessary has been assessed in several populations including singletons with short~     CL, unselected twins, twins with short CL, and triplet pregnancies. Several randomized~     clinical trials (RCTs) have been published, and several are ongoing. However, no consensus on~     use of the cervical pessary in pregnancy or guidelines for management have been assessed.~   "
65607|NCT02708251|"~     The intrauterine device (IUD) is a long-acting, highly effective, reversible contraceptive~     method that may be underutilized due to fear of pain during insertion. Although providers~     frequently prescribe non-steroidal anti-inflammatory drugs (NSAIDs) for IUD insertion, there~     is no evidence for any pain reduction. Women can experience high levels of pain when the IUD~     is placed inside the uterus, and fear of this pain could be a reason that women decide not to~     use this method.~   "
65608|NCT02708238|"~     A multicenter prospective, randomized comparative study will be conducted in infants with~     colic, according to Rome III criteria. Enrolled infants will be assigned at random to receive~     Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122), L reuteri DSM~     17938 (108 CFU) or simethicone. Treatment will be given to subjects for 28 days and they will~     be followed for 4 weeks. Treatment success will be assessed at the end of study period. Daily~     crying and fussing times will be recorded in a structured diary, and maternal questionnaires~     will be completed to monitor changes in infant colic symptoms and adverse events.~   "
65609|NCT02708225|"~     Medical clowns are known to assist in relaxing children and allowing better cooperation~     during performance of medical procedures.~      The ability of medical clowns to improve the motivation of children to perform active tasks~     was never examined to date.~      The investigators would like to examine the influence of the clowns' presence on the~     performance of pulmonary function test.~   "
65610|NCT02708212|"~     The Same-day bidirectional endoscopy (BDE) is commonly used in clinical practice. However,~     the optimal sequence of performing a same-day BDE has not been well-established.The primary~     aims of this study are to compare the sedative doses and patient discomfort between the study~     groups who received a colonoscopy followed by and EGD (colonoscopy-EGD), or an EGD followed~     by a colonoscopy (EGD-colonoscopy) during a same-day BDE. The secondary aim is to assess~     colonoscopy performance, including the cecal intubation time and adenoma detection rate~     between the two endoscopic sequences.~   "
65611|NCT02708199|"~     Detection of the drug resistance molecular markers for falciparum and vivax in Longitudinal~     follow-up samples collected in Shwegyin Township, Bago Region that is Artemisinin Resistance~     Containment Tier I.~   "
65612|NCT02708186|"~     This study seeks to evaluate the safety and efficacy of Nelotanserin for the treatment of~     Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD) in subjects with dementia with Lewy~     bodies (DLB) or Parkinson's disease dementia (PDD).~   "
65613|NCT02708173|"~     This study evaluates the safety of Quadrivalent Influenza Virus Vaccine in Healthy People~     Aged years 3 to 60.40 Subjects will be equally divided into 2 groups,including 3-17 years old~     and 18-60 years old.Adult group first receive one dose of Quadrivalent Influenza Virus~     Vaccine.Then minors group also receive one dose of Quadrivalent Influenza Virus Vaccine after~     7 days.~   "
65614|NCT02708160|"~     This is a double blind, cross-over, controlled clinical trial utilizing thirty (30) adults to~     evaluate remineralization of early caries lesions.~   "
65615|NCT02708147|"~     This study aims to evaluate the recovery of children with bronchiolitis with and without~     physical therapy treatments.~      The experimental group will receive educational information and 5 sessions of physiotherapy~     with the same protocol, at home or in physical therapy office. The control group will only be~     evaluated.~      For both the experimental and control groups the lung sounds are recorded and the Wang's~     respiratory severity scale calculated initially and on the 3th, 5th and 21st days and~     computorized. After 3 months of the initial contact, there will be an interview by the phone~     about relapses or other clinical signs of bronchiolitis until then.~      It is expected that the children receiving physiotherapy have a better recovery than the~     control group.~   "
65616|NCT02708134|"~     This is a prospective, observational, multi-center cohort study of pediatric cardiac arrests.~      The purpose of the study is to determine the association between chest compression mechanics~     (rate, depth, flow fraction, compression release) and patient outcomes. In addition, the~     investigators will determine the association of post cardiac arrest care with patient~     outcomes.~   "
65624|NCT02708030|"~     This randomised trial is undertaken to assess whether MAD or LGIT is non-inferior to KD with~     regard to seizure control at twenty-four weeks among children with drug resistant epilepsy.~     The hypothesis of the study is that in 1 to 15-year-old children with drug resistant~     epilepsy, use of Modified Atkins Diet (MAD) or Low Glycemic Index Therapy (LGIT) as an add on~     to the ongoing anti-epileptic drugs would not be inferior to ketogenic diet by >15% in terms~     of seizure reduction from baseline seizure frequency at 24 weeks.~      The primary outcome of the study is to determine the efficacy of MAD as compared to KD and~     LGIT as compared to KD for seizure reduction in drug resistant epilepsy following 24 weeks of~     dietary therapy in 1 to 15-year-old children on anti-epileptic drugs. The change in seizure~     frequency will be estimated as percentage change in seizure reduction at 24 weeks as compared~     to baseline.~   "
65625|NCT02708017|"~     The purpose of this study was to compare the analgesic efficacy of the ultrasound guided~     bilateral subcostal tap block with ultrasound guided bilateral posterior tap block for~     postoperative analgesia after laparoscopic cholecystectomy~   "
65626|NCT02708004|"~     This clinical study will be conducted to evaluate the effect of ACT-132577 on fluid~     homeostasis in healthy subjects.~   "
65627|NCT02707991|"~     Effective all-oral medications are finally available to cure hepatitis C virus, which affects~     more than 4 million Americans and one-in-four people living with HIV. However, many barriers~     exist that prevent people with HIV/HCV co-infection from getting this curative treatment,~     including low knowledge, competing demands, and drug interactions with HIV medications.~      This study evaluates if a hepatitis C nurse case management intervention in an HIV primary~     care clinic will improve patient attendance to hepatitis C care and help people start~     hepatitis C treatment earlier. Half of the participants will receive brief case management~     with a nurse, while the other half will receive usual clinic care.~   "
65628|NCT02707978|"~     The purpose of this research study is to evaluate tau distribution in the brain of subjects~     with: FTD caused by different genetic mutations, any mutation carriers (with or without~     symptoms), any non-mutation carrier, any sporadic FTD, normal controls.~   "
65629|NCT02707965|"~     Some epilepsy patients are described as GB when they have worsened seizures or side effects~     related to switching between brand name and generic, or between generic antiepileptic drug~     (AED) products. In concert with Aim 1 (protocol BEEP2a), this study will uncover possible~     reasons for patient problems with the drug switching. Factors that will be studied in GB~     epilepsy patients include physiologic, psychological, and genetic factors, including in this~     protocol whether brand and generic AEDs are pharmacokinetically similar in GB individuals.~   "
65630|NCT02707952|"~     The purpose of this study is to evaluate the efficacy and safety of ABT-493/ABT-530 in~     Japanese adults with chronic hepatitis C virus infection.~   "
65631|NCT02707939|"~     Autism Spectrum Disorder (ASD) is the fastest growing neurodevelopmental disorder in the~     world. Approximately 1% of the population worldwide is affected by this disorder. Children~     with ASD exhibit some very stereo-typical behaviors. Their daily functionality depends on~     very rigid and predictable schedules and routines. Any changes in their schedules can often~     trigger negative emotional outbursts. The need to come to the hospital for procedures can be~     one such trigger. The purpose of this study is to examine the post anesthesia behavior~     outcomes of children with ASD.~   "
65632|NCT02707926|"~     Hypothesis:~      Antiretroviral drugs (ARVs) with enhanced LT penetration characteristics in vitro and in~     macaques will translate into an ARV regimen with increased LN and GALT concentrations and a~     faster decay and more potent suppression of HIV replication in LT in HIV-infected persons.~      Objectives:~        1. Determine lymph nodes (LN) and gut-associated lymphoid tissue (GALT) pharmacokinetics~          (PK) in HIV-infected persons on an antiretroviral drug (ARV) regimen.~        2. Determine virological responses of antiretroviral therapy in plasma, peripheral blood~          mononuclear cells (PBMCs) and lymphoid tissue (LT).~   "
65633|NCT02707913|"~     The purpose of the study is to compare the bioavailability of a generic product of amlodipine~     with that of a reference product when administered to healthy volunteers under fasting~     conditions. The test product name is BF-Amlodipine Tablet 10mg manufactured by Bright Future~     Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited, and the~     reference product is Norvasc Tablet 10mg. The plasma pharmacokinetic data of amlodipine~     obtained from two formulations will be used to access the interchangeability of the products~   "
65634|NCT02707900|"~     The purpose of this research study is to 1) evaluate the safety of a series of injections~     with the AGS-004 product in combination with a series of Vorinostat doses and 2) to help~     scientists evaluate ways of reactivating latent (non-acting) HIV virus and determine if the~     immune system can be made stronger to eliminate the activated HIV virus.~   "
65635|NCT02707887|"~     The purpose of this study is to:~        1. determine if a smartphone enhanced treatment for LETS ACT (LETS ACT-SE) is associated~          with increased long term treatment engagement, and in turn, improved long term treatment~          outcomes, and~        2. use functional magnetic resonance imaging (fMRI) to identify the effects of LETS ACT-SE~          on the neuromarkers of reward sensitivity.~   "
65636|NCT02707874|"~     This is a clinical study to investigate and compare a new programmed intermittent bolus (PIB)~     delivery method for continuous popliteal sciatic nerve block for pain relief in patients~     undergoing major ankle surgery compared with the current practice of continuous local~     anesthetic infusion (CI).~   "
65637|NCT02707861|"~     Ibalizumab is a monoclonal antibody that works by blocking HIV entry into the immune system~     cells (CD4+ or T-cells) the virus typically infects. Ibalizumab is intended for use in~     combination with other anti-HIV drugs in people with multi-drug resistant HIV and limited~     treatment options. This study will collect further information on the safety and tolerability~     of intravenously administered (IV) ibalizumab combined with an optimized background regimen~     for treating multi-drug resistant HIV-1 infection, and will provide continuing access to~     ibalizumab for patients completing a prior ibalizumab clinical trial.~   "
65718|NCT02706808|"~     The objective of this study is to assess whether supplementation with resistant starch from~     the rice-flour coffee developed by EMBRAPA, as well as from an already industrialized product~     (Hi-Maize of Ingredion®) could modulate the intestinal microbiota of patients with CKD ( both~     patients under conservative treatment, such as dialysis treatment), as well as exerting a~     beneficial effect with respect to reducing levels of inflammatory markers of oxidative~     stress, uremic toxins and in addition, markers of cardiovascular disease.~   "
65638|NCT02707848|"~     This 3-year school-based epidemiological study on child and adolescent mental disorders aims~     to obtain the prevalence rate and identify the psychosocial, individual, environmental, and~     familial risk factors for mental disorders including learning disability, autism spectrum~     disorder, attention-deficit hyperactivity disorder, oppositional defiant disorder, conduct~     disorder, mood disorders (major depression, dysthymia, bipolar disorder), anxiety disorders,~     phobia, obsessive compulsive disorder, sleep disorders, eating disorders, and substance use~     disorders in Taiwan.~   "
65639|NCT02707835|"~     The ultrasound imaging could be used to examine the thickness of dermis and the space between~     dermis and subcutaneous tissue. Whether the measurement of ultrasound imaging correlate to~     other measurement of edema is unknown.~      The purpose of this study is to investigate~        1. The reliability of measurement of edema using ultrasound imaging, and the correlation of~          measurement of ultrasound with other measurement tools.~        2. The different effect of edema control by manual lymph drainage technique and epidermis~          taping technique, and the cost-effective assessment.~      Our hypothesis :~        1. The measurement of edema with ultrasound imaging is a reliable method and correlate with~          other edema measurement with moderate correlation.~        2. Ultrasound measurement could demonstrate different effect of manual lymph drainage and~          epidermis taping, and different cost-effectiveness analysis.~   "
65640|NCT02707822|"~     The purpose of the study is to identify factors that may influence tacrolimus (TAC)~     pharmacokinetics, and the impact of gene polymorphism (ABCB1, CYP3A4, CYP3A5, POR) on~     pharmacokinetics of TAC in Taiwanese.~   "
65641|NCT02707809|"~     The microcirculation is altered in acute kidney injury and chronic kidney disease. The~     microcirculation is poor in end-stage renal disease patients receiving hemodialysis. Kidney~     transplant can improve the life quality of these patients. However, surgical stress and~     inflammatory response may cause microcirculatory dysfunction and intestinal injury. Moreover,~     the transplanted kidney would suffer from the ischemia and reperfusion injury, and it may~     result in acute kidney injury. In ischemia and reperfusion injury animal model,~     dexmedetomidine has been proven to attenuate kidney and intestinal injury. In our previous~     study of surgical stress and pain stimulation rat model, we found that dexmedetomidine~     attenuate the intestinal microcirculatory dysfunction. In patients receiving coronary artery~     bypass graft surgery, dexmedetomidine increases urine output and decreases postoperative~     serum level of neutrophil gelatinase-associated lipocalin.~      This study aims to investigate whether perioperative dexmedetomidine infusion may attenuate~     microcirculatory dysfunction, kidney injury, and intestinal injury for patients undergoing~     kidney transplant.~   "
65642|NCT02707796|"~     Oxygen reserve index (ORI) measured by multiple wave pulse co-oximeter is a new technological~     development in medical science. Our aim in this study is to identify the correlation between~     arterial oxygen pressure (PaO2) and ORI, and to identify the specificity and sensitivity of~     ORI as a tool to prevent hypoxia and hyperoxia in abdominal surgery patients.~   "
65643|NCT02707783|"~     The aim of the study is feasibility of complete coronary revascularization with bioresorbable~     vascular scaffold (BVS) implantation and assessment of treatment outcomes in a group of~     consecutive patients with stable and unstable angina in Russian population.~      The hypothesis of this registry study: 1) Complete coronary revascularization with BVS~     implantation will be feasible to perform in at least 70 percent of patient population with~     stable and unstable angina qualified for revascularization after coronary angiography, 2)~     Complete revascularization with BVS is as safe and effective as revascularization with~     standard BMS (Bare Metal Stent BMS/ Drug Eluting Stent DES stent implantation (published~     literature comparators in matched populations).~      Up to 2500 patients will be enrolled in 13 Russian high volume invasive cardiology centres.~     12 month clinical observation and 5-year clinical follow-up is expected.~   "
65644|NCT02707770|"~     Pulmonary rehabilitation (PR) is an exercise program tailored for patients with chronic lung~     disease that is a core part of the management of patients with Chronic Obstructive Pulmonary~     Disease (COPD). Many COPD patients develop low oxygen levels (desaturation) during exercise~     and this is often discovered when they are being evaluated for PR. Current practice is to~     administer oxygen to COPD patients with exercise-induced desaturation, but this is based on~     very limited evidence. This limited evidence relates to a short-term increase in exercise~     capacity and it is not known if this translates into longer term increases in activity or~     whether providing these patients with oxygen improves outcomes after PR.~      In addition it is not known if patients given ambulatory oxygen continue to use it after~     completing PR. Evidence for a beneficial effect of oxygen would provide a more solid evidence~     base for its use. Conversely demonstration of no effect would allow reassessment of the use~     of oxygen and whether the costs are justified. Therefore the aims of this study are to assess~     the effects of oxygen on outcomes from PR and assess the usage of ambulatory oxygen following~     completion of PR.~   "
65645|NCT02707757|"~     Anaemia in dialysis patients requires treatment with frequent dose adjustments. There are two~     current possible treatments for anaemia which are iron and erythropoietin stimulating agents~     (ESA). Dosages of these medications are currently guided by a patient's ferritin levels and~     haemoglobin, but these markers are known to be inaccurate. The current clinical protocol~     therefore tends towards overuse of both agents which can be associated with toxicity, and the~     reliance on these markers prevents retrospective assessment of treatment responsiveness. This~     study is designed to investigate the factors which predict which agent would produce a better~     response. Patients with a fall in haemoglobin will be given treatment with either iron or an~     increased dose of ESA as they are currently, but allocated at random rather than by poorly~     performing biochemical markers. The iron treated and ESA treated groups can then be analysed~     for factors which predict response in o~   "
65646|NCT02707744|"~     It is an observational study in patients with heart failure investigating the incidence of~     arrhythmias using a wearable device which can monitor heart rhythm for up to 14 days. In~     addition to gathering routine clinical information, research assessments include a symptoms~     questionnaire and a corridor walk test. Patients will be followed for clinical events~     (interventions for arrhythmias, hospitalisation, death) for 1 year.~   "
65647|NCT02707731|"~     This study aims to evaluate the acute effects of neonatal hydrokinesiotherapy in reducing~     stress in newborn preterm infants in the neonatal intensive care unit. Salivary cortisol~     samples were collected, pain applying the Neonatal Infant Pain Scale Scale (NIPS), heart~     rate, respiratory rate and oxygen saturation before and after hydrotherapy.~   "
65649|NCT02707705|"~     Preoperative anxiety before cesarean section is common and may be severe. Stress consequences~     are often deleterious for the mother and for the upcoming newborn. Means to reduce anxiety~     before cesarean section are limited. Anxiolytic drugs are avoided in the context of the birth~     of a newborn. Auricular acupuncture has been shown to relieve anxiety disorders. The aim of~     this study is to evaluate the anxiolytic effect of auricular acupuncture administered before~     an elective cesarean section. Anxiety will be measured at T0: inclusion (approximately 1-2~     hours before cesarean section) and T1: departure to surgical unit (approximately 30 minutes~     to 1 hour after T0). Patches (needle or needle-free) will be set up at T0 just after the~     initial anxiety assessment (anxiety Visual Analog Scale aVAS).~   "
65650|NCT02707692|"~     The purpose of this study is to determine the impact of Pneumococcus and Influenza vaccines~     on the HIV transcriptional activity in individuals who are virologically suppressed for at~     least 48 weeks on similar ART. The proposed study is a randomized double-blinded control~     trial conducted over 28 weeks. Randomized interventions will be injections of Influenza~     vaccine, Pneumococcal vaccine, and Placebo. Each participant will receive each injection but~     in a randomized order.~   "
65651|NCT02707679|"~     Patellofemoral Pain Syndrome (PFPS), also known as the anterior knee pain, is one of the most~     common musculoskeletal disorders. Most of the patients suffer from knee pain for long time.~     The aim of this study was to investigate the short-term effects of Mobilization with movement~     and Kinesiotaping on pain, function and balance in patient with PFPS.~   "
65652|NCT02707666|"~     This is a single institution, single-arm, window of opportunity pilot trial of pembrolizumab~     in patients with resectable malignant pleural mesothelioma. All patients will undergo a~     pretreatment PET/CT scan for clinical staging and a VATS procedure to acquire pretreatment~     tissue. Three cycles of pembrolizumab will then be administered (200 mg IV every 21 days). A~     PET/CT scan will then be repeated to assess response to pembrolizumab and then surgical~     resection will be performed via an extended/pleurectomy decortication at least 4 weeks after~     the third dose of pembrolizumab. Standard adjuvant chemotherapy consisting of cisplatin and~     pemetrexed for 4 cycles (every 21 days) will be given starting about 6-8 weeks following~     surgery, after a new baseline CT scan is obtained. Restaging CT scans will be obtained to~     assess response after every two cycles of chemotherapy. After the completion of standard~     chemotherapy, optional adjuvant treatment with pembrolizumab will be given to eligible~     patients for 1 year post-surgery.~   "
65653|NCT02707653|"~     This study will investigate the use of misoprostol for first-line treatment of incomplete~     abortion at tertiary hospitals in Myanmar.~   "
65654|NCT02707640|"~     This is a Phase 2, randomized, double-blind, placebo-controlled safety and tolerability study~     of N-acetylcysteine or placebo in participants with mild to moderate idiopathic pulmonary~     fibrosis (IPF) receiving background pirfenidone therapy.~   "
65655|NCT02707627|"~     A new era of outcomes for pediatric burn patients has begun as burn care continues to~     improve. Unfortunately, complete restoration of burn-injured skin may be limited by the~     development of hypertrophic scarring. Treatment with ablative fractional carbon dioxide laser~     therapy is one of the newest forms of scar therapy available. Although laser therapy has only~     been adopted by burn clinicians within the last several years, early evidence suggests that~     it may offer significant benefits. Thus, the proposed study will answer the following~     research question: In children aged 1 to 18 years with a hypertrophic burn scar, is the~     addition of ablative fractional carbon dioxide laser therapy to standard scar management more~     effective at improving the appearance and texture of the scar compared to standard scar~     management alone, as measured by the Vancouver Scar Scale from baseline to month 12?~     Ultimately, the completion of this study may lead to a fundamental change in the standard~     treatment of pediatric hypertrophic burn scars. In addition, the study findings will also be~     applicable to children and adults with scars resulting from other etiologies.~   "
65656|NCT02707614|"~     This study aims to describe the postoperative functions of patients after undergoing open or~     robotic prostastectomy. Primary endpoints will focus on complications in the post-anaesthesia~     care unit (PACU) which prevent dischard from PACU to the general ward. This include Aldrete~     scores and other complications that can be registrered descriptively. Furthermore, the study~     seeks to compare what influence open versus robotic prostastectomy have on peri- og~     postoperative complications.~   "
65657|NCT02707601|"~     This study will evaluate efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) as measured by the~     proportion of participants achieving hepatitis C virus (HCV) RNA below the lower limit of~     quantification (LLOQ) 12 weeks after the last dose of LDV/SOF (sustained virologic response~     (SVR) 12).~      This study will consist of 2 parts. In Part 1, the participants will be randomized to switch~     from stable antiretroviral (ARV) therapy to either E/C/F/TAF or F/R/TAF. The participants~     maintaining HIV-1 RNA < 50 copies/mL and tolerating E/C/F/TAF or F/R/TAF through Part 1 will~     continue to Part 2 where they will receive the LDV/SOF treatment.~   "
65658|NCT02707588|"~     The general aim of the study is to evaluate the anti-tumour activity and the tolerance~     profile of Pembrolizumab + RT in comparison to cetuximab + RT in patients with locally~     advanced HNSCC and to explore potential correlations between treatment outcome and the immune~     landscape.~   "
65659|NCT02707575|"~     The investigators will evaluate the concentrations of cytokeratin 8 in aqueous humor in eyes~     with exudative age-related macular degeneration (AMD) before therapy with intravitreal~     Ranibizumab, and identify associations with visual and anatomical outcome after treatment.~   "
65660|NCT02707562|"~     32 cystic fibrosis patients with the G551D mutation will be treated for 4 weeks, consisting~     of three consecutive treatment periods: two 1-week periods followed by one 2-week period,~     evaluating one dose of GLPG1837 each. After the treatment period, there is a 7-10 days~     follow-up period.~      During the course of the study, subjects will be examined for any side effects that may occur~     (safety and tolerability).~      Changes in sweat chloride will be assessed as biomarker from baseline onwards, and changes in~     pulmonary function (efficacy) will be explored throughout the study. The amount of GLPG1837~     present in the blood (pharmacokinetics) will also be determined.~   "
65661|NCT02707549|"~     Fluid management of children during neurosurgery is not well established. Hypotonic~     solutions, commonly still used in pediatric patients, may enhance cerebral edema and worse~     operative conditions. This study compares two different isotonic solutions administered~     perioperatively regarding acid base and fluid electrolyte disturbances.~   "
65664|NCT02707510|"~     The investigators group has piloted a 6-week psycho-educational program, Growing Resiliency~     And CouragE with Cancer™ (GRACE), that bring together a variety of strategies and experiences~     from an inter-professional perspective to mitigate distress among patients with an advanced~     cancer diagnosis. GRACE is a six-session, empirically anchored intervention emphasizing a~     Logotherapy (Existential Therapy) and Cognitive-Behavioral Therapy approach involving~     psycho-education and process-oriented experiences. The curriculum includes themes illustrated~     via PowerPoint slides with semi-structured delivery, video presentations, a variety of~     mindfulness meditation practices, and selected readings that serve to reflect and capture the~     theme for the week of the curriculum.~   "
65665|NCT02707497|"~     The purpose of this study is to determine whether recombinant human thrombopoietin(rhTPO) can~     rapidly increase the platelet counts, shorten the time of the platelet returned to normal,~     reduce platelet transfusion and bleeding events, decrease the length of ICU stay, and~     eventually reduce the 28-day mortality in septic shock patients with thrombocytopenia.~   "
65666|NCT02707484|"~     Gastrointestinal vascular malformation (GIVM), which is an important cause of acute or~     chronic gastrointestinal bleeding, currently lacks of effective treatment. The investigators'~     previous study first confirmed thalidomide treatment of GIVM bleeding was safe and effective.~     This prospective multi-center randomized controlled clinical trial intends to investigate the~     efficacy of thalidomide to the recurrent small intestinal hemorrhage due to GIVM.~   "
65667|NCT02707471|"~     Adjuvant endocrine therapy (AET) is a crucial component of treatment used to prevent~     recurrence and reduce breast cancer-related mortality for breast cancer patients with hormone~     receptor positive disease. Studies report low rates of adherence to AET (38% to 86%) and in~     our preliminary work, 65% of breast cancer patients taking AET reported one or more~     non-adherent medication taking behaviors (e.g., skipped dose, forgot, adjusted dose) in the~     past month. Symptoms (e.g., arthralgia, vasomotor symptoms) associated with AET are strongly~     related to non-adherence and early discontinuation of treatment. Poor adherence to AET due to~     symptoms may compromise the effectiveness of AET. Prior to conducting a clinical trial, we~     will conduct user testing of the self-management intervention protocol with 20 women. In the~     proposed randomized clinical trial, 400 women who are taking AET for breast cancer will be~     randomly assigned to one of two conditions: 1) a self-management intervention for improving~     adherence and symptom management, or 2) a general health education control condition. The~     self-management intervention integrates three key theory-based strategies for improving~     adherence to AET: coping skills training for managing symptoms (e.g., arthralgia, vasomotor~     symptoms), behavioral strategies for improving medication adherence, and symptom and~     medication education. The intervention addresses the specific symptoms a woman is~     experiencing and is designed to meet the needs of women who are at high risk for~     non-adherence to AET (e.g., low socioeconomic status, low literacy). The self-management~     intervention is administered by a nurse via the telephone, and combines the use of phone~     calls and tailored interactive voice messaging based on information exchanged during phone~     sessions and real-time adherence data obtained from smart medication bottles. Women randomly~     assigned to the control condition will receive a general health education intervention that~     is delivered by a nurse via the telephone. This study will take place in the Duke Cancer~     Institute breast clinic and in community hospitals that are members of the Duke Cancer~     Network, which will allow access to women receiving care outside the medical center setting~     and increase generalizability of findings to a variety of settings. Adherence to AET will be~     assessed over the 18 month period following study enrollment using wireless smart medication~     bottles that provide real-time adherence data. Patient-reported outcome measures assessing~     symptoms, perceived necessity of AET, concerns about AET, and self-efficacy will be obtained~     at baseline and 3, 6, 12, and 18 months. To increase the likelihood of later implementation~     of the self-management intervention, the cost effectiveness of the intervention will be~     evaluated.~   "
65668|NCT02707458|"~     DEPEND is an open-label but dosage-masked trial of the retired cholesterol-lowering drug~     probucol as an agent to increase availability of apolipoprotein E (apoE) in the cerebrospinal~     fluid (CSF) of cognitively intact older persons at risk of Alzheimer's dementia. Absorption~     of oral probucol is variable. In a sample of 23 cognitively intact persons over age 55,~     DEPEND will therefore develop an algorithm to prescribe individualized dosing to achieve~     plasma concentration that will likely increase availability of CSF apoE. These persons will~     then use their individualized dosage for 12 months to assess longer-term effects of the drug~     on CSF apoE concentration, while monitoring closely for evidence of adverse consequences of~     use.~   "
65669|NCT02707445|"~     This study evaluated epidemiology and clinical outcome of clopidogrel related various~     genotyping in Korean patients who had undergone percutaneous coronary intervention as a all~     comer registry form.~   "
65670|NCT02707432|"~     The study will determine the feasibility and efficacy of adapting an evidence-based~     intervention (EBI) to reduce cardiovascular disease (CVD) risk factors in rural African~     American communities and determine the acceptability of mobile technology in these~     communities to support behavior change.~   "
65671|NCT02707419|"~     Postoperative rehabilitation is required for a successful outcome following total knee~     arthroplasty. Traditionally rehabilitative programs aim to increase range of motion, to~     strengthen quadriceps, to restore normal gait, and to recover independence in activities of~     daily living. In the last decade action observation treatment, in addition to conventional~     physiotherapy has been proposed as a treatment method in rehabilitative medicine. There is~     growing evidence of the applicability of action observation training in rehabilitative~     medicine, indeed it has been applied in the rehabilitation of stroke of Parkinson disease of~     cerebral palsy and of aphasia.~      Nevertheless those are small studies and one of them included a mixed population of hip and~     knee arthroplasty.~   "
65672|NCT02707406|"~     The study is evaluating NEOX®CORD 1K, a cryopreserved human umbilical cord allograft.~      The purpose of the study is to evaluate the safety, incidence and rate of wound closure~     following application of the product compared to standard of care in the treatment of~     difficult to heal diabetic foot ulcers.~   "
65673|NCT02707393|"~     In children and adolescents with chronic myeloid leukaemia (CML) stem cell transplantation~     (SCT) may be a valid alternative to the life-long treatment with tyrosinkinase inhibitors~     (TKI). This trial aims to evaluate the use of a reduced intensity conditioning regimen (RIC),~     consisting of fludarabine, melphalan and thiotepa in order to minimize transplant related~     mortality and toxic late effects. Strict post-transplant monitoring and reintroduction of TKI~     as well as donor lymphocyte infusions (DLI) in case of relevant residual disease are part of~     the protocol.~   "
65674|NCT02707380|"~     This study is designed to investigate the effect of a structured resistance training program~     on glycemic control, measured by hemoglobin A1c (glycated hemoglobin), in patients with type~     2 diabetes (T2DM) who are enrolled in outpatient cardiac rehabilitation. The investigator~     will compare the experimental group receiving resistance training to a control group made of~     patients enrolled in outpatient cardiac rehabilitation and perform 3 aerobic exercise~     modalities during their sessions, which is the current standard of care.~   "
65719|NCT02706795|"~     This is an open-label, dose-escalation study to assess the safety and preliminary efficacy of~     daxibotulinumtoxinA in subjects with isolated cervical dystonia (CD).~   "
65675|NCT02707367|"~     Recovery Roadmap: A Collaborative Multimedia Tool for Person-Centered Recovery Planning is a~     highly interactive web-based tool that provides guidance for providers and people in~     recovery, and promotes widespread implementation of Person-Centered Recovery Planning (PCRP).~     The Recovery Roadmap prototype was developed and tested by the Center for Social Innovation~     (C4), in partnership with Yale University's Program for Recovery and Community Health (PRCH),~     under a Phase I Small Business Innovative Research (SBIR) grant funded by the National~     Institute of Mental Health (NIMH) (1R43MH100712). Phase II will refine the prototype Roadmap~     to streamline content, provide additional handouts and exercises for providers and clients to~     complete together, expand the audio/video vignettes and case studies, and add interactive~     online coaching and support for providers. Phase II also involves a robust evaluation of the~     Roadmap, using a quasi-experimental design in a fully powered trial. Approximately 26~     community-based mental health programs will be randomized into Recovery Roadmap (RR) or~     Illness Management and Recovery (IMR) conditions [in New York study sites, this practice is~     referred to as Wellness Self-Management (WSM)]. Participants will include both providers and~     clients, and data will include one pre-test and three post-tests with providers and clients,~     interviews with providers and administrators, network analytics, and administrative client~     data. This phase will culminate with the dissemination of findings and preparation for Phase~     III commercialization.~   "
65676|NCT02707354|"~     Gastro-intestinal graft versus host disease (GVHD) is a major source of morbidity and~     mortality amongst allogenic hematopoietic stem cell transplantation (Allo-HSCT). The~     diagnosis is based on histological findings that involve colonic biopsies with a risk of~     bleeding, especially in case of thrombocytopenia. Moreover the diagnosis is frequently made~     at a clinical stage of the disease, after the appearance of gastro-intestinal symptoms.~     Endo-microscopy is a novel endoscopic technique that allow optical biopsies during a~     conventional endoscopy and has proved its efficiency in several indications. In a pilot study~     the investigators showed that it had good sensibility and sensitivity compared to histology~     as gold standard. Therefore this study aim to identify endo-microscopic criteria allowing the~     early diagnosis of GHVD before its clinical manifestations.~   "
65677|NCT02707341|"~     The primary objective of the Corrona Psoriasis Registry is to study the comparative safety of~     approved psoriasis therapies in a North American cohort of psoriasis subjects treated by~     dermatologists. This includes assessing the incidence and nature of adverse events of special~     interest, including malignancy, in a real world population of psoriasis patients on new~     biologic therapies (e.g. secukinumab). Secondary objectives include analyzing the~     epidemiology and natural history of the disease, comorbidities, current treatment practices,~     and comparative effectiveness.~   "
65678|NCT02707328|"~     This study is looking at determining the maximum safe dose of CyberKnife when given with~     chemotherapy for unresectable adenocarcinoma of the pancreas.~   "
65679|NCT02707315|"~     This study is evaluating stereotactic radiosurgery (CyberKnife) plus chemotherapy for the~     treatment of potentially resectable adenocarcinoma of the pancreas~   "
65680|NCT02707302|"~     The purpose of this study is to support the rational use of iodophor-impregnated surgical~     adhesive drapes for preventing wound infections after total hip arthroplasty.~   "
65681|NCT02707289|"~     Up to two hundred un-identified PillCam SB movies will be collected from 2 clinical sites,~     during up to 3 years and transferred to Given Imaging. Demographical data and medical history~     will be collected. Capsule transit time in the different sections of the GI will be~     evaluated.~   "
65682|NCT02707276|"~     The primary aim of this study is to assess the efficacy of Low Field Magnetic Stimulation~     (LFMS) in treating symptoms of depression and anxiety in older adults suffering from bipolar~     depression. The investigators also aim to assess any cognitive benefits from regular LFMS~     treatments in older adults suffering from bipolar depression.~   "
65683|NCT02707263|"~     The primary purpose of this study is to demonstrate that a continuous infusion of intravenous~     (IV) heparin (UFH) for Venous thromboembolism (VTE) prophylaxis will restore prophylactic~     levels of heparin in high-risk critically ill medical patients as compared with guideline~     recommended subcutaneous heparin. Antifactor Xa assay, a laboratory test to measure the~     anticoagulant activity of heparin, or the ability of heparin to thin the blood, will be used~     to demonstrate that Intravenous administration is more effective.~   "
65684|NCT02707250|"~     Laparoscopic cholecystectomy although a minimally invasive procedure, may be accompanied by~     considerable pain after surgery. More recently transversus abdominis plane (TAP) block was~     extensively studied as a potential analgesic maneuver after laparoscopic cholecystectomy. The~     subcostal approach (OSTAP block) is a variation on the TAP block that produces reliable~     supraumbilical analgesia.~   "
65685|NCT02707237|"~     Providing verbal counseling supplemented with both written and pictorial information then~     verbal counseling alone is a more effective method of counseling parents with threatened~     preterm delivery~   "
65686|NCT02707224|"~     A randomized, single-dose, open, crossover clinical trial to compare the pharmacokinetics of~     DP-R208 (Candesartan cilexetil and Rosuvastatin calcium fixed dose combinations) in~     comparison to each component administered alone in healthy male volunteers~   "
65687|NCT02707211|"~     To test whether active pneumococci immunization can alleviate inflammation and improve~     cholesterol metabolism in lysosomal lipid storage diseases and associated metabolic~     disorders.~   "
65688|NCT02707198|"~     This study is being conducted to investigate the potential benefits of probiotic intake for~     preventing antibiotic associated diarrhea and Clostridium difficile infection in patients~     undergoing a systemic antibiotic treatment. The primary research question is: can daily~     intake of kefir, a yogurt-like food containing probiotics, reduce the incidence of diarrhea~     and Clostridium difficile infection in patients during antibiotic treatment?~   "
65867|NCT02704858|"~     NEO100-01 is a Phase 1/2A study of the monoterpene, perillyl alcohol (NEO100)in patients with~     recurrent glioblastoma. NEO100 is delivered four times a day by intranasal administration~     using a nebulizer and nasal mask for up to 6 months. Four escalating doses will be evaluated~     for tolerability, and the maximum tolerated dose will be extended in the 2A phase for a total~     of 25 patients. There is no concurrent control. This is the first nasal administration in the~     US, after prior oral studies with perillyl alcohol proved ineffective. Nasal administration~     of perillyl alcohol is on-going in Brazil~   "
65689|NCT02707185|"~     METHODS:~      Subjects:~      All internal medicine (IM), emergency medicine (EM), anesthesia (A), surgery (S) residents~     and all hospital ICU nurses (approximately 400 subjects) will be undergoing evaluation and~     training in CPR techniques according to their department training policy.~      Study Assessment Tool:~      An objective assessment tool has been developed and tested in medical code scenarios during~     training sessions recently done in the simulation lab. The tool has five domains: Airway,~     Breathing, Circulation, Communications/Leadership, and Defibrillation. Each domain consists~     of 3-8 tasks and skills (attachment A).~      Design:~        -  Phase I: In groups of five to six subjects, residents and nurses will undergo baseline~          assessment in CPR techniques in the simulation lab. Subject will be presented with a~          clinical scenario that includes cardiopulmonary arrest. Subjects will be scored by~          observers based on the previously described assessment tool and will be video recorded.~        -  Phase II: All study subjects who completed phase I assessment will undergo standardized~          debriefing and demonstration of proper CPR techniques after reviewing their individual~          baseline videotape followed by repeated demonstration in CPR techniques during a~          clinical scenario with cardiopulmonary arrest in the simulation lab. Knowledge retention~          will be assessed periodically.~        -  Phase III: Rates of survival to hospital discharge and survival at 24 hours in~          hospitalized patients after cardiopulmonary arrest collected by the CPR committee and QA~          department longitudinally for one year after completion of project training (phase II)~          will be reviewed and compared to the same period one year earlier (CPR outcome data are~          being collected since 2005 at St. Luke's-Roosevelt Hospitals).~   "
65690|NCT02707172|"~     The aim of the study is to evaluate the effectiveness in removing chemical exposure on hand,~     the investigators compare removal efficiency of Di-(2-ethylhexyl)phthalate (DEHP) on hands by~     hand washing with soap and water vs. water only. In two three-day N-of-1 trials, residual~     DEHP was measured in a single female adult who washed exposed hands with soap-and-water or~     water-only. Subsequently, a crossover study was performed by randomly assigning another 28~     subjects equally to wash with soap-and-water or with water-only, and then each one received~     the other treatment 24 hrs later.~   "
65691|NCT02707159|"~     The majority patients diagnosed with pancreatic cancer have metastatic disease at the time of~     diagnosis. The prognosis is extremely poor with a 5-year survival rate of less than 5%.~     Treatment with chemotherapy can improve efficacy, but still the median progression-free~     survival in patients receiving nab-paclitaxel and gemcitabine is only 5,5 months and median~     overall survival is less than one year. There is a urgent need for tools for predicting the~     efficacy of the treatment. The current trial aims at investigating the biomarker potential of~     circulating tumor cells (CTCs) in metastatic pancreatic cancer patients treated by~     gemcitabine and nab-paclitaxel.~   "
65692|NCT02707146|"~     This project focuses on improving the patient-provider primary care visit interaction by~     addressing the need to align patient and provider priorities in a way that incorporates~     patients' goals and preferences while supporting the clinical work of their providers.~   "
65693|NCT02707133|"~     Choroidal nevomelanocytic lesions have a high prevalence affecting up to 7% of the entire~     population and are increasingly incidentally identified during routine eye check- ups in~     community optometry services. Given the tendency to err on the side of caution, there is~     evidence of excessive referrals challenging service delivery in both tertiary eye units and~     specialist ocular oncology services. Although previous studies have examined the natural~     history and risk factors for growth of choroidal nevomelanocytic lesions, optimal delivery of~     management remains uncertain. Management approaches display diversity with respect to the~     number and type of baseline investigations, the duration and frequency of monitoring of~     relevant patients. Utilisation of the skills of allied health professionals in appropriate~     cases would allow streamlining service delivery in a socialised healthcare system, maximise~     capacity, and allow community services to play an enhanced role. However, the evidence for~     this model of delivery is lacking. Within existing models of care for these lesions, patients~     are faced with delays, need for more than one attendances to the hospital and increased~     anxiety around prognosis.~      This project aims to answer the question of whether these low-risk, bland incidental findings~     might possibly be managed by allied health professionals with the use of clinical imaging and~     specific algorithms to make appropriate management decisions. We aim to validate a model of~     service delivery on a virtual basis that will accommodate for capacity pressures to accept~     all relevant referrals, while offering a safe service and optimising patient experience of~     care. We will thus validate the setting up of a virtual choroidal nevomelanocytic clinic in~     terms of safety and patient acceptability. More specifically, the degree of agreement between~     management decisions made by non-medical graders on the basis of imaging data alone as~     opposed to gold standard decisions (clinical and imaging tests combined) is examined. Health~     economics analysis of the proposed service delivery model will be undertaken to demonstrate~     cost-effectiveness.~   "
65694|NCT02707120|"~     Neurotrophic keratitis (NK) is a rare degenerative corneal disease caused by altered~     innervation of the trigeminal nerve that leads to rupture of the corneal epithelium, the~     regeneration deterioration and development of corneal ulceration, their fusion, and~     perforation The main characteristic in the NK is a decrease or absence of corneal~     sensitivity.~   "
65695|NCT02707107|"~     Study to evaluate the safety, tolerability and pharmacokinetics of multiple escalating doses~     of intravenous WCK 5222 (Zidebactam and Cefepime) in healthy adult human subjects.~   "
65696|NCT02707094|"~     The purpose of this study is to determine the efficacy of self treatment with the~     Biomodulator device to decrease chronic low back pain (LBP) in active duty service members.~     In addition, the study will track the use of pain medication and the impact of pain on~     symptoms of anxiety, depression and Post Traumatic Stress Syndrome (PTSD).~   "
65697|NCT02707081|"~     Objective: To evaluate intraperitoneal (IP) lidocaine administration and intravenous (IV)~     lidocaine infusion for postoperative pain control after cesarean section.~      Study design: prospective randomized, double-blind, placebo-controlled study. Patients and~     methods: Initially, 165 pregnant full-term females, indicated to be underwent elective~     cesarean delivery for various indications were randomized equally to either group C (control,~     IP and IV saline), group IP (intraperitoneal lidocaine administration), or group IV~     (intravenous lidocaine infusion).Five patients were excluded from each group for various~     reasons. The outcome measures were postoperative pain scoring, total pethidine consumption~     and the need for postoperative analgesia.~   "
65698|NCT02707068|"~     This study seeks to test the feasibility of a self-management manual with minimal telephone~     support by a healthcare professional. The study will also explore the acceptability of the~     intervention manual to patients.~   "
65879|NCT02704702|"~     The purpose of this study is to evaluate the pharmacokinetics and safety of Fimasartan and~     rosuvastatin when coadministered or administered alone as a single dose or as multiple doses~     to healthy male subjects.~   "
65699|NCT02707055|"~     Background:~      Hormones are naturally occurring chemicals in the body. Ghrelin is a hormone that stimulates~     appetite. It may also stimulate alcohol cravings and use. Researchers want to learn more~     about alcohol cravings and test if a drug that blocks ghrelin lowers alcohol cravings.~      Objective:~      To test if the drug PF-05190457 decreases alcohol craving.~      Eligibility:~      People ages 18 65 who have:~      Alcohol use disorder~      No other serious medical problems~      Woman must be postmenopausal or have had surgery to prevent pregnancy.~      Design:~      Participants will stay on the inpatient unit here at the Clinical Center for two 2-week~     stages, which will be separated by at least 2 days. The inpatient phase include:~      Taking the study drug or placebo by mouth twice daily~      Blood tests~      Tasting several sweet solutions~      Physical exams~      Smokers will smoke cigarettes through a device that gives information about how they smoke a~      cigarette.~      Exposure to alcohol, water, and food cues in a bar-like room. Participants answer questions~     on a computer.~      Blood pressure and heart rate are monitored through an arm cuff and sensors on the chest.~     Saliva is collected~      through cotton rolls in the mouth.~      MRIs: Participants lie on a table that slides in and out of the cylinder, and a coil is~     placed over the head.~      They complete tasks on a computer screen while in the cylinder. This lasts up to 2 hours.~      Wearing a virtual reality headset, walking around a virtual room, and selecting virtual food~     and drink.~      Participants will have 8 hour long follow-up visits in our Outpatient Clinic These include:~      Counseling to abstain from alcohol use. Sessions may be videotaped.~      Physical exams~   "
65700|NCT02707042|"~     More than 250 million courses of antibiotics are prescribed annually in the ambulatory care~     setting in the United States alone, including more than 40 million in children under 18 years~     of age. The perception that antibiotic use has minimal attendant adverse side effects~     contributes to the over-utilization of antibiotics in clinical circumstances when they are~     not strictly indicated. We have learned much about the human microbiome. The emerging view is~     of profound life-long bi-directional interactions between our microbiota and our cells.~     Perturbations in the microbiota affect metabolic, immune, and cognitive physiology in~     experimental animal models. When a person takes an antibiotic, the antibiotic diffuses via~     the blood into all body compartments, selecting for resistance. We propose to examine the~     effects of two commonly used antibiotics (the beta-lactam, amoxicillin and the macrolide~     azithromycin) on human microbial populations and on metabolic and immune physiology, studying~     healthy human volunteers in a randomized controlled clinical trial at the NIH Clinical~     Center. Our hypothesis is that in addition to acutely perturbing the human microbiome, these~     agents will have measurable metabolic and immunologic effects, with residual effects in the~     weeks that follow. To test this hypothesis, we will assess the effects of a brief therapeutic~     course of antibiotics on microbiome and metagenome composition. After an initial evaluation~     period, antibiotics will be given for 7 days or 5 days (depending on the antibiotic), and~     there will be a post-treatment evaluation. A control group will receive no drug intervention.~     Specimens will be obtained from multiple sites at each of 10 time points occurring before,~     during, and after antibiotic administration, and used for estimating bacterial and fungal~     composition and gene content. We will also assess the effects of the antibiotic course on~     markers of innate and adaptive immunity as well as markers of metabolic and hormonal~     physiology. A subgroup of subjects will be studied in the clinical center metabolic chamber~     to assess 24-hour energy expenditure and its components (sleeping, diet-induced, and activity~     energy expenditure), as well as macronutrient oxidation rates (carbohydrate, fat, and~     protein), during 3 of the 10 study visits. In addition to the primary data analyses, we will~     build a model that integrates the temporal data to begin to understand the complex~     intertwined physiology between microbiome and host.~   "
65701|NCT02707029|"~     Background:~      Researchers want to better understand pain by studying people with and without different~     kinds of pain. To do this, researchers will expose people to pleasant and unpleasant~     sensations. They will ask them questions about their pain. Researchers also want to see if~     these people are eligible for other research studies at the National Center for Complementary~     and Integrative Health.~      Objectives:~      To study the experience of pain. Also to find people eligible to join other NIH studies.~      Eligibility:~      People 12 years and older with and without pain disorders.~      Design:~      Participants will be screened by phone.~      Participants will have one required visit. This may include:~        -  Medical history~        -  Physical exam~        -  Questionnaires about themselves and their pain experience~        -  Blood and urine tests~        -  MRI: They will lie on a table that slides into a cylinder. They will feel different~          sensations while completing tasks on a computer. This lasts 15 minutes to 2 hours.~        -  Quantitative sensory testing: They will be exposed to different pictures, sounds,~          tastes, and smells. They will also be exposed to pleasant and unpleasant sensations.~          These could include:~             -  Burning, itching, or cold sensations~             -  Pinpricks~             -  Pressure and pinches~        -  Electrocardiogram: Stickers on the chest record heart activity.~        -  Straps placed around the chest to measure breathing.~        -  Small sensors on the fingers or palms to measure pulse and sweating.~      Over the next 3 months, participants may have up to 4 other study visits. These last 2 to 4~     hours each. They include repeats of some of the tests in the required visit.~      Participants may be recorded at the visits.~   "
65702|NCT02707016|"~     The investigators aim to reduce the incidence of emergence delirium in children aged 2-7~     years old by using two different doses of sevoflurane during inhalatory induction of~     anesthesia.~   "
65703|NCT02707003|"~     Multi-center observational trial with study device blinded in order to assess in parallel~     standard monitoring and intervention practices related to management of respiratory~     compromise in the post-anaesthesia care unit (PACU)~   "
65704|NCT02706990|"~     The aim of this study is to evaluate the in vivo kinematics of TKA performed with two~     different prosthesis: a kinematic retaining (Physica KR) and a posterior-stabilized (Physica~     PS) design by means of fluoroscopic analysis during activities of daily living (rising from a~     chair, stairs climbing, leg extension). In comparison with asymptomatic knee. Patterns of~     femoral rollback will be analyzed to assess if they are motor-task dependent and correlated~     with clinical outcomes.~   "
65705|NCT02706977|"~     The purpose of this study is to evaluate the use of electroretinogram (ERG) using a novel~     handheld system, RETeval, and evaluate contrast sensitivity testing in detecting pre-clinical~     retinopathy on a tablet device.~      Investigators also seek to assess if a medication called Sinemet™ CR can improve the~     electrical functions of the eye in participants with diabetes mellitus. This study will~     include a total of 45 participants; 30 with diabetes mellitus and 15 age-matched non-diabetic~     controls. Participants with diabetes mellitus and electroretinogram (ERG) delays will be~     randomized to a low or high dose Sinemet CR group.~   "
65880|NCT02704689|"~     This is a post-market clinical study of the AccuLIF expandable transforaminal lumbar~     interbody fusion (TLIF) cage in patients requiring surgery for degenerative disc disease~     (DDD) with up to Grade I spondylolisthesis or retrolisthesis, at one or two levels, between~     L2 and S1.~   "
65881|NCT02704676|"~     The Aim of this study is to determine the relationship between serum concentrations of cancer~     antigen-125 (CA-125) and pre-eclampsia severity.~   "
65706|NCT02706964|"~     Currently, once a distant breast metastasis has been diagnosed, 65% of patients will succumb~     to their cancer within 2 years, and 80% will succumb by 5 years. The current National~     Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Breast Cancer do not~     recommend surveillance imaging for earlier detection of distant metastases, even for~     high-risk breast cancer patients. Whereas, the standard-of-care treatment of the small~     isolated (few in number) breast cancer metastases is to perform surgical resection or locally~     ablative radiation therapy, however, the follow-up of breast cancer patients (including those~     with a >= 30% risk of developing metastases) is to wait for clinical symptoms to appear~     before using a dual positron emission tomography (PET) and diagnostic quality computed~     tomography (CT) PET/CT scan, magnetic resonance imaging (MRI), computed tomography (CT) or a~     bone scan to identify the site and extent of spread. Unfortunately, once metastases become~     symptomatic they are often too large and/or numerous to treat with curative intent. The~     current national care guidelines that advocate against intensive surveillance for distant~     metastases are based on two studies performed in Italy from 1985-1993 that concluded that the~     available imaging and treatment tools of the day did not prolong 5-year survival. Since then,~     however, there have been major improvements in imaging and treatment technology. To be~     treatable the metastases must be limited in number and limited in size, typically 6 or fewer~     metastases, each of size 5 centimeter or less. This state of metastatic presentation is~     called oligometastases. Numerous pilot studies have achieved dramatically improved overall~     and disease-free survival when oligometastases are treated using a combined systemic plus~     locally-ablative therapy of each oligometastasis. A scientific concern with the~     aforementioned research studies involving ablation of isolated oligometastases, was that they~     were not carried out with consistent use of surveillance imaging. Instead, these studies~     effectively preselected patients for enrollment based upon having an existing oligometastatic~     presentation. The primary objectives of the research study are to: (1) determine the~     feasibility of the stated interventions in a multi-institutional setting; (2) document the~     patterns of early metastatic spread of breast cancer; (3) document the proportion of~     high-risk breast cancer patients that have an oligometastatic presentation within this~     proactive imaging protocol, and (4) provide a basis to determine how to optimize future~     surveillance imaging protocols with respect to the time to progression, rate of tumor growth~     and organs that are affected.~   "
65707|NCT02706951|"~     This is a randomized, double-blind study comparing ABT-494 monotherapy to Methotrexate (MTX)~     monotherapy in subjects with moderately to severely active rheumatoid arthritis who have had~     an inadequate response to methotrexate treatment.~   "
65708|NCT02706938|"~     BACKGROUND: Gastroesophageal reflux disease is a very frequent clinical condition and~     nocturnal symptoms are a cause of quality of life impairment, poor sleep quality and~     absenteeism. Head of bed elevation, as a low-cost non pharmacologic anti-reflux treatment is~     nowadays recommended, but its clinical impact in patients with nocturnal symptoms remains~     unknown due to inconsistent results and methodological limitations among different clinical~     trials, most of which were performed before the widespread use of proton pump inhibitors in~     clinical practice.~      HYPOTHESIS: Head of bed elevation is a useful treatment for patients with gastroesophageal~     reflux disease and nocturnal symptoms, and has a positive impact in quality of life in these~     patients.~      STUDY OBJECTIVE: To assess the effectiveness of head of bed elevation for treatment of~     patients with gastroesophageal reflux disease and nocturnal symptoms, and to determine the~     impact of this intervention in quality of life of these patients.~      METHODS: Randomized single-blind single-centre controlled clinical trial with a 2x2~     cross-over design. A sample of 124 patients attending to the outpatient gastroenterology unit~     at Clínica Fundadores in Bogotá city, who meet the inclusion criteria and have no exclusion~     criteria will be selected to participate. Included patients will be randomized to raise the~     head of bed with standard 20 cm-height wooden blocks or to sleep without bed inclination~     during the first 6 week period. After a 2 week washout period, allocation will be crossed and~     participants will be followed again during a second 6 week period. During the trial, every~     patient will receive standard pharmacological treatment with a proton pump inhibitor and/or~     sodium alginate. After allocation concealment, the researchers in charge of statistical~     analysis and reporting results will be blinded for the non pharmacological intervention under~     study. Primary outcome is a significant symptom change according to Reflux Disease~     Questionnaire (RDQ) validated form. Secondary outcomes include impact on quality of life~     according to Short Form 36 (SF-36) validated questionnaire, patient preference and adverse~     events of non-pharmacological intervention. Statistical analysis will be carried out with the~     Statistical Package for Social Sciences (SPSS) 16.0 for Windows. Differences with a p<0,05~     will be accepted as statistically significant.~   "
65709|NCT02706925|"~     To investigate safety, tolerability and pharmacokinetics, following single doses of BI 443651~   "
65710|NCT02706912|"~     Virtual Occupational Therapy Application (VOTA) combines low-cost human motion tracking,~     commercial game engine technology, and evidence-based Occupational Therapy (OT) practice in a~     computer-based virtual world in which stroke patients practice activities of daily living~     (ADLs). The protocol investigates the efficacy of VOTA therapy for Upper Extremity (UE) motor~     recovery and assesses system usability and user acceptance.~   "
65711|NCT02706899|"~     This is a phase 1/2 study to evaluate the combination of vadastuximab talirine (SGN-CD33A;~     33A) and azacitidine in subjects with previously untreated International Prognostic Scoring~     System (IPSS) Intermediate-2 or high risk myelodysplastic syndrome (MDS).~   "
65712|NCT02706886|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and~     pharmacodynamics of single- and multiple-ascending doses of ALN-GO1 in healthy adult~     volunteers and subjects with PH1.~   "
65713|NCT02706873|"~     This is a randomized, double-blind study comparing ABT-494 monotherapy to Methotrexate (MTX)~     monotherapy in MTX-naïve subjects with moderately to severely active rheumatoid arthritis~   "
65714|NCT02706860|"~     This study aims at comparing different perioperative statin regimens for the prevention of~     post CABG adverse events.~      This was a randomized, prospective clinical trial. Ninety four patients scheduled for~     elective, isolated on- or off- pump CABG were randomly assigned to one of 3 treatment groups;~     80 mg atorvastatin/day for 2 days preoperatively (N=37), 80 mg atorvastatin/day for 5-9 days~     preoperatively (N=28) or 40 mg atorvastatin/day for 5-9 days preoperatively (N=29). The~     corresponding preoperative doses were restarted postoperatively (post-op) when patients were~     able to take the medication orally and were continued for one month. Cardiac troponin I~     (TnI), Creatine Kinase (CK-MB) and C-reactive protein (CRP) were assayed preoperatively and~     post-operatively at 8, 24, 48 hours, and at discharge. Marker levels were compared among the~     three groups. The incidence of post-operative major adverse cardiac and cerebrovascular~     events (MACCE) was assessed including; 30-day all-cause mortality, myocardial infarction,~     atrial fibrillation, ventricular tachycardia/ventricular fibrillation, stroke and~     target-vessel revascularization. The incidence of renal or hepatic impairment and~     post-operative infections were also assessed. A Quality of life (QoL) questionnaire~     (EQ-5D-3L) was administered preoperatively and 1 month after CABG.~   "
65715|NCT02706847|"~     The comparison of safety and efficacy of two doses of Upadacitinib (ABT-494) versus placebo~     in participants with rheumatoid arthritis on a stable background conventional synthetic~     Disease Modifying Anti-Rheumatic Drug (csDMARD).~   "
65716|NCT02706834|"~     The purpose of this study is to evaluate the safety and tolerability of single oral doses of~     TAK-828 in healthy non-Japanese and Japanese participants.~   "
65717|NCT02706821|"~     The investigators performed a 8-week, randomized, double-blind, placebo-controlled crossover~     human trial to evaluate the efficacy and safety of persimmon leaf extract on blood glucose.~     The investigators measures changes in diabetes associated parameters, including fasting blood~     glucose, postprandial blood glucose, insulin, C-peptide and HbA1c.~   "
67702|NCT02680756|"~     The purpose of this study is to compare the efficacy of ferric maltol and intravenous iron~     (IVI) Ferric Carboxy Maltose in the treatment of iron deficiency anaemia (IDA) and subsequent~     maintenance of haemoglobin in subjects with Inflammatory Bowel Disease (IBD).~   "
65720|NCT02706782|"~     Pancreatic carcinoma typically has a high recurrence rate and very poor prognosis. Surgery is~     the best choice for the treatment of pancreatic cancer, but for those advanced pancreatic~     cancer patients，when surgery is not available，chemotherapy combined with radiation therapy or~     interventional therapy is commonly used in the treatment，but the prolonging survival effect~     is not obvious. And now, some clinical researchers use CAR-T cells in the treatment of~     pancreatic carcinoma, according to the existing results, therapeutic effects are not as good~     as expecting. One of the most likely reasons is that they continued to use the intravenous~     infusing of CART cells to patients, when the T cells into the blood circulation, will result~     in decreased tumor activity and more potential adverse effects. We believe that a suitable~     TAA targeted-CAR-T cells will be an effective way to treat cancer, as long as the pathway of~     the cell infused to the body can not only improve the drug concentration of the tumor site~     but reduce the potential off-target side effects. In order to achieve this goal, it is~     probably the best choice to use vascular intervention to mediate CAR-T cells infusion.~     Mesothelin is a cell-surface antigen implicated in tumor invasion, which is highly expressed~     in pancreatic carcinoma but low-level expressed in mesothelia. We design a 2nd CART cells~     targeted with mesothelin, and use vascular intervention mediated CAR-T infusion to patients.~     We hope deliver anti-mesothelin CART cells locally can reducing the side effects while~     enhancing the antitumor affect by more CART cells accumulate in tumor sites while less can~     reach normal mesothelial tissue.~   "
65721|NCT02706769|"~     National guidelines advocate the use of paracetamol in conjunction with strong opioids for~     cancer pain, despite a lack of evidence for its efficacy. Work is needed to examine the~     analgesic benefit of paracetamol in this large patient group. The investigators aim to~     establish if paracetamol in combination with strong opioids provides superior analgesia for~     cancer related pain over strong opioids alone.~   "
65722|NCT02706756|"~     1. Purpose: 1) compare three conservative treatment approaches for subjects with~          femoroacetabular impingement syndrome (FAI), and 2) analyze functional outcome~          comparatively across groups.~        2. Interventions will be provided based on randomized assignment. Group 1 will receive~          treatment based on identified impairments and treated twice weekly to address said~          impairments with hip manual therapy and exercise, as well as a prescriptive exercise for~          strengthening and mobility of the hip. Group 2 will receive only the prescriptive~          exercise program. Group 3 will be a control group (supervised neglect)~        3. Primary outcomes data analysis will involve a mixed design (repeated measures) ANOVA for~          assessment of the primary outcome measure of the HAGOS. Secondary analyses will include~          chi square analyses (PASS, surgery at 6 months, adverse events), ANCOVA (PPMs, and~          expectations measures), or other appropriate comparative measures. None of the proposed~          treatment is considered outside of 'standard of practice'.~   "
65723|NCT02706743|"~     The aim of this study was to assess the impact of adjuvant radioactive iodine therapy on the~     quality of life(QOL) in differentiated thyroid cancer patients and to identify independent~     factors affecting changes in the QOL.~   "
65724|NCT02706730|"~     This is an open-label extension study of a single intratympanic injection of OTO-104 given~     every 3 months for a total of 2 injections. Subjects must have completed either Otonomy study~     104-201102 (Phase 2b study of OTO-104) or 104-201506 (Phase 3 study of OTO-104) in order to~     be eligible for this open-label extension study.~   "
65725|NCT02706717|"~     The purpose of the study is to evaluate whether the probiotic Visbiome Extra Strength reduces~     inflammation in HIV-infected men and women when compared to a placebo (inactive medication~     like a dummy pill). The study will evaluate whether taking Visbiome Extra Strength by mouth~     for 24 weeks is safe and well-tolerated for HIV-infected persons on antiretroviral therapy~     (ART). Probiotics are germs such as yeast or bacteria that are found in food and supplements~     that are used to improve the health of the digestive system. Many people refer to probiotics~     as helpful bacteria. These bacteria live in the body and help the body work normally. In~     some medical conditions, including HIV infection, helpful bacteria are replaced with bacteria~     that can change the normal intestinal function and increase inflammation. The investigaors~     will test whether giving a probiotic can restore normal intestinal function and decrease~     inflammation.~   "
65726|NCT02706704|"~     The objective of this study is to compare and evaluate the efficacy of subcutaneous (40mg)~     adalimumab biweekly injections to intravitreal adalimumab (1.5 mg/ 0.03 mL) administration,~     given at zero, 2 weeks then every four weeks, in subjects with active non-infectious~     intermediate-, posterior-, or pan-uveitis.~   "
65727|NCT02706691|"~     This phase IIa trial studies how well pan fibroblast growth factor receptor (FGFR) kinase~     inhibitor BGJ398 works in treating patients with FGFR1-3 translocated, mutated, or amplified~     head and neck cancer that has returned after a period of improvement. Pan FGFR kinase~     inhibitor BGJ398 may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth.~   "
65728|NCT02706678|"~     The objective of this study is to evaluate the effects of tacrolimus sustained-release~     capsules replacing cyclosporin on kidney function of renal transplant recipients.~   "
65729|NCT02706665|"~     The purpose of this study is the evaluation of possible relationships and correlation between~     PSI values obtained from the SEDLine® monitor and the infusion rate of propofol during~     general anesthesia.~   "
65730|NCT02706652|"~     Background:~      People's genetic markers and other genetic characteristics can affect their response to drug~     therapy. Researchers want to screen people for these markers and characteristics. They want~     to do this before the people are screened for studies at the National Cancer Institute. That~     should save time that can be lost when people go through the whole screening for a study only~     to find out they cannot join. The data collected may also be used to select the proper dose~     of anticancer agents that are being studied.~      Objective:~      To screen people for genetic markers and/or baseline characteristics. These will be used to~     determine if they can enroll in a clinical trial. They may also be used to select the proper~     dose of anticancer agents that are being tested.~      Eligibility:~      Adults 18 and older who are being considered for or being treated in a National Cancer~     Institute study~      Design:~      Participants will have their blood drawn for genetic tests.~      Some participants will have a cheek swab.~      Participants genetic data will be stored for future research. It could be shared with other~     researchers.~   "
65731|NCT02706639|"~     Background:~      DNA tells the body how to grow and function. Williams-Beuren syndrome (WS) and Supravalvular~     Aortic Stenosis (SVAS) are rare diseases caused by changes in a part of a person s DNA.~     Symptoms of both conditions include vascular problems including narrow blood vessels and~     supravalvular aortic stenosis (SVAS) or supravalvular pulmonary stenosis. Individuals with WS~     may also have developmental challenges and personality differences. Researchers at the NIH~     want to find out why only some people with WS and SVAS have severe symptoms. They want to~     collect samples and data to see what DNA or environmental changes affect the severity of the~     disease.~      Objective:~      To identify the DNA differences or environmental changes that change the severity of WS and~     SVAS from person to person.~      Eligibility:~      People ages 0 85 with either WS, SVAS, and/or an SVAS-like condition~      Children and people with WS must have a parent or legal guardian to consent or help answer~     questions.~      Design:~      Participants will be screened with questions and medical history.~      Participants will have a 60-minute visit. They will provide blood or saliva samples.~      They or their parent/guardian will:~      Answer questions about how WS and SVAS affect them.~      Sign a form releasing their medical records for the study.~      If participant s regular doctor recommends surgery, researchers will ask the surgeon for skin~     or tissue samples that they might otherwise discard. These will be used to create stem cells~     to study in a lab.~      For up to 20 years, participants will have annual questionnaires by phone, email, or mail~     about their WS or SVAS.~      Participants may also be contacted if:~      They need to provide a new blood or saliva sample.~      Researchers need any other data.~      There is a follow-up study.~   "
65732|NCT02706626|"~     The purpose of this study is to evaluate the safety and effectiveness of this investigational~     drug, brigatinib (AP261136) in patients with advanced non-small cell lung cancer Non-small~     cell lung cancer (NSCLC) who have had first-line treatment for their cancer and it still got~     worse, even after, or while taking drugs called ALK inhibitors, or anti-cancer drugs that act~     on tumors. Some examples of these anti-cancer drugs are: KEYTRUDA® or ALECENSA®).~   "
65733|NCT02706613|"~     Over time, patients with COPD (Chronic Obstructive Pulmonary Disease) develop progressive~     symptoms of breathlessness, which can limit day-to-day activities and tolerance to exercise.~     Pulmonary Rehabilitation (PR) is an established intervention in the management of COPD and is~     a structured programme of exercise training and education. Pulmonary Rehabilitation~     encourages and enables patients to improve their exercise capacity incrementally over the~     course of a six-week programme. An established evidence base has placed PR at the centre of~     interventions for COPD and its provision is mandated by NICE as a key pillar of integrated~     care.~      Currently, the provision of PR in the NHS is limited to group sessions run over an~     established protocol of 6 weeks. Whilst this has been demonstrated to improve exercise~     capacity, access to PR classes can be problematic for some patients. Also, staff and facility~     resources limit delivering the programme at scale. An online PR programme developed by my~     mhealth known as 'myPR', in consultation with patients and physiotherapy experts, offers an~     alternative provision of this important intervention.~      The study aims to compare this online PR programme to conventional face-to-face PR as~     currently delivered by the NHS. The study aims to recruit 106 patients referred for PR from~     Portsmouth Hospital and local Participant Identification Centres.They will then be assessed~     for suitability onto PR, consented and randomised onto an arm of the study. 36 will undertake~     a conventional PR programme as reflected in the NHS, and 70 the online PR programme known as~     'myPR'. Pre and post programme measurements including walking distance and quality of life~     questionnaires will then be compared between each arm of the trial, to ensure that the online~     PR is not inferior to the conventional face-to-face PR.~   "
65734|NCT02706600|"~     There are currently 900,000 people in the UK with a diagnosis of Chronic Obstructive~     Pulmonary Disease (COPD), The disease is progressive and often causes disabling symptoms such~     as chronic cough, breathlessness and reduced tolerance to exercise. National Institute for~     Health and Care Excellence (NICE) recommends that patients with COPD have a self management~     plan (SMP). The utilisation of SMP's has been shown to reduce healthcare utilisation, improve~     quality of life, and reduces the need for hospitalisation. Currently SMP's are delivered to~     patient in a paper format, myCOPD is a web based self management system which has been~     developed by Healthcare professional and patients encompasses the principles of Self~     management and offers a viable solution to a national recommendation.~      The study will compare paper self management plans against the online version myCOPD. The~     study aims to recruit 60 patients with a diagnosis of COPD during their admission to hospital~     for an exacerbation or flare up of their COPD. Patients will be given an information sheet~     during their admission and prior to leaving hospital be asked if they wish to participate in~     the study. Patients will participate in the study for no less than two months and a maximum~     of three months. 30 patients will receive written self management and 30 will receive online~     self management. There will be a total of 4 visits for the duration of the study.~      The screening visits will comprise of written or verbal consent, Demographics, Medical,~     exacerbation and healthcare utilisation history, Quality of Life questionnaires, inhaler~     technique assessment and delivery of either a written self management plan. The telephone~     visits will comprise of verbal consent and completion of the COPD Assessment Test. The End of~     Study visit will comprise of verbal consent, Demographics, Medical, exacerbation and~     healthcare utilisation history, Quality of Life questionnaires and assessment of inhaler~     technique.~   "
65735|NCT02706587|"~     The purpose of this study is to determine whether early neuromuscular electrical stimulation~     is effective in the prevention of neuromuscular weakness in critical ill patients.~   "
65736|NCT02706574|"~     The goals of this study are to develop an objective, multi-modal classification scheme and~     outcome measures for traumatic brain injury based on several measures: (1) blood-based~     biomarkers (indicates which cell types are damaged), (2) eye tracking (detects mass~     effect/elevated intracranial pressure and pathway disruption), (3) radiographic measures of~     CT and MRI (detect structural abnormalities), and (4) standardized outcome assessments.~   "
65737|NCT02706561|"~     The purpose of this study is to test two different ways to help men with sexual~     rehabilitation.~   "
65738|NCT02706548|"~     Many persons with chronic health conditions fail to take their medications as prescribed,~     resulting in declines in health and function. Unfortunately, current interventions for~     medication nonadherence are not very effective. This objective of this study is to test a new~     intervention, the Integrative Medication Self-management (IMedS) intervention to improve~     medication adherence in adults with chronic health conditions.~   "
65882|NCT02704663|"~     In cases of benign adnexal mass laparoscopic surgery, women were randomized to two groups:~     transumbilical vs. transabdominal removal. Need for pain medication, postoperative pain and~     patients´ satisfaction were assessed between the groups, as well as surgeons´ opinions and~     costs.~   "
65904|NCT02704377|"~     This pilot clinical trial studies quality of life and supportive care preferences following~     radiation therapy in prostate cancer survivors. Studying quality of life and supportive care~     preferences in patients undergoing radiation therapy may help identify the effects of~     treatment on patients with prostate cancer.~   "
65739|NCT02706535|"~     This is a Phase I, single center, two-part, randomized, open label, cross-over study. Part 1~     of this study will evaluate the PK, safety, and tolerability of GSK525762 when administered~     alone and when co-administered following repeat dosing of itraconazole, a known strong~     inhibitor of Cytochrome P450 3A4 (CYP3A4) and a Para-glycoprotein (Pgp) inhibitor. Part 1~     will consist of 2 Cohorts with preliminary PK and safety data obtained from Cohort 1~     informing Cohort 2. Part 2 (one Cohort) of the study will evaluate the PK, safety, and~     tolerability of GSK525762 when administered alone and when co-administered following repeat~     dosing of rifampicin, a known potent inducer of CYP3A4. In vitro inhibition data indicate~     CYP3A4 may be the major route of clearance for GSK525762 and co-administration of drug~     therapies which modulate CYP3A4 (i.e.CYP3A4 inhibitors and inducers) is likely to alter the~     exposure of GSK525762 (i.e. increase or decrease exposure, respectively). The data generated~     from this current study to justify exclusion criteria on concomitant medications which affect~     CYP3A4 or Pgp and also inform potential dose modification in case of co-administration with~     medication affecting CYP3A4 activity. All subjects will undergo a screening visit within 28~     days of the first dose of study drug followed by one treatment period and a follow-up visit~     7-10 days after the last dose of GSK525762. Subjects in Part 1 will participate in the study~     for up to 45 days and subjects in Part 2 will participate for up to 56 days.~   "
65740|NCT02706522|"~     This study is to evaluate the effects of preoperative carbohydrate intake on perioperative~     neuroinflammation and development of delirium.~   "
65741|NCT02706509|"~     A multicenter prospective interventional comparative study that investigate pain management~     during Jaydess insertion in nulliparous women that will be tested by the analgesic affects of~     oral tramadol or 'verbal anesthesia' on the patients.~   "
65742|NCT02706496|"~     With aging, the elderly decreased ability to control postural balance will be accompanied by~     increased risk of falling (Berg et al, 1992;. Tinetti et al, 1988). According to previous~     studies, it showed that the elderly over 65 years fall each year probability was 30 %, and it~     increased with age (Skelton, & Todd, 2004). In view of this, age-related posture control has~     become important issues of modern preventive medicine and family care.~   "
65743|NCT02706483|"~     Multi-center, open-label, long-term safety study~   "
65744|NCT02706470|"~     The purpose of this study is to determine whether Cyclosporin A (CsA) - an immunosuppressant~     drug - in early pregnancy will reduce the risk of miscarriage in women who had a history of~     unexplained recurrent miscarriages, as compared with that treated with Dydrogesterone-an~     active comparator. The hypothesis is based on the evidence found in vitro and in vivo~     experiments that CsA can induce maternal-fetal tolerance so that it may reduce the risk of~     miscarriage.~   "
65745|NCT02706457|"~     Barthel Index and demographic variables of patients were collected to investigate the~     question whether the improvements of the functionality improves the Barthel Index over the~     years.~   "
65746|NCT02706444|"~     To evaluate the role of DCB angioplasty for venous anastomotic stenosis of hemodialysis~     graft, investigators would like to perform randomized study comparing the results of drug-~     coated balloon angioplasty with conventional balloon angioplasty in the treatment in venous~     anastomotic stenosis of AVG in terms of patency.~   "
65747|NCT02706431|"~     Oxygenation with high-flow nasal cannula with 100% oxygen has only been evaluated in a~     limited number of studies. Although data are convincing it is of importance to evaluate this~     new concept in our department before implementing it into clinical practice.~      The general purpose of this project is to evaluate a new ventilation strategy during~     ENT-surgery based on oxygenation with high-flow nasal cannula with 100% oxygen with focus on~     gas exchange.~   "
65748|NCT02706418|"~     Once participants have been recruited, their grip strength shall be tested and they will all~     complete baseline questionnaires to assess functional status and symptom severity.~      Following the recruitment stage, participants will be asked to attend Medway Maritime~     Hospital once a week for four weeks, to receive the massage protocol. At the first session~     participants shall be asked to rate their pain (NPRS), before receiving a massage treatment.~     This will be followed by instructions on how to perform self-massage, which they will be~     asked to complete daily over the four-week period, and record in a diary. At the remaining~     three sessions, participants shall just complete the NPRS prior to receiving the massage~     treatment.~      After four weeks the group will be reassessed at the same Orthopaedic Clinic they attended~     prior to recruitment. They will be asked to complete a final pain score, record any changes~     in their condition, repeat the initial symptom questionnaire, and finally preform a grip~     strength test. The duration of four weeks was chosen as this is the time-frame within which~     the specific massage protocol advises a 'significant symptom improvement' should be seen.~   "
65749|NCT02706405|"~     This phase Ib trial studies whether anti-CD19-chimeric antigen receptor (CAR) lentiviral~     vector-transduced autologous T cells (JCAR014) and durvalumab are safe in combination and can~     work together in treating patients with non-Hodgkin lymphoma that has returned after a period~     of improvement or has not responded to previous treatment. JCAR014 is made of patients'~     immune cells (T cells) that have a new gene added to them in a laboratory, which programs~     them to kill lymphoma cells. Durvalumab is a type of drug called a monoclonal antibody,~     targeted to PD-L1 that may help immune cells attack cancer cells more effectively and thus~     help JCAR014 work better.~   "
65750|NCT02706392|"~     This phase I trial studies the side effects and best dose of genetically modified T-cell~     therapy in treating patients with receptor tyrosine kinase-like orphan receptor 1 positive~     (ROR1+) chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), acute lymphoblastic~     leukemia (ALL), stage IV non-small cell lung cancer (NSCLC), or triple negative breast cancer~     (TNBC) that has spread to other places in the body and usually cannot be cured or controlled~     with treatment (advanced). Genetically modified therapies, such as ROR1 specific chimeric~     antigen receptor (CAR) T-cells, are taken from a patient's blood, modified in the laboratory~     so they specifically may kill cancer cells with a protein called ROR1 on their surfaces, and~     safely given back to the patient after conventional therapy. The genetically modified~     T-cells have genes added in the laboratory to make them recognize ROR1.~   "
65899|NCT02704442|"~     The hypothesis is that pediatric patients with increased levels of anxiety on the day of~     surgery, in particular at point of anesthetic induction, will demonstrate decreased~     compliance with assessment in ophthalmology clinic postoperatively.~   "
65751|NCT02706379|"~     Early goal directed therapy (EGDT) is an effective treatment for patients with septic shock,~     which is widely used in clinic. Fluid resuscitation can significantly reduce the mortality of~     patients with septic shock and improve the prognosis of patients with EGDT. However, in~     recent years, the standard of EGDT to determine the existence of the target of septic shock.~     Some studies have shown that there may be a manifestation of the deficiency of kidney and~     liver and other organs such as kidney, liver and other organs in the recovery of EGDT.~     Therefore, this experiment is to explore the brain perfusion and metabolism of the EGDT when~     the target is reached.The aim of this study was to investigate the effects of EGDT as a guide~     to the cerebral perfusion and metabolism in order to provide clinical evidence for the~     treatment of fluid resuscitation in patients with septic shock.~   "
65752|NCT02706353|"~     You are being asked to take part in this study because you have metastatic (cancer that has~     spread) melanoma.~      The goal of Part 1 of this clinical research study is to find the highest tolerable dose of~     APX005M that can be given with pembrolizumab that can be given to patients with metastatic~     melanoma.~      The goal of Part 2 of this study is to learn if the combination can help to control~     metastatic melanoma.~      The safety of this drug combination will also be studied.~      This is an investigational study. APX005M is not FDA approved or commercially available. It~     is currently being used for research purposes only. Pembrolizumab is FDA approved and~     commercially available for the treatment of metastatic melanoma. The combination of these~     drugs to treat metastatic melanoma is investigational.~      The study doctor can explain how the study drug is designed to work.~      Up to 41 participants will be treated in this study. All will take part at MD Anderson.~   "
65753|NCT02706340|"~     This is an observational study enrolling women who have had a copper intrauterine device~     placed immediately after childbirth. The study follows participants for 6 month in order to~     evaluate the primary outcome of IUD expulsion within 6 months of delivery.~   "
65754|NCT02706327|"~     The purpose of this study is to compare computer aided design/computer aided manufacturing~     (CAD/CAM) and semi-custom insole types on pain, quality of life and physical performance and~     also to decide whether they are necessary in treatment of painful flexible flatfoot.~   "
65755|NCT02706314|"~     Critical illness in the ICU setting has high medical and socioeconomic importance. Critically~     ill patients frequently develop severe neurologic impairment during their course of disease,~     typically presenting as critical-illness-polyneuropathy (CIP), which is associated with an~     increased mortality rate. To date neither strategies are available to predict nor to~     specifically treat CIP.~      Diagnostic tests to determine CIP during the course of critical illness are available through~     nerve conduction studies. Further research is needed to find diagnostic tools to identify~     patients who are on high risk to develop CIP, which could encourage the evolution of new~     therapeutic strategies for CIP patients.~      The aims of the study are:~        1. An early detection of changes in intramural neuronal networks of human colon samples~          induced by human blood serum from critically ill patients in order to predict the~          development of CIP~        2. The comparison of different diagnostic tests to diagnose and monitor CIP during the~          course of critical illness (neurologic examination versus nerve conduction study versus~          neuromyosonography)~   "
65756|NCT02706301|"~     Colorectal cancer survivors experience long-term negative physical and psychosocial~     consequences of their disease. There is a critical need to develop novel behavioral~     interventions for improving colorectal cancer survivor outcomes. The investigators have~     developed a pain management intervention for colorectal cancer survivors that focuses on~     addressing both pain and psychological distress. Colorectal cancer survivors who endorse pain~     and comorbid psychological distress as a concern during a clinic-based survivorship care~     consult will be recruited. Participants will be randomized into either: Telephone-Based~     Coping Skills Training (CST) for pain and comorbid psychological distress or standard care.~     The CST condition will receive 5 sessions of a cognitive behavior theory-based protocol that~     teaches coping skills (e.g., relaxation, activity pacing/planning, cognitive restructuring)~     relevant to managing pain and psychological distress. The standard care control condition~     will receive resources and referrals related to managing survivorship health.~   "
65757|NCT02706288|"~     The purpose of this study is to understand how weight loss by a very low fat plant-based diet~     with an exercise program affects metabolic and cardiovascular health in overweight adults at~     high risk for disease. Outcome measures will include assessment of insulin sensitivity,~     β-cell function, body fat distribution, skeletal muscle and adipose tissue biology,~     cardiovascular function, cardiorespiratory fitness, muscular strength, immune function, and~     the gut microbiome.~   "
65758|NCT02706275|"~     The purpose of this study is to determine whether externally warming critically ill afebrile~     adult septic patients will improve indices of immune function and/or clinical outcomes.~   "
65759|NCT02706262|"~     The purpose of this research study is to 1) understand how some, but not all people with~     obesity develop obesity related conditions such as type 2 diabetes and cardiovascular~     disease, and 2) compare the effects of 3 popular weight loss diets (Mediterranean,~     low-carbohydrate, or a very-low-fat plant-based diet) in people with obesity.~   "
65760|NCT02706249|"~     Hospitalized patients with histologically or cytologically confirmed diagnosis of solid tumor~     malignancy, lymphoma, or multiple myeloma and who are at high risk for a venous~     thromboembolism will be randomized to standard dose versus intermediate dose enoxaparin.~   "
65761|NCT02706236|"~     The study purpose is to characterize the effect of pancreatic enzyme supplementation on~     chronic pancreatitis type pain.~   "
65791|NCT02705846|"~     GENPROS aims to analyse the outcomes of patients with rare gene mutations in the cancer~     predisposition genes, BRCA1, BRCA2, HOXB13, and Lynch Syndrome, after a diagnosis of and~     treatment for prostate cancer (PCa). The study includes a cohort of gene mutation carriers~     with PCa matched with a control group of men with PCa who are known not to carry a mutation~     in the same gene. Clinical data regarding treatment and patient outcome will be collected~     retrospectively and prospectively. Archived tumour samples will also be collected for tumour~     profiling. A blood or saliva sample will be taken, if the participant consents to this part~     of the study, for genetic profiling to investigate any association of other inherited factors~     with PCa outcomes. Information obtained from this study will be of critical importance to~     support clinical trials investigating the most appropriate management of PCa in this group of~     patients at increased risk of prostate cancer.~   "
65762|NCT02706223|"~     Hepatitis C Virus, (HCV), infection is a major health concern in the UK with up to 0.7% of~     the population infected. At best, 25% of those infected will clear the infection~     spontaneously, though for those who develop a chronic infection, they may go onto to develop~     liver cirrhosis or liver cancers.~      The standard of care within the NHS is that patients with a history of intravenous drug use~     or those currently on methadone are at high risk of having HCV infection and should be~     offered HCV testing. Once diagnosed they can be referred to nurse led treatment pathways.~     Less than 10% of the methadone users are even tested for HCV and of them fewer than 20% go~     onto treatment regimens that successfully clear the infection despite regular interactions~     with heath care staff.~      Pharmacists who have daily interactions with patients receiving methadone are ideally placed~     to deliver anti HCV therapy as they have daily contact with this client group and are well~     placed to advise on the drug therapy.~      The SuperDOT C study will examine the impact of pharmacy led Directly Observed Therapy (DOT)~     for HCV treatment in patients attending Community Pharmacies in participating Health Boards~     within NHS Scotland. The impact of this approach will be compared with those referred to~     standard care pathways on how well participants clear their HCV infection.~   "
65763|NCT02706210|"~     Dementia is one of the main chronic non-communicable diseases associated with disability,~     institutionalization, and mortality among elderly individuals. Alzheimer's disease (AD) and~     vascular dementia (VD) are considered to be the main types of dementia. A widely shared view~     is that future treatment strategies need to focus on treatment of the earliest stages of the~     disease. Mild cognitive impairment (MCI) constitutes an intermediate stage between normal~     aging and dementia. Vascular cognitive disorders (VCD) is an umbrella term representing a~     wide spectrum of cognitive disorder evoked by or associated with vascular causes. It~     encompasses patients suffering from a range of types of cognitive impairment, from mild~     impairment to VD. VCD predementia (VCD-P) is at the same stage of MCI. Amnestic MCI (aMCI) is~     a subtype of MCI, which is also considered to be the clinical transition stage between normal~     aging and AD, and has been applied to detect the emerging dementia. In VCD, infarcts or~     profuse white matter disease are considered the cause of cognitive decline. By contrast, AD~     is one of the most common progressive neurodegenerative disorders thought to be caused by~     amyloid aggregation and the formation of tau tangles. Both VCD-P and aMCI have a deficit in~     cognitive domains, and may have the same chief complaints of memory deficit. If it can be~     clear which will turn into what type of dementia in patients with cognitive impairment stage,~     it can not only make us more early intervention treatment to the patients, but also can save~     a lot of social resources and economic costs in clinic. By applying the resting state~     functional magnetic resonance (fMRI), structural magnetic resonance imaging (sMRI) and~     diffusion tensor magnetic resonance imaging (DTI) multimodal magnetic resonance (NMR)~     technology, the project comprehensive analysis comparison of neurodegenerative and blood~     vessels of brain function in patients with mild cognitive impairment and structural~     abnormalities connection mode. This project in order to reveal the cognitive impairment~     disease neural circuits in the development of the network connection and its change rule.~     People can further understand the pathogenesis of cognitive impairment, discover new will~     provide a scientific basis for prevention, diagnosis and treatment.~   "
65764|NCT02706197|"~     Tumors with low oxygen levels are associated with poor prognosis and resistance to standard~     radiotherapy or systemic therapies. The ability to make repeated oxygen measurements in~     tumors could be used to help select the most effective treatment or the best timing to start~     therapies. The purpose of this study is to ascertain the safety and feasibility of using an~     implantable oxygen sensor, known as the OxyChip, to make oxygen measurements in tumors using~     EPR oximetry, a technique related to magnetic resonance imaging (MRI).~   "
65765|NCT02706184|"~     In patients with gastric or colorectal cancers, where a treatment with 5-Fluoruracil in~     combination with other chemotherapeutic remedies (FLO, FOLFOX, FOLFOX-Bev, FOLFIRI) is~     planned, it shall be investigated whether E. coli Nissle suspension has an effect on duration~     and intensity of chemotherapy induced diarrhea.~   "
65766|NCT02706171|"~     This study is evaluating treatment with CyberKnife for soft tissue sarcomas.~   "
65767|NCT02706158|"~     Aims: Pre-eclampsia is one of the leading causes of maternal and perinatal morbidity and~     mortality worldwide. Preeclampsia frequency is 2-8% from all pregnancies. Dietary factors and~     dietary status have been suggested to play a role in development of preeclampsia. Low intake~     of nutrients such as calcium, vitamin D, magnesium, omega 3 fatty acids, is related to~     increased risk of preeclampsia. Also high triglyceride levels, high BMI, low Omega 6: omega 3~     ratio and high calories consumption are possible risk factors.~      Material and Methods: A prospective study will be carried out. Woman medically diagnosed as~     high risk for preeclampsia will randomly be assigned to dietary treatment or no dietary~     treatment groups. In the dietary treatment group, besides medical care, all woman will get~     calcium and vitamin D supplementation from 8th to 16th gestational weeks, and thereafter~     until delivery personal extensive nutritional guidance. A 3 day food diary will be collected~     at inclusion and thereafter at Gestational weeks 16 and 28. All routinely collected data~     during pregnancy (blood tests, weight, blood pressure and preeclampsia symptoms) will be~     documented.~      In both groups incidence of pre-eclampsia and eclampsia, blood pressure and protein in urine~     will be recorded.~   "
65768|NCT02706145|"~     The project will utilize a quasi-experimental design to examine the effectiveness of a~     community-level, three-year social norming campaign aimed at changing norms of violence among~     youth 10-24, with West Louisville (WL) as the intervention community and East Nashville,~     Tennessee as the control community. The project will address the following research questions~     (RQs):~      RQ1: To what extent is a social norming campaign effective in changing the descriptive and~     injunctive norms of violence among youth in WL?~      RQ2: To what extent are the descriptive and injunctive norms of violence among youth in WL~     related to violent behavior (by type)?~      RQ3: To what extent is a social norming campaign effective in reducing population rates of~     youth violence in WL?~      RQ4: Which forms of media are most effective in reaching youth of different ages with~     campaign messages?~      RQ5: How is community readiness related to implementation of a community-level social norming~     campaign?~      RQ6: How is community capacity related to implementation of a community-level social norming~     campaign?~      RQ7: How does community capacity to address youth violence change over time with the~     implementation of a community-level social norming campaign?~      RQ8: To what extent is a social norming campaign cost-effective in reducing incidents of~     serious violence among youth?~   "
65769|NCT02706132|"~     The purpose of this study is to determine whether MSCs are safe and effective in reducing the~     primary nonfunction (PNF), acute rejection and Ischemic-type Biliary Lesions (ITBLs)~     morbidity in ABO-incompatible Liver Transplantation.~   "
65770|NCT02706119|"~     Analyze the level of metabolic control achieved with a routine of regular insulin in the~     parenteral nutrition (PN) reservoir in addition to subcutaneous glargine insulin, versus only~     regular insulin in the PN reservoir.~   "
65792|NCT02705833|"~     The primary objective of the study is to characterize the medical management of squamous cell~     carcinoma head and neck (SCCHN) patients diagnosed with recurrent/metastatic (R/M) disease~     (between 01July2013 and 30 June 2014) in the real-world setting.~   "
65771|NCT02706106|"~     It is a controlled clinical trial randomized, double-blind evaluator. Will be considered~     eligible patients, individuals of both sexes, aged 40 -60, to submit at least four items of~     knee osteoarthrosis classification criteria, according to the American College of~     Rheumatology, pain above four points in the visual analogue scale (VAS), diagnosed with knee~     osteoarthritis and who sought physical therapy treatment.~      Patients will be randomized by a number sequence generated by a computer using Microsoft~     Excel (Microsoft Corporation, Redmond, Washington), in opaque envelopes by researcher who~     will not attend the study.Patients will be divided into two groups: group with knee patellar~     hole or group without knee patellar hole. Shortly after the selection of the knee, the~     patient will have his eyes blind or cover in order to keep it '' blind '' regarding the type~     of knee brace that it would use.~      Finally evaluator 1 will cover the knee with a black cloak, making the second evaluator~     ''blind '' regarding the type of knee brace that will be used.~      Two investigators will carry out the data collection. The first evaluator will collect~     information on the clinical characteristics of patients, including evaluation form, numerical~     pain scale, which measures the intensity of pain, test Time Up and Go (TUG) test that~     measures the basic mobility of movement and test walking eight meters, whose purpose is to~     measure the time that the individual takes to walk a distance of eight meters.~   "
65772|NCT02706093|"~     The overall objectives are to:~        1. Assess mechanisms underlying HIIT-induced improvements in insulin resistance at the~          whole-body, tissue, and cellular levels.~        2. Systematically compare different HIIT regimens to help identify effective doses of~          HIIT that may be optimal for improving metabolic health in obese adults.~        3. Assess the ability/willingness of obese subjects to adhere to a long-term HIIT program.~      Findings from these studies will greatly expand knowledge about the effects of HIIT on~     metabolic health, and will provide valuable information for development of programs aimed at~     maximizing key metabolic benefits of exercise.~   "
65773|NCT02706080|"~     Antithrombotics with antiplatelet agents, vitamin K antagonist (VKA), heparin and related~     substances, and new oral anticoagulants are prescribed for arterial diseases, especially in~     secondary prevention of embolic disease in carrier patients of heart valves and in patients~     with fibrillation atrial, and venous diseases, in prevention and treatment.~      The prescription of these treatments is increasing especially in older patients associated~     with many comorbidities. Today, an estimated number of 900 000 patients under anti-vitamin K~     in France, and more than 1.5 million for patients on antiplatelet agents.~      Venous thromboembolism (VTE) is common in the general population with an annual incidence of~     10-18 cases per 10 000. The most severe form of VTE is represented by pulmonary embolism with~     a third of cases. Even if a large literature allows for high grade recommendations on many~     areas, there is still some gray areas regarding the long-term outcomes, the early evolution~     and tolerance of treatment, including long-term recurrence, the incidence of embolic sequelae~     with post-embolic pulmonary hypertension and association with other cardiovascular arterial~     accident (acute Coronary Syndrome, Stroke, arterial disease of the Lower Extremities ...).~      The major risk of these antithrombotic is bleeding both in terms of morbidity mortality.~     Despite this risk, little study focuses on the exact epidemiology of bleeding associated with~     the use of antithrombotic. If the frequency of hemorrhagic stroke is low, some populations~     particularly at risk of bleeding represent the majority of serious bleeding events under VKA~     or anti-platelet. However, the VKA and antiplatelet agents are the first providers of~     hemorrhagic serious side effects drugs when looking at all national and international studies~     on the iatrogenic with in topped gastrointestinal bleeding and intracerebral hemorrhage~     (mortality of about 10 to 15%).~      Moreover the recent arrival of new oral anticoagulants (Apixaban rivaroxaban, dabigatran ...)~     should profoundly change the management of venous thromboembolism and cardioembolic event.~     Because of their risk-benefit, simplicity and convenience of their prescription, the number~     of patients treated with these new anticoagulants were to rise rapidly. In addition, many~     patients deemed too fragile to be treated with VKA, should be treated with these~     treatments. These new anti-Xa and anti-IIa anticoagulants already marketed or about to be.~     They have the advantage over VKA: an oral way, their pharmacokinetic characteristics, absence~     of biological monitoring, chemical synthesis .... If it is not possible today to give the~     advantage to one or the other of these molecules, the choice will be directed by their~     pharmacokinetic characteristics, their half life, their method of disposal but also by~     patients co-morbidities. Although biological tests are currently available for the monitoring~     of these products, therapeutic solutions for severe bleeding does not exist: there is indeed~     no antidote for now, though the issue is finding a balance between increased therapeutic~     benefit and bleeding risk optimization. But hemorrhagic stroke is the most serious~     complications of oral anticoagulant therapy, with substantial documentation for these events~     occurring under VKA but little data on those occurring with the new oral anticoagulants~     (Apixaban rivaroxaban, dabigatran ...).~   "
65774|NCT02706067|"~     This study will evaluate the efficacy of a multifactorial approach associated with orlistat~     (Xenical) in weight loss maintenance during 4 years. The effect of orlistat in combination~     with diet, physical activity, and/or cognitive behavioral therapy will be monitored.~   "
65775|NCT02706054|"~     This randomized, double-blind, placebo control, cross-over study tested the hypothesis that~     periradicular injections of Meloxicam would reduce recent onset low back pain and improve~     physical activity compared to saline injection at 3 months follow-up evaluation~   "
65776|NCT02706041|"~     Randomized study to compare outcomes of patients undergoing damage control laparotomies~     versus definitive closure for which there is surgeon equipoise to randomize.~   "
65777|NCT02706028|"~     In this randomized, double-blind, placebo-controlled study the effects of underwater~     ultrasound (US) therapy were investigated in 48 patients with moderately active rheumatoid~     arthritis (disease activity score in 28 joints (DAS28) ≥3.2 and ≤5.1).~      Patients randomly assigned to the ultrasound group (N=25) received underwater ultrasound~     therapy to both wrists and hands for 7 minutes per session with an intensity of 0.7 W/cm2~     during 10 sessions. The control group (N=23) received sham treatment under the same~     conditions. At baseline, at the end of treatment (Week 2) and at the follow-up visit (Week~     14), the following parameters were evaluated: disease activity - erythrocyte sedimentation~     rate (ESR), C-reactive protein (CRP), tender and swollen joint counts, pain on a visual~     analogue scale, and DAS28, hand function (fist making, wrist extension and flexion, hand grip~     strength), quality of life - Health Assessment Questionnaire (HAQ), and the patients rated~     their own condition.~   "
65778|NCT02706015|"~     This study evaluates the non-inferiority of Cefaliv® compared to Neosaldina® in the treatment~     of migraine attack in two hundred and sixteen adults of both sexes with age between eighteen~     and sixty five years old. The first Half of participants will receive Cefaliv®, the other~     half will receive Neosaldina®.~   "
65779|NCT02706002|"~     Fluoroscopy is routinely used in trauma cases to evaluate alignment and reduction quality.~     Because conventional templating has a high mismatch rate, the investigators sought to explore~     whether the investigators could use intraoperative fluoroscopy while implanting the femoral~     stem.~   "
65780|NCT02705989|"~     The purpose of this study is to evaluate the safety profile, tolerability, pharmacokinetics,~     and pharmacodynamics following single and multiple ascending oral doses of BMS-986195 in~     healthy subjects, and to assess the relative bioavailability of two formulations of~     BMS-986195 with or without food.~   "
65781|NCT02705976|"~     The aim of this study is to perform a randomized trial comparing the use of the algorithm,~     with dosing of warfarin in standard manual dosage clinical practice, in a high quality~     anticoagulant setting (PSM). This is done for safety concerns and to ensure good performance~     of the algorithm when used in a clinical setup. The results from the study are expected to~     increase our knowledge of efficacy by using the algorithm in clinical practice.~   "
65782|NCT02705963|"~     The purpose of this study is to evaluate the effect of trametinib once daily on the~     pharmacokinetics (PK) of a daily dosing oral contraceptives (OCs) containing norethindrone~     (NE) and ethinyl estradiol (EE) in female patients with solid tumors. The PK of trametinib~     and its metabolite M5 will also be assessed.~   "
65783|NCT02705950|"~     Hypothesis:~      ITB bolus can have antinociceptive effect on neuropathic pain in spinal cord injury patients,~     which could depend on the subtype of pain, or on the lesion level, cervical or thoracic~     spinal cord injury.~      Objective:~      To study the effect of intrathecal baclofen bolus on neuropathic pain in patients with spinal~     cord injury at cervico-dorsal level.~      Primary Endpoint:~      Effect of intrathecal baclofen bolus in neuropathic pain (measured using the Neuropathic Pain~     Inventory Scale, the Brief Pain Inventory and the Numerical Rating Scale) in spinal cord~     injury at cervico-dorsal level.~      Secondary Endpoints:~        1. Spasticity and spasms (measured using the Modified Ashworth Scale and the Visual~          Analogue Scale and Penn Spasm Frequency Scale).~        2. Neurophysiological examination (warm perception threshold, heat pain perception~          threshold, evoked pain perception and contact heat evoked potentials).~   "
65793|NCT02705820|"~     Single arm one stage Phase II study: post 4-6 cycles platinum doublet chemotherapy for~     patients with metastatic Non Small Cell Lung Cancer (NSCLC) offering Pembrolizumab as~     maintenance therapy to non-progressors with primary endpoint: Immune Related Progression Free~     Survival (irPFS) at 1 year. Aim to show that this is at least 25% (compared to an expected~     12% 1 year PFS based on the Pemetrexed and Erlotinib maintenance trials).~   "
65784|NCT02705937|"~     Dry mouth symptoms mostly occur as drug side-effects. Available products such as saliva~     substitutes are disappointing (bad taste, poor efficiency).~      The hypothesis stems from the empirical observations that many patients alleviate dry mouth~     symptoms by the consumption of dairy products. Through its composition, the dairy product in~     itself provides relief for the patient, due both to its physical and biochemical properties,~     which could explain these observed improvements, and to elements related to the phenomena of~     consumption of food as an alternative to medication. In the latter case, hedonism takes on a~     role which has not been previously assessed. Initial work undertaken with the department of~     applied research at the National Dairy Industry School (ENIL) led to the prototyping of a new~     milk product, to qualify and adapt a product with a health benefit in patients suffering~     from xerostomia.~      This dairy product has specific taste, texture and lubrication properties and will be tested~     in a randomized controlled cross-over study for its efficiency and acceptability versus a~     reference product (Aequasyal ®, Oxidized Glycerol Triester) on a group of 32 patients at~     Dijon and at Besançon University Hospitals.~      This way of combatting xerostomia at the interface of patients' diet, such as it is proposed~     here, could help improve their quality of life, minimize harmful effects (infection, decay)~     and promote adherence to treatments which are responsible for xerostomia.~   "
65785|NCT02705924|"~     Young female counselees (18-30 years) belonging to HBOC families with a known mutation on~     BRCA-genes or not, receive a lot of information regarding their cancer risk. Information~     sources are numerous and sometimes contradictory. Unfortunately, these women face these~     issues at a key moment of there identity construction (self, relationship, sexuality) while~     they are not yet concerned by health prevention measures. A special psychoeducational~     intervention was designed to help these women to better cope with these difficulties.~      Intervention consists in a week-end session in a thermal center (SPA) during which they will~     attend short conferences given by specialists (prevention measures, prophylactic surgery,~     assisted procreation, epidemiology...) and participate to role games and group sharing.~      Intervention will be evaluated using self-questionnaires completed before intervention and~     during the following year.~   "
65786|NCT02705911|"~     The purpose of this RCT which will be performed in 60 healthy adults is I. To assess the~     training effects of 8 weeks of isometric handgrip exercise on BP; and to test whether it~     yields at least similar effects on BP compared to current exercise recommendations.~      II. To assess whether isometric handgrip training yields larger BP reductions beyond the~     supervised training period at 6 months of follow-up.~      III. To determine whether changes in BP following acute exercise and chronic training can be~     explained by changes in important physiological mechanisms known to mediate or to be~     associated with BP?~   "
65787|NCT02705898|"~     Building on the large body of evidence for the effect of exercise in decreasing depressive~     symptoms and the few preliminary findings of its effect on craving and drinking outcomes, the~     purpose of this study is to develop a lifestyle physical activity (LPA) intervention that~     harnesses the technological advantages of the Fitbit tracker (plus its web and mobile~     platforms) for depressed women with alcohol use disorders (AUDs). The intervention will~     provide women with an acceptable, flexible and effective alternate coping strategy during~     early recovery, when relapse risk is highest. The overall objective of this work is to fully~     develop this LPA+Fitbit intervention, modify it based on initial piloting and feedback to~     ensure its feasibility and acceptability for depressed women with AUDs in early recovery,~     propose potential mechanisms of its effect, and to obtain preliminary data on its efficacy.~   "
65788|NCT02705885|"~     Patients visiting National Hospital of Odonto-Stomatology for treating periodontitis used a~     food supplement (lozenge) containing chicken egg antibody (IgY) against Porphyromonas~     gingivalis gingipains as an adjunct to conventional scaling and root planing (SRP). After 8~     weeks the patients were examined against. Parameters including probing depth (PD), bleeding~     on probing (BOP), number of P. gingivalis in periodontal pockets were evaluated and compared~     to the control group that had used placebo lozenges.~   "
65789|NCT02705872|"~     The epidural has been recognized for many years as the most effective analgesia method for~     obstetrical labor. Several different administration protocols have been evaluated over the~     years with the aim of reducing side effects.~      Epidurals have been incriminated in the increase of instrumented births. It is indeed~     possible that the motor block induced by the epidural reduces the pelvic tonus and the~     ability of the mother to push during the second stage of the labor. Furthermore, this motor~     block might lead to a ill rotation of the foetal head within the pelvis, which could lead to~     instrumentation (suction cups, forceps).~      In the investigator's institution, an ongoing study also provided interim that showed that~     the use of a low concentration of local anesthetics (as opposed to a higher concentration)~     tends to decrease the instrumentation and cesarean sections rate in the institution's~     population.However, the optimal administration mode of the local anesthetic in the epidural~     remains unknown.~      In the last few years, there has been a growing interest for a new method of administration~     of the solution within the epidural, by programmed intermittent bolus. This method allows a~     better distribution of the local anesthetics in the epidural space, compared to a continuous~     perfusion.~      This study therefore focuses on the relationship between the use of epidural with programmed~     intermittent boluses and the rate of instrumented deliveries and cesarean sections.~      The exact mode of administration of boluses is also subject to discussion in the literature.~     One can question whether it is preferable to administer smaller boluses more frequently or~     larger less frequent boluses. A few studies have investigated this issue and recommend to~     administer larger and more spaced bolus (10 mL to 60 minutes).This better matches the sought~     after physiology (ie a wider distribution in the epidural space) and provides equivalent~     analgesia to smaller, more frequent boluses.~   "
65790|NCT02705859|"~     This study is a Phase Ib/II open label, single arm, adaptive multi-centre trial of copanlisib~     in combination with trastuzumab in pretreated recurrent or metastatic HER2-positive breast~     cancer.~      Patients with HER2 positive, metastatic or incurable recurrent breast cancer, following~     disease progression during, or after, treatment with at least one systemic treatment regimen~     in the metastatic or recurrent setting, will be treated with copanlisib (at 30, 45 or 60 mg~     flat dosing IV weekly - depending on the maximum tolerated dose (MTD) determined in the Phase~     Ib part of the study) plus trastuzumab (4 mg/kg IV Cycle 1 Day 1 and then 2 mg/kg IV weekly~     starting from day 8).~   "
65805|NCT02705664|"~     The main objective of this study is to compare subject adherence and satisfaction for two~     modes of treatment toenails infection (Onychomycosis) with Loceryl Nail Lacquer (Loceryl NL)~     and a Fungal Nail Treatment Set containing Urea 40% ointment (Urea) and Bifonazole cream 1%~     (Bifonazole).~   "
65900|NCT02704429|"~     Open-label cohort study in adult patients with newly diagnosed or relapsing pemphigus~     vulgaris, with intra-patient dose-adjustment based on clinical response and BTK occupancy,~     and with conventional immunosuppressive rescue treatment, if indicated. The duration of~     therapy will be 12 weeks, followed by 12 weeks of follow up.~   "
65901|NCT02704416|"~     This trial aims to develop evidence based curative treatment with optimal net benefit for~     patients with Brugada syndrome.~   "
65794|NCT02705807|"~     This study is a Phase IV, open-label, single-arm study to assess the safety and the necessity~     of dose adjustment after switching to FLOLAN injection prepared with the reformulated diluent~     in Japanese patients with PAH who are receiving higher doses of FLOLAN injection than in~     other countries. The objective is to evaluate the safety and tolerability of the thermostable~     formulation of FLOLAN injection (that is [i.e.], FLOLAN injection prepared with the~     reformulated diluent) when switched from the existing FLOLAN injection treatment (i.e.,~     FLOLAN injection prepared with the currently marketed diluent). The study will include a~     screening visit, a run-in period of a maximum of 4 weeks with the existing FLOLAN treatment~     (i.e., FLOLAN injection prepared with the currently marketed diluent), a 4-week treatment~     period with the thermostable formulation of FLOLAN injection (i.e., FLOLAN injection prepared~     with the reformulated diluent) and a one-week follow-up visit. Adequate number of subjects~     will be enrolled in the study in order to have 10 subjects to complete assessments at 4~     weeks, including at least 5 subjects as a subset of subjects who consent to undergo right~     heart catheterisation (RHC) over 24-hour and at Week 4. FLOLAN is a registered trademark of~     the GlaxoSmithKline [GSK] group of companies.~   "
65795|NCT02705794|"~     The study title Clinical trial of comparative evaluation of the Modified Mallampati Score~     and Modified Mallampati Score along with Thyromental distance, Anatomical abnormality, and~     Cervical mobility (M-TAC) in Predicting Difficult Airway  was undertaken to evaluate~     prediction of difficult airway by comparing preoperative airway evaluation tests.~      Mallampati classification is the most used screening test for detection of difficult~     intubation it is a classification of oropharyngeal view. Other tests include sternomental~     distance, thyromental distance, Wilson risk sum score, upper lip bite test, protrusion of~     mandible, tooth morphology, head extension, mouth opening, body mass index, 3-3-2 rule and~     ultrasonography of neck soft tissue. We studied 200 adult ASA I & II patients of either sex,~     aged between 18-60 yrs undergoing elective surgery receiving general anesthesia.~      Modified mallampati classification had four grades & each grade was given a score, similarly~     thyromental distance (TMD), anatomical abnormality (AA) & cervical mobility (CM) was~     classified into three grades & each grade was given a score. For M-TAC individual scores were~     added.~   "
65796|NCT02705781|"~     This study conducted in order to validate the functionality and accuracy of the smARTrack™~     System in a real-life ICU setting. The smARTrack™ Feeding Tube System is a novel system with~     nasogastric tube developed by ART Healthcare Ltd, based on sensor-lined tubes that transmit~     real-time information to an external console. The smARTrack™ feeding tube is equipped with~     reflux sensors which alert when gastric contents regurgitating into the esophagus. In~     addition, the smARTrack™ feeding tube is equipped with sensors designed to provide~     information about the location of the tube thus assisting in reducing the incident of~     misplacement during first positioning. The smARTrack™ feeding tube is also automatically and~     in real-time stops feeding if the feeding tube moves out of position during ongoing use or~     detect gastric content in esophagus. Furthermore, smARTrack™ Feeding Tube System can guide~     operator to correctly re-position the tube.~   "
65797|NCT02705768|"~     The present study has been planned to assess the level of serum neuron-specific enolase (NSE)~     in focal seizures and its changes after antiepileptic therapy.~   "
65798|NCT02705755|"~     This multiple-center, 3-part, single-blind dose escalation (Part A), randomized, double-blind~     (Part B), and open-label multiple dose extension (Part C) study will be conducted in male and~     female subjects with neurogenic orthostatic hypotension to evaluate the effect of TD-9855 in~     improving symptoms of orthostatic intolerance.~   "
65799|NCT02705742|"~     In this study, investigators aimed to transplant autologous, adipose tissue derived~     mesenchymal stem cells to the patients with liver cirrhosis due to HCV. We also aimed to~     assess liver tissue regeneration, downgrade of clinical findings and antiviral efficacy.~     Finally investigators aimed to establish an alternative treatment modality to liver~     transplantation.~   "
65800|NCT02705729|"~     The purpose of this study is to determine whether two tooth-colored glass ionomer materials~     are effective for load-bearing dental fillings.~   "
65801|NCT02705716|"~     This study will investigate the efficacy of an experimental dentifrice containing 0.454%~     weight/weight (w/w) stannous fluoride in relieving dentine hypersensitivity (DH) after twice~     daily brushing, over a 2 week treatment period compared with a standard fluoride dentifrice.~   "
65802|NCT02705703|"~     This study evaluates the effectiveness of Tumor Associated Peptide Antigens (TAPA) pulsed~     dendritic cell injections as a potential consolidation therapy for patients with metastatic~     solid malignancies (SM). The investigators hypothesize that treatment of patients with~     metastatic SM who demonstrate a tumor response, or whose disease remains stable, after~     conventional first-line systemic therapy AND who lack an available, potentially curative~     therapeutic intervention and whose tumor cells and/or blood express at least one (1) TAPA of~     a defined panel of TAPAs will result in TAPA-specific T-cell responses without significant~     toxicities. The investigators also hypothesize CD4+ and CD8+ T-cell responses generated~     against specific TAPAs may translate into clinical antitumor activity.~   "
65803|NCT02705690|"~     This study aims to benchmark the performance of an iOS application against the Berg Balance~     Scale (BBS), which is the most commonly used assessment tool by clinicians for measuring~     balance across the continuum from acute care to community-based care. An iPhone will be tied~     around the waist of the participant and concurrent measurements will be taken for five of the~     fourteen stances which comprise the BBS.~   "
65804|NCT02705677|"~     The overarching purpose of this study is to advance understanding of the natural history of~     Rett syndrome (RTT), MECP2-duplication disorder (MECP2 Dup), RTT-related disorders including~     CDKL5, FOXG1, and individuals with MECP2 mutations who do not have RTT. Although all these~     disorders are the result of specific genetic changes, there remains broad clinical variation~     that is not entirely accounted for by known biological factors. Additionally, clinical~     investigators currently do not have any biomarkers of disease status, clinical severity, or~     responsiveness to therapeutic intervention. To address these issues, biological materials~     (DNA, RNA, plasma, cell lines) will be collected from affected individuals and in some cases~     from unaffected family members, initial evaluation performed to identify additional~     biological factors contributing to disease severity, and these materials will be stored for~     future characterization.~   "
65905|NCT02704364|"~     The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in~     patients with Primary Sclerosing Cholangitis.~   "
65806|NCT02705651|"~     A.Background~      More than 90% of patients with multiple endocrine neoplasia type 1 (MEN1) develop multiple~     pancreatic neuroendocrine tumors (pNETs). These tumors are the most common cause for~     premature death in MEN1.~      While functioning pNETs must be treated to reduce or cure hormonal excess, the procedures for~     non-functioning pNETs are yet under discussion. Treatment ranges from watchful waiting to~     subtotal and total pancreatectomy. The latter may represent an overtreatment, resulting in~     general complications and diabetic metabolic status.~      The effect of somatostatin analogues (SAs) has shown promising results with regard to~     progression of non-functioning duodeno-pancreatic NETs. Treatment with SAs is highly safe and~     effective, resulting in long-time suppression of tumor growth.~      B. Aim~      In this study of MEN1 patients with non-functioning pNETs, the benefits of somatostatin~     analogs (SAs; group 1) compared to no treatment (group 2) will be analyzed with regard to~     progression (tumor growth; development of new [functioning and non-functioning]~     neuroendocrine tumors and regional/distant metastasis).~      C. Implementation~      Patients will either receive Somatostatin Analogs (SAs) or no treatment. The observation~     period will be 60 months. The increase of tumor size and development of new tumors or~     metastasis will be monitored.~   "
65807|NCT02705638|"~     Among persons with Immunoglobulin G subclass 4 Related Disease (IgG4)-related disease who~     have persistent or recurrent disease despite standard therapies, does combination therapy~     with rituximab and revlimid cause a sustained disease remission?~   "
65808|NCT02705625|"~     This is a multicentre, randomised, placebo-controlled, double-blind, three-arm parallel,~     Phase IIa study to evaluate the efficacy, safety and tolerability of MIV-711 in patients with~     knee osteoarthritis (OA).~   "
65809|NCT02705612|"~     The purpose of this phase II trial is to determine the feasibility and efficacy of~     nimotuzumab injection combined with concurrent chemoradiotherapy for initially inoperable~     locally advanced cervical cancer.~   "
65810|NCT02705599|"~     Predictors of the risk of recurrent stroke for patients with symptomatic intracranial~     atherosclerotic stenosis (ICAS) remain unknown. The study will be to explore the stroke~     mechanism evolution in patients with ICAS by multi-model magnetic resonance imaging (MRI)~     which consists of diffusion-weighted imaging (DWI) and high-resolution MRI (HRMRI). The~     patients with symptomatic ICAS will undergo multi-model MRI. The baseline data, infarct~     patterns on DWI, and plaque features on HRMRI will be collected. The stroke mechanisms will~     be determined by the infarct patterns. During the 2 years follow-up, the recurrent ischemic~     events will be recorded. By comparing the baseline data, infarct patterns, and plaque~     features in patients with and without recurrent strokes, the high-risk features of patients~     with symptomatic ICAS will be identified. The evaluation of stroke mechanisms of patients~     with symptomatic ICAS will be summarized.~   "
65811|NCT02705586|"~     To evaluate the feasibility of a video based mindfulness intervention for stress reduction~     and to evaluate the cortisol response in persons with PD and their caregivers. The data from~     this project will be used for a future grant application of a stress reduction intervention~     in persons with PD.~   "
65812|NCT02705573|"~     In this study we want to evaluate the effect of mannitol on postoperative renal biomarkers in~     patient receiving cadaveric renal transplantation. Furthermore we want to evaluate the effect~     of mannitol on perioperative redox status in patients receiving renal transplantation using~     the oxidation-reduction potentials assessed with the RedoxSYS®system.~      We are planning to perform a double-blind randomized controlled trial. In the study, mannitol~     20% with a dose of 1g / kg / BW (5 ml / kg / BW) will be compared to placebo with NaCl 0.9%~     in the dose of 5 ml / kg / BW. Patients will be randomized to receive either the mannitol or~     NaCl. The follow-up of the study is 24 hours. The following biomarkers will be determined~     befor induction of anesthesia and 24 hours after administration of study medication: CCL2,~     CHI3LI, GH, HGF, MMP1, MMP8, Tie2, TNF-R1, VCAM-1, KIM-1, Cystatin C, FGF23, IGFB7, NGAL and~     IL 18.~      Furthermore we want to perform sORP and cORP before induction of anesthesia, just before~     bolus of mannitol, 5 min after bolus of mannitol and after operation in anesthetic recovery~     room.~      Data will be collected, compared and published at the end of the study. It is planned to~     include a total of 34 patients in the study.~   "
65813|NCT02705560|"~     Dietary biomarkers are compounds in biofluids that directly reflect the intake of specific~     foods or food groups. Their exploration and use in the field of dietary assessments could~     provide an objective measure of actual intake complementing classical assessment methods~     (e.g. food frequency questionnaire, 24h recalls). To date, only a limited number of foods~     have been covered by validated biomarkers.~      The study is part of the international project The Food Biomarker Alliance (FOODBALL). The~     study described here has been assigned to assess biomarkers of the intake of milk and cheese.~     Up to now, there is an evident lack of data on specific and validated biomarkers of milk and~     cheese (dairy products), which belong to the most relevant public health related foods in~     Europe. This study will further provide novel insights into the influence of fermentation of~     milk-based foods on metabolic effects and postprandial adaptations, which has not yet been~     studied in depth before using cheese as fermented product. Outcomes will support and expand~     earlier findings on correlation between the intake of fermented dairy products intake and~     human health.~   "
65814|NCT02705547|"~     This study is an exploratory open-label clinical trial of Rosuvastatin in patients with~     Friedreich ataxia (FRDA). This is an outpatient trial with the goal of enrolling 10 evaluable~     adults with genetically confirmed FRDA who are between the ages of 18-65. Subjects will~     receive 10mg of oral Rosuvastatin daily for three months.~   "
65815|NCT02705534|"~     The investigators will treat 50 patients with cirrhosis due to hepatitis C genotype 1, with~     sofosbuvir 400 mg daily, ledipasvir 90 mg daily and weight-based ribavirin (1000 mg/d if <75~     kg, 1200 mg/d if >75 kg, divided in two daily doses) for 12 weeks and calculate the sustained~     viral response rate at 12 weeks.~   "
65851|NCT02705066|"~     The goal of this project is to determine the effects of 6-week dietary supplementation with~     one of two doses of citicoline (250 mg/d, 500 mg/d) or placebo on prefrontal cortical~     membrane dynamics (31P-MRS) and event-related functional activation (fMRI) in healthy~     middle-aged adults.~   "
65852|NCT02705053|"~     This clinical trial is a study to assess the performance of an automated glucose control~     system (Artificial Pancreas, AP) device in home settings for subjects with type 1 diabetes.~     Specifically, the investigators will test zone model predictive control AP that will be~     enhanced by run-to-run optimizations of basal rates (BR) and insulin to carbohydrate ratios~     (CR).~   "
65816|NCT02705521|"~     This randomised prospective controlled trial will investigate patients with impingement~     syndrome who undergo arthroscopic subacromial decompression. The intervention group will~     receive physiotherapy aided by automated sensor-based technology which will help them perform~     exergames and track their rehabilitation progress. The control group will be treated by~     standard physiotherapy protocols. The two groups will be compared using patient reported~     outcome measures and assessment of shoulder range of movement before and after the shoulder~     surgery.~      Data will be collected on patient experience, engagement with the rehabilitation process and~     the usability of the sensor-based technology through the use exergames. This will guide~     development of methods to quantify patient activation and engagement.~      Hypothesis:~        1. There will be a significant clinical difference in post-surgical improvement measured by~          patient reported outcomes when physiotherapy is aided by automated sensor-based~          technology to perform Exergames and track progress, compared to standard physiotherapy~          protocols.~        2. There will be a significant difference in post-surgical improvement in range of shoulder~          movement and patient improvement, measured by patient reported out-comes when~          physiotherapy is aided by automated sensor-based technology to perform exergames and~          track progress, compared to standard physiotherapy protocols.~   "
65817|NCT02705508|"~     Extranodal natural killer/T-cell lymphoma (ENKTL) is an aggressive form of non-Hodgkin's~     lymphoma and shows extremely poor survival. This prospective pilot study to evaluate the~     efficacy and safety of pegylated aspargase(PEG-ASP)combined with etoposide and gemcitabine~     (PEG) treatment in this population.~   "
65818|NCT02705495|"~     In this multi-centre prospective randomized controlled trial the efficacy of segmental~     acupuncture in the prevention of recurrent urinary tract infections will be assessed. The~     study (acupuncture) group will receive 12 acupuncture treatments according to a standardized~     protocol, plus recommendation for use of cranberry products. The control group will receive~     recommendation for use of cranberry products only.~   "
65819|NCT02705482|"~     The purpose of this study is to evaluate MEDI0562 in combination with immune therapeutic~     agents in adult subjects with select advanced solid tumors.~   "
65820|NCT02705469|"~     This is an open label, Phase 1, dose escalation and dose confirmation study of ZEN003694 in~     patients with mCRPC.~   "
65821|NCT02705456|"~     This randomized double-blind two arm controlled clinical trials evaluates the hypothesis that~     the regular use of a tooth paste containing microcrystalline hydroxylapatite provides a~     caries preventive effect in caries-susceptible individuals undergoing orthodontic therapy~     with fixed appliances which is comparable to the caries preventive effect provided by the~     regular use of a fluoridated tooth paste.~   "
65822|NCT02705443|"~     The purpose of this study is to further clarify existing research on the early identification~     and documentation of suspected deep tissue injury (sDTI). Basic principles of physiology~     along with prior research suggests that sDTI has quantifiable amounts of heat (or lack~     thereof) relative to surrounding tissue that will exhibit characteristic thermal signatures~     (temperature). These signatures will be measured and quantitatively recorded using long-wave~     infrared thermography (LWIT) to not only identify sDTI, but to also learn more about their~     pathophysiological evolution. Additionally, the LWIT physiological data will be~     cross-compared to the gold standard of visual assessment and other current standards of wound~     evaluation.~   "
65823|NCT02705430|"~     The aim of the present study is: to examine some of the mechanisms by which a change in life~     style alone or supplemented with a diet supplemented in n-3 PUFA, and associated with this~     computerized life style regulation reduces the development of diabetic complication in a~     small population based study.~      (The NewMe™ / Eco-fusion, Ltd is a science-driven lifestyle change program for better living~     -www.eco-fusion.com)~   "
65824|NCT02705417|"~     The purpose of our study is to compare physical examination alone to color Doppler~     ultrasonography (CDUS) vascular mapping and physical examination in terms of outcomes of~     vascular access and long-term patency.~   "
65825|NCT02705404|"~     The investigators are doing this research to see if they can use small tissue samples or~     fluid to develop a test that will determine if the tissue samples are related or not related~     to each other. The test will use the patient's DNA, which is part of their unique genetic~     material that carries the instructions for the body's development and function. Cancer can~     result from changes in a person's genetic material that causes cells to divide in an~     uncontrolled way and, sometimes, to travel to other organs. Currently, researchers and~     doctors know some of the genetic changes that can cause cancer, but they do not know all of~     the genetic changes that can cause cancer.~   "
65826|NCT02705391|"~     We intend to investigate the clinical application of two emerging imaging modalities for~     which the technical capability is currently in place at Mayo Clinic. The treatment of Ewing~     Sarcoma (ES), Rhabdomyosarcoma (RMS) and soft tissue sarcoma (STS) patients on this study~     will involve multi-disciplinary contributions from nationally recognized sarcoma experts in~     Radiation Oncology, Radiology, Orthopedic Surgery, Pediatric Oncology, Medical Oncology and~     Pathology.~      Patients will undergo additional magnetic resonance (MR) imaging at the same time as the~     standard imaging.~      The ability to compare several imaging modalities within a single cohort of patients~     maximizes the potential of the study to impact the future management of sarcoma patients. The~     collaborative nature of this study, with essential contributions from many departments will~     undoubtedly improve the coordinated care of sarcoma patients and naturally disseminate the~     advanced imaging experience that is acquired.~   "
65827|NCT02705378|"~     Naloxegol has recently been approved by the US Food and Drug Administration to treat opioid~     induced constipation in non-cancer chronic pain patients. Its effectiveness in acute care~     patients, however, is not known. Therefore, the researchers' goal is to investigate whether~     naloxegol is superior to osmotic laxatives for refractory constipation in ICU patients~     already receiving prophylactic stool softeners and simulant laxatives through a double-blind,~     randomized control trial.~   "
65828|NCT02705365|"~     To develop and implement a patient navigator (PN) program for lung screening and smoking~     cessation in community health center primary care practices. This program will be evaluated~     in a randomized controlled trial of primary care patients who currently smoke.~   "
65853|NCT02705040|"~     This study is aimed to evaluate the roles of specific miRNAs in osteoporosis in men.~   "
65829|NCT02705352|"~     Full thickness skin grafts are an essential tool in surgery around the eyelids for~     reconstruction or rehabilitation following injury or surgery. Common conditions where skin~     grafts are needed include cicatricial ectropion, restoration of eyelid function after tumor~     removal, burns to the eyelids, or trauma. Early complications, occurring in the first 2 weeks~     after surgery, are rare: wound dehiscence, necrosis, infection, bleeding, partial or complete~     graft failure. However, late postoperative complications generally categorized as scarring~     (including graft hypertrophy and contraction, keloid formation, and hypo/hyper pigmentation)~     can limit the success and acceptability of the procedure by patients. Scars form following~     any insult to the deep dermis as a result of wound healing. Factors such as age, skin type,~     racial pigmentation, genetics, and sex may influence fibroblast proliferation as part of the~     healing response, resulting in a suboptimal result. Graft contraction is perhaps the most~     worrisome result, since it can result in failure of the initial surgery and may require~     additional surgery to correct. Many treatments have been used to manage these complications:~     corticosteroid injection, cryotherapy, pressure therapy, radiotherapy, laser therapy,~     silicone based products, and antimetabolite therapy. One such antimetabolite, 5-fluorouracil~     (5-FU), has been used over the last 15 years as an adjunct or primary treatment to modulate~     wound healing and scar formation. Other studies have demonstrated safety for cutaneous and~     subcutaneous injection in the periocular region. However, no controlled studies exist. This~     prospective, randomized, and double-blinded clinical study will evaluate the use and benefit~     of 5-FU versus saline in patients undergoing skin grafting for periocular reconstruction. The~     decision for the need for skin grafting will be at the discretion of the attending surgeon~     and will be made separate from enrollment in the study. Surgery will be performed as~     indicated. The study medication or placebo (normal saline) will be administered 2-3 weeks~     after surgery and then every 2-3 weeks afterwards for up to a total of 4 injections. After~     the injections, regular scheduled follow-up will be at 3, 6, and 12 months post-op. Outcomes~     at each study visit (up to 12 months post-operatively) include graft size, color, contour,~     and complications between study treatment group and placebo group.~   "
65830|NCT02705339|"~     Though patients whose tumors harbor EGFR T790M mutation appear to benefit from rociletinib,~     there is a need to understand the molecular mechanisms that lead to primary and acquired~     resistance to rociletinib. The investigators propose to conduct a clinical trial of~     rociletinib of patients with EGFR-mutant NSCLC with activating EGFR mutations (including exon~     19 deletion or L858R mutation), with or without EGFR T790M mutation. In these patients,~     pre-treatment and post-progression biopsy specimens will be subjected to genomic analysis to~     fully understand the clonal evolution and the molecular mechanisms underpinning treatment~     resistance.~   "
65831|NCT02705326|"~     The purpose of this study is to determine if feedback from a three-dimensional real-time~     visualization of the tongue, a program called Opti-Speech, can be used to improve speech.~   "
65832|NCT02705313|"~     Advanced Accelerator Applications is currently pursuing marketing approval for~     177Lu-DOTA0-Tyr3-Octreotate (Lutathera). This expanded access therapeutic protocol aims to~     allow patients suffering from inoperable, somatostatin receptor positive, neuroendocrine~     tumors, progressive under somatostatin analogue therapy to access the investigational~     product, 177Lu-DOTA0-Tyr3-Octreotate (Lutathera), prior to its commercial availability.~   "
65833|NCT02705300|"~     Treatment with FOLFOXIRI (5-fluorouracil, oxaliplatin, irinotecan) can be effective, but it~     has serious side effects, which may require hospitalization.~      The purpose of this study is to investigate whether the addition of tocotrienol can reduce~     the side effects to FOLFOXIRI otherwise leading to hospitalization.~   "
65834|NCT02705287|"~     The goal of this pilot project is to trace the metabolism of vitamin D in the body in~     pregnant and non-pregnant women. At the conclusion of this study the investigators will have~     obtained novel information on the absorption and utilization of vitamin D in women and will~     have validated a new approach. The long-term goal is to better understand the unique~     metabolism of vitamin D during pregnancy.~   "
65835|NCT02705274|"~     Protocol S by DRCR.net has shown that receive Ranibizumab as anti-vascular endothelial growth~     factor (anti-VEGF) therapy with deferred panretinal photocoagulation (PRP) are non-inferior~     to those in eyes that receive standard prompt PRP therapy, however with some visual~     functional benefits and less complications with Ranibizumab arm.~      Applying Protocol S in real world scenario may add cost burden to the patient as patients~     need about 7 injections per year which will cost the patient about 7000 US dollars a year as~     minimum The primary objective of this protocol is to determine the visual acuity outcomes at~     1 year in eyes with proliferative diabetic retinopathy (PDR) using Bevacizumab 1.25 mg~     instead of Ranbizumab to lower the cost burden~   "
65836|NCT02705261|"~     The study is an open trial to evaluate a web-based intervention. The intervention focuses on~     supporting parents to help their children to overcome problems with anxiety. The children who~     are the focus of the study are in the age ranges of 4 - 12 and experience problems with~     separation anxiety, social anxiety, or generalized anxiety as identified by their parents.~     The program will exclude obsessive-compulsive disorder and post-traumatic stress disorder~     that are seen less often in this age group and require somewhat different interventions.~   "
65837|NCT02705248|"~     The objective of this study is to study the association between insulin resistance and~     recurrent spontaneous miscarriage (RSM).~   "
65838|NCT02705235|"~     Stress is an important determinant of pregnancy health behaviors, maternal physiology and~     maternal-infant health outcomes. The purpose of this study is to explain the relationship~     between dimensions of lifetime stress and the stress hormone cortisol in pregnant women.~     Additionally, the study will examine how coping styles help pregnant women to better manage~     stress and improve their health behaviors to achieve the goal of having a healthy baby.~   "
65839|NCT02705222|"~     The aim of this study is to compare dilatation and curettage with hysteroscopy in obtaining~     an accurate diagnosis of the etiology of abnormal uterine bleeding and outlining a mode of~     treatment-specific to the cause.~   "
65840|NCT02705209|"~     The beneficial analgesic effects of Rubefacenciae (redden skin substances), is known since~     1830 as a treatment for pain, cramps, and disorders of the musculoskeletal system. Herbal~     cataplasms containing rubefacient substances, such as Cayenne pepper, are commonly used as~     natural medications to treat painful or aching areas in the case of acute or chronic back~     pain, and rheumatisms. In Vienna and lower Austria, a Cayenne Pepper Cataplasm (CPC)~     application containing Cayenne pepper and Kaolin powder in mixed proportion, is commonly used~     to treat musculoskeletal conditions of pain especially of the low back.~      Therefore, the aim of the present study was to test effects of a series of ten applications~     of CPC prepared with 5% of pepper, investigating the resulting effect on: skin temperature,~     skin sensory functions, pain threshold, and proprioception. Placebo control condition (0%~     cayenne pepper) was also tested. It was hypothesized that a series of 20-minute application~     of a CPC will have significant effects on the measured parameters.~      40 subjects will be randomized into Treatment/control group.~   "
65841|NCT02705196|"~     The purpose of this study is to see if LOAd703 (an oncolytic adenovirus) can be safely given~     to patients with pancreatic cancer. The study will also evaluate whether or not intratumoral~     injection of LOAd703 will support current standard of care treatment to reduce the size of~     the tumor and improve survival of the patients.~      Adenoviruses are known as the common cold virus and most individuals have had multiple~     infections during their lifetime. Oncolytic adenoviruses are adenoviruses that are modified~     so they cannot multiply and spread (known as replicating) properly in normal (e.g. healthy)~     cells, but instead, they infect and replicate very well in cancer cells. This strong~     replication leads to the death of the cancer cell. Oncolytic viruses have been evaluated in~     multiple clinical trials for cancer treatment during the past decade and been proven safe. It~     is common to have a fever the first day or two after virus injection since the immune system~     will react to the virus infection. The immune system can also kill cancer cells but to do so~     it needs to be properly stimulated. Oncolytic viruses alone do not seem to be strong enough~     to activate clinically relevant anti-cancer responses. However, it is thought that if~     additional immune system stimulators are added to the oncolytic viruses they may be able to~     result in clinical relevant antic-cancer responses.~      LOAd703 is an oncolytic adenovirus that has been modified to include additional immune system~     stimulators. Specifically, genes that stimulate the immune system have been added to the~     oncolytic adenovirus. Once the oncolytic adenovirus infects the cancer cells, the genes will~     be expressed, resulting in activation of the immune response so it can attack and kill cancer~     cells.~      In this study, LOAd703 will be given by intratumoral injections. It will be given in addition~     to standard of care treatment with gemcitabine and nab-paclitaxel. Because LOAd703 is an~     experimental therapy, there will be extra visits for disease monitoring and samples~     accordingly to the detailed information below. The LOAd703 is an investigational agent not~     approved by the FDA.~   "
65842|NCT02705183|"~     Rationale: Bone metastases arise in 50% of all patients dying of cancer, increasing up to 70%~     in patients with breast and prostate cancer. The lesions can cause pain and fractures,~     leading to diminished quality of life and poorer survival. Current knowledge concerning~     adequate, personalized treatment of metastatic lesions of the long bones in patients with~     disseminated cancer is insufficient and inconclusive due to lack of large, prospective series~     with patient reported outcome measures. One of the debatable issues is the effectiveness of~     postoperative radiotherapy. It has become common practise due to professional opinion, but~     research evidence is lacking. It is thought that adjuvant radiotherapy improves the~     durability of an implant, prevents progression of the lesion, promotes bone healing, improves~     limb function, minimises pain and reduces the need for reoperations, however none of these~     are certain. Moreover, it is a burden on patient's quality of life (e.g. multiple extra~     hospital visits) causing toxicity and possible side effects (e.g. skin irritation). The true~     beneficial effect, weighing up the possible pros and certain cons, of adjuvant radiotherapy~     is thus unknown.~      Objective: The PORT study aims to demonstrate the non-inferiority of 'surgery only' compared~     to surgery with adjuvant radiotherapy as treatment of impending and actual pathological~     fractures on the pain experienced by patients.~      Study design: A multicentre, prospective, randomised non-inferiority trial nested within the~     OPTIMAL study.~      Study population: All patients with metastases of the long bones undergoing surgery for a(n)~     (impending) pathologic fracture in the participating centres.~      Study intervention: One study arm (A) will receive surgery with adjuvant radiotherapy; the~     other study arm (B) will receive surgery only.~      Main study parameters/endpoints: Primary endpoint is patient reported pain according to a~     numeric rating scale (NRS). Clinical functioning, radiological status, complications and~     survival are secondary endpoints.~   "
65843|NCT02705170|"~     To establish if, in patients with new diagnosis of left ventricular dilatation without~     documentation at the coronary artery angiography of significant coronary artery lesions,~     there is a damage of the coronary microcirculation at the IMR (index of microcirculatory~     resistance) assessment~   "
65844|NCT02705157|"~     Rationale: Bone metastases arise in 50% of all patients dying from carcinoma, increasing up~     to 70% in patients with breast and prostate cancer. The lesions can cause pain and fractures,~     leading to diminished quality of life and poorer survival. Current knowledge concerning~     adequate, personalized treatment of metastatic lesions of the long bones in patients with~     disseminated cancer is insufficient and inconclusive due to lack of large, prospective series~     with patient reported outcome measures.~      Objective: The OPTIMAL cohort aims to describe the quality of life and pain perception of~     patients after local treatment (radiotherapy and/or surgery) of metastases of the long bones,~     for both the entire cohort as well as for specific treatments separately. With this a more~     personalized treatment for metastases in the long bones based on expected survival and~     impending fracture risk can be provided in order to improve functioning and the quality of~     life for the remaining lifetime in patients with disseminated cancer.~      Study design: Observational, prospective, multicentre cohort study.~      Study population: All patients with metastases of the long bones visiting a radiation~     oncologist or orthopaedic surgeon.~      Main study parameters/endpoints: Primary endpoints are patient reported quality of life~     (including functioning) and pain levels. Complications and survival are secondary endpoints.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: Patients in the OPTIMAL cohort will perhaps not directly benefit from their~     participation. Participation will contribute to deriving patient-specific treatment~     modalities for future patients with bone metastases of the long bones. Risks associated with~     participation in the prospective cohort are considered negligible due to the observational~     nature of the study. The burden for the patients lies in completion of questionnaires, which~     is considered to be in proportion with the potential value of this research.~   "
65845|NCT02705144|"~     To characterize stem cell compartments in their niches in different clinical situations~     (non-diseased compared to emphysematous and fibrotic pulmonary tissue) and to assess their~     proliferative and developmental properties in vitro.~      To further implement lung organoid culture system in the drug screening and development of~     patient personalized medicine.~   "
65846|NCT02705131|"~     The purpose of this study is to evaluate the therapeutic effect and safety of the Balance~     Chiropractic Therapy(BCT) on Cervical Spondylotic Radiculopathy and to investigate the~     mechanism of which this efficacy is achieved.~   "
65847|NCT02705118|"~     Fusion imaging of US and MRI is very helpful for interventional procedure such as~     radiofrequency ablation in liver. However, manual registration of US and magnetic resonance~     (MR) imaging is somewhat time-consuming and difficult for less-experienced physicians.~     Recently, automatic registration function was developed to help the fusion of US and CT/MRI~     imaging. The purpose of this trial is to compare the registration time and accuracy of manual~     registration system and automatic registration system.~   "
65848|NCT02705105|"~     The purpose of this study is to characterize the safety and tolerability and determine the~     maximum tolerated dose (MTD) or the recommended fixed dose of the combinations of~     mogamulizumab and nivolumab in subjects with locally advanced or metastatic solid tumors.~   "
65849|NCT02705092|"~     The purpose of the study was to examine the immediate effect of subliminal priming with~     subliminal reward stimuli on standing balance in healthy young adults. The study also~     compared the outcomes with the immediate effects of subliminal priming with supraliminal~     reward stimuli.~   "
65850|NCT02705079|"~     Endoscopic examinations and particularly long-lasting interventions can be uncomfortable for~     patients. Pain and vasovagal reactions are common. Therefore, the implementation is generally~     recommended under sedation and also carried out in practice here.~      The vital signs monitoring to avoid complications is dictated by current national guidelines.~     Necessary measures of monitoring include pulse oximetry and blood pressure measurements. In~     patients with severe heart disease an ECG recording should be used additionally. Moreover,~     the guidelines require that the sedation is clinically monitored continuously to avoid an~     unwanted anesthetic stage.~      Such evaluation, however, is often difficult under clinical conditions and even~     counterproductive, since a constant response and tactile stimulation of the patient (to check~     clinically the depth level of sedation ), interrupts endoscopic complex intervention.~     However, clinical most relevant aspect is the avoidance of unrecognized transition of~     patients from the stage of deep sedation in an anesthetic stage.~      Current recommendations do not take into account new study results from a gender perspective,~     which showed that women and men need a different wake-up time using the EEG derivation means~     by using teh Narcotrend after total intravenous anesthesia, which may be due to different~     total doses of sedatives needed. However, the research group has been demonstrated in a~     previous study that most likely caused by the use of EEG monitoring (Narcotrend) an effective~     adaptation of sedation, in particular a more rapid recovery time by a lower dose of the~     administered sedative for a continuous sedation stage D0-D2 endoscopic retrograde~     cholangiopancreatography-(ERCP).~      In the presented study the investigators evaluate the extent of gender differences in the~     wake-up time after sedation with propofol during endoscopic ultrasound when using EEG~     monitoring.~   "
65854|NCT02705027|"~     A direct application of jejunal tube feeding is necessary especially in patients with~     gastroparesis due of existing diabetes mellitus, postoperative or severe underlying disease.~     Since the jejunal tube feedings, the secretion of gastric juice can be increased, the use of~     probes that allow both: jejunal nutrition, as well as a gastric outflow of secretions are~     beneficial.~      While in a randomized trial of Schwab et al. it could be shown that the use of~     Freka-Trilumina® compared to Dobbhoff probe by so-called drag technique is significantly~     faster there are currently no comparative data to use the Easy-In® probe subsequently~     developed , which is directly introduced through the working channel of the endoscope, and~     thus shortening the procedure time.~   "
65855|NCT02705014|"~     To investigate the hormone response of hypothalamic-pituitary-gonad axis and spermatogenesis~     in male pituitary stalk interruption syndrome patients by pulsatile GnRH therapy.~   "
65856|NCT02705001|"~     This research project is relevant to the identification of the relationship, and its~     significance, between patient morality and a number of demographic, clinical and corporate~     characteristics. Two separate data sets have been compiled linking the existing intervention~     and employment data, one focusing on the admitting nurse and another one considering all the~     nurses involved in each intervention. Several statistical experiments will take place to~     support or reject the main hypothesis: higher nurse education, satisfaction and staffing~     levels result to lower patient mortality.~   "
65857|NCT02704988|"~     Regional lymph node metastasis is a major determinant of local recurrence and overall~     survival rates in patients with colorectal cancer. Because of the poor prognosis associated~     with the presence of lymph node metastasis, stage III colorectal cancer patients should~     receive adjuvant treatment with chemo and / or radiation therapy according to the site of~     tumor. Several authors have investigated the use of revealing solutions for lymph node~     clearance in colorectal cancer. Most studies comparing conventional histopathological~     specimen examination to any lymph node clearing technique showed that the use of revealing~     solutions increases the mean number of lymph nodes harvested, usually in a statistically~     significant manner. It is still controversial the impact of the use of revealing solutions~     for upstaging of lymph node status and consequently for the indication for adjuvant therapy.~     Therefore will be conducted a randomized clinical trial to compares the performance of GEWF~     and Carnoy solutions for the histopathological examination of patients with colorectal~     cancer. The aim of this study is to determine the lymph node revealing solution with the best~     performance (increase in the mean number of lymph node harvested and lymph node upstaging) in~     patients with colorectal cancer.~   "
65858|NCT02704975|"~     The purpose of this single-blinded, randomized clinical trial is to determine the~     effectiveness of dry needling compared to a standard shoulder rehabilitation program on range~     of motion, functional movement, and pain in patients who have undergone shoulder~     stabilization surgery. Measurements of the aforementioned dependent variables will be taken~     at time intervals of four weeks, eight weeks, 12 weeks, and six months post-operatively. It~     is hypothesized that the inclusion of dry needling will result in an increase in range of~     motion, increase in functional movement, and decrease in pain at an accelerated rate when~     compared to rehabilitation alone.~   "
65859|NCT02704962|"~     The investigators hypothesis is that an antipsychotic drug combination of low-dose olanzapine~     plus low-dose trifluoperazine is similar to regular-dose olanzapine monotherapy in efficacy~     and safety for treatment of schizophrenia.The goal of this study is to compare the efficacy~     and safety of the olanzapine (10 mg/d) and olanzapine (5 mg/d) plus trifluoperazine (5 mg/d)~     in the treatment of acute psychotic exacerbations of schizophrenia.~   "
65860|NCT02704949|"~     One of the most effective strategies to decrease radiation exposure during ureteroscopy is to~     use low dose. However, the quality of the image obtained is inferior to full dose image. The~     main concern is to maintain the stone free and complication rate despite the inferior quality~     of image obtained. Our aim was to evaluate if reducing the dose of fluoroscopy to ¼ instead~     of full dose would impact in a reduction of total radiation exposure despite a possible~     increase in fluoroscopy time. Also, if this strategy would impact in operation time, stone~     free rate and complication rate of unilateral semi-rigid ureteroscopy for ureteral stone~     treatment due too less than optimal fluoroscopy image. All patients over 18 years old~     diagnosed with ureteral stone from 5 mm to 20 mm in diameter by CT scan were counseled~     regarding their treatment options. Patients who failed spontaneous passage or medical~     treatment or chose endourologic treatment were included in this study. Patients with abnormal~     urinary anatomy such as horseshoe kidney, pelvic kidney or duplex system were excluded from~     the study.~   "
65861|NCT02704936|"~     Identify, by Lipidomics approaches, biochemical markers of fertility / infertility in sperm~     and seminal plasma linking the success or failure of the artificial insemination (IUI)~   "
65862|NCT02704923|"~     A double-blind, placebo controlled trial of atropine eye drops used by sublingual way for~     preventing Ventilator-Associated Pneumonia.~   "
65863|NCT02704910|"~     The objective of this study is to assess the origins of lateral postural inclination~     presented by some Parkinson disease's patients.~      Several mechanisms could cause lateral postural inclination. Available data allow to suggest~     three hypothesis: (troubles of tonus, perception of vertical perturbation, trouble of~     perception of corporal axis~   "
65864|NCT02704897|"~     This study aims to evaluate if a smartphone-delivered tool can help assess for wound~     infections, and if this improves access to care and results in earlier treatment.~     Participants will be randomised to one of two groups. The intervention group will receive the~     smartphone-delivered wound assessment tool (SWAT), to access if they have concerns about~     their wound. The trial period is 30 days.~   "
65865|NCT02704884|"~     The aim of the present study was to determine the effects of fortified soy milk with L.~     planetarium A7 on a cytokine receptor, an adipokine and renal function biomarkers in type II~     diabetic patients with nephropathy.~   "
65866|NCT02704871|"~     A non-interventional, prospective observational study to assess the performance of SeptiCyte®~     Lab to diagnose patients identified as suspected of sepsis in general medical and surgical~     wards with infection-positive from infection-negative SIRS~   "
65902|NCT02704403|"~     The primary objectives of this study are to evaluate the effect of Elafibranor treatment~     compared to placebo on 1) histological improvement and 2) all-cause mortality and~     liver-related outcomes in patients with nonalcoholic steatohepatitis (NASH) and fibrosis.~   "
65868|NCT02704845|"~     The biopsychosocial model is well established in chronic low back pain (CLBP) research.~     Nevertheless, researchers to date have overlooked the biopsychosocial aspects of Inflammatory~     Low Back pain (ILBP). Most health care providers are biologically oriented in their treatment~     of ILBP, neglecting its possible multidimensional nature. It is true that people with ILBP~     may present with more complex pain and physical limitations than those with chronic~     non-specific low back pain (CNSLBP), but it remains unexplored whether or not these~     limitations are affected by the same pain factors that affect CNSLBP patients. This study~     aims to explore and compare the biopsychosocial back pain profiles of adults with ILBP and~     CNSLBP.~   "
65869|NCT02704832|"~     Randomized trials have already demonstrated that geriatric intervention was able to improve~     survival in the general elderly population but only a few have been performed in cancer~     patients. At the end, these data are not sufficient to consider geriatric intervention as~     validated in this setting. Case Management, coordinated by a geriatrician and a trained~     nurse, could improve prognosis of elderly patients with cancer. This approach, can be~     integrated in daily oncology practice. This strategy will be compared to usual oncological~     management in a randomized phase III trial.~   "
65870|NCT02704819|"~     Balance is crucial for an individual's mobility and independence. Human balance is achieved~     and maintained by a complex set of sensorimotor systems that include sensory input from~     vision, proprioception and the vestibular system (motion, equilibrium, spatial orientation).~     This information is then integrated by the brain. This complexity leads to undiagnosed or~     mistreated patients with balance disorders for long period which can affect their daily~     activities.~      The EMBalance project is a research project funded by the European Union, involving 10~     universities across Europe. Its aim is to create a Decision Support System (DSS) to support~     doctors in diagnosing and treating balance disorders. It will be available to primary and~     secondary care doctors of different specialties, levels of training and in different parts of~     the country.~      The DSS will:~        -  Be used by primary and secondary health care professionals~        -  Assist the doctor on the evaluation and management of dizzy patients~        -  Predict how the balance disorder may progress~        -  Reduce patient waiting time and the onward referrals~        -  Ensure patients receive prompt and efficient treatment plans~      The EMBalance randomised clinical trial (RCT) is a proof-of-concept, multicentre,~     single-blind, and parallel group study, conducted in Belgium, Germany, Greece and United~     Kingdom. At present, the question that this study aims to answer is whether the algorithms~     developed for the EMBalance Platform will yield meaningful information and how these~     algorithms and platform can be improved, performing an offline comparison of the classical~     diagnostic approach and the outcome of the EMBalance platform, without any consequence for~     the patient.~      Patients who present with balance related symptoms at primary care will be randomised to~     either intervention group (non-specialist doctor +DSS) or control group (non-specialist~     doctor -DSS). An overseeing expert will then confirm the diagnosis and management decisions~     made by the non-specialist doctors in order to determine whether the use of the DSS can help~     them in a more precise assessment.~   "
65871|NCT02704806|"~     Researchers use FCM to analyze the immunol cell feature and its corresponding activation~     status, as well as the thromb aspirated through the thromb aspiration device in AMI patients~   "
65872|NCT02704793|"~     Essential tremor (ET) is a low-mortality, though truly burdensome and debilitating condition~     which is known to be the second most common movement disorder of the adult population only~     after restless legs syndrome. The prevalence of the disorder in all age groups has been~     estimated to be 0.9%. Repetitive transcranial magnetic stimulation (rTMS) is an almost safe~     technique which has been used in diagnosis and treatment of many neurologic and psychiatric~     conditions. Recent studies have shown that cerebellum has a significant role in development~     of ET and that rTMS could exert therapeutic effects on its motor symptoms. In this study~     researchers will recruit at least 30 subjects among patients visiting at the Specialty Clinic~     of Mashhad Medical University according to researchers exclusion and inclusion criteria and~     after signing a written informed consent, will randomly be assigned to either real or sham~     rTMS. On the real rTMS arm, patients will be treated with 900 pulses of 1 Hz rTMS on 90% of~     resting motor threshold (RMT) delivered over each cerebellar hemisphere for 5 consecutive~     days and sham treatment will be performed with the same protocol using a small device placed~     on the TMS coil (not visible to the patients) producing electrical stimulation (less than 3~     mili amperes), to simulate the sensation of real TMS. Subject's ear will be protected with~     earplugs during both real and sham stimulations. After 2 months of follow-up, patients will~     undergo crossover and receive the other treatment as described above. Patients would be~     assessed using Fahn-Tolosa-Marin scale at the baseline and again on days 5, 12, and 30 after~     each real or sham treatment session by a blinded researcher. Data will be analysed by another~     researcher who is also blind.~   "
65873|NCT02704780|"~     This study evaluates intra umbilical vein injection of 800 µg versus 400 µg misoprostol for~     the treatment of retained placenta to reduce the need of manual removal of placenta under~     general anaesthesia~   "
65874|NCT02704767|"~     Tarceva now was established first-line therapy for advanced lung adenocarcinoma with mutant~     EGFR patients.However,the benefit lasted for about 6-8 months.So we consider to add~     apatinib,a tyrosine kinase inhibitor of VEGF,to the therapy of these patients.~   "
65875|NCT02704754|"~     Problems sleeping are common after exposure to highly threatening experiences and can occur~     with and without a diagnosis of posttraumatic stress disorder (PTSD). Established treatments~     for PTSD are limited for addressing insomnia and many insomnia treatments appear to be~     limited in the context of PTSD. Suvorexant is FDA approved for insomnia and among approved~     drugs has a unique mechanism of action that may be well suited for targetting arousal at~     night dysregulated by trauma. The investigators will evaluate the efficacy of suvorexant for~     insomnia that developed in relation to trauma exposure, utilizing a placebo control, and~     polysomnography to identify biomarkers of response, in a six week trial.~   "
65876|NCT02704741|"~     The CO2RE laser system is a fractional CO2 laser that is FDA approved under a 510(k) K101321~     for dermatologic procedures requiring ablation and coagulation of soft tissues, including the~     skin Eligible subjects will undergo 3 treatments in 4±1 weeks interval on the Vagina~     (External/Vulva and Internal/Vagina) with the CO2RE device according to study protocol.~      Subject will return for to 5 follow-up (FU) visits: 1 week ± 2 days post first treatment~     visit and 1, 3, 6 and 12 months after last (third) treatment (± 2 weeks).~      Methodology described in protocol to evaluate efficacy of treatments will be carried out at~     each visit at the clinic.~   "
65877|NCT02704728|"~     The purpose of this study is to assess the safety and tolerability of Bacteroides~     thetaiotaomicron (Thetanix®)) capsules in young people aged 16 to 18 years with stable~     Crohn's disease.~   "
65878|NCT02704715|"~     The purpose of this study is to evaluate the postoperative pain after general anesthesia of~     orbital diseases and ocular tumor patients.~   "
65903|NCT02704390|"~     The purpose of this study is to evaluate the long-term safety and efficacy of~     ORADUR®-Methylphenidate in children and adolescents with ADHD.~   "
65883|NCT02704650|"~     The purpose of this study is to:~        1. Identification and characterization of ovarian carcinoma well-known biomarkers,~          carcinoma antigen 125 (CA125) and Human epididymis protein 4 (HE4) and other potential~          biomarkers in vaginal fluids obtained from ovarian cancer patients.~        2. Quantification and calibration of identified biomarkers in vaginal discharge collected~          from ovarian cancer patients in comparisons to samples collected from healthy~          volunteers.~        3. Comparison analysis of biomarkers levels in vaginal fluids vs. serum.~        4. Quantification and calibration of identified biomarkers in vaginal discharge collected~          from ovarian cancer patients diagnosed in various stages.~   "
65884|NCT02704637|"~     HeadSense (HS)-1000 device, a proprietary non-invasive brain monitor, is expected to safely~     and accurately monitor physiological signs of the brain with minimal discomfort to patients,~     providing information about normal or abnormal brain-related conditions and providing~     decision-making support for physicians. The investigators hypothesize that the HS-1000 is~     capable of detecting vasospasm using the raw acoustic data derived from the noninvasive~     procedure.~   "
65885|NCT02704624|"~     Thus, the aim of the current study is to assess the influence of vitamin D deficiency and,~     consequently, of serum calcium deficiency in the body composition, muscular activity, bone~     mineral density, fatigue, and exercise tolerance of CD patients. Secondly, it also aims to~     determine the impact of vitamin D supplementation on this population.~   "
65886|NCT02704611|"~     The aim of this study is to assess the effectiveness of transcranial direct current~     stimulation (tDCS) in treating fibromyalgia.~      Participants will be randomly assigned to one of the two groups: Group I (Intervention group)~     tDCS (2mA for 25 minutes on 5 consecutive days/week for 2 weeks with the anode centered over~     M1 bilaterally Anodal tDCS for 20 minutes at 1.5 mA (15 s ramp in and 15 s ramp out) will be~     applied daily for 10 consecutive days (5 sessions/week) . The anodal electrode (24 cm² with~     current density of 0.08 mA (2mA/24 cm²) will be placed over the left primary motor area in~     group I, and the reference electrode (24 cm² will be fixed over the contralateral arm~     (extracephalic).~      Daily tDCS was given to prolong and stabilize these long-lasting after-effects. Group II will~     receive sham tDCS will be applied using the above described parameters in group I. For sham~     tDCS, the placement of the electrodes, current intensity, and ramp time was identical to real~     tDCS stimulation group; however, the stimulation lasted only for 30 Sec. However, since none~     of the patients have been experienced tDCS previously, they were unaware of which stimulation~     is real and which sham is. The investigator responsible for delivering tDCS had no contact~     with the patients. All study participants will be followed up by the same evaluation sheet~     and by an evaluator who are blinded to the type of intervention she /he has~     received.Evaluation will be done pre assessment, post 5 sessions, post 10 sessions, post one~     month and post 2 months by using wide spread pain index (WPI) & symptoms severity of~     fibromyalgia, measuring visual analogue scale (VAS), Depression and anxiety will be assessed~     using Hamilton Depression Scale (HDS) and anxiety scale, pain sensitivity threshold by using~     Electronic Von Frey unit EVF4 . Determination of human beta-endorphin level before start~     sessions and after end 10 sessions.~   "
65887|NCT02704598|"~     This is a prospective, randomized study, aiming to evaluate patients with Deep Venous~     Thrombosis in lower limbs and the recanalization rates evaluated with DUPLEX ultrasound, as~     so the clinical outcomes in patients submitted to oral anticoagulation with Rivaroxaban~     versus Warfarin.~   "
65888|NCT02704585|"~     Time to stable reading of oxygen saturation at the delivery room will be compared between two~     different devices.~   "
65889|NCT02704572|"~     The purpose of this study is to determine the optimal timing of zoster vaccination to induce~     both higher cell-mediated immunity and humoral immunity in adult patients aged over 50 with~     history of zoster within 5 years.~   "
65890|NCT02704559|"~     A randomized, open-label, oral dose, crossover study to explore drug-drug interactions~     between DWC20155 and DWC20156 in healthy subjects.~   "
65891|NCT02704546|"~     The purpose of this study is to explore the possible effects of MPH use on physiological~     functions among ADHD\ADD patients, by performing a set of physical trials to assess aerobic~     and anaerobic capacity, to characterize the tendency for muscle break down while performing~     monitored moderate physical effort and to assess the physiological strain while performing~     moderate exercise in heat load conditions by using the heat tolerance test.~   "
65892|NCT02704533|"~     MAVACHE is a sequential dose and schedule optimization trial of intravenous immunization with~     PfSPZ Vaccine in 18 to 54 malaria-naïve, healthy adult volunteers receiving 9x10^5,~     1.35x10^6, or 2.7x10^6 PfSPZ per dose and a total dose between 2.7x10^6 and 8.1x10^6 PfSPZ~     followed by CHMI with 3,200 fully infectious PfSPZ (PfSPZ Challenge).~      PfSPZ Challenge (7G8) to assess vaccine efficacy, safety, tolerability and infectivity of~     ascending PfSPZ doses will be assessed in healthy, malaria-naïve volunteers.~   "
65893|NCT02704520|"~     This trial evaluates a novel imaging method called magnetic resonance tumour regression grade~     (mrTRG) to assess how well a tumour has responded to chemoradiotherapy in patients with~     rectal cancer. The TRIGGER Trial aims to evaluate mrTRG as a tool for stratifying the~     management of patients according to their response to treatment.~   "
65894|NCT02704507|"~     A randomized, split-face, placebo-controlled, double-blind, single-center clinical trial~     comparing topical retinoid on half the face and retinoid plus topical steroid on the other~     half.~   "
65895|NCT02704494|"~     The aim of this study is to evaluate the safety and effects of resveratrol in treatment of~     diabetic nephropathy.~   "
65896|NCT02704481|"~     The primary outcome of this study is to compare the effectiveness of a second complete course~     of 200 mg mifepristone and 800 mcg misoprostol for ongoing pregnancy following~     mifepristone-misoprostol medical abortion.~   "
65897|NCT02704468|"~     Chronic kidney disease(CKD) patients have high incidence of coronary artery problems event~     after renal transplantation. And remain a major cause of mortality. The major risk marker is~     arterial stiffness. The cardio-ankle vascular index (CAVI) is a new index of overall~     stiffness and can estimated the risk of atherosclerosis.~      Fibroblast growth factor 21 (FGF-21) is a metabolic regulator that plays important role in~     cardiac remodeling elevated FGF-21 have been reported in coronary heart disease or carotid~     artery plaque and could be biomarkers for atherosclerosis disease Investigators aimed to~     study the association between CAVI and FGF-21 and their relations to various parameters that~     can contribute to cardiovascular disease eg. homocysteine Echocardiogram findings and other~     traditional basic factors.~   "
65898|NCT02704455|"~     This study is a multicenter, prospective cohort study of patients diagnosed with primary~     ciliary dyskinesia, the clinical information of recruited patients, including clinical~     manifestations, lung function, chest imaging, quality of life and other indicators, will be~     followed for 10 years.~   "
76653|NCT02563665|"~     All patients with chronic kidney disease (stages 3, 4 and 5) and chronic dialysis patients~     with HCV infection attending nephrology and Hepatology OPD or getting outpatient dialysis at~     the dialysis unit of ILBS.~   "
65911|NCT02704286|"~     The investigators have created an interactive knee osteoarthritis (OA) risk calculator that~     estimates a user's risk of developing symptomatic knee OA as well as the user's risk for~     undergoing a total knee replacement (TKR) within their lifetime. To test the impact of the~     calculator, the investigators recruited OA-free subjects from Amazon's Mechanical Turk.~     Participants were randomized to either access general information about OA or use the risk~     calculator in addition to accessing general OA information. The investigators hypothesized~     that participants randomized to the risk calculator arm would have more accurate perception~     of their knee OA risk and would have increased willingness to change risky behavior compared~     to the general OA information group.~   "
65912|NCT02704273|"~     This is a pre-Phase 1 prospective, non interventional clinical assessment study to evaluate~     XLMTM subjects aged 3 years and younger. Many of these clinically relevant measures have not~     yet been routinely assessed in this population and may provide important insight on the~     natural history of XLMTM and for future evaluation of potential therapies.~   "
65913|NCT02704260|"~     search for a genetic cause of vascular endofibrose~   "
65914|NCT02704247|"~     The aim of this porject is to test the Cardiospace system that integrates several medical~     devices to monitor the cardiovascular system:~        -  ECG~        -  Brachial blood pressure~        -  Continuous finger blood pressure~        -  Ultrasound~        -  Laser doppler + iontophoresis Cardiospace will be used in space station to monitor the~          cardiovascular system of astronauts for research purpuse.~   "
65915|NCT02704234|"~     Vulvodynia is a women's pain condition. Women have pain in their vulva, the area in their~     genitals between the vagina and labia (lips of the vagina). They also have pain when they~     have sexual intercourse or insert anything in the vagina. Sometimes they have so much pain,~     that they cannot have sex.~      This research is being done for two reasons. The first reason is to test a set of special~     needles called double-blinded acupuncture needles to give acupuncture treatments (one is a~     real needle and the other is a fake needle). The second reason is to develop a protocol~     (checklist) that will be used in this and future studies, and to identify and resolve any~     procedural problems. The protocol will be first tested by the principal investigator who is~     also an acupuncturist. The investigator will perform acupuncture using the protocol, if~     necessary change the protocol, and then teach a second acupuncturist using the modified~     protocol how to use the double-blinded acupuncture needles.~      The real needle called the penetrating needle penetrates the skin. The fake needle called the~     non-penetrating placebo touch needle does not penetrate the skin but it touches the skin so~     it feels like a needle is being inserted. It has a blunt tip.~      Participants can't see which needle they are getting acupuncture with because the needles are~     housed in a double-blinded needle device which has two tubes (an inner and an outer) that~     neither the acupuncturists nor the participants can see through.~      If a fake acupuncture needle can be used in acupuncture research like a sugar pill is used~     for drug studies to see how well the real medicine works, the investigators can see how~     effective acupuncture is. The investigators will be testing these needles to treat~     participants with vulvodynia.~   "
65916|NCT02704221|"~     This study is a feasibility trial, testing the hypothesis that among sedentary mothers of~     behaviorally at-risk preschool-aged children, those who receive behavioral parent training~     (BPT) programs and concurrently increase their physical activity levels will demonstrate~     improved parenting and child behavior outcomes compared to those who receive BPT but remain~     sedentary.~   "
65917|NCT02704208|"~     The Thrive With Me (TWM) trial is testing the efficacy of a mobile enhanced website aimed~     at improving Antiretroviral Therapy (ART) adherence for HIV-positive men who have sex with~     men (MSM). TWM is a technology-delivered peer-to-peer social support intervention with social~     networking and gaming components. In addition to real-time peer-to-peer support capabilities,~     the TWM intervention provides participants with Antiretroviral Therapy (ART) adherence~     self-monitoring tools, medication dose reminders, and HIV-related informational content.~   "
65918|NCT02704195|"~     Impact of unilateral modulation of deep brain stimulation of the subthalamic nucleus on~     freezing of gait in Parkinson's disease~   "
65919|NCT02704182|"~     The objective of this study is to detect the effect of trans-cranial direct current~     stimulation on postoperative pain and opioid consumption in total knee arthro-plasty~     patients. Fifty patients undergoing unilateral TKA will be randomly assigned to receive 4~     sessions, total of 80 minutes of real (n=25) or sham tDCS (n=25). Stimulation will be given~     on 4 consecutive postoperative days, group 1 will receive real stimulation with the active~     electrode over the leg representation of the motor strip (cortical motor area of the leg) and~     the reference electrode over the arm, group 2 will receive Sham tDCS. Pain level will be~     evaluated according to visual analogue scale (VAS) and LANSS pain scale before (base line)~     after 1st, 2nd, 3rd and 4th sessions.~   "
65920|NCT02704169|"~     The last decade has seen progressive advances in RT delivery, such as intensity modulated~     radiation therapy (IMRT)and image-guided radiation therapy (IGRT), which now allow highly~     precise radiation dose delivery. Together, IMRT and IGRT offer the potential of more~     selective treatment of the primary tumour and surrounding neck nodes by reducing the dose~     inflicted on critical organs at risk without compromising tumour dose and. IMRT has been~     shown to significantly decrease radiation-induced toxicity, and is now considered standard~     treatment for H&N tumors. With these advances in delivery technology, the accurate definition~     of the target is emerging as the weakest link in the radiotherapeutic treatment chain.~     Accurate target definition is the primary link on which all subsequent treatment planning and~     delivery depend and is therefore critical for successful RT. Incorrect target definition can~     result in poorer outcomes through either less tumour control, more normal tissue toxicity, or~     both. Computed x-ray tomography (CT) is the standard volumetric imaging modality for RT~     because of its high resolution, accurate definition of anatomy and its intrinsic measure of~     electron density necessary for accurate dose calculation. However, its ability to distinguish~     between tumour and normal tissue is limited due to a lack of contrast for structures of~     similar electron density and image artifacts for objects of high density. This additional~     noise can result in large inter-observation variability. Disease visible on endoscopy can be~     contoured and registered to the planning CT, allowing inclusion of superficial disease~     invisible on the volumetric CT image dataset into the treatment plan.~   "
65921|NCT02704156|"~     The safety and efficacy of five-fraction stereotactic body radiation therapy treating locally~     advanced pancreatic cancer~   "
65923|NCT02704130|"~     This single-center, prospective randomized controlled trial (RCT) is designed to compare the~     outcomes and clinicopathologic results of trans arterial embolization (TAE) and microwave~     ablation (MWA) combination therapy with MWA monotherapy for the treatment of early (stages 0~     and A) hepatocellular carcinoma (HCC). The primary aim of this study is to test the following~     hypothesis: 2-year intrahepatic disease-free survival does not differ between patients~     receiving the experimental therapy (MWA + TAE) and patients receiving the standard therapy~     (MWA alone) as treatment for early stage HCC. Secondary aims are: 1) to determine the~     clinical feasibility of TAE + MWA in HCC patients with a small tumor burden using patient~     demographics and disease characteristic data and 2) to determine the effect of TAE on~     radiographic tumor characteristics in this patient cohort.~   "
65924|NCT02704117|"~     The purpose of this study is to test the effects of non-invasive neuromodulation,~     transcranial direct current stimulation (tDCS), on brain function in individuals with~     obsessive-compulsive disorder (OCD). This study is focused on the mechanism(s) by which brain~     stimulation might change the functioning of regions implicated in OCD, and thereby inform~     possible future therapeutic uses.~   "
65925|NCT02704104|"~     This study is designed to monitor patient safety after excision of skin lesions and~     subsequent application of AC5 topical hemostatic agent and to assess the performance of AC5~     for controlling bleeding in skin wounds.~   "
65926|NCT02704091|"~     The purpose of the study is to demonstrate that diosmectite efficacy is superior to placebo~     regarding time to recovery of an acute diarrhoea episode presumed of infectious origin in~     adult subjects.~   "
65927|NCT02704078|"~     Endobronchial Ultrasound Guided Transbronchial Needle aspiration (EBUS-TBNA) is a firmly~     established modality for diagnostic evaluation of mediastinal lesions. The procedure is~     routinely performed at the Department of Pulmonary Medicine and Sleep Disorders, AIIMS, New~     Delhi since 2012. Transesophageal approach for fine needle aspiration of mediastinal lesions~     using the Endobronchial Ultrasound (EBUS) scope [also described as Transesophageal~     Bronchoscopic Ultrasound Guided Fine Needle aspiration (EUS-B-FNA)] (also routinely performed~     in the department) and has been described as a safe and efficacious modality. EUS-B-FNA is~     usually employed when EBUS-TBNA is not feasible or excessive cough or secretions necessitate~     switch to esophageal route. We hypothesize that EUS-B-FNA as the primary approach has similar~     diagnostic performance as EBUS-TBNA and is associated with greater patient and operator rated~     procedure comfort and lesser requirement of anaesthesia medications for evaluation of~     patients with mediastinal lesions easily accessible with either of the two approaches.~      We propose to undertake a prospective randomized comparison of Transesophageal (EUS-B-FNA)~     versus Transtracheal (EBUS-TBNA) approach for fine needle aspiration using the same EBUS~     scope in patients referred for endo-sonographic evaluation of mediastinal lesions. A total of~     100 serial patients (with Subcarinal and/or Lower Left paratracheal located mediastinal~     lymphadenopathy at least >1cm in Short axis diameter) shall be included. After consent and~     preliminary investigations, patients shall be randomized equally into the two approaches.~     Procedure will be performed under local anaesthesia (topical lignocaine) and i.v. sedation~     (midazolam and fentanyl) in the bronchoscopy laboratory. The primary objective will be~     comparison of proportion of diagnostic and adequate aspirates in the two groups. Secondary~     objectives will include operator rated cough (VAS), Operator rated overall procedure~     satisfaction (VAS), dose of midazolam and fentanyl administered, lignocaine dose and total~     procedure duration.The primary data analysis shall be for the performance characteristics of~     the primary approach. All the aspirates shall be analysed by the same pathologist for final~     interpretation.~   "
65928|NCT02704065|"~     End-stage renal disease related to AA amyloidosis is well characterized but there is limited~     data concerning patient and graft outcomes after renal transplantation. The aim of this study~     is to evaluate the clinical features of, and risk factors for recurrent AA amyloidosis, as~     well as the effects of these factors on the ultimate outcome of renal allografts.~   "
65929|NCT02704052|"~     Venous thromboembolism (VTE) encompasses deep venous thrombosis and pulmonary embolus, and is~     the proximate cause of death in over 100,000 hospitalized patients per year. To put this in~     better context, VTE kills more people each year than the annual morbidity from motor vehicle~     crashes and breast cancer combined. Surgeons commonly provide enoxaparin, a low molecular~     weight heparin, for VTE prophylaxis. Enoxaparin's activity is quantified by anti-Factor Xa~     (aFXa) levels. Studies of enoxaparin metabolism in patients with traumatic injury, thermal~     injury, or those undergoing reconstructive surgery have shown that standard dosing can result~     in inadequate aFXa levels, likely from the hypermetabolic state associated with significant~     injury. Small studies have associated subtherapeutic aFXa levels with increased risk for life~     or limb-threatening VTE events. Prior work from has shown that 2-10% of highest risk surgical~     patients have a VTE event despite enoxaparin prophylaxis. The investigators believe that~     surgical patients would benefit from an individualized dosing regimen for enoxaparin~     prophylaxis and that individualized dosing will decrease observed rates of life or~     limb-threatening post-operative VTE events.~      This project will critically examine the pharmacokinetics of prophylactic doses of enoxaparin~     in surgical patients, and will evaluate how alteration of enoxaparin dose magnitude and~     frequency affects peak and trough aFXa levels as well as risk for re-operative hematoma. If~     subtherapeutic aFXa levels are observed, the study will design, implement and test a clinical~     protocol to optimize post-operative aFXa levels. Although not an explicit Aim, this study~     will also provide important preliminary data on VTE rates in surgical patients with in range~     and out of range aFXa levels.~   "
65930|NCT02704039|"~     The goal of this research program is to develop a simple, noninvasive diagnostic device for~     assessing skin pathology without the need for a biopsy. The device being studied is a single~     system capable of collecting three spectroscopy measurements (Raman, diffuse reflectance and~     laser induced fluorescence spectroscopy) from skin lesion sites. In order to accomplish this~     objective, the investigators propose to: 1) develop biophysical model for Raman spectroscopy~     of skin cancers, 2) conduct a clinical pilot study to collect MMS data from a minimum of 250~     patients to determine the diagnostic accuracy (sensitivity and specificity) of MMS for~     diagnosing skin malignancy.~   "
65931|NCT02704026|"~     Malnutrition and growth retardation are common in children with inflammatory bowel disease~     (IBD), especially in Crohn's Disease (CD). Malnutrition is associated with disease type,~     anatomical location, severity of disease and age of patient. Recently, it is reported that~     almost all children with CD and half with Ulcerative Colitis (UC) have reduced lean mass,~     however, body fat alteration are not well defined.~      The aim of this prospective and observational study was to evaluate nutritional and growth~     status and body composition of children with IBD using anthropometric measurement and~     bioelectrical impedance during 1 year follow-up.~   "
65932|NCT02704013|"~     It is a single-center, prospective, interventional, single-arm study. Aim is to investigate~     which variables are significantly correlated with prolonged anticholinergic treatment (>6~     months) in children with overactive bladder (OAB). Investigated variables will include~     urinary neurotrophins and inflammatory cytokines, sonographic biomarkers, symptom score~     scale, demographics, and urodynamic findings. Secondary aim is to analyze sensitivity and~     specificity of urinary biomarkers in diagnosis and management of OAB compared to urodynamics~     and treatment outcome.~   "
65933|NCT02704000|"~     This study evaluates the efficacy and cost-effectiveness of two platforms for delivering home~     visiting programs in the poor urban setting of Sao Paulo's western region: a program~     delivered by a newly trained cadre of Child Development Agents, and a program delivered by~     Community Health Agents employed by the government as part of the Family Health Strategy~     (ESF). The program will randomly select 400 mother-child dyads to follow a curriculum that is~     currently being adapted to the local context. The primary outcome of the program will be~     cognitive development for children aged 9 to 15 months old at baseline (21-27 months at~     endline) The secondary outcomes will include child physical development as well as maternal~     mental health.~   "
65934|NCT02703987|"~     The purpose of this study is to investigate the effect of a fermented infant formula on~     lactose digestion in lactose intolerant adults.~   "
65935|NCT02703974|"~     The study will collect and analyze quantitative data regarding handwashing behaviors among~     school-aged children to determine the impact of nudges compared to handwashing and hygiene~     education programs.~      Based on the success of the preliminary pilot, we hypothesize nudges leading to higher rates~     of handwashing than traditional handwashing and hygiene education programs.~   "
65936|NCT02703961|"~     The standard treatment of local advanced cervical cancer is concurrent chemoradiotherapy. The~     3 year disease free survival was about 50-70%. The distant metastasis is the main cause of~     failure in local advanced cervical cancer treated with 3-dimensional conformal radiotherapy~     (3D-CRT) or intensity modulated radiotherapy (IMRT). The purpose of this study is to~     investigate the efficacy and tolerance of concurrent and adjuvant chemotherapy with cisplatin~     and docetaxel for local advanced cervical cancer. It was expected that the 3 year disease~     free survival would be increased by 10% with this new treatment schedule.~   "
65937|NCT02703948|"~     This is a multi-center, open-label, single-arm study to assess the safety of an injection~     technique with Restylane Silk in lip augmentation and correction of perioral rhytids .~   "
65938|NCT02703935|"~     Background: Cancer-related fatigue is the most common concern reported by Childhood cancer~     survivors. Empirical evidence is needed to find out an appropriate strategy for ameliorating~     its impact.~      Purposes: To examine the effectiveness of an adventure-based training programme in promoting~     regular physical activity, reducing fatigue and enhancing quality of life among Hong Kong~     Chinese childhood cancer survivors.~      Design and Subjects: A randomised controlled trial (RCT), two-group pre-test and repeated~     post-test, between subjects design has been conducted. Recruitment of subjects has been~     carried out in an outpatient clinic, and through the Children's Cancer Foundation and~     Sunshine Group, which are non-profit voluntary organizations with the aim to provide~     education and supportive services to parents of Hong Kong Chinese childhood cancer survivors.~      Intervention: Participants in the experimental group have joined a four-day adventure-based~     training programme, which contains education talks, a workshop and adventure-based training~     activities. Those in the placebo control group has received an amount of time and attention~     (leisure activities organized by a community centre) that mimick that received by the~     experimental group.~   "
65939|NCT02703922|"~     Giant cell arteritis (GCA or temporal arteritis or cranial arteritis) or Horton disease is a~     vasculitis that occurs in older adults, affecting vessels of medium and large caliber. The~     diagnosis of GCA is a challenge for general practitioners and specialists. Since 1970, it is~     based on a combination of clinical, biological and histological signs. Temporal artery biopsy~     (TAB) was the reference method until recently. However, TAB has many drawbacks. Therefore,~     researches of the past 20 years have been intended to develop alternative diagnostic methods.~     This was notably the case of the color Doppler ultrasound (CDU) since the description by~     Wolfgang Schmidt of the halo sign. Although European and British recommendations put CDU as~     second line method, many authors suggest the possibility to do without TAB in many cases. In~     addition, many practitioners believe that it is not ethical to use an invasive unprofitable~     procedure like TAB, and have already been using CDU in their routine practice. However, no~     diagnostic algorithm validating this approach in a prospective series has been published to~     date. Therefore, the present study aim at validating a diagnostic algorithm of giant cell~     arteritis using color Doppler imaging of temporal arteries and cervicocephalic axes as first~     screening method.~   "
65940|NCT02703909|"~     Obesity affects more than 78 million adults in the United States and it is estimated that 35%~     of the US population is obese. Currently, more than 179,000 bariatric procedures are~     performed in the US each year with the majority of these surgeries using laparoscopic~     techniques. Surgeons often request deep neuromuscular blockade (NMB) during surgery, but~     there is no evidence that a deep NMB improves surgical conditions and that the surgeons can~     discriminate between a moderate and deep NMB. There is also evidence that maintaining low~     insufflation pressures during laparoscopic surgery may decrease postoperative pain. The goal~     of this prospective, randomized, assessor-blinded controlled trial is to test the hypothesis~     that deep NMB provides optimal surgical conditions during laparoscopic bariatric surgery in~     the morbidly obese patient. It will also determine if deep NMB allows the surgeon to utilize~     lower insufflation pressure and decreases postoperative pain requirements after laparoscopic~     bariatric surgery.~   "
65941|NCT02703896|"~     Effect of orally administered two equal and consecutive doses of proton pump inhibitors,~     omeprazole, lansoprazole, esomeprazole , rabeprazole and pantoprazole and Histamine 2~     receptor antagonists cimetidine, ranitidine,famotidine,nizatidine and lafutidine without and~     with a prokinetic agents domperidone, metoclopramide and erythromycin on intragastric pH,~     volume and bile refluxate.~   "
65942|NCT02703883|"~     The purpose of this study was to evaluate the effectiveness of body weight-supported~     treadmill (BWST) training on static balance impairment in adults with incomplete spinal cord~     injury (SCI) in chronic stage~   "
65943|NCT02703870|"~     The purpose of this Study is to determine whether non-invasive transcranial direct current~     stimulation (tDCS) is effective in increasing rehabilitation effects after stroke in visual~     Cortex.~   "
65955|NCT02703714|"~     This is an open label phase II trial to examine efficacy and safety of a novel combination of~     pembrolizumab plus induction GM-CSF in patients with advanced biliary cancers treated at~     UCSF.~      This phase II study will examine the efficacy and safety of the novel combination of~     pembrolizumab plus induction GM-CSF in advanced biliary cancer patients with the hypotheses~     that the combination may increase proportion of patients with overall response compared to~     contemporary historical controls, with acceptable safety.~   "
65944|NCT02703857|"~     The surgical site infection is one of the most important causes of postoperative morbidity.~     The appropriate antibiotic prophylaxis is one of the most effective ways to prevent surgical~     site infections. The recommendations of the French Society of Anesthesia Resuscitation on~     antibiotic prophylaxis in long surgeries are based on low documentation, including frequency~     and dosage of reinjection.~      The main objective of the study is to describe the tissue and plasma pharmacokinetics of~     cefoxitin after repeated injections.~      This is an open monocentric study (phase 4) including adults aged 18 to 80 years in need of~     major abdominal surgery whose foreseeable time exceeds 4 hours and justifying an antibiotic~     prophylaxis by cefoxitin.~      They receive 2 g cefoxitin parenterally at least 30 minutes before the incision and then~     every 2 hours until closing.~      The primary endpoints are:~        -  Total and plasma free concentrations of cefoxitin 0, 10, 30, 60, 90, 120 minutes after~          start of each infusion cefoxitin~        -  Tissue free concentrations of cefoxitin every 20 minutes after the start of the first~          infusion cefoxitin until skin closure~        -  Urinary concentrations of cefoxitin~   "
65945|NCT02703844|"~     The purpose of this study is to determine whether caloric vestibular stimulation improves~     symptoms of Parkinson's Disease.~   "
65946|NCT02703831|"~     Two recent studies showed that having two attending spine surgeons performing complex adult~     spine deformity surgery instead of one, decreased complications, unplanned surgeries within~     30-days [Ames], 90-day readmissions, wound infection, pulmonary embolism/deep vein thrombosis~     and post-operative neurologic complications [Sethi]. However, both studies were retrospective~     and did not evaluate any cost-savings associated with having two spine surgeons instead of~     one performing complex spine deformity surgery.~      Most cost-effectiveness studies have used traditional accounting (TA) methods to determine~     costs. A few cost-effectiveness studies have used time-driven activity-based costing (TDABC)~     [Kaplan] in medicine [Au, Balakrishnan] and none in spine surgery.~      Objectives: The objectives of the study are (1) to determine if dual spine attendings reduce~     downstream costs compared to a single spine attending for complex spine surgeries using~     traditional accounting methods; and (2) to demonstrate an application of the TDABC method to~     evaluate the operating room phase during complex adult spinal deformity surgery and compare~     it to traditional accounting methods (TA).~   "
65947|NCT02703818|"~     This is a prospective, multi-center post-market study of the Senza System in subjects with~     chronic, intractable pain of the upper extremities. Data at follow-up visits will be compared~     to Baseline data collected at the beginning of the study.~   "
65948|NCT02703805|"~     Building on an earlier pilot study, this randomized controlled trial will compare the~     effectiveness of a 12 week community YMCA-based wellness program specifically designed for~     people with stroke (Fit for Function) to a standard YMCA membership.~   "
65949|NCT02703792|"~     This qualitative study uses focus group methodology and purposive sampling with the aim of~     obtaining views of Care Home Support Service staff and other stakeholders about their~     experiences of a redesigned National Health Service (NHS) Care Home Support Service.~     Individual stakeholder focus groups will be conducted with General Practitioners (GP), care~     home staff, relatives of residents in care homes, service-user representatives (Total N=32,~     across 4 focus groups). This study forms part of a larger evaluation of the CHSS service;~     service improvement workshops will be conducted with Oxford Health NHS Care Home Support~     Service, Community Nursing and Community Mental Health staff that are working in the 102~     participating homes. Each participant who consents will take part in a focus group to explore~     their experiences of a redesigned NHS care home support service. Participants will be~     involved in the study for up to six months from gaining informed consent until last contact~     with the research team when a summary of the research will be sent. The data will be analysed~     using thematic analysis and applied with the Reach, Effectiveness, Adoption, Implementation~     and Maintenance (RE-AIM) framework.~   "
65950|NCT02703779|"~     Explore stem cell collection with or without bortezomib with in-vivo purging in multiple~     myeloma.~   "
65951|NCT02703766|"~     This study aims to examine the role of weight gain in adipose tissue immune cell influx and~     development of obesity related cardiometabolic disorders. Adipose tissue-mediated chronic~     systemic inflammation is implicated in the development of cardiometabolic disorders in~     obesity. Therefore, resolution of adipose tissue inflammation may be key to ameliorating~     obesity-associated dyslipidemia, insulin-resistance, and cardiovascular disease.~     Proinflammatory cytokines contribute to the initial influx of immune cells into adipose~     tissue during weight gain. However, mechanisms regulating these cytokines in the adipose~     tissue milieu and the effects of weight gain on adipose tissue are not completely understood.~      The study proposes to investigate the molecular events contributing to increased infiltration~     of macrophages and T-cells into adipose tissue during weight gain. The central hypothesis is~     that in lean subjects (with low body fat mass), healthy fat gain which is associated with~     decreased expression of proinflammatory cytokines. However, in obesity (high body fat mass),~     adipose tissue is altered, which permits increased expression of inflammatory cytokines and~     further fat gain results in influx of immune cells. To test the hypothesis, adipose tissue~     from well characterized lean (control, with low body fat) and obese individuals (with high~     body fat) at baseline and after a modest 5% weight gain will be used. Adipose tissue samples~     after subsequent weight loss will also be examined.~      For this study, obesity will be defined by body composition rather than body mass index~     (BMI), as several studies have shown that BMI does not adequately define obesity and several~     individuals with normal BMI may indeed have high body fat mass. Individuals with body fat~     content ≤25% for men, & <35% for women) will be considered lean and individuals with body fat~     content >25% for men, ≥35% for women will be considered obese.~   "
65952|NCT02703753|"~     This study evaluates the effect of a lifestyle intervention for women with a pregnancy wish~     who have a high risk on perinatal morbidity because of overweight or obesity. Half of the~     patients will receive the lifestyle intervention while the other half will receive usual~     care. It is hypothesized that an effective lifestyle intervention directed towards healthy~     living, including reduction of overweight or obesity and, if applicable, smoking reduction,~     health problems in mothers and their offspring can be prevented.~   "
65953|NCT02703740|"~     This study evaluates the injection of a hyaluronic acid dermal filler with lidocaine 0.3% in~     the treatment of nasolabial folds (NLF). Each patient will receive 1 concentration in a NLF~     (20 mg/mL) and an other concentration in the other NLF (24 mg/mL).~   "
65954|NCT02703727|"~     Oral anticoagulation therapy (OAC) entails a high potential for adverse events and strict~     adherence is needed.Thus, medication review and identification of safety issues and knowledge~     gaps about OAC is critically important. The polymedication check (PMC) is a reimbursed~     intermediate medication review focusing on adherence and medication management for Swiss~     primary care. Investigators aime to assess the impact of the PMC extended with a~     semi-structured interview focusing on OAC.~   "
67750|NCT02680132|"~     Subjects to compare the single dose bioavailability of Torrent's Esomeprazole Delayed Release~     Capsule 1 × 40 mg and Nexium 1× 40 mg of AastraZeneca LP, USA. Dosing periods of studies were~     separated by a washout period of 7 days.~   "
65956|NCT02703701|"~     The United States spends over $8,000 per capita annually on health care and its health care~     system is more expensive than other developed countries. Even with high per capita costs and~     a high proportion of physician specialists, the US lags in health care performance from~     patients' perspectives.~      The hospital emergency department (ED) is often the portal of entry for patients seeking~     health care services and is therefore an ideal setting for initiatives to improve efficiency~     of care delivery and patient satisfaction. Reduction in wait times, enhanced information~     delivery and ED staff service quality all have a positive influence on patient perception of~     health care quality and satisfaction.~      Prior studies have attempted to increase patient satisfaction by improving staff~     communication and courtesy, implementing a patient satisfaction team in triage, and~     delivering information to patients in a timely manner. Another strategy to increase the~     efficiency of ED operations is adding a physician to triage to perform brief medical~     screenings and initiate necessary patient testing and treatment. This contrasts to usual~     practice in which physicians evaluate patients only following registration and nurse~     assessment of illness or injury severity.~   "
65957|NCT02703688|"~     Few treatments have been developed for young children with obesity from diverse backgrounds.~     The present study will develop and test an intervention designed to improve preschool obesity~     in Latino children. The intervention will focus on improving eating, activity, and sleep~     behaviors and the home environment for improved weight status.~   "
65958|NCT02703675|"~     Research has shown that lowering brain temperature may have good results in heart attack~     patients. Lowering brain temperature may be a promising treatment for stroke patients. The~     Excel Cryo Cooling device drops brain temperature by cooling the blood in arteries in the~     neck. The device is a neck collar with a cooling pack which when shaken can reach low~     temperature within seconds. The collar is placed around the patient's neck and the cooling~     pack is applied to the front of the neck and held in place. This device provides stable~     cooling irrespective of participant size or weight. The objective of this study is to test~     the value of using Excel Cryo Cooling device in dropping brain temperature in 3 different~     groups of adult participants:~      i. Healthy adult volunteers, ii. Adult participants with normal body temperature in intensive~     care unit iii. Adult participants with fever in intensive care unit~   "
65959|NCT02703662|"~     To date, there have been no prospective randomized controlled trials that compare various~     biologic mesh materials in the context of abdominal wall reconstruction. As a result, this~     proposal describes a 'head to head' randomized controlled trial (RCT) between 2 of the~     market's most popular biologic meshes. Strattice (noncross-linked porcine dermis, LifeCell~     Inc.) will be compared to Permacol (cross-linked porcine dermis, Covidien Inc.) in a~     randomized manner. Although there are significant differences between these mesh products~     with regard to procurement, tissue processing and cost, clinical controlled trials are needed~     to compare their performance.~   "
65960|NCT02703649|"~     Letrozole is considered an established treatment for ovulation induction.The most common~     protocol is daily dose of 2.5-7.5 mg starting day 3-5 of the cycle for 5 days.Another~     described protocol is single high dose 20mg Letrozole given on day 3 of the cycle.~      Our aim is to compare the single high dose Letrozole protocol to daily low dose protocol.~   "
65961|NCT02703636|"~     To evaluate the efficacy of rivastigmine patch with 1-step titration on cognitive function~     measured as change from baseline to week 24 in the total score of Mini-Mental State~     Examination (MMSE) in mild to moderate Alzheimer's disease (AD) patients who failed to~     benefit from other cholinesterase inhibitors (ChEIs).~   "
65962|NCT02703623|"~     The goal of this clinical research study is to find out if the combination of apalutamide~     (also known as ARN-509 or JNJ-56021927), abiraterone acetate, and prednisone can be given~     with either ipilimumab or cabazitaxel plus carboplatin to control metastatic CRPC. The safety~     and effectiveness of these drug combinations and their effect on the immune system will also~     be studied.~      This is an investigational study. Apalutamide is not FDA approved or commercially available.~     It is currently being used for research purposes only. Prednisone is FDA-approved and~     commercially available as a corticosteroid. Ipilimumab is FDA approved to treat metastatic~     melanoma. Abiraterone acetate, cabazitaxel and carboplatin are FDA-approved and commercially~     available for the treatment of metastatic CRPC. It is considered investigational to give this~     combination of drugs for the treatment of metastatic CRPC.~      The study doctor can explain how the study drugs are designed to work.~      Up to 265 participants will be enrolled in this multicenter study. Up to 265 will take part~     at MD Anderson.~   "
65963|NCT02703610|"~     The purpose of this study is to perform a randomized, double blind 2-arm clinical trial of~     the comparative efficacy of 2 oral analgesics in the the management of acute pain in elderly~     patients who present and then are discharged from the ED.~   "
65964|NCT02703597|"~     Objectives:~      Objective 1: Conduct focus group discussions with 15 adolescents in order to design~     game-based social activities (GSA's) aiming to reduce smoking curiosity and increase positive~     connections.~      Objective 2: Through a short-term pilot evaluation, compare the use of a smoking prevention~     interactive experience (ASPIRE) alone (ASPIRE group) with the use of GSAs along with ASPIRE~     (GSA-ASPIRE group).~      Hypothesis 2.1: Adolescents in the GSA-ASPIRE group will be more likely to decrease in their~     intention to smoke, when compared with adolescents in the ASPIRE group.~      Hypothesis 2.2: Adolescents in the GSA-ASPIRE group will be more likely to (a) reduce in~     smoking curiosity and (b) engage in positive social influence, when compared with adolescents~     in the ASPIRE group.~      Exploratory hypothesis 2.3: (a) Smoking curiosity and (b) Positive social influence are~     related to the decrease in intention to smoke.~      Objective 3: Conduct in-depth interviews with 15 adolescents in order to obtain feedback on~     how GSAs can be best improved as part of future research.~   "
65965|NCT02703584|"~     All the studies, demonstrating improved oocyte maturity and high pregnancy rate with the dual~     trigger are all retrospective. The investigators therefore aim to perform a prospective~     randomized controlled study in normal responders, comparing cycles triggered with hCG to~     those triggered with hCG+GnRH agonist.~   "
65966|NCT02703571|"~     Phase Ib dose escalation in advanced solid tumors to identify dose for Phase II dose~     expansion in advanced or metastatic pancreatic cancer and KRAS-mutant colorectal cancer.~     Open-label, nonrandomized.~   "
77406|NCT02553798|"~     This is an open-label, long-term safety study of DRM04 Topical Wipes, enrolling up to 660~     subjects with primary axillary hyperhidrosis who participated in either the DRM04-HH04 or~     DRM04-HH05 studies.~   "
65967|NCT02703558|"~     This study is a prospective randomized controlled study. Female patients over 18 years of~     age, who present for treatment of pelvic organ prolapse and/or stress urinary incontinence at~     the Pelvic Floor Center at the Johns Hopkins Bayview Medical Center, and who consent to~     undergo a urogynecologic surgical procedure, will be considered for inclusion in the study.~     Their histories will be reviewed by their attending surgeon and if they meet inclusion and~     exclusion criteria, they will be recruited for participation. The primary investigator and~     co-investigators (attending physician, fellows) will determine patient eligibility. Regarding~     privacy issues, the patients will be consented for both the procedure and for the study with~     careful attention made to emphasize patient confidentiality. When the patient presents for~     surgery, they will be randomized to receive either preoperative pyridium or intraoperative~     fluorescein or no dye. Given the color differences between the dyes, blinding will not occur.~     The process for recruitment will be consistent and any deviations from the protocol will be~     reported to the Johns Hopkins Internal Review Board.~   "
65968|NCT02703545|"~     Various centers around the world are currently investigating the feasibility and yield of~     surveillance for pancreatic cancer in high-risk individuals. Evidence is beginning to~     accumulate that surveillance may lead to the early detection of non-invasive precursor~     lesions and asymptomatic early stage cancer. Ultimately, the goal of surveillance is to~     reduce mortality in these high risk individuals, but before this can be confirmed many~     research questions need to be answered. While the numbers of high-risk individuals screened~     in each separate screening facility are likely too small to properly address many of these~     questions, pooling data comprises a sizable sample size providing unique research~     opportunities. The objective of this study is retrospectively review all cases of high-risk~     individuals participating in our pancreatic surveillance program in whom 1) a suspicious~     precursor lesions was detected for which a pancreatic resection was performed and 2) in whom~     an advanced malignant disease was diagnosed. The de-identified information will be entered~     into an international multicenter database registry.~   "
65969|NCT02703532|"~     The objective of this study is to identify the potential benefits of a home-based,~     intervention designed to facilitate carepartners' roles in stroke survivor rehabilitation.~     Stroke survivors and caregivers will participate in pairs. Stroke survivors will receive~     constraint induced movement therapy (CIMT). Caregivers of stroke survivors will be randomized~     to traditional caregiver education or a web based intervention for the duration of stroke~     survivor therapy. By learning the best way to involve family members in therapy,~     investigators hope to decrease the harmful effects of stroke.~   "
65970|NCT02703519|"~     This prospective, controlled, clinical, intervention study measures the number of uterine~     Cesarean section scars and median myometrial thickness of women who underwent two Cesarean~     sections six to nine months after their last Cesarean section using transvaginal ultrasound.~      It is the purpose of the study to assess if a resection of the uterine scar from a previous~     Cesarean section during a second Cesarean section could lead to a decrease in risk for~     subsequent pregnancies.~   "
65971|NCT02703506|"~     This project aims to study the effectiveness of a pain education program in the improvement~     of chronic pain and disability/impairment. Assuming the definition established in the United~     States in 1975 on the fourth working group of the National Conference on Preventive Medicine:~     Health education must be a process that informs, motivates and helps people to adopt and~     maintain practices and healthy lifestyles, environmental advocates changes necessary to~     facilitate these objectives and professional training and directs research towards the same~     objectives.  Once the need of educating patients is stablished on subjects with diseases, it~     is necessary to encourage them to actively participate on the control of them and to achieve~     significant improvement of adherence~   "
65972|NCT02703493|"~     This is a Phase I study looking to evaluate the safety of dose escalated stereotactic~     radiotherapy (SRS) without exceeding the maximum tolerated dose in patients with high-risk~     human papilloma virus (HPV)- unassociated oropharyngeal squamous cancer.~   "
65973|NCT02703480|"~     The proposed study design is a randomized controlled trial, split mouth design, to compare~     the two different vertical augmentation procedures: Titanium mesh (Ti-mesh) technique and~     Guided Bone Regeneration (GBR) technique with a high-density polytetrafluoroethylene (d-PTFE)~     membrane.~   "
65974|NCT02703467|"~     The purpose of this study will be to determine whether there is any role for measuring~     Hydrogen Sulphide (H2S) in the exhaled breath in terms of management of the patient with~     asthma.~      The investigators will recruit patients with a range of severity of asthma and health~     volunteers. Levels of Hydrogen Sulphide will be measured in exhaled breath and blood. Also~     exhaled Nitric Oxide, Spirometry and asthma symptom scores will be measured at each study~     visit. Participants will attend either 2 or 4 separate visits.~      The investigators will determine whether there is a relationship between exhaled Hydrogen~     Sulphide and asthma severity.~   "
65975|NCT02703454|"~     The study is designed as a prospective, multicenter, single-blind, randomized study to assess~     the safety and effectiveness of FIRM-guided radiofrequency (RF) ablation procedures for the~     treatment of symptomatic PAF. The subjects will be blinded to study treatment for the~     duration of the study period.~   "
65976|NCT02703441|"~     The research and innovation programme Food´n´Go - Empower aims to develop, test and implement~     health technology solutions for active involvement and increased empowerment of elderly~     patients and their relatives solving well-known problem areas as malnutrition and inactivity.~      The prototype was developed in 2013. The project is a collaboration between departement of~     internal medicine in Copenhagen University Hospital, one local municipality and a private~     it-company. The technology is a tablet computer, used by elderly patients to order and~     register food intake during hospitalization. The tablet is also used to get inspiration for~     physical activities during hospital admission and after discharge and for registration of~     physical activities.~      The aim of this study is to test if an adjusted version of the Food´n´Go technology through~     active involvement of the elderly patient can prevent weightloss and loss of muscle strength~     during hospitalization and after discharge.~   "
65977|NCT02703428|"~     The LUCY Study is a prospective, consecutively enrolling, non-randomized multi center~     post-market study to evaluate the low profile (14F) Ovation® Abdominal Stent Graft Platform~     when used in the endovascular treatment of female patients.~   "
65978|NCT02703415|"~     Management of acute pain is one of the most important tasks of perioperative pediatric~     anesthesia. The alleviation of pain has been defined by the Society of Pediatric Anesthesia,~     on its 15th annual meeting as a basic human right, irrespective of age, treatment primary~     service responsible for the patient care. Pro-inflammatory cytokines increased by surgical~     trauma indirectly modulate pain through the release of substances like nitric oxide, oxygen~     free radicals, prostaglandins, and excitatory amino acids, inducing peripheral and central~     sensitivity and hyperalgesia. There has been growing interest in determining the possible~     immune consequences of analgesic administration for the management of postoperative pain~   "
65979|NCT02703402|"~     ABSTRACT: Low back pain is one of the most frequent causes of incapacity. The prevalence of~     this syndrome is 60-85% for the survival of the individuals. Among the most promising~     strategies of low back pain intervention, is the physical activity that is usually associated~     with a long list of health benefits.~   "
65980|NCT02703389|"~     The amount and speed of emergency department (ED) discharge instructions often make it~     difficult for patients/caregivers to know the final diagnosis and to remember instructions.~     We hypothesize that a video on ear infections and antibiotics' role in their management will~     facilitate caregiver understanding and will increase the likelihood of caregivers properly~     following discharge instructions.~      To verify this hypothesis, a large multi-centre clinical trial is needed. Prior to this, it~     is only ethical to conduct a smaller 'pilot' trial. Previously healthy children (6 months-5~     years) diagnosed with mild ear infections at the McMaster Children's Hospital ED will be~     eligible to participate. If the child and caregiver decide to participate, before discharge,~     the caregiver will either: 1)watch the aforementioned video, 2)be given a pamphlet with the~     same information, or 3)standard of care (no additional information). Participants will fill a~     knowledge survey before discharge. The research assistant will contact all participants by~     phone to determine if the caregiver followed the discharge instructions.~   "
65981|NCT02703376|"~     This study is safety and proof-of-concept study for oral prednisolone in the treatment of~     esophageal stricture after esophageal surgery. The patients who develop the severe esophageal~     strictures from 28 days after esophageal surgery are included. Primary outcomes are Safety~     and Success rate of this treatment.~   "
65982|NCT02703363|"~     Bipolar disorder is a leading cause of disability worldwide. A high proportion of patients~     with bipolar disorder experience persistent depressive symptoms that do not respond to~     standard drug treatments. Recent evidence has suggested that anti-inflammatory treatment may~     reduce depressive symptoms. Minocycline is a tetracycline antibiotic with good central~     nervous system (CNS) penetration that has been suggested to be effective as an adjunct drug~     in improving depressive symptoms. Celecoxib, a selective cyclooxygenase 2 (COX-2) inhibitor,~     has also shown promising results in the treatment of depressive symptoms. In this factorial~     design, double blind, randomised controlled trial the investigators will determine the~     efficacy of minocycline and/or celecoxib as an adjunct to treatment as usual (TAU) in~     patients experiencing a depressive phase of bipolar I or II disorder. The investigators~     hypothesise that augmentation with minocycline and/or celecoxib will lead to an improvement~     in depressive symptoms in participants in comparison with placebo.~   "
65983|NCT02703350|"~     The study will be conducted in participants with type1 diabetes on insulin injection therapy~     to investigate how the body processes LY900014 and the effect of LY900014 on blood sugar~     levels. Side effects and tolerability will be documented. The study will be conducted in two~     parts (Part A and Part B) to achieve its objectives. Participants are expected to enroll in~     both parts.~   "
65984|NCT02703337|"~     The study will be conducted in participants with type 2 diabetes on insulin injection therapy~     to investigate how the body processes LY900014 and the effect of LY900014 on blood sugar~     levels. Side effects and tolerability will be documented. The study will be conducted in two~     parts (Part A and Part B) to achieve its objectives. Participants are expected to enroll in~     both parts.~   "
65985|NCT02703324|"~     This study will evaluate a blood sugar lowering insulin, LY900014, delivered by an insulin~     pump continuously under the skin. The study will be conducted in participants with type 1~     diabetes mellitus to investigate how the human body processes LY900014 and its effect on~     blood sugar levels when it is delivered via an insulin pump. Side effects and tolerability~     will be documented.~   "
65986|NCT02703311|"~     The Cardioband Transcatheter System (Cardioband) is indicated for the treatment of secondary~     (functional) mitral regurgitation (FMR). The Cardioband is a transcatheter system, deployed~     on the beating heart through a transseptal approach. The Cardioband is deployed along the~     posterior annulus of the mitral valve (MV) and is adjusted under trans-esophageal guidance on~     the beating heart. A CE mark study with 30 subjects has been completed and documented~     reduction of severity of mitral regurgitation (MR) and improvement in 6- minute walk test in~     subjects with moderate to severe MR.~      Study objectives are to test the efficacy of the Cardioband in improving MR and heart failure~     symptoms in patients with symptomatic (New York Heart Association (NYHA) Class III-IVa),~     severe MR in the post-marketing setting, And to evaluate the safety of the Cardioband system~     in the post-marketing setting.~   "
65987|NCT02703298|"~     TRX-818 is a new small molecule chemical entity being developed as a potential anti-cancer~     therapeutic by TaiRx, Inc. TRX-818 is a potent anti-cancer agent in numerous human cancer~     cell lines. The objectives of this study are to determine the safety profile of TRX-818~     including identification of dose limiting toxicity (DLT) and maximum tolerated dose (MTD) in~     Asians and determine the recommended dose and regimen(s) to initiate Phase 2.~   "
65988|NCT02703285|"~     The study aims to validate the interpretation of breath sounds by medical personnel~   "
65989|NCT02703272|"~     The purpose of this study is to confirm that the pharmacokinetics of ibrutinib in pediatric~     participants is consistent with that in adults (part 1) and to assess efficacy (event-free~     survival [EFS]) of ibrutinib in combination with rituximab, ifosfamide, carboplatin, and~     etoposide (RICE) or rituximab, vincristine, ifosfamide, carboplatin, and idarubicin (RVICI)~     background therapy compared to RICE or RVICI background therapy alone (part 2).~   "
66019|NCT02702882|"~     The study evaluates the effect of Fenugreek seed extract (Furosap) in management of~     symptomatic hypogonadism as fenugreek seed extract is a testosterone booster. Fenugreek seeds~     extract are known to possess protodioscin and the extract is reported to improve sperm count,~     sperm morphology and protective effect on male reproductive system. All the participants will~     receive one capsule (500 mg) of furosap once a day.~   "
65990|NCT02703259|"~     The purpose of the investigators' study is to assess the efficacy of a single dose of~     preoperative gabapentin within an enhanced recovery after surgery protocol in acute~     postoperative pain reduction for women undergoing a minimally invasive hysterectomy.~     Participants who consent to participate will be randomized to either a control group without~     gabapentin or to a study arm and receive gabapentin 600 mg prior to their planned surgery.~     The investigators will collect data on postoperative narcotic use, subjective pain as rated~     by a numeric pain scale, in addition to any adverse effects of single dose gabapentin use.~   "
65991|NCT02703246|"~     In this study the investigators will perform a randomized trial to compare the surgical~     outcomes of vaginal versus abdominal morcellation of the uterus during hysterectomy. In~     minimally invasive gynecologic surgery small incisions are made in the abdomen and pelvis so~     that a hysterectomy can be performed by laparoscopy. The challenge is then to remove the~     uterus, which may be quite large, through these small incisions. One option is to morcellate~     the uterus and remove the tissue through either a small abdominal incision or an incision in~     the vagina. When an organ is morcellated it is cut into smaller pieces so that it can be~     removed, section by section, through a small incision. The investigators will compare these~     two methods of tissue removal to see whether one results in better surgical outcomes or~     increased intra-operative or post-operative complications. The primary outcome will be the~     time it takes to perform the surgery (operative time). Secondary surgical outcomes that will~     be studied include the amount of blood lost during surgery, post-operative complications, and~     readmission to the hospital.~   "
65992|NCT02703233|"~     This will be a randomized control trial. All patients for whom an emergency provider~     determines that abscess drainage or laceration repair are necessary will be considered for~     enrollment. The provider must be willing to participate in the study and be certified to use~     Nitrous oxide. The investigators providers completed a training course to be certified to use~     Nitrous oxide. The patient must be age 18 or greater, consent to participate in the study,~     and be able to complete a satisfaction survey. If the patient states there is a possibility~     of pregnancy, the investigators will regress to our standard of care and perform a urine~     pregnancy test. Patients with a first trimester pregnancy will be excluded. Patients who~     agree to enroll in the study will be randomized to Nitrous oxide versus oxygen (to be~     administered through the same system), and will complete a survey after the procedure, as~     will the provider. There will be a separate block randomization for each procedure. Providers~     may select other agents of choice for analgesia/sedation, such as local anesthesia, and pain~     medications, based on their clinical judgment. If the patient appears to have inadequate~     analgesia during the procedure, the provider can elect to treat as is typically done (pain~     medications or local anesthetics) at their discretion. The survey will ask patients to give a~     self-reported pain score before and during their procedure (both to be completed after the~     procedure). It will also ask the patient/guardian and provider for a satisfaction level with~     the analgesia during the procedure. In addition, side effects and procedure start and stop~     time will also be documented. In addition to the survey, the investigators will document~     clinical characteristics including diagnosis, size of laceration or abscess, additional~     medications required and dosages, comorbidities, age, and gender. Other data that will be~     gathered will include which adjunctive analgesics/anesthetics were used.~   "
65993|NCT02703220|"~     Sleep-disordered breathing (SDB or sleep apnea) is very common among elderly Veterans and~     leads to increased morbidity and mortality in this population. The proposal aims to identity~     whether oxygen, finasteride and acetazolamide can be effective in reducing unstable breathing~     and eliminating sleep apnea in the elderly via different mechanisms. This proposal will~     enhance the investigators' understanding of the pathways that contribute to the development~     of sleep apnea in the elderly. The investigators expect that the results obtained from this~     study will positively impact the health of Veterans by identifying new treatment modalities~     for sleep apnea. A cumulative effect of the investigators' research will fulfill the~     long-term goal of improving the quality of life of elderly Veterans suffering from sleep~     apnea and its potential life-threatening complications.~   "
65994|NCT02703207|"~     Cognitive dysfunction in the aging Veteran population is a growing health concern in the~     Veterans Health System. It is not known whether OSA coexisting with COPD will enhance the~     risk for cognitive dysfunction. The investigators sought to investigate whether these two~     highly prevalent diseases, that often co-exist as the 'Overlap Syndrome', combine to enhance~     cognitive impairment in the elderly Veteran population. Thus, the investigators will study~     whether elderly patients with Overlap syndrome have increased cognitive deficits compared~     with OSA or COPD alone. Additionally, treatment of OSA with positive airway pressure (PAP)~     has been shown to improve neurocognitive function in moderate-to-severe OSA while cognitive~     decline in COPD may be reversible through treatment with long-term oxygen therapy. The~     investigators will also study whether treatment with positive airway pressure (PAP) and~     supplemental oxygen vs PAP alone will improve cognitive function and improve quality of life~     of elderly Veterans.~   "
65995|NCT02703194|"~     The study has been designed as a 12-month, open-label, randomized, controlled study comparing~     the use of prednisone mono-therapy and prednisone and leflunomide combination therapy in~     treating patients with IgG4-related disease.~   "
65996|NCT02703181|"~     The current study is designed to assess the safety, tolerability and pharmacokinetics (PK) of~     additional repeat doses of epelsiban in healthy females, and will be the first dosing~     experience of repeat dosing at higher doses in women with this compound.~      This study is a 14 day, randomized, placebo-controlled, double blind (sponsor unblind),~     repeat dose, ascending cohort, dose escalation study in healthy, female volunteers. Upon~     successful completion of the Screening period, a subject will be enrolled in the study. The~     study will be composed of three periods: Screening, Treatment and Follow-up. A subject's~     total time involved in the study will be approximately six weeks.~      Cohorts will be conducted sequentially. Each subject will be enrolled in only one cohort. Ten~     subjects will be enrolled in each cohort and randomized to epelsiban (n=8) or placebo (n=2).~   "
65997|NCT02703168|"~     This is a follow-up study with patients, who participated in the Straumann clinical study~     CR06/03. The objective is the assessment of long-term data (8 and 10 years after~     implantation) on the performance of immediate and early (28-34 days post implantation)~     non-occlusal loaded Straumann Tissue Level Implants with SLActive surface when used to~     support single crowns or 2-4 unit fixed dental prostheses in the posterior maxilla and~     mandible.~      The primary objective is of the study is to analyse the change in crestal bone levels 8 and~     10 years post-surgery compared to 6 months, 1 year, 2 years and 3 years post-surgery in the~     immediate and early loading group.~   "
65998|NCT02703155|"~     The aim of this study is to establish if the self-administered electronic Oral Glucose~     Tolerance Test kit can increase the annual uptake of screening for CFRD in children who are~     between 10 and 17 years of age with CF.~   "
67751|NCT02680119|"~     Subjects to compare the single dose bioavailability of Torrent's Esomeprazole Mg DR Capsule~     1×40 mg and Nexium 40 mg DR Capsule containing Esomeprazole 40 mg of AastraZeneca LP, USA.~     Dosing periods of studies were separated by a washout period of 5 days.~   "
65999|NCT02703142|"~     Gastric conduit ischemia or anastomotic breakdown after esophagectomy with cervical~     esophagogastrostomy often cause severe complications, such as leakage, necrotic organs, and~     strictures. Thus, the purpose of this study is the safety and efficacy of endoscopic~     evaluation about reconstructive organs after esophagectomy. The investigators evaluate~     endoscopic predictions using classifications in acute phase after esophagogastrostomy.~   "
66000|NCT02703129|"~     Migraine is a common medical condition. Several studies suggest that obesity and/or weight~     gain are risk factors for aggravating migraine course, especially increase the frequency of~     headache episodes. The aim of the current study was to evaluate whether nutritional~     intervention would be able to improve clinical parameters (as assessed by MIDAS and HIT) of~     patients with migraine.~   "
66001|NCT02703116|"~     The purpose of this study is to assess the feasibility, acceptability and test the initial~     efficacy of eSBI, (electronic screening and brief intervention for alcohol use) coupled with~     STTR (Seek, Test, Treat, and Retain) in comparison to STTR only among YMSM (young men who~     have sex with men) and YTW (young transgender women) on frequency of substance use and~     engagement within the HIV (human immunodeficiency virus) and PrEP (pre-exposure prophylaxis)~     care continuum.~   "
66002|NCT02703103|"~     The aim of the study was to evaluate the new mechanical chest compression machine LifeLine~     ARM in healthcare professionals in simulated model of cardiac arrest.~   "
66003|NCT02703090|"~     The primary aim is to utilize near-infrared spectroscopy (NIRS) in patients under general~     anesthesia to measure changes in brain blood flow in the bilateral somatosensory cortices and~     the prefrontal cortices in response to noxious stimulation.~   "
66004|NCT02703077|"~     This study compare 2 techniques to treat difficult bile duct stones endoscopically~   "
66005|NCT02703064|"~     Poly cystic ovary syndrome (PCOS) is the most common endocrine disorder in women of~     reproductive age, affecting approximately 5%-10% of all females worldwide . PCOS is a~     hormonal disorder that involves multiple organ systems within the body. Its cardinal features~     are Hyperandrogenism and polycystic ovary (PCO) morphology. Women with PCOS may complains~     about irregular menstrual periods or heavy menstrual bleeding, infertility, excessive growth~     of coarse facial and body hair, obesity, oiliness of the skin, seborrhea, and cystic acne.~   "
66006|NCT02703051|"~     Phase 1, open-label, parallel, active-controlled, multiple IV dose, proof of concept study~     conducted at one study center in the United States (US).~   "
66007|NCT02703038|"~     Cardiogenic shock (CS) is defined as an organ hypoperfusion secondary to low cardiac output.~     Catches diagnostic management, and therapeutic monitoring of these patients remain highly~     variable from one center to another and even from one doctor to another within the same team.~     The management protocols are often not standardized or non-existent.~      It appears therefore necessary to make an inventory of the management practices of the CS in~     France in 2016, prerequisite to a common work of standardization of practices and the~     creation of specialized networks to support these complex patients.~   "
66008|NCT02703025|"~     Clinical evaluation of GCB-70 in overweight subjects: An Add-On Study~   "
66009|NCT02703012|"~     First clinical application of an algorithm for individual adjustment of ventilator settings~     using electrical impedance tomography.~   "
66010|NCT02702999|"~     The purpose of this study is to see whether women at a gestational age of 30 weeks or more~     without comorbidities, does performance of serial 3rd trimester growth ultrasounds increase~     the frequency of identifying abnormalities in fetal growth or amniotic fluid, when compared~     with women who only receive indicated ultrasounds?~   "
66011|NCT02702986|"~     10 Patients with Locally Advanced Pancreatic Cancer, no further responsive to neoadjuvant~     treatments but with a Stage-III disease will be submitted to imILT (Immunostimulating~     Interstitial Laser Thermotherapy). Safety and feasibility of imILT on LAPC will be evaluated~     as primary objective. Secondary objectives will be QoL after imILT, study of the immune~     reaction after imILT, oncological analysis of patients suffering from LAPC submitted to~     imILT.~   "
66012|NCT02702973|"~     The high doses of interferon α-2b therapy in patients with melanomas of the skin may induced~     retinopathy, especially in the patients with hypertension or diabetes, so these patients~     should be followed up after treatment.~   "
66013|NCT02702960|"~     This trial is a phase II, single arm, open-label, single center study to assess a~     reduced-intensity conditioning regimen, bone marrow transplantation and high dose PTCy in~     recipients of a partial liver allograft from a Human Leukocyte Antigen (HLA)-matched or~     -haploidentical living related donor in patients with HCC.~      The primary objective of this trial is to characterize recurrence-free survival at 1 year~     following bone marrow transplantation among recipients of prior partial liver transplantation~     from the same donor.~   "
66014|NCT02702947|"~     Benign prostatic hyperplasia (BPH) is a nonmalignant enlargement of the prostate Prunus~     domestica bark contains three groups of active constituents: phytosterols (including~     beta-sitosterol), pentacyclic triterpenoids (including ursolic and oleaic acids) and ferulic~     esters of long-chain fatty alcohols (including ferulic esters of docosanol and tetracosanol).~      The phytosterols, particularly beta-sitosterol, are found in numerous plants and are~     anti-inflammatory, inhibiting the synthesis of prostaglandins. Beta-sitosterol has been shown~     to be useful in cases of BPH by helping to reduce the normally elevated levels of~     prostaglandins in these patients.~   "
66015|NCT02702934|"~     Amylose-amylopectin ratio may influence the rate of starch digestion. This randomized~     controlled study evaluated the postprandial metabolic effects of amylose-rich- wheat- based~     rusks in overweight subjects.~   "
66016|NCT02702921|"~     This prospective, randomized, controlled, multi-center study will collect and compare data~     from the surgeon's current Standard Of Care stapler (for Pulmonary Artery/Pulmonary Vein~     transection) and powered vascular stapler.~   "
66017|NCT02702908|"~     This study aims at estimating the incidence of second primary malignancies as well as the~     overall survival among metastasized prostate cancer (mPC) and metastasized castrate-resistant~     prostate cancer (mCRPC) patients not treated with radium-223-dichloride.~   "
66018|NCT02702895|"~     MTN-032 is an exploratory sub-study of the ASPIRE and HOPE trials that will utilize~     qualitative In-Depth Interviews (IDIs) and Focus-Group Discussions (FGDs) to explore~     socio-contextual and trial specific issues which affected participants' adherence to the~     dapivirine vaginal ring (VR).~   "
66020|NCT02702869|"~     A system for prospective data-collection is being implemented by the Duke Cleft &~     Craniofacial Center so that it may analyze clinical and psychosocial outcomes related to care~     of the child with cleft lip and/or palate (CL/P), compare its performance with those of other~     cleft centers, and identify opportunities for quality improvement.~   "
66021|NCT02702856|"~     Validate a non-DRE exosome gene expression test, with an NPV >/= 90% certainty, will exclude~     the presence of high gleason grade/ score (>/=7) prostate cancer in a prostate needle biopsy.~   "
66022|NCT02702843|"~     The Study is designed to compare the effectiveness of Near Infrared Fluorescence~     Cholangiography (NIFC) to standard white light imaging (WLI) in visualizing and identifying~     the main biliary and hepatic structures (Cystic Duct, Right Hepatic Duct, Common Hepatic~     Duct, Common Bile Duct, Cystic-CBD junction, Cystic-Gallbladder junction and any Accessory~     Ducts) during laparoscopic cholecystectomy. The aim is to demonstrate that NIFC performs~     better than standard white light (WLI) alone in visualizing and identifying~     extra-hepatobiliary structures (Cystic Duct, Right Hepatic Duct, Common Hepatic Duct, Common~     Bile Duct, Cystic-CBD junction, Cystic-Gallbladder junction, and any Accessory Ducts) before~     and after dissection during Laparoscopic Cholecystectomy (LC).~   "
66023|NCT02702830|"~     This pilot research trial studies magnetic resonance imaging (MRI) and cardio~     (heart)-pulmonary (lung) exercise testing in evaluating exercise intolerance in patients with~     stage I-III breast cancer after treatment with chemotherapy drugs called anthracyclines.~     Anthracyclines are related with heart problems, cardiac abnormalities, bone and muscle~     dysfunction. Patients with breast cancer who are exposed to anthracycline drugs may also~     experience progressive fatigue and exercise intolerance which may limit daily activities and~     is an important barrier for patients returning to work. Using MRI and cardio-pulmonary~     exercise testing (CPET) may help doctors understand the causes of fatigue and exercise~     intolerance in patients receiving anthracycline chemotherapy and this may also allow doctors~     to plan better treatments to protect patients' heart, cardiovascular system, bone and muscle~     function.~   "
66024|NCT02702817|"~     Two-year double-masked trial of over-the-counter dosage of naproxen sodium vs placebo in 200~     cognitively normal participants with a parental or multiplex first-degree family history~     Alzheimer's disease (AD) dementia. Primary outcomes are decline in cognitive function and~     slope of change in a summary Alzheimer Progression Score derived from serial assessment of~     neuroimaging, biochemical, and sensori-neural biomarker indicators of pre-clinical disease --~     all believed likely to reflect progress of preclinical AD in this high risk cohort.~     Approximately 2/3 of participants have volunteered also for serial lumbar punctures for~     analysis of cerebrospinal fluid. A two-year off-treatment delayed-washout phase is planned to~     examine sustained treatment effects and evidence of disease modification.~   "
66025|NCT02702804|"~     Exercise has been shown to improve quality of life in people with multiple sclerosis but most~     exercise programmes are carried out at low to moderate intensities. The next stage in the~     management of the condition is to establish if people with mild Multiple Sclerosis can~     exercise, safely and effectively at a higher intensity. High intensity interval training~     (HIIT) involves repeated bursts of hard exercise interspersed with periods of rest. High~     intensity interval trainingcould be a time efficient and safe option for people with Multiple~     Sclerosis. Potential improvements are; cardiovascular fitness, resistance to fatigue,~     balance, quality of life and attitude to physical exercise.~      Participants will attend two sessions per week for 6 weeks. Each session will involve 6-10~     sets of 60 seconds of high intensity cycling followed by 60 seconds rest. Potential~     participants must have a clinical diagnosis of Mulitple Sclerosis for more than 3 months, an~     EDSS score of less than 2.5, aged 18-65, and had no more than one relapse in the last 2~     years.~      From this study the investigators hope to discover if High Intensity Interval Training is a~     safe and enjoyable form of physical activity for people with mild Multiple Sclerosis. This~     will then hopefully lead to further large research trials.~   "
66026|NCT02702791|"~     This randomized control trial will investigate whether the implementation of a telecoaching~     program, initiated during pulmonary rehabilitation, is able to increase and maintain physical~     activity and general benefits until six months after rehabilitation discharge.~      After three months of pulmonary rehabilitation (3 times a week), patients with COPD will be~     randomized to either an intervention group which receives an additional telecoaching program~     on top of the pulmonary rehabilitation, or to the usual care group, which only receives~     rehabilitation program. Apart from the added telecoaching program to the intervention group,~     the rehabilitation program will be identical and last for another three months (2 times a~     week). After discharge, both groups will be followed up for six months.~   "
66027|NCT02702778|"~     A four-week, randomized, controlled, open-label trial of DR prednisone in which patients~     receive in period 1 one of three-night time doses of treatment (4mg, 7mg or 10mg) for two~     weeks followed in period 2 by treatment with 15mg IR prednisone in the morning for two weeks.~     Period 1 is randomized and open-label and period 2 is open label. Before enrollment and~     randomization patient diagnosis and responsiveness to 15mg IR prednisone in the morning is~     established. 45 patients will be randomized, 15 patients in each treatment arm.~   "
66028|NCT02702765|"~     The aim is to investigate macrophage activation markers and correlations to liver fibrosis in~     patients with Wilsons Disease. Researchers wish to investigate associations to neurologic and~     metabolic liver function. Researchers will assess this by comparing blood samples with~     fibrosis and liver function analyses. This study provides new insight into macrophages and~     their involvement in Wilsons Disease.~   "
66029|NCT02702752|"~     The aims of the present study are to measure dynamic changes over time in the plasma level of~     SDF-1α in patients with confirmed diagnoses of AMI, AF and CHF and in so doing:~        1. Monitor the plasma level of SDF-1α at the diagnosis, during and after the long term~          treatment of AMI, AF and CHF. The SDF-1α level of patients is expected to decrease~          during treatment of the aforementioned conditions.~        2. Correlate the plasma level of SDF-1α in relation to clinical, biochemical~          characteristics of Acute Myocardial Infarction(AMI), Atrial Fibrillation(AF) and~          Congestive Heart Failure (CHF). In so doing, the investigators expect that SDF-1α will~          correlate with the severity of heart disease.~        3. Study the dynamic of SDF-1α pertaining to its property as prognostic indicator for the~          long term follow up risk of readmission and mortality of patients diagnosed with AMI, AF~          or CHF.~   "
66030|NCT02702739|"~     The proportion of HCV infected patients over age 65 years in Western countries is increasing.~     This growth and the advent of new antiviral therapy bring into the question the real world~     efficacy and safety of the combination of Sofosbuvir and Simeprevir (SOF/SMV) plus a flat~     dose of ribavirin (RBV) in elderly patients compared to younger patients.~   "
66031|NCT02702726|"~     The aim of this study is to compare the effects of dietary fats, ingested in two physical~     forms, on acute energy balance, appetitive, and glycemic responses of healthy normal (BMI~     18-24.9 kgm-2) or overweight (BMI>25kgm-2) adults.~   "
66032|NCT02702713|"~     This is a multi-centre, randomised, double-blind, placebo-controlled, parallel-arm dietary~     intervention study. In total, 800 men and women at risk for Metabolic Syndrome (MS) will be~     recruited. Subjects will be eligible to the study if they present with two to four of the MS~     diagnostic criteria, at least one of them being:~        -  fasting triglycerides ≥150 mg/dL but ≤400 mg/dL OR~        -  HDL-cholesterol ≤50 mg/mL in women, ≤ 40mg/mL in men (with fasting triglycerides ≥110~          mg/dL).~      Each of the four recruiting centres will recruit 200 volunteers. Participants will be~     randomly assigned to one of four groups to receive either:~        -  Dairy BEF + egg placebo + bakery placebo~        -  Egg BEF + dairy placebo + bakery placebo~        -  Bakery BEF + dairy placebo + egg placebo~        -  Dairy, egg and bakery placebo~      Participants will be required to consume all three of the allocated products each day for 12~     weeks.~      Eligible volunteers will be included and randomly allocated to one of the four groups. At~     baseline, 6 weeks and 12 weeks after inclusion, each participant will visit the recruiting~     centre for clinical and biochemical investigations. At 3 weeks and 9 weeks participants will~     complete questionnaires relating to their satisfaction with the food products, compliance to~     consumption of the study food products, and any gastrointestinal side effects or~     health-related adverse events that have occurred in the previous 3 weeks.~      At each recruiting centre 40 participants will be required to take part in additional~     activities, these are: stool sample collection, adipose tissue aspiration, body composition~     analysis by dual energy x-ray absorptiometry (DEXA) and assessment of physical activity.~   "
66033|NCT02702700|"~     This clinical study aims to explore intrapleural low-dose Visudyne®-mediated photodynamic~     therapy (photo-induction) as a pathway to promote the uptake of systemically administered~     Lipoplatin™ in pleural malignancies of patients undergoing video-assisted talcage for their~     malignant pleural effusions. Photo-induction is expected to overcome the chemo-resistance of~     pleural malignancies for cisplatin-based chemotherapeutics and thereby improve local tumor~     control.~   "
66034|NCT02702687|"~     This randomized controlled trial will include Latino and Black adolescents with asthma ages~     10-17 years old and their caregivers. Participants will be recruited from clinics in the~     Bronx, NY. The primary aims are to examine the efficacy of peak expiratory flow (PEF)~     prediction with feedback versus control feedback on 1) under-perception of asthma symptoms 2)~     controller medication adherence and 3) asthma control and emergency health care use. These~     aims will be examined across a 1-year follow-up. An exploratory aim examines the hypothesized~     pathway that the PEF intervention reduces under-perception of symptoms, shifts illness~     representations toward the professional model and increases adolescents' and parents' asthma~     management self-efficacy, resulting in greater medication adherence and improved asthma~     control.~   "
66035|NCT02702674|"~     The effect of coadministration of oral propranolol to oxytocin on induction of labor.~   "
66036|NCT02702661|"~     A prospective randomised controlled trial involving patients undergoing hip arthroscopy.~     Participants were randomised to receiving either Fascia Iliaca Compartment Block (FICB) or~     Local Anaesthetic Infiltration (LAI) of the portal tracts with local anaesthetic.~     Supplemental analgesia was also used in both groups on an on-demand basis. Pain level is~     assessed at 1,3,6, and 24 hours post surgery. The primary outcome measure was the~     post-operative level of pain as assessed by Numeric Pain Score 6 hours after surgery.~     Secondary outcome measures were the frequency and the dose of morphine and other medications~     consumed at 1 and 24 hours after surgery as well as any other adverse events relating to pain~     or medications used for pain relief in both the groups.~   "
66037|NCT02702648|"~     The primary purpose of this first-in-man study is to investigate whether a new drug for~     neurological disorders is safe and well-tolerated when administered orally to healthy adults~   "
66038|NCT02702635|"~     Dynamic contrast-enhanced (DCE) MRI gives quantitative and semi-quantitative information~     about the integrity of the vascular system and can be used to quantify blood-brain barrier~     (BBB) integrity. The BBB plays a pathophysiological role in diabetes, cognitive disorders~     such as mild cognitive impairment, Alzheimer's disease, multiple sclerosis, and chronic~     traumatic encephalopathy. Although dysfunctional, changes in BBB integrity for these~     conditions are thought to be subtle and close to intact values. Recent studies have shown it~     is possible measure small changes in the BBB integrity as an early sign of disease using DCE~     MRI. The objective of this study is to apply an optimized DCE imaging protocol and novel~     image post-processing to obtain new information about the BBB integrity in trauma. These~     techniques show promise for both improving clinical diagnosis, and elucidated the physiology~     or various disease processes.~   "
66039|NCT02702622|"~     The objective will be to quantify the vitamin A equivalence of the provitamin A in transgenic~     biofortified bananas.~   "
66040|NCT02702609|"~     Randomized Controlled study to compare the effectiveness of two different treatment~     approaches using a new moldable beta-tricalcium phosphate(TCP) bone graft material in ridge~     preservation of an atraumatic extraction socket site compared to allograft with collagen~     plug.~   "
66041|NCT02702596|"~     The proposed study seeks to establish the feasibility of universal screening for depression~     in an adult primary care safety net setting, measure the effectiveness of a culturally~     appropriate depression education intervention to reduce stigma and increase uptake in~     depression treatment among Hispanics, and implement a Measurement-Based Integrated Care~     (MBIC) model with collaborative, multi-disciplinary treatment and culturally tailored care~     management strategies.~   "
66102|NCT02701803|"~     In this study the aim is to evaluate the outcome of deep brain stimulation (DBS) and~     continuous intraduodenal levodopa therapy in patients with advanced Parkinson' disease by~     using Parkinson's KinetiGraph™ device which is a movement and acceleration measuring device.~     In this study we also evaluate the usability of Parkinson's KinetiGraph™ device by comparing~     it with written patient diaries.~   "
66042|NCT02702583|"~     Febrile neutropenia (FN) is a clinically important adverse effect of myelosuppressive~     chemotherapy. If patients present with FN, attention is focussed on well-recognized sites of~     origin of infection: the airways, urinary tracts, and skin. However, infections can be only~     documented clinically in about two-third of febrile episodes, whereas a causative microbial~     pathogen cannot be identified in the majority (>70%) of cases.~      Pre-treatment oral evaluation aimed to identify and eliminate oral/dental foci is only~     routinely used in patients at high risk for oral complications (i.e. head and neck cancer~     patients and stem cell transplantation recipients). However, any patient treated with~     myelosuppressive chemotherapy, be it for cure or palliation, is at risk of developing~     infection in and/or originating from the oral cavity. Nevertheless, in these patients dental~     screening is somewhat randomly employed at the oncologist's discretion.~      More insight into the pre-treatment oral condition and its potential role in FN is mandatory,~     particularly considering the growing numbers of older patients retaining their natural~     dentition and the increase of dental diseases and cancer incidence with age.~      In addition, oral diseases may aggravate chemotherapy-induced oral mucositis (OM). OM is~     associated with an inflammatory response, which together with ulcerations providing a portal~     of entry for bacteria, can result in FN and systemic inflammatory syndrome (SIRS) and/or~     sepsis. Evidence suggests that microorganisms are involved in the pathobiology of OM, but no~     longitudinal studies using open-end sequencing are available.~      Furthermore, comparing bacteria identified in blood cultures in febrile patients with those~     of the oral cavity will expand the knowledge on the role of the oral cavity as a potential~     source of bacteremia.~      The investigators expect that the results will provide a scientific base for subsequent~     intervention studies on the efficacy of dental screening and elimination of foci, and other~     interventions aimed at modifying the oral environment before and during chemotherapy.~   "
66043|NCT02702570|"~     The investigators are planning to recruit approximately 30 study participants aged 50 years~     and older that will undergo a 4 week attention and emotion regulation intervention. The~     intervention systematically targets thoughts, emotions and behavior in order to promote~     quality of life and advance successful brain aging. The investigators will assess the~     feasibility of recruiting and retaining participants for an attention and emotion regulation~     intervention. In addition, the investigators will determine the efficacy of the intervention~     to enhance and promote quality of life, sustained attention, emotions, motivation and~     cognitive health.~   "
66044|NCT02702557|"~     This feasibility study investigates if frail elderly and hospitalized patients are able to~     perform unsupervised elastic band exercises as a supplement to their usual supervised~     physiotherapy sessions and how much training they perform during their hospitalization. It is~     also investigated how the frail elderly and the health personnel experiences the unsupervised~     elastic band exercises.~   "
66045|NCT02702544|"~     Changes in volumetric hemodynamic parameters and fluid overload (Cardiac Index,Stroke Volume,~     Thoracic Fluid Content, Systemic Vascular Resistance) were measured using a impedance~     cardiography (ICG) (CardioScreen 1000 - Haemodynamic Measurement System, Medis. GmbH Ilmenau)~     while lifting the leg at different angles. The measurement lasted 12 minutes.~   "
66046|NCT02702531|"~     Endoscopic surgical procedures are becoming more common in all surgical specialties including~     gynecology that was one of the pioneers in this field specialties.~      Maintaining a quality field of view is important not only to patient safety but also for the~     quality of surgery and reduced surgery time.~      The lenses of vision which are located at the distal end of the optical vision are during~     endoscopic surgery in direct contact with the anatomical structures. These lenses are found~     soiled by several phenomena whose appearance of a mist which constitutes a major obstacle to~     a clear field.~      The alteration of the vision requires the surgeon extraction optics in order to achieve a~     cleaning of the lens. This cleaning is carried out as many times as necessary. Many~     strategies have been developed to improve the quality of vision. These methods relate to both~     the development of new optical vision but also the development of the lens cleaning material.~     In practice, the cleaning is carried out using a sterile swab sterile saline associated with~     the betadine iodine.~      Recently a new material called FloShield Air System Vision System has been proposed and has~     the particularity to combine both anti-fog product and a temperature control system in~     contact with the lens in order to fight against condensation and smoke. The purpose of this~     is to improve the quality of vision by reducing the fogging phenomenon and no change of the~     temperature in contact with the lens (moisture reduction). Accordingly, it is assumed a~     reduction in the number of stay and a reduction in the specific operative time associated~     with this cleaning.~      In this context, we wish to evaluate the effectiveness of FloShield Air System vision system~     on the basis of a comparative, prospective, randomized against the reference method (sterile~     water solution + Betadine) during endoscopic surgery gynecology.~   "
66047|NCT02702518|"~     The purpose of this study is to evaluate the tolerability and preliminary efficacy of rhDNase~     I eye drops in patients with ocular Graft-vs.-Host disease (oGVHD).~   "
66048|NCT02702505|"~     Mineral trioxide aggregate has been previously FDA approved as an endodontic filler. Its use~     in vital teeth has demonstrated significant color change post-treatment leaving it~     ineffective for esthetic use..~      The new formulation will be tested to see if has the same effect.~   "
66049|NCT02702492|"~     This study will evaluate the safety, tolerability, and efficacy of oral KPT-9274 for the~     treatment of patients with advanced solid malignancies or non-Hodgkin's lymphoma (NHL).~   "
66050|NCT02702479|"~     The rise in high fructose corn syrup (HFCS) consumption over the past 40 years since its~     introduction as a popular sweetener in the United States has led to much concern regarding~     its contribution to the rise in obesity (1), diabetes (2) and related cardiometabolic~     disorders (3).Unlike sucrose which contains equal proportions of fructose and glucose bound~     by an α-glycosidic bond, HFCS contains 42-55% of fructose to glucose in a free (unbound) form~     (4). Despite these differences in composition, both sugars possess identical energy~     contribution on a gram to gram basis (4). However, the higher ratio of fructose to glucose in~     HFCS has led to the hypothesis that HFCS may uniquely contribute to cardiometabolic risk,~     more so than sucrose, through proposed differences in fructose metabolism, endocrine and~     hedonic properties (5). We will conduct a series of systematic reviews and meta-analyses to~     assess the role of HFCS versus sucrose under energy matched (isocaloric) conditions on~     cardiometabolic risk.~   "
66051|NCT02702466|"~     The main objective of this work is to demonstrate superiority to three months of a~     standardized short course of SPA Therapy of 6 days associated with personalized health~     education program compared to conventional therapy in the management of MSDs on the~     functional capabilities of the employees in their daily lives (personal or professional)~   "
66103|NCT02701777|"~     The overall goal is to develop new clinical approaches to restore upper-limb function after~     incomplete cervical spinal cord injury (SCI). Corticospinal tract (CST) axons are involved in~     controlling upper-limb function. Paired pulse induced spike-timing dependent plasticity~     (STDP) enhances synaptic strength between residual CST axons and spinal motoneurons (SMNs)~     resulting in temporary improvements in upper-limb function in humans with incomplete cervical~     SCI. Motor training will be combined with paired-pulse STDP stimulation to further enhance~     plasticity and behavioral recovery.~   "
66104|NCT02701764|"~     Can Lyrica (Pregabalin) help prevent severe Dry Eye post LASIK surgery?~   "
67752|NCT02680106|"~     Evaluation of safety and performance of the SPINNER device and wound dressing in the~     treatment of donor-site wounds (DSW)~   "
66052|NCT02702453|"~     There is increasing evidence that sexual activity is associated with greater resilience and~     higher well-being in older adults. Even at a time of stress, and even during a late stage of~     illness, men and their partners turn to sexual intimacy to increase a sense of connection,~     comfort and support. The Sexual Recovery intervention seeks to address an unmet need of~     prostate cancer survivors and their partners who are at risk for poor mental health and~     decreased quality of life as a result of sexual dysfunction.~      By using technology, the intervention will be widely accessible to survivors, the majority of~     whom do not currently have any access to sexual health expertise. The content and format of~     the intervention seeks to empower prostate cancer survivors and partners with knowledge and~     strategies to improve their sexual function, sexual confidence and their sexual relationship.~     The intervention begins prior to and continues following their definitive treatment. This~     may, in turn, improve mental health and quality of life.~      In a broader sense, this intervention will be transferable. With appropriate modifications,~     it can become an accessible sexual health intervention for populations dealing with other~     cancers and chronic illnesses.~   "
66053|NCT02702440|"~     Consumption of sugar-sweetened beverages (SSBs) has been linked to rising rates of overweight~     and obesity. The most prominent mechanism to explain the link between SSBs and obesity is~     that liquid calories are not perceived by the body; thereby, promoting less satiety, less~     energy compensation and more weight gain than does the same energy consumed in solid form.~     This view is supported by pooled analyses of acute preload trials that have primarily~     measured food intake as the outcome. Though failure of short-term compensation has been~     observed with liquid calories, results from these acute preload trials should not be~     extrapolated to infer that liquid energy sources lead to weight gain over the long-term. To~     date, it is unclear whether liquid calories have differential effects than solid calories on~     body weight gain over the longer term. To increase clarity in this issue, the investigators~     propose to conduct a systematic review and meta-analysis from long-term controlled feeding~     trials to distinguish the contribution of liquid calories from solid calories on body weight~     over the long-term. The findings generated by this analysis will improve the health of~     consumers through informing evidence-based guidelines and improving health outcomes by~     educating healthcare providers and patients, stimulating industry innovation, and guiding~     future research design.~   "
66054|NCT02702427|"~     Invasive infections with CMV and Adenovirus, not responding to virostatic treatment are~     treated with virusspecific donor derived or autologous virusspecific T-cells.~   "
66055|NCT02702414|"~     This is a efficacy and safety study of pembrolizumab (MK-3475, KEYTRUDA®) as monotherapy in~     participants with previously systemically treated hepatocellular carcinoma (HCC). Study~     participants may receive pembrolizumab once every 3 weeks for up to 35 administrations (up to~     approximately 2 years).~      The primary objective of this study is to determine the Objective Response Rate (ORR) of~     pembrolizumab given as monotherapy in participants with previously systemically treated HCC~   "
66056|NCT02702401|"~     This is a study of pembrolizumab (MK-3475) in participants with previously systemically~     treated advanced hepatocellular carcinoma (HCC).~      The primary objectives of this study are to determine 1) Progression-Free Survival (PFS) and~     2) Overall Survival (OS) of pembrolizumab plus best supportive care (BSC) compared with~     placebo plus BSC. The primary hypotheses of this study are: 1) pembrolizumab plus BSC~     prolongs PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, assessed by a~     blinded central imaging vendor compared to placebo plus BSC, and 2) pembrolizumab plus BSC~     improves OS compared with placebo plus BSC.~   "
66057|NCT02702388|"~     This is a multicenter, randomized, double-blind study being conducted as a postmarketing~     requirement to the US Food and Drug Administration (FDA) to evaluate whether there is a lower~     starting dosage of lenvatinib 24 mg once daily (QD) that provides comparable efficacy but has~     a better safety profile in participants with radioiodine-refractory differentiated thyroid~     cancer RR-DTC with radiographic evidence of disease progression within the prior 12 months.~   "
66058|NCT02702375|"~     There is an urgent need for stronger evidence to support recommendations for the role of~     sugars in diabetes and related cardiometabolic diseases. Although large prospective cohort~     studies have shown a significant positive association of fructose-containing sugars-sweetened~     beverages with incident obesity, diabetes, heart disease, and stroke, these associations do~     not appear to hold true for total fructose-containing sugars and other important sources of~     free fructose-containing sugars such as pure fruit juice, yogurt, or even cakes and sweets.~     As dietary guidelines have moved away from macronutrient centric recommendations towards more~     food and dietary-pattern based recommendations, this inconsistency in the data has not been~     appreciated. There remains a focus on free sugars, in the absence of sufficient information~     on the role of different food sources of fructose-containing sugars in diabetes and related~     cardiometabolic diseases. A systematic review and meta-analysis of prospective cohort studies~     is considered to be the Gold Standard of evidence. To provide evidence-based guidance to~     support the development of public health policy in relation sugars and the primary prevention~     of diabetes, we will conduct a series of systematic reviews and meta-analyses of the relation~     of food sources of fructose-containing sugars with incident type 2 diabetes and related~     cardiometabolic diseases in prospective cohort studies.~   "
66059|NCT02702362|"~     In this study researchers will apply transcranial direct current stimulation (tDCS) for 5~     consecutive days in chronic patients in minimally conscious state (MCS).~   "
66060|NCT02702349|"~     The incidence of reactions during penicillin challenge tests among children with suspected~     penicillin allergy~   "
66105|NCT02701751|"~     The primary purpose of this study is to examine the effects of chronic exercise training and~     an acute session of exercise on key risk factors associated with Metabolic Syndrome (e.g.,~     glucose tolerance, blood lipid profile, and blood pressure) and alterations in subcutaneous~     adipose tissue structure and metabolic function in overweight adults.~   "
66106|NCT02701738|"~     The primary purpose of this study is to examine the effects of 1-week of overeating on~     important clinical metabolic health outcomes (e.g., glucose tolerance, blood lipid profile,~     and blood pressure) and factors regulating the structure and metabolic function of fat~     tissue. This study will determine how regular exercise during this overeating period impacts~     these responses.~   "
83614|NCT02472522|"~     Comparative study of Ropivacaine and Ropivacaine with dexmedetomidine in transversus~     abdominis plane (TAP) block for post-operative analgesia in patients undergoing Caesarean~     Section.~   "
66061|NCT02702336|"~     The primary aim is to promote healthy lifestyles among young people, through the design and~     implementation of health promotion activities carried out by adolescents (12-14 years old) to~     scholars of primary education (8-10 years old), using social marketing and peer-led strategy.~      The secondary aims are: 1) to increase fruit and vegetable consumption and physical activity~     practice in scholars and adolescents; 2) to reduce sedentary lifestyles, sugary drinks and~     fast-food in scholars and adolescents.~      The EYTO-kids program is a randomized, parallel, intervention program with control group,~     with a 2 academic courses, 2015-2016 to 2016-2017 (10 months in total), in Reus (Spain).~      To achieve the aims, social marketing and peer-led methodologies will be used at the~     intervention design and implementation. Adolescents from secondary education (1st /2nd ESO:~     Educación Secundaria Obligatoria-Obligatory Secondary Education) will design and implement~     activities to scholars from primary education (3rd/4th primary education).~      The adolescents from the intervention group will design and implement activities to implement~     them in to children, and the control group will not receive any kind of intervention (only~     the assessment).~      Participation will occur according to the randomized sample size, where a minimum of 208~     adolescents (104 as intervention and 104 as control group), and 602 scholars (301 as~     intervention and 301 as control group) will be involved.~      The inclusion criteria are: to have signed informed consent (from mother/father/guardian of~     the participant), to provide basic demographic data, to assist participating schools and to~     answer a lifestyle questionnaire.~   "
66062|NCT02702323|"~     This study mainly evaluate the clinical effect of Apatinib in the treatment of patients with~     pulmonary metastasis of hepatocellular carcinoma.Half of participants will receive Apatinib~     and transcatheter arterial chemoembolization (TACE) therapy in combination,while the other~     half will receive TACE therapy alone.~   "
66063|NCT02702310|"~     This clinical trial studies low- dose total skin electron therapy in treating patients with~     stage IB-IIIA mycosis fungoides that has not responded to previous treatment (refractory) or~     has returned after a period of improvement (relapsed). Radiation therapy uses high energy~     electrons to kill tumor cells and shrink tumors. Rotisserie technique is a method in which~     the patient receives total skin electron therapy while standing on a rotating platform.~     Giving low dose total skin electron therapy using rotisserie technique may kill tumor cells,~     while having fewer side effects, and may allow therapy to be repeated in future if clinically~     indicated.~   "
66064|NCT02702297|"~     The purpose of this study is to examine whether the value of vaginal fluid cytokine levels as~     well as computerized fetal ECG analysis are suitable clinical parameters to detect an~     imminent intra-amniotic inflammation with a high risk of fetal inflammatory response syndrome~     (FIRS) or a neonatal early onset sepsis (EOS) and whether these parameters can be determined~     on a daily basis in the clinical monitoring of pregnancies complicated by PPROM.~   "
66065|NCT02702284|"~     The ability to communicate with patients is profoundly impacted by their health literacy -~     the ability to interpret documents, read and write prose, use quantitative information and~     speak and listen effectively. Limited health literacy is commonplace and associated with~     multiple poor health outcomes including frequent readmission's and high mortality. Advance~     directives are an important tool in respecting patient autonomy in health care interventions.~     Advance directives can also reduce health care costs by avoiding unwanted, unnecessary care~     at the end of life. At the University of Florida (UF) Health currently an initiative is~     underway to improve the delivery of advance directives to patients in the hospital as well as~     the outpatient clinics.~      The aim of this research study is to enhance completion rates of advance directives by taking~     into consideration a patient's health literacy level. Specifically, the investigators plan to~     assess the impact of an ambulatory intervention on the completion rate of advance directives~     for patients with adequate and limited health literacy. The hypothesis is that both groups~     (adequate and limited health literacy) will benefit from the intervention, but patients with~     limited health literacy will show a greater improvement in the advance directives completion~     rate.~   "
66066|NCT02702271|"~     The study is a prospective, non-randomized, multi-center investigation to establish the~     safety and effectiveness of the WATCHMAN FLX™ Left Atrial Appendage Closure Device for~     subjects with non-valvular atrial fibrillation who are eligible for long-term~     anti-coagulation therapy to reduce the risk of stroke but who have a rationale to seek a~     non-pharmacologic alternative.~   "
66067|NCT02702258|"~     Specific aims are:~        1. To outline and evaluate key active elements of the Mindfulness-Based Blood Pressure~          Reduction (MB-BP) intervention. This aim will be achieved using (a) focus groups of~          participants undergoing the MB-BP intervention, (b) discussion with experts (including~          cardiologists, epidemiologists, mindfulness experts, mindfulness intervention~          instructors) prior to, and following pilot testing of MBHT in participants, and (c)~          clinical judgment of the investigators performing the intervention.~        2. To evaluate impacts of MB-BP on target engagement (pre-post change in effect size) and~          longevity of target engagement (follow-up time-points). Follow-up time periods include~          10 weeks, 6 months and 1 year.~      This study is a prospective single-arm trial during the intervention development phase.~     Following this phase, after the intervention has been further developed, a subsequent study~     (with a different clinicaltrials.gov ID #) will utilize a randomized control trial design to~     further evaluate causation and effect size.~   "
66068|NCT02702245|"~     This cross-over intervention study aims to investigate the effect of two doses of thylakoids~     to an oral glucose tolerance test (OGTT) on glucose and insulin homeostasis as well as~     appetite regulating hormones in healthy volunteers.~   "
66069|NCT02702232|"~     Parkinson's disease (PD) is a multisystem neurodegenerative disorder that is increasingly~     recognized in our ageing population. It is characterized by cardinal clinical features~     including bradykinesia, tremor, rigidity, and postural instability. For most people with PD,~     the most serious concern is with the motor system: stiffness, slowness of movement, impaired~     handwriting and coordination, poor mobility and balance. However, more than half of all~     people with PD have experienced painful symptoms. Most people experience aching, stiffness,~     numbness and tingling at some point in the course of the illness. Defazio et al reported that~     pain may begin at clinical onset of PD or thereafter as a non-motor feature of PD.5 Aching~     muscles and joints are especially common in PD. Rigidity, lack of spontaneous movement,~     abnormalities of posture and awkward mechanical stresses all contribute to musculoskeletal~     pain in PD.~   "
66070|NCT02702219|"~     Mobility training in the form of stretching and flexibility training of our skeletal muscle~     is a common exercise. However, the evidence are scare and there are only a few studies~     comparing the effect of prolonged static stretching (> 90 sec) and dynamic flexibility~     training as to which of these methods has the best length-enhancing effect over time.~     Further, in clinical practice concerning low back pain, the possibility of a thigh hamstrings~     muscles to affect movement control of the spine is often mentioned, a link not fully explored~     in a controlled condition. The purpose of this study is to compare the effect of eight weeks~     of dynamic flexibility training versus prolonged static stretching on mobility in the~     hamstring muscles in adults with reduced mobility in the muscles at the back of the thigh.~     The aim is also to compare the sustained effect of flexibility training between the two~     groups, eight weeks after completion of the intervention. Furthermore, the aim is to explore~     how different forms of flexibility training affects movement patterns of the lumbar spine in~     adult persons with reduced mobility in the hamstrings.~   "
66071|NCT02702206|"~     A randomized controlled trial to compare the effect of ultrasound-guided hyaluronic or~     corticosteroid injections in patients with chronic subacromial bursitis.~   "
66072|NCT02702193|"~     The study conducts a community-based randomized trial comparing an adaptation of Structural~     Ecosystems Therapy (SET), Healthy Home, as an enhancement of substance abuse or mental~     health outpatient treatment, to outpatient treatment as usual (TAU) among approximately 172~     Black, Hispanic and White nonHispanic mothers enrolled in outpatient substance abuse or~     mental health services. The study is conducted with a community partner, Banyan Health~     Systems, that delivers substance abuse/mental health treatment and primary care. Data is~     collected at baseline and 4, 8, and 12 months postrandomization. The Specific Aims of the~     proposed study are to: 1) test the effectiveness of Healthy Home for improving physical and~     mental health and reducing relapse of mothers in substance abuse/mental health recovery; 2)~     test the effectiveness of Healthy Home for improving health and mental health outcomes of~     children of mothers in recovery; 3) test mechanisms of action of Healthy Home (self care,~     environmental risk, family functioning and stigma); 4) assess implementation and~     sustainability factors and the relationship between fidelity and outcomes; and 5) examine the~     interactions of ethnicity and ethnicity related factors on outcomes. Healthy Home is a~     manualized, strength-based, directive and process oriented family ecosystemic home health~     intervention developed to address the needs of mothers and their children affected by~     substance abuse and other mental health disorders.~   "
66073|NCT02702180|"~     This study evaluates inhaled molgramostim (recombinant human (rh) Granulocyte~     Macrophage-Colony Stimulating Factor (GM-CSF)) in the treatment of autoimmune pulmonary~     alveolar proteinosis patients. A third of the patients will receive inhaled molgramostim~     daily for 24 weeks, a third will receive inhaled molgramostim intermittently (seven days on,~     seven days off) for 24 weeks and a third will receive inhaled matching placebo for 24 weeks.~   "
66074|NCT02702167|"~     This trial will compare the efficacy and tolerability of 10 Hz vs. 1 Hz vs. sham repetitive~     transcranial magnetic stimulation targeting the dorsomedial prefrontal cortex, delivered once~     daily over 30 days, in patients with a diagnosis of bulimia or anorexia nervosa binge-purge~     subtype. The trial will include structural and functional MRI, and behavioral measures~     obtained before, during, and after treatment.~   "
66075|NCT02702154|"~     This trial will compare the efficacy and tolerability of 20 Hz vs. 1 Hz vs. sham repetitive~     transcranial magnetic stimulation targeting the dorsomedial prefrontal cortex, delivered~     twice daily over 15 days, in patients with a diagnosis of major depressive disorder. The~     trial will include structural and functional MRI, EEG, and behavioral measures obtained~     before, during, and after treatment.~   "
66076|NCT02702141|"~     The study will examine the safety profile of SGN-CD19B administered as a single agent. The~     main purpose of the study is to estimate the highest dose that does not cause unacceptable~     side effects of SGN-CD19B in patients with relapsed or refractory aggressive B-cell~     non-Hodgkin lymphoma (NHL) subtypes of diffuse large B-cell lymphoma (DLBCL) and Grade 3~     follicular lymphoma (FL3). Additionally, the pharmacokinetic profile and antitumor activity~     of SGN-CD19B will be assessed.~   "
66077|NCT02702128|"~     Prospective, randomized, double-blind, placebo-controlled, mono center, Phase III trial to~     compare EXACYL in preventive with placebo on perioperatory bleeding in orthognathism surgery.~   "
66078|NCT02702115|"~     The purpose of the study is to evaluate the safety, tolerability of ascending doses of~     SB-318. SB-318 is an intravenously delivered Zinc Finger Nuclease (ZFN) Therapeutic for~     genome editing. It inserts a correct copy of the α-L-iduronidase (IDUA) gene into the Albumin~     locus in hepatocytes with the goal of lifelong therapeutic production of the IDUA enzyme.~   "
66079|NCT02702102|"~     This study uses a special type of scan called a positron emission tomography (PET) scan to~     take pictures of the brain. During the PET scan, a special dye called 11C-PBR28 is injected~     into the body.~      11C-PBR28 sticks to parts of the brain where there is inflammation. The purpose of this study~     is to see if 11C-PBR28 can detect inflammation in patients with Parkinson's disease dementia~     or dementia with Lewy bodies.~      11C-PBR28 is considered a drug by the Food and Drug Administration. 11C-PBR28 is not a~     treatment for any disease. Rather, 11C-PBR28 can be used to measure inflammation in the~     brain.~   "
66090|NCT02701959|"~     Leafy vegetables are a natural source of dietary nitrate, which may reduce systolic blood~     pressure (BP). However, the evidence has been obtained from studies using nitrate solutions~     (i.e., potassium or sodium nitrate) or beetroot juice supplementation which have a suitable~     placebo for the design of double-blind clinical trials. However, the design of food-based~     nutritional interventions is complicated by the fact that an appropriate placebo treatment is~     not available and, therefore, it is not possible to meet the criteria for proper double-blind~     randomised placebo-controlled intervention trials. In addition, the biological effects of~     processed products such as beetroot juice or solutions with a pharmacological grade may be~     different from that of fresh vegetables, e.g. due to conversion of nitrate to nitrite in the~     mouth during chewing.~      Objectives: to investigate whether two sets of lettuce specifically grown with different~     nitrate content but otherwise similar composition show different effects on nitrate uptake~     and bioavailability in humans. Additionally, the investigators also aim to design human~     intervention studies to investigate the effect of intake of lettuce with different nitrate~     content on vascular health.~      These objectives will be tested by growing lettuce with different fertiliser compositions~     resulting in high and low nitrate content and then investigating the bioavailability and~     short-term effect on BP in healthy young volunteers in a double-blind cross-over design.~     Eligible subjects will consume one meal each of either low or high nitrate lettuce. Urine,~     blood and saliva samples will be collected at baseline, for 6 hours after the ingestion and~     then again after 24hr. Blood Pressure BP will be measured continuously for 24 hours starting~     at baseline. The volunteers will repeat the intervention with the second treatment.~   "
66080|NCT02702089|"~     14,000 new cases of rectal cancer are diagnosed each year, frail and elderly patients~     represent a rising proportion of these patients. Whilst the gold standard is often to remove~     the tumour and restore bowel continuity, surgeons will often avoid this procedure in this~     group of patients as they unfortunately tolerate surgical complications very poorly. Such~     surgical complications may present with life threatening sepsis, can prolong hospital stay,~     delay further cancer therapy and in the elderly or frail patient often leads to loss of~     independence and quality of life. In this setting, there are two alternative procedures~     (Hartmann's procedure OR intersphincteric APE) that may be used and these are employed in~     roughly equal measure in the UK (nationwide survey, Dec 2013, unpublished data). It is~     anecdotally felt that Hartmann's procedure (HP) has a greater risk of surgical complications~     (30%) and a few small retrospective studies have shown this (1-3), however there are no~     prospective data to support this view. Whilst some surgeons do choose intersphincteric APE~     (IAPE) on the basis of a lower surgical complication rate, many do not due to perceived~     limitations in the technique (longer operating time, risk of tumour perforation), which are~     unproven. We feel that a larger, prospective dataset is required to demonstrate the~     superiority of IAPE over HP and convince the remaining surgeons to change procedure. We have~     explored the possibility of a full randomised trial to answer this question, however this is~     not feasible due to the difficulty of randomisation of patients. Very little data are~     available regarding the use of IAPE in the setting of rectal cancer, however many surgeons~     who do employ the technique, specifically adapt their technique in this setting to reduce the~     chances of tumour perforation (two stage, stapling off rectum before removing anal canal~     separately). It is possible that those surgeons who prefer HP have not considered this, and~     combined with the lack of prospective data are reluctant to change technique. We are~     confident that if we can demonstrate a significant difference in surgical complication rate~     and promote a modification to the IAPE surgical technique then we can significantly reduce~     surgical harm to these frail patients.~   "
66081|NCT02702076|"~     This randomised, double-blind, placebo-controlled trial will evaluate the efficacy of~     continuous apomorphine infusion compared to placebo in PD patients with visual~     hallucinations, inadequately controlled with clozapine and cholinesterase inhibitors.~   "
66082|NCT02702063|"~     Cardiac output (CO) is a key variable when describing the cardiovascular system. Electrical~     cardiometry (EC) is a non-invasive method in measuring stroke volume and cardiac output.~     However, its accuracy has been inconsistent. Therefore Martin et al. have compared~     measurements with echocardiographic measurements and propose calibration with left ventricle~     outflow tract (LVOT)-measurements obtained from transthoracic echocardiography (TTE). This~     study was performed in pregnant women at term. Goal of this study is to validate their~     formula in non-pregnant outpatients undergoing echocardiography for cardiology work-up.~     Secondary aim is to perform a leg raising test and to compare changes in stroke volume~     observed with either EC or TTE.~   "
66083|NCT02702050|"~     The purpose of this study is to investigate the efficacy of mechanical stimulation on~     mastectomy scars in:~      (i) alleviating scar appearance - pigmentation, vascularity, pliability and thickness, (ii)~     reducing shoulder morbidities, (iii) improving arm functions, and (iv) enhancing quality of~     life, in women with breast cancer after mastectomy.~   "
66084|NCT02702037|"~     The novelty with the OPEN study is to evaluate the effects of the simple sit-to-stand~     exercise during routine care, in combination with an oral protein-rich supplement, on~     functional status and independence in frail older persons. In this study we will also explore~     the experiences among older persons in the intervention group as wells as among staff of~     promoting the sit-to-stand exercise and nutritional supplement to gain knowledge for~     implementation as a daily routine in nursing homes across Sweden.~      Hypothesis The main hypothesis of the OPEN study is that physical exercise performed as a~     daily routine along with an oral protein-rich supplement, will result in improved functional~     status and independence in everyday life activities and thereby enhance health-related~     quality of life in older persons living in nursing homes. The primary outcome measure for~     functional status will be the number of sit-to-stands that the participant is able to~     complete in 30 seconds.~      Specific aims Aim I: To study the effects of the sit-to-stand exercise combined with an oral~     protein-rich supplement on functional and nutritional status, and health-related quality of~     life, and the frequency and incidence of falls, pressure ulcers and incontinence in older~     persons living in nursing homes. Furthermore, the cost effectiveness of the combination of~     the sit to stand exercise and oral protein-rich supplement vs. the control group will also be~     examined.~      Aim II: To describe the older persons' perceptions of daily being offered to conduct the~     sit-to-stand exercise and to drink the nutritional supplement.~      Aim III: To describe staff's perceptions of supporting the sit-to-stand exercise and the~     nutritional supplement with older persons living in nursing homes.~   "
66085|NCT02702024|"~     Placenta percreta is a life-threatening condition that patients are under risk of massive~     bleeding. It readily necessitates very complicated surgery even leads to mortality. Cesarean~     hysterectomy is the procedure that is acknowledged worldwide, however, recent studies~     discussing conservative treatment with segmental resections were published. Fetal extraction~     and segmental resection could be performed from same (single uterine incision) or two~     different (double uterine incision) incisions. In this study, the investigators aimed to~     evaluate the effectiveness and the results of double uterine incision.~   "
66086|NCT02702011|"~     To assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of once daily oral~     doses of empagliflozin in Japanese patients with type 1 diabetes mellitus as adjunctive~     therapy to insulin.~   "
66087|NCT02701998|"~     This study involves a randomized controlled trial to test the feasibility, acceptability, and~     efficacy of a mobile health (mHealth)-enhanced physical activity (PA) intervention to~     increase daily bout-related and total moderate-intensity PA and to reduce sedentary behavior~     (SB) in non-physically impaired patients with ischemic stroke or transient ischemic attack~     (TIA).~   "
66088|NCT02701985|"~     This is a randomized, double-blind, placebo-controlled, two-treatment arm, parallel-group~     study designed to evaluate the effects of RO5459072 treatment on disease activity and~     symptoms of Sjogren's syndrome in adult participants with moderate to severe primary~     Sjogren's syndrome. The total duration of the study for each participant will be~     approximately 18 weeks (including screening).~   "
66089|NCT02701972|"~     The preclinical and clinical evidence of safety and efficacy with the BACE device (concept~     and feasibility) paved the way for the evaluation of the BACE device in this prospective,~     multi-center, single-arm, self-controlled study for safety and efficacy in the treatment of~     functional MR in a maximum of 60 adult subjects.~      The primary efficacy endpoint will be reduction of MR grade to 1+ or less from the baseline~     MR grade through the 6 month study period. Primary safety endpoint will be freedom from major~     device and surgery-related adverse events for the duration of the 6 month follow up period.~     Patients will be followed up to two years.~   "
71091|NCT02636452|"~     In patients with Interstitial lung diseases (ILD) dyspnea is the most often symptom.~     Pulmonary lung function tests often do not Show the dyspnea. Aim of the study is to evaluate~     cardiopulmonary exercise testing concerning therapeutic Monitoring in ILD.~   "
66091|NCT02701946|"~     Total knee arthroplasty (TKA) is one of the most successful procedures in orthopaedic~     surgery. Nevertheless, significant postoperative blood loss and requirement of blood~     transfusion are still problematic. Total blood loss in TKA can be divided into visible and~     invisible blood loss. Visible blood loss (VBL) means blood loss from the surgical field and~     wound drainage while invisible blood loss (IBL) means residual blood in the knee,~     extravasation into the tissues and loss due to haemolysis.~      In usual practice, TKA is performed with a bloodless field using a tourniquet. Thus~     intraoperative blood loss can be negligible and postoperative drainage is only considered as~     VBLvisible. In terms of IBL, Sehat et al. found that TKA carried a substantial IBL. Their~     results shown the mean IBL was 765 ml or 49% of the mean total blood loss after TKA.~     Therefore, the true total blood loss was underestimated if not takes IBL into account.~      Modified Robert Jones bandage (MRJB) is a bulky compressive dressing that often used in~     orthopaedic practice. Various techniques of application have been proposed.~      From the previous study, MRJB could make and maintain the anterolateral muscle compartment~     pressure for at least 24 hours after TKA. Therefore, theoretically, this bandage can cause~     the tamponade effect that helps to reduce tissue edema and postoperative bleeding especially~     IBL after TKA. However this potential benefit of MRJB is unclear and the use of this bandage~     after TKA is still controversy in clinical practice.~   "
66092|NCT02701933|"~     In this study, the investigators examine the effects of low-dose ketamine on different~     oculomotor, perceptual and cognitive functions. They also examine effects on concurrent brain~     activity using blood oxygen level dependent (BOLD) functional magnetic resonance imaging~     (fMRI). A sample of N=25 healthy, male participants is required to complete the study. The~     design is within-subjects, placebo-controlled, double-blind and cross-over. A targeted~     ketamine level in plasma of 100ng/ml is applied. It is hypothesised that ketamine, compared~     to placebo, will lead to changes in task performance and brain activity similar to those~     observed in patients with schizophrenia.~   "
66093|NCT02701920|"~     This study will compare a newborn heart rate sensor (HeartLight) that is integrated into a~     hat with other common forms of heart rate monitoring such as electrocardiography (ECG),~     stethoscope and pulse oximetry (PO) in newborn babies. This will help to evaluate the new~     heart rate sensor's reliability and accuracy.~   "
66094|NCT02701907|"~     Adult patients with metastatic or locally advanced solid malignancies (including but not~     limited to breast, cancer, lung adenocarcinoma or squamous cell carcinoma, colorectal cancer,~     ovarian cancer, renal clear cell cancer, skin cutaneous melanoma), presenting or having~     presented an exceptional and unexpected response to an antineoplastic targeted therapy.~   "
66095|NCT02701894|"~     With the emerging worldwide epidemic of type 2 diabetes, dietary recommendations to improve~     diabetes management have been emphasized in the scientific community. Particular attention~     has been drawn to various benefits of replacing saturated fatty acids with unsaturated fatty~     acids. Alpha-linolenic acid, the only omega-3 fatty acid that is from plant sources, has been~     suggested by animal and cell studies to play a beneficial role in regulating blood glucose~     levels. However, human studies have been more inconsistent with their findings. The focus of~     this project is to investigate the evidence in the context of ALA and blood glucose~     parameters in participants with type 2 diabetes by conducting a systematic review and~     meta-analysis of randomized controlled trials.~   "
66096|NCT02701881|"~     -  Prospective, randomized, controlled, multi-center study~        -  A total of 220 subjects with long femoropopliteal lesions will be included according to~          inclusion and exclusion criteria.~        -  Patients will be randomized in a 1:1 manner into long stenting group versus short~          stenting group. and treated with Zilver PTX for long femoropopliteal lesions~        -  Patients will be followed clinically for 1 year after the procedure.~        -  Image study follow-up (Duplex US or CT angiography) will be performed at 1 year.~   "
66097|NCT02701868|"~     Although breast milk is recommended exclusively until 6 months of age, two-thirds of infants~     in the U.S. are fed infant formula. Despite an almost identical energy density between infant~     formula and breast milk, formula fed infants experience greater weight gain in the first year~     of life. The investigators propose that unintentional overfeeding, of nearly one additional~     day of calories per week, due to the over-scooping of powdered formula contributes~     significantly to this phenomenon and potentially to the early development of childhood~     obesity, a significant public health problem.~   "
66098|NCT02701855|"~     This study aims to determine the relationships between retina micro-vascular remodeling and~     cognitive function in hypertensive patients.~      The study plans to enrol 160 patients (100 patients with mild cognitive impairment -MCI- and~     60 without MCI).~   "
66099|NCT02701842|"~     The researchers want to find out more about a standalone software application, ImPACT Online~     and how it relates to other commonly used tests of memory, attention and reaction time.~     ImPACT Online is a computer-based neurocognitive test for concussion management. The test was~     designed to help measure the effects of concussion on cognitive processes (for example,~     memory, attention, brain speed) and visual functioning.~   "
66100|NCT02701829|"~     In our past work it was found that many drivers had high blood pressure, and lifestyles that~     led to being overweight and not having cancer screenings performed. The investigators are now~     adding to the Health Fairs' usual program different ways of following up with drivers who~     attend our Health Fairs. The investigators are doing this because they want to find the best~     way to help drivers manage high blood pressure, and reduce cancer risk, by maintaining a~     healthy weight and increasing colorectal cancer screening.~      * If critically abnormal values are identified during the health fair, under the advisement~     of the clinician, the driver may be escorted by trained staff directly to a health care~     facility for immediate medical follow-up~   "
66101|NCT02701816|"~     -  Prospective, single-arm, multi-center registry study~        -  A total of 150 subjects with femoropopliteal artery disease who meet all inclusion and~          exclusion criteria will be included.~        -  Patients will be followed clinically for 12 months after the procedure.~        -  Duplex ultrasound, CT or catheter-based angiography follow-up according to participating~          hospital's protocol will be performed at 12 months.~        -  Presence of stent fracture will be evaluated by plain radiography or fluoroscopy at 12~          months.~        -  Quality of life by standardized questionnaires (at baseline & at 1 & 12 months)~   "
83662|NCT02471898|"~     A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Two-Part Evaluation of the Efficacy~     and Safety of Locally Administered HTX-011 for Postoperative Analgesia Following Bunionectomy~   "
66107|NCT02701725|"~     The investigators will use the Compensatory Reserve Index (CRI) device to monitor hemodynamic~     status of patients in the hospital. CRI values of patients will be monitored during their~     care in order to verify the compliance of the values to the physiological condition. During~     the protocol investigators will document patients injuries, life-saving procedures performed,~     response to treatment as well progress to systemic inflammatory response syndrome (SIRS) and~     sepsis.~      The indices measured in the study will not be a consideration when handling patients. The~     medical team will not be exposed to metrics measured.~   "
66108|NCT02701712|"~     The aim of this study is to evaluate the technical performance of magnetic-resonance guided~     radiotherapy (MRgRT) facility at the Princess Margaret Cancer Centre and the impact on the~     workflow of the clinical team in this facility.~   "
66109|NCT02701699|"~     The purpose of this study is to look for low levels of oxygen (hypoxia) in lung cancer using~     a positron emission tomography (PET) scan. Hypoxia can influence how lung cancer grows and~     responds to treatments like radiotherapy and chemotherapy. The use of PET scans to measure~     hypoxia may be better and simpler than the approaches used previously. This study will assess~     whether or not PET scans can provide useful information about hypoxia in lung cancer.~      In this study, a radiotracer called Fluoroazomycin Arabinoside (FAZA) will be used to measure~     hypoxia in the patient's tumour. FAZA has already been used in many cancers including lung~     cancer. Patients who consent to participate in this trial will receive 1 FAZA PET Scan prior~     to their first radiotherapy treatment~   "
66110|NCT02701686|"~     The purpose of this study is to test the effectiveness of negotiating self determination to~     reduce cigarette consumption. A single-blinded multi-centre randomized controlled is~     employed.~   "
66111|NCT02701673|"~     The goal of this clinical research study is to find the highest tolerable dose of belinostat~     that can be given in combination with azacitidine, gemcitabine, busulfan, and melphalan to~     patients who are scheduled to have a stem cell transplant. If you have diffuse large B-cell~     lymphoma (DLBCL), you will also receive rituximab. Researchers also want to learn about the~     safety and effectiveness of this combination.~   "
66112|NCT02701660|"~     Electronic dispensers for polypharmacy are used in home care to assist patients with their~     medication management and to improve adherence. Opioid dependent patients with substitution~     therapy often exhibit multiple risk factors for non-adherence. The increase of both the age~     and associated comorbidities in this population demand for innovative solutions to optimize~     medication management. The investigators developed a novel medication supply model with an~     automated electronic medication dispenser to simultaneously assist opioid dependent patients~     with their medication and objectively monitor their adherence. This study aims to demonstrate~     the feasibility of the new supply model.~   "
66113|NCT02701647|"~     The Purpose of this study is to investigate whether the beneficial effect of treadmill~     training on people with Parkinson's disease can be enhanced by repetitive transcranial~     magnetic stimulation (rTMS).~   "
66114|NCT02701634|"~     This study will evaluate the effect of entospletinib on the best overall response rate in~     adults with chronic graft versus host disease (cGVHD) who are currently receiving systemic~     corticosteroids as first-line therapy for cGVHD.~   "
66115|NCT02701621|"~     The aim of this study is to compare the effectiveness of a specific aquatic therapy program~     on balance with a land-based physical-treatment in patients with Parkinson's disease and to~     evaluate the long-term effects in a 6-month follow-up period.~   "
66116|NCT02701608|"~     Infective endocarditis (IE) is a serious infection with a significant burden for patients and~     hospitals (in France, median length of hospital stay = 43 days), partly due to the long~     duration of intravenous (IV) antibacterial treatment recommended by international guidelines,~     between 4 and 6 weeks in most situations.~      A recent survey of practices regarding the management of IE in France showed that a switch~     from IV to oral antibiotics is feasible, when patients with left-sided Staphylococcus IE are~     stable after an initial course of IV antibiotic treatment, with or without valvular surgery.~      These practices have not been associated with unfavourable outcome, while significantly~     reducing the duration and cost of hospitalization, the risk of nosocomial infection, and~     patients' discomfort.~      There has been no randomized controlled trial (RCT) in the field of IE over the last 20~     years; current guidelines are mostly based on expert advice, in vitro studies, animal~     experiments, or clinical studies performed before the 90's.~      The RODEO 1 project is an unprecedented opportunity to bring back evidence-based medicine in~     the field of IE.~      Most experts acknowledge that the pharmacological PK/PD characteristics of antibiotics such~     as fluoroquinolones and rifampicin allow a high level of efficacy in the treatment of IE when~     orally administrated after an IV period of induction.~      It's needed to conduct RCTs that clearly demonstrate the clinical non-inferiority of this~     strategy for multisusceptible staphylococci with a benefit regarding costs.~      The RODEO 1 project corresponds to one pragmatic trial assessing the impact of a switch~     strategy, making it a comparative effectiveness trial that should be able to feed the next~     revision of IE international guidelines and to change practices in IE management.~   "
66126|NCT02701478|"~     N2O has been used during general anesthesia (GA) for more than 100 years. It is known to have~     anesthetic agents sparing effect. But small is know on his real analgesic effect during GA.~     So far, the only way to monitor pain during GA was based on vital signs that are not specific~     and not sensitive. Few devices tried to evaluated pain under GA during the last 2 decades.~     More recently, better devices were proposed such as the Physiodoloris device and the PMD200~     device. The first offers an index called ANI based on heart rate variability (HRV)~     assessment. The second offers the NoL index based on the analysis of 5 parameters. The aim of~     the present study is to evaluate quantitatively the analgesic index of N2O during GA using~     the two indices ANI and NoL.~   "
66127|NCT02701465|"~     The purpose of this randomized clinical trial is two-fold. Firstly to see if patients~     suffering Subacromial Pain Syndrome can improve blood flow in the supraspinatus muscle in~     their shoulder, and secondly to investigate how changes in this blood flow are related to~     pain experience and shoulder function.~   "
66311|NCT02699073|"~     The purpose of the study is to evaluate the performance of various tumor response criteria~     (Choi and RECIST1.1 criteria) in the assessment of regorafenib activity.~      Moreover, an assessment of the tumor heterogeneity will be made using computed tomographic~     texture analysis (CTTA)~   "
66117|NCT02701595|"~     Infective endocarditis (IE) is a serious infection with a significant burden for patients and~     hospitals (in France, median length of hospital stay = 43 days), partly due to the long~     duration of intravenous (IV) antibacterial treatment recommended by international guidelines,~     between 4 and 6 weeks in most situations.~      A recent survey of practices regarding the management of IE in France showed that a switch~     from IV to oral antibiotics is feasible, when patients with left-sided~     Streptococcus-Enterococcus IE are stable after an initial course of IV antibiotic treatment,~     with or without valvular surgery.~      These practices have not been associated with unfavourable outcome, while significantly~     reducing the duration and cost of hospitalization, the risk of nosocomial infection, and~     patients' discomfort.~      There has been no randomized controlled trial (RCT) in the field of IE over the last 20~     years; current guidelines are mostly based on expert advice, in vitro studies, animal~     experiments, or clinical studies performed before the 90's.~      The RODEO 2 project is an unprecedented opportunity to bring back evidence-based medicine in~     the field of IE.~      Most experts acknowledge that the pharmacological PK/PD characteristics of antibiotics such~     as amoxicillin allow a high level of efficacy in the treatment of IE when orally~     administrated after an IV period of induction.~      It's needed to conduct RCTs that clearly demonstrate the clinical non-inferiority of this~     strategy for streptococci, and enterococci IE with a benefit regarding costs.~      The RODEO 2 project corresponds to one pragmatic trial assessing the impact of a switch~     strategy, making it a comparative effectiveness trial that should be able to feed the next~     revision of IE international guidelines and to change practices in IE management.~   "
66118|NCT02701582|"~     This is a prospective, randomized controlled trial to determine if using FloTrac/EV1000~     system in neurosurgical patients undergoing craniotomies for aneurysm repair or tumor~     resection complicated by cerebral edema, or complex spinal surgery including multi-level~     scoliosis correction, is a more effective way of monitoring fluid.~   "
66119|NCT02701569|"~     The purpose of this study was to investigate the effect of rebound exercise (mini trampoline~     jumping) on metabolic outcomes and quality of life in patients with Type 2 Diabetes.~   "
66120|NCT02701556|"~     The objective of this study is to evaluate the safety and effectiveness of NNR06~     Multi-Purpose Solution cleaning and disinfecting solution (Test) compared to COMPLETE~     Multi-Purpose Solution cleaning and disinfecting solution (Control) when used by habitual~     contact lens wearers to bilaterally clean and disinfect their contact lenses for~     approximately three months.~   "
66121|NCT02701543|"~     To compare two different Paclitaxel coated balloons in the treatment of high grade stenotic~     or occluded lesions in Superficial femoropopliteal artery (SFA )and/or Proximal Popliteal~     Artery in Peripheral Artery Disease (PAD) patients with Rutherford class 2-4.~   "
66122|NCT02701530|"~     The aim of this trial is to develop a new tailored smoking cessation program for smokers with~     low education. Smokers are involved in design of the intervention. The effect of the~     intervention is then tested in a randomised controlled trial. Half of workplaces will be~     offered the intervention and the other half will be control group, not receiving any offer.~   "
66123|NCT02701517|"~     The primary aim of the study was to compare the efficacy of the procedure in terms of~     event-free survival between patients receiving cyclosporine (CsA) plus either alemtuzumab~     (CAMPATH-1H ) or methotrexate (MTX) after matched related donor allo-reduced intensity~     conditioning. Secondary aims were: 1. To compare the incidence of infections and~     transplant-related mortality between the two arms; 2. to compare the incidence of acute and~     chronic GVHD 3. to evaluate hematologic and immunologic reconstitution and evolution of~     chimerism and residual disease.~      Patients were randomly assigned to received cyclosporine plus alemtuzumab or cyclosporine~     plus MTX and were stratified according to diagnosis: Chronic lymphocytic leukemia or Low~     grade- non-Hodgkin's lymphoma.~      All patients received the same reduced-intensity conditioning (RIC) scheme based on~     fludarabine 150mg/m2 (30 mg/m2/day everyday from -8 to -4) plus melphalan 140mg/m2 (70~     mg/m2/day everyday from -3 to -2). Regarding the GVHD prophylaxis, patients in group 1 (n=17)~     received CsA 1 mg/kg intravenously starting on day -7 and 2/mg/Kg from day -1 plus~     alemtuzumab administered at a dose of 20 mg IV on -8 to -4 whereas in group 2 (n=23) pts~     received CsA at same doses as group 1 plus MTX given at a dose of 15 mg/m2 intravenously on~     days 1 and 10 mg/m2 on days 3, 6 and 11, followed by folinic acid rescue (15 mg in +1 and 10~     mg in +3, +6 and +11 intravenously every 6 hours for 4 doses starting 24 hours after each~     dose of MTX).~      Acute and chronic GVHD were similarly graded by established criteria [20, 21]. In patients~     receiving alemtuzumab, CsA was suspended by day +130. They also received donor lymphocyte~     infusion (DLI) at a dose of 1 x 107 cluster of differentiation 3 / kg on day +180 in case of~     active disease, persistence of minimal residual disease detected by flow cytometry or mixed~     chimerism and no GVHD. In case mixed chimerism, donor lymphocyte infusion was performed if~     patient hematopoiesis progressively increased. In patients receiving CsA + MTX, CsA was~     suspended by day +180. These patients received DLI only in situations specified above.~      The statistical analysis has been designed to identify a 20% difference in terms of~     disease-free survival (based on the increased incidence of relapse in patients receiving~     T-cell depletion).~   "
66124|NCT02701504|"~     Sleep apnea is a prevalent disorder in patients with coronary artery disease. Previous~     studies suggested sleep apnea was associated with coronary plaque burden and future adverse~     cardiovascular events. Sleep apnea is also associated with a high incidence of atrial~     fibrillation in patients undergoing coronary artery bypass grafting. Yet, previous reports~     used Berlin Questionnaire and Epworth Sleepiness Scale Questionnaire to diagnose sleep apnea.~     However, these screening questionnaires are not as accurate as a proper sleep study. In the~     SABOT study, the investigators used the portable sleep device to diagnose sleep apnea, and~     evaluate the relationship between sleep apnea and cardiovascular outcomes after coronary~     artery bypass surgery.~   "
66125|NCT02701491|"~     The acute gastroenteritis is a very common problem in children. The frequency and duration of~     this condition involves a high discomfort for the child and his family, and significant~     costs, in connection with the purchase of therapeutic aids, medical visits, days of work lost~     by parents, requiring hospitalization. Vomiting is a typical symptom of the majority of the~     cases of acute gastroenteritis and is very often the cause of failure of oral rehydration use~     and hospitalization.~      To limit vomiting and facilitate oral rehydration have been proposed several pharmacological~     strategies. Unfortunately, these therapies are unsuccessful (domperidone), expensive and side~     effects (ondansetron and metoclopramide) and therefore contraindicated in patients of~     pediatric age.~      The administration of some medicinal herbs is able to induce an effective anti-emetic power.~     Among the various types of plants studied, the rhizome of Zingiber officinale, commonly known~     as ginger is used as an antiemetic in various traditional systems of medicine for over 2000~     years. There are several scientific evidence on the beneficial properties of ginger,~     including antioxidant, antimicrobial, anti-inflammatory and anti-allergic . It was also~     demonstrated that ginger is effective in resolving the post-operative nausea and vomiting and~     in pregnant. A recent meta-analysis has confirmed that ginger is effective in~     non-pharmacological treatment of nausea and vomiting in the early periods of pregnancy.~      To date there are several formulations of the ginger on the market in Italy, and their use is~     fairly widespread in children for the treatment of vomiting by acute gastroenteritis in the~     absence of clinical evidence of efficacy.~      The purpose of the proposed study is to demonstrate the effectiveness of treatment with~     ginger in reducing episodes of vomiting associated with acute gastroenteritis in children.~   "
66325|NCT02698878|"~     The present study aimed to investigate whether a daily intake of lupin protein and a~     neuromuscular electrical stimulation training twice a day can improve local glucose uptake~     into m. soleus during a 60 day unloading phase with a special unloading device, the~     HEPHAISTOS orthosis (HEP).~   "
66128|NCT02701452|"~     In the literature, the risk of moderate to severe OHSS is 3 to 6% and reaches 31% in high~     risk populations 9 days after oocyte triggering with hCG. Many studies report no or a~     markedly decreased risk of OHSS after triggering ovulation with a GnRH agonist. However,~     criteria to define OHSS are rarely explained and OHSS itself is not thoroughly asserted. It~     is well known that OHSS is associated with hypercoagulability. However, no study after~     triggering with a GnRH agonist assessed haemostasis in these high-risk patients with high~     circulating estradiol levels.~      Study design, size, duration: In a French academic reproductive medicine centre, a systematic~     prospective observational follow-up of all patients triggered by GnRH agonist for excessive~     follicular response will be conducted. Participants/materials, setting, methods: All patients~     undergoing antagonist protocol and at high risk of OHSS (estradiol level ≥ 3000 pg/mL and/or~     more than 20 follicles ≥ 11mm on the day of triggering) will be triggered by GnRH agonist. No~     luteal phase support and a freeze-all strategy will be performed. On the day of oocyte~     retrieval (T0), at 48h (T1) and at day 7 (T2), OHSS and hypercoagulability will be~     systematically assessed. Haemostasis data will be compared to the initial status of each~     patient.~   "
66129|NCT02701439|"~     This study is investigating a better method to see if someone has tuberculosis (TB) as~     compared to the method that is being used now.~   "
66130|NCT02701426|"~     Background:~      Obesity increasingly affects young women and contributes to increased maternal, fetal and~     neonatal complications. Maternal obesity contributes to the subsequent development of~     childhood obesity not only through social and environmental mechanisms but also through~     biological processes referring to the original concept of the developmental health and~     disease. Data suggest that management during pregnancy through nutrition counseling and~     adequate physical activity will help to break the familial vicious circle of obesity. To help~     program to be effective it is important to understand the factors that modulate~     participation. However, few studies have been conducted to assess the determinants that~     influence participation.~      Goal:~      The main objective is to analyze 15 factors that influence participation in a program~     combining physical activity and nutritional counseling among pregnant women with BMI ≥ 25~     kg/m2. Secondary objectives are :~        -  to identify the data that influence adherence and to show that assiduous women will have~          a better control of weight gain and a reduction of maternal and fetal complications.~        -  to understand the biological mechanisms involved~      Strategy and method:~      A prospective research evaluating the participation in an educational program, including~     nutritional support and adequate physical activity, will be offered to overweight and obese~     pregnant women. The program will last 12 weeks, and will include three workshops on diet of~     the pregnant and lactating women, and the young child. Physical activity sessions will be~     offered once a week. Fifteen independent variables likely to influence participation will be~     analyzed. The association between participation and the risk of maternal and fetal pregnancy~     complications related to obesity will be analysed. Meanwhile, more fundamental research will~     be considered to determine of the biological factors involved.~   "
66131|NCT02701413|"~     For too many women, childbirth results in devastating consequences: involuntary loss of feces~     or urine (fecal or urinary incontinence). In fact, up to 50 percent of women with severe~     tears during childbirth may develop these problems. These new mothers avoid leaving home in~     order to stay close to a toilet, wear protective pads every day, and avoid activities they~     previously enjoyed such as exercise and sexual intercourse. It is not surprising that many of~     these women suffer from postpartum depression, and bonding with their newborns is~     compromised.~      Fecal and urinary incontinence occur due to injuries to the pelvic nerves and muscles during~     childbirth. Many researchers have focused on what can be done to prevent these injuries;~     however, few have investigated how to help the countless women who have already suffered from~     these injuries to the nerves and muscles. In other fields such as orthopedics and neurology,~     research shows that electrical stimulation can provoke nerve regeneration after injury.~     Applying this technology to women who have recently suffered from nerve injury during~     childbirth could have profound and life-changing effects. Investigators hypothesize that~     electrical stimulation immediately postpartum will markedly help pelvic nerves regenerate,~     minimizing rates of fecal and urinary incontinence for this vulnerable population of new~     mothers.~   "
66132|NCT02701400|"~     This randomized clinical trial studies how well tremelimumab and durvalumab with or without~     radiation therapy works in treating patients with small cell lung cancer that has returned~     after a period of improvement. Monoclonal antibodies, such as tremelimumab and durvalumab,~     may limit the ability of tumor cells to grow and spread by enhancing immune function.~     Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving~     tremelimumab and durvalumab together with radiation therapy may lead to improved clinical~     benefit.~   "
66133|NCT02701387|"~     The purpose of this study is to determine whether implant thread design impacts bone~     remodeling and/or dental implant stability in the early healing period.~      The population of this study will consist of a group of subjects who are interested in~     replacing two or more missing teeth with dental implants. All implant sites will be healed~     and not require bone augmentation for the placement of a standard 4 mm diameter implant.~     Subjects first will undergo a brief screening exam. If accepted, comprehensive oral exam will~     be completed. Subsequently, enrolled subjects will be scheduled for dental surgery to place~     the implant(s). Subjects will return weekly for the first 8 weeks after placement for a brief~     post-operative appointment in order to conduct measurements for the study.~   "
66134|NCT02701374|"~     In Post-Herpetic Neuralgia(PHN) patients:~        -  To conduct an explorative investigation of the efficacy and safety of repeated oral~          doses of TRK-700 via a randomized double blind comparative study~        -  To measure the plasma concentration of TRK-700 and its metabolites~   "
66135|NCT02701361|"~     Many survivors of the intensive care unit (ICU) suffer from persistent symptoms of~     depression, anxiety, and post-traumatic stress disorder (PTSD). In this study, the~     investigators will test the impact of mindfulness to address this distress.~   "
66136|NCT02701348|"~     The purpose of this study is to monitor the change in cancer size in women with breast cancer~     on anti-hormone treatment using different types of assessment including ultrasound scan (US),~     shearwave elastography (SWE) and magnetic resonance imaging (MRI), and assess how this~     corresponds to the changes in the cancer biology.~   "
66148|NCT02701192|"~     The purpose of the study is to analyze the outcomes of patients with coccygodynia (pain in~     and around the coccyx region) treated with coccygectomy (a procedure during which the coccyx~     is removed) and to report on the rate of complications of the procedure. The study will also~     aim to find pre-operative clinical predictors of good outcomes after coccygectomy. The~     investigators hypothesize that coccygectomy will not improve scores on the Short Form-36~     (SF-36), Oswestry Disability Scale (ODI), tolerable sitting time, or Visual Analog Pain Scale~     (VAS). Also, the investigators hypothesize that there are no independent variables associated~     with improved outcomes.~   "
83900|NCT02468804|"~     We hypothesize that reductions in gamma activity are a key mechanism underlying cognitive~     dysfunction in PD and that interventions to increase gamma activity will improve cognition.~   "
66137|NCT02701335|"~     Osteoarthritis (OA) of the hand is a major cause of pain and functional limitation, central~     sensitization of pain can be one of the causes: this hypothesis opens avenues for research in~     the modulation of pain pathways. The peripherally directed therapies may modulate pain~     perception bilaterally. This hypothesis opens avenues for future research in the modulation~     of pain pathways, perhaps offering targets to optimize peripheral manual and physical~     therapies for pain management in hand OA.~      Several studies have reported the outcomes of multimodal approach to central sensitization~     evaluated by generalized pressure pain hypersensitivity in patients with carpometacarpal~     (CMC) OA. Neurodynamic techniques are a form of manual therapy directed to the neural~     structures through positioning and movement of multiple joints. Recent technologies have~     facilitated the use of robots as tools to assist patients in the rehabilitation process thus~     maximizing patient outcomes. These robotic tools assist the patient with carrying out~     exercise protocols, optimal for the activity of the control group.~   "
66138|NCT02701322|"~     The purpose of this study is to determine whether a participation of a medical clown in~     videofluoroscopic examination of pediatric speech disorder such as velopharyngeal inadequacy,~     improves the collaboration of the pediatric patient, the patient's and the caregivers~     subjective experience, and the quality of the examination (shorter exposure to radiation,~     shorter time at the radiology suite, more accurate parameters retrieved from the imaging~     results).~   "
66139|NCT02701309|"~     This study aims to evaluate a prototype device detecting zinc protoporphyrin-IX fluorescence~     non-invasively from the intact oral mucosa in children. The prototype device has shown high~     sensitivity and specificity in women after delivery for iron deficiency. Children are at~     increased risk for iron deficiency and prevention methods are not established jet. Zinc~     protoporphyrin-IX is an early indicator of iron deficiency and may be more sensitive than~     other established parameters. The prototype device is used to measure the erythrocyte zinc~     protoporphyrin-IX/heme ratio in children aged 9 months to 5 years. Children in this age are~     at increased risk for iron deficiency as they are growing rapidly and iron deficiency in this~     age may affect the neurodevelopment and immune system adversely. It is proposed that these~     effects cannot be rectified by iron supplementation in later years. The results from the~     non-invasive measurements are compared to reference measurements of the erythrocyte zinc~     protoporphyrin-IX/heme ratio from residual blood samples from the same patients and to other~     indicators of iron status, including hemoglobin, ferritin, serum iron, transferrin,~     transferrin saturation and soluble transferrin receptor.~   "
66140|NCT02701296|"~     To assess pain control after total knee replacement surgery using two different nerve block~     techniques. The 2 methods are:~        1. Continuous femoral nerve block with ultrasound guided posterior capsular injection~        2. Continuous femoral nerve block with ultrasound selective tibial nerve block.~   "
66141|NCT02701283|"~     The study objective is to demonstrate that the safety and effectiveness of the Medtronic TAVR~     system as measured by rates of all-cause mortality or disabling stroke at two years is~     noninferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low~     predicted risk of operative mortality for SAVR.~   "
66142|NCT02701270|"~     The purpose of this study is to determine whether DuPont Experimental Dietary Fibre products~     1 and 2 are digested using glycaemic and insulinaemic response as markers.~   "
66143|NCT02701257|"~     This study will compare two different models of a wearable bionic pancreas device (the~     iPhone-based bionic pancreas vs. the iLet bionic pancreas) in adult participant with type 1~     diabetes. Both bionic pancreas devices measure glucose levels every five minutes and then~     give insulin and/or glucagon automatically to regulate the blood glucose (BG).~   "
66144|NCT02701244|"~     For women diagnosed with early stage breast cancer, lumpectomy followed by radiation is a~     common treatment option. Radiation treatment is typically delivered to the whole breast, five~     times per week, for anywhere from 3 to 8 weeks. The radiation helps kill any cancer cells~     that may have been left over following the surgery but causes skin burns. Many studies have~     demonstrated that radiation to the whole breast is not necessary, that it can be delivered to~     a portion of the breast where the cancer is more likely to recur.~      A technique called a Permanent Breast Seed Implant (PBSI) involving the implantation of~     radioactive seeds has been developed to deliver the radiation to a portion of the breast. The~     procedure is performed on an out-patient basis under local anesthesia and light sedation.~     Because the radioactive seeds are permanently implanted in the breast, the patient is able to~     live a normal life while the seeds deliver the prescribed radiation to the breast.~      Previous studies on PBSI demonstrate that it is a safe and effective alternative form of~     radiation for appropriately selected patients after lumpectomy. However, those results have~     been obtained mainly from a single institution, with only 4 patients treated in another~     center. Further research is still needed to evaluate its safety in a multi-center setting.~     The purpose of this study is to ensure the appropriate training of clinicians who will be~     performing this procedure and to capture long term outcomes and rare complications if any.~   "
66145|NCT02701231|"~     The purpose of this study is to determine whether Low-frequency Rotating Magnetic Therapy~     System is effective and safe in the treatment of advanced lung cancer.~   "
66146|NCT02701218|"~     Unilateral posterior canal benign paroxysmal positional vertigo (BPPV) cases will be~     randomized to treat with single or multiple cycles of canalith repositioning procedure.The~     treatment outcomes will be assessed at 7th and 28th days.~   "
66147|NCT02701205|"~     This is a randomized, double-blind, multicentral clinical trial to investigate the efficacy~     and safety of Recombinant Human TNF Receptor-Ig Fusion Protein for Injection (Qiangke®) in~     the treatment of Moderate to Severe Plaque Psoriasis. The primary purpose is to assess the~     different maintaining treatment programme in Moderate to Severe plaque psoriasis by Qiangke®.~     And the second purpose is to assess the efficacy and safety of Qiangke® in Moderate to Severe~     Plaque Psoriasis. The trial will include 216 Moderate to Severe plaque psoriasis patients,and~     at the first stage they will be randomized divided into three group: full-dose of Qiangke®~     group, half-dose of Qiangke® group and placebo group.And the blind stage will last for 12~     weeks. Then at the second stage, all patients will receive 50mg qw of Qiangke® for additional~     12 weeks.~   "
66433|NCT02697409|"~     A two armed randomized trial is evaluating the effect of the medical-student-delivered~     school-based intervention Education Against Tobacco on the smoking behavior of adolescents in~     7th grade of secondary school. The primary endpoint is the change in smoking prevalence~     between the two groups.~   "
66149|NCT02701179|"~     Flexible bronchoscopy is one of the most widely performed procedures for diagnosis of various~     bronchopulmonary diseases. Most patients tolerate the procedure well although cough is often~     reported as a distressing symptom. It is likely that the acceptance of bronchoscopy would be~     significantly improved with control of cough. Use of sedation during bronchoscopy has been~     reported to improve procedure tolerance. However, awake(no sedation) bronchoscopy is~     routinely performed at many centres including ours.~      Topical lignocaine is administered during bronchoscopy for local anaesthesia. There is~     limited literature on the efficacy of lower concentrations (1%) versus a higher (2%) during~     bronchoscopic procedures. This study would help to determine whether 1% lignocaine is as~     effective as 2% lignocaine for airway anaesthesia during flexible bronchoscopy.~   "
66150|NCT02701166|"~     Randomized double blind placebo controlled trial to evaluate the antipruritic effect of~     bezafibrate in patients with moderate to severe cholestatic itch.~   "
66151|NCT02701153|"~     This phase II trial studies the side effects of hypofractionated radiation therapy in~     treating patients with soft tissue sarcomas that have come back before surgery.~     Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter~     period of time and may kill more tumor cells and have fewer side effects.~   "
66152|NCT02701140|"~     The aim of this study is to assess the pleiotropic effects of ticagrelor that could represent~     possible mechanisms for its beneficial effects on cardiovascular mortality. We will test~     three different hypotheses:~        1. Ticagrelor may increase ischemic preconditioning as compared to clopidogrel in patients~          with stable coronary disease, showing multivessel coronary artery disease and undergoing~          staged PCI.~        2. Ticagrelor may improve microvascular perfusion in the myocardium of patients with~          multivessel coronary artery disease undergoing staged PCI.~        3. Ticagrelor may exert positive effects enhancing the paracrine modulation, migration,~          homing and survival of hBMDSC, with a potential impact on the microvascular dysfunction~          and on the protective response to ischemia (cellular preconditioning).~   "
66153|NCT02701127|"~     This is a single center, randomized, single-blind, placebo-controlled study to evaluate the~     safety and biochemical effects of niacinamide on metabolic parameters of the kidney in~     patients undergoing cardiac surgery.~   "
66154|NCT02701114|"~     This study is designed to evaluate pain control of continuous adductor canal blocks placed~     proximally versus distally within the canal. The investigators hypothesize that there will be~     similar pain control between both groups.~   "
66155|NCT02701101|"~     This is a multi-site, longitudinal study to evaluate the use of the SEM Scanner as an adjunct~     to clinical judgment for detection of early pressure ulcers in patients before skin~     assessments.~   "
66156|NCT02701088|"~     Anal canal carcinoma (ACC) represents 1.2% of digestive cancers. Its incidence is increasing.~     As epidermoid ACC (95% of ACC) are particularly sensitive to radio and chemotherapy,~     concomitant radio-chemotherapy is the standard treatment of locally advanced ACC, with proven~     efficacy on locoregional control, anal sphincter preservation, progression-free survival and~     complete response rate higher than 80%.~      Nevertheless, conventional radiotherapy frequently induces significant non-haematological~     toxicities requiring treatment interruptions. Thus, treatment usually includes a chemotherapy~     (5-Fluorouracil and Mitomycine-C) and 25 fractions of 1.8 Gy followed by a planned 1-week (or~     more) interruption and a boost, for a total 54-60 Gy radiation dose over 9 weeks.~      Considering the numerous anatomic pelvic structures, ACC has become a localisation of~     interest for Intensity-Modulated Radiation Therapy (IMRT) associated with less toxicity.~      However, IMRT induces grade≥3 cutaneous toxicities requiring irradiation breaks. Dose~     escalade did not show its interest: 60 Grays remains the standard.~      Assuming the deleterious effect of increased overall treatment time on local control and~     survival in head-and-neck and cervical cancers and the epidermoid histology of ACC, the~     benefit of no irradiation break on ACC tumour control is of interest.~      IMRT offers the possibility to deliver different doses to different target volumes~     simultaneously by altered fractionation schedule like SIB-IMRT (simultaneously integrated~     boost-IMRT). Several SIB-IMRT schedules have been retrospectively evaluated. Similar results~     were observed with moderate doses and schedules delivering higher doses with short~     interruptions. Nevertheless, standard SIB-IMRT schedule in ACC still not exist.~   "
66157|NCT02701075|"~     The FDA-approved MC5-A Scrambler Therapy (MC5-A ST) is an electroanalgesia device that~     interferes with pain signal transmission by using nerve fibers as a passive means to convey a~     message of normality (sans pain) to the central nervous system. While preliminary research~     has demonstrated its efficacy in treating chronic neuropathic pain secondary to cancer and~     failed back surgery syndrome, its effectiveness in treating chronic neuropathic pain~     secondary to traumatic musculoskeletal injuries like those experienced in combat has not been~     investigated. The purpose of this prospective, double-blind, randomized controlled, study is~     to determine if the MC5-A ST is efficacious in altering the biological, psychological, and~     social components of the chronic neuropathic pain experience in military Service Members~     (SMs) with traumatic musculoskeletal extremity injuries.~   "
66158|NCT02701062|"~     Patients without a documented history of AF but who present with a CHA2DS2- VASc of => 2 and~     HASBLED of => 2 and will undergo a valve or CABG (structural heart) procedure with direct~     visual access to the LAA will be eligible to participate based upon the inclusion and~     exclusion criteria defined in this protocol. Up to 2000 patients will enroll at up to 40~     sites and will be randomized 2:1 (2 with AtriClip to 1 without AtriClip. Subjects who not~     develop Post-operative Atrial Fibrillation (POAF) will be followed for 30 days for safety.~     Subjects who develop POAF and receive the AtriClip will be followed for 365 days post index~     procedure.~   "
66169|NCT02700919|"~     The purpose of this study is to compare the efficacy and safety of BCT197 when added on to~     standard of care in adult subjects with acute respiratory exacerbations of chronic~     obstructive pulmonary disease requiring hospitalization. Additionally, the study will~     characterize the pharmacokinetics of BCT197 in adults with COPD. The total duration of the~     study will be 26 weeks. Subjects will receive study treatment administration over a period of~     5 days after randomization. It is expected that approximately 255 subjects will complete the~     study and follow-up.~   "
66170|NCT02700906|"~     The investigators hypothesized that lidocain injection is as effective as corticosteroid~     injection in management of tennis elbow, and if so, it may replace corticosteroid injection~     in the management of tennis elbow.~   "
66159|NCT02701049|"~     This trial is the final phase of a three phase PCORI-funded study to develop and test~     patient-centered approaches to collect sexual orientation and gender identity (SO/GI)~     information in the ED. From the results of Phase 1 qualitative interviews and national~     quantitative survey and Phase 2 Delphi rounds with the Stakeholder Advisory Board, we have~     determined two methods of collection favored by patients and providers to implement in the~     trial. The first method, nurse verbal collection, is in alignment with Partners recommended~     clinical practice and is therefore a quality improvement (QI) evaluation. The second method,~     non-verbal registrar form collection with nurse verbal confirmation, is a research~     intervention to evaluate and compare a new patient-centered approach to SO/GI collection. To~     compare the patient-centeredness of the two different approaches, satisfaction surveys will~     be administered to ED patients and staff members involved in collection.~      In summary, the study design (1) evaluates recommended current practice (QI), (2) evaluates a~     quality improvement project to increase recommended current practice, and (3) evaluates a new~     method of collecting SO/GI (research intervention).~   "
66160|NCT02701036|"~     The key goals of SPORTAX-NHS is to compare the phenotype of multiple system atrophy of~     cerebellar type (MSA-C) and sporadic adult onset ataxia of unknown aetiology (SAOA) and to~     determine the rate of disease progression in both groups including determination of the~     factors that predict the development of MSA-C vs. SAOA, and at which time after onset of~     ataxia, a reliable distinction between both disorders is possible.~      The planned study will also allow to collect blood samples and other biomaterials from~     patients with sporadic ataxia, which will be useful for future genetic and biomarker studies.~   "
66161|NCT02701023|"~     The aim of this study is to evaluate the feasibility, safety, and efficacy of MitoGel in the~     treatment of UTUC in a human subject with low-grade UTUC which is endoscopically unresectable~     or rapidly recurring, and in whom nephrectomy would likely result in the need for permanent~     hemodialysis. The study drug would be obtained under the single patient access program~     approved by the FDA. The patient would then undergo instillation of MitoGel into the affected~     kidney. The catheter would be left indwelling in the ureter and would be externalized. The~     ureteral and urethral catheters would remain indwelling for the duration of the 6 treatments,~     which would occur twice weekly for 3 weeks or once weekly for 6 weeks. Following the final~     instillation, the catheters would be removed. The patient would then undergo ureteroscopic~     evaluation at 3 months following the final instillation of MitoGel. The total duration of~     study would be 3 months. The total number of study patients is 1.~   "
66162|NCT02701010|"~     Researchers aimed to identify the effectiveness of three methods of patient education for~     behavioral therapy (BT), including verbal instructions combined with a leaflet on a~     structured training program of BT, only verbal instructions on a structured training and only~     a leaflet on a structured BT training. Therefore, a randomized controlled trial was designed~     to compare effectiveness of those methods of patient education in BT based on the two~     validated patient- reported outcome measures (PROMs) for women with overactive bladder.~      Idiopathic overactive bladder (iOAB) symptoms in female patients are perceived as normal,~     which does not threaten life and not require to be treated immediately. It is necessary to~     raise the awareness of iOAB on women. The education and consultancy role of continence nurses~     is important in the treatment and care of urinary incontinence (UI) associated with iOAB. In~     the study, it was seen that the training to be provided to patients is helpful regardless of~     the teaching method used. Also it was found that the method of verbal instructions in the~     form of a structured training plus giving a leaflet to patient is the most effective method~     of BT for female iOAB.~   "
66163|NCT02700997|"~     This study seeks to gain a more thorough understanding of the postoperative location of the~     sutures placed during uterosacral ligament suspension. Characterization of the surrounding~     anatomy in a living model will enhance surgical technique by delineating safer suture~     locations and decrease the incidence of morbid complications for patients.~   "
66164|NCT02700984|"~     The purpose of this study is to evaluate the long-term safety of the CyPass Micro-Stent in~     subjects who completed Study Protocol TMI-09-01, COMPASS Trial.~   "
66165|NCT02700971|"~     This trial will utilize a Molecular MicroscopeTM diagnostic system (MMDxTM) that combines the~     molecular and histopathological features of biopsies, plus clinical and laboratory~     parameters, to create the first Integrated Diagnostic System. This MMDxTM will be utilized to~     phenotype cutaneous melanoma biopsy samples to detect an immune responsive mRNA signature.~   "
66166|NCT02700958|"~     Contrast-induced nephropathy (CIN) has remained significant and severe complication of~     angiographic procedures despite the increasing use of preventative methods. It has been~     associated with prolonged hospital stay, high morality and the need for dialysis. Since~     classically used creatinine for diagnosing of CIN does not reflect the degree of tubular~     injury before 24-48 hours after exposure to contrast media alternative earlier biomarkers and~     preventative methods are needed. Remote ischemic preconditioning is a non-invasive and safe~     method which in some studies has been reported to protect against contrast-induced~     nephropathy. The purpose of this study is to evaluate the effect of remote ischemic~     preconditioning (RIPC) (1) as an additional method to standard treatment to prevent~     subclinical and clinical contrast-induced acute kidney injury and (2) to assess its effect on~     functional properties of arterial wall, organ damage biomarkers and low molecular weight~     metabolites.~   "
66167|NCT02700945|"~     The purpose of the Stroke AF study is to compare the incidence of atrial fibrillation (AF)~     through 12 months between continuous cardiac rhythm monitoring with the Reveal LINQ™~     Insertable Cardiac Monitor (ICM) (continuous monitoring arm) and standard of care (SoC)~     medical treatment (control arm) in subjects with a recent ischemic stroke of presumed known~     origin.~   "
66168|NCT02700932|"~     This is an open-label, multi-center study. Subjects in this study will receive up to eight~     (8) treatments in 11±5 weeks (6-16 weeks) interval, with the PicoWayTM device using the 1064~     nm/ 785±20 nm/ 532 nm handpiece according to the study protocol (tattoo colors). Subjects~     will return for one follow‐up (FU) visit at the clinic at 8 weeks following the last~     treatment.~      Methodology described in the protocol to evaluate efficacy and safety of treatments will be~     carried out at each visit at the clinic~   "
66277|NCT02699515|"~     The main purpose of this study is assess the safety and tolerability of MSB0011359C. Study~     consists of dose-escalation part and an expansion part in subjects with metastatic or locally~     advanced solid tumors, for which no standard effective therapy exists or a standard therapy~     has failed.~   "
66171|NCT02700893|"~     Observational ancillary study of the PRETTINEO study (ClinicalTrials.gov Identifier:~     NCT01490580) which is a multicenter double blind randomized controlled trial comparing~     atropine+propofol vs atropine+atracurium+sufentanil as a premedication prior to~     endotracheal intubation of the neonate.~      Primary outcome:~        -  Cerebral desaturation defined by a rScO2 delta >20% from the baseline value (before~          premedication).~        -  Variation of more than 10% of cerebral FTOE (Fractional Tissue Oxygen Extraction) during~          premedication, calculated from rScO2 and pulse oximetry with the formula FTOE=SaO2 -~          rScO2/SaO2 .~      Hypothesis: atropine + propofol compared to atropine+atracurium+sufentanil does not~     increase the frequency of cerebral hypoxemia.~   "
66172|NCT02700880|"~     The WEARIT-III registry enrolls subjects with ischemic cardiomyopathy and heart failure~     (including NYHA II, III, IV and an ejection fraction ≤ 35%) who wear a medically prescribed~     ZOLL LifeVest Wearable Defibrillator. The primary objective of the WEARIT-III Registry is to~     prospectively document the clinical course of high-risk cardiac patients with heart failure~     and ischemic cardiomyopathy prescribed with Wearable Cardioverter Defibrillator (WCD), such~     as left ventricular function recovery, arrhythmia, Implantable Cardioverter Defibrillator~     (ICD), Cardiac Resynchronization Therapy (CRT), Left Ventricular Assist Device (LVAD), heart~     transplantation, and to assess the benefit of WCD in heart failure patients with ischemic~     cardiomyopathy.~   "
66173|NCT02700867|"~     The investigators sought to compare the intraosseous access success rates of the proximal~     tibia and the proximal humerus using new Intraosseous access device NIO in an adult cadaver~     model during simulated resuscitation.~   "
66174|NCT02700854|"~     This is a Phase I, open-label, single center trial to evaluate the feasibility and safety of~     low concentration CO2 gas mixture (5% CO2 + 95% air) inhalation in asphyxiated, cooled,~     mechanically ventilated newborns at risk of hypocapnia with The hypothesis is that~     hypocapnia, which is driven by hyperventilation in the presence of metabolic acidosis, is~     deleterious to the injured brain and can be safely avoided with low concentration CO2~     inhalation.~   "
66175|NCT02700841|"~     This pilot, randomized phase II trial studies how well depleted immune suppressor stem cell~     transplant works compared to standard stem cell transplant in enhancing immune response to~     vaccines in patients with multiple myeloma (MM). Chemotherapy and the patient's own stem~     cells are effective in treating MM, however there is a risk of disease returning due to poor~     recovery of the immune system as shown to poor response to vaccines to prevent infections.~     Before chemotherapy, patients' stem cells are collected and certain immune cells called~     suppressor cells are removed from the stem cells. Patients then receive chemotherapy to kill~     cancer cells and after that the immune depleted stem cells are returned to them to replace~     the blood-forming cells that were destroyed by chemotherapy. Giving depleted immune~     suppressor stem cells transplant to patients with MM may result in a more robust immune~     response to vaccines after transplant and may prevent MM from returning. It is not yet known~     whether depleted immune suppressor stem cell transplant is more effective than standard stem~     cell transplant in enhancing immune response to vaccines in patients with multiple myeloma.~   "
66176|NCT02700828|"~     This is a prospective, randomized, double-blind, placebo controlled, single center study to~     compare low dose hydrocortisone vs placebo in systemic low blood pressure during hypothermia~     treatment in asphyxiated newborns. Patients will be allocated to one of the treatment arms~     (hydrocortisone or placebo) while receiving conventional inotropic therapy as needed.~      The hypothesis is that cooled asphyxiated neonates develop relative adrenal insufficiency~     that may contribute to hypotension and lower efficacy of inotropic therapy in this patient~     population. Thus, the investigators are planning to measure initial serum cortisol levels and~     investigate the cardiovascular effects of low dose hydrocortisone supplementation besides~     conventional inotropic therapy in a placebo-controlled fashion.~   "
66177|NCT02700815|"~     This randomised, controlled multi-centre parallel group trial will assess the efficacy and~     tolerability of a topical formulation gel of the combination of diclofenac and capsaicin in~     comparison to gels with diclofenac alone, capsaicin alone, and placebo for the treatment of~     acute back pain or neck pain~   "
66178|NCT02700802|"~     The Feed1st proposed program of research will promote health of informal caregivers with a~     hospitalized child by testing a self-management intervention that addresses the widely~     overlooked problem of caregiver hunger. As many as 54% of parents and other informal~     caregivers of hospitalized children struggle with insufficient food to nourish themselves and~     their family during and after a hospital stay. Hunger impairs caregiver physical and mental~     health by depleting energy for self-care, emotional self-regulation, and supportive~     interactions with the child, the family, and the formal caregiver team. The long-term~     objective of the Feed1st program is to alleviate hunger and food insecurity among families~     with hospitalized children. Established in partnership with nursing and chaplaincy leadership~     at our children's hospital and the Greater Chicago Food Depository, the Feed1st program~     currently operates self-serve food pantries on four inpatient units and the emergency~     department in our children's hospital on Chicago's South Side. Since 2010, Feed1st has~     provided nearly 8500 pounds of food to at least 4,000 individuals and 1500 households via the~     self-serve food pantries in the children's hospital. Over this same period, our team has also~     created a system for efficiently connecting families to community-based resources for hunger~     and other basic needs.~   "
66179|NCT02700789|"~     Study to determine the diagnostic accuracy of the double decidual sac sign to predict an~     intrauterine pregnancy prior to ultrasonographic visualisation of embryonic contents using~     modern ultrasound technology.~   "
66180|NCT02700776|"~     The purpose of this study is find out if a protein level in the blood (called PC Cell Derived~     Growth Factor or glycoprotein 88 [GP88]), combined with standard mammography screening, can~     help detect breast cancer better than mammography screening alone. Earlier research has shown~     that a certain glycoprotein 88 (GP88) is higher in women with breast cancer.~      In this study, investigators will measure the level of GP88 in the blood of healthy women who~     are having mammography screening for breast cancer. The investigator plans to correlate the~     results of the mammogram with the GP-88 level.~   "
66278|NCT02699502|"~     Metabolic therapy in patients with osteoporosis after hip fracture by cooperation~     orthopedic-rehabilitation-metabolic: Determination of drug treatment regardless of reaching~     the follow-up clinic~   "
66181|NCT02700763|"~     In this feasibility study, [18F]dabrafenib will be used as radioactive tracer. All patients~     in this study are diagnosed with advanced melanoma with evidence of brain metastases and are~     eligible for treatment with dabrafenib, a specific V600-mutated BRAF inhibitor. Patients will~     undergo a dynamic PET scan of the brain to determine [18F]dabrafenib distribution and~     kinetics in brain metastases. In addition, a static total body PET scan will be performed to~     visualize whole body distribution and tracer uptake.~   "
66182|NCT02700750|"~     The investigators will enroll and scan normal eyes of healthy individuals using the~     Spectralis OCT. Each scan is graded on a scale of 0-40, with 0 representing the lowest~     quality and 40 the best possible one. Each of the participants will be scanned numerous times~     using this noninvasive imaging tool, while trying to get as many scans as possible of~     different quality. The differences in the parameters between the scans will then be recoded.~      Collected data will include age, sex, subjects' refractive status, visual acuity, full slit~     lamp exam and the participants' OCT characteristics and measurements.~   "
66183|NCT02700737|"~     To answer the research question: Would image-based modelling result in different clinical~     decisions as compared to clinical practice guidelines?, we will conduct a randomized~     controlled experiment in which we will compare the hypothetical decisions made by~     interventional cardiologists who are presented with imaging parameters currently recommended~     by clinical practice guidelines vs. hypothetical decisions made by interventional~     cardiologists receiving an expanded list of parameters, including simulation modelling.~   "
66184|NCT02700724|"~     This trial is a randomized, multi-center, non-inferiority study comparing observation versus~     immediate surgery for low grade, noninvasive bladder cancer.~   "
66185|NCT02700711|"~     This study will determine the influence of methylphenidate (e.g., Ritalin®) and duloxetine~     (Cymbalta®), alone and in combination, on the cocaine use as measured by self-report and~     urine drug screens.~   "
66186|NCT02700698|"~     The main goal of this project is to determine whether mitochondrial function in circulating~     cells is related to that measured in the muscle fibers of the same subjects.~   "
66187|NCT02700685|"~     This double blind, randomised controlled trial examines the effect of a commercially~     available nutritional supplement on behaviour of ADHD patients, as well as on their physical~     and psychiatric co-morbidities, and level of oxidative stress and immune activity, as~     compared to placebo and standard pharmaceutical treatment for ADHD.~   "
66188|NCT02700672|"~     The study analyses if cognition and gait speed can predict falls in a community-dwelling~     people and ambulant long term care residents~   "
66189|NCT02700659|"~     The aim of this trial is to determine the performance characteristics of the Cxbladder test~     for the detection of recurrent urothelial carcinoma (UC) in patients with a recent history of~     urinary tract UC, who have been treated according to standard practice and are undergoing~     routine investigative cystoscopy.~      The gold standard for determination of clinical truth is cystoscopy, plus any follow up~     investigations relating to the current visit.~   "
66190|NCT02700646|"~     The purpose of this study is to learn more about developmental behaviors and to examine~     changes in developmental progress related to motor activities among a group of infants who~     received open heart surgery within the first three months of life.~   "
66191|NCT02700633|"~     Pacemaker requirement in the immediate post procedure phase following TAVI is approximately~     20% depending on device type and patient characteristics. There is a signal from recent~     studies suggesting increased risk of sudden cardiac / unexplained death in the first 30-60~     days. This study aims to address whether there is a mortality advantage to having a pacemaker~     in the short term~   "
66192|NCT02700620|"~     Background: Previous studies on Internet-based treatment with eating disorders have shown~     promising results.~      Objective: The first aim of this study was to investigate the effects of a tailored therapist~     guided internet-based treatment for individuals with eating disorders. The second aim was to~     examine the role of knowledge acquisition.~      Method: 138 participants were recruited. Screening consisted of online questionnaires~     followed by a telephone interview. A total of 92 participants were included after a~     semi-structured diagnostic interview and randomized to an 8 week treatment program (n=46) or~     to a control condition (n=46). Treatment consisted of individually prescribed cognitive~     behaviour therapy text modules in conjunction with online therapist guidance. The control~     group consisted of a waitlist who later received treatment.~   "
66193|NCT02700607|"~     After obtaining approval from the Institutional Review Board of our institution, written~     informed consent is obtained from patients undergoing interventional cerebral aneurysm~     coiling procedure are enrolled in this prospective study and randomly allocated into one of~     two groups: Group-C (n=10) and Group-HES (n=10).~      All recruited patients will be given patient identification number (PIN) for the present~     study of 01-20 according to their order of interview and recruitment. Investigators will~     prepare 10 yellow and 10 green cards, which will be inserted in 20 thick-paper envelopes.~     Then, all envelopes will be sealed, mixed and randomly allocated to get numbers of 01 to 20~     (Envelop number). After printing the envelope number outside envelope, all sealed envelopes~     with cards will be conveyed to and kept in pharmacy department.~      According to the color of the card, attending anesthesiologists will give crystalloid for~     yellow card or HES for green cards, respectively, to maintain stroke volume variation < 15~     during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture.~      Patient data and statistical analyses:~      Patient's data whole blood viscosity, PaO2, FiO2, Hemoglobin, urine amount, s-glucose will be~     determined from the patients' medical record after patient's discharge.~      All statistical analyses will be performed after the 20th patient's discharge and data~     acquisition~   "
66194|NCT02700594|"~     Patients with painful knee conditions often present with hip muscle weakness. This weakness~     can lead to, and perpetuate, knee problems. Diminished strength causes movement impairments~     that can lead to pathology, functional limitations and disablement. In some cases, this hip~     muscle weakness is not caused by simple disuse and muscle shrinkage (atrophy). Hip weakness~     may be caused by an inhibitory mechanism that limits the force output of a muscle. The~     inhibition is reflexive and is in response to pain or joint dysfunction. Joint~     mobilization/manipulation can quickly reduce pain and improve joint function, possibly~     decreasing inhibition and increasing strength. Joint mobilization/manipulation may facilitate~     strength recovery. By restoring strength sooner, the patient may avoid the deleterious~     effects of prolonged muscle weakness and achieve quicker or better outcomes.~   "
66195|NCT02700581|"~     The purpose of this study is to determine the difference in the impact of moderate positive~     end-expiratory pressure (PEEP) on hepatic venous flow Doppler in patients undergoing cardiac~     surgery: conventional versus protective ventilation strategy The possible changes in forward~     and backward flows (Doppler profiles) of hepatic venous flow at different degrees of PEEP in~     conventional and protective ventilation strategies are analyzed by using intraoperative~     transesophageal echocardiography (TEE) in patients undergoing cardiac surgery .~   "
66196|NCT02700568|"~     Aim of the FavorAx study is to evaluate preliminary efficacy and safety of Axitinib in~     metastatic renal cell carcinoma patients with favorable IMDC prognostic factors who had~     progressed on sunitinib or pazopanib in the first-line setting.~   "
66197|NCT02700555|"~     A prospective, single center, cohort study for surveillance of metabolic parameters in~     patients who will receive chemotherapy after surgical resection of colorectal cancer~   "
66198|NCT02700542|"~     The New York City Department of Health and Mental Hygiene and Montefiore Medical Center, with~     the Fund for Public Health of New York (FPHNY), DOHMH's fiscal agent, are partnering on a~     study to evaluate the feasibility, health outcomes and return-on-investment of a single,~     integrated pest management (IPM) intervention for Bronx, Harlem, and Northern Manhattan~     children aged 5 to 12 with persistent asthma who are living in homes with pests. By~     demonstrating cost effectiveness, this study could provide the basis for health insurance~     coverage of an IPM visit embedded in clinical treatment plans for high-risk asthma patients~     living with pests.~      Asthma is the most common childhood disease in New York City, and both prevalence and~     hospitalization rates are highest in high-poverty neighborhoods. The greatest individual and~     community-level factor associated with asthma disparities is varying exposure to triggers in~     the home, most notably cockroaches and mice. Asthma health care costs are significant, and~     prevention efforts to reduce triggers could result in improved outcomes and significant cost~     savings. Unlike traditional pest control, which relies on pesticides, IPM eliminates pests~     and prevents re-infestation by addressing housing conditions conducive to pests and with~     safe, targeted use of pesticides. This project targets low-income children with the potential~     to significantly improve their health and well-being. A total of 400 families - 400+ children~     which includes screened and recruited siblings - will be recruited on to the study.~      The study is designed to evaluate an inexpensive and scalable environmental intervention for~     asthma that can be replicated in other New York City neighborhoods and incorporated into any~     urban healthcare setting in New York State and nationwide.~   "
66199|NCT02700529|"~     Leukotriene B4 (LTB4) inhibits lymphangiogenesis in the mouse tail model of lymphedema and is~     elevated in tissue in patients with lymphedema. Ubenimex is an inhibitor of leukotriene A4~     hydrolase (LTA4H), the biosynthetic enzyme for LTB4. This proof-of-concept study is designed~     as a randomized, double-blind, placebo-controlled study comparing ubenimex at 150 mg, 3 times~     daily (total daily dose of 450 mg) with placebo for 6 months treatment period in patients~     with leg lymphedema. The primary objectives for the study are:~        -  To evaluate the efficacy of ubenimex in patients with leg lymphedema~        -  To evaluate the safety and tolerability of ubenimex in patients with leg lymphedema~   "
66200|NCT02700516|"~     Glomerulonephritis (GN) is the leading cause of end-stage renal disease in 30% to 50% of~     patients who receive a renal transplant. The exact prevalence of either recurrent or de novo~     GN is unknown since a considerable number of patients never undergo allograft biopsy, leaving~     GN underdiagnosed. The aim of this study is to evaluate the effects of recurrent GN on the~     prevalence, risk factors, clinicopathological features, and outcome of renal transplant~     recipients.~   "
66201|NCT02700503|"~     This study uses patient engagement to develop a diabetes prevention program focused on~     adolescents and families.~   "
66202|NCT02700490|"~     This study is a cluster randomised controlled trial, which aims to examine the short-term~     strategy of addressing treatment gap through increasing primary mental health service~     capacity. This study aims to compare after 6 months and 12 months, the effectiveness of a~     specialist model of mental health care and an enhanced usual care (task-sharing) framework,~     in terms of reducing mental health symptoms, reducing disability, and improving quality of~     life, as well as the health services costs (and potentially societal costs) associated with~     these outcomes in 400 patients.~   "
66203|NCT02700477|"~     Trigonella Foenum-Graecum, commonly known as Fenugreek, is a plant that has been extensively~     used as a source of anti-diabetic compounds Fenugreek is traditionally used in India,~     especially in the Ayurvedic and Unani systems.~      Preliminary animal and human trials suggest possible hypoglycemic and anti-hyper lipidemic~     properties of Fenugreek seed powder, when taken orally. Fenugreek seeds contain 50% fiber~     (30% soluble fiber and 20% insoluble fiber) that can slow the rate of post-prandial glucose~     absorption. This may be a secondary mechanism for the hypoglycemic effect.~   "
66204|NCT02700464|"~     Clinical trial to determine the efficacy (sensitivity and specificity) of the Bladder~     EpiCheck test compared to the gold standard cystoscopy and pathology in patients under~     monitoring for recurrence of bladder cancer.~   "
66205|NCT02700451|"~     Patients undergoing spine surgery often have considerable pain post-operatively and~     frequently require opioid medication (Percocet, Norco, oxycodone, morphine, etc.) to control~     their pain postoperatively. The widespread use of opioids, however, is associated with a~     number of side effects. These include: sedation, dizziness, nausea, vomiting, constipation,~     dizziness and itching amongst others. Some investigators have suggested that~     anti-inflammatory medications (the same class of medicines as advil, ibuprofen, etc.) and~     acetaminophen (Tylenol) can reduce the total dose of opioid required postoperatively and, as~     a result, lower opioid-related side effects.~      The purpose of this study is to test this hypothesis and determine if postoperative~     anti-inflammatory medications and postoperative acetaminophen can reduce the amount of opioid~     required to control pain following surgery. A secondary goal of this study is to examine if~     the change in pain medication will lead to decreased overall pain levels, decreased~     opioid-related side effects and improved function [quicker ambulation with physical therapy~     (PT), earlier return to work, etc.].~   "
66206|NCT02700438|"~     A prospective randomized study was performed. Compliance with the treatment and healing rate~     of chronic anal fissure in patients receiving glyceryl trinitrate ointment (GTO) and subjects~     undergoing percutaneous posterior tibial nerve stimulation (PPTNS) were evaluated .~   "
66207|NCT02700425|"~     The goal of this study is to compare the effectiveness of pacing from a physiologic His~     bundle (HB) lead position versus with the standard coronary sinus (CS) lead position in~     subjects with heart failure undergoing cardiac resynchronization therapy (CRT). While~     placement of left ventricular leads via the coronary sinus has anatomic limitations, we~     hypothesis that the achievement of QRS narrowing with His bundle capture will be superior for~     improving systolic function by echocardiographic indices (ejection fraction and strain) and~     quality of life and decreased rehospitalization and mortality.~   "
66208|NCT02700412|"~     The purpose of this study is to evaluate the safety and tolerability of Epidiolex at various~     doses between 5 mg/kg/day and 50 mg/kg/day as an additional (add-on) drug for treating~     debilitating, drug-resistant epilepsy.~   "
66209|NCT02700399|"~     The purpose of this study is to determine if the pulse pressure changes are different whether~     patients are training in a traditional tilt table as compared to a robotic assisted tilt~     table, which induces leg movement.~   "
66210|NCT02700386|"~     The proposed study is being done to learn more about a particular dose of radiation treatment~     for breast cancer that is completed in a shorter amount of time than what has traditionally~     been used to treat breast cancer. Subjects are being asked to be in this research study~     because they have already had surgery for breast cancer and some cancer cells were found in~     their lymph nodes that drain the breast tissue.~   "
66211|NCT02700373|"~     This is a randomized, double-blind, placebo-controlled, single ascending dose study to assess~     the safety and tolerability of PDC-APB by intramuscular (IM) injection compared to placebo.~   "
66212|NCT02700360|"~     A Randomized, Open-Label, Single -Dose, Crossover, Phase I Clinical Trial to Evaluate the~     Effect of Food on the Safety, Tolerability and Pharmacokinetics of EC-18 after Oral~     Administration in Healthy Volunteers~   "
66213|NCT02700347|"~     The purpose of this study is to evaluate the bactericidal activity against Mycobacterium~     tuberculosis of pyrazinamide in combination with allopurinol. Pharmacokinetics (PK) and whole~     blood bactericidal activity (WBA) will be measured in healthy volunteers following~     administration of pyrazinamide alone and in combination with allopurinol.~   "
66214|NCT02700334|"~     Prediabetes is a term that refers to alterations in glucose homeostasis, including impaired~     fasting glucose (IFG), impaired glucose tolerance (IGT) or both, involving a higher risk of~     progression type 2 diabetes mellitus (T2DM).~      Dapagliflozin is a selective and reversible inhibitor of sodium-glucose type 2 (SGLT-2)~     co-transporter, which reduces renal glucose reabsorption and promotes the glucose excretion~     through urine, so that the blood glucose is improved in patients with T2DM. Although this~     mechanism is independent of insulin, there are evidence of improved secretion and insulin~     sensitivity, so it is interesting to assess these effects in patients with prediabetes, as~     potential therapy for treating such disorders and prevent progression to T2DM.~      The aim of this study is to evaluate the effect of Dapagliflozin on insulin secretion and~     insulin sensitivity in patients with prediabetes.~      The investigators hypothesis is that the administration of dapagliflozin improve insulin~     secretion and insulin sensitivity in patients with prediabetes.~   "
66215|NCT02700321|"~     The aim of this study is to determine whether High Flow nasal cannula (HFNC) oxygen is more~     efficient than the standard High Flow face mask (HFFM) for preoxygenation before orotracheal~     intubation after crash induction in non severely hypoxemic patients~   "
66216|NCT02700308|"~     Conventional vertebroplasty is an effective option in the treatment of bone lesions~     (osteoporotic and neoplastic). It is indicated as an analgesic treatment and aims at~     reinforcing a compressed vertebrae or at risk of fracture.~      The main adverse event related to vertebroplasty use is the cement leakages that might be~     responsible for significant clinical impairments.~      Kyphoplasty is a recent alternative strategy of vertebroplasty, based on the insertion on~     balloon through the needle into the targeted vertebrae and then inflation of the balloon~     prior to cement injection into the space.~      In an osteoporotic setting, kyphoplasty allow reducing the incidence of cement leakage.~      To date, no data from randomized study are available in the population of cancer patients.~   "
66217|NCT02700295|"~     Orthokeratology has the benefit for slowing down myopia progression and enabling unaided~     vision during the day. To investigate proposed possible changes of conventional and~     multifocal orthokeratology in the cornea and choroid this study will image both structures~     with high resolution optical coherence tomographs over a six month period. Findings will help~     to plan larger trials over a longer period of time in adults and teenagers.~   "
66218|NCT02700282|"~     Cystic Fibrosis is a hereditary, chronic respiratory illness. Cystic Fibrosis leads to a~     progressive decline in lung function.~      School-aged children with cystic fibrosis experience backpack carrying everyday. Backpack~     carrying induce a restrictive effect responsible for lower lung function. Respiratory muscle~     strength is also impaired.~      No studies assessed aerobic capacities during children's gait while carrying a backpack.~      The investigators hypothesized that backpack carrying will induce an acute decline in lung~     function in children with cystic fibrosis compared to healthy children. Investigators also~     hypothesized that aerobic capacities will be impaired.~   "
66219|NCT02700269|"~     Investigators will evaluate approaches using magnetic bead capture, isolation, and surface~     tension valve transfer of biomarkers to process capillary blood in order to improve the~     sensitivity of already approved Rapid Diagnostic Tests (RDTs) for detection of human malaria~     infection. Results will be compared to those obtained using unenhanced capillary blood~     specimens directly applied to approved malaria RDTs. Participants seeking care for possible~     malaria in Zambia will be recruited to enroll in the study.~   "
66220|NCT02700256|"~     The purpose of this pilot study is to find out if patients are willing to self-report~     symptoms in the first 5 days following discharge, or when they leave the hospital after~     ambulatory surgery (ambulatory surgery is when the patient has surgery and then goes home~     within 24 hours).~   "
66221|NCT02700243|"~     In this research study the investigators want to learn more about whether using a fitness~     tracker and accelerometer helps patients with cystic fibrosis exercise more regularly, and in~     turn whether it increases exercise tolerance over the period of one year.~   "
66279|NCT02699489|"~     A phase III randomized trial conducted to compare recovery outcomes between laparoscopic and~     open donor nephrectomy within a specified enhanced recovery protocol~   "
66222|NCT02700230|"~     This phase I trial studies the side effects and the best dose of a vaccine therapy in~     treating patients with malignant peripheral nerve sheath tumor that cannot be removed by~     surgery (unresectable) or has come back after a period of improvement (recurrent). Vaccines~     made from a gene-modified virus may kill tumor cells expressing a gene called neurofibromin 1~     (NF1) without affecting surrounding normal cells and may also help the body build an~     effective immune response to kill tumor cells.~   "
66223|NCT02700217|"~     About 1100 living donor nephrectomies are performed in the UK every year contributing to~     almost 35% of all the kidney transplants. Laparoscopic surgical techniques are general~     employed for donor nephrectomy as they are associated with a shorter hospital stay and faster~     return to normal physical functioning. Local anaesthetic infiltration technique with or~     without spinal anaesthesia in combination with a general anaesthetic is increasingly being~     used as part of enhanced recovery programme across general surgery. The impact of combined~     spinal and general anaesthesia along with local infiltration and rectus sheath blocks on~     acute pain has not been studied in patients undergoing hand assisted laparoscopic live donor~     nephrectomy.~      The investigators plan to investigate whether adding a spinal anaesthetic to a conventional~     general anaesthetic technique actually influences clinical outcomes of length of hospital~     stay and acute pain in patients undergoing hand assisted laparoscopic live donor nephrectomy.~      The investigators plan to randomise 90 patients undergoing hand assisted laparoscopic live~     donor nephrectomy over 24 month period at Central Manchester University hospitals and divide~     them in two groups of 45 each. Group A will receive a general anaesthetic (GA) with spinal~     anaesthesia (Spinal group) and Group B will receive a GA with a rectus sheath block (Rectus~     sheath group) and local anaesthetic infiltration~   "
66224|NCT02700204|"~     This is an open-label, two-arm, histological evaluation study.~      Subjects in this study will be assigned to Arm 1 or Arm 2, taking into account skin type, to~     receive PicoWay fractional treatment:~      Arm 1: 532nm hand-piece Arm 2: 1064nm hand-piece Subjects will receive one treatment for peri~     auricular and/or Buttocks according the Investigator decision, with the fractional hand-piece~      All subjects will have biopsies from the treated area:~        -  at baseline prior to treatment;~        -  immediately after treatment (within 30 minutes) or 48 hours after treatment;~        -  2 months after treatment. Methodology described in the protocol to evaluate efficacy and~          safety of treatments will be carried out at each visit at the clinic.~   "
66225|NCT02700191|"~     Subjects that are being treated at the Congestive Heart Failure clinic in Nazareth will be~     given the µ-Cor system to be added to their standard care, and randomized 1:1 to an~     interventional arm or a control arm.~   "
66226|NCT02700178|"~     This study will evaluate movement of the arm and forces put through the hand during~     activities performed in a manual wheelchair. The goal of this study is to identify what~     motions and forces are most likely to lead to the development of pain or pathology and~     determine the feasibility of strategies to modify movements and decrease risk.~   "
66227|NCT02700165|"~     The purpose of this study is to further evaluate the safety and efficacy of non-invasive~     reduction of subcutaneous fat in the submental and submandibular area using Cryolipolysis.~   "
66228|NCT02700152|"~     Prospective, blinded, one arm, baseline-controlled clinical study for the evaluation of the~     UltraShape treatment for non-invasive abdominal fat reduction.~      Study subjects will undergo UltraShape treatments on the abdominal area~   "
66229|NCT02700139|"~     The aim of this clinical trial is to compare the rate of myopic progression in children~     wearing aspheric (MyLens) and spherical/ toric ophthalmic lenses. The proposed lens design is~     an aspheric lens which is supposed to slow myopic progression in children by unique~     asphericity (proprietary information). Myopic progression is quantified by changes in axial~     length (AL) and cycloplegic refractive error (Rx) will be monitored for 6-12 months (6 months~     crossover) with double-masking. Peripheral refraction and ocular aberration will be~     evaluated.~   "
66230|NCT02700126|"~     In neurosurgical anesthesia, propofol based total intravenous anesthesia (TIVA) is frequently~     used due to brain relaxation and less effect on electrophysiologic monitoring. Response to~     propofol can vary between individuals and be associated with clinical factors including age~     and weight, and genetic polymorphism. Because the importance of rapid recovery in~     neurosurgery with long operation time is emphasized recently, the choice and dose adjustment~     of anesthetics should be determined according to clinical and genetic factors. Recently,~     researches about genetic variations have been performed with single nucleotide polymorphism~     (SNP). The aim of this study is to determine SNPs associated with propofol recovery and~     response in Korean adult population undergoing propofol based TIVA for clipping of unruptured~     cerebral aneurysm.~   "
66231|NCT02700113|"~     The purpose of this study is to provide a detailed description of language and cognitive~     profiles found among children and adolescents diagnosed with autism spectrum disorders (ASD).~     Participants with ASD ages 4-17;12 years who have limited verbal skills will be given~     comprehensive behavioral assessments to collect data that will advance our understanding of~     language-related processes in individuals with ASD, the knowledge of which will help in~     designing future interventions for this population.~   "
66232|NCT02700100|"~     The study is a prospective, non-randomised, open label clinical study to assess the safety of~     the Bioabsorbable Pulmonary Valved (PV) conduit (PV-001) in subjects > 2 years and < 22 years~     of age, undergoing Right Ventricular Outflow Tract (RVOT) reconstruction. It is a first in~     man feasibility study which will include 10-12 patients in up to 6 sites in Europe.~      The primary objective of the study is to assess the survival rate of subjects at 6 months~     following implantation of the Bioabsorbable Pulmonary Valved Conduit (PV-001).~      Secondary objectives:~        1. The survival rate of subjects at 12 months following implantation of the Bioabsorbable~          Pulmonary Valved Conduit (PV-001)~        2. The percentage of conduit failure at 6 months and 12 months, where conduit failure~          includes the need for reintervention or reoperation.~        3. The pressure gradient across the pulmonary valve will have an acceptable level at 12~          months follow up.~        4. The pulmonary regurgitation measured will not exceed a moderate grading at 12 months~          follow up.~        5. To evaluate the usability of the Bioabsorbable Pulmonary Valved Conduit (PV-001) during~          the surgical procedure, using exploratory parameters~      Long term safety will be assessed up to 60 months post implantation.~   "
84204|NCT02464852|"~     The aim of this study is to evaluate the effects on MND patients of a new collar specifically~     designed for people affected by neck weakness: the Sheffield Support Snood.~   "
66233|NCT02700087|"~     All neonates, ages 0 to 4 months, presenting to LPCH pediatric ENT clinic for airway~     difficulties or stridor will be screened for inclusion. As is consistent with an acceptable~     standard of medical care, these children will undergo a flexible nasal endoscopic exam to~     make the diagnosis of laryngomalacia, as well as be weighed and a breastfeeding history~     taken. If laryngomalacia is present, the study staff with then administer the Infant~     Gastroesophageal Reflux Questionnaire (IGERQ) and an airway symptoms questionnaire (ASQ).~      Those babies with an IGERQ score of less than sixteen (no more than mild reflux) and an ASQ~     score greater than six will be eligible for randomization. The patient will then be randomly~     placed in the control group (placebo) or the intervention group (ranitidine 2mg/kg every 12~     hours or famotidine 0.5 mg/kg daily). Patients will stay on medication for a minimum of 6~     months, or until symptoms resolve. Patients will be seen in follow up at 1, 2, 3, 4, 5, 6, 8~     and 10 months. At which time I-GERQ, ASQ and weights will be taken. The primary outcome~     measure will be the time for the ASQ score to drop to normal on ranitidine or famotidine~     versus placebo.~      A secondary outcome will be weight gain in percentile. If the patient's I-GERQ score goes~     above 16 at any time in the study, the patient will be crossed over to the treatment arm and~     started on medical treatment.~   "
66234|NCT02700074|"~     The main goal of our study is to find out why some people with Autism Spectrum Disorder (ASD)~     do not develop verbal abilities or remain minimally-verbal throughout adolescence and~     adulthood. Current research focuses on investigating brain differences related to processing~     sounds and initiating speech in adolescents and young adults with ASD varying in language~     skills, compared to adolescents who do not have ASD, in order to clarify whether atypical~     processes of auditory perception, perceptual organization and/or neural oscillation patterns~     may explain why some individuals with ASD fail to acquire functional speech.~   "
66235|NCT02700061|"~     The purpose of this study is to evaluate and compare the effects of upper limb training with~     Induced Constraint Therapy (ICT) or robotic therapy. No placebo therapy is used. Motor~     function, neurological evaluations and quality of life are assessed for the comparison of the~     therapies.~   "
66236|NCT02700048|"~     This is a single center, single-blind randomized cross over design trial that will compare~     the impact of intra-nasal naloxone vs. intra-nasal saline administration during experimental~     hypoglycemia on day one on responses to experimental hypoglycemia on day two. Investigators~     intend to enroll 18 individuals to obtain the complete data sets from 15 participants.~     Expected duration of subject participation is 10-12 weeks. This study will consist of two~     2-day intervention visits separated by approximately 8 weeks.~   "
66237|NCT02700035|"~     This study will complete a multisite randomized controlled trial (RCT) of a family-centered~     alcohol and drug prevention program for Anishinabe (Ojibwe) pre-adolescents in 3rd or 4th~     grade (Fall 2017) or who are age 8-10 years on June 1, 2017. The 14 week program includes~     cultural lessons to strengthen family interactions, decrease substance use, teach parenting~     skills, increase social skills, improve refusal skills, and teach coping mechanisms for~     adolescents and parents. Session are expected to last around 3-hours, including a meal, youth~     and parent breakout sessions, and group based discussions. Parents and adolescents will~     participate in a pre-test before the program begins and a series of post-tests after the~     program ends.~   "
66238|NCT02700022|"~     This phase I/Ib study is designed to establish the safety and maximum tolerated dose (MTD,~     which will also be the recommended phase II dose (RP2D)) of the aurora kinase A inhibitor~     alisertib when combined with dose-adjusted (DA)-R-EPOCH (rituximab, etoposide, doxorubicin,~     vincristine, cyclophosphamide and prednisone) in patients with CD20-positive diffuse large~     B-cell lymphoma (DLBCL), transformed follicular lymphoma or Burkitt lymphoma positive for Myc~     gene rearrangement (Myc+). Filgrastim or peg-filgrastim is also included with each cycle of~     R-EPOCH. Once we identify the MTD, an expansion cohort limited to the Myc+ DLBCL population~     will be opened to further characterize clinical activity and safety.~      Secondary objectives include estimates of complete response rate (CR) and progression free~     survival (PFS). We will also explore for associations between baseline kinome signatures~     and/or RNA sequencing and CR, and identify differential kinome and transcriptome prior to and~     during treatment.~   "
66239|NCT02700009|"~     Computer-assisted cognitive-behavior therapy, a treatment that has been shown to be effective~     in previous studies in psychiatric settings, will be disseminated into primary care - a~     health care setting where there are significant problems in receiving adequate treatment for~     depression. Computer-assisted cognitive-behavior therapy will feature a low-cost method of~     delivering therapy designed to be replicated and sustained in other primary care settings.~     Feasibility and effectiveness will be tested by randomly assigning 320 primary care patients~     with depression to receive either computer-assisted cognitive-behavior therapy or treatment~     as usual.~   "
66240|NCT02699996|"~     This partially randomized pilot trial studies peer mentoring to see how well it works in~     promoting follow-up care self-management in younger childhood cancer survivors. Childhood~     cancer survivors require lifelong follow-up care to identify, monitor, and treat medical and~     psychosocial late effects stemming from their cancer, its treatment, and lifestyle factors. A~     peer mentoring program may improve disease knowledge, health motivation, problem-solving~     skills, stress management, and communication with caregivers and providers in adolescent and~     young adult cancer survivors.~   "
66241|NCT02699983|"~     This randomized pilot clinical trial studies how well a virtual weight loss program~     (SparkPeople) works in helping female African American breast cancer survivors maintain a~     healthy weight. Many patients with breast cancer are overweight or gain weight after~     diagnosis. SparkPeople is a free web-based weight loss program that features educational and~     motivational articles and videos, self-monitoring tools, incentives, social support~     communities (including discussion forums, teams, challenges, and expert blogs), and options~     for content to be delivered to members' email. It is a comprehensive program that includes~     advice on diet, physical activity, and behavioral strategies (such as self-monitoring diet~     and exercise), and emphasizes safe weight loss and receiving medical attention regularly when~     needed. A web-based program such as SparkPeople may help breast cancer survivors maintain a~     healthy weight, which may reduce the risk of cancer returning and patient fatigue, and~     improve patient quality of life.~   "
66242|NCT02699970|"~     The objective of this study is to evaluate precision of the Philips Dx system.~   "
66243|NCT02699957|"~     The Left Atrial Appendage Occlusion Registry (LAAO Registry™) is designed to assess the~     prevalence, demographics, management, and outcomes of patients undergoing percutaneous and~     epicardial based left atrial appendage occlusion procedures to reduce the risk of stroke.~     Patient-level data will be submitted by participating hospitals on a quarterly basis to the~     American College of Cardiology Foundation's National Cardiovascular Data Registry (NCDR). The~     primary aims of the LAAO Registry are to optimize the outcomes and management of patients~     through the implementation of evidence-based guideline recommendations in clinical practice,~     facilitate efforts to improve the quality and safety for patients undergoing percutaneous and~     epicardial based left atrial appendage procedures, investigate novel quality improvement~     methods and provide risk-adjusted assessment of patients for comparison with nationwide NCDR~     data. The secondary purpose of the LAAO Registry is to serve as a rich source of clinical~     data to support assessments of short- and long-term safety, comparative and cost~     effectiveness research, and as a scalable data infrastructure for post market studies.~   "
66244|NCT02699944|"~     Despite advancements in implant technology and various techniques of optimization, there is~     still around 30% non-responder rate to cardiac resynchronization therapy (CRT). This study~     will assess the potential benefit of a body surface mapping technology to optimize CRT~     devices in the chronic sub-optimal responder setting.~   "
66245|NCT02699931|"~     This study evaluates if electric toothbrushes with a 3D action (rotation / oscillation and~     pulsation) are more effective than manual toothbrushes in removing plaque and reducing~     gingival inflammation in patients under orthodontic treatment with fixed appliances.~   "
66246|NCT02699918|"~     Hypothesis: to address if diagnosis of obstructive sleep apnea before or during the extending~     check-up is a risk factor toward metastasis for melanoma stage ≥ tIIaN0M0 Study design: Adult~     patients with a Breslow's Thickness ≥ 1mm coming to the surgery consultation will have a~     nocturnal oximetry for screening of obstructive sleep apnea. Patients having an abnormal~     nocturnal oximetry will be explored by polysomnography in order to detect sleep apnea~     syndrome. Patients with sleep apnea will be treated.~      Standard dermatologic follow-up over a 3 years period with thoraco-abdominal-pelvic and~     cerebral CT-scan and a lymph-node ultrasound every 6 months will be performed.~   "
66247|NCT02699905|"~     This study seeks to elucidate the quantitative expression of G - protein receptor 43/free~     fatty acid (GPR43/FFA2) receptors in patients with the diagnosis of sepsis and specifically,~     its expression as it relates to the severity of sepsis. The investigators hypothesize that~     patients with more severe sepsis, as defined by a higher SOFA (Sequential Organ Failure~     Assessment Score), will have decreased expression of the GPR43/FFA2 as compared to patients~     with lower SOFA scores, consistent with a less exuberant immune response to infection.~      Patients admitted to Penn State Hershey Medical Center with a diagnosis of sepsis of any~     cause will undergo blood testing of leukocytes to determine the expressed quantity of GP43~     during standardized time points of their illness and recovery. No interventions will be made~     in the standard clinical management of the patient. Additionally, healthy volunteers will be~     recruited to exam baseline GPR43 receptor expression between sepsis and control groups.~   "
66248|NCT02699892|"~     This Phase IV post-marketing, non-interventional, open label, non-comparative and prospective~     study will examine the efficacy and safety of rituximab in participants who had previously~     received rituximab in terms of everyday medical practice. Efficacy and safety of rituximab~     will be determined 24 weeks after receiving the first infusion, 24 weeks after the second~     infusion repeated courses of treatment (if the participants receive another course of~     rituximab) and 24 weeks after the third infusion repeated courses of treatment (if the~     participants receive third course of rituximab). Protocol does not specify the criteria for~     initiation of treatment with rituximab and procedure of the infusion of rituximab. Rituximab~     will be administered at the discretion of treating physician according to approved label.~   "
66249|NCT02699879|"~     This single arm, post-authorisation study is designed to evaluate the long-term safety of~     pirfenidone in participants with IPF. The enrolment of participants will be completed within~     approximately 24 months. Participants will receive pirfenidone according to the physician~     discretion and will be followed for 2 years. Treating physicians will collect pre-specified~     data at the baseline and every 3 months thereafter, for the duration of the participants'~     participation in study.~   "
66250|NCT02699866|"~     The Straumann Bone Level Tapered (BLT) implant Ø 2.9 mm implant was developed to allow~     treatment of patients with single tooth gaps of small dimensions in the lateral and central~     incisor positions in the mandible and in the lateral incisor positions in the maxilla. These~     positions are reduced-load-bearing compared to more posterior positions.~      During this study performance and safety of the Straumann BLT implants Ø 2.9 mm in the~     clinical practice setting will be investigated.~   "
66251|NCT02699853|"~     This randomized phase II trial studies how well robotic radical cystectomy (RRC) or open~     radical cystectomy (ORC) works in treating patients with bladder cancer. Cystectomy is a~     surgical procedure to remove all or part of the bladder (the organ that holds urine) or to~     remove a cyst (a sac or capsule in the body). In RRC, the the surgeon makes small cuts in the~     abdomen and uses a thin, lighted instrument with a camera attached called a scope. With the~     help of a robot, the surgeon removes the bladder and other nearby structures. In ORC, the~     surgeon makes a cut into the lower abdomen to expose the urinary tract in order to remove the~     bladder and nearby structures. It is not yet known whether RRC or ORC has fewer~     complications, better quality of life, and faster recovery time in treating patients with~     bladder cancer.~   "
66252|NCT02699840|"~     The aim of this study is to generate local data on the safety of Menactra® in individuals 2~     to 55 years of age in the Russian Federation.~      Primary Objective:~        -  To describe the safety profile after 1 dose of Menactra® administered in individuals~          2-55 years of age under standard health care practices.~   "
66253|NCT02699827|"~     This study aims at evaluating the effect of adding magnesium sulphate epidurally as an~     adjunct to levobupivacaine on the quality of anesthesia and perioperative pain relief in~     patients with preeclampsia undergoing elective caesarian section (CS).~   "
66280|NCT02699476|"~     The purpose of this study is to compare different combinations of cognitive training in~     retired professional football players and military veterans with a history of repeated~     concussions and persistent symptoms of impaired memory, concentration, attention, focus, or~     thinking.~   "
66254|NCT02699814|"~     The goal of this project is to develop and pilot test a community-based integrated care model~     to improve the prevention, early detection and treatment of child mental health problems that~     is replicable, effective, and sustainable. Project procedures include child mental health~     screening, on-site brief mental health interventions, referral to specialty mental health,~     use of co-located child psychiatrist, detection of need for primary care in specialty mental~     health program. Subjects will be enrolled for 1 year, with interviews at baseline and 3, 6~     and 12 months.~      Dr. Bonnie Zima at UCLA has been contracted by the project funder to design and implement the~     evaluation of the project, which includes developing data collection procedures, training~     staff on implementation of data collection workflow, coordinating with sites to ensure~     evaluation design and IRB protocols are followed, and coordinating with both study sites to~     verify data reliability.~      Some potential anticipated risks include being uncomfortable answering questions associated~     with the measures used in the study, and although unlikely, someone may access participant~     information that is confidential. Some benefits include helping to find ways to improve how~     to deliver mental health care for children served in publicly-funded primary care and mental~     health clinics.~   "
66255|NCT02699801|"~     Increasing numbers of elderly patients are undergoing cardiac surgery. Elderly patients may~     have prolonged recovery following cardiac surgery when compared to other groups of patients,~     and are at higher risk of postoperative delirium, postoperative neurocognitive decline and~     reduced quality of life following hospital discharge.~      The goals of sedation and analgesia for patients following cardiac surgery are multifold and~     include postoperative pain relief, the facilitation of ventilation, resolution of hypothermia~     and normalization of electrolyte balances. The choice of sedative agent however can impact~     postoperative outcomes. Dexmedetomidine has been associated with improved quality of recovery~     in patients undergoing major spine surgery and with a reduced incidence of delirium, both of~     which can impact a patient's quality of life following surgery. The investigators~     hypothesized that the use of dexmedetomidine as a sedative agent immediately following~     cardiac surgery in elderly patients would result in improved quality of recovery and a~     reduced incidence of delirium in the postoperative period, when compared to propofol. The~     investigators were also interested as to whether there was an associated improvement in~     neurocognitive outcomes in this population.~      Questions:~        -  Does the use of dexmedetomidine as a sedative agent in ICU in elderly patients following~          cardiac surgery result in improved Quality of Recovery scores when compared with~          propofol?~        -  Does the use of dexmedetomidine as a sedative agent in ICU in elderly patients following~          CABG+/- AVR result in a reduced incidence of postoperative delirium as compared to~          propofol?~        -  Do these patients subsequently have a reduction in cognitive decline?~   "
66256|NCT02699788|"~     The goal of this study is to assess a new non-invasive computerized, multiphase, resting~     electrocardiogram analysis device in early identification of patients at risk for acute~     coronary syndrome. The overall objective is to assess the association between the results~     from a resting MCG and 30-day cardiovascular outcome in patients presenting to the emergency~     department with suspected coronary disease.~   "
66257|NCT02699775|"~     Chronic stroke patients exhibit gait pattern alterations which are mainly due to spasticity~     and treated with repetitive multifocal botulinum toxin injection(BTI). Several studies~     demonstrated that single BTI-session in a single muscle of paretic lower limb(LL) improved~     kinematic gait parameters(GP) but surprisingly none of them assessed the effects of~     repetitive multifocal BTI on patient's gait pattern and their duration.~      The aim was to evaluate the impact of repetitive multifocal BTI-sessions on GP of chronic~     stroke patients. To that end, gait of patients will be compared using 3D-gait analysis after~     3 consecutives BTI sessions.~   "
66258|NCT02699762|"~     To show that the addition of a self-rehabilitation program to standard treatment, involving~     repeated BTI and usual physiotherapy, improves impairment and activity limitation of the~     paretic upper limb more than the control treatment (BTI + usual physiotherapy), in a~     randomised controlled study of patients with spastic hemiparesis following stroke.~   "
66259|NCT02699749|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and~     maximum tolerated dose (MTD) of TAK-931 in participants with advanced nonhematologic tumors.~   "
66260|NCT02699736|"~     The EuroSIDA study is a prospective observational cohort study of 20,000+ patients followed~     in 100+ clinics in 35 European countries, Israel and Argentina. The study is the largest~     pan-European cohort study and few studies of a comparable design are available on a global~     scale. The EuroSIDA study is an ongoing collaboration and patients have been enrolled into~     the study through 10 cohorts since 1994.~      The main objective of the study remains the same as in1994: to prospectively study, clinical,~     therapeutic, demographic, virological and laboratory data from HIV-1 positive persons across~     Europe in order to determine their long-term virological, immunological and clinical~     outcomes.~      Historically, EuroSIDA has been crucial in reporting key changes in the HIV epidemic, such as~     the dramatic changes in morbidity and mortality when combination anti-retroviral therapy~     (cART) was first introduced. As new anti-HCV treatment is introduced to HIV/HCV co-infected~     patients, it is important for EuroSIDA to remain in the forefront of investigating the~     treatment benefits and adverse effects.~      All study documents, study status, newsletters, scientific publications and presentations are~     available online and are updated continuously at project website.~      In general terms, the objective of the EuroSIDA study is to continue a long-term, prospective~     collection of clinical, laboratory and therapeutic data as well as plasma on a large cohort~     of consecutive HIV infected patients from across Europe in order to (1) assess the factors~     associated with the clinical, immunological and virological course of HIV infection and~     HIV-related co-infections and co-morbidities, and (2) continue to provide and develop a~     surveillance system to describe temporal changes and regional differences in the clinical~     course of HIV and HIV-related co-infections and co-morbidities in Europe.~   "
66261|NCT02699723|"~     This pilot clinical trial studies how well arsenic trioxide and itraconazole work in treating~     patients with basal cell cancer that has spread to other places in the body and usually~     cannot be cured or controlled with treatment. Drugs used in chemotherapy, such as arsenic~     trioxide, work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Itraconazole may~     help treat fungal infections in patients with basal cell cancer. Giving arsenic trioxide with~     itraconazole may work better in treating basal cell cancer.~   "
66281|NCT02699463|"~     The investigators wish to prospectively determine the response to CPAP in patients presenting~     with mild OSA. In many healthcare systems, patients with mild OSA (AHI 5-15) are not~     reimbursed for treatment. Although some evidence exists of the benefits of treating mild OSA~     when scoring as per AASM 2007 criteria, more evidence is needed. The investigators wish to~     add to this pool of knowledge and also increase the inclusion criteria to include the AASM~     2012 definition of mild OSA. By including the 2012 AASM definition of mild OSA, the~     investigators will add novel information to the field by assessing the benefits of treatment~     in both sub-groups of mild OSA.~   "
66262|NCT02699710|"~     This study is a Phase I, single center, randomized (Parts 1 and 2 only), open-label, 3 part~     study. Parts 1 and 2 are 2-way crossover, with 1-fixed sequence, 3-period designs to~     investigate the effect of formulation, food and rabeprazole on the PK of GDC-0853 in healthy~     male and female (of non-childbearing potential) participants. Part 3 is a fixed-sequence~     study with 3 treatments to characterize the steady-state PK of the GDC-0853 tablet; the~     effect of simultaneous administration of a single dose of methotrexate on the steady-state~     kinetics of GDC-0853; and the effect of dosing GDC-0853 to steady-state on the single dose PK~     of methotrexate in healthy male participants.~   "
66263|NCT02699697|"~     This randomized phase II trial studies how well palliative radiation therapy works in~     reducing pain in patients with cancer that has spread from the original (primary) tumor to~     the bone (bone metastasis). Palliative radiation therapy using external beam radiation~     therapy may help patients with bone metastasis to relieve symptoms and reduce pain caused by~     cancer.~   "
66264|NCT02699684|"~     The purpose of this study is to evaluate AIR OPTIX® plus HYDRAGLYDE® (AOHG) contact lenses~     compared to AIR OPTIX® AQUA (AOA) contact lenses in overall lens fit.~   "
66265|NCT02699671|"~     The purpose of this study is to evaluate the relative effectiveness and safety of~     Bioresorbable Vascular Scaffold in acute myocardial infarction compared to other (drug~     eluting stents) DES.~   "
66266|NCT02699658|"~     Levofloxacin, a fluoroquinolone antibiotic, is the optical S-(-) isomer of ofloxacin with a~     broad spectrum of activity. In common with other fluoroquinolones, the main~     pharmacokinetic/pharmacodynamic (PK/PD) index that correlates with its therapeutic efficacy~     is the area under the plasma time-concentration curve/the minimum inhibitory concentration~     ratios.~      The aims of the study were to:~        1. reveal the population pharmacokinetics, and~        2. assess the efficacy of various dosage regimens in achieving the probability of target~          attainment (PTA) and the cumulative fraction of response (CFR) of levofloxacin when oral~          levofloxacin was prescribed as the switching therapy after intravenous levofloxacin~          treatment.~      The study was conducted in 45 healthy volunteers. Each subject received one 500 mg tablet of~     levofloxacin, after which PK studies were carried out, using a Monte Carlo simulation to~     determine the PTA. By referral to the EUCAST MIC distributions database, the dosage regimens~     were predicted to achieve CFR greater than or equal to 90%.~   "
66267|NCT02699645|"~     An investigator initiated and conducted, multicentre, international, double-blinded,~     placebo-controlled, parallel-group, randomised controlled trial to determine the effects of a~     fixed low-dose combination blood pressure lowering pill (Triple Pill) on top of standard of~     care on blood pressure control and on time to first occurrence of recurrent stroke in~     patients with a history of acute intracerebral haemorrhage (TRIDENT).~   "
66268|NCT02699632|"~     The main goal for this study is to assess concerns and barriers to research participation by~     pregnant women through an anonymous online survey~     (www.pbrc.edu/ParticipateWhilePregnantSurvey).~   "
66269|NCT02699619|"~     Femoral neck fractures represent about half of the hip fractures and are further divided into~     displaced and undisplaced fractures. Displaced femoral neck fractures are almost always~     treated surgically with arthroplasty. However there is an ongoing debate on which implant is~     superior for undisplaced fractures.~      A novel implant design (Pinloc) has been developed by Swemac Innovation AB. While the~     original implant consisted of 2 isolated hook pins, the modified design consists of 3~     titanium hook pins interlocked in an aluminum plate. Interlocking is a new principle of~     implant design and improves fixation and load transfer amongst the pins. The superiority of~     the modified design is so far only proven preclinically.~      The role of the Pinloc in clinical use remains unclear. Investigators are planning a~     randomized controlled trial on undisplaced femoral neck fractures to establish a method for~     implanting the tantalum markers, to observe the fracture healing process and to further~     investigate the role of the Pinloc.~   "
66270|NCT02699606|"~     The primary purpose of this study is to evaluate objective response rate (ORR) as per~     Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of erdafitinib in a~     molecularly-defined subset of Asian participants with non-small-cell lung cancer (NSCLC),~     urothelial cancer, esophageal cancer and cholangiocarcinoma.~   "
66271|NCT02699593|"~     This is a 4-week, randomized, double-masked study where subjects will wear bilaterally test~     and control lenses in random succession. The objective is to evaluate materials from~     different suppliers.~   "
66272|NCT02699580|"~     This study is to investigate protective effect of biodegradable collagen implant in scleral~     showing after lateral rectus recession in patients with exotropia.~   "
66273|NCT02699567|"~     The purpose of this study is to determine the effect of common human variants in in taste~     related genes, such as CD36 gene, a putative fat taste receptor, affect fat taste perception.~   "
66274|NCT02699554|"~     Impaired neuromuscular control hinders movement for individuals with cerebral palsy and other~     neurological disorders. In this research, the investigators are developing new tools to~     quantify impaired neuromuscular control in cerebral palsy and evaluate changes after one of~     the most common treatments, orthopaedic surgery. The results from this research will empower~     clinicians to identify patient-specific factors that contribute to impaired movement and~     improve treatment and quality of life.~   "
66275|NCT02699541|"~     In this study, researchers will test the effectiveness of a self-management education~     programme, on self-management behaviours of patients with type two diabetes. Up to 230~     consenting participants will be recruited from outpatient diabetes clinics in Jordan, 230~     participants will be randomised to one of two groups. Group 1 ( 115 patients) have received~     the intervention, which consisted of an introductory session of tailored, face-to-face~     education and advice, followed by educational materials to take away, and regular telephone~     support at a regularity specified by the patient, over a three-month period. This~     intervention is based on behavioural change theory called the~     Information-Motivational-Behavioural skills model. Group 2 (115 patients) have received usual~     clinical care with no additional intervention. Researchers have assessed the effectiveness of~     the intervention by measuring self-care strategies (dietary habits, physical activity and~     managing diabetes medications), diabetes control (HbA1c), quality of life and Diabetes~     Self-Management Knowledge, Motivation and Self-Efficacy at 3 time points: before the~     intervention, at 3 months and at 6 months.~   "
66276|NCT02699528|"~     To assess wether methylphenidate reduces the prevalence of primary nocturnal enuresis in~     children with attention deficit disorder~   "
66282|NCT02699450|"~     This is a multiple-center, multiple-dose, randomized, active comparator-controlled,~     double-masked, three parallel group, 36-week study in participants with center-involving~     diabetic macular edema (DME). Only one eye will be selected as the study eye. Where both eyes~     meet all eligibility criteria, the eye with the worse best corrected visual acuity (BCVA)~     will be defined as the study eye. The study will consist of a treatment period (20 weeks) and~     an observational period (up to 16 weeks). Treatment naive participants will be randomized in~     a 1:1:1 ratio to one of the Arms A, B and C, respectively. Participants previously treated~     with intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) will be randomized in~     a 1:1 ratio to Arms A and C.~   "
66283|NCT02699437|"~     The purpose of this study is to determine the prevalence of positive antiphospholipid~     antibodies among women with preeclampsia and to determine the effect of antiphospholipid~     antibodies on the severity of preeclampsia and the obstetric outcomes~   "
66284|NCT02699424|"~     This is an open-label, phase II trial in patients with PSA recurrence after prostatectomy.~     Patients entering the study will all receive initial 50 Gray (Gy) radiotherapy (25 x 2Gy) to~     the prostate bed and thereafter be classified as either responders or non-responders~     depending on PSA response at fifth week of radiotherapy.~      A 68-Ga- PSMA-PET is done before start of radiotherapy, and analyzed before fifth treatment~     week in order to identify cancer lesions in patients with poor PSA response. Patients with~     PSA response after 5 weeks of radiotherapy will not receive any subsequent therapy, whilst~     patients with poor PSA response may be in need for additional therapy such as radiotherapy to~     lymph node metastases and/or boost fractions to local recurrence. Patients with more than 3~     lymph node metastases or distant metastases will not receive any more radiotherapy, but~     individualized systemic therapy will be started.~   "
66285|NCT02699411|"~     We will conduct a randomized clinical trial observing forty patients divided into two groups:~     one group composed of twenty individuals undergoing surgery for ruptured ACL, which perform~     dry needling of myofascial trigger (PGM) point of the vastus muscle and then perform~     techniques proprioception (group a); and twenty patients not be treated with dry needling~     after ACL surgery, using only proprioceptive exercises to the joint (group B).~   "
66286|NCT02699398|"~     The purpose of this study is to determine whether domiciliary VR-based telerehabilitation is~     superior than domiciliary occupational therapy for inducing functional gains, enhancing~     corticospinal excitability, and cortical reorganization.~   "
66287|NCT02699385|"~     The purpose of this study is to demonstrate that domperidone suspension plus oral rehydration~     therapy (ORT) is more effective than placebo plus ORT at reducing the symptoms of vomiting~     associated with acute gastroenteritis (AG) within the first 48 hours of treatment~     administration in pediatric participants with AG and mild-to-moderate dehydration.~   "
66288|NCT02699372|"~     This randomized, single center, adaptive single ascending dose (Part 1) and multiple~     ascending dose (Part 2) study is designed to assess the safety, tolerability,~     pharmacokinetic, and pharmacodynamics following an oral administration of RO6889450 versus~     placebo in healthy volunteers. The anticipated duration of this study is approximately 18~     weeks.~   "
66289|NCT02699359|"~     The HS-1000 is an innovative non-invasive monitoring device that employs advanced acoustic~     signal analysis to calculate ICP on a continuous basis. Initial HS-1000 clinical data also~     shows promise in assessing a variety of cerebral hemodynamic parameters such as cerebral~     blood-flow, auto regulation monitoring, and cerebrovascular vessels compliance. In the~     absence of a non-invasive monitor of intracranial pressure (ICP), the relationships, if any,~     that may exist between concussion, timing of the concussion (e.g. acute, resolving, resolved)~     and ICP is unknown. The new HS-1000 non-invasive device may provide insight into assessment~     of possible ICP changes following concussion in children.~   "
66290|NCT02699346|"~     The HeadSense (HS) HS-1000 device, a new non-invasive brain monitor is expected to safely and~     accurately monitor concussed patients with minimal discomfort, potentially providing a new~     modality for concussion measurement. The device is based on advanced signal analysis~     algorithms that analyze a very low frequency acoustic signal (within the audible range)~     generated by the device. The acoustic signal is transmitted using a small transmitter, placed~     in the participant's ear, and picked by an acoustic sensor placed in the other ear.~   "
66291|NCT02699333|"~     Microscopic colitis is a common cause of watery diarrhea, particularly in the elderly.~     Although the incidence is comparable to ulcerative colitis and Crohn's disease, the etiology~     is unknown. Understanding the etiology of microscopic colitis is an important step in~     developing logical interventions to decrease the burden from microscopic colitis. This~     research could provide critical insights into the etiology of this poorly studied condition.~   "
66292|NCT02699320|"~     There are no reports involved the intestinal microbiota from Chinese infants with short bowel~     syndrome (SBS) under different clinical status. Alterations in the microbiota are closely~     correlated with the bile acids and short chain fatty acids metabolism as well as the~     intestinal immunity. A relatively comprehensive profile composed of microbial structure,~     microbial metabolism products and immune biomarkers in SBS infants may facilitate a better~     therapy strategy to complications occurred in SBS children.~   "
66293|NCT02699307|"~     Physical activity is the cornerstone of good diabetes management, and yet effective physical~     activity intervention is not available. The investigators developed a lifestyle intervention~     based on individual's home activity patterns. The goal of the study is to test the efficacy~     of this intervention among older adults with diabetes. In addition to physical activity, the~     investigators will also assess if the intervention will improve social participation.~   "
66294|NCT02699294|"~     This randomised-controlled trial investigates whether a single intervention of manual~     pressure release combined with stretching exercise has an effect on muscle length, pain~     perception threshold, and respiratory function in subjects with latent myofascial trigger~     point in the pectoralis minor muscle or not. First quarter of the participants will receive a~     single intervention of manual pressure release combined with contract-relax PNF stretching~     exercise of pectoralis minor muscle, second quarter of the participants will receive a single~     intervention of manual pressure release combined with Z stretching exercise of pectoralis~     minor muscle while, only a single intervention of manual pressure release will be applied to~     third quarter of the participants and final quarter of them will not receive any~     intervention.~   "
66295|NCT02699281|"~     Investigators planned to adopt the N-of-1 trial approach to objectively test the~     effectiveness of ultra-micronized PEA at an individual level in our older outpatients. 65~     years old or older persons referring to the Geriatric Unit of the Fondazione IRCSS Ca' Granda~     Ospedale Maggiore Policlinico of Milan complaining of noncancer chronic pain of any origin~     will be eligible. Each trial will be a placebo-controlled randomized crossover trial~     including two um-PEA (600 mg twice a day) and placebo treatment pairs. Investigators will~     secondarily meta-analyse the performed N-of-1 trials to obtain an estimate of the average~     effect of um-PEA compared with placebo using a frequentist and Bayesian approach.~   "
66296|NCT02699268|"~     This is a cross-sectional observational study, aiming to validate the accuracy of tidal~     breathing measurements in infants made by VoluSense Pediatrics, a lung function method based~     on electromagnetic inductance plethysmography, compared to an ultrasonic flowmeter. VoluSense~     Pediatrics consists of a flexible vest placed around the torso of the baby, and changes in~     tidal volume and flow is measured. The study will enable a better understanding of the~     usefulness of this equipment. The equipment is made by VoluSense Norway AS, and is owned by~     Haukeland University Hospital.~   "
66297|NCT02699255|"~     The investigators study aimed to observe the occurrence of new premature ventricular~     complexes and other ventricular arrhythmias after pulmonary vein isolation.~   "
66298|NCT02699242|"~     The aim of the study is to study whether training by residents or anesthesia assistants, on a~     recently introduced virtual-reality bronchoscopic simulator (ORSIM) improves performance of~     fiberoptic intubation in patients.~   "
66299|NCT02699229|"~     For this study the investigators are looking to do the following:~        1. To characterize human lung lesions by nonlinear microscopy using ex vivo tissues.~        2. To establish the first spectral/structural database for nonlinear optical microimaging~          of normal and abnormal lung tissue.~   "
66300|NCT02699216|"~     This study evaluates the treatment of Dry Macular Degeneration and the resulting change in~     vision with a very, very low current that is similar to what occurs in the body naturally. In~     Phase 1, 16 participants will be treated, with half receiving treatment and half a sham (no~     treatment). After the treatment period of one week, those not treated will be treated. In~     Phase 2, all participants will be treated.~   "
66301|NCT02699203|"~     In addition to its role as the major regulator of glucose uptake into peripheral tissues, the~     hormone insulin is also a primary regulator of fat storage and fat burning of the body.~     Mechanistic animal studies have shown that high insulin may be the initial trigger for weight~     gain and be the proximal cause of obesity. There is currently no quick or non-invasive way of~     measuring insulin as research and clinical techniques require collection of a blood sample~     followed by a complicated and costly biochemical assay. The investigators will test the~     hypothesis that insulin levels can be accurately measured in saliva in humans following meals~     that elicit high and low blood insulin responses. Findings will help determine if insulin can~     be use as a valid fluid to track insulin changes in humans.~   "
66302|NCT02699190|"~     The purpose of this study is to establish the ability of Next-Generation Sequencing (NGS)~     technologies to provide a diagnosis in a group of participants with suspected leukodystrophy~     as determined by clinical symptoms, including MRI imaging, but without a specific genetic~     diagnosis. Cost-effectiveness and clinical utility of whole genome sequencing will also be~     investigated as part of the study.~   "
66303|NCT02699177|"~     1. Assessment of a high speed video camera with a green light source for the measurement of~          ciliary beat frequency (CBF) in the nasal airways of patients.~        2. Assessments of the effect of drugs and other therapies on CBF using the study system.~        3. Comparison of results with standard methods such as ciliary brush biopsies~   "
66304|NCT02699164|"~     This study was conducted with the aim of determining whether or not Non surgical spinal~     decompression therapy was effective in remission of herniation, decreasing pain and improving~     functional status.~   "
66305|NCT02699151|"~     Superficial vein thrombosis (SVT) and venous thromboembolism (VTE) are related entities. Only~     in the last years a series of observational studies mainly conducted in France could show~     that ´isolated SVT´ (without concomitant deep vein thrombosis and/or pulmonary embolism) is~     in fact not a benign and spontaneously healing disease but bears a potential for severe~     thromboembolic complications once not treated adequately. INSIGHTS-SVT study aims at~     collecting representative data on the current management and outcomes of SVT in Germany under~     real-life conditions. It will document the implementation of the recently issued national SVT~     guidelines issued by the Society for Angiology (DGA) and the Society for Phlebology (DGP).~   "
66306|NCT02699138|"~     Obstructive sleep apnea (OSA) has traditionally been attributed only to a collapsible upper~     airway. However, it is increasingly recognized that multiple additional non-anatomical~     mechanisms contribute to the disease. Higher rates of OSA in patients with post-traumatic~     stress disorder (PTSD) than in those without PTSD have been reported however the mechanism~     behind this increased prevalence has not been investigated. Our hypothesis is that patients~     with PTSD have a predisposition to OSA due to a lower respiratory arousal threshold (wake up~     too easily) than patients without PTSD. The goal of this project will be to study and compare~     the ArTH in patients with PTSD and those without. In addition, we plan to see whether~     medications can be used to increase the arousal threshold and treat OSA in patients with~     PTSD.~   "
66307|NCT02699125|"~     Patients who have obstructive sleep apnea (OSA) frequently stop breathing while they sleep.~     They often develop high blood pressure. We are not sure what drug is best to treat the high~     blood pressure. This study will give the patients guanfacine or hydrochlorothiazide (HCTZ)~     for 6 weeks after 2 weeks of placebo. The blood pressure response will be evaluated by 24~     hour monitoring.~   "
66308|NCT02699112|"~     To assess patients with hypercapnic respiratory failure using echocardiography,cardiac output~     measurements and markers of neural respiratory drive (EMGpara) prior to, during and after~     non-invasive ventilation (NIV) initiation, and to follow the patients for 3 months. The~     investigators hypothesize that the improvement in cardiac function and/or respiratory~     mechanics over time are associated with ongoing improvements in oxygenation, quality of life~     and exercise capacity.~   "
66309|NCT02699099|"~     The purpose of this study is to assess the immunogenicity, safety, and reactogenicity of the~     SB257049 candidate malaria vaccine when co-administered with Vitamin A, measles, rubella and~     yellow fever vaccines to children aged 6 months at the first vaccination.~   "
66312|NCT02699060|"~     This study is proposed to evaluate the role of motoric dysfunctions and burden of different~     kinds of refluxate on immune cells and the subsequent course of the disease. This study also~     aims to establish a bridge between instrumental findings (pH-impedance test) and clinical~     assessments (FSSG questionnaire), aiming to facilitate the use of simple questionnaire~     techniques in the clinical setting in the future.~   "
66313|NCT02699047|"~     Double-blind, randomized clinical trial to assess the effects of 1,55 g/day of n-3 fatty~     acids from fish oil concomitant chemotherapy in gastrointestinal cancer.~   "
66314|NCT02699034|"~     The purpose of this clinical study is to evaluate the and performance of the Imricor Medical~     Systems, Inc. (Imricor) MR Ablation Catheter when used with related accessories for the~     treatment of type I atrial flutter. The Vision Ablation Catheter and its accessories have~     been designed for use under fluoroscopic or magnetic resonance guidance. The study will be a~     single center study conducted at the Leipzig University Hospital Heart Center in Germany. The~     study population will consist of adult patients requiring ablation for type I atrial flutter.~   "
66315|NCT02699008|"~     High on-treatment platelet reactivity to adenosine diphosphate was a important reason to~     cause ischemic events in antiplatelet therapy. Using single testing to definite HPR may miss~     the true HPR or over estimate HPR, which may lead to randomized trials failed. It is not~     known whether combined multiple platelet function testing could assist to ensuretureHPR and~     improve clinical outcomes.~   "
66316|NCT02698995|"~     Dexamethasone has an evidence-based indication in postoperative emesis prophylaxy and as a~     antiinflammatory steroid. Although the perineural administration is off-label, several~     studies recognised its analgetic action as an adjuvant for peripheral nerves blockade,~     permitting to reduce the concentration of the local anesthetics and extending the sensory and~     motor block.Questions remain concerning the mechanism of action, optimal dose, the~     lack/degree of toxicity and the comparison with intravenous administration.The aim of this~     prospective randomized controlled study is to investigate the efficacy of analgesia with 4 mg~     or 2 mg Dexamethasone added to a combination of ropivacaine 0,5% and lidocaine 1% in vertical~     infraclavicular blockade (VIB) anesthesia for upper limb surgery.~   "
66317|NCT02698982|"~     The aim of this study is to demonstrate that in elderly and frail patients, a narrower~     control of intraoperative blood pressure (BP) by the use of a continuous and noninvasive BP~     monitoring, coupled with an adequate depth of anesthesia, will reduce the incidence of~     postoperative cognitive impairment and the hospital length of stay.~   "
66318|NCT02698969|"~     Diaphragm ultrasonography as a diagnostic tool in order to demonstrate the superiority of~     Sugammadex vs. AChEI in facilitating post-operative neuromuscular recovery.~   "
66319|NCT02698956|"~     This is an international, mutli-center, prospective, consecutively enrolled, observational~     registry. 2000 patients are planned to be enrolled over one year at up to 150 participating~     sites.~      300 patients out of the 2000 patients enrolled in the main registry are planned to be~     consecutively enrolled in a select few sites for studying the valve performance.~     Echocardiogram and angiogram will be taken routinely.~   "
66320|NCT02698943|"~     Posterior capsule opacification (PCO) and glistenings development is among the primary~     reasons for sub-optimal visual capacity following cataract extraction surgery. Primary~     objective of this study is to evaluate the incidence of PCO and glistenings of the popular~     envista MX-60 intraocular lens (Bausch + Lomb) in a random sample of cataract patients who~     underwent phacoemulsification at least 1 year prior to their enrollment at the study~   "
66321|NCT02698930|"~     Acute kidney injury is major complication after open heart surgery. The cause of acute kidney~     injury following open heart surgery is related to activation of sympathetic nervous system,~     decrease of renal blood flow, ischemia-reperfusion injury and systemic inflammatory response.~      Infective endocarditis patients undergoing open heart surgery have systemic inflammatory~     response associated with infective endocarditis. And the inflammatory response can be~     aggravated by cardiopulmonary bypass. The incidence of acute kidney injury following open~     heart surgery due to infective endocarditis was 50% in a previous report. And this acute~     kidney injury was related to the poor outcome and high mortality. Thus, the preventive method~     to protect kidney function will be needed in the patients with infective endocarditis~     undergoing open heart surgery.~      Dexmedetomidine is a selective α2-agonist and has sedative, analgesic, and CNS depressive~     effect. And several experimental study demonstrated the renal protective effect.~     Intraoperative dexmedetomidine administration can reduce the amount of anesthetics needed and~     suppress the sympathetic response resulted by surgical stimulation. And dexmedetomidine was~     reported to reduce the level of serum cortisol, epinephrine and norepinephrine during the~     operation. Thus, these effects of dexmedetomidine can be expected to reduce the incidence of~     acute kidney injury.~      Therefore, the investigators hypothesized that dexmedetomidine has renal protective effect~     and this effect might be related to the suppression of inflammatory response. Thus, the~     investigators will evaluate the incidence of acute kidney injury and the incidence of major~     adverse kidney events (MAKE) after open heart surgery due to infective endocarditis and the~     level of inflammatory mediators.~      The primary end point of this study is the incidence of acute kidney injury after open heart~     surgery due to infective endocarditis. And secondary end point is the incidence of MAKE, the~     level of cystatin C which is related to the renal function, the level of inflammatory~     mediator and the postoperative morbidities.~   "
66322|NCT02698917|"~     The COMACARE trial is a pilot multicenter randomized trial to assess the feasibility and~     effect on brain injury markers of targeting low or high normal arterial oxygen tension~     (PaO2), arterial carbon dioxide tension (PaCO2) and mean arterial pressure (MAP) in comatose,~     mechanically ventilated patients after out-of-hospital cardiac arrest. Using factorial~     design, participants are randomized at admission to intensive care unit to one of eight~     groups targeting either low or high normal values of PaO2, PaCO2 and MAP for 36 h. In this~     way, investigators will be assessing the feasibility and effect of all three variables at the~     same time.~      The primary outcome is serum concentration of neuron-specific enolase (NSE) at 48 h after~     cardiac arrest. Feasibility outcome is between-group separation in PaO2, PaCO2 and MAP~     levels. Secondary outcomes include continuous monitoring of cerebral oxygenation, EEG and ECG~     for 48 h, the levels of NSE, S100B and cardiac troponin at randomization and 24, 48 and 72 h~     after cardiac arrest and neurological assessment at 6 months after cardiac arrest.~   "
66323|NCT02698904|"~     People with Chronic Obstructive Pulmonary Disease (COPD) suffer from dyspnoea, which may be~     exacerbated by psychological outcomes including anxiety and depression. Previous studies~     suggest that relaxation techniques may have positive effects on pulmonary rehabilitation. The~     main aim of this study is to explore both the respiratory and psychological impact of a~     quick, one-session, relaxation training for people with Chronic Obstructive Pulmonary Disease~     (COPD).~   "
66324|NCT02698891|"~     This research study is testing the safety and feasibility of delivering the 4 cycles of~     'dose-dense' paclitaxel without the use of Neulasta (Pegfilgrastim) as a Granulocyte~     Colony-stimulating Factor (G-CSF) support. The research study is for participants who have~     early stage breast cancer and have been recommended to receive a standard chemotherapy~     regimen, doxorubicin/cyclophosphamide (AC) plus Paclitaxel (T), in what is called a~     dose-dense fashion to prevent recurrences.~   "
66326|NCT02698852|"~     PIONEER-II OPC trial is a prospective, multicenter, single-arm registry trial. 1000 subjects~     from approximately 40 interventional cardiology centers will be enrolled to evaluate the~     target lesion failure(TLF) as the primary endpoint at 1 year. And all the subjects will be~     followed up to 5 years to attain the data of the secondary endpoints.~   "
66327|NCT02698839|"~     PIONEER-II RCT trial is a prospective, multicenter, randomized, non-inferiority registry~     trial. 539 subjects from about 40 interventional cardiology centers in China will be enrolled~     to evaluate In-stent late lumen loss(LLL) as the primary endpoint at 9 months. And all the~     subjects will be followed up to 5 years to attain the data of the secondary endpoints.~   "
66328|NCT02698826|"~     The broad objective of this study is to test the association between hyperoxia exposure after~     resuscitation from cardiac arrest and outcome. After obtaining written informed consent~     subjects enrolled in REOX II will undergo a rapid faction of inspired oxygen (FiO2)~     optimization protocol to prevent exposure to hyperoxia. We will compare outcomes between~     subjects enrolled in REOX I (observational study only) and REOX II (intervention: rapid FiO2~     optimization protocol). Our overarching hypothesis is that exposure to hyperoxia after return~     of spontaneous circulation (ROSC) is associated with increased oxidative stress and worsened~     neurological and cognitive outcomes.~   "
66329|NCT02698813|"~     The overall goal of this study is to evaluate the safety and exploratory efficacy of the~     injectable filler agent composed of umbilical cord mesenchymal stem cells and hyaluronic acid~     for the improvement of wrinkles, acne, pitting scar and so on.~   "
66330|NCT02698800|"~     Under entrained conditions, humans maintain a consolidated nocturnal sleep episode that~     coincides with environmental darkness and endogenous melatonin secretion. Various factors,~     such as artificial light, can compromise this temporal harmony, resulting in sleep~     disruption. Light is the strongest synchronizer of the circadian clock, with direct inputs~     via the retinohypothalamic tract to brain centers regulating sleep and circadian rhythms.~     Evening light exposure can suppress melatonin secretion and worsen sleep. This is critical,~     since most individuals routinely expose themselves to light before bedtime. The high~     sensitivity of the circadian system to blue wavelength light indicates that modern light~     sources such as light-emitting diodes (LED) may have particularly deleterious effects on~     sleep. It is possible to selectively filter out blue light while maintaining other visible~     spectra with blue-blocking (BB) lenses. Wearing BB lenses before bedtime may present a~     simple, affordable, and safe method to improve sleep. None have yet investigated the effects~     of BB lenses on subjective and objective sleep in insomnia patients, while simultaneously~     exploring the effects on melatonin secretion.~   "
66331|NCT02698761|"~     Sickle cell disease (SCD) is the most common inherited blood disorder affecting 80,000 to~     90,000 individuals in the United States.[10] There are 13,000 hospital admissions for a~     sickle cell crises, costing $448 million dollars annually.[10] In our hospital, the sickle~     cell population is known to have some of the longest length of stays. Between October 2014~     and September 2015, there were 89 admissions for a vaso-occlusive crisis with an average~     length of stay of 6 days and 12 admissions greater than 10 days and 5 admissions greater than~     20 days.~      We propose to evaluate the feasibility of the new CPP in a pilot randomized control trial to~     determine if pain and length of stay can be reduced in patients with sickle cell disease. We~     also propose to evaluate a sleep regimen to determine if this can reduce the hospital stay~     and help with pain. We hypothesize increased physical activity and proper sleep, as~     implemented in the CPP, are correlated with decreased hospital length of stay and decreased~     pain. Additionally, we believe that creating a standardized nighttime environment at the~     hospital will help the children stay in their circadian rhythm thus promoting improved sleep~     and a more effective inpatient disease management.~   "
66332|NCT02698748|"~     One of the proposed ideas for malaria elimination includes the use of drugs to interrupt~     malaria transmission by exhausting the human reservoir of infection. Theoretically, mass~     treatment of an entire population with a very effective and rapid-acting drug (for instance~     an ACT), followed by the administration of an effective prophylactic regime during a minimum~     of four weeks, so as to outlast the typical development period of Plasmodium parasites in~     Anopheline mosquitoes, could achieve the same objective. In this respect, chloroquine (CQ)~     would be an appropriate candidate. This drug exhibits two conditions that make it attractive~     for elimination campaigns: 1) It has been demonstrated to have an excellent safety profile,~     allowing for its use in all age groups including pregnant women and children; and 2) Its~     relatively long elimination half life (t1/2=1-2 months) can provide a long post-treatment~     prophylactic effect. Recent evidence suggests that CQ sensitivity may be returning in places~     where discontinuation has reduced the drug pressure to the parasite populations. In countries~     such as Malawi, P. falciparum seems to have regained full sensitivity to CQ, and molecular~     markers of antiCQ resistance have nearly disappeared. While this does not support the~     reintroduction of CQ as first line therapy, it does suggest that, if proven sensitive in a~     given area, it could play a prophylactic role in malaria elimination strategies when used in~     combination with other drugs or tools. Thus, we intend to evaluate the potential role of~     chloroquine in preventing infections during elimination campaigns by performing a randomized,~     single-blind, placebo-controlled trial in asymptomatic Mozambican adults.~      Choosing asymptomatic parasitaemic adult males from a malaria-endemic area as our study~     population introduces limited risks when administering a drug with an uncertain efficacy (47%~     efficacious in 2001-2002). In malaria-endemic areas, this age group has a remarkably low risk~     of developing severe disease (irrespective of clinical symptoms), and it is foreseeable that~     parasitemia may be well tolerated, and in certain cases, spontaneously cleared from the~     individual's blood as a result of the immune system. In the unlikely event of any clinical~     symptomatology appearing throughout the follow-up, individuals will be examined by a study~     clinician and treated immediately with the country's first-line malaria treatment~     (artemether-lumefantrine, Coartem ®).~   "
66333|NCT02698735|"~     Recessive dystrophic epidermolysis bullosa (RDEB) is an incurable, devastating, inherited~     skin disease for which there is only supportive care. RDEB is due to mutations in COL7A1 gene~     that encodes for type VII collagen (C7), the major component of anchoring fibrils (AFs)~     mediating epidermal-dermal adherence. Approximately 20% of COL7A1 mutations are nonsense~     mutations leading to premature stop codons and a truncated C7 with diminished function. The~     investigators demonstrated that aminoglycosides such as gentamicin readily induce premature~     termination codon (PTC) read through and produce biologically functional C7 in 22 reported~     COL7A1 nonsense mutations. Importantly, aminoglycoside-induced C7 reversed the abnormal RDEB~     cell phenotype and incorporated into the dermal-epidermal junction. Herein, the investigators~     propose the first clinical trial of gentamicin (topical and intradermal) in RDEB patients~     with nonsense mutations that the investigators have fully characterized. The milestones~     include increased C7 and AFs at the patients' dermal-epidermal junction, improved RDEB~     Disease Activity Score, and absence of significant gentamicin side effects.~   "
66334|NCT02698722|"~     In the United States, it is estimated that there are approximately 630,000 patients who have~     ESRD with two-thirds of those patients subsequently receiving maintenance dialysis. Studies~     have demonstrated that the initiation and timing of dialysis for those with ESRD seem to vary~     widely regionally - confirming the uncertainty of the benefits of chronic dialysis in this~     population~      Pre-dialysis education programs inform patients of all of their options allowing them to~     choose renal replacement therapy that is most consistent with their wishes. Recent evidence~     has supported using different methods of delivering education including videos to complement~     standard clinical care practices to promote informed decision making. This proposed study~     will serve to examine the effectiveness of a dialysis modality video decision support tool to~     inform chronic kidney disease patients of different dialytic and non-dialytic therapies.~   "
66335|NCT02698709|"~     The main purpose of this study is to determine new diagnostic criteria for an eye disease~     called keratoconus.~   "
66336|NCT02698696|"~     This study evaluates the effect of a new cognitive remediation program designed for patients~     suffering from a bipolar disorder, on cognitive functions, psychosocial functioning and~     neural processes. In this double-blind (patient, outcomes assessor) controlled randomized~     trial the investigators compare patients receiving the ECo program for bipolar disorders, to~     patients benefiting from the broadly used cognitive remediation program CRT and to patients~     receiving supportive psychotherapy. Patients are treated for 3 months and monitored for 9~     months.~   "
66337|NCT02698683|"~     Participants were classified as normal or malnourished according to anthropometric measures.~     Serum albumin and zinc were recovered on the 1st and 7th days of hospitalization. Lymphocyte~     count was also recorded on the 1st and 7th days.~   "
66338|NCT02698670|"~     This is an observational, prospective, non-randomized, multicenter, post approval study being~     conducted in the United States, Europe and Asia-Pacific Regions.~   "
66339|NCT02698657|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of~     multiple ascending intravenous doses of ASP5094 in male and female subjects with rheumatoid~     arthritis (RA) on methotrexate (MTX).~   "
66340|NCT02698644|"~     Is to assess the effectiveness of hysteroscopic tubal application of Iso Amyl-2-cyanoacrylate~     in occluding uterine tubes of women, which would make it an easy approach for occluding tubes~     with hydrosalpinx prior to IVF and in tubal sterilization.~   "
66341|NCT02698631|"~     The ALICIA-FA study will elucidate whether targeting atrial myocardial fibrosis identified by~     late gadolinium-enhanced magnetic resonance imaging (LGE-MRI) improves atrial fibrillation~     (AF) ablation outcomes.~   "
66342|NCT02698618|"~     The purpose of this study is to determine whether Ticagrelor has a protective effect on~     microcirculation during percutaneous coronary interventions in patients with Diabetes~     mellitus type II or in a pre-diabetic status.~   "
66343|NCT02698605|"~     The usability assessment focuses on the actual use of the proposed rehabilitation system to~     clarify issues users would face in actual system operation, thus providing a reference for~     subsequent system improvement.~   "
66344|NCT02698592|"~     The purpose of this study is to determine whether the Thermocool SF ® system is at least as~     effective and safe as regular 8mm catheters and irrigated tip catheters in the treatment of~     cavo-tricuspid isthmus dependent atrial flutter.~   "
66345|NCT02698579|"~     This is a multi-center, long-term safety and efficacy follow-up study for subjects with~     cerebral adrenoleukodystrophy (CALD) who have received Lenti-D Drug Product in Study ALD-102.~      After completing Study ALD-102 (approximately 2 years), eligible subjects will be followed~     for an additional 13 years for a total of 15 years post-drug product infusion. No~     investigational drug product will be administered in this study.~   "
66346|NCT02698566|"~     This is a multicenter study designed to evaluate usability of ranibizumab PFS in patients~     with neovascular age related macular degeneration or macular edema secondary to retinal vein~     occlusion.~   "
66347|NCT02698553|"~     Bupropion is used in psychological disorder mainly in major depressive disorder (MDD). In~     China, buproprion Immediate Release (IR) and Sustained Release (SR) tablet have been in~     market for the treatment of MDD. Bupropion Hydrochloride (HCl) Extended Release (XL) tablets~     formulation is proposed for marketing approval in China for same indication. Therefore, a~     pharmacokinetic study is planned to be conducted in Chinese subjects. It is an open label,~     single-centre and single cycle study to evaluate the pharmacokinetics, safety and~     tolerability of 150 milligram (mg) and 300 mg following single and repeated daily doses.~     Approximately 16 males and females Chinese healthy subjects will be enrolled into the study~     to get 12 completed subjects.~   "
66348|NCT02698540|"~     The purpose is to observe the compliance to a high-calorie, high protein peptide-based~     nutritional supplement after 3 months in a malnourished population with impaired~     gastrointestinal tolerance living in nursing homes and as outpatients.~   "
66349|NCT02698527|"~     Objective: To compare pain scores on a visual analogue scale during infiltration of local~     anesthetic for vulvar biopsies between women who are treated with buffered versus non-~     buffered lidocaine~      Hypothesis: Patients treated with buffered lidocaine at the site of vulvar biopsy will have~     lower pain scores on a visual analogue scale during the biopsy.~      Study Design: Double blinded randomized controlled trial~      Population: Women undergoing vulvar biopsy at the Women's Primary Care Center and The Program~     In Women's Oncology Clinic of a non-infectious vulvar lesion.~   "
66350|NCT02698514|"~     The aim of this clinical trial is to evaluate the ratio of hypnotic to analgesic potency of~     sevoflurane and desflurane at equi-minimum alveolar concentration using SPI and EEG analysis.~   "
66351|NCT02698501|"~     The purpose of this study is to determine whether anti-TSLP will decrease airway~     hyperresponsiveness in patients with asthma already on daily treatment with inhaled~     corticosteroids.~      The investigators expect that airway hyperresponsiveness will decrease after treatment with~     anti-TSLP, and that this happens due to a change in the type of mast cells with in the lungs.~     Also, the investigators expect a decrease in inflammatory cells and mediators measured in~     material from the lungs.~      Half of the participants will receive anti-TSLP (MEDI9929) on top of their regular asthma~     treatment, while the other half will receive placebo on top of their regular asthma~     treatment.~   "
77899|NCT02547363|"~     The objective of the trial is to compare the short term efficacy of LEO 43204 gel with~     vehicle gel in AK on the balding scalp when applied topically once daily for 3 consecutive~     days as field treatment.~   "
66352|NCT02698488|"~     Identification of the embryo with the highest potential to implant and establish an ongoing~     pregnancy is a primary aim in human assisted reproduction. This task is undertaken every day~     by embryologists worldwide during the treatment of couples that wish to conceive by IVF. The~     optimal scenario is the transfer of a single embryo which gives rise to a singleton~     pregnancy. The current limitations in determination of embryos that have the highest~     implantation potential probably contribute to the low rates of pregnancy during IVF~     treatments. Hence, since the beginning of IVF, how to improve embryo selection has been a~     'hot research topic.' Morphology has been a very obvious parameter to assess embryos as it~     provides a chance to evaluate them from the oocyte stage all the way to the blastocysts~     stage. Hence, in the first era of IVF, there were number of studies that evaluated this~     parameter and associated morphology with IVF success rates. On the other hand, it has been~     previously stated that the slight increase in pregnancy rates during IVF treatment is mostly~     likely a result of better practices in laboratory than morphological evaluation. Due to the~     limitations of morphological evaluation, several researchers have investigated adjunctive~     non-invasive approaches for the assessment of the embryo, such as the metabolomic profiling.~      Recently mass spectroscopic (MS) approaches have been utilized in limited settings. Samples~     needed minimal preparation; analytical analysis was rapid and large amounts of data was~     available. Hence, MS might be a promising approach for metabolomic profiling of embryo~     culture media.~   "
66353|NCT02698475|"~     The purpose of this study is to evaluate the efficacy and safety of ustekinumab in pediatric~     participants aged greater than or equal to (>=) 6 through less than (<) 12 years with~     moderate to severe chronic plaque psoriasis~   "
66354|NCT02698462|"~     The aim of this study is to identify more persons with advanced neoplasia in the current~     national CRC screening, by adding data on family history of CRC (using a validated online~     questionnaire) to FIT. In addition, the aim is to identify those persons and their family~     members who should not be participating in a FIT based screening but receive surveillance~     colonoscopies instead, because of a familial CRC syndrome. It is aimed to increase detection~     without affecting participation, thereby increasing the yield of screening.~   "
66355|NCT02698449|"~     The current study aims to better understand cerebral plasticity mechanisms to optimize~     non-pharmacological rehabilitation approaches for patients with traumatic brain injury.~   "
66356|NCT02698436|"~     This study will compare two different acne treatments for the treatment of acne. Half of the~     participants will receive two marketed acne products (cleanser and leave-on topical~     treatment), while the other half of the participants will receive a marketed cleanser and a~     light-therapy device.~   "
66357|NCT02698423|"~     The purpose of this study is to determine whether human-papillomavirus (HPV) self-sampling~     can be used as a primary screening test for unscreened women.~   "
66358|NCT02698410|"~     The purpose of the protocol is to evaluate the efficacy and safety of Lanreotide ATG 120 mg~     in combination with Temozolomide in subjects with unresectable advanced neuroendocrine~     tumours of the lung or thymus as Disease Control Rate at 9 months.~   "
66359|NCT02698384|"~     The study aims to evaluate the biochemical and clinical effectiveness on symptoms and tumor~     size of a monotherapy with Lanreotide 120mg in acromegalic subjects, to describe criteria for~     starting alternative strategies, and to describe the modalities and the global effectiveness~     of alternative strategies.~   "
66360|NCT02698371|"~     The purpose is to evaluate/compare clinical effectiveness of dual cure (DC) all-in-one~     Self-Etch (Futurabond® DC (FBDC)) adhesive and multimode/universal (Futurabond® U (FU) and~     Adhese® Universal (AU)) adhesives, with or without selective enamel etching, in non-carious~     cervical lesions (NCCL), during 24th months, using Word Dental Federation (FDI) and United~     States Public Health Services (USPHS) criteria.~      The null hypotheses are:~      H0 - Bonding to NCCLs with DC-SE and SE-Universal adhesives with SE strategies will result in~     similar (no significant differences) clinical (aesthetic, functional and biologic)~     behaviour/performance in a period of 24th month evaluation; H0 - Bonding to NCCLs with DC-SE~     and SE-Universal adhesives with SE strategies will result in similar restorations (aesthetic,~     functional and biologic) success rates over 24th month evaluation; H0 - Bonding to NCCLs with~     DC-SE and SE-Universal adhesives with SE strategies will result in similar restoration~     retention rates in a period of 24th month evaluation; H0 - Bonding to NCCLs DC-SE with enamel~     pre-etching and Universal adhesives with ER adhesive strategy will result in similar (no~     significant differences) clinical (aesthetic, functional and biologic) behaviour/performance~     in a period of 24thmonth evaluation; H0 - Bonding to NCCLs DC-SE with enamel pre-etching and~     Universal adhesives with ER adhesive strategy will result in similar restorations (aesthetic,~     functional and biologic) success rates over 24th month evaluation; H0 - Bonding to NCCLs~     DC-SE with enamel pre-etching and Universal adhesives with ER adhesive strategy will result~     in similar restoration retention rates in a period of 24th month evaluation; H0 - Bonding to~     NCCLs with FBDC or FU (DC adhesives) and AU (Light-curing adhesive) with SE or ER adhesive~     strategies will result in similar (no significant differences) clinical (aesthetic,~     functional and biologic) behaviour/performance in a period of 24th month evaluation; H0 -~     Bonding to NCCLs with FBDC or FU (DC adhesives) and AU (Light-curing adhesive) with SE or ER~     adhesive strategies will result in similar restorations (aesthetic, functional and biologic)~     success rates over 24th month evaluation; H0 - Bonding to NCCLs with FBDC or FU (DC~     adhesives) and AU (Light-curing adhesive) with SE or ER adhesive strategies will result in~     similar restoration retention rates in a period of 24th month evaluation; H0 - FDI or USPHS~     criteria evaluation outcomes not differ for the same data.~   "
66361|NCT02698358|"~     -  Prospective, single-arm, multi-center registry study~        -  A total of 150 subjects with iliac artery disease who meet all inclusion and exclusion~          criteria will be included.~        -  Patients will be followed clinically for 12 months after the procedure.~        -  Duplex ultrasound, CT or catheter-based angiography follow-up according to participating~          hospital's protocol will be performed at 12 months.~        -  Presence of stent fracture will be evaluated by plain radiography or fluoroscopy at 12~          months.~        -  Quality of life by standardized questionnaires (at baseline & at 1 & 12 months)~   "
66362|NCT02698345|"~     -  Prospective, multi-center, single-arm registry study~        -  A total of 100 subjects with isolated popliteal artery lesions according to inclusion~          and exclusion criteria will be enrolled.~        -  All popliteal artery lesions will be treated with drug-eluting balloon (In.PACT Admiral,~          Medtronic). • Atherectomy or use of bare nitinol stent in combination with drug-eluting~          balloon is allowed • Patients will be followed clinically for 12 months after the~          procedure.~        -  Imaging study (Duplex ultrasound, CT angiography or catheter angiography) follow-up will~          be performed at 12 months.~   "
66363|NCT02698332|"~     The aim of this study is to investigate the effect of diagnostic algorithm for urinary tract~     infection (UTI) on appropriate prescribing of antibiotics and use of diagnostics for patients~     with symptoms of urinary tract infection consulting their general practitioner.~      70 general practices participating in an observational study regarding UTI are randomized to~     either receiving a diagnostic algorithm or not receiving anything additional.~      The study is observational on the patient level and interventional on the practice level.~   "
66364|NCT02698319|"~     Crowding in the emergency department (ED) is a well documented problem putting patients at~     risk of adverse outcomes. To combat this, most ED's use some form of triage. In the last two~     decades systematic triage or process triage has become the norm in most countries but this~     approach is supported by limited evidence. Our aim is to develop a faster triage model of~     only a few vital parameters, based on a data from a large cohort of unselected ED patients~     and evaluate if such a model combined with a clinical assessment by the ED nurse is inferior~     to existing triage models in a prospective cluster-randomized trial~   "
66365|NCT02698306|"~     The investigators will select 30 patients with symmetrical impaction of third molars,~     according to Pell and Gregory dental impaction classification, who would be submitted to two~     surgical procedures, right and left, and in both surgeries dexamethasone 8 mg was~     administered in the pre-surgery phase, and the use of dexamethasone (12 mg/day) for 3 days on~     one side and diclofenac sodium (150 mg/day) for 3 days on the other side was continued, in a~     randomized, double-blind and cross-over trial so that all patients acted as control of~     themselves (split-mouth). Other drugs used in postoperative period, rescue analgesic and~     antibiotic therapy will be identical for all patients. The analyzed variables will be the~     visual analogue pain scale (VAS), total number of consumed analgesics, swelling and trismus~     (objectively), which were statistically analyzed by means of Student's t-test.~   "
66366|NCT02698293|"~     This is a phase I dose escalation study of photodynamic therapy (PDT) for the treatment of~     patients with pre-malignant tumors and superficial microinvasive disease of the anal canal~     and/or perianal skin. All subjects (a maximum of 12) will be given the photosensitizer~     Gliolan orally followed by the administration of red light (629-635 nm) to the tumor from a~     laser. The dose of Gliolan will be 40 mg/kg administered approximately 4-6 hours before light~     administration. There will be two levels of light dose: 50 and 100 J/cm2, 3-6 patients in~     each. Patients will be observed for 30 days for the development of DLT. Patients will be~     followed up for 24 months for additional toxicity and efficacy data collection.~   "
66367|NCT02698280|"~     The purpose of this study is to determine whether bevacizumab and nimustine are effective in~     the treatment of recurrent high grade glioma and to explore whether there is any subgroup~     being sensitive to this therapeutic protocol.~   "
66368|NCT02698267|"~     The primary objective of the study is to assess the effect of cytochrome P450 (CYP) 3A4~     inhibition on the pharmacokinetics (PK) of BIIB074. The secondary objectives of this study~     are to assess the safety and tolerability of BIIB074 when co-administered with a strong~     CYP3A4 inhibitor and to assess the effect of CYP3A4 inhibition on the PK of 3 metabolites of~     BIIB074 (CNV3000497 [M13], CNV2283325 [M14], and CNV2288584 [M16]).~   "
66369|NCT02698254|"~     The goal of this clinical research study is to test the safety of repeat radiation for brain~     tumors that came back after the first course of radiation. Researchers also want to learn how~     repeat radiation affects your quality of life.~      This is an investigational study. Radiation will be provided according to routine clinical~     standards using FDA-approved and commercially available methods. The use of a second course~     of radiation is investigational.~      Up to 40 participants will be enrolled in this multicenter study. All will take part at MD~     Anderson.~   "
66370|NCT02698241|"~     The INTERVENE-HF study is a prospective, non-randomized, multi-center (US only),~     investigational, feasibility study. The purpose of this study is to characterize safety of~     managing heart failure patients with integrated device diagnostics that have an implanted~     commercially available Medtronic cardiac resynchronization therapy defibrillator (CRT-D).~   "
66371|NCT02698228|"~     The goal of the RAPID study is to fundamentally transform the way serious injuries are~     managed after earthquakes and other disasters by introducing a novel and cost-effective~     method for pain control. The study will enroll patients in the aftermath of a major~     earthquake to determine whether regional anesthesia, either with or without~     ultrasound-guidance, can reduce suffering from lower limb injuries, the most common~     earthquake-related injury, above and beyond the current standard of care for pain control in~     these settings.~   "
66372|NCT02698215|"~     This study is a double-blind, randomized clinical trial using a two group medication design~     consisting of the combination of VAR (1 mg twice daily) + NTX (50 mg once daily) and VAR (1~     mg twice daily) + PLA (matched to NTX), for smoking cessation in a sample of heavy drinking~     daily smokers who want to quit smoking and reduce drinking.~   "
66373|NCT02698202|"~     Randomized trial comparing the performance of tomosynthesis and 2D Digital Mammography vs 2D~     Digital Mammography only in respect to incidence of advanced cancers (interval and following~     round) and interval cancers.~   "
66374|NCT02698189|"~     This is a study to determine the recommended dose of MK-8628 for further studies in~     participants with acute myeloid leukemia (AML) including AML de novo and AML secondary to~     myelodysplastic syndrome (MDS) and in participants with diffuse large B cell lymphoma~     (DLBCL). The recommended dose will be established by evaluating dose limiting toxicity (DLT),~     safety, tolerability, and early efficacy signals.~   "
66375|NCT02698176|"~     This is a study to determine the recommended dose of MK-8628 (formerly known as OTX015) for~     further studies in participants with advanced nuclear protein in testis (NUT) midline~     carcinoma (NMC), triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), or~     castration-resistant prostate cancer (CRPC). This is a two-part parallel study: Part A will~     establish the recommended dose by evaluating dose limiting toxicity (DLT), safety,~     discontinuation, and early efficacy and Part B will enroll participants with NMC only and~     will evaluate safety and efficacy in this population.~   "
66376|NCT02698163|"~     Non-surgical root canal therapy (RCT) represents a standard of treatment that addresses~     infected pulp tissue in teeth and protects against future infection while preserving the~     tooth for the patient for mainly cosmetic purposes. RCT is offered as the better cosmetic,~     cheaper, and less time intensive treatment option for a patient compared to those of dental~     implantation. Dental implantation is the alternative to RCT, and they are both originally~     offered at the time of the initial consultation. RCT involves non-surgically removing dental~     pulp comprising blood vessels and nerve tissue, decontaminating residually infected tissue,~     and using a filler material to replace the non-surgically created space where the pulp was~     removed. Currently, standard of care treatment for RCT utilizes gutta-percha as the root~     canal filling material. Our research group has previously demonstrated NDGP's improvement in~     tensile strength compared to those of gutta-percha. This research studies a new type of~     filler, gutta-percha modified by the addition of nanodiamond material (NDGP). This is an~     equivalence study of NDGP and standard gutta-percha administration.~   "
66377|NCT02698150|"~     HERMES is a pilot study which aims at exploring the impact of remote monitoring in patients~     with severe functional mitral regurgitation undergoing transcatheter mitral valve~     edge-to-edge repair with the Mitraclip system.~   "
66434|NCT02697396|"~     This project aims to raise awareness and improve HPV vaccination rates among children of~     Mexican American parents through the implementation of a tailored social marketing campaign~     which includes text messaging reminders.~   "
66378|NCT02698137|"~     The investigators will prospectively collect patient and procedure-related data in an~     observational study in order to detect patient and procedure-related risk factors for poor~     outcome (i.e. technical failure of the procedure; procedure-related complications).~      Data will be prospectively reported using standard report forms and patients will be followed~     up to 30 days to detect late-onset complications.~   "
66379|NCT02698124|"~     Prospective multicenter, open-lab el, observational, single arm study of decitabine. Subjects~     will be elderly patients with newly diagnosed, treatment-naïve AML who are unfit to receive~     and not candidate for intensive induction chemotherapy (iIC)~   "
66380|NCT02698111|"~     The investigators do the clinical trial (patients with metastatic nasopharyngeal carcinoma~     treated with donafenib after failure of standard therapy) to assess safety and efficacy of~     donafenib in patients with metastatic nasopharyngeal carcinoma, progressing after all~     approved standard therapies.~   "
66381|NCT02698098|"~     This observational study compares the health and social outcomes between opioid-dependent~     individuals who are either recently released from a compulsory drug detention center (CDDC)~     or recently discharged from a voluntary treatment center (VTC) providing methadone~     maintenance therapy, in Malaysia.~   "
66382|NCT02698085|"~     Diacutaneous Fibrolysis is a manual method of treatment, addressed to mechanical pain of the~     neuromusculoskeletal system. In the clinical practice a favorable effect is observed in~     patients with carpal tunnel syndrome, but there is no published studies evaluating the~     results os this technique.~      The objective of this trial is to evaluate if Diacutaneous Fibrolysis is more effective in~     symptoms, function, grip, mechanosensitivity and neural conduction velocity compared to a~     placebo.~      For this purpose the investigators conduct a randomized controlled trial double-blind~     (patient and examiner). The investigators included patients diagnosed of carpal tunnel~     syndrome (low to moderate intensity) with a neurophysiological test.~      Patients included are randomized into 2 groups one receive Diacutaneous Fibrolysis and the~     other placebo. Both groups receive 5 treatment sessions.~      The variables are measured at the beginning and end of treatment. And also some variables are~     measured before and after each session. Patients who participated in placebo group, when the~     intervention finish the investigators will be given the opportunity to receive the actual~     technique~   "
66383|NCT02698072|"~     This study evaluates the combination of a therapeutic exercise program and dry needling in~     the treatment of knee osteoarthritis in older adults. Half of participants will receive~     therapeutic exercise program and dry needling in combination, while the other half will~     receive the same therapeutic exercise program and sham dry needling.~   "
66384|NCT02698059|"~     This is a post-marketing surveillance study to investigate the efficacy and safety of the~     Negative Pressure Sleep Therapy System for the treatment of obstructive sleep apnea.~   "
66385|NCT02698046|"~     This study is design to evaluate the effectiveness of oral iron therapy in patients with~     heart failure and identify the central and peripheral mechanisms involved in the improvement~     of functional capacity after intervention. The investigation includes subjective and~     objective measures on exercise performance and heart function after intervention, and the~     tolerability of oral iron treatment.~   "
66386|NCT02698033|"~     This protocol is designed to better characterize a sub-population of peanut sensitized~     individuals who may be non-allergic, despite significant sensitization, or who may be~     allergic, but at high threshold doses. By specifically targeting participants who met the~     initial screening criteria of the active adult PN OIT study, Protocol 2012p002153 / AADCRC~     MGH-004 (MGH-004), but failed to react during the pre-treatment 443 mg challenge to peanut,~     the investigators anticipate that the investigators will identify individuals who have become~     spontaneously tolerant, despite persistent sensitization. The investigators might also find~     that clinical sensitivity persists but only with higher thresholds, or that sensitivity has~     increased (or is variable) since the previous allergen exposure. By repeating DBPCFCs through~     to a full serving dose (7.4 gram), the investigators will distinguish participants who react~     only at higher doses from those who were not truly peanut allergic, address whether their~     sensitivity has changed, and have the opportunity to further investigate their immune~     response to peanut allergen.~   "
66387|NCT02698020|"~     An open randomized control trial investigating the delivery of two levels of inspired oxygen~     to newborn infants during general anesthesia.~   "
66388|NCT02698007|"~     Bronchoscopy is a method of diagnosis and treatment of common respiratory diseases and lung~     recognized for many years.~      Since the action takes place in the airways and in light of the use of sedation, when~     performing, the procedure requires caution to keep potent airway and breathing sufficient~     enough.~      Most of the bronchoscopy done without the aid of equipment for advanced airway protection.~     During the operation done monitoring hemodynamics: such as blood pressure, pulse and~     respiratory such as percutaneous oxygen saturation and carbon dioxide.~      Laryngeal Mask Airway (LMA) - is a tool that has been shown to be effective in securing of~     airway respiratory activity during positive-pressure ventilation.~      Several studies have shown that the use of LMA is a convenient and safe while performing~     bronchoscopy for airways and lungs. However, most of the studies were for certain patient~     groups such as children, immuno-compromised patients.~      Or benefits and safety LMA in front of intubation during bronchoscopy.~      Our aim to assess the safety and efficacy LMA in not mechanically ventilated patients~     undergoing flexible elective bronchoscopy .~      Another objective, to examine whether there is a special group of patients enjoy the LMA more~     than others.~      Patients will be divided randomly into two groups alternately by order, one patient study~     group and the next one to control.~      Study group : LMA is inserted under sedation and used during the procedure.~      Control group - performing bronchoscopy under sedation without LMA.~      About 50 people are needed each group.~   "
66400|NCT02697851|"~     This study will investigate the pharmacokinetic of evotaz (atazanavir/cobicistat) and~     microgynon (ethinylestradiol/levonorgestrel ) when administered alone and together. There~     will be two study arms, who will take the medications in different orders:~      GROUP 1: Microgynon 30® for 21 days, Followed by Microgynon 30® for 21 days plus Evotaz® for~     14 days, Followed by Evotaz® for 14 days GROUP 2: Evotaz® for 14 days followed by 7 days~     wash-out, Followed by Microgynon 30® for 21 days plus Evotaz® for 14 days, Followed by~     Microgynon 30® for 14 days (participants may chose to complete a 21 day pack). The total~     duration of the study is 57 days (+screening and follow up visits) and patients will have 3~     intensive pharmacokinetic days on days 14, 35 and 56.~   "
66389|NCT02697994|"~     ABSTRACT Introduction: In addition to pain caused by uterine contractions in labour, in 33%~     of women, continuous and severe back pain is observed. In management of this pain, sterile~     water injection is considered to be an effective method. Aim of this study is assessment of~     effectiveness and satisfaction of this method among Turkish women in which analgesic methods~     are not extensively used in labour and rates of cesarean section exponentially increases.~      Material and Methods: 168 termed, healthy women who admitted to Istanbul Gaziosmanpaşa-Taksim~     Training and Research Hospital with labour pain and had severe back pain were randomized into~     4x0.1 ml sterile water and 4xdry Injection groups. Injections were applied to Michaelis~     Rhomboid region in sacral region. Pain scores were assessed at 10th, 30th, 60th, 120th and~     180th minutes with Visual Analog Scale (VAS). Additionally, need for epidural analgesia,~     APGAR score, mode of delivery, time of delivery, maternal satisfaction and breastfeeding~     scores were assessed.~   "
66390|NCT02697981|"~     Background: Nutrition challenges follow bariatric surgery can intensify during pregnancy and~     may have a crucial effect on fetus. To the best of the investigators knowledge, the effect of~     nutritional counseling on improvement of maternal diet quality and eating habits among post-~     bariatric pregnant women has not been evaluated.~      Objective: study aims to expand the existing limited knowledge in respect to post bariatric~     pregnant women's eating habits and quality of food intake, and to investigate the impact of~     nutrition counseling on these factors.~      Design: This is a controlled clinical trial comparing post Laparoscopic sleeve gastrectomy~     (LSG) pregnant women who received nutritional counseling with age-matched control healthy~     pregnant women. Counseling will focus on improving quality of food consumption, eating habits~     and behavioral changes in order to improve the mother and the fetus' nutritional status~     Nutritional data and eating behavior will be obtained using 24 hours recall dietary records~     and the Family Eating and Activity Habit Questionnaire (FEAHQ).~   "
66391|NCT02697968|"~     Background: Ankylosing spondylitis imposes burdens on individuals and society that AS costs 3~     times higher than general population. Conventional approaches for AS have their limitation.~     Previous studies demonstrated acupuncture has significant therapeutic effects for AS in~     diminishing joint pain, enhancing functional disorders and modifying spinal deformity.~     Although acupuncture is effective in relieving pain in AS patients, the evidence is very~     limited due to methodological flaws.~      Design This study will be a single-arm pilot study in patients with AS. Eligible subjects~     will receive electroacupuncture treatment twice per week for at least 6 weeks (12 sessions in~     total). The length of treatment can be extended to a maximum of 10 weeks (20 sessions in~     total) if participants request a prolonged treatment. The acupuncturist, who is a registered~     Chinese medicine practitioner, of this trial will not participate in data collection and data~     entry.~      Objective: To explore the treatment effect of electroacupuncture for relieving pain in~     ankylosing spondylitis.~      Setting: Hong Kong~      Participants: 20 subjects with a diagnosis of ankylosing spondylitis~      Main Measures: Pain Severity Numerical Rating Scale (NRS), Adverse events~      Data analysis All data will be double-entered and checked for consistency before conducting~     the analysis. Binomial test will be used to analyze the percentage of responders to treatment~     compared with a reference value of 10%. Wilcoxon signed rank test will be used to compare the~     values of all continuous variables between baseline and post treatment. The population for~     safety analyses will include all subjects who receive at least one acupuncture treatment.~     Adverse events will be coded using the WHO Adverse Reaction Terminology Dictionary. Special~     attention will be given to those subjects who have discontinued treatment due to adverse~     events or who experience serious adverse events.~   "
66392|NCT02697955|"~     The study investigates the effect of a ultrasound-guided subsartorial saphenous block on~     postoperative pain following major ankle and hind foot surgery.~   "
66393|NCT02697942|"~     This will be a pilot, single center, randomized, controlled trial to slow cognitive decline~     in adults undergoing hemodialysis (HD). The investigators will test two interventions~     (cognitive training and exercise training) against the standard of care.~   "
66394|NCT02697929|"~     Cirrhotic patients undergoing liver transplantation are at very high risk of post operative~     complication such as post-operative residual curarization.~      Rocuronium is a neuromuscular blocking agent that nowadays can be safely and rapidly~     antagonized with sugammadex.~      No one study compared sugammadex versus neostigmine after rocuronium infusion during liver~     transplantation.~   "
66395|NCT02697916|"~     ADAPTABLE is a pragmatic clinical trial in which 20,000 patients who are at high risk for~     ischemic events will be randomly assigned in a 1:1 ratio to receive an aspirin dose of 81~     mg/day vs. 325 mg/day. Study participants will be enrolled over 24 months. Maximum follow-up~     will be 30 months. The purpose of the study is to identify the optimal dose of aspirin for~     secondary prevention in patients with Atherosclerotic cardiovascular disease (ASCVD). The~     primary endpoint is a composite of all-cause death, hospitalization for MI, or~     hospitalization for stroke. The primary safety endpoint is hospitalization for major bleeding~     with an associated blood product transfusion.~   "
66396|NCT02697903|"~     From the recent scientific literature in the field of biological response to physical~     exercise, a significant increase in muscle damage, soreness and inflammation were registered~     immediately and even 48 after resistance exercise. In the other hand, from the recent~     scientific literature in the field of nutrition it is well established that Pomegranate juice~     is a potent antioxidant that can help prevent or treat various disease risk factors. However,~     only few studies associated the effect of the pomegranate with the physical exercise. To the~     authors' knowledge, there are no studies investigated the acute and delayed effect of~     pomegranate supplementation in performance and muscle recovery after exercises involved~     muscle of whole body. Therefore, the aim of the present study was to investigate the effect~     of natural Pomegranate juice supplementation on the acute and delayed response of muscle~     soreness and biochemical parameters following weightlifting training session~   "
66397|NCT02697890|"~     The objective of this study is to evaluate clinically and radiographically the effect of~     Mucograft® seal when used for the ridge preservation procedure in combination with Freeze~     Dried Bone Allograft (FDBA) at the extraction site in terms of hard and soft tissue~     remodeling after 4 months healing period.~   "
66398|NCT02697877|"~     The aim of this study is to assess whether myocardial perfusion reserve, measured during~     routine clinically ordered regadenoson stress cardiac magnetic resonance (CMR) has prognostic~     value in predicting adverse cardiovascular events. Myocardial perfusion reserve will be~     measured with CMR by assessing blood flow through the coronary-sinus - the primary vein in~     the heart.~   "
66399|NCT02697864|"~     3 different formulations and doses of tafamidis will be compared. Subjects will be fasted for~     each test and every subject will test all 3 different formulations. After swallowing~     tafamidis, tafamidis blood concentrations will be measured periodically for 6 days. After 14~     days, subjects will take a different formulation of tafamidis and tafamidis blood~     concentrations will be measured periodically for 6 days. After another 14 days, the last~     formulation will be tested in the same way.~   "
66403|NCT02697812|"~     In North America, almost ½ million people undergo coronary artery bypass graft surgery~     annually and over 1/3rd develop chronic chest pain. The current study will randomize cardiac~     surgery patients to undergo slow sternal retraction for heart exposure (over 15 min.) versus~     standard-of-care (sternal opening over 30 seconds) and examine the incidence and severity of~     chronic post-sternotomy pain (CPSP) and quality-of life 3, 6 and 12 months post-operatively.~     The severity of acute post-operative pain will also be measured. Increased retraction time~     reduces forces required, which should translate to reduced nerve/tissue damage. If effective,~     this simple change in practice could be readily implemented with a major impact for patients~     and the health care system overall.~   "
66404|NCT02697799|"~     In a multicenter, randomized clinical trial of attitudes towards research participation, we~     will evaluate the ethics, effectiveness, and cost- effectiveness of three recruitment~     strategies for research participation in a mobility trial among hospitalized patients and a~     smoking cessation trial among patients with depression.~   "
66405|NCT02697786|"~     Postoperative brain damage and neuropsychological disorders have been observed in 30 - 80 %~     of patients after heart surgery with the use of cardiopulmonary bypass (CPB).They can persist~     up to a year after cardiac surgery and are associated with increased hospital mortality and~     prolonged intrahospital stay.~      Hypoperfusion,hyperthermia,atrial fibrillation,genetic predisposition and systemic~     inflammatory response associated with CPB have been identified as pathophysiological~     mechanisms.However, some authors consider cerebral embolisation to be the prevalent mechanism~     of intraoperative brain injury after cardiac surgery,as gaseous or solid cerebral emboli can~     cause ischemia, inflammation and edema,consequently causing cerebral infarctions usually~     resulting with stroke,coma,encephalopathy, delirium and cognitive decline. Additionally,they~     may impair cerebrovascular reactivity (CVR).~      Aortic valve replacement (AVR) preformed by full sternotomy is the standard approach in the~     treatment of aortic valve disease. Minimally invasive (MIS) aortic valve replacement has been~     shown to reduce postoperative mortality, morbidity, and pain while providing faster recovery,~     a shorter hospital stay, and better cosmetic results. However, due to technically more~     demanding procedure, MIS may lead to prolonged CPB time and incomplete de-airing of the heart~     with an increased risk for cerebral gas embolization. Therefore, the choice of MIS might bear~     an augmented risk for brain injury.~      Transcranial Doppler (TCD) enables real time detection of intraoperative emboli in the~     cerebral arteries seen as microembolic signals (MES), and is an essential neuromonitoring~     tool. Several studies demonstrated correlation between the number of MES and the occurrence~     as well as severity of postoperative neurological complications. However, the factors~     contributing to brain injury have not been elucidated in those studies. The investigators~     speculate that impairment of CVR is an important mechanism that persists and prolongs the~     duration of brain injury into postoperative period.~      The aim of the study is to compare two surgical approaches used for AVR, with focus on the~     number of MES and their impact on levels of protein S100B (marker of brain tissue~     damage),postoperative CVR and cognitive function With the results,the investigators aim to~     help surgeons in selecting the appropriate technique for AVR in individual participants,as~     well as to clarify the effect of aortic valve surgery on the brain.~   "
66406|NCT02697773|"~     The primary purpose of this study is to evaluate the efficacy of a titration arm of tanezumab~     in which treatment is started at a lower dose (2.5 mg) and increased to a higher dose (5 mg)~     at Week 8, compared to giving 2 doses of tanezumab 2.5 mg or 2 doses of placebo. The study~     also evaluates the safety of the treatment regimens.~   "
66407|NCT02697760|"~     To develop and validate the noninvasive measurement of MBF and MFR by using dynamic imaging~     with a CZT camera, and evaluate the diagnostic and prognostic implications in various heart~     disease.~   "
66408|NCT02697747|"~     The investigators hypothesize that teaching ultrasound sonoanatomy to identify the L3-L4~     interspace will improve resident's long term skill to correctly identify the interspace as~     compared to palpation alone.~   "
66409|NCT02697734|"~     Purpose of study is to aim to confirm efficacy and safety of osilodrostat for the treatment~     of patients with Cushing's disease who are candidates for medical therapy~   "
66410|NCT02697721|"~     The purpose of this study is to examine if a psycho-educational intervention for caregivers~     of patients with dementia will decrease caregiver burden, increase caregiver physical~     activity, and decrease the reporting of behavioral and psychological symptoms of the person~     with dementia.~   "
66411|NCT02697708|"~     This study is designed to compare the effect of different dietary potassium sources on uptake~     and retention of potassium, as well as to determine the effect of potassium intake on blood~     pressure and acid-base balance. The study will compare three different sources of potassium~     given as a supplement, potatoes or French fries.~   "
66412|NCT02697695|"~     To evaluate the impact of obesity surgery on chronic inflammation.~   "
66413|NCT02697682|"~     To investigate the feasibility and short term safety issues of treatment of knee~     osteoarthritis with intra-articular injection with the stromal vascular fraction of abdominal~     adipose tissue (SVF) harvested and prepared using the Lipogems System.~      Hereby we wish to pave the road for a high quality randomized controlled trial investigating~     effectiveness of treatment of knee osteoarthritis with SVF looking at patient reported~     outcome, function, homeostasis of the joint and cartilage regeneration.~   "
66414|NCT02697669|"~     Heart failure is a clinical syndrome of exercise intolerance and/or congestion. The potential~     roles of myocardial perfusion and metabolic abnormalities in subjects with cardiovascular~     risks, metabolic disease and heart failure assessed by nuclear dynamic imaging warrant~     further investigations. The study investigators propose that microvascular dysfunction and~     abnormal metabolic substrate shift precedes and triggers the onset of diastolic dysfunctions.~     The aims are (1) to develop and validate the noninvasive measurement of absolute myocardial~     blood flow (MBF) and myocardial flow reserve (MFR) by using dynamic imaging with a CZT~     camera, (2) to assess myocardial glucose metabolism by using 18F-FDG dynamic PET, and MBF,~     MFR and LV systolic and diastolic function by dynamic SPECT comprehensively in subjects at~     cardiovascular risks and metabolic disease, HFrEF and HFpEF, (3) to correlate with peripheral~     serum markers and blood mononuclear cells subsets with myocardial perfusion and metabolic~     abnormalities, and (4) to test the hypothesis of these imaging and blood markers in diagnosis~     and prognostic implications. The study investigators also assess myocardial metabolic~     utilization in healthy and mice model of different metabolic disorders (obesity, diabetes~     mellitus and hypertension) by using 18F-FDG dynamic micro PET/CT, as an in-vivo measures~     which could be used to better understanding the disease mechanism and evaluating therapeutic~     strategies.~   "
66423|NCT02697539|"~     This 12-week prospective, randomized, double-blind, two-center trial evaluated the impact of~     a microcrystalline zinc-hydroxyapatite (mHA) dentifrice on plaque formation rate (PFR) in~     periodontitis patients. The investigators hypothesized that mHA precipitates cause delayed~     plaque development when compared to a fluoridated control (AmF/SnF2), and therefore would~     improve periodontal health.~   "
66424|NCT02697526|"~     The aim of the study is to determine differences on radial artery occlusion from two~     compressive methods used after transradial catheterization and its functional impact on hand~     mobility.~   "
66415|NCT02697656|"~     Individual Placement and support (IPS) is an evidence-based approach originally developed to~     help people with severe mental disorders to obtain and maintain employment. The effectiveness~     of IPS for patients with severe mental illness is well documented, but has never previously~     been tested for patients with chronic pain. In fact, employment support is rarely provided in~     pain clinics, despite an increasing focus on integrating work and health in all patient~     treatment (OECD, 2013). The aim of this study is to investigate the effectiveness of IPS as~     an integrated part of the interdisciplinary treatment for patients with chronic pain in a~     hospital outpatient clinic.~   "
66416|NCT02697643|"~     For behavioral health clinicians who are interested in getting tailored treatment and level~     of care recommendations, BH-CDS is a desktop/tablet web-based application that provides~     clinicians with data and a rationale for better decision-making to improve patient care.~      Few Clinical Decision Support (CDS) systems are available for Behavioral Health, and unlike~     existing CDS this product will compile relevant patient data and organize these data into~     general treatment recommendations linked to the patient's presenting circumstances, symptoms~     and substance use issues.~      The BH-CDS solution shall factor patient characteristics into a Latent Class Analysis (LCA)~     that will group patients according to their responses with other patients with similar~     responses (i.e., a subgroup or class). Once patients have been assigned to a class, the~     solution shall present recommendations to counselors that use the software.~   "
66417|NCT02697630|"~     The purpose of this study is to see if the combination of entinostat and pembrolizumab can be~     an effective treatment for patients with melanoma of the eye (uveal melanoma) that has spread~     to other sites of the body (metastatic disease). Pembrolizumab is an antibody that helps the~     immune system to attack cancer cells. Although pembrolizumab has proven clinical efficacy in~     treating patients with metastatic cutaneous melanoma, an effect on metastatic uveal melanoma~     has not been established. Entinostat is a histone deacetylase (HDAC) inhibitor that has~     effects on both cancer cells and immune regulatory cells, thus potentially enhancing the~     effects of immunotherapy.~   "
66418|NCT02697617|"~     Funding Source - FDA OOPD~      Pioglitazone is currently used in clinical practice to treat diabetes and this study will~     examine the potential use of a low dose of the same drug for the treatment of polycystic~     kidney disease. The purpose of this study is to determine whether the diabetes drug~     pioglitazone (Actos) is a safe and effective treatment of autosomal dominant polycystic~     kidney disease when treated in its early stages. Pioglitazone is approved by the FDA for the~     treatment of diabetes. Pre-clinical models of polycystic kidney disease have shown that low~     dose treatment with pioglitazone decreases the growth of the cysts. The studies also suggest~     that effective pioglitazone dosing for polycystic kidney disease may be lower than that used~     to treat diabetes. The purpose of this study is to see if pioglitazone might slow cyst~     disease in humans.~   "
66419|NCT02697591|"~     This is an open-label, non-randomized Phase 1/2 safety study of INCAGN01876 in subjects with~     advanced or metastatic solid tumors that will be conducted in 2 parts. Part 1 will determine~     the pharmacologically active dose and/or maximum tolerated dose of INCAGN01876. Part 2 will~     further evaluate the recommended dose determined in Part 1 in subjects with select tumor~     types.~   "
66420|NCT02697578|"~     In hemodialysis patients, deviations of serum concentration of calcium, phosphate or~     parathyroid hormone from the values recommended by KDIGO are associated to a negative~     outcome. The regulation of calcium, phosphate and parathyroid hormone is complex and each~     parameter is not independently regulated. In hemodialysis patient's simultaneous modification~     in these three parameters are the result of abnormal mineral metabolism and the treatment~     used to correct these abnormalities that usually produce changes in more than one parameter.~     The specific objective of this work is an accurate and exhaustive analysis and description of~     the complex relationships between clinically relevant parameters in chronic kidney disease~     metabolism bone disease. In order to achieve these objectives we have used a machine learning~     approach Random Forest able to extract useful knowledge from a large database. The analysis~     of the complex interactions between the different parameters needs an advance mathematical~     approach such as Random Forest . The second aim of this study is to determine whether~     calcium, phosphate and parathyroid hormone, Fibroblast growth factor 23 and calcitriol are~     long-term associated with demographic features, mortality, co-morbidity and the therapy~     prescribed. Compare the predictions obtained with conventional statistical analysis versus~     the new model analysis based on artificial intelligence. Our preliminary results suggest that~     there are interactions between some parameters that are strong enough to question whether the~     evaluation of a given therapy can be based in the measurement of one single parameter.~     Subsequently, we will analyze in a prospective study on incident patients, whether the use of~     this new model may predict the cardiovascular risk and reduce the therapy cost.~   "
66421|NCT02697565|"~     One in four U.S. children under the age of 5 years old are either overweight or obese with~     ethnic-minority children being disproportionately affected. Low-income preschool children,~     many from ethnic minority backgrounds, receive childcare in federal/state subsidized centers~     where daily meals are provided. Nationally, the Quality Rating and Improvement Systems (QRIS)~     organization is responsible for rating the quality of childcare centers. However, nutrition~     and physical activity policy standards have not been incorporated into QRIS childcare center~     policies. Therefore, the goal of this project is to address the 2014 AFRI program area~     priority of Childhood Obesity Prevention by building on the phase I Healthy Caregivers,~     Healthy Children (HC2) NRI/AFRI funded project (2010-2013), in partnership with the Miami~     Dade County Cooperative Extension team, to evaluate the program via randomized-controlled~     trial outcomes, and deliver an evidence-based effective childcare center-based~     program/toolkit. This project (phase II) will expand HC2 Phase I findings by transferring the~     evidence-based HC2 program/toolkit to QRIS childcare centers via a train-the-trainers (TTT)~     model. The following specific aims are proposed; (1) to evaluate the TTT model of delivery~     for the evidence-based HC2 toolkit's effectiveness versus an attention control on parent and~     teacher adoption of healthy lifestyle role modeling behaviors, and policy integration; (2) to~     evaluate the impact of a TTT delivery model versus an attention control on child body~     composition and short- and long-term behavioral health outcomes, and (3) to disseminate the~     HC2 early childhood obesity prevention toolkit TTT model within the QRIS early childhood~     network at the Miami Dade County-level.~   "
66425|NCT02697513|"~     Infection and sepsis are among the leading causes of death worldwide, particularly in middle-~     and low-income countries.The Surviving Sepsis Campaign has launched an initiative to improve~     sepsis care in resource-limited settings by employing the 'Scan-Teach-Treat' Approach. In~     this prospective before-after study, three interventions will be performed: First four months~     period: collection of baseline data on the clinical management of patients with acute~     infection. Second four months period: During the first days, a 1.5-day focused training~     program will be performed (participants: health care workers of primary care facilities~     within the catchment area of the Gitwe hospital and health care workers of the Gitwe~     hospital). Then, a simple management protocol to care for patients with an acute infection~     will be implemented into clinical practice. During the third four months period, a 'Sepsis~     First Aid' kit containing essential resources to treat patients with an acute infection~     (antimicrobials, fluids, data documentation sheet) will be distributed to primary care~     facilities and the emergency department of the Gitwe hospital. During the 8 months following~     the focused training program (periods 2 and 3), data collection will continue. It is~     hypothesized that implementation of a simple clinical management protocol and exposure of~     health care workers in the Gitwe Hospital area to a focused training program on the~     management of acute infections will increase the rate of evidence-based interventions~     performed in patients with an acute infection during the first six hours after hospital~     admission (administration of oxygen and fluids whenever indicated, timely administration of~     antimicrobial drugs, source control measures).~   "
66426|NCT02697500|"~     This study evaluates how blood serum handling conditions can affect the concentrations of~     ~1,000 serum metabolites and attempts to quantify the degree of attenuation and/or potential~     bias in epidemiologic associations that may result from less than optimal sample handling~     conditions.~   "
66427|NCT02697487|"~     This is a longitudinal observational study (via electronic records and biospecimens) designed~     to utilize health IT advances to collect information from patients undergoing routine care.~     This information will be stored in a database. Patients undergoing routine care from their~     providers will be invited to participate in the UTSW Depression Cohort. After obtaining~     informed consent, the CDRCC team will collect information from available sources and store it~     in a secure UT Southwestern network database protected by a security firewall. A schematic~     representation of this information processing is shown in the figure contained in section 3~     of the protocol. As part of the UTSW Depression Cohort, patients will allow banking of their~     specimens. Specimens which are banked may include blood or blood products, urine, tissue~     samples, saliva, stool samples or clinical waste products. The study will only enroll~     participants comfortable with providing specimens. As the goal of the UTSW Depression Cohort~     is to create a national database, CDRCC will engage with patients, providers, and researchers~     at local, regional, and national levels. A large number of medical providers are already~     screening patients for depression. Structured instruments like PHQ-2 or PHQ-9 are often used.~     Hence, the CDRCC will seek collaborations with local, regional and national partners so that~     information contained in their health IT initiatives can be included in the this database.~     Due to the clinical nature of information collected, the investigators anticipate marked~     heterogeneity in the variables and amount of data collected. Database architects will utilize~     big data (large volumes of information from diverse sources with variable degrees of quality~     and complexity) tools to structure the registry so that additional variables can be added, as~     needed. The CDRCC team will maintain a detailed codebook of variables collected in the~     database. All statistical analyses will be conducted only on de-identified data. Researchers~     may obtain access to this de-identified data by following procedures established by the~     CDRCC, which include obtaining IRB approval.~   "
66428|NCT02697474|"~     The aim of the study is to assess the persistence of anti-Hep B antibody at 9 to 10 years of~     age after the last priming dose in subjects who completed study A3L12 (NCT00401531), and also~     evaluate the immune response against hepatitis B one month after vaccination (challenge~     vaccination) with a stand alone monovalent hepatitis B vaccine.~      Primary objectives:~        -  To describe the persistence of anti-hepatitis B antibody at 9 to 10 years of age after~          last priming dose in subjects having received hepatitis B vaccine at birth and a~          hexavalent vaccine at 2, 4 and 6 months of age according to the vaccine received during~          A3L12 study (Hexaxim® [Group 1] or Infanrix® hexa [Group 2])~        -  To evaluate the immune response against hepatitis B one month after vaccination with a~          stand alone monovalent hepatitis B vaccine (challenge vaccination).~      Secondary objectives:~        -  To describe serious adverse events (SAEs) reported throughout the trial after~          administration of hepatitis B vaccine.~   "
66429|NCT02697461|"~     Lateral ankle sprains (LAS) and chronic ankle instability (CAI) are common musculoskeletal~     injuries that are a result of inversion injury during sport. The midfoot is frequently~     involved during inversion injury, is often overlooked during clinical examination, and maybe~     contributory to the development of CAI. The purpose of this study is to investigate~     multisegmented foot motion using a motion capture system, clinical joint physiological and~     accessory motion, and morphologic foot measurements in recreationally active men and women~     with and without a history of lateral ankle sprains and chronic ankle instability.~     Additionally, the effects of a joint mobilization intervention in patients with diminished~     multisegmented foot motion and intrinsic foot strengthening in healthy individuals will be~     investigated.~   "
66430|NCT02697448|"~     Comparison of propofol and sevoflurane as a primary anesthetic for cardiac ablation of atrial~     fibrillation~   "
66431|NCT02697435|"~     Back pain is a huge problem for millions of Americans, including nearly 11 million Veterans.~     Our older Veterans suffer the most. Citizens spend billions of dollars, yet consistently get~     poor results. Primary Care Providers are often tasked with diagnosing and treating Chronic~     Low Back Pain, even though they are often undereducated in the field. These PCPs often use~     advanced imaging, usually MRIs to guide care. These images often show degenerative disc~     disease and other common pathologies in older adults, even those who are pain free, which can~     lead to misdiagnosis and treatment. The investigators believe that Chronic Low Back Pain is a~     syndrome, a final common pathway for the expression of multiple contributors that often lie~     outside the spine itself. For example, hip osteoarthritis, knee pain, and even anxiety could~     all lessen back pain if addressed and treated probably.~      Investigators will measure participants' low back pain-associated disability with the~     well-validated RMDQ. Data will be collected at baseline and monthly via telephone. The~     investigators hypothesize that veterans who receive PCCET will experience significantly~     greater reduction in low back pain-associated disability than those who receive IAUC at six~     months.~      Investigators will also measure participants' low back pain with the 0-10 Numeric Rating~     Scale for Pain. Data will be collected at baseline and monthly via telephone. The~     investigators hypothesize that veterans who receive PCCET will experience significantly~     greater reduction in low back pain than those who receive IAUC at six months.~      The goal of this study is to compare patients treated with usual care, which usually starts~     with imaging, versus patients who are treated by trained geriatricians who know how to~     recognize and address 11 key conditions that commonly drive pain and disability in older~     adults. The investigators believe that older patients who receive care tailored to their~     needs by educated PCPs will ultimately have less back pain and, more importantly, better~     quality of life.~   "
66432|NCT02697422|"~     The purpose of this study is to test if having a Veteran peer health coach will improve blood~     pressure control among Veterans with high blood pressure and at least one other~     Cardiovascular disease (CVD) risk factor. The intervention will deliver brief health~     messages, discuss goal setting, and action planning around health behavior changes shown to~     decrease CVD risk, including healthy diet, regular to moderate-intensity physical activity,~     and smoking cessation. Facilitators, barriers, and costs of the intervention will be~     determined.~   "
66436|NCT02697370|"~     Patients with severe Haemophilia A need prophylactic factor VIII to reduce their risk of~     joint and soft tissue bleeds and to prevent or reduce joint damage. It is common practice to~     give enough factor VIII to maintain the trough level above 1% of normal and this has been~     supported in retrospective studies.~      The amount of factor VIII required to maintain this trough level varies markedly between~     patients because their factor VIII half lives are different. This study will assess the role~     of regular pharmacokinetic (PK)monitoring and dose adjusted factor VIII to establish whether~     this is a more cost effective way of giving treatment and whether it is feasible in routine~     clinical practice. Patients will be treated for 6 months with their standard factor VIII~     regimen and followed up to establish their bleed frequency. They will then receive~     pharmacokinetic adjusted factor VIII to maintain a trough above 1.5% for a year and their~     bleed rate compared to standard treatment. If they have increased break through bleeds their~     factor VIII will be increased to maintain a trough of 3%.~   "
66437|NCT02697357|"~     The aim of this study is to adapt and pilot test a type of therapy called Emotion Regulation~     Therapy (ERT-C) for informal caregivers of patients with cancer. Informal caregivers include~     partners, family members, children, parents, and friends providing informal care to a~     patient. Providing care to someone with cancer can be difficult. The purpose of this~     intervention is to improve coping and physical well-being among caregivers, which in turn~     will allow them to provide better care for their loved ones. Investigators would also like to~     learn about biological factors like stress that may affect one's emotional and physical~     well-being. This study will allow to better understand caregivers needs, and further develop~     a program to provide services to caregivers within MSKCC community and nationwide.~   "
66438|NCT02697344|"~     This phase I/II trial studies the side effects and best dose of R-(-)-gossypol acetic acid~     when given together with lenalidomide and dexamethasone and to see how well it works in~     treating patients with multiple myeloma, also known as plasma cell myeloma, that has come~     back after a period of improvement or has gotten worse after treatment. R-(-)-gossypol acetic~     acid may stop the growth of cancer cells by recognizing certain proteins and stimulating~     programmed cell death. Lenalidomide may stimulate or suppress the immune system in different~     ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone,~     work in different ways to stop the growth of cancer cells, either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading. Giving R-(-)-gossypol acetic~     acid with lenalidomide and dexamethasone may work better in treating patients with multiple~     myeloma.~   "
66439|NCT02697331|"~     Aim of the work The aim of this study is to assess the efficacy of the use of vaginal~     progesterone as a method of prevention of preterm labour in twin gestations with short cervix~     .~      Study Design:~      The study is designed as randomized ,placebo-controlled, clinical trial . All women with~     dichorionic diamniotic twin pregnancy will be followed up in the antenatal care at the out~     patient clinic. Randomization of cases will be done by computer method . 130 women with~     dichorionic diamniotic twin pregnancy and cervical length 10mm to 25mm discovered on~     transvaginal sonogram between 20w to 24w gestational age will be enrolled in the study and~     will be distributed in two groups:group P (cases ) and group N (controls) . The randomization~     allocation will be 1 : 1 (vaginal progesterone capsule : placebo).~   "
66440|NCT02697318|"~     The purpose of this project is to demonstrate that there is a new easier method to instill~     eye drops in ones own eye that is as effective as applying a drop directly to their open eye.~     The benefits of this new method include better medication compliance and reduced patient~     anxiety from instilling their eye drops. This secondary benefit should remove the~     approach-avoidance response that prompts some patients to delay or give-up on instilling~     their drops just to avoid the angst and frustration produced by the challenge.~      The new method involves the patient instilling the eye drop onto their closed eyelid and then~     blinking the eye drop into their eye. We aim to show that this method has a similar~     therapeutic effect as the routine administration of an eye drop to an open eye.~   "
66441|NCT02697305|"~     Branched chain amino acids (BCAA) are known to exert insulinogenic effect. Whether this~     effect is mediated by incretins (GLP-1, GIP) is not known. The aim of the study was to show~     incretin effect of BCAA, i.e. whether the oral administration of BCAA elicits higher insulin~     and incretin response when compared with IV route of the same dose of BCAA. Eighteen healthy,~     male subjects participated in three tests: IV application of BCAA solution (30.7±1.1 g of~     BCAA, IV BCAA) second was oral ingestion of BCAA capsules in the same dose (ORAL BCAA) and~     third experiment was oral placebo (PLACEBO). Glucose, insulin, GLP-1, GIP, valine, leucine~     and isoleucine levels were measured at time interval for up to 4 h.~   "
66442|NCT02697292|"~     The purpose of this study is to determine whether intravenous immunoglobulin (IVIG) treatment~     reduces significantly the number of epileptic seizures in cases of autoimmune epileptic~     seizures.~   "
66443|NCT02697279|"~     In the Emergency Department (ED), patients frequently seek medical treatment for cutaneous~     abscesses. Traditional incision and drainage (I&D), with or without packing of cutaneous~     abscesses has long been the accepted standard of care. This procedure is often very painful~     for the patient. Additionally, compliance with wound care and follow-up can present barriers~     to proper care and healing. Research has suggested that incision and loop drainage of an~     abscess may be another effective treatment for simple cutaneous abscess. Thus far, research~     into this procedure has been limited to the pediatric population with small sample sizes. In~     these previous studies, this technique was found to be an effective and less painful~     treatment for abscesses. Research has not been done in the adult population using this~     procedure. If this procedure is found to be as effective and less painful in the adult~     population, then it should be considered as a potential preferred I&D method for cutaneous~     abscess in the ED.~   "
66444|NCT02697266|"~     The purpose of the current proposal will be to examine the clinical performance of both~     physicians in training as well as experienced faculty in pre and post call situations. Groups~     will be matched for gender, age, experience and employment duration during regular hours~     versus immediate post call hour.~   "
66510|NCT02696408|"~     The LLLT has an anti-inflammatory, analgesic effect and accelerates the healing of ulcerated~     lesions. There are little data in the literature showing its efficacy in prevention of~     mucositis in cohorts of patients with hematopoietic stem cells transplantation.~      The main objective of this study is to assess the efficacy of a prophylactic low level laser~     therapy performed by nurses on the severity of oral mucositis during HSCT.~   "
66445|NCT02697253|"~     The goal of this project is to identify predictors of success in the treatment of obesity~     after roux-en-y bariatric surgery. The specific aims of this proposal are to:~        1. employ behavioral tests of mechanisms that control food intake in normal weight~          individuals, to determine which intake control mechanisms lead to changes after~          Roux-en-y gastric bypass (RYGBP); and~        2. measure behavioral and psycho-social predictors of weight loss and food intake~          reduction, so as to determine which are most predictive of successful weight loss and~          food intake reduction.~      The mechanism investigators propose to account for success is reduction in food intake~     brought about by the pattern of hormone release, particularly glucagon-like peptide-1~     (GLP-1), and gastric distention, both known to underlie satiation, coupled with~     post-ingestive changes in reinforcing value of food and motivation to consume. Tests of the~     hypothesis will be done by measuring responses to tasting, working for, and consuming, foods~     on sensory, motivational, cognitive, and physiological variables, including amount consumed~     and rate of eating under standardized conditions, before surgery and at a two year follow up~     visit. In addition the inhibitor exendin-9-39 (EX9) will be infused before a meal to~     determine whether blockade of GLP-1 Receptor after surgery partially reverses intake~     reduction. Investigators predict that successful patients will show changes that favor~     reduction in food intake, rate of eating, motivation to consume, reward value of foods, and a~     hormone profile that has been shown to generate satiation and maintain reduction in intake~     (e.g. increased Cholecystokinin (CCK), GLP-1, reduced ghrelin). To the extent that~     psycho-social and cognitive factors may override physiological brakes to eating behavior, the~     subjects may fail to achieve success, and consequently the failure may be predicted from~     over-impulsiveness or inability to suppress working for rewarding food stimuli. To test these~     hypotheses, a total of 50 patients will be enrolled prior to RYGBP and restudied 2 years~     after the surgery. Based on known high attrition in this population and our past 10 year~     experience with bariatric research, it is estimated that 100 patients will need to be~     enrolled over 2 years to obtain 50 who complete testing at 2 years. EX9 studies will be done~     in a subset of 30 completers, only after roux-en-y gastric bypass (RYGBP), 15 failure (<15%~     weight loss) 15 success ( >30% weight loss).~   "
66446|NCT02697240|"~     Sickle cell disease is a genetic red blood cell disorder characterized by vaso-occlusion from~     sickling of red blood cells, that can lead to pain or organ complications such as acute chest~     syndrome. Sickle cell disease is associated with low amounts of nitric oxide, a compound~     important for dilating the blood vessel wall. Citrulline is a substance that is known to~     increase nitric oxide. The goal of this Phase I study are to find the highest safe dose of~     continuous IV citrulline that can be given to individuals with sickle cell disease~     experiencing a sickle cell pain crisis or acute chest syndrome without causing severe side~     effects.~   "
66447|NCT02697227|"~     The goal of this research study is learn if Behavioral Activation Treatment (BATS) or Health~     Education/Smoking Cessation counseling (HE), combined with the nicotine patch, can help~     people with different types of emotion and attention levels quit smoking.~   "
66448|NCT02697214|"~     Over the last two decades, there has been a proliferation of commercially available heart~     rate monitors. Recognizing that elite athletes often use heart rate to monitor training and~     assess aerobic fitness, fitness companies have offered a variety of heart rate monitoring~     systems to the general public. Recently, there has been a move from monitors that rely on~     chest straps to measure electrical activity toward more convenient, wrist-worn monitors that~     employ optical sensing technology similar to that used for pulse oximetry. While the accuracy~     of chest strap monitors has been assessed in a variety of studies, there is no data~     concerning the accuracy of wrist-worn heart rate monitors. Assessment of the monitors'~     accuracy is important both for the subjects who rely upon these monitors to guide their~     athletic activity and for the physicians to whom these individuals report their heart rate~     readings.~   "
66449|NCT02697201|"~     Insulin promotes the clearance of sugars from the blood into skeletal muscle and fat cells~     for use as energy; it also promotes storage of excess nutrients as fat. Type 2 diabetes~     occurs when the cells of the body become resistant to the effects of insulin, and this causes~     high blood sugar and contributes to a build-up of fat in muscle, pancreas, liver, and the~     heart. Understanding how insulin resistance occurs will pave the way for new therapies aimed~     at preventing and treating type 2 diabetes.~      Mitochondria are cellular structures that are responsible for turning nutrients from food,~     into the energy that our cells run on. As a result, mitochondria are known as the powerhouse~     of the cell. Mitochondria are dynamic organelles that can move within a cell to the areas~     where they are needed, and can fuse together to form large, string-like, tubular networks or~     divide into small spherical structures. The name of this process is mitochondrial dynamics~     and the process keeps the cells healthy. However, when more food is consumed compared to the~     amount of energy burned, mitochondria may become overloaded and dysfunctional resulting in a~     leak of partially metabolized nutrients that can interfere with the ability of insulin to~     communicate within the cell. This may be a way for the cells to prevent further uptake of~     nutrients until the current supply has been exhausted. However, long term overload of the~     mitochondria may cause blood sugar levels to rise and lead to the development of type 2~     diabetes.~      This study will provide information about the relationship between mitochondrial dynamics,~     insulin resistance and type 2 diabetes.~   "
66450|NCT02697188|"~     Determine the serum pharmacokinetic profile for two oral formulations of T-esters (one TE and~     one TU) administered once -(QD) and twice-daily (BID) to hypogonadal men.~   "
66451|NCT02697175|"~     To assess the effect of live video-colposcopy on women´s anxiety.~   "
66452|NCT02697162|"~     Study design is a prospective, randomised, double-blind, and interventional. Primary aim of~     the study is to investigate efficacy of antiseptic-coated intermittent hydrophilic urinary~     catheters in prevention and reduction of catheter-associated urinary tract infections in~     children with neurogenic bladder. Secondary aim is to assess feasibility of antiseptic-coated~     intermittent hydrophilic urinary catheters in neurogenic bladder management. Octenidine~     chloride will be used as antiseptic.~   "
66453|NCT02697149|"~     Radiation exposure may put endoscopists at risk when performing endoscopic retrograde~     cholangiopancreatography. Although non-radiation endoscopic retrograde~     cholangiopancreatography was reported in pregnant women in previous reports, it remains~     unclear whether endoscopic retrograde cholangiopancreatography is also effective and safe~     when endoscopists were not expose to radiation. This study was to evaluate the effectiveness~     and safety of nonradiation-to-endoscopist endoscopic retrograde cholangiopancreatography in~     patients with complexity level I/II.~   "
66454|NCT02697136|"~     The purpose of this study is to assess the impact of 29 intravenous infusions of CER-001 vs.~     placebo, given at weekly (9 infusions) and biweekly (20 infusions) intervals on carotid~     vessel wall area as measured by 3TMRI, when administered to patients with familial primary~     hypoalphalipoproteinemia with proven CVD and appropriate background lipid-lowering therapy.~   "
66455|NCT02697123|"~     The purpose of the study is to prospectively assess the prevalence of venous thrombosis in~     women hospitalized for Cesarean Section, vaginal delivery or extended antepartum~     hospitalization by using Compression ultrasound of the entire proximal venous system of the~     lower limb veins.~   "
66456|NCT02697110|"~     Social interaction (in the form of serve and return exchanges) between child and parent are~     crucial for psychosocial, physical and cognitive development. Parents in sub-Saharan~     countries are ill-equipped to maximize the benefits from this interaction. The investigators~     approach builds on the traditional outlook that it takes a village to raise a child i.e.,~     not only the parents but other extended family members play a role as caregivers to young~     children. The investigators intention is to use the existing post-natal/child welfare clinics~     to deliver an intervention, which uses culturally acceptable videos and active skills~     building, to deliver health messages and practical skills to women, with the intention that~     they will subsequently engage and teach their partners and other caregivers about early brain~     stimulation and child development.~   "
66457|NCT02697097|"~     Hip Muscle Strength in femoro-acetabular impingement participants versus normal controls.~      To investigate the hip muscle strength in a normal control group and compare this to patients~     who have a diagnosis of femoro-acetabular impingement (diagnosed clinically and with~     confirmed radiological features).~   "
66458|NCT02697084|"~     Anal canal cancer is a relatively rare disease, representing 1.2% of digestive cancers and 6%~     of anorectal cancers. Incidence is less than 1/100 000 of the general population. However,~     the incidence has increased considerably over the past three decades. The main risk factors~     are HPV infections and smoking. Initial treatment comprises radiochemotherapy or radiotherapy~     alone, according to the patient's tumor stage and tolerance of chemotherapy. The choice of~     the most appropriate treatment strategy will condition the patient's prognosis. Consequently,~     early assessment of the initial extension of the tumor, its therapeutic response and relapses~     constitute determining factors in the management of the disease Despite the good results~     obtained, persistent disease is observed in 30% of cases and abdominal-pelvic salvage~     amputation can then prove effective in cases of local or loco-regional relapse. The great~     majority of relapses occur within 2 years after treatment. Reported prognostic survival~     factors are the T stage, size inferior or superior to 4 cm and inguinal or pelvic lymph node~     involvement.~      The rules for follow-up are not substantiated by high levels of proof. Follow-up focuses~     principally on the clinical examination although the type and frequency of the paraclinical~     examinations are not backed by any consensus.~   "
66459|NCT02697071|"~     This research study will be a prospective, randomized, double-blind, placebo-controlled~     trial. Because ketamine has yet to be directly studied as treatment for acute migraine~     headache in the emergency department, the research team is initially interested if ketamine~     can reduce pain scores in headache patients and reduce the incidence of recurrence while~     exhibiting an adequate safety profile. By using a placebo-controlled study design, the~     research team can adequately investigate the effectiveness of the medication in a subgroup~     previously not well studied.~   "
66460|NCT02697058|"~     Study Part 1: To assess the safety and tolerability, and to characterize the pharmacokinetics~     (PK) of BAX2398 in combination with 5-FU/calcium levofolinate in Japanese patients.~      Study Part 2: To compare the efficacy of BAX2398 in combination with 5-FU/calcium~     levofolinate versus 5-FU/calcium levofolinate as assessed by Progression Free Survival (PFS)~     using Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1).~   "
66461|NCT02697045|"~     Nautralsitic, Open-label, Single Arm, Uncontrolled Study Evaluating the Effects of Long~     Acting Injectable (LAI) on Phychosocial Functioning Congitive Functioning and Patient~     Reported Acceptability of Treatment 'Reported Acceptability of Treatment' Regarding Quality~     of Life Subjective Well-being Under Neuroleptic Medication in Schizophrenia Patients~   "
66462|NCT02697032|"~     Rationale: The purpose is to evaluate whether non-invasive in vivo imaging of androgen~     receptor (AR) presence in metastatic breast cancer patients by means of~     18F-fluoro-dihydrotestosterone positron emission tomography (FDHT-PET) can be used to predict~     (early) treatment response to, and optimal dosing of, the anti androgen bicalutamide. The~     ultimate goal is to contribute to optimal selection of breast cancer patients for anti~     androgen treatment. Objective: Feasibility to detect a diffrence in uptake on 18F-FDHT scan~     after 6 weeks of treatment with bicalutamide in metastatic breast cancer patients. Secondary~     Objectives: to describe whether changes in 18F-FDHT tracer uptake after six weeks associates~     with response to bicalutamide, to describe whether changes in AR availability are different~     for breast cancer subgroups during treatment with bicalutamide and to describe whether~     18F-FDHT tracer uptake is influenced by the amount of AR tumor expression. Study design: This~     is a single arm, one stage feasibility study, which will be executed in the University~     Medical Center Groningen, The Netherlands. The primary endpoint of the study is to evaluate~     the difference in 18F-FDHT uptake in tumor lesions after 6 weeks of bicalutamide treatment in~     patients with AR-positive metastatic breast cancer. Patients will be treated with~     bicalutamide until progression or unacceptable toxicity is encountered. Study population: The~     investigators will include 20 postmenopausal metastatic breast cancer patients with an AR~     positive, HER2 negative tumor. Patients should be restaged clinically with bone scintigraphy~     and CT scan within a 6 week timeframe of the PET examinations. Intervention: All patients~     will receive a baseline FDHT-PET scan and start with bicalutamide treatment 150mg daily.~     During follow-up patients will receive one FDHT-PET scan after 6 weeks. Treatment with~     bicalutamide will continue until progression or unacceptable toxicity is encountered. Main~     study endpoint: The percent difference in 18F-FDHT uptake in tumor lesions after 6 weeks of~     monotherapy bicalutamide. A minimum decrease of 20% in 18F-FDHT uptake after 6 weeks compared~     to baseline uptake with an α of 0.05 and a power of 80%, is considered clinical significant.~   "
66463|NCT02697019|"~     The primary aim is to investigate the effectiveness of an Internet-delivered Emotion~     Regulation Individual Therapy for Adolescents (ERITA) with nonsuicidal self-injury (NSSI).~   "
66464|NCT02697006|"~     The purpose of this study is to collect prospective safety and performance information for~     the i-COR® device using synchronized cardiac assist in the setting of combined heart-lung~     failure or in high risk percutaneous intervention procedures in catheterization lab.~   "
66465|NCT02696993|"~     There are 2 parts to this research study: Part 1 (dose escalation) and Part 2 (dose~     expansion).~      The goal of Part 1 of this clinical research study is to find the highest tolerable dose of~     nivolumab that can be given either with radiation therapy alone or in combination with~     radiation and ipilimumab, in patients with NSCLC. The goal of Part 2 of this study is to~     learn if the dose of nivolumab found in Part 1 when given with radiation therapy and~     ipilimumab can help to control the disease.~      This is an investigational study. Both WBRT and SRS radiation are FDA approved for local~     control of metastatic and primary tumors. Nivolumab is FDA approved and commercially~     available for the treatment of melanoma and NSCLC. Ipilimumab is FDA approved and~     commercially available for the treatment of melanoma. It is considered investigational to use~     radiation therapy, nivolumab, and ipilimumab to treat NSCLC. The study doctor can explain how~     the study drugs are designed to work.~      Up to 80 participants will take part in this study. All will be enrolled at MD Anderson.~   "
66639|NCT02694692|"~     The primary aim for this study is to determine if maternal Kangaroo Care (KC) provided during~     painful procedures in early life will mitigate stress release and will improve~     neurobehavioural outcomes in infants, decrease subsequent pain response, and enhance~     maternal-child interaction beyond the period of hospitalization.~   "
66466|NCT02696980|"~     The purpose of this study is to test the effect of increasing lung volume with a simple~     hand-held device to both prevent, and also to relieve, airway constriction in people with~     asthma and a BMI ≥ 35 kg/m2.~      Twenty people with late onset non-allergic asthma and a BMI of ≥ 35 kg/m2 will be recruited.~     The efficacy of elevating lung volume on both preventing and reversing bronchoconstriction~     will be tested. Lung volume will be modulated by breathing out against a small level of~     resistance (positive expiratory pressure).~   "
66467|NCT02696967|"~     The purpose of this study is to determine the safety and tolerability of CLR325 in heart~     failure patients to determine if further clinical development of the drug in this indication~     is warranted.~   "
66468|NCT02696954|"~     Primary Objective~        -  To characterize the potential pharmacokinetic interactions of artemether -lumefantrine,~          amodiaquine and primaquine in healthy adult subjects.~      Secondary Objectives~        -  To characterize the pharmacokinetic properties of artemether-lumefantrine, amodiaquine~          and primaquine when given alone and in combination.~        -  To evaluate the safety and tolerability of co-administered artemether-lumefantrine,~          amodiaquine and primaquine.~        -  To investigate pharmacogenetic polymorphisms affecting drug levels of~          artemether-lumefantrine, amodiaquine and primaquine and their metabolites.~   "
66469|NCT02696941|"~     SGLT2 inhibitors have been proven to be effective in several preclinical rodent models of~     non-alcoholic fatty liver disease (NAFLD). Using a choline deficient diet to recapitulate~     some of the histological features of human non-alcoholic steatohepatitis (NASH), it was found~     that 5 weeks of SGLT2 inhibition led to significant reductions in hepatic triglyceride~     content and improved markers of liver fibrosis. Similarly, 4 weeks of treatment in obese mice~     led to improved glucose tolerance, reduced hepatic steatosis and reduced markers of liver~     oxidative stress in a dose dependent manner. These findings corresponded with an improvement~     in traditional liver function tests including the aminotransferases (ALT and AST). The widely~     used antidiabetic agent metformin has been shown in rodent models to increase hepatic insulin~     sensitivity and lower liver fat content which is in contrast to the findings in humans where~     metformin increases hepatic insulin sensitivity, reduces body weight but does not decrease~     liver fat content. The reason for the discrepancy between the animal and human studies, with~     regards to liver fat content remains unclear.~      The investigators hypothesise the following:~        -  SGLT2 Inhibitors have the potential to decrease lipid accumulation in the liver through~          reduced de novo lipogenesis (DNL)~        -  There will be no decrease in endogenous lipid synthesis (DNL) with metformin and thus no~          change in liver fat content.~      There are two arms to this study.~        -  Arm 1: x10 participants with poorly controlled type 2 Diabetes (T2DM) who have been~          recommended to start an SGLT2 inhibitor called dapagliflozin will be recruited.~        -  Arm 2: x13 participants with insulin resistance who have not yet started any diabetic~          medication will be recruited and will be prescribed metformin at standard clinical~          doses.~      The two arms will run in parallel and all participants will undergo identical investigations~     before and after 3 months of treatment with either dapagliflozin or metformin. Investigations~     will include liver magnetic resonance imaging/spectroscopy, fat biopsy, fat microdialysis~     sampling, two-step hyperinsulinaemic euglycaemic clamp, breath sampling and stable glucose~     and palmitate isotope infusions.~      The investigators aim to show that SGLT2 inhibition decreases liver fat whereas we aim to~     demonstrate why liver fat remains unchanged in humans, treated with metformin. These data~     will provide the first evidence for the use SGLT2 inhibitors in NAFLD, and will be highly~     informative for the design of future clinical studies. Moreover, the data gained from the~     metformin arm of the study will provide the first mechanistic evidence in humans of the~     effects of metformin on hepatic fatty acid metabolism.~   "
66470|NCT02696928|"~     Feasibility of methylene blue-based combination therapy in the radical treatment of adult~     patients with Plasmodium vivax malaria in Ethiopia: a randomised controlled pilot trial~      Study rationale:~      Elimination has become the goal of malaria programmes in an increasing number of endemic~     countries and regions. Primaquine (PQ) is the only registered drug for radical cure of~     Plasmodium vivax malaria. Prolonged PQ-based combination therapy carries safety concerns and~     resistance to chloroquine (CQ) and PQ is emerging. Methylene blue (MB) has recently been~     shown to be safe and effective in the treatment of Plasmodium falciparum malaria in West~     Africa. As there is evidence for MB probably being effective against the hypnozoites of~     Plasmodium vivax, MB-based drug regimens could be an alternative to PQ-based combination~     therapy in Plasmodium vivax malaria.~      Study objectives:~      The main objective of this trial is to study the feasibility of MB-based combination therapy~     in patients with uncomplicated P. vivax malaria in an endemic area of Ethiopia.~   "
66471|NCT02696915|"~     Fracture femur is a common injury which is associated with excruciating pain. Positioning for~     neuraxial blocks is always challenging because even slight overriding of the fracture ends is~     intensely painful .It can causing major patient distress which accompanied by well-known~     physiological sequelae such as sympathetic activation causing tachycardia, hypotension, and~     increased cardiac work that may compromise high-risk cardiac patients.~      Fascia iliaca compartment block is highly effective in blocking lateral cutaneous nerve of~     the thigh and femoral nerve. Fascia iliaca compartment block is not only easy to perform but~     it is also associated with minimal risk as the local anesthetic is injected at a safe~     distance from the femoral artery and femoral nerve. It is always safe to perform the fascia~     iliaca compartment block prior to spinal anesthesia as the patient can respond during~     administration of the local anesthetic and can prevent intra-neuronal injections~   "
66472|NCT02696902|"~     Clinical Trial looking to Evaluate the Efficacy and Safety of MEDI3902 in Mechanically~     Ventilated Patients for the Prevention of Nosocomial Pneumonia Caused by Pseudomonas~     aeruginosa~   "
66473|NCT02696889|"~     The ROSE study is designed to determine the efficacy of bone marrow derived stem cell therapy~     on ovarian function recovery in subjects with idiopathic and other types of premature ovarian~     failure (POF)~   "
66474|NCT02696876|"~     This is a proof-of-concept study to determine the safety and efficacy of a novel device to~     increase the reparative capacity of the knee. The discovery of a resident population of~     mesenchymal stem cells (MSCs) within synovial fluid (SF) was the first description of this~     reparative cell population having direct access to superficial cartilage and joint~     structures. The ready access of SF MSC to cartilage and other joint tissues offers a novel~     strategy for joint repair. Current arthroscopic procedures result in the removal of all SF~     MSCs due to continuous irrigation throughout the procedure. The current study would benefit~     the patient by greatly increasing the reparative capacity of the joint by bolstering MSC~     numbers and retaining those MSCs within the joint after surgery. By accessing MSCs from the~     synovium it is anticipated that these cells would be entrapped/migrate into the marrow clot~     formed by microfracture of the sub-chondral bone. These MSCs would supplement those from the~     marrow and may result in faster, better quality repair.~   "
66475|NCT02696863|"~     The main objective is to identify obstacles and elements facilitating the implementation of a~     tracking device Broncho Pulmonary Cancer during the course of care.~      The secondary objective is to assess patient knowledge and information received on their~     previous occupational exposure during their professional activity.~      This is a prospective multicenter study of qualitative methodology through in-depth~     interviews conducted with patients treated at ICLN and CHU Saint-Etienne~   "
66477|NCT02696837|"~     In prospective, safety-control study; children undergoing laparoscopic inguinal hernia repair~     using PIRS (Percutaneous Internal Ring Suturing) method will be randomly assigned into four~     groups. Gr 1: Endotracheal intubation and muscle relaxant, Gr 2: Endotracheal Intubation~     without muscle relaxant, Gr 3: Proseal Laryngeal Mask Airway without muscle relaxant, Gr 4:~     Proseal Laryngeal Mask Airway with subparalytic does muscle relaxant. Apart from standard~     monitorization, all patients' intragastric pressures will also be monitored. Patients' age at~     presentation, gender, time of surgery, time of anesthesia, intragastric pressure,~     intraabdominal pressure, intraoperative findings and complications will be noted and compared~     between groups.~   "
66478|NCT02696824|"~     The purpose of this study is to conduct a two-arm effectiveness trial in Cape Town, South~     Africa of a Xhosa-adapted, nurse-delivered, cognitive behavioral therapy (CBT) treatment for~     depression and adherence, integrated into the HIV care setting in patients with HIV who did~     not achieve viral suppression from first-line treatment. The CBT treatment will be compared~     to enhanced usual care (Enhanced Treatment As Usual - ETAU) on study endpoints (as described~     in study endpoints section below).~   "
66479|NCT02696811|"~     Studies have shown that certain compounds inside vegetables can reduce the risk of cancer.~     Carrots in particular have an association with reduced incidence of colorectal, bladder and~     breast cancer. Compounds in carrots, called polyacetylenes, have been studied in isolated~     cells that have shown a reduction in cancer cells as well as inflammatory markers which have~     been associated with an increased risk of cancer. These polyacetylenes have not been well~     studied in the human body and it is unclear whether they are able to affect the biomarkers of~     health (disease) including DNA damage and inflammatory markers. The aim of this research~     project is to determine whether eating a portion of white carrots every day for 6 weeks can~     lead to a reduction in DNA damage and inflammatory markers compared to a control period of 6~     weeks consuming a polyacetylene-free diet and a control food of a high fibre oat biscuit.~   "
66480|NCT02696798|"~     The main purpose of this study is to evaluate the efficacy and safety of ixekizumab in tumor~     necrosis factor (TNF) inhibitor-experienced participants with radiographic axial~     spondyloarthritis (rad-axSpA).~   "
66481|NCT02696785|"~     The main purpose of this study is to evaluate the safety and efficacy of the study drug known~     as ixekizumab in biological disease-modifying anti-rheumatic drugs (bDMARDs)-naive~     participants with radiographic axial spondyloarthritis (rad-axSpA).~   "
66482|NCT02696772|"~     Long term maintenance of weight loss is generally poor, which is at least partly due to~     increased feelings of hunger associated with restricting what can be eaten. Intermittent~     severe energy restriction is a novel dietary strategy that requires individuals to consume a~     very-low energy diet for 1-4 days per week, allowing normal feeding patterns to be adopted on~     the other days in the week. However, the effect of a consuming a very-low energy diet on~     appetite regulation, which might represent a key marker of long-term adherence to dieting,~     has not been determined. This study aimed to assess the effects of severely restricting~     energy intake for 24 h on markers of appetite regulation, energy balance and metabolism~     compared to an adequate energy trial.~   "
66483|NCT02696759|"~     The purpose of this research is to test whether bacteria that normally live in the intestines~     play a role in fighting cancer. It is believed that the development and behavior of these~     immune cells may be influenced by bacteria and other microorganisms living in the gut. In~     turn, the activities of these immune cells could work with anti-cancer therapies to make them~     more, or less, effective.~   "
66484|NCT02696746|"~     To understand the pathophysiological basis of heritable pain syndromes. This will consist of~     a number of components:~        -  Determine the genetic basis for heritable pain syndromes.~        -  Investigate the pain symptoms, psychological co-morbidity and quality of life in~          patients with heritable pain syndromes.~        -  Use quantitative sensory testing to investigate abnormalities in sensory processing.~        -  Use imaging modalities to investigate the neural correlates of pain perception in~          heritable channelopathies.~        -  In select patients to perform skin biopsy to determine if there has been any damage to~          C-fibres.~        -  To perform skin biopsy in order to culture fibroblasts and neural crest stem cells for~          future studies into the molecular basis of altered pain perception.~        -  To use neurophysiological tests, the axon reflex, and conditioning challenges to~          determine how peripheral nerves, in heritable channelopathies and unusual pain~          syndromes, have been altered.~        -  Microneurographic recordings for directly detecting the function of pain fibres in~          peripheral nerves. Knowledge gained from the study will be used to aid the further~          development of genetic testing and specific pain questionnaires for the diagnosis of~          heritable pain syndromes secondary to channelopathies.~        -  Ultimately better knowledge of underlying pathophysiology in these heritable pain~          conditions may inform the development of novel treatments.~   "
66485|NCT02696733|"~     Obturator nerve block is an effective method to prevent adductor muscles contraction during~     transurethral resection of bladder tumour localized on the lateral wall. Due to prior spinal~     anaesthesia the patient does not feel uncomfortable during the blockade and the interadductor~     approach gives the possibility to perform it in the lithotomy position. The aim of the study~     was to evaluate the safety and effectiveness of ultrasound-guided obturator nerve~     identification and blockade for TURBT.~   "
66511|NCT02696395|"~     Hip replacements are being performed on an increasingly active population, who are likely to~     wear their implants out prematurely. New hip replacements have been devised to minimise the~     risk of failure. DePuy RSA RCT is a randomised controlled trial designed to compare the~     performance of two established types of hip replacements using Corail and Tri-Lock stems~     along with Deltamotion acetabular component. The primary objective of the trial is to compare~     the long term stability of these two devices.To do this, the study will use an advanced 3D~     Xray technique to detect migration of the components at 3 years. The study will also measure~     micromotion of Corail, Tri-Lock and Deltamotion components, patient reported outcome measures~     and change in bone density.This study is being conducted at a single site, at the Nuffield~     Orthopaedic Centre, Oxford.~   "
66652|NCT02694523|"~     This is a randomized double blind, double dummy, active comparator controlled, parallel~     design study that is performed to assess the safety and efficacy of BI 655066/ABBV-066~     (risankizumab) compared to adalimumab to support registration for the treatment of moderate~     to severe chronic plaque psoriasis in adult patients.~   "
66486|NCT02696720|"~     Phantom limb pain (PLP) and scar hyperalgesia (SH) are frequent problems after amputation; in~     particular most persons who undergo limb amputation will experience phantom pain. The~     neuropathic nature of PLP suggests the involvement of both peripheral and central~     neurological mechanisms, including neuroplastic changes in the central nervous system. PLP as~     other central nervous system-related pain syndromes remains a challenge for treatment. Scar~     hyperalgesia involves peripheral mechanisms and results frim the production of substances~     liberated by damaged skin cells. These inflammatory substances lower the pain threshold by~     altering the chemical environment of skin nerve endings. Scan hyperalgesia is associated with~     secondary mechanical hyperalgesia in the skin area around the scar.~      The lidocaine patch 5% is a topical analgesic acting by blocking sodium channels of~     peripheral nerve endings and by inhibiting ectopic discharges in sensitized and hyperactive~     cutaneous nociceptors. The patch is noninvasive, with minimal systemic absorption resulting~     in a reduced risk of drug-drug interaction. In addition, a central analgesic effect of~     lidocaine has been suggested. The lidocaine patch 5% is currently licensed for the treatment~     of symptomatic postherpetic neuralgia. It also has been successfully used in patients with~     other neuropathic pain states, such as entrapment neuropathies, painful idiopathic distal~     sensory polyneuropathies and postoperative/post traumatic neuropathic chronic cutaneous pain.~     The lidocaine patch has not been studied for the management and prevention of phantom limb~     pain.~      The aim of the present research is to investigate if a lidocaine patch 5% is effective for~     reducing PLP and primary/secondary scar hyperalgesia. The hypothesis is that persistent~     peripheral nociceptive input from the stump after surgery may drive maladaptive cortical~     reorganization leading to chronic central pain and thus promote chronic phantom limb pain.~     Treating scar hyperalgesia on the stump with topical lidocaine may reduce the activity of~     peripheral nociceptive afferents and thus decrease the likelihood of developing persistent~     phantom limb pain.~      This study is designed as a randomized controlled multicentric double blind trial, in which~     the effectiveness of applying a 5% lidocaine patch for 6 weeks will be compared with a sham.~   "
66487|NCT02696707|"~     Several large adjuvant trastuzumab trials have demonstrated improved overall survival, in~     participants with early stage breast cancer, with a 33% decrease in risk of death. However,~     retrospective analyses of participant outcomes in these trials have demonstrated increased~     risk of cardiotoxicity (i.e damage to the heart) in a small number of patients (4-8%).~      At this time, investigators are unable to predict which participants are at increased risk of~     cardiac-related treatment complications. Currently all patients receive regular cardiac~     imaging throughout their one year of trastuzumab treatment.~      At this time, the optimal monitoring schedule for trastuzumab-related cardiotoxicity remains~     unknown, and several published consensus guidelines are currently in use as standard of~     care.~   "
66488|NCT02696694|"~     This study aims to investigate the impact of serum progesterone concentrations on the day of~     embryo transfer in egg donation cycles under hormonal replacement therapy. As secondary~     outcomes, the investigators will investigate if endometrial volume measured by~     three-dimensional (3D) ultrasound on the day of embryo transfer is related with progesterone~     levels and with chances of pregnancy.~   "
66489|NCT02696681|"~     Project AProaCH is an open pilot trial of a cognitive behavioral therapy (CBT) for~     individuals with HIV with various psychological comorbidities, which the investigators call~     syndemics. Syndemics are co-occurring psychosocial problems that interact with each other~     and with health behavior such as HIV sexual transmission risk behavior and adherence to self~     care.~   "
66490|NCT02696668|"~     This study's main aim is to compare the effect of a modified FaME vs. a multisensory balance~     exercise programme on falls risk, balance confidence and quality of life in older adults who~     fall or at risk of falling when implemented in a group setting.~   "
66491|NCT02696655|"~     (i) To develop a behavioural intervention that supports healthcare professionals to~     effectively deliver lifestyle behaviour change of patients undergoing liver transplantation~      (ii) To assess the acceptability and feasibility of the behavioural intervention during~     routine practice~   "
66492|NCT02696642|"~     To characterize the safety, tolerability, pharmacokinetics and immunogenicity of anetumab~     ravtansine in subjects with advanced solid cancers and with different degrees of hepatic or~     renal impairment~   "
66493|NCT02696629|"~     The prevalence of OSA is 3.5~4.6% in Chinese adults. OSA leads to repetitive hypoxemia,~     hypercapnia, and arousal from sleep and is an independent risk factor for hypertension,~     stroke, coronary artery disease and congestive heart failure. CPAP is the first-line~     treatment for OSA. But many patients do not adhere to therapy.~      The upper airway(UA) anatomical abnormality is a prominent risk factor in Asian OSA patients,~     which might be improved by surgical strategies. However, surgery shows variable clinical~     effectiveness. One important reason for patients responding poorly to single treatment~     procedure is that multiple abnormal physiological traits contribute to OSA.~      High loop gain is one of the key non-anatomical risk factors. It will be useful to~     individualize therapy in OSA by better understanding the reversibility of increased LG, the~     interaction of LG and UA anatomical change as well as the condition that trigger reduction of~     LG.~      The project will test the hypothesis of 1) Elevated LG is induced in some patients and is~     reversible by treatment of OSA; 2) Change of LG is related to the improvement of sleep apnea;~     3) An elevated LG is related to residual sleep apnea after upper airway surgery, which might~     be eliminated by adjunct CPAP therapy after surgery. The results would improve the efficiency~     of non-CPAP treatment and provide a potential combined treatment option for those patients~     with both elevated loop gain and anatomy risk factors in the Asian population.~   "
66494|NCT02696616|"~     Investigation of safety and tolerability of BI 655088 following intravenous infusion of~     single rising doses and exploration of the pharmacokinetics and pharmacodynamics of BI 655088~     after single dosing~   "
66495|NCT02696603|"~     The purpose of this study is to understand variation in the symptoms of Parkinson disease.~     This study uses an iPhone app to record these symptoms through questionnaires and sensors.~   "
66496|NCT02696590|"~     This study aimed to evaluate oral and injectable routes in treatment of hypovitaminosis D in~     multiple sclerosis (MS) patients. The investigators aimed to assess the efficacy of each~     method, using the same Mega dose of 600 000 IU D3, in achieving normal serum 25(OH)D level,~     the durability of the response, the practicality and the possible toxicity.~   "
66512|NCT02696382|"~     The investigators plan to test an innovative, home-based, short duration, high intensity~     exercise program designed for application in the immediate post-hospitalization period in~     older Veterans. Preliminary data suggest a more intensive approach to physical therapy in~     older adults after hospitalization is safe and maximizes mobility more than usual care. The~     Veterans participating in the high intensity exercise program will receive therapy utilizing~     higher resistance exercises. Outcomes from this group will be compared to data collected from~     the patients receiving standard, lower resistance therapies.~   "
66513|NCT02696369|"~     This study is Phase 4 trial which evaluates the safety and efficacy of 2% Lidocaine HCl with~     different epinephrine concentration in patients undergoing surgical extraction of impacted~     lower third molars~   "
66497|NCT02696577|"~     Intrauterine growth restriction is a common and complex obstetric problem. Intrauterine~     growth restriction is noted to affect approximately 10-15 % of pregnant women. Intrauterine~     growth restriction is diagnosed antenatal; however, some of these fetuses, especially if~     unscreened during pregnancy, may be detected only in the neonatal period. It is very~     important for obstetricians and perinatologists to identify growth restricted fetuses,~     because this fetal condition is associated with significant perinatal morbidity and~     mortality.~      Omega 3 is composed of polyunsaturated fatty acids with a double bond at the third carbon~     atom from the end of the carbon chain. The fatty acids have two ends, the carboxylic acid~     end, which is considered the beginning of the chain, thus alpha, and the methyl end, which~     is considered the tail of the chain, thus omega. Omega3 improve fetal wellbeing by two~     mechanisms: Firstly, maternal and docosahexaenoic acid supplementation during pregnancy and~     lactation normalizes intrauterine growth restriction induced changes in adipose deposition~     and visceral PPARγ expression. Secondly, maternal docosahexaenoic acid supplementation~     increases serum adiponectin, as well as adipose expression of adiponectin and adiponectin~     receptors. Novel findings suggest that maternal docosahexaenoic acid supplementation~     normalize adipose dysfunction and promote adiponectin-induced improvements in metabolic~     function in intrauterine growth restriction~   "
66498|NCT02696564|"~     A randomized, parallel, placebo controlled trial to evaluate the effect of 100mg/day losartan~     on the progression of emphysema as measured by quantitative HRCT compared to placebo~   "
66499|NCT02696551|"~     This is a retrospective and prospective designed study, included hospitals are 1:1 assigned~     into two groups: ①Interventional hospital, which will receive 3-month medical education;~     ②Non-interventional hospital, which will not receive 3-month medical education. During 1~     month before education, all the electronic records of outpatients and inpatients who visit~     the included rheumatologists will be collected and the data of test and evaluation results of~     spondyloarthritis (SpA) patients diagnosed according to new Assessment of Spondylo-Arthritis~     International Society (ASAS) criteria will be collected from outpatient electronic records~     and inpatients medical charts; in the 3 months after education, the same data will be~     collected and compared with the data before education, and the impact of medical education on~     physician behaviour will be analyzed. Meanwhile, the understanding and acceptance level will~     be evaluated by the questionnaire, the differences before and after education and the impact~     of education on physician cognition will be evaluated.~   "
66500|NCT02696538|"~     The purpose of this research study is to investigate how useful three balance tests are in~     predicting fall risk in the individual with traumatic brain injury (TBI). These tests are the~     Functional Gait Assessment (FGA), the Berg Balance Scale (BBS), and the mini-Balance~     Evaluation Systems Test (mini-BESTest).~   "
66501|NCT02696525|"~     Conduct a prospective study to confirm blood and urine ctDNA detection value in~     non-small-cell lung cancer patients.~   "
66502|NCT02696512|"~     This is a study to evaluate the safety and efficacy of the IBRF ACP/MCP intervention protocol~     in patients with severe disorders of consciousness (SDOC).~   "
66503|NCT02696499|"~     This is a randomized, double blind, placebo-controlled, parallel-arm, multi-center, Phase 2,~     proof-of-concept efficacy and safety study in patients with end-stage renal disease requiring~     hemodialysis.~      The purpose of the study is to determine the efficacy and safety profile of PA101B delivered~     via eFlow high efficiency nebulizer in patients with uremic pruritus who are symptomatic~     despite using standard treatments.~   "
66504|NCT02696486|"~     The purpose of this is to develop and implement a pilot study that will demonstrate the~     ability to recruit, enroll, retain, conduct exercise training, and collect pre and post~     outcomes on the effect of exercise training on quality of life (QOL) and exercise capacity in~     patients with a diagnosis of heart failure with preserved ejection fraction (HFPEF).~   "
66505|NCT02696473|"~     Polyacetylenes, compounds found naturally in carrots, have shown promising anti-cancer and~     anti-inflammatory actions in vitro but have not been tested in vivo. To determine whether the~     polyacetylenes could have an effect in vivo, this study aims to determine whether they are~     detectible in human biofluids after the consumption of a portion of carrots and whether a~     difference is seen between a large and small portion.~   "
66506|NCT02696460|"~     Adequate analgesia in serial chronic leg ulcer debridement can be difficult to achieve. A~     common analgesia method is the topical administration of local anesthetics directly onto the~     wound. However, complete wound debridement is often hampered by insufficient analgesia~     leading to interruption of the actual debridement and fragmentation of treatment into more~     frequent serial debridement sessions. Alternatively, the inhalation of an nitrous~     oxide/oxygen (N2O/O2) gas premix could be used for analgesia. In this study, the~     investigators have compared the analgesic method of an eutectic mixture of topically~     administered lidocaine/prilocaine cream (EMLA®) with the inhalation of an equimolar 50%~     N2O/50% O2 gas premix (Kalinox®) in serial leg ulcer debridement.~   "
66507|NCT02696447|"~     The aim of the present study is to determine the frequency and to identify main risk factors~     for venous thromboembolism of venous thromboembolic complications in a population of cancer~     patients treated with a curative intent by ionizing radiation.~   "
66508|NCT02696434|"~     This study will evaluate the efficacy, safety, and tolerability of oral naltrexone used in~     conjunction with buprenorphine in adults with Opioid Use Disorder transitioning from~     buprenorphine maintenance prior to the first dose of VIVITROL.~   "
66509|NCT02696421|"~     Ramadan fasting entails abstinence from eating and drinking between dawn and sunset. During~     this month major changes in meal times and patterns, sleeping times and activity occur.~     Starvation is known to lead to a compensatory reduction in energy expenditure. However, the~     Ramadan fast is not synonymous with starvation as it involves intermittent periods of fasting~     followed by gorging. People who fast during Ramadan feel less energetic. However, little is~     known about the effects of this religious practice on energy metabolism. .~      The aim of this study is to assess energy dynamics before and/or after and during Ramadan~     fasting in non-obese participants. Resting metabolic rate (RMR), thermic effect of food~     (TEF), active energy expenditure (AEE) and total energy expenditure (TEE) in free-living~     conditions will be measured . Indirect calorimetry will be used to assess RMR and TEF, doubly~     labeled water will be used to measure TEE and activity monitors will measure physical~     activity. In addition, body composition analysis will be performed by bio-electrical~     impedance. Blood sample will be taken to exclude medical factors affecting energy metabolism.~   "
66514|NCT02696356|"~     This is a study of an investigational cancer vaccine called GRN-1201. Treatment with the~     GRN-1201 vaccine is a type of immunotherapy. The goal of immunotherapy is to stimulate the~     body's immune system (white blood cells) to attack cancer cells and kill them. GRN-1201~     consists of 4 different peptides (small parts of proteins) that are expressed by melanoma~     cells. The intent of treatment with GRN-1201 is to increase your body's immune response to~     melanoma.~      To further increase your body's immune response against tumor cells, the GRN-1201 vaccine~     will be mixed with Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF, also known as~     sargramostim). GM-CSF is a man-made protein that helps stimulate the immune system and~     increase the response against the tumor cells. This is a phase I study which means that this~     will be the first time GRN-1201 is given in combination with GM-CSF to humans. It will be~     tested in a small number of people to evaluate its safety, find a safe dose, and identify~     side effects. The safety of GRN-1201 will be tested at three different doses; the GM-CSF dose~     will remain the same.~   "
66515|NCT02696343|"~     Two innovative approaches, pulsatile orocutaneous entrainment of non-nutritive suck via~     orosensory entrainment (NTrainer) device technology and serial salivary gene expression~     analyses, will be merged to examine the relation between gene expression, oral somatosensory~     stimulation, feeding behavior, and neurodevelopmental outcomes at 18 months corrected age~     (CA) on 180 extremely preterm infants [EPIs] (24 0/7-26 6/7 GA and 27 0/7 - 28 6/7 GA)~     enrolled at three neonatal intensive care units: Catholic Health Initiative (CHI) Health St.~     Elizabeth (Lincoln, NE), Tufts Medical Center (Boston, MA), and Santa Clara Valley Medical~     Center (San Jose, CA). EPIs will be randomized to a blind pacifier (SHAM) or PULSED NTrainer~     treatment groups, and stratified by GA, sex, and bronchopulmonary dysplasia status (BPD vs~     non-BPD). We hypothesize that the combination of the NTrainer® intervention for improved oral~     feeding skills, along with objective salivary gene expression data to monitor response to~     treatment and feeding development, will result in a novel, objective, and personalized~     approach to neonatal oral feeding and reduce the duration of time to attain oral feeds while~     improving feeding, growth and neurodevelopmental outcomes at 18 months' CA.~   "
66516|NCT02696330|"~     Comparison between effect of enoxaparin and clopidogrel on improving pregnancy rate in ICSI~   "
66517|NCT02696317|"~     The purpose of this study is to evaluate the performance of two commercially-available~     silicone hydrogel contact lenses in normal and low humidity environments after at least 7~     days of wear.~   "
66518|NCT02696304|"~     Along with the improvement of childhood acute leukemia treatment, survival rates have~     increased. Therefore, the number of long term childhood leukemia survivors has increased~     progressively over the last decades. So, the assessment of long term health status in this~     population becomes very important. Many studies have shown an increased risk of life~     threatening late complications and early mortality. Cardiovascular morbidity and mortality~     are particularly frequent. Among these late complications, the metabolic syndrome (MS) is an~     important concern since it is associated with cardiovascular morbidity and mortality. The~     overall MS prevalence in the French prospective cohort of survivors of childhood acute~     leukemia was 9.2% and 18.6% in cases of total body irradiation (TBI) during the leukemia~     treatment. Since the median age at MS evaluation was 21 years, this prevalence was very high.~     Anyway, the MS pathophysiology in this population is still poorly understood. One of the most~     recent hypothesis about the MS mechanism is based on the adipose tissue inability to store~     fatty acids: when adipose tissue cannot expanse further to store excess nutriments then~     lipids accumulate in other tissues. This ectopic lipids accumulation can cause insulin~     resistance and MS.~      The investigators hypothesized that the adipose tissue could be damaged by treatments~     received during childhood acute leukemia treatment (particularly TBI). This leads to~     morphological and functional abnormalities that could promote the insulin resistance and MS.~      This ectopic adipose tissue contains less preadipocytes, which could impair its functional~     properties.~      The primary endpoint of this study is to compare the morphological and functional~     characteristics of adipose tissue in patients with a MS who received or not TBI during~     childhood leukemia treatment . This comparison will focus on:~        -  The adipose tissue repartition and evaluation of the ectopic adipose tissue~        -  Fibrosis and inflammation of the adipose tissue~        -  Preadipocytes quantification~      The secondary endpoint is to describe:~        -  for the whole cohort of included patients,~        -  the clinical and biological characteristics associated with the MS.~        -  Cardiovascular risk factors and nutritional statement~        -  Anthropometric measurements~        -  Detection of other endocrinal abnormalities possibly associated with the MS~        -  Analysis of inflammation blood markers and adipokines quantification.~   "
66519|NCT02696291|"~     The purpose of this study is to evaluate the safety and pharmacokinetics of UV-4B oral~     solution when administered to healthy subjects three times a day (TID) for 7 days.~   "
66520|NCT02696278|"~     The goal of this study is to examine the effect of increasing children's intake of fiber and~     unsaturated fat, through daily servings of hummus and vegetables, on their microbiome~     profile.~   "
66521|NCT02696265|"~     Objective: The purpose of this study is to compare the efficacy and safety of ablation of~     Atrial Fibrillation (AF) drivers marked by spatiotemporal dispersions and Complex~     Fractionated Atrial Electrocardiograms (CFAEs) to Pulmonary Vein Isolation (PVI) based~     ablation in patients with persistent AF.~      Hypothesis: CFAE/spatiotemporal dispersion guided ablation will increase AF free survival~     compared to a PVI guided ablation.~      Patient population: Patients with persistent AF will be randomized based on a 2:1 ratio into~     one of two study arms:~        -  CFAE/spatiotemporal dispersion guided ablation: CFAE mapping and ablation during AF~          aimed at restoring sinus rhythm during ablation.~        -  PVI guided ablation: wide antral pulmonary vein isolation during mapping catheter~          control of pulmonary vein signals~   "
66522|NCT02696252|"~     Comparison of G5® Mobile Continuous Glucose Monitoring System Accuracy When Using an~     Automated Applicator vs. a Manual Sensor Applicator~   "
66523|NCT02696239|"~     The purpose of this study is to evaluate the impact of implementing different types of~     suturing materials and techniques of vaginal cuff closure in robotic assisted laparoscopic~     hysterectomy on cost, operative time and post operative surgical outcomes.~   "
66524|NCT02696226|"~     This is a prospective, randomized pilot study in patients undergoing Sugical Aortic Valve~     Replacement (SAVR) and Transcatheter Aortic Valve Replacement (TAVR) to estimate the~     incidence of reduced leaflet motion and assess the impact of perioperative anticoagulation on~     the incidence of reduced leaflet motion.~   "
66525|NCT02696213|"~     Systematic, Comprehensive, One-to-One Training (SCOOT) for Scooter Skills, is a novel,~     community-based, client-centred intervention where skills training is incorporated into~     social activities that users want to perform. The trainer also offers problem solving~     strategies to help manage environmental barriers and to promote social participation. This~     intervention is different from customary scooter training in that customary training is often~     very limited and focuses on learning discrete skills outside of the user's normal~     environment. The purpose of this study is to explore the feasibility of conducting a~     mixed-methods, rater-blinded, randomized controlled trial (RCT) for new scooter users, which~     will evaluate the efficacy of SCOOT. We anticipate that the feasibility outcomes will be~     strong enough to support the conduct of a subsequent multi-site trial with a sufficient~     sample size to enable us to quantify definitive outcomes such as adverse events (e.g.,~     injuries and abandonment).~   "
66526|NCT02696200|"~     Significant morbidity, mortality, and related costs are caused by traumatic brain injury~     (TBI). An externally-worn medical device that applies mild jugular compression according to~     the principle of the Queckenstedt Maneuver (the Device). Preliminary research suggests that~     the Device has the potential to reduce the likelihood of TBI. The currently developed collar~     has been approved for studies in humans and the results indicate safety for use during high~     demand and maximal exertion activities, This study will investigate the effectiveness of this~     device in high school athletes playing a collision sport such as football. The use of helmets~     during such a high-risk sport will allow for collision measurement devices to be embedded in~     the helmet and will not affect play or fit of equipment. Athletes participating in this study~     will be randomly assigned to one of two groups: 1) Device wearing during the season or 2)~     Non-device wearing during the season. The helmets of all participants will be outfitted with~     an accelerometer which will measure the magnitude of every impact to the head sustained by~     the athlete. Effectiveness of the device will be determined via differences in longitudinal~     brain imaging and functional testing following competitive football participation. A subset~     of athletes who report a diagnosed concussion will also receive additional brain~     neuroanatomical and neurophysiological testing within a week following the diagnosed~     concussive event. The purpose of the study is to monitor longitudinal changes in brain~     structure and function between the preseason and postseason, in a population of football~     playing athletes wearing the Device and compared to a similar population not wearing the~     device. Secondly, the purpose is to determine the protection of the device relative to amount~     and magnitude of sustained head impacts.~   "
66527|NCT02696187|"~     This study evaluates the effects of KOL-webben (the COPD web), an interactive web-based~     system directed towards two target groups; people with chronic obstructive pulmonary disease~     (COPD) and health professionals in primary care. KOL-webben include tools that improve health~     literacy with a specific focus on 1) increased physical activity and 2) use of appropriate~     self-management strategies. Moreover, KOL-webben include knowledge and tools directed towards~     staff in the primary care aimed to implement provision of evidence based health promotion~     interventions.The feasibility and effects of KOL-webben will be evaluated.~   "
66528|NCT02696174|"~     This is the Phase 3 of a 3 phase study to determine the feasibility, acceptability and~     effectiveness of a health microinsurance scheme in improving health equity and clinical~     outcomes for private primary care (PPC) in Kuala Lumpur, Malaysia. This two-arm, pre-post,~     quasi-experimental trial consisted of utilizing a HMI scheme (experimental clinic) and normal~     OOP payments (control clinic) for 6 months. The HMI scheme enabled subscribed households to~     access a defined benefit package at a selected PPC for treatment and follow-up.~   "
66529|NCT02696161|"~     Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with~     involving compression of the median nerve in the carpal tunnel. Rather than other progressive~     disease, CTS is characterized by remission and recurrence. Although many conservative~     managements of CTS, the effectiveness of these methods is insignificant or only persist for a~     short duration. The platelet rich plasma (PRP) is a new and potential treatment for patients~     with kinds of musculoskeletal disorders and recent reports showed being beneficial for~     peripheral neuropathy in animal studies. Since 2014, two small clinical trials showed the~     positive effect of PRP in peripheral neuropathy. One study shown the PRP has therapeutic~     effect for peripheral neuropathy in patients with leprosy. In addition, PRP having protective~     effect against neurological deficit of facial nerve during superficial parotidectomy.~     However, these studies have not entirely proved the effects of PRP on peripheral neuropathy~     because these studies enrolled small number of patients and lacked controlled design. In~     addition, the PRP was not used for treating CTS so far. The investigators design a~     randomized, double-blind, controlled trail to assess the effect after ultrasound-guided PRP~     injection in patients with CTS.~   "
66530|NCT02696148|"~     This trial is conducted in the United States of America. The aim of this trial is to~     investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the~     body) and pharmacodynamics (the effect of the investigated drug on the body) of liraglutide~     in obese children aged 7 to 11 years~   "
66531|NCT02696135|"~     Hypertrophic cardiomyopathy (HCM) is one of the most common inherited cardiac diseases, with~     a prevalence of ∼0.2%. Sudden cardiac death (SCD), heart failure and stroke are the major~     poor outcomes of HCM. Although about half of the patients were found to be caused by~     mutations mainly located in genes encoding sarcomere proteins, the causes in a significant~     proportion of patients with HCM are still unknown. Even in the patients with sarcomere~     mutations, the molecular pathways that eventually lead to cardiac hypertrophy are remained to~     be revealed. Furthermore, HCM presents with significant heterogeneity. SCD risk~     stratification and prevention by ICD are necessary. However, the strategy of SCD risk~     stratification recommended by the 2011 ACCF/AHA and 2014 ESC guidelines were based mainly on~     the evidence derived from American and European countries. The accuracy of these guidelines~     in Chines patients with HCM was not evaluated yet.~   "
66544|NCT02695966|"~     This is a single-centre, prospective, non-randomised research study. The research team will~     investigate the feasibility of assessing primary human pancreatic tissue for changes to T~     lymphocyte function and localisation in the presence and absence of AMD3100.~   "
66545|NCT02695953|"~     Posttraumatic stress disorder (PTSD) is a significant personal and societal burden. The~     purpose of this study is to examine genetic, epigenetic, behavioral, and brain activity~     changes related to PTSD dysfunction and recovery before and after treatment with Cognitive~     Processing Therapy.~   "
66546|NCT02695940|"~     This is a phase 2a trial testing twice daily administration of LEO 124249 ointment 30 mg/g in~     the treatment of mild to moderate inverse psoriasis. Patients will be treated for 6 weeks,~     and the efficacy and safety will be compared with the treatment of LEO 124249 ointment~     vehicle.~   "
66547|NCT02695927|"~     This project is designed to test a lightweight, portable, computerized pair of glasses that~     will help reduce some of the cognitive deficits seen in patients who have suffered damage to~     their right cerebral hemisphere.~   "
66548|NCT02695914|"~     The purpose of this study is to observe inflammatory markers like TNF (tumor necrosis~     factor), IL-1 (interleukin-1), IL-6 (interleukin-6),TREM-1 (triggering receptor expressed on~     myeloid cells-1), etc, in patient of FUO with excess-heat syndrome and the influence of~     Compound Qingre Granule on the inflammatory markers.~   "
66532|NCT02696122|"~     Different anesthetic techniques have been proposed for carrying out Inguinal hernia repair,~     including local anesthesia, regional and general. There are no recent data on the application~     of a validated questionnaire to assess which anesthetic technique, local infiltration under~     general anesthesia or spinal anesthesia, would provide better quality of recovery in the~     opinion of the patients undergoing inguinal hernia repair. The aim of the study is to perform~     a randomized clinical trial comparing the quality of recovery (QoR-40) after local~     infiltration under general anesthesia via laryngeal mask (LMA) or spinal anesthesia for~     unilateral inguinal hernia repair. METHODS - Seventy patients aged 18 to 65 years old, who~     were scheduled to undergo unilateral inguinal hernia repair at Santa Lucinda Hospital will be~     enrolled in the study. The anesthesia will be performed according to the following sequence:~     L Group - intravenous (I.V.) propofol and alfentanyl, followed by LMA positioning. The~     anesthesia will be maintained by propofol. For local anesthesia, approximately 50 ml of 0.5%~     ropivacaine will be infiltrated along the line of incision in the subcutaneous plane,~     followed by peripheral nerve block technique (e.g., ilioinguinal-hypogastric nerve block) and~     local wound infiltration at the fascial level. S Group - spinal puncture followed by~     intrathecal 15 mg of 0.5% hyperbaric bupivacaine injection and sedation with propofol by~     continuous infusion. Pain will be assessed every 15 minutes at Post-anesthesia Care Unit~     (PACU) using a 0-10 numeric pain rating scale and I.V. morphine will be administered to~     maintain the pain score below 4. The QoR-40 will be administered by a blind investigator 24~     hours after surgery.~   "
66533|NCT02696109|"~     The purpose of this study is exploring a theoretically guided intervention, Cornerstone,~     which provides system 'boundary-spanning' services, including therapeutic services and~     mentorship, to transition-age youth with mental disorders. Cornerstone is designed to improve~     mental health service engagement and outcomes. The study uses a mixed methods approach to~     refine Cornerstone, and a hybrid design examining feasibility, acceptability, and preliminary~     impact with a randomized trial, alongside implementation.~   "
66534|NCT02696096|"~     This study proposes to use functional magnetic resonance imaging (FMRI) to observe brain~     activity and behavior associated with decision-making about rewards (DD task), working memory~     and working memory cognitive persistence (WM task), and craving (CR task) in 72 opiate~     dependent participants initiating buprenorphine. While stably using opiates (initial study~     appointment) and again during withdrawal (approximately 3 days later), participants will~     receive an FMRI scan with behavioral challenges; immediately after the second FMRI, they will~     receive their first dose of buprenorphine. Buprenorphine treatment will continue for twelve~     weeks, followed by a four week taper. Urine toxicological analysis will be performed prior to~     the first scanning session, weekly for two weeks and biweekly thereafter.~      Participation for all individuals will last 4 months. Assessments will occur at baseline, and~     weeks 1, 2, 4, 8, and 12. Buprenorphine induction will begin at the completion of the second~     scan; follow-up medical visits will align with study assessments on weeks 1, 2, 4, 8 and 12.~     All participants will receive 16 weeks of buprenorphine (the final 4 of these 16 weeks will~     include a taper).~   "
66535|NCT02696083|"~     To investigate the effect of PEMF treatment when administered twice daily over a 90-day~     period by looking at synovial fluid in subjects with osteoarthritis of the knee.~   "
66536|NCT02696070|"~     This study is designed to evaluate the effectiveness of the Provant Therapy System in~     improving localized nerve growth and skin perfusion in subjects with painful peripheral~     diabetic neuropathy of the foot.~   "
66537|NCT02696057|"~     Identification of the effects of spinal stabilization exercises and manual therapy methods on~     pain, function and quality of life in individuals with low back pain.~   "
66538|NCT02696044|"~     The aim of this study is to evaluate the safety and tolerability of triheptanoin in~     participants with Rett syndrome using laboratory values, electrocardiogram, rate of adverse~     events (AE), and physical exam.This study also seeks to evaluate the efficacy of UX007~     (triheptanoin) in improving overall seizure frequency and dystonia.~   "
66539|NCT02696031|"~     To demonstrate the clinical efficacy, safety and tolerability of secukinumab compared to~     placebo in patients with non-radiographic axial spondyloarthritis at Week 16 as well as week~     52 and long term efficacy and safety up to Week 104.~   "
66540|NCT02696018|"~     Acute respiratory failure (ARF) is characterised by a discrepancy between load imposed on~     respiratory muscles and their capacity. Recently, diaphragmatic ultrasonography has been~     introduced in the clinical practice to evaluate diaphragmatic function. In particular, the~     investigators will focus on Diaphragmatic Displacement measured by M-mode ultrasonography.~     The aim of this study was to compare the diaphragmatic displacement with traditional weaning~     parameters in potentially ready to be extubated patients undergoing a spontaneous breathing~     trial (SBT).~   "
66541|NCT02696005|"~     30 patients suffering from Heart Failure with Ejection Fraction less than 40% start Cardiac~     Rehabilitation Programme, serum KLOTHO Hormone level and other labs and Echo measurements~     will be taken on the first visit.~      After completion of 3-month Rehabilitation Programme the second set of labs and Echo~     measurements will be taken.~      Than participants will be divided for 2 groups: the patients who wish to continue~     Rehabilitation programme for additional 3-month period and the second group that prefer to~     stop Rehabilitation programme after completion of the first 3 month period.~      For both groups additional set of labs will be taken this time and at the end of the study.~      The Aim of the study: to investigate association between serum KLOTHO level, physical~     activity and possible correlation with laboratory and echocardiographic parameters in cohort~     of Heart Failure patients.~   "
66542|NCT02695992|"~     The RATAF II study is a randomized, prospective, parallel group study, designed to compare~     the effects of two different drug regimens for rate control in permanent AF (atrial~     fibrillation). We will investigate on the difference in effects on exercise capacity,~     biomarkers (NT-proBNP (N-terminal pro-brain natriuretic peptide), troponins, hs-CRP), heart~     rate, echocardiographic measurements and symptoms.~      Our main hypothesis is that six months' treatment with the calcium channel blocker diltiazem~     will lower NT-proBNP and increase exercise capacity (peak VO2) compared to treatment with the~     beta blocker metoprolol in permanent AF.~   "
66543|NCT02695979|"~     Collecting blood, graft liver effluent and urine samples from patients undergoing orthotopic~     liver transplantation.~   "
66549|NCT02695901|"~     Although several studies have assessed the efficacy of chlorhexidine in treating gingivitis~     and reducing biofilm formation, the side effects of a long-term use are unpleasant for~     patients. Melaleuca alternifolia oil has been considered as an alternative because of its~     anti-inflammatory properties. However, little is know about the efficacy of its~     nanoparticles. The purpose of this study is to compare the effect of 0.12% chlorhexidine~     (Periogard ®) and a nanoparticle solution of 0.3% M. alternifolia oil in reducing biofilm~     formation in plaque-free and plaque-covered teeth surfaces.~   "
66550|NCT02695888|"~     This research study examines the feasibility of using an in-vehicle mobile technology~     monitoring system to measure teen secondary task engagement during on-road driving as the~     outcome measure for a web-based intervention to prevent risky driving in novice teen drivers.~   "
66551|NCT02695875|"~     Fibromyalgia is a disease whose incidence rate is increasing and causing a severe disability~     to those who suffer it. Currently, other treatment resources are being implemented, such as~     aquatic therapy. This therapy seems to provide positive results in different dimensions of~     fibromyalgia.~      The main objective of the study is to determine the effectiveness of a physical therapy~     program in warm water vs. land-based therapy in women with fibromyalgia for pain reduction~     and improvement balance at the end of treatment and a month and a half later (follow-up).~      The type of study is a randomized controlled opened trial. The sample is composed of 34 women~     with age between 35 and 64 years and fibromyalgia diagnosis who will be divided into 2~     groups: Aquatic Therapy Group (n=17) and Land-Based Therapy Group (n=17). This study will~     have two primary outcomes: Pain and balance. The intensity of pain will be assessed using the~     visual analog scale (VAS) and the pain threshold for each one of the 18 tender points will be~     assessed using a electronic algometer. Static balance will be evaluated with the Romberg's~     test and the dynamic balance with the Timed Up & Go test (TUG) and Berg Balance Scale. Both~     type of balance will be recorded in slow motion and then, will be analysed with a motion~     software. Secondary outcomes are: The impact of fibromyalgia on patient's lives, that will be~     measured with the Revised Fibromyalgia Impact Questionnaire (FIQR); the sleep quality, that~     will be assessed with the Pittsburgh Sleep Quality Index (PSQI); the fatigue, that will be~     evaluated witn the Multidimensional Fatigue Inventory (MFI); the physical capacity, that~     will be measured with the six minute walk test (SMWT) and confidence in balance that will~     be assessed with the Activities-specific Balance Confidence scale (ABC).~      Each intervention will last one hour and will be made 3 times a week for three months . It~     will consist of 4 sections: Warming, exercises for static and dynamic balance training,~     stretching and relaxation. Statistical analysis will be made using the Statistical Package~     for the Social Sciences software, version 21.0 for Windows. p ≤ 0.05 will be the significance~     level set for all analysis.~   "
66552|NCT02695862|"~     The study is single centered; prospective, parallel arm randomized controlled trial.The~     patients will be who presented to Institute of Liver & Biliary Sciences with esophageal~     variceal bleeding or develop esophageal bleeding during hospital stay. All patients will be~     managed with continuous non-invasive cardiac and hemodynamic monitoring including cardiac~     rhythm, pulse rate, blood pressure, and oxygen saturation. Hemoglobin (Hb) will checked every~     6 h for the initial 48 h and then every 12 h till discharge. Likewise, serum creatinine will~     checked daily. Packed red blood cells will be transfused to maintain target Hb of ⩾8 g/dl.~     Patients will be started on IV Proton Pump Inhibitor, with bolus dose of terlipressin (2mg)~     followed by Endoscopic variceal ligation. All patients will received prophylactic~     antibiotics; antibiotics will be stopped if there will no other indication to continue. After~     confirmation of EVB (Esophageal Variceal Bleeding) and successful initial hemostasis with~     emergency EVBL (Endoscopic Variceal Band ligation), patients will be randomly assigned into~     Group -A (Bolus terlipressin at 2mg every 4hourly) and Group-B (Continuous infusion of~     terlipressin @ 4mg/24hour initially) therapy for esophageal varices . They will then undergo~     HVPG (Hepatic Venous Pressure Gradient) measurement at baseline, 12hours and 24hours. Patient~     in continuous group will titrate dose. accordingly to HVPG (Hepatic Venous Pressure Gradient)~     measurement at 12 and 24 hours. At 24 hours patient will be directed to receive either TIPS~     (Transjugular Intrahepatic Portosystemic Shunt) or will continue Terlipressin for 48 hours.~   "
66553|NCT02695849|"~     This is a non-interventional, local, multicenter, cross-sectional study to determine the~     prevalence of epidermal growth factor receptor (EGFR) mutations in participants diagnosed~     with non-squamous non-small cell lung cancer (NSCLC).~   "
66554|NCT02695836|"~     This project will evaluate three different strategies to get research findings back to~     managers of care units in nursing homes. Feedback will be provided in a timely and effective~     way so that it results in improvements in organizational context (modifiable features of the~     care unit work environment, such as Formal Interactions, Informal Interactions, Social~     Capital or Slack Time), quality of care providers' work life (e.g., burnout, job~     satisfaction, general health) and quality of care. Three feedback packages will be tested to~     determine the strategy that is most effective at fostering improvements and is also~     cost-effective. The project will be carried out in nursing homes in Alberta and British~     Columbia. The information developed will contribute to better care for Canadian seniors who~     spend their final years in a nursing home.~   "
66555|NCT02695823|"~     Acute or chronic liver failure (fulminant hepatitis or advanced cirrhosis) disrupts brain~     physiology. Beyond classical hepatic encephalopathy, intracranial hypertension may~     occur.During liver transplantation (LT) surgery, many factors can lead to cerebral assault.~     In addition, intracranial hypertension measured with invasive methods has been described in~     certain phases of LT, especially at the time of reperfusion.~      The invasive monitoring of the intracranial pressure is not used in these patients, due to a~     high risk of infection and bleeding. The non-invasive monitoring of intracranial pressure has~     been widely developed in recent years : transcranial doppler and recently ultrasound of the~     optic nerve sheath (ONSD) allow an effective detection of intracranial hypertension.~   "
66556|NCT02695810|"~     The overall objective is to compare the short-term (3 months) effectiveness of three~     glucose-lowering interventions (dapagliflozin, metformin and physical activity) on glucose~     variability, body composition, and cardiometabolic risk factors in overweight or obese~     individuals with pre-diabetes (HbA1c 5.7-6.4% / 39-47 mmol/mol).~   "
66557|NCT02695797|"~     The purpose of the study is to investigate effect of immunotherapy in intractable cryptogenic~     epilepsy patients with autoimmune antibody.~   "
66583|NCT02695446|"~     The primary objective of this study is to evaluate the skin and plasma concentrations of~     minocycline in subjects undergoing treatment of acne vulgaris with oral extended release~     minocycline. Acne lesion counts and safety/tolerance of the treatment will also be evaluated.~   "
66584|NCT02695433|"~     The primary goal is to to characterize the effects of consuming 1 avocado fruit 7 days / week~     (5-7 days is acceptable) compared to a no avocado relatively low fat, carbohydrate control~     treatment over a 12 week period on insulin sensitivity as measured by the Matsuda composite~     index of insulin sensitivity (MISI).~   "
66558|NCT02695784|"~     The influence of the preterm gut microbiota in health and disease has been well established.~     However, relatively little is known about how the microbiome changes after discharge and its~     relationship with growth, health and disease outcomes in the preterm population. This study~     aims to follow a cohort of preterm infants and explore the relationship of the later~     microbiome ('after discharge') with later growth and health outcomes in infancy. The study~     will also explore the effect of timing of stopping routinely administered probiotics on the~     post-discharge microbiome, infant feeding and outcomes such as colic.~      The investigators aim to longitudinally follow 40 infants born before 32 weeks gestation who~     have also taken part in the investigators microbiome study during their NICU stay (SERVIS REC~     No: 10/H0908/39) and where microbiomic sampling has been adequately achieved. The~     investigators will collect stool at and beyond the time of anticipated discharge (beyond 34~     weeks) targeted to include pre- and post-weaning, and again at a year. Actual discharge~     timing of these infants varies, and is usually latest in the most immature infants, allowing~     an assessment of the influence of physical location (NICU vs home) as well as increasing age.~     Using 16S ribosomal RNA amplicon analysis, the investigators will assess bacterial~     colonisation of the gut and measure infant weight, length and head circumference at each time~     point. The investigators will use a parent questionnaire to assess daily crying time,~     parents' perceptions of colic severity using a visual analogue scale as well as vomiting and~     constipation for the two weeks before sampling.~   "
66559|NCT02695771|"~     To compare the efficacy of Mitomycin C vs. Gemcitabine vs. no adjuvant treatment as a single~     intraoperative instillation in preventing recurrence of bladder cancer.~   "
66560|NCT02695758|"~     A non-blinded randomized controlled trial, in which participants undergoing primary reverse~     or total shoulder arthroplasty are randomly assigned to one of two treatment groups.~   "
66561|NCT02695745|"~     The purpose of this study is to characterize the heat pain tolerance threshold (HPTolTr) in~     primary hyperalgesic skin after topical capsaicin application, and to assess heat pain and~     mechanical thresholds (eg, pressure pain, stimulus-response) following skin sensitization by~     UVB (ultraviolet B) irradiation and topical capsaicin.~   "
66562|NCT02695732|"~     To compare the efficacy and safety of Carvedilol and endoscopic therapy in Primary~     Prophylaxis of High-risk Esophageal Gastric Variceal Bleeding.~   "
66563|NCT02695719|"~     The purpose of this study is to evaluate the efficacy and safety of oral administration of~     lubiprostone 24 μg twice daily (BID) for 4 weeks in participants with chronic idiopathic~     constipation (CIC) compared with placebo.~   "
66564|NCT02695706|"~     The measured product in this research is a product for topical use, Laboratoires~     Mercurochrome Reparador e Protetor. The expected benefit to the use of the product is the~     improvement in skin hydration as measured by self perception of participant research and~     clinical evaluation and improvement in local microcirculation, assessed by instrumental~     measurements in feet of the study participants.~   "
66565|NCT02695693|"~     Computer assisted interventions are becoming very popular as an intervention strategy for~     students with autism. There is little data on how effective they are or how their~     implementation affects teachers' use of other evidence-based practices. The proposed study~     would be the first to examine these questions in a community setting.~   "
66566|NCT02695680|"~     Real-time optical surface monitoring data will be acquired from 44 human patients with~     primary or metastatic lung lesions during and after their 4DCT scan (standard-of-care at our~     institution). A patient-specific 4D model will be developed using the raw 4DCT projections~     time-correlated with real-time surface monitoring. In addition, before delivering each dose~     fraction (3 - 5 for lung SBRT), we will acquire three 15s kV fluoroscopic image acquisitions,~     time-correlated with optical surface monitoring. The acquisitions will be distributed over~     three well-spaced beam angles, e.g., every 4th angle for a 12-field plan.~   "
66567|NCT02695667|"~     Quantitative Genioglossal muscle strength in Obstructive Sleep Apnea (OSAS) defined in the~     clinical spectrum of subjects with Snoring Disturbance, Oral Appliance Therapy Responsive,~     and CPAP Responsive~   "
66568|NCT02695654|"~     Adductor canal block has become popular as effective mean for pain relief following knee~     surgery.This block has not been checked in chronic pain patients.The purpose of this study is~     to assess the efficacy and safety of adductor canal block on chronic knee pain in patients~     with knee osteoarthritis.~   "
66569|NCT02695641|"~     The primary purpose of this pilot study is to assess the pharmacokinetic profile of low-dose~     bevacizumab and its effectiveness in reducing plasma free VEGF-A levels safely in~     hemodialysis patients. This information will be used to plan a phase 1 clinical trial~     evaluating bevacizumab's role in hemodialysis vascular access failure.~   "
66570|NCT02695628|"~     This clinical trial studies how well 18F-fluoromisonidazole ([18F]FMISO) positron emission~     tomography (PET)/computed tomography (CT) works after transcatheter arterial embolization in~     imaging tumors in patients with liver cancer. Transcatheter arterial embolization blocks~     blood flow to tumor cells by inserting tiny foreign particles into an artery near the tumor.~     [18F]FMISO is a type of radioimaging agent that binds to large molecules in tumor cells that~     have a low level of oxygen, and the radiation given off by [18F]FMISO is picked up by a PET~     scan and this may help researchers learn whether changes occur in the tumors after treatment,~     which can help decide how well the treatment worked earlier than is currently possible~   "
66571|NCT02695615|"~     We investigated a correlation between maternal anxiety and age, body mass index (BMI),~     parity-gravidity, patient satisfaction, antenatal care, postoperative pain according to~     emergent or elective C/S under general anesthesia.~   "
66572|NCT02695602|"~     This is a prospective, patient blinded, randomized, clinical trial enrolling patients with~     symptoms and signs of nasal obstruction related to enlarged inferior turbinates. The purpose~     of this study is to compare two different surgical methods, both of which are already in~     common use, for the treatment of nasal obstruction in patients with inferior turbinate~     hypertrophy.~   "
66585|NCT02695420|"~     - To evaluate pharmacokinetics (PK) of omecamtiv mecarbil in Japanese subjects with heart~     failure (HF) with reduced ejection fraction; - To evaluate the safety and tolerability of~     oral omecamtiv mecarbil~   "
69083|NCT02662712|"~     The purpose of this study is to evaluate pharmacokinetics and safety data including serious~     and other adverse events, physical examinations, vital signs, 12-lead electrocardiograms~     (ECGs) and clinical laboratory results (including biochemistry, hematology, and urine).~   "
66573|NCT02695576|"~     Title and abstract~      1 a. Title: Lumbar fusion or non-operative care for treatment of presumed discogenic pain.~      A randomized study.~      1 b. Structured summary:~      Authors: B. Nyström, B. Schillberg, E. Svensson, T. Stiles.~      Corresponding author: Bo Nyström, Clinic of Spinal Surgery, Strängnäs, Sweden. e-mail~     address: pgbo.nystrom@gmail.com~      Background: At present there is no clear evidence that surgical treatment by fusion operation~     is more advisable than non-surgical treatment in patients suffering from unspecific chronic~     low back pain (CLBP). By personal experience a subgroup among the CLBP patients is selected,~     possibly representing patients with pain from a motion segment/disc, thus making patient~     selection more specified. Furthermore, selection of level to fuse based on radiological~     findings has not been found reliable. Therefore a mechanical provocation test has been~     developed at the clinic. The aim of this randomized study was to compare the outcomes in pain~     and pain related functions perceived by this specific subgroup of CLBP patients following~     fusion surgery with those following non-surgical treatment.~      Methods: Patients with a specified symptomatology and specified clinical signs at examination~     were recruited and randomized to either type of treatment, non-surgical (NS) including~     cognitive-behavioral therapy and physiotherapy (37 pat.) or surgical (S), including the same~     cognitive-behavioral therapy and physiotherapy as in the NS group plus fusion surgery (37~     pat.). All patients were thoroughly investigated before start of the study and at follow-up~     one year after treatment. The outcomes perceived by the patients were assessed on the~     validated questionnaires Oswestry Disability Index (ODI), Roland-Morris, Balanced Inventory~     for Spinal Disorders (BIS), Short-Form-36 (SF-36) and Euro-Quol (EQ-5D).~   "
66574|NCT02695563|"~     The aim of the study is to evaluate the effect of vaginal lactoferrin administration on~     amniotic fluid PGE2 level and MMP-TIMP system in women undergoing genetic amniocentesis. Two~     groups of patients will be prospectively enrolled: not treated with lactoferrin and treated~     with vaginal lactoferrin 4 hours prior to mid-trimester genetic amniocentesis.~   "
66575|NCT02695550|"~     This is a Phase I study of the ALK/FAK/Pyk2 inhibitor CT-707 in patients with ALK-positive~     non-small cell lung cancer.~      The purpose of the study is to determine the MTD/RP2D of CT-707 and evaluate whether CT-707~     is safe and has beneficial effects in ALK-positive advanced non-small cell lung cancer.~   "
66576|NCT02695537|"~     The purpose of this study is to evaluate the safety and tolerability of Epidiolex at various~     doses between 5 mg/kg/day and 50 mg/kg/day as an additional (add-on) drug for treating~     debilitating, drug-resistant epilepsy.~   "
66577|NCT02695524|"~     This study evaluate the effectiveness of adding neuromuscular exercises with tactile, visual~     and auditory feedback to a strengthening exercises protocol, both emphasizing the~     periscapular muscles on improvement of disability in patients with shoulder impingement~     compared to patients receiving only strengthening exercise protocol.~   "
66578|NCT02695511|"~     The primary aim of this NIA sponsored ancillary study of phase 2 CALERIE is to measure~     whether metabolic adaptation lasts up to 2 years in response to a 25% calorie restriction in~     normal-weight and slightly overweight individuals. Energy metabolism (24-hour sedentary and~     sleeping) will be measured in a respiratory chamber. Other measures include the activities of~     the sympathetic nervous and thyroid axes, oxidative stress in lipids, protein and DNA, organ~     size by MRI and echocardiography, and posture allocation (time spent engaging in different~     activities and the energy expended during these activities), and activity temperament (the~     innate predilection for movement). This set of studies will allow assessment of whether the~     previously observed metabolic adaptation in response to 25% caloric restriction is long~     lasting (up to two years), associated with reduced thyroid and sympathetic activities and~     reduced oxidative damage. The studies of organ sizes (liver, spleen, kidney, heart, adipose~     and muscle) by MRI and echo (heart) is essential to determine whether the metabolic~     adaptation is related to decreased organ sizes or improved organ energy metabolism~     efficiency. The above described measures will be performed at baseline and after 1 and 2~     years of a 25% caloric restriction in 50 non-obese humans and in 25 sex-, BMI- and age-~     matched subjects who will not engage in caloric restriction.~   "
66579|NCT02695498|"~     Although many adults with migraines use non-pharmacological treatment options, there is a~     lack of research on the use of many mind/body techniques specifically for headache. This~     research will further the understanding of the mechanisms, efficacy, and predictors of~     mind-body practices in adults with migraines.~   "
66580|NCT02695485|"~     A retrospective study is conducted with 151 patients who has a soft tissue defect of digit~     treated with the sensate flaps from February 2005 to March 2014. Based on the different~     regions of soft tissue defects, the patients in the study are divided into four groups: (1)~     thumb group treated with the bilaterally innervated and traditional kite flaps; (2) distal~     finger group treated with the single- and dual-innervated dorsal digital flaps; (3) proximal~     finger group treated with heterodigital neurocutaneous island flap; and (4) awkward region~     group treated with Litter flap. The main outcomes are static 2-point discrimination and~     Semmes-Weinstein monofilament scores of the flap, and pain and patient satisfaction.~   "
66581|NCT02695472|"~     The study will consist of a screening period and a randomized treatment. Approximately 220~     subjects who meet eligibility during the screening period will be randomized to initiate a~     12-week, double-blind treatment with NSI-189 80 milligrams/day (provided as 40 milligrams~     twice per day), NSI-189 40 milligrams once a day, or placebo.~   "
66582|NCT02695459|"~     Phase II, open-label, multicentre national study. Patients with metastatic neuroendocrine~     carcinomas of extrapulmonary origin will be eligible. Treatment will be performed as~     indicated in the section Investigational drug and reference therapy. Cisplatinum and~     everolimus dosing is based upon earlier phase 1 studies (Fury et al. 2012). CTs will be done~     at 9 weekly intervals (after 3 courses of chemotherapy;). Patients will be treated until~     documented progression according to RECIST 1.1. Enrolment is expected to take between 14 - 16~     months. The total study duration is estimated to be 2 to 3 years until publication. Three NET~     centres in The Netherlands will participate, (Erasmus Medical Center in Rotterdam,~     Netherlands Cancer Institute in Amsterdam and , the University Medical Center of Groningen) A~     pre-treatment (and optional post-treatment) tumour biopsy will be included for DNA/RNA~     analyses and organoid culture. An additional 5cc of blood will be withdrawn as a germline DNA~     reference. A second 5 cc of blood will be included for measuring circulating tumour~     transcripts to identify all types of GEP-NET (NETTest).~   "
66586|NCT02695407|"~     Cardiac output monitoring devices are commonly used in ICU patients. The most precise use~     direct measurement, which require artery cannulation. The gold standard is Swan-Ganz~     catheter, but it is a very invasive technique. PiCCO (Pulse index Continuous Cardiac Output)~     is the alternative way of haemodynamic monitoring. This technology is the easy, less invasive~     and cost-efficient tool for determining the main hemodynamic parameters of critically ill~     patients. It is based on two physical principles - transpulmonary thermodilution and pulse~     contour analysis. Both principles allow the calculation of haemodynamic parameters in~     critically ill patients. PiCCO method requires peripheral artery cannulation.~      Cannulation may be followed by artery stenosis.~      Aims of the study are:~        1. to verify the occurrence of radial artery stenosis after 3 days of having a PiCCO~          cannula in place.~        2. whether 5 days cannulation of radial artery with PiCCO catheter is related to more~          frequent stenosis rate.~      An additional assessment:~      1. to check whether the eventual stenosis is still present after 3, 14 and 30 days after~     decannulation - assessment depending on patients availability~   "
66587|NCT02695394|"~     The aim of this prospective non-interventional neuropsychological one visit study involving~     functional MRI (fMRI) is to ascertain emotional processing in patients with Multiple~     Sclerosis (MS) or Clinically Isolated Syndrome (CIS) compared to healthy control subjects.~      In different experiments, the modulation of cognitive and motor responses by visual emotional~     information and the ability to discriminate visual emotional stimuli will be tested using~     experimental behavioral paradigms. Furthermore, functional connectivity and - using fMRI -~     activations of brain regions known to be involved with emotional processing will be~     evaluated.~   "
66588|NCT02695381|"~     This study evaluate the efficacy and safety of Etodolac-lidocaine topical patch applied one~     time daily when compared with placebo in the treatment of acute Delayed Onset Muscle Soreness~     (DOMS) of the upper limbs.~   "
66589|NCT02695368|"~     The study is a multicenter, double-blind, randomized, controlled trial conducted at six major~     university and teaching hospitals with a catchment population of approximately 2 million. In~     the current study it has been hypothesized that a non-invasive air cleaner utilizing a plasma~     chamber can significantly reduce the incidence of surgical site infections (SSIs).~   "
66590|NCT02695355|"~     The purpose of this study was to see if the clinical outcome of stimulant medication~     (methylphenidate) in pediatric Attention Deficit Hyperactivity Disorder can be predicted on~     the bases of changes in Event Related Potentials (ERPs) induced by a single dose of stimulant~     medication. (ERPs are extracted from electroencephalographic (EEG) registrations during the~     performance of an attention task).~   "
66591|NCT02695342|"~     There is a growing body of evidence demonstrating that older adults with COPD have important~     problems with their balance and a high incidence of falls compared to those of a similar age.~     This research will explore the feasibility and preliminary effects of a tailored 6-month home~     balance exercise program for reducing falls in older adults with COPD.~   "
66592|NCT02695329|"~     Purpose of this study is to determine the effectiveness of the KneeAlign 2 system in terms of~     precise implant alignment by demonstrating that KneeAlign 2 provides better tibial alignment~     compared to conventional instruments~   "
66593|NCT02695316|"~     The aim of this study is to describe access and communication barriers of migrant women who~     do not speak the local language in the Swiss maternity care service provision from the~     perspective of users, health care professionals and interpreters.~   "
66594|NCT02695303|"~     To evaluate the Sun Protection Factor (SPF) efficacy on human skin.~   "
66595|NCT02695290|"~     There is a medical need for improving treatment of poor performance status patients with EGFR~     driver mutations and documenting safety and tolerability of existing agents.~   "
66596|NCT02695277|"~     This is a prospective, randomized (2:1) multicenter trial to investigate the optimal~     treatment of Persistent and Longstanding Persistent AF referred for Radiofrequency (RF)~     ablation.The study objective is to compare the efficacy and safety of two interventional~     approaches, in preventing the recurrence of AF in symptomatic, drug refractory patients with~     persistent or longstanding persistent atrial fibrillation.~   "
66597|NCT02695264|"~     The purpose of this study is to prospectively evaluate the accuracy and safety of~     non-invasive intracranial pressure (ICP) measurements using the HeadSense-1000 (HS-1000)~     device compared to the current invasive external ventricular device (EVD) or parenchymal~     (bolt) monitoring devices in the pediatric population.~   "
66598|NCT02695251|"~     Renal functional reserve is defined as the glomerular hyper filtration induced by a protein~     load. Renal blood flow and Glomerular Filtration Rate (GFR) increase in response to a protein~     load. Renal functional reserve loss is associated with a persistent hyper filtration state,~     seen in first stages of diabetic nephropathy, leading to progression of Chronic Kidney~     Disease (CKD). This observation has lead to larger clinical studies that demonstrated the~     positive effects of protein restriction on kidney function, and allowed the scientific~     community to recommend low proteins diet (less than 0.8 g / kg/ day) to prevent CKD~     progression. Nevertheless, the precise mechanisms responsible for kidney hemodynamic and~     metabolic changes induced by a protein load, are debated. Uribarri et al have suggested that~     renal hemodynamic changes induced by a protein load are mainly due to the Advanced Glycation~     End Products (AGEs) content. Indeed, initial studies experimental conditions leading to the~     demonstration of renal functional reserve (amino acid or protein perfusion or cooked meat),~     were in fact responsible for an AGEs load, based on recent published data.~      The aim of this study is to determine whether AGEs alone or proteins in general are~     responsible for the mobilization of renal functional reserve, leading to the progression of~     CKD.~   "
66599|NCT02695238|"~     Superiority multicenter prospective randomized study on operative delivery (instrumental~     delivery or caesarean section) of prophylactic manual rotation in case of persistent~     occipital posterior presentation during the second stage of labor compared to expectant~     management. A 15% reduction of operative delivery (instrumental delivery or caesarean~     section) is attempt in the prophylactic manual rotation group.~   "
66623|NCT02694913|"~     This is a non-interventional, R01-funded pilot study that will identify serum and cellular~     markers in patients' blood samples that can be used as short-term biomarkers of rituximab~     response. We hypothesize that serum complement levels, activation of natural killer cells,~     and clearance of peripheral B-cells will be accurate biomarkers of rituximab response, and~     may be correlated with long-term outcomes.~   "
66600|NCT02695225|"~     Tobacco use remains a significant public health problem and is increasingly prevalent among~     vulnerable groups. Appalachians have a high prevalence of tobacco use and are at increased~     risk for tobacco-attributable diseases. The efficacy of a scientifically valid tobacco~     cessation treatment delivered to Appalachian smokers remains untested. Also, little is known~     about the association of social-contextual factors that may modify or mediate the success of~     an intervention. These factors may be of particular relevance among disadvantaged smokers.~     Geographical patterns of tobacco exposure may also influence one's ability to quit,~     especially in pro- tobacco regions like Appalachia. The purposes of this application are to:~     1) evaluate the efficacy of a lay-led (LL) intervention in promoting long term abstinence~     from tobacco; and 2) examine the association between 12 month abstinence and selected~     individual, interpersonal, organizational, neighborhood and community, and societal factors~     among adult Appalachian tobacco users exposed to a tobacco cessation intervention. A third~     aim is exploratory and includes the characterization of activity patterns using space-time~     measures among adult Appalachian tobacco users exposed to a tobacco cessation intervention.~     Using a group randomized trial design, 707 Appalachian residents from 6 intervention and 6~     control counties will be randomly assigned by county to receive the LL intervention or a~     control condition which includes proactive telephone counseling via the Ohio Quit Line. LL~     group participants will receive face-to-face counseling, supervised by a county health~     department nurse, and delivered by a trained lay educator. A county Extension agent will~     assist with recruitment and retention efforts in this project. Social-contextual factors will~     be assessed at a baseline interview administered to all participants. Space-time activity~     geographical patterns of pro- and anti-tobacco exposures, or features, will be described~     among selected participants in four counties during weeks 1, 6 and 12 of treatment. At end of~     treatment and 6 and 12 months, LL and control group participants will be reassessed for~     tobacco use via self-report and cotinine-validation. Secondary analyses will explore~     differential trends over time between the two arms of the study. In a subset of the sample,~     pro- and anti-tobacco exposures will be estimated during weeks 1, 6 and 12 of treatment.~   "
66601|NCT02695212|"~     The primary objective of this study is to evaluate the safety and efficacy of Apremilast in~     subjects with moderate Hidradenitis Suppurativa (HS).~   "
66602|NCT02695199|"~     To evaluate the benefits of laparoscopic Doppler ultrasound (LDU) assisted laparoscopic~     varicocelectomy (LV) and compare the surgical outcomes and complications between LDU assisted~     LV (LDU-LV) and microscopic subinguinal varicocelectomy for infertile patients with~     varicoceles.~   "
66603|NCT02695186|"~     Intestinal metaplasia is generally considered a precancerous lesion. Although it is~     associated with a very small increase of gastric cancer risk, European Endoscopic Society and~     other European academic companies highlighted the increased risk of cancer in patients with~     gastric atrophy and IM and the need for staging in cases with high-grade dysplasia.~      The production of ROS in the gastrointestinal tract (GI) and their role in the~     pathophysiology and pathogenesis of gastrointestinal diseases have not been studied~     sufficiently. In the plasma of patients, in the context of the sequence gastro oesophageal~     reflux-oesophagitis-metaplasia-dysplasia-adenocarcinoma, have been found simultaneous~     formation of DNA adducts and increased myeloperoxidase concentration, which are associated~     with oxidative stress, decreased antioxidant capacity (decreased glutathione~     concentration).These findings support the role of oxidative stress in the pathogenesis and~     malignant transformation.~      Metabolic Syndrome (MS) has been recognized as a pro-inflammatory, pro-coagulant state~     associated with increased levels of C reactive protein (CRP), interleukin (IL) 6 and~     plasminogen activator inhibitor (PAI) 1. It has been reported that the inflammatory and the~     pro thrombotic markers, which are associated with increased risk for cardiovascular disease~     and DM2, represent only a part of the relationship between IM and cardiovascular mortality.~      Several factors influence the pathogenesis of MS, as the pro-oxidant condition of such~     patients may increase the risk for developing symptoms and related chronic diseases such as~     DM2. Although the exact contribution of oxidative stress on every pathologic condition~     included in MS is difficult to determine definitively, it is certain that oxidative stress is~     particularly high in the MS.~      Regarding the relationship between MS and GI diseases, studies have reported that patients~     with MS are almost twice at risk for developing Barrett's esophagus.The relationship between~     MS, gastro-esophageal reflux disease (GERD), and the development of IM also requires well~     designed prospective studies. It seems however, to be a correlation between obesity and GERD,~     as well as between obesity and gastric adenocarcinoma~   "
66604|NCT02695173|"~     The objective of this study is to compare, by insulin use at the index date, the sex-specific~     incidence of hospitalization or emergency department (ED) visit for severe complications of~     urinary tract infections (UTI), defined as pyelonephritis and urosepsis, among patients with~     type 2 diabetes mellitus (T2DM) who are new users of dapagliflozin with those who are new~     users of antidiabetic drugs (ADs) in classes other than sodium-glucose cotransporter 2~     (SGLT2) inhibitors, insulin monotherapy, metformin monotherapy, or sulfonylurea monotherapy~   "
66605|NCT02695160|"~     The purpose of the study is to evaluate the safety, tolerability and effect on FIX antigen~     and activity levels of ascending doses of SB-FIX. SB-FIX is an intravenously delivered Zinc~     Finger Nuclease (ZFN) Therapeutic for genome editing. It inserts a correct copy of the Factor~     9 gene into the albumin locus in hepatocytes with the goal of lifelong therapeutic production~     of the Factor IX clotting factor.~   "
66606|NCT02695147|"~     A retrospective analysis of outcomes of all patients who received TAVI via the subclavian or~     direct aortic approach between January 2011 and January 2016~   "
66607|NCT02695134|"~     The purpose of the investigators proposed randomized, controlled study is to examine the~     effect of 6 one hour treatments of Healing Touch (HT) over 3 weeks on post-cardiac event~     patients, while they wait to enter a Cardiac Rehab (CR) program.Patients enrolled in the~     Scripps Center for Integrative Medicine (SCIM) Cardiac Rehab Program typically experience a~     waiting period of 3 weeks, or sometimes more, before starting the program.~      Secondary aims of the proposed study are to evaluate the effect of HT on CR program outcome~     measures of METs, BMI, physical and mental well-being, and attendance in this population.~      New participants in the CR program who qualify and agree to participate in the study will be~     consented and randomly assigned to the Intervention Group who will receive Healing Touch~     therapy, or to the Control Group, which will not receive HT.~      At baseline both groups will complete the Dartmouth Quality of Life and SF-36 Health Surveys.~     The questionnaires will be repeated at the end of the 3 week study period and at the end of~     the 3 months SCIM CR program.~      An effect size of 15% was chosen, with an alpha level of 0.05, 80% power, 95% confidence~     level, and using a two-tailed test, it was determined that a sample size of 56 patients in~     each group would be needed for between group comparisons. To account for potential attrition~     the study will enroll 124 subjects, 62 in each group.~      Our rationale is that Healing Touch, in addition to standard medical care will reduce~     post-cardiac event stress and anxiety symptoms in patients waiting to enter a cardiac rehab~     program, as measured by the Dartmouth Quality of Life Index and the SF36 questionnaire.~     Further, the investigators suggest that Healing Touch treatments will improve patient's final~     outcomes of the 12 week CR program.~   "
66624|NCT02694900|"~     The objective of this pilot study was to compare the manual chest compressions (CC) versus CC~     feedback device TrueCPR vs mechanical CC device LifeLine ARM during simulated pediatric~     cardiopulmonary resuscitation~   "
66625|NCT02694887|"~     The objective of the present project is to study the accuracy of capillary blood level~     measured by handheld lactate analyzers when compared with the reference methods~     e.g.venepuncture blood gas analyzer sample.~   "
66653|NCT02694510|"~     Urinary peroxides and plasma glutathione/glutathione disulfide (GSH/GSSG) ratio will be~     measured in preterm infants less than 32 weeks gestation before and 7 days after receiving~     either Light-protected (Group 1) or Light-exposed (Group 2) Total Parenteral Nutrition (TPN)~     solutions.~   "
66608|NCT02695121|"~     The primary objectives of this study are (1) to compare the incidence of breast cancer, by~     insulin use at cohort entry, among females with type 2 diabetes who are new users of~     dapagliflozin and females who are new users of antidiabetic drugs (ADs) in classes other than~     sodium-glucose cotransporter 2 (SGLT2) inhibitors, insulin monotherapy, metformin~     monotherapy, or sulfonylurea monotherapy and (2) to compare the incidence of bladder cancer,~     by insulin use at cohort entry and pioglitazone use, among male and female patients with type~     2 diabetes who are new users of dapagliflozin and those who are new users of ADs in classes~     other than SGLT2 inhibitors, insulin monotherapy, metformin monotherapy, or sulfonylurea~     monotherapy. Secondary objectives will compare, by insulin use at cohort entry, frequency of~     several measures of health care use, baseline characteristics, and incidence of selected~     other cancers in males and females between the two exposure cohorts.~   "
66609|NCT02695108|"~     Neck pain is a very common problem in the population. Most of the patients suffer from neck~     pain for long time and the problem becomes chronic. The investigators studied the effects of~     scapular stabilization exercise on mechanical neck pain.~   "
66610|NCT02695095|"~     To compare, by insulin use at the index date, the incidence of hospitalization for acute~     liver injury (ALI) among patients with type 2 diabetes mellitus who are new users of~     dapagliflozin with those who are new users of antidiabetic drugs (ADs) in classes other than~     sodium-glucose cotransporter 2 (SGLT2) inhibitors, insulin monotherapy, metformin~     monotherapy, or sulfonylurea monotherapy~   "
66611|NCT02695082|"~     To compare, by insulin use at the index date, the incidence of hospitalization for acute~     kidney injury (AKI) among patients with type 2 diabetes mellitus who are new users of~     dapagliflozin with those who are new users of antidiabetic drugs (ADs) in classes other than~     sodium-glucose cotransporter 2 (SGLT2) inhibitors, insulin monotherapy, metformin~     monotherapy, or sulfonylurea monotherapy.~   "
66612|NCT02695069|"~     The purpose of this study is to assess the efficacy of random placenta margin incision for~     hemorrhage control during cesarean section of complete placenta previa pregnancies.~   "
66613|NCT02695043|"~     The primary purpose of this research is to increase adherence to outpatient rehabilitation of~     chronically underserved individuals with traumatic brain injury (TBI). The intervention will~     be a TBI rehabilitation-focused education tool suitable for use with a wide variety of~     patients, including those with poor literacy skills and those with Limited English~     Proficiency (LEP), hereafter referred to as the Multimedia Multicultural Educational Program~     for TBI (MMEPT).~   "
66614|NCT02695030|"~     The MicroVention Low-profile Visualized Intraluminal Support (LVIS*) Device is intended for~     use with bare platinum embolic coils for the treatment of unruptured, wide neck (neck greater~     than or equal to 4 or a dome to neck ratio less than two), intracranial, saccular aneurysms~     arising from a parent vessel with a diameter of greater than or equal to 2.5mm and less than~     or equal to 4.5mm.~   "
66615|NCT02695017|"~     The investigator will proceed to assess changes in oxygenation of muscle tissue,~     electromyographic activation and strength in healthy subjects. For this, a measurement of all~     demographic variables on the first day of the study as well as a familiarity with the~     equipment will be performed. Participants will start the intervention 48 hours later to~     proceed with the first intervention with one of the exercises in this research (inertial~     pulley or regular machine). Later on, 48 hours later participants will perform the latest~     intervention that has not yet done, thus generating a crossover study.~   "
66616|NCT02695004|"~     This is a study to evaluate safety, tolerability and PK of DKF-310 IM injection in healthy~     male volunteers.~   "
66617|NCT02694991|"~     Effectively controlling sternal pain during cardiac rehabilitation after heart surgery is~     very important as it reduces the risk of postoperative complications.~      However, the contraindications and side effects of analgesic drugs may induce physicians to~     use them so cautiously that pain may actually be under-treated.~      The aim of this open label, controlled study is to assess whether osteopathic manipulative~     treatment (OMT) can contribute to pain relief and improve rehabilitation outcomes.~   "
66618|NCT02694978|"~     To evaluate the safety of 1.020 g of IV ferumoxytol compared to 1.500 g of IV Ferric~     Carboxymaltose (FCM).~   "
66619|NCT02694965|"~     Purpose of the study:~      The investigators are proposing that melanomas which respond and develop eventual disease~     stability in response to checkpoint inhibitor immunotherapy undergo a genetic program~     promoting secondary resistance.~   "
66620|NCT02694952|"~     Interventional, individually randomized, double (e.g. investigator and participant) blinded,~     parallel two-arm, non-inferiority trial to assess the efficacy of EchiTabPlus-ICP compared to~     FAV-Africa for the treatment of snakebite with envenoming.~   "
66621|NCT02694939|"~     The proposed study evaluates the effectiveness of a family-based psychosocial treatment~     program for teens with ADHD (Supporting Teens' Academic Needs Daily; STAND) developed to be~     delivered in community settings. STAND is BT enhanced by Motivational Interviewing (MI) that~     was developed (R34 MH092466) for teens with ADHD through a stakeholder informed process.~     STAND consists of ten 50-minute sessions delivered by therapists with community-typical~     levels of training and supervision. Across randomized controlled pilot (N=28; N=36) and~     efficacy trials (N=128), STAND demonstrates medium to large effects on ADHD and ODD symptoms~     and indices of academic and family impairment. In the proposed study, 240 adolescents with~     ADHD who present for treatment at one of four community mental health agencies in Miami-Dade~     County, FL will be randomly assigned to STAND or agency usual care (UC). Participating agency~     therapists also will be randomly assigned to deliver STAND or UC. STAND therapists will~     receive a comprehensive treatment manual, three-day training, and weekly supervision from a~     project psychologist. Participants will be screened by research staff in the community~     setting and enrolled on a rolling basis over 30 months. Participants will be assessed at~     baseline, post-treatment, and three-month follow-up. In line with RDoC, multi-method measures~     will be obtained for treatment outcome (family and academic impairment), treatment mediators~     (executive functioning, parent academic involvement, parent-teen communication,~     parent/adolescent motivation, ADHD symptoms), and moderators of effectiveness (patient,~     practitioner, service delivery, and organization characteristics). Additional consumer~     perspective (satisfaction, therapeutic alliance) and agency fit (therapist competence,~     treatment fidelity, need for additional treatment, attendance, therapist attitude toward~     treatment, cost effectiveness) measures will also be obtained to evaluate effectiveness. We~     will recruit an ethnically diverse sample (65% Hispanic, 19% African-American, 16%~     Non-Hispanic White) that is historically underrepresented in research, but ideal for~     evaluating therapy effectiveness.~   "
66622|NCT02694926|"~     Even under established replacement therapy, patients with adrenal insufficiency still suffer~     from impaired quality of life and experience adrenal crises. Patient education is regarded as~     important preventive measure. In this study a german-wide standardized education Programme~     will be evaluated.~   "
66654|NCT02694497|"~     Multicenter prospective cohort study in Chlamydia trachomatis positive women after regular~     treatment to understand the transmission of anorectal CT infections.~   "
66626|NCT02694874|"~     Even with optimal anti-malaria therapy and supportive care, severe and cerebral malaria are~     associated with a 10-30% mortality rate and neurocognitive deficits in up to 33% of~     survivors. Adjunctive therapies that modify host immune-pathological processes may further~     improve outcome over that possible with anti-malarials alone. Investigators aim to evaluate a~     PPARγ agonist ( rosiglitazone) as adjunctive therapy for severe malaria.~   "
66627|NCT02694861|"~     The purpose of this study it to collect real world 30-day and 1-year follow-up data for~     patients undergoing TMR with the CardioGenesis Holmium:YAG Laser System either as a sole~     therapy procedure or in conjunction with coronary artery bypass graft (CABG) surgery.~      The primary objective of this study is to provide ongoing clinical data regarding the~     characteristics of the patient population undergoing TMR in community practices. Secondary~     objectives include rates of postoperative mortality and MACE at 30-days and 1-year, and~     benefit of sustained improvement in angina at 30-days and 1-year.~      The study includes two patient populations:~        -  Registry Group: Patients from selected centers who previously participated in the ANGINA~          RELIEF Registry and are eligible for a one-year, prospective follow-up;~        -  Prospective Group: Up to 100 new, prospectively enrolled TMR patients from selected~          centers.~   "
66628|NCT02694848|"~     To evaluate the therapeutic evaluation of combination therapy with aspirin and salvianolate~     injection based on the population pharmacokinetics and TEG.A prospective, multicenter,~     randomized, controlled clinical trial is used.A total of 120 patients will be recruited and~     will be divided into three groups,respectively salvianolate injection group,aspirin group and~     salvianolate injection and aspirin group，and the course of treatment is 10 days.~   "
66629|NCT02694822|"~     This is an open-label, Phase 1, multicenter study to evaluate the safety, PK, and PD of an~     anti-CTLA-4 human monoclonal antibody (AGEN1884) and to estimate the MTD in subjects with~     advanced or refractory cancer. The study will consist of a 3+3 dose escalation cohort~     starting at a near minimally anticipated biologic effect level (MABEL) dose with expansion~     cohorts at 1 mg/kg and 3 mg/kg..~   "
66630|NCT02694809|"~     The main purpose of this study is to determine if taking the study drug, conjugated~     estrogens/bazedoxifene (Duavee®) causes any changes in the proliferation markers within the~     breast tissue of the study subjects. The study drug is approved by the US Food and Drug~     Administration in healthy postmenopausal women to treat certain symptoms of menopause such as~     hot flashes. Since it is not approved in women with DCIS, its use in this study is~     experimental. This study will also look at whether taking the study drug causes any~     significant or undesirable side effects in women with DCIS. The researchers hope that this~     study will help them determine if taking the study drug is safe in women taking DCIS and if~     it can possibly reduce the risk of developing breast cancer in women with DCIS.~   "
66631|NCT02694796|"~     The purpose of this study is to evaluate the impact of an intervention combining a workshop~     during a balneotherapy and the use after the end of the balneotherapy of a web and~     smartphone-based physical activity program using connected devices, on physical activity~     level among patients 12 months after they participated in a balneotherapy in thermal care~     center.~      A multi center randomized controlled trial is setting to evaluate the impact of the~     intervention on physical activity recommendations achievement of the patients.~      Investigators hypothesize that an intervention including a workshop during a balneotherapy~     and an automated physical activity program using web, mobile phone and connected devices will~     help patients to be engaged in more physical activities and to reach physical activity~     recommendations.~   "
66632|NCT02694783|"~     Background:~      Progressive Multifocal Leukoencephalopathy (PML) is a brain infection in people with a~     weakened immune system. Researchers think polyoma virus specific T cells (PyVST) therapy can~     treat PML. The PyVST cells are made from blood cells of a healthy relative. They are grown in~     a lab to expand the virus-killing cells, then given to the person with PML.~      Objective:~      To test whether PyVST safely treats PML.~      Eligibility:~        -  Adults ages 18 and older with PML~        -  Healthy adults ages 18 and older who have:~             -  Been screened under protocol 97-H-0041~             -  A sibling, parent, or child with PML and matching cells~      Design:~        -  Participants will be screened with:~             -  Medical history~             -  Physical exam~             -  Blood and urine tests~        -  PML participants will also be screened with:~             -  Cerebrospinal fluid removed by needle in the back.~             -  MRI: A dye is injected in a vein. They lie on a table that slides into a cylinder.~             -  Questionnaires~      Healthy participants will have apheresis: Blood flows through a needle in one arm into~     machine that separates blood cells needed for donation. The rest of the blood is returned by~     needle to the other arm. Some participants may have a central line placed in a vein instead.~     They can have apheresis up to 3 times, at least 28 days apart.~      Participants with PML will receive the PyVST cells by needle in the arm. They will stay in~     the hospital 1 week. They can do this up to 3 times, at least 28 days apart. After each~     infusion, they will have weekly visits for 1 month. Then they will have 4 visits over 1 year.~     Visits include repeats of screening tests.~   "
66633|NCT02694770|"~     This study is to assess the efficacy of Neihulizumab versus conventional therapy and to~     evaluate safety, pharmacokinetics and immunogenicity in treating steroid-refractory acute~     Graft-vs-Host Disease~   "
66634|NCT02694757|"~     The purpose of this study is to evaluate the efficacy of the Ostom-i device in decreasing~     readmission rates of subjects with new ileostomies in the first 30 days post-operatively.~   "
66635|NCT02694744|"~     The purpose of this study is to evaluate the efficacy and safety of patiromer administered~     once daily (QD) when given with food compared to without food (experimental treatment group)~     for the treatment of hyperkalemia (high potassium in the blood).~   "
66636|NCT02694731|"~     Participants will complete a 5-week smartphone app-based intervention that teaches mindful~     eating skills. One goal is to determine to what extent participants will enjoy using the app~     and complete the intervention. The investigators predict that after completing the~     intervention, participants will report fewer episodes of eating in response to food cravings.~     The investigators will also measure several other biological and behavioral outcomes.~   "
66637|NCT02694718|"~     The purpose of this study is to determine the pathological complete tumor response rate.~   "
66638|NCT02694705|"~     Comparison of the preoxygenation efficacy of tidal volume breathing using three different~     preoxygenation techniques which are available to providers in the prehospital environment.~   "
66640|NCT02694679|"~     Social network targeting strategies can be used to improve the delivery and uptake of health~     interventions. We will enroll approximately 30,000 individuals into a randomized controlled~     trial of different targeting algorithms in order to explore how social network dynamics~     affect the uptake, diffusion, and group-level normative reinforcement of key neonatal and~     infant health behaviors and attitudes in 176 rural villages in the Copan region of Honduras.~     Our goal is to develop methods by which global health practitioners can exploit face-to-face~     social network interactions in order to maximize uptake of neonatal and infant health~     interventions. The villages will be randomly assigned to 16 cells of 11 villages each in a 2~     x 8 factorial design of different targeting algorithms.~   "
66641|NCT02694666|"~     This study is to investigate the effects of controlled whole-body vibration training on~     reducing the likelihood of falls among healthy population and people with multiple sclerosis.~   "
66642|NCT02694653|"~     To evaluate the use of maternal opiates for pain control post cesarean delivery in those~     patients that received intravenous acetaminophen 1000 mg in 150 mL of normal saline, infused~     30 minutes prior to incision compared to placebo. A comparison of post delivery length of~     stay in both study groups will be evaluated for cost effectiveness of the use of~     acetaminophen. a secondary purpose is to determine the levels of neonatal acetaminophen in~     cord blood at the time of delivery, since this has never been studied.~   "
66643|NCT02694640|"~     Exercise adoption enhances well-being and recovery from breast cancer. Researchers trained~     American Cancer Society volunteers to provide exercise counseling to breast cancer survivors~     and the survivors increased their exercise in the short-term. This RCT examines the effects~     of three maintenance conditions on survivors' exercise participation at longer follow-ups.~     The cost-effectiveness of the three groups will be examined to guide implementation of this~     peer mentoring approach in community-based organizations.~   "
66644|NCT02694627|"~     This study seeks to assess the impact of the MenCare+/Bandebereho fathers'/couples' group~     education intervention on men's attitudes towards, and participation in, sexual and~     reproductive health, maternal, newborn and child health, and equitable and non-violent~     relationships with their children and partners.~   "
66645|NCT02694614|"~     The purpose of this study is to evaluate the effectiveness and feasibility of weight loss~     counselling via a smartphone-app for patients with overweight/obesity in a 1-year long pilot~     study.~      The study is organized in the following phases:~      Recruitment (-14 to -2). Participants will be informed about the study. Participants agreed~     to enter the study and signed an informed consent.~      Screening / Baseline measurement (week -2) Inclusion criteria will be checked. Anthropometric~     measurements: height, weight, waist circumference, body fat, blood pressure measurement,~     blood sampling for blood glucose; HbA1c, Insulin; Triglyceride, HDL-Cholesterol (assessment~     Part I). During the visit participants are requested to fill in a paper-pencil questionnaire:~     socioeconomic background (only at the beginning of the study), dietary and exercise habits,~     health-related quality of life, self-effectiveness (assessment part II). The participants are~     introduced to the smartphone assisted coaching.~      Introductory phase (2 weeks): Participants take pictures of their meals with the app, which~     they send to the dietitian. After the introductory phase, the patients and the dietitians~     discuss via app how the patients should change their habits and agree on goals to reduce~     their weight.~      Phase 1 (12 weeks): Intensive online counselling with the smartphone app, with the agreed~     upon goals in mind (5 days per week + one Skype call). Group counselling session with /~     without a dietitian are held if necessary. Furthermore, the dietitians make available~     information material for patient specific dietary topics online. Week 12: assessment I+II.~      Phase 2 (until week 25): The habits that further a weight reduction are being stabilised -~     the frequency of the online counselling is reduced (3 days per week), group counselling with~     / without a dietitian are held if necessary. Furthermore, the dietitians hand out information~     material for patient specific dietary topics.~      Phase 3 (week 26-52): This phase is relevant for maintaining the patient's wright. Online~     counselling happens once every 2 weeks. Group counselling with / without a dietitian are held~     if necessary. Furthermore, the dietitians hand out information material for patient specific~     dietary topics. At the end end, the dietitians will again collect data (assessment I+II). The~     online counselling process is evaluated with 3 group discussions.~      Follow-up (week 104)~   "
66646|NCT02694601|"~     The aim of the study is to evaluate the effect of a caffeine supplement on the stimulation of~     lipolysis and the production of ketones in healthy adults (N=10). Two different doses of~     caffeine (2.5 mg/kg of BW and 5 mg/kg of BW) are compared. All the participants have to~     follow three sequential visits of four hours each, which included a breakfast with one of the~     doses (2.5 or 5 mg/kg) of the caffeine supplement or without any supplement (baseline) and~     repeated blood sampling in order to evaluate ketone concentrations.~   "
66647|NCT02694588|"~     Inflammatory bowel disease (IBD) and psoriasis (Ps) are common, chronic, immune- mediated~     barrier diseases with shared inflammatory pathways. Current therapeutic interventions with~     anti-cytokine antibodies (TNF-α, IL-23/IL-12) reflect the intent to disrupt specific pathways~     of inflammatory immunopathology. Individual responses to biological treatment can be thereby~     be exploited in a systems biology approach that employs a targeted mechanism of action (MOA)~     to decipher molecular signatures of therapeutic responses in the context of a distinct~     disease entity. Using a translational approach to investigate clinical and molecular~     phenotypes during therapeutic interference with cytokine signaling and leukocyte trafficking,~     the investigators aim to trace common and unique signatures of drug- and therapy-specific~     responses.~      Patients will undergo endoscopic evaluation of the mucosal surface and gastrointestinal wall~     by conventional HD-colonoscopy, endoscopic ultrasound and confocal laser endomicroscopy prior~     to and during specific therapies with biologicals. In parallel, mucosa samples will be~     obtained to define molecular phenotypes during the course of therapy.~   "
66648|NCT02694575|"~     This is a cross-sectional observational study aiming to examine and compare the impact of~     incretin based therapies i.e. dipeptidyl peptidase-4 (DPP4) inhibitors and glucagon-like~     peptide-1 (GLP-1) analogues, on endothelial progenitor cells (EPCs) and its mobilising~     factor, stromal derived factor-1 α (SDF-1 α), in patients with type 2 diabetes mellitus~     (T2DM) who are well established on those treatments. EPCs provide vascular protection by~     means of endothelial repair and neogenesis. This endothelial protective effect may~     potentially benefit patients affected by micro or macrovascular complications arising from~     vascular injury e.g. cardiovascular disease in T2DM. The study is of particular interest as a~     small study has shown an increase in level of circulating EPC in patients treated with DPP-4~     inhibitors, thought to be mediated via the up regulation of its mobilising factor SDF-1 α.~   "
66649|NCT02694562|"~     The purpose of this study is to determine safety and local tumor control of Embozene TANDEM~     Microspheres (40um TANDEM) loaded with Irinotecan to treat metastatic colorectal carcinoma~     (mCRC).~   "
66650|NCT02694549|"~     The purpose of this study is to assess the performance and safety of the CaveoVasc® System~     for femoral vascular access and for prevention of bleeding from the femoral artery puncture~     site.~   "
66651|NCT02694536|"~     This open-label, single-arm, multicenter trial is designed to evaluate the safety of~     erlotinib in combination with standard of care chemotherapy (gemcitabine) in participants~     with locally advanced, unresectable, or metastatic pancreatic cancer.~   "
66655|NCT02694484|"~     Fecal microbiota transplantation (FMT) is recommended in the treatment of recurrent~     Clostridium difficile infection (CDI). The principle is to administer a fecal suspension of a~     healthy subject (donor) in the digestive tract of a patient with an CDI (receiver). Donors~     are being clinical and laboratory screening to reduce the likelihood of pathogens~     transmission (infectious and other). Cytomegalovirus (CMV) is part of the examinations~     requested by the Agence national de sécurité du médicament et des produits de santé in the~     context of clinical research. A sero-matching between donor and recipient CMV is requested.~     This recommendation eliminates many potential donors to a recipient. To date, the frequency~     detection level of CMV in stool in healthy volunteers with documented positive CMV serology~     is not known. In addition, CMV transmission risk via the stool is not established. This study~     aims to determine the detection frequency of CMV in healthy volunteers stool samples selected~     as potential donors for a FMT and having a positive CMV serology documented~   "
66656|NCT02694471|"~     This investigation aimed to compare the response of older adult and young men to 14 day~     bed-rest and subsequent 28 day rehabilitation. Sixteen older (OM: 55-65 years) and seven~     young men (YM: 18-30 years) were exposed to 14-day bed rest (BR) followed by 14-day~     rehabilitation (R), and 400-day of R. Quadriceps muscle volume, force and explosive power of~     leg extensors, single fiber isometric force, peak aerobic power, gait stride length, and~     several metabolic were measured before and after BR and after R.~   "
66657|NCT02694458|"~     Vancomycin is the standard first-line treatment for MRSA infections and a first-line empiric~     therapy. The relationship between exposure to vancomycin and efficacy is admitted but because~     of an important intersubject variability, therapeutic exposure isn't usually achieved.~      The primary aim of this randomized controlled trial is to evaluate a new early dosage~     adjustment strategy of vancomycin in children, comparing it to the usual treatment strategy.~      Using a bayesian approach, the purpose is to achieve earlier a therapeutic and non-toxic~     exposure to vancomycin.~      The primary hypothesis is that an early dosage adjustment strategy using a bayesian approach~     will allow patients to achieve the vancomycin pharmacological target faster than with the~     usual treatment strategy.~   "
66658|NCT02694445|"~     The purpose of the study is to estimate the Chinese economic burden in patients with~     Alzheimer's Disease (AD).~   "
66659|NCT02694432|"~     This pilot study will evaluate the feasibility of adding an online mind-body-behavior program~     to an existing behavioral self-management support platform that has been modified to promote~     achievement of blood pressure goals.~   "
66660|NCT02694419|"~     The effect of Polycystic Ovary Syndrome (PCOS) with or without obesity has received a few~     attentions. There is a lack of evidence to whether the BMI affects the endometrial blood~     flow, which is necessary for implantation.~   "
66661|NCT02694406|"~     As ovarian cancer is characterized by an anarchic neovascularization resulting in a wide~     number of immature microvessels. These vessels are characterized by a lack of coverage by~     pericytes and the higher expression of one of the receptors of Vascular Endothelial Growth~     Factor on both endothelial and epithelial cells of ovarian cystadenocarcinomas. These physio~     pathogenic characteristics have been demonstrated to be in line with variations of MR~     perfusion parameters.~      Unlike many lesions that occur in other parts of the body, biopsy should not be performed in~     adnexal masses that demonstrate no evidence of peritoneal disease because it may cause~     spillage of cystic contents, potentially leading to iatrogenic up-staging of what may have~     been a malignant tumor that was limited.~   "
66662|NCT02694393|"~     This study will assess the safety of inhaled sodium nitrite in adults with Cystic Fibrosis~     and chronic Pseudomonas infections, and determine the ability of sodium nitrite to reduce the~     burden of Pseudomonas.~   "
66663|NCT02694380|"~     The goal of this study is to measure the effect of radiation therapy on the activity levels~     of patients. This will be achieved by tracking their activity levels during a treatment~     course of radiation therapy.~   "
66664|NCT02694367|"~     The present study is based on hypotheses that some as yet unknown genetic factors may result~     in recurrent miscarriage (RM). Consequently, the main aim of this study was to gain new~     information about the underlying genetic causes of RM in the Egyptian population and to~     investigate the expression of ERK and p-ERK protein in human placenta and their corresponding~     tissue, to assess the significance of MAPK signal pathway in progression of recurrent~     miscarriage and PI3K-Akt Pathway.~   "
66665|NCT02694354|"~     To investigate safety, tolerability, pharmacokinetics and pharmacodynamics following single~     rising oral doses of BI 685509~   "
66666|NCT02694341|"~     The Bakri intrauterine balloon can achieve haemostasis in cases of postpartum haemorrhage,~     including haemorrhage associated with placenta previa by compressing the lower uterine~     segment.~   "
66667|NCT02694328|"~     This study will evaluate weight gain of ALKS 3831 compared to olanzapine in adult subjects~     with schizophrenia.~   "
66668|NCT02694315|"~     Comparison between Sonographic Cervical Length and Bishop Score in Preinduction Cervical~     Assessment prior to induction of labor as regards induction success.~   "
66669|NCT02694302|"~     A clinical trial of robot-assisted-gait-training (RAGT) in stroke patients to evaluate its~     efficacy, safety over conventional gait training.~   "
66670|NCT02694289|"~     Hypothesis: In patients, who have diabetes type 2, are treated with metformin, and are~     admitted for HF, leads to reduced insulin requirements, as measured in units of insulin, with~     no negative impact on patient safety.~      This is a single center, prospective trial. Subjects will be randomized to initiate metformin~     (starting dose 500mg orally once daily up to a maximum dose of 2,500mg daily) OR be placed on~     insulin products for management of their type 2 diabetes mellitus.~   "
66671|NCT02694276|"~     The aim is to evaluate if internet- delivered CBT, based on behavioral activation and~     exposure principles, improves wellbeing and QoL in symptomatic AF patients.The study will~     include 30 patients with symptomatic AF despite optimal medical treatment in accordance with~     current guidelines.~   "
66685|NCT02694094|"~     This research is being done to evaluate the short term and long term effects of ketogenic~     diets on measures of cardiovascular health. Such measures include cholesterol levels, blood~     pressure, weight, and thickening of the blood vessel wall over time. Adults aged 18 or older~     who are already on a ketogenic diet for at least 12 months or who are interested in beginning~     on the modified Atkins diet may join.~   "
66672|NCT02694263|"~     This study aims to determine if the addition of Canagliflozin (Invokana™) therapy to~     monotherapy of metformin is more effective at achieving the double composite endpoint of a~     reduction in HbA1c (≥ 0.3%) and weight loss (≥1kg) 3-4 weeks post-Ramadan. The study will~     also include patients currently on dual therapy, specifically metformin plus a sulphonylurea,~     pioglitazone or repaglinide to determine whether switching to metformin plus Canagliflozin~     (Invokana™) is more effective at achieving the composite endpoint compared to those remaining~     on previous dual therapy. There are a number of secondary outcomes including weight loss,~     rates of hypoglycaemia, blood pressure and a number of biochemical endpoints.~   "
66673|NCT02694250|"~     This study is being conducted to assess the radiographic (x-rays and CT scans) and clinical~     outcomes for the use of DTRAX Cervical Cage with DTRAX Bone Screw for the treatment of~     degenerative disc disease at one disc level with accompanying radicular symptoms in the~     cervical (neck) spine.~   "
66674|NCT02694237|"~     The aim of the study is determine which method of informed consent improves comprehension in~     college educated patients in a private practice setting.~   "
66675|NCT02694224|"~     To evaluate safety and efficacy of vismodegib with standard neoadjuvant chemotherapy in~     breast cancer patients based on the CTCAE v4 2010~        1. To study changes in biomarkers involved in the Hedgehog (HH) pathway in the first biopsy~          as compared to the later one~        2. To detect predictive factors among patients who reached pathological complete response~          (pCR) as compared to those with no pCR~        3. To evaluate the role of the addition of vismodegib in the pCR rate~        4. To evaluate clinical responses by breast MRI and rates of breast conservative surgery~          after neoadjuvant chemotherapy~        5. To evaluate QOL with EORTC QLQ-C30 scale~   "
66676|NCT02694211|"~     The Stress prevention at work (SPA) project intends to evaluate the method named Productivity~     Measurement and Enhancement System (ProMES) as a stress preventive approach among health care~     employees.~   "
66677|NCT02694198|"~     Fetal Fibronectin as a Predictor of Successful Induction of Mid-trimester abortion.~   "
66678|NCT02694185|"~     Ischemic heart disease (IHD) and its treatment carry profound public health and economic~     implications. Among Veterans, IHD represents one of the most common causes of death and~     disability, with over 500,000 affected individuals' annually. Rheumatic disease, though far~     less common than IHD can affect multiple organ systems and requires therapies costing in~     excess of $50,000 a year. Optimal treatment of Veterans with IHD and rheumatic disease~     requires a number of medications to maintain or improve health. Not taking medications as~     prescribed, however, is common and increases the risk of subsequent adverse events (cardiac~     death and myocardial infarction [MI]).~      To improve medication adherence rates and the cardiac health of Veterans with IHD, the~     investigators propose to test a medication adherence intervention. Known as VA SEPPRMACI-ARM~     (Secondary Event Prevention using Population Risk Management After PCI and for Anti-Rheumatic~     Medications), this intervention will consist of: proactive real-time adherence monitoring of~     patients and targeting of individuals if they have not refilled their medication a given~     number of days after it was due for refill. The intervention will employ a tailored,~     escalating-intensity approach which begins with some combination of personalized short~     messaging service (SMS) text messages and interactive voice response (IVR) telephone~     technology, depending on patient preference. Patients not completing SMS and then IVR by not~     refilling their medication (or declining SMS and not completing IVR) escalate to a trained~     research interventionalist. The interventionalist will contact the patient and address~     adherence barriers based on the dimensions outlined by the World Health Organization (WHO)~     that are specific to each patient. The investigators will test the intervention on IHD~     patients who have recently undergone PCI-a cardiac procedure commonly used among IHD patients~     to improve the heart's blood flow and in patients starting anti-rheumatic medication. The~     investigators will test the intervention at four VA Cardiac Catheterization Laboratories~     (CCLs) and have 12 sites serving as usual care controls.~   "
66679|NCT02694172|"~     The main objective of the clinical trial is to investigate whether overweight type 2 diabetic~     patients have a different fecal microbiota profile compared with age, gender, BMI matched~     subjects and with lean healthy subjects before and after the consumption of fiber rich cereal~     bars.~   "
66680|NCT02694159|"~     The study goal is to improve the value of care and reduce health disparities by developing a~     targeted set of sophisticated and powerful algorithms to improve upon human clinical~     judgments. The plan is to use the test case of detecting sepsis in patients in the emergency~     department (ED) as the first step in improving the value of care and reducing health~     disparities by developing a targeted set of sophisticated and powerful algorithms to improve~     upon human clinical judgments. This work will be performed using data from the University of~     Pennsylvania Health System where a preliminary Early Warning and Response System for Sepsis~     monitors clinical parameters. The premise underlying all this work is that by improving~     decision-making, it will both reduce low-value care and health disparities.~   "
66681|NCT02694146|"~     To evaluate the efficacy and safety of platelet rich plasma (PRP) in patients with~     coxarthrosis who don´t respond to treatment with NSAIDs, compared to treatment with~     hyaluronic acid (Hylan G-F 20).~   "
66682|NCT02694133|"~     The study will invite 30 patients to join, and they will be arranged in the face to face~     group and telerehabilitation group randomly.~      In the telerehabilitation group, the investigators use the mobile device, which with the~     camera and speaker, for patients to practice the naming training at home, and assess the~     speech ability every 2-4weeks by speech therapist via telerehabilitation platform.~      Concise Chinese Aphasia Test (CCAT) and ASHA FACS conceptual framework Test will be used as~     the assessment tool for evaluation speech ability and functional ability.~      The investigators expect that patients can improve their speech ability, functional ability,~     and quality of life via telerehabilitation speech therapy.~      And the investigators can establish the standard telerehabilitation speech therapy protocol~     for aphasia therapy.~   "
66683|NCT02694120|"~     Colonoscopy has been shown to reduce the incidence and mortality of colorectal cancer,~     through the recognition and removal of pre-cancerous lesions, which in most cases evolve with~     a sequence that goes through formation of high-grade dysplasia (HGD).~      The probability of HGD increases with the increase of the lesion of the polyp itself.~     Lesions> 2 cm are present in 1% of colonoscopy screening. The resection of these lesions~     presents a greater technical difficulty and consequently a decrease in the efficiency. The~     rate of incomplete resection reported in the literature reaches 10% while that of recurrence~     / residual adenoma 16.4 / 31.7%.~      The aim of the study SCALP is to evaluate the incidence of complications, efficacy and cost~     of endoscopic resection of colic lesions> 2cm in a setting of clinical practice in an~     unselected population~   "
66684|NCT02694107|"~     The purpose of the present study was to measure the effect of proprioceptive training,~     short-term, on dynamic postural balance during pregnancy and after 8 weeks of follow-up.~      Thirty-nine pregnant women were randomized to either the intervention group(n=20) , which~     would perform proprioceptive exercise, or the control group(n=19, no intervention) .~   "
66687|NCT02694068|"~     Peritoneal Dialysis (PD) is a technique for treating kidney failure where fluid is instilled~     into the body's peritoneal cavity. Fluid and solutes travel across the peritoneal membrane,~     and the function of this membrane is critical to successful PD. Studies have shown that~     certain demographic and clinical variables explain a very small part of the variability in~     baseline function. This study will further explore the common genetic variants that determine~     the baseline peritoneal membrane function in patients starting treatment with PD and change~     in function upon treatment .~      This study will incorporate data from subjects' first ever peritoneal equilibrium test (PET),~     changes in the transfer of water across the peritoneal membrane over time, demographic~     information, and results from laboratory analysis of DNA, blood, and dialysate. The~     investigators hope that this study will provide information on the biological pathways that~     account for variability in the peritoneal membrane. This could ultimately lead to the~     development of biomarkers to identifying individuals at risk for decline in peritoneal~     membrane function over time and/or be used to identify novel therapeutic targets to preserve~     or enhance membrane function. Identifying the biological pathways will also increase the~     understanding of vascular biology, angiogenesis, and fibrosis that could be applied to other~     tissues and other diseases.~   "
66688|NCT02694055|"~     The purpose of this study is to evaluate whether the addition of Proactive Case Detection to~     Community Case Management will provide an increase in early access to health care and a~     reduction in deaths among children aged 0-59 months. Integrated Community Case Management is~     the package of community-based services for children delivered by Community Health Workers~     (CHW), including diagnosis and treatment of malaria, pneumonia, diarrheal disease and~     malnutrition. In many iCCM interventions, CHWs are stationed in their villages and available~     in a passive, reactive manner to provide care to patients who seek them out. This study seeks~     to determine whether the addition of proactive case detection by CHWs to a standard iCCM~     intervention (ProCCM), in which they conduct daily door-to-door home visits to find and care~     for patients, will improve early access to care and reduce child mortality.~      Village-clusters will be randomised to receive Integrated Community Case Management (iCCM)~     from a passive CHW or Proactive Community Case Management (ProCCM) from a CHW that conducts~     daily active case finding home visits. All villages in both study arms will receive~     additional interventions that could significantly reduce under-five mortality, including~     removal of point-of-care fees, clinical staff training at primary health centres, and~     improvement in primary health centre infrastructure.~      All women of reproductive age eligible for inclusion in the study will be surveyed at~     baseline, and again at 12, 24 and 36 months. The study hypothesis is a significant reduction~     in child mortality in both study arms, with a significantly larger reduction where there is~     proactive case detection, or ProCCM, by CHWs. A survey of all women enrolled in the~     three-year study (eligible and consenting) has 82% power to detect an absolute difference in~     under-five mortality of 0.75% (a relative difference of 25%) between the two study arms.~   "
66689|NCT02694042|"~     Crohn's disease and ulcerative colitis, known together as inflammatory bowel disease (IBD),~     are chronic inflammatory conditions of the gastrointestinal tract. Impacts of IBD such as~     frequent hospital visits, need for surgery and poor growth, can significantly impact a~     child's social and academic life. Dealing with a chronic disease forces children to rely more~     heavily on family members for coping strategies to deal with stress. However, a lot of~     families do not have the resources (emotional or financial) to provide the level of support~     needed. A self management site called Mission is Remission® has been created to help~     adolescents and their families deal with the stressors associated with their disease. The~     site provides a supportive social network that is centred around learning sessions and active~     forums discussing topics related to disease self-management and coping. This site actively~     brings together members of the healthcare team and provides support to families who might not~     be able to travel for additional appointments outside of routine care. The goal of our~     research is to understand whether the changes this social support will increase~     disease-specific knowledge, medication adherence, and health-related quality of life. We will~     also examine whether these changes may reduce some of the demands placed on the Health Care~     system (e.g., reduced number of calls and visits to gastroenterology (GI) doctors, or time~     lost from school/work). In addition, this website has been designed to be adapted in the~     future to other chronic diseases and will help bring healthcare into the digital age.~   "
66690|NCT02694029|"~     Female patients treated with radiation for left-sided breast malignancy will undergo~     alternate fractions of Active Breathing Coordinator (ABC)-assisted and VisionRT-assisted Deep~     Inspiration Breath-Hold (DIBH).~   "
66691|NCT02694016|"~     The goal is to investigate the efficacy, safety and possible neuro- and cardioprotective~     effects of remote ischemic preconditioning (RIPC) in adult cardiac patients undergoing~     isolated aortic valve replacement surgery with a biological prosthesis. Neuropsychological~     evaluation preoperatively and at 30d after surgery will establish if there are any~     differences in neuropsychological performance between groups. A large array of biochemical~     markers will be analyzed from plasma samples taken at different time points. Additionally~     skin biopsies from the lower limb will be taken before and after performing RIPC on said~     limb. During the venous cannulation phase a atrial biopsy will be taken. The biochemical~     markers from plasma and tissue samples will be used to asses brain tissue damage,~     inflammation and cardiac tissue damage between groups.~      This will be a single center prospective randomized study with two groups. A intervention~     group (RIPC) and a control group. Study size is: 40 patients in total, 20 patients per group.~   "
66692|NCT02694003|"~     More than 90% of children with neurodevelopmental disorders (NDD) experience sleep problems,~     whereas less than 25% of typically developing children experience sleep problems. Poor sleep~     can have significant consequences for children's physical and psychosocial health, as well~     their caregivers' well-being. The impact of sleep problems on daytime functioning is even~     greater in children with NDD. Although there are a range of factors that may disturb sleep in~     children with NDD, the most frequent cause of sleep disturbance is behavioural insomnia.~     There is some evidence that behavioural interventions can be effective in improving sleep in~     children with NDD. However, this has not been tested through well-designed, large-scale~     randomized controlled trials (RCTs). Moreover, there are a number of significant barriers to~     access for insomnia treatment for children; most importantly, sleep interventions are often~     only provided by specialists, limiting access to treatment services. Instead, behavioural~     insomnia is often treated with advice about sleep hygiene and with the supplement melatonin,~     which is, at best, a short-term solution. The investigators, an interdisciplinary team of~     researchers, will develop and evaluate the effectiveness of an online sleep intervention that~     will be widely accessible and sustainable and will have the potential to dramatically improve~     the health of children with NDD and their families.~   "
66693|NCT02693990|"~     This research study is studying radiation therapy as a possible treatment for meningioma or~     tumor on the lining of the brain. The study drug or intervention involved in this research~     study is Intensity Modulated Proton Therapy (IMPT)~   "
66694|NCT02693977|"~     Pediatric obstructive sleep apnea (OSA) is associated with heavy snoring and brief pauses in~     breathing during sleep. It affects at least 1-3% of the general pediatric population with~     greater prevalence among certain high risk groups such as children with obesity, Down~     syndrome, craniofacial anomalies, or neuromuscular disorders. Several studies have shown~     that, even after having adenotonsillectomy (AT), approximately 30% of children continue to~     struggle with OSA. They further found that older children (age > 7 yrs), obesity, and high~     pre-operative OSA severity were all risk factors contributing to residual OSA. Despite these~     known risk factors, the ability to predict each individual patient's risk of residual OSA~     after tonsil surgery is difficult. Determining what tool will best predict residual OSA is an~     important step towards more effective post-surgery OSA management.~      The purpose of this study is to determine whether sleep endoscopy can predict whether their~     AT will be successful as a treatment for OSA. Our hypothesis is that subjects with multiple~     areas of obstruction in addition to large tonsils will be more likely to have residual OSA~     after AT. Sleep endoscopy is a procedure performed during drug-induced sleep that involves~     passing a flexible endoscope through the subject's nose into the back of the throat to look~     for sources of obstruction while breathing spontaneously.~      This will be a prospective cohort study examining subjects between the ages of 2 and 18 who~     are having AT for treatment of obstructive sleep apnea (OSA) and are considered high risk for~     residual OSA after surgery. High risk will be defined based on the following criteria:~     obesity, Down syndrome, African American race, severe baseline OSA, and age > 7 yrs. Eligible~     subjects will be recruited from the pediatric otolaryngology clinic at the time of initial~     evaluation for AT. Subjects will undergo a sleep endoscopy under moderate sedation at the~     time of AT. All patients will be asked to complete a preoperative sleep study to confirm the~     diagnosis of OSA and a postoperative sleep study to determine the impact of AT and the~     presence of residual OSA. Secondary outcome measures will include several questionnaires~     assessing generic and OSA-specific quality of life as well as subjective measures of~     cognitive/executive functioning and daytime sleepiness.~   "
66695|NCT02693964|"~     The study is designed to evaluate the differences in bone mineral density (BMD) and Carotid~     Intima Media Thickness (CIMT) between postmenopausal women with type 1 diabetes (T1D)~     compared to postmenopausal women without diabetes.~   "
66696|NCT02693951|"~     The purpose of the study is to assess the efficiency and safety of prophylactic use of~     antibiotics in endoscopic injection of tissue adhesive in gastric varices.~   "
66697|NCT02693938|"~     This research study is designed to look at differences in responsiveness to the subcutaneous~     injection of a standardized dose of rapid-acting insulin analog and blood glucose variability~     during different phases of the menstrual cycle in females with type 1 diabetes (T1D).~   "
66698|NCT02693925|"~     The purpose of this study is to determine the prevalence of sleep-related breathing disorders~     (SRBD) in clinically stable cardiologic outpatients of a German university clinic by means of~     polygraphy.~      Furthermore, the practicability of the underlying diagnostic process in clinical application~     is assessed as well as the sensitivity and specificity of polygraphy as compared to the~     reference standard of polysomnography. Another aim is to determine the individual~     cardiovascular risk profile by pulse wave analysis and risk classification according to~     European Society of Hypertension (ESH) and European Society of Cardiology (ESC), ESH/ESC~     risk.~   "
66699|NCT02693912|"~     In this study, the investigators aim to observe the change in alveolar macrophage function~     during acute lung injury.~   "
66700|NCT02693899|"~     Despite advances in their classification and treatment, acute leukemia remain incurable~     disease for the majority of patients. It is necessary to identify new prognostic markers of~     survival and new therapeutic targets to improve prognosis. Some studies have shown that~     Fms-like tyrosine kinase 3-ligand (FLT3-L) could be interesting from this. A more recent~     study from our group testing a novel therapy in acute lymphoblastic leukemia, showed an~     increase of this marker in the blood of patients responding to treatment. The aim of our~     prospective, non-interventional study is to measure the plasma levels of FLT3-L at different~     times of the management of patients with acute lymphoblastic leukemia but also myeloid. For~     this, analyzes of the samples collected in the usual care will be conducted to study the~     relationship between the plasma concentration of FLT3-L and outcomes. If there is any link,~     the FLT3-L could serve as a predictor of treatment response.~   "
66701|NCT02693886|"~     Individualized colonoscopy withdrawal time is determined based on the different grade of~     physician experience and quality of bowel preparation.~   "
66702|NCT02693873|"~     Osteoarthritis (OA) most often affects the hip and knee joints. The first signs and symptoms~     of pain, stiffness or swelling are not uncommon in those in their thirties and forties and 10~     per cent report symptomatic knee OA by age 60 years. Education and exercise are essential for~     people with OA to help them manage their condition better. Exercise can reduce pain, improve~     mobility and enhance quality of life. However, doing the right exercises in the right way is~     important so that joints are not overly stressed.~      The purpose of this study is to evaluate an existing evidence-based program called, Good Life~     with osteoArthritis in Denmark (GLA:D). The program has been translated and adapted to the~     Canadian context and will now be implemented in a Canadian therapy setting to start to~     understand if it is effective. This is the first time this program is being tested in Canada.~      While some people have access to self-management programs for OA, these programs often~     provide only general exercise guidance and education. GLA:D integrates patient education and~     targeted, personalized exercise for people with hip and/or knee OA. Importantly, the~     exercises are taught so that individuals learn to incorporate them in their everyday~     activities. This research is the first step to understanding if people participating in this~     program have pain relief and improved function and if they are better able to manage their~     hip or knee OA symptoms. Additionally, this initial evaluation of the program will help~     create a better understanding of the challenges in delivering the program. This will be~     valuable information for offering future programs assuming success of this pilot study.~      It is anticipated that about 60 people (30 hip OA and 30 knee OA) will participate in this~     study. These people will be recruited from the Sunnybrook Holland Orthopaedic and Arthritic~     Centre in Toronto, Ontario, Canada. All consenting participants will receive the GLA:D Canada~     program delivered by Sunnybrook's therapists.~   "
66703|NCT02693860|"~     10 patients will be enrolled in the initial cohort and will receive two infusions of~     unlabeled huJ591 on days 1 and 14. 89Zr-J591 will be administered on day 21 (+ 1 day) and a~     positron emission tomography-computed tomography (PET/CT) will be performed week later on day~     28 + 1 (visit 4). Approximately 2 to 3 weeks after the 2nd dose of J591, the patient will~     undergo radical prostatectomy with or without lymph node dissection (day 31 + 4 days). The~     final visit for the study will include a postoperative visit two weeks following surgery.~   "
66704|NCT02693847|"~     Prospective multicenter cohort recruiting consecutive patients from 7 hospitals in Andalusia,~     southern Spain, according to following criteria: 1) HIV infection, 2) Chronic active HCV~     infection, 3) Older than 18 years, 4) New diagnosis of liver cirrhosis on the basis of a~     liver stiffness above 14 kiloPascals, 5) No previous or concomitant decompensation of liver~     disease. Patients are prospectively followed-up according to a uniform protocol of care.~     Epidemiological, clinical and laboratory variables are periodically recorded. The primary~     outcomes are the emergence of a liver decompensation (including hepatocellular carcinoma),~     liver transplant or death. The predictors of these outcomes are analyzed.~   "
66746|NCT02693301|"~     This study aims to analyze the effects of an exercise program in the pulmonary function,~     cardiorespiratory fitness, diet quality index, physical activity, body composition, muscle~     function, agility, and psychological health in a group of children with asthma and~     respiratory symptoms.~   "
66705|NCT02693834|"~     PURPOSE: The purpose of this study will be to identify whether patients in the subacute stage~     of stroke, who demonstrate foot drop, will have better gait outcomes when using a Double~     Adjustable AFO, or a Posterior Leaf Spring AFO. A secondary purpose will be to determine~     whether one week of practice significantly changes gait outcomes with either of the AFO~     conditions.~      INCLUSION CRITERIA: Twenty participants over the age of 18, of any gender and ethnicity,~     diagnosed with first time unilateral stroke, 4 - 20 weeks post-stroke onset, resulting in~     hemiparesis with foot drop will be recruited for this study.~      EXCLUSION CRITERIA:~        1. Not able to receive a double adjustable AFO through their insurance~        2. Unable to follow two steps commands~        3. Unable to ambulate 20 feet with or without assistive device with a minimum level of~          assistance of contact guard assistance.~        4. Cerebellar Stroke~        5. Inability to ambulate prior to stroke~      OUTCOME MEASURES:~        1. Six Minute walk test~        2. Gait Symmetry and Gait velocity measured with GAITRite for self paced velocity walk and~          fast paced velocity walk.~      DATA COLLECTION:~      Data will be collected three times over two weeks period.~      First Visit:~      Demographics, Fugl-Meyer Lower Extremity Assessment of sensorimotor function, Mini Mental~     State Examination 6MWT and GAITRite measurements using Both types of AFO in a random order.~     Afterwards participant will be given one type of AFO (randomly selected) to practice walking~     for a week.~      Second Visit: 6MWT and GAITRite measurements using the type of AFO they were practicing with.~     Then the other type of AFO will be given to practice walking for a week.~      Third Visit: 6MWT and GAITRite measurements using the second type of AFO that they were~     practicing with the week prior. Patient will be asked which type of AFO they prefer to use.~   "
66706|NCT02693821|"~     The study's objective will be to evaluate the gabapentine efficiency in orally and long term~     used after painfully surgeries.~   "
66707|NCT02693808|"~     The purpose of this study is to determine whether injection of autologous fat or~     hyaluronic-acid injections in temporal region are effective in the treatment of temporal~     hollowing after lateral wall decompression in patients with thyroid eye disease.~   "
66708|NCT02693795|"~     Left ventricular (LV) remodeling following myocardial infarction (MI) is an established~     prognostic factor for adverse cardiovascular events and the leading cause of heart failure.~     Empirical observations suggests that Baduanjin exercise, an important component of~     traditional Chinese Qigong, exert potential impacts on cardiopulmonary function. However, the~     impact of a Baduanjin exercise-based cardiac rehabilitation program for patients recovering~     from recent MI has yet to be assessed. The aim of this trail is to evaluate whether Baduanjin~     exercise would prevent the maladaptive progression to adverse LV remodeling in patients~     following MI.~   "
66709|NCT02693782|"~     This is a placebo controlled, cross-over, randomized, double blinded study. The intervention~     food products will be taken as diet prebiotic supplements: 1. Wheat Bran Extract rich in~     arabinoxylan oligosaccharides : 15g/d (up to 10 g total additional dietary fibre per day). 2.~     Placebo product maltodextrin:equal amounts of a digestible carbohydrate.~      Primary endpoints are faecal microbiota analysis and faecal metabolite analysis~     (particularly, short chain fatty acid). Secondary endpoint is serum cholesterol, glucose, HDL~     and bowel function, gastrointestinal tolerance, quality of life and food frequency (by the~     use of questionnaires).~   "
66710|NCT02693769|"~     The purpose of this study is to investigate whether fluticasone/formoterol Breath actuated~     inhaler is effective and well tolerated in the treatment of subjects with fixed airflow~     obstruction and elevated eosinophils.~   "
66711|NCT02693756|"~     Gait stability is reduced as early as from age 40 to 50. Gait stability can be improved in~     patients with neurological diseases or in healthy elderly persons with exercises.~      There is evidence that mental practice, also called motor imagery, the imagination of~     performing a movement, can also improve an activity or balance. The effective performance and~     the imagination of a task activates some overlapping central areas and neural networks, which~     might explain the improvements after motor imagery.~      The investigators set out to test the feasibility of such a study using an open label~     randomized cross-over trial including 32 persons aged 40 years or more. The primary aim is to~     evaluate whether the instructions are clear, the intervention and the study procedures are~     acceptable and to assess the proportion of participants withdraw from the study (drop outs).~     Secondary aims are the assessment of between group differences in the changes of the gait~     stability.~   "
66712|NCT02693743|"~     Suicide was responsible for almost 40,000 deaths in 2011 in America. It is still singularly~     difficult to predict who is going to commit suicide and how to establish adequate~     interventions. Growing evidence supports the view that suicide is associated with poor~     decision making. Suicide is hypothesized to be triggered by stressful situations that create~     overwhelming psychological pain in an individual who chooses to terminate his/her own life,~     disregarding all future consequences. We have previously demonstrated rewarding impulsive~     choice common to both recent suicide attempters and suicidal depressed patients (1).~     Consistent with these findings, we hypothesize that high frequency repetitive transcranial~     magnetic stimulation (rTMS) of the left prefrontal cortex will improve impulsive response~     tendencies as measured by the delay discounting procedure, and this in turn will be~     associated with a faster resolution of suicidal ideation. To these effects we will be using a~     randomized control trial of rTMS in adult inpatients at the Psychiatric Research Institute~     (PRI) hospitalized for acute suicidality. At the conclusion of these studies, we will have~     tested the value of decision making in the development of suicide ideation and behavior, as~     well as piloted the use of rTMS in the treatment of these patients.~   "
66713|NCT02693730|"~     The purpose of this research study is to improve the understanding of irritable bowel~     syndrome (IBS) and its underlying cause. The investigators will use magnetic resonance~     imaging (MRI) to observe differences in the brain between people diagnosed with IBS compared~     to healthy controls and people with ulcerative colitis, a disease group that has already been~     characterized. By doing this correlative and comparative study, the investigators hope to~     gain knowledge on IBS in order to keep the field moving in the right direction and becoming~     one step closer to discovering effective treatments.~   "
66714|NCT02693717|"~     The goal of this clinical research study is to learn if Altima (pemetrexed) can help to~     control urothelial cancer (bladder, urethra, and/or ureters) that has spread or cannot be~     controlled with surgery. The safety of this drug will also be studied. Researchers will also~     study how a gene called MTAP may affect the way the study drug works.~      This is an investigational study. Pemetrexed is FDA approved for the treatment of~     mesothelioma and non small cell lung cancer. Pemetrexed is not FDA approved for urothelial~     cancer. It is being used for research purposes only.~      Up to 25 participants will be enrolled in this study. All will take part at MD Anderson.~   "
66715|NCT02693704|"~     This study investigates the possible benefits of using binaural spatialization techniques in~     digital wireless microphone systems for hearing aids. Speech intelligibility tests, speaker~     localization tests and preference tests are performed. The results of a diotic (current~     rendering) and a binaural (suggested rendering) rendering are compared.~   "
66718|NCT02693665|"~     To test the efficacy of FACE-TC on key outcomes, the investigators propose using an~     intent-to-treat, longitudinal, prospective, multi-site, randomized controlled trial (RCT)~     design. Adolescents with cancer, aged 14 up to 20 years, and their families (N=130 dyads;~     N=260 participants) will be recruited and randomized to FACE-TC or Treatment as Usual (TAU)~     control. Participants will complete standardized questionnaires at baseline and 3, 6, 12, and~     18 months post-intervention. Our goal is to assess the extent to which FACE-TC helps~     adolescents and young adults with cancer and their families: (1) reach and maintain better~     congruence in treatment preferences over time; (2) improve their quality of life; and (3)~     document goals of care and advance directives earlier in the course of their potentially life~     limiting illness.~   "
66719|NCT02693652|"~     A single center, open labeled phase I/IIa study to evaluate safety, tolerability and efficacy~     of a therapeutic hepatitis B vaccine in oral antiviral drug-treated chronic hepatitis B virus~     carriers~   "
66720|NCT02693639|"~     The purpose of this study is to determine prediction value of PANX1 expression in infection~     post liver transplantation.~   "
66721|NCT02693626|"~     The primary objective of this proposed three-year (January 01, 2016 to December 31, 2018)~     project is to assess whether a program of widely accessed mobile phone-based text message~     interventions ('Happy Quit') will be effective at helping people in China who smoke, to quit.~     Based on the efficacy of previous studies in smoking cessation, it is hypothesized that~     'Happy Quit' will be an effective, feasible and affordable smoking cessation program in~     China.~   "
66722|NCT02693613|"~     The objective of this study is to evaluate the effect of Kremezin® on the pharmacokinetics of~     single dose of ASP1517 in healthy non-elderly adult male subjects when administered~     concomitantly or in a time separated manner.~   "
66723|NCT02693600|"~     1. Introduction:~           Investigators think that surgery with preservation of healthy joints (hemitrapeziectomy)~          in trapeziometacarpal osteoarthritis without affecting sapho-trapezo-trapezoid joints,~          is better for scaphoid stability by preventing its collapse and thus preserving the~          stability of the carpus.~        2. Objectives and Hypothesis:~           Ligamentoplasty with partial trapeziectomy in grades II-III Eaton presents better~          results in the pollicis-lateral pinch (key pinch) strength than ligamentoplasty with~          total trapeziectomy.~           Main Objective:~           To demonstrate using the dynamometer that the postoperative key pinch strength higher~          using ligamentoplasty with partial trapeziectomy in grades II-III Eaton.~           Secondary objectives:~           To measure the collapse of the first column of thumb using calibrated radiographic~          analysis. Pain (E.V.A Scale). Range of motion (measured with goniometer). Quality of~          life (DISABILITIES OF THE ARM, SHOULDER AND HAND questionnaire).~        3. Methodology:~      It is a single-center randomized trial, parallel-group, in which two types of surgical~     techniques (TT - TP) will be compared. Patients will be randomized in this two techniques~     will be followed for one year, in routine clinical practice.~   "
66724|NCT02693587|"~     In Denmark, every 4 birth induced, most often due to prolonged pregnancy, up til 10-12 days~     after term. A group (RADS) set up by the Danish Regions has recently recommended induction~     with prostaglandins in tablet form (Angusta®). The recommendation is based primarily on the~     results of a meta-analysis published by the Cochrane Library, where various prostaglandin~     medications were compared.~      Vaginal prostaglandin insert (Misodel®) have proved safe in American Studies and is~     registered in Denmark for use of induction. Misodel® was not included in RADS's evaluation,~     as there are only few studies on the effectiveness and side effects.~      In the current study, investigators want to compare two different regimes for the induction~     of primipara who use respectively Misodel® and Angusta® as the primary method. The study is~     based on prospective collection of data from three divisions in Region Zealand, where~     investigators primarily compare the efficacy and safety but also to evaluate women's~     experience, the cost of medicine and consumption of resources in the maternity wards.~   "
66725|NCT02693574|"~     Comparison Efficacy of 14-day Triple Therapy between Clarithromycin and levofloxacin on the~     Eradication of Helicobacter Pylori in Syrian population~   "
66726|NCT02693561|"~     Smoking is an important public health issue. The self help books may have important~     motivational implications which associated with deep breath exercises could cease the habit.~     Goals: Verify the effectiveness of the deep breaths exercises from the self help books along~     with the two motivational interventions to quit smoking on the anxiety, depression and daily~     consumption levels. Method: The study will be both prospective and controlled. Individuals~     will be distributed randomly in 4 different groups: The first group will be doing the deep~     breath exercises, the second group will read a self help book, the third group will do both~     reading and exercises and the fourth group will be the control. Anxiety, depression,~     motivational level and the cigarettes daily consumption will be evaluated previously and~     after the 15 days intervention. Expected results: Decreasing in anxiety, depression and~     cigarette consumption plus an increase in the motivation to quit smoking.~   "
66727|NCT02693548|"~     SAFEHEART is a large, on-going registry study in molecularly defined patients with~     heterozygous FH treated in Spain.~   "
66728|NCT02693535|"~     The purpose of the study is to learn from the real world practice of prescribing targeted~     therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be~     a drug target or to predict sensitivity to a drug.~      NOTE: Due to character limits, the arms section does NOT include all TAPUR Study relevant~     biomarkers. For additional information, contact TAPUR@asco.org, or if a patient, your nearest~     participating TAPUR site (see participating centers).~   "
66729|NCT02693522|"~     The purpose of this study is to evaluate the efficacy and safety of recombinant human growth~     hormone on adult growth hormone deficiency~   "
66730|NCT02693509|"~     Get With The Guidelines-Heart Failure is designed to improve the quality of care in patients~     hospitalized with heart failure. The program aims to help ensure that eligible patients are~     initiated on guideline recommended therapies and receive appropriate counseling prior to~     hospital discharge.~   "
66731|NCT02693496|"~     Patients with lung nodules may develop a variety of potentially severe symptoms. These~     symptoms may impact a patient's quality of life and lead to difficult treatment. Through this~     research program, the investigators want to understand the pathogenesis of the changes of~     these symptoms.~   "
66732|NCT02693483|"~     Preoperative vaginal cleansing with povidone iodine and the risk of post cesarean~     endometritis.~   "
66733|NCT02693470|"~     Background: Psoriasis, a common inflammatory disease, is associated with atherosclerotic~     vascular diseases, including stroke, myocardial infarction, and impaired microcirculations,~     among which circulating microparticles play an important role. In severe psoriasis, there are~     increased endothelial- and platelet- microparticles that are reduced by TNF-α blockers in~     parallel with clinical improvement. However, whether Stelara(ustekinumab) treatment would~     decrease the level of microparticles remains unknown.~      Objective: The investigators will evaluate the level of microparticles among normal control,~     severe psoriasis before and 4 months after ustekinumab treatment.~   "
66734|NCT02693457|"~     This randomized controlled trial is designed to determine the effect of suction drain usage~     on the reduction of postoperative swelling following total knee replacement. Furthermore,~     this study will determine the relationship between postoperative swelling and quadriceps~     muscle function. This study will be performed in a cohort of patients undergoing bilateral~     total knee replacement and the suction intra-articular drain will be randomized to one of the~     two operative knees prior to surgery.~   "
66735|NCT02693444|"~     Clinical manifestations of rotator cuff tear include shoulder pain, weakness, and stiffness.~     The level of pain is often a limiting factor when assessing shoulder range of motion and~     strength pre-operatively. Pain itself has even been a cause of weakness due to muscle~     atrophy.~      The purpose of this study is to further understand the effect pain has by measuring constant~     shoulder scores in patients before and after ultrasound guided subacromial (the outer end of~     the shoulder blade) injection of lidocaine (a local anesthetic or numbing agent) compared to~     saline (salt solution), in patients indicated for arthroscopic rotator cuff repair. The~     saline and lidocaine has been approved for use by the U.S. Food and Drug Administration~     (FDA). The constant shoulder score includes your level of pain, activity level, range of~     motion and strength measures.~   "
66736|NCT02693431|"~     Currently the management of cystic fibrosis (CF) patients is mainly based on symptomatic~     treatments. The arrival of children in day hospital, every 2 to 3 months, is for many of them~     and those around them, stressful, rarely expressed, but noticeable by the care team. In line~     with the recommendations of the High Authority of Health, the multidisciplinary team of~     Resources and Skills Centre for Cystic Fibrosis (CRCM) Pediatric of Nantes University~     Hospital offers a therapeutic education program tailored to the needs of children with cystic~     fibrosis and their families . The aim is to support children and parents in the acquisition~     of self-care skills (knowledge and skills) and coping skills, such as managing stress and~     emotions . Our goal is to demonstrate that art therapy, mobilizing coping skills of the~     child, facilitates its expressive capabilities and reduces anxiety.~   "
66737|NCT02693418|"~     The objective of this study is to determine the magnitude and duration of the reduction in pH~     (acidification) following a single dose of Acidform vaginal gel containing 3, 4, or 5 g~     compared with hydroxyethylcellulose placebo gel (4 g) or no treatment. Vaginal pH will be~     measured 1 h, 6 h, 12 h, 24 h, then once daily for 7 days. In addition, the participants will~     be assessed for an exploratory endpoint to the determine effect of one dose of Acidform gel~     (3, 4 or 5 g) or placebo gel (4 g) or no treatment, on asymptomatic bacterial vaginosis (BV).~   "
66738|NCT02693405|"~     Significant advances in primary malignant brain tumors (PBT) treatment have led to~     dramatically improved survival, both in children and adults. However, survival has not come~     without a cost and aggressive treatment methods associated with significant long-term adverse~     effects, often referred to as late effects (Panigrahy & Blüml, 2009). These effects are the~     medical, physical, cognitive and psychosocial sequelae associated with cancer and its~     treatments that generally emerge two to five years after treatment ends (e.g., Landier &~     Bhatia, 2008).~      The most serious challenge survivors of brain tumors face may be cognitive dysfunction. One~     especially important cognitive domain is executive functioning, which refers to essential~     factors such as problem-solving, goal-directed behavior and the ability to maintain stable~     interpersonal relationships (Lezak et al., 2004). Despite the potential impact of executive~     impairments on behavioral regulation and quality of life, few studies were conducted with~     survivors of PBT specifically for the assessment of executive functioning. Another~     fundamental neuro-cognitive domain is social cognition, which refers to the ability to~     understand the intentions and beliefs of others (Frith & Singer, 2008). Social cognitive~     deficits are expected to impair autonomy and relationships, but scarce attention has been~     devoted to the study of social cognition in survivors of PBT and no study has attempted to~     compare socio-cognitive data and measures of health-related quality of life. It is noteworthy~     that executive function and socio-cognitive skills improve throughout childhood and~     adolescence, and improvements in these skills have frequently been attributed to maturation~     of the brain, especially the prefrontal cortex (e.g., Tamnes et al., 2010). This suggests a~     greater impact of the disease and its treatment on these functions in children/adolescents.~   "
66739|NCT02693392|"~     In the proposed study, hydroalcoholic Fenugreek seed extract will used add-on to the existing~     therapy in patients with type-2 diabetes. The efficacy and safety of the extract will be~     evaluated using standard methodology.~   "
66740|NCT02693379|"~     The purpose of this study is to determine whether smartphone photos may assist health-care~     worker (on-site) and to evaluate the diagnostic reliability and accuracy of cervical~     examination with smartphone photos of VIA (D-VIA), on-site and off-site, compared with~     conventional VIA, for human papillomavirus (HPV) positive women.~   "
66741|NCT02693366|"~     The purpose of this study is to analyze the safety, renal function, metabolic disorders and~     quality of life data in patients with focal segmental glomerulosclerosis treated with~     endovascular infusion of bone marrow derived mononuclear cells.~   "
66742|NCT02693353|"~     Prospective, observational cohort study evaluating the association between pre-surgical~     existence of an epiretinal membrane (ERM) and the development of pseudophakic cystoid macular~     edema (PCME) using spectral domain optical coherence tomography (OCT) measurements.~   "
66743|NCT02693340|"~     This is a monocentric prospective study for the collection of biological samples (blood and~     biopsies) to be used for in vitro biomarker assay(s) performed to identify predictive markers~     of response to biological treatments in inflammatory bowel disease (IBD).~   "
66744|NCT02693327|"~     This research study will examine the relationship interconnecting medical body health, mental~     health, and microbes of the digestive tract in persons living with serious mental~     illnesses,as compared to persons without such disorders. Existing research suggests that~     interactions between digestive tract microbes and the body may influence brain function~     circuits, mood, anxiety state, cognition, behavior, and medical physiology.~   "
66745|NCT02693314|"~     The purpose of this study is to determine the effects of the two doses of Jarro-Dophilus EPS®~     probiotic supplements on fecal lactobacillus and bifidobacteria numbers, transit survival of~     administered probiotic strains, fecal microbiota, gastrointestinal function and general~     wellbeing in healthy human adults.~   "
66747|NCT02693288|"~     Distal radial fracture reparations by volar plating are often managed under regional~     anaesthesia, but are associated with severe pain when the block ends. Acute post-operative~     pain may delay rehabilitation, and even be a risk factor for the development of chronic pain.~     The use of opioids and the inevitable opioid-related side effects further decrease patient~     satisfaction. A multimodal approach to pain management should include local or regional~     analgesia technique when possible. In the case of wrist fractures, two methods are available:~     peripheral nerve block by the anaesthesiologist or surgical site local infiltration by the~     surgeon with a long-acting local aesthetic. Both techniques are commonly used for the~     management of postoperative pain after diverse orthopaedic surgeries.~      The purpose of this study was to determine the equivalence between ultrasound-guided~     peripheral nerve block and local infiltration by the surgeon for short-term postoperative~     analgesia after surgical reparation of isolated closed wrist fractures by volar plating under~     regional anaesthesia. The quality of postoperative pain, patient satisfaction and adverse~     events were recorded for the first 48 hours following surgery.~   "
66748|NCT02693275|"~     This study is being conducted to create a database for the Quotient® System iPad Test. Using~     community sampling, NCS Pearson will compile the results of this study to create a database~     against which the results of clinical Quotient tests may be compared to determine patient~     performance relative to the expected results for developmental age and gender.~   "
66749|NCT02693262|"~     Dr. Jonathan Hsu and Dr. Eric Adler are conducting a research study to find out more about~     how implantable cardiac defibrillator (ICD) settings can be adjusted to improve patient~     cardiovascular health and quality of life. Patients are being asked to participate in this~     study if they have a history of heart failure and have or are scheduled to be implanted with~     a BIOTRONIK ICD that is capable of closed loop stimulation (CLS). CLS is a device setting~     that works with the cardiovascular system to optimize their heart rate during physical~     activity. This study is comparing BIOTRONIK's CLS setting to a standard accelerometer~     setting, which also is able to adjust the heart rate by movement sensors, when necessary.~     This study has been initiated by Dr. Hsu and Dr. Adler and is financially supported by~     BIOTRONIK, Inc. There will be approximately 15 participants in this trial.~   "
66750|NCT02693249|"~     The purpose of this study is to investigate the psychological consequences of motor vehicle~     accidents and burn accidents in 7-18 years old children and adolescents. The impact of~     posttraumatic cognitions on developing psychological symptoms are of particular interest.~   "
66751|NCT02693236|"~     The aim of this Phase I/II study is to evaluate the safety and efficacy of dendritic~     cells(DC) combined with cytokine-induced killer (CIK) cells in patients with advanced~     esophagus cancer. Experimental recombinant adenovirus coded mRNA including MUC1 and Survivin~     that transfected DC, which are used for DC-based immunotherapy. Based on the results of our~     previously performed preclinical study with DC vaccine combined with CIK cells, the~     researcher plan to perform the clinical trial.~   "
66752|NCT02693223|"~     Get With The Guidelines-Stroke is a program for improving the quality of care for patients~     hospitalized with stroke by promoting consistent adherence to the latest evidence-based~     clinical practice guidelines.~   "
66753|NCT02693210|"~     WA16291 is a Phase IIa proof-of-concept study. The primary objective of this study is to~     determine the safety and efficacy of rituximab (a B cell depleting chimeric monoclonal~     antibody) used either as monotherapy or in combination with methotrexate or cyclophosphamide~     in participants with rheumatoid arthritis who have failed prior Disease Modifying~     Anti-Rheumatic Drug (DMARD) therapy and currently have an inadequate clinical response to~     methotrexate.~   "
66754|NCT02693197|"~     The primary objective is to determine the single-dose pharmacokinetics (PK) of T-817 and~     T-817M5 (metabolite of T-817) in subjects with mild, moderate or severe hepatic impairment~     compared to matched healthy control subjects.~      The secondary objective is to determine the safety and tolerability of single-dose T -817MA~     (Maleate salt of T-817) in subjects with mild, moderate or severe hepatic impairment.~   "
66755|NCT02693184|"~     The purpose of this study is to validate a revised food frequency questionnaire that is~     designed to capture vitamin D, calcium and protein intake in a population of elderly men and~     women with fragility fractures. Protein, calcium and protein intake will be correlated with~     biochemical measures and bone mineral density measured by DXA.~   "
66756|NCT02693171|"~     The purpose of this study is to assess the incidence of human anti-chimeric antibody (HACA)~     in high-risk neuroblastoma patients treated with Unituxin combination therapy.~   "
66757|NCT02693158|"~     The primary objective of this multicenter, single-arm, observational study is to evaluate the~     feasibility of a systematic direct stenting strategy with the Svelte SLENDER IDS~     Sirolimus-Eluting Coronary Stent-on-a-Wire Integrated Delivery System (SLENDER IDS) in an~     all-comers, real-world population.~   "
66758|NCT02693145|"~     CoRECT will help identify the important components of a data-sharing partnership between~     health departments and HIV care providers, and determine the extent to which a health~     department intervention can increase the number of HIV-infected persons out-of-care who: (a)~     link to an HIV clinic; (b) remain in HIV medical care; (c) achieve HIV viral load suppression~     within 12 months; and (d) achieve durable HIV viral load suppression over 18 months. We will~     also measure the cost-effectiveness of this intervention in regards to improved health in the~     individuals (re)-engaged in HIV care and reductions in further HIV transmission in the~     community.~   "
66773|NCT02692950|"~     Rates of advance directive completion among Americans, even those suffering from serious~     chronic illness, are notoriously poor. Moreover, the contents of completed advance directives~     are often difficult to interpret in the face of a medical crisis. The study aims to examine~     patient perceptions of electronic, interactive versions of advance care planning~     documentation.~   "
66774|NCT02692937|"~     The purpose of this study is to compare the effects of neurolysis with the effects of a~     exercise program on pain and other symptoms in individuals with chronic whiplash (WAD~     II-III).~   "
66787|NCT02692768|"~     The purpose of this study is to determine if music therapy interventions as adjunct to~     standard surgical care reduces pre- and post-operative pain and anxiety in patients~     undergoing total shoulder arthroplasty as compared with patients who receive standard of care~     without music therapy.~   "
84953|NCT02455037|"~     Evaluation of a neck strengthening program as a potential intervention to reduce the risk of~     sport-related concussion in youth contact and collision sport athletes.~   "
66759|NCT02693132|"~     Adults who are overweight or obese are typically prescribed a calorie-restricted diet and~     physical activity to promote weight loss and improve health. The manner in which physical~     activity is prescribed and monitored may influence physical activity engagement. Within the~     context of clinical research, physical activity has been prescribed in either a supervised or~     unsupervised manner. Supervised physical activity is typically done in a health-fitness~     facility under the direct supervision of trained staff. The alternative, unsupervised~     physical activity, promotes physical activity participation in a setting that is convenient~     to the individual. Unsupervised activity can be done in any environment or at any time that~     best suits the individual. Knowing the effects of unsupervised physical activity is important~     because of the translation of this type of physical activity to non-research settings.~     Therefore, knowing the magnitude of the physiological effects of unsupervised physical~     activity compared to supervised physical activity at the same prescribed intensity and dose~     is of clinical and public health importance. This study is designed to provide insight on~     these important research questions that can inform future research and the application to~     clinical, public health, and health-fitness settings.~   "
66760|NCT02693119|"~     This is a Phase 2, prospective, randomized, double-masked, vehicle controlled, single-center~     study in approximately 12 subjects with LHON to evaluate safety, tolerability and efficacy of~     elamipretide (MTP-131) topical ophthalmic solution in this patient population. At the~     conclusion of 52 weeks of treatment, subjects will be offered the opportunity to enter an~     Open Label Extension for up to 48 additional weeks of treatment.~   "
66761|NCT02693106|"~     The aim of this study is to evaluate the capacity of different dietary supplements to~     increase ketone production in healthy adults. Each supplement (leucine, butyrate, octanoate,~     carnitine or butter fraction rich in MCT) is evaluated for a period of 4-hour during which~     multiple blood samples are taken in order to measure ketone production.~   "
66762|NCT02693093|"~     The purpose of this study is to determine the safety and efficacy of NI-03.~   "
66763|NCT02693080|"~     This pilot clinical trial studies computed tomography (CT) perfusion imaging in predicting~     treatment response in patients with non-small cell lung cancer or tumors that have spread~     from the primary site (place where it started) to the lungs (metastases) treated with~     stereotactic ablative radiation therapy. CT perfusion imaging is a special type of CT that~     uses an injected dye in order to see how blood flow through tissues, including lung tissue.~     CT perfusion imaging of the lungs may help doctors learn whether perfusion characteristics of~     lung tumors may be predictive of response to treatment and whether lung perfusion~     characteristics can be used to follow response to treatment.~   "
66764|NCT02693067|"~     This study is intended to determine the safety, tolerability and reduction of biochemical~     markers (Chromogranin A or, if deemed appropriate, 5-hydroxyindoleaceticacid) and troublesome~     symptoms (particularly diarrhea and flushing) of intralesional injection of PV-10 in subjects~     with NET metastatic to the liver that are not amenable to resection or other potentially~     curative therapy.~   "
66765|NCT02693054|"~     Characterizing safety and efficacy of Halo Laser Treatment for Various Skin Conditions.~   "
66766|NCT02693041|"~     Investigators hypothesize that~        1. intake of milk products containing probiotics are associated with a reduced risk of~          spontaneous preterm delivery.~        2. intake of milk products containing probiotics are associated with a reduced risk of~          preeclampsia.~        3. probiotics decrease the overall inflammatory state in the pregnant woman.~   "
66767|NCT02693028|"~     Investigators want to investigate if the Lactobacillus Reuteri (probiotic bacteria) given to~     pregnant women can be found in different maternal compartments and in the first stool and~     oral swab collected immediately after birth of a newborn delivered by cesarean delivery.~     Investigators also want to explore if exposure to this Lactobacillus Reuteri alters the level~     of inflammation in different compartments of the mother and the infant.~   "
66768|NCT02693015|"~     This study aims to investigate the extent to which the time to angiography impacts on~     survival in patients hospitalised with NSTEMI.~   "
66769|NCT02693002|"~     Peri-menopausal women will be randomized to hormone replacement therapy or placebo for 12~     weeks to determine if markers of systolic and diastolic function change by echocardiography~     as well as laboratory markers of heart failure, including b-type natriuretic peptide (BNP).~   "
66770|NCT02692989|"~     Trauma for hip joint is common in old people. Anesthesia in these types of old patients~     carries more risk than the adult population.~      In this study the investigators will review patient's records that underwent surgery for hip~     trauma under anesthesia, and to see if type of anesthesia affects patient's outcome and the~     rate of postoperative complications.~   "
66771|NCT02692976|"~     Prostate cancer is the only type of cancer in which conventional dendritic cells (DC)~     treatment has a beneficial effect on the overall survival. In this study investigators aim to~     show immunologic efficacy of tumor-peptide loaded natural DC in metastatic~     castration-resistant prostate cancer patients (mCRPC).~      The immunomonitoring will include:~        1. functional response and tetramer analysis of delayed-type hypersensitivity infiltrating~          lymphocytes against tumor peptides and~        2. type I interferon (IFN) gene expression in peripheral blood mononuclear cells, and~        3. proliferative, effector cytokine- and humoral responses to keyhole limpet hemocyanin, a~          immunogenic protein providing T cell help.~      The secondary objectives are the safety and feasibility of natural DC vaccinations, the~     influence on the quality of life during treatment with natural DC, and the clinical efficacy~     of treatment.~   "
66772|NCT02692963|"~     The Bacillus Calmette-Guérin (BCG) vaccine, a live attenuated Mycobacterium bovis vaccine,~     has been used to prevent tuberculosis for almost a century, and it is still the most used~     vaccine in the world. There is also circumstantial and indirect evidence that BCG vaccination~     can protect against malaria. Investigators hypothesize that BCG vaccination can offer~     protection against malaria in the Controlled Human Malaria Infection (CHMI) model.~      A total of 20 healthy male and female volunteers will participate in this randomized,~     single-blind clinical trial. Volunteers will be randomized to receive either BCG vaccination~     (BCG vaccine SSI) (group 1, n=10) or no treatment (group 2, n=10). Five weeks after~     vaccination of group 1 volunteers, all volunteers will undergo a CHMI administered by the~     bites of five P. falciparum infected Anopheles mosquitoes.~   "
66775|NCT02692924|"~     Background:~      Gravid diseases are complications in pregnancy. They include gestational diabetes and~     preeclampsia. These can cause problems with how a fetus grows. Being pregnant with twins can~     make complications more likely. Research suggests that changes in fetal soft tissue may be~     the earliest signs of growth problems. These tissue changes are in lean mass, fat mass, and~     organ size. 3D images might detect these changes earlier than 2D images. This could help~     manage gravid diseases. The NICHD Fetal Growth Studies - Singletons measured fetal growth for~     four racial groups, Caucasian, African American, Asian, and Hispanic. Fetuses of obese women~     and women with twins were also measured. 2D and 3D images were taken at various stages of~     pregnancy. Measurements were taken after birth. Researchers want to expand this study by~     measuring organ volumes and body composition by racial group and in twins.~      Objectives:~      To set standards for body composition and organ volumes by race. To understand the~     relationship between gravid diseases and changes in fetal body composition and organ volume~     over the course of pregnancy. To find out whether these are different for twins than for~     single pregnancies.~      Eligibility:~      Women who participated in the NICHD Fetal Growth Studies - Singletons and Twins.~      Design:~      The data will come from the NICHD Fetal Growth Studies - Singletons and Twins.~      Researchers will review scans taken in the previous study. They will take measurements from~     the scans.~   "
66776|NCT02692911|"~     Background:~      The gallbladder is a small organ below the liver. Gallbladder cancer is a leading cause of~     cancer death among women in Chile. Chile also has among the highest rates of gallbladder~     cancer and death in the world. Researchers in a high-risk region of Chile want to find out~     more about this type of cancer. They especially want to know how inflammation affects the way~     it develops.~      Objective:~      To better understand the causes of gallbladder diseases and factors that may be associated~     with them.~      Eligibility:~      Women ages 50 74 with gallbladder cancer who are covered by the Chilean national health~     system.~      Other people over age 21 with gallbladder disease.~      Healthy adults over age 21.~      Design:~      Participants may be screened with an ultrasound. They may be asked questions about their~     health.~      Participants will have an ultrasound of the abdomen. This can be done at the study clinic or~     in the hospital or at home. The ultrasound uses sound waves to take pictures of the~     gallbladder.~      Participants will have a physical exam.~      Participants will have their mouths looked at for tooth loss, dentures, and gum redness.~      Participants will give a blood sample or saliva sample.~      Participants will be asked for access to their medical history. They may be asked to allow~     researchers to keep any samples taken during gallbladder surgery.~      Participants will answer questions about their medical history. This will include illnesses,~     surgeries, medicine use, and family history. It will also include diet and lifestyle habits,~     such as places where they have lived and worked.~      Some participants will have 3 follow-up visits over 6 years.~   "
66777|NCT02692898|"~     Background:~      The number of people who get tumors of the brain or central nervous system (CNS) is lower~     than other cancers. But these tumors cause a higher rate of serious effects and even death.~     Researchers want to test existing samples of tissue from these tumors to learn more about~     them. This may lead to better treatment.~      Objective:~      To study stored samples of CNS tumors to learn more about the tumors and explore new ways to~     diagnose them.~      Eligibility:~      The study will use tissue samples already collected at NIH from people with brain or CNS~     tumors.~      Design:~      The participants will have given their consent in a previous study.~      Researchers will review the tissue samples and any data collected about them.~      Researchers will do lab tests and scans on the samples.~      All data will be kept secure.~   "
66778|NCT02692885|"~     Background:~      The body uses energy from calories for basic functions like breathing and digesting food.~     Over time, when a person eats more calories than they burn, they may become overweight or~     obese. Obesity is a major health concern. Researchers want to look at fat and muscle tissue~     to learn more about metabolism. That is how the body uses food and other nutrients for normal~     function and energy. This research may help to develop new treatments for obesity and related~     diseases.~      Objective:~      To learn more about the role of fat and muscle in metabolism, particularly how fat and muscle~     store and use energy.~      Eligibility:~      Adults 18 years and older who have a planned surgery at NIH in which tissue can be collected~     by the surgeon.~      Design:~      Participants will be screened by their regular NIH doctor. Then researchers will contact them~     about this study.~      Participants will not have to make extra visits to NIH for this study.~      Researchers will collect samples during the participant s surgery. These will be fat tissue~     and skeletal muscle tissue. Muscle tissue will only be taken from tissue that is going to be~     discarded. Collecting the tissue will not add any time or any extra incisions than what is~     required for the surgery.~      After surgery, blood will be drawn. Some participants will have this done in the pre-op or~     post-op room. Others will have this done during their hospital stay.~   "
66779|NCT02692872|"~     Background:~      Alpha thalassemia is a blood disorder. It is caused by genetic deletions. Part of the DNA is~     missing from a group of genes called alpha globin. Alpha thalassemias are some of the most~     common genetic deletions. We are testing for alpha thalassemia trait. Alpha thalassemia trait~     is when someone has only two out of the normal four alpha globin genes. In some people, they~     lead to no symptoms. Others have changes that lead to disease, including mild anemia.~     Researchers want to learn more about alpha thalassemia and blood vessels. This may allow them~     to develop new treatments for blood diseases such as sickle cell disease.~      Objective:~      To better understand how alpha globin deletions in healthy people affect blood vessels.~      Eligibility:~      Healthy volunteers ages 18 50 who self-report African ancestry.~      Design:~      Participants will provide a one-time saliva sample. This can be by mail, in-person at a study~     event, or at NIH.~      Participants will get a small kit to collect their saliva sample. The kit has easy~     instructions. The sample does not need to be put in the refrigerator.~      Participants will spit a small amount of saliva (less than half a teaspoon) into a collection~     tube.~      Participants will close the funnel lid tightly, and then unscrew the funnel lid from the~     tube. They will then close the tube tightly with the small cap provided and shake the tube~     for 5 seconds.~      Participants will place the tube in the provided envelope and mail it to NIH. The specimen~     will be stored and processed in the lab.~      Participants may be invited to participate in more research studies, whether or not~     researchers find that they have alpha thalassemia trait.~   "
66780|NCT02692859|"~     Haemophilus influenza type b (Hib) remains a serious global health threat associated with~     high mortality and morbidity in young children. In China, The overall impact of Hib-related~     infections and the extent of coverage of Hib conjugate vaccines are unclear.Generally,~     vaccination has been considered the most effective way to prevent infection against Hib.In~     order to evaluate safety and immunogenicity of a haemophilus influenzae type b (Hib)~     conjugate vaccine developped by Chengdu Olymvax Biopharmaceuticals Inc. a phase III clinical~     trial is planned to conduct in healthy infants and children in China.~   "
66781|NCT02692846|"~     Background:~      Williams Syndrome (WS) is a genetic disorder. People with WS have less of a protein that~     allows parts of the body to stretch than other individuals. Researchers are interested in the~     stretchiness of the skin of people with WS and how it may relate to cardiovascular problems~     some people with WS develop. They are also interested in identifying exposures such as~     medications that may change the elasticity of the skin and vessels.~      Objective:~      To learn more about the skin and blood vessels in individuals with WS and how those tissues~     change over time.~      Eligibility:~      People ages 5 70 with WS.~      People ages 1 70 with a medical condition that affects connective tissue.~      Design:~      Participants will be screened with a review of their medical records.~      Participants will have 1 visit. Participants with WS may do so at a Williams Syndrome~     Association family meeting or camp, or at NIH. Other participants will be seen at NIH.~      During the visit, participants will have height, weight, and blood pressure measured.~      Researchers will listen to the participant s chest and abdomen.~      Participants skin will be examined. It may be photographed.~      Participants will have photos of their eyes and face taken.~      Researchers will use a DermaLab Suction Cup Probe. A small suction cup will be placed on the~     arm with a sticker. It will pull lightly on the skin. This allows a computer to measure skin~     flexibility.~      Researchers will use a SphygmoCor. A probe that looks like a dull pencil will be placed on~     the wrist, neck, and groin area. A computer will measure how fast the pulse is moving and~     will estimate blood vessel flexibility.~      Participants may be invited to have these procedures repeated at a later date (2 years from~     now or more).~   "
66782|NCT02692833|"~     The purpose of this study is to investigate whether biomarkers of cell senescence and aging~     can predict the development of acute kidney injury following cardiac surgery.~   "
66783|NCT02692820|"~     Babies born preterm (before completing 37 weeks in the womb) are at increased risk of~     long-term disability and death. The investigators do not fully understand the cause(s) of~     preterm birth but it occurs more frequently when the normal, healthy bacteria (called~     Lactobacilli) in a woman's birth canal are replaced with unhealthy bacteria. Previous~     attempts to get rid of the unhealthy bacteria with antibiotics have not shown to affect the~     risk of preterm birth. The reason for this may be that what is required is the replacement of~     Lactobacilli in the birth canal. This can be done by asking women to take capsules containing~     lactobacilli once daily. To study whether oral Lactobacilli capsules compared with dummy~     capsules can reduce the risk of preterm birth, a large study involving approximately 10,000~     women would be required. But the investigators do not know whether women would agree to take~     part in and complete such a study, and this is what the investigators wish to study in the~     small, initial study described here. The results of this study will show whether probiotics~     produce the desired biological effects on vaginal bacteria, and whether it would be feasible~     to perform the larger, definitive study of their effectiveness in prevention of preterm~     birth.~   "
66784|NCT02692807|"~     The primary aim of this study is to determine the efficacy of hip arthroscopic surgery~     compared to a sham surgery (diagnostic arthroscopy only) for patients with symptomatic and~     radiological findings related to impingement (FAI) and/or labral tears using a randomized~     controlled design (HIPARTI Study: Primary aim and the main paper: primary end point: iHOT 1~     year follow-up)).~      Our main hypothesis is that surgical procedures of the hip will demonstrate greater efficacy~     than sham surgery (diagnostic hip arthroscopy only) for hip related quality of life (iHOT-33)~     after 1 year and at further (HIPARTI Study).~      The secondary aim of this study is to establish modifiable risk factors associated with pain,~     function, work participation and quality of life over 1 year in people aged 18-50 years with~     hip impingement and/or labral tears diagnosed at hip arthroscopy. (HARP Study: A separate~     paper will be published with this main aim for the HARP Study) Long-term follow-ups for~     HIPARTI Study as well as HARP Study will be performed at 2, 5 and 10 years (secondary aims~     and separate papers).~   "
66785|NCT02692794|"~     Deliberate hypotension, reverse Trendelenburg position, and hyperventilation are techniques~     utilized during functional endoscopic sinus surgery to attempt to reduce surgical bleeding.~     These methods reduce blood flow to the head and neck area and assist in reducing bleeding~     during surgery but they may predispose patients to cerebral ischemia. Large scale studies~     necessary to conduct adequate statistical analysis regarding the effect of cerebral oximetry~     on otolaryngology surgery has not been extensively studied. This study seek to address the~     question of whether cerebral oximetry in the FESS population can help evaluate major and~     minor post operative morbidity, as well as the quality of recovery from surgery. Cerebral~     oximeters are small, noninvasive stickers applied to the forehead of participants and give~     the examiners data regarding the level of oxygen saturation around the brain during the~     course of surgery. During the course of such procedures, where blood flow to the head and~     neck area is intentionally decreased to assist in reducing bleeding during surgery, the~     levels of oxygen saturation around the brain may pose as a predictor or major and minor post~     operative morbidity, as well as the quality of recovery from surgery. Outcome measures will~     include major post operative complications, such as neurological and cardiac complications,~     and minor post operative morbidity, such as length of post anesthesia care unit (PACU) length~     of stay, nausea, and vomiting. Quality of recovery will also be assessed using a survey~     conducted in the PACU and again at the first post operative visit approximately one week~     after surgery.~   "
66786|NCT02692781|"~     MOD-6031 is a long-acting reversibly PEGylated oxyntomodulin (OXM) therapeutic. The active~     moiety is a gastrointestinal neuropeptide with a sequence identical to endogenous human OXM~     and is an agonist for both glucagon-like peptide-1 (GLP1) and glucagon (GCG) receptors. The~     peptide is a natural appetite suppressant, secreted by L-cells in the digestive system~     following food intake leading to a decrease in gastric emptying, satiety after crossing the~     blood-brain barrier, and regulation of insulin and glucose levels. Thus, MOD-6031 is being~     developed as a treatment for high risk subjects (obese) to increase weight loss, reduce food~     intake and increase glycemic control.~   "
66788|NCT02692755|"~     This study aims to evaluate the hematological safety of palbociclib with letrozole and~     fulvestrant in African American women with hormone receptor positive HER2 negative advanced~     breast cancer. Hematological safety is a composite endpoint of episodes of febrile~     neutropenia and treatment discontinuation due to neutropenia according to current~     recommendations for management of neutropenia~   "
66789|NCT02692742|"~     Neutropenia is the most serious hematologic toxicity of cancer chemotherapy, often limiting~     the doses and density of chemotherapy that can be tolerated. The degree and duration of~     neutropenia determine the risk of infection. Myelo001, a small orally bioavailable molecule,~     has been shown in chemotherapy- or radiotherapy-induced myelosuppression to stimulate~     differentiation of peripheral white blood cells (WBC) and bone marrow cells of the~     leucocytic, lymphocytic, and erythrocytic lineage. The purpose of the MyeloConcept study is~     to determine the safety and effectiveness of Myelo001 in preventing or reducing~     chemotherapy-induced neutropenia and myelosuppression in patients receiving chemotherapy due~     to breast cancer.~   "
66790|NCT02692729|"~     This study aims to evaluate the efficacy and safety of transverse supraumbilical incision~     over Pfannenstiel incision in performing cesarean section for morbid obese pregnant women.~   "
66791|NCT02692716|"~     This trial is conducted globally. The aim of the trial is to investigate the cardiovascular~     safety of oral semaglutide in subjects with type 2 diabetes.~   "
66792|NCT02692703|"~     The purpose of this study is to assess the safety and efficacy of 12 weeks of treatment of~     ABT-493/ABT-530 (glecaprevir/pibrentasvir) in adults who are post primary orthotopic liver or~     renal transplant with chronic hepatitis C virus (HCV) infection.~   "
66793|NCT02692690|"~     Systemic skeletal muscle atrophy (cachexia) is a typical side effect of chronic heart~     failure.~      Patients with cachexia can benefit from transcutaneous electrical neuromuscular stimulation~     (TENS). It is applied to strengthen the musculature and improve exercise tolerance and~     quality of life.~      It is unclear if application of TENS can cause electromagnetic interference (EMI) in patients~     with Optimizer® pacemaker systems for improvement of heart failure.~      This pilot safety study enrolled 6 patients with chronic heart failure and reduced left~     ventricular ejection fraction. All patients had an Optimizer® pacemaker system implanted for~     a minimum of 6 months, no patients had any ventricular arrhythmic episode 3 months prior to~     the study, and all were in clinically stable condition and willing to participate in this~     study.~      Neuromuscular stimulation was administered via TENS in 4 different modes (HF, LF, Burst, MF)~     on the right and left musculus trapezius and on both musculi quadriceps femoris. All patients~     were tested for EMI without or with cardiac contractility modulation (CCM) delivery of the~     Optimizer®-system respectively.~   "
66794|NCT02692677|"~     The purpose of this study is to assess the absorption, metabolism, and excretion of~     JNJ-42756493 in healthy male adult participants after administration of a single oral dose of~     12 milligram (mg) of unlabeled JNJ-42756493 admixed with 14C JNJ-42756493.~   "
66795|NCT02692664|"~     In this study, patients will be observed who receive an E-liac Stent Graft for treatment of~     isolated iliac aneurysms or an E-liac Stent Graft in combination with one of the following~     AAA stent grafts: E-tegra Stent Graft, Endurant AAA Stent Graft, Zenith AAA Endovascular~     Graft, Gore Excluder AAA Endoprosthesis for treatment of aorto-iliac aneurysms.~      Objectives of this post-market registry are:~      Primary: To prevent the risk of rupture and death by the treatment of common iliac aneurysm~     with an iliac branched stent graft (E-liac, JOTEC) Secondary: Evaluation of safety and~     feasibility of the E-liac Stent Graft System used in endovascular treatment of uni- or~     bilateral aorto-iliac or iliac aneurysm.~   "
66796|NCT02692651|"~     Administration of concomitant antibiotics (CA) is a known risk factor for treatment failure~     in the treatment of CDI, as well as for recurrence of CDI. Recent data suggested that among~     patients receiving CA, fidaxomicin is superior vancomycin. While these data are encouraging,~     many clinicians remain unclear on how to apply these data to patient care. Additionally,~     patients were excluded from the trials presented to the FDA if it was expected that they~     would require ≥ 7 days of CA. Therefore, the clinical question still remains of how to apply~     these data to the real world patient who requires a long course of CA and develops CDI while~     on therapy. We therefore propose an open label, comparative and prospective study of~     fidaxomicin 200 mg twice daily vs oral vancomycin 125 mg four times daily for the treatment~     of CDI among patients who are receiving a long course of CA.~      We hypothesize that fidaxomicin will be superior to vancomycin with respect to clinical cure~     for patients with CDI.~   "
66797|NCT02692638|"~     The goal is to assess the appropriateness of the standard practice of a trial of nonoperative~     management for high grade small bowel obstruction (currently up to 72 hours based on~     available literature). The investigator will offer early laparoscopic enterolysis (within 24~     hours of admission) as the comparator group.~   "
66798|NCT02692625|"~     The purpose of this study is to evaluate the efficacy of probiotic products on~     caries-associated salivary bacterial counts (Streptococcus mutans and Lactobacillus) and its~     effect on dental plaque accumulation in a group of preschool children in Saudi Arabia.~   "
66799|NCT02692612|"~     The purpose of this project is to investigate the age-related differences in force-velocity~     muscle characteristics during isolated knee extensions variable in speed and load, during~     cyclic movements on a usual and recumbent bike variable in speed and velocity development and~     a functional test battery with healthy participants aged between 20-80 years.~   "
66800|NCT02692599|"~     The purpose of this study is to evaluate the immunogenicity and safety of a live attenuated~     mumps vaccine in healthy infants between 8 - 18 months old with a commercialized live~     attenuated mumps vaccine as the control vaccine.~   "
66801|NCT02692586|"~     Evaluate the safety and effectiveness of the FlowTriever System for use in the removal of~     emboli from the pulmonary arteries in the treatment of acute pulmonary embolism.~   "
66825|NCT02692274|"~     Diagnostic point-of-care (POC) tests are being rapidly developed and implemented in~     resource-limited settings. There has been a rapid rise of HIV and TB POC tests in South~     Africa during the last 10-15 years. The investigators sought to determine the existing~     availability, current usage and future need of POC tests among rural primary healthcare (PHC)~     clinics in South Africa's KwaZulu-Natal Province.~   "
78968|NCT02533297|"~     The aim of the current study was to develop a criterion in terms of the number of sessions~     required to achieve mastery in DCS based on the learning curve assessment in real clinical~     situation.~   "
66802|NCT02692573|"~     Investigators will compare 500 full term babies delivered by SCD randomized into two groups,~     prone or supine position. Investigators will use a Panda warmer with built in Nellcor pulse~     oximeter. Each infant will have heart rate (HR), oxygen saturation via pulse oximetry,~     respiratory rate and respiratory effort documented every 1 minute for the first 5 minutes of~     life; beyond the initial 5minutes of life, monitoring as well as infant's management will be~     done as per current Weiler hospital protocols. The intervention group will be placed in prone~     position for first five minutes immediately after birth, and then changed to supine position.~     The control group will be placed supine from birth. Investigators will check for the~     incidence and severity of RD, supplemental oxygen need and duration, positive pressure~     ventilation (PPV) need and duration or other use of respiratory support (intubation).~     Additionally, investigators will record the number of infants requiring admission to the NICU~     in each group, days of ventilatory support as well as the length of hospitalization.~   "
66803|NCT02692560|"~     The investigators are doing a study to learn how to support patients aged 60+ in taking more~     breaks from sitting and reducing total sitting time. The goal of the study is to find out if~     a sitting time reduction intervention reduces sitting time compared with a control group.~   "
66804|NCT02692547|"~     The purpose of this study is to collect data on the feasibility of the HLCL system in a camp~     setting.~   "
66805|NCT02692534|"~     In this prospective study, investigators plan to evaluate the outcome of general anesthesia~     in the context of patients with a positive cocaine urine test. Patients with a positive urine~     cocaine test who do not appear acutely toxic and have normal vital signs may not have an~     increased rate of perioperative complications during elective surgery compared to similar~     patients with negative urine cocaine screening tests. Patients who are chronic cocaine users~     may have a higher anesthetic requirement.~   "
66806|NCT02692521|"~     The purpose of this study is to discover the incentives and barriers to human milk use and~     breast-feeding in the NICU graduate. By better understanding the incentives and barriers we~     believe we can define better methods for promoting higher rates and longer duration of human~     milk use in this medically fragile population.~   "
66807|NCT02692508|"~     The investigators sought to evaluate the morphological and functional changes and prognosis~     of participants with unexplainable precordial deep T-wave inversion on ECG and with apical~     thickness less than 15mm. The conduction of this study was largely due to the increased~     clinical requirement, which reflected the increased awareness among physicians of missed~     AHCM.~   "
66808|NCT02692495|"~     This study is designed as a retrospective cohort study to evaluate the potential of~     diagnostic procedures in defining populations of patients self-reporting unexpected and~     uncontrollable episodes of body odor and/or halitosis. The cohort - generally healthy~     individuals who had underwent multiple diagnostic tests recommended by their physicians and~     had not been diagnosed with any known medical condition - expressed their interest in trying~     gastrointestinal and nutritional diagnostic tests offered by Biolab Medical Unit. Our~     retrospective analysis will determine if these tests were useful as potential screening tools~     for metabolic body odor and halitosis.~   "
66809|NCT02692482|"~     The aim of the present study is to assess whether the application of a new hydrocellular~     polyurethane foam multilayer dressing shaped for the sacral area (MSP) in addition to~     standard care reduces the rate of pressure sores (PU) and their severity especially in the~     elderly population admitted for fragility Hip Fractures.~   "
66810|NCT02692469|"~     Will a laparoscopic Single-Anastomosis Duodenal-ileal Bypass with Sleeve Gastrectomy produce~     similar or superior results when compared to a laparoscopic Duodenal Switch, as a primary~     surgical procedure for weight loss in bariatric patients over a 5 year period?~   "
66811|NCT02692456|"~     Computerized tomography-guided Celiac plexus neurolysis has become a popular technique. As,~     it has Cross-section imaging system to avoids anatomic structures injury, it has high density~     resolution that clearly display the retro-peritoneal anatomic structures ,it allow an optimal~     puncture site selection and measured the angle and depth of the needle insertion accurately~     with display the range of the neurolytic agent diffusion~   "
66812|NCT02692443|"~     Patients with hypoplastic left heart syndrome and other single right ventricle lesions who~     have undergone the Fontan procedure have a high risk of neurodevelopmental disorders that~     affect quality of life and adulthood employment. This study will leverage the ongoing~     National Heart, Lung, and Blood Institute (NHLBI)-funded Single Ventricle Reconstruction~     Study by using innovative graph measures of brain connectivity to elucidate how alterations~     of the connectome in children with critical congenital heart disease are associated with~     developmental disabilities and their associated clinical risk factors. Improved understanding~     of these interrelationships may facilitate development of targeted interventions to improve~     outcome in the soaring population of adult Fontan survivors.~   "
66813|NCT02692430|"~     The purpose of this study is to perform a multicentre registry of cirrhotic patients who had~     been submitted to an imagining technique in recent years (angio-CT scan or abdominal MRI), in~     order to collect anatomical and clinical information. The main objective will be focused on~     the study of portosystemic shunts and their relation with portal hypertension.~      Patient with liver cirrhosis submitted to an abdominal angio-CT scan or a MRI from year 2010~     to 2014 will be included in the study. The chosen imaging technique will be angio-CT~     preferably, but MRI data will also be available. Patients will be identified in every~     hospital by means of the registry of coded diagnoses and the lists of complementary tests~     performed. Clinical and radiological data of every patient will be collected. The clinical~     variables will be obtained from reviewing the patient clinical history. The radiological~     parameters will be gathered by means of the systematic review of the angio-CT or MRI.~   "
66814|NCT02692417|"~     Female sexual dysfunction, including sexual arousal disorder, has a significant clinical~     impact, affecting millions of women in the United States alone. Peripheral nerve stimulation,~     such as posterior tibial nerve stimulation (PTNS) and dorsal genital nerve stimulation (DGNS)~     can modulate neural circuits for bladder and fecal continence. The investigators hypothesize~     that periodic DGNS and PTNS will modulate autonomic neural circuits and promote improvements~     in sexual function in women with sexual arousal disorder. Subjects will be randomized to~     receive one of the stimulation approaches. Subjects will have weekly 30-minute sessions~     across twelve weeks.~   "
78969|NCT02533284|"~     Study the effect of adding Magnesium sulfate to TAP block in analgesia after laparoscopic~     cholecystectomy.~   "
66815|NCT02692404|"~     In this pilot prospective longitudinal observational study, women who are pregnant and who~     will be experiencing childbirth for the first time will be recruited at the third trimester~     and observed longitudinally for psychiatric and pain characteristics until 3 months~     postpartum. The primary outcome is postpartum depression, assessed by Edinburgh Postnatal~     Depression Scale (EPDS). Infants will also be observed for infant development characteristics~     over time. Women who choose to receive labor epidural analgesia will be observed, as well as~     women who choose to avoid labor epidural analgesia. At baseline, women will complete baseline~     surveys as well as a baseline pain sensitivity test (quantitative sensory testing, QST).~     During labor, they will complete an electronic pain diary delivered by a bedside mobile~     device. Three postpartum assessments will occur over 3 months to assess maternal depression,~     other psychosocial variables, and infant development.~   "
66816|NCT02692391|"~     This is a randomized, double-blind, placebo-controlled pilot trial seeking to evaluate the~     efficacy of rectal indomethacin in abrogating systemic inflammation and subsequently organ~     failure and mortality in patients with AP and positive SIRS score.~   "
66817|NCT02692378|"~     The purpose of the study is to investigate whether oral sodium bicarbonate supplementation to~     ensure a constant bicarbonate profile in haemodialysis patients will primarily lower~     predialysis potassium levels and secondary lead to improvements in cardiac function, muscle~     mass and dialysis related symptoms.~   "
66818|NCT02692365|"~     This is an exploratory, national, single-center, open-label study, being conducted at the~     Institute of Education and Research of the Syrian-Lebanese Hospital in collaboration with the~     Radiology Institute, the Heart Institute of the Faculty of Medicine of São Paulo, Hospital~     São Paulo UNIFESP, and the Departments of Physics and Mathematics at the University of São~     Paulo in order to detect the presence of calcium flux change, tumor perfusion and electrical~     properties of tumor tissue when exposed to RF EMF AM by Cancer-frequency specific in patients~     with advanced HCC and correlate these findings with hemodynamic changes assessed by~     non-invasive hemodynamic measurements.~      This study aims to demonstrate the presence of three mechanisms (hypothesis) that could be~     involved in the hemodynamic changes and the specific antitumor effect induced by exposure to~     RF EMF AM cancer-specific frequency. This study is not intended to study a therapeutic or~     diagnostic procedure. For this reason, will not be considered evolutionary clinical data~     during and after the intervention of the study.~   "
66819|NCT02692352|"~     The main objective of this study is to examine the effect of Goal Management Training for~     patients with executive difficulties after acquired brain injury in a randomized controlled~     trial. The effect on cognitive functioning will be examined, as will the relationship between~     treatment effects and lesion location and size. The effect of Goal Management training on~     regulating emotions, quality of life and coping will be examined. The generalizability of~     treatment effects across etiologies will be explored by comparing effects in three patient~     groups; traumatic brain injury, cerebrovascular accidents and resected brain tumors.~     Structural Magnetic Resonance Imaging (MRI) scans and measures of white matter connectivity~     will be used to establish detailed lesion descriptions. Functional MRI data will provide~     information on the neural underpinnings of treatment related change. A secondary objective is~     to expand the Goal Management Training protocol with increased focus on emotional regulation~     and adherence to homework assignment.~   "
66820|NCT02692339|"~     Multicentre, prospective, observational, open-label, single arm, post-marketing study~     intended to record Lenalidomide/Dexamethasone treatment data from patients with~     relapsed/refractory Multiple Myeloma (rrMM) treated under the settings defined by the~     standard clinical practice and approved Summary of Product Characteristics (SmPC).~   "
66821|NCT02692326|"~     The aim of our study is to compare the incidence of PNAC in newborns receiving cyclic versus~     continuous parenteral nutrition (PN) in those newborns who need prolonged PN. The secondary~     aims are to compare incidence of sepsis and catheter related sepsis, mean length of hospital~     stay, mortality, nutritional status at two years of chronological age and predisposing~     factors to the development of parenteral nutrition associated cholestasis (PNAC) between the~     two groups, and to evaluate the adverse effects of the method of cycling used.~      This was a single-center, prospective randomized not blinded study was conducted in a level 3~     neonatal intensive care unit from July 2010 to January 2015. Infants with hemodynamic~     instability until a stable situation, congenital hepatic disease, preterm infants with~     diagnosis of respiratory distress syndrome or persistent ductus arteriosus and lack of~     authorization from the parents or guardians were excluded.~   "
66822|NCT02692313|"~     Epinephrine is the principal physiologic defense against hypoglycemia in type 1 and longer~     duration type 2 DM. Despite this, it is unknown how epinephrine regulates in-vivo endothelial~     function and atherothrombotic balance in humans. The specific aim of our study will be to~     determine the dose response effects of the key ANS counterregulatory hormone epinephrine on~     endothelial function, fibrinolytic balance and pro-atherogenic inflammatory mechanisms in~     healthy humans.~   "
66823|NCT02692300|"~     This study examines the potential link between deep levels of anesthesia and delirium.~   "
66824|NCT02692287|"~     The Postpartum Haemorrhage (PPH) Butterfly is a simple, low-cost device which has been~     developed as a treatment method for PPH. It will be used to stop the bleeding through~     compression of the uterus of women having a PPH. It will be markedly easier to undertake than~     traditional bimanual compression, whilst also being significantly more acceptable to women~     themselves. Use of the PPH Butterfly will provide an alternative management option for PPH~     and in some cases should avoid the need for women to have to go to theatre for treatment.~     This research will allow the investigators to determine if they have the optimum size and~     shape of the device, that it will operate as intended when compressing the uterus, and to~     gauge its acceptability to participants and users. In phase I the investigators will recruit~     healthy volunteers i.e. women who have delivered their baby vaginally following Induction~     of labour (IOL) however these women will not be experiencing a PPH. The device is to be~     assessed purely on size, usability and acceptability not for diagnosis or as a treatment~     method. Following the delivery participants will be invited to have the PPH Butterfly~     inserted vaginally for an average of 2 minutes. It is through this that the investigators~     will assess the suitability of the device in its current design, when it is in practice. The~     clinician who operates the device will complete a Likert scale questionnaire along with some~     open questions following each administration. Participants will also answer a short~     questionnaire. .~   "
66826|NCT02692261|"~     Sinus augmentation is a predictable method when alveolar bone height is not sufficient for~     dental implant placement in posterior maxillary alveolar region..The aim of this prospective,~     randomized, controlled clinical study is comparison of hyaluronic acid originated matrix and~     equine derived xenograft with only xenograft use in sinus augmentation by micro computed~     tomography and histomorphometry.~   "
66827|NCT02692248|"~     Multicentric phase II trial to evaluate efficacy and safety of ibrutinib in combination with~     rituximab, gemcitabine, oxaliplatin and dexamethasone followed by Ibrutinib maitenance in~     patients with refractory/relapsed non-GCB DLBCL non candidates to autologous stem-cell~     transplantation (ASCT) An extensive biological study will be conducted in order to further~     characterize this population of DLBCL patients and correlate the response obtained with the~     biological profile of the tumor.~   "
66828|NCT02692235|"~     Research project objectives~      The primary aims of the current research project are:~        1. To investigate the effects of carnitine with leucine supplementation, in comparison to~          carnitine supplementation alone, on muscle strength and body composition;~        2. To use carnitine supplementation as the anti-inflammatory intervention for exploring the~          relationship between inflammation and associated with aging reduction of skeletal muscle~          mass;~        3. To explore whether nutritional supplementation and resistance training might be combined~          to produce synergistic effects in prevention of muscle loss during aging;~      Hypothesis~        1. Leucine stimulates carnitine transport into the muscle cells, which improve~          mitochondrial capacity. Modification in energetic of skeletal muscle affects the body~          composition and muscle performance;~        2. The carnitine supplementation modulates the blood cytokines concentration.~          Anti-inflammatory intervention delay the reduction of skeletal muscle mass associated~          with aging;~        3. Resistance training combined with nutritional supplementation have more beneficial~          effect than resistance training alone in prevention of muscle loss during aging;~   "
66829|NCT02692222|"~     This study test the agreement and accuracy of Pulse Pressure Variation (PPV) and Cardiac~     Output (CO) obtained by the Android application Capstesia™ against the gold standard : PPV~     and CO calculated by thermodilution.~   "
66830|NCT02692209|"~     The purpose of this pivotal reader study is to assess the comparative accuracy of Fujifilm~     FFDM plus DBT versus FFDM alone in the detection of breast cancer.~   "
66831|NCT02692196|"~     Real-time fMRI neurofeedback training induced volitional control of brain activity and~     connectivity could help individuals to gain better control over their emotions.~   "
66832|NCT02692183|"~     A cornerstone in PD and ET research is the investigation of neurophysiological changes as~     potential bio-markers that could help in tracking disease progression and response to~     therapy. Electroencephalography (EEG) could provide a non-invasive and relatively inexpensive~     tool for identification of such bio-markers. In this study the investigators will use~     high-density electroencephalographic (EEG) recordings, in order to develop a platform of~     sensitive and reliable bio-markers for disease progression and response to MR-guided Focused~     ultrasound thalamotomy (FUS-T) intervention for tremor.~   "
66833|NCT02692170|"~     A single center, randomized, double blinded phase I/IIa exploratory study to evaluate~     reactogenicity, safety, immunogenicity and dose-response of a new hepatitis B vaccine in~     human adult~   "
66834|NCT02692157|"~     Healthy adult men who abuse opioids and are physically dependent on them will be invited to~     participate in a study to examine the ability of NT-814, a neurokinin (NK) antagonist at the~     1 and 3 receptor subtypes, to alter the abuse liability of oxycodone.~   "
66835|NCT02692144|"~     This study was to test the hypothesis that an optimized savory cluster (Test-cluster) made~     through a proprietary baking process combined with slow digestible carbohydrates and fiber~     will elicit lower postprandial blood glucose and insulin responses than a Control-cluster~     made from general processing procedure and with typical ingredients commonly used in~     commercially available snacks or bars: oats, peanuts, and corn syrup. However, since the~     Test-cluster contains ~30% less available-carbohydrate (24g) than the Control (33g), the~     postprandial responses elicited by the Test-cluster was also compared with those after a~     portion of White-bread matched for available-carbohydrate content. On 3 separate days, 25~     healthy male or non-pregnant females aged 18-60 yr with BMI between 20 and 35 kg/m² with~     fasting serum glucose <7.0mmol/L (126 mg/dL) were asked to consume 1 serving (56g) of the~     Test- or Control-cluster or 47g White Bread and had blood glucose and insulin measured at~     intervals over the next 4 hr. Each serving of Test-cluster and Control-cluster contained~     similar amounts of total carbohydrates, protein, fat and energy content. Each serving of~     Test-cluster and White-bread had equivalent amount of 24g available carbohydrate.~      On each test occasion, after subjects were weighed, 2 fasting blood samples were obtained by~     finger-prick 5min apart and after the 2nd sample, the subject started to consume a test meal.~     Subjects were asked to consume the entire test meal within 10 min. At the first bite a timer~     was started and blood samples for were taken for glucose analysis at 10, 20, 30, 40, 50, 60,~     90, 120, 180 and 240 min after starting to eat. Additional blood was taken into a separate~     vial at -5, 0, 20, 40, 60, 90, 120, 180 and 240 min for insulin analysis. Blood samples were~     obtained from hands warmed with an electric heating pad for 3-5 min prior to each sample.~     During the 4hr of the test, participants remained seated quietly. After the last blood sample~     participants were offered a snack and then allowed to leave.~   "
66836|NCT02692131|"~     There is an increasing need for diagnostic modalities able to objectively quantify myocardial~     function. Quantification of regional myocardial function with ultrasound is challenging on~     its own. Visual assessment of wall motion and thickening requires extensive training [1] and~     remains highly subjective [2]. Tissue deformation imaging is a recently introduced technique~     which enables the objective assessment of regional myocardial deformation assessed by~     ultrasound based strain and strain rate using Doppler Tissue Imaging or Speckle tracking.~     There are limited number of studies comparing the myocardial deformation parameters (i.e.~     Strain and Strain rate) by 2 different echocardiographic techniques viz Doppler tissue~     imaging and Speckle tracking in the perioperative period. In this study, we plan to study the~     above said parameters in patients undergoing coronary artery bypass grafting using~     transesophageal echocardiography and correlate these parameters with cardiac output by~     thermodilution method using pulmonary artery catheter.~   "
66837|NCT02692118|"~     Sepsis is still a challenge for clinicians since the detailed pathomechanism are still~     unknown and until now early markers for sepsis are not defined yet. Immunological pathways~     and new mediators defined in animal models are not yet investigated in patients with sepsis.~     Therefore the investigators will measure new mediators in patients with septic shock.~   "
66876|NCT02691598|"~     Cytokines such as such as TNF-a, IL-1, IL-6 correlate with the severity of~     pancreatitis.Neuroendocrine pathways, such as the sympathetic nervous system or~     parasympathetic nervous system, in turn, have some impact on the immune systems, through a-2~     adrenoreceptor stimulation or the cholinergic anti-inflammatory pathway. The investigators~     aim to use Dexmedetomidine Hydrochloride to decrease the activity of sympathetic nervous~     system, thus relieve inflammation response.~   "
66838|NCT02692105|"~     This study will offer men with intermediate risk prostate cancer who are suitable for, and~     interested in, prostate brachytherapy, the opportunity to be randomized between low dose rate~     (LDR) brachytherapy using permanent implantation of radioactive seeds (the current standard~     of care in BC) and high dose rate (HDR) or temporary brachytherapy which is also available as~     a standard of care in BC but only when used as a boost in addition with external beam~     radiotherapy. In addition, men will be offered the opportunity for testing the aggressiveness~     of their cancer using Cell Cycle Progression Gene Profile.~   "
66839|NCT02692092|"~     HealthEast Care System began the first community-based joint replacement registry (HJRR) in~     the U.S. in 1991, and now has more than 30,000 total joints registered. The purpose of the~     HJRR is to maintain and improve the care of individuals undergoing joint replacement surgery~     by providing timely information to their surgeons and the broader orthopaedic community.~      As it moves into the third decade, the HJRR is proud of its role in the development of the~     national American Joint Replacement Registry (AJRR) and will remain an important contributor~     to the larger national effort in the advancement of orthopaedic science.~   "
66840|NCT02692079|"~     This study investigates the effect of titanium-prepared platelet-rich fibrin (T-PRF)~     treatment on the angiogenic biomarkers in gingival crevicular fluid (GCF) in infrabony~     defects of patients with chronic periodontitis. In each patient, the infrabony defect of one~     side of arch was designated as control group (allograft), while the infrabony defect on the~     contralateral side of same arch was designated as test group (allograft+T-PRF).~   "
66841|NCT02692066|"~     Varicella zoster virus (VZV) can lead to significant morbidity and mortality in transplant~     recipients. Current recommendations suggest a 4 week waiting period between vaccination and~     transplantation and consideration of booster immunizations if antibody response does not~     reach target levels. This four week waiting period can result in delayed transplant,~     rejection of an optimal organ, or missed opportunity to vaccinate. However, these~     recommendations are not evidence based.~      This is a prospective study to look at the immune response to varicella vaccine in children~     with chronic liver disease.~      Investigators will evaluate:~        1. the time at which VZV DNA becomes undetectable in blood and saliva by PCR after~          vaccination in children with chronic liver disease and~        2. the difference in humoral and cell mediated immune response to varicella immunization~          between children with chronic liver disease and healthy children.~   "
66842|NCT02692053|"~     Sepsis induces hemostatic disorders due to the exessive or inappropriate activation of~     inflammation, which could lead either to hypercoagulability or hypocoagulability. It is~     currently not possible to determine the hemostatic status of a given patient. This~     instability of hemostatic system is not revealed by classical tests. Thus, a better~     characterization of hemostatic status could certainly improve patient care. This study aims~     at characterizing disorders of coagulation and fibrinolysis using global tests such as~     thrombin generation test or coagulolytic test. Furthermore, the association with biological~     markers of interest (such as microparticles, neutrophil elastase or histones) will be~     evaluated.~   "
66843|NCT02692040|"~     A randomised, placebo controlled Phase I study to investigate the safety, tolerability,~     pharmacokinetics and pharmacodynamics of G3215 in adult subjects.~   "
66844|NCT02692027|"~     The CASCADE-trial is a two-armed open-label randomized controlled trial conducted in rural~     Lesotho. Participants who were tested HIV-positive during community-based HIV testing and~     counseling campaigns are randomized to the intervention or control arm. Allocation is 1:1~     with parallel assignment.~      Participants in the control arm follow the standard of care after a community-based HIV test~     result: They are referred to the nearest clinic where they will receive baseline laboratory~     testing and adherence counseling. After at least 2 clinic visits for adherence counseling~     they can start anti-retroviral therapy (ART). After ART-initiation they have to attend~     monthly follow-up at the clinic for drug refill. Individuals randomized to the intervention~     arm are proposed same day community-based ART initiation combined with less frequent~     follow-up visits. The primary outcomes are linkage to care at 3 months and viral suppression~     at 12 months after having tested HIV-positive during the community-based HIV testing and~     counseling campaigns.~   "
66845|NCT02692014|"~     Coronary drug-eluting stent (DES) has been launched in China for more than ten years.~     Although it effectively decreases the overall incidence of re-stenosis, DES cannot inhibit~     the progression of atherosclerosis plaque outside segments. It was shown that the progression~     rate of non-target atherosclerosis plaque for patients with DES implantation was 6-10%, which~     indicated that current secondary prevention for coronary heart disease (CHD) is far from the~     achievement of ideal conditions.~      Atherosclerosis has many risk factors based on current CHD guidelines, among which the level~     of low-density lipoprotein (LDL) is the most concerned one. Large clinical studies on statins~     were performed in the world during the past 20 years. It was demonstrated in these studies~     that statins were significant to both primary and secondary preventions of CHD. What's more,~     the lower of LDL level is reached, the lower incidence of clinical cardiovascular events is~     achieved. However, cardiovascular events were still not avoidable especially for the~     secondary prevention of CHD even if the level of LDL was significantly controlled under the~     recommended range of guidelines by high dosage of statins.~      It was shown in some recent studies that high loading dosage of statins may effectively~     control the progression of coronary plaque. However, multiple studies found it was hard to~     control the progression of all patients of coronary plaque due to individual difference.~      Currently China Food and Drug Administration (CFDA) has not approved the loading dosage of~     all statins because of possible high safety issues and confusions about the appropriate~     application in Chinese patients, as well as economy burden to Chinese patients with high~     treatment cost. How to evaluate individual progression risk of coronary plaque and enhance~     risk factors control and the treatment of statins for necessary population, is currently an~     issue, which should be solved in the diagnosis and treatment of CHD.~      The inhibition in the progression of atherosclerosis plaque is not absolutely dependent on~     the decrease of LDL. Large number of studies found other risk factors. For instance, diabetes~     and chronic kidney diseases may also be associated with the progression of plaque. However,~     the potential impact and control are still uncertain up to date.~      Based on these background, we design a retrospective study, Risk Factors Promoting Coronary~     Plaque Progression In China (The RIPPER Study), to solve these issues.~   "
66846|NCT02692001|"~     Childhood obesity is a major problem in Canada. Children are eating larger portions and have~     easier access to high-fat, high-sugar foods and drinks. Menu labelling is a promising tool to~     teach families about healthier choices. The investigators will study the impact of combining~     child-friendly superhero food labels, fun food names, and a traffic light system on the food~     choices of children and their parents at SickKids. The investigators will use the hospital~     inpatient food ordering system (Meal Train) and look at food orders and eating patterns~     before and after introduction of the revised Meal Train menu. Only the design format of the~     menu was changed and all menu items remained unchanged. The investigators will also survey~     the families on their thoughts about the menu. This study will help doctors and dietitians~     develop strategies to deliver nutrition education to families.~   "
66924|NCT02690961|"~     The purpose of this study is to assess safety, tolerance and pharmacokinetics of~     Multiple-dose Kukoamine B Mesilate in healthy volunteers~   "
66847|NCT02691988|"~     Rationale: Because long-term use of ICS is associated with an increased likelihood of~     side-effects such as increased risk of pneumonia and loss of bone density, it is important to~     limit prescription of ICS to patients who have a clear indication for this treatment. In~     addition, avoiding unnecessary treatment with ICS could reduce the burden that chronic~     obstructive pulmonary disease (COPD) puts on healthcare budgets. The recently updated COPD~     guideline of the Dutch college of General Practitioners (NHG) emphasizes the importance of~     optimizing medical treatment for COPD patients with only limited room for the use of inhaled~     corticosteroids.~      Objective: The objective of the study is to investigate whether discontinuation of inhaled~     corticosteroids (ICS) for patients without a clear indication for ICS according to current~     guidelines results in a reduction of ICS use without adverse health effects for the patients~     involved.~      Study design: The study is a pragmatic, clustered, parallel group, non-inferiority trial in~     Dutch general practices with a follow-up of 26 weeks per patient.~      Study population: 620 COPD patients with confirmed chronic airflow obstruction, aged ≥ 40 yrs~     who use ICS for at least the prior 6 months without a clear indication.~      Intervention (if applicable): Guided ICS withdrawal in optimised COPD management. All study~     participants (of both study arms) will receive recommendations on optimal bronchodilator~     therapy and a personalized action plan to recognize symptom deterioration in an early stage.~      Main study parameters/endpoints: Number of exacerbation-free weeks. Secondary study~     parameters: successful cessation of ICS, time to first exacerbation, number of moderate and~     severe exacerbations, health-related quality of life, health status, and pneumonias.~     Moreover, information on the process of care and costs will be collected.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: Many COPD patients use ICS without a clear indication. Long-term use of ICS is~     associated with an increased likelihood of side-effects such as increased risk of pneumonia~     and loss of bone density and should be avoided in those who do not benefit from it. However,~     there is a small subgroup of COPD patients that have reduced numbers of exacerbations because~     of their ICS use and it is impossible to identify a priori the patients who this applies too.~     Therefore, it is important that the ICS discontinuation is guided to detect potential~     deteriorations early on.~   "
66848|NCT02691975|"~     This study evaluates the tolerability, safety, pharmacokinetics and efficacy of SHR3680 in~     patients with metastatic castration-resistant prostate cancer (mCPRC). All participants will~     receive SHR3680.~   "
66849|NCT02691962|"~     This study aims to prospectively explore the use of XenMatrix™ AB Surgical Graft for ventral~     or incisional midline hernia repair in patients across all wound classes (All Comers)~     through 24 months post repair.~   "
66850|NCT02691949|"~     Past literature showed encouraging effects of mycophenolate on dryness symptoms and quality~     of life in patients with Sjogren's syndrome. Mycophenolate also has excellent~     immunomodulation effects in lupus nephritis. Currently Mycophenolate is only used in lupus~     nephritis and organ transplant. It is unknown whether low dosage of mycophenolate mofetil~     could be used to improve ocular dryness and oral dryness in patients with Sjogren's syndrome.~   "
66851|NCT02691936|"~     This is a multi-centered, randomized prospective single blinded clinical trial comparing CO2~     fractionated vaginal laser therapy and vaginal estrogen cream therapy in the treatment of~     vulvovaginal atrophy/GSM.~   "
66852|NCT02691923|"~     This clinical research will evaluate the diagnostic potential of fluorescein as visualized~     through an operating microscope relative to 1) contrast enhancement on co-registered~     preoperative MR scans, 2) intraoperative ALA-induced PpIX fluorescence and 3) gold-standard~     histology obtained from biopsy sampling during the procedure.~      Subjects will include those people with operable brain tumor with first-time presumed~     pre-surgical diagnosis of high-grade glioma or low-grade glioma.~   "
66853|NCT02691910|"~     This is a randomized open-label trial to evaluate the efficacy of chloroquine (CQ) alone~     compared to chloroquine+primaquine (CQ+PQ) in the treatment of uncomplicated malaria caused~     by Plasmodium vivax infection in a endemic area in the westernmost part of the Amazon Basin~     of Brazil. The duration of follow up for evaluating CQ efficacy as a schizonticidal drug was~     28 days. The duration of complete follow up to detect recurrent P. vivax infections by~     passive surveillance was six months. All patients in the CQ alone arm received 7 days of PQ~     treatment (3.5mg/kg total dose) starting on day 28 of the study follow-up.~   "
66854|NCT02691897|"~     The aim of this study is to assess the efficacy and safety of melatonin in control of blood~     sugar in patients with type 2 diabetes mellitus (DM).~   "
66855|NCT02691884|"~     The aim of the study is to assess the change of fetal heart rate in response to the amount of~     pressure exerted on the maternal abdomen. The amount of pressure will be quantified using an~     electronic pressure sensor (FSR 400- Round Force Sensor, Interlink).~   "
66856|NCT02691871|"~     The purpose of this study is to confirm the safety of Apatinib at a dose level up to 750 mg/d~     with standard therapy of docetaxel (60 mg/m²) in advanced lung adenocarcinoma patients~     harboring wild-type EGFR after failure of first line chemotherapy and to determine the~     recommended dose for the Phase II trial.~   "
66857|NCT02691858|"~     Intussusception is one of the most frequent causes of acute bowel and second most common~     cause of acute abdominal pain in pediatric age .95 % of cases are idiopathic, the rest are~     either due to pathological lead point or post operative. Treatment of intussusception must~     start with medical resuscitation, then radiological or operative reduction of~     intussusception.~      Our surgery team has used hydrocortisone with the medical resuscitation to improve the~     success rate of pneumatic reduction and decrease the number of reduction trials.~   "
66858|NCT02691845|"~     The investigators propose a randomized clinical trial in which 240 depressed individuals are~     assigned to one of three arms, with each successive arm having an added component that may~     serve to increase and maintain physical activity:~        1. brief advice (BA) to exercise (control condition);~        2. BA + supervised & home-based exercise (SHE) + health education (HE) contact control; and~        3. BA + SHE+ cognitive-behavioral sessions focused on increasing and maintaining exercise~          (CBEX).~      The primary aim is to assess and optimize the safety, feasibility, acceptability of each~     intervention component, as well as barriers limiting their effectiveness in order to prepare~     for a larger scale randomized clinical trial.~   "
66859|NCT02691832|"~     The Double Sensor examined in this trial was developed by Dräger Company and is a novel non-~     invasive device for assessing core body temperature. In a preliminary research investigators~     have conducted the Double Sensor was found promising for potential use of physiological heat~     stress early detection. This follow-up experiment was designed to validate the data during~     high and changing body core temperatures and to examine the Double Sensor performance while~     integrated into a helmet as in intended application.~   "
66873|NCT02691637|"~     Helicobacter pylori (H. pylori) infection has been associated with a development of atrophic~     gastritis and intestinal metaplasia. H. pylori related atrophic gastritis and intestinal~     metaplasia have been regarded as pre-malignant lesion. However, the role of H. pylori~     eradication treatment in the reversibility of atrophic gastritis and intestinal metaplasia~     has not been clearly defined. The aim of the present study was to investigate the~     relationship between H. pylori eradication and the reversibility of atrophic gastritis and~     intestinal metaplasia in Korean patients.~   "
66860|NCT02691819|"~     At the same time in the side branch stent expansion vessels were embedded and balloon~     dilatation technique in for Medina1.1.1 type, 1.0.1 type or 0.1.1 type lesions of~     interventional therapy for bifurcation lesions, the PCI preoperative and postoperative 6 h,~     24h of all patients were at least three times ECG and assay of creatine kinase isoenzyme~     (CK-MB) and cardiac troponin T (TNT data analysis); immediately after operation and nine~     months after surgery, coronary angiography, quantitative coronary angiography, evaluation of~     each main branch and side branch of the lesion degree of stenosis (determination of~     bifurcation angle, reference vessel diameter, vessel diameter, minimum) and TIMI flow grade;~     using 256 slice spiral CT scanner to scan each main branch lesion and evaluation a side~     branch stenosis (determination of bifurcation angle, reference vessel diameter, vessel~     diameter, minimum). All patients were followed up for 1 months, 6 months, and 9 months~     follow-up. Cardiovascular events included total cause of death, cardiac death, total re~     hospitalization rate, recurrent myocardial infarction or unstable angina.~   "
66861|NCT02691806|"~     Sometimes, during strenuous aerobic activity, activity ceases only when the discomfort that~     follows lack of oxygen would be intolerable. Reaching this fatigue condition can cause organ~     damage, muscular damage and / or in different tissues of the body. In this study,~     investigators aim at developing new indexes, based on hemodynamics measurements from the~     peripheral micro - circulation system, for the benefit of early detection of fatigue during~     accelerated physical activity.~   "
66862|NCT02691793|"~     This study is a single arm, pilot study of Sunitinib in patient with RET fusion positive,~     FGFR2 fusion/FGFR mutation Refractory solid tumor and/or specific sensitivity to Sunitinib by~     Avatar scan that has progressed following standard therapy or that has not responded to~     standard therapy or for which there is no standard therapy.~      To investigate the efficacy and safety of Sunitinib in patient with Refractory solid tumor.~   "
66863|NCT02691780|"~     This study is a single arm, pilot study of Sorafenib in patient with BRAF mutation Refractory~     solid tumor and specific sensitivity to Sorafenib by Avatar scan that has progressed~     following standard therapy or that has not responded to standard therapy or for which there~     is no standard therapy.~      To investigate the efficacy and safety of Sorafenib in patient with Refractory solid tumor.~   "
66864|NCT02691767|"~     This study is a single arm, pilot study of pazopanib in patient with FGFR2 amplification~     Refractory solid tumor and/or specific sensitivity to pazopanib by Avatar scan that has~     progressed following standard therapy or that has not responded to standard therapy or for~     which there is no standard therapy.~      To investigate the efficacy and safety of pazopanib in patient with Refractory solid tumor.~   "
66865|NCT02691754|"~     Paracetamol is recommended as first line treatment for pain control in osteoarthritis, but it~     is not included in list of drugs than can be prescribed in charge of National Health System~     by General Practitioners. The hypothesis is that removing this economical barrier the~     investigators can decrease the prescription of NSAID and of the Proton Pump Inhibitors (PPI),~     often given for gastric bleeding prophylaxis in NSAID chronic users. As secondary outcome,~     opioids use was also monitored to see.~      Aim of the study is to test if allowing prescription of free paracetamol decreases the~     prescription of NSAID in osteoarthritic patients.~   "
66866|NCT02691728|"~     This study is evaluating the safety and efficacy of a 12 week treatment LDV/SOF FDC in~     patients with Chronic GT1 or GT4 HCV infection and autoimmune disease~   "
66867|NCT02691715|"~     Investigator will examined the diagnostic effect of the endometrial washing by saline.~     Because this technique more less painful and easier compared to endometrial curettage.~     Participants will separate into two groups. In study groups before endometrial curettage 5 cc~     saline infused to the endometrial cavity then aspirate and put into thin prep to examined.~     After this procedure routine endometrial curettage will be done. In control group only~     endometrial curettage will be done. Pathologic results of thin prep and curettage will~     compared.~   "
66868|NCT02691702|"~     This is the first clinical trial to evaluate ascending multiple oral doses in healthy adult~     and healthy elderly subjects to characterize the safety, tolerability, pharmacokinetics (PK)~     and pharmacodynamics (PD) of PF 05251749~   "
66869|NCT02691689|"~     Pulmonary arterial hypertension (PAH) in patients with congenital heart disease (CHD) is~     associated with considerable morbidity and even mortality.~      Next to environmental risk factors, the investigators believe that there is an important role~     of genetic predisposition to develop PAH in CHD. There often is a discrepancy between the~     severity of PAH and the CHD, where it is useful to screen for PAH gene mutations. The~     investigators hypothesize that the genotype is partly responsible for the phenotypic~     variability in patients with congenital shunt lesions, where some develop PAH and others do~     not. If a genetic predisposition for PAH in CHD could be identified, then genetic screening~     could be a useful additional tool for early detection of patients at risk of pulmonary~     vascular disease and PAH development, with new opportunities for prevention or early~     treatment.~   "
66870|NCT02691676|"~     Introduction: The strategy of perioperative fluid therapy has an important impact not only on~     the circulating volume and perfusion of organs and tissues but also on the patient's internal~     environment. The study aimed at comparing the effects of perioperatively administered~     balanced crystalloid infusion solutions containing different amounts of metabolizable anions~     on homeostasis.~      Methods: In the prospective randomized study, patients were assigned to Plasmalyte (PL) and~     Ringerfundin (RF) Groups after their postoperative transfer to an intensive care unit (ICU).~     The infusion solutions were parenterally administered at 1000 mL/6 hours. Arterialized~     capillary blood was sampled at the time of transfer to the ICU (Time 0), and again at 2 hours~     and 6 hours from Time 0. The collected blood was tested for blood gas parameters using the~     Astrup method.~   "
66871|NCT02691663|"~     The purpose of this research study is to determine the effect of a bicarbonate supplement on~     kidney function and physical function.~   "
66872|NCT02691650|"~     Goal of this study is to measure serum cholinesterase activity in patients with traumatic~     and/or burns injury admitted to the emergency room by using point-of- care-test system~     (POCT). Serum cholinesterase activity, measured using POCT system, might play an important~     role in the early diagnosis and prediction of patient outcome in trauma-induced systemic~     inflammation.~   "
79694|NCT02523807|"~     Patients with tremor may have varying degrees of tremor at different times. The amplitude and~     frequency of tremor may change. The investigators observational study is intended to document~     this tremor.~   "
66877|NCT02691585|"~     Blood pressure (BP) reduced significantly after listening to Indian music among~     prehypertensives and hypertensives in all subjects who were given a musical piece composed on~     raga 'bhimpalas' (raga that normalizes BP) to be heard daily for 3 months. On retrospection~     into the methodology, the effect of a single raga (Bhimpalas) alone had been tested. Heart~     rate variability (HRV) recorded once on recruitment and followed up after 3 months failed to~     show any change. The acute effect of music on HRV while listening to raga bhimpalas, and the~     effect of all ragas listed in Gandharva veda had not been tested. Respiratory rate was not~     controlled (affects HRV) and EEG waves were not studied.~   "
66878|NCT02691572|"~     The study will compare the analgesic efficacy of transversus abdominis plane block and wound~     infiltration in parturients undergoing cesarean delivery under spinal anesthesia.~   "
66879|NCT02691559|"~     Amniotic fluid (AF) pH can be affected by the maternal and/or fetal conditions such as PPROM,~     prematurity or fetal distress. It is known that fetal urine is the major content of AF since~     20th gestational week. Besides fetal alveolar fluid (FAF), gastrointestinal tract, umbilical~     cord and fetal side of placenta are important sources for AF. Bombesin-like peptides,~     8-hydroxydeoxyguanosine in fetal urine and leukotriene E(4), lecithin, sphingomyelin,~     lamellar body in FAF are molecules acting on fetal lung maturation. Varying levels of these~     molecules relevant to the stage of lung maturation may constitute an association to AF pHTo~     detect the possible effect of AF pH on neonatal respiratory morbidities 1 milliliters of AF~     is aspirated during C-section before incision of membranes. pH value of AFs were analyzed by~     the blood gas machine (Siemens RAPIDLab®1200 Systems) of NICU. Maternal and neonatal~     demographic features and clinical outcomes, incidences of morbidities such as respiratory~     distress syndrome (RDS), transient tachypnea of the newborn (TTN) are all recorded.~   "
66880|NCT02691546|"~     The SCOPE study is an observational, multicenter, prospective cohort study aimed at~     evaluating a 2-year screening programme for CKD in a population of older patients, aged 75~     years or more, in seven European Countries, in an attempt to investigate whether and to which~     extent currently available screening methods may identify older people at risk of worsening~     kidney function.~   "
66881|NCT02691533|"~     Study population: Patients admitted or seen in OPD (Out Patient Department), Department of~     Hepatology.~      Study design- Prospective Randomized Controlled Trial. Study period-January 2016 to May 2017~     Intervention- Subjects will be randomized into 3 groups Group A subjects will receive ω3 PUFA~     (Polyunsaturated Fatty Acids) (10% Omegavan 100 ml).~      Group B- will receive ω6 PUFA (Polyunsaturated Fatty Acids) (10% Intralipid 100 ml).~      Group C -Placebo group~      Monitoring and assessment- :- The following tests will be done in these patients:-~        1. Complete clinical examination.~        2. Serum electrolytes- sodium, potassium, calcium, magnesium, phosphate levels~        3. BUN (Blood Urea Nitrogen)~        4. Serum free fatty acid levels~        5. Lipid profile.~        6. Arterial ammonia~        7. Arterial lactate~        8. Blood sugar and serum insulin levels~   "
66882|NCT02691520|"~     The purpose of this study is to assess the epidemiology of Treatment Resistant Depression~     (TRD) in the nationally insured population in Taiwan including incidence, duration of~     clinical episodes, and prevalence by age and sex.~   "
66883|NCT02691507|"~     The objective of this 1 week trial is to evaluate the efficacy of an over-the-counter (OTC)~     1% colloidal oatmeal skin protectant cream in adults and children with mild to moderate AD.~   "
66884|NCT02691494|"~     This study seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in~     combination with estradiol/norethindrone acetate for the management of heavy menstrual~     bleeding associated with uterine fibroids in premenopausal women.~   "
66885|NCT02691481|"~     Diabetes-specific nutritional formulas (DSNFs) are frequently used as part of medical~     nutrition therapy for patients with type 2 diabetes in order to improve glycemic control and~     enhance weight reduction. The mechanism through which DSNFs improve postprandial (PP) plasma~     glucose is not yet known.~      The aim of this study is to compare the effects of 2 DSNFs versus oatmeal on PP plasma~     glucose, serum insulin and serum active glucagon-like peptide-1 (GLP-1), serum free fatty~     acids (FFA) and serum triglycerides (TG).~   "
66886|NCT02691468|"~     The purpose of this study is to compare difference of displacement between Polyvinyl~     Chloride(PVC) and Silicon double-lumen endobronchial tubes(DLTs) during changing position~     from supine to lateral in thoracic surgery.~   "
66887|NCT02691455|"~     Outcomes of subjects with uncontrolled glaucoma with a single existing aqueous tube shunt~     implant undergoing a second aqueous shunt to transscleral diode laser cyclophotocoagulation.~   "
66888|NCT02691442|"~     Several reports have compared the duration of action of levobupivacaine and ropivacaine as~     local anesthetic. The most widely used method for sensory function evaluation is though means~     of a pinprick test. The investigators want to use the novel method of Quantitative Sensory~     Testing to better evaluate the anesthetic activity. This method used hot and cold sensation~     to assess small nerve fiber function. The investigators will assess the duration of action of~     different drugs when used in an inter scalene nerve block in patients scheduled for shoulder~     surgery.~   "
66889|NCT02691429|"~     Our research group tested the toxicity of different dye concentrations extracted from the~     acai fruit using a rabbit model. The dye extracted from the acai fruit in concentrations of~     10% and 25% was found to be safe for vitreoretinal surgery. This initial research represented~     the landmark research for testing this alternative vital dye in a clinical research in~     humans.~      The aim of the present clinical trial in humans will be to test the applicability of the acai~     dye in the identification of the posterior hyaloid and ILM during vitreoretinal surgery in~     humans.~   "
66890|NCT02691416|"~     The purpose of this study was to evaluate differences between propofol postconditioning and~     sevoflurane anesthesia in the intracranial aneurysm surgery about antioxidant effect.~   "
66891|NCT02691403|"~     Patients undergoing abdominal procedures often require multimodal postoperative pain~     controls. Truncal blocks such as quadratus lumborum (QL) block may be used adjunctively as a~     part of it. The investigators hypothesized that the ultrasound-guided QL block with~     transmuscular approach can provide adequate pain relief for colostomy closure as part of a~     multimodal pain control.~   "
66892|NCT02691390|"~     dTMS intervention to reduce recurrent alcohol abuse among alcohol users who are abstinent for~     at least two weeks.~   "
66893|NCT02691377|"~     The purpose of this study is to determine whether acupuncture is effective and safe in the~     treatment of Primary Sjögren Syndrome.~   "
66894|NCT02691364|"~     Adaptation of the maternal immune system to accommodate the semi-allogeneic fetus is~     necessary for pregnancy success. Dysregulation of this immune adaptation is implicated in~     reproductive disorders as infertility, recurrent miscarriage, fetal growth restriction, and~     preeclampsia. The mechanisms being responsible for fetal tolerance are not known. Several T~     cell subsets have been implicated in fetal tolerance. The effects of preeclampsia on memory~     cells are not known. The main objective of this study is to analyze the effect of~     preeclampsia on levels of immune cells.~   "
66895|NCT02691351|"~     The better understanding of non-Hodgkin T-cell lymphoma is essential for establishing~     effective treatment strategy for non-Hodgkin T-cell lymphoma. Therefore, the data about~     conical features and treatment outcomes of each subtype should be accumulated to establish~     treatment strategy. However, the majority of previous data for non-Hodgkin T-cell lymphoma~     was from small case series of single institute. Furthermore, as novel drugs were developed~     for the treatment of relapsed or refractory T-cell lymphoma, the date from patients who were~     treated with those novel drugs are especially required because their outcomes may reflect the~     outcomes of currently available treatments. Thus, a multinational, multicenter prospective~     registry study is needed to provide information useful for establishing treatment strategies~     for T-cell lymphoma.~   "
66896|NCT02691338|"~     The incidence of perioperative stroke in the non-cardiac, non-vascular, non-neurological high~     risk surgical population is 2%. It is higher (~5%) for cardiac surgery and carotid~     endarterectomy patients, with a stroke associated mortality of up to 60%. These patients~     could be immediately treated if their condition was detected on time. Currently, there is no~     standard brain monitoring procedure for anaesthetised patients. The purpose of the proposed~     study is to optimize and validate an online monitor for neurological deterioration under~     anaesthesia based on an easily operatable EEG system comprised of 4 electrodes, a reference~     electrode and a newely developed algorithm for analyzing the EEG signal. The monitor aims at~     generating an immediate warning at the onset of neurological deterioration. For the purpose~     of technology development with a minimal sample size, it is necessary to select a patient~     population that demonstrates significant neurological dynamics under anaesthesia. We will~     therefore focus on anesthesized patients undergoing neurovascular thrombectomy after CVA.~   "
66897|NCT02691325|"~     GSK2269557 is a potent and highly selective inhaled Phosphoinositide 3-Kinase delta inhibitor~     being developed as an anti-inflammatory and anti-infective agent for the treatment of~     inflammatory airway diseases. The study will be conducted at a single centre and in 3 Parts.~     The aim of Part A and B of the study are to assess the safety, tolerability and~     pharmacokinetics (PK) single and repeat doses of a new formulation of GSK2269557 administered~     via the ELLIPTA dry powder inhaler (DPI) to healthy subjects. This is the first study in~     which GSK2269557 will be administered via the ELLIPTA DPI. Part C of the study will~     investigate the proportion of the systemic exposure that post inhalation is due to the~     swallowed fraction of the inhaled dose. Part C will also be conducted using the ELLIPTA~     device and magnesium stearate formulation. Part A will be conducted first. Part B and Part C~     may be run sequentially or in parallel. Part A is a randomized, double blind, placebo~     controlled, single dose, dose escalating incomplete block 2-period crossover study in healthy~     subjects. Subjects will be randomized to receive either one dose strength of GSK2269557 and~     placebo utilizing placebo replacement, or will receive both active dose strengths. Part B is~     a randomized, double blind, placebo controlled, repeat dose study in healthy Subjects.~     Subjects will be randomized to receive either repeat doses of GSK2269557 or placebo for 10~     days. Part C is a, randomized, open-label, crossover design to assess the systemic exposure~     of single doses of GSK2269557 administered via the ELLIPTA DPI to healthy subjects, with and~     without ingestion of activated charcoal. ELLIPTA is the registered trademark of~     GlaxoSmithKline groups of companies.~   "
66898|NCT02691312|"~     Diabetic retinopathy (DR) causes more new cases of blindness among young adults than any~     other disease. More than 90% of individuals with type 1 diabetes (T1D) will have some form of~     DR by 20 years after their diagnosis. DR is associated with long-term hyperglycemia and blood~     glucose variability, which induces vascular endothelial dysfunction and destruction in the~     retina, eventual retinal ischemia, and in the end, widespread neovascularization of the~     retina and optic disk. When these fragile vessels bleed, they can cause vitreous hemorrhage~     and loss of vision. Eventually the friable vessels fibrose and can result in retinal~     detachment or further retinal ischemia.~      Major risk factors for the development of diabetic retinopathy are time since diagnosis, age~     at diagnosis, and severity of hyperglycemia. Retinopathy most commonly occurs at least three~     years after diagnosis and most cases are diagnosed more than five years after the onset of~     T1D. Current guidelines from the American Diabetes Association (ADA) and American Academy of~     Ophthalmology (AAO) recommend that patients with T1D undergo an initial comprehensive dilated~     fundoscopic evaluation once the individual has had diabetes for 3-5 years and has either~     reached puberty or 10 years of age, whichever is earlier. These patients should receive a~     yearly exam thereafter, or every two years based upon the recommendation of an eye care~     professional. However, the prevalence of retinopathy in children is unknown and adherence to~     these guidelines, especially in youth, has proven difficult. Thus, it is important to make~     these guidelines more evidence based, as retinopathy is often asymptomatic until vision loss~     occurs. The first step in this process is the determination of the prevalence of retinopathy~     in a general population of youth with diabetes. This should be followed by determining which~     children are most at risk, so the guidelines can provide realistic and pertinent guidance to~     practitioners.~   "
66899|NCT02691299|"~     Fruquintinib/Placebo 5 mg, QD, orally administered under fasting conditions for 3 consecutive~     weeks followed by one-week off to evaluate the survival benefit of patients with advanced~     non-squamous NSCLC treated with Fruquintinib.~   "
66900|NCT02691286|"~     The aim of the study is knowing the prognostic value of circulating miRNAs in patients~     admitted to our hospital with STEMI complicated with cardiogenic shock.~   "
66901|NCT02691273|"~     It was found that an important part of the factors impeding adherence to medication and a~     healthy lifestyle among the chronically ill diabetic patients lies in proper management of~     the disease. Since it is a chronic progressive disease the caregiver is the patient~     himself.Studies have shown that software system, sending text messages / messages / reminders~     daily and answering questionnaires can improve adherence to a change in lifestyle.~      This study is an initial pilot study , which examines Feasibility ( Applicability ) of using~     a smart application that promotes a healthy lifestyle perseverance parallel use relaxation~     techniques .~   "
66902|NCT02691260|"~     The purpose of this study is to determine the feasibility of providing incentives to people~     enrolled in a weight-loss program for dietary self-monitoring and/or interim weight loss.~   "
69084|NCT02662699|"~     Anemia is a common pathology in geriatrics. According to the World Health Organization it~     affects 23.9% of subjects over 60 years in the world, and 8% of patients over 60 years in~     Europe. A prevalence that increases with the age and twice in individuals over 85 years.~   "
66903|NCT02691247|"~     This clinical trial will explore the safety and effect of autologous ex vivo expanded~     polyclonal regulatory T-cells on beta cell function in patients, aged 8 to 17, with recent~     onset T1DM. Other measures of diabetes severity and the autoimmune response underlying T1DM~     will also be explored. Eligible subjects will receive a single infusion of CLBS03 (high or~     low dose) or placebo.~   "
66904|NCT02691234|"~     Low intensity shockwaves for treating diabetic foot ulcers (DFUs) have been in evaluation for~     the past 5 years. Many researchers showed the effectiveness of Low intensity shockwaves of in~     accelerating the healing rate of non-ischemic chronic DFUs. Wang et al. showed, the use of~     Low intensity shockwaves on DFUs, significantly improved topical blood flow perfusion rate,~     increased cell proliferation and cell activity and decreased cell apoptosis.~      The present study deals with the effect of low intensity shockwaves on DFUs. Shockwave~     treatment will be done together with the standard conventional treatment for DFUs, compared~     to a control group who will receive the same conventional standard of care.~   "
66905|NCT02691221|"~     The purpose of this study is to increase use and availability, as well as assess the~     feasibility of the ReliefLink (RL) application for use in conjunction with standard care to~     promote psychological health and prevent suicidal behavior.~   "
66906|NCT02691208|"~     The patients were divided into two randomized groups with 24 patients per group, which were~     given weekly treatment for 10 weeks, one group treated with Kinesiotherapy lasting 30 minutes~     and the other group followed Kinesiotherapy the same protocol for another 30 minutes~     acupuncture using predefined points.~      The patients were assessed at baseline, after five weeks and at the end of 10 weeks.~     Responded to an evaluation form about their registration and social data. The physical~     examination included the assessment of shoulder range of motion, shoulder muscle strength,~     circumference of the upper limbs and the presence of pain. Questionnaires of quality of life,~     upper limb function and depression.~   "
66907|NCT02691195|"~     Regional anesthesia improves quality of recovery after surgery in many studies.~     Ultrasound-guided serratus plane block is a novel technique which may be a viable alternative~     to current regional anesthetic techniques. This randomized, controlled trial is to examine~     the effects of ultrasound-guided serratus plane block anesthetic on the QoR after breast~     tumor resection.~   "
66908|NCT02691182|"~     Children between the ages of 6-12 years who are diagnosed with impulsive aggression comorbid~     with ADHD and have participated in the 810P301 or 810P302 study are invited to participate in~     this study. This is a Phase 3 open label extension (OLE) study with the objective of~     collecting long-term safety data on the use of SPN-810 in treating impulsive aggression in~     pediatric subjects with ADHD, when taken in conjunction with standard ADHD treatment. After~     confirmation of eligibility, all subjects will be treated with SPN-810.Subjects will be given~     a choice to extend participation in this study every 6 months for up to 36 months.~   "
66909|NCT02691169|"~     There are several new therapies available to treat men with advanced prostate cancer;~     however, the decision making tools needed to determine the best treatment for these patients~     are noticeably absent. The prostate-specific membrane antigen (PSMA) is increasingly being~     recognized as an important target for prostate cancer imaging and determining the most~     effective therapy. Accordingly, a wide variety of agents are being used to image PSMA. One of~     these agents is 18F-DCFPyL. In this study the investigators will image men with advanced~     prostate cancer using 18F-DCFPyL and a positron emission computed tomography (PET/CT)~     scanner. The investigators will compare the results of 18F-DCFPyL PET/CT for the detection of~     metastases and monitoring the effects of therapy with conventional imaging (CT, bone scan)~     and clinical follow-up. In this way, the investigators will evaluate the benefit of using~     18F-DCFPyL PET/CT to decide what is the best treatment strategy for a man with advanced~     prostate cancer.~   "
66910|NCT02691156|"~     Most preterm newborns are managed by phototherapy to reverse hyperbilirubinemia with the~     intent to prevent bilirubin neurotoxicity. A threshold-based relationship between a specific~     total bilirubin level and need for intervention has been elusive. This is most likely due to~     other biomarkers such as hemolysis, developmental maturation, concurrent illnesses, or even~     interventions, may impede bilirubin/albumin binding. The over-prescription of phototherapy~     has impacted clinical and family-centered care, and in the extreme preterm infants, it may~     have augmented their risk of mortality. Thus, the opportunity to individualize phototherapy~     in in order to reduce its use is unique. The investigators have assembled a transdisciplinary~     team to examine critical unanswered questions including the role of bilirubin binding~     capacity (BBC) of an individual during the first week of life in the context of clinical~     modifiers and antecedents for a domain of bilirubin-induced neurologic disorders, that~     includes neuro-anatomical, hearing, visual and developmental processing impairments. In this~     study, the investigator will evaluate two new innovative nanotechniques to quantify bilirubin~     load for the first time in the context of a clinical decision algorithm to identify those~     most at risk for any bilirubin-related neurotoxicity. The investigators anticipate that~     knowledge gained from this study will lead to ethically testable hypotheses to individualize~     the prescription of phototherapy.~   "
66911|NCT02691143|"~     The purpose of this study is to determine if post-manipulation elastic therapeutic tape (ETT)~     with TheraBand® Kinesiology Tape to neck pain patients can impact neck range of motion (ROM)~     and post-manipulation pain. A convenience sample of 50 patients, between the ages of 18-64,~     who present with acute non-complicated postural neck pain will be recruited from an~     outpatient chiropractic clinic. Upon providing consent to participate, patients will be~     randomly assigned into 2 groups; Control Group (manipulation only) and Tape Group~     (manipulation plus tape). Pain and neck ROM will be recorded at 3 different intervals: (1)~     pre-cervical manipulation, (2) within 5 minutes of cervical manipulation, (3) with 24-48~     hours after manipulation.~   "
66912|NCT02691130|"~     Multimeric-001 (M-001) contains conserved, common linear influenza epitopes that activate~     both cellular and humoral arms of the immune system against a wide variety of influenza A and~     B strains. Apart from its direct action, M-001 is an attractive candidate for priming immune~     responses to pandemic influenza vaccine in the adult population. The current clinical study~     was designed to assess M-001's standalone and priming action in subjects aged 18-60 years~     old.~      This is a Phase IIb study comprising 222 participants. Eligible subjects were randomized to~     receive two sequential intramuscular injection of 0.5mg or 1.0mg M-001 (treatment), or two~     placebo (saline) injection, before receiving the sub optimal dose of H5N1 pandemic vaccine.~   "
66913|NCT02691117|"~     Management of pediatric alopecia is particularly challenging given the chronicity of the~     condition, limited therapeutic response and devastating psychological effects. There is a~     paucity of safe and effective therapies in this population.~      The investigators propose to conduct and open label, prospective cohort pilot study using~     topical garlic concentrate ( GarlicRich) for treatment of children with alopecia areata.~     Study medication will be applied topically on affected area of the skin daily for 6 months.~     Follow up visits will occur monthly to access the efficacy and safety of the proposed~     treatment .~   "
66914|NCT02691104|"~     The investigators are carrying out a feasibility study to explore whether an app for physical~     activity in Chronic Obstructive Pulmonary Disease (COPD) is acceptable to people with the~     condition and to healthcare professionals who help patients manage the condition.~   "
66915|NCT02691078|"~     Evaluation of the properties of the image capture test using 99m Tc - HYNIC -TOC EDDA~     (octreotide labeled with 99mTc) for the diagnosis of neuroendocrine tumors compared to the~     111In - DTPA-octreotide.~   "
66916|NCT02691065|"~     Human immunodeficiency virus (HIV) infection damages body defence mainly by affecting two~     important white blood cells called cluster of differentiation (CD4) T cells and monocytes.~     This immune dysfunction leads to persistent inflammation, which is partially resolved with~     long-term anti-HIV therapy. Importantly, such inflammation increases risk for cardiovascular,~     diabetes, and kidney diseases. The causes of this inflammation are largely unknown and~     include HIV itself, presence of other infections, lifestyle characteristics like increased~     cholesterol levels, obesity, smoking and alcohol abuse. In addition, inflammation can be~     driven by certain type of anti-HIV therapy called protease inhibitor (PI). PI has been~     associated with an increase of cholesterol and may contribute to inflammation. A new class of~     medication that is now available in Canada called integrase inhibitor (II) may have a lesser~     or no effect on cholesterol levels. Therefore, it is important to study the effect of II on~     cholesterol levels and inflammation.~      The purpose of this study is to assess the inflammatory changes, in the blood of persons~     treated with PI that will switch to the II or may remain on their PI-containing regimen. By~     comparing persons continuing their current PI-based regimen with those who switch to II-based~     regimen, we will know if the change from PI to raltegravir (Isentress), a type of II,~     decreases lipids and inflammatory markers.~      The adult persons living with HIV, who are on PI-based therapy for more than a year, with any~     CD4 T cell count and plasma viral load below level of detection, will be invited to~     participate in the study. 40 study participants will be selected by randomization (like a~     toss of a coin) to either continue PI-based regimen (20 participants) or switch to~     raltegravir-based regimen (20 participants) for a period of 12 months. Blood samples of the~     study participants will be drawn before, during and at the end of study to evaluate changes~     in markers of inflammation, cholesterol level and CD4 T cell and monocyte function. No~     experimental anti-HIV medication will be used; change of therapy will include raltegravir~     which is one of currently recommended medications to treat HIV in Canada.~      This study will be able to answer this important question whether inflammation can be~     decreased by switching therapy from PI-based therapy to raltegravir-based therapy.~     Ultimately, information provided by this study will contribute to the health of persons~     living with HIV.~   "
66917|NCT02691052|"~     Current studies resulted in a superiority of a combination of nab-paclitaxel and gemcitabine~     vs. gemcitabine mono therapy, but no data are available yet on the quality of life (QoL)~     under this combination therapy. In the framework of a German multicenter prospective,~     observational study ('QoliXane'), detailed QoL-data are now collected. QoL development under~     treatment will be analyzed and data will be compared to existing data of the gemcitabine mono~     therapy.~      QoL and course of therapy are collected using the EORTC C30 questionnaires once a month over~     a 6-month period. Additionally patients are requested to answer a supplementary questionnaire~     addressing e.g. fears related to QoL deterioration and side effects of chemotherapy. Primary~     endpoint is the proportion of patients with maintained Global Health Status/QoL at 3 months~     (10 points threshold). 600 patients shall be enrolled at about 90 study sites in Germany.~   "
66918|NCT02691039|"~     The purpose of this project is to create a database to collect information about the NEW~     Keiki Program. The information collected for this project will be used to evaluate the~     program. The NEW Keiki program promotes healthy lifestyles and behavior changes.~   "
66919|NCT02691026|"~     This is phase II, single arm, open-label, interventional trial of pembrolizumab (MK-3475) in~     subjects with metastatic or locally advanced/unresectable or metastatic malignant peripheral~     nerve sheath tumour (MPNST).~      The patients will be treated with pembrolizumab for up to 10 cycles.~      Primary objective is to evaluate the percentage of patients with curatively unresectable~     MPNST who have achieved clinical response; complete response (CR), partial response (PR), or~     stable disease (SD) at 18 weeks as assessed by the Investigator, by using RECIST, v1.1.~   "
66920|NCT02691013|"~     Sleep deprivation is known to affect brain function but is often ignored in the sickest~     patients including those in the intensive care unit after major surgery. In these patients,~     the levels of melatonin can also be altered. Melatonin is a hormone secreted in the brain~     that maintains the body's sleep-wake, or circadian, cycle. The investigators want to test~     whether improving sleep quality affects the risk of developing confusion (delirium) in~     patients having clot removed from their lung (open heart surgery). In order to improve sleep~     quality, the investigators will conduct a study of Ramelteon, a medication that mimics the~     activity of melatonin and measure its effects on levels of melatonin and monitor sleep.~   "
66921|NCT02691000|"~     The Light-Heart study is a randomized, double-blind, controlled trial investigating the~     effects of bright white light (BWL) therapy on depressive symptoms, quality of life, and~     functioning in patients with Stage B heart failure. The study is a randomized, double-blind,~     controlled trial of 8 weeks of morning BWL therapy compared with morning dim red light (DRL)~     treatment in older (60 years or older) 122 Stage B (early, asymptomatic) HF patients.~   "
66922|NCT02690987|"~     The Gut Hormones in Addiction study is a proof-of-concept experimental medicine human study~     to answer the following questions:~        1. Does the administration of the hormone desacyl ghrelin reduce core behavioural~          components of addiction in dependent individuals who have recently stopped smoking~          tobacco or drinking alcohol, or overweight/obese subjects?~        2. Does the administration of the drug Exenatide reduce core behavioural components of~          addiction in dependent individuals who have recently stopped smoking tobacco or drinking~          alcohol, or overweight/obese subjects?~        3. Does the administration of desacyl ghrelin or Exenatide reduce reward responses to~          high-calorie foods and appetite in dependent individuals who have recently stopped~          smoking tobacco or drinking alcohol, or overweight/obese subjects?~   "
66923|NCT02690974|"~     The primary purpose of the study will be to describe the tolerability of treatment with the~     optimal dose of LCZ696 (97.2 mg sacubitril / 102.8 mg valsartan bid), over six (6) months, in~     patients with heart failure with reduced ejection fraction (HFrEF) in Canada.~      The study will also describe the overall tolerability, effectiveness and safety of LCZ696 for~     the management of HFrEF over 12 months of treatment, as well as describe the patterns of~     LCZ696 up and down dose titrations occurring during the management of patients with HFrEF.~   "
66925|NCT02690948|"~     This phase 1/2 trial studies how well pembrolizumab with or without vismodegib works in~     treating patients with skin basal cell cancer that has spread to other places in the body or~     cannot be removed by surgery. Monoclonal antibodies, such as pembrolizumab, are checkpoint~     inhibitors that stimulate immune response. Vismodegib may stop the growth of tumor cells by~     blocking signals needed for cell growth.~   "
66926|NCT02690935|"~     The primary objective of this study is to demonstrate the superiority of 2L®ALERG over~     placebo in terms of efficacy on the symptoms of allergic rhinitis and allergic~     rhinoconjunctivitis in patients with seasonal allergy to grass pollen, corrected according to~     rescue medication intake. The secondary objectives are to compare the allergy symptoms, the~     rescue medication intake, the quality of life and the safety in patients treated with~     2L®ALERG or with a placebo.~      This is a multicentre, randomized, double-blind, two-parallel group, interventional~     placebo-controlled study with a notified homeopathic medication, marketed since 2002.~      Fifty patients will be recruited per group to achieve 40 cases completed per group, i.e., a~     total of 100 patients included for 80 cases completed.~      Screening will be done before the peak of pollination and the treatment will be set up two~     months before traditional pollen peak, then visits at 3 months and 6 months, or end of the~     peak.~      The treatment will consist of 1 capsule daily, fasting morning, following the numerical order~     of 1 to 10 capsules for 6 months.~      The placebo will have the same form, colour, taste and aspect. The allowed concomitant~     treatments are the already established treatments for associated pathologies not liable to~     have an impact on the proper conduct of the study and the rescue medications allowed in the~     first-line adjuvant treatment (oral or topical antihistamines [nasal or eye] and eye~     cromoglycate, topical nasal corticosteroids [in case of failure or insufficiency of those~     above]).~      The prohibited treatments are the oral or injectable corticosteroids and the~     anti-leukotrienes.~   "
66927|NCT02690922|"~     The aim of our study is to improve the major molecular remission(MMR) rate and reduce the~     cost to treat ph(+) Acute Lymphoblastic Leukemia (ALL) by adjusting chemotherapy regimens and~     the dosage of Tyrosine Kinase Inhibitor (TKI). lower the classification of chemotherapy~     drugs, lower the side effect brought by which this would be a grateful news for the patients~     once this regimens gain a successful result, which is also the final aim of our efforts.~   "
66928|NCT02690909|"~     The ReDy™ System (Renal Dynamics) is a renal denervation device incorporating a variety of~     ablation features and technical improvements over previously designed systems into a single~     product. It is intended to treat uncontrolled (drug-resistant) hypertension by RF ablation of~     the sympathetic nerve network surrounding the renal arteries.~      This study will be carried out to validate the safety and the efficacy of the ReDy™ Renal~     Denervation device and to demonstrate that it performs according to its intended use, i.e.~     the treatment of patients with uncontrolled hypertension.~   "
66929|NCT02690896|"~     The purpose of this study is to examine the effectiveness of support group intervention for~     primary caregivers of a person with dementia or similar cognitive impairment.~   "
66930|NCT02690883|"~     This is a multi-center, randomized, parallel study to evaluate effect of exenatide on~     24h-UAER in patients with diabetic nephropathy.~      Screening will be made to select eligible participants before intervention. The trial will~     include 2-week run-in period of stable doses of glargine plus lispro insulin and 24-week~     treatment period. After the run-in period, patients were randomly assigned to one of two~     groups for antihyperglycaemic therapies for a total of 24-weeks: glargine plus exenatide and~     continued glargine plus lispro insulin. The treatment of exenatide will be initiated by 5ug~     bid, and uptitrated to 10 ug bid after 4 weeks and then maintained at 10ug bid until the~     completion of the study. Lispro insulin will be initially treated according to the insulin~     dosage of previous antihyperglycaemic therapies, and further titrated up at 4-week intervals~     until to reach the target fasting blood glucose (FPG).~   "
66931|NCT02690870|"~     The purpose of this prospective cohort study is to compare IVF outcome between tamoxifen and~     clomiphene citrate in mild stimulation.~   "
66932|NCT02690857|"~     Patients with Cystic Fibrosis have increased oxidative stress and impaired antioxidant~     systems. Under certain conditions, docosahexaenoic acid (DHA) intake may have a favorable~     role in reducing redox status.~      In this randomized, double-blind, cross-over study, DHA (Pro-Mind) and placebo (sunflower~     oil) capsules, will be given, daily to 10 patients, 5 mg/kg for 2 weeks then 10 mg/kg for the~     next 2 weeks. Biomarkers of lipid peroxidation and vitamin E levels will be measured. Plasma~     and platelet lipid compositions will be determined.~   "
66933|NCT02690844|"~     What affect does the use of a mucoadhesive drug delivery system (Mucolox®) compounded with~     clonazepam have in the treatment of burning mouth syndrome?~      There are no clinical trials reported in the literature that evaluate the use of a~     mucoadhesive vehicle to deliver clonazepam into the oral cavity and treat burning mouth~     syndrome. The use of a mucoadhesive may help to increase surface contact and elicit a greater~     reduction in symptoms.~   "
66934|NCT02690831|"~     The aim of this study is to assess if an intervention of manual therapy and motor control~     exercises combined with an inspiratory muscle training program is more effective than an~     inspiratory muscle training program alone in increasing the maximum inspiratory pressure in~     patients with asthma. In addition, the study pretends to evaluate the changes caused by the~     intervention regarding possible postural changes and thoracic diameter.~   "
66935|NCT02690818|"~     The purpose of this pilot study is to determine whether regularly scheduled medication~     reminder text messages (SMS) are effective in increasing latent tuberculosis infection (LTBI)~     treatment completion.~   "
66936|NCT02690805|"~     The purpose of this research study is to investigate the accuracy of a breast imaging system~     that measures the uptake of the injected radioactive tracer by gamma-ray imaging, known as~     scinti-mammography (SMM), to diagnose the residual breast cancer after neoadjuvant~     chemotherapy (NAC) treatment by comparing to MRI.~   "
66948|NCT02690649|"~     This is an interventional study designed to develop patient focused strategies that improve~     adherence to anticoagulant medication in patients with non-valvular atrial fibrillation (AF).~     Outcomes of this work include a novel intervention, as well as information regarding patient~     preferences for tailored education.~   "
69148|NCT02661854|"~     The purpose of the study is to evaluate the more efficient dose for the treatment of~     rhinitis/rhinoconjunctivitis against mite allergy~   "
66937|NCT02690792|"~     One-third of the US population has non-alcoholic fatty liver disease (NAFLD) due to obesity~     and ~8 million of these individuals have a progressive form of the disease, non-alcoholic~     steatohepatitis (NASH). Currently, there are no noninvasive ways to determine which~     individuals with NAFLD will develop NASH. This is of medical importance since NASH can be a~     prelude to the development of end-stage liver disease.~      The study of NAFLD has been limited by several factors, including the difficulties associated~     with studying liver metabolism in vivo in humans. Our group has pioneered new methods that~     use nuclear magnetic resonance (NMR) to measure intermediary hepatic metabolism in humans~     with a goal of directly studying the pathophysiology of bland steatosis and NASH. In this~     study, these noninvasive methods will be used to characterize and compare the metabolic~     alterations that accompany bland steatosis and NASH and test the hypothesis that detects if~     hepatic mitochondrial metabolism contribute to both disorders. Such characterization is~     fundamental to establishing a rational approach to the prevention and treatment of NAFLD and~     may provide simple, non-invasive methods to differentiate benign and progressive forms of~     NAFLD.~      This proposal will be addressed via separate isotopic studies occurring at different time~     points during a prolonged fast. In subjects with NAFLD, these studies will be carried out~     before and after treatment with Vitamin E or placebo.~      Healthy subjects will participate in initial baseline studies only without Vitamin E or~     placebo intervention.~      The study is designed to harness the physiologic changes that occur with short- and long-term~     fasting to provide a rapid and cost-effective method to accomplish the aims of the~     application.~   "
66938|NCT02690779|"~     The study will consist of a prospective observational period performed in the GI Endoscopy~     Lab. The objective is to document the quality of bowel preps in patients undergoing a~     screening colonoscopy with and without an educational intervention.~   "
66939|NCT02690766|"~     Investigators proposed to refine and test the feasibility and acceptability of a 4-month~     multi-modal lifestyle intervention in African American female breast or endometrial cancer~     survivors diagnosed with type 2 diabetes.~   "
66940|NCT02690753|"~     The prevalence of pressure ulcer in hospitals is 7,3% - 23%. The primary etiological factors~     are pressure or pressure combined with shear. Prevention is very important and comprises:~     preventive skin care including cleansing and protecting the skin from exposure to moisture,~     the systematic repositioning of the patient, the offloading of the heels from the surface of~     the bed, the use of adequate bed support surfaces and an adequate nutritional status. The~     development and implementation of a risk based prevention plan for individuals identified as~     being at risk is strongly recommended. Limited compliance exists towards pressure ulcer~     preventive interventions. 25,5% of the patients at risk receive fully adequate prevention in~     bed. The reposition frequence is adequate in 55% of patients at risk. There is a lack of~     rigorously performed research addressing the effectiveness of devices or risk based protocols~     to improve compliance. Health care budgets are limited, priorities should be set in the~     allocation of health care resources.~      The primary aim of this study is to compare the effectiveness of the turn and position system~     (Prevalon®Turn and Position System 2.0, SAGE) versus standard care to improve reposition~     frequence in patients at risk. The second aim is to compare the effectiveness of a tailored~     protocol versus standard care to improve reposition frequence in patients at risk. The third~     aim is to compare the effectiveness of standardized incontinence care versus standard care to~     improve the incidence of pressure ulcers and incontinence-associated dermatitis (IAD). Also a~     health economic evaluation will be performed.~      The study will be performed in hospital setting (university and general hospitals) in a~     random sample of 226 patients aged > 18 who are at risk of developing pressure ulcers.~     Patients will be recruited from three types of wards: intensive care units, geriatric wards~     and rehabilitation wards. Patients will be included in the study for a period of 8 days.~   "
66941|NCT02690740|"~     The clinical relevance of an allergen-specific sensitization is proven e.g., by allergen~     challenge tests in clinical routine. Several protocols for different challenge tests such as~     nasal (NPT), bronchial (BPT) or conjunctival provocation test (CPT) have been proposed.~     Beneath others, the CPT is broadly used in both clinical trials and routine because of its~     feasibility.~      However, there is no internationally harmonized standard regarding the clinical~     interpretation of CPT results as well as a lack of validation of a specific outcome score.~     Therefore, this trial aims to investigate and validate a new scoring system for CPT results~     in order to provide this test as a useful method in future clinical trials.~   "
66942|NCT02690727|"~     This is a single centre, open label, randomized, two-treatment, two-period, two-sequence,~     single dose crossover food effect study in 18 subjects. The subjects will receive the study~     medication under either fed or fast during each treatment period.~   "
66943|NCT02690714|"~     This is a Phase 2/3 pivotal study of ProMetic Plasminogen (Human) Intravenous Lyophilized~     solution.~      The primary objective of the study is to achieve a consistent increase of individual trough~     plasminogen activity levels.~   "
66944|NCT02690701|"~     This study will evaluate the effect of secukinumab compared to placebo on aortic vascular~     inflammation in adult patients who have moderate to severe plaque psoriasis that is poorly~     controlled by current psoriasis treatments.~   "
66945|NCT02690688|"~     Dynamic preload variables like pulse-pressure and stroke volume variation may be used to~     predict fluid responsiveness in patients during controlled ventilation. Previous work has~     shown that a rapid decrease in intra-abdominal pressure may lead to an increase in dynamic~     preload parameters, suggestive of a fluid deficit - despite fluid status had not changed [van~     Lavieren M 2014].~      The results of this study are limited by the fact that a non-invasive and uncalibrated~     hemodynamic monitoring system (Nexfin™) was used.~      The present study thus aims to evaluate the effects of abdominal pressure changes on dynamic~     preload parameters (PPV and SVV) employing conventional, invasive hemodynamic monitoring~     (Vigileo®, Edwards Lifescience) in open abdominal surgery as well as in minimal invasive~     surgical procedures with pneumoperitoneum.~   "
66946|NCT02690675|"~     Objective: To evaluate the effect of Iron supplement with two different amounts (one in the~     higher limit and another in the lower limit of the suggested amount) according to the~     presence of mutations in the HFE gene in the physical, immune and neurobehavioral development~     in the 6 to 12 moth toddlers.~      Methodology: Subjects: 340 toddlers coming from Paediatric Serves of Sant Joan Hospital.~     Methods: At 6 and 12 months it done clinical history, food registry, biochemist~     determinations: haemoglobin, iron, transferrin, ferritin, reactive C protein and immune~     response (IL4, IL10, IL6 IFN, IgA, IgM, IgG, IgE). Mutations in the HFE gene: C282Y, H63D,~     S65D and hepcidin gene. Mental, psychomotor and behavioual development (Bayley Scales of~     Infant Development 2on Edition: 1993). We evaluate the level of language and communication~     (MacArthur), regulation and sensory process (Infant Toddler Symptom Checklist), familiar and~     environment surroundings (Scale Health General Parental Stress Index).~   "
66947|NCT02690662|"~     The objective of this study is to evaluate the influence of low-calorie diet on serum and~     urinary metabolic parameters of obese adults with urinary calculi and lithogenic metabolic~     abnormalities.~   "
66949|NCT02690636|"~     Breast cancer patients operated with modified radical mastectomy or breast conservative~     surgery will be randomized for either adjuvant conventional radiotherapy versus~     hypofractionated radiotherapy for chest wall and axilla or breast and axilla.~      The patients will be recruited for one year and will be followed for 5 years by monitoring~     local recurrence, cosmetic outcomes, health economic perspectives, and arm lymph edema.~   "
66950|NCT02690623|"~     Background. Hospitalists predominantly engaged in inpatient care constitute a fundamental,~     poorly assessed change in medical care. The University of Texas Houston Pediatrics Department~     is developing a Hospitalist Division to staff Children's Memorial Hermann Hospital.~     Demonstration of its benefits and cost-effectiveness is important to secure adequate,~     sustained hospital or 3rd-party reimbursement.~      Design. Prospective step wedged quality improvement (QI) study with pediatric hospitalists~     sequentially assuming 24/7 responsibility for each of the 4 pediatric inpatient services over~     2-3 years. This design allows within- and between-group analyses and is particularly~     desirable for evaluating interventions likely to be beneficial that will be given stepwise to~     an increasing % of patients.~      Intervention. Faculty of the new Pediatric Hospitalist Division will initially become~     responsible 24/7 for 1-2 of the 4 services now staffed by the General Pediatric Division.~     Currently, each pediatric service admits every other patient without regard to diagnosis,~     resulting in quasi-random patient assignment.~      Outcomes: Total hospital days (including 30-day readmissions); intubation; pediatric~     intensive care unit (ICU) admissions; parent, nurse, and resident satisfaction; and costs~     assessed using state-of-the-art methods and expressed from the health system, medical school,~     and hospital perspectives.~      Hypotheses. Hospitalists will improve clinical outcomes and parent, nurse, and resident~     satisfaction and be cost-effective (primary outcome), assessed by net cost or savings per~     hospital day prevented (health system perspective).~      Analyses. Frequentist and Bayesian analyses to assess the probability of benefit and of~     cost-effectiveness.~   "
66951|NCT02690610|"~     This prospective study will include 30 patients with hilar/mediastinal lymph nodes detected~     by thoracic CT either there was a known lung malignancy (for staging purpose) or not (for~     diagnosing purpose).~      All patients will undergo to ROSE during EBUS-guided TBNA. Mediastinoscopy or other invasive~     procedures will be performed if EBUS-guided TBNA doesn't provide representative material.~   "
66952|NCT02690597|"~     Screening of anxiogenic part of pain is an imperative during a medical pain consultation. The~     actual tools for evaluation of this specific part are complex and time consuming.~      To date, it lacked a reliable and reproductive tool to quickly evaluate anxiety of patient in~     pain. The purpose of this study is to demonstrate the pertinence and validity of anxiety~     analogic visual scale by comparison with the actual reference the self-assessment~     questionnaire State Trait Inventory Anxiety Y-A form.~   "
66953|NCT02690584|"~     The purpose of this open trial is to investigate the feasibility, acceptability, and effect~     of metacognitive therapy in patients with prolonged post-concussive symptoms after mild~     traumatic brain injury.~   "
66954|NCT02690571|"~     Air pollution is a global environmental and health concern, contributing to onset and~     deterioration of respiratory and cardiovascular diseases. As climate change and dependence on~     diminishing fossil fuel supplies have taken center stage in political and scientific debates,~     renewable carbon-neutral fuels like biodiesel receive increasing attention. The most common~     biodiesel within the European Union, rapeseed oil methyl ester (RME) is perceived to be a~     green fuel, as it is sustainable and of biological origin, and therefore is often predicted~     to be less harmful to human health. Whilst replacing petrodiesel with biodiesel may have~     advantageous ecological impacts, consequences to respiratory health remained largely~     unexplored.~      The purpose of the current study is to evaluate whether inhalation of 100% RME biodiesel~     exhaust would result in an acute airway inflammatory response in healthy human subjects, as~     shown previously following exposure to petrodiesel exhaust.~   "
66955|NCT02690558|"~     The purpose of this study is to evaluate whether adding pembrolizumab (Keytruda) to the~     combination of gemcitabine and cisplatin will improve shrinkage of the tumor before having a~     cystectomy, for people with muscle-invasive bladder cancer (MIBC).~   "
66956|NCT02690545|"~     The body has different ways of fighting infection and disease. No single way seems perfect~     for fighting cancer. This research study combines two different ways of fighting disease:~     antibodies and T cells. Antibodies are proteins that protect the body from disease caused by~     bacteria or toxic substances. Antibodies work by binding those bacteria or substances, which~     stops them from growing and causing bad effects. T cells, also called T lymphocytes, are~     special infection-fighting blood cells that can kill other cells, including tumor cells or~     cells that are infected. Both antibodies and T cells have been used to treat patients with~     cancers. They both have shown promise, but neither alone has been sufficient to cure most~     patients. This study is designed to combine both T cells and antibodies to create a more~     effective treatment called autologous T lymphocyte chimeric antigen receptor cells targeted~     against the CD30 antigen (ATLCAR.CD30) administration.~      In previous studies, it has been shown that a new gene can be put into T cells that will~     increase their ability to recognize and kill cancer cells. The new gene that is put in the T~     cells in this study makes an antibody called anti-CD30. This antibody sticks to lymphoma~     cells because of a substance on the outside of the cells called CD30. Anti-CD30 antibodies~     have been used to treat people with lymphoma, but have not been strong enough to cure most~     patients. For this study, the anti-CD30 antibody has been changed so that instead of floating~     free in the blood it is now joined to the T cells. When an antibody is joined to a T cell in~     this way it is called a chimeric receptor. These CD30 chimeric (combination)~     receptor-activated T cells seem to kill some of the tumor, but they do not last very long in~     the body and so their chances of fighting the cancer are unknown.~      The purpose of this research study is to establish a safe dose of ATLCAR.CD30 cells to infuse~     after lymphodepleting chemotherapy and to estimate the number patients whose cancer does not~     progress for two years after ATLCAR.CD30 administration. This study will also look at other~     effects of ATLCAR.CD30 cells, including their effect on the patient's cancer.~   "
66957|NCT02690532|"~     This study will assess the effect of gluten on gut barrier function. Investigators at the~     Mayo Clinic have developed a new gut permeability test using rhamnose (sugar & water~     solution), and are hoping to prove its effectiveness in a clinical setting.~   "
66958|NCT02690519|"~     At least 6 cystic fibrosis patients with the S1251N mutation will be treated for 4 weeks,~     consisting of two consecutive treatment periods of two weeks evaluating one dose of GLPG1837~     each. After the treatment period, there is a 7-10 days follow-up period.~      During the course of the study, subjects will be examined for any side effects that may occur~     (safety and tolerability).~      Changes in sweat chloride will be assessed as biomarker from baseline onwards, and changes in~     pulmonary function (efficacy) will be explored throughout the study. The amount of GLPG1837~     present in the blood (pharmacokinetics) will also be determined.~   "
66991|NCT02690077|"~     The purpose of this study is to determine if patient birthing experiences differ between the~     family-centered and traditional cesarean methods. We hypothesize that the family-centered~     cesarean method will lead to more unique and personalized cesarean birthing experiences~     without increasing the risks of adverse neonatal and maternal outcomes from those documented~     with the traditional cesarean.~   "
66959|NCT02690506|"~     Pregabalin, an anticonvulsant is widely used for treatment of neuropathic pain. Recently, it~     was reported that premedication of pregabalin before general anesthesia is effective to~     reduce postoperative pain. Up to date, there is no study about the effect of premedication of~     pregabalin on the spinal anesthesia. Therefore, in this study, investigators investigate the~     effect of premedication of pregabalin on the spinal anesthesia.~   "
66960|NCT02690493|"~     The purpose of this study is to determine whether acupuncture and taping are effective in the~     treatment of spastic upper limb after stroke.~   "
66961|NCT02690480|"~     This is an international, multicentre, double-blind, controlled, randomized phase II study~     comparing the efficacy and safety of fulvestrant in combination with palbociclib versus~     fulvestrant plus placebo in postmenopausal women with HR-positive/HER2-negative metastatic~     breast cancer who have received ≥5 years of endocrine therapy in the adjuvant setting as~     treatment for early disease and remained disease free for > 12 months following its~     completion or have de novo metastatic disease. Patients must have at least one lesion~     (measurable and/or non-measurable) that can be accurately assessed at baseline and is~     suitable for repeated assessment by CT, MRI or plan x-ray. Patients with bone-only disease~     must have a lytic or mixed (lytic + blastic) lesion, which has not been previously irradiated~     and can be accurately assessed by CT/MRI or x-ray. Approximately 190 patients will be~     randomized 1:1 between the experimental arm (approximately 95 patients treated with~     fulvestrant plus palbociclib) and the control arm (approximately 95 patients treated with~     fulvestrant plus placebo).~      Primary Objective:~      • To compare the efficacy of fulvestrant in combination with palbociclib versus fulvestrant~     plus placebo in terms of the rate of Progression-Free Survival (PFS) at 1 year in~     postmenopausal women with HR-positive/HER2-negative metastatic breast cancer previously~     treated with endocrine therapy for at least 5 years and remaining disease free for more than~     12 months following its completion or have de novo metastatic disease~   "
66962|NCT02690467|"~     The purpose of this study is to determine the non-inferiority of a new Pic Insupen 34Gx3,5mm~     needle vs. a 32Gx4mm needle in terms of metabolic control, safety and acceptability in~     patients with diabetes treated with insulin.~   "
66963|NCT02690454|"~     Ticagrelor is a direct-acting, reversible platelet P2Y12 receptor inhibitor recommended by~     the recent European Society of Cardiology guidelines in patients with acute coronary~     syndromes (ACS) (class of recommendation I, level of evidence B). Ticagrelor inhibits~     platelet function stronger, faster and more consistently than clopidogrel, the former~     standard of antiplatelet therapy. In the landmark PLATO trial (Study of PLATelet inhibition~     and patient Outcomes), ticagrelor therapy as compared with clopidogrel treatment was~     associated with the reduced occurrence of major adverse cardiovascular events and all-cause~     mortality, but also resulted in a small, but statistically significant, increase in the rate~     of major bleeding. The optimum choice of antiplatelet treatment, aimed to provide each~     patient with maximum protection against ischemic events, while minimizing the risk of~     bleeding complications, is the challenge of contemporary ACS therapy. The tool which may help~     physicians and facilitate clinical decision making is platelet function testing. According to~     the guidance of both European and American groups of experts, there are three currently~     recommended platelet function tests, namely the VerifyNow device, the Multiplate analyzer and~     the Vasodilator Stimulated Phosphoprotein Phosphorylation (VASP) assay. It needs to be~     emphasized that none of these three methods is preferred over others. So far there are no~     studies linking pharmacokinetic analysis of ticagrelor and its active metabolite with~     comparative evaluation of platelet reactivity. The aim of this trial is to assess the~     relationship between concentrations of ticagrelor and its active metabolite (AR-C124910XX)~     and results of all three recommended platelet function tests in patients with myocardial~     infarction. Patients who receive GP IIb/IIIa receptor inhibitor will be excluded from the~     primary analysis.~      Statistical analysis: The correlation will be assessed using correlation coefficients and~     intraclass correlation coefficients. while the agreement between the results of the compared~     platelet function tests will be measured using the Kappa statistic and Bland-Altman analysis.~   "
66964|NCT02690441|"~     Generalised anxiety disorder (GAD) is a severe and debilitating anxiety disorder that is~     highly prevalent among older adults. Anxiety and GAD is a well-documented risk factor for the~     development of other severe conditions such as depression and dementia, and effective~     treatments are called for. However, recommended treatment for GAD has consistently been found~     to yield blunted response rates for older adults compared to younger patients.~      The purpose of this study is to evaluate the effects of exercise-augmented cognitive~     behaviour therapy for older adults with GAD. Exercise augmented CBT is expected to yield~     better results than standard CBT in terms of greater reduction of symptoms and increased~     rates of remission. The investigators will also investigate the effects of treatment on~     biological, physiological and neuropsychological measures.~   "
66965|NCT02690428|"~     Thermotherapy is a technology aiming at destroying tissue, for example tumor tissue.~     Immunostimulating Interstitial Laser Thermotherapy (imILT) is a specific form of~     thermotherapy, which, in addition to destroying tumor tissue, has been optimized to cause a~     tumor specific immunologic response. In laboratory animals the imILT method has also been~     shown to induce a so called abscopal effect. This means that when one tumor is treated with~     imILT other, untreated, tumors also decrease in size. The immunologic response has previously~     been characterized in breast cancer patients after receiving imILT treatment , and presumed~     abscopal effects induced by imILT have also been described in a malignant melanoma patient.~      The purpose of this trial is to evaluate efficiency when it comes to local tumor destruction~     of the imILT treatment method in patients diagnosed with solid tumors. The purpose is also to~     investigate the functionality and safety as well as understanding of the subsequent~     immunological effects. Since immunologically based treatment of various solid tumors is under~     intense review with so called immune checkpoint inhibitors this trial will also provide~     valuable information on how imILT, in the future, could be combined with these new and, for~     some patients, very effective treatment regimens.~      The treatment method has successfully been used for treatment of patients with breast cancer~     and malignant melanoma. Treatment of breast cancer patients caused an increase of cytotoxic T~     lymphocytes in the treated tumor, as well as activated dendritic cells at the tumor border.~     Regulatory T lymphocytes decreased in the regional lymph nodes.~      This trial is explorative, prospective, open and non-randomized. Thirty patients diagnosed~     with solid tumors will be treated in this trial, which is estimated to be carried out during~     a time period of 18 months.~   "
66966|NCT02690415|"~     Infections due to S. aureus are a major healthcare burden. Currently there is not an~     effective way to prevent S. aureus infection. Treatment failure can happen in up to 20% of~     patients with SSTI and mean additional cost per patient can be over $1500. Antibiotics are~     often prescribed for the treatment of CA-S. aureus SSTI. Current IDSA CA-MRSA guidelines~     suggest that incision and drainage alone may be adequate for management of uncomplicated~     CA-S. aureus skin abscesses and there is uncertainty about the need of antibiotics. It is not~     known whether antibiotics are helpful in decreasing S. aureus colonization rates or~     preventing future S. aureus infections. Though resolution of acute abscess after drainage may~     be unchanged by antibiotic administration, the impact of managing S. aureus abscess without~     antibiotics on ongoing S. aureus colonization and recurrent infection requires further study.~     This study seeks to examine whether the management of initial S. aureus abscesses with~     incision and drainage in addition to antibiotic therapy is an effective means of preventing~     recurrent infection. The prolonged longitudinal follow-up of this study is another unique~     characteristic that will enable the investigators to capture data about recurrences of~     infections.~   "
66967|NCT02690402|"~     Older people are a very heterogeneous population characterized by a high interindividual~     variability. Functional abilities (walking, transfers ...) used to classify individuals aged~     (Lalive d'épinay et al., 1999) in three categories: independent, frail and dependent (HAS,~     2005). Frailty is generally considered as a state that precedes dependent status and, unlike~     the latter, is still reversible (Fried et al., 2001). Now, it's necessary to understand and~     quantify the indicators above the dependence of the elderly from a multidisciplinary approach~     to frailty, is a critical public health issue for developing non-drug therapeutic~     interventions adapted to delay the institutionalization. Through this study, it is to~     identify risk and protective factors of frailty and their relationships with physical~     activity, evaluate them and propose an appropriate care to the patient. This study should~     enable the production of new scientific knowledge to improve the health and quality of life~     of older people.~   "
66968|NCT02690389|"~     Object: To explore the mechanism of the electro-acupuncture (EA) induced sedation effect in~     general anaesthesia through investigating the role of the Benzodiazepines-GABA system.~      Method: 80 patients undergoing abdominal surgery were randomly divided into four groups~     (n=20): C group (propofol only group), F group (propofol + flumazenil group), EA group~     (propofol + electro-acupuncture group), and EA+F group (propofol + electro-acupuncture +~     flumazenil group). Before induction, acupuncture needles were inserted at the points of~     Zusanli (ST 36) and Neiguan (PC 6) bilaterally to elicitDeQi. Target-controlled infusion~     (TCI) of propofol was used for the induction and maintenance of anaesthesia. After 15minutes,~     equilibrium of Narcotrend Index (NT index) was achieved, patients were then assigned to~     receive different interventions. In EA group and EA+F group, patients received EA for 30~     minutes under general anaesthesia, and flumazenil with the dosage of 0.1mg/kg was added in~     the latter at the end of EA. In C group and F group, patients didn't receive EA, and~     flumazenil with the dosage of 0.1mg/kg was administered in F Group at the same time point~     with EA+F group. HR, MAP and NT index were recorded at different time points up to 30 minutes~     after the end of EA.~   "
66969|NCT02690376|"~     Gastroscopy (OGD) is a useful test for investigating a variety of suspected upper GI~     disorders. But it is uncomfortable for patients and incurs the risk of intubation and~     sedation, plus a large proportion of procedures reveal insignificant or no pathology. Capsule~     endoscopy (CE) is the investigation of choice for diseases of the small bowel. It is safe,~     non-invasive and well-tolerated. The use of CE is traditionally restricted to the small~     bowel, although newer capsules to image the oesophagus and colon are currently in use.~     Previous capsules have failed to adequately image the stomach due to its' large volume and~     rugal folds. Recently a magnetic capsule and handheld magnet has been developed (Mirocam~     Navi, Intromedic Ltd, Seoul, Korea) to enable an element of manoeuvrability of the capsule.~     This is unnecessary in the small bowel where the capsule is propelled along its' tubular~     structure by peristalsis, but in the capacious stomach this may allow the capsule to be~     steered to examine all areas of the stomach. We have already conducted two feasibility~     studies in porcine models with promising results and a trial has already evaluated the~     equipment to steer the small bowel capsule through the stomach into the duodenum. An ongoing~     study is comparing the ability of this technique to examine the stomach against conventional~     OGD, in patients with recurrent iron deficiency anaemia. The next stop would be to compare~     the two modalities under other different conditions.~      We wish to undertake a prospective single blind controlled trial comparing magnetically~     assisted capsule examination to conventional OGD in diagnosing upper gastrointestinal~     pathology in patients with gastrointestinal bleeding.~   "
66970|NCT02690350|"~     The main objectives of the trial are:~        -  To evaluate the safety and tolerability of U3-1784 in patients with advanced solid~          tumours~        -  To determine the maximum tolerated dose (MTD) and or establish the safety and~          tolerability of the maximum administered dose (MAD) of U3-1784~   "
66971|NCT02690337|"~     This is an open-label study to evaluate the safety, tolerability, and pharmacokinetics of~     DS-1123a in Japanese subjects with advanced solid tumors.~   "
66972|NCT02690324|"~     development of skin adhesive patches for the monitoring and prediction of mental disorders~   "
66973|NCT02690311|"~     Effects of Smartphone Use at Night with Light Emitting Diode Display With and Without Blue~     Light in Healthy Adults: A Randomized, Double-blind, Cross-over, Placebo-controlled~     Comparison~   "
66974|NCT02690298|"~     Previous studies have shown that the ExSpiron™ can provide non-invasive, real-time, accurate~     measurements of minute ventilation (MV), tidal volume (TV) and respiratory rate (RR) after~     calibration with a spirometer. The purpose of this study is to compare the MV, TV and RR~     values measured by the ExSpiron™ without prior spirometer calibration to values obtained with~     a spirometer calibration. In this study, the MV and TV values will be compared between the~     ExSpiron™ with and without prior patient-specific calibration of the ExSpiron™ to a~     spirometer~   "
66975|NCT02690285|"~     The purpose of this study is to identify and analyze the frequency of GSTZ1 haplotypes in a~     healthy adult population and determine the pharmacokinetics of Dichloroacetate (DCA)~     metabolism based on haplotype analysis.~      The DCA drug is the first targeted treatment for Pyruvate Dehydrogenase Complex Deficiency~     (PDCD).~      This pilot study, focuses on developing a high throughput, sensitive and accurate screening~     test for determining glutathione transferase zeta 1 (GSTZ1) haplotype status in individuals~     who would be treated with DCA.~   "
66976|NCT02690272|"~     The kidney transplant remains the privileged treatment of the terminal renal insufficiency.~     This care is complex for the patient both on a medical surgical plan and by the psychic~     reorganizations. Among the temporary contraindications of transplantation, us retrouvonsdes~     psychological reasons. The research work consists in highlighting the psychic mechanisms of~     the subjects awaiting kidney transplant.~   "
66992|NCT02690064|"~     Cystic fibrosis has many health consequences. A reduction in the ability to perform exercise~     in patients with CF is related to greater death rates, steeper decline in lung function, and~     more frequent lung infections. However, the physiological mechanisms for this reduced~     exercise capacity are unknown. The investigators recently published the first evidence of~     systemic vascular dysfunction in patients with CF. Therefore, it is reasonable to suspect~     that the blood vessels are involved with exercise intolerance in CF. This study will look at~     how and if oxidative stress contributes to both artery dysfunction and exercise intolerance~     in CF.~   "
66977|NCT02690259|"~     In endometrial cancer (EC) pelvic and paraaortic lymphadenectomy is performed only in high~     risk groups (with approximately 20% of patients having lymph node metastases (LNM)) whereas~     no lymphadenectomy is recommended in low risk groups despite 5% LNM. Moreover, preoperative~     risk group allocation is known to be erroneous in up to 15% of patients.~      A technique identifying sentinel lymph nodes (SLN) in endometrial cancer have the potential~     to spare extensive surgery in 80% of high risk patients, identify low risk patients with~     nodal metastases, diminish side effects caused by full lymphadenectomy and render some~     expensive preoperative risk group allocation measures unnecessary.~      A clinically useful SLN technique requires a high technical success rate, a clear definition~     of SLN, an algorithm taking into account that metastatic nodes not always accumulate tracer~     and a reproducible surgical algorithm. A definition of SLN requires knowledge on lymphatic~     anatomy. Unfortunately all tracers, dyes/radiotracers often result in an abundance of~     colored/ signaling nodes. Therefore, a definition of a SLN requires identification of~     efferent/afferent lymph vessels.~      Several publications describe sentinel node techniques in EC with a variety of tracers~     (various dyes, radiotracer, alone or in combination). Sentinel nodes are usually described as~     radioactive nodes or colored nodes only with no further discrimination. No study relate~     to an anatomical description of lymphatic pathways.~      The aims of this study is to systematically display the major anatomical pathways with the~     use of ICG and to evaluate a standardized and reproducible SLN surgical algorithm based on~     lymphatic anatomy and identification of efferent lymph vessels.~   "
66978|NCT02690246|"~     Hereditary haemorrhagic telangiectasia (HHT), also known as Rendu-Osler-Weber syndrome, is an~     inherited multisystemic disorder with recurrent epistaxis, mucocutaneous telangiectasia and~     visceral arteriovenous malformations. The purpose of this study is to provide data about~     multiple clinical aspects of HHT and responses to treatment. For comparison of some aspects~     also data of non-affected relatives is collected (second cohort). the questionnaire has been~     designed primarily for web based entry, but can also be circulated in paper format on~     request.~   "
66979|NCT02690233|"~     This study on minor surgery serves to explore whether a dose-response relationship exists~     between surgical stress and endothelial dysfunction in the early postoperative period. The~     aim of this explorative and observational clinical study is to closely examine the~     endothelial function and its dynamics in the early postoperative period after minor surgery~     (lap. inguinal hernia repair). The endothelial function will be assessed indirectly by~     EndoPat and plasma biomarkers of nitric oxide bioavailability. The study will contribute to~     the understanding of perioperative myocardial injury, which is crucial for optimized~     treatment of patients at risk of cardiovascular complications.~   "
66980|NCT02690220|"~     The purpose of this study is to determine the influence of anterior pelvic prolapse~     reconstruction with a titanized polypropylene mesh on patients quality of life.~   "
66981|NCT02690207|"~     The purpose of this study is to cross-vaccinate and collect safety data in terms of~     unsolicited Adverse Events (AEs), Serious Adverse Events (SAEs) and potential Immune Mediated~     Disease (pIMD) from subjects >= 50 Years of age (YOA) who previously received placebo in~     ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229).~   "
66982|NCT02690194|"~     The primary aim is to investigate the efficacy of Buddhify relaxation therapy in reducing the~     stress and anxiety levels of patients. The secondary aim is to investigate the effect of~     prior stress and anxiety levels on the perceived pain level of undergoing a medical~     procedure, reported post-procedure.~   "
66983|NCT02690181|"~     The objective of this extension study is the initial assessment of safety and immunogenicity~     of the second dose of GBS Trivalent Vaccine following the time interval that is close to the~     inter-pregnancy interval observed in the general population.~   "
66984|NCT02690168|"~     Hypoglycemia-associated autonomic failure (HAAF), a condition commonly developed in diabetic~     patients, which causes them to have severely low blood sugar levels. This condition makes~     clinical management of blood sugar in diabetic patients very challenging. This research seeks~     to better understand how diabetic patients develop HAAF, and what can be done to prevent it.~   "
66985|NCT02690155|"~     To obtain a better understanding on the comparative effectiveness of rivaroxaban versus~     VKA(Vitamin K antagonist) for stroke prevention in patients with NVAF(non-valvular atrial~     fibrillation) in a real-life setting~   "
66986|NCT02690142|"~     The purpose of this first-in-human study is to investigate the safety and tolerability of~     ABY-035 when administered intravenously and subcutaneously, to healthy volunteers and to~     psoriasis patients.~   "
66987|NCT02690129|"~     The purpose of the study is to assess the efficacy of vaginal micronized progesterone in the~     treatment of threatened miscarriage. All eligible pregnant women will be randomized to either~     receive vaginal progesterone or no treatment.Evaluation will be two weeks after intervention,~     then every 4 weeks up to 28 weeks gestation or termination of pregnancy.~   "
66988|NCT02690116|"~     The purpose of this study is to test whether Meditative Movement (based on a standardized and~     tested Qigong/Tai Chi Easy protocol) is more efficacious for improving fatigue and other~     symptoms in women after treatment for breast cancer than (a) a non-meditative sham Qigong~     active intervention and (b) an inactive education / support group.~   "
66989|NCT02690103|"~     Current treatments for Hepatitis C virus (HCV) have severe side effects and are very~     expensive. There is a need to explore effective natural therapies against HCV that are less~     toxic and more cost-effective.~      37 chronic HCV infected patients were randomized into two groups and treated with PEG~     interferon plus ribavirin for the first group or Biobran, an arabinoxylan from rice bran (1~     g/day) for the second group. Viremia level, liver enzymes, γ-interferon (IFN-γ) levels in~     serum, and toxicity were checked before and three months after treatment.~   "
66990|NCT02690090|"~     The investigators study is the first step (a pilot study) in determining whether the~     manufacturer's recommended dose of a blood thinner called enoxaparin, in adults who are~     patients in an intensive care unit and have severely reduced kidney function (less than or~     equal to approximately 30% of their normal function) is safe with respect to the adverse~     effect of bleeding.~      The investigators hypothesis is that studying these patients, going forward in time, without~     interfering with their care, to eventually determine if this blood thinner is safe at reduced~     doses, is feasible.~   "
66993|NCT02690051|"~     A Physician initiated PMCF Trial Investigating the BeSmooth Peripheral Stent System for the~     treatment of Iliac Lesions.~      The objective of this clinical investigation is to evaluate the long-term safety and efficacy~     of the BeSmooth Peripheral Stent System in clinical settings post CE-certification when used~     according to the indications of the IFU.~   "
66994|NCT02690038|"~     This study will look at immunoglobulin (Ig) treatment in hospitalized chronic obstructive~     lung disease (COPD) patients with frequent exacerbations.~      This is a Phase II, pilot randomized double blind control study, meaning this study will help~     assess if this research can be expanded to evaluate Ig treatment in patients with COPD. Ig~     treatment is a sterile solution of human immunoglobulin proteins given intravenously (in the~     vein). Immunoglobulins are part of the immune system and help the body fight infections.~     Participants will be assigned to either receiving the Ig treatment or normal saline as a~     control product every 4 weeks for 12 months.~      Participants will continue on current standard therapy as determined by their treating~     physician.~   "
66995|NCT02690025|"~     A proof-of-concept, dose finding, controlled, single-center, randomized, double-blind, fixed~     dose phase 2 trial with ZP1848 in patients with Short Bowel Syndrome.~   "
66996|NCT02690012|"~     Hypomagnesemia (hMg) is a common side effect of important anti-cancer therapies such as~     epidermal growth factor receptor inhibitors (EGFRIs) and platinum-containing anti-cancer~     drugs. EGFRIs, including cetuximab (cmab) and panitumumab (pmab), have been estimated to~     cause hMg in over 18% and 27% of patients respectively1, while 90% of patients receiving~     cisplatin will develop hMg if left untreated. The development of severe hMg may result in~     increased symptoms such as fatigue, neuromuscular changes, mental status changes and cardiac~     arrhythmias which could result in treatment delays and may compromise treatment efficacy.~     Despite the common occurrence of this toxicity, little is known regarding the optimal~     magnesium management strategy. As physicians do not know what the best treatment for~     patients is, genuine uncertainty (clinical equipoise) exists. Physicians will choose~     between different standards of magnesium replacement in their personal practice, using~     idiosyncratic decision making processes, without the physician or the patient knowing the~     optimal option. This is not good for patients, physicians and society as a whole. Determining~     the optimal treatment remains an important medical issue for patients, physicians and~     society. This study will use a novel method to allow comparisons of established standard of~     care prophylactic treatment using the integrated consent model as part of a pragmatic~     clinical trial7. By integrating medical and clinical practices, physicians will be able to~     inform their patients about the randomized control trial, akin to a typical conversation~     between the physician and patient, without written informed consent. This clinical~     interaction would then be documented, as ordinarily done in practice. Medical and clinical~     practice will be intertwined with the patients' welfare at the forefront of our best~     interests.~   "
66997|NCT02689999|"~     It is planned to investigate the effect of dexrabeprazole on gastric acid primarily, and then~     gastroesophageal reflux disease (GERD) symptoms, intraesophageal acidity (reflux) and~     impedance kinetics.~   "
66998|NCT02689986|"~     Prospective, non-randomized multicenter study on the safety and efficacy of combination~     therapy with bendamustine and rituximab for chronic cold agglutinin disease.~   "
66999|NCT02689973|"~     This longitudinal experimental study tested the effects of three brief interventions: (1)~     prompting the formation of plans (or implementation intentions), (2) prompting self-efficacy~     beliefs, and (3) prompting planning + self-efficacy in adolescents aged 14-18 years relative~     to an active 'education only' control group.~      It was hypothesized that participants assigned to the interventions would exhibit a smaller~     increase in body fat at 14-month follow-up compared to controls. The study also investigated~     whether the combined planning + self-efficacy intervention would have larger effects on the~     main outcome (body fat) than single-component interventions. Second, it was hypothesized that~     the effects of the intervention conditions on body fat at 14-month follow-up would be~     mediated by their respective psychological and behavioral constructs: self-efficacy and~     planning at T2 (Mediator 1), and by moderate-to-vigorous physical activity (MVPA) at T3~     (Mediator 2). It was expected that the effects of the interventions including the planning~     component (i.e., planning intervention and self-efficacy + planning intervention) would be~     mediated by respective cognitions, i.e. planning, whereas the effects of the interventions~     including self-efficacy component (i.e., self-efficacy intervention and self-efficacy +~     planning intervention) would be mediated by self-efficacy. Finally, it was explored whether~     the effects of the intervention (both direct and indirect effects, via their respective~     psychological variables and MVPA) on body fat would be moderated by the presence of built PA~     facilities, located in the proximity of schools.~   "
67000|NCT02689960|"~     Patients with chronic adrenal insufficiency need to adapt their glucocorticoid replacement~     dose in conditions of physical or psychological stress to prevent life threatening adrenal~     crisis. In cases of more severe impairment or unsecure gastrointestinal absorption (e.g.~     gastroenteritis, severe infectious disease), rapid and highly dosed administration of~     glucocorticoids is crucial. The study is conducted to offer female patients the possibility~     to perform efficient prednisone self-administration in emergency situations in a way of~     administration, which is easy to perform and accepted by the patients. Therefore,~     pharmacokinetics and safety of vaginal prednisone administration will be studied and compared~     to rectal administration.~   "
67001|NCT02689947|"~     Prospective single center study to evaluate the safety and effectiveness of Restylane Silk~     for treatment of tear trough correction.~   "
67002|NCT02689934|"~     A randomized, double-blind, placebo-controlled, parallel study to evaluate the efficacy of a~     red yeast rice based nutraceutical (monacolin K 10 mg/dose) plus probiotic (Bifidobacterium~     longum BB536 ®), versus placebo, in patients with moderate hypercholesterolemia, in terms of~     improvement of the lipid profile and cardiovascular risk.~   "
67003|NCT02689921|"~     This is a prospective, single-arm, phase II study of 32 evaluable patients treated with~     NEOADjuvant Aromatase inhibitor and Pertuzumab/Trastuzumab (NEOADAPT) without chemotherapy~     for hormone receptor positive (HR+), [i.e. Estrogen Receptor positive (ER+) and/or~     Progesterone Receptor positive (PR+)] HER2+ localized, non-metastatic stage I - IIb breast~     cancer.~   "
67004|NCT02689908|"~     The adjustment of radiation dose in many CT protocol are based on body mass index(BMI) or~     weight of the patient.~      In the literature, neck circumference (NC) has been reported as a new anthropometric~     parameter indicating the body mass for the upper body.~      NC may be an important landmark in the determination of the low dose protocols for upper body~     CT examinations such as neck, chest and coronary CT.~   "
67148|NCT02688023|"~     Colorectal cancer is an aggressive malignancy with a poor overall outcome. The purpose of~     this study is to evaluate the feasibility, safety and efficacy of neoadjuvant oxaliplatin,~     irinotecan combined with 5-fluorouraci/leucovorin or S-1 or capecitabine in patients with~     resectable colorectal cancer.~   "
67005|NCT02689895|"~     Highly active antiretroviral therapy (HAART) transformed a once fatal condition into a~     chronic, manageable condition. However, it is estimated that 20-40% of patients on 2nd line~     treatment (2 nucleotide reverse transcriptase inhibitors [NRTIs] and a boosted protease~     inhibitor [PI]) are failing treatment. Figures are thought to be higher in children and~     adolescents.~      The reason why patients are failing 2nd line treatment is not exactly known. Failure has been~     previously attributed to poor adherence. However, some literature shows that some patients on~     boosted PIs achieve and maintain viral suppression despite suboptimal adherence (adherence of~     80- 95%). Viral factors, like drug resistance, are also implicated in treatment failure.~     However, boosted PIs have high genetic barrier to clinically significant mutations.~     Therefore, a virus would have to harbour multiple PI mutations for the virus to have reduced~     susceptibility to boosted PI regimens. Pharmacological factors such as suboptimal dosing,~     impaired absorption and drug interactions may also be responsible for treatment failure.~      If sub-optimal adherence is the reason why children are failing 2nd line treatment, then~     restoring optimal adherence should result in viral suppression, failure of which might mean~     that other causes are contributing to failure. If resistance is the cause of treatment~     failure, then this study will provide evidence for advocating for resistance testing and the~     use of 3rd line antiretroviral drugs. If children with adequate adherence demonstrate~     inadequate drug levels in their plasma, then this study will provide evidence to advocate for~     studies to examine reasons for inadequate drug exposure amongst HIV-infected children. These~     studies are paramount to optimizing dosing algorithms in this population.~      This proposed study will help elucidate reasons for treatment failure in HIV-infected~     children on second line treatment with the aim of ultimately optimizing antiretroviral~     treatment strategies for this important group.~   "
67006|NCT02689882|"~     Nicotinamide riboside (NR) has been available over the counter as a nutraceutical (Niagen®,~     ChromaDex, Inc.) since the summer of 2013. However, classical pharmacokinetic (PK) data for~     NR have not been reported in humans. This study will use a recently-developed, whole blood~     assay for NR to assess the pharmacokinetics of NR at a maximum dose of 1000 mg twice daily,~     and will collect history, physical examination and laboratory data to determine the safety~     and tolerability of NR in eight, healthy volunteers. In addition, whole blood nicotinamide~     adenine dinucleotide (NAD) levels will be measured at each time point, to determine whether~     this NR dose significantly raises whole blood NAD levels.~   "
67007|NCT02689869|"~     Primary Objectives The primary objective of this study is to evaluate the efficacy of the~     chemotherapy-free combination of ibrutinib and obinutuzumab (GA 101) in patients with~     previously untreated follicular lymphoma (FL) and a high tumor burden. Primary endpoint to be~     observed for this is the rate of progression free survival one year after start of therapy.~      Hypothesis The hypothesis of the study is that ibrutinib in combination with obinutuzumab~     will achieve response rates (CR and PR), rates of MRD negativity and PFS which are comparable~     to currently used standard rituximab-chemotherapy combinations such as R-CHOP or~     R-bendamustine in subjects with previously untreated FL and a high tumor burden.~   "
67008|NCT02689856|"~     The objectives of this study are to assess the potential contribution of lidocaine~     hydrochloride or hydrocortisone acetate, alone or in combination, in topical cream~     preparations in the treatment of Grade I or II hemorrhoids and to demonstrate the safety and~     efficacy of the test articles when applied twice daily for 14 days in subjects with Grade I~     or II hemorrhoids. These products reflect common drug combinations of lidocaine hydrochloride~     or hydrocortisone acetate found in many prescription hemorrhoid products.~   "
67009|NCT02689843|"~     The aim of this study is to evaluate the effects of three-month course of treatment~     modalities (Cyproterone compound-Spironolactone, Metformin and Pioglitazone) in patients with~     polycystic ovary syndrome (PCOS) on markers of inflammation [serum complement, homocysteine~     and high sensitive C-reactive protein (hs-CRP)] levels.~   "
67010|NCT02689830|"~     The purpose of this study is to assess the feasibility and safety of Prostate Artery~     Embolization (PAE) in patients suffering of Acute Urinary Retention (AUR) in the context~     Benign Prostatic Hypertrophy (BPH).~   "
67011|NCT02689817|"~     Hospital-acquired pressure ulcers (HAPUs) are a well-established serious complication of~     hospitalization that have serious consequences on patient morbidity and mortality as well as~     the cost of care. At the core of the problem for patient-centered targeted prevention of~     HAPUs is the lack of knowledge surrounding the magnitude and duration of pressure necessary~     to cause pressure ulcers, and the lack of immediate feedback on whether these interventions~     do anything to substantially offload at risk areas. Previous studies have been inconsistent~     in their findings of an association between duration of time and HAPU occurrence. While~     retrospectively this has been investigated, there is currently no substantial prospective,~     randomized study.~      This study seeks to better understand the interface pressures between the patient and his or~     her support surface and how this relates to the development of pressure ulcers. The effect of~     patient characteristics and the relationship between total length of time on the operating~     table and pressure ulcer development will also be assessed.~      The findings from this study will significantly add to strengthening the body of evidence~     regarding pressure ulcer development, specifically the relationship between the magnitude of~     interface pressure between the patient and the support surface for what duration of time~     leads to the development of a pressure ulcer. The results will provide critical insight into~     the physiologic targets healthcare providers should use to develop better pressure ulcer~     prevention programs, which could ultimately lead to a reduction in the incidence of pressure~     ulcers.~   "
67012|NCT02689804|"~     A well-designed pharmacokinetics (PK) study may identify the physiologic basis for observed~     differences in levonorgestrel emergency contraception (LNG-EC) and ulipristal acetate~     emergency contraception (UPA-EC) failure rates in women with normal and obese BMI. The~     investigators propose a study to compare serum LNG and UPA levels after administration of a~     single-dose of LNG-EC or UPA-EC. The investigators hypothesize that there will be no~     difference in PK parameters between women with normal BMI and obese women.~   "
67013|NCT02689791|"~     A randomized, single-blind, cross-over study was conducted to determine the effect of~     replacing standard wheat flour (SWF) with resistant wheat starch (RWS) on markers of appetite~     and food intake in healthy adults.~   "
67054|NCT02689245|"~     Data for stool microbiome will be collected for all the chronic hepatitis B subjects (pre~     cirrhotic,compensated,decompensated and reactivation). All the in and out patient with~     Hepatitis B reactivation will be recruited and randomized into two arms.~      Group 1 Tenofovir Group 2 Tenofovir with FMT (Fecal Microbiota Transplant).~      Tenofovir would be given 300 mg once daily FMT through NJ (Naso-Jejunal) tube for 7 days.~   "
67055|NCT02689232|"~     All patients with non variceal bleed who are admitted under the Department of Hepatology at~     Institute of Liver and Biliary Sciences, who meet the inclusion criteria and who provide~     informed consent.~   "
67056|NCT02689219|"~     This is a Phase II study to evaluate the activity of brentuximab vedotin in~     relapsed/refractory non-seminomatous germ cell tumors (NSGCT).~   "
67014|NCT02689778|"~     It is estimated that approximately 30% of patients with diabetes develop diabetic~     nephropathy. Diabetic nephropathy is a multifactorial progressive disease that occurs through~     various mechanisms such as hyperglycemia, oxidative stress, inflammation and fibrosis,~     control or blocking these mechanisms are therefore potential therapeutical targets for this~     entity. Current treatment options are based on the glycemic control, blood pressure control,~     as well as the use of medications such as angiotensin-converting enzyme inhibitors and~     Angiotensin II receptor antagonists, these actions are not enough to stop progression.~     Pirfenidone is a drug with antifibrotic, antioxidant, and anti-inflammatory properties.~     Although the specific mechanism is unknown, pirfenidone interferes with the expression,~     secretion and the effect of the β (TGF-β) transforming growth factor. The investigators plan~     to carry out a controlled clinical study to evaluate the effect of pirfenidone in patients~     with type 2 diabetes and nephropathy. The period of time the treatment will be administered~     will be of 12 months, 62 patients will be included. The primary outcome will be improvement~     in glomerular filtration rate. The secondary outcomes will be number of patients requiring~     replacement therapy, 24 hour urine microalbuminuria and change in the concentration of TGF -~     β. Change in these parameters will be evaluated at the end of the treatment period (12~     months). Throughout the study the incidence of adverse events will be recorded, wich will~     allow us to learn about the safety and security of the drug in this population.~   "
67015|NCT02689765|"~     Metabolic problems represent one of the major health concerns which are attractive for being~     addressed by nutritional interventions, as these are directly connected to dietary~     habits.Anthocyans possess cardiovascular disease prevention, obesity control, and diabetes~     alleviation properties, but association between anthocyans and prediabetes need to be more~     firmly understood and established from robust clinical data. However, there is little human~     research that has reported on the efficacy of increased anthocyans bioactive consumption on~     insulin sensitivity in pre-diabetes.~   "
67016|NCT02689752|"~     This will be an open-label, single-center study to evaluate pharmacokinetics and safety of~     HMPL-013 in approximately 6 healthy male subjects receiving a single oral 5mg dose of~     HMPL-013 containing approximately 100 microcuries of [14C] HMPL-013. This study will~     investigate the absorption, drug biotransformation and mass balance of HMPL-013, seek to~     identify the compound's major metabolites and supply information for clinical application.~   "
67017|NCT02689739|"~     This is a prospective observational study comparing venous Doppler flow in the lower~     extremities of pregnant women. Pregnant women with a BMI >/= 30 will be compared to those~     with a BMI < 30.~   "
67018|NCT02689726|"~     A Phase 1, Open-Label Study to Evaluate the Safety, Tolerability, and Immunogenicity of~     GTL001 Vaccine Adjuvanted With Imiquimod Cream in HPV 16- and/or HPV 18-Infected Women Aged~     25 to 65 Years, With Normal Cytology, ASCUS, or LSIL.~   "
67019|NCT02689713|"~     This study seeks to test if the study drug (voriconazole), when applied topically to a burn~     wound on the skin will help to reduce pain.~   "
67020|NCT02689700|"~     The aim of the study is to determine the total concentration of HCMV- and VZV-specific~     IgG-antibodies and the total concentration of neutralizing antibodies against HCMV in~     neonatal bloodstream depending on gestational age at birth.~   "
67021|NCT02689687|"~     This study offers remote monitoring devices for weight and medication adherence, combined~     with behavioral economic approaches, to patients with congestive heart failure (CHF). This~     pilot study aims to evaluate the feasibility of enrollment processes and intervention~     roll-out to inform a randomized controlled trial, to estimate the readmission rate of~     participants, and to assess if and how managing clinicians respond to weight gain alerts~     entered into a participant's electronic medical record.~   "
67022|NCT02689661|"~     The primary purpose of this study is to discover modifiable risk factors for the development~     of neuropathy, specifically looking at the metabolic syndrome.~   "
67023|NCT02689648|"~     Long term prognosis and risk factors in functional gastrointestinal disorder (FGID) is~     largely unknown. The investigators plan to retrospectively analyse a cohort of children who~     were referred to the Pediatric Clinic due to abdominal pain with the aims to learn more about~     symptoms and effects of investigations performed. Furthermore, the investigators plan to~     contact the cases for a follow up using a validated questionnaire and analyse the long term~     prognosis and risk factors for prolonged severe symptoms.~   "
67024|NCT02689635|"~     Patients over 18 years of age, admitted to the hospital with HF exacerbation, will be~     eligible for randomization to low salt or regular diet. Laboratory tests are routinely~     obtained on admission and on the day (or the day before) of discharge (comprehensive~     metabolic panel and NT-proBNP) and will be recorded for the study. Daily weights are~     routinely recorded, and intake/output will be monitored. At discharge, a Diet Acceptability~     Questionnaire will be performed.~      After the discharge, participants will return for follow-up visits as needed for clinical~     indications. Our study coordinator will document changes of symptoms, changes in therapies,~     and capture clinical events like unscheduled hospital visits or visits to the Emergency Room.~     Once during the study patients will be asked about their specific food consumption on a prior~     day, and the Sodium content will be estimated. The final visit will occur in a year~     (approximately 11-13 months after enrollment). Weight, other vital signs, CMP, BNP, and Diet~     Acceptability Questionnaire quality of life questionnaire will be collected at this point, if~     clinically indicated.~      The majority of study information will be collected from routine care for standard clinical~     indications. The only components added for study purpose are Diet Acceptability Questionnaire~     and collection of the information on consumed foods.~   "
67057|NCT02689206|"~     GSK1278863 is an orally available, hypoxia-inducible factor - prolyl hydroxylase inhibitor,~     currently being investigated as a treatment for anemia associated with chronic kidney~     disease. GSK1278863 has been given as a once daily regimen in clinical studies to date.~     However, physicians in countries that use a three-times weekly hemodialysis schedule prefer~     to give the anemia medicine at the same time as the dialysis session. This study will test~     how well GSK1278863 can maintain hemoglobin levels when given three-times weekly, for 29~     days.~      This study will describe the relationship between hemoglobin and GSK1278863 given three-times~     weekly. The data from this study will allow for conversion of once daily doses to three-times~     weekly doses.~   "
85796|NCT02444039|"~     The objective of the study is to compare the ease of use and performance of the SL-D301 with~     the DC-4 with other existing slit lamps imaging systems (SL-3G) from Topcon.~   "
67025|NCT02689622|"~     No prospective study was conducted in elderly patients with cancer to assess the relative~     value of disease-related and patient-related prognosis factors. Patient-related prognostic~     factors have been highlighted in elderly patients with cancer resulting in the necessity of a~     geriatric assessment. The impact on overall survival of all of these factors was recognized~     in elderly people with cancer but remains unknown in High Risk Myelodysplastic Syndromes~     (HR-MDS). Therefore this information could be crucial to better select geriatric assessment~     domains relevant for the prediction and to recommend simplified tool after stratification of~     geriatric assessment domains thanks to their predictive value.~      The main hypothesis is that patient-related factors will have a better capacity to predict~     survival and treatment tolerance than disease-related factors in HR-MDS aged 75 and over and~     that the predictive value will be different among assessment tools which allows a selection~     of reduced number of tools for clinical use.~      To best knowledge estimation of predictive value of geriatric assessment tools remains~     unknown and explains why no standardization of practice exists. In testing all tools at the~     same cohort of patients allows to compare different tools and to define minimal and optimal~     geriatric assessment for HR-MDS. To determine the best strategy of geriatric assessment will~     allow in a second time to measure the impact of the use of this geriatric standardized~     evaluation by comparing patients'care and prognosis according to the use or not by the~     doctors of the new scores.~      Research outcomes are various medical, economic and ethic. Medical because decision-making~     will be improved with simplified geriatric assessment; economic because a better knowledge of~     geriatric assessment will improve treatment toxicity prevention and decrease treatment costs.~     Ethic will be associated with this project because a better knowledge of geriatric assessment~     tools to predict survival and tolerance treatment could improve the choice of best supportive~     care if prognosis markers are not favorable to active therapy. This project could induce~     important modification of practice in this area to an improved personalized treatment and~     simplification of geriatric assessment allowing a large diffusion in hospitals and clinics.~   "
67026|NCT02689609|"~     The investigators evaluate if there are radiation dosimetric parameters for the prediction of~     biochemical and clinical hypothyroidism after intensity-modulated radiation therapy (IMRT)~     for non-metastatic nasopharyngeal carcinoma (NPC).~   "
67027|NCT02689596|"~     The goal of the study is to investigate the effects of intranasal oxytocin (OT) or placebo to~     resting state brain activity in healthy males.~   "
67028|NCT02689583|"~     Since the discovery of Helicobacter pylori (H. pylori), many studies have been carried out~     with the goal of improving H. pylori eradication and therapies have changed from~     single-antibiotic treatments to the current multi-antibiotic treatments. However, the~     eradication rate of H. pylori is still less than 80%. The reasons for this low eradication~     rate are likely to be multi-factorial, including the reduced activity of antimicrobial drugs,~     poor patient compliance or micro-environment in stomach. In this study, to obtain the higher~     eradication of H. pylori and discover the different mechanism between the current infection~     and refractory infection of H. pylori, it is necessary to perform a prevalence survey for~     eradication of H. pylori based on the results from isolation of H. pylori strains, antibiotic~     susceptibility testing, CYP2C19 gene polymorphism, drug resistance gene sequencing and~     16SrRNA sequencing.~   "
67029|NCT02689570|"~     Objective: To investigate whether visceral adipose tissue (VAT) and its adipokines contribute~     to early signs of cardiovascular disease, meaning coronary artery calcifications (CAC) and~     diastolic dysfunction in type 1 diabetes (T1DM).~      Research Design & Methods: A cross-sectional study of T1DM patients without a history of~     cardiovascular disease. CAC and VAT are measured using a CT scan. CAC is scored using the~     Agatston method. Echocardiography is performed to assess contractile abnormalities. Serum~     levels of adipocytokines (adiponectin, leptin, IL-6 and TNF-a) are measured using ELISA~     assays.~   "
67030|NCT02689557|"~     Successfully develop and confirm with the Higher School of Electronics West Plethysmographic~     a multichannel recorder to perform measurements staggered volume of the lower limbs at rest,~     walking and recovery (6 storied measures on members lower).~   "
67031|NCT02689544|"~     The purpose of this study is analyze the effects, acute and chronic, static and dynamic~     stretching on flexibility and neuromuscular and functional performance in active, healthy~     individuals.~      Study hypothesis:~        1. Static stretching program improves flexibility and reduces neuromuscular and functional~          performance in active, healthy individuals.~        2. Static stretching program improves flexibility and neuromuscular and functional~          performance in active, healthy individuals.~   "
67032|NCT02689531|"~     The purpose of this study is to better define the intensive care unit population at highest~     risk for developing Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia~     (HABP/VABP).~   "
67033|NCT02689518|"~     Clinical and genetic evaluation of individuals treated with intravitreal aflibercept~     injection (Eylea) for neovascular age-related macular degeneration (wet AMD)~   "
67034|NCT02689505|"~     This is a Phase I, multi-centre, non-randomized, uncontrolled, open-label, dose escalating~     study of BI 836880 administered intravenously once a week. The eligible patient population~     will be patients with advanced solid tumors.~      The primary objective of this trial is to determine the maximum tolerated dose (MTD) and~     recommended Phase II doses for BI 836880 in patients with solid tumors. Preliminary safety~     data will be evaluated as secondary objectives.~      Subsequently, pharmacokinetic profile, pharmacodynamic changes in circulating biomarkers and~     Dynamic Contrast-Enhanced Magnetic Resonance Imaging ( DCE-MRI), anti-tumor activity and the~     immunogenicity of BI 836880 will be explored up to a total of 40 patients with advanced solid~     tumors.~      Dose escalation will be guided by a Bayesian logistic regression model with over dose control~     (EWOC) using at least 2 patients per dose cohorts.~      Safety criteria will be followed, including adverse events according to Common Terminology~     Criteria (CTCAE version 4.03), incidence of dose limiting toxicities, physical examination,~     vital signs, safety laboratory parameters and Eastern Cooperative Oncology Group (ECOG).~   "
67035|NCT02689492|"~     The present study will explore the patients satisfaction to COPD medical treatment (i.e.~     pharmacological and not pharmacological treatment) in a clinical real-world setting and how~     the satisfaction for medical treatment is related to clinical parameters, quality of life,~     illness perception and treatment adherence evolution.~      Moreover health care resource consumption will be observed during the observation period.~   "
67036|NCT02689479|"~     In people with type I diabetes, the insulin producing cells in the pancreas have been~     destroyed. Presently one can only evaluate the function of the graft through laboratory~     tests, blood sugars and the insulin requirements. The mass of the insulin producing cells and~     their location are not known. The possibility to study the mass of insulin producing cells is~     of importance when developing new treatment regimes, in order to evaluate their efficacy on~     this parameter.~      The researchers in this study are aiming to develop methods to measure the mass of insulin~     producing cells. A method (positron emission tomography, PET) previously used for the~     diagnosis of tumors of insulin producing cells may also be used to measure the amount of~     insulin producing cells in patients with type I diabetes. They plan to evaluate participants~     with type 1 diabetes that have undergone islet transplantation, to evaluate if PET can be~     used to measure the beta cell mass after islet transplantation.~   "
67037|NCT02689466|"~     Background:~      Dystonia is a movement disorder in which a person s muscles contract on their own. This~     causes different parts of the body to twist or turn. The cause of this movement is unknown.~     Researchers think it may have to do with a chemical called acetylcholine. They want to learn~     more about why acetylcholine in the brain doesn t work properly in people with dystonia.~      Objective:~      To better understand how certain parts of the brain take up acetylcholine in people with~     dystonia.~      Eligibility:~      Adults at least 18 years old who have DYT1 dystonia or cervical dystonia.~      Healthy adult volunteers.~      Design:~      Participants will be screened with a medical history, physical exam, and pregnancy test.~      Study visit 1:~      Participants will have a magnetic resonance imaging (MRI) scan of the brain. The MRI scanner~     is a metal cylinder in a strong magnetic field that takes pictures of the brain. Participants~     will lie on a table that slides in and out of the cylinder.~      Study visit 2:~      Participants will have a positron emission tomography (PET) scan. The PET scanner is shaped~     like a doughnut. Participants will lie on a bed that slides in and out of the scanner. A~     small amount of a radioactive chemical that can be detected by the PET scanner will be given~     through an IV line to measure how the brain takes up acetylcholine.~   "
67038|NCT02689453|"~     Background:~      Adult T-cell leukemia (ATL) is a rare blood cancer. Researchers want to see if a combination~     of two drugs - recombinant human interleukin 15 (rhIL-15) and alemtuzumab - is a better~     treatment for ATL.~      Objectives:~      To test if giving rhIL-15 combined with alemtuzumab improves the outcome of therapy for ATL.~     Also, to determine the safe dose of this combination and identify side effects and effects on~     the immune system.~      Eligibility:~      Adults 18 years and older with chronic or acute ATL who have not been helped by other~     treatments.~      Design:~      Participants will be screened with tests that are mostly part of their usual cancer care.~     They will sign a separate consent form for this.~      Weeks 1 and 2: Participants will have a total of 10 visits. They will:~        -  Get rhIL-15 under the skin by needle.~        -  Have a physical exam and vital signs measured.~        -  Give blood samples.~        -  Answer questions about their health and their medicines.~      Week 3: Participants will stay in the clinic. They will:~        -  Get alemtuzumab infusions in a vein through a small catheter on days 1, 2, 3, and 5..~        -  Take medicines to decrease side effects.~        -  Have a computed tomography (CT) scan to evaluate the treatment.~        -  Have a physical exam and vital signs measured.~        -  Give blood samples.~      Answer questions about their health and medicines.~      Weeks 4, 5, and 6 will repeat week 3, without the CT scan. Some patients will just have~     outpatient visits these weeks.~      After treatment, participants will have follow-up visits every few months for up to 2 years.~     At these visits, participants will give blood samples and have CT scans.~   "
67039|NCT02689440|"~     The goal of this clinical research study is to learn if giving half of the recommended FDA~     approved dose of dasatinib can help to control CML as effectively as the full dose of~     dasatinib.~      Researchers also want to learn if combining venetoclax with dasatinib after 3 months of~     dasatinib alone is helpful in controlling CML compared to dasatinib alone.~      The safety of the combination will also be studied.~      This is an investigational study. Dasatinib is FDA approved and commercially available for~     the treatment of CML. It is considered investigational to give a lower dose of dasatinib to~     treat CML. Venetoclax is FDA approved and commercially available for the treatment of chronic~     lymphocytic leukemia (CLL). It is considered investigational to give venetoclax in~     combination with dasatinib to patients with CML.~      The study doctor can explain how the study drugs are designed to work.~      Up to 140 participants will take part in this study. All will be enrolled at MD Anderson.~   "
67040|NCT02689427|"~     The goal of this clinical research study is to learn if a combination of enzalutamide and~     paclitaxel can help to control triple-negative breast cancer (TNBC) by shrinking the tumors~     in the breast and/or lymph nodes before they are surgically removed. The safety of this~     treatment combination will also be studied.~      This is an investigational study. Paclitaxel is FDA approved and commercially available for~     the treatment of breast cancer that does not respond to chemotherapy. Enzalutamide is not~     FDA-approved for breast cancer. It is currently being used for research purposes only in~     breast cancer patients. The study doctor can explain how these study drugs are designed to~     work.~      Up to 37 participants will be enrolled in this study. All will take part at MD Anderson.~   "
67041|NCT02689414|"~     The purpose of this study is to evaluate the effect of preoperative remote ischaemic~     preconditioning (RIPC) on organ damage and the functional characteristics of arteries in~     patients undergoing vascular surgery. In addition, we investigate the connection between RIPC~     and changes in the functional characteristics of arteries and low molecular weight~     metabolites.~   "
67042|NCT02689401|"~     This research study is evaluating a new imaging method using MRI (magnetic resonance imaging)~     to evaluate lymph nodes for evidence of tumor spread from esophageal cancer. This MRI study~     involves an intravenous contrast called Ferumoxytol (FerahemeTM).~   "
67043|NCT02689388|"~     Post operative delirium is common after hip fracture surgery and is associated with increased~     length of hospital stay, delayed recovery and increased mortality. Postoperative delirium can~     also decrease a patient's quality of life and increase treatment costs. Anesthesia and pain~     relief (analgesia) treatments may also influence the incidence of delirium, but more research~     is needed into which techniques are effective in improving patient outcomes, care and~     decreasing costs. This pilot study compares the addition of regional analgesia as part of~     general anesthesia to determine the incidence of delirium following hip surgery. This is a~     collaborative study involving anesthesia, orthopedic surgery and geriatrics in the~     improvement of patient care.~   "
67058|NCT02689193|"~     The IDIS study aims to develop a new rapid diagnostic test for invasive salmonellosis using~     samples (blood, urine) collected from patients with fever and healthy controls at the~     Institute of Tropical Medicine (ITM) and collaborating centers. The samples are collected~     after informed consent and/or assent is given by the participant and are stored in a -80 ⁰C~     freezer after processing (centrifugation and/or aliquoting). Basic information regarding the~     patient and the samples are coded and stored in a protected Microsoft Access database. The~     samples will be shipped to Belgium for proteomic analysis. Identification of Salmonella~     specific proteins in the samples will hopefully support the development of a rapid diagnostic~     test. Once this test has been developed, the samples will also be used for validation and~     evaluation of this test.~   "
67044|NCT02689375|"~     25 participants with back pain and no previous spinal surgery will be enrolled from a single~     NHS site in England.~      Participants will have already discussed spinal cord stimulation (SCS) pain management with~     their consultant before being invited to participate. Participants will attend for 10 visits~     over a period of 66 months. At visit one, study suitability screening and informed consent~     will be conducted. Suitable participants will be booked to have SCS trial leads implanted and~     an external programmable High Frequency battery trial box as a day case (Visit 2).~     Participants will be contacted over the next 21 days to assess how the trial is progressing~     and to book a follow up appointment in clinic to remove the trial leads (Visit 3) where a~     treatment decision will be made. If a participant is determined as having had a successful~     trial they will be listed and implanted with a full HF10 SCS implant (Visit 4). The~     participants who proceed to a full HF10 SCS implant will be reviewed in the Clinic at 6, 12,~     24, 36, 48 and 60 months post procedure. Their participation in this study will be no longer~     than 66 months. A successful trial is defined as a reduction in pain by 30% on a Visual~     Analogue Scale. Participants who do not obtain 30% reduction in 21 days is classed as a~     failed trial and once the leads are removed will be reviewed in clinic by the investigator~     for an alternative treatment plan (Visit 4). If a participant is determined a failed trial of~     HF10, they will remain in the study with their consent for the full follow up schedule. The~     follow-up for the failed trial cohort can be conducted via telephone to reduce the burden on~     this trial group.~   "
67045|NCT02689362|"~     This phase II, multicenter, randomized, double-blind, double-dummy study with four parallel~     treatment groups, with active control, will be performed only in brazilian sites under the~     sponsorship of Eurofarma Laboratórios S.A.. The enrollment for participants in the study will~     start after the relevant ethical and regulatory approvals and will have an estimated duration~     of 18 months.~      One hundred and forty-four participants with T2DM according to the criteria of ADA who~     consent to participation in the study by signing the Informed Consent Form (ICF) will be~     enrolled in the study. In order to be enrolled, the patients must meet all the inclusion~     criteria and none of the exclusion criteria. The eligible participants will be randomized~     1:1:1:1 to receive evogliptin (EVO) at the doses of 2.5 mg/day (N = 36), 5.0 mg/day (N = 36)~     or 10 mg/day (N = 36) or sitagliptin (SITA) at the dose of 100 mg/day (N = 36), as a single~     daily dose, for 12 weeks.~   "
67046|NCT02689349|"~     The New Enrollment Post-Approval Study is designed to evaluate the safety and efficacy of the~     Esteem Totally Implantable Hearing System in subjects suffering from moderate to severe~     hearing loss.~   "
67047|NCT02689336|"~     This study proposes to treat patients with the combination of erlotinib and temozolomide.~     Patients with relapsed, recurrent, refractory, or high risk malignancies whose tumors possess~     a non-synonymous mutation in EGFR, ERBB2, or JAK2V617F (JAK2) will be eligible for the study.~     Very few phase 2 clinical trials have been performed in pediatrics using targeted agents in~     combination with conventional chemotherapy agents. Furthermore, since some combinations such~     as the combination of this study (erlotinib and temozolomide) have shown additive/synergistic~     effects in preclinical studies, therapy selecting for those patients who possess mutations~     targeted by the TKI of the study, may unveil activity that has not been previously observed.~     Thus, the investigators hope to determine whether the addition of additive/synergistic~     chemotherapy will increase efficacy of target agent and/or increase tumor susceptibility to~     targeted agent resulting in increased anti-tumor activity.~   "
67048|NCT02689323|"~     The purpose of this study is to investigate the modulatory effects of repetitive transcranial~     magnetic stimulation (rTMS) on functional connectivity with the insula. Functional~     connectivity (FC) measures the interaction between brain regions, and recent neuroimaging~     studies have used FC to investigate how addiction affects FC among pertinent brain regions.~     rTMS, which can excite cortical neurons, has shown promise as a method to manipulate brain~     connectivity and could be used therapeutically to treat addiction. However, investigators~     first need more information on brain FC and how it relates to behavior, in order to guide~     rTMS target selection.~   "
67049|NCT02689310|"~     The investigators hypothesize that the use of leptospermum scoparium honey as a type of~     dressing and/or debridement agent on stage III or IV pressure ulcers has an increased~     efficacy and safety compared to the current treatment protocol that includes the use of~     hydrogel/Vaseline, collagenase, and silver alginate dressings as the standard of care.~     Utilizing a non-inferiority trial, it is expected that the use of leptospermum scoparium as a~     treatment for Stage III and Stage IV pressure ulcers will not be inferior to the comparison~     treatment of standard of care wound dressings. Moreover, this research design will enable the~     research team to determine if the honey based dressings are equivalent to or superior to the~     comparison treatment.~      Therefore, the investigators specific study objectives are as follows:~        1. Primary Objectives: Determine if the use of honey as an alternative treatment will~          reduce site inflammation/irritation and pain associated with pressure ulcers compared to~          the standard treatment options. Specifically, the investigators will monitor patient~          PUSH scores, Braden Risk Scale scores, granulation and/or epithelial tissue progression,~          length of time to heal, patient pain assessments via the Wong Baker Face or Numeric~          Scale, wound odors, and incidence of adverse events (measured by allergies, stinging~          sensations, bacterial infections that warrant antibiotic intervention, etc.).~        2. Secondary Objective: Patients in the honey treatment group will have lower costs per~          healed ulcer than patients in the standard collagenase treatment group.~   "
67050|NCT02689297|"~     The purpose of the study is to evaluate the effect of various oral hygiene regimes on three~     volatile sulfur compounds.~   "
67051|NCT02689284|"~     This main purpose of this clinical study is to learn about the safety and activity of~     margetuximab and pembrolizumab combination treatment in patients with HER2+ gastric and~     gastroesophageal junction cancer.~   "
67052|NCT02689271|"~     To enable the paradigm of mp-MRI before biopsy in all patients with suspected prostate cancer~     by better selecting patients who will benefit from diagnostic MRI and by improving the~     performance of the mp-MRI itself~   "
67053|NCT02689258|"~     A Phase 2, Randomized, Controlled Evaluation of the Efficacy and Safety of HTX-011 or HTX-002~     for Post-Operative Analgesia Following Abdominoplasty Surgery~   "
67059|NCT02689180|"~     The ReBIC-1 trial was designed to evaluate the potential clinical risks and benefits of~     withdrawing furosemide use in stable, apparently euvolemic, chronic HF outpatients in a~     multicentric double-blinded randomized clinical trial.~   "
67060|NCT02689167|"~     Patients who are candidates for first line treatment with Sunitinib 50mg 4/6 regimen in~     accordance with the Marketing Authorisation who meet the inclusion/exclusion criteria will be~     offered participation in this study during the consultation as part of their usual care. The~     patients will be included before Sunitinib treatment is started. Thereafter, sunitinib is~     initiated 50 mg/day; regimen 4/6 (Marketing Authorisation Indication), 4 weeks on ~     alternating with 2 weeks off ~      As soon as a dose or schedule adjustment is required, regardless of cause, the patient will~     be randomised 1/1:~        -  Either into arm A and will receive 37.5mg of Sunitinib per day by the 4/6 regimen (in~          accordance with the Marketing Authorisation); 4 weeks on  alternating with 2 weeks~          off ~        -  Or into arm B and will receive 50mg of Sunitinib per day by the 2/3 regimen~          (investigational arm); 2 weeks on  alternating with 1 week off ~   "
67061|NCT02689154|"~     The investigators will test a recent mobile technology based (mHealth) behavioral weight loss~     intervention (W8Loss2Go), which is designed for children and adolescents, and uses an~     addiction model to promote withdrawal from problem foods, snacking, and excessive amounts at~     meals. The investigators will test whether this intervention will reduce body mass index~     (BMI), help subjects identify and withdraw from problem foods, eliminate snacking, and~     reduce the amounts of foods consumed at home meals.~   "
67062|NCT02689141|"~     A prospective, open-label, multicentre phase-II trial to evaluate the efficacy and safety of~     a sequential regimen of bendamustine followed by ofatumumab and ibrutinib followed by~     ibrutinib and ofatumumab maintenance in CLL patients.~   "
67063|NCT02689128|"~     Postoperative nausea and vomiting (PONV) is a frequent complication of surgery and~     anesthesia.~      The aim of this study is to estimate the incidence and the risk factors of PONV at Jordan~     University Hospital over one year period.~   "
67064|NCT02689115|"~     Rheumatoid arthritis (RA) is a systemic and auto-immune disorder whose primary characteristic~     is the chronic inflammation of joints. The objective of this study was to evaluate whether~     there was an association between the NF-KB1/IKK epsilon genetic expression and the clinical~     activity in RA.~      60 RA patients were included in the study, 30 with clinical activity and 30 with clinical~     remission The NF-KB1/IKK epsilon genetic expression was performed by real time quantitative~     Polymerase chain reaction (qPCR) through the Pfaffl method of relative quantification with~     Taqman probes.~   "
67065|NCT02689102|"~     Often, assessing a classifying diagnosis in patients with interstitial lung disease provides~     a diagnostic challenge. Currently HRCT, endoscopic or surgical video assisted thoracoscopic~     surgery(VATS) assessment including lung biopsies are diagnostic tools for patients with~     suspected ILD. However, tissue acquisition is associated with morbidity in these patients~     with an already compromised pulmonary function. In clinical practice this results in the fact~     that only a minor part of patients with an indication for tissue acquisition are actually~     undergoing biopsies. The aim of this study is to determine ILD-characteristics on imagign~     collected with minimal invasive novel optical techniques, to examine whether the addition of~     novel optical techniques to the diagnostic process of ILD could potentially limit the need~     for a tissue- (surgical) diagnosis and/or reduce the sampling error rate of biopsies by~     providing additional information on biopsy location.~   "
67066|NCT02689089|"~     This phase IV clinical study trial will be conducted among persons who require treatment for~     LTBI treatment in Iqaluit, Nunavut and Ottawa, Ontario. The primary objective of this study~     is to compare the proportion of people who complete directly observed prophylactic treatment~     (DOPT) using the new 3HP regimen to the current standard of 9 months INH.~   "
67067|NCT02689076|"~     Among older VA patients who have Medicare coverage, 43% use both VA and non-VA~     (Medicare-covered) services. VA and non-VA providers are often uninformed about encounters,~     treatments and test results provided in the other system. The overall objective of this~     project is to examine the impact of VA provider notification of non-VA hospitalization or~     emergency department (ED) visit using electronic health information exchange (HIE), along~     with provision of post-hospital care coordination services. The investigators will examine~     the impact of these approaches on preventing hospital readmission, increasing provider~     follow-up, improving patient's self-knowledge, and preventing medication errors. The~     investigators will also examine the effect of these approaches on VA and non-VA costs.~     Finally the investigators will examine the acceptance of these approaches among VA and non-VA~     providers. The study sample will consist of Veterans followed in geriatrics or primary care~     clinics at the Bronx and Indianapolis VAs who are older than 65. The investigators will~     monitor patients for non-VA hospital admission or ED visit using technology provided by~     health information exchange organizations. Patients will be assigned to enhanced or control~     treatment groups. For both groups the VA provider will receive an electronic notification of~     a non-VA hospital admission or ED visit if it occurs. For the enhanced group, a care~     transitions coordinator will deliver post-hospital coordination services during a home and/or~     VA facility visit and follow-up phone calls over 1 month. The investigators' analyses will~     compare effects of notification-plus-coordination versus notification-only on health care~     outcomes. The investigators will conduct interviews with intervention team members, patients,~     VA and non-VA staff, and other stakeholders to ascertain the barriers and facilitators to~     implementation of these approaches.~   "
67068|NCT02689063|"~     The purpose of the study is to determine the clinical efficacy and safety of Maxigesic IV,~     acetaminophen IV, Ibuprofen IV versus placebo IV for the treatment of acute postoperative~     pain after bunionectomy~   "
67069|NCT02689050|"~     EUS-FNA is the recommended diagnostic examination of choice when patients present with~     suspected lower mediastinal lymph nodes on imaging. EUS-FNA is minimal invasive and low in~     costs, and although it has a good record in detecting diseases (eg confirm a nodal metastasis~     or granulomas) it has limitations in excluding diseases (missing metastases/ or granulomas)~     resulting in a false negative rate of 15-20%. Substantial limitations that most likely can be~     attributed to areas within the node that are not sampled during EUS-FNA tissue acquisition.~     Improved needle based EBUS/ EUS guided nodal diagnostics might result in improved quality of~     the fine needle aspirations, reduce in surgical diagnostic procedures , reduced costs and~     result in a shorter timebefore-treatment interval.~   "
67070|NCT02689037|"~     Background: Effectiveness of Percutaneous transluminal angioplasty and stenting (PTAS) on~     prevention of events of stroke and death in patients with symptomatic intracranial~     atherosclerosis (ICAS) is controversial.~      Aim: to determine whether PTAS plus medical treatment (MT) are superior to MT alone in~     preventing events of stroke and death in patients with symptomatic ICAS.~      Methods: The investigators will carry out a randomized controlled trial in 3 hospitals in~     China. A total of 198 patients with ICAS will be randomized into 2 groups: PTAS+MT and MT~     group. All patients will receive aspirin (100 mg daily) and clopidogrel (75 mg daily)~     immediately after randomization, and patients in PTAS+MT group will receive surgery within 5~     days after randomization. The patients will be followed up for 1 year after randomization and~     assessed for events of stroke and death at 30 days and 1 year after randomization, the~     incidence of recurrent ischaemic stroke in the stenting-involved vascular territory at 30~     days and 1 year after randomization, incidence of in-stent restenosis at 1 year after~     randomization,etc.~   "
67071|NCT02689024|"~     A broken hip occurs frequently in elderly patients and is often very painful. Side effects of~     inadequately treated pain as well as the traditional drugs (administered through intravenous~     catheter) used to treat pain are, among others, a confusional state, called delirium. When~     pain medication is administered locally, only around the hip joint, pain might be treated~     more effectively and these side effects could be prevented. This is called a nerve block.~      The current study evaluates the use of a continuous nerve block throughout the complete~     hospital admission with a catheter around the hip joint versus the use of traditionally used~     pain medication administered though an intravenous catheter in elderly patients with a broken~     hip. Half of all patients will receive the nerve block while in the emergency department and~     the other half will receive pain medication through the intravenous access.~   "
67072|NCT02689011|"~     This study aims to compare the incidence of urinary retention and requirement of bladder~     catheterization in patients undergoing total knee arthroplasty while receiving either~     continuous epidural analgesia or single shot femoral nerve block.~   "
67073|NCT02688998|"~     In the REaCT-Vascular Access Her2 negative study, the investigator will use a novel method to~     allow comparisons of established standard of care vascular access strategies using the~     integrated consent model as part of a pragmatic clinical trial.~      Determining the optimal vascular access strategy remains an important medical issue for~     patients, nurses, physicians and society. A novel method to allow comparison of established~     standards of care is needed as part of an increasing internationally mandated incentive to~     perform more pragmatic clinic trials.~   "
67074|NCT02688985|"~     This is an open-label, multicenter, biomarker study designed to be hypothesis-generating in~     order to better understand the mechanism of action of ocrelizumab and B-cell biology in RMS~     or PPMS. The study will be conducted in two cohorts i.e. RMS cohort (4 arm group) and PPMS~     cohort (one arm group). RMS cohort: Ocrelizumab will be administered as two intravenous (IV)~     infusions of 300 milligrams (mg) on Days 1 and 15. Subsequent doses will be given as single~     600-mg infusions at Weeks 24 and 48. Participants will be randomized in 1:1:1 ratio to~     receive lumbar puncture (LP) post-treatment at Week 12, 24, or 52 following the first dose of~     ocrelizumab in three arm groups. A fourth RMS arm with delayed treatment start (Arm 4~     [control group]) will not be a part of the randomization and will be recruited separately,~     wherein treatment with ocrelizumab will be delayed for 12 weeks from pre-treatment baseline.~     PPMS cohort: Ocrelizumab 600 mg will be administered as two 300-mg IV infusions separated by~     14 days at a scheduled interval of every 24 weeks. Participants will receive a LP at the~     start of the study before dosing with ocrelizumab and second LP at Week 52 following the~     first dose of ocrelizumab.~   "
67075|NCT02688972|"~     Football is a sport with congested calendars, which requires muscle recovery strategies such~     as cold water immersion (CWI). This recovery technique is well spread through football clubs,~     although it lacks a profound physiologic investigation to understand its effects on athlete's~     body. Objectives: The main objective of this study is to evaluate the effect of a long-term~     CWI exposure in football athlete's.~      Study Hypothesis:~      H0: The application of Cold water immersion doesn't amend the biomarkers, electromyograph~     signal, power and perceived of recover when compared with control sample.~      H1: The application of Cold water immersion amends the biomarkers, electromyograph signal,~     power and perceived of recover when compared with control sample.~   "
67076|NCT02688959|"~     The investigators will perform a feasibility/pilot trial of two non-pharmacological~     interventions for ADHD in college students.~   "
67077|NCT02688946|"~     Rationale: The interaction between macro and microcirculation remains uncertain.~     Microvascular alterations can occur when systemic hemodynamic parameters are within an~     acceptable range. Perfusion changes and microvascular alterations may play an important role~     in anastomotic healing and the onset of anastomotic leakage after gastrointestinal surgery.~     Nowadays, assessment of bowel perfusion is macroscopically performed by the surgeon prior to~     anastomosis creation. However, local oxygen delivery may still be compromised as little is~     known about microcirculatory alterations of the bowel during colorectal surgery. Dark Field~     (DF) imaging is a technique using a stroboscopic light-emitting diode ring-based imaging~     modality incorporated in a hand-held device, which illuminates an area of interest and~     provides high contrast dynamic images of the microvasculature. DF-imaging enables to~     visualize the bowel's microcirculation.~      Objective: To describe the human gastrointestinal microcirculation during gastrointestinal~     surgery under general anesthesia and to observe whether there is a correlation between bowel~     microcirculation and systemic hemodynamic parameters.~      Study design: A prospective, single center, observational, clinical, pilot study.~      Study population: 70 patients undergoing elective, gastrointestinal surgery during which the~     gastrointestinal tract is accessible for DF-imaging.~      Main study parameters/endpoints: To describe human gastrointestinal microcirculation on both~     the serosal and mucosal side of the bowel during gastrointestinal surgery under general~     anesthesia. Main parameter: Microvascular perfusion is quantified using the Microvascular~     Flow Index (MFI).~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: The extend of burden and risk associated with participation is negligible. Using~     DF imaging on the bowel is a non-invasive technique requiring a minimal amount of time as is~     described in the study procedure. Previous studies did not show any safety concerns.~     Measuring will be performed under sterile conditions and the occurrence of tissue damage is~     highly unlikely. Patients are under general anesthesia and will thus not experience any~     inconvenience.~   "
67078|NCT02688933|"~     Primary Objective:~      To demonstrate that morning injection of Toujeo compared to Lantus will provide better~     glycemic control evaluated by Continuous Glucose Monitoring (CGM) in adult patients with type~     1 diabetes mellitus.~      Secondary Objective:~      To demonstrate that treatment with Toujeo compared to Lantus will provide:~        -  Lower incidence rate of nocturnal symptomatic hypoglycemia;~        -  Better glucose control coverage during the last hours of CGM before next basal-insulin~          dosing;~        -  Less variability in CGM profile.~   "
67079|NCT02688920|"~     This observational study is conducted to determine how the duodenal layer thicknesses~     (mucosa, submucosa, and muscularis) vary with several factors in patients with and without~     type 2 diabetes.~   "
67091|NCT02688764|"~     This a Phase 3, Open-label, Randomised, Active-controlled, Parallel Group, Multicentre Study~     to Investigate the Safety and Efficacy of PA21 (Velphoro®) and Calcium Acetate (Phoslyra®) in~     Paediatric and Adolescent CKD Patients with Hyperphosphataemia. The aim of this Phase 3~     clinical study is to demonstrate similar efficacy of PA21 (Velphoro) in paediatric and~     adolescent patients with CKD, and to provide safety and dosing information for this patient~     population. The Phoslyra (comparator) group provides information for a descriptive comparison~     of PA21 against a commonly used calcium-based phosphate binder (calcium acetate).~   "
67092|NCT02688751|"~     A single site cross-sectional comparison of paired diagnostic imaging modalities.~      This study will show the sensitivity and specificity of CEUS in detecting the various types~     of endoleaks, in comparison to tCTA, following EVAR. It will collect data to allow comparison~     of diagnostic accuracy across modalities including CDU, CEUS and tCTA. It will collect time~     taken to perform the various types of scan, to allow healthcare costs to be calculated for~     each imaging modality.~   "
67080|NCT02688907|"~     AZD1775 (previously known as MK-1775 in earlier studies) is an inhibitor of Wee1, a protein~     tyrosine kinase. Wee1 phosphorylates and inhibits cyclin-dependent kinases 1 (CDK1) and 2~     (CDK2), and is involved in regulation of the intra-S and G2 cell cycle checkpoints.~      CDK1 (also called cell division cycle 2, or CDC2) activity drives a cell from the G2 phase of~     the cell cycle into mitosis. In response to DNA damage, Wee1 inhibits CDK1 to prevent the~     cell from dividing until the damaged DNA is repaired (G2 checkpoint arrest).~      Inhibition of Wee1 is expected to release a tumor cell from chemotherapeutically-induced~     arrest of cell replication. In vitro experiments demonstrate that AZD1775 has synergistic~     cytotoxic effects when administered in combination with various DNA damaging agents that have~     divergent mechanisms of action. Therefore, the primary objective of the clinical development~     of AZD1775 is its use as a chemosensitizing drug in combination with a cytotoxic agent (or~     combination of agents) for treatment of advanced solid tumors.~      CDK2 activity drives a cell into, and through, S-phase of the cell cycle where the genome is~     duplicated in preparation for cell division. Inhibition of Wee1 is expected to cause~     aberrantly high CDK2 activity in S-phase cells which, in turn, leads to unstable DNA~     replication structures and ultimately DNA damage. Therefore, it is anticipated that AZD1775~     will have independent anti-tumor activity in the absence of added chemotherapy.~      The tumor suppressor protein p53 regulates the G1 checkpoint. As the majority of human~     cancers harbor abnormalities in this pathway they become more dependent on S- and G2- phase~     checkpoints. Thus, S- and G2-checkpoint abrogation caused by inhibition of Wee1 may~     selectively sensitize p53-deficient cells.~      One hundred percent of SCLC has TP53 mutation, therefore we can expect that most of SCLC have~     lost G1 checkpoint and has high probability of WEE1 dependency for proper DNA repair and cell~     cycle progression. For this reason, SCLC could be a good clinical trial target disease for~     WEE1 inhibitor.~   "
67081|NCT02688894|"~     This protocol is a molecular screening protocol only. No drug intervention study will be~     included in this protocol. Based on the molecular profiling, patients may be eligible for~     drug intervention study of SUKSES trial.~      This procedure can be performed during or after the first-line treatment. DNA will be~     extracted from the archived or fresh tissue and blood. NGS-based cancer panel and Nanostring~     CNV will be tested with DNA from tissue and/or blood.~      Immunohistochemistry and FISH will be done by pathologists using archived or fresh tissue.~      Tumor tissues (fresh or archival) will be analyzed using NGS-based cancer panel, nanostring~     CNV, immunohistochemistry and/or FISH.~      Specific methods of each molecular tests will be defined with standard laboratory manual~     developed by pathologists.~   "
67082|NCT02688881|"~     This study is a single arm, pilot study of sirolimus in patient with~     Phosphatidylinositide-3-kinase (PIK3CA) mutation, PIK3CA amplification , PIK3CA-AKT pathway~     aberration Refractory solid tumor and/or specific sensitivity to mTOR inhibitors by Avatar~     scan that has progressed following standard therapy or that has not responded to standard~     therapy or for which there is no standard therapy.~      sirolimus 1mg will be administered orally daily. To investigate the efficacy and safety of~     sirolimus in patient with Refractory solid tumor.~   "
67083|NCT02688868|"~     The purpose of this study is to evalute the clinical safety and effectiveness of released~     specification (2.25mm) of FirehawkTM Sirolimus target-eluting coronary stent system.~   "
67084|NCT02688855|"~     The OL1000 is intended to be used as a non-invasive adjunctive treatment for adult males or~     females that have sustained a closed, unstable ankle fracture that requires surgical~     treatment for stabilization. The initiation of the adjunctive treatment is to begin within 11~     days of surgical stabilization.~   "
67085|NCT02688842|"~     The purpose of this study is to evalute the clinical safety and effectiveness of released~     specification (38mm) of FirehawkTM Sirolimus target-eluting coronary stent system.~   "
67086|NCT02688829|"~     This is a small-scale pilot clinical study of the Rapamycin-Eluting Coronary Stent System of~     Microport for the first time to assess the preliminary safety and feasibility used in the~     human body. And provide evidence for subsequent large-scale, multi-center, randomized~     controlled clinical trials, then provide the basis for the formal application of the product~     in China.~   "
67087|NCT02688816|"~     This study will compare the test performance characteristics of visual inspection with acetic~     acid (VIA), Xpert HPV, and OncoE6 in HIV-infected women, to inform the possible inclusion of~     these molecular tests in future cervical cancer screening~   "
67088|NCT02688803|"~     Triple-negative breast cancer (TNBC) is a term applied to breast cancer cases that have <1%~     expression of the estrogen receptor (ER) and the progesterone receptor (PR) and do not over~     express HER2.~      TNBC is diagnosed in 15-20% of breast cancer cases and tends to occur in younger women and~     have biologically more aggressive high grade disease. Clinically, patients with TNBC have a~     poorer prognosis compared to patients diagnosed with other breast cancer subtypes. Because of~     the aggressive phenotype and due to observations that systemic chemotherapy offers~     significantly higher benefit in ER negative disease, current treatment guidelines from~     provincial and other organizations recommend that patients receive adjuvant systemic~     chemotherapy for any TNBC greater than 0.5 cm in greatest diameter or node positive~     independent of primary tumor size.~      Currently, there is no world-wide standard recommended chemotherapy regimen for the~     management of TNBC in the neoadjuvant/adjuvant setting, with treatments varying from region~     and institution.~      As physicians do not know what the best treatment for patients is, genuine uncertainty~     (clinical equipoise) exists. Physicians will choose between different standards in their~     personal practice, using idiosyncratic decision making processes, without the physician or~     the patient knowing the optimal option. This is not good for patients, physicians and society~     as a whole. Determining the optimal treatment remains an important medical issue for~     patients, physicians and society. This study will survey opinions on a novel method to allow~     comparisons of established standard of care prophylactic treatment using the integrated~     consent model as part of a pragmatic clinical trial and attempt to compare head to head~     standard chemotherapy regimens in patients with TNBC.~   "
67089|NCT02688790|"~     The purpose of this study is to evaluate the Pharmacokinetic (PK) profile of a single~     intravenous (IV) infusion dose of dalbavancin, and to evaluate the safety and tolerability of~     a single dalbavancin IV infusion.~   "
67090|NCT02688777|"~     Approximately 15,000 Veterans are hospitalized for stroke each year with new cases costing an~     estimated $111 million for acute inpatient, $75 million for post-acute inpatient, and $88~     million for follow-up care over 6 months post-stroke. Contributing to these costs is the~     incidence of falls. Falls are a costly complication for Veterans with stroke as they lead to~     an increased incidence of fractures, depression, and mortality. New strategies are needed to~     help Veterans post-stroke regain their ability to safely walk without increasing their risk~     of falling as well as readily identify those who are a fall risk. This study addresses both~     of these needs as it will 1) investigate a new treatment approach, backward walking training,~     to determine if it will decrease fall incidence in the first year post-stroke and 2)~     determine if backward walking speed early after a stroke can identify those that are at risk~     for future falls.~   "
67094|NCT02688725|"~     Currently, there is no standard recommendation for using imaging studies to check patients~     for breast cancer recurrence who have been treated with mastectomy. The investigator proposes~     performing in-office ultrasound examinations of these patients to determine if this would be~     helpful in identifying an expected 5-7% of patients with breast cancer recurrences following~     mastectomy.~   "
67095|NCT02688712|"~     The purpose of this study is to see how effective and safe LY2157299, in combination with~     chemotherapy and radiation therapy, might be in treating rectal cancer. Also as part of this~     study, research will be done on tumor samples to see if it is possible to predict if patients~     will respond to treatment, and blood samples to look at the immune system response to study~     treatment.~      About 50 people will take part in this study. The study treatment will be given over an 8~     week period and the investigators will continue to collect your health information for up to~     5 years, as part of this study~   "
67096|NCT02688699|"~     The investigators want to verify in a randomised trial, the effectiveness of EndoClotTM in~     preventing post-procedural bleeding after EMR (Endoscopic Mucosal Resection) or ESD~     (Endoscopic Submucosal Dissection) for sessile lesions >20 mm in the right colon~   "
67097|NCT02688686|"~     The purpose of this Phase I/II study is to evaluate the safety and efficacy of dendritic~     cells(DC) vaccine combined with cytokine-induced killer (CIK) cells in patients with Advanced~     Non-Small-Cell Lung Cancer with bone metastases. Experimental DC was transfected Ad5 vector~     coding mRNAs including suppressor of cytokine signaling (SOCS) 1, MUC1 and Survivin,are used~     for DC-based immunotherapy. Based on the results of our previously preclinical study with DC~     vaccine combined with CIK cells, the investigators plan to perform the clinical trial.~   "
67098|NCT02688673|"~     The aim of this study is to evaluate the safety and efficacy of dendritic cells (DC) combined~     with cytokine-induced killer (CIK) cells treatment patients with Extensive-Stage Small-Cell~     Lung Cancer. Experimental adopted recombinant adenovirus-code MUC1 and Survivin transfected~     DC, which are used for DC-based immunotherapy. Based on the results of our previously~     preclinical research with DC combined with CIK cells, the investigators plan to perform the~     clinical trial.~   "
67099|NCT02688660|"~     Traumatic brain injury (TBI) is the leading cause of death or disability in children. Each~     year in the United States, pediatric TBI results in an estimated 630,000 emergency room~     visits, 58,900 hospitalizations, and 7000 deaths. The incidence of long-term disability after~     severe TBI is high, with over 60% of children requiring educational or community based~     supportive services 12 months post-injury. Over 5,000 children require inpatient~     rehabilitation after TBI each year and an estimated 145,000 US children are currently living~     with disabilities after a severe TBI. Hospital costs for the acute treatment of children with~     TBI are estimated at ~$2.6 billion each year, while the gross annual costs accounting for~     long-term care and lost productivity approach $60 billion. Therefore, pediatric TBI is a~     major public health concern and new ways to diagnose and treat TBI are urgently needed.~   "
67100|NCT02688647|"~     This study is being conducted to evaluate the safety, tolerability, and activity of 400 mg of~     KD025 once-daily (QD) compared to standard of care (SOC) in male and~     postmenopausal/surgically sterilized female subjects with IPF.~   "
67101|NCT02688634|"~     Cleft Lip and Palate surgical repair is one of the most common procedures performed by~     Plastic and Reconstructive Surgeons in the World. With this in mind, it is curious that no~     consensus exists regarding the usage of postoperative antibiotics or the effects this might~     have on wound complications such as cellulitis, dehiscence, or fistula formation. The~     surgical bed in cleft lip/palate repair is known to harbor a myriad of pathological~     organisms, indeed the human bite is one of the more clinically and microbiologically~     significant injuries to treat. This research study is to elucidate the role, if any, that~     prophylactic antibiotics have in the prevention of complications post cleft palate (CP) and~     VPI repair and potentially establish a new paradigm of care.~   "
67102|NCT02688621|"~     The investigators propose a randomized controlled trial to evaluate whether the addition of~     financial incentives to a high-quality, online behavioral weight loss intervention produces~     better weight losses than the online treatment alone.~   "
67103|NCT02688608|"~     This study is being done because there are currently no approved and no commonly working~     targeted therapies in anaplastic thyroid cancer (ATC). This is an area of urgent need for~     patients, not just for approved treatments but also rationally-designed clinical trials~     designed specifically for ATC. Patients diagnosed with anaplastic thyroid cancer have a very~     high likelihood of dying because of their disease. As such there is a clear need for~     improving therapy for ATC.~   "
67104|NCT02688595|"~     The purpose of this study is to compare the differences in central venous catheter insertion~     time, success rate, and complication between the Seldinger and modified Seldinger technique~     for ultrasound-guided central venous catheterization in neonates.~   "
67105|NCT02688582|"~     For this study, a previously developed population pharmacokinetic (popPK) model for cefepime~     (Jonckheere et al., submitted to JAC) was programmed in Rugloop vII, which is a software~     program to drive an infusion pump. By entering patient data (such as gender, serum~     creatinine, age and weight) in Rugloop II, a patient-specific dose will be calculated and~     given to the patient. This concept is known as Target Controlled Infusion (TCI). The aim of~     this study is to prospectively validate the popPK model using TCI.~   "
67106|NCT02688569|"~     This randomized controlled clinical trial will examine the effects of Cognitive Behavioral~     Therapy (CBT-) in patients with comorbid chronic widespread pain (CWP) and insomnia.~      Specific Aims:~        1. To examine the clinical and health characteristics, including sleep, pain, fatigue,~          cognitive abilities, and cardiovascular health in patients with comorbid CWP and~          insomnia.~        2. To examine changes in the primary clinical outcomes, including chronic pain, complaints~          of poor sleep, and fatigue compared to the waitlist control (WLC).~        3. To examine changes in the secondary clinical outcomes, including mood, daytime~          functioning, cognitive functioning, and cardiovascular health compared WLC.~        4. To examine the mechanistic variables, including arousal (heart rate variability, HRV),~          CS (thermal response) and neural plasticity (brain function and structure) - compared to~          WLC.~   "
67107|NCT02688556|"~     This is a randomized, double-masked, vehicle-controlled study of the safety and efficacy of~     OTX-101 (0.09% cyclosporine nanomicellar solution) in the treatment of keratoconjunctivitis~     sicca to be conducted at approximately 50 sites.~   "
67108|NCT02688543|"~     Pharmacological treatment of pain due to osteoarthritis of the knee often proves to be~     inadequate and/or cause intolerable side effects. Arthroplasty of the knee may offer a~     solution, but waiting lists may be long or certain patients may not be apt for a surgical~     intervention. Therefore an alternative pain treatment that is effective and has little side~     effects allowing to offer pain relief to those difficult to manage patients would be an added~     value in the therapeutic options.~      We studies the short and long-term effects of radio frequency treatment of the genicular~     nerves in patients with severe pain due to osteoarthritis of the knee.~   "
67109|NCT02688530|"~     For surgery involving the shoulder, anesthesiologists will often inject local anesthetic~     numbing medication near nerves supplying the shoulder in what is called a supraclavicular~     nerve block. These nerve blocks cause numbness and weakness in the shoulder leading to~     relaxation of the joint which is helpful to the surgeon and allowing for painless surgery~     without general anesthesia. After surgery, pain relief is sustained for the duration of the~     nerve block.~      The primary purpose of this study is to clarify the duration of pain control provided by~     supraclavicular blocks when supplemented with varying doses of the steroid anti-inflammatory~     dexamethasone when given through the intravenous line (IV). IV dexamethasone is commonly used~     for both nausea prevention and block prolongation, but a detailed study of the effect of~     varying doses of this medication on duration of pain relief and weakness from the block has~     not been studied. The study investigators seek to identify what association, if any, is noted~     between IV dexamethasone doses and changes in blood glucose levels after shoulder surgery~     with regional anesthesia and sedation. Finally, the study investigators will collect data on~     side-effects and postoperative complications, if any, in patients receiving a range of doses~     of IV dexamethasone.~   "
67110|NCT02688517|"~     This research trial studies the use of targeted genomic analysis of blood and tissue samples~     from patients with cancer. Genomic sequencing is a laboratory method that is used to~     determine the entire genetic makeup of a specific organism or cell type. Genomic sequencing~     can be used to find changes in areas of the genome that may be important in the development~     of cancer. It may also help doctors improve ways to diagnose and treat patients with rare~     cancers with poor prognosis or lack of effective therapy.~   "
67111|NCT02688504|"~     In France, drugs affecting driving ability directly or by indicating at-risk diseases are~     classified in a 4-level standardized classification associated with a graded pictogram.~      When the French authorities required this graded pictogram, they commissioned the CESIR-U1~     study, a study designed to describe the use of labelled medicines by drivers involved in~     serious road accidents (hospitalization > 24h). This study, conducted in Bordeaux, Limoges~     and Toulouse, recruited 679 drivers involved in serious road accidents. When the~     responsibility of the driver is taken into account, it appears that the association of risk~     factors (alcohol, sleep, ...) and the use of labelled drugs increases this responsibility.~     Even though labelled medicines seemed slightly more at risk than unlabelled ones, this did~     not reach significance.~      This conclusion is different from the conclusion of CESIR-A, a data linkage study of the~     police and the health insurance databases which showed a correlation between the use of grade~     2 or 3 labelled medicines and driver responsibility.~      This difference between CESIR-U and CESIR-A could be related to a lack of power or to the~     characteristics of the subjects included (mostly young men and motorcycle drivers). That is~     why it was thought interesting to increase the size of the sample and to include non serious~     road accidents (hospitalization < 24 hours) that represent around 73% of accidents.~   "
67112|NCT02688491|"~     Whether patients with stage III clear cell renal cell carcinoma(ccRCC) should receive~     adjuvant targeted therapy or not is still on debate. The investigators invented a assay~     consisting of 5 CpGs: cg00396667（PITX1）, cg18815943 （FOXE3）, cg03890877（TWF2）, cg07611000~     （EHBP1L1）and cg14391855（RIN1）that was successfully categorise patients with stage III clear~     cell renal cell carcinoma into high-risk and low-risk groups with Harzard Ratio(HR) of 4.93.~     Here the investigators randomly assign assay-defined high risk patients of locally advanced~     ccRCC into adjuvant targeted therapy group and observation group.Disease free survival and~     overall survival are the end points of observation.~   "
67113|NCT02688478|"~     Phthalates are commonly used plasticizers that have been linked to asthma in epidemiological~     studies. The investigators are researching effects of phthalates on airway immunology and~     lung function, and on allergic responses by doing an inhaled allergen challenge. After~     exposing participants to either filtered air or carefully controlled levels of phthalate in~     our exposure chamber we will collect samples from the nose and the upper airways, by rinsing~     the nose with saltwater or performing small brushings. The investigators will also collect a~     bronchial samples by bronchoscopy after each exposure. After 2 weeks, the entire procedure~     will be repeated with the alternate exposure.~   "
67114|NCT02688465|"~     Parkinson's disease is not only a pathology of movements. There are many non-motor symptoms~     that complicate and impair patients' quality of life. Among those disorders are sleep~     disorders.~      Insomnia is the most frequent symptom. Most patients report 2-5 awakenings per night and long~     periods of awakening which occupy 30 to 40% of their night.~      Apomorphine is a dopamine agonist that may be administered with a pump . The objective of the~     study is to assess changes in the quality of sleep in Parkinson's disease patients treated~     with an apomorphine pump.~   "
67115|NCT02688452|"~     The primary purpose of this interventional, placebo controlled, crossover, double blind,~     basic science exploratory study is to investigate whether there is a difference in brain~     electrophysiological oscillatory activity in healthy adults before and after oral consumption~     of water containing very small bubbles of oxygen (electrokinetically modified water).~   "
67116|NCT02688439|"~     The primary purpose of this study is to determine whether the leg positioning or distal~     tourniquet used during the injection of local anesthetic may decrease the onset time and~     prolong the duration of analgesia of ultrasound-guided Sciatic Nerve Block (SNB) with~     popliteal approach. Patients will be divided randomly into three groups: group 1 will receive~     sciatic nerve block, with leg kept in a neutral position after anesthesia (control group);~     group 2 will receive the same anesthesia, with leg raised 30° by placing the back of the foot~     over a support placed on the OR table and maintained in that position for 15 min; and~     patients in group 3 will receive the same anesthesia, and distal tourniquet placed on the~     lower part of the leg (upper part of the tourniquet being about 4-6 inches from the ankle)~     with the leg in a neutral position~   "
67117|NCT02688426|"~     The low-level laser therapy (LLLT) has been used in many inflammatory disorders.~      More recently the LLLT was associated with an improvement in the muscle strength, endurance~     and functional capacity.But, these effects were described only in health or athletic~     individuals. In this randomized and controlled clinical trails, the investigators will study~     the effects of LLLT on functional capacity of the patients with Coronary artery bypass~     surgery.~   "
67118|NCT02688413|"~     Randomised controlled multi-centered study using MindMotionPRO, an immersive virtual reality~     based system for upper limb motor rehabilitation in early post-stroke patients. The study~     aims to evaluate the ability of MindMotionPRO technology to increase the rehabilitation dose.~     Effectiveness will be evaluated by validated rehabilitation performance scales.~     Cost-effectiveness will be assessed by the resource utilization.~   "
67119|NCT02688400|"~     Osteoarthritis (OA) of the knee is the most frequent cause of knee pain after the age of 50~     years. OA is a joint disease characterised by articular cartilage loss associated with~     structural changes in the cartilage and adjacent structures. The main symptoms are pain and~     functional disability. The goals of OA therapy are to decrease pain and maintain or improve~     joint function. There is evidence that diacerein has both a symptomatic and a structural~     effect on cartilage, and clinical studies suggest that diacerein therapy significantly~     decreases OA symptoms when compared to placebo. Diacerein has been shown to inhibit~     interleukine-1 (IL-1β), and down-regulated IL-1β stimulated secretion of metalloproteinases~     and aggrecanases, and thereby prevent breakdown of cartilage by these enzymes. Diacerein has~     no effect on the synthesis of prostaglandins, and therefore no effect on the upper intestinal~     tract. The purpose of this phase III-IV international, multicentre, double-blind,~     non-inferiority, randomised, controlled study is to determine the efficacy and safety of~     diacerein vs. celecoxib on symptoms after 6 months of treatment, and on structural changes~     after 2 years of treatment in knee OA patients as assessed by magnetic resonance imaging~     (MRI).~   "
67120|NCT02688387|"~     This study is designed to understand the relative bioavailability (proportion of the~     administered dose that is absorbed into the bloodstream) of several fixed dose combinations~     (FDCs) tablets of ambrisentan and tadalafil for further development and to provide~     pharmacokinetic (PK - what the body does to the drug) data to enable a pivotal bioequivalence~     (BE - the relationship between two preparations of the same drug in the same dosage form that~     have a similar bioavailability) study. Depending on formulation work, the study will allow up~     to 8 new FDCs to be compared with the reference of ambrisentan and tadalafil monotherapies.~     The study will also evaluate up to 2 of the new formulations, that may be taken in to a BE~     study, to be tested for any effect on pharmacokinetics of the FDC in both fed and fasted~     state. This is a single centre, Phase 1, single dose, randomised, open label crossover study~     with 3 study parts; each study part will have up to a 5 way crossover in healthy subjects.~     Part 1 of the study will evaluate four formulations of the FDC (ambrisentan 10 milligram [mg]~     + tadalafil 40 mg) and the reference of the 2 monotherapy components taken concurrently~     (ambrisentan 10 mg and tadalafil 40 mg) in the fasted stated. If successful formulations are~     identified in this part of the study, then they will be re-formulated and tested in part 2.~     If no successful formulations are identified in part 1 of the study, then part 2 will be~     utilized to look at up to 4 new FDC formulations. However, if only two formulations, or less,~     are evaluated in part 2 then the FDC formulations may be tested both fed and fasted to assess~     food effect and part 3 will not be required. If successful formulations are identified in~     this study part, then up to 2 of these may be tested, for food effect, in Part 3 if not~     already assessed in this part. Therefore, part 3 is optional and utility is dependent on the~     results of the previous study parts.~   "
67121|NCT02688374|"~     This is a randomized, open-label, single-dose, three-period, crossover, single-center~     comparative bioavailability (BA) study under fasting condition in Chinese healthy male adult~     participants with a history of cigarette smoking. The participants will be admitted to the~     investigational clinic at least 38 hours before dosing and will remain domiciled until the~     completion of all study procedures at approximately 24 hours after dosing. Three toothpastes~     (one is commercial non-medicated non-nicotine containing chewing gum and other two are~     nicotine containing gums) will be provided across the 3 treatment periods. During each of the~     3 treatment periods, participants will be under supervision in a non-smoking area and will~     abstain from smoking.There will be a total of at least 7 days and not more than 10 days~     (clinical furlough period) between treatment periods. Twenty (20) blood samples will be~     collected for pharmacokinetic (PK) analysis at baseline and multiple time points following~     study drug administration. The trial duration will be approximately 49 days and up to 55 days~     from screening to study end including the screening period.~   "
67122|NCT02688361|"~     This is an open-label, randomized, single-center, 2-period, 2-sequence, single-dose crossover~     design study in adult male and female healthy participants. Eligible participants will~     receive either treatment A (reference): Fluimucil® Acetylcysteine 2% oral solution, 200 mg N-~     acetylcysteine (NAC) in 10 mL dose, or treatment B (test): Acetylcysteine 2% oral solution,~     200 mg NAC in 10 mL dose. Blood sampling will be collected pre-dose and up to 48 hours in~     each period. After completion of the second study period (i.e. last pharmacokinetic (PK)~     sample on Day 3 of Period 2) participants will be discharged from the clinic.~   "
67123|NCT02688348|"~     This research trial studies quality of life after bladder-preservation chemotherapy and~     radiation therapy (chemo-radiotherapy) in patients with bladder cancer that has spread into~     or through the muscle layer of the bladder (muscle-invasive bladder cancer).~     Bladder-preservation chemo-radiotherapy is a standard treatment for patients with~     muscle-invasive bladder cancer, however, chemo-radiotherapy may cause urinary tract, bowel,~     and sexual late side effects that negatively affect patients' quality of life. Studying~     quality-of-life in patients with muscle-invasive bladder cancer after chemo-radiotherapy may~     help identify the long-term side effects of treatment and may help plan the best treatment in~     the future and improve patients' quality of life.~   "
67124|NCT02688335|"~     This is an interventional study in which patients with a history of habitual snoring will use~     the low-pressure CPAP device at home for about 4 weeks. This study is designed to document~     the adherence of the snorer, the acceptance and comfort of the therapy, and bed partners'~     subjective report of improvement in sleep quality, and/or reduction or elimination of~     snoring. Study outcomes will consist of an assessment of the nightly usage time, and~     questionnaires that the snorer and the bed-partner have to complete before the start of the~     study and at the end of the study period.~   "
67149|NCT02688010|"~     Noise is a hazard for newborn. In 1997, the American Academy of Pediatrics determined that~     safe sound levels in the neonatal intensive care unit (NICU) should not exceed 45 dB which~     has been rarely achieved. High intensities of noise have several negative effects on preterm~     newborns. Also, they are exposed to either continuous bright light continuous near darkness~     or unstructured combination of the two during their hospitalizations. The investigators~     primary objective is to determine the impact of reduced noise levels and cycled light on~     growth parameters and visual development in preterm infants.~   "
67150|NCT02687997|"~     Prospective study of sleep disordered breathing in a lung cancer screening cohort.~   "
67125|NCT02688322|"~     Acinetobacter species have emerged as agents of serious nosocomial infections in critically~     ill patients. Only a few effective antibiotics are currently available for the treatment of~     this pathogen and, therefore, sulbactam is being considered as an alternative treatment~     option. The aims of this study were to i) reveal the population pharmacokinetics and ii)~     assess the probability of target attainment (PTA) of sulbactam in septic critically ill~     patients caused by Acinetobacter spp. infections.~      The study was conducted in septic critically ill patients caused by Acinetobacter spp. Each~     patient received 2 g every 12 h of sulbactam for 10 days, after which PK studies were carried~     out on day 4 of sulbactam therapy and a Monte Carlo simulation was performed to determine the~     probability of attaining a specific pharmacodynamic target.~   "
67126|NCT02688309|"~     This study will examine potential factors in the aqueous humor that may contribute to the~     development or progression of macular edema or fibrosis (due to any underlying disease) in~     patients suffering from these conditions.~   "
67127|NCT02688296|"~     The objective of this post-market clinical study is to evaluate efficacy outcomes and~     complication rates in patients who have received the Fibulock™ Intramedullary Nail.~   "
67128|NCT02688283|"~     The objective of this trial is to compare a snack with ingredients (whole grains and dietary~     fiber) to slow carbohydrate digestion to a similar control snack without such ingredients and~     evaluate the effect of the snack on glycemic response and subjective satiety. The test~     product will be compared with a control product as well as white bread in a randomized,~     controlled, crossover trial including 20 healthy males or females between the ages of 18 and~     70 and having a body mass index (BMI) between 25 and 30 kg/m2. Following an overnight fast,~     participants will be given each of the study products in a random order at least a week~     apart. Glucose and insulin will be measured before product consumption and over a period of~     four hours. Visual analog scales to measure subjective satiety will also be administered over~     a period of four hours.~   "
67129|NCT02688270|"~     The purpose of this study is to determine the ability of Vascana (0.9% nitroglycerin topical~     cream) to treat and prevent the symptoms experienced by subject's with Raynaud's Phenomenon.~     The symptoms of this disease include pain, tingling, and numbness in the fingers of the~     affected hand or hands.~   "
67130|NCT02688257|"~     Patients with large primary operable breast cancers are offered chemotherapy prior to surgery~     to shrink the tumour and enable breast conserving surgery. Conventional assessment of~     response to chemotherapy relies on a change in tumour size which does not always correlate~     with the change in amount of viable tumour. Newer techniques such as functional MRI,~     microbubble and optoacoustic ultrasound offer the potential to detect responses to~     chemotherapy by evaluating functional changes in tumour vascularity and oxygenation. Neither~     modality utilises ionising radiation.~      Although MRI is widely used for detecting breast cancer, its ability in assessing functional~     responses to chemotherapy prior to surgery has not been fully exploited. Dynamic contrast~     enhanced (DCE) MRI has a sensitivity around 90% and provides quantitative measurements of~     blood volume and flow. Other functional techniques detect variation in tissue oxygenation:~     this is called the blood oxygen level-dependent (BOLD) mechanism. The BOLD technique uses a~     special magnetic resonance (MR) sequence called T2* to measure the weakly magnetic effect of~     deoxygenated haemoglobin. The investigators wish to develop and validate T2* measurements~     which relate to oxygenation of a tumour. The investigators also want to validate other MR~     sequences including diffusion weighted (DW) MRI, which quantifies microcirculation of blood~     in the capillary network and the diffusion of water within tissues.~      Microbubble ultrasound is an established technique that utilises an intravenous contrast~     agent comprising tiny microbubbles of gas that can increase the reflectivity of blood and~     enhance spectral and colour Doppler signals obtained from routine ultrasound imaging.~     Optoacoustic imaging is new technique where the output signal depends on the oxygenation of~     the tissues under study. It utilises a light signal input and measures ultrasound signal~     output.~      The investigators want to correlate our imaging findings with histopathology after surgical~     resection of the tumour.~   "
67131|NCT02688244|"~     This study evaluates the intraabdominal abscess rate after laparoscopic appendectomy in~     complicated acute appendicitis performing irrigation of the abdominal cavity or only suction~     without lavage.~   "
67132|NCT02688231|"~     An adequate upper limb function is crucial to independently perform Activities of Daily~     Living (ADL). Persons with neurological diseases often experience upper limb dysfunction.~     Upper limb function in Multiple Sclerosis (MS) is highly prevalent, increasing with overall~     disability level, while the detrimental impact on ADL is higher than in stroke, given that~     symptoms often occur bilaterally. In contrast to stroke, it is unknown whether similar~     rehabilitation principles and effect sizes apply in MS given that this progressive~     neurodegenerative disease is characterized by multiple lesions and atrophy of brain~     structures. To date, optimal therapy dosage of upper limb rehabilitation programs are not~     known in the MS literature neither were characteristics of responders identified.~      The aim of this explorative study is to investigate the intensity dependent clinical effects~     of a task-oriented upper limb training in persons with MS with different upper limb~     disability levels.~   "
67133|NCT02688218|"~     The risk of hypoglycemia in individuals with type 1 diabetes increases considerably during~     exercise. As a result, many patients with type 1 diabetes experience fear of and reluctance~     to pursue physical activity, in order to avoid the discomforting symptoms associated with~     hypoglycemia. The bi-hormonal artificial pancreas, a device used for automatic delivery of~     insulin and glucagon subcutaneously to subjects with type 1 diabetes, is paving the way to~     revolutionize the management of this disease. The investigator's group has recently completed~     a study of the bi-hormonal artificial pancreas system during exercise, suggesting reduced~     hypoglycemia around the exercise period. In order to prepare for a future home study, the~     ability to detect, grade, and classify physical activity so as to appropriately adjust system~     parameters is vital in helping to prevent exercise induced hypoglycemia in the home setting.~      This study is designed to collect 3-axis accelerometry data and heart rate data during a~     variety of different home activities, as well as during formal exercise in both healthy~     subjects and subjects with type 1 diabetes. Additionally, the investigators will observe the~     change in glucose levels before and after exercise in subjects with type 1 diabetes.~   "
67151|NCT02687984|"~     Primary Objective: To assess the relative bioavailability of RBP-7000 formulated with 2~     different molecular weights (MW) (low and high MW as test treatments) of poly~     (DL-lactide-co-glycolide) with a carboxylic acid end group (PLGH) polymer compared to~     intermediate MW PLGH polymer following single subcutaneous (SC) injection of RBP-7000 in~     subjects with stable schizophrenia.~      Secondary Objective:~      To evaluate the safety and tolerability of single SC injections of RBP-7000 using a PLGH~     polymer of 2 different MW (low and high MW as test treatments) compared to intermediate MW~     polymer in subjects with stable schizophrenia.~   "
67152|NCT02687971|"~     The purpose of this trial is to determine the efficacy and safety of a combined therapy using~     thermotherapy (TT) (one session, 50 degrees Celsius for 30) + miltefosine at a standard dose~     of 2.5 mg/kg/day for 21 days for the treatment of uncomplicated CL in Peru and Colombia~   "
67134|NCT02688205|"~     Shoulder problems cause substantial disability in daily living, work, leisure activity, and~     exercise. The presence of shoulder problem such as rotator cuff pathology reported was highly~     predictive of impaired health-related quality of life.~      Many tests were used for physical examination of the shoulder. The reliability and validity~     of the tests have been studied before. However, a systemic review concluded that there was~     conflicting evidence in reliability of each or combined tests. Functional examination of the~     shoulder by Cyriax is composed of a series of tests to evaluate a shoulder problem. It~     includes three arm elevation, three tests for glenohumeral joints, and six resisted tests.~      As far as the investigators know, correlation of Cyriax functional examination with the~     ultrasonographic findings has never been reported before. Therefore, the aim of this study is~     to compare the clinical diagnosis by Cyriax's functional examination with ultrasound findings~     in patients with shoulder pain.~   "
67135|NCT02688192|"~     This clinical trial studies a mobile health fitness program for adolescent and young adult~     childhood cancer survivors. Adolescent and young adult childhood cancer survivors are at risk~     to have negative late effects from treatment and to develop chronic health conditions. A~     sedentary lifestyle may increase the risk of cardiovascular disease, osteoporosis, and early~     mortality. Physical activity reduces the risk for cardiovascular disease and early mortality,~     improves cardiorespiratory fitness, muscular fitness, bone health, and body composition, and~     it is also positively associated with quality of life. Programs and technologies that promote~     physical activity are important because health behaviors adopted by adolescent and young~     adult childhood cancer survivors are likely to continue into adulthood. A mobile health~     fitness application may motivate adolescent and young adult childhood cancer survivors to~     engage and maintain physical activity.~   "
67136|NCT02688179|"~     Up to 50% of patients over 60 years old develop postoperative delirium following cardiac~     surgery. Delirium increases morbidity and mortality, and may lead to long-term cognitive~     impairment similar to patients with a diagnosis of Alzheimer's disease. The underlying~     mechanisms behind delirium are not understood, and therefore the current prevention and~     treatment strategies are inadequate. Several hypotheses exist for the pathophysiology of~     delirium, one of which is the role of neuroinflammation. The stress associated with high-risk~     procedures such as cardiac surgery may lead to systemic inflammation causing endothelial~     dysfunction and disruption of the blood brain barrier (BBB). When this occurs, the brain is~     susceptible to neuronal injury via neuroinflammation after which a state of delirium may~     ensue. To characterize the mechanisms of neuroinflammation in delirium, the investigators~     will explore the biomarkers most closely linked to each step of the proposed pathway.~   "
67137|NCT02688166|"~     This research study can help understand how cardiac changes may occur with radiation therapy~     to the heart based off measurements obtained through biomarkers and cardiac imaging.~      Researchers plan to perform cardiac imaging and biomarkers for any cardiac injury. Cardiac~     magnetic resonance imaging (CMR) provides the ability to quantitatively measure cardiac~     function and injury. The cardiac biomarkers that will be tested are effective in the~     diagnosis, risk-stratification, and monitoring of heart failure.~   "
67138|NCT02688153|"~     The study purpose is to compare the EDWARDS INTUITY valve system with commercially available~     stented aortic bioprostheses, in patients requiring aortic valve replacement surgery with~     coronary artery bypass.~   "
67139|NCT02688140|"~     Acute promyelocytic leukemia (APL) is a rare subtype of acute myeloid leukemia (AML)~     characterized by consistent clinical, morphologic, and genetic features. According to the FAB~     classification APL is designated asM3 leukemia and assigned to the WHO defined type of AML~     with recurrent cytogenetic abnormalities, acute promyelocytic leukemia with~     t(15;17)(q22;q12), (PML/RARα) and variants.~      Despite the dramatic progress achieved in frontline therapy of APL with ATRA plus~     anthracycline-based regimens, relapses still occur in approximately 20% of patients.~     Moreover, these regimens are associated with significant toxicities due to severe~     myelosuppression frequently associated with life-threatening infections and potentially~     serious late effects including development of secondary MDS/AML. In a recent randomized~     clinical trial in low/intermediate-risk APL (WBC ≤ 10 GPt/l APL0406 trial) a combination of~     arsenic trioxide (ATO) and ATRA has been shown to result into better survival with~     significantly lower toxicity rates compared to the standard ATRA + idarubicin (AIDA) therapy.~     Inspired by the results of this trial the investigators intend to perform a randomized study~     in high-risk APL (WBC at diagnosis > 10 GPt/l) comparing standard AIDA-based treatment with~     ATO/ATRA combination including low-doses idarubicin during induction. The investigators~     propose a modified ATO/ATRA protocol with the addition of two doses of IDA (50% compared to~     standard AIDA induction) for induction because of the anticipated need of adding~     anthracyclines to control hyperleukocytosis and to achieve long-term disease control in this~     high-risk APL population. This is followed by 4 cycles of ATO/ATRA consolidation therapy. As~     in the APL0406 study for low/intermediate-risk patients the investigators expect less severe~     hematologic toxicity and treatment-related mortality resulting in an improved outcome for~     patients in the experimental arm. Furthermore, from the start of consolidation, these~     patients (in contrast to the standard arm) can be treated on an outpatient basis, which is~     also considered to be associated with an improved quality of life. The study will be~     conducted as a European intergroup study.~   "
67140|NCT02688127|"~     This study evaluate role of tranexamic acid in reducing blood loss among pregnant women~     undergoing cesarean section because of placenta previa .Half of participants will receive~     tranexamia acid drug While the other half will receive placebo.~   "
67141|NCT02688114|"~     Radiofrequency ablation (RFA) is a mainstay of treatment for patients who have Barrett's~     esophagus (BE) with dysplasia. For unclear reasons, Barrett's esophagus recurs after~     successful RFA treatment in approximately 1/3 of patients. The aim of this study is to~     characterize the healing process of the esophageal mucosa, histologically and at the~     molecular level, after RFA for non-dysplastic and dysplastic Barrett's esophagus.~   "
67142|NCT02688101|"~     Multicenter, open-label, dose-escalation and pharmacokinetic study.~   "
67143|NCT02688088|"~     This study is known as a drug interaction study and is being done to see how abemaciclib~     may affect the blood levels of a drug mixture of commonly used drugs (caffeine, warfarin,~     dextromethorphan, and midazolam) when taken in combination with abemaciclib. Each participant~     will complete screening and four study periods, with the option to continue to receive~     abemaciclib in a safety extension phase. All participants will complete a safety follow-up.~   "
67144|NCT02688075|"~     The purpose of this study is to evaluate canagliflozin use in the treatment of type 2~     diabetes mellitus (T2DM) and generate evidence of its effectiveness, safety and~     patient-reported outcome (PRO) in a usual clinical practice in Canada.~   "
67145|NCT02688062|"~     The purpose of this study is to investigate the efficacy and safety of NeuroRegen Scaffold~     with bone marrow mononuclear cells (BMMCs) on neurological recovery following chronic and~     complete spinal cord injury, compared to the treatment of surgical intradural decompression~     and adhesiolysis only.~   "
67153|NCT02687958|"~     Cisplatin and Etoposide is the standard of care in NEC originating from the gastro-intestinal~     tract and lung, based on retrospective studies.~      Nevertheless the prognosis of this group of patients is still poor with median survival of~     less than 20 months.~      Everolimus is an mammilian target of rapamycin (mTOR) inhibitor that has been demonstrated to~     be active in patients with well and moderately differentiated primitive neuroectodermal tumor~     (pNET).~      Recently, the Investigators demonstrated that the mammilian target of rapamycin (mTOR)~     pathway is overexpressed in NEC.~      Based on the activity of Everolimus in the treatment of patients with well and moderately~     differentiated p-NET and on the evidence that even poorly differentiated forms express the~     pathway of m-TOR is conceivable that Everolimus could be active even in NEC.~   "
67154|NCT02687945|"~     The purpose of this study is to determine if outpatient physiotherapy results in improved~     and/or more rapid achievement of functional outcomes and quality of life in comparison to~     those patients who do not undergo outpatient physiotherapy after total hip arthroplasty~   "
67155|NCT02687932|"~     Functional MR is caused by adverse left ventricular remodeling after myocardial injury and~     associated with an increased incidence of heart failure and death. Because secondary~     functional MR usually develops as a result of LV dysfunction, diuretics, beta blockers,~     angiotensin-converting-enzyme (ACE) inhibitors or angiotensin receptor blockers (ARB), and~     aldosterone antagonists are given to patients with functional MR in line with the guidelines~     in the management of heart failure. However, functional MR appears to remain common despite~     use of these drugs and current medical treatment is usually insufficient for reducing MR or~     reversing the adverse LV remodeling. As LCZ696 is a dual-acting inhibitor of the~     renin-angiotensin-aldosterone system (RAAS) and neutral endopeptidase (NEP), LCZ696 has~     greater hemodynamic and neurohormonal effects than ARB alone. Investigators try to examine~     the hypothesis that LCZ696 is superior to ARB alone in improving functional MR in patients~     with LV dysfunction and functional MR.~   "
67156|NCT02687919|"~     This is a research study. The investigators are inviting participants to participate in this~     research study between the ages of 18-45, who have stable Relapsing-Remitting Multiple~     Sclerosis (RRMS), are able to walk 25 ft with/without an assistive device, and have none of~     the following: liver disease, kidney disease, diabetes, active heart disease, heart block or~     arrhythmias, bleeding disorders, concurrent diuretic use, anti-coagulation or anti-platelet~     use, psychosis or other psychiatric disorder likely to impact ability to comply with study~     procedures, any change in prescription medication for a mental health problem such as~     depression or anxiety in the last three months.~      The purpose of this research study is to determine whether or not a modified Paleolithic diet~     results in any change in health in persons with RRMS compared to usual care. The~     investigators define usual care as the typical or usual physician recommendations for the~     treatment of RRMS.~      The Paleolithic diet (or Paleo diet), also referred to as the caveman diet, Stone Age diet,~     and hunter-gatherer diet, is a modern nutritional plan based on the presumed ancient diet of~     wild plants and animals of ancestral humans during the Paleolithic era (a period of about 2.5~     million years duration that ended around 10,000 years ago with the development of~     agriculture). The diet consists mainly of fish, grass-fed pasture raised meats, vegetables,~     fruit, fungi, roots, and nuts, and excludes grains, legumes, dairy products, salt, refined~     sugar, and processed oils.~      To the investigators' knowledge, most neurologists prescribe medications that may reduce or~     prevent future disability, but few prescribe dietary modifications unless needed for other~     concomitant disease.~   "
67157|NCT02687906|"~     A single dose infusion of Vabomere (meropenem-vaborbactam) is being tested for dose-finding,~     pharmacokinetics, safety, and tolerability in pediatric subjects from birth to less than 18~     years of age with serious bacterial infections~   "
67158|NCT02687893|"~     Growing evidence provided by many observational studies has established a strong link between~     decreased sleep duration and poor glucoregulation. Sleep deprivation and poor sleep quality~     induce insulin resistance and decrease glucose tolerance in healthy individuals. However, the~     influence of poor sleep quality on glycemic control of patients with Type 1 diabetes mellitus~     (T1DM) is unknown. Persistent sleep deprivation among patients with T1DM has been reported,~     and this sleep loss can be attributed in part to nocturnal hypoglycemia. Nocturnal iatrogenic~     hypoglycemia is a limitation of current intensive insulin therapies. Although severe~     hypoglycemia is associated with adverse events such as seizures and death, less severe~     nocturnal hypoglycemia has been linked to broad range of adverse consequences, both acutely~     and long term. Hypoglycemia stimulates the sympathetic nervous system as a stress response,~     leading to the stimulation of the hypothalamic-pituitary-adrenal axis (HPA). This results in~     a counter regulatory hormone cascade, which elicits an excessive cortisol secretion, which is~     known to cause sleep disturbance and could impair glucose homeostasis after the hypoglycemic~     event. The hyperinsulinemia in T1DM patients promotes HPA hyperactivity as well, which is~     also associated with impaired sleep quality by leading to sleep fragmentation, decreased slow~     wave sleep and shortened sleep duration. Sleep disturbances due to nocturnal hypoglycemia can~     exacerbate HPA axis dysfunction, adversely affecting the sleep-wake cycle.~      The goal of the study is to understand the impact of nocturnal hypoglycemia on sleep.~   "
67159|NCT02687880|"~     Many chemotherapy and radiation-containing regimens for cancer or prior to bone marrow~     transplantation can cause sterility in children and young adults. In addition, some human~     disease conditions (e.g., Klinefelter's) are associated with infertility. Semen~     cryopreservation is available as a fertility-preserving option for post pubertal boys and~     adult men, but many do not take advantage of this option due in part to lack of information,~     illness, and/or time constraints relative to their treatment plan. Currently, no~     fertility-preserving options are available for prepubescent boys who are not yet producing~     sperm. The primary objective of the proposed study is to 1) Optimize techniques for~     cryopreserving testicular tissue, 2) Assess malignant contamination in testicular tissues and~     3) develop methods to enrich spermatogonial stem cells and remove malignant contamination~     from testicular tissue. In addition, this study will process and cryopreserve tissue and/or~     cells for participating patients as a resource for future elective procedures to attempt~     fertility restoration.~   "
67160|NCT02687867|"~     To obtain a better understanding on the comparative effectiveness of dabigatran versus~     Vitamin K antagonist (VKA) for stroke prevention in patients with Non-valvular atrial~     fibrillation (NVAF) in a real-life setting.~   "
67162|NCT02687841|"~     Hospital acquired acute kidney injury is an important negative outcome predictor for~     hospitalized patients. Uremic toxins accumulated after a given renal insult. Some of these~     uremic toxins are protein bound and may accumulated after renal impairment, owing to both~     impaired filtration, and inflammation. Recent animal studies have reported that accumulation~     of uremic toxins, namely indoxyl sulfate and p-cresol, would down regulate endothelial~     progenitor cells and in turn affect renal recovery. Elimination of these protein bound uremic~     toxins with an activated charcoal would help restore endothelial function. We will conduct a~     double blinded randomized placebo controlled trial, which aims to determine that if oral~     activated charcoal will retard progression of AKI. Also, a panel of markers for endothelial~     function will also be determined.~   "
67163|NCT02687828|"~     This study evaluates the safety profile and effectiveness of adalimumab in Korean intestinal~     Behcet's disease (BD) patients in routine clinical practice.~   "
67164|NCT02687815|"~     This study will determine whether vitamin D3 prevents severe asthma attacks in children who~     have a serum vitamin D (25(OH)D) level <30 ng/ml and who are being treated with inhaled~     corticosteroids for asthma. Half the participants will receive vitamin D3 at a dose of 4,000~     IU/day, and the other half will receive placebo.~   "
67165|NCT02687802|"~     The objective of the study is to estimate the incidence of asynchrony and to assess its~     relationship with respiratory mechanics. This will be a prospective cohort study, including~     patients under invasive mechanical ventilation. Within 48h post intubation, the investigators~     will record the values of intrinsic positive end-expiratory pressure, pulmonary compliance~     and resistance. Participants will be followed up from intubation to mechanical ventilation~     liberation. The investigators will register clinical signs of asynchrony and record~     ventilator waveforms continuously and quantify patient-ventilator asynchrony. The~     investigators will calculate the total asynchrony index (AI) and of each asynchrony type~     (ineffective triggering, double triggering, auto triggering, short cycling and prolonged~     cycling). Participants will be followed up until hospital discharge.~   "
67166|NCT02687789|"~     Bacterial Vaginosis (BV) is a common infectious disorder and is characterized by a~     disturbance in the vaginal microbiological milieu. Anaerobic bacteria, such as Gardnerella~     vaginalis and Atopobium vaginae overgrow the physiologic vaginal flora which is dominated by~     Lactobacilli. BV can arise and remit spontaneously but often presents as a recurrent disease.~      New findings indicate that the presence of an adherent bacterial biofilm on the vaginal~     mucosa seems to be the reason for the recurrence of BV as well as the overgrowth condition by~     anaerobic bacteria. Biofilms are defined as a structured consortium of bacteria embedded in a~     matrix of extracellular polymeric substances (EPS).~      The purpose of this study is to achieve substantial results with respect to tolerability and~     safety, and to gain further knowledge on the clinical efficacy of Vaginal suppository WO3191,~     the investigation will be performed in a parallel-design, double-blind, randomised,~     controlled manner.~   "
67167|NCT02687776|"~     Observational cohort study examining the perioperative course of copeptin in patients~     undergoing elevated-risk surgery.~   "
67168|NCT02687763|"~     A prospective, multisite study to evaluate the Impact of Measles, Mumps, Rubella and~     Varicella ProQuad® vaccination in pediatric patients 6-24 months of age who are being~     considered and/or evaluated for any solid organ transplant (heart, liver or kidney)~   "
67169|NCT02687750|"~     Testing of a dual tuned proton/fluorine MRI radio frequency coil~      Images were collected from plastic fluorine phantoms taped to the upper thigh of health~     volunteers.~      This trial was performed as part of an application for a Health Canada Investigational Device~     Exemption (Protocol # 226949)~   "
67170|NCT02687737|"~     The prevalence of dysphagia may be as high as 22% in individuals over 50 years of age. There~     are few therapeutic options offered to these individuals. One more recent therapeutic option~     is Expiratory Muscle Strength Training (EMST), which has been used successfully to maintain~     or increase expiratory force generating pressures, cough function, and swallowing in a number~     of disease populations. Recently, the investigators have noted improvements in oral transit~     time during swallowing in individuals with Amyotrophic Lateral Sclerosis (ALS) that could~     potentially be attributed to improved base of tongue functioning and muscle activation.~      There has been one study that demonstrated that breathing training resulted in increased and~     prolonged submental (under the chin) muscle activation as evidenced by surface~     electromyography. However, no studies have investigated the activation of the tongue muscles~     during various swallowing and breathing exercises. A small needle electrode (fine wire EMG)~     is standard of care in diagnosing muscular diseases because it can determine amount of muscle~     recruitment for muscles throughout the body. This aim of this research study is to examine~     the effects of breathing exercises and swallowing exercises on tongue muscle activity in~     healthy adults.~   "
67171|NCT02687724|"~     GLM dose Optimisation to Adequate Levels to Achieve Response in Colitis (GOAL-ARC). A~     nationwide multi-centred randomised controlled trial (RCT) investigating the use of GLM dose~     adjustment in ulcerative colitis (UC). The primary objective is to ascertain if dose~     adjustment of GLM based on GLM drug levels and FCP levels results in higher response and~     remission rates than standard SmPC dosing.~   "
67172|NCT02687711|"~     Study is the first study after commercialization of brivaracetam. It is designed to collect~     real world information on the effectiveness of brivaracetam in patients with Partial Onset~     Seizure epislepsy who are treated in standard clinical practice.~   "
67173|NCT02687698|"~     Parkinson's disease concerns some defects in carbohydrates metabolism involved in the~     progress of the pathology. Ketogenic diet has been largely studied as treatment on~     drug-resistant epilepsy and other neurologic diseases, but there is little information on the~     impact of this kind of diet in clinical aspects of Parkinson's disease. The aim of our study~     is thus to evaluate the effect of a lipid and protein controlled diet on resting energy~     expenditure, body composition and symptoms in patients with Parkinson's disease.~   "
67174|NCT02687685|"~     SUMMARY: Human lactation is a simple, cost-effective strategy contributing to infant and~     maternal mortality control. Skin to skin contact (SSC), is an immediate postpartum period~     strategy that has proven to benefit the initiation and continuation of human lactation and~     decreased hospitalization during the first week of life. This study aims to determine the~     effect of the initiation of SSC at birth (immediate vs. early) in healthy, full term newborns~     treated at Universidad de La Sabana Clinic, on the duration of exclusive human lactation.~      Research question: What is the effect of immediate SSC at birth (immediate vs. early) on the~     duration of exclusive human lactation in full-term newborns treated at the Universidad de La~     Sabana Clinic?~      Methodology: A random blind clinical trial was performed in which full-term healthy newborns~     that are attended at the Universidad de La Sabana Clinic are included. The blind participants~     will be those persons measuring the results and analysing the data. The sample size is~     calculated for a type I error of 5%, a two tailed type II error of 20%, therefore estimating~     percentage losses of 30%; 150 infants were included per group. Randomization will be~     performed using permuted, size 6 blocks. Descriptive analysis will be conducted using central~     tendency and dispersion measurements. A bivariate analysis will be performed to determine~     which variables are associated with exclusive human lactation at 6 months. For continuous~     variables, the Student t- test will be used for independent samples or the Wilcoxon rank sum~     test, in case the assumptions of normality for the t-tests are not fulfilled. The assumption~     of normality will be evaluated with the Shapiro Wilk and Kolmogorov-Smirnov test. Categorical~     variables in contingency tables will be constructed, assessing independence between variables~     with the Chi-square test or Fisher's exact test when the assumption of the number of cases is~     not met by the cells in the contingency tables, times two. It will be calculated as a~     measurement of the effect of relative risk (RR) with confidence intervals; the adjusted~     measurements will be calculated using a multivaried regression Poisson model, variables with~     significant results will be used in the bivariate analysis and those with biological~     plausibility used for the adjustment. The analysis will be carried out for a two-tailed type~     I error level of 5%. The Stata 11 program will be used for the data analysis. An interim~     analysis will be performed upon submission of half of the expected events (106), setting~     limits for early termination of the trial according to the method proposed by Pampallona and~     Tsiatis (1994).~      Intervention: There will be 2 SSC randomization groups, early vs. immediate. After completing~     the neonatal adaptation process and according to the group assignment, it will proceed to~     leave the newborn with the mother in accommodation. Prior to discharge, the IBFAT scale will~     be applied. Monitoring will initially be performed with a face valuation between 3 and 10~     days of life, then monthly telephone calls for 6 months to verify the status of human~     lactation.~      Results: To determine whether early versus immediate SSC has an impact on the duration of~     exclusive human lactation.~   "
67175|NCT02687672|"~     This is a double-armed, Phase I/II trial aims to compare bone marrow and leukapheresis as~     sources for purified, autologous CD34+ and CD133+ stem cells (SCs), to be utilized in~     treatment of patients with chronic complete spinal cord injuries (SCI). The study focuses on~     the safety and efficacy of transplanting un-manipulated, autologous, purified stem cells into~     the injured spinal cords of patients.~   "
67176|NCT02687659|"~     Physical inactivity is a major public health issue. Prescription of physical activity appears~     necessary in some situation with cardiovascular risk. It is important to both qualify and~     quantify daily physical activity.~      The aim of this project is to evaluate the TEMIS system (based on a smart T-shirt)~     performance in 12 healthy subjects, wearing this system over the daytime during one week.~   "
67177|NCT02687646|"~     Sequential administration of MSCs obtained from adipose tissue is an effective and safe~     treatment for acute graft versus host disease refractory to first-line treatment. Furthermore~     the infusion of these cells produces a biological pattern in patients that relates to the~     clinical response.~   "
67178|NCT02687633|"~     The investigators are running an intervention study for young children with Tuberous~     Sclerosis Complex (TSC). The study will include free play-based behavioral intervention that~     may improve social and communication skills in children with TSC. Eligible families will have~     a child in the age range of 12-36 months, with a diagnosis of TSC. A parent must also be~     available to attend the weekly intervention sessions at UCLA.~      The intervention will focus on teaching caregivers skills to improve the social and~     communication outcomes of their children. The content of the intervention will be~     individually tailored to the child's developmental level. The intervention involves~     pre-assessments, an intervention period of daily 60 minute sessions for 10 days, followed by~     weekly 60 minute sessions for 10 weeks, and post-assessments. The classroom can have up to 3~     parent-child dyad and the curriculum focuses on improving social-communication and play~     skills.~   "
67179|NCT02687620|"~     The purpose of this prospective cohort study is to evaluate the influence of serum drug~     levels and development of anti-drug antibodies on clinical response to anti-TNF agents in~     ankylosing spondylitis(AS) treatment. Secondary aims are to assess the demographic, clinical~     and laboratory variables associated with the development of anti-TNF drug antibodies at~     baseline or disease course and to reveal the impact of anti-drug antibodies on long-term~     efficacy or safety in particular drug survival in AS patients treated in daily clinical~     practice.~   "
67180|NCT02687607|"~     An observational non-randomized, multi-center, prospective assessment of the clinical utility~     of the WEB Aneurysm Embolization System in subjects with ruptured intracranial aneurysms~     deemed appropriate for endovascular treatment. The population being treated in this Registry~     is a subset of the CE marked indication.~   "
67181|NCT02687594|"~     An oral highly potent P binder Velphoro is a mixture of polynuclear iron(III) oxyhydroxide,~     sucrose, and starches. It was well tolerated in the clinical development program. The~     approved indication in the European Union (EU) is to control serums phosphorus (sP) levels in~     adult CKD (Chronic kidney disease) patients on HD (Haemodialysis) or PD (Peritoneal~     dialysis).~      It is of major interest to observe the drug in daily use outside of controlled trial~     settings. The Marketing Authorisation Holder wishes to obtain further systematic data within~     a non-interventional study to investigate short and long-term safety.~      Effectiveness and Treatment adherence during real-life use will be evaluated.~   "
67182|NCT02687581|"~     This study is designed to evaluate the effectiveness of a novel amblyopia treatment -~     Intermittent occlusion therapy (IO-therapy) glasses (AmblyzTM) in treating severe amblyopia.~      Children ages 3 to 8 years with severe amblyopia (visual acuity of 20/100 to 20/400 in the~     amblyopic eye) will be enrolled and randomized into two groups: 1) standard 6-hour patching~     group or 2) 12-hour IO-therapy glasses group.~   "
67183|NCT02687568|"~     Endoscopic examinations and particularly long-lasting interventions can be uncomfortable for~     patients. Pain and vasovagal reactions are common. Therefore, the implementation is generally~     recommended under sedation and also carried out in practice here.~      The vital signs monitoring to avoid complications is dictated by current national guidelines.~     Necessary measures of monitoring include pulse oximetry and blood pressure measurements. In~     patients with severe heart disease an ECG recording should be used additionally. Moreover,~     the guidelines require that the sedation is clinically monitored continuously to avoid an~     unwanted anesthetic stage. Such evaluation, however, is often difficult under clinical~     conditions and even counterproductive, since a constant response and tactile stimulation of~     the patient (to check clinically the depth level of sedation ), interrupts endoscopic complex~     intervention. However, clinical most relevant aspect is the avoidance of unrecognized~     transition of patients from the stage of deep sedation in an anesthetic stage.~      Current recommendations do not take into account new study results from a gender perspective,~     which showed that women and men need a different wake-up time using the EEG derivation means~     by using the Narcotrend after total intravenous anesthesia, which may be due to different~     total doses of sedatives needed. However, the research group has been demonstrated in a~     previous study that most likely caused by the use of EEG monitoring (Narcotrend) an effective~     adaptation of sedation, in particular a more rapid recovery time by a lower dose of the~     administered sedative for a continuous sedation stage D0-D2 endoscopic retrograde~     cholangiopancreatography-(ERCP).~      In the presented study the investigators evaluate the extent of gender differences in the~     wake-up time after sedation with propofol during colonoscopy when using EEG monitoring.~   "
67184|NCT02687555|"~     The purpose of this study is to determine whether a computerized training, Cognitive Bias~     Modification targetting appraisals (CBM-App), can reduce dysfunctional appraisals of trauma~     in patients with Post-Traumatic Stress Disorder (PTSD), compared to a control condition.~     Other outcomes measured include symptoms of PTSD and trauma-relevant dysfunctional~     cognitions. Participants are recruited from inpatients with PTSD admitted to the Clinic for~     Psychosomatic Medicine and Psychotherapy, LWL University Clinic of Ruhr University of Bochum.~   "
67185|NCT02687542|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of PF-06649751~     in Parkinson's disease patients who experience motor-fluctuations.~   "
67186|NCT02687529|"~     To compare the positivity rate of the investigational assay to the currently approved~     QuantiFERON-TB Gold In-Tube assay.~   "
67187|NCT02687516|"~     This study aims to evaluate the effectiveness of Family-based behavioral social facilitation~     therapy (FBSFT) in the treatment of severe obesity in children and adolescents compared to~     treatment as usual (TAU). The FBSFT condition includes 17 weekly family-based treatment~     sessions at the hospital obesity clinic followed by monthly follow-up sessions with their~     local nurse and follow-up sessions at the hospital every third month for 2 years. The~     treatment targets both child and parent life-style; eating habits, physical activity,~     sedentary activity and sleep habits. Behavior modification techniques are employed; such as~     self-monitoring, goal setting, reward systems, problem solving and stimulus control. In~     addition, FBSFT focuses on facilitating lifestyle change across different settings (family,~     friends, school and community) and harnessing social support for healthy habits, which is~     considered important for long-term weight control. The TAU condition involves an assessment~     day with the multidisciplinary team (pediatrician, dietician, physical therapist and~     psychologist) at the hospital obesity clinic. Further a session with the nurse at the~     hospital clinic making a plan for behavioral lifestyle changes followed by monthly follow-up~     sessions with their local nurse and follow-up sessions at the hospital clinic every third~     month for one year.~      SAMPLE AND STUDY DESIGN. The sample will consist of children and adolescents (aged 8-16)~     referred to the Obesity Outpatient Clinic at Haukeland University Hospital. Criteria for~     admission to the clinic is an (IOTF) isoBMI of > 35, or a isoBMI > 30 with obesity related~     co-morbidity. Based on current clinic data, estimations suggest that about 60 families of~     children with severe obesity will be referred to the Obesity Outpatient Clinic every year and~     be offered treatment. Recruitment will start in February 2014 and will continue in 2015 and~     2016. After consenting to participation and completion of the initial assessments the~     families will be randomized to either FBSFT or treatment as usual (TAU). After one year the~     families randomized to TAU will be offered the FBSFT treatment. Measurement points for the~     most important outcome measures will be pre-treatment, post-treatment (at approximately 6~     months), at 12 months, 18 months and 24 months.~      OUTCOME VARIABLES. Anthropometrical measures: Height, weight and waist-circumference,~     DXA-scans and bio-impedance measurements for determining the distribution of fat and muscle~     tissue. Physiological measures: Blood samples will be drawn in the morning after an overnight~     fast. Including measurements of total-cholesterol, HDL, LDL, TG, ASAT, ALAT, gamma-GT,~     bilirubin, creatinin, HbA1c and fasting insulin, c-peptide and glucose, TSH, fT4, CRP.~     Cortisol measurements from saliva and urine. Measurement of bloodpressure. Food records: The~     parents will be instructed to help their children to keep a diary of food and beverage intake~     for five days. They will use an electronic kitchen scale to weigh the food. Physical~     activity: Physical activity and sleep will be measured by using accelerometers. Psychological~     measures: The Child Behavior Checklist (CBCL) is a 138-item rating scale assessing behavioral~     and emotional symptoms in children/youth. Children's Depression Inventory (CDI). CDI is a~     27-item self-report test assessing symptoms of depression in children (7-17 years).~     Self-Perception Profile for Children (SPPC). SPPC is a self-report measure of self-perception~     in children aged 8 to 14 years. The Dutch Eating Behavior Questionnaire Child version (DEBQ)~     is a measure of disturbed eating patterns in children and youth. The Youth Eating Disorder~     Examination-Questionnaire (YEDE-Q) is a self-reported measure of eating patterns and eating~     disorder psychopathology. OTHER MEASUREMENTS INCLUDED. The Parenting Scale (PS) is a 30-item~     questionnaire designed to measure different parental disciplines with children/youth. The~     scores on three sub-scales are calculated - Laxness, Overreactivity and Verbosity. The~     Barriers to Treatment Participation Scale (BTPS). The 44-item scale is developed and~     validated to address drop-out from treatment with out-patient psychological treatment of~     children and adolescents. Child and parent acceptability of the treatment will be measured by~     the FBSFT Acceptability Questionnaire.~      STUDY AIMS:~        1. To evaluate the effect of FBSFT compared to TAU for treatment of severe childhood and~          adolescent obesity in an ordinary health care setting on BMI, BMI SDS, body composition,~          cardio-metabolic health, eating habits, physical activity as well as psychological~          well-being.~        2. To identify predictors of treatment success and treatment drop-out with a focus on~          family variables and mental health.~        3. To evaluate treatment (FBSFT) implementation and treatment acceptability for children,~          parents and health care workers and experienced barriers to treatment, and how these~          factors influence children's and parents' treatment response.~   "
67188|NCT02687503|"~     Probiotics are microorganisms that are believed to provide health benefits when consumed. The~     term probiotic is currently used to name ingested microorganisms associated with beneficial~     effects to humans and animals. Probiotics are popularized in the lay literature for many~     different clinical problems. They have been studied in infants and children as a preventive~     or treatment for a variety of infections. Studies on the medical benefits of probiotics have~     yet to reveal a cause-effect relationship, and their medical effectiveness has yet to be~     conclusively proven for most of the studies conducted thus far. The putative benefit of~     probiotics in the prevention of infection relates to potential benefits to the innate and~     adaptive immune systems of infants.~      The goals of this investigation are to study immune system cell function and microbiome in~     children who are taking probiotics.~      To accomplish this goal, we propose a pilot study for which we will obtain blood and~     nasopharyngeal and stool samples prior to and post probiotic use in children greater than 12~     months-36 months over a 27-38 day period~   "
67190|NCT02687477|"~     This project is focused on the treatment of severe obstructive sleep apnea with pulmonary~     artery denervation (PADN). Although it has now been proved that continuous positive airway~     pressure (CPAP) is the primary treatment for obstructive sleep apnea, on the other hand,~     there is evidence that 25 to 50% of patients can not tolerate CPAP.~      The investigators previously reported the safety and efficacy of pulmonary artery denervation~     (PADN) for treatment of pulmonary hypertension. Excessive sympathetic activation play an~     important role in the occurrence and development of OSA and cause cardiovascular events. It~     is worth evaluating the feasibility and tolerance of introducing PADN at the severe stage of~     obstructive sleep apnea. Therefore, the purpose of our study is to evaluate the safety and~     feasibility of PADN in the treatment of severe OSA.~   "
67191|NCT02687464|"~     Rationale and Aim: The standard treatment for acute appendicitis in children is appendectomy.~     An increasing body of evidence from the adult literature suggests that acute appendicitis may~     be treated effectively with antibiotics alone, avoiding the need for surgery. The aim of this~     study is to investigate the effectiveness of non-operative treatment of acute appendicitis in~     children.~      Study design: Pragmatic, parallel-group, unmasked, non-inferiority multicentre randomized~     controlled trial (RCT).~      Patient allocation: Children will be randomly allocated (age 5-16 years) with a diagnosis of~     acute appendicitis to either laparoscopic appendectomy or treatment with antibiotics.~     Randomization will be performed using stratification to ensure equal distribution between~     groups of presenting clinical and demographic features that may influence outcome including~     gender, duration of symptoms and center.~      Interventions: One group of children will undergo laparoscopic appendectomy that is the~     current standard treatment for children with acute appendicitis. The other group will be~     treated with intravenous antibiotics. A treatment pathway specifically designed for this~     study will be used.~      Primary Outcome: To be meaningful to parents of, and clinicians treating, children with acute~     appendicitis, the primary outcome is treatment failure defined as: (i) any additional~     intervention related to appendicitis requiring general anesthesia within 1 year of~     randomization (including recurrence of appendicitis after non-operative treatment, which we~     will treat with appendectomy) or (ii) negative appendectomy. Secondary outcomes are: (i)~     complications; (ii) time to discharge following randomization; (iii) number and duration of~     hospital admissions.~      Sample size and data analysis: The proposed RCT has a 20% non-inferiority margin to test the~     null hypothesis that treatment with antibiotics is inferior to appendectomy. Based on data~     from collaborating centers and a pilot study that we have performed, we expect recruitment of~     978 children in total (90% power) over 19 months allowing for drop out. Follow-up will be for~     12 months.~   "
67192|NCT02687451|"~     The purpose of the study is to evaluate the efficacy, tolerability, safety and~     pharmacokinetics of Oxymorphone HCl as an analgesic for acute moderate to severe~     post-operative pain in pediatric subjects.~   "
67193|NCT02687438|"~     Report on the technical feasibility and outcomes of in-office placement of PROPEL or PROPEL~     mini implants immediately following ethmoid sinus surgery~   "
67194|NCT02687425|"~     The purpose of this study is to assess the safety and efficiency of adding pioglitazone to~     chronic phase chronic myelogenous leukemia patients having received imatinib mesylate who~     have acquired a stable molecular response but not complete molecular response.~   "
67195|NCT02687412|"~     Fast-track surgery (FTS) pathway, also known as enhanced recovery after surgery (ERAS), FTS~     is a multidisciplinary approach aiming to accelerate recovery, reduce complications, minimize~     hospital stay without an increased readmission rate and reduce healthcare costs, all without~     compromising patient safety. It has been used successfully in non-malignant gynecological~     surgery, but it has been proven to be especially effective in elective colorectal surgery.~     However, no consensus guideline has been developed for gynecological oncology surgery~     although surgeons have attempted to introduce slightly modified FTS programmes for patients~     undergoing such surgery. NO randomised controlled trials for now.~      The advantages of fast-track most likely extend to gynecology, although so far have scarcely~     been reported. There is a existing research showed FTS in gynecological oncology provide~     early hospital discharge after gynaecological surgery meanwhile with high levels of patient~     satisfaction.~      The aim of this study is to identify patients following a FTS program who have been~     discharged earlier than anticipated after major gynaecological/gynaecological oncologic~     surgery and analyze the complication after surgery.~   "
67196|NCT02687399|"~     The purpose of this study is to determine the haemostatic efficacy of TT-173, reducing the~     total blood loss associated with the total knee arthroplasty.~   "
67197|NCT02687386|"~     This is an open-label, sequential dose exploration study of single agent EEDVSMit~     administered by intravenous (IV) infusion twice weekly, followed by weekly maintenance~     dosing, in children with recurrent/refractory solid or CNS tumours.~   "
67198|NCT02687373|"~     This study will be conducted in Siaya County in Nyanza Province, western Kenya. Healthy~     children aged 5 months through 9 years of age living within approximately 10 km of the study~     clinic(s) (Siaya County Referral Hospital, or Wagai dispensary, a government health facility~     in Wagai division) will be eligible for participation in Part 1; healthy infants aged 5~     months - 12 months inclusive will be eligible for Part 2.~   "
67199|NCT02687360|"~     Neuropathic pain is difficult to treat and is associated with the development of mood and~     substance use disorders. Most medications are only moderately effective, and deep brain~     stimulation is being used to treat sever chronic neuropathic pain. However, this requires~     brain surgery. The goal is to investigate the use of transcranial magnetic stimulation (TMS)~     directed at the medial prefrontal cortex and anterior cingulate for this disorder. These~     brain regions are in the prefrontal cortex, and research from deep brain stimulation studies~     indicated that stimulating this region may help treat pain. This is a pilot study to~     investigate the use of transcranial magnetic stimulation (TMS) directed at the regions in the~     prefrontal cortex using the H7 coil, which was developed to reach these deeper brain~     structures. While previous studies have investigated rTMS for pain, none, have used this coil~     to target these brain regions. This study will investigate active vs sham treatment in~     chronic pain participants.~   "
67200|NCT02687347|"~     The research hypothesis of this study is: In patients with moderate to severe cancer related~     pain, the addition of low dose methadone to an existing opioid significantly reduces pain~     severity compared to low doses morphine.~   "
67201|NCT02687334|"~     The aim of this study was to investigate the changes of cerebral oxygen saturation (rSO2)~     during anesthesia induction.~   "
67202|NCT02687321|"~     To evaluate and to compare the effectiveness of CA-125 and HE4 serum levels in epithelial~     ovarian cancer (OC) in follow-up in terms of time to detection of elevation after the end of~     the first line treatment. To evaluate the lead-time of the rise of marker levels before~     epithelial OC recurrence diagnosis by Computed tomography (CT) imaging method. To evaluate~     the appropriate HE4 cut-off value for follow-up of patients after the treatment of ovarian,~     Fallopian tube and primary peritoneal cancer.~   "
86227|NCT02438397|"~     the study objective: to explore the efficacy of acarbose and metformin on glucose~     fluctuations as add on therapy in type 2 diabetes patients inadequately controlled with~     premix insulin.~   "
67203|NCT02687308|"~     Prospective randomized study performing open anterograde anatomical radical retropubic~     prostatectomy (RRP2A) using the same technique of minimally invasive surgery described by the~     Pasadena consensus for the procedure assisted by robot, compared with the anatomical radical~     prostatectomy technique described by Patrick Walsh (RRP). Recent studies have shown benefits~     in the minimally invasive surgical techniques approaches, laparoscopic radical prostatectomy~     (LRP) and, more recently, robot-assisted radical prostatectomy (RARP). These minimally~     invasive techniques were associated with advantages in complications, like intraoperative~     bleeding, transfusion rates and in earlier recovery of important genitourinary functions such~     as urinary continence and penile erection. But still has not been demonstrated conclusively~     advantages as oncological control and it is believed that there are about 200 to 250 cases of~     learning curve so that the rates of complications and positive surgical margins become stable~     and similar to the open radical prostatectomy. These facts associated with the high cost of~     robotic technology still have limited the generalization of this approach in many developing~     countries such as Brazil. While the majority of studies made by comparing the radical~     prostatectomy (RP), robot X laparoscopic X open, show a slight advantage in the first two,~     there is a significant bias in these studies, which is that the surgical technique used in~     each procedure differs significantly from minimally invasive and open surgical techniques.~     The evolution of minimally invasive radical prostatectomy was based on an entirely different~     anatomical benchmark of that described by Patrick Walsh. While robotics and laparoscopic~     techniques dissect the prostate, bladder neck and the neurovascular bundle in an antegrade~     way, from bladder neck to the apex, the Walsh RRP technique is completely different in~     several ways, the dissection is made from prostatic apex to the bladder neck, so the~     retrograde direction, the posterior layer of Denonvilliers' fascia, is always included with~     the specimen, and urethrovesical anastomosis, usually performed with multifilament~     interrupted suture, only for indicating the major differences. The RRP2A will be performed by~     incision (open surgery) and will be compared with the anatomical radical prostatectomy~     technique described by Patrick Walsh RRP, and performed by the same surgeons.~   "
67204|NCT02687295|"~     Objective:~      The purpose of this study was to investigate the possible effects of green-plant thylakoid~     supplementation to a restricted diet intervention study in overweight to obese men.~      Methods:~      Overweight-obese men (BMI 25 - 35) were treated to a 30 E% restricted diet for one month,~     followed by one month of stabilization. Then they were divided in two treatment arms of one~     month each; one thylakoid-enriched diet (n=10) and one control diet (n=10). Body measurements~     and blood samples were taken throughout the study.~   "
67205|NCT02687282|"~     Mallampati class change has not been well evaluated during the cesarean delivery. Various~     factors regarding to cesarean delivery might influence this changes. The aim of this study~     was to evaluate the Mallampati class before and after cesarean delivery and to identify~     predictive factors of the changes..~      Study Type: Observational Cross-sectional study~   "
67206|NCT02687269|"~     Despite surgical and medical innovation have reduced mortality rates in cardiac surgery, the~     disease severity and operative procedural complexity have increased and morbidity rate is~     still high. Ischemia-reperfusion (I/R) injury, redefined in cardiac surgery~     post-cardioplegic injury (2) as a whole of ischemia-reperfusion, cardiopulmonary bypass and~     surgical trauma, has been recognized as a significant contributor to mortality and morbidity.~     I/R injury is classified as reversible or irreversible. Reversible injury includes~     arrhythmias, edema, vascular dysfunction and contractile stunning expressed as low output~     syndrome without cell death and without apparent signs of infarction or other serum injury~     markers. Irreversible reperfusion injury includes apoptosis and necrosis. I/R injury is a~     complex process associated with increase of radical, oxidant and cytokines production,~     complement and neutrophil activation and endothelial activation leading to microvascular~     dysfunction and deterioration of coronary flow reserve. In the hypoxic heart increase~     anaerobic lactate production, K+ efflux and membrane depolarization. The intracellular Na+~     concentration rises as a consequence of slow Na+ channels inactivation and the induction of~     voltage-gated Na+ channel late current component (late INA). Intracellular Na++ accumulation~     enhanced activity of reversed-mode Na+-Ca++ exchanger causing intracellular Ca++ overload and~     ventricular dysfunction. Therefore inhibition of late INA has been shown to be~     cardioprotective. Ranolazine, an FDA-approval antianginal and anti-ischemic agent, high~     selective blocker of late INA, inhibits the late sodium current in myocardial ischemia,~     decreases Na+ and Ca2+ overload and improves left ventricular function in experimental animal~     models. For this reason it was also adjuncted to cardioplegia improving diastolic function in~     isolate Langerdoff-perfused rat hearts. The authors test the hypothesis that ranolazine~     improve myocardical protection in patients undergoing coronary artery surgery with~     cardiopulmonary by-pass (CPB).~   "
67207|NCT02687256|"~     This is a blinded cross-over study to see if extended wear insulin infusion sets can prolong~     insulin infusion set wear up to 7 days in adults with Type 1 Diabetes.~   "
67208|NCT02687243|"~     Preoperative anxiety (PA) affects up to 5 million children in North America each year and is~     associated with adverse medical, psychological, and behavioral effects. Children who are~     highly anxious often require more medications during surgical procedures and take longer to~     recover. While many attempts have been made to reduce PA in children, existing interventions~     are limited by their expense and time intensive nature. Thus, the current lack of effective~     and efficient methods of reducing anxiety in children before and after surgery has prompted~     us to develop and propose to test a new intervention. The investigators have developed a~     novel,interactive tablet based Virtual Reality program, StoryTelling Medicine (STM), to help~     reduce anxiety in children undergoing elective surgery, and its associated negative effects.~      STM is an age appropriate, customizable program to prepare children for complex surgical~     procedures by guiding them through the hospital settings. The investigators will examine if~     STM is effective in reducing PA and its adverse effects in children undergoing surgery. If~     effective, STM has the potential to improve children's and families' surgical experiences,~     and reduce health problems in the hospital setting and beyond.~   "
67209|NCT02687230|"~     Open label, nonrandomized, dose-escalation trial of MVT-2163 and MVT-5873 used in performing~     PET scans. The study is designed to determine the best time and dose of these agents that~     result in the best PET image of a tumor. Subjects will be seen on days 1, 2, 4, and 7 for~     imaging and a clinical assessment. The last study visit is on day 28.~   "
67210|NCT02687217|"~     The study evaluates the role of supplemental hyper-oxygenation given perioperatively on wound~     site infection after appendectomy. Half of the patients received ≥50% oxygen and half of them~     received no oxygen during the surgical procedure.~   "
67223|NCT02687048|"~     Falls have significant consequences for older adults, including fracture, disability, and~     death (1). Risk factors for falls include both impaired physical and cognitive function (1).~     Thus, older adults with chronic stroke are at significant risk for falls (2).~      Exercise is an evidence-based approach for reducing falls risk, even among those who are~     living with stroke-related impairments (3,4). More recently, mindfulness based meditation is~     gaining recognition for its positive impact on both physical and cognitive health (6,7).~     Thus, the investigators hypothesize that combining exercise with mindful meditation may be~     greater impact on falls risk reduction as compared with exercise alone. To begin exploring~     our hypothesis, we will conduct a 12-week proof-of-concept study among 20 older adults with~     chronic stroke (i.e., suffered their first clinical stroke > or = 12 months prior to study~     entry). Participants will be randomly allocated to either: 1) exercise; or 2) exercise +~     mindfulness based meditation. Outcomes will include measures of mobility, balance, and~     cognitive function.~        1. Rubenstein, L.. Falls in older people: epidemiology, risk factors, and strategies for~          prevention. Age and Ageing 2006; 35-S2: ii37-ii41. doi:10.1093/ageing/afl084~        2. Tyson et al. Balance disability after stroke. Physical Therapy January 2006: 86~          (1):30-38~        3. Thomas S, et al.Does the 'Otago Exercise Programme' Reduce Mortality and Falls in Older~          Adults?: A Systematic Review and Meta-analysis. Age Ageing. 2010; 39(6): 681-687.~        4. Verheyden G, et al. Interventions for preventing falls in people after stroke. The~          Cochrane database of systematic reviews, 2013(5).~        5. Baer R. Mindfulness Training as a Clinical Intervention: A Conceptual and Empirical~          Review. Clinical Psychology: Science and Practice 2003; 10(2): 125-143.~        6. Grossman P, et al. Mindfulness-based stress reduction and health benefits. A~          meta-analysis. Journal of Psychosomatic Research, 2004;57(1) 35.~   "
67211|NCT02687204|"~     Blood clots that form in the extremities (deep venous thrombosis) and lungs (pulmonary~     embolus) are feared complications of reconstructive surgery. One in ten patients with~     symptomatic pulmonary embolus will be dead in 60 minutes. Patients with deep venous~     thrombosis can develop the post-thrombotic syndrome, known to be a major driver of poor~     quality of life. These phenomena, broadly known as venous thromboembolism (VTE), have~     substantial downstream ramifications, and the US Surgeon General and the American Society of~     Plastic Surgeons (ASPS), among others, have underscored the importance of VTE prevention in~     surgical patients. Reconstructive surgery, most commonly performed to fix traumatic injuries~     or defects after cancer excision, often involves borrowing tissue from adjacent or distant~     areas on the body; reconstructive surgery patients can routinely have surgical injury~     involving 20% or more of their total body surface area. Injury and resultant inflammation are~     known to increase metabolism of certain drugs, including those used to prevent VTE after~     surgery.~      Enoxaparin is a blood-thinning medication that decreases likelihood of blood clot formation.~     Previous research has shown that reconstructive surgery patients who are given enoxaparin~     after surgery are less likely to develop VTE. However, despite receiving of a standard dose~     of enoxaparin, many patients still develop this life-threatening complication. The~     investigators believe that patients metabolize enoxaparin differently based on the degree of~     surgical injury created during reconstruction, and seek to critically examine enoxaparin~     metabolism in reconstructive surgery patients. The proposed research will evaluate how~     enoxaparin affects the blood based on standard, ASPS-recommended dosing after reconstructive~     surgeries; the investigators will also examine whether the extent of surgical injury alters~     metabolism as well. Enoxaparin effectiveness will be tracked using anti-Factor Xa (aFXa)~     levels. If subtherapeutic aFXa levels are observed, the study will also design, implement and~     test a clinical enoxaparin dose-adjustment protocol to achieve appropriate post-operative~     aFXa levels. Further research based on these data will examine reduction in VTE risk when~     aFXa-driven enoxaparin dosing is used.~   "
67212|NCT02687191|"~     This study employs a modified continual reassessment method (mCRM) design to estimate the~     maximum tolerated dose (MTD) of PF-05230907, defined as a target toxicity rate of 15% based~     on treatment emergent thromboembolic and/or ischemic events (TIEs). The mCRM design utilizes~     Bayesian methodology to continuously learn the dose-toxicity relationship, which is~     characterized by a parametric model.~      Subjects with a diagnosis of ICH (determined by computed tomography) will be enrolled in~     cohorts of 3. The total length of time planned for study participation is approximately 3~     months; 6.0 hours for screening, a single dose administration with a 4-day minimum hospital~     confinement period and follow-up visits through Day 91.~      Severity of adverse events (AEs) and serious adverse events (SAEs) will be graded according~     to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)~     version 4.03. All subjects who receive PF-05230907 are evaluable for TIEs. The determination~     of MTD using mCRM modeling will be based on TIEs which occur through 7 days post-dose (Day~     8).~   "
67213|NCT02687178|"~     To evaluate the efficacy on blood pressure reduction, safety and tolerability of two~     different dosages of canrenone as add-on therapy in patients already treated with Angiotensin~     Converting-Enzyme Inhibitors (ACE-I) or Angiotensin II Receptor Blockers (ARBs) and diuretics~     at the maximum dosage.~   "
67214|NCT02687165|"~     This study will investigate (a) neural and immune mechanisms underlying chronic pain in PTLS~     by comparing a group of PTLS patients and healthy participants on brain imaging, sensory, and~     immune markers; and (b) assess change in pain, brain imaging (fMRI and MRS), sensory, and~     immune markers in response to a combination of SNRI and glutamatergic treatment for chronic~     pain in PTLS (Milnacipran and D-cycloserine).~   "
67215|NCT02687152|"~     The present project is designed to test the hypothesis that arginase contributes to~     microvascular endothelial dysfunction in patients with type 2 diabetes and microvascular~     complications.~   "
67216|NCT02687139|"~     In this study the investigators aim to evaluate diagnostic utility of PSMA-targeted~     18F-DCFPyL PET/CT in patients with renal cell carcinoma.~   "
67217|NCT02687126|"~     The purpose of the study is to evaluate the success rate using ultrasound as guidance during~     central venous cannulation in pediatric cardiac surgical patients.~   "
67218|NCT02687113|"~     The purpose of this study is to determine whether fusion technique of pre-radiofrequency~     ablation (RFA) cross-sectional imaging (CT or MR) and real-time ultrasonography would improve~     feasibility of RFA in patients with liver tumor in comparison with ultrasonography guidance~     alone.~   "
67219|NCT02687100|"~     The aim of the study is to test the effectiveness of a solutions of beclomethasone repeatedly~     instilled through the supraglottic line of the endotracheal tube on post-extubation airway~     disturbances related to tracheal intubation. The primary endpoint will be the decrease of the~     incidence of sore-throat 15 minutes and 12 hours after extubation. Secondary endpoints will~     regard the effects on hoarseness and cough.~   "
67220|NCT02687087|"~     The purpose of this study is to evaluate the clinical safety and effectiveness of Visco-ease~     dry mouth spray for the treatment of Radiotherapy Induced Xerostomia (RIX) in head and neck~     cancer patients.~      A parallel group double blind study design has been selected. The primary outcome is change~     in GRIX scores from baseline (visit 1) to end of treatment (visit 7). The primary outcome~     will be compared between Visco-ease and the placebo treatment.~   "
67221|NCT02687074|"~     Respiratory failure is the danger for the patients admitted in ICU, mechanical ventilation~     could save a lot of patients' life, however, it prolongs patients' ICU stay and hospital~     stay. High flow nasal cannula (HFNC) has advantages of PEEP effects, reducing dead space,~     increasing EELV and improving comfort, and it has been used to treat respiratory failure~     patients. In recent study, HFNC could improve mortality of respiratory failure patients with~     P/F<200mmHg in the subgroup. The investigators want to start a randomized controlled study to~     evaluate the effects of HFNC on the patients with respiratory failure.~   "
67222|NCT02687061|"~     The project aims to retrieve patients diagnosed with chronic hepatitis B (cHB) and hepatitis~     C (cHC) who are lost to follow-up.Data files of the Public Health System and microbiology~     laboratories will be explored for registered cases of cHB and cHC. Subsequently the~     investigators will compare the registered cases with the list of known cHB and cHC patients~     in hospital care. Patients lost to follow up will be informed and approached via either the~     Public Health Service (PHS) or their primary care physician. Identified patients will be~     invited for re-evaluation at the regional hepatitis centre (The North Western Hospital,~     formerly Medical Centre Alkmaar) to assess the current status of their chronic disease.~     Evaluation will be performed in accordance with (inter-)national guidelines, no extra~     interventions will be performed.~      After completion of re-evaluation, a final report will be made and send to both patient and~     primary care physician with recommendations for further follow-up.~   "
67224|NCT02687035|"~     The purpose of this trial is to determine the safety and effectiveness of the Edwards Edwards~     SAPIEN 3 transcatheter heart valve and delivery systems which are intended for use in~     patients with symptomatic, calcific, severe aortic stenosis.~   "
67225|NCT02687022|"~     Wavefront scans are a common form of diagnostic test applied in preparing patients for laser~     eye surgery. An optical map of the eye is created by wavefront scanning, and information from~     these maps is used to program lasers used to correct focusing errors in the eye. Here the~     investigators are comparing how repeatable measurements are with a new wavefront scanner and~     one that is already in widespread use.~   "
67226|NCT02687009|"~     This study evaluates the safety of Niclosamide in patients with colon cancer that are~     undergoing primary resection of their tumor. This is a phase I study with three dosage levels~     to determine the maximum tolerated dose (MTD).~   "
67227|NCT02686996|"~     The aim of this study is to determine whether carnosine supplementation in overweight/obese~     individuals can improve insulin secretion and/or insulin resistance by decreasing sub~     clinical inflammation.~      The investigators hypothesise that carnosine supplementation will reduce type 2 diabetes and~     cardiovascular risk factors by lowering chronic low-grade inflammation (CLI), oxidative~     stress, advanced glycation end products (AGEs), and advanced lipoxidation end products~     (ALEs).~      Aim :To determine the capacity of carnosine supplementation to decrease major risk factors~     for type 2 diabetes and cardiovascular disease and identify metabolic pathways involved,~     specifically by:~        1. Reducing diabetes risk (insulin sensitivity; secretory function and glucose tolerance)~        2. Improving cardiovascular risk factors (lipids; arterial (aortic) stiffness; central~          blood pressure (cBP); endothelial function).~        3. Decreasing the CLI, oxidative stress, AGEs, and ALEs, and increase detoxification of~          reactive carbonyl species (RCSs).~   "
67228|NCT02686983|"~     Infiltration of the greater occipital nerve (GON) with local anaesthetics and corticosteroids~     is a treatment option for cluster headache. Corticosteroids may be helpful in reducing the~     pain intensity and frequency in chronic migrtaine. This RCT is set up to assess efficacy and~     safety of sub-occipital steroid injections with local anesthetic in patients with chronic~     migraine.~   "
67229|NCT02686970|"~     The aim of this study is to adapt and validate to the Spanish the European Quality~     Questionnaire (EuroQ2) to evaluate families' experiences of quality of care for critically~     ill and dying patients in the ICU.~   "
67230|NCT02686957|"~     Obstetric fistula, also called vaginal fistula, is a serious medical condition which affects~     women in low income countries. Despite the strengthening of research on fistula, there is~     little data on the follow-up after fistula repair.~      The objective of this study is to analyse the factors associated with the recurrence of~     fistula and the outcomes of pregnancy following fistula repair in Guinea. It will target~     women who got a closed fistula at discharge after repair in 2012/2015 at three fistula repair~     sites supported by the Fistula Care Project in Guinea (Kissidougou Prefectoral Hospital, Labé~     Regional Hospital and Jean Paul II Hospital of Conakry).~      The outcomes of interest are fistula recurrence and pregnancy. The predictors of interest~     will include patient characteristics, fistula characteristics, the context of repair and the~     context of reintegration.~      Participants giving an informed consent after a home visit by the Fistula Counsellors who~     managed women during surgery will be interview at enrolment and every six month from~     inclusion. The study duration is estimated at 48 months (January 2012 to March 2016)~     including the retrospective part.~      A sample size of 364 women will estimate the recurrence of fistula with a plus/minus 2%~     margin of error (width of confidence interval is 4%) and 95% confidence interval and is~     sufficient to estimate the rate of pregnancy with a two-sided 95% confidence interval and 10%~     precision.~      The cumulative incidence rate of fistula recurrence will be calculated using Kaplan-Meier~     methods and the risk factor analysis will be performed using adjusted cox regression.~      For the outcomes of pregnancy, Pearson's Chi Square (χ2) will be used to compare proportions~     of pregnancy outcomes between potential predictors and logistic regression models will be~     used and associations will be reported as risk ratios with 95% confidence intervals.~      Analysis will be done using STATA version 13 (STATA Corporation, College Station, TX, USA)~     with a level of significance set at P<0.05.~   "
67231|NCT02686944|"~     The study is a prospective single armed, open label phase I study. Patients with advanced or~     metastatic GIST and tumor progression despite ongoing treatment with second, third or fourth~     line TKI treatment, and with at least one measureable tumor lesion, will be eligible for the~     study. A maximum of 12 patients will be included in this study. The patients will continue~     with TKI treatment until the 3 months follow up visit. If further tumor progression TKI will~     be withdrawn but if stable disease or objective response the patient will continue with TKI~     until progress. The investigational product Intuvax will be injected into a tumor lesion at~     two or three treatment occasions; day 1, 14 days (±3 days) after the first vaccination, and~     28 days (±3 days) after the second vaccination (patient 7-12 only). Intuvax will be injected~     in a viable part of the tumor, using ultrasound-guided or CT technique for correct~     administration.~   "
67232|NCT02686931|"~     Children with developmental disabilities and children's rehabilitation common case~     investigation: Long-term follow-up study.~   "
67233|NCT02686918|"~     The main of this study is to assess the feasibility of a patients follow-up visit receiving~     trastuzumab subcutaneous by Advanced Practice Nurse.~   "
67234|NCT02686905|"~     The objectives in this study are to provide information on the efficacy of transdermal~     supplement patches on treating nutrient malabsorption and deficiency in post-op bariatric~     patients, and to determine short-term body composition, HbA1c and fasting plasma glucose~     outcomes for patients after bariatric surgery.~   "
67235|NCT02686892|"~     This is a prospective, observational, multicenter, population-based incidence cohort study~     which will enroll cases of IBD (CD, UC, or indeterminate colitis) diagnosed in adults over 1~     year in Spain.~      In addition, each incident case that gave his/her informed consent, will be followed up for~     12 months to determine changes in phenotype or disease location, the need for~     immunosuppressive and biologic treatments, and the need for hospital admissions and surgery~     during the first year after diagnosis.~   "
67236|NCT02686879|"~     Hyperopia, also known as farsightedness, is a common type of refractive error where distant~     objects may be seen more clearly than objects that are near.~      Hyperopia is a known risk factor for amblyopia, (lazy eye), which may occur as a result of a~     squint (turn), or due to different levels of hyperopia between each eye (anisohyperopia).~      Hyperopia and anisohyperopia often persist into adulthood resulting in impairment to~     binocular vision. Current management involves prescribing spectacles or contact lenses to~     correct the hyperopia in each eye, usually as a lifelong intervention.~      In recent years there has been a great deal of interest in delaying progression of myopia~     (short-sightedness) by slowing down the growth of the eye using a particular type of contact~     lens termed a centre-distance multifocal design. There have been some encouraging results in~     this area to date.~      The proposed study here would explore the use of centre-near multifocal design contact lenses~     to encourage growth of the eye, thereby reducing hyperopia. There are three elements to the~     programme of research:~        1. The natural progression of axial growth and refractive error will be measured in~          hyperopic and anisohyperopic subjects aged between 5 and 19. In other words, the natural~          growth of the eye will be followed without any intervention~        2. As a paired eye control study anisohyperopes aged between 8 and 15 will be fitted with a~          centre-near multifocal design contact lens in their more hyperopic eye and a single~          vision contact lens in the fellow eye, if required. The progression of axial growth and~          refractive error will be measured and compared in each eye~        3. Subjects' aged between 8 and 15 with similar levels of hyperopia in each eye will be~          fitted with centre-near multifocal design contact lenses in each eye. The progression of~          axial growth and refractive error will be measured and compared to subjects in the~          natural progression study~   "
67303|NCT02685995|"~     Randomized two-arm study examining 90 day primary patency of two FDA-approved tunneled~     dialysis catheters.~   "
67237|NCT02686866|"~     Feeding optimization and nutritional assessment in patients with severe heart failure are~     challenging. The prevalence of cardiac cachexia may be underestimated by simple measurements~     of body weight and body mass index because many patients show relative reductions in muscle~     mass despite being of normal overall weight. Body composition measurement can be essential in~     chronic heart failure (CHF) patients to estimate sarcopenia. Chronic heart failure patients~     with cardiac cachexia have a mortality two to three times higher than noncachectic patients.~     Bedside body composition measurements can reveal developing cardiac cachexia hence can be~     useful in prevention.~   "
67238|NCT02686853|"~     The main purpose of this study is to observe the clinical effect of intrathecal~     administration of liposomal amphotericin B in Cryptococcal Meningitis without Acquired Immune~     Deficiency Syndrome (AIDS).~   "
67239|NCT02686840|"~     The aim of this work is to compare the effectiveness of vaginal versus sub-lingual~     misoprostol for medical treatment of first trimester missed miscarriage.~   "
67240|NCT02686827|"~     Low Vitamin D3 (VD3) levels have been reported to be associated with the risk of allergic~     diseases like asthma. VD3 has been demonstrated in vitro, ex vivo and in animal models to~     program the immune system towards anti-inflammatory immune responses. VD3 co-administered~     with allergen may be a promising adjuvant to improve the onset and efficacy of allergen~     immunotherapy (AIT). A clinical trial will be performed to compare the immune effects, the~     tolerability and safety of multiple doses of aVD3 analogue (registered for the intravenous~     route) administered by the subcutaneous (s.c.) route in subjects with allergic rhinitis and~     healthy controls.~      The overall aim is to provide additional (in vivo) support for the use of VD3 as an adjuvant~     in allergen-specific immunotherapy, on top of the existing pre-clinical evidence~     demonstrating that antigen-presenting cells educate the adaptive immune system towards an~     anti-inflammatory response when allergen is seen in the presence of VD3.~   "
67241|NCT02686814|"~     The purpose of this study is to evaluate the safety and effectiveness of the 17mm MDT-2215~     aortic valve bioprosthesis.~   "
67242|NCT02686801|"~     This study evaluates the perinatal factors influencing body composition at discharge in very~     preterm infants and the relationship between fat free mass and further neurocognitive~     development.~   "
67243|NCT02686788|"~     The purpose of this study is to assess the impact of TMP001 in the treatment of patients with~     relapsing-remitting multiple sclerosis (RRMS). Therefore the average total number of contrast~     enhancing lesions (CELs) on brain MRI scans at weeks 12, 16, 20, and 24 during treatment with~     TMP001 is compared to the average total number of CELs on brain MRI scans at week -4 and~     baseline in these patients .~      Based on promising preclinical results, the investigators assume a comparable effect of~     TMP001 on reduction of contrast-enhancing lesions as shown for other immunomodulatory~     substances in recent clinical studies.~   "
67244|NCT02686775|"~     The randomized trial evaluates whether assigning a patient coach to vulnerable lung cancer~     patients will empower these patients to participate in the treatment decision process, help~     patients navigate the health care system while undergoing treatment and adhere to cancer~     treatment and to recommendations for supportive care. Half of the participants will receive~     standard care and be offered a patient coach while the other half will receive standard care.~   "
67245|NCT02686762|"~     This is a multicenter, double-blind, randomized, placebo-controlled trial involving subjects~     with a diagnosis of definite NASH with fibrosis (excluding cirrhosis) as determined by the~     central histopathologist. Upon successful screening, subjects will be randomized to receive~     either emricasan 50 mg BID or emricasan 5 mg BID or matching placebo BID.~   "
67246|NCT02686749|"~     This study is a multi-center, randomized, unblinded, clinical trial. The objective is to~     determine if catheter-based atrial fibrillation (AF) ablation is superior to medical~     treatment in patients with impaired left ventricular (LV) function who have been diagnosed~     with symptomatic AF within the past 12 months.~   "
67247|NCT02686736|"~     The objective of this study is to design and evaluate an internet-based educational strategy~     to prevent sexual risk behaviors in Mexican adolescents. Methods: A field trial with one~     intervention and one comparison group, with ex-ante and ex-post measurements will be~     conducted in 2 public secondary schools. Adolescents between 14 and 15 years of age will~     participate. The intervention will be conducted in one school and the other school will serve~     as a comparison group, where investigators will observe the usual sexual education that the~     school provides. The intervention will be delivered through an internet web page; it includes~     four educational sessions that will be provided during a four-week period. The follow up will~     last three-months. The information on the study variables will be obtained through an~     internet-based self-applied questionnaire and collected on three occasions: when the~     adolescents enters to the study (baseline), once intervention is completed (at one month) and~     after three months of follow-up (at fourth month).~   "
67248|NCT02686723|"~     Comparison of two groups of subjets (ACL injury who return to sport) and control group~     non-injured about clinical and biomechanical data :~        -  clinical test~        -  functional test~        -  motion analysis of 2 sport exercises~        -  tibial translation~        -  isokinetic evaluation~   "
67249|NCT02686710|"~     Assessment of GSK-3beta contents in leukocytes in on-pump cardiosurgical patients receiving~     either volatile or intravenous anesthesia~   "
67250|NCT02686697|"~     This is a double-blind placebo-controlled trial to evaluate the effects of the combination of~     a cognition enhancing drug, i.e carnosine, with cognitive training in patients with~     schizophrenia. All participants will receive the same cognitive training sessions and will be~     randomised to either carnosine or placebo for the duration of the combined treatment period~     (2 weeks). Before combined training and carnosine/placebo, there is a two-week~     carnosine/placebo only phase to examine the effects of carnosine alone on functioning without~     training.~   "
67251|NCT02686684|"~     The primary aim of this study is to explore the effect of dimethyl fumarate on gray matter~     (GM) pathology, as measured by changes in diffusion-tensor imaging (DTI) of the thalamus in~     patients with relapsing multiple sclerosis (MS). The secondary objective of this study is to~     investigate the effect of dimethyl fumarate on evolution of microstructural changes in normal~     appearing white matter (NAWM), as measured by DTI.~   "
67337|NCT02685553|"~     The purpose of this study is to determine whether the use of Near-Infrared Technology can~     guide the laparoscopic resection of hypervascular neoplasms of the pancreas.~   "
67252|NCT02686671|"~     Shoulder pain is very common. People receive injections in their shoulder for their painful~     shoulder. However, investigators do not know which patient with shoulder pain responds best~     to an injection in the shoulder.~      Investigators plan to use a Pull Test where the researcher will pull on the arm and resist~     shoulder movement to investigate if it helps to determine which patients have better pain~     relief with the shoulder injection.~      The study will take place in Anchorage, Alaska. There will be two phases in the study. For~     each phase, the subjects will complete some questionnaires. Phase I Reliability Testing~     will test how consistent two licensed physical therapists are giving shoulder examination~     tests and the Pull Test. Phase II Pull Test will comprise shoulder examination findings,~     including the Pull Test, done before and after one shoulder injection performed as normal~     standard of care by a licensed physician.~      For Phase I of the study, up to 20 patients treated for shoulder pain will be recruited from~     Advanced Physical Therapy. For Phase II of the study, up to 100 patients with shoulder pain~     scheduled to have a shoulder injection will be asked by an investigator if they wish to~     participate in the study until a number of 30 subjects qualify for the study. Phase II of the~     study will include shoulder tests before and about 20 minutes after the injection and a 4- to~     7-day, as well as a 6-week, phone follow-up.~      Statistics will be used to analyze the data.~   "
67253|NCT02686658|"~     The objectives of this study are to evaluate the safety and efficacy of intravitreous~     administration of Zimura when administered in subjects with geographic atrophy (GA) secondary~     to dry age-related macular degeneration (AMD).~   "
67254|NCT02686645|"~     Interventional, single arm, single-centre trial to evaluate the effectiveness and safety of~     fecal microbiota therapy (FMT) in the investigators population.~   "
67255|NCT02686632|"~     Denture stomatitis (DS) is an oral biofilm associated inflammatory disease of the palatal~     mucosa. It is the most prevalent oral disease and the main indicator of poor oral health~     among denture wearers, affecting one-third of all complete denture wearers.~      The etiology of DS is multifactorial, with documented role of mechanical trauma, bacteria and~     fungi. Risk factors may include, poor oral hygiene and nocturnal use of dentures. However,~     the evidence is ambiguous, inconclusive and recurrence following routine antifungal therapy~     is common.~      The proposed study is a phase II clinical trial to evaluate the efficacy of palatal brushing~     in reducing the colony forming unit (CFU) count and clinical inflammation. The assessment of~     change in CFU count and clinical inflammation will be carried out at baseline, 3 months and 6~     months.~   "
67256|NCT02686619|"~     This multicentre, prospective, randomized, open-label study will compare the safety and~     efficacy of mycophenolate mofetil with delayed introduction of sirolimus and discontinuation~     of cyclosporine, with those of mycophenolate mofetil and long term continuation of~     cyclosporine in renal transplant recipients receiving daclizumab (Zenapax) as induction~     treatment and followed by 8 month treatment with corticosteroids. The anticipated time on~     study treatment is 12 months. Participants who will complete the initial 12-month study and~     who will provide written informed consent will be eligible to participate in a 60-month~     follow-up phase.~   "
67257|NCT02686606|"~     Patients with short bowel intestinal failure are recommended to aim for a diet high in energy~     and protein. Some patients have difficulties in achieving recommended intakes and additional~     nutrition may be provided by oral nutritional supplements. There is very little research~     completed on which is the best oral nutritional supplement for patients. The aim of the study~     is to see the effect different oral nutritional supplements have on your stoma or fistula~     output and levels of hydration.~   "
67258|NCT02686593|"~     The study aims to evaluate the efficacy of the regimen CLAM in relapsed or refractory AML~     when used as first salvage for patients to relapse or fail after standard treatment with~     daunorubicin/cytarabine induction.~   "
67259|NCT02686580|"~     This study is designed to assess the effectiveness of porcine cross-linked collagen paste for~     the treatment of patients with ano-rectal abscess with underlying cryptoglandular fistula in~     ano.~   "
67260|NCT02686567|"~     The rate of anastomotic leakage after laparoscopic anterior resection（LAR） for medium & low~     rectal cancer is still high. the transanal drainage tube (TDT) was thought to be useful for~     deduce the rate. There were several studies, but most of them were not randomized controlled~     trial (RCT) studies. There was only one RCT study with enough samples, but it was designed~     for open anterior resection, and the patients underwent diverting stoma were excluded, so~     there was the selection bias. LAR now is thought to been with the same effect, and it is safe~     and feasible. So a RCT investigation for the use of TDT for prevention of anastomotic leakage~     after LAR for medium & low rectal cancer is needed.~   "
67261|NCT02686554|"~     At the time of biomarker-substantiated diagnosis for a given AD patient it remains unclear to~     what extent the disease will devastate cognitive abilities within the next years. This is not~     only unsatisfying for the patient and the attending physician but also a major problem in the~     context of clinical trials that aim to establish new therapeutic agents. In clinical trials~     it is critically important to foresee as precisely as possible the course of the disease. The~     overall aim of the subproject is to identify a panel of CSF biomarkers to further improve~     specificity of diagnosis (disease markers), to measure disease activity and to predict AD~     progression (stage and progression markers).~   "
67262|NCT02686541|"~     The aim of this study is to study the effects of athrectomy followed by percutaneous~     transluminal angioplasty using Paclitaxel coated Drug Eluting Balloon (DEB) in treating de~     novo or re-stenotic lesions in the femoral-popliteal artery in patients with symptomatic~     peripheral vascular disease in an Asian population. The intention is to study the effects of~     debulking athrectomy followed by application of DEBs to prevent restenosis, resulting in~     improved patency rates The study will prospectively recruit 8 cases treated with athrectomy~     followed by DEB. This project is a pilot to investigate the effects of athrectomy and DEB in~     reducing re-stenosis rates. It will be a primer for a larger scale randomized controlled~     trial (RCT) involving multiple institutions to demonstrate the benefit of athrectomy and DEB~     technology to treat de novo versus plain balloon angioplasty with bail-out stenting, which is~     currently the most commonly used modality to treat femoral-popliteal lesions. There are no~     studies combining the effect of rotational athrectomy and DEBs.~   "
69149|NCT02661841|"~     We aim to determine the effectiveness of lung impedance guided preemptive therapy (LI-Guided)~     of chronic heart failure patients with preserved ejection fraction (LVEF ≥ 45%) who are being~     treated in our hospital's outpatient clinic.~   "
67263|NCT02686528|"~     The purpose of this study is to determine if hip precautions, which are instructions that~     limit functional use of a hip replacement after surgery, affect the rate of dislocation in~     the first six weeks after primary total hip replacement surgery. The impact of hip~     precautions on a patient's return to activities of daily living and overall patient~     satisfaction will also be investigated. The overall cost effectiveness of hip precautions~     will be determined.~   "
67264|NCT02686515|"~     The objective of this study is to investigate the effect of dual-task training at impairment,~     disability, and participation levels for stroke survivors and investigate possible factors~     affecting cognitive-motor interference (CMI) under dual-task conditions. Specifically, we~     will compare the immediate and retention effects of dual-task balance training and~     single-task balance training on CMI, balance confidence, fall rate, functional performance,~     and quality of life in individuals with stroke (Aim 1). The second aim of this study is to~     explore how lateralization, stroke chronicity, task type, and task difficulty may influence~     patterns of CMI (Aim 2). The third aim of this study is to investigate whether dual-task~     balance assessments are more sensitive than single-balance assessment in distinguishing~     stroke fallers from stroke non-fallers (Aim 3).~   "
67265|NCT02686502|"~     This study evaluates the effect and usability of mobile and cloud technology -based~     intervention on lifestyle modification in 18-40 year obese and overweight subjects.~      The study has a dose-response design with three randomized subjects groups from Mode 1 to~     Mode 3 with increasing intensity of intervention (guidance, exercise program, diet, support).~     The special focus of this study is on motivation and use of music and mobile health devices~     as motivational tools to support individualized exercise training, healthy diet and overall~     healthy life style.~   "
67266|NCT02686489|"~     The goal of the study is to compare the safety and efficacy of molecular water and bland~     aerosol therapy (particulate water) in providing adequate humidity to the inspired gas of~     spontaneously breathing tracheostomy patients.~   "
67267|NCT02686476|"~     Fatty liver disease is an increasingly recognized health problem in patients with type 2~     diabetes mellitus (T2DM). Sodium glucose co-transporter type 2 (SGLT-2) inhibitors are a new~     class of anti-diabetic agents that cause weight loss by inducing glycosuria. The effect of~     SGLT-2 inhibitors on liver fat content is not evaluated. Empagliflozin is an orally active,~     selective inhibitor of SGLT-2. We hypothesized that Empagliflozin, when added to standard~     care for T2DM, would improve fatty liver disease. Therefore, the present study is planned to~     evaluate the effect of Empagliflozin on the liver fat content.~   "
67268|NCT02686463|"~     This trial is designed to compare diagnostic and therapeutic effects of laparoscopy vs.~     laparotomy on early malignant ovarian cancer, and to evaluate the efficacy and safety of~     laparoscopy in early malignant ovarian cancer.~   "
67269|NCT02686437|"~     The purpose of this study is to determine the effectiveness of standard tension of~     Thera-Band® Kinesiological Tape (TB-KT) application versus varied tension on shoulder pain,~     disability, and recovery speed during an in-office rehabilitative program. A convenience~     sample size of 38 new patients with current shoulder pain will be recruited for this study.~     The outcome measures will include the Numeric Pain Rating Scale (NPRS) and the Penn Shoulder~     Score (PENN). After completing the initial paperwork, patients will be randomized into two~     groups, control (0% tension) and intervention(increasing tension). At the beginning of each~     week the tape will be reapplied, and pain rating will be recorded. At the conclusion of 4~     weeks patients will complete the PENN.~   "
67270|NCT02686424|"~     Gastric cancer is one of the leading causes of cancer-related deaths worldwide. Despite~     advances in therapeutic intervention, the mortality from this disease remains high. As a~     result, most patients are now offered varying combinations of surgery, chemotherapy, and~     radiation therapy in order to derive benefits from a multidisciplinary approach.~     Unfortunately, therapies are often toxic or debilitating and therapeutic responses can vary.~     Thus new therapeutic strategy is required for the treatment of gastric cancer.~      In the early 1980s, the discovery of cytolytic T cells (cytolytic T lymphocytes, CTLs)~     directed against an antigen presented on tumor cells was published. They can kill many~     invasive cells by recognizing the tumor specific antigens on the major histocompatibility~     complex (MHC) molecules. It is now generally agreed that although tumors express tumor~     antigens, they usually lack immunogenicity because of their inability to activate the immune~     response. The current view is that tumor cells are antigenic, but not immunogenic. If we can~     artificially activate the immune system against the tumor, it may be possible to eradicate~     the tumor. This approach is the basis of cancer immunotherapy.~      Many tumor antigens have been defined in terms of multiple solid tumors: MART-1/Melan-A,~     gp100, carcinoembryonic antigen (CEA), HER-2, mucins (i.e., MUC-1), prostate-specific antigen~     (PSA), and prostatic acid phosphatase (PAP) are just a short list. Some immune-based~     therapies targeting these tumor antigens are in phase III trials assessing whether immunizing~     against these antigens affects overall survival. In gastric cancer, some tumor antigens such~     as MAGE-A3, NY-ESO-1, and WT-1 have been reported to be expressed in substantial proportion~     of cases. They have the potential to be the targeting molecules for immunotherapy in the~     future. In this study, we aim to explore the expression levels of the four tumor markers~     (MAGE-A3, NY-ESO-1, WT-1 and PRAME) in gastric cancers of Korean patients and to examine the~     correlations of the expression levels of the four markers to clinic-patholoical factors.~   "
67271|NCT02686411|"~     Objectives:~      Primary Objective:~      To determine the change of satisfaction with quality of care after an experience on the~     Palliative Care Unit (PCU) for both patients and caregivers, as determined by the global~     rating survey.~      Secondary Objectives:~        1. To determine the change of the quality of care as determined by patients and caregivers~          utilizing validated assessment tools and global rating survey assessing different~          aspects of care after PCU.~        2. To determine domains of care that are strongly or poorly provided by the PCU, as~          reported by patient and caregiver opinions on quality of care.~        3. To determine which demographic features (i.e. cancer diagnosis; time since diagnosis;~          reason for transfer to the PCU; gender; caregiver ethnic group; comfort with the idea of~          transfer to the PCU; Memorial Delirium Assessment Scale (MDAS), Edmonton Symptom~          Assessment Scale (ESAS) and distress thermometer) may correlate with patient and~          caregiver relative satisfaction with PCU care measured by global survey and with the~          Family Satisfaction with End-of-Life Care.~   "
67272|NCT02686398|"~     During the 2013-2014 influenza season, CKD patients undergoing HD participated in the study.~     The patients were randomized into two groups (MF59-adjuvanted vaccine group or non-adjuvanted~     vaccine group) and were immunized with the respective vaccine. Sera were collected prior to~     vaccination and at 1and 6 months post vaccination. Levels of hemagglutination inhibition (HI)~     antibodies were measured.~   "
67338|NCT02685540|"~     Death rate in anesthesia is one of the most valuable methods to assess the safety of~     anesthesia practice among different types of patients.~      In the investigators study, the investigator will review the death rate in anesthesia whether~     regional or general over the past five years from 2010 to 2014, by examining the patients~     records from the hospital database.~   "
67273|NCT02686385|"~     Intervention - Subjects will be randomized to 2 groups~      Group A - subjects will receive Prednisolone for 20 days with NAC (N-Acetylcysteine)~      Group B - will receive NAC (N-Acetylcysteine) only NAC (N-acetylcysteine) dosing~      Loading dose: 150 mg/kg IV; mix in 200 mL of 5% dextrose in water (D5W) and infuse over 1~     hour~      Dose 2: 50 mg/kg IV in 500 mL D5W over 4 h~      Dose 3: 100 mg/kg IV in 1000 mL D5W over 16 h~        -  Monitoring and assessment-Liver Biopsy at baseline and at 3 months, Liver Function Test~          at regular intervals.~        -  Stopping rule-Development of sepsis, worsening of Liver functions.~   "
67274|NCT02686372|"~     Hepatocellular Carcinoma (HCC) recurrence rate is high among liver transplant patients, while~     treatment measures are limited. This study plans to recruit 10 subjects with Hepatitis B~     virus (HBV) related HCC after liver transplantation. The objective of the study is to assess~     the safety, tolerability and effectiveness of the HBV specific T cell receptor (HBV/TCR)~     redirected T cell in the target population.~   "
67275|NCT02686359|"~     If epidemiological studies indicate relatively low prevalence reported in the general~     population, idiopathic burning mouth syndrome (BMS) is a common condition among certain~     groups of the population: 30% of menopausal women experience oral burning to varying degrees~     . Despite significant progress made in recent years, in understanding the physiopathogeny,~     treatment options remain limited and disappointing,resulting in an impairment of the quality~     of life. Given the chronic nature of idiopathic burning mouth syndrome, the need to identify~     the causes and effective treatment modalities for subjects suffering is essential.~   "
67276|NCT02686346|"~     This study is designed as a phase Ib/II trial. The first part (phase Ib) is a dose escalation~     design to explore the safety and assess the recommended phase 2 dose of Brentuximab Vedotin~     in Hodgkin lymphoma patients treated with ICE regimen.~      The second part, depending on the selected dose after the completion of phase Ib part of the~     study, will further explore safety in addition to efficacy of the recommended dose of~     Brentuximab Vedotin in a selected population of patients treated with ICE with Hodgkin~     lymphoma.~   "
67277|NCT02686333|"~     This study examines the use of brief meditation interventions for patients with symptoms of~     anxiety and depression who are undergoing dialysis. Half of the participants will receive~     meditation interventions 3 times a week, while the other half will receive treatment as~     usual. This study will examine whether meditation is feasible and whether it has any effect~     on reducing symptoms of anxiety or depression.~   "
67278|NCT02686320|"~     Rheumatoid arthritis (RA) is associated with a higher prevalence of infections, malignancies,~     osteoporotic fractures and cardiovascular diseases. Few data are available regarding the~     prevalence and severity of these comorbidities in elderly RA patients. The purpose of this~     study is to determine the effect of age on prevalence and severity of comorbidities in RA.~   "
67279|NCT02686307|"~     During tachyarrhythmias, central venous pressures increases while arterial blood pressure~     (BP) decreases. The result is mixed messages to the central nervous system. On one hand, the~     unloading of the arterial baroreceptors results in reflex tachycardia and an increase in~     sympathetic nerve activity (SNA). On the other hand, the increase in filling pressure and~     thus the activation of the cardiopulmonary baroreceptors result in reflex bradycardia and~     sympathoinhibition. The investigators have previously shown that during supraventricular and~     ventricular tachycardia, arterial baroreflex gain (BRG) predominates with minimal~     contribution from the cardiopulmonary BRG. In addition, the investigators found that arterial~     BRG directly correlates with BP recovery following tachycardia termination. The roles of the~     arterial and cardiopulmonary BRGs during ventricular fibrillation (VF) however, remain~     unknown. Furthermore, the role of the arterial BRG in determining 1) BP recovery following VF~     induction and 2) the frequency of ventricular tachycardia (VT)/VF events in patients~     undergoing implantation of an implantable cardioverter/defibrillator (ICD) remain unknown.~     Analysis of the changes in sinus node cycle length during VF inductions in patients~     undergoing the implantation of a dual chamber or triple chamber ICD, provide a unique~     opportunity at looking at the autonomic changes that accompany VF.~   "
67280|NCT02686294|"~     The purpose of this study is to assess the pharmacokinetic characteristics of bepotastine~     after multiple oral administration of TALION tab., a IR formulation of bepotastine as~     reference drug and HL151, a SR formulation of bepotastine as test drug in healthy male~     adults. Additionally the safety and tolerability of two drugs will be evaluated.~   "
67281|NCT02686281|"~     The purpose of this study is to determine the toxicity, tolerability and safety of single~     ascending doses of GMC-252-L-Lysine Salt in healthy male subjects.~   "
67282|NCT02686268|"~     This research study is being performed to better understand a specific form of Amyotrophic~     Lateral Sclerosis (ALS) caused by a mutation (or abnormality) of the C9ORF72 gene. This~     mutation is the most common genetic cause of ALS, and is present in 40% of ALS patients with~     a family history of ALS and 5-10% of ALS patients without a family history of ALS.~   "
67283|NCT02686255|"~     Many toddlers and children are released home with relatively low hemoglobin levels following~     cardiac surgery, and with no careful follow up, at an age at which anemia is common. At this~     age, breast milk and its substitute do not provide enough iron, and parents are not adherent~     enough to iron supplements. Due to these facts, there is high importance, especially in~     children suffering from heart defects, for close follow up on their hemoglobin levels.~     Studies following hemoglobin trend post cardiac surgery were never done with children.~   "
67284|NCT02686242|"~     Placenta previa percreta is a dangerous complication during surgery. Due to the high risk of~     hemorrhage, most parturients with placenta previa have to accept cesarean section. In this~     study investigators compare the effect of different anesthetic techniques on these patients.~   "
67285|NCT02686229|"~     The LoG-Glio-Registry is based on a network of german hospitals gathering radiological,~     clinical, epidemiological and molecular data on all patients diagnosed with a low grade~     glioma.~   "
67286|NCT02686216|"~     Biodistribution, pharmacokinetics, and safety of F-18 THK-5351 PET in Alzheimer's disease~     patients and healthy subjects.~   "
67287|NCT02686203|"~     evaluating The Investigational Therapy effects on quality of life, pain and patient's~     clinical status in adult cancer patients with solid tumors who are no longer candidates for~     active oncological therapies.~   "
69150|NCT02661828|"~     The purpose of this study is to compare two ways to stop taking an antidepressant medication~     and determine whether a faster or slower taper is better tolerated.~   "
67288|NCT02686190|"~     Background: Management of patients with Alzheimer's disease associated with behavioral~     disturbances is difficult especially in those with agitation/aggression and insomnia and~     nighttime behaviors. No treatment has shown any efficacy to control these disturbances and~     psychotropics drugs, i.e. sedatives and hypnotics have numerous adverse effects.~      Objective: Assess the effect of bright light therapy on behavioral disturbances of patients~     with Alzheimer's disease, especially the effect on agitation/aggression and insomnia and~     nighttime behaviours.~      Study design: Multicenter non pharmacological intervention trial, controlled, randomized,~     open, two-arm design : control group and intervention group.~      Centres : Rehabilitation and long term-care units of 4 geriatric hospital wards.~      Patients: 120 patients admitted in geriatric hospital wards (30 by centre), with probable~     Alzheimer's disease according to DSM-IV diagnosis criteria and agitation/aggression~     (associated or not with insomnia or nighttime behaviors) according to the Neuropsychiatric~     inventory, nurse scale (NPI-nurse).~      Treatments: Intervention group: patients will participate in a program of bright light~     therapy realised during a one-hour sessions of occupational therapy,. These sessions will be~     realised for groups of 6 patients and will be done every week day, at late morning, for 4~     consecutive weeks). During the session, patients will be exposed to 10000 lux-bright light.~     Patients of control group will participate in a program of occupational therapy of same~     duration and rhythm, realised in standard light conditions (about 300 lux).~      Assessment: Patients with be assessed on 3 occasions: inclusion, two and four weeks after the~     beginning of the programs. Assessment will comprise ; NPI-nurse scale and Cohen-Mansfield~     scale for behaviour disturbances, wrist actimetry for sleep and nighttime behaviours (total~     sleep length, nocturnal wake episodes and nocturnal motor agitation).~      Judgment criteria: Principal: changes in the agitation/aggression item of NPI-nurse scale.~     Secondary: changes of the nightime behaviours item of NPI-nurse scale, the Cohen-Mansfield,~     total sleep duration and numbers of nocturnal wake episodes measured by wrist actimetry.~      Statistics: Changes in agitation/aggression scores od the two groups will be compared by Mann~     and Whitney test.~      Expected results and perspectives; If bright light exposure is efficient, professional~     caregivers of Alzheimer's disease patients might apply this cheap and non pharmacological~     approach to improve behaviour and sleep of these patients. This study might contribute to~     better define the place of a non invasive and promising technique, wrist actigraphy, to~     assess sleep and behaviour disturbances in psychogeriatric patients~   "
67289|NCT02686177|"~     GLP-1 receptor agonists are introduced in the treatment of type 2 Diabetes (T2D) and their~     efficacy is documented. However, safety aspects are also important to evaluate with respect~     to micro and macrovascular complications associated with T2D. Few studies have properly~     addressed the role of GLP-1-based therapies in regulating vascular integrity and~     angiogenesis. The study evaluate the impact of one-month treatment Liraglutide on both ANGPT2~     and ANGLPT4 levels and endothelial circulating progenitor cells, angiogenesis biomarkers in~     type 2 diabetic patients.~   "
67290|NCT02686164|"~     This is a multicenter, open-label, non-randomized Phase 1 study in participants with advanced~     solid tumors, excluding hepatocellular carcinoma (HCC), that have progressed after treatment~     with approved therapies, or for which there are no standard therapies available. The study~     will also include participants with radioiodine-refractory differentiated thyroid cancer~     (RR-DTC). Its primary intent is to determine the effect of lenvatinib on CYP3A4 activity as~     well as to assess the safety and activity of lenvatinib in these participants. The study will~     be conducted in the following 3 phases: Pretreatment Phase, Treatment Phase, and Extension~     Phase.~   "
67291|NCT02686151|"~     To investigate the effect of letrozole in patients who have high risk of ovarian~     hyperstimulation syndrome (OHSS) after oocyte retrieval, the incidence of OHSS were~     calculated between letrozole group and supporting treatment group.~   "
67292|NCT02686138|"~     This phase 3, 26-week, randomized, double-blind, placebo-controlled, multi-center study will~     evaluate the safety and efficacy of one dose of Tenapanor in subjects with~     constipation-predominant irritable bowel syndrome (IBS-C) as defined by the ROME III criteria~     and who have active disease as determined after a two-week screening period. Subjects who~     qualify and are randomized into the study will either receive 50mg BID of Tenapanor (1:1) for~     a 26 week treatment period.~   "
67293|NCT02686125|"~     To compile characteristics of real-world outcomes of Boston Scientific Corporation's~     commercially approved VerciseTM Deep Brain Stimulation (DBS) Systems for the treatment of~     dystonia.~   "
67294|NCT02686112|"~     The study aims to quantify the relations between first & second trimester bleeding and~     maternal & neonatal morbidity. Additionally, the study will help in assessing the risk for~     abortions in women with threatened abortions and the risk factors for threatened abortion.~   "
67295|NCT02686099|"~     The SternaLock 360 Sternal Closure Device combines the techniques of rigid fixation with a~     cerclage material into a single sternal closure system. The cerclage material serves to~     facilitate sternal approximation, and the plates and screws serve to provide rigid fixation~     and prevent sternal movement and separation. The combination of a cerclage material in~     combination with plate and screw fixation may also lead to increased stability compared to~     either method used as a standalone means of closure.~   "
67296|NCT02686086|"~     Treatment of chronic obstructive pulmonary disease (COPD) incorporates various modes of~     inhalation therapy. The response to treatments is dose dependent thus applying the most~     efficient device to administer the treatment is integral. Evaluation of the efficacy of~     nebulisation devices in the treatment of COPD is limited. Technological development in recent~     years has led to new devices that optimize lung deposition and reduce the time needed for~     treatment.~      The aim of this study is to compare the vibrating mesh and jet nebuliser methods of~     delivering bronchodilator medication to patients hospitalised with an acute exacerbation of~     COPD, with respect to lung function and efficacy in spontaneously breathing patients.~   "
67297|NCT02686073|"~     Study the rate of progress of labor among nulliparous women belonging to different body mass~     index groups, & observe how does this variation in maternal body mass index may affect the~     course of labor.~   "
67298|NCT02686060|"~     While venous access is an essential part of caring for the preterm neonate potential severe~     adverse events, including contamination of fluids with bacteria, endotoxins and particulates~     could occur (Bethune 2001).~      Infusion therapy carries a risk for catheter-associated septicaemia (Geiss 1992) originated~     from the catheter tubing, the ports, at the cannula site or from contaminated infusion fluid.~     While not all infections lead to septicaemia, immuno-compromised patients such as neonates~     are at greater risk, and infection becomes a major problem (Ng 1989) and a major risk factor~     for neurodevelopmental disabilities (Volpe 2008). Indeed, it has been postulated that~     endotoxins may be involved in the pathogenesis of a proportion of cases of periventricular~     leukomalacia, the most frequent brain damage associated with neurocognitive handicaps in the~     human neonate (Volpe 2001).~      The presence of calcium in parenteral nutrition mixture leads to precipitation due to its~     incompatibility with the other components of the admixtures and leads to high concentration~     of particles (Athanasiou 2014). Adverse systemic effects of particulate matter including~     phlebitis, granulomata formation in the lung (Marshall 1987) and ischaemic necrosis, are a~     common finding in necrotizing enterocolitis another serious complication flowing preterm~     birth (Ballance 1990). Particle contamination of infusion solutions exists despite a~     stringent infusion regiment. The number and composition of particles depends on the~     complexity of the applied admixtures (Jack 2010).~      Particulate contamination is due to drug incompatibility reactions or their incomplete~     reconstitution during the preparation process (Schroder 1994). Various studies have~     demonstrated the contamination of infusion solutions with glass particles from opening glass~     ampoules, particles from rubber stoppers or conglomerates of the parenteral nutrition~     components (Ball 2003). Particles have also been shown to be inherent to generic drug~     formulation (Oie 2005). In an intensive care setting the particle burden may rise up to one~     million infused particles per day, increasing with the complexity and quantity of the~     administered infusions (Walpot 1989).~      There are two main IV filter pore sizes; the 0.2 micron filter is used for aqueous solutions,~     and the 1.2 micron filter is recommended for larger molecule solutions such as lipids. The~     0.2 micron filter has also been reported to remove air, microorganisms and particulate~     matter. In addition, endotoxin retention is reportedly achieved by using a positively charged~     filter membrane; toxic macro-molecules are released by gram-negative bacteria and are claimed~     to be effective for up to ninety six hours (Bethune 2001).~      In-line IV filters are currently claimed to be an effective strategy for the removal of~     bacteria, endotoxins and particulates associated with intravenous therapy in adults (Ball~     2003) and particularly effective in the removal of particles caused from drug precipitate~     such as antibiotics (Chee 2002; Ball 2003).~      However, evidence of the beneficial effect of in-line IV filters in children and neonates is~     much weaker, despite some positive studies (Jack 2012; Boehne 2013; Sasse 2015). In the~     population of preterm infants, no study is currently available while particulate~     contamination due to infusion therapy carries a higher health risk in this subpopulation.~      The benefits of using IV in-line filters in critically-ill preterm neonates remains to be~     demonstrated. This intervention in adults has also been challenged by several authors~     (Pearson 1996; Newell 1998). Friedland reported that certain drugs such as antibiotics may be~     retained in the filters causing a reduction in potency (Friedland 1985). On the other hand,~     there are no known adverse effects from the use of IV in-line filters.~   "
67299|NCT02686047|"~     Viscosupplementation has been widely used for the treatment of knee osteoarthritis (OA).~     There is no well controlled trial comparing one injection regimen of HA for the treatment of~     knee OA. The purpose of this study was to compare the efficacy and safety of one~     intraarticular injection of a novel crosslinked HA (HYAJOINT Plus) with Synvisc-One for the~     treatment of knee OA.~   "
67300|NCT02686034|"~     This study is a prospective, multi-centre, randomised, double-blind, sham-controlled~     investigation designed for comparison of two parallel treatment groups: gammaCore (active~     nVNS treatment) and a Sham device (control treatment), for the acute treatment of migraine~     attacks~   "
67301|NCT02686021|"~     Postoperative pain is common and particularly outpatients may experience unsatisfactory pain~     relief. This randomized, double-blind, crossover study of postoperative pain in outpatients~     undergoing split-mouth, third lower molar extraction aims to examine whether or not the~     combination of metamizole and ibuprofen is superior to either drug alone.~   "
67302|NCT02686008|"~     This is an open label pilot study evaluating the pharmacodynamics and safety of single agent~     olaparib administered at 300mg bid (twice a day) for 14 days orally in patients with human~     papillomavirus (HPV) -positive and human papillomavirus (HPV)-negative head and neck squamous~     cell carcinoma (HNSCC)~   "
67304|NCT02685982|"~     Major depressive disorder (MDD) is a highly prevalent and disabling disorder associated with~     persistent low mood, loss of the capacity to experience pleasure (i.e. anhedonia), reduced~     social functioning, and impaired quality of life. MDD is estimated to affect approximately 2%~     of Canadian women and 1% of Canadian men at any point in time. The World Health Organization~     affirms that depression is the leading cause of disability worldwide, with increasing global~     economic impact.~      Standard treatments for depression include basic psychosocial support combined with~     antidepressant medication or psychotherapy. It has been observed, however, that only 50% of~     individuals respond to psychological treatment, and only 30-40% of patients achieve full~     remission after initial treatment with antidepressants. Music- and sound-related therapies~     have the potential to serve as adjuncts to, or facilitators of, medication.~      In this study we will examine the effectiveness of a new therapeutic tool, known as Rhythmic~     Sensory Stimulation, as an adjunctive treatment for Major Depressive Disorder. Rhythmic~     Sensory Stimulation is a non-invasive brain stimulation technique that uses periodic pulses~     of light, sound, or tactile stimulus, to induce changes in the patterns of brain activity.~     Participants in this study will undertake 30 minutes of daily music intervention~     self-administered at home, for 5 days per week, for a total of 5 weeks. We will assess~     depression symptoms, sleep quality, quality of life, and brain activity pre- and~     post-treatment.~      The results of the present study will help to better understand the effectiveness of Rhythmic~     Sensory Stimulation to the treatment of mood disorders, and contribute to the development of~     future studies to investigate the neural driving effects of therapies based on Rhythmic~     Sensory Stimulation.~   "
67305|NCT02685969|"~     Study to understand factors related with the preclinical stages of Alzheimer's Disease and~     investigate markers that predict its progression.~      Cross-sectional and single arm study performed on a subgroup of individuals recruited in the~     ALFA project.~      Study without therapeutic interest for the research participants (440 participants of the~     ALFA project who have been selected for being cognitively healthy and in their vast majority~     are direct descendants of patients diagnosed with Alzheimer's Disease).~      Each study candidate will be selected from the ALFA project (STUDY 45-65 FPM/2012) according~     to their clinical characteristics, their compliance to selection criteria and their desire to~     participate in this study.~      After signing this study's specific informed consent form, the neuropsychological screening~     and the brain MRI acquisition will be performed. Once all inclusion criteria are checked, the~     PET scans with 18F-Flutemetamol and 18F-FDG will be performed~   "
67306|NCT02685956|"~     The purpose of this study is to evaluate the performance of the Sentosa SA HSV1/2 Qualitative~     PCR Test. Precision of results and concordance of results with a reference assay will be~     evaluated.~   "
67307|NCT02685943|"~     Although suicide risk is highly prevalent among the patient population in mental health care,~     remarkably little research exists on effective treatments. Among a small set of novel~     approaches, CAMS is particularly promising. The investigators compare CAMS to TAU in a~     randomized controlled trial at four departments in Vestre Viken Hospital Trust, hypothesizing~     CAMS to be the superior approach. Primary outcome measures are suicidal ideation and suicide~     attempts, with secondary outcome measures including general symptoms of mental health~     problems. Changes in the outcome measures are compared between the two groups from baseline~     to 6 and 12 months after patients are included in the study. The study has the potential to~     impact the science of treating suicidal individuals and it could benefit the general public~     by establishing CAMS as an effective clinical approach for rapidly reducing suicide risk.~   "
67308|NCT02685930|"~     The purpose of this observational study is to collect prospective data on the occurrence of~     bacterial and viral pneumonia in the ICU setting. Current classification systems for~     pneumonia promote over treatment with antibiotics as they do not specifically recognize the~     presence of culture-negative and viral pneumonia. The investigators will collect data to~     determine if a novel pneumonia classification system can be developed that more accurately~     links the etiology of pneumonia (antibiotic-susceptible bacterial pneumonia,~     antibiotic-resistant bacterial pneumonia, culture-negative pneumonia, viral pneumonia) to~     clinical outcomes. Additionally, the investigators will collect data on the practice of~     antimicrobial stewardship in the ICU setting to determine if further improvements in~     antibiotic practices can be accomplished in the future.~   "
67309|NCT02685917|"~     The quality of cartilage regeneration after marrow stimulation is well documented to be~     unpredictable, because they do not regenerate consistent amount of cartilage. To overcome the~     shortcomings of the microfracture technique, various augmentation techniques using synthetic~     collagen matrix, scaffolds or plug devices have been developed. However, their efficacy~     remains unclear. The purpose of this prospective randomized controlled study is to evaluate~     whether the microfracture in combination with collagen gel augmentation could improve the~     quality of cartilage regeneration in patients undergoing medial open wedge high tibial~     osteotomy (HTO) for the treatment of medial unicompartmental knee osteoarthritis (OA).~   "
67310|NCT02685904|"~     This is a multi-center, double-blind, randomized, parallel-group, placebo-controlled study to~     evaluate the efficacy and safety of ENIA11 in patients with ankylosing spondylitis. The study~     period for each patient will be 27 weeks, during which the patient will undergo screening for~     up to 21 days, and followed by treatment of 24 weeks and follow up period of 2 weeks. Each~     patient will be required to make a total of 9 visits.~      After re-confirming the eligibility of patients at Visit 2, eligible patients will be~     randomly assigned to either treatment group or control group in a 2:1 ratio. In addition,~     patients in the treatment group will receive ENIA11 25 mg twice weekly by subcutaneous~     injection while patients in the control group will receive placebo solution twice weekly by~     subcutaneous injection from Day 0 to week 12 and then switch to active drug from week 12 to~     week 24 and follow up period of 2 weeks.~      The efficacy analysis, including ASAS response measures, ASAS5/6, ASDAS, BASDAS, BASFI, BASMI~     and individual measures of disease activity, such as numbers of swollen and tender joints,~     ESR and CRP, will be evaluated at each visit from Visit 2 (baseline) to Visit 9. Safety will~     be evaluated according to the frequency of adverse events, vital signs, physical examination,~     laboratory abnormalities, and ENIA11 antibody formation.~   "
67378|NCT02685020|"~     The primary purpose of this study is to assess safety, tolerability of the different vaccine~     schedules (different regimen durations and different number of dose administrations) with~     Ad26.Mos.HIV and Clade C Glycoprotein (gp) 140 and to assess Envelope (Env)-binding Antibody~     (Ab) responses of the different vaccine schedules.~   "
67311|NCT02685891|"~     In this study, the investigator evaluates whether there are age-specific diurnal changes in~     markers of cortical plasticity in children, adolescents and adults. The question will be~     investigated by the quantification of brain metabolites and structural brain volumes using~     magnet resonance imaging (MRI) and electrophysiological markers using sleep encephalography~     (sleep EEG). In a second step, it will be tested how these markers of cortical plasticity~     change depending on a modulation of sleep by applying tones during deep sleep.~   "
67312|NCT02685878|"~     The purpose of this study is to describe the long-term surgical success, quality of life,~     prevalence of depression, fertility rates, and pregnancy outcomes of patients who have~     undergone obstetric fistula repair.~      This will be a study involving up to 300 women 1-3 years after they have undergone obstetric~     fistula repair at the Fistula Care Center in Lilongwe, Malawi.~      Patients who underwent obstetric fistula repair between January 1, 2012 and July 31, 2014~     will be identified from an existing database of fistula patients. They will then be contacted~     and invited to participate in the study. Consented patients will complete a 1-hour pad weight~     to evaluate urinary continence, a demographic questionnaire, an incontinence-related quality~     of life metric, and a depression metric. The data will be analyzed and then disseminated to~     stakeholders.~   "
67313|NCT02685865|"~     The research design is a randomized prospective clinical trial comparing Endoscopic~     ultrasound (EUS) guided drainage of WON using FCSEMS and plastic stents. The trial will be~     conducted at the Florida Hospital Center for Interventional Endoscopy, Orlando, Florida.~   "
67314|NCT02685852|"~     The purpose of the study is to evaluate the effectiveness of exenatide in adults experiencing~     episodes of hyperinsulinemic hypoglycemia following Roux-en-Y bariatric surgery.~   "
67315|NCT02685839|"~     Elderly care has become one of the most important subjects in Taiwan and frailty syndrome~     are the most common problems among the elderly. In view of this trend, Taipei Veteran~     Memorial Hospital imported POWER rehabilitation from Japan in 2008. While showing significant~     clinical benefits, investigators have found that the system still has certain limitations~     (e.g. high cost, requires large space, patients must commute to the center, lacks real-time~     objective feedback , boring routines makes staying power to motivate patients for long term~     rehabilitation programs.)~      To overcome the above limitations, this project proposes an evidence-based rehabilitation~     model that accounts for actual clinical need and collaborates with our engineering team to~     develop a cluster , wearable and Brain-Computer Interface System version of POWER~     rehabilitation system. Combining cloud technology, investigators now introduce~     internet-of-things into the POWER rehabilitation procedure. The result will lower the burden~     of clinical support personnel, and provide an opportunity to quantify frailty syndromes so~     as to allow objective and quantitative scientific evaluation, leading to a more objective~     clinical diagnosis.~      In addition, this project further proposes a virtual-reality (VR) system for POWER~     rehabilitation, as well as designs for the VR sceneries. Through the use of different~     animated 3D VR sceneries and interactive game design, investigators can make rehabilitation~     interesting and fun for the patients, motivating long-term compliance of the patients,~     thereby, improving the clinical outcome of POWER rehabilitation.~      This project has the potential to create an innovative solution to address the current~     bottlenecks of our rehabilitation treatment model. Successful development of the system will~     offer rehabilitation clinicians more treatment options, lower the cost of supporting staff,~     reduce commuting cost for the patients, and elevate patient desire to comply with the~     treatment program. Finally, the system will not only enhance Taiwan's academic reputation in~     the international arena, it will also generate new commercial opportunities for Taiwan and~     contribute to Taiwan economic development.~   "
67316|NCT02685826|"~     This is a multicenter, open-label, Phase 1/2 study to determine the recommended dose and~     regimen of durvalumab in combination with lenalidomide (LEN) with and without dexamethasone~     (dex) in subjects with Newly diagnosed multiple myeloma (NDMM).~      The study will consist of a dose-finding phase as well as a parallel dose-expansion phase to~     determine the optimal regimen.~   "
67317|NCT02685813|"~     Neural tube defects cover a group of severe embryo malformations such as anencephaly and~     spina bifida. The most severe forms of spina bifida causes numerous disabilities that demand~     lifelong treatment by a team consisting of primarily neurosurgeons, pediatricians,~     obstetricians, pediatric neurologists, pediatric urologists, gastroenterologists,~     psychologists and social workers. The disabilities involve morbidity such as decreased motor~     and sensory function caudal to the lesion, hydrocephalus, scoliosis, bladder and bowel~     incontinence as well as increased mortality.~      In 2004, the Danish Health Authorities introduced new guidelines for fetal diagnostics. These~     represented a change of paradigm stating that all pregnant women should be offered a prenatal~     examination including an ultra sound scan in week 12-13 of gestation (including risk~     estimation of chromosomal diseases) as well as in week 19 of gestation (scanning primarily~     for malformations). The examination program was not elaborated to eradicate diseases but to~     support the reproductive autonomy of the pregnant women, including the possibility to seek~     for termination of the pregnancy in the case of severe disease in the fetus.~      Severe spina bifida is one of the malformations that can be diagnosed with the ultra sound~     scan in week 19, and since the implementation of the new guidelines from the Danish Health~     Authority a study by this research group has shown decreased birth incidence at least in the~     Western part of Denmark.~      It is still unknown what has caused this decrease as is the exact number of pregnancies and~     births complicated by spina bifida in the child; similarly it is unclear whether this decline~     is a regional or if it is only a Danish phenomenon.~      By extraction of data from the Danish Fetal Database (FØTOdatabasen) which includes~     information of all 60.000 pregnancies in Denmark annually, the purpose of this register study~     is to investigate the incidence of pregnancies complicated by prenatal diagnosis of spina~     bifida in Denmark from 2008 and on, as well as the pregnancy outcome in these cases~     (including termination of pregnancy). Furthermore results will be compared to results~     obtained by collaborative partners in Sweden and hopefully also in Saudi Arabia.~   "
67318|NCT02685800|"~     Assisted Reproductive Technologies (ARTs) are widely used in couples with fertility problems.~     However, despite ART treatment options have evolved over time, the implantation rate remains~     rather low.~      A possible role for inherited and acquired thrombophilias has been invoked, especially in~     women with previous implantation failures. However, several factors could play a role in~     these conditions.~      A potential benefit of low-molecular-weight heparin (LMWH) in improving ART outcomes,~     independently of the presence of thrombophilia, has been recently suggested.~      This register is designed in order to better define all possible variables influencing ART~     outcome and improve clinical management of women with previous implantation failures. During~     this study the investigators will collect and evaluate clinical data regarding the first~     cycle in women with previous ART failures.~   "
67319|NCT02685787|"~     This randomized trial evaluates the efficacy of counselling for reducing anxiety and~     depression in caregivers of patients with dementia. Half of the participants will receive six~     hours providing counselling and psycho-social support to caregivers along with a specific~     telephone support service - Ad Hoc Telephone Counselling whereas the remaining participants~     will receive six hours providing general information about Alzheimer Disease.~   "
67320|NCT02685774|"~     This study is a randomized, open-label, single dose, 2-way crossover study to compare the~     pharmacokinetic characteristics of CKD-395 0.25/500 mg in healthy male volunteers.~   "
67379|NCT02685007|"~     The purpose of this study is to describe ease of use and satisfaction with application of the~     pre-rolled TachoSil in laparoscopic procedures within approved therapeutic indication as per~     Summary of Product Characteristics (SmPC).~   "
67321|NCT02685761|"~     It is the purpose of this study to evaluate the relationship between a low transverse,~     vertical midline, and supra-panicular high transverse skin incisions and the rate of wound~     complications in women with a BMI of 40 or greater undergoing a cesarean section for~     delivery. So far, the choice of incision for the morbidly obese is based only on case~     reports. No randomized controlled trials have been done up to date comparing these methods.~     It is our hope that a high transverse incision will have all of the benefits of a low~     transverse skin incision, with the added benefit of better exposure offered by a vertical~     midline incision, without the added increased risk of subjecting the woman to a vertical~     hysterotomy.~   "
67322|NCT02685748|"~     In this double blind randomized clinical trial the investigators are going to exam influence~     of adjuvant Aspirin therapy on soft neurological signs (Heidelberg scale), positive and~     negative symptoms (PANSS), cytokine profile and inflammatory factors, as well as on cognition~     (MoCA) in young psychotic patients.~   "
67323|NCT02685735|"~     The objective of this research study is to better understand patterns of recovery after Total~     Knee Arthroplasty (TKA). The study will evaluate how pain, activity and cognitive (i.e.,~     thinking style) responses determine patterns of recovery, and the study will evaluate the~     efficacy of gabapentin versus placebo for improving recovery after surgery.~   "
67324|NCT02685722|"~     This study for a six-month trials, Randomized, open, and parallel comparison before and after~     its own, Stage test includes screening stage, treatment period and follow-up period. In~     accordance with chronic wound criteria for the patient, By producing the principle of random~     number, Were randomly divided into UC-MSCs Gel group or Gel group, The researchers according~     to the situation of wound healing time and decided to use the secondary treatment, To observe~     the clinical efficacy and safety.~   "
67325|NCT02685709|"~     Octreotide capsule is a novel, orally-administered formulation of the commercially-available~     injectable drug octreotide. In a recent phase 3 trial, oral octreotide capsules demonstrated~     sustained biochemical response up to 13 months in patients with acromegaly previously managed~     with somatostatin analog injections (ref).~      The purpose of this study is to compare the efficacy safety and patient reported outcomes~     between oral octreotide capsules and injectable somatostatin analogs.~   "
67326|NCT02685696|"~     Objective:~      To investigate if the use of the newly designed Alexis O Retractor leads to improved~     intra-operative and post-operative surgical outcomes in the setting of planned elective~     Caesarean Sections.~      Study Design:~      This ethically approved study is designed as a prospective, randomized controlled trial in~     planned, first time Caesarean Sections with 200 patients randomized to either the Alexis-O~     Retractor group or the conventional group. Patients with wound healing problems, connective~     tissue disorders, insulin dependent diabetes, bleeding disorders, previous major abdominal~     surgery and chorioamnionitis are excluded. Outcomes include surgical site infection,~     intraoperative parameters such as tissue damage, postoperative analgesia requirements and~     patient satisfaction scores.~   "
67327|NCT02685683|"~     This study is designed to explore mechanism of action of mongersen (GED-0301) 160 mg once~     daily in patients with active Crohn's Disease~   "
67328|NCT02685670|"~     This is a single-arm open-label phase I/II study to determine the relative superiority of~     αCD19-TCRζ-CD28 and αCD19-TCRζ-CD137 CAR-T Cells in safety, efficacy and engraftment~     potential in patients with CD19+ B-lineage leukemia and lymphoma. Recently, cancer~     immunotherapy, treatments aiming to arm patients with immunity specifically against cancer~     cells, has emerged as a promising therapeutic strategy. Clinical trials utilizing CARs~     against B cell malignancies have demonstrated remarkable potential. In this trial, all~     subjects will be competitively infused with αCD19-TCRz-CD28 and αCD19-TCRz-CD137 CAR-T cells~     in equal number to test a hypothesis that CD137-costimulation can promote the persistence and~     engraftment of CAR-T cells and this superiority can lead to improved progression-free~     survival.~   "
67329|NCT02685657|"~     The purpose of this study is to increase survival of patients with early and locally advanced~     triple-negative breast cancer adding selumatinib to standard preoperative chemotherapy~     regimen.~   "
67330|NCT02685644|"~     Laparoscopic excision of endometriotic cysts is the main stream surgical intervention for~     treatment of endometriosis. However there is evidence that intervention may effect ovarian~     reserve by destruction of healthy ovarian tissue during surgery. Available evidence on the~     topic are contradictory and employed research methodology are diverse. There is need for an~     adequately powered research with proper methodology to assess actual effects of surgery.~   "
67331|NCT02685631|"~     This research registry studies Yttrium Y 90 resin microspheres in collecting data from~     patients with liver cancer not capable of being removed by surgery (unresectable) for the~     radiation-emitting Selective Internal Radiation-Spheres (SIR-spheres) in non-resectable~     (RESIN) liver tumor registry. The information generated will help doctors better understand~     treatment patterns involving Y90 therapy, gain additional insights in the long-term outcomes~     for patients, as well as guide future research for using Y90 therapy, especially for those~     conditions where data is currently very limited or lacking.~   "
67332|NCT02685618|"~     Objective: Safety and efficacy of low-dose prostacyclin administration and blood pressure~     target in addition to standard therapy, as compared to standard therapy alone, in~     post-cardiac-arrest-syndrome (PCAS) patients.~      Trial Rationale: Therapeutic interventions directed towards the damaged endothelium may~     improve outcome for patients with PCAS. Prostacyclin/Iloprost (PGI2) is an endogenous~     prostanoid which is formed and released by endothelial cells with anti-platelet, vasodilatory~     and cytoprotective properties36 and is expected to be beneficial by protecting and~     deactivating the endothelium and by restoring vascular integrity in patients suffering from~     endothelial breakdown.~      Trial Population: Participants in the trial must be adult patients (≥18 years of age) with~     out-of-hospital cardiac arrest (OHCA) of presumed cardiac cause admitted to the Dept. of~     Cardiology, 2143, Rigshospitalet, Copenhagen.~      Trial Design: Randomized, placebo controlled, double-blind investigator-initiated trial in 40~     OHCA patients. 48 hours of active study drug (Iloprost, 1 ng/kg/min) versus placebo (saline)~     infusion.~      Patients in both randomization groups will be treated in accordance with state-of-the art~     therapy including targeted temperature management. Interventions are considered emergency~     procedures and study drug infusion should be commenced as soon as possible after sustained~     return of spontaneous circulation (ROSC), screening and randomization.~      Patients will only be enrolled after informed consent, but as the treatment has to be~     initiated earliest possible after the out of hospital cardiac arrest diagnosis i.e., at a~     time-point where patients are temporarily incompetent, scientific guardians will co-sign the~     informed consent form before inclusion. Next-of-kin and the patients' general practitioner~     will co-sign as soon as possible and the patient will provide informed consent whenever~     possible.~      During the study, blood samples will be taken at different time points. Patients will be~     observed and assessed continuously with regards to complications including bleeding. Patients~     will be actively assessed as long as the patient is in the ICU. During the extended follow up~     period at day 30, 90 and 180 contact will be made with the patients to follow up on safety~     events and vital status.~      The trial is conducted in accordance with the protocol and is approved by Danish health and~     medicines authority, Danish ethics committee and danish data protection agency.~      Investigational product: The active treatment in the trial is 1 ng/kg/min Ilomedin®~     administered as a 48h continuous i.v infusion. The drugs will be administered according to~     the product specifications.~      Placebo: The placebo is 0.9% saline administered as a 48h continuous i.v infusion. The i.v~     volume of placebo saline to be administered is equal to the administered volume of diluted~     (in 0.9% saline) active drug.~      Sponsor of study and financial support: This research project is investigator-initiated by~     the trial Sponsor Pär I. Johansson in collaboration with the principal investigator Christian~     Hassager.~      It has not received funding from any commercial sponsors.~      Patient recruitment period runs from February 2016 to August 2016. Follow-up data on 30-day,~     90-day and 180-day outcome and adverse events will be collected. Initial data analyses will~     be done after completion of 30-day follow-up for all patients. Secondary data analyses will~     be done after completion of 180-day follow-up for all patients.~   "
67333|NCT02685605|"~     INTRAGO II resembles a multicentric, prospective, randomized, 2-arm, open-label clinical~     phase III trial which tests if the median progression-free survival (PFS) of patients with~     newly diagnosed glioblastoma multiforme (GBM) can be improved by the addition of~     intraoperative radiotherapy (IORT) to standard radiochemotherapy.~   "
67334|NCT02685592|"~     This study investigates the efficacy of photodynamic therapy (PDT) in the treatment of~     lentigo maligna (LM). Hyperspectral imaging system (HIS) will be used to determine the~     margins of LM and to rule out possible invasion. Participants will receive photodynamic~     therapy three times consecutively with intervals of two weeks using 5-aminolevulinic acid~     nanoemulsion (BF-200 ALA, Ameluz®) as a light sensitizing cream. Four weeks after last~     photodynamic therapy the lentigo maligna lesion will be excised surgically from the skin.~     Result of the treatment is assessed with histopathological examination and~     immunohistochemical staining of removed tissue specimen.~   "
67335|NCT02685579|"~     Obstructive Sleep Apnea may cause dizziness or vertigo through hypoxia of the vestibular~     nuclei in the brain. Treating sleep apnea may improve dizziness or vertigo.~   "
67336|NCT02685566|"~     The purpose of this pilot is to assess the adequacy of the Fujifilm DBT Reader Study Training~     program to ensure that Readers participating in the Fujifilm DBT pivotal trial are properly~     trained in the reading and interpretation of FFDM and DBT images.~   "
67339|NCT02685527|"~     Isolation of contagious patients is expensive, requires more caregiver time, most of the~     patients perceive isolation as a mental strain and it has been shown that the level of care~     and observation is lower than in a normal ward. But isolation of contagious patients is~     necessary to protect other patients, hospital staff and relatives to prevent spreading of~     infection and, in worst case out-break.~      There are different isolation regimes available depending on causative agent and mode of~     transmission. A community-acquired acute gastroenteritis (GE) is most often caused by~     Norovirus while a hospital-acquired acute GE is often caused by toxin producing Clostridium~     difficile. Patients infected with Norovirus or Clostridium difficile have to be isolated in~     single rooms with strict contact precautions. Patients infected with acute GE caused by other~     pathogens can be isolated in a multi-bed room if there is a private toilet.~      However, at the time of arrival to hospital it is not known if the patient is contagious. The~     indication of isolation has to be made based of a clinical evaluation in risk of isolating to~     few or too many patients.~      Aim of the study:~      To identify anamnestic, clinical and paraclinical variables that can be used as indicators of~     the aetiology of infectious GE, thus giving an indication for isolation.~      To clinically evaluate a combined RNA (Norovirus) and DNA (Clostridium difficile) fast PCR~     analysis test to identify infectious GE compared to gold standard methods.~   "
67340|NCT02685514|"~     To evaluate the short-term efficiency and safety of HIFU treatment in the relapsed Graves'~     disease.~   "
67341|NCT02685501|"~     As combat women soldiers are required to more intensive daily activity the investigators~     believe that the impact of menorrhagia, dysmenorrhea and its clinical consequence (as~     characterized by, anemia iron deficiency and reduced quality of life)) on personal~     performance will be more significant in combat women soldiers compared to non-combat women~     soldiers. Using cohorts from the same environment will enable the investigators to better~     study the effect of menorrhagia and dysmenorrhea eliminating other uncontrolled factors, such~     as nutrition. The study does not include any intervention.~   "
67342|NCT02685488|"~     Depression is the leading cause of disability worldwide. Because a significant number of~     people with depression do not respond to medication or therapy, alternative treatment options~     are greatly needed. Recent research has focused on brain stimulation methods due to their~     therapeutic utility for treating depression. Yet, current brain stimulation methods have~     drawbacks, including invasive surgery and limited precision in targeting specific areas. A~     novel brain stimulation method, transcranial ultrasound (TUS), is noninvasive, has greater~     spatial precision than most existing methods, and is proven safe for humans. TUS has been~     found to increase positive mood in chronic pain patients. In a double blind study, TUS~     increased positive mood in over 140 healthy undergraduates at the University of Arizona.~      Despite evidence that TUS can increase positive mood in humans, it has yet to be investigated~     whether TUS can increase positive mood in humans who are experiencing chronic low mood or~     depression. The present study will, for the first time, examine whether TUS can improve~     depressive symptoms. Twenty to thirty participants with mild to moderate depressive symptoms~     (Beck Depression Inventory Score between 10 and 25) will be randomly assigned to a TUS sham~     or TUS activation condition. In the TUS activation condition, TUS will be used to stimulate~     the right fronto-temporal area, which has previously been shown to increase positive mood.~     Participants in the TUS sham condition will not receive any brain stimulation. Participants~     will attend five sessions within seven days or ten sessions within fourteen days. At each~     session, in addition to brain stimulation, self-reported mood and depressive symptoms will be~     recorded. Furthermore, the investigators will use electroencephalogram (EEG) to record~     changes in brain electrical signals during TUS stimulation. Based on prior research, the~     investigators predict that mood will increase and depressive symptoms will decrease with TUS~     stimulation.~   "
67343|NCT02685475|"~     Background and objectives: The investigators performed this study to explore whether the~     presence of diabetes mellitus (DM) would affect the outcomes of axillary brachial plexus~     blocks (ABPBs) in patients undergoing elective forearm and/or hand surgery. The primary~     hypothesis was that the sensory block duration would be delayed in diabetic patients.~      Methods: After obtaining ethics committee approval and written informed consent, 71 patients~     were enrolled to the study. Diabetic patients were included in Group DM and non-diabetics~     were included in Group NODM. All received ultrasound-guided ABPBs with the mixture of 10 mL~     lidocaine 2% and 20 mL bupivacaine 0.5%. Our primary outcome was sensory block duration, and~     secondary outcomes were sensory and motor block onset times, motor block duration,~     time-to-first-pain (numeric rating scale (NRS) ≥4), postoperative NRS scores and rescue~     analgesic consumption (NRS) ≥4) through the postoperative first 2 days. All outcomes were~     assessed by a blinded investigators.~   "
67344|NCT02685462|"~     This is a Phase 1, Open-Label, 3-Period, Single-sequence, Drug-drug Interaction Study in~     Healthy Subjects to Assess the Effect of Cenicriviroc on the Pharmacokinetics (PK) of HMG-CoA~     Reductase Inhibitors [Rosuvastatin (ROS), Atorvastatin (ATO) and Simvastatin (SIM)], Caffeine~     and Digoxin~   "
67345|NCT02685449|"~     This is a randomized, cross-over study. The aim of this study is to compare the post-prandial~     glycaemic variability after pure protein meal following with an administration of square-wave~     bolus of meal-insulin or without any meal-insulin bolus on the other day.~      Prolonged post-prandial glycaemic variability will be identified using the self-monitoring of~     blood glucose (10-point curve) and CGMS.~   "
67346|NCT02685436|"~     Wheezy infants were tested for gastro-esophageal reflux disease (GERD) using combined~     multiple channel intraluminal impedance-pH (MII-pH), esophagogastroduodenoscope (EGD), lipid~     laden macrophage index and BAL pepsin. Wheezy infants with abnormal MII-pH or reflux~     esophagitis were given domperidone and omeprazole then re-evaluated for symptoms control and~     exacerbations recurrence.~   "
67347|NCT02685423|"~     Amblyopia is an impairment in spatial vision caused by asymmetry in the quality of visual~     input across the two eyes during childhood. It is difficult to treat in adulthood because the~     visual system becomes less plastic (able to learn) with age. The purpose of this study is~     to determine whether five to ten days of visual deprivation--living in complete darkness--can~     enhance plasticity in the visual cortex and thereby facilitate the learning that is needed to~     recover visual function in amblyopic adults.~   "
67348|NCT02685410|"~     As part of Yale's Play2Prevent (www.Play2Prevent.org) program to develop videogame-based~     interventions targeting risk reduction and prevention in youth and young adults, this study~     is designed to develop a paper prototype and intervention design manual of an online~     social-network game, One Night Stan, with the goal of risk reduction and HIV/STI prevention~     in young black women. The ultimate plan is to incorporate focus group participants input and~     feedback into the development of a conceptual model, intervention manual, and videogame~     intervention prototype. This prototype will then be tested using 20 participants and will~     utilize a pre-post design to evaluate the effectiveness of the program.~   "
67380|NCT02684994|"~     This study will take place over approximately 6 months and includes 3 assessment appointments~     (where information will be gathered, but no direct treatment provided) and 12 treatment~     sessions of cognitive processing therapy if eligible.~   "
67349|NCT02685397|"~     This adaptive phase II/III randomized trial is designed to demonstrate that eradication of~     oligometastases by SBRT is a promising and emerging way to delay disease progression and~     postpone second line systemic therapies in castration-resistant prostate cancer (CRPC)~     patients. Only CRPC patients with an oligometastatic recurrence will be eligible to take part~     in this trial. All participating patients will receive either the standard of care (i.e. LHRH~     agonist in combination with the new generation of hormonal therapy [Enzalutamide]) or the~     experimental treatment (i.e. LHRH agonist in combination with the new generation of HT~     [Enzalutamide] plus the additional SBRT treatment). The patients will undergo different~     evaluations before treatment, such as imaging to confirm oligometastatic recurrence and blood~     tests. Patients will be stratified according to the location of metastasis (visceral [with or~     without bone metastases] vs. bone metastases alone) and PSA doubling time (≤ 3 vs. > 3~     months). As per the standard of care, patients will have PSA testing performed every 6-12~     weeks and re-imaging at 6, 9, 12, 18 and 24 months or at PSA progression, whichever occurs~     first.~   "
67350|NCT02685384|"~     This innovative and timely study will measure the impact of Affordable Care Act (ACA)~     Medicaid expansions on diabetes mellitus (DM) prevention, treatment, expenditures and health~     outcomes. To assess this natural policy experiment, the investigators will use electronic~     health record data from the ADVANCE clinical data research network (CDRN) of the National~     Patient-Centered Clinical Research Network (PCORnet).~   "
67351|NCT02685371|"~     This study will evaluate the effect of deep breathing manoeuvres on inter ventricular~     interdependency physiology. By providing further insight in this basic physiology we want to~     add more comprehensive data in favor or not of constrictive pericarditis diagnostic criteria~     currently used in cardiovascular magnetic resonance.~   "
67352|NCT02685358|"~     Posttraumatic Stress Disorder (PTSD) is an often severe and frequently disabling condition.~     It is associated with compromised health, early mortality, and substantial economic costs.~     PTSD is common in VA primary care patients; however, brief, effective treatments for PTSD are~     not available in the primary care setting. Instead, patients with PTSD are referred to mental~     health settings, yet many patients do not accept these referrals or do not adequately engage~     in such services. Thus, this project seeks to improve health care for Veterans by testing the~     effectiveness of a primary care-based treatment called clinician-supported PTSD Coach. In~     this treatment a primary care mental health clinician guides patients in using the PTSD Coach~     mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with~     common PTSD-related concerns. If this treatment is found to be effective at reducing PTSD~     symptoms and increasing use of mental health care, it will provide a tremendous benefit to~     Veterans with PTSD seen in VA primary care.~   "
67353|NCT02685345|"~     The objectives of the study is to evaluate the efficacy and safety of DS-8500a compared with~     placebo in patients with type 2 diabetes mellitus (T2DM) receiving sitagliptin.~   "
67354|NCT02685332|"~     Radiation, Stereotactic Body Radiation Therapy.~   "
67355|NCT02685319|"~     Mapping Human Muscle Satellite Cell Fate By Real-Time Imaging~   "
67356|NCT02685306|"~     The primary purpose of this research study is to see whether adding bavituximab (an~     investigational drug) to the standard chemotherapy drug taxane, will improve the results of~     the treatment for early- stage Triple Negative Breast Cancer followed by Standard- of- Care~     surgery~   "
67357|NCT02685293|"~     This is a randomized, double-blind, placebo-controlled, single-center, chronic-dosing (7~     days), two-period, two-treatment, cross-over study to evaluate the treatment effect of PT003~     compared with that of Placebo MDI on Cardiovascular Hemodynamics following chronic-dosing (7~     days) in subjects with moderate to severe COPD.~   "
67358|NCT02685280|"~     From 1999 onwards, Deep Brain Stimulation [DBS] has been proposed as an alternative to~     capsulotomy in refractory cases of Obsessive-Compulsive Disorder [OCD]. More recently,~     several studies with DBS in patients with major depression have been initiated. In Belgium,~     there is currently a reimbursement for devices for DBS for OCD, but not for rechargeable~     neurostimulators, in these OCD patients.~      Although rechargeable neurostimulators are widely used in spinal cord stimulation for pain~     and DBS for movement disorders, they have not yet been used in DBS for psychiatric disorders~     population. Several possible problems might arise with the use of rechargeable~     neurostimulators in this highly specific population.~      In this prospective study with a before-after design, we would like to determine if the use~     of rechargeable neurostimulators is effective, applicable and safe and capable of diminishing~     the need for neurostimulator replacement procedures.~   "
67359|NCT02685267|"~     This is a prospective randomized phase II clinical trial where patients who are receiving~     enzalutamide in the pre-chemotherapy space are randomized upon objective progression~     (radiographic and/or clinical per PCWG2 criteria) to docetaxel/prednisone alone or the same~     combination plus enzalutamide.~      The primary aim is to evaluate whether continuing enzalutamide in combination with docetaxel~     in patients who failed or progressed while on enzalutamide would increase progression-free~     survival (PFS) by 4 months. The secondary end points are PSA responses, percent of patients~     alive at 1 and 2 years, decline in circulating tumor cells (CTCs), and quality of life (QOL)~     using validated scales.~   "
67360|NCT02685254|"~     This study aims to examine if structured skills training group therapy for ADHD in adults has~     beneficial effects superior to 'treatment as usual' including medication in a controlled~     outpatient setting on clinically relevant outcomes including symptoms, functioning and~     quality of life measures.~      The trial is designed as a multicenter randomized controlled, parallel group study. Patients~     are randomized into 1 of 2 treatment arms with 14-week duration: one arm with initial~     intervention by structured skills training groups by weekly sessions or one with control~     condition (treatment as usual). Then after 15 weeks patients in the control condition arm are~     switched to the active intervention by 14 weeks of structured group therapy. All patients are~     assessed for defined outcomes after six months.~   "
67375|NCT02685059|"~     To date no targeted agents are available to treat TNBC. Therefore chemotherapy is the only~     treatment option. TNBC often has a high amount of tumour infiltrating lymphocytes.~     Stimulating the immune cells of TNBC might therefore be an option for these patients to~     increase the pathological complete response. pCR is highly correlated with outcome in TNBC.~      Therefore the addition of a checkpoint inhibitor in addition to chemotherapy might be an~     additional option for these patients.~   "
67361|NCT02685241|"~     Breath analysis is a non-invasive procedure to detect and monitor diseases and it is~     particularly attractive for patients who have to routinely check biomarkers, such as~     diabetics (blood glucose) or end-stage renal disease patients (creatinine). Preliminary data~     in a small study with healthy subjects showed a high correlation between blood glucose levels~     and acetone. Therefore, the objective of this study is to correlate biomarkers (glucose level~     and creatinine, respectively) with the corresponding target breath components (acetone and~     NH3, respectively) detected by portable gas sensors in the general population and to assess~     possible predictive models for biomarker estimations from the corresponding target breath~     component and predictive models to estimate abnormal biomarker concentrations.~   "
67362|NCT02685228|"~     The purpose of this study is to investigate the effect of very low dose decitabine combinate~     with gemcitabine in the first-line treatment of locally advanced, unresectable and metastatic~     pancreatic cancer.~   "
67363|NCT02685215|"~     Muscular dystrophies are neuromuscular disorders with disability. Restrictive pulmonary~     failure and cardiomyopathy affect prognosis.The investigators aim to establish predictive~     factors for mortality and morbidity in Intensive care unit (ICU ) and to describe the long~     term follow up after ICU discharge.~   "
67364|NCT02685202|"~     The purpose of this study is to characterize the course of temporomandibular disorder (TMD)~     pain in adults with TMD and obstructive sleep apnea (OSA), all of whom are being treated with~     mandibular advancement splint (MAS) therapy.~      Study participants are 12 adults with painful TMD and comorbid mild to moderate OSA~     (apnea-hypopnea index ≥5 and <30).~      This is an interventional study in which 12 patients receive MAS therapy for comorbid TMD/OSA~     for 16 weeks. It is standard of care to treat mild or moderate OSA with MAS therapy, the the~     effect on MAS therapy on TMD pain in people with OSA is unknown. There is no comparison~     group. Care is being provided under the direction of a sleep physician by a dentist who~     specializes in dental sleep medicine. The investigators expect that as MAS therapy reduces~     the severity of OSA, painful TMD symptoms will also reduce.~   "
67365|NCT02685189|"~     The purpose of this protocol is to provide a mechanism to collect Long Term Clinical Data~     from those babies who participated in the primary Study 64,185-06-2(W)(WS)(ISNHP) An~     Open-Label Study Of The Safety And Clinical Pharmacology Of Stanate® In Infants At-Risk For~     Exchange Transfusion.~   "
67366|NCT02685176|"~     This Clinical trial is being conducted to study the effectiveness of heat donation through~     head or torso in hypothermic rewarming efficacy using a human model for severe hypothermia.~     The purpose of the study is to compare the core rewarming effectiveness of the same amount of~     heat donation through the head or torso in treatment of hypothermia using a human model for~     severe hypothermia. The information obtained from this study will give a better understanding~     of heat-transfer mechanisms. This might help in the ongoing research in hypothermia~     treatment.~   "
67367|NCT02685163|"~     Formation of reactive oxygen species (ROS) contributes to pathogenesis and progression of~     several diseases. Polyphenols, have been shown to be beneficial against ROS.~      This study evaluate the effects of a natural antioxidant ice-cream,rich in polyphenols, on~     oxidative stress, vascular function and physical performance. In this controlled,~     single-blind cross-over study, 14 healthy subjects were randomized to assume 100 mg of~     antioxidant ice-cream consisting of dark cocoa powder, extract of hazelnut and green tea, or~     milk chocolate ice-cream (control ice-cream). Subjects were studied at baseline and two hours~     after the ingestion of the ice-creams. Serum polyphenols, antioxidant status (ferric reducing~     ability of plasma, FRAP), NO bioavailability (NOx), markers of oxidative stress (D-Roms and~     H2O2), endothelium function (FMD and RHI) and exercise tolerance (Stress Test) with~     measurement of the double product were assessed.~   "
67368|NCT02685150|"~     Endoscopic Tri-Modal Imaging which combines Narrow-band Imaging(NBI), Autofluorescence~     Imaging (AFI) and White-light Imaging (WLI) could be used to identify the indistinct changes~     in the gut caused by reflux disease,either acid reflux or bile reflux, which make it possible~     to differentiate reflux disease from functional dyspepsia (FD).~   "
67369|NCT02685137|"~     This is a randomized, sham-controlled (placebo) trial of a single intramuscular injection of~     Stannsoporfin compared to sham (placebo) in healthy term and near-term newborns admitted to~     the well-baby nursery and enrolled with intention to treat.~   "
67370|NCT02685124|"~     This study evaluates the effect of intake of two orange juice varieties in healthy adults.~     The participants will receive Bahia orange juice, Cara-Cara orange juice or a isocaloric~     control drink in a cross-over study.~   "
67371|NCT02685111|"~     To compare the efficacy and safety of Day 2 (D2) once a cycle pegfilgrastim with Intermittent~     Every Other Days of 5 Shot (D3-11) filgrastim in early breast cancer patients treated with~     adjuvant Docetaxel, Doxorubicin, and Cyclophosphamide (TAC) regimen~   "
67372|NCT02685098|"~     Patients undergoing semi-elective below knee amputation from complications associated with~     atherosclerotic limb ischemia will received intra-muscular injections of allogeneic~     Mesenchymal Stromal Cells in the leg above and below the point of amputation to prevent~     ischemic wound complications after surgery and decrease the incidence of conversion from~     below knee to above knee amputation.~   "
67373|NCT02685085|"~     Induction of labor is performed via the vaginal misorostol 25 ug/ 6 hours and intracervical~     foley's cather administration and both techniques performed together.~   "
67374|NCT02685072|"~     This will be a double-blind, placebo-controlled, pilot, randomized clinical trial. A total of~     50 women who smoke and have regular menstrual cycles will be randomized to either~     progesterone (200 mgs BID) + Transdermal Nicotine Patch (TNP) or placebo + TNP for 8 weeks.~     TNP will be tapered after 4-6 weeks. Progesterone or matching placebo will be discontinued at~     the end of Week 8. All participants will also be provided behavioral treatment for smoking~     cessation. Participants will be inducted onto progesterone (or placebo) + TNP over a one-week~     period (Week 1) during the mid luteal phase, within a week before menses and the target quit~     date will be set for the 5 (+/-2) days after onset of menses. Participants will have~     post-trial follow-up visits at 1 and 3 months.The main study outcomes will be self- report of~     smoking abstinence, biochemically verified smoking abstinence, measures of cigarette craving~     and nicotine withdrawal, and measures of response inhibition.~   "
67376|NCT02685046|"~     In this proof-of-concept trial the investigators will study the effects of imatinib treatment~     on the biology of mesenchymal-type colon cancers.~   "
67381|NCT02684981|"~     The aim of this non-interventional study is to describe patient's perception of anticoagulant~     treatment when using Pradaxa to prevent stroke and systemic embolism while suffering from~     atrial fibrillation (according to its approved indication in the approved dosages of 110~     milligrams or 150 milligrams twice daily) in comparison to standard care using Vitamin K~     Antagonist (VKA).~   "
67382|NCT02684968|"~     Eligible patients will be randomized 1:1 without stratification to bilateral continuous QL~     catheters with local anesthetic continuous infusion (QL block + IV patient-controlled~     analgesia group) or normal saline continuous infusion (IV patient-controlled analgesia~     group).~      In the postanesthesia care unit (PACU), patients will be given intravenous boluses of~     hydromorphone or fentanyl as needed. Following immediate recovery from anesthesia, patients~     will be provided with a hydromorphone IV patient-controlled analgesia pump with standard~     initial settings and an option of clinician dose for breakthrough pain. IV patient-controlled~     hydromorphone pump settings will be titrated to comfort level (pain score<4) by blinded~     clinicians.~      Each of the catheters will be connected to patient controlled infusion pump running at a~     basal rate of 6mL/hour of 0.1% Bupivacaine or normal saline with on-demand bolus of 5 mL~     every 60 minutes to be started in the operating room before the surgical incision.~      Opioid consumption first 72 hours or until discharge, whichever comes first will be recorded.~      Pain scores during first 72 hours or until discharge, whichever comes first will be recorded~     with a verbal rating scale and obtained from the patient's electronic medical records.~      The morning of post operative day 1 and post operative day 3 the ORSDS and QOR surveys will~     be completed.~      Morning of the day of discharge, the overall patient satisfaction with pain management survey~     will be completed.~   "
67383|NCT02684955|"~     Cardiac arrest remains a leading cause of death, currently affecting >250,000 Europeans~     outside the hospital each year. Manual cardiopulmonary resuscitation (CPR) provides between~     15 to 30 % of normal blood flow to the heart and brain. For out-of-hospital cardiac arrest,~     the return of spontaneous circulation (ROSC) is possible only for 20-40% of patients with~     trained resuscitation teams. However, only 5-10% of patients will survive with good~     neurological status. A good quality CPR, a short time before initiation of the resuscitation~     and a short delay before the first defibrillation have been associated with improved~     neurological outcome. Unfortunately it is currently impossible to obtain reliable information~     on the quality of the perfusion and oxygenation of organs during CPR. The current monitoring~     during CPR is limited to heart rhythm analysis, pulse rate evaluation and end tidal CO2~     (EtCO2). The last one is the only parameter which have been linked with probability of ROSC~     and its value gives no indication of the long-term prognosis nor the neurological status.~      Cerebral spectroscopy (near-infrared spectroscopy - NIRS) allows to measure with a~     noninvasive method the local oxygen saturation of the prefrontal cortex (rSO2), reflecting~     the balance between need and supply of brain oxygenation. This technique has been recently~     used in cardiac arrest showing a possible association between rSO2 measured during CPR and~     the occurrence of ROSC or survival. The quantitative measurement of the pupillary light~     reaction has been described to predict neurological outcome in the hospital for patient~     successfully reanimated after out-of-hospital cardiac arrest (OHCA). Recently, a feasibility~     study has shown that its use was also possible during CPR in the pre-hospital setting.~      The investigators aim to study a composite prognostic factor combining quantitative rSO2 and~     automated pupillometry measured during CPR. The investigators hypothesized that the rate of~     survival with good neurologic outcome at 30 days will be lower in patients with rSO2 <30% for~     more than 5 min and an absent pupillary reflex more than 5 min or decreasing during CPR .~   "
67384|NCT02684942|"~     Purpose: To compare the pain level and quality of life of the two sedation regimens~     consisting of diazepam in combination with meperidine or fentanyl.~      Materials and methods: A total of 40 patients (160 sessions of brachytherapy), unselected~     brachytherapy out patients at Chulabhorn Hospital, Thailand were enrolled with informed~     consent and randomized to receive meperidine or fentanyl. Data of perceived pain (according~     to standard 10-cm visual analog scales [VAS]), and perceived Quality of life (EQ-5D) were~     collected. Patients and all brachytherapy staffs directly involved with the procedure were~     blinded about the drug used.~   "
67385|NCT02684929|"~     Branched-chain amino acids (BCAA) belong among nutrients strongly linked with insulin~     sensitivity (IS) measures. Their exact effect on IS appears to be dependent on various~     conditions that remain to be better defined . The aim of the current study was to investigate~     effects of chronic increase of BCAA intake on IS in two groups of healthy subjects differing~     in their basal consumption of BCAA, i.e. vegans and omnivores. Interventional trial was~     designed where vegans and omnivores were separately interveined with 15 (women) or 20 (men)~     grams of BCAA daily. Examinations of participants are intended to be done at baseline, after~     the intervention and wash-out period. Examinations (anthropometry,~     hyperinsulinaemic-euglycaemic clamp, arginine test) and blood analyses will be performed at~     baseline, after the intervention and after a 6 month wash-out period. Samples of subcutaneous~     abdominal adipose tissue (AT) and skeletal muscle (SM, vastus lateralis) obtained before and~     after the intervention will be used for various analyses (mRNA levels of selected metabolic~     markers, fatty acid composition, mitochondrial activity).~   "
67386|NCT02684916|"~     The primary aim of the study is to assess the effectiveness of chiropractic manipulation~     treatment versus placebo treatment in children suffering from headache for more than six~     months.~   "
67387|NCT02684903|"~     This is a randomized, controlled trial of Parent-Child Interaction Therapy (PCIT) designed to~     test the effects of PCIT on self-regulation and behavior in child maltreating (CM) parents~     and their elementary-school children. Two hundred-fifty (250) maltreating mothers and their~     children (age 5-8 years) will be drawn from Child Protective Services and randomized to the~     PCIT intervention or a control condition (services as usual). Key contextual risk factors~     will be assessed, including cumulative risk, parent mental health, and parent substance use.~     A multirater, multimethod approach to assessment will include measures of self-regulation,~     parenting skills and children's behavior outcomes. Families will be followed to 1 year for CM~     recidivism. Findings from this proposed study are expected to have significant implications~     for optimizing CM parenting interventions by (a) determining the sensitivity of CM parent and~     child neurobehavioral self-regulation systems to intervention, and (b) identifying individual~     differences in self-regulation that mediate and moderate response to intervention and~     long-term maintenance of gains.~   "
67388|NCT02684890|"~     Tinnitus may affect the ability of patients to detect emotions in spoken language. This study~     will compare this ability between tinnitus patients and non-tinnitus patients.~   "
67389|NCT02684877|"~     The investigators contacted consecutive adult patients admitted to intensive care unit (ICU)~     and mechanically ventilated for at least 72 hours to invite them to an interview at hospital.~     The investigators administered Mini Mental Status Examination, Functional Assessment of~     Chronic Illness Therapy scale for Fatigue (Facit- F) and Short form 36 questionnaires to the~     consenting patients.~   "
67416|NCT02684526|"~     To examine the quality of liver images produced when the contrast agent Eovist is used during~     MRI.~   "
67390|NCT02684864|"~     Adults with degenerative meniscal tear receiving arthroscopic surgical management or knee~     drainage (arthrocentesis) +/- intra-articular steroid injection will be recruited to this~     non-interventional cohort study. The aim is to investigate whether measurement of an~     individual's synovial fluid biomarker response to a degenerative meniscal tear with symptoms~     predicts symptomatic and functional outcome suggestive of osteoarthritis (OA) of the knee.~   "
67391|NCT02684851|"~     The purpose of this study is to determine if patients undergoing acetabular ORIF (open~     reduction with internal fixation) who receive tranexamic acid have a reduced risk of~     allogenic blood transfusion, perioperative blood loss, wound complication and higher risk for~     thromboembolic events compared to patients who receive placebo. Investigators want to~     determine the cost-effectiveness related to allogenic blood transfusion as a blood loss~     management strategy in acetabular open reduction internal fixation (ORIF). Orthopaedic~     surgery carries with it a significant risk for blood loss. Current management of~     perioperative blood loss is the use of allogenic blood transfusion. Allogenic blood~     transfusion carries with it a risk for HIV and Hepatitis C as well as multiple adverse~     reactions. There have been significant efforts to reduce the use of allogenic blood~     transfusion in orthopaedic surgery. Tranexamic acid, an anti-fibrinolytic agent, has been~     used in management of blood during surgery. In order to determine the impact of tranexamic~     acid in reducing blood loss among patients undergoing acetabular ORIF, investigators will~     conduct a prospective randomized study. Patients undergoing acetabular surgery will be~     screened for this study. Patients will be then randomized to placebo or tranexamic acid which~     will be administered during and after surgery. The following data will be collected: patient~     characteristics, surgery information, blood loss, blood transfusions, wound complication~     within 30 days of surgery, and cost.~   "
67392|NCT02684838|"~     This is a prospective, observational registry in patients who have been prescribed Gliadel~     Wafer by the physician as part of usual care.~   "
67393|NCT02684825|"~     The primary objective of this study is to evaluate whether, in patients with first-ever~     atherothrombotic or lacunar stroke without any previous history of atrial fibrillation~     (AF)/atrial flutter (AFL)/atrial tachycardia (AT), the detection of AF/AFL/AT (silent or~     symptomatic) by using a continuous cardiac rhythm monitoring with implantable loop recorder~     (ILR) during the first 12 months of observation is higher than the detection by using a~     standard cardiac monitoring (physical exam, 12-lead electrocardiogram [ECG] at baseline, 3,~     6, and 12 months and Holter ECG at 3 months) in the same period of time.~   "
67394|NCT02684812|"~     This is a multicenter, prospective, randomized, open-label trial with blinded endpoint~     (PROBE) assessment. Adult patients with the diagnosis of non-traumatic SAH, as proven by~     computed tomography (CT) within 24 hours after the onset of headache, will be randomly~     assigned to the treatment group or the control group. Patients in the treatment group will~     receive standard treatment with the addition of a bolus of TXA (1 g intravenously)~     immediately after randomization, followed by continuous infusion of 1 g per 8 hours until the~     start of aneurysm treatment, or a maximum of 24 hours after the start of medication. Patients~     in the control group will receive standard treatment without TXA. The primary outcome measure~     is favorable functional outcome, defined as a score of 0 to 3 on the modified Rankin Scale~     (mRS), at 6 months after SAH. Primary outcome will be determined by a trial nurse blinded for~     treatment allocation.~   "
67395|NCT02684799|"~     This is a Phase 1, Single and Multiple-Dose, Open-Label Study in Healthy Subjects to Assess~     the Effect of the Acid Reducing Agents, Omeprazole and Famotidine, on the PK of CVC~   "
67396|NCT02684786|"~     Pulmonary hypertension Group 2 (PH 2) associated with left-sided heart disease is relatively~     common, is associated with a poor prognosis, and unfortunately there are no proven medical~     treatments beyond attempts at correcting the left sided heart disease. Many PH 2 patients~     have evidence of active constriction of blood vessels from increased nerve traffic. Use of~     agents or procedures which produce a reversible chemical blockage of this nerve traffic have~     not been systematically tested in PH 2. The investigators will test whether acute~     interruption of sympathetic nervous system tone, which local anesthetic block of the stellate~     ganglion in the neck, will improve PH2, and also test whether the high blood pressure drug~     reserpine, which blocks sympathetic nerve activity, will do so during a one month trial~     period.~   "
67397|NCT02684773|"~     Background: In 2010, approximately 39000 Canadians had end-stage renal disease (ESRD), and~     the prevalence rate of dialysis has increased by 189% over the past 2 decades. The annual~     mortality rate remains high at ~15%, and cardiovascular events are the leading cause of~     death. Intensification of conventional dialysis schedules has been the major focus in recent~     years. Currently, most Canadian dialysis patients receive conventional in-center hemodialysis~     (CHD), which is administered as a 3-4 hour session 3/week. Recent research has focused on~     home nocturnal hemodialysis (8 hours of hemodialysis at home for 5-6 nights/week), which may~     have substantial cardiovascular benefits, including regression of left ventricular (LV)~     hypertrophy, improved LV ejection fraction and enhanced blood pressure control. Nevertheless,~     this dialysis modality is only feasible in a highly selected minority of ESRD patients who~     can self-manage their dialysis treatment at home. In-center nocturnal hemodialysis (INHD),~     administered as 7-8 hours of hemodialysis in hospital for 3nights/week, represents a~     promising and practical alternative for many dialysis patients. In a Canadian Institutes for~     Health Research (CIHR) supported cohort study, the investigators have recruited 67 patients~     and have completed 1-year follow-up. There is a compelling need for longer-term follow-up,~     since all the published randomized controlled trials are of short duration (6-12 months),~     while renal replacement therapy is a life-long treatment. Furthermore, the observed large~     variability of cardiac remodeling in individual ESRD patients remains poorly understood.~     Therefore, the current study is an extended follow-up phase (5 years from enrollment) on the~     completed 1-year follow-up period and the purpose of this study is to objectively evaluate~     the long-term effects of more intensified hemodialysis treatment which the INHD modality~     offers.~      Need for Long-term and Generalizable Data: In contrast to the seminal Alberta trial which~     showed a significant LV mass reduction with home nocturnal hemodialysis, the recently~     reported Frequent Hemodialysis Network Nocturnal Trial demonstrated only a trend toward~     reduction in LV mass. It is likely that the highly selected participants, inadequate trial~     power and duration (12 months) account for the observed results. Currently, it is unknown~     whether INHD, which is less intensive but more feasible for most ESRD patients, is associated~     with similar cardiovascular benefits in the long term.~      Objective:~        1. To determine the long-term effects of INHD on (i) LV mass; (ii) global and regional LV~          systolic and diastolic function; (iii) myocardial tissue characteristics; (iv) left~          atrial structure and function; (v) selected cardiovascular biomarkers in ESRD patients.~        2. To examine the determinants and mechanisms of cardiac remodeling in ESRD~      Hypothesis: Conversion to INHD is associated with sustained improvements in cardiovascular~     structure and function, as compared to conventional hemodialysis (CHD) in patients with~     end-stage renal disease (ESRD).~      Study Design and Population: This will be a 2-centre, prospective, longitudinal cohort study~     of 67 adult ESRD patients (INHD subjects and CHD controls) enrolled in the original study.~     All eligible participants who provide consent will undergo cardiac Magnetic Resonance Imaging~     (MRI) examination and bloodwork at 5 years since enrollment in the study. Other follow-up~     procedures include the following -electrocardiogram, transthoracic echocardiogram, ambulatory~     blood pressure monitoring, lateral x-ray of the aorta, and completion of questionnaires.~      Outcome: The primary endpoint is the change in LV mass over 5 years, as measured by cardiac~     MRI. Secondary endpoints include LV size, global and regional diastolic and systolic~     function, left atrial size and function, changes in myocardial tissue characteristics, blood~     pressure, serum troponin, norepinephrine, Brain Natriuretic Peptide (BNP), high sensitivity~     C-Reactive Protein (hsCRP), interleukin-6, matrix metalloproteinases, fibroblast growth~     factor-23, fetuin-A, transforming growth factor-beta, connective tissue growth factor,~     clinical events, and quality of life.~      Significance: The provision of an enhanced dialysis regimen has emerged as the most promising~     avenue through which to modify the dismal cardiovascular outcomes in patients receiving~     chronic hemodialysis. INHD represents a means of administering such therapy to a broad~     spectrum of dialysis patients for whom home therapies would not be feasible. This study will~     be the first to precisely define the long-term cardiac effects of intensified dialysis and to~     elucidate the mechanisms of cardiac remodeling in ESRD, using cardiac MRI and other novel~     biomarkers. These important observational findings may have a major impact on the optimal~     management and outcome of ESRD patients in the real world.~   "
67398|NCT02684760|"~     PF-06651600 is being developed for treatment of inflammatory bowel disease. This study will~     test the bioavailability of a solid dose formulation of PF-06651600 compared to an oral~     solution formulation under fasting conditions and the effect of a high fat meal on the~     bioavailability of the solid dose formulation of PF-06651600 in healthy subjects. Safety and~     tolerability of the tablet and oral solution formulations of PF-06651600 will be assessed~     under fasting and fed conditions.~   "
67399|NCT02684747|"~     A total of 40 subjects will be recruited for participation in this study. 20 subjects (10~     males and 10 females) will be randomized to the active group (those receiving re-infusion of~     autologous blood) and 20 subjects (10 males and 10 females) will be randomized to the placebo~     group (receiving NS infusion).~   "
67400|NCT02684734|"~     Colitis from reactivation of established cytomegalovirus (CMV) colonization can complicate~     the clinical course in patients with an acute flare of ulcerative colitis (UC). Accurate and~     timely detection of active CMV infection or disease with appropriate anti-viral therapy may~     reduce complications associated with acute UC flare. Limited information is available on the~     presence of colonic CMV infection in patients with quiescent ulcerative colitis. Prospective~     studies on factors associated with reactivation of CMV infection during active UC flare and~     its impact on disease progression are lacking.~      The hypothesis of this study are as follows: 1) CMV infection is prevalent in patients with~     ulcerative colitis irrespective of disease severity; 2) The degree of immunosuppression~     directly impacts CMV infection status in patients with ulcerative colitis~   "
67401|NCT02684721|"~     In a randomised design the study aims to investigate whether an intervention of 8 weeks~     home-based exercise in addition to usual care can positively influence the physical capacity,~     quality of life, sick leave and use of psychoactive drugs in patients medically treated for~     pulmonary embolism.~   "
67451|NCT02684058|"~     The purpose of this study is to investigate the activity of dabrafenib in combination with~     trametinib in children and adolescent patients with BRAF V600 mutation positive low grade~     glioma or relapsed or refractory high grade glioma.~   "
67402|NCT02684708|"~     The EuroNet-PHL-C2 trial is an international, multicentre, randomised controlled trial with~     the aims to reduce the indication for radiotherapy in newly diagnosed patients with classical~     Hodgkin lymphoma without compromising cure rates and to investigate a chemotherapy~     intensification randomisation in intermediate and advanced classical Hodgkin lymphoma to~     compensate for reduction in radiotherapy.~   "
67403|NCT02684695|"~     This observational study aims to develop and validate quantitative magnetic resonance imaging~     biomarkers as measures of disease activity in juvenile idiopathic arthritis (JIA). This~     includes patients with enthesitis-related arthritis (ERA).~   "
67404|NCT02684682|"~     The purpose of this blind randomized clinical trial is to evaluate different frequencies in~     self-mechanical control of plaque in individuals with historic of periodontitis and in~     periodic and preventive maintenance in order to assess which frequencies are compatible with~     maintaining gingival health.~   "
67405|NCT02684669|"~     In several rodent studies, it has been demonstrated that very high doses of opioid~     antagonists (i.e., naloxone 3-10 mg/kg) administered after weeks after recovery from an~     inflammatory injury may lead to a reinstatement of hyperalgesia and pain behavior. This~     latent sensitization has recently been demonstrated also to take place in humans.~      The present study examines if it is possible to foresee individuals who will demonstrate a~     larger degree of latent sensitization upon challenge with an injury, than others. Using an~     enriched design high sensitizers (e.g., the upper quartile of individuals developing large~     areas of secondary hyperalgesia following a mild burn injury) are compared with low~     sensitizers (lower quartile), regarding the propensity for developing latent sensitization~   "
67406|NCT02684656|"~     The health care burden of CKD is substantial and growing with 10-15% of the population~     affected in both developed and developing countries. It is well established that CKD is~     associated with systemic inflammation, which promotes cardiovascular disease and body~     wasting. However, causal therapies to treat systemic inflammation, and treat its adverse~     consequences remain sparse. As kidney function declines in all forms of CKD, oxalate levels~     increase in the plasma, leading to increased systemic exposure to oxalate and consequent~     tissue injury. Work from the investigators has shown that elevated plasma oxalate levels~     activate the NLRP3 inflammasome which in turn leads to the processing and release of~     cytokines. The investigators seek to test the hypothesis that oxalate contributes to the~     systemic inflammation observed in patients with end-stage renal disease (ESRD). The~     investigators plan to define the association between plasma oxalate levels and signs of~     systemic inflammation in patients on hemodialysis. In a second step the investigators will~     examine whether hemodiafiltration lowers plasma oxalate more efficiently than hemodialysis~     and reduces signs of systemic inflammation. Confirmation of the hypothesis may lead to the~     identification of oxalate as a novel therapeutic target for interventional trials aimed at~     reducing plasma oxalate in patients with ESRD.~   "
67407|NCT02684643|"~     This study is designed to study and compare the efficacy and cost-effectiveness of~     individualized phosphate-lowering therapy in comparison with regular guideline-recommended~     therapy.~   "
67408|NCT02684630|"~     The purpose of this study is to optimize collected platelet yields in single and double~     platelet collections, while maintaining donor postplatelet count of >100,000/µL.~   "
67409|NCT02684617|"~     This is a non-randomized, open-label study evaluating the safety and efficacy of~     pembrolizumab (MK-3475) used in combination with dinaciclib (MK-7965) in the treatment of~     relapsed or refractory chronic lymphocytic leukemia (rrCLL), multiple myeloma (rrMM), or~     diffuse large B-cell lymphoma (rrDLBCL) in up to 138 participants from multiple sites.~      During an initial Dose Evaluation phase (first 2 cycles) to determine Dose Limiting~     Toxicities (DLTs), dose combinations of pembrolizumab 200 mg followed by dinaciclib 7 mg/m^2,~     pembrolizumab 200 mg followed by dinaciclib 10 mg/m^2, and pembrolizumab 200 mg followed by~     dinaciclib 14 mg/m^2 will be evaluated. Following safety review of the Dose Evaluation Phase,~     approximately 30 participants each will be enrolled in rrCLL, rrMM, or DLBCL cohorts during~     the Signal Detection phase. For each disease type objective response rate (ORR) will be~     determined by disease specific criteria.~      The rrMM cohort was closed to enrollment on 07-AUG-2017 due to lack of efficacy.~   "
67410|NCT02684604|"~     Prevalence of anti-H.pylori IgG in serum of women with unexplained infertility and comparing~     that with it's prevalence in fertile women.~   "
67411|NCT02684591|"~     A subset of patients with NAFLD that have not been extensively studied are those infected~     with human immunodeficiency virus (HIV). Currently, there is no FDA approved treatment for~     NAFLD or NASH. Additionally, there have been no significant clinical trials for HIV patients~     with NAFLD and there are no approved treatment options. We plan to conduct a randomized,~     double-blinded, placebo-controlled clinical trial to examine the efficacy of 600 mg of~     Aramchol daily (including 200 mg tablet and 400 mg tablet) versus identical placebo given~     over 12 weeks to improve HIV-associated hepatic steatosis as measured by a validated and~     accurate magnetic resonance imaging (MRI)-based technique.~   "
67412|NCT02684578|"~     The purpose of this study is to determine whether metformin, an FDA-approved drug for the~     treatment of type II diabetes, is a safe and effective treatment to decrease the progression~     of geographic atrophy in non-diabetic patients with Age-related Macular Degeneration (AMD).~   "
67413|NCT02684565|"~     Branching chain amino acids (BCAA) have both beneficial and detrimental effects of on~     metabolism have been established and therefore warrants further investigation. In the~     preliminary study, the investigators found that BCAAs enhanced glucose metabolism in lean~     mice while they promoted glucose intolerance in obese mice. In lean mice, BCAAs decreased~     adiposity and enhanced glucose utilization and insulin sensitivity in different tissues. But~     in obese mice, BCAAs' effects were mediated by impaired insulin signaling in fat tissue.~      This study will examine 10 obese subjects with pre-diabetes and examine the effects of taking~     BCAA supplement and will monitor the subjects blood glucose, insulin, triglyceride levels and~     will have an oral glucose tolerance test on repeated occasions to see if any changes are~     noted in their glucose regulation.~   "
67414|NCT02684552|"~     Patients with cystic fibrosis older than 18 years will performance a Bruce test with non~     invasive ventilation (once) after 30 minutes they perform the same test with oxygen~     supplementation.~      Measurements: Transcutaneous level off carbon dioxide, saturation, puls and dyspnea scale.~   "
67415|NCT02684539|"~     syncope prediction on tilt table~   "
67417|NCT02684513|"~     For more than 15 years, traditional fasting regimens prior to scheduled surgeries have been~     called into question, yet prolonged preoperative fasting remains common practice. While~     prolonged fasting is aimed at reducing the risk of pulmonary aspiration, prolonged fasting is~     uncomfortable, has an inconsistent effect on gastric volumes and acidity and may lead to~     dehydration without a clear reduction in the incidence of aspiration. Fasting by itself~     decreases hepatic glycogen stores, induces a state of insulin resistance and impairs~     cardiovascular function. Yet, prolonged preoperative fasting remains common.~      Preoperative oral carbohydrate (CHO) consumption improves insulin sensitivity and decreases~     the time to return of gut function without increasing gastric volumes or acidity compared to~     other clear liquids and fasting. Previous work has shown oral CHO consumption improves~     patient well-being to a greater degree than placebo drink (water or flavored water) and~     fasted controls. Oral CHO also outperforms a similar volume of intravenous glucose~     supplementation. These benefits have reduced hospital stays in a variety of surgical models~     by as much as 20%. Further, preoperative CHO supplementation improved postoperative patient~     hunger, thirst, anxiety, fatigue and nausea.~      The purpose of this research study is to determine if drinking a high carbohydrate beverage~     before cesarean section surgery can improve patient well-being, compared to patients who~     drink a low carbohydrate beverage or fast before surgery.~   "
67418|NCT02684500|"~     The purpose of this research study is to determine if the diameter and flow of the superior~     mesenteric artery in patients with aneurysmal subarachnoid hemorrhage undergoing hypertensive~     therapy for cerebral artery vasospasm are effected enough to justify withholding enteral~     nutrition.~   "
67419|NCT02684487|"~     Sepsis is a clinical entity that complicates infection. Without early recognition and timely~     management, it can rapidly progress to severe sepsis, septic shock, and culminate in multiple~     organ dysfunction syndrome. Forty to 70% of septic patients have low vitamin D status, yet~     little is known about the impact of vitamin D3 (vitD3) supplementation in this patient~     population. As such, the investigators propose a randomized, double-blinded,~     placebo-controlled trial to test the hypothesis that early, rapid correction of low vitamin D~     status, as an adjunct to established treatment guidelines, will improve clinical outcomes and~     measurably alter immune profile in patients with severe sepsis.~   "
67420|NCT02684474|"~     The purpose of this protocol is to provide treatment with HBOC-201 to patients with~     life-threatening anemia for whom allogeneic blood transfusion is not an option. HBOC 201~     [hemoglobin glutamer - 250 (bovine)] has been previously studied as an alternative to blood~     transfusions in severely anemic patients needing a way to enhance tissue oxygenation.~     HBOC-201 is purified, cross-linked and polymerized acellular bovine hemoglobin in a modified~     lactated Ringer's solution, and does not require blood compatibility.~   "
67421|NCT02684461|"~     The purpose of this research study is to test the effectiveness of three treatment arms that~     are designed to improve survival in patients with non-small cell lung cancer. Eligible~     subjects could be randomized to four (4) cycles of chemotherapy followed by immunotherapy, or~     immunotherapy followed by chemotherapy, or four cycles of chemotherapy plus immunotherapy.~   "
67422|NCT02684448|"~     This multi-center, retrospective data collection study will evaluate the feasibility, safety~     and performance of the da Vinci® surgical system for patients who have undergone~     robotic-assisted inguinal hernia repair, as well as provide information about the learning~     curve associated with robotic-assisted (da Vinci®) inguinal hernia repair.~      In addition, this retrospective data collection study will evaluate the perioperative~     outcomes of robotic-assisted (da Vinci®) inguinal hernia repair and compare perioperative~     outcomes with those associated with open hernia repair by the same participating surgeon.~   "
67423|NCT02684435|"~     The purpose of this research study is to evaluate contrast-enhanced ultrasound for kidney~     malignancies~   "
67424|NCT02684422|"~     This study aims to examine features of MRSA that are associated with chronic MRSA infection~     and bacterial persistence despite IV antibiotic therapy. Subjects are asked to expectorate~     sputum and complete CF symptom diaries both at beginning and end of IV therapy.~   "
67425|NCT02684409|"~     This will be a Phase 1, multiple center, open label, single-dose study in otherwise healthy~     adolescent subjects with a history of acute migraine. Subjects will each receive one Zecuity~     patch application. Subjects will be admitted 2 hours prior to dosing on Day 1, and will~     remain in the clinical unit under supervision until the last pharmacokinetic (PK) sample is~     obtained. Blood will be obtained at prescribed times for PK analysis and safety assessments~     will be performed, including adverse event monitoring, 12-lead ECG test, patch adhesion~     evaluations, skin irritation evaluations, and vital signs.~   "
67426|NCT02684396|"~     The purpose of this study is to determine the safety, tolerability and pharmacokinetics of~     TAK-648 when administered as a single oral dose of TAK-648 solution at escalating dose levels~     in healthy participants.~   "
67427|NCT02684383|"~     Infection with dengue viruses is the leading cause of hospitalization and death in children~     in many tropical Asian countries, and the development of a dengue vaccine is a top health~     priority. This study will evaluate the safety and immunogenicity of a live attenuated~     monovalent dengue virus vaccine (rDEN3Δ30) in healthy adults with no history of previous~     flavivirus infection.~   "
67428|NCT02684370|"~     This is a randomized double blind, double dummy, placebo and active comparator controlled,~     parallel design study that is being performed to assess the safety and efficacy of BI~     655066/ABBV-066 (risankizumab) to support registration for the treatment of moderate to~     severe chronic plaque psoriasis in adult patients.~   "
67429|NCT02684357|"~     This is a randomized double blind, double dummy, placebo and active comparator controlled,~     parallel design study that is being performed to assess the safety and efficacy of BI 655066~     to support registration for the treatment of moderate to severe chronic plaque psoriasis in~     adult patients.~   "
67430|NCT02684344|"~     This randomized open-label study will be comprised of 2 cohorts: one control group and one~     treatment group. The trial will be conducted as an open label randomized trial to evaluate~     the efficacy of tamsulosin in the prevention of post-operative urinary retention. The study~     will include pre- and post-surgical evaluations of patients including symptoms of urinary~     retention and any adverse effects contributable to the study medication.~   "
67452|NCT02684045|"~     The purpose of this chart review is to assess outcomes in subjects that received MAGNIFUSE in~     the posterolateral lumbar spine at 1 or 2 continuous levels from L1-S1.~   "
67431|NCT02684331|"~     The study will be performed as a cross-sectional survey. 300 Type 2 diabetes patients (T2DM),~     with or without known cardiovascular disease, will be recruited from the diabetes outpatient~     clinic, Slagelse Hospital. The patients will undergo echocardiography, Cardiac magnetic~     resonance imaging (CMR), clinical examination and will be asked to fill out questionnaires.~      This study project sets out to answer the following hypotheses:~        1. Patients with T2DM have an increased risk of developing diastolic dysfunction. Using~          CMR, the investigators wish to measure left ventricle peak filling rate and passive~          atrial emptying fraction as a measure of cardiac diastolic function. The investigators~          hypothesize that classic T2DM markers such as levels of urinary albumin excretion,~          retinopathy, autonomic neuropathy, hypertension, dyslipidemia, elevated HgbA1c, T2DM~          duration, etc. are associated with pathological findings by CMR.~        2. Patients with T2DM have impaired left ventricle myocardial perfusion as determined by~          gadolinium contrast CMR. The investigators hypothesize that the classic markers and risk~          factors mentioned above, are associated with left ventricle myocardial hypoperfusion as~          determined by gadolinium contrast CMR.~   "
67432|NCT02684318|"~     Phase Ib/II study to evaluate the efficacy and tolerability of PM01183 in combination with~     olaparib in patients with advanced solid tumors.~   "
67433|NCT02684305|"~     Induction of labor is one of the most common obstetrical medical procedures performed today.~     Iatrogenic stimulation of uterine contractions prior to the onset of spontaneous labor is~     undertaken for various maternal and fetal indications and spans 20% of deliveries today.~        1. During the past years there has been an additional rise due to elective inductions~        2. Induction is undertaken when potential risks of prolonging pregnancy outweigh the risks~          of induced delivery, particularly those associated with post-term pregnancy, rupture of~          membranes, oligohydramnios and additional fetal and maternal conditions that pose risks~          to mother and fetus.~      In many circumstances of women with an unfavorable cervix (Bishop score of 7 or less)~     sequential induction with more than one agent is necessary. To date, no trial has compared~     the optimal subsequent ripening method after the preliminary use of dinoprostone~     (prostaglandin E2). In this trial investigators aim to compare the obstetrical outcomes of~     subsequent induction in women admitted for induction of labor with Bishop score <7 or less 24~     hours after the insertion of vaginal prostaglandin insert (Propess). Two methods of routine~     induction of labor will be compared: An additional Propess induction for another 24 hours vs.~     intravenous oxytocin infusion combined with intra-cervical balloon insertion.~   "
67434|NCT02684292|"~     The purpose of this study is to evaluate pembrolizumab (MK-3475) in the treatment of~     participants with relapsed or refractory Classical Hodgkin Lymphoma. Participants will be~     randomized to receive either pembrolizumab or brentuximab vedotin (BV) for up to 35~     three-week cycles of treatment.~      The primary hypotheses of this study are that treatment with pembrolizumab prolongs~     Progression-free Survival (PFS) and Overall Survival (OS) in participants with relapsed or~     refractory Classical Hodgkin Lymphoma compared to treatment with BV.~   "
67435|NCT02684279|"~     Binge Eating Disorder Extension Study.~   "
67436|NCT02684266|"~     SHR6390 is a small molecular, oral potent, selective CDK4/6 inhibitor. The purpose of this~     study is to investigate the safety/tolerability and the pharmacokinetic profile of SHR6390 in~     Chinese advanced solid tumor patients by using a 3+3 dose escalation.Preliminary efficacy~     will be also investigated in this study.~   "
67437|NCT02684253|"~     Nivolumab is an antibody (a type of human protein) that is designed to boost your body's~     immune system. It does this by allowing immune cells to grow and fight the cancer. Nivolumab~     has been approved by the FDA for the treatment of melanoma (a form of skin cancer) and lung~     cancer. It is currently under study for the treatment of head and neck squamous cell cancer.~   "
67438|NCT02684240|"~     This research is being done to determine if Nitazoxanide (NTZ) will cause a significant~     decrease in the number of M. tuberculosis bacteria in sputum after 14 days of treatment. The~     study is being conducted at the GHESKIO Centers in Port au Prince Haiti~   "
67439|NCT02684227|"~     This clinical research study has two parts: a safety lead-in and Phase 2.~      The goal of the safety lead-in is to find the highest tolerable dose of enzalutamide in~     combination with carboplatin and paclitaxel that can be given to patients with recurrent or~     advanced endometrial cancer.~      The goal of Phase 2 of this study is to learn if the study drug combination can help to~     control recurrent or advanced endometrial cancer.~      The safety of the drug combination will be studied in both parts of the study.~      This is an investigational study. Enzalutamide is FDA approved for the treatment of certain~     types of prostate cancer. Paclitaxel and carboplatin are FDA approved for the treatment of~     ovarian cancer. The use of the combination of these 3 drugs to treat endometrial cancer is~     investigational.~      Up to 69 participants will be enrolled in this study. All will take part at MD Anderson.~   "
67440|NCT02684214|"~     The ability of Prevention Plus to improve weight status when delivered by primary care~     providers is unknown, and the influence of household food security status as a moderator in~     the treatment of childhood obesity has never been examined. Thus, the investigators will~     conduct a randomized controlled trial (RCT) examining Prevention Plus delivered by CHS~     primary care providers on child zBMI in underserved children receiving their primary care at~     CHS who are overweight and obese, and test the moderating effect of household food security~     status on Prevention Plus delivered with and without caretaker goals~   "
67453|NCT02684032|"~     This is a multicenter, open label, Phase 1b study in patients with mBC. This study will have~     a dose escalation to identify the maximum tolerated dose (MTD) of the combination of~     gedatolisib plus palbociclib/fulvestrant and gedatolisib plus palbociclib/letrozole and~     expansion to estimate the objective response rate (OR) of the combination of gedatolisib plus~     palbociclib/letrozole or palbociclib/fulvestrant.~   "
67472|NCT02683785|"~     This is a randomized, Phase IIa, multicentre, double-blind, placebo-controlled parallel group~     study with the primary objective to assess the efficacy potential of GSK3196165 on pain, in~     subjects with active inflammatory hand osteoarthritis (HOA).~      Approximately 40 subjects will be enrolled into the study, following a screening period of up~     to 4 weeks. The total treatment period will be 12 weeks, with the follow up period completing~     at Week 22. At least 40 subjects will be randomized across the two treatment arms, to either~     placebo or GSK3196165 in a 1:1 ratio.~   "
67441|NCT02684201|"~     Individuals with upper-limb amputation usually have intact nerves within the residual limb,~     and studies have demonstrated that electrical stimulation of those nerves can produce~     sensations that appear to emanate from the amputated limb. In this study, investigators will~     examine the sensations that are produced by electrical stimulation of these nerves at the~     location where they exit the spinal cord. Stimulation of the spinal cord is commonly used to~     treat intractable back and limb pain, and the procedure includes a test phase in which~     electrodes are temporarily placed under the skin near the spinal cord and removed at the end~     of testing. Similarly, in this study, electrodes will be placed near the spinal cord in the~     upper back and neck, and stimulation will be applied over the course of multiple testing~     sessions, lasting less than 30 days. The electrodes will be removed at the last day of~     testing. During each testing session, electrical stimulation will be applied through the~     electrodes and a series of tests will be performed to determine the types of sensations~     produced by stimulation. In addition to producing meaningful sensations with electrical~     stimulation, this study will also test the effect of stimulation on phantom limb sensations~     and phantom limb pain.~   "
67442|NCT02684188|"~     Residents of rural and frontier counties experience significant disparities in health care~     access and outcomes when compared to their urban counterparts. The organization of health~     care delivery contributes significantly to these disparities. For rural residents with~     multiple chronic conditions, transitioning along the continuum of care, between systems of~     treatment and support, and between dispersed locations present significant challenges. One~     critical challenge involves hospitalization for treatment because it requires travel to~     locations at a significant distance from home and disrupts personal and family routines. The~     transition back home is also problematic because discharge planning does not adequately~     account for limited access to care in rural areas. Indeed, discharge planning has been~     recently described as a black hole; fragmented and uncoordinated, and contributing to poor~     outcomes and patient dissatisfaction. The specific aim of this research is to ascertain rural~     patients' actual experience of the discharge planning process and to involve patients and~     rural providers in designing and testing a contextually appropriate rural options discharge~     model (ROADMAP) that improves patient outcomes and reduces re-hospitalizations.~   "
67443|NCT02684175|"~     The objective of this study is to compare remote and in-person audiological cochlear implant~     candidacy evaluations (including audiological (hearing) testing and counseling sessions) in a~     rural Appalachian region.~   "
67444|NCT02684162|"~     The goal of this clinical research study is to learn if giving donor lymphocyte cells and~     SGI-110 will help control acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS)~     (including Chronic Myelomonocytic Leukemia [CMML]) in patients who have had an allogeneic~     stem cell transplant (using someone else's stem cells) and have relapsed (the disease has~     gotten worse). Researchers also want to find out if giving SGI-110 after allogenic stem cell~     transplant in high risk AML and MDS patients would help to improve how long they may remain~     in remission (free of disease) after transplant.~      Researchers also want to learn if SGI-110, when given as maintenance therapy for high-risk~     AML and MDS patients, will reduce the risk of relapse after an allogenic stem cell~     transplantation.~      The safety of this treatment will also be studied.~      This is an investigational study. SGI-110 is not FDA approved or commercially available.~     SGI-110 is made with decitabine, which is FDA approved and commercially available to treat~     MDS. SGI-110 is currently being used for research purposes only. The use of donor lymphocytes~     to treat MDS and AML is FDA approved.~      Up to 90 participants will take part in this study. All will be enrolled at MD Anderson.~   "
67445|NCT02684149|"~     Study objective is to assess the interest of the relational touch before an arterial puncture~     to reduce pain on patient in intensive care unit.~   "
67446|NCT02684136|"~     This study will compare sleep, pain and daytime sleepiness/fatigue in people with insomnia~     co-morbid with fibromyalgia while treated short-term with suvorexant 20 mg versus placebo.~   "
67447|NCT02684123|"~     Alopecia areata is a medical condition, in which the hair falls out in patches. The hair can~     fall out on the scalp or elsewhere on the face and body.~      Alopecia areata is an autoimmune skin disease, which means that the immune system is~     recognizing the hair follicles as foreign and attacking them, causing round patches of hair~     loss. It can progress to total scalp hair loss (alopecia totalis) or complete body hair loss~     (alopecia universalis). The scalp is the most commonly affected area, but the beard or any~     hair-bearing site can be affected alone or together with the scalp. Alopecia areata occurs in~     males and females of all ages, and is a highly unpredictable condition that tends to recur.~     Alopecia areata can cause significant distress to both patients and their families.~      In this study, the aim to assess the effects of a new treatment called apremilast in patients~     with alopecia areata. A total of 30 patients will be included in the study, which will run~     for a total of 52 weeks.~   "
67448|NCT02684097|"~     The purpose of this study is to assess whether tralokinumab can be a helpful treatment for~     alopecia areata. This is a randomized, double-blind, placebo-controlled pilot study of a~     total of 30 subjects with moderate to severe alopecia areata involving 30-100% of the scalp.~     Expected is 50% of these subjects to have concomitant alopecia areata (AA) and atopic~     dermatitis (AD). Subjects with AA alone (15 subjects) will be randomized (2:1) to either~     receive tralokinumab or placebo via subcutaneous injection every 2 weeks for 24 weeks.~     Subjects with concomitant alopecia areata and atopic dermatitis (15 subjects) will be~     randomized separately in a 2:1 ratio to receive tralokinumab or placebo via subcutaneous~     injection every 2 weeks for 24 weeks.~   "
67449|NCT02684084|"~     This is a 24-week, prospective, multi-center, open-label, randomized, investigator-initiated~     pilot study to explore the effects of RBZ (0.5 mg) plus DEX implant (0.7 mg) PRN combination~     therapy (n = 30) vs. DEX implant PRN monotherapy (n = 30) in pseudophakic eyes with~     center-involved DME that have demonstrated prior incomplete response to 3-6 anti-VEGF~     treatments.~   "
67450|NCT02684071|"~     The purpose of this research study is to test an experimental treatment method for recurrent~     or progressive brain tumors in children aged from 0-22 years. The use of methotrexate and~     chemotherapy (topotecan and cyclophosphamide) is experimental in this study. This means that~     their use by themselves or together has not been approved by the U.S. Food and Drug~     Administration for this usage.~   "
67493|NCT02683512|"~     Database for information on individuals affected with glycogen brancher deficiency, also~     known as glycogen storage disease type IV~   "
67454|NCT02684019|"~     Endoscopic retrograde cholangiopancreatography (ERCP) is an invasive longer endoscopic~     procedure. It is performed in remote locations under a continuum of anesthetic depth, ranging~     from conscious to deep sedation leading to general anesthesia.~      Propofol sedation for (ERCP) procedures is the most popular current technique that has~     generated controversy in the medical field. Propofol can be safely administered because of~     its shorter half-life which results in a shorter recovery time than conventional sedation~     (opioid and/or benzodiazepine) that makes it widely used for sedation in many~     gastrointestinal procedures including ERCP. However, because of its narrow therapeutic~     window, the level of conscious sedation can easily go deeper from moderately deep sedation to~     near general anesthesia. Therefore, propofol as a sole agent can cause oversedation and~     apnea. Depth of sedation could be estimated better when target effect concentration of~     propofol is titrated by using bispectral index monitoring device(BIS).Targeting BIS within a~     specific range ensures additional safety during the procedure. Scores between 60-80 have been~     recommended for sedation. Propofol requirement can be reduced with addition of adjuvants (eg.~     Ketamine, Magnesium sulfate and Dexmedetomidine). Most adjuncts have analgesic properties~     with opioid and anesthetic sparing effects, without clinically significant respiratory~     depression.~      Dexmedetomidine, is a selective alpha 2 agonist; it has sedative, amnestic, and analgesic~     properties. It is a useful addition to a propofol/remifentanil anesthetic combination as it~     reduced their requirements intraoperatively and can help supplement analgesia~     postoperatively. Its combination with propofol was proved to provide satisfactory anesthesia~     for upper gastrointestinal (GI)) endoscopy in obstructive sleep apnea patients .~      Magnesium can also act as an adjuvant in analgesia due to its properties as calcium channel~     blocker and N-methyl-D-aspartate antagonists .It was suggested to be a near ideal intravenous~     (IV) adjunct to propofol/ remifentanil based total anesthesia in gynaecology patients .~      Hypothesis of this study is that Magnesium sulfate can have a propofol sparing effect during~     ERCP procedures guided by BIS monitoring as efficient as dexmedetomidine but with less cost~     and complications together with more patient and doctor satisfaction in addition to better~     patient outcome.~   "
67455|NCT02684006|"~     This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of avelumab~     in combination with axitinib and of sunitinib monotherapy, administered as first-line~     treatment, in patients with advanced renal cell carcinoma~   "
67456|NCT02683993|"~     Twenty (20) subjects presenting with a renal stone and candidates for FURS (flexible~     ureteroscopic renal surgery) will undergo a single FURS procedure for a kidney stone as part~     of the study, using the study device. These subjects will be randomized into stone breaking~     treatment or stone dusting.~   "
67457|NCT02683980|"~     Twenty (20) subjects presenting with a hyperplasia enlarged prostate and candidates for~     surgery will undergo a single treatment for ablation of the prostate using the study~     device.Follow up visits are scheduled for the day of release from the hospital and at 1 and 3~     months post procedure.~      The primary objective of this study is to explore Vaporization efficacy and safety when~     treating PBH (Benign prostatic hyperplasia ) with the contact side firing fiber with~     recommended settings.~   "
67458|NCT02683967|"~     The trial aims to investigate whether acupuncture has an effect in increasing clinical~     pregnancy (pregnancy that is confirmed by a scan) and live birth rates on women undergoing~     IVF treatment.~   "
67459|NCT02683954|"~     The association between endometriosis, obesity and nesfatin1.~   "
67460|NCT02683941|"~     This is a Phase 3, prospective, multi-center, randomized, double-blind, study evaluating the~     efficacy and safety of LAN plus BSC versus placebo plus BSC for the treatment of~     well-differentiated, metastatic and/or unresectable, typical or atypical lung NETs This study~     contains two phases: the Double-Blind (DB) Phase, and the Open Label (OL) Extension Phase.~     The DB Phase includes: Screening, Baseline and Treatment period. The OL Extension Phase will~     consist of two periods: Treatment Period and Follow-Up Period.~      The primary objective will be to compare the antitumour efficacy of Lanreotide Autogel/Depot~     120 mg (LAN) plus Best Supportive Care (BSC) every 28 days versus placebo plus BSC, in terms~     of progression free survival (PFS), measured by central review using Response Evaluation~     Criteria in Solid Tumours (RECIST) v1.1 criteria, every 12 weeks, in subjects with~     unresectable and/or metastatic well differentiated, typical or atypical lung neuroendocrine~     tumours~   "
67461|NCT02683928|"~     The purpose of this study is to determine the effect of GBR 830 on biomarkers in AD/ eczema~     to enable further studies in this indication.~   "
67462|NCT02683915|"~     This study aims to determine the effect of therapeutic hypothermia on reducing AKI in term~     and late-preterm infants with hypoxic ischemic encephalopathy as estimated by measurment of~     serum(s) neutrophil gelatinase-associated lipocalin(NGAL) and serum (s) cystatin-C.~   "
67463|NCT02683902|"~     To compare four weeks of transcranial direct current stimulation (tDCS) versus placebo~     associated with a reduced caloric diet on weight loss, glycemic control and regulators of~     hunger and satiety in overweight or obese subjects with different degrees of glucose~     tolerance, submitted to hypocaloric diet.~   "
67464|NCT02683889|"~     This study will evaluate the use of Acthar in patients to undergo renal transplantation and~     will measure the rate of FSGS recurrence.~   "
67465|NCT02683876|"~     The purpose of this study is to identify metabolic signatures associated with malodor~     conditions. The investigators will perform state-of-the art metabolomics tests and~     bioinformatic data mining to explore if conditions leading to malodor can be screened by~     metabolomic profiling of urine samples.~   "
67466|NCT02683863|"~     The purpose of this study is to explore whether DMF (Dimethyl Fumarate) or MMF (monomethyl~     fumarate) its main bioactive metabolite, is capable of entering the central nervous system in~     SPMS patients that are being treated with Tecfidera®. PK samples (pharmacokinetics - or the~     amount of study drug in blood) will be tested to compare with PK samples, the amount of study~     drug, in spinal fluid (CSF).~   "
67467|NCT02683850|"~     This prospective, non-randomized, open-label study will assess if taking an Omega-3 SPM™ soft~     gel supplement for four weeks will increase the quality of life in adults with chronic pain.~   "
67468|NCT02683837|"~     The aim of this prospective randomized study is to evaluate the impact of peroperative~     pupillometry monitoring on per and post-operative opioid consumption in pediatric anesthesia.~     All patients are anesthetized with sevoflurane and remifentanil. In the intervention group,~     peroperative remifentanil infusion rate is guided by pupillometry. In the other group,~     remifentanil infusion rate is guided according to hemodynamic data.~   "
67469|NCT02683824|"~     This pilot clinical trial studies the use of integrin alpha-v-beta [18F]-R01-MG-F2 Positron~     Emission Tomography/Computed Tomography (PET/CT) and Positron Emission Tomography-Magnetic~     Resonance Imaging in (PET/MRI) in measuring response in patients with pancreatic cancer and~     healthy volunteers. Integrins, such as integrin alpha-v-beta-6 (avb6), are a family of~     membrane receptors that are overexpressed on the cell surface of pancreatic cancers.~     [18F]-R01-MG-F2 targets avb6, which may improve early detection of and better stratify~     treatment options for patients with pancreatic cancer.~   "
67473|NCT02683772|"~     Patients with chronic respiratory failure such as those associated with Chronic Obstructive~     Pulmonary Disease (COPD), Obesity Hypoventilation Syndrome (OHS), Obstructive Sleep Apnea~     (OSA) or Neuromuscular Disease (NMD) are increasingly managed with domiciliary non-invasive~     positive pressure ventilation (NIPPV). The aim of this study is to now compare the Automatic~     Expiratory Positive Airway Pressure (AutoEPAP) algorithm with a fixed manual EPAP in iVAPS~     mode on an Astral mixed mode ventilator. It is proposed that the automatic settings of~     AutoEPAP will be as effective at managing respiratory failure and upper airway obstruction~     (UAO) as manual EPAP on the Astral device. Specifically demonstrating that the AutoEPAP~     function is as effective at treating UAO as manual EPAP.~   "
67474|NCT02683759|"~     Inflammatory Bowel Disease, including ulcerative colitis, is thought to result from an~     imbalance of pro-inflammatory and anti-inflammatory factors. As such, the majority of~     treatment options are directed at attempting to control the chronic inflammation and~     prolonging remission of clinical symptoms. Several studies have proven that curcumin has~     well-established anti-inflammatory properties. However, curcumin has poor bioavailability and~     prior studies have needed to use high concentrations in order to study the efficacy of the~     product. The investigators propose that a bio-enhanced preparation of curcumin will require a~     lower dosage to reach and affect its target tissue and will subsequently produce less adverse~     side effects.~   "
67475|NCT02683746|"~     This is a phase III, randomized, double-blind, multicenter, parallel group, repeat-dose,~     study of 26 weeks duration to evaluate the efficacy, safety, tolerability and pharmacodynamic~     response of albiglutide liquid drug product relative to the commercial lyophilized drug~     product. The study will specifically evaluate the potential for immunogenicity (example~     [e.g.] incidences of anti-drug antibodies [ADA]) and injection site reactions (ISRs).~      Albiglutide is a novel analogue of glucagon-like peptide-1 (GLP-1) with a sufficiently long~     half-life to permit once a week injection. Currently, lyophilized albiglutide and the diluent~     are provided in a dual chamber cartridge (DCC), single-dose pen injector, requiring~     reconstitution prior to use. A liquid formulation of albiglutide will enable the~     commercialization of a liquid product in a single dose, ready-to-use prefilled syringe in an~     auto-injector.~      The primary hypothesis of this study is to test that liquid drug product will provide~     glycemic control (as measured by HbA1c change from baseline) non-inferior to lyophilized drug~     product for a period of 26 weeks of treatment in subjects with T2DM.~      This study will comprise of 3 study periods : screening (2 weeks), treatment (26 weeks) and~     for those subjects not entering the extension study a follow-up period (8 weeks).~     Approximately 300 subjects will be randomized in a 1:1 ratio to either Albiglutide active~     liquid auto-injector (LAI) plus Placebo lyophilized DCC pen injector (lyophilized DCC PI);~     or, Albiglutide lyophilized DCC PI plus Placebo LAI.~   "
67476|NCT02683733|"~     Inflammatory Bowel Disease, including ulcerative colitis, is thought to result from an~     imbalance of pro-inflammatory and anti-inflammatory factors. As such, the majority of~     treatment options are directed at attempting to control the chronic inflammation and~     prolonging remission of clinical symptoms. Several studies have proven that curcumin has~     well-established anti-inflammatory properties. However, curcumin has poor bioavailability and~     prior studies have needed to use high concentrations in order to study the efficacy of the~     product. The investigators propose that a bio-enhanced preparation of curcumin will require a~     lower dosage to reach and affect its target tissue and will subsequently produce less adverse~     side effects.~   "
67477|NCT02683720|"~     ProMO aims to investigate the effectiveness of a newly developed ONS in increasing body~     weight, muscle mass and function in malnourished elderly compared to standard care.~   "
67478|NCT02683707|"~     With potent analgesic properties, perceived hemodynamic benefits and limited alternatives,~     opiates are the analgesic mainstay for acute coronary syndrome (ACS) patients reporting~     peri-procedural pain or nitrate-resistant chest pain. However, large observational studies~     suggest that opiate administration during ACS may result in adverse cardiovascular outcomes.~     Complimenting this, a number of recent mechanistic studies have demonstrated delayed and~     attenuated effects of oral dual anti-platelet therapy (DAPT) on platelet inhibition endpoints~     among subjects receiving intravenous morphine. These studies support the hypothesis that~     morphine delays the gastrointestinal absorption of DAPT medications. However, no data exist~     on the impact of intravenous fentanyl, a systemic opioid analgesic routinely administered~     during percutaneous coronary intervention (PCI) procedures, on the platelet inhibition~     effects of DAPT. The investigators hypothesize that, similar to morphine, fentanyl~     administered at the time of PCI will reduce and delay the effect of DAPT on platelet~     function. As such, the primary aim of this study is to test the impact of intravenous~     fentanyl on residual platelet reactivity by randomizing patients undergoing PCI to a strategy~     of peri-procedural benzodiazepine plus non-systemic local analgesia or to the current~     standard of benzodiazepine plus intravenous fentanyl. Given the critical need for rapid and~     robust inhibition of platelet function during PCI, this trial has true potential to change~     clinical practice, particularly if the investigators demonstrate reduced DAPT absorption and~     elevated residual platelet reactivity among patients receiving fentanyl during PCI.~   "
67479|NCT02683694|"~     During the last decade optical coherence tomography (OCT) extended the possibilities for in~     vivo macula diagnostic and was increasingly used for pre- and post-operative imaging of~     retinal diseases. Spectral-domain optical coherence tomography (SD-OCT) with its increased~     scanning speed and image-resolution provides more detailed information of microstructures in~     the macula.~      Epiretinal membrane (ERM), lamellar macular hole, macular hole and vitreomacular traction~     syndrome are disorders involving the posterior pole of the eyeball with consecutive vision~     loss. In patients with loss of vision and metamorphopsia disturbing their lifestyle,~     vitrectomy and membrane peeling is usually performed to remove traction and the ERM.~      Different study groups showed that intraoperative use of SD-OCT is possible and improves the~     quality of peeling surgery.~   "
67480|NCT02683681|"~     This is a registry study. This is an observational, non-randomized, open, long-term project~     to collect biological samples (e.g. tissue and blood samples) in addition to clinical~     information and laboratory test results, from end-stage patients who undergo LVAD~     implantation and/or heart transplantation. There are no investigational treatments, drug or~     procedures associated with participation in registry activities.~      Data collection will not immediately influence the course of treatment for any patient.~   "
67481|NCT02683668|"~     The aim of the study is to investigate the effect of tiotropium from different devices on a~     panel of small (IOS, MBNW, DLCO, FVC) and large airway (FEV1, PEF) responses in patients with~     mild-moderate COPD. Comparisons will be made between Tiotropium Handihaler 18 micrograms once~     daily and Tiotropium Respimat 5 micrograms once daily~   "
67482|NCT02683655|"~     The purpose of this study is to assess the efficacy and safety of apatinib in Metastatic~     Esophageal Cancer.~   "
67483|NCT02683642|"~     Invasive mould infections are emerging causes of morbidity and mortality in ICU patients.~     This is attributed to prolonged ICU stay of critically ill patients with many co-morbidities.~     Modern medicine and multiple intervention make the patients susceptible to these prevalent~     moulds in the environment. In India the high frequency of IMIs in general has been attributed~     to environmental and host factors prevalent in this region. Additionally sub-optimal hospital~     care practice, frequent demolition and construction activities in the hospital make the~     patients susceptible to IMIs. There is no multicentric study available in India describing~     the epidemiology of IMIs in India. However, single center studies have reported distinct~     epidemiology of IMIs in India. High incidence, different spectrum and risk factors are~     possible unique features of IMIs in India.Early diagnosis and optimal therapy improve the~     outcome of these patients. The conventional diagnosis including histopathology and culture~     has limitations. The tests are of low sensitivity and long turnaround time. The major~     challenge is collection of sample from deep tissue. Therefore majority of the patients in~     ICUs of India are managed empirically against invasive fungal diseases. The galactomannan~     test has improved the diagnosis of invasive aspergillosis. However, galactomannan test is not~     well standardized in non-neutropenic patients. Beta-glucan test is used for early diagnosis~     of invasive fungal infections other than mucormycosis. But the test is cumbersome for routine~     laboratories and expensive. Both tests are not available in majority of Institutions of~     India. PCR assay is not standardized and not performed routinely in any Institution.~      Due these limitations in diagnosis, there is no uniform management protocol in ICUs of India.~     To develop optimal management protocol, we need to know the epidemiology, the right patient~     to treat, antifungal drug resistance, optimal drug and duration of therapy etc. The present~     study will provide descriptive epidemiology, present status of diagnosis and management~     practiced in India to treat IMIs in ICUs. This will help to find the suitable intervention~     strategies to improve outcome of IMIs in India.This descriptive observational prospective~     study will document the epidemiologic and clinical characteristics, as well as treatment and~     outcome data, of patients with IMIs in ICUs in India over one year.~   "
67484|NCT02683629|"~     To assess the safety of xenotransplantation of NTCELL [immunoprotected~     (alginate-encapsulated) choroid plexus cells] in patients with Parkinson's disease, assessed~     over the duration of the study, by monitoring the occurrence of adverse events and serious~     adverse events, including clinical and laboratory evidence of xenogeneic infection in~     transplant recipients and their partners/close contacts. Subsequent safety follow-up will~     include lifelong monitoring for clinical and laboratory evidence of xenogeneic infection.~      To assess the efficacy of xenotransplantation of NTCELL [immunoprotected~     (alginate-encapsulated) choroid plexus cells] in patients with Parkinson's disease. This will~     be quantified by testing the secondary endpoints of the trial as described below (see~     Endpoints/Outcome Measures).~   "
67485|NCT02683616|"~     Obstructive sleep apnea syndrome (OSA) is a disease affecting 5-15% of population and 50-80%~     of type 2 diabetes mellitus (T2DM) and obese subjects. OSA causally contributes to the~     development of glucose intolerance and T2DM. The project is targeting the gap in providing~     effective treatment of metabolic impairments associated with OSA, particularly T2DM. In~     contrast to proved benefits of OSA treatment with CPAP (continuous positive airway pressure)~     on cardiovascular morbidity/mortality, studies on the impact of CPAP on diabetes control are~     disappointing. In fact, OSA-induced metabolic impairments might not be reversible with CPAP~     treatment, as investigators suggested recently. Clearly, the search for additional~     treatments, probably pharmacological, is warranted. Investigators hypothesize that elevated~     levels of free fatty acids (FFA), as detected in OSA patients, are linking OSA with the T2DM~     development. The aim of the study is to target adipose tissue and muscle dysfunction leading~     to elevated FFA and develop thus novel pharmacological treatments based on lipolysis~     inhibition and stimulation of FFA oxidation.~   "
67486|NCT02683603|"~     the management of Ventilator-associated pneumonia (VAP) caused by multidrug-resistant (MDR)~     gram-negative bacilli (GNB) represent a real therapeutic dilemma in intensive care unit~     (ICU). Colistin remains an effective agent against MDR GNB. However, because of its side~     effects, mainly nephrotoxicity, other modalities than the intra venous (IV) route should be~     tried. Several recent data emphasize the interest of inhaled route. The investigators purpose~     was to evaluate the effectiveness and systemic toxicity of aerosolized colistin in ventilator~     associated pneumonia.~   "
67487|NCT02683590|"~     For the replacement of the sternum, there is no consensus regarding the most appropriate and~     most effective physiologically material. The use of ceramic implant offers significant~     operational time saving and biocompatibility coupled with the strength of the material allow~     us to realize a more natural operation, limiting the risk of infection and rejection.~      Main objective: to evaluate the efficiency of the replacement of the sternum by a ceramic~     implant on the respiratory capacity at 3 months post surgery.~   "
67488|NCT02683577|"~     The purpose of the protocol is to assess the pharmacokinetics, safety and tolerability of a~     single dose of telotristat etiprate in subjects with various stages of hepatic impairment~     compared to healthy control subjects.~   "
67489|NCT02683564|"~     This is a prospective, randomized, double-blind, parallel group, multicentre global phase 3~     clinical study to evaluate the efficacy, safety and immunogenicity of BOW015~     (infliximab-EPIRUS) compared to Remicade in subjects with active Rheumatoid Arthritis (RA)~     despite Methotrexate (MTX) therapy.~   "
67490|NCT02683551|"~     Patients underwent thyroidectomy filled an computer or paper based QoL questionnaire before~     and after operation.~   "
67491|NCT02683538|"~     The purpose of this study is to evaluate the clinical feasibility and short-term outcome of~     switching monopolar RFA using a separable cluster electrode in patients with primary and~     secondary liver malignancies.~   "
67492|NCT02683525|"~     Primary Objective~      Evaluate the efficacy of sitagliptin in reducing the incidence of grade II-IV acute Graft~     Versus-Host Disease (GvHD) by day +100 post-transplant in patients undergoing allogeneic~     hematopoietic stem cell transplantation and receiving standard sirolimus and tacrolimus GvHD~     prophylaxis.~      Secondary Objectives~      The following descriptive secondary objectives will be studied:~        1. Describe the tolerability and potential toxicity of sitagliptin.~        2. Describe the cumulative incidence of grades II-IV acute GvHD by day +100.~        3. Describe the cumulative incidence of grades III-IV acute GvHD.~        4. Describe the engraftment kinetics of absolute neutrophil count and platelets.~        5. Describe the incidence of infections occurring during the 100 days post-transplant.~        6. Describe non-relapse mortality (NRM) at day +30, +100, and 1 year post-transplant.~        7. Describe overall survival.~        8. Describe the incidence of chronic GvHD.~        9. Describe the cumulative incidence of relapse of the primary hematological malignancy.~   "
67494|NCT02683499|"~     The aim of the study is to assess the marginal fit following preparation finishing with~     ultrasonic tips of porcelain veneers compared to the ordinary preparation using burs only.~     Two-hundred and forty crowns prepared to receive porcelain veneers (in a split-mouth design).~     On one side of the mouth, the prepared surfaces will be finished with ultrasonic tips.~     Marginal fit is measured by a 'cement replica technique'.~   "
67495|NCT02683486|"~     The aim of this study is to assess whether an auto-titrating oxygen system can maintain~     constant oxygen saturations (SpO2) in patients who are on long-term oxygen therapy (LTOT)~     during activities of daily living.~      Currently LTOT is provided at a constant fixed-flow rate e.g. 2 litres per minute all the~     time after appropriate assessment. The flow rate is not changed during usual household~     activities but is increased for walking. A number of studies have investigated the SpO2 of~     patients on LTOT during the daytime in patients' homes. The results have shown that patients'~     SpO2 decreases intermittently whilst they are doing activities of daily living such as~     watching television, putting away the shopping, having a shower or bath and dressing and~     undressing. This is a problem as it can lead to breathlessness, increased stress on the heart~     and affect brain function. In order to correct the drop in SpO2 that patients experience~     during everyday activities, the investigators have developed an oxygen system, which can~     automatically change the amount of oxygen delivered depending on a patients' oxygen~     saturations - an auto-titrating oxygen system. In this study, patients on LTOT will be asked~     to simulate a series of activities of daily living twice: once whilst on their usual~     fixed-flow oxygen therapy and once on the auto-titrating oxygen system. The activities will~     be carried out in a hospital setting. During the activities, SpO2 will be recorded~     continuously. The main outcome of interest from the study will be the SpO2 throughout the~     study on fixed-flow oxygen and the auto-titrating oxygen system.~   "
67496|NCT02683473|"~     The purpose of this study is to measure energy expenditure during the first 3 months of life~     in infants.~   "
67497|NCT02683460|"~     This study aims to compare the clinical results of patella resurfacing or not under subvastus~     approach in total knee arthroplasty. Even though the excellent results of total knee~     arthroplasty(TKA), there is persistent controversy over whether or not to replace the~     patella. Anterior knee pain continued to be a unsolved problem of TKA patients. Some surgeons~     always performed patella resurfacing during total knee arthroplasty but the others didn't do~     that. It's up to surgeon's preference. There were several studies of patellar resurfacing or~     not in TKA. But previous studies almost have been done under other approach, not a subvastus~     approach.~      This study prospectively randomized patients receiving bilateral TKA with patellar~     resurfacing or not in each knee. Patients preference and clinical results was investigated in~     both knee of same patients who received patellar resurfacing or not during minimum 2 year~     follow up.~   "
67498|NCT02683447|"~     The proportion of older acute care physicians (ACPs) has been increasing. Ageing is~     associated with physiological changes and research investigating how such age-related~     physiological changes affect clinical performance is lacking. Specifically, Crisis Resource~     Management (CRM) consists of essential clinical skills in acute care specialties which when~     absent, can significantly impact patient safety. As such, the goals of this study are to~     investigate whether ageing has a correlation with baseline CRM skills of ACPs and whether~     ageing influences learning from high fidelity simulation.~   "
67499|NCT02683434|"~     The purpose of our study is to investigate the effects of Kinesio Taping application, which~     is applied before the training period, on postural stability in young soccer players.~   "
67500|NCT02683421|"~     Determine the localization of Tc 99m tilmanocept by SPECT and SPECT/CT imaging in subjects~     with active RA and concordance with clinical symptomology.~   "
67501|NCT02683408|"~     Diosmiplex is a product marketed for the management of diseases due to venous and~     microvascular dysfunction. Raynaud's phenomenon is a disorder of characterized by spasm of~     small arteries and impaired microvascular flow. This study will examine the effects of~     diosmiplex on the frequency and severity of Raynaud's episodes in susceptible people.~   "
67502|NCT02683395|"~     The purpose of this research study is to evaluate safety, pharmacokinetics, pharmacodynamics,~     and preliminary efficacy of the investigational drug PLX51107 in subjects with advanced solid~     tumors (including lymphoma), acute myeloid leukemia (AML), or high-risk myelodysplastic~     syndrome (MDS).~   "
67503|NCT02683382|"~     Dry eye is a common syndrome associated with symptoms of dryness, burning, itching and~     grittiness of eyes. The objective of this study is to investigate the effects of a~     moisturizing product in liquid formula on symptoms and signs of dry eye and on skin around~     the eyes.~   "
67504|NCT02683369|"~     Healthy premenopausal women that are iron-deficient without anemia will receive a low-dose~     iron dietary supplement. The investigators seek to determine if the low-dose iron dietary~     supplement will restore iron levels to normal range with fewer side effects than typically~     experienced at higher doses of iron supplementation.~   "
67505|NCT02683356|"~     Fully Bioresorbable Vascular Scaffolds (BVS) have been introduced with the objective to~     preserve native vessel geometry, allow for adaptive vessel remodeling with late lumen gain,~     restore physiological vasomotion, and avoid late adverse events including restenosis and~     scaffold thrombosis. Although randomized clinical trials in low risk patients to date suggest~     non-inferiority in terms of safety and efficacy compared with metallic DES, several reports~     have raised concerns regarding the scaffold thrombosis highlighting the importance of~     technical considerations regarding lesion preparation and scaffold expansion. OCT offers the~     opportunity to plan the procedure and optimize the implantation of BVS.~      The hypothesis of the present study is that a strategy of OCT-guided PCI using BVS is~     superior to angiography-guided PCI (e.g. by selecting scaffold dimension on the basis of a~     pre-procedural OCT and applying corrective measures in case of suboptimal treatment result as~     indicated by OCT).~   "
67528|NCT02683057|"~     Our study addresses a previously selected population or by physical activity but not for~     semen quality semen donor candidates donation program within the clinic.~      Total physical activity was analyzed according to the universally accepted international~     physical activity questionnaire (IPAQ) The existence of confounding factors associated She~     purge age, snuff, weight, BMI, alcohol, drugs, type of sport and associated blood parameters~     determinations will be made to exercise.~   "
67506|NCT02683343|"~     Carpal tunnel syndrome (CTS) is a common condition that still lacks a reliable, objective~     screening test. Many anatomical aspects of the syndrome have been studied including the~     dimensions of the carpal tunnel and shape of the nerve within the tunnel. The investigators~     have observed varying amounts of muscle overlying the carpal tunnel in patients undergoing~     surgery for the condition. Assuming that this muscle may have a dynamic role in the~     development of the condition, the investigators attempted to quantify this muscle using~     ultrasound (US).~      The purpose of this study was to devise a technique to evaluate the amount of muscle~     overlying the carpal tunnel.~      The hypothesis is that patients with carpal tunnel syndrome will have significantly more~     muscle overlying the carpal tunnel than individuals without carpal tunnel syndrome.~   "
67507|NCT02683330|"~     Psychological difficulties, especially depression and anxiety are the most prevalent~     non-motor symptoms in Parkinson's Disease (PD). Pharmacological treatments are not as~     effective in PD. Mindfulness courses have received increased popularity and recognition as an~     effective way to manage emotional states, and there is ever growing findings of the~     effectiveness of mindfulness courses for people with long-term medical conditions. Two small~     pilot studies have indicated that mindfulness courses can be helpful for people with PD in~     improving symptoms of depression, language functioning and motor symptoms. The investigators~     propose to deliver these courses remotely, through Skype video conferences, to make it more~     accessible for people with mobility limitations and people who live in rural areas.~   "
67508|NCT02683317|"~     The purpose of this study is to evaluate whether docosahexaenoic acid given by enteral~     feeding prevent retinopathy of prematurity and/or diminish its severity in preterm infants.~   "
67509|NCT02683304|"~     The main objective of this pilot study is to make a first assessment of the discriminating~     ability of a dosage of S100B protein for differential diagnosis between primary headaches and~     secondary headaches.~      For this, the investigators will compare serum S100B protein between two groups of headache~     patients presenting at the emergency department: 1 group of primary headache patients and 1~     group of secondary headache patients.~      If the difference between the two groups proves potentially discriminating, the investigators~     will seek to determine the discriminating ability of the S100B protein by calculating the~     area under the ROC curve.~      The reference diagnostic will be set at one month across the entire clinical picture and~     imaging by an expert committee composed of a neurologist, a radiologist and an emergency~     physician.~   "
67510|NCT02683291|"~     There is no consensus on the best immunosuppressive regimen in elderly people. The aim of~     this study will be to evaluate the efficacy of sirolimus associated with tacrolimus in~     elderly kidney transplant recipients. The investigators will conduct a single-center~     prospective randomized study comparing the combination of tacrolimus with sirolimus at~     reduced dose rate (tacrolimus + sirolimus group) against tacrolimus with mycophenolate~     (tacrolimus + mycophenolate group). The investigators will include all kidney transplant~     patients over 60 years of age. The investigators will evaluate estimated glomerular~     filtration rate and incidence of cytomegalovirus in 12 month follow-up.~   "
67511|NCT02683278|"~     This study compares the impact of cognitive-behavioral therapy for pain (CBT-P), mindful~     awareness and acceptance treatment (M), and arthritis education as an active control~     condition (E) on mental and physical health outcomes among adults with chronic pain due to~     fibromyalgia (FM).~   "
67512|NCT02683265|"~     This randomized, double-blind, flexible-dose, placebo-controlled, parallel group study is~     designed to evaluate Aptensio XR® compared to placebo in preschool age children with ADHD.~     Male and female children ages 4 years, 0 months to 5 years, 8 months with a diagnosis of ADHD~     (combined, inattentive or hyperactive/impulsive) will be enrolled.~      There will be 6 phases in this study: a screening phase of up to 4 weeks, which will include~     washout if applicable, an enrollment & parent training phase lasting 2-4 weeks, an~     eligibility phase of up to 2 weeks to determine eligibility for the open-label phase, a~     6-week open-label dose titration phase, a 2 week double-blind phase for Aptensio XR®~     responders, and a two-week follow-up call after study completion or early discontinuation to~     assess for ongoing adverse events and concomitant medications.~      Up to 150 subjects will be enrolled in this trial to allow for subjects who improve~     significantly during the behavior training phase and drop-outs. Once 74 subjects have~     completed the double-blind phase, no additional subjects will be enrolled in the trial.~     Subjects who are already enrolled at that time will be allowed to complete the trial.~      The primary objective of this study is to establish that an optimal dose of Aptensio XR® will~     result in a significant reduction in ADHD symptoms compared with placebo in children ages 4~     to under 6 years~   "
67513|NCT02683252|"~     Study on quantitative perfusion parameters acquired on MR imaging of patients with~     non-tumoral pathology of the musculoskeletal system.~   "
67514|NCT02683239|"~     This study of up to 7,000 participants will further characterize the safety profile of~     fasinumab.~      A subset of approximately 1,000 participants at select sites will also participate in a~     sub-study to characterize the efficacy of fasinumab.~   "
67515|NCT02683226|"~     The purpose of this study was to determine whether dual treatment with metformin and~     alogliptin is more effective than treatment with metformin, alogliptin and pioglitazone in~     the treatment of obese women with polycystic ovary syndrome (PCOS) regarding insulin~     resistance and beta cell function.~   "
67516|NCT02683213|"~     The purpose of this study is to investigate whether routine administration of fluoxetine 20mg~     once daily in the 6 months initiated during the acute stroke improves the patient's~     functional outcome.~      EFFECTS is an investigator lead Sweden-based, multicenter, parallel group, double blind~     placebo controlled trial with broad entry criteria and follow up at 6 and 12 months.~      The anticipated numbers of participants is 1,500 in Sweden. As of 31 August 2017, EFFECTS has~     recruited 810 participants at 35 centers. Last patient in is anticipated July 2019, with the~     last follow-up one year later.~   "
67517|NCT02683200|"~     This pilot clinical trial studies magnetic resonance imaging (MRI)-guided stereotactic body~     radiation therapy (SBRT) in treating patients with liver metastases or liver cancer. SBRT is~     a specialized radiation therapy that delivers a single, high dose of radiation directly to~     the tumor and may kill more tumor cells and cause less damage to normal tissue. Combining MRI~     with SBRT may help doctors to highlight the tissues surrounding the tumor better.~   "
67518|NCT02683187|"~     This study is being done to determine the role of a hormone, glucagon-like peptide 1 (GLP-1),~     on insulin secretion and to study how GLP-1 works in in diabetic individuals as compared to~     non-diabetic individuals, under fasting conditions.~      GLP-1 is a naturally occurring hormone made in the intestines. It is released into the~     circulating blood after eating and helps to control the blood glucose levels by increasing~     insulin secretion by cells in the pancreas. However, the exact method by which GLP-1 causes~     insulin secretion and how GLP-1 activity is changed in diabetic persons remain unclear. This~     research is being done to address these questions and better understand the function of~     GLP-1.~      In this research, the investigators will use a synthetic form of Exendin-9 to determine the~     effects of GLP-1 on insulin secretion in diabetic and non-diabetic persons. Exendin-9 acts as~     a blocker of GLP-1 action, allowing us to study the specific effects of the GLP-1 hormone.~     Exendin-9 is an investigational compound, which means it is still being tested in research~     studies and is not approved by the U.S. Food and Drug Administration (FDA).~      In this study, the investigators will also use the drug Sitagliptin, which is an FDA-approved~     drug for the treatment of type 2 diabetes mellitus. In this study, use of Sitagliptin is~     considered investigational since it is not being used for treatment of diabetes but is~     instead being used to understand how GLP-1 works and to better understand how medications~     like Sitagliptin work in patients with type 2 diabetes mellitus.~   "
67519|NCT02683174|"~     Syncope is a common Emergency Department (ED) presentation but the underlying diagnosis is~     not apparent in 60% of patients after assessment and serious adverse event rate is 7% at one~     month with most having acute cardiovascular events, also more likely to be unexplained after~     ED assessment. Many cardiovascular events are due to arrhythmia, difficult for clinicians to~     diagnose, as examination and Electrocardiogram (ECG) findings may both be normal and symptoms~     have resolved by the time the patient gets to the ED. Currently establishing a cardiac~     arrhythmia as the cause of syncope rests on correlating the arrhythmia with symptoms using~     monitoring devices such as Holter but these all have significant drawbacks. The clinical~     challenge in the ED is therefore to identify the moderate and high-risk patients and refer~     them for further investigation and monitoring if appropriate. The logistics of arranging~     follow up within a timely period of the patient's ED visit is often problematic for a variety~     of reasons including availability of timely specialty outpatient appointments, a lack of~     consensus of the specialty to whom the syncope patient should be referred (cardiology,~     medicine, neurology, general practice) and availability of Holter and other monitoring~     devices. For this reason most high and medium risk patients are admitted to hospital.~      Previous syncope clinical decision rules have not been well adopted due to their lack of~     sensitivity and specificity probably due to the varied and heterogeneous nature of~     potentially serious causes. However, the majority of patients with syncope have no serious~     underlying pathology and do not require hospitalisation. Rather than continued attempts at~     risk stratification of outcome based on presentation, more research is required into how we~     can better improve diagnosis and therefore treatment in order to provide improved patient~     benefit. We believe that ambulatory patch monitoring will allow better and earlier arrhythmia~     detection and plan to assess the ability of a 14-day ambulatory patch to detect serious~     arrhythmic outcomes at 90 days.~   "
67520|NCT02683161|"~     The study will evaluate the feasibility of integrating an intensive pre- post-surgical~     smoking cessation intervention into a hospital setting, and assess measures of postsurgical~     recovery as a function of smoking cessation status.~   "
67521|NCT02683148|"~     DHEA is a natural allosteric inhibitor of glucose-6-phosphate dehydrogenase (G6PD). G6PD is a~     key regulatory enzyme for the survival of synovial sarcoma. The investigators postulate that~     they can inhibit the production of NADPH in synovial sarcoma and cause cell death by using a~     naturally occurring G6PD inhibitor.~   "
67522|NCT02683135|"~     Large spikes in blood glucose experienced after meals in people with type 2 diabetes are~     known to damage blood vessels. Low carbohydrate high fat diets and exercise can improve blood~     glucose control in people with type 2 diabetes but it is unclear how these two strategies~     interact to affect blood vessel function and inflammation. We will examine how following a~     short-term low carbohydrate high fat diet (4 days) with or without post-meal walking impacts~     markers of blood vessel function and inflammation. We will also examine how a single low~     carbohydrate high fat meal, with or without post-meal walking, impacts blood glucose control~     and blood vessel function. Findings will help determine the best lifestyle approach for~     improving cardiovascular health in type 2 diabetes.~   "
67523|NCT02683122|"~     The place of analysis of organ dysfunction in relation to the diagnosis of nosocomial~     pneumonia in intensive care is not yet defined.~   "
67524|NCT02683109|"~     This is a 4-week, multicenter, randomized, double-blind, parallel group and active controlled~     study.~      Patients will be randomized (1 to 1 ratio) to a 4-week double-blind treatment period of~     either FDC of tiotropium + olodaterol (5/5 µg) plus placebo or the free combination of~     tiotropium 5 µg and olodaterol 5 µg; all administered via the Respimat® inhaler. The purpose~     is to show non-inferiority between the FDC and the free combination of tiotropium and~     olodaterol in patients with COPD.~   "
67525|NCT02683096|"~     Our central hypothesis is that screening newborn infants who either fail their newborn~     hearing test or have a diagnosis of small for gestational age (SGA) will lead to better~     identification of infants with congenital CMV infection and enhanced rates of therapeutic~     intervention. This has the potential to significantly improve outcomes for infants with this~     common viral infection. This particular cohort of patients have not been well studied locally~     or regionally. In addition, in view of current legislation that will be effective in January,~     2016 this is a timely project that will provide preliminary data for future statewide~     recommendations around CMV testing of newborn infants. This will be a pilot/feasibility study~     to obtain preliminary data for an Illinois Department of Public Health (IDPH) Title V grant.~     Although not guaranteed, preliminary discussions with the IDPH are highly encouraging giving~     the statewide interest in this topic.~   "
67526|NCT02683083|"~     Primary purpose of the clinical study is to evaluate the safety, biodistribution and~     radiation dosimetry of [131I]-SGMIB Anti-HER2 VHH1 in healthy volunteers and patients with~     HER2+ breast cancer.~      Secondary purpose of the clinical study is to evaluate the tumor uptake of [131I]-SGMIB~     Anti-HER2 VHH1 in patients with HER2+ breast cancer.~   "
67527|NCT02683070|"~     Catheter-related bladder discomfort (CRBD) is not uncommon in male patients under general~     anesthesia, and it may cause patient agitation and exacerbated postoperative pain. In this~     study, the investigators will enroll male patients undergoing elective prostate surgery with~     urinary catheterization after anesthetic induction, and compare the efficacy of pudendal~     nerve block (PNB) and intravenous tramadol in prevention of CRBD.~   "
68692|NCT02667808|"~     The aim of this study is to identify reproductive health priorities among individuals living~     with HIV.This study also seeks to explore factors that influence fertility, family planning,~     and sexual behavior among individuals with HIV who are receiving antiretroviral therapy~     (ART).~   "
67529|NCT02683044|"~     Randomized, experimental, non-inferiority clinical trial to determine the comparative~     effectiveness and safety of two protocols used in the treatment of Erectile Dysfunction (ED)~     with Low-Density Shock Waves (Li-ESWT), for patients seen at the Boston Medical Group's~     Bogota center. Protocol 1: Consists of five sessions, one per week, with 3000 pulses at 0,15~     mg/mm2, at a frequency of 4 Hz. The distribution of the shocks will be 2000 pulses to the~     body of the penis and 1000 pulses at its base. Total duration: 5 weeks. Protocol 2: Consists~     of six sessions, two per week, with 1500 pulses each one at 0.1 mJ/mm2, at a frequency of 4~     Hz. The distribution of the shocks will be 900 pulses to the body of the penis and 600 pulses~     at its base. Total duration: 3 weeks.~      Outcome variables: Erection Hardness Score (EHS). International Index of Erectile Function,~     5-item version (IIEF-5). Penile blood flow.~      Evaluation at 1, 3 and 6 months after completing each of the Li-ESWT protocols.~   "
67530|NCT02683031|"~     We aimed to investigate the efficiency of chemical oocyte activation using readymade Ca2+~     ionophore on cases with previously cancelled cases due to fertilization arrest at pronuclear~     stage i.e: cleavage failure to find out if there is any improvement in embryonic~     developmental stages.~   "
67531|NCT02683018|"~     The use of cannabis for severe medical conditions is being legalized in different states,~     increasing the mandate to make cannabis legal for medically ill patients. However, there is a~     lack of placebo-controlled studies investigating the efficacy of cannabis. Dronabinol~     (synthetic, oral Δ-9-THC) is FDA approved for the appetite stimulation in AIDS-related~     anorexia and nausea/vomiting in chemotherapy patients. Nabilone, a synthetic analogue of THC,~     is approved for nausea/vomiting in chemotherapy patients. These medications have been found~     to be effective for these disorders, but there remains an interest in studying cannabis,~     partly due to the numerous cannabinoids contained within the cannabis plant. Among these is~     cannabidiol, which does not produce subjective effects, but has been shown to have potent~     anti-inflammatory effects. In addition, there is data indicating that cannabidiol may be~     effective for neuropathic pain and nausea/vomiting.~      The goal is to investigate the effects of high CBD/low THC cannabis on symptoms such as pain,~     nausea/vomiting, and quality of life in seriously ill participants. While there is data~     beginning to emerge that cannabis may have a beneficial effect on these symptoms, there are~     few placebo controlled, double-blind studies. Additionally, the administration of cannabis to~     medically ill patients may be limited by its subjective effects, such as anxiety,~     intoxication, or paranoia. Most cannabis available today has high levels of Δ-9-THC (about~     15%). By using cannabis that is high in CBD, but low in - Δ-9-THC, it is hypothesized that~     some of these effects can be avoid, while maximizing the therapeutic effects, if any.~   "
67532|NCT02683005|"~     Sofosbuvir and ledipasvir (LDV/SOF) are new directly acting antiviral drugs for the treatment~     of hepatitis C (HCV) that are highly effective, orally administered, well tolerated and~     preclinical evaluations in animal models indicate safe administration during pregnancy. This~     project will evaluate the safety and pharmacokinetics of antenatal LDV/SOF treatment for 12~     weeks during the second and third trimester. If proven to be effective, antenatal treatment~     of HCV with LDV/SOF will prevent maternal HCV-related liver disease, perinatal transmission~     of HCV, and community transmission of HCV.~   "
67533|NCT02682992|"~     The overall purpose of this study is to examine the efficacy of prophylactic low-level laser~     therapy (LLLT) to reduce the incidence of oral mucositis and adverse events in patients~     receiving combined modality therapy consisting of chemotherapy and radiation therapy for head~     and neck cancer.~   "
67534|NCT02682979|"~     Demographically, the geriatric population is expanding. It is also increasingly found in the~     emergency services.However, emergency services are not designed to accommodate these~     patients, whose needs are specific. This population is defined by complex physical and~     psychosocial needs, included in a comprehensive geriatric assessment too complex to be~     carried out in the emergency services.~      Many publications focused on ways to prevent potentially avoidable visits to geriatric~     patients in emergency services. People rely upon a therapeutic limitation code established~     for these patients to determine the intensity of the care that may be given to them. However,~     few geriatric patients arriving in the emergency services were already given such a code.~      As a consequence, the intensity of the care given to these emergency patients is influenced~     by the perception of the functional and cognitive status of the patient, even if part of this~     perception is incorrect. Moreover, it is also well established that the outcome of geriatric~     patients with severe pathologies at admission is often poor and that there is a need to find~     alternatives to the intensive treatment offered.~      The goal of this study will be to determine the prevalence of the presence of a therapeutic~     limitation code in geriatric patients at hospital admission / admission to the emergency~     department, and when they leave the hospital. This will be carried out for all geriatric~     patients residing or placed in nursing homes at the end of the hospitalization.The~     investigators postulate that establishing a therapeutic limitation code for these fragile~     patients, before they leave the hospital for a nursing home, would reduce the number of~     future admissions of these patients in the emergency department.~   "
67535|NCT02682966|"~     This is a prospective study in patients who undergo routine postoperative troponin assessment~     after major (semi-)elective noncardiac surgery. Two groups are created based on postoperative~     troponin levels: Postoperative myocardial injury (PMI) group with troponin I levels ≥ 60 ng/L~     and a control group with troponin levels < 60ng/L. The primary aim of this study is to assess~     the association of PMI with pulmonary embolism. Additionally, the association between PMI and~     obstructive CAD will be investigated.~   "
67548|NCT02682797|"~     Retinoschisis is usually a rare self-limited disease and seldom shows progression. There a~     splitting of the neurosensory retina occurs usually in the inferior temporal. Patients~     usually have good visual acuity and are asymptomatic. Combination of an inner and outer layer~     hole is considered high risk factor for development of a schisis detachment. The most~     important differential diagnosis is an retinal detachment, since if misdiagnosed unnecessary~     treatment is provided. In clinical examination, both can appear very thin and transparent.~      Therefore exact diagnosis of retinoschisis and retinal detachment has to be assessed and~     regular follow-up controls have to be conducted for sufficient recognition of progression.~   "
68722|NCT02667418|"~     The purpose of this study is to determine whether fidaxomicin and vancomycin followed by~     taper and pulse vancomycin treatment are superior to standard vancomycin treatment for the~     treatment of recurrent Clostridium difficile infection.~   "
67536|NCT02682953|"~     This is a pilot study to evaluate the efficacy of hyperbaric oxygen therapy (HBO2) for~     mobilizing hematopoietic progenitor cells from bone marrow to blood. These cells are needed~     for patients to undergo bone marrow transplantation and some patients fail to respond to~     current best chemotherapy. HBO2 has been shown to trigger stem cell mobilization in other~     patient populations and we plan to investigate whether this intervention can act in concert~     with chemotherapeutic agents to allow poor mobilizer patients to achieve successful bone~     marrow transplantation. Twenty patients will be identified by participating hematologists who~     have failed to respond adequately to chemotherapy. When it is deemed appropriate to attempt~     an additional stem cell mobilization protocol, these patients will be administered~     chemotherapy as determined by their primary treating hematologist and additionally receive~     daily HBO2 (2.5 atmospheres absolute [ATA] for 90 minutes) for 3-8 days. At intervals, blood~     samples will be obtained as is the normal transplantation protocol practice to assess whether~     adequate stem cells are present in blood for the patient to proceed with transplantation. The~     project is anticipated to take one year to complete.~   "
67537|NCT02682940|"~     A single center pilot study assessing the Vigilant Diabetes Management System for the~     prevention of recurrent mild to moderate hypoglycemia in type I diabetes patients.~   "
67538|NCT02682927|"~     This is a multicenter, double-blind, parallel-group, placebo-controlled, study to assess the~     efficacy, safety, and PK of ZX008 when used as adjunctive therapy for uncontrolled seizures~     in pediatric and young adult subjects with Dravet syndrome. After an initial Screening and~     Baseline charting of seizure frequency, subjects who qualify for the study will be randomized~     (1:1:1) to receive either ZX008 (0.2 mg/kg/day, 0.8 mg/kg/day; maximum dose: 30 mg/day) or~     placebo. Randomization will be stratified by age group (< 6 years, ≥6 to 18 years). All~     subjects will be titrated to their randomized dose over a 14-day Titration Period. Following~     titration, subjects will continue treatment at their randomly assigned dose over a 12-week~     Maintenance Period. Subjects exiting the study will undergo a 2-week taper, unless they~     enroll in a follow-on study. Subjects will be followed for post-study safety monitoring.~     Parents/caregivers will use a diary daily to record the number/type of seizures, dosing, and~     use of rescue medication.~   "
67539|NCT02682914|"~     The main objective of this study is to determine the risk factors and etiologies of ischemic~     stroke in Korean young adults. Both well-documented risk factors and little known life-style~     related risk factors such as life-style habits, psychological distress including occupational~     distress, perceived stress and depression will be evaluated by comparison with healthy~     controls using a structured questionnaire. Secondary objectives are to determine stroke~     outcomes such as mortality, recurrent vascular events and post-stroke epilepsy in these~     patients.~   "
67540|NCT02682901|"~     The main objective is to demonstrate the effects of early dopaminergic activation on the~     autonomic nervous system in subjects with newly diagnosed vs. established type 2 diabetes.~     The primary endpoint is the effect of Bromocriptine QR on changes in autonomic function~     measured by assessing sympathetic and parasympathetic function using conventional measures of~     autonomic function, including power spectral analysis of heart rate as well as peripheral~     autonomic function using sudorimetry and laser scanning of peripheral microvascular autonomic~     control.~   "
67541|NCT02682888|"~     to examine the association between trait and defensive network connectivity and the~     modulatory effect of oxytocin on it~   "
67542|NCT02682875|"~     The study evaluates with Artificial Neural Network (ANN) of pain scales in children. Pain of~     these patients' will be evaluated by many pain scales in the postoperative period.~   "
67543|NCT02682862|"~     Single centre, open-label, random order, cross-over trial, recruited over a period of~     approximately 2 years. Sufficient participants enrolled to complete 16 adults. Withdrawn~     subjects may be replaced.~      This clinical trial will assess the effects of ultra-long acting bronchodilator therapy in~     smoking asthmatics taking inhaled corticosteroids. This will be via a pulmonary function test~     called impulse oscillometry.~   "
67544|NCT02682849|"~     The purpose of this study is to evaluate the effectiveness of the PleuraFlow® Active~     Clearance Technology™ (ACT) System in the management of blood evacuation after cardiac~     surgery.~   "
67545|NCT02682836|"~     Metastatic breast cancer (MBC) is an incurable disease. Maintaining optimum quality of life~     is a major goal of care. There is a strong body of evidence that exercise can reduce or~     manage fatigue, depression and insomnia in breast cancer patients; however, the evidence base~     is overwhelmingly in early stage cancer patients. The purpose of this study is to see if a~     home-based, self-directed walking program can have similar benefits in women with an MBC~     diagnosis. The primary objective is to evaluate whether engagement in physical activity will~     reduce fatigue during active treatment for MBC (baseline to 3 months); this is the primary~     endpoint. Secondary objectives pertain to feasibility of recruitment and retention of study~     participants and measuring changes between baseline, 3 months and 6 months in additional~     quality of life measures. Exploratory analyses pertain to changes in p16INK4a levels and~     sarcopenia between baseline and 3 months. The design is a single arm intervention trial in 30~     patients. Findings from this study will provide preliminary data for a grant application to~     test the physical activity intervention in a randomized controlled trial (RCT) in a large~     sample of women with metastatic breast cancer.~   "
67546|NCT02682823|"~     This study is designed to evaluate RLHFs concerning administration of the tocilizumab~     autoinjector AI-1000 G2 in adults with rheumatoid arthritis (RA) who have been receiving~     subcutaneous (SC) tocilizumab using the commercially available prefilled syringe and needle~     safety device (PFS-NSD). The study will enroll participants with RA, a subset of whom will be~     assigned to perform self-injection with the AI-1000 G2. Enrolled caregivers (CGs) and health~     care professionals (HCPs) will administer the AI-1000 G2 injection to the remaining study~     participants. The study will enroll approximately 45 participants with RA across three~     cohorts. Group 2 will also include 15 paired CGs to administer the injection, and Group 3~     will include 15 paired HCPs to administer the injection. With an expected drop-out rate of~     20%, the target enrollment (to achieve a final sample/ratio of 45:15:15) will be 95~     individuals overall.~   "
67547|NCT02682810|"~     This is a two-arm, unmasked, randomized, controlled trial to test the effectiveness of the~     Alere Q point-of-care (POC) HIV diagnostic assay for use in resource-poor settings.~   "
67549|NCT02682784|"~     Over one million individuals in the United States meet criteria for cocaine use disorders.~     Relapse rates are highest among cocaine-dependent (CD) populations. Social stress is a~     significant risk factor for relapse. Data from human neuroimaging studies suggest that~     top-down prefrontal cortical inhibition of amygdala activity controls emotional responses~     to social stimuli. A growing literature suggests that hypoactivity in the medial prefrontal~     cortex coupled with increases in amygdala activity underscore the vulnerability of CD~     individuals to relapse. Neuroimaging studies of corticolimbic network activity (functional~     connectivity) have been conducted in CD subjects at rest. Compared with healthy controls, CD~     subjects exhibited lower corticolimbic connectivity and the degree of corticolimbic~     uncoupling was associated with time to relapse. Studies measuring corticolimbic connectivity~     during exposure to a social stress task in CD subjects could provide critical insight into~     the neurobiologic mechanisms that underscore the sensitivity of CD individuals to social~     stress. Moreover interventions that improve corticolimbic connectivity in CD subjects may be~     effective therapeutic strategies for preventing relapse in CD populations. Oxytocin (OT) is~     an anxiolytic neuropeptide that attenuates amygdala responses to aversive social cues. In~     order to better understand the neurobiologic mechanisms that control emotion-related behavior~     in CD populations, we propose a double-blind placebo (PBO) controlled study using blood~     oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI) to measure (1)~     corticolimbic functional connectivity during the Montreal Imaging Stress Task (MIST) and (2)~     amygdala activity in response to an implicit facial affect recognition paradigm in groups of~     CD individuals (CD n=80) and healthy non-dependent controls (HC, n=80). Prior to the scanning~     session, participants will receive either intranasal OT (24 IU) or PBO spray (n=40 per~     treatment group). The order of the tasks will be counterbalanced.~   "
67550|NCT02682771|"~     Obesity, due to excess fat in the thoracoabdominal region, can promote changes in respiratory~     function and lung function, leading to reduction in lung volume and capacity. Such~     dysfunctions are worsen after bariatric surgery to be associated with factors inherent to~     this procedure. The objective of this study was to evaluate and compare the effects of the~     application of bilevel positive airway pressure and exercises with inspiratory pressure with~     linear load in thoracoabdominal mobility, pulmonary function, inspiratory muscle strength,~     respiratory muscle strength and prevalence of pulmonary complications after bariatric~     surgery.~   "
67551|NCT02682758|"~     The influence of xenon anaesthesia on transpulmonary pressure and tidal volume distribution~     will be investigated in a prospective cohort study in 10 patients of normal weight and 10~     obese patients undergoing routine xenon-based, general anaesthesia for surgery.~   "
67552|NCT02682745|"~     The purpose of this study is to assess the pharmacokinetic characteristics of bepotastine~     after single oral administration of TALION tab, a IR formulation of bepotastine as reference~     drug and HL151, a SR formulation of bepotastine as test drug in healthy male adults.~     Additionally the safety and tolerability of two drugs will be evaluated.~   "
67553|NCT02682732|"~     The current understanding of acute myeloid leukemia (AML) is that one site of bone marrow~     (BM) sampling serves as a window that represents all AML cells distributed throughout the BM,~     an assumption that has yet to be questioned. Simulation in mice led to inconsistent~     representation of the full BM, which can incorrectly suggest the absence of leukemic cells.~     Positron-emission tomography (PET) scan can detect areas of high metabolic activity in the~     body using for instance a radioactive sugar. In one report, its use in human AML has provided~     proof-of-principle evidence of unequal distribution of AML cells in BM. Accordingly, the~     alternative hypothesis is to test if PET scan can demonstrate if BM geography can alter AML~     cells spread and home them as distinct areas rather than uniform spread as if they are~     distributed in liquid state.~   "
67554|NCT02682719|"~     The purpose of this study is to determine whether LCZ696 (valsartan/sacubitril) is safe and~     has beneficial effects on the heart and blood vessels in patients with high blood pressure~     and/or diabetes or other risk factors for developing heart failure (elevated levels of~     natriuretic peptide and elevated left atrial volume index). Patients will be randomized to~     receive LCZ696 or valsartan (and matching placebo) for 18 months to assess the impact on left~     ventricular diastolic function.~   "
67555|NCT02682706|"~     Brown adipose tissue (BAT) is unique in its capability to convert chemical energy directly~     into heat. Active BAT increases energy expenditure and can thereby counteract obesity and~     insulin resistance. Currently, the imaging method of choice to assess BAT morphology and~     function is 18F-FDG-PET/CT which is expensive and exposes patients or healthy volunteers to~     ionizing radiation, thus impeding larger prospective studies.~      Magnetic resonance imaging (MRI) could constitute a suitable alternative and preliminary~     small-scale studies are promising.~      The overall aim of this research proposal is to develop reliable magnetic resonance imaging~     techniques to facilitate the study of brown adipose tissue in human adults, specifically in~     the context of endocrine disease.~      Specifically, investigators want to~        1. Develop a reliable MR imaging protocol for human BAT and compare BAT volume to cold~          induced nonshivering thermogenesis as a measure of BAT activity.~        2. Assess the intra-individual variance of BAT volume measured by MRI.~        3. Evaluate direct measurement of BAT temperature by functional MRI.~   "
67556|NCT02682693|"~     Pharmacologic inhibition of RANKL attenuates the development of mammary carcinoma and~     inhibits metastatic progression in multiple mouse models.~      In a retrospective analysis it could be demonstrated that elevated expression of RANK was~     found in 14.5% of patients overall, with a significant predominance in patients with~     hormone-receptor-negative disease. Expression of RANK was associated with a higher~     pathological complete response rate but with a shorter disease-free and overall survival. The~     ABCSG-18 study showed that adjuvant denosumab reduces clinical fractures, improves bone~     health, and can be administered without added toxicity.~      It appears therefore reasonable to test denosumab, a clinically available antibody against~     RANKL in patients with hormone-receptor-negative primary breast cancer as an adjunct to~     neoadjuvant chemotherapy for its ability to increase pCR rate and improve outcome in relation~     to the expression of RANK.~   "
67557|NCT02682680|"~     A 24-week, randomized, open-label study investigating the efficacy, safety and tolerability~     of colesevelam 3.75 g daily compared to ezetimibe 10 mg daily, as an add-on to baseline~     statin therapy in patients with type 2 diabetes mellitus (T2DM) who are not at target for~     glycated hemoglobin (HbA1c) (> 7.0%) and low-density lipoprotein (LDL) cholesterol (> 2.0~     mmol/L).~   "
67598|NCT02682147|"~     This study will use dual energy x-ray computed tomography (DECT) to evaluate the relationship~     between heterogeneous perfusion, hypoxia (low oxygen in inspired gas) and induction of~     pulmonary vascular dilatation to characterize emphysema susceptibility in a normal smoking~     population. The investigators will correlate DECT measures of perfusion with lung injury~     measured by single photon emission computed tomography (SPECT). The investigators will study~     the effect of pulmonary arterial vasodilation to see if it eliminates indices of persistent~     lung injury in smokers that are susceptible to emphysema~   "
67558|NCT02682667|"~     Background:~      Cancer has a major impact in the United States and across the world. In 2015, over 1.5~     million new cases of cancer were diagnosed in the U.S. Researchers want to study samples from~     people with cancer or a pre-malignant condition. They hope to develop more effective~     treatments.~      Objective:~      To better understand the biology of malignancies and why certain cancers respond differently~     to treatment.~      Eligibility:~      Adults at least 18 years old with cancer or a pre-cancerous condition.~      Design:~      Participants will be screened with a medical history, physical exam, and blood tests. Their~     diagnosis will be confirmed by the NCI Laboratory of Pathology.~      Participants will send tissue blocks or slides from their original tumor biopsy.~      At least once, participants will have a medical history, physical exam, and blood and urine~     tests.~      Participants may have the following tests. They may have them more than once:~      Apheresis. A needle in one arm removes blood. Blood is run through a machine and the sample~     cells are taken out. The rest of the blood is returned by a needle in the other arm.~      Bone marrow aspiration and biopsy. The hipbone will be numbed. A needle will be put into the~     hipbone. Bone marrow will be taken out through the needle.~      Piece of cancer tissue taken by a needle and syringe.~      Computed tomography (CT) scan, magnetic resonance imaging (MRI) and/or positron emission~     tomography (PET) scan or ultrasound to help locate their tumor. For the scans, they lie in a~     machine that takes pictures.~      A small piece of skin removed.~      Participants will be contacted by phone once a year to find out how they are doing.~   "
67559|NCT02682654|"~     This study will look to examine the overall performance of a custom fit knee or ankle brace~     as a means of providing ankle or knee joint support in subjects that have determined the need~     for bracing based upon chronic joint instability and/or joint swelling and pain following~     daily activity.~   "
67560|NCT02682641|"~     Phase II study with a two-stage design to evaluate efficacy and safety of ibrutinib in~     combination with rituximab (I+R) in untreated patients with indolent clinical forms of MCL.~      An extensive biological study will be conducted in order to further characterize this~     population of MCL patients and evaluate the response obtained with the mutational profile of~     the tumor.~   "
67561|NCT02682628|"~     To evaluate the Sun Protection Factor (SPF) efficacy on human skin.~   "
67562|NCT02682615|"~     Evaluation of a non-invasive technique to measure cardiac output (esCCO™) with the clinical~     goldstandard of the transcardiopulmonal thermodilution technique (PiCCO®). Effect of~     different potential interference factors to the accuracy of measurement (changing~     concentration of norepinephrine, generally severity of the basic disease - APACHE II score).~   "
67563|NCT02682602|"~     The objective of this study is to analyze subjects having a normal hip and compare the in~     vivo kinematics to subjects requiring a total hip arthroplasty (THA) due to having a diseased~     hip and then later post-operative to their implanted hip. Ten subjects will have a normal~     hip, ten hips will be diseased, requiring a THA and then those ten diseased hips will be~     re-analyzed at six months post-operative after implantation of a THA.~   "
67564|NCT02682589|"~     Randomized, multicenter, phase III trial to compare the short and long outcomes of~     laparoscopic CME with open CME in treating patients with locally advanced colon cancer.~   "
67565|NCT02682576|"~     The objective of the study is to define the analytical repeatability of quantifying~     flow-mediated dilation of the brachial artery using brachial artery ultrasound imaging using~     upper arm cuff occlusion.~   "
67566|NCT02682563|"~     Background:~      Worldwide, diabetic nephropathy or Diabetic Kidney Disease (DKD), is the most common cause of~     chronic and end-stage kidney disease. With the increasing rates of obesity and type 2~     diabetes (T2DM), many more patients with DKD may be expected in the coming years. DKD is a~     multi-factorial condition, involving factors such as obesity, chronic hyperglycemia, advanced~     glycation end products, oxidative stress, pro-inflammatory cytokines, systemic- and~     glomerular hypertension. Large-sized prospective randomized clinical trials suggest that~     intensified glucose and blood pressure control, the latter especially by using agents that~     interfere with the renin-angiotensin-aldosterone system (RAAS), may halt the progression of~     DKD, both in type 1 diabetes and T2DM. However, despite the wide use of~     angiotensin-converting enzyme inhibitors and angiotensin receptor blockers, a considerable~     amount of patients develop DKD during the course of diabetes, indicating an unmet need for~     renoprotective therapies. Sodium-glucose linked transporters (SGLT-2) inhibitors are novel~     glucose-lowering drugs for the treatment of T2DM. These agents seem to exert pleiotropic~     actions 'beyond glucose control', including reduction of blood pressure and body weight. In~     addition, SGLT-2 inhibitors decrease proximal sodium reabsorption and decrease glomerular~     pressure and albuminuria in rodents and type 1 diabetes patients. In rodents, SGLT-2~     inhibitors also improved histopathological abnormalities associated with DKD. To date, the~     potential renoprotective effects and mechanisms of these agents have not been sufficiently~     detailed in human type 2 diabetes. The current study aims to explore the clinical effects and~     mechanistics of SGLT-2 inhibitors on renal physiology and biomarkers in metformin-treated~     T2DM patients with normal kidney function.~      Hypothesis:~      Treatment with the SGLT-2 inhibitor dapagliflozin, as compared to the sulfonylurea (SU)~     derivative gliclazide, may confer renoprotection by improving renal hemodynamics, and~     decreasing blood pressure and body weight in type 2 diabetes.~      Study Design:~      A phase 4, monocenter, randomized, double-blind, comparator-controlled, parallel-group,~     mechanistic intervention trial to assess the effect of 12-week treatment with the~     sodium-glucose linked transporters (SGLT)-2 inhibitor dapagliflozin versus the SU gliclazide~     on renal physiology and biomarkers in metformin-treated patients with type 2 diabetes~     mellitus (T2DM)~      Study Endpoints and methods:~      Renal hemodynamics, i.e. glomerular filtration rate (GFR, ml/min) and effective renal plasma~     flow (ERPF, ml/min) will be measured by the gold-standard inulin- and para-aminohippurate~     (PAH) clearance methods, respectively, during both euglycemic- and hyperglycemic clamp; renal~     tubular function will be measured by 24-hour urine sodium, potassium, chloride, calcium,~     magnesium, phosphate and urea and glucose; markers of renal damage will include urinary~     albumin excretion, neutrophil gelatinase-associated lipocalin and kidney injury molecule-1;~     blood pressure will be measured using an automated oscillometric blood pressure device~     (Dinamap®); body anthropometrics, including body weight, height, body-mass index and waist~     circumference, and body fat contents (by bio-impedance analysis) will be measured; blood~     samples will be obtained to determine glycemic variables, lipids and markers of inflammation;~     systemic hemodynamic variables (including stroke volume, cardiac output and total peripheral~     resistance) will be measured by continuous beat-to-beat hemodynamic monitor (NexFin®); heart~     rate will be determined by oscillometric blood pressure device; microvascular function will~     be measured by capillary videomicroscopy and Laser Doppler; arterial stiffness will be~     assessed by applanation tonometry, (SphygmoCor®); additional urine, blood and feces will be~     collected for conditional determination of various markers of renal damage/function,~     inflammation, oxidative stress and (cardiovascular)-biomarkers and DNA; cardiac autonomous~     nervous system (CANS) will be measured by electrocardiography and NexFin®; insulin~     sensitivity will be measured by glucose infusion during the euglycemic clamp (M-value);~     beta-cell function will be measured by quantification of insulin secretion during the~     hyperglycemic clamp.~      Expected results:~      This active-comparator controlled mechanistic intervention study, using state-of-the-art~     methodology will expand our knowledge regarding the potential renoprotective effects of~     SGLT-2 inhibitors in human T2DM. The investigators hypothesize that SGLT-2 inhibitors may~     confer renoprotection by improving renal hemodynamics, and decreasing blood pressure and body~     weight, all important factors in the development of DKD. Ultimately, the investigators expect~     that this study will contribute to guiding clinicians in their decision-making process of~     individualizing therapies for T2DM patients at risk for, or suffering from, DKD.~   "
67567|NCT02682550|"~     The NTF_PT_2014 multicenter study aims to collect, store, and analyse plasma and serum from~     polytrauma-patients (injury severity score ≥25) and corresponding clinical data to address 1)~     how trauma modulates the release of danger molecules, inflammatory mediators, coagulation~     factors and novel biomarkers, 2) how the specific injury pattern affects the posttraumatic~     response and regenerative potential on an organ-, cell, and molecular level, and 3) how could~     a specific organ- and immune-monitoring predict the clinical outcome.~   "
67568|NCT02682537|"~     Assessment of resting energy expenditure (REE) by indirect calorimetry (IC) in 1400 healthy~     individuals for arithmetical transformation into an bedside tool to estimate energy~     requirements in dietary practice (BASAROTs). A multinational, multicenter, prospective~     cross-sectional study.~   "
67569|NCT02682524|"~     A multicenter, randomized, double-blinded, parallel, active-controlled, phase IV clinical~     trial to evaluate the efficacy and safety of PlbCR and aceclofenac in the treatment of~     patients with osteoarthritis of the knee~   "
67570|NCT02682511|"~     The purpose of this phase 2 multicenter, randomized, double-blind, placebo-controlled, study~     is to assess the safety and efficacy of ifetroban in patients with diffuse cutaneous systemic~     SSc (dcSSc) or SSc-associated pulmonary arterial hypertension (SSc-PAH).~   "
67571|NCT02682498|"~     This study seeks to determine whether a new sustained-release local anesthetic solution~     (Exparel - Liposomal Bupivacaine) injected into the soft tissues around the joint after~     surgery will decrease opioid consumption and adverse events in opioid-tolerant patients~     presenting for total knee arthroplasty. The research hypothesis is that the Exparel (study)~     group will use less opioid in the first 48 hours post-operatively than the control group.~   "
67581|NCT02682368|"~     Acute gallbladder pathology and acute diverticulitis are common conditions met in emergency~     departments and comprise the bulk of admissions throughout general surgical calls. Both~     entities need imagistic description to tailor further management, which may be not readily~     available at the moment of patient's presentation. These delays may lose the window of~     opportunity for timed, quality decision making and may induce increased length of stay and~     subsequent increased costs.~      Ultrasound scanning has become very popular over the last half century and the equipment has~     become more compact, of a higher quality and less expensive, which has facilitated the growth~     of point-of-care ultrasonography - POCUS - that is, ultrasound performed and interpreted by~     the clinician at the bedside. The concept of an 'ultrasound stethoscope' is rapidly moving~     from theory to reality.~      There are a number of studies and case reports that are highlighting the advantages of POCUS,~     but still common grounds need to be sought after. Some countries, like USA and Germany,~     incorporate basic ultrasound in their resident's curriculum among different specialties.~      In the author's knowledge and based on the literature, there are a few-second-to-none studies~     regarding POCUS involving strictly the surgeons. The hypothesis of this study is that,~     surgeon performed ultrasound can be as accurate as the radiologists' findings for basic~     diagnostics in the aforementioned pathology, leading to real time decision making in the~     benefit of the patient.~      The closing remark is that by learning and doing these procedures the surgeon performing~     POCUS doesn't undermine his/her radiologist colleague's authority and skill. The big picture~     is that some basic tasks are transferrable and if used in an appropriate and methodical~     manner the final common goal - the benefit of the patient - is readily achieved.~   "
67572|NCT02682485|"~     Rationale: The surgical complication of intestinal anastomotic leak remains a clear and~     present danger to patients despite advances in surgical technique and ever more powerful~     antibiotics. No surgeon is immune from this complication and leak rates have not changed in~     decades. The consequences of a leak (peritonitis, sepsis, death) can be so severe that in the~     case of rectal cancer, diverting ileostomies are routinely performed to divert the fecal~     stream away from the healing anastomosis. We have recently discovered that certain intestinal~     bacteria, with the capacity to express collagenase and cleave MMP9 (Matrix metallopeptidase~     9) to its active collagen degrading form, play a key and causative role in anastomotic leak.~     These bacteria often escape elimination due to the failure of current antibiotic regimens and~     their delivery methods to remain functionally durable at anastomotic tissue sites.~      Purpose: This phase II clinical trial will track, in real time, the process of anastomotic~     healing and its associated microbiome by performing serial endoscopic surveillance (SES)~     following rectal cancer resection. By capturing anastomotic images and the associated~     microbial and inflammatory mediators from anastomotic fluids via SES performed at three time~     points following rectal cancer resection, we will correlate healing to microbial composition~     and inflammatory mediator status. Patients will be randomized and, at each time point, will~     receive lavage of their anastomosis with either saline or a triple antibiotic solution~     (ciprofloxacin, metronidazole, neomycin). An anastomotic healing score captured during SES~     will be compared between the two treatment arms and correlated to microbial and inflammatory~     mediator analyses of fluid samples to determine how intestinal microbes influence the process~     of anastomotic healing.~   "
67573|NCT02682472|"~     Admission into a care home for people with dementia has been linked with both positive and~     negative psychological outcomes for both the resident and their carers. Whilst some people~     with dementia adjust quickly, many never adjust at all or adjustment is complex and linked to~     cognitive and behavioural decline (Wilson et al, 2007). Therefore, support for healthy~     adjustment is needed.~      Recent research (Aminzadeh et al., 2013; Sury, Burns and Brodaty, 2013, Sussman and Dupuis,~     2013) has identified factors that influence different relocation outcomes and prevent adverse~     reactions. There are currently no interventions that support successful adjustment by~     emphasising the positive factors found to influence relocation outcomes while mitigating the~     effects of negative influences and addressing any missed pre-admission procedures, reported~     in the literature.~      The current project seeks to design an intervention that predominantly builds on the work of~     Sury et al (2013) and focuses on promoting healthy adjustment through an enhanced best~     practice based admission process.~      The intervention will be developed through systematic review of the literature and~     consultation with professional experts, service users, care home staff and carers. The~     current study will serve as a feasibility (pilot) study and test the acceptability of the~     intervention design, examine recruitment and dropout and establish sample size for future,~     larger studies. It also aims to examine whether the intervention indicates an improvement in~     residents' quality of life, mood, overall adjustment and carer satisfaction with care.~      All participants will receive a subset of the same intervention, specifically tailored to~     their needs and with elements delivered by staff, carer or psychologist. Staff and~     researchers will assess the improvement indicators mentioned above using relevant~     psychometric measures at baseline, post intervention completion and at one-month follow up.~     Indirect measures (interviews and staff field notes) will also be used to indicate~     intervention fidelity and feasibility.~   "
67574|NCT02682459|"~     The natural course of extracapillary glomerulonephritis is severe leading to End-Stage Renal~     Disease (ESRD) or death in most cases. Despite immunosuppressive treatment, long-term renal~     outcome remains poor since active crescents usually progress to fibrotic scars with~     glomerular occlusion and disruption.In experimental models Angiotensin Converting Enzyme~     (ACE)-inhibitor therapy targeting the over-expression of angiotensin type 1 (AT1) receptors,~     that are responsible for dysregulated proliferation of parietal cell progenitors, blocks the~     formation of crescents and their fibrotic evolution. Should these drugs have similar effects~     in humans, ACE-inhibitor therapy on top of standard immunosuppression might be instrumental~     to prevent ESRD and promote renal function recovery in clinical practice.~   "
67575|NCT02682446|"~     After endoscopic resection of early gastric cancer (EGC), there remained concerned about the~     development of the metachronous gastric neoplasm (MGN). The aim of this study was to evaluate~     the role of H. pylori eradication for reducing MGN after ESD and the efficacy of serum~     pepsinogen (PG) for predicting development of MGN after endoscopic submucosal dissection~     (ESD) for EGC and to evaluate other risk factors for the incidence of MGN. The investigators~     enrolled the participants who were tested serum PG I and II at the time of ESD for EGC, from~     January 2007 to May 2013 in single tertiary center, retrospectively. The baseline~     characteristics of the participants, H. pylori status, and serum pepsinogen were analyzed for~     the development of the MGN.~   "
67576|NCT02682433|"~     Uterine cavity diseases can cause mild to severe symptoms, and may indicate the functional~     problems of the female reproductive system. Many articles examine the efficacy of diagnostic~     hysteroscopy compared to sonohysterography in the diagnosis of uterine cavity diseases. Most~     of the articles are from the last decade, but the subject has been laid aside in the recent~     years. Antonio Simone Lagana and his group have found that there is 100% correlation in~     uterine cavity structure between diagnostic hysteroscopy and sonohysterography, and only 78%~     correlation when it comes to intrauterine fibroids and polyps. Walid El-Sherbiny, MD and his~     group have found that there is a significant advantage to three-dimensional sonohysterography~     over two-dimensional in the diagnosis of uterine cavity diseases. No significant difference~     was observed, and 97% correlation was found, comparing three-dimensional sonar and~     hysteroscopy. Work rationale is that there is a reason to reconsider the status of the~     diagnostic hysteroscopy to sonohysterography due to evolving technologies, and an improvement~     in resolution and three dimensional technologies.~   "
67577|NCT02682420|"~     Prospective, multi-center study to evaluate the everlinQ endoAVF System when used to create~     an endovascular arteriovenous fistula (endoAVF) for patients who require vascular access for~     hemodialysis.~   "
67578|NCT02682407|"~     The purpose of this study is to evaluate the safety and tolerability of OMS721 in subjects~     with IgA Nephropathy (IgAN), Lupus Nephritis (LN), Membranous Nephropathy (MN), and C3~     Glomerulopathy (C3G), including Dense Deposit Disease. The study will also evaluate~     Pharmacokinetics (PK), Pharmacodynamics (PD), anti-drug antibody response (ADA), and~     neutralizing antibodies (Nab).~   "
67579|NCT02682394|"~     Prognostic Importance of Quantitative Magnetic Resonance Imaging for Evaluation of Pancreatic~     Steatosis in Patients with Pancreatic Cancer~   "
67580|NCT02682381|"~     Teduglutide is approved for treatment of adults with short bowel syndrome (SBS). The purpose~     of this study is to evaluate the safety and efficacy of teduglutide in children up to the age~     of 17 with SBS who are dependent on parenteral support. Subjects may choose whether to~     receive the study drug or to participate in a standard-of-care arm. All participants who~     complete the study may be eligible to receive the study drug in a long-term extension study.~   "
67582|NCT02682355|"~     Polymyxin B is already being used extensively in the USA and other parts of the world; its~     use is likely to rapidly increase due to the greater burden of infections caused by MDR~     Gram-negative bacteria and the growing awareness of the limitations inherent in the clinical~     pharmacology of CMS/colistin. Cross resistance exists between the two polymyxins and thus~     both must be dosed optimally; but the recently generated scientifically-based dosage regimens~     for CMS/colistin cannot be extrapolated to polymyxin B. It is essential that an adequately~     powered study is conducted to define the clinical PK/PD/TD relationships of polymyxin B and~     identify, using next-generation proteomics, biomarkers for early detection of kidney injury.~     This will allow the development of scientifically-based dosage regimens for various~     categories of patients and an adaptive feedback control clinical tool for optimized dosing of~     polymyxin B in future individual patients.~   "
67583|NCT02682342|"~     In this study, the investigators will test the hypothesis that acute in vivo exposure to~     hyperglycemia increases mitochondrial network fragmentation and mitochondrial reactive oxygen~     species production (ROS) production in human arterial endothelial cells.~   "
67584|NCT02682329|"~     To determine the effectiveness of combining different concentrations of hydrogen peroxide and~     carbamide used during tooth bleaching.~   "
67585|NCT02682316|"~     The purpose of this study is to compare any good and bad effects of using the Prevena~     Incision Management System to using the usual standard dry gauze approach. The Prevena~     Incision Management System is a type of Negative Pressure Wound Therapy (NPWT). NPWT is a~     portable vacuum device made of a sponge-like foam that is applied over your incision to help~     draw fluid and debris out after surgery.~   "
67586|NCT02682303|"~     Purpose: To report the immediate and prolonged (one week) effects of elastic bandage on~     balance control in subjects with chronic ankle instability.~      Material and methods: Twenty-eight individuals successfully completed the study protocol, of~     whom 14 were randomly assigned to the elastic bandage group (7 men, 7 women) and 14 were~     assigned to the non-standardized tape group ( 9 men, 5 women). To objectively measure~     postural sway we used computerized dynamic posturography with Sensory Organization Test and~     Unilateral Stance test. We analyzed the following Sensory Organization Test parameters: the~     composite Sensory Organization Test score, the composite Sensory Organization Test strategy~     and the Sensory Organization Test condition 2 and its strategy. In addition, we studied the~     centre of gravity sway velocity with open eyes and close eyes during the US test.~   "
67587|NCT02682290|"~     This is a proof of concept study. The aim of this study is to assess a device measuring~     rheological properties of human sputum of four populations :~        -  10 patients with Broncho Chronic Obstructive Pulmonary Disease (COPD)~        -  10 patients with asthma~        -  10 patients with cystic fibrosis~        -  10 healthy volunteers.~   "
67588|NCT02682277|"~     The polyglucosamine, specification L112, is a medical device and in this clinical trial used~     for weight reduction in moderately obese participants following a long term treatment lasting~     12 months. The rationale for this study is to show that overweight can be reduced by taking 2~     times daily 2 tablets with the main meals.~   "
67589|NCT02682264|"~     The primary objective of this study is to determine the long-term safety of CB-03-01 cream,~     1% applied twice daily for an additional nine months in study participants with acne vulgaris~     that participated in the Phase 3 pivotal studies for a total treatment of up to 12 months.~   "
67590|NCT02682251|"~     An interventional study to empower congestive heart failure patients who have a cardiac~     resynchronization therapy-cardiac implantable electronic device (CRT-CIED) by using a~     personal health record (PHR) to directly message them their device data and send alerts based~     on percent left ventricular pacing.~   "
67591|NCT02682238|"~     To assess the safety and local tolerability of BBI-4000 15% gel compared with vehicle~     (placebo) when applied topically once daily in subjects with palmar hyperhidrosis.~   "
67592|NCT02682225|"~     The primary objective of this study is to evaluate the abuse potential of intranasal~     esketamine (112 milligram and 84 mg) compared to racemic intravenous ketamine (0.5 mg/kg) in~     nondependent, recreational polydrug users of perception-altering drugs.~   "
67593|NCT02682212|"~     The main objective is to investigate effects of perineal trauma at birth on women´s health~     and whether early physiotherapy improves pelvic floor strength. This will be achieved by an~     acknowledged/validated questionnaire sent electronically 6 weeks after first delivery. Women~     with symptomes of urinary incontinence according to the questionnaire will be offered~     participation in a single-blinded randomized intervention study to compare outcome after~     targeted physiotherapy with conventional advice and support. Intervention encompasses weekly~     pelvic floor training for 12 weeks. Pelvic strength will be measured and symptom information~     collected before and after intervention and 12 months postpartum in both groups.~      Pelvic floor problems after delivery are common and often persistent, including urinary/fecal~     incontinence, pelvic organ prolapse and sexual problems. Such symptoms reduce QoL and~     handicap women in multiple ways, physically, psychologically and socially. More knowledge of~     whether interventions and guidelines in this field can improve health and QoL is required.~   "
67594|NCT02682199|"~     The goal of this prospective observational study is to investigate whether whole brain~     radiation leads to measurable xerostomia from parotid gland toxicity.~   "
67595|NCT02682186|"~     Breast augmentation is among the most popular surgical procedures performed in the world with~     approximately 1,773,584 performed in 2013. This surgical intervention generates important~     pains during postsurgical recovery. A multimodal analgesia, based on the recommendations is~     proposed to the patients .The pectoral nerve block is an innovative technique of locoregional~     anesthesia that has already been successfully used in breast surgery. Its realization is~     fast, simple, and it would be superior compared with a paravertebral block within the~     framework of mastectomy. The interest of this technique has never been assessed in esthetic~     breast surgery. The aim of this study is to evaluate the analgesic efficacy of the~     association of  Pecs blocks 1 and 2  on pain intensity after breast augmentation surgery.~   "
67596|NCT02682173|"~     Fatty liver in the obese is a common finding; some cases develop steato-hepatosis which in~     the long-term can lead to liver cirrhosis. The effect of bariatric surgery on fat~     distribution in the liver has so far been studied with liver biopsies and single voxel MR~     techniques. With this trial investigators present a new, whole organ MR-quantification of~     liver fat and describe changes after bariatric surgery in visceral and subcutaneous fat.~   "
67599|NCT02682134|"~     The aim of this interventional study is to find out the incidence of sore throat among~     intubated patients in Jordan university hospital and to find out which is preventive and~     effective method to decrease sore throat;is it xylocaine gel on endotracheal cuff as~     lubricant versus dexamethasone 8 mg intravenously or both.~   "
67600|NCT02682121|"~     Diabetes mellitus (DM) imposes an approximate 2-fold increased risk of atherothrombosis.~     Patients with type 2 DM have a 2- to 4-fold increase in the risk of coronary artery disease~     (CAD) and atherothrombotic complications. Current evidence indicates that altered platelet~     function and reactivity are key determinants of arterial and venous thrombosis in metabolic~     syndromes. In addition, venous thrombosis and pulmonary embolism are associated with~     increased body mass index, a common feature of type 2 DM and the metabolic syndrome. Altered~     platelet behavior, function, and phenotype may be critical factors in these thrombotic~     complications as well. The mechanisms that lead to altered phenotype and function of~     platelets in DM, and that underlie heightened contributions of platelets to thrombotic~     complications in type 2 DM, are nevertheless incompletely understood. In this project, the~     investigators will prospectively determine if clinical intervention with metformin--a~     commonly-used therapeutic agent that reduces blood glucose, promotes weight loss, and~     improves lipid profiles--reverses platelet reprogramming and hyperreactivity in obese~     subjects with impaired fasting glucose and thus, at-risk for type 2 DM.~      In addition to metformin, all participants will be given lifestyle modification (LSM)~     education on diet and physical activity, followed by guidance on how to adhere to the LSM,~     depending on random assignment to intervention group (education only (n=26) vs.~     implementation intentions alone (n=27) vs. implementation intentions with partner (n=27)).~     The LSM coaching for different intervention groups will allow the investigators to test~     whether there are more effective ways for adherence than others. Participants in these three~     LSM intervention groups will be further randomized to either Metformin (n=40) or Placebo~     (n=40), such that participants in the three LSM groups will be randomly and evenly~     distributed across the two study medication groups.~   "
67601|NCT02682108|"~     Several noninvasive radiological techniques have been investigated for the diagnosis of liver~     fibrosis and cirrhosis among patients with chronic infection with hepatitis B virus or~     hepatitis C virus. Diffusion-weighted magnetic resonance imaging (DW-MRI) is a particularly~     appealing method for the diagnosis of liver fibrosis. The aims of this study are to evaluate~     the accuracy of DW-MRI in patients with chronic viral hepatitis for determining the stage of~     liver fibrosis.~   "
67602|NCT02682095|"~     The purpose of the study is to get an understanding about what problems patients with~     hypertension are facing, how they manage these challenges, how they feel and what~     requirements they believe are important to have in their treatment. These factors will later~     act as a foundation and incentive for designing an intervention that may result in more~     patients achieving blood pressure control with maintained quality of life.~   "
67603|NCT02682082|"~     The goal of this project is to determine if EUS-CPN without Bupivacaine (versus EUS-CPN with~     Bupivacaine) can reduce pain scores and improve quality of life in patients with inoperable~     pancreatic cancer by reducing the morbidity due to narcotic side effects (e.g. nausea,~     excessive sedation, constipation).~   "
67604|NCT02682069|"~     This is a non-randomized evaluation for which 50 patients will be imaged at the Southwest~     Regional Wound Care Center, Lubbock, Texas, who present with a chronic wound and are~     receiving standard treatment. The MolecuLight i:X Imaging Device will be used as an~     adjunctive tool in the assessment of the wound and will be used to guide the targeted~     sampling of a wound (punch biopsy method).~   "
67605|NCT02682056|"~     This study will compare three glucose measurement techniques among diabetic children and~     adolescents. The study seeks to determine if a microneedle patch (made from biocompatible~     polymers or metal), versus a lancet or intravenous catheter, would be a preferable option for~     monitoring glucose levels among the diabetic pediatric population.~   "
67606|NCT02682043|"~     The purpose of this study is to investigate parental attitudes towards their child who has a~     mobility impairment, to using a modified electric toy car, and to evaluate from their~     perspective, if it facilitated social interaction for their child with mobility impairment.~   "
67607|NCT02682030|"~     The investigator is examining the use of one airway clearance medical device compared to the~     use of two airway clearance medical devices together in patients with amyotrophic lateral~     sclerosis (ALS). More specifically, the investigator wants to know how effective the use of~     either a mechanical High Frequency Chest Compression (HFCC) device is on its own or the use~     of both a mechanical High Frequency Chest Compression (HFCC) device and Cough Assist together~     to maintain a healthy airway and clear secretions.~      The first device is a passive form of mechanical High Frequency Chest Compression (HFCC),~     which was designed to help clear the airway of mucus and other secretions through mechanical~     knocking of the chest area. The second device, called a Cough Assist, aids patients to clear~     mucus and secretions that they would otherwise be unable to clear with coughing. This study~     will enroll up to 20 people in total at CSMC.~   "
67608|NCT02682017|"~     Red meat makes a significant contribution to the human diet. The most widely consumed meat~     globally is pork which accounts for 36% of overall meat intake with beef and poultry~     contributing 22% and 35%, respectively. Pork meat provides a range of important nutrients~     including protein, zinc, B-vitamins and a range of important minerals however there is~     accumulating evidence to suggest that consuming red meat and processed meat increases the~     risk of cardiovascular disease (CVD) and colon cancer. Despite these reports of a negative~     impact on health, global pork consumption continues to increase and there are increasing~     efforts to improve the nutritional profile of pork meat through the development of novel~     porcine feed regimens. The manipulation of pig feed to produce 'healthier' meat and meat~     products offers a feasible approach to reduce the risk of preventable disease. Furthermore,~     recent projections of an increased global demand for pork and poultry, particularly in China,~     have highlighted the increasing strain that will be placed on the supply of grains and the~     need to find alternative and sustainable feed ingredients. Macroalgae is emerging as a~     potential sustainable source of novel bioactive ingredients for the animal feed industry with~     some species known to be a good source of protein, minerals, polyunsaturated fatty acids and~     a range of fibre components including fucoidan and laminarin.~      The polysaccharides, laminarin and fucoidan, which are found in abundance in brown seaweed,~     are gaining increasing attention as a potential bioactive feed ingredients with putative~     antioxidant, anti-inflammatory and immunomodulatory activities. Incorporation of a~     laminarin/fucioidan mix (LAM/FUC) into the porcine diet was shown to result in lower levels~     of lipid oxidation in fresh pork steaks. Numerous studies to date have also investigated the~     health promoting effects of LAM/FUC through modulation of the porcine gut microbiota which~     was shown to enhance inflammatory cytokine expression in response to pathogen recognition and~     also to increase piglet performance post weaning.~      The uptake and fate of fucoidan in humans remains unknown albeit after consumption, unaltered~     fucoidan has been detected in human plasma after ingestion suggesting at least partial~     bioavailability of this compound. A study by Moroney et al. (2015) using an in vitro~     bioavailability Caco-2 model provided indications that fucoidan was bioavailable and that it~     may have potent antioxidant potential.~      The primary aim of this randomised parallel placebo controlled human intervention trial was~     to investigate if consuming pork meat from pigs supplemented with a LAM/FUC mix, in addition~     to their normal diet, would impact on blood oxidant and inflammatory status of healthy~     adults. The secondary aim was to determine the effect of consuming LAM/FUC fed pork meat on~     lymphocyte DNA damage, lipid status and immune function in healthy adults.~   "
67609|NCT02682004|"~     After vaginal delivery, all of the participants will evaluate by using Edinburg depression~     scale and venous blood sample will obtain. Postpartum depression will consider the result of~     scale 13 and above according to Turkhish translate. Then leptin, adiponectin and serotonin~     level will compare between depressed and nondepressed women.~   "
67610|NCT02681991|"~     Renamezin Capsule (an oral adsorbent) lowers indoxyl sulfate levels in patient with chronic~     renal failure.~      120 patients with chronic renal failure(baseline serum creatinine:1.5-5.0mg/dl).~      Renamezin is administered 6.0mg/day. The treatment period is 2 months. The change in serum~     indoxyl sulfate will be evaluated.~   "
67611|NCT02681978|"~     This study evaluates the effect of ivabradine on endothelial function in patients with~     coronary artery disease (CAD) after complete revascularization with percutaneous coronary~     angioplasty (PCI). At least 30 days after PCI, patients will be randomized to receive~     ivabradine 5 mg twice daily or to continue with standard medical therapy.~   "
67612|NCT02681965|"~     Proposed is a 6-month randomized controlled trial, in 200 overweight or obese Stage I-IIIC~     breast cancer survivors examining 6-month changes in: 1) body weight, 2) diet, 3) physical~     activity, and 4)quality of life in women randomized to receive the modified LEAN intervention~     compared to women randomized to wait-list control (i.e., the wait-list control will receive~     the modified LEAN intervention after completing the 6-month study).~   "
67613|NCT02681952|"~     A Multicenter, Randomized, Open-labeled, Cross-over, Active-controlled, Phase IV Clinical~     Trial to Evaluate the Preference of Formulation and the Efficacy and Safety of Renamezin and~     Kremezin in Pre-dialysis Patients With Chronic Renal Failure~   "
69331|NCT02659462|"~     prospective cardio respiratory evaluation for patients post the Fontan palliation for single~     ventricle, compared to subjects post successful cardiac repaired surgery compared to healthy~     volunteers in order to evaluate the functional capacity and the primary etiology for~     reduction in functional capacity.~   "
67614|NCT02681939|"~     This is a study to investigate the effect of Tulsi (Ocimum sanctum Linn.) on metabolic and~     biochemical parameters in young overweight and obese subjects. Thirty overweight/obese~     volunteers will be divided into two groups. The first group will receive no intervention. The~     second group will be supplemented with one capsule of Tulsi orally every morning and evening~     in empty stomach for 60 days. The metabolic parameters and liver enzymes will be evaluated~     before and after the intervention.~   "
67615|NCT02681926|"~     Pulmonary vein isolation (PVI) is the cornerstone of atrial fibrillation (AF) ablation. A~     novel technology was recently developed to allow an automatic points annotation when indirect~     parameters of lesion formation reach predefined target values.~      The aim of the study was to evaluate, in a prospective and multicenter study, the safety,~     efficiency and PVI effectiveness of a new ablation tracking tool (VISITAG; Biosense Webster)~     during paroxysmal AF ablation using a contact force sensing catheter.~   "
67616|NCT02681913|"~     Myocardial protection is a major issue in cardiac surgery, since inadequate protection~     increases the risk of postoperative cardiac dysfunction. The main principle of myocardial~     protection in cardiac surgery is to preserve myocardial function by preventing ischemia with~     blood cardioplegia . Previous studies have shown that adenosine as an adjunct to blood~     cardioplegia can be safely used in cardiac surgery. In the Amphia Hospital, adenosine is~     already used as standard care as an initial cardioplegic bolus in minimally invasive port~     access operations. Whether, adenosine as an adjunct to intermittent warm blood cardioplegia,~     has an added value remains unclear. Therefore the investigators would like to investigate the~     effect of the addition of adenosine to standard intermittent warm blood cardioplegia in~     patients scheduled for minimally invasive, port access operations (mitral valve surgery).~      Half of the participants will receive standard intermittent warm blood cardioplegia, while~     the other half will receive intermittent warm blood cardioplegia enriched with adenosine.~   "
67617|NCT02681900|"~     This study tests the effects of a self-affirmation manipulation on (i) acceptance of a health~     message detailing the risks of alcohol consumption, (ii) engagement with the health message~     and (iii) alcohol consumption at 7-day follow-up. Half of the participants complete a~     self-affirmation manipulation, where they reflect on their most important values, whereas the~     other half complete a control equivalent, where they reflect on their least important values.~     Immediately post-intervention, all participants then receive information about the risks of~     alcohol consumption and complete measures of message acceptance and engagement with the~     materials. Seven days after intervention, participants self-report their alcohol consumption~     in the previous 7 days.~   "
67618|NCT02681887|"~     In a 12 week double-blind, placebo-controlled randomized trial, 120 subjects with obesity~     (BMI≥30 kg/m2) and pre-diabetes (HbA1c, 5.7-6.4%) will be randomly assigned 1:1 to receive~     either placebo or 2 mg of controlled-release melatonin, taken orally every evening 1 hour~     before bed. The investigators will assess melatonin's effect on insulin sensitivity by~     performing a hyperinsulinemic euglycemic glucose clamp and β-islet cell function measured~     using a hyperglycemic clamp, as a primary endpoint. The investigator will also evaluating~     melatonin supplementation's effect on mean 24-hour ambulatory blood pressure, nocturnal blood~     pressure, and potential intermediates including endothelial function using brachial~     ultrasound, catecholamine production using 24-hour epinephrine and norepinephrine excretion,~     and renin-angiotensin system activation using measurements of plasma renin activity,~     angiotensin II, and urine aldosterone excretion. The final endpoint will be to evaluate~     melatonin supplementation's effect on cellular cytokine and CC family chemokine expression as~     well as high sensitivity C-reactive protein, IL-6, and TNF-α.~      There will be a 24 week cohort phase as an extension of the trial. This will be an open-label~     prospective study of 50 subjects recruited from the trial who will take 2 mg of~     controlled-release melatonin nightly for 24 weeks after completion of the 12-week trial. At~     the end of the cohort-phase (36 weeks after entry in the trial), the investigators will again~     assess the extended use of melatonin supplementation on 24-hour BP, and glycemic control~     (HbA1, fasting glucose).~   "
67619|NCT02681874|"~     Many behavioral interventions designed to improve dietary patterns for ethnic and~     racial/minority preschoolers have produced modest outcomes. A limitation of these~     interventions include a failure to address key factors associated with dietary patterns for~     these children, such as parental stress levels. Therefore, the identification of intervention~     models that target these factors and are effective, acceptable, and feasible among parents of~     young minority children is important.~      Subjects will be asked to take part in this study because they are the parents of a child~     that receives care at a Texas Children's Pediatrics (TCP) clinic where the study is being~     done and their child's body mass index has been at or above the 85th percentile.~      The purpose of this pilot study is to assess the ease and acceptance of providing an~     intervention for parents of children ages 2-5 years in the pediatric primary care clinic. The~     purpose is to also assess how well the intervention works in improving the child's dietary~     patterns.~   "
67620|NCT02681861|"~     The purpose of this study is to evaluate the safety and tolerability of single ascending~     intravenous doses and single subcutaneous (sc) doses of ASP6294 in healthy young male and~     female subjects.~      This study will also evaluate the pharmacokinetics (pk) of single ascending intravenous doses~     and single ascending sc doses of ASP6294; determine the effect of ASP6294 administered~     intravenously and sc on the serum levels of circulating total Nerve Growth Factor (NGF);~     explore a potential gender difference in safety, tolerability and pk of single intravenous~     dose and single sc doses administrations of ASP6294 as well as determine the maximum~     tolerated dose (MTD) of single intravenous doses and single sc doses of ASP6294.~      Part 2 will also evaluate the relative bioavailability of ASP6294 when administered sc.~   "
67656|NCT02681393|"~     It is essential that individuals living with stroke engage in physical activity to improve~     cardiovascular risk factors and reduce the risk of stroke (Billinger et al, 2014). This~     objective of this study is to examine the effectiveness of an educational brochure that~     promotes exercise in people with stroke, combined with a motivational telephone support, on~     maintaining physical activity. Fifty participants with stroke will be enrolled. This study~     will provide insight into implementing effective tools that are designed to help individuals~     with stroke maintain physically active behaviours in the long-term.~   "
69332|NCT02659449|"~     The purpose of this study is to determine the impact of compressing therapy on the dexterity~     of burned hands using evaluating hand function tests (Box and block / Purdue Peg Board /~     Jamar's test)~   "
67621|NCT02681848|"~     Introduction: Smoking is a major avoidable cause of ill-health and premature death.~     Treatments that help patients successfully quit smoking have an important effect on health~     and life expectancy. Varenicline is a medication that can help smokers successfully quit~     smoking. However, there are concerns that it may cause adverse effects, such as increase in~     the occurrence of depression, self-harm and suicide and cardiovascular disease. In this study~     the investigators aim to examine the effects of varenicline versus other smoking cessation~     pharmacotherapies on smoking cessation, health service use, all-cause and cause-specific~     mortality and physical and mental health conditions.~      Methods: In this project the investigators will investigate the effects of varenicline~     compared to nicotine replacement therapies on: (1) long-term smoking cessation and whether~     these effects differ by area level deprivation; and (2) the following clinically-important~     outcomes: rate of general practice and hospital attendance; all-cause mortality and death due~     to diseases of the respiratory system and cardiovascular disease; and a primary care~     diagnosis of respiratory illness, myocardial infarction or depression and anxiety. The study~     is based on a cohort of patients prescribed these smoking cessation medications from the~     Clinical Practice Research Datalink (CPRD). The investigators will use three methods to~     overcome confounding: multivariable adjusted Cox regression, propensity score matched Cox~     regression, and instrumental variable regression. The total expected sample size for analysis~     will be at least 180 000. Follow-up will end with the earliest of either an 'event' or~     censoring due to the end of registration or death.~      Ethics and dissemination: Ethics approval was not required for this study. This project has~     been approved by the CPRD's Independent Scientific Advisory Committee (ISAC). The~     investigators will disseminate the findings via publications in international peer-reviewed~     journals and presentations at international conferences.~   "
67622|NCT02681835|"~     We therefore designed this randomized crossover study to compare C-MAC with Macintosh~     laryngoscope in emergency intubation performed by paramedics according to three different~     intubator positions.~   "
67623|NCT02681822|"~     To study the impact of genetic and environmental factors on high-level cognition associated~     neural circuits among healthy young Chinese Han subjects.~   "
67624|NCT02681809|"~     The purpose of this study is to assess the efficacy and safety of up to 3 intravitreal~     injections of ocriplasmin (0.0625mg or 0.125mg), in subjects with moderate to very severe~     non-proliferative diabetic retinopathy (NPDR), to induce total posterior vitreous detachment~     (PVD) in order to reduce the risk of disease progression to proliferative diabetic~     retinopathy (PDR).~   "
67625|NCT02681796|"~     The rationale for this study is to investigate the benefits of epidural analgesia in~     pancreatic resections in a prospective, single blind, randomized control trial. This study~     will evaluate both short and long-term outcomes related to epidural analgesia, providing a~     longitudinal and comprehensive perspective to the advantages and disadvantages of this~     technique. The investigators hypothesize that the use of epidural analgesia reduces a~     patient's consumption of morphine or morphine-equivalent in the post-operative period~     following pancreatic resections.~   "
67626|NCT02681783|"~     The presence of Pigment Epithelial Detachments (PEDs) in neovascular Age-related Macular~     Degeneration (nAMD), Central serous chorioretinopathy (CSR) and idiopathic Poplypoidal~     Choroidal Vasculopathy (iPCV) can present a diagnostic challenge in the elderly population;~     despite detailed diagnostic testing to differentiate these three conditions, misdiagnosis and~     mistreatment still occurs. One potential way of differentiating these three conditions might~     be to compare cytokine profiles in nAMD versus CSR versus iPCV. This information may be~     useful in creating a diagnostic aqueous cytokine and hormone profile to differentiate between~     nAMD, CSR and iPCV.~      The primary goal of this study is to compare baseline aqueous cytokine and cortisol levels~     between nAMD, CSR, and iPCV patients and age-matched cataract controls. The secondary~     objective is to assess intra-group changes in visual and anatomical outcomes in nAMD, CSR and~     iPCV patients with PED treated with aflibercept and correlate these changes to baseline~     cytokines. We will not be comparing visual and anatomical changes between groups after~     treatment in this study.~   "
67627|NCT02681770|"~     Following solid organ transplantation, adherence to treatment regime (especially with regard~     to a reliable intake of immunosuppressant medication) is crucial for transplant survival, and~     has an impact on the patients' health and morbidity. Approximately 35 % of graft rejection or~     failure cases in kidney transplant patients are due to insufficient levels of adherence or~     non-adherence to immunosuppressant medication. Adherence is influenced by both individual and~     interpersonal aspects in complex interaction.~      This study aims at investigating individual and dyadic functioning of both patients and their~     spouses following kidney transplantation. Outcome measures of interest are patient's level of~     adherence and both patient and spouse's subjective quality of life.~   "
67628|NCT02681757|"~     The aim of this study is to compare Mepitel Ag to Triple antibiotic ointment impregnated~     Adaptic gauze when used with the soft cast technique to assess overall time to healing, yeast~     infection rate and parents perception of pain level at time of dressing change on a scale of~     1-10. The hypothesis is that Mepitel Ag in combination with the soft cast technique improves~     wound healing in pediatric partial to deep partial thickness hand and foot burns by~     decreasing the length of healing time, decreasing the risk of yeast infection, and decreasing~     pain associated with dressing changes.~   "
67629|NCT02681744|"~     The purpose of this study was to examine the effects of resistance training on sarcopenic~     obesity in older women.~   "
67630|NCT02681731|"~     Through a series of sequential analyses, retrospective database exploration looking for~     linkages and associations between the use of processed electroencephalogram (EEG) and/or~     cerebral saturation monitoring and patient outcomes post-cardiothoracic surgery will be~     explored.~   "
67631|NCT02681718|"~     The purpose of this study is to compare the efficacy of three approaches in diabetes~     management: (1) community health worker (CHW) education; (2) text messaging; and (3) usual~     hospital-based care. The goal is to determine the most cost-effective method of diabetes~     management among an economically-disadvantaged, minority population.~   "
67632|NCT02681705|"~     This phase II trial is studying giving radiation therapy together with combination~     chemotherapy after surgery to see how well it works in treating children with newly diagnosed~     medulloblastoma.~   "
67657|NCT02681380|"~     Empathy is an important skill to learn for medical student. However, learning empathy remain~     difficult. The investigators aim was to assess the efficacy of a specific training, Balint~     like, on the empathy abilities of medical students in the 4th year. The investigators planned~     a randomized controlled trial in 3 universities.~   "
67658|NCT02681367|"~     This is the first study to investigate, whether pregnancy and implantation rates would~     improve in patients with recurrent implantation failure (RIF), if all embryos were to be~     frozen and transferred in a consecutive natural cycle.~   "
87405|NCT02422992|"~     This is a case/control epidemiology study to identify what are the iron-metabolism~     abnormalities in Parkinson's disease (PD) patients, and risk factors relevant to PD~     predisposition.~   "
67633|NCT02681692|"~     Colonoscopy is widely considered as the main choice for patients with suspected colorectal~     disease,and for screening those at high risk of colorectal cancer. However， colonoscope~     examination,especially those unsedated ones for screening,may bring much pain to~     patients,even induce some severe complications such as perforation.Considering the increasing~     need of colonoscopy examination for screening purpose,it has been a problem deserving of~     further study that how to reduce pain and ensure safety during the procedure.Some studies~     suggest that use of Magnetic endoscopic imaging(MEI) during colonoscopy has the potential to~     ease patient discomfort and reduce complications.Theoretically,the MEI could accurately~     depict the position of the scope in three dimensions and help avoid forcefully feeding the~     colonoscope through loops of vulnerable bowel,thus alleviating patient pain and promoting~     procedure safety.However,the problem whether MEI system could help reduce patient pain during~     procedure effectively，especially in inexperienced colonoscopists，still remains controversial~     for researchers,and no study has been designed to test the hypothesis that MEI may help~     decrease the risk of some complications,such as colon perforation.In this study we aim to~     evaluate the he efficacy of magnetic scope navigation on patient pain during unsedated~     colonoscopy；In addition，we try to construct a simple colon force measurement device ,and by~     using this device to observe the variation of force exerted on colon loop ,we expect to find~     the potential mechanism of pain-alleviation and explore the possible effect of complication~     reduction during colonoscopy under the influence of MEI system.~   "
67634|NCT02681679|"~     Since a new generation of femtosecond lasers became available for cataract surgery in 2009,~     the use of this image-guided system has provided several benefits, including a reduction in~     phacoemulsification energy by prefragmentation of the crystalline lens, and the potential~     advantages of more precise corneal incisions and capsulotomy formation. However, as with any~     new surgical technique, femtosecond laser cataract surgery also has potential complications.~     Intraoperative miosis is one of the most common intraoperative complications of femtosecond~     laser-assisted cataract surgery, with a reported prevalence ranging from 9.5 to 32.0%.8~     Significant pupillary constriction necessitates the removal of the anterior capsule flap,~     fragmented nucleus and remaining cortex, which is potentially associated with a higher rate~     of surgery-related complications.~   "
67635|NCT02681666|"~     This pilot study will be a randomized parallel trial comparing Mindfulness-Based Irritable~     Bowel Syndrome Eating Awareness Training done over an 8 week period to a standard low~     Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols diet.~   "
67636|NCT02681653|"~     Sepsis is a common, expensive, frequently fatal and highly complex inflammatory syndrome~     wherein multiple cellular and humoral pathways are involved. Since it's a multifactorial~     syndrome merely blocking one of the various inflammatory pathways may not suffice to provide~     effective treatment and this may partly explain why most of the adjunctive therapies~     developed for severe sepsis have yielded disappointing results in rigorous clinical trials.~     Statins have varied pleiotropic effects on the inflammatory mediators and there addition to~     the current adjuvant therapies in septic shock may help in reduction of mortality. The~     present trial aims to study survival benefit and changes in bio-marker levels in septic~     shock.~      Adult patients (>=18 years) in septic shock and admitted to ICU will be included in the~     study. Patients will be randomized as per computer generated random number into the Drug~     (Atorvastatin, 40 mg) or matched placebo group. Drug or placebo will be given to selected~     patient via nasogastric tube for 7 days. Bio markers (Il-6, TNF-alpha) estimated during the~     trial week (Days 1, 4, and 7). All clinical and study personnel and patients remained blinded~     to the study group assignment throughout the trial.~   "
67637|NCT02681640|"~     The sensitivity and specificity of uPAR PET/CT for preoperative detection of lymph node~     metastases in breast cancer.~   "
67638|NCT02681627|"~     There is increasing amount of evidence which suggests that miscarriage is related to a~     primary endometrial problem. Recent cochrane meta-analysis (March 2015) has proven that~     endometrial scratch improves live birth in women who underwent IVF.~      The aim of the study is to find out if scratch of the endometrium prevents recurrent~     miscarriage.~   "
67639|NCT02681614|"~     This clinical research study tests the Uronav system. Patients with prostate cancer will be~     asked to take part in this study.~      Uronav system is an investigational device that is used on this study to help place markers~     in the patient. These are called fiducial markers and they are placed in the patient to help~     plan radiation treatment. Radiation therapy treatment will be planned by the treating~     physician and will not be experimental or part of this research study.~      This study will also test the similarities and differences of biopsy tissue structures and~     the findings from the intraprostatic MRI (internally guided MRI).~   "
67640|NCT02681601|"~     There are few well-designed studies evaluating the effect of nutrition support in patients~     with cancer cachexia. The aim of this study is to examine the effect of dietary prescription~     with and without nutrition supplementation in patients with unresectable pancreatic cancer on~     body weight, body composition, total calorie intake, quality of life and blood inflammatory~     markers.~   "
67641|NCT02681588|"~     This was a prospective bi-centric study, exposed-unexposed. In an effort to better understand~     the potential independent effect of maternal obesity on fetal growth, investigators designed~     a prospective study, comparing fetal growth between normal weight (18.5 ≤ BMI < 25 kg/m2) or~     obese pregnant women (BMI ≥ 30 kg/m2), while maternal diabetes and hyperglycaemia was~     screened and treated throughout pregnancy.~   "
67642|NCT02681575|"~     The purpose of this study is to examine the initial efficacy of a psycho-social,~     metacognitive-functional intervention for Adults (Cog-Fun - A) with Attention Deficit~     Hyperactivity Disorder (ADHD).~      It is hypothesized that participants in the Cog-Fun - A intervention will demonstrate~     improvements in measures of executive functioning, occupational performance and quality of~     life.~   "
67659|NCT02681354|"~     Mild cognitive impairment (MCI) is accompanied by gait and balance problems while dual~     tasking. During a 6 to 8 weeks training with the BioRescue (virtual reality),~     institutionalized elderly people with MCI will relearn dual tasks in combination with~     balance. Afterwards, the transferring effect on gait in general, balance and cognition will~     be examined.~   "
67660|NCT02681341|"~     The primary objective of this study is to confirm that properties of CardioCel provide~     operative benefit to surgeons when compared to Dacron, CorMatrix, and all other bovine~     pericardium not treated with proprietary ADAPT engineering.~   "
67643|NCT02681562|"~     Treatment selection for breast cancer is still largely empiric and guided by large randomized~     clinical trials on populations of patients. This approach is inadequate for the selection of~     individualized chemotherapy regimens. Estimates of benefits for individuals are~     extrapolations from the effects seen in these large trials, and do not necessarily apply to~     individual patients. The revolution in genomics promises to transform oncology care. By~     better defining cancer subtypes, a better understanding of breast cancer biology should help~     to guide treatment.~      The up-front phase we have decide to adopt play a pivotal role as it is useful for testing a~     targeted therapeutic drug such as olaparib wich also requires development of new biomarkers~     which may be useful for future studies. With this approach it could be possible to~     demonstrate drug target or biomarker effect in clinical setting and models the relationship~     between the pharmacodynamics and the pharmacokinetics. Additional benefits of this approach~     include the following:~        -  It could facilitate rational drug selection, identify therapeutic failures early, and~          compress timelines for anticancer drug development.~        -  It could provide initial rationale and guiding principles for further drug development~          based on studies in humans (rather than xenografts, where tissues of one species are~          transplanted to another species).~        -  As it focuses on extensively characterizing how a drug works and whether it hits its~          intended target (including molecular imaging studies) in a limited number of patients it~          could yield results that would optimally inform and expedite the subsequent development~          of molecularly-targeted agents~   "
67644|NCT02681549|"~     The purpose of this phase 2 trial is to study the activity of pembrolizumab in combination~     with bevacizumab in patients with untreated brain metastases from melanoma or NSCLC to~     determine activity and safety of the drug combination. Furthermore, in patients who undergo~     resection of biopsy of a brain metastasis, we will evaluate biomarkers predictive of~     treatment benefit, and will also conduct correlative biomarker studies on extra-cerebral~     specimens in all patients in whom a systemic biopsy is feasible or in archival tumor tissue~     when available.~      A total of 53 eligible patients will be enrolled on this trial (20 with melanoma and 33 with~     NSCLC). Individual cohorts of the study can be stopped if insufficient activity is observed~     in the first stage of that cohort. The study will accrue for approximately 24 months, and~     will be open for approximately 12 additional months as patients on study are being followed.~   "
67645|NCT02681536|"~     The study is performed to compare the outcomes of two stimulation protocols, the minidose~     long protocol versus the microdose flare protocol in poor responders undergoing IVF/ICSI.~   "
67646|NCT02681523|"~     A single centre, single arm phase II study of alternating eribulin and hormonal therapy in 12~     patients with locally advanced or metastatic breast cancer who have received at least one~     hormonal therapy and at least one chemotherapy in the metastatic setting.~   "
67647|NCT02681510|"~     This study will focus on enhancing future smoking cessation treatment effectiveness by~     piloting a potentially more powerful combination of three FDA-approved pharmacotherapies:~     varenicline plus combination of two types of nicotine replacement therapy (NRT) treatment~     (nicotine lozenge and nicotine patch). Data from this pilot study will help inform the design~     of future studies that would use this combination treatment as a cessation tool within the~     chronic care arsenal of treatments.~   "
67648|NCT02681497|"~     This study is a retrospective chart review study aiming to assess the characteristics and~     health outcomes of patients with type 2 diabetes treated with canagliflozin when used in~     addition to insulin therapy. Furthermore, the project aims to establish an EMR-based cohort~     of patients with type 2 diabetes mellitus (T2DM) treated with canagliflozin to allow for~     future longitudinal studies that investigate outcomes over a longer follow-up period, and~     whether canagliflozin (when used in addition to insulin therapy) has an impact on~     diabetes-related healthcare costs.~   "
67649|NCT02681484|"~     Anthroposophic speech therapy (ATS) has been shown to positively influence heart rate~     variability (HRV) and heart rate - respiration coordination in healthy volunteers. This study~     was performed to learn more about such improvements and possible alteration in baroreflex~     sensitivity (BRS) in hypertensive patients, which characteristically differ in those~     regulatory parameters from normotensive patients~   "
67650|NCT02681471|"~     Aim of this prospective clinical study was to compare two different surgical techniques and~     used solutions on serum electrolytes, bleeding and Transurethral Resection of Prostate (TURP)~     syndrome undergoing TURP.~      Fifty-three patients scheduled for elective TURP were enrolled in this prospective clinical~     study. Patients were included one of two groups (Group Monopolar and Group Bipolar).~   "
67651|NCT02681458|"~     The purpose of this study was about survey of prevalence of fungal infections among drug~     users referring to methadone wards of Hospitals in northeast region of Iran~   "
67652|NCT02681445|"~     The purpose of this pilot study is to evaluate the sensitivity and specificity of a~     nanotube-based point-of-care breath-based tuberculosis screening test as compared to the~     current standards of care including sputum microscopy, sputum culture, chest X-ray, and~     GeneXpert (MTB/RIF).~      The primary objective is to determine an initial estimate of the sensitivity and specificity~     of a nano-tube based point-of-care test for the diagnosis and screening of active pulmonary~     tuberculosis.~      Secondary objectives include the collection of user data to test and further develop the~     screening platform based on end-user feedback.~   "
67653|NCT02681432|"~     Randomized clinical trial to asses the efficacy of closed abdomen hyperthermia~     intraperitoneal chemotherapy with paclitaxel in ovarian cancer.~   "
67654|NCT02681419|"~     This study evaluates two different methods of controlling intraocular pressure in nonvalved~     aqueous tube shunts immediately after implantation; needle fenestrations or a suture wick.~   "
67655|NCT02681406|"~     Investigators will recruit 280 alcohol dependent patients in treatment programs in the~     Philadelphia area to test the efficacy and cost efficiency of a smartphone based application~     for treating alcohol addiction (ACHESS) with telephone monitoring and counseling (TMAC).~     Participation in the study lasts for 18 months with research visits at baseline, 3 months, 6~     months, 9 months, 12 months, and 18 months. The intervention lasts 12 months.~   "
67661|NCT02681328|"~     The purpose of this study is to compare the performance of Afirma GSC and ThyroSeq v.3 in~     indeterminate thyroid nodules to determine which test can allow more patients to avoid~     unnecessary surgery and preserve quality of life. In the initial phase of this study, the~     performance of Afirma GEC and ThyroSeq v.2 were compared.~   "
67663|NCT02681302|"~     The goal of this study is to determine the safety and clinical effect of combined checkpoint~     inhibition administered after autologous hematopoietic stem cell transplantation in each of~     six clinical cohorts of high risk and recurrent disease. In addition to assessing the~     incidence and severity of adverse events and rates of complete response and progression free~     survival, investigators intend to monitor immune reconstitution, phenotype and TCR repertoire~     throughout treatment and at the time of disease progression. Investigators will also analyze~     the gut microbiome prior to conditioning, throughout treatment, post-transplant and at time~     of relapse.~   "
67664|NCT02681289|"~     Early physiotherapy reduces neuromotor problems in at-risk infants. This study was planned to~     compare the effects of an early goal-directed neuromotor physiotherapy (GDNT) application~     between preterm and term at-risk infants.~   "
67665|NCT02681276|"~     Aim: To compare the clinical antimicrobial and adverse effects of irrigation with Sodium~     Hypochlorite (NaOCl) 0.5% versus NaOCl 3% during root canal treatment.~      Methodology: Consecutive patients referred to a specialist clinic of endodontics are randomly~     assigned to have the root canal treatment performed with a concomitant irrigation either with~     a buffered 0.5 % NaOCl (Dakin's solution) or 3 % NaOCl. Teeth with vital or necrotic pulps~     and retreatment cases were included. Root canal treatment procedures varied but followed the~     routines of the Specialist Clinic of Endodontics, Public Dental Health, Gothenburg, Sweden.~     Immediately before the root canal filling a microbial sample is taken from the operative~     field and the root canal. The bacterial samples were processed at the laboratory as outlined~     by Möller (1966). After each visit each patient was instructed to fill in a questionnaire and~     assess his or her post-operative pain on a visual analogue scale (VAS), with endpoints 0= no~     pain and 10= worst imaginable pain, for seven consecutive days. The Fischer's exact test~     was used for statistical analyses of the differences in outcome between the groups.~   "
67666|NCT02681263|"~     The present study aims at demonstrating the efficacy of temocillin in the treatment of UTI~     requiring parenteral therapy due to a confirmed ESBL producing or AmpC hyperproducing~     Enterobacteriaceae, resistant to quinolones and Bactrim® in France. In addition, this study~     will describe and support the use of high dose (6g/day) of temocillin which could be of~     interest for the treatment urinary tract infection due to multi-resistant bacteria having~     high MIC (up to 32 mg/L). The investigators will also evaluate the tolerance of the drug by~     monitoring the adverse event and the incidence of eventual Clostridium difficile associated~     infection.~   "
67667|NCT02681250|"~     A Randomized controlled Clinical trial including 96 patients in which aim is to investigate~     the clinical outcome of dental implants in titanium-zirconium alloy compared to traditional~     titan-4 implants. The hypothesis is set to no difference in the clinical outcome for the two~     types of implants.~   "
67668|NCT02681237|"~     This is a proof of concept study (a study to initially assess the benefit a new drug~     indication) of the combination of two investigational drugs cediranib and olaparib in~     patients with ovarian cancer whose cancer worsened despite previously receiving a poly~     (ADP-ribose) polymerase (PARP) inhibitor (such as olaparib).~      The purpose of this study is to find out whether taking cediranib and olaparib at the same~     time will be able to stop tumors from growing further or shrink it.~      Cediranib works by blocking (inhibiting) several specific proteins in cancer cells called the~     vascular endothelial growth factor (VEGF) receptors. These proteins are important in the~     formation of blood vessels to the tumor. It is believed that many tumors survive because the~     blood vessels on the tumors bring oxygen and nutrients to the cancer cells which enable them~     to grow. If the formation of the blood vessels is blocked, the tumor cells may die.~      Olaparib, works by blocking a protein called poly [adenosine diphosphate-ribose] polymerase~     (PARP). PARP is an important protein which tries to fix damaged deoxyribonucleic acid (DNA,~     molecules that contain important instructions for the development of cells). Many cancers are~     thought to develop from damaged DNA. By blocking PARP from fixing damaged DNA, the tumor~     cells may die.~      Adding cediranib to olaparib, and therefore blocking several different mechanisms for cancer~     growth, may stop tumor growth.~   "
67669|NCT02681224|"~     A single site, double-blind, randomized, placebo-controlled, clinical study comparing the~     difference between a novel healing gel and a placebo gel on post laser-resurfacing chests.~   "
67670|NCT02681211|"~     Patients with migraine headache will be offered the opportunity to participate in this~     randomized study evaluating auricular acupuncture versus standard treatment for migraine~     headaches for patients in the pediatric emergency department (ED).~   "
67671|NCT02681198|"~     The purpose of this study is to determine the pharmacokinetics, safety and tolerability of~     lofexidine HCl in the presence of paroxetine in healthy adults.~   "
67672|NCT02681185|"~     The study's goal is to promote accessible and cost-effective diabetes care through electronic~     means. Underserved populations including rural areas do not have diabetes specialists.~     Previous study data has shown the effectiveness of Internet communication in lowering a~     patient's Hemoglobin A1C, a measure of blood sugars, closer to the target number. The~     investigators thus wish to test the effectiveness of diabetes care provided by virtual means,~     including virtual consultations, online monitoring of blood sugars, diabetes education via~     web-based videos, and support/advice provided through phone or email by an Endocrinologist.~     The goal is to test if virtual care is a viable means to extend care for diabetes to~     underserved populations.~   "
67673|NCT02681172|"~     This phase 4 study will explore, in the context of the present French clinical practice, the~     impact of florbetaben 18F (FBB) in patients evaluated for AD who require a biomarker for~     etiologic determination of the cognitive and functional impairment, but in whom:~        1. lumbar puncture was not feasible for medical conditions~        2. results of cerebrospinal fluid (CSF) analysis were considered ambiguous by treating~          physicians~        3. lumbar puncture was refused by the patient~   "
67674|NCT02681159|"~     Critical incidents in anesthesia is one of the most valuable methods to assess the safety of~     anesthesia practice among different types of patients. Most of the studies in this regards~     are retrospective with many drawbacks and pitfalls like absence of information in the records~     of the patients.~      In the investigators' study, the investigators will follow the critical incidents among~     patients who underwent surgery under anesthesia whether regional or general over the next two~     years from 2016 to 2018, by examining the patients records from the hospital database and~     recording the events that occur to the patients.~   "
67675|NCT02681146|"~     A stepped-wedge cluster design will be used, with the duration of the trial being 50 weeks.~     The 'stepped-wedge ' cluster randomised trial is a form of cross-over design with~     unidirectional cross-over ( from control to experimental ) but with randomisation of when~     each cluster undertakes this transition. In the stepped-wedge design, there is a staggered~     roll-out of the intervention, where the time and hence the sequence of units (clusters) that~     will start the intervention at each period is determined by random allocation.~      The randomisation occurs before the start of the trial. All clusters start the trial in a~     control phase with no intervention being delivered at any site, then sequentially cross over~     from the control group to the intervention group, until all sites are receiving the~     intervention. Outcomes are measured on the study participants in all clusters at every time~     period, hence measurement of outcomes takes place at each step in the wedge; each cluster~     provides data points in the control and intervention conditions allowing each site to act as~     its own control.~   "
67676|NCT02681133|"~     The primary purpose is to evaluate the level of physical activity in patients with knee~     osteoarthritis in a spa treatment and doing epidemiological study about this patient.~   "
67677|NCT02681120|"~     This is a pilot, non-randomized, single institution, observational study investigating the~     effect of dramatic weight loss secondary to bariatric surgery on biomarkers of breast cancer~     in tissue and blood as well as on imaging in women at elevated risk for breast cancer. Twelve~     months after bariatric surgery, 50% of excess weight is generally expected. Eligible women at~     elevated risk for breast cancer who are already planning to undergo bariatric surgery will be~     consented to undergo imaging (MRI and mammogram), breast tissue biopsy, and fasting blood~     draw prior to bariatric surgery, approximately 14 days after bariatric surgery, and~     approximately 1 year after bariatric surgery.~      In parallel we will also be assessing 40 normal breast tissue specimens as well as blood~     samples from the Komen Tissue Bank (elevated risk but normal BMI) to establish a normal BMI,~     elevated risk control group for our study. The KTB samples will be matched for general risk~     of breast cancer (>20%), age, race and menopausal status.~   "
67678|NCT02681107|"~     This study will test the safety of partial breast RT using 27Gy in 5 daily fractions which is~     expected to be equally tolerated as standard whole breast irradiation (WBI) based on~     radiobiologic modeling of the fibrosis response of normal tissues but be more convenient and~     less costly than 3-6 weeks of standard WBI. 274 women will be treated. Rates of fibrosis and~     cosmesis at 2 years will be compared to data already collected using standard WBI in the~     Canadian RAPID trial.~   "
67679|NCT02681094|"~     The aim of this study is to evaluate safety and efficacy of therapy with saxagliptin 5mg~     co-administered with dapagliflozin 5mg, compared to therapy with saxagliptin 5mg or~     dapagliflozin 5mg in patients who are inadequately controlled on ≥1500mg/day of metformin~     monotherapy.~   "
67680|NCT02681081|"~     The purpose of the study is to identify non-invasive strategies that will optimize the~     neurobiological environment and improve learning and memory in the treatment of chronic pain.~     The overall aims of the current proposal are to determine if food restriction and/or glucose~     administration in conjunction with a relaxation/guided imagery exercise will result in~     neurophysiological changes and functional improvements compared to the relaxation/guided~     imagery exercise alone.~   "
67681|NCT02681068|"~     The registry collects cases of patients received fecal microbiota transplantation (FMT) due~     to Clostridium difficile associated diarrhea (CDAD). The main objective of this study is to~     analyze the safety and effectiveness of FMT. Furthermore, data analysis will be used to~     implement a standardization of FMT in German hospitals and improve patient outcome.~     Therefore, a detailed description of completions of FMT are documented on our web-based~     survey platform www.ClinicalSurveys.net.~   "
67682|NCT02681055|"~     This is a multi-center, proof-of-principle, open-label study designed to evaluate the~     efficacy, safety, and tolerability of MN-001 in non-alcoholic steatohepatitis (NASH) and~     Non-Alcoholic Fatty Liver Disease (NAFLD) subjects with hypertriglyceridemia.~   "
67683|NCT02681042|"~     The study cohort will consist of up to 50 patients who are candidates for Left Atrial~     Appendage (LAA) closure in whom oral anticoagulation is contraindicated.~      Subjects evaluated for left atrial appendage closure will be screened for inclusion and~     consented prior to their procedure. If the anatomy is favorable for placement of the Lariat®~     device, the procedure will be performed at one of the participating centers. If anatomy is~     not favorable, the patient will be excluded from the study and managed using best care~     practices by his or her physician.~   "
67684|NCT02681029|"~     Recent improvements in cell culture systems have led to a shift in in vitro fertilization~     (IVF) practice from early cleavage stage embryo transfer (ET) to blastocyst transfer.~     Blastocyst culture and transfer could theoretically provide better synchronization between~     the embryo and the uterine endometrium. The purpose of this study is comparing pregnancy~     rates and implantation rate following transfer of thawed cleavage embryos and blastocysts~     cultured from thawed cleavage embryos.~   "
67685|NCT02681016|"~     The aim of the study is to evaluate the efficacy and safety of sirolimus-eluting coronary~     stent Calypso (Angioline, Russia) in comparison with everolimus-eluting coronary stent~     Xience (Abbott Vascular, USA)~   "
67686|NCT02680990|"~     This is a pilot study to evaluate the feasibility of, adherence to, and early efficacy of~     Band Together, a strength-training and walking program (intervention arm) vs. education on~     the benefits of exercise (control arm) in patients with aggressive gastrointestinal (GI)~     malignancies (gastric, gastroesophageal, and pancreatic cancer) undergoing neoadjuvant~     therapy.~   "
67687|NCT02680977|"~     In low-income areas worldwide, most patients with Parkinson's disease (PD) cannot afford~     long-term Levodopa therapy. A potential therapeutic option for them is the use of a legume~     called Mucuna Pruriens var. Utilis (MP), which has seeds with a high levodopa content (5-6%)~     and grows in all tropical areas of the world. MP powder is very cheap (total annual cost for~     a PD patient: 10-15 US $). The aim of this study is to assess efficacy and tolerability of~     acute and chronic use of MP compared to standard Levodopa therapy.~      The primary objective of this study is to investigate efficacy of acute levodopa challenge~     using MP in comparison to levodopa with a Dopa Decarboxylase Inhibitor (LD+DDCI) and without~     (LD-DDCI) and placebo.~      The secondary objectives are to investigate safety of acute intake of MP as well as efficacy~     and safety of chronic intake of MP over a 8-week period in comparison to usual LD+DDCI home~     therapy.~   "
67689|NCT02680938|"~     The third stage is the interval between delivery of the infant and delivery of the placenta.~     This stage averages 10 minutes and is considered prolonged if it lasts longer than 30~     minutes, placental separation occurs as a result of continued uterine contractions, continued~     contractions control blood loss by compression of spiral arteries and also result in~     migration of the placenta into the lower uterine segment and then through the cervix.~      The intra-umbilical vein injection of 10 IU of oxytocin is recommended as a first line of~     treatment for retained placenta. Despite this recommendation, the method has yet to make its~     way into routine practice, probably because of the lack of a large substantive randomized~     controlled trial, and lingering doubts over which uterotonic to use and at what dosage.~      The purpose of this study is to evaluate the effect of intraumbilical vein injection of~     oxytocin on reducing the duration of the third stage of labor and the need for manual~     delivery of placenta, ,in addition to reduce blood loss during third and fourth stage of~     labor and decrease incidence of rtained placenta in comparison with inraumblical injection of~     normal saline.~      This is a prospective randomized control trial conducted at Ain Shams University Maternity~     Hospital. This study included 240 term pregnant women in labor admitted to the labor ward,~     They were divided into Two groups :~      Group (A):~      The experimental group, 10 units of oxytocin will be injected into the umbilical vein at the~     most proximal site to the placenta after clamping and cutting of the umbilical cord.~      Group (B):~      The control group, 1 mL normal saline will be injected into the umbilical vein at the most~     proximal site to the placenta after clamping and cutting of the umbilical cord.~   "
67690|NCT02680925|"~     The investigator will evaluate the influence of lung protective ventilation on postoperative~     clinical outcome in pediatric patients. The hypothesis is that application of low tidal~     volume, intermittent alveolar recruitment and adequate positive end-expiratory pressure~     (PEEP) would be more beneficial than conventional ventilation in children.~   "
67691|NCT02680912|"~     This is a two-armed randomised controlled pilot study that investigates the component~     efficacy of moxibustion for osteoarthritis of the knee. Participants will be randomised to~     receive either warm needle acupuncture or needle acupuncture. Participants and acupuncturists~     will be blinded to group allocation. The primary and secondary outcome measures are WOMAC and~     SF36 respectively. Qualitative interviews will be used to gather information on the patients'~     experiences and perceptions of the trial and the treatment provided.~      It is hypothesised that warm needle acupuncture will lead to a greater reduction in clinical~     signs and symptoms than needle acupuncture.~   "
67692|NCT02680899|"~     The study herein seeks to determine whether students undergoing InSciEd Out curriculum in~     mental health and addiction (called My Mind, My Body) experience changes in their mental~     health-related knowledge, attitudes, and help-seeking behavioral intentions. The research~     group hypothesizes that students undergoing InSciEd Out mental health and addiction~     curriculum will exhibit pre-post increases in mental health literacy, decreases in mental~     health stigmatization, and increases in mental health help-seeking behavioral intentions.~   "
67693|NCT02680886|"~     The aim of this study is to show that the performance of Novosyn® Quick suture material is~     comparable with other suture material used for skin closure. In order to show that, various~     safety and efficacy parameters have been selected. The outcome regarding these parameters~     will be evaluated by a quantitative summary of the available clinical data from the~     literature.~   "
67694|NCT02680873|"~     the investigator modified the Sanator's operation by performing a loop rather than Roux-en-Y~     bipartition reconstruction and the investigator are reporting the first clinical results of~     the outcomes of SASI bypass as a mode of functional restrictive and neuroendocrine modulation~     therapeutic option for obese type 2 diabetes mellituspatients.~   "
67695|NCT02680847|"~     Safety and pharmacokinetics of an abuse-deterrent, extended-release formulation of oxycodone~     hydrochloride with a sequestered naltrexone core in children 7-17 with moderate-severe pain.~   "
67696|NCT02680834|"~     The purpose of the study is to test non-inferiority of chronic Venous Leg Ulcer (VLU) area~     closure at 16 weeks with a dual action pneumatic compression device compared to multi-layer~     bandaging.~   "
67697|NCT02680821|"~     Patients with combined Anterolateral ligament (ALL) reconstruction- Anterior cruciate~     ligament (ACL) revision will have a better rotational knee stability and therefore better~     patient reported outcome measure (PROM) scores compared to patients, who have ACL revision~     surgery without ALL reconstruction.~   "
67698|NCT02680808|"~     Open label evaluation of potential interaction of F901318 with cytochrome P450 3A4 using~     midazolam as a probe. Twenty healthy male subjects will participate~   "
67699|NCT02680795|"~     This is a Phase 1, open-label, nonrandomized study to determine the PK profiles of belinostat~     in patients with relapsed/refractory solid tumors or hematological malignancies who have~     heterozygous and homozygous UGT1A1*28 genotypes and wild-type UGT1A1 gene. Enrolled patients~     will be assigned to 1 of 3 cohorts (A, B, or C) based on their UGT1A1 genotype~   "
67700|NCT02680782|"~     This study will evaluate the safety, tolerability and pharmacokinetics of X4P-001~     administered as 200 mg twice daily compared with 400 mg once daily.~      This study will also assess the pharmacodynamic effects of X4P-001 administered as 200 mg~     twice daily compared with 400 mg once daily on levels of circulating white blood cells (total~     and by cell type).~   "
67701|NCT02680769|"~     Magnesium (Mg) is involved in several pathways that could be affected in chronic obstructive~     pulmonary diseases (COPDs), namely in the contractility and excitability of neuro-muscolar~     endothelial cells and low-grade inflammation, a typical state of COPD. In this sense, several~     randomized controlled trials (RCTs) confirmed a positive role of Mg in asthma since~     long-period oral supplementation of Mg leads to a clinical and spirometric improvement.~      Subjects with COPD seem to have a reduced bioavailability of Mg probably due to the use of~     drugs that may increase Mg losses (e.g. beta-agonists and cortisones), to a reduced dietary~     Mg intake, and heavy smoking. A recent study showed that the administration of endovenous or~     aerosol Mg sulphate with beta-agonists acutely improve maximum expiratory flow during COPD~     relapses as well as the prolonged treatment with endovenous sulphate Mg led to a reduction in~     pulmonary hyperinflation and increase in muscles involved in respiration, with a consequent~     clinical and instrumental improvement.~      These evidences suggest that a chronic supplementation with Mg could improve COPD in clinical~     and instrumental parameters, but, at the best of our knowledge, no study was available in~     this sense.~   "
67703|NCT02680743|"~     Objective:~      Congenital cytomegalovirus (cCMV) is the most common non-genetic cause of pediatric~     sensorineural hearing loss (SNHL) and an important cause of neurodevelopmental delay. Infants~     with cCMV can be symptomatic, asymptomatic, or asymptomatic except for hearing loss.~     Symptomatic infants may be more readily identified and quickly referred for intervention~     because they may present with classic common clinical findings, but the majority of infants~     (85-90%) with cCMV are asymptomatic at birth and do not have the classic clinical,~     laboratory, or radiologic findings and therefore often have delayed identification and~     intervention. Often, these otherwise asymptomatic infants with cCMV may have early congenital~     hearing loss and therefore fail the newborn hearing screen but because they are not~     specifically identified as having cCMV there is a delay in seeking further audiology exam and~     treatment of the CMV infection.~      The overall objective of this proposed research is to investigate how testing newborns for~     congenital cytomegalovirus infection (cCMV) after a failed newborn hearing screens can~     improve early identification of cCMV infection and therefore reduce the delay in referral of~     the newborn to appropriate specialists for intervention.~      Eligibility Criteria:~      Eligible participants will include newborns in the NBN or NICU who are less than 14 days of~     life who fail the standard hearing screening.~      Interventions and Evaluations Saliva samples will be obtained from participating infants with~     a mouth swab according to an established protocol. The saliva will then be tested for CMV by~     qualitative polymerase chain reaction by ARUP Laboratories. Infants who test positive for CMV~     infection will then be referred for repeat audiology exam to confirm hearing loss and to~     Pediatric Infectious Diseases for evaluation and treatment if necessary. Parents or guardians~     of infants who test positive for cCMV will receive counseling on the importance of following~     up with these specialists. The primary outcomes measured will be cCMV prevalence data and~     time to referral and intervention.~      Follow up:~      Follow-up will be as clinically indicated and determined by the infant's primary care~     provider, pediatric infectious disease physician, and audiologist. It will not be determined~     by the study, referral to these services will be the study endpoint.~   "
67704|NCT02680730|"~     Purpose: A research project will be conducted at the ADD (Attention Deficit Disorder)~     Centre and Biofeedback Institute of Toronto to evaluate the feasibility of the Listening~     Project Protocol (LPP) intervention in individuals with difficulties with autonomic and/or~     behavioral regulation. The LPP is designed as a neural exercise to reduce auditory~     hypersensitivities, to improve auditory processing of speech, and to improve behavioral state~     regulation. These improvements should translate into increase feelings of safety and~     calmness, thereby promoting improvement in social behavior.~      Participants: 30 participants, males and females between ages 7-55 years, will be recruited~     for the study. Participants will be patients at the ADD Centre and Biofeedback Institute of~     Toronto.~      Procedures: Participants will be divided into 1 of 2 groups (1:1 ratio). Both groups will~     have a pre-intervention assessment #2, intervention, 1 week post intervention assessment and~     1 month post intervention assessment. Group 2 will have an additional pre-intervention~     assessment session #1 (1 week previous to pre-intervention assessment #2) to assess the~     stability of the measures prior to starting the intervention. Pre-, post-, and 1 month~     followup assessment will include parent and/or self-report questionnaires, and measures of~     the individual's auditory processing (SCAN), affect recognition (DARE Dynamic Affect~     Recognition Evaluation), heart rate, prosody, RSA respiratory sinus arrhythmia (derived~     from non-invasive ECG recording), and middle ear transfer function (MESAS - Middle Ear~     Sound Absorption System).~   "
67705|NCT02680717|"~     This is a study designed to evaluate the comparative effectiveness of topical medications for~     the treatment of circumscribed morphea.~   "
67706|NCT02680704|"~     The purpose of this study is to collect physiologic data from patients with severe brain~     injury who require mechanical ventilation in order to describe the impact of ventilation,~     specifically positive end expiratory pressure (PEEP), on intracranial pressure (ICP).~   "
67707|NCT02680691|"~     The Effect of Robot Assisted Gait Training in Patients With Infratentorial Stroke~   "
67708|NCT02680678|"~     Prevention of postspinal hypotension after spinal anesthesia for caesarian section by use of~     preoperative or intraoperative volume replacement. The comparison of crystalloid and colloid~     infusions and their timing via perfusion index and plethysmographic variability index.~   "
67709|NCT02680665|"~     This Study is intended to evaluate the safety and effectiveness of Ameparomo Capsules 250 mg~     under actual medical practice.~   "
67710|NCT02680652|"~     This is an observational, case--control study with a single blood draw among two cohorts,~     patients with CVID and healthy controls. Samples will be analyzed by cytometry (CyTOF) to~     simultaneously examine the major signaling pathways of all circulating innate and adaptive~     immune cell types as well as whole exome sequencing. The goal is to improve our general~     understanding of the human immune response to infections and the diagnosis of CVID.~   "
67711|NCT02680639|"~     Chronic Obstructive Pulmonary Disease (COPD) is a major cause of chronic morbidity and~     mortality throughout the world, being the fourth leading cause of death in the world.~      This study is designed to detect COPD participants with Expiratory Flow Limitation. EFL~     occurs when the airways become compressed which usually results when a pressure outside the~     airway exceeds the pressure inside the airway.~      Participants will undergo study eligibility procedures at visit 1. At visit 2 participants~     will undergo a baseline auto-EPAP (Expiratory Positive Airway Pressure) measurement. Then the~     order will be randomized to three different treatment methods. Between each treatment there~     will be at least a 10 minute washout period in order for CO2 to stabilize and return to~     baseline.~   "
67712|NCT02680626|"~     Pain control after surgery is important for patient well-being and recovery. We are~     interested in determining whether we can improve the duration of action of a local anesthetic~     procedure (transversus abdominis plane block, or TAP block) by adding magnesium sulfate to~     local anesthetics given to patients after total abdominal hysterectomy with or without~     salpingo-oophorectomy.~   "
67713|NCT02680613|"~     The purpose of this study is to determine whether motivational text messages and/or travel~     vouchers are effective in increasing cervical cancer screening rates in urban and rural~     regions of Northern Tanzania.~   "
67714|NCT02680600|"~     Several population pharmacokinetic (PK) models for cefepime in critically ill patients have~     been described, all indicating that variability in renal clearance is the main determinant of~     observed variability in exposure. The main objective of this study was hence to determine~     which renal marker best predicts cefepime clearance.~   "
67715|NCT02680587|"~     Men with oligometastatic prostate cancer lesions will be randomized (1:2) to observation~     versus SBRT. The study will NOT be blinded. Within three weeks of the initial treatment~     planning, SBRT (1-5 fractions) will be administered.~   "
67716|NCT02680574|"~     A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance~     treatment of anemia in subjects with NDD-CKD~   "
67717|NCT02680561|"~     The purpose of the study is to characterize the pharmacokinetic profiles of fluticasone~     propionate and/or salmeterol when delivered as a single oral inhalation dose of Fp MDPI and~     FS MDPI.~   "
67718|NCT02680548|"~     Injections of local anesthetics (freezing) and steroids are often performed around injured~     nerves in individuals with nerve injury-related pain. The current standard of medical care is~     to inject a combination of local anesthetics and steroids around injured nerves, but there is~     no proof that this is better than injecting only local anesthetic, or even just sterile salt~     water. There is evidence to believe that injection of local anesthetic (without the steroid)~     can calm the injured nerve, and provide pain relief from a few days up to a few months.~     Injection of sterile salt water also has the potential to provide pain relief by breaking~     scar tissue around the nerve, thereby relieving compression. The aim of this study is to~     compare pain relief and possible adverse effects from these three different treatments for~     foot and ankle nerve pain relief.~      All 30 participants will be recruited over 9 months from the Altum Health clinic at Toronto~     Western Hospital. 10 participants will be randomly assigned to each treatment. Each patient~     will receive 3 injections over 3 weeks or so. Participants will have an in-clinic follow-up~     at 1 month after the last injection, and a phone follow-up 3 months after the last injection.~      This is a small-scale study, and information obtained from this study will help in planning~     and conduct of a larger study with more participants. The larger study will help determine~     the best possible option for injection in patients with nerve-related injury pain.~   "
67719|NCT02680535|"~     To determine the efficacy of using MRI/US fusion imaging technology to direct focal ablation~     of prostate tissue using nanoparticle-directed laser irradiation.~   "
67720|NCT02680522|"~     Introduction: The Parkinson is one of the most common degenerative diseases of the central~     nervous system , mainly characterized by resting tremor , rigidity, akinesia and postural~     instability , also featuring the autonomic modulation of heart rate , which can lead to~     reduced frequency variability heart . Some activities may modify the modulation , including~     rehabilitation using virtual reality. Method: The research is interventional type , quantity~     and prospective, where volunteers were chosen for inclusion and exclusion criteria and~     divided into two groups , Control and Parkinson's, where they underwent 24 sections with~     virtual reality physiotherapy three times a week . Analysis of the autonomic modulation of~     heart rate was performed before and after the rehabilitation program with the frequency meter~     Polar brand. Statistical analysis was performed in 5.2 Biostat program with Shapiro- Wilk~     test to verify the normality , followed by t test to compare the data.~   "
67721|NCT02680509|"~     The goal is to investigate the effect of a single-port R3 sympathicotomy on microvascular~     circulation in the affected fingers. This effect is analysed by performing cooling~     plethysmography and nailfold capillary microscopy bilaterally, following a unilateral,~     single-port thoracoscopic sympathicotomy.~   "
67722|NCT02680496|"~     The primary objective of the study is to investigate the energy consumption,~     cardiorespiratory load and perceived exertion, and how these parameters change, during~     walking with robot-assistance compared to walking on a treadmill and walking overground in~     stroke patients.~      A secondary objective is to investigate whether these changes or differences in energy~     consumption, cardiorespiratory load and perceived exertion during walking with and without~     robot-assistance in stroke patients are related to changes or differences spatiotemporal gait~     characteristics.~   "
67723|NCT02680483|"~     Prospective registry of all new comers with Atrial fibrillation~   "
67724|NCT02680470|"~     Using modern technology, investigators will observe participants taking their TB tablets~     three times per week using a mobile phone, iPod or computer with camera facilities in the~     participants home environment.~   "
67725|NCT02680457|"~     Type 2 diabetes mellitus (T2DM) is characterized by wide fluctuations of glucose. The~     long-acting insulin has showed to improve glycemic variability however the behavior of~     insulin glargine versus insulin degludec is unknown.~   "
67726|NCT02680444|"~     Brief and cost-effective interventions teaching emotion regulation techniques can be feasibly~     applied to promote mental health in University students. The tools of mindfulness (i.e.,~     objective awareness and acceptance) and positive reappraisal (i.e., positive re-evaluation of~     negative events) can mutually benefit one another to promote well-being. The current study~     explored the effects of a randomly-assigned Mindful-Reappraisal intervention (n=36) compared~     to Reappraisal-Only (n=34) and an active control (n=36) on university students' daily affect~     over five days. Time by condition interactions were analyzed with planned contrasts and~     multilevel growth modelling.~   "
67727|NCT02680431|"~     The purpose of this study is to find blood plasma based biomarkers of disease progression in~     neurofibromatosis type 1 (NF1). NF1 is associated with the development of benign cutaneous~     tumors as well as a variety of malignancies. Analysis of plasma DNA and chemical composition~     may provide tools for diagnosis and follow-up of NF1. The hypothesis of the study is that~     NF1-associated tumor burden and malignant transformation of tumors can be detected in plasma.~     To test this hypothesis, Finnish patients with NF1 are recruited and blood sample is taken.~     Blood plasma is separated and analyzed chemically. DNA is then also extracted and quantified.~   "
67728|NCT02680418|"~     To determine the pharmacokinetics of single and multiple doses of FDL169 in healthy female~     subjects.~   "
67729|NCT02680405|"~     Atopic dermatitis is a skin disorder with an itchy, red skin rash. This may be because~     certain proteins are increased in the skin of AD patients. The increased expression of these~     proteins play an important role in the development of AD and may increase the risk for~     persons with AD to get skin infections and allergies.~      There are very few non-invasive ways to diagnose and monitor the development and progression~     of atopic dermatitis. The goal of this study is to develop laboratory tests, done on skin~     samples collected by tapy stripping, that can be used for early detection and monitoring the~     response to treatment for a variety of skin diseases, including atopic dermatitis.~   "
67730|NCT02680392|"~     This randomized, double blind controlled trial is designed to investigate the potential~     benefits of radiofrequency in terms of analgesia and functional outcome, compared to the~     conventional continuous adductor canal block, for patients undergoing total knee arthroplasty~     for osteoarthritis.~   "
67731|NCT02680379|"~     The purpose of this study is to determine whether Lovastatin, Minocycline and the combination~     Lovastatin/Minocycline are effective in treating behavioral symptoms in Fragile X~     individuals.~   "
71092|NCT02636439|"~     The purpose of this study is to examine the effects of weight loss via hypocaloric diet~     (CR)and aerobic exercise (AT) compared to the effects of weight loss via hypocaloric diet~     (CR), aerobic training (AT)and resistance training (RT).~   "
67732|NCT02680366|"~     This study evaluates the addition of collagen scaffold loaded with autologous bone marrow~     mononuclear cells(ABMNC) to Foley catheter balloon after hysteroscopic adhesiolysis in the~     treatment of severe asherman syndrome. Half of participants will receive collagen/ABMNC~     scaffold after hysteroscopic adhesiolysis, while the other half will receive Foley catheter~     balloon.~   "
67733|NCT02680353|"~     To determine the postoperative analgesic efficiency of bilateral superficial plexus block,~     patients are divided into two groups. Study group received bilateral superficial plexus~     block, where control had none. Visual analog scale, opioid consumption and presence of~     nausea-vomiting are recorded.~   "
67734|NCT02680340|"~     The primary purpose of this study is to demonstrate the POLARSTEM™ Ti/HA cumulative femoral~     stem revision rate at 10 years.~      The secondary purpose of this study is to provide 10 years of safety and effectiveness data~     of POLARSTEM™ Ti/HA in terms of radiographic and clinical performance~   "
67735|NCT02680327|"~     This is a prospective epidemiological pilot study to evaluate the feasibility of recruiting~     and retaining patients in a large multicenter study that will audit Advanced Care Planning~     (ACP) practices and satisfaction with End Of Life (EOL) communication and decision-making in~     patients undergoing cardiac surgery using the current validated questionnaires and~     methodology.~   "
67736|NCT02680314|"~     The goal of this study is to determine whether inducing labor with just one dose of~     misoprostol, followed by treatment with oxytocin, will still be effective enough to increase~     the chances of having a successful vaginal delivery as compared to using more than one dose~     of misoprostol, followed by treatment with oxytocin.~   "
67737|NCT02680301|"~     The purpose of this study is to~        1. Compare efficacy of 0.1% triamcinolone containing wet wrap as an ointment or as a cream~          formulation in patients with moderate to severe atopic dermatitis~        2. The relative patient/subject acceptance and adherence will also be compared between the~          two wet wrap types~   "
67738|NCT02680288|"~     This is a randomized, cross-over, single-blind, placebo-controlled, single-center,~     multiple-panel evaluation of the potential for oral lorcaserin to modify cocaine~     self-administration in a laboratory setting. To prevent unauthorized drug use, study~     medications will be administered as participants are confined during overnight stays at the~     Medical Center. Non-treatment-seeking, regular cocaine users will receive oral treatment with~     single doses of placebo, lorcaserin 10 mg (Panel 1), or lorcaserin 20 mg (Panel 2).~     Afterwards, the subjective and reinforcing effects of intravenous cocaine will be measured in~     a laboratory setting.~   "
67739|NCT02680275|"~     This study evaluates the effect of Dead Sea Peloid Gel in the treatment of Chronic~     Endometritis in women with reproductive disorders. Half of participants will receive Dead Sea~     Peloid Gel and antibiotics, while the other half will receive Placebo Gel and antibiotics.~      Patients with reproductive disorders who visited Research Medical Center of Family Health~     Problems and Human Reproduction were recruited.~   "
67740|NCT02680262|"~     The trial will evaluate the effect on participation in organised screening programme of a~     human papilloma virus (HPV) self-sampling kit directly mailed home or mailed on demand~     compared with the standard second reminder for regular screening.~   "
67741|NCT02680249|"~     Three way crossover study to assess the bioavailability of 656 under fed and fasted~     conditions.~   "
67742|NCT02680236|"~     Art therapy offers benefits and support for a range of psychological symptoms caused by~     cancer and its treatments, for example anxiety, stress, depression, sleeplessness, identity~     or end of life concerns. Persistent post treatment pain that adversely affects quality of~     life may be experienced by up to 50% of breast cancer patients. Factors such as depression,~     fear, anxiety or lack of sleep are shown to increase pain and suffering in people with~     cancer. A multitreatment approach treatment of cancer pain is therefore recommended. Art~     therapy offers an opportunity to communicate the experience of suffering in a non verbal mode~     and can be offered in addition to other treatment for pain. This pilot study proposes to~     explore the effect of art therapy on breast cancer patients' perception of pain, and its~     impact on daily functioning by offering four sessions of individual art therapy, spaced~     between one to three weeks apart.~   "
67743|NCT02680223|"~     This is a randomised controlled trial with the aim of testing the efficacy of coloured~     overlays and coloured lenses for the relief of visual stress and reading difficulties in~     children and young adults.~   "
67744|NCT02680210|"~     The study will be conducted over 18 months. The main objective of this study is to explore~     the relationships between autobiographical memory and specific cognitive measures, as well as~     emotional and behavioural measures in patients who have suffered a moderate to severe TBI.~     Secondary objectives are to assess the psychometric properties of a self-defining memories~     questionnaire and to characterize autobiographical memory in the TBI population.~   "
67745|NCT02680197|"~     The study was designed to investigate the efficacy and safety of different doses CHF5259 a~     long acting muscarinic antagonist in patients with moderate to severe COPD.~   "
67746|NCT02680184|"~     A Multicenter, Two-Part, Open-Label, Phase 1b Clinical Study of CMP-001 in Combination with~     Pembrolizumab or as a Monotherapy in Subjects with Advanced Melanoma~   "
67747|NCT02680171|"~     Spatial neglect is a common attention disorder after right hemisphere stroke and is~     associated with decreased independence and quality of life. Despite its high prevalence in~     the stroke population, there is currently no standard of care for the treatment of neglect.~     Prism adaptation (PA) is a promising rehabilitation technique, however incorporation into~     clinical care has been limited likely due to the lack of standardized procedures. The~     investigators have developed a computerized PA technique designed to better engage patients~     and assist clinicians. In this study the investigators aim to evaluate the feasibility and~     effectiveness of the computerized PA procedure in a typical health care setting, with the~     hypothesis that the PA procedure will improve patient's neglect symptoms.~   "
67748|NCT02680158|"~     The purpose of this study is to compare acute tear production produced by the Oculeve~     Intranasal Lacrimal Neurostimulator with two control devices in participants with aqueous~     tear deficiency.~   "
67749|NCT02680145|"~     This is a single center, prospective trial of pessary use prior to reconstructive pelvic~     floor surgery for pelvic organ prolapse. The goal of the study is to evaluate the change in~     pelvic floor symptoms with pessary use and subsequent reconstructive surgery. Additionally,~     we will assess the impact that preoperative pessary use has on patient self-reported~     preparedness for surgery.~   "
67753|NCT02680093|"~     Pregnant Women beyond the date of birth. will be followed while coming to routine monitoring.~     physiological parameter of cervical length will be measured as the differential predictor to~     determine their due date. the cervical length will be measured as part of routine gynecologic~     examination to women who come for routine over due date follow up.~      additional medical data will be collected from the patient medical record.- demographic data,~     and all the routine prenatal medical care the women will receive up to the delivery.and~     delivery outcomes.~   "
67754|NCT02680080|"~     The list of medications that prolong the QT interval and can provoke torsade de pointes keeps~     expanding. This list includes not only antiarrhythmic drugs, but also medications with no~     cardiac indications. All these medications prolong the QT interval because they block a~     specific potassium channel on the myocardial cell membrane: the channel for the rapid~     component of the delayed rectifier potassium current or IKr. The risk for developing~     torsade de pointes for patients taking any of the medications with IKr blockade capabilities~     varies from >4% for antiarrhythmic drugs to <0.01% for non-cardiac medications. The risk~     depends on the strength of IKr blockade, but also on specific patient characteristics. The~     majority of patients who develop torsade de pointes from non-cardiac medications have~     identifiable risk factors. In this regard, patients with a congenital long QT syndrome are~     prone to develop torsade de pointes when treated with QT-prolonging medications. This is~     because, due to their genetically defective ion channels, patients with Long QT Syndrome~     (LQTS) have impaired ventricular repolarization and reduced repolarization reserve.~     Therefore, it is common medical practice to strongly advise patients with congenital LQTS to~     avoid all medications that have IKr channel blocker capabilities. it was reported that some~     flavonoids contained in pink-grapefruit juice block the IKr channel. These investigators also~     reported that drinking 1 liter of pink-grapefruit juice causes QT prolongation in healthy~     volunteers. The magnitude of the QT prolongation provoked by grapefruit juice was small~     However, drugs causing minor QT prolongation in healthy volunteers may provoke major QT~     prolongation in rare or sick individuals who are then at risk for developing torsade de~     pointes. Consequently, one could argue that, until proven otherwise, pink-grapefruit should~     be added to the list of drugs that are forbidden for patients with LQTS~   "
67755|NCT02680067|"~     In this phase 1 study, the lymphatic transport will be examined using Near InfraRed~     Indocyanine Green fluorescence imaging (NIR-ICG) of the upper extremities in healthy~     individuals using a MultiSpectral Imaging System (MSImager).~   "
67756|NCT02680054|"~     The aims of the study are to see if additional insulin doses for the fat and protein in a~     meal, given at different times, improve blood glucose levels and are safe and acceptable to~     children with Type 1 diabetes using multiple daily insulin injections.~   "
67757|NCT02680041|"~     This prospective study will enroll up to 330 men with PSA-persistent or PSA-recurrent~     prostate cancer after curative-intent primary therapy and negative or equivocal findings on~     standard-of-care imaging. Consenting participants will be imaged with 18F-fluciclovine~     PET/CT. Site clinicians will manage study subjects per standard practices and will document~     any change in treatment based on review of 18F-fluciclovine PET/CT findings. All participants~     will be followed for up to 6 months, with clinical data collected for this study. An~     interdisciplinary panel will provide expert guidance to local readers on request. The final~     reporting of the PET/CT scan will be a single report by the local reader following any such~     discussion.~   "
67758|NCT02680028|"~     In England each year over 65,000 people fracture their hip. Most of these patients are~     elderly females with the fracture occurring after a simple trip or stumble. Approximately~     half of these fractures are classified from their relationship to the hip joint capsule as~     extracapsular. The majority of these fractures are treated surgically by internal fixation~     using, either a plate and screws (sliding hip screw) or nail and screws (intramedullary~     nail).~      Recent randomised studies from Peterborough involving 1000 patients have indicated that there~     are modest benefits for treating this type of fracture with an intramedullary nail in~     comparison to a sliding hip screw. This study aims to progress from these earlier studies to~     determine if a slightly thinner and shorter intramedullary nail (175mm in length), has any~     significant advantages or disadvantages to the standard length (220mm) intramedullary nail.~      Both implants to be used in this study are in routine use around the world and are being used~     within their licenced indication. The study is therefore using two different designs of~     implant within their recommended area of use, but in which there is uncertainty as to which~     is the best design.~   "
67759|NCT02680015|"~     This study examines how the PEERS (Laugeson & Frankel, 2010; Laugeson, 2016)~     social-behavioral intervention affects social relationships, and brain development and~     function in adolescents and young adults with autism spectrum disorder.~   "
67760|NCT02680002|"~     The main purpose of this study is to assess the usability of long-term stored H5N1 antigen~     and adjuvant. The study is designed to assist in stockpile management by assessing the~     safety, reactogenicity, and immunogenicity long-term stored influenza A/Vietnam/H5N1 vaccine~     when administered with or without MF59® adjuvant.~   "
67761|NCT02679989|"~     An intermittent energy restricted (IER) diet may modify cardio-metabolic disease risk factors~     compared to an energy-matched continuous energy restricted (CER) diet. A randomised~     controlled parallel design trial will determine the impact of a short-term IER diet (2~     consecutive days of very low calorie diet (VLCD), 5 days moderate energy restriction each~     week for a 4 week period), compared to a CER diet, on insulin sensitivity in healthy~     (disease-free) subjects with central obesity.~   "
67762|NCT02679976|"~     This is a single-visit prospective study to establish a real world Marketed Contact Lens~     'Through Focus Curve' (TFC) measurement by comparing the consistency of vision between myopes~     and hyperopes. 33 subjects will be enrolled (at least 15 myopes and 15 hyperopes), who are 40~     years of age or older, for a 1-visit, 4-hour study for measurements to be taken.~   "
67784|NCT02679690|"~     Develop an evidence-based intervention aimed at patients with heart failure (HF) using~     color-coded cue cards to assist in the selection of foods appropriate to their sodium~     restricted diet. The milligram per serving sodium content of foods will be assigned~     color-coded green/yellow/red designation according to very low/moderate/high as identified by~     the United States Food and Drug Administration's definitions of sodium content.~      Assess patient knowledge of foods with sodium content appropriate for consumption on a low~     sodium diet before implementation of the intervention by calculating average milligrams of~     sodium per serving via choices made through simulated grocery store shopping.~      Evaluate application of patient knowledge about low-sodium food choices using a simulated~     grocery store shopping intervention by calculating average milligrams of sodium per serving~     via choices made using the color-coded card.~   "
67821|NCT02679196|"~     Multiple ascending dose study to evaluate safety/tolerability, pharmacokinetic and~     pharmacodynamics effects of KA2237 (PI3 Kinase p110β/δ Inhibitor) in patients with B Cell~     Lymphoma and determine the maximum tolerated dose (MTD) in Part I of the study. In Part II,~     patients with B cell lymphoma will be treated with KA2237 at the MTD to evaluate safety and~     efficacy in the patient population.~   "
67763|NCT02679963|"~     This is a multicentre randomised double-blind phase II trial, sponsored by Gustave Roussy and~     involving one French center as well as the Spanish Lung Cancer Group (≈20 centers of the~     SLCG).~      Six hundred patients with diagnosis of stage IIIB/IV NSCLC will initially be registered prior~     to receiving the first line platinum-based chemotherapy or during or at the end of the first~     6 cycles of inducation platinium based chemotherapy and provide consent for retrieving~     archival tissue collection and providing translational blood samples and tumor biopsies.~        1. - Induction chemotherapy phase All patients will initially be treated with 6 cycles of~          platinum-based induction chemotherapy. Cycle duration will be 21 days. Doublets should~          either consist of a pemetrexed-platinum (cisplatin or carboplatin) doublet~          (preferentially for non-squamous NSCLC) or a gemcitabine - or vinorelbine - platinum~          doublet for squamous NSCLC. Taxanes-platinum doublets will not be accepted.~          Translational blood samples will be taken at the beginning of induction chemotherapy for~          all patients.~           Patients displaying progressive disease or stable disease after induction chemotherapy~          will be withdrawn and further optimally managed according to local practice. For them,~          an optional tumour biopsy will be performed at the end of the induction treatment.~        2. - Randomisation and maintenance phase Only patients who respond to platinum-based~          induction chemotherapy will be further randomised between olaparib and placebo. These~          patients must have been treated with 6 cycles of chemotherapy. However, patients who~          haven't received 6 cycles of the induction chemotherapy due to severe toxicity (grade 3~          or 4, NCI CTCAE v4.0) could be randomized only if they had received 4 chemotherapy~          cycles at least and if all treatment related toxicities are resolved to a grade ≤ 1 (NCI~          CTCAE v4.0).~      Treatment will be administered at a dose of 600 mg daily (2 doses of 300 mg [2 tablets of 150~     mg] taken approximately 12 hours apart) and cycle duration will be 28 days. Disease will be~     assessed every 2 cycles by CTscan (MRI or PET-scan if the scan is not contributive) and~     treatment will be administered until disease progression or unacceptable toxicity. Patients~     will then be optimally managed according to local practice. Follow-up will be for a minimum~     of 15 months from the time of randomization, and until last venue. All randomised patients~     will be asked to provide translational blood samples at randomization, on treatment and at~     the end of the treatment. Optional tumour biopsies will be performed at randomization, at the~     end of the treatment (or at disease progression if available).~   "
67764|NCT02679950|"~     The current proposal is a pilot study. The Investigators plan to use next generation genome~     sequencing (NGGS) to define the molecular and genetic profiles of 3 cases of germ cell tumor~     (GCT) (with a component of yolk sac tumor) at the time of the initial diagnosis and 3 cases~     of late relapse GCT's, which are characterized by yolk sac tumor (and AFP secreting)~     predominant disease.~      Investigators seek to demonstrate the feasibility of obtaining tissue biopsies (either~     archived or new biopsy) and utilization of NGGS in studying the molecular and genetic~     relationships between GCT's (with a component of yolk sac tumor) at the time of diagnosis and~     GCT's at the time of late relapse. This study will also provide preliminary information on~     genetic alterations, which may be a hypothesis for generating another study.~   "
67765|NCT02679937|"~     This randomized controlled trial assesses the efficacy of a 6-week, dissonance-based,~     weight-gain prevention program (Fit4Duty) designed to reduce unhealthy weight gain among~     military service members at-risk for obesity. The Fit4Duty program is an adaptation for the~     military of an existing civilian obesity prevention program, Project Health, which reduced~     obesity onset by 50% in healthy civilian young adults. Fit4Duty is compared to a nutrition~     education control condition and is hypothesized to reduce excess weight gain beyond the~     control comparison program during the 2 year period following study participation.~   "
67766|NCT02679924|"~     Soft tissue augmentation with injectable hyaluronic acid (HA) is a well-established modality~     for the correction of facial volume loss, fat atrophy, fine lines, and wrinkles. HA is a~     glycosaminoglycan that is composed of repeating D-glucuronic acid and D-N-acetylglucosamine~     disaccharide units. Because HA is a natural and inert constituent of the dermis, it~     represents an ideal substance for soft tissue augmentation. Current FDA-approved HA fillers~     are typically utilized to either directly target specific cutaneous rhytids or to restore~     overall contours by placement into fat pads or along bony structures that have remodeled with~     age. Restylane® Silk is a transparent injectable HA gel that received FDA approval in June~     2014 for use in the lips and peri-oral region. Its unique synthesis results in smaller and~     finer particles that demonstrate significant hygroscopic properties and give rise to the~     potential for unique applications. One such application concerns the concept of skin~     boosting whereby microaliquots of HA are placed into the skin to induce biophysical~     improvement in dermal characteristics (1). Using this technique, a recent split-body study by~     Streker et al. demonstrated significant aesthetic improvements in face, hands and décolletage~     (2). However, there have been no well-controlled studies with validated aesthetic outcomes~     utilizing Restylane® Silk in this fashion to date. Because of the unique combination of~     ultra-fine product and high water-attracting capability, the investigators hypothesize that~     microinjections of Restylane® Silk can be used in a grid-like injection pattern for~     rejuvenation of the aging cheek.~   "
67767|NCT02679911|"~     The main objective of this study is to compare subject's compliance and satisfaction for two~     modes of treatment of toenails infection (Onychomycosis) with Loceryl Nail Lacquer (Loceryl~     NL) and Ciclopirox Nail Lacquer (Ciclopirox NL).~   "
67768|NCT02679898|"~     Obesity is directly related to arterial dysfunction and negatively associated to muscle~     strength. High-intensity resistance exercise is the favored modality to offset muscle~     weakness, yet, adverse effects on arterial function (pulse wave velocity, wave reflection,~     and aortic and brachial blood pressures) have been observed. Conventional unloaded-whole body~     vibration training (WBVT) has improved arterial function in overweight/obese women but~     appears to be low-intensity. Nevertheless, the effects of moderate-intensity (by adding~     external load) WBVT on arterial and muscle function are unknown. Therefore, the purpose of~     this study was to examine whether loaded-WBVT would induce greater benefits than~     unloaded-WBVT on arterial and muscle function in young overweight/obese women. Furthermore,~     we examined whether these changes were similar to healthy lean young women.~   "
67769|NCT02679885|"~     It is known that teriflunomide, a treatment for relapsing forms of multiple sclerosis, can be~     found in low concentrations in semen. Because the drug has been associated with~     teratogenicity in laboratory animals, the question is raised as to whether the drug can be~     detected in female partners of sexually active males who are taking the drug to treat their~     multiple sclerosis.~   "
67770|NCT02679872|"~     Good non-technical skills (NTS) have been shown to prevent adverse events and errors.~     Improvements of NTS can be achieved by simulation based-team training.The NTS of the~     operating theatre team performing video-assisted thoracoscopic surgery (VATS) is speculated~     to differ fra open thoracic surgery, as is the case with technical skills; however, these~     have not been investigated. The aim of this study is to explore which NTS the members of the~     VATS team perceive to be most important to patient care and safety. Exploration will be done~     through a deductive, qualitative analysis of semi-structured group and individual interviews~     with VATS team members. A theoretical perspective of Hollnagels Safety-II will be taken using~     the taxonomy of Oxford Non-Technical Skills (NOTECHS) system with the aim of informing~     patient safety.~   "
67771|NCT02679859|"~     The primary hypothesis of the BETTER pilot trial is that B-type natriuretic peptide (BNP)~     directed medical therapy prior to noncardiac surgery will be associated with improved~     cardiovascular outcomes, when compared to standard of care.~   "
67772|NCT02679846|"~     SAVE is a stratified cluster-randomised controlled, parallel group, open-label trial, with~     Epileptic Monitoring Unit (EMU) as the units of randomisation and patients as the unit of~     analysis.~      The focus of research is the management of AntiEpileptic Drugs (AEDs) withdrawal during long~     term Video EEG (VEEG) monitoring in patients with drug resistant seizures. This~     non-standardised medical practice, which aims at promoting the occurrence of seizures during~     the time limit of the monitoring period, exposes patients to significant risks which should~     be minimised by harmonisation of practice and a standardised protocol of AEDs withdrawal.~      SAVE will assess the impact of a standardised protocol of AEDs withdrawal during long-term~     VEEG monitoring on the frequency of seizure-related serious adverse events occurring during~     these monitorings and on the ability to obtain VEEG recording of seizures within appropriate~     time limits.~      10 of the 22 EMUs will be randomised to the group where the standardised protocol of AEDs~     withdrawal will be used systematically, while the other ten EMUs will continue their current~     non-standardised practice of AEDs withdrawal, and will serve as a control group.~      The setting of the study will include a 6 months evaluation phase, prior to randomisation,~     during which the organisational characteristics, baseline EMUs' activity, current management~     of AEDs withdrawal, and rate of Serious Adverse Events (SAEs) of each participating center~     will be evaluated.~      The standardised study protocol of AEDs withdrawal has been defined on the basis of a~     systematic review of all relevant publications in the field.~   "
67773|NCT02679833|"~     A 3 months randomized, placebo-controlled study on the effect of toothpaste fortified with~     vitamin B12 on vitamin B12 status markers and related metabolic markers. The primary outcome~     variable is the difference in the change of methylmalonic acid after 3 months between the two~     study arms.~   "
67774|NCT02679820|"~     The immediate post cesarean section IUD insertion is a further step towards spreading more~     compliance to females in developing countries, with rapid increase in population size~   "
67775|NCT02679807|"~     This is a randomized, double-blind placebo controlled trial to evaluate the effect of a~     probiotic (Bl-04) on the occurrence of rhinovirus-associated common cold illness in the~     experimental rhinovirus challenge model. A previous study documented that Bl-04 has~     significant effects on the innate immune response in the nose and this study will be powered~     to assess whether these effects translate into a demonstrable clinical benefit. Volunteers~     will be given Bl-04 or placebo for 28 days then challenged with rhinovirus. The primary~     analysis will be on the proportion of volunteers who develop a rhinovirus associated illness~     in the two treatment groups.~   "
67776|NCT02679794|"~     The 2010 Dietary Guidelines for Americans emphasizes consumption of 4.5 cups of fruits and~     vegetables daily but the average intake of US adults is only 2.6 cups. This low consumption~     of fruits and vegetables results in a limited availability of certain nutrients found in~     these foods such as carotenoids. Dietary carotenoids have health-promoting properties and are~     known to fight against disease. Although, maintaining adequate vitamin D status is critical~     for overall skeletal health and the prevention of osteoporosis, vitamin D insufficiency is~     also widespread in the United States. Eggs, egg yolk in particular, are known to be a good~     source of lipid and may improve the absorption of carotenoids and vitamin D found in~     co-consumed vegetables in young and older women. Therefore, the investigators are interested~     to see if consuming eggs with cooked vegetables will increase carotenoids and vitamin D~     absorption.~   "
67777|NCT02679781|"~     The general objective of the study is to compare the efficacy of administering midazolam~     orally as syrup versus nasally with nasal atomizer. The specific objectives are to measure:~     1) acceptability of the medication, 2) effect on behavior, 3) time of onset, 4) maximum~     working time.~   "
67778|NCT02679768|"~     Very little is known of depressed patients' mental state after being discharged from~     inpatient wards where they are provided with a sheltered environment with stable sleep wake~     cycle, regular meals, and regular physical and social activities. Our previous usability~     study, SAFE I, showed that electronic self-monitoring was a useful tool to gain insight into~     patients' condition in the weeks after discharge. Results showed that patients over a four~     week period had significant day to day variations in self-rated mood and sleeping schedule~     and that the patients' sleep patterns were delayed with 45 minutes.~      In the actual study, SAFE II, we are investigating whether an intervention with a strong~     focus on the circadian timing of daytime activities, and sleep, coined Circadian~     Reinforcement Therapy (CRT), can lead to a faster recovery of depression and prevent relapse~     into depression after discharge.~   "
67779|NCT02679755|"~     A study of palbociclib in combination with letrozole as treatment of post-menopausal women~     with hormone receptor-positive, her2-negative advanced breast cancer for whom letrozole~     therapy is deemed appropriate.~   "
67780|NCT02679742|"~     A randomized, double-blind, placebo-controlled, parallel study to assess the effects of~     β-hydroxymethylbutyrate (β-HMB) combined with a resistance training program, after an acute~     process in older patients with sarcopenia in terms of muscle mass, muscle strength and~     physical performance. Treatments compared will be β-hydroxymethylbutyrate (β-HMB) with a~     resistance training program or placebo with a resistance training program.~   "
67781|NCT02679729|"~     This is a Phase 1, first-in-human (FIH) single ascending dose study being conducted to better~     understand the safety, tolerability and pharmacokinetics of AZD5634 in healthy subjects~   "
67782|NCT02679716|"~     Retinal artery occlusions (RAO) cause deterioration in visual acuity and visual fields. In~     computational fluid dynamics (CFD) studies (Leisser et al.) 10% of ascending emboli caused~     RAO, the residual 90% embolized into the cerebral arteries. As only 20% of patients with RAO~     had a history of stroke, there is a discrepancy between CFD-studies and clinical~     observations. Mead et al. postulated small emboli being washed into the cerebral arteries~     without causing clinical symptoms of stroke, whereas similar emboli being washed into the~     ophthalmic artery would cause RAO.~      There is a discrepancy between CFD-study results and clinical observations in RAO patients,~     indicating that there could be a high number of RAO-patients having had cerebral ischemies~     without symptoms of stroke (as postulated by Mead et al.).~      Purpose of the present study is to evaluate hemodynamic pathological changes at the~     ophthalmic artery origin in patients with RAO detected with an already existing CFD-model~   "
67783|NCT02679703|"~     To evaluate the effect of the polarity of the electric current in healing.~   "
87437|NCT02422576|"~     Assessment of the improvement of the safety of the swallowing function under 3 natural~     ingredients known to be agonist of sensory receptors.~   "
67785|NCT02679677|"~     The typical clinical progression of COPD usually results in a decreased level of tolerable~     physical exertion for the patient. The avoidance of strenuous physical activity leads to a~     deteriorating level of physical fitness, which further decreases the patient's ability to~     undertake physical activities. Recent research has shown that whole body vibration has the~     potential to improve physical fitness of participants, including such measures as the 6~     minute walking distance. However, information concerning lung function is lacking.~      The goal of the study is to test whether the use of whole body vibration training has an~     effect on the lung function of patients with stable COPD, or if the previously observed~     effects can be attributed to either pharmaceutical therapy or physical therapy interventions.~   "
67786|NCT02679664|"~     The SAVER pilot is a randomized, open-label pilot study to determine the feasibility of~     recruitment. In addition to feasibility data, the investigators will carefully collect~     clinical data to determine if rosuvastatin can reduce post-thrombotic syndrome (PTS) in~     venous thromboembolism (VTE) patients.~      Eligible consenting patients who developed acute, symptomatic, and objectively confirmed~     proximal leg deep vein thrombosis (DVT) and/or PE will be randomized and equally allocated to~     2 trial arms, either the treatment group (rosuvastatin tablet (20 mg/day) or the control~     group (usual care). The pilot trial consists of up to 4 study contacts over 6 months:~     screening, randomization, telephone follow-up (90 days), and final study visit (180 days).~   "
67787|NCT02679651|"~     The investigators hypothesize that there is a difference in plantar tissue thickness, plantar~     pressure, and pain score in patients diagnosed with plantar fat pad atrophy compared to~     healthy, foot-type matched controls. Results will be measured objectively using ultrasound~     for tissue thickness, optical pedobarograph for plantar pressure, and Manchester foot pain~     and disability index (MFPDI) for pain score. Furthermore, investigators predict that these~     results will help establish criteria for fad pad atrophy diagnosis in the clinic as well as~     determine which patients would receive greatest benefit from fat grafting to the foot.~   "
67788|NCT02679638|"~     A Multi-center Cross-sectional quantitative study with a preliminary qualitative study part~     aiming to identify and analyze demand factors, supply factors and perceptions affecting~     Breast Cancer patients' treatment choices of Breast Cancer patients in 5 key decision points:~     participation role in the decision making process, hospital choice, treatment regimen choice,~     surgical extent and surgeon choice. 25 patients and caregivers will participate in the~     qualitative part and 425 Israeli Breast Cancer patients will participate in the quantitative~     study.~   "
67789|NCT02679625|"~     Accurate assessment of fluid responsiveness (FRes) is central to guiding fluid management in~     septic and critically ill patients. As evidence accumulates that both inadequate and~     excessive fluid resuscitation are associated with increased morbidity and mortality, it is~     simultaneously becoming increasingly clear that current widely used methods to predict FRes~     are of questionable accuracy. The optimal technique to predict FRes would be a non-invasive~     point-of-care test with not only a high degree of accuracy, but also one which requires~     minimal training to perform correctly and may be easily performed repeatedly for serial~     evaluation of FRes during the ongoing management of the critically ill patient.~      To date, three major ultrasonographic modalities have emerged as viable candidates for the~     bedside assessment of FRes: 1) measurement of dynamic changes in inferior vena caval diameter~     (IVC-CI), 2) measurement of dynamic changes in peripheral arterial waveform derived variables~     (PA Doppler), and 3) echocardiographic measurement of dynamic changes in left ventricular~     outflow tract waveform derived variables (LVOT Doppler). In this study, the investigators~     will perform the first direct comparison of techniques representing all three of the above~     modalities in the prediction of FRes against a non-invasive bioreactance cardiac output~     monitor (the Cheetah NICOM™), which has been extensively validated against gold-standard~     invasive methods of cardiac output measurement. The investigators will compare the accuracy~     of these modalities in both spontaneously breathing and mechanically ventilated patients~     using passive leg raise testing (PLR) as a surrogate for volume challenge. In addition, the~     investigators will also elicit information from the treating physician(s) on their clinical~     assessment of FRes.~      The investigators will recruit adult patients in the ED and ICU with sepsis, who have~     received an initial bolus of 20-30 cc/kg of IV fluid, and can tolerate the PLR and US~     procedures. Prior to US and NICOM measurement, investigators will ask the attending physician~     managing the patient regarding their assessment of the their fluid status. Then, separate~     investigators will perform US and NICOM measurements independently to ensure blinding. NICOM~     data, which has been well validated in septic patients, will be shared with the attending~     physician. They will then be asked if this new data will change management.~   "
67790|NCT02679599|"~     Cardiac rehabilitation patients often fail to exercise as prescribed on days they are not~     attending rehabilitation and there is a steep drop off in exercise following rehabilitation~     completion. Moreover, little is known about the amount of time that cardiac rehabilitation~     patients spend in sedentary behavior, which is associated with increased risk of~     cardiovascular morbidity and mortality, independent of time spent in exercise. This pilot~     study aims to test acceptability, feasibility, and preliminary efficacy of a smartphone~     application (B-MOBILE-CARDIAC) for increasing time spent in moderate-to-vigorous intensity~     physical activity accumulated in bouts of at least 10 minutes in duration (i.e. bout-related~     MVPA) and decrease time spent in sedentary behavior. Up to 32 patients will be recruited,~     enrolled, and randomized during the first 2 weeks of cardiac rehabilitation to either: 1)~     B-MOBILE-CARDIAC plus cardiac rehabilitation or 2) cardiac rehabilitation alone. Participants~     will complete 7 days of objective activity monitoring to measure daily minutes spent in~     bout-related MVPA and sedentary behavior (primary outcomes) at baseline, mid-rehabilitation~     (6 weeks), end of cardiac rehabilitation (12 weeks), and 4-week follow-up (16 weeks). At~     these same time points, participants will complete questionnaires assessing sedentary~     behavior, MVPA, exercise tolerance, health-related quality of life, mood, and affect. At~     baseline and end of cardiac rehabilitation participants will undergo a blood draw to measure~     cardiometabolic and inflammatory risk factors and complete a test of cognitive functioning.~     Feasibility and acceptability of the B-MOBILE-CARDIAC application will be assessed at the~     4-week follow-up.~   "
67791|NCT02679586|"~     This is a single-arm, single-institution pilot study that will collect preliminary data to be~     used in the design of a subsequent study to assess whether changes in fDM (Functional~     Diffusion Maps) derived from primary breast cancer diffusion weighted MRI images can serve as~     an early predictor of response to treatment, and whether the magnitude of the change~     correlates with the effectiveness of treatment.~   "
67792|NCT02679573|"~     The purpose of this study is to evaluate the safety and efficacy of delafloxacin compared to~     moxifloxacin in the treatment of adult patients with community-acquired pneumonia.~   "
67818|NCT02679235|"~     BEAT7-001 is a single group study (supplementation). Using a multi-modal brain imaging~     portfolio, this study will assess whether brain energy metabolism (glucose and ketones),~     structure or functional connectivity change in older people with frontal glucose~     hypometabolism after 28 days on an oral dose of 1 g/kg/day of triheptanoin.~   "
67793|NCT02679560|"~     This is an investigator-initiated, single-center, randomized, patient blinded, controlled~     trial. The purpose of this study is to compare the effect of a fascia iliaca compartment~     block (FICB) using 0.2% ropivacaine vs. liposomal bupivacaine in patients with femur and/or~     hip fractures admitted to the University of California Davis Medical Center (UCDMC). The~     primary endpoint will be the total opioid requirements during the 72 hour randomization~     period with secondary endpoints including total daily opioid requirements for days 1-3,~     duration of effect and objective pain scores using the numeric rating scale (NRS) during~     their hospital stay.~   "
67794|NCT02679547|"~     Appendectomy is the most common emergent operative procedure performed worldwide. In this~     study investigators will investigate if there is a relationship between breast feeding and~     appendicitis in adults.~   "
67795|NCT02679534|"~     Postoperative pain is a common phenomenon in the intensive care unit (ICU) despite the~     multitude of efforts dedicated to promote its effective relief. Mounting evidence shows that~     cardiac surgery ICU patients experience moderate to severe pain reaching proportions as high~     as 74% despite the use of analgesics. The highest pain intensity is experienced in the first~     24 hours post surgery when patients are still in the ICU, and represents a strong predictor~     for the presence and severity of persistent postoperative pain. To maximize pain relief,~     massage has been suggested in the recent clinical practice guidelines of the Society of~     Critical-Care Medicine as a complementary non-pharmacological therapy in the ICU given its~     opioid-sparing and analgesia-enhancing potential. Some randomized controlled trials showed~     promising pain relief effects of massage when administered to cardiac surgery patients in~     acute care units, however, its effects on pain relief while patients are still in the ICU and~     when pain severity is highest remain unknown.~      This study aims to compare the effect of three 20-minute hand massage administrations within~     24 hours postop on the pain intensity (primary outcome), pain unpleasantness, pain~     interference, muscle tension, anxiety and vital signs (blood pressure, heart and respiratory~     rates) of adult intensive care unit (ICU) patients post cardiac surgery versus hand holding~     (i.e., simple touch) and standard care. Other objectives are to describe the location and~     quality of pain of cardiac surgery ICU patients.~      Hypothesis:~      Patients receiving 3 hand massages within 24 hours postop will have lower pain intensity,~     unpleasantness and interference, muscle tension, anxiety and vital signs compared to patients~     receiving hand holding and to those in the standard care group.~   "
67796|NCT02679521|"~     Radial extracorporeal shock wave therapy (rESWT) has been previously demonstrated as an~     efficient treatment option for heel pain associated with chronic proximal plantar fasciitis~     when administered in three sessions. The present study tested the hypothesis that heel pain~     associated with chronic proximal plantar fasciitis can also be treated successfully with~     rESWT when only two treatment sessions are performed.~   "
67797|NCT02679508|"~     The purpose of this study is exploratorily evaluate the effect on gastric mucosal tissue and~     the safety of long-term administration (260 weeks: 5 years) of vonoprazan 10 mg or 20 mg in~     patients receiving maintenance treatment after healed erosive esophagitis (EE), and the~     curative effect of vonoprazan 20 mg versus lansoprazole in patients with EE.~   "
67798|NCT02679495|"~     The purpose of this study is to determine whether positive life style interventions (such as~     diet modification and smoking cessation) are effective in the prevention of gastric~     pre-cancer and cancer occurrences and reccurence of gastric cancer after edoscopica~     resection.~   "
67799|NCT02679482|"~     The purpose of this study is to follow and describe the outcomes of patients after selective~     and pascal laser trabeculoplasty treatment for chronic open-angle glaucoma.~   "
67800|NCT02679469|"~     The safety, tolerability, and pharmacokinetics of nalmefene at a single oral dose of 10 mg in~     healthy Japanese male subjects will be evaluated.~   "
67801|NCT02679456|"~     This is a randomized, multicenter, evaluator blinded study to evaluate the safety,~     tolerability, efficacy and pharmacokinetics of SCY-078 compared to Fluconazole in adult~     patients with moderate to severe Vulvovaginal Candidiasis (VVC) and a history of frequent~     episodes of VVC. Approximately 90 subjects, meeting the inclusion criteria will be enrolled~     and randomized in a 1:1:1 ratio to one of the 3 treatment arms: Oral SCY-078 in 2 dose~     regimens or oral Fluconazole. After enrollment, subjects will be evaluated on Day-5 (end of~     treatment visit), Day-24 (test of cure visit), Day-60, Day 90 and Day 120 (end of observation~     period visit) or at any time that a recurrence or clinical failure is suspected, up to the~     end of observation period.~   "
67802|NCT02679443|"~     Folic acid (FA; folate) in the dose of 350-1,000 μg daily should be supplemented, daily,~     starting 7 days before the first dose of pemetrexed based chemotherapy and should be~     continued while the patient is on therapy and for 21 days after cessation of therapy. Vitamin~     B12 injections (1,000 μg i.m.) should also be started 1 week before the first dose of~     chemotherapy. However, the evidence for delaying chemotherapy by seven days for the purpose~     of giving vitamin B12 and FA supplementation is not robust. Observational and prospective~     single arm studies have not shown any increased toxicity if pemetrexed was started earlier~     than the recommended duration of supplementation. In a resource constrained setting, this~     will lead to one additional visit and 1-week chemotherapy delay which may be inconvenient for~     patients.~      Hence an open label, randomized control trial is being undertaken to evaluate if there are~     any differences in pemetrexed related hematological toxicity amongst patients who receive~     delayed initiation of chemotherapy (following 5 - 7 days of vitamin B12 and FA~     supplementation; Delayed Arm) as compared to those in whom vitamin B12 and FA supplementation~     is starting simultaneously (within 24 hours) of initiation of chemotherapy (Immediate Arm).~   "
67803|NCT02679430|"~     Investigators hypothesis that arterial embolization of men with symptomatic BPH, analogous to~     uterine fibroid embolization for women, is safe and effective.~   "
67804|NCT02679417|"~     The type of physical activity such as, aerobic or resistant exercise required to reduce liver~     fat content in patient with non-alcoholic fatty liver disease (NAFLD) remains unclear. The~     purpose of this study is to determine whether aerobic exercise should provide improvement of~     hepatic fat content and inflammation as well as metabolic profiles and anthropometric~     parameters better than resistant exercise.~   "
67819|NCT02679222|"~     The aim of this study is to compare the ketogenic effect of coconut oil and three MCT oils~     (60-40 , tricaprylin and triheptanoate) on the production of ketones in healthy adults. Each~     oil are evaluated individually or in combination over a 8h-period during which repeated blood~     sampling is performed.~   "
67805|NCT02679404|"~     Multi-center, International, Prospective, Non comparative, Non randomized, Open label.~      5,000 patients to be enrolled approximately worldwide.~      The objective of this registry is to collect safety and clinical performance post market data~     related to the procedure and follow-up of the Sorin Group aortic valve devices in accordance~     with the Instructions for Use (IFU).~      This observational global registry is intended to collect data without requiring any~     deviation from the standard of care and IFU in each participating center. The participating~     centers shall include those patients that have provided their informed consent to participate~     in this registry in accordance with the local applicable regulations.~   "
67806|NCT02679391|"~     The primary aim of this study is to compare early surgical complications after abdominoplasty~     performed by plastic and general surgeons. Secondary aims were to assess whether specific~     guidelines might have impact on the rate of complications. The hypothesis is that general~     surgeons have more complications.~   "
67807|NCT02679378|"~     Prospective, single-arm, multicenter, open label, non-randomized exploratory clinical study~     comparing ClearSight system to histopathological to determine negative-margins in breast~     conserving surgery.~   "
67808|NCT02679365|"~     In this trial we compare the effect of 2 closure techniques of the rectus sheath during~     cesarean sections on postoperative pain. One closure technique is double lock technique and~     the other is the conventional continuous non-locking technique.~   "
67809|NCT02679352|"~     Shoulder arthroplasty is a reliable procedure for the treatment of severe shoulder joint~     diseases to relieve pain and restore shoulder function.~      Shoulder implants commonly used are characterised by a humeral stem and complications related~     to the stem are not infrequent. These include: bone stock loss, intraoperative and~     postoperative break around the implant, malpositioning of the humeral component and difficult~     eradication of infections inside the bone around the implant.~      With the aim of reducing stem-related complications, a novel prosthesis characterised by a~     stem-less design has been developed.~      The objective of this study is therefore to explore how well people recover after shoulder~     replacement with this novel stem-less shoulder prosthesis. This will be assessed over 5 years~     in three different countries in Europe using patient completed questionnaires and clinical~     and radiographic assessments.~   "
67810|NCT02679339|"~     Study 2022-HZ-011 will utilize a randomized withdrawal (RW), double-blind, placebo controlled~     design in which the PK and safety of CNTX 2022 (40% anhydrous lidocaine gel) will be~     evaluated in subjects with acute-onset herpes zoster pain.~   "
67811|NCT02679326|"~     The purpose of this study is to determine whether Therapeutic Ultrasound is effective in the~     treatment of Plantar fasciitis (PF).~   "
67812|NCT02679313|"~     This study will compare near clinical oculomotor parameters (heterophoria, vergence ranges,~     AC/A and accommodative findings) measured when lenses and/or prisms are introduced using~     three different instruments namely: (i) a standard manual phoropter, (ii) an electronic~     phoropter and (iii) a wearable adaptive refractor (VisionFit).~   "
67813|NCT02679300|"~     Immersion in a virtual reality environment has been shown to reduce pain during a variety of~     painful medical procedures, such as wound care for burn patients and dental care. Often,~     serious games are used to distract patients from this painful procedures. Recently, serious~     games have also been developed for patients with low back pain. Because patients with low~     back pain frequently experience pain during exercises, the investigators hypothesize that~     exercising with serious games can reduce the pain intensity and the time spent thinking of~     pain during exercises. To test this hypothesis, the investigators will conduct a randomized~     controlled trial where two groups will be compared: the experimental group will perform one~     session of exercises with serious games, while the control group will perform one session of~     the same exercises without the serious games.~   "
67814|NCT02679287|"~     The purpose of this study is to use an investigational type of technology called Closed-Loop~     Control (CLC) Medical Platform System to help control blood sugar in people with type 1~     diabetes mellitus in a home setting.~   "
67815|NCT02679274|"~     Frailty is a recognized cause for disability, hospitalization, and mortality in nursing home~     residents. Testosterone treatment is among the potentially beneficial treatments in addition~     to resistance exercise for improving muscle strength and mass in frail adults. The~     investigators have demonstrated that cycled administration of testosterone improves muscle~     mass and strength in healthy adults. It is proposed that cycled testosterone administration~     may be an effective adjuvant therapy for frail older men and women during rehabilitation~     programs. The hypothesis is that testosterone treatment in addition to standard-of-care (SOC)~     rehabilitation will result in improved muscle mass and physical function when compared to~     patients receiving SOC only. Therefore, in a randomized, double-blind, placebo controlled~     study, the investigators will test the effects of cycled testosterone administration (2 week~     on treatment, 2 weeks off treatment) on body composition and physical function in male and~     female nursing home residents undergoing rehabilitative care. Primary outcomes will be~     assessed before and after 10 weeks of treatment using bioelectric impedance, handgrip~     dynamometers, short physical performance battery (SPPB), and quality of life (QOL)~     questionnaires. Data from this pilot project will become the foundation for the development~     of a larger long-term project solicitation to the NIH aimed at elucidating the efficacy of~     testosterone treatment on physical function and independence in frail older adults.~   "
67816|NCT02679261|"~     Bicuspid Aortic Valve (BAV) is the most common congenital heart disease affecting 1-2% of the~     population. The aortic dilation and aortic valve degeneration are common complications in~     patients with BAV. Statins have shown a reduction in the expression of metalloproteinases of~     the extracellular matrix observed in aortic aneurisms. Several retrospective studies have~     suggested the benefit of the statins to reduce aortic dilation in patients with BAV.~     Moreover, although statins did not show to be useful in the progression of aortic stenosis,~     different studies have suggested a higher profit when the valve affection is not severe. The~     objective of this study is to determine whether atorvastatin is effective at reducing the~     progression of aortic dilation in patients with BAV.~   "
67817|NCT02679248|"~     This study will investigate the effect of a nitric oxide supplementation product, Neo40~     Daily®, on blood pressure in pre-hypertensive and mildly hypertensive adults. Subjects will~     take 2 lozenges per day 12 hours apart for 8 weeks. Half of the subjects will receive Neo40~     Daily® and the other half of the subjects will receive placebo.~   "
67822|NCT02679183|"~     Honey is a natural product that contains multiple nutrients; it is composed of fructose,~     glucose and fructooligosaccharides that can potentially serve prebiotic functions. It also~     contains more than 180 substances including amino acids, vitamins, minerals and enzymes.~     Investigators hypothesized that supplementation of enteral feeds with honey would produce a~     bifidogenic effect and stimulate the immune response in preterm infants. Investigators~     randomly assigned subjects to 4 groups receiving 0, 5, 10 and 15 grams of honey daily for 2~     weeks and measured their effect on stool colonization, systemic immune parameters and~     anthropometric measurements.~   "
67823|NCT02679170|"~     Prospective Observational Study To Identify Patients With Advanced/metastatic Non Small Cell~     Lung Cancer (NSCLC) And ALK Translocation And To Establish Their Therapeutic Management under~     clinical practice (IDEALK)~   "
67824|NCT02679157|"~     Title: PROGnostication of need for REhabilitation and Special Support after Intensive Care~     Unit Stay - a multinational, observational study~      Objectives:~        1. To investigate associations between potential risk factors (premorbid factors, in-ICU~          treatments/diagnoses and patient status at ICU discharge) and three-month physical and~          psychological outcome in ICU survivors.~        2. Based on the associations between identified risk factors and adverse outcomes, create~          and validate instruments, to be used at ICU discharge, predicting new-onset physical or~          psychological problems three months after ICU discharge.~      Study design:~      Prospective, observational multi centre (10 centres) cohort studies~      Outcomes:~      Adverse psychological outcome three months after ICU discharge (Posttraumatic Stress~     Syndrome-14 (PTSS-14) part B score >45 or Hospital Anxiety and Depression Scale (HADS)~     subscale score >10). New-onset physical disability, defined as a reduction in Barthel Index~     ≥10 points compared with 2 weeks prior to hospital admission.~      Study duration:~      Recruitment of patients during 2-4 months in the ten study sites. Follow-up of primary~     endpoints 3 months after ICU discharge.~      Number of subjects:~      The aim is to screen all eligible patients and include 600-1000 ICU survivors during the~     recruitment period. The final number of included patients depends on case-mix in the units~     and potential exclusions.~      Population:~      Adult patients (18 years or older) discharged from ICU.~   "
67825|NCT02679144|"~     Difluoromethylornithine (DFMO) will be used in an open label, single agent, multicenter,~     study for patients with neuroblastoma in remission. In this study subjects will receive 730~     Days of oral difluoromethylornithine (DFMO) at a dose of 500 to 1000 mg/m2 BID on each day of~     study. This study will focus on the use of DFMO in high risk neuroblastoma patients that are~     in remission as a strategy to prevent recurrence.~   "
67826|NCT02679131|"~     A phase I, open-label, nonrandomized study to determine the PK profile of belinostat in~     patients with relapsed/refractory solid tumors or hematological malignancies in patients with~     renal impairment. Eligible patients will be assigned to 1 of 4 cohorts (A, B, C or D) based~     on their level of renal function (normal, mild, moderate, or severe renal impairment) and~     receive belinostat dose A for normal or mild renal impairment, and dose B for moderate or~     severe renal impairment.~   "
67827|NCT02679118|"~     This study will determine the ability of the device to draw a small amount of gas from an~     insufflated abdomen during laparoscopic surgery and accurately detect if gaseous content from~     the bowel is present.~   "
67828|NCT02679105|"~     The study evaluates the safety and effect of intralymphatic allergen specific immunotherapy~     in increasing doses. Patients that have already undergone subcutaneous immunotherapy will be~     treated with three intralymphatic injections in increasing doses; 1000 SQ-U, 3000 SQ-U and 10~     000 SQ-U, or placebo.~   "
67829|NCT02679092|"~     Dilation and evacuation (D&E) is a common surgical procedure in the U.S. Adequate~     pre-operative preparation of the uterine cervix is an important part of preventing~     complications of the procedure. Traditionally, the uterine cervix is prepared for the~     procedure using water-attracting dilators, which are placed via a speculum exam and cause~     discomfort for many women. The objective of this study is to investigate the comparative~     effectiveness of mifepristone (an oral tablet) versus dilators for cervical preparation for~     D&E.~   "
67830|NCT02679079|"~     Phase 2, double-blind, placebo-controlled study to assess the safety and efficacy of~     NBI-98854 administered once daily (qd) for a total of 6 weeks of treatment. This study will~     enroll approximately 90 male and female pediatric subjects clinically diagnosed with Tourette~     Syndrome.~   "
67831|NCT02679066|"~     There is no consensus regarding the need to immobilize the elbow in immediate immobilization~     of closed distal radius fractures post-reduction. Decreased functionality of the upper~     extremity is a notable morbidity associated with below-elbow splinting of distal radius~     fractures post-reduction. Few studies have provided evidence comparing sugar tong splinting~     versus short-arm casting as methods of immediate post-reduction immobilization. The study~     will randomize patients with close distal radius fractures to short forearm casting versus~     sugar tong splinting with close follow up including radiographic and clinical evaluation.~      This will provide guidance regarding the need for short forearm cast immobilization versus~     sugar tong splinting in early maintenance of reduction of closed distal radius fractures, as~     well as functional effects of sugar tong splinting versus short forearm casting.~   "
67832|NCT02679053|"~     The aim of the study is to evaluate the effect of 6 weeks of aerobic endurance exercise as~     adon treatment for moderately to severely depressed inpatients. Endpoints are symptom~     severity, psychological variables, cognitive symptoms, sleep, hypothalamic-pituitary-adrenal~     axis (HPA-axis), Brain-derived neurotrophic factor (BDNF) and heartrate variability (HRV).~      Amendment 1 (Nov. 2016): additional evaluation of TNF-alpha at baseline, +2 weeks and post~     (+6weeks) in already existing blood samples.~   "
67858|NCT02678715|"~     This observer-blind crossover intervention study aims to determine the most effective type of~     device as oral mouthguard in modified-Electroconvulsive Therapy (m-ECT) comparing three types~     of devices: standard, prefabricated and manufactured in the dental laboratory.~      Patients from the ECT Unit of Psychiatric Department of the University Hospital of Bellvitge~     will use the three devices at a random sequence during the twelve treatment sessions, so each~     device (A, B, C) will be used for two weeks, that is, for four consecutive sessions.~   "
69398|NCT02658591|"~     The investigators hypothesized that consuming crackers enriched with faba bean fractions~     (faba bean protein concentrate, faba bean protein isolate, faba bean flour and faba bean~     starch), would reduce the blood glucose response to the meal compared to a crackers without~     faba bean components and reduce food intake at a meal~   "
67833|NCT02679040|"~     At present, it is widely admitted not proposing immediate mammary reconstruction when an~     adjuvant radiotherapy is indicated because of the significant change of the cosmetic result~     (profit) and it whatever is the technique of reconstruction adopted. This is true all the~     more as it is about a reconstruction by prosthesis because of the prothetic died risk of~     hull(shell).~      Teams proposed immediate mammary reconstructions to expanding (carrier) patients of carcinoma~     infiltrating, sometimes locally moved forward. For these patients, was not brought~     back(reported) by increase of the risk of local or remote relapse.~      Two studies estimated afterward the feasibility of the mastectomy with immediate mammary~     reconstruction at the close of the chemotherapy and of the radiotherapy. The rate of~     morbidity is judged as acceptable. The rate of local second offense(recurrence) was similar~     to the patients benefiting from the classic therapeutic plan.~      During an other study ( M-RIC), it was shown that the inversion of therapeutic sequence is~     possible and that by prescribing the chemotherapy and the radiotherapy before immediate~     mammary reconstruction, the morbidity is acceptable.~      It is acquired that the chemotherapy néoadjuvant is equivalent to the post-operative~     chemotherapy as regards the global survival.~      On the other hand, the rate of histological answer, according to subgroups, is very~     different. This rate can vary of 9 % for tumors RH +, negative Her2 in 45 % for tumors RH-,~     Her2 over expression. There are 33 % for the RH +, Her2 + and of 35 % for triple-negative.~      The purpose of the investigators study is to estimate the rate of histological response~     during the inversion of therapeutic sequence to make sure of the oncologic safety(security),~     in particular by molecular subgroups, considering the heterogeneousness of the~     results(profits) after chemotherapy néoadjuvant only. Sataloff and Chevallier Classifications~     is the references and will be used here, but the investigators can also use Symmans~     classification in addition.~      The rate of local and metastatic second offenses(recurrences) will also be estimated.~   "
67834|NCT02679027|"~     Objectives: The aim of study is to determine the possible usage of tongue movements out of~     the mouth in the prediction of difficult intubation.~      Method: Two hundred twenty three patients undergoing abdominal surgery with general~     anesthesia between 2014 and 2015 were enrolled in this study. Difficult intubation was~     evaluated using the intubation difficulty scale (IDS) score. All intubations were performed~     by anesthesiologist to eliminate the differences among the anesthesiologists' experiences.~     IDS score were evaluated by anesthesiologists who had no idea about the measurements of the~     tongue movements and performed laryngeal intubation in all patients.~      To define the tongue movements, horizontal lines were used. Horizontal line were passing~     through the mid points of mandible and upper lip height. Patients were asked to protrude~     tongue maximally and upward (PTMU), to protrude tongue maximally and downward (PTMD) in~     anatomical neutral position which was sitting down on a chair.~   "
67835|NCT02679014|"~     A randomized, double-blind, placebo-controlled, two treatment, parallel group study to~     investigate the effects of RO5459072, a cathepsin S inhibitor, on the immune response to a~     gluten challenge in volunteers with celiac disease. Volunteers with previously diagnosed~     celiac disease will be randomized to receive either 100 milligrams (mg) RO5459072 or placebo~     twice daily with food for 28 days (Days 1 to 28).~   "
67836|NCT02679001|"~     This six months non-interventional, observational, post-marketing, multi-center and local~     study will evaluate the differences in the use of corticosteroids between RA participants~     receiving TCZ or a TNF-inhibitor, in participants who have discontinued the use of a~     TNF-inhibitor as their first biological treatment.~   "
67837|NCT02678988|"~     The study consists of an eligibility screening period, two study periods involving single~     doses of tocilizumab (TCZ) according to an open-label, randomized, two-period crossover~     design with an interval of 6 weeks between periods, and a 6 week follow-up period. Healthy~     participants will receive a single subcutaneous (SC) injection of TCZ via a pre-filled~     syringe-needle safety device (PFS-NSD) and a single injection via an autoinjector (AI). The~     total duration of the study is up to 16 weeks from screening to follow-up. After screening,~     eligible participants will be randomly assigned to one of the two possible treatment~     sequences (Sequence 1: AI-1000 G2 followed by PFS-NSD or Sequence 2: PFS-NSD followed by~     AI-1000 G2) and assigned to one of three injection sites (1: abdomen, 2: thigh, or 3: upper~     arm). All participant groups will receive a total of two TCZ administrations each.~   "
67838|NCT02678975|"~     Disulfiram (Antabuse®) is a well-tolerated, cheap, generic drug that has been in use since~     the 1950s to treat alcoholism. There is now an increasing amount of independent preclinical~     data to support disulfiram as an anticancer agent. The potency of disulfiram as an anticancer~     agent seems strengthened by copper.~      The investigators aim is to investigate disulfiram and copper-supplement as add-on treatment~     in glioblastoma patients with recurrence receiving alkylating chemotherapy.~   "
67839|NCT02678962|"~     The purpose of this study is to compare and evaluate the clinical outcomes of 6 kinds of~     Multifocal Intraocular Lenses: SN6AD1, SBL-3, LS-313 MF30, AT LISA tri 839 MP, ART, LS-313~     MF30T.~   "
67840|NCT02678949|"~     The multiple breath washout (MBW) is one of pulmonary function test that displays flow and~     gas concentration plotted against time, and shows an exponential decay in end-tidal gas~     concentration (washout curve). A number of of indices to describe the washout curve have been~     proposed, the most commonly reported is the Lung Clearance Index (LCI). This is a simple~     measure of ventilation heterogeneity derived from MBW, that can be used after challenge with~     a short action bronchodilator and in response to inhaled steroids, both in the conductive~     airways as acinar. Patients with moderate and severe asthma are characterized by an~     abnormality in both, conductive and the acinar airway. Therefore the following research~     question could be: what are the abnormalities in the heterogeneity of ventilation in children~     with mild and moderate asthma, with respect to the healthy population measured by MBW, and~     whether these alterations persist after challenge with inhaled steroids and B2 agonists~     short-acting.~   "
67841|NCT02678936|"~     Anal fistula is a very common disease with a high impact on life quality. The only commonly~     accepted treatment option is surgery. A wide range of operations and techniques have been~     developed all suffering from a relatively high recurrence rate.~      The investigators propose the combination of the mucosal advancement flap with application of~     platelet-rich plasma (PRP) in the fistulectomy site. This study aims to test the hypothesis~     that by applying PRP the healing rate of complicated anal fistulas can be improved in~     comparison to a control group where the operation is performed without addition of PRP.~   "
67842|NCT02678923|"~     This study will be a proof-of-concept, placebo-controlled, double-blind, randomized trial in~     participants with a recent acute coronary syndrome (ACS) to evaluate the efficacy,~     pharmacokinetics, safety, tolerability, disease progression measures by IVUS, and~     pharmacodynamics of MDCO-216 infusion. Eligible participants will be randomized to receive 5~     infusions of MDCO-216 20 milligrams/kilogram (mg/kg) or placebo in a 1:1 ratio.~   "
67878|NCT02678455|"~     The purpose of this study is to evaluate the safety and immunogenicity of the recombinant~     live attenuated tetravalent dengue virus vaccine admixture TV005 (TetraVax-DV T005) in~     healthy adults, adolescents, and children in Dhaka, Bangladesh.~   "
67843|NCT02678910|"~     The purpose of this research is to obtain ovarian tissue from female participants who will~     receive therapy which is expected to result in a loss or impairment of ovarian function~     and/or infertility and wish to preserve (freeze) ovarian tissue for the purpose of initiating~     a pregnancy in the future.~      Removal of the ovary for cryopreservation is an investigational procedure. 100% of the tissue~     will be used for the participant's future use. There have been 86 pregnancies as a result of~     frozen ovarian tissue that has been re-implanted back into the pelvis and hormonal function~     has been restored in individuals for up to 7 years.~      By doing this study, the investigators hope to learn of how to successfully freeze and thaw~     ovarian tissue in a manner that permits subsequent use by patients at some point in the~     future. Participation may also advance our knowledge of how to successfully mature follicles~     and oocytes (eggs) that are contained in these tissues which may help others in the future.~   "
67844|NCT02678897|"~     In this two-parted study the need and sufficiency of analgesics and experienced pain is~     compared between teen-aged and adult women undergoing medical termination of pregnancy~     (MToP)in early pregnancy (under 9weeks of gestation). During MToP at pregnancy weeks 9-20~     on-demand administration of opiates and patient-controlled analgesia (PCA) are compared in~     randomized clinical trial.~   "
67845|NCT02678884|"~     The purpose of this study is to see how useful the information provided from Positron~     Emission Tomography (PET) scans can be in the actual planning and delivery of radiation~     treatment to patients who have head and neck cancers. Patients participating in this study,~     will have (in addition to their routine tests) a PET scan before and during their radiation~     treatment. Following the intervention, patients will be followed as per standard practice.~   "
67846|NCT02678871|"~     Atrial fibrillation (AF) is a common comorbidity of patients candidates to transcatheter~     aortic valve implantation (TAVI). The management of chronic oral anticoagulation (OAC) for~     the prevention of ischemic stroke is very challenging in this population of complex and frail~     subjects. Since the percutaneous left atrial appendage (LAA) closure with the WATCHAMN device~     proved promising safety and efficacy results in randomized comparisons with OAC (current~     standard of care), the aim of the current study is to assess the feasibility and the early~     safety of performing TAVI with the Lotus System and percutaneous LAA closure with the~     WATCHMAN device at the same session.~   "
67847|NCT02678858|"~     The ISST study investigates whether integrated social cognitive remediation and social~     behavioral skills therapy is more efficacious in improving functional outcome and treatment~     adherence than an active control treatment comprising drill-and-practice oriented~     neurocognitive remediation.~   "
67848|NCT02678845|"~     The purpose of this study is to determine whether treatment of patients with depression~     according to the Collabri Model is more effective in reducing symptoms compared to treatment~     as usual (TAU)~   "
67849|NCT02678832|"~     The study, investigates the current physical activity promotion practices among physicians~     and nurses, as well as social norms toward physical activity during treatment among cancer~     patients and among physicians and nurses who treat or counsel cancer patients.~      For this purpose, four large surveys with health care professionals (specialized~     practitioners, N=300; general practitioners, N=300; oncology nurses, N=300) and cancer~     patients (N=1200, 400 patients each with breast, prostate or colorectal cancer) with a~     cross-sectional research design are conducted.~      Additionally, a follow-up-study with a sub-sample of cancer patients (N=180) will be~     conducted.~   "
67850|NCT02678819|"~     The purpose of this study is to determine whether a wearable digital cognitive aid has an~     effect in the management of simulated crises in anesthesia or intensive care.~   "
67851|NCT02678806|"~     Hepatocellular carcinoma is one of ten leading cancer types worldwide and also in Asia, but~     the five-year relative survival rate is relatively quite low1-3. For hepatocellular carcinoma~     treatment, current options are surgical resection, embolization chemotherapy, radiation~     therapy, a variety of ablation therapy, biological and gene therapy, etc. Among them, the use~     of radiation therapy is getting more and more attention, and it is changing from the past~     palliative treatment to current curable treatment. From an oncologic point of view, a narrow~     margin <1 cm and microvascular invasion is not safe and is often associated with higher rates~     of recurrence and shorter patient survival.On the other hand, it is also believed that most~     intrahepatic recurrences arise from multicentric carcinogenesis and are distant from the~     resection margin. To address this issue, the investigators are going to conduct a series of~     retrospective and prospective studies to investigate the effect of adjuvant Radiotherapy for~     centrally located hepatocellular carcinoma after narrow margin (<1 cm) hepatectomy on tumor~     recurrence.~   "
67852|NCT02678793|"~     Subjects who have completed study 4975-MN-202 will be eligible to receive open-label~     treatment with CNTX-4975 200 µg in study 4975-MN-203 if they meet the inclusion/exclusion~     criteria.~   "
67853|NCT02678780|"~     This is a prospective, international, multi-center, open label, stratified, exploratory phase~     II study evaluating the efficacy and safety of lenvatinib in patients with~     advanced/metastatic, neuroendocrine tumors of the pancreas after progression to a previous~     targeted agent (cohort A) or gastrointestinal tract after progression to somatostatin~     analogues (cohort B).~   "
67854|NCT02678767|"~     This project will investigate the ability of a novel MRI contrast agent to identify and~     quantitate ongoing monocyte/macrophage (M/MΦ)-mediated inflammation in the brains of~     HIV-infected individuals.~   "
67855|NCT02678754|"~     This data collection Registry is a multi-center, observational outcomes Database designed to~     collect data on the demographics, presentation, diagnosis, treatment, resource use, quality~     of life and outcomes of subjects utilizing Caris Molecular Intelligence™ Services for~     treatment of solid tumor cancer.~   "
67856|NCT02678741|"~     Assess the safety and tumor response of utilizing an autologous tumor lysate,~     particle-loaded, dendritic cell (TLPLDC) vaccine given in combination with standard of care~     (SoC) checkpoint inhibitors (CPI) in patients with stage IV melanoma with measurable disease.~   "
67857|NCT02678728|"~     Dexmedetomidine has been known to protect the lung against inflammation and oxidative stress~     in diverse clinical settings. The investigators aimed to investigate the lung protective~     effect of dexmedetomidine in patients undergoing thoracic aortic surgery with hypothermic~     circulatory arrest, which is associated with systemic inflammatory response, and oxidative~     stress.~   "
67859|NCT02678702|"~     Participants (N=48) are patients with major depression. Participants are assessed with~     clinical interview, polysomnographic evaluation and screening with Insomnia Severity Index~     (ISI), Dysfunctional Beliefs About Sleep-scale (DBAS), HDRS, MINI and Sleep Diary pre and~     post treatment.~      Participants are randomly assigned to either treatment as usual or CBT-I. The latter receives~     individual as well as group therapy with CBT-I during 6 sessions.~      Post-treatment: The investigators will compare changes in polysomnographic measures, sleep~     diary parameters, HamD17, ISI and DBAS. Data are analyzed by using Chi-square test,~     Wilcoxon-Mann-Whitney U-test and ANOVA. STATA is used for data-processing.~   "
67860|NCT02678689|"~     This Phase 2 open-label, multicenter study will evaluate the safety, tolerability, and~     efficacy of BMN 190 intracerebroventricular (ICV) administration every other week (qow) for a~     period of 96 weeks, in patients with CLN2. The study is designed to assess disease~     progression in CLN2 patients treated with BMN 190 compared to natural history data from~     untreated historical controls.~   "
67861|NCT02678676|"~     The purpose of this study was to investigate the mortality and macrovascular morbidity as~     well as the incidence of malignancies over time, in high-risk diabetic participants who~     previously received long-term treatment with either pioglitazone or placebo in combination~     with their usual medication for glycaemic management.~   "
67862|NCT02678663|"~     Complete resection of neoplastic polyps is pivotal, as 8.8% to 50% of interval cancers may~     arise as a consequence of incomplete polypectomy. However, the ideal method to remove small~     colorectal polyps remains uncertain. The investigators designed a randomized controlled trial~     to assess whether injection-assisted cold snare polypectomy may be noninferior to EMR for the~     resection of small (6-10mm) colorectal polyps.~   "
67863|NCT02678650|"~     It has been reported that volatile anesthetics preconditioning mediates protection of organ~     via microRNA. We want to study on the effects of isoflurane preconditioning on expression of~     microRNA and mRNA in the specimens of internal mammary artery and ascending aorta.~   "
67864|NCT02678637|"~     Mitochondrial disorders are a group of inherited disorders causing malfunctional~     mitochondria. Mitochondria are found in every cell of the body, and the disorders therefore~     give symptoms from every tissue, especially those with high energy needs as the brain, heart~     and muscles. The disorders are highly disabling.~      The aim of the study is to investigate the relation between muscle strength and contractile~     cross sectional area (CCSA) in the leg of patients affected by mitochondrial diseases. The~     hypothesis is that there can be a disrupted relationship between strength and CCSA.~   "
67865|NCT02678624|"~     The purpose of this study is to determine whether treatment of patients with anxiety~     according to the Collabri Model is more effective in reducing symptoms compared to treatment~     as usual (TAU)~   "
67866|NCT02678611|"~     This study will investigate the safety, tolerability and potential health benefits of the~     dietary supplement, Basis. There will be two doses of Basis compared to a placebo. One third~     of subjects will receive the low dose Basis, one third will receive the higher dose Basis and~     one third will receive placebo.~   "
67867|NCT02678598|"~     The objective of this study is to evaluate the efficacy of intravenous micafungin for the~     empirical antifungal therapy, pre-emptive antifungal therapy, diagnostic driven antifungal~     therapy or targeted antifungal therapy patients with invasive fungal infections caused by~     Candida sp. or Aspergillus sp. (fungemia, respiratory mycosis, gastrointestinal mycosis) in~     adult patients in China.~   "
67868|NCT02678585|"~     The effect of addition of nalbuphine to lidocaine in intravenous regional anesthesia~   "
67869|NCT02678572|"~     This study will evaluate two groups of patients who have melanoma that has spread from the~     eye to the liver: one group (50%) will get high-dose chemotherapy delivered specifically to~     the liver, while the other group (50%) will get one of 4 standard best alternative care~     treatments. Patients in each group will get repeating cycles of treatment until the cancer in~     the liver advances and will be followed until death. This study will evaluate the effect of~     the treatments on how long patients live and how long it takes for the cancer to advance or~     respond to the treatment.~   "
67870|NCT02678559|"~     The principal aim is to assess impact of alveolar recruitment manoeuvres (ARM) on stroke~     volume variation, evaluated by trans-oesophageal echocardiography (TEE). These variations~     will be measured on preload dependency or preload independency status. The principal purpose~     is to determine if variations of stroke volume during standardized ARM can predict the~     preload dependency status.~   "
67871|NCT02678546|"~     Several questionnaires have been developed for clinical research in Traditional Chinese~     Medicine. The objective of this study is to evaluate the consistency and relevance of two~     questionnaires, the Constitution in Chinese Medicine Questionnaire (CCMQ) and the Body~     Constitutions Questionnaire (BCQ).~   "
67872|NCT02678533|"~     The purpose of this study is to assess the feasibility of Plerixafor used in combination with~     G-CSF (Granulocyte Colony Stimulating Factor) in 5 Fanconi anemia patients to mobilize and~     collect a sufficient number of peripheral blood CD34+ cells for peripheral blood apheresis,~     for further gene therapy study.~   "
67873|NCT02678520|"~     Compare the incidence of acute rectal, bladder and other acute toxicities between 3-D~     Conformal Radiation Therapy (RT/CRT) and Intensity Modulated Radiation Therapy (IMRT) in~     Post-Prostatectomy Prostate Cancer Patients treated with post-operative radiation therapy~   "
67874|NCT02678507|"~     The purposes of this study are to evaluate the validity and reproducibility of the POMAQ to~     identify opioid abuse and misuse behaviors among participants who have chronic pain which~     requires long-term opioid use.~   "
67875|NCT02678494|"~     A study examining the effectiveness of neurofeedback therapy for the treatment of Central~     Neuropathic Pain (CNP), in patients with a Spinal Cord Injury, using a small user-friendly~     device which can be operated by patients at home.~   "
67876|NCT02678481|"~     To compare prostate cancer (PCa) detection rate of magnetic resonance (MR)-targeted biopsy~     and transrectal ultrasound (TRUS)-guided biopsy in patients with high PSA values and at least~     one previous negative prostate biopsy. Subjects will be submitted to a multiparametric MR~     scan of the prostate and subsequently patients with a suspicious MR for PCa presence will be~     randomized (1:1) into the two study arms.~   "
67877|NCT02678468|"~     To evaluate the effect of early vision screening with automated photorefraction device in~     high risk children~   "
67879|NCT02678442|"~     This is a clinical trial to compare two needles used in biopsy techniques to acquire tissue~     from pancreatic cancer. The hypothesis is that the tissue yield, as measured by tumor DNA and~     cellular material is superior for Flexible Needle Biopsy (FNB) compared with conventional~     Fine Needle Aspiration (FNA). Specifically, FNB will increase the proportion of cases in~     which sufficient DNA is obtained to allow genomic profiling and whole exome sequencing.~   "
67880|NCT02678429|"~     Programming Deep Brain Stimulation for the treatment of Essential Tremor can be a time~     intensive process. Using an atlas created using functional tremor responses in the operating~     room to determine the optimal settings would lead to a faster response for the patient and~     improved quality of life.~   "
67881|NCT02678416|"~     Compare reduction in pain intensity provided by IV or oral acetaminophen using UVB pain model~   "
67882|NCT02678403|"~     Purpose: The investigators team recently carried out a proof of concept study testing the~     efficacy of one single 45-minute session of 10 Hz TENS prior to walking, versus placebo. In~     this randomized study, the investigators found that TENS significantly delayed pain onset and~     increased the pain-free walking distance in patients with class II PAD. From these~     encouraging results, the investigators now seek to assess the efficacy of an intervention~     that includes the daily use of TENS for 3 weeks (5 days a week) on walking distance in PAD~     (Leriche-Fontaine stage II). Methods/Design: prospective multicentre study / randomized~     controlled trial / double blinding.~   "
67883|NCT02678390|"~     The aim of this study is to compare the effect on ketone production of dietary an MCT~     supplement combined or not with physical exercise in two groups of women (N=10/group),~     healthy adults and patients with prediabetes. After an evaluation of the metabolism (a 4-hour~     visit with multiple blood samples) at the beginning of the study, all the participants are~     taken for one-week the MCT supplement alone follow by a one-week period of taking the MCT~     supplement in combination with physical exercise. At the end of each period of time, the~     4-hour visit for the evaluation of the metabolism is repeated.~   "
67884|NCT02678377|"~     This double-blind randomized controlled trial seeks to find a better treatment for women with~     mixed urinary incontinence (both stress and urgency incontinence). The primary aim is to~     determine whether midurethral sling surgery combined with injections of onabotulinumtoxinA~     (Botox®) into the detrusor muscle of the bladder improves symptoms of mixed urinary~     incontinence better than sling surgery alone.~   "
67885|NCT02678364|"~     While there have been a considerable number of studies on the impact of additional vitamin D~     in the diets of hens on the resulting egg vitamin D content, the effect of consumption of~     such vitamin D-enhanced eggs on vitamin D status of healthy human subjects has not been~     tested in a RCT.~   "
67886|NCT02678351|"~     This phase II/III trial studies gallium 68 Ga (68Ga)-prostate-specific membrane antigen~     (PSMA) positron emission tomography/magnetic resonance imaging (PET/MRI) in finding tumors in~     patients with prostate cancer undergoing surgery that tend to spread quickly~     (intermediate-risk) or is likely to come back or spread (high-risk). Diagnostic procedures,~     such as PET/MRI, may help find and diagnose prostate cancer and find out how far the disease~     has spread. Radioactive drugs, such as gallium Ga 68-PSMA, binds to tumor cells that have~     specific receptors, and may allow doctors to see smaller tumors than the standard of care~     contrast-enhanced computed tomography (CT) or MRI scan.~   "
67887|NCT02678338|"~     This phase I trial studies the side effects and best dose of anti-cluster of differentiation~     (CD)47 monoclonal antibody Hu5F9-G4 in treating patients with haematological malignancies~     including acute myeloid leukemia that has returned after a period of improvement (relapsed)~     or has not responded to previous treatment (refractory), or high risk myelodysplastic~     syndrome. Monoclonal antibodies, such as anti-CD47 monoclonal antibody Hu5F9-G4, block cancer~     growth in different ways by targeting certain cells.~   "
67888|NCT02678325|"~     The objective of this study is to compare the difference in daily protein intake of~     critically ill patients in two standardized enteral nutrition formulas (20% versus 33%~     percent) with the same caloric density of 1.2 kcal/ml.~      The total amount of protein taken in on day four after starting the early enteral feeding is~     defined as primary endpoint.~   "
67889|NCT02678312|"~     This study consist of two parts (Part 1 and Part 2). The purpose of Part 1 is to evaluate the~     way the body absorbs, distributes and removes the drug LCZ696. This will help determine the~     proper dose of LCZ696 for Part 2 of the study.~      The purpose for Part 2 is to compare the effectiveness and safety of LCZ696 with enalapril in~     pediatric heart failure patients over 52 weeks of treatment.~   "
67890|NCT02678299|"~     This is a phase 1/2 open label study to assess the safety and efficacy of pixantrone in~     combination with bendamsutine, etoposide and , for CD20 positive B-cell lymphomas, rituximab~     (P[R]EBEN), in patients with relapsed aNHL of B- or T-cell phenotype.~   "
67891|NCT02678286|"~     The primary objective of this study is to evaluate the analgesic efficacy of N1539 in~     subjects with acute moderate to severe pain following abdominoplasty surgery.~   "
67892|NCT02678273|"~     The investigators will provide an integrated community of care to a socioeconomically~     disadvantaged population. This included an extended cycle of care from tertiary care to~     primary care and linkages with social care agencies in the community.~   "
67893|NCT02678260|"~     The purpose of this study is to characterize the safety, tolerability, Pharmacokinetics (PK),~     and antitumor activity of PDR001 administered intravenous (i.v.) as a single agent to~     Japanese patients.~   "
67894|NCT02678247|"~     The overall objective of this study is to provide a more comfortable and functional~     prosthetic socket for persons with transfemoral amputation that will ultimately improve their~     quality of life.~   "
67895|NCT02678234|"~     The purpose of the study is to assess the short term efficacy of the Theraflu Aktiv powder~     for oral solution in the Russian population as compared to an untreated group to support the~     indication of Short term relief of the symptoms of colds, chills and influenza, including~     mild to moderate pain, fever and nasal congestion.~   "
67916|NCT02677961|"~     Translational studies in cancer research can be impeded by the lack of high-quality clinical~     data that can be correlated with research questions. This is particularly true in the case of~     rare diseases, such as bone and soft tissue tumors. It is therefore the purpose of this study~     to create a prospective EHR-based clinical registry for individuals with bone and soft-tissue~     tumors.~   "
67896|NCT02678221|"~     Intrauterine growth restriction (IUGR) is defined as fetal abdominal circumference (AC) or~     estimated fetal weight (EFW) < 10th centile. In asymmetrical IUGR the parameter classically~     affected is the abdominal circumference (AC). Fetal growth restriction (FGR) complicates~     approximately 0.4% of pregnancies and severely increases the risk of perinatal morbidity and~     mortality. This is particularly due to premature delivery, both for fetal and for secondary~     maternal indications such as the development of pre-eclampsia.~      Consequence of deficient uteroplacental blood flow, including IUGR, pre-eclampsia, and~     placental abruption have been implicated in more than 50% of iatrogenic premature births. For~     this reason, the problem of severe IUGR forms a substantial portion of the population that~     tertiary care centres care for.~      The effect of early-onset IUGR is particularly significant: of those born alive, less than a~     third will survive their neonatal intensive care unit (NICU) stay without significant~     neurodevelopmental sequelae. Survival rates for severely growth-restricted fetuses very~     remote from term (<28 weeks' gestation) vary from 7% to 33%.~      As these early-onset IUGR children are born very preterm, there are significant risks of~     neonatal mortality, major and minor morbidity, and long-term health sequelae.~      The use of ultrasound Doppler waveform analysis in pregnancies complicated by IUGR suggests~     compromised uteroplacental circulation and placental hypoperfusion. Currently there are no~     specific evidence-based therapies for placental insufficiency and severe IUGR. Non-specific~     interventions include primarily lifestyle modifications, such as reducing or stopping work,~     stopping aerobic exercise, rest at home, and hospital admission for rest and surveillance.~     These interventions, which are not supported by evidence from randomized trials, are used in~     the belief that rest will enhance the uteroplacental circulation at the expense of that to~     the glutei and quadriceps muscles.~      There is evidence from ex vivo and animal models of growth restriction that the~     phosphodiesterase 5 inhibitor sildenafil citrate increases average birth weight and improves~     uteroplacental blood flow (umbilical artery, uterine artery).~   "
67897|NCT02678208|"~     Postpartum hemorrhage is the most common cause of maternal death across the world,~     responsible for more than 25% of maternal deaths annually. Although effective tools for~     prevention and treatment of are available, most are not feasible or practical for use in the~     developing world where many births still occur at home with untrained birth attendants .~     primary postpartum hemorrhage is excessive bleeding from or in the genital tract within 24~     hours of delivery of the fetus which affects the general condition.~      Postpartum hemorrhage is responsible for around 25% of maternal mortality worldwide ,~     reaching as high as 60% in some countries. Postpartum hemorrhage can also be a cause of~     long-term severe morbidity, and approximately 12% of women who survive postpartum~     hemorrhagewill have severe anemia.~      Tranexamic acid is an antifibrinolytic compound which is a potent competitive inhibitor of~     the activation of plasminogen to plasmin. At much higher concentrations it is a~     non-competitive inhibitor of plasmin. The inhibitory effect of tranexamic acid in plasminogen~     activation by urokinase has been reported to be 6-100 times and by streptokinase 6-40 times~     greater than that of aminocaproic acid.~   "
67898|NCT02678195|"~     This clinical trial evaluates the duration of treatment of chest-indrawing pneumonia in~     children. Half the children will receive 3 days of amoxicillin dispersible tablets (DT) and~     then 2 days of placebo, while the other half will receive 5 days of amoxicillin DT.~   "
67899|NCT02678182|"~     To evaluate the efficacy of maintenance therapies following completion of standard first-line~     chemotherapy in patients with locally advanced or metastatic HER-2 positive or HER-2 negative~     oesophago-gastric adenocarcinomas.~   "
67900|NCT02678169|"~     Prospective, single-arm, multicenter, observational registry of the ACE Reperfusion Catheters~     and the Penumbra System in Europe. Consecutive patients presenting within 6 hours from~     symptom onset with an acute ischemic stroke (within the internal carotid artery and internal~     carotid terminus, middle cerebral - M1/M2 segments) due to anterior circulation large vessel~     occlusion (LVO) will be treated using the ADAPT technique with thrombo-aspiration as first~     intention and site routine practice.~   "
67901|NCT02678156|"~     The aim of this Post Market Clinical Follow-up Study is to collect clinical data on the~     performance of Lyoplant® Onlay. To assess the performance of the product, various safety and~     efficacy parameters have been selected.~   "
67902|NCT02678143|"~     The aim of this study is to evaluate the overall safety and feasibility of using~     haploidentical or one antigen mismatch unrelated hematopoietic stem cell transplant (HSCT)~     for adult patients with severe sickle cell disease (SCD) who undergo a non-myeloablative~     preparative regimen consisting of total body irradiation (TBI), cyclophosphamide and~     alemtuzumab (and fludarabine for haplo-SCT only) and graft vs. host disease (GvHD)~     prophylaxis consisting of post-transplant cyclophosphamide (PT-Cy), mycophenolate mofetil~     (MMF), and sirolimus. The investigators anticipate that this approach will expand the donor~     pool and offer a safe and less toxic curative intervention.~   "
67903|NCT02678130|"~     The purpose of this post-approval study is to demonstrate that the InterFuse T modular lumbar~     interbody device is at least equal in safety and efficacy to other (standard of care) TLIF~     devices.~   "
67904|NCT02678117|"~     This study evaluates the effect of giving preoperative adjuvant drug as pregabalin or~     magnesium sulphate or a combination of both drugs to decrease postoperative morphine~     consumption and pain intensity in the first 24 hours in postoperative period . quarter of~     patients receive single dose oral pregabalin 300mg 1 hour preoperatively ,other quarter~     receive single intravenous Magnesium sulphate 50mg per Kg over 200ml saline over 20 minutes~     preoperatively , other quarter receive combination of both drugs , the last quarter receive~     placebo drugs . All patients receive 0.1mg per Kg intravenous morphine sulphate~     intraoperatively~   "
67905|NCT02678104|"~     A prospective randomized parallel trial will be carried out on 100 patients who have~     extraction of single molar tooth. Teeth extractions will be done under local anesthesia. The~     patients will be divided randomly into two parallel groups. Group 1: The patients will start~     using Chlorhexidine mouthwash on the second day of extraction twice daily for 7 days. Group~     2: After extraction, Manuka Honey will be applied topically into the extraction socket.~     Postoperative instructions will be given for all patients in addition to the prescription of~     ibuprofen 600 mg every 8 hours for 3 days.~      Re-evaluation:~      Postoperative day 3: tenderness with probing the socket, empty socket, food debris, halitosis~     and assessment of pain. For group 2, the intra-alveolar application of honey will be~     repeated. Re-evaluation will be repeated in the seventh post-operative day. Acute alveolar~     osteitis, (dry socket) is diagnosed if the patient presented between the 2nd and 4th days~     with pain or tenderness in the socket with probing, empty socket and food debris with or~     without halitosis.~   "
67973|NCT02677220|"~     The aim of this study is to investigate the clinical benefit for patients implanted with the~     Nucleus® CI532 cochlear implant.~      The Nucleus® CI532 has a pre-curved, perimodiolar array, the EA32, which is introduced into~     the cochlea through a straightening sheath.~   "
80095|NCT02518568|"~     The purpose of this study is to investigate the pharmacokinetics of serum iron after a single~     oral administration of 160 mg (2 tablets of 80 mg) V0355 in women with iron deficiency~     anaemia.~   "
67906|NCT02678091|"~     Orbital masses develop at the expense of the orbital structures lacrimal glands, oculomotor~     muscles, optic nerve, meningeal spaces, peripheral nerves, bone wall, orbital fat, lymphoid~     structures or vascular structures. These masses can be tumors, benign or malignant, or~     pseudotumor, mainly represented by specific or non-specific orbital inflammation.~      Pathology is of considerable importance for the diagnosis and the treatment of those masses.~     However, biopsy or surgical resection of the orbital masses is sometimes difficult and~     dangerous outside expert centers.~      The identification of a non-invasive technique for distinguishing tumors from pseudotumors,~     thus avoid in some cases a biopsy, would be a major contribution for the patients.~      Quantitative analysis of the ultrasound exam with doppler of those masses could identify~     diagnostic criteria, especially for the lacrimal gland, easily explorable.~   "
67907|NCT02678078|"~     Characterization of Cancer Tissue Using 3D Biosynthetic Materials. Using liver biopsy from~     stage 4 cancer patients, the investigators will evaluate and characterize the metastatic~     cells.~   "
67908|NCT02678065|"~     The objective of this study is to evaluate the performance of the In.Pact Admiral DEB for the~     treatment of popliteal lesions in comparison with literature results of stent treatment in~     popliteal lesions~   "
67909|NCT02678052|"~     The purpose of this study is to assess the prevalence of major structural birth defects in~     infants of female participants with ulcerative colitis (UC) or Crohn's disease (CD) exposed~     to vedolizumab during pregnancy, compared to participants with UC or CD exposed to other~     biologic agents.~   "
67910|NCT02678039|"~     This is a prospective, randomized, controlled, and single blinded study. All work performed~     at Dartmouth-Hitchcock Medical Center, a tertiary care and level one trauma center for the~     state of New Hampshire with 28 operative suites. 100 patients scheduled to undergo~     thoracotomies are randomized to receive an epidural placed (for postoperative pain control)~     using either a traditional approach by feeling the spine for landmarks or using fluoroscopic~     X-ray guidance. Randomization is blinded to both the anesthesia team caring for the patient~     in the operating room and to one member of the acute pain team who follows the patient after~     surgery and is responsible for evaluating post operative pain control (dermatomal~     distribution of sensory blockade and visual analog scale) and pulmonary function (incentive~     spirometer use). All patients receive a standardized epidural infusion with local anesthetic~     and additional pain medications as needed.~   "
67911|NCT02678026|"~     Cervical cerclage was devised in the 1950's for women with prior early preterm births (PTB)~     who developed a dilated cervix detected by manual exam in the second trimester. In~     contemporary practice, there are three possible indications for cerclage. History-indicated~     cerclage (HIC) is defined as a cerclage placed usually between 12-15 weeks based solely on~     poor prior obstetrical history, e.g. multiple second trimester losses due to painless~     dilatation. Ultrasound-indicated cerclage (UIC) is defined as a cerclage placed usually~     between 16-23 weeks for transvaginal ultrasound (TVU) cervical length (CL) < 25mm in a woman~     with a prior spontaneous PTB. Physical-exam indicated is defined as a cerclage placed usually~     between 16-23 weeks because of cervical dilatation of 1 or more centimeters detected on~     physical (manual) examination.~      Randomized trials and meta-analysis of these have shown that UIC is associated with~     significant reduction in PTB and improved neonatal outcome, whereas evidence of efficacy for~     history-indicated cerclage and physical exam-indicated cerclage is limited. In the United~     States, the national data shows that the rate of cerclage has decreased in the last few~     years. The indications of placement of cerclage have recently changed, and so it is important~     to evaluate how many women are getting this procedure. With the recent completion of clinical~     trials, it is plausible that obstetricians and perinatologists may have become more selective~     in terms of the best candidates for cerclage.~      The aim of this RCT is to evaluate the efficacy of cervical pessary in prevention of PTB as~     adjuctive therapy in women with UIC~   "
67912|NCT02678013|"~     Hepatocellular carcinoma (HCC) is the fifth most common and the third leading cause of~     cancer-related death worldwide. Recurrence of tumor within the liver remnant is common, with~     a reported 5-year recurrence rate of 70%. Repeat hepatectomy is an effective treatment for~     intrahepatic HCC but with a small proportion of resection rate because of the poor functional~     liver reserve and postoperative complications. Radiofrequency ablation(RFA) is becoming the~     main effective treatment for small HCC (≤5.0cm). The efficacy of RFA for recurrent HCC has~     been reported to be comparable to those achieved by surgery with minimal, but higher local~     recurrence rate after RFA. It has been reported that immunotherapy in patients who underwent~     curative treatment for HCC, adjuvant immunotherapy with activated CIK cells increased~     recurrence-free and overall survival. But there is little evidence for adjuvant immunotherapy~     of recurrence HCC. Cytotoxic T lymphocytes(CTL), a kind of effective T cells that specific~     recognizing and killing antigen targeted cells through cloning amplification after receiving~     antigen information from antigen presented cell and playing key role to clear cancerous~     cells. So our hypothesis is that RFA combined with immunotherapy (Highly-purified CTL) is~     superior to RFA for recurrent HCC. The aim of this prospective study is to compare the~     outcome of RFA combined with immunotherapy (Highly-purified CTL) with RFA for small recurrent~     HCC after partial hepatectomy.~   "
67913|NCT02678000|"~     This is a randomized, double-blind, parallel group, placebo-controlled study, in two~     sequential parts to evaluate the renal safety, tolerability and pharmacokinetics of LHW090 in~     patients with moderately impaired renal function.~   "
67914|NCT02677987|"~     Cognitive impairment (such as memory problems) due to cancer and its treatment can interfere~     with quality of life and can linger long after treatment has ended, yet research examining~     cognitive rehabilitation approaches has produced limited clinical benefit. The proposed study~     will provide information about systematic light exposure for the treatment of cognitive~     impairment in hematopoietic stem cell transplant (HSCT) survivors and will investigate how it~     works. This study would facilitate the development of this potential treatment, giving health~     care providers and cancer survivors a much-needed tool to help with cancer-related cognitive~     impairment.~   "
67915|NCT02677974|"~     The purpose of the proposed study is to assess the occurrence of bleeding, valve-related~     thromboembolism and valve thrombosis with the On-X Aortic Prosthetic Heart Valve when~     targeted at an International Normalized Ratio (INR) level of 1.8 (1.5-2.0 range) during a~     5-year follow-up period. The objective will be to compare adverse event rates for patients in~     subgroups as listed below targeted at 1.8 (range 1.5 to 2.0) per On-X instructions for use to~     rates from the previous IDE trial (G050208).~   "
67917|NCT02677948|"~     This study combines two drugs in the treatment of relapsed/refractory chronic lymphocytic~     leukemia (CLL) and small lymphocytic lymphoma (SLL). Investigators are proposing combining~     ibrutinib, an orally-administered, small molecule inhibitor of Bruton's tyrosine kinase (FDA~     approved for the treatment of relapsed/refractory CLL), with pacritinib, a novel JAK2-FLT3~     inhibitor that has shown activity in relapsed lymphoma, including CLL/SLL. Investigators will~     first demonstrate the safety and tolerability of Pacritinib when combined with Ibrutinib in a~     phase I study, which will help establish the MTD (Maximum Tolerated Dose)of Pacritinib when~     combined with Ibrutinib. Once the optimal dose of Pacritinib is established in the phase I~     setting, a phase II evaluation will seek to establish the efficacy of the combination of~     Pacritinib with Ibrutinib. Patients will receive continuous treatment until progressive~     disease and will be followed while on study treatment for a total of 2 years.~   "
67918|NCT02677935|"~     Worldwide, headache disorders are among the most common medical conditions. Many people with~     headache need not experience further pain if the diagnosis and treatment are correct. Most~     patients do not have correct diagnosis and treatment. This study tested a model for treatment~     of people with headache disorders at primary health-care level in rural areas of Haryana,~     India.~   "
67919|NCT02677922|"~     This Phase 1b/2 study is an open-label, randomized, multicenter trial to evaluate the safety~     and efficacy of oral AG-120 + Subcutaneous (SC) azacitidine and oral AG-221 + SC azacitidine~     in subjects with newly diagnosed AML with an IDH1 or an IDH2 mutation, respectively. The~     study population consists of subjects who are not candidates to receive intensive Inductive~     chemotherapy (IC). The study comprises a Phase 1b dose-finding and AG-120 expansion stage and~     a Phase 2 randomized stage.~   "
67920|NCT02677909|"~     In this study, the investigators aim to conduct a pilot test of the AbStats device. The v2.0~     prototype is a low-profile set of sensors that fits externally around the abdomen and is~     embedded with specialized wireless sensors. The device continuously, safely, and comfortably~     monitors intraabdominal acoustic signals, and stores the data in a HIPAA compliant software~     system.~      The investigators will focus this trial on a high-impact inpatient population: ileus in the~     surgical critical care unit. The investigators will compare the device's signal profiles in~     patients with ileus vs those who tolerate feeding without high gastric feed residual. Our~     study will have the following specific aims:~      Specific Aim #1: To measure the sensitivity, specificity, positive predictive value (PPV),~     and negative predictive value (NPV) of initiation day (PID 0) AGIS signals in predicting~     PID #1 feeding failure. Specific Aim #2: Among patients tolerating feeds on PID #1, to~     measure the sensitivity, specificity, PPV, and NPV of AGIS in predicting feeding failure on~     subsequent icu days.~   "
67921|NCT02677896|"~     The purpose of this study is to evaluate the efficacy of enzalutamide plus androgen~     deprivation therapy (ADT) as measured by radiographic progression-free survival (rPFS) based~     on central review. The study will also evaluate the safety of enzalutamide plus ADT in mHSPC.~   "
67922|NCT02677883|"~     This randomized controlled trial attempts to determine whether the measurement of pleural~     pressures during therapeutic thoracentesis affects the development of chest discomfort after~     the procedure. During thoracentesis, pleural fluid is drained from the pleural space,~     resulting in lung expansion. In some cases, the lung is not completely re-expandable, in~     which case continued drainage results in the development of negative pleural pressures and~     chest discomfort. Negative pleural pressures may also result in other complications such as~     re-expansion pulmonary edema and pneumothorax. The identification of negative pleural~     pressures via manometry during the procedure may lead to a reduction in the complication~     rate.~   "
67923|NCT02677870|"~     The purpose of this study is to determine if Amish patients with PKU show responsiveness~     after a high dose, prolonged Saproterin trial. The population of interest has a high~     frequency of a specific splice site mutation, the 1066-11G>A mutation. This splice site~     mutation activates a cryptic splice site resulting in an in frame insertion of 9 nucleotides~     preceding exon 11. This leads to protein conformational changes and abrogation of function.~     Previous studies of this genotype have indicated <1% residual activity of the PAH enzyme and~     an insignificant responsiveness to Saproterin. However, in this specific study Phe levels~     were evaluated only over 24 hours after a single-dose BH4 challenge at the standard dose of~     20mg/kg.~      Based on new clinical information, the investigators hypothesize that if given a prolonged~     trial of Saproterin at a higher dose, Amish patients with PKU, specifically those homozygous~     for the c.1066-11G>A mutation, will have a significant reduction in Phe levels or an increase~     in Phe tolerance and/or improvement in executive functioning and quality of life.~   "
67924|NCT02677857|"~     At this time, no study has examined the effect of a lifestyle intervention with a reduced~     Sedentary Behavior (SB) prescription on overall physical activity, weight loss, metabolic~     dysfunction, and inflammation in breast cancer survivors. Thus, in collaboration with~     University of Tennessee Medical Center's (UTMC) Cancer Institute, investigators propose to~     randomize 30 female breast cancer survivors (history of breast cancer stages I [> 1 cm], II,~     or III) with a body mass index (BMI) between 25 and 45 kg/m2 who are sedentary (engage in > 8~     hours a day of SB) and inactive (engage in < 100 min/wk MVPA) to one of three, 3-month~     conditions:~        1. lifestyle intervention (Lifestyle) (increase MVPA to > 200 min/wk);~        2. lifestyle intervention with a reduced SB prescription (Lifestyle+SB) (increase MVPA to >~          200 min/wk and reduce SB by 2 hrs/day); or~        3. weight management education materials provided via mailed newsletter (Newsletter).~      Lifestyle and Lifestyle+SB will receive a standard dietary (low-calorie [1200-1500 kcal/day],~     low-fat [<30% calories from fat]) prescription that emphasizes intake of fruits, vegetables,~     and whole grains, and a cognitive behavioral intervention to assist with meeting activity and~     diet goals. Dependent variables, measured at 0 and 3 months, include objectively measured SB,~     LPA, MVPA, and total activity via accelerometry; self-reported SB; percent weight loss;~     insulin and glucose, and leptin and C-reactive protein (CRP) (biomarkers of cancer prognosis~     that have been found to be positively related to SB and/or adiposity); diet; body~     composition; and fitness.~   "
67974|NCT02677207|"~     To evaluate the effects of the nicotinic allosteric modulator JNJ-39393406 on psychometric~     performance and residual depressive symptoms in patients who have been diagnosed with~     unipolar and bipolar depression but currently DO NOT meet criteria for an episode of Major~     Depression or Manic Episode.~   "
67925|NCT02677844|"~     The purposes of this study are to determine:~        -  The effect of single increasing doses of the study drug, abemaciclib, on healthy~          participants.~        -  The relationship between the amount of abemaciclib and the electrical tracing of the~          heart rhythm when abemaciclib is given.~        -  How much abemaciclib is found in the bloodstream and how long the body takes to get rid~          of it.~      Information about any side effects that occur will be collected. The study will enroll two~     groups (cohorts) of participants. Each group will complete 4 study periods. This study is~     expected to last about 3 months. Screening may occur up to 28 days prior to enrollment. All~     participants will undergo a follow-up assessment approximately 21 days after administration~     of their final dose of study drug.~   "
67926|NCT02677831|"~     The general aim of this study is to establish a longitudinal cohort of older persons in order~     to examine the physiological, environmental and genetic risk factors for physical disability,~     frailty, cardiovascular disease, and neuropsychiatric disorders in older persons and to~     examine the benefit of healthy lifestyles. The findings from this study will provide~     information necessary for the development of effective health policy for aging people.~   "
67927|NCT02677818|"~     The purpose of this study is to determine whether Plasma Factor VIII Levels are related to~     the treatment of bleeding in ischemic stroke（IS）.~   "
67928|NCT02677805|"~     The aim of this study is to assess the efficacy and safety of BoNT/a-DP in the treatment of~     glabellar lines in comparison with placebo, including efficacy after repeat treatments and~     long term safety.~   "
67929|NCT02677792|"~     The purpose of the current study is examine the feasibility and efficacy of providing a~     behavioral family intervention in 30 youth 10 to 17 years of age who are obese and attending~     a multidisciplinary pediatric obesity clinic and their parents. Participating families will~     complete assessments consisting of weight status, dietary intake, physical activity,~     health-related quality of life, psychological functioning, home-food environment, parenting~     skills, and self-efficacy at pre-treatment (Baseline), post-treatment (Month 3), and 2 month~     post-treatment follow-up (Month 5). Family attendance data will be collected during the~     behavioral family intervention and children and parents will complete a treatment~     satisfaction questionnaire at the post-treatment assessment. Health outcomes (e.g., A1C,~     glucose) routinely assessed through standard medical care in the multidisciplinary pediatric~     obesity clinic will be obtained from child medical charts.~   "
67930|NCT02677779|"~     The study is aimed at comparing debridement either with CO2 laser or traditional surgery in~     patients with infected diabetic foot ulcers. The principal endpoint is bacterial load~     immediately after treatment.~   "
67931|NCT02677766|"~     To date, there are no studies that demonstrate that the intervention of Occupational Therapy~     (OT) in patients considered to be complex, regardless of diagnosis, could improve clinical~     and functional outcome for the patient. For this reason, the investigators propose one~     randomized controlled trial that will compare the group receiving the intervention of OT and~     the control group, to quantify the level of performance and satisfaction in the activities of~     interest of the patient, identified through the COPM. The hypothesis is that the benefit may~     be higher, as clinically relevant, in the group of complex patients treated with the proposed~     intervention of OT compared to those receiving the usual rehabilitation therapy.~   "
67932|NCT02677753|"~     The investigators propose a randomized control trial comparing the rate of implantation of~     the InterStim device following Percutaneous Nerve Evaluation (PNE) performed with or without~     fluoroscopic guidance.~   "
67933|NCT02677740|"~     The aim of this project is to increase our understanding of how two different protocols of~     repetitive transcranial magnetic stimulation (rTMS), inhibitory (1 Hz) and excitatory (5 Hz),~     applied over the primary motor cortex of the presumed dominant hemisphere, affect functional~     connectivity and neurochemistry in the brain.~   "
67934|NCT02677727|"~     This is a prospective observational study investigating the incidence, characteristics of,~     and change in chronic neuropathy symptoms related to cisplatin using the EORTC CIPN-20~     instrument. Approximately 60 patients will be collected for this study. The duration of this~     study will be up to 18 months for each patient. This study will complement a current R01~     funded trial (Platinum Study) which evaluates the genetic predisposition of chronic~     neuropathy after 12 months of chemotherapy. However, although the platinum study evaluates a~     similar patient population, it does not evaluate the natural history of platinum induced~     neuropathy during active treatment and the first 12 months post chemotherapy. This trial will~     fill this gap and add to the investigators knowledge for both natural history and genetic~     predisposition of platinum neurotoxicity.~   "
67935|NCT02677714|"~     The changes to the heart can be evaluated during the course of the chemotherapy with cardiac~     magnetic resonance imaging (CMRI) and left ventricular (LV) nuclear scans to look at left~     ventricular ejection fraction (LVEF). Serial LVEF evaluation can detect cardiotoxicity,~     usually after cardiac damage is present and most likely irreversible. Each patient's~     sensitivity to the chemotherapy is different.~      The study is being done to assess the ability of the radiotracer 99mTc-rhAnnexin V-128 to~     image the cell damage from apoptosis, or cell death, in the heart from the effects of the~     chemotherapy. This may allow doctors to identify patients developing cardiotoxicity in the~     future. These patients may then benefit from changes in chemotherapy with dose alterations or~     changes to alternative drugs.~   "
67936|NCT02677701|"~     This is a study to examine the effect of combining chronic oral azithromycin with inhaled~     tobramycin in adolescent and adult subjects with cystic fibrosis who are chronically infected~     with P. aeruginosa.~   "
67937|NCT02677688|"~     EBV has been implicated in pathogeny of SLE with increase in EBV sero-prevalence, defective~     control in EBV infection and altered both B and T immune responses to this virus The main~     objective of this pilot proof-of-concept (POC) study is to evaluate safety and efficacy of~     autologous EBV specific CTL adoptive transfer in adult patients with serologically active SLE~   "
67938|NCT02677675|"~     The objective of this study was to determine the effectiveness of mobile phone technology~     (SMS and telephone call reminders) in improving adherence and treatment outcomes among HIV~     positive patients on ART in Malaysia.~   "
67975|NCT02677194|"~     The aim of this study is to assess cutaneous healing process under LED exposition on 10~     healthy subjects pre-treated with fractional CO2 laser on mini-zones on forearms.~   "
67939|NCT02677662|"~     Air pollution continues to be a key global issue with many governments focusing great~     attention on air quality legislation because of its harmful environmental and health impacts.~     Whilst there is much that remains unknown about the mechanisms underlying the negative health~     effects of air pollution, it is generally acknowledged that air pollution exposure leads to~     an increase in cardiovascular, cerebrovascular and respiratory mortality and morbidity. The~     current study will investigate systemic effects during a 72 hour period after a controlled~     diesel exhaust exposure.~   "
67940|NCT02677649|"~     Composition and diversity of intestinal microbiota that are subject to the influence of diet~     have a significant impact on health in the gut and whole body via complex interactions~     between food constituents, bacteria, and host. Polyphenols are poorly absorbed in the upper~     gastrointestinal tract and reach the colon, where they may have a reciprocal relationship~     with microbiota. Because how polyphenols mediate gut health and reduce risk for other~     pathogenesis remains to be elucidated, we propose to conduct a pilot controlled feeding study~     to examine the impact of polyphenols and other constituents in the free dried whole cranberry~     powder (FWCP) on composition and diversity of gut microbiota, as well as to substantiate~     bioavailability of cranberry polyphenols. The central hypothesis underlying the proposed~     research is that FWCP polyphenols will diminish the magnitude of a plant food free diet~     induced increase in Alistipes, Bilophila and Bacteroides and will increase Enterococcus,~     Bifidobacterium, Eggerthella lenta, and Blautia coccoides-Eubacterium rectale groups. The~     proposed research is novel as no study has examined the specific impact of FWCP polyphenols~     incorporated into a plant food free diet on gut microbiota. This proposed study is innovative~     because the positive results will demonstrate with a high degree of confidence that the~     impact of FWCP constituents on production of beneficial short chain fatty acids, carcinogenic~     bile acids, and atherogenic trimethylamine. The results generated from the study using a~     plant food free dietary regimen as the background diet will provide definite proof on~     microbial modulating actions of FWCP, inform mechanism of actions in urinary tract infection~     (UTI), and be used to formulate messages in consumer communications for gut health.~   "
67941|NCT02677636|"~     This is a double-blind, randomized, vehicle-controlled, multi-center, parallel group Phase 3~     study of MSRD-100 in the treatment of atopic dermatitis in subjects aged 3 months and up~   "
67942|NCT02677623|"~     Many gynecologic, urologic and pelvic reconstructive surgeries require accurate ways to~     identify the opening of the ureters to ensure that they are working correctly. Historically,~     indigo carmine, an intravenous medication that dyes the urine blue, has been used to help~     visualize the opening of the ureters with cystoscopy which is a camera placed inside the~     bladder. In June 2014, the FDA announced there was current shortage of indigo carmine. Thus,~     investigators need to evaluate other methods for assessing ureteral patency. Ideal~     alternatives are agents that are low-risk, inexpensive, provide comparable visualization, are~     readily available and are easy to use.~      Examples of such agents currently being used to evaluate the ureters, include oral pyridium,~     IV sodium fluorescein, and mannitol. These agents help identify the opening of the ureters by~     either dyeing the urine a different color such as pyridium and sodium fluorescein, or by~     having a different viscosity to urine such as mannitol. This study will compare three methods~     of evaluating ureteral patency at time of cystoscopy compared to no method: mannitol, sodium~     fluorescein, and pyridium.~   "
67943|NCT02677610|"~     This is a double-blind, randomized, vehicle-controlled, multi-center, parallel group Phase 3~     study of MSRD-100 in the treatment of atopic dermatitis in subjects aged 3 months and up.~   "
67944|NCT02677597|"~     Cisplatin Combined With S-1 or Paclitaxel as First-line Treatment for Metastatic Esophageal~     Squamous Cell Carcinoma~   "
67945|NCT02677584|"~     Investigators hypothesized that the timing of caffeine administration in either prophylaxis~     or treatment of apnea of prematurity will affect the apnea response to caffeine~   "
67946|NCT02677571|"~     Purpose to compare paravertebral thoracic block (PVB) and pectorals nerves block as analgesic~     option for major breast surgery.~      102 patients undergoing reconstruction breast surgery will be randomized into two groups:~     Group PVB (n=51) will receive US guided paravertebral thoracic block (between T2-T6)~     performed with 30ml of 0.25% levobupivacaine before general anesthesia (TCI-TIVA) induction.~      Morphine patient control analgesia (PCA) with loading dose i.v. titrated by the PACU nurse if~     pain > 5/10 at rest Group PECS (n=51) will receive US guided pectorals nerves block performed~     with 30ml of 0.25% levobupivacaine before general anesthesia (TCI-TIVA) induction.~      Morphine PCA with loading dose i.v. titrated by the post-anesthesia care unit (PACU) nurse if~     pain > 5/10 at rest~      Primary Outcome Measures:~      Morphine consumption (mg) (Time Frame: 24 hours) in two Groups~      Secondary Outcome Measures:~      Pain at rest and during movement quantified as Numerical Rating Scores (0-10) during the~     first 24 hours postoperatively.~      Eventual side effects such as nausea/vomiting. Time necessary to perform the procedure. Pain~     during procedure execution quantified as Numerical Rating Scores (0-10) Hypnotic and opioids~     intraoperative consumption to ensure general anesthesia with Bispectral Index between 40 and~     60.~   "
67947|NCT02677558|"~     The purpose of this study is to determine the impact of obesity in pregnancy on maternal~     cardiac function. For this, morbidly obese term pregnant women (study group) and term~     pregnant women of normal weight are assessed by transthoracic echocardiography.~   "
67948|NCT02677545|"~     Patients with symptomatic or asymptomatic carotid stenosis in whom carotid artery stenting is~     planned are randomised between antiplatelet therapy with ticagrelor plus aspirin or~     clopidogrel plus aspirin and examined with brain MRI before and after stent treatment. The~     proportion of patients with new ischaemic lesions on MRI after treatment is compared between~     the two groups.~   "
67949|NCT02677532|"~     The aim of the study is to determine wether continuous wound infusion with local anaesthetic~     plus a single dose intravenous morphine is non-inferior to postoperative analgesia provided~     with continuous thoracic epidural infusion of local anaesthetic plus opiate, in patients~     undergoing open abdominal aortic aneurism repair.~   "
67976|NCT02677181|"~     The purpose of this study is to determine the efficacy and safety of combined ATG~     （antithymocyte globulin ） regimen for aGVHD(acute graft-versus-host disease ) prophylaxis in~     matched sibling donor peripheral blood stem cell transplantation (MSD-PBSCT).~   "
67977|NCT02677168|"~     The purpose of this study is to determine whether cNEP (continuous positive external~     pressure) is effective in treating obstructive sleep apnea~   "
67950|NCT02677519|"~     The primary objective of this study is to evaluate the long-term safety and tolerability of~     methylphenidate hydrochloride extended-release capsules (Aptensio XR®) in children aged 4-5~     years who have been diagnosed with attention-deficit/hyperactivity disorder (ADHD).~      Safety and tolerability will be evaluated by assessing treatment-emergent adverse events~     (TEAEs) blood pressure, pulse, height, weight, electrocardiograms (ECGs), laboratory The~     primary objective of this study is to evaluate the long-term (12-month) safety and~     tolerability of Aptensio XR® in children aged 4 to less than 6 years who have been diagnosed~     with ADHD.~      Safety and tolerability will be evaluated by assessing treatment-emergent adverse events~     (TEAEs) blood pressure, pulse, height, weight, electrocardiograms (ECGs), laboratory values~     and Columbia Suicide Severity Rating Scale (C-SSRS). Disturbances in sleep (quantity and~     quality) patterns will also be assessed using the Child Sleep Habits Questionnaire (CSHQ).~      Secondary objectives include assessment of long-term efficacy of Aptensio XR®.~      Secondary measures include:~        -  Investigator administered Attention-Deficit/Hyperactivity Disorder Rating Scale~          Preschool Version (ADHD-RS-IV Preschool Version)~        -  Clinical Global Impressions-Severity Scale (CGI-S )~        -  Connors Early Childhood Behavior-Parent Short form [Conners EC BEH-P(S)]~   "
67951|NCT02677506|"~     This study compares the infraclavicular approach to supraclavicular approach of brachial~     plexus block for elbow surgery.~   "
67952|NCT02677493|"~     This study evaluates the immunogenicity and safety of 'IL-YANG Quadrivalent Influenza Vaccine~     Inj.' in healthy male and female adults at the age of 19 or older.~   "
67953|NCT02677480|"~     The test group consisted of eighteen subjects with hyposalivation used probiotic tablets (≥~     4/day) and gel (once a week) (streptococci, bicarbonate and carbamide) for 3 months and 9~     used placebo tablets and gel. The salivary secretion rates were measured and microbial~     samples collected and analysed using cultivation technique twice both at baseline and at the~     3-month follow up (1-2 weeks between the appointments).~   "
67954|NCT02677467|"~     Investigators examine blood-pressure variance, several cardiovascular risk factors of patient~     with epistaxis. As a result of collected data, investigators look into correlation between~     epistaxis and hypertensive cardiovascular disorder.~   "
67955|NCT02677454|"~     To evaluate the accuracy of the Flash Glucose Monitoring system (FGM), Abbot FreeStyle Libre,~     used today in clinical practice in Sweden in estimating plasma glucose levels. Data will be~     collected in ambulatory patients with type 1 diabetes to determine safety, accuracy, and~     reliability.~   "
67956|NCT02677441|"~     This study will evaluate the non-inferiority of conservative management for acromioclavicular~     clavicle disjunction, compared with surgical management. Half of patients will be treated~     with a specific standardized rehabilitation protocol, and the other half will be treated with~     coracoclavicular and acromioclavicular fixation, followed by a another specific standardized~     rehabilitation protocol.~      Outcomes:~      The primary outcome is the non-inferiority of the conservative management over surgical~     management of Rockwood III-V Acute acromioclavicular joint dislocation (ACJD) without PICCAT~     with American Shoulder and Elbow Surgeons (ASES score) at one year. If the non-inferiority is~     reached, the non-inferiority of the conservative management over surgical the management of~     Rockwood III-V ACJD with PICCAT using ASES score at one year will be evaluated.~      Secondary outcomes were radiological criteria (i.e. comparison of ipsilateral and~     contralateral coracoclavicular distance on anterior view; and dynamic posterior shaft of the~     cross-body adduction Basamania/Alexander view) return to sports, work absenteeism,~     complication rate, cosmetic results, patients satisfaction, Constant score, Single Assesment~     Numeric Evaluation (SANE) score, Acromioclavicular Joint Instability (ACJI) score, ASES score~     at others timepoints, and range of motion of the implicated shoulder. Finally, multivariable~     regression analysis will be performed in order to evaluate the impact of predictors of~     interest on ASES score at one year.~   "
67957|NCT02677428|"~     A significant portion of Veterans who apply for disability benefits have difficulty finding~     and sustaining employment, and are concerned that working for pay will jeopardize their~     receipt of service-connection benefits. In a completed clinical trial, Veterans who received~     Motivational Interview-formatted counseled about opportunities to work and receive~     service-connection went on to work for pay significantly more often than controls. The~     proposed clinical trial will test this counseling's efficacy when it is delivered by an~     automated computer program.~   "
67958|NCT02677415|"~     Recent observational studies have found an association between general anaesthesia and~     increased post-operative mortality in acute ischemic stroke patients undergoing endovascular~     treatment. It is unknown whether there is a causal relationship in this observation. The~     investigators are performing a large randomised trial of general versus local anaesthesia to~     definitively answer the question of whether anaesthetic type alters perioperative outcome.~   "
67959|NCT02677402|"~     Objectives In this study the investigators examined the changes in common femoral vein (CFV)~     and great saphenous vein (GSV) calibre during thermo neutral water immersion (TNI), cold~     water immersion (CWI) and contrast water therapy (CWT).~      Design Ten professional handball players visited the laboratory on three occasions. At each~     visit, participants completed a 20-minutes procedure in an upright position: 4-minutes in air~     (baseline) and then 16-minutes lower limbs TNI (~35°C), CWI (~12°C) or CWT (2:2minutes (~12°C~     to ~35°C) ratio), selected randomly.~      Methods CFV and GVS calibres were evaluated by echo Doppler measures at baseline and at the~     end of 16 min immersion.~   "
67960|NCT02677389|"~     This randomized pilot clinical trial studies how well survivorship care plan works in~     promoting technology-based physical activity in breast or colorectal cancer survivors in~     Wisconsin. A survivorship care plan may help doctors to better understand how they can help~     people who have been diagnosed with cancer to become more physically active. It is not yet~     known whether a standardized cancer survivor plan used as part of routine care or a~     technology-based physical activity intervention is better in promoting physical activity in~     breast or colorectal cancer survivors.~   "
67961|NCT02677376|"~     To determine the feasibility and success rate of tumor tissue procurement using~     molecular-image-directed biopsies of responding and non-responding osseous metastases,~     measured by NaF PET/CT, in patients with metastatic castrate-resistant prostate cancer.~   "
71216|NCT02634801|"~     The main purpose of this study is to evaluate the efficacy of ixekizumab compared to fumaric~     acid esters (FAE) and methotrexate (MTX) in participants with moderate-to-severe plaque~     psoriasis who are naive to systemic treatment.~   "
67962|NCT02677363|"~     Strength training can increase muscle mass and strength while improving bone density and~     reducing risk for osteoporosis and related fractures. Strength training can also lead to~     reduced risk for diabetes, heart disease, arthritis, depression, and obesity; and improves~     self-confidence, sleep and vitality. Research demonstrates that strength training is~     extremely effective in helping aging adults with chronic conditions prevent further onset of~     disease and, in many instances, actually reverse the disease process. In Stay Strong, Stay~     Healthy Program elderly subjects perform resistance exercise training (RET) twice every week.~     Past literature suggests that resistance training improved muscle activity, muscle strength,~     muscle mass, and bone mineral density and total body composition, and adiponectin, insulin~     sensitivity, fasting blood-glucose (BG), HbA1c1 (long-term marker of BG), blood pressure~     (BP), blood triglycerides (TGs) and low density lipoproteins (LDL) in healthy and diabetic~     subjects. The purpose of this study is to measure the changes in the above discussed~     variables after 8-weeks of resistance exercises.~   "
67963|NCT02677350|"~     To evaluate the role of allogeneic mesenchymal stem cells for treatment of perianal~     fistulizing Crohn disease.~      Twenty (20) Crohn's disease patients with complex or multiple perianal or rectovaginal~     fistulas will be included and will be scheduled to undergo peri-fistula injections after~     meeting all inclusion/exclusion criteria's at baseline.~      Following the Pilot Phase of four (4) subjects, sixteen (16) subjects are scheduled to~     undergo perianal injections and after meeting all inclusion/exclusion criteria's, will be~     evaluated at baseline.~   "
67964|NCT02677337|"~     This study will consist of three parts: 1) a retrospective chart review of patients treated~     for mRCC from July 2013 until the start of the educational intervention; 2) an educational~     program for DCN community oncology providers and DCN community patients with mRCC, lasting 8~     - 10 months, and 3) a second retrospective chart review of patients treated for mRCC starting~     at the time of the educational intervention until the intervention is completed.~   "
67965|NCT02677324|"~     This research study is studying a targeted therapy as a possible treatment for relapsed or~     refractory Waldenstrom's Macroglobulinemia (WM). This study is using the study intervention~     ABT-199.~   "
67966|NCT02677311|"~     This is a prospective case control study. Participants will be enrolled as case subjects or~     control subjects, depending upon the gonadotoxicity of their chemoradiation therapy. The~     chemotherapeutic regimens will be determined per standard of care. Participants will receive~     GnRHa (Lupron) as standard of care for menstrual suppression. Blood draws and pelvic~     ultrasound at baseline, 6 months and 12 months post completion of chemotherapy are the~     interventions. The duration of the study will be approximately 12 months.The study time~     includes the time necessary for completion of most cancer treatments in this population,~     which approximates 8-12 months, and time to allow complete excretion of the Lupron from the~     systemic circulation with reliable testing of the hypothalamic pituitary ovarian (H-P-O)~     axis. The results of the study will be used to guide a larger study evaluating the efficacy~     of gonadotropin releasing hormone agonist (GnRHa) as ovarian preservation therapy in young~     subjects receiving chemoradiation.~   "
67967|NCT02677298|"~     The aim of this study is to assess the efficacy and safety of BoNT/A-DP in the treatment of~     glabellar lines in comparison with placebo, including efficacy after repeat treatments and~     long term safety.~   "
67968|NCT02677285|"~     This study consists of two clinical series. With the first series investigators monitor the~     healing of skin grafts with bioimpedance measurements. The bioimpedance measurement is done~     with a purpose built patch that has electrodes in contact with the wound and reference~     electrodes.~      In the second series the investigators monitor closed operational wounds (breast~     reconstruction surgery patients) with bioimpedance measurements. This series is also~     conducted with bioimpedance measurements but the wounds are operational wounds.~      Both groups will have 20 patients.~   "
67969|NCT02677272|"~     According to the data of our nursing homes (NH) research network (REHPA - Gérontopôle~     Toulouse, 345 nursing home in France), 13.5% of NH residents are hospitalized every 3 months~     or about 50% per year. These hospitalizations concern for half, transfers to emergency~     department (ED). Data from the literature and the PLEIAD study, conducted with 300 NH in~     France, confirm that intense flows between NH and ED. These studies also support the idea~     that these transfers to ED potentially expose some NH residents to iatrogenic complications,~     a risk of functional decline, an increased risk of mortality, and generate additional health~     costs. To transfer to ED residents who will benefit from emergency care and not to transfer~     to ED residents for whom this transfer generates a higher risk than the expected benefit is~     the goal to reach to guarantee the better quality of care for NH residents.~      Inappropriate transfer to ED may be defined by the absence of somatic emergency and / or~     palliative care known before transferring to ED and / or the presence of advance directives~     of non-hospitalization in the resident's file. This is a clinical situation that could be~     managed by other means that the transfer to ED without loss of opportunity for the patient.~      The primary objective of our study is to determine the factors predisposing NH residents to~     inappropriate transfer to ED.~      Our hypothesis is that inappropriate transfers to the ED of NH residents are conditioned by~     factors accessible to interventions such as the organization of the NH care system or by~     improving the management of some diseases in NH. Investigators also hypothesize that the cost~     of inappropriate transfers to the ED is considerable. Acknowledgement of costs generated by~     inappropriate transfers to ED would allow policy makers to make strategic decisions to~     improve care system.~   "
67970|NCT02677259|"~     Optimizing in vitro fertilization (IVF) success is more important than ever, in light of new~     public funding of IVF in Ontario, Canada. In patients undergoing IVF using~     gonadotropin-releasing hormone (GnRH) analogues, the luteal phase appears to be compromised,~     which may be a result of controlled-ovarian hyperstimulation, significant fluctuations in~     hormone levels, the impact of the oocyte retrieval process, or direct compromise of the~     corpus luteum. Progesterone support is definitely necessary during the luteal phase to~     facilitate implantation but whether estrogen supplementation is also needed remains unclear.~     The present study aims to determine whether estradiol support during the luteal phase~     improves clinical pregnancy rate in patients undergoing IVF.~   "
67971|NCT02677246|"~     Children treated by bone marrow transplantation (BMT) experience bone toxicity. Those bone~     damages are caused by both a decrease of bone formation and an increase of bone destruction~     after BMT.For long term survivors, bone complications are major determinants of impaired~     quality of life. No standard treatment currently exists to prevent those bone injuries.~     Denosumab is a treatment which specifically blocks bone destruction for 4 to 6 months in~     adults. This trial will study whether it is safe to prescribe Denosumab to children after BMT~     in the aim of preventing bone complications.~   "
67972|NCT02677233|"~     To find out if lower levels of vitamin D is more prevalent in preeclamptic women~   "
71217|NCT02634788|"~     The primary objective of this trial is to evaluate analgesic efficacy of Buprenorphine~     Sublingual (under the tongue) Spray compared with placebo in participants with postoperative~     pain after bunionectomy.~   "
67978|NCT02677155|"~     Follicular lymphoma (FL) is the most common subtype of indolent non-Hodgkin's lymphoma and is~     often diagnosed in advanced incurable stage. In our previous trail, Lymvac-1, patients were~     treated with sequential intratumoral injections of low-dose rituximab and autologous~     dendritic cells, combined with local radiotherapy at the same site. The aim was to overcome~     tumor tolerance. In this trial, clinical responses correlated strongly with systemic~     anti-tumor CD8+ T-cell responses detected in blood after therapy. The primary aim of the~     planned study (Lymvac-2) is to significantly improve rates of immunological and clinical~     responses by adding iv anti-PD-1 antibody (Pembrolizumab) relative to the cohort of patients~     previously treated with intranodal immunotherapy without Pembrolizumab (Lymvac-1). The study~     includes 20 patients with untreated or relapsed FL.~   "
67979|NCT02677142|"~     Tumours affecting the brain are a very heterogeneous group of diseases. Accordingly,~     treatment strategies vary widely depending on child's age, tumour location, its resectability~     and histology. As a group, however, the survival rate of childhood brain tumors has improved~     in recent years, resulting in an increased number of survivors returning to school and~     reintegrating into their communities. Survival for many of them, however, has also come with~     severe costs such as neurocognitive and academic difficulties. Cognitive rehabilitation~     strategies to address these deficits have been a major focus of recent research. Evidence is~     now also mounting for social competence deficits among this population which may persist into~     late adolescence and adulthood, thereby negatively affecting long-term survivorship. Thus,~     there is an urgency to identify psychosocial interventions, such as social skills programs,~     that can reduce the social competence deficits in childhood brain tumor survivors and,~     therefore, modify the course of these outcomes to ensure that survivors thrive and become~     productive members of society. To date, no rigorous social skills intervention trials have~     been undertaken to address the social difficulties of these survivors. The current proposal~     is the first study that aims to address this gap by evaluating the efficacy of an innovative,~     manualized, social skills intervention program developed for this population using a~     multi-centre Randomized Control Trial (RCT).~   "
67980|NCT02677129|"~     The study is a randomized controlled trial with the aim to examine the feasibility and the~     effects of a home-based exercise intervention program on activities of daily living (ADL) in~     patients with advanced gastrointestinal cancer undergoing chemotherapeutic treatment. Further~     outcomes include functional and body status, quality of life, body composition, and~     chemotherapy completion rate. Study participants will be randomized to an exercise~     intervention group or a wait-list control group~   "
67981|NCT02677116|"~     The main purpose of this study is to evaluate the safety of different doses of olaratumab and~     to determine which dose should be used for future pediatric studies. The present study is~     open to children with advanced cancer or cancer that has spread to another part of the body.~     The study has three parts. In the first two parts, a specific dose of olaratumab will be~     given in 21 day cycles, followed by one of three standard chemotherapy regimens. In the third~     part, a specific dose of olaratumab will be given with one of three standard chemotherapy~     regimens in 21 day cycles. Participants will only enroll in one part.~   "
67982|NCT02677103|"~     Calcific tendinitis of the shoulder is a common enthesopathy, and is characterized by~     inflammation around calcium hydroxyapatite crystal deposits, usually located in the~     supraspinatus tendon, near its insertion place.1 The disease mainly affects individuals~     between 30 and 50 years of age, is painful in 50% of patients and frequently leads to~     considerable restriction of motion.2,3 It goes through three distinct stages: a precalcific~     stage (metaplasia of matrix), calcific stage (calcification of matrix and resorption of~     calific deposits), and a postcalcific stage (reconstitution of matrix).~      Classifications of calcific tendinitis have been proposed previously. Gartner proposed a~     classification based on plain films of the shoulder: type I deposits were sharply outlined~     and densely structured. Type III deposits had a cloudy outline and were transparent in~     structure. Type II deposits were features of both.4 Type III plaques have a tendency to~     resorb. Due to the progress of musculoskeletal ultrasound over the past decade,~     classification of the calcific tendinitis based on ultrasound findings was also proposed:~     arc-shaped (an echogenic arc with clear shadowing), fragmented or punctate (at least 2~     separated echogenic spots or plaques with or without shadowing), nodular (an echogenic nodule~     without shadowing), and cystic (a bold echogenic wall with an anechoic area).5 Plaques that~     appear fragmented, nodular, or cystic on ultrasound are considered in the resorptive phase.~      The treatment of patients with calcific tendinitis is typically conservative. The reported~     success rates vary between 30 and 85%.6 If the pain becomes chronic or intermittent after~     several months of conservative treatment, arthroscopic and open procedures are available to~     curette the calcium deposit, and additional subacromial decompression can be performed if~     necessary.7,8 As an alternative, minimally invasive extracorporeal shock wave therapy (ESWT)~     has been postulated to be an effective treatment option for treating calcific tendinopathy of~     the shoulder, before surgery.9-12 In recent years, radial shock wave has been developed. A~     radial shock wave is a low- to medium-energy shock wave that is pneumatically generated~     through acceleration of a projectile inside the handpiece of the treatment device and then~     transmitted radially from the tip of the applicator to the target zone. Radial shock wave~     showed a low pressure and a considerably longer rise time than extracorporeal shock wave. In~     radial shock wave therapy (RSWT), the focal point is not concentrated on the target zone, as~     occurred in ESWT, but on the tip of applicator. 13 Another new method of conservative~     treatment of calcific tendinopathy is ultrasound-guided fine-needle repeated puncture of the~     calcific plaque, as shown in previous study.14,15 The new method has the advantage of being~     easily operative, cheap, safe, and has a proven high success rate. Although percutaneous~     needle aspiration with a large size needle(≥ 18# needle) alleviates symptoms in up to 60% of~     patients and resolves the deposits in 40% to 74%,16,17 the larger size needle could result in~     tendon injury.~      In clinical practice, combination of radial shock wave therapy and ultrasound-guided fine~     needle repeated puncture is frequently used and shows promising results, however, scientific~     report has been rarely published before.18 The purpose of this study is to compare the~     efficacy of RSWT, ultrasound-guided fine needle puncture (USNP), and combination of RSWT and~     USNP in the treatment of calcific tendinitis of shoulder.~   "
67983|NCT02677090|"~     Determination of the digestive tolerability of the PROMITOR® in children from 3 to 7 years~     old.~   "
67984|NCT02677077|"~     The primary objective of the study is to retrospectively investigate the proportion of~     participants free of new or enlarging fluid-attenuated inversion recovery (FLAIR) lesions~     over time in approximately 300 Relapsing-Remitting Multiple Sclerosis (RRMS) participants~     with regular MRI follow-up, who have received natalizumab ≥24 month from two different~     observational cohorts: 1) approximately 230 participants from the Czech Republic; and 2)~     approximately 70 participants from Belgium. The secondary objectives of this study are as~     follows: Brain volume change by various measures; Changes in the number and volume of~     magnetic resonance imaging (MRI) lesions; No evidence of disease activity (NEDA) with and~     without brain volume change.~   "
67985|NCT02677064|"~     The investigators are doing this research study to assess the percentage of patients~     receiving stem cell transplantation for the type of blood cancer you have. They want to know~     how many patients get a transplant and why some patients do get a transplant while others do~     not. Also they want to explore why some patients elect not to undergo stem cell~     transplantation, when it is recommended by their physicians.~   "
67986|NCT02677051|"~     This study is a double blind treatment trial that will test if sulforaphane improves core~     symptoms in autism. The investigators expect to see clinical improvement in some of these~     areas. Sulforaphanes come from eating certain vegetables such as broccoli. The investigators~     will be using a preparation that gives specific and reproducible amounts. The investigators~     will also test specific chemicals and genes needed for sulforaphane usage to try to~     understand differences in response.~   "
67987|NCT02677038|"~     The goal of this clinical research study is to learn if olaparib can help to control~     metastatic pancreatic cancer. The safety of this drug will also be studied.~      This is an investigational study. Olaparib is FDA approved and commercially available for the~     treatment of ovarian cancer. Its use in this study is investigational. The study doctor can~     explain how the study drug is designed to work.~      Up to 24 participants will be enrolled in this study. All will take part at MD Anderson.~   "
67988|NCT02677025|"~     This supplement study is an adaptation of the larger NIH-funded parent study, the Women's~     Health CoOp+, which tests a combination biobehavioral HIV prevention approach to enhance~     standard HIV testing practices for alcohol and drug (AOD)-using women across the city of~     Pretoria, South Africa. The current supplemental study seeks to reach AOD-using female~     adolescents who experience the greatest burden of new HIV infections and are currently~     underserved by HIV and drug-treatment programs in Cape Town, South Africa and test the~     validation of both the instrument and adapted intervention.~   "
67989|NCT02677012|"~     During reconstructive surgery that involves autologous fat grafting (AFG -- transplanting~     fatty tissue from one part of your body to another), fat tissue is removed from one part of~     the body (usually the abdomen or legs) and inserted into another part of the body.~      This fat must be cleaned and filtered (processed) before being inserted back into the body.~      The goal of this clinical research study is to compare 3 techniques for processing fatty~     tissue that is collected during reconstructive surgery. Researchers want to compare the~     amount of fat processed and the length of time needed to complete AFG technique and surgery.~   "
67990|NCT02676999|"~     This project is set to describe by objective measures as the range of motion and~     weight-bearing ability of the distal radioulnar joint one to five years after primary~     implantation of a Scheker total distal radioulnar joint prosthesis.The range of motion and~     stability of the distal radioulnar joint (DRUJ) are important outcomes to preserve function,~     especially the pronation and supination. Unlike other ulnar endoprostheses that replace only~     the ulnar head, the Scheker prosthesis replaces the ulnar head, resurfaces the lesser sigmoid~     notch, and is semi-constrained in design.~   "
67991|NCT02676986|"~     This study is being carried out to see if the antiandrogen enzalutamide has antitumour~     effects in early breast cancer.~      Enzalutamide blocks the action of androgens on the androgen receptor (AR) and may slow down~     or stop breast cancers growing. Enzalutamide is approved for the treatment of prostate~     cancer.~      The trial will be offered to patients who have just been diagnosed with early breast cancer~     and who are planned to have surgery in the next few weeks. The treatment will bridge the time~     between the diagnosis and surgery and will be given for 2- 4 weeks. To assess the effect of~     the treatment, small samples of breast cancer tissue will be analysed before the start and~     after treatment. The pre-treatment assessment will be done on archived tissue but patients~     might require an additional biopsy, if sufficient stored tumour tissue is not available. The~     end of treatment samples will be taken during surgery, unless the patient will receive~     medical treatment first instead of surgery which might mean additional biopsies of the breast~     cancer have to be taken. The trial has two cohorts. The cohort of patients with oestrogen~     receptor (ER) positive breast cancer will test if adding enzalutamide to exemestane is better~     at slowing the growth of breast cancer than exemestane alone. This cohort will recruit 141~     evaluable post-menopausal patients with a tumour size of at least 1 cm. The aromatase~     inhibitor exemestane is approved for the treatment of ER positive breast cancer. Blocking~     aromatase decreases oestrogens but can increase androgens. Enzalutamide is therefore added to~     block the action of androgens on the AR.~      In the second cohort of patients with triple negative breast cancer (TNBC), enzalutamide will~     be given alone to see if it can slow the growth tumours with androgen receptors. As only~     approximately 30% of TNBCs express the AR, a pre screening step will be included to test the~     tumour AR expression, before patients are approached for the ARB trial. The TNBC cohort will~     comprise 55 patients.~   "
67992|NCT02676973|"~     The study is a multi-center, randomized, surgical trial of women with symptomatic~     post-hysterectomy apical (cuff) prolapse desiring surgical treatment. This study will compare~     the three available surgical treatments performed in usual practice. The purpose of this~     study is to compare two commonly performed mesh apical repair (sacral colpopexy vs. Apical~     Transvaginal Mesh) and vaginal native tissue apical repairs with mesh reinforced repairs. The~     primary outcome is measured over time (up to 60 months) using a survival analysis approach.~      The investigators hypothesize that treatment failure will not differ between vaginally and~     abdominally placed mesh for vault vaginal prolapse, and mesh repairs (regardless of route of~     implantation) will be superior to native tissue apical suspension.~   "
67993|NCT02676960|"~     The purpose of this study is to perform brain scans using magnetic resonance imaging (MRI)~     instrument on children aged 6 months, 1 year, and 2 years. This procedure is usually done~     with sedation but the study will see if it can be done without sedation.~   "
67994|NCT02676947|"~     An open label study to assess the safety and efficacy of tocilizumab in group 1 pulmonary~     arterial hypertension patients~   "
67995|NCT02676934|"~     the study compares the use of end tidal (Et) control of sevoflurane during anesthesia for~     living donor hepatectomy versus fresh gas (FGF) control. Et control is hypothesized to be as~     effective as FGF control with less cost and more operator satisfaction.~   "
67996|NCT02676921|"~     The objectives of this study are :~        1. to test the the osteogenic potential of human maxillary sinus schneiderian membrane~          (hMSSM).~        2. To investigate the expression of mesenchymal stem cell marker (STRO-1), a marker of~          mesenchymal progenitor cells using flow cytometry, and Alkaline phosphate expression,~          Red alizarin and Von Kossa staining and quantitive PCR.~   "
67997|NCT02676908|"~     Compression stockings are traditionally worn for a period of time after varicose vein surgery~     to reduce pain and bruising. The investigators provide an ambulatory endovenous ablation~     service. Patients come to the Veins Unit, receive oral sedation, have their veins treated~     with either laser or radiofrequency ablation plus phlebectomies* under local anaesthetic,~     recover for an hour and then go home. *Phlebectomy describes the technique of pulling out~     small varicose veins through small incisions in the overlying skin. The standard practice of~     the Veins Unit is to advise patients to wear class two compression stockings for four weeks~     post-operatively. Many patients would prefer a shorter period of time in stockings.~      The Nice Guidelines for Varicose Veins has posed the question: 'How long should stockings be~     worn for after endovenous ablation?'~      Three trials have addressed this issue:~      Bakker looked at patients who wore stockings for either two or seven days after laser~     ablation only; the group who wore stockings for seven days fared better.~      Elderman looked at patients who either wore no stockings or stockings for two weeks after~     laser ablation only; the group who wore stockings for two weeks had less pain.~      Krasznai looked at patients who wore stockings for either 4 hours or 72 hours after~     radiofrequency ablation only; there was no significant difference in post-op pain among~     groups.~      None of these trials included patients who had phlebectomies at the same time. This study~     aims to answer the question 'How long is it necessary to wear compression stockings for after~     endovenous ablation (either laser or radiofrequency) plus concomitant phlebectomies?' The~     investigators plan to divide 110 patients into two groups- either 'stockings for 2 weeks'~     (trial group) or 'stockings for 4 weeks' (usual treatment group).~      Pre-operatively, all patients will fill out a pain score and two short quality of life~     questionnaires, one specific to varicose veins. Post-operatively at home, all patients will~     be asked to keep a diary of pain and analgesia use. They will also document bruising at seven~     days on charts and on a visual scale. At their four week clinic review, all patients will be~     asked to fill out a pain and bruising score, a bruising chart and the two short quality of~     life questionnaires again.~      The group with the best pain, bruising and quality of life scores post-operatively will help~     guide duration of compression therapy for future patients.~   "
67998|NCT02676895|"~     The purpose of this study is to evaluate the safety and the immunogenicity of two different~     doses of the GVGH S. sonnei vaccine in healthy adults and represents the first step towards~     testing of the GMMA vaccine in the vaccine target population of children from developing~     countries where shigellosis is endemic.~   "
67999|NCT02676882|"~     The purpose of this study is to assess the effectiveness of the EnBrace HR prenatal~     supplement in preventing depression in women with a history of depression who have decided to~     stop taking antidepressants during their pregnancy, or treating women who are currently in a~     depressive episode while pregnant or planning pregnancy.~   "
68000|NCT02676869|"~     The purpose of this study is to determine the safety, tolerability and recommended phase 2~     dose of a new drug, known as IMP321, in combination with pembrolizumab when given to patients~     with unresectable or metastatic melanoma.~   "
68001|NCT02676856|"~     The purpose of this study is to evaluate the efficacy of hematopoietic stem cell~     microtransplantation for in acute myeloid leukemia (AML)patients who can not receive~     hematopoietic stem cell transplantation (HSCT).~   "
68002|NCT02676843|"~     The study will investigate the ability of a new PET tracer, 18F-AV-1451, to detect~     depositions of a protein, called tau, in the brains of people with a mutation in the tau gene~     that causes deposition of the protein, and in people without the mutation. A single~     18F-AV-1451 scan will be performed on control subjects without MAPT mutations, presymptomatic~     mutation carriers, and symptomatic mutation carriers.~   "
68003|NCT02676830|"~     The purpose of this study is to Evaluation of absorption, metabolism, and excretion of~     [14C]-K-312 and estimation of the absolute bioavailability of K-312 in healthy male subjects~   "
80431|NCT02514135|"~     The aim of the proposed study is to determine the incidence and prevalence of intra-abdominal~     hypertension and abdominal compartment syndrome in consecutive intensive care admissions~     using broad inclusion criteria.~   "
68004|NCT02676817|"~     The aim of the study is to construct and validate an endomicroscopic score correlated with~     microscopic inflammation activity in patients with UC.~      Probe-based confocal laser endomicroscopy (pCLE) is a new endoscopic imaging modality, which~     offers the possibility to perform in vivo mucosal microscopic analysis in real time during~     endoscopy.~      Primary Objectives : Development and validation of a UC endomicroscopic score, after~     correlation between pCLE data and histological data using the Geboes' score as a gold~     standard during ulcerative colitis.~      Secondary Objectives:~        -  Identify predictive factors for the response to adalimumab.~        -  Identify predictive factors for recurrence in patients with UC in remission (Mayo score~          0 or 1).~        -  Safety of the pCLE procedure~   "
68005|NCT02676804|"~     This is a prospective, pre-post intervention study to evaluate the effect of a~     high-intensity, aerobic exercise program on outcomes of cognition, mood, gait, balance,~     cardiorespiratory fitness, neuromuscular performance, fatigue, sleep, and quality of life for~     patients diagnosed with idiopathic Parkinson disease. The primary outcomes will be a~     composite measure of cognitive function and the Timed Up and Go (TUG).~   "
68006|NCT02676791|"~     The LOCARE-Trial is an investigator initiated, randomized-controlled trial with two parallel~     arms (n=60 each) and investigates the influence of esophageal washout on long-term outcomes~     in patients undergoing elective esophageal resection for carcinoma. The primary endpoint is~     defined as local carcinoma recurrence. Secondary endpoints will be locoregional and distant~     recurrence, disease-specific survival and esophageal cancer specific survival.~   "
68007|NCT02676778|"~     The purpose of this study is to evaluate the objective response rate (ORR) of E7777 in~     participants with relapsed or refractory peripheral T-cell lymphoma (PTCL) and cutaneous~     T-cell lymphoma (CTCL).~   "
68008|NCT02676765|"~     The purpose of this study is to determine if sublingual allergen immunotherapy tablets work~     by inducing a state of desensitization in mast cells and basophils.~   "
68009|NCT02676752|"~     This research trial studies skin/soft tissue elasticity in head and neck cancer survivors~     with lymphedema and fibrosis. Lymphedema and fibrosis is a common effect of head and neck~     cancer which may lead to skin tightness, pain, and body image issues. Early detection of~     lymphedema and fibrosis may help reduce serious functional loss of the neck. Shear wave~     elastography is a technique that provides a quantitative measure of stiffness using a push~     pulse to generate shear waves within the tissues. Conventional imaging techniques are then~     used to monitor the shear waves generated through the tissue to calculate the shear wave~     speed. Shear wave elastography may help obtain an early and accurate measurement of tissue~     elasticity in head and neck cancer survivors.~   "
68010|NCT02676739|"~     This 12 week randomized placebo-controlled study will compare the effects of 10 mg and 20 mg~     of a mixed amphetamine salt, extended release medication (trade name Adderall XR) to placebo~     on objective measures of processing speed and memory, as well as on self-reported measures of~     cognition and quality of life. To be enrolled in the study, MS subjects must demonstrate~     impaired processing speed on the Symbol Digit Modalities Test (SDMT).~   "
68011|NCT02676726|"~     The purpose of this study is to determine whether or not there are more complications in the~     extraperitoneal compared with the transperitoneal approach for laparoscopic aortic~     lymphadenectomy for the surgical staging of endometrial or ovarian cancer~   "
68012|NCT02676713|"~     Endometriosis is a common, chronic disease. 30% to 50% of women with endometriosis are~     infertile. There is moderate quality evidence that laparoscopic surgery to treat mild and~     moderate endometriosis increases live birth or ongoing pregnancy rates. There was no evidence~     of benefit for post-surgical hormonal suppression of endometriosis compared to surgery alone~     for the outcomes of pregnancy rates. Past studies have confirmed that Chinese herbal medicine~     can inhibit post-surgical endometriosis recurrence, increase pregnancy rate.This study~     evaluates the efficacy and safety of Traditional Chinese Medicine Sequential Treatment of~     endometriosis-associated infertility. The study objective is to confirm that clinical~     pregnancy rate of patients with endometriosis-associated infertility post-conservative~     surgery accepting Chinese medicine activating blood, dredging liver and nourishing kidney~     sequential treatment is higher than expectant treatment.~   "
68013|NCT02676700|"~     This study examines the effect of adding so called Kaatsu training to pelvic floor muscle~     training. Half the participants will perform Kaatsu training on their thigh muscles followed~     by pelvic floor muscle training. The other half will receive pelvic floor muscle training~     alone.~   "
68014|NCT02676687|"~     Gliomas, especially high grade gliomas and diffuse low grade gliomas, are characterized by~     their infiltrative nature. Recently, a new conception of supratotal resection has been~     proposed. Given the lack of prospective supporting data, the correlation between supratotal~     resection and the survival of patients with glioma need to be established.~      Therefore, the investigators aim to do a single center prospective randomized controlled~     clinical trial to assess the effect of supratotal resection at least 1 cm beyond the MR~     imaging-defined abnormalities on progression-free survival (PFS) of glioma.~   "
68015|NCT02676674|"~     This is a pre-post open label trial to assess the change in Vitamin D blood levels following~     treatment with three doses of topical Vitamin D3 in 20 subjects with existing Vitamin D~     deficiency.~   "
68016|NCT02676661|"~     To investigate the prevalence and risk factors for peri-implant disease in partially~     edentulous patients rehabilitated with implants supported crown or bridge so as to provide~     evidence for clinical prevention and control.~   "
68017|NCT02676648|"~     The goal of the research is to optimize an online and mobile multicomponent 12-month diet and~     lifestyle intervention for improving the blood glucose control of individuals with type 2~     diabetes.~   "
68030|NCT02676479|"~     The study will involve up to 30 pairs of male and female sexually intimate partners who are~     carriers for a genetic disease (e.g Sickle Cell Disease or Thalassemia) and at high risk of~     transmitting the gene. The female partner will be superovulated to mature multiple oocytes~     which can be fertilized, inseminated with her partner's sperm through intra-uterine~     insemination (IUI). Four to six days after IUI, the female partner will undergo a~     non-surgical uterine lavage procedure to recover preimplantation embryos.~   "
68031|NCT02676466|"~     ENRGISE Pilot Study will test the ability of anti-inflammatory interventions for preventing~     major mobility disability by improving or preserving walking ability.~   "
68018|NCT02676635|"~     Masons have the highest rate of overexertion injuries among all construction trades and rank~     second as an occupation for back injuries in the United States. Identified ergonomic~     solutions are the primary method of reducing exposure to risk factors associated with~     musculoskeletal disorders. However, many construction workers lack knowledge about these~     solutions, as well as basic ergonomic principles. Construction apprentices, as they embark on~     their careers, are greatly in need of ergonomics training to minimize the cumulative exposure~     that leads to musculoskeletal disorders. Apprentices receive safety training; however,~     ergonomics training is often limited or non-existent. In addition, apprenticeship programs~     often lack soft skills training on how to appropriately respond to work environments and~     practices that are unsafe. The SAVE program - SAfety Voice for Ergonomics - strives to~     integrate evidence-based health and safety training strategies into the mason apprenticeship~     skills training to teach ergonomics, problem solving, and speaking up to communicate~     solutions that reduce musculoskeletal injury risk. The central hypothesis is that the~     combination of ergonomics training and safety voice promotion will be more effective than no~     training or either ergonomics training alone or safety voice training alone.~      Following the development and pilot testing of the SAVE intervention, SAVE will be evaluated~     in a cluster-randomized controlled trial at 12-15 masonry training centers across the U.S.~     Clusters of apprentices within centers will be assigned at random to one of three~     intervention groups (n = 32 per group): (1) ergonomics training only, (2) combined ergonomics~     and safety voice training, or (3) control group with no additional training intervention.~     Outcomes assessed at baseline, at the conclusion of training, and then at six and 12 months~     post training will include: musculoskeletal symptoms, general health perceptions, knowledge~     of ergonomic and safety voice principles, and perception and attitudes about ergonomic and~     safety voice issues.~   "
68019|NCT02676622|"~     Crohn's disease is an 'auto-immune' disorder of the gut. In this condition the body's own~     immune system is fighting its gut and causing inflammation and other symptoms. Patients who~     are refractory (not responding) to the medications usually used to control Crohn's disease~     (medicines like steroids, azathioprine, methotrexate, cyclophosphamide and antibodies like~     Infliximab), may consider being part of this study.~      In this study, the investigators plan to wipe out (ablate) the 'faulty immune system' with~     medicines (immune-ablation) and then give back the patients own stored stem cells (that have~     been collected before) - a procedure called autologous (self) stem cell transplant (ASCT).~     Once the new immune system regrows again from the stem cells, it is hoped that the 'faulty'~     immune cells do not return again and do not fight the gut leading to remission from symptoms~     of Crohn's disease. The aim of this treatment therefore, is to reset or re-program the immune~     system, so that it does not fight the patient's own body.~      Currently, there are very few trials and experience with this procedure in children and young~     adults. There have been a few studies that have shown benefit of ASCT procedure in adult~     patients. In some patients, the benefit lasted for 1-5 years; but 1 in 5 (20%) participants~     were not taking their medications for the Crohn's disease even 5 years after ASCT. Other 80%~     needed medications again, but in most cases with better disease control.~      In order to potentially improve the long term outcomes of ASCT, the investigators are adding~     another medication (in addition to those used in adult studies) called IL-2 (Aldesleukin),~     which will be given as an every-other-day injection under the skin (subcutaneous) at very low~     doses for 6 weeks after the ASCT and can be taken at home. Low dose IL-2 is known to increase~     a type of immune cell called T-regulatory cells (Tregs) that make immune cells less reactive~     to self. Study doctors believe that increased population of Tregs after ASCT may lead to a~     better control of Crohn's disease- higher percentage of cures or disease control for a longer~     period of time compared to the previous adult trials.~      Therefore, the goals of this study are-~        1. To see if ASCT can be used safely and can provide substantial benefit in young adults~          who have refractory Crohn's disease.~        2. To see if addition of IL-2 after the ASCT is safe and effective.~   "
68020|NCT02676609|"~     During this study, we will assess a new smart phone application which aims at helping~     patients with Type 1 diabetes to compute food carbohydrates and meal insulin doses. Patients,~     already trained to carbohydrate counting, will be recruited among those who have been using~     this method daily for at least 6 months. They will complete two one-month study phases, using~     the application in one phase and counting carbohydrate and insulin doses without the~     application in the other phase, with randomized order of each phase. Visits are scheduled at~     the start and at the end of each phase to collect data on glucose control and insulin doses.~     Questionnaires assessing health-related quality of life and ability of self-management of~     diabetes will also be filled by patients before and after each study phase.~   "
68021|NCT02676596|"~     The purpose of this study is to investigate the safety tolerability, and PK profile of K-312~     and its metabolites in healthy Japanese and non-Japanese adults.~   "
68022|NCT02676583|"~     Objective: Postoperative pain is the main complaint in children undergoing tonsillectomy. An~     inexpensive method and with few evidence in the literature on effectiveness in reducing pain~     is the closure of the tonsillar fossa by suture with absorbable sutures. The investigators~     will compare the pain after tonsillectomy between closure or not the tonsil fossa.~      Study design: Prospective, randomized, double blind, and controlled. Method: Two hundred~     otolaryngologic outpatients with indication of bilateral tonsillectomy for repeated~     tonsillitis, tonsillar hypertrophy or sleep apnea between 5 and 12 years old will be enrolled~     from November 2015 to July 2016. The procedure will be performed by a single surgeon and~     similar postoperative medications will be prescribed. There will be two techniques: closure~     or not of the tonsillar fossa with catgut points. A questionnaire containing a Faces Pain~     Scale - filled 1 and 7 days after surgery- and other data - difficulty of detachment of the~     palatine tonsils, hemostasis technique, surgical complications, healing characteristics, day~     of total improvement of the pain, day of beginning of normal food intake, presence of~     postoperative bleeding, complications and observations raised by the patient - will be~     applied.~   "
68023|NCT02676570|"~     1. Isolate fungal DNA(Deoxyribonucleic acid) from paraffin-fixed tissue specimens to~          distinguish and compare Aspergillus species to the existing optical pathological~          diagnosis.~        2. PCR(polymerase chain reaction) validation.~        3. Compare PCR results, microbial results and treatment results with the medical record.~   "
68024|NCT02676557|"~     The burden of LASIK surgery on optic nerve head (ONH) has been controversial. Until now, the~     change of retinal nerve fiber layer (RNFL) thickness was used as the indicator of the study.~     In the present study, the investigators intended to investigate whether the changes of the~     deep and superficial structures around ONH exist or not using EDI OCT.~   "
68025|NCT02676544|"~     This is a prospective, open label single center feasibility study to demonstrate basic safety~     and effectiveness of prostate artery embolization for the treatment of symptomatic benign~     prostatic Hyperplasia (BPH) in a small series of patients with large (≥90 grams) glands.~   "
68026|NCT02676531|"~     This study is to evaluate the effects of Walking Meditation on vascular function in breast~     cancer patients receiving Anthracyclines chemotherapy~   "
68027|NCT02676518|"~     Association between serum anti-Mullerian hormone (AMH) level and prevalence of glucose~     intolerance and metabolic syndrome in women with polycystic ovary syndrome (PCOS)~   "
68028|NCT02676505|"~     The primary purpose of this study is to compare the effects of two different methods of care~     during the second stage of labor for nulliparous women (coached versus uncoached pushing) on~     the length of the second stage and how this may affect maternal and neonatal outcome.~   "
68029|NCT02676492|"~     This study will explore the relationship between sleep, learning, cognition, mood and~     behaviour in children with Tic Disorders (Tourette Syndrome and Chronic Tic Disorder)~     compared to typically developing peers.~   "
68032|NCT02676453|"~     Objective: The aim of this study was to evaluate the effects of dental hygienist support on~     oral health and attitudes to oral healthcare in nursing homes for older people.~      Background: Studies in long-term care facilities have indicated that oral health is often~     unsatisfactory. It is important that nursing staff are able to assist dependent care~     recipients. Dental hygienist support has been suggested as valuable help.~      Material and methods: Two nursing homes were randomly selected for intervention and control.~     Interventions included weekly support from dental hygienists on oral hygiene procedures,~     prescriptions for individual oral hygiene procedures, and oral care organisational issues.~     The residents' oral health, measured by dental plaque levels, gingival bleeding and the~     Revised Oral Assessment Guide (ROAG), was evaluated before and after three months. Attitudes~     among the staff to oral healthcare were collected through a questionnaire.~   "
68033|NCT02676440|"~     This study is a double-blind, randomised, parallel group efficacy study. Up to 240 healthy~     female and male participants aged over 18 years will participate. There will be two groups of~     up to 120 participants. Participants will be randomised to the test groups according the~     allocation table prepared by the Statistician.~      Participants will be enrolled on to the study according to the inclusion/exclusion criteria.~     After enrollment participants will have their teeth that have been allocated for assessment~     cleaned using a professional prophylaxis polish by the study dentist. The participants will~     then be provided with a standard cosmetic silica Fluoride toothpaste and a toothbrush to use~     at home, twice a day for up to four weeks. After this time they will return to the test site~     and have the baseline dental assessments. Participants will then be randomly allocated to one~     of the two test products which they will use at home, twice a day for the duration of the~     study. Dental assessments will be conducted after 13 and 26 weeks of product use at the study~     site.~   "
68034|NCT02676427|"~     The study aims at clarification of venous collapsibility measures with real venous flow~     measurements during dynamic maneuver testing fluid responsiveness in septic shock patients.~   "
68035|NCT02676414|"~     The primary purpose of this study is to assess the effect of participating in the interactive~     hypertension education program of the German Hypertension League (DHL©) My blood pressure -~     OK! on office systolic blood pressure.~   "
68036|NCT02676401|"~     This study aims to evaluate the safety and efficacy of MT-3995 administered over the longer~     term, following MT-3995-J05 study.~   "
68037|NCT02676388|"~     The purpose of this study is to compare the effect of freeze-dried, capsulized FMT and fresh~     FMT in adults with slow transit constipation.~   "
68038|NCT02676375|"~     The study investigators will enroll 45 treatment seeking, cigarette smokers with a Diagnostic~     and Statistical Manual (DSM-IV) diagnosis of schizophrenia who will be randomly assigned into~     three arms of treatment for smoking cessation treatment, receiving either 1. Control:~     standard therapy (n=15), including stepwise monotherapy of nicotine patch or bupropion~     sustained release, 2. Extended treatment with combination bupropion, nicotine patch, and~     nicotine lozenge for 6 months (n=15), or 3. Extended treatment with combination bupropion,~     nicotine patch, and nicotine lozenge for 6 months with home visits (n=15) and phone calls to~     the home or living facility. During all treatments, participants will receive weekly smoking~     cessation group counseling, as is standard for smoking cessation treatment. At the time of~     enrollment, participants will complete a one-study visit lead-in to complete baseline~     assessments, psychological and medical evaluation, and comprehensive assessment of drug use~     to determine study eligibility. Once determined to be eligible for the trial, participants~     will be randomly assigned to one of the treatment arms using a randomization procedure. The~     standard therapy treatment arm, or control group, will receive either nicotine patch taper~     starting at 21 milligrams (mg) daily, nicotine lozenge as needed, and/or bupropion sustained~     release at 150mg daily for 3 days, then 150 mg twice a day for a total of 12 weeks. The~     extended therapy arm will start the nicotine patch at 21mg daily with as needed nicotine~     lozenge for breakthrough cravings and initiation of bupropion sustained release at 150mg~     daily for 3 days a week prior to starting nicotine replacement, then 150 mg twice daily for 6~     months (as tolerated). The third arm will be identical to the second arm except for the added~     home visit intervention.~   "
68039|NCT02676362|"~     The mechanisms underlying the formation and composition of gingival crevicular fluid (GCF)~     and its flow into and from periodontal pockets are not understood very well. The aim of this~     study was to evaluate the length of sampling time and sequential sampling of GCF neutrophil~     elastase (NE) enzyme activity by using intracrevicular and orifice methods.~   "
68040|NCT02676349|"~     This is a prospective, randomized phase II trial. The aim of this study is to assess the~     efficacy of two therapeutics strategies. Patients with borderline-resectable pancreatic~     cancer (BRPC) will be randomly in two arms : neoadjuvant mFolfirinox followed with or without~     preoperative chemoradiotherapy with capecitabine.~   "
68041|NCT02676336|"~     This is a randomized, double-blind, placebo controlled, multi-center study to evaluate the~     safety, tolerability and potential effects of dietary supplement Violet™ Iodine on breast~     health in women with cyclic breast discomfort and tenderness to eliminate the evaluation of~     effectiveness.~   "
68052|NCT02676193|"~     The investigators are addressing two critical areas identified by the FDA: the impact of~     cigarette packaging and labeling on consumer perceptions and on smoking behavior; and the~     effectiveness of graphic warning labels on communicating risk of tobacco products. In a~     randomized controlled trial (RCT), investigators will enroll committed smokers who have no~     intention of quitting in the next 6-months. The three study arms will be: a) a plain pack~     with all marketing materials removed (PP); b) The Australian graphic warning images~     (Australian model-AM); or c) a standard pack with all marketing materials unaltered (ST). The~     study includes a three month purchasing intervention and continued follow-up through 12~     months. Throughout the study interactive text messaging assessments will be used to measure~     acute and persistent impact of labeling and marketing on perceptions of tobacco products,~     subjective effects of consumption, awareness of tobacco-related harms, tobacco use behavior,~     and quitting motivation. At three separate time points, participants will: a) complete a~     web-based questionnaire b) provide a saliva sample for cotinine analysis. The rigorous design~     and extensive objective measurements are significant innovations on the currently published~     research in this field and should lead to significant advances in tobacco regulatory science.~   "
68042|NCT02676323|"~     Cancer is the uncontrolled growth of human cells. The growth of normal human cells is~     controlled by multiple mechanisms. Panobinostat belongs to a class of chemotherapy drugs~     called histone deacetylase (HDAC) inhibitors. HDAC inhibitors like panobinostat block~     enzymes known as histone deacetylases, which stops cancer cells from dividing and causes them~     to die. Fludarabine and cytarabine are chemotherapy drugs that are commonly used to treat~     pediatric patients with refractory or relapsed acute myeloid leukemia (AML) or~     myelodysplastic syndrome (MDS).~      The purpose of this study is to test the safety of panobinostat and to find the highest dose~     of panobinostat that can be given safely when it is combined with fludarabine and cytarabine.~      This pilot study will be done in two parts: The goal of Part 1 of the study is to find the~     highest tolerable dose of panobinostat that can be given to patients with AML or MDS, when it~     is combined with fludarabine and cytarabine. Once that dose is determined, participants will~     be enrolled on Part 2: Dose Expansion, to look at the effect of the~     panobinostat/fludarabine/cytarabine combination in patients with leukemia/MDS.~      PRIMARY OBJECTIVE:~        -  Determine a tolerable dose of panobinostat when given in combination with fludarabine~          and cytarabine in pediatric patients with relapsed or refractory AML or MDS.~      SECONDARY OBJECTIVES:~        -  Characterize the pharmacokinetics of panobinostat after the first dose and at~          steady-state.~        -  Estimate the overall response rate to the combination of panobinostat, fludarabine, and~          cytarabine.~   "
68043|NCT02676310|"~     This is a safety, tolerability, and pharmacokinetics study of bimatoprost in male patients~     with androgenetic alopecia (AGA).~   "
68044|NCT02676297|"~     The purpose of this study is to compare the absorption of two different inhalation products~     with the reference product in healthy volunteers.~   "
68045|NCT02676284|"~     This was a prospective, open, non-comparative study in 36 subjects with rhizarthrosis~     comparing signs and symptoms before and after a single injection of DUROLANE SJ in the~     affected hand. Subjects were assessed pre-treatment and at 1, 3, and 6 months post-treatment.~   "
68046|NCT02676271|"~     Background: Varus derotation osteotomy (VDRO) is one of the most popular surgical treatments~     for Legg-Calvé-Perthes disease yet its long term results have not been assessed. Our purpose~     was to determine the long term clinical and radiographic outcomes of these patients.~      Methods: Forty patients (43 hips) who had undergone VDRO for LCPD who participated in a long~     term follow-up study a decade ago were approached for the present study.~      All patients were treated in our institution during 1959 to 1983 with proximal VDRO.~      The patients were invited to for a medical interview and a physical examination. They were~     also asked to fill out questionnaires and to provide or undergo a standing anteroposterior~     (AP) pelvic and a lateral hip radiographs during the visit.~      Patients were asked to self-grade their hip pain as none, mild, moderate or severe and to~     grade their back pain using the Visual Analogue Scale (VAS) between 0-10. Details regarding~     daily function, physical activity, work status and family history were obtained. All~     participants completed the Harris Hip Score (HHS) with a maximum score of 100 and the Short~     Form-36 which is composed of 8 sections and has a maximum score of 100.~      The physical examination included an assessment of the hip range of motion, leg length~     discrepancy and the presence of a Trendelenburg sign.~      Radiographic parameters evaluated were the Tonnis grade (with a score between 0-3), head size~     ratio, and the center-edge (CE) angle.~   "
68047|NCT02676258|"~     The objective of this study is to evaluate a new daily disposable silicone hydrogel soft~     contact lens by comparing to an existing daily disposable soft contact lens.~   "
68048|NCT02676245|"~     To address the content, timing, efficacy, and impact of prenatal education about newborn~     screening generally and sample retention specifically.~   "
68049|NCT02676232|"~     Chronic and recurrent pain is a very important issue in the society, and its treatment is~     challenging.~      In children, one of the most common pain problems is recurrent abdominal pain. This problem~     can affect up to 12% of the children population, and can interfere on daily activities of~     both children and parents. Recurrent abdominal pain in children is also associated with other~     health problems, and can be related to problems in adulthood. Unfortunately, the current~     health system does not have an effective treatment for these children and their families.~     This is why the investigators propose an online intervention, DARWeb, for people in this~     situation.~      DARWeb provides an innovative solution using Information and Communication Technology to~     facilitate access. It is also innovative because it is directed towards secondary prevention,~     in contrast to the majority of current treatments available for pain problems that are~     focused in reducing the impact of pain when it is already severe. Thus, the objective of~     DARWeb is to provide information and teach strategies to children and their parents that help~     them to cope with pain and prevent pain interference in their daily lives (in the short,~     medium and long term).~      With this project, the investigators plan, first, to create a new version of their treatment~     program (DARWeb V2) from the results of the pilot study. Second, the investigators will test~     the effects of DARWeb V2 through a randomized clinical trial with a large sample, and they~     will assess the short, medium and long term effects. In addition, the investigators want to~     study which of the variables that are addressed in their intervention are responsible for the~     potential changes observed.~      The investigators expect that their treatment program will be effective to reduce pain in the~     short, medium and long term.~   "
68050|NCT02676219|"~     The study design is a randomised, split mouth, blind with respect to study analysts~     (microscopist, image grader) two treatment clinical study in 10 healthy participants with~     sound tooth enamel. The study will comprise of a screening visit, pre-baseline visit and 5~     subsequent clinic visits. At the screening visit, participants will give consent to~     participate in the study. Medical history and concomitant medications will be recorded.~     Eligibility will be determined following an oral soft tissue (OST) examination and an~     evaluation of dentition exclusions. Two suitable anterior teeth will be identified for study~     assessments, these teeth must be at least one tooth apart in the mouth. Saliva samples will~     be collected from the participants at set points during the study to look at any changes in~     salivary pH.~   "
68051|NCT02676206|"~     The investigators propose to determine whether listening to classical music during a sedation~     procedure decreases the need for procedural sedation medication. It is a two arm study~     comparing music vs no music by headphones so that the investigator is blinded to the~     intervention. The outcome variable is amount of sedative used and self-reported anxiety level~     as reported on a 10 point visual analogue scale (VAS). The music intervention is begun 1~     minute prior to the sedation procedure and continued until the subject is completely awake.~     Demographics will be collected for all patients. No identifiers are collected. Data will be~     compared for a change in VAS variable using non parametric methods.~   "
68103|NCT02675530|"~     This study investigates the common features of electrophysiological measures in schizophrenia~     and effects of NMDA antagonist ketamine in healthy volunteers.~   "
80432|NCT02514122|"~     A randomized double blind control trial to investigate the safety and efficacy of~     subcutaneous ketamine for control of post operative pain in low resource settings.~   "
68053|NCT02676180|"~     DETECT I is a prospective multicentre observational diagnostic study to assess the~     performance of the UroMark assay to rule out bladder cancer in patients with haematuria. The~     study will recruit consecutive patients attending haematuria clinics as well as patients~     referred to urology outpatient clinics for investigation of haematuria. Consenting patients~     will be provided with a urine sample collection kit and asked to provide a urine sample. An~     additional urine sample for control assay testing will be provided after the clinic~     attendance.~   "
68054|NCT02676167|"~     This developmental research grant award (R21) requests funds to explore the feasibility and~     impact of a public health system PrEP intervention in a recently emerging HIV epidemic in~     Athens Greece. The investigators propose a modeling approach using an Agent Based Model (ABM)~     that moves beyond basic pathogen and transmission patterns to dealing with complex social~     interactions, including overlapping social and sexual networks as well as implementation~     realities, like finite PrEP resources, delayed linkage to PrEP care and early PreP care~     retention based upon empirically collected data in Athens Greece.~   "
68055|NCT02676154|"~     This study will be investigating the effects of fesoterodine on autonomic dysreflexia (AD) in~     patients with spinal cord injuries (SCI). The goal of the study is to examine the effect of~     increasing daily use of fesoterodine on episodes of high blood pressure triggered by urinary~     bladder contractions.~   "
68056|NCT02676141|"~     This study evaluates if the German Version of the NDI is sensitive to change over time.~   "
68057|NCT02676128|"~     Inadequate adherence to antiretroviral therapy (ART) can impede successful viral suppression~     and consequently lead to negative health consequences. This study aims to refine and test the~     efficacy of a mobile health ART adherence application (ARTAA), delivered over a smartphone,~     with helping individuals improve their ART adherence.~   "
68058|NCT02676115|"~     This is a prospective, single-blinded, two-arm, randomized, parallel, pragmatic,~     effectiveness trial that will enroll patients undergoing arthroscopic anterior cruciate~     ligament reconstruction in order to evaluate the efficacy of using Medipore tape to improve~     cosmetic wound healing and scaring.~   "
68059|NCT02676102|"~     The primary purpose of this 3-phase mixed methods design study is to investigate how~     presenting content at varying levels of audience specificity (generic, targeted, and~     tailored) influences organ donor registration behavior among black men using video-based~     educational programming produced and distributed in partnership with our network of Black~     Owned Barbershops (BOBs). Investigators have completed a development phase using digital~     video interviewing to both derive and provide culturally specific content for the videos.~     This phase of this investigation is a 3 arm randomized control trial (RCT) phase, in which~     customers will be randomized to receive the generic, targeted, or tailored video programming~     delivered with iPads, after which an immediate organ donation opportunity will be offered~     through registration online or with a mailed in application. The final phase of this~     investigation will be a failure analysis whereby we will interview a subset of participants~     who registered or failed to register one month after their educational session to ascertain~     how the programming impacted their decision (Aim 3 - the subject of a future IRB~     application).~   "
68060|NCT02676089|"~     The purpose of this study is to evaluate the superiority of CHF 5993 200/6/12.5 µg pMDI~     (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate plus~     glycopyrronum bromide) versus CHF 1535 200/6 µg pMDI (fixed combination of extrafine~     beclometasone dipropionate plus formoterol fumarate) and to compare the effect of CHF 5993~     200/6/12.5 µg pMDI vs CHF 5993 200/6/12.5 µg plus open-label Tiotropium 2.5µg, in terms of~     lung functions parameters and rate of exacerbations, as well as to assess its safety and some~     health economics outcomes.~   "
68061|NCT02676076|"~     The purpose of this study is to evaluate the superiority of CHF 5993 100/6/12.5 µg pMDI~     (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate plus~     glycopyrronum bromide) versus CHF 1535 100/6 µg pMDI (fixed combination of extrafine~     beclometasone dipropionate plus formoterol fumarate), in terms of lung functions parameters~     and rate of exacerbations, as well as to assess its safety and some health economics~     outcomes.~   "
68062|NCT02676063|"~     The primary objective is to evaluate neonatal characteristics, and biological and clinical~     investigations as predictive factors of death, or of severe and moderate neurodevelopmental~     disability at 3 years, in a large population-based cohort of full-term and late preterm~     neonates with moderate or severe HIE.~      Contrary to most previous studies which have often analyzed the accuracy of one factor among~     all other clinical investigations, the investigators objective's is to seek a relevant~     combination of several factors among the following list:~        -  Neonatal characteristics: gestational age and birthweight, maternal disease, acute~          intrapartum event, delivery mode, acidosis, neurological examination, place of birth and~          neonatal transfer~        -  Laboratory investigations: pH, lactates and new biological markers as detailed below~        -  Clinical investigations: aEEG, EEG, MRI, diffusion-weighted MRI~   "
68063|NCT02676050|"~     Lung cancer is currently a major health problem in the UK. Despite being one of the most~     common cancers, lung cancer has a poor prognosis compared to other types of cancer and is the~     leading cause of cancer death in the world. As opposed to other organs, the lung is highly~     susceptible to inflammatory insults, for example from bacterial infection-induced and~     tobacco-induced inflammation. It has long been known that the cellular microenvironment that~     nurtures tumour growth and development is linked to sites of chronic inflammation but~     molecular insights into how external inflammation boosts or inhibits cancer in the lungs~     remains unclear. This study aims to directly visualise the expression of a well known marker~     of cancerous tissue, c-MET, and the activity of neutrophils in human lung cancer in vivo in~     situ using fibre-based endomicroscopy.~   "
68064|NCT02676037|"~     Hallux Vagus is a common deformity which affects the first metatarsalphalangeal joint. The~     current diagnostic tool is using X-ray which is expensive and includes radiation exposure.~     The current study is aimed at using the foot pressure platform as an alternative method for~     diagnosis and evaluation of the deformity. The main subjects will be recruited from~     orthopaedic outpatient clinics.~      The recruited subjects will undergo the non-invasive and radiation free study by walking on a~     pressure platform. Then their pressure data will be correlated with their radiological study~     which has already been done in the clinic. The aimed outcome of the study is use the foot~     pressure platform as first line of diagnosis and evaluation of the Hallux Valgus deformity.~   "
68065|NCT02676024|"~     In-hospital pediatric cardiac arrest is an important public health problem affecting almost~     6000 children a year in the United States. As many as 3% of patients admitted to a children's~     hospital require cardiopulmonary resuscitation (CPR). Only a minority of children survive, of~     which around 35% go on to have a poor neurological outcome. International consensus~     guidelines on science and treatment recommendations for the management of pediatric~     resuscitation have existed for decades and are revised periodically by the International~     Liaison Committee on Resuscitation (ILCOR) based on available evidence. This consensus is~     then used by national councils such as the American Heart Association (AHA) and the Heart and~     Stroke Foundation of Canada (HSFC) to make guidelines for care. These guidelines focus on a~     structured approach to resuscitation, which emphasizes the rapid implementation of key~     interventions such as starting chest compressions, administering epinephrine and~     defibrillation. The goal of this study is to improve outcomes after cardiac arrest in~     children by improving adherence to consensus guidelines. The investigators aim to achieve~     this by conducting a multi-center, prospective, factorial randomized study with participating~     sites from the International Network for Simulation-based Pediatric Innovation, Research and~     Education (INSPIRE).~      The specific aims of this study are to:~        1. To evaluate the effectiveness of knowledge-based cognitive aids, namely the Pediatric~          Advanced Life Support (PALS) algorithm cards, in healthcare teams.~        2. To evaluate the effectiveness of teamwork-based cognitive aids, namely the Cognitive~          Aids with Roles Defined (CARD) system, in healthcare teams.~        3. To determine if there is a synergistic effect when adding the CARD system to the use of~          knowledge-based cognitive aids or indeed whether using both these tools together has~          unintended consequences and reduces the added value of each technique.~        4. To identify whether additional simulation-based team training in the use of cognitive~          aids results in a significant improvement in performance over an e-learning module.~      The investigators hypothesize that (i) knowledge-based cognitive aids will significantly~     improve the performance of healthcare teams in providing PALS in a simulated setting, (ii)~     that teamwork-based cognitive aids (CARD) will significantly improve the performance of~     healthcare teams in providing PALS in a simulated setting, and that (iii) adding the CARD~     system to knowledge-based aids will have an added and synergistic effect, (iv) that the team~     performance in all study arms will improve after simulation based training, but that the~     groups with cognitive aids will continue to out-perform the groups without cognitive aids.~   "
68066|NCT02676011|"~     Cardiac arrhythmias are a well-recognized complication of anesthesia for laparoscopy. The aim~     of this study was to evaluate the efficacy of atropine sulfate for prevention of brad~     arrhythmia induced by repeated succinylcholine during gynecological laparoscopic surgery.~   "
68067|NCT02675998|"~     This phase 3, 8-week, randomized, double-blind, parallel group, multi-center study with a~     4-week, placebo-controlled, randomized withdrawal period will evaluate the efficacy, safety~     and tolerability of Tenapanor to treat hyperphosphatemia in end-stage renal disease patients~     on hemodialysis (ESRD-HD). Subjects who qualify are randomized into the study will either~     receive 3 mg BID, 10 mg BID, or a titration regimen of tenapanor.~   "
68068|NCT02675985|"~     This study will investigate the safety and feasibility of early intensive physical therapy~     for patients diagnosed with subarachnoid hemorrhage. Intervention will begin in the~     neurological ICU and continue for 30 days or hospital discharge.~   "
68069|NCT02675972|"~     Previous studies on the association between blood pressure variation (BPV) in acute ischemic~     stroke and functional outcomes yield conflicting result. The obscured definition and~     measurement of BPV engenders considerable confounding factors, making it difficult to~     interpret. We aim to investigate the predictive role of 24-hour BPV on early outcomes in~     acute non-cardiogenic ischemic stroke.~   "
68070|NCT02675959|"~     This is a follow-up trial to NYMC 526 (NCT01461837) to assess the safety, efficacy and~     toxicity of administering Defibrotide prophylaxis for high-risk sickle cell patients~     undergoing a familial haploidentical allogeneic stem cell transplantation with CD34~     enrichment and T-cell addback. This patient population historically has a risk of developing~     sinusoidal obstructive syndrome (SOS) and Defibrotide has demonstrated efficacy in treatment~     of SOS.~   "
68071|NCT02675946|"~     This is a multicenter, open-label study conducted in two phases: Phase 1 consisting of a~     CGX1321 Single Agent Dose Escalation Phase in solid tumors and Dose Expansion Phase in GI~     tumors and Phase 1b consisting of CGX1321 in combination with pembrolizumab in colorectal~     tumors. Both phases are to evaluate safety, pharmacokinetics, and clinical activity.~   "
68072|NCT02675933|"~     This study is a randomized controlled trial utilizing a patient-centered questionnaire~     distributed to parents of children with autism. The study arm will receive the questionnaire~     and will be compared to the control arm, which will receive standard of care. The results of~     satisfaction surveys will be the primary endpoint of this study.~   "
68073|NCT02675920|"~     The purpose of this study is to compare sensitivity for hepatocellular carcinoma (HCC) of~     bi-annual ultrasonography and low dose computed tomography (LDCT) in patients at high risk of~     HCC.~   "
68074|NCT02675907|"~     The primary objective of this study is to evaluate the analgesic efficacy of N1539 in~     subjects with acute moderate to severe pain following unilateral bunionectomy.~   "
68075|NCT02675894|"~     To determine safety, ablative zone, technical success rate and early safety data of recently~     introduced cool-wet electrode in eligible patients who are indicative for radiofrequency~     ablation (RFA) for liver tumors.~   "
68076|NCT02675881|"~     Increasing ablative zone is an essential part to improve technical success and long term~     outcome in patient treated with radiofrequency ablation (RFA).~      A combination of dual switching system and separable clustered electrode has been reported to~     create large ablative zone in preclinical study.~      Based on preclinical study, the investigators conducted a preliminary study in eligible 60~     patients to measure whether this combination (dual switching system and separable clustered~     electrode) improves technical success rate and local tumor progression rate over a year, in~     comparison with historical control group.~   "
68077|NCT02675868|"~     Noradrenaline is a catecholamine and the cornerstone treatment for the improvement of~     hemodynamic parameters in septic shock. Catecholamines exert profound immunomodulatory~     effects. Noradrenaline in vitro inhibits LPS-induced pro-inflammatory cytokine production,~     however, the actions on immune function in vivo have not been assessed. Furthermore, effects~     on the immune system of viable vasopressor alternatives for the treatment of septic patients,~     namely phenylephrine and vasopressin, need to be established in humans in vivo.~   "
68078|NCT02675855|"~     The objective of the study is to compare the efficacy of weekly GrafixPRIME® administration~     to an Active Comparator in patients with chronic DFUs in a randomized, single-blind study.~   "
68104|NCT02675517|"~     The primary objective of the study is to measure changes in physical functioning - serving as~     a surrogate for physical activity and exercise capacity - in COPD patients being treated with~     Spiolto® Respimat® after approximately 6 weeks. A secondary objective is to evaluate the~     patient¿s general condition (physician¿s evaluation) at visit 1 (baseline visit at the start~     of the study) and at visit 2 (final visit at the end of the study, approx. 6 weeks after~     visit 1), as well as patient satisfaction with Spiolto® Respimat® at visit 2.~   "
87622|NCT02420171|"~     Add insulin to a single step culture media for IVF embryo culture from day 0 to day 5/6 of In~     Vitro culture and detect the the effect upon embryo quality and implantation potential.~   "
68079|NCT02675842|"~     Radiation therapy to the chest is used in late stage lung cancer, and it often leads to~     inflammation of the esophagus. The inflammation is expected to occur in about 75% of patient,~     and usually begin within a week of starting radiation therapy. The esophagitis causes pain~     and difficulty eating. It can also result in stopping or delaying treatment.Radiation therapy~     to the chest is used in late stage lung cancer, and it often leads to inflammation of the~     esophagus. The inflammation is expected to occur in about 75% of patient, and usually begin~     within a week of starting radiation therapy. The esophagitis causes pain and difficulty~     eating. The endocannabinoid system is prominent in the gastrointestinal system, and cannabis~     has been shown to greatly inhibit inflammation. The compound~     (−)-trans-Δ9-tetrahydrocannabinol (Δ-9-THC) has effects that reduce inflammation and pain.~     Cannabidiol is a component of cannabis that does not produce subjective or intoxicating~     effects, but also has prominent anti-inflammatory properties.~      The goal of this study is to perform a double-blind, placebo-controlled study to investigate~     the efficacy of cannabis, compared to placebo, in participants undergoing RT (Radiation~     Therapy) for lung cancer. Cannabis that has a high concentration of cannabidiol will be used~     , which is a cannabinoid that does not change perception or produce intoxication, and low in~     Δ-9-THC. In this way, the hope is to maximize the benefit of cannabis, while lowering the~     possible side effects of cannabis in medically ill participants.~   "
68080|NCT02675829|"~     The purpose of this study is to find out what effects, a drug called ado-trastuzumab~     emtansine has on the patient and their cancer which is thought to be controlled by the~     abnormal HER2 gene.~   "
68081|NCT02675816|"~     The purpose of this post-market study is to assess safety and effectiveness of Inspire Upper~     Airway System (UAS) in a commercial setting. This study will provide additional clinical~     evidence of Inspire UAS for treatment of moderate to severe obstructive sleep apnea (OSA)~     using a randomized controlled trial design.~   "
68082|NCT02675803|"~     This study will investigate the safety and tolerability of VAY736 administered as single~     ascending doses of intravenous infusion, subcutaneous injection and repeated subcutaneous~     injections in rheumatoid arthritis patients.~   "
68083|NCT02675790|"~     The overall goal of the proposed study is to determine the effectiveness of hydroxyurea~     therapy for secondary stroke prevention and prevention of other neurological events in~     children with SCA with an acute overt stroke.~   "
68084|NCT02675777|"~     Alcohol use is the third greatest cause of disability and death for US adults. Care for~     unhealthy alcohol use is lacking in most primary care settings. This project will implement~     two types of evidence-based care for unhealthy alcohol use in the 25 primary clinics of a~     regional health system—Group Health (GH). These include preventive care and treatment.~     Preventive care consists of alcohol screening, and for patients who screen positive, brief~     patient-centered counseling. Treatment for alcohol use disorders includes offering shared~     decision making and motivational counseling designed to enhance engagement in one or more~     treatment options: counseling, medications, and/or specialty treatment. During a pilot phase,~     the research team at Group Health Research Institute partnered with Group Health leaders and~     front line clinicians to design, pilot test, and iteratively refine an implementation~     strategy in 3 Group Health primary care clinics.~      Objective~      This study uses state-of-the-art implementation strategies to integrate evidence-based~     alcohol-related care into 22 primary care clinics (detailed below). This study is a pragmatic~     stepped-wedge quality improvement trial to evaluate its impact on:~        1. The proportion of patients who have primary care visits who screen positive for~          unhealthy alcohol use and have documented annual brief alcohol counseling;~        2. The proportion of patients who have primary care visits who have AUDs identified, and a)~          initiate and b) engage in care for AUDs.~      Secondary outcomes will include:~        1. The proportion of patients who have primary care visits who have documented annual~          alcohol screening with the AUDIT-C; and~        2. The proportion of patients who have primary care visits who screen positive for severe~          unhealthy alcohol use and have AUDs assessed and/or diagnosed;~   "
68085|NCT02675764|"~     The objective of this pilot project is to assess the impact of the novel sensory stimulation~     technique the investigators have developed in enhancing outcomes of hand therapy as well as~     the central nervous system responsiveness in chronic stroke survivors.~   "
68086|NCT02675751|"~     Prospective, multicenter, bilaterally-treated, open-label, non-randomized clinical trial.~   "
68087|NCT02675738|"~     Prospective, observational, cohort study to evaluate the reliability of preoperative work-up~     of patients submitted to surgery for pancreatic cystic neoplasms, in a tertiary referral~     center. A comparison between the preoperative diagnostic suspicion and the final pathologic~     report will be done.~   "
68088|NCT02675725|"~     Fluid therapy is one of the cornerstones of the treatment of organ failure. The investigators~     assume that fluid bolus will increase the delivery of oxygen to the cells and resolve the~     shock.~      The purpose of this study is to asses kinetics of the sublingual microcirculation in one~     place during a fluid bolus. It is expected that fluid therapy after normalization of the red~     blood cell flow velocity in the microcirculation will result in a decrease in capillary~     density through the formation of edema in the tissues. This can be considered to be the~     tipping of potentially beneficial to deleterious effects of fluid therapy.~      After cardiac surgery patient will be transferred to the ICU for further stabilisation.~     Within specific indications the patient will receive a fluid bolus, these indications are~     hypotension, hyperlactataemia, tachycardia or decreased urine production. The fluid bolus~     will be 250 ml crystalloids in 15 minutes. The investigators will observe the sublingual~     microcirculation during this fluid bolus. To asses the red blood cell velocity and capillary~     vessel density on one spot during this fluid bolus.~   "
68089|NCT02675712|"~     This pilot study evaluated whether participating in an African drumming activity for 45~     minutes immediately improved mental well-being among 13 adults diagnosed with acute mood~     disorders who were attending a private mental health clinic. The drumming intervention was~     completed by occupational therapists.~   "
68090|NCT02675699|"~     This study will test whether parent engagement (recruitment, attendance) in a Childhood~     obesity prevention programme (HENRY) can be improved in local authorities randomised to~     receive an Optimisation intervention (in addition to standard HENRY) compared to those~     continuing to deliver the programme as standard.~   "
68091|NCT02675686|"~     The discovery of antenatal bilateral renal anomaly poses an essential question: can we~     predict postnatal renal function in short, medium and long term? Ultrasound appears~     sufficient in severe or mild forms. In the Intermediaries form (normal size dysplastic~     kidneys with persistence of amniotic fluid), ultrasound and current markers do not predict~     postnatal renal function evolution.~      The objective of this study is to estimate the specificity and sensitivity of amniotic~     biomarkers profile in the diagnosis of renal functionality in fetuses with bilateral~     nephropathy development.~   "
69408|NCT02658461|"~     This prospective, non-interventional time and motion study will evaluate the costs of~     healthcare resource utilization associated with the administration of trastuzumab (Herceptin)~     SC and IV formulations in HER2-positive EBC. This is a sub-study of the clinical study~     MO22982 (NCT01401166/PrefHer).~   "
68092|NCT02675673|"~     The purpose of this study is to compare the quality of life (QOL) in head and neck patients~     who are given the GJ tube (which is placed in the bowel) versus those who are given the~     G-Tube (which is placed in the stomach) for prophylactic feeding. The standard of care for~     patients at Princess Margaret Hospital (PMH) is using GJ tubes. Patients who agree to be in~     the study will be randomized to either the GJ-Tube or the G-Tube arm. Patients randomized to~     the G-tube will receive prophylactic intravenous and oral antibiotics prior to insertion of~     the G-tube. Antibiotics will be given for a total of 1 week. A few hours following tube~     insertion (on return to PMH ward), patients will complete a single item, visual analogue pain~     scale (VAS). Patients will remain in hospital for a minimum of 24 hours and until the patient~     and/or family is able to care for the Enteric Feeding(EF) device at home. Patients randomized~     to the GJ-Tube may receive i.v medication during the procedure. All Patients will be asked to~     fill out several questionnaires at different time- points of the study. All Patients will~     have regular assessments to evaluate their overall quality of Life, toxicity, and how they~     respond to treatment during the study. Patients will also be assessed after they completed~     study treatment.~   "
68093|NCT02675660|"~     This study represents an initial clinical evaluation of an oral formulation of~     L-homoarginine. L-homoarginine and L-arginine are amino acids found in food proteins and are~     both substrates for nitric oxide synthase (NOS). L-arginine is available as over the counter~     nutraceutical. This study will provide information on the dosing of L-homoarginine in order~     to reach high physiological plasma concentrations in humans.~   "
68094|NCT02675647|"~     The optimal heparin regimen during cardiopulmonary bypass (CPB) has not been well established~     in obese patients.~      Results of a preview study show that the standard heparin management based on total body~     weight in obese patients during CPB resulted in excessive heparin level, which could lead to~     excessive postoperative bleeding.~      To avoid this overdosing, an initial heparin bolus based on ideal body weight in obese~     patients was proposed.~      The main objective of the study is to evaluate the effects of heparin injection, based on~     ideal body weight, on intraoperative plasma heparin levels and activated coagulation time~     (ACT) in a population of obese patients, compared to a group of obese patients undergoing CPB~     surgery with heparin management based of total body weight.~      The secondary objectives are to evaluate the relationship between heparin level and ACT in~     each group of patients and at different time points during CPB, and to compare the incidence~     of bleeding, intraoperative transfusions and complications in the two groups of patients.~   "
68095|NCT02675634|"~     This clinical investigation is intended to explore the performance and safety of two newly~     developed ostomy products with regard to the products fit to body properties.~   "
68096|NCT02675621|"~     An acute, randomized, placebo controlled, double blinded crossover study in health subjects.~     Participants will complete 4 intervention arms in random order consisting of a placebo~     control beverage, a high dose phenolic beverage, a high dose phenolic beverage combined with~     a fruit extract, and a low does phenolic beverage. The primary objective of the study is to~     assess the effects of the phenolic compounds, at two different levels, alone and in~     combination with a fruit extract, on mood and cognitive performance during extended periods~     of cognitively demanding task performance.~   "
68097|NCT02675608|"~     This study evaluates the effectiveness of the seasonal flu vaccine in adults of different~     ages and diabetic disease statuses. These studies will help our understanding of how chronic~     inflammatory diseases impact immunologic function and future research on mitigation~     strategies.~   "
68098|NCT02675595|"~     Hypothesis:~      In Women in the second trimester of pregnancy 5D offers an alternative method for fetal~     Echocardiography compared to conventional 2D scanning~      Question:~      Does 5D software technology is as efficient as 2D scanning in fetal echocardiography of~     second trimesteric fetuses?~      Aim:~      This study aims at assessing the accuracy of performance of the 5D as a new scanning~     technology in fetal Echocardiography compared to the conventional use of 2D scanning.~   "
68099|NCT02675582|"~     The primary objectives of this study are to assess the effects of three investigational~     drinks containing three botanicals in differing combinations versus a placebo control, on~     mood, psychological state, physical response, and cognitive performance during and after~     exposure to an observed multi-tasking stressor.~   "
68100|NCT02675569|"~     This pilot randomized controlled trial (RCT) is multi-center, parallel-arm, and open label.~     It will test the feasibility and safety of randomizing elderly patients with end-stage kidney~     failure starting hemodialysis with a tunneled/non-tunneled catheter to one of the following~     vascular access strategies: (a) attempt at fistula creation (intervention), or (b) continued~     use of a catheter (comparator). A total number of 100 participants will be enrolled in this~     pilot RCT. The rationale for this trial includes: (1) the importance of the intervention~     question related to the choice of vascular access for patients treated with hemodialysis; (2)~     lack of evidence from clinical trials for decision-making in this area (only observational~     studies are available); (3) existing studies which suggest that fistula use is associated~     with better patient outcomes are very prone to selection bias; (4) need for a clinical trial~     comparing the impact of the two most frequently chosen strategies for vascular access~     (catheter and fistula) in the hemodialysis population; and (5) a feasible and safe trial~     design. The results obtained from this pilot RCT will determine the feasibility and safety of~     conducting a large RCT, which will be powered for the primary outcome of all-cause mortality.~   "
68101|NCT02675556|"~     This study is intended to evaluate the safety and potential efficacy of Allogeneic Human~     Mesenchymal Stem Cell Infusion versus placebo in patients with Treatment Resistant~     Depression.~   "
68102|NCT02675543|"~     The inflammatory response after prolonged retinal detachment and after vitreoretinal surgery~     has its apex in the development of PVR that occurs when retinal cells are exposed to the~     inflammatory milieu in the humor vitreous.~      This situation is common in complicated retinal detachment, but is amplified after invasive~     surgery and by the use of intraocular tamponades that float over a subtle film of liquid~     where the inflammatory cytokines and growth factors reach the critical concentration over the~     inferior retina.~      Many authors have noted that the heavy tamponade are more prone to cause intraocular~     inflammation compared to standard silicone oil, especially if they remain for several months~     in the eye.~      The purpose of this study is to measure the vitreous concentration of some of the most~     important cytokines involved in the inflammatory vitreal response.~   "
68105|NCT02675504|"~     Since the 2000s, the experiences of children and especially their fear during a consultation,~     a treatment or examination is food for thought in our establishment. There is no tool~     validated self-assessment of fear to 6 faces. It therefore appeared necessary to us to create~     this tool. The scale self-assessment of the fear that we have developed consists of six faces~     representing a gradual level of fear: the child can easily describe their level of fear,~     which allows for appropriate care.~   "
68106|NCT02675491|"~     This is a Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of~     DS-6051b in Japanese subjects with advanced solid malignant tumors harboring either a ROS1 or~     NTRK fusion gene.~   "
68107|NCT02675478|"~     This is a dose escalation study to evaluate the safety, tolerability, and pharmacokinetics of~     quizartinib for Japanese acute myeloid leukemia (AML) subjects.~   "
68108|NCT02675465|"~     This study is an international, multi-center, study of Pompe disease patients that are~     currently receiving enzyme-replacement therapy (ERT). The purpose of this study is to find~     out if the co-administration of investigational new drugs ATB200 and AT2221 is safe in adults~     with Pompe disease.~   "
68109|NCT02675452|"~     At least one dose level of AMG 176 will achieve acceptable safety and tolerability in~     subjects with relapsed or refractory multiple myeloma and subjects with relapsed or~     refractory acute myeloid leukemia~   "
68110|NCT02675439|"~     The purpose of this study is to characterize the safety, tolerability, pharmacokinetics,~     pharmacodynamics and antitumor activity of MIW815 (ADU-S100) administered via intratumoral~     injection as a single agent and in combination with ipilimumab.~   "
68111|NCT02675426|"~     This is a multi center, randomized, double-blind, placebo-controlled phase 3 study in~     subjects with moderately to severely active rheumatoid arthritis on a stable dose of csDMARDs~     who have had an inadequate response to csDMARDs.~   "
68112|NCT02675413|"~     This is a prospective study that will explore the mechanisms of efficacy of dimethyl fumarate~     (DMF) treatment in multiple sclerosis (MS). Investigators will enroll relapsing MS patients~     who are beginning therapy with DMF into a one-year longitudinal study in which blood and~     spinal fluid analyses, imaging and clinical studies will be performed to identify and measure~     changes associated with DMF therapy.~   "
68113|NCT02675400|"~     In contrast to mothers with Attention Deficit/Hyperactivity Disorder (ADHD), the impact of~     paternal ADHD in families and children with ADHD symptoms has not been studied, despite the~     prevalence of ADHD in males. Thus, the investigators do not know the feasibility, impact on~     treatment on the family and child, and effects of treating fathers relative to mothers with~     ADHD. Paternal ADHD is associated with negative parenting and child conduct problems.~      The investigators hypothesize that successfully treating parental ADHD in fathers will have a~     beneficial effects on the family that will extend to the child. Specifically, the~     investigators believe that stimulant medication ((Lisdexamfetamine (LDX) or a different ADHD~     medication if poor response to LDX) with fathers will reduce father's ADHD symptoms and~     improve parenting. Effects of stimulant treatment of fathers will be compared to Behavioral~     Parent Training (BPT) on parenting, and paternal and child outcomes in fathers with ADHD who~     have children between the ages of 3 -8.~      As in the investigator's previous work, the investigators will bank paternal and child DNA~     and RNA for later examination of pharmacogenetic and epigenetic effects (i.e. RNA) of~     stimulant response.~   "
68114|NCT02675387|"~     Children in their seventh year of life (age range of 6 to 7 years) will be included in the~     study. All children included in the study would have to classified according to the Wright~     behavior classification as potentially co-operative and rated as per the Frankl behavior~     rating scale as positive (++) Group A and negative (-) Group B . All children included must~     have had no prior experience of dental anesthesia and must have at least one tooth requiring~     restorative procedure on either side of the maxillary arch. Intervention Description~        1. Regular Anesthesia All the subjects received local anesthesia injection in maxillary~          arch as is commonly practiced in dental clinics. Information obtained before assignment~          of intervention or standard care included age, gender, type of injection given alongside~          the vibration device will be recorded beforehand. During the delivery of anesthesia for~          all the groups, anticipated and actual pain will be recorded to show the impact of~          anxiety on the experience of participants. During the entire process, all participants~          will use standard needles with confirmed specification to control for any potential~          confounders~        2. Buzzy® The use of the external cold and a vibrating Device will follow the~          manufacturer's recommendations to ensure that normal clinical scenario is created.~   "
68115|NCT02675374|"~     This single-institution randomized controlled trial prospective will enrolled 48 patients~     scheduled for an aortic valve replacement. The objective of the present investigation is to~     determine the role of Polaramine® on reducing hemodynamic instability after separation from~     cardiopulmonary bypass (CPB) during cardiac surgery. Our hypothesis is that Polaramine® play~     an important role reducing dysfunction of the autonomic nervous system and hemodynamic~     stability after separation from CPB.~   "
68127|NCT02675218|"~     Rheumatoid Arthritis patients management reposes primarily on the use of disease-modifying~     antirheumatic drugs (DMARDs).~      Among DMARDs available in 2015, researchers demonstrated the ability to reduce synovitis,~     biomarkers of inflammation, and bone destruction.~      Given the demonstration of correlation between joint inflammation and structural progression~     at each joint level as well as the opportunity for bone remodeling with resolution of joint~     inflammation, researchers expect to observe an improvement in bone micro-architecture~     parameters specifically in rheumatoid arthritis patients without remaining joint inflammation~     3 months following abatacept treatment initiation.~   "
68128|NCT02675205|"~     Part of interventional neuroradiology procedures for the treatment of selected cerebral~     aneurysms are now based on stenting. To reduce thromboembolic events, dual antiplatelet~     therapy (APT) combining aspirin and clopidogrel is proposed with close monitoring, since 1/3~     of the patients are low responders due to variation of the biological response to clopidogrel~     . Ticagrelor is used by few teams but has never been evaluated in a randomized controlled~     trial. It could be an option for APT due to more reproducible response with less~     interindividual variability and reduced monitoring. The aim of this study is to demonstrate~     the interest of ticagrelor for the dual APT for platelet inhibition, in patients undergoing~     neurovascular stenting for cerebral aneurysm.~   "
68116|NCT02675361|"~     This study is part of a larger research project known as Swedish Transition Effects Project~     Supporting Teenagers with chrONic mEdical conditionS (STEPSTONES). This project was created~     to develop and evaluate transition programs in order to support adolescents with chronic~     conditions in Sweden. While STEPSTONES has a generic nature, the first transition program~     that will be evaluated targets adolescents with congenital heart disease (ConHD).~      This particular study involves a hybrid experimental design, meaning a randomized controlled~     trial is embedded in a longitudinal, observational study. This type of design will help to~     test the effectiveness of a transition program in order to empower adolescents with~     congenital heart disease in the transition to adulthood and check for potential contamination~     of the comparison group. We will recruit 210 participants: 140 adolescents will be part of~     the randomized controlled trial (70 in the intervention arm; 70 in the comparison arm), and~     70 participants will be assigned to the observational, longitudinal arm of the study, which~     serves as control group in an intervention-naive center. Over a period of two years, three~     assessments will be done during which all participants will be asked to answer a set of~     questionnaires.~      The intervention to be tested involves patient empowerment, education on their ConHD, dealing~     with school, health behaviors required to maintain good health, guidance of parents, a~     person-centered transition plan, among others. The study hypothesis is that adolescents with~     ConHD who received a structured, person-centered transition program over a 2-year period have~     a higher patient empowerment score than adolescents who receive usual care.~   "
68117|NCT02675348|"~     The aim of this project is to investigate the potential benefits of combining a new protein~     beef hydrolysates extract with a regular endurance training programme on (a) body composition~     (b) performance (c) muscle structure (d) blood markers of health in athletes. As a second~     objective the investigators will analyse potential differences obtained from the ingestion of~     the new hydrolysates beef protein extract compared to the ingestion of others commercially~     available protein sources such as whey and non protein only carbohydrate contrast nutrients.~   "
68118|NCT02675335|"~     The purpose of the study is to test the effect of Sitagliptin on the healing of stable,~     nonhealing diabetic foot ulcers. This is a randomized placebo-controlled Trial.~   "
68119|NCT02675322|"~     Danlou tablets are Chinese patent medicine which has been approved in China for the treatment~     of ischemic heart disease, but the evidence supporting its efficacy on cardiac remodeling~     remains unclear. This pilot study was designed to determine whether Danlou tablets reduced~     adverse left ventricular (LV) remodeling in patients with acute myocardial infarction (MI).~     Patients following acute MI were enrolled and randomly allocated to Danlou tablets (4.5 g~     q.d. for 90 days) or placebo, superimposed on standard medications for the treatment of MI.~     Major end points were changes in LV volumes and ejection fractions as evaluated by serial~     echocardiography in addition to clinical outcomes were also determined.~   "
68120|NCT02675309|"~     The purpose of this study is to investigate the effect of MT-8554 on the pharmacokinetics of~     simvastatin and rosuvastatin in healthy subjects.~   "
68121|NCT02675296|"~     Acute kidney injury requiring dialysis (AKI-D) has increased considerably over last 15 years.~     The national rise in incidence of acute kidney injury has several ramifications in terms of~     cost to the health services resulting not only from cost of therapy but also from the later~     consequences of AKI from development of chronic kidney disease and cardiovascular disease.~     Mortality in patients with AKI-D is very high and remains unchanged in the last decade in~     England. In recent years it is becoming clearer that even the national incidence and~     case-fatality of AKI is influenced by regional variation. In last three decades, many studies~     have reported unwarranted variation in a wide range of procedures, from the performance of~     cesarean section and coronary angiography to the treatment of early prostate cancer, stroke,~     and the ailments of the chronically ill. In surgical care there is evidence that the~     variation may be driven by forces other than patient illness and medical appropriateness such~     as access to care and other socioeconomic factors, provider capacity of the local system,~     medical malpractice pressure, and distinctly different local practices. Despite the public~     health burden of AKI-D in England, it is unclear if regional variation exists in AKI-D.~     Variation in incidence of AKI-D in different region of a country may be influenced by patient~     and physician demographics of the regions, physician preferences or the nature of the~     hospital serving the population. To reduce the incidence and case fatality of AKI-D, it is~     imperative to understand if variations in incidence and case-fatality in AKI-D exists in~     different regions of the country.~      To address this gap in knowledge, the investigators combined national database of hospital~     admissions and discharge with census data from office of national statistic over a period of~     fifteen years to determine the trend in change in the regional incidence and case fatality of~     AKI requiring dialysis in England. The investigators also explored various determinants of~     the regional variation in the dialysis requiring AKI.~      Methods Data source The investigators extracted 2000-2015 data from the Hospital Episode~     Statistics (HES), a data warehouse containing details of all admissions, outpatient~     appointments, and A&E attendances at National Health Service (NHS) hospitals in England.~      Definitions The investigators identified all cases of AKI by using validated International~     Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes in any~     diagnoses codes, in keeping with the objective of the study. Patients with any of the~     following codes were included: N17.0 for acute renal failure (ARF) with tubular necrosis,~     N17.1 for ARF with acute cortical necrosis, N17.2 for ARF with medullary necrosis, N17.8 for~     other ARF and N17.9 for ARF, unspecified. ARF has been replaced by new terminology, AKI, but~     due to lack of ICD10 codes for AKI, the investigators used the ICD10 codes for ARF and~     henceforth, will be referred to as AKI in this study. The investigators also extracted all~     available secondary diagnosis and up to 24 Office of Population Censuses and Surveys~     Classification of Interventions and Procedures, 4th revision (OPCS-4) codes. To identify~     patients with AKI-D, the investigators included OPCS code of X40.3 for hemodialysis or X40.4~     for hemofiltration in any of the 25 procedures. Patients with chronic kidney disease stage 5~     (CKD-5) starting chronic dialysis and end stage renal disease (ESRD) with ICD-10 code of~     N18.5 and N18.6 respectively were excluded. The investigators also excluded OPCS-4 codes for~     Arteriovenous fistula (L74.2) or Arteriovenous graft (L74.3) during the inpatient admission.~     HES data stratifies patient location into 16 different regions. The geographic regions in~     England were stratified as per the Office of National Statistic (ONS) into nine regions:~     North East, North West, Yorkshire and Humber, East Midlands, West Midlands, East of England,~     London, South East and South West. Patients' in geographical locations outside these nine~     regions were excluded. Patients who were admitted, but were not discharged during the study~     period will not be included in the study. The investigators also obtained completed hospital~     discharges from each region to estimate the effect of hospitalization on AKI-D incidence~     rates, along with number of nephrology consultants in each region from 2000 to 2015 from~     Health and Social Care Information Centre (HSCIC) in the annual census of medical and dental~     staff in the NHS. The investigators will also obtain linkage with ONS and UK Renal Registry~     (UKRR) for long-term patient and renal outcomes. To obtain population incidence of AKI-D for~     each region, mid-year population of the region in each year from 2000 to 2015 was obtained~     from the ONS.~   "
68122|NCT02675283|"~     This study aims to assess whether it is feasible to use a point of care test to increase the~     detection of coeliac disease in a pharmacy setting.~   "
68123|NCT02675270|"~     The goal of this study is to remediate word-finding problems in patients who have Primary~     Progressive Aphasia (PPA) or Alzheimer's Disease and to delay the further progression of~     word-finding impairment. The current approach is novel in that it contains a prophylaxis~     component in which the investigators attempt to strengthen neural connections that remain~     functional, making them more resistant to degradation as the disease progresses. While the~     study is specific in its targeting of word-finding problems, a successful outcome would bode~     well for other studies aimed at prevention or reversal of declining cognitive functions in~     dementia. One set of participants with PPA will receive practice with picture naming in two~     conditions: viewing the picture and repeating the name; and viewing the picture with its~     written name, plus reading and writing the name. Another set of participants with PPA or~     Alzheimer's Disease will be trained in two different conditions: learning about the word's~     semantic features (meaning); and learning about the word's lexical features (letters and~     sounds). Naming of pictures trained in each of these conditions will be compared, at three~     time intervals post-training, with naming of pictures tested before the study but never~     trained. It is predicted that the pairing of the picture with its written name, combined with~     the motor task of writing the name, will result in a greater ability to name the picture at a~     later date than simple practice viewing the picture and repeating the name. Furthermore, it~     is predicted that participants who have difficulty understanding concepts will be more likely~     to respond to semantic treatment, while participants who have difficulty connecting words~     with concepts will be more likely to respond to lexical treatment.~   "
68124|NCT02675257|"~     This randomised controlled trial evaluates a cognitive-behavioural intervention for diabetes~     patients with suboptimal glycaemic control and comorbid depressive symptoms and/or diabetes~     distress. The main outcome is the improvement of suboptimal glycaemic control (HbA1c).~     Secondary outcomes are effects on depressive symptoms, diabetes distress, self-care~     behaviour, diabetes acceptance and quality of life. The treatment group will be treated with~     a cognitive-behavioural group treatment comprising specific interventions to improve~     glycaemic control and reduce diabetes distress as well as depressive symptoms. The control~     group will receive treatment-as-usual. A total of 212 study participants will be included. A~     secondary study objective is to analyse associations of suboptimal glycaemic control,~     depressive symptoms and diabetes distress with inflammatory markers.~   "
68125|NCT02675244|"~     The purpose of the research is to determine whether repairing a tricuspid valve (TV) in~     patients with mild to moderate tricuspid regurgitation (TR), at the time of planned mitral~     valve surgery (MVS), would improve the heart health of those who receive it compared to those~     who do not.~      At this point, the medical community is split in their opinion on whether surgeons should~     routinely repair mild to moderate TR in patients who are undergoing planned mitral valve~     surgery, and this study will answer this question.~   "
68126|NCT02675231|"~     The purpose of this study is to evaluate the effectiveness of abemaciclib plus trastuzumab~     with or without fulvestrant or chemotherapy in women with hormone receptor positive (HR+),~     human epidermal growth factor receptor 2 positive (HER2+) locally advanced or metastatic~     breast cancer after prior exposure to at least two HER2-directed therapies for advanced~     disease.~   "
68129|NCT02675192|"~     Aging affects almost all the tissues and physiological functions, and skeletal muscle is the~     most affected organ. The progressive decline of the weight and the muscular function linked~     to the aging contributes to the lack of autonomy and dependence, but also to an increase of~     the mortality risks. Sarcopenia is also a prevalent condition, because it is detected in~     13-24% of 60 years old, and 50% of 80 years old and more.~      However, strong inter-individual variations of this prevalence of sarcopenia exists. The key~     issue is to understand why the biological aging of the skeletal muscle is so different~     between people.~      In this study, mechanisms involved in biological aging of the skeletal muscle in aging people~     (same chronological age) will be specified.~   "
68130|NCT02675179|"~     The aim of this study is to demonstrate in vivo the concordance of the imagery system EOS and~     the spiral CT in women having had an obstructed delivery. If this concordance is~     demonstrated, it would allow the use of this new technique of imagery, to realize a~     pelvimetry during the pregnancy less irradiating for the mother, and the fetus.~   "
68131|NCT02675166|"~     Children cancers are rare and survival rate are around 75%. 1 French adult out of 850 is~     estimated as a children-cancer-survivor. Chemotherapy, radiotherapy or surgical complications~     can lead to a late risk of death. A regularly support, a therapeutic education, a support of~     the psychological difficulties have a positive impact on the quality of life and on long-term~     health for patients surviving to a cancer.~      The ARCERRA exists, registering around 150 new cases a year. They coordinated, from 2011 to~     2014, a multicentric study with a long term follow up in oncology (SALTO). 150 patients~     diagnosed between 1987 and 1992 were included, and the study demonstrated the feasibility and~     utility for patients and their physicians of a long-term follow-up coupled with an interview~     with a psychologist in Rhône-Alpes-Auvergne.~      The primary objective of SALTO-2 project is to know the becoming of young adults that~     survived to pediatric cancer, diagnosed in Rhône-Alpes between 1993 and 1999. The second~     objective is in one hand to study the psychological becoming and on another hand, to~     ameliorate their lifestyle thanks to different documents created specially for them.~   "
68132|NCT02675153|"~     Crohn's disease （CD） with stenosis has limited therapeutic options and with high surgical~     rate. The present clinical trial aims to evaluate the efficacy and safety of sirolimus in the~     treatment of stricturing Crohn's Disease.~   "
68133|NCT02675140|"~     The present study is intended to supplement the preschool anemic children with vitamin A~     capsule and de-hookworm administration in poverty Sichuan province. We eventually expect our~     study can provide a cost-effective, safe and more beneficial public health strategy to manage~     the anemia status of preschool children in poverty area.~   "
68134|NCT02675127|"~     An open label randomized, single dose, two-way crossover bioequivalence study to determine~     the bioequivalence of Daclatasvir from Daktavira 60 mg film coated tablets ( European~     Egyptian Pharmaceutical Industries, Egypt) versus Daklinza 60 mg tablets (Bristol-Myers~     Squibb Pharma, UK) in Healthy Human Volunteers Under Fasting Condition~   "
68135|NCT02675114|"~     To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve~     in patients with severe, calcific aortic stenosis who are at low operative risk for standard~     aortic valve replacement (AVR).~   "
68136|NCT02675101|"~     Persistent organic pollutants (POPs) are mostly fat-soluble halogenated chemicals with very~     long half-lives. POPs are endocrine disruptors, associated with increased risk for diabetes,~     alterations in thyroid function, and cardiovascular disease in humans. POPs concentrations~     increase with age because of their persistence, bioaccumulation and poor excretion. The~     almost ubiquitous presence of endocrine disrupting POPs in US adults is a substantial public~     health concern, particularly because there is no established treatment to reduce body~     concentrations of POPs. Most POPs are excreted in bile due to their lipophilic nature.~     However, a substantial amount is reabsorbed in the small intestine and returns to the blood~     stream (entero-hepatic circulation). The objective of this pilot study is to conduct a~     6-month randomized controlled trial of Nuts and Olestra to enhance the excretion of POPs~     among 45 healthy adults aged 45 to 70 years with BMIs between 18-30 kg/m2. This study has 3~     treatment arms: A) Whole nuts with high fat content (almonds and walnuts; 110g total/day,~     n=15), B) Olestra: Fat Free PringlesTM potato chips (≈29 crisps, 18g of Olestra/day; n=15),~     C) Vegetable oil: Original PringlesTM potato chips (≈29 crisps, 17.4g of oil/day; n=15). The~     investigators aim to measure change in concentrations of 24 POPs in feces after 4 days of~     treatment and in blood at 6 months.~   "
68137|NCT02675088|"~     Most patients with extensive stage small-cell lung cancer (ES-SCLC) who undergo chemotherapy,~     and prophylactic cranial irradiation, have persistent intrathoracic disease. A Dutch study~     recently proved that thoracic radiotherapy(TRT), using 30 Gy in 10 fractions of 3 Gy, could~     improve 2-year overall survival(OS) of this patient group compared with non-TRT group. But~     intrathoracic progression was still high, either with or without progression elsewhere,~     occurring in 43.7% in the TRT group. The ideal TRT regimen for ES-SCLC is undefined. Maybe~     higher dose can provide better local control(LC) and overall survival. In this study, the~     investigators propose to give an increased dose of TRT to determine whether higher dose will~     improve 2-year OS, LC and progression-free survival.~   "
68138|NCT02675075|"~     A disease called Amyotrophic lateral sclerosis (or ALS), which leads to difficulty~     swallowing, breathing, and movement, has been found to be higher for those serving in the~     military than in the general population. There are approximately 4,200 Veterans with ALS and~     roughly 1,000 new cases each year. When doctors attempt to determine the degree to which an~     ALS patient is suffering from the disease, they apply tests that are graded by experts.~     However, this approach to testing patients may not be very accurate. Researchers aim to use a~     system called DESIPHER to listen to ALS patients and find speech mistakes related to their~     condition. Researchers believe that, by detecting different types of errors, DESIPHER serves~     as a new kind of indicator of medical problems such as difficulty breathing or swallowing,~     without human grading. This may also lead to a better system for automatically~     understanding ALS patients' speech.~   "
68139|NCT02675062|"~     The purpose of this study is to determine whether habitual physical activity and sedentary~     behaviour improve six weeks and between three to six months after total knee replacement~     surgery in people with osteoarthritis.~   "
68140|NCT02675049|"~     This trial is going to evaluate the safety and effectiveness of intranasal~     DEX(dexmedetomidine) in breast lumpectomy under local anaesthesia,and to investigate the~     optimal dose of intranasal DEX in breast lumpectomy.~   "
68141|NCT02675036|"~     The purpose of this study is to see whether extraction of the primary canine tooth or~     extraction of both the primary canine - and the primary first molar tooth is most effective~     in the treatment of palatally ectopic canine teeth in the maxilla. In addition the study will~     also measure pain and discomfort in relation to these two treatment alternatives.~   "
68142|NCT02675023|"~     This study will assess the pharmacokinetic (PK) and safety of a single 0.8 mL (40 mg)~     subcutaneous (SC) dose of M923 administered via an auto-injector (AI) or a prefilled syringe~     (PFS) in healthy subjects.~   "
68143|NCT02675010|"~     There are controversies about the best sites -biopsy based -tests for H pylori associated~     gastritis. The study is designed to evaluate the optimal site of gastric mucosal biopsy for~     identification of Helicobacter pylori, especially in case of gastric atrophy and/or~     intestinal metaplasia.~   "
68144|NCT02674997|"~     The purpose of this study is to investigate the feasibility and acceptability of the~     Standardized Goal Attainment Scaling menu for Hemophilia (GAS-Hem) as a patient reported~     outcome (PRO) measure to monitor clinical progress in participant-identified goal areas in~     individuals with hemophilia A.~   "
68145|NCT02674984|"~     This study will evaluate the safety and tolerability of combination probiotic BB-12 with LGG~     in healthy children with autism spectrum disorder aged 4-15 years. Subjects will be~     randomized to BB-12 with LGG orally (LGG dose: 10^9 c.f.u.'s; BB-12: 10^9) for a total of 56~     doses or placebo (maltodextrin) at 2:1 ratio. The time on study treatment is 56 days, and the~     target sample size is 30 individuals (i.e., 20 in the treatment arm and 10 in the placebo~     arm).~   "
68146|NCT02674971|"~     For weight loss to occur, energy intake needs to be reduced to incur an energy deficit. One~     dietary strategy that may facilitate reducing energy intake and enhancing weight loss is~     consuming a diet low in dietary energy density (ED). The ED of a given food, defined as the~     ratio of energy of the food to the weight of the food (kcal/g), is largely determined by~     water content, but is also affected by fat and fiber. Although the 2010 Dietary Guidelines~     encourage an eating pattern low in energy density (ED) to manage weight, it is currently not~     known what the best strategy is for reducing ED in the diet. Eating a greater number of foods~     low in ED or reducing the number of foods high in ED may reduce overall dietary ED. As ED is~     believed to reduce intake by allowing a greater weight of food relative to total energy~     consumed assisting with enhancing feelings of fullness, it is anticipated that either~     increasing consumption of low-ED foods in the diet alone or combining an increase in~     consumption of low-ED foods with a decrease in consumption of high-ED foods may be the best~     strategies for reducing overall dietary ED for weight loss.~   "
68147|NCT02674958|"~     Aspirin at doses used during acute myocardial infarction may inhibit the mobilization of~     endothelial progenitor cells (EPCs).~   "
68148|NCT02674945|"~     This project attempts to correlate wireless activity data with quality of life and sleep~     surveys in order to find a new method of monitoring patients during their treatment.~   "
68149|NCT02674932|"~     Research has shown that identifying and using one's character strengths in new ways decreases~     depressive symptoms and increases happiness in adults in the general population. Recently, we~     found that a similar intervention increases the self-esteem and self-efficacy of children and~     adolescents being treated in an inpatient psychiatric unit. The purpose of this study is to~     better understand the effects that discovering one's character strengths and incorporating~     them into coping skills will have on treatment outcomes in patients admitted to a child and~     adolescent inpatient psychiatric unit.~   "
68150|NCT02674919|"~     The purpose of the study is to investigate the efficacy of a 10-week intervention, using the~     Nordic Hamstring exercise, on repeated-sprint ability in male sub-elite football players. The~     primary outcome measure is total sprint time during 4x6 sprint of 10 meters measured using~     dual-beam photoelectric cells. Additionally, eccentric knee flexor strength is measured using~     the Nordbord hamstring strength measure. The hypothesis is that strength training of the knee~     flexor muscles elicited by the Nordic Hamstring exercise will result in enhanced repetitive~     sprint-ability expressed as a decrease in total sprint time. Furthermore, baseline data is~     used to assess to correlation between eccentric hamstring strength and active hamstring~     flexibility AND sprint performance.~   "
68151|NCT02674906|"~     The primary aim of this randomized controlled study is to determine whether the use~     Anticoagulant Citrate Dextrose Solution--Formula A (ACD-A) in cell salvage reduces~     inflammation and oxidative stress in cell saver blood compared to heparin. The secondary aim~     is to determine whether any differences in activation can be correlated to any differences in~     postoperative clinical outcome.~   "
68152|NCT02674893|"~     This is an open-label comparative study in three parallel groups. It is expected that 90~     patients and/or healthy volunteers will participate in this biomedical research.~      Distribution in groups~        -  30 patients with type 2 diabetes and an indication for treatment with a GLP1 analogue~          (group 1)~        -  30 patients with type 2 diabetes (control diabetic subjects) not treated with Incretins~          (group 2)~        -  30 healthy subjects (non-diabetics) (group 3)~      This study will investigate modifications in eating behaviour induced by Liraglutide in~     patients who start treatment with Victoza® and certain aspects, such as liking (hedonic~     characteristic of a food), wanting (desire to eat a given food) and salivation in response to~     the presentation of a food by taking measurements at D0 (before initiation of the treatment~     with Liraglutide in the group concerned) then at 15 days (except for the controls), 3 months~     and 9 months (only for controls).~   "
68153|NCT02674880|"~     The objective of this study is to test the effect of HMW-HA on NIV effectiveness in patients~     admitted to a sub-intensive care unit for respiratory failure due to acute exacerbation of~     COPD.~   "
68165|NCT02674724|"~     To investigate if resistance training exercises performed twice a week with or without gym~     equipment assistance in a 12-week period could improve balance in patients with Parkinson~     Disease (PD).~      Methods: Sixty three patients with idiopathic PD (Hoehn and Yahr stage II - III) and~     preserved cognitive function will participate in this study. Patients will be randomized~     among three intervention groups: resistance training with free weights, resistance training~     with gym equipment and control group. Investigators will use static platform balance~     variables to assess the primary end-point outcome measures. For the secondary outcomes~     measures, most common clinical functional balances tests for PD will be applied: Berg Balance~     Scale (BBS), Mini-BESTest - Balance Evaluation (Mini-BESTest), Timed Up and Go test (TUG) and~     variables from dynamic posturography.~   "
68154|NCT02674867|"~     The study aims to define and compare the immunological characteristics (lymphocyte~     subpopulations, specific immunity against HIV, lymphocyte activation, inflammatory~     parameters) and the virological characteristics (study of viral reservoir) between 2 groups~     of vertically-HIV-1-infected children, between 5 and 17-year-of-age, who started cART before~     6 months-of-age (early treatment group) or after 24 months-of-age (late treatment group)~     with an initial virologic success (HIV-1 RNA <400 copies / mL reached no later than 24 months~     after the start of cART), whatever the later evolution of the viremia.~      Moreover, the viral reservoir will be deeply characterized in 10 children (5 patients in each~     group) with sustained control of the HIV-1 viremia under cART (≥ 90% of HIV-1 RNA measures~     <400 copies /mL): quantification of the reservoir in the lymphocyte subpopulations and study~     of the inductibility of the viral reservoir.~   "
68155|NCT02674854|"~     To evaluate ocular hypotensive efficacy and safety of PG324 Ophthalmic Solution compared to~     netarsudil (AR-13324) ophthalmic solution 0.02% and latanoprost ophthalmic solution 0.005%~   "
68156|NCT02674841|"~     This study investigates if live feedback during home-based exercises will improve the ability~     to perform the exercises with the prescribed time under tension (TUT) per repetition compared~     with no feedback among adolescents with patellofemoral pain. The hypothesis is that~     adolescents who receive live feedback from BandCizer™ will have a mean TUT that is~     significantly closer to the prescribed TUT compared to the group not receiving feedback~     during the course of the intervention.~   "
68157|NCT02674828|"~     The purpose of this pilot study is to evaluate the initial efficacy of a reinforcement~     intervention to enhance physical activity levels in sedentary adolescents and young adults~     with type 1 diabetes (T1D). The intervention will reinforce patients for meeting physical~     activity goals, with escalating reinforcers provided when patients achieve continuous weeks~     of meeting goals. A 12-week trial will be conducted in which 60 patients will be randomized~     to: (1) standard care or (2) standard care plus reinforcement.~   "
68158|NCT02674815|"~     Colorectal and thoracic surgical patients are susceptible to poor postoperative outcome~     including complications, mortality and increased length of stay. Preoperative physical~     fitness is protective against poor postoperative outcome in intra-abdominal and thoracic~     surgery.~      The current colorectal/thoracic pathway from diagnosis to surgery is about 2 weeks and~     therefore interventions of longer duration are not feasible. Clinicians may be presented with~     a difficult choice in delaying surgery to perform prehab or cancel the pre-op intervention.~      To create greater improvements in aerobic fitness, participants are required to exercise at~     high levels of VO2peak (e.g. ≥80% VO2peak). High intensity interval training (HIIT) requires~     participants to exercise at high levels of VO2peak (≥80% VO2peak) for short periods (e.g. 15~     seconds) followed by a recovery (active or passive) and typically continue this pattern for~     30 minutes or until exhaustion.~      HIIT programmes are safe and a recent meta-analysis noted that HIIT produced a more~     pronounced incremental gain in participants' mean VO2peak when compared with continuous~     moderate intensity exercise (+1.78mL/kg/min, 95% CI: 0.45-3.11).~      HITT has not been investigated as a preoperative intervention to either optimize fitness~     prior to surgery or reduce post-surgical complications. Preoperative HIIT is an intense~     intervention which will require significant participant adherence. The safety, cost and~     clinical application of such a programme needs to be performed. This feasibility study aims~     to assess the ability of HIIT to improve aerobic fitness two weeks prior to surgery and~     determine its feasibility.~   "
68159|NCT02674802|"~     Helicobacter pylori is closely related with gastritis, peptic ulcer, gastric cancer and~     gastric MALT lymphoma, and it may participate in a variety of parenteral diseases. Infection~     rates of Helicobacter pylori is still high, so effectively eradication is necessary. At~     present, the eradication therapy has achieved very good curative effect. However, relapse~     after eradication is unoptimistic. This study has made an analysis for reinfection after~     eradication of Helicobacter pylori Infection include the retrospective and prospective~     studies, aims to explore the epidemiological data and related risk factors of Hp reinfection~     in China.~   "
68160|NCT02674789|"~     Ionized magnesium variation is measured during a normal day and again during a day with an~     exercise protocol of 90 minutes.~   "
68161|NCT02674776|"~     This study is a multi-center, double-blind, randomized, parallel controlled trial. Patients~     with acute gout will be enrolled and randomly allocated into 2 groups: HuZhen capsule~     treatment group and Placebo control group. Randomization codes were established by the~     biostatistician. Observe will be followed for 3 days (72 hours) after the onset. Change of~     VAS score from baseline, proportion of improvement with damp-heat retention, change in~     C-reactive protein (CRP) and erythrocyte sedimentation rate ( ESR) from baseline, change in~     white blood cell count in whole blood cell analysis from baseline, and the number of adverse~     events will be monitored and compared between each groups.~   "
68162|NCT02674763|"~     This is an open label, multicenter Phase 1 study to determine the MTD, dosing schedule and~     RP2D of IMGN779 when administered as mono-therapy to adult AML patients with CD33 -positive~     disease.~   "
68163|NCT02674750|"~     This is a Phase 2, open-label, multicenter trial designed to evaluate the efficacy and safety~     of CUDC-907 in subjects 18 years and older with Relapsed/Refractory (RR) MYC-altered Diffuse~     Large B-Cell Lymphoma (DLBCL).~   "
68164|NCT02674737|"~     To evaluate the efficacy and safety of appropriate postoperative sedation with~     dexmedetomidine for patients after gastrectomy. Prospective randomised controlled study was~     conducted from October 2015 and December 2015 among patients after gastrectomy. The~     investigators are going to enroll patients who received abdominal surgeries. One group~     receive sedative along with analgesic and the other group analgesic only for the other group~     on the first 24 hours after surgeries and follow up for 3 days.~   "
68166|NCT02674711|"~     The purpose of this project is to assess the impact of an educational video on the use of~     prescription opioid medication during a 6-month period following spine surgery. Subjects will~     be recruited from the pool of patients coming in for the pre-operative appointment prior to~     spine surgery. Patients that consent and enroll will be randomized to receive either a brief~     educational video at this appointment or usual care. Patients will be followed after surgery~     weekly for the first month, and then again at 6 months to determine their prescription opioid~     medication utilization patterns. Prescription data will also be pulled from electronic~     medical records.~   "
68167|NCT02674698|"~     Objectives: The purpose of this proposal is to evaluate the impact of the CNH Dashboard~     implementation on the quality of VA Purchased CNH care relative to other CNH facilities, and~     to evaluate the quality of Veteran-specific care in purchased CNH facilities by transition~     and safety outcome measures derived from Veteran-specific CMS data.~      Methods: The investigators will evaluate the effect of the CNH Dashboard release in a~     randomized, stepped-wedge dissemination. This dissemination design allows us to determine the~     impact of the CNH Dashboard on the quality of purchased CNH facility more systematically than~     a single phase roll-out. In each of the 4 steps, The investigators will release the CNH~     Dashboard to a randomly selected set of VISNs. Dashboard release will be accompanied by~     education.~      Findings: The CNH Dashboard has actionable information to leaders in GEC at the local,~     regional, and national levels.~      Impact: When completed, this program will improve the quality of care Veterans receive in VA~     purchased CNH programs as demonstrated by improved selection of CNH facilities and~     Veteran-specific measures.~   "
68168|NCT02674685|"~     Examine the safety and effectiveness of Vfend [voriconazole] for prophylaxix use under~     general clinical practices.~   "
68169|NCT02674672|"~     To establish the clinical safety and efficacy of the VenaTech® Retrievable Vena Cava Filter~   "
68170|NCT02674659|"~     This research will add resistance training to patients who undergo cardiac rehabilitation~     program after coronary bypass surgery, comparing the level of PCSK9 level on that group to~     another group who receives conventional rehabilitation program (only aerobic exercise)~   "
68171|NCT02674646|"~     The ROSETTA-trial will evaluate the effect of acupuncture as a complementary treatment~     parallel to radiation therapy in oncological patients. The trial is designed as a two-armed~     trial. Depending on the treatment study arm either verum- or Sham sham-acupuncture will be~     applied. Acupuncture is applied treatment bi-weekly during the first week of radiotherapy,~     thereafter weekly until the end of radiotherapy; the follow-up visits include clinical workup~     as well as questionnaires.~   "
68172|NCT02674633|"~     The purpose of this study is to evaluate the effects of videogame-like digital therapies on~     attentional functioning and symptoms in children diagnosed with ADHD.~   "
68173|NCT02674620|"~     A post-concussion syndrome (PCS) diagnosis has historically led to a recommendation of~     continued mental and physical rest to minimize symptoms. However, this conservative approach~     does not consider the pathophysiological mechanisms and neurological subsystem dysfunction~     which mediate persistent signs and symptoms. Recently, developing research is recommending~     targeted therapies for specific post-concussion disorders (physiologic, vestibulo-ocular and~     cervicogenic). The Buffalo Concussion Treadmill Test (BCTT) is a graded aerobic test that has~     emerged as safe, reliable, and effective in distinguishing between post-concussion syndrome~     sub-types, quantifying physiological recovery, and guiding return to play decision making. It~     has been proposed that the results of a BCTT can be used to prescribe progressively~     intensifying whole body aerobic exercise (such as walking or biking), maintained at a~     sub-symptom threshold, to improve autoregulatory function with the potential to improve PCS~     symptoms. Positive results with BCTT have now made it the standard of care at the University~     of Buffalo Concussion Clinic and Pan Am Clinic during the management of sport related~     concussions. Despite its increased use in patients with post-concussion syndrome there is~     currently no data on the use of exercise treatment in the early stages of concussion~     recovery.~   "
68174|NCT02674607|"~     The aim of this study is to evaluate the possible immunologic effects of spirulina in~     children with beta thalassemia.~   "
68175|NCT02674594|"~     The overall objective of this proposal is to execute a real-world database analysis to~     evaluate hospital readmissions among hospitalized nonvalvular atrial fibrillation (NVAF)~     patients in the U.S~      Primary objective: To determine the proportions of NVAF patients with bleeding-related~     hospital readmissions that occur within 30 days of the hospitalization of NVAF patients~     treated with the new oral anticoagulants (NOACs), dabigatran, rivaroxaban, apixaban or~     warfarin in the inpatient setting~      Secondary objectives:~        -  To determine the cost associated with bleeding-related hospital readmissions that occur~          within 30 days of the hospitalization of NVAF patients treated with dabigatran,~          rivaroxaban, apixaban or warfarin in the inpatient setting~        -  To determine the proportions of NVAF patients with all cause hospital readmissions and~          the associated costs that occur within 30 days of the hospitalization of NVAF patients~          treated with dabigatran, rivaroxaban, apixaban or warfarin in the inpatient setting.~   "
68176|NCT02674581|"~     An oral dose in healthy and renally impaired subjects to determine the drug effect for~     BMS-663068.~   "
68177|NCT02674568|"~     The purpose of this study is to determine the efficacy of rovalpituzumab tesirine as a~     third-line and later treatment for subjects with relapsed or refractory delta-like protein 3~     (DLL3) expressing small cell lung cancer (SCLC).~   "
68178|NCT02674555|"~     This is a study to investigate the absorption, metabolism and excretion of [14C] labeled~     ASP8273 in subjects with solid tumors harboring EGFR mutations (per local testing). This~     study consists of two parts (A and B).~   "
68179|NCT02674542|"~     Women who have experienced a stillbirth or neonatal death are at higher risk of repeated poor~     neonatal outcomes if they have short interpregnancy intervals. Understanding the attitudes~     surrounding future fertility and contraception in this population is critical to propose~     socially and culturally acceptable interventions to address an unmet need for family~     planning.~      Participants: Women who have experienced a stillbirth or early neonatal death will be~     recruited from the postnatal ward of Bwaila Maternity Hospital in Lilongwe, Malawi.~      Procedures (methods): This will be a qualitative study using 20 in-depth interviews and four~     focus group discussions of up to 10 women each.~   "
68180|NCT02674529|"~     The proposed work aims to examine the neural changes associated with fast-acting~     antidepressant treatments in order to develop imaging-based biomarkers of treatment response~     for depression.~   "
68181|NCT02674516|"~     This study investigates the relationship between prefrontal cortex activity and antisocial~     and aggressive behavior, and risk factors for such behavior. In the double-blind, randomized~     controlled trial, participants will undergo three sessions of anodal transcranial direct~     current stimulation of the dorsolateral prefrontal cortex or sham stimulation and complete~     survey and laboratory measures assessing antisocial behavior and risk factors. Heart rate and~     skin conductance will also be measured.~   "
68182|NCT02674503|"~     After hospitalization, many older adults experience more difficulty getting around in the~     community and performing one or more of their basic activities of daily living (ADLs) like~     bathing or dressing. The goals of this study are to test the effectiveness of a mobility~     intervention, compared to usual care, on change in mobility after hospitalization, to~     determine the impact on one-year outcomes such as nursing home placement and to identify~     which Veterans benefit the most from the intervention. Ultimately, the goal is to improve~     recovery after hospitalization and reduce disability in hospitalized Veterans.~   "
68183|NCT02674490|"~     The investigators will study the effects of transcranial direct current (tDCS) stimulation~     during language therapy for naming in individuals with aphasia in the acute and subacute post~     stroke period. Naming difficulties are a persistent and common symptom in aphasia after~     left-hemisphere (LH) stroke. Behavioral therapy (speech and language therapy; SALT) is the~     mainstay treatment for post stroke aphasia. Transcranial direct cortical stimulation (tDCS)~     is a promising adjunct to traditional SALT. tDCS is a safe, non-invasive, non-painful~     electrical stimulation of the brain which modulates cortical excitability by application of~     weak electrical currents in the form of direct current brain polarization. It is usually~     administered via saline-soaked surface sponge electrodes attached to the scalp and connected~     to a direct current stimulator with low intensities. Most studies are conducted in the~     chronic phase after stroke. Because neuroplasticity is greatest early after stroke, there is~     reason to believe tDCS might be most effective in the acute-subacute period. However, only~     two studies have evaluated tDCS paired with language therapy in group studies of acute to~     subacute aphasic stroke patients and only one of these was sham-controlled. Furthermore, no~     studies (of which we are aware) have combined tDCS with therapy to facilitate naming in post~     stroke aphasia, as shown to be effective in studies of chronic stroke. In this study, the~     investigators will evaluate whether tDCS combined with SALT improves naming in individuals~     with aphasia in the acute and subacute post stroke period, more than SALT alone in a~     randomized, double-blind, sham-controlled trial. The investigators will test the hypothesis~     that anodal tDCS (A-tDCS) over a targeted region and computer-delivered SALT is associated~     with greater gains in accuracy in naming pictures, compared to sham combined with the same~     computer-delivered SALT in post stroke aphasia.~   "
68184|NCT02674477|"~     This research is being done to study whether using an Internet-based program, called the~     Therapeutic Education System (TES), would be helpful for the treatment of substance use and~     other psychiatric problems.~   "
68185|NCT02674464|"~     The investigators refined research aim is to determine if a clinic-based collaborative care~     team, including a community health worker (CHW) to deliver community-based contextualized~     care, reduces disparities in blood pressure control rates, lowers cardiovascular disease~     (CVD) risk, and improves outcomes among patients with hypertension and other common comorbid~     conditions when compared to standard of care health system approaches to CVD risk management,~     including audit and feedback and staff and provider training.~      Collaborative care includes care coordination and care management; regular and proactive~     monitoring and treatment to target specific patient needs using validated clinical tools and~     rating scales; and regular systematic caseload reviews by the care team and consultation with~     experts for patients who do not show clinical improvement. A typical collaborative care team~     includes the primary care provider, nurse care manager or coordinator, and other members of~     the clinic staff involved in patient care.~      Intervention protocols are designed to address common comorbidities (diabetes,~     hyperlipidemia, depression and coronary heart disease), lifestyle factors (dietary intake,~     physical activity, and smoking) and medication adherence. The investigators intensive~     intervention treats the whole patient, driven by individual patient goals and priorities,~     as opposed to the standard of care, which typically focuses on individual conditions. This~     proposed study responds directly to patient desires to feel more equipped to be involved in~     their care and manage multiple conditions that contribute to CVD. The investigators have~     worked successfully in the past with a broad range of stakeholders, including community~     members, patients, providers, and payors, and will continue to engage them through the~     research and dissemination process.~   "
68186|NCT02674451|"~     Contrast-medium induced nephropathy (CIN) is a frequent and devastating complication of~     coronary angiography, occurring in 10-50% of cases. As would be expected, the incidence of~     CIN is much higher in patients with underlying renal dysfunction. Multiple trials have found~     CIN to be an independent predictor of prolonged hospitalization and both 30 day and 1 year~     mortality in patients with coronary artery disease. Intravenous contrast dye is felt to cause~     renal ischemia as the mechanism of injury. Unfortunately, despite the significant morbidity~     and mortality with CIN, there are few therapeutic interventions to reduce the risk with the~     exception of hydration and high dose statin therapy. Recently, remote ischemic~     preconditioning (RIPC), a process of inducing transient arm ischemia by inflating a blood~     pressure cuff to 200 mmHg for 3 repetitive 5 minute cycles, leads to a systemic~     cytoprotective response and ultimately reduces ischemic renal injury, myocardial injury, and~     even cerebral injury following coronary bypass grafting. While there is significant data~     supporting the role of RIPC in reducing systemic ischemic injury in surgical patients, there~     is only one small trial studying RIPC in patient's undergoing coronary angiography. The~     investigators hypothesize that RIPC will reduce the incidence of contrast-induced nephropathy~     in patients with baseline renal dysfunction undergoing coronary angiography for stable or~     unstable coronary artery disease.~   "
68187|NCT02674438|"~     Heart failure is a condition where the heart pump does not function normally causing the~     lungs to become congested. The primary symptom of heart failure is shortness of breath, and~     this often leads to patients visiting the emergency department for care. Decision-making in~     the emergency department is a high-stakes situation, where there is a need for decision~     support to guide clinicians to make better decisions about admission to hospital or discharge~     home. Many low-risk patients who could potentially be managed at home are admitted to~     hospital whereas some patients who are thought safe to discharge are actually high risk and~     will have adverse outcomes if they are discharged home from the emergency department.~      In this trial, the investigators will study a new strategy for heart failure care, comprised~     of a computer algorithm to help doctors make decisions in the emergency department about the~     risk of their patient. For low-risk patients who are discharged home from the emergency~     department or after a short hospital stay, patients will be referred to a rapid follow-up~     clinic where the heart specialist team will rapidly assess and treat patients.~   "
68199|NCT02674282|"~     Our purpose is to evaluate maximum oxygen uptake (VO2max) in ACL-injured professional soccer~     players and after a six-month period of post-operative rehabilitation, compared to a control~     group of healthy professional soccer players.~   "
68200|NCT02674269|"~     The study will investigate the safety and efficacy of UroGen's TC-3 Gel for sustained release~     of Botulinum Toxin A (BTX) in urinary bladder in patients with idiopathic overactive bladder.~   "
68248|NCT02673645|"~     This research aims to continue to study the effectiveness of a promising academic~     intervention (implemented by SAGA Innovations) that has previously been shown to~     significantly improve academic outcomes for disadvantaged youth. In addition, this study will~     begin to investigate the effects of scaling up this promising strategy by exploring variation~     in tutor effectiveness and the optimal instructor-student and student-student pairings for~     improving academic outcomes.~   "
68249|NCT02673632|"~     The investigator suggests that PCOS women with high AMH levels are resistant to ovarian~     stimulation and may need adjustment of the dose of gonadotrophin.~   "
68188|NCT02674425|"~     Conventional dark-adaptometers are unsuitable as a mass screening tool due to their high~     cost, lack of easy portability, need of trained staff and a totally dark room to be operated,~     arbitrary testing procedures, associated time waste in clinic and patient burden to mention a~     few. Consequently, dark adaptometers are not routinely used as clinical tools for retinal~     diagnosis and monitoring despite the inherent benefits over other visual electrophysiology~     equipment such as the ERG system, whose cost and features may often be surplus to~     optometrists' requirements.~      This trial will assess the dark-adaptometry testing performance of a novel light-emitting~     system by generating full dark-adaptation threshold functions in normal adult healthy~     volunteers.~      The novel system has been proposed to overcome the issues associated with current~     instrumentation; it is semi-automatic and easy to use without the need of any skilled~     operator.~      It is envisaged that this system could spread the practice of dark-adaptometry testing and~     its adoption by high-street optometrists. This will allow diagnosing a number of retinal~     pathologies more quickly and more reliably that, faced with an ageing population, represents~     a major asset to the Health Community and the NHS.~      This trial will involve 20 healthy volunteers, distributed in equal number in 2 groups of~     18-40 and 50-70 years old, respectively. Proven the good health and eye condition of the~     participants, one of their eyes will be randomly-allocated and undergo dark-adaptometry~     testing 3 times on separate days within 3 weeks.~      Testing will clarify whether by using the novel system it is possible to reproduce~     state-of-the-art threshold measurements as good or better than those produced by~     commercially-available dark-adaptometers. Threshold measurements in the elderly will be~     compared with literature data adjusted to exclude aged crystalline lens and pupillary miosis~     contributions. Data variability and system usability will be also assessed.~   "
68189|NCT02674412|"~     This study evaluates the utility of buspirone in patients who have a diagnosis of functional~     dysphagia. All participants will be randomized to receive either a placebo pill or buspirone.~     Subsequently, we will evaluate whether their swallowing is improved. Participants who were~     randomized to receive placebo will then receive buspirone and those who were receiving~     buspirone will receive placebo. We will again evaluate whether their swallowing improved.~   "
68190|NCT02674399|"~     This study is a double-blind, randomized, controlled study with two arms to evaluate~     JointStem as a treatment for subjects with osteoarthritis. Following a 2-week screening~     period, approximately 45 subjects will be randomly assigned into one of the following two~     arms in a 2:1 ratio (2 JointStem : 1 positive control). After the last subject completes~     6-month visit (Visit 6) and the data management team confirms all data have no issue, the~     database will be locked and the blinding will be open for the statistical analysis. Subjects~     will then be scheduled for 9-month and 12-month follow-up visits (Visits 7 and 8).~   "
68191|NCT02674386|"~     A4091064 is a multicenter, long-term observational study of subjects from tanezumab~     interventional studies (regardless of treatment group) who undergo a total knee, hip or~     shoulder replacement during participation in the study. The study is designed with a total~     duration of subject follow-up of 24 weeks after the total joint replacement surgery. There~     will be two methods of data collection utilized in this study: interview by site staff via~     the telephone and interactive web-response system (or paper if the subject has no access to~     the internet).~   "
68192|NCT02674373|"~     The evaluation of the chemotherapy efficacy for gastric cancer patients is usually evaluated~     by computer tomography scans with RECIST criteria that are performed every two months during~     the treatment. The management of treatment for gastric cancer needs the development of early~     biomarkers to evaluate the efficacy in order to avoid unnecessary toxicity in case of early~     chemotherapy resistance. In this prospective study, we will compare the monitoring of~     circulating tumor DNA with the results of CT scan according the RECIST criteria and the blood~     level of CEA and CA 19-9 tumor markers.~      Thus, the objective of this study is to identify a prognostic and/or predictive biomarker of~     tumor response according to the tumor DNA circulating assessment in gastric cancer treatment,~     in order (i) to avoid an unnecessary toxicity of an ineffective treatment that it would be~     continued uselessly, (ii) and to allow a early changing to an alternative chemotherapy~     regimen.~   "
68193|NCT02674360|"~     Cancer patients often report that they are not included in important treatment decisions.~     Numerous studies have shown that a training concerning Shared Decision Making (SDM) for~     physicians can improve this situation. This does not only lead to a better quality of the~     doctor-patient interaction, but may have a positive long term impact on treatment adherence,~     the psychological well-being and the coping abilities of the patients. However, previous~     experience regarding the implementation of SDM training programs show that it is difficult to~     recruit physicians for an external SDM group training due to the extensive workload of the~     physicians. In light of the available evidence on the effectiveness of SDM training and the~     low motivation by oncologists for traditional SDM group training, this study aims to develop~     and evaluate a brief SDM intervention. This intervention is disseminated in two different~     ways which both might be attractive for oncologists. On the one hand an individual~     face-to-face context-based SDM training is designed and conducted by a trainer at the~     workplace of the participating oncologists. On the other hand a web-based SDM online training~     is developed. Both SDM interventions are developed on the basis of an SDM manual evaluated in~     previous studies.~      This study therefore aims to examine the effectiveness of different disseminations strategies~     (individualized face-to-face context-based SDM individual training vs. web-based SDM online~     training) compared to a control group without any training. It will be analyzed which~     improvements in medical SDM competence can be accomplished by the different SDM trainings.~     Further the effects of the training on SDM knowledge, quality of the doctor-patient~     interaction and SDM self-efficacy expectation will be evaluated.~   "
68194|NCT02674347|"~     Study to evaluate the safety and tolerability of multiple escalating doses of intravenous~     (IV) Zidebactam in healthy adult human subjects.~   "
68195|NCT02674334|"~     The purpose of this study was to use Near Infrared Spectroscopy (NIRS) monitoring on~     participants undergoing shoulder surgery in the beach chair position (BCP) to determine~     cerebral desaturation events (CDE) and to further determine cognitive changes pre and post~     surgery using the Mini Mental State Exam.~   "
68196|NCT02674321|"~     The purpose of this study is to evaluate safety, tolerability and preliminary efficacy of~     SD-809 in the treatment of motor and phonic tics of Tourette Syndrome and to evaluate the~     pharmacokinetic of SD-809 and its metabolites.~   "
68197|NCT02674308|"~     The purpose of this study is to assess the long-term safety of vedolizumab versus other~     biologic agents in participants with Ulcerative Colitis (UC) or Crohn's Disease (CD).~   "
68198|NCT02674295|"~     The purpose of this study is to determine the metabolic disposition of radiolabeled~     esketamine administered by the oral and intravenous routes in healthy male participants.~   "
69409|NCT02658448|"~     The purpose of this study is to determine whether GTx-024 is safe and effective in the~     treatment of stress urinary incontinence in postmenopausal women.~   "
68201|NCT02674256|"~     Introduction and aim~      Stress is well known to affect visceral sensitivity in Human. The investigators speculate~     that visceral hypersensitivity plays an important role in symptom perception in~     gastro-esophageal reflux disease (GERD). The role of acute stress mimicked by corticotrophin~     releasing hormone (CRH) administration on esophageal sensitivity has not been studied. The~     investigators hypothesize that stress mediated through CRH-release increases esophageal~     sensitivity. A first step in the investigation of this hypothesis is to study whether~     administration of CRH has an influence on esophageal sensitivity in healthy volunteers (HV).~     Therefore, the aim of this study is to investigate the effect of CRH-administration on~     esophageal sensitivity in a group of HV.~      Methods~      The study will be performed in cross-over on 15 HV with no prior history of digestive~     disease. Esophageal sensitivity will be tested by multimodal stimulation on two sessions~     (placebo and CRH-administration), with an interval at least of one week. The two sessions~     will be scheduled by randomization for every subject. After blinded administration of CRH~     100µg or placebo IV, esophageal sensitivity will be assessed using a multimodal esophageal~     stimulation probe which allows thermal, mechanical, electrical and chemical stimulations of~     the esophagus. Esophageal sensitivity will be assessed using Visual Analogue Scale (VAS), the~     mood with specific questionnaires (Manikin Self assessment SAM, Profile of Mood Schedule~     (POMS, State Trait Anxiety Inventory (STAI)) and the cortisol with salivary samples.~      Statistical analysis~      Esophageal sensitivity for the different stimuli (heat, mechanical, electrical and chemical)~     will be compared between CRH and placebo conditions. To determine the stress-inducing~     capability of CRH-administration, the POMS questionnaire, STAI, Manikin self assessment and~     cortisol levels after the stress-protocol will be compared with the basal measurements.~      Perspectives~      If CRH-administration increases esophageal sensitivity, a stress model could be applied to~     investigate the influence of a real life stressor on esophageal sensitivity in healthy~     subjects. In a third part, a mast-cell stabilizing drug could be tested after administration~     of a stressor in order to investigate its role on esophageal sensitivity. In the future, this~     might be proposed to refractory GERD in a controlled randomized trial.~   "
68202|NCT02674243|"~     This is prospective randomized control trial study. The aim of this study is to evaluate the~     efficacy of Iodopovidone solution for pleurodesis in palliative malignant pleural effusion~     (MPE) patients comparing to Talc. All adult patients who diagnosed MPE by cytology regardless~     primary tumor between December 1, 2015 and November 29, 2016 at Maharaj Nakorn Chiang Mai~     Hospital, Chiang Mai University, Chiang Mai, Thailand will be enrolled in this study. The~     inform and consent will be applied in all patients before treatment. Patients will be~     randomized to two groups; Iodopovidone group (intervention group) and Talc group (control~     group)~   "
68203|NCT02674230|"~     This study aims to study the relationships between obesity, circadian rhythm, and aging. The~     investigators set up a prospective cohort registry for morbid obesity, obesity, and normal~     subjects with annual follow-up. The cohort aims to investigate the pathophysiological,~     molecular, genetic, and cellular aspects of the relationships between obesity, circadian~     deregulation, and impacts on aging. Clinical data, questionnaires, biological material, and~     molecular signatures will be collected and investigated.~   "
68204|NCT02674217|"~     Multiple sclerosis (MS) is a chronic, inflammatory, debilitating disease that causes~     destruction of central nervous system (CNS) myelin, with varying degrees of axonal damage. It~     mainly affects young adults and is twice as common in women as in men (1). Studies published~     from the 1990s brought animal models and theoretical considerations of hematopoietic stem~     cell transplantation (HSCT) being useful in the prevention and treatment of autoimmune~     diseases, with clinical responses in some patients, suggesting that high-dose chemotherapy~     followed by HSCT rescue could reset the immunological changes through the control of~     autoreactive clones, followed by immunological tolerance after immune reconstitution (2);~     this led to the conclusion that HSCT may be a viable therapeutic option for MS (1-6).~     Autologous HSCT have been done in patients with MS since 1996 and more than 700 HSCTs have~     been performed around the world (1-6). Most patients have been treated in small trials or in~     multicenter studies. In retrospective analyzes, a progression-free survival of more than five~     years after transplant has been observed, the neurological outcomes being considerably more~     favorable in patients with the relapsing-remitting type and/or those who showed an~     inflammatory pattern in magnetic resonance imaging (MRI) during the pre-transplant screening.~     Reports of good results, particularly in the aggressive forms of MS reinforce the~     effectiveness HSCT in MS patients with prominent inflammatory activity. The risk of~     transplant related mortality in HSCT for MS was conventionally considered very high but has~     declined since 2001 to 1.3% (2-6), this probably being the result of the changes in the~     conditioning regimens, thus reducing toxicity. Recent data, with more than 700 autologous~     transplants for MS in Europe, showed an overall survival of 92% in five years and a~     progression-free survival of 46%, the main cause of mortality and morbidity being the~     recurrence of the autoimmune disease (2-6). The consensus provides an indication of HSCT in~     patients with progressive MS unresponsive to conventional therapy and Expanded Disability~     Status Scale (EDSS) (1) between 3.0 and 6.0. The forms of the disease that might benefit from~     transplantation are: relapsing remitting, primary or secondary progressive, and the~     malignant form, provided there is evidence of inflammatory activity at the time of~     transplant indication.~   "
68205|NCT02674204|"~     The purpose of this study is to to examine the effects of atorvastatin, a type of statin, on~     changes to the heart among women undergoing breast cancer treatment. Atorvastatin may reduce~     or eliminate the harmful effects of chemotherapy treatment to the heart tissue of breast~     cancer patients.~   "
68206|NCT02674191|"~     Treating hyperdivergent malocclusion accompanied by open bite could be challenging and may be~     done by several methods as high pull headgear and posterior bite planes or surgically by~     maxillary impaction in adults. Nowadays it's the skeletal anchorage system (SAS) era as~     mini-screws and mini-plates ,hence we are aiming for absolute anchorage, and could minimize~     patient cooperation and the need for surgical treatment.~   "
68207|NCT02674178|"~     All women had normal uterine cavity determined by previous hysterosalpingography or~     hysteroscopy. Women with abnormally low Gn as hypothalamic hypogonadism , High LH as PCOS and~     women with abnormal endocrine functions as abnormal thyroid or adrenal functions were~     excluded. Any woman with ovarian cyst or azopermic male partner was also excluded.~      The patients were subjected to history taking, including age, duration, type and cause of~     infertility and medical history. Full examination including general and abdominal and vaginal~     examination was done followed by ultrasound evaluation for presence of 3 or more pre-antral~     follicles and exclusion of ovarian cysts.~      Basal day 3 hormonal evaluation for FSH, LH and E2 in a natural cycle was done. E2, FSH and~     LH levels were determined using Immulite system (Siemens Healthcare diagnostics,UK).The~     intra- and inter-assay coefficients of variation were 15% and 16% for E2, 4.8% and 26% for~     LH. FSH analytical sensitivity was 0.1 mIU/ml.~      All participants underwent long protocol. Daily SC injection of Triptorelin : Decapeptyl 0.1~     mg (Ferring, Switzerland) 0.1 mg started at day 21 of the cycle prior to stimulation cycle~     and continued till the day of hCG injection. Gn stimulation started after fulfilling~     stimulation start criteria of thin endometrium < 5 mm and low E2 < 50 and LH < 5IU/l [18]~     with either HMG(Menogon; Ferring, Switzerland) or rFSH (Gonal-f; Merck Serono, Germany) in a~     starting dose of 150-300 IU/day depending on patients age and previous gonadotropin response.~     then the dose was adjusted according to ovarian response monitored by serum E2 and ultrasound~     evaluation. All patients were followed up by Transvaginal ultrasound scan daily or on~     alternate days according to the ovarian response to treatment starting on treatment cycle day~     (6) for folliculometry and endometrial thickness and pattern.~      Triggering by HCG 10000 IU IM (Pregnyl, Organon, the Netherlands) when at least 2 follicles~     reached a mean diameter of 18 mm [18]~      Cycle cancellation was decided when transvaginal ultrasound scan on cycle day (9) revealed no~     adequate follicular growth (<3 mature follicles).~      Ovum pick-up (OPU) was done 34-36 hours after hCG injection under transvaginal ultrasound~     guide.~   "
68220|NCT02674009|"~     The primary purpose for this multi-center, non-interventional study is to evaluate the~     duration of response defined as duration from first documented response of complete response~     (CR) or partial response (PR) until disease progression (as determined by the treating~     physician) for participants with laBCC.~   "
68221|NCT02673996|"~     Objective: In this pilot study, we will test the hypothesis that patients with POTS (age~     18-60 years) will have a higher percentage of functional antibodies to adrenergic receptors~     compared with control subjects without POTS.~   "
68208|NCT02674165|"~     The Haitian American Responsible Teen (HART) afterschool program, a cultural adaptation of~     the BART curriculum, will provide an HIV/AIDS curriculum adapted to Haitian students that~     consists of eight sessions lasting approximately two hours each over a twelve- week period.~     The comparison group will receive a nutrition intervention during the same time period. The~     primary goals of the evaluation are to determine the effectiveness of the HART program on~     delaying initiation of sexual intercourse, reducing number of sexual partners, and increasing~     abstinent behavior and contraception use among those who were sexually experienced at~     baseline.~      Over a five semester period, the programs will be implemented in 7 or more schools in the~     greater Boston area, with offerings in the fall, the spring and summer, among approximately~     780 male and female Haitian students. The programs will recruit 9th & 10th grade Haitian~     students who will range in age from 13 to 19 years old. We will implement a randomized~     controlled trial in which each semester, students within schools will be stratified by gender~     and then randomly assigned to participate in the HART or the nutrition condition. Students~     will be recruited annually and enrolled until the summer of 2015. During the spring and~     summer of 2012, 120 youth will be randomly assigned to a treatment condition. During year~     three, 180 youth will be randomly assigned to condition each semester (360 youth total during~     Year 3). During year four, 180 youth will be randomly assigned in the first semester, and 120~     youth will be randomly assigned in the second semester (300 youth total during Year 4). The~     number of times student-level randomization will occur and the number of groups formed will~     vary depending on the size of the 9th and 10th grade Haitian population served in each~     school.~   "
68209|NCT02674152|"~     This is a Phase I, non-randomized, uncontrolled, open-label, dose escalating study of BI~     836880 administered intravenously. The eligible patient population will be patients with~     advanced solid tumours. At any time during the trial, it will not be permitted to escalate to~     a dose which does not fulfil the escalation with overdose control (EWOC) criterion~   "
68210|NCT02674139|"~     The study aims to compare immediate post-placental (within 10 minutes of placenta delivery)~     intrauterine contraceptive device (Copper T 380A) insertion versus conventional placement at~     6 weeks (often referred to as delayed or interval insertion) regarding the clinical outcomes~     (safety, efficacy, expulsion and continuation rates) for women undergoing caesarean section.~   "
68211|NCT02674126|"~     A newborn's recognition and preference for their mother's voice occurs early in life, very~     likely during fetal development. Maternal voice stimuli undergo a unique form of cerebral~     processing that lends support for the existence of neurophysiologic mechanisms that reflect a~     child's preference for his/her mother's voice. This study aims to evaluate and compare the~     effect t of maternal sound listening in children undergoing cardiac surgery on stress~     response and physiological parameters.~   "
68212|NCT02674113|"~     The purpose of this research is to determine differences in outcomes in patients who receive~     regional anesthesia (a fascia iliaca block) versus placebo prior to undergoing hip~     arthroscopy with labral repair and/or debridement and osteoplasty for hip impingement.~   "
68213|NCT02674100|"~     The purpose of this study is to create a registry to provide insight into treatment selection~     and treatment outcome of pancreatic IRE in order to develop an evidence base such that~     physicians can provide the best possible care to patients with pancreatic cancer requiring~     surgical interventions.~      The investigators seek a better understanding of the uses of ablation in the treatment of~     unresectable soft tissue pancreatic tumors and the limitations, concerns and complications~     that earlier users have.~   "
68214|NCT02674087|"~     The purpose of this survey is to collect data from intrauterine life until the age of 18 of~     children born in Haute Vienne.~      The interest to realize such survey is to find correlations and interactions that may exist~     between the events that occurred during intrauterine life and those that will occur after the~     birth of the child. The investigators will examine every aspect of these children's lives~     from the perspectives of health, social sciences and environmental health~      These are medical events (occurrence of disease, medication), but also socio-cultural for~     this child (living environment, exposure to possible contaminants, events in family history).~      This cohort aims to include 3000 children a year (whose parents consented to their~     inclusion), all born at Haute-Vienne.~   "
68215|NCT02674074|"~     Measurement of corneal temperature gives indirect information about the ocular blood flow.~     For this reason corneal temperature can be used as a surrogate to quantify ocular blood flow.~     It can be measured by means of infrared thermography. This test, however, is not used in an~     everyday clinical routine so far. In this study is investigated if ocular blood flow~     disturbances in glaucoma patients can be diagnosed by means of infrared thermography.~      Corneal temperature are measured in normal tension glaucoma patients and healthy controls~     before and after cold provocation test. In the group of patients and the group of controls,~     subjects with and without a primary vascular dysregulation (PVD) are included. This will~     allow to analyze and compare the influence of cold provocation on corneal temperature (and~     indirectly ocular blood flow) in these study Groups.~   "
68216|NCT02674061|"~     This study will assess the efficacy and safety of pembrolizumab (MK-3475) in women with~     advanced ovarian cancer who have demonstrated recurrent disease following the front line~     platinum-based treatment and debulking surgery and received up to 5 lines of treatment for~     recurrent ovarian cancer (ROC) per local standard of care. Participants will receive~     pembrolizumab every 3 weeks (Q3W) for up to 2 years.~   "
68217|NCT02674048|"~     Prospective non-interventional study conducted in Australia, Brazil, Mexico and Europe to~     evaluate clinical practice with Metvix Daylight PDT in the treatment of mild to moderate~     actinic keratosis of the face/scalp and to assess physician and patient satisfaction.~   "
68218|NCT02674035|"~     Thirty women with similar abdominal deformities, who had had at least one pregnancy, were~     randomized into three groups to undergo abdominoplasty. Plication of the anterior rectus~     sheath was performed in two layers with 2-0 monofilament nylon suture (control group) or in a~     single layer with either a continuous 2-0 monofilament nylon suture (group I) or using a~     continuous barbed suture (group II). Operative time was recorded. All patients underwent~     ultrasound examination preoperatively and at 3 weeks and 6 months postoperatively to monitor~     for diastasis recurrence. The force required to bring the anterior rectus sheath to the~     midline was measured at the supraumbilical and infraumbilical levels.~   "
68219|NCT02674022|"~     The purpose of this research study is to screen for metabolic abnormalities that are maternal~     risk factors for having a child with autism.~   "
68223|NCT02673970|"~     1. Screen and recruitment: patients will be screened based on their prior history and~          intention to initiate treatment with an immune checkpoint inhibitor.~        2. Study phase:~             -  Collection of baseline demographic data, prior disease history, nature of ICI~               therapy, outcome data of ICI therapy (treatment disposition, toxicity, tumor~               response and survival).~             -  Collection of blood samples will be performed every 3 to 4 weeks for the first year~               on ICI therapy and every 6 to 12 weeks thereafter until the end of ICI therapy,~               disease progression, death or loss to follow-up. Collection of blood samples will~               be aligned with the visits necessary for the administration of the ICI therapy.~             -  Collection of archival melanoma metastasis tissues will be performed on a~               continuous basis and be triggered by availability of such tissue following~               therapeutic resections of melanoma metastases.~        3. Follow-up phase~   "
68224|NCT02673957|"~     This study aims to analyze the way the human body responds to a temporary lack of oxygen, or~     ischaemia. Prospective participants will complete a health screen to confirm overall health /~     low cardiovascular risk profile.The participants will be required to have pneumatic blood~     pressure cuff inflation to 200mmHg on the upper arm for 5 minutes which will then be deflated~     for 5 minutes and then repeating the cycle of inflation and deflation a further 3 times.~     Blood tests from veins in the forearm would be taken before, during, and after this is done~     in order to compare results and establish any change in concentration of local and~     circulating compounds.~   "
68225|NCT02673944|"~     A comparative study will be conducted and the patient will undergo a conventional urodynamic~     study. In order to successfully determine if the Peritron+ is capturing vesical pressure~     measurements consistent with conventional urodynamics the two sources of Pves will be~     collected concurrently.~   "
68226|NCT02673931|"~     Patients undergoing open heart surgery are at risk of suffering damage to the heart, brain~     and kidneys.~      This study is designed as a 2-by-2 randomized clinical trial with the purpose of~     investigating the organ protective effects of the glucagon-like-peptide-1 (GLP-1) agonist~     Exenatide versus placebo and restrictive versus liberal oxygenation during weaning from~     cardio-pulmonary bypass.~   "
68227|NCT02673918|"~     The investigators have developed an online rehabilitation platform to guide women in their~     home-based upper-body exercises after breast cancer surgery. The platform includes~     rehabilitation videos that will guide the women in performing home-based early post-surgery~     upper-body rehabilitation tailored for each individual.~      The primary objective is to assess the feasibility and acceptability of a home-based~     rehabilitation program supported by a supplemental online platform for women after breast~     cancer surgery before conducting a larger pragmatic trial in the future. The feasibility of~     the platform will be tested in 11 municipalities in Denmark.~   "
68228|NCT02673905|"~     The purpose of this study is to investigate the efficacy of an engineered cartilage~     transplant (N-TEC) in comparison to a cell-activated matrix (N-CAM) for the treatment of~     articular cartilage lesions in the knee. The main innovations in this trial are the use of~     nasal chondrocytes and the implantation of a tissue in contrast to cells seeded on a matrix.~     The goals of the trial are to: (i) evaluate whether implantation of a more mature graft~     (tissue therapy) is beneficial for the quality and durability of the repair tissue and the~     clinical outcome, (ii)determine the potential of the mature graft to integrate with the~     adjacent cartilage and form hyaline repair tissue and (iii) assess the efficacy of each~     treatment in correlation to the characteristics of the defect (e.g. acute versus chronic~     setting).~   "
68229|NCT02673892|"~     Improving the patient experience has become a major focus of quality improvement efforts in~     Ontario and in health systems worldwide. However, our existing knowledge base is relatively~     under-developed, particularly in how patients experience care as they transition from one~     care setting to another and the relationship between patient experience and clinical~     outcomes. The Patient Oriented Discharge Summary (PODS) is a discharge instruction tool~     created by patients, caregivers, health-care providers and design experts. It provides a~     written template for providers to engage patients and caregivers when reviewing important~     instructions on medications, activity and diet restrictions, follow-up appointments and~     worrisome symptoms warranting emergency care following admission to hospital. The PODS also~     uses plain and simple wording, large fonts, pictograms, and includes white space for patients~     to take notes and provides the option for translation of major headings into the most common~     spoken languages. The PODS impact study will study the impact of using the PODS versus usual~     discharge instructions on patient experience and health outcomes in a provincial-wide~     randomized study across acute care and rehabilitation hospitals.~   "
68230|NCT02673879|"~     The Second Investigation of the Management of Pericarditis (IMPI-2) Trial will compare the~     effectiveness and safety of complete percutaneous pericardial drainage facilitated by~     intrapericardial alteplase (recombinant human tissue-type plasminogen activator) to~     conventional pericardiocentesis when indicated in 2176 patients with large pericardial~     effusion due to tuberculous and non-tuberculous pericarditis. An internal pilot study of 218~     patients will initially confirm the feasibility of conducting a large-scale multi-centre~     clinical trial of intrapericardial fibrinolysis in patients with large pericardial effusion,~     and also provide preliminary safety data, following a dose finding study of intrapericardial~     alteplase.~   "
68231|NCT02673866|"~     The hypothesis of this Phase 2 study is that at least 1 dose regimen of DS-1971a will~     demonstrate clinical superiority to placebo in managing pain associated with DPNP, and will~     be generally well tolerated.~   "
68232|NCT02673853|"~     This study aims to establish the incidence of residual paralysis in patients following~     administration of a mini- dose of atracurium (less than ED95 i.e. <0.23mg/kg or <15 mg in~     most patients) during supraglottic airway insertion and correlate it with the duration of~     time from drug administration to arrival at PACU. The secondary aim is to compare the~     incidence of residual paralysis in patients who receive full doses of atracurium (per body~     weight) with those who receive mini-doses.~   "
68301|NCT02672943|"~     In this three-year project, our research teams are going to consecutively explore these~     important clinical, drug and physical rehabilitation treatment effects, noradrenergic~     network, autonomic dysfunction and microRNA signalling data as well as the correlations~     between them in early Parkinson Disease (PD) patients. The investigators hypothesize that the~     explorations of the above insights are unique and can provide an important source data for~     Taiwanese Parkinson Disease (PD).~   "
68233|NCT02673840|"~     Rationale and Aims: Infection by dengue virus (DENV) causes major morbidity and mortality~     throughout the world. In 2012, an estimated 3.6 billion people live in areas at risk for DENV~     infection, including Singapore. The key pathology of DENV infection is vascular leakage,~     which can occur in mild cases and can become life-threatening in severe cases when patients~     may develop dengue hemorrhagic fever (DHF) or dengue shock syndrome (DSS). Mast cells (MCs)~     are strongly activated by DENV with preliminary studies showing that activation levels are~     correlated to disease severity in human patients. Thus, the investigators propose to use the~     MC stabilizing drug, ketotifen, to limit the immune pathology that is characteristic of~     dengue infection and treat dengue-induced vascular leakage. Methods: The ability of Ketotifen~     to reduce vascular leakage in DENV patients will be determined by assessing the pooling of~     fluid in the pleural cavity (measured by MRI and CXR) after 5 days of drug administration,~     evaluated as a percent change compared to baseline fluid levels. Additional measures of~     vascular leakage and immune pathology will be compared as secondary objectives. The trial~     will be conducted as a randomized, double-blind study comparing the responses of dengue~     patients given either ketotifen or placebo (n=55 per arm). Importance of proposed research:~     Currently, no targeted treatments exist to limit vascular leakage during DENV infection. If~     Ketotifen is identified as effective for preventing pleural effusion and/or plasma leakage in~     DENV patients, this would constitute an advance for the clinical management of DENV fever.~     This finding would also support a large-scale trial to determine whether Ketotifen can be~     used to prevent severe vascular leakage as occurs during DHF/DSS. Benefits/Risks: Ketotifen~     has a record of safety and tolerability in humans, regulatory approval, and widespread use.~     Side effects are generally mild. The potential exists that, if effective, many of the painful~     and life-threatening symptoms of DENV infection that result from plasma leakage would be~     improved.~   "
68234|NCT02673827|"~     Objective: Evaluate the effects of Progressive Muscle Relaxation on sleep quality and on~     stress and depression levels of individuals with multiple sclerosis.~   "
68235|NCT02673814|"~     The primary purpose of this research study is to see whether adding bavituximab (an~     investigational drug) to durvalumab will improve the results of the treatment for~     non-small-cell lung cancer.~   "
68236|NCT02673801|"~     The purpose of the study is to evaluate an algorithm to screen patients with suspected knee~     osteoarthritis referred to an orthopedic outpatient clinic by using radiographs and~     patient-reported symptoms. It will be investigated whether the algorithm is able to identify~     which patients that are deemed relevant to undergo an orthopedic assessment. This will be~     evaluated by estimating the sensitivity of the new algorithm compared to with the traditional~     clinical assessment of the patients.~   "
68237|NCT02673788|"~     This is a follow-up study of the open label, single-center, phase I clinical trial to~     evaluate the safety of Pneumostem® in premature infants with Intraventricular hemorrhage.~   "
68238|NCT02673775|"~     The purpose of the study is to better understand the mechanisms of lung injury from ozone~     exposure. Subjects will participate in two exposure sessions: filtered air and 0.2 ppm ozone.~     Subjects will be asked to produce sputum through coughing after each exposure. The samples~     will be analyzed for macrophage activity.~   "
68239|NCT02673762|"~     A PRoBE design study will be used to obtain saliva from patients before undergoing blood~     study evaluation for screening at risk patients for the presence of undiagnosed pre-diabetes~     of type II diabetes. Pre-specified saliva biomarkers will be evaluated along with~     multi-marker models for their discriminatory value for distinguishing patients with normal~     glucose metabolism from those with disease. Appropriate housekeeping genes will also be~     incorporated to allow for the measurement of relative gene expression.~   "
68240|NCT02673749|"~     RP-G28 is being investigated for treatment of moderate to severe lactose intolerance and its~     potential to improve the tolerance of lactose (dairy products).~   "
68241|NCT02673736|"~     The purpose of this research study is to evaluate safety, pharmacokinetics and preliminary~     efficacy of the investigational drug PLX73086 in subjects with solid tumors including~     subjects with locally advanced or refractory tenosynovial giant cell tumor (TGCT).~   "
68242|NCT02673723|"~     Mortality associated with difficult airway in anesthesia is up to 30%. So, it is urgent to~     find a safe and effective method for intubation. Awake tracheal intubation which is used to~     retain spontaneous breathing is one of the important measures to ensure the safety of the~     patients with difficult airway in anesthesia.~      Sufentanil is used to provide good analgesia and can effectively inhibit the reaction of~     awake tracheal intubation, however, the outstanding problem is serious respiratory depression~     after intravenous sufentanil injection. Few study showed that dezocine is a kappa opioid~     antagonist related to mild respiratory depression and can prevents sufentanil-induced cough~     during general anesthesia induction.It is necessary to carry out large-scale, multi-center,~     randomized, controlled clinical study to determine whether dezocine prevents~     sufentanil-induced respiratory depression and whether dezocine combined sufentanil is a safe~     and effective method for awake tracheal intubation.~   "
68243|NCT02673710|"~     The purpose of this study is to explore the relationship between sarcopenia, as defined by~     computed tomography, treatment related outcomes and other body composition related parameters~     in a patient population receiving bevacizumab beyond progression.~   "
68244|NCT02673697|"~     Prospective, randomized, stratified non blinded multi-center, international, post market~     trial assessed in a non-inferiority study.~      A minimum of 1234 subjects will be enrolled at approximately 60 worldwide investigational~     sites where the device is commercially available.~      The primary objective of this trial is to test the safety and efficacy of Perceval versus~     standard sutured stented bioprosthetic aortic valves among the intended trial population.~   "
68245|NCT02673684|"~     The purpose of this study is to evaluate the ability of Neuro-Stim System, a~     non-pharmacologic alternative for pain management, to reduce pain and treat insomnia.~     Neuro-Stim System uses electrical current to stimulate neurovascular bundles (nerves) in the~     ear and possibly the autonomic nervous system.~   "
68246|NCT02673671|"~     A feasibility study for assessing and recording myoelectric activity in patients for early~     detection of a post-operative ileus (POI) in patients who undergo gastrointestinal surgery~     and differentiating the myoelectric signals from those who have normal post-operative return~     of GI function.~   "
68247|NCT02673658|"~     The purpose of this longitudinal study is to examine the ongoing interaction between the~     domains of cognitive and motor development in infants with neuromotor disability, and to~     compare outcomes of two groups of infants receiving two different types of home-based,~     parent-delivered physical therapy intervention, in order to determine which intervention is~     more effective in advancing cognitive as well as motor development. Knowledge of the~     effectiveness of two types of intervention will lead to improved early intervention for~     children with developmental disabilities, as well as future studies to examine ongoing~     outcomes.~   "
68250|NCT02673619|"~     Umeclidinium (UMEC) is a potent pan-active long-acting muscarinic antagonist (LAMA). It is~     anticipated that topical administration of UMEC will block stimulation of muscarinic~     receptors, thereby reducing the overproduction of sweat in subjects who suffer from~     hyperhidrosis. This study will assess the clinical effect, pharmacokinetics, safety and~     tolerability of topically applied UMEC following once daily topical administration, for 28~     days, to the palms, in subjects with primary palmar hyperhidrosis. The study will also~     investigate if topically applied UMEC, at the highest possible concentration, will decrease~     palmar hyperhidrosis with a systemic anticholinergic adverse event profile similar to or~     below that observed with inhaled administration. This is a double blind (Sponsor unblind),~     repeat dose, randomized, parallel group, placebo controlled study. Study will enrol up to 55~     subjects.~   "
68251|NCT02673606|"~     The goal of this project is to examine how estrogen may influence the resting-state~     connectivity and the extinction-induced activation of the fear extinction network.~   "
68252|NCT02673593|"~     The purpose of the study is to investigate the safety, pharmacokinetics and food effect of~     DS102 (up to 2000mg single and multiple daily doses) and placebo in healthy participants.~      DS102 capsules will be orally administered for up to 4 weeks, and will be compared against~     placebo.~      The study will enrol approximately 56 adult subjects.~   "
68253|NCT02673580|"~     The aim of this study is to compare quality of care and patient experiences in two~     outpatients follow-up activities: 1) Standard telePRO (fixed interval telePRO follow-up) and~     2) Open Access telePRO (patient-initiated telePRO follow-up)~   "
68254|NCT02673567|"~     This is a single center, randomized, double-blind, placebo-controlled study to assess the~     pharmacokinetics, safety, and tolerability of subcutaneous administration of TEV-48125~     (single ascending doses and single doses up to 900 mg) in Japanese and Caucasian healthy~     subjects.~   "
68255|NCT02673554|"~     In patients with type 2 diabetes, the incretin hormone glucose-dependent insulinotropic~     polypeptide (GIP) has lost its insulinotropic activity, but more so after continuous versus~     bolus administration. The design was a two-way crossover design comparing repeated bolus~     injection and continuous infusion of GIP under hyperglycaemic clamp conditions. Patients were~     age- gender- and weight-matched with type 2 diabetes, first degree relatives of such~     patients, and healthy subjects. Investigators performed a:~        1. Oral glucose challenge;~        2. hyperglycemic clamp (8.5 mmol/l) with two repeated GIP bolus administrations (50 pmol/kg~          body weight at 30 and 120 min); and~        3. hyperglycemic clamp with continuous administration of GIP (2 pmol.kg-1.min-1 from 30-180~          min).~      To answer the question, whether rapid tachyphylaxis occurs with regard to the insulinotropic~     action of GIP, investigators studied type 2-diabetic patients, their first-degree relatives,~     and healthy controls under hyperglycaemic clamp conditions with two GIP bolus injections 90~     min apart, and compared this to a continued intravenous infusion of GIP.~   "
68256|NCT02673541|"~     The present study aims to compare the clinical efficacy and cost effectiveness of the AXIOS™~     stent versus the conventional approach using double pigtail plastic stents in the treatment~     of patients with walled-off pancreatic necrosis.~   "
68257|NCT02673528|"~     Acute appendicitis (AA), is a common intra-abdominal surgical pathology with the overall~     incidence of approximately 7% and mortality of 0.2-0.8%. Treatment of choice is the surgical~     removal of the inflamed appendix by using open or laparoscopic appendectomy.~      Following laparoscopic appendectomy (LA) proved to be a feasible and at least as safe as the~     corresponding open procedure, it has rapidly gained worldwide acceptance. The traditional~     approach to LA uses three ports. Over the past decade, successful attempts to perform the~     procedure with fewer ports have been reported.~      The authors' primary objectives were to 1) identify a simple, safe and feasible way to~     perform laparoscopic appendectomy in patients with uncomplicated acute appendicitis. 2)~     determine the health related quality of life of the patients and calculate the cost per~     quality adjusted life years (QALYs) gained after the procedures (LAA and TLA). 3) Purpose a~     surgical algorithm when approaching to acute appendicitis with the consideration of quality~     of health and cost.~   "
68258|NCT02673515|"~     InterFast is a Cohort study with an embedded randomized controlled pilot trial. Study~     participants will be healthy subjects and subjects who already practice Alternate Day~     Fasting. The trial will include 100 participants (50 Participants in Alternate Day Fasting~     group and 50 participants in the control group). Those participants in the control group will~     be asked to participate in a short randomized controlled trial, where they will be either~     allocated to an Alternative Day Fasting group or another control visit.~   "
68259|NCT02673502|"~     Enhanced Recovery after Surgery (ERAS) pathways include multiple evidence-based interventions~     delivered throughout the peri-operative period that aim to attenuate the surgical stress~     response and support rapid physiologic and functional recovery.A key element of the ERAS~     pathway is the administration of a clear carbohydrate-rich beverage 2-3 h before surgery in~     order to keep the patient in a fed state rather than a fasted state when they go to the~     operating room. The aim of the current study is to investigate the impact of a drink~     containing simple carbohydrate on attenuating surgical stress induced insulin resistance in~     patients undergoing major laparoscopic abdominal surgery, compared to drinks containing~     maltodextrin.~   "
68260|NCT02673489|"~     The purpose of this study is to determine whether 24 weeks of Daclatasvir and Sofosbuvir with~     Ribavirin is safe and effective in the treatment of genotype 3 hepatitis C infected patients~     with liver cirrhosis.~   "
68261|NCT02673476|"~     This study is being to see how effective and safe ALS-008176 is in treating adults in the~     hospital with a Respiratory Syncytial Virus-Related Illness.~   "
68262|NCT02673463|"~     This study aims to assess whether treatment with a drug called spironolactone, which is an~     aldosterone inhibitor, can improve ability to cope with exertion, quality of life and ability~     of the heart to relax better in symptomatic patients with atrial fibrillation with preserved~     pumping capacity.~   "
68263|NCT02673450|"~     This study investigates a possible relationship between disturbance of the cyclic expression~     of ten different clock genes and development of delirium in patients admitted to an intensive~     care unit~      It also investigates a possible relationship between disturbance of the cyclic expression of~     melatonin and development of delirium in patients admitted to an intensive care unit.~      Finally a possible relationship between genetic differences in the PER3 gene and development~     of delirium is investigated.~   "
68264|NCT02673437|"~     Rivaroxaban is a medicine which reduces the formation of blood clots. Acute coronary syndrome~     (ACS) comprises a range of disorders, including heart attack and unstable angina, caused by a~     sudden reduction in blood flow to part of the heart muscle. This study aims to collect~     information on the use of rivaroxaban and its safety when used by patients for the prevention~     of atherothrombotic (plaque rupture leading to a blood clot) events following ACS, during the~     first three months after starting. This study was requested by the European regulatory body~     (EMA) which is responsible for the use and safety of medicines. It will last for~     approximately 3 years and is a national study covering the whole of England and Wales. The~     study aims to recruit 1193 patients who have been prescribed rivaroxaban and antiplatelet~     therapy and 1193 patients who have been prescribed alternative dual antiplatelet therapy for~     the secondary prevention of atherothrombotic events following ACS. Each patient will only be~     monitored for the first 13 weeks after hospital admission for ACS. Patients who choose to~     take part will complete a consent form. The patient's care team will be asked to complete a~     baseline questionnaire about the patient at the time the medicine is given and a further~     questionnaire up to 16 weeks later, specifically asking about the patient's experiences~     whilst on the medication. If anything unusual is reported during the observation period, the~     care team may be asked to fill out a followup questionnaire. With the patient's consent, the~     study team will also inform the patient's General Practitioner (GP) of their participation in~     the study and will ask the GP to complete an abridged questionnaire from the patient's~     medical records. The study team will analyse and aggregate the data, carefully protecting~     patient confidentiality, to classify adverse events of interest, in particular bleeding~     events.~   "
68265|NCT02673424|"~     To compare the safety and efficacy of FFR (fractional flow reserve)-guided percutaneous~     coronary intervention (PCI) strategy with IVUS (intravascular ultrasound [IVUS])-guided PCI~     in patients with intermediate coronary stenosis.~   "
68266|NCT02673411|"~     The purpose of this study is to measure diagnostic performance of ultrasound shear wave~     elastography to detect advanced hepatic fibrosis.~   "
68267|NCT02673398|"~     This phase II trial studies the side effects of and how well neratinib works in treating~     older patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer~     that has spread from where it started to other places in the body (metastatic). Neratinib may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
68268|NCT02673385|"~     In France, the last national perinatal survey show that 6.6% of live births are premature.~     For these infants, transfer in Neonatology sector may result in mother-child separation can~     last several weeks or months. This hospital can complicate the implementation of the~     attachment process that allows parents to recognize their children as their own, to gain~     confidence in their abilities to deal with them and establish a relationship with him.~      A study of mothers of premature shows the interest of the Brazelton scale to help them~     identify the skills their child and adjust their own behavior.~   "
68269|NCT02673372|"~     This research project is geared towards geriatric analgesia in the Emergency Department (ED)~     with a goal of reducing the administration of opioid pain medications to elderly patients,~     thereby avoiding the commonly occurring, severe side effects associated with such~     medications, including hypotension, respiratory depression, altered mental status, delirium,~     as well as nausea/vomiting and constipation.~      The primary outcome of the study will be difference in pain score from baseline to 30 minutes~     post-medication administration. The secondary outcomes will be the need for rescue analgesia~     and the incidence of adverse side effects and patients' satisfaction with low-dose ketamine~     or low dose morphine analgesia in managing their painful conditions in the ED.~      This project has the potential to change and modify the ED approach to geriatric analgesia by~     virtue of minimizing the use of opioid administration in elderly patients. T~   "
68270|NCT02673359|"~     The aim of this study to compare vaginal progesterone supplementation to cervical cerclage~     for prevention of preterm labor in women with short cervical length and history of previous~     midtrimester miscarriage and/or preterm labor.~   "
68271|NCT02673346|"~     The aims of this study are 1) To assess the prevalence of tobacco use and cessation treatment~     preferences among YKHC employees, 2) To assess employee's current levels of perceived stress,~     engagement in physical activity, and feelings of resiliency to inform future tobacco~     cessation interventions, and to examine the relationship between these factors and tobacco~     use, and 3) To assess YKHC employees' perceptions and opinions of the hospital's current~     workplace tobacco policy and expansion of these regulations to all YKHC properties.~   "
68272|NCT02673333|"~     Pembrolizumab is a type of immunotherapy, and the purpose of this study is to find out what~     effects, good and/or bad, pembrolizumab has on you, and your cancer.~   "
68273|NCT02673320|"~     The studied pathology concerns post traumatic cervical spinal cord contusion on narrow spinal~     canal.~      The pathophysiology remains controversial. This pathology does not enjoy consensus support.~     Many questions remain regarding the surgical care and its delay.~      The purpose of the study was to demonstrate non-inferiority of early surgical treatment~     compared to the same surgery performed with a delay among patients identified as having a~     cervical spinal cord contusion on posttraumatic narrowed cervical canal.~      In the current state of knowledge and practices, the treatment of post traumatic spinal cord~     contusions on narrow spinal canal spinal decompression is performed remote diagnosis. The~     generally accepted delay is 15 days.~      The surgical technique is a conventional cervical spinal decompression surgery. The type of~     decompression (anterior or posterior) is dependent on the compression and therefore the~     clinical radiological analysis. The choice of the technique and the surgical approach are~     therefore left to the discretion of the surgeon.~      After completion of the clinical and radiological diagnosis of post-traumatic spinal cord~     contusion on narrow spinal canal, the patient was hospitalized in intensive care or in the~     Neurosurgery Service of the University Hospital concerned.~      After anesthetic consultation determining the feasibility or not of surgery and in the~     absence of other vital injury or involving life-threatening, early surgery within 48 hours of~     diagnosis is then considered (according to the assigned group).~      The surgical technique is a conventional cervical spinal decompression surgery. Way posterior~     surgery, laminectomy for spinal stenosis significant if greater than or equal to 3 floors~     will be preferred. In other cases, the type of surgery will be at the discretion of the~     surgeon and the opinion of the Staff Neurosurgery.~      The surgical procedure is identical in the two groups. Alone, the delay of the surgery varies~     : less than 48 hours for the first group and 15 days for the second.~      During the different monitoring visits (D0 (surgery), D7, M3, Y1 and Y2), the following~     criteria will be assessed : the quality and quickness of the motor and sensory recovery, the~     early post-operative evolution and the long and medium term evolution but also disability and~     functional sequelaes.~   "
68274|NCT02673307|"~     The aims of this prospective cross over study was to compare the gastric emptying of 250 ml~     water in fasting volunteers, in two situations : without chewing gum or while chewing gum~     during 45 min~   "
68285|NCT02673151|"~     This trial studies how well gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx)-HBED-CC~     (68Ga-PSMA) positron emission tomography (PET)/computed tomography (CT) works in detecting~     prostate cancer that may have come back in patients with elevated prostate-specific antigen~     (PSA) after initial treatment. A rise in blood level of PSA, a protein made by the prostate,~     after treatment with surgery or radiation in patients without symptoms indicates that the~     cancer may have come back (recurrence). PSA however cannot determine whether the disease is~     located only in the prostate or other places in the body. 68Ga-PSMA is a radioactive tracer~     that targets and specifically binds to tumor cells expressing PSA making them lighting up.~     PET and CT make computerizing pictures of areas inside the body where the radioactive~     substance is lighting up. 68Ga-PSMA PET/CT may be able to see smaller tumors than standard~     imaging and may help determine whether prostate cancer has come back and where it is in the~     body.~   "
68275|NCT02673294|"~     The level of stroke chronicity has been proposed as an influential variable related to~     functional balance. However, little is known about the effect of this variable on the~     effectiveness and maintenance of gains of physical therapy interventions on balance. The~     objective of this study is to determine the influence of time since injury on the~     rehabilitation of balance after stroke. Participants will be assigned to a least (6-12~     months), a moderate (12-24 months), or a most chronic (> 24 months) group. All the~     participants will train for 20 one-hour sessions, administered three to five times a week,~     combining conventional physical therapy exercises and customized exercises interfaced on a~     balance board that promotes the training of the ankle and hip strategies. Participants will~     be assessed before, after the intervention, and one month later with a posturography test~     (sway speed and limits of stability) and clinical scales (Berg Balance Scale, Functional~     Reaches Test, 30-Second Sit-to-Stand Test, Timed Up and Down Stairs Test, Stepping Test,~     Timed Up-and-Go Test, and the 10-meter Walking Test).~   "
68276|NCT02673281|"~     The purposes of the study are:~        -  Study Aim 1. To assess the mechanisms underlying the biological effects of short-term~          walnut consumption on appetite with functional magnetic resonance imaging (fMRI) and~          assessing neurocognitive function/memory~        -  Study Aim 2. To investigate the effects of walnut consumption (48g per day over 5 days)~          on appetite and satiety by analyzing molecules which regulate energy homeostasis such as~          adipokines, as well as resting metabolic rate which measures energy expenditure.~        -  Study Aim 3. To investigate the effects of walnuts (48g per day over 5 days) on insulin~          resistance, lipids, and inflammatory markers in obesity as well as the effect of walnuts~          when consumed as part of a mixed meal, on glucose excursions, insulin secretion and the~          excretion of gut peptides and free fatty acids.~   "
68277|NCT02673268|"~     The objective of this study is to demonstrate the feasibility of a mastectomy with~     conservation of the areola using axillary way only with the Da Vinci Robot Xi and immediate~     breast reconstruction using prosthesis.~      The interest is to avoid scars on the breast. The scars are limited to the armpit and under~     the arm.~      The aim is also to study the rate of complications, cosmetic results and quality of life.~   "
68278|NCT02673255|"~     Many plasma donation centers have Tetanus immunization programs that are implemented in order~     to collect plasma with high levels of tetanus antibodies. The immunization program requires~     participants to receive multiple tetanus vaccinations over a period of time with the goal of~     hyper-immunizing them to tetanus. Their antibody-rich plasma is then used to manufacture a~     tetanus immunoglobulin product which helps with the prophylaxis and treatment of tetanus~     disease.~      The Tetanus vaccine previously used for these programs is no longer being manufactured.~     Therefore, we must evaluate the safety and efficacy of a different vaccine when used for this~     purpose. The only other FDA approved Tetanus vaccines currently available for adults in the~     US are combination vaccines that also immunize against Diphtheria and/or Pertussis.~      In this study, the investigators will evaluate two vaccines that are combinations of Tetanus~     and Diphtheria (Td). Investigators will not evaluate any vaccines containing Pertussis~     antigen. The vaccines to be evaluated are manufactured by MassBiologics and Sanofi Pasteur~     (Tenivac).~      The package insert for these vaccines indicates they should be administered to previously~     vaccinated people once every 10 years. However, this study will evaluate whether they are~     safe and effective for dosing every 90 days.~      The investigators hypothesize that at least 25% of study subjects will have a positive~     response to at least one of the five planned doses. Each vaccine will be evaluated~     separately.~   "
68279|NCT02673242|"~     This study is a randomized controlled trial with the aim of evaluating the effect of~     homebased inspiratory muscle training (IMT) for patients with COPD in Norway. The~     intervention group will train with threshold IMT for 6 weeks. The control group will not~     participate in any other training method or sham. Evaluation parameters are maximal~     inspiratory pressure, six minute walk test, COPD assessment test, modified Medical research~     council dyspnea scale and spirometry.~   "
68280|NCT02673229|"~     By doing this study, researchers hope to learn if applying Santyl to the burn during the~     healing process affects the appearance of the resulting scar.~   "
68281|NCT02673216|"~     Miscarriage (spontaneous abortion, stillbirth, and preterm birth) is the most common adverse~     out-come of pregnancy and a significant proportion is caused by infection. The investigators~     aim to study vaginal specimens from 1200 pregnant women recruited before 14 weeks of~     gestation with follow-up at mid-term (week 19) as well as 300 women aborting spontaneously.~     Adverse pregnancy outcome will be correlated to the presence of bacterial vaginosis (BV)~     subclasses, to vaginal fluid inflammation markers, and to the presence of novel~     Chlamydia-like bacteria, in particular Waddlia chondrophila. Species specific quantitative~     PCR assays for BV-related bacteria as well as next-generation-sequencing will be applied on~     selected specimens with the aim to identify markers allowing for a personalised treatment~     approach.~   "
68282|NCT02673203|"~     To investigate whether the daily glucose profiles as assessed by continuous glucose~     monitoring for 1 week of normal weight, obese, and diabetic individuals relate to hunger~     levels and food intake.~   "
68283|NCT02673177|"~     This study compared robot-assisted total mesorectal excision (RTME) and laparoscopic total~     mesorectal excision (LTME) with regard to urinary function, sexual function and sphincter-~     preservation outcomes for low rectal cancer.~   "
68284|NCT02673164|"~     The aim of the SCIENCE study is, in an international multicentre double-blind~     placebo-controlled study, to investigate efficacy of direct intra-myocardial injection of 100~     mio. allogeneic Cardiology Stem Cell Centre_adipose derived stem cells (CSCC_ASCs) in~     patients with reduced left ventricular Ejection Fraction (EF) (≤45%) and heart failure.~   "
68286|NCT02673138|"~     This study will be an open-label, cross-over study as subjects will be studied under both~     study conditions - suspension of subcutaneous insulin infusion via pump during treatment with~     insulin alone (control) vs. suspension of subcutaneous insulin via pump during treatment with~     insulin and canagliflozin.~   "
68321|NCT02672683|"~     The purpose of this study is to evaluate the level of expression of 4 circulating microRNAs~     in the serum using RT-PCR. A pilote study with cardiac transplant patients has shown that~     expression of these microRNAs could discriminate patients with a histologically proven~     rejection from patient displaying a normal endomyocardial biopsy. The signature must be~     confirmed in unselected patients and its stability evaluated according to clinical,~     biological and immunological parameters of included patients.~   "
68287|NCT02673125|"~     Chromosomal abnormalities are a major cause of pregnancy loss. Preimplantation Genetic~     Screening (PGS) using Next Generation Sequencing (NGS) allows the effective detection of~     these abnormalities and improves clinical outcomes. However even the transfer of a~     chromosomally normal embryo does not guarantee successful implantation. Recent research by~     Fragouli, et. al. 2015 has demonstrated a strong association between mitochondrial DNA~     quantities (also known as MitoGradeTM) and implantation outcomes in embryos that are already~     classified by PGS as chromosomally normal. Investigators have also demonstrated in a clinical~     study that MitoGradeTM normal and PGS normal embryos have higher chances of implantation than~     MitoGrade elevated PGS normal embryos. Transferring MitoGrade elevated PGS normal embryos~     results in less than 10% implantation rates while MitoGrade normal PGS normal embryos~     resulted in more than 65% implantation rates. The risk of miscarriage after replacing either~     type is very low (about 8%).~      In order to understand the complete effectiveness of the test, investigators are conducting a~     paired prospective study. This means that investigators will be transferring a MitoGrade~     normal and a MitoGrade elevated embryo at the same time to see if one implants better than~     the other. It is expected that patients joining this study will benefit from knowing that at~     least one embryo is MitoGrade normal PGS normal.~   "
68288|NCT02673112|"~     To compare the efficacy of a sub-threshold aerobic exercise intervention provided with mobile~     health coaching (STEP-mhc) and a light stretching program (LS) to LS alone for 11-18 yo youth~     with persistent concussion symptoms.~   "
68289|NCT02673099|"~     Introduction: Patients with end stage renal disease are exposed to metabolic and hemodynamic~     complications due to the disease itself and as a result of the dialysis treatment related~     complications. Uremic toxins due to their middle molecular weight are not effectively removed~     during Hemodialysis. Their accumulation leads to chronic oxidative stress and chronic~     inflammation state associated with increased morbidity and mortality. In addition, during~     each dialysis session oxidative stress (OS) and inflammation are provoked once blood~     interacts with the dialyzer.~      In recent years the use of Online Hemodiafiltration (OL- HDF) has entered in order to enable~     better uremic toxins clearance. This a relatively new method of therapy that allows a larger~     volume of blood filtration during a single dialysis therapy compared with standard~     hemodialysis. It combines diffusion with convection to clear middle molecular weight~     substances more effectively compared with Hemodialysis. This method was found to reduce rates~     of cardiovascular morbidity and mortality among dialysis patients.~   "
68290|NCT02673086|"~     The primary aim of this study is to compare needle tip visibility between the coracoid~     approach and retroclavicular approach for infraclavicular brachial plexus block in patients~     undergoing elective upper limb surgery. Secondary aim is to investigate the differences~     between the two groups in the needle shaft visibility, sensorial block success rate, block~     performance time, block performance related pain, motor block success rate, surgical success~     rate, complications, patient satisfaction, use of supplemental local anesthetic, use of~     analgesic.~   "
68291|NCT02673073|"~     Before a HF patient gets maximally decompensated and visit emergency department, most~     patients experience symptoms and signs of on-going decompensation (or pre-decompensation),~     which may not be noticed by the patients. If HF patients were aware of symptoms and signs of~     ADHF and received early intervention to stop the process of on-going decompensation (or~     pre-decompensation), it would be possible to reduce the rate of hospitalization for ADHF or~     death. Thus, self-awareness and self-examination of heart failure symptoms, signs and medical~     compliance using a patient diary in HF management may improve the outcomes in chronic stable~     HF patients. A patient diary with 6 parameters can serve this purpose: body weight, blood~     pressure, heart rate, drug compliance expressed as number of remaining pills of previous day,~     edema grade, and dyspnea grade.~   "
68292|NCT02673060|"~     This study evaluates MBC-11 (a conjugate of a bone-targeting vehicle (etidronate) and a~     cytostatic agent [ara-C] in patients with malignant tumors with CIBD. This is a first use in~     human.~   "
68293|NCT02673047|"~     This study will describe the prescription conditions of botulinum toxin Type A (Botox®)~     injection for the treatment of urinary incontinence due to neurogenic detrusor overactivity~     (NDO) or idiopathic overactive bladder (IOAB) as per standard of care in clinical practice in~     France.~   "
68294|NCT02673034|"~     The aim of the study is to investigate the circadian variation in serum-progesterone in women~     undergoing controlled ovarian stimulation.~   "
68295|NCT02673021|"~     Does lung ablation improve clinical outcomes for patients deemed to be surgically high-risk?~   "
68296|NCT02673008|"~     Allogeneic hematopoietic cell transplantation (Allo-HSCT) is an effective therapy for acute~     leukemia, but relapse remains an important problem. Therapy options for relapse include~     stopping immune suppression, re-induction of chemotherapy, donor lymphocyte infusion (DLI),~     and another transplantation used alone or in combination. However, the efficacy of these~     interventions is limited. One approach to the relapse problem is to intervene before~     hematologic or pathologic relapse occurs based on minimal residual disease (MRD). In this~     study, the efficacy of MRD-directed DLI on transplantation outcomes will be evaluated in~     patients with acute leukemia receiving allo-HSCT.~   "
68297|NCT02672995|"~     The investigators propose a new treatment strategy of fractionated stereotactic radiosurgery~     with concurrent bevacizumab for brain metastases. This phase I dose-escalation study is to~     establish the feasibility of this strategy and find the recommended doses.~   "
68298|NCT02672982|"~     The overall objective of the research is to assess the long-term and cost-effectiveness of a~     combined nutrition psychosocial intervention to a stand-alone nutritional treatment of~     children with Severe Acute Malnutrition (SAM) aged 6 to 24 months in the Saptari District of~     Nepal.~   "
68299|NCT02672969|"~     This study aims to evaluate the pre-post smoke evacuation uses on surgical smoke and~     bio-aerosols particles in operating rooms at a university hospital, Thailand.~   "
68300|NCT02672956|"~     Investigators selected participants who operated by laparoscopic technique due to any~     gynecologic indication according to random number table. The ten mm trocar was inserted~     supraumbilical, infraumbilical and intraumbilical. The verres needle was not used in all of~     patients. One month after we evaluated umbilical scar by used vancouver scar scale and~     compared results of vancouver scar scale.~   "
88281|NCT02411578|"~     The purpose of this study is to determine if a small dose of glucagon (mini-dose glucagon) is~     effective for the treatment of non-severe hypoglycemia in adults with type 1 diabetes (T1D).~   "
68302|NCT02672930|"~     Hyperkalemia is a common problem in the emergency services and one of the life threatening~     metabolic emergencies. Calcium, insulin, beta adrenoceptor agonists, bicarbonate, diuretics,~     sodium polystyrene sulfonate and lastly dialysis are advised in treatment. Especially,~     avoiding evolution of serious arrythmias and iv calcium using in the treatment of occured~     electrocardiogram (ECG) abnormalities, there is not sufficient level of survey in the~     literature. So the aim of this study was to evaluate administration of iv calcium efficiency~     on vital signs and ECG.~   "
68303|NCT02672917|"~     Phase I Safety and Tolerability Study in Subjects with Pancreatic Cancer or Other CA19-9~     Positive Malignancies.~   "
68304|NCT02672904|"~     comparison results of treatment of early stage glottic cancer between two methods of surgical~     treatment - CO2 laser and KTP laser~   "
68305|NCT02672891|"~     Intrauterine balloon tamponade in the management of postpartum hemorrhage in the obstetrics~     emergency ward in menoufiya university hospitals as a low resource setting.Guidelines for the~     management of postpartum hemorrhage involve a stepwise approach including the exclusion of~     retained products and genital tract trauma. Uterine atony, which is the most common cause, is~     dealt with uterine rubbing and various uterotonic agents. Among the new modalities introduced~     to arrest the bleeding is the uterine tamponade using various balloons and catheters. The~     condom catheter uses a sterile rubber catheter fitted with a condom for uterine tamponade .~   "
68306|NCT02672878|"~     Treatment of patients with in-stent restenosis (ISR) remains a challenge. This study will~     assess the efficacy of Bioresorbable Vascular Scaffolds (BVS) (Abbott Vascular) in the~     treatment of patients suffering from ISR.~   "
68307|NCT02672865|"~     The purpose of this study is to determine safety and feasibility of adjuvant hyperthermic~     intraperitoneal chemotherapy (HIPEC) with mitomycin and cisplatin in patients with locally~     advanced gastric cancer undergoing standard surgical resection. Patients will be treated with~     HIPEC using a single dose of mitomycin 15mg/m2 and cisplatin 50mg/m2 at 41-42 C for 90~     minutes, during the definitive surgical resection for gastric cancer. HIPEC will be performed~     after resection but before anastomosis.~   "
68308|NCT02672852|"~     This is a confirmatory, multicentre, randomized, double-blind, placebo controlled, 104 week~     study with a 88 week treatment period and a 16 week follow-up period evaluating the efficacy~     and safety of BI 655066 / ABBV-066 (risankizumab) to support Registration for the treatment~     of moderate to severe chronic plaque psoriasis in adult patients. This study will also look~     at the maintenance of response following randomly withdrawing treatment from those patients~     responding to treatment at week 28, as well as the response to re-treatment for patients who~     relapse. This study will also assess PK and emergence of anti-drug antibodies as well as the~     influence of study treatment on disease specific markers. In a subset of psoriasis patients~     with concomitant psoriatic arthritis, the signs and symptoms of psoriatic arthritis will be~     evaluated to assess improvement.~   "
68309|NCT02672839|"~     The purpose of this study is to compare relative oral bioavailability of a capsule~     formulation of LGD-6972 to a solution formulation of LGD-6972.~   "
68310|NCT02672826|"~     The endothelium is a key barrier between blood and tissue compartments. It is a major target~     of factors involved in metabolic and cardiovascular pathologies. However, the study of native~     human adult endothelial cells is difficult due to the lack of appropriate models and~     thereafter the endothelium is actually not easily accessible for clinical investigation.~     However, our results recently showed that the endothelium from human adipose tissue exhibit~     distinct phenotypes, including endothelial cell number and inflammatory, angiogenic and~     senescent state, according to adipose tissue location, i.e. subcutaneous and visceral. It is~     well recognized that estrogens favour gluteo-femoral adipose tissue deposit and their deficit~     after menopause is associated with increased abdominal and visceral fat mass as well as~     metabolic dysfunctions. These perturbations might be prevented with hormonal therapy.~     However, no data are available concerning the endothelial cells from gluteo-femoral and~     abdominal adipose tissues in women.~   "
68311|NCT02672813|"~     The primary objective of this study is to access the effect of Pectoral nerve I and II blocks~     in breast surgery as measured by consumption of postoperative morphine or its equivalent.~   "
68312|NCT02672800|"~     The purpose of this study is to evaluate the feasibility and acceptability of a writing~     intervention (Reclaiming Yourself), intended to facilitate bereavement for spousal caregivers~     whose partners died with dementia.~   "
68313|NCT02672787|"~     Despite great strides, hypertension remains an incredibly important disease and public health~     problem. This study addresses this critical need among ED patients, a unique population of~     patients who are (a) likely to benefit from an antihypertensive adherence intervention due to~     their high prevalence of uncontrolled blood pressure and poor adherence, and (b) at high risk~     for poor cardiovascular outcomes. The protocol provides for a multicomponent intervention~     bundle to be tested among ED patients. Successful clinic-based behavioral interventions~     generally target a combination of barriers to adherence; bundled interventions have shown~     success in a wide range of settings and diseases. In some cases, bundled components were~     necessary to achieve blood pressure benefit in a primary care setting; isolated educational~     efforts have had mixed success in the ED.~   "
68331|NCT02672553|"~     The study purpose is to compare the EDWARDS INTUITY valve system in a minimal invasive~     surgical approach (MIS) with any commercially available aortic bioprosthesis in standard full~     ster-notomy surgical approach.~   "
68332|NCT02672540|"~     Safety and effect of SANGUINATE on Sickle Cell Disease patients experiencing a vaso-occlusive~     crisis who are admitted to the hospital for treatment.~   "
68333|NCT02672527|"~     As the transparency committee of the Haute Autorité de Santé pointed out due to lack of data~     regarding comparative trial of Yondelis versus best supportive care, activity of Yondelis in~     soft tissue sarcoma remain to be assessed.~      For an antineoplastic drug toxicity is moderate. As previous studies shown, overall survival~     data for patients with advanced or metastatic STS are of poor prognosis despite improvement~     of results this last years. For example, median overall survival increased from 12,3 months~     (1987-1991) to 11,4 months (1992-1996) and then 18 months (2002-2006).~      Considering the latest results with and without Trabectedin, the investigators may consider~     that comparing Trabectedin with best supportive care is ethically acceptable as long as~     patients consent to enter the trial.~   "
88317|NCT02411110|"~     This is a safety and efficacy study of LiRIS® in females with interstitial cystitis/bladder~     pain syndrome.~   "
68314|NCT02672774|"~     The aim of the project is to study the role of minimally invasive imaging methods, such as~     magnification endoscopy with narrow-band imaging (M-NBI) combined with confocal laser~     endomicroscopy (CLE), in correlation with immunohistochemical analysis, for assessing the~     angiogenesis status of patients with gastrointestinal tumors, in particular with colorectal~     and gastric cancer. Angiogenesis, i.e. the process of forming new blood vessels, represents~     an essential event for tumor growth and metastasis and the importance of its understanding~     stems from potential applications for diagnosis, prognosis stratification and mainly from the~     possibility of developing and improving targeted therapies. While current methods for~     evaluating tumor vascularity are based on immunohistochemistry techniques with microvascular~     density (MVD) calculations, these imply repeated tissue sampling and are not feasible in the~     context of clinical practice. Imaging techniques might overcome limitations associated with~     MDV measuring, obtaining both functional and morphological information and enabling repeated~     evaluations that are necessary for the assessment of a dynamic process as angiogenesis during~     follow-up of targeted therapies.~      NBI is a digitally enhanced endoscopic imaging technique that uses optical filters to~     illuminate tissue with light at blue and green wavelengths. These are selectively absorbed by~     hemoglobin and, as a result superficial vascular networks are highlighted and morphological~     changes in capillary patterns can be described for different lesions. CLE represents a~     revolutionary technology that enables endoscopists to collect real-time in vivo histological~     images or virtual biopsies of the gastrointestinal mucosa during endoscopy, and has raised~     significant interest for the potential clinical applications and numerous research~     possibilities. After intravenous administration of fluorescein as a contrast agent, CLE~     enables real-time visualization of the tumor vasculature, which is structurally and~     functionally altered compared to the normal vascular networks. Therefore M-NBI will be used~     for enhanced visualization of morphological changes of the superficial capillaries, while CLE~     will be directed towards vascular regions of interest for characterization of these changes~     at the microscopic level. Furthermore, imaging studies will be backed by MVD calculation~     using immunohistochemical methods, based on tissue samples harvested during endoscopic~     procedures.~   "
68315|NCT02672761|"~     Meditation improves attention and memory by reducing of the increased electric brain activity~     induced by a high stress level. This is associated to neuroplastic changes (volume reduction~     and/or neuron's density increases) in various brain structures. The question evolves if~     memory improvement by a standardized meditation program of 8 weeks (Mindfulness Based Stress~     Reduction MBSR) or a specific memory training (My Brain Training MBT) is a specific effect on~     brain networking or mediated by a reduced general activity induced by stress reduction. Thus,~     meditation or memory training should have differing neuroplastic effects.~      The effects of memory function improvement by the respective training will be measured by~     MAT, a specific and validated computerized memory and attention test. Brain morphology is~     investigated by voxel based morphometry NMR before and immediately after an 8 weeks~     intervention period. Stress levels are measured by cortisol profiles of subjects. Compared~     were 4 groups- MBSR group- MBSR students after completed training, passive control group-~     subjects following an 8 weeks waiting period for the MBSR training without any memory~     training, active control MBT group- subjects on an 8 weeks waiting period for the MBSR~     training doing an 8 weeks MBT memory training instead, Wellness group - doing a structured~     program using relaxing massage and calming computerized chair (Brain Light).~      The hypothesis of the study is that MBSR improves memory function better than MBT when~     measured by MAT. Compared to both active and passive controls, MBSR training induces specific~     morphologic changes in the brain, indicated by a volume change of the voxel based morphometry~     method of 5% of a defined brain region. In comparison to smaller and less neuroplasticity~     induced by MBT on memory brain regions, MBSR induces greater volume changes on hippocampus~     and amygdala and stress reduction than the wellness program.~   "
68316|NCT02672748|"~     The Growing Resilience research leverages reservation-based assets of land, family, culture,~     and front-line tribal health organizations to develop and evaluate home food gardens as a~     family-based health promotion intervention to reduce disparities suffered by Native Americans~     in nearly every measure of health. Home gardening interventions show great promise for~     enabling families to improve their health, and this study aims to fulfill that promise with~     university and Wind River Indian Reservation partners. The investigators will develop an~     empowering, scalable, and sustainable family-based health promotion intervention with, by,~     and for Native American families and conduct the first RCT to assess the health impacts of~     home gardens.~   "
68317|NCT02672735|"~     The occupation of firefighting is considered to be one of the most dangerous occupations in~     the United States (U.S.). As such, a high prevalence of musculoskeletal injuries (MSKIs) have~     been observed among the firefighter population. This high rate of MSKI has created an~     extremely large financial impact on fire departments across the United States. Therefore,~     interest in developing methods of identifying those at risk for developing a future MSKI and~     interventions designed to prevent these MSKIs from happening has grown among both the~     firefighter population, as well as among researchers and practitioners.~      Previous research has demonstrated relationships between MSKI and altered movement patterns.~     In addition, researchers have started to demonstrate the ability of functional movement~     assessments to predict future MSKI in various populations, including firefighters. Two of~     these functional movement assessments include the Functional Movement Screen (FMS) and the~     Movement Efficiency (ME) Test, which is a component of the Fusionetics Human Performance~     System. These assessments both quantify the overall functional movement quality of an~     individual by creating a composite movement score (i.e., Total FMS & Average ME Test scores,~     respectively).~      In addition, various theoretical models of corrective exercise programming have been~     proposed. These programs are designed to restore optimal neuromuscular control and correct~     any identified neuromuscular imbalances observed during the movement assessment through the~     use of simple and easy-to-follow exercises. The Fusionetics Human Performance System utilizes~     one such model, with the goal of improving the functional movement quality of an individual~     by correcting the aforementioned neuromuscular deficiencies observed during the ME Test.~     Based on this framework, these corrective exercise programs theoretically lower the risk of~     MSKI of the individual as well.~      However, there is currently a lack of research in the literature examining the influence of~     corrective exercise programming on functional movement quality among the active-duty~     firefighter population. As such, it remains unknown if a corrective exercise intervention is~     capable of significantly improving functional movement quality among active-duty~     firefighters. In addition, recent research suggests that various health and fitness measures~     are associated with functional movement quality. These measures include total body power~     output, lower extremity muscular strength, and core muscular endurance. As such, an~     examination of the influence of a corrective exercise intervention on measures of health and~     fitness among active-duty firefighters is warranted.~   "
68318|NCT02672722|"~     Renal parenchymal blood flow can be divided in cortical and medullary blood flow. Changes and~     factors affecting renal medullary blood flow have not been studied in detail previously as~     investigators/doctors did not have tools to monitor renal medullary blood flow in vivo. Since~     Trueta first described renal medullary blood flow, multiple attempts have been made to study~     renal medullary blood flow using invasive methods. Recently renal medullary blood flow~     measurement using contrast US has emerged as a promising technique that investigators can use~     to study renal medullary blood flow in vivo. In this study investigators are aiming to study~     changes in renal parenchymal (cortical and medullary) blood flow with exercise in healthy~     subject.~   "
68319|NCT02672709|"~     This study aims to determine the effects of end-stage renal disease on the pharmacokinetics,~     pharmacodynamics, safety, and tolerability of apixaban. This is a single-center open-label~     pharmacological study. Apixaban will be prescribed at the dose of 2.5 mg twice per day for~     nine days. The concentration of the drug will be measured with repetitive blood tests the~     first and the eighth day of administration (non-dialysis days). The same blood tests will be~     repeated before, during, and after dialysis on dialysis days. If the study shows inadequate~     or suboptimal efficacy with the 2.5 mg dose, it will be repeated with the 5 mg twice-daily~     dose.~   "
68320|NCT02672696|"~     The aim of the study is to compare Tip-Apex Distance values in two groups of patients after~     intramedullary nailing of proximal femur. The first group of patients is operated with the~     help of a 3D reconstruction device connected to the standard fluoroscopy allowing the surgeon~     to visualize directly the exact position of the tip of the trans-cervical screw while the~     second group (which is the reference-group) is operated with the help of fluoroscopy alone.~   "
68334|NCT02672514|"~     The aim of this study was to prospectively evaluate MECC compared with conventional~     extracorporeal circulation of diabetic patients undergoing elective coronary~     revascularization procedures. The investigators focused on the effects of extracorporeal~     circulation especially the renal function between both groups.~   "
68322|NCT02672670|"~     The aim of this proposed PhD study is to test the effectiveness of a newly developed~     coping-oriented supportive programme (COSP) for Chinese people with SCI during their early~     period of inpatient rehabilitation in Xi'an, China. The objectives of this study are to~     develop and validate the COSP in the inpatient rehabilitation hospitals; and to evaluate the~     effectiveness of this COSP for the SCI inpatients in two rehabilitation wards on their coping~     abilities, self-efficacy, mood status, and life satisfaction, when compared to those~     receiving routine care in another two rehabilitation wards. This proposed PhD study is a~     quasi-experimental study, using repeated-measures, comparison group design. The study will be~     conducted in two rehabilitation hospitals in Xi'an, China. There will be 50 patients in each~     of the two study groups (i.e., one intervention and one comparison group). The intervention~     group will receive the COSP including 8 weekly sessions, and the comparison group will~     receive usual rehabilitation care in brief didactic group-based education. Outcome measures~     will be examined at baseline and immediately, 1- and 3-month after completion of the~     interventions. The primary outcomes of this proposed study are coping ability and~     self-efficacy, while the secondary outcomes include mood status, life satisfaction, and pain.~     All data will be analysed using SPSS for Windows, version 21.0. Descriptive statistics will~     be employed for demographic and disease-related data and outcome scores. Data analysis for~     intervention effects will be based on both Per-protocol (PP) analyses and Intention-To-Treat~     (ITT). The missing data will be handled by the Last Observation Carried Forward (LOCF)~     strategy. Inferential statistics will be conducted for between-group and within-group~     comparison with specific considerations with the measurement level of the data and the~     fulfillment of the statistical assumptions of parametric or non-parametric tests, and further~     consider to use multivariate analysis of covariance (MANCOVA) or the analysis of covariance~     (ANCOVA).This study will provide evidence on the clinical effectiveness of the~     coping-oriented supportive programme in improving patients' psychological adjustment to SCI~     during earlier stage of inpatient rehabilitation, enhancing their psychosocial adaptation to~     the illness and subsequent life satisfaction and hence, integrating this psychosocial~     intervention into the conventional treatment and SCI rehabilitation practices.~   "
68323|NCT02672657|"~     Patients face multiple stresses and challenges in the aftermath of cancer diagnosis. Despite~     needs perceived by elderly patients might differ from those of younger patients, there is a~     paucity of published data assessing the specific evolution and relevant determinants of~     health-related quality of life (HRQoL) in older patients with cancer. Such determinants may~     include cancer type/location/stage, treatment type/intensity, comorbidities, nutritional~     status or socioeconomic features, but also practical organization of care -frequency,~     geographical distance, supporting measures -, or psychosocial and material support - social~     network, housing conditions and contextual neighborhood features. Comparatively to dementia~     or cancer in younger patients, little is known in the oncogeriatric field of the impact on~     caregivers' perceived burden and HRQol of the support they provide to patients. Further, the~     potential interactions between patients' and caregivers' HRQoL remain largely unknown, while~     caregivers are often themselves old with chronic diseases and/or daily living activities'~     limitations.~      The DEQOLAGE study is a prospective observational cohort study that aims to describe the~     HRQoL of patients aged over 70 years with a colorectal or prostatic cancer during the first~     year following the diagnosis of the disease as well as the HRQoL and burden in their main~     caregivers. This study will allow a comprehensive assessment of multiple determinants of~     HRQoL operating at different levels, including individual (cancer type/location/stage,~     treatment type/intensity, comorbidities, nutritional status or socioeconomic features),~     contextual (social network, housing conditions and contextual neighborhood features) and~     organizational factors (frequency, geographical distance, supporting measures). We also~     hypothesize that complex interactions may operate between patient's and caregiver's HRQoL and~     perceived burden. Quality of life measurement will be based on two recent scales specifically~     designed for the elderly to confirm their psychometric properties and in-field feasibility.~   "
68324|NCT02672644|"~     Study is designed to characterize subject and treating investigator reported outcomes in the~     early post-treatment period, following bilateral correction of nasolabial folds using Emervel~     Classic and Emervel Deep.~        1. to evaluate subject-reported return to social engagement, after the initial treatment~          (Baseline/Day 1 visit).~        2. to evaluate change in Global Aesthetic Improvement Scale (GAIS) at day 30-~          subject/investigator reported~        3. to evaluate subject satisfaction with treatment outcome at baseline, day 14 and day 30.~        4. to evaluate change in Wrinkle Severity Rating Scale (WSRS) from baseline to~          post-treatment follow-up time points at day 14 and Day 30 - investigator reported~        5. to evaluate all adverse events during the course of the study~   "
68325|NCT02672631|"~     The aim of this study is to determine whether clinical, sensory and motor development~     correlated with the values obtained from Electroneuromyography and DTI in postoperative~     follow up patients who underwent primary repair after the total median nerve injuries.~      Median nerve is one of three major nerves of hand and forearm and often injure with glass~     etc, in follow up of healing; clinical examination and ENMG are often used. Both of these~     methods are subjective, noninvasive and objective new method is required. In this context;~     differences between intact, recovering and not healed nerve tissue's diffusions have led to~     the hypothesis; The recovery of the repaired nerve tissue can be monitored by Diffusion~     Tensor Imaging method.~   "
68326|NCT02672618|"~     The purpose of this study is to explore manifestations of Heart Failure Using Infrared~     Thermal Imaging Technology.~   "
68327|NCT02672605|"~     This study is a randomized controlled trial designed to measure abortion stigma related to~     the Pennsylvania Abortion Control Act. Women seeking abortion will be randomized to receive~     the validated Individual Level Abortion Stigma Scale either before or after consent via the~     Pennsylvania Abortion Control Act language. The primary outcome will be the stigma scores in~     the two groups.~   "
68328|NCT02672592|"~     Obesity and the metabolic syndrome in men are associated with a high prevalence of~     hypogonadism of up to 50%. Increased fat mass leads to augmented release of adipocytokines~     and pro-inflammatory cytokines such as IL-1-beta, IL-6 and tumor necrosis factor-alpha which~     in turn suppress the hypothalamic-pituitary-gonadal (HPG) axis, leading to hypogonadism. This~     pathophysiological interplay is termed hypogonadal-obesity-adipocytokine hypothesis. TestIL~     is a prospective, multicenter, randomized, double-blinded, placebo-controlled trial to test~     the hypothesis that inhibition of IL-1-activity diminishes the inhibitory effects on HPG axis~     and increases testosterone levels in men with metabolic syndrome.~   "
68329|NCT02672579|"~     This purpose of this study is to validate two measures of chronic itching in kids: itch~     severity (ItchyQuant) and the impact on their quality of life (ItchyQoL).~   "
68330|NCT02672566|"~     Intrauterine growth restriction (IUGR) is correlated to an abnormal placenta development,~     with an alteration of the maternal-fetal circulation, coagulation troubles, and apparition of~     placental infarcts. IUGR represents the third cause of perinatal mortality in France, and is~     associated to an important morbidity. For birth-weights < 10th percentile of the gestational~     age, the neonatal death risk is doubled, compared to abnormal weights. In 35% of cases, IUGR~     is of vascular origin and is included in the broader framework of placental vascular~     pathology (PVP).~      Up to now, studies have focused on the primary or secondary prevention of PVP. Few studies~     have evaluated the treatment of constituted vascular IUGR. Currently, the management of~     vascular IUGR is mainly based on active surveillance, or termination of pregnancy.~     Pathological findings suggest that placental pro-thrombotic phenomena play a role in the~     constitution of vascular IUGR. Since aspirin is not effective in reducing this type of event,~     a randomized, open-label study conducted in China compared 14-day treatment with~     low-molecular-weight heparin (LMWH) versus Dan-Shen (a product not used in France) after~     diagnosis of IUGR. This trial, including 73 patients, showed a significant improvement in~     average growth kinetics in the LMWH group. The mean birth weight was 2877 g in the heparin~     group and 2492 g in the Dan-Shen group (p <0.0001). However, no data were provided concerning~     the number of newborns with a birth weight <10th percentile, i.e. the risk of morbidity and~     mortality, or complications occurring. Due to the lack of reliable data, LMWH are not~     included in the currently recommended therapeutic strategy for vascular IUGR.~      The studies in IUGR reported to date mainly focused on primary or secondary prevention in~     women at risk of PVP, assessing the value of aspirin, which showed only a modest effect. No~     effective therapeutic strategy is available to treat patients with constituted vascular IUGR,~     a situation where LMWH should be more effective than antiplatelets given the vascular~     context.~   "
68335|NCT02672501|"~     In the conventional treatment options, B cell leukemia could be treated with chemotherapy~     drugs or HSCT. But chemotherapy could barely cured leukemia. And HSCT is often limited by~     lacking of HLA-matched donors, even if those patients who received HSCT still could be~     relapsed. And now, chimeric antigen receptor modified T cell infusion maybe an effective~     treatment to solve these problems. The investigators use a 2nd CAR- T with the optimized~     hinge and transmembrane domain to treat patients with relapsed or refractory B cell leukemia,~     including relapsed cases after HSCT. The purpose of this study is to assess the safety and~     efficacy of this 2nd CAR-T cells. At the same time, evaluating the possible and clinical~     responses of using donor-derived T cells engineered CAR-T cells.~      Detailed Description: This study is being conducted to assess anti-CD19-CAR-T cells safety~     and efficacy in treating patients with B cell leukemia. The investigators constructed a 2nd~     CAR, CD19 as target protein, 4-1BB as co-stimulator. And optimized the spatial conformation~     by a suitable hinge & transmembrane domain sequences. The source of T cells for CAR-T is from~     two aspects, one is autologous, the other is donor-derived (only suitable for patients~     received HSCT before and relapsed). The infusion dose is (1-5)×106 CAR positive T cells/kg,~     and the specific cells numbers depend on the situation of individual CAR-T cells preparation.~   "
68336|NCT02672488|"~     Metformin is a widely used oral drug for type 2 diabetes and its antitumor effects have got~     much more attentions recently. It has been shown that metformin exerts anti-cancer activities~     in several cancers, including primary liver cancer. In this phase II study, safety and~     efficacy of the combination of metformin and sorafenib will be evaluated in patients with~     advanced hepatocellular carcinoma.~   "
68337|NCT02672475|"~     This phase I trial studies the side effects and best dose of Galunisertib when given together~     with paclitaxel in treating patients with androgen receptor negative or triple negative~     breast cancer that has spread to other places in the body. Some tumors need growth factors,~     which are made by the body's white blood cells, to keep growing. Galunisertib may interfere~     with growth factors and help cause tumor cells to die. Drugs used in chemotherapy, such as~     paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Giving~     Galunisertib together with paclitaxel may kill more tumor cells.~   "
68338|NCT02672462|"~     A single center, self-controlled pilot study on safety and efficacy of renal denervation in~     treatment of hypertension.~   "
68339|NCT02672449|"~     The aim of this research project is to test the feasibility and safety of a new treatment~     schedule for high risk prostate cancer that allows the administration of high doses to the~     prostate tumor with a mixed beam approach of carbon ions boost followed by pelvic IMRT.~   "
68340|NCT02672436|"~     The objective of this study is to evaluate the efficacy and safety of ENERGI-F703 in subject~     with diabetic foot ulcers.~   "
68341|NCT02672423|"~     The purpose of this study is to measure how much abemaciclib gets into the blood stream and~     how long it takes the body to get rid of it when given as capsules versus a tablet(s). The~     effect of a high fat meal on the tablet formulation will also be evaluated. In addition, the~     tolerability of abemaciclib tablet and capsule formulations will be evaluated. Information~     about any side effects that may occur will also be collected.~      This study has 3 parts. Parts A and C will last about 44 days including follow-up. Part B~     will last about 60 days including follow-up. Screening may occur up to 28 days before the~     first dose of study drug. Participants are only allowed to enroll in one part.~      This study is for research purposes only and is not intended to treat any medical condition.~   "
68342|NCT02672397|"~     The purpose of this study is to see if an educational intervention provided to pregnant women~     in early labor has an effect on their decision to use epidural anesthesia for relief of labor~     pain. The study will also investigate differences between Hispanic and non-Hispanic white~     women in their attitudes and beliefs regarding epidurals in labor. Previous studies have~     shown that Hispanic women receive epidural anesthesia in labor much less frequently than~     their non-Hispanic white counterparts. The investigators hypothesize that the rate of~     epidural use will be higher in subjects who receive the educational intervention than in~     those who do not.~      Women who have been admitted to the OHSU labor and delivery unit will be screened for study~     eligibility. In order to minimize the influence of socioeconomic factors, only women~     receiving Medicaid will be enrolled. Other inclusion criteria include age of at least 18~     years, having a fetus of at least 24 weeks gestational age, and being categorized as American~     Society of Anesthesiologist category 1 to 3. Exclusion criteria include any condition that~     either excludes or mandates neuraxial anesthesia. Midwife patients are also excluded from~     this study. Those who meet study criteria will be approached by a member of the study team~     and informed consent will be obtained.~      Subjects will be randomly assigned to receive an educational intervention about epidurals or~     no educational intervention. Hispanic and non-Hispanic subjects will be randomized~     separately, yielding four study groups (Hispanic - intervention; Hispanic - control;~     non-Hispanic - intervention, non-Hispanic - control). The investigators expect to enroll~     approximately 176 women, 44 in each group.~      All subjects will complete a survey in early labor and again 1 to 2 days postpartum that asks~     about common beliefs and misconceptions regarding epidurals. Subjects in the intervention~     group will receive an educational pamphlet and watch a video in their native language~     (spanish or english) about epidurals, and have an opportunity to ask questions. Study staff~     will collect limited information about the subject's labor and delivery from the electronic~     medical record.~   "
68343|NCT02672384|"~     This study evaluates the diagnostic performances of Point of Care P. gingivalis test in~     saliva with serum IgG P. gingivalis, in reference to dental examination as a gold standard in~     patients hospitalised in intensive care unit (ICU)~   "
68344|NCT02672371|"~     The study is a randomized clinical trial that is assessing the effects of sensory training on~     pain modulation, cognition, and physical endurance (time to fatigue) in healthy participants~   "
68345|NCT02672358|"~     This is an open-label, multicenter, non-randomized, single arm, phase II study to assess~     efficacy and safety of the dabrafenib and trametinib combination in Japanese patients with~     any line, stage IV NSCLC harboring a confirmed BRAF V600E mutation.~      Patients will receive oral dabrafenib twice daily and oral trametinib once daily combination~     therapy. Patients may continue study treatment until disease progression, unacceptable~     adverse events, start of a new anti-cancer therapy, consent withdrawal, death, or end of the~     study. Patients who have met the criteria for disease progression (PD) according to RECIST~     v1.1 may continue to receive study treatment if the investigator believes the patient is~     receiving clinical benefit and the patient is willing to continue on study treatment. After~     discontinuation of study treatment, all patients will be followed for survival until death,~     lost to follow-up, withdrawal of consent, or end of study.~   "
68403|NCT02671591|"~     The overarching goal of the proposed study is to determine effective outreach methods~     designed to recruit and improve acceptance of high-risk HIV-negative YBMSM to initiate PrEP~     and to identify and modify psychosocial and structural predictors of PrEP acceptance.~     Specifically, the objective of this pilot study is to test the feasibility of a motivational~     interview-based intervention designed to improve PrEP acceptance among YBMSM.~   "
68346|NCT02672345|"~     Cardiac surgery has evolved considerably after the advent of cardiopulmonary bypass (CPB), a~     feature that allowed more precision and tranquility to the heart surgeon. But their influence~     on exacerbation of inflammatory response can unbalance the whole homeostasis so happens~     surgical trauma. The attenuation of the systemic inflammatory response in major surgeries~     like cardiac surgery for aortic aneurysm appears to represent an important advance in~     reducing morbidity and mortality of these patients. Some studies suggest that inhaled~     anesthetics such as sevoflurane appear to play an important role in this control, but the~     mechanism by which this happens is still unclear. This study has the primary purpose of~     analyzing from a clinical study sevoflurane inhalation anesthetic can change the inflammatory~     response induced by CPB, significantly reducing the release of inflammatory markers,~     especially elastase PMN.~   "
68347|NCT02672332|"~     This is a 12 week, multi-center, double-blinded, randomized, vehicle-controlled, parallel~     group, study to be conducted in approximately 1300 subjects with acne vulgaris in the US.~   "
68348|NCT02672319|"~     Bleeding from gastroesophageal varices is one of the major complications of cirrhosis. After~     successful treatment of the acute bleeding episode, patients who do not receive follow-up~     treatment to prevent rebleeding were reported to have a rebleeding rate of 60% within 1- 2~     years. The presence of liver cancer and/or portal vein thrombosis has been associated with~     recurrent variceal bleeding. In a study of liver cancer patients in Hong Kong, 7.9% of~     patients developed at least 1 episode of variceal bleeding over the course of liver cancer.~      In patients with portal hypertension from cirrhosis, current guidelines recommend~     non-selective beta-blocker, endoscopic band ligation for esophageal varices after initial~     bleeding, and either cyanoacrylate injection for variceal obturation or transjugular~     intrahepatic portosystemic shunt for gastric varices after initial bleeding. However, it is~     unclear whether the above strategies will have the same clinical effect for patients with~     liver cancer and/or portal vein thrombosis who are at high risk for recurrent bleeding.~      Recently, the technique of endoscopic ultrasound (EUS) guided cyanoacrylate (glue) injection~     for variceal obturation has been described. In a study of patients with gastric variceal~     bleeding, EUS guided glue injection and coiling was reported to achieve hemostasis in all~     patients and 96% of the gastric varices remained obliterated during the follow-up period. To~     date, there has been no dedicated study to evaluate the role of EUS guided glue injection for~     prevention of future bleeding in patients at high risk for recurrent variceal bleeding such~     as those with liver cancer or portal vein thrombosis.~      The investigators propose this study to evaluate the feasibility and safety of EUS guided~     glue injection for follow-up variceal treatment in patients at high risk for recurrent~     variceal bleeding, such as those with liver cancer and/or portal vein thrombosis.~   "
68349|NCT02672306|"~     The primary purpose of this study is to evaluate the safety and the efficacy of (Human~     Umbilical Cord-Derived Mesenchymal Stem Cells) UCMSCs for patients with Alzheimer's disease~     (AD).~   "
68350|NCT02672293|"~     Over 20 million people in North America (including 2 million Canadians) have chronic kidney~     disease. These individuals die from diseases of the heart and blood vessels more often than~     they need dialysis. This is due to hardening of the arteries caused by calcium deposits~     inside the blood vessel walls. These deposits damage the vessels, causing them to lose~     flexibility. This makes them unable to respond to the changing demands of the body, and~     eventually leads to blockages such as stroke and ultimately death.~      High levels of phosphate in the blood have been consistently linked to the development of~     calcium deposits inside blood vessel walls. The kidney is the only organ in the body that can~     eliminate phosphate that is not required by the body. As kidney function becomes worse, body~     levels of phosphate increase. However, investigators do not know the time point in the course~     of kidney disease that problems begin in the way phosphate is eliminated into the urine by~     the kidneys. Investigators will test the response of the kidneys to a phosphate challenge~     taken by mouth in subjects who are having accurate measures of kidney function performed by a~     method called 'inulin clearance'.~      The investigators believe that the results of this study will provide important information~     identifying when investigators should be concerned about body levels of phosphate increasing.~     This information may lead to changes in the way investigators treat patients by reducing the~     levels of phosphate in the diet at a much earlier time point then is presently recommended.~   "
68351|NCT02672280|"~     The purpose of the present study is to evaluate the safety and exploratory efficacy of the~     medical collagen membrane with umbilical cord derived mesenchymal stem cells in the treatment~     of patients with skin defects.~   "
68352|NCT02672267|"~     The purpose of this study is to assess the safety, tolerability and preliminary efficacy of~     human allogeneic ischemia tolerant mesenchymal bone marrow cells (aLoOxMBMC) administered~     intravenously to subjects with Acute Myocardial Infarction (STEMI, non STEMI).~   "
68353|NCT02672254|"~     The gold treatment for local invasive cutaneous squamous cell carcinoma is surgical excision.~     Nevertheless, surgery is not always an option as a consequence of the age and/or the health~     status of the patient. One of the objectives of this study is to assess the effects of~     cisplatin concomitantly with a subsequent low-energy X-rays irradiation in vitro. In order to~     enhance the effectiveness of this combined treatment, the temporal fractionation of the~     platinated compound is expected to be performed.~   "
68354|NCT02672241|"~     The purpose of this study is to evaluate the safety and efficacy of nimotuzumab in~     combination of radio-chemotherapy for the treatment of brainstem tumor in children.~   "
68355|NCT02672228|"~     This is a proof of concept study that will evaluate the feasibility of a vapor nanobubble~     technology (MalariSense) for malaria diagnostics. The MalariSense technology will use a~     highly innovative approach based on the transdermal non-invasive detection of vapor~     nanobubbles produced by the excitation of malaria-specific hemozoin by safe, low-energy laser~     pulse. The objectives of this study will be to determine the sensitivity and specificity of~     MalariSense in diagnosing malaria in malaria suspected cases attending a health facility in~     The Gambia and to identify factors influencing the diagnostic accuracy of MalariSense~   "
68356|NCT02672215|"~     A theory-driven, web-based, computer-tailored advice to influence sitting at work was~     developed. The study investigated the effects of this computer-tailored intervention to~     influence workplace sitting on behavioural measures.~   "
68357|NCT02672202|"~     To create a data base that will facilitate the enrichment of the insights regarding~     post-operative pain development, and to identify those individuals with the potential to~     develop this kind of pain. The identification will be based on the individualized pain~     modulation profile, composed of a battery of tests as detailed below.~   "
68358|NCT02672189|"~     The current study will evaluate systematically the efficacy and cost-effectiveness of two~     internet-based CBT/relaxation programs (one guided, the other self-managed) in reducing the~     severity of menopausal symptoms and improving copings skills with regard to hot flushes and~     night sweats as well as improving sexual functioning, improving quality of sleep, reducing~     emotional distress and improving quality of life in younger breast cancer patients who~     experience treatment-induced menopause.~   "
68359|NCT02672176|"~     The overall goal of this proposal is to enhance the supports and resources available to~     patients with diabetes to assist them to achieve their health goals. The investigators will~     evaluate an innovative program that uses nurse health coaching, motivational interviewing~     techniques, wireless sensors and mobile health (mHealth) technology. In this program,~     patients will receive timely, tailored nurse coaching feedback to facilitate behavior change~     using mHealth technology, thus bridging bidirectional exchange of meaningful information~     among patient, nurse coach and provider. The investigators will conduct a randomized~     controlled trial among patients receiving chronic disease management at the University of~     California, Davis Primary Care Network. The patients who are eligible for inclusion in the~     study will be randomized to one of two arms of the trial: 1) Usual care (Care Coordination)~     administered by UC Davis Health Management and Education; or 2) the Patient and Provider~     Engagement and Empowerment through Technology (P2E2T2) Program to Improve Health in Diabetes.~     The hypothesis is that patients in the P2E2T2 arm of the study will be more engaged in~     identifying and achieving health goals related to their diabetes and will achieve better~     health outcomes compared to patients receiving usual care.~   "
68360|NCT02672163|"~     This study aims to evaluate the safety and clinical feasibility of epicardially delivered~     autologous atrial appendage micrografts in the treatment of heart failure. The micrografts~     consisting atrial-derived cells and their extracellular matrix, are placed on an infarction~     scar during CABG surgery.~   "
68361|NCT02672150|"~     This is a multi site experiment to evaluate the impact of various strategies for increasing~     the use of evidence based screening, assessment and linkage to substance use treatment. All~     sites collect baseline data and receive a core intervention. Half are then randomly assigned~     to get an additional year of coaching to facilitate implementation.~   "
68362|NCT02672137|"~     Cluster randomized open-label experimental study multi-center of 24 hospitals to either~     knowledge translation vs usual care to improve care of patents hospitalized for acute~     coronary syndromes.~   "
68363|NCT02672124|"~     The aim of this study is to evaluate the microbiological safety and the efficacy of a new not~     expensive, easy and fast technique (Direct Microswimup) for sperm preparation in In Vitro~     Fertilization (IVF) treatments without the use of centrifuge, able to simplify the procedure~     and to avoid mismatches by ensuring the same results of the standard techniques in terms of~     fertilization rate, blastulation rate, pregnancy/abortion rate, cryostorage rate, and a~     better euploid status of the embryos.~   "
68364|NCT02672111|"~     Open-label multi-center, 12-month safety study, consistent with standard practice for~     long-term safety studies. This one year safety study will utilize CAM2038 q1w (once weekly)~     and q4w (once monthly) and will have 3 phases: Screening, Treatment, and Follow-up.~   "
68365|NCT02672098|"~     This is a phase I prospective study with the primary objective to compare the efficacy and~     safety of Surgical cytoreduction (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC)~     in treatment of recurrent ovarian, primary peritoneal or fallopian tube cancers. Eligible~     patients consenting to this protocol will undergo their scheduled surgical procedure. After~     surgical cytoreduction to a residual disease ≤ 2.5 mm, a single dose of carboplatin (800~     mg/m2) will be administered in normal saline via intraperitoneal hyperthermic perfusion using~     the closed-abdomen. HIPEC will be continued for 90 minutes in the hyperthermic phase~     (41°C-43°C). At 4-6 weeks after CRS, patients will go on to receive 6 cycles of standard IV~     platinum-based chemotherapy. The proportion of patients who are without evidence of~     recurrence will be assessed at 6, 9, 12 and 18 months after the day of surgery.~   "
68366|NCT02672085|"~     Background and Rationale:~      Tedious PRP infiltrations are emerging treatments for tendinopathies and tendon tears. It has~     been showed effective in different parts of the body, but current evidences for rotator cuff~     PRP infiltration remains poor. Some studies that tested infiltrations on transfixing lesions~     showed no statistically significant effect of PRP on tendon healing. The investigators~     believe that this might be explained by a flushing effect of PRP into subacromial space or~     glenohumeral joint. Therefore, it was decided to focus this study on interstitial lesions, in~     which PRP is entrapped into the lesion for a long time.~      Objective:~      The purpose of this study is to evaluate whether intra-tear PRP infiltrations promotes tear~     repair better than needling procedures of torn tendon in participants with supraspinatus~     interstitial tears.~      As secondary objective, we will study symptoms alleviation in same way. Primary outcome:~     Primary outcome: Supraspinatus tear size change from baseline will be compared between cases~     receiving two PRP injections and controls receiving torn tendon needling, 6 months after~     second injection.~      Secondary outcomes: Single Assessment Numeric Evaluation score, Constant score, ASES score,~     Shoulder pain disability index, and Visual analogue scale changes from baseline will be~     compared between cases receiving two PRP injections and controls receiving torn tendon~     needling, 0,1,3, and 6 months after second injection.~      Study design: This case-control study is randomized 1:1 between PRP (intervention group) and~     needling (Control group). It is a superiority trial that will include 84 patients suffering~     from interstitial supraspinatus tears. As adjuvant therapy, patients from each arm will~     beneficiate from standard physical therapy program. PRP and needling will be repeated 2~     times, at one month interval. First injection will occur up to two months after recruitment.~     Clinical follow-up will occur from second injection to one year after second injection, with~     clinical parameters evaluation at 0,1,3, and 6 months after second injection, and control MRI~     6 months after second injection.~      Study Product / Intervention: Supraspinatus tendon needling with intralesional PRP injection.~     PRP will be extracted with Regenlab® extraction kit. No other medications used.~      Control Intervention (if applicable): Supraspinatus tendon needling with intralesional saline~     water injection.~      Number of Participants with Rationale: 84 patients will be needed (37 in each group). A 10%~     of dropout has been taken in consideration.~      Study Duration: 24 months from recruitment of the first patient to the last follow-up visit.~     Scientific report will be written within the two months following recruitment of the last~     patient.~      Study Schedule: First-Participant-In: 01.6.2015 Last-Participant-Out: 30.6.2017~   "
68367|NCT02672072|"~     I. Main outcome Decrease of the stress evaluated 6 months after training. Stress is defined~     as the presence of job strain as defined by Karasek.~      II. Main secondary outcomes~        -  ICU nurses stress at one year~        -  Burnout~        -  Intent-to-leave the ICU~        -  Quality of life~      III. Design~      Prospective, randomized, open study comparing 2 groups of ICU nurses:~      Simulation group and Control group~      Nurses from 9 different adult ICUs will be included. Stratification by ICU will be done (to~     take into account differences between the ICUs regarding organization, activity, patients…).~      This study is observational because nurses can participate to this training when they want.~     The fact that nurses are in control group delays their participation to this training but~     does not forbid them to particpate. The nurses from control group will participate to~     training at the end of study.~      IV. Specific measures Control group: none~      Simulation group: 5-day specific training with dedicated scenario done by an ICU expert~     simulation team~      V. Study duration 48 months~      VI. Ethical aspects - Reglementary concerns~        -  Study accepted by the Comité Consultatif sur le Traitement de l'Information en matière~          de Recherche dans le domaine de la Santé (CCTIRS) and by the Commission Nationale de~          l'Informatique et des Libertés (CNIL)~        -  Information to the participants prior inclusion~      VII. Study population Job strain evaluated in a French study was 59% . The same rate was~     observed in a survey done in our institution (Assistance Publique Hôpitaux de Marseille). We~     therefore hypothesized that the intervention (simulation) should be able to reduce the job~     strain from 59% to 45% of the participants. With a power of 80% and a risk a of 5%, this~     study needs to include 185 patients per arm. To take into account few participants who will~     not complete the study, we aimed to include a total of 400 ICU nurses.~      VIII Results An interim analysis will be performed after 200 inclusions~   "
68440|NCT02671110|"~     This study compared the recently developed Transforming Your Life (TYL) weight loss program~     to the Diabetes Prevention Program (DPP), considered the Gold Standard in behavioral weight~     loss treatment.~   "
68368|NCT02672059|"~     In the context of peripheral neuropathy, we will aim to elucidate correlates between sensory~     symptoms and:~        -  Sensory nerve dysfunction.~        -  Cutaneous small nerve fibre innervation density.~        -  Psychological co-morbidity.~        -  Circadian rhythm disturbance co-morbidity.~        -  Functionality and Quality of life.~        -  Patterns of human brain activity in a subset of patients that consent to participate in~          the FMRI (functional magnetic resonance imaging) component of PINS.~           2. We will also collect blood samples in this phenotyped cohort of patients. These blood~          samples coupled with detailed phenotype data will investigate potential gene~          associations only in the development of painful neuropathy.~           3. Knowledge gained from the study will be used to aid the further development of pain~          questionnaires, designed to detect patients with painful neuropathy.~           4.Knowledge gained from the study will be invaluable in informing on-going~          investigations of painful peripheral neuropathy in animal models, both in our laboratory~          and others.~   "
68369|NCT02672046|"~     The aim of the study is to evaluate an algorithm to screen patients with a possibility of~     meniscal injury referred to a sports injury outpatient clinic by using patient-reported~     symptoms. It will be investigated whether the algorithm is able to identify which patients~     are deemed relevant to undergo assessment by a physician (i.e. in case the patient need to~     undergo surgery) and which patients are relevant to undergo assessment by a physiotherapist.~     This will be evaluated by estimating the sensitivity of the new algorithm compared to actual~     relevancy based on the traditional clinical assessment of the patients.~   "
68370|NCT02672033|"~     This pilot phase 0 trial studies accelerated hypofractionated radiation therapy immediately~     before surgery in treating patients with malignant pleural mesothelioma (cancer in the thin~     layer of tissue that covers the lungs and lines the interior wall of the chest cavity).~     Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors.~     Hypofractionated radiation therapy is a type of radiation therapy in which the total~     prescribed dose of radiation is divided into fewer but larger doses as compared to~     conventional radiation therapy. Giving accelerated hypofractionated radiation therapy~     immediately before surgery may improve survival, and may also reduce side effects experienced~     by patients with pleural mesothelioma.~   "
68371|NCT02672020|"~     Malignant pheochromocytoma/paraganglioma (MPP) and adrenocortical carcinoma (ACC) are two~     rare cancer entities with a very unfavorable prognosis. The knowledge on these rare cancers~     improved thanks to the French COMETE network originally based on two clinical centers (HEGP~     and Cochin) well organized for clinical and biological samples collection. Over the last 10~     years, the COMETE key partners deciphered molecular mechanisms of tumorigenesis and~     oncogenesis of these tumors and identified molecular signatures discriminating between benign~     and malignant cancers by integrated genomic approaches. This strategy was highly successful~     in delivering new diagnostic applications of genomics technologies that now appear as~     potentially suitable for rapid implementation in routine clinical care.~      The main objective of COMETE-TACTIC is to provide an easy-to-use identity card of the~     adrenal tumors that will allow a personalized à la carte management of the patient and,~     when indicated, to the indication of the most accurate molecular targeted therapy.~      We hypothesize that the improvement of MPP and ACC diagnosis and of the therapeutic options~     proposed to affected patients will require,~        1. the transfer to routine practice and the prospective validation of the novel diagnostic~          and predictive biomarkers issued from recent discoveries (genetics, genomics,~          histological biomarkers);~        2. the implementation of the translational research projects based on the COMETE collection~          to identify circulating diagnostic, prognostic and therapeutic genetic and metabolic~          biomarkers that could be used as non-invasive liquid biopsies.~   "
68372|NCT02672007|"~     This study aims to investigate these research questions:~        1. Is there a difference in the results obtained, when respiratory rate is measured~          automatically by an electronic device (SensiumVitals® system, Sensium Healthcare)~          compared with a research assistant using a criterion standard approach?~        2. Is there a difference in the results obtained, when respiratory rate is measured~          automatically by an electronic device (SensiumVitals® system, Sensium Healthcare)~          compared with hospital staff's current clinical practice?~   "
68373|NCT02671994|"~     In a randomized controlled trial, the investigators wish to investigate, if oncologic~     treatment decision based on G8 screening followed by geriatric assessment and subsequent MDT,~     if needed, in older frail patients with gynaecologic and urologic cancer is superior to~     standard assessment (PS and clinical assessment) in oncologic treatment decision.~   "
68374|NCT02671968|"~     Demonstrate that usage of RT-CGM (Real time continuous glucose monitoring) reduces the~     frequency of low CGM-recorded glucose events in patients using MDI (Multiple daily~     injections) that are at risk for hypoglycemic events.~   "
68375|NCT02671955|"~     The purpose of this study is to evaluate the safety and tolerability of JNJ-61610588 in~     participants with advanced cancer in order to determine a recommended Phase 2 dose (RP2D) for~     further evaluation in specific tumor types.~   "
68376|NCT02671942|"~     To evaluate the safety and pharmacokinetics of different dose roflumilast in China COPD~     patient.~   "
68377|NCT02671929|"~     The purpose of this study is to determine the feasibility and effectiveness of an~     internet-based self help program concerning satisfaction with the treatment and their life,~     depression and anxiety. Both study groups get access to the internet-based self-help program.~     The intervention group receives additional feedback to their progress in the program from an~     online therapist. The investigators hypothesize that (1) at least 75% of the patients in the~     intervention group are satisfied or very satisfied with the self-help program, (2) 50% of~     the patients in the intervention group work with all eight units and (3) patients of the~     intervention group have a higher emotional competence than the patients of the control group~     at the end of the self-help program.~   "
68378|NCT02671916|"~     The goal is to capture the Quality of life and survival of patients one year after the stay~     at ICU. Data will be collected during the stay in the ICU and evaluated. One year after the~     ICU stay patients will be send a Quality of Life questionnaire they need to fill out and~     return. All data will be evaluated together.~   "
68441|NCT02671097|"~     Evaluation of the potential perpetrator effect of BAY1841788 (ODM-201) on rosuvastatin~     pharmacokinetics.~      PK of BAY1841788 (ODM-201) after single and repeated administration in male and female~     subjects.~   "
68379|NCT02671903|"~     This is a multi-centre, prospective randomised double-blinded cross over study, recruiting a~     sub-population of patients with heart failure.~      All patients will be implanted with a CRT (Cardiac Resynchronisation Therapy) pacemaker with~     one of the leads positioned on the His bundle in order to obtain direct His-bundle capture.~     There will be a 2-month run-in period where the device is not active.~      A double-blinded cross-over design will then be employed to investigate the effect of His~     bundle pacing. Patients will be allocated in random order to six month treatment periods in~     each of the following two states (1) No pacing; (2) AV optimised direct His-bundle pacing.~     Endpoint measurements will be taken at baseline, 6 months and 12 months post randomisation.~     Treatment allocation will be blinded to the endpoint assessor and the patient.~      126 patients will be needed to detect the expected effect size on the primary endpoint with~     90% power. A total of 160 patients will be recruited to allow for patient drop-out.~   "
68380|NCT02671890|"~     This partially randomized phase I trial studies the side effects and best dose of disulfiram~     when given together with gemcitabine hydrochloride in treating patients with a solid tumor~     that cannot be removed by surgery (unresectable) or pancreatic cancer that has spread to~     other places in the body (metastatic) and to compare whether disulfiram and gemcitabine~     hydrochloride may reduce tumor induced muscle loss. Weight loss occurs in pancreatic cancer~     patients and is common in a multitude of other cancers. Patients with metastatic cancer and~     weight loss sometimes are not able to receive treatment due to physical weakness or debility.~     Disulfiram is a potential inhibitor of muscle degradation and may reduce tumor induced muscle~     wasting. Disulfiram may also help gemcitabine hydrochloride work better by making tumor cells~     more sensitive to the drug. Drugs used in chemotherapy, such as gemcitabine hydrochloride,~     work in different ways to stop the growth of tumor cells, either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading. It is not yet know whether~     giving gemcitabine hydrochloride with or without disulfiram is a better treatment for~     unresectable solid tumors or metastatic pancreatic cancer.~   "
68381|NCT02671877|"~     The aim of this study is the evaluation of preoperative transnasal fiberoscopy, as a possible~     predictor of difficult laryngoscopy and intubation during elective general anesthesia in an~     adult population.~      Transnasal fibercoscopy is a minimally invasive examination and is routinely performed during~     ENT evaluation; on the other hand, current strategies used to predict the ease of intubation~     are still not sufficiently sensitive and specific, and an unexpected difficult or failed~     intubation at the induction of general anesthesia is a seriuos, and potentially fatal,~     emergency in anesthesia.~      In literature, a correlation between anatomical and functional parameters highlighted by~     fiberoscopy and difficulty of laryngoscopy and intubation has never been demonstrated nor~     indagated.~      If proven, this might give the Anesthestiologist further information about the expected~     difficulty of laryngoscopy and intubation, guiding a different - and hopefully safer -~     anesthesiological strategy.~   "
68382|NCT02671864|"~     Experimental data suggest that GLP-1 promote endothelial cell growth and angiogenesis which~     may have beneficial effects on the cardiovascular system but harmful effects on the retina .~     This project investigate the possible link between incretin therapy and Severe Diabetic~     Retinopathy. The prevalence of severe DR in patients exposed to incretin therapy (GLP-1~     analogs or DPP4 inhibitors) is compared to that in non-exposed patients to these antidiabetic~     classes.~   "
68383|NCT02671851|"~     Background: Thoracic paravertebral blocks (TPVBs) have been effective for postoperative~     analgesia in mastectomy, thoracic and video-assisted thoracic surgeries.~      Objective: To assess whether addition of ultrasound-guided TPVBs to general anaesthesia (GA)~     could postpone time to first pain and improve postoperative analgesia in patients undergoing~     bilateral reduction mammoplasty.~      Design: A historical cohort study. Patients: Of the 70 female patients who underwent~     bilateral reduction mammoplasty, 64 patients had complete data in the acute pain/regional~     anaesthesia database.~      Intervention: Thirty patients, received only GA, were included in Group GA. Thirty-four~     patients, received bilateral single injection ultrasound-guided TPVBs with 20 mL bupivacaine~     0.375% as an adjunct to GA, were included in Group TPVBs. Patients in both groups were~     administered intraoperative fentanyl if heart rate or mean arterial pressure increased >20%~     above pre-induction values, postoperative tramadol 1mg/kg in the postoperative care unit~     (PACU) if numeric rating scale (NRS) was ≥4, and rescue analgesics as metamizole sodium 4x1g~     and/or paracetamol 3x1g on wards (NRS≥4).~      Main outcome measures: The primary endpoint was time to first pain after the surgery.~     Secondary endpoints were intra- and postoperative opioid and other rescue analgesic~     requirements, length of stay in the PACU, pain scores, incidence of postoperative nausea and~     vomiting (PONV), and patient and surgeon satisfaction through the postoperative first 2 days.~   "
68384|NCT02671838|"~     Non-adherence to medications can lead to sub-optimal treatment in rheumatoid arthritis (RA)~     patients. In order to improve disease modifying anti-rheumatic drugs (DMARDs) adherence, the~     investigators are conducting a randomized controlled trial to test out an intervention to~     improve medications adherence among low adherers. This intervention involves the use of a~     musculoskeletal ultrasound program which allows RA patients to visualize their joint~     inflammation and damage real time while treatment adherence is simultaneously reinforced. In~     doing so, the investigators hope to improve patients' understanding of their joint disease~     and motivate the participants to adhere to their medications.~   "
68385|NCT02671825|"~     The purpose of this study is to compare drug blood levels of multiple formulations of inhaled~     PUR0200 to each other and to the reference product with and without oral charcoal.~   "
68386|NCT02671812|"~     The general aim of this project is to investigate the long-term treatment outcome after~     implant therapy. The patients' satisfaction with implant treatment will be studied and~     correlated to biological and technical problems. The survival rates of implants at patient~     level and the degree of bone loss of remaining teeth and implants will be calculated. The~     levels of cytokines and bone loss markers in peri-implantitis sites and periodontal defects~     and at healthy sites will be analyzed in order to study the correlation between cytokine and~     bone loss marker levels, and clinical conditions. Independent variables which could be~     regarded as significant risk factors or risk predictors on the incidence of peri-implantitis~     are aimed to be identified~   "
68387|NCT02671799|"~     This is a prospective, multi-center, single-arm study to evaluate the VenTouch System for~     treatment of moderate to moderate-severe functional mitral valve regurgitation [FMR].~   "
68388|NCT02671786|"~     Provision of community based health care to severely malnourished children (Age group: 6~     months through 5 years) in 16 tribal villages by trained semi-literate village health~     workers.~        1. Treatment of severely malnourished children.~        2. Growth monitoring of all children below the age of 5 years.~        3. Treatment of associated diseases like Diarrhea, Pneumonia, Malaria, etc.~        4. Management of resistant or relapsed severely malnourished cases by pediatrician.~        5. Intensive behavior change communication of parents of children below the age of 5 years~          for proper nutrition.~   "
68389|NCT02671773|"~     Previous work has determined that there are significant differences in the communities of~     bacteria found in the airways of asthmatic patients compared to those found in the airways of~     healthy people.~      It is not yet clear if these bacterial communities are similar in all patients with asthma or~     if they are different in people with more severe asthma, with different types of asthma or~     between asthma patients taking different treatment. This is important to know as any~     differences in the bacteria present between groups may help to explain why people with asthma~     do not have the same features of disease.~      This research aims to determine if there are any differences in the number and type of~     bacteria found in the airways of asthmatic patients (1) with different severities of asthma~     and (2) who use different types of inhaled steroid treatment for asthma.~      We will do this by detecting the DNA of bacteria present in phlegm samples from these~     patients. We will also take measurements of the different components of asthma to see if the~     bacteria are different in people with different types of disease.~      As it is not yet clear if the bacteria detected in phlegm samples from one person may differ~     on different occasions, we will be taking more than one sample from some patients to see how~     similar this is over time.~   "
68390|NCT02671760|"~     The purpose of this study is to evaluate the effect of a combination drug product containing~     diphenhydramine, zolpidem and lorazepam on total sleep time. Participants will be adults who~     sometimes have difficulty falling asleep or staying asleep, but who do not have chronic~     insomnia. The study involves 3 one-night stays in a sleep center in New York City.~   "
68391|NCT02671747|"~     The study is to pilot-test an innovative, combined urinary/bowel continence workshop in two~     Wisconsin communities. Between 8-15 women with incontinence will be enrolled in each of the~     two pilot communities and will complete three 90-minute workshop sessions over a 6 week~     period.~   "
68392|NCT02671734|"~     The investigators employed a randomized control study design to evaluate the efficacy of a~     video intervention augmenting informed consent discussions in improving parental and youth~     informed consent comprehension.~   "
68393|NCT02671721|"~     The purpose of this pilot study is to identify the optimal way to ventilate patients during~     abdominal surgery in order to reduce the amount of post-operative pulmonary complications in~     patients at moderate and high-risk for them.~   "
68394|NCT02671708|"~     Autologous hematopoietic stem cell transplantation (Auto-HSCT) is an effective alternative to~     allogeneic HSCT for intermediate-risk acute myeloid leukemia (AML) without HLA-matched~     donors. At present, the best conditioning regimen for AML undergoing auto-HSCT remains in~     discussion. In this study, the safety and efficacy of IDA+BUCY and BUCY myeloablative~     conditioning regimens in intermediate-risk AML undergoing auto-HSCT are evaluated.~   "
68395|NCT02671695|"~     the aim of this study is to evaluate the effect of Spirulina compared to Amlodipine on~     cardiac iron overload and cardiac functions in multi-transfused children with beta~     thalassemia major~   "
68396|NCT02671682|"~     This observational study investigates the efficacy and safety of immunoadsorption versus~     plasmapheresis in 60 patients with relapse in Multiple Sclerosis and Clinically isolated~     syndrome who do not fully recover after a high doses of intravenous corticosteroids.~   "
68397|NCT02671669|"~     This is a randomized controlled trial of the feasibility and utility of implementing a~     smartphone application (MVN) to maintain compliance with a Heart Healthy lifestyle after~     discharge from a cardiac outpatient rehabilitation program. Patients will be randomized into~     one of two groups: usual care (control: UC) or Movn mobile application (intervention: MVN).~     This study will improve and strengthen data collection from this at-risk patient population~     by recording baseline clinical and psycho social measures while gaining insight into~     self-reporting of physical activity and frequency between the UC and MVN groups.~   "
68398|NCT02671656|"~     Lowering the level of uric acid in the serum under 6mg/dL on the long term is a key factor of~     gout management success. Monitoring of uricemia in gout patients is therefore important and~     is presently done in the laboratory on serum samples obtained after venous puncture. This~     study aims at assessing the reliability of immediate uricemia measurement in a blood sample~     obtained by a mere fingertip puncture, by the HumaSensplus system, which is commercially~     available in the EU. Results obtained by the Humasens device will be compared to those of the~     standard measurement technique in serum and with a reference technique (liquid chromatography~     and mass spectroscopy). If the device appears reliable, it will allow self-measurement of~     uric acid by the gouty patient, in a similar way as diabetic patients measure their glycaemia~     following a fingertip puncture. This should improve patient monitoring and management~     effects.~   "
68399|NCT02671643|"~     Purpose: To determine the measurement properties of the asthma control test (ACT) in a~     prospective clinical study in an African American adolescent population.~   "
68400|NCT02671630|"~     Little is known about the effects of computerized cognitive training programs on mild~     dementia patients' health. The purpose of this study was to examine the effects of a~     community-based computerized cognitive training program.~   "
68401|NCT02671617|"~     This randomized control trial will determine the effect of short term high intensity interval~     training (HIIT) on physical fitness, in an elderly patient group with active cancer, prior to~     surgical resection.~      Half of the recruited patients will act as a control group and the other half will undergo a~     HIIT protocol.~   "
68402|NCT02671604|"~     In patients undergoing robot-assisted radical prostatectomy (RARP), pneumoperitoneum,~     intraoperative fluid restriction and prolonged Trendelenburg position may cause~     rhabdomyolysis (RM) due to hypoperfusion in gluteal muscles and lower extremities.~      In this study, it was aimed to assess effects of BMI, comorbidities, intraoperative~     positioning, fluid restriction and length of surgery on development of RM in RARP patients~     during perioperative period.~   "
68404|NCT02671578|"~     BACKGROUND: The degree of consciousness during nitrous oxide use is still a matter of concern~     for both dentists and anesthesiologists. Investigators hypothesized that BIS levels do not~     vary according nitrous oxide concentration during minimum to moderate sedation in the dental~     treatment.~      METHODS: One hundred patients undergoing dental procedures demanding local anesthesia (1.8 mL~     of 2% lidocaine with 1:100.000 epinephrine) were enrolled in this study. Initial pain and~     anxiety were measured by 11-point numerical and anxiety visual scales, respectively.~     Systolic/diastolic arterial blood pressure, SpO2, heart and respiratory rates, and~     psychomotor ability (Trieger test) were assessed before, during and after dental treatment.~     Sedation levels were evaluated by both BIS and sedation analogic scale at the same intervals.~     The duration of treatment along with nitrous oxide concentration and side effects were~     observed. Kruskal-Wallis, Friedman and Mann-Whitney tests were used (alpha=5%).~   "
68405|NCT02671565|"~     Osteoarthritis (OA) is a degenerative joint disease in which there is an imbalance between~     the breakdown and repair of the joint tissue. Intraarticular hyaluronic acid (HA) injections~     are used for the management of knee OA. Currently, there is limited and inconclusive evidence~     supporting use of HA injections for management of knee OA. The primary objective of our study~     is to evaluate the effectiveness of HA injections in the management of knee OA. Investigators~     will evaluate if HA injections prevent or delay knee OA surgical interventions.~   "
68406|NCT02671552|"~     This pilot clinical trial compares the imaging results of contrast-enhanced ultrasound to~     contrast-enhanced magnetic resonance imaging (MRI) or computed tomography (CT), the current~     clinical standard, in predicting treatment response in patients with kidney cancer undergoing~     cryosurgery (a procedure in which an extremely cold liquid or an instrument called a~     cryoprobe is used to freeze and destroy abnormal tissue). Using contrast-enhanced ultrasound~     that does not involve a dye may help patients avoid side effects from a dye that is usually~     used in MRI or CT and may help doctors measure blood flow and determine whether the~     cryosurgery procedure treated the kidney tumor.~   "
68407|NCT02671539|"~     An open label monocentric phase II trial in adult males with a clinical phenotype of~     choroideremia and a confirmed molecular diagnosis of a null mutation in the gene encoding~     REP1 to assess the anatomical and functional outcomes, as well as the safety of a single~     subretinal injection of rAAV2.REP1 in 6 subjects with genetically confirmed choroideremia for~     up to 24 months.~   "
68408|NCT02671526|"~     This study is a validation study to document the acceptability of the revised~     Plasticity-based Adaptive Cognitive Remediation (PACR) program to patients with~     HIV-associated Neurocognitive Dysfunction (HAND). The primary objective of this study is to~     evaluate the effects of the revised PACR program on the cognitive abilities (e.g., attention,~     executive function), functional status and quality of life of individuals diagnosed with~     HAND. The secondary objective of the study is to collect relevant data to support a~     pre-investigational device exemption (IDE) submission to the FDA required before the pivotal~     randomized, controlled trial planned for Phase II.~   "
68409|NCT02671513|"~     SHR6390 is a small molecular,oral potent, selective CDK4/6 inhibitor. The purpose of this~     study is to investigate the safety/tolerability and the pharmacokinetic profile of SHR6390 in~     Chinese advanced melanoma patients by using a 3+3 dose escalation.Preliminary efficacy will~     be also investigated in this study.~   "
68410|NCT02671500|"~     This study will evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir~     (SOF)/velpatasvir (VEL; GS-5816) fixed-dose combination (FDC) for 12 weeks in treatment-naive~     and treatment-experienced participants with chronic hepatitis C virus (HCV) infection.~   "
68411|NCT02671487|"~     The purpose of this study is to determine whether war-traumatize male adolescents with~     behavioral and emotional problems who participate in mind-body skills groups will have~     improvement in behavioral and emotional problems, aggression, and posttraumatic stress~     disorder (PTSD) symptoms, compared to a wait list control group.~   "
68412|NCT02671474|"~     A single-center prospective interventional trial. Patients implanted with a sutureless~     bioprosthetic aortic valve at Karolinska University Hospital in Stockholm, Sweden from 2012~     will be eligible. 4-dimensional volume-rendered computed tomography (CT) of the heart will be~     performed. The aim of the CT is to assess valve leaflet motion. Results of the CT~     examination, preoperative clinical characteristics, and postoperative clinical data will be~     registered. Data will be collected prospectively and retrospectively. Informed consent will~     be obtained from patients meeting the inclusion criteria before the initiation of any~     study-specific procedures.~   "
68413|NCT02671461|"~     The purpose of this study is to determine whether BMS-986141 is effective in reducing the~     recurrence of stroke in people who recently had a stroke, or a transient ischemic attack~     (known as a TIA or mini stroke) and are receiving acetylsalicylic acid (also known as~     aspirin or ASA) to treat the stroke or TIA.~   "
68414|NCT02671448|"~     In this study, the investigators plan to see what happens when a person receives care in the~     home setting. They want to find out if caring for a patient who has been treated with an ASCT~     in the home setting is feasible. They want to find out what effects good and/or bad this will~     have on the patient's recovery and treatment after ASCT. Studies in other institutions have~     shown that providing care in the home setting after ASCT is safe, increases patient~     satisfaction, and can decrease the risk of infection. It is our hope that this new approach~     of providing care in the home setting will prove to be a feasible and safe option for~     patients at Memorial Sloan Kettering Cancer Center (MSK).~   "
68415|NCT02671435|"~     This is a multicenter, open-label, dose-escalation, dose-exploration and dose-expansion study~     to evaluate the safety, tolerability, antitumor activity, PK, pharmacodynamics, and~     immunogenicity of Durvalumab (MEDI4736) in combination with monalizumab (IPH2201) in Adult~     Subjects with selected advanced solid tumors and the combination of durvalumab and~     monalizumab (IPH2201) standard of care systemic therapy with or without biological agent~     administered to subjects with recurrent or metastatic colorectal cancer (CRC).~   "
68416|NCT02671422|"~     At present there are no approved predictive tumour- or serum-derived biomarkers guiding usage~     of anti-angiogenic therapies in patients with adenocarcinoma of NSCLC.The objective of this~     NIS is to examine whether genetic/genomic markers (alone or combined with clinical~     covariates) could be used to predict OS in NSCLC patients eligible for treatment with~     Vargatef®. The investigations in this study are exploratory in nature and considered to be~     hypothesis generating. The results from these investigations may help to expand our~     understanding of the disease and the response to Vargatef®.~   "
68417|NCT02671409|"~     The spinal nerve injury in humans often results in neuropathic pain characterized by~     spontaneous burning pain accompanied by allodynia and hyperalgesia. In this sense,~     lomboisquiatalgia is a neuropathy that is characterized by narrowing the intervertebral~     foramen of the lumbar vertebrae, leading a lumbar chronic pain which irradiate to a lower~     limb, being a clinical condition of difficult treatment. Neural Mobilization is a noninvasive~     technique used by physiotherapists. The technique aims to restore mobility and elasticity of~     the peripheral nervous system by tenses which are imposed on the roots, nerves, spinal cord~     and their respective meninges. This technique has been standardized in basic research and has~     shown promising results. However, clinically, this technique lacks randomized, controlled and~     double blind studies. Therefore, the investigators have to evaluate the effects of Neural~     Mobilization technique in patients with lomboisquiatalgia. In this study the investigators~     will treat patients three times a week, with ten minute treatment time per session, with 25~     oscillations per minute for ten sessions. Many tools will be used to assess the effects of~     the protocol applied, for example: evaluation sheet, visual analogue scale (VAS), quality of~     life assessment - WHOQOL-bref questionnaire of Roland Morris disability, oswestry index on~     disability (version 2.0), enzyme-linked immunosorbent assays for the measurement of cytokines~     in the blood tissue. In this way, the investigators can contribute and understand the~     mechanisms involved in the rehabilitation process.~   "
68418|NCT02671396|"~     The present study is to examine the effects of a virtual reality based balance training using~     the Kinect sensor on postural stability and functional balance in individuals with~     Parkinson's disease.~   "
68419|NCT02671383|"~     This is a switch study to assess the non-inferiority (in terms of efficacy and safety) of~     darunavir (boosted with ritonavir, DRV/r 400mg/100mg daily) when compared with lopinavir~     (boosted with ritonavir, LPV/r total dose 800mg/200mg daily), in combination with a~     nucleoside backbone, administered as a second line therapy in HIV positive individuals.~   "
68420|NCT02671370|"~     This study there are any associations between objective and subjective outcome measures,~     measuring the cervical range of motion and if the restriction matter to the patient.~   "
68421|NCT02671357|"~     This prospective observational study aims to improve the postoperative course after minimally~     invasive pancreaticoduodenectomy (MIP) with stented pancreaticogastrostomy (sPG) for~     pancreatic head or peri-ampullary neoplasms. Patients are submitted to an enhanced recovery~     after surgery (ERAS) program.~   "
68422|NCT02671344|"~     Microarray experiments to assess the expression of thousands of genes providing vast amount~     of information.~      Because the molecular requirements in the different processes related to playback,on the~     hypothesis that there may be more apt semen samples for technical or other assuming molecular~     differences in RNA content messengers or gene expression profile between the They getting~     semen samples in gestation versus those who do not.~      In an attempt to give a functional data obtained view, it is to find out how many of these~     genes in donors who have obtained gestation, they are differentially expressed in playback~     related processes against those donors who did not get pregnant.~   "
68423|NCT02671331|"~     The loop duodenal switch (L-DS) is a single-anastomosis biliopancreatic diversion with~     duodenal switch (BPD-DS) procedure. The original BPD-DS has two-anastomosis and is an~     accepted and approved bariatric procedure by the American Society of Metabolic and Bariatric~     Surgery. Preliminary data from Sanchez-Pernaute et al. (2013) indicates that the L-DS~     procedure is safer and easier to perform as it only requires one anastomosis compared to the~     BPD-DS, and offers good results for treatment of both morbid obesity and its metabolic~     comorbidities, including type-2 diabetes mellitus. However, the initial publications of the~     loop DS still resulted in a small number of patients with total protein malnutrition. For~     this reason, the investigators will study the loop DS with a modification of the originally~     published technique with a longer common channel limb (300 cm) to reduce the risk of protein~     malnutrition For patients with a BMI >50, many are limited to just a sleeve gastrectomy as~     other bariatric procedures are technically challenging with increased operative risk. A loop~     duodenal switch may be a safer operation with improved weight loss for the super-morbidly~     obese patient.~   "
68424|NCT02671318|"~     Cytomegalovirus is the most important opportunistic infection after kidney transplant, with~     increased in mortality, morbidity and higher costs of transplantation. Despite the favorable~     efficacy (lower acute rejection) results of the most worldwide used regime, tacrolimus,~     mycophenolate and prednisone, or the investigators local common regimen, tacrolimus,~     azathioprine and prednisone, this combinations are associated with higher incidence of~     cytomegalovirus infection, disease and recurrence.~      Namely, sirolimus use is associated with decreased risk of cytomegalovirus infection/disease,~     and there is not a prospective cohort to evaluate the conversion to sirolimus efficacy to~     decrease the cytomegalovirus infection recurrence.~      Given this, the investigators propose a study of their own initiative that attends local~     needs: evaluate the conversion to sirolimus efficacy in decrease the cytomegalovirus~     recurrence after kidney transplant.~   "
68425|NCT02671305|"~     Preterm newborns receiving placental transfusion at birth (a volume of blood coming from the~     placenta towards the newborn till the cord is left unclamped) have better neonatal outcomes~     (in particular reduction of intraventricular hemorrhage all grade). The placental transfusion~     strategies performed in preterm babies at delivery have been delayed cord clamping and cord~     milking. Both experimental strategies do not explore the contribution of the start of~     breathing on placental transfusion, as performed in a small time frame (30-60 seconds for~     delayed clamping and less than 20 sec for cord milking). To assist the newborn bedside near~     to the delivering mother, leaving the cord unclamped, would allow to explore the contribution~     of breathing,both spontaneously started or assisted by initial steps in stabilization, on~     early postnatal adaptation.~      The purpose of the present study is to assess the feasibility and effectiveness of delivery~     room assistance with the placental circulation intact in comparison to cord milking for~     improving outcomes in very preterm newborns.~   "
68426|NCT02671292|"~     To determine whether reducing loss of control eating (LOC) with Interpersonal~     Psychotherapy-Weight Gain (IPT-WG) will be effective for adolescent military-dependents who~     report such behavior. The investigators will examine whether IPT-WG influences body weight~     gain trajectories and prevents worsening disordered eating, psychosocial problems, and~     metabolic functioning among military dependents at heightened risk for adult obesity and~     disordered eating. This study will provide key efficacy data for a new promising obesity~     prevention program for youth from military families.~   "
68427|NCT02671279|"~     This is a prospective study of morbidly obese patients that are planned to conduct bariatric~     surgery. The patients included in the study will conduct a low-calorie diet for 6 days prior~     to the operation and be admitted to hospital for this period. On admission and after~     finishing the diet a number of tests will be performed: Weigh, height, oral glucose tolerance~     test, bioimpedance measurement, and samples of blood, urine and a biopsy of subcutaneous~     adipose tissue.~   "
68428|NCT02671266|"~     The purpose of the current study is to investigate the effect of an acute administration of~     intranasal oxytocin, relative to placebo, on social cognitive impairments among individuals~     with body dysmorphic disorder and obsessive-compulsive disorder, compared to healthy~     controls.~   "
68429|NCT02671253|"~     This project focuses on myomectomy patients in reproductive age. The aim is to study both the~     molecular characteristics of uterine fibroids and to characterize the clinical effects of~     surgical treatment.~      Patient series is mainly retrospective and consists of individuals who have undergone~     myomectomy at Helsinki University Central Hospital (HUCH) during 2009-2015. In addition, the~     investigators have started a prospective sample collection starting in October 2015,~     collecting samples from myomectomies.~      Clinical data sources include medical records, specific questionnaires and a quality of life~     -questionnaire filled by patients.~   "
68430|NCT02671240|"~     Our hypothesis is that the conventional treatment of Behavioral Addiction in Parkinson's~     disease is often not effective, and that affects the motor aspects (worsening akinéto-rigid~     syndrome and / or worsening of dyskinesia due to higher levodopa doses to compensate for the~     drop in behavioral addictions) and non-motor (withdrawal syndrome dopamine agonist) anxiously~     including apathy.~      Our goal is to describe the natural history of Behavioral Addiction under the effect of the~     evolution of the disease and adapt treatment according to the prior art, through a study of a~     larger population of patients than in the few published studies.~   "
68431|NCT02671227|"~     The investigators aim to investigate the differences between intrathecal Bupivacaine + Mg~     sulfate in spinal anesthesia versus Bupivacaine on surgeon satisfaction and postoperative~     pain in gynecologic laparoscopic surgeries.~   "
68432|NCT02671214|"~     Identify one or more flat bread mixes that produce a reduction in positive incremental area~     under the curve (iAUC) of post-prandial glucose relative to the control product.~   "
68433|NCT02671201|"~     Emergency ultrasound examinations are increasingly important diagnostic tools in emergency~     and critical care medicine. This study wants to analyze different types of education for~     undergraduate students. Any method of medical training will be proved theoretical and in~     clinical practice.~   "
68434|NCT02671188|"~     Chemokine (C-C motif) ligand 20 (CCL20) is a protein involved in attracting immune cells~     including subsets of T cells (for example Th17 cells), B cells, natural killer cells and~     dendritic cells to inflamed tissues in conditions such as psoriasis (Ps) and psoriatic~     arthritis (PsA). CCL20 acts by binding and activating the chemokine receptor 6 (CCR6) present~     on the surface of the inflammatory cells. Levels of CCL20 are increased in inflamed tissues~     in psoriasis (Ps) and inflammatory arthritis. GSK3050002 is a humanized Immunoglobulin G~     (Ig)G monoclonal antibody, which binds to and neutralizes the action of human CCL20. The~     hypothesis is that GSK3050002 will reduce the movement of inflammatory cells into tissues~     affected by Ps or PsA, thereby leading to an improvement in disease activity. The primary~     objective of this multi-centre, randomized, double-blind (sponsor open), placebo-controlled~     trial is to evaluate the safety and tolerability of repeat doses of GSK3050002, and to~     understand the mechanism of action (by taking skin and synovial biopsy samples) and potential~     for clinical efficacy of GSK3050002 in subjects with PsA. A minimum of 18 subjects and up to~     a maximum of 30 subjects will be randomised into the study to either GSK3050002 or placebo in~     a 2:1 ratio to ensure that approximately 18 evaluable subjects complete the study. The total~     duration of participation in the study will be approximately 21 weeks from screening to last~     study visit.~   "
68435|NCT02671175|"~     This study evaluates the efficacy and safety of 3 months of malaria chemoprevention~     post-discharge using dihydroartemisinin piperaquine (DHA-P) in children under 5 years of age~     admitted with severe anemia. One half will receive monthly DHA-P and the other half placebo.~   "
68436|NCT02671162|"~     The purpose of this study is to determine whether Fumaria Parviflora L. can minimize severity~     of pruritus in patients with end-stage renal disease.~   "
68437|NCT02671149|"~     The aim of this study is to determine whether drinking plain water when mildly dehydrated~     benefits cognitive performance and mood. Volunteers undergo a dehydration protocol designed~     to result in minor dehydration. While some participants receive two 150ml drinks of water~     others do not. Differences in cognitive functioning are assessed.~   "
68438|NCT02671136|"~     Diabetes and Periodontitis are both prevalent diseases affecting millions of Americans.~     Periodontitis is prevalent among Diabetics. Furthermore, Periodontitis and associated~     inflammation can increase insulin resistance in Diabetics and worsens the condition.~     Hyperbaric Oxygen Therapy (HBOT) has the potential to improve periodontal treatment outcome~     in poorly controlled diabetics. The study will compare periodontal treatment (SRP) outcome~     between 2 main diabetic type 2 patient groups receiving medical care treatment: either~     Conventional Wound Therapies (CWC) with or without adjunctive Hyperbaric Oxygen Therapy at~     LLU Health.~      24 poorly controlled diabetic mellitus (DM) type 2 subjects (HbA1c =>7%) with Periodontitis~     will be assigned into the study arms HBO therapy and Non HBO therapy, based on their medical~     needs.~      For all subjects demographic data (age, gender, ethnicity, smoking history, alcohol use~     history, BMI, current medication list) and oral health habits will be obtained. Blood samples~     for HbA1c determinations, clinical periodontal measurements (plaque index, probing~     measurements including pocket depth, attachment levels, gingival index and~     bleeding-on-probing) and subgingival microbial samples will be obtained at baseline and end~     of the study. Subgingival microbial samples will be collected from three randomly selected~     sites and analyzed for detection of about 300 of the most prevalent oral bacterial species.~     Differences in periodontal clinical outcomes and bacterial profiles will be identified~     utilizing ANCOVA (Analysis of Covariance).~   "
68439|NCT02671123|"~     The purpose of this study is to determine whether co-registration of OCT and angiography~     reduce geographic miss defined as stent edge dissection or significant residual stenosis at~     stent edge after stent implantation during percutaneous coronary intervention.~   "
68442|NCT02671084|"~     Increase in CK-MB after percutaneous coronary angioplasty more than 100% of baseline can~     represents a problem to the patients resulting in increase of morbidity and mortality.~      Patients submitted of coronary angioplasty procedures can release in varying degrees of~     creatine kinase, MB isoform (CK - MB), on the order of 30% of all angioplasty.~      Possibly patients who will receive sevoflurane experience a higher level of cardiac cell~     protection with lower incidence in the release of CK - MB values in excess of 100% baseline.~   "
68443|NCT02671071|"~     The primary objective of this study is to describe the socio-demographic, clinical~     pathological, quality of life and treatment characteristics of patients diagnosed with CC in~     Brazil.~   "
68444|NCT02671058|"~     This study will be an open label, single dose, randomized, 2 way (2 period) crossover study~     in healthy adult subjects at a single study center.~   "
68445|NCT02671045|"~     Overall survival rates for patients with metastatic NSCLC are poor utilizing conventional~     cytotoxic chemotherapy approaches. However, a subset of patients harbor genomic driver~     mutations, which when targeted with specific therapies, experience improved outcomes.~      Unfortunately, identification of these mutations, although recommended in national~     guidelines, has been limited for a variety of factors including small biopsy samples. The~     broad application of a sensitive genomic profiling test, which simultaneously examines for~     multiple genomic alterations on limited biopsy material, could increase the identification of~     patients with actionable mutations and thereby improve survival in NSCLC. The FoundationOne~     test meets these requirements. A recent study using the FoundationOne assay identified a~     significant number of actionable mutations among NSCLC patients who were previously thought~     to be negative for mutations when tested using other approaches.~      This is a non-randomized observational comparative study with various cohorts based on~     physician diagnostic patterns of care and biologic genomic profile status. Survival and cost~     information will be compared based on different use of genomic profiling.~   "
68446|NCT02671032|"~     The purpose of the feasibility study is to examine audiological outcomes (audiometry and~     speech perception) and safety (adverse events and adverse device effects) with the Nucleus~     CI532 cochlear implant in group of adult subjects (n=12) who meet current criteria for~     cochlear implantation.~   "
68447|NCT02671019|"~     The purpose of this trial is to compare the effectiveness and costs of a five-module~     Internet-based treatment program (including therapist support) for harmful alcohol use with~     the effectiveness and cost of the same treatment content delivered face-to-face in~     specialized addiction treatment. The hypotheses to be tested through this trial are that:~        1. The Internet-based treatment program (including therapist support) is as effective~          (reducing alcohol consumption) as the same treatment content delivered face-to-face in~          specialized addiction treatment.~        2. The Internet-based treatment program (including therapist support) is associated with~          lower cost per treated individual in relation to the achieved effects (in terms of~          reduced alcohol consumption) compared with the same treatment content delivered~          face-to-face in specialized addiction treatment.~      The design is a two-armed randomized controlled trial, and outcomes are measured in terms of~     changes in alcohol consumption, problematic alcohol use as well as alcohol dependence,~     depression, anxiety, quality of life and costs for the treatments. A minimum of 350~     participants will be recruited and randomized into two groups:~      Intervention group 1: All participants in this group will have access to the five-module~     Internet-based treatment program for harmful alcohol use and have access to a therapist with~     training in psychotherapy (CBT) who assists and counsels the participant throughout the~     program.~      Intervention group 2: All participants in this group will attend five face-to-face treatment~     sessions in specialized addiction treatment.~   "
68448|NCT02671006|"~     A biological tool for quantitative assessment of Chronic Urticaria (CU) is still in need for~     monitoring biotherapies. CU is considered as a sudden degranulation of Mast cells / basophils~     without any identified cause. It is considered that Mast cell/basophil have an abnormally~     high sensitivity in CU and can be triggered with almost nothing (high irritability). In~     allergy, basophils degranulation can be reproduced in vitro with allergens. Anti-IgE~     (immunoglobulin E) antibody mimics allergen triggering of basophils in a dose dependent~     manner. If basophils are abnormally sensitive in CU, it should be reproduced in vitro at very~     low stimulation. The main objective of this project is to set up a method to evidence~     abnormal basophil irritability and look for clinical significance. As many markers~     characterize basophils in different states, researchers shall also look for a profile~     possibly associated with CU basophile irritability. Such tests could be useful in CU~     monitoring.~   "
68449|NCT02670993|"~     Alzheimer Disease (AD), characterized by cognitive and psycho-behavioral troubles, concerns~     essentially 65 years old and older patients. Antalgic and psychotropic treatments have~     adverse effects in old people, and have to be used carefully. To improve the pain support and~     limit the drug consumption, it is possible to perform therapies without drugs. Among them,~     musical intervention represents an interesting complementary support, to deal with physical~     and moral pain in AD.~   "
68450|NCT02670980|"~     This study evaluates the safety and effectiveness of the Intelligent Retinal Implants System~     (IRIS V2). Blind patient suffering from Retinitis Pigmentosa, Cone Rod Dystrophy, or~     Choroideremia are implanted with an Intelligent Retinal Implant Systeme. All subjects undergo~     ophthalmological examinations in predefined intervals after implantation. Ophthalmological~     examinations include funduscopy, slit lamp examination and OCT. All adverse events are~     recorded and analyzed. Efficacy is measured using functional vision and visual function tests~     before and after implantation as well as with the system on and system off.~   "
68451|NCT02670967|"~     The present study conducted a meta-analysis of 22 randomly controlled trials to assess the~     effects of soluble fiber intake on blood pressure in human subjects.~      Using the Cochrane Handbook for Systematic Reviews of Intervention, a systematic review and~     meta-analysis was conducted. Information regarding study methods, characteristics, mean BP~     and standard deviations were extracted The data from each study were pooled using a random~     effects model to estimate the effects of soluble fiber consumption on blood pressure.~   "
68840|NCT02665871|"~     This study evaluates the safety of freeze-dried live attenuated influenza vaccine for~     intranasal administration in chinese adults aged 3 years and older.80 subjects will be~     divided into 2 groups, including 18 years and older and 3-17 years old. Subjects in each~     groups will randomly receive one dose of influenza vaccine or placebo in a 3:1 ratio.~   "
68452|NCT02670954|"~     To evaluate the efficacy and safety of appropriate postoperative sedation with~     dexmedetomidine for patients after abdominal surgeries.Prospective randomised controlled~     study was conducted among patients after abdominal surgeries began in October 2015.The~     investigators enroll patients who received abdominal surgeries. One group receive sedative~     along with analgesic and the other group analgesic only for the other group on the first 24~     hours after surgeries and will follow up for 3 days.~   "
68453|NCT02670941|"~     The rationale behind the proposed study is to determine the initial effectiveness of~     aromatherapy in relief of commonly reported symptoms in cancer patients undergoing~     chemotherapy.~   "
68454|NCT02670928|"~     This study aims achieving of long-term weight loss in T2DM patients by use of comprehensive~     lifestyle changes program, providing patients with structured diet, exercise plan, group~     behavioral support and group education. Additionally the study is designed to establish~     reduction of the body weight leads to the improvement of glycemic and lipid metabolism, and~     can also reduce blood pressure level. The study is also directed to show that lifestyle~     changes program in T2DM patients can lead to decreasing of hospitalization rate and~     healthcare consumption. In order to demonstrate a change from standard of care, data will be~     collected from a parallel cohort from the same centers.~   "
68455|NCT02670915|"~     This trial is conducted globally. The aim of the trial is to investigate efficacy and safety~     of faster-acting insulin aspart compared to NovoRapid® both in combination with insulin~     degludec in children and adolescents with type 1 diabetes.~   "
68456|NCT02670902|"~     This research uses a multi-phase approach to adapt and implement an established intervention,~     Critical Time Intervention, for a new population and setting among individuals with~     co-occurring substance use and mental health problems who are at risk of relapse following~     residential substance abuse treatment. The goals of the study are to: (PHASE 1) identify~     challenges and strategies of community reentry among individuals with co-occurring problems~     in residential substance abuse treatment and their providers and social support networks~     (e.g., family, friends, community members); (PHASE 2) adapt CTI for individuals with~     co-occurring disorders in residential substance abuse treatment to prepare them for discharge~     and transition back into the community; and (PHASE 3) conduct a pilot study to examine the~     feasibility, acceptability, and preliminary outcomes of the adapted CTI compared to enhanced~     usual discharge planning services.~   "
68457|NCT02670889|"~     The purpose of this study is to determine if acetohydroxamic acid (AHA) can prevent~     hydrolysis of urea by inhibiting the bacterial urease of gut flora of both healthy control~     adults as well as adults with urea cycle disorders.~   "
68458|NCT02670876|"~     The investigators recruited school bullying perpetrators from the age of 12 to 17 by referral~     from the local police department. An anti-bullying intervention based on cognitive-behavioral~     therapy (CBT) principles was conducted, and addressed issues related to impulse control,~     empathy and communication enhancement. All participants completed brain magnetic resonance~     imaging, neurocognitive tests, and questionnaires before and after the intervention.~   "
68459|NCT02670863|"~     The purpose of this study is to evaluate the safety and efficacy of the experimental formula~     supplemented with a prebiotic vs the control formula.~   "
68460|NCT02670850|"~     Mild Cognitive Impairment (MCI) is a syndrome defined as a cognitive decline that is more~     severe than can be explained by an individual's age and education. One study in the United~     States found that MCI caregivers have experienced distress in association with caregiver~     burden. The prevalence of MCI for people age 65 and older ranges from 3% to 19%.~     Understanding the process of family caregiving provides a knowledge base for the health~     professionals when developing effective interventions. However, little is known about the~     phenomenon of family caregiving to patients with MCI in Taiwan.~      Therefore, the purpose of the proposed study is to develop a theoretical model and a~     model-based intervention program for family caregivers of patients with MCI in Taiwan, and~     pilot test it in a clinical trial.~   "
68461|NCT02670837|"~     Few but persistent wounds often remain even after successful hematopoietic cell~     transplantation for systemic genodermatosis epidermolysis bullosa (EB). The investigators~     propose local wound therapy using epidermal skin grafting from the same donor that provided~     the hematopoietic graft, or from the same EB individual with a mosaic (naturally gene~     corrected) skin. In both cases permissive immune system and skin chimerism is expected to~     enable long-term epidermal engraftment and wound healing. The investigators will use FDA~     approved vacuum device (CelluTome®, Regulation number 878.4820) that enables scar-free~     harvesting of epidermis and its transfer on a square of surgical tape (Tegaderm®) to the~     recipient as a wound dressing.~   "
68462|NCT02670824|"~     This study evaluates the safety, tolerability, and pharmacokinetics (PK) of a single~     escalating dose and repeated doses of CN-105 in healthy adult participants. There will be~     about 48 subjects, 36 active and 12 placebo.~   "
68463|NCT02670811|"~     The objective of the present work was to evaluate the antihypertensive effect associated with~     the consumption of fermented milk with Lactococcus lactis NRRL-B50571 on prehypertensive~     subjects.~   "
68464|NCT02670798|"~     The long-term goal of this study is to optimize the perioperative care of pediatric spinal~     deformity patients, minimizing perioperative complications and increasing cost-effectiveness~     of perioperative hematologic management. The objective of the proposed study, which is the~     initial step in pursuit of this goal, is to evaluate the effectiveness of thromboelastography~     (TEG) to monitor coagulation pathways and direct blood product replacement in pediatric~     neuromuscular spinal deformity surgery. The central hypothesis of this study is that TEG will~     decrease exposure to allogeneic packed red blood cells (PRBC). The rationale is that proven~     effectiveness of TEG in neuromuscular deformity may change the standard of care for~     hematologic management in neuromuscular spinal deformity cases and additionally set the stage~     for a multicenter trial in idiopathic pediatric deformity.~   "
68465|NCT02670785|"~     This study will access the safety and efficacy of three doses of estradiol vaginal capsules~     in postmenopausal women with vulvovaginal atrophy.~   "
68466|NCT02670772|"~     The purpose of this study is to demonstrate whether low dose stavudine (d4T) is non-inferior~     (in terms of both viral suppression and toxicity) to tenofovir (TDF) after 2 years of HIV~     treatment.~   "
81196|NCT02504112|"~     The objective of the observational study is to assess the positioning of customized guides~     designed from patients X-Rays (Zimmer® X-Ray PSI Knee) using optical navigation in primary~     total knee arthroplasty.~   "
68467|NCT02670759|"~     This study is designed to assess:~        -  The impact of continuous thoracic paravertebral nerve blockade compared to intercostal~          nerve blockade on the intensity of postoperative pain following VATS in subjects having~          a Patient Controlled Analgesia (PCA) device as their primary analgesic modality.~        -  The impact of continuous thoracic paravertebral analgesia on length of stay, opioid~          intake, respiratory function, incidence of side-effects and postoperative complications.~      The basic hypothesis of this study is that continuous thoracic paravertebral nerve blockade~     will provide superior postoperative analgesia following VATS when compared to intercostal~     nerve blockade in patients having a PCA device as their primary analgesic modality. Superior~     quality of analgesia should contribute to preserve pulmonary function, reduce opioid intake~     and related side-effects and shorten the hospital stay.~   "
68468|NCT02670746|"~     The objective of the study is to prospectively assess the use and treatment outcomes of~     nab-paclitaxel plus gemcitabine in pancreatic ductal adenocarcinoma in the Netherlands.~     Additional objectives are to monitor the incidence and reversibility of neuropathy during~     treatment, to assess the patient's Quality of life when treated with~     nab-paclitaxel/gemcitabine and to evaluate the use of resources that come with treating~     metastatic pancreatic cancer.~   "
68469|NCT02670733|"~     There are concerns that the use of positive end-expiratory pressure (PEEP) for the treatment~     of pulmonary complications in patients with brain injury may potentially elevate intracranial~     pressure (ICP), and deteriorate neurological status. It is suggested that both respiratory~     system compliance and ventricular compliance would contribute to the elevation of ICP when~     PEEP increases. In theory, PEEP may cause elevation of ICP by increasing intrathoracic~     pressure and diminish venous return. However, the transmission of PEEP into thoracic cavity~     depends on the properties of the lung and chest wall. Experimental study showed that when~     chest wall compliance is low, PEEP can significantly increases intrathoracic pressure;~     whereas low lung compliance can minimize airway pressure transmission. It is generally~     recognized that the lung compliance decreases in acute respiratory distress syndrome (ARDS)~     patients due to extensive alveolar collapse. However, it has been report that the elastance~     ratio (the ratio between elastance of the chest wall and the respiratory system, where~     elastance is the reciprocal of compliance) may vary from 0.2 to 0.8. Therefore, it is~     important to distinguish the compliance of the chest wall and the lung when investigating the~     effect of PEEP on ICP.~      Because intrathoracic pressure (pleural pressure) is difficult to measure in clinical~     situations, esophageal pressure (Pes) is considered as a surrogate of intrathoracic pressure.~     In the present study, the investigators determine the effect of PEEP on intrathoracic~     pressure and ICP by Pes measurement.~   "
68470|NCT02670720|"~     This is an open-label study designed to evaluate the long-term safety of prophylactic~     avoralstat (500 mg three times daily) when given to approximately 150 patients with~     hereditary angioedema (HAE) for a duration of up to 72 weeks. The study will also evaluate~     the long-term efficacy and impact on quality of life of avoralstat prophylactic treatment.~   "
68471|NCT02670707|"~     Langerhans Cell Histiocytosis (LCH) is a type of cancer that can damage tissue or cause~     lesions to form in one or more places in the body. Langerhans cell histiocytosis (LCH) is a~     cancer that begins in LCH cells (a type of dendritic cell which fights infection). Sometimes~     there are mutations (changes) in LCH cells as they form. These include mutations of the BRAF~     gene. These changes may make the LCH cells grow and multiply quickly. This causes LCH cells~     to build up in certain parts of the body, where they can damage tissue or form lesions.~      For most patients with LCH, standard-of-care vinblastine/prednisone are used as front-line~     therapy while cytarabine therapy has been used as therapy for patients who develop~     recurrence. No alternate treatment strategy has been developed for frontline therapy in LCH.~      The purpose of this research study is to compare previously used vinblastine/prednisone to~     single therapy with cytarabine for LCH. We will evaluate the utility of an imaging study~     called a positron emission tomography (PET) scan to more accurately assess areas of LCH~     involvement not otherwise seen in other imaging studies as well as response to therapy. We~     also want to identify if genetic and other biomarkers (special proteins in patient's blood~     and in patient's cancer) relate to the response of patients LCH to study treatment.~   "
68472|NCT02670694|"~     This study will investigate sleep behavior in subjects with Angelman Syndrome, Rett Syndrome~     or Prader-Willi Syndrome.~      The study will also investigate sleep behavior in healthy siblings of subjects with Angelman~     Syndrome, Rett Syndrome or Prader-Willi Syndrome. These individuals will serve as control~     subjects.~      The study will use questionnaires designed to identify sleep disorders and how they affect~     behavior and quality of life.~      The principal goals of this study are:~        1. To see how common sleep disorders are in individuals with Angelman Syndrome, Rett~          Syndrome or Prader-Willi Syndrome;~        2. To see how sleep disorders affect behavior in these individuals;~        3. To see whether sleep disorders and related behavior problems improve or worsen with age;~        4. To see how specific disease conditions relate to sleep disorders and how bad the sleep~          disorders are;~        5. To develop new treatment options to improve quality of life and behavior issues; and~        6. To evaluate current treatment options to improve sleep problems in these individuals.~   "
68473|NCT02670681|"~     The aim of this intervention study is to evaluate the acute and chronic effects of different~     intensity (mild, moderate and high intensity) of aerobic exercise on blood pressure levels of~     subjects classified as resistant hypertension. Resistant hypertensives subjects aged 40 to~     70, men or women with body mass index lower that 40 kg/m² are recruited and subjected in~     acute phase in three sessions of aerobic exercise: mild, moderate, high intensity; and~     session control. After, the subjects will be randomly allocated into four intervention~     groups: mild intensity group, moderate intensity group, high intensity group and control~     group. In both phases, the subjects have blood pressure data recorded by ambulatory blood~     pressure monitoring, for clinic and ambulatory analysis. In addition, continuously be~     registered biological signs of blood pressure (finometer), electrocardiogram (DII derivation)~     and blood flow (venous occlusion plethysmography) for analysis of cardiac autonomic~     modulation, vascular autonomic modulation, baroreflex sensitivity, vasodilator response and~     peripheral vascular resistance.~   "
68855|NCT02665676|"~     The aim of this study is to investigate demographic & disease characteristics of pediatric~     cancer patients diagnosed with one of embryonal tumors to identify the prevalence, the~     spectrum of these disease entities & treatment outcomes in these patients.~   "
68474|NCT02670668|"~     The study is to determine the prevalence of potential chemo-response related genes mutation~     in TNBC patients between pCR and SD/PD group, which achieved after NAC; and to evaluate~     potential relationship between these gene mutations and NAC-response in TNBC patients.Based~     on the results,we can further characterize TNBC from a phenotypical and molecular~     perspective, in order to identify potential new target agents and to individualize the~     treatment.~   "
68475|NCT02670655|"~     Iontophoresis is a transdermal drug-delivery technique that enhances the transport of ionic~     species across membranes and may have significant benefit for the treatment of actinic~     keratosis (AK) by ablative fractional laser-primed photodynamic therapy (AFL-PDT).~   "
68476|NCT02670642|"~     The purpose of this study is to compare on demand with continuous treatment of endoscopy~     negative subjects with gastroesophageal reflux disease (GERD), with esomeprazole 20-mg once~     daily, with regards to willingness to continue in the study as a result of satisfactory~     treatment over a six-month long term management period, after initial symptom relief.~   "
68477|NCT02670629|"~     This fractures have been managed with anatomical reduction performed under anesthesia or~     using sedatives. In our institution this means prolonged hospital stay, involvement of an~     anesthesiologist and the use of an special room in the Emergency Department. This research~     protocol was born after reports were published regarding leaving the fractures in an~     overriding position and cast with good functional and acceptable radiographical results; said~     study was observational, providing valuable but limited information about this treatment~     option. On the other hand, our study is a randomized controlled trial between to groups of~     patients younger than 11 years old who presented to the Emergency Department with completely~     displaced distal radius fractures, they were randomly assigned to one of two groups, either a~     closed anatomic reduction and short cast or a closed overriding alignment and short cast.~   "
68478|NCT02670616|"~     This study was conducted to evaluate the complete response rate of Ibrutinib + R-CHOP in~     patients with Epstein-Barr virus-positive diffuse large B-cell lymphoma.~   "
68479|NCT02670603|"~     This study is a prospective randomized controlled study of EVONAIL® solution for prevention~     or treatment of onycholysis in patients with breast cancer receiving docetaxel chemotherapy.~   "
68480|NCT02670590|"~     Investigators perform a counseling intervention study (6 months) in adult subjects with~     evidence of Fatty Liver by Ultrasound, graded 0-3 according to the Bright Liver Score (BLS);~     exclusion criteria are diabetes, renal insufficiency (glomerular filtration rate < 90~     ml/min), cancer, heart failure > II NYHA ( New York Heart Association) Class), chronic virus~     hepatitis, and cirrhosis. Insulin resistance was assessed as homeostasis model~     assessment-insulin resistance (HOMA-IR) . Suggestions and advice on individual healthy food~     purchase, storage, and cooking were given. Reliable feedback and evidence of patients'~     adherence were obtained by scheduled dietician's interviews. Investigators will challenge the~     predictive effects of the Adherence to Mediterranean Diet, of Western dietary profile score~     and of increased physical activity at 6 months in a body mass index changes-balanced model to~     detect independent effects, if any, of the studied variable on NAFLD persistence,~     amelioration or disappearance. Threshold and odds of Mediterranean and Western dietary~     profile score will be calculated by contingency tables and receiver operator characteristic~     curve (ROC) analysis..~   "
68481|NCT02670577|"~     The scope of this study is to measure the impact of MammaPrint on treatment in Hormone~     Receptor (HR)-positive HER2-negative breast cancer patients.~      In addition, the impact of MammaPrint on treatment in patients with T1a/T1b and pN0/pN1 (up~     to 1 node), Triple Negative or HER2-positive tumors will be assessed.~   "
68482|NCT02670564|"~     Pharmacogenomics (PG) offers the opportunity to individualize treatment according to patient~     genetic variations which influence activity of enzyme metabolizing or acting in the pathway~     of prescribed chemotherapy drugs.~      This add-on research aims to prospectively investigate variations in several candidate genes~     related to all types of chemotherapeutic drugs and TBI used in the main related study NCT~     01949129, THE ALL SCTped FORUM study for their potential role as predictive biomarkers of PK~     variability and outcome of myeloablative therapy for pediatric patients receiving an~     allogeneic hematopoietic stem cell transplantation in acute lymphoblastic leukemia.~   "
68483|NCT02670551|"~     This study investigates the efficacy of a fixed-dose regimen of cariprazine 1.5 mg/day or 3~     mg/day compared to placebo for treatment of the depressive episode in patients with bipolar I~     disorder. The safety and tolerability of the fixed-dose regimens will be evaluated.~   "
68484|NCT02670538|"~     This study is designed to prospectively confirm the efficacy of a fixed-dose regimen of~     cariprazine 1.5 mg/day or 3 mg/day compared to placebo for treatment of the depressive~     episode in patients with bipolar I disorder. The safety and tolerability of the fixed-dose~     regimens will be evaluated.~   "
68485|NCT02670525|"~     This research study is seeking to gain new knowledge about Recurrent, Refractory, or High~     Risk Leukemias in children and young adults.~      This study is evaluating the use of specialized testing called leukemia profiling. Once the~     profiling is performed, the results are evaluated by an expert panel of physicians,~     scientists and pharmacists. This may result in a recommendation for a specific cancer therapy~     or a clinical trial called matched targeted therapy (MTT). The results of the leukemia~     profiling and, if applicable, the MTT recommendation will be communicated to the~     participant's primary oncologist.~   "
68486|NCT02670512|"~     Compared to hemodialysis, patients on peritoneal dialysis live longer and healthier, have a~     higher quality of life and cost approximately $40,000 less to the healthcare system per~     patient per year. However, only 18% of dialysis patients in Canada currently use peritoneal~     dialysis because patients often feel isolated from the healthcare team and lack the~     confidence to manage treatments by themselves. This study will assess a telehome monitoring~     system (eQ Connect™), allowing for up-to-date data transmission and digital interaction~     between the patients at home and their healthcare team. From the patients' perspective, this~     technology is an easier way to communicate with their healthcare providers, track their~     treatment and supplies, and receive training and support. From the providers' perspective, eQ~     Connect™ delivers up-to-date patient data and provides an efficient way to keep track of the~     patients' progress. This intervention has the potential to improve the patients' clinical~     outcomes, quality of life, reduce the costs of dialysis to the healthcare system and~     ultimately empower patients to start and stay on peritoneal dialysis.~   "
68487|NCT02670499|"~     Post Market TKR study~   "
68488|NCT02670486|"~     Many women have the need to run to the restroom frequently during the night and day, a~     condition called overactive bladder. Embarrassing urinary leakage is also commonly~     associated with these symptoms. The investigators believe the primary cause in most cases is~     the bladder muscle contracting too frequently but are still not sure exactly why this happens~     and if it is triggered by factors in the environment. When bladder testing using pressure~     catheters (urodynamics) is done these bladder contractions are often not picked up, even in~     women with overactive bladder. This may be partly due to the unnatural environment in which~     the testing is done without the presence of the usual visual or audible triggers, such as~     running water or seeing a toilet. The investigators propose adding an audiovisual stimulant~     to the usual bladder testing to see if this makes it more likely for bladder contractions to~     happen. One group of patients would have the usual bladder testing as part of their normal~     care. The other group would receive the normal care in addition to hearing a water fountain~     in the room and watching a video of things that may trigger overactive bladder symptoms;~     seeing public restroom signs in a mall, a toilet bowl being lowered and a kitchen sink with~     water running over dishes. The suspicion is that the proportion of patients in whom bladder~     contractions are seen will be higher for those with audiovisual triggers compared to those~     with the usual care. Women with overactive bladder or leakage with urge who are sent for~     urodynamics by their doctor will be asked if they wish to participate in the study.~   "
68489|NCT02670473|"~     The aim of this dispensing study is to evaluate the clinical performance of habitual wearers~     of enfilcon A lenses following a refit with fanfilcon A lenses over 4 weeks of daily wear.~   "
68490|NCT02670460|"~     Study conducted to confirm phrenic nerve stimulation using the Lungpacer LIVE Catheter,~     confirm capture of the diaphragm and confirm that the diaphragm can be paced in synchrony~     with mechanical ventilator breaths.~   "
68491|NCT02670447|"~     Researchers propose in this project to evaluate predictive factors of non response. It is~     defined by the lack of symptomatic remission at month 3, for patients presenting a first~     episode of psychosis. It will be performed on objective markers taken from imagery~     techniques. The link between evolution of these markers and clinical measures will be~     studied.~   "
68492|NCT02670434|"~     The purpose of this study is to compare the efficacy of NK-104-CR with Placebo and Livalo® on~     the reduction of LDL-C and to evaluate the safety of NK-104-CR in patients with primary~     hyperlipidemia or mixed dyslipidemia~   "
68493|NCT02670421|"~     Will the intervention (Heart SMART program) be feasible in moderate or high stress patients,~     who are referred to the Women's Heart and Preventive Cardiology clinics at Mayo Clinic?~   "
68494|NCT02670408|"~     Demonstrate the impact of the Molecular Microscope Diagnostic System as the standard of care~     for heart transplant patients.~   "
68495|NCT02670395|"~     The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of~     JNJ-54416076 and any associated metabolite(s) (in Part 1) and safety, tolerability and PK of~     JNJ-54416076 when co administered with food compared to administration in fasting condition~     (in Part 2).~   "
68496|NCT02670382|"~     The objective of this study is to provide critical information regarding both common and~     distinctive roles of EPA and DHA in systemic inflammation and lipid metabolism.~   "
68497|NCT02670369|"~     The investigators are doing a study to learn how to support patients aged 60+ in taking more~     breaks from sitting. The goal of the study is to find out if using commercially available~     devices are helpful in reducing sitting time.~   "
68498|NCT02670356|"~     Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are omega-3 fatty acids found in~     fish oil and in krill oil. The purpose of this study is to compare the effects of the~     recommended dose of a fish oil supplement (Omax3 4:1 EPA:DHA; recommended daily dose 1650 mg~     - totaling 1500 mg EPA+DHA) and a krill oil supplement (MegaRed; recommended daily dose 300~     mg - totaling 74 mg EPA+DHA) on omega-3 index, plasma biomarkers of inflammation and~     inflammatory cell activation, and plasma lipid levels in subjects with metabolic syndrome.~   "
68499|NCT02670343|"~     An open-label, single oral TU dose study was conducted in eight (8) hypogonadal men at a~     single study site. Each study participant received a single oral TU dose immediately prior to~     a standardized breakfast meal comprised of 800 to 1000 calories and approximately 30 g of~     fat. Blood samples were collected 30 minutes prior dose administration and at 0 pre-dose and~     post dose at the following hours post-dose; 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours.~   "
68500|NCT02670330|"~     The aim is to assess the long-term safety of topical use of ZORBLISA in patients with~     Epidemolysis Bullosa.~   "
68501|NCT02670317|"~     This is a prospective, multicenter, single arm, phase II trial in young patients (18-60~     years) with poor-prognosis (aaIPI 2 or 3) newly diagnosed Diffuse Large B-cell Lymphoma~     (DLBCL).~      Aim of the study is to assess the efficacy and the safety of G-CHOP in combination with~     ibrutinib.~   "
68502|NCT02670304|"~     Letrozole is one kind of aromatase inhibitors which may have effect on decrease estrogen in~     luteal phase and inhibit the luteal function of ovary. In 2009, Letrozole was reported as one~     candidate for the treatment or prevention of ovarian hyperstimulation syndrome.~   "
68503|NCT02670291|"~     This randomized, sham-controlled, double blind, multicentre clinical trial aims at providing~     evidence for the efficacy and safety of continuous theta burst stimulation (cTBS) in the~     treatment of auditory hallucinations in patients with schizophrenia. Overall, the study will~     include 86 patients. Each patient will receive a three weeks course of daily (5/week)~     treatment; 50% of the patients will be treated with cTBS (1200 impulses daily), the other~     half with a sham stimulation to the left and right temporoparietal cortex. Sham stimulation~     will be applied by an active sham-coil that allows for a double-blind treatment. Follow-up~     assessments 1, 3 and 6 months after treatment will investigate the stability of treatment~     effects.~   "
68540|NCT02669810|"~     The main purpose of this phase I/IIB is to evaluate the safety, the tolerance and the first~     efficacy trends of intracardiac injection of ProtheraCytes (autologous PB-CD34+ Stem Cells~     after automated ex-vivo expansion with the StemXpand machine) in patients with a De Novo~     acute myocardial infarction and decreased ejection fraction. ProtheraCytes will be reinjected~     using a dedicated catheter pushed through the femoral artery up to the left ventricle, thus~     avoiding open chest surgery.~   "
68504|NCT02670278|"~     It is well-known that breastfeeding protects infants from illness, especially in the poorest~     regions of the world. The full nature of this protective effect, however, is less well~     understood. A major barrier to understanding is the fact that almost nothing is known about~     the factors that influence the considerable variation in milk composition around the globe,~     or about the effects of this variation on infant health. This INSPIRE project represents the~     first comprehensive investigation of the global differences in human milk composition along~     with the various microbial, evolutionary, environmental, and sociocultural factors that might~     influence both milk composition and infant health. An international, interdisciplinary~     collaboration of physiologists, nutritional scientists, anthropologists, microbiologists, and~     mathematicians will collect biological data from breastfeeding women and their infants, in~     concert with extensive anthropologic and ecological data, in both developed (US, Spain,~     Sweden) and developing countries (Central African Republic, Gambia, Ghana, Peru, and Kenya).~     To test the possibility of a correlation between milk oligosaccharide composition, milk~     microbiota, and the gastrointestinal microbiome of infants, milk samples and infant fecal~     samples will be analyzed using state-of-the-art biochemical and genomic techniques. This~     study will allow important cross-cultural comparisons of milk composition and infant feeding~     practices; it also will utilize sophisticated computational methods to integrate the~     extensive, diverse body of combined biological and anthropological data to elucidate the~     relationships among sociocultural factors, evolutionary history, environmental exposures,~     microbial constituents and milk composition. The researchers predict that what is considered~     normal milk composition in one population may not support optimal health in another. This~     information is crucial to the humanitarian quest to understand how infant nutrition and~     overall health can be improved around the world. In addition, this project will provide~     extensive research training opportunities for undergraduate, graduate and postdoctoral~     scientists.~   "
68505|NCT02670265|"~     Patients with biliopancreatic tumors are at risk for malnutrition and have to undergo many~     procedures for diagnostic workup that require fasting periods. In a prospective randomized~     monocentric study we evaluate the effect of additional parenteral nutrition on weight loss,~     nutritional status, quality of life and length of hospital stay.~   "
68506|NCT02670252|"~     Allogeneic hematopoietic stem cell transplantation (allo-HSCT) appears to be an efficient~     tool to cure standard-risk acute lymphocytic leukemia (ALL) in first CR (CR1) but the choice~     between BU-based or TBI-based conditioning regimens still remains controversial. In this~     study, the safety and efficacy of BUCY and TBICY myeloablative conditioning regimens in~     patients undergoing allo-HSCT for ALL in CR1 are evaluated.~   "
68507|NCT02670239|"~     Ex vivo lung perfusion (EVLP) is an established strategy to evaluate and optimize high-risk~     donor lungs that would otherwise be rejected for transplantation mainly due to the presence~     of edema or infection. Extracorporeal circuits may negatively affects pharmacokinetic (PK) of~     several drugs including antibiotics, thus exposing patients to risk of therapeutic failure or~     drug toxicity. The investigators set out to examine the concentration of imipenem in lung~     perfusate and in lung biopsy during EVLP, and its clinical impact.~   "
68508|NCT02670226|"~     The first objective is to find some biomarkers, or a profile of biomarkers of ALS to help to~     diagnosis. The second objective is to better understand the pathogenesis of this disease by~     the exploration of muscle, blood and satellite cells metabolomes and transcriptomes.~   "
68509|NCT02670213|"~     This study is conducted in Asia. Tha aim of this study is to investigate Safety and~     Effectiveness of NovoThirteen® (rFXIII) during treatment of congenital FXIII deficiency in~     Japan.~   "
68510|NCT02670200|"~     Cancer patients develop a high psychological burden of the underlying disease. To support~     patients in outpatient phases psychotherapists are not sufficiently available for establish~     regularly face-to-face-contact. The availability of Internet-based psychotherapeutic support~     can bridge this gap. This study examines the effectiveness of MAC-CBT® via the Internet~     (called Incobeth®) in cancer patients.~   "
68511|NCT02670187|"~     The Middle East Respiratory Syndrome Coronavirus (MERS CoV), a virus related to Severe Acute~     respiratory syndrome coronavirus (SARS CoV), was first recognized as a cause of severe~     pulmonary infection in 2012. Infection with MERS CoV has been diagnosed in more than 1600~     individuals with a mortality rate between 35% and 40%. GLS-5300 is a DNA plasmid vaccine that~     expresses the MERS CoV spike (S) glycoprotein. This study will evaluate the safety of~     GLS-5300 at one of three dose levels following a three-injection vaccination regimen followed~     by electroporation. The study will also assess immune responses over a 1 year period with~     respect to the generation of antibody and cellular responses.~   "
68512|NCT02670174|"~     A randomized controlled trial will be conducted to examine the effectiveness of a traditional~     home exercise program versus 2 kinetic chain home exercise programs on treatment outcome of~     overhead athletes with shoulder impingement syndrome. Primary outcome measures are reduction~     of pain and disability, and improvement in functionality and sports performance. Secondary~     outcome measures are strength, mobility, flexibility and functional performance.~   "
68513|NCT02670161|"~     The investigators will conduct at NorthShore University HealthSystem pragmatic trials using~     the EMR for 10 common neurological disorders. They will demonstrate the feasibility of~     subgroup based adaptive assignment of treatments, electronic consenting, and outcomes data~     capture at the point of care using the EMR. They will identify the most effective treatments~     for common neurological disorders and seek replication by the NPBRN.~   "
68514|NCT02670148|"~     This study is a randomized controlled trial designed to compare the effects of 4 weeks of~     chiropractic care to a waitlist control group on measures of strength, balance, and endurance~     in military personnel experiencing non-surgical low back pain.~   "
68515|NCT02670135|"~     This is a single center, double blinded, randomized, controlled trial. Qualified subjects~     will be enrolled and randomized to either one of the two study groups: a) using 0.3%~     triclosan/copolymer/fluoride dentifrice twice daily - b) using a matching control dentifrice~     (copolymer/fluoride/no triclosan) twice daily.~   "
68516|NCT02670122|"~     This is an observational, multicenter, single arm, prospective study to evaluate safety and~     tolerability of selective and ultraselective drug eluting beads transcatheter intraarterial~     chemoembolization (DEB-TACE) with up to 3 ml of well calibrated 100 µ microspheres and up to~     150 mg of doxorubicin, for the treatment of non resectable hepatocellular carcinoma (HCC).~      The hypothesis is that 100 µ beads penetrate deeper into the tumor than those eluting beads~     with larger volumes without increasing the risk and complications of DEB-TACE.~   "
68555|NCT02669615|"~     This study is a single-center, open-label study of high-dose Melphalan HCl for injection~     (propylene glycol free Melphalan) conducted in 24 patients, who have symptomatic multiple~     myeloma and qualify for ASCT.~      There will be three distinct evaluation periods in this trial: a pretreatment period, a study~     period and a follow-up period.~   "
68556|NCT02669602|"~     Dynamic prospective cohort of Spanish university graduates. The main objective is to evaluate~     the associations between nutrition and lifestyle and chronic diseases.~   "
68517|NCT02670109|"~     Triple-negative breast cancer (TNBC) refers to any breast cancer that does not express~     estrogen receptor (ER), progesterone receptor (PR) or Her2/neu. Its incidence is~     approximately 180,000 cases per year. TNBC are known to be more aggressive with poor~     prognosis specially when no pathologic complete response (pCR) is achieved after neoadjuvant~     chemotherapy, with a higher risk of recurrence and a poor survival once that recurrence~     occurs. On the other hand, there is not a specific adjuvant or neoadjuvant treatment for~     these patients. Since autologous hematopoietic stem cell transplantation (HSCT) allows the~     usage of higher doses of chemotherapy, which results in higher cellular destruction with a~     decrease of hematological toxicity, it is proposed that this procedure is able to improve~     prognosis in TNBC patients with no pathologic complete response after neoadjuvant~     chemotherapy.~   "
68518|NCT02670096|"~     This is a single center pilot study evaluating the immediate effects of low-dose~     acetazolamide on respiratory control in subjects with treatment emergent sleep disordered~     breathing. The purpose of this study is to assess the immediate effect one-time low-dose~     acetazolamide on sleep breathing in (Treatment Emergent Sleep Disordered Breathing) TE-CSA~     subjects compared to subjects' baseline evaluation without acetazolamide. Investigators will~     also try to determine the immediate effect of one-time low-dose acetazolamide on subjects'~     resting ventilation and ventilatory response slope compared to subjects' baseline evaluation~     without acetazolamide.~   "
68519|NCT02670083|"~     This randomized, double-blind, placebo-controlled, parallel group study will evaluate the~     efficacy and safety of crenezumab versus placebo in participants with prodromal to mild AD.~     Participants will be randomized 1:1 to receive either intravenous (IV) infusion of crenezumab~     or placebo every 4 weeks (q4w) for 100 weeks. The final efficacy and safety assessment will~     be performed 52 weeks after the last crenezumab dose.~   "
68520|NCT02670070|"~     This study is to evaluate the safety/tolerability and pharmacokinetics of the combinations of~     gemigliptin 50mg and rosuvastatin 20mg in comparison to each component administered alone in~     healthy male volunteers.~   "
68521|NCT02670057|"~     The purpose of this open label pilot study is to evaluate the utility of sphenopalatine~     ganglion (SPG) block to manage ipsilateral shoulder pain (ISP) during and/or after cesarean.~   "
68522|NCT02670044|"~     The primary objective for this study is to assess the safety and tolerability as well as~     preliminary efficacy of venetoclax in combination with cobimetinib, and venetoclax in~     combination with idasanutlin in patients >/= 60 years of age with relapsed or refractory~     acute myeloid leukemia (R/R) AML who are not eligible for cytotoxic therapy.~   "
68523|NCT02670031|"~     Hypertension and aortic stenosis are the two leading conditions that cause thickening of the~     heart muscles (left ventricular hypertrophy). Left ventricular hypertrophy is initially~     adaptive to maintain optimal heart function. Ultimately, heart failure occurs as a result of~     progressive muscle cell death and scarring (myocardial fibrosis). Dedicated techniques using~     cardiovascular magnetic resonance imaging (MRI) and novel high-sensitivity cardiac troponin~     blood assays are potential markers to detect myocardial fibrosis. Although~     hypertension-related heart disease is very common in Singapore, the significance of~     myocardial fibrosis is not well understood. In this study, the significance of myocardial~     fibrosis in 500 patients with hypertension would be investigated. This will be the largest~     study using state-of-the-art MRI to examine the importance of myocardial fibrosis in~     hypertensive heart disease.~   "
68524|NCT02670018|"~     A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the~     Pharmacokinetics and Safety/Tolerability of the Combination of Gemigliptin/Metformin HCl~     Sustained Release 50/2000 mg(25/1000 mg x 2 tablets) in Comparison to Each Component~     Gemigliptin 50 mg and Metformin HCl Extended Release 2000 mg (1000 mg x 2 tablets)~     Administered in Healthy Male Volunteers.~   "
68525|NCT02670005|"~     To assess the outcomes of patients with ST-segment elevation myocardial infarction (STEMI)~     assigned to fractional flow reserve (FFR) and angiography-guided selective percutaneous~     coronary intervention (PCI).~   "
68526|NCT02669992|"~     There are severel problems associated with the closing of a temporary loop-ileostomy after~     surgery for rectal cancer. The purpose of this study is to answer two questions:~        1. The choice of anastomotic method - does it influence the postoperative course?~        2. The use of a prophylactic mesh when closing the stoma site - will there be less hernias?~   "
68527|NCT02669979|"~     Today's increase of dentate elderly, many of them dependent, is a challenge, both according~     to the personal daily oral hygiene and dentistry. This is not only an oral problem, as~     research findings point to strong associations between oral and general health, even~     mortality. These findings are especially noticeable in elderly and frail individuals.~      Dental care is usually performed in stationary dental clinics where the patients are~     transported to receive treatment. Dependent elderly dental patients may present many~     obstacles to traditional dental care due to cognitive limitations or dementia, mobility or~     transport problems. An alternative is domiciliary dental care where the dental staff performs~     the treatment by a home visit, in the patients daily living environment. The ability to~     handle personal oral hygiene is often decreased in these patients and left to overburdened~     nursing staff that often also lack sufficient knowledge about oral health care, why~     prophylactic professional oral care is especially important. This type of care can with~     rather simple equipments be performed as domiciliary treatment of good quality, while more~     advanced dental care may present restrictions in the home environment. However, in the~     Swedish dental system with subsidized dental care for dependent and elderly patients, there~     are restrictions for the number of prophylactic oral care treatments. The levels vary in~     different counties and regions. The rationale for this is probably tradition and economy as~     scientific evidence is lacking.~      The aim with this project is to develop domiciliary professional oral care. The researchers~     will compare the effect of different regimens for domiciliary prophylactic professional oral~     care both according to content and frequency. The overall aim is to establish relevant~     recommendations for domiciliary prophylactic professional oral care.~   "
68528|NCT02669966|"~     It is well recognized that a subset of patients who contracts Hepatitis C virus (HCV)~     spontaneously clears the virus. Such individuals are anti-HCV antibody positive, yet HCV RNA~     PCR negative in the blood. While they have not been considered candidates for live kidney~     donation in the past, with the recent availability of novel anti-HCV drugs with >95% cure~     rates, they now represent a potential pool of donor candidates, especially since the risk for~     transmission of HCV to the recipient is extremely low. The investigators goal is to~     demonstrate that live kidney donation from anti-HCV positive, HCV RNA PCR negative~     individuals is safe and carries a negligible risk of viral transmission to the recipient.~   "
68557|NCT02669589|"~     The aim of this study is to evaluate the effect of regional citrate anticoagulation within~     the scope of continuous renal replacement (CRRT) in critically ill patients with acute kidney~     injury (AKI) on filter life span and 90-day all cause mortality.~   "
68558|NCT02669576|"~     This randomized controlled trial aims to investigate the effectiveness of a mind body day~     care clinic program of breast cancer patients undergoing endocrine therapy.~   "
68529|NCT02669953|"~     Age-related macular degeneration (AMD) and diabetic retinopathy are among the most common~     disorders causing visual disability in elderly people. AMD leads to dysfunction and loss of~     photoreceptors in the central retina. Neovascular AMD (nAMD) affects visual function early in~     the disease process.~      The purpose of the study is to evaluate the effect of switching from ranibizumab therapy to~     the current routine therapy using aflibercept in eyes with treatment naive, recurrent or~     persistent nAMD, treatment naive diabetic retinopathy and pretreated diabetic retinopathy.~      20 patients with recurrent or persistent nAMD, previously treated with intravitreal~     ranibizumab for up to one year will be included in this trial. Patients will be examined in~     monthly intervals over 12 months follow-up.~      Examinations carried out will include: Best-corrected visual acuity (BCVA) using ETDRS charts~     at 4m distance, Reading Performance (RP), Standard ophthalmic examinations (SOE incl.~     funduscopy and applanation tonometry), Optical coherence tomography (OCT), Autofluorescence~     fundus image (AF) & red-free autofluorescence fundus image (RF), Color fundus photography~     (CFP), Fluorescein angiography and indocyaningreen angiography (FLA/ICG), Microperimetry~     (MP), as well as Non-invasive OCT based optical angiography (AngioVue).~   "
68530|NCT02669940|"~     This study seeks to assess the effectiveness, patient reported outcomes, work productivity~     and healthcare resource utilization of the interferon-free regimen of Paritaprevir~     (PTV)/ritonavir (r) - Ombitasvir (OBV), ± Dasabuvir (DSV), ± Ribavirin in chronic hepatitis C~     (CHC) participants in a real life setting across clinical practice populations.~   "
68531|NCT02669927|"~     To find an objective, affordable and manageable way to measure frailty in elderly patients~     and to examine relationship between peri-operative metabolism of frail older people and~     outcome after hip surgery.~   "
68532|NCT02669914|"~     Brain metastases are the most common intracranial malignancy occurring in 20-40% of all~     cancers, and the presence of CNS metastases is associated with a poor prognosis. As such, the~     median overall survival of patients with symptomatic brain lesions is a dismal 2-3 months~     regardless of tumor type. Because standard chemotherapy largely does not cross the blood~     brain barrier at a meaningful concentration, standard treatment is limited and usually~     involves surgical resection and/or stereotactic radiosurgery for isolated lesions and whole~     brain radiation for multiple lesions. Unfortunately, the median overall survival is only~     improved by about 6 months with this multimodality approach2, and there is a paucity of~     second-line therapies to treat recurrence. Furthermore, re-resection and re-radiation are~     often not feasible options due to concern for increasing complications or neurotoxicity,~     respectively. Thus, there is a dire clinical need for additional treatment options for this~     patient population.~      Checkpoint blockade therapy, in particular PD-1 and PD-L1 inhibition, has recently shown~     clinical efficacy in multiple types of solid tumors. The investigators propose to study the~     efficacy of checkpoint blockade therapy in patients with solid tumors and~     refractory/recurrent brain metastases. The investigators will assess the efficacy of~     MEDI4736, a novel PD-L1 inhibitory monoclonal antibody, in this study.~   "
68533|NCT02669901|"~     The purpose of this pilot-study is to to distribute naloxone auto-injector in a Universal~     Precaution manner to patients with opioid substance use disorder. The objectives are to~     decrease the number of fatal and nonfatal overdose deaths, to examine and understand the risk~     factors for serious opioid toxicity and overdose, and to evaluate the unintentional opioid~     overdose risk utilizing an evidence-based screening questionnaire.~   "
68534|NCT02669888|"~     Atopic dermatitis (AD) is a chronic inflammatory skin disorder that most commonly occurs in~     children. The aims of this project are:~        1. To evaluate the efficacy of indigo naturalis ointment in treating AD topically;~        2. To evaluate the safety of indigo naturalis ointment in treating AD topically;~        3. To investigate whether indigo naturalis ointment treatment is associated with a change~          in total IgE, cytokines, eosinophils, and CRP in patients with AD;~        4. To evaluate whether indigo naturalis ointment treatment improves the quality of life in~          patients with AD.~   "
68535|NCT02669875|"~     Portal hypertension (an increase in blood pressure in the portal vein that carries the blood~     from the intestine and spleen to the liver) underlies most of the serious complications of~     liver cirrhosis. This randomised placebo controlled study in people with liver cirrhosis~     evaluates the acute effects serelaxin (RLX030) infusion on portal hypertension and liver~     blood flow.~   "
68536|NCT02669862|"~     This is a randomized, double-blind, vehicle-controlled, parallel-group study with 3 treatment~     groups.~   "
68537|NCT02669849|"~     The purpose of this study is to determine the efficacy and safety of VX-210 in subjects with~     Acute Traumatic Cervical Spinal Cord Injury. Secondary objectives include the specific~     evaluation of the effects of VX-210 on neurological recovery and daily function after spinal~     cord injury.~   "
68538|NCT02669836|"~     The purpose of this study is to determine whether a posterior fossa decompression or a~     posterior fossa decompression with duraplasty results in better patient outcomes with fewer~     complications and improved quality of life in those who have Chiari malformation type I and~     syringomyelia.~   "
68539|NCT02669823|"~     Severe malaria and bacterial Blood Stream Infections (bBSI) are impossible to differentiate~     clinically. This poses a particular threat in low resource areas, where bBSI is often not~     diagnosed due to the unavailability of rapid diagnostic means. Even if used appropriately,~     the sensitivity of blood culture to diagnose bBSI is estimated to be around 50%. To counter~     the high mortality rate associated with bBSI, antibiotics are often prescribed without~     microbiological confirmation. Sysmex Company has developed technology that enables the rapid~     diagnosis of malaria using a venous blood sample. In addition algorithms based on~     hematological parameters can be used to monitor disease severity and progression, as well as~     guide further diagnostic testing based on differences seen in these parameters between~     various types of disease. The algorithms have been developed and tested in adult populations~     from different industrialized countries and in one Asian population. However no data are~     available neither from pediatric patients, nor from the sub-Saharan setting where the~     epidemiology of infectious diseases is very different from the tested settings. The objective~     of the study is to: 1) Assess the sensitivity and specificity of the Sysmex hematology~     analyzer based on the new technology to diagnose malaria in subjects older than 3 months, who~     present with an acute severe febrile illness in a malaria endemic area in sub-Saharan Africa~     2) Test and optimize the value of Sysmex analyzers in disease diagnosis and monitoring in~     children older than 5 years and adults, who present with an acute severe febrile illness in a~     malaria endemic region in sub-Saharan Africa, to differentiate between severe malaria and~     bBSI, or a combination of these infections. 3) Explore the value of Sysmex analyzers in~     disease diagnosis and monitoring in children between 3 months and 5 years of age, who present~     with an acute severe febrile illness in a malaria endemic region in sub-Saharan Africa.~   "
68596|NCT02669082|"~     This study will explore the effect of ramelteon 8 mg once daily for 8 weeks for the treatment~     of insomnia patients with depression by using actigraphy.~   "
68597|NCT02669069|"~     This is a three arm, patient subtyping and parameter optimisation study for a neuromodulation~     treatment for tinnitus.~   "
68541|NCT02669797|"~     The proposed Family Matters study is an 18-month, individual randomized controlled~     superiority trial (RCT) aiming to decrease childhood obesity in children ages 5-7 years old~     by increasing family meal quality (i.e., dietary intake, emotional atmosphere) and quantity~     (i.e., frequency of family meals) via innovative technology (i.e., ecological momentary~     intervention (EMI), video feedback). The RCT is a three-arm superiority trial including the~     following three arms: (1) Education (Edu)+EMI; (2) Edu+EMI+Video feedback; and (3) Attention~     Control. Delivery of the intervention will last 12 months for each family, which includes a~     12-week maintenance phase. The study will last 18 months, with four assessment time points~     including, baseline, 9 months, 12 months (i.e., post-intervention), and 18 months (i.e.,~     6-month post-intervention).~   "
68542|NCT02669784|"~     Any adult patient age18 and above, scheduled for routine CTA of the chest or chest, abdomen~     and pelvis meeting inclusion criteria and not meeting any exclusion criteria will be included~     in the study. The patient will be administered a low dose of intravenous contrast based on~     the study examination.~   "
68543|NCT02669771|"~     The purpose of this study is to confirm the long term safety and efficacy of enzalutamide in~     patients.~   "
68544|NCT02669758|"~     The primary objective of this study is to evaluate the long term safety and tolerability of~     ALKS 3831 in subjects with schizophrenia.~   "
68545|NCT02669745|"~     This study is experimental and will prospectively assess the proportion of patients in the~     two (2) MammaPrint Risk categories in patients of Chinese descent.~   "
68546|NCT02669732|"~     The objective of the study is to evaluate change in insulin secretory capacity in patients~     with type 2 diabetes mellitus as determined by hyperglycemic clamp after a 28-day oral~     administration of DS-8500a at 75 mg in a placebo-controlled, 2 × 2 crossover study. In~     addition, safety of this regimen will be examined in this study.~   "
68547|NCT02669719|"~     This is a randomized, open-label, phaseⅡ study evaluating efficacy and safety of DC~     (dendritic cells) vaccine concurrent with chemotherapy compared to chemotherapy alone in~     patients with stage IV NSCLC (non small cell lung cancer) with wild-type EGFR (epidermal~     growth factor receptor).~   "
68548|NCT02669706|"~     The main objective of this study is to assess the safety of administering intravenous (IV)~     pentamidine for Pneumocystis jirovecii pneumonia (PJP) prophylaxis in adult inpatients with~     hematologic malignancies and stem cell transplant recipients. There will also be an~     assessment of patient satisfaction associated with intravenous pentamidine PJP prophylactic~     therapy.~   "
68549|NCT02669693|"~     This research is aimed at determining whether the presence of oleuropein in olives (Olea~     europaea L.) has any lowering effect on post-prandial blood glucose levels. Volunteers will~     be required to consume commercially available olives together with white bread, and their~     glycaemic response will be measured. The blood glucose response of bread will be determined~     initially as a control/reference. Food samples and control will be consumed in random order.~      The recent rise in the cases of Diabetes mellitus in both children and adults has raised a~     concern for the need to proffer immediate solutions amongst scientists in the fields of~     medicine food science and nutrition. One of the approaches of reducing postprandial~     hyperglycaemia and high glucose spikes is to impede digestion and absorption of starch. This~     is potentially achieved through the inhibition of the activities of starch digesting enzymes~     namely alpha amylase and alpha glycosidase. There are currently some antidiabetic drugs such~     as acarbose and miglitol which have been quite efficient in these inhibitory functions but~     not without associated side effects and complications such as liver toxicity, etc, arising~     from to long term usage of such drugs. It therefore becomes imperative for natural~     substitutes from food sources to be explored as better alternatives. At the moment several~     plant foods are under investigation as suitable alternatives, and olives appear to be quite~     promising in this regard. There are quite a few studies that have reported the inhibitory~     activities of olives oleuropein on alpha amylase in vitro but information on in vivo testing~     is very scarce.~      It is expected that the research outcome will be a gateway to the reduction and control of~     the incidence of diabetes mellitus.~   "
68550|NCT02669680|"~     Multicentre, open, randomised, and controlled trial conducted in patients diagnosed with~     acute on chronic liver failure (ACLF) who meet inclusion/exclusion criteria.The objective of~     GRAFT-trial is to evaluate efficacy and safety of subcutaneously administered granulocyte~     colony-stimulating factor (G-CSF) in patients with ACLF. All patients will receive standard~     medical care for ACLF according to the guidelines. Patients in the experimental arm~     additional receive subcutaneous injections of G-CSF.~   "
68551|NCT02669667|"~     This is a phase 1a randomized, blinded, placebo-controlled, single-ascending dose study to~     assess the safety and tolerability of MEDI9314 in healthy adult subjects~   "
68552|NCT02669654|"~     Background: At present pneumonia and malnutrition have become the leading causes of mortality~     among <5-year-old children in developing countries. World Health Organization standard~     management of severe pneumonia and severe malnutrition requires hospitalization for~     supportive care. As many developing countries including Bangladesh do not have enough~     pediatric hospital beds to accommodate the demand for admission of all children with severe~     pneumonia and malnutrition, Investigators developed alternative treatment option such as Day~     Care Approach, for those children who cannot be hospitalized, but are too sick to be managed~     in the community. After successful Day Care Approach of management of efficacy trials with~     severe childhood pneumonia and severe malnutrition, the next step is to conduct an~     effectiveness trial under real life condition, i.e. within the Health Systems of~     Bangladesh.~      Burden: Pneumonia is the leading cause of mortality in developing countries, being~     responsible for 1,368,000 (18%) of annual 7.6 million deaths, 95% occurring in developing~     countries. Similarly, malnutrition is a major health problem with an estimated 1.7 & 3.6~     million children dying annually because of Severe Acute Malnutrition & Moderate Acute~     Malnutrition, respectively.~      Objectives: To assess & implement the Day Care Approach of management of severe childhood~     pneumonia with or without Moderate Acute Malnutrition and/or severe underweight into existing~     Health Systems of Bangladesh as a safe & cost effective alternative to Existing Treatment.~      Methods: A cluster randomized controlled trial will be conducted in Bangladesh by involving~     16 clusters (Wards) in Dhaka & 16 clusters (Unions) in rural areas that will be randomly~     assigned to intervention & control arm. Children with severe pneumonia will be enrolled in~     (i) Tikatuli, (ii) Circular Road, (iii) Dhamrai Upazilla of Dhaka, (iv) Karimganj Upazillas~     to one of two management schemes: (i) Existing Treatment in control clusters or (ii) Day care~     Approach in intervention clusters by involving Comprehensive Reproductive Health Centres in~     urban and Health and Family Welfare Centres in rural areas.~      Outcome variables:~        -  Primary: clinical treatment failure by day 6~        -  Secondary:~           (i) Treatment failure between day 7-14 in children who are well on day 6 (ii) Cost~          effectiveness (iii) Referrals to hospitals (iv) Deaths~   "
68553|NCT02669641|"~     The main objective is the assessment of MRI (Magnetic Resonance Imaging) Spectroscopy in~     patients diagnosed with hepatic steatosis in treatment with combination Silimarin,~     Phyllanthus Niruri and Choline.~   "
68554|NCT02669628|"~     The purpose of this multicenter study is to evaluate the ovarian reserve after alcohol~     sclerotherapy of endometriomas versus conventional surgery.~   "
68559|NCT02669563|"~     The main goal of this study is to test two new radioactive drugs,~     4-[18F]fluoro-meta-hydroxyphenethylguanidine ([18F]4F-MHPG) and~     3-[18F]fluoro-para-hydroxyphenethylguanidine ([18F]3F-PHPG) in human subjects with congestive~     heart failure.~      Evaluations of these imaging agents will include their uptake in heart, lungs and liver,~     their metabolic breakdown in blood, and their kinetics in the heart. Based on these studies,~     the better of the two drugs will be chosen for further studies in patients with heart~     disease. After the better compound is chosen, additional measures of its imaging properties,~     metabolism and pharmacokinetics will be done in subjects with heart failure.~   "
68560|NCT02669550|"~     The fiberoptic bronchoscope (FOB) has been the preferred instrument for many years in the~     management of difficult tracheal intubation, and it is considered as a gold standard. The~     disposcope endoscope (DE) is a medical device for endotracheal intubation used in clinical~     practice recently.This study compares FOB and DE for awake orotracheal intubation in obese~     patients with anticipated difficult airway.~   "
68561|NCT02669537|"~     Utilization of the GoPro camera to facilitate vaginal surgical education among residents and~     medical students~   "
68562|NCT02669524|"~     In patients with type 2 diabetes, the incretin effect is markedly reduced contributing to the~     relative insulin deficiency that characterizes these patients. This defect is believed to be~     due to a decreased effect of GLP-1 and an almost ceased effect of GIP. Nevertheless, the~     impact of the defect on glucose tolerance is not fully understood. The so-called~     gastrointestinal-mediated glucose disposal (GIGD) is a measure of glucose handling, which~     includes the incretin effect, but also other factors affecting glucose disposal (e.g.~     glucagon secretion). Interestingly, patients with type 2 diabetes exhibit elevated plasma~     glucagon levels in the fasting state, and glucagon concentrations fail to decrease~     appropriately and may even increase in response to ingestion of glucose and show exaggerated~     increases after a mixed meal. With the current project the investigators wish to elucidate~     how this paradoxical glucagon response observed in patients with type 2 diabetes affects the~     GIGD, the incretin effect and postprandial glucose excursions.~      Ten patients with type 2 diabetes and 10 healthy matched control subjects will be enrolled in~     this randomised, placebo-controlled, double-blinded study. The aim is to examine the effect~     of a glucagon receptor antagonist (GRA) on gastrointestinal-mediated glucose disposal (GIGD),~     incretin effect and postprandial glucose excursions in patients with type 2 diabetes and~     healthy controls. Participants will attend two oral glucose tolerance tests (OGTT), two~     isoglycaemic iv glucose infusion (IIGI) and two standardised liquid meals.~   "
68563|NCT02669511|"~     An open-label, non-randomized, two-stage, multicenter study evaluating clinical efficacy,~     safety and pharmacokinetics of PQR309 in patients with relapsed or refractory Primary Central~     Nervous System Lymphoma (PCNSL).~   "
68564|NCT02669498|"~     Two recently published articles need to be cited to explain the rationale for our study since~     both studies conclude with contrary findings: The first one is The post-reproductive~     Fallopian tube: better removed? and the other is termed Factors associated with age of~     onset and type of menopause in a cohort of UK women.~      In essence, while Dietl et al suggest to remove the Fallopian tube routinely in every~     hysterectomy and every sterilization procedure after 35 yrs of age, Pokoradi et al showed~     that pelvic surgical procedures and even simple tubal sterilization are associated with an~     earlier menopause. Hence, this is an important issue as early menopause leads to adverse~     health status.~   "
68565|NCT02669485|"~     The aim of this study was to evaluate the impact of fluorescence imaging on the location of~     colorectal transection lines based on evaluation of perfusion with indocyanine green, how~     it's going to affect surgical planning and its possible benefits in reducing anastomotic~     leakage.~   "
68566|NCT02669472|"~     Live Well, Viva Bien (LWVB) is an NCI-funded, cluster randomized controlled trial (RCT) that~     was conducted in 15 subsidized housing complexes to evaluate the efficacy of a multicomponent~     intervention comprised of a year-round, discount, mobile fresh F&V market -'Fresh To You'~     (FTY)- that was paired with a nutrition education component including included educational~     newsletters, campaigns, taste-testings and videos in both English and Spanish. The primary~     aim of the LWVB grant was to study the efficacy of FTY combined with a~     motivational/educational intervention to see if it increased F&V consumption compared to a~     Comparison intervention (attention placebo).~   "
68567|NCT02669459|"~     The purpose of this study is to investigate if imiquimod can be used as a non-invasive option~     in the treatment of residual/recurrent CIN lesions.~   "
68568|NCT02669446|"~     This a comparative, open label, parallel group, non interventional study which compares the~     tolerability and influence of Ectoin containing Lozenges to saline solution and lozenges~     containing hyaluronic acid for the treatment of acute viral Pharyngitis. The observation~     takes place over a period of 7 days. Response to treatment is recorded at day 1 and day 7 by~     the physician and by the patient in a dairy.~   "
68569|NCT02669433|"~     This study seeks to evaluate the efficacy and safety of intepirdine (RVT-101) in patients~     with dementia with Lewy bodies.~   "
68570|NCT02669420|"~     The majority of second-trimester pregnancy termination performed in the United States are~     performed surgically by dilation and evacuation. The frequency of induction of abortion~     increases as gestational age advances. In the late second trimester and early third~     trimester, induction is the primary method of termination in cases of fetal abnormalities. In~     many other countries, however, induction is the primary method of abortion throughout the~     second trimester~   "
68571|NCT02669407|"~     Patients admitted for acute heart failure and undergoing right heart catheterization will be~     enrolled in this study. Subjects will undergo catheterization of the heart to obtain central~     cardiac pressure and other cardiac hemodynamic parameters. Subsequently, the subject will~     undergo a regional nerve block of the splanchnic nerves. Patients will remain in the~     catheterization lab for the duration of anesthetic block and will be continuously~     hemodynamically monitored.~      This study will be a prospective, uncontrolled clinical trial. The study will not be~     controlled as invasive monitoring of hemodynamics will be performed, allowing clear~     demonstration of a cause-effect relationship. The goal of the study is to provide proof of~     concept.~   "
68572|NCT02669394|"~     The investigators will conduct a proof-of-concept randomized controlled trial study to~     provide preliminary evidence of efficacy of a resistance exercise training program for~     maintaining white matter integrity and improving cognitive function in older adults with~     vascular cognitive impairment, compared with a stretch and relaxation program.~   "
68573|NCT02669381|"~     Phenylalanine is an essential amino acid that people need to obtain in their diets. Amino~     acids are the building blocks for protein, which is required to form tissues in the body. It~     is well known that pregnant women require more protein in their diets, but the exact amount~     for each amino acid is undetermined. To find out how much of phenylalanine pregnant women~     require, the investigators plan to study pregnant women in early and late gestation with a~     modern minimally invasive technique.~   "
68574|NCT02669368|"~     This study aims to evaluate effects of magnesium sulfate on onset and duration of low dose~     rocuronium, intubation condition and surgical condition in patients undergoing laparoscopic~     cholecystectomy.~   "
68575|NCT02669355|"~     Doctor's attire acts as an important criteria in setting up good relationship between patient~     and physician. Recent evidence as well as strong viewpoints have highlighted the possible~     harm of wearing a white coat. In order to get the patient's perspective on the same, this~     observational study is being conducted to determine the effect of wearing a white coat on~     patient satisfaction in an Indian setting , in patients who visit rheumatology outpatient~     department,in Columbia Asia Hospitals,Bangalore,India.~   "
68576|NCT02669342|"~     The aim of this study is to determine if the Sharklet catheter, with its unique coating,~     reduces infections in participants, when compared to a standard catheter.~   "
68577|NCT02669329|"~     Evaluate the safety and efficacy of the ZELTIQ CoolSculpting System using a specialized~     surface applicator for non-invasive subcutaneous fat reduction in the upper arm.~   "
68578|NCT02669316|"~     NAFLD is associated with unhealthy lifestyle and obesity, without alcohol habits. An~     association of NAFLD with coronary artery disease and with impaired heart function was~     reported, but without considering severity of NAFLD and with the bias of including diabetes.~     Aim: to challenge if severity of liver steatosis assessed by UltraSound Bright Liver Score~     (BLS) can predict the impairment of systolic heart function, assessed by echocardiography~     (Ejection Fraction, EF), diastolic function (assessed by E/A ratio), Left Ventricular Mass,~     Left atrial diameter.~   "
68579|NCT02669303|"~     The purpose of this study is to determine whether injection of platelet-rich plasma derived~     from patient's blood is effective in treatment of shoulder subacromial impingement syndrome~     as compared to the current protocol of methylprednisolone injection.~   "
68580|NCT02669290|"~     The purpose of this study is to determine whether multiple gated acquisition (MUGA) guided~     lead placement improves clinical outcomes for patients needing cardiac resynchronization~     therapy (CRT) compared to traditional posterolateral left ventricular lead placement.~   "
68581|NCT02669277|"~     To demonstrate the efficacy of new product IVIG prepared by minipool technology as assessed~     by Bleeding Score and platelet count at 3 days, 1 week, 2 weeks and 4 weeks.~      The platelet response rate is defined as the percentage of subjects responding to treatment~     with an increase of platelet count from ≤ 20 x 10^9/L to ≥ 100 x 10^9/L and absence of~     bleeding (complete response) or platelet count ≥ 50 x 10^9/L and at least 2-fold increase the~     base line count with absence of bleeding (partial response), within the specified time frame.~   "
68582|NCT02669264|"~     This study evaluates ADCT-402 in patients with relapsed or refractory B-cell lineage acute~     lymphoblastic leukemia (B-ALL). Patients will participate in a dose-escalation phase (Part 1)~     and dose expansion (Part 2). In Part 2, patients will receive the dose level identified in~     Part 1.~   "
68583|NCT02669251|"~     Background:~      Bronchiolitis obliterans syndrome (BOS) is a complication people can experience after~     hematopoietic stem cell transplant. It usually affects people with chronic graft versus host~     disease (cGVHD). This occurs when donor stem cells attack the cells of the person who~     received them. BOS reduces airflow and oxygen levels in the body. It may be caused by~     neutrophil elastase in the body. Researchers believe the new drug AZD9668 may help.~      Objectives:~      To test the safety of AZD9668 and see what dose best inhibits neutrophil elastase in people~     with BOS after a stem cell transplant. To study how well the best dose improves lung function~     in those people.~      Eligibility:~      Adults 18 and older who have had a hematopoietic stem cell transplant and have cGVHD and BOS.~      Design:~      Participants will be screened with a medical history, physical exam, and blood and urine~     tests. They will have lung function and heart function tests. They will have computed~     tomography scans of the chest.~      Study part 1: Participants will take the starting dose of the study drug by mouth twice a day~     for 14 days. This is 1 cycle. They will get different doses, for up to 4 cycles.~      Study part 2: Participants will take the study drug twice a day by mouth at the dose set in~     part 1, for up to 12 months.~      Participants will keep medicine diaries.~      Participants will have several study visits. These may include:~      Repeats of the screening tests.~      Bronchoscopy with bronchoalveolar lavage.~      Sputum samples taken.~      6-minute walking test.~      cGVHD assessment and answer questions.~      Participants will be contacted after the study for up to 24 months.~   "
68584|NCT02669238|"~     Endometriosis is a chronic relapsing disease characterized by the presence and proliferation~     of endometrial glands and stroma outside the uterus. This is a serious disease, widespread,~     difficult to live with for the patients, but also difficult to treat for practitioners who~     take care of these patients. It affects 1.6% of the general population, but its incidence is~     10 times higher (up 40%) in patients with infertility. It occurs mainly by complex chronic~     pelvic pain and a negative influence on fertility.~      It is a disease whose complexity can be explained to four levels. Firstly, through its~     extremely polymorphic character with intraperitoneal superficial forms, ovarian forms and~     deep sub-peritoneal forms.~      Secondly by the plurality of the main symptoms which are individually non-specific and the~     frequency and / or intensity is not correlated with the severity of the disease. This~     non-specificity of symptoms partially explains the long lead misdiagnosis, which vary by 5 to~     11 years.~      Thirdly, by its prevalence which seems very high and largely underestimated. If its precise~     estimate in the general population is so complicated, it seems very high in many studies of~     patients supported surgically for gynecological reasons. These very large prevalence figures~     are observed when some consultations support the hypothesis of a widespread and probably~     insufficiently evaluated disease.~      Lately by its management, insufficiently amended, for which there is currently only a few~     scientifically supported recommendations.~      Chronic pain caused by the disease associated with altered sexuality to a loss of fertility~     significantly impacts the quality of life of patients.~   "
68585|NCT02669225|"~     Background:~      Brain activity creates waste products. The body s glymphatic system removes this waste,~     especially during sleep. One brain waste product is amyloid-beta (Ab). It plays a role in~     Alzheimer s disease. Researchers want to study the effect of sleep on Ab in the brain.~      Objective:~      To see if sleep affects the amount of waste product removed from the brain.~      Eligibility:~      Healthy people at least 18 years of age.~      Design:~      Participants will be screened with a medical history, physical exam, and blood and urine~     tests. They will answer questions about drug use, psychiatric history, and family history of~     alcoholism or drug use. Participants will complete an MRI screening questionnaire.~      Participants will stay in the clinic overnight two times. On one night they will sleep~     through the night. On the other night they will be kept awake all night. These overnight~     visits can happen in any order.~      Participants will wear 2 activity monitors, on the wrist and the ankle.~      Participants will have positron emission tomography (PET) scans. A small amount of a~     radioactive chemical will be injected through an intravenous (IV) catheter. Participants will~     lie on a bed that slides into the scanner. A cap or a special mask may be placed on the~     participant s head.~      Participants will have magnetic resonance imaging (MRI) scans. The MRI scanner is a metal~     cylinder in a strong magnetic field. Participants will lie on a table that slides into the~     cylinder. A device called a coil will be placed over the head. Participants will do a task on~     a computer screen in the scanner.~      Participants will have tests of thinking, memory, and attention. They may be interviewed,~     complete questionnaires, take pen-and-paper or computer tests, and perform simple actions.~   "
68586|NCT02669212|"~     Background:~      Post-Infectious Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (PI-ME/CFS) refers to~     long-lasting and disabling fatigue or malaise, inability to recover after exercise, and~     physical and emotional discomfort that may occur after a person has an infection. Researchers~     want to learn more about its causes.~      Objective:~      To learn more about PI-ME/CFS.~      Eligibility:~      Adults ages 18-60 years who have finished at least 7th grade education and either:~      have ME/CFS that started after an infection~      OR had Lyme disease, were treated, and returned to normal health~      OR are healthy volunteers~      Design:~      Participants will initially have a 2-5 day inpatient visit at the National Institutes of~     Health Clinical Center in Bethesda. During the visit, participants will have:~      Medical history~      Physical exam~      Intravenous (IV) line. A thin plastic tube is inserted into a vein.~      Blood and urine collected~      Magnetic resonance imaging (MRI). Participants will lie in a machine that takes pictures of~     their brain. They may get a dye through their IV.~      Grip strength tested~      Saliva, cheek swab, and stool collected~      Tilt table test with measures of body functions such as sweating and breathing, blood~     pressure, and heart rate and blood and urine sample collection~      Collection of blood cells. Participants can choose to have the blood drawn through the IV or~     through a machine that filters blood cells and returns the liquid blood back into the~     participant s vein.~      Lumbar puncture. Fluid will be removed by placement of a needle between the back bones.~      Heart monitoring~      Sleep study for participants with PI ME/CFS~      Questions about the participant s life and how they are feeling~      Questions from a neuropsychologist~      Questions from an occupational therapist for participants with PI ME/CFS~      Questinos from a nutritionist~      After the initial visit participants will return home. Participants evaluated for PI-ME/CFS~     during the first visit will have their information reviewed by an adjudication panel of~     experts in the diagnosis and care of ME/CFS to determine if they are eligible to participate~     in the second study visit.~      Eligible participants will be invited back for a second study visit. If a participant was~     taking certain medications during the first visit, they may be asked to taper off of them~     prior to the second visit and report any problems. They will also receive an activity~     monitor, fatigue diary, and nutrition log to use for at least one week prior to their second~     visit.~      Participants who are eligible will return for a 5-10 day inpatient hospital visit at the~     National Institutes of Health Clinical Center. During the visit, participants will undergo~     measurements before and up to 96 hours after performing a stationary bike exercise test. The~     purpose of the exercise test is to provoke ME/CFS symptoms (post-exertional malaise). Tests~     will be performed before and after exercise testing. These include:~      Sleeping in a room that measures how the body uses energy with EEG monitoring~      Eating a controlled diet~      Performing vigorous exercise for 10-15 minutes~      Questions about how participants are feeling~      Questions about what participants usually eat~      Samples of saliva, blood, urine and stool~      Wearing an activity monitor~      Having an Xray that measures body composition~      Thinking and memory tests~      Heart monitoring~      Transcranial magnetic stimulation. A brief electrical current to the scalp creates a magnetic~     pulse that affects brain activity.~      Magnetic resonance imaging (MRI). Participants will lie in a machine that takes pictures of~     their brain. They will do thinking and exercise tasks during the MRI.~      Lumbar puncture. Fluid will be removed by placement of a needle between the back bones.~   "
68587|NCT02669199|"~     The main purpose of this test is to assess the umbilical cord mesenchymal stem cells (MSCs)~     UC between source sample sweat gland cells wound transplanted effectiveness and safety for~     the treatment of large area skin lesions of the subjects~   "
68588|NCT02669186|"~     The proposed study is a pilot prospective, single-blinded, randomized controlled trial~     evaluating the effects of two routine, standard-of-care, anesthetic techniques on natural~     killer cell population size and cytotoxicity in patients undergoing exploratory abdominal~     laparotomies.~   "
68589|NCT02669173|"~     This study involves participants with recurrent glioblastoma brain tumors (GBM). This means~     that a participant's brain tumor has either returned after being treated by a previous~     therapy, or has continued to progress despite being treated.~      The purpose of this study is to provide proof of concept that suppression of MDSCs~     (myeloid-derived suppressor cells) is feasible in patients with GBM. Rather than targeting~     tumor cells or immune checkpoints, which has been the focus of recent therapeutic efforts,~     direct targeting of MDSCs with low dose capecitabine has the potential to reverse the~     immunosuppressed microenvironment of GBM and thereby reduce tumors~   "
68590|NCT02669160|"~     Cerebral palsy (CP) includes all the sensorimotor development disorders leading to balance,~     gait and movement disruptions. These disorders are related to lesions of the central nervous~     system (CNS) that occurs at birth or during the early childhood. The therapeutic management~     of CP is essentially based on reeducation, but may also require specific medical treatments,~     orthopedic devices and sometimes bone surgery. Therefore, CP children are very often placed~     in specialized institutions with a significant socioeconomic impact. CP children suffer from~     various sensorimotor impairments, which may evolve into orthopedic deformations, justifying~     the implementation of restrictive devices. The French High Authority of Health (HAS)~     estimates that 50 % of CP children have pains when using contention or verticalization~     devices. These pains are mainly nociceptive and are caused by the passive constraint applied~     on contact points. Many clinical trials evaluating the physiotherapy benefits on CP patients~     have led to controversial results regarding the duration of the effect of this therapeutic~     approach. However, the improvement is more important when neuromuscular facilitation~     techniques are added to the reeducation program. Human neuronal adaptation and plasticity~     mechanisms are now understood, with the possibility of a potential partial recovery.~     Non-invasive stimulation methods and neurorehabilitation techniques could participate in the~     CNS re-calibration. Automated assisted movements have already been used and these processes~     showed an increase joint range of motion, bone density and decreased spasticity.~      In recent years, exoskeleton devices have been used on subjects with spinal cord injuries~     allowing motor performances improvement.~      This pilot study aims evaluating CP children's tolerance to motorized orthosis reproducing~     walking pattern compared with conventional passive standing-up devices. For this clinical~     trial, the investigators compare the behavior of CP children using a motorized orthosis~     reproducing walking pattern (Innowalk Pro Small) to the behavior of same children placed in~     their usual conventional passive device. The investigators hypothesis is that the Innowalk~     improves joints range of motion, enhances selective motor control, decreases the medium-term~     spasticity and offers at least the same tolerance as conventional passive devices.~   "
68591|NCT02669147|"~     This is a prospective observational study to evaluate effectiveness and safety of~     Enzalutamide for Castration Resistant Prostate Cancer (CRPC) patients who decided to~     administer Enzalutamide after anti-androgen therapy.~      CRPC Patients who are observed PSA or disease progression after anti-androgen therapy and~     decided to administrate Enzalutamide will dose the Enzalutamide 160 mg orally once daily and~     observed the practical treatment. Total research term is for 4 years, consists of 2-year case~     registration terms and 2-year observational terms.~   "
68592|NCT02669134|"~     The main objective of the CRICKET study is demonstrate that AV and VV optimization using SonR~     improves LV reverse remodeling response to CRT, compared with 'Fixed Settings' (FS) after 6~     months of treatment. In this investigator-initiated, multi-centre, 2:2 factorial design,~     randomized, two-arm, double-blinded, cross-over, prospective trial, CRT recipients will be~     randomized to 'SonR' atrioventricular (AV) and ventricular-ventricular (VV) optimization or~     'fixed settings'. The primary endpoint is an absolute reduction in left ventricular~     end-systolic volume.~   "
68593|NCT02669121|"~     The purpose of this study is to evaluate the efficacy of the Norovirus (NoV) GI.1/GII.4~     Bivalent Virus-Like Particle Vaccine against moderate or severe acute gastroenteritis (AGE)~     due to genotype-specific (GI.1 and GII.4) NoV strains.~   "
68594|NCT02669108|"~     The primary objective of this study is to explore feasibility of testis functionality~     assessment and testis imaging obtained from Positron Emissions Tomography (PET) /Magnetic~     Resonance Imagine (MRI). Using advanced MRI metrics, investigators will study the~     three-dimensional structure of normal testis, the levels of specific elements and compounds~     in the tissues (which can only be found via these imaging techniques), and the directionality~     (and alterations in directionality) of tissue structure. Investigators hope to develop~     hypothesis that will in turn suggest bio-markers to be explored in subsequent clinical~     trials.~   "
68595|NCT02669095|"~     This study is a multi-site, 5-visit dispensing, bilateral double-arm parallel group design,~     double-masked clinical trial using an investigational contact lens and a marketed contact~     lens. The objective is to evaluate comfort of the contact lenses when worn on a daily wear~     modality.~   "
68598|NCT02669056|"~     Although significant advances in neonatal care have increased survival rates of preterm~     infants born before 28 weeks gestation, a concomitant decrease in neuro developmental~     disorders has not been achieved. Cerebral injuries, well documented during the previous~     years, in preterm babies are particularly deleterious since they occur in a developing brain.~     They affect both white and grey matter by complex mechanisms and the principal targets are~     the developing oligodendrocytes and neurons of the subplate. All these criteria define the~     encephalopathy of prematurity. Nevertheless, the consequences of prematurity at the level of~     the brainstem are not very well known and may explain neuro-developmental disorders with~     normal MRI.~      The assessment of the motor repertoire is complementary to the neurological examination and~     may represent a diagnostic tool for cerebral palsy, mild motor deficits and delayed~     acquisition in children. The newborn have a rich motor repertoire. GMs play a key role in the~     development due to the feedback that they send to cortical neurons and reflect the~     maturational stage of the Central Nervous System (CNS). Lesions of the brainstem caused by~     prematurity may induce alterations of the motor repertoire.~      Dysautonomic disorders, such as bradycardia, apneas, feeding problems, that occur frequently~     in very preterm babies reflect brainstem abnormalities. These symptoms are also described in~     other pathologies, in Rett syndrome and sudden infant death syndrome (SIDS). In these~     pathologies deficits of the 5-HT system have been described and associated with dysautonomia.~     It would then be interesting to evaluate 5-hydroxytryptamine (5-HT) levels in very preterm~     babies.~      The serotonergic system develops very early during gestation and is one of the first~     neurotransmitter to appear in the developing brain. The main 5-HT nuclei are located within~     the brainstem. 5-HT plays an important role in the homeostasis and the modulation of the~     respiratory network. Moreover, previous studies have shown that 5-HT projections to the~     spinal cord are involved in posture and in the coordination. It is tempting to think that~     5-HT deficits may have some repercussions on the development of the CNS, changing activity~     dependent processes, such as spontaneous activity recorded at the spinal level in rodents.~      In this project, the 5-HT platelet levels in preterm infants born before 28 weeks will be~     compared with newborns. a correlation between the levels of 5-HT with MRI of the posterior~     fossa, GMs and dysautonomia different parameters such as heart rate variability,~     suction-swallowing and different breathing techniques will be established~   "
68599|NCT02669043|"~     Anxious depression is a particularly difficult-to-treat subtype of depression. Patients with~     anxious depression do not respond as well to currently available antidepressant medications.~     Nevertheless, in previous studies, low dose IV ketamine, which rapidly decreases symptoms of~     depression within hours in many patients with treatment-resistant depression, has been~     associated with superior efficacy in those individuals with anxious compared with non-anxious~     depression. In order to understand this unique effect more fully, the current protocol is~     aimed at further delineating biomarkers of ketamine's effects among individuals with~     treatment-resistant anxious depression compared to those with nonanxious depression.~   "
68600|NCT02669030|"~     Depression with ongoing insomnia is a common clinical presentation with patients. Clinical~     data suggests that patients with insomnia that receive concomitant treatment with a sleep aid~     experience a more robust antidepressant response along with a quicker response. The purpose~     of this clinical study is to compare the effectiveness of the FDA-approved insomnia~     medication suvorexant, also known as Belsomra®, as add-on treatment to an antidepressant to~     that of placebo plus antidepressant treatment in patients with depression and residual or~     ongoing insomnia.~   "
68601|NCT02669017|"~     This study evaluates ADCT-402 in patients with Relapsed or Refractory B-cell Lineage Non~     Hodgkin Lymphoma (B-NHL). Patients will participate in a dose-escalation phase (Part 1) and~     dose expansion (Part 2). In Part 2, patients will receive the dose level identified in Part~     1.~   "
68602|NCT02669004|"~     Patient-controlled Intermittent epidural bolus versus epidural infusion for posterior spinal~     fusion after adolescent idiopathic scoliosis.~      Scoliosis surgery is commonly performed in adolescent due to idiopathic scoliosis. It is~     reported that the postoperative pain after scoliosis surgery that occurs due to Surgical~     trauma and severe reflex muscle spasm be severe and excruciating. There are many methods for~     postoperative pain management. It is used often opioid , paracetamol and non-steroidal~     anti-inflammatory drug with patient- controlled intravenous analgesia (IV-PCA). In addition;~     intrathecal opioids, one catheter epidural with intermittent dosing bolus of morphine or~     continuous infusion (either opioids or local anaesthetics or both), double epidural catheter~     with continuous infusion and intravenous ketamine infusion were preferred other postoperative~     pain management models.~      Epidural analgesia is accepted procedure with the efficacy and safety profile for~     postoperative pain management in major orthopedic surgery including scoliosis surgery.~     Epidural analgesia techniques commonly have been used in continuous infusion of local~     anesthetics with or without opioid. It was emphasized that there was not adequate data in the~     literature to provide argument concerning the use of epidural opioids after spinal surgery.~     The objective of this study was to compare the effects and side effects patient- controlled~     intermittent bolus epidural analgesia (PCIEA) and patient- controlled continuous epidural~     analgesia (PCCEA) with morphine for postoperative pain control in adolescent idiopathic~     scoliosis after posterior spinal fusion.~      Methods The study was conducted after obtaining written consent from all patients and~     guardian, approval from the Inonu University Faculty of Medicine Ethics Committee. This~     prospective randomized controlled double-blinded study was conducted 47 patient between 8-18~     years, American Society of Anesthesia Classification (ASA) I-II, with idiopathic scoliosis,~     scheduled for elective posterior spinal fusion.~      Patients with a history of allergy to the drugs used in the study protocol, drug abused ,~     preoperative neurologic deficit, inability to use a visual analogue scale, pulmonary, cardiac~     and neuropsychiatric disorders were excluded. Exclusion criteria during the study were~     accidental perforation of dura, faulty epidural catheter placement, postoperative neurologic~     deficit or uncontrollable nausea, vomiting and pruritus.~      The patients who were not premedicated were instructed on the visual analog scale (VAS) and~     the patient-controlled analgesia (PCA) device that was implanted during the postoperative~     period.~      Patients were divided into two groups using the envelope drawing method. Patients who~     received epidural morphine with PCIEA represented Group 1, epidural morphine with PCCEA~     represented Group 2. The anesthetist who collected data and the patients were blinded.~      All operations were performed by the same surgical team. The posterior instrumentation with~     pedicle screws was applied to thoracic and lumbar spine. Epidural catheter was inserted by~     surgeon under direct visualization at the midpoint of the incision and advanced 5-6 cm~     cephalad to thoracic 4-5 before surgical closure. Intubated patients was taken to in the~     reanimation intensive care unit after operation, IV acetaminophen 15 mg / kg was started~     before extubation and repeated every 6 hours.~      After extubation and a neurological examination, patients in the PCİEA group received~     morphine 50 µg/kg in 10 mL bolus, lockout time 1 hour, no infusion. In Group 2, PCECA~     infusion the following initial setting loading morphine 0.02mg/kg in 8mL, was maintained 0.01~     mg/kg continuous infusion 4mL, 0.05 mg/kg 2mL bolus dose. 30 minute lock-out interval. 4 hour~     limit was 4 mg/kg.~      Pain score, morphine usage, postoperative nausea and vomiting, pruritus, rate their~     satisfaction ,sedation scores and motor block were assessed by researchers who were blinded~     to the study groups at postoperatively 2., 4., 6., 8., 12., 18., ve 24.hour, in all patients.~   "
68603|NCT02668991|"~     The purpose of this study is to evaluate the utility of and to clinically validate the Autism~     Behavior Inventory (ABI) in measuring clinical symptoms of Autism Spectrum Disorder (ASD)~     compared with other gold standard measures.~   "
68604|NCT02668978|"~     The primary objective is to assess the efficacy and safety of HEMOPATCH™ Sealing Hemostat in~     reducing the incidence and duration of air leaks after lung resection compared to standard~     techniques.~      Hypothesis: The routine application of HEMOPATCH Sealing Hemostat on the visceral pleura in~     lung resection areas, during lung resection procedures, is more EFFICIENT to reduce the~     incidence and duration of prolonged air leaks as compared to standard surgical measures.~   "
68605|NCT02668965|"~     The purpose of this study is to determine whether intrauterine hCG can improve the~     implantation rate and clinical pregnancy rate after embryo transfer in IVF/ICSI cycle.~   "
68606|NCT02668952|"~     Acute kidney injury (AKI) is a potential complication of cardiac surgery. In animal models,~     excess exogenous Cl- ion in the bloodstream is associated with AKI. Normal saline IV fluid~     has higher levels of Cl- ion than the blood usually carries. An alternative IV fluid sold~     under the name Isolyte has lower Cl- ion levels. There is no literature comparing AKI~     outcomes in cardiac patients between patients receiving normal saline vs. Isolyte. The~     investigators propose to recruit and randomize 30 trial-completing cardiac surgery patients~     (up to 40 enrolled) into 2 study arms and compare renal outcomes.~   "
68607|NCT02668926|"~     The study will compare the acute emotional and endocrine effects of equivalent doses of~     lisdexamfetamine and amphetamine in healthy subjects. In addition the pharmacokinetics and~     effects of the amphetamines on aspects of social cognition are investigated.~   "
68608|NCT02668913|"~     This is a pilot feasibility study assessing the use of a commercial molecular profiling~     service in the UK's National Health Service (NHS). The impact of knowledge of a patient's~     molecular profile, and the time it takes to generate this knowledge, will be assessed by~     analysis of changes in physicians' treatment decisions prior to and following generation of a~     patient's molecular profile. Implications for benefit with therapies recommended by the~     profile will also be assessed and the following treatment outcomes collected: best response~     (based on routine clinical, radiological and biochemical assessment), progression free~     survival ratio (post Caris Molecular profiling versus prior treatment) and overall survival.~   "
68619|NCT02668770|"~     The goal of this clinical research study is to find the highest tolerable dose of MGN1703~     that can be given in combination with ipilimumab to patients with advanced tumors. The safety~     of this drug combination will also be studied.~      This is an investigational study. MGN1703 is not FDA approved or commercially available. It~     is currently being used for research purposes only. Ipilimumab is FDA approved and~     commercially available for the treatment of unresectable (cannot be removed with surgery) or~     metastatic (has spread) melanoma.~      Up to 60 participants will be enrolled in this study. All will take part at MD Anderson.~   "
68675|NCT02668029|"~     Patients with pulmonary fibrosis often desaturate on exercise. There are no data showing~     whether ambulatory oxygen can be useful to improve exercise capacity in this condition.~     Ambulatory ambulatory oxygen is often denied to these patients based on studies conducted on~     patients with chronic obstructive pulmonary disease, a completely different condition for~     physiopathology, prognosis, and response to therapy. We therefore planned a controlled study~     to verify the usefulness of ambulatory oxygen in patients with pulmonary fibrosis~   "
68609|NCT02668900|"~     The implantable-cardioverter defibrillator (ICD) is a small medical device used to treat~     dangerously fast and potentially life-threatening heart rates. For patients at risk, the ICD~     can detect an abnormal rhythm and provide life-saving therapy by delivering a shock. ICD~     therapy has risks and benefits that should be weighed from each patient's perspective. An ICD~     battery needs to be surgically replaced 4 to 7 years to ensure ongoing function. At present,~     the majority of these batteries are automatically changed without eliciting patients'~     preferences. There is a need for a better way to engage with patients. Patients want to be~     involved in their healthcare decisions, yet more than half of patients with an ICD do not~     know that ICD replacement is optional. To ensure that patients are receiving treatment that~     they value and want, members of the interprofessional team should ensure that treatment~     decisions align with patients' expectations, values and preferences. This rests on the~     principle of shared decision making in which members of the healthcare team and patients~     deliberate together to arrive at a decision which best reflects the preferences and values of~     the patient. To facilitate the achievement of this goal, a patient decision aid (PDA) can be~     used. As a result, the investigators developed PDA for ICD replacement. The purpose of this~     feasibility trial is to collect preliminary data to test the feasibility of conducting a~     larger trial, and to evaluate the PDA for its acceptability and ease of use. Eligible and~     consented participants facing ICD replacement will be randomized to receive the decision aid~     or to usual care. The investigators will assess if this decision aid can improve~     participants' knowledge on ICD therapy and the replacement surgery, increase patients'~     perceived involvement in the decision, and determine whether their actual choice reflects~     their personal values.~   "
68610|NCT02668887|"~     Within the first year after diagnosis, data on employment and quality of life will be~     collected and evaluated in patients with malignant melanoma~   "
68611|NCT02668874|"~     The purpose of this split-mouth, randomized, controlled trial is to evaluate the retention~     rates of sealants placed under Isolite vs. cotton roll isolation. This study will also~     compare the patient and operator acceptability and satisfaction of the two isolation~     techniques as well as the time consumed for sealant application during the two isolation~     techniques.~   "
68612|NCT02668861|"~     The purpose of the study is to test the clinical efficacy of oral Vitamin D3 on Wound Healing~     in patients with Chronic Rhinosinusitis With Nasal Polyposis and Lower Vitamin D Levels After~     Endonasal Endoscopic Sinus Surgery~   "
68613|NCT02668848|"~     The investigators previously found that a blood urea nitrogen/creatinine (BUN/Cr) ratio >15~     is an independent predictor of early deterioration after acute ischemic stroke. Another study~     was conducted to determine whether urine specific gravity, another indicator of hydration~     status and one more easily obtained, is also an independent predictor of early deterioration~     or stroke-in-evolution (SIE) in such patients. The investigators also conducted a preliminary~     study, enrolling ischemic stroke patients with a BUN/Cr ratio >15 and find daily Bun/Cr based~     hydration help to decrease post stroke infection rate and improve 3 months functional~     outcome. In this study, daily urine specific gravity will be used to adjust hydration therapy~     in ischemic stroke patients with initial Bun/Cr ratio <15. The primary outcome is the post~     stroke infection rate in the first 7 days after admission, and secondary outcome is 3 months~     functional outcome using mRS.~   "
68614|NCT02668835|"~     The proposed study will capitalize on the early predictive information stored in an~     individual's genetic risk for Parkinson Disease (PD) in combination with the subtle features~     of tremors that can be extracted from movement data gathered by modern compact accelerometers~     in order to determine if accurate discrimination of essential tremor (ET) from PD can be~     achieved. Both of these technologies have a proven but somewhat limited ability to inform~     diagnosis of PD or differentiation of PD from ET - especially at early stages of the disease.~     The investigators hypothesize that a combination of prior genetic risk and current disease~     symptomology can synergize for accurate and early discrimination of PD from ET and ultimately~     inform a cost effective approach to movement disorder diagnosis.~      In this study, the investigators will collect blood from individuals with confirmed~     late-onset diagnosis of PD and ET. Gold standard diagnosis status will be determined via the~     Unified Parkinson's Disease Rating Scale (UPDRS) - the accepted clinical gold standard for~     Parkinson's Disease diagnosis. DNA will be extracted from blood samples to characterize the~     genetic risk of individuals for PD via proven genetic risk models. In addition, participants~     will wear a wristwatch-like accelerometer device that will track their movements (tremors) at~     high temporal resolution and transmit movement data via a smartphone. Cognitive distraction~     tasks will be administered via mobile phones while simultaneously collecting movement data.~     Predictive tremor features will be extracted from movement data via signal processing~     approaches - e.g. discrete wavelet transformation. A final predictive model combining~     movement tracking information and genetic information will be designed in attempt to~     distinguish PD from ET individuals.~   "
68615|NCT02668822|"~     The purpose of this study was to evaluate the efficacy of the etonogestrel (ENG) +~     17β-estradiol (E2) (MK-8342B) vaginal ring compared to placebo vaginal ring in the treatment~     of dysmenorrhea at Treatment Cycle 2. This study was also to assess the safety and~     tolerability of the ENG-E2 vaginal rings over 4 treatment cycles. Primary hypothesis:~     Relative to the placebo ring, the ENG-E2 vaginal ring results in a greater proportion of~     participants with a ≥3-point reduction in peak pelvic pain score and no increase in the~     number of rescue pain relief (ibuprofen) tablets taken at Treatment Cycle 2 as compared to~     baseline.~   "
68616|NCT02668809|"~     The main goals of this pilot study are to develop a nursing home-customized oral hygiene~     protocol, intended to be delivered primarily by dental hygienists and primary care providers,~     and to identify potential obstacles and barriers to overcome in designing a subsequent~     definitive study on the same topic.~   "
68617|NCT02668796|"~     This is a Randomized, Parallel-Group, Placebo- Controlled, Multicenter Study to Evaluate the~     Therapeutic Equivalence and Safety of Estradiol Vaginal Tablets 10 mcg and Vagifem®~     (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk Inc.) in Female Subjects with Moderate to~     Severe Symptoms of Vulvar and Vaginal Atrophy Associated with Menopause.~   "
68618|NCT02668783|"~     The purpose of this study is to assess the etonogestrel (ENG) + 17β-estradiol (E2) vaginal~     ring's efficacy compared to a placebo vaginal ring in the treatment of dysmenorrhea at~     Treatment Cycle 2. In addition, this study will assess the safety and tolerability of the~     ENG-E2 vaginal rings. Primary hypothesis: Relative to the placebo ring, the ENG-E2 vaginal~     ring results in a greater proportion of participants with a ≥3 point reduction in peak pelvic~     pain score and no increase in the number of rescue pain relief (ibuprofen) tablets taken at~     Treatment Cycle 2 as compared to baseline.~   "
68673|NCT02668055|"~     Evaluation of slow-release Tb4 collagen and chitosan porous sponge scaffolds skin substitutes~     the effectiveness of clinical trials for the treatment of difficult to heal wounds and~     security.~   "
68620|NCT02668757|"~     The HeartHab study is a pilot trial in which coronary artery disease patients (n = 15-30) are~     given the HeartHab application. The HeartHab application is a smarthphone based mobile~     application that serves as a secondary prevention tool, to support cardiac patients after~     their phase II cardiac rehabilitation program. During study period (4-6 weeks), participating~     patients will be asked to use the application. HeartHab includes a module devoted to therapy~     compliance, one to exercise training prescription and one to risk factor control. HeartHab~     aims to motivate the patient to improve his/her self-management skills and hence decrease~     cardiovascular morbidity (and mortality).~      Motivational aspects and usability data will be collected during study period by means of app~     logs and/or questionnaires/interviews.~   "
68621|NCT02668744|"~     The investigators recently completed an NIH R21 grant, which was a randomized controlled~     trial (RCT) to test the effects of a gardening, nutrition, and cooking program in 375~     low-income Hispanic students living in Los Angeles. Preliminary results from this study show~     that intervention compared to the control students have reductions in BMI parameters and~     waist circumference, increases in daily intake of dietary fiber and vegetables, and improved~     lipid profiles. The investigators want to expand and replicate this study by: a) using a~     cluster randomized school design; b) implementing the program during school hours; c)~     increasing sample size; d) lengthening the intervention period to one school year; e)~     collecting comprehensive metabolic measurements on the child; f) enhancing family workshops;~     g) collecting more parental data; and h) developing and evaluating sustainability strategies.~     Thus, the overall goal of this project is to test the effects of a large school-based~     gardening, nutrition, and cooking RCT (called Sprouts) on dietary intake, dietary-related~     behaviors, obesity, and related metabolic disorders in low-income Hispanic youth and their~     families in Central Texas. Sixteen elementary schools will be randomized to either: 1)~     Sprouts intervention or 2) Control (delayed intervention). At each intervention school, the~     investigators will build edible gardens; form and train Garden Leadership Coalitions (GLCs);~     teach 20 Sprouts in-school lessons to the students; and teach nine family-based Sprouts~     lessons throughout school year. The following measures will be obtained for students at~     baseline and post-intervention: height, weight, BMI, waist circumference, body composition~     (via bioimpedance), blood pressure, glucose, insulin, and lipids (via voluntary fasting blood~     draws), dietary intake, and related psychosocial behaviors (e.g.,~     preference/motivation/self-efficacy to eat FV). The investigators will also measure~     anthropometrics, dietary intake, and related dietary psychosocial variables on the parents at~     baseline and post-intervention. After the intervention year, the investigators will provide a~     series of training workshops and resources to the GLCs and schoolteachers to sustain the~     Sprouts program in subsequent years. The investigators will measure the sustainability~     employed by each school by process logs/surveys, structured interviews, and school~     observations.~   "
68622|NCT02668718|"~     The purpose of this study is to determine whether adjuvant radiotherapy following radical~     prostatectomy in prostate cancer patients with positive margins or capsular penetration~     improves biochemical, overall and/or cancer specific survival and whether adjuvant~     radiotherapy is reasonably well tolerated when compared to watchful waiting.~   "
68623|NCT02668705|"~     Both the main and sub-studies will investigate how consent forms and other health care~     documents are explained to patients. The findings will be used to create a computer program~     that can successfully explain consent and other health-related forms to individuals who have~     difficulty reading and understanding consent forms on their own as a supplement to the normal~     consent process done in research settings.~   "
68624|NCT02668692|"~     To compare the efficacy and safety of LEO 80185 gel with Dovobet® ointment in the treatment~     of psoriasis in Japanese subjects.~   "
68625|NCT02668679|"~     Background: Performance of endoscopy in children requires more patience, experience, and~     expertise than in adults. The anxiety of the children is related to parent's separation, loss~     of self-control, unknown surroundings and strange people that are taking care of them, and~     frequently unpleasant or even painful procedures. Painful and frightening procedures in~     children have been shown to result in short-term physiologic changes and long-term behavioral~     changes. The response to unpleasant stimuli with stress and fear may be exaggerated in~     children and experienced as pain. Most infants and children and many teenagers need deep~     sedation or light general anesthesia to complete a successful and safe procedure. Induction~     of general anesthesia is a stressful procedure itself. Strategies to reduce preanesthesia~     anxiety include pharmacologic and non-pharmacologic interventions.~      However, this evidence is based mainly on self reports rather than objective measurements.~     Therefore, objective and non-invasive measurements to be utilized in the current study,~     should provide an assessment tools regardless the children's age.~      Multiple studies, beginning in the 1970's, have shown that humor has many positive effects on~     physical and mental health and well-being. Previous investigations have reported that humor~     has beneficial effects on the immune system, stress related to potentially fatal illnesses,~     pain tolerance, and mental functions.~      Dream doctors (DDs) are professional medical clowns or stage artists, who received training~     specifically to understand medical patient's need and to give the patient adjuvant therapy~     during hospital admissions or ambulatory treatment.The Israel dream doctors project,~     integrates professional medical clowning into the medical services provided at Israeli~     hospitals.Studies already proved that presence of medical clowns significantly reduces the~     level of anxiety during induction of anesthesia in children. Hypothesis of the study: 1) DDs~     lessen the level of anxiety and attention impairment in children undergoing gastroscopies. 2)~     DDs improve the satisfaction of children and their parents during gastroscopies.~      The aim of this study is: 1) To explore the influence of DDs on the satisfaction of children~     and their parents undergoing gastroscopy, utilizing questioners. 2) To explore the effects of~     DDs on anxiety and attention of children and their parents, undergoing gastroscopies by means~     of GSR, startle response and pre-pulse inhibition (PPI) tests, as well as , and measuring~     anxiety-related biologic indices.~   "
68626|NCT02668666|"~     This is a non-randomized, open-label, single-arm, multicenter, phase II study of palbociclib~     in combination with tamoxifen in women with HR(+)/HER2(-) advanced breast cancer who have not~     received prior systemic anticancer therapies for their advanced/metastatic disease.~   "
68627|NCT02668653|"~     This is a phase 3, randomized, double-blind, placebo-control global study. The purpose of~     this study is to compare the effect of quizartinib versus placebo (administered with standard~     induction and consolidation chemotherapy, then administered as maintenance therapy for up to~     12 cycles) on event-free survival in subjects with FLT3-internal tandem duplication (ITD)~     positive AML.~   "
68628|NCT02668640|"~     The study is a non-interventional, observational study is to assess the effect of Adalimumab~     on health-related quality of life and work productivity in patients with Rheumatoid Arthritis~     (RA) in China.~   "
68629|NCT02668627|"~     Based on the results of recent randomized controlled trials, current international guidelines~     recommend the initiation of endovascular treatment within 6 hours of symptom onset for acute~     ischemic stroke. Endovascular treatment may be beneficial in selected patients beyond 6 hour~     time window. In particular, treatment response to endovascular therapy may be greatly~     influenced by pretreatment collateral status. The aim of this study is to evaluate whether~     MRI-based collateral imaging (the Fast Analysis SysTem for COLLaterals, 'FAST-COLL') is~     feasible and can predict the response to endovascular treatment in a wide range of patients~     with acute ischemic stroke .~   "
68674|NCT02668042|"~     The main purpose of this experiment was to evaluate the activity of tissue engineering skin~     substitutes safety and efficacy studies for the treatment of difficult to heal wounds~   "
68691|NCT02667821|"~     The Investigators are performing a study to determine, in patients with chronic/recurrent~     neck pain, the cerebrovascular hemodynamic consequences of cervical spine movements,~     including manipulation, in vivo using fMRI technology on vertebral and cranial blood flow~     dynamics affecting brain perfusion, and extend the current data set on these variables~   "
68630|NCT02668614|"~     Skin cancer represents a large problem in today's healthcare setting. The majority of cancer~     diagnoses are attributed to malignant skin diseases including its major types: basal cell~     carcinoma, squamous cell carcinoma and melanoma. Early diagnoses is critical given early~     detection of malignant lesions largely increases chances of successful treatment. The current~     gold standard of diagnosis is histopathological examination of biopsied skin. Biopsies are~     not only invasive and expensive, they have variable positive predictive value, meaning they~     may often be preformed unnecessarily. As such, we have developed a skin scanner, which is~     less bulky and expensive that existing similar technologies, as a tool to evaluate skin~     lesions prior to determining the need for a biopsy. Our objective is to obtain information in~     order to validate this skin scanner in the context of its ability to accurately identify~     basal cell carcinoma skin lesions.~   "
68631|NCT02668601|"~     Our studies are aimed at examining effects of intrauterine exposure to GDM on metabolic risks~     in Hispanic children. Our primary hypothesis predicts that intrauterine exposure to GDM will~     be associated with one or more of three critical factors involved in the development of~     diabetes: 1) increased adiposity, 2) insulin resistance, and 3) decreased beta cell function~     in Hispanic children when compared to non-exposed children matched for ethnicity, age,~     gender, and Tanner stage. In a subset of this cohort, we will also examine the effects of~     intrauterine exposure to gestational diabetes on the brain pathways that regulate appetite~     and body weight in children ages 6 to 15 years old.~   "
68632|NCT02668588|"~     This is a multicentre, double blind, randomized placebo controlled trial to assess the effect~     of LF-PB on seroma formation in women with breast cancer undergoing Axillary Lymph Node~     Dissection (ALND).~      Recruited patients will be randomly assigned to receive LF-PB 30 mg or placebo.~   "
68633|NCT02668575|"~     Individuals living with cystic fibrosis (CF) commonly report high symptom burden, poor~     quality of life, and additional psychosocial stressors; these burdens are particularly~     heightened in advanced stages of the disease. Although supportive care (aka palliative care)~     has been shown to improve many of these outcomes among patients with illnesses such as~     cancer, no clinical trials to date have tested the impact of supportive care for patients~     with CF. The purpose of this pilot randomized clinical trial study is to evaluate the~     feasibility, acceptability, and perceived effectiveness of an embedded supportive care~     intervention, whereby a supportive care specialist will be integrated within the usual care~     experience of patients with advanced CF. The investigators will enroll 50 patients with~     advanced CF, who will be equally randomized to receive this embedded supportive care~     intervention or usual care. Secondary measures include: patient quality of life, mood, coping~     style, satisfaction with care, and symptom burden. This study will provide preliminary data~     to support the development of a larger, definitive, Phase III randomized clinical trial.~   "
68634|NCT02668562|"~     Ticagrelor, a more potent P2Y12 inhibitor, has been shown to reduce major adverse cardiac~     events (MACE) in acute coronary syndromes (ACS). It is increasingly used as a first line~     therapy in ACS. However, more potent P2Y12 inhibition has been associated with increased~     bleeding. This may be of particular concern for patients with ACS who require coronary artery~     bypass surgery (CABG). In particular, the timing for cessation of ticagrelor before~     proceeding to CABG is unclear. RAPID TITRATE CABG is a randomized vanguard study to evaluate~     the feasibility and preliminary safety of a strategy of early versus delayed CABG in ACS~     patients initially treated with ticagrelor and to identify potential mechanisms underlying~     benefits or complications of early bypass surgery.~   "
68635|NCT02668549|"~     The purpose of this study is to formulate definitions of doctor/pharmacy shopping and~     evaluate its association with abuse/addiction~   "
68636|NCT02668536|"~     The initial focus of the study will be on safety, sun protection factor (SPF)~     characterization, and substantivity (duration of protection) studies. The primary outcome of~     the study will be to measure the sun protection factor (SPF) of a bioadhesive nanoparticles~     (BNP) formulation in 20-25 healthy volunteers with fair skin.~   "
68637|NCT02668523|"~     The objective of this study is to evaluate the safety and effectiveness of the Raindrop Near~     Vision Inlay implanted in bilateral pseudophakes with presbyopia for improvement of near and~     intermediate vision.~   "
68638|NCT02668510|"~     A Randomized Controlled Pilot Trial Comparing Extracorporeal Shock Wave Therapy with Platelet~     Rich Plasma versus Extracorporeal Shock Wave Therapy in a High Demand Cohort with Resistant~     Plantar Fasciitis~   "
68639|NCT02668497|"~     The primary objective is to study the efficacy of botulinum toxin type A (BoNT-A) injected~     via kinematic parameters in the treatment of unilateral/bilateral upper extremity tremor in~     Parkinson's disease (PD) tremor. Kinematic assessment tools already developed in past~     clinical studies will be used in determining injection parameters. The objective is to study~     the composition of PD tremor using kinematic tools which may contribute to the knowledge of~     tremor complexity and contribute information that would benefit the development of injection~     parameters to improve efficacy and optimization of BoNT-A in tremor management. By injecting~     all bothersome tremulous upper limbs in Parkinson's disease patients, the investigators~     believe a greater improvement in Quality of Life on more daily tasks can be achieved compared~     to the investigator's earlier study in unilateral injections (REB#101749), which already~     showed significant improvement.~   "
68640|NCT02668484|"~     There are different aortic valve prosthesis used for treatment of aortic valve disease~     through catheter-based procedures. The current study aims to compare two different aortic~     valve prosthesis regarding their outcomes at 30-day and 2-year follow-up.~   "
68641|NCT02668471|"~     The purpose of this study is to compare the efficacy of ultrasound- guided with the~     traditional palpation radial artery cannulation in critically ill children.~   "
68642|NCT02668458|"~     The aim of the study is to evaluate the incidence of severe hypoxemia episodes during the~     intubation procedure with two methods of pre-oxygenation:~        1. NIV (Non Invasive Ventilation)~        2. HFNC (High-flow nasal canula oxygen therapy)~   "
68643|NCT02668445|"~     This is a randomized, counterbalanced crossover design, in which 14 male subjects will~     complete two experimental trials. Each trial will be separated by a minimum of at least 12~     days (range: 12-30 days). The study aims to investigate the effects of low glycogen~     availability on skeletal muscle molecular response after a concurrent exercise day.~   "
68644|NCT02668432|"~     Purpose/Objectives: Severe sepsis and septic shock are a common cause of new onset atrial~     fibrillation (NOAF) in the intensive care unit. Development of NOAF in this setting can~     prolong length of stay and increase mortality. Amiodarone is the most commonly used agent~     used in this setting to control rate and rhythm. However, limited data exist detailing~     appropriate dosing in this setting. The primary objective of this study is to evaluate two~     amiodarone dosing strategies, a full loading dose versus a partial loading dose, in patients~     with new-onset atrial fibrillation (AF) due to severe sepsis or septic shock to assess the~     mean heart rate every 6 hours after initiation of amiodarone infusion to day 7 or death.~      Research Design/Plan: Consecutive patients admitted to the medical or cardiac intensive care~     unit at University Hospital with NOAF in the setting of severe sepsis or septic shock will be~     screened for study inclusion. Data will be collected and stored using Microsoft Excel or~     Access and analyzed with JMP 12.0 and SPSS.~      Methods: Patients aged 18 years or older who develop new-onset atrial fibrillation in the~     setting of severe sepsis or septic shock and in whom the medical team deems appropriate to~     initiate amiodarone therapy in will be considered for study inclusion. Patients will receive~     intravenous (IV) and oral (PO) amiodarone, as per the standard of care. Patients will be~     randomized to a certain quantitative loading dose strategy; either a full loading dose (≥ 5g~     IV or ≥10g PO +/- 20%) or a partial loading dose (<4g IV or < 8g PO).~      Clinical Relevance: With intensive care unit length of stay (ICU LOS) and mortality being~     twice as high in NOAF with sepsis as compared to septic patients without NOAF, the~     investigators ultimately aim to identify a management strategy that may minimize this~     morbidity and mortality while also minimizing exposure to a drug that may cause serious~     adverse effects.~   "
68645|NCT02668419|"~     The purpose of this study is to determine whether neuromuscular electrical stimulation can~     improve exercise tolerance for patients with heart failure and continuous dobutamine use in a~     hospital.~   "
68646|NCT02668406|"~     Clinical samples [blood and voided urine (only for phase A)] from patient recruited at~     Sihanouk Hospital Centre of HOPE (SHCH) and HOPE Community Medical Center (CMC) will be~     processed (decontamination) and shipped to SRI International with the purpose of design and~     validation (proof of concept) and (case/control series) of in-vitro diagnostics for~     melioidosis.~   "
68647|NCT02668393|"~     Phase I study. To determine the MTD (Maximum Tolerated Dose) of nintedanib + weekly Docetaxel~     in patients with locally advanced or metastatic lung adenocarcinoma after failure of~     platinum-based first line chemotherapy.~   "
68648|NCT02668380|"~     This is an Open Label, Prospective, Multicentre, Non-interventional Study of Apatinib for~     Chemotherapy-Refractory Advanced Metastatic Gastric Cancer, the investigators opted to give~     patients for apatinib 850 mg once daily, 28 days for a cycle. To evaluate the safety and~     efficacy of apatinib for Advanced Metastatic Gastric Cancer in the real world.~   "
68649|NCT02668367|"~     This is a single center, sequential-cohort, double-blind, placebo-controlled, multiple~     ascending dose (MAD), 7-day treatment period study in healthy subjects.~   "
68650|NCT02668354|"~     The aim of this study is to investigate the spectrum of various types of malignant neoplasms~     of infancy, according to the experience of South Egypt Cancer Institute, which represents the~     largest referral site in Upper Egypt.~   "
68651|NCT02668341|"~     Analysis of barriers in psoriasis care from the patient's and the physician's perspective and~     generation of scientific data on the quality of health care in Denmark, Poland, Spain, United~     Kingdom, and Germany~   "
68652|NCT02668328|"~     The proposed study is an integrative scientific undertaking, reflecting the input of experts~     in the behavioral sciences, mHealth technology, computational biology, endocrinology,~     biochemistry, and nutrition. The project features a unique translational approach, connecting~     behavior and biology in an economical manner that provides mechanistic insights into the~     progression of type 2 diabetes (T2D) and the biologic consequences of behavior change. The~     project may have profound implications for the clinical management of early T2D.~   "
68653|NCT02668315|"~     Allogeneic hematopoietic stem cell transplantation is a life-saving procedure in patients~     with blood cancers, but only 25% of transplant candidates have a sibling donor. A matched~     unrelated donor can be found for 60% of patients but this number is lower for non-Caucasians.~     Cord blood (CB), another source of stem cells, has major advantages over unrelated donors~     including immediate availability, better permissiveness in immune mismatches between donor~     and transplant recipient, better availability for non-Caucasians, and less graft versus host~     disease, a complication frequently seen after transplant which negatively affects quality of~     life. Unfortunately, the use of CB is still limited in adults because of the small number of~     stem cells. UM171, a molecule with hematopoietic stem cell expansion properties, has been~     shown to increase cord blood stem cells 13 fold. In this trial, Investigators will use UM171~     treated CB in patients who need a transplant but lack an acceptable donor.This protocol seeks~     to test the safety of CB cells expanded with UM171, and to determine the kinetics of~     engraftment as well as the minimal cord blood unit cell dose that when expanded achieves~     prompt engraftment.~   "
68654|NCT02668302|"~     Randomized, controlled, double-blinded clinical trial with 40 patients randomized in 1:1~     ratio to either treatment (bilateral in-office placement of Propel following ESS) or control~     (post ESS standard of care) group and followed for 6 months~   "
68655|NCT02668289|"~     The purpose of this trial is to determine the correlations between various tissue dimensions~     and the changes that occur following a single-tooth dental extraction in human adults.~      65 adult subjects who are in need of dental extractions will be recruited. Clinical~     measurements will be gathered prior to and immediately following the single tooth extraction.~     There will be a 2-week post-operative visit to assess healing and a 14-week follow-up for~     photographic documentation and clinical measurements of the extraction area.~   "
68656|NCT02668276|"~     This research is being done to better understand how a new lab test called the Oncotype DX~     Prostate Cancer Assay may impact what treatment men decide to get and how they feel and think~     about their choice of treatment. The study will compare men who receive this new lab test~     with men who receive the usual counseling given to men after they get a new diagnosis of~     prostate cancer. Prostate cancer is sometimes slow-growing and sometimes fast-growing.~     Healthcare providers are searching for better ways to predict how each tumor will behave so~     that each man can make a better decision about when to receive treatment. The Oncotype DX lab~     test uses leftover prostate biopsy tissue to generate a Genomic Prostate Score (GPS). The GPS~     is related to the risk of a fast-growing cancer being discovered if surgery is performed to~     remove a man's prostate. The goal of this study is to find out if this test helps men when~     they are deciding how their prostate cancer will be treated. Treatment options include~     surgery to remove the prostate, radiation therapy, or an approach called active~     surveillance in which there is no immediate therapy and the tumor is watched using prostate~     specific antigen (PSA) tests and repeat biopsies.~   "
68657|NCT02668263|"~     Seroma formation is a common complication following breast and axillary surgery for breast~     cancer. The use of drains is commonplace in practice after mastectomy, although there is~     evidence to suggest that they do not affect the incidence of symptomatic seroma formation.~     Methods have been adopted in attempts to decrease seroma formation, to varying results, which~     include the use of deep sutures. The aim of this study is to evaluate the effect of drains~     and quilting sutures on the incidence of seroma formation. Patients undergoing mastectomy and~     axillary surgery for breast cancer will be eligible. Patients will be randomized to either~     receive a drain, no drain or no drain with quilting sutures. The primary outcome measure will~     be the incidence of symptomatic seroma. Secondary outcome measures will be postoperative~     length of stay and postoperative pain scores.~   "
68658|NCT02668250|"~     With the increasing aging population demographics and life expectancies, the number of very~     elderly patients undergoing surgery is rising. Elderly patients constitute an increasingly~     large proportion of the high-risk surgical group.~      Cardiac complications and postoperative pulmonary complications are equally prevalent and~     contribute similarly to morbidity, mortality, and length of hospital stay. Specific~     optimization strategy of general anesthesia has been tested in high-risk patients undergoing~     major surgery to improve outcomes.~      Our hypothesis is that a combined optimization strategy of anesthesia concerning hemodynamic,~     ventilation, and depth of anesthesia may improve short- and long- term outcome in elderly~     undergoing high risk surgery.~   "
68659|NCT02668237|"~     Community-Acquired Pneumonia (CAP) of children are a recurrent pathology with multiple~     severity scores. The etiology is never really identified, and the initial treatment is always~     based on probabilistic antibiotics, in the case of an bacterial infection, and by the way,~     potentially severe.~      Molecular tests (multiplex) allow the simultaneous detection of a huge number of pathogenic~     agents, virus and bacteria, are now available.~      This project is based on a new strategy of diagnostic, using a multiplex PCR with quick~     results, coupled to an antigenic urinary test to allow a complete, quick, etiologic~     diagnostic as soon as children are supported in emergency.~      Children are randomized in two groups during inclusions : quick diagnostic strategy versus~     usual practice. Analyse will be centralized on anti-infectious treatment optimization, with~     the aim to better treat patients, minimize the costs, and decrease selection pressure of~     multi-resistant bacteria.~   "
68660|NCT02668224|"~     It is a randomized, controlled clinical trial, in healthy volunteers. They are in two groups~     : the test one will perform the vibration training (1h of Vibrasens 3 times a week, 24~     sessions) whereas the control group will not be training. The primary outcome is the maximal~     voluntary strength.~   "
68661|NCT02668211|"~     MicroPort Orthopedics (MPO) is conducting this study to investigate the primary stability of~     its PROFEMUR® Preserve Femoral Components using radiostereometric analysis (RSA). RSA allows~     precise measurement of micromotion around orthopedic implants and hence, may estimate~     long-term fixation to bone.~   "
68662|NCT02668198|"~     The purpose of this study is to compare the accuracy of using different endoscopic imaging~     technique (white light, white light with near focus, narrow band imaging (NBI), NBI with near~     focus) for detection of residual neoplastic tissue at site of prior EMR~   "
68663|NCT02668185|"~     Placebo-controlled, double-blinded, cross-over clinical trial of a new investigational~     product~   "
68664|NCT02668172|"~     The objective of this study is to assess the efficacy of Pasireotide Long Acting Release~     (LAR) alone and in combination with weekly Pegvisomant (PEGV) in acromegaIy patients~     previously controlled with combination treatment of long-acting Somatostatin analogs~     (LA-SSAs) and PEGV.~   "
68665|NCT02668159|"~     The overall goal of this study is to investigate the effects and the mechanisms of action of~     a fish peptide and vitamin D on glucose metabolism, insulin secretion, and cardiometabolic~     risk profile in overweight men. Transcriptomic and metabolomic approaches will be used to~     study the acute physiological effects of fish nutrients and to discover gene/metabolite~     networks that underlie these effects.~   "
68666|NCT02668146|"~     Obtain information on whether the medication Perampanel reduces tremor in people with~     essential tremor and is well-tolerated.~   "
68667|NCT02668133|"~     Background: Community based-intervention trials conducted among infants and young children in~     low- and middle-income countries have found that zinc supplementation of young children (in~     the form of liquid supplements or dispersible tablets) increases linear growth and weight~     gain, and reduces the prevalence of diarrhea and respiratory infections, and lowers all-cause~     mortality. Aside from supplements, additional dietary zinc can also be provided through~     home-fortification of complementary foods with small-quantity lipid-based nutrient~     supplements (SQ-LNS; 20g/d), which are typically formulated as a peanut-based paste enriched~     with a vitamin and mineral complex containing 8 mg elemental zinc (as ZnSO4). However, the~     efficacy of LNS as a delivery vehicle for preventive zinc supplementation remains uncertain.~     Two recent studies, which provided LNS containing 4-10 mg Zn daily for 6-9 months found no~     significant differences in plasma zinc concentrations at the end of the intervention period~     compared to placebo.~      This lack of response may be due to the reduced absorption of zinc when it is part of a~     complex food matrix and provided with cereal-based meals; both SQ-LNS and cereal grains~     contain moderate to high concentrations of phytate, the main dietary factor known to~     substantially reduce zinc absorption. The addition of exogenous phytases is an efficacious~     strategy to reduce the phytate content of foods, and increase the bioavailability of dietary~     zinc; however, the efficacy of this approach has not yet been demonstrated for SQ-LNS.~      Objective: The overall objective of the study is to assess the efficacy of adding exogenous~     phytase to SQ-LNS by investigating intra-individual differences in the fractional absorption~     of zinc (FAZ) among children who receive additional dietary zinc (8 mg/d) from SQ-LNS with or~     without phytase.~      Trial approach: The study will be a double-blind randomized controlled clinical trial,~     designed to permit within-child comparisons of zinc absorption from SQ-LNS, with or without~     exogenous phytase, by using the triple stable-isotope ratio tracer technique. The clinical~     study will enroll 34 children between the ages of 18-23 months. The main outcome of interest~     is the intra-individual difference in the FAZ from porridge-based meals containing SQ-LNS~     with and without phytase. Up to an` additional 36 children will be enrolled in a pilot~     feeding study to determine portion sizes of study meals.~      Trial setting: Keneba, The Gambia~      Trial interventions:~      The SQ-LNS (20g) used in this study will be provided by Nutriset, S.A.S. The exogenous~     phytase (DSM phytase Tolerase 20000G) is derived from Aspergillus niger; phytase will be~     added to the SQ-LNS during the production phase, and will be enzymatically active in vivo at~     the time of consumption.~      Feeding Protocol and Study Diet: The study diet for the 2day absorption study will consist of~     the following: 1) Two stable-isotope labeled test meals per day (porridge made from locally~     procured non-fermented cereal, mixed with 10 g of SQ-LNS), with children randomized to~     receive either SQ-LNS with phytase or SQ-LNS without phytase on the first day and the~     alternative product on the second; 2) One additional standardized meal per day (e.g. rice~     with sauce); 3) Low-zinc, low-phytate food (e.g. bananas) consumed ad libitum if requested~     (with the exception of 1 hour before and 2 hours after each test meal). Children will be fed~     by their caregivers under supervision by a study fieldworker. The SQ-LNS product (without~     phytase) will be provided to children twice per day for one day prior to the start of the~     stable isotope absorption studies, in order to habituate children to the study diet and~     location. Children will attend the study clinic daily for four days and will be enrolled in~     the study for a total of ten days.~      Zinc absorption studies: The FAZ of zinc will be measured by a triple-isotope tracer ratio~     technique, using orally administered extrinsic labels (Zn-67 and Zn-70) and intravenous~     Zn-68. Urine samples, collected pre- and post-isotope administration (d 1, 5-9) will be~     analyzed for zinc isotope ratios by ICP-MS. FAZ will be calculated based on the mean isotopic~     ratios obtained from the enriched urine samples, and based on the tracer:tracee ratio method.~     TAZ will be calculated by multiplying FAZ by total zinc intake from the test meals.~      Data Collection: The following information will be collected from each subject: brief medical~     history; physical examination; weight and height; daily morbidity and pre-intervention blood~     sampling for hemoglobin, complete blood count and plasma zinc concentration, malaria and~     systemic inflammation (C-reactive protein and α-1-acid glycoprotein).~   "
68668|NCT02668120|"~     Background : Chronic histiocytic intervillositis is a rare placental disease linked with poor~     perinatal outcome. In a recent study, a major antenatal increased alkaline phosphatase was~     suspected in patients affected by chronic histiocytic intervillositis. This increase may~     correspond to the release of alkaline phosphatase by the syncytiotrophoblaste prejudiced in~     this pathology.~      Aim : To confirm the association between high levels of alkaline phosphatase and the~     occurrence of chronic histiocytic intervillositis.~   "
68669|NCT02668107|"~     To compare and analyze the effects on the electromyographic activity of preterm newborns~     placed in the hammock position with the activity of newborns not placed in this position.~   "
68670|NCT02668094|"~     Pain is a common side effect of propofol injection. The purpose of this study was to compare~     the efficacy of pregabalin and lidocaine in reducing propofol injection pain.~   "
68671|NCT02668081|"~     This study compares the effect of endoscopic sphincterotomy and endoscopic papillary balloon~     dilation in the treatment of acute biliary pancreatitis.Participants with acute biliary~     pancreatitis will be randomized into either the endoscopic sphincterotomy or endoscopic~     papillary balloon dilation groups.Moreover, the investigators compare the results obtained~     from the traditional bile/blood culture and metagenomics.~   "
68672|NCT02668068|"~     Pneumoconiosis is a kind of lung disease due to inhalation of dust such as silica(common~     named Silicosis), coal and rock dust, characterized by inflammation, coughing, and fibrosis.~     Currently there is no effective drug treatment. The whole-lung lavage(WLL) can effectively~     clear the protein-like substances and inhaled dust deposited in the alveoli and bronchioles,~     as well as the pulmonary alveolar macrophage(PAM) and the resulting induced inflammation,~     fibrosis induced factor, serve to improve respiratory function, relieve symptoms of efficacy,~     but can't slow down or reverse the progression of pulmonary fibrosis.~      By taking large volume whole-lung lavage (WLL) as a conventional therapy, this study intends~     to observe and evaluate the safety and efficiency of combined large volume WLL with~     mesenchymal stem cell (MSC) transplantation for treatment of Pneumoconiosis. Moreover, the~     immune regulation effect between large volume WLL and combined large volume WLL with MSC~     transplantation will also be preliminarily investigated and discussed.~   "
68676|NCT02668016|"~     Front-line clinicians cannot currently test for an individual participant whether symptoms~     experienced are the pharmacological result of a statin or due to other phenomena. In this~     trial, participants who have previously ceased statins due to side effects will be offered~     the opportunity to undergo twelve randomly ordered 1-month periods. There will be four~     periods of no medication, four periods of placebo and four periods of statin. The placebo and~     the statin pills will be identical in appearance. Participants will record on a daily basis~     side-effects experienced. At the end of the study, the one-month sessions are sorted into the~     order shown above. The participant can then observe directly how much of the increase in~     symptoms seen with statin is also seen with placebo.~        1. Hypothesis 1: that >30% of participants enrolling for the study will complete it.~        2. Hypothesis 2: Overall >50% of symptom burden is nocebo rather than pharmacological~        3. The investigators will define the Nocebo proportion of side effects.~        4. Hypothesis 3: that the majority of participants, at 6 months after completion, will~          either be taking statins or have declined statins for reasons other than perceived side~          effects.~   "
68677|NCT02668003|"~     It is known from many studies that when patients have developed chronic widespread pain (CWP)~     or fibromyalgia that managing such symptoms is extremely challenging for both doctors and~     patients. The investigators have shown in a recently completed study funded by Arthritis~     Research UK that a course of Cognitive Behaviour Therapy delivered by telephone (tCBT) or an~     exercise regime can substantially improve the chances of the symptoms improving. The~     investigators now plan to offer this therapy to patients who are at a high risk of developing~     CWP (but who have not developed it yet) to see whether its onset can be prevented.~   "
68678|NCT02667990|"~     22 women Testing orthopedic stilettos compared to standard stilettos and a comfy trainer.~      Testing involves pedobar pressures and a validated comfort questionnaire.~   "
68679|NCT02667977|"~     The study aim is to isolate a single type of patient (pediatric patient with acute~     gastrointestinal symptoms) and evaluate the use of hypotonic (0.45 NS) vs. isotonic (0.9 NS)~     fluids in these patients in regards to changes in their serum sodium and iatrogenic~     hyponatremia.~   "
68680|NCT02667964|"~     FGF-21 and insulin are key hormones in the regulation of glucose metabolism. Furthermore,~     both hormones are influenced by physical activity. The following hypothesis will be tested:~     FGF-21 is regulated insulin-dependent during exercise.~   "
68681|NCT02667951|"~     The illness course and symptoms of dementia is usually very long and characterized with~     behavioral, psychological and physical changes. Family caregivers' stresses change during the~     illness trajectory as well. The purpose of this study is to compare the costs and~     effectiveness of two care models- home-based caregiver-training program model and routine~     care model for dementia elders in Taiwan.~   "
68682|NCT02667938|"~     The main objective of this study is to evaluate efficacy and safety of HCP1301 capsule in~     patients with Benign Prostatic Hyperplasia and Erectile Dysfunction~   "
68683|NCT02667925|"~     The treatment of advanced ovarian cancer is based on the combination of chemotherapy based on~     platinum salt and surgery whose quality is the major prognostic factor.~      A meta-analysis of retrospective series had shown that for every 10% increase in the complete~     cytoreduction rates were increased by 5.5% overall survival time (Markman et al, 2001).~     Currently, it is recognized that the best chance of survival conferred to patients whose~     initial surgical residue is zero (Harter et al, 2009).~      However, even if macroscopically complete surgery and whatever the type of systemic~     chemotherapy, peritoneal recurrence remains high for more than 75%.~      To reducing it of recurrence, a therapeutic approach is to administer chemotherapy~     intraperitoneally.~      The intraperitoneal chemotherapy consists to administer the drug directly into the peritoneal~     cavity.~      Alberts et al, 1996 and Armstrong et al, 2006 compared the efficacy in terms of survival of~     an intraperitoneal chemotherapy according to this method with a conventional systemic~     chemotherapy. Alberts reported a significant improvement in the median overall survival.~     Armstrong shows in addition a decreased risk of recurrence.~      It must be remembered that:~        -  The establishment of an intra-abdominal catheter does not always ensure complete flow of~          drugs into the peritoneal cavity (major postoperative adhesions).~        -  There may be problems of catheters becoming blocked and requiring local treatment; these~          problems can cause abdominal pain whose care is difficult. Thus almost half of patients~          fail to get all six courses of intraperitoneal chemotherapy.~      Thus, the investigators propose to estimate the flow of intraperitoneal chemotherapy with IP~     peritoneal scintigraphy, using a radiotracer (nanocis®). The investigators hypothesize that~     the movement of colloids in peritoneal cavity is similar to the circulation of chemotherapy~     within the peritoneal cavity (From Forni et al, 1993, Varia et al, 2003, Young et al, 2003,~     Dawson et al, 2011). The accumulation of radiotracer will be more correlated with abdominal~     pain sites described by the patient as well as peritoneal recurrence sites found during~     monitoring.~   "
68684|NCT02667912|"~     Objective of this study is to evaluate whether a distal mode of endovascular renal~     denervation with the treatment performed primarily in segmental branches of renal artery is~     more effective than conventional mode of the intervention with the treatment equally~     distributed within its main trunk for the treatment of drug-resistant hypertension.~   "
68685|NCT02667899|"~     Aims:To explore the consciousness stimulation role of DBS (Deep Brain Stimulation) and TMS~     (Transcranial Magnetic Simulation) for DOC (Disorders of Consciousness) patients.~      Methods:Seventy-five DOC patients will be randomised into three groups: DBS group, TMS group~     and Control group. Three months after treatments, the result will be analysed and concluded.~   "
68686|NCT02667886|"~     The purpose of the study is to test different doses of X4P-001 given alone and in combination~     with axitinib in patients diagnosed with advanced renal cell carcinoma. The goals of the~     study are to determine the safety and tolerability of X4P-001, as well as the potential~     effect it may have on the body and the cancer tumor.~   "
68687|NCT02667873|"~     Study SL-801-0115 is a dose-escalation study evaluating multiple doses and schedules of~     orally administered SL-801 in patients with Advanced Solid Tumors~   "
68688|NCT02667860|"~     The creation of an intracorporeal anastomosis during right hemicolectomy is regarded as~     superior than the extracorporeal anastomosis in terms of recovery of peristalsis, aesthetic~     results, analgesia requirements and length of hospital stay. The objective of this study is~     to compare the postoperative results of intracorporeal versus extracorporeal anastomosis in~     patients undergoing laparoscopic right hemicolectomy.~   "
68689|NCT02667847|"~     Preoperative anxiety is a complex clinical concept with both physiological and psychological~     consequences.~   "
68690|NCT02667834|"~     Social cognition and interaction training (SCIT), a group-based treatment that aims to~     improve both processing social information and functioning, may be an effective treatment for~     enhancing the social skills of people with schizophrenia. This study will compare the~     effectiveness of Social cognition and interaction training (SCIT) versus treatment as usual~     (ETP) in helping people with schizophrenia improve their social cognition and social~     functioning so specially on negative symptoms. Many studies show a connection between~     negative symptom and social cognition in schizophrenia.~   "
68693|NCT02667795|"~     It is generally accepted that physically fit patients cope much better with the stress of~     surgery and recover faster. Consequently several research studies have tried to increase~     people's level of fitness before they have surgery. These previous research studies have~     usually required patients to carry out intense, structured exercise programmes that involve~     going to a gym. However such programmes are not 'user friendly' especially if people are not~     used to taking a lot of exercise. In this pilot study we want to test the feasibility of a~     home based programme that tries to increase patients' level of fitness by gradually~     increasing the number of steps they walk every day.~      Participants will be randomised into one of two groups. One group of participants will be~     asked to increase their level of activity by gradually walking further (the exercise group)~     and the other group will carry on with their usual level of activity (the usual activity~     group) .~      Assessments People in both groups will have an assessment on 3 occasions: when they join the~     study, just before surgery and 3 months after surgery.~      This assessment involves:~      Walking for 6 minutes up and down a corridor to see how far they can walk. Asking them for~     some information about their medical history Completing three questionnaires about how they~     are feeling and their quality of life.~      People who are randomised to the exercise group will be advised about how many steps to take~     based on how they did in the initial walking assessment. The number of days or weeks they~     will be asked to take a daily walk will depend on how much time there is between them joining~     the study and the date of their surgery. We think this will be about 2 weeks.~   "
68694|NCT02667782|"~     The aim of this study is to examine which mindfulness-based intervention protocol, MBCT or~     MBSR, is more suited for use among local carers of people with dementia (PWD), as measured by~     better mental health outcomes in PWD such as reductions in stress and improvements in mental~     well-being.~   "
68695|NCT02667769|"~     This is a prospective study with a crossover design, where fasting with a day of complete~     fasting and a fasting day with the permission intake of calories- and carbohydrate-free foods~     are compared in a randomized order. Underlying hypothesis is that at the same basal insulin~     substitution with the fasting of both protocols , no significant differences in the~     glucose-day or -night profiles revealed. So the same conclusions regarding the consistency~     of basal insulin dosing revealed during the implementation of the part of patients is rated~     as more pleasant when calories and carbohydrates-free food are allowed.~   "
68696|NCT02667756|"~     This observational study seeks to identify and validate novel soluble biomarkers (within~     blood, synovial fluid, urine) which contribute to the prognostic assessment of an individual~     with an acute knee injury, a group of individuals in which ~50% will progress to symptomatic~     radiographic knee osteoarthritis (OA).~      150 individuals will be followed over 5 years with clinical assessment including validated~     questionnaires, biological sampling and radiological imaging (X ray, magnetic resonance~     imaging (MRI)).~   "
68697|NCT02667743|"~     An open-label randomized and controlled clinical trial: This study was to compare the~     anticancer efficacy and safety in the First-Line Treatment in patients with Advanced~     Non-Small-Cell Lung Cancer with Paclitaxel Micelles for Injection In combination with~     Cisplatin versus Paclitaxel Injection Containing Cremophor EL(polyoxyethylenated castor oil)~     In combination with Cisplatin in the way of an open-label, randomized controlled clinical~     trial.~      Treatment Protocol:~      The subjects were randomized in the Paclitaxel Micelles for Injection Group and the~     Paclitaxel Injection Group by the proportion of 2:1. The centralized randomization method was~     adopted in this trial. Since the study was a comparison of first-line treatment, the test for~     superiority was adopted. The objective response rate was the primary indicator of efficacy in~     this study.~      Trial Group:~      Paclitaxel Micelles for Injection and Cisplatin was intravenously administrated. Three weeks~     constituted one course of treatment.~      No pretreatment, including anti-allergic prevention and antiemetic prophylaxis, was required~     for the patients before infusion of Paclitaxel Micelles for Injection patients.~      Control Group:~      Conventional Paclitaxel Injection and Cisplatin was intravenously administrated. Three weeks~     constituted one course of treatment.~      Standard preventive treatment must be given to patients in accordance with the specific~     requirements in specifications of Paclitaxel Injection.~      Regardless of the Trial Group or the Control Group, six treatment periods shall be the upper~     limit.~      To estimate the sample size based on objective remission indicators (CR + PR) in the study.~     Hypothesis: the objective remission rate of the Paclitaxel Micelles for Injection combined~     with Cisplatin in the Trial Group is different with that of first-line treatment of advanced~     non-small cell lung cancer, and is also different with that of the Cremophor EL-containing~     Paclitaxel Injection combined with Cisplatin in the Control Group. Trial parameter settings:~     assuming α = 0.05 and 1-β = 80%, the Trial Group: Control Group is designed as per the~     proportion of 2: 1. According to the sample size formula , a total of 426 patients is~     required, including 284 patients assigned in the Trial Group and 142 in the Control Group. In~     consideration of case expulsion in the process of clinical, enlarged by 10%, actually 468~     cases were included in the groups, including 312 in the Trial Group and 156 in the Control~     Group.~   "
68698|NCT02667730|"~     In this 4-arm pragmatic randomized control trial, the investigators hope to decipher whether~     the use of non-opioid analgesics (naproxen, celecoxib, acetaminophen) in addition to~     standardized physiotherapy during the acute phase of grade I-II ankle injuries will result in~     functional differences compared to standardized physiotherapy alone~   "
68699|NCT02667717|"~     AlgoMIR project born thanks to a meeting between pain professionals and re-education staff.~     The goal of this project is to develop and evaluate a program of learning with exercises by~     mirror therapy, that could be easily shared with paramedic teams and easily adapted to~     different handicaps.~      Researchers have chosen to select patients with re-education of the upper extremity to~     benefit from rehabilitation sessions either from physiotherapists present in their city, or~     of functional rehabilitation hospital units.~   "
68700|NCT02667704|"~     The trial was designed to investigate whether, and to which extent, multiple doses of~     bosentan may influence the plasma levels of nintedanib administered as a single dose.~   "
68701|NCT02667691|"~     The objective of this study is to evaluate the influence of a 3 months SODB® supplementation~     in adipose tissue modulations of overweight women, in comparison to a placebo.~   "
68702|NCT02667678|"~     The aim of this study is to compare the biomarkers levels as IL-18, KIM-1 and Cystatin C for~     patients infected by HIV with failure in renal function at year 5. The main criterion will be~     a degradation of the glomerular filtration throughput measured. It will be compared to~     clinical scores of degradation risks of renal function for patients infected with HIV.~   "
68703|NCT02667665|"~     Examine the construct validity, the test-retest reliability, the concurrent validity with the~     standard dementia rating scales and the reactivity of a novel dementia rating scale QuQu~     scale: QUick QUestion scale final for the evaluation of patients with Alzheimer's Disease~     Dementia and Mild Cognitive Impairment.~   "
68704|NCT02667652|"~     The purpose of this study is to investigate the curative effect of the length of the jejunum~     exclusion in gastric surgry for T2DM and metabolic syndrome,and to draft Scientific and~     reasonable operation parameters.~   "
68705|NCT02667639|"~     The purpose of this fist in human study is to evaluate the safety and tolerability of RPH-104~     in humans.~   "
81824|NCT02495922|"~     Trial in patients with newly diagnosed myeloma to evaluate the effect of elotuzumab in~     induction and consolidation therapy with bortezomib/lenalidomide/dexamethasone and in~     lenalidomide maintenance treatment~   "
68706|NCT02667626|"~     The investigators propose to test the efficacy of the Reproductive Health Survivorship Care~     Plan (SCP-R), a novel survivorship care tool to meet the reproductive health needs of young~     breast cancer survivors (YBCS). Most YBCS undergo chemotherapy and/or endocrine therapy,~     treatments that impair ovarian function and result in significant reproductive health late~     effects. These late effects include symptoms of estrogen deprivation such as hot flashes,~     fertility concerns, limited contraception options and sexual problems. Together they have a~     major, negative impact on quality of life.~      Despite substantial research, treatment guidelines and clinical expertise on these issues,~     most YBCS and their healthcare providers have limited guidance on how best to manage these~     reproductive health late effects. The research team has generated a practical, accessible,~     evidence-based reproductive health survivorship care plan (the SCP-R) for YBCS and their~     providers to address this deficit in survivorship care. This clinical trial will test if YBCS~     who receive the web-based SCP-R are more likely than controls to improve on at least one of~     these reproductive health issues: hot flashes, sexual health, fertility concerns, and~     contraception.~   "
68707|NCT02667613|"~     Studying in a RCT the changes in everyday llife activities of children with CP during~     HABIT-ILE or control period, changes being scored by parents and by experts.~   "
68708|NCT02667600|"~     The aim of this study is to assess the ability of the Triton Device to measure blood loss~     among women undergoing elective and non-elective cesarean delivery. This patient population~     often experiences significant blood loss during surgery, and measurements of surgical blood~     loss are often inaccurate.~   "
68709|NCT02667587|"~     The purpose of this study is to evaluate patients with glioblastoma that is MGMT-methylated~     (the MGMT gene is altered by a chemical change). Patients will receive temozolomide plus~     radiation therapy. They will be compared to patients receiving Nivolumab in addition to~     temozolomide plus radiation therapy.~   "
68710|NCT02667574|"~     Open-label, non-comparative, multicenter, phase II study of Vismodegib in patients with~     locally advanced BCC.~   "
68711|NCT02667561|"~     This is a Phase I, open-label, parallel trial to evaluate Pharmacokinetics, Pharmacodynamics~     and Safety of Testosterone gel 1% for topic usage in post-menopausal women, for 28 days~   "
68712|NCT02667548|"~     Coronary heart disease (CHD) has a serious health threaten to population. PCI is a~     well-proved measure in CHD management. However, the knowledge about the real-life PCI use and~     how evidence-based therapies in routine clinical practice is limited. By consecutively~     recruiting PCI patients in a large-scale hospital in in Northeast China,this study will~     examine various real-life factors, that may affect patients recovery after the procedure.~     Practical guidelines, appropriateness criteria and quality evaluative system for PCI will be~     established based on the findings, to improve patients outcomes in future finally.~   "
68713|NCT02667535|"~     This is a Phase I trial to evaluate Pharmacokinetics, Pharmacodynamics and Safety of~     Isosorbide Mononitrate gel for usage in participants with anal fissure and healthy~     volunteers. Three doses will be used in patients with anal fissure (0.5%, 1.0% or 2.0%) and~     healthy volunteers will receive 2.0% dose. All treatment will last 7 days.~   "
68714|NCT02667522|"~     The purpose of this study is to test causal links between dimensions of positive and harsh~     parenting and children's brain responses to rewards and errors, using a parenting~     intervention.~   "
68715|NCT02667509|"~     Myopia has emerged as a major health issue in east Asia, because of its increasingly high~     prevalence in the past few decades (now 80-90% in school-leavers), and because of the~     sight-threatening pathologies associated with high myopia, which now aff ects 10-20% of those~     completing secondary schooling in this part of the world. Similar, but less marked, changes~     are occurring in other parts of the world. The higher prevalence of myopia in east Asian~     cities seems to be associated with increasing educational pressures, combined with life-style~     changes, which have reduced the time children spend outside.~   "
68716|NCT02667496|"~     Primary Objective:~      To compare the effect of repeat doses of Leukine to placebo administered subcutaneously (SC)~     on established cortical amyloid load in patients with mild cognitive impairment (MCI) due to~     Alzheimer's disease (AD).~      Secondary Objective:~        -  To evaluate safety and tolerability of Leukine versus placebo.~        -  To explore the effect of Leukine versus placebo on cognitive performance.~        -  To collect biospecimens for future biomarker research.~   "
68717|NCT02667483|"~     This is a phase I/II study to evaluate the safety, tolerability, efficacy, and~     pharmacokinetic (PK) profile of DS-5141b in patients with Duchenne muscular dystrophy (DMD)~     amenable to exon 45 skipping and to determine the dosage for subsequent studies.~   "
68718|NCT02667470|"~     The objective of this study is to evaluate change of Overactive Bladder (OAB) Symptom Score~     (OABSS) scores between before and after Solifenacin treatment to OAB patients and to evaluate~     correlation between change of OABSS scores and other measures for OAB symptoms.~   "
68719|NCT02667457|"~     The study is being done to assess the ability of the radiotracer 99mTc-rhAnnexin V-128 to~     image atherosclerotic plaque that may rupture and break off artery walls. This is caused by~     apoptosis or cell death in the plaque. These ruptured plaques can block blood circulation in~     the arteries causing a lack of oxygen to the tissues. Atherosclerotic plaques can build up on~     any artery in the body.~   "
68720|NCT02667444|"~     This is a 12 week, multi-center, double-blinded, randomized, vehicle-controlled, parallel~     group, study to be conducted in approximately 1300 subjects with acne vulgaris in the US.~   "
68721|NCT02667431|"~     Concurrent treatment of endometrial cancer and SUI may improve QOL, emotional and physical~     health and decrease costs for both patients and the health care system. At the time of~     endometrial cancer diagnosis, not only are women evaluated by a gynecologist and/or a~     gynecologic oncologist, but the majority will undergo surgery within weeks of their~     diagnosis. Thus, urinary incontinence could easily be identified, a referral made, and~     concurrent surgery performed. This would spare the patient two surgeries, decrease the~     emotional distress associated with SUI symptoms, decrease the costs associated with SUI for~     the patient and possibly improve overall quality of life. The proposed study will compare the~     quality of life and clinical outcomes among women with endometrial cancer and SUI that have~     concurrent surgery to women that do not have concurrent surgery. The findings of our proposed~     research will provide valuable information necessary for woman and clinicians to make~     decisions regarding the treatment of SUI, including evidence regarding the risks and benefits~     of performing concurrent endometrial cancer and SUI surgery.~   "
68723|NCT02667405|"~     This study investigates the effect of hot packs versus whirlpool and exercise for patients~     with distal radius fracture (DRF). Patients with recently healed DRF are randomized into two~     groups, with one group receiving hot packs during therapy and the other immersing the arm in~     a whirlpool for 3 consecutive therapy visits. The effect of these modalities on range of~     motion and volume of the hand are evaluated, with measurements taking place before and~     immediately after heat during each visit.~   "
68724|NCT02667392|"~     Approximately 15,000 Veterans are hospitalized for stroke each year with new cases costing an~     estimated $111 million for acute inpatient, $75 million for post-acute inpatient, and $88~     million for follow-up care over 6 months post-stroke. Rehabilitation of walking ability~     contributes to these costs. To walk again is the number one stated goal for Veterans who~     have had a stroke. Teaching patients post-stroke to use their weak leg while they are~     regaining walking function and to not compensate by over-using their strong leg is necessary~     to restore safe, efficient walking ability. This project will determine if providing~     biofeedback (an audible tone) from pressure-sensitive shoe insole sensors, that encourage use~     of the weaker leg during walking training, in addition to therapists' feedback, will help~     Veterans regain use of their weak leg, improve their endurance and improve their balance when~     walking in challenging environments.~   "
68725|NCT02667379|"~     Determination of allergenicity of cat dander samples obtained before and after vaccinating~     the cat~   "
68726|NCT02667366|"~     The aim of the study is the examination of effectiveness and cost-effectiveness of a~     telephone-based psychotherapy (Tel-PT) for depression compared to treatment as usual in~     primary care.~   "
68727|NCT02667353|"~     To study the potential neurorestorative effects of electroconvulsive therapy (ECT) in~     depressed patients by measuring brain derived neurotrophic factor (BDNF) serum levels and~     hippocampal volumes in severely depressed patients receiving ECT.~   "
68728|NCT02667340|"~     To assess the efficacy of a hydrothermally modified starch supplement (Superstarch made~     byGeneration UCAN) vs isoenergetic placebo (glucose) on exercise performance, execution of~     specific soccer skills, and on cognitive function during and following a simulated soccer~     game.~      Secondary: To compare fat oxidation and carbohydrate oxidation (based on RER data) during the~     game with Generation UCAN vs isoenergetic placebo (glucose).~   "
68729|NCT02667327|"~     The purpose of this study is to determine whether Granexin gel is safe and effective in the~     treatment of diabetic foot ulcers.~   "
68730|NCT02667314|"~     Meta-analyses indicate beneficial effects of cognitive training and cognitively challenging~     video games on cognition. However, cognitive effects of solving jigsaw puzzles - a popular,~     visuospatial cognitive leisure activity - have not been investigated, yet. Thus, the primary~     aim of this study is to evaluate the effect of solving jigsaw puzzles on visuospatial~     cognition. As secondary aims, effects on psychological outcomes (self-efficacy, perceived~     stress, well-being) and visuospatial everyday functioning (instrumental activities of daily~     living and self-reported cognitive failures in everyday life) are examined.~   "
68731|NCT02667301|"~     The purpose of the study is to understand the exact mechanism of the activity of paratubal~     muscles in opening eustachian tube in patients with the functional eustachian tube and those~     with the eustachian tube dysfunction problem.~   "
68732|NCT02667288|"~     This is an open-label safety study. During this study, the investigator will identify 4~     eligible SK Target Lesions on each subject on the trunk, extremities and face.~   "
68733|NCT02667275|"~     This is a randomized, double-blind, vehicle-controlled, parallel group study.~   "
68734|NCT02667262|"~     The purpose of this study is to develop and validate a classification model based entirely on~     medical claims data that can be used to identify patients experiencing prescription opioid~     abuse/addiction among patients receiving extended-release (ER) and/or long-acting (LA)~     opioids~   "
68735|NCT02667249|"~     Compliance to the clinical pathway, postoperative complication and total cost of the~     hospitalisation of patients undergoing elective cholecystectomy for symptomatic~     cholecystolithiasis were collected over two different periods: using a clinical pathway in~     form of a paper based check-list (group 1, n=118) or a clinical pathway integrated into the~     paper based medical treatment and nursing documentation (group 2, n=123). Outcome measures~     were compliance of the clinical pathway and total costs per case.~   "
68736|NCT02667236|"~     This is a randomized, double-blind, vehicle-controlled, parallel group study of A-101~     Solution 40% compared with Vehicle Solution.~   "
68737|NCT02667223|"~     This is a Phase 1, open-label, single-dose, randomized, dose escalation study in healthy and~     hypercholesterolemic subjects. Each subject will receive 1 of 5 treatments as a single~     subcutaneous injection. Subjects will remain confined at the research clinic for~     approximately 2 days. After discharge, subjects will return to the research clinic 15 times~     during 12 weeks.~   "
68738|NCT02667210|"~     To assess whether the percentage of patients with behaviors suggestive of misuse, diversion,~     abuse and/or addiction described in the medical record increases across pre-defined~     categories of increasing doctor/pharmacy shopping behavior.~   "
68739|NCT02667197|"~     The purpose of this study is to determine reliability of codes and data from electronic~     medical records to predict and measure overdose and death in patients prescribed opioid~     analgesics. The study will compare this electronic data to data manually obtained from~     medical charts.~   "
68740|NCT02667184|"~     The goal of this study is to determine subjective gastrointestinal tolerance response and~     differences in breath hydrogen response following the consumption of different types of low~     FODMAP oral nutrition supplements. This randomized, crossover study requires participants to~     arrive to the lab 12 hours fasted, consume an oral liquid supplement and complete~     gastrointestinal tolerance questionnaires as well as produce samples for breath hydrogen~     analysis at various time points over a 4 hour time period.~   "
68762|NCT02666898|"~     Phase II study testing chemo-free induction therapy with Ibrutinib + Obinutuzumab nine months~     /~      Study Part 1:~      All patients will receive 8 courses of GA101 + ibrutinib 420mg PO every 28 days~      Study Part 2:~      After evaluation at D1 of month 9:~      If patients are in CR with BM MRD < 10-4, they will continue ibrutinib alone at a dose of~     420mg daily If patients have BM MRD >10-4 whatever IWCLL 2008 responses or PR they will~     receive four courses of GA101 + FC at 28-day intervals + Ibrutinib PO until final evaluation~     of M16~   "
68741|NCT02667171|"~     International and national publications emphasize that COPD rehabilitation is a key~     cornerstone in the standard treatment of COPD, based on more than 15 years of research in~     COPD rehabilitation. COPD rehabilitation improves quality of life, anxiety and depression and~     physical function. COPD rehabilitation including special physical training, patient-directed~     education and smoking cessation is core rehabilitation elements, which today are recommended~     as mandatory content in standard COPD rehabilitation.~      Standard COPD rehabilitation is an established offer in all regions and municipalities in~     Denmark. It is however a well-known challenge, that persons with the most severe COPD~     symptoms and co-morbidities are most likely not to receive COPD rehabilitation. Frequent~     exacerbations, socially isolation, transport distance to rehabilitation are main reasons why~     people with severe COPD disease deliberately chooses not to receive COPD rehabilitation. Why~     there at present are no rehabilitation alternatives for patients with the most severe COPD~     symptoms, supervised COPD Online rehabilitation in groups, delivered by health professionals~     in the COPD patients' own home via a computer screen could likely encourage more people to~     participate. The number of RCT's investigating the effect of supervised Online delivered COPD~     rehabilitation in groups versus established COPD rehabilitation are very limited.~      The purpose of this randomized study is to investigate the short-term and long-term efficacy~     of 10 weeks of online COPD rehabilitation versus conventional supervised COPD rehabilitation~     in people with severe and very severe COPD. The outcome of the intervention is measured on~     walking distance, muscle endurance, activity level, quality of life and COPD symptoms~     respectively. Outcomes are measures before intervention start, end of intervention. This~     study also collects follow-up update after 3, 6 and 12 month. The follow-up data will be in~     separate publication.~      Hypothesis~        1. COPD online rehabilitation provides significant larger improvements than the usual care~          on walking distance, muscle endurance, activity level, and quality of life and COPD~          symptoms in people with severe and very severe COPD.~        2. COPD online rehabilitation and conventional COPD rehabilitation, provides clinically~          relevant improvement on walking distance, muscle endurance, activity level, quality of~          life and COPD symptoms in people with severe and very severe COPD.~   "
68742|NCT02667158|"~     To evaluate the reasons patients go to more than one prescriber or more than one pharmacy to~     obtain prescriptions opioids and assess whether the percentage of patients reporting misuse,~     abuse and/or diversion increases across defined categories of doctor/pharmacy shopping as~     defined in Study 4A.~   "
68743|NCT02667145|"~     Randomized clinical trial , blind for evaluators, to assess the effectiveness of a self-care~     program using assistive technology for treatment of hand osteoarthritis.~   "
68744|NCT02667132|"~     The aim of this study was to retrospectively review the granulomatous mastitis and evaluated~     current approach and treatment.~      HYPOTHESIS Although there is no common protocol for the treatment and management process of~     GM, the ternary treatment (medical treatment following by surgical procedure,~     Steroid+Antibiotic and surgical procedure, respectively) is considered as the most successful~     treatment approach.~   "
68745|NCT02667119|"~     The purpose of the study is to determine the safety and efficacy of an integrated treatment~     for substance abuse and posttraumatic stress disorder for young adults. The integrated~     treatment includes two established psychosocial treatments for substance abuse (Contingency~     Management) and posttraumatic stress disorder (Prolonged Exposure therapy).~   "
68746|NCT02667106|"~     This Phase I study is to examine the systemic pharmacokinetics of RX0041-002 following acute,~     topical, intranasal administration to healthy male and female volunteers.~   "
68747|NCT02667093|"~     The purpose of this project is to develop a process to identify highly personalized antigens~     that are uniquely expressed by the patient's own leukemia cells that can be used for cellular~     immune therapy.~   "
68748|NCT02667080|"~     The main purpose of the study is to assess to which degree a series of sperm parameters known~     to be associated with fertilization and implantation potential in artificial reproductive~     technology (ART) differ in consecutive sperm samples produced after 2-7 days and 2 hours of~     sexual abstinence in males from couples referring for ART treatment.~   "
68749|NCT02667067|"~     This study is intended to demonstrate that the Simplify® Disc is at least as safe and~     effective as conventional anterior cervical discectomy and fusion (ACDF) when used to treat~     one level between C3 to C7 for cervical degenerative disc disease (DDD) defined as~     intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain~     or myelopathy due to a single-level abnormality localized to the level of the disc space in~     subjects who are unresponsive to conservative management.~   "
68750|NCT02667054|"~     To determine if RX0041-002 is a safe and effective topical anesthetic.~   "
68751|NCT02667041|"~     Major depressive disorder (MDD) is a debilitating illness that affects millions of~     individuals in North America and can result in clinical symptoms including loss of pleasure~     and feelings of worthlessness, in addition to significant cognitive impairments (e.g.,~     memory, attention) that affect daily functioning. Major depression bears a heavy burden for~     the individuals and family members afflicted, as well as an enormous health care and economic~     cost. Approximately half of major depressive patients seek out treatment for their illness~     and only 20% of those individuals report their treatment as satisfactory. Many MDD patients~     do not respond to pharmacological therapy following the first course of treatment, resulting~     in the need for alternative measures to alleviate the clinical and cognitive symptoms of~     treatment-resistant depression and the targeting of these therapies to better suit each~     individual patient. Repetitive transcranial magnetic stimulation (rTMS) is a well-accepted,~     non-invasive technique that utilizes currents to induce electrical fields that excite~     specific brain regions. The current recommended practice of rTMS involves the administration~     of a biphasic stimulus waveform; however, a novel method using monophasic pulses may prove~     more effective for the treatment of depression. The present study aims to determine the~     effect of monophasic rTMS compared to biphasic rTMS on cognitive processing in MDD patients~     through electrophysiological recordings of the brain taken before and after 6 weeks of~     stimulation. Additionally, the study aims to investigate various biological markers linked to~     clinical rTMS response; these brain markers will help in personalizing treatment for~     individuals suffering from MDD.~   "
68752|NCT02667028|"~     Coronary heart disease (CHD) has a serious health threaten to population. PCI is a~     well-proved measure in CHD management. However, the knowledge about the real-life PCI use and~     how evidence-based therapies in routine clinical practice is limited. In a large-scale~     hospital in Northeast China, the investigators will examine various factors of 3007~     consecutive PCI inpatient cases from January 1, 2010 to October 31, 2014. The medical records~     will be reviewed and abstracted to evaluate the clinical treatment pattern and outcomes.~     Basic data and innovative evidence will accelerate evidence-based clinical practice, and~     improve patients' outcomes in future finally.~   "
68763|NCT02666885|"~     The current trial is evaluating the integration of a pretherapeutical FDG-PET/MRI in the~     adjuvant radiochemotherapy in patients with head and neck cancer. As a secondary hypothesis~     the intention is to develop of a multi-parametric decision support system for personalised~     medicine by integrating functional imaging, γH2AX-analysis and genetic information.~   "
71532|NCT02630615|"~     The primary objective of this study is to establish circulating tumor cell (CTC) derived~     xenografts and assess the activity of novel DNA repair inhibitors as a function of DNA repair~     mutations detected in CTC samples (personalize DNA repair therapy).~   "
68753|NCT02667015|"~     The aim of the current study is to develop and pilot test an anxiety sensitivity-based~     intervention for co-occurring substance use disorders (SUDs) and anxiety. Research questions~     include determining whether a broadly-applicable AS-based intervention can significantly~     decrease both substance misuse and anxiety. Secondary aims include examining the impact of~     this intervention on general functioning and depressive/anxious symptoms. In phase I, an~     initial pilot was conducted to examine the feasibility, safety, and patient satisfaction with~     the protocol, and to estimate potential efficacy of the protocol. In phase II, participants~     will be randomized to the intervention or a control condition.~   "
68754|NCT02667002|"~     Investigators separated 20 patients with uterovaginal prolapse into 2 groups according to~     random numbers table. In one group, conventional abdominal sacral hysteropexy will be perform~     and another group bilateral abdominal sacral hysteropexy will be perform with polypropylene~     mesh. After 1 mont operation vaginal configuration will be evaluate with MRI on three plane~     (axial, sagittal, coronal). Then the results of thus two groups will be compare to results of~     nullipara patients. Investigators will investigate which technique keep the vaginal axis is~     closer to the original anatomic position.~   "
68755|NCT02666989|"~     Open label placebo treatment has been tried for irritable bowel syndrome (Kaptchuk et al,~     2010), where three weeks of open label placebo proved superior to a wait-listed control~     group. Another pilot study demonstrated efficacy in treating children suffering from ADHD~     with open label placebo treatment (Sandler & Bodfish, 2007). Recent work has shown that~     placebo openly given can have significant analgesic effects for acute migraines (Kam-Hansen~     et al, 2014) and for experimentally-induced pain (Schafer at al, 2015). A preliminary attempt~     to treat depression with open label placebo proved the feasibility of such a study, but was~     too small and brief for conclusive results (Kelley et al, 2012).~      We provide here the protocol for a study to assess the effect of open label placebo treatment~     for depression.~   "
68756|NCT02666976|"~     Non-erosive reflux disease (NERD) patients used to be less responsive to proton pump~     inhibitor (PPI)s as compared with patients with erosive esophagitis. The aim of this study is~     to objectively evaluate the effect of a new PPI, ilaprazole in NERD for adjusting the focus~     of symptom score, histopathologic findings and inflammatory biomarker.~      A prospective study performed at single hospital enrolled 20 patients who were diagnosed~     clinically as NERD. Patients underwent EGD, a 24hr-combined multichannel intraluminal~     impedance and pH esophageal monitoring (MII-pH) and were treated with ilaprazole 20mg once~     daily for 4 weeks. Biopsies were obtained from 3cm above the EG junction before and after~     treatment. GERD Q questionnaire, histologic findings (basal cell hyperplasia, papillary~     elongation, dilated intercellular spaces, intraepithelial eosinophils and intraepithelial T~     lymphocyte) and inflammatory biomarkers (TNF-α, IL-8, IL-1β, TRPV1 and MCP-1) will be~     accessed.~   "
68757|NCT02666963|"~     This study will assess the safety, tolerability, and pharmacokinetic profile of RTA 901~     following escalating single and multiple oral doses of RTA 901 in healthy adult subjects.~      This first-in-human, Phase 1, single-center study consists of single ascending doses (SAD)~     and multiple ascending doses (MAD) conducted in 2 parts. Part 1 (SAD) of this study will be~     conducted in approximately 56 healthy subjects in up to 7 groups. Each group will consist of~     up to 8 subjects who will be randomized in a 3:1 ratio to receive a single dose of RTA 901 or~     placebo, respectively. Safety, tolerability, and available pharmacokinetics through Day 4~     will be assessed in each group prior to dose escalation.~      Part 2 (MAD) of this study will be conducted in approximately 30 healthy subjects in up to 3~     groups. Each group will consist of up to 10 subjects who will be randomized in a 4:1 ratio to~     receive 14 daily doses of RTA 901 or placebo, respectively. Safety, tolerability, and~     available pharmacokinetics through Day 17 will be assessed in each dosing group prior to dose~     escalation.~   "
68758|NCT02666950|"~     This randomized phase II trial studies how well WEE1 inhibitor AZD1775 with or without~     cytarabine works in treating patients with acute myeloid leukemia or myelodysplastic syndrome~     that has spread to other places in the body and usually cannot be cured or controlled with~     treatment. WEE1 inhibitor AZD1775 may stop the growth of cancer cells by blocking some of the~     enzymes needed for cell growth. Drugs used in chemotherapy, such as cytarabine, work in~     different ways to stop the growth of cancer cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. It is not yet known whether giving~     WEE1 inhibitor AZD1775 works better with or without cytarabine in treating patients with~     advanced acute myeloid leukemia or myelodysplastic syndrome.~   "
68759|NCT02666937|"~     A study consisting of a prospective and retrospective cohort in the ICU, ER and pulmonary~     department in a university hospital in Amsterdam and a teaching hospital in Alkmaar, the~     Netherlands.~      The relationship between the oxygen saturation measured by pulse-oximetry and the arterial~     PaO2 is investigated in order to investigate which transcutaneous saturation values are safe~     when administering oxygen in relation to hyperopia and hypoxia.~   "
68760|NCT02666924|"~     This study aims to determine whether providing language and culturally appropriate cooking~     classes to Chinese Canadian individuals with diabetes will help to improve their diabetes~     control, knowledge and self care activities. The control group will receive current standard~     care of two diabetes education classes led by the dietitian and nurse. The intervention group~     will receive standard care and a series of four interactive cooking classes led by a~     dietitian, nurse and chef. We will compare the results of blood work, knowledge and self care~     questionnaires between the two groups to determine whether there are any benefits to~     attending these cooking classes.~   "
68761|NCT02666911|"~     Investigators will recruit 20 healthy volunteers between the ages of 18 and 80, who have no~     history of carpal tunnel syndrome or wrist injury. Images will be captured twice, first with~     the 2D transducer and then with the 4D transducer and compared to images captured with the~     new 4D transducer, using the same movement data analysis protocols. Investigators will also~     assess the inter and intrarater reliability of the 4D transducer images, by using two~     different sonographers, both trained in the technique, measuring the same blinded images on~     separate occasions, at least two weeks apart. The overall goal of this project is to assess~     the reliability, or reproducibility, of measurements in normal subjects using a novel 4D~     ultrasonographic method to characterize the subsynovial connective tissue (SSCT) and detect~     motion between SSCT, median nerve and tendon motion for the evaluation and diagnosis of~     patients with disorders affecting the carpal tunnel, especially carpal tunnel syndrome (CTS).~   "
68764|NCT02666872|"~     Vaccination greatly reduced mortality and morbidity from many preventable diseases. However,~     to avoid the resurgence of these diseases and the human drama associated, high vaccine~     coverage should be maintained in the population. Yet in Quebec, vaccine coverage (VC) in~     young children remains suboptimal, especially caused by a proportion of parents who are~     ambivalent about the safety and effectiveness of vaccines. In this context, the Provincial~     Immunization Committee developed in 2010 a Quebec's immunization promotion plan.~      Therefore, our research team tested and validated across the Eastern Townships, a vaccination~     promotion concept by means of an educational intervention within maternities, based on~     motivational interviewing techniques. This intervention has not only significantly increased~     the intention of vaccination (+15%) within parents who had received the intervention but also~     increased their child vaccination coverage (+7.5% at 7 months). This is the purpose of the~     PROMOVAQ study (PROmotion of VAccination in Quebec) This research project evaluated the~     impact of an educational strategy based on motivational interviewing techniques within~     maternity ward on infants' VC. This strategy has been tested through a provincial study~     (Montreal, Quebec, Sherbrooke) including more than 2500 families.~      At term, this research program will offer the Quebec's Health Ministry an optimal strategy~     for immunization awareness so that Quebec's children may grow healthy and thrive.~   "
68765|NCT02666859|"~     The proposed project is to develop an effective prosthetic training and rehabilitation~     regimen, with the use of virtual reality, to return patients to the highest level of~     independence and functioning possible. The Computer Assisted Rehabilitation Environment~     (CAREN) system (Motek Medical, Netherlands) will be used to immerse patients into real life~     situations while providing real time visual feedback of their motion to improve the training~     and rehabilitation of upper limb prosthetic users.~   "
68766|NCT02666846|"~     This is a randomised, double blind, cross over clinical study in healthy human volunteers~     (including pharmacokinetic [PK] sampling and laser Doppler assessment of local blood flow in~     a subset of up to 6 subjects per cohort of 20) to assess the efficacy and safety of three~     different topical analgesics (DCF100, TIB200 and SPR300) versus placebo and active control(s)~     in a model of UV-induced inflammatory pain.~   "
68767|NCT02666833|"~     The purpose of the study is to evaluate the ability and efficacy of using a~     polarization-enhanced reflectance and fluorescence imaging device, PERFIS, (see the Device~     Brochure) for demarcation of nonmelanoma skin cancer margins prior to surgery. PERFIS is a~     harmless and non-invasive device that has been used to image biological tissue both in vitro~     and in vivo. In this study it will be used to image nonmelanoma skin cancer lesions prior to~     surgery. The use of PERFIS will not affect patient care or treatment decisions in any way. No~     extra tissue will be used for imaging.~   "
68768|NCT02666820|"~     Endoscopic sphincterotomy (EST) combined with large balloon dilation (LBD) has been~     increasingly accepted as alternative method for removal of large bile duct stones. However,~     there were limited studies comparing the efficacy of EST in combined with LBD to EST with~     mechanical lithotripsy (ML). The purpose of this study to compare the efficacy and safety of~     combined EST- LBD versus EST-ML in the removal of very large bile duct stones.~   "
68769|NCT02666807|"~     This study evaluates the effect of ginger on NF-KB level in Peripheral Blood Mononuclear~     Cells in type 2 diabetic patients. Half of patients will receive ginger, while the other half~     will receive placebo.~   "
68770|NCT02666794|"~     The combined spinal-epidural analgesia during the labor has been associated with changes in~     fetal heart rate, which the opinions in literature are not fully consolidated and some~     studies have failed to show an increase significant fetal bradycardia following the~     combination lock. In addition, it's not clear that these changes found may modify the~     perinatal outcome in pregnancies who attend with intrauterine growth restriction (IUGR),~     since there are no studies comparing the techniques in this population.~   "
68771|NCT02666781|"~     Patients with obstructive sleep apnea (OSA) are more likely to experience postoperative~     complications and impact significantly on healthcare resources. In the surgical population,~     the type and volume of IV fluid administration may contribute to the worsening of~     postoperative sleep apnea but the pathophysiological mechanisms have not been elucidated.~     Recent research from general population suggests that intravenous (IV) fluid administration~     worsens the severity of OSA by shifting of fluid from the legs to the neck thus increasing~     neck size and causing airway collapse. In this novel study, our objective is to examine the~     contribution of IV fluid administration and rostral fluid shift from the legs to the neck~     thereby leading to worsening of sleep apnea following surgery. In this prospective~     observational cohort study, 25 consecutive adult patients, requiring at least 2 days hospital~     stay, will be recruited. Following informed consent, patients will undergo portable home~     sleep study to determine the preoperative severity of sleep-disordered breathing. On the day~     of surgery, leg, neck and total body fluid volumes will be recorded, and patients will~     undergo general anesthetic. The results of this study will be used to design future clinical~     trials evaluating methods to decrease postoperative OSA worsening, as well as decreasing~     OSA-related postoperative complications.~   "
68772|NCT02666768|"~     This study evaluates the effects of ACTIMMUNE (IFN-γ1b) in children and adults with~     intermediate osteoporosis. All participants will receive treatment with ACTIMMUNE for 12~     months. The investigators hypothesize that ACTIMMUNE will be tolerated by participants for~     the full 12 months and result in decreased disease severity.~   "
68773|NCT02666755|"~     The purpose of this study is to investigate the sensitivity，specificity and concordance rate~     of EGFR testing results in plasma in comparison of results in matched tumor tissues tested by~     amplification refractory mutation system(ARMS). Moreover, the investigators correlate our~     findings in plasma with survival of advanced patients.~   "
68774|NCT02666742|"~     The purpose of this study is to learn if taking a drug called Apixaban after an ablation~     procedure keeps blood clots from forming and lowers the chance of having a stroke in patients~     with ventricular tachycardia (VT).~   "
68775|NCT02666729|"~     The purpose of this study is to collect information about the success rate of atrial~     fibrillation (AF) ablation procedures using the contact force data from the TactiCath Quartz~     ablation catheter.~   "
68835|NCT02665936|"~     The purpose of this study is to detect whether the addition of epidural dexamethasone will~     prolong labor analgesia.~   "
68776|NCT02666716|"~     The pharmacokinetics of fluconazole are expected to be different in ICU patients compared to~     non-ICU patients. The investigators will determine fluconazole and free fluconazole~     concentrations in 20 ICU patients, who will get intravenous fluconazole as standard care.~     Switching to oral/enteral fluconazol is allowed after day 3.~      A full pharmacokinetic curve will be taken on day 3 of iv therapy and limited pharmacokinetic~     curves on day 7 of iv therapy and/or on day 3 of oral therapy; trough levels will be taken~     daily after intravenous therapy.~   "
68777|NCT02666703|"~     The modern era of cardiac surgery began in early 1950s with the introduction of~     cardiopulmonary bypass (CPB). Although it has been clearly shown that CPB is almost~     unavoidable for most open heart operations, an undesirable systemic inflammatory response~     syndrome (SIRS) is associated with its use. This complex chain of events has strong~     similarities with sepsis and may contribute to the development of postoperative complications~     and multiple organ failure (MOF). It has been shown that an excessive compensatory~     anti-inflammatory response (CARS) after SIRS can lead to immune paralysis and increased rate~     of hospital acquired infection. The balance of pro-inflammatory and anti-inflammatory~     mediators determines the inflammatory response and the clinical outcome. Accordingly, great~     efforts have been focused on therapeutic interventions aimed at reducing the inflammatory~     reactions during CPB, including pharmacologic strategies and modification of surgical~     techniques or mechanical devices. Such therapies may provide improvements in patient outcome~     after open heart operations. Among pharmacologic strategies is the prophylaxis with~     corticosteroids, which have been used during open heart surgery for more than 30 years. Many~     studies, both experimental and clinical, failed to produce evidence in favor of steroid~     treatment. As far as medical devices are concerned, the use of extracorporeal cytokine filter~     CytoSorb looks promising in cardiac surgery. It was recently approved by European Medicines~     Agency as an active treatment to fight cytokine storm.~      Serum paraoxonase 1 (PON1) is a lipo-lactonase, being associated with HDL that has an~     anti-inflammatory role and protects against atherosclerosis. Low levels of PON1 are~     associated with venous graft occlusion in patients with coronary artery bypass grafting. PON1~     reduces monocyte chemotaxis and adhesion to endothelial cells, leading to inhibition of the~     differentiation of monocytes into macrophages. The effects of cytokine adsorption therapy on~     PON1 are unknown.~      The aim of the study is to explore the effects of extracorporeal immunoadsorption during CPB~     on pro-inflammatory and anti-inflammatory protective mediators and cellular immune status in~     cardiac surgery.~   "
68778|NCT02666690|"~     RECIST criteria for evaluating tumor response are often inadequate for the evaluation of~     anti-angiogenic drugs. An evaluation model of tumor perfusion with contrast-enhanced~     ultrasonography was developed at Gustave Roussy. It assesses the tumor vascular response~     through the analysis of 7 different parameters. Several studies (four at IGR, involving 117~     patients, and a multicenter study involving 400 patients) showed that CEUS allows early~     evaluation of the effect of anti-angiogenic drugs. Two of these parameters are particularly~     interesting for the early identification of patients responding (or not) to treatment. Those~     are area under curve , and area under the wash-out. To further validate the use of these~     parameters, it is essential to measure and describe the level of their intra-patient~     variability.~   "
68779|NCT02666677|"~     This study is an online survey asking for invasive instrumention in trauma patients of an~     emergency department~   "
68780|NCT02666664|"~     The purpose of this study is to see if ETC-1002 (bempedoic acid) is safe and well-tolerated~     versus placebo in patients with high cardiovascular risk and elevated LDL cholesterol that is~     not adequately controlled by their current therapy.~   "
68781|NCT02666651|"~     Low blood sodium is a common observation in patients presenting with heart failure and is~     associated with increased mortality, prolonged hospital stay, and repeat hospital visits.~     Tolvaptan is a new and approved medication to treat low sodium levels in patients who present~     with symptoms of heart failure, however, it is not currently available as a treatment option~     due to high costs not covered by our provincial plan. In this observational, non-randomized~     study the drug will be provided to all subjects free of charge and given only during their~     hospital stay. After discharge subjects will be followed for 6 months (3 visits).~   "
68782|NCT02666638|"~     The objective of this study is to determine whether these new image acquisition strategies~     and techniques using of up to 7T can produce meaningful structural and physiological~     information that can serve to improve our understanding of various disease processes in the~     clinical setting. 200 Control volunteers will be scanned for approximately one hour, without~     contrast, on up to 7T MRI scanner. 200 Study Participants will be scanned using newly~     developed imaging software or hardware that conforms to applicable FDA standards and~     recommendations. The data (images) for the Control and Experimental Group will be~     de-identified by the scan technologist and downloaded to a workstation within the Radiology~     Department for offline processing. These images will be reviewed by a trained Radiologist~     after the subject has departed.~   "
68783|NCT02666625|"~     The constitution of a biological samples bank, attached to epidemiological studies Cohort~     F-CCSS on iatrogenic effects of treatment of childhood cancer, will identify genetic variants~     that can modulate the iatrogenic risks of these treatments. The main objective is to provide~     a biological samples bank to consider, besides the carcinogenic risks, the risk of other~     iatrogenic diseases in these children, in particular cardiac, cerebrovascular, lung, bone and~     kidney. These conditions can be very incapacitating and in some cases, fatal. Their impact,~     however, is poorly estimated as occurring in adulthood, they are rarely made in relation to~     the treatment received in childhood. The overall project is expected to eventually better~     define the iatrogenic effects prevention strategies for cancer treatment.~   "
68784|NCT02666612|"~     Monitoring of circulating endothelial cells (CEC and mature cells called progenitors called~     CEP) or circulating tumor cells (CTC) in adult patients with metastatic cancer, possibly~     treated with targeted therapy.~   "
68785|NCT02666599|"~     The objective of the study is to evaluate the sensibility of the probe Forimtech to detect β+~     emission in vivo in humans and its usefulness during elective surgical procedure~     Hypothesis:The probe Forimtech is able to allow per-surgery detection of tumoral lesions~     sensible to 18F-FDG and to help in the realization of guided biopsies, minimally invasive~     surgery or complement of resection of tumors.~      The β+ emission detected by the probe Forimtech is correlated to the emission γ detected by~     the 18F-FDG.PET/CT~   "
68786|NCT02666586|"~     To describe the effect and mechanisms of action faba bean powder and fractions (protein,~     starch and fiber) on glucose and insulin homeostasis, food intake, satiety and metabolic~     regulation in young adults (18 to 30 years).~   "
68836|NCT02665923|"~     Ultrasound imaging will be used to (1) evaluate gastric antral volumes in children presenting~     for anesthesia who have been fasted, and (2) to evaluate time for gastric emptying in~     healthy, fasting newborns, and infants following feeding of clear liquids and/or milk~     (including breast or formula).~   "
68787|NCT02666573|"~     27 subjects on SPT, each with at least two residual pockets ≥5mm, were recruited for this~     randomised, split-mouth controlled trial, providing a total of 72 sites. At baseline, probing~     pocket depth (PPD), recession, clinical attachment level (CAL), plaque and bleeding on~     probing (BOP) of all sites were examined. Gingival crevicular fluid (GCF) were collected to~     determine level of cytokines IL-1β, -6, -8, TNF-α and MMP-8 via ELISA. Control sites received~     subgingival instrumentation and rubber cup polishing with pumice. In addition test sites~     received a single application of PDT using Fotosan® and photosensitizer consisting of~     toludine blue O solution. The subjects were recalled three and six months later and~     re-examined. Site level analysis was performed.~   "
68788|NCT02666560|"~     To determine the clinical efficacy of auditory cueing using a cross over design to~     investigate whether increasing auditory cueing frequency by 20% above self paced cadence~     affects gait parameters in children with Cerebral Palsy when performing a functional task.~   "
68789|NCT02666547|"~     This study will assess the potential of the 68Ga-NODAGA-RGD for the evaluation of~     neoangiogenesis in patients followed for a neoplastic pathology and for whom a18F-FDG (or~     18F-FET for gliomas) is indicated for initial extension evaluation or suspicion of recurrent~     tumor.~   "
68790|NCT02666534|"~     Surgical excision is the standard treatment for cutaneous SCC. However, many patients~     diagnosed with SCC are elderly and ineligible for surgery. Ablative fractional laser-~     assisted photodynamic therapy (AFL-PDT) offered a higher efficacy than conventional~     Methylaminolevulinate (MAL)-PDT.~   "
68791|NCT02666521|"~     Despite type 2 diabetes comprising the majority of cases of diabetes, the overall frequency~     of hypoglycaemia in this group has not been as carefully documented as in type 1 diabetes,~     particularly in relation to the clinical use of individual therapies in primary care.~      The aim of this study is to provide robust data on the frequency and severity of~     hypoglycaemia in people with type 2 diabetes managed in primary care, and assess and explore~     associated risk factors.~   "
68792|NCT02666508|"~     Dental plaque causes caries and periodontal disease and data are sparse about toothpaste and~     plaque removal. Inflammation, caused by dental plaque, is a risk factor for cardiovascular~     disease. (CVD) The availability of (Plaque HD (TM), a plaque identifying toothpaste with~     targetol technology (TM)), afforded the unique opportunity to test whether there were~     statistically significant and clinically important reductions in plaque and inflammation in a~     randomized trial of apparently healthy individuals.~   "
68793|NCT02666495|"~     A reliably effective treatment model for anorexia nervosa is yet to emerge. Recent clinical~     trials of psychological therapies over 20-30 sessions, have shown modest benefits. There is~     therefore a need to test new treatments to find more effective treatments. Clinical trials of~     Schema Therapy have shown low rates of dropout, which is often a problem in the treatment of~     anorexia nervosa. Treatment with Schema Therapy, for significantly longer than 20-30~     sessions, has been shown to be effective for other complex mental health problems.This pilot~     study is therefore designed to pilot the use of individual Schema Therapy for people with~     Anorexia Nervosa (iST-AN). This study is a case series pilot study. The study will answer the~     principal research question: Does individual Schema mode Therapy, adapted for eating~     disorders, have the potential to improve symptoms, quality of life and weight in people with~     moderate-severe anorexia nervosa? It will also address secondary research questions: Can~     people with moderate-severe anorexia nervosa be recruited to, and kept engaged in, a study of~     iST-AN treatment? What is the ideal length of iST-AN treatment? What is the relationship~     between self-criticism, body shame, or unhelpful psychological 'modes' and clinical outcome?~     Fifteen people with moderate-severe Anorexia Nervosa will be recruited from referrals to a~     specialist eating disorders outpatient service. The study will deliver 65 sessions of Schema~     Therapy for anorexia nervosa (iST-AN), over a 24 month period, alongside any additional~     medical or dietetic management required. Standard outcome measures will be collected at 6~     month intervals. The research team have expertise in eating disorders research, schema~     therapy for severe anorexia nervosa and are all members of the local clinical service. The~     study will take place over a 3 year period.~   "
68794|NCT02666482|"~     The Institute for International Internet Interventions for Health (i4Health) at Palo Alto~     University proposes to develop digital tools specifically designed to help low income~     English-speaking and Spanish-speaking smokers to quit. The investigators aim to test whether~     a mobile-based digital intervention designed with systematic input from low-income English-~     and Spanish-speaking smokers from a public sector health care system can significantly~     improve its acceptability, utilization, and effectiveness. Using human-centered development~     methods, the project will involve low-income patients of the San Francisco Health Network in~     the design of a web app/text messaging tool. The investigators will also use participants~     input to improve the recruitment and dissemination strategies. i4Health will join forces with~     the Center for Behavioral Intervention Technologies (CBITs) at Northwestern University to~     iteratively develop successive versions of the digital interventions informed by our~     human-centered approach.~      The full study involves 4 successive outcome studies testing the effectiveness of the Stop~     Smoking San Francisco web app.~      The first three are single-group non-randomized pre-post studies with 1, 2, and 3-month~     follow-ups. These will test gradually improved versions of the app.~      The fourth study will involve a randomized trial comparing the initial version (the baseline~     version) of the web app to the final version of the web app, to determine if the final~     version is significantly better than the baseline version in terms of increased utilization~     and abstinence rates.~      To join this study, go to: https://stopsmokingsf.org~   "
68795|NCT02666469|"~     Stroke is one of the leading causes of disability and death in North America and Europe. Up~     to 30% of stroke survivors never recuperate completely and suffer from loss of function and~     poor quality of life. To improve recovery after stroke, innovative interventions should be a~     priority.~      Hyperbaric oxygen therapy (HBOT) is an intermittent inhalation of 100% oxygen in a hyperbaric~     chamber at a pressure higher than 1 absolute atmosphere (ATA). There is a growing body of~     evidence that HBOT can enhance ability of brain to changes its structure (neuroplasticity) in~     order to recover. Exercise program during HBOT can augment the effect. Although, recent~     randomized controlled trials in patients with chronic brain injury showed promising results,~     there are no studies demonstrating combine effect HBOT and exercise rehabilitation program on~     stroke recovery.~      The proposed study investigates feasibility, safety and efficacy of using a combination of~     HBOT and exercise program to improve arm function recovery in chronic stroke patients. In~     this pilot randomized control trial, investigators will compare the combination of HBOT and~     the focused rehabilitation exercise program versus exercise program alone on recovery of arm~     function in patients with chronic stroke.~   "
68796|NCT02666456|"~     Cross-sectional and longitudinal analysis of the somatosensory phenotype, assessed by~     quantitative sensory testing (QST) and Information obtained by questionnaires to detect risk~     factors for neuropathic pain development and chronification in painless and chronic pain~     patients.~   "
68797|NCT02666443|"~     Brachial plexus nerve blocks provide superior analgesia over opioids while avoiding unwanted~     side effects. Single shot blocks with local anesthetic alone usually do not last the duration~     of the acute post-surgical pain period. This has led to the exploration of multiple adjuvants~     to increase the duration of single shot blocks, the most promising adjuvant being~     dexamethasone.~      Peri-neural administration is an off-label use of dexamethasone. While no adverse events have~     been reported in human clinical studies, logic would dictate that we minimize the dose needed~     to produce the desired effect. Most studies thus far have used peri-neural dexamethasone~     doses ranging from 4-10 mg. However, Albrecht et al. found no difference in block duration~     comparing 4 mg and 8 mg doses while Liu et al. reported equivalent block duration using doses~     of 1, 2 and 4 mg.~      Recent studies have evaluated whether systemic and peri-neural administrations of~     dexamethasone are equivalent, which would in turn imply a site of action. Results have been~     mixed. Four studies concluded peri-neural and intravenous administration are equivalent at~     prolonging analgesia, though one study had methodological errors, including the~     administration of intravenous dexamethasone to all patients. All of these studies used~     dexamethasone doses of 8 to 10 mg. One study where a lower dose (4 mg) was used found that~     peri-neural administration prolonged block duration whereas intravenous did not.~      With that, the rationale of our study is to determine if equivalent block-prolonging~     analgesia can be achieved using low dose (1 mg) dexamethasone given peri-neural or~     intravenous. Clinical experience at our centre has been that 1 mg dexamethasone added to 20~     mL produces similar block duration to that reported in published studies using higher doses.~   "
68798|NCT02666430|"~     The aim of this extension study is to assess the safety and efficacy of Mylan's insulin~     glargine and Lantus® in T1DM patients.~   "
68799|NCT02666417|"~     Infants and young children in sub-Saharan Africa have high rates of iron deficiency anemia~     (IDA), which adversely affects their growth and cognitive development. In-home iron~     fortification of complementary foods using micronutrient powders (MNPs) reduces risk for IDA.~     However, in areas with a high burden of infectious diseases iron may increase the risk of~     unfavorable gut microbiota composition possibly influencing diarrhea prevalence. Thus, there~     is an urgent need to find safer formulations of iron fortification for African infants. The~     investigators recently finished a randomized, double blind controlled intervention trial in~     Kenya where the investigators tested whether the addition of galacto-oligosaccharides (GOS)~     in a MNP containing 5 mg of iron protects against the adverse effects of the iron on the~     infant gut microbiome and gut inflammation (ClincalTrails.gov Identifier: NCT02118402).~     Prebiotics are also potential enhancers of colonic iron absorption. Therefore, to complement~     the intervention study, the present study will compare iron absorption from the combination~     of sodium iron EDTA (NaFeEDTA) and ferrous fumarate (FeFum) with and without prior~     consumption GOS or 3 weeks. The investigators will enroll 80 Kenyan infants from Kwale~     County, aged 6-14 months of whom 40 infants will consume maize porridge blended with MNP~     containing iron and 40 infants will receive a porridge mixed with MNP containing iron+GOS.~     After 3 weeks of MNP consumption, two test meals will be fed on two consecutive mornings, and~     will consist of maize porridge containing isotopically labeled FeFum and NaFeEDTA or~     isotopically labeled ferrous sulfate (FeSO₄), respectively. Fourteen days after the second~     test meal administration, a whole blood sample will be collected by venipuncture for iron~     isotopic analysis. Iron and inflammation status parameter will be determined at baseline and~     endpoint. A stool sample will be collected at baseline and on the first test meal day. The~     gut microbiome, fecal pH and fecal SCFAs profile will be analyzed. Knowing the expected iron~     absorption from the iron and GOS containing MNP will inform decisions on type of iron~     compound and dosing regimens for MNPs to allow the lowest iron dose to be used but still~     cover the infant requirement for absorbed iron.~   "
68800|NCT02666404|"~     Volume resuscitation is the mainstay of treatment in most types of shock, especially in~     hemorrhagic and septic shock. Septic shock is a main cause of morbidity and mortality~     worldwide. Although there has been a lot of research to evaluate optimal amount and~     composition of fluids for volume resuscitation (e.g. colloids, crystalloids, red blood cell~     transfusion, albumin, fresh frozen plasma) particularly in the past decade, results remain~     inconclusive and to some extent contradictive. The investigators would like to contribute to~     the establishment of new endpoints for the guidance of shock therapy focusing on the first 24~     and 48 hours, amending the currently used parameters (i.e. cardiac output, heart rate, blood~     pressure, central venous pressure) with new measurements (see study specific measurements).~     The goal is to decrease the need for renal replacement therapy, thereby eventually reducing~     patient morbidity and mortality.~   "
68801|NCT02666391|"~     The purpose of the present study is to evaluate the safety and exploratory efficacy of the~     umbilical cord mesenchymal stem cells for patients with ischemic heart diseases.~   "
68802|NCT02666378|"~     This research study is evaluating the use of Cardiac Magnetic Resonance Imaging (CMR) as a~     method of detecting early signs of damage to the heart that can be associated with adjuvant~     therapy of anthracycline (doxorubicin)-based combination chemotherapy followed by treatment~     with herceptin (trastuzumab for the treatment of (HER+) breast cancer.~   "
68803|NCT02666365|"~     Patients undergoing an elective ventral hernia repair will be randomly assigned to receive~     either bolus infusion or continuous infusion of the cefazolin as the prophylactic antibiotic.~     The blood concentrations of unbound cefazolin would be measured in their blood samples and~     the levels compared within the two groups with respect to their minimal inhibitory~     concentration (MIC) value.~   "
68804|NCT02666352|"~     This is a 2-part, non-randomized, open-label, single-dose study to evaluate the~     pharmacokinetics (PK) of uprifosbuvir (MK-3682), its metabolites M5 and M6, and ruzasvir~     (MK-8408) in participants with moderate hepatic insufficiency (HI) (Part 1) and in~     participants with severe HI (Part 2) compared to those in matched healthy particpants.~   "
68805|NCT02666339|"~     Each hospitalization leads to stress and anxiety. This is particularly true in psychiatry,~     because of decompensation. That is why therapeutic treatments are delivered quickly to~     treat these symptoms and to allow a better relationship with patients. This relationship~     patients-nursing staff called therapeutic alliance is needed in psychiatry. Moreover, other~     treatments added to the therapeutic ones are used, like mediation, to increase the patients'~     state of health.~      These last years, numerous studies were based on hortitherapy or care-gardens. It consists in~     the use of plants with a medical staff (for example nurses). A lot demonstrated the efficacy~     of the care-gardens, but most of them showed methodological weaknesses.~      That is why the investigators would like to perform a randomized study, controlled, and they~     aim to demonstrate the efficacy of hortitherapy on anxiety in patients allowed in adult~     psychiatry for at least 4 weeks.~   "
68837|NCT02665910|"~     Condition: Rheumatoid Arthritis Intervention: Drug: SHR0302; Drug: SHR0302 placebo comparator~     Phase: Phase 1 Study Type: Interventional Study Design: Treatment, Parallel Assignment,~     Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Randomized~   "
68806|NCT02666326|"~     Every year > 50.000 people in Denmark are hospitalized with a suspected acute myocardial~     infarction (AMI). The majority has other explanations of their chest discomfort and most are~     discharged again without any initiation of treatment. Still, the suspicion dictates acute~     ambulance deployment, hospital admission to a highly specialized cardiac unit, cardiac~     surveillance and cardiac troponin blood sampling. The novel biomarker copeptin, a byproduct~     of vasopressin production, is released immediately from the pituitary gland as part of the~     hormonal response to AMI. Peak concentrations are reached within the first hour. Previous~     studies have suggested the combination of copeptin and cardiac troponin for fast and reliable~     rule out of AMI. However, the blood sampling should be performed as soon as possible after~     symptom onset, preferably already during the prehospital phase.~      We aim, in an open randomized setting, to investigate the combined measurement of prehospital~     copeptin and in-hospital high sensitive cardiac Troponin T compared to the standard rule-out~     procedure of suspected myocardial infarction. We hypothesize that the combined measurement of~     prehospital copeptin and in-hospital high sensitive troponin T:~        1. Reduces admission time by 1.5 hours in patients where AMI is ruled out~        2. Reduces the time to disposition~        3. Is non-inferior compared to the standard rule-out procedure in relation to major adverse~          cardiovascular events.~        4. Is more cost efficient compared to standard diagnostic strategy~   "
68807|NCT02666313|"~     Regular exercise is a core component of the long-term management of people with axial~     spondyloarthritis (axial SpA). However, delivering long-term exercise programmes is~     unrealistic and unsustainable using traditional NHS services. Web-based physiotherapy, has~     been developed, a possible alternative service model to support people with axial SpA to~     exercise regularly however long-term compliance to the programme (12 months) needs to be~     established. The aim of this prospective cohort study is to assess the feasibility,~     sustainability and acceptability of a 12 month individualised web-based physiotherapy~     programme in people with axial SpA. Fifty people with established axial SpA, will receive 12~     months of individualised, remotely monitored, web-based physiotherapy. The primary outcome~     will be four weekly compliance rates with the programme over the 12 month period. Secondary~     outcomes (baseline, 6 and 12 months) will include function, disease activity, spinal~     mobility, quality of life, attitudes and motivations towards exercise, fitness, health~     status, employment, physical activity. The number of interactions with health care~     professionals and changes in medication will be documented. A subsample of the cohort will be~     interviewed at 6 and 12 months to gather participants' views of the web-based physiotherapy~     programme and factors influencing compliance with the programme.~   "
68808|NCT02666300|"~     Postoperative Sore Throat (POST) is supposed to be the most frequently occurred respiratory~     complication related to endotracheal intubation .Whether the new type of ETT(TaperGuard ETT)~     to decrease or to increase the complications of general anesthesia compared with~     Cylindrical-shaped ETT is still unknown .In this study ,we will compare the different~     incidence of complications following general anesthesia between TaperGuard ETT and~     Cylindrical-shaped ETT under high endotracheal tube cuff pressure.~   "
68809|NCT02666287|"~     Batefenterol (BAT) is a novel bifunctional molecule that combines muscarinic antagonism and~     beta2-agonism in a single molecule and is in development for the treatment of chronic~     obstructive pulmonary disease (COPD). FF is a corticosteroid approved as the inhaled~     corticosteroid (ICS) component of a combination product, with vilanterol (VI), a long-acting~     beta2-agonist for COPD. In the current study FF will be investigated as an inhaled product in~     combination with BAT, for treatment of COPD.~      This study is an open-label, six-way crossover, single and repeat dose study to evaluate the~     systemic pharmacokinetics, safety and tolerability of FF and BAT when administered via the~     ELLIPTA™ alone, in combination, or concurrently at 3 times the clinical dose, following a~     single dose, and at the proposed clinical dose, following repeat doses.~      This study will consist of screening period, 6 treatment periods, and a follow-up visit. Each~     subject will have 3 periods in which they receive a single dose treatment regimen (3~     inhalations on Day 1 of each single dose study period) and 3 periods in which they receive a~     single dose treatment regimen followed by a 7-day, once-daily, repeated dose. On Day 1 of~     those periods, subjects will receive their single dose as 3 inhalations. On Days 2-8,~     subjects will receive 1 inhalation per day for the repeated dose regimen. There will be a~     minimum of 7-day washout between each treatment periods. All subjects will receive 9~     treatments and follow-up procedures will be done 7 14 days after the last dose.~      Forty eight healthy subjects will be enrolled into the study, such that approximately 40~     subjects complete dosing and PK assessments. The total duration of participation for each~     subject in this study will be up to 15 weeks. ELLIPTA is a registered trademark of the~     GlaxoSmithKline [GSK] group of companies.~   "
68810|NCT02666274|"~     There are many bacteria that naturally live in our gut and are essential for good health.~     These bacteria have a variety of helpful functions, such as aiding digestion, synthesizing~     vitamins, repressing the growth of harmful bacteria and defending against some diseases. The~     desirable bacteria that live in the gut are collectively known as 'gut flora', or more~     appropriately, as 'gut microbiota'.~      The less desirable resistant bacteria, however, can also be carried in a person's gut for~     prolonged periods of time and be found in the stools without causing illness. Persons that~     carry the resistant bacteria in the gut are known as carriers and they require no~     treatment. Knowing that a person carries resistant bacteria is helpful, because it will~     inform the choice of antibiotic if the person were to become unwell or had an intervention~     such as surgery in the future.~      There is some evidence that resistant bacteria found in the stools can sometimes be passed~     from one person to another and eventually make someone ill if they infect (invade) their~     body. The investigators do not know how often this may happen, or how much carrying resistant~     bacteria in the stools may facilitate the spread of resistant bacteria in the population. It~     is important to address these questions and study ways to stop the resistant bacteria from~     spreading to safeguard the efficacy of antibiotics.~   "
68811|NCT02666261|"~     This non-interventional study will collect data from routine diagnostics on HER2 testing of~     breast cancer in Germany.~   "
68812|NCT02666248|"~     This is a non-therapeutic, long-term follow-up (LTFU) study of subjects who have received~     retroviral-based gene therapy products in cancer studies. All subjects in this LTFU protocol~     have received lentiviral modified T cells engineered to express an anti-EGFRvIII scFv~     Chimeric Antigen Receptor (CAR).~   "
68838|NCT02665897|"~     In view of both endothelial injury in pre-eclampsia, high blood pressure and kidney~     impairment characteristics, a recent study demonstrated that the serum levels of NGAL~     increased at the end of the second trimester in women who subsequently developed~     pre-eclampsia compared to the control group.~      This correlates well with the endothelial damage that occurs during pre-eclampsia and thus~     NGAL can be considered as a promising marker in predicting both early and late onset~     pre-eclampsia. It may be required to combine one or more biomarker with NGAL to increase the~     precision, and sensitivity for detection of risk and reliability of using biomarkers for~     pre-eclampsia.~   "
68813|NCT02666235|"~     Intermittent arm cuff inflation reduces the extent of heart muscle injury at the time of~     cardiovascular injury. The intervention is known as remote ischaemic conditioning (RIC)~     however the mechanisms by which RIC acts are incompletely understood.~      One mechanism that might explain the benefits of RIC is an improvement in coronary artery~     function which in turn might help improve blood flow to heart muscle.~      The investigators will perform a randomised controlled study of RIC in a minimum of 60~     patients with known or suspected angina and in whom coronary angiography with angioplasty~     would be considered.~      Following informed consent before the invasive procedure, the patient will be randomly~     assigned to the intervention group (cuff inflation protocol) or the control group (cuff~     placement, no inflation; sham protocol). Following initial coronary angiography, endothelial~     function will be assessed by intra-coronary infusion of acetylcholine in incremental doses.~     Coronary diameter will be measured after the procedure using quantitative coronary~     angiography, by a trained observer blinded to the allocated group. Since a neuro-hormonal~     response may potentially mediate RIC, a blood test will be performed before and after cuff~     placement in all patients (active and control groups) to measure circulating molecules known~     to regulate blood vessel function which may be implicated in a RIC-mediated effect on~     coronary artery tone.~      This study may provide clinically relevant insights into the mechanisms of action of RIC in~     patients with coronary heart disease.~   "
68814|NCT02666222|"~     The purpose of this study is to evaluate the long-term safety and efficacy of the Esteem®~     Hearing Implant in subjects suffering from moderate to severe hearing loss.~   "
68815|NCT02666209|"~     Participant that has been diagnosed with Relapsed/ Refractory Multiple Myeloma and are~     currently participating in a clinical trial which is closing. This research study is studying~     Ulocuplumab as a possible treatment. It's an expanded access from NCT01359657~   "
68816|NCT02666196|"~     This is a placebo-controlled randomized phase 1 study to investigate the safety and~     pharmacokinetics of DAA-I in a cohort of healthy subjects.~   "
68817|NCT02666183|"~     This study seeks to test the effectiveness of two arms of an intervention that use~     videoconference technology for distance caregivers of patients with advanced cancer. The~     study is significant because the intervention will promote involvement of caregivers of~     patients with cancer and makes a compelling case for significance based on changing~     demographics and lifestyles.~   "
68818|NCT02666170|"~     The aim of our study is to investigate the effects of six months treatment with alpha-lipoic~     acid on clinical, endocrine and metabolic features in women affected by PCOS. Menstrual~     pattern, anthropometric parameters, hirsutism score, ultrasound ovarian featureas, an oral~     glucose tolerance test and hormonal assays are evaluated before and after therapy.~   "
68819|NCT02666157|"~     1. The recent development of novel oral anticoagulants (NOACs), including direct thrombin~          inhibitor (dabigatran) and factor Xa inhibitors (rivaroxaban, apixaban, and edoxaban),~          could potentially overcome many drawbacks of warfarin, and might provide a safer, and~          even more effective and convenient alternative approach to warfarin in non-valvular~          atrial fibrillation (NVAF), especially in Asians.~        2. According to the results of a meta-analysis comparing Asians and non-Asians, NOACs are~          preferentially indicated in Asians in terms of both efficacy and safety.~        3. There is no randomized controlled trial with sufficient power to directly compare the~          efficacy and safety among NOACs in NVAF, not to speak of Asians and Chinese.~        4. Indirect comparisons are only based on observation with a lot of limitations such as~          heterogeneous background characteristics, difference in study design, and diversity in~          time within therapeutic range in control group. The findings from indirect comparisons~          are not conclusive but only hypothesis-generating.~        5. This investigator-initiated prospective randomized open blinded end-point clinical trial~          will directly compare the efficacy and safety among 3 NOACs in patients with NVAF in~          Taiwan. We hypothesize that rivaroxaban or apixaban is non-inferior to dabigatran in~          terms of the efficacy.~   "
68820|NCT02666144|"~     This prospective, monocentric, non-invasive clinical study is designed to measure normal~     structural parameters of the optic nerve head, the peripapillary retinal nerve fiber layer,~     and the macula using the Heidelberg Spectralis OCT device. This study is conducted in normal,~     healthy volunteers and glaucoma patients. The main goal of the study is to provide an~     analysis of the comparability of these parameters between two different software versions and~     their respective method of scan centration on the optic disc center. The study will include~     at least 40 eyes of 40 subjects; 20 normal, healthy subjects and 20 glaucoma patients. All~     subjects will undergo Spectralis OCT imaging, biometric and ophthalmoscopic examination, and~     visual field testing in one single visit. Total study duration (first patient first visit to~     last patient last visit) is anticipated to be approximately 4 weeks.~   "
68821|NCT02666131|"~     The purpose of this study is to determine whether Granexin gel is safe and effective in the~     treatment of diabetic foot ulcers.~   "
68822|NCT02666118|"~     Nerve blocks, or pain medication injected next to the nerve while patients are asleep, are~     commonly used for pain management after shoulder surgery and are considered highly effective~     in decreasing post-operative pain. There are several different ways to give a nerve block.~     All are effective and safe. The purpose of this research is to determine if one of the~     available ways to give a nerve block is more effective than the others.~   "
68823|NCT02666105|"~     This is a phase II single institution therapeutic study of adding exemestane therapy in~     post-menopausal women with advanced non-small cell lung cancer (NSCLC) who are progressing~     while on treatment with an immune checkpoint antibody (pembrolizumab, atezolizumab, or~     nivolumab).~   "
68839|NCT02665884|"~     Diurnal fluctuations of intraocular pressure in EX-Press Valve Blebs in Glaucoma Patients~      Intraocular pressure (IOP) reduction is the mainstay of glaucoma management. (1) Open-angle~     glaucoma (OAG) is generally managed by decreasing the intraocular pressure (IOP) to a level~     that the physician believes will prevent further glaucomatous damage. However, in a~     significant proportion of patients, the visual fields continue to deteriorate in spite of~     office pressures within the range of normal values (8). It has been suggested that the~     progressive damage in some cases could be caused by peaks of IOP or diurnal IOP variability~     not detected by tonometry during office hours. It is possible that certain drugs or surgical~     interventions are more effective than others in dampening these fluctuations. The purpose of~     our study is to compare the diurnal IOP fluctuations in glaucoma patients treated with~     medications or Ex-press filtration surgery.~   "
68824|NCT02666092|"~     Anisakidae frequently infect fish species that are commonly eaten by humans. Some of them are~     recognized as zoonotic diseases agents, and have a high impact on human health.~      Infestation results from the ingestion of living larvae from contaminated fishes. It can be~     asymptomatic or symptomatic, resulting in acute gastric, acute intestinal or chronic forms.~     Allergic manifestations are frequently encountered in gastric forms, but allergic symptoms~     can also occur in isolation, after ingestion of Anisakidae antigens contained in raw or~     cooked fish, and may masquerade as fish allergy.~      In this study, we aim to characterize the relationship between Anisakidae and/or fish~     sensitization and the presence of allergic manifestations in patients recruited in the~     general population and presenting fish allergy resulting from ingestion, cutaneous or~     respiratory contact. We will also determine the respective role of Anisakidae or fish~     sensitization in patients with fish allergy. Then, we will determine the prevalence of~     previous Anisakidae infections among these patients and a matched control population. We will~     also compare the performances of serological tests (ImmunoCAP, immunoelectrophoresis and~     Western Blot) for the diagnosis of Anisakidae allergy or infection. Lastly, we will explore~     the relationship between domestic exposure to Anisakidae or fish antigens and the occurrence~     of associated pathologies (Anisakidae or fish allergy/sensitization; Anisakidae infection).~   "
68825|NCT02666079|"~     This study is a prospective, single arm, multi-centre study to evaluate the intra-operative~     use of the LightPath™ Imaging System for the assessment of tumour margin status compared to~     hospital standard of care histopathology in wide local excision (WLE) for breast cancer~      The intraoperative 18F-fluorodeoxyglucose (18F-FDG) LightPath™ Images will be used to inform~     the surgeons about detectable residual cancer, in an attempt to achieve better guided cancer~     surgery and complete tumour excision with clear WLE resection margins.~      Study sites will use the local criteria considered standard of care to guide decisions to act~     on positive margins.~      In the LightPathTM arm the resection margin status of the WLE specimen, cavity shavings (if~     any) and the metastatic status of axillary (sentinel) lymph nodes as measured with the~     LightPath™ Imaging System will be compared with histopathology results.~   "
68826|NCT02666066|"~     Radiomics, the extraction of large amounts of quantitative image features to convert medical~     images into minable data, is an in-development field that intends to provide accurate risk~     stratification of oncologic patients. Published prognostic scores only take clinical~     variables into account. The investigators hypothesize that a combination of CT/MRI features,~     molecular biology and clinical data can provide an accurate prediction of medical outcome.~     The long term objective is to build a Decision Support System based on the predictive models~     established in this study.~   "
68827|NCT02666053|"~     The purpose of this study is to estimate the effect of high fat meal and increased gastric pH~     on BMS-663068 bioavailability~   "
68828|NCT02666040|"~     With reference to inguinal hernia surgeries with prosthesis, the multicenter study aims to~     investigate the benefits in terms of incidence of pain and discomfort, improvement in the~     quality of life for the patient after the use of the newly introduced semi-absorbable~     prosthesis (ULTRAPRO® meshes) compared with the prosthesis of totally nonabsorbable material~     (conventional meshes in polypropylene Prolene®), and in terms of the costs for the~     hospital, the National Health System (NHS), and the society of associates for the use of the~     ULTRAPRO® in inguinal hernia surgeries.~   "
68829|NCT02666027|"~     This study is being performed to determine the effectiveness of Fluid Intravenous Alert~     (FIVA) in monitoring intravenous fluid delivered to patients under anesthesia in a dimmed~     ambient light in the operating room.~   "
68830|NCT02666014|"~     The laparoscopic technique is commonly employed for abdominal gynaecological surgery in~     women. Postoperative nausea and vomiting (PONV) may occur in 30% of women undergoing~     gynaecological surgery. In patients with multiple risk factors for nausea and vomiting, the~     incidence is up to 80%. PONV has a significant negative effect on patient satisfaction after~     anesthesia and is one of the most common causes for unexpected hospital admissions in~     day-surgery.~      Sugammadex and Neostigmine are both drugs that are used to reverse the effect of muscle~     relaxation producing drugs that are commonly used during surgery. Neostigmine has been the~     drug of common use for this purpose, but PONV is reported with its usage.~      With this research we intend to determine whether the trial drug Sugammadex would reduce the~     incidence of PONV in high-risk women after undergoing laparoscopic gynaecological surgery~     when compared to Neostigmine.~   "
68831|NCT02666001|"~     The study is being conducted to assess the effect of multiple doses of BMS-663068 on the~     exposure of methadone in subjects on a stable dose of methadone, and the exposure of~     buprenorphine and norbuprenorphine in subjects on a stable dose of buprenorphine and~     norbuprenorphine.~   "
68832|NCT02665988|"~     Transcranial direct current stimulation (tDCS) is an investigational device that has not been~     approved for the treatment of any medical condition by the FDA but is allowed to be used for~     research purposes. In clinical trials tDCS has been associated with pain relief by decreasing~     the intensity and duration of chronic pain. tDCS potentially works by stimulating the brain~     by delivering an extremely low-level electrical current to areas below the forehead - areas~     associated with chronic pain. It is anticipated that this current will increase brain~     activity or the likelihood of brain activity in these areas, affecting individual's ability~     to regulate pain.~      The purpose of this study is to compare eligible participants in the Pain Management Program~     at The Menninger Clinic receiving adjunctive real transcranial Direct Current Stimulation~     (tDCS) versus those receiving sham tDCS in the resolution of chronic pain. The primary~     objectives are: (1) improving pain tolerance and (2) improving subjective pain experience.~     Secondary objectives are: (1) improving subjective experience of sleep quality and (2)~     increasing physical activity.~   "
68833|NCT02665975|"~     The purpose of this study is to compare the effectiveness of a CBT-based internet~     intervention with face to face standard clinical care for adults with tinnitus in the United~     Kingdom.~   "
68834|NCT02665962|"~     80% of endometrial cancer patients are overweight or obese. Preclinical and clinical data~     have shown that caloric restriction (CR) protects against organ injury and decreases~     perioperative morbidity. This is a feasibility trial to evaluate the effect of a 6 week~     perioperative CR on surgical and patient-reported outcomes in 20 obese newly diagnosed~     endometrial cancer patients. The intervention will provide individualized CR program, meal~     replacement products and nutritional counselling sessions.~   "
68841|NCT02665858|"~     Longitudinal clinical observation of optic nerve head, using slit lamp fundoscopy, guides~     therapy in pediatric idiopathic intracranial hypertension (IIH) patients; however, it remains~     a limited method of producing quantitative data in evaluating in patients with IIH.~      In this study we intend to compare, by using spectral domain optical coherence tomography~     (OCT), the mean retinal nerve fiber layer thickness and total retinal thickness (RNFLT/TRT)~     of the optic nerve of newly diagnosed IIH children to a control group. This will provide a~     quantitative measure for follow-up and treatment of this patient group.~   "
68842|NCT02665845|"~     The role of steroids in the treatment of severe ulcerative colitis (UC) exacerbation is well~     established and recommended by professional societies. Similarly, 5-aminosalycilates (5-ASA)~     agents in the form of mesalamine/mesalzine are well established proven therapy in~     mild-moderate UC, and the combination of oral 5-ASA with topical (per-rectal enema) 5-ASA was~     shown to be superior to oral 5ASA alone in patients with mild moderate UC. Thus, in most~     cases, when a patient with UC experiences a flare while taking 5-ASA therapy, treatment is~     usually optimized by maximizing the oral dose to 4gr/day and adding topical therapy until the~     flare is controlled. If this is unhelpful, or if the flare is severe to begin with,~     corticosteroids are usually prescribed. However, there are very scarce data comparing~     steroids versus 5-ASA in the treatment of severe UC exacerbation.~      The aim of this study is to compare the efficacy of steroids alone vs. combination of~     steroids + 5-ASA in the treatment of moderate-severe UC exacerbation.~   "
68843|NCT02665832|"~     The purpose of this study is to compare the safety and pharmacokinetic characteristics of~     combination of amlodipine, olmesartan and rosuvastatin and DWJ1351 in healthy male volunteers~   "
68844|NCT02665819|"~     PanCareLIFE Study is a cohort study of patients treated for cancer in childhood, and~     biological case-control study nested in the cohort (WP4) is coordinated by Erasmus MC-Sophia~     Children's Hospital in Holland.~      Ensure optimal patient quality of life throughout his life is a priority for the research~     teams. PanCareLIFE Study also aims to identify the factors that predispose to impaired~     quality of life. It is in this light that will be offered to patients a quality of life~     questionnaires during the period of treatment and then periodically during long-term~     follow-up.~   "
68845|NCT02665806|"~     This study is designed to compare ciclesonide nasal spray once daily with fluticasone~     propionate aquas nasal spray BD, which is commonly prescribed in patients with nasal~     polyposis, in order to relieve symptoms of these patients.~   "
68846|NCT02665793|"~     Food allergy affects up to 10% of the population. The mainstay of management involves dietary~     avoidance and provision of rescue medication in the event of an accidental reaction. The~     Integrated approaches to food allergen and allergy management (iFAAM) collaboration is an~     EU-funded academic/clinical/industry consortium with the aim to improve allergen risk~     management including food labelling. Much of this work requires the validation of the minimum~     'eliciting dose' for the food-allergic population and how this can be translated into risk~     management.~      A number of studies (including iFAAM and the TRACE study - NCT01429896) have assessed the~     eliciting dose for peanut allergic patients, using food challenges where peanut-allergic~     individuals are eat incremental doses of peanut under strict medical supervision.~      In this extension study, peanut-allergic subjects will have undergone (in a cross-over~     manner) three double-blind, placebo-controlled food challenges to peanut:~        1. incremental doses of peanut in a water-continuous matrix;~        2. incremental doses of peanut baked into a cookie biscuit;~        3. a single dose of peanut in a water-continuous matrix.~      The differences in eliciting dose, symptom pattern and underlying physiological mechanisms~     will provide essential data on how the presentation and consumption of peanut affects the~     amount needed to trigger an allergic reaction, to inform industry and food regulators as to~     how to best protect the food-allergic population.~   "
68847|NCT02665780|"~     This study evaluates the short and long term effect of dental cleaning and mouthrinsing for~     the treatment of bad breath~   "
68848|NCT02665767|"~     The investigators investigated the feasibility of the clinical application of~     novice-practitioner-performed/offsite-mentor-guided ultrasonography for identifying the~     appendix.~   "
68849|NCT02665754|"~     The investigators will perform double-blinded placebo-controlled randomized clinical trial~     which evaluates the efficacy and safety of allergen-specific intralymphatic immunotherapy~     (ILIT) for allergens including Dermatophagoides farinae (Df), Dermatophagoides pteronyssinus~     (Dp), cat, and dog that are sensitized and provoke rhinitis-related symptoms in patients with~     allergic rhinitis (AR), using allergen extracts for allergen-specific immunotherapy (Tyrosine~     S, Allergy Therapeutic, West Sussex, UK).~   "
68850|NCT02665741|"~     The goal of this study is to compare two FDA approved distal colonoscope attachment devices,~     in order to identify which device can increase adenoma detection rate the most without~     increasing procedure time or risk.~   "
68851|NCT02665728|"~     The objective of this study is to evaluate the safety and efficacy of BLI400 laxative in~     constipated adolescent subjects.~   "
68852|NCT02665715|"~     Roux-en-Y gastric bypass (RYGB) accelerates nutrient delivery to the small intestine causing~     higher peak blood glucose concentration early after meal intake. In the late postprandial~     period (1 1⁄2-2 h) nadir blood glucose level is lower compared with before operation. In some~     patients, overt postprandial hypoglycaemia develops, and is typically reported as a~     complication 1-5 years postoperatively, when maximal weight loss has been obtained. The~     pathophysiology of postprandial hypoglycaemia involves inappropriate hyper-secretion of~     insulin associated with exaggerated secretion of the gut hormone glucagon-like peptide-1~     (GLP-1) leading to a mismatch between glucose absorption rate, insulin secretion and whole~     body glucose disposal. We hypothesize that lowering carbohydrate content of meals reduces~     postprandial glucose excursions whereby GLP-1 and insulin secretion is reduced and reactive~     hypoglycemia prevented.~   "
68853|NCT02665702|"~     The aim of this study is to explore whether endostar combined with NVB and DDP as treatment~     could improve progression-free surial time (PFS) and to evaluate the safety of the~     chemotherapy regimens~   "
68854|NCT02665689|"~     The aim of the prospective randomized study is to investigate whether a intensified diabetic~     control program leads to better final visual acuity and less frequent diabetic ocular~     complications in patients with diabetic retinopathy when compared with a normal diabetic~     treatment.~   "
68856|NCT02665663|"~     Amyotrophic Lateral Sclerosis (ALS) is a neurodegenerative disease with a poor prognosis that~     occurs in adults 64 years on average. Its prevalence is 4 to 6/100 000 inhabitants.~      Swallowing disorders occur during evolution and involve the prognosis of patients in the~     short term by the association of dysphagia with severe malnutrition, and aspiration. The~     issue of phoniatric monitoring is to detect early onset of the swallowing disorders to~     develop strategies for respiratory protection, food adapted to disturbances, and speech~     therapy.~      The objective of this study is to compare the tongue force in patients with amyotrophic~     lateral sclerosis at the time of diagnosis and at the onset of swallowing disorders compared~     to healthy subjects, with the dynamic palatography device developed in the Laboratoire Parole~     et Langage (UMR 7309, CNRS-Université Aix-Marseille, Aix-en-Provence), which allows the~     measurement of the strength and duration of the pression of the tongue on the palate.~   "
68857|NCT02665650|"~     The purpose of this study is to establish a dosing regimen for the combination therapy of~     AFM13 and pembrolizumab (MK-3475) in patients with relapsed or refractory (R/R) Hodgkin~     Lymphoma (HL) and to assess the safety and tolerability of this combination therapy.~   "
68858|NCT02665637|"~     This is a double-blind, two-arm, parallel-group, single-dose study.~   "
68859|NCT02665624|"~     Adequate bowel cleansing is essential for optimal colonoscopic examination. However, none of~     the colonoscopy preparation regimens is safe, efficient and also comfortable. The~     investigators' aim was to determine whether adding stewed apricot juice to senna increases~     patient comfort and improves bowel cleansing during colonoscopy preparation.~   "
68860|NCT02665611|"~     Moma call center will provide unique service -Remote monitoring and support for mental health~     patients .The aim of this reserch is reducing hospitalization and improve adherence, by~     reaching out and there for monitoring very closely .~   "
68861|NCT02665598|"~     Posterior Reversible Encephalopathy Syndrome (PRES) is a clinical-radiological entity, which~     is associated with a variety of clinical conditions. The imaging and clinical findings are~     typically reversible, but many patients still have permanent neurological sequelae with a~     fatal outcome. Up to now there are no consistent conclusions about the factors that affecting~     its prognosis. The objective of our study is to discuss the effects of different causes,~     different imaging findings and laboratory parameters on the prognosis of PRES and deepen the~     understanding of the nature of PRES. This will contribute to predict the prognosis of~     patients with PRES and to further investigate the pathogenesis of PRES so as to guide the~     clinical treatment and follow-up evaluation. A multi-center retrospective case study will be~     performed from January 2016 to July 2017 and a total of 400 patients who meet the criteria~     for PRES diagnosis from 10 sub-centers are anticipated included in this research. Patients~     will be divided into several subgroups according to the etiology. Date will be collected from~     the clinical records，imaging and laboratory data of the patients, including demographic data,~     clinical data, imaging findings, laboratory parameters and follow-up data. During the~     follow-up, MRI and blood biochemical examination will be performed once more. The imaging~     findings of the patients will be assessed by two neuroimaging physicians, any difference~     between them will be agreed upon by consensus. Prognosis of the patients will be assessed by~     using the modified Rankin scale (mRS) scores. All of the above data is saved into the~     database. In this study we will review etiologies and imaging findings, laboratory and~     follow-up data of the patients we selected. Univariate and multivariate analysis will be~     performed within the group and between groups according to the subgroups. Then we will~     discuss the connection between different causes, different imaging findings and laboratory~     parameters and the prognosis of posterior reversible encephalopathy syndrome.~   "
68862|NCT02665585|"~     The aim of the present positive-control study is to analyze and compare the rate of off-table~     subclinical neurological events in two groups of patients submitted to carotid artery~     stenting (CAS) with two different kind of stents, a close-cell stent, and the new~     mesh-covered stent, so to verify if the new model of stent is effective in preventing~     postprocedural carotid plaque embolism.~   "
68863|NCT02665572|"~     In this study, investigators will prospectively evaluate the outcome of renal transplantation~     into a defunctionalized bladder by comparing direct transplantation into this~     defunctionalized bladder and pre-transplant programmed bladder cycling.~   "
68864|NCT02665559|"~     Testosterone deficiency is classically associated with the development of metabolic syndrome,~     osteoporosis, erectile disorder and / or a reduced libido, a depressive syndrome and~     alteration of the quality of patients life.~      Chronicity of HIV infection leads to several disorders as fever, chronic stress, weight loss~     and cachexia which are the cause of hypogonadotropic hypogonadism. On the other hand,~     abnormal secretion of cytokines, secondary to the infection may alter the Leydig cells~     causing a hypergonadotropic hypogonadism and disrupts steroidogenesis. Cases of testicular~     invasion by lymphoma or Kaposi's syndromes have also been described.~      The advent of antiretroviral therapy has reduced the prevalence of hypogonadism in patients~     infected with HIV that is currently about 20%. This prevalence remains about 20%, regardless~     of the antiretroviral therapy and CD4-T cell count.~      No study to our knowledge has so far assessed exhaustively the clinical features, biological,~     therapeutic and paraclinical of hypotestosteronemiae while assessing the level of total serum~     testosterone, SHBG and serum free testosterone, among HIV infected patients in the European~     population.~   "
68865|NCT02665546|"~     Pulmonary Langerhans Histiocytosis Cells (PLCH) is characterized by infiltration of~     Langerhans cells and formation of loose granulomas with lymphocytic infiltrate and formation~     of nodular and cystic lesions on chest CT, and is often associated with smoking.~     Functionally, there may be obstructive and / or restrictive defect, with reduced carbon~     monoxide diffusing capacity. Dyspnea and lower exercise tolerance are common in PLCH, but~     exercise capacity in this disease is poorly understood and has not been compared to controls.~     Besides, the mechanisms involved in limiting exercise are poorly understood and cover~     multiple factors such as change in gas exchange, pulmonary hypertension (PH), dynamic~     hyperinflation, physical deconditioning and left heart failure. The involvement of pulmonary~     circulation in PLCH has unknown prevalence, but contributes to the symptoms. In the PH~     classification, PLCH belongs to the group 5, of multifactorial etiology. The definition of~     the presence and contribution of dyspnea mechanisms in different severities of PLCH is~     important to understanding the disease and individualization of treatment. The objective of~     the study is to evaluate the exercise capacity of patients with HCLP, and determinate~     mechanisms of dyspnea and lower exercise tolerance beyond its impact on quality of life.~   "
68866|NCT02665533|"~     The main aim of the study is to investigate the pre-emptive effect of dexamethasone and~     diclofenac associated to codeine to prevent the pain, edema and limited mouth opening at the~     extraction of third molar.~   "
68867|NCT02665520|"~     Autologous Fat Derived Stem Cell treatment of ED.~      To assess safety and primary efficacy of stem cell infusion in refractory ED.~      To investigate the success rate and durability of success of using this new therapy in~     management of moderate and sever cases of erectile dysfunction.~   "
68868|NCT02665507|"~     Back pain is a common complaint among pilots. Current treatments include physiotherapy and~     chiropractic manipulations. Low-level laser irradiation (LLLI) in the visible to~     near-infrared range was shown to reduce neck and low back pain.~      The purpose of the study is to evaluate the efficacy of Light Therapy for treatment of back~     pain in pilots.~   "
68869|NCT02665494|"~     Multi-centric, observational, prospective study, designed for pts with diagnosis of~     all-stages cholangiocarcinoma, including rare and crossing-over histological types, and~     excluding gallbladder cancer and ampullary carcinoma.~   "
68870|NCT02665481|"~     The purpose of this research is to examine the effects of four interventions on age-related~     cognitive decline in healthy older adults. The investigators will examine the effects of~     Mindfulness Based Stress Reduction (MBSR) psychotherapy, multi-component intensity-based~     aerobic exercise, and their combination, compared to a discussion group.~   "
68871|NCT02665468|"~     On October 1, 2016, the VHA Office of Telehealth and the Connected Health Office will merge~     to create a single entity that will be responsible for the implementation and evaluation of~     eHealth technologies across the healthcare system. In an effort to successfully fulfill its~     mission, the new combined Connected Health/Telehealth Office is pledging $1,100,000 for an~     eHealth Partnered Evaluation Initiative (PEI) to support the further implementation of~     eHealth technologies across VHA, and to measure their impacts on dimensions of access and~     other outcomes. Developed in close consultation with leadership of the new office, the~     proposed objectives of the eHealth PEI are to (1) implement a patient-level supported~     adoption intervention for secure messaging and evaluate the impact of secure messaging use~     through a rapid, one-year randomized trial; and (2) evaluate the initial rollout of VHA's~     automated telehealth text messaging system to Veterans and clinical team members.~   "
68872|NCT02665455|"~     To evaluate the point accuracy of the FreeStyle Libre Flash Glucose Monitoring System when~     used at home by pregnant women with diabetes.~   "
68873|NCT02665442|"~     This Study is designed to determine the outcome and effect of implementation of Esophageal~     Stylet as a strategy to minimize the risk of esophageal injury during the atrial fibrillation~     catheter ablation procedure.~   "
68874|NCT02665429|"~     This is a study of emergency physicians' prescribing patterns related to opioid (narcotic)~     medications. We are trying to determine whether giving providers access to their own~     prescribing data influences their prescribing patterns.~   "
68875|NCT02665416|"~     This open-label, two-part study is designed to assess the safety, PK, PD, and therapeutic~     activity of RO7009789 in combination with vanucizumab or bevacizumab in participants with~     metastatic solid tumors not amenable to standard treatment. Part I (dose escalation) is~     designed to establish the maximum tolerated dose (MTD) of RO7009789 in this combination. Part~     II (expansion) is intended to characterize the safety and tolerability of RO7009789 in~     combination with bevacizumab among indication-specific cohorts and to confirm the recommended~     dose.~   "
68876|NCT02665403|"~     Hospitalization is a stressful and threatening experience, which can be emotionally~     devastating to children. Hospital play interventions have been widely used to prepare~     children for invasive medical procedures and hospitalization. Nevertheless, there is an~     imperative need for rigorous empirical scrutiny of the effectiveness of hospital play~     interventions, in particular, using play activities to ease the psychological burden of~     hospitalized children. This study tested the effectiveness of play interventions to reduce~     anxiety and negative emotions in hospitalized children. A non-equivalent control group~     pre-test and post-test, between subjects design was conducted in the two largest acute-care~     public hospitals in Hong Kong. A total of 304 Chinese children (ages 3-12) admitted for~     treatments in these two hospitals were invited to participate in the study. Of the 304~     paediatric patients, 154 received hospital play interventions and 150 received usual care.~   "
68877|NCT02665390|"~     This study is focus on percutaneous cryoablation,which was for the treatment of medically~     inoperable Peripheral lung cancer.The patients who were agreed to attend the study will~     accept the operation. After the operations,they will follow up according to the plan.~   "
68878|NCT02665377|"~     Prospective, blinded, placebo-controlled trial. Patients: Adult patients (>18 years of age)~     undergoing de novo Htx, with a preoperative GFR > 30ml/min, not receiving an ABO-incompatible~     organ with an ischemia time of > 6 hours. A donor age > 70 years is an exclusion criteria.~      Intervention: Infusion of h-ANP fore five days, starting at the induction of anesthesia.~      Outcome: Kidney function, evaluated with serum creatinine day 1-7 and kidney clearance, 4-5~     Days after Htx plus after 3 and 12 months.~   "
68879|NCT02665364|"~     The safety and immunogenicity of the IFN-Kinoid (IFN-K) have been evaluated in a phase I~     clinical study conducted in subjects with SLE. Preliminary results were promising.~      The principal aim of the present study is to confirm the neutralization of the interferon~     gene signature and the clinical efficacy of IFN-K in subjects with SLE. In addition, the~     immune responses and the safety elicited by IFN-K will also be evaluated.~   "
68880|NCT02665351|"~     Peramivir is the first intravenous neuraminidase inhibitor (NAI) available for treatment of~     uncomplicated influenza in adults. Data from placebo-controlled trials in outpatients have~     shown antiviral efficacy, safety, and tolerability. Although the unmet need for intravenous~     therapy lies mainly with patients hospitalized with complicated diseases, such data are~     limited because of feasibility and ethical considerations for placebo-controlled studies.~      In this study, the investigators aimed to examine more specifically treatment effects of~     peramivir in adults hospitalized with influenza-associated lower respiratory tract~     complications (LRTC). Such findings may have important implications on clinical management.~   "
68892|NCT02665195|"~     This study is being done to learn more about how changes in certain genes may be linked to~     cancer. Some people with cancer got their disease because they inherited an abnormal~     (mutated) gene.~      The researchers of this study want to better understand the risks that are linked to genetic~     changes in these less well-studied genes. By understanding these risks, we believe that~     doctors will be able to give better advice to families with mutations in these genes.~   "
68893|NCT02665182|"~     This is a single-blinded RCT evaluating the value of up-positioning of the testes as~     supportive therapy in patients receiving antimicrobial treatment due to acute bacterial~     orchitis.~   "
81837|NCT02495753|"~     The purpose of this study is to test the hypothesis that vaginal cleansing with~     povidone-iodine solution immediately prior to cesarean delivery reduces postcesarean~     infectious morbidity.~   "
68881|NCT02665338|"~     Cigarette smoking causes significant morbidity and mortality in the United States. Smoking~     cessation is difficult, with the average smoker attempting to quit five times before~     permanent success. Moreover, the majority of smoking quit attempts result in relapse. Brain~     stimulation for smoke cessation is an exciting new area that builds on advancing neuroscience~     knowledge concerning the functional neurocircuitry of addiction. Cortical stimulation can now~     be performed non-invasively by transcranial magnetic stimulation (TMS). Several studies have~     shown that TMS can reduce cue-elicited craving in smokers. Previous research by group has~     shown that a single session of 15 minutes high frequency (10 Hz) repetitive TMS (rTMS) at~     100% motor threshold over the left dorsal lateral prefrontal cortex (DLPFC) can reduce~     cue-induced craving compared to sham TMS. However, the mechanism by which craving is reduced~     by rTMS is poorly understood both at behavioral and neural levels. Neuroimaging studies in~     nicotine dependence have revealed cue-related responses in numerous brain areas, including~     frontal, parietal cortices and subcortical areas. Recently functional magnetic resonance~     imaging (fMRI) studies by the group have shown that cue-induced craving induced brain~     activation in ventral medial prefrontal cortex (VMPFC), including medial frontal, orbital~     frontal and anterior cingulate. This Chair Research Development Fund (CRDF) pilot proposal~     will integrate two new techniques- TMS and fMRI to investigate DLPFC-VMPFC pathway in~     smokers. Using double-masked methods investigators hypothesize that cue-induced exposure will~     induce brain activity in VMPFC, and 15 minutes rTMS over DLPFC will reduce cue-induced~     craving through modulating DLPFC-VMPFC pathway (increased activity DLPFC and decreased~     activity VMPFC).~   "
68882|NCT02665325|"~     Thyroid carcinoma is the common endocrine system malignant neoplasm. At present it has become~     the malignant neoplasm of fastest growing incidence rate. More than 90% thyroid carcinoma is~     thyroid differentiated carcinoma（DTC）. Postoperative oral L-thyroxine suppressing thyroid~     stimulating hormone (TSH) treatment is the standard therapy in DTC patients. While~     TSH-suppressive therapy with L-thyroxine can cause subclinical hyperthyroidism in treatment~     of patients with thyroid differentiated carcinoma. The impact of this therapy on cognitive~     functions and mood have not been systematically studied. The investigators infer the~     subclinical hyperthyroidism caused by TSH-suppressive therapy may impact cognitive function~     and mood disorders in DTC patients. The aim of this study is to explore the possible~     mechanism of cognitive function impairment in the course of TSH-suppressive therapy by rat~     model of total thyroidectomy + TSH-suppressive therapy and clinical trials. The result of~     this study may provide clinical and experimental basis for the side effects risk result form~     TSH-suppressive therapy in DTC patients.~   "
68883|NCT02665312|"~     observational prospective study, designed for patients with colorectal cancer receiving for~     the first time 5-FU or capecitabine, with or without other chemotherapy combinations.~   "
68884|NCT02665299|"~     When the DNA inside of human cells undergoes certain alterations (mutations), the cells may~     develop into a cancer. The cancer cells may shed this DNA into the blood stream. This~     circulating tumor DNA (ctDNA) can be detected by very sensitive, specialized laboratory~     tests. Measurement of ctDNA has been shown to be useful for following patients with known~     cancer. It has also been found in the circulation of some patients with early stage cancer.~     The purpose of this study is to examine blood specimens for the presence of ctDNA in~     individuals without known cancer who are scheduled to undergo a screening or diagnostic~     colonoscopy in order to see if the ctDNA test can detect a cancer or precancerous condition~     at a very early stage before the patient becomes symptomatic. The results of this study~     should help define the role of ctDNA in the detection of early stage colon cancer and to~     define how sensitive it is (i.e. how well it picks up cancer when it is present) and how~     specific it is (i.e. how often is ctDNA found in patients with benign diseases or no~     abnormalities).~   "
68885|NCT02665286|"~     Low back pain is a common cause of visit to emergency department. It is not clear if skeletal~     muscle relaxants are of benefit for patients with acute low back pain. This is a randomized~     study to determine if skeletal muscle relaxants, when combined with naproxen, improve~     outcomes more than naproxen alone~   "
68886|NCT02665273|"~     This is a randomized, sham-controlled study of greater occipital nerve block (GONB) using~     bupivacaine 0.5% for emergency department patients with acute migraine. Patients are only~     enrolled if they fail first line therapy with metoclopramide.~   "
68887|NCT02665260|"~     The purpose of this study is to determine if cantharidin is a safe and effective treatment~     for molluscum contagiosum in kids~   "
68888|NCT02665247|"~     The purpose of this pilot study is to assess the impact of sleep workshops on sleep, mood,~     anxiety and well-being measures in a sample of college students. College students have a high~     prevalence of sleep problems including poor sleep hygiene, volitional sleep deprivation, and~     insomnia. Sleep disorders in college students negatively affect mood, social functioning,~     physical safety, and academic performance. Rarely recognized by the students themselves,~     these conditions are therefore often untreated. Participants in this study will be randomly~     assigned to receive the College Sleep Improvement Plan (C-SIP) or a control session.~     Participants will be asked to track their sleep as well as complete questionnaires; a subset~     of participants will be asked to wear an activity monitor.~   "
68889|NCT02665234|"~     The purpose of this study is to assess the safety and efficacy of Tavilermide Ophthalmic~     Solution compared with Placebo Ophthalmic Solution in treating the signs and symptoms of dry~     eye disease.~   "
68890|NCT02665221|"~     The primary purpose of this single center, randomized, open label study in relapsing Multiple~     Sclerosis (MS) patients on PLEGRIDY (peginterferon beta-1a) is to assess the effect of~     Preparation H (phenylephrine) Maximum Strength Cream compared to no topical treatment of~     injection site erythema after PLEGRIDY injection.~   "
68891|NCT02665208|"~     The primary purpose of this study is to understand the feasibility of a text messaging~     intervention developed by the National Cancer Institute, known as Smokefreetxt, to improve~     smoking cessation among opiate and/or alcohol dependent participants discharged from an~     inpatient detoxification unit and enrolled in an office-based buprenorphine program patients~     (OBBP). Participants will be randomized to 1) treatment as usual (TAU) comprised of~     informational pamphlets and information for a 1800 quit line; and a prescription for a~     nicotine replacement therapy (NRT) (i.e. nicotine replacement patches based on the quantity~     of baseline self-reported smoking, or nicotine replacement gum (2mg) #10, for 28 days which~     is offered routinely to all inpatients at Bellevue at the time of discharge) versus the~     SmokeFreeTXT intervention plus prescriptions for NRT.~   "
68894|NCT02665169|"~     This study evaluates the 6 month exercise intervention (Taiji and gym course) combined with~     free use of communal recreation facilities in fall prevention.~      Morbidity, use of social services and health outcomes of aging women in province of Kuopio,~     Finland are also monitored. The study combines a six months supervised exercise, followed by~     six months free, but unsupervised, use of recreational facilities and observational period of~     second year into total of 2 year follow up duration.~   "
68895|NCT02665156|"~     Objectives and Specific Aims Time efficiency of robot assisted radical cystectomy (RARC) with~     totally intracorporeal stapled orthotopic neobladder remains a main drawback of this~     procedure. According to a recent consensus panel, the benchmark for intracorporeal orthotopic~     neobladder should be 5 hours in high volume centers .~      This prospective single-stage phase 2 trial is designed to assess the time efficiency of~     using robotic stapler versus the conventional motorized staplers (Linear stapler articulated~     Endo GIA™, Covidien) in achieving the target outcome (total operative time <5 hr).~      Perioperative complications (intraoperative and 30-d postoperative complications according to~     the Clavien classification system), 30-d/90-d/ 180-d complication and readmission rates,~     early functional outcomes (time to recovery of urinary continence), 180-d and 360-d~     neobladder stone formation rates will be analyzed to assess the safety and the cost~     effectiveness of the procedure.~   "
68896|NCT02665143|"~     The purpose of this study is to determine if a combination of nintedanib+ induction~     chemotherapy can be an effective strategy for patients where outcome of relapse/refractory~     acute myeloid leukemia (AML) is poor.~   "
68897|NCT02665130|"~     Tai-Chi may be a beneficial form of rehabilitation which is acceptable to the Chinese~     population but no data exist concerning metabolic responses to Tai-Chi in COPD patients.~     Investigators conduct an Randomized controlled trial to evaluate the synergistic effect of a~     Long acting β2-agonists with Tai-Chi as a culturally acceptable form of PR in the Asian~     population. Classical western style pulmonary rehabilitation will serve as a comparator~     Investigators propose a prospective randomized controlled trial in which 120 bronchodilator~     naïve participants (Age 40-80 with GOLD II-IV COPD (post-bronchodilator FEV1 ≥ 25% and <80 %~     of the predicted normal, and a post-bronchodilator FEV1/FVC < 0.70) are randomized to receive~     a 26 weeks course of Indacaterol with either Tai-Chi or conventional Pulmonary~     Rehabilitation. Only participants who are residents in Xingning city (Guangdong Province,~     China) will be recruited.~      Both Tai-Chi and pulmonary rehabilitation will be given by qualified instructors at a rural~     location in southern China (Xingning). A qualified UK Physiotherapist will also be involved~     in the management of pulmonary rehabilitation program to further make sure the high quality~     of pulmonary rehabilitation has been applied. Both arm participants will also receive in an~     open label fashion Indacaterol 150µg qd. for 6 months giving 2 therapy groups~     (Tai-Chi/Indacaterol, pulmonary rehabilitation/Indacaterol). The primary endpoint of this~     study is change in SGRQ between Tai-Chi/Indacaterol and pulmonary rehabilitation/Indacaterol~     at 14 weeks after entry and the secondary endpoints are change in FEV1% and six minute walk~     distance. the planned recruitment will be 120 with a view to obtaining 100 completers. The~     investigators propose the study starts on 31 Dec 2014 and completes on 30 June, 2016.~   "
68898|NCT02665117|"~     Chlorthalidone (CTD) may produce various metabolic disturbances, including hypokalemia,~     activation of Renin-Angiotensin- Aldosterone (RAA) system, oxidative stress, dyslipidemia,~     Fibroblast growth factor 23 (FGF23) synthesis, and magnesium depletion. These factors may~     interact with each other to contribute to the development of insulin resistances and~     metabolic syndrome. Smaller studies have suggested that Potassium magnesium Citrate (KMgCit)~     can ameliorate CTD- induced metabolic side effects independent of correction of hypokalemia.~     This study will tests if KMgCit ameliorates CTD induced metabolic effects independent of~     correction of hypokalemia.~   "
68899|NCT02665104|"~     The primary endpoint of our study is to determine whether neurological symptoms (aphasia,~     paresis, loss of consciousness, numbness) occur after clamping the internal carotid artery,~     and if so, changes showed by transcranial Doppler or INVOS monitor is more sensitive~     regarding the symptoms? Secondary endpoint: the degree of change in the measured parameters~     after the internal carotid artery is clamped, and if there is any difference between the~     operated and non-operated sides?~   "
68900|NCT02665091|"~     Worldwide, about 50% of all new cases of HIV occur in youth between age 15 and 24 years.~     Studies in various countries show that both out of school and in school adolescents and youth~     are engaged in risky sexual behaviors. Peer-based interventions have become a common method~     to effect important health-related behavior changes and address the HIV/AIDS pandemic. This~     study therefore aimed to evaluate the effectiveness of peer education in improving HIV~     knowledge, attitude, and preventive practices among in-school adolescents~   "
68901|NCT02665078|"~     The ex-vivo lung will be evaluated by XLTF-UC180 for localization of the tumor. The~     ultrasound probe will be put on the lung surface in several different directions to obtain~     the cross section with maximum diameter. The ultrasound image with size measurement of the~     tumor will be recorded using an ultrasound scanner (EU-Y0008, OLYMPUS MEDICALSYSTEMS CORP.,~     Tokyo, Japan). Next, the bronchial stump of the specimen will be opened and a small sized~     endotracheal tube will be inserted to inflate and deflate the lung. After inflation of the~     lung, the tumor will be evaluated by XLTF-UC180 to see the difference in ultrasound images~     between deflated and inflated lung. After ultrasound evaluation, the specimen will be~     delivered directly to the pathology laboratory and the actual tumor size and histological~     diagnosis will be determined. In addition, we will evaluate the differences between US image~     and pathological morphology using HE slides of lung tumor. We will work together with the~     surgical team to confirm sign off of specimens.~   "
68902|NCT02665065|"~     The primary objective of this study is to demonstrate the efficacy of Iomab-B, in conjunction~     with a Reduced Intensity Conditioning (RIC) regimen and protocol-specified allogeneic~     hematopoietic stem cell transplant (HCT), versus Conventional Care.~   "
68916|NCT02664883|"~     This pilot research trial studies the use of the Myeloid Derived Suppressor Cells Clinical~     Assay in finding and monitoring kidney cancer. Studying samples of blood and urine from~     patients with kidney cancer in the laboratory may aid doctors in the early detection of~     cancer, monitor tumor response to therapy, detect the presence of occult spreading of~     disease, and identify early return of disease.~   "
90146|NCT02387203|"~     The purpose of this study is to determine the impact of antibiotic therapy on the disease~     progression and overall survival of patients with Pseudomyxoma Peritonei (PMP).~   "
68903|NCT02665052|"~     Loss of arm use and strength are common problems after stroke that greatly affects~     independence in activities of daily living. Arm rehabilitation using robot-assisted~     repetitive task training has shown to improve motor recovery. However, this type of exercise~     cannot be done at home as these devices are large and expensive. This study will test whether~     a more portable, less costly, non-robotic repetitive training device called Bilateral Arm~     Training with Rhythmic Auditory Cuing (BATRAC) performed at home with a tele-rehabilitation~     format will lead to improvement in arm and hand use in patients with chronic stroke. The~     investigators plan to test the effectiveness of home based tele-rehabilitation with the~     BATRAC compared to a clinic based approach.~   "
68904|NCT02665039|"~     This study aim to compare the efficacy, safety and quality of life of vinflunine/gemcitabine~     and carboplatin/gemcitabine in patients with metastatic urothelial cancer and impaired renal~     function.~   "
68905|NCT02665026|"~     The purpose of this study is to evaluate the appropriate timing to do preventive ileostomy~     closure after total mesorectal excision of rectal cancer. To evaluate the effectiveness and~     safety of preventive ileostomy closure at different time (12 weeks / 24 weeks after radical~     resection of rectal carcinoma). This study was expected to demonstrate that the early~     preventive ileostomy closure after total mesorectal excision of rectal cancer does not~     increase the risk of complications.~   "
68906|NCT02665013|"~     This trial will assess the effectiveness of a tailored message intervention on decreasing~     infant undervaccination.~   "
68907|NCT02665000|"~     1.1 Aim The investigators wish to validate a structured training program for junior residents~     to enhance their learning curves in performing laparoscopic appendectomy.~      1.2 Hypothesis To introduce a structured laparoscopic appendectomy training program and~     validate its efficacy with the validated GOALS scoring system.~   "
68908|NCT02664987|"~     This study is planned to investigate the pain control status in cancer patients in 6 South~     East Asian countries through evaluation of prescription pattern of analgesics, satisfaction~     of pain control, quality of life and assessment of the adequacy of pain control and~     relationship among these factors in cancer patients with pain. Cancer pain is undermanaged~     and it is hoped that this study will be used as a reference for effective cancer pain~     management in these countries.~   "
68909|NCT02664974|"~     Phase III, medical, multicentric, controlled, open label, two-parallel groups, randomized,~     clinical trial.~      The aim of this study is to evaluate the efficacy of home enteral nutrition on the~     nutritional status, the quality of life and tolerance to chemotherapy, in malnourished~     patients who undergo major gastrointestinal surgery for malignancy (oesophagus, stomach,~     pancreas, biliary tract). Patients were randomized to receive either home enteral nutrition~     (HEN, treatment group) or nutritional counselling (control group).~   "
68910|NCT02664961|"~     The purpose of the study is to determine the overall response rate of single agent TRC105 and~     the combination of TRC105 and bevacizumab in patients with refractory GTN (including~     choriocarcinoma, placental site trophoblastic tumor (PSTT), and epithelioid trophoblastic~     tumor (ETT)). Up to 30 patients will be treated.~   "
68911|NCT02664948|"~     The study is a quasi-randomized controlled trial conducted in a Danish University Hospital~     including older patients admitted to Emergency Department (ED). 'Early geriatric follow-up'~     is a multidisciplinary geriatric service provided to older patients who are discharged to~     their home. They receive hospital-visits by a multidisciplinary team no later than 24 hours~     after discharge (except on sundays). The team is consisting of a physician and a nurse both~     with geriatric expertise. The physician is responsible for the clinical patient care. The~     team is available seven days per week/12 hours per day and 24 hour on-call. In the patient's~     home, the team has the possibility to perform diagnosing and treatment by assessments,~     medication review, blood tests, subcutaneous fluid therapy, blood transfusions, intravenous~     antibiotics, rehabilitation and social arrangements. A discharge hand-over supports the~     caregivers and the GP.~   "
68912|NCT02664935|"~     The trial consists of a series of parallel multi-centre single arm phase II trial arms, each~     testing an experimental targeted drug in a population stratified by multiple pre-specified~     actionable target putative biomarkers. The primary objective is to evaluate whether there is~     a signal of activity in each drug-(putative)biomarker cohort separately. A Bayesian adaptive~     design is adopted to achieve this objective and statistical details are given in the~     Protocol.~   "
68913|NCT02664922|"~     The purpose of this study is to compare different combinations of anesthetic drugs (cause~     loss of sensation) in terms of effectiveness, adverse effects, pain relief, and patient~     comfort for cardiac electrophysiology procedures. In addition, the investigators are studying~     the different anesthetic combinations to determine the best approach in terms of~     identification and treatment of arrhythmias.~   "
68914|NCT02664909|"~     This study is a double-blinded placebo-controlled clinical trial evaluating the efficacy of 1~     gram of topically applied tranexamic acid vs. saline placebo for the reduction of transfusion~     following hip hemiarthroplasty surgery.~   "
68915|NCT02664896|"~     Recently, the medical community has learned damage to the knee joint may be one of many~     possible reasons for pain in knee osteoarthritis. Psychological factors and other aspects of~     brain function seem to play an important role in the pain experience. Although research~     studies have examined these factors on an individual basis, no study has examined all of~     these factors in the same population. Furthermore, some measures of brain function- having to~     do with perception of the painful body part- have yet to be examined in knee osteoarthritis.~     The investigators plan to study many of these variables in a group of people with knee~     osteoarthritis, as well in some healthy controls (without knee pain), in order to establish~     the relative importance of these measures in contributing to pain, as well as validate new~     measures of perception in people with knee osteoarthritis. We also plan to use a statistical~     tool- known as latent profile analysis- to look at subgroups of knee osteoarthritis pain. The~     hypothesis is that different people experience pain in knee osteoarthritis for different~     reasons. This study will be the first study to use all of these different variables- which~     can be reproduced in a clinical setting- to look for different subgroups of knee~     osteoarthritis pain. Ultimately, the goal is to help clinicians better prioritize and target~     interventions to individual patients. The investigators believe this will lead to better~     outcomes and fewer treatment complications currently associates with pharmaceutical and~     surgical interventions that are widely used to treat knee osteoarthritis.~   "
68917|NCT02664870|"~     Osteoarthritis is a condition that causes joints in the human body to deteriorate over time.~     This condition affects more than 250 million people around the globe. Currently, the goal of~     treating osteoarthritis involves reducing the severity and pain that results from the~     disease. The ultimate goal of this study is to identify patients with pre-arthritic joints~     (before symptoms or disease characteristics appear) in an effort to find and use treatments~     that stop or slow the disease. Joints are filled with a naturally occurring liquid known as~     synovial fluid. Molecules (biomarkers) and genetic expression of various cell types within~     synovial joint fluid may serve as measures of onset and progression of osteoarthritis. These~     samples have the potential to improve diagnosis, classification, and treatment, possibly~     changing the natural history of this debilitating disease. The purpose of this study is to~     develop a collection of synovial fluid samples from the shoulder, hip and knee for the~     analysis of biomarkers and cellular and genetic components therein to better understand the~     pre-arthritic joint, progression to disease, and response to interventions.~   "
68918|NCT02664857|"~     In this study, effect of vitamin D supplementation on postoperative pain and~     sedation-agitation will investigate. Children with mental motor retardation between 7-17 age~     which dental treatment will be performed under general anaesthesia will be included in this~     study. 600 IU vitamin D will apply to group D per orally during 12 weeks. Group P will not~     take anything during 12 weeks. At first day and end of the 12 weeks, serum vitamin D,~     calcium, alkaline phosphatase, terminal telopeptide C(β-CTX) level will evaluate. At the end~     of the 12 weeks general anaesthesia will be performed for teeth check up, flouring, scaling~     polishing, tooth extraction, filling applications, amputations, root canal treatment. After~     then postoperative pain, sedation and agitation will be evaluate. All data will be~     statistically evaluate at the end of the study.~   "
68919|NCT02664844|"~     In obese adolescents, energy expenditure (EE) of chronic high intensity muscular exercise (>~     70% VO2max) conducted one hour before a meal causes an anorectic effect at lunch and dinner~     the same day. The effect on food intake of the distribution of this exercise into two~     sessions during 24h remains to be determined. In addition, a multidisciplinary load of~     obesity generates a loss of body weight in the short term, which we do not know the effects~     on energy balance. To our knowledge, the impact of weight loss on the anorectic effect of~     muscle exercise is unknown.~   "
68920|NCT02664831|"~     This is a prospective, observational study of inflammatory mechanisms and lipid metabolism~     after resuscitation from cardiac arrest during targeted temperature management. Investigators~     are focusing on elucidating the activity of immune cells after resuscitation and on two~     biochemical pathways. The first is neuregulin-1 (NRG-1), a growth factor regulating cell~     resistance to oxidative stress, cell survival and proliferation. The second relates to lipid~     peroxidation and pro-inflammatory lipid precursors. Participants will undergo blood sampling~     during 7 days following cardiac arrest, and analyses performed. Patient characteristics,~     clinical circumstances, and outcomes will be recorded and their associations with these~     inflammatory pathways characterized.~   "
68921|NCT02664818|"~     The purpose of this study is to assess clinical characteristics, treatment, and outcome of~     patients hospitalized with heart failure in China and compared those with other registries~   "
68922|NCT02664805|"~     To compare the efficacy of twice daily applications of LEO 124249 ointment with LEO 124249~     ointment vehicle for up to 8 weeks in the treatment of subjects with chronic hand eczema.~   "
68923|NCT02664792|"~     To evaluate the diagnostic accuracy of the 18Fluor-fluorodeoxyglucose ([18F]FDG) in the~     Positron Emission Tomography/Computed Tomography (PET/CT) as compared to mediastinoscopy for~     staging of non-small cel lung carcinoma.~   "
68924|NCT02664779|"~     Background: Arrhythmia recognition is a fundamental skill for the provider of advanced life~     support (ALS). Acquire it is difficult, leading to the birth of systematic methods in an~     attempt to simplify and optimize, however, it has not compared the effectiveness among the~     three methods with more evidence among professionals with varying degrees of medical training~     (ALS Workshop participants).~      Objective: To determine and compare the effectiveness of the three most widespread and with~     more evidence systematic methods (10, 6 and 4 steps) for the recognition of arrhythmias in a~     short-term and its perceived easiness among ALS workshop participants.~      Methods / design: Educational Cuasi experimental trial with pre and post intervention~     measurement, blind, with randomized allocation, in 84 ALS workshop participants. Three~     systematic methods to recognize arrhythmias will be taught and their effectiveness to~     diagnose in a short-term and its perceived easiness will be measured and compared.~   "
68925|NCT02664766|"~     The purpose of this research is to examine the effects of long-term aerobic exercise of~     moderate intensity on psychological, physiological, biochemical, physiological and~     alcohol-related parameters in heavy drinkers, in order to investigate possible biochemical~     mechanisms by which exercise may be a healthy alternative to alcohol abuse.~   "
68926|NCT02664753|"~     The primary objective of this study is to compare 28 day mortality rates between septic shock~     patients with acute renal insufficiency treated via L-Carnitine (as an adjunct therapy)~     versus a similar group of patients not receiving L-Carnitine adjunct therapy.~   "
68927|NCT02664740|"~     The primary objective of this study is to compare the efficacy of standard treatment~     associated with a topical anti-staphylococcal bacteriophage cocktail versus standard~     treatment plus placebo for diabetic foot ulcers monoinfected by methicillin-resistant or~     susceptible S. aureus (MRSA or MSSA) as measured by the relative reduction in wound surface~     area (%) at 12 weeks.~   "
68928|NCT02664727|"~     The purpose of this research is to examine the effects of exercise of different intensities~     on psychological, physiological, biochemical, physiological and alcohol-related parameters in~     individuals with alcohol use disorders (heavy drinkers and alcoholic patients) in order to~     investigate possible biochemical mechanisms by which exercise may be a healthy alternative to~     alcohol abuse. For that purpose, a control group of individuals that do not exceed the limits~     for moderate alcohol use will be included.~   "
69151|NCT02661815|"~     Participants with Ovarian, Fallopian Tube, or Peritoneal Cancer that has recurred within 12~     months of prior treatment that includes Platinum Chemotherapy are invited to take part in~     this study. This research study is studying a combination of a new chemotherapy drug called~     Ricolinostat together with the chemotherapy Paclitaxel and a drug called Bevacizumab as a~     possible treatment for this diagnosis.~   "
68929|NCT02664714|"~     The aim of this study is to evaluate if the training of pelvic floor muscles, which~     associates an individualized treatment progressing to a group treatment, would be more~     effective than an individualized training only or groups only.~      Methods: Randomized controlled study which will be done from January to December of 2016, on~     Laboratory of Women's Health Research, Federal University of São Carlos-SP, Brazil.~      Inclusion criteria: women with stress UI, older than 18 years old. The sample size~     calculation was performed using the GPower Software (3.1.5, Germany) and it was estimated a~     sample of 30 women in each group. The volunteers will be assessed before the intervention by~     a urinary symptoms evaluation form, King's Health Questionnaire, miccional diary, PERFECT~     scheme and perineometry.~      After the evaluation will be performed the randomization of the volunteers by a blinded~     investigator and the volunteers will be allocated into three groups:~      Group 1: Individualized Training Group 2: Individualized training with progression to group~     training Group 3: Group training only~      For all groups it will be used the same protocol that was prepared according to the~     recommendations of the American College of Sports Medicine. Later, volunteers will be~     reassessed after 12 treatments, three months and six months (from the discharge date). It~     will be added in the reassessment the Self-efficacy Scale for Pelvic Floor Exercises~     Practice.~      Primary outcome: severity measures of the King's Health Questionnaire.~      Secondary outcome: miccional diary, PERFECT scheme, perineometry and Self-efficacy scale for~     Pelvic Floor Exercises Practice. Data normality will be tested by the Shapiro-Wilk test (SPSS~     19.0). The comparison between the evaluations will be performed by ANOVA, and the comparison~     between groups will be performed by Student t-test (independent measures). In order to~     measure the practical significance of the data, the effect size and the confidence interval~     (CI) will be calculated. A 5% significance level will be assumed. This study was approved by~     the Research Ethics Committee of the Federal University of São Carlos, São Carlos- SP, Brazil~     (Protocol 1207393).~   "
68930|NCT02664701|"~     The primary objective of this study is to evaluate the efficacy of a program of 6 sessions of~     Cognitive Behavioural Group Therapy (CBGT) (as compared to 6 sessions of Individual~     Supportive Therapy (IST)) designed for preventing repeat suicide attempts at 12 months~     post-psychotherapy in adults admitted to inpatient care for suicide attempts.~   "
68931|NCT02664688|"~     The purpose of this study is to compare the effectiveness of pain control and functional~     improvement in patients with degenerative spondylolisthesis treated with lumbar~     stabilization exercises vs flexor exercises (williams exercises)~   "
68932|NCT02664675|"~     Recent data found that peri-implantitis may differ from periodontitis at the histological~     level in terms of extent and composition of the cellular components. From human biopsies, it~     has been shown a deeper apical extension of the inflammatory cell infiltrate and a larger~     proportion of granulocytes and macrophages in peri-implantitis lesions compared to~     periodontitis lesions. Following experimental peri-implantitis, it has been observed a~     continuing bone loss around dental implants after ligature removal; whereas, such a~     progression was not observed around teeth after cessation of the experimental periodontitis.~     The factors influencing the recruitment and the activation of osteoclasts in both diseases~     have not been compared yet.~      Hypothesis : The more rapid and more severe alveolar bone destruction occurring in~     peri-implantitis compared to periodontitis is due at least in part to differences in the~     inflammatory process in these diseases.~      Aim: to study the cytokine profile produced by gingival explants from periodontitis or~     peri-implantitis sites and to test the consequences on alteration of bone remodelling~     activity using in vitro approach.~      Materials and methods The investigators will establish a collection of human gingival samples~     from patients undergoing surgical treatment of periodontitis or peri-implantitis. The~     investigators will test pro-inflammatory cytokines and chemokines release and consequences on~     osteoclast differentiation and activity.~   "
68933|NCT02664662|"~     For the past few years, the survival rate of breast cancer improved due to the advancement of~     surgery techniques and popularization of cancer screening. However, prolonged survival rate~     is definitely not equal to achieving a sound quality of life among breast cancer survivors.~     The health status of cancer survivors might deteriorate according to the severe side effect~     of multiple therapies.~      Health literacy is the ability to access, understand, evaluate and communication information~     as a way to promote and maintain health. Therefore, good health literacy raise the quality of~     life of breast cancer survivors by a good competence in searching and using medical~     resources. Moreover, how to improve health literacy after cancer surgery becomes an important~     part recently. Even if the most fundamental concept has promoted for decades, the clinical~     workers still use the identical education of medical care after surgery for breast cancer~     survivors. However, the identical education is not appropriate for each of patients. In fact,~     each of breast cancer survivors has the different cancer stage leading to accept different~     therapy and producing different side effect. Besides, the background and the role of life are~     very different from each other. Because of the above reasons, the aim of the study is going~     to develop a tailored rehabilitated education, which fit for each breast cancer patients~     after surgery in clinic. At the same time, the health literacy ability might be improved by~     tailored rehabilitated education. When health literacy level is raised, the breast cancer~     survivors have a good quality of life and beautiful health status.~   "
68934|NCT02664649|"~     ATLANTIS is a multicenter, phase IIIb, prospective, open-label, randomized trial.~      The objective of this study is to demonstrate superiority of a strategy of anticoagulation~     with apixaban (Anti-Xa Group) as compared to the current standard of care in patients who~     have undergone a successful TAVI procedure.~      The randomization is stratified according to the presence or not of a mandatory indication~     for anticoagulation for a reason other than the TAVI procedure (e.g. atrial fibrillation or~     DVT/PE).~   "
68935|NCT02664636|"~     The main objective is to develop models for the cortical reorganization of motor areas and~     inter-hemispheric equilibrium in the early phase of post stroke recovery evaluated by the~     fNIRS technique from day 0 to day 60 (day 0 being the day of inclusion in the study) and to~     correlate the latter with the early phases of motor recovery over the same period, as~     measured by the test Fugl-Meyer.~   "
68936|NCT02664623|"~     The main objective of this study is to measure effectiveness at 6 months of personalized~     dietary advice versus dietary counseling via delivery of a standard advice sheet for~     optimizing dietary calcium intake (assessed by a food survey based on CIQUAL* data) in MS~     patients with ambulatory monitoring.~      *CIQUAL Data: Table of nutritional food composition available on the ANSES (National Agency~     for Sanitary Security of Food, Environment and Labour) website, published by the Observatory~     of the Nutritional Quality of Foods. This table includes 1,500 sheets of 58 nutritional~     components. The data is integrated into the software for calculating ingesta (DATAMEAL) at~     the Nîmes University Hospital.~   "
69152|NCT02661802|"~     The purpose of this study was to evaluate the acute effects of oxygen supplementation during~     a submaximal exercise test in patients with Eisenmenger's Syndrome.~   "
71609|NCT02629614|"~     This study evaluates the safety and effectiveness of the Cala ONE device to aid in the~     symptomatic relief of hand tremors in adult essential tremor subjects. This study is a~     prospective, randomized, double-blinded, sham-controlled study.~   "
68937|NCT02664610|"~     One of the most powerful predictors of stroke is hypertension, with estimates of~     approximately 33% of adults in the United States experiencing this condition. Hypertension is~     significantly more prevalent in African Americans compared to European Americans.~     Importantly, hypertension is a modifiable stroke risk factor.~      This proposal will use a community-based participatory research approach to perform a~     randomized trial of a mobile phone text-messaging intervention to reduce high blood pressure~     in an urban African American community in Flint, Michigan.~   "
68938|NCT02664597|"~     Background : About 25% of adnexal masses remain indeterminate after transvaginal~     ultrasonography, as evidenced by the published literature. According to a multicenter study~     conducted in France by Huchon et al., surgery is mainly indicated based on tumor size and~     ultrasonographic appearances and a high rate of benignity is finally found at pathology~     (83.3%). MRI is the most accurate second-line imaging technique for characterizing adnexal~     masses with an accuracy>95%. However, among physicians, a debate exists on the relevance of~     MR imaging to characterize adnexal masses possibly due to the absence of standardization of~     the MR report. In 2013, the first MR scoring system for adnexal masses named ADNEXMR score~     was developed and found to be accurate, with an AUROC>0.94 to distinguish benign from~     malignant adnexal masses. Indeed, our hypothesis is that ADNEXMR score that relays the~     radiologist's suspicion of malignancy to clinician has the potential aim of improving patient~     management, in particular by limiting the number of patients undergoing inappropriate~     surgery.~      Main objective: To compare the rate of inappropriate surgery that occurs when patients are~     managed according to the therapeutic strategy based on ADNEXMR score with the therapeutic~     strategy performed in clinical routine.~      Primary endpoint: The rate of inappropriate surgical intervention during the two first months~     after MR imaging (i.e. unnecessary diagnostic surgery for benign lesions and incomplete~     staging for borderline or invasive cancer).~      Study design:~        -  The study is a prospective multicenter randomized diagnostic study. 606 patients will be~          included by 8 hospitals (16 centers).~        -  Total duration of the study is 36 months with one year for patient inclusions.~        -  At D0, following informed written consent, patients will be randomized in one of two~          groups (intervention group or control group). In the intervention group, patients will~          undergo a pelvic MR imaging (1.5T or 3T) as routinely performed, including morphological~          sequences (T2, T1 with and without fat suppression and T1 after dynamic gadolinium~          injection) and functional sequences (perfusion and diffusion-weighted sequences).~          Prospectively, a senior radiologist analyzes the different MR criteria to characterize~          adnexal masses. The reader will classify the mass using ADNEXMR SCORING system and the~          patient will be managed according to the score. In control group, the complex adnexal~          mass will be managed according to the standard strategy and treatment plan routinely~          used by the multidisciplinary team. Clinical, biological, ultrasonographic and/or MR~          data and the type of treatment will be recorded. If a surgery is required, surgical~          procedure will be performed within the two months after initial diagnostic imaging (as~          routinely recommended).~      At M6/M12, follow-up will be performed. If the lesion has increased or changed with~     suspicious criteria, surgery will be performed as routinely recommended in both groups.~      At M24, adnexal masses status will be recorded by clinical and imaging follow up.~   "
68939|NCT02664584|"~     Background:~      Cardiovascular disease (CVD), osteoporosis and dementia are chronic diseases of ageing that~     impact adversely on the lives of those affected and have major health, social and economic~     consequences. A number of factors are considered to be implicated in these diseases, ranging~     from the more established factors to those that are less well recognised. Lifestyle factors~     such as diet, body weight, smoking, physical activity and years of education are acknowledged~     as risk factors for the development of these chronic diseases of aging. Emerging research~     suggests that elevated homocysteine and/or sub-optimal status of the metabolically related~     B-vitamins (folate, vitamin B12, B6 and riboflavin) may be associated with a higher risk of~     age-related disease. The interplay between relevant genetic and nutrient factors~     (gene-nutrient interactions) is considered to be highly relevant in the development (and~     prevention) of chronic diseases of ageing, however this relatively new area of research is as~     yet poorly understood. The collection of clinical, lifestyle, nutritional and genetic data on~     large numbers of patients would permit the investigation of those nutrients which interact~     with specific genes to increase the likelihood of a person developing chronic diseases of~     ageing.~      Aim:~      The aim of the TUDA study is to collect detailed clinical, lifestyle, dietary, genetic and~     biochemical data to investigate gene-nutrient interactions (particularly from the perspective~     of the B-vitamins and vitamin D/calcium) in the development of CVD, osteoporosis and dementia~     by studying older adults exhibiting the early stages of these common diseases, namely~     hypertension, low bone mineral density, and early memory loss, respectively.~      Secondary aim (follow up TUDA investigation):~      The aim of this longitudinal investigation is to re-assess clinical, nutritional, genetic and~     biochemical factors in relation to the progression of disease outcomes in TUDA study~     participants, in subsequent years after initial investigation.~      Study design:~      A total of 6000 non-institutionalised older Irish people aged over 60 years with early~     predictors of either dementia, stroke and osteoporosis (namely early memory loss, high blood~     pressure and low bone mineral density, respectively) recruited from three centres (St James's~     Hospital Dublin, Ulster University Coleraine and The Clinical Translational Research and~     Innovation Centre (C-TRIC), Londonderry) across Ireland. Non-fasting blood samples were~     collected from all subjects and routine blood biochemistry profiles and biomarkers of~     relevance to B vitamin and vitamin D status were measured. Supplement use was recorded and a~     targeted food frequency questionnaire was used to record dietary intakes of specific vitamins~     of interest (folate, B12, B6, riboflavin and D) from major food sources, particularly~     fortified foods. Physiological function tests including blood pressure, bone health (DXA~     scans) and cognitive function tests and anthropometric measures were also taken.~   "
68940|NCT02664571|"~     The main objective of this study is to compare the distribution of Florbetaben (NEURACEQ:~     FBB) in the brain in amyloid cerebral angiopathy (ACA) manifested by isolated hemosiderosis~     in non-demented patients with that observed in healthy subjects, patients with ACA and with~     lobar hematoma(s) and patients with Alzheimer's dementia without MRI signs in favor of ACA.~   "
68941|NCT02664558|"~     Ubenimex is being developed for the treatment of pulmonary arterial hypertension (PAH) (World~     Health Organization [WHO] Group 1) to improve exercise capacity and delay clinical worsening.~     This proof-of-concept study is designed as a Phase 2, multicenter, randomized, double-blind,~     placebo controlled study comparing ubenimex with placebo in patients with PAH (WHO Group 1)~     and have a WHO/New York Heart Association (NYHA) Functional Classification (WHO/NYHA-FC) of~     II or III. The Primary Objectives for the study are:~        -  To evaluate the efficacy of ubenimex in patients with PAH (WHO Group 1).~        -  To evaluate the safety and tolerability of ubenimex in patients with WHO Group 1 PAH.~   "
68942|NCT02664545|"~     The goal of this trial is to compare the efficacy of the Bridge-Enhanced Anterior Cruciate~     Ligament Repair (BEAR™) technique with the current method of treatment for anterior cruciate~     ligament (ACL) injuries, ACL reconstruction.~   "
68943|NCT02664532|"~     The purpose of this prospective open labeled randomized study was to compare the~     laryngoscopic glottis view as well as ease of intubation between the two blades in~     routine intubations in non-difficult airways.~   "
68944|NCT02664519|"~     Patients with chronic kidney disease (CKD) experience fatigue and exercise intolerance.~     Increased oxidative stress in CKD may be a contributing factor. The role of impaired muscle~     blood flow regulation has not been fully explored. The investigators hypothesize that~     functional sympatholysis is exaggerated in CKD and this is associated with increased~     oxidative stress. The investigators also hypothesize that exercise training will improve~     functional sympatholysis and oxidative stress~   "
68945|NCT02664506|"~     The aim of this research is to translate a theory of the cognitive relationship between~     verbal short--term memory (STM) and word processing impairments in aphasia to treatment~     approaches for language impairment in aphasia. It has been proposed that the co-occurrence of~     these impairments is due to a disruption of cognitive processes that support both abilities:~     maintenance of activated semantic and phonological representations of words, hereafter the~     'activation--maintenance hypothesis'.~      This hypothesis will be tested in the context of a treatment approach that aims to improve~     word processing and verbal STM abilities.~   "
68946|NCT02664493|"~     -  Several studies have shown that about 30% of transplanted kidneys with stable function~          present with tubule-interstitial mononuclear cell infiltration in protocol biopsies and~          therefore meet criteria for acute rejection. This subclinical rejection (SCR) has also~          been correlated with subsequent chronic allograft nephropathy and allograft dysfunction.~        -  The Banff scheme defines the minimal threshold for acute T-cell mediated rejection as~          infiltration of 25% or more of the renal cortex with five or more mononuclear cells in a~          focus of tubulitis or intimal arteritis (histological indices i2t2 or v1) and refers to~          borderline changes as those with insufficient for a diagnosis of acute T-cell mediated~          rejection, including mild to moderate (<50%) cortical infiltration and one to four~          mononuclear cells per tubule in cross section (i1t1 or i2t1)~        -  No consensus for the treating patients with borderline changes has been reached.~          Borderline changes with graft dysfunction are occasionally routinely treated with~          steroid pulse and, whereas subclinical borderline changes are simply 'ignored'.~          Particularly, a previous study demonstrated that most cases designated borderline by~          histopathology are found to be non-rejection by molecular phenotyping~        -  The aim of this study is to investigate the effect of early steroid pulse therapy for~          the reduction of acute rejection episode during the first year after renal~          transplantation in the patients who will show subclinical borderline changes at 2-week~          protocol biopsy.~   "
68947|NCT02664480|"~     Investigators aimed to investigate whether there is an association between ovulation and~     salivatory alpha amylase (sAA) activity in menstrual cycles during a month period in a group~     of reproductive women.~   "
68948|NCT02664467|"~     In a 3 years longitudinal, observational, multicentre study, about 500 women will be~     recruited and followed-up from early pregnancy (10-15 gestational week) until 12 months after~     delivery. The primary aim of the present study is to systematically explore and characterize~     risk factors for perinatal depression (PND) by prospective sleep assessment (using wrist~     actigraphy, polysomnography and various sleep questionnaires) and blood based analysis of~     potential markers during the perinatal period (Life-ON study). Secondary aims are to explore~     the relationship between specific genetic polymorphisms and PND (substudy Life-ON1), to~     investigate the effectiveness of BLT in treating PND (substudy Life-ON2) and to test whether~     a short term trial of BLT during pregnancy can prevent PND (substudy Life-ON3).~      The characterization of specific predictive and risk factors for PND may substantially~     contribute to improve preventive medical and social strategies for the affected women. The~     study results are expected to promote a better understanding of the relationship between~     sleep disorders and the development of PND and to confirm, in a large sample of women, the~     safety and efficacy of BLT both in prevention and treatment of PND.~   "
68949|NCT02664454|"~     Older patients account for around 10% of the population, of which 57% have a long-term~     illness, and 33% were admitted in the past year.~      Geriatric assessment (GA) is a multidimensional assessment of general health status that can~     help identifying deficiencies and followed by a personalized care plan.~      Assessment and management of elderly patients is a daily concern for the general practitioner~     (GP) but conflicting results have been reported so far relating to the clinical impact of GA~     when applied in the primary care setting.~      This study protocol aims to assess the effect on morbi-mortality of a complex intervention in~     patients aged ≥70 years with chronic conditions in primary care. It aims to demonstrate that~     a GA adapted to primary care, followed by a personalized care plan and combined with~     successful interprofessional collaboration can improve clinically relevant outcomes in~     elderly patients with chronic conditions such as one-year overall mortality, unplanned~     hospital admission, emergency visits, or institutionalization.~      The CEPIA study will also help addressing the issue of whether an improved benefit could be~     achieved from a systematic nurse-led or a case-by-case GP-led GA.~   "
68950|NCT02664441|"~     The proposed multicenter study will test the effect of glucagon-like peptide (GLP)-1 agonist~     exenatide once weekly extended-release (ExQW, Bydureon®) on clinical outcomes and metabolic~     parameters in a double-blind, placebo-controlled 36 week randomized trial with an 18 week~     open label extension. Following baseline testing, 48 patients will be randomly assigned with~     equal allocation to ExQW or matching placebo injection for 36 weeks, followed by an 18 week~     open label extension during which all patients receive ExQW. Changes of weight status, body~     composition, free-living total daily energy expenditure (EE) by doubly labeled water (DLW),~     activity by acetimetry, energy intake (questionnaires and food diary), as well as glucose~     tolerance and hormonal parameters of energy homeostasis and insulin resistance will be~     assessed before treatment and at the end of the placebo-controlled phase (week 36). Activity,~     metabolic outcomes, energy intake will be also assessed at study week 18 (mid treatment of~     randomized study), as well as week 54 (end of open label treatment).~   "
68951|NCT02664428|"~     Study hypothesis: Diet integrated with food prepared with olive, buckwheat, peas and chestnut~     flour as in PreBIOil product combination can modify the gut microbiota and the cholesterol~     metabolism.~      Primary objectives of the study are to assess whether the test product to be able to change:~        1. fecal microbiota profile;~        2. Plasma cholesterol LDL, total, total LDL and HDL ratio;~        3. plasma triglycerides;~        4. Apolipoprotein ApoA-I, ApoB, and Lp.~      Secondary objectives of the study are:~        1. anthropometric indices;~        2. secondary metabolites of polyphenols in human biofluids;~        3. mass spectrometry plasma and urine metabolite profile;~        4. blood glucose and fasting insulin levels; 5,6) C-reactive protein (PRC or hsPRC);~      7) urinary isoprostane F2; 8) oxidized LDL in plasma.~      Study Design: placebo-controlled, randomized, double-blind parallel trial.~      Inclusion criteria: Aged 30-65 years; BMI 20-29,9 kg/m^2. Total Cholesterol 180-240 mg/dl~      Exclusion criteria: Fasting blood glucose >150 mg/dl; triglycerides >500 mg/dl; uncontrolled~     hypertension (blood pressure [BP] >160/100 mm Hg under antihypertensive therapy); any long~     term medical therapy; food intolerances; alcohol intake >5 drinks per day or use of narcotic~     substances; use of dietary supplements, pro or pre- biotics; special diet; pregnancy, tobacco~     smoking.~      Methodology: Determination of eligibility: for each volunteer aged between 30 and 65 years,~     will undergo to clinical and biochemistry evaluation. Clinical visit, clinical tests, and~     blood drawing will be performed after an overnight fasting at visit T-1 at the Casa di Cura~     Eremo di Arco (TN). In this T-1 visit the eligibility will be established and the~     participants will be randomized to receive supplementation with either PreBIOil biscuit~     (90g/day) or Control for 8 weeks in a double-blind manner. Clinical tests, blood drawing, and~     stool and urine collection will be performed during visits at the beginning and end of each~     treatment period (T0 and T1). A 4 day-food diary record will be collected before visits T0,~     at the beginning of T0 and before T1.~      Efficacy Assessments Arterial BP; BMI; ratio of waist to hip circumference; food~     questionnaires; blood sample analysis (total cholesterol, triglycerides, HDL and LDL~     cholesterol, oxidized LDL, serum glucose and insulin, C-RP, Apolipoproteins, Isoprostane;~     urinary and plasma metabolite profiling; fecal microbiota analysis.~      Safety assessments. Adverse events registration.~      Statistical analyses. The differences between the two group will be evaluated with univariate~     and multivariate statistical methods. The medium before and after the intervention will be~     compared with the General Linear Model (ANOVA) for repeated measures or for paired data.~     Simple and multiple linear regressions will be performed to determine the relationships~     between independent variables; also we will run the t-test to evaluate differences in~     compliance detected in the types of supplementation. The results are expressed as mean +/-~     SEM and the differences will be considered significant when P <0.05.~      Duration: Subjects will make three visits (visit T-1, beginning visit T0, and end of~     treatment period visit T1, week 8 from T0). The treatment duration is 8 weeks; a daily~     portion of about 90 g of biscuit is introduced.~   "
68952|NCT02664415|"~     The study will evaluate the safety and therapeutic efficacy of the human monoclonal antibody~     (mAb) VRC-HIVMAB060-00-AB (VRC01), when administered during analytic treatment interruption~     (ATI), in adults who began antiretroviral therapy (ART) during early acute HIV infection.~   "
68953|NCT02664402|"~     Background:~      People undergo many changes when they have a life-threatening illness. Their values may~     change. They may have less fear of illness and death. They may become more spiritual.~     Researchers made a questionnaire called HEALS (Healing Experience During All Life Stressors).~     They want to use it to better understand these positive changes. They hope to provide better~     care for people with serious illnesses.~      Objectives:~      To develop the HEALS tool to better understand psycho-social-spiritual healing in people with~     serious illnesses. Also, to find out how palliative care services help people handle their~     illness or stress.~      Eligibility:~      Adults at least 18 years old at least 91 days after being diagnosed with a life-threatening~     illness. They must be getting:~      Inpatient or outpatient palliative care at NIH Clinical Center OR~      Inpatient palliative care at Suburban Hospital OR~      NIH outpatient palliative care provided at Mobile Medical Care Clinic~      Design:~      Participants will be screened with questions to make sure they are eligible.~      Participants will have 1 individual research session. This will be at the NIH Clinical~     Center.~      Participants will be interviewed by a research team member. They will be asked about changes~     in a person s way of living that might happen during or after a serious illness.~      Participants will be asked for their thoughts and opinions about the questions. They will be~     asked what ideas they may have to make the questions better.~      Interviews will be audiotaped.~      Participants will be asked some questions specific to their care location and team. These are~     to better understand how their services are helping participants.~   "
68954|NCT02664389|"~     Despite relevant clinical and/or familial presentations suggesting a hereditary~     predisposition (early-onset, multiple primary tumors, familial aggregation), targeted genomic~     analysis based on the phenotype are often non contributive. As somatic cancer genes are~     limited, the hypothesis is that the targeted next-generation sequencing of 200 genes,~     selected for their implications in cancers may contribute to the understanding of many~     selected patients' presentation by the identification of germline deleterious mutations, and~     may identified phenotype overlapping and/or mosaicisms. The focus will be put on early-onset~     breast, ovarian, colorectal cancer or pediatric cancers and multiple primary tumors.~   "
68955|NCT02664376|"~     The goal of this study is to determine the prevalence of sarcopenia in a geriatric hospital~     ward.~      Sarcopenia is defined by a loss of muscle mass, loss of muscle strength and loss of muscle~     quality. It is a geriatric syndrome that, to this date, is not systematically tracked in~     clinical practice.~      In order to detect sarcopenia, the investigators will use the operational definition proposed~     by the European Working Group (EWGSOP) involving the measure of three parameters, namely the~     speed of walking, the muscle strength and the measurement of the muscular mass.~   "
69247|NCT02660567|"~     The impacts of using Amr's manoeuvre (cervical traction) on atonic postpartum hemorrhage is a~     randomized controlled, multi-centre study that aims to compare the incidence of post partum~     hemorrhage (PPH> 500 ml blood loss) within the first 24 hours of labor after using Amr's~     maneuver with active management of the third stage versus active management alone~   "
68956|NCT02664363|"~     Newly diagnosed WHO grade IV malignant glioma subjects who are eligible will be enrolled~     following surgery to remove the brain tumor. They will then undergo a leukapheresis to~     harvest cells for the generation of the study drug, Epidermal Growth Factor variant III~     Chimeric Antigen Receptor (EGFRvIII CAR) T cells prior to beginning standard of care (SOC)~     radiation therapy (RT) with temozolomide (TMZ). Once SOC RT with TMZ is completed, subjects~     will return for the post-RT brain imaging assessment, and if stable will start post-RT TMZ~     cycles. Patients will receive up to 3 cycles of dose intensified TMZ prior to receiving the~     EGFRvIII CAR T cells, which will be infused in dose escalation cohorts. Following a one month~     delay between cycles, the subject will resume post-RT cycles of TMZ and be monitored with~     blood work and brain imaging as per SOC. Once the maximally tolerated dose (MTD) is reached~     in the dose escalation cohorts, an expanded cohort of 12 subjects will be enrolled to obtain~     a more precise estimate of the probability of unacceptable toxicity and to track the EGFRvIII~     CAR T cells using 111 Indium (111In) labeling. Computed Tomography (CT) will be done on days~     1, 2, and 3 post-infusion to determine intracerebral (IC) localization.~   "
68957|NCT02664350|"~     Pain is one of the most burdensome symptoms associated with cancer and its treatment, and~     opioids are the cornerstone of clinical pain management in cancer patients. Yet, individual~     patient responses to opioids vary widely, and the patient's genotype contributes to this~     variability. Specifically, cytochrome P450 2D6 (CYP2D6) genotype has important relevance for~     response to opioid analgesics that depend on CYP2D6 for bioactivation. Poor metabolizers~     (PMs) have lower concentrations of active metabolites of codeine (morphine), tramadol~     (O-desmethyltramadol), oxycodone (oxymorphone), and hydrocodone (hydromorphone), compared to~     extensive metabolizers (EMs). Morphine and O-desmethyltramadol have 200-fold greater affinity~     for the µ-opioid receptor than the parent compound, whereas oxymorphone and hydromorphone~     have 40-fold and 10-fold higher receptor affinity compared to their parent compounds,~     respectively. Consequently, PMs may fail to derive pain relief from these opioids compared to~     EMs. Interestingly, the occurrence of side effects may not differ between PMs and EMs so that~     while PMs may get little to no pain relief from certain opioid analgesics, they may still~     experience troublesome adverse effects. Intermediate metabolizers (IMs) are also expected to~     have reduced analgesic response based on their significant reduction in enzyme activity.~     Conversely, individuals with the UM phenotype may have toxic concentrations of active opioid~     metabolites, with reports of life-threatening toxicity and death. The µ-opioid receptor gene~     (OPRM1) is the primary binding site for endogenous opioid peptides and opioid analgesics, and~     may have additional contributions to opioid response. The investigators propose to examine~     the effect of CYP2D6 genotype-guided pain management on cancer pain control in study~     participants and the additional effect of the OPRM1 genotype on response to opioids.~   "
68958|NCT02664337|"~     This study is an observational study to test and validate a questionnaire and statistical~     model used to determine patient preferences regarding treatment for any one of 11~     musculoskeletal conditions: hip arthritis, knee arthritis, hip labral tears and~     femoroacetabular impingement (FAI), osteochondritis dissecans, Achilles tendon rupture,~     patellofemoral dislocation, distal radius fracture, and fractures of the hip, ankle, tibia,~     and proximal humerus. This study aims to understand how multiple treatment variables,~     including pain, rehabilitation time, cost, and choice of surgical versus non-surgical~     intervention, impact patients' decision-making processes and ultimate choice of treatment.~   "
68959|NCT02664324|"~     The primary objective of this feasibility study is to evaluate the functionality (e.g., as~     defined by the primary endpoints) of the fully integrated Multiple Sclerosis Performance Test~     (MSPT) device, when used by unsupervised participants with MS, or related conditions, with a~     broad range of disability, in multi-clinical-care environments. Secondary objectives include:~     Participant perception of usability of device; Participant satisfaction with the device;~     Ascertain the impact of different clinical environments on device usability; Ascertain impact~     of assistive devices in usability of device; Ascertain functionality of Bluetooth remote as~     compared with manual timing.~   "
68960|NCT02664311|"~     This is a randomized prospective study comparing outcomes of pulmonary vein isolation using~     conventional and jet ventilation.~   "
68961|NCT02664298|"~     Edentulism is often associated with a negative psychosocial impact. The concept of prosthetic~     rehabilitation in which a prosthesis is supported by osseointegrated implants, was first~     introduced in the late 1960s by Brånemark et al. and offers an interesting alternative to~     removable prosthesis. However, for patients with a severely atrophic maxilla or mandible,~     cranial bone grafting of the jaw is required to increase bone width and height necessary for~     implant insertion. An active collaboration between the surgeons from the Oral and~     Maxillofacial Department and the prosthodontist from the Department of Dentistry has been~     established for continuous quality improvement of the concept of (immediate/delayed) implant~     loading in patients requiring cranial bone grafts to augment their severely atrophic jawbone.~      The investigators aim to develop a prospective database registering (immediate/delayed)~     implant loading data of all patients eligible according to the protocol. Patient~     demographics, surgical, dental, prosthetic and patient satisfaction parameters are collected~     during consecutive visits within the framework of routine practice.~      Development of a database registering immediate functional loading data secondary to cranial~     bone-grafting of a severely atrophic jaw, will provide more information about potential~     patient, surgical and prosthetic factors influencing long-term biological and mechanical~     stability, as well as patient satisfaction. Moreover, registration of those results could~     function as a measurement of quality of care, and could be used for sample size calculation~     for future large prospective trials.~   "
68962|NCT02664285|"~     The aim of this study is to determine the surgical site infection rate and the patient's~     satisfaction for closure of subcutaneous tissue versus non closure of subcutaneous tissue~     after cesarean delivery in women with diabetes mellitus.~   "
68963|NCT02664272|"~     Multicenter, observational study to evaluate if there is a difference between the final~     position of the femoral stem and the last trial rasp when using the SL-PLUS™ MIA Ti/HA~     femoral hip stem with the appropriate set of instruments.~   "
68964|NCT02664259|"~     The purpose of this study is to evaluate the feasibility,efficacy and safety of ultrathin~     bronchoscopy(UTB) combined with virtual bronchoscopic navigation(VBN) and endobronchial~     ultrasound(EBUS) for the diagnosis of peripheral pulmonary lesions (PPLs) without~     radiographic fluoroscopy.~   "
68965|NCT02664246|"~     This review article have included about ten thousand patients undergoing percutaneous~     coronary intervention (PCI), aim to identify the incidence of CIN in actual, find some new~     risk factors and the protecting methods for these factors.~   "
69169|NCT02661581|"~     PLEASED is a 12-month program that aims to help South Asians with type 2 diabetes improve and~     sustain diabetes-related health outcomes e.g. glycemic control, quality of life...) achieved~     from previous short-term diabetes education program. Our goal is to provide a new generation~     of education and support that can be ongoing, patient-driven, and flexible to the dynamic and~     evolving conditions of patients' real-word environment and life circumstances.~   "
68966|NCT02664233|"~     In order to facilitate the evidence-based goal setting and self-monitoring intervention into~     the diabetes education practice, the investigator proposes to use Chronicle Diabetes, an~     electronic system provided available to the American Diabetes Association diabetes education~     programs, to set patient diet and physical activity goals, and connect patient~     self-monitoring information collected from smart phones and fitness trackers to Chronicle~     Diabetes system to facilitate educators' monitoring of patient adherence to their goals.~   "
68967|NCT02664220|"~     The goal of this study is to compare the efficacy of PVI irrigation to no irrigation for~     decreasing postoperative intra-abdominal abscesses in children with perforated appendicitis.~     Additionally, this study aims to verify the safety profile of dilute PVI for intra-abdominal~     irrigation.~   "
68968|NCT02664207|"~     The purpose of this study is to offer pre-natal Myelomeningocele (MMC) repair surgery to~     pregnant women with one of the former surgery exclusion factors~        -  A BMI of 35-40 kg/m2~        -  Diabetes; patients will require good glycemic control~        -  History a previous preterm birth, as long as it was followed by a full term birth~        -  Structural abnormality in the fetus; abnormality must be minor, not increasing the risk~          of prematurity. For example cleft lip and palate, minor ventricular septal defect,~          pyelectasis.~        -  Maternal Rh alloimmunization. Must have a low level of anti-red blood cell antibody that~          is not associated with fetal disease, specifically anti-E < 1:4 or anti-M. Or~          alloimmunization with negative fetal red blood cell antigen status determined by~          amniocentesis.~      We will be extending the Management of Myelomeningocele Study (MOMs) criteria by including~     these factors. Prenatal clinical and outcome information will be collected; safety and~     efficacy will be evaluated~   "
68969|NCT02664194|"~     To evaluate and improve the safety and efficacy of hypothermia as an adjunctive therapy to~     percutaneous coronary intervention in patients with acute myocardial infarction.~   "
68970|NCT02664181|"~     The purpose of this study is to assess whether treatment with the study drug~     tetrahydrouridine-decitabine (THU-Dec) in combination with nivolumab is more effective than~     treatment with nivolumab alone in patients with NSCLC.~      Decitabine is an investigational (experimental) drug that works by depleting DNA~     methyltransferase 1 (DNMT1). DNMT1 is an enzyme, or protein that causes chemical changes,~     often increased in cancer. Blocking DNMT1 has been shown to reduce tumor formation.~     Decitabine is experimental in this study because it is not approved by the Food and Drug~     Administration (FDA) for patients with lung cancer. Decitabine is approved by the FDA for~     treating patients with a blood disease called myelodysplastic syndrome (MDS, a condition~     where the bone marrow does not make blood cells normally).~      THU is an investigational (experimental) drug that works by blocking an enzyme that breaks~     down decitabine. This enzyme is highly expressed in solid tissues of the body, limiting the~     distribution of decitabine into these tissues, including solid cancer tissues. So, THU will~     increase the time cells are exposed to decitabine. The idea is that THU will also increase~     the time that the lung cancer cells are exposed to decitabine. THU is experimental because it~     is also not approved by the FDA, although it has been extensively used in clinical trials,~     including several cancer trials.~   "
68971|NCT02664168|"~     The aim of this study is to assess the prevention of incision healing complications in~     patients undergoing revision TKA and THA treated with either Single-Use NPWT (PICO) compared~     to standard of care dressings (AQUACEL Ag Surgical Dressing). All patients undergoing a~     revision TKA and THA who consent to taking part in the study, and meet the eligibility~     criteria will be included onto the study. Patients will be followed up for a period of up to~     3 months to determine if there are any latent incision healing complications~   "
68972|NCT02664155|"~     In renally impaired patients with acute venous thromboembolism (VTE), standard-of-care (SOC)~     anticoagulation, i.e. heparins-vitamin K antagonists (VKA), at therapeutic dosage is~     associated with an increased risk of thromboembolic and bleeding complications compared to~     patients with normal renal function. Direct oral anticoagulants (DOAs) have been shown to be~     at least as effective and safe as SOC in VTE treatment. But in the clinical trials, moderate~     renally impaired patients were poorly represented and patients with severe renal~     insufficiency not at all. So no dose reduction was considered.~      Surprisingly, DOAs have been approved for VTE treatment in moderate and severe renally~     impaired patients. There is need to evaluate a reduced dose of DOAs for VTE treatment in~     patients with moderate and severe renal insufficiency.~      We plan to evaluate reduced doses of 2 DOAs (apixaban, rivaroxaban) compared to SOC in VTE~     patients with moderate or severe renal insufficiency in terms of net clinical benefit~     (recurrent VTE and major bleeding) at 3 months.~   "
68973|NCT02664142|"~     General anaesthesia (GA) is, according to many definitions, the greatest gift presented to~     the medical art (S. B. Nuland). One of the aims of GA is to achieve the optimal depth of~     anaesthesia and rapid emergence from general anaesthesia. In order to achieve this goal, it~     is necessary to observe the clinical condition of the patient, and at the same time monitor~     the patient's overall condition. With the currently available options of GA management (e.g.~     use of intravenous anaesthetics, strong analgesics and modern volatile anaesthetics, in~     combination with various methods of topical anaesthesia) the importance of methods measuring~     the depth of GA increases. The depth of GA may be defined as a continuous progressive~     decreasing of the central nervous system, together with a decreased reactivity to stimuli. In~     the course of GA, perioperative awareness is detected in 0.1-0.2% of cases. Awakening during~     a surgical procedure may result in significant psychological complications (e.g.~     post-traumatic stress disorder), and the patient may suffer from a serious long-time~     disorder.~   "
68985|NCT02663986|"~     The primary aim of this project is to address the need for an effective school-based~     intervention for elementary school-aged students with Organization, Time Management, and~     Planning (OTMP) deficits by adapting an evidence-supported clinic-based intervention so that~     it can be implemented in school settings. Investigators are learning to adapt an individual,~     clinic based program (OST-C) for children diagnosed with Attention Deficit Hyperactive~     Disorder (ADHD) to children with OTMP problems. Investigators will be collecting data . To~     this end, investigators will be collecting data on implementation (such as feasibility and~     acceptability), program development (what changes to the individual OST-C program were made~     based on findings during this study) and limited outcome data (repeated measures collection~     and pre- and post-treatment collection on a small sample, no control group).~   "
68986|NCT02663973|"~     The principal goal of this study is to describe the epidemiology of breast cancer in the~     Brazilian population~   "
68974|NCT02664129|"~     The deficit of awareness of pathology (or insight) is a common symptom in patients with~     schizophrenia and has a negative impact on the prognosis of the disease. Current treatments~     aren't effective enough on this symptom (Pijnenbord et al., 2013).~      Previous studies have shown a positive impact of videos of patients themselves on insight but~     they lacked power (Davidoff et al., 1998 ; Vikram et al., 2008 ; David et al., 2012). This~     technique needs more investigation. Our study aims to improve the patient's awareness of~     pathology with a video of themselves recorded in the acute phase of their illness. Patients~     will watch this video after clinical stabilization. This is a randomized controlled and~     single blinded trial. A population of 60 patients (30 in each group) will be included. The~     impact on the insight, symptomatology, treatment adherence and functional remission will be~     evaluated.~      The video of patient is useful for a personalized clinical follow-up. Its use for therapeutic~     purposes would be innovative and could be extended to other applications in psychiatry,~     especially as this tool is readily available.~   "
68975|NCT02664116|"~     This research will be conducted to see if the oral drug Cambia is as effective in relieving~     severe migraine headaches as the injectable drug ketorolac.~   "
68976|NCT02664103|"~     Primary Objectives:~        -  To assess the safety for each cohort of patients on a fixed-dose combination pill of~          capecitabine and cyclophosphamide administered at flat dose and with metronomic schedule~          (defined as continuous daily treatment without interruption) in patients with metastatic~          breast cancer.~        -  To assess the pharmacokinetics (PKs) and bioavailability of the fixed-dose combination~          pill of capecitabine and cyclophosphamide administered at different doses/regimens by~          metronomic schedule in patients with metastatic breast cancer.~      Secondary Objectives:~        -  To assess antitumor activity of the fixed-dose combination pill of capecitabine and~          cyclophosphamide administered at different doses/regimens by metronomic schedule in~          patients with metastatic breast cancer given at 3 different doses and schedules (regimen~          1=standard dose twice daily [BID], regimen 2=full dose once daily [OD], regimen 3=low~          dose [OD])~        -  Disease Control Rate (DCR)~        -  Overall Response Rate (ORR)~        -  Time to Progression (TTP) using the Response Evaluation Criteria in Solid Tumors~          (RECIST) criteria (version 1.1).~        -  To evaluate the compliance under treatment.~        -  To describe evolution of toxicities.~        -  To assess safety all along patient's treatment.~   "
68977|NCT02664090|"~     Acute respiratory distress syndrome (ARDS) commonly complicates acute illness in ICU. This~     syndrome is associated with high morbidity and mortality. In management of ARDS patients,~     lung protective ventilation and prone ventilation are key strategies which have shown~     survival benefits in recent years. Prone positioning has been reported to have hemodynamic~     disturbances like hypotension and arrhythmias. The literature till date is unclear with~     regards to acute hemodynamic changes which can happen during initiation of prone ventilation~     ,with a few studies suggesting decreasing cardiac output and a few increasing cardiac output.~     In recent years, trans-esophageal Doppler (TED) has become one of important hemodynamic~     assessment tool due to its minimal invasiveness, ease of use with its clinical utility~     established by various studies both in operation theatres and intensive care units. In~     current study, the investigators would like to evaluate acute hemodynamic effects of prone~     ventilation with TED in patients of acute respiratory distress syndrome (ARDS).~   "
68978|NCT02664077|"~     This study is a randomized, double-blind, post-chemotherapy, adjuvant phase III clinical~     trial. The primary aim of this study is to determine the value of regorafenib in improving~     disease-free survival (DFS). Patients with Stage III (IIIB or IIIC) colon cancer as defined~     by the 7th Edition of the American Joint Committee on Cancer (AJCC) Cancer Staging Manual are~     randomized 1:1 to placebo or the experimental agent regorafenib following completion of at~     least four months of standard adjuvant therapy (e.g., 5-fluorouracil, leucovorin, oxaliplatin~     (FOLFOX) , capecitabine, oxaliplatin (CapeOx), and other).~   "
68979|NCT02664064|"~     The goal of this study is to evaluate an online Diabetes Prevention Program adapted for~     patients with prediabetes in safety net health care settings.~   "
68980|NCT02664051|"~     This is a randomized, double-blind, cross-over study in healthy volunteers. In the first~     part, the duodenum of the participants will be perfused with acid or saline, during which~     intragastric pressure will be monitored to assess activation of the duodenogastric reflex.~     After perfusion, duodenal biopsies will be collected to evaluate mucosal integrity. In the~     second part, healthy volunteers are treated with the mast cell stabilizer disodium~     cromoglycate or with a placebo during 14 days. Subsequently, the duodenum will be perfused~     with acid and intragastric pressure and mucosal integrity will be evaluated.~   "
68981|NCT02664038|"~     Alcohol Use Disorders (AUDs) have a significant public health impact and are highly prevalent~     in Veterans. Alcohol related brain effects on neurocognition (attention, memory and executive~     function) reduce ability to benefit from current treatments. These cognitive impairments are~     especially common in the early phase of recovery, persist over years and get worse with age.~     Recent research suggests that cognitive remediation therapy (CRT) may improve attention,~     memory and executive function in other disorders, and the investigators just completed pilot~     study with AUD Veterans found significantly greater improvements for those receiving CRT. The~     proposed study examines AUD outcomes and neurocognitive improvements when CRT is combined~     with a standardized alcohol treatment. The investigators hypothesize that CRT will improve~     neurocognition and AUD outcomes more than standardized alcohol treatment alone. Findings will~     determine whether CRT augmentation can benefit Veterans with AUDs.~   "
68982|NCT02664025|"~     Teaching technical skills during medical training can lead to some issues, which can concern~     ethical or medico-legal risks. In this context, the vaginal examination (VE) is specific~     because it concerns the genital area and it interferes with obstetrical management.~   "
68983|NCT02664012|"~     The purpose of this study is to measure plasma nicotine uptake parameters, physiological~     measures, and subjective effect measures in smokers during and following a single ad libitum~     use of three menthol electronic cigarettes versus combustible menthol cigarettes and nicotine~     gum.~   "
68984|NCT02663999|"~     This is a single-center, two-period, randomized, open-label, crossover pharmacokinetic (PK)~     study in healthy adult volunteers to evaluate dose proportionality of diazepam nasal spray~     using two dose levels~   "
71610|NCT02629601|"~     This is a 4-week, five-arm, randomized, controlled trial to compare a standard wellness~     incentive program for physical activity to four other designs.~   "
68987|NCT02663960|"~     Anticoagulation is required to prevent clotting in the extracorporeal circuit during~     continuous renal replacement therapy (CRRT). Regional citrate anticoagulation has many~     advantages regarding bleeding risk and filter survival. However, in clinical practice, its~     use worldwide has been limited by cumbersome protocols . In order to establish a simple~     scheme for universal application. In Aug 2015, the investigators have adopted a new protocol~     using a fixed citrate concentration in the filter of about 4 mmol/L (called fixed group for~     short) instead of conventional adjusted citrate doses according to postfilter ionized calcium~     levels of less than 0.4mmol/l (adjusted group), and speculated the abilities on efficacy and~     safety as well as convenience.~   "
68988|NCT02663947|"~     Hydrocephalus is a disturbance of cerebrospinal fluid production, flow and absorption leading~     to intracranial hypertension. Assessment of the change in intracranial pressure after~     ventriculoperitoneal shunt surgery is important in guiding appropriate postoperative~     management. The optic nerve sheath diameter measured using ultrasonography has been verified~     as a non-invasive indicator of intracranial hypertension in various clinical studies. The~     investigators hypothesized that a change in optic nerve sheath diameter detected through~     ultrasonography could help ascertain a reduction in intracranial pressure following~     ventriculoperitoneal shunt surgery in adult patients without the risk of serious~     complications.~   "
68989|NCT02663934|"~     Management and treatment of older persons living with HIV (PLWH) (≥ 50 years old) is becoming~     increasingly more complex as a majority is greater than 50 years old. This proposal will~     conduct a prospective controlled intervention trial to assess the quantitative and~     qualitative effects of a monitored aerobic/resistance exercise (EXS) program compared to a~     social-interaction stretching (SIS) program on brain health (neuropsychological performance~     testing and neuroimaging measurements) in older PLWH. These results could influence public~     health policy by encouraging PLWH to adopt a more physically active lifestyle and stimulate~     the development of effective EXS programs for older PLWH.~   "
68990|NCT02663921|"~     The purpose of this study is to learn more about the potential effects of visible light on~     the skin. More specifically, this study will examine whether an incandescent lamp (light~     bulb) or LED light bulb can cause skin to become darker. Investigators will determine the~     minimum threshold dose required to achieve immediate pigmentation darkening (IPD), persistent~     pigmentation darkening (PPD), and delayed tanning (DT) for Fitzpatrick skin types IV - VI~     utilizing two visible light sources.~   "
68991|NCT02663908|"~     The purpose of this trial is to test if a marketed drug for advanced prostate cancer~     (FIRMAGON) can reduce the risk of cardiovascular complications as compared to another~     marketed drug for advanced prostate cancer (LUPRON DEPOT) in patients with prostate cancer~     and cardiovascular disease.~   "
68992|NCT02663895|"~     This is a prospective open-label trial that will enroll 12 patients with systemic sclerosis~     (SSc) and at least one calcinotic lesion of the hands that is palpable on physical~     examination and also measureable on hand radiographs, at one single center. Each subject will~     receive treprostinil orally for 12 months, and follow-up evaluations will be performed every~     3 months. Our main objective is to determine whether oral treprostinil is safe, and effective~     in reducing calcinosis in patients with SSc. We hypothesize that calcinosis is a result of~     microvascular injury and ischemic damage, and that therefore treprostinil may be beneficial~     in the treatment of calcinosis in patients with SSc.~   "
68993|NCT02663882|"~     The purpose of this study is to learn more about self-control and adults who smoke~     cigarettes. It has been suggested that people can improve self-control by practicing tasks~     that require the use of self-control (such as delaying cigarettes or sitting up as straight~     as possible). The goal of this study is to learn about whether scores on self-control and~     other measures will change after one week of practicing self-control tasks at home. We~     believe that adults who smoke cigarettes will show better self-control after practicing tasks~     for a week.~   "
68994|NCT02663869|"~     Clinical hypotheses:~      The increasing number of people aging with HIV is a matter of fact. Differences in prevalence~     of comorbidities between the general population and HIV-positive patients are mainly driven~     by duration of HIV infection rather than chronological age of HIV+ patients.~      People aging with HIV display heterogeneous health conditions. Host factors and duration of~     HIV infection are associated with increased risk of MM, independently from chronological age~     and these factors are responsible of the prevalence difference of comorbidities and MM in~     comparison to the general population.~      Objectives:~      The study objective is to assess the prevalence of, and risk factors for, individual~     co-morbidities and multi morbidity (MM) between HIV-positive patients with similar duration~     of HIV infection, but 30 years difference. We compared estimates across both groups to a~     matched community-based cohort sampled from the general population.~   "
68995|NCT02663856|"~     Understanding the complexity of aging and frailty in chronic HIV infection motivated Italian~     team members to begin to build a frailty index (FI) including 37 health variables at the~     Modena HIV Metabolic Clinic (MHMC). The validation of FI in HIV patients have been recently~     published, and more data comparing FI in HIV infected vs un-infected people, have been~     presented at international meeting and are at present submitted for publication.~      The research consortium (MHMC, HCC and HHMP) of this study was motivated to begin preliminary~     work in consideration of the similar multidisciplinary approach in Ageing care and capacity~     to address health status in ageing HIV patients using shared definitions of co-morbidities,~     multi-morbidity and measures of Physical Function and Cognition impairment, disability and~     quality of life. The investigators wanted to overcome the major criticism intrinsic in the~     FI, that is the needs to collects many variables not easily available in most HIV centres.~     The the investigators approach is to make patient living with HIV (PLWH), be the source of~     health variables taking advantage of information and communication technologies available~     with smart phones and fitness tracking device, collecting physiological parameters and~     patient related outcomes.~   "
69019|NCT02663544|"~     This randomized controlled feeding trial aims to determine whether the consumption of~     different amounts and types of dairy products affects blood sugar regulation and~     cardiometabolic health in men and women with the metabolic syndrome.~   "
69355|NCT02659150|"~     The purpose of this study is to test the hypothesis that anti-IL-6 therapy is effective for~     reducing plaque inflammation as measured by fluorine-2-deoxy-D-glucose positron emission~     tomography (FDG-PET) in patients with rheumatoid arthritis (RA) who are synthetic~     disease-modifying antirheumatic drugs (dMARD) inadequate responders and are naive to biologic~     therapy.~   "
68996|NCT02663843|"~     Tracheal intubation under general anaesthesia is the gold standard for securing the airway~     and for protecting the lungs against gastric aspiration. The conventional technique involves~     the use of a metal laryngoscope inserted into the mouth to create an air space, to allow~     insertion of an endotracheal tube.~      Alternatively, an oral airway device (called a supraglottic device (SGD)) can be used for~     tracheal intubation. The SGD is first inserted. A fibrescope is inserted down the shaft of~     the SGD and into the trachea. This allows an endotracheal tube (previously pre-loaded onto~     the fibrescope) to be railroaded of the fibrescope and into the trachea. This technique is~     called 'low skill fibreoptic intubation' as the SGD acts as a guide for the fibrescope. Our~     study compares the performance of two SGD: i-gel and air-Q. The investigators will compare~     intubation success rate, insertion rate, and times for SGD insertion and intubation.~   "
68997|NCT02663830|"~     The aim of the study is to evaluate the effect of sildenafil citrate on the pregnancy rate in~     women undergoing induction of ovulation using clomiphene citrate.~   "
68998|NCT02663817|"~     The hypotheses of the study are as follows:~        -  Mass-based inverse optimization in radiotherapy treatment planning will result in a~          reduction of normal tissue and organs at risk (OAR) doses for desired prescription~          therapeutic doses to the targets.~        -  Dose-mass histograms (DMHs) may be more relevant to radiotherapy treatment planning and~          treatment plan assessment than the standard of care, realized through dose-volume~          histograms (DVHs)~   "
68999|NCT02663804|"~     A RCT (randomized controlled trial) comparing 3 different TKA (total knee arthroplasty)~     implant designs and investigating the relation between patient satisfaction and the implant~     geometry.~   "
69000|NCT02663791|"~     Arterial stiffness is an important marker of cardiovascular health. Recent evidence from~     cross-sectional research has suggested it is associated with alcohol consumption. Research~     that employs a longitudinal perspective may be better equipped to evaluate the nature of this~     relationship and in particular to determine whether alcohol consumption is linked to the~     progression of arterial stiffness over time. The current study will consequently implement a~     longitudinal cohort design to evaluate the association between long-term alcohol consumption~     patterns and changes in arterial stiffness. Data will be drawn from the Whitehall II cohort~     study of British civil servants, in which participants completed repeat pulse wave velocity~     (PWV) assessments of arterial stiffness across a four-to-five year interval. Repeat~     measurements of volume of alcohol intake were also recorded for participants, extending back~     across more than two decades. Intake will be categorised in such a way as to distinguish~     between different alcohol consumer types, including non-drinkers and former drinkers. Linear~     mixed effects models will be used with adjustment for potential confounds, such as age,~     diabetes, mean arterial pressure and heart rate. Results from the modelling work will~     illustrate the extent and form of the association between alcohol intake and PWV. This work~     will provide useful insights into the role that alcohol intake plays in the longitudinal~     progression of an important cardiac marker, and it will have implications for our~     understanding of alcohol's relationship to cardiovascular health in the general population.~   "
69001|NCT02663778|"~     This randomized clinical trial targets 248 community-dwelling older adults with impaired~     mobility (i.e. walking slowly; gait speed < 1.20 m/s). The trial compares a 12 week~     standard-plus program of strength, endurance, flexibility plus task specific timing and~     coordination training to a standard 12 week strength, endurance and flexibility program. The~     primary outcome is gait speed at 12 weeks. Secondary and tertiary outcomes represent~     components of the intervention and measures of activity and participation. Delayed and~     sustained effects of the intervention are examined at 24 and 36 weeks.~   "
69002|NCT02663765|"~     Antenatal care is a key strategy for reducing maternal and neonatal morbidity and mortality~     rate because adequate utilization of antenatal health care services is associated with~     improved maternal and neonatal health outcomes. The trend of maternal mortality in developing~     countries has been increasing and various international organizations have reported that an~     important factor related to maternal and infant mortality has been linked to lack of~     antenatal care. According to Federal Ministry of Health, some of the dangers of pregnancy and~     childbirth can be avoided if the pregnant woman attends antenatal regularly. In order to~     decrease these mortality rates, regular antenatal care has to be instituted or reinforced~     which can only be achieved through identifying factors causing poor utilization of antenatal~     care services~   "
69003|NCT02663752|"~     Several previous studies (clinical and non-clinical) hypothesize that treatment with~     deferasirox causes a hematological improvement in transfused patients with low and~     intermediate-1 risk myelodysplastic syndrome. The purpose of this study was to assess the~     presence of genetic biomarkers predictive for hematologic response by the use of gene~     expression profiling of bone marrow aspirates obtained from MDS patients with or without~     hematological response.~   "
69004|NCT02663739|"~     The study is a post-market surveillance study required by Japanese Regulatory Authorities as~     a condition of approval~   "
69005|NCT02663726|"~     There is evidence that yoga has beneficial effects on several aspects of physical and mental~     health. However, few studies have explored the acceptability and health effects of yoga in~     older adults. This preliminary study will explore the effects of a 10-week yoga intervention~     on physical function and quality of life in older adults. Data collected in this study will~     be used to inform the design of a subsequent adequately-powered randomised controlled trial.~   "
69054|NCT02663089|"~     Batefenterol (GSK961081) is a bifunctional bronchodilator that is being developed for the~     treatment of Chronic Obstructive Pulmonary Disease (COPD). Absorption, metabolism and~     excretion of batefenterol have been studied in animals, in vitro, and in previous clinical~     studies; however, the elimination routes and metabolic pathways of batefenterol have not been~     fully elucidated in humans. This is an open-label, single centre, non-randomised, 2-period~     single-sequence crossover, mass balance study to determine total radioactivity (drug related~     material) in plasma, the rate and extent of excretion of total radioactivity in urine and~     faeces and the total recovery of radioactivity of [14C] GSK961081 administered as a single IV~     dose (concomitant with an inhaled non-radiolabelled dose) and a single oral dose, in healthy~     male subjects. A total of 6 healthy male subjects will be enrolled. The duration of each~     subject in the study is up to 11 weeks, which consists of a screening visit, 2 Treatment~     Periods, and a follow up visit.~   "
69006|NCT02663713|"~     Taken together the results from CHARISMA and PEGASUS-TIMI54, it appears that physicians may~     consider extending beyond 1 year or reinitiating treatment with clopidogrel 75 mg od or~     ticagrelor 60mg bid in patients with a prior MI and features of high ischemic and low~     bleeding risk. Comparative clinical or pharmacodynamic studies, however, between clopidogrel~     75 mg od and ticagrelor 60 mg bid in the chronic phase of stable post MI patients have not~     been performed.~      In a platelet substudy of PEGASUS-TIMI 54, 180 patients who had received >4 weeks of study~     medication had platelet reactivity assessment. Ticagrelor 60mg bid achieved high levels of~     peak and trough platelet inhibition in nearly all patients, with similar consistency of~     effect compared to 90mg bid. Platelet reactivity (PRU) was significantly reduced with~     ticagrelor 60mg bid compared to placebo.~      In light of this, we believe that a dedicated pharmacodynamic study of ticagrelor 60 bid mg~     vs clopidogrel 75 mg od in a PEGASUS-like population would be informative for the practicing~     clinician, thus setting the rationale for conducting this specifically designed~     investigation.~      This is a prospective, randomized, single blind, single center, crossover study. Eligible~     patients undergoing P2Y12 receptor antagonist therapy before screening will undergo a 14-day~     minimum washout period before randomization. Following screening/washout period (visit 1),~     patients will be randomized (visit 2, time 0) in 1:1 fashion to either clopidogrel 75 mg od~     or ticagrelor 60 mg bid. Following 14±2 days (visit 3) patients will receive alternate~     treatment for additional 14 days (visit 4). Platelet reactivity assessment will be performed~     with the VerifyNow P2Y12 reaction assay at time 0, prior to first study drug dose. At visit 3~     platelet function will be assessed at 2-4 hours post dose and prior to crossover. At visit 4~     also platelet function will be assessed at 2-4 hours post study drug post dose. All patients~     will receive concomitant aspirin (100 mg/d) and standard secondary prevention medication.~      The primary endpoint is the platelet reactivity measured in P2Y12 reaction units (PRU) at the~     end of the 2 study periods (pre-crossover and post-crossover).~   "
69007|NCT02663700|"~     This study is a phase 1, randomized, double-blind, placebo-controlled, dose escalation trial~     of Sanaria's irradiated sporozoite vaccine (PfSPZ vaccine). The primary objective of this~     protocol is to determine the safety and reactogenicity of the PfSPZ Vaccine in~     malaria-experienced healthy adults. The study duration shall be 34 months and subject~     participation duration shall be 15-26 months.~   "
69008|NCT02663687|"~     This trial is looking to gain information about the safety and tolerability of an~     investigational treatment (SHP623) in healthy adult volunteers. This study will also collect~     pharmacokinetic data (how the body absorbs and breaks down the study drug).~   "
69009|NCT02663674|"~     This is a Phase IV randomized, double-blinded, placebo-controlled study in 1000 individuals~     aged 18 years or older, with community acquired pneumonia (CAP) who meet all eligibility~     criteria in endemic regions. This study is designed to provide data on the effectiveness of~     early antifungal treatment (Fluconazole, 400 mg/day) for coccidioidomycosis pneumonia (also~     referred to as Valley Fever (VF) Pneumonia or acute onset valley fever) vs. placebo in~     subjects with coccidioidomycosis pneumonia. Patients who are prescribed antibacterials by~     their health care provider for acute CAP will be randomized to receive either placebo or 400~     mg/day of fluconazole for 42 days. The primary objective is to assess the clinical response~     of early empiric antifungal therapy with fluconazole at Day 22 in subjects with~     coccidioidomycosis pneumonia and are compliant with the study intervention.~   "
69010|NCT02663661|"~     The type 1 Diabetes (T1D) TrialNet Pathway To Prevention (PTP) Study assesses and recruits~     at-risk subjects into clinical trials aimed at preventing the development of full blown T1D.~     Thousands of first and second degree relatives of persons with T1D are screened for~     autoimmune abnormalities and positive subjects are followed with metabolic and autoantibody~     tests. The investigators' ancillary study us designed to test whether characterization of the~     insulin- glucose-glucagon (IGG) interactions in participants in the PTP study can provide new~     information about the early stages of the disease. When completed, this study will improve~     the understanding of the pathogenesis of the early stages of T1D and provide new quantitative~     tools for prediction and evaluation of insulin-glucagon-glucose interactions relevant to~     individuals at risk for developing T1D, thereby enabling future preventive intervention~     trials.~   "
69011|NCT02663648|"~     This study involves observing the level of cell cycle regulatory gene in patients with~     myeloproliferative disorders(MPD). These disorders include polycythemia vera (PV), essential~     thrombocythemia (ET), myelofibrosis (MF) and chronic myeloid leukemia (CML). The abnormal~     blood and/or bone marrow cells, or materials derived from these abnormal cells, like DNA,~     RNA, protein or plasma will be used in laboratory studies.~      Cell cycle regulatory protein such as cyclins, cyclin-dependent kinases(Cdks) and Cdk~     inhibitors(CKIs) play indispensable roles in processes such as transcription, metabolism and~     stem cell self-renewal. MPD are a group of diseases characterized by abnormally increased~     proliferation of erythroid, megakaryocytic, or granulocytic cells. The pathogenesis was still~     unclear. Detecting the level of cell cycle regulatory protein will be useful to look for the~     possible role in MPD and better understand the cause of MPD.~   "
69012|NCT02663635|"~     A simulated clinical use testing the Save'N'Sound 1mL staked Passive Delivery System with~     add-on extended finger flanges~   "
69013|NCT02663622|"~     This is a multicenter prospective randomized phase IIa/IIb clinical trial designed to~     determine the MTD (Maximum Tolerated Dose) of CD24Fc for acute GVHD (Graft Versus Host~     Disease) prophylaxis.~   "
69014|NCT02663609|"~     Chart review study to collect patient data from medical charts of patients who have been~     treated with Korlym® for the treatment of ACTH independent adrenal Cushing's Syndrome.~   "
69015|NCT02663596|"~     The purpose of this investigation is to evaluate the safety of delivering continuous infusion~     (CI) vancomycin in pediatric CRRT by utilizing CI via by mixing the vancomycin into the CRRT~     solution(s). The secondary objectives are to describe the ability to achieve therapeutic~     vancomycin concentrations by utilizing this new delivery technique.~      Primary Objectives:~      To determine whether delivering continuous infusion vancomycin mixed into the CRRT solution~     can maintain therapeutic levels of drug in patients being treated for proven or suspected~     Gram-positive bacterial infections.~   "
69016|NCT02663583|"~     The goal of this laboratory research study is to learn about symptoms and activity levels of~     patients with OPSCC that receive IMPT or TORS.~   "
69017|NCT02663570|"~     The aim of our study is to investigate the effects of a treatment with melatonin on clinical,~     endocrine and metabolic features in women affected by PCOS. The study group included 40~     patients treatend with 2 mg of melatonin daily for six months. Menstrual pattern,~     anthropometric parameters, hirsutism score, ultrasound ovarian volume and antral follicular~     count, an oral glucose tollerance test and hormonal assays are evaluated before and after~     therapy.~   "
69018|NCT02663557|"~     Stroke is one of the most devastating disorder worldwide. Hypertension has been confirmed to~     be a major modifiable risk factor for stroke.Even the casual visit hypertension has been~     managed ideally,there is still surplus risk for stroke re-attack.The purpose of this study is~     to explore whether variation of 24-hour ambulatory and visit-to-visit blood pressure~     variability (BPV) contribute to recurrent stroke.~   "
69020|NCT02663531|"~     Alzheimer´s disease (AD) in one of the most important causes of dementia and poses a~     considerable challenge in health care. Today, criteria for the diagnosis and the follow up of~     patients with AD mainly rely either on subjective tests or invasive methods. This limits the~     general applicability of the latter test for population screening and underlines the need for~     the identification of easily accessible tools for the identification of high-risk subjects.~     Because of its unique optical properties, the eye offers the possibility of the non-invasive~     assessment of both structural and functional alterations in neuronal tissue. As the~     neuro-retina is part of the brain, it does not come as a surprise that neuro-degenerative~     changes in the brain are accompanied by structural and possibly also functional changes in~     the neuro-retina and the ocular vasculature. The current study seeks to test the hypothesis~     that beside the known anatomical changes, also functional changes can be detected in the~     retina of patients with AD. For this purpose, flicker light induced hyperemia will be~     measured in the retina as a functional test to assess the coupling between neural activity~     and blood flow. Further, structural parameters such as retinal nerve fiber layer thickness~     and function parameters such as ocular blood flow and retinal oxygenation will be assessed~     and compared to age and sex matched controls.~   "
69021|NCT02663518|"~     Multicenter, open-label, phase 1a/1b trial of TTI-621 in subjects with relapsed or refractory~     hematologic malignancies and selected solid tumors.~   "
69022|NCT02663505|"~     Intensive care units are inevitable for high risk surgery and/or high risk patients i.e.~     patients with severe preconditions. However, usually the capacity of these units is limited~     such that at times elective surgery has to be postponed if there is no ICU capacity.~      The aim of this study is to investigate potential influence/risk factors important for ICU~     admission in a university hospital in Germany and develop a risk score. In a second phase the~     risk score for ICU admission will be validated.~   "
69023|NCT02663492|"~     To investigate the effect of percutaneous electrical stimulation on chemotherapy-induced bone~     marrow suppression in patients with lung cancer.~   "
69024|NCT02663479|"~     The purpose of this study is to evaluate the efficacy and safety of a proprietary~     nutraceutical supplement in capsule form over 4 months in treating blood pressure in a group~     of chronic hypertensive subjects that are not receiving any pharmaceutical anti-hypertensive~     agents or other nutraceutical supplements.~   "
69025|NCT02663466|"~     Background. Limberg flap, one of the recently being popularized off-midline closure~     techniques, is widely performed for the treatment of sacrococcygeal pilonidal sinus; however,~     recurrences still can be seen.~      Objective. The aim of this study was to assess the relationship between recurrence and~     off-midline closure errors made in Limberg flap reconstructions.~      Design. A multicenter, matched-case-control study was conducted in three participating~     centers in Turkey.~      Settings. Each hospital's database was searched separately and all patients with and without~     recurrence who underwent LF surgery for primary SPS from January 2008 to July 2015 were~     identified.~      Patients. Sixty patients with recurrent disease (recurrent group, RG) and 120 matched cases~     of recurrence-free patients for at least 5 years following surgery (non-recurrent group, NRG)~     were included to the study.~      Interventions Main outcome measures. According to the off-midline closure concept, LF~     reconstructions were classified into incorrect closures (Type 1, 2 and 3) and correct~     closures (type 4, 5 and 6). Then the two groups were analyzed.~   "
69026|NCT02663453|"~     The purpose of this study is to compare the effects of a multicomponent lipid emulsion~     containing 30% soybean oil, 30% medium-chain triglycerides, 25% olive oil, and 15% fish oil~     with a conventional pure soybean oil lipid emulsion on the incidence of neonatal cholestasis,~     infant growth, infant morbidity and the biochemical assessment of liver enzymes.~   "
69027|NCT02663440|"~     Phase II Trial of Hypofractionated Intensity Modulated Radiation Therapy(IMRT) With~     Temozolomide and Granulocyte-macrophage Colony-stimulating Factor(GM-CSF) for Patients With~     Newly Diagnosed Glioblastoma Multiforme.~   "
69028|NCT02663427|"~     The purpose of this study is to determine whether detection of pepsinogen Ⅰand Ⅱ combined~     with Helicobacter pylori antibody, so-called ABC method , is fit on gastric cancer screening~     in community of Wuxi City.~   "
69029|NCT02663414|"~     The objective of this study is to collect post market data on safety and performance of the~     Atlas Knee System in patients with osteoarthritis (OA) of the medial knee compartment through~     a 24 months post-operative follow-up period.~   "
69030|NCT02663401|"~     This study evaluates the impact of the introduction of a front-of-pack nutrition label on~     fods and beverages sold in a campus cafeteria in France on the nutritional quality of~     purchases. The design involves one site with the intervention and one control site with the~     same consumer and product characteristics.~   "
69031|NCT02663388|"~     The purpose of this study was to evaluate the role of vitamin status and epigenetic~     mechanisms on severe obesity related-complications.~   "
69032|NCT02663375|"~     Post-market registry on ACURATE TA™ Transapical Aortic Bioprosthesis and ACURATE TA™ Delivery~     System implantation in patients presenting severe symptomatic aortic stenosis to collect~     continued surveillance data pertaining to safety and performance of the device.~   "
69033|NCT02663362|"~     The purpose of this study is to develop and refine the techniques for using magnetic~     resonance imaging and magnetic resonance spectroscopy to understand the composition and~     function of the human body~   "
69055|NCT02663076|"~     The multicenter registry will collect clinical data from 2500 patients with non valvular~     atrial fibrillation (NVAF) and chronic kidney disease (eGFR 15-49 mL/min per 1.73 m2).~      The overall objective of this registry is to assess chronic kidney disease (CKD) progression~     and clinical outcomes with regard to anticoagulation strategies in NVAF patients with eGFR~     15-49 mL/min per 1.73 m2 in routine clinical practice.~   "
69056|NCT02663063|"~     The study aims to explore the effects of silver spike point (SSP) treatment on common~     symptoms including pain, breathlessness, nausea/vomiting, dry mouth etc. of terminal cancer~     patients.~   "
69057|NCT02663050|"~     Dysmenorrhea is a common symptom in daily practice of gynecology. Different kind of treatment~     strategies are being held. But invasive and pharmacological therapies have good outcome with~     systemic side effects. Kinesio taping is being widely used in different pain conditions.~     Kinesio taping is a noninvasive and nonpharmacological, easy-to-use intervention method which~     can be used in outpatient practice without systemic side effects.~   "
69034|NCT02663349|"~     Maintenance of employment is dependent upon being able to successfully integrate into one's~     work setting. This can present a significant challenge to individuals with serious mental~     illness, as they typically exhibit impairment in their ability to accurately perceive and~     understand social exchanges. Presently the most established intervention is Social Cognition~     and Interaction Training (SCIT), a 12-week group intervention in which participants learn~     strategies to enhance emotion recognition and to assess the accuracy of their interpretation~     of social interactions. To enhance transfer of training gains to functional outcomes,~     participants will be paired with a social mentor to facilitate completion of homework and to~     ensure that skills are practiced outside of treatment (supported SCIT). The study will~     examine the impact of supported SCIT on social and work role functioning.~      The specific aims are:~        1. To assess the feasibility of providing supported SCIT to individuals with serious mental~          illness who are engaged in compensated work activity.~        2. To assess the impact of supported SCIT on social cognitive skills as well as work and~          social performance.~        3. To assess durability of intervention-induced change 3 months after the end of~          intervention.~      A randomized, active-placebo controlled, parallel groups, single blind study will be~     conducted in which 60 participants between 18-60 with serious mental illness (schizophrenia,~     schizoaffective disorder, and bipolar disorder) are assigned to 12 weeks of supported SCIT or~     an active placebo condition, a computer skills course. Each intervention will consist of two~     1-hour small group training sessions and 1 hour of individualized supported practice of~     skills with a treatment facilitator weekly. Feasibility will be assessed with attendance at~     group and individual sessions. Baseline, post-intervention, and follow-up assessments will~     measure social cognitive abilities and functional outcomes . Potentially confounding~     variables such as symptom severity and outside treatment hours will also be assessed. It is~     hypothesized that supported SCIT will be completed by at least 75% of veterans assigned to~     that condition. The intervention is predicted to improve social cognitive skills and social~     and work performance. Training gains are expected to be sustained 3 months after~     intervention.~   "
69035|NCT02663336|"~     The purpose of this study is to determine the percentage of patients with masked hypertension~     in a population with chronic kidney disease. The investigators goal is to register~     prospectively ambulatory blood pressure measurement results of patients of a nephrological~     outpatient clinic with normal office blood pressure to finally find the percentage of masked~     hypertension in this population.~   "
69036|NCT02663323|"~     MeRes-1 Extend study is designed as prospective, multinational, multicentre, single arm, open~     label, pilot study to assess the safety and performance of the MeRes100 Sirolimus Eluting~     Bioresorbable Vascular Scaffold System (BRS) in subjects with de novo native coronary artery~     lesions. 64 subjects will be enrolled from the 8 centers located in Asia Pacific, Europe,~     Brazil and South Africa. Primary outcome of study will be Proportion of population reporting~     Major Adverse Cardiac Events at 6 months from the day of index Procedure.~   "
69037|NCT02663310|"~     The purpose of this study is to investigate the efficacy of surgical~     decompression/untethering, combined with weight bearing rehabilitation, on neurological~     recovery following chronic spinal cord injury.~   "
69038|NCT02663297|"~     The body has different ways of fighting infection and disease. No single way seems perfect~     for fighting cancer. This research study combines two different ways of fighting disease:~     antibodies and T cells. Antibodies are proteins that protect the body from disease caused by~     bacteria or toxic substances. Antibodies work by binding those bacteria or substances, which~     stops them from growing and causing bad effects. T cells, also called T lymphocytes, are~     special infection-fighting blood cells that can kill other cells, including tumor cells or~     cells that are infected. Both antibodies and T cells have been used to treat patients with~     cancers. They both have shown promise, but neither alone has been sufficient to cure most~     patients. This study is designed to combine both T cells and antibodies to create a more~     effective treatment. The treatment that is being researched is called autologous T lymphocyte~     chimeric antigen receptor cells targeted against the CD30 antigen (ATLCAR.CD30)~     administration.~      In previous studies, it has been shown that a new gene can be put into T cells that will~     increase their ability to recognize and kill cancer cells. A gene is a unit of DNA. Genes~     make up the chemical structure carrying the patient's genetic information that may determine~     human characteristics (i.e., eye color, height and sex). The new gene that is put in the T~     cells in this study makes a piece of an antibody called anti-CD30. This antibody floats~     around in the blood and can detect and stick to cancer cells called lymphoma cells because~     they have a substance on the outside of the cells called CD30. Anti-CD30 antibodies have been~     used to treat people with lymphoma, but have not been strong enough to cure most patients.~     For this study, the anti-CD30 antibody has been changed so that instead of floating free in~     the blood part of it is now joined to the T cells. Only the part of the antibody that sticks~     to the lymphoma cells is attached to the T cells instead of the entire antibody. When an~     antibody is joined to a T cell in this way it is called a chimeric receptor. These CD30~     chimeric (combination) receptor-activated T cells seem to kill some of the tumor, but they do~     not last very long in the body and so their chances of fighting the cancer are unknown.~      The purpose of this research study is to determine a safe dose of the ATLCAR.CD30 cells that~     can be given to subjects after undergoing an autologous transplant. This is the first step in~     determining whether giving ATLCAR.CD30 cells to others with lymphoma in the future will help~     them. The researchers also want to find out what side effects patients will have after they~     receive the ATLCAR.CD30 cells post-transplant. This study will also look at other effects of~     ATLCAR.CD30 cells, including their effect on your cancer and how long they will survive in~     your body.~   "
69039|NCT02663284|"~     A French University team (M. Jeanne, MD, and M. LOGIER, Ph D) have developed a pain~     assessment tool based on the analysis of the variability heart rate which evaluates the~     Analgesia Nociception Index (ANI). This index is intended to give a quantification of pain.~      The aim of the present study is to assess the validity of the ANI parameter in patients with~     Complex Regional Pain Syndrome treated with a nerve block (reversible pain).~   "
69040|NCT02663271|"~     Glioblastoma multiforme (GBM) is the most common and deadliest primary malignant neoplasm of~     the central nervous system in adults. Despite an aggressive multimodality treatment approach~     including surgery, radiation therapy and chemotherapy, overall survival remains poor.~     Novocure has shown that when properly tuned, very low intensity, intermediate frequency~     electric fields (TTFields) stunt the growth of tumor cells. The Optune system (NovoTTFTM~     Therapy) is a portable battery operated device, which produces TTFields within the human body~     by means of surface transducer arrays. The TTFields are applied to the patient by means of~     surface transducer arrays that are electrically insulated, so that resistively coupled~     electric currents are not delivered to the patient. Optune is currently FDA-approved as a~     single modality treatment for recurrent GBM when both surgical and radiotherapy options have~     been exhausted as well as combination with adjuvant temozolomide for newly diagnosed GBM.~      This research study is being performed to determine whether or not TTFields combined with~     pulsed bevacizumab treatment increases overall survival in patients with~     bevacizumab-refractory GBM compared to historical controls treated with continuous~     bevacizumab alone or in combination with other chemotherapy.~   "
69041|NCT02663258|"~     Abbreviated Title: An explorative Phase II study of Anti-PD-1 (Pembrolizumab) in patients~     with advanced melanoma (ADAPTeM)~      Trial Phase: Phase II~      Clinical Indication: Stage III unresectable/stage IV metastatic melanoma~      Trial Type: Exploratory Phase II trial~      Route of administration: Intravenous Pembrolizumab, 200mg, 3weekly~      Trial Blinding: Unblinded; open label Phase II study~      Treatment Groups: All participants treated with Pembrolizumab, 200mg iv, 3weekly~      Number of trial subjects: 40~      Estimated duration of trial: 24 months~      Duration of Participation: 24 months~   "
69077|NCT02662790|"~     The current study aims to investigate the effects of dexamethasone exerted on fetal and~     uteroplacental circulation as measured by Doppler ultrasonography in pregnancies at risk for~     preterm birth after 24 hours of its administration.~   "
69078|NCT02662777|"~     This international, prospective and multicenter registry was designed to collect clinical~     evidence for the endoscopic vacuum treatment using Eso-SPONGE® for anastomotic leakage after~     esophageal resection or iatrogenic or spontaneous esophageal perforation.~   "
69042|NCT02663245|"~     The intensification of the management for the control of glycaemia and other risk factors in~     patients with type 2 diabetes (DM2) results in a reduction of diabetes-related complications.~      The strategy to increase the competences of primary care professionals to improve health care~     has been mainly prompted by the current context of limited resources and restricted access to~     specialty care.~      This study aims to evaluate the effectiveness and cost-effectiveness of an integral~     intervention carried out by primary care professionals with the following components:~        1. detection of patients with poor diabetic control;~        2. introduction of a specific consultation on diabetes followed by virtual and telephone~          specialist support;~        3. introduction of other measures to overcome patients and professionals barriers to~          treatment.~      The main objective of the study is to determine if glycaemic control as measured by the mean~     concentration of HbA1c of poorly controlled patients improves when these patients are~     evaluated and treated in primary care under the integral strategy proposed in this study. The~     INTEGRA project also includes Phase 1 (qualitative research study), which is aimed at~     identifying viable strategies to suppress barriers to treatment; these strategies have been~     included to the intervention study (phase 2).~      Phase 2 is a controlled, quasi-experimental intervention that involves 9 primary care centres~     of 3 regions (Lleida, Girona, Barcelona). The participants are patients with DM2 with poor~     glycaemic control that meet all the inclusion criteria and sign the informed consent. The~     intervention study will have three arms: (1) Control Group; (2) Intervention Group 1~     (diabetes specific consultation + additional measures originated in phase 1; and (3)~     Intervention Group 2 (additional measures originated in phase 1).~      Phase 1 has been conducted during the last 6 months previous to the initiation of the~     proposed intervention study and consisted of a qualitative design (individualized interviews~     with randomly selected patients in each of the participating centers); this qualitative study~     has contributed to design the final intervention applied on phase 2, particularly,~     implementing additional measures as coaching sessions to health professionals of the~     participating centers and automated messaging to patients with reminder and motivational~     objectives.~      Phase 2 consists of a recruitment period of 6 months, followed by a 12-month follow-up for~     each patient~   "
69043|NCT02663232|"~     This is a national, multicenter, cross-sectional epidemiological study in adult Spanish~     participants diagnosed with advanced or metastatic melanoma.~   "
69044|NCT02663219|"~     The purpose of this study is to develop and assess the efficacy of an integrated strategy~     that includes feasible and scalable interventions to identify, recruit, link to care, retain~     in care, attain, and maintain viral suppression among HIV-infected men who have sex with men~     (MSM) in the United States (US).~   "
69045|NCT02663206|"~     To compare the efficacy of peroral endoscopic myotomy and Botulinum toxin injection in~     spastic esophageal disorders.~   "
69046|NCT02663193|"~     The purpose of this study is to characterize the tolerability profiles of enzalutamide and~     abiraterone acetate (with prednisone) -with specific focus on central nervous system (CNS)~     tolerability-and quality of life (QoL) after approximately 2 months of participants starting~     treatment with one of these agents for metastatic castration-resistant prostate cancer~     (mCRPC).~   "
69047|NCT02663180|"~     Depression is a serious mental health disease. It is generally characterized by sadness, loss~     of interest in activities, and decreased energy. Globally, it is estimated that almost 350~     million people suffer from depression. In Saudi Arabia, literature suggested that prevalence~     of depression among boy's secondary school students in Abha city was 38.2%. Another study~     found that the prevalence of depression was 22.4 % as moderate, 7.3 % as severe and 3.7% as~     very severe, with a clear predominance prevalence of depression in girls as in boys (1.5~     times). It is important to assess depression literacy including knowledge and beliefs about~     mental disorders among adolescent. A high level of mental health literacy on depression leads~     to a better understanding and outcomes of depressive disorders. Schools are a typical venue~     in which to embed mental health literacy because the school students are more familiar with~     educational activities. Studies concluded that educational intervention about depression~     literacy and destigmatization improves knowledge and may decrease stigma. Further research,~     intervention and activism are needed in the field of mental health in Arab countries to~     improve awareness of mental health problems.~      Objectives: This study is aimed to measure the effect of educational intervention program~     about depression among secondary schools in Jazan city on depression literacy and stigma~     during the academic year 2015-2016.~      The intervention: the intervention will held at each selected intervention school separately.~     The program will be over 2 weeks intervention as the following:~        -  Educational strategies: 2 Lecture about depression 30 minutes supported by group~          discussion, brochures and display of posters with mental-health slogans on depression in~          the schools.~        -  Contact strategies: the investigators will show a video of a young male who had been~          diagnosed (i.e., not an actor) with depression.~      Benefits:~      * The intervention group will join educational intervention program they expected to benefit~     from the program through increase their depression literacy and improve depression stigma,~     and control group will not join any form of intervention.~      Risk: There is no expected risk for participating in the study.~      Consent: Three Informed Consents forms will be signed from students, guardians and school~     manager.~   "
69048|NCT02663167|"~     The purpose of this study is to evaluate the feasibility and effectiveness of~     Internet-delivered Cognitive Behavior Therapy (ICBT) for children (7-11 years) with~     Obsessive-Compulsive Disorder (OCD).~   "
69049|NCT02663154|"~     Postoperative nausea and vomiting (PONV) is one of the most common postoperative~     complications of general anesthesia in pediatrics. Pediatric rates of nausea and vomiting are~     approximately double those of adult patients. Aromatherapy has recently been shown to reduce~     PONV in adults, but the effect in paediatric patients is unknown. The goal of this study is~     to determine the feasibility of a large-scale study in the paediatric population.~   "
69050|NCT02663141|"~     The aim of this study is to determine whether oral losartan is effective in the treatment of~     diabetic macular edema (DME) as an adjuvant for intravitreal bevacizumab (IVB).~   "
69051|NCT02663128|"~     The purpose of this study is to measure how much of a new tablet formulation of lanabecestat~     gets into the blood stream and how long it takes the body to get rid of it, compared to the~     current tablet formulation of lanabecestat. The effect of a high fat meal on how quickly the~     body absorbs the new tablet formulation will also be evaluated. In addition any side effects~     of the study drug using both the new and current tablet formulations will be evaluated. The~     study will last about 22 days, with screening required within 30 days prior to the start of~     the study.~   "
69052|NCT02663115|"~     Project aim is to quantify the influence of a severe therapy-refractory heart failure caused~     by ischemic or dilative myocardiopathy on the function of the diaphragm, its molecular~     biological parameters and on the M. vastus lateralis. The control group consists of patients~     with coronary artery disease (CAD) and normal left ventricular ejection fraction indicated~     for coronary artery bypass graft surgery (CABG) Differences in the geneses of heart failure~     (ischemic vs. dilative cardiomyopathy) will be evaluated during analysis. The~     ubiquitin-proteasome signaling pathway is considered as a central issue for the mechanism of~     the analyses muscle catabolism.~   "
69053|NCT02663102|"~     The purpose of this study is collect safety information on the use of Fluarix Tetra according~     to the approved PI, over a period of 6 years from children (over 3 years of age) and adults~     in Korea.~   "
69079|NCT02662764|"~     Patients who meet all inclusion and exclusion criteria at screening and following surgery~     will receive the Zalviso System™ and evaluate its usability and functionality for up to 72~     hours.~   "
69080|NCT02662751|"~     The main objective of this study is to compare two post-stroke/TIA (transient ischemic~     attack) imaging strategies in terms of the number of clinically important (i.e. requiring~     specific treatment according to current recommendations) lesions detected. The first strategy~     is the current/usual strategy in each participating centre and the second strategy consists~     in starting the post-stroke/TIA imaging assessment by a whole-body, low-dose angiography and~     subsequently resorting to elements of the usual strategy if required.~   "
69058|NCT02663037|"~     Background: The delivery of targeted, patient-centered care for a population with~     heterogeneous healthcare needs while moderating costs is a key challenge in healthcare.~     Segmentation of patient populations based on clinically distinguishing features and social~     healthcare needs is currently a promising method for informing the organization of healthcare~     supply to these needs.~      Aims: In this prospective cohort study, the investigators aim to assess the Simple Segmenting~     Tool (SST) as a method of patient population segmentation in terms of its inter-rater~     reliability, as well as convergent and predictive validity. We will also revise the tool~     based on feedback from the validity studies should the need arises.~      Hypothesis: The investigators hypothesize that the SST is able to exhibit good inter-rater~     reliability, convergent validity and predictive validity for adverse events.~      Methodology: Non-critical patients aged 55 and above presenting to the Emergency Department~     will be screened with the SST. Raters will be paired in order to assess inter-rater~     reliability. To test convergent validity, the LACE, SF-12, and Clinical Frailty Scale (CFS)~     will also be used. Finally, predictive validity will be assessed by evaluating adverse event~     rates of patients in each SST category. Adverse events include all-cause mortality, length of~     hospital stay, emergency department visit and unplanned hospital readmission.~      Significance to Health Services Delivery: This study will provide evidence supporting the use~     of a standardized tool for evaluating the medical and social needs of patients at various~     sites of care. Following which, tailored packages of healthcare services can then be~     delivered in order to meet these needs.~   "
69059|NCT02663024|"~     This study evaluates the efficacy and safety of three doses of GC1111 in patients with Hunter~     Syndrome. Participants will be randomized to one of three doses of GC1111 or comparator.~   "
69060|NCT02663011|"~     Purpose:~      To assess age and gender effect in the language error type (semantics, syntax and~     pragmatics)of developmental delay preschool aged children, a standardize tool Preschool~     Language Scale Corrected edition(PLS-C), Lin was adopted for evaluation.~      Methods:~      This is a retrospective chart study enrolled 55 children aged 3, 4 and 5 in department of~     rehabilitation in Taipei Medical University Hospital from 2011 Jan to 2014 Dec whose average~     PLS-C score was at least 1.5 SD below normal. Those normal or PLS-C score was less than 1.5SD~     below normal were excluded. We recorded correct percentage in pragmatics, syntax, and~     semantics in different age group separately in auditory comprehension, language expression as~     well as overall performance. All wrong questions answered in PLS-C were recorded. We used SAS~     9.4 (Anova, t-test) to analyze the results in age differences, gender differences, and~     language components differences~      Results:~      In overall performance, expression, and comprehension, there was no difference between boy~     and girl by t-test in all ages. By one-way Anova Bonferroni t test, age 5 was better than age~     4 and age 3 significantly in pragmatics, syntax and semantics (p<0.005).~      We further separated into groups of 5YR boy, 5YR girl, 4YR boy, 4YR girl, and 3YR boy.~      In overall performance, by Duncan's multiple analysis, only 5 YR boy had significant better~     performance than 4 YR girl and 3 YR boy in pragmatics. In age 5, boys had better performance~     in pragmatics than girls (p<0.05). In age 4, no differences are showed between boy and girl.~      In comprehension, in age 5, boys have better performance in pragmatics than girls(p<0.05).~      In expression, there was no difference between boys and girls. Pragmatics was better than~     syntax (p=0.0202<o.o5) in age 5.~      Conclusion:~      We found age had more effect than gender in language delay children. Age 5 boys had better~     performance in pragmatics conflicted with some previous studies and may need more exploration~     in the future.~      Key words:~      Development Delay, Preschool aged children, Language Development Delay, Semantics, Syntax,~     Pragmatics, Language error type~   "
69061|NCT02662998|"~     The aim of this study is to validate uHear™, an iOS-based tool, as a screening tool to detect~     significant hearing impairment as part of a comprehensive geriatric assessment in patients~     aged 70 years and older. The pass or fail screening cut-off is defined as having two or more~     consecutive hearing grades starting from the moderate-severe threshold zone ranging from 0.5~     - 2.0 kHz.~   "
69062|NCT02662985|"~     This study is designed to leverage the sensitivity of ultrasonography available in clinical~     practice setting to better describe the time course of response to secukinumab (150 mg and~     300 mg) on joint synovitis and enthesitis in PsA patients with an inadequate response to~     non-biologic DMARDs. PDUS changes in joint synovitis will be assessed using the global~     Outcome Measures in Rheumatology (OMERACT)-European League against Rheumatism (EULAR)~     synovitis score (GLOESS) and changes in joint enthesitis will be assessed using the OMERACT~     enthesitis score.~   "
69063|NCT02662972|"~     Trigeminal neuralgia is one of the strongest pains known to humans. Some patients do not have~     enough effect with the available pharmaceutical treatments and are offered surgery. There are~     different types of procedures and most of them are complex with a risk for complications. The~     researchers want to start a pilot study on 10 patients with a new surgical technique using~     neuronavigation. The target will be a neural structure (sphenopalatine ganglion) which has an~     important role in facial pain. There have been a few trials trying to block this structure in~     trigeminal neuralgia, but none using this new approach with botulinum toxin. The researchers~     technique requires local anesthesia only (awake patient). The researchers believe that this~     treatment can become a low threshold-treatment for patients who do not have enough effect~     with pharmacological treatment and a better alternative to other complex surgical approaches.~     Using this new neuronavigation system the researchers can reach this neural structure with~     high precision.~   "
69064|NCT02662959|"~     Gastric cancer is the leading cause of cancer death in China. Most patients are unresectable~     or metastatic disease at the time of diagnosis. Systemic therapy was required for the~     patients with advanced stage. Platinum combined with fluoropyrimidines always were considered~     as first line treatment. After failure of initial therapy, single agent of taxanes was used~     as second line treatment. However, there is no relative standard chemotherapeutic regimen in~     the third therapy except oral anti-angiogenesis drug-Apatinib. So this study was designed to~     explore the role of single agent with irinotecan as third line treatment in patients with~     metastatic gastric cancer in China.~   "
69065|NCT02662946|"~     A randomized controlled multicenter trial on the usefulness of intraoperative angiography~     with indocyanine green to assess anastomosis perfusion in patients who undergo laparoscopic~     rectal resection or left colectomy.~   "
69081|NCT02662738|"~     This study is to quantify the effect of a natural fruit extract added to a wheat product on~     the time needed to absorb 50% of the apparent total of available exogenous carbohydrate (RaE~     * Time). In addition the different glucose fluxes will be quantified (RaE, EGP and GCR)~   "
69082|NCT02662725|"~     This is a non-controlled, open label, Phase II Study of ipilimumab combined with a~     Stereotactic Radiosurgery. The study included an induction phase of four IV infusions of~     Ipilimumab at 10 mg/kg every 3 weeks associated with a stereotactic radiosurgery performed 3~     days before 2nd ipilimumab administration. A Maintenance phase included Ipilimumab, IV, 10~     mg/kg once every 12 weeks, starting at week 24, in the absence of PD, unacceptable toxicity~     or withdrawal of consent or disease progression. The primary objective is the overall~     survival. The Secondary objectives include safety, ORR, PFS and peripheral blood absolute~     lymphocyte count (ALC) as a predictive biomarker.~   "
69066|NCT02662933|"~     AML is a disease of older adults, with a median age at diagnosis of 67 years . An estimated~     13,410 new cases of AML will be diagnosed in 2007. Survival for AML is age-dependent, with~     significantly lower survival rates reported for older adults. SEER statistics from 1996-2003~     show a 5 year relative survival rate of 34.4% for adults younger than 65 and 4.3% for those~     ≥65 years of age 1. Clinical trials have demonstrated worse survival outcomes in older adults~     with AML using age cutoffs of 55, 60 and 65 years. Older adults have also experienced~     increased toxicity to standard therapies in clinical trials. Chronologic age cutoffs have~     therefore been used in research and clinical practice due to concerns regarding toxicity~     associated with treatment. The reasons for the increased toxicity and decreased survival in~     older adults with AML is incompletely understood and likely multifactorial including both~     tumor specific and host specific factors. Improving understanding of which measurable~     clinical characteristics predict vulnerability to toxicity will help refine the research and~     clinical approach to older adults with AML.~   "
69067|NCT02662920|"~     Prevalence and prognostic significance of polypharmacy has not been evaluated in adults~     undergoing treatment for AML. Investigating the significance of polypharmacy in this~     population may help improve patient assessment and provide an opportunity to design simple~     interventions to minimize unnecessary morbidity associated with treatment.~   "
69068|NCT02662907|"~     The goal of this clinical research study is to learn if exercising the muscles that help you~     cough and swallow, called expiratory muscle strength training (EMST), can help reduce the~     risk of pneumonia due to aspiration (inhaling saliva instead of swallowing it) in patients~     who have had radiation for head and neck cancer.~   "
69069|NCT02662894|"~     Noninferiority trial to assess efficacy of fixed-dose combination of valsartan + rosuvastatin~     versus their isolated components in treatment of hypertension and dyslipidemia.~   "
69070|NCT02662881|"~     This study will evaluate the performance of biologically assisted core decompression with the~     PerFuse instrument and BioCUE in patients with bone lesions in the femoral head. The study~     will explore the potential impact of patient demographics and baseline characteristics on~     post-operative outcomes.~   "
69071|NCT02662868|"~     The purpose of this study is to describe demographics and socioeconomics characteristics~     associated to the diagnosis of metastatic breast cancer in Brazil.~   "
69072|NCT02662855|"~     The purpose of this study is to explore the therapeutic efficacy of Favipiravir, a~     broad-spectrum antiviral drug against severe cases of Ebola Virus Disease (EVD), which is the~     most difficult aspect for clinical management of EVD due to its high fatality rate.~   "
69073|NCT02662842|"~     Continuous Subcutaneous Insulin Infusion (CSII) via insulin pump therapy has been shown to~     improve quality of life and glucose control in many patients with diabetes opting for this~     treatment modality. Despite significant innovation and advancement in pump technology,~     insulin infusion sets have been an area where innovation has been significantly lacking with~     no clinical studies performed prior to product launches.~      BD has developed a subcutaneous infusion set with FlowSmart™ Technology designed to address~     patient comfort, insulin delivery and flow interruptions. According to preliminary animal and~     clinical studies, this technology results in lower infusion pressure indicating more~     consistent insulin delivery.~      The FlowSmart infusion set has been previously tested in prototype form with healthy~     non-diabetic subjects with the sets inserted by nurses, and with CSII-using patients who~     self-inserted the FlowSmart infusion set in a clinical research setting.~      The purpose of this study is to determine if insulin pump users prefer using the BD FlowSmart~     infusion set compared to their current set with respect to insertion pain and wear comfort.~   "
69074|NCT02662829|"~     Lesotho, a small, landlocked country completely surrounded by South Africa, is among the~     world's poorest nations with one of the world's most severe epidemics of tuberculosis (TB)~     and HIV. TB incidence is the world's highest and approximately 76% of TB patients are HIV~     coinfected. Data from similar settings suggest that TB incidence in children is approximately~     50% of adult TB incidence. The Lesotho National TB Program has adopted World Health~     Organization's (WHO) isoniazid preventive therapy (IPT) recommendations for child contacts;~     however, as in other countries in the region, implementation of IPT in children is limited,~     no clear strategies guide child contact tracing and screening, and no clear methods ensure~     provision of IPT in children. Thus, it is important to evaluate novel methods to prevent TB~     in child contacts of adult TB cases.~      The purpose of the PREVENT Study is to identify an effective and acceptable intervention that~     addresses programmatic, structural and psychosocial barriers to contact tracing, screening,~     and IPT for child contacts of TB patients, with the ultimate goal of improving health~     outcomes among children in Lesotho. The study is a two-arm cluster randomized trial,~     randomized at the TB clinic level, which includes ten TB clinics in Berea district. Clinics~     are randomized to deliver the community-based intervention (CBI) or standard of care (SOC),~     with stratification by facility type. The experimental intervention will be delivered to all~     child contacts of adult TB patients in TB clinics randomly assigned to CBI. In TB clinics~     assigned to SOC, usual care procedures for contact tracing and IPT will be delivered.~   "
69075|NCT02662816|"~     Glutathione (glutamyl-cysteinyl-glycine) is the main intracellular compound. It participates~     also in the detoxification of electrophiles molecules of which paracetamol. It is synthesized~     in the liver during the postprandial phase, which establishes a stock that is mobilized for~     the other tissues (muscle)during the postabsorptive period. It is of common knowledge that~     the decrease in glutathione concentrations associated with ageing could be involved in the~     development of the degenerative pathologies linked to the old age. These changes could be~     reversed by an increase in dietary cysteine, the amino acid limiting of the endogenous~     synthesis of GSH. The development of nutritional strategies aiming at an improvement of the~     status glutathione requires the determination of its concentration within tissues, where it~     is active. The quantification of tissue concentrations of glutathione by biochemical~     techniques requires tissue biopsies. Such a method can be performed for the muscle, but liver~     biopsy is not feasible outside of a surgery. It is necessary to set up a non-invasive method~     to quantify muscle and liver glutathione.~   "
69076|NCT02662803|"~     This study investigate the effect of high-intense aerobe exercise training (HIT) on clinical~     and physiological parameters (anxiety, somatisation, cortisol, alpha amylase, mismatch~     negativity, loudness dependence auditory evoked potentials) in patients with generalized~     anxiety disorder (GAD). Half of patients will receive HIT, while the other half will receive~     aerobe exercise of low intensity.~   "
69085|NCT02662686|"~     The number of copies of mitochondrial genes (mtDNA or MitoScore) is related to the energy~     supply of the embryo, which can affect its ability to implant in the maternal uterus.~      The objective of this study is to analyse the potential of MitoScore before embryo transfer~     as a marker to identify and select the embryo with greater capacity of implantation. First of~     all, chromosomally normal embryos will be selected and mtDNA copies will be quantified.~     Finally, embryos with less copies of mtDNA will be considered for embryo transfer.~   "
69086|NCT02662673|"~     Focal treatment of localized prostate cancer aims to destroy the cancerous foci without~     damaging surrounding tissues to avoid the side effects of radical treatments. This is why~     focal treatment is positioned as an alternative to radical surgery as well as an alternative~     to active surveillance.~      This study is a feasibility study. It aims at treating the index tumor (the most aggressive~     one) which determines the vital prognosis of patient, while preserving the maximum~     surrounding prostatic tissue to preserve quality of life. The expected result is the total~     destruction of aggressive tumor areas by focal or multifocal treatment strategy using the~     Focal One® device (EDAP-TMS, Vaulx-en-Velin, France). The tumor destruction is validated by~     the negative biopsy rate between 6 and 12 months post-treatment.~   "
69087|NCT02662660|"~     A prospective randomized study of patients undergoing laparoscopic sleeve gastrectomy between~     2012 and 2015 will be performed. Patients will be divided into 3 groups: Analgesia iv~     exclusively (Group 1), epidural analgesia+analgesia iv (Group 2) and port-sites~     infiltration+analgesia iv (Group 3). Pain will be quantified by means of a Visual Analogic~     Scale and morphine rescue needs were determined 24 hours after surgery.~   "
69088|NCT02662647|"~     Demethylating agent decitabine enhances the immunogenicity of leukemia cells by inducing the~     expression of cancer testis antigens (CTAs),MHC class I and II molecules,costimulatory~     molecules and adhesion molecules. The leukemias cells treated by decitabine will become more~     sensitive to the following adoptive T cell therapy.We proposed a hypothesis that~     decitabine-based chemotherapy acts in synergestic with haploidentical lymphocyte infusion in~     eliciting leukemia specific cytotoxic lymphocyte(CTL) and diminishing leukemic cells.~   "
69089|NCT02662634|"~     Feasibility and Safety study of autologous dendritic cell immunotherapy (AGS-003-LNG) in~     patients with resectable non-small cell lung cancer.~   "
69090|NCT02662621|"~     Recent studies shows that extracellular vesicles (named exosomes) released by cancer cells~     exhibit at their membrane the stress protein HSP70, contrary to exosomes released by normal~     cells. These exosomes (HSP70-exosomes) have a very important role in intercellular~     communication and have specific biological functions that can promote tumor progression. They~     are found in the different biological fluids such as blood and urine.~      We have developed a protocol able to isolate exosomes in blood and urine. We also~     demonstrated that only exosomes derived from cancer cell have HSP70 at their membrane. Those~     results strongly suggest that we can only identify exosomes with HSP70 at the membrane in~     patients with cancer.~      Detection of HSP70-exosomes in the diagnosis of patients is a promising pathway of research.~     Because a cancer cell can releases a large amount of exosomes (several billion) and since its~     appearance, our approach will allow to earlier detect cancer with respect to the use of~     imaging and circulating tumor cells (CTCs), which remains a rare event (about one CTC of 1~     billion cells).~      The aim of this study is to demonstrate that HSP70-exosomes could be used for early diagnosis~     of patients with malignant solid tumor. In order to demonstrate this, the objective of the~     study is to study blood and urine samples from 60 subjects with a malignant tumor and 20~     healthy subjects (witness).~   "
69091|NCT02662608|"~     The goal of this study is to start treatment with the NOTCH1 inhibitor brontictuzumab in an~     attempt to control tumors and prolong survival. The therapy involves participant being given~     the drug brontictuzumab to treat adenoid cystic carcinoma (ACC) with NOTCH 1 mutations. This~     is considered an investigational treatment.~   "
69092|NCT02662595|"~     The question that this project seeks to answer, is whether mobile phones can be used to~     increase the measles vaccination coverage and timeliness in Guinea-Bissau. The intervention~     will be evaluated in terms of direct health outcomes and cost/benefit analysis, generating~     evidence that could help policy makers making informed decisions about implementing mHealth~     interventions at a national level.~      The intervention takes the form of a randomized controlled trial in which text messages (SMS)~     as well as voice calls are scheduled and delivered to mo thers to remind and encourage them~     to have their children timely vaccinated against measles. In addition, the messages will~     include relevant information about opening hours and availability of the measles vaccine at~     the mothers' local health facilities thus improving coordination. The trial will include~     three different randomization groups with approx. 350 participants in each group. The first~     group will receive SMS messages, the second group will receive a voice call in addition to~     the SMS messages, and the third group is a control group that does not receive any~     intervention.~      Study participants will be enrolled following birth at one of three health centers in~     different rural regions of Guinea-Bissau. Before the measles vaccine is scheduled to be~     given, at 9 months of age, mothers will receive the intervention message depending on their~     assigned randomization group. When the measles vaccine is administered, the child will be~     registered as having received the measles vaccination.~      A follow-up phone interview will be conducted at 12 months of age for all children~     participating regardless of randomization group and whether or not they received the measles~     vaccine. All participating children, who at that time still have not received the measles~     vaccine, will be offered the vaccine at the expense of the project.~   "
69093|NCT02662582|"~     The purpose of this study is to assess the effect of CK-2127107 relative to placebo on cycle~     ergometer exercise tolerance, assessed as change from period baseline in constant work rate~     (CWR) endurance time, utilizing a breath-by-breath metabolic measurement system with~     integrated electrocardiogram (ECG). The time to intolerance is assessed by a stopwatch and~     verified from electronic recordings of the cycle ergometer.~      This study will also assess cardiopulmonary and neuromuscular effects of CK-2127107 relative~     to placebo; the effect of CK-2127107 on resting spirometry relative to placebo; the safety~     and tolerability of CK-2127107 as well as the pharmacokinetics of CK-2127107.~   "
69094|NCT02662569|"~     The primary hypothesis is that both dosing regimens of SC evolocumab (AMG 145) in combination~     with statin therapy will be well tolerated and will result in greater reduction of LDL-C in~     diabetic subjects with hyperlipidemia or mixed dyslipidemia.~   "
69095|NCT02662556|"~     This is a multicenter, open-label study in patients 40 years and older who are undergoing a~     surgical procedure.~      Patients may receive one dose of ST 30 mcg as needed for pain management, but no more~     frequently than every 60 minutes, for up to 12 hours.~   "
69096|NCT02662543|"~     This study is designed to estimate the changes in the etiology and epidemiology of acute~     gastroenteritis in children aged less than 18 years after the implementation of rotavirus~     vaccine in the Estonian national immunization program in July 2014.~   "
69097|NCT02662530|"~     This study investigates the use of a kinematic measurement device to quantify the abnormal~     head movements and postures in patients with cervical dystonia (CD) in order to individualize~     and optimize botulinum toxin type A (BoNT-A) injection therapy. A single sensor captures five~     degrees of freedom of the neck and head that distinguish which muscle(s) contribute to CD and~     the amount of BoNT-A to inject into these muscle(s). The efficacy, relief and improvements in~     social, occupation and function by injections will be investigated. The efficacy of BoNT-A~     therapy using either BoNT-A injection parameters from clinical-based assessments and~     kinematically-based assessments will be investigated in CD patients. Individuals clinically~     diagnosed with CD will be randomized for two treatment conditions: A) injection parameters~     from a kinematic assessment only, or B) injection parameters from a clinical assessment only.~   "
69098|NCT02662517|"~     Human breast milk contains growth factors including neurotrophins and cells with~     neuroprotective potential. Concerning growth factors milk of preterms differs significantly~     from term milk. The aim of this study is to give a profile of human milk concerning~     non-nutritive factors depending on gestational age and lactation phase.~   "
69099|NCT02662504|"~     Malignant pleural mesothelioma (MPM) is an aggressive tumour with poor prognosis (median~     survival <13 months), and high resistance to chemotherapy. Extended pleurectomy/decortication~     (eP/D) is a debulking surgery of MPM but cannot be considered as a curative treatment.~     Therefore it has been suggested that eP/D may be of interest if combined with intra-operative~     treatment and adjuvant therapies.~      Photodynamic Therapy (PDT) is an innovative treatment based on the rationale that tumour~     cells, if previously treated with photosensitizing drugs (Photofrin), will die when exposed~     to light at a particular wavelength. Interestingly PDT might also stimulate anti-tumour~     immune response through the release of tumour antigens and induced inflammation.~      PDT was tested in phase I-II trials for MPM in combination with EPP or eP/D, and~     chemotherapy. US studies from J Friedberg et al found very promising survival results in MPM~     when combining eP/D, but not EPP, intra-operative PDT and chemotherapy~     (cisplatin-pemetrexed), with a median overall survival of 31.7 months.~      However, the definitive value of intra-pleural PDT combined to eP/D in the treatment of MPM~     still need to be validated. The same multimodal treatment has been established in Lille, the~     French national expert centre for MPM, with the help of our american colleagues. Therefore,~     this phase II trial proposes to patients to benefit from the combination of eP/D,~     intra-operative PDT then chemotherapy by cisplatin-pemetrexed and prophylactic radiotherapy.~      Primary endpoint is the feasibility for the patients to have the full multimodal treatment of~     MPM including intrapleural PDT without unacceptable or unexpected grade III-IV toxicities.~     Secondary endpoints are PFS, OS, ORR, and quality of life. If the feasibility of such~     treatment would be confirmed in France, a multicentric, randomized trial comparing this~     experimental treatment vs control arm (same multimodal treatment without PDT) is planned.~   "
69100|NCT02662491|"~     The trial plan to determine whether a daily capsule containing vitamin D(3) (2000 IU),~     calcium (600 mg), both, or a placebo for 6 months in UAE citizens with evidence of vitamin D~     deficiency will lead to a clinical benefit. The proposed study will also determine the~     threshold of vitamin D and calcium intake or levels considered optimal for UAE citizen's~     health~   "
69101|NCT02662478|"~     Despite laparoscopic surgical treatment has not been recommended in patients with gastric~     gastrointestinal stromal tumors (GIST) larger than 5 centimeter, but it continues to evolve~     rapidly to overcome the boundaries. Therefore the authors generated a morpho-anatomical~     classification system (MACS) adapted for primary gastric GISTs, by which they could plan to~     tailor the laparoscopic gastric resection appropriately. The aims of the study was to~     demonstrate the feasibility of laparoscopic surgery for primary gastric GISTs larger than 5~     cm, to find out the accuracy and practicality of the MACS for the development a preoperative~     strategy and the extent to which this strategy overlaps with the reality.~   "
69102|NCT02662465|"~     Before the start of the selected chemotherapy patients will be treated preventively for oral~     mucositis. A group will carry out the mouthwash with chlorhexidine 0.12% twice a day for five~     days and another will be held to damage preventive therapy (wavelength of 660nm, power 100mW~     and lluencia of 4 J / cm² per point, with distance of 2cm between points located on the right~     buccal mucosa, left buccal mucosa, hard palate, upper lip and lower lip). Patients who~     develop oral mucositis even after the prevention, will be divided into three groups for laser~     sessions with the purpose of treatment of oral mucositis. The group assignment obeyed~     severity of oral mucositis. Group 1 will include patients with oral mucositis grade 1. Sera~     used wavelength of 660nm, power 100mW and lluencia of 4 J / cm². Group 2 included patients~     with oral mucositis grade 2. Sera used with a wavelength of 660nm, power 100mW and lluencia~     of 8 J / cm². Group 3 included patients with oral mucositis grade 3 Sera used laser diode~     AsGaAl operating in continuous mode, with a wavelength of 790 nm, power of 100mW and fluency~     of 8 J / cm².~   "
69103|NCT02662452|"~     The purpose of this First-in-Human study is to evaluate the safety and tolerability after~     single ascending oral doses of GLPG2222 given to healthy subjects, compared to placebo (Part~     1). Also, the safety and tolerability of multiple ascending oral doses of GLPG2222 given to~     healthy subjects daily for 14 days compared to placebo, will be evaluated (Part 2).~      Furthermore, during the course of the study after single and multiple oral dose~     administrations, the amount of GLPG2222 present in the blood and urine (pharmacokinetics)~     will be characterized.~      The potential of cytochrome P450 (CYP)3A4 interaction after repeated dosing with GLPG2222~     will be explored as well.~   "
69104|NCT02662439|"~     The aim of this study is to investigate whether the objective measurement of fluid overload~     by bioimpedance analysis (Body Composition Monitor-BCM) in patient with acute decompensated~     heart failure would improve the diuretic therapy.~   "
69105|NCT02662426|"~     Name of study:~      Randomized, Double-Blinded, Oseltamivir-and-Placebo-Controlled Clinical Study about~     Lingdancao Granules in the Treatment of Seasonal Influenza~      Objective:~      Preliminary evaluation on the efficacy and safety of Lingdancao granules in the treatment of~     seasonal influenza~      Design:~      Multicenter, randomized, double-blind, double parallel analogy, positive drug and placebo~     controlled trial~      Case number:~      This test is expected to be included in 318 cases of 14-65 (≥14 or ≤65) ages of subjects.~     Qualified participants are randomly divided into experimental drug group (Lingdancao granules~     group), positive control group (oseltamivir phosphate group) and placebo group, 106 cases in~     each.~   "
69106|NCT02662413|"~     To determine the measurement profiles of the asthma control test (ACT) in an adolescent~     population with persistent asthma.~   "
69170|NCT02661568|"~     This study will utilize a retrospective cohort design. Using the Clinical Practice Research~     Datalink (CPRD) linked with Hospital Episode Statistics (HES) datasets, all patients with a~     record of VTE diagnosis between 1 April, 2008 and 31 March, 2013 will be identified and~     followed from the occurrence of VTE (index date) to the first of 24 months after the index~     date, end of the study period, leaving the database, or death.~   "
69107|NCT02662400|"~     India is the Diabetes Capital of the World with 41 million Indians having diabetes i.e.~     every fifth diabetic in the world is an Indian. Type 2 Diabetes Mellitus (T2DM) constitutes~     the major chunk of diabetes and has insulin resistance as the hallmark feature in the~     pathogenesis. However, with the progression of the disease the insulin resistance becomes~     stable whereas β - cell function shows a gradual decline due to its ongoing apoptosis. This~     ultimately leads to inability of the β - cells to cope up with the increased demand of~     insulin caused due to insulin resistance and manifests as hyperglycemia. As β - cell failure~     is progressive and inexorable, as demonstrated in United Kingdom Prospective Diabetes Study,~     most of the patients with T2DM would eventually require insulin and it would be difficult to~     achieve to attain a strict glycemic control . It is well known that diabetes related~     complications which account for morbidity and mortality in this disease can be prevented or~     delayed by strict glycemic control. However, even with intensive insulin therapy it has been~     shown that glycemic control can never be perfect with patients exhibiting hyperglycemia or~     hypoglycemia during 24 hour glucose profile. Also insulin therapy is not physiological as~     there is no hepatic first - pass metabolism of insulin which is required for halting the~     hepatic glucose output, which is responsible for fasting hyperglycemia. This led the~     researchers to evolve various strategies of β - cell replacement therapy e.g. pancreatic~     transplantation and islet cell transplantation. Initially the results of islet cell~     transplantation were dismal but after the induction of glucocorticoid free immunosuppressive~     therapy and the use of adequate number of islet cells from multiple donors, the results of~     islet cell transplantation have been better. However, islet cell transplantation has its own~     limitations viz insufficient supply, being technically demanding and requirement of lifelong~     immunosuppressive therapy in the recipient.~   "
69108|NCT02662387|"~     Acute respiratory failure secondary to bronchiolitis and asthma is one of the most common~     diagnoses in children admitted to pediatric intensive care unit.~      Objectives: The primary outcome of the study is to compare the respiratory parameters between~     patients on HFNC and HFNC with ENDs.~      Methods: This is a prospective randomized controlled trial. All children admitted to Loma~     Linda University Children's Hospital due to acute respiratory failure secondary to~     bronchiolitis and asthma are eligible for inclusion in the study. Multiple respiratory~     parameters will be collected as part of the study. The investigators anticipate that use of~     END will have a positive impact on the respiratory status of children with acute respiratory~     failure. Appropriate statistical analysis of the data will occur after the data has been~     de-identified.~   "
69109|NCT02662374|"~     Oral mucositis is one of the most common debilitating forms of mucositis that arise from high~     dose chemotherapy and radiotherapy. It is reported that almost 75% patients undergoing~     hematopoietic cell transplantation (HCT) develop oral mucositis at different levels of~     severity. The objective of this prospective study was to assess the efficacy of the addition~     of supersaturated calcium phosphate oral spray and the addition of an extra soft tooth brush~     to the basic OH in addition to the currently existing oral hygiene protocol regimen (0.2%~     Chlorhexidine Gluconate + 3% Sodium Bicarbonate+ Nystatin 100000 U/ml) in reducing the~     severity of oral mucositis among patients receiving chemotherapy for HCT.~      60 patients receiving chemotherapy for HCT were randomly allocated to four groups of 15~     patients each The oral mucositis was recorded according to WHO criteria and the progression~     of the oral mucositis was monitored from the day of admission (day~        -  1) to the day of discharge (day 28). The absolute neutrophil count, platelet counts and~          salivary flow rate of all patients was recorded.~   "
69110|NCT02662361|"~     To investigate the patient-related risk factors for peri-implant disease in partially~     edentulous patients rehabilitated with implants supported crown or bridge so as to provide~     evidence for clinical prevention and control.~   "
69111|NCT02662348|"~     This phase I trial is to investigate the safety and the possible side effects of bi-specific~     antibody armed T-cell therapy when given together with low-dose IL-2 in treating patients~     with Her2-positive neoplasms of digestive system. Expanded autologues T cells that have been~     coated with bi-specific antibodies, such as anti-CD3 and anti-human epidermal growth factor~     receptor 2 (HER2), may stimulate the immune system in different ways and stop tumor cells~     from growing. Interleukin-2 may stimulate white blood cells to kill tumor cells.~   "
69112|NCT02662335|"~     This randomized clinical trial studies computerized cognitive retraining in improving~     cognitive function in breast cancer survivors. Cancer-related cognitive deficits, such as~     thinking and memory issues, are common among breast cancer survivors. The severity of these~     cognitive deficits is associated with a significant negative impact on daily function and~     quality of life. A computerized cognitive retraining method may help researchers find ways to~     improve cognitive function and quality of life in breast cancer survivors.~   "
69113|NCT02662322|"~     The purpose of this study is to compare three communications during peripheral intravenous~     catheterization and measure pain patient: one hypnotic, confusion (HYPNOSIS), an other with~     negative connotation (NOCEBO) and at least with neutral connotation (NEUTRAL).~   "
69114|NCT02662309|"~     ABACUS is an open-label, international, multi-centre, window of opportunity phase II trial~     for patients with histologically confirmed (T2-T4a) transitional cell carcinoma of the~     bladder. The trial aims to test the efficacy of preoperative MPDL3280A and will include~     extensive biomarker work on samples from these patients. Eligible patients will receive two~     3-weekly cycles of MPDL3280A pre-cystectomy. Following cystectomy, patients will be followed~     up for safety, survival, and disease data.~   "
69115|NCT02662296|"~     This phase II trial studies how well ibrutinib or idelalisib works in treating patients with~     chronic lymphocytic leukemia, small lymphocytic lymphoma, or non-Hodgkin lymphoma that is~     persistent or has returned (relapsed) after donor stem cell transplant. Ibrutinib and~     idelalisib may stop the growth of cancer cells by blocking some of the enzymes needed for~     cell growth.~   "
69116|NCT02662283|"~     This prospective, randomized, controlled, multi-center clinical trial will evaluate the~     effect and security of reh-acteoside therapy for patients of IgA nephropathy.~   "
69117|NCT02662270|"~     Fibromyalgia is a relatively young condition recently recognized by the WHO as a separated~     clinical entity. Part of the medical comunity thinks of it as a mixed condition between~     depresion and rheumatic pain, however, functional data provided by sophisticated imaging~     techniques points at a diminished brain activity in several brain regions. The present study~     aims to characterize those findings by means of QEEG in order to establish the~     electroencephalographic characteristics of fibromyalgia patients.~   "
69118|NCT02662257|"~     Surgery is one of the major treatment methods for patients with malignant tumor. And, alone~     with ageing process, more and more elderly patients undergo surgery for malignant tumor.~     Evidence emerges that choice of anesthetics, i.e., either inhalational or intravenous~     anesthetics, may influence the outcome of elderly patients undergoing cancer surgery.~     Delirium is a commonly occurred early postoperative cognitive complication in the elderly,~     and its occurrence is associated with the worsening outcomes. Choice anesthetics may~     influence the occurrence of postoperative delirium. However, evidence in this aspect is~     conflicting.~   "
69119|NCT02662244|"~     Basal cell carcinoma (BCC) is the most common skin cancer worldwide. Although this tumor is~     rarely life threatening, it is locally destructive and can cause significant cosmetic and~     functional problems. Standard therapeutic modalities for BCC often result in disfigurement~     from surgical treatments and recurrences with topical therapies. Thus, there is a need for~     alternative non-surgical options that are effective, efficient, and have a low risk of side~     effects. This has led to the emergence of laser investigations for the treatment of BCC due~     to the ease of treatment, lack of significant downtime, decreased risk of complications, and~     absence of a surgical scar. The primary objective of this study is to evaluate the safety and~     efficacy of laser treatment of subjects with BCC on the trunk and extremities. Subjects will~     receive one treatment with the laser to the BCC. Standard excision will be performed between~     30 and 90 days after laser treatment to evaluate resolution of the BCC. A visit for suture~     removal will be performed as appropriate for the site of the surgery. Standardized~     photographs and measurements will be taken at the baseline visit, immediately after laser~     treatment and on the day of excision.~   "
69120|NCT02662231|"~     Surgical site infection (SSI) is the most common complication following major~     gastrointestinal surgery, affecting between 25-40% of patients. The rate of SSI doubles from~     low-income to high-income settings, persisting after risk adjustment. Investigating the~     diagnosis and treatment of SSIs remains a largely unaddressed global health priority. The~     impact of antibiotic resistant organisms and the effectiveness of antibiotic prophylaxis are~     unknown. This study aims to determine SSI rates following gastrointestinal surgery across~     worldwide hospital settings.~   "
69121|NCT02662218|"~     This prospective, multicenter, single-arm observational study aims to document the clinical~     performance and safety of a sterile, bacteria-binding, super-absorbent wound dressing for the~     intended use in a daily clinical practice. 50 patients (male/female) with superficial wounds~     of any etiology affecting only epidermis and dermis layer, with one or more clinical signs of~     infection or at high risk of infection and also high to very high exudate levels will be~     observed over a period of 14 days.~   "
69122|NCT02662205|"~     Clients of the student counseling center at Oklahoma State University who are interested in~     participating in the study will be randomly assigned to a traditional process group, a yoga~     class, and a yoga therapy group. Outcome of the three conditions will be compared.~   "
69123|NCT02662192|"~     This study examines the effect of an exercise and health education/auditory rehabilitation~     and socialization intervention on functional fitness, hearing handicap and psychosocial~     distress measures in older adults with hearing loss.~   "
69124|NCT02662179|"~     Identifying the frail elderly patients or those at risk of becoming frail has become a~     cornerstone of modern geriatric medicine. Many instruments have been developed to identify~     fragility at the individual level. The 'Fragile' phenotype defined by Fried is based on 5~     criteria: weakness, slowness, low level of activity, exhaustion, and unintentional weight~     loss. The patient is fragile if it meets at least three out of five criteria. It is~     'pre-fragile' if it meets one or two criteria.~      In onco-geriatrics, the International onco-geriatrics society recommends the implementation~     of a 'G8 scale' to detect elderly patients at risk of fragility. People with a positive G8~     are then referred to the geriatric team to benefit from a comprehensive geriatric assessment.~     This evaluation is interpreted by the geriatrician, who proposes an action plan to overcome~     the various problems of the elderly patient. The evaluation can also help the oncologist in~     the choice of treatment for the patient: palliative care, standard treatment or adapted~     treatment (No-go, Go-go or slow-go).~      The investigators would like to assess if fragility as defined by the Fried criteria is~     predictive of a functional, physical or cognitive decline, or a loss of quality of life in~     patients treated for a solid malignant tumor.~      Furthermore, they will assess if the frailness categorization has an impact on the oncologic~     treatment decision. Does the oncologist switches the patient's oncologic treatment after~     being informed of the frailness status ?~   "
69125|NCT02662166|"~     Bladder cancer (BC) as the most common malignancy arising from the urinary tract continues to~     be a major health problem. This prospective non-randomized study will enroll 150 patients~     undergoing magnetic resonance imaging (MRI) at different stages of their diagnostic and~     therapeutical process. The enrolled patients with suspected BC (BC) based on cystoscopy will~     have their initial MRI examination before transurethral resection of bladder tumor (TUR-BT)~     and biomarker collection. After pathology review of the histological specimens, patients will~     be treated according to standard clinical practice. The second MRI examination will be~     performed before therapeutic intervention, if TUR-BT alone is not sufficient enough.~     Neoadjuvant chemotherapy will be applied in high risk patients having muscle invasison, while~     intermediate risk patient - T1 high grade or carcinoma in situ patients - will be treated~     using Bacillus Calmette-Guerin (BCG) instilliations. After the completion of the neoadjuvant~     chemotherapy or BCG treatment, the patients will undergo the third MRI examination. Low risk~     patients will be followed by annual with MRI examination.~   "
69126|NCT02662153|"~     Retrospective study to assess incidence and predictors of opioid abuse, addiction, overdose &~     death among patients prescribed ER/LA opioid products~   "
69127|NCT02662140|"~     The primary purpose of this study is to develop a mobile health (mHealth) application that~     will both advance theory in and clinical practice of homework (HW) implementation. The mobile~     health application will enhance the existing evidence informed curriculum of a Multiple~     Family Group model (called 4 Rs and 2 Ss for Strengthening Families Model) for families with~     children who have disruptive behavior disorders. This mobile application consists of two~     primary components that will support engagement and integration of the model's core concepts~     in family life. The first component focuses on delivering homework via a highly engaging,~     multiplayer, interactive, cooperative, and skill-building game platform aimed at improving~     the Design and Do process of homework.The second component focuses on targeting factors~     putatively related to poor HW implementation within the Do process.~   "
69166|NCT02661620|"~     A Retrospective-Prospective Study of REDAPT Revision Femoral System Modular Stem is a~     post-market, retrospective-prospective, multi-center, single arm, consecutive series study~     design to provide data on the post market performance and safety of the study device. The~     study will collect retrospective data from medical records review and prospective data from~     observations data at 5 and 10 postoperatively clinical visits. There will also be a 7 year~     telephone follow up contact to assess for device status and adverse events.~   "
69128|NCT02662127|"~     Venous disease effects 25% of the population and most healthy people experience venous~     symptoms after standing for too long. The prime function of leg veins is drainage. Failure~     leads to a condition called chronic venous insufficiency (CVI) with leg pain, heaviness,~     swelling, varicose veins, ankle skin changes, eczema and occasionally venous ulcers. The aim~     of the study is to identify blood components (biomarkers) that occur during the damaging~     phase of standing versus the healing phases of lying recovery and with medical compression~     stockings. This will be achieved by taking a blood sample from the ankle region at 3 separate~     visits (days) to the vascular laboratory at Ealing Hospital. The first visit will be after~     supervised standing for 1 hour. The second after supervised lying and the third standing~     whilst wearing a medical compression stocking. Healthy volunteers will be compared to~     patients with advanced CVI.~      The potential importance to patients and the public is threefold. Firstly, biomarker profiles~     will be obtained in each of the 3 states to increase understanding in the cellular mechanisms~     of damage and recovery. In this way bad and good biomarkers can be identified. Secondly,~     drug treatments may develop from this research to adjust biomarkers towards a favourable~     profile. Thirdly, the success of treating CVI with surgery, venous intervention or~     compression can be monitored. Whilst it is known that relief of gravitational stress is the~     treatment for all forms of CVI, the mechanisms of repair and its discrimination from damage~     have yet to be identified.~   "
69129|NCT02662114|"~     This trial is conducted in Europe. The aim of this trial is to investigate the effectiveness~     of Tresiba® (insulin degludec) after switching basal insulin in a population with type 1 or~     type 2 diabetes mellitus.~      EU-TREAT (EUropean TREsiba AudiT)~   "
69130|NCT02662101|"~     Chronic non-healing wounds considerably impact quality of life in affected patients and are a~     substantial burden on the Canadian health care system. Microbes colonizing a chronic wound~     play an important role in impeding effective healing. Chronic wounds are colonized by~     polymicrobial communities and no single organism can be seen as causal. Only a small fraction~     of wound bacteria are cultured by diagnostic tests and studies have shown little agreement~     between culture and molecular based approaches, therefore an effective diagnostic for wound~     microbes is required. It is know that the composition of the microbial community associated~     with a wound changes as it heals although the causal relationship is somewhat unclear.~     Although not very effective in treating chronic non-healing wounds, antibiotics are often~     administered, contributing to concerns of antibiotic resistance. The wound dressings produced~     by Exciton Technologies Inc. (ETI) effectively aid in the healing process in chronic wounds~     through unknown mechanisms. ETI's wound dressings contain a combination of silver salts with~     three different valence, +1, +2 and +3 that have antimicrobial activity and are effective in~     reducing biofilm formation in vitro. However, it is not known how these silver salts impact~     microbial ecology of the wound and the role this plays in wound healing. The objectives of~     this research are to develop a new diagnostic tool based on molecular characterization of~     wound sites so as to predict how to best treat wounds and to identify new microbes to be~     targeted by ETI's technology. This project will utilize molecular microbial ecology for the~     assessment and evaluation of topical silver interventions, gaining insight into the~     management of chronic infection. Substantiating the microbiota-modifying effectiveness of~     silver wound dressings towards increasing clinician and patient understanding to improving~     clinical outcomes.~   "
69131|NCT02662088|"~     The purpose of this study is to collect a multi-institutional database including all relevant~     data regarding the surgical and clinical features of patients underwent to laparoscopic~     lavage for complicated colic diverticulitis. The main objectives are:~        -  To determine the surgical and clinical outcomes, in the short and long term.~        -  To compare results according to the different type of techniques, device used and manner~          of execution of the different surgical steps.~        -  To relate results of different surgeries with baseline characteristics of patients and~          stage of disease.~   "
69132|NCT02662075|"~     The primary purpose of this study is to evaluate the acute effects of electronic cigarette~     (e-cigarette) smoking on measurable biomarkers of platelet function, vascular endothelial~     function and inflammation in healthy active smokers. 10 healthy subjects, smokers, with no~     other medical conditions will be included in this study and measurements will be obtained at~     baseline and after smoking an e-cigarette. The study will contribute to the understanding of~     the effects of e-cigarettes on cardiovascular physiology, specifically establishing if the~     use of e-cigarettes increases platelet aggregation and platelet activation when compared to~     baseline in healthy active smokers, if the use of e-cigarettes decreases brachial artery~     flow-mediated dilation compared to baseline in healthy active smokers, and to determine the~     association between biomarkers of inflammation, platelet function, and vascular endothelial~     function before and after use of e-cigarettes.~   "
69133|NCT02662062|"~     This study will enrol patients with maximally resected (via transurethral resection (TURBT)~     non-metastatic muscle invasive bladder cancer, who either wish to attempt bladder~     preservation therapy or are ineligible for cystectomy. Patients must have adequate organ~     function and performance status to receive cisplatin based chemoradiotherapy, and no~     contraindications to the use of pembrolizumab. The study will enrol 30 patients to be treated~     with pembrolizumab and radiotherapy.~      All patients will be planned to be treated with 64Gy of radiation therapy in 32 fractions~     over 6 weeks and 2 days. All patients will receive cisplatin 35mg/m2 IV concurrently weekly~     with radiation therapy for 6 doses total. Pembrolizumab will commence concurrently with~     radiation and be given 200mg IV every 21 days, continuing until the 12 week cystoscopy and~     assessment.~      Surveillance cystoscopy will be performed 12 weeks after the commencement of~     chemoradiotherapy, and assess the rate of complete response to therapy. A safety follow up~     visit will occur 4 and 12 weeks post cystoscopy. From week 31 survival follow up will~     commence with clinical assessment, cystoscopy and CT staging performed at intervals until 5~     years.~      The objective of the study is to assess the safety and feasibility of combining pembrolizumab~     with chemoradiotherapy. The primary endpoint assessed will be safety, as defined by a~     satisfactorily low rate of unacceptable toxicity (G3-4 adverse events or failure of~     completion of planned chemotherapy and radiotherapy according to defined parameters). The~     secondary endpoint will be efficacy, as assessed by complete response rate of the primary~     tumour at first post chemoradiotherapy cystoscopic assessment. Exploratory analysis will~     include assessment of tumour histopathological, molecular, genetic and immunological~     parameters.~      It is expected that it will take two years to accrue the required 30 patients.~   "
69134|NCT02662036|"~     This study will evaluate the efficacy of analgesia provided by liposomal bupivacaine~     (Exparel) when compared to bupivacaine HCL as a transverse abdominis plane (TAP) block in~     terms of discharge milestones, opioid use, costs, and patient-reported satisfaction at 12,~     24, and 72 hours. The investigators propose that Exparel will lower opioid use, length of~     stay, and overall cost of abdominally-based autologous breast reconstruction, and will lead~     to greater patient satisfaction.~   "
69167|NCT02661607|"~     A prospective study to compare the use of point of care echocardiography versus routine chest~     radiography for the assessment of central venous catheter placement.~   "
69168|NCT02661594|"~     Randomised, single-dose, crossover, placebo-controlled study to see if intravenous~     amisulpride has any effect on the heart rhythm, in particular the QT interval, in healthy~     adult volunteers.~   "
69743|NCT02654080|"~     The purpose of this study is to evaluate the safety and tolerability of an HIV-1 nef/tat/vif,~     env pDNA vaccine delivered with electroporation (EP), followed by a recombinant vesicular~     stomatitis virus (rVSV) HIV envC vaccine boost, in healthy, HIV-uninfected adults.~   "
69135|NCT02662023|"~     Single-injection transversus abdominis plane (TAP) blocks have been used to treat~     postoperative pain, and are become very popular within the United States because of their~     high analgesic potency and relative ease of placement. Unfortunately, the longest local~     anesthetic available lasts only 8-12 hours. Continuous TAP blocks—also termed perineural~     infusion—involve bathing the multiple nerves of the abdominal wall in local anesthetic using~     a percutaneously-inserted perineural catheter inserted just anterior (ventral) and cephalad~     to the anterior superior iliac spine. For most catheter locations, an infusion is preferred~     to a single-injection nerve block because the duration of analgesia may be extended to better~     match the duration of surgical pain. But, unlike brachial plexus, femoral, and sciatic nerve~     perineural infusion, a continuous basal infusion of local anesthetic does not provide~     adequate analgesia for TAP catheters. This may be due to the fact that the TAP is a~     relatively tight space, so it might require a bolus of fluid to adequately spread the~     perineural local anesthetic to the multiple required nerves (as evidence of this,~     single-injection TAP blocks are very effective, although with a limited duration). The result~     is that while single-injection TAP blocks are widely used, TAP catheters have not been~     adopted. This scenario leaves surgical pain untreated following the resolution of the~     single-injection TAP block. The recent development of an infusion pump that can automatically~     deliver repeated bolus doses may allow the spread of local anesthetic to the multiple sensory~     nerves necessary to provide adequate analgesia, with a duration that better matches~     postoperative requirements. The investigators therefore propose a randomized, double-masked,~     controlled trial to determine if delivering local anesthetic as a repeated bolus dose results~     in improved local anesthetic spread/effects compared with a continuous basal infusion for TAP~     catheters.~   "
69136|NCT02662010|"~     The overall purpose of this COMIRB application is to perform a cross-sectional pilot study to~     aid in the design of a prospective epidemiologic study for an NIH grant application. The long~     term goal of this research is to determine if AGEs are predictors of glycemic control and the~     development of diabetic retinopathy in patients with T2DM. Understanding these relationships~     could lead to a prospective prediction of the onset/worsening of diabetic retinopathy in T2DM~     patients and in pre-diabetic individuals.~   "
69137|NCT02661997|"~     The primary aim of this study is to examine the beneficial effects of two novel treatments~     for Gulf War Veteran's Illness (Tai Chi and Wellness intervention) and to establish the~     efficacy of these mind-body approaches to symptom reduction.~   "
69138|NCT02661984|"~     FeNO measurements provide the physician with means of evaluating an asthma patient's response~     to anti-inflammatory therapy, as an adjunct to the established clinical and laboratory~     assessments in asthma. Interpretation of FeNO profiles is based on the nitric oxide plateau.~     To achieve plateau, the duration of exhalation must be sufficient (at least 4 seconds for~     children <12 years and > 6 seconds for children > 12 years (ATS/ERS, 2005).~      Measurement of FeNO using the 6-sec mode may provide a viable alternative in children as~     young as age 4 years who may have difficulty maintaining exhalation for a full 10 seconds.~   "
69139|NCT02661971|"~     Previous studies provide a strong theoretical rationale for the conduct of a randomized study~     evaluating the efficacy and safety of ramucirumab in combination with FLOT in the~     perioperative treatment of resectable adenocarcinoma of the stomach or GEJ.~   "
69140|NCT02661958|"~     The purpose of this study is to evaluate the superiority in efficacy and assess safety and~     tolerability of the products S6G5T-3 and S6G5T-1 as compared to their respective active~     components or the vehicle for the treatment of acne.~   "
69141|NCT02661945|"~     Near-focus with narrow-band imaging is a novel technique to improve the quality of images of~     the irregular mucosal structures and microvessels of gastric neoplasms. The investigators~     compare this technique with indio carmin spray, commonly used tool to determine tumor margin.~     The subject are patients who underwent endoscopic submucosal dissection for gastric~     neoplasms. Participants are randomized into near-focus with narrow-band imaging and indigo~     carmin groups. First, marking is performed at the tumor margins determined by each modality.~     The distance from the marking dots to the tumor margin is measured histopathologically in the~     resected specimens. Finally, the investigators will compare the accuracy between two groups~     based on the distance from marking dots to tumor margin measured by histopathologic~     examination.~   "
69142|NCT02661932|"~     The purpose of this study is to evaluate efficiency and safety of controlled ovarian~     stimulation (COS) associated with an aromatase inhibitor (letrozole) for fertility~     preservation in breast cancer patients.~   "
69143|NCT02661919|"~     Sudden unexpected death in epilepsy (SUDEP) is the most important epilepsy-related mode of~     death. The exact mechanism of SUDEP is not known. It is thought that cardiac and respiratory~     factors are involved. Several ways of preventing SUDEP have been identified. These include~     seizure control, stress reduction, physical activity, family's ability to perform CPR, and~     night supervision.~      A mattress alarm system that monitors nocturnal seizures can alert family members of night~     time seizure activity. Thus, a family member could provide aid and therefore potentially~     avoid SUDEP. The Emfit monitor is intended to perform these tasks.~      Investigators tested the Emfit mattress monitor DVM-GPRS-V2 in combination with the Emfit bed~     sensor L-4060SL in the epilepsy monitoring unit and were able to demonstrate that the device~     has a high predictive value for detection of generalized convulsions and that it can notify~     caregivers in the early stages of convulsive activity.~      This study will further investigate the upgraded (connected to a cloud server via an~     integrated cellular GPRS module) Emfit mattress monitor DVM-GPRS-V2 and the upgraded Emfit~     mattress sensor L-4060SLC in combination with an acoustic and new cloud-based notification~     system.~   "
69144|NCT02661906|"~     The purpose of this study is to determine whether Sudarshan Kriya Yoga intervention has~     effect on the quality of life , anxiety and depression of Type 2 Diabetic Patients.~   "
69145|NCT02661893|"~     The purpose of this study is to assess the effect of single- and multiple-dose of rifampin on~     the single-dose pharmacokinetics of JNJ-42847922 after oral administration to healthy male~     and female participants.~   "
69146|NCT02661880|"~     Current practice in larger palliative care centers offer many supportive service modalities,~     which are often unavailable in the rural setting. Music Therapy by experienced registered~     Music Therapists is an example of such a modality. The current evidence continues to grow,~     identifying Music Therapy's benefits to help with symptom relief as well as to improve~     Quality of Life in many aspects of medicine, but especially in the context of palliative~     care. This proposal outlines an initiative to provide music-based interventions in a rural~     community palliative care unit where there is limited availability to a registered Music~     Therapist.~   "
69147|NCT02661867|"~     Objective of this longitudinal observational cohort study was to analyze incidence of pelvic~     floor dysfunction (PFD) symptoms, including pelvic organ prolapse (POP), urinary incontinence~     (UI), and fecal incontinence (FI), seven to twelve years after delivery, in two groups of~     singleton primiparae after vaginal delivery (VD) and cesarean section (CS).~   "
69744|NCT02654067|"~     Pregnant patients mallampati class scores will be examined throughout pregnancy~   "
69153|NCT02661789|"~     The project aimed at identifying neuropsychobiological signatures of pharmacological~     sex-steroid hormone manipulations in healthy women as a risk model for depression.~      The study is a double-blind, randomized, placebo-controlled study. Investigators included 63~     healthy female volunteers with regular menstrual cycles between 23 and 35 days. Participants~     were randomized to active Gonadotrophin-Releasing-Hormone agonist (GnRHa) (goserelin 3.6 mg~     implant) or placebo (saline injection) intervention, which was initiated in the mid~     follicular phase (i.e. cycle day 22.6 ±2.5). Sixty women completed follow-up and entered the~     analyses, except for a few drop outs on some domains. The following domains were addressed at~     baseline and at follow-up (16±3 days post intervention), (which corresponded to the early~     ovarian suppression phase of the biphasic hormone response to GnRHa): 1) serotonin~     transporter binding as imaged by 11CDASB Positron Emission Tomography (PET), 2) functional~     Magnetic Resonance Imaging (fMRI) emotional processing, 3) fMRI reward processing, 3) rating~     state fMRI (rsfMRI), 4) structural MRI, 5) Neuropsychology, 6) Psychophysiology, 7)~     Hypothalamus-Pituitary-Adrenal cortex (HPA)-axis dynamics, 8) Peripheral markers of~     immunoactive cell responses, 9) Epigenetic factors.~      Psychometrics in terms of self reported mental distress and interview based ratings were~     monitored across the intervention period to monitor potential symptoms of mental distress and~     psychopathology. Also ovarian hormone responses, peripheral blood markers, and side effects~     scores were collected across the intervention period.~   "
69154|NCT02661776|"~     Cellular immunity can be changed after surgery and anesthesia. Tissue injury by surgical~     procedures significantly reduces the immune function in proportion to the degree of tissue~     injury. In addition, the use of opioids as analgesics during the perioperative period depress~     cellular immunity, in particular the activity of the natural killer (NK) cells. This~     perioperative immunosuppression may cause deleterious consequences on postoperative outcome~     in cancer patients. The aim of this study is to confirm the presence or extent of the change~     of NK cell activity between before and after head and neck surgery. Additionally,~     investigators will identify the clinical or genetic factors related to the change of NK cell~     activity.~   "
69155|NCT02661763|"~     This study will determine the prevalence of rheumatic heart disease (RHD) in Lusaka, Zambia~     through school-based screening methodology using ultraportable echocardiography and a~     recently validated, abridged screening protocol based on World Heart Federation criteria.~     Children that screen positive for RHD at schools will undergo confirmatory evaluation at~     University Teaching Hospital (UTH), Lusaka's main referral hospital.~   "
69156|NCT02661750|"~     The purpose of this study is to document the safety and effectiveness of high doses of~     liquids to clean the colon for colonoscopy in patients who had a previous colonoscopy with a~     poorly cleaned colon.~   "
69157|NCT02661737|"~     To evaluate long-term safety of YVOIRE volumes by incidence of adverse events including~     injection site local reactions and biodegradability.~   "
69158|NCT02661724|"~     Persons with burn-related pain remain under treated and do not have access to comprehensive~     burn pain management. We seek to extend evidence-based cognitive behavioral pain management~     strategies to a group of burn survivors that are currently under treated for for burn pain~     with a specific goal of reducing pain related interference in life activities.~      Investigators will conduct a randomized controlled trial to test the central hypothesis that~     a computer-based cognitive-behavioral program (Take Charge of Burn Pain) will improve pain~     management, psychological health, and improve participation in burn survivors. Specific aims~     include: 1) to determine the efficacy of a web-based self-management intervention in reducing~     pain and pain-related interference and increasing pain management self-efficacy; and 2) to~     determine whether Take Charge of Burn Pain improves psychological health and participation in~     life activities in persons with burn injury pain. Emerging research suggests that web-based~     pain management interventions may be a feasible and effective alternative to clinic-based~     interventions for patients with mobility and geographic restrictions, such as those treated~     at tertiary burn centers.~   "
69159|NCT02661711|"~     The purpose of this study is to assess the safety and efficacy of intravitreal injections of~     Aflibercept (Eylea) in treating Cystoid Macula Oedema (CMO) in patients with underlying~     Retinitis Pigmentosa (RP).~   "
69160|NCT02661698|"~     This study will evaluate the absorption of two different dietary supplements containing the~     omega 3 fatty acids eicosapentaenoic acid and docosahexaenoic acid over 24 hours via venous~     blood plasma following a single dose taken at bed time. In addition, the circadian rhythm of~     fatty acid metabolism will also be assessed following the placebo intervention.~   "
69161|NCT02661685|"~     The purpose of this study is to determine the safety of adoptive transferring autologous~     IKDC-like cells~   "
69162|NCT02661672|"~     Objective: The primary objective of this multicenter prospective registry is to provide~     additional safety, technical outcomes and clinical outcomes data for minimally invasive~     endoscopic surgery (MIES) with Apollo for the evacuation of supratentorial brain hemorrhage~     in adult patients who do not qualify for the concurrent INVEST randomized controlled trial at~     active INVEST centers.~   "
69163|NCT02661659|"~     A phase Ib study investigating the safety, the immunogenicity and the optimal administration~     frequency of the S-588210 5-peptide vaccine in MPM patients without progression after~     pemetrexed-based chemotherapy will be conducted. Additionally, to identify more accurate~     predictive biomarkers of response to S-588210, T-cell-receptor-sequencing (TCR) pre- and~     post-vaccination will be performed in blood samples of patients treated with the vaccine.~     Immunohistochemical analysis of the vaccine oncoantigens will also be correlated with~     induction of antigen-specific T-cell responses. Finally, to explore the infiltration of~     tumors with T-cells and the potential presence of an immunosuppressive tumor~     microenvironment, immunohistochemistry for immune checkpoints (including PDL1/PD1, CTLA4) and~     immune suppressive cell subsets (T-regs, macrophages) will be performed.~   "
69164|NCT02661646|"~     Assessment of QOL and symptoms changes in primary or secondary, unilateral or bilateral lower~     extremity patients using an advanced pneumatic compression system.~   "
69165|NCT02661633|"~     This study is designed to collect data which will be used to correlate changes in EEG to mild~     TBI in sports concussion.~   "
69745|NCT02654054|"~     This study seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in~     combination with estradiol/norethindrone acetate for the management of heavy menstrual~     bleeding associated with uterine fibroids in premenopausal women.~   "
69171|NCT02661555|"~     The purpose of the project is to investigate how aerobic exercise affects brain volume,~     specific brain regions, neurotrophins and cognition in patients with multiple sclerosis.~      The study will be a single blinded randomized controlled trial with a 6 months intervention.~      It is hypothesized that aerobic exercise can slow down brain atrophy, increase the size of~     hippocampus, upregulate the secretion of neurotrophins and improve cognitive performance in~     people with multiple sclerosis.~   "
69172|NCT02661542|"~     A Phase 1/2a, dose-escalation study of FF-10502-01 in Patients with Advanced Solid Tumors and~     Lymphomas. A total of up to 9 cohorts will be enrolled in Phase 1 to establish the MTD. Phase~     2 will consist of 2 cohorts: Cohort 1 will include subjects with Pancreatic Cancer. Cohort 2~     will include subjects with another tumor type enrolled in the Phase 1 dose-escalation phase~     who have demonstrated Clinical Benefit by Week 16.~   "
69173|NCT02661529|"~     The study aims to answer whether the use of a mixture of blood and saline alone (limited air)~     provides the same degree of right-heart contrast enhancement as compared to the standard~     agitated saline (with air), during two types of echocardiograms.~   "
69174|NCT02661516|"~     The purpose of the study is to estimate the impact of bleeding events in patients in the UK~     with non-valvular atrial fibrillation (NVAF) treated with vitamin K antagonists (VKA).~   "
69175|NCT02661503|"~     Primary objective of the trial is to demonstrate non-inferior efficacy of six cycles of~     BrECADD compared to six cycles of escalated BEACOPP, each followed by radiotherapy to~     PET-positive residual lesions ≥2.5 cm, in terms of progression free survival (efficacy~     objective).~      If non-inferior efficacy can be shown, the co-primary objective is to further demonstrate~     reduced toxicity of the BrECADD treatment compared to the escalated BEACOPP treatment~     measured by treatment related morbidity (TRMorbidity objective).~   "
69176|NCT02661490|"~     The purpose of this study is to further develop a formulation and dose regimen of the~     norovirus GI.1/GII.4 bivalent virus-like particle (VLP) vaccine that is immunogenic and safe~     in an elderly population aged 60 years and above.~   "
69177|NCT02661477|"~     The study will investigate the efficacy and safety of subcutaneous interferon alpha -2a to~     eradicate rhinovirus in patients with primary hypogammaglobulinemia. Patients with~     hypogammaglobulinemia have persistent rhinovirus infections. Rhinovirus may worsen pulmonary~     complications. Pegylated interferon alpha with ribavirin appear to effectively clear~     persistent rhinovirus infections in hypogammaglobulinemia patients.~      Patients with primary hypogammaglobulinemia and confirmed respiratory rhinovirus infection~     will be randomly assigned in a double-blind fashion to receive either~        -  Group 1: subcutaneous pIFNα2a~        -  Group 2: subcutaneous placebo Subjects will have scheduled study visits at 1-week and at~          2-month after entry to study. In addition, possible bacterial infections will be treated~          with antibiotics. Each patient will be followed with weekly nasal surveillance samples~          for 2 months and a symptom diary. Blood draws take place at study entry, 1-week and~          2-month time-points.~   "
69178|NCT02661464|"~     The purpose of the study is to assess the long-term safety profile of Ad26.ZEBOV and~     MVA-BN-Filo in participants previously exposed to these vaccines in Phase 1, 2, or 3 clinical~     studies.~   "
69179|NCT02661451|"~     The objective of this study is to determine the safety and efficacy of transcatheter aortic~     valve replacement (TAVR) via a transfemoral approach in HF patients with moderate AS as~     compared with OHFT.~   "
69180|NCT02661438|"~     The rationale of this study is to conduct a summative (i.e., validation) usability test of~     Ciprofloxacin Dry Powder for Inhalation (DPI) and the associated Instructions for Use.~   "
69181|NCT02661425|"~     This is a retrospective study designed to gather outcomes data from existing medical charts~     from patients who have taken EnteraGam for management of their IBS-D for at least eight~     weeks. Data from two study periods will be collected: (1) the time during which the Standard~     of Care (SOC) therapy (i.e., prescribed or over-the-counter as well as FDA-approved or~     non-approved agents) that is used immediately prior to prescribing EnteraGam; and (2) the~     time during which EnteraGam is used as therapy.~   "
69182|NCT02661412|"~     Since its introduction in the late 1990s, immediate implant loading concepts (IL) have become~     a frequent alternative for delayed implant procedures. IL concepts reduce chair time, the~     number of surgical interventions and pain, and offer instant comfort to the patient. Its~     reduced treatment time results in obvious socioeconomic advantages. Although there is at~     present abundant evidence that supports IL, evaluation of long-term biological and mechanical~     stability outcomes of large patient populations could allow quality improvement and more~     accurate patient selection. The Departments of Oral and Maxillofacial Surgery and the~     Department of Dentistry of the General Hospital Saint-John Bruges act as one of the pioneers~     of IL in Belgium, routinely performing the concept since 2001.~      The investigators aim to evaluate the biological and mechanical short- and long-term outcome~     of IL in partially or completely edentulous patients. Moreover, the investigators aim to~     detect potential influencing risk factors predicting undesirable prosthetic outcome.~   "
69183|NCT02661399|"~     The investigators are doing a research study that will teach us about the tingly pain that~     people develop when they get chemotherapy.~   "
69184|NCT02661386|"~     1. An intact pharyngoesophageal reflex is essential to protect the upper airway from~          aspiration of either mouth contents or regurgitated gastric refluxate. This reflex is~          essential at protecting the airway in all patients.~        2. In patients, while under general anesthesia, it is postulated that an identifiable upper~          esophageal sphincter and esophageal peristalsis are not present.~        3. With the cessation of general anesthetics, accompanied by the reversal of nerve block,~          normal pharyngoesophageal peristaltic activity correlates with awakening the patient~          from anesthesia. This would be identified by the performance of esophageal manometry.~        4. A return of normal verbally stimulated pharyngoesophageal swallowing sequence accurately~          identifies a safe time to remove endotracheal tubes and/or reverse anesthesia. This~          verbally stimulated swallowing sequence correlated precisely with the return of~          objective pharyngoesophageal function.~   "
69206|NCT02661100|"~     This study will look at the safety of the combination of three drugs (CDX-1401, Poly-ICL, and~     Pembrolizumab) and its effect on decreasing tumors. Pembrolizumab is an experimental cancer~     drug. CDX-1401 is a tumor specific antigen and Poly-ICL is a Toll-like receptor agonist tumor~     specific antigens which when combined with Pembrolizumab may increase the tumor response to~     this drug.~   "
69185|NCT02661373|"~     Malaria is an infectious disease caused by a parasite that is passed to humans when an~     infected mosquito bites a person. About 3.4 billion people live in areas of the world where~     malaria is regularly found. In many countries, malaria is one of the leading causes of~     illness and death. Despite this, there are a limited number of drugs, called antimalarials,~     that can be used to treat malaria and increasing reports of resistance to existing~     antimalarials.~      The purpose of this research study is to test a new experimental antimalarial drug called~     SJ733 to first assess its safety, tolerability and blood levels in healthy adult volunteers.~      Single-dose, multi-dose and boosted-dose cohorts (both single and multi-dose) will be~     studied. The pharmacoenhancer (booster), cobicistat, will be given in combination with SJ733~     in the boosted dose-cohorts.~      PRIMARY OBJECTIVES:~        -  To assess the preliminary safety and tolerability of escalating doses of antimalarial~          SJ733 in healthy human volunteers.~        -  To investigate the pharmacokinetic (PK) profile of escalating doses of antimalarial~          SJ733 and its metabolite in healthy human volunteers.~        -  To identify a dose of SJ733 that can be tested in a separate Phase 1b human malaria~          challenge study.~        -  To assess the preliminary safety and tolerability of SJ733 in healthy adult volunteers~          after multiple oral dosing.~        -  To assess the pharmacokinetics of SJ733 and its metabolite SJ506 after multiple dosing~          of SJ733 in healthy adult volunteers.~        -  To assess the preliminary safety and tolerability of escalating single oral doses of~          SJ733 in combination with cobicistat among healthy adult volunteers.~        -  To assess the pharmacokinetics of SJ733 and its metabolite SJ506 after single oral doses~          of SJ733 in combination with cobicistat among healthy adult volunteers.~        -  To assess the preliminary safety and tolerability of SJ733 in combination with~          cobicistat in healthy adult volunteers after multiple oral dosing.~        -  To assess the pharmacokinetics of SJ733 and its metabolite SJ506 after multiple dosing~          of SJ733 in combination with cobicistat among healthy volunteers.~      SECONDARY OBJECTIVE:~        -  To assess the impact of food intake on the pharmacokinetic profile of antimalarial~          SJ733.~   "
69186|NCT02661360|"~     The purpose of this randomized, within-subject, cross-over study is to examine if swaddling~     affects bottle feeding performance in infants born preterm. Results from research will have~     implication on neurobehavioral and physiologic outcomes as important indicators for the~     possible effect of swaddling during bottle feeding.~   "
69187|NCT02661347|"~     The purpose of this study is to test the efficacy of transcranial direct current stimulation~     (tDCS) for the treatment of auditory hallucinations in patients currently on risperidone~     treatment who are experiencing recent onset psychosis.~   "
69188|NCT02661334|"~     The purpose of this study is to compare the physical fitness performance—as measured by the~     Air Force Physical Fitness Test (PFT)—of subjects that, in conjunction with exercise, will~     take creatine supplementation over a four week period versus those that do not.~   "
69189|NCT02661321|"~     This was an observational pilot study to examine the usefulness of an electronic sensor that~     monitors short-acting beta-agonist inhaled medication use. The goals of this study were to:~     1) test the feasibility of using the inhaler sensor to measure worsening symptoms and~     exacerbations, 2) characterize physical activity in patients with COPD, and 3) examine~     whether environmental factors can be linked to mild exacerbations measured by the inhaler~     sensor.~   "
69190|NCT02661308|"~     The main purpose of this interdisciplinary proposal is to conduct two randomized controlled~     trial (RCT) of the efficacy of self-administered systematic light exposure (Bright White~     Light (BWL)), an innovative, low cost, and low burden intervention to treat cancer-related~     fatigue. Another common and often overlapping treatment side-effect is cognitive impairment.~     A secondary outcome of the proposed RCT is, thus, cognitive functioning. Finally, possible~     underlying chronobiological (circadian activity rhythms, sleep), biological (pro inflammatory~     markers), and neurophysiological (brain morphology) mechanisms of BWL will be explored.~   "
69191|NCT02661295|"~     The risk of cardiovascular mortality in patients with end stage renal disease on hemodialysis~     is 10-100 times higher than the normal population. This is due in part to high levels of~     inflammation and vascular calcification found in these patients. Phosphate binders,~     particularly non-calcium based phosphate binders, may decrease cardiovascular risk by~     decreasing inflammation and vascular calcification. Ferric citrate a non-calcium based~     phosphate binder with approximately 210 mg of ferric iron has recently been approved for~     patients on hemodialysis. The effect of this phosphate binder on inflammation and lipid~     levels is unknown but investigators hypothesize that ferric citrate has the potential to~     improve inflammation and lipid levels in patients on hemodialysis by decreasing intravenous~     iron requirements and by improving lipid metabolism.~   "
69192|NCT02661282|"~     The goal of Phase I of this clinical research study is to find the highest tolerable dose of~     cytomegalovirus cytotoxic T lymphocytes (CMV CTLs) that can be given in combination with~     temozolomide to patients with glioblastoma.~      The goal of Phase II of this study is to learn if CMV CTLs combined with temozolomide can~     help to control glioblastoma. The safety of this combination will also be studied.~      This is an investigational study. CMV CTLs are not FDA approved or commercially available.~     They are currently being used for research purposes only. Temozolomide is FDA approved and~     commercially available for the treatment of some brain tumors, including glioblastoma. The~     use of this combination to treat glioblastoma is investigational. The study doctor can~     explain how the study drug/cells are designed to work.~      Up to 54 participants will be enrolled in this study. All will take part at MD Anderson.~   "
69193|NCT02661269|"~     Can videomicroscopy of the sublingual microcirculation detect the increase in edema before~     peripheral edema will appear? By measuring the decrease in vesseldensity after strong~     positive fluid balances within septic patients versus euvolemic post-cardiac surgery~     patients. Measuring reactance and resistance (BIVA method) to determine volume status.~      Primary outcome:~      - Total vessel density (TVD)~      Secondary outcome:~        -  Fluid balance~        -  BIVA measurements (reactance & resistance)~   "
69194|NCT02661256|"~     Oral feeding of neonates while on nasal continuous positive airway pressure (NCPAP) is a~     common practice in many neonatal intensive care units (NICU) all over the country. However~     the safety of such practice has never been established. The Investigators hypothesize that~     mechanoreceptors, which should perceive sensory input from the liquid bolus, may be altered~     by the reception of pressurized airflow provided by the NCPAP, hence increase risk of~     aspiration. In this study, changes in the pharyngeal phase of swallowing were identified~     using video fluoroscopic swallow studies (VFSS) for infants while on NCPAP as compared to off~     NCPAP.~   "
69195|NCT02661243|"~     Until now it has not been investigated whether placement of implants in SS patients is less~     successful than compared to non-SS patients. The risk factors and the efficacy of dental~     implants in dry mouth patients are not known because of the lack of scientific evidence. The~     aim of this study is to investigate changes in marginal peri-implant bone loss and the~     clinical performance of dental implants in SS patients compared to implants in healthy~     patients.~   "
69218|NCT02660944|"~     This study evaluates the impact of 13 bi-weekly intravenous infusions of RSLV-132 on the~     cutaneous manifestations in subjects with systemic lupus erythematosus.~   "
69248|NCT02660554|"~     The purpose of this study is to conduct a randomized clinical trial to compare an antibiotic~     strategy based on a novel diagnostic test, polymerase chain reaction (PCR) to usual care, in~     critically ill adults with pneumonia suspected to be caused by methicillin resistant~     staphylococcus aureus (MRSA). The investigators hypothesize that when automated PCR is used~     to guide antibiotic therapy, antibiotic exposure will be reduced in critically ill subjects~     with pneumonia.~   "
69196|NCT02661230|"~     This project proposes the development and design of a motor intervention using a cognitive~     video game and describes the feasibility, safety and acceptability of virtual augmented video~     gaming device named Virtual Reality on the Intensive Care Unit (VRICU). The project in two~     phases is performed in healthy participants (Phase 1) and heart patients after elective heart~     surgery on the Intensive Care Unit (Phase 2).~      Furthermore, brain function will be measured during exer-gaming with the VRICU device with~     non-invasive instruments (fNIRS/EEG) in both the healthy participants and the heart patients.~      The VRICU device is a patient friendly construction to allow a patient exergaming in bed. The~     project is a cooperation between scientist at the USZ (physiotherapist / anaesthsiologists /~     engineers), human movement scientist at the ETHZ and (poly- / electro-) mechanics at the Paul~     Scherrer Institut.~   "
69197|NCT02661217|"~     To explore two modalities of treatment initiation (Pre-discharge, and Post-discharge) with~     LCZ696 in HFrEF patients following stabilization after an ADHF episode.~   "
69198|NCT02661204|"~     The purpose of this study is to evaluate the diagnostic performance of a new ABUS system~     among 4 different population:~      Population A: women undergoing screening for familial or genetic predisposition for breast~     cancer.~      Population B: women with newly diagnosed breast cancer. ABUS performance will be compared to~     breast MRI in the pre-operative assessment of breast cancer extent.~      Population C: women with BI-RADS 3 or 4 lesions in a routine breast imaging examination. ABUS~     will be evaluate as a problem-solving tool.~      Population D: women undergoing breast MRI for the assessment of breast implants integrity.~     ABUS performance will be compared to breast MRI.~   "
69199|NCT02661191|"~     The study aim is in two phases. First phase: to evaluate the influence of vitamin D~     deficiency on asthma severity, degree of airway obstruction and frequency of asthma~     exacerbations. Second phase: to evaluate if in patients with vitamin D deficiency (25-OH~     vitamin D levels below 20 ng/ml), vitamin D supplementation decreases the number of disease~     exacerbations.~   "
69200|NCT02661178|"~     This study will investigate the safety, tolerability, and pharmacokinetics of single~     ascending doses of emodepside (BAY 44-4400) in healthy male volunteers. This study will also~     conduct an exploratory investigation of the relative bioavailability of emodepside~     administered as tablets and determine the effect of food on the pharmacokinetics.~   "
69201|NCT02661165|"~     This exploratory study is researching how the spirituality of a group of British patients~     with type 2 diabetes (T2D), impacts their approach to the self-management of their condition.~      Bio-statistical markers will be taken from consenting participants' Clinic database records.~     Qualitative interviews will be conducted with participants, and the results analysed and~     interpreted, alongside their bio-statistical markers.~      Results will be presented in healthcare peer reviewed journals and conferences, to inform~     clinicians how patients' self-management of their T2D is influenced by their spirituality.~   "
69202|NCT02661152|"~     Hypoxic modification of radiotherapy with nimorazole has previously been shown to increase~     radiosensitivity in hypoxic head and neck squamous cell carcinomas (HNSCC).~      In Denmark, nimorazole is added the radiotherapy of most HNSCC, as it has not previously been~     possible to discriminate more hypoxic tumours from less hypoxic tumours.~      A hypoxia gene profile has shown to discriminate between responders and non-responders to~     nimorazole.~      In DAHANCA 30, expected hypoxia profile guided non-responders are randomized to +/-~     nimorazole during radiotherapy.This in order to verify clinical use of the gene profile in~     selecting the relevant patients for hypoxic modification of radiotherapy with nimorazole.~   "
69203|NCT02661139|"~     The number of patients requiring major ablative surgery in the oral cavity, including~     partial/radical mandibular or maxillary resection, due to a head and neck carcinoma,~     osteoradionecrosis (ORN), or medication-related osteonecrosis of the jaw (MRONJ) has not been~     accurately reported. Surgical reconstruction to restore oral function and aesthetics forms a~     challenge to maxillofacial surgeons, and greatly impacts patient' quality of life (QOL).~     Recently, an active collaboration between the surgeons of the Oral and Maxillofacial Surgery~     Unit and the prosthodontist (LB) of the Department of Dentistry at the General Hospital~     Saint-John Bruges led to the development of the Oncology-bridge (O-bridge) protocol, which~     offers (immediate/delayed) fixed prosthetic rehabilitation in a minimum of sessions and a~     strongly reduced two-week treatment time, consequently accelerating patient' improved QOL at~     a considerably reduced cost.~      The investigators aim to develop a prospective database in which patient demographics,~     surgical, dental, prosthetic and QOL parameters collected during consecutive visits within~     the framework of routine practice, are being registered for each oncological patient eligible~     for (immediate/delayed) fixed prosthodontic rehabilitation at time of oral cavity~     reconstruction This could provide the investigators with more information about potential~     patient, surgical and prosthetic factors influencing short- and long-term biological and~     mechanical stability, as well as patient QOL. Moreover, registration of those results could~     function as a measurement of quality of care, and could be used for sample size calculation~     for future large prospective trials.~   "
69204|NCT02661126|"~     The purpose of this study is to compare the plasma pharmacokinetics (PK) of single doses of~     MK-3682B [MK-3682/grazoprevir (MK-5172)/ruzasvir (MK-8408) fixed dose combination (FDC)] in~     participants with moderate (Part 1) and severe (Part 2) renal insufficiency (RI) to healthy~     participants.~   "
69205|NCT02661113|"~     Phase II:~      Primary Objectives:~      -To determine the effectiveness of dasatinib (Sprycel) with radiotherapy (RT) and 6 weeks of~     concomitant temozolomide (TMZ) administered at 75 mg/m^2/day followed by adjuvant~     temozolomide with concurrent dasatinib in patients with newly-diagnosed glioblastoma (GBM) as~     measured by overall survival.~      Secondary Objectives:~        -  To determine the efficacy of this treatment as measured by radiographic response (RR),~          progression-free survival (PFS) and time to progression (TTP).~        -  To characterize the safety profile of dasatinib (Sprycel) in combination with RT and~          concomitant TMZ in patients with newly-diagnosed GBM.~        -  To characterize the safety profile of dasatinib (Sprycel) in combination with adjuvant~          TMZ in patients with GBM after RT.~      Exploratory Objectives:~      -To correlate tumor genotype, tumor expression of dasatinib target proteins (e.g. Src, EphA2,~     c-kit and PDGFR), and PTEN levels with response to therapy with dasatinib and temozolomide.~   "
69249|NCT02660541|"~     This is a randomized, controlled, multi-centre, open-label study.~      A total of 40 patients will be enrolled in this study. Patients will be randomly assigned to~     Betafoam® or Allevyn® Silver dressing for burn wounds after acute burn injury.~   "
69207|NCT02661087|"~     Since the development in the last few years of the bipolar energy in the surgery by~     hysteroscopy, the hysteroscopic treatment of the submucosal uterine myoma can be performed by~     use of either monopolar or bipolar current.~      It seems that the use of the bipolar energy decreases the rate of adhesions but prospective~     data on the adhesion rate and fertility after the use of bipolar energy during the surgery~     are poor, and there is currently no recommendation as to the choice of technique to use. The~     main purpose of this study is to compare the rate of uterine adhesions six weeks after the~     surgical hysteroscopic treatment of uterine submucosal myoma, by using monopolar or bipolar~     energy. The pregnancy and spontaneous miscarriage rate will also be evaluated.~   "
69208|NCT02661074|"~     Anisakidae frequently infect fish species that are commonly eaten by humans. Some of them are~     recognized as zoonotic agents, and have a high impact on human health.~      Infestation results from the ingestion of living larvae from contaminated fishes. It can be~     asymptomatic or symptomatic, resulting in acute gastric, acute intestinal or chronic forms.~     Allergic manifestations are frequently encountered in gastric forms, but isolated allergic~     symptoms can occur after ingestion of Anisakidae antigens in raw or cooked fish. Cutaneous~     contact or Anisakis allergen inhalation have also been reported to induce~     allergy/anaphylactic reactions or sensitization in the occupational setting in Spain, Italy,~     Sicilia or South Africa. But no data is available in France.~      In this context, the investigators propose to determine and compare the frequency and~     characteristics of fish allergy in fish workers (fishermen and fish-processing factory~     workers) and a control population of workers without occupational exposure to fish, in~     Boulogne-sur-Mer, which is an important fishing port in France, and the first European center~     for fish processing.~   "
69209|NCT02661061|"~     Randomised, controlled, parallel-group, pilot clinical trial of ketamine vs. midazolam for~     depression relapse prevention in persons at high risk. The main purpose of the pilot study is~     to assess trial processes to help inform a future definitive trial.~   "
69210|NCT02661048|"~     The objective of this clinical investigation is to evaluate:~        1. the safety and efficacy of the CyberHeart System, CardioPlan™ Software and Laptop, in~          treating patients with refractory ventricular tachycardia (VT) using the CyberKnife®~          Radiosurgical System.~        2. The CyberHeart System performance with respect to the ability to contour myocardial~          targets that are transferred to the Multi-plan® Treatment Planning Software of the~          CyberKnife® system for the production and delivery of a safe radiosurgical treatment~          plan.~      Cardiac radiosurgery is a minimally-non invasive, painless, procedure. Tissue ablation can be~     accomplished precisely.~   "
69211|NCT02661035|"~     This is a phase II trial using a non-myeloablative cyclophosphamide/ fludarabine/total body~     irradiation (TBI) preparative regimen followed by a related or unrelated donor stem cell~     infusion. The primary objective is to evaluate rates of acute graft-versus-host disease~     (GVHD) grades II-IV and chronic GVHD with an updated GVHD prophylaxis of tacrolimus and~     mycophenolate mofetil (MMF) with a non-myeloablative preparative regimen in persons with~     hematologic malignancies.~   "
69212|NCT02661022|"~     A Phase 1/2, Open Label Study of SL-401 in Combination with Pomalidomide and Dexamethasone In~     Relapsed and Refractory Multiple Myeloma~   "
69213|NCT02661009|"~     In this clinical trial, investigators select FFPE and plasma samples of non-small cell lung~     cancer which are used for quantitative detection of four kinds of EGFR(Epidermal Growth~     Factor Receptor) mutations. By the following two aspects, investigators evaluate the clinical~     performance of the EGFR quantitative kits.~        1. methodology validation: To certify the equivalence between the EGFR quantitative kit and~          the common used detection methods.~        2. analysis of the relationship between the type and proportion of EGFR sensitive mutation~          and EGFR-TKI benefit.~   "
69214|NCT02660996|"~     The objective of this observational study is to assess the effectiveness of the Advocate~     Lutheran General Survivorship Center's Programs by measuring the following outcomes of~     interest on participating patients:~        1. Quality of life~        2. Distress level~        3. Satisfaction with the Survivorship Program~      General Hypothesis: Patients who participate in at least four classes in a two month period~     will have higher scores on the post-class satisfaction, quality of life, and distress surveys~     compared to their pre-class surveys.~   "
69215|NCT02660983|"~     The primary objectives are to confirm that donepezil hydrochloride has superior efficacy in~     improving cognitive function, as measured by Alzheimer's Disease Assessment Scale-Cognitive~     subscale (ADAS-cog), and to demonstrate that donepezil hydrochloride has superior efficacy in~     improving global function, as measured by Clinician's Interview-Based Impression of~     Change-plus Caregiver Input (CIBIC-plus), compared with placebo in patients with dementia~     associated with cerebrovascular disease (VaD)~   "
69216|NCT02660970|"~     Functional gastrointestinal disorders are common disorders that are characterized by~     persistent and recurring GI symptoms. These occur as a result of abnormal functioning of the~     GI tract and are not caused by structural or biochemical abnormalities. As a result, medical~     tests- such as blood tests and endoscopic exams- have essentially normal/negative~     (non-disease) results. More than 20 functional GI disorders have been identified. They can~     affect any part of the GI tract. One of the most common functional disorders is nausea and~     dyspepsia (pain or discomfort in the upper abdominal area, feeling of fullness, bloating).~     Any chronic illness, including functional nausea, will affect a person's health-related~     quality of life (general well-being, ability to carry out everyday activities), additional~     psychosocial disturbances and amplify the experienced illness.~      The majority of children suffering from functional nausea in Europe are treated with~     Iberogast®. a herbal mixture, whose effect was demonstrated in several studies. Since~     Iberogast® is not available in the United States of America, children there receive an~     acupressure therapy. The American gastroenterologists refer hereby to several studies, which~     have shown, that the positive effect of such therapies in patients with chemotherapy-induced~     nausea is even greater than a therapy with ondansetron. Since acupressure is able to reduce~     somatic nausea, it is also believed to decrease functional nausea, but it has never been~     investigated. Therefore, there are no data. That's why Investigators want to compare the~     efficacy of these two therapies, that is, Iberogast® and acupressure~   "
69217|NCT02660957|"~     The purpose of this study is to test the effectiveness of using a brief, self-determination~     intervention on smoking cessation (immediate or progressive) for people attending AEDs.~   "
69219|NCT02660931|"~     This proposal will incorporate statistical models developed by the investigators to predict~     risk for acute kidney injury into our electronic medical record system, enabling an alert to~     notify providers of the risk status. Pediatric inpatients will be randomly assigned to be in~     the intervention group, for whom the notification will be implemented, or in the control~     group, who will receive usual care (no notification). The investigators believe the~     notification will increase appropriate screening for acute kidney injury and reduce the~     severity of acute kidney injury in the intervention group.~   "
69220|NCT02660918|"~     To determine whether paracervical injection of long acting local anesthesia decreases~     postoperative pain following endometrial ablation under general anesthesia.~   "
69221|NCT02660905|"~     This is an prospective open label pilot study conducted over 32 weeks.~      A total of 25 eligible participants who are infected with HCV and HIV will be recruited from~     2 Canadian HIV Trials Network (CTN) sites (Ottawa Hospital Research Institute and McGill~     University Health Centre)~      This study is looking into the effectiveness of a combination of~     Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Alafenamide Single Tablet Regimen (E/C/F/TAF~     STR) for HIV treatment and Harvoni for HCV treatment .~      This study will assess the effect that the study drug has on the metabolism of sugar, the~     changes in fat in the bloodstream and other metabolic changes. Metabolism is the process your~     body uses to get or make energy from the food you eat.~      This study may provide information on the impact of liver fibrosis (scarring of liver~     tissues) on metabolic changes before, during and after HCV antiviral therapy.~      Drug-drug interactions (DDI) DDI between E/C/F/TAF and LPV-SOF have been well evaluated and~     no clinically significant interactions have been identified.~      A switch to E/C/F/TAF in the context of LPV-SOF HCV antiviral treatment preparation may be~     particularly beneficial because of its:~        1. favorable side effect profile~        2. once daily STR formulation~        3. known DDI profile with LPV-SOF~        4. neutral effect on liver fibrosis~        5. improved kidney and bone safety profile with the use of TAF~      Conduct of this study is justified as it:~        1. Assesses a minimal pill count and dosing frequency strategy of co-treatment of HIV and~          HCV using well tolerated medications with an excellent safety profile and known DDI~          profile.~        2. Provides additional safety data for TAF in the HIV-HCV co-infected population.~        3. Quantifies adherence and identifies obstacles to full adherence in this population.~          There is a paucity of data related to DAA adherence in licensing studies.~        4. Provides real-world safety and efficacy data to support the public funding for LPV-SOF~          DAA therapy in HIV-HCV co-infected populations.~        5. Provides preliminary data on the immunologic and metabolic consequences of HCV clearance~          in HIV-HCV co-infection~        6. As a pilot study, the information gathered will inform the feasibility of future~          clinical trials evaluating novel treatment strategies for HIV-HCV co-infected patients.~   "
69222|NCT02660892|"~     Threonine is an indispensable amino acid (nutrient containing nitrogen), which cannot be made~     in the body and must be consumed from food. Amino acids are the building blocks of protein in~     your body, and need to be eaten in required amounts to maintain health and growth. Deficiency~     in threonine can affect small intestine growth due to its structural importance in the~     intestinal protein mucin. While threonine is found in many foods, deficiency can occur in~     developing countries where nutrition is primarily plant based, and low in available protein.~      Therefore, the purpose of this study is to determine the requirement of the indispensable~     amino acid Threonine, in school-aged children (6-10y). Secondly, we wish to determine the~     availability of threonine from three test proteins (soy, green pea, casein).~   "
69223|NCT02660879|"~     The investigators looked at the effect that video instruction located at www.useinhalers.com~     would have on improving inhaler technique at a hospital in Guayaquil, Ecuador. The~     investigators compared this video instruction to written Spanish inhaler education. The~     investigators video taped participants before and after the intervention, and graded their~     technique on a pre-defined rubric.~   "
69224|NCT02660866|"~     This is a Phase 4, randomized clinical trial to evaluate whether addition of Vorapaxar 2.08~     mg daily vs. placebo daily on background antiplatelet therapy, prescribed for 6 months to~     patients with established peripheral artery disease (PAD) and Intermittent Claudication (IC)~     treated with standard medical therapy (SMT) would lead to an improvement in the peak walking~     time (PWT).~   "
69225|NCT02660853|"~     The purpose of this study is to investigate exacerbations in severe asthma with regard to~     symptoms, lung function, aetiology and biomarkers.~   "
69226|NCT02660840|"~     To establish bioequivalence between new film-coated tablet formulations of 0.5 mg, 1 mg and 5~     mg flupentixol and the marketed coated tablet formulations of 0.5 mg, 1 mg, and 5 mg~     flupentixol, administered as single doses~   "
69227|NCT02660827|"~     This study is a single-arm, multi-center, Home and Hotel Clinical Investigation in pediatric~     subjects with type 1 diabetes on insulin pump therapy. The purpose of this study is to~     demonstrate that the closed loop algorithm that is built into the 670G insulin pump is safe~     as part of the overall system.~   "
69228|NCT02660814|"~     The objective in this case-control intervention study, therefore, was to explore the effect~     of nonsurgical periodontal therapy on the GCF levels of chemerin and IL-6 in patients with~     chronic periodontitis in order to determine the usefulness of chemerin as a diagnostic and~     prognostic biomarker of periodontal disease.~   "
69229|NCT02660801|"~     The objective of the present study is to compare the neuromechanical responses to spinal~     manipulation and spinal mobilization in participants with and without chronic nonspecific~     back pain.~   "
69230|NCT02660788|"~     A randomized, double-blinded study conducted in British Columbia, Canada, where there is a~     publicly funded, organized screening program and screening mammography is recommended at~     24-month intervals. Eligible women aged 51-73 years old and overdue for their screening~     mammogram by 6-24 months are identified in the database of the Screening Mammography Program~     of BC (SMPBC). Family physicians are recruited by mail and asked to sign letters to the~     overdue women in their practices. The overdue women are randomized and mailed either the~     signed reminder letter and the standard reminder postcard, or the standard reminder postcard~     alone. The primary endpoint is the proportion of overdue women attending a screening~     mammogram appointment 6 months after the mailing.~   "
69244|NCT02660606|"~     The purpose of this study is to evaluate the patient usability and reliability of the POMAQ~     survey to evaluate opioid misuse and abuse among adults with chronic moderate to severe pain,~     including patients who are opioid abusers, non-abusers, as well as non-opioid users~   "
69245|NCT02660593|"~     MedlinePlus related topics: Blood Sugar~      Primary Outcome Measures:~        -  Fast glucose and HbA1c change between the baseline and end of study [ Time Frame: From~          baseline to 30 and 100 days]~        -  [ Designated as safety issue: No ]~        -  Successful rate of blood glucose control (the proportion of patients with HbA1c <7%) [~          Time Frame: From baseline to 30 days and 100 days] [ Designated as safety issue: No ]~      Secondary Outcome Measures:~      • To evaluate the change of quality of life in the 1 months by the health questionnaire SF-36~     [ Time Frame: From baseline to month 1 ] [ Designated as safety issue: No ]~   "
69231|NCT02660775|"~     In people with schizophrenia or people with autism, impairments of social cognition are a~     core feature of the disease and, according to researchers who represent valuable references~     on this subject for the international community, three to five processes of social cognition~     are usually altered in those diseases: (1) emotional processing which is the ability to~     identify emotions through facial expressions, gestures, and tone of voice, (2) theory of mind~     (ToM), which is defined as the ability to attribute mental states (beliefs, intents,~     desires, …) to oneself and others, and to understand that others have beliefs, intentions,~     and desires that are different from one's own, (3) attributional style which refers to how~     people explain the causes of positive and negative events, and corresponding, in~     schizophrenia, to self-serving and personalizing bias that means a tendency to blame others~     for negative life events rather than sharing the responsibilities between different sources;~     and (4 and 5) social perception and knowledge, which can be defined as decoding and~     interpreting social cues from others, taking the social context into account, and knowing~     social rules, roles, and goals. Components of social cognition appear to be related to both~     symptomatology and functioning in everyday life. The present study aims to assess a new~     social cognitive battery developed by several teams in France: ClaCoS.~   "
69232|NCT02660762|"~     This prospective study was conducted to evaluate the efficacy and safety profiles of Modified~     MRCUKALLⅫ/ECOGE2993 Regimen in young adults with newly diagnosed, low-risk, Philadelphia~     chromosome negative acute lymphoblastic leukaemia.~   "
69233|NCT02660749|"~     Non Coronary Heart Surgery scheduled for the study , in patients with acute postoperative~     period Use of tramadol retard, metamizol and dekxketoprofen the effects on pain and character~     has been seen in the chronic phase targeted.~   "
69234|NCT02660736|"~     Albiglutide (Alb) is a novel analogue of glucagon-like peptide-1 (GLP-1) has been developed~     and approved for the treatment of type 2 diabetes mellitus. Currently, lyophilized~     albiglutide and the diluent are provided in a dual chamber Cartridge (DCC) single-dose pen~     injector, requiring reconstitution prior to use. A liquid formulation of albiglutide will~     enable the use of a liquid product in a ready-to-use single dose auto-injector. To support~     the development of the liquid auto-injector product, this healthy volunteer bioequivalence~     study will be conducted to compare the liquid drug product to the currently available~     lyophilized product. This is Phase I, randomized, double-blind, double dummy, single-dose,~     2-period crossover study in healthy volunteers. This study will compare the pharmacokinetics~     and safety of the albiglutide 50 mg liquid drug product with the albiglutide 50 mg commercial~     lyophilized drug product.~   "
69235|NCT02660723|"~     The main goal of this study is to investigate the impact of aging on the responsiveness of~     peripheral blood immune cells. To this aim, the investigators will take advantage of a~     recently described syringe-based assay system that can reproducibly assess induced, innate or~     adaptive immune responses. Briefly, a total of 50 healthy volunteers will participate to this~     study: 25 will be older than 18 and younger than 30, and 25 will be older than 55. A total of~     14 ml of blood will be drawn including 5 X 1 ml in TruCulture™ tubes containing poly(I:C),~     R-848, LPS, CpG, or no stimulus, respectively. After 22 hours of incubation at 37°C, cellular~     supernatants will assessed for levels of 10 different chemokines using a MesoScaleDiscovery~     multiplexing platform.~   "
69236|NCT02660710|"~     The purpose of this study is to establish the safety of rituximab plus cyclophosphamide,~     doxorubicin, vincristine,prednisone (R-CHOP) in HIV-infected and HIV-uninfected diffuse large~     B-cell lymphoma (DLBCL) patients in Malawi.~   "
69237|NCT02660697|"~     The present retrospective study aims at assessing the clinical effects of a novel implant~     site development (Extraction site development - XSD) technique after tooth extraction~     compared with extraction alone in patients requiring dental implant placement following~     healing of extraction sockets.~   "
69238|NCT02660684|"~     The objective of this study is to assess the safety and efficacy of Tacrolimus (Prograf~     capsule, Prograf injection) and Methotrexate combination therapy for GVHD prophylaxis in~     patients who received peripheral hematopoietic stem cell transplantation from a sibling~     donor, and to compare with data from a historical control group that administered a~     conventional Cyclosporine formulation.~   "
69239|NCT02660671|"~     This is an RCT aimed at testing different population-based approaches to increasing~     colorectal cancer screening through email outreach, including usual email communication,~     active choice, and active choice + financial incentive.~   "
69240|NCT02660658|"~     Spinal anesthesia is a commonly used technique for lower limb surgeries offering better~     quality of postoperative analgesia, lower incidence of side effects, and shorter~     post-anesthesia care unit stay than general anesthesia. However, the relatively short~     duration of action of the currently available local anesthetics (LAs) make these advantages~     short-lived.~      The risk for local anesthetic toxicity (LAST) increases with the trials to use higher~     concentrations or volumes of intrathecal local anesthetics to increase the duration of~     analgesia.~      Dexmedetomidine has the potential to prolong the duration of perioperative analgesia without~     the need for using high doses of local anesthetics and hence with decreasing the potential~     risk of local anesthetic, but the increased likelihood adverse effects such as short term~     bradycardia and prolonged duration of motor block may offset these benefits.~   "
69241|NCT02660645|"~     Registry study to gather more information on the current use of Blue Light Cystoscopy with~     Cysview (BLCC) in urologists' practices.~   "
69242|NCT02660632|"~     Pulmonary complications are among the most important postoperative complications after~     midline incisions, for which different analgesic modalities have been tried.~      Epidural analgesia is the recommended technique to relieve pain after major abdominal surgery~     owing to the proved superior analgesia, reduction of opioid related side effects as nausea,~     vomiting, pruritis and sedation, earlier recovery of bowel function and earlier ability for~     postoperative mobility However, it is not without complications.~      Rectus sheath block provides several advantages over epidural anesthesia. It lessens the~     potential risks associated with neuraxial techniques, so it may represent a novel alternative~     approach for somatic analgesia after major abdominal surgeries. Although patients with rectus~     sheath block may experience some visceral pain, it is usually minimal by 24 hours after~     surgery.~   "
69243|NCT02660619|"~     The purpose is to validate the PRISM-5-Op as a measurement of prescription opioid substance~     use disorder.~   "
69251|NCT02660515|"~     Open reduction and internal fixation of intra-articular distal radius fractures leads to~     better functional outcomes the first 6 months compared to non-operative treatment. However,~     some patients continue to have a painful and stiff wrist post-operatively. Arthroscopically~     assisted removal of intra- articular fracture haematoma and debris may reduce pain and~     improve the functional outcomes following operative treatment of intra-articular distal~     radius fractures. Moreover, during arthroscopy the quality of the reduction and the presence~     of associated ligamentous injuries can be assessed. Therefore the objective of this study is~     to compare the functional outcome of internal plate fixation with additional wrist~     arthroscopy versus conventional fluoroscopic assisted internal plate fixation in adult~     patients with displaced intra-articular distal radius fractures.~   "
69252|NCT02660502|"~     This is a double-blind, randomised, three period crossover phase 1 trial using automated~     8-hour euglycemic clamps in healthy Japanese subjects.~      Each subject will be randomly allocated to one out of nine sequences to receive either three~     single doses of BioChaperone insulin lispro or one single dose of Humalog® and two single~     doses of BioChaperone insulin lispro on three separate dosing visits.~      The total trial maximum duration for a subject will be up to 10 weeks.~   "
69253|NCT02660489|"~     The aim of this study is to assess the effectiveness of a CRTH2 receptor antagonist, OC459,~     in preventing or attenuating the symptoms of an asthma exacerbation after rhinovirus~     infection. The study is a double blind, randomised trial in which half the subjects will~     receive OC459 and the other half placebo, before being inoculated with rhinovirus, that would~     normally induce a worsening of asthma symptoms i.e. an exacerbation.~   "
69254|NCT02660476|"~     QUDOS is a cross-sectional population study aiming to answer key questions about diabetes and~     its complications in Qatar as well as identify factors associated with the development and~     progression of diabetes complications.~   "
69255|NCT02660463|"~     The incidence of chronic thromboembolic pulmonary hypertension (CTEPH) after acute pulmonary~     embolism ist not clear. It is estimated to be up to 3.8%. Prospective data registration does~     not exist. Treatment of choice is pulmonary endarterectomy if the thromboembolic lesions are~     surgically accessible. Otherwise interventional therapy by means of pulmonary~     balloon-angioplasty (BPA) or medical therapy is indicated. In Germany, the majority of the~     patients is referred to three CTEPH centers: Kerckhoff Clinic, Saarland University Hospital~     and Hannover Medical School to evaluate the therapeutic options. Starting in January 2016 all~     incident patients will be de-identified and included prospectively. Risk factors, outcome and~     treatment will be documented.~   "
69256|NCT02660450|"~     Current literature report 3 ways to prescribe and control aerobic training. Such models~     require comparison to determine if they really provide the same impact training in a~     prescription. The aim of this study is to compare the results of different methods of~     prescription of aerobic training, ie VO2 workload, heart rate (HR), and load self adjusted by~     perceived effort (PSE) as well as psychological responses activation, and feel depending on~     the stimuli offered.~   "
69257|NCT02660437|"~     Investigators wish to identify a relationship between substantial changes in carbon dioxide~     partial-pressure (pCO2), which frequently occur during the transitions from rest to exercise~     (ΔpCO2 >4 millimeters of mercury [mmHg] from baseline), and the prevalence of cognitive~     dysfunction in COPD. In particular, it is anticipated to investigate the vascular effect of~     pCO2 oscillations in the regulation of cerebral blood flow (CBF) during exercise and its~     impact on cognitive function in Chronic Obstructive Pulmonary Disease (COPD). Furthermore,~     this study aims to examine whether major pCO2 oscillations have prognostic value in cognitive~     deterioration at 6, 12, and 18-month follow-up. In addition, the acute effect of 3-week~     pulmonary rehabilitation (PR) on cognitive function will be explored. The evaluation of~     cognitive function will be performed by the use of Standardized Mini Mental State Examination~     (SMMSE), Addenbrooke's Cognitive Examination (ACE-R), Montreal Cognitive Assessment (MoCA),~     and Telephone Interview for Cognitive Status (TICS) assessing several cognitive domains~     (cognitive scores) whereas Stroop test [color reading interference] will be used for~     measuring cognitive performance (Reaction-Time).~   "
69258|NCT02660424|"~     The Primary objective of this study is to evaluate the efficacy of VX-150 in the treatment of~     osteoarthritis pain~   "
69259|NCT02660411|"~     Surgery is one of the major treatment methods for patients with malignant tumor. And, alone~     with the ageing process, more and more elderly patients undergo surgery for malignant tumor.~     Evidence emerges that choice of anesthetics, i.e., either inhalational or intravenous~     anesthetics, may influence the outcome of elderly patients undergoing cancer surgery. From~     the point of view of immune function after surgery and invasiveness of malignant tumor cells,~     propofol intravenous anesthesia may be superior to inhalational anesthesia. However, the~     clinical significance of these effects remains unclear. Retrospective studies indicated that~     use of propofol intravenous anesthesia was associated higher long-term survival rate.~     Prospective studies exploring the effect of anesthetic choice on long-term survival in cancer~     surgery patients are urgently needed.~   "
69260|NCT02660398|"~     This prospective study will take place at Harborview Medical Center (HMC) and the University~     of Washington Medical Center (UWMC), and will enroll adult patients undergoing abdominal~     surgery. The purpose of this study is to identify if the use of a specific plan to managing~     muscle relaxants will help decrease the risk of muscle weakness after general anesthesia with~     muscle relaxation in a population of patients undergoing abdominal surgery.~   "
69284|NCT02660086|"~     This project tests a scalable and sustainable approach to weight gain prevention in a~     population of employees by using the worksite environment to deliver personalized feedback~     about worksite food purchases, daily calorie goals, social norms for healthy eating, and~     financial incentives for healthy food purchases. In the future, similar strategies could be~     adopted by other worksites, institutions, and food retailers and could contribute to the~     long-term environmental and social changes needed to reverse the obesity epidemic in the~     United States and worldwide.~      The overall objective of ancillary studies added on to this project is to examine the~     psychological traits, cognitive skills, and genes that may influence the impact of the~     behavioral intervention to promote healthy diet and weight among employees at a large~     hospital worksite.~   "
69746|NCT02654041|"~     The objective of the study is to assess the safety and efficacy of treatment with~     hypothyroxinemia adjunct to conventional therapies in GBM patients.~   "
69261|NCT02660385|"~     Chronic insomnia may contribute to the development and exacerbation of heart failure (HF),~     incident mortality and contributes to common and disabling symptoms (fatigue, dyspnea,~     anxiety, depression, excessive daytime sleepiness, and pain) and decrements in objective and~     subjective functional performance.~      The purposes of the study are to evaluate the sustained effects of CBT-I on insomnia~     severity, sleep characteristics, daytime symptoms, and functional performance over twelve~     months among patients who have stable chronic HF and chronic insomnia. The effects of the~     treatment on outcomes of HF (hospitalization, death) and costs of the treatment will also be~     examined.~      A total of 200 participants will be randomized to 4 bi-weekly group sessions of cognitive~     behavioral therapy for CBT-I (behavioral was to improve insomnia and sleep) or HF~     self-management education.~      Participants will complete wrist actigraph (wrist-watch like accelerometer) measures of~     sleep, diaries, reaction time, and 6 minute walk test distance. They will also complete~     self-report measures of insomnia, sleep, symptoms, and functional performance. In addition~     the effects on symptoms and function over a period of one year.~   "
69262|NCT02660372|"~     The aim of this study is to show non-inferiority of two brands of simeticone in adult~     patients suffering from functional dyspepsia.~   "
69263|NCT02660359|"~     The purpose of this study is to provide confirmatory evidence of the safety and efficacy of~     two Dysport® doses (600 units [U] and 800 U), compared to placebo in reducing urinary~     incontinence (UI) in adult subjects treated for neurogenic detrusor overactivity (NDO) due to~     spinal cord injury (SCI) or multiple sclerosis (MS).~   "
69264|NCT02660346|"~     Patients with MRSaB have high therapeutic failure rates and mortality rates. Recent studies~     have shown that an elevated IL-10 level is an independent risk factor of mortality. It may~     also serve as biomarker for very early risk stratification. The aim of this study is to~     compare the outcomes for patients with elevated IL-10 levels (≥8 pg/ml) when treated with~     standard antibiotic therapy (daptomycin or vancomycin) versus early aggressive therapy~     (daptomycin with ceftaroline) for the treatment of MRSaB.~   "
69265|NCT02660333|"~     The purpose of this study is to evaluate the effect of prebiotic or synbiotic supplementation~     on inflammatory response and indicators of nutritional status in patients with morbid~     obesity. Study hypothesis: Supplementation of 12 g/day of fructooligosaccharides (prebiotic)~     or 12 g/day of fructooligosaccharides + strains of lactobacilli and bifidobacteria~     (synbiotic) during 30 days promotes reduction of plasma/serum levels of acute phase proteins,~     cytokines, metabolic and anthropometric parameters in individuals with BMI ≥ 40kg/m².~   "
69266|NCT02660320|"~     Principal objective: To compare the efficacy of laser-assisted dermabrasion + autologous~     epidermal cells suspension grafting versus dermabrasion using micro-needling technique +~     autologous epidermal cells suspension grafting and dermabrasion using micro-needling~     technique + placebo suspension grafting in stable vitiligo.~      A total of 10 patients with stable non-segmental vitiligo will be included in the ITT~     population.~      In each patient, three separate test areas will be selected in the same part of the body.~      One area will be pre-treated with dermaroller and receive the hyaluronic acid suspension~     alone and the two others will receive the epidermal cell suspension in hyaluronic acid after~     pre-treatment either with dermaroller or laser-assisted dermabrasion, each patient being his~     own control.~      Targeted phototherapy with excimer lamp (308 nMm) will be applied on all test areas 1 week~     after cell grafting.~   "
69267|NCT02660307|"~     This protocol proposes a well-being program based in stress reduction program for employees~     of a company.~      objectives: To evaluate the effects of a stress reduction program with a specific orientation~     for workers and taught to them within their companies.~      Methods: Participants with stress complaints were recruited and randomized into two groups:~     group 1 (G1) received the intervention while group 2 (G2) did not. Both groups were evaluated~     before the intervention (time 1 - T1); again after the eight weeks of the program for G1~     (time 2 - T2); and then at the end of a second eight-week period during which G2 received the~     intervention and G1 was simply instructed to maintain the practice they had learned without~     further instruction (time 3- T3).~   "
69268|NCT02660294|"~     Successful embryo implantation needs an optimum embryonic development with a receptive~     endometrium. Endometrial thickness is an independant factor for endometrial receiptivity. The~     aim of that trial is to assess the benefecial effect of platelt rich plasma in copmarison~     with standard hormonal therapy.~   "
69269|NCT02660281|"~     This study will be a single-center treatment protocol, designed to validate the process of~     related donor haploidentical-SCT at the Wilmot Cancer Institute Blood and Marrow Transplant~     Unit.~   "
69270|NCT02660268|"~     The main objective is to determine the contribution of a clinical pathway to improve the~     effectiveness of medico-surgical management of hip prosthesis infections in terms of clinical~     cure. The hypothesis raised is that the implementation of a clinical pathway would improve~     the performance of the medical and surgical management of chronic infections of prosthetic~     hip.~   "
69271|NCT02660255|"~     This is an observational, open-label, flexible dose study that will prospectively and~     longitudinally assess the effect of Cannabidiol (CBD) therapy in patients with drug-resistant~     epilepsies through a Physician Expanded Access Investigational New Drug protocol.~   "
69272|NCT02660242|"~     This project focuses on development of new strategy for the prevention of exercise-associated~     hypoglycemia using mini-dose glucagon.~   "
69273|NCT02660229|"~     The purpose of this study is to compare of difference in NRS scores from baseline to the~     completion of treatment (5 days) in patients taking morphine sulfate versus oxycodone~     hydrochloride.~   "
69311|NCT02659722|"~     The primary objective of this prospective, post-market study is to collect data to assess the~     long term outcome of a broad contact modular interbody device in the form of the InterFuse S™~     or InterFuse T™ device in patients undergoing long construct fusion for degenerative disc~     disease and/or scoliosis. Comparisons will be made with published historical data..~   "
69312|NCT02659709|"~     Develop smartphone- and tablet-based application (app) for participants with glaucoma, ocular~     hypertension and those at risk.~   "
69747|NCT02654028|"~     This prospective study aims to determine whether autotransfusion of red blood cells salvaged~     during liver resection is associated with the recurrence of hepatocellular carcinoma.~   "
69274|NCT02660216|"~     Nowadays, maxillary Le Fort I osteotomy is a safe and routinely performed procedure. The~     conventional approach is characterized by a vestibular incision extending from~     molar-to-molar, associated with a pterygomaxillary disjunction performed with a curved~     chisel. Adequate mobilization of the maxilla during Le Fort I osteotomy requires an effective~     separation of the maxillary tuberosity from the pterygoid plates of the sphenoid bone.~     However, as initially described by Precious (1991) and later by Hernandez-Alfaro (2013), a~     true pterygomaxillary osteotomy is not necessary to achieve successful disjunction.~     Furthermore, Hernandez-Alfaro combined his technique of pterygomaxillary disjunction, the~     so-called Twist technique, to a minimally invasive protocol, performing the complete Le~     Fort I osteotomy through a 20 to 30 mm long horizontal vestibular incision. Although~     promising, the technique remains highly sensitive from a technical standpoint, and its true~     accuracy has not been comprehensively evaluated.~      The purpose of this study is to present and validate a minimally invasive approach towards Le~     Fort I osteotomy, using a modified pterygomaxillary (PTM) disjunction technique. The primary~     outcome is to evaluate the accuracy of the technique using rigid voxel-based registration of~     the 3D virtual treatment planning and the 4 weeks postoperative CBCT images. Secondary~     outcomes include the surgical time necessary to complete the procedure and the presence of~     intraoperative and early postoperative complications.~   "
69275|NCT02660203|"~     Following thoracic surgery, pleural effusion in pleural cavity requires post-operative~     drainage.~      Pleural effusion is responsible for pulmonary congestion, atelectasis, hypoventilation, lower~     efficacy of diaphragmatic curse, lower pulmonary reexpansion and vicious attitude. These~     complications could be avoided by respiratory physiotherapy.~      Forced expiration technic in ipsilateral decubitus is one of these technics but has never~     been proved better than other technics regarding its efficiency.~      The aim of the study is to compare the impact of such a technic on post operative thoracic~     drainage after pulmonary, pleural or mediastinal pediatric surgery.~   "
69276|NCT02660190|"~     Photodynamic diagnostic (PDD) is a technique where a photodynamic drug is installed~     preoperatively in the bladder. Mucosa cells with a higher metabolism than normal urothelial~     cells, e.g. cancer cells, absorbs this drug which is utilized during cystoscopy where blue~     light is absorbed by the drug, making the surgeon able to distinguish tumor cells from normal~     cells and thus being able to identify flat lesions and small papillomas missed in white light~     cystoscopy.~      The use of PDD at this primary transurethral resection of bladder tumour (TURB) has been~     shown to be associated with a lower recurrence rate within the first year, probably mostly~     owing to a higher detection rate of small papillomas and dysplasia that therefore can be~     relevantly treated at an early stage.~      Despite the use of PDD at the primary TURB, a high number of patients experience an early~     recurrence and patients with carcinoma in situ (CIS) treated with bacillus Calmette-Guerin~     (BCG) may have recurrence of their CIS or recurrence of papillomas despite the peroperative~     use of PDD.~      Whereas the use of PDD is well established in the TURB setting, the use of PDD in the~     follow-up setting with flexible cystoscopy in the outpatient clinic is not investigated.~     Feasibility studies have been successful but the clinical relevance and benefits have not~     been investigated so far.~      Thesis The thesis of the study is that the use of PDD in the outpatient clinic in patients~     with a high recurrence risk undergoing follow-up flexible cystoscopy will result in diagnosis~     of papillomas earlier than by the use of conventional flexible cystoscopy in white light.~     Thus, a higher number of tumours can be treated in the outpatient setting without the need~     for procedures in general anesthesia. Furthermore, the number of follow-up cystoscopies can~     be reduced if PDD is used at the first cystoscopy following TURB.~      Aims To investigate whether the use of PDD when performing a flexible cystoscopy in the~     outpatient clinic can reduce the number of recurrences of large size papillomas that cannot~     be treated by simple fulguration without general anesthesia. Furthermore, to investigate~     whether the use of PDD in follow-up cystoscopy in patients with earlier complete response to~     BCG on CIS, can increase the detection rate of CIS recurrences.~   "
69277|NCT02660177|"~     This study aims to assess the PK parameters of metamizole following a single IV~     administration of metamizole in children less than 6 years of age.~   "
69278|NCT02660164|"~     The objective of the study is to evaluate, in a blinded fashion, the effectiveness of the~     Nautilus BrainPulse device when used as an aid in the diagnosis of concussion.~   "
69279|NCT02660151|"~     The Hyper-CL™ lenses are indicated for therapeutic use as a bandage to protect the corneal~     surface and to relieve corneal pain in the treatment of acute or chronic ocular pathologies,~     such as bullous keratopathy, corneal erosions, entropion, corneal edema, and corneal~     dystrophies as well as post-surgical conditions resulting from cataract extraction and~     corneal surgery. The lenses may be prescribed for daily wear with removal for cleaning and~     disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care~     professional.~      In addition Hyper-CL™ contact lenses can also provide optical correction during healing if~     required.~   "
69280|NCT02660138|"~     The purpose of this study is to provide confirmatory evidence of the safety and efficacy of~     two Dysport® (AbobotulinumtoxinA) doses (600 units [U] and 800 U), compared to placebo in~     reducing urinary incontinence (UI) in adult subjects treated for neurogenic detrusor~     overactivity (NDO) due to spinal cord injury (SCI) or multiple sclerosis (MS).~   "
69281|NCT02660125|"~     Midluteal single endometrial strip will be taken using a Novak curett under general~     anasthesia to avoid discomfort and cramping and to proceed to cervical dilatation in case of~     forbidden cervix, the step that will be beneficial to embryo transfer procedure.~      Controller ovarian hyperstimulation; will be done using the long luteal phase agonist~     protocol and the short protocol(as judged by patient,s age ovarian reserve judged by day 3~     FSH and antral follicular count and previous history of ovarian response).~      Ovarian response will be monitored by vaginal ultrasound and HCG will be given when when~     there is >=1 follicle >=18 mm. and >=3 follicles >=16 mm. Ultasound guided oocyte retrieval~     will be carried out 35 hours later. Embryo transfer will be performed on day 2 or day 3 after~     oocyt retrieval according to number and quality of embryos.~      Embryo transfer will be carried out under trans-abdominal ultrasound guidance pregnancy test~     will be done using qualitative blood HCG detection 2 weeks after the embryo transfer.~   "
69282|NCT02660112|"~     This 24-week study will test the safety and effectiveness of synthetically produced (+)~     Epicatechin in treating patients who have Friedreich's Ataxia, a neurological disorder.~   "
69283|NCT02660099|"~     The aim of this study is to test the feasibility and acceptability of an internet-delivered~     cognitive behavior therapy (ICBT) intervention originally developed for neurotypical~     adolescents with obsessive compulsive disorder (OCD) in adolescents with OCD and autism~     spectrum disorder (ASD). This feasibility study will inform us how to adapt the original~     intervention to the specific needs of patients with ASD.~   "
69313|NCT02659696|"~     Nalfurafine hydrochloride is a selective kappa-opioid receptor agonist developed in Japan,~     and in May 2015 the use of nalfurafine hydrochloride was officially approved in Japan for~     pruritus in patients with chronic liver diseases including PBC. In the current study, the~     investigators aimed to assess pruritus and overall QOL before and after administration of~     nalfurafine hydrochloride in patients with PBC. Furthermore, the investigators took serum~     sample from the enrolled patients and examine the association of pruritus with possible~     biomarkers.~   "
69285|NCT02660073|"~     Spinal cord injury (SCI) is a devastating medical problem that affects thousands of civilian~     and military personnel in the United States. Spinal cord injuries (SCI) predispose~     individuals to impaired fitness, obesity, glucose intolerance and insulin resistance, placing~     them at greater risk for diabetes and coronary artery disease. These are devastating problems~     that occur frequently because of changes in body composition and reduced level of physical~     activity. Skeletal muscle wasting plays a central role in altered metabolism after SCI.~     Functional electrical stimulation (FES) is an effective rehabilitation tool that has been~     used to train the paralyzed skeletal muscles and which has shown some ability to ameliorate~     the deleterious effects of SCI on metabolism, particularly on insulin sensitivity. However,~     its ability to reverse skeletal muscle wasting is modest; most studies report limited gains~     in muscle mass and workload with highly variables outcomes from one study to another. This~     proposal was stimulated by the findings that a program of neuromuscular electrical~     stimulation resistance exercise prior to initiating functional electrical stimulation lower~     extremity cycling (FES-LEC) improves the gains in muscle mass and workload observed with FES.~     The specific objectives for the current proposal are to compare the impact of FES following~     evoking skeletal muscle hypertrophy of the lower extremity versus initiating FES cycling~     without introducing the hypertrophy effects on insulin sensitivity, control of blood sugar~     levels, oxygen uptake and amounts of muscle tissue and fat deposition. These studies could~     potentially have significant effects on thousands of people that will experience an SCI in~     the future as well as those living with SCI where prolonged paralysis is a major quality of~     life issue.~      There is a major need to investigate the mechanisms lead to maximize the benefits of FES~     applications and to understand cellular or molecular events that are associated with muscle~     hypertrophy and lead to promoting metabolic health after SCI. The designed study will provide~     a greater understanding regarding utilization of energy sources (like fats and sugars) in~     muscle~   "
69286|NCT02660060|"~     The present study was conducted to find out whether the bioavailability of 0.25 mg~     pramipexole tablets produced by PT Dexa Medica for PT Ferron Par Pharmaceuticals was~     equivalent to the reference drug (Sifrol® tablet 0.25 mg, Boehringer Ingelheim Pharma GmbH &~     Co. KG, Germany for Boehringer Ingelheim International GmbH, Germany).~   "
69287|NCT02660047|"~     Among South Asians, in comparison to Western Europeans, there is an increased risk of type 2~     diabetes mellitus (DM2) and DM2-related cardiovascular disease. The effect of Liraglutide~     (Victoza®) on cardiovascular function is therefore investigated in the DM2 patient group of~     South Asian descent specifically.~      Liraglutide is a new widely prescribed therapeutic agent for DM2 patients. It is a Glucagon~     Like Peptide - 1 homologue that improves glucose homeostasis and reduces blood pressure and~     body weight. The disadvantageous metabolic phenotype as seen in South Asians includes a~     relatively large total fat mass, with predominately visceral relative to subcutaneous adipose~     tissue and lower brown adipose tissue volume and activity, accompanied by increased lipid~     levels. The key elements in the mechanism of action of Liraglutide seem to correspond to the~     differences in metabolic profile between South Asians and Western Europeans. Diastolic~     dysfunction, an early finding of cardiovascular disease in DM2 and obesity and an independent~     predictor of mortality, has been shown to be associated with the amount of triglyceride~     accumulation in the heart and liver. The investigators hypothesize that Liraglutide has~     direct advantageous cardiovascular effects and reduces triglyceride accumulation in~     end-organs, specifically for DM2 patients of South Asian descent.~   "
69288|NCT02660034|"~     The Safety, Pharmacokinetics and Antitumor Activity of the Anti-PD-1 Monoclonal Antibody~     BGB-A317 in Combination With the PARP Inhibitor BGB-290 in Subjects With Advanced Solid~     Tumors~   "
69289|NCT02660021|"~     Orthognathic surgery or corrective jaw surgery is indicated for conditions of the jaw and~     face that are related to structure or growth malfunctioning, orthodontic problems, or~     co-morbidities associated with skeletal disfigurement.~      Imaging is crucial in the assessment and treatment planning of orthognathic surgery patients.~     Until recently, two-dimensional (2D) imaging, through cephalometry, was standard practice.~     However, it showed several limitations. The introduction of the cone-beam computed tomography~     (CBCT) enabling three-dimensional (3D) imaging has caused a paradigm shift. Though widespread~     implementation in routine practice is not yet present. Our department is one of the pioneers~     in the world of 3D virtual treatment planning for orthognathic surgery. The triple CBCT scan~     procedure has been developed in-house and implemented already in 2009.~      The investigators aim to develop a prospective database registering 3D treatment planning~     data of all consecutive patients eligible for orthognathic surgery, performed by Prof.~     Swennen. Patient demographics, detailed virtual 3D treatment planning parameters and~     orthognathic surgery data are being collected during consecutive visits within the framework~     of routine practice.~      Development of a database registering 3D virtual treatment planning data of orthognathic~     surgery, will provide more information about potential patient, virtual planning and surgical~     factors influencing postoperative accuracy of jaw correction, long-term stability of the~     jawbone, long-term condylar resorption, or soft tissue response. In general, it could provide~     answers on research questions that have been examined in prior studies on 2D-imaging, but can~     now be re-examined in case of 3D-imaging. Moreover, registration of those results could~     function as a measurement of quality of care, or could be used for sample size calculation~     for future large multicenter prospective trials.~   "
69290|NCT02660008|"~     The trial is a single-centre, randomized, double-blind, parallel trial in Group 1 and~     cross-over trial in Groups 2-4 with single doses of ZP4207 administered s.c. to hypoglycemic~     Type 1 diabetic patients to evaluate the pharmacokinetics and pharmacodynamics of ZP4207 as~     compared to marketed glucagon.~   "
69291|NCT02659995|"~     Our multicenter prospective observational study aims to show the relationship between blood~     glucose levels and glycemic variability and the development of infections during the ICU stay~     and with outcome. Within the secondary endpoints, we will evaluate if a blood glucose range~     between 70 and 140 mg/dl is associated with an increasing surviving rate in non-diabetic~     critically ill patients.~      MATERIALS AND METHODS Multicenter study (ICUs of some Italian University Hospitals). Written~     informed consent will be request before the inclusion of each patient in the study; if it~     will not be possible, an informing module will be given to the patient's family and the~     informed consent will be request to the patients as soon as possible.~      Inclusion criteria: 300 patients consecutively admitted in each ICU from January 2016 and not~     later than 31/12/2018.~      Exclusion criteria: age < 18, end-stage disease. Data collection An Excel database will be~     edited with these data about each patient: age, sex, type I or II diabetes, glycated~     hemoglobin, at-home antidiabetic therapy; admission diagnosis, admission SAPS II score; daily~     insulin administration (dose and route of administration, time of start, dose at the moment~     of glycemic measurement and min-max daily range); steroid therapy (molecule, daily dose, date~     of start and stop); antibiotic therapy (molecule, daily dose, date of start and stop); daily~     caloric and protein intake and type of nutrition; other therapies; mechanical ventilation~     (date of start and stop); blood lactates (worst daily value); daily leucocytes and~     differential white cells count; daily SOFA score; presence of infections (suspected or~     confirmed; site and microorganism and eventual Multidrug Resistance pattern); presence of~     sepsis (following SCCM criteria); length of ICU and hospital stay; outcome (ICU and hospital~     mortality).~      Every blood glucose level measurement obtained will be registered with date and time.~      Glycemic variability will be evaluated in terms of:~        -  Standard deviation (SD)~        -  Mean Amplitude of Glycemic Excursions (MAGE);~        -  Coefficient of Variation (CV);~        -  Glycemic Lability Index (GLI). STATISTICAL ANALYSIS Data analysis will be performed with~          Kolmogorov-Smirnov test; parametric and non-parametric s tests, t-test (or Mann-Whitney~          test), ROC Curve, binary logistic regression. Subgroups analysis.~      Statistical significance: p < 0,05. SAMPLE SIZE 3300 patients.~   "
69292|NCT02659982|"~     The aim of this study is to evaluate the relevance of the information as provided by the~     EarlySense Home care Tele-monitoring system can provide relevant flagging information for~     clinicians to identify the patients at higher risk to proactively assess patients' condition~   "
82522|NCT02486796|"~     This study is examine the effect of the addition of naturopathic on immunologic and/or~     inflammatory parameters and/or quality of life in women receiving neoadjuvant chemotherapy~     for breast cancer.~   "
69293|NCT02659956|"~     Background:~      Multiple sclerosis (MS) is a disease that damages the central nervous system (brain and~     spinal cord). This leads to increased physical disability over time. The disease is lifelong~     once it begins. Researchers want to learn more about MS s stages and follow them until a~     person s death.~      Objective:~      To understand how the physical and clinical signs of MS relate to its changes over time.~      Eligibility:~      Adults age 18 or older with MS or a disease of the brain and spinal cord that may act like~     MS.~      Design:~      Participants will have a medical history and a complete neurological exam. They may have~     timed tests of neurological function, such as a 25-foot walk and a 9-hole peg test.~      Participants will have multi-day visits about once a year.~      Participants will have blood drawn.~      Participants may have a brain magnetic resonance imaging (MRI) scan. They may also have an~     MRI of the spinal cord. They may get a contrast agent (dye) injected into a tube in an arm~     vein. During the MRI, participants will lie on a table that slides in and out of a metal~     cylinder.~      Participants will have the thickness of their retina measured using optical coherence~     tomography. A camera on top of a table uses lasers. Participants will look through a lens and~     follow instructions. Eye drops may be used to dilate the pupils.~      Participants will chew on a piece of sterile cotton for 1 minute to collect saliva.~      Participants agree to have an autopsy at the time of their death and to donate some of their~     organs to research, such as the brain and spinal cord.~   "
69294|NCT02659943|"~     Background:~      The immune system fights infection and can affect cancer cells. T cells are white blood cells~     that are a major part of the immune system. T cells can destroy tumors. Researchers want to~     try to manipulate the immune system to better recognize and kill tumor cells.~      Objective:~      To test the safety of giving T cells expressing a novel fully-human anti-CD19 chimeric~     antigen receptor (CAR) to people with advanced B-cell cancer.~      Eligibility:~      People ages 18 73 with a B-cell cancer that has not been controlled by other therapies.~      Design:~      Participants will be screened with:~      Physical exam~      Blood and urine tests~      Heart tests~      Bone marrow sample taken~      Scans in machines that take pictures~      Participants will have apheresis. Blood is removed through a needle in an arm. T cells are~     removed. The rest of the blood is returned through a needle in the other arm.~      The cells will be changed in a laboratory.~      Participants will get 2 chemotherapy drugs over 3 days.~      Two days later, participants will check into the hospital. They will get an intravenous (IV)~     catheter in an arm or chest vein. They will get the T cells through the IV in 1 infusion.~      After this, participants will stay in the hospital for at least 9 days and stay nearby for 2~     weeks. Then they will have blood tests and see a doctor.~      Participants will have visits 6 visits for 1 year after the infusion. Some may have more~     follow-up visits.~      Participants may samples taken of spinal fluid, bone marrow, and tumors.~   "
69295|NCT02659930|"~     Background:~      Kaposi sarcoma (KS) is a cancer most often seen in people with HIV. It causes lesions. These~     are usually on the skin but sometimes in the lymph nodes, lungs, and gastrointestinal tract.~     Researchers think a combination of drugs may help treat KS.~      Objective:~      To test a combination of the anti-cancer drugs pomalidomide (CC-4047) and liposomal~     doxorubicin (Doxil) in people with KS.~      Eligibility:~      People ages 18 and over with KS~      Design:~      Participants will be screened with:~      Medical history~      Questionnaires~      Physical exam~      Blood, urine, and heart tests~      Chest X-ray~      Biopsy: A small sample of tissue is taken from a KS lesion.~      Possible CT scan~      Possible exam of lungs or gastrointestinal tract with an endoscope: A flexible instrument~     examines~      inside the organ.~      Participants will take the drugs in 4-week cycles. They will take Doxil through an IV on Day~     1 of each cycle. They will take CC-4047 tablets by mouth each day for the first 3 weeks of~     each cycle.~      Participants will have many visits:~      Before starting treatment~      To start each cycle~      Day 15 of first 2 cycles~      Visits include repeats of screening tests and:~      Multiple blood draws~      Photographs of lesions~      Participants will keep a drug diary.~      Participants will take aspirin or other drugs to prevent blood clots.~      Participants with HIV will have combination antiretroviral therapy.~      Some participants will have a PET scan.~      Participants will continue treatment as long as they tolerate it and their KS improves. After~     treatment, they will have several follow-up visits for up to 5 years~   "
69296|NCT02659917|"~     The purpose of this randomized clinical trial was evaluate the performance of two~     conventional glass-ionomer cements in the pit and fissure sealing and atraumatic restorative~     treatment in high caries risk children.~   "
69297|NCT02659904|"~     Our primary objective in this clinical intervention study, therefore, was to explored the~     effect of residual tissue thickness on the palatal mucosa healing from baseline to 1, 3 and 6~     months after free gingival graft harvesting in order to determine as soon as possible to~     re-harvest gingival graft from same site.~   "
69298|NCT02659891|"~     The overall goal of this study is to rapidly improve clearance of BK viremia with~     Immunoglobulin (Privigen®) thereby decreasing the potential for formation of alloantibodies~     in renal transplant recipients that have had immunosuppression reduction due to BK viremia.~     Our approach is to perform a prospective, randomized, placebo controlled trial intravenous~     immune globulin (IVIg; Privigen®) plus protocolized immunosuppression reduction versus~     placebo and protocolized immunosuppression reduction in patients with BK viremia post-kidney~     transplantation.~   "
69314|NCT02659683|"~     Subjects to compare the single dose bioavailability of Torrent's Esomeprazole Magnesium DR~     Capsules 40 mg and Nexium® 40 mg DR Capsules of AstraZeneca LP, USA. Dosing periods of~     studies were separated by a washout period of 4 days.~   "
69328|NCT02659501|"~     Objectives:~        1. To evaluate the effect of liposomal bupivacaine on postoperative pain levels.~        2. To evaluate the effect of liposomal bupivacaine on postoperative opioid consumption and~          opioid related adverse events.~        3. To evaluate the effect of liposomal bupivacaine on length of hospital stay.~        4. To evaluate the effect of liposomal bupivacaine on patient satisfaction with~          postoperative pain control.~        5. To evaluate the effect of liposomal bupivacaine on overall patient satisfaction.~   "
69329|NCT02659488|"~     The purpose of this study is to explore the effect of Lisdexamfetamine on Prefrontal Brain~     Dysfunction in Binge Eating Disorder~   "
69330|NCT02659475|"~     The goal of this project is to evaluate the effectiveness and tolerability of the novel~     weight management medication PHEN/TPM ER (Qsymia®)along with nutritional and lifestyle~     modification counseling in the treatment of binge eating disorder (BED) in overweight or~     obese individuals.~   "
69299|NCT02659878|"~     Pupose:~      Takotsubo cardiomyopathy is a rare and not well-known complication of the subarachnoid~     hemorrhage.~      This form of heart failure, called as broke heart or apical ballooning syndrome, was~     first described by Japanese authors at the beginning of 1990's.~      1.5-2.2% of acute coronary syndrome is Takotsubo cardiomyopathy. Its predisposing factors,~     hypothetical parthenogenesis, diagnostic criteria and therapeutic methods are already known~     from the literature.~      The study intends to include all patients over 18 years of age who were admitted to our~     clinic within 48 hours after the bleeding regardless of gender, neurological status or age.~      Data to be registered within 24 hours after admittance:~      Instruments:~        -  Intracranial blood flow characteristics:TCCD - using Transcranial Color Doppler;~          systolic, diastolic and mean blood flow velocity, Systolic / Diastolic ratio,~          pulsatility index~        -  ECG abnormalities: Corrected QT Interval (QTc), T wave, ST segment, arrhythmia~        -  Echocardiography (Ejection fraction%, exact location and degree of cardiac wall motion~          abnormalities) - documented with video recording~      Hypothesis:~      The risk of Takotsubo cardiomyopathy (TS) is increased if SAH is associated with more severe~     state, a greater degree of bleeding, intraventricular and/ or intracerebral hemorrhage.~      The definitive care of patients is postponed due to the appearance of TS, which could affect~     the final outcome.~   "
69300|NCT02659865|"~     The main purpose of this study is to investigate the safety of the study drug known as~     LY3039478 and evaluate two different formulations of LY3039478 in healthy participants. Part~     A has three periods. Either LY3039478 or placebo will be given once by mouth in each period.~     Part B has two periods. Participants will receive both formulations of LY3039478, by mouth,~     over the course of the study. Both parts of the study will also explore how much LY3039478~     gets into the bloodstream and how long it takes the body to get rid of it. Information about~     any side effects will also be collected. Participants may only enroll in one part. The study~     will last at least 33 days, not including screening. Screening must be performed up to 30~     days before enrollment.~      Part B was added by protocol amendment approved in April, 2016.~   "
69301|NCT02659852|"~     Malignant obstructive jaundice is a common complication of advanced stage cholangiocarcinoma,~     GB cancer, and pancreatic cancer. In biliary stricture by malignancy, biliary drainage with~     placement of self-expanding metal stent (SEMS) for palliation is the therapy of choice in~     these patients. On hilar biliary malignant obstruction, bilateral stent used to be inserted.~     There are two kinds of bilateral metal stent insertion methods in hilar biliary malignant~     obstruction. (Stent in stent vs. side by side) Previously, two studies was conducted to show~     the superiority of bilateral metal stent insertion between stent in stent and side by side.~     Biliary drainage and stent patency was a little superior in side by side than stent in stent.~     But, complication related with bilateral metal stent was increased in patients with side by~     side method. Another study showed that there was no significant difference between those~     bilateral stent insertion methods. The most important concern about side by side method is~     associated with portal vein thrombosis by bilateral stent diameter. Selection of proper stent~     insertion method in patients with hilar malignant biliary obstruction is still controversial.~      The purpose of this study is to investigate the patency of stent and survival of patients in~     side by side method (6mm sized M type) compared to stent in stent method (10mm sized LCD~     type) in patient with hilar malignant biliary obstruction.~   "
69302|NCT02659839|"~     The purpose of this study is to determine 30 day mortality in cancer patients admitted to the~     intensive care unit in a resource limited setting.~   "
69303|NCT02659826|"~     A crossover trial with healthy volunteers will be conducted. Six sessions will be performed~     once a week in a counterbalanced order and at least with seven days washout period to~     minimize carry-over effects. In each session, volunteers will be submitted to quantity and~     quality of sleep, type of eating, fatigue and motivation level, cortical brain activity~     measures through paired pulse transcranial magnetic stimulation (ppTMS), spinal cord activity~     measures through electrical stimulation, non-invasive spinal stimulation (tsDCS) or~     non-invasive brain stimulation (rTMS) and physical exercise (gait training).~   "
69304|NCT02659813|"~     This study protocol is for a randomised clinical trial which aims to test two materials used~     as orthodontic archwire to compare FireWire archwires to Copper Nickel Titanium (CNiTi)~     archwires. Both professional and patient related outcome measures are to be used to fully~     evaluate performance.~   "
69305|NCT02659800|"~     This pilot, partially randomized clinical trial studies how well glycosylated recombinant~     human interleukin-7 works in increasing low cluster of differentiation (CD)4 counts after~     concurrent radiation and temozolomide treatment in patients with gliomas that tend to grow~     rapidly and spread (high-grade). Treatment with radiation and chemotherapy, such as~     temozolomide, may cause an abnormal decrease in CD4 cells, which are an important part of the~     immune system. Glycosylated recombinant human interleukin-7 may increase CD4 cell counts and~     improve survival.~   "
69306|NCT02659787|"~     This study seeks to to study the effects of buprenorphine, a partial mu-opioid agonist, on~     depressed mood in a healthy young adults with a range of depressive symptomatology.~   "
69307|NCT02659774|"~     This study has the following objectives:~        1. To examine the employers'/managerial staff's knowledge, attitudes and practices in~          promoting smoking cessation in workplace.~        2. To evaluate the smoking behaviours of participants before and after attending a smoking~          cessation intervention.~   "
69308|NCT02659761|"~     The purpose of this study is to assess the tolerability, adherence and efficacy of single~     tablet dolutegravir/abacavir/lamivudine antiretroviral therapy in people living with HIV with~     a history of injection drug use (IDU) switching from existing antiretroviral therapy (ART) or~     starting treatment after discontinuation of ART.~   "
69309|NCT02659748|"~     This study investigates the effects of bioactive fatty acids in full fat dairy (whole~     yogurt), on insulin action, calorie needs, blood lipids, immune function, and body~     composition in normal and overweight male and female volunteers.~   "
69310|NCT02659735|"~     The purpose of this study is to compare the rate and extent of absorption of JNJ-63623872~     following administration of a single dose as three different concept formulations with that~     following administration of the current formulation, under both fed and fasted conditions, in~     healthy adult participants.~   "
82523|NCT02486783|"~     Suriname is a small developing country in South America with a population of half a million~     people. Early neonatal death in Suriname is high with 16 per 1000 live births. Unpublished~     data from the Suriname Perinatal and Infant Mortality Survey estimate contribution of~     infection to early neonatal mortality at 25% (4 per 1000 live births) of all deaths. In~     comparison, incidence rates of neonatal sepsis alone are 3.5 per 1000 live births. These~     numbers indicate an increased burden of neonatal infection in Suriname versus the U.S. In any~     case about 40 newborns that die each year of infection are a huge loss, also considering the~     small Surinamese community. Despite this overall idea on the impact of infectious disease in~     Surinamese neonates exact information regarding incidence, type of infection (e.g.,~     localized, viral, early-onset or late-onset sepsis), risk factors (e.g., insufficient~     antenatal care, maternal Group B-Streptococcus status), etiology, microbial causes,~     morbidity, antibiotic treatment (type and duration), and epidemiological determinants (e.g.,~     gestational age, sex, ethnicity) are lacking.~      From a clinical perspective, there is still a challenge to identify neonates with infection.~     Neonates are often admitted with ambivalent clinical symptoms and receive preventive~     antibiotics that are costly, promote pathogen-resistance, and have negative long-term effects~     (i.e., on the development of the intestinal bacterial flora). Currently, assessment of blood~     leukocyte or trombocyte counts and levels of CRP are insufficiently sensitive to be used as~     biomarkers, while confirmation of actual sepsis or meningitis by positive culture results is~     relatively rare (0.5-3% in the United States). This complicates decisions on duration of~     antibiotic treatment and hospitalization significantly, while no other biomarkers exist.~      The circulating isoforms of adhesion molecules (cAMs), which mediate interactions of~     leukocytes with the vascular endothelium, have been proposed as biomarkers for infection and~     sepsis. During infection they accumulate in the bloodstream as a result of shedding, which~     represents their removal from cell surfaces of endothelial cells and leukocytes by enzymes~     called sheddases. Recently, we have reviewed mechanisms behind shedding of cAMs in neonatal,~     pediatric and adult sepsis. The shedding process reflects a critical and active process in~     orchestrating interaction between leukocytes and the endothelium for an effective host~     response, while minimizing collateral tissue damage. As a result, both plasma levels of cAMs~     and their sheddases are subject to change during infection and sepsis. Additionally,~     compelling, albeit limited, data suggest changes of levels of cAMs in CSF in adult and~     pediatric meningitis.~      To date, some evidence exists of changes in levels of cAMs during malaria (in children from~     Malawi) and sepsis, although not sensitive enough to predict outcomes in the clinic. Those~     levels have never been assessed simultaneously with levels of their sheddases in blood or CSF~     as a diagnostic tool. We propose that this combined approach may provide more detailed~     information about the extent of inflammatory activation in neonates.While a balance in levels~     is maintained under resting conditions or mild (local) infection, it may be perturbed during~     sepsis or meningitis . Thus, simultaneous measurement of these levels could promote early~     identification of infection, and may even distinguish between mild infection, systemic~     infection or meningitis. Currently, manufacturers are rapidly developing Luminex® technology~     as an advanced, fast, high-throughput and clinically feasible bedside tool for such an~     approach.~      We hypothesize that incidence rates of neonates with infection in Suriname are high. We~     further hypothesize that, upon signs of infection, the simultaneous measurement of cAMs and~     their SEs in serum and CSF discriminates between infected and non-infected neonates. We aim~     to: 1) identify and follow neonates at the Academic Hospital Paramaribo with signs of~     infection to establish incidence rates of infection, and 2) investigate diagnostic potential~     of our proposed biomarker combination in these neonates for infection, type of infection~     (e.g., local (mild), sepsis or meningitis) and outcomes.~   "
82524|NCT02486770|"~     This study will evaluate the safety profile and pharmacokinetic behavior of a single~     administration of Aerucin in healthy adults at three different dosages.~   "
69315|NCT02659670|"~     An investigator-blinded, prospective, 6 month study of subjects with persistent erythema~     associated with active rosacea will be conducted in 20 subjects aged 18 years and older. All~     subjects will receive standard-of-care brimonidine topical gel, 0.33% with instructions to~     apply it once daily per package insert. Adherence will be assessed using weekly internet~     surveys to document how often the medication is being used, as well as reminders about~     rosacea triggers and general use of brimonidine.~      Subjects with persistent erythema associated with rosacea will be recruited from the Wake~     Forest Baptist Health Dermatology Clinics and IRB approved advertising. At the baseline~     screening visit, subjects will have the diagnosis of rosacea confirmed by an investigator.~     Subjects will be classified as having erythematotelangiectatic or a combination~     erythematotelangiectatic and papulopustular. Study staff will evaluate whether subjects~     believe they have constant erythema or more intermittent flushing and blushing. Subjects will~     be informed of the benefits and risks of treatment. If they agree to participate, the~     subjects will give written consent approved by the Institutional Review Board and will be~     seen in follow up at 3 months and 6 months.~      Subjects will be randomized 1:1 to be in the weekly internet survey group or the standard~     care non-survey group. The internet survey will ask them how often they have used their~     medication that week, as well as giving them treatment tips and reminders about rosacea~     triggers. Subjects will be asked a variety of questions during the weekly internet survey;~     such as the amount of erythema they currently have (measured by VAS scale), how much burning~     and stinging they have, how often they have used the medication and where did they apply the~     medication, as well as any additional side effects they may be having from the medication.~      Subjects in the non-internet survey group will just get these identical surveys at the Month~     3 and Month 6 visits. The Investigator is also interested in learning through the adherence~     surveys if subjects begin using the medication on an as needed basis, and if this affects the~     side effect profile and satisfaction with the medication.~   "
69316|NCT02659657|"~     The effects of haploidentical rhG-CSF-mobilized unmanipulated blood and marrow~     transplantation (HBMT) on hematological malignancies are well established.The aim of this~     prospective cohort trial is to determine if acute graft-versus-host disease (aGVHD) could be~     decreased with IL2 therapy post HBMT.~   "
69317|NCT02659644|"~     Sickle cell disease is a genetic red blood cell disorder that can result in blocking of the~     small blood vessels from sickle shaped red blood cells. This causes pain, the main feature of~     sickle cell disease. Also, low amounts of nitric oxide can occur in sickle cell disease, a~     substance important for widening the blood vessel wall and therefore preventing blockage of~     the small blood vessels.~      Citrulline is a drug that is known to increase nitric oxide. This is a phase I study of~     citrulline given by mouth to evaluate the safety, tolerability and appropriate dosing of this~     medication for individuals with sickle cell disease.~   "
69318|NCT02659631|"~     The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses~     of PF-06671008 in patients with advanced solid tumors with the potential to have P-cadherin~     expression. The study will then expand to look at the selected dose in patients with~     P-cadherin expressing TNBC, CRC or NSCLC.~   "
69319|NCT02659618|"~     The goal of this study is to identify a serum biomarker(s) that can detect increased levels~     of a population of CD15+ hypodense neutrophils termed low-density granulocytes (LDG) in the~     blood of patients with severe persistent asthma.~   "
69320|NCT02659605|"~     The purpose of this study is to determine if delayed cord clamping above the perineum has an~     effect on neonatal hematocrit when compared to delayed cord clamping below the perineum in~     pre-term spontaneous vaginal deliveries.~   "
69321|NCT02659592|"~     Design: prospective cohort study. Setting: Tertiary university-affiliated ART and oncology~     centers. Patients: 20 cancer survivors who underwent ovarian transplantation of frozen-thawed~     ovarian tissue, with the aim to conceive.~      Interventions: Ovarian tissue cryopreservation (OTCP) and transplantation, endocrine~     monitoring, IVF.~   "
69322|NCT02659579|"~     The investigators will evaluate the effectiveness of a parent-child shared reading~     intervention run by The Reader Organisation. The investigators will be asking parents and~     children across Liverpool to either (i) attend a weekly shared reading programme or (b) to~     attend a weekly children's reading group at a library. The investigators will look at how the~     reading groups affect children's language development, by comparing children's language~     development before having gone to these groups and after they have attended these groups.~   "
69323|NCT02659566|"~     Background:~      Malaria is a disease that affects many people in the country of Mali and other parts of~     Africa. It is caused by germs that are spread by mosquito bites. Malaria may be mild, but can~     also be serious or can lead to death if not diagnosed and treated promptly. Children younger~     than 5 years and pregnant women are at highest risk of malaria. Researchers want to better~     understand how malaria infection suppresses the immune system. They want to compare a group~     of adults who receive antimalarial treatment to a group that does not receive it.~      Objective:~      To investigate the effect of antimalarial treatment at the beginning of the dry season on the~     immune system and malaria episodes.~      Eligibility:~      Healthy adults ages 18-60 who live in the area of Doneguebougou, Mali.~      Design:~      Participants will be screened with a physical exam and health questions.~      If participants are found to be sick at the screening visit, they will get initial care at~     the study clinic free of charge. They may get referrals for consultation.~      Participants will be randomly assigned to a group. One group will get an approved~     antimalarial drug called Coartem . The other will not receive it.~      Participants in the Coartem group will take the drug for 3 days.~      All participants will have blood tests.~      Al participants will be seen about once a month for about 1 year. At each visit, they will be~     asked how they are feeling and be examined. Blood will be drawn.~      If participants become sick at any time, they will come to the clinic to be examined.~   "
69324|NCT02659553|"~     1. Clinical impact of graft steatosis on postoperative complications after OLT.~        2. Recommendations to improve outcomes after transplantation of steatotic livers and~          increase donor pool.~   "
69325|NCT02659540|"~     This is an open-label, multicenter pilot Phase 1 study of the checkpoint antibodies~     ipilimumab and nivolumab in combination with radiotherapy (RT) in 18 subjects with~     unresectable stage IV melanoma. All subjects will receive concurrent ipilimumab (3 mg/kg) and~     nivolumab (1 mg/kg) every 3 weeks for 4 doses, followed by nivolumab monotherapy (240 mg)~     every 2 weeks. Radiotherapy will be initiated after the first dose and before the second dose~     of immunotherapy.~   "
69326|NCT02659527|"~     This diagnostic clinical trial will be conducted according to a randomized, prospective,~     controlled, double-arm, single-centre design. The control will be implemented by comparing~     the PET/MRI results with the histopathological finding after radical prostatectomy (positive~     state), the assumed absence of a relevant prostate cancer focus if PET/MRI guided biopsy and~     standard biopsy are negative (negative state) and/or the detection of a biochemical tumor~     relapse (rising PSA after PSA nadir; secondary objective).~   "
69327|NCT02659514|"~     The purpose of this study is to evaluate the efficacy and tolerability of poziotinib in~     patients with HER2-positive metastatic breast cancer who have received at least 2 prior~     HER2-directed treatment regimens.~   "
69333|NCT02659436|"~     The purpose of this pilot study is to explore whether there is a differential impact of~     verbal versus imagery-based cognitive behavioural therapy (CBT) as a treatment augmentation~     strategy for individuals with social anxiety disorder (SAD). Clients who have not~     demonstrated clinically significant change following group CBT for SAD will receive four~     additional sessions of either verbal-based CBT or imagery-based CBT. We hypothesize that that~     individuals who receive imagery-based CBT will experience even stronger improvements and be~     more satisfied with their treatment than individuals who received traditional~     verbal-linguistic CBT.~   "
69334|NCT02659423|"~     Bystander interventions, recognized as promising violence prevention strategies, are unique~     in their engagement of all community members to 1) recognize situations that may become~     violent and 2) learn to safely and effectively intervene to reduce violence risk. Based on~     their promise, the Campus Sexual Violence Elimination Act (SaVE) now requires all~     publicly-funded colleges to provide bystander intervention. With SaVE's policy intervention~     requiring bystander interventions, a natural experiment has arisen to determine the~     relative efficacy of students' bystander training across multiple colleges. Investigators~     propose a quasi-experimental design (using fractional factorials) to evaluate the relative~     efficacy of three bystander interventions to reduce violence in college communities. Green~     Dot will be one of three bystander interventions evaluated. A recent rigorous evaluation has~     found that Green Dot is associated with a 20-40% reduction in VAW in college and high school~     settings.~      In aim 1, investigators will compare the relative efficacy of bystander interventions to a)~     increase bystander efficacy and behaviors, b) reduce violence acceptance, c) reduce~     interpersonal violence victimization and perpetration, and d) increase program cost~     effectiveness. The three main bystander groups compared will be: exclusively online training,~     Green Dot (speeches and intensive bystander training), and other skills-based bystander~     training. Program efficacy data will be obtained from student surveys, campus crime~     statistics, and surveys with college staff and administrators responsible for selecting and~     implementing bystander interventions.~      In aim 2, investigators seek to grow communities of VAW prevention researchers. Researcher~     communities will form through researchers' engagement with college recruitment, survey~     design, data collection and analyses. Specifically investigators will determine the efficacy~     of this program to increase VAW prevention research productivity defined as a) increasing~     research skills and b) increasing research communications measured as manuscript submissions,~     presentations, and publications.~      This natural experiment will generate new understanding into efficacy of how bystander~     programs work. This natural experiment will also provide the VAW research community an~     opportunity to increase our skill-sets and share our experiences with and help grow the next~     generation of VAW prevention researchers.~   "
69335|NCT02659410|"~     In Quebec, thousands of workers are concomitantly exposed to heat and chemical compounds.~     Exposure to heat induces physiological responses that help maintaining a stable body~     temperature. Those changes can affect organ functions implicated in absorption and~     metabolism. According to literature, those changes could lead to increased concentrations of~     chemical compounds in the body and their toxicity. Therefore, the aim of this study is to~     evaluate the pulmonary absorption and toxicokinetics of 3 organic solvents in heat stress~     conditions in volunteers exposed in a inhalation chamber. Results will then be used to~     develop PBPK models that will allow to predict organic solvent kinetics when coexposed with~     heat.~   "
69336|NCT02659397|"~     The purpose of this research study is to measure the amount of atorvastatin and ETC-1002 in~     the blood, to determine how ETC-1002 affects the level of LDL-cholesterol (bad cholesterol)~     and other markers of health and disease in blood and urine, and to see how ETC-1002 is~     tolerated in the body compared to placebo when added to stable atorvastatin 80 mg background~     therapy in statin-treated patients.~   "
69337|NCT02659384|"~     This is a randomized phase II study, aimed at evaluating the efficacy (through progression~     free survival at 6 months) and safety of 5 different treatments involving atezolizumab,~     bevacizumab and/or acetylsalicylic acid in advanced recurrent platinum-resistant ovarian~     cancer patients in order to select the optimal treatments for further development in Phase~     III.~   "
69338|NCT02659371|"~     Due to a higher risk of complications, obese and overweight patients with macromastia are in~     Denmark prohibited mammoplasty , as BMI must be within normal range, i.e. BMI < 25 kg/m2.~      The study is a pilot study with a diet intervention group and no control group. The~     intervention is a 12 week low energy diet pre-operative weight loss program investigating if~     this will result in weight loss making the overweight and obese patients eligible for breast~     reduction surgery i.e. BMI < 25.~   "
69339|NCT02659358|"~     The purpose of this study is to evaluate the association between wearable biosensor data,~     performance status and patient-reported outcomes in cancer patients. Participants in this~     study will wear a biosensor (Fitbit Charge HR®) for 15 days and respond to questionnaires~     that will assess patient reported outcome measures including physical function, emotional~     distress, pain interference, sleep disturbance and fatigue.~      Eligible patients will have a diagnosis of advanced cancer. Patients must be greater than 18~     years of age and be English speaking due to the questionnaires that will be administered~     during the study. Patients must also be ambulatory (use of walking aids, such as cane and~     rollator, is acceptable) and have access to a smartphone with internet access (IOS or~     Android). It is also necessary for patients to have scheduled oncology clinic visits at least~     once every 2 weeks.~   "
69340|NCT02659345|"~     Participants in this research study are asked to tell about their experience with art~     therapy. Participants in this research study are currently receiving chemotherapy treatment~     for cancer. The purpose of this study is to learn how art therapy affects mood, anxiety,~     pain, and emotions of individuals with cancer who are undergoing chemotherapy.~   "
69341|NCT02659332|"~     -  Primary Objective: To show that small pTa bladder tumors can be removed with diode laser~          in an outpatient department.~        -  Secondary Objective: To evaluate the patients' symptoms during and after the laser~          TURBT.~        -  Tertiary Objective: To evaluate the rate of remnant tumor tissue one month after the~          laser TURBT.~   "
69342|NCT02659319|"~     The purpose of the study is to test the effectiveness of a child obesity intervention with~     multiple components targeting nutrition and/or psycho-social factors in children, their~     parents, and their classmates. The specific aims of the study are to (1) Determine the~     effectiveness of two family-level interventions for improving child outcomes (unhealthy~     eating, low activity, and overweight); (2) Determine the extent to which adding a family~     dynamics component enhances the effectiveness of a family lifestyle intervention and improves~     the child outcomes listed above; and (3) Determine the extent to which a peer-level~     intervention improves the effectiveness of two family-level interventions among overweight~     children.~   "
69368|NCT02658981|"~     This phase I trial studies the safety and best dose of anti-LAG-3 (anti-LAG-3 monoclonal~     antibody BMS-986016) or urelumab alone and in combination with nivolumab in treating patients~     with glioblastoma that has returned (recurrent). Anti-LAG-3 monoclonal antibody BMS-986016,~     urelumab, and nivolumab are antibodies (a type of protein) that may stimulate the cells in~     the immune system to attack tumor cells. It is not yet known whether anti-LAG-3 monoclonal~     antibody BMS-986016 or urelumab alone or in combination with nivolumab may kill more tumor~     cells.~   "
69343|NCT02659306|"~     Anti-HIV drugs cut down the number of serious infections that people with HIV get. However,~     some subjects taking anti-HIV drugs do not achieve adequate cluster of differentiation 4~     (CD4) recovery and decrease in elevated cluster of differentiation 8 (CD8) cells. Such~     patients with a low CD4/CD8 ratio remain at risk for developing acquired immune deficiency~     syndrome (AIDS) and non-AIDS-related complications. Two of the most important factors~     associated with low CD4/CD8 ratio include: the persistence of HIV on ART and inflammation.~      Metformin, the most widely used medication to treat type 2 diabetes, is well tolerated with~     minimal side effects. It has been linked to anti-aging and weight reducing properties in~     non-diabetic persons. Because of its ability to improve immune functions, metformin could be~     a promising addition to ART in HIV patients. It is also reported to change the composition of~     microbes in the gut which may improve inflammation.~      PURPOSES OF THE STUDY~      The purposes of this study are to find out if:~        1. metformin can be combined with anti-HIV drugs to reduce the amount of hidden virus in~          the body;~        2. metformin can be combined with anti-HIV drugs to improve immune function.~        3. metformin can be combined with anti-HIV drugs to impact CD4 T cell count and CD4/CD8 T~          cell ratio during treatment and after its discontinuation~        4. metformin can change the composition of the bacteria in the gut which may improve~          inflammation.~      For this purpose, the investigators will add metformin at the usual antidiabetic dose for 12~     weeks for patients receiving stable ART, having a CD4/CD8 ratio below 0.7.~      Approximately 22 participants will be enrolled in this study at the Chronic Viral Illness~     Service of the McGill University Health Centre, the Ottawa Hospital and the Maple Leaf~     Medical Clinic (Toronto). This study will last about 24 weeks; metformin treatment will be~     for 12 weeks. In order to be eligible for the study, the participants must be 18 years of age~     or older, have an undetectable viral load (the quantity of the HIV virus in the blood must be~     less than 50 copies/ml) for at least 3 months and have a CD4/CD8 ratio of less than 0.7. All~     participants will also be asked to give blood and stool samples and optional colon mucosal~     biopsy samples (before and after metformin supplementation) to study the size of the viral~     reservoir and the amount of T cell activation and changes in gut microbiota composition.~   "
69344|NCT02659293|"~     This is a Phase 3 randomized trial of carfilzomib, lenalidomide, dexamethasone versus~     lenalidomide alone after stem-cell transplant for multiple myeloma, eligible to subjects who~     completed autologous stem cell transplant for symptomatic myeloma who are considered for~     lenalidomide maintenance.~   "
69345|NCT02659280|"~     This study will take about 3-16 months. Participants will be inpatients in the Hennepin~     Health System that are transitioning into outpatient or home health Physical Therapy or~     current outpatient patients. Investigators will assess 24 participants for eligibility based~     on the study's inclusion criteria. If eligible, Investigators will attain informed consent~     and provide instruction on how to use a coaching app, Hudl Technique, and enter data in the~     Apple Health Kit (all participants will be gifted an iPad mini 4, cover and Hudl Technique~     app). Baseline Body Mass Index (BMI) will be taken and entered in the Apple Health Kit.~     Randomization (1:1) will occur by an outside statistician. 12 patients will be allotted to~     the control group (receive traditional Outpatient PT and have access to the Apple Health Kit~     and Hudl Technique with the gifted iPad). 12 patients will be the variable group (receive~     traditional Outpatient PT, have access to the Apple Health Kit and Hudl Technique with the~     gifted iPad, and have an adjunct Home Exercise Program which will be administered via~     tele-health store and forward technology 1x/wk). There will be an 8 week assessment in~     which investigators plan to measure 1) satisfaction with PT (via survey) 2) Home Exercise~     Program (HEP) compliance (via survey) 3) incidents of ED visits or hospital admissions 4) BMI~     (via patient report with option to put it in the Apple Health Kit). There will be a 24 week~     assessment in which investigators will measure the same 4 measurements. Investigators plan on~     performing this protocol for an additional 24 participants in late 2016/early 2017 (48~     participants in total). Unfortunately, this will be a non-blinded (assessor, therapist and~     participant) study due to the nature of the intervention and how investigators received the~     funding. Casey Byron will be the Principal Investigator. Investigators would like the~     statistician to be blinded to group allocation until completion of the study (roughly~     3/11/2017).~   "
69346|NCT02659267|"~     The study aims to verify if the VAMOS strategy contributes to an increase in physical~     activity and healthy eating habits among users of the Health Academy Program from Belo~     Horizonte, Minas Gerais.~   "
69347|NCT02659254|"~     This study is a small scale pilot trial for Sirolimus Target Eluting Bioresorbable Vascular~     Scaffold (Firesorb) in Patients with Coronary Artery Disease for the first time. The goal is~     to access the preliminary safety and efficacy of Firesorb implantation in the human body, and~     to provide evidence for subsequent large-scale, multi-center, randomized controlled clinical~     trials. Then provide the basis for the formal application of the product in China.~   "
69348|NCT02659241|"~     The goal of this clinical research study is to learn if certain characteristics of DNA (the~     genetic material in cells) affects how ovarian, fallopian tube, or primary peritoneal~     carcinomas respond to therapy with AZD1775. Researchers also want to learn if treatment with~     AZD1775 affects the DNA in cancer cells.~   "
69349|NCT02659228|"~     In this study, the investigators explore anesthesia as a tool for providing further insight~     into the level of consciousness of individuals with a clinical diagnosis of unresponsive~     wakefulness syndrome (UWS), but who possess some neurophysiological signatures of conscious~     awareness. This group, who could potentially be conscious, will herein be referred to as the~     target population. Our goal is to assess whether or not neurological patterns of~     consciousness in the target population respond to anesthesia in a similar manner to~     neurologically compromised individuals with known consciousness (e.g. those in minimally~     conscious state (MCS). In healthy controls, propofol-induced unconsciousness results in an~     elimination of the mismatch negativity event-related brain potential (ERP) and a diminished~     directed connectivity. The investigators hypothesize that at doses well below those required~     for surgery, anesthesia will have similar effects on these neural patterns in neurologically~     compromised patients with the potential for conscious awareness, but will not affect these~     patterns in those who lack consciousness.~   "
69350|NCT02659215|"~     The purpose of this study is to evaluate the safety and efficacy of Hyalofast® scaffold with~     bone marrow aspirate concentrate (BMAC) compared to microfracture in the treatment of~     symptomatic cartilage defects of the knee.~   "
69351|NCT02659202|"~     The purpose of this proposal is to determine whether epidural spinal cord stimulation can~     modulate cardiovascular control during exercise in Heart Failure patients.~   "
69352|NCT02659189|"~     The purpose of this study is to create an institutional registry of Chronic Obstructive~     Pulmonary disease through a prospective survey based on epidemiological data, risk factors,~     diagnosis, prognosis, treatment, monitoring and survival.~   "
69353|NCT02659176|"~     Comparison between transperineal repair of rectocele with or without posterior internal~     sphincterotomy.~   "
69354|NCT02659163|"~     The high prevalence and burden of cardiometabolic disease underlie the urgent need to~     identify novel approaches to managing and preventing cardiometabolic disease and risk. This~     project will test an innovative use of mobile health technology to implement a closed-loop~     feedback system that collects objective patient-generated data and provides clinical~     recommendations to modify contributing health behaviors. In addition to improving care for~     cardiometabolic disease, the tools and methods developed by this study for collecting patient~     data and providing clinical feedback could also easily be adapted and applied to a range of~     other health conditions, and are thus highly relevant to public health.~   "
69387|NCT02658734|"~     This is a Phase IV, single-arm, multicenter, open-label clinical trial designed to assess the~     safety of trastuzumab emtansine in Indian patients with HER2-positive unresectable locally~     advanced breast cancer (LABC) or metastatic breast cancer (mBC) who have received prior~     treatment with trastuzumab and a taxane.~   "
69356|NCT02659137|"~     TAVI induced LBBB is a complication that occurs between 7 and 65 % of the cases, numbers that~     differ considerably between devices. There is an increased risk of progression to total~     AV‐block at follow‐up, with the risk of brady‐arrhythmic death.~      The aim of the study is to elucidate the anatomical location of the conduction pathology of a~     TAVI induced LBBB. This could impact valve design and placement and thereby reduce the number~     of new LBBB induced by TAVI in the future. Furthermore, finding predictors for progression to~     a high degree AV block in the follow‐up (and thus an indication for permanent pacemaker)~     could improve management of post‐operative conduction abnormalities and prevent the risk of~     brady‐arrhythmic death.~   "
69357|NCT02659124|"~     This is a comparison trial with novel application of AmnioFix and a control arm. Patients~     electively being treated with facial lasers will be assigned to receive AmnioFix in addition~     to the normal standard of care placed on half of their face after laser procedure, and normal~     post laser standard of care alone on the other half of their face. The investigators will~     investigate the end points of healing, recovery time, re-epitheliaziation, and other cosmetic~     factors. The study is designed to compare AmnioFix to the current standard of laser care.~   "
69358|NCT02659111|"~     Patients with idiopathic Normal Pressure Hydrocephalus (iNPH) have variable difficulties~     regarding gait, balance, cognition and micturition. A shunt operation will improve these~     difficulties in most cases. Data suggest however, that they do not change their physical~     activity postoperatively. Physical training has been shown to be beneficial in patients with~     similar diseases i.e. Parkinson. The aim of this study is to apply a high intensity physical~     training program after a shunt operation to see if the patients can improve their physical~     capacity and ambulatory activity more than patients who only receive standardized written~     advice about physical training.~   "
69359|NCT02659098|"~     The purpose of this study is to evaluate the safety and performance profile of the~     suprachoroidal surgical approach and the Delivery System.~   "
69360|NCT02659085|"~     Developing more effective and faster acting antidepressant is of outmost clinical importance.~     Available antidepressant therapies have a delayed therapeutic effect. It typically takes~     several weeks before symptom relief is evident. Furthermore, antidepressants are relatively~     ineffective - as many as 30% of patients do not respond to any medication at all. In this~     study the investigators evaluate the NMDA-receptor antagonist ketamine as a potentially new~     antidepressant treatment for severely depressed patients and compare its effectiveness with~     that of electroconvulsive therapy (ECT).~   "
69361|NCT02659072|"~     Multicenter observational survey of the presence of Human Papilloma Virus (HPV) on trans~     vaginal ultrasound (TVUS) probes, and of the behavior of professionals during US examination~     and probe disinfection. This will allow modeling the risk of HPV transmission, and could~     contribute establishing future guidelines for reducing the risk of transmission of~     microorganisms and the risk of infection through TVS.~   "
69362|NCT02659059|"~     The purpose of part 1 of this study is to determine the objective response rate (ORR) in~     stage IV NSCLC subjects treated with nivolumab in combination with ipilimumab as first line~     therapy.~      The purpose of part 2 of this study is to determine the safety and tolerability of nivolumab~     and ipilimumab combined with a short course of chemotherapy in first line stage IV NSCLC.~   "
69363|NCT02659046|"~     The aim of the study is to measure the effect of Finnish physician-staffed EMS unit treatment~     methods on traumatic brain injury (TBI) patient prognosis.~      In the second part of the study the gathered data will be combined with the data from an~     earlier study (NCT01454648) for regression analysis. The aim of the second study is to~     identify prehospital factors influencing the prognosis of prehospital TBI patients.~   "
69364|NCT02659033|"~     CEREMI is an open, randomised prospective study in parallel groups in healthy volunteers.~     This study compare the effect of a monotherapy by ceftriaxone or cefotaxime on the emergence~     of resistance of enterobacteria to 3rd-generation cephalosporins within the intestinal~     microbiota. Each volunteer will be treated for 3 days by either ceftriaxone (1 gram per day)~     or cefotaxime (1 gram every 8 hours).~   "
69365|NCT02659020|"~     The main purpose of this study is to evaluate the safety and efficacy of two anti-cancer~     drugs (gemcitabine and docetaxel) with and without the study drug known as olaratumab in~     participants with advanced soft tissue sarcoma (STS) or STS that has spread to another~     part(s) of the body.~   "
69366|NCT02659007|"~     The long-term goal is to identify and establish effective mind-body interventions (as an~     aspect of complementary and alternative medicine) to improve health and Quality of Life (QoL)~     for people with disabilities. Preliminary data suggest that engagement in yoga is feasible~     and beneficial for multiple study populations, and it may relieve symptoms of neuropathy. The~     central hypothesis is that individuals who complete yoga will have significantly better~     balance, mobility, and QoL after 8 weeks of yoga.~   "
69367|NCT02658994|"~     Background~      The negative effects of perinatal depression on mother and child start early and persist~     throughout the life-course. Given that 10-35% of children worldwide are exposed to perinatal~     depression in their first year of life, 16 mitigating this intergenerational risk is a global~     public health priority. However, there is a dearth of studies on whether a maternal~     depression intervention can have long-term benefits for either the mother or her child. This~     is a study of the effectiveness of an extended 36-month peer-delivered depression~     intervention, the Thinking Healthy Programme PLUS (THPP+) for women and their children in~     rural Pakistan.~      Study Design~      The THPP+ study aims to evaluate the effects of an extended 36-month perinatal depression~     intervention on mother and child outcomes using a cluster randomized controlled trial (c-RCT)~     design. The trial will recruit 560 pregnant women who screened positive for perinatal~     depression (PHQ-9 >=10) from 40 village clusters, of which 20 clusters will receive the THPP+~     intervention delivered by trained peers. These women will have already been participating in~     the trial of the shorter, 6 month long, version of the intervention. Women in the THPP+~     intervention arm will receive bimonthly group-based sessions. Primary outcomes are 3-year~     maternal depression and 3-year child socio-emotional and cognitive development. All primary~     analyses will be intention-to-treat and will account for the clustered study design.~      Discussion~      This trial has the potential to further significantly our understanding of whether~     intervening on women's perinatal depression can mitigate the negative effects of maternal~     depression on 36-month child development.~   "
69369|NCT02658968|"~     This study is a phase 1, dose finding, open-label study in patients with relapsed/refractory~     diffuse large B-cell lymphoma (DLBCL). This is a dose escalating study to define the maximum~     tolerable dose of lutetium (177Lu)-lilotomab satetraxetan (Betalutin®) in DLBCL patients who~     are not eligible for autologous stem cell transplant. The study will also assess safety and~     toxicity, pharmacokinetics, biodistribution and efficacy.~   "
69370|NCT02658955|"~     Implementing guidelines of EHS for abdominal wall closure in all specialities of a General~     Hospital. Migrating from large stitch technique to short stitch technique.~   "
69371|NCT02658942|"~     to assess safety, efficacy of Flexible ureteroscopy (FURS) holmium:YAG laser lithotripsy (LL)~     compared to extracorporeal shockwave lithotripsy (ESWL) in management of lower calyceal~     stones (LC) stones.~   "
69372|NCT02658929|"~     Study CRB-401 is a 2-part, non-randomized, open label, multi-site Phase 1 study of bb2121 in~     adults with relapsed/refractory multiple myeloma (MM).~   "
69373|NCT02658916|"~     The purpose of this study is to evaluate the long-term safety and tolerability of multiple~     intravenous (IV) infusions of BIIB092 in participants with Progressive Supranuclear Palsy~     (PSP). The study will also assess the pharmacodynamic (PD) effects of BIIB092 on~     cerebrospinal fluid (CSF) extracellular tau (eTau), pharmacokinetics (PK), and immunogenicity~     of BIIB092 in participants with PSP.~   "
69374|NCT02658903|"~     The safety and efficacy of a urinary catheter designed to prevent catheter associated urinary~     infections is studied.~   "
69375|NCT02658890|"~     The purpose of the study is to determine safety and effectiveness of experimental medication~     BMS-986205 when combined with Nivolumab and in combination with both Nivolumab and Ipilimumab~     in patients with cancers that are advanced or have spread. Pharmacokinetics and~     pharmacodynamics of BMS-986205 when combined with Nivolumab and in combination with Nivolumab~     and Ipilimumab in this patient population will also be assessed.~   "
69376|NCT02658877|"~     The primary purpose of this study is to identify additional mechanisms of action of~     omalizumab that will lead to improved stratification of patients for treatment. Understanding~     the response of specific innate immune effector cells in the lung can provide clues to these~     questions. Investigators will use non-invasive measures of a discrete cell population to~     examine the downstream effects of omalizumab treatment in the lung. Information derived from~     these studies will help clarify mechanisms of action of omalizumab and help identify~     potential tools for patient endotyping and stratification for therapeutic interventions.~   "
69377|NCT02658864|"~     This study was to evaluate the pharmacokinetics of single and multiple doses of oral~     lafutidine tablets and the effect of food on pharmacokinetics in healthy Chinese subjects.~     The tolerability and the effect of sex on the pharmacokinetic properties were also evaluated~     to acquire more pharmacokinetic information.~   "
69378|NCT02658851|"~     This study protocol will evaluate the efficacy of Bovie Medical's J-Plasma® helium based~     plasma technology in the reduction of lymphoceles following pelvic lymph node dissection~     (PLND) during robotic assisted radical prostatectomy (RARP). The J-Plasma® handpiece will be~     used during the PLND by dissecting the lymph nodes and sealing the lymphatic channels to~     prevent lymph leakage.~   "
69379|NCT02658838|"~     The purpose of this study is to determine ticagrelor combining with low molecular weight~     heparin is effective and safe during PCI or not.~   "
69380|NCT02658825|"~     The purpose of this study is to evaluate the effect of JNJ-63623872 on the QT/QTc interval at~     supratherapeutic exposure in healthy participants (Panel 2).~   "
69381|NCT02658812|"~     The goal of this clinical research study is to learn if talimogene laherparepvec can help to~     control recurrent (has come back after treatment) breast cancer. The safety of this drug will~     also be studied.~      This is an investigational study. Talimogene laherparepvec (T-VEC) is FDA approved and~     commercially available for the treatment of melanoma. It is considered investigational to use~     T-VEC to treat breast cancer. The study doctor can explain how the study drug is designed to~     work.~      Up to 35 participants will be enrolled in this study. All will take part at MD Anderson.~   "
69382|NCT02658799|"~     Non-steroidal anti-inflammatory drugs (NSAIDs) are widely used for inflammation control and~     pain relief. However, while adjunct use of NSAIDs is avoided for periodontal therapy because~     of related side effects, cyclic administration of NSAIDs may reduce or eliminate these~     effects. The investigators evaluated the effect of a cyclic diclofenac potassium regimen on~     clinical parameters and levels of prostaglandin E2 (PGE2) and interleukin-1beta (IL-1beta) in~     the gingival crevicular fluid (GCF) of subjects with periodontitis. Forty-one subjects with~     moderate to chronic periodontitis (33 men, 8 women) were divided into two groups (test and~     control) after initial periodontal therapy. During this 6-month, randomized, double-blind,~     placebo-controlled study, test (n = 28) and control (n = 13) groups were administered a~     cyclic regimen of diclofenac potassium (50 mg, twice daily) or placebo. Clinical measurements~     of disease severity and GCF sample collections were made at baseline, 2, 4 and 6 months. GCF~     levels of PGE2 and IL1-1beta were determined using EIA and ELISA kits, respectively.~   "
69383|NCT02658786|"~     Chronic liver diseases of differing etiologies are among the leading causes of morbidity and~     mortality worldwide [1]. Chronic liver disease progresses through different pathological~     stages that vary from mild hepatic inflammation without fibrosis to advanced hepatic fibrosis~     and cirrhosis [2]. Assessment of the stage of liver disease is important for diagnosis,~     treatment, and follow-up both during treatment and after cessation of treatment. A liver~     biopsy is the oldest and most accurate method used to evaluate liver histology and the~     progression of chronic liver disease. Furthermore, different histological scoring systems~     have been developed and modified [3]. A liver biopsy is considered the gold standard for~     assessing liver histology [4]. During the pathological progression of liver fibrosis,~     excessive amounts of extracellular matrix build up; furthermore, serum levels of various~     biomarkers change, in addition to the appearance of new biomarkers in the serum during the~     different stages of fibrosis [2, 5]. Recently many noninvasive markers (NIMs) for assessing~     liver fibrosis have been developed, and they are frequently used in clinical practice. They~     have been validated in different studies, and some were found to be highly accurate in the~     assessment of liver fibrosis compared with liver biopsies [6-7], which have always been used~     as the standard reference method for evaluating the accuracy of noninvasive methods. There~     are limited studies documenting the cost effectiveness of non invasive markers over invasive~     technique.~      Most people with chronic Hepatitis B or C are unaware of their infection, putting them at~     serious risk of developing cirrhosis or liver cancer which are life threatening. Similarly~     patients with non alcoholic fatty liver diseases are unaware about fibrosis in liver. About~     20-50% of persistent infection ends up into fibrosis and finally cirrhosis. Invasive and non~     invasive diagnostic methods are widely used to detect the fibrosis. Clinicians use different~     drugs and combinations to treat HBV and HCV infections. However, there is scarcity of a~     longitudinal prospective study to assess the cost effectiveness of these diagnostic measures.~      We planned to conduct a retrospective followed by prospective cohort study among all cases~     that underwent biopsy in ILBS or GB Pant Hospital since 2000 till Dec 2020 with HBV~     infection, HCV infection, or non alcoholic fatty liver disease. For retrospective cohort~     study, we will collect data from hospital information system for all patients with HBV~     infection, HCV infection, or non alcoholic fatty liver disease, who underwent biopsy during~     the period of 2000-Dec 2015. The new patients with HBV infection, HCV infection, or non~     alcoholic fatty liver disease who will undergo biopsy during the period Jan 2016- Dec 2020~     will serve as a cohort for prospective design.~      We will collect socio-demographic data, clinical data, family history, personal history,~     medical history, anthropometry, biochemical and radiological data from each patient. We will~     also be conducting a cost effective analysis for various non invasive markers against biopsy~     as a gold standard in predicting fibrosis, both for retrospective and prospective cohorts.~      For prospective cohort study, after evaluation of baseline biopsy results, the cases with~     metavir fibrosis score (F0-3) will be followed for a period of 5 years to document incidence~     of development and progression of fibrosis.~      No additional investigation or test will be asked to the patient for the study. We will also~     develop a predicting model for development and progression of fibrosis.~   "
69384|NCT02658773|"~     The purpose of the investigators' study was to evaluate whether cervical lidocaine-Prilocaine~     cream will improve pain scores compared to placebo. The investigators hypothesized that~     lidocaine-Prilocaine cream will reduce the insertion pain.~   "
69385|NCT02658760|"~     Few studies have reported the efficacy of adding dexmedetomidine to bupivacain for fascia~     illiaca compartment black. Comparison of dexmedetomidine and bupivacaine with bupivacaine~     alone on the quality of ultrasonography guided fascia iliaca compartment block in adults~     undergoing femur fracture fixation surgery at 2014.~   "
69386|NCT02658747|"~     This is a multi-center retrospective observational research study collecting data for~     participants initiated on docetaxel for the treatment of relapsed non-small cell lung cancer~     (NSCLC) up to 6 years before start of data collection and who have completed/stopped~     docetaxel treatment at least 30 days prior to data collection. The primary goal of this study~     is to describe the percentage of participants with at least one neutropenic sepsis (NS)~     episode following initiation of treatment with single-agent docetaxel. Data will be collected~     until end of docetaxel treatment plus an additional 30 days to allow for presentation with~     toxicity.~   "
84013|NCT02467335|"~     A single oral dose study in subjects with hepatic impairment and healthy control subjects.~     Subjects will stay at the clinical facility where interval blood samplings will be obtained~     and examined for drug effect.~   "
69388|NCT02658721|"~     Intravenous regional anesthesia (IVRA) is used in outpatient hand surgery as an easily~     applicable and cost-effective technique with clinical advantages. Nevertheless, IVRA has some~     disadvantages including anesthetic toxicity, slow-onset, poor muscle relaxation, tourniquet~     pain, and minimal postoperative pain relief. Providing an ideal anesthesia by overcoming~     these disadvantages is possible with the addition of some adjunct agents into local~     anesthetic substances. One of these adjunct agents used for IVRA is tramadol, a synthetic~     analgesic having opioid and nonopioid characteristics. The present study aimed to investigate~     the effects of addition of systemic tramadol or adjunct tramadol to lidocaine for IVRA in~     patients undergoing hand surgery..~   "
69389|NCT02658708|"~     This proposed study will examine feasibility and implement therapeutic bright light that is~     tailored to the individual's circadian typology to estimate its therapeutic effects on~     sleep/wake patterns and fatigue in breast cancer patients undergoing chemotherapy.~   "
69390|NCT02658695|"~     The aim of this work is to assess the effect of air bubbles localization inside the uterus on~     embryo transfer outcome in ICSI cycles.~      Is there a relationship between embryo transfer outcome and the distance between fundal~     endometrial surface and air bubbles assessed by trans-abdominal ultrasound?~   "
69391|NCT02658682|"~     Depression (Major Depressive Disorder; MDD) has been dubbed the common cold among the mental~     illnesses and it is also a highly recurrent disorder. Secondary prevention has been~     identified as a key goal in the long-term management of depression. High recurrence rate~     suggests that there are specific vulnerability factors that increase people's risk for~     developing repeated episodes of the disorder. Preventive strategies should identify and~     ameliorate these factors to reduce the individual's risk of subsequent episodes. Biased~     attention for emotional stimuli is central to the cognitive model where increased sensitivity~     to negative cues is believed to fuel the negative thoughts and feelings in depression and~     play a key role in maintaining the illness. Selective biases in attention can be modified by~     a simple computerized technique; The Attention Bias Modification Task (ABM). This project~     aims to investigate whether ABM can reduce surrogate and clinical markers of relapse in a~     large group highly vulnerable to depressive episodes. The effects of ABM, immediately after~     the two weeks intervention, on three key risk factors for depression will be studied:~     Residual symptoms, cortisol awakening response and emotion regulation strategies. The~     participants will be followed up after 1 month, 6 months and 12 months. The hypothesis that~     ABM will reduce subsequent episodes of low mood over the following 12 months in this group in~     a manner predicted by early changes in these risk factors will be investigated. It will also~     be tested if such effects in the lab may be dependent on candidate genes which affect~     serotonin reuptake and which have been implicated in malleability and emotional learning.~     Effects on underlying neural correlates of emotion regulation will be studied in an fMRI~     experiment in a sub-sample and which will also be stratified by serotonin transporter~     genotype (see also NCT02931487). The predictive value of meta cognitions related to~     rumination and the possible mediating effects of automatic thoughts and perceived stress will~     also be investigated in a sub group (see also NCT02648165).~      The characterization of the cognitive, genetic and neural mechanisms underlying the ABM~     effect will have key implications for future treatment development and combination with other~     treatment modalities like pharmacotherapy.~   "
69392|NCT02658669|"~     Many Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn era Veterans have~     suffered a mild traumatic brain injury (mTBI), and now cope with multiple post-injury~     symptoms, including sleep disturbances (especially insomnia). Chronic insomnia in mTBI~     patients has the potential to exacerbate other symptoms, delay recovery, and negatively~     affect many of the cognitive, psychological, and neuromuscular sequelae of mTBI, thereby~     decreasing quality of life. Although Cognitive-Behavioral Therapy for Insomnia (CBT-I) has~     been shown to be an effective evidence-based treatment for insomnia, there are no published~     randomized controlled trials evaluating the potential strengths and/or limitations of CBT-I~     in post-mTBI patients. Therefore, assessing CBT-I in the context of mTBI holds promise to~     provide substantial benefits in terms of improved rehabilitation outcomes in Veterans who~     have suffered mTBI.~   "
69393|NCT02658656|"~     Background Veterans with spinal cord injury (SCI) have many adverse secondary medical and~     quality of life (QOL) changes as a result of immobilization. Veterans with SCI who have~     completed rehabilitation after injury and are unable to ambulate receive a wheelchair as~     standard of care (SOC) for mobility. Powered exoskeletons are a technology that has recently~     become available as an alternate form of mobility by providing an external framework for~     support and computer controlled motorized hip and knee joints to assist with over ground~     ambulation.~   "
69394|NCT02658643|"~     The aim of this prospective randomized controlled study is to determine the benefit-risk~     ratio (success rate, complication rate, tolerance) for patients with biliodigestive~     anastomosis by either continuous or interrupted suture.~   "
69395|NCT02658630|"~     The purpose of this study is to design a predictive model of stroke recovery based on~     baseline measurements of arm movement and brain physiology. The expectation is the~     development of a formula to predict a person's response to an arm rehabilitation program~     provided in the chronic phase (6 months or greater post stroke) of recovery. The study will~     include magnetic resonance imaging (MRI), transcranial magnetic stimulation (TMS), genetic~     testing using saliva, and an arm exercise program consisting of robot-assisted exercise~     combined with functional arm exercise called transition to task training (TTT).~   "
69396|NCT02658617|"~     The findings may guide future investigations on novel therapeutic targets in depressive~     subjects. Based on the depicted link between personality traits and altered brain metabolism~     and function, the latter might be used as supporting objective measures and possible~     biomarkers for increased depression risk.~   "
69397|NCT02658604|"~     RATIONALE:~      Several examples in the literature describe the types of medication management issues~     uncovered during the course of home-based medication reviews. For example, the investigators~     previously reported the outcomes of home medication reviews of 43 homebound community~     pharmacy patients, finding that 58% of patients were keeping medications in the home that~     were expired, duplicates of other current medications, or no longer therapeutically~     appropriate.~      Many of these issues, due to their nature, could be considered to be hidden, i.e. issues~     that are unlikely to be adequately detected or resolved during the course of routine~     interactions between patients and pharmacists in the community pharmacy setting. Currently,~     only homebound patients in Ontario are eligible to receive government-funded home medication~     review services from pharmacists. This limitation in funding eligibility is problematic as it~     reduces the likelihood that non-homebound patients will receive home medication reviews, even~     though this population may also benefit from these services. Indeed, evidence in the~     literature is not limited exclusively to homebound patients, and suggests that non-homebound~     patients are also at risk from home-centered medication management issues and may also~     benefit from home medication reviews.~      PURPOSE:~      Our study aims to characterize the prevalence and nature of hidden in the home medication~     management issues in non-homebound patients. To our knowledge, this study would be the first~     of its kind to focus specifically on this patient population and lend direct evidence in~     support of expanding funding of home medication review services in Ontario to include~     non-homebound patients.~      HYPOTHESIS:~      A subset of ambulatory, non-homebound patients who regularly attend community pharmacies are~     affected by medication management issues that cannot be adequately identified and resolved~     during the course of a typical medication review taking place within the pharmacy. These~     patients would benefit from a full medication review taking place in their own homes, similar~     to what is presently provided under Ontario's MedsCheck at Home program, for which only~     homebound patients in Ontario are eligible.~      RESEARCH QUESTIONS/OBJECTIVES:~        1. What is the frequency of, and what type(s) and severity of, drug-related problems are~          detected during pharmacist visits to patients' homes who would not otherwise qualify for~          a MedsCheck at Home service?~        2. Based on the findings from this study, which criteria would best assist community~          pharmacists in identifying ambulatory patients who may stand to benefit most from a~          home-based medication review?~   "
69399|NCT02658578|"~     Cerebrovascular disease is a major cause of disability worldwide. The catastrophic burden of~     stroke is more dramatic in low- and middle- income countries, and the scarcity of~     evidence-based rehabilitation interventions represents a major challenge to global health~     care. Upper limb weakness is frequent after stroke, but there is no universally accepted~     treatment to effectively improve hand function in patients with moderate and severe motor~     impairment. These are the patients in deepest need of rehabilitative interventions. This~     project addresses this important issue, by testing effects of a novel approach. The~     investigators will non-invasively stimulate peripheral nerves in order to enhance effects of~     motor training aided by an electrical stimulation device in patients with moderate to severe~     hand weakness. Our hypothesis is that peripheral nerve stimulation will enhance effects of~     motor training in patients in the chronic stage after stroke.~   "
69400|NCT02658565|"~     Complete pelvic and para-aortic lymphadenectomy performed at the time of primary surgical~     staging for endometrial cancer increases operative time and surgical morbidity, but appears~     to be necessary in most high grade and deeply invasive cancers. To date, the Mayo Clinic~     approach has not been reproduced, and the investigators propose to validate their algorithm~     at the University of Kentucky utilizing intra-operative consultation (IOC). The preliminary~     data at the University of Kentucky for IOC and endometrial cancer outcomes suggest that the~     investigators are well-suited to perform this investigation. A surgical approach that is~     tailored to the patient's cancer biology is rational, supported by the recent literature, and~     medically compelling since the co-morbidities of many obese, low-risk EC patients put them at~     significantly increased perioperative risk for complete lymphadenectomy.~   "
69401|NCT02658552|"~     To evaluate the short-term efficacy of high intensity focused ultrasound (HIFU) in the~     treatment of benign thyroid nodules~   "
69402|NCT02658539|"~     Research has shown that body composition is a key component of health and future disease~     risk. Being overweight and obese is associated with a higher body fat composition, and a~     greater risk of developing type II diabetes and heart disease. The location where fat is~     stored in the body is becoming increasingly recognised an important predictor of risk, with~     extra fat around the abdomen and waist (referred to as the android pattern of fat~     distribution or 'apple' shape) thought to increase your disease risk than storing fat around~     the thighs and buttocks (gynoid pattern of fat distribution or 'pear' shape). As a result,~     there is significant interest in techniques to accurately monitor and detect changes in body~     composition, and also physiological and lifestyle factors which influence body fat, lean~     tissue mass and bone mineral density. This cross sectional human study will look at how~     physiological, behavioural and genetic factors relate to total body composition in 1,196~     healthy men and women aged between 18 and 70 years. Interested applicants will be invited to~     attend for a single visit at the Hugh Sinclair Unit of Human Nutrition at the University of~     Reading. This visit lasts around two hours and includes noninvasive measures of body~     composition (bio-electrical impedance and dual energy x-ray absorptiometry), arterial~     stiffness and fasting measures of metabolic health. Diet and physical activity will then be~     monitored over a four day period using diet and activity diaries, and an activity monitor.~     The findings from this study will contribute to the evidence base on how subject~     characteristics influence body composition and inform on the design of future human studies~     on body composition methodology.~   "
69403|NCT02658526|"~     The role of surgical stress and anesthesia is unknown in the early childhood. In vitro and~     animal studies showed a risk for treatment with anesthesia in the developmental brain.~     Furthermore, stress is also an important risk factor for cognitive impairment. Therefore, the~     investigators want to investigate in a clinical prospective cohort study the role anesthesia~     and surgery on different cognitive parameters and self-controling mechanisms in children~     under 3 years.~   "
69404|NCT02658513|"~     Recently published European guidance recommends the evaluation of the radiation dose to the~     bone marrow in patients undergoing radioiodine therapy for thyroid cancer. The methods~     described in these guidelines require serial blood samples to be taken from the patient,~     followed by a sophisticated analysis to determine the radiation dose. However, radiation risk~     assessments carried out locally have indicated that a relatively high radiation exposure will~     be received by the operator taking the blood samples, which may prohibit this procedure being~     carried out routinely.~      The radiation dose to the operator will be lowered if the duration of the blood sampling~     procedure were reduced. The investigators hypothesize that the use of a lancet and pipette to~     collect blood from the finger tip will greatly reduce the time spent in proximity to the~     patient, significantly reducing the operator exposure and allowing this procedure to be~     performed routinely. The proposed method is also less invasive for the patient compared to~     the intravenous sampling recommended in the guidelines. A proof-of-principal pilot project~     using radioiodine diluted to the expected concentration in blood has indicated that using~     very small volumes of blood (such as from a lancet) does not compromise the accuracy of the~     dosimetry measurement when compared to large-volume standard blood samples.~      The primary aim of this study is to investigate whether sampling a small volume of blood~     using a lancet and pipette can replace standard intravenous blood samples for bone marrow~     dosimetry in patients undergoing radioiodine treatment for thyroid cancer. Statistical tests~     will determine whether there is a significant difference between the doses calculated using~     each blood sampling method. In addition, the investigators will measure the radiation~     exposure received by the operator during each procedure using Electronic Portable Dosimeters.~     The results of these measurements will be used to quantify the reduction in operator~     radiation exposure afforded by the new technique.~   "
69405|NCT02658500|"~     This study evaluates the early infant feeding in the infant intestinal microecology and the~     long term health. 300 healthy term newborns were involved into the study on its first stage.~     Depending on the type of feeding the infants were divided into 3 groups with random~     allocation to one of the formula feeding groups: the group A included 100 infants consuming~     the formula supplement with superior quality whey protein, the group B -100 infants fed with~     a standard formula, and the group C -100 infants who were breastfed.~   "
69406|NCT02658487|"~     This phase II trial studies how well vosaroxin and cytarabine work in treating patients with~     untreated acute myeloid leukemia. Drugs used in chemotherapy, such as vosaroxin and~     cytarabine, work in different ways to stop the growth of cancer cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading.~   "
69407|NCT02658474|"~     The purpose of this study is to determine whether group based Acceptance and Commitment~     Therapy (ACT) at a university hospital clinic is superior to treatment in a primary care~     setting among patients with chronic pain.~      Hypothesis:~      i) A group based ACT treatment leads to less pain and greater Health Related Quality of Life~     (HRQOL) in patients with chronic pain than treatment in a primary care setting.~      ii) The improvement in pain and HRQOL is mediated through an increased degree of pain~     willingness and involvement in activities.~      iii) Improvement of pain and HRQOL after the two treatments is associated with demographic,~     psychosocial and somatic characteristics.~   "
69410|NCT02658435|"~     The study aims to provide evidence of retinal safety to support the use of tafenoquine as a~     potential single dose radical cure treatment for patients with Plasmodium vivax (P. vivax)~     malaria (i.e., co-administration of a schizonticidal drug with TQ). The study will be~     conducted as a single masked, randomized, placebo-controlled, parallel group design. It will~     assess retinal changes from baseline using spectral domain optical coherence tomography (OCT)~     and fundus auto fluorescence (FAF) at Month 3 (90 days) post-dose in adult healthy volunteers~     (participants). A placebo control group will be used to compare the results in the TQ group.~     Interim analysis will be conducted after completing 100 out of 300 participants in TQ group~     and 50 out of 150 participants in matched placebo.~   "
69411|NCT02658422|"~     This study is conducted to determine whether the test product (GW483100 10 mg containing~     montelukast sodium equivalent to 10 mg of montelukast) is bioequivalent to the reference~     montelukast sodium 10 mg tablets (innovator product) in healthy adult volunteers under~     fasting conditions. This is an open-label, balanced, randomized, single dose, two-way~     crossover study, enrolling 32 healthy human subjects to ensure at least 28 subjects complete~     the study. Each subject enrolled will participate in two treatment periods separated by a~     washout period of at least 7 days and no more than 14 days between dosing occasions. Total~     duration in the study for each subject will be approximately 7 weeks from screening to the~     subject's last visit.~   "
69412|NCT02658409|"~     A Multicenter, Randomized, Double-blind, Active-controlled, Parallel, Non-inferiority, Phase~     III Study.~   "
69413|NCT02658396|"~     This research study is studying a combination of targeted therapies known as GO-203-2C and~     bortezomib as a possible treatment for multiple myeloma that has either progressed or not~     responded to treatment.~   "
69414|NCT02658383|"~     Nearly 3 billion people rely on biomass combustion to meet basic domestic energy needs. Many~     households use traditional cookstoves to meet these energy needs, which can result in~     extremely high indoor air pollution concentrations. Indoor air pollution from biomass~     combustion accounts for an estimated 3.9 million premature deaths per year, representing~     about 4.8% of the global disease burden. Improved stove designs have the potential to~     substantially reduce indoor air pollution exposures. However, there are few randomized~     intervention trials, and previous stove intervention studies have been plagued by low~     improved stove adoption and sustained use, severely limiting interpretations of these~     studies. This research proposes to conduct community surveys and in-depth interviews among~     Honduran cookstove users to gain insight into the complex pathways surrounding barriers to~     and predictors of sustained improved cookstove adoption (among the target population for the~     proposed intervention). This information will be used to conduct and enhance a randomized~     improved cookstove intervention among 300 Honduran families, incorporating qualitative and~     quantitative measures of cookstove use and measuring pre- to post-intervention changes in~     pollutant exposures and subclinical indicators of cardiovascular health.~      The primary goals are twofold:~        -  To incorporate community-engaged approaches throughout all aspects of the research~        -  To maximize sustained stove use (thereby maximizing the health impact of the~          intervention) to achieve valid exposure-response estimates.~      Both objectives utilize innovative strategies to fill knowledge gaps. The research team will~     build upon previous studies in Latin America that have focused on identifying and validating~     appropriate field techniques for exposure and health assessments in rural areas of developing~     countries.~      In summary, the proposed project will provide insight regarding barriers/predictors of~     sustained cookstove adoption, an issue impeding research in this field; assess the~     relationship between stove use and indicators of cardiovascular health, a substantial and~     quickly growing disease burden in developing countries; and result in a more comprehensive~     and valid assessment of the impact of a cookstove intervention.~   "
69415|NCT02658370|"~     The purpose of this pilot study is to investigate feasibility and patients´ assessment using~     an animated home-based exercise program (Software Wii-fit of the Nintendo Wii game console)~     for patients with rheumatoid arthritis.~   "
69416|NCT02658357|"~     The study will be a 6-month, open-label, multiple center study in approximately 50 stable~     subjects diagnosed with schizophrenia or schizoaffective disorder to evaluate the safety,~     tolerability, and pharmacokinetics of Risperidone and 9-OH-Risperidone following implantation~     of two or three, 300 mg Risperidone Implants.~   "
69417|NCT02658344|"~     The purpose of this study is to investigate the efficacy and safety of autologous~     transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with Knee~     Osteoarthritis.~   "
69418|NCT02658331|"~     The aim of our study is to assess the analytical and clinical performance of the FilmArray~     (FA) BioThreat-E test (BioFire®) for the diagnosis of Ebola virus disease in the field in~     Guinea versus conventional molecular techniques.~   "
69419|NCT02658318|"~     In cleft surgery there is no current general agreement on the treatment strategy of patients~     with the Pierre Robin Sequence. The timing of surgery and the surgical approach depends on~     the treating physician or the hospital facility. Literature regarding peri- and postoperative~     complications in the target population are lacking.~      The investigators aim to retrospectively review the charts of all cleft patients, both PRS~     and non-PRS, treated with an adapted Furlow palatoplasty between 01/01/2011 and 31/08/2015.~     The incidence of peri- and postoperative complications, with a specific focus on respiratory~     complications, will be examined. The value of demographic, surgical and postoperative~     parameters will be examined as potential risk factors for the development of complications.~   "
69420|NCT02658305|"~     Bicortical screws have been widely used for mandibular osteosynthesis during orthognathic~     surgery.Transoral placement of bicortical screws is a rigid fixation method in orthognathic~     surgery, which is less often used.~      The aim of this study was to compare postoperative outcome of transoral versus transbuccal~     bicortical screw placement during orthognathic surgery.~      This study comprises an academic, retrospective, monocentric study in which the charts of~     orthognathic patients operated between January 2010 and December 2012 were retrospectively~     reviewed. Postoperative complications were registered. Demographic, dental and surgical~     parameters are examined as potential risk factors for the occurence of postoperative~     complications.~   "
69421|NCT02658292|"~     A Double-Blind, Randomized, Vehicle-Controlled, Multicenter Study to Evaluate the Efficacy~     and Safety of NAFT-900 in Children Aged 6 to < 13 Years with Tinea Capitis~   "
69422|NCT02658279|"~     The purpose of this study is to test if the study drug called pembrolizumab could control the~     growth or shrink the cancer but it could also cause side effects. Researchers hope to learn~     if the study drug will shrink the cancer by half, or prevent it from growing for at least 6~     months. Pembrolizumab is an antibody that targets the immune system and activates it to stop~     cancer growth and/or kill cancer cells.~   "
69423|NCT02658266|"~     Adults with complex congenital heart disease have impaired muscle function compared both to~     health controls and patients with lesions classified as simple. There is only one study~     assessing the effects of resistance training in patients palliated with Fontan procedure. The~     hypotheses of the present study is that home based resistance training will improve muscle~     function in adults with different complex congenital hear diseases.~   "
69424|NCT02658253|"~     The primary objective of the study is to evaluate the safety of 3 different dosages (20µg -~     50µg and 100µg) of a placental malaria vaccine candidate (PRIMVAC vaccine) adjuvanted either~     with Alhydrogel® or GLA-SE, and administered at D0, D28 and D56 in healthy European and~     Burkinabe adults.~      The safety and the tolerability of the vaccine will be assessed on the rate of solicited and~     unsolicited events/reactions The safety profile will included local and systemic~     reactions/events as well as the biological safety, based on a clinically significant change~     of the baseline value of the main biological criteria~   "
69425|NCT02658240|"~     This randomized, controlled, observer-blinded study clinical trial was designed to evaluate~     ultrasound-guided fascia iliaca compartment block with ropivacaine and periarticular~     infiltration with ropivacaine for postoperative pain management after total hip arthroplasty.~   "
69426|NCT02658214|"~     Durvalumab and Tremelimumab in combination with first-line chemotherapy in the following~     indications: Ovarian/peritoneal/fallopian tube cancer, SCCHN, TNBC, SCLC and gastric/GEJ~     cancer, PDAC, ESCC.~   "
69427|NCT02658201|"~     In haematological malignancy and in immunocompromised patients, constipation is a common~     symptom caused by a number of factors during treatment. In current clinical practice, an~     abdominal radiograph is the first imaging investigation for constipation and non specific~     abdominal pain to support or exclude the clinical suspicion. Children are more sensitive to~     radiation induced adverse effects especially in the thyroid gland and bone marrow.~     Immunocompromised patients are at risk of developing a second malignant neoplasm. MRI is an~     alternative imaging modality without ionizing radiation. Imaging the peritoneal cavity on~     abdominal MRI has always been challenging primarily because of bowel motion and a long~     acquisition time for standard T1 and T2 weighted sequences. Recent development of an~     ultrafast 2 dimensional FIESTA sequence developed by GE (General Electric) Healthcare based~     on the balanced steady state free precession (b-SSFP) pulse sequence has several advantages:~     motion insensitivity ( does not interfere with peristalsis), sharp edge definition and higher~     contrast when compared with the standard SSFSE pulse sequence. FIESTA is well suited for~     abdominal imaging as it produces motion- free images, allowing clear delineation of~     intra-peritoneal and retroperitoneal anatomy and is capable of depicting the vascular anatomy~     and lymph-adenopathy.There is a wide spectrum of diseases which could cause abdominal pain in~     our study group with constipation being the most common cause but MRI could potentially~     detect more serious bowel-related chemotherapy induced complications such as typhlitis,~     pneumatosis coli, veno-occlusive disease, pancreatitis and intra abdominal abscess, which~     would not be apparent on abdominal radiograph.~   "
69428|NCT02658188|"~     The objective of this study is to evaluate the efficacy and safety of ASP8825 (gabapentin~     enacarbil) for long-term treatment of restless legs syndrome patients.~   "
69429|NCT02658175|"~     An Open-Label Study of Volanesorsen (IONIS 304801) Administered Subcutaneously to Patients~     with Familial Chylomicronemia Syndrome (FCS)~   "
69430|NCT02658162|"~     Safety and efficacy study of SANGUINATE on reduction of delayed graft function (DGF) in~     patients who will be recipients of a donation after brain death (DBD) donor kidney.~   "
69431|NCT02658149|"~     The primary objective of this study is to examine whether there is a difference in the level~     of resting pain following total hip arthroplasty with an anterior approach with use of a~     psoas compartment block versus a local periarticular anesthetic infiltration~   "
69432|NCT02658136|"~     Exercise capacity in continous-flow left ventricular assist device (CF-LVAD) patients remains~     severely reduced post-implant. While the effect of right ventricular (RV) failure early after~     pump implantation, and its effect on outcome has been extensively studied, the effects of~     late RV failure on exercise capacity and quality of life (QOL) has been sparsely described.~     Thus the purpose of this study is to examine RV function and the association to exercise~     capacity in CF-LVAD patients.~   "
69433|NCT02658123|"~     Preventing complications and readmission after ostomy surgery will decrease the cost of~     healthcare, improve patient safety, reduce the cost of durable medical equipment required by~     ostomates, ensure continued specialized care is available, and potentially improve both short~     and long-term quality of life (QOL) for patients by reducing morbidity and mortality~     associated with ostomy surgery. The purpose of this study is to measure the effectiveness of~     patient centered interventions/care pathways and to determine the impact on healthcare~     utilization, 30-day hospital readmissions, and QOL.~   "
69434|NCT02658110|"~     The proposed study aims to determine the metabolic and appetite responses to standard~     breakfast and lunch meals whilst altering the timing of whey protein supplementation.~     Currently, the designs implemented in many studies mean that it is unclear whether an optimum~     time for whey protein consumption exists in order to promote the greatest acute health~     benefits. A number of studies have investigated the effects of whey protein when consumed as~     a preload to a subsequent meal, whilst benefits have also been shown when whey protein is~     ingested with a meal. The proposed study will therefore investigate strategies of whey~     protein supplementation that vary in their practical applicability, using meals that reflect~     regular eating behaviours throughout the population in a sample of overweight/obese~     individuals.~      Findings from this study may provide important information regarding the efficacy of whey~     protein supplementation before, during and after a composite meal, and its effect on the~     handling of a subsequent mixed-macronutrient meal.~   "
69435|NCT02658097|"~     This study looks at patients with advanced lung cancer. Participants in this study will be~     randomized into two groups. The first group will have radiation plus a drug (pembrolizumab).~     The second group will have only the drug (pembrolizumab). Tumors of participants will be~     measured to see if the addition of radiation changes the growth of the tumor compared to the~     drug alone.~   "
69436|NCT02658084|"~     The study proposes to evaluate the safety and efficacy of the combination of trastuzumab~     emtansine (T-DM1) and vinorelbine in HER2+ metastatic breast cancer patients.~   "
69456|NCT02657824|"~     Left ventricular ejection fraction (LVEF) is a parameter that should be evaluated rapidly to~     the patients, admitted to the emergency department with shortness of breath. The~     investigators aimed to investigate correlation between LVEF and 4 different mitral valve~     movements which alternate to the classical LVEF assessing methods and evaluate these methods~     can be used or not in the emergency department.~   "
69437|NCT02658071|"~     Glaucoma is a very frequent disease in Brittany. In glaucoma the retinal ganglion cells and~     their axons slowly die with visible changes at the optic nerve head (cupping). Without early~     diagnosis and effective treatment or with delayed treatment decrease of visual acuity or~     blindness become.~      In secondary pseudoexfoliation glaucoma grayish-white deposits of abnormal proteins are found~     on all surfaces of eye irrigated by the aqueous humor. The deposits of PEX material inside~     the trabecular meshwork decrease aqueous humour outflow and the intraocular pression raise.~     The exfoliation material is found on the surface of the lens capsule with frequent~     developement of nuclear cataract . After cataract surgery the intra ocular pressure (IOP)~     decrease.~      Some recent study have found decreasing ocular volume variation associated to IOP fluctuation~     in night after cataract surgery in normal pressure glaucoma patients. In our study we want~     see if it's the same thing in pseudoexfoliation glaucoma patients.~   "
69438|NCT02658058|"~     Traditionally, spinal anesthesia is performed using the palpation of bony landmark to~     identify the level and point of entry of the spinal needle. Recently, ultrasound imaging has~     become an increasingly popular procedure among anesthesiologists to guide neuraxial blockade.~     Most of the studies on pre-procedural ultrasound-guided neuraxial techniques are limited to a~     midline approach using a transverse median views. The parasagittal oblique view consistently~     offers better ultrasound view of the neuraxis compared to the transverse median view.~     However, it is still not evident whether these superior parasagittal oblique views will lead~     to an easier paramedian needle insertion. In the literature, there are no studies directly~     comparing the US-guided paramedian approach using the parasagittal oblique (PSO) view, the~     US-guided midline approach using the transverse median view, and the conventional landmark~     midline approach to perform spinal anesthesia in the elderly patients, in particular for the~     teaching of novice anesthesia residents.~   "
69439|NCT02658045|"~     The trial shall assess the accuracy of the Oxitone® 1000 in measuring oxygen saturation, by~     comparing its measurement to reference devices: non-invasive SpO2 and pulse-rate values~     determined by a pulse oximeter. A total of approximately 40 subjects: 20 healthy and 20 COPD~     (chronic obstructive pulmonary disease ) patients will be enrolled. These subjects will be~     enrolled at the medical center pulmonary department and will be recruited from the clinic~     patient base. The subjects will be represented by male and female adults who optimally cover~     a range of ethnic backgrounds (skin pigmentation). All testing will be performed in singleton~     and in a blinded fashion. This study will be conducted with the approval of the medical~     center ethics committee.~      This is a comparison open study with no subject follow-up.~   "
69440|NCT02658032|"~     The purpose of this study is to test the efficacy of two separate, sequential interventions~     to promote tobacco cessation/reduction in patients who are screened for lung cancer or are~     eligible for lung cancer screening. Each intervention will be compared to standard of care.~     The first intervention will be a personalized message intervention, the second intervention~     will consist of a biofeedback-based intervention.~   "
69441|NCT02658019|"~     This is a single-arm phase II trial of Pembrolizumab (Keytruda) in patients with advanced,~     unresectable hepatocellular carcinoma. The primary objective is to assess its therapeutic~     efficacy in patients with unresectable hepatocellular carcinoma (HCC). The primary endpoint~     is disease-control rate (DCR) defined as the proportion of patients achieving a best overall~     response of either a complete response (CR), partial response (PR) or stable disease (SD)~     (that is maintained for at least 8 weeks).~      Secondary endpoints include progression-free survival (PFS), overall survival (OS), objective~     response rate (ORR), duration of response (DOR), and toxicity profile of Pembrolizumab. The~     investigators will also evaluate the expression levels of Programmed death-ligand 1 (PD-L-1)~     in tumor tissue, as well as serum titers of hepatitis B or C in patients with hepatitis B or~     C, respectively, for whom specimens are available.~   "
69442|NCT02658006|"~     The purpose of this prospective observational cohort study is to evaluate multimodal~     monitoring technologies in the perioperative care of cardiac surgical patients. Right~     ventricular pressure tracings, near infrared spectroscopy (NIRS) and transthoracic~     ultrasonography will be studied for their ability to detect and predict complications such as~     right ventricular failure, renal failure and respiratory failure.~   "
69443|NCT02657993|"~     The purpose of this study is to determine whether hypnosis is efficacious in reducing~     musculoskeletal pain in breast cancer survivors taking aromatase inhibitors, and by doing so,~     whether hypnosis can help survivors to be more adherent to their medication regimen.~   "
69444|NCT02657980|"~     Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification:~     Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject,~     Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment~   "
69445|NCT02657967|"~     This study is an observational study to determine predictors of sudden cardiac death or~     appropriate ICD therapy in patients with non-ischemic cardiomyopathy. Patients will be~     followed for 36 months for the occurrence of sudden cardiac death~   "
69446|NCT02657954|"~     Cognitive impairments are present in up to 80% of homeless individuals, and may contribute to~     homelessness in Operation Enduring Freedom / Operation Iraqi Freedom / Operation New Dawn~     (OEF/OIF/OND) Veterans. The investigators propose to investigate these issues in homeless,~     treatment-seeking returning Veterans, who arguably face multiple potential barriers to~     recovery and reintegration, and with whom there is the greatest opportunity to prevent~     long-term homelessness. The investigators plan to conduct a 15-week randomized controlled~     trial of an evidence-based, 10-week Compensatory Cognitive Training (CCT) intervention vs. an~     education control condition to examine the effects of cognitive rehabilitation in this~     Veteran population. The investigators expect CCT-associated improvements in cognition and~     functional skills and generalization to reduced levels of disability, along with improved~     community reintegration outcomes. By attending to and treating cognitive impairments, the~     investigators can potentially prevent future homelessness and its negative health~     consequences, resulting in both healthcare cost savings and improved quality of life for~     Veterans.~   "
69497|NCT02657291|"~     Patients for upper limb surgeries who are candidates for infraclavicular block will be~     screened. Two techniques of infraclavicular block will be compared. Measured outcomes are~     performance times, block onset times, patient satisfaction, quality of block, and requirement~     for supplementary analgesia.~   "
69447|NCT02657941|"~     People with severe mental illness have an increased risk of somatic comorbidities such as~     metabolic syndrome, obesity, hypertension, dyslipidemia and diabetes mellitus, which induce~     an increased risk of early mortality, mainly because of cardiovascular diseases.~      These high cardio-metabolic risks result of several factors such as lack of access to medical~     care, a poor and unbalanced nutrition, physical inactivity and smoking but they are also~     exacerbated by antipsychotic medications and anti-epileptic mood stabilizers prescribed to~     treat their psychiatric disorder.~      These prevention and awareness interventions in lifestyle are most often implemented in~     ambulatory stabilized patients. Also weight gain occurs in the early months of treatment. The~     therapeutic education program evaluated in this study seeks to potentiate the effectiveness~     of these preventive measures through early awareness in hospitalized patients.~      Finally, this study aims to compare the efficacy of two early and short programs on health~     behavior: first a program inspired by motivational interviewing and behavioral psychotherapy~     and secondly an exclusively educational program (information, formative assessment).~   "
69448|NCT02657928|"~     This phase II trial studies how well ribociclib and letrozole work in treating patients with~     estrogen receptor (ER) positive ovarian, fallopian tube, primary peritoneal, or endometrial~     cancer that has returned (come back) after a period of improvement. Ribociclib may stop the~     growth of tumor cells by blocking some enzymes needed for cell growth. Cancer cells that are~     estrogen receptor positive may need estrogen to grow. Letrozole lowers the amount of estrogen~     made by the body and this may stop the growth of tumor cells that need estrogen to grow.~     Giving ribociclib together with letrozole may be an effective treatment in patients with~     ovarian, fallopian tube, primary peritoneal, or endometrial cancer.~   "
69449|NCT02657915|"~     The primary objective of the study is to assess full-field visual evoked potential (FF-VEP)~     latency in subjects who were enrolled in Study 215ON201 (NCT01721161) 2 years (+ 4 months)~     after the last study visit. The secondary objective is to assess clinical progression and~     severity of central nervous system (CNS) demyelinating disease in subjects who were enrolled~     in Study 215ON201 2 years (+ 4 months) after the last study visit. No study drug dosing is~     planned for this study.~   "
69450|NCT02657902|"~     The purpose was to evaluate whether the additional use of the Gamma3 ® RC Lag Screw is~     associated with a reduced cutout rate in patients with OTA/AO 31A1-3 inter-trochanteric~     fractures.~   "
69451|NCT02657889|"~     This Phase 1/2 study will evaluate the safety and efficacy of combination treatment with~     niraparib and pembrolizumab (MK-3475) in patients with advanced or metastatic triple-negative~     breast cancer or recurrent ovarian cancer. (KEYNOTE-162)~   "
69452|NCT02657876|"~     This study is designed as a prospective, open-label trial focused on assessing the safety and~     tolerability of ExpressGraft-C9T1 skin tissue in the treatment of diabetic foot ulcers (DFU).~     Because the focus is on safety rather than efficacy, a standard of care comparator is not~     included in this first-in-human study. Targeted enrollment for this study is up to 6 subjects~     with a confirmed diagnosis of diabetes and who have foot ulcers. Subjects will each receive a~     single application of ExpressGraft-C9T1 skin tissue on a single identified study DFU~     following a 10-14 day run-in period. Any subjects requiring additional treatment will receive~     protocol-defined dressings through Study Treatment Week 12 as necessary. Enrollment will~     occur with a minimum of one week between each subject.~   "
69453|NCT02657863|"~     This study is being conducted to collect and analyze biospecimens (blood and urine) and~     clinical data from patients with prostate cancer as well as healthy volunteers to better~     understand the differences between cancer cells and normal tissues with the goal of~     developing a better way to detect and track the treatment of prostate cancer.~        -  These samples are being collected to conduct research to accomplish the goal of~          improving cancer therapies, biomarkers, and hopefully lead to more effective treatment~          of prostate cancer.~        -  The samples that you are providing as a patient with prostate cancer will be used in~          future research.~        -  Your biospecimens will be compared to the cancer and normal volunteer specimens from~          other participants to understand genetic differences between normal and cancer cells.~          Genetic material, including DNA and RNA, will be obtained from samples, stored, and used~          for evaluation.~        -  Clinical information and samples will be collected and stored for ongoing research. This~          is a necessity because improved diagnosis, prognosis and treatment of cancer in the~          future depend upon the ongoing analysis of basic research findings and clinical~          outcomes. This type of research may improve the lives of future patients with cancer.~      Men between the ages of 18 and 100 with a diagnosis of cancer undergoing standard therapy~     with radiation may join.~   "
69454|NCT02657850|"~     Cancers located in the upper aerodigestive tract of the head and neck region present unique~     management challenges due to the crucial functions in this anatomic region along with its~     anatomic density. As such, cancers themselves and the actual treatment can affect these~     functions. Of these, the ability to effectively and safely transport a swallow bolus from the~     oral cavity to the esophagus is particularly important. This consideration has in fact been a~     major source of debate regarding the optimal management for head and neck cancers as both~     oncologic-effective and function-preserving therapies are desired. Accomplishing this~     therapeutic goal has been elusive and can be attributed to a lack of tools that effectively~     and longitudinally evaluate swallow function over the course of a treatment and in follow-up.~     As such, investigators surprisingly lack a clear understanding of the natural history of~     treatment -related swallow dysfunction (dysphagia) regardless of the treatment modality. As~     such, understanding the prevalence of this significant complication is in fact not well~     established. Understanding the true prevalence of treatment-related dysphagia is in fact~     critical to establish as it will help guide decisions as to whether or not treatment~     strategies require modification including de-intensification of treatment that is receiving~     considerable attention for favourable prognosis patients associated with the human~     papillomavirus (HPV).~      To address this problem, winvestigators hypothesize that the quantitative and validated~     patient-reported outcome (PRO) instrument, the Sydney Swallow Questionnaire (SSQ), can be an~     effective tool to longitudinally measure swallow function to determine the natural history of~     head and neck cancer treatment-related swallow dysphagia. The SSQ is particularly well suited~     for longitudinal evaluation of swallow function as it quantifies various aspect of~     patient-perceived swallow function in contrast to other swallow PROs that measure the impact~     of swallow function on quality of life domains. To determine the two-year prevalence of~     dysphagia, investigators will employ a multi-institution prospective study design using our~     Oncospace® web-portal to facilitate secure prospective data curation and analysis that will~     include evaluations before, during and following standard of care definitive cancer treatment~     for a total of 36 months in the follow-up period.~   "
69455|NCT02657837|"~     The Lung Clearance Index, measured by multiple breath washout, is a measure of lung function~     that is considered a research tool in Canada as the device used to measure it is not approved~     by Health Canada. The study will assess lung function in patients undergoing routine lung~     function testing for clinical indications (Cystic Fibrosis and Other Respiratory Diseases).~     In addition, healthy controls of different ages will be asked to perform this lung function~     test to gain reference data that can be used to interpret LCI in patients with lung disease.~   "
69457|NCT02657811|"~     Embryo culture and selection has been a continuous challenge in evolution since the birth of~     In Vitro Fertilization (IVF). Traditionally, embryo quality and its presumed suitability for~     transfer were assessed based on morphologic features. However, the consensus as to the~     optimal time points for embryo assessment and as to 'preferable' characteristics have been~     challenging. Alongside this has been the challenge of achieving balance between multiple~     points of assessment, yet stabilizing the embryo environment for growth. In standard~     incubation, each new morphological assessment of embryos in culture theoretically creates an~     additional disruption to culture.~      Most recently, time-lapse incubators (TLI) have been introduced as a novel embryo culture~     system attempting to limit culture disturbances. These incubators have been integrated with~     digital imaging, allowing for a substantial limitation in embryo handling and environmental~     disturbances. They have also introduced new morphokinetic parameters to embryo assessment and~     to optimizing selection of embryos. Thus far, a limited number of studies have examined the~     clinical outcomes and value of time lapse monitoring systems versus the more ubiquitous~     incubators (e.g. multichamber) for reproductive outcomes. In particular, the isolated value~     of morphokinetics in embryo assessment and of this new stable culture environment in TLI are~     still in question.~      The objectives of this study are to prospectively assess and compare fertility outcomes when~     embryos are cultured in the TLI system versus more traditional bench incubators (BI). We will~     specifically assess the added value of the closed and isolated TLI compared to BI on~     reproductive outcomes, as well as the value of morphokinetic grading in IVF.~   "
69458|NCT02657798|"~     This study will investigate the biological pathways involved in anti-depressant resistance~     that increase risk of cardiovascular disease in people with depression.~   "
69459|NCT02657785|"~     This study suggests that R-IDARAM combined with intrathecal immunochemotherapy may be high~     effective in primary central nervous system lymphoma (PCNSL) patients.~   "
69460|NCT02657772|"~     The purpose of this study is to assess the safety and efficacy rates of the treatment of~     small intracranial aneurysms with Stryker Neurovascular's Target® 360 Ultra coils which are a~     type of platinum coils used to occlude aneurysms.~   "
69461|NCT02657759|"~     This research aims to evaluate the effect of CARDICHOL chronic consumption (12 weeks) on~     lipid metabolism and especially on blood LDL cholesterol in volunteers with moderate~     hypercholesterolemia.~   "
69462|NCT02657746|"~     Background: High blood pressure (BP) is the leading attributable risk for cardiovascular~     disease (CVD). In rural South Asia, hypertension remains to be a significant public health~     issue with sub-optimal rates of case finding and management. The goal of the full-scale study~     is to evaluate the effectiveness and cost-effectiveness of multicomponent primary care~     strategies on lowering blood pressure among adults with hypertension in rural communities in~     Bangladesh, Pakistan, and Sri Lanka.~      Methods/Design: The mixed-methods, stratified cluster randomized controlled trial~      Intervention: The multi-component interventions (MCI) is comprised of all the following five~     components: 1) home health education (HHE) by government community health workers (CHWs),~     plus 2) blood pressure (BP) monitoring and stepped-up referral to a trained general~     practitioner (GP) using a checklist, plus 3) training public and private providers in~     management of hypertension and using a checklist, plus 4) designating hypertension triage~     counter and hypertension care coordinators in government clinics, plus 5) a financing model~     to compensate for additional health services and provide subsides to low income individuals~     with poorly controlled hypertension.~      Usual care: Will comprise existing services in the community without any additional training.~      Participants: The trial will be conducted on 2550 individuals aged 40 years or older with~     hypertension (systolic BP ≥ 140 mm Hg or diastolic BP≥ 90 mm Hg, or on antihypertensive~     therapy) in 30 rural communities of Bangladesh, Pakistan and Sri Lanka. Out of the 2550~     individuals, 420 with poorly controlled BP (Systolic BP≥160 mmHg or Diastolic BP≥100 mmHg)~     will be selected, 14 from each community, to investigate the effect of MCI on results from~     ambulatory BP monitoring.~      Qualitative component: Stakeholders including policymakers, district managers, and community~     health workers, GPs, hypertensive individuals and family members in the identified clusters~     will be surveyed.~      Outcome: The primary outcome will be change in systolic BP from baseline to follow-up at 24~     months post randomization. The cost effectiveness outcome is the incremental cost of MCI per~     unit reduction in BP over the two year time period and in terms of incremental cost per CVD~     DALYs averted.~   "
69463|NCT02657733|"~     Respiration rate is a critical vital sign that provides early detection of respiratory~     compromise and patient distress. Continuous monitoring of respiration rate is performed in~     patients under different clinical conditions, including post-surgery or different respiratory~     diseases. Clinician observation, pulse oximetry, and capnography are used individually or in~     combination to monitor ventilation during sedation and on post-surgical patients. The~     American Society of Anesthesiologists mandates the monitoring of respiration by measuring end~     tidal carbon dioxide (RRetco2) during procedural sedation and anesthesia. Other techniques~     for respiration rate measurement include different technologies such as acoustic respiratory~     rate (RRa). The aim of this study is to compare the accuracy of RRetco2 and RRa under certain~     respiratory conditions.~   "
69464|NCT02657720|"~     Respiration rate is a critical vital sign that provides early detection of respiratory~     compromise and patient distress. Continuous monitoring of respiration rate is performed in~     patients under different clinical conditions, including post-surgery or different respiratory~     diseases. Clinician observation, pulse oximetry, and capnography are used individually or in~     combination to monitor ventilation during sedation and on post-surgical patients. The~     American Society of Anesthesiologists mandates the monitoring of respiration by measuring end~     tidal carbon dioxide (RRetco2) during procedural sedation and anesthesia. Other techniques~     for respiration rate measurement include different technologies such as acoustic respiratory~     rate (RRa). The aim of this study is to compare the accuracy of RRetco2 and RRa under certain~     respiratory conditions.~   "
69465|NCT02657707|"~     A prospective, multicenter, single-arm, open label clinical study to evaluate the safety and~     effectiveness of MicroVention, Inc. Roadsaver™ Carotid Stent System used in conjunction with~     the Nanoparasol® embolic protection system for the treatment of carotid artery stenosis in~     patients with elevated risk for adverse events following carotid endarterectomy.~   "
69466|NCT02657694|"~     REDEMPTION (Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods) is~     observing and collating the treatment course, safety profile, and outcomes of patients around~     the world who are choosing to self import generic versions of the Direct Acting Antivirals~     Sofosbuvir, Ledipasvir and Daclatasvir from countries like China, India and Bangladesh.~   "
69467|NCT02657681|"~     This is a randomized sham-controlled double-blind study to test the hypothesis that~     transcranial static magnetic field stimulation (tSMS) of the motor cortex improves~     levodopa-induced dyskinesias in patients with Parkinson's disease. Half of the patients will~     receive real tSMS treatment, the other half will receive sham treatment (placebo).~   "
72101|NCT02623192|"~     This registry was proposed to investigate the epidemiology of respiratory mechanics in~     patients with ARDS through collecting data from a QI project which was constituted with~     systematic assessments of respiratory mechanics and gas exchange.~   "
69468|NCT02657668|"~     The study was quasi-experimental including patients in two intervention and control groups.~     Three measurements were done: pretest, post-test, and a two-months follow-up. The study~     population included patients with irritable bowel syndrome(diagnosed by specialists and based~     on the criteria of Rome III), who referred to a general Hospital. Fifty two irritable bowel~     syndrome patients were selected and assigned to two experiment (26 cases) and control (26~     cases) groups. The criteria below were considered in selection of patients.~      Inclusion criteria: 1) Patients should not have participated in other psychological~     interventions concurrently; 2) Participants had not reported diagnosis of non-functional~     gastrointestinal illnesses. 3) Women patients had not been in pregnancy; 4) Participants had~     not met diagnosis of schizophrenia and bipolar disorders.~      Exclusion criteria: Three or more absences in the group sessions Co-variate variables: 1)~     demo-graphical variables (age, birth order, and education); 2) clinical variables (global~     psychological status, mind-body attribution, and duration of disease).~   "
69469|NCT02657655|"~     Kinesia 360 is an ambulatory symptom monitoring device for Parkinson's Disease (PD). The aim~     of this study is to investigate the impact, validation, and usability of the Kinesia 360~     system.~   "
69470|NCT02657642|"~     Background : The transitional care OMAGE-P combines three best practices recommendations from~     the French National Authority for Health (HAS) (i) a comprehensive review of diagnosis and~     treatments (ii) a standardized medical report and (iii)a patient education program~     specifically designed for older people with multiple chronic conditions and polypharmacy.~     This transitional care is implemented in a pilot general hospital with the support of French~     ministry of Health and Regional Agency for Health of Ile de France . The aim of the study is~     to assess the impact of the OMAGE P transitional care on the readmissions of non demented~     older people aged 75 years and over within the 3 months following their discharge to home and~     its cost-effectiveness .~      Study Population: non demented people aged 75 years and over admitted in emergency (ie via an~     emergency department ) in the participating units~      Study design:~      Observational prospective monocentric non randomized comparative study Exposed patients:~     eligible patients admitted in participating units and who does not oppose to the collection~     of his personal data. The hospital physician in charge will conduct the comprehensive review~     of diagnosis and treatments and will do the standardized medical report. Patient education~     program will be conduct by the hospital physician and the OMAGE nurse during the~     hospitalization (two sequences) and during 2 to 4 home visits in the month following patient~     's discharge from hospital.~      Non exposed patients: eligible patients from the usual care arm of the RCT OMAGE. To ensure~     that risk for emergency readmissions is not different between exposed and non exposed , the~     rate of emergency readmissions of non exposed group will be compared with the one of eligible~     patient admitted in the participating units in 2013 and 2014.~      Setting: General hospital of Eaubonne : geriatric department (acute geriatric unit,~     rehabilitation unit , geriatric mobile unit ) and internal medicine department Number of~     subjects to be included: 484 (242 in each arm). The data for the 242 non exposed patients are~     still available, 242 patients has to be included in the exposed group~   "
69471|NCT02657629|"~     The purpose of the study is to determine if a continuous feeding regimen as compared to an~     intermittent bolus feeding regimen leads to improved weight gain in infants with hypoplastic~     left heart syndrome (HLHS) after stage 1 procedures.~   "
69472|NCT02657616|"~     The central questions of the study can be summarized as follows:~      What stroke / death rates are the result of the use of the following treatment strategies: no~     anticoagulation with vitamin-k-antagonists (VKAs) or novel oral anticoagulants (NOACs),~     anticoagulation with VKAs and anticoagulation with NOACs (all). What other thromboembolic~     complication rates resulting from the use of these treatment strategies? What heavy bleeding~     rates resulting from the defined management strategies? The analysis is based on a data set~     of patients with atrial fibrillation (AF)(01/01/2010 - 30/06/2014). 2010 is used as the~     reference period and 01/01/2011-30/06/2013 as the inclusion period. The minimum observation~     time per patient is 12 months.~      Used is a data base of the AOK PLUS as well as the AOK Baden-Württemberg and AOK Bayern.~      The aim of the study is to compare clinical outcomes between the different treatment~     strategies (frequency of events and time to first event). The influence of alternative~     treatment strategies is measured on the basis of three different methodological approaches:~     unadjusted comparison of event council and time to first event between the defined patient~     groups; matched-pair comparison (propensity score matching) between the different groups of~     patients (treatment strategies) and multivariate analysis using time to event (Cox~     proportional hazards model) as the dependent variable.~   "
69473|NCT02657603|"~     This is a single center, randomized, blinded trial in healthy volunteers. The volunteers will~     receive bilateral placement of the new catheter corresponding to the adductor canal. Each~     volunteer will have a catheter placed in the adductor canal in both legs. The catheters are~     randomized to be placed either in the long-axis or short-axis plane of the adductor canal.~     Both catheters will be injected with local analgesics (LA). Allocation will be blinded to the~     volunteer and the investigator assessing sensory function. The volunteers will be sent home~     with the catheter in situ and return the following day. Injection with LA is repeated and~     sensory function is tested again. Furthermore catheter position is determined with ultrasound~     during injection. If sensory function is not affected by injection of LA then the catheter is~     visualized with ultrasound and repositioned followed by a second injection of LA and~     subsequent assessment of sensory function~   "
69474|NCT02657590|"~     This study aims at recording cardiac arrhythmias in patients after open heart surgery. The~     arrhythmias will be monitored during the entire first postoperative period, till six weeks~     after surgery.~   "
69475|NCT02657577|"~     WIC is a governmental program that provides healthy foods, nutrition education and referrals~     to other health and social services. With the goal of applying for a future grant to expand~     the dissemination of SmartLoss® within the WIC program, feedback (via focus groups) from the~     WIC employees and WIC recipients must be solicited to better understand the burden and~     barriers of integrating these kinds of programs and with WIC participants.~   "
69476|NCT02657564|"~     This study evaluates the changes of renal function after taking bowel cleansing agent~     polyethylene glycol for elective colonoscopy.~   "
69477|NCT02657551|"~     This research study is studying a targeted therapy as a possible treatment for thyroid~     cancer. A targeted therapy is a type of treatment that uses drugs or other substances to~     identify and attack specific types of cancer cells with less harm to normal cells.~      - The name of the study intervention involved in this study is regorafenib.~   "
69478|NCT02657538|"~     The aim of this study is to validate a near-infrared light transillumination device~     (DIAGNOcam, KaVo, Biberach, Germany) for interproximal enamel caries detection and compare it~     with the established diagnostic methods (visual examination and bitewing radiography). The~     aim is to avoid/reduce ionizing radiation for caries diagnostic purposes.~   "
69479|NCT02657525|"~     The purpose of this study is to investigate the demographic characteristics, clinical~     features, diagnoses and treatments of AECOPD hospitalized patients in China, and disease~     prognosis and its economic burden.~   "
69480|NCT02657512|"~     Rivaroxaban is a direct oral anticoagulant that target specifically activated factor X.~     Bleeding events related to rivaroxaban are the consequence of physiopathologic,~     pharmacokinetic issues or poisoning. Few results are available on the use of activated~     charcoal in rivaroxaban poisoning. Moreover, a recent study, in healthy subjects, shows that~     activated charcoal can reduce significantly exposition to apixaban (a direct oral~     anticoagulant of the same class). The objective of this study is to evaluate the effect of~     activated charcoal on rivaroxaban pharmacokinetics. It corresponds to a randomised open trial~     with an incomplete cross over design (3 occasions). It will enrol 12 healthy subjects. Four~     treatments modalities will be studied: rivaroxaban alone and rivaroxaban with activated~     charcoal administrated 2, 4 or 8 hours after rivaroxaban administration.~   "
69481|NCT02657499|"~     This innovative study will measure the impact of Affordable Care Act-sponsored Medicaid~     expansions on access to and utilization of community health center (CHC) services. Building~     on the investigators prior work that developed a robust community-based research~     infrastructure within the OCHIN community health information network, the investigator will~     utilize linked electronic health record data from the OCHIN network of >400 CHC clinics in 8~     states that expanded Medicaid coverage and 8 states that did not expand.~   "
69482|NCT02657486|"~     The purpose of this study is to study the activity and effects of BGJ398 on bladder cancer~     tumors that are confined to the lining of the bladder.~   "
69483|NCT02657473|"~     The purpose of this study is to evaluate the effect of tobramycin inhalation solution (TIS)~     once daily compared tot placebo in patients with non-CF bronchiectasis. The primary endpoint~     is a reduction of exacerbations of the disease during the treatment period. Next to this~     parameter the investigators expect to show a significant beneficial effect on lung function~     parameters, QoL, bacterial load of pathogens in sputum and tobramycin resistance.~   "
69484|NCT02657460|"~     The study is to investigate the anticancer effect and the related immunological mechanism of~     MTX-ATMPs in the treatment of malignant pleural effusion.~   "
69485|NCT02657447|"~     This study is a phase I, open label, randomized study to assess pharmacokinetics,~     biodistribution and radiation dosimetry of lutetium (177Lu) lilotomab satetraxetan~     (Betalutin®) radioimmunotherapy in patients with relapsed non-Hodgkin lymphoma. The study~     will also investigate the safety, toxicity and efficacy of Betalutin and pre-dosing.~   "
69486|NCT02657434|"~     This is a randomized, Phase III, multicenter, open-label study designed to evaluate the~     safety and efficacy of atezolizumab in combination with cisplatin or carboplatin + pemetrexed~     compared with treatment with cisplatin or carboplatin + pemetrexed in participants who are~     chemotherapy-naive and have Stage IV non-squamous NSCLC. Eligible participants will be~     randomized by a 1:1 ratio into 2 groups: Arm A (Atezolizumab + Carboplatin or Cisplatin +~     Pemetrexed) and Arm B (Carboplatin or Cisplatin + Pemetrexed). The study will be conducted in~     two phases: Induction Phase and Maintenance Phase.~   "
69487|NCT02657421|"~     The purpose of this single-arm observational study is to observe and document clinical~     outcomes of the OLIF25™ and OLIF51™ procedures in patients diagnosed with degenerative disc~     disease or degenerative scoliosis, and report the rate of adverse events of interest through~     the 24 months follow-up visit.~   "
69488|NCT02657408|"~     The primary and secondary objectives of the current study are the assessments of~     anti-inflammatory pharmacodynamic effects on segmental endotoxin induced inflammatory~     response after 4 weeks treatment with BI 1026706.~   "
69489|NCT02657395|"~     Can a fetal bovine derived membrane serve as an alternative to autogenous tissue for dental~     root coverage procedures.~   "
69490|NCT02657382|"~     The purpose of this study is to evaluate the blood flow to the heart during stress and assess~     changes in blood flow after psychological treatment in participants with coronary artery~     disease. The aims of the study are to assess the effects of heart rate variability (HRV)~     biofeedback (versus usual care) on global and regional myocardial blood flow (MBF),~     peripheral vascular function, and autonomic changes during mental stress.~   "
69491|NCT02657369|"~     The primary purpose of the study is to evaluate objective response rate ([ORR]: complete~     response [CR] and partial response [PR]) by investigator review in participants with~     anaplastic thyroid cancer (ATC) treated with lenvatinib.~   "
69492|NCT02657356|"~     This study assesses the safety and efficacy of bardoxolone methyl relative to placebo in~     patients with connective tissue disease-associated pulmonary arterial hypertension to~     determine the recommended dose range and evaluate the change from baseline in 6-minute walk~     distance (6MWD) following 24 weeks of study participation.~   "
69493|NCT02657343|"~     Participants that have breast cancer that has spread to other parts of the body, is positive~     for a protein called HER2, and has not responded to standard treatment. This research study~     is a way of gaining new knowledge about the combination of Ribociclib with other drugs as a~     possible treatment for this diagnosis.~   "
69494|NCT02657330|"~     This phase 1 first-in-human study evaluates safety and tolerability of SBP-101 in subjects~     with previously treated pancreatic ductal adenocarcinoma and will identify the maximum~     tolerated dose (MTD). In addition, this study will also assess the pharmacokinetic (PK)~     profile and preliminary efficacy of SBP-101.~   "
69495|NCT02657317|"~     This is a research study of an interdisciplinary pain management program for U.S. military~     veterans who served during the post-9/11 combat eras (e.g., Operations Iraqi Freedom [OIF],~     Enduring Freedom [OEF], New Dawn [OND]) presenting with chronic musculoskeletal pain related~     to military service with comorbid depression and/or posttraumatic stress disorder [PTSD]~     symptoms and/or mild traumatic brain injury. This study will test the efficacy of an~     interdisciplinary pain program compared to treatment as usual in the Veterans Health~     Administration on pain-related disability, opioid medication use, and pain coping.~   "
69496|NCT02657304|"~     Sleep apnea (SA) affects more than 4% from general population and is largely underdiagnosed.~     SA can increase the occurrence of cardiovascular, endocrine and metabolic events~     (particularly stroke, diabetes & obesity). CPAP is currently the Gold Standard treatment of~     SA and to prevent these events, with a major clinical benefit, long term adherence to CPAP is~     a significant problem where a significant rate of rejection and abundance after 6 months of~     treatment.~   "
72299|NCT02620605|"~     Study the effect of early cabergoline administration in prevention of occurrence or~     decreasing the severity of OHSS in patients undergoing intra cytoplasmic sperm injection.And~     its effect on oocyte maturation,fertilization and pregnancy rate..~   "
69498|NCT02657278|"~     Aim: To determine whether the lactate threshold during CPET is influenced by the presence of~     haemodynamically significant PAD.~      Assumption: Correction of haemodynamically significant PAD results in an increased LT,~     measured by CPET.~      Design: Prospective study Population: Thirty patients scheduled to undergo surgical or~     percutaneous treatment of iliofemoral arterial disease for intermittent claudication.~   "
69499|NCT02657265|"~     This study will compare two standard treatments in acute stable traumatic vertebral fractures~     (types A1 and A3.1 by Magerl Classification). The two treatments are as follows:~        1. SpineJack® system~        2. Conservative Orthopedic Management consisting of brace and pain medication.~   "
69500|NCT02657252|"~     It will be done a randomized triple-blind study comparing 0,2% polidocanol versus 75%~     hypertonic glucose of sclerotherapy in lower limbs´ telangiectasis. It will be included only~     adult women with reticular veins on the side of the thighs and mild venous insufficiency~     (CEAP 1). The primary endpoint will be efficacy, and secondary will be safety.~   "
69501|NCT02657239|"~     MOVE UP is a weight management program for adults 60-75 in community settings led by trained~     community health workers.~   "
69502|NCT02657226|"~     This study aims to examine the association between intensive monitoring of renal function~     (urine output, serum creatinine, and both) and outcomes among critically ill patients with~     and without Acute Kidney Injury (AKI)~   "
69503|NCT02657213|"~     The main objective is to evaluate the efficacy of sensor augmented pump (SAP) therapy with~     MiniMed 640G with SmartGuard activation in preventing hypoglycemia events in comparison~     sensor augmented pump (SAP) therapy with Minimed 640G without SmartGuard activation in type 1~     diabetic adults with an increased risk of hypoglycemia.~      The study should show:~        -  A reduction in the number of severe hypoglycemia, fewer hypoglycemic events and a~          reduction in the time spent in hypoglycemia six months in any group compared to~          Baseline.~        -  A complete prevention of severe and not severe hypoglycemia in the pump group Minimed~          640G + Enlite sensor with SmartGuard activation~   "
69504|NCT02657200|"~     KAP-study in Flemish midwives with intramural employment~   "
69505|NCT02657187|"~     Rocuronium block neuromuscular transmission at the neuromuscular junction, causing paralysis~     of the affected skeletal muscles. There have been several studies reported positive~     relationship between muscle mass and amount of neuromuscular junction. The purpose of this~     study is to find 50% effective dose and 95% effective dose of rocuronium according to muscle~     mass.~   "
69506|NCT02657174|"~     The association between low level laser and auricular acupuncture can be an alternative when~     conventional drugs are contraindicated or to reduce the quantity of these postoperative~     medications. The objective of this study is to evaluate the efficiency of low level laser at~     auriculotherapy points in reducing postoperative pain in lower third molar surgery. Eighty~     third molars surgeries will be performed in 40 healthy patients by a split-mouth design.~     Immediately after surgery, each side of the patient's mouth will be randomly treated with~     different regimens in a double-blind design: low level laser in auricular acupuncture points~     or simulation of its use. This treatment will be performed at 24 and 48 hours after surgery.~     The primary variable is the post-operative pain. The secondary variables are trismus, edema~     and local temperature. They will be assessed at baseline, 24 hours, 48 hours and seven days~     after surgery.The blood samples for analysis of systemic inflammatory cytokines (TNF-α,~     interleukin 1, interleukin 6 and interleukin 8) will be assessed at baseline and 24 hours~     after surgery.~   "
69507|NCT02657161|"~     Phase I clinical study for an investigational PIKA (Polyinosinic-Polycytidylic Acid Based~     Adjuvant) rabies vaccine comprising Inactivated and Purified Rabies Virus (IPRV) and the PIKA~     adjuvant. The primary objective of the study was to assess the clinical safety of the vaccine~     composition in healthy adult volunteers. The secondary objective was to evaluate the~     vaccine's efficacy based on an accelerated vaccine regimen.~   "
69508|NCT02657148|"~     The investigators have designed a single site, Phase IV open label, prospective observational~     clinical trial to compare the effect of immediate postpartum Nexplanon placement (IPP) versus~     standard postpartum contraceptive care (control) on consistent contraceptive use and rapid~     repeat pregnancy at 12 months postpartum in 200 opioid dependent (OD) women.~   "
69509|NCT02657135|"~     TEAM-TBI (Targeted Evaluation, Action, and Monitoring of Traumatic Brain Injury) is a~     research study that brings together TBI patients, advanced evaluation methods, and experts in~     a multi-faceted study to address the heterogeneity of TBI and to evaluate the effects~     self-help strategies might have on TBI outcomes.~   "
69510|NCT02657122|"~     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of~     single ascending doses and multiple ascending doses of the investigational drug TD-1473~     compared to placebo in healthy subjects.~   "
69511|NCT02657109|"~     4 consecutive days with volunteers between the first and fourth postoperative period of~     cardiac valve replacement. The volunteers are randomized into 2 groups: the Control Group~     submitted to cardiac rehabilitation protocol of the hospital where it will be conducted the~     study, which consists of respiratory and metabolic exercises. The second group, called Early~     Mobilization Group in addition to the aforementioned exercises will be added exercise in~     cycle ergometer. For the implementation of rehabilitation protocol in the early mobilization~     group volunteers will be placed in a sitting position in the bed with the backrest raised to~     45 °. The exercise in cycle ergometer will be held for 20 minutes on four consecutive days of~     active mode, the training load shall be such that the voluntary maintained throughout~     training a level of fatigue, maintaining level of heart rate predicted for age increased by~     70% and 1 w / cm2 every minute to keep the parameter within the standards. The evaluation of~     heart rate variability with the Polar monitor RS800CX brand model before surgery was~     performed first postoperative day and fifth postoperative day in the control groups and early~     mobilization.~   "
69512|NCT02657096|"~     In light of the controversy that are already approved but that however still exists regarding~     the efficacy and influence of the decontaminant tools for the management of Chronic~     Periodontitis (cp), the aim of this study was to evaluates, at 1 year follow-up, the~     post-treatment clinical parameters and immunological and gingival microbial profiles in~     patients with CP, treated by either SRP in addition to desiccant or SRP alone.~      The null hypothesis to invalidate was that, after a one year follow-up, there were no~     variations, in relation to clinical, anti-microbial and anti-inflammatory parameters between~     SRP + desiccant and SRP alone treatment.~   "
69513|NCT02657083|"~     The Study will compare treatment with Closed Loop (CL) system - DreaMed MD-AID to the~     standard treatment without computer algorithm decisions - SAP therapy in 20 children and~     adolescents with Type 1 Diabetes (T1D) during and after afternoon physical activity.~      The aims of the study are:~        -  to demonstrate that the use of DreaMed MD-AID is safe during physical activity~        -  to investigate the risk of hypoglycemia among children and adolescents with T1D after~          afternoon exercise during closed-loop control.~   "
69514|NCT02657070|"~     The purpose of this study is to determine if Reinforcement-Induced Movement Therapy (RIMT), a~     novel rehabilitation method that augments visuomotor feedback of movements of the patient in~     virtual reality, is effective in treating hemiparesis resp. learned non-use.~   "
69515|NCT02657057|"~     The purpose of this study is to determine if Transcutaneous Tibial Nerve Stimulation (TENS)~     is as effective as Percutaneous Tibial Nerve Stimulation (PTNS) as therapeutic option for~     subjects with Idiopathic Overactive Bladder (OAB) who have failed conventional therapy.~   "
69516|NCT02657044|"~     Endoscopic resection of adenomas in the colon is the cornerstone of effective colorectal~     cancer prevention. Endoscopic mucosal resection (EMR) is currently the most used technique~     for resection of large distal colorectal adenomas, however, maintains some important~     limitations. In large lesions, EMR can often only be performed in a piecemeal fashion~     resulting in relatively low R0-resection rates and high recurrence rates. Endoscopic~     submucosal dissection (ESD) is a newer procedure that is more difficult resulting in a longer~     procedural time, but is promising due to the high en-bloc resection rates and the very low~     recurrence rates. The aim of this multicenter randomized study is to compare EMR and ESD with~     regard to recurrence rates and radical (R0) resection rates, and to put this into perspective~     against the costs and complication rates of both strategies and the burden perceived by~     patients on the long term-term.~   "
69517|NCT02657031|"~     This study compares the efficacy of low dose Ketamine versus Compazine for the control of~     headache in patients presenting to the Emergency Department.~   "
69518|NCT02657018|"~     The purpose of this study is to investigate if MOBIGAME (an innovative, mobile phone-based~     game application) is suitable to increase daily physical activity and physical activity~     adherence as well as health parameters such as cardiorespiratory fitness, leg strength,~     glucose metabolism, vascular health and self-determination as well as health related quality~     of life in the course of a 24-week intervention in comparison to the control group receiving~     one-time lifestyle counseling.~   "
69519|NCT02657005|"~     Ewing sarcoma is characterized by genomic rearrangements resulting in over-expression of ets~     family transcription factors driving tumor progression. TK216 is designed to inhibit this~     effect by inhibiting downstream effects of the EWS-FLI1 transcription factor. This study is a~     first in human study of TK216 in subjects with Ewing sarcoma. The study is designed to~     establish initial safety and efficacy data to assess the potential of TK216 for further~     development.~   "
69520|NCT02656992|"~     Reduced exercise tolerance is commonly reported in patients with bronchiectasis. The purpose~     of this study is to evaluate the effects of high-intensity inspiratory muscle training~     (High-IMT) and sham High-IMT (control) on exercise capacity, respiratory muscle function~     (strength and endurance) and health related quality of life in patients with bronchiectasis.~   "
69521|NCT02656979|"~     The main purpose of this project is to investigate the blood flow of the ophthalmic artery~     (OA) in patients with ocular hypertension, high tension glaucoma and normal tension glaucoma.~     It is also to study the influence of the intraocular pressure difference on OA blood flow in~     the two first groups. Furthermore, the investigators want to understand the relationship~     between ocular dynamics, blood flow and structural alternations of the optic nerve head~     (ONH). The rationale behind the study is to improve knowledge of the pathogenesis of~     glaucoma.~   "
69522|NCT02656966|"~     In this prospective nonrandomized study the investigators are going to investigate whether~     auricular acupuncture with indwelling fixed needles is feasible for treatment of preoperative~     anxiety.~      Patients, scheduled for ambulatory gynecologic surgery, will be asked, if they wish to~     receive auricular acupuncture (AA) against preoperative anxiety. The patients who will not~     wish AA, will be asked to take part in questioning (State-Trait-Anxiety-Inventory (STAI)~     questionnaire) and will form the control group. The preoperative anxiety using STAI, as well~     as the duration and quality of sleep on the night before surgery, the incidence of side~     effects, blood pressure and heart rate will be the outcome measures in this study.~   "
69523|NCT02656953|"~     The aim of this study is to investigate the impact of wearing visual display units (VDU)~     lenses versus progressive lenses on musculoskeletal and visual complaints in VDU workers with~     work related neck complaints. This will be evaluated by means of questionnaires (Neck~     Disability Index and Visual Fatigue Questionnaire), muscle tone, elasticity and stiffness,~     pressure pain threshold and 2D video analysis of head posture during a VDU task.~   "
69524|NCT02656940|"~     The purpose of this study is to determine whether the modulation of dietary lipids are~     effective in the treatment of obesity and comorbidities.~   "
69525|NCT02656927|"~     The purpose of this randomized controlled study is to evaluate psychological variables,~     mindfulness, and pain in the context of a specialized yoga program for individuals with SCI.~     Participants will be randomized to either a wait-list control condition or to a specialized~     yoga program condition.~   "
69526|NCT02656914|"~     The purpose of this study is to evaluate the clinical efficacy of the drug associations in~     the treatment of common cold~   "
69527|NCT02656901|"~     This study is designed to test the hypothesis that closed loop system reduces post operative~     cognitive dysfunction incidence 15 min after anesthesia more than desflurane, sevorane, total~     intravenous anesthesia manually guided by bispectral index in urologic surgical patients.~      The secondary aim is to evaluate the postoperative cognitive impairment in in elderly vs~     younger surgical patients.~   "
69528|NCT02656888|"~     The purpose of this study is to evaluate the clinical efficacy of the drug associations in~     the treatment of common cold symptoms.~   "
69529|NCT02656875|"~     Patients with moderate to severe pain caused by medical conditions or surgery, who require IV~     opioid therapy may be enrolled in this open label safety study. Patients will be treated with~     TRV130 by IV bolus, PCA (patient-controlled analgesia) administration, or both, as determined~     by the investigator, for a duration not to exceed 14 days.~   "
69530|NCT02656862|"~     Fever is one of the main reasons for outpatient consultations in sub-saharan Africa.~     Following the introduction of malaria RDTs, clinicians face a high number of malaria-negative~     patients for whom they do not have a clear diagnosis. Through clinical history and~     examination, acute fever patients are categorized into: acute respiratory infections, urinary~     tract infections and other focal infections, diarrheal fevers and undifferentiated fevers.~     The latter being patients where no focal source of infections can be found during the~     consultation visit. In this proposal, the investigators focus on these acute undifferentiated~     fevers in an outpatient clinic.~      These fevers have the challenge of few point-of-care tests (POCT) available for the~     clinicians to identify the etiology of fever and guide treatment in resource-limited~     countries. As a consequence, over-prescription of antibiotics has increased. In order to~     improve patient outcomes while supporting judicious use of antimicrobials, there is an urgent~     need to change the management of febrile patients in low-income countries. This can only be~     achieved by providing evidence-based clinical guidelines for the management of these acute~     febrile patients. To develop such guidelines, epidemiological data on etiologies of~     undifferentiated fever need to be generated. The investigators will evaluate pathogen~     infection (such as dengue, chikungunya and others) in 640 patients ≥ 2 years old with acute~     undifferentiated fever. To evaluate the existence of aspecific and subclinical infections and~     co-infections, the investigators will also test a subsample of 200 patients with ARI, UTI,~     diarrheal fever and malaria. The investigators expect to have as main results: proportions of~     each syndrome among fever patients, key pathogens associated with undifferentiated fever and~     their clinical presentation and demographic characteristics.~   "
69531|NCT02656849|"~     This research study is studying whether a new experimental cancer study drug BAY 1000394 will~     be helpful in treating solid tumor cancer with an abnormality in one of the following genes:~     Mcl-1, Myc or CCNE.~   "
69532|NCT02656836|"~     The overall objective of the study is to scope the self-management for self-monitoring~     glaucoma using home tonometry.~   "
69533|NCT02656823|"~     Multicenter study to assess the survival and the success rates of six short implants (ANKYLOS~     C/X 6.6 mm) in the edentulous maxilla supporting fixed full-arch bridges after 5 years in~     function.~   "
69534|NCT02656810|"~     The purpose of this study is to compare the pharmacokinetics (blood levels) of two~     teriparatide products, PF708 and Forteo, in healthy subjects.~   "
69535|NCT02656797|"~     Comparison between placebo gel treatment to topical liposomal amphotericin B gel treatment~     for cutaneous leishmaniasis of Leishmania species major and tropica.~   "
69536|NCT02656784|"~     This is a sample made up of ninety-six adult individuals of both sexes to be divided into~     three groups: the experimental group of thirty-two patients with OCD who will be undergone~     Trial-Based Cognitive Therapy; the gold standard, with thirty-two people with OCD subject~     Exposure and Response Prevention and the control group of thirty-two healthy individuals.~     Interviews and therapeutic intervention occur in private practices researchers or medical~     schools accredited by UESPI.~      Experimental group: Will be eligible adults of both sexes with educational level equal to or~     higher education complete primary, aged between 18 and 60 years with OCD diagnosis confirmed~     according to criteria DSM-IV (APA, 1994). It is going to be excluded patients who had~     previously undergone treatment behavioral psychotherapy or cognitive-behavioral approach.~   "
69537|NCT02656771|"~     The purpose of this study is to measure quantitatively the implant stability and implant~     related remodeling of the periprosthetic femoral bone of the new uncemented Echo® Bi-Metric®~     Full proximal Profile total hip arthroplasty (THA) stem, and compare it to the classical~     uncemented Bi-Metric® Porous Primary THA stem by measuring migration of the stem assessed by~     model-based radiosteriometric analysis (MB-RSA) and measuring the periprosthetic adaptive~     bone remodeling assessed by dual-energy x-ray absorptiometry (DXA).~   "
69538|NCT02656758|"~     The investigators intent to recruit 80 attention deficit hyperactivity disorder families. The~     attention deficit hyperactivity disorder families had received executive function training~     one year before.They will be randomized to intervention group and control group using a block~     randomization design. The intervention group will participate in intensive executive function~     training immediately,while the control group will receive executive training after 3 months.~   "
69539|NCT02656745|"~     The Sponsor is doing a research study to assess the effects of a smartphone program designed~     to help users smoke less and eventually quit. When participants join, their involvement in~     the core study will last 8 weeks. After 8 weeks, they will have the option to continue using~     the program to guide their quit journey or participate in follow-up research.~   "
69540|NCT02656732|"~     The present randomized, controlled, parallel-grouped trial included twenty patients (aged 20~     to 54 years) suffering from Miller's class I or II gingival recession. Patients were randomly~     assigned into two equal groups; control group; the coronally advanced flap with the~     subepithelial connective tissue graft (CAF+SCTG) or the test group; coronally advanced flap~     with amnion chorion allograft membrane (CAF+AC).~   "
69541|NCT02656719|"~     Trial is a randomized study to compare between ultrasound guided percutaneous tracheostomy~     and bronchoscopy guided percutaneous tracheostomy.~   "
69542|NCT02656706|"~     Effective adjuvant treatment can increase cure in patients with high-risk resected melanoma.~     High dose interferon is a standard of care in the adjuvant setting but is highly toxic and~     marginally effective. The combination of ipilimumab and nivolumab is the most active regimen~     in patients with advanced melanoma so there is clear rationale to test this regimen in the~     adjuvant setting. Investigators are testing if nivolumab 3mg/kg every 2 weeks with 1mg/kg~     ipilimumab every 6 weeks in the high risk adjuvant setting. The duration of therapy will be~     six months.~   "
69543|NCT02656693|"~     The goal of this project is to adapt an evidence-based online weight management program and~     integrate it with population management support from primary care practices. Investigators~     then will conduct a three-arm, cluster-randomized trial to compare the effectiveness of 1)~     the combined intervention (online weight management program plus population management~     support) with 2) the stand-alone online weight management program and with 3) usual care,~     among overweight and obese primary care patients with type 2 diabetes or hypertension. The~     specific aims are:~        1. a. To adapt an online weight management program and integrate it with population~          management support, incorporating input from patients, primary care clinicians, and~          other stakeholders; afterward, investigators will acquire feedback on the positive and~          negative aspects of the intervention.~           b. To compare the effectiveness of the combined intervention (online weight management~          program plus population management support) with the stand-alone online program and with~          usual care.~           Hypothesis 1: The combined intervention will lead to greater weight loss at 12 months~          compared with the stand-alone online program and with usual care.~        2. To identify mediators of the combined intervention and the stand-alone online program.~           Hypothesis 2: The effects of the combined intervention and the stand-alone online~          program on weight loss will be mediated by patients' level of engagement, changes in~          self-efficacy, and changes in diet and physical activity.~        3. To explore whether the effectiveness of the combined intervention and the stand-alone~          weight management program varies by patient characteristics.~      Hypothesis 3: The interventions will be more effective among patients who are younger, white,~     and higher socioeconomic status, although the population management strategy may help to~     reduce these differences.~   "
69581|NCT02656199|"~     We will investigate whether measurement of the change in thickness of the diaphragm during~     the respiratory cycle by ultrasound can predict extubation success in a 48 hour window. We~     will also asses whether this is only possible on low levels of pressure support as has been~     shown previously, or if this technique retains its predictive power at higher levels of~     pressure support.~   "
69544|NCT02656680|"~     In a pilot randomized trial of 160 obese participants, investigators will test the~     feasibility of a behavioral weight loss program delivered entirely via Facebook. Participants~     will be randomized to a condition in which they will be able to invite their friends, or a~     condition with study participants only. All participants will receive behavioral counseling~     via the private Facebook group from the coaches who are present on the network daily.~     Participants will track their diet and exercise via a free commercial mobile app.~   "
69545|NCT02656667|"~     The aim of this study is to evaluate the effectiveness of quadriceps strengthening with~     neuromuscular electrical stimulation versus cycle ergometer as part of pulmonary~     rehabilitation program , in patients with severe or very severe COPD , according to GOLD with~     BODE index ≥ 5 .~   "
69546|NCT02656654|"~     Early and adequate fluid resuscitation (< 6 hours) in patients with circulatory failure is~     essential but may exacerbate oedema, which may itself: 1) aggravate pulmonary lesions and~     prolong mechanical ventilation, 2) aggravate organ failure and 3) increase mortality notably~     in patients with acute renal failure. Improving fluid balance is considered crucial in the~     management of patients in septic shock, but the efficacy of the measures currently proposed~     (diuretics associated or not with albumin and/or dialysis) is controversial. The~     investigators hypothesize that a whole-body compression using a body bandage could reduce~     capillary leakage and thus lead to faster restoration of a normal transmural pressure~     gradient in postcapillary venules and improve venous return.~      This is the first study to evaluate mechanical compression using a body bandage to reduce~     oedema in septic shock.~      To do this, a whole-body compression will be set up within the 12 hours following admission.~     Water balance will be monitored daily throughout the duration of the compression and vital~     status of patients will be search at 7 days, 28 days and 90 days.~   "
69547|NCT02656641|"~     This study will assess the effects of client feedback, using the Patient Health Questionnaire~     - 9 and Generalized Anxiety Disorder 7-Item Scale, on depression and anxiety in individuals~     undergoing brief psychotherapy. Client feedback allows therapists to monitor treatment~     progress in real time. Identifying an easily accessible treatment intervention, which~     utilizes commonly used scales, that potentially enhances the effect of brief psychotherapy~     and improves treatment outcomes is a valuable endeavor with clear implications for therapy~     practices. It is hypothesized that clients who complete these scales each session will show~     greater symptom improvement than clients who do not complete the scales.~   "
69548|NCT02656628|"~     The purpose of this multi-center patient registry is to obtain first clinical results and to~     assess short and mid-term clinical outcome data of patients treated with DLS.~   "
69549|NCT02656615|"~     To assess activity of abiraterone-re-challenge in patients with advanced prostate cancer and~     prior response to abiraterone.~   "
69550|NCT02656602|"~     Better patient education prior to colonoscopy improves adherence to instructions for bowel~     preparation and leads to cleaner colons. The hypothesis of this trial is that computer~     assisted instruction (CAI) using video and 3D animations can maximize the effectiveness of~     nurse counselling and consequently improves bowel cleanliness. Furthermore, CAI will~     positively influence the patient experience.~      Adults referred for colonoscopy were included in a Dutch large volume endoscopy unit.~     Exclusion criteria were illiteracy in Dutch and audiovisual handicaps. Patients were~     prospectively divided into two groups, one receiving nurse counselling and one receiving CAI~     and a nurse contact before colonoscopy. The main outcome, cleanliness of the colon during~     examination, was measured with the Ottawa Bowel Preparation Scale (OBPS) and the Boston Bowel~     Preparation Scale (BBPS). Patient comfort and anxiety were assessed at multiple time points:~     directly after the instruction and one hour before colonoscopy. Comfort was rescored 2 hours~     after colonoscopy. We also tested knowledge and comprehension one hour before colonoscopy.~     Statistical analyses included Mann-Whitney.~   "
69551|NCT02656589|"~     This projective observational study is planned to enroll more than 300 advanced breast cancer~     patients, who were proved as Her-2 positive using fluorescence in situ hybridization (FISH)~     and / or immunohistochemistry, and 100 healthy donors as control. Before treatment, the~     plasma microRNA will be collected and detected by microRNA extraction kit and quantitative~     polymerase chain reaction (qPCR), respectively. After analyzed their microRNA expression by~     microRNA predictive model, previously reported by our team, all of enrolled patients will be~     classified as probable sensitive group or probable resistant group. Herceptin combined~     with other chemotherapy will be the backbone of salvage treatment and used for at least 3~     months; the change of local masses and metastasis lesions after treatment will be documented~     to evaluate the response. Based on these results, investigator aim to construct a~     mathematical predictive model by analyzing the correlation of baseline microRNA expression~     level and the prognosis of patients. And a diagnosis microRNA kit will be planned and~     manufactured~   "
69552|NCT02656576|"~     Multicentre prospective study of concordance between two tissue sampling modes (smear /~     biopsy), which applies the same diagnostic method (PCR).~   "
69553|NCT02656563|"~     This is a multicentre, phase II, randomized, open label study to evaluate the efficacy and~     safety of monthly Radium 223 in prolonging the off treatment interval of men with localized~     prostate cancer receiving intermittent androgen ablation therapy for a rising PSA~     post-radiation or post-prostatectomy, who are at high risk for occult metastases.~   "
69554|NCT02656550|"~     This study aims to investigate the treatment of absolute uterine infertility (AUI) due to~     congenital or surgical absence of a uterus or presence of a nonfunctioning uterus. The~     investigators will follow a model based on a Swedish study to enroll 10 women with~     functioning ovaries and successfully transplant the uterus from either a living or cadaveric~     donor, with the goal of live birth after transplantation.~   "
69555|NCT02656537|"~     In this clinical investigation, the safety, feasibility and performance of the novel EnSite™~     HD Grid Catheter mapping system for advanced high-density three-dimensional mapping will be~     studied in patients undergoing catheter ablation procedures for the treatment of~     non-paroxysmal atrial fibrillation (AF) or left atrial tachycardia (AT).~   "
69582|NCT02656186|"~     The purpose of this study was to determine the improvement in nutritional status, especially~     in the level of insulin-like growth factor-1 (IGF-1) and its relationship with changes in the~     circulating cytokine levels, after providing extra protein and energy contents to~     community-dwelling older adults at risk of undernutrition.~   "
69556|NCT02656524|"~     The study aims to evaluate use of regorafenib in clinical practice in Hungary. The study~     should provide information about clinical characteristics of Hungarian regorafenib patients~     as well as information about safety and efficacy of regorafenib in Hungarian patients with~     metastatic colorectal cancer. This much needed data is required by the National Health~     Insurance Fund in order to accept regorafenib into the regular reimbursement system. This~     study is proposed to be based on patient data from the Hungarian National Health Insurance~     Fund's Database. Data to be analyzed includes patient demography and baseline tumor~     characteristics, overall survival, time to treatment failure, duration of treatment, average~     dose and dose modifications, and adverse events. Further, treatment costs will be estimated.~   "
69557|NCT02656511|"~     The purpose of this study is to identify and provide immediate antiretroviral therapy to a~     cohort of HIV-infected individuals with very early HIV infection (estimated date of infection~     within the last 90 days). The primary aim of the study is to evaluate whether initiation of~     dolutegravir plus emtricitabine/tenofovir during acute/early HIV infection leads to~     protection of CD4+ T cells and other immune cells in the peripheral blood and lymphoid tissue~     from infection.~   "
69558|NCT02656498|"~     This is a cross-sectional and longitudinal study to evaluate the clinical utility of~     [18F]THK-5351 positron emission computed tomography in cognitively healthy volunteers, mild~     cognitive impairment (MCI), Alzheimer's disease (AD) and other neurodegenerative patients.~   "
69559|NCT02656485|"~     This is a single center, randomized, double-blind, placebo-controlled study in subjects with~     acne vulgaris.~   "
69560|NCT02656472|"~     The purpose of this study is to compare anti-inflammatory effects of two anti-fibrinolyntic~     drugs (Tranexamic acid versus Epsilon-aminocaproic acid) in pediatric patients undergoing~     pediatric cardiac surgery.~   "
69561|NCT02656459|"~     The purpose of this study is to examine the immune response to traumatic injury and~     subsequent infections in critically ill adults. Traumatic injuries lead to severe~     dysregulation of the immune system, and predispose to severe infections. Diagnosing these~     infections in a timely manner is paramount in reducing morbidity and mortality, but diagnosis~     is made difficult by the inflammatory response to trauma. The main purpose of the study is to~     prospectively test the diagnostic power of the expression of an 11-gene set which the~     investigators recently published (Sweeney et al., Sci Transl Med, 2015). Since the timing of~     an acquired infection cannot be determined a priori, this study is designed to be a~     longitudinal examination of a cohort of traumatically injured adults. The investigators will~     draw blood at regular intervals, as well as at day of diagnosis of infection for any patient~     that are diagnosed with an infection. The investigators will then assay the blood for gene~     expression levels post hoc, and correlate the molecular profiles with clinical information to~     establish a prospective estimate of diagnostic power.~   "
69562|NCT02656446|"~     The purpose of this study is to determine if a handheld ultrasound device helps in the~     placement of labor epidurals by studying the accuracy of the Accuro Handheld Ultrasound~     device compared to a standard ultrasound machine.~   "
69563|NCT02656433|"~     50 children between 4 and 7 years old with moderate to severe motor impairment, 50% males 50%~     females will participate in an interventional study in two groups: placebo and experimental~     group.~      Placebo group will only receive traditional treatment with physiotherapy and the Experimental~     or tRNS Group will receive physiotherapy plus tRNS BrainNoninvasive Stimulation.~   "
69564|NCT02656420|"~     This study will examine the extent to which lower doses of a broccoli-derived beverage~     enhance the detoxication of air pollutants excreted in urine as compared to an maximal dose~     shown to be effective previously.~   "
69565|NCT02656407|"~     A wide spectrum of methods is used to image brain activation in vivo. It can be directly~     detected by neurons electrical activity imaging (cortical simulation mapping, calcium~     imaging, voltage sensitive dyes) or indirectly by imaging hemodynamic changes induced by the~     neurovascular coupling in the vessels surrounding the activated neurons (intrinsic optical~     imaging, photoacoustic imaging, positron emission tomography (PET), functional magnetic~     resonance imaging (fMRI)).~      Ultrasound as the potential to complement these functional imaging techniques at low cost.~     Ultrasound imaging can do real-time in-depth imaging of brain. However, its use to imaging of~     major vessels has been limited until now due to its poor sensitivity. To overcome this~     limitation functional ultrasound (fUS) was developed in Institut Langevin since 2011. This~     technique enables high spatio-temporal resolution imaging of whole-brain microvasculature~     dynamics in response to brain activation without the need of contrast agent.~      This fUS method relies on a new power Doppler imaging sequence sensitive enough to detect~     blood flow in most of cerebral vessels (arterioles, big venules and larger vessels).~     Repeating the acquisition of such ultrasensitive Doppler images over time enables to follow~     flow dynamics in such vessels modulated by local neuronal activity.~      Applied to the rat brain, fUS was proved able to map brain activation at high spatiotemporal~     resolution and high signal to noise ratio. The aim of this study is now to apply fUS on human~     brain in intraoperative condition.~      The main objective of this study is to find activation maps through intraoperative~     ultrasensitive Doppler compared to gold standard cortical simulation mapping and functional~     MRI.~      Secondly the investigators want to test sensitivity of this new Doppler mode. fUS method will~     be used for different types of stimuli and intensity and the investigators will do some~     control acquisitions. Blood vessel density observed with a conventional Doppler will be~     compared to the one measured with the ultrasensitive Doppler to prove that this new Doppler~     mode enhance micro vessel visualization.~   "
69566|NCT02656394|"~     To evaluate the safety and efficacy of 0.5% GL101 topical gel administered twice daily for 28~     days in ameliorating adverse ocular side effects in patients under ongoing treatment with~     glaucoma medications.~   "
69567|NCT02656381|"~     Background:~      Uveitis is a serious eye disease that can cause vision loss. Treatment sometimes causes~     serious side effects or does not work. Researchers want to learn more about uveitis and why~     some people develop it.~      Objective:~      To learn clinical and genetic factors that may make people develop uveitis and influence how~     they respond to treatment.~      Eligibility:~      People ages 8 and older who have uveitis, scleritis, inflammatory eye disease, or a disease~     related to eye inflammation~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Eye exam~      Participation lasts up to 10 years. The clinic visit schedule varies depending on~     participants eye disease:~      Baseline visit with annual follow-ups~      Baseline visit, visits at months 3 and 6, and annual follow-ups~      Another schedule set by the researcher~      Depending on participants eye disease, tests during each visit could include:~      Fluorescein angiography or indocyanine green angiography: Dye is injected through a needle in~     the arm~      and flows through the blood vessels in the eye. A camera takes pictures of the eye.~      Electroretinography: Participants sit in the dark with their eyes patched.~      After 30 minutes, numbing drops and contact lenses are put in the eyes. Then, the retina is~     stimulated with flashing lights.~      Perimetry: Participants look into a bowl or lens and press a button when they see a light.~      Conjunctival or corneal biopsy, or skin biopsy: A small piece of tissue is removed.~      Anterior chamber tap: A needle enters the eye to remove fluid.~      Blood and urine tests~      Saliva, stool, hair, or tear samples~      Cotton swab of the inside of the cheek.~      During the study, participants may need immunosuppressive treatment, such as drugs or~     injections in or around the eyes depending on their disease.~   "
69568|NCT02656368|"~     SEBORRHEAMEDIS Face Cream is a barrier-based, non-steroidal cream. The cream includes plant~     extracts The cream was designed to manage the symptoms of facial Seborrheic dermatitis~     symptoms such as erythema, scaling and pruritus.~   "
69569|NCT02656355|"~     Gait initiation (GI) difficulty is common in people with Parkinson's disease (PD). Studies~     showed that the GI difficulty was related to impaired anticipatory postural adjustments~     (APA). In healthy people, two phases of APA related center of pressure (COP) shifting were~     observed before GI. In people with PD, delay and decrease amplitude of APA or abnormal~     multiple APAs were observed during GI.~      Conventional balance tests record the maximum displacement and/or velocity of Center of~     pressure (COP). However, these variables could not show the performance of APA. Previous~     studies suggested that balance and gait initiation were controlled by separate neural~     circuitries. This could explain why the conventional COP measurement did not correlate to GI~     very well.~      It is important to develop GI related APA tests and trainings. Researchers found that a~     perturbation applied before the COP displacement during GI could delay both GI and APA. This~     indicates that COP displacement has APA components. Our pilot study shows that there is a~     reverse direction of COP displacement before voluntary COP displacement, suggesting the~     existence of APA.~      This three year project will evaluate the relationship of the APA of voluntary COP~     displacement and the APA of GI, establish the APA test for PD, and investigate the effect of~     APA training on GI in people with PD.~      In the first year, 20 people without disability will be recruited. The APA before voluntary~     COP displacement test, APA before GI, and gait performance will be evaluated. In the second~     year, 15 people with PD and 15 healthy people will be recruited. Subjects will receive GI~     test, gait test, and APA before voluntary COP displacement test. The relationship between~     different types of APA will be established for PD and healthy people. In the third year, 30~     people with PD will be randomized into APA training group, balance group, and control group.~     The different training effect will be evaluated especially on GI, gait performance, and~     freezing of gait.~      This project will advance the knowledge of mechanism of GI difficulty. The result of this~     project can be applied to clinical rehabilitation of people with GI difficulty.~   "
69570|NCT02656342|"~     In this randomized controlled trial (RCT) the investigators experimentally test if patients~     with Obsessive-Compulsive Disorder (OCD) who have received treatment with exposure and~     response prevention (ERP), but either relapsed or not responded, profit from the combination~     of concentrated exposure based treatment (cET) and the NMDA-agonist (N-methyl-d-aspartate)~     d-cycloserine (DCS), targeting fear relevant areas in amygdala and pre-frontal cortex.~      The project expects to demonstrate a significant improvement in all groups, and anticipate~     that a higher proportion of the patients who receive DCS will show a better long-term gain~     from the treatment, as compared to the placebo group at follow-up (3 mon, 12 mon, and 5 years~     after treatment). In addition, the project will highlight changes in depression, sleep,~     global functioning, quality of life, work and social status. Changes in medication and use of~     health care will be included and related to the main objective of the study.~   "
69571|NCT02656329|"~     This is an event-driven Phase IIIb, multicentre, randomised, clinical study to demonstrate~     the efficacy of AdreView™ imaging for appropriately guiding the decision of implantable~     cardioverter defibrillator (ICD) implantation, in New York Health Association (NYHA) class II~     and III heart failure patients with 25%≤left ventricular ejection fraction (LVEF)≤35%, and in~     particular, for identifying patients who are at low risk for sudden cardiac death and who~     would not benefit, or may suffer harm, from implantation of an ICD device.~   "
69572|NCT02656316|"~     The current RCT aims to establish the therapeutic potential of tDCS for freezing of gait~     (FOG) and motor-cognitive dysfunctions in PD. As noted, FOG is often unresponsive to~     pharmacological and other treatments, especially in the advanced stages of the disease. While~     it is likely that tDCS will provide symptomatic relief, we will also explore, via secondary~     outcomes, the potential for tDCS to modify disease progression. Support for this possibility~     stems from the likely mechanisms of action of tDCS.~   "
69573|NCT02656303|"~     This is a multi-center, open-label, study to evaluate the safety and efficacy of ublituximab~     (TG-1101) in combination with TGR-1202 for patients who have progressed on treatment arms~     previously enrolled in Protocol UTX-TGR-304~   "
69574|NCT02656290|"~     The objective of this trial is to assess the safety and effectiveness of the Edwards~     Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five~     years or older requiring replacement of their native or prosthetic pulmonary valve.~   "
69575|NCT02656277|"~     This study is a randomized controlled trial using Duke patients to test, compared to the~     standard of care, a questionnaire and statistical model used to determine how patient~     preference regarding shoulder pain, physical limitations, physical therapy, recovery period,~     prognosis, and cost impact choice of surgical versus non-surgical intervention.~      Phase 1 of this study is the initial testing of the instrument and involves a small group of~     up to 10 individuals who will partake in one-on-one interviews while completing the Shoulder~     Injury Survey to provide feedback. In Phase 2 of this study, 200 subjects will be randomized~     to receive either the Decision Tool or the standard Information on Shoulder Dislocation~   "
69576|NCT02656264|"~     The purpose of this study is to determine the effects of whether urgent or elective cesarean~     section on the occurrance of chronic pain.~   "
69577|NCT02656251|"~     The aim of the study is to compare the effect of a suspension containing chlorhexidine and~     alcohol and another one containing clorhexidine with no alcohol in dynamic of the subgingival~     biofilm formation versus a Placebo suspension. The initial subgingival biofilm formation will~     be evaluated by means of Plaque Free Zone (PFZ).~   "
69578|NCT02656238|"~     The New International CTEPH Database is a prospective, observational multi-center disease~     registry run by the International CTEPH Association (ICA), which will collect data in chronic~     thromboembolic pulmonary hypertension (CTEPH) patients worldwide. The registry will run for~     approximately 5 years. Its objective is to provide an overview on epidemiology of CTEPH, mode~     of diagnosis and treatment approaches worldwide as well as determinants of long-term outcomes~     as measured by New York Heart Association (NYHA) functional class and survival.~      The data collected will improve the knowledge and understanding of this condition, support~     the further development of diagnosis and treatment guidelines for patients with CTEPH, and~     contribute to improving patient care in the long-term.~   "
69579|NCT02656225|"~     The prevalence of postpartum anemia is a great threat for maternal and infant health without~     timely and effective treatment. Oral iron therapy has been used for centuries as a treatment~     of anemia, however, it is noteworthy that treatment with oral iron might have a limited, and~     even a harmful role in some clinical scenarios. Ejiao compound is composed with donkey-hide~     glue, Ginseng, Codonopsis pilosula, prepared rhizome of rehmannia, and crab apple, which has~     been widely used in the treatment of various types of anemia in China for decades and might~     be a potentially effective therapy for postpartum anemia. Recently, studies involving animal~     subjects have helped shed light on its mechanism of action.~      In this study, the investigators aimed to conduct a randomized controlled trial to assess the~     efficacy and safety of Ejiao compound comparing with oral iron in the treatment of mild~     postpartum anemia with or without iron deficiency.~   "
69580|NCT02656212|"~     This will be a double-blind, randomized, placebo-controlled, single dose study of (+)-~     epicatechin with one 30mg dose/day for a total of 7 days~   "
69586|NCT02656134|"~     Background and study aim The relative risks of duodenal adenocarcinoma and ampullary~     carcinoma in Familial Adenomatous Polyposis (FAP) have been estimated 100 to 330 times higher~     than in general population. However risk factors, including a genotype-phenotype association~     for duodenal cancer in FAP has not been fully understood. The aim of this study is to~     determine risk factors associated with the development of advanced duodenal polyposis and~     ampullary adenomas in colectomized patients with FAP.~   "
69587|NCT02656121|"~     Recently, a special emphasis has recently been directed to the potential role of vitamin D~     and some regulatory peptides (e.g. adipokines and follistatin) and their associated metabolic~     roles and genetic factors in the development of PCOS and its related co-morbidities. The aim~     of this study is to compare the effect of vitamin D supplementation therapy and Metformin~     therapy on plasma concentrations of adipokines (ghrelin, resistin and adiponectin),~     follistatin and activins in participants diagnosed with PCOS.~   "
69588|NCT02656108|"~     This is a comparative study which will be conducted in Ain Shams University Maternity~     hospital to assess the individual and specfic role of controlled cord traction as a part of~     active management of third stage of labor~   "
69589|NCT02656095|"~     This study plans to learn more about measuring Lipoprotein lipase (LPL) activity in humans.~     LPL is an enzyme in the breakdown of certain types of fats into smaller parts. Lipoprotein~     lipase deficiency (LPLD) is a very rare genetic disorder in which lipoprotein enzyme is no~     longer functional. This can cause conditions known as high triglycerides in the blood and~     inflammation of the pancreas.~      Investigational medications to treat LPLD are currently being developed. In order to see if~     these medications are effective, it is necessary to be able to accurately measure LPL~     activity in humans.~      LPL activity has been successfully measured in animal models after giving heparin. Heparin is~     a blood thinner which is approved by the FDA. It is originally used to prevent blood clots.~     This study will administer heparin to healthy adults through intravenous infusion (IV). Blood~     samples will be collected before and after the infusion to test LDL levels.~      The purpose of this study is to develop a cheap, more reliable standard for assessment of~     LPLD in patients~   "
69590|NCT02656082|"~     The purpose of this study is to determine whether Etanercept which is given through~     intradermal injection is effective in the treatment of discoid lupus erythematosus (DLE).~      The investigators also would like to develop new tests to measure skin inflammation by~     scanning the affected skin using optical coherence tomography (OCT), thermography and laser~     doppler imaging (LDI) and taking photographs of the rash (to be done before and after~     treatment). If the findings from these new tests are similar to the ones from taking a sample~     of skin (biopsy), then the latter (which is an invasive test) can be avoided.~   "
69591|NCT02656069|"~     This is a blinded, randomized crossover study to compare the safety and efficacy of G-Pen™~     (glucagon injection) to Lilly Glucagon (glucagon for injection [rDNA origin]) for~     hypoglycemia rescue of adult patients with type 1 diabetes.~   "
69592|NCT02656056|"~     The consumption of fermented soy foods can alter the human microbiome and may confer health~     benefits. Researchers propose a line of inquiry to assess the effects of Q-Can Plus (QC)~     fermented soy beverage in humans, assessing immunological, microbiological, and clinical~     parameters.~   "
69593|NCT02656043|"~     Phase 1/2 study enrolling 48 healthy volunteers in Phase 1 followed by 150 subjects with acne~     vulgaris in Phase 2.~   "
69594|NCT02656030|"~     Recent studies indicate that the patients with chronic neck pain present decreased activation~     and weak of neck muscles, especially deep flexor and extensor muscles. Alterations of deep~     are associated with pain and impairment of neck function in chronic neck pain.~      Exercise is known to be an important component of treatment programs for patients with neck~     pain. Recently, many studies have focused on specific training on deep cervical muscles,~     especially deep cervical flexor and deep cervical extensor muscles.Numerous studies using~     cranio-cervical flexor exercise as a treatment have revealed reduction on pain, neck~     disability, changing in activation of deep cervical flexor muscles. Further, the cervical~     extensor muscles are believed to be equally important for the rehabilitation of patients with~     neck pain. However, the retention effect of semispinalis cervicis exercise is unknown.~     Therefore, the semispinalis cervicis exercise still need more evidence to support clinically~     effects.~      The current study will be conducted to fill the gap of the previous study in immediately,~     short, and long term effects of semispinalis cervicis exercise in chronic neck pain.~   "
69595|NCT02656017|"~     This study will test to see if metformin is safe and if it is tolerated compared to placebo~     in adult Autosomal Dominant Polycystic Kidney Disease (ADPKD) patients with beginning stages~     of chronic kidney disease. We will also measure its effect on progression of kidney disease~     as reflected in the kidney size and the kidney function, along with its effect on kidney pain~     and quality of life.~   "
69596|NCT02656004|"~     The essential eucalyptus oil has therapeutic potential in the cardiovascular system, with~     possibilities of acting on the autonomic tonus and reduction of cardiovascular overload.~     Hemodynamic conditions can change during the physical requirement and offer a framework of~     increased cardiovascular risk, especially for elderly individuals. In this sense,~     preservation strategies of cardiovascular autonomic control and demand in this population in~     conditions of rest and/or exercise are required. The aim of this study was investigate the~     effect of the essential eucalyptus oil on cardiovascular responses and recovery during~     submaximal isometric resisted exercise series in the elderly. Twenty elderly male (69.1 ± 5.7~     years; 75.3 ± 12.3 kg; 168.0 ± 6.0 cm) participated in this study. Were excluded from the~     sample the volunteers who presented some serious illness known according to the criteria of~     risk stratification of the American College of Sports Medicine. In random order crusade, the~     volunteers were subjected to: 1) trial session through the essential eucalyptus oil and~     inhalation; 2) session control without inhalation of essential eucalyptus oil. After the~     sessions 1 and 2, the volunteers remained in recovery for a period of 60 minutes, in~     temperature-controlled environment and comfortably seated. After this period were performed 3~     sets of isometric resisted exercise on dominant upper limb in intensity of 30% of maximum~     voluntary contraction in 1 min each, with 1 min recovery interval. Measures of heart rate,~     blood pressure, rate product pressure and heart rate variability were held in the rest for 20~     min, in recovery during 60 min and during the 3 sets of isometric resisted exercise.~     Indicators of heart rate variability were analysed from the time and the frequency domain.~     ANOVA two-way for repeated measurements with Post Hoc of Tukey were employed (p<0.05).~   "
69597|NCT02655991|"~     This study will determine whether telephone support improves clinical outcomes of veterans~     who begin outpatient treatment for posttraumatic stress disorder. Participants will be~     randomly assigned to receive either usual care or usual care supplemented by biweekly~     monitoring and support by telephone during the first 3 months of treatment. Patients in both~     conditions will be compared on PTSD symptoms, engagement in treatment, violence and drinking~     at 4 months and 12 months after entering treatment.~   "
69598|NCT02655978|"~     The overall goal of this study is to employ diffusion-weighted imaging (DWI) and tractography~     to investigate differences in connectivity in the rostral dorsal cingulum bundle (CB) in~     patients with bipolar disorder type I (BDI) or bipolar type II (BDII) compared to matched~     controls, and to utilize this information to determine if high-frequency deep brain~     stimulation (DBS) of the rostral dorsal CB has realistic potential as a therapy for producing~     mood stabilization in patients with BDI or BDII.~   "
69599|NCT02655965|"~     The aims of this study is to compare the effectiveness of pecs block associated to a general~     anesthesia in terms of Piritramide consumption compared with a general anaesthesia alone and~     the chronic pain incidence in patients that undergoing either a lumpectomy or a mastectomy~     associated with axillary dissection This is a double-blind, placebo controlled study that~     will randomise breast cancer subjects in 1:1 ratio to receive a pecs block of Ropivacaine~     3.5 mg/ml and Clonidine 5 µg/ml (arm A) versus placebo (arm B).~   "
69600|NCT02655952|"~     The Wnt proteins belong to a family of proteins that have been demonstrated to play a role in~     the formation and dissemination of tumours. The present project focuses on the critical role~     of the Wnt-5a protein in the pathobiological processes that lead to metastatic cancer~     disease.~      WntResearch has identified a formylated 6 amino acid peptide fragment, named Foxy-5, which~     mimick the effects of Wnt-5a to impair migration of epithelial cancer cells and thereby~     acting anti-metastatic.~      The aim of the first clinical phase I study was to establish the recommended dose for a~     clinical phase II study and enable further development of Foxy-5 as a first in class~     anti-metastatic cancer drug. The study did not see any DLTs and therefore failed to reach~     maximum tolerated dose (MTD); no recommended phase II dose (RP2D) could therefore be~     established based on toxicity. The aim of this study is to continue to establish the safety~     profile of Foxy-5 in higher doses, and determine the RP2D for later stage development based~     on any observed DLT's/MTD and further analysis of the pharmacodynamic profile of Foxy-5 to~     determine the biological response dose (BRD).~   "
69601|NCT02655939|"~     Reflex plus™ is a unique blend of Collagen Hydrolysate with Rosehip extract. The blend~     contains individual ingredients which have been widely studied for its effectiveness in~     osteoarthritis(OA). Collagen hydrolysate is accumulated in the cartilage and helps to repair~     the OA, related cartilaginous changes. Rosehip works in the anti-inflammatory pathway thus~     reducing the pain and inflammation of the joint.~      The two open-label studies have showed the effectiveness of the investigational product on~     OA. The 2 studies did not show any specific safety concern to be considered. The study~     demonstrated the synergistic effect of CH and Rosehip extract from former in-vitro results in~     the formulation.~      The supplement has been manufactured in GMP certified manufacturing units in Germany and~     India under strict quality control check. Hence, quality of the supplement and batch to batch~     consistency is well assured.~   "
69602|NCT02655926|"~     The overarching aim is to compare the effects of ventral capsule/ventral striatum (VC/VS) and~     subthalamic nucleus (STN) deep brain stimulation (DBS) in the same participants.~     Investigators will test the hypothesis, grounded in cognitive neuroscience, that DBS at both~     sites is better than either site alone for treating the symptom dimensions of obsessive~     compulsive disorder (OCD). Specifically, Investigators will employ novel cognitive paradigms~     and neurophysiological measures of cortical synaptic function to test the hypothesis that~     VS/VC and STN DBS have different mechanisms of action and that alleviation of OCD symptoms is~     mediated by improvement in mood/anxiety with VS/VC DBS and by directly interrupting~     obsessions and compulsions with STN DBS. Investigators will additionally determine whether~     adjunctive cognitive behavioural therapy (CBT) enhances the response to DBS by providing the~     cognitive and behavioural skills to optimise symptom management and daily function.~   "
69603|NCT02655913|"~     This trial studies efficacy and safety of combination of vitamin C infusion with modulated~     electro-hyperthermia (mEHT) in treatment of non small cell lung cancer patients.Phase I of~     this clinical study is to find the tolerable dose and best schedule of the combination of~     vitamin C infusion and mEHT that can be given to patients with NSCLC. Phase II of this study~     is to learn if the combination of vitamin C infusion and mEHT can help to control NSCLC and~     improve quality of life.~   "
69604|NCT02655900|"~     Injury to the muscles of the back passage (anal canal) is a relatively common problem. This~     injury can result in problems with bowel control later in life and usually occurs during~     vaginal childbirth (commonly referred to as 3rd and 4th degree perineal tears). Currently~     women who have sustained injury to the muscles of the back passage undergo an ultrasound scan~     by inserting a probe 3 to 4 cms into the back passage. This helps to check if the muscle of~     the back passage has healed i.e is intact or has a defect. The investigators would like to~     establish whether a 3D ultrasound scan probe placed outside the vagina can identify the~     defects and hence avoid inserting the probe into the back passage. In addition to getting the~     above information using 3D ultrasound scan, the investigators would also like to identify~     injuries to the pelvic floor muscle (levator ani) in these patients. Which can be diagnosed~     using the 3D ultrasound probe placed outside the vagina (perineum). Women who sustain injury~     to this muscle are known to develop prolapse later on in life.~   "
69626|NCT02655601|"~     This is a Phase 1/2 study of newly diagnosed patients with high grade glioma (HGG) undergoing~     standard radiation therapy and temozolomide treatment. BMX-001 added to radiation therapy and~     temozolomide has the potential not only to benefit the survival of high grade glioma patients~     but also to protect against deterioration of cognition and impairment of quality of life. In~     Phase 1 safety and tolerability of BMX-001 will be assessed using a two-stage Continual~     Reassessment Method (CRM). BMX-001 will be given subcutaneously first with a loading dose~     zero to four days prior to the start of chemoradiation and followed by twice a week doses at~     one-half of the loading dose for the duration of radiation therapy plus two weeks. In Phase 2~     both safety and efficacy of BMX-001 will be evaluated. Impact on cognition will also be~     assessed. Twenty-four patients will be randomized to the treatment arm that will receive~     BMX-001 while undergoing chemoradiation and 24 patients randomized to receive chemoradiation~     alone. The investigators hypothesize that BMX-001 when added to standard radiation therapy~     and temozolomide will be safe at pharmacologically relevant doses in patients with newly~     diagnosed high grade glioma. The investigators also hypothesize that in Phase 2 of this~     study, the addition of BMX-001 will positively impact the overall survival and improve~     objective measures of cognition in newly diagnosed high grade glioma patients.~   "
69605|NCT02655874|"~     TROPICS1 is a randomized, observer-blind, active comparator-controlled, single-center, Phase~     IV trial in 200 participants aged ≥65 years. The control group will receive a standard dose~     licensed trivalent inactivated influenza vaccine at day 1, and an active-comparator~     (Tetanus-diphtheria-pertussis vaccine) at day 180. Participants in the experimental group~     will receive the same influenza vaccine at day 1 and day 180. Endpoints are immunological,~     and include measures of haemagglutination-inhibition (HI) titres, micro-neutralisation titres~     and cell-mediated immunity at 4 time points after the initial vaccination up to Day 360. The~     primary hypothesis is that participants receiving an influenza booster at day 180 will~     achieve superior influenza seroprotection (HI titre ≥1:40) at day 208, compared to controls.~      The World Health Organization (WHO) estimates the global annual burden from seasonal~     influenza as 1 billion infections, with 3-5 million severe cases and 300,000-500,000 deaths.~     The pattern and impact of these infections varies considerably with climate. In temperate~     countries, influenza epidemics characteristically occur during the cold winter months, while~     in sub-tropical countries, they coincide with the rainy seasons. Closer to the equator,~     influenza virus activity is more complex. In Singapore, biannual epidemics are usual, but~     with continuous transmission year-round. Bi-annual epidemics, tri-annual epidemics and year~     round virus activity have also been described in other tropical countries, from Indonesia and~     Malaysia to Peru and Mexico.~      There is no published data reporting year-round influenza vaccine effectiveness in the~     elderly from countries with continuous influenza virus activity. Despite numerous studies~     worldwide exploring the HI antibody response to influenza vaccination, the majority of these~     do not continue follow up beyond seroconversion (21-28 days). However, of the few available,~     HI antibody titres declined following influenza vaccination in the elderly, such that within~     6-12 months geometric mean titres approached pre-vaccination levels. With biannual epidemics~     and year-round transmission in tropical regions, year-round seroprotection may be important~     to reduce influenza infections in this environment. A six-monthly vaccination cycle would~     correspond with the decline in vaccine-induced seroprotection in the elderly, and the~     6-monthly periodicity of outbreaks in Singapore and other tropical countries.~   "
69606|NCT02655861|"~     This project will follow babies with ichthyosis over time in order to better understand the~     natural course of ichthyosis in infants and children and to examine how specific genetic~     mutations affect clinical characteristics.~   "
69607|NCT02655848|"~     During arthroscopic rotator cuff (infraspinatus/supraspinatus) repair, biceps tendon lesions~     are frequently encountered. However, the most optimal treatment of the diseased long head of~     the biceps (LHB) tendon during rotator cuff repair remains a topic of debate: tenotomy or~     tenodesis. The hypothesis is that there is no difference in functional outcome between LHB~     tenotomy and LHB tenodesis when performed in adjunct to arthroscopic rotator cuff repair.~   "
69608|NCT02655835|"~     Phase 1 will follow 40 subjects and hopes to address whether or not IMMI can increase~     meditation practice as compared to another meditation program. The study will last six weeks~     for both the IMMI group (20 subjects) and the Access group (20 subjects). Access groups will~     receive learning materials and guided meditations, but the implementation will be self-paced.~     Participants in the IMMI group will receive weekly learning sessions and be required to~     practice meditation every day. IMMI group participants will also receive a weekly reminder~     call from a member of the study staff and have access to technical support in the event of~     trouble with the online program. All subjects will complete online self-report questionnaires~     that measure quality of life, self-efficacy, mood, sleep, mindfulness, and perceived stress~     at baseline and at the end of the six-week intervention. Subjects will also be given a~     questionnaire at the end of the study gauging their satisfaction with the mindfulness program~     they participated in.~      Phase 2 will follow 80 subjects and hopes to address whether or not IMMI is acceptable to~     participants and demographic information about IMMI users. The study will be the same as~     noted above, but all subjects will be entered in the IMMI program.~      Differences in recruitment rates, drop out, and patient satisfaction between the IMMI and~     Access groups will be analyzed. IMMI's ability to change meditation behavior (i.e. increasing~     time or frequency of meditation sessions), and improve quality of life will be examined as~     well.~   "
69609|NCT02655822|"~     This is a phase 1/1b open-label, multicenter, dose-selection study of CPI-444, an oral small~     molecule targeting the adenosine-A2A receptor on T-lymphocytes and other cells of the immune~     system. This trial will study the safety, tolerability, and anti-tumor activity of CPI-444 as~     a single agent and in combination with atezolizumab, a PD-L1 inhibitor against various solid~     tumors. CPI-444 blocks adenosine from binding to the A2A receptor. Adenosine suppresses the~     anti-tumor activity of T cells and other immune cells.~   "
69610|NCT02655809|"~     The aim of this study is to assess the in vivo kinematics and range of motion of a~     single-surgeon clinical series of TKA performed with a fixed-bearing cruciate retaining total~     knee arthroplasty that has a roll-back mechanism and compare it with the kinematic of the~     normal healthy knee.~      Patients would be evaluated by fluoroscopic examination during weight bearing activities~     (lounging, kneeling and stairs climbing).~   "
69611|NCT02655796|"~     This study evaluates the screening accuracy of a device (OAK) in assessing fall risk in the~     elderly, compared to the assessment provided by the Algorithm for Fall Risk Assessment of the~     Centers for Disease Control and Prevention (CDC).~      The OAK device is a technologic system, based on virtual reality. It allows to quickly~     perform a fall risk assessment integrating clinical indexes of the Brief-BESTest (The Balance~     Evaluation System Test), and kinematic and posturgraphic indexes. The participants interact~     with the OAK device through simple exercises, then the device provides an assessment of their~     functional mobility, equilibrium and postural reactions.~   "
69612|NCT02655783|"~     The objective of this study is to compare the effects of use of normal saline (250 cc / h),~     with or without dextrose supplement, on the evolution of labor in nulliparous.~   "
69613|NCT02655770|"~     The purpose of this study is to determine whether liraglutide a GLP-1 analogue are effective~     in the treatment of diastolic dysfunction in type 2 diabetes patients analyzed by cardiac~     MRI. Secondary if the treatment has any effect on the perfusion of the heart on a~     cardiac-MRI.~   "
69614|NCT02655757|"~     This study was to investigate the Effect of Sitagliptin, a dipeptidyl peptidase-4 inhibitor,~     on Progression of Coronary Intermediate Lesion.~   "
69627|NCT02655588|"~     The primary purpose of this study is to examine how much change in depressive symptoms will~     be observed in persons who use an electronic Problem Solving Treatment (imbPST) compared to a~     control group at pre-, mid-point, and post-test assessments.~   "
69628|NCT02655575|"~     Brief Summary:~      The purpose of the present study is to examine the effects of a Group based intervention~     consisting of vestibular rehabilitation (VR) combined with cognitive behavioral therapy (CBT)~     in patients with long--lasting vestibular dizziness. The study also aims to describe~     sociodemographic, physical and psychological characteristics in the patients, and to examine~     prognostic factors related to functional status and disability following participation in the~     intervention.~   "
69615|NCT02655744|"~     Background. Primary central nervous system lymphoma (PCNSL) is an uncommon disease.~     Conventional treatment has consisted of either whole brain radiotherapy (WBRT) or~     methotrexate (MTX)-based combined modality therapy combining chemotherapy and cranial~     irradiation. The treatment principles at our institute have been quite consistent in the~     past, sticking to the treatment protocol reported by Memorial Sloan-Kettering Cancer Center~     in 1990s. No matter what the dosage of MTX is, it is well-established that the addition of~     chemotherapy to cranial RT significantly improved survival outcomes. However, it was found~     that delayed treatment-related cognitive sequelae emerged as a significant debilitating~     complication of combined modality treatment in patients with PCNSL, especially when effective~     treatment can achieve disease control and better survival rates. Furthermore, the specific~     contribution of the disease per se and various treatment modalities to cognitive impairment~     remains to be clarified because the neurotoxic potential of combined modality treatments is~     difficult to differentiate when each can result in cognitive dysfunctions respectively.~      Treatment-related neurotoxicity could be demonstrated by virtue of several meaningful~     indicators, including neurobehavioral assessments, neuroimaging outcomes, and even measures~     of quality-of-life (QoL).~      Methods. Therefore, this one-year individual research will be a prospective observational~     cohort study with a longitudinal assessment of neurobehavioral functions, neuroimaging, and~     quality of life for newly-diagnosed patients with primary CNS lymphoma at our institute.~     According to our cancer center, it is estimated that there would be around 25 cases of~     newly-diagnosed primary CNS lymphoma at our institute every year. By virtue of~     multidisciplinary management and teamwork consisting of neurosurgery, hematology, radiation~     oncology, neuroimaging expertise, and surgical pathology, investigators will attempt to~     recruit all potentially eligible patients with newly-diagnosed primary CNS lymphoma. Most~     importantly, the neuropsychologists will participate in our research project, in an effort to~     integrate the neurobehavioral outcomes into this prospective study. Accordingly, a battery of~     neuropsychological measures is used to evaluate neurobehavioral functions for the studied~     patients. The battery is composed of ten standardized neuropsychological tests, covering four~     domains sensitive to disease and treatment effects (executive function, attention, verbal~     memory, psychomotor speed), and QoL questionnaires.~      Expected results. This prospective cohort study aims to explore and evaluate patients with~     PCNSL who are newly-diagnosed by using a standard battery of neurobehavioral functions plus~     neuroimaging studies. It is anticipated investigators will investigate and correlate~     neurotoxicity indicators in newly-diagnosed patients with PCNSL who are treated with cranial~     radiotherapy combined with or without MTX-based chemotherapy according to the~     multidisciplinary treatment guidelines implemented at a single institute.~   "
69616|NCT02655731|"~     Aim of the present prospective, single-centre study is to determine the outcome after pure~     PVI using HeartLight™ in 100 patients with different extents of LA-LVA.~      The latter will be assessed by an electro-anatomical voltage map using a commercial 3D~     mapping system (CARTO, Biosense Webster).~   "
69617|NCT02655718|"~     The purpose of the study is to assess short and long term outcomes of acute coronary syndrome~     in patients with non obstructive coronary atherosclerosis, to optimize the algorithm for~     diagnosis and to evaluate its effectiveness~   "
69618|NCT02655705|"~     This study evaluates the performance of objective psoriasis severity assessment tool compared~     with a subjective assessment tool for the assessment of the improvement of psoriasis after~     oral cyclosporine A or methotrexate treatment.~   "
69619|NCT02655692|"~     The purpose of this study is to test the safety and efficacy of repeated doses of ketamine as~     compared to placebo, in reducing symptoms of Posttraumatic Stress Disorder (PTSD) in an~     active duty military and Veteran population.~   "
69620|NCT02655679|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics,~     pharmacodynamics and preliminary clinical efficacy of VTP-38543 administered as a cream,~     twice-daily, for 28 days in otherwise healthy adult male and female patients with mild to~     moderate atopic dermatitis.~   "
69621|NCT02655666|"~     The purpose of the study is to observe/ collect clinical data, subject users' feedback, and~     device data to better understand the real-life usage and acceptance of the 722 Pump in type 1~     diabetes subjects,<18 years of age, and the role of insulin pump therapy in Qingdao,China.~   "
69622|NCT02655653|"~     The investigators primary objective is to compare the effectiveness of epsilon-aminocaproic~     acid (EACA) and tranexamic acid (TA) in reducing bleeding and transfusion in cardiac surgery,~     with the hypothesis that TA is more effective. The investigators also seek to further examine~     the clinical benefits and adverse effects profiles of epsilon-aminocaproic acid and~     tranexamic acid.~   "
69623|NCT02655640|"~     This research project has the overall objective to investigate the direction of the~     associations between illness perceptions, their influencing factors and health-related~     outcomes. Moreover, the investigators want to look at the direction of the associations~     between illness perceptions and health related outcomes such as psychological and physical~     functioning in patients with Systemic Lupus Erythematosus (SLE) and Systemic Sclerosis (SSc).~     The investigators want to know whether the outcome variables anxiety, depression, physical~     (dis) functioning are influenced by illness perceptions or vice versa. Not only the patients'~     illness perceptions but also the illness perceptions of the General Practitioners (GP) and~     rheumatologists will be investigated. The researchers want to know if the doctors'~     perceptions have an impact on the physical and psychological functioning of the patient or~     vice versa. Much research in the field of illness perceptions is cross-sectional in nature~     which means that the direction of the relationships between variables is not known.~   "
69624|NCT02655627|"~     Type 2 Diabetes Mellitus (DM) is a disease which is characterized with insulin resistance and~     exercise has positive effects on glycemic control and cardiovascular disease (CVD)~     development in these patients. Encouraging physical activity and exercise with using~     internet-based technology provides; potential to reach more people via comparatively low~     cost, 24 hour accessibility to services and for clinician, more frequent communication~     ability with the patient. In literature, there is no study examined exercise training via~     internet in patients with Type 2 DM. For this reason, considering the lack of the literature,~     the investigators aimed to compare the effects of internet based combined exercise training~     on glycemic control, functional capacity and physical activity level with supervised group~     training in patients with Type 2 DM. The purpose of the study is to provide convenience of~     rehabilitation access, glycemic control, offer an alternative physiotherapy and~     rehabilitation service which can help to improve physical activity level and obtain~     quantitative data for the applicability and contribution of internet based exercise training~     in patients with Type 2 DM.~   "
69625|NCT02655614|"~     This first-in-human, double-blind, placebo-controlled Phase I study will be conducted in~     participants with amyotrophic lateral sclerosis (ALS) to explore safety, tolerability, and~     pharmacokinetic (PK) properties of GDC-0134. It will include three components: a~     Single-Ascending-Dose (SAD) stage, a Multiple-Ascending-Dose (MAD) stage, and an Open-Label~     Safety Expansion (OSE) stage.~   "
69646|NCT02655341|"~     Aims:~        -  evaluate the hydric status through bioimpedance spectroscopy in consecutive acute~          myocardial infarction patients referred for primary PCI;~        -  assessment of renal artery stenosis incidence through renal angiography in consecutive~          STEMI patients;~        -  fully characterize the complex hydration, metabolic and endothelial profile of these~          patients in the attempt to define the role played by dehydration in the complex dynamics~          of acute myocardial infarction.~   "
69629|NCT02655562|"~     Cough is a common symptom that leads patients worldwide to seek medical attention. Subacute~     cough refers to a cough of 3-8-week duration, and is typically refractory to standard~     anti-tussive therapy, and a tendency to spontaneous healing was common. Few clinical trials~     have evaluated therapeutic options for subacute cough. Airway inflammation is an important~     feature of most of subacute cough, Cysteinyl leukotrienes and FeNO correlates with airway~     inflammation. Subacute cough often represents a prolonged post-viral response. Cysteinyl~     leukotrienes increase in virus infection. Airway inflammation induce epithelial cells produce~     iNOS(inducible nitric oxide synthase,iNOS), and FeNO increase in theory. Montelukast is a~     cysteinyl leukotriene type 1 receptor antagonist that is reported to improve cough16 and~     reduces FENO and prevents increases in FENO during reduction of inhaled corticosteroid dose,~     But A meta-analysis of the effectiveness of LTRA( leukotriene receptor antagonist,LTRA)in~     treating children with prolonged non-specific cough concluded that, with the lack of~     evidence, the routine use of LTRA in treating children with non-specific cough cannot be~     recommended. A randomised, placebo-controlled trial showed montelukast is not an effective~     treatment for postinfectious cough. Non-specialists or general practitioners of Japan~     prescribe LTRA very often, which increase. The aim is to research whether FeNO can be used as~     a biomarker to direct montelukast treatment and optimize treatment regimen of sub-acute~     cough.~   "
69630|NCT02655549|"~     The trial investigates Px563L and RPA563, two formulations of a novel anthrax vaccine.~   "
69631|NCT02655536|"~     This is an open-label, randomized, multicenter phase II study conducting in 3 medical centers~     in Asia. Patients will receive erlotinib in combination with bevacizumab or erlotinib alone.~     This study will enroll EGFR-mutant NSCLC patients who have asymptomatic brain metastases.~      The primary objective is to compare the systemic progression-free survival (PFS) to~     bevacizumab plus erlotinib versus erlotinib alone in patients with EGFR mutant NSCLC who have~     asymptomatic brain metastases.~   "
69632|NCT02655523|"~     Greater occipital nerve (GON) injection is a commonly performed diagnostic and therapeutic~     procedure in headache patients. GON blocks have been shown to be effective in the treatment~     of a variety of headaches including occipital neuralgia, migraine, vascular headache, cluster~     headache, cervicogenic headache, and post-concussive headache. Local anesthetic and steroids~     have been successfully used for diagnostic and or therapeutic nerve pain such as lumbar~     radicultis with great success. Dexamethasone is a water soluble steroid, when combined with~     local anesthetic; it may increase the analgesia of block duration relative to its~     pharmacokinetics. When compared to dexamethasone, triamcinolone, a particulate steroid has a~     slower onset time but may provide anti-inflammatory effects up to several weeks.~     Investigators want to investigate to see if there exists a difference in reported pain~     intensity using the particulate anti-inflammatory corticosteroid (triamcinolone with~     bupivacaine) which may provide a greater reduction in reported pain intensity relief may~     allow the patient to undergo fewer interventional procedures.~   "
69633|NCT02655510|"~     Alcoholic hepatitis is a syndrome of progressive inflammatory liver injury associated with~     long-term heavy intake of ethanol. The pathogenesis is not completely understood. Patients~     who are severely affected present with subacute onset of fever, hepatomegaly, leukocytosis,~     marked impairment of liver function (e.g., jaundice, coagulopathy), and manifestations of~     portal hypertension (e.g., ascites, hepatic encephalopathy, variceal hemorrhage). However,~     milder forms of alcoholic hepatitis often do not cause any symptoms.~      Alcoholic hepatitis usually persists and progresses to cirrhosis if heavy alcohol use~     continues. If alcohol use ceases, alcoholic hepatitis resolves slowly over weeks to months,~     sometimes without permanent sequelae but often with residual cirrhosis.~      F-652 is a recombinant fusion protein containing human interleukin 22 (IL-22) and human~     Immunoglobulin G2 (IgG2)-Fc produced in CHO cells in serum-free culture. F-652 under~     development is intended to treat patients with graft vs host disease (GvHD) after bone marrow~     transplantation, and acute alcoholic hepatitis (AAH), a severe form of alcoholic liver~     disease (ALD). Both GvHD and AAH are diseases with unmet medical need. The current~     investigational new drug (IND) application is to conduct a phase Ia clinical study in GvHD~     patients to evaluate the safety and pharmacokinetic profile, and biomarkers of F-652~     treatment by intravenous infusion (IV).~      IL-22 is a member of the IL-10 family of cytokines which control bacterial infection,~     homeostasis, and tissue repair. IL-22 may be used to treat patients with ALD because of its~     antioxidant, anti-apoptotic, anti-steatotic, anti-microbial, and proliferative effect that~     have been demonstrated in various experimental systems.~   "
69634|NCT02655497|"~     The purpose of this study is to determine the effectiveness of cognitive strategies in~     improving participation in daily activities within older adults who report subjective~     cognitive decline.~   "
69635|NCT02655484|"~     The purpose of this study was to evaluate whether CO2 rebreathing occurs in healthy subjects~     or patients with COPD ventilated during exercise assisted by the single-limb circuit with a~     plateau exhalation valve at a given inspiratory positive airway pressure and a minimal level~     of expiratory positive airway pressure (EPAP) and whether there is a potential threshold for~     predicting CO2 rebreathing.~   "
69636|NCT02655471|"~     This is a pilot study of intervention in a group of patients with tropical spastic~     paraparesis/ myelopathy to evaluate virologic and clinical response of raltegravir plus~     zidovudine in this group of patients.~   "
69647|NCT02655328|"~     This study will determine the pharmacokinetic profile of the salbutamol concentration in the~     urine while athletes are resting or during exercise.~   "
69648|NCT02655315|"~     This study evaluates the effect of iron chelation as a therapeutic strategy to slow the~     progression of Parkinson's disease. Half of participants will receive the deferiprone to 15~     mg / kg twice daily morning and evening (30mg / kg per day), while the other half will~     receive a placebo. The treatment lasts nine months.~   "
69649|NCT02655302|"~     Chronic obstructive pulmonary disease (COPD) is a worldwide chronic inflammatory disease of~     the airways linked to environmental exposure. The chronic course of COPD is often interrupted~     by acute exacerbations which have a major impact on the morbidity and mortality of COPD~     patients. A bacterial etiology for these exacerbations is common (almost 50%). Moreover,~     airway bacterial colonization linked to an increased susceptibility is observed in COPD~     patients. Effective Th17 immune response is needed to develop a good response against~     bacteria. Thus, this study aims to demonstrate that there is a defective IL-17/ IL-22~     response to bacteria in COPD leading to airway bacterial colonization and infection.~   "
69637|NCT02655458|"~     The purpose of this study is to explore the combination of Elotuzumab in combination with~     autologous stem cell transplantation and lenalidomide maintenance to see what side effects it~     may have and how well it works for the treatment of symptomatic multiple myeloma diagnosed~     and treated with induction therapy in the past year.~      Induction therapy is the first phase of treatment for multiple myeloma. The goal of induction~     therapy for multiple myeloma is to reduce the number of plasma cells in the bone marrow and~     the proteins that the plasma cells produce. Induction therapy is usually given for 3-4 weeks.~      An autologous peripheral blood stem cell transplant is a procedure in which immature stem~     cells are collected and stored for future use. A high dose of chemotherapy is given to the~     patient to destroy myeloma cells, and the patient's stem cells are replaced.~      The investigational drug in this program is elotuzumab. Elotuzumab is known as BMS-901608.~     Elotuzumab is a manufactured protein directed against a target found on multiple myeloma~     cells. Lenalidomide is currently approved for patients with multiple myeloma. Melphalan and~     cyclophosphamide, the drugs used during stem cell collection and transplant, are also~     approved by the U.S. FDA. Melphalan is an FDA-approved chemotherapy for multiple myeloma and~     is used as high-dose treatment prior to stem cell transplantation. Cyclophosphamide is an~     FDA-approved chemotherapy that may be used, either alone, or in combination with other drugs~     to treat multiple myeloma.~   "
69638|NCT02655445|"~     Setup of comparative trial The goal of this study is to determine whether one surgical~     treatment for chronic subdural hematoma is better than the other. Patients with a clear~     indication for drainage of subdural hematoma (as stated under Surgical options) will be~     randomized into three groups. One group will receive twist drill craniostomy followed by~     drainage during 48 hours. One group will undergo burr hole drainage (single if possible,~     double if necessary) with irrigation and drainage during 48 hours postoperatively. One group~     will undergo a minicraniotomy with trephine or craniotome, with wide opening of all visible~     membranes, rigorous irrigation and placement of Jackson-Pratt drain, followed by closed~     system draining during 48 hours. Postoperative results and complications will be compared~     between the three groups.~   "
69639|NCT02655432|"~     Screening of haitian children between the ages of 3 and 6 years old for amblyogenic risk~     factors with the use of the Spot photoscreener. The photoscreener results will be compared to~     the complete ophthalmologic evaluation. Primarily, this will allow evaluation of the~     performance of the spot photoscreener in the haitian children population. Secondarily, this~     study will gather epidemiological information on vision problems in the haitian children~     population.~   "
69640|NCT02655419|"~     Determine the PK and safety and tolerability of aztreonam-avibactam (ATM-AVI) in the~     treatment of hospitalized adults with cIAI~   "
69641|NCT02655406|"~     This study will be looking at the effect of compression therapy in patients having endovenous~     treatment for varicose veins using foam sclerotherapy. Patients will be randomised to either~     the compression group (group A) or the no compression group (group B).~      The pain scores, compliance, quality of life scores, occlusion rate at 6 months as well as~     the cost effectiveness of each intervention will be assessed.~   "
69642|NCT02655393|"~     Part A:~      The study is a double-blind, randomized, single ascending doses, study in 24 healthy elderly~     male and female volunteers. Each subject will be randomized for two subsequent doses in three~     cohorts.~      Part B:~      The study is a double-blind, randomized, multiple ascending doses study in 36 healthy elderly~     male and female volunteers. Subjects will be randomized to receive study product or placebo~     for 28 days.~   "
69643|NCT02655380|"~     Ketamine and opioid are known to improve the intubating condition, respectively. Combination~     of ketamine and opioid potentiate analgesic effect and give hemodynamic stability in~     complementary manner. Therefore, the combination use of ketamine and remifentanil could be~     useful for acceptable intubating condition in the general anesthesia without the use of~     neuromuscular blocking agent. Generally, induction dose of ketamine ranges between 1 and 2~     mg. There was no report about the optimal dose of remifentanil with 1 or 2 mg ketamine~     induction dose for intubation without neuromuscular blocking agent. The investigators focus~     on remifentanil dose using Dixon's up and down method.~   "
69644|NCT02655367|"~     This crossover study is designed to compare the gastric layering and rates of emptying and by~     inference rates of digestion of two different porridge meals prepared from either finely~     milled or flaked oats. On each of two study days, a total of 9 MRI scans will be taken, I~     baseline and 8 post meal, to assess gastric layering and emptying over three hours. Blood~     samples will also be taken periodically over the same period in order to determine changes in~     concentrations of circulating glucose, insulin and key gastrointestinal hormones.~     Participants will also be asked to complete a questionnaire at predetermined times to assess~     feelings of satiation.~   "
69645|NCT02655354|"~     The overarching goal of this UH2-UH3 proposal is to work with the NIH Health Care Systems~     Research Collaboratory to develop and implement a large scale, cluster randomized pragmatic~     clinical trial demonstration project that directly informs national trauma care system policy~     targeting injured patients with presentations of Posttraumatic Stress Disorder (PTSD) and~     related comorbidity. Each year in the United States (US), over 30 million individuals present~     to trauma centers, emergency departments, and other acute care medical settings for the~     treatment of physical injuries. Multiple chronic conditions including enduring PTSD, alcohol~     and drug use problems, depression and associated suicidal ideation, pain and somatic symptom~     amplification, and chronic medical conditions (e.g., hypertension, coronary artery disease,~     diabetes, and pulmonary diseases) are endemic among physical trauma survivors with and~     without traumatic brain injuries (TBI). Evidence-based, collaborative care/care management~     treatment models for PTSD and related comorbidities exist. These care management models have~     the potential to be flexibly implemented in order to prevent the development of chronic PTSD~     and depressive symptoms, alcohol use problems, and enduring physical disability in survivors~     of both TBI and non-TBI injuries; care management models may also be effective in mitigating~     the impact of the acute injury event on symptom exacerbations in the large subpopulation of~     injury survivors who already carry a substantial pre-injury burden of multiple chronic~     medical conditions.~   "
69748|NCT02654015|"~     The primary objective of this multicenter single arm feasibility study is to provide an~     assessment of enrollment and follow up feasibility for this patient population being treated~     with the Apollo Minimally Invasive Surgical Treatment (MIES). Patients who do not qualify for~     the INVEST Feasibility Study will be referred to the INVEST Registry study.~   "
69650|NCT02655289|"~     Pain is the most common symptom (ca. 80% of patients) on German Palliative Care units and~     thus, pain control plays a central role in palliative care.~      Transcutaneous electrical nerve stimulation (TENS) is a complementary treatment option for~     patients who experience suboptimal pain control. However, the evidence for the efficacy of~     TENS in cancer patients is not unambiguous.~      The present study is a double blind, placebo-controlled cross-over trial with a short-term~     follow-up.~      The primary aim of this study is to evaluate the efficacy and safety of TENS for cancer pain~     reduction in advanced cancer patients.~      The secondary aim is the explorative identification of subgroups that benefit or do not~     benefit from TENS.~   "
69651|NCT02655276|"~     This study is designed to investigate effects on attentional performance and motoric activity~     of 100 mg microencapsulated glycine (Bidicin® from Biotiki®) compared to placebo after~     treatment with t.i.d. sublingual doses over 3 weeks each.~      The primary objective of the study is to determine the effects on attentional performance and~     motoric activity of 100 mg microencapsulated Glycine (Bidicin® from Biotiki® ) compared to~     placebo after treatment with t.i.d. sublingual doses over 3 weeks each in children with low~     attentional performance and high motoric activity.~      A number of 30 prepuberal boys and girls aged 6 - 14 years with low attentional performance~     and high motoric activity will be enrolled in this study. The prepuberal status will be~     determined by Tanner stages ≤ 3.~   "
69652|NCT02655263|"~     Background: Humans naturally produce ketone bodies under daily living conditions. The main~     ketone bodies are two functioning acids, beta-hydroxybutyric acid (3-OHB) and acetoacetate,~     and the pH-neutral, but odorous, acetone. In the fed state, level of 3-OHB is suppressed to~     an almost unmeasurable level while, in the fasted state, it rises to 0.1-0.5 millimoles (mM).~     Main regulation of ketone synthesis is the abundance of sugars and resulting adaptations in~     insulin secretion. Thus, ketone bodies are formed when sugar is not readily available and~     insulin is suppressed. This picture is, to a certain degree, seen in acute inflammatory~     states and, indeed, during starvation, where level of 3-OHB increases to 5-8 mM.~      Hypothesis:~        1. Ketone bodies changes the insulin sensitivity and substrate metabolism in human subjects~        2. Ketone bodies changes the GH signaling in muscle and adipose tissue~      Aim: The investigators wish to provide knowledge on changes in metabolites and shift in~     signaling pathways and insulin sensitivity during GH infusion and concomitant ketone bodies~     infusion among healthy subjects.~   "
69653|NCT02655250|"~     This is a validation study to compare proposed field collection methods with a gold standard~     collection technique for microbiome analysis of stool and breast milk samples.~   "
69654|NCT02655237|"~     The purpose of this study is to evaluate the efficacy of TAK-385 40 mg administered orally~     once daily for 12 weeks, compared with leuprorelin injection (once/4 weeks, 1.88 mg or 3.75~     mg SC/time) in participants with uterine fibroids.~   "
69655|NCT02655224|"~     The purpose of this study is to evaluate the efficacy of TAK-385 40 mg administered orally~     once daily for 12 weeks, compared with placebo in participants having pain symptoms~     associated with uterine fibroids.~   "
69656|NCT02655211|"~     This study will evaluate the efficacy of pulsed dye laser (PDL) and carbon dioxide (CO2)~     laser in conjunction with usual care (MED) for the treatment of hypertrophic burn scars and~     will determine the optimal sequence and timing of lasers and usual care.~   "
69657|NCT02655198|"~     In this trial, the potential anti-epileptic effect of low dose fenfluramine in Lennox Gastaut~     epilepsy will be studied. An exploratory dose finding add-on trial is proposed. At baseline~     and at the end of the study, ECG and ultrasound of the heart will be performed as part of the~     safety follow up.~   "
69658|NCT02655185|"~     The purpose of this study is to determine whether lipid levels are related with incidence of~     atrial fibrillation in Patients with chronic heart failure.~   "
69659|NCT02655172|"~     Brief Summary: In schizophrenia, dislocation of psychic functions involving a loss of contact~     with reality is frequently found. A fragmentation of motor and sensory perceptions could be~     held responsible. However, automatic integration between perception and action is the~     necessary condition to be in relationship with the world. Affordance is the experimental~     link between object perception and potentially associated actions (Gibson, 1977, 1979)~     explored by Stimulus Response Compatibility (SRC) paradigm. With Tucker & Ellis sensory motor~     compatibility task (1998), with a modified response device (responses given with grasp), we~     study the impact of motor activation on these affordance effects. In this study, a group of~     controls will also be included in order to understand, as precisely as possible, the~     mechanisms involved (i.e., interference between the perception of the object and the response~     gesture).~   "
69660|NCT02655159|"~     This is a national, multicenter, retrospective, observational post-authorization study~     (EPA-OD) study. The study will be conducted by reviewing the medical records of patients up~     to the start of the study. In each case, only data from before the start of the study will be~     obtained in order to ensure they are retrospective in nature, thus reflecting the regular use~     of nab-paclitaxel in clinical practice and avoiding interference with the physician's~     clinical practice.~      To ensure the observational nature of this study, these data will be collected whenever they~     are available in the patient's medical record, and so no diagnostic or therapeutic~     intervention outside regular clinical practice will be used.~   "
69661|NCT02655146|"~     The aim of the present prospective randomized controlled study was to determine the effects~     of GnRHa add up to routine luteal phase support on frozen embryo implantation in frozen~     embryo transfer (FET).~   "
69673|NCT02654990|"~     The purpose of this study is to investigate the safety and efficacy of three different~     regimens of PAN (20 mg TIW, 20 mg BIW, and 10 mg TIW) in combination with s.c. BTZ and Dex~     and to provide exposure, safety and efficacy data to identify the optimal regimen of PAN in a~     randomized, 3-arm parallel design. This study will also assess the impact of administering~     s.c. BTZ (in combination with PAN and Dex) twice weekly for 4 cycles, and then weekly~     starting from Cycle 5 until disease progression in patients ≤ 75 years of age. Patients > 75~     years of age will receive for the entire treatment period s.c. BTZ weekly (in combination~     with PAN and Dex) until disease progression.~      Patients will be treated until disease progression or until they discontinue earlier due to~     unacceptable toxicity or for other reasons.~      Patients who discontinued study treatment for reasons other than disease progression will be~     followed for efficacy every 6 weeks.~      All patients will be followed for survival until the last patient entering long-term~     follow-up has completed a 3 year survival follow-up or discontinued earlier.~   "
69662|NCT02655133|"~     IgM-enriched immunoglobulins (IgGAM; Pentaglobin ® ) are new therapy for sepsis and septic~     shock since they support immune system especially in case of  immunoparalysis . However~     IgGAM isn't commonly prescribed, few centres use it as routine in severe infections and there~     aren't any guidelines to determine how and when to use them.~      Microcirculatory dysfunction is a crucial aspect in the pathogenesis of sepsis-induced organ~     dysfunction, resulting in hypoperfusion and tissue hypoxia. Unpublished clinical data suggest~     a beneficial effect of IgGAM at microvascular level proved with near infrared spectroscopy~     and Vascular occlusion test (VOT).~      This study is a double blind phase II prospective randomised controlled trial that will~     include patients admitted to the Intensive Care Unit of the University Hospital Ospedali~     Riuniti of Ancona, after no more than 24 hours from development of severe sepsis or septic~     shoc.~      Patients will be randomized into two groups (treaties and controls): patients in group of the~     treaties will be submitted to infusion of IgGAM conjugate (Pentaglobin ®) at dosage of 250~     mg/kg IV (5 mL/kg) per day (rate of 0.4 mL/kg/h), for 72 hours. The controls will receive~     equal amount of physiological NaCl solution (0.9%) as placebo. Neither the patient nor the~     staff nurses and MD will be aware of the group and of the treatment applied. IgGAM solutions~     or NaCl 0.9% will be provided by the hospital pharmacy in similar bags. The remaining~     treatments will not be changed in any way and will be at the discretion of the doctor who's~     in charge of the patient. All patients of the two groups will receive the optimal therapy for~     their conditions, according to good medical clinical practice (GMP), with appropriate~     antibiotic therapy, vasoactive and infusional therapy~   "
69663|NCT02655120|"~     The main objective of the study is to evaluate the effectiveness of the injection of bone~     marrow unconcentrated more R BMP 7 to repair necrosis of the femoral head with stage I-III~     classification FICAT.~   "
69664|NCT02655107|"~     Non-invasive measurement of hemoglobin in infants and neonates scheduled for elective~     congenital heart surgery, weighing between 3kg and 20 kg. SpHb measurement will be compared~     to the gold standard of hemoglobin measurement - CO-oximetrie - and to the point-of-care (GEM~     3500 premiere).~   "
69665|NCT02655094|"~     Unilateral pulmonary edema after minimal-invasive mitral valve surgery is a rare but in some~     cases severe complications, sometimes causing extracorporeal life support. The investigators~     have observed over several years 5 cases of instantaneous postoperative severe pulmonary~     edema. This is a retrospective analysis of over 200 minimal-invasive mitral valve surgery~     procedure.~   "
69666|NCT02655081|"~     To provide patients with bladder cancer who are scheduled to undergo radical cystectomy with~     a preoperative high-arginine nutritional supplement. The investigator will measure patient~     adherence to the regimen, tolerability of the supplement and feasibility of supplementation.~     Secondary outcome measures will include differences in length of stay and complication rate~     between groups.~   "
69667|NCT02655068|"~     The null hypothesis is that patients screened by PET/CT will not have detection of disease~     recurrence any earlier than those screened by CT alone. The alternative hypothesis is that~     PET/CT surveillance will lead to detection of disease recurrence 3 months earlier than CT~     surveillance. Furthermore, to reject the null hypothesis, earlier detection must be~     associated with a cause-specific survival improvement of 10%. Primary endpoints will include~     time from the completion of definitive therapy to diagnosis of recurrent disease, and~     absolute survival within 3 years after completion of initial therapy. Duration of survival~     between diagnosis of recurrence and subsequent death will not be a primary endpoint because~     the investigators expect that PET/CT will offer an opportunity for earlier recognition of~     recurrence and be subject to lead-time bias. Duration of survival will be measured from~     completion of primary treatment until death. Note: the presence of residual disease at~     surgical consolidation does not constitute a recurrence event.~   "
69668|NCT02655055|"~     A longitudinal, randomized, controlled, single-center Phase IV clinical trial will be~     performed to assess changes in bone mineral density (BMD) among voluntary apheresis blood~     donors. The primary outcome measure will be clinically significant decline in BMD at the~     lumbar spine assessed by dual-energy x-ray absorptiometry (DXA).~   "
69669|NCT02655042|"~     The primary purpose of this study is to assess the long-term safety profile of RCT-01~     injections as compared to placebo injections. This study will also measure the long-term~     impact these injections will have on tendon structure and function and the symptoms of~     Achilles tendinosis.~      This is study is designed to follow participants who have completed participation in a~     clinical trial where they received injections of either RCT-01 or placebo in the Achilles~     tendon. No clinical interventions will be performed as part of study procedures.~      The day of study entry (Visit 1) will be coordinated with the participant's final visit in~     the earlier clinical trial. All participants will return to the clinic for repeat assessments~     of their Achilles tendinosis and overall health 6, 12 and 18 months after study entry.~     Furthermore, they will complete 'telephone visits'; during which they will report information~     on their overall health; 3, 9, and 15 months after study entry. Total duration of patient~     participation is approximately 18 months.~   "
69670|NCT02655029|"~     The main objective of this study is to record, in routine clinical practice, patients'~     adherence to treatment with Perindopril/Indapamide/Amlodipine fixed dose combination, during~     4 months treatment.~   "
69671|NCT02655016|"~     This study is a double-blind, randomized, placebo-controlled (2:1 niraparib:placebo) study in~     patients with Stage III or IV ovarian cancer. Patients must have completed front-line~     platinum based regimen with a physician-assessed response of Complete Response (CR) or~     Partial Response (PR). Additionally, patients must have a normal or >90% decrease in cancer~     antigen 125 (CA-125) following front-line platinum treatment. The study will assess the~     efficacy of niraparib as maintenance treatment, as measured by PFS.~   "
69672|NCT02655003|"~     Almost all people who suffer from dementia experience neuropsychiatric symptoms (NPS) in the~     course of the disease. TIME (Targeted Interdisciplinary Model for Evaluation and treatment of~     neuropsychiatric symptoms) is a multicomponent intervention based on the theoretical~     framework of cognitive behavioral therapy (CBT). The TIME trial is designed to assess the~     effects of TIME on NPS in nursing homes patients with dementia and the implementation process~     at staff and organization level.~   "
69779|NCT02653599|"~     This trial is a multi-center, randomized, double-blind, placebo-controlled parallel group,~     Phase 2 study in subjects with Type 2 diabetes mellitus on a stable dose of metformin to~     evaluate the safety and efficacy of TTP273 versus placebo glucose control and body weight~     following administration for 3 months.~   "
69674|NCT02654977|"~     The study investigators' aim is to determine the long term safety and efficacy of Metreleptin~     (Myalept,) in promoting amelioration of metabolic abnormalities in patients with all forms of~     partial lipodystrophy. Patients will be offered this protocol under the following condition:~     Subjects have completed University of Michigan research protocol MB002-014 and have shown~     improved clinical benefit as judged by clinical criteria set forth in this protocol.~   "
69675|NCT02654964|"~     A study to determine the safety of CSC/ HTS-based combination drug therapy in subjects who~     have GBM that has recurred or progressed following prior radiation therapy and TMZ.~   "
69676|NCT02654951|"~     The project targets stroke survivors to investigate the effect of augmented feedback (using~     robotic force cues and visual feedback) on their upper limb reaching patterns and trunk~     compensatory movements.~   "
69677|NCT02654938|"~     Phase I single-blinded, randomized, placebo-controlled trial evaluating safety, tolerability,~     pharmacokinetics and pharmacodynamics of single injections of ascending doses of~     investigational drug product Mobilan (М-VM3) administered directly into the prostate of~     patients with prostate cancer.~   "
69678|NCT02654925|"~     In order to design new programs to help prevent weight gain, promote successful and~     sustainable weight loss, and help treat diseases related to obesity, the investigators need a~     better understanding of why accumulating fat in certain regions of the body is bad for~     health. It is known that not all fat cells are the same, but it was recently discovered that~     some fat cells may arise from stem cells that come from the bone marrow (bone marrow~     progenitors), a previously unrecognized origin. This discovery has been paradigm shifting,~     because dogma has long held that all white fat cells arise from fat tissue resident~     mesenchymal stem cells. This is also important because fat cells arising from the bone marrow~     lineage may be linked to worse health outcomes. The aim of this study is to determine if~     cells that were not previously believed to contribute to fat generation in humans are indeed~     capable of becoming fat cells. To answer this question the investigators will take samples of~     cells from the blood and the fat tissue of younger and older men and women, isolate the cells~     that came from the bone marrow and grow them in culture to determine if they will turn into~     fat cells. The results of this investigation may reveal potential mechanistic targets for~     future therapies to reduce the negative health outcomes associated with obesity related~     chronic diseases.~   "
69679|NCT02654912|"~     This study is designed to compare the effectiveness of reactive focal drug administration~     (RFDA) using dihydroartemisinin+piperaquine (DHAP) versus reactive focal test and treat~     (RFTAT) using artemether+lumefantrine (AL) as a routine process for identifying and~     eliminating malaria transmission as measured through achieving zero seropositivity in~     children under five in Southern Province, Zambia. These two strategies are potential~     candidates for expanded malaria operational surveillance and elimination for low malaria~     transmission areas.~   "
69680|NCT02654899|"~     The current study is the first clinical trial proposed with PF-06815345. It is designed to~     evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of~     single oral doses of PF-06815345 to healthy adult subjects.~   "
69681|NCT02654886|"~     The purpose of this research study is to determine if exercise will help improve muscle~     strength, endurance, and quality of life in individuals with Pompe disease. This is a~     research study to further define the outcome of patients with Pompe disease treated with a~     combined diet and exercise therapy.~   "
69682|NCT02654873|"~     Cholecystectomy has been made with benign conditions usually. The aim of this study is to~     compare the macroscopic evaluations of the cholecystectomy specimens with it's~     histopathological examinations.~   "
69683|NCT02654860|"~     This is a prospective, single centre, two-part, three doses study. Part 1 is a Phase I, three~     cohorts, dose-ascending, open-label, safety study. Part 2 is a Phase II, randomised,~     parallel-group, double-blind, placebo-controlled, exploratory efficacy and safety study The~     objective of the study is to investigate the efficacy and safety of a single intrathecal~     injection of paracetamol, administered at 3 doses to 3 active treatment groups, as compared~     to placebo solution, for post-operative analgesia of hip replacement surgery performed under~     spinal anaesthesia. Patients scheduled for hip replacement surgery will be randomised into 4~     treatment groups (15 patients per group) to receive either one of the 3 single doses of~     paracetamol 3% (D1: 60 mg, D2: 90 mg, D3: 120 mg) or placebo solution (P: saline solution) by~     intrathecal (IT) injection. Immediately after paracetamol or placebo IT administration, all~     patients will receive a single IT dose of Hyperbaric Bupivacaine HCl 0.5% (12.5 mg for ≤ 160~     cm-tall patients and 15 mg for > 160 cm-tall patients). The time interval between paracetamol~     IT and bupivacaine IT administrations should not exceed 2 min.~      The study will include a screening phase (Visit 1, Days -21/1), a treatment phase~     (paracetamol IT administration, anaesthesia and surgical procedure: Visit 2, Day 1) and a~     follow-up phase including an observation period (Visit 3, from Day 1 after surgery until~     discharge, a final visit (at discharge) and a follow-up (day 6±1). Pain at rest will be~     assessed at screening and on visit 2 at baseline (0 h), 1, 2, 3, 6, 9, 12, 15, 18, 21, 24,~     27, 30, 33, 36, 39, 42, 45 and 48 h after anaesthetic IT injection and at discharge, using a~     0-100 mm VAS.~   "
69684|NCT02654847|"~     Spinal anesthesia is the most common anesthetic technique for elective Cesarean delivery~     (CD), but the most frequent unwanted side effect is hypotension, which can cause nausea and~     vomiting, as well as effects on the fetus. Prevention and treatment of maternal hypotension~     includes intravenous fluids and vasopressors. Phenylephrine is the most common vasopressor~     used for this purpose. However, it has been shown to reduce maternal heart rate and cardiac~     output, which may be a concern in an already compromised fetus. Norepinephrine is commonly~     used in high concentrations in intensive care and recent studies have suggested that in low~     concentrations it may be a better alternative to phenylephrine in elective CD, as it does not~     reduce the maternal heart rate or cardiac output. The optimum bolus dose of norepinephrine to~     prevent hypotension after spinal anesthesia in elective CD has not been elucidated. The~     investigators propose this study to determine the dose that would be effective in 90% of~     patients (ED90).~      A previous study by Ngan Kee et al, using continuous infusion of norepinephrine to prevent~     hypotension in elective CD, suggested a potency ratio for norepinephrine to phenylephrine of~     approximately 16:1. Hence, the investigators hypothesise that the ED90 will be approximately~     6 µg, given that the current phenylephrine bolus dose at the investigators' institution is~     approximately 100 µg.~   "
69685|NCT02654834|"~     The purpose of this study is investigate to the effect(s) of chronic occupational exposure to~     N20 and volatile anesthetics on the extent of oxidative stress (DNA damage and the generation~     of the biochemical markers) in operating room staff, with different levels of exposure to~     halogenated hydrocarbons, in comparison to unexposed controls (Intensive Care Staff), and to~     determine the relationship between the degree of oxidative stress and psychological stress,~     as assessed by validated psychometric measures.~   "
69686|NCT02654821|"~     Patients with stage IV melanoma (also eye melanoma) will be treated with TCR transduced~     cells.~   "
69687|NCT02654808|"~     The purpose of this study is to compare CO2 absorption during gynecologic laparoscopy using~     the AirSeal® valveless trocar system versus standard insufflation trocars at intra-abdominal~     pressures of 10 and 15 mmHg.~      The investigators hypothesize that with the AirSeal® valveless trocar system, gynecologic~     laparoscopy can be performed at a lower intra-abdominal pressure with a possible resultant~     decrease in CO2 absorption, while maintaining adequate visualization of the operative field~     for safe completion of surgery.~   "
69688|NCT02654795|"~     Stroke remains the most dangerous and frightening complication of atrial fibrillation (AF).~     Numerous factors predisposing to peripheral embolism in patients with AF have been well~     defined, documented and included in the CHA2DS2VASC score. Although proper anticoagulation~     minimizes the risk attributable to known risk factors, stroke may still occur. Thus,~     unknown risk factors may play an important role in stroke risk stratification in patients~     with AF. The investigators assume that one of the important unknown risk factor is left~     atrial appendage (LAA) morphology. The ASSAM study is planned to include 100 patients after~     ischemic stroke or transient ischemic attack (TIA) and known status of anticoagulation at the~     time of stroke. The control group will consist of 100 patients scheduled for AF ablation~     without a history of stroke or TIA.~   "
69689|NCT02654782|"~     Looking at individual total fluid volume and alveolar-arterial gradient with 5% human albumin~     and Lactated Ringer's in the perioperative cardiac surgical patient.~      Our hypothesis is that the individual total fluid volume and alveolar-arterial gradient will~     be less with 5% human albumin compared to Lactated Ringer's in the perioperative cardiac~     surgical patient.~   "
69690|NCT02654769|"~     The objective of this study was to evaluate the safety and therapeutic equivalence of generic~     ingenol mebutate gel, 0.05% to Picato gel, 0.05% and to establish the superiority of the~     efficacy of these two products over the vehicle gel in the treatment of Actinic Keratosis~     (AK) on the trunk or extremities.~   "
69691|NCT02654756|"~     While there are proven therapies that slow CKD progression, these therapies can at times be~     harmful and costly. The ability to accurately predict the risk of CKD progression to ESRD~     would be extremely valuable. The short term versus lifetime risk of CKD progression should be~     taken into account when making risk based clinical decisions. In a representative CKD~     practice, the investigators compared the short term and lifetime risk assessment in our stage~     3 CKD patients to determine whether decisions based on a short term risk assessment would~     underestimate the lifetime risk of CKD progression. The investigators also applied the short~     term risk assessment to our stage 4 CKD patients to determine the frequency with which ESRD~     risk may be overestimated in CKD stage 4.~   "
69692|NCT02654743|"~     This is an open-label, 4-month study examining the effects of Sulforaphane (SF) on behavior~     in children with ASD and the correlation between behavior change and urinary metabolites. The~     goal is to determine a potential mechanism of action of SF in this population.~   "
69693|NCT02654730|"~     The purpose of this study is to evaluate the tolerability and safety of increasing doses of~     primaquine in combination with dihydroartemisinin-piperaquine in G6PD deficient males.~   "
69694|NCT02654717|"~     The purpose of this study is to see how well DFD-07 works in treating actinic keratosis on~     the face and scalp during 8 weeks of treatment. The study will also look at any unwanted~     effects of the study drug.~   "
69695|NCT02654704|"~     To follow longitudinally healthy and immune-compromised responses to pneumococcal~     vaccination, in 60+ individuals towards the development of personalized medicine~     implementation (minimum enrollments in 2 age categories: young adults[18-25], older adults~     [55+], within each category: 10+ healthy, 10+ asthma, 10+ immune-compromised [e.g. leukemia~     or autoimmune disorders]). The approach will profile thousands of molecular components~     utilizing high-throughput technologies and integrate these data to obtain personalized immune~     response to vaccination. The study will provide insights into immune response mechanisms~     specific to asthmatics, immune compromised and healthy individuals, as well as in response to~     vaccination. Additionally the differences in dynamic response across the two age groups will~     be investigated.~   "
69696|NCT02654691|"~     This is a clinical study which is a follow-up of a previous prospective questionnaire study.~     All patients who previously participated in the study will receive a new questionnaire and~     will be invited for a clinical examination.~   "
69697|NCT02654678|"~     Paediatric long-term safety follow-up clinical trial in maximum 100 children with heart~     failure due to dilated cardiomyopathy or congenital heart disease, from 1 day to less than 12~     years of age at recruitment into the preceding short-term pharmacokinetic~     (PK)/pharmacodynamic (PD) trials. Pharmacodynamic measurements and renal monitoring in all~     children after 1 , 4, 7 and 10 months of follow-up; in addition PK assessments as well as~     acceptability and palatability assessments in children still under enalapril Orodispersible~     Minitablet (ODMT) treatment.~   "
69721|NCT02654366|"~     Efforts to help syringe exchange registrants employ additional HIV risk reduction strategies~     are often thwarted by strong social networks that reinforce substance use and other risky~     injection use and sexual behaviors. The proposed study addresses this important problem by~     evaluating the feasibility and efficacy of a novel Community Supported Risk Reduction group.~     This structured intervention works with injection drug users and at least one drug-free~     family or friend to mobilize social support, teach HIV risk reduction skills, develop~     treatment readiness, and support participation in community activities designed to expand~     drug-free social networks.~   "
69722|NCT02654353|"~     This is a prospective randomized controlled trial that compares the conventional stepwise~     approach with a new sequential substrate ablation approach for persistent atrial~     fibrillation.~   "
72300|NCT02620592|"~     This First in Human (FIH) Phase I study intends to evaluate the safety, tolerability,~     pharmacokinetics and pharmacodynamics of ZYDPLA1 in normal healthy adult volunteers.~   "
69698|NCT02654665|"~     Non-alcoholic fatty liver disease (NAFLD) is defined by presence of hepatic steatosis (fat~     accumulation in liver cells), either by imaging or by biopsy and absence of causes for~     secondary hepatic fat accumulation such as significant alcohol consumption, medications, or~     hereditary disorders. In the majority of patients, NAFLD is associated with risk factors for~     cardiovascular disease such as obesity, diabetes mellitus, and high cholesterol, and may lead~     to irreversible liver damage. Non-alcoholic steatohepatitis (NASH) is a more severe form of~     NAFLD and is present in up to 30% of obese adults. NASH is defined by hepatic steatosis and~     inflammation with hepatocyte injury with or without fibrosis (hardening of the liver).~      The prevalence, morbidity and mortality of NAFLD is increasing, particularly in the~     Asia-Pacific region where there will be an estimated 300 million obese people by 2030. Weight~     loss is the first-line treatment for NAFLD in obese individuals, but the utility of lifestyle~     modification with diet and exercise is limited by difficulties in sustaining compliance and~     by eventual weight regain. Bariatric (weight loss) surgery produces the greatest amount of~     weight loss but is limited by cost, patient acceptance, and complications. The efficacy of~     drugs for NASH, such as vitamin E and medication to lower cholesterol and glucose, remains~     unclear. Liraglutide, a glucagon-like peptide (GLP-1) analogue, is an injectable medication~     which has been shown to induce weight loss and lower glucose in obese adults. There is little~     information on the effects of GLP-1 analogues on NASH, particularly in comparison to other~     modalities of weight loss such as surgery. This study aims to compare the efficacy and safety~     of lifestyle modification, liraglutide and surgery, for weight loss in conjunction with~     reducing severity of NASH, and for insulin resistance, high cholesterol and other~     cardiovascular risk factors.~   "
69699|NCT02654652|"~     The purpose of this study is to determine whether the symbiotic use in patients with head and~     neck cancer impact on intestinal function after surgical treatment.~   "
69700|NCT02654639|"~     Phase II study of TAS-102 plus bevacizumab switch maintenance therapy in patients with mCRC~   "
69701|NCT02654626|"~     This is a randomized, single-blind, placebo-controlled, sequential parallel-group and~     multiple ascending dose (MAD) study to evaluate the safety, tolerability and pharmacokinetics~     of KBP 7072 in healthy subjects. The safety will be assessed at each dose level before~     progressing to the next higher dose.~   "
69702|NCT02654613|"~     This study addresses the highest ranking health research priority in South Africa, which is,~     to develop and test optimal models of HIV-TB service delivery that will enhance retention,~     adherence and coverage of HIV-TB co-infected patients. HIV and TB are highest in sub-Saharan~     Africa, a region with limited health budgets, infrastructure, human resources, and suboptimal~     TB infection control practices. There is compelling clinical evidence suggesting that~     integrating HIV and TB services saves lives and presents an effective and efficient use of~     resources directed at optimizing health outcomes. Quality improvement (QI) methods are~     increasingly being used to systematically test and incorporate local ideas into strategies~     for reliable implementation and scale up. This trial is designed to test a practical,~     implementable and affordable strategy aimed at improving HIV-TB service integration to reduce~     TB and HIV associated deaths. This is a cluster randomized controlled trial, which evaluates~     and tests the effectiveness of implementing a QI model to integrate HIV-TB service delivery~     in primary health care clinics, on reducing morbidity and mortality in TB-HIV co-infected~     patients. This study will be conducted in 2 districts, Ugu and uThungulu, in KwaZulu-Natal,~     South Africa. The model of integrated care delivery for TB and HIV using the QI method offers~     a systems approach to care delivery to directly enhance treatment outcomes by enabling~     comprehensive effective care designed around the patients journey from entry to the clinic,~     through screening treatment initiation, treatment completion, and retention in care that is~     directed at the goals of cure for TB, effective sustainable HIV viral suppression and reduced~     HIV associated TB mortality as the main health impact. The scalability of the model, once~     proven effective, is the critical element that makes it increase population coverage of~     quality diagnosis and treatment of HIV-TB co-infection. QI methods promote front line staff~     engagement in identification and rapid testing of local implementation solutions to gaps in~     performance of processes of care along the steps of the patient journey. Gaps in care are~     identified through continuous feedback on a core set of indicators collected monthly as~     routine collection of data.~   "
69703|NCT02654600|"~     the decrease in thoracopulmonary compliance after cardiac surgery is well known . The~     investigators hypothesize that the major factor determining pulmonary outcome after cardiac~     surgery is the alteration of pulmonary compliance during cardiopulmonary bypass(CBP) and that~     this alteration is due to CBP itself through pulmonary blood emptying.~   "
69704|NCT02654587|"~     The aim of this study is to determine if the Investigational Medicinal Product Tedopi~     (OSE2101) is more effective than standard treatment in treating patients with stage IIIB~     NSCLC unsuitable for radiotherapy or metastatic NSCLC in second- or third-line treatment.~   "
69705|NCT02654574|"~     In France, about 1 million people 65 and older are diagnosed with dementia syndrome~     characterized by cognitive decline and impairment of functional capacity. The assessment of~     the level of functional autonomy is therefore an essential step in monitoring patients in~     Memory Clinic and can be estimated by the Lawton IADL questionnaire, assessing the patients'~     ability to perform daily tasks.~      In the Memory Clinic, the first estimate of the level of patient autonomy is achieved during~     a face-to-face interview between their primary caregiver and a nurse, using the IADL~     questionnaire. This assessment should be renewed every year. The IADL questionnaire is part~     of the information that the memories consultations shall transmit to the Alzheimer's National~     Bank (BNA).~      However, current practice has shown that the systematic collection is problematic in the~     organization of Memory Clinic. It is thus expected to collect this questionnaire by phone in~     order to measure changes in the level of autonomy during the disease, and improve the~     completeness of this collection. A study is conducted with the main objective to measure the~     reliability of the assessment of IADL questionnaires conducted during a telephone interview~     with the caregiver of the patient, in comparison to the reference mode: the face-to-face~     interview with the caregiver.~      Materials and methods The experimental design of the study will be a randomized crossover~     trial (crossover), including 394 patients divided into two branches. In the first part, the~     collection of the IADL questionnaire will be performed according to the reference method in~     the consultation (face-to-face interview with the nurse), the measurement will be repeated at~     1 month intervals by phone. In the second part the sequence of execution modes will be~     reversed. The reliability of the measurement of the level of autonomy will be studied by~     comparing repeated measurements based on handover modes. The correspondence between the~     repeated measures will also be considered in terms of patient characteristics. The~     feasibility of administration of the questionnaire by phone mode will be evaluated.~      Expected results The mode of administration by phone should allow to obtain a reliable~     measurement of the level of patient autonomy when the administration is carried out in a~     standardized way. The study should also identify patients and situations for which this~     method of administration by phone may be appropriate.~   "
69706|NCT02654561|"~     The primary objective of this study is to estimate the efficacy of unfractionated~     heparin(UFH) on ICU mortality in severe sepsis with suspected DIC.The Second objective is to~     estimate the effect of UFH on 28-day mortality,and the change of the Japanese Association for~     Acute Medicine(JAAM) score and SOFA score. The third one is to evaluate the safety of UFH in~     severe sepsis patients with suspected DIC.~   "
69707|NCT02654548|"~     To investigate whether women with polycystic ovary syndrome who are post-partum excrete~     higher levels of sebum in comparison to healthy controls due to high levels of androgens.~   "
69723|NCT02654340|"~     Association of specific mutations (genotype) after sequencing the TSC1 and TSC2 gene with the~     clinical manifestations (phenotype) of the tuberous sclerosis complex in a cohort of~     clinically well characterized tuberous sclerosis complex patients. The obtained samples will~     be used to establish a tandem-MS-based biomarker.~   "
69724|NCT02654327|"~     This is a trial of a new way of treating patients with respiratory failure. The investigators~     propose to deliver a multi-centre clinical trial to determine whether veno-venous~     extracorporeal carbon dioxide removal (VV-ECCO2R) and lower tidal volume mechanical~     ventilation improves outcomes and is cost-effective, in comparison with standard care in~     patients who are mechanically ventilated for acute hypoxaemic respiratory failure~   "
69725|NCT02654314|"~     A double blind randomized controlled trial investigating melatonin, 5mg, compared to placebo,~     given to patients at least 65 years old, admitted to the hospital on a general medical floor,~     to prevent delirium.~   "
69708|NCT02654535|"~     Peanuts and tree nuts (almonds, pistachios, walnuts, pecans, pine nuts, Brazil nuts, cashews,~     hazelnuts, macadamia nuts) (herein referred to as nuts) are a good source of unsaturated~     fatty acids, vegetable protein, fibre, and polyphenolics. Nut intake has been associated with~     reduced cardiovascular disease risk and claims for this association have been permitted by~     the FDA; however, intake of tree nuts is low in Canada. One of the barriers to increasing the~     consumption of nuts is the perception that they may contribute to weight gain more than other~     healthy foods owing to their high energy density. The evidence supporting this concern,~     however, is lacking. In a series of earlier systematic reviews and meta-analyses, we have~     shown that nuts improve glycemic control and metabolic syndrome criteria, findings which run~     contrary to any expected weight gain. However, it remains unclear whether nuts have an~     increasing, neutral, or even decreasing effect on body weight. To address the uncertainties,~     the investigators propose to conduct a series of systematic reviews and meta-analyses of the~     totality of the evidence from controlled trials and prospective cohort studies to investigate~     the effect of nut consumption on body weight and adiposity. The findings generated by this~     proposed knowledge synthesis will help improve the health of consumers through informing~     evidence-based guidelines and improving health outcomes by educating healthcare providers and~     patients, stimulating industry innovation, and guiding future research design~   "
69709|NCT02654522|"~     The purpose of this study is to determine whether or not Recombinant DNA-based hyaluronidase~     (RDNAH/Hylenex recombinant), is safe and effective for dissolving hyaluronic acid (HA) dermal~     fillers.~   "
69710|NCT02654509|"~     This study is being conducted to collect safety and immunogenicity data for the EEE vaccine.~   "
69711|NCT02654496|"~     The purpose of this study is to investigate mechanisms responsible for weight change in~     patients who have undergone weight loss surgery. Specifically, we will compare the gut~     microbiota, plasma bile acids, plasma gut peptides (GLP-1, GLP-2, and PYY), and plasma LPS in~     three groups of subjects: 3-5 years post gastric bypass patients who experienced sub-optimal~     weight loss, 3-5 years post gastric bypass patients who had successful weight loss, and a~     control group who has not had a weight loss surgery and are of similar age, gender, body mass~     index as the gastric bypass groups.~   "
69712|NCT02654483|"~     Our goal is to determine whether daily oral administration of VPD-737 (5 mg) is effective and~     safe in adolescents and adults with Epidermolysis Bullosa (EB).~   "
69713|NCT02654470|"~     The WATCHMAN™ Left Atrial Appendage Closure (LAAC) Technology is intended to prevent thrombus~     embolization from the left atrial appendage and reduce the risk of life-threatening bleeding~     events in patients with non-valvular atrial fibrillation who are eligible for anticoagulation~     therapy or who have a contraindication to anticoagulation therapy.~   "
69714|NCT02654457|"~     The purpose of the study is the identification and semi-quantification of Ki-67 protein~     expression level in breast cancer tissues by the GenASIs GoPth system as compared to manual~     reading of the same slides.~      The imaging system is intended for diagnostic use as an aid to the pathologist in the~     detection, counting and classifying ER/PR IHC stained samples~   "
69715|NCT02654444|"~     The purpose of the study is the identification and quantification of protein expression level~     in breast cancer tissues.~      The imaging system is intended for diagnostic use as an aid to the pathologist in the~     detection, counting and classifying her2 immunohistochemical (IHC) stained samples.~   "
69716|NCT02654431|"~     The purpose of the study is the identification and quantification of proteins expression~     level in breast cancer tissues.~      The imaging system is intended for diagnostic use as an aid to the pathologist in the~     detection, counting and classifying ER/PR IHC stained samples.~   "
69717|NCT02654418|"~     SIC 8000 is indicated for use in gastrointestinal endoscopic procedures for submucosal lift~     of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions, prior to~     excision with a snare.~   "
69718|NCT02654405|"~     The purpose of this grant is to evaluate the efficacy of sodium butyrate as a novel treatment~     for cognitive deficits in schizophrenia (SZ).~      The proposal consists of a small preliminary open label study to assess tolerability and side~     effects of sodium butyrate in schizophrenic patients receiving antipsychotic treatment,~     followed by a larger double-blind study of the effects of sodium butyrate on cognitive~     function and symptoms in SZ patients who are not in an acute exacerbation of the primary~     symptoms and show continued cognitive deficits. Secondary aims will be to evaluate its~     effects on improving symptoms and functioning in SZ, and the relationship of the drug's~     clinical effects to epigenetic and inflammation related biochemical changes.~   "
69719|NCT02654392|"~     Many studies in the past three decades have examined the beneficial effects of omega-3~     polyunsaturated fatty acids in diet and supplementation. The effect of polyunsaturated fatty~     acids, specifically omega-3 and omega-6, on health have been well-studied but most of the~     study to date has been on animal not plant sources and much less is know about their effects~     on exercise performance. Additionally, while positive effects have been detected for~     sedentary populations or those that are at risk, well-trained athletes generally have not had~     established advantages in taking supplements for omega-3 and omega-6 oils. There is evidence~     that a specific ratio of omega-6 to omega-3 is most beneficial for the human body with~     regards to cardiovascular and mental health. In this study, participants randomized to either~     a plant supplement group (pureform omega; containing Flax, Evening Primrose, Sunflower,~     Coconut & Pumpkin oils; Natural Product Number = 80050660) or placebo (isoenergetic sugar~     pills) will be subjected to both a time trial and a high intensity interval bout, where their~     performance and power output will be analyzed. Blood lactate and glucose concentration, as~     well as oxygen consumption and carbon dioxide production will also be examined to determine~     if there is a change in on fat oxidation after supplementation.~   "
69720|NCT02654379|"~     This study is to characterize the indications for which rituximab is being used and to~     evaluate the use of the Patient Alert Card (PAC) in participants receiving the medication for~     non-oncology conditions at infusion centers. The study involves the retrospective chart~     review of rituximab users' medical records in non-oncology indications as well as a survey to~     collect information on participant characteristics, and will include questions about~     participant knowledge on the risk of infections, participant receipt and review of the PAC,~     and any actions the participant has taken as a result of receiving the PAC.~   "
69727|NCT02654288|"~     Investigators have previously found that the infiltration of immunoglobulin G4(IgG4) positive~     plasma cells in tumor tissue predicts a poor prognosis of pancreatic cancer after curative~     resection. Investigators further attempt to explore the possible roles of IgG4 and the~     inducer of IgG4, interleukin-10(IL-10), in the chemotherapy of pancreatic cancer. In this~     primary study, investigators plan to observe the dynamic changes of sera IgG4 and IL-10 in~     peripheral blood after gemcitabine-based chemotherapy and analyze the correlations of IgG4~     and IL-10 with the response of gemcitabine and overall survival of pancreatic cancer.~   "
69728|NCT02654275|"~     Many children and adolescents who engage in swimming complain of shoulder pain during or~     after exercise. This pain may worsen and may lead to a decline in performance as well~     avoidance of swimming and lastly avoidance of any physical activity whatsoever. The aim of~     this study is to determine whether proprioceptive intervention training will effect the power~     capacity, proprioceptive ability and technique of young swimmers.~   "
69729|NCT02654262|"~     Obesity during adolescence, a critical time for bone development, may impair mineral accrual~     and reduce bone strength, leading to greater fracture risk during adolescence and later in~     life. This study seeks to determine the effect of obesity and accompanying metabolic changes~     (insulin resistance and inflammation) on bone mineral accrual and related changes in~     structure and strength in young girls. The information is critical to developing effective~     prevention strategies to counter the linked risks of obesity and osteoporosis, both major~     public health concerns.~   "
69730|NCT02654249|"~     The study evaluates postoperative pain, morbidity, recurrence and quality of life, comparing~     two different strategies in the treatment of grade III and IV hemorrhoids: transanal~     hemorrhoidal dearterialization with mucopexy (THD) versus hemorrhoidectomy by Ligasure™.~   "
69731|NCT02654236|"~     The main purpose of this study is to see whether heavy drinking will interfere with a~     specific pathway, called FXR signaling in the liver. The abnormality of this pathway may lead~     to liver injury in some patients who drink heavily.~   "
69732|NCT02654223|"~     The purpose of the study is to evaluate the more efficient dose for the treatment of~     rhinitis/rhinoconjunctivitis against grass pollen allergy~   "
69733|NCT02654210|"~     The purpose of this study is to determine in what way infections, microbiome, and~     vaccinations during childhood interact in shaping the development of immunity and tolerance.~     The investigators collect and use data from a birth cohort focusing on infectious diseases~     during childhood and apply a life course perspective.~   "
69734|NCT02654197|"~     The investigators believe that there is an association between H. pylori infection and~     nutritional status and between H. pylori infection and cognitive development. The current~     study will examine this association in Israeli children, aged 6-12 years.~   "
69735|NCT02654184|"~     The quality of induction with sevoflurane, along with its ability to generate optimal~     conditions for Laryngeal Mask Airway (LMA) insertion without supplemental opioids or muscle~     relaxants, has also been well documented. An ideal inhalation induction technique besides~     being rapid and comfortable for the patient should be economical. To achieve rapidity, use of~     vital capacity breaths with 8% sevoflurane is a more popular method of induction compared~     with the conventional incremental induction.~   "
69736|NCT02654171|"~     VICTOR is a randomized, double-blind, placebo-controlled, multicenter, 2-part study to~     evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antiviral effect~     of single and multiple dosing of AK0529 in infants hospitalized with RSV infection.~   "
69737|NCT02654158|"~     Phase IV trial,Single-arm, multi-centre clinical trial to assess the efficacy and safety of~     Fuganlin Oral Liquid in children with acute upper respiratory infection~   "
69738|NCT02654145|"~     Mepolizumab is an anti-interleukin-5 ( IL-5) monoclonal antibody that neutralizes IL-5 and~     reduces eosinophil counts in both sputum and blood. Omalizumab an anti-immunoglobulin E (IgE)~     monoclonal antibody (mAb) is effective in the treatment of moderate to severe allergic~     asthma. The aim of this study is to investigate whether subjects not optimally controlled on~     their current omalizumab treatment, who are eligible for therapy with mepolizumab can be~     effectively and safely switched to treatment with mepolizumab to improve asthma control. The~     study will provide data on the efficacy, safety, immunogenicity, and tolerability of~     mepolizumab when switched directly from omalizumab without any wash-out. The learnings from~     this study may help guide physicians when substituting one biologic with another for the~     treatment of patients with severe eosinophilic asthma.~      The study will be a multi-centre, open-label single arm trial. Patients with severe~     eosinophilic asthma who are receiving omalizumab, but are not optimally controlled will be~     eligible to participate. Subjects will remain on their current maintenance therapy including~     omalizumab throughout the run-in period for a minimum of one week and up to 4 weeks. At Visit~     2 (week 0) subjects will discontinue their omalizumab treatment and be switched to~     mepolizumab 100 mg subcutaneous (SC) every 4 weeks for 28 weeks. The treatment period is 32~     weeks, including an Exit Visit/Early Withdrawal Visit, 4 weeks following the subject's last~     dose of mepolizumab.~   "
69739|NCT02654132|"~     The purpose of this study is to determine if adding Elotuzumab to Pomalidomide and low-dose~     dexamethasone is a more effective treatment of relapsed and refractory multiple myeloma~     compared to pomalidomide and low-dose dexamethasone by itself.~   "
69740|NCT02654119|"~     This phase II trial studies the side effects and how well cyclophosphamide, paclitaxel, and~     trastuzumab work when given after surgery in treating patients with stage I-II human~     epidermal growth factor receptor (HER2/neu) positive breast cancer (confined to the breast or~     the breast and lymph nodes under the arm). Drugs used in chemotherapy, such as~     cyclophosphamide and paclitaxel, work in different ways to stop the growth of tumor cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Monoclonal antibodies, such as trastuzumab, may interfere with the ability of~     tumor cells to grow and spread. Giving cyclophosphamide, paclitaxel and trastuzumab after~     surgery may help prevent the cancer from coming back.~   "
69741|NCT02654106|"~     This clinical trial was designed to investigate the efficiency and toxicity of fractionated~     stereotactic radiotherapy(FSRT) combined with Temozolomide(TMZ) for refractory brain~     metastases.~   "
69742|NCT02654093|"~     The purpose of this study is to learn about the effect of raloxifene on how the body absorbs~     and processes cholecalciferol and how cholecalciferol affects raloxifene when they are taken~     together.~   "
69749|NCT02654002|"~     This study will evaluate the safety and tolerability of escalating single- and multiple-oral~     doses of GS-9674, and characterize the single- and multiple-dose pharmacokinetics (PK) of~     GS-9674. The study will be conducted in 3 parts (Part A, Part B, and Part C). Participants~     will receive either GS-9674 or GS-9674 placebo.~      Part A will proceed in 4 prespecified staggered cohorts. Within each cohort, the cumulative,~     blinded safety data will be evaluated for dose escalation from single-dose (Period 1) to~     multiple-dose (Period 2). Based on the available safety, pharmacokinetics, and/or~     pharmacodynamics (PD) data from cohorts in Part A and Part C (if applicable), total daily~     doses and frequency of dosing will be chosen for the cohorts in Part B. Parts B and C will~     consist of adaptive cohorts and may be initiated in parallel. Part B cohorts may be initiated~     in parallel with cohorts in Part A if the total dose under evaluation is at or below a dose~     already evaluated.~      This study is partially blinded (no one is blinded on Day -1).~   "
69750|NCT02653989|"~     The purpose of this study is to evaluate the efficacy and safety of MDV9300 in patients with~     relapsed or refractory diffuse large B-cell lymphoma (DLBCL) that have achieved either stable~     disease or a partial remission following definitive salvage therapy.~      Two cohorts of patients will be enrolled: a cohort treated with salvage chemotherapy but~     considered ineligible for autologous stem cell transplant (ASCT), and a cohort of patients~     who have received ASCT following salvage chemotherapy.~   "
69751|NCT02653976|"~     This study is a phase 2 multinational, multicenter, single-arm, open-label, non-randomized~     study to evaluate the efficacy and safety of SP-02L monotherapy in relapsed or refractory~     patients with peripheral T-cell lymphoma.~   "
69752|NCT02653963|"~     This triple-blind, stratified, randomized clinical trial includes 100 eyes of 100 patients~     aged 18 to 85 years with refractory glaucoma. Eligible subjects undergo stratified block~     randomization; eyes are first stratified to one of four subgroups: group 1:patients with~     previous failed trabeculectomy, group 2: uveitic glaucoma, group 3: neovascular glaucoma and~     group 4: other indications like aphakic glaucoma or glaucoma associated with vitreoretinal~     procedures.~      In each subgroup, eyes are randomly assigned to the study arms using random blocks:~     conventional Ahmed Glaucoma Valve (AGV) implantation (group A, 50 eyes), Ahmed Glaucoma Valve~     (AGV) with intraoperative periplate triamcinolone injection (group B, 50 eyes).~      Patients will be followed for one year. They will undergo full ophthalmology examination at~     first day, first week, month 1, 3, 6, 9 and 12 after the surgery.~      The primary outcome measure is cumulative probability of success, defined as intraocular~     pressure (IOP) of 6-21 mm Hg, with or without medication, and no serious complications,~     additional glaucoma surgery, or loss of light perception.~      The outcomes will be compared between two arms in each subgroup.~      The number of eyes requiring medications, time to initiation of medications, and number of~     medications will be compared.~   "
69753|NCT02653950|"~     In this study the investigators aim to assess whether endoscopic septoplasty is effective at~     improving patients QOL and reducing postoperative signs and complications.~      Primary outcome: To assess the differences in overall QOL between endoscopic and traditional~     septoplasty after adjusting for pertinent confounding variables.~      Secondary outcomes:~        1. To evaluate the post-operative complication rate in patients undergoing endoscopic~          septoplasty compared to traditional.~        2. To evaluate the differences in the operation time between the two different approaches.~   "
69754|NCT02653937|"~     Abstract~      Background & Aims:~      Abdominal N line tenderness for diagnosis and shigyakusan for treatment of irritable bowel~     syndrome ( IBS ) and medically unexplained physical symptoms ( MUPS ) were studied.~      K1 is point of one quarters of distance from center of navel to right anterior superior iliac~     spine. K2 is one quarters of distance from center of navel to upside of the symphysis pubis.~     K3 is center of line from xiphoid process to navel. There are three relevant lines; K1-K3~     line, K2-K3 line, and line of identical length to K1-K3 line originating from K2 and running~     parallel to K1-K3 line. Author collectively named these 'N line'. There was not the study~     under author's investigation that effects of shigyakusan and other medicines were compared.~     Author confirmed existence of mild IBS, for whose patients existing largely, various~     expensive examinations are spent.~      Method:~      The author put pressure on N line by deep palpitation and judged of abdominal N line~     tenderness positive or negative.~      Shigyakusan, a Kampo medicine, was administered to each of N line positive patients, of IBS~     by Rome III, of no IBS by Rome III, and of MUPS. The change of symptoms of IBS and MUPS by~     shigyakusan was showed with an arrow by self-declaration.~      Conclusions:~      Shigyakusan was more effective for IBS than previous medicines. IBS was diagnosed by Rome III~     and N line tenderness and author confirmed the existence of mild IBS which was diagnosed by N~     line tenderness with help of RomeIII. MUPS showed N line tenderness though patients~     complained of no abdominal symptoms. Shigyakusan was very effective for IBS, mild IBS and~     MUPS.~   "
69755|NCT02653924|"~     The final stage of any surgical procedure is suturing. Sutures have a vital rule in wound~     healing- they are responsible for flaps approximation, hemostasis and restoring function and~     esthetics.~      Choosing the right suture is crucial especially in oral sites because of its unique~     anatomical features: the presence of saliva and the patient's everyday function- swallowing,~     talking, eating etc.~      Sutures require certain physical properties such as tensile strength, dimensional stability,~     lack of memory, knot security and elasticity. One highly important quality is the ability to~     prevent or reduce bacterial adhesion and by that to prevent secondary infection. There are~     many kinds of sutures in the market- none of which contains all the ideal features.~      The aim of the study is to compare the amount of bacterial adhesion to different kinds of~     sutures in patients undergoing periodontal surgery.~   "
69756|NCT02653911|"~     Polycystic ovary syndrome (PCOS) is a dysfunction of endocrine system of women of~     reproductive age. Approximately 5%-10% women in China have this syndrome. Irregular~     menstruation (oligomenorrhea or amenorrhea), hirsutism and obesity are the common clinical~     manifestations of PCOS. The aim of this study is to evaluate the efficacy of acupuncture in~     improving the menstrual frequency of PCOS patients who do not have fertility requirements.~   "
69776|NCT02653638|"~     Cerebral vasodilator responses to CO2 will be measured in young healthy adults, healthy~     sedentary older adults, and healthy exercise trained older adults. This variable will be~     examined before and after administering the cyclooxygenase inhibitor indomethacin, which has~     been shown to blunt cerebral vasodilator responses. In addition, the investigators will~     examine these counter-regulatory hemodynamic mechanisms to hypoperfusion caused by~     indomethacin.~   "
69757|NCT02653898|"~     Antimalarial drug resistance has reached critical levels on the Thai-Cambodian border. Many~     have begun advocating for concerted malaria elimination efforts in Cambodia. However, there~     is currently no consensus on how malaria elimination is to be achieved with the tools~     available.~      In this study, the investigators will conduct operational research with the Royal Cambodian~     Armed Forces (RCAF) and National Malaria Center (CNM) to quantify the relative effectiveness~     of the two major interventional approaches - monthly malaria prophylaxis (MMP) or focused~     screening and treatment (FSAT) - in a head to-head comparison. In addition, the investigators~     will quantify the relative contribution of a recently advocated vector intervention for~     military personnel - the insecticide treated uniform (ITU) - in addition to other vector~     control measures currently employed by the RCAF. The investigators will employ the same~     permethrin insecticide self-application kits currently used by the US military. The~     investigators will estimate the cost effectiveness of each approach and attempt to define the~     best way forward for malaria elimination efforts in a critically important malaria reservoir~     in military population (and their dependents) who reside on the Thai-Cambodian border. The~     aim of the study is not only to conduct research to better define the best way forward in~     malaria elimination efforts in the high risk military populations, but to also build capacity~     within the RCAF to support and lead future elimination efforts in the most difficult-to-reach~     mobile populations.~   "
69758|NCT02653885|"~     The outcome predictors for cardiac surgery has been popular for many researchers and~     clinicians. Determining risk factors before surgery reduce morbidity and mortality after~     surgery. Some routine blood results have been used as predictors for cardiac surgery but none~     of the researches studied red cell distribution width, mean platelet volume,~     platelet/lymphocyte ratio and neutrophil/lymphocyte ratio. This study focused on these~     parameters and to see whether these parameters can be predictors for cardiac surgery.~   "
69759|NCT02653872|"~     This is a phase 1, non-randomized, fixed sequence, 3-period, drug-drug interaction study to~     assess the pharmacokinetics (PK) of AZD7986 in healthy subjects when administered alone and~     in combination with multiple doses of verapamil and itraconazole or diltiazem~   "
69760|NCT02653859|"~     By testing the CTC number of new solitary pulmonary nodule patient, evaluating the~     correlation of CTC number and benign and malignant lung nodules auxiliary diagnosis, the~     correlation of CTC number and the size of lung nodules of the malignant patients, the~     correlation between the CTC number and subtypes of malignant lung nodules patients.The CTC~     and tumor markers will be detected before the patient received treatment. Tumor markers~     include Pro-GRP, NSE, CEA, CYFRA211, SCC.~   "
69761|NCT02653846|"~     Portal hypertension (PH) results from the increase of portal flow resistance in fibrotic~     tissue of the liver in patients with chronic liver diseases, leading to complications such as~     varices formation and variceal bleeding, ascites formation, spleenomegaly and~     hypersplenismus, systemic haemodynamic disorders and porto-systemic shunts formation. Early~     detection of PH in patients with chronic liver diseases is clinically important as it should~     change patient management in order to prevent the formation/onset or recurrence of PH~     complications. Hepatic venous pressure gradient (HVPG) measurement is the gold standard for~     the assessment of the severity of PH. However, it is an invasive method with its risks, and~     relatively costly. On the other hand transient elastography (TE) emerged as a non-invasive,~     easy, safe and low cost method with the potential to assess the severity of PH, as liver~     stiffness (LS) and spleen stiffens (SS) measured by TE showed very good correlation with~     HVPG. Real-time 2D shear wave elastography (RT-2D-SWE) is an ultrasound elastography method~     reliable for non-invasive assessment of fibrosis stage especially in chronic viral hepatitis,~     but only preliminary data exist on the correlation of RT-2D-SWE measured LS/SS with and HVPG.~     In this study we hypothesized that LS and SS measured by RT-2D-SWE correlate with HVPG~     enabling RT-2D-SWE to be used for the assessment of severity of PH. The primary aim of this~     study is to analyse correlation between LS and SS as assessed by RT-2D-SWE and TE with the~     grade of portal hypertension as assessed by HVPG. The secondary aims are: 1) to analyse~     clinical outcomes of these patients in order to determine if LS and/or SS as assessed by~     RT-2D-SWE might predict adverse outcomes (liver decompensation, death or HCC development),~     and 2) to compare clinical performance (AUC) of RT-2D-SWE and TE for the assessment of the PH~     severity as well as for predicting clinical outcomes. Patients with suspicion of having~     compensated advanced chronic liver disease (cACLD) as assesed by non-invasive methods~     (transabdominal ultrasound, laboratory findings, FIB-4 and APRI score, and LS measurements by~     TE), will be included. Since positive predictive value of non-invasive methods for cirrhosis~     is generally not very reliable, these patients will be offered transjugular liver biopsy and~     HVPG measurements as gold-standard methods to define the stage of liver disease and severity~     of PH. These patients will undergo LS and SS measurements by RT-2D-SWE on Aixplorer~     SuperSonic Imagine ultrasound system and HVPG measurements as well, with transjugular liver~     biopsy performed during the same session. After SWE™ and HVPG measurement, 5-year follow-up~     is planned, including standard surveillance: laboratory findings, transabdominal US every six~     months and upper-GI endoscopy according to relevant guidelines, as well as treatment~     according to relevant guidelines as indicated: beta blockers, endoscopic variceal ligation,~     etiologic treatment and dietary measures. Appropriate statistical analysis will be undertaken~     after the enrollment period, as well as after follow-up period.~   "
69762|NCT02653833|"~     This pilot study tests the hypothesis that the medication nitric oxide extract from beetroot~     juice improves blood flow to the skeletal muscle during exercise. The investigators will use~     cutting edge technology with contrast enhanced ultrasound to visualize the microvascular~     blood supply to the forearm. Animal studies have shown reversal of muscle damage with~     improved delivery of blood to the exercising muscle. This research aims to understand the~     mechanism of action of this medication in a way it has never been studied before. The results~     may help benefit individuals with muscular Dystrophy in the future.~   "
69763|NCT02653820|"~     Reflexology treatment may influence the severity of chemotherapy-induced nausea and vomiting.~     This study aims to investigate the clinical effect of reflexology on chemotherapy-induced~     nausea and vomiting.~   "
69764|NCT02653807|"~     Ankle rigidity is a common musculoskeletal disorder affecting the talocrural joint, which can~     impair weight-bearing ankle dorsiflexion (WBADF). The objective was to compare the efficacy~     of Mulligan Mobilization with Movement (MWM) and Osteopathic Mobilization (OM) for improving~     ankle dorsiflexion range of motion (ROM) and musculoarticular stiffness (MAS).~   "
69765|NCT02653794|"~     It is reported that it takes a period form 22 weeks pregnant to the first 45 months of life~     for macular region to develop from structural formation to functional integrity. However,~     children are still in the critical period of plastic visual development, for their visual~     acuity has not yet reached the level of adults. Similarly macular retinal structure may~     develop with age. It is very important to study in macular thickness of this period and to~     have a proper cognition of it and the relation between macular thickness and other ocular~     parameter for the research of retinal development and diseases and the early screen of fundus~     diseases.~   "
69777|NCT02653625|"~     This is a single-arm, open label, proof of concept (PoC) study of Cenicriviroc (CVC) in adult~     subjects with Primary Sclerosing Cholangitis (PSC). The main objective of this PoC study is~     to assess changes in alkaline phosphatase (ALP) both individually and as a group, over 24~     weeks of treatment with CVC.~   "
69778|NCT02653612|"~     The goal is to improve surgery by preventing tumor cells from being left behind at the time~     of surgery. This includes finding residual tumor cells in the wound after surgery.~   "
69766|NCT02653781|"~     Realistic simulation is an effective teaching strategy for the acquisition and retention of~     knowledge and increased self-confidence of students, which contribute to safety in performing~     nursing actions.Considering the need to adopt safe practices in health since professional~     training, there are deficiencies in health teaching and weaknesses in the acquisition of~     practical skills guided by safety principles and critical clinical reasoning. The purpose is~     to compare the use of high fidelity simulation with traditional education as innovative~     method in the process of teaching and learning. This is a prospective, randomized, controlled~     and single-blind study, of pre-test and post-test experimental type, with application of high~     fidelity simulation in the theme of patient safety in administration of parenteral drugs.~   "
69767|NCT02653768|"~     Knee osteoarthritis (OA) is one of the most common chronic conditions and a leading cause of~     disability among Veterans. Although exercise is known to improve pain, physical abilities,~     and other outcomes for patients who have knee OA, most individuals with this condition are~     physically inactive. Therefore there is a need to develop programs that will help Veterans~     and others with knee OA to increase activity levels. This study will examine a stepped~     approach to helping Veterans with knee OA to increase physical activity, with increasing~     levels of program intensity when needed for individual patients to meaningfully improve pain~     and physical function.~   "
69768|NCT02653755|"~     This research study is a way of gaining new knowledge about whether patients can omit~     radiation treatment after undergoing a lumpectomy, also known as breast conserving surgery.~     In this trial, we are attempting to identify which patients may not need radiation.~   "
69769|NCT02653742|"~     The purpose of this study is to compare the efficacy and safety of ketorolac sublingual with~     fentanyl intranasal used in our hospital for pain control in children undergoing bilateral~     myringotomy with placement of pressure equalization tubes (BMTs).~   "
69770|NCT02653729|"~     This study aims to examine the effectiveness of cognitive behavior therapy for psychosis in~     first episode patients and see the outcome of CBT on psychotic symptoms. Because cognitive~     behavior therapy mostly use in depressive patient to treat the negative thinking pattern~     Cognitive behavioral approaches in the treatment of psychosis have become more prevalent in~     recent years for a number of reasons. Evidence has been available for the past two or three~     decades regarding the success of these techniques with other forms of psychopathology such as~     depression, anxiety disorders, and medical problems. Anxiety, depression and low self-esteem~     have been cited as the most common consequences of psychotic disorders. The observation has~     also emerged that many patients develop their own coping strategies for reducing the~     frequency, severity, and disruptiveness of their symptoms. There has also been increasing~     evidence regarding the influence of social environmental factors on the course of psychosis~     and the development of stress-vulnerability models to explain these relationships. Research~     suggests that 20 to 50 percent of persons with psychosis who receive neuroleptics continue to~     experience difficulties related to their psychotic symptoms.~   "
69771|NCT02653716|"~     To evaluate the clinical and cost-effectiveness of the New Orleans Intervention Method (NIM)~     in relation to an enhanced services as usual model, Case Management (CM), for the management~     of maltreated infants and young children entering care in the United Kingdom (UK) .~   "
69772|NCT02653703|"~     The aim of this study is to quantitatively characterize the effects of L-menthol as a topical~     counter-irritant on cutaneous pain and hyperalgesia provoked by topical application of the~     TRPA1-agonist trans-cinnamaldehyde (CA) in healthy human volunteers.~   "
69773|NCT02653677|"~     The purposes of the present study are to determine the glycemic and insulinemic responses,~     the satiety rate and the postprandial plasma concentrations of free fatty acids,~     triglycerides and satiety hormones after the ingestion of four types of breads: handcrafted~     bread made with wheat organic flour; handcrafted bread with wheat flour of large-scale retail~     distribution; handcrafted bread with organic einkorn flour and a commercial wheat bread.~   "
69774|NCT02653664|"~     Chronic pain is a significant problem for many Veterans, including new Veterans returning~     from Iraq and Afghanistan. It is also associated with a number of other significant problems,~     such as post-traumatic stress disorder and sleep problems. All of these can have significant~     negative effects of the quality of life of Veterans~      Three different types of treatment that have been used to treat chronic pain in the general~     population include self-hypnosis, education about chronic pain, and teaching individuals how~     to be more mindful. The purpose of this study is to see if these three treatments can help~     decrease pain in Veterans. Additionally, the researchers want to determine if each of these~     treatments can help reduce the negative consequences associated with pain, such as changes in~     mood, sleep, and enjoyment of life.~      Different types of treatment that include self-hypnosis, education about chronic pain, and~     learning skills on how to change how a person perceives his/her pain have been used to treat~     chronic pain the general population.~      The purpose of this study of this study is to see if these different treatments can help~     decrease pain and improve quality of life in Veterans with chronic pain, and determine how~     and why these treatments are effective. A subject must have a Veteran status, have chronic~     pain, speak English and be at least 18 years old to participate.~      Sleep Sub-Study~      Chronic pain and sleep problems are common among Veterans. Study researchers believe the~     treatment interventions provided as part of the main study will help improve pain and sleep.~     However, the main study does not include a real time measurement of sleep nor does it~     include any specific strategies for examining the relationship between sleep and pain.~      Previous research has shown that adequate sleep has been linked to improvements in pain~     reports. Adversely, sleep deprivation has been found to increase pain perception since it~     decreases a person's ability to disengage from pain. Therefore, the purpose of this sub-study~     is to measure sleep in order to learn more about how it interacts with chronic pain.~      All of the subjects in this sub-study will be Veterans recruited from VA Puget Sound who~     experience moderate-to-severe chronic pain on a regular basis and who have enrolled in the~     main study. Study investigators will enroll up to 135 subjects into the sub-study.~   "
69775|NCT02653651|"~     Open nephrectomy is one of the most common surgical procedures in urologic practice. Pain~     after surgery remains a significant clinical problem as it impairs recovery adversely and may~     lead to the transition to chronic pain. The open approach represents a major physical trauma~     including postoperative pain and discomfort in the convalescence period. Adequate control of~     postoperative pain facilitates earlier mobilization and rehabilitation. Patient-controlled~     analgesia (PCA) is effective to treat pain at rest, but seems to be inadequate for dynamic~     analgesia and may also elicit side effects that may delay hospital discharge. Preventing~     early and late postsurgical pain is an important challenge for anesthesiologists and~     surgeons.~      Ketamine (N-Methyl-D-Aspartate receptor antagonist) and lidocaine (sodium channel blocker)~     are popular analgesic adjuvants for improving perioperative pain management. The~     investigators designed this double-blind, placebo controlled study to test and compare the~     preventive effects of perioperative intravenous ketamine and lidocaine on early and chronic~     pain after elective open nephrectomy.~      The investigators propose a double-blind placebo-controlled study of patients undergoing~     elective open nephrectomy. All patients will receive normal patient-controlled analgesia~     morphine in addition to study drugs or placebo. Research will be conducted at Charles~     Nicolle teaching hospital.~   "
69780|NCT02653586|"~     The study was a group randomized controlled trial. Within each school Classes of high school~     students were allocated by randomization to the intervention or control group by a function~     Randomization in Excel program. Outcomes were measured by questionnaire at pre- intervention,~     post-intervention and 3-month follow-up. The study protocol was approved by Tel Hai college~     institutional review board. Parents of all participants, in the intervention and in the~     control group, received information about the program and the study and were choose whether~     to provided informed consent or not.~   "
69781|NCT02653573|"~     This study was designed to evaluate the feasibility of a telephone-based health coach~     self-management intervention for young adults.~   "
69782|NCT02653560|"~     In the DASH (Dietary Approaches to Stop Hypertension) trials, a diet rich in fruits,~     vegetables, nuts and dairy products, and limited in fat content, was shown to be useful in~     controlling hypertension. Key components of such a diet are potassium, magnesium and alkali,~     each of which has been implicated in lowering blood pressure. Whether a liquid formulation of~     potassium-magnesium citrate will result in equivalent BP effect as the DASH diet is unknown.~   "
69783|NCT02653547|"~     Patients receive two weeks of treatment (prefrontal high-frequency and bilateral~     low-frequency rTMS vs. prefrontal high-frequency and bilateral high-frequency rTMS). After~     two weeks of treatment they can decide if they want to quit the treatment or if they want to~     proceed with the treatment for another two weeks.~   "
69784|NCT02653534|"~     This study is being conducted to assess the impact of promoting community initiated Kangaroo~     Mother Care (KMC) for low birth weight babies on post enrolment neonatal mortality and~     mortality post enrolment upto 6 months of age. This large individually randomized controlled~     trial will enroll 10500 low birth weight babies. The secondary objectives are examining the~     impact of the intervention on exclusive breast feeding and growth at 1 and 3 months,~     infections and hospitalizations in the neonatal period and from 1 to 5 months of age,~     recognition of illnesses and early care seeking from appropriate sources, motor and mental~     development in a subsample.~      Newborns weighing >=1500 to <=2250gm are being enrolled into the study within 3 days of~     birth. Eligible babies are randomized to intervention or control arms. Mothers in the~     intervention arm are supported for KMC and breastfeeding by study ANM (Auxiliary Nurse~     Midwife) and study ASHA (Accredited Social Health Activist) like workers . Routine home~     visits are conducted in both intervention and control arms by government workers according to~     the existing government program.~      Survival will be ascertained in all enrolled infants through contacts at 1, 3 and 6 months.~   "
69785|NCT02653521|"~     The purpose of this study is to evaluate the benefit of adaptive radiation therapy (adaptive~     radiation therapy, ART) for esophageal cancer, using dose tracking technique with online~     images and deformable registration.~   "
69786|NCT02653508|"~     The Feeding-Exercise Trial in Adolescents (FETA) was a randomised controlled intervention~     study designed to promote healthy weight in overweigh and obese adolescents through a~     professional-delivered, community-based program with active parents' involvement, focused on~     supervised physical activity and structured nutritional education. The aim of FETA was to~     test the efficacy of two intervention groups- physical activity in isolation and combination~     of physical activity with provision of dietary information- for improving overweight and~     obesity in adolescents. Our primary hypothesis was that a combined program would be more~     efficacious than activity in isolation and that activity alone would also be effective~     compared to control group in improving adiposity profiles in overweight and obese adolescents~     as well as family activity and feeding habits.~   "
69787|NCT02653495|"~     Metabolic syndrome (MetS) is a cluster of metabolic conditions associated with obesity that~     predispose individuals to coronary heart diseases and diabetes but obesity has been shown to~     increase the risks of other diseases like cancer and asthma. Studies have also shown that~     obesity increases the risk of severe influenza infection and associated death and reduces the~     efficacy of influenza vaccine in the obese population but yet, the molecular mechanisms have~     not been described. The investigators are thus hypothesizing that differences in the innate~     immune responses between individual with or without metabolic syndrome impact viral infection~     and vaccine outcome. The investigators will perform seasonal influenza vaccination in people~     with or without metabolic syndrome to determine if the late adaptive response assessed by~     antibodies titers is different between the two groups and correlates with the early immune~     response assessed by gene expression profile in whole blood cells. The project proposed by~     the investigators will contribute to a better understanding of the inflammatory phenotype~     associated with metabolic syndrome and establish for the first time if it affects the immune~     protection against infectious diseases and particularly against influenza virus infection.~     The results will be important to determine if the population affected by metabolic syndrome~     should receive anti-influenza treatment in priority in the context of a severe influenza~     epidemic.~   "
69788|NCT02653482|"~     The primary purpose of this study is to evaluate the impact of dapagliflozin, as compared~     with placebo, on heart failure disease-specific biomarkers, symptoms, health status, and~     quality of life in patients with chronic heart failure with reduced systolic function.~   "
69789|NCT02653469|"~     Pulse pressure variation (PPV) is a well-known and widely used dynamic preload indicator~     based on heart-lung interaction to predict fluid responsiveness. Generally, patients are~     considered to be fluid-responsive when the PPV value larger than 11-13%. However, several~     previous researches demonstrated that there is a zone of uncertainty (grey zone) in PPV. To~     predict fluid-responsiveness accurately in the patients with PPV within grey zone (9-13%),~     the investigators would evaluate the augmented PPV using augmented ventilation.~   "
69790|NCT02653456|"~     The purpose of this study is to evaluate the safety and efficacy of an excimer laser in the~     treatment of patients with lower extremity vascular disease with chronic total occlusions.~   "
69791|NCT02653443|"~     The objective of this study is to test the hypothesis that INTERCEPT Blood System for~     platelet components stored for 6 or 7 days after INTERCEPT Blood System treatment retain~     sufficient viability for therapeutic efficacy. The post-infusion recovery and lifespan of~     autologous INTERCEPT Blood System for platelet components in 35% plasma/65% InterSol (Test~     platelets) stored for 6 or 7 days will be measured in comparison to fresh autologous~     radiolabeled platelets (Control platelets) according to FDA guidance for platelet testing~     (FDA 1999). Recovery and lifespan results between components stored for 6 and 7 days will~     also be assessed.~   "
69792|NCT02653430|"~     This is a long-term follow-up and interventional study in individuals who have been diagnosed~     with moderate to severe obesity with or without diabetes. The purpose of this study is to~     determine the effects of sleeve gastrectomy on weight and blood sugar control and underlying~     mechanisms by metabolomics, metagenomics, functional magnetic resonance imaging (fMRI)~     ,adipose tissue expression chip and etc.~   "
69793|NCT02653417|"~     The purpose of this study is to determine the clinical safety of and whether RAD1901 reduces~     the frequency and severity of VMS in postmenopausal women regardless of uterine status.~   "
69794|NCT02653404|"~     The aim of this project is to analyze the potential contribution of IGRA test QuantiFERON-TB~     Gold In Tube test (QTF-GIT, Cellestis Limited, Carnegie, Victoria, Australia) in the~     diagnosis of tuberculosis (TB - active or latent) in pediatric subjects (0 and 17 year)s~     recently exposed to infection (indicated as contacts) or with clinical suspicion of active~     TB, and to compare the results obtained with those of the TuberculinSkin Test (TST; gold~     standard). The project is expected to enroll up to 50 pediatric patients over a 4-year study.~     Children with access to Ambulatory structures or hospitalized at University Infectious~     Diseases Clinic or Pediatric Clinic, University Hospital of Siena, or with access to~     Ambulatory or hospitalized at Pediatric Clinic USL 9 Grosseto will be enrolled. Once obtained~     the informed consent of patients' parents or legal guardians, patients will be enrolled. The~     doctor will administer a clinical-anamnestic questionnaire, relative to the country of birth~     and residence, date of arrival in Italy and any stays in the country of origin (in case of~     foreign patient), travels abroad, risk factors for infectious diseases, type of contact with~     any index case, previous vaccination with BCG, date and outcome of the TST, clinical symptoms~     and signs suggestive of active TB, report of any instrumental investigation. Together with~     the collection of blood samples for routine purposes, an additional blood sample will be~     taken so to run IGRA test. Also patients for whom their medical doctor will independently~     order to run QTF-GIT test as necessary tool for the clinical diagnosis of TB will be included~     in the study.~      A retrospective analysis will be performed on patient pertaining to participant Clinics, from~     1 January 2012 to 31 May 2015. Such analysis will be performed on those patients for which~     their medical doctor requested both intradermal Mantoux and IGRA test.~      Expected results:~        -  estimation of concordance between QuantiFERON-TB Gold In Tube and TST in pediatric~          patients exposed to TB, with or without latent TB infection~        -  Evaluation of the sensitivity of the test QTF-GIT in patients with active tuberculosis~          disease~        -  Evaluation of specificity of testQTF-GIT in not infected patients~        -  Evaluation on the possible use of QTF-GIT, together with TST, to improve the diagnosis~          of tuberculosis latent or active infection in pediatric subjects.~        -  Evaluation of the possible diagnostic use of QTF-GIT in the child <5 years.~   "
69795|NCT02653391|"~     This is a Phase 1/2 trial in two parts. Part A is a prospective, randomized, double-masked,~     vehicle controlled, paired-eye study in approximately 16 subjects to evaluate safety,~     tolerability and efficacy of elamipretide 1.0% topical ophthalmic solution in patients with~     FCED presenting with mild to moderate corneal edema. Part B is a prospective, randomized~     double-masked, vehicle controlled study in approximately 11 subjects to evaluate safety,~     tolerability, and efficacy of elamipretide 3.0% topical ophthalmic solution in patients with~     FCED presenting with mild to moderate corneal edema.~   "
69796|NCT02653378|"~     The purpose of this study is to determine how the modality of energy depletion can~     differently impact appetite hormones, ad libitum food intake, food hedonics, and olfaction.~   "
69797|NCT02653365|"~     The aims of our study was to identify early predictors of non-invasive ventilation failure,~     so as to alert clinicians early that endotracheal intubation and mechanical ventilation might~     be appropriate.~   "
69798|NCT02653352|"~     The purpose of this study was to encourage students to reduce soft drinks intake,~     substituting it by water, in order to prevent and control overweight prevalence.~   "
69799|NCT02653339|"~     This is a controlled clinical trials about traditional Chinese medicine named Qufeng Shengshi~     Fang，which consisted of cicada slough，bombyx batryticatus，radix angelicae，radix~     sileris，honeysuckle flower，forsythia，lithospermum and radix glycyrrhizae，and Loratadine on~     treatment of Allergic Rhinitis.There are 180 Patients with allergic rhinitis recruited from~     Department of Allergy and Traditional Chinese.To carry on statistical analysis of the result~     of the self and between-group cross-reference by two questionnaires filled before and after~     treatment.~   "
69800|NCT02653326|"~     In this randomised, double-blind, pilot study, the investigators aim to assess whether a~     telerehabilitation strategy could improve outcomes among patients with recent heart surgery.~     Included participants will receive a comprehensive rehabilitation programme comprised of~     physical therapy, nutritional counselling, psychological assistance in addition to standard~     medical care. After 12 sessions of physical therapy, patients will be randomised to receive~     telerehabilitation with a portable EKG device and a smartphone application or usual care. The~     primary endpoint for this study is the exercise capacity of included participants, which will~     be assessed using an ergospirometer at 4 and 8 weeks after randomisation.~   "
69801|NCT02653313|"~     Investigation on safety, tolerability and efficacy of parvovirus H-1 (ParvOryx) in subjects~     suffering from metastatic, inoperable pancreatic cancer with at least one hepatic metastasis.~   "
69802|NCT02653300|"~     This is an open, pilot study using the oral ORMD-0801 insulin formulation in patients with~     NASH and confirmed type 2 DM or pre-diabetes. The study will consist of a Screening, placebo~     run-in, treatment phase and end-of-study phase.~   "
69803|NCT02653287|"~     Participants in the Chicago Lupus Database or individuals seen at Northwestern Medicine will~     be approached to enroll in a one year clinical trial looking at decreasing fatigue in persons~     with systemic lupus erythematosus (SLE). The intervention group will receive individual~     coaching and group educational sessions focusing on physical activity and nutrition while the~     control group will receive individual calls in relation to SLE self-management group~     educational sessions.This study is designed to evaluate the LIFT intervention to decrease~     fatigue (primary outcome), improve physical activity (secondary outcome) and dietary behavior~     (exploratory outcome) in persons with SLE.~   "
69811|NCT02653183|"~     The primary objective of this investigation is to evaluate if complications related to~     surgical wound are more common in the treatment group compared to the control group starting~     from operation day until last visit.~      The secondary objectives are to evaluate:~        -  the performance of the dressing~        -  the comfort, conformability and the acceptability of the dressing~        -  pain before and during dressing removal on the last visit~   "
69824|NCT02653001|"~     The aim of this project is to establish a list of volunteers willing and able to donate stool~     samples for use in the model colon so as to facilitate research directed toward understanding~     the basic science underlying the interactions between the gut microbiome, potential external~     modifiers, and health.~   "
69849|NCT02652676|"~     The purpose of this study is to: 1) Remodel and restore left ventricular geometry and~     function. 2) Avoid the need for mechanical circulatory support (MCS) and/or cardiac~     transplantation (CT). 3) Confirm the outcomes of a pilot study completed in Germany and~     reported in The Journal of Heart and Lung Transplantation in May 2013.~   "
69804|NCT02653274|"~     Breakfast porridges are made from milled grains and are commonly eaten worldwide.~     Traditionally different grains are used in different countries. For example, oats are more~     common in the Anglo-Saxon countries; rye is favoured in the Scandinavian countries whilst~     millet is very common in parts of India and Africa. However the nutritional value and~     potential metabolic and health effects may vary dramatically between different grains. For~     example what is the effect of the different grains on blood sugar or on how fast the stomach~     empties after eating the porridge and how full people feel. All these physiological responses~     may differ between these grains resulting in potential health benefits.~      RESEARCH QUESTION: The investigators hypothesise that porridges made from different grains~     will behave differently during the digestion and cause differences in blood glucose levels,~     gastric emptying and appetite.~      This study, which is a 4-way, randomized, cross over pilot study in healthy participants,~     aims to answer this research question.~      The participants will be asked to eat a porridge breakfasts made with oats, rye and millet of~     different varieties (but containing the same amount of calories), in 4 morning studies one~     week apart. MRI will be used to monitor the gastrointestinal fate of the breakfasts and~     measure gastric emptying using MRI, blood glucose levels using a finger prick test and~     self-reported appetite scores.~   "
69805|NCT02653261|"~     Transurethral resection of the prostate (TURP) represents the gold standard in the operative~     management of benign prostatic hyperplasia (BPH) and the transurethral resection of bladder~     tumor (TURBT) is the first-line surgical treatment for bladder tumors. One of the most~     important complications of urological endoscopic resections is intraoperative and~     postoperative bleeding requiring blood transfusion. Allogeneic blood transfusion is not free~     of risks, like infection transmission, hemolytic reactions, transfusion-related lung injury,~     fluid overload, increased costs and hospital length of stay.~      Tranexamic acid (TXA) is a synthetic analog of serin than reversibly inhibits fibrinolysis by~     blocking lysine union sites in the plasmin and plasminogen activator molecules. TXA has been~     used to reduce blood loss and the need for allogeneic blood transfusion in cardiac surgery~     and orthopedic surgical procedures but few studies have assessed the efficacy of this~     antifibrinolytic agent in urological endoscopic procedures.~      The investigators designed this double-blind, placebo controlled study evaluate the safety~     and efficacy of the antifibrinolytic agent tranexamic acid in reducing blood transfusion in~     patients undergoing endoscopic surgery in urology.~   "
69806|NCT02653248|"~     Stereotactic Body Radiation Therapy (SBRT) is a method of delivering radiation which can~     target the tumor more precisely and cause less damage to normal tissue. This is a Phase I~     research study looking at the safety of the dose of SBRT in organ confined prostate cancer.~   "
69807|NCT02653235|"~     Acquiring, processing and utilising information is crucial to any mental function~     -including seemingly simple daily functions. Collectively called 'cognitive functions', these~     processes are a result of different regions of the brain acting together.~      Disruption of these cognitive functions increases the risk of development of mental health~     problem. Recently it has been proposed that inflammatory pathways may contribute to disorders~     of cognition and behaviour like depression.~      This is largely due to research showing that those with inflammatory conditions like~     arthritis are more likely to develop mental health problems like depression. Conversely,~     those who suffer from mental health problems (even in the absence of inflammatory conditions)~     have large amounts of inflammatory molecules in the blood. Studies in animals suggest that~     inflammation outside the brain can reach and affect the brain in a number of ways. So, does~     inflammation play a role in the development of cognitive and behavioural symptoms? What are~     the pathways involved?~      The current project tries to address this question. Specifically, the investigators intend to~     use modern scanning techniques to examine the effect of inducing a low grade inflammation~     (using a commonly used typhoid vaccine) to see how the inflammation affects how different~     regions of the act together to perform cognitive functions.~   "
69808|NCT02653222|"~     In this study the investigators are going to assess the feasibility of this innovate~     technique of renal sympathetic denervation by translumbar access under ct-guidance.~      To limit the potential impact on the kidney, the investigators chose a population of chronic~     renal failure patients on dialysis or renal transplant (with native kidneys still present)~     and having resistant treatment hypertension despite antihypertensive combination therapy well~     conducted.~      The investigators expect to obtain a decrease of the blood pressure at the 24-hours~     ambulatory blood pressure monitoring (ABPM) one month after the sympathetic denervation.~   "
69809|NCT02653209|"~     The aim of this project is to identify subgroups of patients with type 2 diabetes that~     respond well or poorly to particular drugs based on particular clinical characteristics such~     as their weight or kidney function, to enable better targeting of treatment for a particular~     individual.~      This study will test 2 hypotheses of drug response supported by routine clinical and trial~     data. 600 patients with type 2 diabetes who have suboptimal glycaemic control on dual oral~     therapy will be recruited to a randomised double-blind crossover study of a DPP4 inhibitor,~     SGLT2 inhibitor and thiazolidinedione. Each patient will take each study drug in addition to~     their existing treatment for four months at a time. At the end of each treatment the~     patient's glucose control will be measured and information about their experience of the drug~     will be collected.~   "
69810|NCT02653196|"~     There is currently no standard treatment for patients with neuro-epithelial (brain) or other~     solid tumors in another part of the body who do not have adequate suitable autologous~     hematopoietic progenitor cells available and/or whose disease has relapsed after standard~     treatment. Allogeneic Hematopoietic Progenitor Cell Transplant may be a consideration for~     treatment of patients with recurrent chemo-responsive malignant (high grade) neuro-epithelial~     and other solid tumors or those who do not have suitable autologous hematopoietic progenitor~     cell availability. The procedure in which your own blood stem cells are transplanted to you~     is called an autologous (from your own) progenitor cell transplant and when cells from a~     matched donor are transfused is called an allogeneic progenitor cell transplant. The study is~     being conducted to evaluate the safety and effectiveness of a combination of drugs followed~     by an allogeneic hematopoietic progenitor cell transplant (HPCT). This treatment regimen is~     experimental in that although the individual drugs are commonly used to treat your disease,~     the specific combination used in this protocol followed by the transplant is experimental.~   "
69812|NCT02653170|"~     The Michigan Stroke Transitions Trial (MISTT) is a patient-centered randomized control trial~     that aims to improve the experience of stroke patients after they return home. The MISTT~     study will test the effect of two complementary interventions against usual care. The two~     interventions include: a) Stroke Case Managers (SCMs) who are trained social workers, and b)~     an online informational website or portal. The 12 week intervention period begins when the~     stroke patient returns home from the hospital or rehab facility. The SCMs will conduct at~     least 2 home visits with the patient (one within 3-4 days and one around 30 days) along with~     weekly follow-up telephone calls. Supplemental home visits will be used as necessary over the~     12 week period. At the first home visit the social workers will conduct a comprehensive~     in-home assessment and link patients and caregivers to local resources as necessary. Patients~     also assigned to the website will have access to a patient-centered online information and~     support resource called the Virtual Stroke Support Portal (VSSP). The investigators~     hypothesize that this personalized case management program will reduce patient and caregiver~     needs, improve quality of life, and decrease caregiver stress. The MISTT study will enroll~     315 acute stroke patients discharged from 3 Michigan hospitals and will be completed by the~     end of 2017.~   "
69813|NCT02653157|"~     This is a prospective observational study to determine the role of colonization and identify~     the timing of development of drug resistance in multidrug resistant Gram-negative bacilli~     (MDR-GNB) causing infection among critically ill burn patients.~   "
69814|NCT02653144|"~     The purpose of the study is to determine if perineural dexmedetomidine can provide increased~     prolongation of analgesia when compared to perineural dexamethasone in patients receiving~     regional block for shoulder surgery. If so, dexmedetomidine may serve as a superior adjunct~     to peripheral nerve blocks in a rapidly evolving, ambulatory-centered surgical setting.~   "
69815|NCT02653131|"~     The inhibition of Dipeptidyl peptidase-4 should increase the concentration of glucagone-like~     peptide 1 and 2, and the increase of the latter should increase the absorptive capacity of~     the intestine.~   "
69816|NCT02653118|"~     Protocol V503-021 is a long-term follow-up study of the V503-001 base study (NCT00543543) to~     evaluate the safety, immunogenicity, and long-term effectiveness of V503 vaccine in~     preventing cervical cancer and related precancers caused by human papillomavirus (HPV) types~     16, 18, 31, 33, 45, 52, and 58. Because of the high retention of V503-001 participants from~     the Nordic countries, and the highly efficient screening and surveillance system there, study~     V503-021 will evaluate only participants from V503-001 sites in Denmark, Norway, and Sweden.~     The hypothesis being tested is that V503 vaccine will remain effective for at least 14 years~     after the start of vaccination.~   "
69817|NCT02653105|"~     Does the olfactomédine provide an help to limit the number of false positives in the overall~     imaging balance and limit the number of unnecessary biopsies?~   "
69818|NCT02653092|"~     Obesity plays an adverse role at every stage of conception and pregnancy and mounting~     evidence implicates relative hypogonadotropic hypogonadism, and reduced menstrual cycle~     hormone secretion as likely contributors to the subfertility phenotype and possible~     contributors to complications of pregnancy and the developmental origin of adult diseases~     such as diabetes and cardiovascular disease. This study will be the first comprehensive~     investigation to tie together the patterns of hyperinsulinemia, hyperlipidemia and~     inflammation, characteristic of obesity and obesity-caused relative hypogonadotropic~     hypogonadotropism and its potential adverse reproductive outcomes. The investigators findings~     will be used to inform a subsequent clinical intervention to optimize reproductive outcomes~     for obese women and their offspring.~   "
69819|NCT02653079|"~     Patients suffering from chronic degenerating diseases are often treated by a plethora of~     NSAIDs, DMARDs, Biologicals, as well as combinations of these therapeutics. However, many~     patients are refractory to this treatment and suffer from chronic pain over years, leading to~     a worsening of the quality of live. The mobilization of these patients is one main goal in~     the therapy of these chronic and inflammatory diseases. Low dose radiation therapy (LDRT) is~     applied since more than one century for the local treatment of chronic degenerating joint~     diseases. The success of the treatment was described by many retrospective as well as pattern~     of care studies, respectively.~      Local (only at the painful joint) low dose irradiation of the chronic patients results in~     most patients in a significantly reduced pain, not only direct after the therapy, but also~     lasting for more than 12 month in many cases. The patients experience enhanced mobility and~     increased quality of life. The molecular and cellular processes leading to the pain reduction~     are just fragmentarily analyzed. Our group revealed that macrophages are key players in~     radiation-induced immune modulation. Inflammatory macrophages exposed to low doses of~     radiation showed a reduced inflammatory capacity and attenuated an inflammatory~     microenvironment. Besides macrophages further immune cells are most likely involved in~     reduction of inflammation following LD-RT, as in vitro already shown for neutrophils.~      The IMMO-LDRT01 study aims for the first time to analyze in detail the immune status of~     patients suffering from inflammatory, chronic joint diseases before, during and after LD-RT~     in a longitudinal manner. The multi-color flow cytometry-based assay will allow determining~     over 30 immune cell subsets and additionally their activation status. Further, biodosimetry~     will be performed with the whole-blood samples to get hints about dose that the immune cells~     are exposed to. This will be performed with national and international co-operation partners.~      The IMMO-LDRT01 study is a prospective and observational study not influencing the standard~     therapeutic scheme and will provide hints how the LDRT affects besides local cells in the~     irradiated area also the systemic inflammatory response.~   "
69820|NCT02653066|"~     The purpose of this research is to study the utility of using the HealtheRx as a tool to~     recruit eligible patients into the Pulmonary Research Registry (PRR) (IRB 15543B) at the~     University of Chicago. HealtheRx is an example of a potential recruitment tool that has high~     reach in populations typically underrepresented in research studies, uses a high tech~     infrastructure that allows matching of research opportunities to patient characteristics, but~     that delivers information in a low-tech, patient-centered mode using the printed HealtheRx~     prescription.~   "
69821|NCT02653040|"~     The purpose of this pilot study is to evaluate wether a naturalistic indoor light environment~     can improve sleep and mood in psychiatric inpatients~   "
69822|NCT02653027|"~     The purpose of this research study is to find out if the combined therapy~     lumacaftor-ivacaftor effects how people with cystic fibrosis respond to an oral glucose~     tolerance test, a test for diabetes.~   "
69823|NCT02653014|"~     This multiple ascending dose (MAD) study in healthy subjects and subjects with mild to~     moderate renal impairment will evaluate the safety, tolerability and pharmacokinetics of~     KBP-5074. Safety/tolerability data and Pharmacokinetics (PK)/Pharmacodynamics (PD) (plasma~     aldosterone, serum potassium, UACR and Blood Pressure) relationships will be explored to~     support the selection of dosing regimens of KBP-5074 that are suitable for the Phase II/III~     study.~   "
70049|NCT02650076|"~     The primary objective is to confirm the target receptor occupancy of SK-1405 and to correlate~     receptor occupancy with SK-1405 dose and plasma concentration.~      The secondary objective is to assess the safety and tolerability of SK-1405 in healthy,~     Caucasian, male subjects.~   "
69825|NCT02652988|"~     In this phase II, randomized, double-blind clinical trial, the investigators intended to~     evaluate the home-based effect of transcranial direct current stimulation (tDCS) in patients~     with fibromyalgia. This syndrome affects between 3-5% of the population in an age group 40-60~     years also occurring in childhood and old age. Reaches 3.4% of women and 0.5% of men.~     Fibromyalgia is a chronic widespread pain syndrome in various parts of the body. The~     neuromodulation techniques have as a principle produce inhibition or cortical arousal. The~     tDCS is a non-invasive brain stimulation method used to modulate the cortical excitability,~     using a low intensity direct current (1-2mA) directed to the scalp via the cathode and anode~     electrodes. The current reaches the cortex, producing hyperpolarization or depolarization of~     the axonal membrane potential. Evidence has shown that this method is presented as a~     technique able to alter cortical and subcortical neural networks. This technique has been~     used to treat psychiatric disorders such as depression, acute mania, bipolar affective~     disorder, panic, hallucinations, obsessive compulsive disorder, schizophrenia, withdrawal,~     rehabilitation after stroke, pain syndromes such as neuropathic pain, migraine, pancreatitis~     pain chronic and fibromyalgia. The tDCS is a low cost technique, with virtually no side~     effects and which exerts therapeutic effect by neuromodulatory pathways by distinct pathways~     activated by the drugs. In this scenario falls within the importance of developing this~     device for home use by fibromyalgia patients, since it is easy to use and thereby enables~     maintaining the benefit observed in studies performed and supervised frequently used in care~     centers. The use of tDCS over the long term is not feasible in hospital by patients demands,~     sometimes every day or more than once a week, removing the patient from their activities, and~     cost shifting and overload the healthcare system. Therefore, the objective of this study is~     to evaluate the effect of home-based tDCS in fibromyalgia patients in long-term treatment.~   "
69826|NCT02652975|"~     Several cytotoxic regimens are related to endothelial cell damage and vascular toxicity.~     Endothelial dysfunction is implicated in the pathogenesis of all known cardiovascular~     diseases (CVD) and closely related to the metabolic syndrome. Both CVD and diabetes~     contributes importantly to total mortality and to breast cancer (BC) specific mortality.~      In the epidemiological part of the project, the investigators will determine the prevalence~     and incidence of cardiovascular and metabolic morbidity/mortality in early BC patients~     compared to the Danish background population.~      In the clinical part, the investigators will study the changes of endothelial function and~     metabolic parameters in BC patients receiving chemotherapy.~      With increasing number of BC survivors, long-term consequences of curative cancer treatment~     should be studied. The investigators hypothesize that cytotoxic therapy worsens metabolic~     parameters possibly through endothelial dysfunction. If this is true, the next step will be~     to evaluate how strict metabolic control will affect prognosis.~   "
69827|NCT02652962|"~     The purpose of this study is to determine the safety and tolerability of Gelesis200.~   "
69828|NCT02652949|"~     The purpose of the Valiant Evo US Clinical Trial is to demonstrate the safety and~     effectiveness of the Valiant Evo Thoracic Stent Graft System in subjects with a descending~     thoracic aortic aneurysm (DTAA) who are candidates for endovascular repair.~   "
69829|NCT02652936|"~     This is a 2-part, single centre, single (Part 1) and multiple (Part 2) dose escalation study~     in healthy male subjects.~   "
69830|NCT02652923|"~     This is a two part, open label, non-randomized trial of women with a breast cancer diagnosis~     scheduled for excisional surgery and sentinel lymph node (SLN) evaluation.~      Part 1 is a two-period, crossover, dose-finding study, which will be performed in 12 healthy~     female volunteers to determine the optimal dose as well as the safety and tolerability of the~     tissue-specific, contrast agent Sonazoid (GE Healthcare, Oslo, Norway) for human lymphatic~     applications. In Part 2 lymphosonographic SLN identification will be compared to that of~     isotope mapping during surgery on 90 female, breast cancer patients.~   "
69831|NCT02652910|"~     The goal of this clinical trial is to study how approaches for manufacturing chimeric antigen~     receptor (CAR)-modified T (CAR-T) cells affect their in vivo persistence and therapeutic~     efficacy against B lymphoma. Recently, cancer immunotherapy, treatments aiming to arm~     patients with immunity specifically against cancer cells, has emerged as a promising~     therapeutic strategy. Among the many emerging immunotherapeutic approaches, clinical trials~     utilizing CARs against B cell malignancies have demonstrated remarkable potential. CARs~     combine the variable region of an antibody with T-cell signaling moieties to confer T-cell~     activation with the targeting specificity of an antibody. Thus, CARs are not MHC-restricted~     so they are not vulnerable to MHC down regulation by tumors. However, defined by the~     activation and contraction program of their mother cells, the persistency and function of~     CAR-T cells are also restricted by the protocol of manufacturing. Previous clinical studies~     largely utilized interleukin-2 (IL-2) for the ex vivo expansion of CAR-T cells, which~     preferentially generate CAR-T cells with characteristics of terminally differentiated~     effector cells. Our preliminary data indicated that two common gamma chain cytokines, IL-7~     and IL-15, can help to selectively expand CAR-T cells with various memory phenotypes. CAR-T~     Cells prepared under this condition resulted in improved therapeutic efficacy in preclinical~     animal models. This clinical investigation is to test a hypothesis whether~     IL-7/IL-15-programmed anti-CD19 CAR-T cells persist longer in lymphoma patients after~     infusion and whether the persistency of CAR-T cells can lead to improved anti-lymphoma~     efficacy.~   "
69832|NCT02652897|"~     Prospective, observational study aimed to investigate the specific hemostatic alterations in~     patients undergoing glial tumor resection.~   "
69833|NCT02652884|"~     The incidence of thyroid cancer (TC) has increased exponentially worldwide. The increase in~     diagnosed cases brings about an increase in the number of surgeries performed on the thyroid~     gland, especially total thyroidectomy (TT), given that at present is still the gold standard~     of treatment.~      Transient postoperative hypoparathyroidism (HPT) is one of the most frequent complications,~     with an incidence of between 10 and 46% according to different sources. HPT involves longer~     hospital stay, serial measurements of blood glucose, treatment with calcium and vitamin D~     (with potential risk of hypercalcemia) and therefore an increase in terms of the costs of the~     health system.~      While the investigators know the analgesic, anti-inflammatory, immunomodulatory and anti~     emetic of corticosteroids in thyroid surgery, the literature available to date is discordant~     in the use of steroid and its interaction with the HPT making clear the need for randomized~     clinical trials specific to analyze these variables more accurately.~      As inflammation and edema constitute a proposed surgical manipulation in the pathogenesis of~     HPT component, investigators decided t conduct a prospective randomized, triple-blind, in~     order to assess the potential benefits of the most common postoperative complication reported~     in TT.~      Our primary objective is to evaluate the safety and efficacy of single-dose corticosteroids~     deposit immediately postintubation in preventing the development of transient~     hypoparathyroidism (PTH, serum calcium and symptoms) in patients after TT.~   "
69834|NCT02652871|"~     The goal of this clinical research study is to learn about the safety of LY2510924 in~     combination with cytarabine and idarubicin in patients with relapsed or refractory AML. We~     will also study if LY2510924 in combination with cytarabine and idarubicin can help to~     control relapsed or refractory AML.~      LY2510924 is designed to help cancer cells move from the bone marrow into the bloodstream,~     where they are exposed to chemotherapy (in this case, cytarabine and idarubicin).~      This is an investigational study. LY2510924 is not FDA approved or commercially available.~     Its use in this study is investigational. Cytarabine and idarubicin are approved to treat~     certain types of leukemia. Their use in this study in combination with LY2510924 is~     investigational.~      Up to 36 patients will take part in this study. All will be enrolled at MD Anderson.~   "
69835|NCT02652858|"~     Central and peripheral arterial pressure decoupling occurs in some clinical conditions like~     sepsis or cardiopulmonary bypass. This decoupling may leed to unsuitable decisions such as~     the use of catecholamines.~      The aim of this study is to evaluate the pulse wave's speed as a marker of central and~     peripheral arterial pressure decoupling in a scheduled condition which is the cardiopulmonary~     bypass during cardiac surgery.~   "
69836|NCT02652845|"~     This study tests the feasibility of a health and wellness trial designed with community~     input. This 12-week program will be tested over a 24-week period using a delayed treatment~     control group.~   "
69837|NCT02652832|"~     The aim of this study is to investigate the effects of non invasive brain stimulation - NIBS~     - techniques (Electroconvulsivotherapy - ECT, transcranial Direct Current Stimulation - tDCS,~     repetitive transcranial magnetic stimulation - rTMS) on serum Brain Derived Neurotrophic~     factor (BDNF) levels in patients with depression and schizophrenia. Four blood samples will~     be collected in each participants, one before the NIBS sessions, and 3 after the completion~     of NIBS protocols: one immediately after the end of the NIBS sessions, a second one week~     after and a last one month after. Two blood samples separated by one month will also be~     collected in a a group of healthy volunteers.~   "
69838|NCT02652819|"~     This is a randomized, multicenter, double-blind, placebo-controlled study of the treatment of~     anemia in subjects with CKD not on dialysis, with treatment up to 52 weeks.~   "
69839|NCT02652806|"~     This is a randomized, multicenter, open-label, active-controlled study of the treatment of~     anemia in subjects with CKD on dialysis, with treatment up to 52 weeks.~   "
69840|NCT02652793|"~     A 48-week, open label, non comparative prospective trial in stable chronic human~     immunodeficiency virus-infected patients having achieved complete virological suppression for~     more than 24 weeks (human immunodeficiency virus-1 RNA <50 c/ml) switching from an~     antiretroviral regimen containing tenofovir and lamivudine or emtricitabine and boosted~     protease inhibitor to boosted atazanavir and lamivudine Study visits will take place at~     screening, baseline, weeks 4, 12, 24, and 48.~   "
69841|NCT02652780|"~     The goal of this clinical trial is to assess the effectiveness of GS010, a gene therapy, in~     improving the visual outcome in patients with LHON due to the G11778A ND4 mitochondrial~     mutation when vision loss is present for more than six months and up to one year.~   "
69842|NCT02652767|"~     The goal of this clinical trial is to assess the effectiveness of GS010, a gene therapy, in~     improving the visual outcome in patients with LHON due to the G11778A ND4 mitochondrial~     mutation when vision loss is present for six months or less.~   "
69843|NCT02652754|"~     The purpose of this study is to determine the systemic exposure of Granexin® gel after~     topical application to human subjects' diabetic foot ulcers.~   "
69844|NCT02652741|"~     Paediatric clinical trial in 50 children, from newborn to less than 6 years of age, suffering~     from heart failure due to congenital heart disease, to obtain paediatric pharmacokinetic and~     pharmacodynamic data of enalapril and its active metabolite enalaprilat while treated for 8~     weeks with enalapril in form of Orodispersible Minitablets (ODMTs), to describe the dose~     exposure in this patient population.~   "
69845|NCT02652728|"~     Paediatric clinical trial in 50 children, from 1 month to less than 12 years of age,~     suffering from heart failure due to dilated cardiomyopathy, to obtain paediatric~     pharmacokinetic and pharmacodynamic data of enalapril and its active metabolite enalaprilat~     while treated for 8 weeks with enalapril in form of Orodispersible Minitablets (ODMTs), to~     describe the dose exposure in this patient population.~   "
69846|NCT02652715|"~     This pilot clinical trial studies Salvia hispanica seed in reducing the risk of returning~     disease (recurrence) in patients with non-Hodgkin lymphoma. Functional foods, such as Salvia~     hispanica seed, has health benefits beyond basic nutrition by reducing disease risk and~     promoting optimal health. Salvia hispanica seed contains essential poly-unsaturated fatty~     acids, including omega 3 alpha linoleic acid and omega 6 linoleic acid; it also contains high~     levels of antioxidants and dietary soluble fiber. Salvia hispanica seed may raise omega-3~     levels in the blood and/or change the bacterial populations that live in the digestive system~     and reduce the risk of disease recurrence in patients with non-Hodgkin lymphoma.~   "
69847|NCT02652702|"~     Conventional hand-stitching colostomy involves extensive hand-stitching by the surgeon. There~     are significant variations in the outcome of surgery due to differences in the suture~     techniques of surgeons. The use of a circular stapler in colostomy seems more rapid and~     efficient colostomy than the conventional methods.But all those reports are single center~     retrospective cohort study，no randomized controlled trials have been carried out so far.The~     aim of this study is to comparing the safety and efficiency of circular stapler-assisted~     colostomy with conventional hand-stitching colostomy in patients with colorectal carcinoma.~   "
69848|NCT02652689|"~     The LDS may contain information of significant diagnostic and physiological value regarding~     the pulmonary parenchyma and vasculature, as well as the cardio- vascular system in general.~     In pilot clinical studies of patients with acute decompensated heart failure (ADHF) as well~     as patients with Pulmonary Hypertension, LDS signals patterns unique to these conditions were~     identified. We believe that these newly discovered ultrasound signals might provide a~     non-invasive radiation-free means to diagnose and monitor patients with Pulmonary Embolism.~      The purpose of this study is to assess the utility of noninvasive assessment of lung Doppler~     signals performed via transthoracic parametric Doppler. The objective of the study is to~     evaluate the lung Doppler signals (LDS) in patients diagnosed with acute PE, in order to~     determine the potential assessment value of this non-invasive method in this potentially life~     threatening condition.~   "
69850|NCT02652663|"~     Magnetic resonance imaging (MRI) has been widely used for problem-solving tool in the~     evaluation of hepatic lesions, and it has been shown to have better sensitivity than CT for~     detection of colorectal liver metastases, especially for lesions which are smaller than 1 cm.~     After introduction of a liver-specific hepatobiliary MR contrast agent, gadoxetic acid,~     gadoxetic acid-enhanced MRI (Gd-EOB-MRI) has been increasingly used for evaluation of liver~     lesion including CRLM. However, compared to conventional MRI with extracellular contrast~     agent (ECA-MRI), Gd-EOB-MRI has different pharmacodynamic characteristics, and is more~     expensive due to higher cost of gadoxetic acid and needs longer scan time to obtain~     hepatobiliary phase which is generally acquired 15 to 20 minutes after contrast injection.~     The purpose of this study was to compare the clinical outcome and diagnostic performance of~     Gd-EOB-MRI and ECA-MRI for evaluation of focal hepatic lesion in newly diagnosed colorectal~     cancer.~   "
69851|NCT02652650|"~     The purpose of this study is to evaluate the effect of steady-state concentrations of~     JNJ-63623872 on the steady-state pharmacokinetics of ethinylestradiol and norethindrone in~     healthy female participants.~   "
69852|NCT02652637|"~     Enchanced recovery after surgery (ERAS) protocols aim to provide safer and quicker recovery~     postoperatively. One of the elements in ERAS protocols is that bowel is not prepared before~     colorectal surgery. However, several recent retrospective register studies have suggested~     that mechanical bowel preparation combined to oral antibiotics before colectomy reduces~     complications compared to no preparation at all. This trial compares these two strategies to~     find out whether complications can indeed be reduced by mechanically preparing the bowel with~     oral antibiotics.~   "
69853|NCT02652624|"~     This study will evaluate the efficacy of switching to a fixed-dose combination (FDC) of~     bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing on a regimen~     consisting of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF),~     elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF), or~     atazanavir (ATV) + ritonavir (RTV) + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in~     virologically suppressed HIV-1 infected women.~   "
69854|NCT02652611|"~     Chronic pain following surgical stabilization of a pelvic fracture is very prominent and can~     have a major affect on a patient's quality of life. Persistent pain after radiographic~     evidence of fracture union commonly leads to implant removal. But, the routine removal of~     orthopaedic fixation devices after fracture healing remains an issue of debate.~   "
69855|NCT02652598|"~     The experimental design is an open-label two-week trial of tolcapone to evaluate which~     clinical domains are affected by tolcapone treatment and to identify responders to~     tolcapone treatment in the two subject groups (BI and NCD)~   "
69856|NCT02652585|"~     Using theTEMA (test system for development of medications for alcoholism) it can be shown,~     that naltrexone administration reduces the willingness to perform work for alcohol infusion~     in a laboratory experiment.~   "
69857|NCT02652572|"~     The purpose of this study is to determine the systemic exposure of Granexin® gel after~     topical application to human subjects' venous leg ulcers.~   "
69858|NCT02652559|"~     Rationale:~      Application of long-term non-invasive ventilation (NIV) in stable chronic obstructive~     pulmonary disease (COPD) patients with chronic hypercapnic respiratory failure (CHRF) has~     recently been shown to improve survival and quality of life when applied with sufficiently~     high inspiratory pressures and adequate backup breathing frequencies (so called~     high-intensity NIV). However, for a broader implementation of this therapy in a potentially~     large group of patients, important issues have to be solved. First, the initiation of~     high-intensity NIV, currently performed in the hospital, is often time-consuming, expensive~     and inconvenient for patients. Secondly, although clinicians recognise that not all patients~     benefit, it is not known which factors predict a positive response.~      Objectives:~        1. To investigate whether home initiation of chronic NIV in stable COPD patients with CHRF~          is non-inferior to inpatient initiation.~        2. To investigate predictors of a favourable response to chronic NIV in COPD patients with~          CHRF.~      Study design:~      The study is 1:1 two-arm parallel group randomised controlled trial comparing the usual~     inpatient NIV initiation to home initiation.~      Study population: Seventy-two COPD patients with a NIV indication (COPD GOLD stage III or IV;~     partial arterial carbon dioxide pressure (PaCO2) > 6.0 kPa in stable condition, i.e. no COPD~     exacerbation for 4 weeks and a pH > 7.35), a sufficient social network at home, without~     severe cardiac comorbidities, will be included.~      Intervention: Home initiation of NIV will be compared with standard in-hospital initiation.~     NIV at home will be titrated by a specialised nurse of our home mechanical ventilation centre~     (HMV) on transcutaneously measured gas exchange and respiratory electromyography and will be~     adjusted with the use of telemedicine.~      Main study parameters/endpoints:~        1. To investigate non-inferiority of home initiation, the change in arterial carbon dioxide~          pressure after 3 months treatment will be the primary outcome. Secondary outcomes are~          safety, change in lung function, health-related quality of life (HRQoL) and costs.~        2. To investigate predictors of a favourable response, patient demographics, and baseline~          data on lung function as well as measures of respiratory muscle activity, arterial blood~          gases, comorbidities, inflammatory blood markers and anxiety and depressions scores will~          be collected of all patients.~   "
69859|NCT02652546|"~     Background:~      When there is a threat to the body, the immune system triggers inflammation. Too much~     inflammation can damage the body or cause painful symptoms. Some people with HIV feel sick~     after they start HIV drugs because their recovering immune systems cause too much~     inflammation. Or their immune systems can become activated all the time. This can cause~     serious health problems. Researchers want to test if the drug CC-11050 helps treat~     inflammation in people taking HIV drugs.~      Objectives:~      To test if CC-11050 is safe and well-tolerated for people with HIV who are taking HIV drugs.~     To see if it reduces inflammation.~      Eligibility:~      People ages 18 and older with HIV who have been on antiretroviral therapy for at least 1~     year.~      Design:~      Participants will be screened with:~      Medicine review~      Physical exam and medical history~      Blood and urine tests~      Chest x-ray~      Electrocardiogram (ECG): Soft electrodes on the skin record heart signals.~      Participants will be randomly assigned to take capsules of either CC-11050 or a placebo. They~     will take the capsules every day for 12 weeks. They will continue to take their HIV drugs.~      Participants will have a baseline visit within 2 months of screening. This includes:~      Physical exam and medical history~      Blood and urine tests~      ECG~      Leukapheresis: Blood is removed by a needle in one arm and passed through a machine that~     removes white blood cells. The rest of the blood is returned through a needle in the other~     arm.~      Participants will have follow-up visits 2, 4, 8, 12, and 16 weeks after the baseline visit.~     These may include repeats of some of the baseline tests.~   "
69860|NCT02652533|"~     The investigators plan to investigate the use of US shear wave elastography (SWE), a newly~     available imaging technology, in children with suspected/known BA.~   "
69861|NCT02652520|"~     Kidney transplantation is the treatment of choice for end stage renal diseases, increasing~     life expectancy and quality of life. Improvement in organ preservation is a critical issue in~     this context.~      This is a safety study evaluating the use of an oxygen carrier HEMO2Life® as an additive in~     organ preservation solution in kidney transplantation.~   "
69862|NCT02652507|"~     The purpose of this research study is to examine the effects of two commonly used anesthetic~     drugs, dexmedetomidine and ketamine, have on the shape and muscle tone of the upper airway in~     children, adolescents, and young adults.~      The results of this study will help in making the best decisions regarding the anesthesia~     medications used for sedation outside of the operating room.~   "
69863|NCT02652494|"~     This is a multicenter, prospective, non-interventional, observational single arm study.~      Two-hundred patients will be recruited in the Netherlands over a one year period. In all~     cases, the decision to treat the patient with apremilast will be made prior to the decision~     to enter the subject into this study. Treatment will be according to routine clinical~     practice and based on recommendations as per the SPC of apremilast (Otezla®). Recruitment~     will continue until 200 patients have entered the study. Each patient will be followed for 12~     months.~   "
69864|NCT02652481|"~     The objective of this study is to collect data to confirm the safety and effectiveness of the~     ImageReady™ MR Conditional Defibrillation System when used in the 1.5T MRI environment under~     the labeled Conditions of Use (Phase I).~      Additionally, the study will assess medically necessary MR scans according to the labeled~     Conditions of Use to provide real-world scanning data (Phase I and Phase II).~      The study also aims to demonstrate the continued ability of the ImageReady MR Conditional~     Defibrillation System to sense and detect ventricular fibrillation (VF) post MRI scan by~     collecting and analyzing data from spontaneous VF episodes, for-cause VF inductions, and~     from an optional VF induction Sub-study.~   "
69865|NCT02652468|"~     To determine engraftment of neutrophils and platelets at 28 days following alpha/beta T-cell~     and CD19 cell depletion using HLA haploidentical donors for peripheral blood stem cell~     transplant in relapsed lymphoma.~      Assess incidence of acute GVHD (Graft versus Host Disease), chronic GVHD, graft failure rate,~     treatment related mortality rate, progression free survival and overall survival of patients.~      The stem cell product will be processed using an investigational Miltenyi cell selection~     device/system that removes the alpha/beta T-cells and CD19+ cells, immune system cells that~     are more likely to cause GVHD.~   "
69866|NCT02652455|"~     The purpose of this Pilot Study is to investigate the safety, side effects, and benefits of~     tumor- infiltrating lymphocytes (TILs) when they are given with the drug nivolumab. Nivolumab~     is a type of immunotherapy - a drug that is used to boost the ability of the immune system to~     fight cancer, infection, and other diseases.~      The primary endpoints of this pilot trial will be the safety and feasibility of the treatment~     regimens.~   "
69867|NCT02652442|"~     Recent studies suggest that otolith dysfunction is a common finding in individuals with a~     history of head trauma/blast exposure and/or noise-induced hearing loss. Therefore, otolith~     dysfunction may be a significant health concern for the Veteran population, and determining~     optimal intervention strategies for otolith dysfunction is important for VA healthcare. The~     purpose of this project is to compare the effectiveness of standard vestibular rehabilitation~     compared to a novel treatment approach, centrifugation, in the treatment of individuals with~     otolith dysfunction.~   "
69868|NCT02652429|"~     An Open-Label Long-Term Safety Study of Inhaled Nitric Oxide (iNO) for Pulmonary Arterial~     Hypertension (PAH)~   "
69869|NCT02652416|"~     Safety and tolerability of BI 1026706 in healthy Chinese and Japanese male subjects following~     oral administration of single rising doses (SRD) followed by multiple rising doses (MRD)~   "
69870|NCT02652403|"~     The purpose of this study is to evaluate the effectiveness of a simplified technique of~     conventional dentures fabrication, comparing it to a traditional technique, by evaluating the~     impact of oral health on quality of life, satisfaction of individuals and chewing efficiency~     as well assessing the quality of prosthetics and TMD. Furthermore, the cost involved in the~     manufacture of dentures through technique simplified will be compared to the cost involved in~     the traditional technique.~   "
69871|NCT02652390|"~     Between 2008 and 2012 the investigators performed a single-center randomized double-blind~     placebo-controlled trial to assess the efficacy of local injection of two different doses of~     methylprednisolone (80 mg and 40 mg) in patients with carpal tunnel syndrome (CTS), aged 18~     to 70 years, not previously treated with steroid injection. The primary outcomes were change~     in the CTS symptom severity score at 10 weeks and rate of carpal tunnel release surgery on~     the study hand at 1 year. In the trial 111 patients were randomized (37 in each of the 3~     groups: 80 mg methylprednisolone, 40 mg methylprednisolone and placebo) and all completed the~     1-year follow-up. The investiators plan an extended follow-up 5 to 7 years after injection.~   "
69872|NCT02652377|"~     This randomized, double-blind study will assess the safety, pharmacokinetics and efficacy of~     a single and multiple dose(s) of orally QD administered EDP-494 in healthy volunteers (HV)~     and in treatment-naive subjects with GT1/3 chronic hepatitis C (CHC) infection.~   "
69873|NCT02652364|"~     This study evaluates if strong ion gap on admission or 24 hours after admission to critical~     care unit can predict 28 day outcome in patients admitted with shock due to any cause~   "
69874|NCT02652351|"~     The purpose of this study is to evaluate the safety and efficacy of human umbilical cord~     mesenchymal stem cell(hUC-MSC) for Hepatic Cirrhosis.~   "
69875|NCT02652338|"~     The main aim of this study, which was carried out in two parallel groups, is testing the~     efficacy of a specific micronutrients combination in adults with heart rhythm disturbances~     and accompanying symptoms.~      It is therefore the investigators hypothesis that daily oral administration of the specific~     micronutrients combination will lead to a decrease of symptoms awareness and to a reduction~     of heart rhythm disturbances in adults with or without structural heart disease. The~     principal endpoints will be a decrease in the total score of symptoms awareness.~   "
69876|NCT02652325|"~     To determine if routinely available 10% povidone-iodine swabs are more effective than saline~     and 3M Skin and Nasal Antiseptic 5% Povidone-Iodine USP for decolonizing MRSA.~   "
69877|NCT02652312|"~     The aim of this study is to calculate desflurane consumption when combined with~     intraoperative dexmedetomidine infusion guided by bispectral index (BIS)~   "
69902|NCT02651987|"~     This study aims to explore the efficacy and safety of lanreotide Autogel® 120 mg administered~     every 14 days in subjects with grade 1 or 2, metastatic or locally advanced, unresectable~     pancreatic or intestinal neuroendocrine tumours (NETs) once they have progressed on the~     standard dose of lanreotide Autogel® 120 mg every 28 days.~   "
69878|NCT02652299|"~     This study will focus on a rare cell population called fibrocytes in peripheral blood and~     synovial tissue in Rheumatoid Arthritis (RA). One group of patients with early RA and one~     group with long-standing RA. Both groups will be followed for 6 months.~      After informed and written consent a control groups is also formed: One for synovial biopsies~     for patients undergoing a routine arthroscopy, where a peripheral blood sample is also taken.~      The hypothesis is that fibrocytes are present in the blood and synovial tissue in RA.~     Patients with early and long-standing RA have higher concentrations of fibrocytes in~     peripheral blood and synovial tissue compared to a control groups. Levels of fibrocytes in~     peripheral blood and synovial tissue are correlated with RA disease activity measures and~     imaging findings.~   "
69879|NCT02652286|"~     Video-assisted thoracic surgery (VATS) anatomical lung resection provides an effective~     minimally invasive treatment strategy for stage I and II lung cancer. VATS lobectomy is~     associated with significantly less postoperative atrial fibrillation, blood transfusion,~     renal failure, and other complications when compared with lobectomy via thoracotomy.~      Although VATS lobectomy has been proven to be effective and safe in experienced hands, it is~     not devoid of risk. Intra-operative surgical complications can be at times catastrophic.~     Complications include: pulmonary vascular injuries (Pulmonary artery (PA), pulmonary vein)~     necessitating urgent conversion to open thoracotomy and even death. Causes of conversion~     included PA injury, difficult anatomy, bulky/calcified lymph nodes, and technical problems~     including stapler misfire. PA injury alone constituted 37.5% of all conversions. Proper~     dissection of all tissue around PA branches is sometime difficult especially in the presence~     of adhesions or large, calcified lymph nodes and may increase the risk of vascular injury.~      Currently, in spite of being a safe and effective technique in experienced hands, a minority~     of anatomical pulmonary resections are being performed by VATS. In an analysis utilizing the~     Nationwide Inpatient Sample (NIS) database in the United States, only 15% of anatomical lung~     resections were performed by VATS.~      The technical difficulty and danger of VATS lobectomy is directly related to PA branch~     manipulation, stapling and division. PA manipulation is the main hesitation of many thoracic~     surgeons regarding the adoption of VATS lobectomy. We believe that if we can decrease the~     manipulation and dissection required by the surgeon on the PA branches, we can make these~     procedures safe and therefore more prevalent for anatomical pulmonary resections.~   "
69880|NCT02652273|"~     The purpose of this study is to use abatacept as a clinical molecular probe to evaluate the~     effects of inhibiting costimulation on immune responses in patients with rheumatoid arthritis~     (RA).~   "
69881|NCT02652260|"~     This study aims to evaluate a switch from fixed dose combination (FDC) treatment with~     ATRIPLA^TM for 12 weeks prior to screening to FDC treatment with MK-1439A in~     virologically-suppressed, human immunodeficiency virus type 1 (HIV-1)-infected participants.~     The primary hypothesis is that switching from ATRIPLA^TM to MK-1439A results in a lower~     proportion of participants with at least one CNS toxicity of at least Grade 2 intensity at~     Week 12 than continuation of ATRIPLA^TM treatment.~   "
69882|NCT02652247|"~     To determine if the analysis of exhaled breath condensate correlates with the development &~     resolution of pneumonia.~   "
69883|NCT02652234|"~     This is an open-label, single-arm study to assess the safety, tolerability and~     pharmacokinetics of Endostar subcutaneous injection in Chinese advanced NSCLC patients.~   "
69884|NCT02652221|"~     A prospective, pilot study using acoustic radiation force imaging (ARFI) ultrasound (US) to~     quantify liver stiffness in children and young adults with chronic liver disease. ARFI~     results will be compared to the current clinical standard of Magnetic Resonance Elastography~     (MRE) and to liver biopsy when available.~   "
69885|NCT02652208|"~     The purpose of the study is to compare two different types of decision support materials for~     patients considering treatment for chest pain or chest discomfort from heart disease.~   "
69886|NCT02652195|"~     The proposed study will investigate the effects of intranasal oxytocin administration on~     neural activity associated with social and non-social motivation.~   "
69887|NCT02652182|"~     The aim of this study is to investigate whether or not short-term expose to air pollution is~     associated with in-hospital outcomes, such as mortality and morbidity.~   "
69888|NCT02652169|"~     Platelet rich fibrin (PRF) is a new therapy option for chronic wounds with yet unproven~     therapeutic efficacy. This randomised controlled trial aims to provide evidence of the~     efficacy of PRF as monotherapy as well as a growth promoting carrier matrix for antimicrobial~     compounds. The investigators therefore designed a four armed trial with three PRF arms which~     are compared to each other as well as to an active comparator. The treatment arms are as~     follows:~      Study arm 1: PRF with amikacin and teicoplanin Study arm 2: PRF with placebo (0.9% sodium~     chloride) Study arm 3: PRF with PHMB (polyhexanid) plus Macrogolol (Lavasorb®) Study arm 4:~     Acticoat 7® wound dressing as active control Patients with infected chronic wounds may be~     included in this trial. Infection shall be diagnosed by an experienced senior infectious~     diseases specialist. Patients with untreated peripheral vascular occlusive disease as defined~     by an ABI (ancle brachial index) of < 0,7 are excluded from the trial as are patients with an~     uncontrolled diabetes mellitus or patients who have not received sufficient treatment for a~     diabetic foot syndrome. Any underlying illness will be treated following standard of care. In~     case of chronic venous insufficiency four-layered compression bandages will be applied each~     visit if tolerated by the patient. Alternatively compression stockings (Class III) are~     permitted. This is mentioned as Disease specific treatment in the protocol.~      Patients will receive treatment for 56 days. After 28 and 56 days the wound surface will be~     compared to the baseline. Infection parameters (c-reactive protein and leucocyte count) will~     be measured weekly. Evaluation of systemic antimicrobial therapy will be performed at each~     visit. Systemic antimicrobial therapy is started at the discretion of a senior infectious~     diseases specialist.~   "
69903|NCT02651974|"~     This is a sub-study nested within a previously initiated clinical study (# NCT01946282)~     focusing on individuals not previously randomized at baseline to the original interventions.~     The purpose of the sub-study is to evaluate, via a randomized controlled trial design, 3~     strategies for promoting screening completion among individuals not up to date with~     colorectal cancer screening, but assigned to receive screening outreach.~   "
70050|NCT02650063|"~     The purposes of this study are to evaluate the safety and plasma pharmacokinetics of DE-117~     ophthalmic solution (one drop once daily for 7 days) in healthy male adults.~   "
69889|NCT02652156|"~     This clinical trial will examine differences in the effectiveness between three (3) commonly~     used methods and/or medications used to perform a transversus abdominis plane (TAP) block for~     post-operative pain control. The transversus abdominis muscle is either side between the~     lowest rib and the hip bone. Group A subjects will undergo post-operative pain relief~     treatment with a single injection of Bupivacaine injected into the TAP. Group B subjects will~     undergo post-operative pain relief treatment with a single injection of Exparel®, a liposomal~     form of bupivacaine into the TAP. Group C subjects will be treated with a continuous infusion~     of the local anesthetic ropivacaine with the ON-Q® pump. There will be no placebo group in~     this study.~   "
69890|NCT02652143|"~     This Clinical Study has been designed to assess and compare the impact of in vitro or in vivo~     culture conditions on the euploidy of sibling blastocysts.~   "
69891|NCT02652130|"~     Ongoing safety assessment follow up to Protocol MSB-GVHD 001 of remestemcel-L treatment in~     pediatric subjects with acute Graft versus Host Disease (aGVHD), following allogeneic~     hematopoietic stem cell transplant (HSCT), that have failed to respond to treatment with~     systemic corticosteroid therapy.~   "
69892|NCT02652117|"~     This retrospective review presents a comparison of pediatric patients less than 5 years old~     undergoing cardiac surgery with general anesthesia with spinal, caudal epidural, or caudal~     epidural with catheter anesthesia from July 2007 to July 2013 observing differences in time~     to extubation, reintubation, and hypercarbia.~   "
69893|NCT02652104|"~     This study reviews the outcome of deep brain stimulation treated patients in Helsinki and~     Uusimaa University Hospital between 2006 and 2014. The aim of the study is to investigate the~     outcome and possible side effects of deep brain stimulation treatment.~   "
69894|NCT02652091|"~     The primary objective of this study is to assess adherence and persistence to BETASERON~     therapy in patients who are using the BETACONNECT auto-injector device (BETACONNECT device).~      The secondary objective of this study is to assess patient-reported satisfaction with the~     BETACONNECT device.~   "
69895|NCT02652078|"~     Peripheral arterial disease is a common condition affecting approximately 64% of 56-77 year~     olds. This condition restricts bloody supply to calf muscles. Pain occurs after walking a~     short distance and increases in intensity until the person stops, where the pain then~     gradually subsides. It can be limiting or occasionally debilitating and has been shown to~     have considerable deleterious effects of patients quality of life. Shock wave therapy has~     been shown to promote new blood vessel formation and improved healing amongst other findings.~     This study aims to identify whether shock wave therapy that is applied to the calf muscles~     causes such an effect to improve the blood supply to the calf muscles, reduce pain, improve~     walking ability and quality of life.~   "
69896|NCT02652065|"~     Psoriasis is a chronic inflammatory cutaneous disease, affecting 3% of the French population.~     Among psoriatic patients, 80% feel pain or cutaneous discomfort related to their pathology.~      Neurogenic inflammation's role in psoriasis has recently been put forward by a study showing~     that TRPV1 ion channels are necessary to establish psoriasiform inflammation in mice.~      The investigators hypothesize that there is a link between cutaneous sensory neuropathies and~     altered cutaneous microcirculation during psoriasis.~      In order to test this hypothesis, local vasodilators will be delivered to patients by~     iontophoresis and their skin blood flow in response to these molecules will be followed by~     laser Doppler recordings. Two recordings will be performed for each patient, both on a~     psoriasis plaque and on uninvolved skin, in order for the patient to be his own internal~     control.~   "
69897|NCT02652052|"~     The investigators hope to find the proof of principle concept from this pilot study so that~     the investigators can design a clinical trial based on the results of the explanatory~     hypothesis.~   "
69898|NCT02652039|"~     The purposes of this study were 1) to delineate any differences in general musical taste~     (trait) and context-specific music preference (state), as well as preferred music~     characteristics in cancer patients, 2) to investigate the contributions of individual~     variabilities, personality, behavioral coping styles, and pain levels in predicting changes~     from trait to state preferences and preferred music characteristics under various pain~     conditions.~      Cancer patients were recruited to fill in questionnaires pertaining to their demographic~     information (age, gender, religious preference, ethnicity, music background and experience),~     personality traits, music preferences, preferences for music characteristics, coping styles,~     and pain experiences.~   "
69899|NCT02652026|"~     The main objective is to evaluate the effect of nonsurgical periodontal treatment on serum~     levels of HbA1c in patients with type 2 diabetes mellitus (T2DM). This study is a 6-month,~     single-masked, randomized clinical trial.A total of 90 patients with diabetes and chronic~     generalized periodontal disease will be randomly divided into 2 groups: Treatment Group,~     Control Group.~   "
69900|NCT02652013|"~     Multiple sclerosis (MS) progressively leads to an increasing level of disability. That's why~     individuals faced with this chronic disease whose progression is unpredictable have to~     mobilize all their available resources. As a result, management of interpersonal~     relationships appears to be a key issue in adjustment to situations.~      Although knowledge on cognitive abnormalities in MS has been growing in recent years, there~     is a lack of research about social behaviour regulation skills. The few studies conducted in~     this field are mainly interested in emotional processing (emotional facial recognition and~     empathy) and skills mentalizing (theory of mind) that appear disturbed in MS.~      While some recent studies touch on the issue of the contextual analysis of language (that is~     to say, the social use of language) in MS, their assessment on a wide range of pragamtic~     skills has never been studied. However, the pragmatic aspects of language are known to play a~     major role in social adjustment.~      This project has three main objectives : (1) to increase general knowledge of deficits in~     communication and in social cognition in patients with MS, (2) to propose new leads for the~     evaluation of these disorders and (3) to contribute to increasing knowledge of neural basis~     of communication and social cognition.~      In order to address those objectives, the assessment will be focused on many various~     pragmatics skills : conversation, indirect language comprehension (indirect questions,~     idiomatic expressions, sarcasm) and metapragmatic knowledge in a population of 40 RR-MS~     patients. Those patients' performances will be compared to a group of healthy matched control~     subjects, potential relationships between pragmatic abilities, other aspects of social~     cognition (theory of mind and processing of emotional stimuli), cognitive functioning,~     psycho-behavioural aspects and the characteristics of the disease will be explore.~      Social cognition tasks have been selected for their dynamic and ecologic aspects in order to~     match natural social interaction.~      Finally, communication consideration, cognitive and cerebral skills of patients with MS will~     contribute to increasing knowledge of the neural basis of social cognition.~   "
69901|NCT02652000|"~     Retrospective study to analyze Quality of life in men after iodine seed brachytherapy for~     localized prostate cancer~   "
70084|NCT02649608|"~     To evaluate the safety, tolerability, pharmacokinetics, and efficacy of the Lu AE04621 and~     metabolite after ascending oral doses of Lu AE04621 in patients with Parkinson`s Disease.~   "
69904|NCT02651961|"~     Chronic infection after total joint arthroplasty generally requires implant exchange. Two~     stage exchange is considered as the gold standard procedure. However, some authors suggest~     that one stage exchange may be as effective. No consensus exists in the current literature.~     The purpose of the study was to evaluate the cost of both strategies in comparison to their~     success rate.~   "
69905|NCT02651948|"~     Primary purpose:~      Complications and rehospitalizations after transperineal prostate biopsy MRI-guided are~     reduced than transrectal prostate biopsies.~      Secondary purposes:~        -  Patients tolerance after transperineal prostate biopsy MRI-guided is better than after~          transrectal prostate biopsies.~        -  Core of transperineal prostate biopsies are better than core of transrectal prostate~          biopsies~        -  Study of correlation between radiologic images and anatomopathologic result~        -  Description of needle track during the procedure~        -  Description of real time template saturation prostate biopsy~        -  Comparison of transperineal prostate biopsy relevance according to EBM~        -  Comparison of 1.5T MRI and 3T MRI for prostate cancer detection~   "
69906|NCT02651935|"~     This study will evaluate the effect of a fully closed loop ventilation mode (Intellivent ASV)~     on the duration of ventilation compared to conventional modes in COPD patients.~   "
69907|NCT02651922|"~     The study was carried out as a prospective, non-interventional study with the intention of~     subsequent process cost analyses (PCA) and also considers quality of life, drug misuse,~     dependence, adverse events and therapy satisfaction.~   "
69908|NCT02651909|"~     The invesigators seek to devise a strategy for the assessment of Rivaroxaban activity in~     trauma and Emergency General Surgery (EGS) patients available as point-of-care testing.~      Thromboelastography (TEG) is a point of care, viscoelastic measurement of coagulation that is~     widely used in trauma and is viewed by many as superior to standard coagulation studies for~     the assessment of coagulopathy following injury and may be useful in detecting rivaroxaban~     effect in trauma and EGS patients to assess the degree of functional factor Xa impairment.~   "
69909|NCT02651896|"~     Hypofractionated intensity modulated and image guided radiotherapy (HypoIGRT) with fewer~     high-fraction-size treatments would be beneficial for prostate cancer because it would~     deliver a larger biological-equivalent dose to the tumor than would conventional treatment in~     1.8-2.0 Gy fractions, while maintaining a similar or lower incidence of late normal tissue~     reactions. Thus, the investigators aim to assess the hypothesis that HypoIGRT treatment for~     localized prostate cancer will improve the therapeutic ratio by either:~        1. Reducing normal tissue, mainly genitourinary and gastrointestinal, toxicity and / or~        2. Improving tumour control, mainly freedom from biochemical failure survival.~   "
69910|NCT02651883|"~     This study will investigate whether cervical cancer screening completion among under-screened~     women could be improved by offering HPV (human papillomavirus) testing by at-home~     self-collection followed by screening invitation compared to screening invitation alone.~   "
69911|NCT02651870|"~     A Phase 3 Trial to Evaluate the Efficacy and Safety of a Combination Therapy of Candesartan~     and Amlodipine Versus Candesartan Monotherapy in Hypertensive Patients Inadequately~     Controlled by Candesartan Monotherapy~   "
69912|NCT02651857|"~     Single-Center, Exploratory Study of EndoChoice's Upper and Lower Gastrointestinal Endoscopic~     Systems Utilizing EndoChoice's Full Spectrum Optical Technology~   "
69913|NCT02651844|"~     -  Seventy per cent of breast cancers express estrogen (ER) and progesterone receptors (PR)~          and respond to endocrine treatment.~        -  Actual therapy targets ER.~        -  There is enough evidence that progestins participate regulating breast cancer growth.~        -  Antiprogestins block cell proliferation and increase apoptosis in breast cancer models~          which express high levels of PRA.~        -  Antiprogestins have been used to treat breast cancer patients that failed to other~          treatments; benefits were seen in selected patients.~        -  Mifepristone (MFP) is currently used for medical abortion and for the treatment of~          Cushing disease.~        -  MFP might exert agonistic effects when PRB isoform is activated by cAMP. This makes~          mandatory the evaluation of the PR isoform ratio in breast cancer patients in which MFP~          is a therapeutic possibility.~      Main Goal To evaluate if therapeutic doses of MFP exert beneficial effects on breast cancers~     expressing levels of PRA higher than those of PRB, evaluated as an inhibition in~     proliferation markers and/or an increase in apoptotic markers.~        -  Eligibility~             -  Postmenopausal women (one year after menses stop).~             -  Women with tumors showing ratios of PRA/PRB higher than 1.5 and PR higher than 50%.~             -  Women without previous treatment.~             -  All clinical stages with tumors larger than 1.5 cm.~             -  Patients without autoimmune diseases and/or asthma.~        -  Study design~             -  Open Interventional.~             -  Twenty women will take MFP (200 mg) p.o. once /day during 14 days. As for~               preliminary studies, to reach this number the investigators will have to evaluate~               80-100 patients.~             -  Surgery is performed 14 days after treatment initiation, 24 hs after last dose.~             -  PR isoform ratio will be evaluated by western blots (WB) in one core biopsy.~               Additional cores will be used for diagnosis, immunohistochemistry (IHC) of PR,~               Ki-67 and other markers.~             -  At surgery samples will be frozen for molecular studies and fixed and processed for~               pathological evaluation.~             -  Wilcoxon signed rank test will be used to evaluate differences in biomarker~               expression between core biopsy and surgical samples of each patient.~             -  Blood will be collected before treatment initiation and prior to final surgery.~             -  Mammographic and echographic studies will be carried out before and after~               treatment.~   "
69914|NCT02651831|"~     This study aims to develop a health related quality of life (HRQOL) patient reported outcome~     (PRO) for patients receiving immune checkpoint modulator (ICM) therapy. This instrument could~     be used to in clinical trials to evaluate HRQOL for patients treated with novel ICMs and ICM~     combinations that might ultimately influence decisions about regulatory approval, as well as~     improved understanding of chronic treatment effects on patient well-being, understanding~     reasons for treatment non-adherence, and developing strategies to improve adherence and~     evaluating clinical outcomes.~   "
69915|NCT02651818|"~     The aim is to investigate the influence of surgical treatment on benign non-toxic goiter on~     the disease specific quality of life evaluated 6 months after thyroid surgery.~      All investigations follow already scheduled treatments.~   "
69929|NCT02651636|"~     The aim of our study is to investigate the effects of a combined treatment of alpha-lipoic~     acid and myoinositol on clinical, endocrine and metabolic features of women affected by PCOS.~     The study Group included 40 patients treated with a combined therapy of alpha-lipoic acid~     (800 mg), myoinositol (2000 mg) and folic acid (400 mcg) daily for six months. The~     investigation includes menstrual pattern, hirsutism score, hormonal assays, oral glucose~     tolerance test, lipidic profile at baseline and after six months of treatment.~   "
69930|NCT02651623|"~     The purpose of this study is to demonstrate a lack of effect of sertraline on QTc intervals~     relative to time-matched placebo in healthy subjects~   "
69931|NCT02651610|"~     The primary purpose of this research study is to see whether adding bavituximab (an~     investigational drug) to the standard chemotherapy drug taxane, will improve the results of~     the treatment for HER2-negative metastatic breast cancer.~   "
69932|NCT02651597|"~     The objectives are to assess the effects of high viscosity vs. medium and low viscosity oat~     β-glucan on post-prandial glycemic response in healthy adult participants.~   "
69916|NCT02651805|"~     Patients with advanced chronic diseases may suffer with respiratory secretion and available~     therapies to control this condition are uncomfortable or little effective in palliative care~     patients. Therefore, alternative therapies should be tested, assessing clinically relevant~     outcomes in palliative care, such as comfort during therapy and the number of interventions~     required in a day. Mechanical Insufflation-Exsufflation is an option that presents~     advantages, since it can be used in patients with minimum cooperation and is non-invasive,~     which may lead to higher comfort during therapy.~      The aim of the study is to verify the feasibility of a clinical trial comparing the effects~     of Mechanical Insufflation-Exsufflation with usual care in hospitalized palliative care~     patients that are suffering with respiratory secretion. Patients allocation will follow a~     fast-track allocation design, in which included patients will be randomized in two groups:~        1. Receive Mechanical Insufflation-Exsufflation therapy in the moment that is assigned to~          this group;~        2. will receive 24h of usual care and after that will be allowed to choose between usual~          care or Mechanical Insufflation-Exsufflation Therapy.~      The assessments will be: Time from the first intervention until the need of a following~     intervention, discomfort due therapy, discomfort due respiratory secretion, palliative~     outcome scale, number of adverse events and number of interventions during 24h period. The~     primary outcome is to verify the feasibility of developing a future larger clinical trial to~     assess the effects of the use of Mechanical Insufflation-Exsufflation to control respiratory~     secretions in patients in palliative care.~   "
69917|NCT02651792|"~     The investigators aim to investigate the differences between ketamine propofol and pethidine~     propofol during ERCP in respect to endoscopist satisfaction.~   "
69918|NCT02651779|"~     There is no consensus about the best treatment for patients with displaced complete articular~     distal radius fractures (AO type C fractures). Despite this lack of consensus and the lack of~     available literature on comparative data to guide treatment for this patient population,~     operative treatment with plate fixation has gained popularity. The aim of this study is to~     compare the functional outcome of open reduction and plate fixation with closed reduction and~     plaster immobilisation in adult patients (18-75 years) with displaced complete articular~     distal radius fractures.~   "
69919|NCT02651766|"~     The study aims to investigate the influence of 5 cupping massage treatments on chronic non~     specific neck pain. 50 patients with neck pain are randomised into cupping treatment and~     waiting list control group. Before and after the intervention the investigators evaluate the~     neck pain (VAS), the neck related disability (NDI), pain on movement (POM) and the quality of~     life (SF36) and safety. To investigate neurophysiological effects of cupping the~     investigators also measure mechanical detection threshold (MDT), vibration detection~     threshold (VDT) and pressure pain threshold (PPT) and the two point discrimination threshold~     at pain related and control areas.~      The treatment group receives 5 cupping treatments over a period of 3 weeks.~   "
69920|NCT02651753|"~     This study is a randomized, open-label, single oral dose, 2-way crossover clinical trial to~     compare safety and pharmacokinetics of CKD-337 in healthy male volunteers.~   "
69921|NCT02651740|"~     The purpose of this study is to evaluate the efficacy as well as safety of rifaximin combined~     fecal microbiota transplantation(Gut microbiota reconstruction) in the treatment of IBS-D.~   "
69922|NCT02651727|"~     The purpose of this study is to evaluate increasing dose levels of VS-4718 administered in~     combination with gemcitabine and nab-paclitaxel in subjects with advanced cancer and to~     determine a recommended Phase 2 dose (RP2D) for further development of this combination in~     subjects with untreated advanced pancreatic cancer.~   "
69923|NCT02651714|"~     This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in~     the United States in subjects with treatment-resistant pruritus diagnosed with atopic~     dermatitis.~   "
69924|NCT02651701|"~     The purpose of this study is to measure the diagnostic performance of whole body (WB) MR-PET~     for staging rectal cancer, compared with current standard of care (chest/abdominopelvic CT~     and rectal MRI) to investigate clinical feasibility of WB MR-PET as a one-stop preoperative~     imaging modality in patients with rectal cancer.~   "
69925|NCT02651688|"~     The purpose of this study is to compare the effects of 12 months of treatment with~     enclomiphene 12.5 mg, 25 mg, or placebo capsules on body composition and metabolic parameters~     in overweight men with acquired hypogonadotropic hypogonadism (confirmed morning T≤300 ng/dL)~     following a 6 month diet and 15 month exercise program.~   "
69926|NCT02651675|"~     Homozygous Familial Hypercholesterolemia (HoFH) is a rare genetic metabolic disorder~     characterized by absent or severely reduced capacity to catabolize circulating LDL particles~     by the hepatic LDL receptor. As a consequence, HoFH subjects present abnormal total plasma~     cholesterol (LDL-C) levels, resulting in severe atherosclerosis often leading to early onset~     of cardiovascular disease. Early initiation of aggressive treatment for these patients is~     therefore essential. Unfortunately, despite existing therapies, treated LDL-C levels could~     remain well above acceptable levels. Thus, the functional replacement of the defective LDLR~     via AAV-based liver-directed gene therapy may be a viable approach to treat this disease and~     improve response to current lipid-lowering treatments. This first-in-humans study is intended~     to evaluate the safety of this gene therapy investigational product and assess preliminary~     evidence of efficacy using plasma LDL-C levels as a surrogate biomarker for human LDLR~     transgene expression.~   "
69927|NCT02651662|"~     This is an open-label, multicenter, dose escalation study of REGN2810 and REGN1979 in~     patients with lymphoma. The study treatment period will be from 6 to 12 months, depending on~     how an individual patient responds to treatment. The follow-up period will be 6 months for~     all patients.~   "
69928|NCT02651649|"~     Sleep disordered breathing (SDB) during pregnancy is a modifiable risk factor for poor~     maternal and fetal outcomes. The investigators propose a prospective observational study to~     assess the utility of continuous positive airway pressure (CPAP) administration~     (intervention) during pregnancy to reduce maternal and fetal morbidity. Secondarily, we will~     also perform a cohort study to assess the incidence of antenatal sleep-disordered breathing~     as measured by ambulatory sleep monitoring applied in the hospital setting.~   "
69933|NCT02651584|"~     Phase III, randomized, double-blind, double-dummy, active-controlled, parallel group~     multi-center trial, designed to evaluate the non-inferiority of CAM2038 compared to an~     existing standard of care (SL BPN) in initiation and maintenance treatment with BPN.~   "
69934|NCT02651571|"~     The total knee replacement has become a routine procedure. Survival rate of over 90% after 10~     years are generally reported. However, complications and reoperation may still occur for many~     reasons, and some of them may be related to component design: loosening (tibial above),~     polyethylene wear, knee stiffness, ligamentous instability, etc ... . Therefore, new designs~     can, at least in theory, improve the results of conventional models.~      In this study, the investigators want to compare retrospectively data concerning survival~     rates of patients wearing total knee prosthesis with mobile plate for over 10 years, with the~     ones published in the literature for conventional fixed-bearing prostheses.~   "
69935|NCT02651558|"~     Comparison of an optical method to continuously measure blood pressure against an invasive~     arterial catheter.~   "
69936|NCT02651545|"~     Cognitive impairment is common in MS and has devastating impact on functional activities.~     There is a great demand for medications that will enhance cognitive capacity in MS patients.~     The effect of teriflunomide on cognition and vocational capacity is unknown. The~     investigators will address these questions in a sample of 30 relapsing MS patients treated~     with teriflunomide. Cognitive impairment will be measured by calculating an information~     processing speed index and a memory composite index from conventional, validated~     neuropsychological tests as recommended by consensus opinion publications. Vocational~     performance will be monitored using a newly developed online survey called the Multiple~     Sclerosis Vocational Monitoring Survey (MSVMS). This study will elucidate the effect of~     teriflunomide on these important outcomes.~   "
69937|NCT02651532|"~     Irritable bowel syndrome (IBS) is one of the most common gastrointestinal disorders. It has~     prevalence in general population of 5-20% and is more common in women and young adults.~      Despite being one of the most frequent reasons for consultation many patients are~     undiagnosed. There are no reliable biomarkers. The diagnosis is clinical, based on the Rome~     III criteria. IBS is characterized by chronic or recurrent abdominal pain associated with~     changes in bowel frequency and consistency, when other etiologies are excluded. The~     combination of the Rome III criteria with the absence of alarm symptoms have a sensitivity of~     65%, specificity of 100%, 100% positive predictive value and negative predictive value of~     76%.~      Current tests commonly fail to obtain an objective diagnosis, and effective therapies are~     lacking. There are no specific endoscopic findings that can discriminate IBS patients from~     healthy patients. Most colonoscopies are performed to rule out other etiologies and in more~     than 50% of the cases are normal.~   "
69938|NCT02651519|"~     Stellate-ganglion block have been done safely for more than 60 years. It has proved to~     provide survivors of breast cancer with relief from hot flushes and sleep dysfunction with~     few or no side-effects. The aim of the present study is to evaluate postoperative sleep~     quality of patients undergoing breast cancer surgery with Stellate-ganglion block performed~     in the operation.~   "
69939|NCT02651506|"~     The use of computed tomography (CT) screening has allowed for early detection of lung cancers~     as small as 5mm in diameter. Early stage cancers are highly curable with a reported survival~     of greater than 90% over 5 years after surgical resection. Before a patient can have surgery,~     a biopsy must be performed. One common method is a transthoracic needle biopsy (TTNB). In~     this procedure, a CT-image is used to locate the area for biopsy. Once identified, the~     radiologist applies a local anesthetic and inserts an aspiration needle through the ribs, and~     into the lung tissue. The sampled lung tissue is then sent to pathology. Although this~     procedure has a diagnostic yield ranging between 70% and 85%, it is associated with serious~     complications such as pneumothorax, hemoptysis, infection, hemothorax, air embolism and there~     is about a 20% (range 9%-54%) incidence of pneumothorax, or air leak from the lung, requiring~     chest tube drainage. Additionally, about 5-15% of cases experience hemoptysis, or coughing~     blood, although significant life-threatening hemoptysis is only present in less than 1% of~     patients. When these complications occur, hospitalization as inpatients is required, with an~     average length of stay of 1-3 days.~      A new form of technology to localize and biopsy peripheral lung lesions is believed to~     significantly reduce the amount of complications that can occur during a biopsy. This~     technology is known as Electromagnetic Navigation Bronchoscopy (ENB). ENB uses~     electromagnetic tracking and CT-generated virtual bronchoscopy to create a three-dimensional~     GPS map of the lung, guiding the surgeon directly to the tumor. The surgeon is then able to~     perform bronchoscopy and biopsy the tumor from inside the bronchus. A recent systematic~     review and meta-analysis of 15 trials reports a pneumothorax rate of 3.1%, with only 1.6% of~     patients requiring chest tube drainage. Initial studies demonstrate a slightly lower~     diagnostic yield for ENB as compared to TTNB; however, a systematic exploration of study~     heterogeneity reveal that lung nodules included in TTNB studies are larger than those~     included in the meta-analysis of ENB yield. The review further identified six variables~     associated with increased diagnostic yields for ENB, including combined use of an ultrasonic~     radial probe and catheter suctioning as a sampling technique. The superDimension® InReach™~     System was granted Health Canada approval on July 23, 2009.~      There have been no studies directly comparing ENB to TTNB, either retrospectively or~     prospectively. Initial systematic reviews demonstrate that ENB may have a slightly lower~     diagnostic yield relative to TTNB. Selection bias and low study quality may have resulted in~     an underestimation of the true diagnostic yield associated with ENB. The literature also~     confirms that ENB has a significantly better safety profile as compared to TTNB. As such, a~     prospective comparison between the two techniques is mandated. This Phase II pilot~     feasibility trial will utilize randomized methodology to gather the preliminary data that is~     required for the successful completion of a Phase III randomized controlled trial to compare~     lung biopsy with ENB verses TTNB. This study will also be the first time ENB lung biopsy is~     documented in Canada.~   "
69940|NCT02651493|"~     In this study, the investigators propose a novel method to detect Down syndrome using~     photography for facial dysmorphology, a tool called computer-aided diagnosis (CAD). After~     validating the method, this technology will be expanded to perform similar functions to~     assist in the detection of other dysmorphic syndromes.~      By using photography and image analysis this automated assessment tool would have the~     potential to improve the diagnosis rate and allow for remote, non-invasive diagnostic~     evaluation for dysmorphologists in a timely manner.~   "
69941|NCT02651480|"~     The proposed study seeks to test the effect of a plant-based dietary intervention on~     cardiovascular risk factors in police officers.~   "
69942|NCT02651467|"~     This will be a single center, eight week, randomized, double blind, three treatment arm,~     parallel design, stratified (by mean baseline Schiff Sensitivity Score of the two selected~     test teeth) study in healthy participants.~   "
69943|NCT02651454|"~     The Purpose of this trial is to investigate the efficacy and safety of Daesiho-tang and~     Taeeumjowi-tang on Korean obese Women with metabolic syndrome Risk factors~   "
69944|NCT02651441|"~     The purpose of this study is to evaluate the safety and efficacy of chemotherapy combined~     with dendritic activated cytokine-induced killer cell (D-CIK) for non-small cell lung cancer~     (NSCLC).~   "
69945|NCT02651428|"~     The purpose of this study is determine safety and effectiveness of Neutrolin, a catheter lock~     solution, for prevention of central venous catheter associated bloodstream infection in~     hemodialysis patients.~   "
69946|NCT02651415|"~     The purpose of this study is to find out what effects the combination of regorafenib and~     perindopril has on hand-foot skin reaction (HFSR), on high blood pressure (hypertension) and~     on any other types of side-effects and compare it to the published incidence of the~     side-effects with regorafenib alone.~      This research is being done in an attempt to reduce the side-effects associated with~     regorafenib.~   "
69947|NCT02651402|"~     Unresolved psychological problems, such as anxiety, affect a significant number of our~     students and interfere with their ability to attend, actively participate, and prosper in~     school. This project will expand the capacity of selected mental health agencies to provide~     services in the participating schools through school therapeutic services (STS). The project~     will provide enhanced training in evidence-based behavioral health interventions to~     school-based mental health providers. The services will be implemented by STS Bachelor's or~     Master's level therapists supervised by their mental health agency supervisors (Internal~     Support), who are in turn supported by the research team (Train-the-Trainer) or external~     consultants (Train the Trainer+).~   "
69948|NCT02651389|"~     This clinical trials aims to evaluate Tests Performance on a New Digital Orthoptic Platform.~   "
69949|NCT02651376|"~     Combined antiretroviral therapy (cART) efficiently suppress viral replication in majority of~     AIDS patients. The morbidity and mortality of the disease has dramatically decreased over the~     past 20 years. However, chronic human immunodeficiency virus-1 (HIV-1) infection lead to~     profound immune defects in some advanced AIDS patients who often develop with severe~     opportunistic infections (OIs), severe cachexia and other deadly complications, which~     accounts for the major death group even under cART. Up-to-date, there are no effective immune~     interventions to restore host holistic immunity for advanced AIDS patients.~   "
69950|NCT02651363|"~     The purpose of this study is to collect adverse events and identify risk factors in patients~     that are taking Dolocordralan Extra 25® and Dolocordralan Extra Forte®~   "
69952|NCT02651337|"~     The objective of this pilot study is to perform a set of pressure and flow rate measurements~     in order to quantitatively characterize safe irrigation or flushing of a ventricular shunt~     catheter, a routine maneuver performed by a neurosurgeon during a shunt revision surgery.~     This maneuver involves injecting saline with a syringe to clear plugged shunt catheters.~     Based on data obtained in Stage I of the study, a device has been fabricated which provides~     the same small-volume pulse of fluid used by surgeons. In Stage II of the study, pressure and~     flow rate measurements generated by this specialized flusher device will be collected and~     measured.~   "
69953|NCT02651324|"~     This study hypothesizes that the addition of a low-dose ketamine infusion to usual~     post-operative pain management will improve pain control as evidenced by an improvement in~     post-operative pain scores for patients undergoing spinal fusion for idiopathic scoliosis.~   "
69954|NCT02651311|"~     Congenital Muscular Torticollis (CMT) is a postural deformity of head and neck detected at~     birth or shortly after birth, primarily resulting from unilateral shortening of~     Sternocleidomastoid Muscle (SCM). Surgery could be chosen for the treatment for some~     children, which is accompanied by moderate pain and discomfort. The investigators focused the~     effectiveness of intermediates cervical plexus block because the dermatome of sensory of~     cervical plexus block is correlated to that of torticollis. So the effect of analgesia could~     decrease the use of analgesics.~   "
69955|NCT02651298|"~     Fractional Co2-laser for treatment of mature caesarean section scars.~   "
69956|NCT02651285|"~     The purpose of this study is to determine whether in Assisted Reproductive Technologies the~     use of culture medium supplemented with G-CSF, a growth factor working on stem cells, may~     improve the embryo implantation and pregnancy rate in infertile patients undergoing IVF~     cycles.~   "
69957|NCT02651272|"~     This is a pilot study to assess the safety and efficacy of macitentan in patients with~     pulmonary hypertension of sickle cell disease. This study will enroll approximately 10~     subjects. Study participation for each subject will last approximately 24 weeks from~     screening to end of treatment follow-up.~   "
69958|NCT02651259|"~     The purpose of this study is to evaluate the pharmacokinetics, tolerability, and safety of~     once-weekly doses of rifapentine (RPT) and isoniazid (INH) in HIV-1-infected and~     HIV-1-uninfected pregnant and postpartum women with latent tuberculosis (TB).~   "
69959|NCT02651246|"~     The primary goal of this optional sub-study is to record what tissues fluoresce in the~     operating room, and then to identify if these lesions are cancer when the histopathology is~     performed.~   "
69960|NCT02651233|"~     Human adipose tissue has been shown to contain a group of cells that possess extensive~     proliferative capacity and the ability to differentiate into multiple cell lineages. Cells~     isolated from the fatty portion are termed processed lipoaspirate cells that contain~     adipose-derived regenerative cells (ADRCs). ADRCs are most conveniently extracted from tissue~     during an elective cosmetic liposuction procedure but may also be obtained from resected~     adipose tissue.~      This study is aimed to verify if there are differences between the number and viability of~     cells obtained from patients with different age, sex, Body Mass Index (BMI), smoking and~     physical activity, within the different amount of processed fat.~   "
69961|NCT02651220|"~     A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study~     to Evaluate the Therapeutic Equivalence and Safety of adapalene and benzoyl peroxide gel,~     0.3%/2.5% (Actavis Laboratories UT, Inc.) to Epiduo® Forte (adapalene and benzoyl peroxide)~     gel 0.3%/2.5% (Galderma) in the treatment of Acne Vulgaris~   "
69962|NCT02651207|"~     Study to look at the acceptability of local anaesthetic spray versus injection, prior to~     contraceptive implant insertion~   "
69963|NCT02651194|"~     The purpose of this study is to assess the efficacy and safety of 12 weeks of treatment with~     the ABT-493/ABT-530 combination regimen in adults with chronic HCV genotype 1 - 6 infection~     and chronic severe renal impairment.~   "
69964|NCT02651181|"~     Closed loop technology has been shown to reduce both hypoglycemia and hyperglycemia, as well~     as reduce glycemic variability.~      Several groups around the world investigate efforts in developing closed-loop systems.~     Investigators combined two closed-loop systems with different mode of operation in order to~     enhance the closed-loop system. The two systems are Hybrid closed-loop system and the~     MD-Logic closed-loop system . The combined algorithm Hybrid logic closed loop (HLCL) was~     tested 'In silico' and was proved to be safe and effective. The next step is to test the~     system in a clinical study in a supervised environment in a camp.~      The two systems were tested separately in several clinical studies and were proven to be safe~     and effective in a diverse population of patients with type 1 diabetes. The MD-Logic system~     for overnight use the GlucoSitter has a CE mark.~      The purpose of this study is to collect data on the feasibility of the HLCL system in a camp~     setting.~   "
69965|NCT02651168|"~     Diabetic macular edema refers to swelling (fluid accumulation) in the center of the retina.~     The retina is like the film of a camera and is located in the back of the eye. This condition~     can develop in diabetics where swelling results from leaking of fluid from the blood vessels~     of the eye, into the center of the retina, the macula. If left untreated, this can affect~     central.~      The current standard treatment for diabetic macular edema includes medications injected~     directly into the eye (intravitreal injections) and laser eye treatment. The drugs that are~     injected directly into the eye are known as anti-VEGF agents which help to reduce the~     leaking. This includes bevacizumab (Avastin®) and ranibizumab (Lucentis®).~      However, some patients do not respond well to these anti-VEGF treatments and will be given~     the option of switching to an another newer anti-VEGF medication, called aflibercept (Eylea®)~     that is approved to treat DME. A recent large study has demonstrated that aflibercept was as~     efficacious as other anti-VEGF therapies listed above and was even superior in patients with~     worse vision (Diabetic Retinopathy Clinical Research Network, Wells JA, Glassman AR, et al.~     Aflibercept, Bevacizumab, or Ranibizumab for Diabetic Macular Edema. N Engl J Med.~     2015:150218140025008-150218140025008).~      The purpose of this study is to determine what factors affect the treatment response to~     aflibercept (amount of swelling reduction) for patients with diabetic macular edema, who were~     previously unresponsive to ranibizumab injections.~   "
69966|NCT02651155|"~     The purpose of this study is to evaluate the efficacy and safety of oral administration of~     lubiprostone 24 μg twice daily (BID) for 4 weeks in participants with chronic idiopathic~     constipation (CIC) compared with placebo.~   "
69967|NCT02651142|"~     Sentinel lymph node biopsy（SLNB） is an established way of predicting axillary nodal~     metastasis in early breast cancer. We aim to determinethe，in a prospective randomized,~     controlled trial, effect of sentinel lymph node biopsy with para-sentinel lymph node(SLN)~     dissection versus sentinel lymph node biopsy without para-sentinel lymph node dissection on~     outcomes after breast surgery.~   "
69968|NCT02651129|"~     The effect of noise is often underestimated but it is one of the most common occupational~     health hazards. Its health effects include; noise-induced hearing loss, sleep disturbance,~     interference with speech comprehension, complaints, stress, annoyance, and safety concerns~     with regard to workers being able to complete their tasks in a safe manner.~      This pilot aims to measure and analyze noise levels in obstetric ORs at BC Women's Hospital~     during elective and emergency cesarean deliveries.~   "
69969|NCT02651116|"~     This is a placebo-controlled, double-blind, randomized, parallel group pilot study in~     approximately 150 subjects to evaluate the efficacy of dextromethorphan hydrobromide (DXM) on~     acute cough in a pediatric population. Subjects will be otherwise healthy males and females~     aged 6-11 inclusive who are experiencing acute cough as a symptom of common cold or upper~     respiratory tract infection. Subjects must have had onset of symptoms within 3 days of~     screening and qualify based on physical exam and symptom questionnaire. Eligible subjects~     will be given a single-blind placebo, and fitted with a cough counting device for a 2 hour~     run-in period. Qualifying subjects will be stratified by age and then randomized to either~     DXM or placebo in a 1:1 ratio and fitted with the cough recording device for the first 24~     hours of treatment. Subjects will receive approximately 9 doses of investigational product~     over the course of the 4 day study and will complete patient reported outcome questions~     before the morning and afternoon doses. Subjects will return to the study site on Day 2 to~     remove the cough recorder and on Day 4 (+ 2 days) to complete the final visit. A review of~     any reported adverse events will also be completed.~   "
69970|NCT02651103|"~     The proposed research aims to investigate how different ventilation strategies may affect~     cerebral tissue oxygenation in the pediatric population. It will contribute to the literature~     exploring the NIRS monitoring device which is becoming increasingly utilized in a variety of~     anesthetic and critical care settings. It may help to guide clinical practice regarding~     optimal ventilation strategies, and how ventilation may be altered to correct suboptimal~     cerebral tissue oxygenation.~      This prospective study will include 50 patients undergoing posterior spinal fusion that~     requires placement of an arterial cannulation. There will be no change in the anesthetic or~     perioperative care of these patients. Tissue and cerebral oxygenation will be monitored using~     near infrared spectroscopy (NIRS).~   "
69971|NCT02651090|"~     Patients with renal failure or other reason for contraindication for contrast enhanced~     computed tomography (CECT) or contrast enhanced magnetic resonance imaging (CEMRI) with~     suspected liver pathology will be evaluated with Sonazoid enhanced Ultrasound~   "
69972|NCT02651077|"~     The investigators wish to highlight, in a Case-Control design, if there is an increased~     concentration of BFRs in omental adipose tissue of cases ( women with severe endometriosis~     with surgical indication ) versus bioaccumulation recorded in a control cohort ( women~     recruited in obstetrics and gynecology or visceral surgery showing no sign of endometriosis )~     . Pairing will be operate on Age (+/- 5 years compared to the case ) , BMI ( BMI 5 Classes~     described by the HAS) and previous breastfeeding experience (yes / no , opposite the release~     expected bioaccumulate contaminants in breast adipose tissue , when the lactation ) .~   "
69973|NCT02651064|"~     The USDA Healthy Incentives Pilot (HIP) evaluated the impact of a 30% financial incentive on~     fruit and vegetable intake among adult participants in the USDA Supplemental Nutrition and~     Assistance Program (SNAP).~   "
69974|NCT02651051|"~     The purpose of this study is to investigate whether the addition of whey protein to a~     breakfast high in fat content will influence acute metabolic and appetite responses, as well~     as responses to a subsequent lunch meal.~   "
69975|NCT02651038|"~     Micafungin is a cyclic lipopeptide antifungal agent of the echinocandin class. Members of~     this class of antifungal agents are known to inhibit the synthesis of glucan polymers in~     fungal cell walls. The spectrum of activity of micafungin includes Candida (all species,~     including strains resistant to fluconazole), Aspergillus, and Pneumocystis.~      In intensive care patients continuous venovenous haemodiafiltration (CVVHDF) is a~     well-established extracorporal renal replacement therapy with a high clearance rate.~      Pharmacokinetic studies of antifungal agents in critically ill patients treated with CVVHDF~     are rare. Elimination of any given drug by renal replacement therapy is determined by several~     major factors which are membrane specific, due to physico-chemical properties of the drug and~     characteristics of the renal replacement technique used.~      Ten intensive-care patients with acute renal failure and suspected or proven candida~     infection are included into the study.~      100 mg Micafungin will be infused over a period of sixty minutes via a central venous~     catheter, different from the venous catheter used for CVVHDF. Blood samples will be drawn on~     days 1 and 2 from the arterial and venous line of the extracorporeal circuit at 0, 2, 4, 6, 8~     and 24h after starting the infusion. Plasma and ultrafiltration samples, collected from the~     outlet of the ultrafiltrate compartment of the hemofilter, will be taken at corresponding~     times.~      The following pharmacokinetic parameters will be determined: area under the curve (AUC),~     half-live (t1/2), maximum plasma concentration (Cmax) and elimination fraction.~   "
69976|NCT02651025|"~     The purpose of this study is to determine whether a supervised resistance exercise training~     during hemodialysis is effective to increase physical activity in daily life in patients with~     end stage renal disease.~   "
69977|NCT02651012|"~     A Study to Evaluate the Efficacy and Safety Sarecycline in the Treatment of Acne Vulgaris.~   "
69978|NCT02650999|"~     Single center, phase I/II trial of pembrolizumab after CTL019 for CD19+ lymphomas. Patients~     will have CD19+ diffuse large B-cell, follicular, or mantle cell lymphomas~     relapsed/refractory after CTL019. 12 total patients will be enrolled. Safety of pembrolizumab~     (primary endpoint) will be determined using a Bayesian monitoring rule for treatment-related~     adverse events causing drug discontinuation. Secondary efficacy endpoints include overall~     response rate and progression-free survival.~   "
70623|NCT02642562|"~     This study will address whether the additional use of Intravenous (IV) iron on top of~     standard care will improve the outlook for patients with heart failure and iron deficiency.~     One group of participants will receive treatment with iron injections and the other group~     will not receive any iron injections.~   "
69979|NCT02650986|"~     This phase I/IIa trial studies the side effects and best dose of a gene-modified T cells and~     to see how effective it is in treating patients with solid tumors expressing cancer-testis~     antigens 1 (NY-ESO-1) gene that have spread from where it started to nearby tissue or lymph~     nodes (locally advanced) or have spread to other places in the body (metastatic). A T cell is~     a type of immune cell that can recognize and kill abnormal cells of the body. Placing a~     modified gene for NY-ESO-1 into the patients' T cells in the laboratory and then given them~     back to the patient may help the body build an immune response to kill tumor cells that~     express NY-ESO-1. Drugs used in chemotherapy, such as cyclophosphamide work in different ways~     to stop the growth of tumor cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading, and it may also allow genetically modified T~     cells to grow.~   "
69980|NCT02650973|"~     This is a randomized, single-blind, 3-period crossover study in healthy subjects to assess~     PK, PD, and safety (including immunogenicity) of a single 6mg subcutaneous injection of~     CHS-1701 (Coherus pegfligrastim) or 6mg SC dose of Neulasta (pegfilgrastim) given during each~     period.~   "
69981|NCT02650960|"~     The Flemish version of the Life Balance Inventory (LBI), measuring central constructs of life~     balance, will be validated in a stroke population. Upon approval by the ethical committee,~     stroke patients will be recruited when they are at least six months post stroke (n = 30). The~     LBI will be administered twice with one week interval, and demographic, socio-economic~     variables and other measures of health related quality of life will be collected.~      Next, an observational prospective longitudinal study will be set up. We will recruit stroke~     patients in three rehabilitation centers within one week after admission in the~     rehabilitation center. Patients will undergo a baseline evaluation and will be re-assessed at~     discharge from the rehabilitation center, at six months and at 12 months post stroke. A~     standardized clinical assessment battery, measuring motor, sensory, cognitive, mental and~     functional outcomes as well as personal and environmental factors will be administered. This~     observational study will explore recovery patterns of bimanual activities after stroke from~     baseline evaluation to six and 12 months after stroke. Also the predictive value of motor,~     sensory, cognitive and mental outcomes on bimanual activities at six and 12 months post~     stroke is studied, based on data collected on admission to the rehabilitation center.~     Finally, changes over time in life balance and its determinants will be examined at six and~     12 months post stroke. The predictive value of motor, cognitive and functional outcomes on~     life balance at one year post stroke will be examined, based on data collected on admission~     to the rehabilitation center. Furthermore the influence of bimanual activities on life~     balance will be explored in the chronic stage after stroke.~   "
69982|NCT02650947|"~     Hypothesis:~        1. Long-term consumption of sucralose may effect glucose metabolism, incretin hormone~          secretion and gut microbiota in healthy adults.~        2. Long-term consumption of sucralose may alter food behaviour in healthy adults.~   "
69983|NCT02650934|"~     Objective: The purpose of this project is to study the post miyocardial infaction (MI) damage~     and subsequently developed post-infarct cardiac repair process on the basis of cellular,~     molecular and imaging techniques. Besides this, whole genomesequencing and analysis (GWAS)~     will be performed to determine common varying genetic loci in order to anticipate~     whetherthese findings and its related pathways would be the predictors of adverse remodeling~     after MI or not.~   "
69984|NCT02650921|"~     This is a randomized, evaluator-blind, split hand, multi-center study of the effectiveness~     and safety or Restylane Lyft with Lidocaine compared to no treatment for injection in the~     dorsal hand to correct volume deficits.~   "
69985|NCT02650908|"~     The most common technique involves a suture meniscus avivement with a rasp or a motorized~     cutter the suture zone before actual implementation of the suture. But the imperative nature~     of this avivement is based only on theoretical considerations. The team has an old experience~     in conducting meniscus sutures without avivement. It therefore seems interesting to compare~     results with those of literature~   "
69986|NCT02650895|"~     The purpose of this study is to evaluate the safety and tolerability of single ascending~     intravenous (IV) doses of CD24Fc in healthy adult subjects.~   "
69987|NCT02650882|"~     This study investigated the effects of an inspiratory muscle training (IMT) program on the~     respiratory muscle strength and resistance and the aerobic physical performance (PP) of~     handball athletes. Nineteen male athletes took part in the study, allocated at random into~     the experimental group (EG, n=10) and the placebo group (PG, n=9), aged 19±1 and 22±5 years~     old, respectively. The respiratory muscle strength (RMS) was evaluated by measuring the~     maximum inspiratory and expiratory pressures (MIP and MEP, respectively), the muscular~     respiratory resistance was evaluated by maximum voluntary ventilation (MVV) and the aerobic~     PP by applying the cardiopulmonary exercise test. Subsequently the volunteers were submitted~     to an IMT protocol 5 times a week for 12 weeks.~   "
69988|NCT02650869|"~     This prospective randomized double-blind control trial is carrying out in the neonatal unit~     of Sylhet MAG Osmani Medical College Hospital, Sylhet between July 2012 to December 2015 with~     the diagnosis of preterm (<33 weeks gestation) VLBW (birth weight <1500g) and fulfilling the~     inclusion criteria (able to tolerate oral feed and survive beyond 48h of life) were included~     in this study. Babies with suspicion of clinical sepsis, presence of perinatal asphyxia,~     major congenital anomaly and babies who expired due to other neonatal illness were excluded.~     Gestation was assessed from history of last menstrual period and after birth by new Ballard~     scores. A study protocol was approved by the Institutional Ethics Committee of Sylhet M.A.G~     Osmani Medical College, Sylhet.~   "
69989|NCT02650856|"~     The investigators will include patients who will be schedule for total knee arthroplasty with~     a diagnosis of osteoarthritis. The patients will be divided in two groups. In both groups a~     verbal and clear detailed information will be given on the intraoperative approach. The first~     group will receive topical tranexamic acid and the second group topical platelet rich plasma;~     both in the surgical site. Both groups will be assessed before and after the intervention~     with clinical scales (VAS) and laboratory results (hemoglobin, hematocrit levels) and~     transfusion rate.~   "
69990|NCT02650843|"~     This project aims to clarify the role non-motor symptoms in the development of Parkinson's~     disease (PD) and to improve diagnostics at very early stages of PD. The project involves~     multidimensional measures of disease biomarkers together with brain dopamine transporter~     (DAT) imaging with [123I]FP-CIT single photon emission computed tomography (SPECT).~   "
69991|NCT02650830|"~     The goal of this work is to critically test the hypothesis that there exists a different~     profile of bile acids (BAs) in patient with type 2 diabetes mellitus (T2DM) compared with~     normal controls. Through confirmation of different profile of BAs in T2DM, investigator will~     suggest modulation of specific bile acids as a new possible treatment target in patients with~     T2DM. Investigator also expect the specific BAs signature will be used to screen T2DM before~     hyperglycemia.~      In addition, investigator will evaluate the association between each BA species and serum~     total glucagon like peptide-1 (GLP-1) or fibroblast growth factor-19 (FGF-19) concentrations~     to determine if the specific BAs profile is related with total GLP-1 or FGF-19 concentration~     in serum. Investigatr also evaluates the correlation between each BA species and metabolic~     profiles and oxidative stress marker to find possible roles of each BA component in glucose~     metabolism.~   "
69992|NCT02650817|"~     The purpose of this study is to visualize and quantify ER-binding sites during treatment with~     Elacestrant (RAD1901)~   "
69993|NCT02650804|"~     This is a Phase 2 multicenter, open-label, non-randomized study to examine the safety and~     effectiveness of BPM31510 administered as a 144-hour continuous intravenous (IV) infusion as~     a monotherapy or in combination with gemcitabine in advanced pancreatic cancer patients as~     2nd / 3rd line therapy. The study will enroll up to 50 patients in the US and Europe.~   "
69994|NCT02650791|"~     It is hypothesized that a strategy using prophylactic oral Tranexamic Acid (TXA) with~     therapeutic platelet transfusions is safe and effective compared to prophylactic platelet~     transfusions in patients undergoing an autologous hematopoietic stem cell transplantation~     (who are at risk for bleeding).~   "
69995|NCT02650778|"~     Women with dense breasts (BIRADS 3 or 4) with a BIRADS category 1 or 2 mammogram are asked to~     participate in a automated volume breast ultrasound scanner. The study evaluates~     prospectively the changes in recall rate, positive biopsy rate, cancer detection rate when~     BIRADS category 3 lesions are given a 1 year follow-up recommendation.~   "
69996|NCT02650765|"~     A prospective validation study of the Scandinavian guidelines for initial management of~     minimal, mild and moderate head injuries in adults. Enrolling a consecutive sample of 1000~     adult head injury patients from the emergency department of the Tampere University Hospital~     (Tampere, Finland). A venous blood sample with S100 analytics (+storage blood) is drawn from~     every patient. The patients are head CT-scanned according to the SNC guidelines. Outcome~     assessment (GOSE, MRS, Rivermead PCS Questionnaire) is completed as follows: 1 week, 6~     months, 1 year, and 2 years.~   "
69997|NCT02650752|"~     The purpose of this study is to see if capecitabine can be taken safely with different doses~     of lapatinib in patients with HER-2 positive breast cancer involving brain (brain metastases)~     and/or in spinal fluid (leptomeningeal disease).~   "
69998|NCT02650739|"~     The efficacy of macular hole (MH) surgery with the halting of prone positioning by monitoring~     the MH closure in the swept source optical coherence tomographic (SS-OCT) images was compared~     with the surgery by the surgeon's decision. The macular hole closure and visual outcome were~     compared.~   "
69999|NCT02650726|"~     HDL function is impaired in patients with type 2 diabetes mellitus. Anthocyanin, a~     water-soluble compounds,is beneficial for vascular function by increasing nitric oxide (NO)~     bioavailability and decreasing oxidative stress. This study was designed to evaluate whether~     anthocyanin supplementation might improve cardiovascular function in diabetic patients.~   "
70000|NCT02650713|"~     This is an open-label, multicenter, dose-escalation and expansion Phase Ib clinical study of~     RO6958688 in combination with atezolizumab.~   "
70001|NCT02650700|"~     Chemotherapy is one of the main treatments for advanced NSCLC. However, chemotherapy induced~     thrombocytopenia (CIT) is one of the most important limitations for subsequent chemotherapy~     of cancer.~      At present, although platelet transfusion is the gold standard to treat severe CIT, its~     clinical application is limited due to many disadvantages, such as short time for storage,~     not easy to save, the risk of infection and immunological diseases. What's more, other~     cytokines including IL-11 and rhTPO, are not so useful in clinical work. It is necessary to~     explore a new therapeutic method to treat CIT.~      Researches show that spleen resection could improve the count of PLT. In this clinical trial,~     we design chemotherapy plus spleen radiotherapy to the subjects with advanced NSCLC,~     simultaneously, who underwent grade II or worse CIT. The primary endpoint is the incidence of~     severe CIT (≧grade III) in subsequent chemotherapy, the second endpoints are recovery time~     from bone marrow suppression and progression free survival, and the exploring index is the~     immulogical status.~   "
70002|NCT02650687|"~     This study will recruit surgical patients more than 65 years old. Patients who participate~     will wear a sticker on their forehead during surgery which monitors their brain waves~     (electroencephalogram, EEG) and participate in memory testing before and after surgery. Brain~     wave patterns will be compared between patients who have problems with memory and thinking~     after surgery and those who do not. The hypothesis is that there will be characteristic brain~     wave patients for who will go on to have problems with memory and thinking after surgery.~   "
70003|NCT02650674|"~     This study aimed at determining the Glycaemic Index and Insulinaemic Index Values of Five~     Cereal Products in two different ethnic groups.~   "
70004|NCT02650661|"~     The purpose of this study is to evaluate the efficacy of the Smart Management Strategy for~     Health (SMASH) program, which is designed to help cancer patients overcome their cancer~     crisis proactively and grow positively.~   "
70005|NCT02650648|"~     This is a phase I study. The purpose of this study is to see if it is safe and feasible to~     give the participant cyclophosphamide (a type of chemotherapy), natural killer (NK) cells,~     and an antibody called Hu3F8 as a treatment for neuroblastoma. NK cells are a type of white~     blood cell.~      Funding Source- FDA OOPD~   "
70006|NCT02650635|"~     This phase Ib trial studies the best way of TLR8 Agonist VTX-2337 and cyclophosphamide in~     treating patients with a solid tumor that has spread from the primary site (place where it~     started) to other places in the body (metastatic), progressed for a long time (persistent),~     come back (recurrent), or is growing, spreading, or getting worse (progressed). TLR8 Agonist~     VTX-2337 may stimulate the immune system in different ways and stop tumor cells from growing.~     Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the~     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Giving TLR8 Agonist VTX-2337 together with cyclophosphamide may~     be a better treatment for solid tumors.~   "
70007|NCT02650622|"~     This is a prospective, non-randomized, non-blinded observational study. The overarching goal~     is to discover new disease-associated genes in children, while establishing a specific focus~     on disorders where molecular characterization is most likely to lead to novel therapies. This~     study will merge detailed phenotypic characterization of patients presenting to the Pediatric~     Genetics and Metabolism Division in the Department of Pediatrics/Children's Medical Center at~     Dallas and collaborating clinics with Next-Generation sequencing techniques to identify~     disease-producing mutations. The primary objective of the study is to identify novel~     pathogenic mutations in children with rare Mendelian disorders. A secondary objective of the~     study is to establish normative ranges of a large number of metabolites from healthy newborns~     and older children.~   "
70008|NCT02650609|"~     Chronic subdural hematomas are a frequent neurosurgical pathology in the elderly. Gold~     standard is surgical evacuation of these hematomas. Physiopathology of chronic subdural~     hematoma involves numerous inflammatory processes which could be inhibited by steroids.~   "
70009|NCT02650596|"~     The investigators planned to evaluate the effects of liraglutide on left ventricular function~     in chronic heart failure patients with type 2 diabetes.~   "
70010|NCT02650583|"~     This pilot clinical trial studies the use of the Enhancing Connections Program in improving~     communication between patients with incurable cancer and their children. The Enhancing~     Connections Program is an educational program that may provide patients with new competencies~     to improve communication with their children and help them to cope with their parent's~     incurable cancer.~   "
70011|NCT02650570|"~     The purpose of this study is to determine whether skeletal muscle mitochondrial function is~     altered in patients with head and neck cancer compared to healthy controls.~   "
70012|NCT02650557|"~     The investigators aimed to investigate the vessel heterogeneity of Thrombolysis in Myocardial~     Infarction frame count (TFC) in the three coronary arteries, and its relation to P-wave~     dispersion, in patients with coronary slow flow and otherwise normal coronary arteries.~   "
70013|NCT02650544|"~     This is a phase II, placebo-controlled, randomized, double-blinded clinical trial. Study~     objective is to assess the efficacy and safety of mirtazapine in advanced NSCLC patients with~     malignant tumor related depression. Study hypothesis is that advanced NSCLC diagnosed with~     depression undertaking palliative chemotherapy with mirtazapine treatment for 8 weeks will~     have remarkable improvement in depression compared to baseline. Eligible advanced NSCLC~     Patients with PHQ-9 score ≥ 8, and undertaking palliative chemotherapy will be enrolled into~     this study. patients will be stratified (gender, age, Numerical Rating Scale score for cancer~     pain 0-3/4-6/7-10) randomized (1:1) into mirtazapine or placebo treatment. Patients in~     mirtazapine arm will be orally administered with mirtazapine 15mg, QD, consecutive medication~     for 8 weeks; along with palliative chemotherapy regimen decided by investigators. Patients in~     placebo arm will be orally administered with placebo 15mg, QD, consecutive medication for 8~     weeks; along with palliative chemotherapy regimen decided by investigators. During the~     treatment, Patient health questionnaire (PHQ-9), Hamilton Depression Scale (HAMD-17) and~     European Organization for Research on Treatment of Cancer (EORTC) quality of life~     questionnaire-C30 (QLQ-C30) questionnaires will be collected at baseline, 3 weeks (d22) and 8~     weeks (d57), or treatment discontinuation date due to depression deteriorated or suicidal~     tendency and behavior. Follow-up will last up to 4 weeks after treatment end with depression~     assessment (questionnaires every 2 weeks). Study endpoints: primary endpoint is the~     anti-depression efficacy (response rate). Response defined as the PHQ-9 or HAMD-17~     questionnaire score decrease ≥ 50% compared with baseline level.~   "
70014|NCT02650531|"~     A prospective observational multicenter study aiming to describe incidence, and identify~     predictors for development of poststroke dementia (PSD) and mild cognitive impairment (MCI)~     after stroke~   "
70015|NCT02650518|"~     Hypothesis: A short course (3-5 days) of antibiotic therapy (experimental arm) is as safe and~     effective as a long course of antibiotic therapy for the treatment of catheter-associated~     urinary tract infections.~   "
70016|NCT02650505|"~     This is a randomized, single-center, controlled, within-subject comparison study assessing~     the sensitization potential of the investigational product, LEO 43204 gel under open~     conditions in healthy volunteers.~      LEO 43204 Gel and Vehicle Gel will be applied to adjacent sites on the infrascapular area of~     the back. Evaluation of dermal reactions at the application sites will be assessed clinically~     using a visual scale that rates the degree of erythema, edema and other signs of cutaneous~     irritation.~      Following induction, subjects will have a 10 to 14-day Rest Phase, after which they will~     enter the Challenge Phase, which consists of one 48-hour application to a naive site on the~     opposite side of the back. Observations at the naive site during Challenge and the patterns~     of reactivity during the Induction Phase will provide a basis for an interpretation of~     contact sensitization.~      A total of 10 applications will be made over a period of approximately 6-8 weeks.~   "
70017|NCT02650492|"~     Thermotherapy is a technology aiming at destroying tissue, for example tumor tissue.~     Immunostimulating Interstitial Laser Thermotherpy (imILT) is a specific form of~     thermotherapy, which, in addition to destroying tumor tissue, has been optimized to cause a~     tumor specific immunologic response. In laboratory animals the imILT method has also been~     shown to induce a so called abscopal effect. This means that when one tumor is treated with~     imILT other, untreated, tumors also decrease in size. The immunologic response has previously~     been characterized in breast cancer patients after receiving imILT treatment , and presumed~     abscopal effects induced by imILT have also been described in a malignant melanoma patient.~      The purpose of this trial is to investigate the functionality and safety of the imILT~     treatment method in patients diagnosed with malignant melanoma. The inflammatory process,~     following on the treatment, will also be described in order to provide a more in depth~     knowledge of the treatment for this indication. The purpose is also to evaluate efficiency~     when it comes to local tumor destruction as well as understanding of the subsequent~     immunological effects. Since immunologically based treatment of malignant melanoma is under~     intense review with so called immune checkpoint inhibitors this trial will also provide~     valuable information on how imILT, in the future, could be combined with these new and, for~     some patients, very effective treatment regimens.~      The treatment method has successfully been used for treatment of patients with breast cancer~     and malignant melanoma . Treatment of breast cancer patients caused an increase of cytotoxic~     T lymphocytes in the treated tumor, as well as activated dendritic cells at the tumor border.~     Regulatory T lymphocytes decreased in the regional lymph nodes.~      This trial is explorative, prospective, open and non-randomized. Five malignant melanoma~     patients stage III - IV will be treated in this trial, which is estimated to be carried out~     during a time period of 12 months.~   "
70018|NCT02650479|"~     Two-Part, Randomized, Placebo and Active-Controlled, Double-Blind, Thorough QT Study~     Evaluating the Effects of Intravenous Exenatide on Cardiac Repolarization in Healthy Male and~     Female Volunteers~   "
84228|NCT02464540|"~     The aim of this randomized clinical trial is to evaluate the influence of luting agent,~     thickness and color of laminate veneers (LVs) and color of dental substrate on the optical~     properties of LVs.~   "
70019|NCT02650466|"~     The purpose of this study is to determine if the Nanopulse System can be used to clear common~     wart lesions on the skin. The Nanopulse System uses a series of low energy, high voltage~     pulses, each one several billionths of a second in duration, to effectively kill the target~     tissue contained within the applicator tip electrodes with minimal damage to surrounding~     tissue. Efficacy and patient outcomes are expected to equal or surpass current treatment~     modalities in terms of increased ease of use, faster patient healing and minimal scarring~     with fewer complications resulting from treatment.~      The device emits significantly less energy than existing electro-surgery or electro-cautery~     equipment and is believed to be similar to laser therapy treatment of warts. Trained~     clinicians can usually diagnose warts based by their appearance and location . Non-genital~     warts are subcategorized into common, periungual, flat, filiform, and plantar types. Common~     warts are benign, often skin-colored, or brown-grey, rough, bumpy growths on the hands and~     feet (caused by Human Papilloma Virus type 2) . Common warts in individuals without any~     immune deficiencies are low risk and are the focus of this study.Based upon the preclinical~     profile of the Nanopulse device, particularly its safety profile and its effect on~     transformed cells, it is hypothesized that application of pulses from the Nanopulse System ,~     will result in complete clinical clearance of Common Wart lesions with minimal scarring.~   "
70020|NCT02650453|"~     Ongoing registration of deep venous obstructive disease patients treated by means of~     percutaneous transluminal angioplasty (PTA) and stenting with or without endophlebectomy~     (surgical desobstruction, also termed endovenectomy) of the common femoral vein and/or~     arteriovenous fistula creation.~   "
70021|NCT02650440|"~     The objective of this study is to compare the effects of novel versus standard locomotor~     training using a robotic gait orthosis (LT-RGO) after stroke. The hypothesis is that the~     novel LT-RGO protocol, by establishing a progressive decrease in gait velocity and guidance~     force, may facilitate greater motor recovery compared to the use of a standard protocol.~   "
70022|NCT02650427|"~     Boosting of tumor cell killing by cytotoxic lymphocytes may be a promising means to enhance~     anti-tumor immunity. Prior studies demonstrated that tumor infiltration by cytotoxic~     lymphocytes correlates with control of tumor growth and is associated with an improved~     prognosis in cancer patients. Trafficking of activated lymphocytes is a tightly regulated~     mechanism and the specific nature of the chemokine milieu is a crucial determinant for~     permitting T cell entry into the tumor microenvironment. CXCL10 is an interferon-inducible~     chemokine particularly important for the recruitment of activated T, and it has been shown to~     enhance anti-tumor responses through its action on cytotoxic T cells (e.g., glioblastoma,~     colorectal adenocarcinoma and lung carcinoma). Additionally, roles for CXCL10 as an~     anti-tumor effector include its ability to chemo-attract NK cells into sites of inflammation,~     and its ability to inhibit development of new vasculature and induce the regression of newly~     formed vessels. Adding a layer of complexity, the function of CXCL10 can be regulated by~     dipeptidylpeptidase IV (DPPIV), leading to the formation of a dominant negative, antagonist~     form of the chemokine. This was initially demonstrated in vitro, and recent work has provided~     convincing in vivo evidence that antagonist forms of CXCL10 regulate lymphocyte trafficking.~     The main goal of this protocol is to evaluate the tolerance of sitagliptin treatment in HCC~     patients, and secondary DPPIV inhibitors as a strategy for protecting CXCL10 chemokine~     agonist activity as a means to enhance tumor regression.~   "
70023|NCT02650414|"~     This is a single center, single arm, open-label pilot study to determine the feasibility and~     safety of a single dose administered as spilt fractions of autologous T cells expressing CD22~     chimeric antigen receptors expressing tandem TCRζ and 4-1BB (TCRζ/4-1BB) co-stimulatory~     domains (referred to as CART22 cells) in pediatric patients with relapsed or refractory~     B-cell acute lymphoblastic leukemia.~   "
70024|NCT02650401|"~     This is a 5-part, open-label, Phase 1/1b multicenter, dose escalation study in pediatric~     patients with relapsed refractory solid tumors; 2) primary CNS tumors; 3) neuroblastoma; 4)~     non-neuroblastoma, extracranial solid tumors with NTRK1/2/3, ROS1 or ALK gene rearrangements;~     and 5) patients who are otherwise eligible but unable to swallow capsules. The study is~     designed to explore the safety, maximum tolerated dose (MTD) or recommended Phase 2 dose~     (RP2D), pharmacokinetics, and antitumor activity of entrectinib.~   "
70025|NCT02650388|"~     Aortic stenosis (AS) is the most common valve disease among the adult population, in the~     majority of the cases it only requires treatment in advanced age. Transcatheter aortic valve~     implantation (TAVI) has become available as an alternative treatment for very high risk or~     even inoperative patients who are suffering from symptomatic aortic stenosis. Until now it~     has been learnt that there are group of patients who are in a very bad condition and who are~     so frail that they do not benefit from TAVI. These patients have worse survival rate and more~     importantly poor quality of life in spite of a successful procedure. Cardiac surgery risk~     scores like Society of Thoracic surgery score (STS) and EUROSCORE are less accurate in aging~     high risk people. In elderly it is principal to make differentiation between utility and~     futility. On the other hand, beside frailty status the main barrier to TAVI is the risk of~     neurological impairment. Neurological injury and impairment in TAVI can occur as~     cerebrovascular event (CVE) and/or neurocognitive dysfunction. The two neurocognitive~     dysfunctions - post-operative delirium (POD) and post-operative cognitive dysfunction (POCD).~     Most cases remain undetected although clinically could be apparent or silent. The~     neurological injury can be observed and/or detected by neuroimaging techniques and cognitive~     trajectories. A well established and validated frailty score based on relatively simple and~     feasible tests could help in our everyday practice to evaluate the prognosis of elderly~     people undergoing TAVI and to determine those patients who really benefit from the procedure.~   "
70026|NCT02650375|"~     This is an open-label, multicenter study designed to assess the safety, tolerability,~     preliminary efficacy and pharmacokinetics of Metatinib Tromethamine tablet in patients with~     advanced or metastatic gastric cancer, liver cancer, colorectal cancer,or con squamous NSCLC.~     Patients receive Metatinib orally 200mg once daily (QD) or 100mg twice daily (BID) until~     disease progression or unacceptable toxicity occurred. The study will determine whether MET~     gene mutation, amplification, as well as MET protein overexpression in tumor tissue correlate~     with treatment efficacy and clinical outcome. The potential PD biomarker for Metatinib will~     also be explored.~   "
84622|NCT02459392|"~     In this prospective multi-centre double-blind trial the effect of the epiduroscopy will be~     examined in (approximately 300) adult patients with low back pain pain caused by failed back~     surgery syndrome (FBSS).~   "
70027|NCT02650362|"~     This study is an interventional prospective observatory single center trial, investigating~     the supraspinal effects of long term paresthesia-free high frequency SCS in FBSS patients~     with back and leg pain completed with resting state functional magnetic resonance (rs fMRI)~     and voxel-based magnetic resonance morphometry (VBM).~   "
70028|NCT02650349|"~     This study is an interventional prospective observatory single center trial, investigating~     the supraspinal effects of long term conventional SCS (60 Hz) and paresthesia-free high~     density SCS in failed back surgery syndrome (FBSS) patients with back and leg pain completed~     with resting state functional magnetic resonance (rs fMRI) and voxel-based magnetic resonance~     morphometry (VBM).~   "
70029|NCT02650336|"~     Biomarkers such as kidney injury molecule-1 (KIM-1) and neutrophil gelatinase-associated~     lipocalin (NGAL) have been used for the early diagnosis of AKI, although with no definitive~     results. The investigators explored the association between plasma aging biomakers such as~     sklotho and contrast induced nephropathy in patients undergoing percutaneous coronary~     intervention (PCI) with contrast injection.~   "
70030|NCT02650323|"~     This registry aims to collect data related to management of patients affected by acute~     coronary syndromes and hospitalized in the Campania Region of Italy~   "
70031|NCT02650310|"~     The embryo transfer implies transportation from the incubator where they have been at 37 ° C,~     to the transfer catheter inside a laminar flow hood whose working surface is also maintained~     at 37 ° C. . From the laboratory to the operating room the embryo is exposed to a temperature~     drop, and consequently thermal stress occurs, which may compromise its future viability.~      The aim of this study is to assess the possible improvement in the clinical results when the~     embryos are transported in a stable device to avoid the drop in temperature throughout the~     transfer process.~      With the use of this thermosetting device heated to 37 ° C, researchers expect a 15% increase~     in pregnancy rates.~   "
70032|NCT02650297|"~     Patients with lymphedema may experience pain and body image issues. This study investigates~     the effect of Combined Decongestive Therapy and pneumatic compression pump on body image in~     patients with lymphedema secondary to breast cancer treatment.42 women with breast cancer~     related lymphedema participated. All patients completed the body image and relationships~     scale. Researchers divided the participants randomly into an intervention (n=21) or control~     group (n=21). In the first phase, CDT was accompanied by use of a compression pump for four~     weeks, three days per week. In the second phase, Combined DecongestiveTherapy was performed~     daily without compression pump for four weeks by patients at home. At the end of each phase,~     both groups completed the questionaire. Researchers analyzed the data with SPSS v.17.~   "
70033|NCT02650284|"~     A prospective, randomised controlled trial evaluating Total Knee Replacement with the Stryker~     Triathlon Primary Total Knee System, compared to Bicompartmental Knee Replacement with~     Restoris MCK Multicompartmental Knee System performed using Stryker's Robotic-arm assisted~     surgery system, Mako.~   "
70034|NCT02650271|"~     This study aims to compare the effect of antiviral therapy with entecavir and lamivudine for~     hepatitis B virus-related hepatocellular carcinoma after radical hepatectomy. Included~     patients will randomly divide into two groups.~   "
70035|NCT02650258|"~     The purpose of this study is to determine and link cadence (the number of steps taken in a~     minute) to the intensity of physical activity (e.g. low-, moderate- and vigorous-intensity)~     in adults (21-85 years old). The investigators anticipate that cadence will be a good~     indicator of exercise intensity. Identifying how cadence relates to activity intensity will~     allow for physical activity guidelines to be communicated to the public in a manner that is~     more accessible to the lay person.~   "
70036|NCT02650245|"~     The investigators specific aim is to evaluate the changes in breath ammonia in comparison to~     blood ammonia and other physiologic markers after a moderate oral protein challenge in~     healthy subjects and subjects with liver cirrhosis.~   "
70037|NCT02650232|"~     To measure the spontaneous baroreflex sensitivity in ambulatory patient, a device made for~     measuring blood pressure beat by beat and continuously, the SOMNOtouch system, could be a~     useful tool. The SOMNOtouch system has never been used to assess the sensitivity of the~     baroreflex. A good correlation for measuring the baroreflex sensitivity between the system~     SOMNOtouch and digital photoplethysmography as a reference method is expected but should be~     evaluated. The main purpuse is to evaluate the SOMNOtouch system to quantify the spontaneous~     baroreflex sensitivity in healthy young subjects, in elderly healthy subjects and in subjects~     with heart failure. We will also evaluate the feasibility of measuring the baroreflex~     sensitivity in ambulatory conditions for 24 hours, the variations in sensitivity of the~     baroreflex sensitivity between day and night, the reproducibility of orthostatic tolerance~     test.~   "
70038|NCT02650219|"~     Hypergammaglobulinaemia is frequently observed in type 1 Gaucher disease (GD1), being either~     polyclonal or monoclonal gammopathies. Polyclonal hypergammaglobulinemia may be related to~     the presence of autoantibodies. The clinical significance of such antibodies is questioned in~     Gaucher disease (GD), as some cases of immunologic thrombocytopenia and autoimmune hemolytic~     anemia have also been reported.~      Objectives:~      To evaluate the prevalence of autoantibodies and autoimmune diseases in GD1 patients, we~     conducted a multicenter national study. The investigators investigated whether there was a~     link between splenectomy, genotype, therapeutic options and the presence of these~     autoantibodies.They also investigated whether there was a correlation with some clinical~     manifestations of GD1~   "
70039|NCT02650206|"~     The objective of this study is to test the hypothesis that liraglutide (commonly known as~     Victoza) can promote an anti-inflammatory macrophage phenotype in human adipose tissue and~     blood, thereby reducing localized and systemic inflammation which are risk factors for~     cardiovascular disease and may contribute to hyperglycemia. This will be done after 4 weeks~     of treatment during which weight will remain stable, and again after 12 weeks, during which~     liraglutide-related weight loss occurs.~   "
70040|NCT02650193|"~     This is a study of how one or more injections of HSP-130 under the skin effect the white~     blood cell counts and drug levels in women with breast cancer that has not spread to distant~     sites in the body (non-metastatic). This will be studied in women before breast surgery or~     while receiving chemotherapy. Safety will also be studied.~      Additionally, the purpose of this study is to evaluate the effects and safety of single and~     multiple doses of HSP-130 in subjects with non-metastatic breast cancer. This study will~     determine the dose to move forward for future clinical trials.~   "
70041|NCT02650180|"~     The Soberlink Cellular device, in its original packaging, along with the QuickStart guide~     will be provided to the end user in a simulated home use environment or by Rx in clinic. The~     patient labeling will be in the format intended for distribution.~      Ten (10) Rx subjects will be provided instruction for use in clinic for the Soberlink~     Cellular device while an additional ten (10) Rx subjects will be provided instruction for use~     in clinic for the Soberlink Cellular device and Sober Sky web portal. An additional ten (10)~     simulated home use subjects will be provided instruction for use for the Soberlink Cellular~     device while an additional ten (10) simulated home use subjects will be provided instruction~     for use in clinic for the Soberlink Cellular device and Sober Sky web portal. All subjects~     will be provided with a post-test questionnaire on how to operate the device.~      The post-test questionnaire will collect information regarding device use. The device's use~     will be compared with identified risks to determine if the percentage of failures is within~     the study protocol success criteria. Additionally, measurable usability criteria for~     specific, critical steps will be evaluated.~   "
70042|NCT02650167|"~     Colostrum is the first milk secreted by the mother when the tight junctions of mammary~     epithelium open, allowing the cellular transport of a multitude of components and~     immunological protective derivatives of the maternal circulation to the milk, and especially~     immunoglobulins A type. Colostrum is not given to preterm neonates. The assumption behind~     this work is that the oro pharyngeal administration of colostrum early in preterm infants~     could help deliver an oral immunotherapy even before the installation of enteral nutrition,~     through interactions with lymphoid tissues of the oropharynx and the gastrointestinal tract.~     This practice would improve the digestive tolerance and the establishment of enteral feeding,~     the decrease in mucosal inflammatory phenomena, but also to provide any protection against~     subsequent infections. Finally, there could be an improvement in the secondary immune~     tolerance with a decrease in the occurrence of allergic phenomena.~   "
70043|NCT02650154|"~     In the emergency department (ED), ketamine is a popular anesthetic agent during sedation of~     children for painful and other short procedures. Sedation for procedures is more commonly~     used in children than adults, to achieve motion control and cooperation. In children,~     ketamine offers an ideal choice due to the fact that it is short acting, a highly effective~     sedative, and preserves cardio-respiratory stability. In the United States, more than one~     million children per year up to four years of age undergo short procedures requiring~     anesthestic agents, including ketamine. However, there is mounting concern from animal~     studies and retrospective human research regarding the safety of ketamine when administered~     to infants and young children with respect to its potential toxic effects on the developing .~     Conversely, ketamine has also been suggested as a neuroprotective agent. Prompt investigation~     and resolution of this issue is urgently required.~   "
70044|NCT02650141|"~     Due to various complex factors, the incidence of precocious puberty is increasing rapidly. It~     severely threatens physical and mental health of children. It's urgent to explore effective~     ways to control the disease.~   "
70045|NCT02650128|"~     Prospective, multi-center, single arm study designed to evaluate the safety and performance~     of the Shockwave Coronary Rx Lithoplasty® System to treat calcified lesions in the coronary~     arteries for the purpose of enhancing the placement of stents and reducing the ultimate~     residual stenosis. Patients will be followed through discharge and at 30 and 180 days.~   "
70046|NCT02650115|"~     Chronic liver diseases are common and the two main causes in France are NAFLD (No Alcoholic~     Fatty Liver Disease Nonalcoholic) and ALD (alcoholic liver disease).~      Because of the importance of the current global obesity, NAFLD has become very common and it~     is estimated that its prevalence in the general population reaches 20-30%.~      NAFLD (No Alcoholic Fatty Liver Disease Nonalcoholic) and ALD (alcoholic liver disease)~     includes a broad spectrum of liver damage, ranging from simple steatosis isolated~     (infiltration of fat in the liver), in hepatic inflammation, fibrosis (abnormally high~     accumulation of extracellular components in the functional liver tissue) and finally~     cirrhosis and its complications.~      Choline deficiency (essential nutrient generally classified as Class B vitamins) has been~     associated with liver damage each characterizing NAFLD and ALD. The amount of choline in the~     body depends in particular on food intake and degradation of choline by the intestinal~     microbiota.~      NAFLD and ALD are complex pathologies resulting from the interaction of environmental /~     nutritional factors and a genetic background. It therefore appears now necessary to study the~     influence of the relationship between genetic predisposition, environmental factors, and gut~     microbiota metabolism of choline on the severity of liver injury observed in NAFLD and ALD.~      If the interaction of these three elements (the host genetics - environmental factors - and~     intestinal microbiota metabolic choline) has an influence on the severity of the lesions of~     NAFLD and ALD direct application may be of bring a food supplement choline in patients at~     risk (mutation of the PEMT gene (phosphatidylethanolamine N-methyltransferase),~     postmenopausal women, microbiota profile for increased degradation of dietary choline) to~     restore the amount of choline in the body and thus to avoid a worsening of the ALD or NAFLD~     and progression to cirrhosis.~   "
70047|NCT02650102|"~     The aberrant expression of micro-RNAs (miRNAs) has been described in many human diseases,~     including schizophrenia (SZ). The previous work has indicated a strong genetic association~     between the miRNA-30e precursor (pre-miR-30e) and the risk of SZ. However, to date, few~     reports have focused on the expression level of the miR-30 family (miR-30s) and its networks~     of co-regulation in SZ, even in response to antipsychotic treatment. Given this, the~     investigator first constructed a hybrid miRNA-TF (transcription factor)-gene-PPI~     (protein-protein interactions) network focusing on miR-30s by bioinformatics technology. The~     investigator then selected several candidate miR-30s and key regulators for further~     validation. These candidates were then quantified by real-time quantitative PCR (qRT-PCR) in~     an independent cohort of 200 healthy controls and 200 drug-free SZ patients, among which were~     followed up by 12-week antipsychotic treatment. Furthermore, the investigator evaluated the~     correlation between the change in gene expression and the improvement of symptoms.~   "
70048|NCT02650089|"~     Both work activity and reduced nocturnal dipping of blood pressure are related to increased~     cardiovascular risk. The aim of the present study was to assess the hemodynamic and autonomic~     responses of university professors during teaching and sleeping times after different~     resistance exercise intensities. Ten normotensive professors (33.6±3.4 years, 82.4±12.4 kg;~     177.0±7.5 cm) randomly underwent control and resistance exercise before initiating their~     daily activities. Resistance exercise consisted of a circuit training lasting 40min at 40%~     and 80% of one repetition maximum test. Systolic blood pressure and diastolic blood pressure~     as well as heart rate variability indicators in the time and frequency domains (Low~     Frequency, High Frequency, Low Frequency:High Frequency ratio) were evaluated on resting and~     24 hours after the sessions. The average day-time, night-time and nocturnal blood pressure~     fall of systolic blood pressure and diastolic blood pressure were calculated.~   "
70051|NCT02650050|"~     Diabetes is a major cause of blindness in adults in the developed countries. The retinal~     damages associated with diabetes lead to gradual loss of vision, which is accentuated when~     the macula is affected. This results in macular edema.~      Currently, intravitreal injections of anti-VEGF have demonstrated their effectiveness and are~     the first line treatment of macular edema.~      Subthreshold micropulsed laser photocoagulation is an alternative to conventional grid~     photocoagulation. By delivering pulsed impacts under the thermal lesion threshold of the~     pigment epithelium, it would not cause the side effects of conventional photocoagulation.~     Micropulsed photocoagulation combined to anti-VEGF injections, could be the most effective~     treatment with a minimum injection number and without epithelial lesions.~      The main objective of this study is to show that the subthreshold micropulsed laser~     photocoagulation, in association with intravitreal injections of anti-VEGF, allows to reduce~     the number of anti-VEGF injections during the first year of treatment.~      In this randomized, double blind study, eligible patients will be randomized between a~     micropulsed laser photocoagulation arm and a sham micropulsed laser photocoagulation arm.~   "
70052|NCT02650037|"~     Anesthesia-induced atelectasis persist in the postoperative period but are not usually~     diagnosed because imaging techniques are required. The aim of the study is to determine~     whether the value of SpO2≤96 while breathing room air (0.21 FiO2) for 5 min, maneuver that we~     defined as the Air Test, was able to diagnose atelectasis in the postoperative period after a~     general anesthesia.~   "
70053|NCT02650024|"~     This partially blinded placebo-controlled trial will determine the impact of curing Hepatitis~     C Virus (HCV) with an oral direct-acting antiviral (DAA), ledipasvir and sofosbuvir in a~     single pill, on central nervous system (CNS) outcomes in mono- or Human Immunodeficiency~     Virus (HIV) co-infected individuals.~   "
70054|NCT02650011|"~     Chronic liver disease including liver cirrhosis is still associated with high mortality,~     although advancement of medical management and transplantation. Acute-on-chronic liver~     failure (ACLF) refers to condition of previously stable chronic liver disease with occurrence~     of an acute insult resulting in rapid deterioration of liver function and subsequent~     decompensation. This condition is different from liver cirrhosis (chronic hepatic~     decompensation) in terms of having more chance of recovery with management before acute~     deterioration, although it shows high short-term mortality. Thus, earlier recognition and~     intensive management are important for this condition. However, the definition or diagnostic~     criteria is unclear and the natural course of this condition is not definitely investigated.~     The aim of this study is to establish the natural course of ACLF in Korean patients.~   "
70055|NCT02649998|"~     Background:~      Acute decompensated heart failure (ADHF) is a common and potentially fatal cause of acute~     respiratory distress that requires immediate treatment in emergency department. The mortality~     rates are as high as 20% after discharge. Currently, furosemide is the most commonly used~     medicine in emergency department for ADHF. Although nitrate was proved to generate similar~     effect when compared to furosemide, less than 30% of patients received nitrates. This~     practice happens not only in Hong Kong, but also all around the world. Moreover, there is~     limited evidence to support a difference in ADHF patients receiving intravenous nitrate~     vasodilator therapy or alternative interventions.~      The aims of the study are:~        1. To monitor the changes in concentration of cardiac biomarkers, VAS dyspnoea score and~          cardiac output before and after treatment of furosemide, isosorbide dinitrate or both.~        2. To investigate whether the changes in concentration of cardiac biomarkers, VAS dyspnoea~          score and cardiac output before and after treatment is associated with the change in~          length of hospital stay.~        3. To investigate whether combination treatment with intravenous furosemide and isosorbide~          dinitrate in patients with HF reduces VAS dyspnoea score, in-hospital mortality, length~          of hospital stay and number of readmission to a higher extend than do either medication~          alone.~        4. To evaluate the prognostic values of novel cardiac biomarkers on 7-day, 14-day, 30-day~          and 6-month mortality and readmission.~      Design:~      This single-blinded randomized controlled study will be conducted in the Prince of Wales~     Hospital in Hong Kong.~      Setting and Subjects:~      Patients with dyspnoea will be screened and recruited from adult patients attending the~     emergency department at the Prince of Wales Hospital.~      Interventions:~      Patients with acute decompensated heart failure will be randomly treated with intravenous~     furosemide, isosorbide dinitrate or both. Level of dyspnoea, multi-biomarker and haemodynamic~     parameters will be measured before and after treatment.~      Outcomes:~      The primary outcome is the change in VAS dyspnoea score after treatment of furosemide,~     isosorbide dinitrate or both. The secondary outcomes are the changes in concentration of~     biomarkers and cardiac output, the number of in-hospital mortality, length of hospital stay,~     7-day and 30-day and 6-month mortality and readmission.~   "
70056|NCT02649985|"~     The specific aims of the study are:~      Primary: To determine the presence and regional distribution of microglial activation, as~     assessed by Fluorine-18 (18F) labeled Peripheral Benzodiazepine Receptor 06 (PBR06) -PET,~     in subjects with active Relapsing Remitting Multiple Sclerosis (RRMS), Secondary Progressive~     Multiple Sclerosis (SPMS), and Alzheimer's Disease (AD) as compared to healthy controls~      Secondary:~        1. To assess the relationship between microglial activation and clinical variables~          including disease severity and comorbidities (such as pain, fatigue and/or depression),~          as well as clinical MRI findings (such as lesions and atrophy)~        2. A pilot substudy aims to establish the non-inferiority of [F-18]PBR06 as compared with~          Carbon-11 [C-11] labeled Peripheral Benzodiazepine Receptor 28 (PBR28) PET in patients~          with RRMS.~      Hypothesis: The working hypothesis is that there is microglial activation in multiple~     sclerosis and Alzheimer's disease as compared to healthy controls and that the pattern/~     regional distribution of microglial activation is different in Multiple Sclerosis (MS) versus~     AD and correlates with disease severity and comorbidities.~      In addition, the investigators hypothesize that [F-18]PBR06-PET scans will be at least as~     good as [C-11]PBR28-PET scans, the current gold standard.~   "
70057|NCT02649972|"~     The purpose of this study is to find out what effects, good or bad, Cobimetinib has in~     patients with histiocytosis. Cobimetinib is an investigational oral medication that blocks~     MEK1.~   "
70058|NCT02649959|"~     This is a Phase III, open label extension study evaluating the continued safety and efficacy~     of CM-AT in pediatric patients with autism with all levels of fecal chymotrypsin.~   "
70059|NCT02649933|"~     To assess prevalence of obstructive sleep apnea during pregnancy and its impact on prgnancy~     course and materno foetal wellbeing.~   "
70060|NCT02649920|"~     At the moment in France, one delivery on four is induced for a medical indication. In this~     context, the practitioners are exposed to an additional difficulty when the clinical~     examination of the patient reveals a unfavorable cervix because the main drug used for the~     releases cannot be used and the cervix must be previously mature.~      There is a pharmacological method used and estimated in these indications of cervical~     maturation: the dinoprostone (Propess®).~      Other methods using a mechanical process, are under development and of evaluation as it is~     the case of the probe of dilation with double balloon (Cook®).~      The population of the obese women is a population in constant increase in France and~     presenting deliveries to higher risks of maternal and foetal complications. At these~     patients, the medicinal releases seem also more difficult and at greater risks of failures.~      The investigators wish compared the efficiency of the cervical ripening balloon to the~     dinoprostone within the framework of a medical indication in a release with a unfavorable~     cervix in obese pregnant women.~   "
70061|NCT02649907|"~     Investigative trial with aim of~        1. the description of the hormonal and metabolic response to meals containing different~          compositions of macronutrients~        2. the metabolic response to these test meals in dependance of the hepatic and muscular~          insulin sensitivity and abdominal adipose tissue and~        3. effects of a weight loss on the hormonal response to these test meals containing~          different compositions of macronutrients~      Primary endpoint:~      Glucagon-like-peptide 1 (GLP-1), Glucose dependent insulinotropic peptide (GIP) and Ghrelin~     response to a nutritive stimulation characterized by different nutritional composition~      Secondary endpoints:~        -  differences of substrate utilization depending on the nutritive composition~        -  effects of different hepatic and muscular insulin sensitivity as well as impact of~          visceral fat mass on the hormonal and metabolic response~        -  effect of weight loss on the hormonal and metabolic response to different test meals~      Study procedure:~      After primary characterization 50 probands (male and female) will receive 3 different test~     meals within a randomised (meal order) controlled trial.~      The three different test meals differ in nutritional composition. During consumption of the~     test meal a characterization of the endogenous hormonal response and appetite behaviour is~     performed.~      A nutritional counselling is performed according to the guidelines of the German Nutrition~     Society (DGE) to ensure a stable nutritive behaviour in the three days before the test meal~     administration.~      After analysis of the hormonal response to these 3 different testmeals follows a weight~     reduction period over 3 months. Afterwards reevaluation of the probands (again administration~     of 3 different test meals over a period of 3 weeks) will be performed.~      Principal aim of the study:~      Gain of information leading to the understanding of the hormonal regulation of food intake.~     The individual variability shall be determined with the aim of an identification of patient~     groups which show various intensities of the responses to different macronutrients.~   "
70062|NCT02649894|"~     The purpose of this study is to determine whether a new catheter is safe and effective in~     treating malignant pleural effusions compared to approve catheter.~   "
70063|NCT02649881|"~     This study evaluated optimal macrophage diagnosis algorithm through comparative analysis~     between coronary artery, OCT image, and IVUS, and improve a diagnosis rate of vulnerable~     coronary plaque accompanied with macrophage infiltration.~   "
70064|NCT02649868|"~     Background:~      Liver cancer begins in the cells of the liver. It can be treated with chemotherapy,~     radiation, or even a liver transplant. A less invasive treatment may be able to help some~     people with liver cancer. It is called percutaneous transarterial embolization (TAE). For~     TAE, a material is injected into blood vessels to block the blood flow that is feeding the~     tumor. Researchers want to test a new material for TAE that may shrink tumors and can be seen~     on x-ray and CT images. The embolization may sometimes be combined with thermal ablation, or~     cooking tumors with needles that deliver heat by electricity or microwave.~      Objective:~      To test an embolization material called an LC LUMI beads. To see if it can block blood~     vessels that provide blood to cancerous tumors and to see how the beads look on x-ray and CT~     images.~      Eligibility:~      Adults 18 85 years old who have been diagnosed with liver cancer~      Design:~      Participants will have routine blood tests, physical exams, and x-rays.~      Participants will be screened with blood tests, physical exam, and medical history. They will~     have a computed tomography (CT) scan of the abdomen and pelvis. This will include a contrast~     drink and a contrast (dye) injected in the veins.~      Participants will be admitted to the clinic. They will repeat the screening tests.~      Participants may have other tests. These may include x-rays, other scans, or ultrasound.~      Participants will be evaluated for general anesthesia.~      They will get counseling about the procedure.~      Participants will get anesthesia. The LC LUMI beads will be injected into blood vessels. The~     beads contain iodine, which makes them visible by x-ray and by a CT scan machine.~      Participants will have follow-up visits for 12 months. They will have CT scans and/or other~     radiologic tests.~   "
70065|NCT02649855|"~     Background:~      Metastatic castrate-sensitive prostate cancer is cancer that has spread beyond the prostate~     area. It can be controlled by lowering the amount of testosterone in the body. This is called~     androgen deprivation therapy (ADT). The vaccine PROSTVAC might help the immune system kill~     cancer cells. Researchers want to add PROSTVAC and docetaxel chemotherapy to ADT. They think~     this may work better against prostate cancer than ADT alone.~      Objective:~      To test if adding PROSTVAC and docetaxel to ADT works better against prostate cancer than ADT~     alone.~      Eligibility:~      Men ages 18 years and over with metastatic castrate-sensitive prostate cancer~      Design:~      Participants will be screened with:~      Physical exam~      Medical history~      Blood tests~      Possible CT, MRI, or bone scan: Participants lie in a machine. The machine takes pictures of~     the body.~      Electrocardiogram: Soft electrodes are stuck to the skin to record heart signals.~      Participants will have 2 optional tumor biopsies during the study.~      Participants will join 1 of 2 groups. Both groups will get:~      ADT~      Docetaxel by vein~      Steroids by mouth or vein before each docetaxel infusion~      PROSTVAC injection~      Both groups first have ADT. One to 4 months after, they have:~      Group A:~      Docetaxel every 3 weeks for 6 cycles~      PROSTVAC 3 weeks after the last infusion~      Booster injections 2 weeks later and then every 3 weeks, for 6 boosters total~      Group B:~      PROSTVAC~      Booster 2 weeks later~      Docetaxel hours later~      Docetaxel and the booster every 3 weeks for 6 cycles~      Participants will have a visit 4-5 weeks after the last treatment. They will then have visits~     every 12 weeks.~      Participants will be followed for up to 15 years. This includes physical exams every year for~     5 years.~   "
70066|NCT02649842|"~     Post-Approval study to evaluate the rates of severe visual distortions for patients requiring~     correction of approximately 3.00 D to 4.75 D of corneal astigmatism.~   "
70067|NCT02649829|"~     In this multicenter phase I/II trial, dendritic cells (DCs) loaded with the~     mesothelioma-associated tumor antigen WT1 will be used in conjunction with conventional~     chemotherapy for the frontline treatment of malignant pleural mesothelioma (MPM). The general~     objective is to provide the first-in-human experimental demonstration that the combination of~     platinum/pemetrexed-based chemotherapy with WT1-targeted DC vaccination is feasible and safe~     and enables the induction of both systemic and in situ mesothelioma-specific immune responses~     in patients with MPM.~   "
70068|NCT02649816|"~     This retrospective cohort study assessed sealant clinical success applied to pit and fissure~     by dental undergraduate students at Piracicaba Dental School - Brazil.~   "
70069|NCT02649803|"~     The purpose of this study is to learn the pediatric asthma control status under community~     management model. To learn the differences of pediatric asthma control status when subjects~     assigned to community hospitals or Shanghai Childrens Medical Centre. To learn the treatment~     adherence and the frequency of asthma attack under community management model.~   "
70122|NCT02649114|"~     The combination of EDs (ED) and post-traumatic sequelae of childhood trauma leads to~     significant impairment, suffering and represents a public health concern because it is~     frequently associated with role impairment, and is frequently under-treated. Considering the~     severity of these conditions, there is a need to develop more effective treatments that are~     tailored to the specific needs of these patients as no conclusion has been made about the~     treatment of choice. To improve treatment it is critically important to study treatment~     effects and the mechanism of these effects.~   "
70070|NCT02649790|"~     This is a first-in-human, multi-center, open-label clinical study with separate dose~     escalation (Phase 1) and expansion (Phase 2) stages to assess preliminary safety,~     tolerability, and efficacy of the second generation oral XPO1 inhibitor KPT-8602 in patients~     with relapsed/refractory multiple myeloma (MM), colorectal cancer (CRC), metastatic~     castration resistant prostate cancer (mCRPC), and higher risk myelodysplastic syndrome (MDS).~      Dose escalation and dose expansion may be included for all parts of the study as determined~     by ongoing study results.~      This study is currently closed for enrollment for patients with relapsed/refractory multiple~     myeloma (MM) or colorectal cancer (CRC).~   "
70071|NCT02649777|"~     The role of oxidative stress in disease pathology is increasingly recognized. At present, the~     development of biomarkers of this state is in its infancy and the availability of clinically~     validated assays is lacking. This study will better determine normal values for specific~     biomarkers of oxidative stress. It will also investigate normal values of taurine, a natural~     occurring oxidative stress protectant. A primary and specific application of this data is for~     the evaluation of oxidative stress, levels of the natural protectant taurine, and of~     associated inflammation in the context of cystathionine β-synthase (ClinicalTrials.gov study:~     Oxidative Stress Markers in Inherited Homocystinuria and the Impact of Taurine).~   "
70072|NCT02649764|"~     The goal of this clinical research study is to study the safety of LY2606368 when given in~     combination with fludarabine and cytarabine. The effectiveness of the study drug combination~     when given to patients with relapsed or refractory AML or HRMDS will also be studied.~   "
70073|NCT02649751|"~     This is a phase II, dose ranging, multicenter, randomized, double-blind, placebo-controlled~     study.~      The aim of this study is to assess the safety of increasing doses of roscovitine administered~     orally for 4 cycles of 4 consecutive days (treatment on) separated by a 3 days treatment~     free period (treatment off) in adult CF subjects with Cystic Fibrosis carrying 2 Cystic~     Fibrosis causing mutations with at least one F508del-CFTR mutation and chronically infected~     with Pseudomonas aeruginosa.~      This study involved 36 Cystic Fibrosis patients: 24 treated and 12 controls.~   "
70074|NCT02649738|"~     This study will evaluate the outcomes of placing preserved corneal tissue within the~     keratoconic cornea in order to enhance thickness, stability, and optical conformation.~   "
70075|NCT02649725|"~     The purpose of this study is to determine whether there is positive (beneficial) impact of~     expensive cytotoxic agents on the cancer patients. It is a questionnaire based study that~     will be filled by the cancer patients without obligations.~   "
70076|NCT02649712|"~     The purpose of this study is to compare the clinical effectiveness and long-term outcomes~     between patients with malignant hilar biliary obstruction who are treated by unilateral or~     bilateral stenting.~   "
70077|NCT02649699|"~     The purpose of this pilot study is to test new magnetic resonance imaging (MRI) acquisition~     and processing techniques on primary brain tumor patients. The objectives are to improve~     image-guided radiation therapy (IGRT) planning (first part of the study) and treatment~     monitoring (second part).~   "
70078|NCT02649686|"~     The purpose of this study is to find the highest dose of durvalumab that can be tolerated~     without causing very severe side effects when receiving standard treatment and to see what~     effects the study drug has on this type of cancer.~      The researchers doing this study are also interested in looking for markers that will help~     predict which patients are most likely to be helped by durvalumab when receiving standard~     treatment and what effects durvalumab has on this type of cancer.~   "
70079|NCT02649673|"~     This trial will investigate the combination of two anti-cancer agents to treat patients with~     relapsed/refractory small cell lung cancer (SCLC) and ovarian cancers. Oral topotecan has US~     FDA approval for treating select gynecological cancers and SCLC. LCL161 is an investigational~     product that has been shown in clinical trials to work together with other anti-cancer~     agents. In this trial, investigators will determine the optimal dose of LCL161 and topotecan~     to administer to patients with relapsed/refractory SCLC and ovarian cancers, and examine the~     safety profile of the drug combination.~   "
70080|NCT02649660|"~     This study aims to evaluate whether platelets are biochemically and functionally altered in~     Fabry disease (FD) and therefore possibly implicated in FD manifestations such as~     cerebrovascular events. To test this hypothesis the investigators aim to compare platelet and~     plasma lipid profiles, as well as platelet function and coagulation parameters of FD patients~     and healthy controls.~   "
70081|NCT02649647|"~     Neoadjuvant chemoradiotherapy has been recommended as the standard preoperative treatment for~     locally advanced rectal cancer. However, preoperative radiotherapy increases the risk of~     bowel dysfunction after sphincter-preserving surgery, for which patients suffer from~     incontinence, urgency, and unpredictability defecation problems. Furthermore, preoperative~     chemoradiotherapy is a potential risk factor of anastomotic leakage and stenosis after rectal~     cancer surgery.~      Unhealthy anastomosis, with both ends of injured bowel segments after pelvic radiation, is a~     major concern. When conventional surgical procedures would retain part of sigmoid colon that~     has been included in the radiation target, sphincter-preserving surgery with proximally~     extended resection margin could provide an intact proximal colon limb for the anastomosis.~      It is not known yet whether proximally extended resection improves postoperative bowel~     function or anastomotic integrity for patients with rectal cancer after neoadjuvant~     chemoradiotherapy. The proposed study will compare sphincter-preserving surgery with and~     without proximally extended resection margin, to observe the postoperative bowel function and~     incidence of anastomotic complication. This study will examine a new surgical strategy, which~     potentially benefits the patients undergoing neoadjuvant chemoradiotherapy.~   "
70082|NCT02649634|"~     The purpose of this study is to determine whether adding motivational interviewing (MI) to a~     behavioural weight loss program (BWLP) results in improved weight loss for adults who are~     overweight or obese.~   "
70083|NCT02649621|"~     Corneal epithelial cells and limbal stem cells (LSC) are located in the limbus basal~     epithelium that are necessary for repair of corneal. About patients with deficient or absence~     of this area has been proposed various treatments such as limbal stem cell transplantation.~      This study is a prospective clinical trial to compare the improvement of limbal stem cell~     deficiency (LSCD) in vivo by using of Amniotic Membrane Extract Eye Drop (AMEED).~   "
70085|NCT02649595|"~     The aim of this study is to determine the effect of a two week respite program (Red Cross)~     for homeless people just discharged from hospitals in the capital region of Denmark.~      The study is a randomized controlled trial and an economic evaluation. The intervention is a~     2 week stay at a Red Cross respite care center. The intervention is intended for homeless~     people or functional homeless, who has been admitted to hospital and received standard~     medical care and treatment at the hospital. Under normal circumstances the homeless patients~     would be discharged to live on the street and receive care from programs in the~     municipalities. The respite center offers standard nursing care, rest with a place to sleep,~     food and help dealing with social problems such as economy and housing. The respite care~     center is led by a nurse who is represented during daytime from Monday to Friday and besides~     that, volunteers are used as staff.~      The control group is receiving usual care and is discharged to the street and the usual~     communal programs.~      The study examines whether a 2 week stay is cost effective and whether it can improve the~     health related quality of live (HRQoL). The hypothesis is that a respite care stay will~     result in a 25 % reduction in health care costs and increase the HRQoL.~   "
70086|NCT02649582|"~     In this phase I/II trial, the primary objective is to determine overall and progression-free~     survival of patients with newly diagnosed glioblastoma when autologous Wilms' tumor 1 (WT1)~     messenger (m)RNA-loaded dendritic cell (DC) vaccination is added to adjuvant temozolomide~     maintenance treatment following (sub)total resection and temozolomide-based chemoradiation.~   "
70087|NCT02649569|"~     This pilot research trial studies continuous activity monitoring during fractionated~     radiotherapy in patients with head and neck, lung, or gastrointestinal cancer. This study~     explores the use of fitness trackers to study the activity levels of patients before, during,~     and after radiation therapy and the use of weekly assessments to measure the patients'~     quality of life during radiation therapy. This may allow doctors to see if there is any~     relationship between activity levels, quality of life, treatment interruptions,~     hospitalizations, and clinical outcomes.~   "
70088|NCT02649556|"~     The objective of the ZRHR-ERS-09-EXT-US study is to further assess the effect of the Tobacco~     Heating System 2.2 (THS 2.2), a candidate Modified Risk Tobacco Product, compared to~     conventional cigarettes (CC) on the components of the smokers' health profile for a~     prolonged period of 26 weeks, providing additional information to the results of the original~     study ZRHR-ERS-09-US of 26-week exposure (NCT02396381). In total, the ZRHR-ERS-09-EXT-US~     study will extend the exposure period to 52 weeks.~   "
70089|NCT02649543|"~     The objective of the study is to compare infection rates between primary, delayed primary and~     vacuum assisted closures in contaminated and dirty/infected laparotomy wounds.~   "
70090|NCT02649530|"~     Given that up-regulation of the Wnt pathway has been identified as having a significant role~     in carcinogenesis in advanced head and neck squamous cell carcinoma, the investigator~     believes that inhibition of Porcupine via WNT974 will result in tumor control hence~     improvement in disease free and overall survival in these patients with a tolerable toxicity~     profile. As suggested by pre-clinical models, patients with a tumor harboring a Notch~     receptor (any of the four) loss of function mutation may have a greater response rate to~     treatment with WNT974. The investigator aims to address this question by administration of~     single agent WNT974 and following response radiologically along with close clinical follow up~     to monitor toxicities.~   "
70091|NCT02649517|"~     The purpose of the study is to investigate the clinical and morphological characteristics of~     chronic subclinical inflammation in the myocardium in patients with decompensated heart~     failure with ischemic systolic dysfunction.~   "
70092|NCT02649504|"~     The investigators will attempt to further increase the cure rate of ITP with medical therapy~     by providing maintenance therapy with Mycophenolate mofetil (MMF) to persistent/chronic ITP~     patients after treating them with induction therapy combining rituximab and dexamethasone.~     The investigators will randomly assign patients to MMF versus placebo in order to demonstrate~     safety (e.g., for infectious risk) and efficacy (platelet counts stably >50x109/L more than 1~     year off therapy).~   "
70093|NCT02649491|"~     Scientists have developed an instrument which works like an electronic nose. It is able to~     sniff smells and separate different smells by their electronic signature. Studies using~     an electronic nose strongly suggest that smelling samples taken from humans (e.g. urine/~     stool/ sweat/ tears) can identify different electronic smell signature from people with~     different diseases and in the future might be a new and easier way to diagnose serious~     conditions at an earlier stage.~      In a very small study, it has been successfully shown that using an electronic nose to sniff~     a stool sample does seem to identify people before they have had any radiotherapy - who will~     go on to get serious bowel side effects of radiotherapy. If this finding is correct, this is~     very important as it would allow the cancer doctors the option to change the way they give~     radiotherapy if they knew that a person was at very high risk of serious side effects from~     the treatment and to start treatment for the side effects at a much earlier stage.~      In this study the investigators want to confirm in a larger study whether the previous~     findings are correct, and to see whether similar results can be obtained by sniffing urine~     rather than stool (that would be much easier for everyone) and identify exactly which part of~     the complicated smell signature is different in the people who will get side effects. This~     may lead for the investigators to able to identify why people are making this specific smell~     and then do something about changing the smell before treatment starts. The likeliest cause~     for the production of a smell which predisposes to side effects is a specific group of germs~     living in the bowel. If these germs can be identified, then there are many possible ways of~     changing these germ populations in advance of radiotherapy.~      Enormous improvements have been made in treating cancer in recent years leading to hugely~     improved survival, however, treatment not infrequently can lead to side effects. Of all the~     possible long term physical side effects of cancer treatment, gastrointestinal (GI) symptoms~     are the most common and can have a great impact on daily activity. It is becoming~     increasingly clear that development of side effects in the bowel is not just related to the~     dose and way the radiotherapy is delivered.~   "
70094|NCT02649478|"~     A Randomized, Parallel-Group, Placebo-Controlled, Clinical Endpoint Bioequivalence Study of~     Generic Fluticasone Propionate 100 µg and Salmeterol Xinafoate 50 µg Inhalation Powder~     Compared with Advair Diskus® 100/50 in Subjects with Asthma~   "
70095|NCT02649465|"~     1. Objectives~        1. Which organ and how does SGLT2 inhibitor alter insulin sensitivity?~        2. How does SGLT2 inhibitor increase glucagon levels and hepatic glucose production?~   "
70123|NCT02649101|"~     Sixty advanced breast cancer patients are planed to enrolled in this clinical trial. Forty~     patients are enrolled into thalidomide plus chemotherapy group. Twenty patients are enrolled~     into chemotherapy alone group. There is no restriction on chemotherapy regimen and lines.~   "
70139|NCT02648893|"~     In this study, a multiple food crops basket (containing four either biofortified or~     commercially-available food crops) will be fed to young children in Mumbai, Maharashtra,~     India over a period of nine months to measure growth, cognitive changes, and immune function~     in comparison to children receiving non-biofortified crops.~      Potentially, lactating women (their mothers) will also be included in the study.~   "
70096|NCT02649452|"~     Whole body vibration (WBV) can help to improve muscle flexibility by stimulating the~     neuromuscular functions. But there is a dearth in the literature to prove its effectiveness~     in improving the flexibility of the upper limb muscles. Therefore the purpose of the study is~     to determine the effects of vibration on improving upper limb flexibility. This experimental~     research will be conducted by recruiting participants at the age of 19 to 27 with no~     histories of injuries on the upper limb. They will be randomly assigned into two groups;~     experimental (with vibration) and control (no vibration) group. The WBV machine will be used~     to provide vibration to the upper extremities by placing both palms on the vibration~     platform. The outcome measure of active chest flexibility and shoulder reach flexibility will~     be performed pre and post vibration.~   "
70097|NCT02649439|"~     Background:~      Some people who have been treated for prostate cancer still have high prostate-specific~     antigen (PSA) levels. This may indicate cancer. These people have non-metastatic castration~     sensitive prostate cancer (nmCSPC) or biochemical recurrent prostate cancer. Researchers~     think the immune system can be taught to fight and kill cancer cells. They think an~     immunotherapy vaccine called prostvac could help reduce PSA levels in people with this type~     of prostate cancer.~      Objective:~      To test if prostvac can decrease tumor growth rate as measured by PSA compared to getting~     surveillance alone.~      Eligibility:~      Men ages 18 or older who have nmCSPC or biochemical recurrent prostate cancer~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Blood and urine tests~      Bone scan~      CT scan, or MRI and PET scan: They lie in a machine that takes pictures of the body.~      Electrocardiogram: Soft electrodes are stuck to the skin to record heart signals.~      Participants will be part of 1 of 2 arms: Arm A will get prostvac for 6 months. Arm B will~     have surveillance for 6 months followed by prostvac for 6 months.~      During the prostvac period, participants will get prostvac as a shot under the skin on weeks~     1, 3, and 5, and then monthly for a total of 5 months.~      Participants will have follow-up visits at least every month until they recover from prostvac~     side effects or their cancer worsens. Visits may include repeats of screening tests.~      Participants will be followed for up to 15 years. They will have a physical exam every year~     for the first 5 years. They will have phone calls once a year.~   "
70098|NCT02649426|"~     RADIANCE-HTN is a randomized, double-blind, sham controlled, 2-cohort study (TRIO and SOLO)~     designed to demonstrate efficacy and document the safety of the Paradise Renal Denervation~     System in two distinct populations of hypertensive subjects.~   "
70099|NCT02649413|"~     The initial steroids dose for Nephrotic Syndrome is 60mg/1m2 for 6-4 weeks and the duration~     of the first steroid course is between 8 weeks to 6 months. The base of the initial dose for~     steroids Idiopathic nephrotic syndrome been put in the early 70s. In our study the~     investigators will adjusted the first steroids does to the response day. Our primary end~     point is : a lower adjusted dose is as good as the fix dose in the first year after~     diagnosis.~   "
70100|NCT02649400|"~     This study assesses the impact of diastolic heart failure on exercise capacity in women who~     have a previous coronary condition. All the participants will go through the same evaluation.~   "
70101|NCT02649387|"~     This phase II trial studies the side effects and how well ibrutinib works in treating~     patients with chronic lymphocytic leukemia who responded to initial treatment used to reduce~     a cancer (front-line therapy) but have residual disease. Ibrutinib may stop the growth of~     cancer cells by blocking some of the enzymes needed for cell growth.~   "
70102|NCT02649374|"~     The purpose of this study is to document the gut microbiome in the 1st, 2nd and 3rd trimester~     among pregnant women with gestational diabetes and non diabetic controls.~   "
70103|NCT02649361|"~     To compare the effects and safety of Anlotinib with placebo in patients with esophageal~     squamous cell carcinoma(ESCC).~   "
70104|NCT02649348|"~     A prospective randomised controlled trial to investigate effects of preoperative exercise and~     eliminating abdominal breathing on perioperative outcome in gastric cancer patients with~     metabolic syndrome who will undergoing laparoscopic gastrectomy.~   "
70105|NCT02649335|"~     Cirrhosis is the leading cause of death in India and worldwide and leading causes in~     developed world include alcoholic liver disease, hepatitis C, and more recently,~     non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH). As cirrhosis~     advances, portal hypertension develops, resulting in complications such as ascites, hepatic~     encephalopathy, and variceal hemorrhage.~      Ascites is the most common major complication of cirrhosis, occurring in 50-60% of patients~     within ten years of diagnosis . Development of ascites is an ominous landmark in disease~     progression as 15% of patients with ascites will die within 1 year, and 44% within 5 years.~     Less than 10% patients develop refractory ascites and is associated with a poor prognosis~     with a high mortality, approximately 50% within 6 months and 75% at 1 year with the median~     survival approximately 6 months . Refractory ascites occurs as a result of splanchnic~     vasodilatation and maximal activation of the sympathetic nervous system (SNS) and the renin -~     aldosterone system (RAAS) . The therapeutic options available for these patients are serial~     therapeutic paracentesis, liver transplantation and trans jugular intrahepatic portosystemic~     shunts .The model for end stage liver disease( MELD) score predicts survival in patients with~     cirrhosis . However, other factors in patients with cirrhosis and ascites are also associated~     with poor prognosis, including low mean arterial pressure; low serum sodium, low urine~     sodium, and high Child-Pugh score .~      Variceal bleed is the most dreaded complication of cirrhosis and screening endoscopic is~     recommend in these patients. About 60% of patients with decompensated cirrhosis have varices~     at the time of diagnosis. Majority of these patients will require non selective beta blockers~     (NSBB) as standard of care as primary or secondary prophylaxis in prevention of variceal~     hemorrhage. NSBB reduce portal pressure by decreasing cardiac output and by producing~     splanchnic vasoconstriction.. Endoscopic variceal band ligation (EVL) is another modality of~     treatment of esophageal varices and meta-analysis showed EVL to be associated with~     significantly lower incidence of first variceal hemorrhage without differences in mortality~     compared to NSBB. NSBB also has shown to improve survival in these patients with~     nonhemodynamic effects. Some of the patients may progress to end stage liver disease~     characterized by the development of refractory ascites and other complications.~      Most of the studies of NSBB comparing to EVL for primary/secondary prevention of variceal~     hemorrhage included patients of predominantly child A/B cirrhosis with variable number with~     ascites without any mention of ascites grading and some of trials excluded patient's with~     refractory ascites. These patients with ascites received diuretics and salt restricted diet~     as standard of care. However none of these studies mentioned about control of ascites and~     survival benefit in patients with advanced stage (child B and C) cirrhosis with ascites .In~     recent years the role of NSBB for prevention of variceal hemorrhage in refractory ascites~     patients has been questioned because of the deleterious effect on survival.However the use of~     NSBB in end stage liver disease has shown mixed results and controversial.~      Therefore this study is being planned to know the effects of NSBB in advanced stage liver~     disease patients with ascites and varices in preventing variceal hemorrhage ,effect on~     ascites and survival.~   "
70106|NCT02649322|"~     Purpose of this study is to investigate the pain outcomes and satisfaction of pain relief for~     pediatric patients receiving needleless jet-injected (J-Tip) lidocaine prior to regional~     anesthesia with femoral and/or sciatic nerve block and general anesthesia for arthroscopic~     knee surgery compared to femoral nerve block and/or sciatic nerve block with needle injected~     lidocaine prior to regional and general anesthesia.~   "
70107|NCT02649309|"~     This trial is a 2 x 2 factorial design, double-blinded, randomized controlled trial to~     evaluate efficacy and safety of remote ischemic preconditioning and postconditioning in~     patient undergoing coronary angioplasty.~   "
70108|NCT02649296|"~     The purpose is to find out the effect of Skanlab at knee arthrosis.~   "
70109|NCT02649283|"~     This is a Phase IV, multicenter, open label, non-randomized comparative group study to assess~     the safety and performance of the OrbiSymm system in subjects referred to contra lateral~     breast symmetrization involving a breast reduction following breast reconstruction~     post-mastectomy.~   "
70110|NCT02649270|"~     The humanized recombinant anti-CD6 monoclonal antibody Injection (T1h) has been approved for~     psoriasis in India. The first trial in China is to evaluate the tolerability, safety,~     pharmacodynamic, pharmacokinetics and preliminary efficacy of T1h for patients with~     psoriasis.~   "
70111|NCT02649257|"~     The purpose of this study is to observe the axial IOL rotation after surgery with a capsular~     tension ring (CTR) and a MC6125 AS IOL.~      At the end of surgery the orientation of the IOL is documented with a short video clip via~     the operating microscope unit. Follow-up examinations are performed 1 hour, 1 week and 6~     months after surgery. Rotational stability of the IOL is assessed using retroillumination~     images with a method to avoid bias from cyclorotation or head tilt.~   "
70136|NCT02648932|"~     The study seeks to compare time from formal search to hematopoietic cell transplantation~     (HCT) for patients 18 years and older, randomized between haplo-cord search and matched~     unrelated donor (MUD) search for patients with acute myeloid leukemia (AML) and high-risk~     myelodysplastic syndrome (MDS)~   "
70137|NCT02648919|"~     The purpose of this study is to evaluate the effects of Noni extract in men diagnosed with~     very low risk or low risk prostate cancer~   "
70112|NCT02649244|"~     The purpose of this study is to examine the effectiveness of the Family Caregiver Training~     Program for caregivers of people with dementia, using a pretest posttest randomized control~     trial with 3-month follow-up. The Family Caregiver Training Program will consist of 3-hours~     and hence, three modules over the course of one day. Module one will present information on~     communication, eating, and nutrition, module two will focus on transfers and toileting, and~     module three will focus on bathing, grooming, and dressing. The control group will receive~     standard care as relevant to dementia family caregivers including general information on the~     progression of dementia, and helpful resources as suggested by the Alzheimer's Association. A~     convenience sample of 36 family caregivers will be recruited by flyers posted throughout~     local area community boards and Alzheimer's Association media outlets. A repeated measures~     ANOVA will be used to assess the group differences in knowledge and confidence at three time~     points (pre-intervention, post-intervention, and 3-months post-intervention). Changes in~     caregiver burden, depression, quality of life, and occupational performance and satisfaction~     will be assessed 3-months post-intervention.~   "
70113|NCT02649231|"~     96 recently detoxified alcoholics will be randomized to receive either 3 sessions ketamine~     (0.8 mg/kg IV over 45 minutes) or placebo plus manualised psychological therapy, or 3~     sessions of ketamine or placebo plus simple psychoeducation. Patients will be assessed at 3~     and 6 months on a range of psychological and biological variables. Primary endpoints will be~     % days abstinent at 3 and 6 months and relapse rates at 6 months. Secondary endpoints include~     depressive symptoms, craving, quality of life.~   "
70114|NCT02649218|"~     A safety extension study to evaluate the long-term safety of QGE031 240 mg s.c. given every 4~     weeks for 52 weeks in Chronic Spontaneous Urticaria patients who completed study CQGE031C2201~   "
70115|NCT02649205|"~     The purpose of this study is to characterise the patient and disease profile under the~     influence of a protein-restricted diet supplemented with keto acids/amino acids (KA/AA),~     focusing on the progression of chronic renal insufficiency, calcium and phosphorus~     metabolism, nutritional status, patient compliance to diet and Ketosteril intake as well as~     the persistent dietary education to ensure compliance in a large group of pre-dialysis~     patients.~   "
70116|NCT02649192|"~     Children are particularly vulnerable to respiratory virus infections, especially influenza.~     Vitamin A & D deficiencies are associated with vulnerability to infectious diseases of the~     respiratory tract. The central hypothesis of this protocol is that vitamin supplements will~     enhance antibody responses toward the flu vaccine in children. Children, 2-8 years old, will~     be randomized to receive influenza virus vaccine with a vitamin A+D supplement or influenza~     virus vaccine with placebo. Children will be tested for vitamin levels and immune responses~     before and after influenza virus vaccinations to determine if vitamin supplementation~     improves the influenza virus vaccine-induced immune response.~      PRIMARY OBJECTIVE:~        -  To assess the vaccine-induced and total antibody (including IgG and IgA) response after~          influenza virus vaccine administration and IgA/IgG plus IgA/IgM ratios at 28 and 56 days~          in sera~      SECONDARY OBJECTIVE:~        -  To assess the neutralizing response toward influenza virus vaccine in the sera.~   "
70117|NCT02649179|"~     The purpose of this study is to evaluate the effect of pain relief after infusion of~     ropivacaine at port sites at end of laparoscopic cholecystectomy (LC)compared with placebo~     (0.9% normal saline).~   "
70118|NCT02649166|"~     Essential tremor is an incurable, degenerative brain disorder that results in increasingly~     debilitating tremor, and afflicts an estimated 7 million people in the US. In one study, 25%~     of essential tremor patients were forced to change jobs or take early retirement because of~     tremor. Essential tremor is directly linked to progressive functional impairment, social~     embarrassment, and even depression. The tremor associated with essential tremor is typically~     slow, involves the hands (and sometimes the head and voice), worsens with intentional~     movements, and is insidiously progressive over many years. Deep brain stimulation has emerged~     as a highly effective treatment for intractable, debilitating essential tremor. However,~     since the intention tremor of essential tremor is typically intermittent, and commonly absent~     at rest, the currently available continuous deep brain stimulation may be delivering~     unnecessary current to the brain that increases undesirable side effects such as slurred~     speech and walking difficulty, and hastens the depletion of device batteries, necessitating~     more frequent surgical procedures to replace spent pulse generators. The overall objective of~     this early feasibility study is to provide preliminary data on the safety and efficacy of~     closed-loop deep brain stimulation for intention tremor using novel deep brain stimulation~     devices capable of continuously sensing brain activity and delivering therapeutic stimulation~     only when necessary to suppress tremor.~   "
70119|NCT02649153|"~     Every patient undergoing surgery in the abdomen, such as hepatic resection, will experience~     temporary paralysis of bowel function. This study aims to evaluate whether smoked plum and~     chewing gum can reduce the bowel paralysis after hepatic resection in patients with~     hepatocellular carcinoma. One third of the study population will receive smoked plum, one~     third with chewing gum, and the last will act as empty control.~   "
70120|NCT02649140|"~     Purpose:~      The aim of this present study is to investigate the effect of vinegar consumption on 24-hour~     urinary risk factors associated with calcium oxalate urinary stone formation and blood~     biochemical parameters.~      Methods:~      The investigators will recruit 50 healthy young student volunteers in this study. By simple~     random sampling technique, volunteers will be allocated to two groups (group 1, control~     group; group 2, vinegar group).Each participant in vinegar group drink 15ml vinegar (~     Ninghuafu, Sanxi, China) at noon and evening respectively for a period of four weeks.The end~     point of this study is comparison the outcomes of 24-hour urine and blood biochemical~     parameters between different group and point-in-time.~   "
70121|NCT02649127|"~     This is an 8-week experimental, repeated-measures clinical trial randomizing 120 Service~     Members with symptoms of PTSD into one of four groups: 1) imaginal exercises of exposure~     therapy only, 2) aerobic exercise only, 3) imaginal exercises augmented with aerobic~     exercise, or 4) self-care.~   "
70138|NCT02648906|"~     The purpose of this study is to evaluate efficacy and safety of Choline alfoscerate and~     Donepezil for cognitive improvements of patients with cerebrovascular injury in Alzheimer~     patients~   "
84669|NCT02458781|"~     This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy of~     ciprofloxacin versus metronidazole versus placebo in eradication of small intestinal~     bacterial overgrowth (SIBO).~   "
70124|NCT02649088|"~     Prospective observational study designed to implement a daily monitoring of microcirculation~     and tissue oxygenation in all critically ill patients admitted to the ICU in the period of~     nine months, in order to assess the prevalence of microvascular perfusion abnormalities and~     their relation to: outcomes, underlying disease, hospital stay, clinical-laboratory and~     hemodynamic parameters commonly measured, indices of clinical severity and predictors of~     mortality , therapeutic interventions that are part of routine clinical practice (fluids,~     sedation, vasopressors, inotropes, anticoagulants, renal replacement therapy, blood~     transfusion). The study also includes the evaluation of sublingual microcirculation and~     tissue oxygenation in 30 healthy volunteers to compare normal and pathological conditions.~     Within the first 12 hours after admission to ICU and every 24 hours for the duration of~     hospitalization, the following evaluations will be made: -study of sublingual~     microcirculation using sidestream dark field (SDF) imaging, muscle tissue oxygenation using~     near infrared spectroscopy (NIRS). The data will be analyzed to test correlation between the~     outcome of patients admitted in ICU and microcirculatory parameters.~   "
70125|NCT02649075|"~     The objective of this study is to evaluate the nutritional therapy with SBI (a medical food)~     as compared to placebo in the clinical dietary management of mild to moderate Crohn's~     disease.~   "
70126|NCT02649062|"~     The purpose of this study is to determine the effect of NGM282 on colonic transit, bile acid~     homeostasis, and fecal fat in subjects with functional constipation and healthy individuals.~   "
70127|NCT02649049|"~     Patients with NAFLD and matched controls will be asked about their demographic status, and~     their previous year dietary intakes using a validated FFQ.~   "
70128|NCT02649036|"~     Background:~      Inequality in access to healthcare is a challenge internationally. Despite that medical~     emergency calls can be considered as access point to pre-hospital emergency care and hospital~     admission in emergency situations, no data on inequality in access to healthcare through~     emergency calls is reported in the international literature.~      Study aims:~      The aim of this study is two-fold:~        1. to evaluate the association between socio-economic characteristics of citizens and~          first-time emergency call in the Capital Region of Denmark~        2. to evaluate the association between socio-economic characteristics of citizens with an~          emergency call and the priority level of the response provided by the emergency medical~          dispatch center in the Capital Region of Denmark.~      Method: Observational register based study of adult citizens in the Capital Region of~     Denmark. Educational level, household income and employment are used as socioeconomic~     indicators. The unique civil registration number will be used to link data from the Emergency~     Medical Dispatch Center with data from the Civil Registration System, Danish registers on~     personal labor market affiliation, the Danish Populations Education Register, the Danish~     Income Statistics Registry and the national patient registry. Logistic regression models will~     be used for the association between socio economic indicators and first time emergency calls~     and the association between socioeconomic indicators and the priority level of the response~     provided.~   "
70129|NCT02649023|"~     To investigate the incidence of pre- and early postoperative deep venous thrombosis in~     patients undergoing hepatobiliopancreatic surgery, as well as potential corresponding risk~     factors with special attention to circulating tumor cells.~   "
70130|NCT02649010|"~     The purpose of this study is to support the use of the Enlite 3 sensor in arm and thigh in~     subjects age 14 - 75 years and provide additional characterization of the Enlite 3 sensor~     performance in arm in subjects age 14 - 75 years.~   "
70131|NCT02648997|"~     This research study is studying a targeted immunotherapy as a possible treatment for~     Recurrent Meningioma. The name of the study intervention involved in this study is Nivolumab.~   "
70132|NCT02648984|"~     Pulmonary arterial hypertension (PAH) in patients with congenital heart disease usually~     develops secondary to chronic volume overload of the pulmonary circulation following left to~     right shunt. This overload leads to elevated pulmonary artery pressure (PAP) and later to~     increased pulmonary vascular resistance (PVR), leading to right ventricular dysfunction,~     considerable morbidity and even mortality.~      Since PAH nowadays is mostly detected when symptoms occur and PAP are elevated, the disease~     already evolved to an advanced stage and treatment is often initiated too late. Our research~     group standardized the technique for the detection of early pulmonary vascular disease by~     bicycle stress echocardiography. The investigators now aim to assess this exercise technique~     in a group of patients with ventricular septal defect.~   "
70133|NCT02648971|"~     This randomized, controlled clinical trial will compare the outcomes of single portal versus~     two portal techniques in patients who have meniscus or articular cartilage pathology. The~     study hypothesis is that patients who undergo single portal arthroscopy will have less pain~     post-operatively, use less pain medication, and have a higher International Knee~     Documentation Committee (IKDC) score at six months and one year compared to patients who~     undergo traditional two portal knee arthroscopy.~   "
70134|NCT02648958|"~     Ischemia reperfusion injury causes the release of free oxygen radicals. The selective~     alpha2-receptor agonist, dexmedetomidine, has an inhibitory effect on inflammatory responses~     during ischemic injury. The aim of this study is to evaluate the effect of dexmedetomidine on~     inflammatory responses during ischemia-reperfusion injury in skeletal muscle.~   "
70135|NCT02648945|"~     Anxiety levels among the younger generation especially students have been increasing~     drastically in recent years. This severely affects a student's academics as previous studies~     have shown a strong correlation between high anxiety levels and poor working memory. Working~     memory, also known as short term memory is an important component in studying as it aids in~     holding important information needed to understand following information for a short period~     of time. This concerning phenomenon has drawn the attention of researchers to find solutions~     to this issue where recent studies have found physical exercise to contribute in the~     improvement of cognition which also includes working memory. Hence, the aim of this study is~     to compare the effects of low and high intensity exercises on working memory among students~     with high anxiety levels. Thirty female undergraduate students from UTAR with relatively high~     levels of anxiety will be conveniently sampled using Beck Anxiety Inventory. Participants~     will then be randomly allocated into 2 groups to undergo low and high intensity exercise on a~     treadmill according to Balke's Protocol. 2 memory assessments involving Verbal Memory Task~     will be conducted for each participant before and after the intervention.~   "
70140|NCT02648880|"~     The purpose of this study is to investigate the effects of a preoperative exercise program in~     patients with pancreatic cancer preparing for surgery. Preoperative exercise programs have~     been shown to be effective in other cancer populations, but have not been investigated in~     patients with pancreatic cancer. The outcomes in this study will be changes in physical~     fitness, function, and postoperative outcomes. This investigation is a non-randomized control~     trial, with participants assigned to receive the preoperative exercise intervention in~     addition to standard care, or standard care alone if unable to commit to an exercise program~     for practical reasons. Possible mediators for the effects of exercise on postoperative~     outcomes will also be assessed, including psychological outcomes and markers of systemic~     inflammation. These measures will be assessed in all participants prior to program~     initiation, prior to surgery, and after surgery. Changes in these measures in response to~     exercise will be assessed, as well as the ability of the preoperative measures to predict~     postoperative outcomes.~   "
70141|NCT02648867|"~     This study will assess the ability for continuous electronic feedback to reduce the length of~     second stage labor and improve maternal and fetal outcomes.~   "
70142|NCT02648854|"~     This study is A randomized, open-label, single dose, 2-way crossover study to investigate the~     effect of food on the pharmacokinetic characteristics of CKD-395 in healthy male volunteers.~   "
70143|NCT02648841|"~     The purpose of this study is to explore the role of adjuvant chemo-radiotherapy in patients~     with local advanced gastric cancer.~   "
70144|NCT02648828|"~     The purpose of the study is to compare the ability of physicians and a statistical index (the~     Rothman score) to predict clinical deterioration over the next 24 hours. Clinical~     deterioration is defined as concern in change in vital signs or patient status requiring a~     call to the rapid response team, cardiopulmonary arrest, or transfer to the ICU.~   "
70145|NCT02648815|"~     This study aims to investigate the natural clinical course, diagnostic possibilities and~     treatment modalities in moderately severe (MSAP) and severe acute pancreatitis (SAP). The~     management of severe acute pancreatitis varies with the severity and depends on the type of~     complication that requires treatment. Although no universally accepted treatment algorithm~     exists, the step-up approach using close monitoring, percutaneous or endoscopic drainage,~     followed by minimally invasive video-assisted retroperitoneal debridement has demonstrated to~     produce superior outcomes to traditional open necrosectomy and may be considered as the~     reference standard intervention for this disorder.~   "
70146|NCT02648802|"~     This randomized controlled trial is to evaluate the impact of additional cavity shaving (CS)~     on pathological cavity margin (CM) status in breast cancer patients. Patients receiving~     standard breast-conserving surgery (BCS) will be randomized to intra-operative CM assessment~     versus intra-operative CS followed by CM assessment. The primary objective of this study is~     to assess the impact of CS on intra-operative CM status, intra-operative re-excision rate,~     post-operative CM status and re-excision rate, cosmetic outcomes, and on intraoperative time~     and medical costs.~   "
70147|NCT02648789|"~     The purpose of this study is to investigate the correlation between DNA methylation and the~     treatment and recurrence of oral cancer.~   "
70148|NCT02648776|"~     The aims of this study are to (1) examine the medication use patterns of commonly prescribed~     hypnotics and the factors that were associated with the long-term and short-term use patterns~     among the elderly population in Taiwan; (2)investigate the associations of using hypnotics~     with the elderly patients' disease statuses, efficacy and safety, as well as its~     pharmacokinetic and pharmacogenetic characteristics;(3) determine the clinical, economic and~     humanistic outcomes of using hypnotics and the corresponding contributing factors for the~     elderly in Taiwan.~   "
70149|NCT02648763|"~     The purpose of this study is to evaluate the accuracy of participants imaging versus staging~     procedures. The investigators will consent subjects that are scheduled to undergo staging~     procedures to diagnose malignant pleural mesothelioma (including pleuroscopy, bronchoscopy,~     endobronchial ultrasound and laparoscopy) as part of their standard of care.~   "
70150|NCT02648750|"~     This feasibility study evaluates whether it is possible to run a larger scale study to~     investigate the use of a self-management programme with adults who have recently had a~     stroke. Half of the participants will receive support with self-management from stroke~     therapists, while the other half will receive it from rehabilitation assistants.~   "
70151|NCT02648737|"~     Anxiety disorders occur in up to 35% of patients with Parkinson's disease (PD) and have a~     negative effect on gait, dyskinesia, freezing, on/off fluctuations, and quality of life. With~     this Randomized Controlled Trial the investigators intend to 1) develop a Cognitive~     Behavioural Therapy (CBT) module for anxiety in PD 2) assess the effectiveness of this module~     in reducing anxiety symptoms, and 3) study the effects of CBT on cerebral connectivity.~     Effective CBT treatment of anxiety will provide patients with behavioural and anxiety~     management techniques that can give lasting benefits, not only on anxiety symptoms, but~     potentially also on motor symptoms.~   "
70152|NCT02648724|"~     This is the first study to test Sym015 in humans. The primary purpose of this study is to see~     if Sym015 is safe and effective for patients with advanced solid tumors who do not have other~     available or accessible treatment options.~   "
70153|NCT02648711|"~     The purpose of this study is to determine the maximum tolerated dose (MTD) and/or recommended~     Phase 2 dose (RP2D) of weekly dosing of CRLX101 (both as monotherapy; (Schedule 1) and in~     combination with bevacizumab every 2 weeks (Schedule 2) and weekly with a 3 week on / 1 week~     off schedule in combination with mFOLFOX6 (Schedule 3) to affirm the dose for future clinical~     studies.~   "
70154|NCT02648698|"~     82 cases with a diagnosis of chronic endometritis, confirmed by the presence of plasma cells~     in endometrial biopsy sample identified by immunohistochemical staining using CD138 antibody,~     will be recruited. The subjects will be randomly divided into two groups, the experimental~     group will be given antibiotic (Augmentin) treatment, the control group will be given~     placebo. A repeat endometrial biopsy sample will be obtained one month after completion of~     the antibiotic therapy to assess the response to treatment. The cure rate will be compared~     between the two groups~   "
70198|NCT02648126|"~     The purpose of this study is to determine occurrence of pure red cell aplasia in a group of~     participants with chronic renal insufficiency and with resistance criteria to epoetin alfa~     treatment.The investigational product is producted by Bio-Manguinhos / Fiocruz (BIO-EPO) and~     it is provided by the Unified Health System.~   "
70155|NCT02648685|"~     There was no any China mainland data showing the contribution of BBG and PBG to HbA1c in T2DM~     patients treated with OADs using the CGM method. Therefore this study is aimed to investigate~     the contribution of BBG and PBG to HbA1c in Chinese T2DM patients treated with OADs using~     CGMS. It's expected to generate evidence to support the concept of individualized therapy~     when patients are uncontrolled by OADs.~   "
70156|NCT02648672|"~     This is a randomized double-blind (investigator and subject blinded), placebo controlled~     ascending single dose study to evaluate the safety, tolerability, and pharmacokinetic profile~     of BPN14770 in healthy male and female subjects. Each subject will be randomized to receive~     either a single dose of BPN14770 or placebo.~   "
70157|NCT02648659|"~     This study assessed the effect of tailored eradication therapy according to Clarithromycin~     resistance in Helicobacter pylori patients.~   "
70158|NCT02648646|"~     Purpose: To report the feasibility and to obtain preliminary data on the effects of using an~     enhanced Otago Exercise Programme to reduce fall risk in individuals with osteoarthritis~     (OA).~      Participants: Ten participants from the Johnston County Osteoarthritis Project who have OA,~     are at risk for falls, and are 65+ years old.~      Procedures (methods): All participants will receive the 6-month enhanced Otago program. The~     investigators will assemble data: quantifying participant adherence to and safety of the~     intervention, ascertaining retention of participants for 6 months, determining acceptability~     of the program, and other validated measures (e.g., number of falls and fall severity,~     balance measures).~   "
70159|NCT02648633|"~     The purpose of this study is to evaluate the safety and feasibility of the immunotherapeutic~     agent nivolumab given in combination with gamma knife therapy and valproate in patients with~     recurrent glioblastoma, a common and lethal type of brain cancer.~   "
70160|NCT02648620|"~     PREVEIL is a prospective, multi-center, single-arm clinical trial to assess the safety and~     functionality of the SurModics drug coated balloon (DCB) in the treatment of subjects with~     symptomatic peripheral artery disease (PAD) due to de novo stenoses of the femoral and~     popliteal arteries. The trial will enroll up to 15 subjects.~   "
70161|NCT02648607|"~     Pelvic Girdle Pain (PGP) during pregnancy occurs in approximately 70% of females and 38% of~     women continue to suffer PGP symptoms beyond 12 weeks following delivery. PGP post- partum~     causes pain during everyday activities that impacts negatively on health related quality of~     life and is associated with significant healthcare and societal costs. These women are often~     referred to physiotherapy, however management is difficult and there is a weak evidence base~     for its management.~      Alongside the provision of advice and information, physiotherapists commonly prescribe~     orthoses such as a rigid belt with the aim of optimising pelvic stability and reducing pain.~     More recently a novel customised Dynamic Elastomeric Fabric Orthosis has been developed as an~     alternative to an 'off the shelf' pelvic belt. No studies have investigated their~     effectiveness in complementing standard physiotherapy advice and management.~      The investigators will undertake a comprehensive systematic review of the literature to~     critically evaluate the evidence base for the conservative management of chronic post-partum~     PGP. This will inform a single case experimental design. Here eight AB single case studies~     will be performed with the point of intervention being randomised between subjects. The use~     of a randomisation test permits subsequent statistical analyses of group effects.~     Participants' pain, activity levels, and quality of life will be evaluated along with~     subjective changes in confidence and urinary incontinence. Adherence to orthosis use will be~     diarised. Exit interviews will assess aspects such as the appropriateness of the outcome~     measures and acceptability of the intervention that will help to inform future clinical~     trials.~   "
70162|NCT02648594|"~     When patient presents a lung node, there is an important risk that this node was a tumor. For~     patients who have these nodes, the surgery is the best treatment. When the surgery is~     possible, the thoracoscopy may be more advantageous compared to thoracothomy (decrease of~     post surgery pains, decrease of recovery time and decrease of drugs consumption).~     Nevertheless, thoracoscopy needs specific materiels and nécessite un équipement spécifique~     and trained physicians.~      Moreover, this technic needs that nodes was well localized. For this, radiologists use~     CT-guided hook wire localization of these lung nodes before surgery.~      TThe hook wire laying is delicate. It can lead secondaries effects as pneumothorax,~     dislodgement of the hook wire before and after surgery. The success rate of hook wire~     fixation in lung near of the node is primary.~      The main objective of our study is to assess the success rate localization of node in surgery~     piece, that is to verify if the hook wire have allowed to localize the lung node in surgery~     piece.~   "
70163|NCT02648581|"~     The purpose of this study is to evaluate the proof of concept of efficacy of ustekinumab in~     subjects with Behçet disease, including patients with oral ulcers (STELABEC-1) and patients~     with active posterior uveitis or panuveitis (STELABEC-2)~   "
70164|NCT02648568|"~     The aim of the study is to compare the benefit of two cognitive therapies in severe~     sleepwalking/ sleep terrors: relaxation vs. relaxation plus hypnosis. This is a monocentric,~     double-blind controlled study. 75 patients (aged more than 15 yo) with severe sleepwalking~     (defined as at least one epsidoe per week and at least two awakenings in stage N3 on video~     polysomngraphy) will be included. All patients will have a visit 1 for diagnosis including a~     medical interview, a video polysomnography, questionnaires on sleepwalking (PADSS and~     systematized interview), sleep quality (PSQI, MEQ) and sleepiness (Epworth scale) and~     suggestibility scale. 25 patients will be randomized to the relaxation group, 25 patients to~     the hypnosis plus relaxation group, while the 25 non-randomized patients will be non-treated~     controls. Randomized patients will receive the therapy on day 1, and be monitored during the~     subsequent night. They will have a weekly therapy for 4 additional sessions and be monitored~     again on Month 1, as well as they will complete the sleep and sleepwalking questionnaires.~     They will also complete the questionnaire by phone on Month 3. The non-randomized controls~     will complete the questionnaire on month 1, with no therapeutical intervention between Day 1~     and Month 1. The main outcome will be the frequency of sleepwalking episodes, as assessed by~     the PADSS-B. Secondary outcomes include the changes in other subitems of teh PADSS, of the N3~     awakenings in v-PSG between night 1 and Night 2 (short term effect) and Night 1 and Night 28~     (long term effect), as well as changes in sleep quality and sleepiness scales. A comparison~     of spectral EEG, as well as respiration, eye movements, muscle tone and heart rate during~     rest, hypnosis trance, relaxation and sleepwalking episodes is also scheduled.~   "
70165|NCT02648555|"~     Embryo adhesion and placentation depend on tissue plasminogen activator (tPA)-mediated~     activation of brain-derived neurotrophic factor, vascular endothelial growth factor and other~     growth factors, formation of hemidesmosomes, and degradation of extracellular matrix and~     basement membrane, either directly or by activating matrix metalloproteinases.~      Since glucose and insulin stimulate release of a major tPA inhibitor by endothelial cells -~     plasminogen activator inhibitor (PAI)-1 - the investigators hypothesized that lifestyle~     interventions proven effective in maintaining glucose and insulin levels within the normal~     range would increase the take home baby rate in women undergoing assisted reproduction.~   "
70166|NCT02648542|"~     This study evaluates the ability of compensatory auditory stimulation (CAS) and transcranial~     direct current stimulation (tDCS) to help alleviate tinnitus. Subjects will receive CAS,~     tDCS, and the combination of the two to assess the effectiveness of the treatment.~   "
70167|NCT02648529|"~     This project intends to investigate children with idiopathic and cryptogenic localization~     related epilepsies, using a longitudinal assessment of structural and functional MRI data, in~     relation to neuropsychological evaluation. The rationale is primarily based on: 1) the~     frequent observation of selective cognitive dysfunctions in such children, the~     pathophysiology of which remains largely uncertain; 2) the recent major advances in the MRI~     investigation of brain maturation showing striking age and region dependant patterns.~      The primary hypothesis is that some children with localization related epilepsies suffer from~     altered maturation in the epileptic brain regions, and that this abnormal maturation affects~     their cognitive abilities. 100 children with localization related epilepsies and 100 matched~     controls will be prospectively enrolled during the first two years of the disease (for~     patients) and benefit from a comprehensive phenotypic and neuropsychological evaluation once~     a year for 5 years. The brain maturation of these children will be longitudinally assessed~     using structural and functional MRI, and correlated with neuropsychological data.~     Investigators hope to demonstrate that children with localization related epilepsies and~     cognitive dysfunctions suffer from an abnormal brain maturation in regions underlying the~     epileptic activity and the altered cognitive processes. The finding could partly bridge the~     gap between these two abnormalities and help better understand their interaction and~     respective dynamic. Once validated, the study of regional brain maturation in children with~     epilepsy might be further used as a reliable surrogate marker or predictor of associated~     cognitive dysfunction.~   "
70168|NCT02648516|"~     Combination antiretroviral therapy (ART) effectively suppresses viral replication, leading to~     a significant immune recovery and a dramatic reduction in the incidence of AIDS-defining~     events. However, approximately 20% of individuals who exhibit stable viral suppression by~     ART, but fail to achieve sufficient immune reconstitution and are considered immune~     nonresponders (INRs). These INRs often experience an increased risk of opportunistic~     infections and shorter life expectancy compared with matched immune responders.Therefore,~     efficiently treating these immune nonresponders has become one of the most difficult~     challenges in the clinic.~   "
70169|NCT02648503|"~     Single center, prospective, randomized, single blinded, parallel group and controlled,~     assessor-blinded trial to compare the impact of Deep neuromuscular block and Sugammadex~     versus Standard of care on Quality of recovery in patient undergo elective laparoscopic~     cholecystectomy using PQRS at different time-point: 15 minutes (T15), 40 minutes (T40),~     one(D1) and three(D3) days after surgery~   "
70170|NCT02648490|"~     This study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose~     (RP2D) of humanized anti-EGFR monoclonal antibody, HLX07, in patients with epithelial cancer~     who have failed standard therapy and deemed unamenable by conventional therapy. This study~     will also evaluate the pharmacokinetics, pharmacodynamics, immunogenicity and anti-tumor~     effect of HLX07 and explore the potential prognostic and predictive biomarkers.~   "
70171|NCT02648477|"~     This phase II trial studies how well pembrolizumab and doxorubicin hydrochloride works~     compared to pembrolizumab with anti-estrogen therapy (anastrozole, letrozole, or exemestane)~     in treating patients with triple-negative or hormone-receptor positive breast cancer that has~     spread from the primary site (place where it started) to other places in the body.~     Pembrolizumab is an antibody drug that blocks a molecule called programmed death (PD)-1. PD-1~     is a molecule that shuts down the body's immune responses and prevents the immune system from~     attacking the cancer. Doxorubicin hydrochloride is a drug used in chemotherapy that works to~     stop the growth of tumor cells by stopping them from dividing and by causing them to die.~     Anti-estrogen therapy, including anastrozole, letrozole, and exemestane, lowers estrogen~     levels in the body, which may help treat cancer that is hormone receptor-positive. Giving~     pembrolizumab together with standard treatment of either doxorubicin hydrochloride~     (triple-negative cancer) or anti-estrogen therapy (hormone receptor-positive cancer) may be~     an effective treatment for these types of breast cancer.~   "
70172|NCT02648464|"~     This safety pilot study evaluates the effect of hydroxychloroquine on preventing recurrent~     cardiovascular events among myocardial infarction patients. Half of the participants will~     receive hydroxychloroquine, whereas the other half will receive placebo during six months.~   "
70173|NCT02648451|"~     -  To evaluate tolerance and acceptability of AYMES ROME in patients requiring~          supplementary oral nutritional support compared with currently available alternatives.~        -  To obtain data to support a submission to Advisory Committee on Borderline Substances~          (ACBS) for AYMES ROME (to allow for prescription in the community at National Health~          Service (NHS) expense).~   "
70174|NCT02648438|"~     This is an open-label,partially randomized, four-period study in healthy male subjects to~     assess the bioavailability and pharmacokinetics of a single dose of AZD7594 when administered~     intravenously, orally and inhaled via two different dry powder inhalers (DPIs) and a~     pressurized meter-dose inhaler (pMDI)~   "
70175|NCT02648425|"~     This is a phase IB study to assess the safety and tolerability of ASLAN001 when given in~     combination with either Cisplatin and 5-Fluorouracil or Cisplatin and Capecitabine, with a~     view to identifying the recommended Phase II dose.~   "
70243|NCT02647541|"~     The hypothesis of this study is a nutrition preoperatively in infants and children undergoing~     elective cardiac surgery with cardiopulmonary bypass leads to improvement in nutritional~     status, intervention, and that this results in good postoperative results.~   "
70244|NCT02647528|"~     A Randomized, Blinded, Single-Centered, Placebo-Controlled Trial of Pulse Dyed Laser~     (Chromogenex Regenlite Transform) in the Treatment of Inflammatory Acne Vulgaris~   "
70176|NCT02648412|"~     The aim of the study was to describe the relationship between the intensity of a standardized~     tetanic stimulation and the associated reflex pupillary dilation in patients under ketamine~     sedation.~      After an intravenous bolus of 1 mg/kg of ketamine, tetanic stimulations were performed every~     minute at increasing intensities of 10, 20, 30, 40 and 60 milliamps (similar to the~     stimulations of neuromuscular blocking agents monitoring). Pupillary diameter was measured~     before and after each stimulation.~   "
70177|NCT02648399|"~     This study recruit the patients with unilateral papillary thyroid cancer before operation,the~     patients agree to enter the test,and divided into experimental and control group.experimental~     group patients receive the surgery including unilateral thyroid lobectomy and bilateral~     central lymph node dissection.and control group receive the surgery including unilateral~     thyroid lobectomy and unilateral central lymph node dissection.last the investigators compare~     numbers of patient with tumor recurrence and metastasis rate of 5 years,numbers of metastatic~     lymph node,and numbers of participants with adverse events related to treatment between two~     groups in order to evaluate the significance of bilateral lymph node dissection.~   "
70178|NCT02648386|"~     Erectile dysfunction (ED) is one of the commonest complications in men after rectal cancer~     treatment. The purpose of this study is to assess the safety and efficacy of autologous bone~     marrow mononuclear cells (BMMCs) or allogeneic human umbilical cord-derived mesenchymal stem~     cells (HUC-MSCs) combined with NeuroRegen scaffold transplantation in men with erectile~     dysfunction after rectal cancer treatment.~   "
70179|NCT02648373|"~     The purpose of this study is to evaluate patients with low back pain who are scheduled to~     begin physical therapy but have not yet had their first appointment to better understand~     their beliefs and attitudes and to evaluate the effects of an educational session about low~     back pain.~   "
70180|NCT02648360|"~     Hispanics share a disproportionate burden of several of the nation's leading chronic diseases~     caused by poor lifestyle habits such as sedentary behavior and poor quality nutrition intake.~     This project will design, implement and evaluate the delivery and effectiveness of an~     existing health promotion text messaging program focused on increasing physical activity and~     improving dietary behaviors among medically underserved Hispanic patients. Adult Hispanic~     patients referred by their healthcare provider at a local free community health clinic will~     be invited to participate in the 4-month long study. Patients who agree to participate will~     be sent health promotion text messages and will complete a brief pre-post assessment battery.~     Patients who do not send an initial enrollment text (to agree to participate) will receive a~     follow up telephone call from the research team to encourage participation. Evaluations will~     consist of: (1) physician referral rates; (2) patient enrollment rates; (3) demographic~     differences (gender, age) in participants/non-participants; and (4) pre-post changes in~     levels of physical activity and quality dietary intake will be conducted. The results of this~     study will provide a better understanding of the feasibility and effectiveness of~     implementing referral-based text messaging programs among medically underserved Hispanic~     patients at high risk for chronic diseases.~   "
70181|NCT02648347|"~     A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction of~     anemia and maintenance of hemoglobin (Hb) in subjects with NDD-CKD~   "
70182|NCT02648334|"~     This study evaluates the safety and effectiveness Percutaneous Transluminal Angioplasty(PTA)~     using Drug-Coated Balloons for the treatment of Superficial Femoral and popliteal peripheral~     Artery disease.~   "
70183|NCT02648321|"~     The purpose of this study is to determine whether motivational intervention is effective in~     promoting exercise habit in patients with psychosis.~   "
70184|NCT02648308|"~     Results from the 5As Team (5AsT) Study have identified critical gaps in medical school~     curricula on obesity, leading to a wave of new family physicians who lack confidence and are~     poorly equipped to manage obesity with their patients. In an effort to address this gap, all~     first year medical residents training in family medicine at the University of Alberta during~     the 2015/2016 year will be required to take a 2 day workshop in Obesity Management as part of~     the Doctor-Patient Relationship Course. The comprehensive workshop provides medical residents~     with knowledge and training in obesity prevention and management through didactic lectures,~     experiential learning, and clinical practice. Participants were asked to complete and submit~     pre- and post- workshop assessment measuring self-reported confidence on aspects of weight~     management counselling, narrative reflections regarding the experiential components of the~     course, and measures to assess beliefs and attitudes towards people living with obesity. The~     purpose of our program evaluation was to assess the program's impact on residents' knowledge~     of obesity and attitude towards counselling patients with obesity, as well as to refine and~     further develop the course. Evaluation of the 5AsT-MD pilot project shows increases of~     residents' understanding of the complexity and chronicity of obesity, and an uptake of the~     5As framework and tools by residents to improve confidence and success of their weight~     management practice.~   "
70185|NCT02648295|"~     Blood management is an important part of successful total joint replacement. Loss of blood~     and transfusion can lead to poor outcomes for patients. The use of tranexamic acid (TXA) has~     become a standard component to many blood management programs. It is used to treat or prevent~     excessive blood loss during surgery and in various medical conditions such as excessive~     bleeding or hemorrhage. A normal body process prevents blood clots that occur naturally from~     growing and causing problems. When this process becomes overactive it can result in excessive~     bleeding, leading to increased blood transfusions. The proposed study seeks to evaluate the~     relationship between TXA and thromboelastogram (TEG) results.~   "
70186|NCT02648282|"~     This study will be looking at whether combining cyclophosphamide, pembrolizumab (an antibody~     that blocks negative signals to T cells), GVAX (pancreatic cancer vaccine), and SBRT (focused~     radiation) is effective (anti-tumor activity) and safe in patients with locally advanced~     pancreatic cancer.~   "
70187|NCT02648269|"~     This Study will first evaluate the safety and pharmacokinetics of a single intravenous dose~     of SEL-110, a nanoparticle containing rapamycin, in subjects with elevated blood uric acid~     levels. This will be followed, in separate subjects, by evaluation of the safety,~     pharmacokinetics, pharmacodynamics and immunogenicity of a single intravenous dose of~     SEL-212, SEL-037 (pegsiticase) plus SEL-110, in subjects with elevated blood uric acid~     levels. Uricase is an enzyme that converts uric acid to the readily soluble allantoin that is~     then excreted and SEL-110 is designed to prevent unwanted anti-drug-antibodies (ADAs) from~     forming.~   "
70188|NCT02648256|"~     Pneumocystis jirovecii pneumonia is a serious and frequent infection in immunocompromised~     patients, whose evolution is potentially fatal if untreated. It is the most common~     opportunistic infections classifying patients infected with human immunodeficiency virus~     (human immunodeficiency virus +) at the stage acquired immune deficiency syndrome. Data from~     the french Institute for Health Watch showed in 2011 that 31% of 1400 cases of acquired~     immune deficiency syndrome were revealed by Pneumocystis jirovecii pneumonia.~      Pneumocystis jirovecii pneumonia also increasingly concerns immunocompromised human~     immunodeficiency virus negative patients, due to the increasing use of immunosuppressive~     therapies (including corticosteroids), of anticancer cytostatics and biotherapies, in the~     context of grafts, transplants, but also from autoimmune or inflammatory chronic diseases.~      Recent data show that the number of cases occurring in patients Pneumocystis jirovecii~     pneumonia human immunodeficiency virus - in France is now higher than the cases occurring in~     Pneumocystis jirovecii pneumonia +. The severity of the Pneumocystis jirovecii pneumonia is~     increased in patients with human immunodeficiency virus -, in whom the evolution is faster,~     with mechanical ventilation often required and higher mortality, requiring a fast and early~     diagnosis. Routine diagnosis relies on the detection of the fungus in the bronchoalveolar~     lavage, using stains (May Grunwald Giemsa or immunofluorescence) and Polymerase Chain~     Reaction. Polymerase Chain Reaction provides a diagnostic gain in immunocompromised patients~     not infected with human immunodeficiency virus that may present a pejorative table quickly~     despite low fungal burden. However, the deoxyribonucleic acid of the fungus can sometimes be~     detected in the absence of scalable Pneumocystis jirovecii pneumonia, and then shows a~     pulmonary colonization by Pneumocystis jirovecii. It is therefore important to improve the~     positive predictive value of Pneumocystis Polymerase Chain Reaction, to guide the management~     of optimal patient.~      In this work, the investigators propose to evaluate the Polymerase Chain Reaction on~     oropharyngeal rinse, non-invasive sampling and therefore probably less often positive and~     specific active infection. The investigators will develop a quantitative Polymerase Chain~     Reaction to identify a fungal load threshold number of copies / mL for diagnosing~     Pneumocystis jirovecii pneumonia with better positive predictive value.~   "
70189|NCT02648243|"~     In Qatar, cardiovascular diseases (CVD) have become the leading cause of morbidity and~     mortality over the past two decades. Between 1991 and 2010, a total of 16,736 patients were~     admitted with ACS (Acute Coronary Syndrome) in Qatar. Despite the use of percutaneous~     coronary intervention (PCI), coronary artery bypass graft (CABG), and pharmacological agents~     to acutely reduce vascular risk, ACS patients are at high risk of having further~     cardiovascular events. Consequently, secondary cardiovascular risk reduction therapy is~     needed for all CAD (Coronary Artery Disease) patients. Clinical practice guidelines recommend~     that following ACS, patients should receive indefinite treatment with aspirin, a beta~     blocker, an angiotensin converting enzyme inhibitor (ACEI) or alternatively angiotensin II~     receptor blocker (ARB) and a statin. Less than 80% of ACS patients in Qatar use this~     quadruple combination after discharge. This creates a significant opportunity for pharmacists~     to improve CVD management and outcomes in Qatar. Nothing is known about the impact of Qatar~     clinical pharmacists as direct patient-care team members at discharge and post-discharge on~     the short-term and long-term outcomes of ACS patients. The proposed study is aimed to~     determine this impact. The investigators hypothesize that a clinical pharmacist-delivered~     intervention consisting of medication reconciliation and counseling at discharge and tailored~     follow-up post-discharge will decrease hospital readmissions, emergency department (ED)~     visits and all-cause mortality at 3 month, 6 months and 12 months after hospital discharge~     when compared with control arm and pharmacist delivered intervention at discharge only among~     ACS patients. The investigators also hypothesize that the effect of the intervention will~     increase patients' adherence to evidence-based secondary prevention medications for CAD~     (Coronary Artery Disease), and patient satisfaction with pharmacy services. Besides, this~     intervention will reduce the treatment burden on patients.~   "
70190|NCT02648230|"~     The model by which physicians measure the lack of blood flow in the vessels that supply blood~     to the heart muscle is called Fractional Flow Reserve (FFR). FFR is the measurement of the~     pressure across the vessels that supply blood to the heart. These are known as the coronary~     arteries. This study involves comparing two FFR wires, the St. Jude Medical Pressure Wire~     (PW) and the ACIST Navvus Microcatheter (MC) to check the accuracy of the devices. FFR allows~     real-time estimation of the effects of a narrowed vessel, whereas standard angiography can~     underestimate or overestimate narrowing, because it only visualizes contrast (the different~     areas of color) inside a vessel.~   "
70191|NCT02648217|"~     This trial is conducted in Africa and Asia. The aim of this trial is to compare efficacy and~     safety of insulin degludec/insulin aspart twice daily and biphasic insulin aspart twice daily~     in subjects with type 2 diabetes mellitus before, during and after Ramadan.~   "
70192|NCT02648204|"~     This trial is conducted in Asia, Europe and the United States of America (USA). The aim of~     the trial is to investigate efficacy and safety of semaglutide versus dulaglutide as add-on~     to metformin in subjects with type 2 diabetes.~   "
70193|NCT02648191|"~     Faced with the current obesity epidemic, new avenues of research into effective weight loss~     must be developed.~      Among the possible actions on obesity, vagus nerve stimulation has been shown in several~     studies to be effective in treating epilepsy or depression, at the same time inducing weight~     loss in those patients. Vagus nerve stimulation has also shown to be effective on weight loss~     in experimental animal studies. Vagus nerve stimulation has never been attempted in obese~     patients awaiting bariatric surgery.~   "
70194|NCT02648178|"~     This study will test feasibility, in smokers with lung, head & neck, and bladder cancers,~     that examines the effect of e-cigarette substitution, on measures of smoking-related toxicity~     and medical outcomes. The aim of the study is to determine the appeal of e-cigarettes~     compared to regular combustible cigarettes.~   "
70195|NCT02648165|"~     Depression (major depressive disorder; MDD) is a very common mental disorder. Research~     suggests that individuals with prior depressive episodes have a risk of the relapse or~     recurrence of MDD. Secondary prevention has been identified as a key goal in the long-term~     management of the disease. The current project aims to investigate whether group based~     Acceptance and Commitment Therapy (ACT) can reduce surrogate and clinical markers of relapse~     in a group highly vulnerable to depressive episodes. The group intervention will consist of~     eight sessions, and each group will consist of maximum 12 persons. The project also studies~     whether Attention Bias Modification (ABM) preceding the ACT intervention will enhance the~     effect. ABM will be administered over a fourteen days period prior to the ACT-intervention.~     Effect will be measured over a period of 12 months. The primary outcome is changes in~     depressive symptoms. ACT-specific secondary outcome measures are also included. Subjects with~     a history of major depression (n=200), currently in remission, will be recruited from~     Sørlandet Hospital (100 participants). Matched participants (100 participants) will be~     recruited at the University of Oslo. In the first phase, participants from Sørlandet hospital~     will be randomized to ABM treatment or control condition. In the second phase all~     participants from Sørlandet hospital will receive group based ACT treatment. Group based ACT~     and ABM represent interventions that are time and cost effective, and that could be made~     available to large number of individuals struggling with MDD.~   "
70196|NCT02648152|"~     Multicenter observational study to validate that the POLARSTEM™ is a state-of-the-art implant~     in terms of radiographic, clinical performance and long-term survivorship.~   "
70197|NCT02648139|"~     In the present randomized, controlled, double-blind clinical trial, we investigated the short~     term clinical efficacy of a dentifrice containing Eugenia uniflora L. ripe fruit extract in~     preventing gingivitis in children.~   "
72762|NCT02614547|"~     This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of~     the efficacy, safety, and pharmacokinetics of SAGE-547 Injection in adult female subjects~     diagnosed with severe postpartum depression~   "
70199|NCT02648113|"~     Anemia in patients with myocardial infarction (MI) is a relatively frequent issue, resulting~     in poorer outcome. There is equipoise regarding which transfusion strategy is best, and there~     is an international consensus on the urgent need for a randomized trial.~      The investigators hypothesize that a restrictive transfusion strategy is at least~     non-inferior to a liberal transfusion strategy on 30-day outcomes of MI patients with~     anemia. Given the costs and risks of transfusion, a cost-effectiveness and cost-utility~     analysis becomes key to determining the role of each strategy.~   "
70200|NCT02648100|"~     Muscle invasive (MIBC) and/or metastatic bladder cancer is associated with poor prognosis and~     no target therapies for this pathology are currently validated. By 40 gene expression~     signature realized on frozen samples, we have previously identified an aggressive sub-class~     of MIBC, called basal. This sub-class (20% of MIBC) showed strong EGFR dependence in vitro~     and in vivo (Rebouissou et al. Science Translational Medicine 2014). This observation~     suggests a possible response to EGFR targeted therapy in patients of this subgroup. Our aim~     is to establish a standard diagnostic tool to differentiate the basal subtype of bladder~     cancer and evaluate the effect of anti-EGFR therapy, by analyzing previous clinical trial~     (GETUG19) and preclinical models, which compare the classical chemotherapy to anti-EGFR~     associated chemotherapy.~   "
70201|NCT02648087|"~     There is a possible implication of sleep apnea syndrome via night-time intermittent hypoxemia~     in perturbation of quality of life and tumour progression to patients with a bronchial~     cancer.~      The aim of the study is to evaluate this possibility with the help of a night record of sleep~     and quality of life questionnaires.~   "
70202|NCT02648074|"~     Asthma is a chronic, inflammatory disease of the lung characterized by intermittent airway~     obstruction, airway hyperresponsiveness, presence of activated inflammatory cells,~     inflammatory mediators, and airway structural changes. Airway smooth muscle (ASM) cells~     actively participate in the remodelling and inflammatory processes through proliferation,~     release of proinflammatory cytokines, chemokines, and extracellular matrix (ECM) proteins.~     Eosinophils as essential inflammatory cells may be of importance in ASM remodelling. It is~     known that eosinophil induces ASM cells proliferation via the secretion of cysteinyl~     leukotrienes in asthmatics. However there is a possible direct eosinophil-ASM cells~     functional interaction by adhesion processes. It has been shown that integrins modulate ASM~     proliferation and contractile protein expression demonstrating allergen-induced ASM~     remodelling in an animal model of allergic asthma.~      Wingless/integrase-1 (WNT) signaling regulates not only a wide range of developmental~     processes, but its aberrant activation can lead to disease. Recently, it was confirmed that~     genes polymorphisms in the WNT signaling pathway are associated with impaired lung function~     in childhood asthma. It was also found for the first time a relevant role of noncanonical WNT~     signaling in TGFβ-induced ECM expression by ASM cells and identified WNT-5A is the most~     abundant WNT ligand with increased expression in asthmatics. It demonstrates that WNT-5A~     could contribute to remodelling of the airways. Unfortunately, the effect of eosinophil on~     WNT secretion by ASM cells at present is unknown.~      Despite the widely acknowledged significance of eosinophils in asthma pathogenesis, the~     mechanism of eosinophil induced ASM remodelling is unsolved.~   "
70203|NCT02648061|"~     Extensive research exists for cardio-pulmonary resuscitation (CPR) and the chance of~     successful return of spontaneous circulation (ROSC) is improved. Unfortunately, the overall~     prognosis after ROSC has not improved much and the in-hospital mortality is still reported to~     be 50 to 70 %. The post-resuscitation disease is now called the post-cardiac arrest~     syndrome (PCAS) and comprises 1) brain injury, 2) myocardial dysfunction and 3) systemic~     ischemia and reperfusion.~      Treatment of patients after cardiac arrest has often followed guidelines that were primarily~     developed for treatment of septic shock. It is still uncertain whether this is the optimal~     way to deliver circulatory support after cardiac arrest.~      There is a lack of studies assessing the relationship between the inflammatory response~     measured by inflammatory biomarkers and circulatory failure in PCAS.~      In this study a detailed description will be given of the clinical trajectory of the~     circulation and the inflammatory response during the first 5 days after cardiac arrest, and~     it will be investigated whether patterns of circulatory and inflammatory response may be~     predictive of deterioration of clinical state.~   "
70204|NCT02648048|"~     This is a single arm, multicenter, open-label, Phase 1b study to evaluate the safety and~     tolerability of vismodegib in combination with pirfenidone in participants with idiopathic~     pulmonary fibrosis (IPF) currently being treated with pirfenidone.~   "
70205|NCT02648035|"~     The purpose of this study is to evaluate the percentage of participants treated with~     subcutaneous (SC) Tocilizumab who are still on treatment after 52 weeks and the factors that~     play a major role in continuation of treatment.~   "
70206|NCT02648022|"~     To determine the effect of an integrated care protocol on antiviral treatment and sustained~     virologic response (SVR) rates following initiation of direct acting antiviral therapies~     (DAA) treatments in 2011.~   "
70207|NCT02648009|"~     The prevalence of congestive heart failure (CHF) in Canada is high, representing one of the~     health care system's most expensive diagnoses. Despite major advances in medicine, the~     mortality and morbidity from CHF remains great. Currently, magnetic resonance imaging (MRI)~     is used for non-invasive imaging of the cardiovascular system to enable the structure and~     anatomy of the organ to be visualized. However, current MRI methods have limitations when~     assessing and aiding in the management of CHF. A new imaging method has recently been~     developed that is showing great promise as a tool in the management of patients with CHF.~     Rapid imaging of biochemical reactions within myocytes using MRI has recently become possible~     through the use of the Dynamic Nuclear Polarization (DNP) and dissolution method.~     DNP-dissolution results in an intravenous contrast agent that is hyperpolarized, producing~     a magnetic signal that is enhanced by up to 100,000 fold. The particular agent is carbon-13~     labelled pyruvate. In this study, we demonstrate the first 13C-metabolic images of the human~     heart, along with the required hardware and data acquisition methods.~   "
70208|NCT02647996|"~     To compare functional connectivity after severe traumatic brain injury (TBI) between a group~     of post-comatose TBI with restored consciousness and a group of post-comatose TBI with~     persistant disorder of consciousness at admission in rehabilitation~   "
72994|NCT02611531|"~     The purpose of this study is to evaluate the effectiveness of two different ways to teach~     subjects while hospitalized how to use respiratory inhalers and to follow-up after discharge~     home from the hospital to determine durability of the education.~   "
70209|NCT02647983|"~     Prostate cancer is the most common malignancy among men in the United States and Canada.~     Suspicion of prostate cancer with modern screening tests, such as digital rectal exam (DRE)~     and prostate serum antigen (PSA) require ultrasound-guided biopsy for pathological diagnosis.~     However, this technique misses cancer in nearly one quarter of patients and finds clinically~     insignificant disease in another third of patients, resulting in over-treatment and~     unnecessary morbidity.~      MRI is the best imaging method for prostate cancer detection, but current techniques cannot~     reliably predict tumour grade and are often unreliable for localizing cancer, particularly~     within the transition zone, where specificity is low. The primary objective of this pilot~     study is to evaluate the added benefit of localizing prostate cancer and predicting tumour~     grade with Hyperpolarized 13C MRI, in addition to traditional T2-weighted and~     diffusion-weighted MR imaging.~      The investigators propose a pilot study, in men diagnosed with prostate cancer awaiting~     prostatectomy, with the specific goals of comparing pre-operative imaging findings to ground~     truth histology, using whole-mount prostate specimens. The results of this study will provide~     insight into the prostate cancer disease signatures with MRI and determine if there is added~     benefit for incorporation of this new technique into future clinical MRI protocols. If future~     imaging tests could determine the size, grade and extent of disease, this would open the door~     for less invasive, localized treatment options with reduced morbidity.~   "
70210|NCT02647970|"~     The aim of this study is to examine if changing stearoyl-coenzyme A desaturase-1 (SCD1)~     activity through dietary interventions can increase energy metabolism in humans.~   "
70211|NCT02647957|"~     Code Stroke is a system for the rapid identification, pre-notification and transport of acute~     ischemic stroke patients. The objective of this study was to define quality indicators and to~     compare treatment outcomes in hospitals where Code Stroke has been implemented and hospitals~     without the use of Code Stroke (control patients).~   "
70212|NCT02647944|"~     This study was being done to assess the stomach emptying effect of a maximum dose of 3 mg~     Liraglutide compared to placebo in subjects who are overweight or obese. Liraglutide is a~     medication approved by the Food and Drug Administration (FDA) for routine clinical use.~   "
70213|NCT02647931|"~     Muscle tension dysphagia is a novel diagnostic taxonomy describing a subset of patient~     population with reported dysphagia who exhibit normal oropharyngeal and esophageal swallowing~     function as evidenced by videofluoroscopic swallow study. These patients also demonstrate~     abnormal supraglottic muscle tension during laryngoscopy as well as signs of laryngeal~     hypersensitivity and laryngopharyngeal reflux. Treatment of these patients with Proton Pump~     Inhibitor (PPI) therapy is a common practice however voice therapy invention targeting the~     unloading of the supraglottic muscle tension has been shown to be highly effective in symptom~     resolution per the investigators' clinical experience. The study is designed to answer~     efficacy of treatment being offered to patients with muscle tension dysphagia.~   "
70214|NCT02647918|"~     The purpose of this study is to evaluate the effect of mild, moderate, or severe renal~     impairment, or end-stage renal disease (ESRD) requiring hemodialysis (HD), on the safety and~     tolerability of 1 or 2 single doses of sotagliflozin compared with healthy,~     demographically-matched subjects with normal renal function.~   "
70215|NCT02647905|"~     The purpose of this clinical investigation is to evaluate the accuracy of the Senseonics~     Continuous Glucose Monitoring System (Senseonics CGM System) measurements when compared with~     reference standard measurements The investigation will also evaluate safety of the Senseonics~     CGM System usage.~   "
70216|NCT02647892|"~     The purpose of this study is to determine the optimal amount of lidocaine buffering needed to~     decrease injection pain when administering local anesthesia.~   "
70217|NCT02647879|"~     The main aim of this study is to test in the Icelandic population the hypothesis that a~     nationwide treatment program which offers effective treatment to all known cases of Hepatitis~     C with the aim of halting HCV (Hepatitis C virus) transmission will lead to a reduction in~     incidence and disease burden associated with chronic HCV infection.~   "
70218|NCT02647866|"~     The purpose of this study is to determine the safety and tolerability of administration of~     multiple ascending doses of KHK4083 and to select the highest dose tolerated by subjects with~     moderately active Ulcerative Colitis (UC) followed by a Long-term Extension Therapy (LTE)~     phase for eligible subjects with a clinical response.~   "
70219|NCT02647853|"~     This Phase 1, randomized, placebo-controlled, double-blind, healthy volunteer study tested~     the safety, tolerability, and plasma pharmacokinetics of two different concentrations of TAT4~     Gel administered once daily to 50 cm2 of skin for 14 days.~   "
70220|NCT02647840|"~     This study wants to investigate treatment for patients with common voice disorders where no~     surgical or medical treatment is needed. A voice disorder is when your voice is croaky,~     hoarse or when you lose it altogether. This can be a serious problem for people as it stops~     them from participating in their normal life (for example in their jobs, hobbies, family and~     wider social life).~      This study will look at our most commonly used method of treatment for voice problems. This~     method is based on physical exercises which work on the muscles which produce the voice. This~     voice work was originally developed by Jo Estill, a singer and scientist, and is widely used~     in voice coaching. Though many Speech and Language Therapists (SLTs) provide voice therapy~     based on the Estill model, there is no clinical evidence to support its use.~      The aim of this study is to test the design for a larger research study into the effects of~     voice therapy based on Estill model of voice. We want to find out if our tests work and are~     easy to use, and to check that the study methods are right and would work on a larger scale.~     It is a feasibility study, and therefore allows us to test whether this study can be done.~     Another important part of this study is to involve patients in developing research. We want~     to find out what patients think about the treatment they receive, and about taking part in a~     study.~      The way this study will work is that patients who have agreed to take part will have between~     four and six voice therapy appointments, just like they would if they were not part of the~     study. Voice test results from before and after treatment will be compared and carefully~     studied. After patients taking part in the study have finished their treatment, they will be~     asked about their experience of voice therapy, and of being in the study. Much of what will~     be done as part of the study is identical to what is normally done in treatment, however we~     will look in detail at all the tests, and we need permission from participants to use their~     test results and include their comments.~      It is important to learn more about voice therapy and to improve voice therapy for patients~     with this type of voice problem. By finding out more what patients think about the treatment~     we provide, what tests to use, and about how best to run a research trial, we will be able to~     plan further research and hopefully be successful at a next large research grant application.~   "
70245|NCT02647515|"~     To determine the efficacy of intravitreal ranibizumab injection as adjuvant therapy in the~     treatment of postvitrectomy diabetic vitreous hemorrhage (PDVH) accompanied by neovascular~     glaucoma (NVG) as a means of preventing recurrent vitreous hemorrhage （VH） and optimizing~     postoperative intraocular pressure（IOP）control.~   "
71611|NCT02629588|"~     Appraised the empirical evidence of effectiveness of sensory stimulation to improve arousal~     and alertness for persons in a coma or persistent vegetative state after traumatic brain~     injury (TBI). Databases were searched and nine articles met inclusion criteria.~   "
70221|NCT02647827|"~     The hypothesis is that acupuncture is equally effective as metformin (both treatments~     combined with lifestyle management) in improving whole body glucose homeostasis in insulin~     resistant women with polycystic ovary syndrome (PCOS), and that both are superior to~     lifestyle management alone. The investigators hypothesize that acupuncture and metformin~     induce ovulation and improve hyperandrogenism, as well as health related quality of life~     (HRQoL) and symptoms of anxiety and depression. Although equally effective (acupuncture and~     metformin), the investigators hypothesize that acupuncture is associated with less negative~     side-effects. The investigators also hypothesize that these treatments have the potential to~     restore epigenetic and molecular alterations in target tissues (endometrial-, adipose-, and~     skeletal muscle tissue) and thus have the potential to prevent the development of type 2~     diabetes (T2D).~   "
70222|NCT02647814|"~     Objective: To conduct a pilot randomized controlled trial comparing the effectiveness of a~     parent support intervention consisting of periodic text messages and educational support~     (video, collateral materials),and usual care on the healthcare engagement of limited English~     proficient (LEP) Latino parents during their child's first year and to examine its impact on~     healthcare utilization and primary care quality.~   "
70223|NCT02647801|"~     The aim of this trial is to test a novel network approach (Bringmann et al., 2013), which~     enables to investigate the complex, interdependent network of self-control and its influences~     in everyday life. By adding an intervention to the network, such as mindfulness training, it~     is also possible to explore the way mindfulness changes connection strengths between network~     variables.~      For six weeks, an ambulatory assessment and additional seven weekly laboratory sessions are~     conducted with 120 students from the Johannes Gutenberg University Mainz who are randomized~     to a control (n=60) or intervention condition (n=60). Pre and post measurement sessions take~     place to assess self-reported trait self-control and mindfulness and a behavioral measure of~     mindfulness (Levinson, Stoll, Kindy, Merry & Davidson 2014). Participants of both the~     experimental and control condition come to five weekly lab meetings in which they fill out~     questionnaires to assess changes in self-reported self-control and mindfulness. But only~     participants of the experimental condition take part in weekly computer based mindfulness~     trainings. During the ambulatory assessment, participants complete questionnaires six times a~     day via mobile phones that are randomly prompted and answer questions about state~     self-control, motivation, affect, and current situation.~   "
70224|NCT02647788|"~     The purpose of this research study is to find out if taking Acetaminophen with Ibuprofen~     (e.g. Tylenol + Advil), a non-opioid regimen, provides the same type of pain relief after~     hand surgery compared to Acetaminophen and codeine (e.g. Tylenol 3), an opioid regimen.~   "
70225|NCT02647775|"~     Video-assisted thoracoscopic surgery (VATS) for thoracic surgery is practical, has been shown~     to reduce postoperative discomfort, and has improved cosmetic results when compare to open~     thoracotomy. The specific aims of this project are: to clarify the physiologic and~     immunologic effects of different approaches for minimally invasive thoracic surgery: (1)~     multiple-port VATS; (2) single-port VATS~   "
70226|NCT02647762|"~     This trial will test the hypothesis that the administration of CF101, a novel~     anti-inflammatory agent, to patients with rheumatoid arthritis will relieve signs and~     symptoms of the disease. CF101 effect will be in comparison to MTX in this study population.~   "
70227|NCT02647749|"~     This current care protocol follows the biomedical research protocol entitled Non-invasive~     mapping of the heart ECG high amplification that demonstrated the clinical value of~     noninvasive Cardioinsight® mapping system.~      Guide the management of patients hospitalized for cardiac rhythm radiofrequency ablation of~     cardiac arrhythmias, implantation or programming of a pacemaker, or assess the risk of~     serious arrhythmias or sudden death, with the currently used non-invasive mapping routine.~     The results obtained with non-invasive mapping will be compared with those obtained with the~     conventional method without non-invasive mapping.~   "
70228|NCT02647736|"~     Kinetics of Copeptin in response to osmotic alterations in healthy volunteers~   "
70229|NCT02647723|"~     The purpose of the study is to test whether nutritional supplementation during pregnancy is~     associated with 1) improved maternal health during pregnancy; 2) improved infant birth and~     neurodevelopmental outcomes, and 3) whether the association between nutritional~     supplementation during pregnancy and infant outcomes is partially mediated by reductions in~     maternal perceived stress and stress reactivity during pregnancy.~   "
70230|NCT02647710|"~     PHAT Life: Preventing HIV/AIDS Among Teens, is a uniquely-tailored intervention designed for~     recently-arrested juvenile offenders on probation. The program will teach teens about~     HIV/AIDS, sexually transmitted infections, and safer decision-making. The PHAT Life Research~     Study is a 2-arm randomized controlled trial of the PHAT Life Intervention. The investigators~     will test and compare PHAT Life to the health promotion control group on adolescent risky~     sexual behavior, substance use, and theoretical mediators.~   "
70231|NCT02647697|"~     To evaluate the pharmacokinetics (PK) profile of Radiprodil in suspension form in healthy~     adult subjects.~   "
70232|NCT02647684|"~     The purpose of the study is to assess the characteristics of parents who enroll in parenting~     interventions and to assess the utility and efficacy of a self-directed Triple-P intervention~     for parents of children with a diagnosis of cancer. The study aims to recruit parent(s) or~     primary caregiver of children with a diagnosis of cancer.Participants will be parents of~     children aged between 3-10 years who have had a diagnosis of cancer for 6 months or more.~     Recruitment will take place nationally via cancer voluntary groups/charities and other~     relevant organisations. The project will be advertised through these organisations and their~     various media outlets such as newsletters and social media pages (e.g. Facebook). All data~     collection will take place online. Following completion of the initial survey, parents will~     have the option to opt in to a case series whereby 10 parents will have the opportunity to~     receive the Triple P Every parents self- directed workbook to complete over 10 weeks.~   "
70273|NCT02647151|"~     Photodynamic therapy technique (PDT) is a conventional technique which is performed applying~     the product under occlusion lesions, let it incubate for 3 hours and then exposed skin to a~     light source, usually red.~      The conclusions of efficacy, tolerance and satisfaction that today are known about PDT with~     MAL, but not with ALA, which is a new photosensitizer indicated for Actinic Keratoses. The~     pharmaceutical form of ALA is a gel, which gives a hypothetical better penetration and~     consequently it is more effectively.~   "
70233|NCT02647671|"~     In the proposed study, investigators will conduct a 90-day dietary intervention study in~     human subjects. Thirty individuals at risk for adenomatous colon polyp formation will be~     randomized to receive a calcium and multi-mineral-rich natural product (Aquamin) or a~     comparable level of calcium alone. There will also be a placebo group. Prior to ingesting the~     study agents and following the course of treatment, colonic biopsies will be obtained by~     sigmoidoscopy and quantitatively examined for markers of growth and differentiation. In this~     study, metabolomic and microbial profiles will also be generated from fecal and colon mucosal~     samples taken at baseline and study endpoint.~   "
70234|NCT02647658|"~     Low back pain (LBP) is a common problem among US adults. Initial episodes tend to be~     self-limited (acute), but some people can progress to a state of persistent pain. Often~     termed chronic LBP (cLBP), this condition can cause prolonged difficulty with most daily~     activities, including job performance. Most patients see chiropractors or primary care~     physicians (PCPs) for initial episodes of LBP. This study will compare two approaches for~     preventing patients with acute LBP (aLBP) from developing cLBP. Both treatments can be~     delivered in an outpatient PCP setting. The first approach is to provide PCPs with~     information regarding a patient's risk of transitioning from aLBP to cLBP and to encourage~     PCPs to treat patients according to accepted clinical guidelines. The second approach is to~     provide the same risk information and have PCPs team up with physical therapists to deliver~     psychologically-informed physical therapy (PIPT) for those patients determined to be at high~     risk for transitioning to cLBP. PIPT is designed to help patients identify and overcome~     physical and psychological barriers to recovery. The 3,000 patients expected to be recruited~     from five regional sites (Pittsburgh, PA; Boston, MA; Baltimore, MD; Charleston, SC; and Salt~     Lake City, UT) will start the study when their LBP is in an acute phase. The study's primary~     aims are to compare the proportions of cLBP and measures of functional ability between the~     two groups at 6 months. Secondary aims are to compare these outcomes between the two groups~     at 12 months and measure the number of low back-related x-rays, MRIs, surgeries, and other~     medical procedures during the follow-up period. The same outcomes will be assessed for an~     observational cohort of 9,000 patients with aLBP at low to medium risk for transitioning to~     cLBP across the 5 sites. This study was designed with input from a variety of national and~     local stakeholders, including patients with LBP, providers, payers, professional~     organizations, purchasers, and policy representatives.~   "
70235|NCT02647645|"~     The purpose of this study is to develop pilot data on the potential efficacy of~     computer-based cognitive training or the combination of computer-based cognitive training~     with transcranial direct current stimulation (tDCS) in improving cognitive function in~     persons with HIV-related mild neurocognitive disorder (MND). tDCS is a noninvasive brain~     stimulation technique in which a small direct current (1-2 mA) is applied to the scalp during~     a cognitive or motor activity, inducing a very small current that affects specific neural~     circuits related to the site at which electrodes are placed. tDCS has been judged safe and~     has shown significant treatment effects in studies with other populations, but has not been~     extensively studied in individuals with HIV infection. tDCS has been shown to facilitate~     learning in a number of studies, suggesting that it may improve or enhance learning in those~     with cognitive problems. As HIV infection is associated with decrements in a number of~     cognitive skills, including working memory, executive functions, and psychomotor speed that~     are related to individuals' functional status and medication adherence, the demonstration of~     a technique to enhance the effects of cognitive training in this population would have~     substantial clinical benefits as well as scientific value.~   "
70236|NCT02647632|"~     The primary objective of this study is to estimate, in HCV genotype 1 or 4-infected patients~     who failed a prior DAA bitherapy with Sofosbuvir, the efficacy of a treatment with~     Grazoprevir/Elbasvir, Sofosbuvir and Ribavirin in the two treatment groups and compare the~     rate of sustained virological response (SVR) 12 weeks after 16 or 24 weeks of this treatment.~     SVR12 is defined as HCV RNA < LLOQ (either TD[u] or TND).~   "
70237|NCT02647619|"~     Aim:~      Clinical RCT comparing functional results and recurrence rate following enzymatic treatment~     vs. needle aponeurotomy.~      Materials and methods:~      30° or more contracture of only one metacarpophalangeal (MCP) joint contracture of one of the~     three ulnar digits and less than 20° for the adjacent proximal interphalangeal (PIP) joint.~     Patients with primary disease of the hand. Total of 80 patients needed to detect difference~     of 13.5°.~      1) Needle aponeurotomy 2) Clostridium Histolyticum treatment. Clinical follow ups 1,4 weeks,~     16 weeks and 1,2 and 5 years. Functional outcome scores: URAM, Quick Dash, EQ5D, brief MHQ,~     VAS pain and VAS patient satisfaction. Total passive extension contracture reduction,~     recurrence rate and registration of complications.~   "
70238|NCT02647606|"~     Videolaryngoscope is useful to improve the laryngeal view, especially during difficult~     intubation. There are several kinds of videolaryngoscopes and it is applicable during~     nasotracheal intubation. In this study, the investigators will compare the McGrath~     videolaryngoscope and Pentax-AWS with Macintosh laryngoscope for nasotracheal intubation in~     patients with manual in-line stabilization.~   "
70239|NCT02647593|"~     Laboratory change induced by common bile duct (CBD) stone is in general observed as the~     higher elevation of alkaline phosphatase (ALP) and gamma-glutamyl transpeptideas (ɤ-GT), in~     comparison to those of aspartate aminotransferase (AST) and alanine aminotransferase (ALT).~     However, some patients with CBD stone show the marked increased level of aminotransferase,~     which sometimes leads to misdiagnose those as liver disease caused by viral hepatitis,~     ischemia, and drug toxicity. The aim of this study is to investigate the clinicopathologic~     features of patients with CBD stones with the high level of aminotransferase in serum.~   "
70240|NCT02647580|"~     Failure to thrive (FTT) is an expression for inadequate growth in the early childhood and~     thus, a sign of undernutrition. This study will include children with FTT, and compare with~     existing data from children with normal and excessive growth.~      The overall aim of this study is to explore whether 1) children who develop FTT with no~     organic explanation differ from healthy normal weight and overweight children in their basal~     level of appetite-regulating hormones and 2) if inadequate, normal and excessive growth in~     children can be partly predicted by variation in their gut microbiome and metabolome.~   "
70241|NCT02647567|"~     Caffeine is a methylxanthine commonly consumed by the population for their psychostimulant~     properties, and their intake when in moderate doses seem to produce positive effects on~     stress, mood and memory. So, understanding that a positive effect of aerobic exercise can be~     displayed also on cognition, as caffeine, when in proper proportions, the investigators do~     not know if the joining of the two strategies into a single activity would be able to promote~     additional effects enhancing cognitive processes related to memory, attention, and motor~     reaction time.~   "
70242|NCT02647554|"~     A Prospective, Multi-Centre, Double-Blind, Randomized, Placebo-Controlled, Trial of~     Ulinastatin Treatment in Adult Patients with Sepsis and Septic Shock in China~   "
70246|NCT02647502|"~     Experimental studies of the experimental autoimmune encephalomyelitis (EAE), a mouse model of~     multiple sclerosis, indicate that the number of calories fed to mice prevent EAE and are also~     associated with less severe disease in mice who do develop the disease. Currently, whether~     these results translate favorably in humans is unknown. This is a pilot trial of testing two~     caloric restriction (CR) diets versus a control diet in multiple sclerosis (MS) patients: one~     continuous caloric restriction (CR) diet where a small number of calories will be restricted~     every day or another intermittent CR diet where a caloric intake will be restricted more~     severely 2 days per week. Participants are randomized to one of the diets, and for the first~     8 weeks, will receive standardized, prepared meals tailored to the specific diet. At the~     conclusion of the controlled feeding study, all participants will transition to an unblinded~     phase for an additional 40 weeks where they are provided with instructions to follow an~     intermittent CR diet.~   "
70247|NCT02647489|"~     Despite having developed robust acquired immunity against complications of malaria, women can~     return to a susceptible state during their first pregnancies and contribute significantly to~     the burden of severe malaria in highly endemic areas. Naturally acquired protection against~     placental malaria correlates with the presence of high concentration of immunoglobulin G~     molecules (IgGs) against VAR2CSA, a parasite protein of the var gene family that is essential~     for the binding of infected erythrocytes to CSA in the placenta.~      To induce high concentrations of specific IgGs, subjects will receive escalating doses of~     PAMVAC vaccine antigen adjuvanted with Alhydrogel, Glucopyranosyl Lipid Adjuvant-Stable~     Emulsion (GLA-SE) or Glucopyranosyl Lipid Adjuvant-Liposome-QS-21 Formulation (GLA-LSQ).~     Three injections with the same dosage and adjuvant will be done, each 28 days apart (Day 0,~     28 and 56). Control subjects will receive physiological saline instead of the vaccine and~     dose escalation will be staggered to ensure safety during the trial.~   "
70248|NCT02647476|"~     Immunomodulating enteral nutrition in the perioperative period may reduce postoperative~     complications in cancer patients. Little is known if this effect translates to the better~     survival.~      The aim of study was to assess the impact of postoperative immunomodulating enteral nutrition~     on postoperative complications and survival of gastric cancer patients.~      The group of 98 gastric cancer patients were randomly assigned for postoperative~     immunomodulating enteral nutrition n=44 (Reconvan ,Fresenius Kabi), or standard enteral~     nutrition n=54 (Peptisorb, Nutricia). Postoperative complications, mortality, 6-month, 1-year~     and 5-year survival were analyzed.~   "
70249|NCT02647463|"~     Attachment and Biobehavioral Catch-up (ABC) is a manualized 10-session intervention delivered~     in families' homes or other places of residence. By helping parents of infants provide~     nurturance when their children are in distress, follow their children's lead, and behave in~     non-frightening ways, the ABC intervention has been previously found to enhance children's~     attachment quality and children's ability to regulate behavior, physiology, and emotions. The~     purpose of the present study is to examine the effectiveness of ABC in the context of~     community-based implementation efforts. Outcome assessments will include parent sensitivity,~     attachment quality, and cortisol regulation. The investigators hypothesize that parents~     randomly assigned to receive the ABC intervention will show higher levels of sensitivity at~     follow-up than parents randomly assigned to the waitlist control condition; and children~     randomly assigned to the ABC intervention will show higher rates of secure attachment and~     more normative profiles of cortisol than children randomly assigned to the waitlist~     condition.~   "
70250|NCT02647450|"~     An estimated 90,000 patients are suffering from long term gastrointestinal problems after~     cancer treatments, and whilst the National Cancer Survivorship Initiative have been working~     to develop specific pathways of care, these pathways lack in both specialised tariff funding~     and awareness. This study aims to assess the economic and personal impact on patients~     suffering from stomach and/or bowel problems after cancer treatment prior to referral to the~     Gastrointestinal and Nutrition Team (GIANT) at the Royal Marsden Hospital. All patients~     referred to the GIANT service (including private patients but excluding re referrals) will be~     offered participation in the study.~      The study will consist of a 9 page patient retrospective questionnaire, asking questions~     about investigations and medications prescribed over the past year, as well as costs and~     methods of trying to treat their symptoms themselves, and the personal cost to themselves of~     their symptoms through loss of work and emotional impact. As this questionnaire asks patients~     questions about the past year, and thus can be difficult to answer accurately, patient~     answers will be validated for reliability by sending a 1 page questionnaire to their GP~     asking the same questions about clinic visits concerning stomach/bowel problems,~     investigations and medications prescribed in the past year. Once this data is collected from~     the participants, and the study has finished, the average cost of clinical interventions,~     economic impact, and personal impact, will be calculated.~      The results from this study will be useful in helping to show the economic burden of GI~     symptoms, and will provide evidence as to the economic benefit of specialised clinics for the~     consequences of cancer treatment; highlighting the need for a nationally recognised algorithm~     for management.~   "
70251|NCT02647437|"~     Levetiracetam (LEV: (S)-α-ethyl-2-oxo-pyrrolidine acetamide) is an~     anticonvulsant/antiepileptic drug. The specific aim of this study is to assess the efficacy~     of low-dose LEV in reducing hippocampal activity in schizophrenia. The investigators also~     hypothesize that LEV will improve neurocognition in patients with schizophrenia.~   "
70274|NCT02647138|"~     Many patients complain to clinicians that they have difficulty sleeping appears to be due to~     environmental noise. There is a common perception that acute noises are more troublesome than~     continuous noises in the effect on individual sleep quality. Therefore the goal is to use a~     Marpac white noise maker with a continuous noise to see its effect on individuals that have~     difficulty sleeping in a high noise environment.~   "
70275|NCT02647125|"~     This primary objective of the trial is to study whether the local control of Huachansu plus~     thoracic radiotherapy is better compared to thoracic radiotherapy alone for patients with~     esophageal squamous cell carcinoma. It's a phase II study, 134 patients are expected to be~     recruited into the trial.~   "
70276|NCT02647112|"~     Clinical trial to determine the performance characteristics (sensitivity and specificity) of~     the Bladder EpiCheck test compared to the gold standard cystoscopy and pathology.~   "
72995|NCT02611518|"~     The purpose of this study is to look at how taking JNJ-54861911 every day will effect the~     amount of rosuvastatin or metformin in your blood after taking only a single dose of either~     one.~   "
70252|NCT02647424|"~     Polycystic ovary syndrome (PCOS) is one of the most common endocrinopathies, affecting 5% to~     10% of women of reproductive age. Women with PCOS suffer from anovulatory infertility.~     Following lifestyle modification with weight reduction in obese PCOS women, clomifene citrate~     (CC) is considered the first line treatment for ovulation induction (OI) in these women.~     75-80% of women will ovulate after CC administration. However, there is a discrepancy between~     the ovulation rate and pregnancy rate, which was reported to be 22% per each ovulating cycles~     after CC. Other alternatives, including gonadotropin injections and laparoscopic ovarian~     drilling, carried different disadvantages, such as costly treatment and risks of ovarian~     hyperstimulation syndrome and multiple pregnancy rate in gonadotrophin therapy and surgical~     risks and risk of ovarian failure in surgical treatment.~      The use of aromatase inhibitor, letrozole (LTZ), in reproductive medicine started in 2001.~     After this publication, there have been many groups of investigators studying the use of LTZ~     either in OI or ovarian stimulation in IVF cycles. A large multicentre randomized trial~     reported a significantly higher ovulation rate and live-birth rate comparing LTZ with CC. In~     majority of the publications, the multiple pregnancy rate was lower in LTZ group than in CC~     group. This can be attributed to the higher chance of monofollicular development after LTZ~     compared with CC. However, there is no information comparing the hormonal profile and~     follicular development after letrozole and CC.~      Mild ovarian stimulation using LTZ or CC in conjunction with intrauterine insemination is~     commonly offered to ovulatory women with unexplained infertility, minimal endometriosis or~     mild factor to improve the pregnancy rate. There is again no information comparing the~     hormonal profile and follicular development after letrozole and CC in ovulatory women.~      The aim of this study is to compare the hormonal profile after the use of LTZ and CC in~     anovulatory PCOS women and ovulatory women with unexplained subfertility. The hypothesis is~     that the FSH risk after LTZ is shorter than that of CC.~   "
70253|NCT02647411|"~     The purpose of this study was to evaluate the increased prevalence of myopia among patients~     in different periods in an ophthalmologic hospital in Goiania. There has been an increase of~     myopia prevalence around the world especially in some Asian countries. The investigators~     intend to analyze if this growing tendency is also present in our hospital, and if it exist~     how much is this growth.~   "
70254|NCT02647398|"~     Breast and colon cancer survivors with no evidence of disease, who score less than 45 in the~     PREDICT questionnaire for fatigue, will be randomized to a supervised strength program versus~     a supervised resistance program. The primary objective is improvement of cancer-related~     fatigue.~   "
70255|NCT02647385|"~     The serratus anterior muscle plane (SAM) block associated with pectoral nerve block type I~     (PEC I) may be a safe and effective alternative for the intraoperative of breast surgery,~     since there is evidence of pain reduction. However, correlation between regional anesthesia,~     postoperative pain and inflammatory response in breast surgery has not been demonstrated. The~     aim of this study is to compare the standard intravenous analgesia versus systemic analgesia~     associated with the SAM block and PEC I during breath cancer surgery. The following~     parameters will be evaluated: consumption of opioid intra and post-operative; post-operative~     pain and release of plasma inflammatory cytokines. It is a clinical prospective, randomized~     and controlled study. 50 individuals will be randomly divided into two groups. A group of~     patients receive general anesthesia during surgery and intravenous analgesia after the~     surgery and another group will receive general anesthesia associated with SAM and PEC I block~     during intraoperative and postoperative systemic analgesia. The postoperative pain will be~     assessed using the Visual Analogue Scale pain in the recovery room and 24 hours after~     surgery. Blood sample will be collected for determination of serum cytokines before surgery~     and 24 hours after the surgery.~   "
70256|NCT02647372|"~     This study provides an evaluation of 30 patients in 3 years, from the Unified Health System~     (SUS) irrespective of region of the country, signed with clinical Parkinson's disease in its~     intermediate stage and that the drug therapy is limited by side effects or beneficial effects~     provided by prior medication no longer be obtained even at high doses and have therefore the~     indication for treatment with deep brain stimulation.~   "
70257|NCT02647359|"~     This is a Phase 2, randomized, double-masked, placebo-controlled study of ataluren in~     patients with aniridia caused by a nonsense mutation. Patients will receive masked study drug~     for 48 weeks followed by open-label ataluren for another 48 weeks. Safety and efficacy will~     be assessed.~   "
70258|NCT02647346|"~     The purpose of this study is to investigate the accuracy of a Smart Foot Mat for signals~     associated with diabetic foot ulcers in high-risk patients.~   "
70259|NCT02647333|"~     In order to reduce cardiovascular risk, current European guidelines recommend a diet low on~     saturated fatty acid through replacement with polyunsaturated fatty acids (PUFA).~     Polyunsaturated fatty acids can be classified into omega-3 and omega-6. However the results~     from recent meta-analyses investigating coronary risk outcomes did not clearly support a low~     intake of saturated fatty acids and a high intake of omega-3 or omega-6. The aim of this~     study is to investigate the short term effects of a high intake of PUFAs on microvascular~     function, lipids, inflammation and other cardiovascular risk factors in inactive patients~     with increased waistline.~   "
70260|NCT02647320|"~     The hypothesis of this Phase 2, 12-week study, is that DS-8500a will improve glycemic control~     relative to placebo, based on changes in HbA1c, with acceptable safety and tolerability, in~     patients with Type 2 Diabetes Mellitus (T2DM) who are treated with metformin.~   "
70261|NCT02647307|"~     The proposed study is not hypothesis testing but is intended to explore the effects of~     different ethnic groups (Caucasian, Japanese, Chinese, and Korean) on the PK~     (pharmacokinetic), PD (pharmacodynamic), and safety of an IV infusion of DS 1040b.~      Subjects entering the study will receive a single 12 hour infusion of DS-1040b and be~     followed up to assess the effects on ethnicity on blood levels of DS-1040b as well as safety~     & tolerability.~   "
70262|NCT02647294|"~     Patients with metabolic syndrome and Nonalcoholic fatty liver disease (NAFLD) will be~     randomly allocated for the treatment with n-3 PUFA (3.6 g/day) or placebo for 12 months. At~     the beginning and at the end of the study basic clinical and anthropometric data, as well as~     parameters of liver steatosis and fibrosis will be tested.~   "
70263|NCT02647281|"~     This study is a Phase 1, randomized, double-blind (Sponsor unblinded), placebo controlled,~     dose escalation study to determine the safety, tolerability and pharmacokinetics (PK) profile~     of GSK3389404 as single (Part 1) and multiple subcutaneous (SC) injections (Part 2) in~     healthy subjects. This study represents the first administration of GSK3389404 in humans to~     define the safety, tolerability and PK following single and multiple doses of GSK3389404 in~     healthy subjects.~   "
70277|NCT02647099|"~     ALASCCA is a randomized, parallel group, double blind, multicenter, placebo-controlled,~     biomarker-based study of adjuvant treatment with low dose aspirin in patients with colorectal~     cancer. Hypothesis is that patients diagnosed with colorectal cancer and somatic mutations in~     PI3K pathway can significantly improve survival if treated with low dose aspirin.~   "
96200|NCT02307968|"~     To observe the patient's preference, pain perception, and usability between inner and outer~     upper thigh for insulin therapy. To add another injection site for insulin therapy.~   "
70264|NCT02647268|"~     Postpartum hemorrhage (PPH) is the loss of more than 500ml of blood within 24 hours after~     delivery. It is a major cause of maternal morbidity and mortality across the globe.~      Oxytocin is a naturally-occurring hormone that causes the uterus to contract, thereby causing~     labor. A synthetic form of oxytocin is used in obstetric medicine in the same way. It causes~     the uterus to contract by acting at the oxytocin receptor (OTR). It is used for both the~     prevention and the treatment of PPH. By causing the uterus to contract, it constricts the~     blood vessels within it, thus reducing bleeding.~      Oxytocin is also used to augment labor in women with slow labor progression. Desensitization~     of the OTR after prolonged exposure to oxytocin occurs, leading to reduced contractions of~     the uterus with the same doses of oxytocin. This has been demonstrated in previous studies~     done by the investigators. The resultant need for a higher oxytocin dose to cause adequate~     uterine contraction has also been demonstrated in laboring women having received oxytocin for~     labor augmentation.~      Magnesium sulphate (MgSO4) is widely used within obstetric medicine. It is used for seizure~     prevention and treatment in preeclampsia and eclampsia, and is used for fetal neuroprotection~     in preterm labor, to reduce the risk of cerebral palsy. It is well-known to have a relaxant~     effect on uterine muscle, and as such, has been used as a tocolytic agent in preterm labour~     to prevent premature contractions and premature delivery. The effect of MgSO4 on contractions~     in oxytocin pre-treated myometrium has not been fully elucidated with human lab studies.~     There are suggestions it may lead to increased oxytocin requirements or increased postpartum~     hemorrhage (PPH) in preeclamptic patients. This bears significance in the preeclamptic and~     eclamptic populations who are likely to be receiving MgSO4 in combination with oxytocin.~      The investigators hypothesize that MgSO4 will reduce uterine contractions in oxytocin~     pre-treated myometrium, as well as untreated myometrium, and higher oxytocin doses will be~     needed to produce equivalent contractions. This will help us to better understand the~     implications of the use of these drugs together in the clinical setting.~   "
70265|NCT02647255|"~     Crescentic IgA nephropathy (CreIgAN) has a poor prognosis despite aggressive~     immunosuppressive therapy. The efficacy of plasma exchange (PE) in CreIgAN is not well~     defined. This study will evaluate the efficacy and safety of plasma exchange as adjunctive~     therapy for severe crescentic IgA nephropathy compared to pulse methylprednisolone on a~     background of oral prednisolone and cyclophosphamide in prevent kidney failure.~   "
70266|NCT02647242|"~     Physical activity has demonstrated its beneficial effect on functional capabilities and~     quality of life in patients with PD. However, the daily physical activity remains limited in~     these patients. Rhythmic auditory cueing improves spatio-temporal gait parameters in patients~     with PD. The first results of BeatHealth studies have allowed us to identify the best musical~     stimulation to improve these parameters and the motivation of the patients.~      The originality of this study is to propose a gait auto-rehabilitation program using~     BeatHealth device with optimal auditory cueing during four weeks in ecological conditions in~     PD.~      Observance (utilization's time), safety (falls, pain, fatigability) and efficacy (gait~     parameters, balance, quality of life) will be evaluated.~   "
70267|NCT02647229|"~     The purpose of this physician blinded, randomized study is to determine the utility,~     effectiveness, and feasibility of using colonic irrigation as a substitute for standard oral~     colonic purgative solutions for colonoscopy preparation. Patients will be randomized to~     receive either oral isosmotic solution (PEG) or colonic irrigation using the Hydro San Plus~     Colon therapy system, an FDA approved and isosmotic (ISO) certified device for colonic~     irrigation and cleansing before endoscopic procedures.~   "
70268|NCT02647216|"~     The primary purpose of this study is to evaluate the effects of Mindfulness Based Cognitive~     Therapy (MBCT) vs. Treatment as Usual (TAU) for depression and anxiety symptoms in breast~     cancer patients in recovery. Investigators will examine whether MBCT-related improvements in~     sleep quality, illness-related distress, and rumination (escalating cycles of negative~     thinking) predict MBCT-related decreases in depression and anxiety symptoms (Aim 2).~     Exploratory analyses will examine whether demographics (e.g., age, sex, race/ethnicity),~     individual differences (e.g., perceived stress, social support), clinical characteristics~     (e.g., stage/severity of diagnosis), and treatment adherence (e.g., sessions attended, hours~     of weekly practice) help determine for whom MBCT is most effective (Aim 3).~   "
70269|NCT02647203|"~     This study aims to test the effectiveness in reducing or arresting root caries lesion in~     community-dwelling elderly subjects by using high fluoridated toothpaste. A double blinded~     RCT will be conducted with two arms; 5000 ppm F and 1450 ppm F toothpaste. Dentifrices will~     be delivered to the participants in a blind format and they will be instructed to brush twice~     per day.~      Follow-up will be carries out every 6 months for two years to assess:~        -  Root caries incidence.~        -  Lesion arresting~        -  Changes in salivary flow~        -  Microbiology pattern shift~        -  Variations in oral health- related quality of life by OHIP-14 Sp~   "
70270|NCT02647190|"~     The purpose of this study is to test the safety of Erwinia Chrysanthemi asparaginase when~     used alone and together with chemotherapy and find out what effects, if any, it has on~     people.~   "
70271|NCT02647177|"~     The purpose To determine the diagnostic potential of various biological markers in blood and~     cyst fluid aspirates from patients with Pancreatic Cystic Lesions (PCLs).~      Research design This is a 10-year prospective cohort and pancreatic cyst fluid repository~     study enrolling all patients diagnosed with pancreatic cyst and undergoing the cyst~     aspiration.~      Procedures to be used Blood Sample Cyst Fluid Sample~      Data Collection:~      Medical Record Number Demographics (age, sex, gender, race) Contact information History of~     alcohol use and IV and other recreational drugs and narcotics use/abuse Medication history~     Past hospitalizations, diagnoses, and treatment Physical examination findings Imaging data of~     abdominal and chest regions, including and not limited to ultrasonography, magnetic resonance~     imaging (MRI), computed tomography (CT) Future admissions, diagnoses, treatment including~     histopathological findings of resected specimens and blood reports End of study data:~     clinical progression of disease, cyst size, wall thickening, calcification, communication~     with pancreatic duct, string sign, cytology, immunohistochemical findings, assay levels of~     lipase, amylase CEA (carcinoembryonic antigen), carbohydrate antigen19-9 (CA 19-9), and other~     biomarkers.~      Risks and potential benefits The risks associated with this study are slight discomfort or~     bruising from the blood sampling and the possible loss of confidentiality if the patient data~     or information is inadvertently disclosed outside of this study. The patient will not receive~     any additional benefit from the study aside from those received as part of routine standard~     of care.~      Importance of knowledge that may reasonably be expected to result The knowledge gained from~     this study may benefit other patients with Pancreatic Cyst Lesions in the future.~   "
70272|NCT02647164|"~     The purpose of this study is to assess the value of circulating tumor cells (CTC)for~     non-small cell lung cancer in the postoperative recurrence monitoring by comparing the CTCs,~     CT and tumor markers at different time points.The time of CTC and carcinoembryonic~     antigen(CEA) detection is baseline, 2~7 days, 3 months, 6 months, 12 months, 24 months, 36~     months after the surgery. And the time of CT detection is 6 months, 12 months, 24 months, 36~     months after the surgery.~   "
70278|NCT02647086|"~     This is an open-label, single-sequence DDI study designed to examine the effects of dupilumab~     on the pharmacokinetics of selected cytochrome P450 substrates in adult patients with~     moderate to severe AD.~      The study consists of a screening period (day -35 to -2), study period 1 (day -1 to 7), study~     period 2 (day 8 to 50), and a follow-up period (day 51 to 135 [end of study]).~      Following completion of study period 2 (Day 50), patients will be given the option to enroll~     into the Open-Label Extension (OLE) study R668-AD-1225. Patients who decline will be followed~     for the next 12 weeks (Day 135).~   "
70279|NCT02647073|"~     Opioid dependence and its associated harms are becoming increasingly prevalent in North~     America, with overdose now being the second leading cause of accidental death in the US. This~     pilot study will investigate the feasibility of a novel mobile device to monitor vital signs~     in both opioid-injecting individuals and hospital inpatients who are on high-dose oral~     opioids. A secondary goal is to explore associations between consumption and changes in vital~     signs post-injection with the long-term goal of developing a mobile system that will alert~     clinicians when patients are at risk of overdose so that appropriate interventions can be~     delivered in time.~   "
70280|NCT02647060|"~     Pulmonary hypertension (PH) is a progressive disease with high mortality rate, but due to the~     development of drugs, the prognosis of the disease has improved. However patients still have~     poor exercise capacity and decrease of the quality of life. Past studies have shown that~     idiopathic and secondary PH are different in etiology and prognosis. It is necessary to~     further understand the difference between exercise capacity and quality of life of these two~     types of patients.~   "
70281|NCT02647047|"~     The purpose of this study is to evaluate the efficacy of spinal analgesia for minor~     laparotomic hepatectomy compared with epidural analgesia, monitoring visual analog scale~     (VAS). The investigators expect at least the same post-operative pain control in the two~     groups (non inferiority of pain control with spinal analgesia compared to epidural~     analgesia). Second endpoint is to verify whether after spinal analgesia there is a decrease~     in patient's length of hospitalization according to enhanced recovery after surgery (ERAS)~     principles.~   "
70282|NCT02647034|"~     This study investigated clinical parameters, laboratory data, imaging studies to evaluate~     patients with suspected pulmonary hypertension.~   "
70283|NCT02647021|"~     The investigators will conduct a randomized controlled trial examining 12-week, 24-week and~     one year outcomes from a combined therapeutic and physical exercise program that aims to~     bridge head-and-neck cancer survivors from acute care rehabilitation services to~     community-based exercise programming.~   "
70284|NCT02647008|"~     Aim: To compare the pain-relieving effect of a specific application of TENS vs. placebo TENS~     and a control group during unsedated diagnostic office hysteroscopy.~      Design: double-blind randomized placebo-controlled trial. Setting: Outpatient setting.~     Population: Women who attended annual gynecological check up, and were indicated for~     diagnostic office hysteroscopy.~   "
70285|NCT02646995|"~     The purpose of this trial is to evaluate if the use of a newly developed lipid formulation~     versus fish oil would better enable the absorption of essential fatty acids after 12 weeks of~     supplementation.~   "
70286|NCT02646982|"~     This study is intended to investigate the effect of candesartan, a blood pressure medication,~     on cognitive function and thinking skills in those who have early or mild memory~     difficulties, also called mild cognitive impairment or MCI.~   "
70287|NCT02646969|"~     Growth and metabolic biomarkers of healthy term infants fed formulas with staged protein~     concentrations over the first year of life~   "
70288|NCT02646956|"~     The goal of the study is to determine whether there are age-, diet- and genetically-related~     differences in the perception of sweeteners, both nutritive and non-nutritive.~   "
70289|NCT02646943|"~     BACKGROUND: Chagas Disease (ChD) remains as one of the most neglected diseases in the world,~     with 8-10 million infected people and only one marginally effective therapeutic. The lack of~     good biomarkers for active infection or clinical end-points poses a problem for assessing the~     performance of new drugs or therapeutic interventions. Among the biomarkers, several studies~     showed that Brain Natriuretic Peptide (NT-ProBNP) is accurate maker of left ventricular~     systolic and diastolic dysfunction.~      OBJECTIVE: Our long term goal is to establish The Sao Paulo-Minas Gerais Tropical Medicine~     Research Center (SaMi-Trop) as a Center of Excellence for Neglected Infectious Disease~     Research in Brazil. The Specific Aims are to begin that process by focusing on Trypanosoma~     cruzi infection with the goal of finding an array of biomarkers that correlate with parasite~     persistence and Chagas cardiac disease status that can be used to infer risk of disease~     progression and death as well used as markers of cure (parasite eradication) or clinical~     efficacy (stabilize or reverse cardiac damage) of novel drugs~      METHOD: The investigators established a prospective cohort of 1,959 patients with chronic~     Chagas cardiomyopathy (CCC). The study is being conducted in 21 cities of the northern part~     of Minas Gerais state in Brazil, and includes a follow up of at least two years (baseline and~     24 months) . The evaluation included collection of socio-demographic information, social~     determinants of health, health-related behaviours, comorbidities, medicines in use, history~     of previous treatment for Chagas Disease (ChD), symptoms, functional class, quality of life,~     blood sample collection and ECG.~   "
70304|NCT02646748|"~     This is an open-label, multicenter, Phase 1b platform study in subjects with advanced or~     metastatic solid tumors (Part 1a) and subjects with selected solid tumors (Part 1b and Part~     2). Two treatment groups (Group A and Group B) will be evaluated~      Part 1a utilizes a 3+3 design to evaluate pembrolizumab and INCB combinations in advanced~     solid tumors. Group A will evaluate a JAK inhibitor with JAK1 selectivity itacitinib~     (INCB039110) in combination with pembrolizumab (MK-3475) and Group B will evaluate a~     PI3K-delta inhibitor (INCB050465) in combination with pembrolizumab to determine the maximum~     tolerated dose (MTD) or PAD and recommend a dose for the Part 1b safety expansion with each~     combination.~      Once the recommended dose has been identified in Part 1a, subjects with select solid tumor~     types will be enrolled into safety expansion cohorts based upon prior treatment history with~     a PD-1 pathway-targeted agent (Part 1b) for each combination.~      Part 2 utilizes a Simon 2-Stage design to evaluate INCB050465 in combination with~     pembrolizumab in patients with small cell lung cancer (SCLC) and a 1 stage design to evaluate~     the combination in patients with non-small cell lung cancer (NSCLC) and urothelial cancer~     (UC).~   "
70290|NCT02646930|"~     Background: Embryo quality is known to be a very important determinant to predict the~     implantation and pregnancy rate in IVF patients, however, the role of uterine integrity or~     endometrial receptivity cannot be overlooked.~      Chronic endometritis (CE) is an inflammation of the endometrium diagnosed by the presence of~     plasma cells in the endometrial stroma. There is not only no census on the definition of CE,~     the current literature on the impact of CE on reproductive outcome is controversial and~     consists only of retrospective studies with small sample sizes. Although there is a~     presumption that CE is related to poor IVF outcome, this belief has not been proven.~      Design: Prospective cohort study~      Setting: Infertility clinics of 2 academic medical centers~      Patients: Patients between the ages of ≥ 21 and ≤ 35 years old undergoing their first IVF~     cycle will be invited to participate.~      Main Outcome Measures: The primary outcome will be ongoing pregnancy after 12 weeks estimated~     gestational age (EGA) with previously documented fetal cardiac motion. Secondary outcomes~     will include pregnancy loss rate as defined by chemical pregnancy, blighted ovum or loss of~     fetal cardiac motion before 12 weeks EGA.~      Materials and Methods: The cycle prior to IVF, patients will undergo an in-office endometrial~     biopsy on cycle days 19-24. Samples will be stained for CD138 and the number of plasma cells~     will be quantified. The number of plasma cells in a sample that yields the best sensitivity~     and specificity for pregnancy will be determined by a Receiver-Operator-Curve. This number~     will then be used as a dichotomous variable to assign categories of positive for CE and~     negative for CE. Pregnancy and miscarriage rates will then be determined in the positive~     and negative CE sample with Chi Square Analysis. A secondary sub analysis will be performed~     to determine pregnancy and miscarriage rates in patients who declined to participate in the~     study.~      Expected Results: The investigators hypothesize that higher rates of CE will be found in~     women failing to conceive with IVF and with subsequent first-trimester miscarriage.~   "
70291|NCT02646917|"~     This single-center, clinical trial will take place over a 90 day course followed by 1-month~     and 6-month post treatment visits to assess the efficacy and tolerability of the SkinPen~     device when used on both men and women on the face and/or back.~   "
70292|NCT02646904|"~     The purpose of this study is to examine in children with persistent AR the effect of the~     topically applied beclomethasone in comparison with cetirizine on nasal patency evaluated by~     acoustic rhinometry and subjective nasal symptoms.~   "
70293|NCT02646891|"~     This is is a study of a parenteral trivalent rotavirus vaccine (P2-VP8 subunit rotavirus~     vaccine). The study will examine the safety and immunogenicity of three dose levels of this~     vaccine in healthy South African adults, toddlers and infants. Progression from one dose~     level to another and to the next age group population will be based on the assessment of~     safety information from the lowest dose and older age group.~      The primary safety hypothesis is that the P2-VP8 subunit rotavirus vaccine is safe and~     well-tolerated. The primary immunogenicity hypothesis is that the trivalent P2-VP8 subunit~     rotavirus vaccine is immunogenic in infant participants and will induce an immune response to~     at least 2 of the 3 strains in 60% or more of participants in at least one of the study~     groups.~   "
70294|NCT02646878|"~     The purpose of this study is to demonstrate the performance of the Harmony 1 Sensor in~     subjects age 14 - 75 years.~   "
70295|NCT02646865|"~     This study evaluates the addition of a self-compassion training in the treatment of social~     anxiety disorder. Half of the participants will receive a self-compassion enhanced group~     cognitive-behavioral therapy, while the other half will receive standard group~     cognitive-behavioral therapy.~   "
70296|NCT02646852|"~     This is a Phase I, two-stage, open-label, single-arm, dose escalation study of DFP-13318~     intravenous infusion administered to patients with refractory or relapsed solid tumors. This~     study will explore two different dosing schedules- once every 3 weeks (q3w) and once every 2~     weeks (q2w) - during Stage 1 and Stage 2, respectively.~   "
70297|NCT02646839|"~     This is a phase II, open-label, non-randomized, prospective study of haploidentical~     transplantation using KIR-favorable donors for children with acute lymphoblastic leukemia~     (ALL), acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) undergoing allogeneic~     hematopoietic cell transplantation (HCT). The relationship of KIR2DL1 polymorphisms to~     survival in children with these diseases undergoing any approach to allogeneic HCT during the~     study time frame will also be determined.~   "
70298|NCT02646826|"~     This is a multi-center, double-blind, placebo-controlled study with two weeks of daily oral~     administration of one of three dose levels of Paxerol or placebo in subjects with nocturia.~     Eligible study subjects will be identified according to inclusion/exclusion criteria (see~     below), and baseline assessments will be recorded.~      Due to small sample size of 25 patients per group in this proof-of-principle dosing-finding~     trial, stratification according to gender and BMI will be difficult. However, similar~     distribution of patient types to the four treatment groups will be attempted by evenly~     assigning patients to the four treatment groups according to genders and body mass index~     (BMI) of <25, 25-30 and 30-40.~      Paxerol or placebo will be taken 30 minutes before bedtime daily for two weeks. Nocturia~     frequency, Nocturia Quality of Life (NQOL), Duration of First Undisturbed Sleep (DFUS), total~     hours of nightly sleep, safety and tolerability will be monitored before and after a two-week~     treatment period. Results from subjects treated with different doses of Paxerol and placebo~     will be assessed and compared. Baseline urinary Prostaglandin E2 (PGE2) production will also~     be assayed to assess potential correlation between baseline urinary PGE2 production and~     responsiveness to Paxerol treatment.~   "
70299|NCT02646813|"~     The objective of this study is to evaluate the time and ease of placement of an extra-luminal~     Arndt bronchial blocker versus placing it intra-luminally.~      An additional objective will be to assess if there are any other significant clinical~     differences between these two approaches to placement of the BB including overall quality of~     isolation, an increase in post-operatives sore throat, post-operative hoarseness, and~     increased incidence of needing to reposition the blocker~   "
70300|NCT02646800|"~     The objective of this study is to evaluate the safety and efficacy of intravenous micafungin~     for the treatment of adult patients in China infected by Candida spp or Aspergillus spp.~   "
70301|NCT02646787|"~     Using virtual reality as a form of distraction during a painful burn wound care procedure in~     addition to pain medication.~   "
70302|NCT02646774|"~     The objective of this study is to evaluate the efficacy and safety of intravenous micafungin~     for the treatment of proven or probable fungal infections caused by Aspergillus sp.~     (Fungemia, respiratory mycosis, gastrointestinal mycosis) in adult patients in China.~   "
70303|NCT02646761|"~     The purpose of this study is to determine if home-based therapy with monitoring via~     telemedicine can overcome many barriers to compliance and improve rehabilitation. Patients~     undergoing total knee arthroplasty will be followed for 10 weeks during their outpatient~     physical therapy course. Subjects will undergo standard physical therapy or physical therapy~     paired with InterACTION for 10 weeks.~   "
70306|NCT02646722|"~     Rocuronium results in burning pain on injection site. It can be reduced by local anesthetics~     or opioid, but still some patients, especially in children, show withdrawal movement for~     pain. This might resulted from individual pain sensitivity.~      Emergence agitation (EA) in children is quite frequent postoperatively and is known to be~     associated with postoperative pain. If a patient is susceptible to postoperative pain, he or~     she would have high probability of EA postoperatively. Therefore, the investigators explore~     the relation of withdrawal movement of rocuronium and EA.~   "
70307|NCT02646709|"~     Rocuronium is suitable for rapid induction within 60-90 seconds and its effect last 24-40~     minute after single bolus injection. For outpatient surgery with short operation time, low~     dose rocuronium is frequently used for rapid recovery at the expense of compromised~     intubating condition. For better intubating condition, ketamine can be used. However,~     appropriate dose of ketamine with low dose rocuronium is not established yet. This study, 3~     different doses of ketamine with low dose rocuronium will be compared for appropriate~     intubating condition.~   "
70308|NCT02646696|"~     The purpose of this study is tTho establish test-retest reliability of electrodermal markers~     used to quantify physiologic response to sensation using the Sensory Challenge Protocol in~     children with and without Autism Spectrum Disorder (ASD).~   "
70309|NCT02646683|"~     This multi-centre open label study will involve a minimum of 260 patients in 2 cohorts: 130~     patients with 'early CD' defined as disease duration < 24 months and no other treatments than~     corticosteroids and 130 patients with 'late CD' defined as active disease despite treatment~     with immunosuppressives and anti-TNF. Patients with intolerance to IS and anti-TNF will also~     be allowed in the latter group. Participants will be treated with 12 months of open label~     vedolizumab (study medication followed by commercial medication once reimbursement is~     available) and undergo monitoring of endoscopic, histological and clinical disease~     parameters. No randomization or blinding will be performed but the study management will~     ensure that recruitment in either study group is comparable for number and profile of~     patients (on/off steroids).~   "
70310|NCT02646670|"~     The purpose of this study in to compare the efficacy of treatment of diabetic macular edema~     (DME) using Ranibizumab (Lucenti®), Aflibercept (Eylea®) and Aflibercept (Eylea®) plus~     Ranibizumab (Lucentis®).~      It is a randomized clinical trial that will evaluate the efficacy of the combination of two~     substances currently used in the treatment of DME. Will be allocated in different four groups~     randomly pacients who receive treatment with intravitreal injections of ranibizumab,~     aflibercept or a combination of aflibercept and ranibizumab.~   "
70311|NCT02646657|"~     This multi-centre open label study will involve a minimum of 120 patients in 2 cohorts: 60~     patients with 'early UC' defined as disease duration < 4 years and no other treatments than~     aminosalicylates and/or corticosteroids and 60 patients with 'late UC' defined as active~     disease despite treatment with immunosuppressives (IS) and/or anti-TNF. Patients wih~     intolerance to IS AND anti-TNF will also be allowed in the latter group. Participants will be~     treated with 12 months of open label vedolizumab and undergo monitoring of endoscopic,~     histological and clinical disease parameters. No randomization or blinding will be performed~     but the study management will make sure recruitment in either study group is comparable for~     number and profile of patients (extent of disease and on/off corticosteroids).~   "
70312|NCT02646644|"~     In an individual cancer patient extensive genetic and phenotypic variation exists between and~     within tumor lesions. Tumour load in NET patients can be measured with~     fluorine-18-L-dihydroxyphenylalaninepositron emission tomography (18F-DOPA-PET) scan.~      This aim of the study is to investigate heterogeneity between tumor lesions within patients~     with intestinal NET by determining the differences in tracer uptake measured on a 18F-~     DOPA-PET scan retrospectively.~   "
70313|NCT02646631|"~     The long-term goal of this research is to improve seizure control among patients with~     epilepsy, which has the potential to improve quality of life for thousands of people living~     with epilepsy and reduce health care utilization, social and economic costs, and~     epilepsy-related mortalities. Participants who are suffering from epilepsy will be randomized~     to receive usual care (UC), a smartphone-based self-management intervention called Management~     of Risks in Epilepsy (MORE), or MORE + telephone-based motivational interviewing (MI).~     Participants will be followed for 3 months.~   "
70314|NCT02646618|"~     The present study is a non-inferiority trial comparing the efficacy of a lifestyle~     intervention delivered entirely via an online social network to a traditional lifestyle~     intervention delivered via group meetings.~   "
70315|NCT02646605|"~     Quantitative, validated tools of depression screening will be used to collect data to~     determine the prevalence of depression and its association with antiretroviral (ARV)~     adherence amongst HIV positive patients attending ART clinic at Lighthouse Lilongwe, Malawi.~   "
70316|NCT02646592|"~     This study aims to assess the Pupillary Pain Index before and after a bolus of alfentanil in~     children under general anesthesia, before skin incision.~   "
70317|NCT02646579|"~     The purpose of this study is to determine if dry needling both low back and extremity areas~     is more effective for reducing pain and improving strength, balance and functional~     performance among patients with chronic musculoskeletal conditions compared to dry needling~     of extremity areas only.~   "
70318|NCT02646566|"~     Double-blind, randomised, parallel-group, placebo-controlled, adaptive, seamless,~     dose-selecting study to compare the efficacy of APD421 to placebo as treatment of established~     PONV, in patients who have had prior PONV prophylaxis.~   "
70319|NCT02646553|"~     Cortisol overproduction ( Cushings syndrome) is a condition where the patient have a special~     fat distribution, with accumulation of fat around the abdomen and in the neck, with thinner~     limbs and weak musculature. The condition can be difficult to separate from adipositas in~     general. Screening for hypercortisolism in adults has been easier the last years, because we~     can measure free cortisol in saliva samples at late night. In children we still dont have~     reference ranges for saliva cortisol in children, so the screening is still troublesome,~     based on Collection of 24-hour urine.The meaning of this study is to establish reference~     ranges for saliva cortisol, and evaluate in a cohort with adipose children if screening with~     saliva cortisol is sensitive and specific enough to be the New screening test for~     hypercortisolism in children too.~   "
72996|NCT02611505|"~     The purpose of this study is to evaluate the pharmacokinetics, safety, and tolerability of~     intranasally administered esketamine in both participants with varying stages of hepatic~     impairment and healthy participants.~   "
70320|NCT02646540|"~     The purpose of this study is to test the use of tolvaptan (commercial name Samsca) when given~     in addition to intravenous (IV) diuretics early during an episode of acute heart failure. It~     will be compared to a high dose of IV diuretics alone or the use of metolazone in addition to~     IV diuretics. The investigators are looking to see if there is improvement in the symptoms~     and outcomes of persons with acute heart failure.~   "
70321|NCT02646527|"~     Background: There has been significant progress in symptom management, pain relief and~     improvement of quality of life in patients nearing death by implementing palliative care~     programs. Existential and dignity related issues, such as loss of autonomy and sense of~     meaning or feeling a burden to others are frequent reasons for psychological distress and~     desire for hastened death. Dignity Therapy (DT), developed by Chochinov et al., is a brief,~     individualized psychotherapy for the purpose of relieving distress by directly addressing~     dignity conserving factors.~      Aims: To test whether the inclusion of a patient's partner or designated family member into~     Dignity Therapy (DT+) could mitigate psychological distress (anxiety and depression) in both,~     the patient nearing the end of his life experiencing increased psychological distress and the~     patient's partner/family member compared to the control groups receiving Dignity Therapy in~     the single setting (DT) or standard palliative care (SPC).~      Methods and design: In this randomized controlled trial a total of 159 patients with a~     diagnosis of an advanced disease and poor prognosis (life expectancy < 6 months) who receive~     palliative care either in the Palliative Care Centre of the University Hospital Zurich (USZ)~     or the Clinic Susenberg, Zurich, or in the Lighthouse Hospice Zurich, will be randomly~     assigned to either DT+, DT, or SPC in a 1:1:1 ratio. Patients will be pre-screened and~     included if they report increased psychological distress (anxiety, depression using the~     Hospital Anxiety and Depression Scale=HADS). The therapy is guided by trained therapists and~     consists of 3 audiotaped sessions. The main focus of the intervention is to invite patients~     to reflect on their most important achievements, roles or other things in their lives or~     things that they would most want remembered. On completion, the audiorecording is transcribed~     and edited to provide a clear and readable narrative, the generativity document, which can be~     passed to a person of the patient's choice. DT+, in contrast to the original intervention~     developed by Chochinov et al., is a systemic approach in which patient's partners or~     designated family members are included.~   "
70322|NCT02646514|"~     Malignant obstructive jaundice is a common complication of advanced stage cholangiocarcinoma,~     gallbladder cancer, and pancreatic cancer. In biliary stricture by malignancy, biliary~     drainage with placement of self-expanding metal stent (SEMS) for palliation is the therapy of~     choice in these patients. When compared to plastic stents, SEMS present a significantly~     decreased risk of recurrent biliary obstruction. SEMS are also more cost-effective than~     plastic stents in patients with a life expectancy of longer than 4 months. However, despite~     their numerous benefits, SEMS become occluded in up to 50 % of patients in the first 6-8~     months.~      Radiofrequency ablation (RFA) has been used to treat malignancies of the liver since the~     early 1990s. Other studies have investigated its role in diseases of the colon and esophagus.~     More recently, this technique has been recognized for its potential in palliative treatment~     of malignant biliary strictures. RFA uses a high-frequency alternating current to generate~     heat and achieve coagulative necrosis when in contact with tissue. Within the bile duct, RFA~     appears to be safe and may result in decreased benign epithelial hyperplasia and tumor~     ingrowth. However, RFA along with placement of SEMS has not been well studied. On the other~     hand, newly developed RFA catheter (ELRA®) showed the feasibility and safety in south korea,~     recently.~      The purpose of this study was to investigate the Efficacy and safety of endobiliary RFA by~     using a novel RF catheter (ELRA®) on maintaining the patency of endobiliary metal drainage in~     patients with malignant biliary strictures.~   "
70323|NCT02646501|"~     The investigators will compare the effects of PSGB(percutaneous stellate ganglion block) in~     patients with recurrent sustained VT/VF in spite of appropriate medical therapy and~     cardio-version/ defibrillation after correction of underlying correctable factors with those~     without PSGB by prospective randomized trail. PSGB will be performed every 3 days by~     anesthesiology specialist after cardiologist's request, until the stabilization of VT/VF. We~     will compare the frequency and episode number of VT/VF, procedure related complication, acute~     and long-term mortality.~   "
70324|NCT02646488|"~     The primary purpose of this study is to evaluate the effectiveness of practice facilitation~     as a quality improvement strategy for implementing the Million Hearts' ABCS treatment~     guidelines for reducing cardiovascular disease (CVD) among high-risk patients who receive~     care in primary care practices in New York City. The ABCS refer to the following: Aspirin in~     high-risk individuals (A), Blood pressure control and management (B), Cholesterol management~     (C), and Smoking cessation (S). The long-term goal is to create a robust infrastructure to~     disseminate and implement evidence based practice guidelines (EBPG) findings in primary care~     practices and improve practices' capacity to receive and implement other EBPG findings in the~     future.~   "
70325|NCT02646475|"~     The overall purpose of this study is to learn more about the metabolic effects of~     angiotensin-(1-7) in the insulin resistant state associated with obesity. Pharmacologic~     approaches to increase angiotensin-(1-7) levels or its actions are currently in development~     for treatment of metabolic-related diseases such as obesity and type II diabetes, based on~     findings from animal studies. It is unclear if this peptide contributes to the regulation of~     metabolism in humans. The investigators will test if angiotensin-(1-7) infusion can improve~     insulin sensitivity measured by hyperinsulinemic-euglycemic clamp methods in individuals with~     obesity and insulin resistance. The investigators will also examine for changes in blood~     pressure and related hemodynamic and hormonal changes following angiotensin-(1-7) infusion.~   "
70326|NCT02646462|"~     Prospective investigation of the ratio between malignant and total number of lymph nodes in~     predefined lymph node stations in patients resected for pancreatic adenocarcinoma. A national~     Danish project.~   "
70327|NCT02646449|"~     Recent reports have shown that alcohol misuse is a particularly serious problem among the 18~     to 25 year old age group. Previous medication trials with SSRI antidepressants among young~     adults with co-occurring depressive disorders, including our own recent trials with SSRI~     medications, have produced disappointing results, especially for decreasing the level of~     alcohol consumption. Mirtazapine is a non-SSRI medication with a unique structure and~     mechanism of action. Recent study results suggest that mirtazapine is more effective than~     other antidepressants for treating non-comorbid depression. A few recent studies with~     mirtazapine have been conducted among subjects with comorbid AUD/MDD, and those studies have~     demonstrated efficacy for mirtazapine for decreasing the depressive symptoms and the alcohol~     craving of subjects with comorbid AUD/MDD. However, those studies did not measure level of~     alcohol consumption, so it is unclear whether mirtazapine decreases the level of alcohol use~     of that comorbid population. The results of our own very recent open label pilot study~     suggest robust within-group efficacy for mirtazapine for decreasing both the level of alcohol~     use and the depressive symptoms of comorbid subjects. However, that pilot study did not~     include a placebo control group, so the efficacy of mirtazapine versus placebo for decreasing~     the level of alcohol use among persons with comorbid AUD/MDD remains unclear. This grant~     submission proposes to conduct a first double-blind, placebo-controlled pilot study to~     provide a preliminary assessment of the efficacy of mirtazapine versus placebo for decreasing~     both the alcohol use and depressive symptoms of young adults with comorbid AUD/MDD. If~     results (effect sizes) from the proposed study are found to be promising concerning outcome~     differences between the mirtazapine and placebo groups, then we will use those findings to~     apply for an R01 study to definitively assess the efficacy of mirtazapine for treating young~     adults with AUD/MDD.~   "
71612|NCT02629575|"~     Postmarket surveillance in terms of the safety and efficacy of Sirolimus-eluting Coroflex~     ISAR Stent for the treatment of real world patients with de-novo and restenotic lesions~     after stand-alone angioplasty in coronary arteries~   "
70328|NCT02646436|"~     Peritoneal dialysis (PD) has become a well-established complementary alternative to~     haemodialysis (HD) as first-line renal replacement modality. At department of Botucatu~     Medical School, more than 60% of the chronic kidney disease (CKD) stage 5 patients are~     started urgently on chronic dialysis due to late referral or unexpected deterioration of~     residual renal function. These patients, although suitable for PD, were previously started on~     HD using central venous catheter. Since July 2014 patients have been offered urgent start on~     chronic PD right after PD-catheter insertion by percutaneous surgery, using Seldinger~     technique. The main objective is to compare technique and patients survival on unplanned PD~     vs. unplanned HD in the first 180 days. Methodology: Quasi experimental study which will~     describe how acute PD will initiated using high volume PD until metabolic and fluid control~     right after (<48 h) PD catheter placement standard prescription for a 12 h overnight~     automatic PD until hospital discharge and intermittent PD at dialysis unit family training.~   "
70329|NCT02646423|"~     Cesarean delivery (CD) is the most common inpatient surgery in the US, accounting for nearly~     one third of births annually. In the last decade, the CD rate has increased by approximately~     50%, with almost 1.3 million procedures performed in 2012 (Hamilton 2013). CDs have been~     associated with an increase in major maternal morbidity (Silver 2010), with corresponding~     increases in length of inpatient care following delivery and frequency of hospital~     readmission (Lydon-Rochelle 2000). Organizations including Healthy People, the American~     College of Obstetricians and Gynecologists (ACOG), and the American College of Nurse Midwives~     have targeted reducing the CD rate as an important public health goal for more than a decade;~     however, identifying interventions to achieve this goal has proven challenging.~      Repeat CDs are a significant contributor to the increased cesarean rate, resulting from the~     combination of a rising rate of primary CD and a decreasing rate of vaginal birth after~     cesarean (VBAC), which declined from a high of 28.3% in 1996 (Guide 2010) to 9.2% in 2010~     (Hamilton 2011). Why the VBAC rate has decreased so dramatically remains a subject of debate;~     the extent to which these changes are driven by patient preferences is not known. An NIH~     consensus conference statement noted that the informed consent process for TOLAC and~     Elective Repeat Cesarean Delivery (ERCD) should be evidence-based, minimize bias, and~     incorporate a strong emphasis on the values and preferences of pregnant women, and~     recommended interprofessional collaboration to refine, validate, and implement~     decision-making and risk assessment tools to accomplish that goal (Cunningham 2010).~      Our group recently created a decision tool, which we refer to as the Prior CD App (PCDA), to~     help English- or Spanish-speaking TOLAC-eligible women delivering at hospitals that offer~     TOLAC consider individualized risk assessments, incorporate their values and preferences, and~     participate in a shared decision making process with their providers to make informed~     decisions about delivery approach. We are now conducting a randomized study of the effect of~     a Prior CD App on TOLAC and VBAC rates, as well as a number of aspects of decision quality.~   "
70330|NCT02646410|"~     Based in part on the pivotal studies conducted in Mali, SMC was approved by WHO as a policy~     for malaria control in countries with seasonal malaria transmission such as Mali in March~     2012. The goals are to identify the most effective method to deliver SMC, and to obtain more~     information on the long term impact of SMC on malaria immunity. Our specific aims are 1) to~     determine the optimal mode (fixed-point (FPD) vs door-to-door delivery (DDD); directly~     observed treatment (DOT) vs non-DOT (NDOT)) and frequency (3 vs 4 doses per season) of SMC~     delivery; 2) to compare quantitative measures of immunity in children who do and do not~     receive SMC. A cluster-randomized design will be sued. The target population will be children~     aged 3-59 months old in Ouelessebougou district, Mali. In Year 1, villages in four~     sub-districts will be randomized into four groups (FPD+DOT; FPD+NDOT; DDD+DOT; DDD+NDOT). The~     optimal mode of delivery will be selected based on the SMC coverage during the first year,~     and will then be implemented in villages of two additional sub-districts. Villages in these~     two newly selected sub-districts will be randomized in two groups. Children in the first~     group will received three rounds of SMC and those in the second group will receive four~     rounds of SMC to determine the optimal frequency of SMC based on the incidence rate of~     clinical malaria as measured by passive surveillance. In Year 3, children in the selected~     sub-districts will received SMC by the optimal delivery system determined in Years 1 -2. A~     survey will be conducted collect data on mortality and hospital admission and compare these~     outcomes in areas where SMC was implemented and areas where SMC was not implemented.~   "
70331|NCT02646397|"~     The purpose of this study is to compare the effect of fosinopril plus benidipine vs.~     fosinopril plus hydrochlorothiazide on the renal function during the 6-month treatment in CKD~     patients with HTN.~   "
70332|NCT02646384|"~     The Institutional Review Board (IRB) protocol is being designed to offer ovarian tissue~     cryopreservation to female pediatric patients (birth-17 years of age) with fertility~     threatening medical diagnoses or facing surgery, chemotherapy or radiation therapy that may~     cause loss of reproductive potential. Because this procedure is currently considered~     experimental, the establishment of an IRB protocol under which this opportunity can be~     offered is needed.~   "
70333|NCT02646371|"~     In this proof of concept challenge study, the bioconjugate candidate vaccine Flexyn2a will be~     tested for its ability to induce an immune response that protects healthy adult volunteers~     from infection with a wild-type Shigella flexneri 2a strain compared to subjects receiving~     placebo.~   "
70334|NCT02646358|"~     This is an open-label study designed to evaluate the effect of renal disease on the~     pharmacokinetics of vepoloxamer relative to the pharmacokinetics in healthy subjects with~     normal renal function.~   "
70335|NCT02646345|"~     Limited information is available about surgical checklist effectiveness in Latin America. We~     plan to compare the pre and post surgical checklist implementation in a tertiary healthcare~     center in terms of morbidity (length of stay and surgical site infection rate) and~     in-hospital mortality rate.~   "
70336|NCT02646332|"~     Reverse hybrid therapy achieves a higher eradication rate than concomitant therapy remains~     unanswered.~   "
70337|NCT02646319|"~     This pilot phase II trial studies how well nanoparticle albumin-bound rapamycin works in~     treating patients with cancer that as has spread to other places in the body and usually~     cannot be cured or controlled with treatment (advanced cancer) and that has an abnormality in~     a protein called mechanistic target of rapamycin (mTOR). Patients with this mutation are~     identified by genetic testing. Patients then receive nanoparticle albumin-bound rapamycin,~     which may stop the growth of cancer cells by blocking the mTOR enzyme, which is needed for~     cell growth and multiplication. Using treatments that target a patient's specific mutation~     may be a more effective treatment than the standard of care treatment.~   "
70338|NCT02646306|"~     The aim of the study focused on the creation of a rehabilitative measuring device~     (SRPT-shoulder proprioceptive rehabilitation tool) and the development of the examination~     methodology for assessing the proprioception of the glenohumeral joint respect to scapula~     abduction, within the movement of antepulsion on the sagittal plane both in healthy subjects~     and in patients with shoulder impingement syndrome.~   "
70339|NCT02646293|"~     The incidence of the diagnosis of renal cell carcinoma has increased during the past two~     decades because of the detection of small renal tumours that occur incidentally because of~     increased use of CT-scanning (1,2). Postoperative renal insufficiency was a significant~     independent predictor of overall and cardiovascular specific survival (3). Nephron-sparing~     surgical techniques are now preferred for small tumor masses and laparoscopic intervention is~     replacing open surgery at centers that master this technique. This is an area of priority~     within the Regions of Zaeland and Southern Denmark.~      The primary endpoint is:~      The early plasma (5 days) [NT-proBNP] response predicts long-term total renal function and~     function of the remaining kidney.~      The second endpoint:~      Plasma [NT-proBNP] increases acutely after partial nephrectomy and the change reflects the~     renal mass reduction.~      Chronic blood pressure change is inversely related to plasma [BNP].~   "
70340|NCT02646280|"~     The purpose of the study is to determine the effectiveness of an approach that combines~     massage therapy with elements of neurocognitive rehabilitation such as motor imagery and the~     words of the physiotherapist compared to a traditional massage therapy in reducing pain in~     patients with chronic low back pain (CLBP) and to evaluate if and how the pain reduction is~     linked to the interoceptive awareness and which is the patient's ability to relax through the~     measurement of the hearth rate variability (HRV).~   "
70341|NCT02646267|"~     The purpose of this trial is to demonstrate the efficacy and safety of dabigatran etexilate~     and different intensity warfarin for the prevention of stroke and systemic embolism in~     patients with non-valvular atrial fibrillation.~   "
70342|NCT02646254|"~     Myocardial protection and clinical outcome in patients Undergoing tetralogy of fallot repair:~     a randomized study of Two cardioplegic techniques.~   "
70343|NCT02646241|"~     To increase the diagnostic accuracy of subepithelial tumors, larger tissue samples are~     required. It is difficult to obtain adequate tissue samples. There were several biopsy~     methods to obtain tissue samples. Pathological examination would include mitosis counts,~     particularly in hypoechoic subepithelial tumors located in the 4th layer of the gastric wall,~     where differentiation between leiomyoma of benign nature and gastrointestinal stromal tumor~     (GIST) of malignant potential is essential.~      So We hypothesize that unroofing biopsy is an more appropriate method than EUS-FNB(endoscopic~     ultrasonography guided fine needle biopsy). We will compare diagnostic accuracy and~     complications between EUS-FNB & unroofing biopsy.~   "
70344|NCT02646228|"~     With rapid advances in molecular oncology, the availability of preclinical in vitro cell~     models and in vivo animal models with specific genomic aberrations is critical for improved~     prediction of clinical outcomes in cancer patients. One of the most widely used preclinical~     models is conventional cell lines, such as the NCI-60 panel of cell lines;these cell lines~     are widely used in preclinical testing for novel targeted drugs, partially owing to the low~     expense and reduced labor associated with cell culture compared with other preclinical~     models, such as animal xenografts. However, recent studies have shown that accumulation of~     genetic aberrations in cancer cell lines occurs with increasing passage number. These models~     also lack the heterogeneity of tumors and do not exhibit a proper microenvironment,~     highlighting the limitations of cell-based models. Consistent with this, Johnson et al.~     demonstrated that in vivo activities of the cell lines within the NCI-60 panel did not~     closely correlate with corresponding human cancers.~      Therefore, to better preserve the genomic integrity and tumor heterogeneity observed in~     patients, patient-derived xenograft (PDX) models are being used more frequently. PDX is~     generated by directly transplanting freshly resected patient tumors into immunocompromised~     murine hosts with or without an intermediate in vitro culture step. This PDX model is an~     improvement over cell lines because it can provide both an appropriate tumor microenvironment~     and heterogeneity of tumor cells. However, the engraftment success rates and growth rates of~     implanted tumors are highly variable depending on the tumor type, possibly due to~     insufficient numbers of hematopoietic cells and/or ineffective microenvironmental cues in the~     mouse stroma. The extent to which tumor cells from freshly resected tumors are able to~     withstand mechanical stresses and xenotransplantation barriers is also unclear. Furthermore,~     the use of PDX models for application in clinical oncology is limited owing to the time~     required for PDX establishment (> 4 months) since most patients with refractory cancer live~     less than 1 year. Recently, PDC line models have been suggested as an alternative preclinical~     model to be used as a prediction tool for preclinical drug sensitivity.~      Therefore, in this study, the investigators aimed to overcome these potential barriers of~     pre-existing models by examining the capacity of PDC line models to recapitulate the~     histological and genomic features of primary patient tumors. In selected cases, the~     investigators screened drug sensitivity in vitro using PDC lines and compared the results~     with real-life clinical treatment outcomes.~   "
70345|NCT02646215|"~     Evaluation of the effect of inspiratory muscle training in Ehlers Danlos patients~   "
70346|NCT02646202|"~     Gastric varices occur in 5-33% of patients with portal hypertension. Concomitant gastro~     esophageal varices are the most common type. Both endoscopic sclerotherapy and band ligation~     are very effective in controlling acute esophageal varices bleeding and preventing~     rebleeding.~   "
70347|NCT02646189|"~     REP 9AC (REP 2055) is a nucleic acid polymer (NAP) with entry and post-entry antiviral~     activity against duck hepatitis B virus (DHBV) infection. REP 2055 has been shown to have~     potent therapeutic effect against established DHBV infection in vivo~      REP 2055 was additionally shown to have significant antiviral effects in patients with~     chronic HBV infection in the previous REP 101 study. REP 2139 is a version of REP 2055~     designed for improved administration tolerability and stability.~      The safety and antiviral activity REP 2139, first in monotherapy and then in combination with~     immunotherapy in patients with chronic HBV infection will be assessed in the REP 102~     protocol.~   "
70348|NCT02646176|"~     Traumatic brain injury (TBI) is increasingly recognized as a significant public health issue,~     but the most effective rehabilitation methods have yet to be identified. The Institute of~     Medicine and the Agency for Healthcare Quality and Research sponsored systematic reviews of~     evidence for comparative effectiveness of rehabilitation interventions for TBI. Both reviews~     concluded that substantially more research is needed to identify interventions best suited~     for different individuals. The practice-based evidence (PBE) approach employed to create the~     data used in the proposed study was a research method recommended to provide greater clarity,~     along with use of patient-centered outcomes obtained over a longer period of time than used~     in previous studies.~      The following specific aims will be addressed in the proposed study:~        1. Determine the comparative effectiveness of different therapeutic approaches used in~          inpatient TBI rehabilitation after statistically adjusting for patient need and ability~          to benefit from various approaches.~           Investigators hypothesize:~           1.1. Patients who receive a greater proportion of therapy time in Advanced Training~          (versus Standard of Care) will achieve better outcomes than similar patients who receive~          a lesser proportion of treatment time in Advanced Training.~           1.2. Patients with the greatest initial levels of disability will experience larger~          effects from Advanced Training therapeutic approaches in comparison to the effects~          experienced by patients with less disability at admission.~           1.3. Patients who receive a greater proportion of therapy in contextualized treatment~          (versus decontextualized) will achieve better outcomes than similar patients who receive~          a lesser proportion of time in contextualized treatment.~        2. Determine the comparative effectiveness of difference in the delivery of inpatient~          rehabilitation therapies, after statistically adjusting for patient need and ability to~          benefit.~      Investigators hypothesize:~      2.1 The level of effort that patients are able to apply in treatment moderates the~     effectiveness of time in treatment.~      2.2 Family involvement in treatment is associated with better outcomes.~      Data will be drawn from the database established for the TBI Practice-Based Evidence Study~     (TBI-PBE Study). Data on 2130 persons who received inpatient TBI rehabilitation at any of 10~     sites (9 in US, 1 in Canada) were obtained for the study. Detailed longitudinal data were~     collected prospectively on rehabilitation therapies (with point of care data completed for~     every clinical encounter), course of recovery, person and injury characteristics and outcomes~     during and after rehabilitation. Advanced analytic methods (e.g. propensity scores,~     generalized linear mixed models) will be used to compare the effects of different~     rehabilitation interventions on outcomes at discharge and during the 9 months following~     rehabilitation.~   "
70349|NCT02646163|"~     REP 9AC (REP 2055) is a nucleic acid polymer (NAP) with entry activity against hepatitis C~     virus and entry and post-entry antiviral activity against duck hepatitis B virus (DHBV)~     infection. REP 2055 has been shown to have potent prophylactic effect against HCV infection~     in vivo and potent therapeutic effect against established DHBV infection in vivo~      The REP 101 protocol is the first-in-man proof of concept study designed to investigate the~     safety and antiviral activity of REP 2055 administration in human patients with chronic HBV~     or HCV infection.~   "
70350|NCT02646150|"~     This study evaluates the clinical effectiveness of Magnetic Resonance(MR) perfusion imaging~     to qualitatively assess adequate distal perfusion after endovascular revascularization in~     Critical Limb Ischemia~   "
70351|NCT02646137|"~     Hepatocellular carcinoma is the third most common cause of cancer-related mortality. In~     recent years, transarterial chemoembolization, radio frequency ablation and microwave~     ablation have been accepted as treatment modalities for patients with surgically unresectable~     hepatocellular carcinoma.~   "
70352|NCT02646124|"~     Low back pain (LBP) causes 2.4% of visits to US emergency departments (ED) resulting in 2.7~     million visits annually. In general, outcomes for these patients are poor. One week after ED~     discharge, 70% of patients report persistent back-pain related functional impairment and 69%~     report analgesic use within the previous 24 hours. Three months after the ED visit, 48% of~     these patients report functional impairment, 42% report moderate or severe pain, and 46%~     report persistent analgesic use.~      It is not clear how acute LBP should be treated. Non-steroidal anti-inflammatory drugs~     (NSAID) are guideline-supported, first line therapy for acute LBP. NSAIDs are more~     efficacious than placebo with regard to pain relief, global improvement, and requirement of~     analgesic medication but are not sufficient therapy for as many as ½ of ED patients, who~     continue to suffer despite therapy with NSAIDs. Treatment of LBP with multiple concurrent~     medications is common in the ED--emergency physicians often prescribe benzodiazepines,~     skeletal muscle relaxants, or opioids in combination with NSAIDs. However, work recently~     completed here at Montefiore has revealed that combining skeletal muscle relaxants or opioids~     with NSAIDs does not improve outcomes. It remains uncertain if adding benzodiazepines to~     NSAIDs improves LBP outcomes.~      Although benzodiazepines are used in 300,000 US ED visits for LBP annually, scant evidence~     exists to determine the appropriateness of this approach. Efficacy of benzodiazepines may be~     related to direct or centrally-mediated action on skeletal muscle or may instead work by~     mitigating anxiety about the condition or numbing a patient to the pain.~      Given the poor pain and functional outcomes that persist beyond an ED visit for~     musculoskeletal LBP, we propose a clinical trial to evaluate whether combining a~     benzodiazepine with an NSAID is more effective than NSAID monotherapy for the treatment of~     acute, non-traumatic, non-radicular low back pain. Specifically, we will evaluate the~     following hypothesis:~      A daily regimen of naproxen + diazepam will provide greater relief of LBP than naproxen +~     placebo one week after an ED visit, as measured by the Roland Morris Disability~     Questionnaire.~   "
70353|NCT02646111|"~     The purpose of this study is to evaluate the efficacy and safety of triple therapy of AbbVie~     adults with chronic hepatitis C virus (HCV), who have not responded to prior treatment with~     protease inhibitors.~      The Triple therapy of AbbVie attacks various sites of the viral genome, thus increasing the~     potential efficacy of the treatment, especially for patients who have failed PI treatment.~   "
70354|NCT02646098|"~     Primary objective:~      To assess the differences in the overall survival at 3 years of a CD34+ cell selection versus~     no selection of hematopoietic progenitor cells harvested during peripheral blood stem cell~     collection before high-dose chemotherapy with autologous stem cell transplantation (ASCT) in~     advanced stage mantle cell lymphoma (MCL) or diffuse large B-cell lymphoma (DLBCL) patients.~      Secondary objectives:~      To assess differences in disease-free survival between CD34+ cell selection versus no~     selection of hematopoietic progenitor cells harvested during peripheral blood stem cell~     collection before high-dose chemotherapy with autologous stem cell transplantation (ASCT) in~     advanced stage mantle cell (MCL) or in diffuse large B-cell lymphoma (DLBCL) patients.~      To compare hematologic engraftment and the time needed until hematologic recovery after ASCT~     using CD34+ selected or unselected autologous stem cell grafts.~      To compare infectious complications, particularly CMV infections, observed until 100 days~     after ASCT comparing CD34+ selected or unselected autologous stem cell grafts.~      To assess the response rate at day 100 after ASCT in advanced stage mantle cell lymphoma~     (MCL) or diffuse large B-cell lymphoma (DLBCL) patients after ASCT comparing patients with~     CD34+ cell selection versus no selection.~      To assess the total time needed for the apheresis procedure and the number of apheresis days~     needed to ensure the collection of a sufficient number of autologous stem cells comparing~     patients with CD34+ cell selection versus no selection.~      To assess the need for the additional use of G-CSF (Neupogen) and of the stem cell releasing~     compound Plerixafor (Mozobil) to ensure the collection of a sufficient number of autologous~     stem cells comparing patients with CD34+ cell selection versus no selection.~      Outcome(s):~      The aim of the study is to show ≥ 15% better 3-year overall survival of lymphoma patients~     having received CD34+ cell selection during autologous stem cell collection before autologous~     stem cell transplantation compared to no CD34+ cell selection.~   "
70355|NCT02646085|"~     Patients with Multiple Myeloma will undergo single timepoint Positron Emission Tomography~     imaging with intravenously injected C11 Methionine to detect viable lesions.~   "
70356|NCT02646072|"~     The purpose of this study is to determine whether there is a relationship between~     inflammatory cytokines in the aqueous of the eye and thickness of the macula after treatment~     of topical ketorolac for patients undergoing cataract surgery.~   "
70357|NCT02646059|"~     Blood donor recruitment is an important issue in every country, since the blood supply~     pressure become more and more intense. Donor retention is even more important, because it is~     easier to recruit an old customers than a new one. Therefore, figuring the most effective~     ways of recruiting lapsed blood donors and understanding the reasons of not donating blood~     again is critical and vital for the development of blood donation.~   "
70358|NCT02646046|"~     Investigators designed the novel combining technique that rescuer start the chest compression~     with one hand during calling for help to the Emergency Medical System (EMS) via a cell phone~     with another hand when he witnessed the arrest victim. This method may be helpful to reduce~     the hand-off time and increase the faction time of chest compression until the arrival of EMS~     members.~      To verify this hypothesis, we conducted a random, controlled simulation study.~   "
70359|NCT02646033|"~     This study analyse the rise in Intraocular Pressure while patient is in surgery in head low~     position.~   "
70360|NCT02646020|"~     Study hypothesis is that aprepitant is more effective than desloratadine in relieving~     pruritus caused by EGFR TKIs. Primary endpoint is the effective rate of pruritus, effective~     treatment defined as visual analogue scale (VAS) decrease ≥ 50% after treatment compared to~     baseline score. 130 NSCLC patients undertaken EGFR-TKI and suffer from moderate or severe~     pruritus (VAS score ≥ 4) will be enrolled in this study, and stratified (gender, first or~     seconde generation TKIs, VAS 4-6 or 7-10) randomized (1:1) into aprepitant or desloratadine~     treatment. VAS investigation will be taken once a week to treatment end or follow-up end (≤12~     weeks).~   "
70361|NCT02646007|"~     Kienböck's disease is characterized by avascular necrosis of the lunate wrist bone, which is~     usually progressive without treatment.~      Cell therapy is useful in treatment of degenerated bone and mesenchymal stromal/stem cells~     are the best candidates for this kind of treatment.~      This study examined lunate core decompression in combination with implantation of autologous~     bone marrow derived mesenchymal stromal cells for Its treatment potential.~      Bone decompression in combination with implantation of autologous bone marrow derived~     mesenchymal stromal/stem cell will be done in 30 patients with Kienböck disease.~      The patients will be followed at 2weeks, 3months, 6m and 12 months after implantation.~      The Spss(v16) software will be used for data analysis.~   "
73308|NCT02607410|"~     To compare the short and long term effects of inhibitor of the DPP-IV enzyme, sitagliptin ,~     with bedtime NPH insulin in patients with T2D inadequately controlled with sulphonylurea plus~     biguanide: effects on beta cell function and on metabolic profile.~   "
70362|NCT02645994|"~     Advancement in techniques for anaesthetic drug delivery and real time monitoring has~     facilitated safe induction and maintenance of anaesthesia in severely compromised patients.~     Cardiac diseases are the commonest causes of morbidity and left ventricular failure is the~     commonest clinical presentation at the end stage. LV systolic dysfunction is defined as~     reduction in LVEF ≤55%. Patients with LVEF 55%-46% have mild, 45%-36% moderate and ≤35%~     severe LV systolic dysfunction. Patients with heart failure have a diminished cardiac reserve~     capacity that may be further compromised by anaesthesia. In addition to depression of~     sympathetic activity, most anaesthetics interfere with cardiovascular performance, either by~     a direct myocardial depression or by modifying cardiovascular control mechanisms. Propofol~     with fentanyl is advocated as the best anaesthetic combination for induction of anaesthesia~     in patients undergoing CABG. Propofol is a drug with narrow therapeutic index and may cause~     severe hypotension and hemodynamic instability during induction of anaesthesia, especially if~     it is given in too large doses.~      Automated drug delivery systems are popular for delivery of propofol. They can be of two~     types, depending on whether they are based on pharmacokinetic or pharmacodynamic principles.~     Closed Loop Anaesthesia Delivery system has been used world-wide and in our institute in~     patients of various age groups and in patients undergoing cardiac surgery. But still the~     studies are lacking in patients with moderate to severe left ventricular systolic~     dysfunction. Moreover none of the studies have compared the efficacy of anaesthetic drug~     delivery using these two devices in this group of patients.~      Thus there is paucity of literature regarding PK and PD of propofol in patients with cardiac~     failure. The investigators hypothesized that as the Closed Loop Anaesthesia Delivery System~     is based on pharmacodyanamic principles, it should perform better than the Target Control~     Infusion system, which works on pharmacokinetic principles. The investigators planned to~     conduct this study to determine the anaesthetic depth control using Closed Loop Anaesthesia~     Delivery system vs. manual control using Target Controlled Infusion in patients with moderate~     to severe left ventricular systolic dysfunction.~   "
70363|NCT02645981|"~     Donafenib versus sorafenib for advanced hepatocellular cancer.~   "
70364|NCT02645968|"~     The purpose of this study is to collect valid data from all forms of health care on the~     incidence, prevalence, the regional distribution, characteristics, management and outcomes of~     different ILDs under clinical practice conditions.~   "
70365|NCT02645955|"~     Primary Purpose:~        1. Evaluate the prevalence and incidence of HEV infection in MHD patients.~        2. Compare differences of the prevalence and incidence between the MHD patients and the~          control. .~      Secondary purpose:~      Analyze risk factors of HEV infection.~   "
70366|NCT02645942|"~     The investigators designed this intervention to investigate the potential role of L-C in~     lipid and carbohydrates metabolism (primary outcome) with precision noninvasively measurement~     of: central blood pressure, pulse wave velocity and peripheral arterial stiffness (secondary~     outcome) in OSA patients.~   "
70367|NCT02645929|"~     Our recent randomized controlled trial of psychotherapies for posttraumatic stress disorder~     (PTSD) showed that Interpersonal Psychotherapy (IPT) benefitted patients. The mechanism of~     action for IPT is unclear; unlike most PTSD therapies, it does not work through exposure to~     trauma reminders. This assessment study will assess Symptom-Specific Reflective Function, a~     measure of emotional awareness of one's PTSD symptoms, as a potential mediator of IPT,~     capitalizing on naturalistic treatment of military veterans with PTSD at Columbia~     University/New York State Psychiatric Institute.~   "
70368|NCT02645916|"~     The Purpose of this trial is to investigate the efficacy and safety of~     Danggui-Sayuk-Ga-Osuyu-Saenggang-tang(DSGOST) on Korean Patients With Cold Hypersensitivity~     in the Hands~   "
70369|NCT02645903|"~     Living donor organ transplantation has increased in recent years due to an increased need for~     organs. The objective of this study was to investigate the effects of a TAP block on~     postoperative analgesia and opioid consumption in liver transplantation donors in whom a~     right lateral extending upper mid-line abdominal incision was used.~   "
70370|NCT02645890|"~     The purpose of this study is to compare the safety and pharmacokinetics profiles of CKD-397~     in healthy male volunteers.~   "
70371|NCT02645877|"~     This was a retrospective analysis of a cohort of all emergency care patients in Beijing from~     January 2005 to December 2014. This aim of this study was to analyze the trends in~     pre-hospital emergency care need and the emergency response times, with the intention of~     aiding the government to optimize medical resources and improve pre-hospital emergency care.~   "
70372|NCT02645864|"~     Esophageal cancer is one of the common malignant tumors. The annual incidence of esophageal~     squamous cell carcinoma is 260,000 with the mortality of 210,000 in China. Different from~     that in western countries, esophageal squamous cell carcinoma (ESCC) is still the dominant~     pathological type in China and account for more than 95% cases in clinic. The prognosis of~     ESCC is very poor. About 50% of patients have advanced disease at diagnosis with a 5-year~     survival rate of only 5-7%. Though esophagectomy is standard treatment, disease will relapse~     in many patients.~      For patients with unresectable or recurrent disease, chemotherapy is an important treatment~     alone or with radiotherapy. Taxane, platinum, and fluoropyrimidine have been reported~     effective in ESCC and is popularly used in first-line treatment of ESCC. However, there is~     still no standard 2nd-line treatment for patients who fail in first-line treatment. Both~     irinotecan and taxane had been studied as 2nd-line treatment for esophageal cancer patients.~     But there are only a few of ESCC patients involved in those studies.~      Except for chemotherapy, targeting treatment is another promising treatment for esophageal~     cancer. In recent years, antiangiogenic treatment has been proved to be effective and~     tolerable in many cancers such lung, colorectal, and gastric cancer. Apatinib is an also~     known as YN968D1, is an orally antiangiogenic agents. Preclinical and clinical data has shown~     that it is effective in the treatment of a variety of solid tumors including esophageal~     cancer. And it was approved and launched in China in 2014 as a 3rd-line treatment for~     patients with advanced gastric cancer.~      Therefore, investigators initialize this dose escalation phase I study to explore the safety~     of irinotecan and apatinib combination treatment in ESCC patients with relapse disease after~     esophagectomy and failure in 1st-line chemotherapy. Investigators will analyze the maximum~     tolerated dose (MDT) and dose-limiting toxicity (DLT) in this study.~   "
70373|NCT02645851|"~     Rapid volume expansion using repeated intravenous fluid boluses is a very common intervention~     performed in the intensive care unit (ICU) in the early days of resuscitation of patients~     with shock. Once passed the initial phase of resuscitation, the fluid boluses administered~     fail to effectively increase the patients' cardiac output in about 50% of cases. Pulse~     pressure changes or stroke volume changes induced by a Passive Leg Raising (PLR) test have~     acceptable/good ability to predict fluid responsiveness (in terms of cardiac output change)~     and may be systematically used in patients with persistent shock with the aim of limiting the~     total amount of fluid administered to patients by avoiding undue fluid boluses. One may~     suppose that such a volume expansion management policy could impact morbidity and mortality~     of shocked patients. Among the predictive indices available in clinical practice, the PLR~     test has the advantages of being usable regardless of the patients' respiratory status and~     cardiac rhythm. Changes in left ventricular stroke volume during the PLR test perform better~     that changes in pulse pressure to predict fluid responsiveness. However, in counterpart,~     pulse pressure changes during PLR can be assessed without the need of other hemodynamic~     exploration such central venous pressure measurement or cardiac output monitoring. The~     investigators hypothesized that strategies using either stroke volume changes or pulse~     pressure changes induced by the PLR test to decide wether a fluid bolus clinically deemed~     indicated should or should not be administered, may limit the amount of fluid received by the~     patients during the first 5 days of shock, improve their oxygenation index, and shorten the~     time passed under mechanical ventilation, as compared to a liberal strategy (usual care)~     that does not use predictive indices of fluid responsiveness.~   "
70374|NCT02645838|"~     The purpose of this study is to determine whether or not motivational interviewing is~     effective in smoking cessation at general practice setting in China.~   "
70528|NCT02643797|"~     This study is a cluster (clinic level) randomized pragmatic trial to compare the~     effectiveness of MA Health Coaching (MAC) delivered by non-clinician primary care staff~     (i.e., MAs) versus usual care (UC) in improving diabetes clinical control among individuals~     with poorly controlled type 2 diabetes mellitus (T2DM).~   "
70375|NCT02645825|"~     Investigators need to establish a formal diagnostic of superficial adenopathy through~     complementary investigations to find etiologic diagnostic ( Echography, adenogram).~      Echography examination should be a guide to take in charge the adenopathy and to predict~     presence of malignant (primitive) or benin (reactional) character of adenopathy. The aim of~     this study is to codify the management of adenopathic patient with a diagnostic in 48 hours~     after examination. This fast diagnostic helps to prevent unnecessary biopsy, to avoid wasting~     time in case of a serious pathology.~   "
70376|NCT02645812|"~     Fatigue, or asthenia, is an important symptom for the diagnosis and follow-up of patients in~     routine as well as research oriented clinical practice.~      Various questionnaires measuring fatigue have been developed, but few have been validated in~     french. MFI (Multidimensional Fatigue Inventory) has been validated in french in only one~     study. BFI (Brief Fatigue Inventory) has been translated but never validated in french~     language.~      The main purpose of this study is to validate psychometrically the french version of BFI.~   "
70377|NCT02645799|"~     The main objective of this study is to assess the safety, efficacy and dose response of~     LABR-312 administered intravenously at the time of percutaneous coronary intervention (PCI)~     with a drug eluting stent in reducing restenosis as measured by Optical Coherence Tomography~     (OCT) at 9 months post procedure in patients with diabetes mellitus (DM).~      Administration of LABR-312 at the time of PCI will reduce restenosis compared with placebo as~     assessed by the OCT endpoint of % neointimal hyperplasia (%NIH) volume at 9 months in~     patients with DM.~   "
70378|NCT02645786|"~     The investigators evaluated the cardiac effects of Thyroid-stimulating hormone (TSH)~     over-suppression in women with differentiated thyroid cancer (DTC) frequently encountered~     during suppression therapy.~   "
70379|NCT02645773|"~     To investigate intervention with early application of non-ablative laser to prevent scarring~     in the skin~   "
70380|NCT02645760|"~     The purpose of this study is to examines the effectiveness of Core stabilization exercise on~     pain intensity at rest, functional disability, lumbar movement and ability to perform~     repositioning tasks (joint position sense) in patients with subacute non-specific low back~     pain.~   "
70381|NCT02645747|"~     The objective of this retrospective chart review is to evaluate drug utilization, usage~     patterns and indication of effectiveness Eylea in the routine clinical (real-life) management~     of patients who suffer from ME(Macular Edema), secondary to CRVO(Central Retinal Vein~     Occlusion ), and who started treatment with Eylea for this indication.~   "
70382|NCT02645734|"~     In this double clinical trial 132 patient with the history of DME (Diabetic Macular Edema) to~     receive intravitreous bevacizumab at a dose of 1.25mg (44 patient) , ziv-aflibercept at dose~     of 1.25 mg (44 patient) , ziv-aflibercept at dose of 2.5 mg (44 patient) .~      The study drugs were administered as often as every 4 weeks for 3 months.monitoring of~     best-corrected visual acuity, CST ( Central Subfield Thickness) by OCT (Optical coherence~     tomography) was done from base line ,4 weeks, 8weeks after injection.~   "
70383|NCT02645721|"~     The purpose of this study is to determine whether extensive internet based cognitive behavior~     treatment program with guidance is a more effective method to treat individuals with alcohol~     use disorders than a briefer cognitive behavior treatment program without guidance.~   "
70384|NCT02645708|"~     The treatment of renal calculus by retrograde intrarenal surgery(RIRS) isn't able to~     eliminate stone completely, hastening fragments clearance just only rely on traditional~     expulsive methods such as high fluid intake ,increasing physical activity, medical expulsive~     therapy and changing body position. Therefore, researchers purpose to evaluate the~     effectiveness of external physical vibration lithecbole(EPVL) in treatment of residual~     fragments after RIRS by prospective study of clinical trial, which will improve stone-free~     rate of residual fragments and benefit more patients.~   "
70385|NCT02645695|"~     Effects of the high frequent chest wall oscillation technique applied on the patients who~     were intubated in intensive care unit were investigated.~      A total of 30 patients who were intubated and under the mechanical ventilator supplied, were~     included in the study. While the control group (n=15) received routine pulmonary~     rehabilitation technique, the study group (n=15) was administered high frequency chest wall~     oscillation for 72 hours as 4 times of 15-minute intervals, in addition to the pulmonary~     rehabilitation technique. Patients 'APACHE-II scores, dry sputum weight, Lung Collapse Index~     and blood gas values were measured at the hours 24th, 48th and 72nd, and endotracheal~     aspirate culture was studied at initial and 72nd. In addition, patient outcomes were~     evaluated at the end of the first week.~   "
70386|NCT02645682|"~     The purpose of this study is to investigate the effect of anti-infective central venous~     catheter(Certofix®Protect) on reducing catheter-related bloodstream infection in critically~     ill patients in China, and the relationship between catheter-related bloodstream infection~     and catheter-related thrombosis.~   "
70387|NCT02645669|"~     Saccharomyces boulardii is commonly employed as a live non-pathogenic probiotic microbial~     feed or food supplement. S. boulardii reduces the secretion of key pro inflammatory cytokines~     and promotes the production of anti-inflammatory cytokines such as IL-10, which is pertinent~     in the context of pathogenic mechanisms in periodontitis.~   "
70388|NCT02645656|"~     Curcumin (diferuloylmethane) is the chief component of the spice turmeric and is derived from~     the rhizome of the East Indian plant Curcuma longa. Curcuma longais a member of the~     Zingiberacae (ginger) family of botanicals and is a perennial plant that is native to~     Southeast Asia. Turmeric contains a class of compounds known as the curcuminoids, comprised~     of curcumin, demethoxy curcumin and bisdemethoxycurcumin.~   "
70389|NCT02645643|"~     The doctor-patient relationship was becoming worse. More and more work-related violence has~     happened to physicians and nurses. A portion of medical students felt depressed and thought~     that the career future was gloomy. The study was designed to measure the empathy, an vital~     element of professionalism, well-being of mental and study emotion. Furthermore, the~     investigators explored an intervention of group study to promote medical students'~     professionalism, mental health and study emotion.~   "
70529|NCT02643784|"~     This is an exploratory, randomized, open-label, 2-arm, parallel-group study exploring the~     efficacy of rosuvastatin (20mg/day) in patients with acute ischemic stroke.~   "
70530|NCT02643771|"~     The purpose of this study is to determine whether periodontal treatment improves the~     periodontal clinical parameters in the periodontal patients with diabetes regarding~     non-diabetics: two years follow-up.~   "
70390|NCT02645630|"~     Cervical spine manipulation has been found to be effective in patients with mechanical neck~     pain. Discrepancies exist on the side of manipulation and the placebo effect of this manual~     intervention. In addition, some authors have proposed that spinal manipulation can alter~     proprioception of the cervical spine. The aim of this study will be to investigate the~     effects of cervical spine manipulation on pain, disability, widespread pressure pain~     sensitivity, and cervicokinethesia in patients with mechanical neck pain.~   "
70391|NCT02645617|"~     The purpose of the study is to confirm the safety of Advantage Anti-Caries Varnish.~   "
70392|NCT02645604|"~     Background: Malaria is a disease caused by a parasite. People get malaria if they are bitten~     by an parasite-infected mosquito. A drug called artemether-lumefantrine (AL) can treat~     malaria. Although iAL has helped make the malaria problem less severe in the African country~     of Mali, researchers want to find out if malaria parasites are becoming resistant to this~     drug.~      Objective: To test for AL-resistant parasites in children with malaria in Mali.~      Eligibility:~      AL resistance monitoring study: children aged 2 17 years who live in Kenieroba, Mali, and~     have malaria.~      Blood collection substudy: healthy volunteers aged 18 65 years.~      Design:~      Volunteers for the substudy will have blood taken up to 6 times a year.~      Study participants will be screened with 1 finger-prick blood sample. Girls may have a~     pregnancy test.~      Baseline visit: Participants will have a physical exam. Their vital signs and temperature~     will be measured. They will answer questions about their symptoms. They will give a blood~     sample.~      Participants will get 6 doses of AL over 3 days. They will take it in tablet form with milk.~      Some participants will also stay at the clinic for 2 days. They will have a catheter placed~     in a vein. They will have blood taken frequently.~      Participants will have follow-up visits for about 1 month. They may have:~      Physical exam performed~      Vital signs and temperature measured~      Symptom questionnaire administered~      Finger-prick blood sample and/or a regular blood sample taken~      Pregnancy test given~      Antimalarial medications other than AL provided.~   "
70393|NCT02645591|"~     The goal of this clinical research study is to learn about the safety and the effectiveness~     of using AmnioFix® (dehydrated human amnion/chorion membrane, also called dHACM) to help~     improve the return of erectile function and bladder control in patients after robotic~     assisted laparoscopic radical prostatectomy (RARP).~      dHACM is a section of tissue made from part of the placenta donated by a mother during a~     C-section. It looks like a small piece of tissue paper and is wrapped around the nerve~     bundles in the surgical area. The tissue may help the body's normal healing process.~   "
70394|NCT02645578|"~     This study is a prospective multicenter randomized controlled trial from Asian countries to~     compare the effect and safety of right median nerve stimulation versus traditional treatment~     for comatose patients at the early stage following traumatic brain injury.~   "
70395|NCT02645565|"~     This study will be conducted to find out whether low dose or high dose cyclophosphamide~     therapy is effective in the treatment of proliferative lupus nephritis.It will also compare~     the side effects and risks of infection in low dose and high dose cyclophosphamide group.~     Half of the participants will receive a low dose cyclophosphamide for 3 months and half will~     receive high dose cyclophosphamide therapy monthly for 6 months followed by azathioprine 2~     mg/kg.~   "
70396|NCT02645552|"~     This study is a prospective single-centre randomized trial to compare the effect of~     tranexamic acid versus placebo in the pre-hospital management of patients with moderate and~     severe traumatic brain injury.~   "
70397|NCT02645526|"~     The aim of the present study is to assess the effectiveness and the safety of a woolen cap in~     maintaining normothermia in low birth weight infants (LBWI) during Kangaroo Mother Care~     (KMC).~   "
70398|NCT02645513|"~     The purpose of this study is to assess whether twice-daily text message reminders over a~     six-month period to health workers in Malawi about diagnosis and treatment of malaria,~     pneumonia, and diarrhea improve case management of these diseases.~   "
70399|NCT02645500|"~     In this study, the investigators would use the training workshops as a capacity build method~     to deliver the holistic health knowledge for the trainers and ambassadors implementing and~     assisting the community-based programs for the public. The investigators hypothesize that the~     training workshops and mobile health messages would promote the health awareness and the~     health of the participants. The investigators would expect the participants influence the~     health behavior and attitude of their family members.~   "
70400|NCT02645487|"~     SRS dose escalation for brain metastases in radiation-naïve patients will establish true~     tolerable doses, which may exceed the current standard doses. This may lead to an improvement~     in local control, patient survival, and/or quality-of life.~   "
70401|NCT02645474|"~     Two regional anesthesia techniques already in use in common clinical practice -paravertebral~     block and pectoral nerve block (PECS block) are compared in a randomized, double-blind,~     multicenter, controlled, non-inferiority trial, in order to compare their success rate in~     patients udergoing breast surgery.~   "
70402|NCT02645461|"~     Amyotrophic lateral sclerosis (ALS) is a fatal disease leading to motor neuron degeneration~     and progressive paralysis. Other studies have revealed defects in skeletal muscle even in~     absence of motor neuron anomalies, focusing on acetylcholine receptors (AChRs) and supporting~     the so-called dying-back hypothesis. Outcome of this study will be to understand if the~     endocannabinoid palmitoylethanolamide (PEA) can reduce the rundown of AChRs currents in ALS~     muscle, and if it can modify ALS patients' clinical and electrophysiological parameters.~   "
70415|NCT02645292|"~     The worldwide epidemic of physical inactivity is rising significantly and the main cause is~     sedentary lifestyle. In this era of globalization and rapid advancement of technology, people~     are chasing after worldly matters, leading them to abandon the most important factor in their~     life and that's their body. Most people are leading a sedentary lifestyle as they indulge~     themselves in their never-ending work. There is a significant lack of awareness on the~     importance of physical activity and cardiorespiratory fitness to health as people are~     focusing more on factors such as smoking, cholesterol and hypertension. The purpose of this~     study is to evaluate the effectiveness of stair climbing (SC) and 1 mile walking (1MW) in~     relation to cardiorespiratory responses and fitness.~   "
70416|NCT02645279|"~     The purpose of this study is to demonstrate the effectiveness of oral glucose administration~     during MRI for imaging of newborns and compare with midazolam sedation.~   "
70403|NCT02645448|"~     The aim of this study was to investigate and correlate the glucose responses and VFC 24 hours~     after resistance exercise (RE) sessions at different intensities in women with type 2~     diabetes (DM-2). Twelve women with DM-2 were invited to perform by one week in randomized~     order, two weeks interventions with experimental sessions: Session Control (CONT) without~     conducting RE, RE session (40% or 80% of one maximum repetition - 1RM) on day 2 and day 3 was~     observed the effect of the length of RE session by 11h. After that, initiated the~     experimental sessions, where after each of the analysis of glucose 24h by continuous~     monitoring system of glucose was performed, considering breakfast, lunch, dinner and sleep,~     and analysis performed of the RR series by a period of 48h. During control sessions, the~     subjects were seated comfortably for 40min and RE sessions, 40%1RM and 80%1RM, were performed~     in medium circuit 3 sets with 16 and 8 replications and recovery range between 60 exercises~     and 90seg , respectively, and between the circuits 120sec. It was observed that the~     concentration of glucose in the period of 24h after the session has been reduced to 40% 1RM~     vs. CONT and 80%1RM. Hyperglycemia was prevalent in the period 34h of the sessions CONT and~     80%1RM, respectively , being different from the session 40%1RM. In postprandial times,~     shorter hyperglycemia was found in the session to 40% 1RM vs. CONT and 80% 1RM after~     breakfast, lunch and dinner. At the time of sleep, less time in hyperglycemia was found~     between sessions of 40% 1RM vs. 80% 1RM. Significant correlations (p <0.01) were found~     between glucose 24h with cardiac autonomic RRi variables, HF, LF and reason LF:HF.~   "
70404|NCT02645435|"~     Background:~      Direct anterior approach to the hip (DAA) is being considered as one of the most promising~     minimally-invasive approaches in total hip arthroplasty (THA). Purpose of this study is to~     analyse influence of learning curve on clinical and radiographic outcome in direct anterior~     approach (DAA) for total hip replacement.~      Methods:~      The first 30 patients operated with DAA (group B) were compared to 39 patients operated by~     Hardinge approach (group A). Peri-and postoperative complications, Harris Hip Score (HHS),~     implant positioning, experienced pain and patient satisfaction were evaluated at a mean~     follow-up of 32 months.~   "
70405|NCT02645422|"~     The aim of the present study is to identify new obesity-related genetic defects and determine~     their association with clinical manifestations in families with childhood-onset severe~     obesity. The investigators hypothesize that by exploring children with severe early-onset~     obesity they can find new obesity-related genetic defects and by exploring obesity-associated~     clinical manifestations the investigators can elucidate the outcomes of severe childhood~     obesity.~   "
70406|NCT02645409|"~     Primary~      • To explore the use of OTL38 and fluorescence imaging to detect RCC in partial nephrectomy~     at the margins of resection, and in lymph node(s) or other metastases during radical~     nephrectomy.~   "
70407|NCT02645396|"~     The purpose of this study is to assess the risk of congenital cytomegalovirus (cCMV)~     infection in newborns born to seropositive women.~   "
70408|NCT02645383|"~     The aim of this study is to compare the severity of expressed pain scores in patients with~     PDR who underwent either PASCAL or conventional laser and to assess the association between~     patient characteristics and severity of pain.~   "
70409|NCT02645370|"~     The purpose is to evaluate the effectiveness and safety profile of Danzhen for the~     prophylaxis of migraine in a real-world setting.~   "
70410|NCT02645357|"~     Implementing an evidence-based computerized decision support system linked to electronic~     health records to improve care for cancer patients.~      The ONCO-CODES (Computerized DEcision Support in ONCOlogy) trial is a pragmatic, parallel~     group, randomized controlled study with 1:1 allocation ratio Study Duration 12 month Study~     Center(s) Single-center~      Objectives:~      The primary outcome of this trial is a process outcome. i.e. the rate at which the issues~     reported by the reminders are resolved (resolution rates).~   "
70411|NCT02645344|"~     The objective was to compare the effects of repetitive Transcranial Magnetic Stimulation~     (rTMS) combined with sensory cueing (SC), rTMS alone, and conventional rehabilitation on~     reducing unilateral neglect (UN) and improving hemiplegic arm functions and performance of~     activities of daily living (ADL). Sixty subacute patients with left UN after~     right-hemispheric stroke were randomly assigned to three groups; rTMS combined with SC, rTMS~     alone, and conventional rehabilitation. rTMS at 1 Hz was applied over P5 of the~     contralesional hemisphere while vibration cueing was emitted using a wristwatch device on the~     hemiplegic arm, five days per week for two weeks. The first two groups received the same~     dosage of conventional rehabilitation on top of their experimental interventions. Blinded~     assessments were administered at baseline, 2 weeks postintervention, and four-week follow-up~     upon completion of training.~   "
70412|NCT02645331|"~     The aim of this study was to determine the effects of an innovative child-friendly~     remind-to-move treatment (RTM) treatment by comparing it with constraint-induced movement~     therapy (CIMT) on upper extremity outcomes in children with hemiplegic Cerebral Palsy. In an~     evaluator-blinded randomized controlled trial, 73 children, among of whom 20 in Manual~     Ability Classification System level I, 38 level II, and 15 level III, were recruited from 3~     special schools and randomized to receive 75-hour RTM (n=25) and CIMT (n=24) programme over~     15-weekdays, and conventional treatment (n=24). The primary outcomes were Jebsen-Taylor Hand~     Function Test (JTHFT) and Bruininks-Oseretsky Test of Motor Proficiency (BOTMP-II) Subtest 3~     for assessing the motor efficiency at baseline, posttest, and 1- and 3-month follow-up.~   "
70413|NCT02645318|"~     Conduct a prospective study to compare gene detection by ctDNA with tumor tissue DNA via~     targeted DNA sequencing in surgical NSCLC patients.~   "
70414|NCT02645305|"~     Chronic obstructive pulmonary disease (COPD) is the name for a collection of lung diseases~     including chronic bronchitis, emphysema and chronic obstructive airways disease. People with~     COPD have difficulties breathing, primarily due to the narrowing of their airways, this is~     called airflow obstruction.~      Some preclinical evaluations showed that COPD is closely related to chronic inflammation;~     therefore, this study aimed to use adipose-derived stem cells (ADSCs) in the form of~     non-expanded culture - that usually names as a stromal vascular fraction (SVF) in combination~     with activated platelet rich plasma (PRP) to treat this disease. Both SVF and PRP are~     autologous sources that obtained from adipose tissue and peripheral blood, respectively. This~     mixture is intravenously transfused into the patients.~   "
70429|NCT02645110|"~     The purpose of this study is to evaluate the effectiveness of whole-natural hand-wash~     formulations in bacterial removal and to estimate the relative mildness of the formulations.~   "
70417|NCT02645266|"~     Diabetic Macular Edema is a serious ocular consequence of poorly controlled diabetes. Even~     though significant research has been done to clarify the pathogenesis of DME, a clear causal~     pathway of the complication is of yet undetermined. However, there is some consensus among~     researchers that a cascade of inflammatory markers plays an important role in the disease~     process. The study hopes to better delineate the role these inflammatory markers play by~     investigating whether basal levels predict response or lack thereof to Aflibercept.~   "
70418|NCT02645253|"~     This is a randomized, single-blind, placebo-controlled, sequential-group study to assess the~     safety and tolerability as well as how the drug (AZD7594) affects the body (pharmacodynamics~     [PD]) and how the body affects the drug (pharmacokinetics [PK]) when AZD7594 is given as~     single and multiple ascending doses once daily by inhalation to healthy male Japanese~     subjects, compared with placebo (non-active drug)~   "
70419|NCT02645240|"~     The study aims to identify several factors that can accurately predict the incident of~     intestinal infraction in patients with mesenteric vascular occlusion or ischemia.~   "
70420|NCT02645227|"~     The present study is designed to evaluate the combined efficacy of Platelet Rich Fibrin (PRF)~     and 1.2% Rosuvastatin (RSV) with open flap debridement (OFD) in treatment of intrabony~     defects in chronic periodontitis patients~   "
70421|NCT02645214|"~     This study is a prospective, blinded, randomized, controlled trial (RCT) with a crossover~     design to determine if antiseptic-impregnated surgical scrubs decrease the burden of~     healthcare providers (HCP) clothing contamination compared to standard, control surgical~     scrubs following a 12-hour ICU shift.~   "
70422|NCT02645201|"~     The combination of two Lactubacillus reuteri strains, ATC 55730 and ATCC PTA 6457 are~     marketed as GASTRUS® and has been proposed as better option in increasing Helicobacter pylori~     eradication rate compared to the single strain ATC 55730, due to additional anti-inflammatory~     properties of the second strain.~      Objectives of the study are to determine whether adding probiotic combination (GASTRUS®) to~     an anti- Helicobacter pylori regimen decreases adverse events and increases the eradication~     rate of Helicobacter pylori in the pediatric population infected with Helicobacter pylori~     bacteria.~   "
70423|NCT02645188|"~     Do specific verbal and tactile cues and instructions help people who perform bridging~     exercises to improve hip muscle strength to optimize recruitment of the gluteus maximus~     muscle?~   "
70424|NCT02645175|"~     A randomized, double-blind, placebo-controlled, parallel study to evaluate the safety profile~     and ability of TW1025 oral solution to decrease fatigue in HER2-negative metastatic breast~     cancer patients receiving chemotherapy.~   "
70425|NCT02645162|"~     Worldwide about 88 million children drop out of primary school annually. One of the~     contributory factors is a lack of school readiness among young children, their families and~     their teachers. To better prepare young children for school, investment in early childhood~     interventions is necessary. Young children require good health, adequate nutrition and~     social-emotional, cognitive and communication skills to succeed in school, which requires~     both support in the family environment and a stable transition to the classroom environment.~     Preschool programmes are designed to prepare children for formal learning. However, in many~     low- and middle-income countries there is poor access to quality preschool programmes.~     Further, the scale-up of early childhood interventions is challenged by a number of barriers~     such as poor supply (e.g. policy provisions, financing, distance, early child development~     workforce), inadequate cross-sector coordination, low demand (e.g. knowledge mobilization,~     agency, community of purpose, opportunities to participate) and weak quality of services~     (e.g. training, supervision and monitoring systems).~      In partnership with the National Commission for Human Development, we propose to implement an~     early childhood care and education programme in rural Sindh that is championed by Community~     Youth Leaders. The Community Youth Leaders will run community preschools for children aged~     3-6 years, and will also coordinate local community engagement and local stakeholder~     strategies across sectors to leverage demand-side actions to promote ownership and scale-up~     of early childhood interventions. The LEAPS Programme (Youth Leaders for Early Childhood~     Assuring Children are Prepared for School) will be evaluated by a cluster randomized~     controlled efficacy trial. The primary outcome will be children's school readiness, indexed~     by both early academic and social emotional competencies assessed following 6-9 months of~     intervention exposure. The compliance, fidelity and quality of the implementation process~     will also be assessed in order to understand how these features moderate outcomes and whether~     community-engagement strategies facilitate demand-side actions for scale-up. The expected~     outcomes for this trial will include a model for quality preprimary education that addresses~     a current supply-side gap, and will facilitate learning for demand-side actions to support~     scale-up across a broad range of early childhood interventions.~   "
70426|NCT02645149|"~     This is a patient oriented translational research project aiming to improve clinical outcomes~     for patients with BRAF and NRAS wild-type unresectable Stage III or Stage IV metastatic~     melanoma who have progressed on, or are unable to receive standard therapy (in general,~     immunotherapy). Consecutive patients seen at three major clinics and fitting the broad~     eligibility criteria will be invited to participate.~      The approach is designed to test the impact of different targeted drugs on different~     mutations in a single type of cancer. In this project, patients will have tumour tissue~     genetically profiled to determine which mutation(s) are present, and will then be assigned to~     receive a matched drug expected to target the mutation(s) in the tumour. Where multiple~     targets are identified in one patient, or where multiple potential therapies would be~     appropriate for a single tumour mutation, the treating clinician may determine the~     appropriate therapeutic approach after consultation with the study team, using the latest~     version of library of matched therapies.~   "
70427|NCT02645136|"~     The purpose of this study is to compare the efficacy between a Pilates exercise program and a~     Pelvic Floor Muscle Training (PFMT) protocol combined with anal electrical stimulation (AES)~     in muscular pressure strength of the pelvic floor as conservative treatment of urinary~     incontinence after prostatectomy.~   "
70428|NCT02645123|"~     Introduction: patients with chronic back pain as a result of degenerated disc disease,~     besides pain also present with impaired gait. The purpose of this study is to evaluate both~     the clinical data using clinical rating scales, such as Oswestry Disability Index Greek~     version (ODI), Numerical Pain Rating Scale for low back pain and leg pain (NPRS) and the~     Roland Morris Disability Questionnaire Greek Version, and kinetic and kinematic~     characteristics during gait analysis in patients with chronic low back pain as a result of~     the degenerated disc disease (Disc Degenerative Disease), before and after application of~     manual therapy techniques.~      Methodology: for the purposes of the study, 75 patients suffering from chronic low back pain~     were randomly divided into 3 groups of 25 each. Each group received five sessions with the~     first group receiving manual therapy treatment (spinal mobilisation), the second a sham~     treatment and the third, classic physiotherapy (stretching exercises, TENS and massage). To~     evaluate the effectiveness of each treatment, the visual analog pain scale, two~     questionnaires (Oswestry and Roland Morris) and also an optoelectronic system for recording~     and analysis of gait (kinetic and kinematic data) were utilized.~   "
70431|NCT02645084|"~     In this trial the investigators will evaluate the effectiveness of the implementation of a~     digital familial risk questionnaire in the detection of CRC patients with hereditary or~     familial CRC. This will be done using a stepped wedge design with 5 participating hospitals~     for a duration of 1.5 years. A comparison is made between an intervention phase (offering the~     online risk assessment questionnaire) and a control phase (hospital-based standard practice~     for the detection of CRC patients with hereditary or familial CRC, informed by the referral~     criteria that are being used in the intervention group). All patients with a diagnosis of CRC~     who have a first appointment at the CRC outpatient clinic will be included. The primary~     outcome is the percentage of all included patients who receive a recommendation for regular~     surveillance colonoscopies for himself/herself and/or relatives, provided by a clinical~     geneticist. Data from clinical geneticists is being used to answer this question.~   "
70432|NCT02645071|"~     Lack of physical activity was found to be a local and worldwide issue. Most Hong Kong people~     are having sedentary lifestyle. Researchers show that the increase of physical activity~     reduces the risk of chronic diseases, and improve cardio-pulmonary functions; whereas~     sedentary behaviors increase the risks.~      For many people, the targets of the WHO physical activity guidelines are too high to be~     achieved. Some people are not even willing to try, despite the evidence for the protective~     benefits to their long term health. In response, a recent focus has been placed upon~     reduction of sedentary behavior. Sedentary behavior is defined as 'those activities that do~     not increase energy expenditure substantially above the resting level, such as sitting, lying~     down, or viewing TV, or simply as too much sitting. The primary determinants of sedentary~     behavior are behavioral and context-based, such as TV and screen-focused behaviors in home~     and work environments, sitting at work, and sitting during transport. The public health~     leaders have called for reducing the time spent in sedentary behaviors as a possible public~     health priority. This study will focus on reduction of sedentary behavior and increasing~     physical activity in daily life. We hypothesize that the training programs would promote the~     health awareness of the participants.~   "
70433|NCT02645058|"~     To evaluate the effectiveness of RIRS (retrograde intrarenal surgery) and ESWL~     (extracorporeal shockwaves lithotripsy) in the treatment of renal stone ranging form 6 to 20~     mm size.~   "
70434|NCT02645045|"~     In this study, the investigators aim to determine the effects of age, sex, history of ocular~     surgery and contact lens use, and ocular surface and meibomian gland parameters on the lipid~     layer thickness (LLT) in normal subjects and patients with dry eye syndrome. Patients with~     dry eye syndrome and subjects with a healthy ocular surface will be enrolled. All participant~     will underwent LLT measurement with a LipiView interferometer, tear meniscus height~     measurement using optical coherence tomography, tear film break-up time (TBUT) determination,~     corneal and conjunctival staining, Schirmer's test, examination of the lid margins and~     meibomian glands, and assessment using the Ocular Surface Disease Index(OSDI) questionnaire.~   "
70435|NCT02645032|"~     This is a Phase I, Randomized, observer-blinded, age de-escalating study.~      The study objectives are:~        1. To evaluate the safety of 25 μg of Vi-DT typhoid conjugate vaccine administered at 0 and~          4 weeks.~        2. To assess the immunogenicity of 25 μg of Vi-DT typhoid conjugate vaccine administered at~          0 and 4 weeks.~        3. To compare the safety and immunogenicity of Vi-DT and Vi-Polysaccharide typhoid~          vaccines.~   "
70436|NCT02645019|"~     A prospective study designed to access changes in the intracuff pressure of a laryngeal mask~     airway (LMA) or cuffed endotracheal tube (cETT) during placement of an~     esophagogastroduodenoscopy (EGD) probe during an EGD in the pediatric population.~   "
70437|NCT02645006|"~     The purpose of this study is to determine whether a primary prevention workshop is effective~     decreasing at least 13% the annual incidence of falls in elderly compared to the habitual~     counseling.~      Before the first fall incident, the elderly aged 65 or more, living in community, are invited~     to attend a workshop on fall preventing activities and factor risk detection. This activity~     consists on four sessions (one session per week during three weeks and the fourth session one~     year later) in which the elderly are expected to detect their own fall risk factors,~     encouraged to introduce healthy habits and to increase physical activity in order to improve~     strength and balance specifically.~      This workshop has been prepared by family physicians following the latest scientific~     recommendations, it will be lead by them on the first edition, but it has not been written in~     formal language in order to be used by volunteers concerned about aging topics, independent~     from the Health Service.~   "
70438|NCT02644993|"~     The study aim of this study is to evaluate the effect of proton therapy on quality of life~     and long-term normal tissue toxicities of the pediatric cancer patients. Based on these~     results, the predictive model of long-term normal tissue toxicities, survival, and quality of~     life could be recognized. Risk-adapted treatment strategy based on the predictive model in~     pediatric cancer patients could be established.~   "
70439|NCT02644980|"~     For patients requiring the heart valve replacement surgery, heart function is injured in~     different degree.Thus, minimizing the impact of the anesthesia drug on the cardiovascular~     system has important clinical meanings. Etomidate has slight effect on the cardiovascular~     system, often used in the induction of anesthesia, however target controlled infusion~     etomidate in maintenance of anesthesia is less used. So, the trial is designed to observe the~     application value of TCI etomidate in thoracoscopic mitral valve replacement surgery.~   "
70440|NCT02644967|"~     The goal of this clinical research study is to find the recommended dose of the study drug~     IMO-2125 that can be given in combination with ipilimumab or in combination with~     pembrolizumab to patients with metastatic melanoma. Researchers also want to learn if the~     study drug combination can help to control the disease. The safety of the drug combination~     will also be studied.~   "
70441|NCT02644954|"~     Psoriasis vulgaris is a common, chronic, relapsing skin disease characterized by predominant~     involvement of skin, nails and joints. Recent advances in its patho-physiology have shifted~     the notion of psoriasis from that of a 'disease of the skin' to a 'T-cell mediated systemic~     disease'. Better understanding of its pathogenesis and co-morbidities along with the~     development of novel therapeutics like biological response modifiers has changed the way~     dermatologists approach the management of psoriasis. Based on the extent of involvement and~     effect on the quality of life, psoriasis may be mild to moderate in severity. This in turn~     forms the basis of treatment in majority of the patients. Topical therapies like coal tar,~     calcipotriol and corticosteroids are sufficient for mild and localized psoriasis. In more~     widespread or severe forms that are associated with significant decrease in quality of life~     of patient, phototherapy and systemic therapies are indicated either alone or in combination~     with each other. Although the introduction of biological therapies has revolutionized the~     treatment of psoriasis in recent years, such newer therapeutic options continue to elude the~     vast majority of patients in the developing and under developed world where the traditional~     agents like methotrexate, cyclosporine, acitretin and phototherapy still form the backbone of~     treatment.~      The association of psoriasis with metabolic syndrome is now well documented. Metabolic~     syndrome is a cluster of risk factors including central obesity, atherogenic dyslipidemia,~     hypertension and glucose intolerance and is a strong predictor of cardiovascular diseases,~     diabetes and stroke. Metformin, an oral hypoglycemic agent of biguanide class is known for~     its multitude of action on various facets of metabolic syndrome. Recently it has also been~     found to inhibit keratinocyte proliferation in cell culture model of psoriasis.~      The present study is designed as a randomized controlled double blind pilot study in which 40~     patients with chronic plaque psoriasis of moderate severity (PASI ≥ 6 or DLQI ≥ 6) and~     metabolic syndrome (By modified ATP III criteria)4 or impaired glucose tolerance (defined as~     two-hour glucose levels of 140 to 199 mg per dL on the 75-g oral glucose tolerance test) will~     be recruited and randomized into two arms, A and B of 20 each, by using random number tables.~     Patients in arm A will be treated with topical anti-psoriatic treatment (including coal tar~     and vitamin D3 analogues only) and oral metformin 1g/day 850mg twice daily and patients in~     arm B will be treated with topical anti-psoriatic treatment and oral placebo tablets. Post~     randomization patients will be followed up at regular intervals for 24 weeks. During each~     visit, patients in both arms will be assessed for the severity of psoriasis by psoriasis~     activity severity index (PASI) and body mass index (BMI). Fasting blood glucose and insulin~     level, glycosylated haemoglobin (HbA1c) and parameters of metabolic syndrome (including waist~     circumference, fasting lipid profile and blood pressure) will be assessed at baseline and~     again at week 16 and 24. The primary aim of this study is to assess the efficacy and safety~     of oral metformin as an add on therapy for the treatment of chronic plaque psoriasis of~     moderate severity. The secondary aim is to assess the effect of metformin on parameters of~     the metabolic syndrome.~   "
70442|NCT02644941|"~     The main purpose of this study is to compare the Human Acellular Vessel (HAV) with ePTFE~     grafts when used for hemodialysis access.~   "
70443|NCT02644928|"~     This study is designed as a prospective, single-center, longitudinal and analytical study on~     the effect of bariatric surgery in obese patients with chronic kidney disease (CKD).~   "
70554|NCT02643459|"~     Will clinical outcome for patients be improved if triage in Acute wards and Emergency rooms~     is supplemented with a prognostic biomarker?~   "
70444|NCT02644915|"~     Ischemia-reperfusion (I/R) injury is a prominent cause of delayed graft function(DGF) after~     kidney transplantation. Reactive oxygen species play a crucial role in I/R injury. Edaravone~     is a synthetic radical scavenger that has been used in acute stroke. Some animal experiments~     have revealed its beneficial effects against I/R injury, our goal is therefore to investigate~     the effectiveness of a recipient pretreatment with Edaravone at reducing the occurrence of~     DGF after kidney transplantation.~   "
70445|NCT02644902|"~     The Thinking Healthy Program is evidence based psychological intervention, delivered by~     non-specialists, with proven impact on maternal depression. A major challenge in the scale-up~     of this intervention, especially where health systems are weak, is providing quality training~     and supervision at scale. Women living in post-conflict areas are at a higher risk of~     depression than the general population.The key innovation proposed is the development and~     evaluation of a technology-assisted cascade training and supervision system to assist~     scale-up of the Thinking Healthy Programme in a post conflict area of Pakistan.~   "
70446|NCT02644889|"~     This study has been designed in order to detect EGFR mutation abundance of tissue and~     concentration of plasma from Advanced Non-small Cell Lung Cancer during treatment with~     Tyrosine Kinase Inhibitor (TKI) .Through this experiment the investigators aim to evaluate~     the feasibility of plasma EGFR detection and evaluate the correlation of EGFR mutations and~     prognosis.~   "
70447|NCT02644876|"~     Postoperative pulmonary complications (PPCs) are major causes of postoperative morbidity,~     mortality, and prolonged hospital stay.The incidence of PPCs may be as high as 41% to 75% in~     high-risk patients. Bronchodilator is frequently used in high-risk patients to prevent PPCs.~     Penehyclidine is a new anticholinergic agent which selectively block M1 and M3, but not M2~     receptors. A pilot study of the investigators showed that prophylactic penehyclidine~     inhalation reduced the incidence of bronchospasm and the use of aminophylline in elderly~     patients after long-duration surgery. The purpose of this study is to investigate whether~     prophylactically penehyclidine inhalation could decrease the incidence of PPCs in high-risk~     patients after major intrathoracic and upper intraabdominal surgery.~   "
70448|NCT02644863|"~     This study evaluates the safety and efficacy of D-CIK immune cells combined with chemotherapy~     after resection of esophageal cancer~   "
70449|NCT02644850|"~     To compare the calculated biventricular ejection fraction from cadmium-zinc-telluride (CZT)~     single photon emission computed tomography (SPECT) with planar equilibrium radionuclide~     angiography (ERNA), first-pass radionuclide ventriculography (FP-RNV) and echocardiogram.~   "
70450|NCT02644837|"~     This study will look at key performance indicators of 2 supraglottic airway devices in~     anaesthetised adults in a crossover manner.~   "
70451|NCT02644824|"~     Surgery with cardiopulmonary bypass (CPB) for congenital heart disease (CHD) causes low~     cardiac index (CI). With the increasing success of surgery for CHD, mortality has decreased~     and emphasis has shifted to post-operative morbidity and recovery. Children with CHD~     undergoing surgery with CPB can experience well-characterized post-operative cardiac~     dysfunction. When severe, patients can develop clinically important low cardiac output~     syndrome (LCOS) and hemodynamic instability. Management of LCOS and hemodynamic compromise is~     primarily accomplished via intravenous durgs like milrinone, dopamine or dobutamine, which~     affect the strength of the heart's muscular contractions. These are used to maintain adequate~     blood pressure (BP) and CI. However, inotropic agents are potentially detrimental to~     myocardial function and may increase risk for post-operative arrhythmia and impair~     post-operative recovery by increasing oxygen demand and myocardial oxygen consumption (VO2).~     In combination with the increased VO2 associated with CPB-induced systemic inflammatory~     response patients can develop a critical mismatch between oxygen supply and demand,~     essentially the definition of LCOS. Therefore, therapies that improve CI and hemodynamic~     stability without increased VO2 are beneficial. This study will test whether BiVp, a~     specialized yet simple pacing technique, can improve post-operative CI and recovery in~     infants with electro-mechanical dyssynchrony (EMD) after CHD surgery. This study hypothesizes~     that Continuous BiVp increases the mean change in CI from baseline to 48 hours in infants~     with EMD following CHD surgery compared to standard care alone.~   "
70452|NCT02644811|"~     The purpose of this trial is to study and compare two different anchorage techniques.~     Adolescent patients in need for orthodontic treatment are randomized into Group A and B. Both~     groups are treated with extractions of the maxillary first premolars and fixed appliance.~     Anchorage is reinforced by miniscrews in Group A and by molarblock in Group B.~      The hypotheses are:~        -  that placement of miniscrews does not cause more pain or discomfort than premolar~          extractions~        -  that molarblock provides increase of anchorage~        -  that miniscrews have a better anchorage capacity than molarblock~        -  that miniscrews are more cost-efficient than conventional anchorage techniques~   "
70453|NCT02644798|"~     Few patients who have major risk factors develop Acute Respiratory Distress Syndrome (ARDS).~     The heritable determinants might be the reason. The multicenter study is to investigate the~     association between ARDS and polymorphism in ARDS gene r.~   "
70454|NCT02644785|"~     The investigators aim to assess tryptase test efficacy for measuring the allergic response to~     protamine during cardiac bypass surgery. Additionally, the investigators aim to establish a~     differential diagnosis on the basis of potential allergens or clinical causes.~   "
70455|NCT02644772|"~     The purpose of this study is to determine whether the investigators can predict which~     patients are at risk of a re-exacerbation of COPD within 30 and 90 days using changes in lung~     capacity during the initial exacerbation.~   "
70456|NCT02644759|"~     Type 1 diabetes mellitus (T1DM) is a chronic, autoimmune condition that involves the~     progressive destruction of pancreatic β-cells, eventually resulting in the loss of insulin~     production and secretion. Hence, an effective treatment for T1DM should focus on controlling~     anti-β-cell autoimmunity, combined with regeneration of lost pancreatic β-cell populations,~     with minimal risk to the patient.~      This is a phase I and II clinical trial for treatment of patient with confirmed diagnosis of~     T1DM for at least 12 months prior to enrolment in this trial. This study aims to determine~     the combined effects of autologous stem cell transplantation and immunomodulation, on~     regeneration of lost β-cells and halting the immune attack on the pancreatic β-cells,~     respectively.~   "
84769|NCT02457455|"~     The aim of this study is to evaluate the incidence and status of urgent medical conditions.~     After defining the urgent situations, the investigators will evaluate the adequacy of the~     standard medical kits and trainings.~   "
70457|NCT02644746|"~     Degenerative Lumbar spinal stenosis (DLSS) is a major problem for public health and the~     primary reason the older seek lumbar spine surgery. Acupuncture is safe and maybe effective~     for DLSS but the evidence is poor. Therefore, an objective assessment of acupuncture efficacy~     is critical for making informed decisions about its appropriate role for patients. A total of~     80 participants meet prior inclusion criteria will be recruited. The participants will be~     allocated to acupuncture group or placebo needle (unpenetrated acupuncture) group randomly.~     Twenty-four treatments will be provided over 8 weeks. The primary change of Modified~     Roland-Morris Disability Questionnaire (RMDQ) and secondary outcomes including the change of~     Number Rating Scale (NRS); the change of Self-paced Walking test (SPWT); the change of Swiss~     Spinal Stenosis Questionnaire (SSSQ); the expectations that acupuncture might help~     participants with DLSS. All outcomes will be assessed at baseline, and/or after 4, 8, 20 and~     32 weeks. Statistical analysis will include independent sample t-test, Chi-squared test and~     non-parametric test. The investigators hope the result of this trial will clarify the value~     of acupuncture for DLSS and help clinicians make proper decisions.~   "
70458|NCT02644733|"~     Measuring intraabdominal pressure in the semi-recumbent position and supine position.~   "
70459|NCT02644720|"~     Multifocal intraocular lenses (MIOLs) provide enhanced far and near visual acuity, but they~     can bring about halos and glare, which are caused by design deficiencies of the IOLs.~     Compared to monofocal intraocular lens, pseudo accommodation in nonphysiological state may~     increase the difficulty of neural compensation reconstruction in patients with multifocal~     intraocular lens implantation. Patients enrolled into the study will be followed for 1 year~     and will have study visits preoperatively, at 1 week, 3 months, 6 months, 12 months~     postoperatively.In this trial, we aimed to specify the time of neural compensation~     reconstruction in patients and to explore the changes of visual function in senile patients~     with monofocal or multifocal intraocular lens implantation.~   "
70460|NCT02644707|"~     To investigate whether the supplementation of organic selenium at the adult dose (200 mcg~     per day in the form of L-selenomethionine) has a favorable impact on thyroid function,~     including the titer of anti-thyroid antibodies [Anti-thyroid peroxidase (anti-TPO) and~     Anti-thyroglobulin (anti-Tg) antibodies], in children and adolescents with autoimmune~     thyroiditis (AT).~   "
70461|NCT02644694|"~     The purpose of this study is to evaluate the pharmacokinetics (PK) of dexamethasone phosphate~     ophthalmic solution delivered via the EyeGate® II Drug Delivery System (EGDS) in patients~     undergoing vitrectomy for macular hole repair or epiretinal membrane peeling~   "
70462|NCT02644681|"~     The primary objective of this study is to evaluate if the motor-evoked potentials/motor~     action potential amplitude ratio and motor action potential amplitude measurement are useful~     in detecting spinal cord ischemia during thoracoabdominal aortic aneurysms surgery.~      The secondary objective is to evaluate the presence of a correlation between~     neurophysiological changes and other factors (such as surgical maneuvers, anesthetic and~     physiologic changes) in order to find which factor is the most important in determining~     spinal cord ischemia.~      This study is an observational, single-center, prospective study on patients with~     thoracoabdominal aortic aneurysms undergoing surgical repair with intraoperative motor-evoked~     potentials and somatosensory evoked potentials monitoring.~   "
70463|NCT02644668|"~     The primary objective of this study is to demonstrate a pharmacodynamic effect of CK-2127107~     on measures of skeletal muscle function or fatigability in patients with Spinal Muscular~     Atrophy Types II-IV.~   "
70464|NCT02644655|"~     Objectives:~      The purpose of this study is to evaluate the safety and prognosis of New Cluster of~     Differentiation Antigen 19-chimeric Antigen Receptor T (nCAR19-T) Cells in the treatment of~     recurrent/refractory B-cell tumor and the Optimal dosage of nCAR19-T cell therapy.~      Methods:~      This study designs a novel therapy using nCAR19-T. 20 patients will be enrolled.~     Cyclophosphamide 500 mg - 2000 mg/m2 (day 2) with or without Fludarabine 30 mg/m2 /day, 4~     days (day-6,-5,-4,-3); nCAR19-T transfusion：day 0(5×10※5/kg，1×10※6/kg，3×10※6/kg). According~     to the National Cancer Institute (NCI) standard (CTCAE), they will be observed 24 weeks long.~     Follow-up survey after the clinical study: within 1 months, once a week; then once a month~     for 1 years; and then once a year, a total of 15 years.~   "
70465|NCT02644642|"~     Lung isolation technique is useful for lung or heart surgeries for better visualization.~     Double lumen endobronchial tube and bronchial blocker are available for lung isolation.~     Adding disconnection technique before lung isolation is helpful to accelerate the lung~     deflation. However, the utility of disconnection technique has never been evaluated in~     comparison of double lumen tube and bronchial blocker. Therefore, the utility of~     disconnection technique in two different lung isolation technique, double lumen tube and~     bronchial blocker will be evaluated~   "
70466|NCT02644629|"~     The current study wishes to contribute to the applicability of the use of ketamine in a~     clinical setting by focusing on the efficacy of intra-nasal administration compared with the~     IV route.~   "
70467|NCT02644616|"~     The investigators research the early improvement of fluid retention and mid-term prognosis~     through the administration of tolvaptan for the patient with tricuspid regurgitation and~     right heart failure after left heart valves replacement.~   "
70468|NCT02644603|"~     The purpose of this study is to evaluate Enhanced Recovery After Surgery(ERAS) protocol~     versus conventional treatment on patients who underwent liver resection for hepatocellular~     carcinoma(HCC).~   "
70469|NCT02644590|"~     Nocturnal hypertension is recognized via ambulatory blood pressure monitoring in adolescents~     with type 1 diabetes mellitus.~      Melatonin, (as previously seen in earlier studies in adults), may alter these changes, which~     may be a benefit especially for patients with diabetes mellitus who are at risk for~     cardiovascular changes.~      The purpose of this study is to estimate the use of melatonin as treatment for nocturnal~     hypertension in young adults with type 1 diabetes melitus.~   "
70470|NCT02644577|"~     The purpose of this study is to test the efficacy of metformin for treatment~     antipsychotic-induced metabolic syndrome in bipolar disorder patients.~   "
70555|NCT02643446|"~     The Purpose of this study is to assess the seroconversion using inactivated poliovirus~     vaccine (IPV) and oral poliovirus vaccine (OPV) sequential schedule in pilot areas where IPV~     was phased introduced into national immunization program (NIP) in China.~   "
70471|NCT02644564|"~     The purpose of the study is to determine whether the introduction of early ultrasonography~     screening will change the diagnostic spectrum of soft tissue shoulder injuries in patients~     aged forty years or more. We also want to study whether certain physical tests will be able~     to predict or rule out full-thickness tears of the rotator cuff (shoulder tendons) in the~     acute phase. Another purpose is to explore the course of soft tissue shoulder injuries over a~     year, as well as to compare the results to studies on the prevalence of rotator cuff~     full-thickness tears.~   "
70472|NCT02644551|"~     This will be an interventional safety and efficacy study of CELENT07 when used as a topical~     treatment of onychomycosis in the toenails (tinea unguium) of adults 18 years and older. This~     is randomized, double-blind, parallel design, placebo and active controlled study in patients~     with mild to moderate toenail distal lateral subungual onychomycosis (DLSO) (n=120). Subjects~     will be randomized (1:1:1) to receive CELENXT07, placebo of CELENXT07 or PENLAC®, daily for~     52 weeks. Efficacy assessments will include complete cure, mycologic cure and clinical~     efficacy and safety and tolerability.~   "
70473|NCT02644538|"~     This study evaluates whether PegIFN alfa-2a add on can improve CHB patients HBsAg clearance~     at the end of 48 weeks treatment. The CHB patients who received nucleot(s)ides anti-virus~     treatment and reached HBV DNA<1000 copies/ml and HBsAg<3000 IU/ml, were randomly assigned~     into two groups: One group continue the nucleot(s)ides treatment for 72 weeks, the other add~     on PegIFN alfa-2a on the basis of the original treatment for 48 weeks, and follow up for 24~     weeks.~   "
70474|NCT02644525|"~     Background:~      Many people who live in west or central Africa are at risk for infection from a very small~     worm called Loa loa. This infection is acquired through the bite of a fly. Baby worms called~     microfilariae live in the blood. The infection most commonly causes skin itching, mild~     temporary limb swelling, and sometimes a adult worm can be seen in the white of the eye of an~     infected individual. Very rarely, people with this infection can develop problems with the~     kidneys and heart as a result of the worm s effect on the immune system. Because the vast~     majority of people with the infection have minimal symptoms, people in Cameroon usually do~     not get treated. But infection with Loa loa can cause serious problems in people who are~     being treated for infections with other parasites (namely, river blindness and lymphatic~     filariasis). Researchers want to find out of a drug called imatinib can treat Loa loa~     infection so that patients with this infection can safely receive other drugs to cure river~     blindness and lymphatic filariasis. Researchers believe imatinib can be a safe drug to use on~     Loa loa, because in the lab this drug kills the worms slowly, whereas other drugs which can~     cause treatment reactions usually kill the worms very quickly.~      Objective:~      To test if imatinib can treat Loa loa infection by killing the worms slowly.~      Eligibility:~      People ages 18-65 with non-severe Loa loa infection who are otherwise healthy~      Design:~      Participants will be screened with a physical exam and blood and urine tests.~      Participants will have a baseline visit. This will include a physical exam and blood and~     urine tests. It may include a stool sample. Participants will be randomly assigned to get 1~     dose of either imatinib or a placebo~      Participants will return to the clinic every day for 1 week, then once a week for 3 weeks.~     Visits will include a physical exam and blood tests. They will have urine tests in the first~     week.~      Participants will have follow-up visits 3, 6, and 12 months after taking the imatinib or~     placebo. These include a physical exam and blood tests. They may include urine and stool~     samples.~      If participants develop side effects, they will be treated for them.~   "
70475|NCT02644499|"~     This study will be conducted to find out how well a patient of rheumatoid arthritis (RA) will~     respond to disease-modifying antirheumatic drugs (DMARDs). RA is a chronic inflammatory~     arthritis, which leads to joint damage & disability if not treated properly. A DMARD is used~     to treat RA that slows down or prevents joint damage, as opposed to just relieve pain or~     inflammation by painkillers. The study will be conducted at the Department of Clinical~     Immunology, JIPMER (Jawaharlal Institute of Postgraduate Medical Education & Research).~     Patients will receive either a single DMARD (Methotrexate) or combination DMARDs therapy~     (Methotrexate + Leflunomide + Hydroxychloroquine). During treatment course, routine blood~     investigations will be carried out to monitor treatment response and side effects.~   "
70476|NCT02644486|"~     To observe the decreased levels of low-density lipoprotein from baseline in patients with~     obesity-related glomerulopathy (ORG) after 12 weeks of Sevelamer Carbonate treatment.~   "
70477|NCT02644473|"~     To evaluate whether there is a difference in symptomatic thromboembolism events in the subset~     of patients with a history of, or risk factors for thromboembolic disease for topically~     applied tranexamic acid in total joint arthroplasty.~   "
70478|NCT02644460|"~     This is a Phase I clinical trial evaluating abemaciclib (LY2835219), an inhibitor of cyclin~     dependent-kinases 4 and 6 (Cdk 4/6) in children and young adults with newly diagnosed diffuse~     intrinsic pontine glioma (DIPG) (Stratum A) and in relapsed/refractory/progressive malignant~     brain (Grade III/IV, including DIPG; MBT) and solid tumor (ST) patients (Stratum B).~   "
70479|NCT02644447|"~     Cellular therapies are rapidly progressing fields and have shown immense promise in the~     treatment of damaged ovarian function. The purpose of this study is to determine safety and~     efficacy of intra-ovarian injection of allogeneic HUC-MSCs with injectable collagen scaffold~     in women with Premature Ovarian Failure (POF) and to study the preliminary efficacy of~     HUC-MSCs with injectable collagen scaffold injection on ovarian function improvement.~   "
70480|NCT02644434|"~     The purpose of the present study is to investigate if intentional strategy (a more aggressive~     side branch protection strategy: elective two-stent or jailed balloon technique) is~     associated with significant reduction of side branch occlusion rate compared to conventional~     strategy (provisional two-stent strategy or jailed wire technique) in patients at high risk~     of side branch occlusion (V-RESOLVE score≥12).~   "
70481|NCT02644421|"~     Double-blind, crossover, randomized, 3x3 Latin square, placebo-controlled study of single~     intravenous dose administration of VVZ-149. To demonstrate assay sensitivity, lidocaine will~     be administered as a positive control. The study will take place during a single inpatient~     visit involving three separate treatment periods, each with a washout of (>16-hours. Study~     drugs (VVZ-149 vs. lidocaine vs. normal saline, NS) will be administered intravenously.~   "
70482|NCT02644408|"~     Megestrol is a semisynthetic progesterone derivatives, have promote anabolic effects. Can~     improve appetite, weight gain, and improve bone marrow suppression, increase the tolerance~     put, chemotherapy, improve the quality of life, is widely used in tumor radiation and~     chemotherapy of terminally ill patients. But because of its vascular embolization, vaginal~     bleeding, arrhythmia and other serious complications, there is no unified standard.~      The purpose of this study was to evaluate megestrol in esophageal squamous carcinoma radical~     chemoradiation curative effect and side effects, for rational use in the process of radiation~     and chemotherapy megestrol provide guidelines. A total of 210 patients will be accrued from~     China within 2 years.The primary endpoint is overall survival and the secondary endpoints~     include gastrointestinal reaction body weight change, performance status, leucopenia and deep~     venous thrombosis.~   "
96339|NCT02306148|"~     The main objective of this trial is to investigate the effects of a training protocol for the~     foot and ankle complex on the prevalence of running related injuries on long distance~     runners.~   "
70483|NCT02644395|"~     Background: Calcineurin inhibitors (CNIs) are the most commonly used immunosuppressive drugs~     to prevent rejection after kidney transplantation. However, the efficacy of preventing~     rejection comes at the cost of important side-effects. Among the most common side-effects is~     hypertension. Hypertension after kidney transplantation is clinically relevant, because it~     increases the risk of cardiovascular disease and is associated with increased graft loss and~     recipient mortality. The mechanism of CNI-induced hypertension is incompletely understood~     and, therefore, the treatment is currently empiric. These and other investigators recently~     showed that CNIs cause salt-sensitive hypertension by activating a sodium transporter in the~     kidney, namely the thiazide-sensitive sodium chloride cotransporter.~      Hypothesis: The investigators hypothesize that thiazide diuretics are non-inferior to calcium~     channel blockers (CCBs) (currently usually the treatment of choice) for the treatment of~     CNI-induced hypertension.~      Objective: To compare the blood pressure response to thiazide diuretics and CCBs in patients~     with CNI-induced hypertension.~      Study design: Single-center, randomized cross-over trial.~      Study population: Kidney transplant recipients with a good functioning allograft (eGFR > 30~     ml/min) who are hypertensive (daytime systolic blood pressure > 140 mm Hg) and who do not~     have proteinuria (< 1 g/day).~      Intervention: Patients will be randomized to receive chlorthalidone (12.5 mg once daily, if~     needed titrated to 25 mg once daily) or amlodipine (5 mg once daily, if needed titrated to 10~     mg once daily).~      Main study parameters/endpoints: 24-hour blood pressure recording.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: Both drugs have long been registered for the treatment of hypertension. The~     side-effect profile of both drugs is considered to be equal. The burden of the study for the~     patients are blood pressure measurements using 30-minute automated blood pressure measurement~     and 24-hour ambulatory blood pressure measurement.~   "
70484|NCT02644382|"~     The overall goal of this study is to qualitatively assess the surgical decision-making~     process from both the patient and physician perspective~        1. Conduct short in-person interviews with young women prior to surgery~        2. Conduct focus groups with breast cancer survivors about their surgical decision and~          experience~        3. Interview surgical oncologists, plastic surgeons, medical and radiation oncologists~          about their experiences and how they communicate with breast cancer patients about local~          therapy decisions~   "
70485|NCT02644369|"~     This is a phase 2 study whose main purpose is to evaluate gene changes and immune biomarkers~     in patients with solid tumors during treatment with pembrolizumab and in relation to response~     to treatment.~      Pembrolizumab is a monoclonal antibody that is designed to block a protein called programmed~     cell death 1 ligand 1 (PD-L1) which will allow the body's immune system to kill the cancer~     cells.~   "
70486|NCT02644356|"~     Palliative care represents one of the most rapidly expanding sectors of health care. Its~     rapid growth has been accompanied by widespread needs for training of multidisciplinary~     personnel to work with the unique set of health issues specific to its population of patients~     - not only those at end-of-life, but also patients with long-term, incurable, chronic and~     degenerative illnesses. This project will develop the first online continuing education~     program for palliative care personnel in the evidence-based application of complementary~     therapies, to enhance patient care and quality of life in the palliative care setting.~   "
70487|NCT02644330|"~     The purpose of this study is to evaluate the efficacy and safety of minimally invasive~     transthoracic device closure of ventricular septal defect. This is a multi-center randomized~     controlled trial. Because of the characteristics of this surgical clinical trials, surgeons,~     ultrasonic department doctors, anesthesiologists, operating room nurses and intensive care~     unit nurses are all need to be informed. Therefore the results of this trial need to be~     system evaluated through objective methods to reduce bias.~   "
70488|NCT02644317|"~     Flatfoot, one of the most common foot problems experienced by preschool-aged children,~     characterized by the collapse of the foot's medial longitudinal arch. Children with motor~     developmental delay often have flatfoot, according to clinical observation, and research~     indicates that preschool age is the main stage of the medial longitudinal arch development~     period. There flatfoot symptoms due to poor arch shock effect, poor walking endurance, likely~     to cause gait problems while growing up. The lack of a stable foot structure to support and~     maintain posture may lead to delayed motor development. Early training intervention and help~     to balance stability is the main rehabilitation goal for motor developmental delayed~     children. With understanding of the foot development of motor development delayed children,~     proper intervention can be provided to improve the movement and stability of the lower limbs.~     The possible deformation of the foot structure and resultant pain in the future can also be~     prevented.~   "
70489|NCT02644304|"~     Polycystic ovary syndrome (PCOS) is the most common endocrine disorder of reproductive aged~     women and affects approximately 5-12 % of the female population.~      In 2003 in Rotterdam , Rotterdam diagnostic criteria were redefined PCOS as affected~     individuals must have two out of the following three criteria:~        1. Oligo- and/or anovulation, (ovulation occurs less than once every 35 days).~        2. Hyperandrogenism, clinical signs include hirsutism, acne, alopecia, and frank~          virilization, while chemical indicators include raised concentrations of total~          testosterone and androstenedione , and elevated free androgen index.~        3. Polycystic ovaries on sonographic examination, presence of 12 or more follicles in~          either ovary measuring 2-9 mm in diameter, increased ovarian volume more than 10 cm3~          and/or increase in stromal echogenicity. Clearly, according to the Rotterdam diagnostic~          criteria, the majority of women with PCOS can be diagnosed without the need of~          laboratory examinations.~      Clomiphene citrate (CC) is still the first-line medication for the induction of ovulation. It~     is an anti-estrogenic compound made up of two isomers, enclomiphene and zuclomiphene; the~     latter being the more potent of the two. It is a non-steroidal compound closely resembling~     estrogen. CC acts by blocking estrogen receptors, particularly in the hypothalamus, thereby~     signaling a lack of circulating estrogens and inducing a change in the pulsatile release of~     gonadotrophin-releasing hormone (GnRH). This induces release of follicle stimulating hormone~     from the anterior pituitary and is often enough to set the cycle of events leading to~     ovulation into motion.~      Cabergoline, ergot-derived dopamine agonists with a very long half life, is an effective~     prolactin suppressor. Cabergoline oral administration contains a weekly dose of 0.5 - 3 mg,~     which could be increased, if needed, to twice a week. This medicine has slight dopamine~     agonistic side effects, headache being the most common one. Treatment in the very beginning~     should start with a partial dose (half a pill) at bedtime with a small amount of food. Low~     incidence of side effects and its weekly dose has made Cabergoline a choice drug for~     treatment of related diseases.~   "
70490|NCT02644291|"~     This is a safety (Phase 1) trial using mebendazole for recurrent pediatric brain cancers that~     include medulloblastoma and high grade glioma, that are no longing responding to standard~     therapies. The drug mebendazole is an oral drug in a chewable 500 mg orange flavored tablet.~     It is already approved to treat parasitic infections. The purpose of this study is to~     determine the safety and side effects for increasing doses of mebendazole, followed by the~     treatment of an additional 12 patients at the best tolerated dose.~   "
70491|NCT02644278|"~     The purpose of this study is to evaluate the safety and tolerability of VX-984 (M9831)~     administered alone and in combination with pegylated liposomal doxorubicin (PLD), and to~     determine the maximum tolerated dose (MTD) and preliminary evidence of efficacy of VX-984 in~     combination with PLD in subjects with advanced solid tumors~   "
73406|NCT02606084|"~     The purpose of this study is to evaluate the pharmacokinetics of a single dose of~     intranasally administered esketamine in participants with impaired renal function when~     compared to participants with normal renal function.~   "
70492|NCT02644265|"~     Detecting preserved consciousness in brain-injured patients by traditional clinical means~     requires presence of motor function. Otherwise, patients may be erroneously classified as~     being in a vegetative state. In order to circumvent the need for motor function, paradigms~     using functional magnetic resonance imaging (fMRI) and electroencephalography (EEG) have been~     developed. According to a recent meta-analysis, 15% of patients with a clinical diagnosis of~     vegetative state can follow commands by performing mental imaginary tasks, strongly~     suggesting they are indeed conscious. This is of utmost importance for prognosis, treatment,~     and resource allocation. However, consciousness paradigms are usually employed in~     rehabilitation medicine. Therefore, opportunities to optimize patient outcome at an early~     stage may be lost. As a novel approach, the CONsciousness in NEurocritical Care cohorT study~     using fMRI and EEG (CONNECT-ME) will import the full range of consciousness paradigms into~     neurocritical care. The investigators aim to assess patients with acute brain injury for~     preserved consciousness by serial multimodal evaluations using active, passive and resting~     state fMRI- and EEG-based paradigms. A prospective longitudinal database and a biobank for~     genomic and metabolomic research will be established. This approach will add essential~     clinical information, including detection of preserved consciousness in patients previously~     thought of as unconscious. Due to its complexity, this project is divided into nine work~     packages. Eventually, the investigators will have established a clinical service for the~     systematic assessment of covert consciousness, as well as an interdisciplinary research group~     dedicated to the neuronal mechanisms by which consciousness recovers after acute brain~     injury.~   "
70493|NCT02644252|"~     There is a need for improving the effect of first-line chemotherapy for lung cancer patients,~     preferably by using an approach with none or very few side effects.~      In this trial the investigators incorporate δ-tocotrienol/placebo as a nutritional supplement~     on top of standard chemotherapy for patients with advanced non-small cell lung cancer.~   "
70494|NCT02644239|"~     The ketogenic diet is a non-pharmacological treatment prescribed especially for children and~     indicated in most specialized centers for patients with refractory epilepsy. The composition~     of the ketogenic diet is based on high-fat, low-carbohydrate, moderate protein content, and~     the production of ketone bodies is the probable mechanism involved in the control of~     seizures. The relationship between the treatment of the ketogenic diet and changes in~     oxidative characteristics, physical and lipid are not well established. Some studies show a~     significant increase in total cholesterol and triglycerides in children being treated with~     ketogenic diet, but other studies have shown that changes in lipid profile in the long term~     do not appear to be significant, beyond the influence of these changes on coronary heart~     disease are unknown. The studies performed in the last two decades have shown that besides~     the changes in the lipid profile, oxidative modification of lipoproteins are essential for~     the initiation and progression of atherosclerosis and physical properties of lipoproteins~     also appear to be involved in this process, suggesting that the particle size of~     lipoproteins, through the analysis of subfractions can provide more details of the~     cardiovascular risk. Thus, this projetct aims to compare the effects of the classical~     ketogenic diet with the ketogenic diet modified with lower content of saturated fatty acids~     and a higher content of monounsaturated and polyunsaturated, the oxidative changes of LDL,~     lipidomic profile, the concentration of antioxidants in production inflammatory cytokines and~     the subfractions of LDL and HDL in children and adolescents with refractory epilepsy, the~     clinical effect on controlling epilepsy.~   "
70495|NCT02644226|"~     Desflurane is known to be the most pungent of the currently used volatile anesthetics. The~     investigators tried to find out if desflurane increases the incidence of perioperative upper~     airway complications in infants and children undergoing general anesthesia using supraglottic~     airways compared to sevoflurane.~   "
70496|NCT02644213|"~     The aim of the research is to evaluate the influence of physical and cognitive load as~     pre-mission activity on the soldier`s physical and cognitive performance, in compare to~     physical load alone.~      In order to do so, 12 healthy subjects will perform stimulated road march using a virtual~     reality environment combined with cognitive load and without, and their physical and~     cognitive performance will be evaluated by tests before and after.~   "
70497|NCT02644200|"~     Oral rehydration therapy is the only treatment recommended by the World Health Organization~     in acute diarrhea in children. The aim of this study was to compare the efficacy and safety~     of a therapy with gelatin tannate plus oral rehydration versus oral rehydration alone in~     children with acute gastroenteritis.~      This is a single-blind, prospective, randomized and parallel study performed in two Pediatric~     Services of tertiary referral hospitals. Patients, ages 3 to 36 months with acute~     gastroenteritis randomized to receive an oral rehydration solution (OR), or an oral~     rehydration solution plus gelatin tannate (OR+G). The primary outcomes evaluated were: the~     number of bowel movements after 48 and 72 hours after initiating treatments. Secondary~     outcomes were: duration of diarrhea (days), stool characteristics and adverse events. Other~     clinical variables, as weight, fever, vomiting, appetite and the acceptability of the two~     treatments were also recorded.~   "
70498|NCT02644187|"~     This pilot study will try to minimize the pain during exposure to a new red light source~     (RhodoLED®, Biofrontera Bioscience GmbH, Leverkusen, Germany) used for PDT without~     compromising its effect on AKs.~      The study design will have an open and prospective, two-armed, split-face design.~     Participants with AK lesions distributed symmetrically on the scalp, forehead, cheeks, torso,~     back, arms and/or dorsal parts of the hands are eligible for inclusion. The purpose is to~     investigate if a modified irradiation protocol can lower the pain while having the same~     effect on AK clearance rates as compared to the standard PDT irradiation protocol.~      Before any study-related procedures are performed, the participants will be thoroughly~     informed about the study and will be given the opportunity to ask questions. The participants~     will thereafter sign and date the informed consent form. This constitutes as visit 0.~      On visit 1, a randomization to either the standard or the modified irradiation protocol will~     be performed on one side of the face/body and the other irradiation protocol will then be~     applied on the other side of the face/body. The participants should have AKs on two~     comparable sites, i.e. two cheeks, arms or dorsal parts of the hands. One side will be~     randomized to receive PDT with BF200-ALA and irradiation with the RhodoLED® lamp and the~     other side will receive BF200-ALA and the Aktilite CL-128 lamp (PhotoCure ASA, Oslo, Norway),~     which is the traditional lamp used at our department as mentioned above.~      The treatment will be given at visit 1. During the treatment, the participants will be asked~     continuously, every third minute, to estimate the pain on each treatment side using the~     visual analogue scale, VAS, (where 0 is no pain and 10 is the worst pain imaginable). At the~     end of the treatment, the participants will also be asked to summarize the treatment as a~     whole on the VAS-scale. After visit 1, the participants will fill in a follow-up diary form~     with questions regarding adverse effects (AEs) during the hours and days after the treatment.~     The efficacy of the treatment will also be assessed at a follow-up (FU) visit, visit 2. The~     investigators are aiming for a non-inferior analysis, i.e. the new modified irradiation~     protocol should be at least as good as the standard irradiation protocol. The randomization~     is blinded for the investigator at the FU visit to minimize the possibility of favoring one~     irradiation protocol.~   "
70500|NCT02644161|"~     An 8-week, assessor-blind, randomized controlled trial will be conducted. A total of 138~     patients with post-stroke depression (PSD) will be randomly assigned to the combination~     acupuncture treatment (CAI) (n = 69) or least acupuncture stimulation (LAS) (n = 69) for 3~     sessions per week for 8 weeks. Treatment outcomes will be measured using the 17-item Hamilton~     Self-Rating Depression Scale (HAMD-17), the Montgomery-Asberg Depression Rating Scale~     (MADRS), and Self-Rating Depression Scale (SDS) for depression symptoms; Barthel Index (BI)~     for physical function, the Montreal Cognitive Assessment (MoCA) for cognitive performance.~     The assessment will be performed at baseline and once monthly thereafter. The study will be~     conducted in School of Chinese Medicine Clinics, Tung Wah Hospital, Kowloon Hospital.~   "
70501|NCT02644148|"~     The current commonly used for distal gastri cancer in gastrointestinal anastomosis is~     Roux-en-Y. However, the complications after Roux-en-Y reach an incidence of over 30% which~     involve nausea, vomiting, and abdominal distension. The underlying mechanism might be the~     result of interruption of intestine peristalsis. In 2013, Kim reported total laparoscopic~     uncut Roux-en-Y anastomosis could reduce Roux stasis syndrome incidence by keeping the~     continuity of jejunum. In September 2014, we carried out this operation in 30 cases in our~     centre. Our previous results showed that this operation had a low postoperative complication~     and short hospitalization time, indicating uncut Roux-en-Y anastomosis might be a safe~     procedure. However, some limitations are noticed. The report from South Korea is a~     retrospective study and the evaluation of QOL is certain subjective. Here, we aimed to~     perform the first randomized controlled clinical study on uncut Roux-en-Y anastomosis to~     improve QOL of patients after laparoscopic distal gastrectomy.~   "
70502|NCT02644135|"~     This is a pilot study of the safety, tolerability, and effectiveness of Halo to prevent acute~     upper respiratory illness and respiratory virus infections. This study will be conducted at~     one site (University Hospitals Case Medical Center) in healthy adults during the upcoming~     respiratory virus season (12/15/11 to 3/14/12). The intervention will be with Halo, a~     commercial product which is FDA-approved for the treatment of xerostomia. The placebo will~     consist of the phosphate buffered saline plus the preservatives in the Halo formulation and~     without CPC - the active antiseptic. This placebo was chosen as the Halo formulation without~     CPC serves to act as a barrier to attachment of oral pathogens, and as such is an important~     contributing factor to its antimicrobial activity (see above). Also, the formulation without~     CPC with preservatives exhibits some antibacterial and antiviral activity. Moreover, the~     formulation without CPC and no preservatives is easily contaminated and not practical to~     utilize as the placebo in these studies.~      Male and female participants 18-45 years of age will be recruited and monitored for the~     development of, duration, and severity of clinical symptoms and signs consistent with acute~     respiratory disease (defined below) captured daily through diaries, and PCR confirmation of~     important respiratory viruses including influenza, rhinoviruses, adenoviruses, and~     respiratory syncytial virus during episodes of acute respiratory disease during the length of~     the study will be undertaken. Secondary objectives will assess the tolerance, acceptability~     and adherence to Halo as well as the change in the bacterial (oral streptococci and Group A~     streptococcus) and fungal microflora in the oropharynx. School or work absenteeism, visits to~     physicians' offices, emergency departments and urgent care centers will also be captured.~     Conventional cultures for these bacterial and fungal organisms will be pursued (see below).~     Throughout the study period, the safety, tolerability, acceptability and adherence to study~     products will be assessed.~   "
70503|NCT02644122|"~     The purpose of this study is to test the good and bad effects of an experimental drug called~     SF1126. This drug is being tested in patients whose cancer has not been controlled by~     available standard therapies and who have certain genes in their tumor.~      SF1126 is a drug that inhibits a cell protein called phosphatidyl inositol 3 kinase (PI3K).~     PI3K is part of signaling pathway that tells cancer cells to grow, survive, invade and~     metastasize. PI3K also has an important role in the development of blood vessels that are~     required to support tumor growth. SF1126 is being developed by SignalRx Pharmaceuticals, Inc.~     It is considered an experimental drug because it is not approved by the FDA for any disease~     treatment.~   "
70504|NCT02644109|"~     Hypercholesterolemia is an important risk factor for cardiovascular disease, asociated~     primarily with high plasma levels of LDL lipoprotein, which in turn depend on the endogenous~     hepatic synthesis of cholesterol and its absorption at intestinal level. It has been~     demonstrated that there reducing plasma LDL is beneficial, mainly with the use of statins,~     which are the first treatment option for a moderate hypercholesterolemia.~      Phytosterols reduce the intestinal absorption of cholesterol by reducing its incorporation~     into lipid micelles. Consequently, phytosterols have become a relevant alternative treatment~     against low hypercholesterolemia. The target population are 40 to 65 years old individuals~     with low hypercholesterolemia.~   "
70505|NCT02644096|"~     Objective: The investigators hypothesized that all areas of health status after total hip~     replacement could be improved in patients aged over 65 years and over by using telephone~     support and counselling 2 and 10 weeks after surgery compared with a control group receiving~     conventional care and treatment.~      Design: A randomised clinical trial focusing on patients' health status by using SF-36 at 4~     weeks pre- and 3 and 9 months postoperatively was carried out. Sample: 180 patients aged 65~     and over were randomised 4 weeks preoperatively to either control or intervention groups.~     Measurements: Both groups received conventional surgical treatment, but the intervention~     group was interviewed by telephone 2 and 10 weeks after surgery. Patients were given~     counselling within eight main dimensions with reference to their postoperative situation.~      Key-words: THR - elderly patients - health status - postoperative support - counselling~   "
70506|NCT02644083|"~     The primary objective of this study is to test the hypothesis that DMF can improve~     mitochondrial function in the brain of people with MS. The investigators will assess~     mitochondrial function in the cerebral grey matter by measuring PCr and ATP by 31P magnetic~     resonance spectroscopy (MRS) and NAA in NAWM by 1H MRS.~   "
70514|NCT02643979|"~     Propofol is one of the most popular anesthetic drugs used for sedation during upper~     gastrointestinal endoscopies due to its quick onset and quick resolution of symptoms allowing~     patients to leave the hospital sooner. However, when administered it can also slow the~     breathing of patients and cause others to have upper airway obstruction (such as snoring)~     which can impede proper spontaneous breathing. Ketamine is an agent that is capable of~     providing both pain control and sedation while having either minimal effect on breathing or~     promoting spontaneous breathing. Combining Ketamine with Propofol has the potential to reduce~     the total amount of Propofol used resulting in a procedure being performed under the same~     level of sedation but without the downside of reduced spontaneous breathing. Patients who are~     obese (defined as body mass index greater than 35) tend to be even more susceptible to this~     effect of Propofol. The researchers are investigating whether the addition of Ketamine will~     indeed allow for this continued comfortable level of sedation while promoting continued~     spontaneous breathing in obese patients undergoing upper gastrointestinal endoscopies.~   "
70507|NCT02644070|"~     The primary aim of the present multicenter randomized controlled trial was to evaluate and~     compare the shortterm clinical and histological changes of extraction sockets after ridge~     preservation procedures with changes of extraction sockets that healed naturally.~      The secondary aim was to evaluate which, if any extraction socket characteristics could have~     affected tissue changes occurring at the augmented as well as naturally healed sites.~      Recruitment and enrollment of patients were performed from June 2011 to June 2012 in five~     university centers/private practice:~        -  University of Pisa;~        -  University of Murcia;~        -  University of Ancona;~        -  Private practice, Dr. Di Felice;~        -  University of Verona.~      Randomization:~        1. extraction sockets with spontaneous healing;~        2. extraction sockets grafted with pre-hydrated collagenated cortico-cancellous porcine~          bone, with a particle size between 600 and 1000 μm;~        3. extraction sockets grafted with cortical porcine bone, with a particle size between 600~          and 1000 μm.~      Outcome Variables~        -  Complications~        -  Changes of ridge volume contour;~        -  Vertical bone changes;~        -  Buccal-Lingual Width;~        -  Histomorphometric parameters.~      Sample size was calculated comparing outcome data between grafted sockets versus non-grafted~     sockets. The primary parameter was the change in mid-buccal vertical height (0.7±1.4mm and~     3.6±1.5mm, respectively, for the test and control groups) (Barone et al. 2008). Final sample~     size was increased to 30 subjects per group due to possible patient dropout events. Each~     center contributed according to the predetermined 1:1:1 ratio; the fresh extraction socket~     was considered the unit of randomization.~      Corrections for balancing the three experimental groups for confounding factors were not~     applied.~      A matrix elaborator performed all the analyses§§: multi-way analysis of variance (ANOVAn) was~     applied, then appropriate post hoc comparison tests were run; post hoc estimated effect sizes~     were calculated with a power of 0.9. The level of statistical significance was set at 0.05~     for all analyses.~   "
70508|NCT02644057|"~     Heart failure is recognized as one of the most common indications for hospitalization amongst~     adults aged >65 years in United States with estimated Medicare cost to be 17 billion or more.~     Chronic heart failure is one of the most life threatening cardiovascular disorder thought to~     affect nearly six million US population with 600,000 new cases every year. The heart is~     responsible for perfusion to all vital organs including kidneys and dysfunction in either~     affects both the vital organs. When dysfunction of heart leads to dysfunction of kidneys or~     vice versa it is referred to as cardio renal syndrome (CRS). The underlying pathophysiology~     for CRS has been poorly understood and considered multifactorial. Worsening renal function~     defined as increase in serum creatinine of >0.3mg/dl from baseline occurs in 20-30% of~     patients with ADHF and is associated with greater length of hospital stay, hospital~     readmission and death. A number of interventions have been used including giving diuretics~     which helps in decongestion and helps the heart pump blood more effectively. Sometimes these~     therapies are not effective and may even lead to worsening of renal function. In such cases ,~     inotrope agents which increase the contractility of the heart have been used to help pump~     more blood to vital organs. There have been very few trials assessing the efficacy of these~     agents for improving kidney function .The investigators aim to assess the renal recovery with~     two such agents - dobutamine and milrinone in patients with cardiorenal syndrome who are~     coming with acute decompensated heart failure~   "
70509|NCT02644044|"~     Multiple sclerosis (MS) is characterized pathologically by demyelination, axonal loss, and~     glial scar formation. Clinically, most patients have a relapsing-remitting course of MS~     (RRMS) that over time may become progressive without remissions - a secondary progressive MS~     (SPMS). About 15% of patients have a progressive course from onset which is called primary~     progressive (PP).~      Currently, there is no approved treatment for PPMS and for SPMS only therapy with~     mitoxantrone showed mild effect. Thus, more effective therapies need to be developed for~     treatment of SPMS and PPMS.~      Methotrexate (MTX), an anti-metabolite, has been in clinical use since 1948 when it was found~     to produce temporary remission of acute childhood leukemia.~      There are accumulating evidences that in progressive MS patients there are follicular~     lymphoid structures in the meninges and in the Virchow-Robin spaces. Therefore, intrathecal~     therapy may target the pathological follicular lymphoid activity.~      The safety of intrathecal MTX (ITMTX) has been demonstrated by its widespread use in treating~     lymphoproliferative diseases and leptomeningeal metastases. Sadik et. Al. reported about the~     feasibility and safety of using intrathecal methotrexate (ITMTX) as a treatment for~     unresponsive patients with progressive forms of MS. In their open label study they found that~     ITMTX may have a beneficial effect in progressive forms of MS and that it was well tolerated~     with no serious adverse events.~      The investigators aim is to evaluate the efficacy , safety and tolerability of intrathecal~     methotrexate administration every 3 months in progressive 30 patients with progressive MS.~     The investigators will evaluate clinical, laboratory evaluation of the blood and~     cerebrospinal fluid as well as the MRI scans of the participants. Each patient will be~     treated 4 times for 1 year with the option to continue for another 1 more year with the same~     protocol.~   "
70510|NCT02644031|"~     Post-endodontic pain (PP) still is major problem for endodontic patients, analgesics are~     routinely prescribed. Incidence of PP is reported extensively, and reviewed. PP is a~     complicated multi factorial process and is affected by factors related to patients, to the~     tooth and to the skills and experience of the dentist and because of that, if the~     interrelation of these factors is not considered in a PP, study data might be confusing. Any~     study trying to evaluate the effect of a specific technique or new device in the incidence or~     characteristics of PP should control all the confounding factors that have been described to~     be involved in the tested outcome.~      reports mention a variable prevalence of PP, ranging from 82.9 to 10.6%. These variations are~     because of the differences in study methods, and treatment procedures after root canal~     treatment, selection of patients or experience and skills of the dentists, vary when~     different studies are compared.~      Many studies had confirmed that chemomechanical debridement of the root canal results in~     extrusion of dentinal chips, pulp tissue fragments, necrotic tissues, microorganisms, and~     root canal irrigants through the apical foramen. All preparation techniques and instruments,~     regardless of maintaining shorter working length of the apical terminus have reported to be~     related with extrusion of infected debris, and some of them extruded less material and others~     extruded more.~      Periapical inflammation and postoperative flare-ups may result from apical extrusion of~     debris that is also referred to as the worm of necrotic debris A common outcome of the~     studies examining the amount of apically extruded debris was that the techniques involving a~     push-pull filing motion usually produce a greater mass of apical debris than those have~     rotational action Files which has reciprocating and in-and-out filing motion, may act as a~     piston, extruding more debris and irrigants. While the file with continuous rotation motion~     like a screw conveyor improving transportation of dentinal chips and debris coronally.~      In this study, investigators compare post-endodontic pain between these two systems. Mtwo (~     continuous rotation system) with safe-sider (reciprocating system). Therefore, the aim of~     this study is Evaluation of post-endodontic pain after root canal treatment with two rotary~     systems: Mtwo & safe-sider~   "
70511|NCT02644018|"~     The purpose of this study is to determine whether Ingavirin ® dosed 30 mg daily is effective~     and safe in the treatment of influenza and other acute respiratory viral infections in the~     course of standard therapy in 3-6 years old patients.~   "
70512|NCT02644005|"~     Prospective, bicentric observational study to assess a novel system for automated control of~     mechanical ventilation (Smart Vent Control, SVC) during general anesthesia.~   "
70513|NCT02643992|"~     Background: Peri-procedural management of direct oral anticoagulants (DOAC) is challenging.~     The optimal duration of pre-procedural discontinuation that guarantees a minimal DOAC~     concentration ([DOAC]) at surgery is unknown. The usual 48-hour discontinuation might not be~     sufficient for all patients.~      Objectives: To investigate the factors associated with per-procedural [DOAC]. To test the~     hypothesis that a 48-hour DOAC discontinuation is not sufficient to ensure a minimal~     perprocedural [DOAC], defined as [DOAC] < 30 ng/mL.~      Methods: Patients treated with DOAC, and requiring any invasive procedure will be included in~     this multicentre, prospective, observational study. [DOAC], will be measured during invasive~     procedure.~   "
70515|NCT02643966|"~     The purpose of this study is to evaluate the role of technologist-performed whole breast~     ultrasound for detecting breast cancer in the screening population of women with dense~     breasts.~   "
70516|NCT02643953|"~     Background: Nigeria has the second highest absolute number of maternal deaths and perinatal~     deaths in the world. The country contributes 14% of all maternal deaths worldwide, second~     only to India. Although all parts of the country are affected, most maternal, and perinatal~     deaths occur in the northeast and northwest geo-political zones, where women have limited~     access to evidence-based maternal and newborn health services. Affected women and families~     are mainly those who have little or no formal education, who are poor and marginalized, and~     who live in rural and sub-urban communities.~      Problem: Research carried out in various regions of Nigeria has shown that insufficient~     access to pregnancy health services is a major factor that places women at high risk of~     adverse maternal and perinatal outcomes. Maternal care provided within Nigeria's numerous~     local Primary Health Centres (PHCs) is an efficient and practical avenue for reaching~     vulnerable women and their newborn infants, and PHC use is strongly encouraged by the~     Nigerian Federal Ministry of Health.~      Research Question and Objective: The key research question and objectives are as follows: 1)~     To determine the main factors that prevent vulnerable women from using PHCs or receiving~     maternal and neonatal care therein; 2) To identify effective community level interventions~     for improving women's access to maternal health services, as a means to reduce maternal and~     perinatal morbidity and mortality in Nigeria.~      Methodology: This study will complete a community-based, multi-site project using a mixed~     methods approach. The project will be done in three sequential phases: A data gathering phase~     (Phase 1), an intervention phase (Phase 2), and the implementation of the findings (Phase 3).~     The study will be conducted over 54-months in six communities, and another six communities of~     similar status will serve as control sites. During Phases 1-3, surveys about maternal health~     services utilization will be carried out at baseline, midterm and completion points of the~     project.~      Potential Impact: Increasing women's access to evidence-based maternity care is likely a~     direct way to reduce maternal and neonatal mortality in Nigeria. The proposed project will~     determine how we can effectively increase access to PHCs, and then bring those findings into~     a policy and program format that can be applied across the country.~   "
70517|NCT02643940|"~     This study will be recording pressure wire readings from both blocked and narrowed arteries,~     to better guide treatment options; medications, stents or potentially bypass surgery, for~     patients with Chronic Total Occlusion (CTO).~   "
70518|NCT02643927|"~     The aim of this study was to assess and compare the efficacy of a standard 8-weeks protocol~     based on the Mindfulness Based Stress Reduction MBSR program versus a 4-week shortened~     version of the protocol in the improvement of wellbeing variables in a non-clinical~     population in Spain. The investigators initial hypothesis was that both protocols are~     efficacious but the standard 8-week performs better that the short one.~   "
70519|NCT02643914|"~     Nicotine is the most common drug of abuse in the United States, and has addiction strength~     comparable to cocaine, heroin, and alcohol. It is the primary addictive component of tobacco,~     and its use markedly increases risk for cancer, heart disease, asthma, miscarriage, and~     infant mortality. Addiction is thought to be caused primarily by the intersection of two~     components: 1) the impact of drug pharmacokinetics on the dynamics of dopamine response, and~     2) dysregulation of the brain's reward circuit. While the term 'dysregulated' tends to be~     used qualitatively within the neuroscience literature, regulation has a precise and testable~     meaning in control systems engineering, which has yet to be addressed in a quantitative~     manner by current neuroimaging methods or models of addiction. Current approaches to~     neuroimaging have primarily focused on identifying nodes and causal connections within the~     meso-circuit of interest, but have yet to take the next step in treating these nodes and~     connection as a self-interacting dynamical system evolving over time. Such an approach is~     critical for improving our understanding, and therefore prediction, of trajectories for~     addiction as well as recovery.~   "
70520|NCT02643901|"~     This study is designed to access the tolerability and Pharmacokinetic/Pharmacodynamic (PK/PD)~     of single subcutaneous (SC) injection of GW003 in healthy subjects.~   "
70521|NCT02643888|"~     The main task of this study includes analyses of the BCR-ABL1 (breakpoint cluster~     region/Abelson) gene and mutations in the BCR-ABL1 tyrosine kinase domain within flow-sorted~     stem cells from the bone marrow and/or peripheral blood specimens. To assess the germline~     configuration of the patient, DNA from fingernail clippings will be investigated.~   "
70522|NCT02643875|"~     Orthokeratology (ortho-k) is a clinical technique that uses reverse geometry rigid gas~     permeable contact lens exerting positive pressure on the central cornea to temporary reduce~     refractive error. The investigators have shown that this treatment is effective for myopic~     control in low to high myopes, with and without astigmatism. Most designs of ortho-k lenses~     in the market are fitted based on the Jessen formula. The compression factor was introduced~     to compensate for regression of the ortho-k effect during the no lens-wear period, so that~     the wearer can obtain clear distance vision throughout the day and most lens designs use a~     compression factor of 0.50-0.75D. However, in a retrospective study (mixed brands of ortho-k~     lenses), showed that most patients did not achieve an over-correction of 0.75D. In order to~     achieve an over-correction of 0.75D, an extra flattening power of about 1.50D instead of~     0.75D should be be targeted. The increased compression factor is expected to increase the~     target reduction and it may play a role in myopic control and providing a higher successful~     rate in fitting ortho-k lenses.~   "
70523|NCT02643862|"~     This is a pilot randomized, double-blind, placebo controlled study which will be conducted at~     a single center. All participants will receive oral immunotherapy for their specific food~     allergies (limited to 5 of those food allergens in IND 14831). In a 3:1 ratio, 36*~     participants will receive Xolair for 16 weeks while 12* will receive corresponding placebo~     instead of Xolair. 12 controls will be enrolled who will receive no OIT and no Xolair. These~     12 controls are not part of the randomization. The total number of participants randomized to~     the two arms is 48*.~   "
70524|NCT02643849|"~     The Spanner is being evaluated for use to manage voiding dysfunction and lower urinary tract~     symptoms in subjects to achieve bladder drainage in men unfit for other treatments.~   "
70525|NCT02643836|"~     The objectives are to evaluate impact of Pulsed electromagnetic field (PEMF) therapy on~     patients with Post-Concussive Syndrome with Rivermead Post Concussion Symptom Questionnaire~     (RPQ) as a primary outcome, followed by fatigue and mood as second and tertiary outcomes~     respectively. The investigators will also investigate brain tissue activity and oxygenation~     by evaluating brain wave activity via non-invasive quantitative electroencephalogram and near~     infrared spectroscopy testing pre and post study to better understand the metabolic effect of~     the PEMF intervention.~      The investigators hypothesize that the PEMF treatment will have an effect on improvement of~     brain metabolism as measured by Near Infrared Spectroscopy which will in turn assist with~     improvement of the chronic symptoms of cognitive deficits, mood and fatigue as related to~     Post-Concussive Syndrome.~   "
70526|NCT02643823|"~     The purpose of this study is to evaluate the safety and efficacy of human umbilical cord~     mesenchymal stem cell(hUC-MSC) for Rheumatoid Arthritis.~   "
70527|NCT02643810|"~     In this controlled trial, patients with tetralogy of Fallot will be randomized to either~     interval training, continuous training, or usual care groups.~   "
70531|NCT02643758|"~     The purpose of this study is to evaluate whether bifocal soft contact lenses (CLs) with low~     addition and nasally decentered optical zone are effective in controlling myopic progression~     in children. Visual manipulations induced by multifocal soft CLs with high addition have been~     shown to inhibit eye growth and myopia development in children by recent studies. Several~     theories have been proposed including alteration in peripheral defocus, reduced accommodation~     demand, alterations in binocular vision status and increased ocular higher order aberrations.~     However, those theories remain to be proven and the optical properties and performance of~     multifocal soft CLs have not been investigated in children.~   "
70532|NCT02643745|"~     Acute kidney injury (AKI) is a frequent complication after cardiac surgery. Its incidence~     ranges from 19 to 44% depending on the study and which definition is used: Acute Kidney~     Injury Network (AKIN) classification or RIFLE criteria (Risk, Injury, Failure, Loss,~     End-Stage Kidney Disease) based on serum creatinine and urine output.~      AKI is associated with increased mortality, more complications, a longer stay in the~     intensive care unit and hospital, and increased health care costs. Moreover, the patients who~     require renal replacement therapy (RRT) have the highest mortality and complications1.The~     mortality risk in patients developing acute renal dysfunction after cardiac surgery increases~     by approximately 40%, while the overall mortality rate after cardiac surgery ranges between~     2% and 8%.~      There are some well-known risk factors associated with AKI, including baseline patient~     characteristics (age and comorbidities), need of perioperative blood transfusion or presence~     of previous chronic kidney disease. The main objective of this study is to evaluate if a~     nephrologist management and control of potential risk factors of renal disease can be used to~     prevent AKI, thereby minimizing the risk of need RRT, reducing costs and improving survival~     in this patients.~   "
70533|NCT02643732|"~     This is a small randomised-controlled trial (RCT) using methylphenidate as a treatment for~     clinically-significant fatigue in sarcoidosis patients with stable disease. The primary~     outcomes are feasibility, aimed at determining factors that will influence the design a~     future, larger RCT, which will be powered to look at clinical efficacy of the intervention.~   "
70534|NCT02643719|"~     Randomized pilot feasibility study evaluating the impact of introducing behavioral treatment~     for migraine in the Emergency Department (ED) and prescribing migraine preventive medications~     in the ED. The study will examine the effect of these treatments, both individually and in~     combination, on pain severity and headache-related disability. This study is designed to~     examine the feasibility of comparing four interventions for ED patients presenting with~     migraine. Group 1: Starting topiramate; Group 2: Doing a brief behavioral intervention; Group~     3: Treating with combination therapy of topiramate and behavioral intervention; and Group 4:~     Standard of Care.~   "
70535|NCT02643706|"~     The purpose of this clinical trial is to investigate the relationship between the gene~     polymorphism of aldehyde dehydrogenase 2 and contrast induced nephropathy and its mechanism.~   "
70536|NCT02643693|"~     This study will provide an initial assessment of the acceptability of the Nicotine Lactate~     Delivery System (P3L) after ad libitum use and the ability of combustible cigarette (CC)~     smokers to use P3L to maintain their customary nicotine intake.~      The pharmacokinetics (PK) and pharmacodynamics (PD, i.e., subjective effects) profiles, will~     be evaluated as well as the safety and tolerability of the P3L.~   "
70537|NCT02643680|"~     1. The wound healing time of STSG donor sites which are treated with the novel biocellulose~          wound dressing containing silk sericin and PHMB should be less or equal to Bactigras®.~        2. The wound quality of STSG donor sites which are treated with the novel biocellulose~          wound dressing containing silk sericin and PHMB should be less or equal to Bactigras®.~        3. The amounts of STSG donor site infection which are treated with the novel biocellulose~          wound dressing containing silk sericin and PHMB should not be more than Bactigras®.~        4. The pain level of STSG donor sites which are treated with the novel biocellulose wound~          dressing containing silk sericin and PHMB should be less or equal to Bactigras®.~        5. Adverse events which are occurred from the novel biocellulose wound dressing containing~          silk sericin and PHMB treatment for STSG donor sites and Bactigras® will be reported, if~          they occur.~   "
70538|NCT02643667|"~     30-40% of patients who undergo radical prostatetecomy (RP) with curative intent for their~     localized prostate cancer experience relapse of their disease. Thus, improved therapeutic~     approaches are needed in this patient population. Enhancing the patient's anti-tumor immune~     response prior to surgery may improve long-term outcomes following RP.~   "
70539|NCT02643654|"~     Hidradenitis suppurativa (HS) is a chronic inflammatory skin disorder. Although adalimumab is~     recently licensed for moderate to severe HS, many cases fail to respond or relapse during~     treatment. Favorable outcomes from a recently conducted double-blind randomized clinical~     study on the efficacy of anakinra, one interleukin(IL)-1alpha blocker, in hidradenitis~     suppurativa (HS), led to validate the efficacy of MABp1, a true human antiIL-1α antibody in~     these cases.~   "
70540|NCT02643641|"~     BM32 is a product for immunotherapy of grass pollen allergies. It consists of 4 different~     recombinant proteins (BM321, BM322, BM325 and BM326) adsorbed on alhydrogel. This~     prospective, double-blind. placebo controlled, mono-centric trial investigates the levels of~     allergen specific IgG antibodies following 3, 4 or 5 subcutaneous injections before the grass~     pollen season.~   "
70541|NCT02643628|"~     This is an open-label, randomized, multicenter, prospective trial assessing the efficacy and~     safety of microneedling treatment alone vs. microneedling treatment followed by treatment~     with Bellafill for correction of distensible atrophic facial acne scars.~   "
70542|NCT02643615|"~     Post-operative visual loss (POVL) following non-ocular surgical procedures is an infrequent~     but severe complication. Little is understood about this complication, but most cases seem to~     result from loss of blood flow to the optic nerve. This is a pilot, single center,~     prospective, randomized, two-arm study involving 20 subjects at The Ohio State University~     Wexner Medical Center who are scheduled to undergo spine surgery that requires prone position~     and at least two hours of general anesthesia or total intravenous anesthesia (TIVA) and~     intraoperative neurophysiological monitoring. Patients will be randomized to either general~     anesthesia or TIVA, and wear the SightSaver device to monitor visual evoked potentials (VEPs)~     during surgery in order to detect possible changes in optic nerve function that may lead to~     POVL. We hypothesize that this new, flexible, disposable device will yield better results and~     more patient satisfaction than devices currently used for visual monitoring during prone~     spine surgeries.~   "
70543|NCT02643602|"~     Contrast-induced nephropathy (CIN) is the third most frequent cause of hospital-acquired~     acute renal failure. Different regimes in the prophylaxis of CIN have been investigated in~     the last years. Recent Meta-analysis show a reduced incidence of CIN when theophylline is~     administered to the patients especially in patients with already existing renal impairment.~     Furthermore hydration with bicarbonate seems to to be superior to hydration with sodium~     chloride alone. The combination of the two prophylaxis has not been investigated yet.~      Aim of this prospective randomized trial is to investigate the effect of hydration with~     sodium bicarbonate compared to saline in addition to theophylline prophylaxis which all~     patients receive.~   "
70544|NCT02643589|"~     The purpose of this study is to compare the incidences of GVHD in haploidentical~     hematopoietic stem cell transplant recipients receiving different dose of antithymocyte~     globulin (ATG) for acute graft-versus-host disease(aGVHD) prophylaxis. The investigators'~     first objective was to investigate the optimal dose of ATG for aGVHD.~   "
70545|NCT02643576|"~     This highly innovative experimental trial is designed to examine the independent and joint~     effects of prohibiting the use of SNAP-like benefits to purchase foods high in discretionary~     calories and offering an incentive to encourage the purchase of more healthful foods.~   "
70546|NCT02643563|"~     Severe pain following shoulder surgery is common and remains a major challenge. The~     interscalene nerve block is well suited for operations on the shoulder or upper arm, for~     providing surgical anesthesia as well as prolonged effective postoperative analgesia.~      Modern ultrasound guided ISB (US-ISB) allows for more accurate, targeted deposition of local~     anesthetic. The current trend is to lower the volume of local anesthetic for~     ultrasound-guided interscalene block in order to reduce potential complications such as~     phrenic nerve paralysis and local anesthetic toxicity. However, at low volumes the analgesic~     duration of the block could be compromised. Studies to elucidate the best local anesthetic~     agent, concentration and adjuncts to prolong analgesia at low volumes are needed. Ropivacaine~     and Bupivacaine are long acting local anesthetics commonly used for peripheral nerve blocks,~     however, there are no studies comparing their analgesic duration in the setting of low volume~     interscalene block to date.~      This study will investigate the analgesic duration of 0.5% Ropivacaine versus 0.5%~     Bupivacaine with 1:200,000 epinephrine versus 1% Ropivacaine for low volume US-ISB.~      This study aims to conduct a comparison of the duration of post operative analgesia achieved~     by these agents, hence allowing the appropriate local anesthetic agent and concentration~     selection in low-volume techniques.~   "
70547|NCT02643550|"~     The objective of this study is to evaluate in a 3 +3 design, the safety of escalating doses~     of IPH2201 given IV in combination with cetuximab in patients who have received prior~     systemic regimen(s) for recurrent and/or metastatic squamous cell carcinoma of the head and~     neck (SCCHN). A cohort expansion will evaluate antitumor activity of the combination.~   "
70548|NCT02643537|"~     The aim of this study was to evaluate the clinical outcome of this rare injury with special~     emphasis on associated pathologies. Additionally, we aimed to develop an algorithm for the~     diagnosis of associated pathologies following LEH.~   "
70549|NCT02643524|"~     The purpose of the study is to determine if patients wearing a CAM walker boot have a change~     in weight compared to patients who wear a CAM boot and are provided nutritional and upper~     body exercise information.~   "
70550|NCT02643511|"~     Whole gland LDR brachytherapy has been a well established modality of treating low risk~     prostate cancer. Treatment in a focal manner has the advantages of reduced toxicity to~     surrounding organs.~      AIM: To determine the utility of focal LDR brachytherapy in form of hemiablative treatment~     for localized prostate cancer demonstrating the feasibility of the delivery of the~     prescription dose to the half of the prostate in terms of meeting standard dosimetric~     parameters while respecting same or lower tolerance doses of adjacent normal organs.~      To determine acute and late rectal, urinary and sexual toxicity after this procedure.~      To assess the change from baseline in QOL indicators at specific time intervals using~     validated international questionnaires [International Prostate Symptom Score ( IPSS),~     International Index of Erectile Function ( IIEF ), Expanded Prostate Cancer Index (EPIC)]~     after this treatment.~      To evaluate the local tumour control in terms of biopsy outcomes after focal brachytherapy 36~     months after the treatment.~      To compare target coverage and relative doses to the rectum and the urethra for the same~     patient performing a hemigland treatment planning vs Whole gland treatment planning.~      STUDY DESIGN: Multi-institution prospective trial to determine whether hemiablative treatment~     with LDR for prostate cancer is dosimetrically safe and feasible.This study will record data~     for 20 patients with ipsilateral with low and low tier intermediate risk disease.The study~     will record quality of life parameters in particular in terms of urinary, rectal and sexual~     function side effects.~      INTERVENTION:~        -  Baseline Transperineal Template guided mapping prostate biopsy with >20 cores (not~          required if already performed)~        -  Multiparametric MRI within the 3 months prior to registration and at 18 & 36 months.~        -  Hemigland prostate region will be targeted with the prescription dose and receive 144 Gy~          of Iodine125 (I125).~        -  The quality of life assessment will focus on erectile function, urinary function, bowel~          function, and general health related quality of life~        -  Postimplant CT Planning day 30 after the implant for quality assurance.~      MEASUREMENT OF ENDPOINTS :~      Dosimetric parameters record, Toxicity and QOL evaluation forms, PSA follow up and biopsies~     at 36 months to assess local control.~   "
70551|NCT02643498|"~     The purpose of this study is to find out the maximum dose of SBRT that can be safely given~     after chemotherapy for treatment of pancreatic cancer that cannot be removed surgically.~   "
70552|NCT02643485|"~     Static pedobarography is routinely used for pre- and postoperative questions regarding~     plantar foot pressure. This Investigation does insufficiently detect dynamic Forces. Hence,~     dynamic pedobarography might give some important insights in detecting plantar foot pressure~     after forefoot reconstruction.~   "
70553|NCT02643472|"~     BACKGROUND: Annually >400,000 US newborns require neonatal intensive care unit (NICU)~     care.1/3 will require ongoing or specialty care after discharge. Some NICU graduates can be~     classified as children with special health care needs (CSHCN) who will require health and~     related services of a type or amount beyond that required by children generally. NICU parents~     report increased anxiety and stress during their stay and transition home from the NICU.~     Short-term peer-to -peer programs during hospitalization decrease stress, anxiety and~     depression for mothers, however, no studies have evaluated the effects of long term~     post-discharge peer support. Children's National (CN) provides medical home services to CSHCN~     through its Parent Navigator Program (PNP). Parent Navigators (PNs) are CSHCN parents who~     provide peer emotional support, access to community resources, and assistance with navigating~     complicated health systems. NICU graduates and their caregivers may benefit from support~     provided by PNs after discharge. No data regarding the impact of PNs on patient and family~     outcomes of the NICU graduate are available.~      OBJECTIVE: To assess the impact of a PNP on a parent's self-efficacy, stress, anxiety,~     depression; infant health care utilization, and immunization status.~      METHODS: 300 NICU graduates will be randomized to receive either PN for 12 months~     (intervention group) or usual care (comparison group). Baseline data at 1 week, 1, 3, 6, and~     12 months after discharge will be collected from caregivers in both groups including scales~     for self-efficacy, stress, anxiety, and depression, infant healthcare utilization and~     immunization status. Outcomes will be compared at 12 months.~      PATIENT OUTCOMES (PROJECTED) The study outcomes are parental self-efficacy, stress, anxiety,~     and depression; infant health care utilization and immunization status.~      ANTICIPATED IMPACT Prior studies utilizing small samples have suggested that peer support in~     the NICU can reduce anxiety and depression in caregivers. It is unclear whether peer support~     after discharge, when a family is faced with the total care of their child without structured~     supports, can significantly impact parents' ability to care for their child. The~     investigators anticipate that this simple intervention will increase self-efficacy in~     caregivers, reduce stress, anxiety, and depression, in turn resulting in improved health~     outcomes for their child.~   "
70556|NCT02643433|"~     Japanese encephalitis (JE) is the leading cause of viral neurological disease and disability~     in Asia. A live attenuated vaccine (LJEV) manufactured in China has several advantages over~     other JE vaccines such as one dose schedule, using for infants, and the cheaper cost. Because~     the LJEV has been prequalified by the World Health Organization (WHO) in 2013, it will likely~     be used in other countries, and possibly co-administered with the first dose of~     measles-containing vaccine (MCV) to ensure early protection and reduce additional vaccination~     visits.~      The evidence for immunogenicity and safety of co-administration of LJEV with MCV is limited.~     Only one study conducted in the Philippines examining the co-administration of MCV with LJEV~     among 9 months infants, the results showed the proportion of achieved sero-protection against~     measles following MCV (96%) was slightly lower than in the MCV-only group (100%), and the~     measles antibody titres were also slightly lower in the co-administration group. Due to~     limited evidence available, the WHO position paper of measles vaccines has encouraged further~     investigation on the possible impact of co-administration of LJEV on measles vaccine~     effectiveness.~      In China, Measles-Rubella combined vaccine (MR) and LJEV is given at 8 months of age~     nationally. Considering China is reaching towards the goal of measles elimination, it will be~     important to conduct a study to compare the immunogenicity of MR administered alone or with~     LJEV, and also evaluate the safety and tolerability of LJEV administered with MR among 8~     months infants.~      This study is a prospective, randomized, open-label, multi-center study enrolling infants~     aged 8 months. Basic demographic information of the infant will be taken and blood samples~     will be collected at enrollment (baseline) and at 6weeks following administration of MR, the~     measles antibodies will be measured, and compare seroconversion rates to assess for~     non-inferiority. All infants will be monitored for adverse events after MR.~   "
70557|NCT02643420|"~     The purpose of this study is to compare the efficacy of a single dose of SPI-2012 with~     pegfilgrastim (Neulasta [NDC 55513-190-01] manufactured by Amgen) in patients with~     early-stage breast cancer receiving docetaxel and cyclophosphamide (TC), as measured by the~     Duration of Severe Neutropenia (DSN) in Cycle 1.~   "
70558|NCT02643407|"~     To compare the efficacy and safety of docetaxel plus nedaplatin with docetaxel plus cisplatin~     in managment of advanced/relapsed squamous cell lung cancer.~   "
70559|NCT02643394|"~     The comparative efficacy of intravenous (IV) to oral (PO-'per os') acetaminophen in the~     management of postoperative pain is understudied and largely unknown. In this observer~     blinded randomized clinical trial, investigators aim to determine the comparative efficacy of~     PO (preoperative) vs. IV (intraoperative) acetaminophen in a sinus surgery population.~   "
70560|NCT02643381|"~     Patients who are having problems breathing sometimes require placement of a breathing tube in~     their mouth and windpipe. The purpose of this breathing tube is to save the patient's life.~     It is common to give the patient a medication to sedate him or her before the breathing tube~     is placed. For patients who are gravely ill two medications are commonly used: etomidate or~     ketamine. Both medications have risks and benefits. Researchers at UT-Southwestern Medical~     Center and Parkland Memorial Hospital would like to do a study to figure out which one is~     better for our patients.~   "
70561|NCT02643368|"~     This is an open-label phase IV, randomized controlled trial of mOPV2 alone and mOPV2 along~     with IPV. This trial will assess the impact on type 2 immunogenicity by reducing the interval~     between mOPV2 doses. The trial will also evaluate any difference in immunogenicity when the~     first dose of mOPV2, in a two dose schedule with a four week interval, is administered~     simultaneously with IPV.~   "
70562|NCT02643355|"~     Withdrawal from opioids is a clinical scenario that emergency department physicians encounter~     frequently. Patients who present with opioid withdrawal display symptoms such as agitation,~     anxiety, myalgias, abdominal pain, diarrhea, nausea, and vomiting. Currently, the standard~     treatment for opioid withdrawal is clonidine (an alpha-2 adrenergic agonist), as well as~     supportive cares (anti-emetics, intravenous fluids). Olanzapine is an atypical antipsychotic~     that is given frequently in the ED for many of the same symptoms that are seen in patients~     who are experiencing opioid withdrawal, however its use in this toxidrome has never been~     studied. The hypothesis of this study is that olanzapine is a safe and efficacious option~     when compared to clonidine for the treatment of opioid withdrawal in the emergency~     department.~   "
70563|NCT02643342|"~     This is a two-year longitudinal study investigating the optical and structural effects of~     increased compression factor of orthokeratology lens on eyes and the corresponding effect on~     change in choroidal thickness and therefore myopic control.~   "
70564|NCT02643329|"~     The purpose of the study is to compare the bioavailability of a generic product of gliclazide~     (Product Name: BF-Gliclazide Tablet 80mg, Manufactured by Bright Future Pharmaceuticals~     Factory O/B Bright Future Pharmaceutical Laboratories Limited) with that of reference product~     (Product Name: Diamicron 80mg Tablet, Manufactured by Les Laboratoires Servier Industrie,~     France) when administered to healthy volunteers under fasting conditions. The plasma~     pharmacokinetic data of gliclazide obtained from two formulations will be used to access the~     interchangeability of the products.~   "
70565|NCT02643316|"~     Comparison of quality of preparation of colonoscopy in patients taking same day 4L~     preparation vs. 4 L split dose preparation in patients scheduled for an afternoon colonoscopy~     procedure.~   "
70566|NCT02643303|"~     This is an open-label, multicenter Phase 1/2 study of the CTLA-4 antibody, tremelimumab, and~     the PD-L1 antibody, durvalumab (MEDI4736), in combination with the tumor microenvironment~     (TME) modulator polyICLC, a TLR3 agonist, in subjects with advanced, measurable,~     biopsy-accessible cancers.~   "
70567|NCT02643290|"~     Aim of the study is to evaluate a new brace that has become available, the Peak Scoliosis~     Brace (Aspen Medical Products) designed to alleviate pain for adult patients with chronic~     pain secondary to scoliosis.~      20 adults with back pain secondary to Idiopathic Scoliosis will be recruited. The sample size~     was calculated considering the data collected during the development of the brace in the US.~     Patients will be evaluated at baseline immediately before starting with the brace and after 4~     weeks and 6 months. The brace must be worn for at least 2-4 hours per day.~      At each evaluation they will be asked to fill the questionnaires, to be used as outcome~     measure of the results.~   "
70581|NCT02643108|"~     Non-parous women with a live singleton pregnancy in cephalic presentation past 34 gestational~     weeks will be randomized to lateral episiotomy or no episiotomy when operative vaginal~     delivery by vacuum extraction is indicated. Primary outcome is clinically diagnosed obstetric~     anal sphincter injury (OASIS) of any degree.~   "
70582|NCT02643095|"~     This study will be done with subjects who already habitually wear scleral contact lenses. The~     study lens is made with a material that is already widely available and has a new design. It~     will be fit by the investigators and will be assessed and at one week and 1 month.~   "
70583|NCT02643082|"~     Study to Evaluate the Effects of PT003 and Placebo MDI on Specific Image Based Airway Volumes~     and Resistance With Moderate to Severe COPD.~   "
70568|NCT02643277|"~     In India, the high diabetes prevalence and cost of its management relative to their personal~     income render the country an appropriate environment to seek and test new, less expensive~     aids to care. Education and motivation to induce behavioural modification, are important~     components of care. Conventional diabetes education programmes involving personal contact~     methods are useful but expensive. Compliance with medications is also important and there are~     data to suggest that compliance is low in people with established type 2 diabetes (there is~     little information on those with recently diagnosed disease). Mobile phones could provide an~     inexpensive and scaleable delivery vehicle for components of care. There are now more than 5~     billion wireless subscribers and 70% of them live in low and middle income countries. Mobile~     phone ownership is high in India and an increasing proportion now has Mobile phones and/or~     home computers. The investigators plan a clinical trial in India to assess whether there is~     benefit from an enhanced text message intervention delivered by mobile phone in people newly~     diagnosed with Type 2 diabetes. The message content will be directed to behavioural~     modification, as with our diabetes prevention studies, and will attempt to improve compliance~     with drug therapy and other aspects of care, as with our studies in people with established~     diabetes. The investigators shall compare effects on glycaemia, other cardiovascular risk~     factors, lifestyle behaviour and quality of life, with those observed in people with type 2~     diabetes receiving standard care.~   "
70569|NCT02643264|"~     The purpose of this study is to investigate the effects of repetitive transcranial magnetic~     stimulation (rTMS) targeting the insula on alcohol use and neural responses in~     alcohol-dependent patients.~   "
70570|NCT02643251|"~     The study will include three (3) phases: Screening Phase, Treatment Phase, and Follow-up~     Phase. Subjects who qualify to participate will apply study drug to their feet three times~     daily and will record their daily pain scores using an interactive voice response system~     (IVRS) during the Treatment Phase for 12 weeks. Approximately 100 adult subjects will be~     randomized to receive Clonidine Gel or Clonidine Gel Comparator.~   "
70571|NCT02643238|"~     The purpose of this study is to evaluate the use of an artificial vision system called~     Brainport system in blind patients To investigate visual, and oculomotor (eye motion)~     mechanisms involved in the use of the Brainport system.~   "
70572|NCT02643225|"~     The aim of this work is the prediction of fetal macrosomia by measuring:~        1. HbA1C.~        2. Umbilical cord thickness.~        3. Interventricular septum thickness.~   "
70573|NCT02643212|"~     The main objective of the study will determine if patients with liver cirrhosis,~     anticoagulation free survival improves hypertension decompensation portal and / or~     transplantation without serious side effects. For it is conduct a double-blind multicenter~     clinical trial in which patients will be randomized to receive Rivaroxaban or placebo. It~     included 160 patients with liver cirrhosis and insufficiency mild to moderate hepatic. It~     will also analyze and develop secondary endpoint portal vein thrombosis. The confirmation of~     our hypothesis would lead to a radical change in treatment of patients with cirrhosis include~     treatment with Rivaroxaban in its drove.~   "
70574|NCT02643199|"~     The aim of the study to evaluate Five-Dimensional Ultrasound in automated assessment of the~     fetal heart from 20-36 weeks of gestation.~   "
70575|NCT02643186|"~     The study aims at comparison between the effect of preoperative misoprostol and bilateral~     uterine artery ligation regarding their effect to decrease blood loss in transabdominal~     myomectomy.~   "
70576|NCT02643173|"~     The investigators will verify the prognosis of hepatocellular carcinoma (HCC) according to~     the main anesthetic agents used for the general anesthesia.~   "
70577|NCT02643160|"~     The purpose of this study is to analyze if trunk training has effects on trunk, upper, lower~     extremity motor functions in children with spastic Cerebral Palsy. Second purpose is to~     analyze the relation between trunk control and prematurity, birth weight, upper and lower~     extremity motor functions in children with spastic Cerebral Palsy.~   "
70578|NCT02643147|"~     Worsening renal function (WRF) is a frequent finding in patients with decompensated acute~     heart failure (AHF) and it is associated to increased length of hospitalization and higher~     morbidity and mortality. Traditionally, WRF in AHF setting has been attributed to low cardiac~     output, but recent evidence also suggests venous congestion play a crucial role. Loop~     diuretics are the mainstay treatment of AHF, but their use traditionally has been associated~     to WRF, but also renal function improvement in patients with unequivocal signs of congestion.~     Nevertheless, traditional symptoms or signs of patients with AHF have shown a limited~     accuracy to neither identify nor quantify the degree of venous congestion. Recent authors~     have reported that plasma levels of antigen carbohydrate 125 (CA125) are closely related to~     the degree of venous congestion.~      The investigators hypothesize that CA125 may have a role for identifying the hyperhydrated~     (High CA125) patients that need high loop diuretic doses, and those with normal CA125 values~     needing low loop diuretic doses. In this randomized study (1:1) the investigators seek to~     evaluate whether a CA125 loop diuretic guided management therapy is superior to a standard~     strategy. The primary endpoint is the magnitude of changes of renal function at 24 and 72~     hours after initiation of intravenous diuretic in an acute worsening of heart failure~   "
70579|NCT02643134|"~     The traditional stone row method comprises increasing exercise, drink lots of water, drug row~     of stone and stone row position. External physical vibration lithecbole(EPVL) is a~     non-invasive device active row of stone, the researchers hope that through this test~     prospective clinical study to evaluate the effectiveness of in vitro physical vibration row~     of stones after extracorporeal shockwave lithotripsy(ESWL) treatment of stones discharged,~     thereby improving after ESWL stone clearance rate.~   "
70580|NCT02643121|"~     Presepsin (formerly CD14), is a glycoprotein receptor occurring at the surface of~     monocytes/macrophages. CD14 binds to lipopolysaccharide (LPS) complexes and LPS binding~     protein (LPB), which triggers the activation of toll-like receptor 4 (TLR4), resulting in the~     production of numerous pro-inflammatory cytokines. Following Presepsin activation by~     bacterial products, the CD14 complex is released in the circulation as its soluble form~     (sCD14), which in turn is cleaved by a plasma protease to generate a sCD14 fragment called~     sCD14-subtype (sCD14- ST). Plasma levels of sCD14 can be measured using an automated~     chemo-luminescent assay (PATHFAST).~   "
73959|NCT02598804|"~     The primary purpose is to evaluate the benefit of an education action of exercise on the~     level of physical activity in patients with knee osteoarthritis with the waning of a spa~     treatment for three weeks, three months after the start of the cure.~   "
70584|NCT02643069|"~     Frailty is the main risk factor for the development of incident disability in older people~     and one of the most important for other adverse outcomes (death, hospitalisation, falls, and~     permanent institutionalisation).~      Although frailty is a frequent condition in older adults who attend hospitals, little is~     known about its true prevalence in different settings of care. Better knowledge of this issue~     will inform the rational design of more effective strategies aimed at providing fitted care~     for these patients. Thus, the current study will potentially have impact on the quality of~     care for frail patients by revealing the prevalence of frailty in different settings of care,~     the difficulties in detection and management of frailty in these settings and the best~     instruments to detect frailty.~      The investigators proposal brings together 6 partners in the European Union (EU) from three~     countries, with the common aim of studying the feasibility of a program to detect frail older~     patients in high risk clinical settings.~   "
70585|NCT02643056|"~     Phase II, multicenter, open labelled, uncontrolled study to evaluate the efficacy and safety~     profile of panitumumab in patients affected by Head and Neck cancer after at least one~     cisplatin or carboplatin-based chemotherapy. A translational research study is also planned~     to evaluate EGFR status by FISH, KRAS, B-RAF, HRAS, NRAS and PIK3CA mutation by DNA~     sequencing, PTEN protein expression by immunohistochemistry, and HPV genotyping by reverse~     hybridization.~      Panitumumab is administered iv on days 1 and 15 of a 28 days cycle, until progressive~     disease, unacceptable toxicity, pregnancy, or patient's refusal~   "
70586|NCT02643043|"~     This comprehensive genomic analysis and biospecimen repository study incorporates Next~     Generation Sequencing (NGS) of archival tumor tissue from 200 subjects with metastatic~     urothelial cancer in support of several parallel goals. The immediate goal involves~     generation of a comprehensive report identifying subject specific genetic mutations and/or~     alterations based on NGS. Additionally, DNA and RNA extracted from tumor specimens and any~     remaining blocks/slides from the NGS will be stored for future research. Long-term, the goal~     of this endeavor is to support collaborative translational research projects in metastatic~     urothelial cancer by allowing investigators to interrogate abstracted coded clinical data~     linked to data from any biospecimen studies.~   "
70587|NCT02643030|"~     The purpose of this study is to evaluate the effects of hypercapnia on hemodynamics and~     cerebral oxygenation during shoulder arthroscopy.~   "
70588|NCT02643017|"~     Investigate the effects of dexmedetomidine on postoperative cognitive function in patients~     undergoing shoulder arthroscopy with beach chair position under desflurane anesthesia.~   "
70589|NCT02643004|"~     The objective of this study is to compare the clinical performance of senofilcon A lens with~     the stenfilcon A lens each for one week of daily disposable wear.~   "
70590|NCT02642991|"~     This study will investigate performance criteria over one week of daily wear to determine if~     the Study Test contact lens performs equivalently to the comfilcon A contact lenses in terms~     of measurement and subjective ratings of visual performance.~   "
70591|NCT02642978|"~     The purpose of this study is to evaluate the safety and effectiveness of robot-assisted~     simultaneous resection in selected patients with sigmoid colon cancer or rectal cancer liver~     metastases, and compared with the traditional open procedure.~   "
70592|NCT02642965|"~     This phase I/II trial studies the side effects and best dose of liposomal~     cytarabine-daunorubicin CPX-351 (CPX-351) when given with fludarabine phosphate, cytarabine,~     and filgrastim and to see how well they work in treating younger patients with acute myeloid~     leukemia that has come back after treatment (relapsed) or is not responding to treatment (is~     refractory). Liposomal cytarabine-daunorubicin CPX-351 is made up of two chemotherapy drugs,~     cytarabine and daunorubicin hydrochloride, and works to stop cancer cell growth by blocking~     the cells from dividing. Drugs used in chemotherapy, such as fludarabine phosphate and~     cytarabine, work in different ways to stop the growth of cancer cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Filgrastim may~     increase the production of blood cells and may help the immune system recover from the side~     effects of chemotherapy. Giving liposomal cytarabine-daunorubicin CPX-351 followed by~     fludarabine phosphate, cytarabine, and filgrastim may be a better treatment for patients with~     relapsed acute myeloid leukemia and may cause fewer side effects to the heart, a common~     effect of other chemotherapy treatments for acute myeloid leukemia.~   "
70593|NCT02642952|"~     The purpose of this study is to evaluate by non-invasive methods the change in central~     hemodynamics and arterial stiffness produced by grafts and endografts after abdominal aortic~     aneurysm repair.~      Our main goal is to measure the changes in:~      Augmentation index, central blood pressure, pulse wave analysis, pulse wave velocity.~   "
70594|NCT02642939|"~     This is a non-randomized, multicenter, single-stage phase II study of mifepristone in~     patients with advanced or metastatic NSCLC who have failed two or more previous chemotherapy~     regimens.~      The Investigator plans to enroll 18 evaluable patients in Stage 1, and additionally up to 22~     evaluable patients in Stage 2 for a total of 40 evaluable patients. Participants will be~     followed for overall survival. Current salvage therapy in advanced NSCLC achieves a median~     progression free survival time of 10 weeks and overall survival of 10 months. The~     Investigator would like to provide evidence that mifepristone will increase the median~     progression-free survival time to 15 weeks and overall survival time of 16 months.~   "
70595|NCT02642926|"~     Since the development a few years ago of bipolar energy in the surgery by operative~     hysteroscopy, the hysteroscopic treatment of menorrhagia by endometrial ablation can be~     achieved either by the use of monopolar or bipolar current, in parallel with other techniques~     labelled as 'second generation' (microwave, radio frequency, thermal destruction ...)~     treating the uterine cavity.~      It seems that the use of the bipolar energy decreases the rate of adhesions but prospective~     data on the success rate after bipolar endometrial ablation are poor and there is currently~     no recommendation as to the choice of technique to use. No prospective assessment exists to~     date in the literature to compare the difference in efficacy on bleedings when using~     monopolar or bipolar current. The goal of this study is to compare these two energies, by~     measuring the amount of bleeding calculated by the Higham score 12 months after the~     intervention.~   "
71128|NCT02635971|"~     This study aims to explore the efficacy and safety of intra- arterial infusion of gemcitabine~     and oxaliplatin in locally advanced pancreatic cancer. This protocol is overseen by the Fudan~     University Institutional Review Board which has Federal Wide Assurance through the U.S.~     Department of Health & Human Services (Approved: April 25, 2002).~   "
70596|NCT02642913|"~     The purpose of this study is to test the safety of enzalutamide with or without sorafenib at~     different doses. Enzalutamide is approved by the Food and Drug Administration (FDA) for the~     treatment of advanced prostate cancer. Enzalutamide blocks a protein called the androgen~     receptor. Experiments on liver cancer cells and animal models show that blocking the androgen~     receptor causes liver cancer to stop growing. Enzalutamide has not been approved to treat~     liver cancer. The investigators want to see if enzalutamide is safe for patients with liver~     cancer who have had their tumors grow on sorafenib. The investigators also want to see how~     safe and effective sorafenib and enzalutamide are for liver cancer patients that have never~     been treated with sorafenib. This is the first time enzalutamide and sorafenib are being used~     together. This treatment may not help treat the participant's cancer.~   "
70597|NCT02642900|"~     Candida albicans is the most prevalent species in denture-related stomatitis (DS). There are~     several treatment options for this condition, including the use of antifungal agents such as~     nystatin and miconazole. The side effects and the increasing number of resistant species~     caused by the use of these drugs encourage the development of alternative therapies.~     Photodynamic Therapy (PDT) has been used as a promising treatment of stomatitis. In this~     randomized clinical trial, the effectiveness of PDT was evaluated. Patients in this study~     were allocated to two groups. One group was treated with nystatin, and the other group was~     treated with PDT.~   "
70598|NCT02642887|"~     Objectives: To clinically evaluate the healing of Miller Class I and II isolated gingival~     recessions treated with the modified tunnel approach (mTA) versus the conventional tunnel~     technique (cTT) in conjunction with subepithelial connective tissue graft (SCTG).~      Material and Methods: In this split-mouth study, thirty healthy patients exhibiting two~     isolating anterior Miller Class I and II gingival recessions were treated with mTA + SCTG and~     cTT + SCTG. Treatment outcomes were assessed at baseline, 3-months and 6-months~     postoperatively. The primary outcome was root coverage esthetic scores (RES).~   "
70599|NCT02642874|"~     Muscle cramps markedly affect the quality of life in cirrhotic patients with no highly~     effective drug. Methocarbamol is a central muscle relaxant used to treat skeletal muscle~     spasms. The mechanism of action of methocarbamol is currently unknown, but may involve the~     inhibition of carbonic anhydrase. Methocarbamol has a high therapeutic index, i.e. a wide~     range of safe and effective dosages.~   "
70600|NCT02642861|"~     - Cyclobenzaprine, is a muscle relaxer medication used to relieve skeletal muscle spasms. It~     is one of the best-studied drug for this application.~   "
70601|NCT02642848|"~     The purpose of this research is to confirm the efficacy of cartilage regeneration (or stem~     cell transplant) simultaneously performed with high tibial osteotomy. Furthermore, as~     conventional microfracture surgery on injured cartilage has a disadvantage of the replacement~     by fibrocartilage, this research intends to prove the excellence over the conventional~     therapy by proving a hyaline cartilage regeneration of injured cartilage by stem cell.~   "
70602|NCT02642835|"~     Prolapse of the vaginal wall and uterus are common conditions affecting up to 50% of parous~     women. The socioeconomic, psychological and physical impacts of prolapse are considerable.~     11% of women will undergo a surgical repair by the age of 80 years. The commonest compartment~     affected is the anterior vaginal wall. Unfortunately there is a significant rate of recurrent~     prolapse or a failure of the primary procedure. This has lead to the introduction of new~     techniques and the use of different materials to augment the repair. Mesh augmented repairs~     aim to reduce the rate of recurrent prolapse. However, the use of synthetic mesh is~     associated with complications which are not found in non mesh repairs. 10% of women will have~     a mesh complication of which 70% will require a further surgical procedure to manage the~     complication. There are extra costs associated with purchasing the mesh, with longer~     operating times to insert the mesh and managing complications caused by the mesh. Balancing~     the extra risks of mesh surgery against the benefits is probably one of the most contentious~     issues in urogynaecology at the present time.~      Regulatory authorities in the USA (FDA) and UK (MHRA) have become increasingly interested in~     the use of mesh to support the vaginal wall in prolapse surgery due to risks and~     complications being reported. To date there is little evidence regarding the long term safety~     and efficacy of anterior mesh repairs. This study aims to rectify this deficiency for~     Perigee.~   "
70603|NCT02642822|"~     In this study, 100 female students aged 18 to 30 years old in Xiamen University will be~     enrolled. On the first visit, blood, saliva and urine samples of all participants will be~     collected. Then saliva and urine samples will be collected at two-week interval until 6~     months. Serum samples will be tested the PP150-IgG titer. Saliva and urine samples will be~     used to test CMV DNA by PCR. The primary purpose of this study is to identify the~     relationship between baseline PP150-IgG titer and CMV infection.~   "
70604|NCT02642809|"~     The investigators propose to treat patients with metastatic esophageal cancers and dysphagia~     with two fractions of brachytherapy followed by pembrolizumab. The brachytherapy is~     hypofractionated and will provide a radiation dose of sufficient intensity to induce the~     release of tumor-derived antigens and trigger an antitumor immune response. The simplicity of~     the design should maximize the chance to examine the hypothesis that radiotherapy can induce~     an immune response, which can then be augmented by pembrolizumab treatment. Success in this~     study would provide the impetus to conduct further trials aimed at developing this unique~     strategy as a more broadly applicable therapeutic option in the treatment of patients~     suffering from these deadly cancers, and will provide important mechanistic insights into the~     relationship between radiation treatment and immune therapy augmentation.~      Taken together, these data indicate that targeting the PD-1/PD-L1 axis in esophageal cancers~     in combination with radiation therapy may be a rational treatment strategy for these cancers.~   "
70605|NCT02642796|"~     Aim of the study to assess the efficacy of two modes of transcutaneous electrical nerve~     stimulation (TENS) on relief of postoperative acute pain after hip fracture surgery.~   "
70618|NCT02642627|"~     This is an open-label, multicenter, prospective pilot study assessing the efficacy and safety~     of Bellafill for correction of distensible atrophic acne scars in the full facial area. All~     enrolled subjects will receive initial treatment with Bellafill, as well as touch-up~     treatments (if necessary to achieve optimal correction). Subjects will be evaluated at~     Screening (Month -1), Day 0 (Baseline) Month 1, Month 4, and Month 7.~   "
70606|NCT02642783|"~     Samples of 4 commercially available bowel cleansing solutions, namely PEG-electrolyte +~     ascorbic acid (PEG-Asc, Moviprep®, Norgine, UK), PEG-electrolyte (PEG, Fortrans® Ibsen,~     France), sodium picosulfate/magnesium citrate (SPS, Picoprep®, Ferring, Switzerland), and~     oral sodium sulfate (OSS, Izinova®, Ibsen, France) were prepared according to the~     manufacturer's instructions. Descriptive analysis was conducted with trained panelists (N=~     14) to create a sensory profile for the solutions and generated attributes were rated on an~     unstructured 15-cm line scale using the Compusense at-hand® (Guelph, Canada) sensory~     evaluation software. Acceptability testing was carried out with untrained participants (N=80)~     and samples were rated on the 9-point hedonic scale. Moreover, a Just-About-Right (JAR) scale~     was included for the four basic tastes to determine their compatibility with optimum~     taste/acceptability levels in the products.~   "
70607|NCT02642770|"~     Patients presenting with Left Ventricle (LV) dysfunction undergoing cardiac surgery are at~     increased risk of perioperative morbidity and mortality. LV dysfunction has been reported as~     an independent predictor of operative mortality in patients undergoing Cardiac surgery. It~     also often leads to low cardiac output states with many of these patients requiring inotropic~     or mechanical support and vasopressors for hours to days after surgery. Speckle tracking when~     combined with three dimensional (3D) imaging techniques might prove to be a more sensitive~     marker for ventricular dysfunction. The present study investigates early outcomes in a~     consecutive series of patients with LV dysfunction undergoing cardiac surgery~   "
70608|NCT02642757|"~     This study evaluates the effectiveness of a brief intervention for the reduction of alcohol~     use among risky alcohol users in primary care delivered by paramedics. Half of the~     participants will receive a brief intervention and half will receive written guidelines on~     safe alcohol use.~   "
70609|NCT02642744|"~     This study will examine if the attending nurse model will enhance critical patient-centered~     elements of care that will in turn improve patient education and shared decision-making,~     medication adherence, stroke-related health literacy, and reduce early readmissions to~     ultimately yield improved patient quality of life. Our primary objective is to determine~     whether the attending nurse model of care improves stroke patients' health at 7 days, 30~     days, and 90 days after hospital discharge as assessed through questionnaires.~   "
70610|NCT02642731|"~     Sensitive renal markers have been studied abundantly in connection with open heart, liver and~     transplantation surgery; however in major orthopaedic surgery their use is anecdotal. The aim~     of the present study is to evaluate use of sensitive renal markers, NGAL (Neutrophil~     gelatinase associated lipocalin ), KIM-1 (Kidney injury molecule- 1), LFABP (liver-type fatty~     acid-binding protein), and IL-18 (interleukin -18), in patients coming for elective TKA~     (total knee arthroplasty) as a pilot study before large study concerning acute kidney injury~     in orthopaedic surgery.~   "
70611|NCT02642718|"~     Background: Experimental models using short duration noxious stimuli have led to the concept~     of pre-emptive analgesia. Ketorolac, a non-steroidal anti-inflammatory drug (NSAID), has been~     shown to have a post-operative narcotic sparing effect when given pre-operatively and~     alternatively to not have this effect. This study was undertaken to determine whether a~     single intravenous dose of ketorolac would result in decreased post-operative pain and~     narcotic requirements.~      Methods: In a double-blind, randomized controlled trial, 48 women undergoing abdominal~     hysterectomy were studied. Patients in the ketorolac group received 30 mg of intravenous~     ketorolac 30 minutes before surgical incision, while the control group received normal~     saline. The post-operative analgesia was performed with a continuous infusion of tramadol at~     12 mg/hour with the possibility of a 10 mg bolus every 10 minutes. Pain was assessed using~     the Visual Analog Scale (VAS), tramadol consumption and hemodynamic parameters at 0, 1, 2, 4,~     8, 12, 16 and 24 hours post-operatively. We quantified times to rescue analgesic (morphine),~     adverse effects and patient satisfaction.~   "
70612|NCT02642705|"~     The present study aims at evaluating the effect of two innovative treatment strategies in~     obese patients: high intensity interval training and hypoxic conditioning. Obese patients~     will be randomized in groups performing high intensity interval training, constant load~     training, hypoxic conditioning or placebo normoxic conditioning for 8 weeks. The effects of~     the interventions will be measured regarding exercise tolerance, blood pressure, body~     composition, metabolic status.~   "
70613|NCT02642692|"~     The purpose of this study is to specifically evaluate outcomes of bone-patellar tendon-bone~     autograft versus hamstring autograft ACL reconstruction in soccer players.~   "
70614|NCT02642679|"~     The purpose of this single center, prospective case series is to evaluate the effective~     management of split-thickness skin graft donor site wounds using Opticell Ag (Chitosan-based~     dressing).~   "
70615|NCT02642666|"~     This pilot project will evaluate yoga as an intervention to improve attention and reduce~     challenging behaviors such as hyperactivity and impulsivity, rated by parent and teachers, in~     preschool age children with or at risk for attention-deficit hyperactivity disorder (ADHD).~     At Risk for ADHD will be defined as four or more hyperactive/impulsive and/or inattentive~     symptoms on the ADHD Rating Scale IV-Preschool Version as rated by parents or teachers. Using~     a randomized wait-list controlled experimental design, the investigators will explore the~     efficacy of practicing yoga for 6 weeks on behavioral symptoms, attentional control using a~     computer based tasks of attention, and heart rate variability (HRV), which is a measure of~     self-regulatory capacity. The investigators hypothesize that practicing yoga for six weeks of~     will improve ADHD and other behavioral symptoms based on parent and teacher rating scales,~     which will correlate with improvements in scores on the computer based task of attention as~     well as with improvements in HRV.~   "
70616|NCT02642653|"~     The purpose of the study is to test the efficacy of a 20 week multi-modal treatment comprised~     of lovastatin or placebo, and the Parent-implemented Language Intervention (PILI) in children~     with FXS. Children will be randomized to drug or placebo in a double-blind design with all~     participating in the PILI. The primary endpoint will be to measure improvements in spoken~     language and behavior among lovastatin-treated than placebo treated participants.~   "
70617|NCT02642640|"~     This project aims to test the impact of melatonin and MTNR1B variation on regulation glucose~     regulation in a highly controlled in-laboratory setting and ex vivo in pancreatic islets.~   "
70619|NCT02642614|"~     The main objective of the current trial is to investigate safety, tolerability,~     pharmacokinetics and effect on inflammation of oral BI 1026706 administered twice daily for 4~     weeks in patients with COPD.~   "
70624|NCT02642549|"~     Girls for Health (G4H) will promote the economic empowerment, agency, and voice of rural~     adolescent girls by supporting their transition from secondary school to tertiary training in~     midwifery, medicine, nursing and other health careers, and in so doing, will address the~     acute shortage of female health workers in rural Northern Nigeria. G4H will integrate proven~     girls' education strategies with innovative vocational interventions to build 1350 girls'~     career aspirations and academic achievement and will significantly increase the number of~     rural girls entering health training institutions (HTI) in four northern states. The program~     will include: 1) a bridge program offering accelerated academic instruction in science, math~     and English; 2) vocational counseling and practicums at local health facilities; 3) safe~     spaces to enhance critical life skills; 4) four month science immersion courses for girls~     accepted for admission to a health training institution; and 5) HTI capacity building to~     cultivate a rural female-friendly learning environment. G4H will work towards sustainability~     from the start by using existing secondary school and HTI infrastructure, and feeding into~     government rural health worker employment schemes.~      G4H will be evaluated using a rigorous cluster randomized controlled trial design,~     randomizing at the school level to assess its impact on key outcomes of interest that include~     rural girls' secondary school graduation and subsequent HTI enrollment, retention and~     completion, as well as delayed marriage and improved agency and voice. Process monitoring and~     costing analysis will be conducted to support quality implementation and dissemination~     efforts. The design will ensure that high quality evidence is available to guide the field~     regarding the effectiveness and costing of in-school bridge programming in broadening rural~     girls' participation in education and career opportunities in the context of low resource~     settings characterized by low rates of female participation in education and income~     generation.~   "
70625|NCT02642536|"~     The purpose of this study is to find out which of two programs, MH MOVE! or the enhanced~     usual care MOVE! program is most effective in improving participation in and completion of~     MOVE! among Veterans with depression, anxiety, and PTSD. One of the treatments, MH MOVE!~     provides the standard MOVE! weight management program plus a workbook containing education~     for management of depression, anxiety and PTSD symptoms to be used during 10 phone based~     clinician led CBT sessions. The enhanced usual care MOVE! provides the standard MOVE! weight~     management program plus a workbook containing education for management of depression, anxiety~     and PTSD symptoms but not phone calls are provided.~   "
70626|NCT02642523|"~     The investigators are examining:~        1. the relationships of insulin levels and natriuretic peptide hormone levels, and~        2. the effects of administering an infusion of natriuretic peptide hormone on the breakdown~          of fat~      in healthy lean and otherwise healthy obese individuals.~   "
70627|NCT02642510|"~     The purpose of this study is to evaluate the impact of a structured, DVD educational~     intervention about what to expect during inpatient treatment of a newly diagnosed cancer. The~     focus of the study will be newly diagnosed lymphoma and acute leukemia patients and their~     family members. Outcome variables will be the patient and family member's satisfaction with~     inpatient teaching and anxiety about inpatient treatment.~   "
70628|NCT02642497|"~     This study aims at exploring the analgesic efficacy, and safety of Ketamine instillation into~     the wound of total thyroidectomy compared to placebo,and to systemic ketamine administration~     (I.M. injection of the same dose) with respect to postoperative VAS, first request of~     analgesia, total opioid consumption, and with respect to possible side effects.~   "
70629|NCT02642484|"~     -  Muscle cramps markedly affect the quality of life in cirrhotic patients with no highly~          effective drug.~        -  Quinine was suggested for treatment of patients with muscle cramps in patients with~          liver cirrhosis. However, thrombocytopenia, cardiac arrhythmias and cinchonism are~          serious side effects.~   "
70630|NCT02642471|"~     The diagnostic value of sentinel lymph node biopsy in early-stage cervical cancer has been~     well studied. However, there were no randomized controlled study on comparing the long-term~     outcomes of sentinel lymph node biopsy and conventional procedure. The investigators perform~     a phase III, randomized controlled trial to determine whether pelvic lymphadenectomy could be~     replaced by sentinel lymph node biopsy in surgical treatment for patients with early-stage~     cervical cancer.~   "
70631|NCT02642458|"~     Despite the clear benefit of a combination therapy of pertuzumab plus trastuzumab plus~     docetaxel when compared with a combination therapy of trastuzumab and docetaxel the study~     populations of the CLEOPATRA trial might be slightly different from a patient population, in~     which pertuzumab, plus trastuzumab plus chemotherapy or trastuzumab plus chemotherapy are~     applied in routine clinical practice.~      This non-interventional approach aims to confirm the clinically relevant outcomes shown in~     the phase III CLEOPATRA study in patients with advanced HER2-positive breast cancer in~     routine practice. Docetaxel is recommended as chemotherapy, however, any treatment choice or~     change in regimen is performed at the discretion of the treating physician.~      Data on efficacy, safety, tolerability and quality of life will be documented for this~     purpose. Following the recommendations as laid down in guidelines for treatment of breast~     cancer, the quality of life of patients will be assessed on a regular basis.~   "
70632|NCT02642445|"~     Renal sympathetic denervation from the intima of renal arteries has become an important~     method for the treatment of resistant hypertension, but renal sympathetic nerve are mainly~     located in the adventitia, and there is no report about renal sympathetic denervation from~     the renal adventitia. Primary aldosteronism is an important factor of secondary hypertension,~     tumor aldosterone in unilateral adrenal can increase the concentration of plasma aldosterone,~     in some patients blood pressure control is still not desirable after resection of tumor~     aldosterone. This study intends to conduct renal sympathetic denervation ablation from the~     adventitia to observe its efficacy and safety on blood pressure of patients with primary~     aldosterone.~   "
70633|NCT02642432|"~     The purpose of this study is to assess the safety and efficacy of ABT-493/ABT-530 following~     12 weeks of treatment in adults with chronic Hepatitis C Virus Infection genotype 1, 2, 4, 5~     or 6 infection and compensated cirrhosis.~   "
70647|NCT02642250|"~     Revival of significance and the emergent market of herbal medicinal products necessitate~     strong commitment by the stakeholders to safeguard the end users. The variability in the~     concentrations of constituents of plant material, coupled with the variety of extraction~     techniques and processing steps used by different manufacturers, results in distinct~     inconsistency in the quality of herbal products. The present study will be directed to a~     polyherbal formulation Entoban which integrates an outstanding blend of herbs that have been~     used for decades to eradicate microorganisms and worms from gastrointestinal tract. It is the~     combination of Holarrhena antidysenterica, Berberis aristata, Symplocos racemosa, Querecus~     infectoria and Helicteres isora. The current study would target the chemical assessment,~     pharmacological and comparative clinical evaluation of Entoban to assure its safety and~     efficacy.~   "
70634|NCT02642419|"~     In patients with atrial fibrillation (AF) complicated with coronary artery disease (CAD),~     antiplatelet drugs are commonly used for the prevention of recurrence of stent thrombosis and~     cardiovascular events in combination with anticoagulant drugs. Based on the observations that~     the incidence of hemorrhagic complications increased when an antiplatelet drug was~     administered in combination with vitamin K antagonist (VKA), the guidelines for~     antithrombotic therapy after PCI in the US and EU recommend that DAPT (dual anti-platelets~     therapy) should be used in AF-complicated CAD patients for as short a time as possible~     following single anti-platelet and VKA, and that monotherapy with VKA should be started from~     one year after PCI. In 2013 the European Heart Rhythm Association (EHRA) published the~     guidelines for the use of NOACs in NVAF patients, which state that NOACs may have advantage~     to VKAs in terms of anti-thrombotic effects in NVAF patients undergoing PCI. However, no~     clinical evidence has ever been generated to reveal the efficacy and safety of mono-drug~     therapy with a NOACs in stable CAD patients one year or more after PCI.~      AFIRE study is planned to evaluate the efficacy and safety of mono-drug therapy with a~     rivaroxaban in stable CAD patients. Among NOACs, rivaroxaban was chosen because of the~     evidence in Japanese patients and the results of a sub-analysis of ROCKET AF suggesting that~     rivaroxaban is more effective than VKA in reducing the incidence of myocardial infarction~     (MI).~   "
70635|NCT02642406|"~     Despite treatment improvements in breast cancer, a large number of patients still progress to~     the metastatic stage. Metastatic breast cancer patients have an extremely unfavorable~     prognosis. Not only efficacy, but also quality of life are in the focus when planning a~     therapy or therapy sequence for metastatic breast cancer patients. Therapy options include~     anti-hormonal Therapy, antibody therapies, other targeted therapies and chemotherapies. One~     of the most effective chemotherapies in the adjuadjuvant and metastatic setting is~     paclitaxel. However drug handling and its side effects can compromise patients quality of~     life and can have an impact on the pharmacokinetics of the drug.~      In metastatic breast cancer patients increasing therapy efficacy and reduction of side effect~     frequency are considered to be advancements of therapy. One of these advancements is the~     development of a cremophor free and albumin bound paclitaxel, nab-Paclitaxel (Abraxane),~     which is thought to have a better efficacy and reduced toxicity profile. Nab-Paclitaxel is~     approved for the treatment of metastatic breast cancer after a failure of first-line therapy~     and when antracyclines are not indicated.~      The SERAPHINA study aims to investigate in the use of nab-Paclitaxel in daily routine and the~     frequency and perception of side effects.~      As a non-interventional study, the SERAPHINA Study will assess the patient characteristics~     and describe the patient cohort, in which nab-Paclitaxel is given. This includes age~     distribution, molecular epidemiological characteristics and characteristics documented by the~     patients themselves.~   "
70636|NCT02642393|"~     A multicenter, randomized, double-blind, placebo-controlled, phase 3 trial to determine~     whether oral inosine dosed to moderately elevate serum urate (from ≤5.7 mg/dL to 7.1-8.0~     mg/dL) over 2 years slows clinical decline in early PD.~      Clinical decline will be assessed as change in the primary outcome variable of the Movement~     Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), a composite scale~     comprising patient- and clinician-reported outcomes.~   "
70637|NCT02642380|"~     The project was organized by Qilu Hospital of Shandong University in China. In order to~     report the efficacy and safety of different cycles of high-dose dexamethasone for the~     treatment of adults with newly-diagnosed primary immune thrombocytopenia (ITP).~   "
70638|NCT02642367|"~     The routine use of a styletted endotracheal tube during videolaryngoscopy is advocated by~     some manufacturers, but styletted endotracheal tube can elicit rare but potentially serious~     complications. We compared the intubation time and success rate whether or not use of stylet~     for endotracheal intubation with McGrath videolaryngoscope.~   "
70639|NCT02642354|"~     This study will investigate performance criteria over one week of daily wear to determine if~     the Study Test contact lens performs equivalently to the comfilcon A contact lenses in terms~     of measurement and subjective ratings of visual performance.~   "
70640|NCT02642341|"~     This study will investigate performance criteria over one week of daily wear to determine if~     the Study Test contact lens performs equivalently to the comfilcon A contact lenses in terms~     of measurement and subjective ratings of visual performance.~   "
70641|NCT02642328|"~     Traditionally, strength training and power is the main objective of providing only muscle~     conditioning, without possible gains on the VO2Max, however, not for aerobic performance.~   "
70642|NCT02642315|"~     Restless Legs Syndrome (RLS) is a common neurological disorder. Augmentation is the main~     complication during long-term DA treatment of RLS. This study aims to examine effect of~     Horizant (Gabapentin Enacarbil) on Augmentation in RLS patients.~   "
70643|NCT02642302|"~     Based on studies of high intensity interval training (HIIT) in the literature, higher gains~     in VO2max and performance are obtained in short periods of training time. However, different~     designs training configurations, for example, changing the time interval, could influence~     such gains on VO2max and aerobic performance. The aim of the study was to observe the~     possible influences of diferetes types of rest intervals in high intensity interval exercise~     protocol on VO2max, and the aerobic and anaerobic performances in 12 weeks of training.~   "
70644|NCT02642289|"~     This study evaluates the benefits of probiotics in patients with fibromyalgia syndrome.~   "
70645|NCT02642276|"~     In this controlled trial, patients with peripheral arterial disease will be randomized to~     either maximal walking, submaximal walking, or usual care groups.~   "
70646|NCT02642263|"~     Carbetocin is an oxytocin agonist used for prevention of postpartum bleeding after cesarean~     delivery. First studies revealed in 2012 an analgesic effect of carbetocin, compared to its~     parent substance oxytocin. This study will enroll 78 women undergoing cesarean delivery. In a~     double-blind, prospective design patients will be either attributed to the oxytocin or the~     carbetocin study arm. The primary endpoint will be the area of hyperalgesia around the~     cesarean delivery scar. This will be performed with a von Frey hair, resulting in a~     unpleasant feeling in the area of hyperalgesia.~   "
70648|NCT02642237|"~     To evaluate the bacterial-viral interactions between LPS and Fluenz as a model for sepsis~     (bacterial) and Influenza (viral) infections which are common and associated with high~     mortality rates in the ICU. To understand these interactions is important for the development~     of preventive and therapeutic interventions.~   "
70651|NCT02642198|"~     This study is being conducted to validate the accuracy of non-invasive blood pressure (NIBP)~     measurement technology from Mortara Instrument, Inc. (Milwaukee, Wisconsin, USA) and Zoe~     Medical, Inc. (Topsfield, Massachusetts, USA) in a neonatal, infants and children up to 3~     years old patient population. The study is defined according to the International Standard~     ANSI/AAMI/ISO 81060-2:2013, Non-invasive sphygmomanometers — Part 2: Clinical investigation~     of automated measurement type.~   "
70652|NCT02642185|"~     This study aims to prove that a strategy of first line local ablation of colorectal liver~     metastases with microwaves is not inferior to liver resections in terms of survival rates at~     three years with secondary endpoints being survival at five and ten years, interventional~     complication rates, length of stay, ablation precision measurements, need for further~     interventions and health-economic analysis.~      A cohort of 100 patients treated with CT guided microwave ablation of 1-5 metastases <31mm in~     size will be followed and compared with propensity scored matched controls from the Swedish~     liver surgery registry - Sweliv.~      The study is a multi-institutional effort by the Hepato Pancreatico Biliary (HPB) units in~     Stockholm Sweden, Bern Switzerland and Groningen in the Netherlands.~   "
70653|NCT02642172|"~     The purpose of this present study is to evaluating whether prebiotics - ITF (Inulin/OFS~     75/25) is effective in treating patients with non-alcoholic liver disease.~   "
70654|NCT02642159|"~     Primary Objective:~      To demonstrate the superiority of alirocumab in comparison with usual care in the reduction~     of non-high-density lipoprotein cholesterol (non-HDL-C) in participants with type 2 diabetes~     and mixed dyslipidemia at high cardiovascular risk with non-HDL-C not adequately controlled~     with maximally tolerated statin therapy.~      Secondary Objectives:~        -  To demonstrate whether alirocumab is superior in comparison with usual care in its~          effects on other lipid parameters (ie, low-density lipoprotein cholesterol (LDL-C),~          apolipoprotein B (Apo B), total cholesterol (Total -C), lipoprotein a (Lp[a]),~          high-density lipoprotein cholesterol (HDL-C), triglycerides (TGs), triglyceride rich~          lipoproteins (TGRLs), apolipoprotein A-1 (Apo A-1), apolipoprotein C-III (Apo C-III),~          lipid subfractions by nuclear magnetic resonance (NMR) spectroscopy (ie, LDL-C particle~          size and LDL, very low-density lipoprotein [VLDL], HDL, and intermediate-density~          lipoprotein [IDL] particle number).~        -  To assess changes in glycemic parameters with alirocumab vs. usual care treatment.~        -  To demonstrate the safety and tolerability of alirocumab.~        -  To evaluate treatment acceptance of alirocumab.~        -  To evaluate proprotein convertase subtilisin kexin type 9 (PCSK9) concentrations and~          antibody development.~        -  To demonstrate the superiority of alirocumab vs. fenofibrate on non-HDL-C and other~          lipid parameters (subgroup analysis).~   "
70655|NCT02642146|"~     This study evaluates the efficacy and safety of routine medical treatments of digital ulcers~     in patients with systemic sclerosis in a prospective cohort study.~   "
70656|NCT02642133|"~     This study is an observational study to determine outcomes of surgical release of tongue-tie~     and lip-tie in babies who are experiencing difficulty with breastfeeding.~   "
70657|NCT02642120|"~     To assess if the use of the dental support device( DSD) Laboraide™ shortens the second stage~     of labor and decreased the rate of obstetrical interventions, and if it's use alleviate pain.~   "
70658|NCT02642107|"~     Currently, most protocols of nasopharyngeal carcinoma(NPC) of various research bodies such as~     the Radiation Therapy Oncology Group require routine elective irradiation to the~     retropharyngeal area and to levels II-V, and also to the supraclavicular lymph nodal areas~     regardless of the status of nodal metastasis. Previous studies had confirmed that the pattern~     of cervical lymph node metastasis in NPC followed an orderly manner. Retropharyngeal lymph~     nodes (RLNs) and Level II LNs were the most commonly involved, followed by Level III and~     Level V LNs, Level IV LNs, and SCF LNs, and the incidence of LN skip metastasis is rare,~     ranging from 0.5% to 7.9%. It was rare for NPC patients without neck lymph node metastases to~     experience neck failure after elective irradiation to levels II, III and VA. It also~     confirmed that with unilateral LN metastases of higher-level LNs usually spread down~     ipsilateral LNs.Thus, the investigators conduct the non-inferior randomized trial to~     determine the value of elective neck irradiation in NPC with N0-N1.~   "
70659|NCT02642094|"~     To examine whether rapamycin can reduce malignant markers and aberrant mammary~     stem/progenitor cells (MaSCs) number in surgical specimens~   "
70660|NCT02642081|"~     The purpose of this study is to evaluate whether non-steroidal anti-inflammatory drugs~     (NSAIDs) were associated with acute kidney injury (AKI) in patients with heart failure. In~     addition, the investigators would like to assess the risk of admission for acute~     decompensated heart failure following exposure to NSAIDs within 30 days.~   "
70661|NCT02642068|"~     We anticipate that drug-naïve ADHD probands, particularly those with DAT1 or SLC6A2 gene~     variants may have higher level of altered microstructural integrity of frontostriatal (FS),~     frontoparietal (FP), other hypothesized fiber tracts and decreased brain activity of FS, FP,~     and other circuits, deficits in ERP, and impaired EF, SA, IIA and VM than probands without~     DAT1 or SLC6A2 gene variants or adult neurotypical. The alterations in the structural and~     functional connectivity, neurophysiological and neuropsychological functioning would be~     observed in the unaffected siblings as compared to neurotypical. The unaffected siblings will~     be in the intermediate position between drug-naïve adult ADHD probands and neurotypical. The~     genetic dosage is anticipated to pose the strongest effects on the cortical thickness, brain~     volume, gyrification and microstructural property of white matter, followed by~     neurophysiology, functional connectivity, and neuropsychological function with the least~     effect.~      In terms of longitudinal follow-up part, we also anticipated despite increasing thinning of~     cortical thickness, microstructural integrity of several targets fiber tracts, and brain~     activity of target brain regions and improving performance in EF, SA, IIV, VM from childhood~     to late adolescence and young adulthood in the neurotypical group, the slopes of~     developmental trajectories of these neuroimaging and neuropsychological function are lower in~     the ADHD group.~   "
70662|NCT02642055|"~     This study evaluates the efficacy of the Neuro+ Attention Training System (Neuro+) in~     improving attention skills in children. Half of participants will receive the Neuro+~     intervention for 10 weeks, while the other half will continue treatment as usual (TAU) for~     the same period. We expect those receiving the Neuro+ intervention to see significant~     improvements in ADHD symptoms relative to the TAU controls.~   "
70663|NCT02642042|"~     This phase II trial studies how well trametinib and docetaxel work in treating patients with~     stage IV KRAS mutation positive non-small cell lung cancer or cancer that has come back.~     Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Giving trametinib with docetaxel may work better in treating~     non-small cell lung cancer.~   "
70664|NCT02642029|"~     The goal of this study is to use transcranial magnetic stimulation (TMS) to investigate the~     impact of modulating cerebellar activity on time perception, executive function, and mood and~     psychotic symptoms in psychosis patients (i.e., schizophrenia, schizoaffective disorder, and~     bipolar disorder with psychotic features) and healthy control participants. The investigators~     hypothesize that abnormally reduced activity in the cerebellum contributes to the~     abnormalities in patients, that cerebellum-mediated disruptions in time perception may~     partially underlie executive dysfunction and symptoms, and that cerebellar stimulation will~     normalize disease-relevant outcome measures.~   "
70665|NCT02642016|"~     This is a dose-escalation Phase 1 study designed to determine the maximum tolerated dose~     (MTD) and/or recommended Phase 2 dose, and the safety profile of CDX-0158 in patients with~     KIT-positive advanced solid malignancies refractory to standard therapy or for which no~     standard therapy exists.~   "
70666|NCT02642003|"~     Background and Aims: Liver transplantation is the only curative treatment modality for~     decompensated cirrhosis and is limited by donor organ availability and financial resources;~     thus many patients die while awaiting liver transplant. Granulocyte colony stimulating factor~     (GCSF) therapy can mobilize bone marrow stem cells for tissue regeneration, and has been~     shown to benefit patients with liver disease. The investigators evaluated the efficacy of~     GCSF therapy in decompensated cirrhosis in an open labelled randomized control trial.~      Patients and Methods: Consecutive patients with decompensated cirrhosis of mixed etiologies~     were randomized to receive either a 5-day course of GCSF (5 μg/kg/d) plus standard medical~     therapy for 6 months (Group-A); or standard medical therapy alone for 6 months (Group-B). At~     the end of 6 months their survival were compared.~   "
70667|NCT02641990|"~     A Phase 1, randomized, double-blind, placebo-controlled, crossover study to assess the effect~     of ITCA 650 on the pharmacokinetics (PK) of once daily administration of Levora® (ethinyl~     estradiol 0.3 mg (EE) and levonorgestrel 0.15 mg (LNG) in healthy premenopausal female~     subjects.~   "
70668|NCT02641977|"~     Longterm followup of patients with rheumatoid arthritis 30 years after starting a baseline~     treatment with Methotrexate.~   "
70669|NCT02641964|"~     Try to collect about 350 cases of acute necrotizing pancreatitis at the First Affiliated~     Hospital with Nanjing Medical University and Nanjing General Hospital of Nanjing Military~     Command. Then the investigators studied the incidence and the risk factors of ARDS in~     patients with acute necrotizing pancreatitis.~   "
70670|NCT02641951|"~     Post mastectomy pain syndrome result from surgical damage to the intercostobrachial nerve,~     the lateral cutaneous branch of the second intercostal nerve that is often resected at~     mastectomy. result from surgical damage to the intercostobrachial nerve, the lateral~     cutaneous branch of the second intercostal nerve that is often resected at mastectomy, A~     second version of the pectoral nerve block is described, called ''modified Pecs block'' or~     Pecs block type II.~      This novel approach aims to block at least the pectoral nerves, the intercostobrachial,~     intercostals III-IV-V-VI and the long thoracic nerve. These nerves need to be blocked to~     provide complete analgesia during breast surgery~   "
70671|NCT02641938|"~     To investigate the renal protective effect of dexmedetomidine in patients undergoing~     cytoreduction and hyperthermic intraperitoneal chemotherapy~   "
70672|NCT02641925|"~     Many features of the metabolic syndrome are associated with insulin resistance. And,~     metabolic syndrome and insulin resistance are related to visceral obesity. Therefore, the~     investigators hypothesized that visceral fat removal (omentectomy) can make favorable results~     for the insulin resistance and metabolic syndrome. As the omentectomy is optional procedure~     during a surgery for early gastric cancer, the investigators will divide patients randomly~     into two groups, total omentectomy group and omentum preserving group.~   "
70673|NCT02641912|"~     This will be a single center, 7-day, examiner blind, two treatment-arm, randomized,~     stratified (Sjogren's Syndrome status [Y/N]), parallel group study conducted in participants~     experiencing dry mouth symptoms. This study is designed to investigate the effect of an~     experimental mouthwash formulation in providing relief of dry mouth symptoms.~   "
70674|NCT02641899|"~     A Phase 1, Fixed-Sequence, Open-label Study in Healthy Subjects to Estimate the Effects of~     ITCA 650 on Gastric Emptying and on the Absorption Pharmacokinetics of Each of 4 Commonly~     Studied DDI Probe Compounds.~   "
70675|NCT02641886|"~     The purpose of this study is to determine whether the chinese medicine Jian Pi Yi Shen Hua~     Tan granules is effective in the treatment of cognitive impairment after acute cerebral~     infarction .~   "
70676|NCT02641873|"~     This is an open-label, multicenter, phase 1 study of BBI608 in combination with FOLFIRI +~     Bavacizumab. This study population is adult Japanese patients with metastatic colorectal~     cancers in FOLFIRI + Bevacizumab combination therapy.~   "
70677|NCT02641860|"~     Evaluate the safety and efficacy of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor~     Cells Therapy for Knee Osteoarthritis.~   "
70678|NCT02641847|"~     The purpose of this study is to compare the efficacy and safety between docetaxel combined~     with doxorubicin (epirubicin) and cyclophosphamide followed by gemcitabine combined with~     cisplatin and doxorubicin (epirubicin) combined with cyclophosphamide followed by docetaxel~     for high risk triple negative breast cancer predicted by the mRNA-lncRNA integrated signature~     and validation the efficacy of the signature.~   "
70679|NCT02641834|"~     The study is a randomized, open, cross-over trial designed to test whether a vegetarian diet~     would benefit the cardiovascular risk profile of the participants, compared with a~     Mediterranean diet.~   "
70680|NCT02641821|"~     This is a multi-center, open-label, observational study. The aim of this study is to evaluate~     the efficacy of Nifedipine GITS on lowering blood pressure in Chinese adults with~     mild-to-moderate hypertension.~   "
97475|NCT02291354|"~     The purpose of this study is to evaluate the synergism of Soluble Dietary Fiber with Fecal~     Microbiota Transplantation in Adult Patients with Slow Transit Constipation.~   "
70681|NCT02641808|"~     Follicular aspiration as well as follicular flushing are standardized techniques and have~     been practiced in polyfollicular IVF (in vitro fertilization) therapy for years.~     Monofollicular IVF therapy is a standard technique as well. IVF can be done in natural cycles~     or with a minimal stimulation with clomifen citrate to achieve a monofollicular response. Our~     study aims to compare follicular aspiration and follicular flushing in monofollicular~     stimulation. First the investigators want to answer the question whether flushing is~     beneficial for the oocyte yield. In case of a positive result the investigators want to~     establish a recommendation about the optimal number of flushings taking into account the~     duration of the procedure and the pain during manipulation.~   "
70682|NCT02641795|"~     A first in man clinical trial to asses the the use of am image guided robotic system to~     safely and effectively create a minimally invasive access tunnel to the middle ear cavity to~     allow access to the round window for cochlear implant electrode insertion.~   "
70683|NCT02641782|"~     Although the five year survival rate of children with high risk neuroblastoma have increased~     over the last three decades from 4 to 44 % (1), neuroblastoma is the second most frequent~     cause for cancer related death in childhood (11 %). Most patients show good initial response~     rates (complete (CR) and partial remission (PR) rate 95 %), but 55 % experience a largely~     treatment-resistant tumor progression.~      Recently, a breakthrough with immunotherapy was reported by US investigators from the~     Children's Oncology Group (2) using the anti-ganglioside D2 (GD2) monoclonal antibody ch14.18~     for tumor cell destruction and granulocyte macrophage-colony stimulating factor (GM-CSF) plus~     interleukin 2 (IL-2) for immunostimulation. This immune therapy resulted in an increase of 20~     % Event free survival (EFS) at 2 year from randomization. However, this was associated with a~     high toxicity rate (pain, capillary leak syndrome).~      The proposed trial compares the Childrens' Oncology Group (COG) standard of care arm~     (anti-GD2 + GM-CSF + IL-2 i.v. + retinoic acid oral) with an experimental arm (anti-GD2 +~     GM-CSF + IL-2 s.c. + retinoic acid oral) designed to reduce toxicity.~      The potential benefit from this trial consists of the confirmation that the American trial~     design is feasible in an independent set of patients with different preceding therapy, at a~     different time point regarding to immune reconstitution after autologous stem cell~     transplantation (ASCT), the feasibility of a newly designed immunotherapy (which is hopefully~     less toxic) and the investigation of immune response parameters. This pilot study is the~     prerequisite for a consecutive randomized clinical trial comparing two immunotherapeutic~     approaches in a larger set of patients.~   "
70684|NCT02641769|"~     This is an open label, single arm, single center investigation to assess the safety and~     efficacy of purified adult autologous bone marrow derived CD34+, CD133+, and mesenchymal stem~     cells injected into the seminiferous tubules and testis, through a 12 week follow-up period.~     The investigators' selected model of research is based on maximizing the efficiency of the~     approach by choosing an autologous pattern which preserves the genetic make-up of an~     individual that is vital in infertility conditions. Additionally the approach involves~     injecting a combination of different but purified cell types which all aid in the retrieval~     of spermatogenesis, and the generation of mature spermatozoa. Expected outcomes of this study~     are defined in general improvements in infertile patients in regards of testicular~     morphology, sexual function, semen quality, development of primary or secondary~     spermatocytes, spermatids, or mature spermatozoa in the testis, seminiferous tubules, or~     semen.~   "
70685|NCT02641756|"~     The main goal of this study is to identify and characterise the anatomical component of the~     replication competent HIV-1 (Human Immunodeficiency Virus-1) reservoir.~      The investigators hypothesize that the clinically relevant HIV-1 reservoir is hiding in~     various but specific anatomic compartments and is able to rebound when therapy is stopped.~      This reservoir is probably smaller than the HIV-1 reservoir hiding in the blood but could be~     more transcriptional active because of its specific environment, possibly influenced by lower~     concentrations of the antiretroviral therapy.~      The current proposal will, for the first time, identify the source of the viral reservoir by~     phylogenetically backtracking the viral genome of the rebounding virus to the sequences of~     viral DNA (DeoxyriboNucleic Acid) in different anatomical compartments. The subsequent~     characterization of the viral reservoir markers (size, integration sites, methylation~     profile, stimulation and inhibition assays) will enable us to understand how this viral~     rebound occurred.~   "
70686|NCT02641743|"~     A carbohydrate adjusted liquid formula (Inslow) using palatinose as the major carbohydrate~     (>50%) was devised. Consumption Inslow for a long term (3-5 months) is reported to improve~     glycemic control by reducing the postprandial plasma glucose levels in diabetes and impaired~     glucose-tolerant subjects (IGT). The present study intends to understand the mechanism on~     postprandial glycemic responses.~   "
70687|NCT02641730|"~     The purpose of this study is to evaluate the efficacy and safety of guselkumab for the~     treatment of participants with palmoplantar pustulosis.~   "
70688|NCT02641717|"~     Purpose/Objectives: To compare wet mount findings for clue cells, yeast, trichomonads and~     white blood cells per high-power field in self-collected vaginal specimens, compared to~     clinician-collected specimens, among symptomatic women visiting the San Antonio Metropolitan~     Health sexually transmitted disease clinic.~      Research Design/Plan: Prospective, non-randomized, non-blinded trial~      Methods: Obtain informed consent and specimens from 40 symptomatic adult females (eg abnormal~     discharge, odor and/or itching). Calculate concordance between clinician- and~     patient-collected samples using a Wilcoxon Matched-Pair test. Calculate sensitivity,~     specificity, positive predictive value and negative predictive value of the patient-collected~     wet mount, using the clinician-collected specimens as the gold standard.~      Clinical Relevance: A wet mount, or microscopic examination, is commonly used to diagnose~     trichomoniasis and yeast in females, and constitutes one diagnostic element for bacterial~     vaginosis. While patient-collected vaginal swabs are acceptable for nucleic acid probe tests~     for chlamydia and gonorrhea and nucleic acid probe tests for trichomoniasis little~     information about patient-collected wet mounts exists in the literature. Self-collection by~     women before being seen by a clinician can increase the speed and efficiency of the visit.~     The method is highly acceptable to women. In the investigators' clinic, women routinely~     collect their own gonorrhea and chlamydia swabs, so adding an additional swab would not be~     burdensome.~   "
73960|NCT02598791|"~     With the present study, the investigators aim to delineate the effects of GIP/GLP-1 receptor~     co-activity on food intake, appetite, bone health and fat metabolism in overweight/obese~     subjects.~   "
70689|NCT02641704|"~     The aim of this project is a research-based evaluation of a multidisciplinary program~     focusing on moving citizens from unemployment and social security benefits to employment and~     education in Sonderborg Municipality. The citizens who are assigned cannot readily enter the~     labor market or can get education through employment initiatives in the Job Centre in~     Sonderborg Municipality because of complex health-related troubles.~      The project is designed to include a prospective observational study and a qualitative study~     using questionnaires, observations, interviews and informations about employment from the~     Sonderborg Municipality.~   "
70690|NCT02641691|"~     The purpose of this research study is to look at how tumors responds to a short course of~     radiation (5 days) followed by 6 cycles of chemotherapy.~   "
70691|NCT02641678|"~     Prospective mono-center diagnostic study determining potential discrepancies in identifying~     atrial fibrillation by intraindividually comparing different types of follow-up strategies:~        1. How many stroke patients with atrial fibrillation are missed by standard stroke unit~          24h- electrocardiography, and~        2. what is the effectiveness of the extended invasive and non-invasive ECG analysis tools~          to detect atrial fibrillation in stroke patients?~   "
70692|NCT02641665|"~     The level of four biomarkers will be measured in the patients' plasma after induction of~     anaesthesia. There biomarkers are NT-ProBNP, ST2, Galectin-3 and GDF-15. The level of these~     marker will then be correlated with early (30 days) and late (one year) patients' prognosis~     and with functional recovery (MLHFQ score).~   "
70693|NCT02641652|"~     There is currently no established treatment for paroxysmal hypertension, but selective~     serotonin reuptake inhibitors showed good effect in previous reports. This double-blind,~     placebo controlled, prospective multicenter clinical trial will assess the efficacy of~     sertraline on cessation or reduction of symptoms of paroxysmal arterial hypertension. 136~     patients with documented hypertensive paroxysms with abrupt elevations of blood pressure and~     distressful physical symptoms will be randomized in a 1:1 ratio to receive sertraline, 50 mg~     daily, or matching placebo as an add-on to their chronic medication. Effect of the treatment~     on patient symptoms, office and ambulatory blood pressure and side effects will be evaluated~     after 3 months. If proven effective, sertraline might become a standard treatment for this~     condition.~   "
70694|NCT02641639|"~     This is a multicenter, multinational, randomized, double-blind, 2-arm, parallel-group, Phase~     2/3 study to evaluate the efficacy and safety of PCC plus bevacizumab and CA4P versus PCC~     plus bevacizumab and placebo in subjects with platinum-resistant ovarian cancers (prOC).~     Subjects with platinum-resistant, recurrent, epithelial ovarian, primary peritoneal or~     fallopian tube cancer will be randomized 1:1 to receive PCC plus bevacizumab and CA4P or PCC~     plus bevacizumab and placebo. Subjects will be stratified by selected chemotherapy (PLD vs.~     paclitaxel), platinum free interval (< 3 vs. 3 to 6 months from last platinum therapy to~     subsequent progression), and line of therapy (2nd vs. 3rd). This is a 2-part study,~     consisting of a Phase 2, exploratory study (Part 1) followed by a Phase 3, pivotal study~     (Part 2). Both parts of the study will have similar overall design. Approximately 80 subjects~     will be randomized into Part 1 and approximately 356 subjects will be randomized into Part 2.~   "
70695|NCT02641626|"~     Prospective, multicenter, randomized clinical trial. Survivors from an out-of-hospital~     cardiac arrest (OHCA) without ST segment elevation in their EKG will be recruited.~     Potentially non-cardiac etiology of the cardiac arrest will be ruled out prior to~     randomization. Primary goal (treatment): to evaluate the efficacy of urgent vs deferred~     coronary angiography in survivors from OHCA without ST-segment elevation in the EKG.~   "
70696|NCT02641613|"~     Patients will be randomized to one of two groups:~        1. Supraclavicular group: supraclavicular brachial plexus block performed with the aid of~          ultrasound;~        2. Retroclavicular group: retroclavicular brachial plexus block performed with the aid of~          ultrasound.~   "
70697|NCT02641600|"~     Patients with chronic venous disease causing pain or ache will be randomised into two groups,~     active stockings (18-21 mmHg) or placebo stockings~   "
70698|NCT02641587|"~     The overall goal of the study is to demonstrate reduction in the levels of biomarkers of~     exposure (BoExp) to selected harmful and potentially harmful constituents (HPHCs) and to~     obtain safety information in healthy subjects using the Carbon Heated Tobacco Product 1.2~     (CHTP 1.2) as compared to smokers continuing smoking combustible cigarettes (CC) in a~     confinement setting for 5 days (exclusive use) followed by an ambulatory setting of 85 days.~   "
70699|NCT02641574|"~     To examine the relation between complication in Repeated Cesarean Sections and Newborn~     Outcome compared to number of repeated cesarean section and reasonf or surgery and personal~     medical information to the mother~   "
70700|NCT02641561|"~     Post-ERCP pancreatitis is a well-known and sometimes life-threatening complication of ERCP.~     Both LR and rectal indomethacin have shown benefit in preventing post-ERCP pancreatitis.~     Despite this, no study to date has evaluated both of these measures for preventing post-ERCP~     pancreatitis. It is our hope to evaluate the combination of these two modalities for~     preventing post-ERCP pancreatitis compared with either modality alone.~   "
70701|NCT02641548|"~     This study evaluates the addition of using a sock of silicone to using a heel cream, in the~     treatment of heel fissures in people with diabetes, aiming at healing the fissures and~     preventing them from developing into ulcers. Half of the participants will use the silicone~     sock and a heel cream, the other half will use the cream only.~   "
70702|NCT02641535|"~     Israel ministry of defense is examining a new BC membrane protective garment of BLAUER~     company constructed with GORE CHEMPAK fabric for the border guard of the police forces. The~     goal of this research is to perform a comparative experiment in order to evaluate the~     physiological strain induced by the new protective garment under exercise-heat stress~     conditions, compared to protective garment in current use.~   "
70703|NCT02641522|"~     The purpose of this study is to evaluate the effects of siltuximab on immune cell functions~     in patients with Type 1 diabetes (T1D).~   "
70757|NCT02640820|"~     Warts are benign epidermal tumors caused by human papillomaviruses (HPVs). The active~     pharmaceutical ingredient DPCP has been used for many years as a compounded formulation in~     acetone for the treatment of warts, alopecia areata and more recently, cutaneous metastatic~     melanoma lesions. An improved topical ointment formulation of DPCP called Samcyprone™ will be~     evaluated for the treatment of common warts.~   "
70704|NCT02641509|"~     Interval colon cancers are an important clinical issue. Literature dealing with technics and~     quality of polypectomy is scarce. A recent paper from Pohl et al focused on non-pedunculated~     polyps of 5-20 mm, evaluating non complete polypectomy and factors related to it, revealing~     that 10% of these polyps were not completely resected. This fact was attributed to size and~     histology (the majority of non completely resected ones, were polyps of 10-20 mm and with~     serrated characteristics at the histology). In this study the investigators want to evaluate~     the radical resection of non-pedunculated polyps of 5-20 mm by performing biopsies on the~     margins immediately after polypectomy, to establish if the use of Narrow Band Imaging (NBI)~     could be useful in the definition of the margins of the lesion before polypectomy.~   "
70705|NCT02641496|"~     Approximately 20 million Americans suffer from Obstructive Sleep Apnea (OSA) creating risks~     for major health problems, including dementia, heart attack, and stroke. Obesity, a growing~     problem for Americans and Veterans alike, is the greatest risk factor for the development of~     OSA. Male gender and smoking, other OSA risk factors, are common in Veterans. Given the high~     comorbidity of these risk factors in Veterans, OSA presents a significant health burden to~     Veterans. The investigators' prior work provides evidence that OSA occurs in up to 69% of~     Vietnam-era Veterans with PTSD. OSA is easily treated; however, 15-30% of OSA patients are~     non-compliant with continuous positive airway pressure (CPAP), the standard OSA treatment.~     The proposed research aims to facilitate adherence to CPAP treatment by testing a novel~     cognitive-behavioral therapy intervention in Veterans with PTSD. If successful, it may~     represent an approach that could be applied to the rehabilitation of other chronic conditions~     with similar barriers to care.~   "
70706|NCT02641483|"~     The investigators are testing the effect of electrical stimulation of the rectum on colonic~     motility. Most individuals with spinal cord injury develop neurogenic bowel dysfunction,~     which includes slowed colonic motility, which means that stools take longer than normal to~     pass through the colon. This slowed movement may result in chronic constipation and~     difficulty emptying the bowels. Individuals typically (without or without caregiver~     assistance) insert a gloved finger into the rectum and gently stretch it to improve colonic~     motility for a brief period to empty the bowels. The investigators hypothesize that~     electrically stimulating the rectum, instead of mechanically stretching it, will produce the~     same beneficial effect of improving colonic motility. Therefore, this study will compare the~     two methods. If electrical stimulation effectively improves colonic motility, then the~     investigator shall develop the approach as a therapeutic intervention in future studies.~   "
70707|NCT02641470|"~     Asthenopia or eye strain describes nonspecific symptoms of an eye when it is tired from~     intensive work. Vaccinium uliginosum is a flowering plant in the genus Vaccinium. This plant~     is native to cool temperature regions of the Northern Hemisphere. Considering its~     antioxidative ingredients, the extract of Vaccinium uliginosum is expected to play a~     significant role in treating various ocular pathologies. The investigators performed a~     randomized, case-controlled study in healthy subjects and investigated the protective effect~     of Vaccinium uliginosum extract (DA-9301) on tablet computer-induced asthenopia.~   "
70708|NCT02641457|"~     Aflibercept (Eylea®) and ranibizumab (Lucentis®) are an anti-VEGF, but there are differences~     between the two drugs. To determine and compare whether intraocular aflibercept and~     ranibizumab decreases rubeosis iridis (RI) in patients with neovascular glaucoma (NVG).~   "
70709|NCT02641444|"~     The purpose of this research study is to find out how the drugs Truvada®~     (tenofovir/emtricitabine), Isentress® (raltegravir), Reyataz® (atazanavir), Sustiva®~     (efavirenz), and Selzentry® (maraviroc) get into the intestines and the female genital tract.~     All of these drugs are very effective at reducing the number of HIV viruses in the blood,~     however it is unknown how the drugs move around inside tissues where HIV might be hiding.~     This study will determine specifically where in the tissue the drug and the HIV are located~     through the use of a new technology that takes creates a picture of the tissue. This~     information will help scientists determine the best way to make new drugs to target the~     hidden HIV in tissue.~   "
70710|NCT02641431|"~     This prospective study evaluates the methodology and results of epicardial mapping/ablation~     in a large series of consecutive selected BrS patients and to verify if RFA could normalize~     the consequences of a genetic disease.~   "
70711|NCT02641418|"~     Background: Peripheral arterial disease is a result of atherosclerotic occlusion in the major~     arteries supplying the lower limbs and is associated with an increased risk of mortality and~     morbidity. It results in restricted blood flow to the skeletal muscles causing intermittent~     claudication (IC). IC presents as cramp like pain affecting 5% of the population >50 years~     and is associated with a substantial reduction in walking capacity, quality of life and~     diminished physical function. Supervised exercise programmes have been demonstrated to~     improve maximum walking distances and NICE recommends group-based supervised exercise for~     treating patients with IC. However, there is significant variability in the impact of~     treatment across studies and little agreement on the underlying mechanism whereby exercise~     increases functional outcomes. Potential mechanisms include skeletal muscle metabolism, VO2~     max, anaerobic threshold and endothelial function. Studies are needed to better understand~     how exercise improves outcome and in whom, so as to better refine and target the treatment.~      The participation of patients with IC in exercise programmes is low. The investigators need~     to understand factors influencing participation so that we can improve the number of patients~     with IC benefiting from the programme~      The research consists of two workstreams:~      Workstream one~      Objective:~      Assess the extent to which patient baseline characteristics and candidate physiological~     mechanisms are associated with clinical improvement in IC patients participating in an~     exercise programme~      Patients: Patients with documented IC referred from a Vascular Consultant. Eligible patients~     will be invited to participate in a 12 week supervised exercise programme.~      Testing Schedule: Measurements will be recorded at baseline (prior to exercise), immediately~     after the completion of the exercise programme and then three months after. Measurements~     include:~      Baseline characteristics that might predict outcome:~        -  Quality of life using the VascuQol questionnaire~        -  Clinical indicators of lower limb function: Ankle brachial pressure index (ABPI),~          intermittent claudication distance (ICD), Maximum walking distance (MWD).~      Candidate physiological mechanisms~        -  Aerobic capacity (VO2 max & AT)~        -  Muscular strength and endurance~        -  Muscle morphology (including muscle thickness, pennation angle, fascicle length and~          elastography)~        -  Endothelial function (sheer stress response as measured by flow mediated dilation)~      Analysis: Regression analysis will be used to explain variation in patient maximum walking~     distance at 3 months. The regression will use 9 candidate measures of physiological response~     and 3 baseline measures to explore what mechanism and patient factors may be associated with~     clinical improvements. 100 patients recruited over 2 years will give a 90% power to detect an~     additional increase in variability in MWD explained by each candidate measure of around 5% at~     the a 0.05 significance level.~      This research will be used to identify which types of exercise may be most influential in~     improving outcome and in which patients.~      Workstream two~      Objective:~      Explore the reasons behind patients' participation, non-participation in, experience of and~     adherence to the exercise programme.~      Study Design: An interview study of patients with IC routinely referred for supervised~     exercise. Three groups of patients will be invited to participate. Those who:~        -  Choose not to participate in the exercise programme (Group A)~        -  Agree to participate in the exercise programme (Group B).~        -  Agree to participate but discontinue after at least one session (Group C).~      Semi-structured face-to-face interviews with 20 patients per group, interviews will be~     conducted using a topic guide to ensure consistency. The format will be flexible to allow~     participants to generate naturalistic data on what they consider as important and / or~     successful in terms of outcome. Data will be analysed thematically and managed using Nvivo~     software - the approach will be inductive and iterative.~      This research will be used to redesign the current exercise programme to improve~     participation and so the impact of exercise in patients with IC.~   "
70712|NCT02641405|"~     It's already known the efficacy of Gait Analysis (GA) on evaluating gait modification on~     Parkinson's Disease (PD) Patients (1). On the other hand Proprioceptive Focal Stimulation~     seems be useful in symptoms amelioration in several neurological disease. Few studies have~     been performed in Parkinson's disease. A total of 126 patients suffering from PD will be~     recruited in 6 italian neurological centers. The study will be a cross-over multicenter study~     with the randomization of the sequence. The patients will be randomly assigned to 2 groups~     receiving for 8 weeks either the Equistasi medical device, or an equivalent placebo. Gait~     analysis will be recorded in each patient at the beginning and at the end of the treatment~     assigned. After 4 weeks of wash-out, the treatment will be crossed and a new gait analysis~     recording will be performed. Finally a last recording will be taken at the end of the last 8~     weeks. Secondary outcome will be the MDS-UPDRS (Movement Disorder Society - Unified Parkinson~     Disease Rating Scale), PDQ-39 (Parkinson Disease 39 Questionnaire ), ABC (Activity Specific~     Balance Confidence Scale).~   "
70713|NCT02641392|"~     The purpose of this study is to assess long-term safety data of GED-0301 for a period of up~     to 208 weeks in adult subjects (i.e., ≥ 18 years of age) who participated in the core Phase 3~     GED-0301-CD-002 and GED-0301-CD-003 studies and adolescent subjects (i.e., 12 to 17 years of~     age) who participated in the core Phase 3 GED-0301-CD-003 study. Although all subjects will~     receive active treatment, this study is double-blinded for the entire 208 weeks for the~     purpose of preserving the blind of the subject's treatment allocation in the initial, core~     Phase 3 GED-0301 study.~   "
70714|NCT02641379|"~     This study will compare the efficacy and safety of 2 different treatment durations of~     peginterferon alfa-2a (Pegasys) plus ribavirin in patients with CHC. The anticipated time on~     study treatment is 1-2 years, and the target sample size is greater than (>) 500 individuals.~   "
71613|NCT02629562|"~     Multi-centre, double-blind, randomised, 2-way cross-over study to investigate the PK and PD~     of B12019 as compared to Neulasta® administered as a single subcutaneous (s.c.) dose in~     healthy male subjects. B12019 or Neulasta will be administered by s.c. injection.~   "
70715|NCT02641366|"~     Deep Brain Stimulation (DBS) is an effective treatment option for individuals with~     debilitating tremors that do not respond to medical therapy. However, severe tremors,~     particularly those that develop after central nervous system insult or from multiple~     sclerosis, can be comprised of several underlying components that represent dysfunction~     within distinct brain circuits. Some of these dysfunctional brain circuits can be~     successfully treated with DBS while others respond poorly DBS therapy. For severe tremors, it~     can be very difficult to discriminate between the underlying components of a patient movement~     disorder and is exclusively dependent upon clinical expertise. Even with extensive clinical~     experience, it is difficult to reliably predict the results of DBS therapy for patients~     suffering from severe, debilitating tremor. In an attempt to gain more knowledge, an~     electromagnetic tracking system will be used which can precisely measure the position of a~     patient's upper extremity in space during routine neurologic examination. The goal is to use~     this tool to quantitatively identify various components of severe tremor, which can be~     discriminated based on oscillatory frequency and regularity of tremor amplitude. The purpose~     of this research study is to better understand the nature of complex, severe tremors by~     carefully measuring movement of the upper extremities with sensors during simple tasks. The~     goal is to break down complicated tremors into their components and then determine which~     components will respond to deep brain stimulation.~   "
70716|NCT02641353|"~     The purpose of this study is to assess how much of apremilast is found in the blood unchanged~     when administered as an oral suspension compared to when it is administered as a tablet~     formulation. The effect of food on apremilast oral suspension will also be evaluated. In~     addition, information on the safety and tolerability of apremilast will be obtained.~      CC-10004 (also known as apremilast or Otezla®) has been approved by the Food and Drug~     Administration (FDA) for the treatment of active psoriatic arthritis (PsA) and moderate to~     severe plaque psoriasis in adults. The liquid formulation of apremilast is an investigational~     drug being developed by Celgene Corporation to treat plaque psoriasis in children. An~     investigational drug is not approved by the U.S. Food and Drug Administration (FDA).~   "
70717|NCT02641340|"~     The primary objective of this trial is to determine the pharmacokinetic and pharmacodynamic~     relationship of multiple dose administration of fentanyl sublingual spray in opioid naive~     participants. The secondary objective is to determine the safety and tolerability of multiple~     dose administration of fentanyl sublingual spray in opioid naive subjects.~   "
70718|NCT02641327|"~     The study objective is to assess the accuracy of Earlysense contactless monitoring to detect~     changes in blood pressure vs. Gold reference method / devices including ambulatory blood~     pressure monitoring device (ABPM) or invasive blood pressure monitoring for patients who have~     arterial line as part of their standard clinical care.~   "
70719|NCT02641314|"~     Neuroblastoma is the second most frequent cause for death from cancer in childhood. Already~     one year after diagnosis of recurrence from high risk neuroblastoma, 75% of the patients~     experience further progression.~      Metronomic therapy is targeting not only the tumor cell, but also the tumor supplying~     vasculature and the interactions between Tumor and immune cells. The toxicity is expected to~     be low due to the low (but continuous) dosing of drugs.~      The study investigates the tolerance and the efficacy of a new combination of five drugs~     consisting of propranolol (antiangiogenetic, anti-neuroblastic), Celecoxib (modulating immune~     response, ant-neuroblastic), cyclophosphamide (antiangiogenetic, anti-neuroblastic),~     etoposide (antiangiogenetic, anti-neuroblastic), and vinblastin (antiangiogenetic,~     anti-neuroblastic). Vinblastin is scheduled every 14 days intravenously, all other drugs are~     applied daily throughout 365 days (except etoposide for 4x3 weeks). The efficacies of each of~     the drugs have been demonstrated in vitro and in vivo in animal studies. All drugs have been~     used in children for other conditions. From those experiences low toxicities and a favorable~     Quality of life are expected.~   "
70720|NCT02641301|"~     The purpose of this study is to determine whether sustained release morphine pharmacokinetics~     parameters in patients undergone roux-en-y gastric bypass (RYGB) differ from subjects who did~     not. Our hypothesis is that exposure is comparable. Indeed, in the Study OBEMO (Determinants~     of Oral Morphine Answer Among Obese Patients Before and After Gastric Bypass; NCT00943969)~     the investigators observed changes in pharmacokinetics parameters for immediate release~     morphine, probably due to an earlier absorption of the morphine, in agreement with the~     expected clinical effect of this formulation.~   "
70721|NCT02641288|"~     A prospective randomized clinical trial of all the patients undergoing laparoscopic sleeve~     gastrectomy (LSG) or laparoscopic Roux-en-Y gastric bypass (LRYGB) will be performed.~     Patients will be randomized in 2 groups: those patients undergoing intraperitoneal~     ropivacaine irrigation (Experimental Group - EG) and those undergoing intraperitoneal~     irrigation with normal saline (Control Group - CG).~   "
70722|NCT02641275|"~     The relentless progressive process of muscular dystrophy requires extraordinary medical,~     physical, and emotional care with severe consequences for caring parents (increased stress~     and diminished social, psychological and physical well-being). Despite the obvious need of~     support for parents only few and weak data exist regarding efficiency and efficacy of~     specific interventions supporting parental resilience and coping strategies. The presenting~     study aims to fill this gap by evaluating the efficacy of a structured self-management~     training for parents of children with severe progressive muscular dystrophy compared to~     parents receiving treatment as usual (TAU). In addition, investigators measure established~     biomarkers of psychosocial stress, such as pro-inflammatory cytokines, which will be used to~     monitor physiological changes with assumed significance for parental health.~   "
70723|NCT02641262|"~     ST-segment elevation myocardial infarction (STEMI) remains among the most acute and critical~     diseases, with primary percutaneous coronary intervention (pPCI) and thrombolysis as mainstay~     reperfusion treatments. Real-world implementation of current guidelines for STEMI management~     has been assessed in developed countries and large Chinese cities. However, until now, there~     has been no registry on patients with STEMI in Henan, the most populated (about 100 million)~     and predominantly rural (66%) province in central China.~      This registry is aimed to assess management practices, time delays, outcomes and reasons for~     not receiving reperfusion therapy in consecutive STEMI patients in reperfusion-capable~     hospitals, i.e., tertiary and secondary, in Henan province.~   "
84863|NCT02456233|"~     This prospective randomized study will assess the safety and efficacy of FIRM-guided ablation~     (FIRM+PVI) compared to pulmonary vein isolation (PVI) without FIRM, for the treatment of~     symptomatic atrial fibrillation.~   "
70724|NCT02641249|"~     Purpose of Study: Apnea of Prematurity (AOP) is common, affecting the majority of infants~     born <34 weeks gestational age (GA). Apnea is accompanied by intermittent hypoxia (IH), which~     contributes to multiple pathologies, including retinopathy of prematurity (ROP), sympathetic~     ganglia injury, impaired pancreatic islet cell and bone development, and neurodevelopmental~     disabilities. Standard of care for AOP/IH includes prone positioning, positive pressure~     ventilation, and caffeine therapy, none of which is optimal. The objective is to support~     breathing in premature infants by using a simple, non-invasive vibratory device placed over~     limb proprioceptor fibers, an intervention using the principle that limb movements facilitate~     breathing.~      Methods Used: Premature infants (23-34 wks GA) with clinical evidence of AOP/IH were enrolled~     1 week after birth. Caffeine therapy was not a reason for exclusion. Small vibration devices~     were placed on one hand and one foot and activated in a 6 hour ON/OFF sequence for a total of~     24 hours. Heart rate, respiratory rate, oxygen saturation (SpO2), and breathing pauses were~     continuously collected.~   "
70725|NCT02641236|"~     This research study is for participants who are undergoing allogeneic hematopoietic stem cell~     transplantation (HSCT) and are at risk for developing acute graft-versus-host disease (GVHD).~     GVHD is a complication of HSCT in which immune cells from the donor cause inflammation and~     injury to tissues and organs of the HSCT recipient. Vancomycin-polymyxin B (commonly called~     vancopoly) is an oral antibiotic that is given to people undergoing allogeneic HSCT as a~     preventive measure for acute GVHD. This research study is studying the effects of vancopoly~     on the microorganisms living in the intestine during and after stem cell transplantation.~   "
70726|NCT02641223|"~     For this study the investigators will conduct five-day trial periods for spinal cord~     stimulator (SCS) effectiveness—once a patient is deemed to be a possible SCS candidate, the~     trial leads are implanted and they are asked to return to clinic in five days to evaluate the~     effectiveness of the trial. The primary outcome for this study will be a comparison of daily~     energy expenditure (EE), in units of kcal/day, prior to and after the trial implantation of~     the SCS leads and external pulse generator. Patients will wear the accelerometer device~     twenty-four hours a day for five days prior to the trial lead implantation to obtain baseline~     values, have the trial leads implanted in the procedure clinic, then continue to wear the~     accelerometer for another five days. Baseline and post-SCS energy expenditure values will be~     compared. The secondary outcomes for this study will be steps taken, hours of sleep, and~     Oswestry Disability Index (ODI, as described in appendix 1) during the pre and post trial~     implantation periods. SCS itself is not a research procedure in this study, rather it is part~     of routine medical care for patients who would benefit from the procedure.~   "
70727|NCT02641210|"~     Periodontitis is an inflammatory/infectious disease of high prevalence in the population and~     which has been linked to several chronic inflammatory systemic diseases. However, few studies~     have evaluated the periodontal disease in the absence of other inflammatory conditions~     stimulate inflammatory markers as C-reactive protein (CRP), Interleukin - 6 (IL-6) hepcidin~     and hemoglobin. The aim of this study was to evaluate the influence of nonsurgical~     periodontal therapy on the change of inflammatory markers and anemia in control subjects and~     patients with chronic periodontitis after three months.This interventional study included 67~     individuals of both sexes, aged 30-65 years, without other diseases, except chronic~     periodontitis, with at least 20 teeth, selected from a total 125 individuals following the~     eligibility criteria. Periodontal clinical parameters (probing depth, bleeding on probing,~     clinical attachment level) and systemic, hematological as well as inflammatory markers CRP,~     IL-6 and hepcidin were compared before and after nonsurgical periodontal therapy by serum and~     plasma examination of control individuals and patients with chronic periodontitis.~   "
70728|NCT02641197|"~     The objective of this study is to define the repeatability and reproducibility of quantifying~     flow-mediated dilation (FMD) of the brachial artery (BA) using the AngioDefender (AD)~     methodology.~      Repeatability will be assessed by repeat AD testing of the same subject 1 hour apart, using~     the same AD device and operator.~      Reproducibility will be assessed by comparing FMD scores obtained for the same subject, but~     using different AD devices and operators.~   "
70729|NCT02641184|"~     The aim of this study is to investigate the potential novel risk factors for acute myocardial~     infarction. Predictors of poor outcomes will be also evaluated.~   "
70730|NCT02641171|"~     This study evaluates the use of exhaled air analysis as tool to monitor the disease activity~     in Crohn's Disease (CD). This study is a validation of the previous findings. In this study~     the participant will be asked to donate exhaled air, blood samples and fecal samples. The~     breath samples will be used to measure various volatile metabolites in breath. The breath air~     will be next used to validate the previous findings. The blood samples will be used to define~     the origin of volatile metabolites in breath. Finally, the potential of exhaled breath~     analysis as non-invasive marker of diseases activity will be compared to established fecal~     calprotectin.~   "
70731|NCT02641158|"~     Primary Objective: This study will evaluate the effectiveness of an HCV Care Facilitation~     intervention in moving HIV/HCV co-infected substance users forward along the HCV care~     continuum (compared with a Control group).~      Primary Hypothesis: The number of steps achieved along the HCV care continuum will differ~     between the two study groups over the 14-month follow-up period.~      Secondary Objectives:~      Component 1 (Long-term CTN 0049 follow-up):~      Using the CTN 0064 baseline data (self-report, medical record abstraction and biological~     data), the following CTN 0049 primary and secondary outcomes in participants who consented to~     the CTN 0064 protocol will be re-analyzed to evaluate latent and/or enduring effects of the~     CTN 0049 interventions:~        1. HIV virological suppression~        2. HIV primary care visit attendance~        3. All-cause mortality~   "
70732|NCT02641145|"~     Cardiac amyloidosis is a major cause of early treatment-related death and poor overall~     survival in individuals with systemic light chain amyloidosis. This project will develop a~     novel approach to visualize cardiac amyloid deposits using advanced imaging methods. The~     long-term goal of this work is to identify the mechanisms of cardiac dysfunction, in order to~     guide the development of novel life-saving treatments.~   "
70733|NCT02641132|"~     To evaluate changes in endothelial cell count after pterygium surgery with mitomycin C (MMC)~     0.02%~   "
70734|NCT02641119|"~     This observational study evaluates the potential benefits, costs and clinical outcomes of~     albumin over saline and other non-saline fluids in patients receiving large volume~     resuscitation.~   "
70735|NCT02641106|"~     The three-month short-course treatment with isoniazid [H] and rifapentine [P] (3HP) recently~     recommended by the Centers for Disease Control and Prevention could dramatically increase the~     number of persons starting and completing treatment for latent tuberculosis infection (LTBI),~     but TB providers nationwide are hamstrung by the requirement that 3HP only be administered by~     directly observed therapy (DOT) in which patients are watched taking each medication dose~     in-person. We developed a novel mHealth application that allows patients to make and send~     videos of each medication dose ingested that are watched by healthcare providers via a~     HIPAA-compliant website to remotely monitor LTBI treatment adherence (Video DOT [VDOT]). This~     study will determine whether monitoring patients with VDOT achieves higher treatment~     completion rates and greater patient acceptability at lower cost than clinic-based in-person~     DOT.~   "
70736|NCT02641093|"~     The purpose of this research study is to test the safety and the benefit of adding~     pembrolizumab (a therapy that activates the immune system to fight cancer) to standard of~     care treatment for head and neck cancer. The standard of care treatment will include surgery~     followed by radiation for 6 weeks. Some patients may also receive cisplatin as standard of~     care once a week for 6 weeks if the cancer is found to be high risk. High risk includes~     cancer that was not completely removed (positive margins) or cancer that has invaded through~     the outer lining of your lymph nodes.~   "
70737|NCT02641080|"~     For patients undergoing total hip and knee arthroplasty, does the use of Aspirin alone~     compared to using Aspirin along with a mobile compression device provide equivocal results~     for preventing Deep Vein Thrombosis (DVT) and pulmonary embolism (PE) after total joint~     arthroplasty? The investigator will evaluate the prevention of DVT/PE after total hip and~     knee arthroplasty will be evaluated to see if there is a decreased risk of bleeding while~     continuing to prevent thromboembolic disease. The equivalency of using the mobile compression~     devices with aspirin compared to aspirin alone in patients undergoing total hip and knee~     arthroplasty will be evaluated. A previous study has shown that patient compliance with the~     pneumatic compression device is less than 80%.~   "
70738|NCT02641067|"~     This study will evaluate the effect of severe renal impairment on the pharmacokinetics of~     doravirine.~   "
70739|NCT02641054|"~     CVXL-0107 a glutamate release inhibitor, has shown evidence of antiparkinsonian and~     antidyskinetic activity in a macaque model and has shown a significant effect on the~     UPDRS-III (Movement Disorder Society - Unified Parkinson's Disease Rating Scale) while ON,~     as well as an increase of ON-time without dyskinesia or without troublesome dyskinesia in a~     previous phase 2a proof of concept study. This study will confirm the efficacy of CVXL-0107~     in combination with optimal dose of levodopa on motor symptoms of Parkinson's disease (PD) .~   "
70740|NCT02641041|"~     The primary objective of this study is to assess the safety and tolerability of a single dose~     and multiple doses of BIIB033 administered to healthy adult Japanese participants. The~     secondary objectives of this study are to evaluate the pharmacokinetics (PK) profile of~     BIIB033 administered as single and multiple doses in healthy adult Japanese participants and~     to assess the single-dose and multiple-dose immunogenicity of BIIB033.~   "
70741|NCT02641028|"~     A Randomized, Double-Blind, Placebo-Controlled, Crossover Design Study of CERC-501 in a Human~     Laboratory Model of Smoking Behavior.~   "
70742|NCT02641015|"~     A retrospective observational study to assess the clinical management and outcomes of~     hospitalised patients with complicated urinary tract infection in countries with high~     prevalence of multidrug resistant gram-negative bacteria (COMBACTE-MAGNET,WP5)~   "
70743|NCT02641002|"~     Study CC-90002-AML-001 is an open-label, Phase 1 dose escalation (Part A) and expansion (Part~     B), clinical study of CC-90002, administered by intravenous (IV) infusion, in subjects with~     relapsed and/or primary refractory AML and high-risk MDS. The study will explore escalating~     doses of CC-90002 using a 3 + 3 dose escalation design in Part A, followed by dose expansion~     in Part B.~      The primary objective is to determine the safety and tolerability of CC-90002 and also to~     define the non-tolerated dose (NTD), the maximum tolerated dose (MTD) and/or the recommended~     Phase 2 dose (RP2D) of CC-90002.~   "
70744|NCT02640989|"~     The purpose of this study is to assess the safety and immunogenicity of three seasonal~     trivalent influenza vaccines (TIVs)manufactured by Glaxosmith Kline (GSK), Beijing Sinovac~     Biotech (Sinovac) and Shenzhen Sanofi Pasteur (Pasteur) in Chinese healthy servicemen. Using~     imported GSK's TIV as control, to compare it with other two domestic TIVs in Chinese healthy~     servicemen.~   "
70745|NCT02640976|"~     The aim of this study is to assess the role of AMH in prediction of poor ovarian response as~     well as the relation between ESR2 (+1730G>A) (rs4986938), FSHR p.Thr307Ala (c.919A>G, rs6165)~     and FSHR p.Asn680Ser (c.2039A>G, rs6166) SNPs and the poor response in Egyptian women~     undergoing IVF procedure. Discovering the genetic variants associated with ovarian response~     is an important step towards individualized pharmacogenetic protocols of ovarian stimulation.~   "
70746|NCT02640963|"~     This study is a pilot study (feasibility and acceptability study), which will compare~     feasibility and efficacy outcomes between a 12-week Exercise Program and control group in RAC~     residents.~   "
70747|NCT02640950|"~     Transcranial Magnetic Stimulation (TMS) is an increasingly accepted neurostimulation- based~     treatment for major depressive disorder. While there is a growing anecdotal database~     supporting its use in bipolar depression the investigators propose to collect open label~     efficacy and safety data in a small population of patients with clinically verified bipolar~     disorder.~   "
70758|NCT02640807|"~     A multicenter, randomized, double-blinded, placebo-controlled study of two dosing frequencies~     of recombinant Interleukin-7 (CYT107) treatment to restore absolute lymphocyte counts in~     sepsis patients; IRIS-7B (Immune Reconstitution of Immunosuppressed Sepsis patients).~      A parallel study will be performed in France to allow a common statistical analysis of the~     primary end points and analysis for the enrolled patient population.~   "
70759|NCT02640794|"~     The purpose of this study is to compare aspirin/acetylsalicylic acid+ clopidogrel with~     aspirin/acetylsalicylic acid alone as antithrombotic treatment following TAVI for the~     prevention of major ischemic events (MI, ischemic stroke) or death without increasing the~     risk of major bleeding events.~   "
71906|NCT02625740|"~     The PACUS Trial was a single center, single blinded, randomized trial designed to evaluate~     the safety and efficacy of intravascular percutaneous catheter-delivered ultrasound energy to~     improve local Paclitaxel delivery effects in critical limb ischemia patients due to~     femoral-popliteal artery disease.~   "
70748|NCT02640937|"~     This was a prospective study performed between November 2011 and September 2013. Patients~     with a confirmed S. epidermidis infection after fracture fixation or prosthetic joint~     infection were included. Exclusion criteria included infections involving external fixation~     pins, infections without any implanted hardware and culture positive patients not displaying~     any clinical sign of infection. The following surgical parameters were documented: affected~     bone or joint; type of implant; time between implantation of the device and onset of~     symptoms. Personal characteristics and patients`health status were also documented. Any~     revision surgeries involving the site of interest and all isolated pathogens were recorded~     throughout the course of treatment and follow-up.~      A follow up examination was performed an average of 26 months after discharge. Primary~     outcome at follow up was cure. Cure was define by the authors as: missing local (at site of~     interest) or systemic signs of infection, terminated surgical and systemic therapy and~     restoration of joint or limb function.~      At the first surgical procedure after enrolment, at least four deep bone biopsies were taken~     from the interface between implant and affected bone. Identification and antibiotic~     susceptibility testing of all growth was performed. Multi-drug-resistance (MDR) was defined~     according to the definitions of the European Committee of Antimicrobial Susceptibility~     Testing (EUCAST). Biofilm formation was analysed and quantified in microtitre plate assays~     according to protocol of Stepanovic et al.(see references).~   "
70749|NCT02640924|"~     Hepatocellular carcinoma (HCC) is one of the most common cancers in Taiwan, where chronic~     viral hepatitis is common. Patients with HCC typically have impaired liver function because~     of virus- or alcohol- induced cirrhosis and viral hepatitis, and only approximately 20% of~     them are appropriate candidates for surgery. The 5-year overall survival for patients treated~     by surgery is approximately 30%-70%. For those not treated with surgery, liver function~     affected by an underlying liver disease has a strong influence on clinical outcomes, and~     complicates treatment strategies further than for other tumors. Maximal preservation of~     normal liver volume and function is an important consideration in the choice of treatment.~      Proton beam has been applied to HCC treatment in Japan for longer than a decade, and several~     retrospective results showed excellent 3-5 years local control rate ranging from 85-95% and~     nearly no major complications. The investigators also retrospectively reviewed 75 index~     tumors sized 3.1-7.0cm in 70 patients receiving multiple-electrode radiofrequency ablation~     with switching controller (ME-SWC RFA) treatments in the period between 1 January 2009 and 31~     December 2011 (Oral report in Taiwan Digestive Disease Week, October, 2012). Estimated 1-,~     2-, and 3-year cumulative overall survival rates and local control rates were 94%, 85%, 81%~     and 89%, 83%, 67%, respectively.~      Since ME-SWC RFA is the present one of standard modalities for non-surgery, moderate to~     larger (3-7 cm) HCC, and based on retrospective studies the local control rate of proton~     therapy was better than radiofrequency ablation, this prospective trial is aimed to compare~     the effects of these two modalities in 3-7 cm HCC patients who are not candidates for surgery~     or refuse surgery. This prospective study has high possibility to confirm the role of proton~     beam in HCC.~      Along with the clinical trial, the investigators will also use next generation sequencing~     (NGS) to exam gene expression profile of tumor samples and find out candidate genes related~     to local control, intrahepatic control (treatment out-field control in liver), regional lymph~     node relapse, distant metastasis, and treatment response in HCC.~   "
70750|NCT02640911|"~     This multi-centre study will evaluate the safety and related factors study of atypical~     antipsychotics long-term treatment in Chinese Patients with Schizophrenia. The atypical~     antipsychotics include quetiapine, olanzapine, risperidone, aripiprazole, ziprasidone,~     paliperidone , amisulpride , perospirone and clozapine. This is an open, cohort, multi-center~     observational clinical study. The main purpose is to evaluate the safety. And the second~     purpose is to evaluate the efficacy of atypical antipsychotics. The efficacy evaluations~     include symptoms, social function, recurrence rate and hospitalization. This study belongs to~     IV period post-marketing drugs research. Planned sample size is 3000 cases.~      Visits occurs at 0,4,8,13,26,52,78,104,130 and 156 weeks. The main indexes include physical~     examination, vital signs, abdominal circumference , laboratory tests (blood cell analysis/~     blood biochemical tests / prolactin (PRL) / thyroxine, etc.), adverse events, 12-lead~     electrocardiogram( ECG), extrapyramidal syndrome(EPS )assessment, sexual function evaluation,~     medication and other subjective feelings. The second indexes include scales of Positive and~     Negative Syndrome Scale(PANSS)，Clinical Global Impression-severity of Illness Scale(CGI-S),~     Calgary Depression Scale for Schizophrenia(CDSS),Personal and Social Performance Scale(PSP),~     the MOS 36一item Short Form Health Survey(SF-36), relapse rate, drug consolidation,~     medical-related expenses, income, drug plasma concentration and genetic information.~   "
70751|NCT02640898|"~     Although the intergroup 0116 trial was the first to demonstrate that adjuvant~     chemoradiotherapy offers a significant survival benefit in completely resected gastric~     cancer,it is more toxic and less effective. It is reasonable to optimize this regimen.~   "
70752|NCT02640885|"~     Post-partum haemorrhage due to placenta previa is usually from the placental bed at the lower~     uterine segment and it occurs after the placenta separation. Although, nowadays the~     obstetrician can diagnose placenta previa before delivery, it is still one of the important~     causes of maternal mortality . Hysterectomy can be the only effective action to take,~     although it carries many morbidities for the women especially those with low parity.~      Uterine packing considers as a line of treatment before performing surgical procedures in~     postpartum hemorrhage resulting from placental site bleeding. It can save life, avoid~     laparotomy and save uterus.~      Nowadays, the use of intrauterine balloons have been developed and become effective for the~     control of placental site bleeding not responding to medical treatment. The 2-way Foley's~     Cather has many advantages over the gauze packing; First, it allows drainage of blood so no~     occult bleeding could be accumulated inside the uterus as in uterine gauze, second the~     removal of the Foley's Cather balloon is easy and not a painful, third, the removal of 2-way~     Foley's Cather could be gradually as a test of its effectiveness before complete removal .~   "
70753|NCT02640872|"~     This study is a hospital-based, prospective cohort study to elucidate the predictive factors~     including muscle and fat mass for chronic diseases and mortality in elderly persons aged 60~     years and older.~   "
70754|NCT02640859|"~     A cohort study with Korean adults to investigate biomarkers in prediction of cardiometabolic~     and other diseases~   "
70755|NCT02640846|"~     The aim of this study is to compare the effects of milrinone(Corotrope) and~     levosimendan(Simdax) on septic cardiomyopathy using pulmonary artery catheter, conventional~     and strain echocardiography.~   "
70756|NCT02640833|"~     This study is designed to assess the safety, pharmacokinetics, drug-drug interactions, and~     determine the recommended Phase 2 doses of co administered Duvelisib and Venetoclax in~     participants with relapsed or refractory chronic lymphocytic leukemia (CLL), small~     lymphocytic lymphoma, or indolent or aggressive non-Hodgkin lymphoma, who have not previously~     received a Bcl-2 or Phosphoinositide 3-kinase (PI3K) inhibitor. The Phase 2 portion of the~     study will preliminarily evaluate efficacy, and expand the toxicity evaluation.~   "
70760|NCT02640781|"~     Acute colorectal obstruction has been reported to occur in 7 - 29% of all colorectal~     malignancies, but emergent surgical decompression is associated with high morbidity and~     mortality rates. Recently, self-expandable metal stents(SEMS) have been suggested as an~     alternative to surgery and effectively decompress the colonic obstruction and allow for bowel~     preparation and elective surgery. Theoretically, SEMSs are classified into uncovered stents~     and covered stents. Covered stents have the advantage of less frequent stent occlusion by~     tumor in-growth and the disadvantage of a high risk of stent migration, whereas uncovered~     stents are associated with less stent migration, although they appear to be more prone to~     tumor ingrowth. To overcome the drawbacks of conventional stents, a double-layered~     combination covered stent was developed. In the present study, the investigators evaluated~     the efficacy and safety of the newly designed covered stent by comparing it with the~     uncovered stent in patients with malignant colorectal obstruction.~   "
70761|NCT02640768|"~     The prevalence of diabetes among inpatients in medical wards, surgery and intensive care~     units in Italy is approximatively 12-25%. The management of in hospital diabetes and~     hyperglycemia is complex and requires a specific training for physicians and nurses in~     non-specialist settings. The overall project aims at the implementation of a best practice~     model of care for hospitalized diabetic patients in non-specialist settings.~   "
70762|NCT02640755|"~     This Phase 1, open label, single centre, non-randomised study in patients with advanced solid~     malignancies consists of two parts:~        1. Single Dose Period - will characterise the absorption, metabolism, excretion and~          pharmacokinetics of a single oral dose of [14C]AZD2014 from the body~        2. Multiple Dose Period - will further assess the safety and tolerability and anti-tumour~          activity of multiple doses of AZD2014 when given as a monotherapy or given in~          combination with paclitaxel or fulvestrant.~   "
70763|NCT02640742|"~     This study aims to evaluate the asthma control status, asthma symptoms (severity, frequency,~     and limitations on activities, etc.), QOL, and use of drugs for asthma attack in adult asthma~     patients.~   "
70764|NCT02640729|"~     This study seeks to evaluate safety and efficacy of Nelotanserin for the treatment of visual~     hallucinations in subjects with Lewy body dementia.~   "
70765|NCT02640716|"~     This study evaluates the efficacy and mechanism of internet-based cognitive training in~     patients with subcortical VCIND. Half of participants will receive multi-domain adaptive~     internet-based training program, while the other half will receive a fixed, primary~     difficulty level task.~   "
70766|NCT02640703|"~     Hypoxia/bradycardia are common symptoms after vaccination of preterm infants. Adults show~     diurnal variations in vaccination response, due to circadian regulation of the immune system.~     The investigators plan to investigate whether preterm infants also show differences in~     hypoxia/bradycardia rate upon morning vs. evening vaccination.~      Hypoxia/bradycardia is recorded by pulse oximetry starting 24 hours before until 48 hours~     after vaccination; parents also kept a sleep-diary. 24 hours after vaccination interleukin-6,~     interleukin-1β and C-reactive protein get determined. To control vaccination response,~     pertussis- and haemophilus-titers are determined before vaccination and at 4 months corrected~     age.~   "
70767|NCT02640690|"~     In this study, we are evaluating the effectiveness of a yoga intervention to treat~     posttraumatic stress disorder (PTSD), its associated symptoms of chronic pain and insomnia,~     and biological and physiological responses to trauma and PTSD in women Veterans who~     experienced military sexual trauma (MST). If effective, this yoga intervention could reduce~     PTSD symptoms and chronic pain, improve sleep quality, and decrease the body's automatic~     fight or flight stress response and the damage this stress response causes in the body,~     including heart disease and diabetes. This intervention could improve these women Veterans'~     quality of life and social functioning, for example, going to work and having satisfying~     relationships with family and friends. This study may support an innovative, complementary~     and alternative PTSD treatment for women Veterans who experienced MST. This new,~     evidence-based PTSD treatment could supplement current PTSD treatments. Clinical guidelines~     for this yoga intervention could be implemented nationally in the VA health care system.~   "
70768|NCT02640677|"~     4CMenB was approved by the Food and Drug Administration (FDA) in the United States in January~     2015 for people aged 10 through 25 years of age. 4CMenB should be used during pregnancy only~     if clearly needed and sometimes, inadvertent exposure during pregnancy may also occur -~     before the woman knows she is pregnant, for example. The objective of this study is to~     evaluate the safety of 4CMenB during pregnancy and to help us learn more about the health of~     women who have been vaccinated with 4CMenB within 30 days prior to their last menstrual~     period (LMP) or at any time during pregnancy, and the health of their infants. Pregnant women~     within the US who received at least 1 dose 4CMenB vaccine within 30 days prior to their last~     menstrual period or at any time during pregnancy are eligible to participate. A woman may~     self-enroll in the registry by calling the pregnancy registry telephone number directly or~     their healthcare provider (HCP) can, with their consent, enroll them on their behalf.~     Alternatively HCPs may report anonymous data on pregnancy exposures and outcomes occurring~     within their network/health maintenance organization (HMO). The health of the woman and her~     infant will be followed up until the end of the pregnancy.~   "
70769|NCT02640664|"~     The purpose of this study is to evaluate the long term efficacy and safety of intravitreal~     ranibizumab compared with laser ablation therapy in patients who were treated for retinopathy~     of prematurity (ROP) in the core study CRFB002H2301~   "
70770|NCT02640651|"~     The purpose of this pilot study is to determine whether transcranial direct current~     stimulation safely and effectively improves symptoms of ADHD.~   "
70771|NCT02640638|"~     The purpose of this study is to evaluate whether CenteringPregnancy group prenatal care can~     improve preterm birth rate and other birth outcomes, maternal psychosocial and behavioral~     outcomes, and decrease the racial difference in selected birth outcomes among African~     American and White women, compared to individual prenatal care.~   "
70772|NCT02640625|"~     The primary objective of this study is to assess the safety of probiotics in cART-treated~     immunologic non-responder (INR) patients with chronic HIV infection.~      The secondary objectives are to i) explore the biological effects of probiotics in combined~     antiretroviral therapy(cART)-treated INR patient with chronic HIV infection, and ii)~     investigate differences between cART-treated HIV-infected INR and non-INR patients with~     regards to gut microbial composition and mucosal barrier function.~   "
70773|NCT02640612|"~     The main objective of this trial is to provide long-term safety, PK, and immunogenicity data~     on BI 695501 administered via prefilled syringe in patients with Rheumatoid Arthritis who~     have completed Trial 1297.2. The primary endpoint thereby is the number (proportion) of~     patients with drug-related AEs during the treatment phase. The secondary objective in this~     trial is the assessment of Long-term efficacy of BI 695501 by evaluation of:~        -  the change from Baseline in DAS28 (ESR) at Week 48~        -  the proportion of patients meeting ACR20 response criteria at Week 48~        -  the proportion of patients who meet the ACR/European League Against Rheumatism (EULAR)~          definition of remission at Week 48~        -  the proportion of patients with EULAR response (good response, moderate response, or no~          response) at Week 48.~   "
70774|NCT02640599|"~     Investigators will use a stationary bike protocol to investigate whether patients with post~     concussion syndrome benefit from adding exertion training to a vestibular rehabilitation~     program.~      Investigators examine the effect of aerobic exercise testing and training on individuals with~     concussion who are currently experiencing symptoms and examine the effect of aerobic exercise~     in combination with traditional vestibular rehabilitation.~   "
70775|NCT02640586|"~     The purpose of this study is to investigate if MRI scans performed after neoadjuvant~     radiotherapy can predict the therapeutic response of rectal cancer following preoperative~     chemo-radiotherapy. This will help doctors to better tailor treatments for rectal cancer in~     the future.~   "
70776|NCT02640573|"~     Sickle cell disease (SCD), specifically hemoglobin SC disease (HbSC), is a subtype of sickle~     cell disease with typically higher hemoglobin and milder or later disease complications.~     Sickle cell disease is a disorder in which red blood cells (RBCs) are abnormally shaped. This~     can result in painful episodes, serious infections, and damage to body organs. One medication~     used to treat sickle cell disease is hydroxyurea.~      Hydroxyurea therapy offers significant benefits for infants, children, and adolescents with~     sickle cell anemia. These include a reduction in the frequency of pain crises and acute chest~     syndrome (inflammation of the lungs). Hydroxyurea has been given to many HbSC patients but~     HbSC patients were not included in the large clinical trials used to test hydroxyurea in SCD,~     so less is known about how HbSC patients respond to hydroxyurea.~      The purpose of this research study is to see if hydroxyurea, a medication given to many~     patients with the most common type of sickle cell, those who are homozygous for the sickle~     mutation (HbSS), helps individuals who have HbSC. The investigators will see if it helps by~     giving a questionaire when the medication is started, and then every two months at a clinic~     visit. The questionaire, called the AdultsQLTM 3.0 Sickle Cell Disease Module, measures~     quality of life. The investigators will also see how hydroxyurea changes laboratory test~     numbers, and blood thickness.~   "
70777|NCT02640560|"~     In Italy, few data about anaphylaxis due to peanuts in pediatric age are available,~     conversely data about walnuts/hazelnuts, shellfish/mollusks anaphylaxis have not yet been~     collected.~      Children with physician-confirmed food allergy to peanuts, walnuts/hazelnuts and~     shellfish/mollusks will be recruited from 9 allergy clinics located in the Italian Territory~     (Bologna, Lecce, Napoli, Palermo, Parma, Pavia, Roma, Torino, Trento).~      Parent of food allergic children will compile a food allergy questionnaire (questions about~     general information on the family, on life and food habits, on indoor environment, on health~     status, on clinical aspects of the allergy, on the access to diagnostic and treatment~     resources).~      Parent of healthy children will compile a control questionnaire (questions about general~     information on the family, on life and food habits and on indoor environment) The 1-year~     survey will determine the frequency of anaphylaxis in allergic outpatient children.~   "
70778|NCT02640547|"~     This study seeks to provide evidence of the effectiveness and obtain patient reported~     outcomes (PRO) and work productivity data of the interferon-free regimen of Paritaprevir~     (PTV)/ritonavir (r) + Ombitasvir (OBV), +/- Dasabuvir (DSV), +/- Ribavirin in chronic~     hepatitis C virus infected participants.~   "
70779|NCT02640534|"~     The purpose of this trial is to test if the combination of enzalutamide and metformin in~     patients with castration resistant prostate cancer CRPC progressing on androgen deprivation~     therapy ADT is more effective compared to enzalutamide alone. The half of the patients will~     receive the experimental treatment combination, enzalutamide and metformin, while the other~     half will receive enzalutamide alone.~   "
70780|NCT02640521|"~     The overall goal of this study is to adapt and preliminarily validate an intervention based~     on evidence based approaches to assist smoking parents and other family members of inner-city~     children ages 4 to 12 with asthma to stop smoking.This study aims (1) to adapt existing~     guideline-based materials used in adult medicine to create a system- and provider-level~     intervention for pediatrics and (2) to evaluate feasibility and acceptability of (a)~     procedures to recruit inner-city, ethnic minority parents and (b) intervention procedures,~     and to estimate intervention effects.~   "
70781|NCT02640508|"~     The overall purpose of this study is to determine the overall response rate, efficacy and~     safety of the combination of eribulin and Lenvatinib.~   "
70782|NCT02640495|"~     The spread of artemisinin resistant falciparum malaria presents new challenges to both the~     control and treatment of malaria. Loss of ring stage susceptibility to the artemisinins might~     jeopardize the use of parenteral artesunate as the first line drug for the treatment of~     severe falciparum malaria.~      The purpose of this study is to assess the effect of artemisinin resistance (defined by a~     Kelch13 mutation with known functional significance) in P. falciparum malaria requiring~     parenteral artesunate treatment on lactate clearance parameters.~   "
70783|NCT02640482|"~     The purpose of this study is to evaluate the safety and efficacy of ABT-493/ABT-530 in adults~     with genotype 2 chronic hepatitis C virus (HCV) infection.~   "
70784|NCT02640469|"~     Currently at NYU institutions, providine-iodine and chlorhexidine medicated soaps are~     available as hand disinfection options. The purpose of this study is to determine the~     relative efficacy of traditional hand scrubs with chlorhexidine with or without rinsing with~     water after scrubbing is complete versus dry hand rubs with alcohol.~   "
70901|NCT02638935|"~     The primary aim of this study is to evaluate if VTIQ in addition to BI-RADS® categorization~     can improve the diagnostic accuracy with respect to detection of malignancies, in particular~     for BI-RADS® categories 3 and 4a. The idea of the study is to restage all patients in~     categories 3 and 4a according to a predefined VTIQ cut-off value of ≥ 3.5 m/s (37 kPa).~   "
70785|NCT02640456|"~     The aims of the study are:~        1. Explore the bacteriology of para- and retropharyngeal abscess.~        2. Validate the bacterial findings by exploring antibody development against F.~          necrophorum, F. nucleatum and S. pyogenes.~        3. Compare bacteriologic findings in concomitant peritonsillar and parapharyngeal~          abscesses.~        4. Characterize patients with para- and retropharyngeal abscess.~        5. Compare the concentration of amylase in para- and retropharyngeal abscesses and neck~          abscesses without relation to the pharynx or salivary glands.~        6. Perform gene-sequencing of F. Necrophorum strains, and compare these with strains~          recovered from patients with acute tonsillitis, peritonsillar abscess, and Lemierre´s~          syndrome.~   "
70786|NCT02640443|"~     The investigators will evaluate whether sulfamethoxazole, a sulfamide antibiotic, improves~     the symptoms of primary PREPL deficiency (hypotonia-cystinuria syndrome and isolated PREPL~     deficiency).~   "
70787|NCT02640430|"~     BACKGROUND: Studies have shown that COPD patients with bronchial hypersecretion have~     increased risk of acute exacerbations. FREE ASPIRE is an electro-medical device which removes~     bronchopulmonary secretions noninvasively, without using a suction catheter and without~     generating airway pressure.~      AIM: To compare FREE ASPIRE activity with the traditional treatment using PEP-bottle in the~     clearance of bronchial secretions in COPD patients METHODS: Forty severe and very severe COPD~     patients with mucus and reduced cough will be evaluated. Group comparison will be made~     between Intervention group using VAKÜM system (Free Aspire®), and Control group using~     traditional treatment with PEP-bottle over 10 daily sessions (20 minutes twice a day).~     Primary outcomes are changes in arterial blood gases exchanges, in perceived dyspnea and in~     symptom of bronchial encumbrance.~      EXPECTED RESULTS: A higher significant reduction of the perceived dyspnea and of perceived~     bronchial encumbrance is supposed in the Intervention group. Additional benefits among the~     secondary outcomes are also hypothesized in the same group.~   "
70788|NCT02640417|"~     This is a double-blind, randomized study in parallel groups of subjects presenting with low~     back pain. Randomized subjects will receive treatment for 60 days with either a combination~     of nucleotides and vitamin B12 or vitamin B1+B6+B12.~   "
70789|NCT02640404|"~     The aim of the study is to assess the safety of Menactra vaccine in infants, toddlers,~     children, adolescents, and adults~      Objective:~        -  To describe the safety profile after each and any dose (when applicable) of Menactra~          vaccine in participants aged 9 months to 55 years for registration.~   "
70790|NCT02640391|"~     The purpose of this study is to determine whether fecal calprotectin, fecal immunochemical~     test, and Rome III criteria for irritable bowel syndrome (IBS) can predict mucosal healing in~     patients with quiescent ulcerative colitis (UC).~   "
70791|NCT02640378|"~     Purpose of study is to obtain data on urinary HCG concentrations at >9 weeks of gestation.~   "
70792|NCT02640365|"~     MM-398 (also known as PEP02) is nanoliposomal encapsulated irinotecan: the liposomal~     formulation is designed to extend plasma circulation and to increase accumulation in the~     tumor through the enhanced permeability and retention (EPR) effect.~      This study introduces a new concept of combining free and nanoliposomal drugs.~   "
70793|NCT02640352|"~     The aim of the present study is to test the efficacy of the combination of two probiotic~     bacteria in reducing the severity of upper respiratory tract infections (common cold) in~     healthy children attending day care or school. The probiotic bacteria used are Lactobacillus~     plantarum strain DSM 15312 and Lactobacillus paracasei DSM 13434 at a total dose of 1 x 10^9~     CFU/tablet and day and will be consumed for a period of 12 weeks.~   "
70794|NCT02640339|"~     -  To determine whether retinal abnormalities, as measured by high definition optical~          coherence tomography (HD-OCT) and visual electrophysiology techniques can be used as a~          clinical biomarker to monitor disease progression overtime in patients with Parkinson~          disease.~        -  To establish whether these measures can be used to identify patients with PD in the~          premotor phase.~        -  To define the rate of progression of retinal abnormalities in PD (both in the motor and~          premotor stages) for potential use as a clinical outcome measure~   "
70795|NCT02640326|"~     It is common practice to insert a Foley catheter into the bladder to drain urine during and~     after a lung resection. Recently, there has been increasing interest in the potential risks~     associated with this catheterization, particularly with regard to infection. As thoracic~     surgery adopts minimally invasive surgical techniques, the need for urinary catheterization~     during surgery is being questioned since these less invasive surgeries are known to result in~     less post-operative acute pain, shorter length of stay, and other outcomes that tend to~     decrease overall anesthetic needs for this patient population. Thus, there is a need to~     investigate whether patients who have had a minimally invasive lung resection truly need the~     Foley catheter at all. This will be achieved by assigning patients to either an experimental~     no-catheter group or the standard of care routine urinary catheter group to determine if~     patients with no catheter experience different rates of complications. This pilot study will~     primarily determine if there is a difference in post operative urinary complications between~     the groups. It is hoped that this study will definitively determine whether a Foley urine~     catheter is a necessary procedure in the course of a minimally invasive lung resection.~   "
70796|NCT02640313|"~     Accumulating data in the literature suggests that radiolabeled-choline (18F-choline) is a~     sensitive molecular tracer for PET imaging that is taken up in activated cells and, as such,~     is able to identify active inflammatory sites. The investigators hypothesize that 18F-choline~     is also highly taken up in vulnerable plaques in comparison to the stable ones.~   "
70797|NCT02640300|"~     Clozapine has been demonstrated to be clinically superior to other antipsychotics in~     treatment-resistant schizophrenia (TRS), and is positioned as such in treatment guidelines.~     Because it is relegated to use in TRS, guidelines require that it only be used after other~     antipsychotics have failed; accordingly, clinicians routinely contend with stopping the~     previous antipsychotic in making the switch to clozapine. Perhaps because of its numerous and~     potentially severe side effects, the issue of clozapine titration has frequently been~     addressed, although to our knowledge no study has, as of yet, assessed the comparability of~     gradual vs. immediate antipsychotic discontinuation in switching to clozapine. To address the~     gap in knowledge specific to clozapine, the investigators conducted a pilot, 8-week,~     double-blind, randomized controlled trial examining immediate vs. gradual antipsychotic~     discontinuation in patients with schizophrenia undergoing a switch to clozapine.~   "
70798|NCT02640287|"~     Waldenström's macroglobulinemia is a rare disease whose pathophysiology remains at present~     poorly understood, although a recurrent mutation (L265P MYD88) has recently been described.~     Unlike other lymphoproliferative disorders, there is a defect in isotype switching, mechanism~     involving AID and NHEJ complex. Using a two-dimensional electrophoresis technology, our group~     showed that MW had a specific proteomic profile, and one of the differentially expressed~     proteins is Ku70 (encoded by XRCC6 belonging to NHEJ complex) .~      The investigators purpose to explore the mechanisms of underexpression of Ku70/XRCC6 (genetic~     or epigenetic modification) in comparison with other lymphoid malignancies and normal B~     cells.~   "
70799|NCT02640274|"~     The European guidelines of cardiovascular disease prevention recommend treatment modalities,~     such as lifestyle changes in order to minimize the risk of further cardiac event after a~     myocardial infarction (MI). However, a considerable gap exists between guidelines and their~     implementation in clinical practise. Further, less is known about the impact of different~     interventions on patient's knowledge, skills and confidence necessary for self-management~     after MI.~      Aim: To evaluate and compare the short- and long-term effects of an individual nurse-led~     counselling programme together with usual care for patients early discharged after MI on~     self-management behaviour.~   "
70800|NCT02640261|"~     The objective of our observational prospective study will be to compare, for women treated~     for infertility and included in a ICSI program, the implantation rate and delivery rate~     obtained after the transfer of a single blastocyst , chosen in a group of patients on the~     basis of the embryo morphology and in the other group on the basis of both embryo morphology~     and follicular fluid cytokines content.~      100 IVF infertile patients , aged 32-39 years, with normal ovarian reserve, previously~     stimulated for their first cycle with standard short protocol (GnRH-Ant) and r-FSH alone, who~     have had a low ovarian response, Fort < 50% ( FORT Criteria, 2012; FORT= PFCX100/AFC), will~     be treated for the second cycle with standard short protocol (GnRH-Ant) and r-FSH plus r-LH ,~     according to the standard established by our clinical practice.~      Patients will be part of one of the following groups:~      Group 1: single embryo transfer on day 5, according to standard embryo morphological criteria~     Group 2: single embryo transfer on day 5, chosen on the basis of both embryo morphological~     criteria and levels of cytokines measured in the individual FF.~   "
70801|NCT02640248|"~     The investigators have devised a simple method to continuously measure the CP using an~     invasive pressure monitoring setup (IPMS), which is used routinely in the operating room to~     monitor arterial or central venous pressures. The investigators have previously confirmed~     both in vitro and in vivo (previous IRB approved protocol), a clinically applicable agreement~     of the IPMS readings with the values obtained from a standard manometer (gold standard). In~     the current study, we will prospectively evaluate the relationship between the patient's head~     position and CP in patients undergoing otolaryngological surgery and also measure the oxygen~     concentration in the oropharynx to determine the potential risk of an airway fire.~   "
70802|NCT02640235|"~     The study is to evaluate the effectiveness and safety of CELSTAT vs active control.~   "
70803|NCT02640222|"~     The purpose of this study is to evaluate the APIXABAN use in the Prevention of Stroke and~     Systemic Embolism in Patients with Atrial Fibrillation in Real-Life Setting in France, data~     from SNIIRAM (French data base).~   "
70804|NCT02640209|"~     Open-label pilot study to determine safety and efficacy of CART-19 cells in combination with~     ibrutinib. The target dose will be 1-5x10xE8 CART-19 transduced cells administered via split~     dosing: 10% on Day 1, 30% on Day 2, 60% on Day 3. 15 evaluable subjects (adults) with~     relapsed or refractory CLL/SLL who have achieved partial response or stable disease on~     ibrutinib therapy will be eligible to receive CART-19 therapy.~   "
70805|NCT02640196|"~     The investigators hypothesized that the use of the King Vision™ and the Airtraq® VL would~     reduce the time to DLT intubation compared with the GlideScope® and Macintosh in simulated~     easy and difficult airways. The investigators have considered to assess the efficacy of each~     device in manikins before considering to evaluate them in patients undergoing thoracic~     procedures.~      Twenty-one staff anaesthesiologists who had limited prior experience in using the VLs for DLT~     intubation participated in this randomised crossover study. Following a brief demonstration~     and two practice attempts, participants were volunteered to insert a DLT using the Macintosh,~     GlideScope®, Airtraq®, and King Vision™ on two high-fidelity easy and difficult airway~     simulators in a computer-generated randomized sequence. The primary endpoint, time to DLT~     intubation, as well as, the views obtained at laryngoscopy, ease of intubation, numbers of~     laryngoscopy attempts and optimisation manoeuvers, and failure to intubation; defined as an~     attempt took longer than 150 seconds, were recorded.~   "
70806|NCT02640183|"~     The aim of this study is to investigate the efficacy of 5% lidocaine 25 mg-prilocaine 25 mg/g~     cream (EMLA®) applied to the uterine cervix for reducing pain during diagnostic hysteroscopy,~     using a visual analogue scale (VAS) for pain, and whether it can replace general anesthesia~     that may be required for some cases of office hysteroscopy.~   "
70807|NCT02640170|"~     The purpose of this registry is to monitor the rate of recurrence in patients who undergo~     cancer surgery.~   "
70808|NCT02640157|"~     The purpose of this study was to compare the safety and efficacy of ABT-493/ABT-530 to the~     combination of sofosbuvir (SOF) and daclatasvir (DCV) in adults with genotype 3 (GT3) chronic~     hepatitis C virus (HCV) infection.~   "
70809|NCT02640144|"~     This is a prospective, double blind randomized controlled trial. In this study we will~     investigate the influence of hyaluronic acid injection to knee after knee arthroscopy, when~     known or discovered cartilage damage greater than International Cartilage Research Society~     score (ICRS) grade 2 is found. The indication for arthroscopy is not necessarily the~     cartilage damage. A set of 3 consecutive injections will be administered and follow up of~     physical examination and questionaries will be done.~      Our null hypothesis is that the administration of hyaluronic acid will show decrease pain and~     quicker rehabilitation and return to normal activity in patients with grade 2 and higher~     cartilage damage that had gone through knee arthroscopy.~   "
70939|NCT02638428|"~     The purpose of this study is to evaluate the efficacy and feasibility of combination~     chemotherapy with target agents according to the result of targeted deep sequencing in~     pediatric patients with relapsed/refractory solid tumor or AML.~   "
70940|NCT02638415|"~     The purpose of the study is to compare the effect of HVPG-guided individualized therapy and~     non-HVPG guided traditional therapy in cirrhotic patients for secondary prophylaxis.~   "
70810|NCT02640131|"~     The burden of sexual dysfunction after prostate cancer surgery is responsible for the single~     greatest impact on patient/partner health-related quality of life; substantially more so than~     concern for cancer recurrence, or any other post-surgery side-effect. Consequently, there is~     a great need for progressive and distributable sexual health rehabilitation interventions~     designed to uphold intimacy and optimal sexual health. If the biomedical-psychosocial~     intervention is ultimately found beneficial, it will result in: 1) an empirically-based~     intervention that helps patients/partners maintain optimal health-related quality of life~     after prostate cancer surgery, and 2) a highly structured protocol and manualized~     intervention that is translatable to other treatment groups (e.g. radiation therapy) and~     University/Community-based hospitals.~   "
70811|NCT02640118|"~     Postprandial glucose (PPG) excursions are not only determined by insulin-mediated glucose~     disposal and endogenous glucose production (regulated by insulin and glucagon); also the rate~     of gastric emptying constitutes an important determinant of PPG levels 1. The short-acting~     glucagon-like peptide-1 (GLP-1) receptor agonist lixisenatide is used in the treatment of~     type 2 diabetes. It increases glucose-dependent insulin secretion, suppresses glucagon~     secretion and reduces gastric emptying of meals 2. These three mechanisms most likely~     constitute the weightiest mechanisms behind the potent impact of lixisenatide on exaggerated~     PPG excursions in patients with type 2 diabetes - which often are normalised during~     lixisenatide treatment 3. However, the separate impact of lixisenatide-induced reduction of~     gastric emptying (independently of the pancreatic effects) has been difficult to determine.~     Importantly, treatment with lixisenatide also decreases appetite and food intake and may,~     like native GLP-1, increase energy expenditure 4. So far an exact demarcation of the~     pancreatic and extrapancreatic effects of lixisenatide in humans remains to be established.~      The present project serves to determine whether effects of lixisenatide on gastric emptying,~     appetite, food intake and resting energy expenditure are dependent on the endocrine pancreas.~      The study is a randomised, placebo-controlled, double-blinded, cross-over study.~      12 healthy persons and 12 pancreatectomized patients (i.e. patients who have had their~     pancreata removed due to pancreatic cancer or severe chronic pancreatitis) will be subjected~     to two experimental days on which they will undergo a liquid meal test followed by a fasting~     period and finished off with an ad libitum meal with lixisenatide and placebo, respectively.~   "
70812|NCT02640105|"~     Cluster headache (CH) is one of the most painful primitive headaches. Developments in~     neuroimaging have demonstrated activation of the ipsilateral hypothalamic and orexinergic~     system, which is similar in patients with addictions. CH has strong links to the vascular~     system but there is no study measuring endothelial function in CH sufferers.~   "
70813|NCT02640092|"~     This is an open-label, longitudinal observational study evaluating the imaging~     characteristics of the tau positron-emission tomography (PET) radioligand [18F] Genentech Tau~     Probe 1 (GTP1) in the brain of participants with prodromal, mild, and moderate Alzheimer's~     disease (AD) compared to healthy participants. The overall goal of this protocol is to~     evaluate the longitudinal change in tau burden using [18F]GTP1, a tau targeted~     radiopharmaceutical.~   "
70814|NCT02640079|"~     The purpose of this study is to test the feasibility and efficacy of a brief group therapy~     treatment program focused on reducing pain catastrophizing in adolescents and young adults~     (ages 16-25) with menstrual pain.~   "
70815|NCT02640066|"~     Acute viral respiratory infections are among the most common causes of hospitalization in the~     pediatric population. The usual presentation of viral respiratory tract infections (VRTI)~     includes fever, malaise, wheezing and or coughing, rhinorrhea and loss of appetite. Up to 50%~     of children will have at least one viral-induced wheezing illness by school age. Currently~     treatment of VRTI is essentially supportive and no specific and efficient treatments are~     known. Given the lack of effective medications, current treatment for severe viral lower~     respiratory tract infection (LRTI) in infants relies on supportive measures only. These~     measures include supplementation of oxygen, monitoring of apnea, nasal/gastric tube feeding~     or intravenous fluids, and, if required, respiratory support with nasal bi-level~     positive-airway pressure. VTRI therefore represent an important unmet need for improved~     treatment strategies. Acupuncture's effect on has also been studied. Acupuncture has been~     shown to be a safe and effective in various respiratory tract inflammations. A review~     published in 2011 have found that acupuncture is safe for pediatric patients. Acupuncture's~     effect on acute viral induced wheezing and cough in hospitalized children has yet to be~     studied. Since the current standard of care is supportive care only, using acupuncture as an~     additional treatment may provide benefit in reducing wheezing, respiratory distress, and~     shorten hospitalization.~   "
70816|NCT02640053|"~     This randomized pilot clinical trial studies topical cryotherapy (cooling hands and feet with~     ice bags) in reducing pain in patients with chemotherapy induced peripheral neuropathy or~     paclitaxel induced acute pain syndrome. Peripheral neuropathy is a nerve problem that causes~     pain, numbness, tingling, swelling, or muscle weakness in different parts of the body.~     Paclitaxel produces a disabling syndrome of acute aches and pains. Topical cryotherapy is~     being studied to see if it can help relieve pain from peripheral neuropathy or acute pain~     syndrome caused by chemotherapy.~   "
70817|NCT02640040|"~     The study aims to evaluate the clinical result of Combined Surgery in Management of~     Congenital Pseudarthrosis.~   "
70837|NCT02639767|"~     The purpose of this study is to evaluate the safety of combining chemotherapy at different~     doses with a specific type of radiation therapy delivered to the entire lining of the lung to~     find out what effects, if any, it has on people. This radiation technique is called pleural~     intensity modulated radiation therapy (IMRT). IMRT specifically targets the lining of the~     lung (pleura) where the cancer is and reduces the risk of damaging the lung itself. When~     given after chemotherapy, pleural IMRT has demonstrated promising results with respect to~     keeping mesothelioma under control longer. However, the investigators want to determine if~     giving pleural IMRT at the same time as chemotherapy is safe. If safe, further studies will~     be done to see if chemotherapy and pleural IMRT given at the same time keeps the tumor under~     control for a longer period of time than chemotherapy followed by pleural IMRT.~   "
70941|NCT02638402|"~     To clarify the critical role of glycosyltransferases, altered Mucins, and RTKs in human~     ovarian and endometrial neoplasms, the study will examine the immunohistochemical expression~     profiles of glycosyltransferases, Mucins and receptor tyrosin kinases (RTKs) family in~     various stages and/or histologic subtypes of human ovarian and endometrial neoplasms and~     tissue microarrays.~   "
70818|NCT02640027|"~     Fractures of the supracondylar region of the humerus are among the most common pediatric~     injuries requiring the attention of an orthopaedic surgeon. Children with non-displaced~     fractures (Type I), as well as those with history of elbow trauma, have been traditionally~     managed with non-surgical immobilization. Recently published clinical guidelines support such~     practice, based on the result of two prospective studies in which either collar and cuff or~     posterior splint immobilization were used. When compared to collar and cuff immobilization,~     posterior splints resulted in better pain relief within the first two weeks of injury;~     however, critical outcomes, including the incidence of cubitus varus, hyperextension, and~     loss of reduction, were not reported.~      While posterior splints appear to be an attractive option for the treatment of non-displaced~     pediatric elbow fractures, a recent retrospective analysis on the use of posterior splints~     for the treatment of such injuries reported a small proportion of fractures demonstrating~     displacement. The potential for non-compliance with the use of removable devices, especially~     in the older pediatric population, is also a concern.~      The use of a removable immobilization that can reliably maintain fracture alignment, minimize~     the risk of non-compliance, and result in similar outcomes as those obtained with regular~     casting could be advantageous: It appears that such immobilization could be removed easily~     and safely at home, potentially resulting in a lower number of patient visits, decreased~     health-care costs, and higher patient/parent satisfaction.~      Telemedicine, defined as the use of telecommunication and information technologies in order~     to provide clinical health care at a distance, has been seldom used in the field of pediatric~     orthopaedics. Commonly mentioned attributes of telemedicine include improved access to~     healthcare providers, cost containment and increased healthcare efficiency, quality care~     improvements related to patient satisfaction, and potential reduction in travel time for~     patients and families.~      The purpose of this randomized, controlled, prospective study is to assess telemedicine as a~     tool for the treatment follow-up of non-displaced SCHF fractures in children. Investigators~     hypothesize that using telemedicine will result in comparable clinical outcomes as those~     obtained in patients treated in a clinical facility, with increased patient satisfaction and~     decreased healthcare costs.~   "
70819|NCT02640014|"~     The outcomes of oral immunotherapy (OIT) in food allergy study will provide more knowledge of~     oral immunotherapy. So far the OIT has showed in clinical experiments to be a interesting way~     to increase the unresponsiveness in severe food allergies. However little is known about it´s~     long-term outcomes, immunological mechanisms and there are no previous studies about~     cost-utility of OIT.~   "
70820|NCT02640001|"~     In patients on mechanical ventilation, it is not known whether the identification of S.~     aureus in LRT samples improves the performance of its nasal detection.~      To assess the MSSA or MRSA carrier status of patients requiring mechanical ventilation for~     more than 48 hours after major heart surgery: comparing the performance of the diagnostic~     technique Xpert® SA Nasal Complete assay in nasal swab and LRT samples.~   "
70821|NCT02639988|"~     The purpose of this study is to determine whether patients with rheumatoid arthritis and type~     2 diabetes experience a more severe disease course compared to control patients with~     osteoarthritis and type 2 diabetes~   "
70822|NCT02639975|"~     The proposed trial a Randomized, Double Blind, Placebo Controlled first in-human Study to~     Assess the Safety and Tolerability of Single Ascending Oral Doses of PBF-677 in Male Healthy~     Volunteers (Protocol Code No:CUNFI-1509 EudraCT No:2015-003546-57) will be a single-centre,~     randomized, double-blind, dose escalation study without therapeutic benefit, in which PBF-677~     will be administered as single, oral, ascending-dose to volunteers.~      Up to four different rising doses (100 mg, 200 mg, 400 mg and 600 mg) will be tested in~     groups of 8 participants; in each dose level participants will be randomized to active drug~     or placebo in a 6:2 fashion. As this will be the first time that PBF-677 in going to be~     administered to humans, as a safety measure a stepwise drug administration will be performed~     in each cohort. The volunteers of each cohort will be divided in 3 blocks/subgroups:~     Initially, one volunteer will receive active drug (subgroup 1). After 48h of safety and~     tolerability assessment, a second subgroup of 3 volunteers will receive 2 active drug and 1~     placebo and after further 48h of safety and tolerability assessments a third subgroup of 4~     volunteers will receive 3 active drug and 1 placebo. After evaluation of safety, parameters~     of corresponding dose level the process will replicate one week afterwards in the following~     dosages.~      The principal variable safety and tolerability of PBF-677 will be evaluated with physical~     records (Electrocardiogram (ECG), vital signs, blood chemistry and haematology, conducted~     before, during and after study course). Assessment of the pharmacokinetic profile (Maximum~     plasma concentration of the drug (peak) after single dose (Cmax),Time necessary to reach Cmax~     (tmax), Area under the time-concentration curve to zero to time t (AUC0t), and~     Elimination half-life (t1/2) of PBF-677 will be included as secondary variable.~   "
70823|NCT02639962|"~     Identifying patients who are at risk for a future myocardial infarction, is still one of the~     biggest challenges in cardiology.~      In this study the investigators will investigate culprit lesion in patients with NSTEMI and~     the ability of cardiac CT with dual energy computed tomography (DECT) scanning to describe~     and identify plaques that may be vulnerable. The investigators will also describe changes in~     characteristic in both stable and unstable plaques during 1 year follow up of NSTEMI and a~     matching group of stable angina pectoris (SAP) patients.~   "
70824|NCT02639949|"~     Nonadherence to medication is a major obstacle to successful treatment of renal transplant~     patients. This study has two primary aims. The first is to test whether a culturally~     sensitive cognitive-behavioral adherence promotion program could significantly improve~     medication adherence to tacrolimus prescription. Participants will be randomly assigned to~     either group CBT or to standard care. The second aim is to pilot a novel strategy of~     adherence measurement - unannounced telephone pill counts, which has been shown to be a valid~     and reliable means to measure medication adherence in other patient populations. Participants~     will be recruited from waiting area of the kidney transplant clinic at SUNY Downstate Medical~     Center in Brooklyn, NY. Three unannounced telephone pill counts will be conducted prior to~     start of the intervention in order to establish baseline adherence and three pill counts will~     be conducted post-intervention. Tacrolimus trough concentration levels will also be collected~     as an additional biological measure of adherence.~   "
70825|NCT02639936|"~     Evaluation of a new ELISA based interferon-gamma release assay (QuantiFERON TB plus In-tube~     test) in immunocompromized patients~   "
70826|NCT02639923|"~     The aim of this study is to investigate the early serum measurement (<6h after injury) of~     mRNA miR Let-7i, miR-16 and miR-92 in patients with MHI and intracranial traumatic lesions~     (CCT pos.) as compared to those in patients with MHI without intracranial traumatic lesions~     (CCT neg.).~      S100B serum levels will be measured in both groups. The usual risk factors for the occurrence~     of an intracranial hematoma (diagnostic algorithm) will be recorded. Additionally, a group of~     healthy individuals will serve as a control group.~   "
70827|NCT02639910|"~     This is a two-cohort, multicenter, open-label study of MOR00208 combined with idelalisib or~     venetoclax in adult patients with R/R CLL or R/R SLL pretreated with a BTK inhibitor (e.g.,~     ibrutinib) as single agent or as part of combination therapy.~   "
70838|NCT02639754|"~     Young men who have sex with men (MSM) in low- and middle-income countries often do not seek~     out HIV testing, are unaware of their HIV-positive status, and do not receive early medical~     care, compromising their health and contributing to downstream disease incidence. This~     situation is of great concern in post-socialist countries of Eastern Europe, where stigma~     about HIV/AIDS and same-sex behavior are great, HIV epidemics are still increasing, and the~     health needs of young MSM are rarely acknowledged or addressed. The planned research will be~     conducted in Sofia, Bulgaria, where MSM account for nearly half of HIV infections. The study~     will be conducted in two phases.~   "
70828|NCT02639897|"~     Direct laryngoscopy and intubation is an essential initial aspect of airway access during~     general anesthesia. To perform the procedure effectively, it requires adequate mouth opening,~     head and neck movement, and a normal temporo-mandibular joint mobility. Any issue with the~     above three results in a compromised upper airway at the outset and the condition is known as~     anticipated difficult airway, i.e. an airway that is difficult to access with conventional~     laryngoscopy and intubation methods. To overcome the difficulty, either one has to resort to~     newer advanced technique and equipment or the available conventional technique needs to be~     refined and modified to suit the requirement. While the former requires extraordinary~     expertise and finances, an option difficult to achieve in developing countries; the latter~     warrants focused interest to develop alternative approach with the same set of equipments.~      Since submucous fibrosis and the associated restricted mouth opening have taken the~     proposition of an epidemic owing to widespread use of betel nut and tobacco; these patients,~     when requiring surgery, are difficult candidates for GA and airway control. The fact that,~     when they arrive as pre-surgical candidates, they have variable degree of mouth opening~     restriction, which if approached with a strategy, may be amenable to conventional control of~     airway. If investigators paint all the patients with mouth restriction as difficult airway,~     it will result in uncalled surgical, economic, health system and psychological burden.~     Therefore, it is prudent to undertake research relating to refinement of airway access~     techniques with the easily available, cheap and user- friendly equipment (conventional~     laryngoscope), such that a proportion of above stated burden can be reduced.~      In view of the above, investigators plan to undertake a study to enhance our working~     knowledge with a conventional laryngoscope (Macintosh) to facilitate ways to control the~     airway difficulty secondary to mouth opening restriction. Investigators believe that the~     prospective knowledge thus generated would help us identify whether there is a feasibility of~     conventional airway management or an alternative advanced access technique is needed in the~     first place. This will prevent undue cancellations, delayed surgeries, and patient morbidity.~   "
70829|NCT02639871|"~     There is no curative treatment available today in Huntington disease (HD) despite the~     identification of the mutated gene 20 years ago. Nonetheless, safe and promising therapeutic~     strategies targeting brain energy metabolism are now becoming available.~      In view of the small effect sizes of any clinical parameter in HD, robust neuroimaging~     biomarkers reflecting brain energy metabolism are therefore urgently needed to better assess~     the potential of therapeutics targeting the mitochondria, and especially the Krebs cycle.~     Identifying such biomarkers at the presymptomatic phase in HD also provides a unique window~     for therapeutic intervention, which can be used as a proof-of-concept for the real challenge~     of tomorrow's medicine: the prevention of neurodegeneration HDeNERGY is an observational~     study consisting of the transfer of methods from preclinical to clinical studies and their~     application in HD. HDeNERGY aim at optimizing MRI/MRS methods to study the dynamics of brain~     energy metabolism. At the CENIR (Centre de neuro-imagerie et de recherche, Paris) the~     determination of creatine kinase rate will be first validated in healthy volunteers (n=20)~     and then applied to the selected cohort of early affected HD patients (n=20), presymptomatic~     individuals (n=20) and controls (n=20) together with the methods previously validated in HD~     patients (Mochel et al., 2012b) to determine the ratio of inorganic phosphate (Pi)/~     phosphocreatine (PCr) during visual stimulation in presymptomatic individuals. The Chemical~     Exchange Saturation Transfer (CEST) method on the 3T clinical scanner of CENIR will be first~     validated in healthy volunteers (n=20) and then applied to the selected cohort of early~     affected HD patients (n=20), presymptomatic individuals (n=20) and controls (n=20).~      The cerebral synthesis rate of creatine phosphate and of brain glutamate concentrations and~     pH values will be compared between controls, HD patients and HD presymptomatic individuals,~     and correlated with clinical parameters (age, BMI, UHDRS).~   "
70830|NCT02639858|"~     A phase II study to evaluate the efficacy and safety of Docetaxel-PM in recurrent or~     metastatic head and neck squamous cell carcinoma~   "
70831|NCT02639845|"~     The purpose of this study is to determine if an eye drop video monitoring device can~     accurately assess (as compared to a patient's own log or a proprietary software) the exact~     amount and time of eye drop delivery to a patient's eye. It is our belief that the~     experimental device will help patients to be more compliant by: 1) providing a viewable~     format so patients can see what is happening when they are applying their drops 2) providing~     greater accuracy to doctors regarding when and how much medication was used 3) providing~     greater accuracy to doctors and patients regarding how much medication was actually delivered~     to a patients eye.~   "
70832|NCT02639832|"~     The purpose of this research study is:~        -  To test blood for the presence of tumor derived circulating tumor cells (CTCs) or~          circulating tumor DNA (ctDNA) using an investigational medical device called the~          LiquidBiopsy®. Using the LiquidBiopsy® platform, recovered cells or DNA can also be~          investigated to obtain genetic information that may be useful to treating physicians in~          understanding disease.~        -  To test blood for natural killer cells (NK cells), which are part of the body's natural~          immune defense against tumors. A device called the NK VueTM Kit will be used for this~          test.~      The LiquidBiopsy® is a new investigational device. An investigational device is one that is~     not approved by the United States Food and Drug Administration (FDA). The NK VueTM Kit is an~     investigational device in the United States but is approved in Canada and South Korea as a~     class II device.~      If a tumor is present, very tiny numbers of tumor cells or the contents of these tumor cells~     can get dislodged from the tumor and swept into the bloodstream. The LiquidBiopsy® device is~     able to purify the tiny numbers of tumor cells or ctDNA in the blood. Even if a tumor is too~     small to be found by other means such as an x-ray, it is possible that ctDNA or CTCs may be~     found in the blood. Genetic information can then be recovered from these cells or DNA to look~     for genetic changes that are related to the abnormal growth in a tumor. This will potentially~     allow researchers to study tumor cells or tumor DNA from a blood sample instead of a biopsy~     sample. This may influence cancer diagnosis, treatment and drug selection in the future.~      NK cells occur naturally in the body and kill tumor cells. This study will measure the~     activity of the NK cells in blood. A strong correlation between low NK cell activity and~     increased circulating tumor cells in blood has been reported.~   "
70833|NCT02639819|"~     This is single-arm, open-label, safety and feasibility pilot study of ɛ-aminocaproic acid in~     ICH patients.~      Consecutive ICH volume with hematoma volume less than 30 mL by ABC/2 method presenting within~     3 hours of symptom onset, meeting all inclusion criteria, and without exclusions will be~     consented and enrolled. Subjects will receive 5 grams of intravenous ɛ-aminocaproic acid over~     1 hour, followed by the same at 1 mg/hour for 23 hours. Comupted tomography (CT) head will be~     done at 24 hours in order to follow hematoma size. Electrocardiogram, lower extremity venous~     Doppler and NIHSS will also be done at 24 hours. The patient will be followed in the clinic~     30-90 days post discharge for functional status.~   "
70834|NCT02639806|"~     This study evaluates the outcomes of stroke patients treated for intravascular thrombectomy,~     using either a local anesthetic with sedation, or a general anesthetic. Historical data will~     be used for those treated with the local anesthetic, and prospective data will be used for~     those treated with the general anesthetic.~   "
70835|NCT02639793|"~     The study will assess the atrial fibrillation burden recorded By implantable loop recorder at~     12 and 24 months compared to baseline. The patients with clinical indication fo catheter~     ablation of paroxysmal atrial fibrillation will be randomized to three techniques: manual~     radiofrequency ablation, radiofrequency ablation using remote magnet monitoring, and~     cryoablation.~   "
70836|NCT02639780|"~     The investigators will define procoagulant properties of packed red blood cells and~     investigate whether packed red blood cells from certain donor populations are prone to induce~     procoagulant states.~   "
70839|NCT02639741|"~     The investigators designed a randomized double-blind placebo-controlled trial to evaluate the~     effect of preoperative single dose of oral melatonin and vitamin C administration on~     postoperative analgesia in patients undergoing elective major abdominal surgery.~   "
70942|NCT02638389|"~     The phosphatidylinositol 3-kinase (PI3Kinase)/Protein Kinase B (AKT)/mammalian target of~     rapamycin (mTor) pathway plays a role on the development and the venous/lymphatic vascular~     organisations.~      The investigators want to study the efficacy and the safety of Rapamycin, an mTor inhibitor.~   "
70840|NCT02639728|"~     The effects of coffee have been shown to act as a colonic stimulant. Caffeinated coffee~     stimulates colonic activity, most notably in the transverse/descending colon, in magnitude~     similar to a meal, 60% stronger than water, and 23% stronger than decaffeinated coffee. [1]~     Moreover, the consumption of both water and caffeine causes a decrease in the rectal sensory~     threshold for the desire to defecate, while anal sphincter pressure after caffeine intake is~     significantly higher than after water intake. This may result in an earlier desire to~     defecate. [2] Coffee has also been shown to have an effect on defecation by increasing rectal~     tone by 45% (measured with a barostat) thirty minutes after consumption. [3]~   "
70841|NCT02639715|"~     The aim of this observational study is to describe for the first time a complete set of~     morphometric and morphokinetic parameters of frozen-thawed human embryos in order to select~     the embryo with the highest implantation potential. These parameters will be correlated with~     (1) data of the fresh embryos and their subsequent survival, the evolution of the contact~     surfaces between surviving blastomeres and the resumption of mitosis; (2) patient~     characteristics and clinical outcome of frozen-thawed embryos and (3) a comparison between~     embryos cryopreserved with vitrification or the slow method regarding these parameters will~     be performed.~      This project aims to introduce new evaluation criteria of the frozen-thawed embryos to~     improve success rate of FET cycles. By establishing new precise, reliable and non-invasive~     measurable parameters, we aim to (1) select which supernumerary embryos are at chance to~     survive the freezing/thawing procedures, (2) establish cut off parameters for the survival~     rate of the embryo, (3) assess implantation, pregnancy and live birth rates depending on the~     developmental characteristics after thawing and after 24h of culture.~      Our strategy for improving the outcome of FET cycles is based on the study of morphometric~     and morphokinetic parameters in frozen-thawed embryos and the correlation with embryological,~     clinical and cycle parameters. Transferring a well-defined thawed embryo with a high~     implantation potential may lead towards an increase in the implantation and life birth rate~     and an increase in the cumulative live birth rate with a reduction of the IVF costs in order~     to optimize the health-economic situation of reproductive medicine.~   "
70842|NCT02639702|"~     Plasma half-life has routinely been used to establish the dosing schedule of antipsychotics;~     for example, it is recommended that agents with a short plasma half-life be administered~     multiple times per day. However, to date, several randomized controlled trials (RCTs) have~     shown no differences in clinical outcomes between once- and twice-daily dosing of various~     antipsychotics, suggesting that once-daily dosing of antipsychotics is a viable option~     regardless of plasma half-life. This would apply to clozapine as well; however, there have~     been no studies comparing once-daily vs. twice-daily dosing regimens of clozapine in terms of~     efficacy and tolerability. To address this gap in the literature, the investigators shall~     conduct a pilot, double-blind, RCT to examine efficacy and tolerability following a switch to~     once-daily dosing regimen of clozapine in patients with schizophrenia receiving clozapine~     twice a day.~   "
70843|NCT02639689|"~     Evaluation of the increase of the driving speed after apparatus by Walkaide® medical device~     in deficits levator foot of central origin.~   "
70844|NCT02639676|"~     Pregnant mothers who develop high blood pressure and other vascular problems (preeclampsia)~     deliver babies with increased neonatal health problems, which include lung disease and~     vascular complications, later in life. Investigators will evaluate whether infants of mothers~     with preeclampsia have evidence for impaired development of the lungs and blood vessels.~   "
70845|NCT02639663|"~     Leboride is a dental support device that was developed for reducing pain during active labor.~     It is made of an inert material, placed in the woman's mouth and does not disturb breathing,~     talking, or any other activity expected during labor. It is a single-use device, each user~     receives a new one.~      This study hypothesis is that the Leboride use can reduce pain during breastfeeding, by that~     improve women's breastfeeding experience, and increase breastfeeding rates.~   "
70846|NCT02639650|"~     This clinical trial is designed to study the effect and safety of paclitaxel plus cisplatin~     as the first-line regimen in the treatment of high risk gestational trophoblastic tumor.~   "
70847|NCT02639637|"~     The purpose of this study is to understand how dipeptidyl peptidase IV (DPP4) inhibition in~     diabetics affects hemodynamic parameters and sympathetic activation in the setting of~     increasing concentrations of neuropeptide Y, an endogenous peptide. The central hypothesis is~     that DPP4 inhibition decreases degradation of neuropeptide Y, resulting in increased~     vasoconstriction and sympathetic activation.~   "
70848|NCT02639624|"~     This is a non randomized crossover trial investigating whether changing the pattern of~     bicarbonate administration during hemodialysis will result in the more efficient filtration~     of highly protein bound solutes. The experimental group will be dialyzed with low bicarbonate~     dialysate for the first half of dialysis then switched over to normal bicarbonate dialysate~     for the second half. The control group will be dialyzed entirely with normal bicarbonate~     dialysate. The two groups will switch one week late and patients will serve as their own~     matched controls for a completely standard dialysis and one that is split into two halves~     with different bicarbonate concentrations.~   "
70849|NCT02639611|"~     The primary purpose of this study is to evaluate changes in shoulder tightness, chest~     tightness, and general pain related to post-mastectomy reconstructive surgery with tissue~     expansion in women who are randomized to receive acupuncture treatment immediately after~     surgery (twice a week for 6 weeks) compared to those who are randomized to no acupuncture~     treatment for 6 weeks, but offered acupuncture at the end of the 6 week study period.~   "
70850|NCT02639598|"~     Chronic migraine (CM) is a prevalent and devastating disorder with limited therapeutic~     options. This study explored the efficacy of 10 mg/day flunarizine for CM prophylaxis as~     compared with 50 mg/day topiramate.~   "
70851|NCT02639585|"~     We perform this study to identity efficacy and safety of Daclatasvir and Asunaprevir in real~     practice.~   "
70943|NCT02638376|"~     The objectives of this study are to evaluate the safety of and efficacy of the KXL system~     with vibeX Rapid (Riboflavin Ophthalmic Solution) for Corneal Collagen Cross-Linking in eyes~     having:~        1. Keratoconus (KC) ,~        2. Post LASIK ectasia (PLEc)~   "
70944|NCT02638363|"~     The aim of this study is to investigate the predictive value of emotion regulation and~     attentional control for outcome of Cognitive Behavioural Therapy for adults with anxiety~     disorders in a naturalistic setting.~   "
70852|NCT02639572|"~     Siloss® (Azurebio, Madrid, Spain) is a synthetic and inorganic bone graft material and is~     composed of a dicalcium phosphate anhydrous (monetite), hydroxyapatite (HA), and amorphous~     silica and trace amounts of zinc. It is manufactured by a proprietary process avoiding high~     temperatures. This results in a non-sintered material with a high specific surface area (65~     m2/g) and high interconnected porosity (60%) that favour a high degree of interaction with~     its biological surrounding. It is fully resorbable, being replaced by natural bone, thereby~     avoiding the disadvantages of nonresorbable materials that interfere with normal processes of~     bone remodelling. Siloss® is resorbed both by a dual process of slow dissolution of its~     components and by active cellular remodelling. Controlled dissolution of Siloss® releases Ca,~     P, Si and Zn that stimulate regeneration processes while larger pores are formed allowing~     colonization of osteoclasts and osteoblasts involved in bone remodelling. It functions as a~     bioactive temporary scaffold maintaining the desired volume while it promotes bone~     regeneration and is being replaced by new vascularized bone. The alloplastic property of the~     graft material avoids the risk of infection and adverse inflammatory reactions. Also,~     resorption of Siloss® prevents possible adverse effects associated with long permanence of~     low resorbable materials.~      The aim of the present study is to clinically and radiographically evaluate the efficacy of~     bone graft material (Siloss ®) in the treatment of intrabony defects.~   "
70853|NCT02639559|"~     Current protocols use G-CSF to mobilize hematopoietic progenitor cells from matched sibling~     and volunteer unrelated donors. Unfortunately, this process requires four to six days of~     G-CSF injection and can be associated with side effects, most notably bone pain and rarely~     splenic rupture. BL-8040 is given as a single SC injection, and collection of cells occurs on~     the same day as BL-8040 administration. This study will evaluate the safety and efficacy of~     this novel agent for hematopoietic progenitor cell mobilization and allogeneic~     transplantation based on the following hypotheses:~        -  Healthy HLA-matched donors receiving one injection of BL-8040 will mobilize sufficient~          CD34+ cells (at least 2.0 x 10^6 CD34+ cells/kg recipient weight) following no more than~          two leukapheresis collections to support a hematopoietic cell transplant.~        -  The hematopoietic cells mobilized by SC BL-8040 will be functional and will result in~          prompt and durable hematopoietic engraftment following transplantation into~          HLA-identical siblings with advanced hematological malignancies using various~          non-myeloablative and myeloablative conditioning regimens and regimens for routine GVHD~          prophylaxis.~        -  If these hypotheses 1 and 2 are confirmed after an interim safety analysis of the data,~          then the study will continue and include recruitment of haploidentical donors.~   "
70854|NCT02639546|"~     This open-label, dose-escalation study is designed to evaluate the safety, tolerability,~     pharmacokinetics, and preliminary efficacy of cobimetinib in pediatric and young adult~     participants with solid tumors with known or potential kinase pathway activation for which~     standard therapy has proven to be ineffective or intolerable or for which no curative~     standard-of-care treatment options exist. The study will be conducted in two stages: a~     dose-escalation stage and an expansion stage at the recommended dose.~   "
70855|NCT02639533|"~     Fibromyalgia syndrome represents a spectrum disorder characterized by widespread chronic~     pain, fatigue, sleep disturbances, mood and cognitive alterations. The most accepted models~     explaining the causes of the disease have focused on the reduced pain inhibitory systems~     activity, that allow low intensity stimuli to be processed easier, and that finally amplify~     pain stimuli. One of the interventions approved for Fibromyalgia is Pregabalin, which~     demonstrated to be effective reducing pain. Different studies in animals have shown that it~     works reducing the liberation of neuronal messengers, which slow the conduction of pain~     signals. Although studies in humans have confirmed Pregabalin clinical benefits, there are~     still few studies aiming to explain how it actually works in patients with fibromyalgia,~     though.~      A better understanding of the mechanisms by which Pregabalin reduces pain in patients with~     fibromyalgia would allow designing new interventions to enhance its clinical effects. Thus,~     the investigators propose to study in real-time the electrical, vascular and hormonal~     response of the brain of patients with fibromyalgia who receive a single dose of Pregabalin.~     The vascular response will be assessed using functional near infrared spectroscopy (fNIRS)~     neuroimaging techniques. The electrical response will be assessed using Transcranial Magnetic~     Stimulation (TMS). The hormonal response will be assessed in blood, measuring neurotrophins~     (Brain Derived Neurotrophic Factor) and inflammatory mediators (Tumor Necrosis Factor). These~     responses will be studied in consideration of the patients' characteristics that will be~     assessed using validated scales.~      Taken into account the above considerations, a crossover, double-blinded randomized clinical~     trial is proposed. In the investigators' study, patients and healthy volunteers will be asked~     to visit the investigators' laboratory in three opportunities: one for a baseline assessment,~     and the other two to test the effects of either Pregabalin 150 mg PO or Placebo. All~     participants will eventually receive both, Pregabalin and Placebo. In each visit a brain~     hemodynamic, electrical, hormonal and clinical evaluation will be performed.~   "
70856|NCT02639520|"~     To demonstrate non-inferiority of a non-antibiotic therapy with CLR versus an antibiotic~     treatment with fosfomycin trometamol in women suffering from acute lower uUTIs as measured by~     the proportion of patients who received an additional antibiotic treatment for acute lower~     uUTIs during the trial.~   "
70857|NCT02639507|"~     The purpose of this research is to evaluate the effectiveness of vitrectomy for the treatment~     of diabetic macular edema. Diabetes is known to cause retinal blood vessels to leak, leading~     to swelling of the central retina (macula), and decreased vision. Removing the vitreous gel~     with vitrectomy surgery is known to decrease the swelling caused by diabetes. Diabetic~     retinopathy is often treated with laser or injections of medicine in to the eye.~   "
70858|NCT02639494|"~     An evaluation of the feasibility of using the Self-Centering Guide Catheter to deliver a~     guide wire across a stenotic native aortic valve into the left ventricle.~   "
70859|NCT02639481|"~     Patients with acquired brain injury (ABI) often suffer from severe disorders of consciousness~     (DOC), such as coma, unresponsive wakefulness syndrome (UWS), or minimally conscious state~     (MCS). This study examines the effect, a novel robotic rehabilitation device (the Erigo®Pro~     system) has on the recovery of consciousness of DOC patients. The device enables patients to~     be verticalized very early during acute neurorehabilitation and includes robotic leg movement~     training as well as functional electrical stimulation (FES) of leg nerves. Patients will be~     randomly allocated to one of three treatment groups: (i) control group with standard~     physiotherapy without the device, (ii) device treatment without FES, and (iii) device~     treatment with FES. Time until recovery of consciousness, rehabilitation outcome, and amount~     of complications will be the outcome variables.~   "
70860|NCT02639468|"~     Evaluation of electrical impedance tomography to non-invasively monitor stroke volume when~     compared to reference measurements performed via right heart thermodilution~   "
84967|NCT02454842|"~     This phase 2 study is designed to evaluate the safety and activity of TH-4000 (Tarloxotinib),~     a hypoxia-activated prodrug, in patients with EGFR-Mutant, T790M-Negative, Advanced non-small~     cell lung cancer (NSCLC).~   "
70861|NCT02639455|"~     Poor oral health can greatly impact quality of life and can also impact overall health. For~     instance, research suggests that poor oral health may be associated with systemic diseases~     such as diabetes, heart disease, and stroke. Therefore, there is a need to investigate the~     causes of poor oral health.~      The idea that athletes may have a propensity for dental caries has been gaining traction.~     There have been recent reports of high levels of dental caries, dental erosion and~     periodontal diseases among elite soccer players compared to the general public and in~     athletes from a wide range of sports. However, to date, no studies have investigated the oral~     microbiome of athletes.~      Many factors affect the development of dental caries, including host factors, diet, and the~     microorganisms present in the oral cavity. More than 700 types of bacterial species have been~     detected in the oral cavity, and some have been identified to play a significant role in the~     development of oral disease. Streptococcus mutans is the main species involved in dental~     decay with various lactobacilli also involved in the disease process. Treponema denticola,~     Porphyromonas ginigivalis, and Aggregatibacter actinomycetemcomitans are the main species~     involved in periodontal disease. It is not currently known if changes in the collective oral~     microbiome foster or impede the development of these pathogens.~      Complex microbe-host interactions occur to allow for the progression of oral disease, with~     host nutrition and hygiene playing a significant role. Endurance athletes widely consume a~     variety of sport drinks, gels, and energy bars for supplementation of electrolytes and~     carbohydrates. The consumption of these foods leads to pH drops in the oral cavity and may~     contribute to tooth erosion and demineralization. Oral disease may also be exacerbated by the~     fluid and electrolyte deficit that impedes saliva flow during exercise. However, several~     studies have failed to demonstrate a clear link between sports drinks and an increased risk~     of dental caries among athletes.~      Dental caries are caused by microorganisms in the oral cavity. These microbes may be affected~     by host factors or nutrition in the progression of oral disease. Due to the documented~     prevalence of dental caries in athletes and the lack of clear connection between sports~     drinks and dental caries, the investigators propose to investigate any correlation that may~     exist between exercise and the oral microbiome.~   "
70862|NCT02639442|"~     The ProArc Medical ClearRing™ system is a prostatic reshaping device that is designed to~     treat Lower Urinary Tract Symptoms (LUTS) due to BPH.~      During the procedure an implant is delivered into the prostate tissue obstructing the urethra~     and restricting urine flow. The delivery system uses an electro-cutting blade to perform a~     circular and superficial incision, in which the implant is placed. Such an implant, with the~     shape of an open ring, expands the obstructed area, reducing the fluid obstruction through~     the prostatic urethra.~   "
70863|NCT02639429|"~     Obese pregnant women (BMI ≥ 30 kg/m2) are more likely than their normal-weight counterparts~     to require induction of labor because of increased rates of obstetric complications including~     pregnancy related hypertensive disorders, diabetes, and prolonged gestations. Several studies~     have shown that obese women experience increased labor duration and oxytocin needs when~     compared to normal-weight women. This in turn results in increased rates for unplanned~     cesarean delivery (CD) as a result of failed induction of labor (IOL), arrest disorders and~     non-reassuring fetal heart rate tracing, that is dose-dependent with increasing class of~     obesity. The investigators hypothesize that obese pregnant women and unfavorable cervix~     (Bishop score ≤ 6), IOL ≥ 24 weeks gestation using the Foley balloon plus vaginal misoprostol~     will result in reduced cesarean delivery rates when compared to vaginal misoprostol alone.~   "
70864|NCT02639416|"~     Children with complicated severe acute malnutrition (SAM), such as inability to take adequate~     feeds, infection and diarrhoea, require in-patient management. Despite following a~     well-established World Health Organisation (WHO) protocol, outcomes are poor. Case fatality~     often exceeds 20%. Amongst survivors discharged home, many subsequently die, have long-term~     poor growth or recurrence of SAM.~      It has long been recognized that children with SAM have intestinal inflammation and that this~     persists despite management according to WHO guidelines. The inflammation is thought to~     result from increased exposure to microbial pathogens in the gut in areas with poor~     sanitation. The damaged lining of the intestine impairs food digestion and absorption, likely~     allows gut bacteria to enter the blood stream to cause sepsis and also exposes the gut immune~     cells to microbial and food antigens causing the inflammation to persist. Failure to treat~     the intestinal inflammation is likely to contribute to the poor response to treatment and~     poor long-term outcomes in many children with SAM.~      The intestinal inflammation seen in SAM is very similar to that which occurs in food~     intolerance (e.g. intolerance to cow's milk protein) and inflammatory bowel disease. In these~     conditions, the inflammation is treated very effectively with hypoallergenic (elemental)~     and anti-inflammatory (polymeric) formulas. These are nutritionally complete feeds that~     have a similar composition to the feeds used for nutritional rehabilitation in SAM.~      We aim to undertake a pilot study to see if an elemental and/or polymeric formula are~     tolerated by children with SAM and help to reduce intestinal inflammation. We also aim to~     learn more about the intestinal inflammation in general that occurs in SAM by observing~     carefully the effect of these specific formulae and to do in-depth metabolic analyses.~   "
70865|NCT02639403|"~     Radiotherapy (RT) is a potentially effective method in the treatment of symptoms of rectal~     carcinomas. Nevertheless, almost all the evidences about palliative RT in rectal cancer have~     been published more than two decades ago and were based on 2D conventional RT, which is~     nowadays no longer used. Consequently, prospective studies on the efficacy of 3D-RT in the~     management of symptomatic rectal cancer are still lacking. The aim of this prospective study~     was to assess the efficacy of palliative short-course 3D RT (SCRT) in patients with~     symptomatic obstructive rectal cancer.~   "
70866|NCT02639390|"~     The overall goal is to further develop a robotic exoskeleton for neurorehabilitation of arm~     function after stroke. The investigators previously developed a novel training protocol that~     combined the ARMin and HandSOME exoskeletons. This is one of only a few arm exoskeletons that~     allow coordinated whole limb training in reach and grasp tasks with both virtual and real~     objects. However, the robot has a very large inertia and friction, and only gross grasp~     patterns are available. In development work, the investigators will significantly modify the~     AMRin and HandSOME to deliver a state-of-the-art lightweight robotic exoskeleton capable of~     retraining a wide range of functional activities. In the subsequent testing phase, a clinical~     trial will examine the effects of robotic training in chronic stroke subjects.~   "
70867|NCT02639377|"~     The purpose of this study is to analyze the efficacy of 0.12% chlorhexidine gluconate as a~     chemical adjuvant for the treatment of peri-implant mucositis in single implants compared~     with homologous teeth with gingivitis, in a non-surgical treatment protocol with a six-month~     follow-up.~   "
70868|NCT02639364|"~     The aim of this study is to assess the effects and safety of the early application of~     BILEVEL-APRV protocol and conventional ventilation strategy that used low tidal volume and~     adequate PEEP level in ARDS patients .~   "
70869|NCT02639351|"~     Dosage-Escalation Study to Evaluate the Safety and Immunogenicity of an Aluminium~     Hydroxide/LHD153R Adjuvanted Meningococcal C-CRM197 Conjugate Vaccine in Healthy Adults~     (18-45 years of age).~   "
70870|NCT02639338|"~     The primary objective of this study is to evaluate the efficacy, safety, and tolerability of~     treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC)~     for 8 weeks and of treatment with sofosbuvir/velpatasvir (SOF/VEL) FDC for 12 weeks in~     participants naive to direct-acting antivirals (DAA) with chronic genotype 3 hepatitis C~     virus (HCV) infection and cirrhosis.~   "
70945|NCT02638350|"~     The main objective is to assess the validation of the diagnosis early acute pulmonary edema~     in elderly patients with acute respiratory distress, admitted in a host of vital emergency~     services by lung ultrasound associated with the measurement of the inferior vena cava.~   "
70871|NCT02639325|"~     Background:~      Some people with brain tumors have seizures related to the tumor. This is called~     tumor-related epilepsy. Usually brain tumors are treated by removing as much of the brain~     tumor as possible without causing problems. Researchers think this may improve the outcome~     for people with brain tumors. It may completely relieve or greatly reduce the number of~     seizures they have.~      Objectives:~      To evaluate people with brain tumors that are associated with seizures and to offer surgical~     treatment. Also, to study how surgery affects seizures.~      Eligibility:~      People age 8 and older who have a brain tumor with associated seizures. They must be willing~     to have brain surgery to treat their epilepsy.~      Design:~      Participants will be screened with a review of their medical records.~      Participants will have a medical history and physical exam.~      Participants will be admitted to the hospital at NIH. They will have~      Medical history~      Physical exam~      Neurological exam~      Tests of memory, attention, and thinking~      Questions about their symptoms and quality of life~      Blood drawn~      They may also have:~      MRI or CT scan. They will lie on a table that slides in and out of a machine that takes~     pictures. For part of the MRI, they will get a dye through an intravenous (IV) catheter.~      Video electroencephalography monitoring. Electrodes will be placed on the scalp. The~     participant s brain waves will be recorded while doing normal activities. Participants will~     be videotaped.~      Participants will keep a seizure diary before and after surgery.~      Participants will have surgery to remove their brain tumor and the brain area where their~     seizures start.~      They will stay in the hospital up to a week after surgery.~      Participants have for follow-up visits at NIH.~   "
70872|NCT02639312|"~     Background:~      Some head and facial abnormalities are rare and present at birth. Others are more common, and~     may not show up until puberty. These conditions have different causes and characteristics.~     Researchers want to learn more about these conditions by comparing people with face, head,~     and neck abnormalities to family members and to healthy volunteers without such conditions.~      Objectives:~      To learn more about abnormal development of the face, head, and neck. To determine their~     genetic variants.~      Eligibility:~      People who have not had surgery for facial trauma:~      People ages 2 and older with craniofacial abnormalities (may participate offsite)~      Unaffected relatives ages 2 and older~      Healthy volunteers ages 6 and older~      Design:~      Participants will be screened with medical history and physical exam focusing on head, face,~     and neck~      Participants may be followed for several years. Visits may require staying near the clinic~     for a few days.~      A visit is required for the following developmental stages, along with follow-up visits:~      Age 2 6~      Age 6 10~      Age 11 17~      Age 18 and older~      Visits may include:~      Medical history~      Physical exam~      Questionnaires~      Oral exam~      Blood and urine tests~      Cheek swab: a cotton swab will be wiped across the inside of the cheek several times.~      Cone beam CT scan (CBCT): x-rays create an image of the head, face, teeth, and neck.~     Participants will~      stand still or sit on a chair for about 20 minutes while the scanner rotates around the head.~      Photos of the head and face~      Offsite participants will provide:~      Copies of medical and dental records~      Leftover tissue samples from previous surgery~      Blood sample or cheek swab~   "
70873|NCT02639299|"~     Background:~      Malaria is a serious infection caused by a parasite. People get malaria when an infected~     mosquito bites them. Malaria can cause major health and social problems in places were~     malaria is common, such as Africa but can also affect travelers who have never been exposed~     to malaria. Researchers at the NIH want to find a safe and effective malaria vaccine,~     antimalarial drugs, or prevention regimen. To do this, healthy volunteers are recruited under~     a general screening study in order to see if are qualified to join a future malaria study.~      Objective:~      To screen healthy volunteers to see if they are eligible to join investigational malaria~     studies. The studies will be trials of investigational antimalarial drugs, malaria vaccines,~     or prevention regimens. They may also involve controlled human malaria infection trials.~      Eligibility:~      Healthy people ages 18 50~      Design:~      Participants will first be prescreened by phone.~      Participants will be screened with:~      Medical history~      Physical exam~      Blood and urine tests~      Participants may go more than 1 year without joining a clinical trial. If this happens, they~     may be re-contacted to see if they still want to be part of this screening protocol. Those~     who still want to participate and have had relevant medical changes will be rescreened.~   "
70874|NCT02639286|"~     Background:~      Partial lipodystrophy is a deficiency of body fat in parts of the body (usually the arms and~     legs). People with partial lipodystrophy often get high blood triglyceride (fat) level,~     insulin resistance, diabetes and other problems. Researchers think the new drug ISIS 304801~     can help treat health problems caused by partial lipodystrophy.~      Objective:~      To see if ISIS 304801 will improve blood fat (triglyceride levels), diabetes, and liver~     disease, and reduce some risks for heart disease caused by partial lipodystrophy.~      Eligibility:~      Adults at least 18 years old with partial lipodystrophy.~      Design:~      Participants will be screened during a 1-week stay at NIH. They will have:~      Blood and urine tests~      Physical exam.~      Assignment to get either the study drug or placebo.~      Instructions for how to inject the drug.~      Body measurements.~      Heart tests.~      Participants will give themselves injections of the drug or placebo once a week at home. Some~     may test blood sugar by finger pricks. They will have monthly phone calls and nurse visits to~     take blood tests.~      After 4 months, participants may continue the study for 1 year. All participants will get the~     study drug.~      Participants will have study visits at NIH every 4 months. These may include:~      Insulin sensitivity measurement: Insulin and sugar will be infused through 2 intravenous (IV)~     lines in the arms. Blood will be drawn.~      Sugar and fat metabolism measured by IV infusions and blood tests.~      Special x-ray scan to measure body fat.~      Liquid meal then blood collected by IV catheter in the arm.~      Magnetic resonance imaging scans.~      Neck ultrasound.~      Questionnaires.~      Liver biopsy (optional)~      Injection of heparin (a blood thinner) before a blood test.~      After finishing the drug, participants will have 1 nurse visit and 1 visit to NIH.~   "
70883|NCT02639169|"~     ABSTRACT The transplant allogeneic hematopoietic stem cell transplantation (HSCT Alo) is a~     therapeutic medical treatment carried out in combat various neoplastic hematologic disorders,~     congenital, genetic or acquired. In this procedure, which combines high-dose chemotherapy and~     or radiation and has a degree of high cytotoxicity, the patient goes for a social solitary~     confinement, which causes psychological distress, pain, anxiety, mood disorders and can lead~     to depression. The music therapy was applied and the purpose of decreasing the insulation.~     This is a randomized controlled study.~      Method: Apply the intervention of live music sessions through the techniques of music~     therapy; assess and quantify through the visual analog scale (VAS) and numeric. The dependent~     variables, pain, anxiety and mood of the participants selected randomly for the experimental~     group music therapy (EGM) n=50, and compare with the control group (CG) n=50, which received~     only the standard treatment.~   "
70884|NCT02639156|"~     To evaluate tolerance and acceptability of AYMES LONDON in patients requiring supplementary~     oral nutritional support compared with currently available alternatives.~   "
70875|NCT02639273|"~     Background:~      Drugs like nalmefene interfere with opioid receptors. This might reduce drinking. The gene~     OPRM1 determines opioid receptor functions. Researchers want to see if nalmefene affects~     people s responses to alcohol cues. They also want to compare how nalmefene affects people~     with different forms of OPRM1.~      Objectives:~      To test nalmefene s effects on alcohol self-infusion and responses to alcohol cues. To test~     the role of different forms of OPRM1 on these effects.~      Eligibility:~      Healthy heavy drinkers ages 21 60:~      Women: over 15 drinks weekly~      Men: over 20 drinks weekly~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Heart, blood, and urine tests~      Questionnaires~      Participants will have three 10-hour visits and one 2-hour follow-up visit. They will take a~     taxi. Visits are about 1 week apart.~      Before visits, participants cannot drink alcohol for 1 day or take medicine for 3 days.~      All study visits:~      Questionnaires~      Heart monitor~      Two-hour alcohol session: A needle guides a thin plastic tube into a vein in each arm. One~     tube receives alcohol. The other draws blood. Participants give themselves alcohol by~     pressing a button on a computer.~      Relaxing at the center until breath alcohol falls below 0.02 percent, or for 3 hours.~      Visits 2 and 3:~      Swallowing nalmefene or placebo.~      One-hour brain MRI: Participants lie on a table with a coil on their head. They press buttons~     in response to computer cues.~      Follow-up visit: participants will discuss their drinking habits.~   "
70876|NCT02639260|"~     Three kidney diseases that affect both children and adults are minimal change disease (MCD),~     focal segmental glomerulosclerosis (FSGS) and membranous nephropathy (MN). These diseases are~     characterized by proteinuria (protein in the urine) and in the cases of FSGS and membranous~     nephropathy, a tendency to progressive scarring of the glomerulus (the filtering units of the~     kidneys) that leads to end-stage kidney disease. Several therapies are available for these~     diseases, but these therapies do not provide lasting reduction in proteinuria for many~     subjects. In the current study, carried out at the NIH Clinical Center, we are testing a new~     therapy, ManNAc. ManNAc is a naturally occurring uncharged sugar that cells use to produce~     negatively charged sialic acid. Kidney cells attach sugars such as sialic acids to proteins~     and lipids (resulting in glycans), and these assist in cell function. Mouse models of the~     inherited muscle disease GNE myopathy, which is due to sialic acid deficiency on muscle~     glycans, responded favorably to oral ManNAc therapy and a clinical trial of ManNAc is ongoing~     in GNE myopathy subjects. There is evidence that some subjects with MCD, FSGS or MN do not~     put enough sialic acids on glomerular proteins and so ManNAc therapy may increase sialic acid~     production and sialylation of glomerular proteins in these subjects. For the present study,~     we will recruit 12 subjects who have MCD, FSGS or MN. Each subject will stay at the NIH~     Clinical Center for 11 days to receive oral ManNAc. The primary purposes of the study are to~     determine: 1) the safety of ManNAc in subject s with kidney disease; and 2) the ManNAc and~     sialic acid metabolism related to ManNAc in subjects with kidney disease. Concentrations of~     ManNAc and sialic acid will be measured in plasma at various times before and after dosing.~     If this study suggests that ManNAc is safe in subject with kidney disease, the results will~     be used to plan a longer-term study to determine whether it is effective at reducing~     proteinuria....~   "
70877|NCT02639247|"~     The primary objectives of the study are to evaluate the efficacy, safety, and tolerability of~     treatment with sofosbuvir/velpatasvir/voxilaprevir (Vosevi®; SOF/VEL/VOX) fixed-dose~     combination (FDC) for 12 weeks and of sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) FDC for 12~     weeks in direct-acting antiviral (DAA)-experienced adults with chronic hepatitis C virus~     (HCV) infection with or without cirrhosis who have not received prior treatment with a~     regimen containing an inhibitor of the HCV NS5A protein.~   "
70878|NCT02639234|"~     This is an open label phase 2 study to evaluate the combination of Vigil™ and nivolumab in~     advanced or metastatic NSCLC that is progressive on or after one prior platinum-based~     systemic therapy. Patients meeting study eligibility criteria will receive Vigil™ every 2~     weeks (for a minimum of 4 and a maximum of 12 doses) and nivolumab every 2 weeks. The~     combination of Vigil™ and nivolumab will demonstrate a higher objective response rate (ORR)~     than the historical ORR of single agent nivolumab in patients with advanced NSCLC.~   "
70879|NCT02639221|"~     The principal aim of this study is to obtain safety and tolerability data when PXT002331 is~     administered orally as single and multiple doses to healthy subjects.~   "
70880|NCT02639208|"~     The number of patients 60 and older with breast cancer is increasing as our population ages.~     Despite the fact that the majority of breast cancers occur in patients 60 and over, these~     patients are consistently under-represented in clinical trials. Because patients 60 and older~     are an under-studied group, investigators do not have detailed information on the side~     effects and experiences for these patients receiving chemotherapy. Understanding the side~     effects patients receiving chemotherapy experience is an important part of this study.~      In addition, past research has shown that having poor social support can affect quality of~     life, mood, and outcomes for people with cancer. However, few studies in the past have~     focused on improving the quality of life and support systems that patients have while they~     receive treatment.~      This research study is evaluating how engaging in an online support community may improve the~     experience of older patients receiving chemotherapy.~   "
70881|NCT02639195|"~     This study has two segments the first is a chart and outcome assessment of patients treated~     at Clear Passage (CP) with a history of small bowel obstruction (SBO). These patients have~     completed multiple questionnaires as a standard of care for outcome monitoring in the clinic~     setting, no new data will be collected. The second segment is a prospective observational,~     online questionnaire based study of subjects with a history of SBO not treated at CP. Data on~     the impact of quality of life (QOL) over time of subjects not treated at CP will be assessed~     using the same questionnaire used as standard of care in the clinic twice, 90 days apart.~     This will be accomplished using the NIH Assessment Center, with subjects able to complete the~     questionnaires with ease via the internet. As this segment is observational, there is minimal~     risk to these subjects. The data obtained from the untreated subjects will allow for~     reporting of overall impact on QOL in this population, data that is not available, as well as~     provide a control group for assessment of improvement for interventions for SBO.~   "
70882|NCT02639182|"~     The purpose of this study is to evaluate the progression free survival (PFS), based on~     investigator radiologic review, of AGS-16C3F compared to axitinib in subjects with metastatic~     renal cell carcinoma.~   "
70885|NCT02639143|"~     This is a prospective, randomized, parallel design study to investigate that ticagrelor could~     attenuate inflammatory cell infiltration in thrombus aspirated from ST elevation myocardial~     infarction (STEMI) patients. The anticipated duration of the study is approximately 9 months,~     including an anticipated enrolment period of 8 months and follow-up period of 1 month.~     Patients within 12 hours of symptom onset were randomly assigned in a one-to-one ratio to~     receive ticagrelor or clopidogrel at time of STEMI diagnosis. The primary endpoint was the~     extent of inflammatory cell infiltration in thrombus aspirated from STEMI patients, expressed~     as number of total inflammatory cells per mm2 thrombus area.~   "
70887|NCT02639117|"~     This is a Phase 1 single site study to evaluate the safety and efficacy of a combination~     therapy that includes the administration of vismodegib and photodynamic therapy (PDT) using~     aminolevulinic acid (20 percent ALA) for multiple basal cell carcinomas. All subjects will~     receive vismodegib 150mg by mouth every day for 3 months, and undergo three PDT sessions with~     topical application of ALA. The PDT will be first administered at 7+ 4 business days after~     the beginning of the Erivedge and at 45 + 5 business days and then at 90 + 10 business days.~      Primary Objective The primary objective of this study is to determine the safety of~     photodynamic therapy (PDT) with vismodegib (combination therapy) for patients with multiple~     BCC.~      3.2 Secondary Objective To evaluate the overall response rate (ORR) to the combination~     therapy in patients with multiple BCCs.ORR is defined as the proportion of evaluable study~     subjects who has complete or partial response to the study treatment.~   "
70888|NCT02639104|"~     This study investigates one of the mechanism factors of neck pain. Cervical lordotic angle~     alterations affect the tension of serratus anterior muscle. Expected result that the long~     thoracic nerve can be affected in this situation, and could be observed the functional~     changes of the nerve with serratus anterior electromyographic findings.~   "
70889|NCT02639091|"~     Determine the safety, tolerability and maximum tolerated dose of anetumab ravtansine (BAY~     94-9343) in combination with pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 in subjects with~     mesothelin-expressing predominantly epithelial mesothelioma or nonsquamous non-small-cell~     lung cancer.~   "
70890|NCT02639078|"~     Single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and~     pharmacodynamics of TD-0714 in healthy subjects.~   "
70891|NCT02639065|"~     This is a phase II, open-label, single arm, single-stage study. A total of 23 evaluable~     patients will be enrolled. If total number of patients free of disease relapse at 1 year is~     less than or equal to 15, the drug would not be considered for further study in this setting.~     After six patients are treated with at least one dose of study drug, they will be observed~     for a minimum of 60 days. During the 60-day observation period, further accrual will be~     halted to evaluate unacceptable toxicities warranting early closure of the trial defined~     as:~        -  Any definitive durvalumab-related death. A durvalumab-related death will be continuously~          monitored throughout the trial and the trial will be suspended for re-evaluation~          whenever such an event is confirmed.~        -  Any unexpected and previously unreported grade 4 toxicities definitely related to~          durvalumab.~   "
70892|NCT02639052|"~     The purpose of this study is to determine if Botox is effective in the treatment of an~     experimentally induced itch that mimics chronic itch in healthy volunteers.~   "
70893|NCT02639039|"~     The purpose of this study is to determine if trigger point dry needling (TDN) is as effective~     as cortisone injection (CI) in reducing pain and improving function in patients with greater~     trochanteric pain syndrome (GTPS).~   "
70894|NCT02639026|"~     The main purpose of this study is to determine how best to combine hypofractionated~     radiotherapy, MEDI4736, and tremelimumab and to determine how safe and tolerable~     hypofractionated radiotherapy, MEDI4736, and tremelimumab are when given together in subjects~     with metastatic, melanoma, non small cell lung cancer (NSCLC), breast cancer, and pancreatic~     cancer.~   "
70895|NCT02639013|"~     Early detection of intra-abdominal hypertension is essential to the prevention of abdominal~     compartment syndrome and requires close surveillance of intra-abdominal hypertension in~     patients at increased risk. intra-abdominal hypertension measurements are often taken by the~     bedside nurse, and in some cases, initiation of serial intra-abdominal hypertension~     monitoring is prompted by critical care nurses.~   "
70896|NCT02639000|"~     Single center randomized study including 388 women aged less than 39 years, performing in~     vitro fertilization, to determine if blastocyst stage (Day 5 to 6) embryo transfer (ETs)~     improves implantation and pregnancy rate compared with cleavage stage (Day 2 to 3) ETs.~   "
70897|NCT02638987|"~     An experimental study will be conducted to evaluate the effect of a single dry needling~     session on surface EMG activity (primary outcome measure), muscle tone, elasticity, stiffness~     and pain (secondary outcome measures) of the upper trapezius, in female office workers with~     trapezius myalgia.~   "
70898|NCT02638974|"~     Women prisoners are more likely to commit suicide or self-harm than women in the community or~     male prisoners.~      Healthcare services have improved how they manage self-harm in the community and prisons.~     However, there has been little focus on the recovery of people with self-harm scars. Medical~     skin camouflage (MSC) is a British National Formulary-listed topical cream designed to cover~     skin conditions. Research on MSC has focused on its use with non-self-harm marks e.g. burns.~     The evidence from this research suggests that the cream helps women feel better and do more~     activities. There is little/no evidence about the effects of the preparation for women who~     self-harm and for prisoners.~      This research was funded by the National Institute for Health Research Research for Patient~     Benefit Programme. In the research the investigators will examine whether it is possible and~     practical to use MSC in prison. The investigators will ask women prisoners and staff what~     they think about the cream. The research has four parts. In the first part the investigators~     will run focus groups with women prisoners and prison staff to find out the best way to~     deliver the MSC intervention and how to measure its effects. In the second part the~     investigators will design a programme for delivering the MSC. The investigators will then~     train 6-10 long-term prisoners to become skin camouflage practitioners. The final part will~     involve a small randomised controlled trial with 40 women prisoners; 20 will be allocated to~     the intervention group and will use the MSC for 6 weeks. The investigators will measure their~     mood, thoughts of self-harm and wellbeing before and after they use MSC. The investigators~     will compare these results with 20 women who have not used MSC (waitlist control group). All~     women taking part will be placed at random into the control or the treatment group. The~     control group will receive the MSC after the research has ended.~      Potential benefits of this study may be an increase in self-esteem and quality of life for~     the women prisoners. As women recover they may be less likely to self-harm.~   "
70899|NCT02638961|"~     Heart failure (HF) with preserved ejection fraction (HFpEF) has become the most prevalent~     form of HF in developed countries. Despite its increasing in prevalence, there is no~     evidence-based effective therapy for HFpEF The purpose of this study was to evaluate whether~     inspiratory muscle training (IMT), functional electrical stimulation (FES), or combination of~     both improve exercise capacity as well as left ventricular diastolic function, biomarkers'~     profile, quality of life (QoL) and prognosis in patients with HFpEF.~   "
70900|NCT02638948|"~     The purpose of this study is to determine whether the study drug, BMS-986142, is safe and~     effective in treating moderate to severe rheumatoid arthritis in subjects with an inadequate~     response to methotrexate or methotrexate and up to 2 tumour necrosis factor (TNF) Inhibitors.~     Patients who qualify will be randomized to either one of 3 doses of BMS-986142 or placebo in~     1:1:1 randomization for 12 weeks. Disease activity and safety will be assessed over the~     course of the study.~   "
85232|NCT02451384|"~     Acccording circulating tumor cells to compare the differences of different methods(routine~     method、no-touch principle method、laparoscopy method) to remove the ductal adenocarcinoma of~     pancreatic body and tail.~   "
70902|NCT02638922|"~     Objective~      To evaluate the phenotypic characteristics and diagnoses in a large cohort of 304 consecutive~     girls referred due to tall stature. Furthermore, to evaluate the effect of oral~     administration of 17β-estradiol on predicted adult height in constitutionally tall statured~     girls.~      Design~      A single-centre retrospective observational study of 304 girls evaluated due to tall stature~     between 1993 and 2013.~      Setting~      Tertiary referral centre for pediatric endocrinology.~      Participants~      A total of 304 girls were evaluated for tall stature of whom 39 (13%) were excluded due to~     missing data, reclassification, overgrowth syndromes or associated comorbidities. Another 58~     (19%) girls did not fulfil auxological criteria for constitutionally tall stature (CTS),~     resulting in a total of 207 (68%) girls eligible for analysis.~      Main Outcome Measures~      The effect of oral treatment with 17β-estradiol on height, predicted adult height (PAH),~     final height and circulating hormones in constitutional tall statured girls.~   "
70903|NCT02638909|"~     The available data indicate that Ceritinib has substantial anti-tumor activity in patients~     with anaplastic lymphoma kinase (ALK) and ROS1 rearranged non-small cell lung cancer (NSCLC).~     This trial will investigate the potential of Ceritinib in patients with advanced~     gastrointestinal malignancies with ALK and ROA1 rearrangement, and for whom there is no~     available therapeutic option.~   "
70904|NCT02638896|"~     The primary objective of this study is to evaluate the efficacy of safety of etanercept dose~     reduction combined with sulfasalazine in ankylosing spondylitis (AS) patients who have~     achieved a significant clinical response.~   "
70905|NCT02638870|"~     Irritable bowel syndrome (IBS) is a functional bowel disorder with recurrent abdominal pain~     and disordered defecation and is one of the most common gastrointestinal problems. In~     practice, IBS was frequently diagnosed as an exclusion diagnosis for patients with recurrent~     abdominal pain without an organic cause. Visceral hypersensitivity is the major contributing~     factor of abdominal pain in IBS. Accordingly, tricyclic antidepressants (TCAs) are widely~     used for IBS, especially if abdominal pain is a prominent symptom. Indeed, meta-analysis also~     exhibits the clinically significant efficacy of low dose TCAs in IBS. Nevertheless, over 40%~     of IBS patients receiving TCAs had no improvement in symptoms after treatment. Theoretically,~     if TCAs are used for IBS patients with hypersensitivity, its efficacy could be increased.~      Although rectal distension test might be used to identify hypersensitive patients with IBS,~     it has been used only for clinical research because it is painful for the patient. On the~     contrary, colonoscopy is frequently performed in IBS patients to rule out organic disease and~     for the purpose of colorectal cancer screening. In a study by Kim and colleagues, IBS~     patients reported higher pain score after colonoscopy than non-IBS patients. This has~     prompted the hypothesis that pain scoring during/after colonoscopy could also segregate IBS~     patients with visceral hypersensitivity showing better treatment response of TCA than those~     without.~      The aims of the present study were to evaluate the colonoscopy-related pain perception and~     the treatment response of amitriptyline in IBS patients and to investigate the predictive~     values of the colonoscopy-related pain scale in identifying IBS patients with a response to~     amitriptyline treatment.~   "
70906|NCT02638857|"~     Objectives:~      The purpose of this study is to evaluate the safety and efficacy of dendritic cell-precision~     multiple antigen T cells with transcatheter arterial chemoembolization in the treatment of~     hepatocellular carcinoma.~      Methods： This study designs a novel therapy using dendritic cell-precision multiple antigen T~     cells. 60 patients will be enrolled. They are randomly divided into transcatheter arterial~     chemoembolization group and dendritic cell-precision multiple antigen T cells combined with~     transcatheter arterial chemoembolization group. Treatments will be performed every 3 weeks~     with a total of three periods. The mail clinical indicators are Progression-Free-Survival and~     Overall Survival.~   "
70907|NCT02638844|"~     Assessment of right ventricular (RV) function in patients with acute respiratory syndrome~     (ARDS) is warranted because RV failure is frequent and associated with worse outcome.~     Transthoracic echocardiography is the cornerstone of RV assessment but it remains~     challenging. Quantification of RV deformation by speckle-tracking imaging echocardiography~     (STE) is a widely available and reproducible technique that readily provides an integrated~     analysis of all segments of the RV. This study aims to investigate the accuracy of~     STE-derived strain parameters in assessing RV function during ARDS.~   "
70908|NCT02638831|"~     Comparative clinical study of Ketorolac tromethamineand Ketoprofen gel in patients with~     Gonarthrosis and Low back pain.~   "
70909|NCT02638818|"~     The purpose of this study is to evaluate the impact of the quality of life in patients~     undergoing the Whipple procedure (pancreaticoduodenectomy, PD) for pancreatic cancer. The~     Whipple procedure can be done by laparoscopic (small incisions) or an open procedure (large~     incision) to treat the patients cancer. The goal of this study is to see if there is any~     difference in quality of life between patients who undergo the laparoscopic or the open~     Whipple procedure. Surgical technique (minimally invasive versus open) will be at the~     discretion of the operating surgeon. Patients will not be randomized to a treatment arm.~      A subset of these patients will also be asked to take part in a pre- and postoperative~     in-depth interview to explore the lived experiences of patients with resectable pancreatic~     cancer.~   "
70910|NCT02638805|"~     A Phase 3b, open-label, randomized, multicenter, safety and tolerability study of ITCA 650 in~     subjects with Type 2 diabetes taking liraglutide and metformin.~   "
70911|NCT02638792|"~     The purpose of this study is to examine if an internet-based exposure therapy is more~     effective in reducing excessive worry amongst patients who suffer from this problem than is~     internet-based stress management training.~   "
70946|NCT02638337|"~     The objective of this study is to evaluate the efficacy and safety of ospemifene 60 mg once~     daily (QD) compared with placebo in treatment of vulvo-vaginal atrophy (VVA) due to menopause~     in women with moderate to severe vaginal dryness as the most bothersome symptom (MBS) of VVA.~   "
70947|NCT02638324|"~     The overactivity of sympathetic nervous system is worsening the hemodynamic state of heart~     failure patients. The present study is planned to reduce the sympathetic tone in patients~     with severe heart failure by renal nervous denervation.~   "
70948|NCT02638311|"~     Prospective multicenter sample collection and testing study.~   "
73961|NCT02598778|"~     This study compares four mouth rinses in their regard to reducing Streptococcus Mutans after~     use. The four mouth that will be compared are chlorhexidine gluconate (.12%), sodium fluoride~     (.05%), coconut oil, and deionized water.~   "
70912|NCT02638779|"~     The fact that sepsis disrupts immune system homeostasis by inducing an initial cytokine~     storm, that participates to occurrence of organ failures and early death, followed by a~     compensatory anti-inflammatory response leading to immunosuppression, is now well~     established. This immunomodulating response results in a higher risk of secondary infections~     and is associated to 2/3 of deaths related to septic shocks. Follow up of patients' immune~     status with time is crucial to guide therapy management. Objective of REALISM project is to~     demonstrate existence of this immunosuppression phase, by providing strong epidemiologic data~     for septic shock patients, but also by extension to other situations of inflammatory~     aggressions like severe severe trauma or burns, or major surgery. This project will provide~     tools to predict occurrence of secondary infections and guide patient management by comparing~     innovating immunomonitoring tools to reference tests non already adapted to a routine patient~     management.~      Targeted populations are adult patients hospitalized for septic shock, severe trauma~     (including severe burn) or major surgery and healthy volunteers, whom blood samples will~     serve to validate reference intervals of the two reference tests.~   "
70913|NCT02638766|"~     Evaluate the treatment with regorafenib in patients with metastatic and/or unresectable~     KIT/PDGFR wild type GIST in the first line setting.~   "
70914|NCT02638753|"~     Although education on neurophysiology of pain improves disability, there are limited effects~     in pain intensity. Hypnosis is an approach that has proven useful in pain intensity and~     psychosocial aspects in some chronic pain conditions, but there is insufficient evidence of~     its contribution in patients with chronic non specific low back pain. The aim of the study is~     to assess the efficacy of combining education on neurophysiology of pain and hypnosis in~     patients with chronic non specific low back pain in pain and disability outcomes.~   "
70915|NCT02638740|"~     Periodontal disease is a chronic inflammatory process accompanied by destruction of~     Periodontium, and sometimes loss of teeth. Periodontal disease is highly prevalent especially~     in developing and underdeveloped countries affecting more than 80% population.~     Epidemiological studies have shown that about 10% of the adult population suffer from severe~     periodontitis (Brown et al. 1990, Gjermo 1998). Studies indicate that the periodontal lesion~     is not strictly a localized process but may lead to systemic alterations in immune system.~     Various studies confirm the microbial etiology of periodontal disease.~   "
70916|NCT02638727|"~     The purpose of this study is to determine the efficacy of oral L-Citrulline on endothelial~     function and vasodilation in patients with coronary artery disease(CAD) by evaluating the~     brachial artery diameter in the antecubital area by ultrasonography.~   "
70917|NCT02638714|"~     A single arm, single center trial to assess the safety and efficacy of restoring function in~     damaged optic nerves using autologous purified populations of bone-marrow derived stem cells~     (BM-SCs) through a 24 month follow up period.~   "
70918|NCT02638701|"~     Patients harboring dolichoectactic vertebrobasilar (DVB) aneurysms are at risk of suffering~     SAH, ischemic stroke, and/or brainstem compression and many patients are not offered invasive~     treatment due to the futility of existing surgical methods. Consequently, there is demand for~     development of medical therapy for DVB aneurysms~   "
70919|NCT02638688|"~     Objective: To compare 2-dimensional and 3-dimensional ultrasound measurements with the actual~     myomas volume after surgical removal, to clinically test the validity and usability of 3D~     ultrasound technology as opposed to conventional 2D real-time ultrasound and to assess the~     reliability of different ultrasound methods to measure volume of uterine fibroids.~   "
70920|NCT02638675|"~     The objective of this randomized control trial is to examine whether incentives-for-steps~     (i.e. $1 per day step count goals are reached) increase daily step counts among physically~     inactive hospital employees.~   "
70921|NCT02638662|"~     The effect of stress on IVF outcomes.~   "
70922|NCT02638649|"~     This is a pilot observational feasibility study of the ability of paramedics to assess~     thoracic ultrasound findings in the prehospital environment. The primary goal of the study is~     to determine whether paramedics are able to accurately assess for sonographic B-lines in~     patients with undifferentiated shortness of breath at least 80% of the time in the~     prehospital environment using a portable ultrasound (U/S) device.~   "
70923|NCT02638636|"~     The purpose of this study is to examine if an internet-based exposure therapy is effective in~     reducing Fibromyalgia symptoms and impact amongst patients with Fibromyalgia.~   "
70924|NCT02638623|"~     The investigators are testing the hypothesis that administering 2L of body temperature warmed~     lactated ringer's intravenously prior to surgery can optimize the postoperative and recovery~     of patients undergoing total hip and total knee arthroplasty.~   "
70925|NCT02638610|"~     The aim of the study: Assessment of Changes of Periocular Skin Sensation Following Eyelid and~     Ocular Surface Surgeries.~      Study design: an interventional study that will be conducted at the ophthalmology department,~     Meir hospital, Kfar Saba, Israel.~      the study will include 60 healthy patients, at the ages of 40-80, which are candidates for~     eyelid surgery: blepharoptosis repair, blepharoplasty, ectropion repair and entropion repair.~      The patients will be recruited from Meir's ophthalmology outpatient clinic. Each patient will~     undergo a full ophthalmologic examination including relevant assessment of the specific~     eyelid pathology.~      The eyelid's sensation will be assessed at 6 points of the eyelid using the Cochet-Bonnet~     filament-type aesthesiometer (Luneau Ophtalmologie, Paris, France). Measurements will take~     place before surgery, and two weeks, three months and six months after surgery.~   "
70926|NCT02638597|"~     This project will test whether gemfibrozil, a well-studied medication for high cholesterol,~     will help people stop smoking nicotine cigarette smoking. The study will also test whether~     gemfibrozil decrease cravings for cigarette and the desire to smoke.~   "
70927|NCT02638584|"~     This study compared Ulcer healing rate of Ilaprazole 20mg or Rabeprazole 20mg in the patients~     undergone Endoscopic Submucosal Dissection for Gastric Adenoma or Early Gastric Cancer and~     investigated Prevention of gastrointestinal bleeding.~   "
70928|NCT02638571|"~     The overall purpose of the study is to evaluate nutrition education interventions to promote~     pulse incorporated complementary food to the wider rural community through the government~     system to improve maternal knowledge, attitude and practice (KAP) and nutritional status of~     young children (6 to 24 months). The hypothesis is that nutrition education improves mothers~     knowledge, attitude and practice of pulse incorporated complementary food and improves~     dietary intake of iron and zinc and nutritional status of young children.~   "
70929|NCT02638558|"~     Split-dose cleansing regimens for colonoscopies, independently from the type of laxative~     used, are now recommended over full (one day)-dose regimens from all the major guidelines. It~     is wellknown that splitting the dose (half of the dose the night before and half the day of~     the colonoscopy) is safe and guarantees a better cleansing of the colon and thus a higher~     chance of identifying mucosal lesions. This is crucial both in terms of achieving a~     high-quality colonoscopy and in terms of time and money saved.~      Still, there are some issues about compliance and tolerability with split-dose regimens. Two~     recent prospective works have shown that only a small number of patients (33%) chooses the~     split-dose regimen when the colonoscopy is scheduled before 10 a.m. and when patients are~     forced to used the split-dose, 1/7 did not comply with it, especially if the procedure is~     before 10 a.m. The most common concerns are about early wake-up, travel interruption and fear~     of incontinence. Both these papers state that strategies to reduce this noncompliance are~     needed.~      The investigators aim to prove whether an active action (an oral explanation before the~     colonoscopy about why split-dose regimens are better) may improve patients' compliance in~     endoscopies scheduled in the early morning (from 8 to 10 a.m).~   "
70930|NCT02638545|"~     The current treatment regimen of patients with septic shock requires a sufficient hemodynamic~     support aiming to preserve tissue oxygen requirements and perfusion. Therefore, aggressive~     fluid challenge and vasopressor agents play a pivotal role. To increase total peripheral~     resistance and preserve organ perfusion, a continuous infusion of catecholamines is often~     needed. Because sepsis is usually associated with adrenergic receptor and post-receptor~     abnormalities, the efficacy of such treatment regimens often gradually decreases over time,~     thereby complicating hemodynamic support. Experimental evidence suggest that α-2 agonists~     increase pressor responsiveness following lipopolysaccharide administration. This study will~     assess the effects of the sedation with dexmedetomidine (α-2 agonist) on norepinephrine~     requirements in patients with septic shock.~   "
70931|NCT02638532|"~     The specific aim of this outcomes study is to assess if the volume of fat that is injected~     into the foot is retained at 6 months, to determine the retention over time, and assess the~     quality of the bone before and after treatment. We will also correlate adipose stem cell~     characteristics to the fat retention over time.~   "
70932|NCT02638519|"~     This study involves imaging participants' brains using MRI. The goal is to develop a~     high-resolution, high-sensitivity imaging tool, hyperpolarized xenon functional brain~     magnetic resonance imaging, which can provide more sensitive measurement of brain function,~     facilitating the development of drugs for more successful treatment of Alzheimer's disease.~   "
70933|NCT02638506|"~     Background : Headaches are a common presentation for children consulting to the Emergency~     Department (ED). However, only few studies have evaluated the rapid pain improvement provided~     by medications in the acute management of headaches in the pediatric population.~      Objective : To evaluate pain reduction provided by intranasal fentanyl (INF) compared to~     placebo in addition to ibuprofen for children presenting to a pediatric ED with moderate to~     severe headaches.~      Methods : A single-center, double-blind, randomized, placebo controlled clinical trial will~     be conducted in an urban, university-affiliated, tertiary care pediatric hospital ED. All~     children eight to 18 years old who will present to the ED with headaches as a main chief~     complaint and with pain of ≥ 36 mm out of 100 on Visual Analog Scale (VAS) will be recruited.~     Study participants will be randomly allocated to receive INF 1.5 mcg/kg (maximum dose of 100~     mcg) or similar volume of a placebo solution via an atomizer. Co-administration of oral~     ibuprofen 10 mg/kg (maximum dose of 600 mg) will also be provided to the two groups if not~     received in the previous 4 hours. The primary outcome will be the mean pain rating reduction~     at 15 minutes. The secondary outcomes will be mean pain reduction at 30 and 60 minutes,~     patient's and parental satisfaction levels, percent of being pain free, sedation score,~     immediate and within 72 hours adverse events, additional ED analgesics and other medications,~     length of ED stay, disposition outcomes, hospital admission rate and ED revisit rate within~     72 hours. The primary analysis will use an intention-to-treat approach to compare mean pain~     score reduction between the two groups using a Student's T-test. The sample size of 60~     participants per arm was calculated to have a power of 80% to identify a difference of 10 mm~     in the VAS.~      Expected results : Our study might demonstrate that INF provides additional pain relief for~     children presenting to an ED with headaches. Providing INF could relieve their symptoms more~     quickly, potentially improve patient's and family's satisfaction, possibly reduce the length~     of their ED stay and consequently, have a significant impact on patient quality of care and~     cost-effectiveness.~   "
70934|NCT02638493|"~     Male participants taking tenofovir-emtricitabine (TDF/FTC) will provide semen and blood~     samples which will be analyzed to better understand the pharmacology of antiretroviral~     therapy in the male genital tract.~   "
70935|NCT02638480|"~     The purpose of this study is to evaluate the effect of the KneeMD subject-controlled knee~     rehabilitation device on the incidence of postoperative flexion contracture.~   "
70936|NCT02638467|"~     Patients newly diagnosed with chronic phase chronic myeloid leukemia undergo treatment with~     TK inhibitors (TKI). A possible cause of TK failure is represented by the insufficient~     recovery of normal Ph- hematopoiesis during TKI treatment, with consequent severe cytopenias~     that limit TKI adequate administration. Although rare, this event happens in a proportion of~     4-5% of CML patients. Our hypothesis is to circumvent this peculiar condition by providing a~     normal hematopoiesis from a HLA-matched donor (Human Leukocyte Antigen). The transplant~     procedure is therefore intended in providing a sustained hematopoiesis that will allow an~     early treatment with an adequate dosing of TKI. The transplant procedure planned in our study~     is built on all available evidences to provide the lowest incidence of acute and chronic GvHD~     (Graft-versus-host disease). Therefore, a bone marrow will be the preferential source and a~     GvHD prophylaxis based on Anti-thrombocyte globulin (ATG) and Cyclosporine/Methotrexate will~     be used according to standard current experience in the field of family and unrelated donors.~     The pre-transplant TKI will be continued until aplasia will develop, in order to decrease the~     tumor load as much as possible.The use of TKIs shortly after transplant carries the risk of~     inhibiting the newly transplanted hematopoietic cells, as Kit, an important kinase in normal~     bone marrow cells, is frequently blocked by Abl inhibitors. The use of bosutinib as~     post-transplant therapy is justified by the lack of Kit inhibition that distinguishes~     bosutinib from all other TKIs, and which could allow a minimal inhibitory activity against~     the transplanted normal bone marrow.~   "
70937|NCT02638454|"~     Sarcopenia is a predictor of functional-limitation, leading to loss of independence, lowered~     quality of life, and ultimately death. The impaired ability of aged skeletal muscle to adapt~     to anabolic stimulation may be a factor that contributes to sarcopenia. This project will~     provide novel insights into the role of microRNA in the attenuation of aging skeletal muscle~     to changes in gene expression after anabolic stimulation.~   "
70938|NCT02638441|"~     The aim of this study is to determine the prevalence of psychological affection in infertile~     egyptian women~   "
70949|NCT02638298|"~     This is a study comparing two methods of dressing a post operative wound that are currently~     in practice. One method is a traditional dry gauze dressing. The other method is using a~     negative pressure dressing that provides gentle suction on the wound.~      The investigators will attempt to determine how well the use of post-operative negative~     pressure dressing reduces wound healing problems in patients who have surgery after radiation~     for a sarcoma in the thigh or leg.~   "
70950|NCT02638285|"~     To compare pregnancy rate by Human Chorionic Gonadotropin (HCG) administration and urinary~     Luteinizing Hormone (LH) surge method for insemination in patients undergoing Intrauterine~     Insemination (IUI) at Montaserieh infertility center.~      The present study comprised 309 infertile women candidate for IUI, randomly divided into LH~     surge and HCG groups (assign the number for each patient, odds number for LH and even number~     for HCG group). All patients were subjected to baseline ultrasound and received clomiphene~     citrate before undergoing serial transvaginal sonography. LH was measured using LH kit when~     2-5 follicles (18-20 mm) appeared in LH surge group, and if positive, IUI was performed after~     24 hours. In HCG group, the patients received HCG 1000 units and underwent IUI after 36~     hours. The pregnancy rate was then compared in LH and HCG groups.~   "
70951|NCT02638272|"~     Whether radical debridement is necessary for the treatment of thoracic and lumbar~     tuberculosis is still questionable. The objective of this prospective randomized study was to~     compare the outcomes of radical debridement versus no debridement under different surgical~     procedures for the treatment of thoracic and lumbar tuberculosis.~   "
70952|NCT02638259|"~     Demonstrate equivalent efficacy of GP2015 and EU-authorized Enbrel in patients with moderate~     to severe, active (RA) who had an inadequate response to disease modifying anti-rheumatic~     drugs (DMARD) including methotrexate (MTX).~   "
70953|NCT02638246|"~     Self-management of diabetes can result in long-term benefits, such as delaying or preventing~     the development of a number of unnecessary health complications, and can even reduce the~     chances of premature death. Because adherence to diabetes self-management often declines~     during adolescence, it is critically important to develop interventions that increase~     adherence of diabetes self-management skills in this population.~   "
70954|NCT02638233|"~     Patients with chronic hepatitis C that are under opiate substitution therapy are likely to~     have psychiatric comorbidities such as depression; hence an Interferon based therapy is~     contraindicated. Additionally many of these patients have a borderline compliance, which~     makes it impossible to treat them at specialized hepatological centers. An ideal opportunity~     to treat this patients is treatment with DAAs (Direct Acting Antiviral) which can be~     administered daily together with the opiate substitution therapy at a low threshold facility.~   "
70955|NCT02638220|"~     This is an observational, multicenter study to determine the prevalence of Cerebrotendinous~     Xanthomatosis (CTX) in patient populations diagnosed with early-onset idiopathic bilateral~     cataracts. Patients who are potentially eligible for study participation will be identified~     through a chart review of patients who were seen at each study site prior to that site's~     initiation, or by entering care at the site while the site is participating in the trial.~   "
70956|NCT02638207|"~     Study to evaluate the Efficacy and Safety of Three Different Dosages of NewGam in Patients~     With Chronic Inflammatory Demyelinating Poly(radiculo)neuropathy~   "
70957|NCT02638194|"~     The primary purpose of this study is to examine the health effects of mainstream and~     secondhand hookah (i.e. water pipe) smoke on pulmonary and cardiovascular functions as well~     as serum levels of inflammatory biomarkers. Investigators would like to demonstrate that~     inhalation of both mainstream and secondhand smoke generated by hookah produces adverse~     pulmonary and cardiovascular effects and alterations in serum levels of inflammatory~     biomarkers.~   "
70958|NCT02638181|"~     This study was to assess the distinct expression of matrix metalloproteinase 13,tissue~     inhibitor of metalloproteinases 3, and calcium-sensing receptor, in human trabecular meshwork~     between normal and glaucomatous eyes.The expressions of matrix metalloproteinase 13, tissue~     inhibitor of metalloproteinases 3 and calcium-sensing receptor in the trabecular meshwork~     tissues were examined by streptavidin-peroxidase immunohistochemical staining method and~     western blot, and histological changes of trabecular meshwork were studied by Hematoxylin and~     Eosin staining.~   "
70959|NCT02638168|"~     Over 10% of children in the United States are diagnosed with ADHD, and nearly half of these~     children have moderate to severe impairments in sleep, further exacerbating their already~     impaired academic, emotional and social functioning. In children with ADHD, 34% of prescribed~     sleep medications are antipsychotics that can cause marked weight gain and metabolic changes;~     alternate medications have either been found to be ineffective, difficult to tolerate or are~     largely unstudied in youth. Delayed sleep onset is strongly correlated with active symptoms~     of ADHD and Oppositional Defiant Disorder (ODD), suggesting that better control of disruptive~     behaviors could improve sleep patterns and this application will assess if the extension of~     the therapeutic effects of CNS stimulants into the early evening improves sleep onset.~   "
70960|NCT02638155|"~     The purpose of this exploratory study is to use Electrogastrography (EGG) to measure and~     compare the gastric myoelectrical activity between persons with food addiction (FA) and a~     control group. Additionally, this study will explore if differences exist between perceived~     hunger and satiety and hormone levels related to hunger and satiety in both groups. The~     comparison of the EGG readings and hormone levels is the next step in furthering our~     understanding of food addiction and how the physiology - not simply the symptomatology - of~     FA does or does not relate to weight management.~   "
70961|NCT02638142|"~     DiurHF is a prospective, multicenter, observational, study that compares continuous with~     intermittent infusion of furosemide in patients admitted with a diagnosis of ADHF. Previous~     pilot study design was planned to anticipate a larger multicenter trial able to definitively~     evaluate the optimal loop diuretic use strategy in patients with ADHF.~   "
70962|NCT02638129|"~     The purpose of this study is to evaluate cardiovascular (CV) safety of naltrexone~     hydrochloride (HCl) and bupropion HCl extended release combination (NB) compared with placebo~     and rule out excess risk of major adverse cardiovascular events (MACE) when given in~     combination with standard of care in overweight and obese participants with documented~     history of CV disease.~   "
70963|NCT02638116|"~     The purpose of this study is to evaluate the Effect of Omeprazole on the Pharmacokinetics of~     Ibrutinib in Healthy Adults.~   "
70965|NCT02638090|"~     The main purpose of this study is to see whether the combination of two drugs called~     pembrolizumab and vorinostat can help people with advanced lung cancer. Researchers also want~     to find out if the combination of pembrolizumab and vorinostat is safe and tolerable. This~     study will compare the effects of the combination of two drugs called pembrolizumab and~     vorinostat with the effects of pembrolizumab alone. The U.S. Food and Drug Administration~     (FDA) has approved pembrolizumab for use to treat a deadly skin cancer called melanoma and~     lung cancer and vorinostat to treat some forms of blood and lymph node cancers.~   "
70966|NCT02638077|"~     -  To find out the gap between real-world clinical practice and guideline recommendations~          in initial management of DTC patients~        -  To observe the characteristics of patients who achieved and did not achieve TSH target~          value after one year follow-up~        -  To assess response to initial therapy in patients who undergo total or near-total~          thyroidectomy and RAI remnant ablation after one year follow-up (according to an~          modified dynamic risk stratification system)~        -  To observe the recurrence status after one year follow-up~   "
70967|NCT02638064|"~     Assessment of surgiflo injection for treating pilonidal sinus disease~   "
70968|NCT02638051|"~     This trial studies efficacy and safety of combination of modulated electro-hyperthermia~     (mEHT) with Traditional Chinese Medicine (TCM) in treatment of peritoneal carcinomatosis with~     malignant ascites versus standard chemoinfusion (CDDP+5FU).~   "
70969|NCT02638038|"~     This is a randomized, double-blind, parallel group study comparing two doses of INT131( 3 mg~     and 1 mg) administered orally (PO) daily (QD) versus placebo 1 tablet PO QD in subjects with~     treatment-naïve RRMS for ≤ 3 years.~   "
70970|NCT02638025|"~     This study use anterior segment spectral-domain optical coherence tomography (SD-OCT) to exam~     patients with closed globe injury, and compared with slit lamp examination. The results~     showed that OCT can identify features of closed globe injury that were otherwise not visible~     on slit lamp biomicroscopy.~   "
70971|NCT02638012|"~     Current management strategies for severe and recurrent epistaxis secondary to Hereditary~     hemorrhagic telangiectasia (HHT) include surgical procedures, and uncomfortable nasal~     packing, both of which are often only short-term solutions. Floseal® may provide a~     non-invasive and less painful treatment option for epistaxis in HHT patients. This hemostatic~     agent has been shown to be an effective intraoperative hemostatic agent in a number of~     surgical procedures including endoscopic sinus surgery. It has also been shown to be~     favorable over nasal packing at controlling acute anterior epistaxis. Though the efficacy of~     using Floseal® for epistaxis in HHT patients has been proven anecdotally in the literature it~     has yet to be proven in a prospective clinical trial. The results of this pilot study will~     provide insight into the efficacy of using Floseal® in the management of severe epistaxis in~     HHT patients and to assist in the development of a full-scale prospective clinical trial.~   "
70972|NCT02637999|"~     Randomized open-label substudy of daily Myrcludex B (MXB) plus pegylated interferon-alpha-2a~     (PEG-INF-a) in patients with hepatitis B e antigen (HBeAg) negative chronic hepatitis B virus~     (HBV) co-infected with hepatitis delta virus (HDV).~   "
70973|NCT02637986|"~     Background: Urinary tract infections (UTIs), the most common infection in pregnancy,are~     associated with several maternal and fetal complications, including maternal septic shock,~     preterm labor, intrauterine growth restriction and intrauterine fetal death. Thus, the~     prevention of UTIs in pregnancy is a very important goal. Several studies have suggested that~     alterations in the vaginal flora were associated with recurrent UTIs, and probiotic~     administrations may have a role in preventing those infections. Nevertheless, this has never~     been tested in pregnant women.~   "
70974|NCT02637973|"~     The effects of empagliflozin treatment on hepatocellular lipid content, liver energy~     metabolism and body composition will be investigated in a multicentre, prospective,~     placebo-controlled, double-blind, randomized, 2-arm parallel, interventional and exploratory~     pilot study in patients with newly diagnosed type 2 diabetes.~   "
70975|NCT02637960|"~     This study will investigate the efficacy and safety of fedovapagon in the treatment of~     nocturia in men with BPH.~   "
70976|NCT02637947|"~     The study purpose is to demonstrate that ventricular tachycardia (VT) ablation using the~     Niobe™ ES system results in superior outcomes compared to a manual approach in subjects with~     ischemic scar VT in a low ejection fraction population.~   "
70977|NCT02637934|"~     Up to 30 women with known or suspected epithelial ovarian, fallopian tube, or primary~     peritoneal cancer will participate in two different imaging cohorts. The Biodistribution~     cohort will include up to 10 patients and the Dynamic cohort will include up to 20 patients.~     Human dosimetry will be calculated from the Biodistribution cohort. The Dynamic cohort date~     will evaluate preliminary information on uptake of [18F]FTT in gynecological cancer and~     compare with PARP-1 activity in tissue.~   "
70978|NCT02637921|"~     Bone losses are well known to occur in response to unloading (in microgravity or during~     immobilisation) and in patients with chronic obstructive airway disease (COPD). However, it~     is unknown whether there is an interactive effect between hypoxia and musculoskeletal~     unloading upon bone and mineral metabolism. Fourteen non-obese men, who are otherwise~     healthy, will undergo 3x 21-day interventions; normobaric normoxic bed rest (NBR; FiO2=21%),~     normobaric hypoxic ambulatory confinement (HAMB; FiO2=14%; ~4000 m simulated altitude), and~     normobaric hypoxic bed rest (HBR; FiO2=14%). The effects of hypoxia and bedrest on bone~     metabolism and phosphor-calcic homeostasis will be assessed (before and during each~     intervention, and 14 days after each intervention period) using venous blood sampling, 24hr~     urine collections, and peripheral quantitative computerized tomography (pQCT).~   "
70979|NCT02637908|"~     A training module has been developed for parents to effectively address stressors and demands~     of parenting and promote positive and supportive parent-child interactions. The purpose of~     this study is to implement the parent training program and evaluate the effectiveness of the~     program. Depending on the results, investigators expect core aspects of this module to be~     adaptable and modified or extended for parents of older children in the future to meet the~     needs of families across the stages of childhood development.~   "
71614|NCT02629549|"~     The primary end-point of the study is to determine the specificity and sensitivity of OTL38~     in identifying pituitary adenomas when excited by an imaging probe. The investigators intend~     to enroll 50 patients in this study. The study is focusing on patients presenting with~     suspected pituitary adenomas who are considered to be good surgical candidates.~   "
70980|NCT02637895|"~     Post-traumatic stress disorder (PTSD) can result from having experienced or witnessed a~     traumatic event. Patients with PTSD symptoms can sometimes experience symptom relief after~     treatment with antidepressants; however, few patients experience complete symptom relief.~     There is a need to develop new treatments for PTSD.~      This study will evaluate if 12 weeks of using Vortioxetine relieves PTSD symptoms.~     Vortioxetine has been approved for the treatment of depression; however, Vortioxetine has not~     been approved by the Food and Drug Administration for the treatment of PTSD.~   "
70981|NCT02637882|"~     The patients will exposed to different intervention through three nights (ear plug, eye~     mask). 50 patients in the age range 18- 60 years admitted to ICU of Assiut university~     hospitals will be randomly allocated into into two groups (control group and intervention~     group).~   "
70982|NCT02637869|"~     The investigators are conducting a prospective analysis of the Alternative Payment~     Methodology (APM) demonstration project sites. The investigators' goal is to conduct a cross~     project analysis of findings. The investigators propose to use mixed methods to study~     processes and outcomes associated with the APM natural experiment in payment reform. The~     investigators hypothesize that Community Health Centers (CHCs) participating in the APM~     demonstration project will redesign their workflows to better focus on patient and population~     health needs, resulting in reallocation of financial resources, lower overall costs, changes~     in utilization patterns, and improved quality.~   "
70983|NCT02637856|"~     This study will evaluate the efficacy and safety of ocrelizumab in participants with RRMS who~     have had a suboptimal response to an adequate course of DMT. Participants will receive~     ocrelizumab as an initial dose of two 300-milligrams (mg) intravenous (IV) infusions (600 mg~     total) separated by 14 days followed by one 600-mg IV infusion for a maximum of 4 doses (up~     to 96 weeks). Anticipated time on study treatment is 96 weeks.~   "
70984|NCT02637843|"~     Coronary angiography (CAG) and possible angioplasty (Percutaneous Coronary Intervention =~     PCI) can be performed by access from the groin (a. femoralis), the wrist (a. radialis) or the~     elbow (a. brachialis). It is well established that there is less risk of bleeding~     complications when using a radial access. The smaller diameters of the vessels in the~     forearm, however, may result in increased risk of pain during CAG/PCI via a. radialis. This~     is associated with vascular spasm (spasm tendency). Ultimately this means that one may have~     to convert to access via a. femoralis.~      To perform a CAG/PCI, a tube (a so-called sheath) has to be inserted in a. radialis. It is~     unclear whether the design of the sheaths can reduce the spasm tendency, thus reducing pain.~     Terumo has recently introduced a new kind of sheath, so-called Terumo Glide Slender Heath~     Coated (hereafter referred to as Slender sheath). This sheath is partly coated, partly made~     of a thinner material. Slender sheath thus has an outer diameter smaller than that of the~     sheath from traditional use (Terumo Radio Focus sheath, hereafter referred to as Standard~     sheath), although the inner diameter (lumen) is the same in the two sheaths. In turn, the~     Slender sheath is more fragile and far more expensive.~      The purpose of the present study is to evaluate whether use of slender sheath compared with~     standard sheath is Associated with less pain and fewer complications following CAG/PCI.~   "
70985|NCT02637830|"~     This study mainly compared the response of the artificial carious enamel lesions to~     remineralisation in situ. The tested in vitro demineralising protocols were: MC gel, PA gel,~     MHDP and Buffer solutions.~      The lesions were then remineralised in an in situ model, with crossover and double blind~     design. Fifteen volunteers wore intra-oral appliances containing 2 bovine enamel samples of~     each demineralising protocol during 3 experimental phases (3 days each). The experimental~     phases/treatments were: Control (Placebo dentifrice, saliva effect only), Home-care (fluoride~     dentifrice, 1,100 ppm F, NaF), and Professional/Home-care (varnish- 22,600 ppm F and~     dentifrice- 1,100 ppm F, NaF).~      During the 3-day phase, the appliance was only removed during the main meals (four times a~     day, maximum 1 h duration each, interval between meals 2-3 h). Immediately after the meals,~     before replacing the appliance in the mouth, the subjects were advised to perform oral~     hygiene using a soft end-rounded toothbrush (Colgate® 360º Sensitive Pro-Relief TM) and~     dentifrice (non-fluoridated from IceFresh, Bauru, SP, Brazil or fluoridated dentifrice from~     Crest Procter & Gamble, Cincinnati, OH, USA) according to the phase and dental floss~     (Sanifill, São Paulo, Brazil).~      The remineralising treatment with dentifrices was done ex vivo, 1 min twice a day (after the~     first and last oral hygiene of the day) using slurry of the dentifrice (1:3 water, 1 drop of~     solution/specimen). Thereafter, the appliance was replaced in the mouth and the subjects were~     advised to rinse with 10 ml of water for 5 s and to expectorate. In respect to~     Professional/Home-care phase, the varnish (Duraphat, Colgate, SP, Brazil) was applied before~     the in situ study for 6h and then removed.~      The enamel remineralization was quantified using transverse microradiography (% mineral~     recovery and lesion depth, TMR), surface and cross-sectional hardness. The data were~     submitted to statistical analysis (p<0.05).~   "
70986|NCT02637817|"~     As a common white matter (WM) disease in preterm neonates, punctate white matter lesion~     (PWML) frequently leads to the abnormalities of brain development (e.g. the motor, visual and~     auditory disorders), even to cerebral palsy (CP) and amblyopia during childhood. However, it~     is lack of certain methods in identifying the prognosis of PWML. Through using various~     advanced MRI techniques, neuro-behavioral and visual assessments, a multicenter longitudinal~     study would be conducted to follow-up the PWML neonates with varying spatial-position and~     degree lesions. Through tracking the variations in WM microstructures from neonate period to~     childhood (2 years old and 3 years old), this study aims to explore (1) the potential~     relations between varying PWMLs and motor and visual disorders (2) the relations between WM~     MRI-metrics and neurodevelopmental assessment results, and thus determine the early~     biomarkers to identify CP and amblyopia.~   "
70987|NCT02637804|"~     Clinical evaluation of stenfilcon A compared with narafilcon A and delefilcon A~      This is a total 120 subject, randomized, open label, bilateral wear, two week crossover study~     (each lens for 1 week) evaluating the clinical performance of stenfilcon A spherical lenses~     compared to narafilcon A or delefilcon A spherical lenses.~   "
70997|NCT02637674|"~     Uterus transplantation may enable women with uterine factor infertility to become pregnant~     and give birth.~      This study will explore the feasibility of a uterine transplant and eight subjects will~     undergo deceased donor uterine transplantation at CHU de Limoges.~      There phases involved in this study: Primary, Secondary and Tertiary Screening, Medical~     Evaluation, IVF, Transplantation, Embryo Transfer, Pregnancy/Delivery and Follow up.~   "
70998|NCT02637661|"~     The purpose of this study is to explore the earlobe crease as a risk factor of acute~     myocardial infarction (AMI)in the Chinese population, combined with other risk factors, to~     predict high risk patients with coronary heart disease.~   "
71666|NCT02628873|"~     The study evaluates whether saline infused sonography (SIS) with directed air bubbles for~     hysterosalpingo-contrast sonography (HyCoSy) is as good as or better than X-ray~     hysterosalpingography (HSG) for determining whether fallopian tubes are open or closed in~     patients who are undergoing an Essure confirmation test.~   "
70988|NCT02637791|"~     Stroke is the third most common cause of mortality and the leading cause of long term~     disability worldwide with over 900,000 people living in England who have had a stroke. 75% of~     survivors regain their ability to walk again, however it is estimated that between 55 and 75%~     fail to regain satisfactory use of their impaired arm. This limits the person's independence,~     ability to care for themselves and reduces their quality of life. Research indicates that for~     optimal recovery, high levels of rehabilitation are required yet current provision often~     fails to meet the required levels of intensity and duration of therapy.~      In conjunction with stroke patients, their families and therapists, the team developed a low~     cost system (the virtual glove) to encourage stroke survivors to practice arm exercises at~     home. The system tracks infrared light emitting diodes (LEDs) positioned on the fingers~     turning the hand into a game controller to play games that encourage the movements of reach,~     grasp and release that underlie activities of daily living.~      Before examining its effectiveness, the purpose of the registered study is to determine how~     feasible a large trial would be in terms of whether sufficient participants could be~     recruited, whether they would use the glove and whether outcome measures could be collected.~      Patients will be recruited if they are aged 18 years or over, are recovering from a stroke,~     no longer receive any other intensive rehabilitation but still experiencing difficulty using~     their arm. After baseline measures are collected they will be randomly allocated to either~     the intervention group or a control group. The intervention group will have the virtual glove~     and games at home for a period of eight weeks and be advised to use the equipment for 20~     minutes, three times a day. The control group will continue to have whatever care they are~     already receiving but no new interventions.~      Outcome measures will be collected at baseline, four weeks and after the equipment has been~     removed from their home. Outcome measures will include tests of arm function as well~     participant reports of how often they are using their affected arm and how easy they find~     activities of daily living. The therapists collecting the outcome measures will not know to~     which group the participants have been allocated.~      Once all outcome measures are collected the two groups will be compared on how much their~     final outcome measures differ from those collected at baseline.~   "
70989|NCT02637778|"~     The interventional study will evaluate effectiveness and potential of a 'cardioprotective~     diet' for adults with increased risk for cardiovascular diseases (CVD). The 'cardioprotective~     diet' is characterized by adequate energy intake, intake of carbohydrates, protein and fat~     according to the guidelines of the German Society of Nutrition (DGE e. V.), with special~     focus on fat quality of the foods.~      Half of the participants will consume additional n-3 long-chain (LC)-PUFA (3 g~     eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA)/d). The study participants receive~     defined personal nutritional counselling every two weeks and they get daily menu plans (with~     optimised nutrient profiles) over an entire period of 20 weeks (follow-up 20 weeks).~   "
70990|NCT02637765|"~     This is a prospective randomized controlled trial in which patients with previous breast~     cancer will be randomized into two treatment arms:~        1. Control Group of Usual Physical Activity~        2. Intervention Group of Increased Physical Activity~      No specific intervention will be performed In the patients randomized in the control group.~      Patients randomized in the Intervention group will receive a program of increased physical~     activity starting from 5000 steps/day up to 12000 steps/day after 8 weeks. At the same time~     patients of this group will receive an 8-week recreational program of brisk walking/running~     (3 times a week).~      All the patients enrolled in this trial will receive a pedometer device (Garmin Vìvofit) able~     to count the number of steps, determine a daily goal of steps, determine the covered distance~     (in Km), determine daily caloric consumption, and determine the movements during sleep.~   "
70991|NCT02637752|"~     Background: Childhood obesity imposes a great burden on the healthcare system. Given the~     increased frequency of dental compared to medical visits during childhood, dentists may be in~     an ideal position to recognize patients at risk of developing obesity. This randomized~     clinical trial explored the efficacy of a brief nutrition and physical activity counseling~     for healthy weight 6 to11 year-old children in a university-based pediatric dental clinic.~      Methods: 168 children, 6-11 year old, were allocated to test and control groups and their~     Body Mass index (BMI) were recorded. Their parents/caregivers completed a questionnaire~     regarding their child's nutrition, physical activity and screen time. The parents/caregivers~     of the test group then received a brief counseling session that encouraged an increase in~     children's physical activity, and a decrease in sugar-sweetened beverages and screen time.~     Data, collected at baseline and follow-up session (within 6-12 months) were analyzed using~     general linear regression, adjusting for age, gender, socio-demographic characteristics,~     education, labour force, income and awareness of school nutrition policy (P≤ 0.05).~   "
70992|NCT02637739|"~     About 10% of early pregnancies can not be visualized by transvaginal ultrasound (TVU) on~     first visit and are classified as pregnancy of unknown location (PUL). The etiology includes~     ongoing intra-uterine pregnancy, failing pregnancy, or ectopic pregnancy. Early diagnosis of~     ectopic pregnancy is important because it allows conservative treatment. Serum β-hCG, D&C,~     and laparoscopy are routinely used as diagnostic methods. The purpose of the study is to~     evaluate if the less invasive office hysteroscopy (HSC) can help diagnose PUL.~   "
70993|NCT02637726|"~     In children, only a few studies have compared different modes of propofol infusion during a~     total intravenous anesthesia (TIVA) with propofol and remifentanil. The aim of this study is~     to compare Bispectral Index (BIS) profiles (percentage of time spent at adequate BIS values)~     between four modes of propofol infusion: titration of the infusion rate on clinical signs~     (TIVA0), titration of the infusion rate on the BIS (TIVABIS), target controlled infusion~     (TCI) guided by the BIS either with the Kataria model (TCI KBIS) or the Schnider model (TCI~     SBIS).~      Methods: Children will be prospectively randomized into the 4 groups. In the TIVA0 group the~     anesthesiologist is blinded to the BIS. In each group, the percentage of time with adequate~     BIS values (45-55), the bias and imprecision will be calculated.~   "
70994|NCT02637713|"~     Gastroesophageal reflux disease (GERD) is a frequently seen entity after sleeve gastrectomy.~     Management of GERD after sleeve is difficult given limited treatment modalities. Stretta is~     an endoscopic FDA approved device that improves symptoms of GERD, there is minimal~     information about its use on patients after sleeve. This registry will attempt to get~     information regarding the treatment of reflux using Stretta after sleeve gastrectomy.~   "
70995|NCT02637700|"~     Small fiber neuropathy (SFN) is the most common cause of neuropathic pain in peripheral~     neuropathies, with a prevalence of at least 53/100.000. Patients with SFN may have~     excruciating pain and current anti-neuropathic and other pain drugs do not relief pain~     substantially.~      Several studies suggested an immunological basis in SFN and case studies have reported~     efficacy of treatment with intravenous immunoglobulin (IVIg) in patients with SFN. It is~     therefore conceivable that immunological mechanisms play a role in idiopathic SFN (I-SFN).~     However, to date no randomized controlled study with IVIg in patients with SFN has been~     performed. The aim of the current study is to investigate the efficacy and safety of IVIg in~     patients with I-SFN in a randomized, double-blind, placebo-controlled study.~      The objective of the study is to evaluate the efficacy of IVIg treatment (4 courses of~     treatment, 3 weeks apart) compared to placebo on pain alleviation.~   "
70999|NCT02637648|"~     The purpose of this study is to test the effects of sodium oxybate on headache response~     (frequency), sleep quality and quality of life in the prophylactic treatment of patients with~     chronic and episodic cluster headache. Oral sodium oxybate, 3-9g per night, starting with 3g~     in two nightly dosages of 1.5g and increased by steps of 1.5g every second or third night~     until treatment Response will be evaluated in an interventional, placebo-controlled,~     double-blind, randomised, parallel group, multicentre study. Primary outcome is reduction of~     nocturnal pain frequency Secondary outcomes are improvement of sleep quality at a subjective~     level as assessed by diary and standardized scales (PSQI, FOSQ), duration of pain free~     episodes, general clinical outcome (global evaluation), clinical global impression (CGI-S,~     CGI-I, CGI-E), quality of life (SF 36) and daytime sleepiness (Epworth Sleepiness Score).~   "
71000|NCT02637635|"~     The purpose of this study is to determine if autologous fat transplantation as a~     pre-treatment gives better results in breast reconstruction with implants after mastectomy~     and radiotherapy. One group is randomized to conventional reconstruction with implant and one~     to pre-treatment prior reconstruction with implant.~      Our aims are:~        1. To study whether lipofilling can decrease the number of reoperations and complications~          such as postoperative infections or not.~        2. Evaluate the aesthetic results and the patients' experiences. For both these aims the~          hypothesis is that pre-treatment is in favour for the outcomes.~   "
71001|NCT02637622|"~     In 2012, the FDA Center for Devices and Radiological Health (CDRH) issued guidance to clarify~     the principal benefit-risk factors FDA considers during the reviews for premarket approval~     applications and de novo classification requests. In addition to a detailed description of~     benefits and risks, CDRH listed patient tolerance for risk and perspective on benefit as a~     factor that CDRH may consider in regulatory reviews. It underlined the need for developing~     methods to measure patient preference and incorporate it into regulatory decision-making. The~     purpose of this study is to advance methods for patient and community engagement in~     patient-centered outcome research (PCOR) and has three objectives.~      First, demonstrate good practices for patient and community involvement in PCOR projects by~     applying principles of community-based participatory research (CBPR).~      Second, address methodological gaps pertaining to the use of stated-preference methods in~     studying preferences in PCOR. These include identifying the best methods for designing a~     preference study and strategies for analyzing variation in preferences. The investigators~     also seek to assess the relevance of stated-preference methods to patients and stakeholders~     using both qualitative and quantitative methods.~      Third, demonstrate good practices for applying stated-preference methods by studying the~     preferences of patients with type II diabetes. While type II diabetes provides an important~     case study, this research will advance approaches and methods that will be broadly~     generalizable to other diseases, and to diverse patient and stakeholder groups.~      Clinical Significance:~      This project will illustrate and advance methods for assessing the values of patients and~     stakeholders. It will demonstrate how CBPR methods apply to PCOR studies and the value of~     stated-preference methods in measuring the preferences of patients and stakeholders and~     directing health care.~   "
71002|NCT02637609|"~     In 2012, the FDA Center for Devices and Radiological Health (CDRH) issued guidance to clarify~     the principal benefit-risk factors FDA considers during the reviews for premarket approval~     applications and de novo classification requests. In addition to a detailed description of~     benefits and risks, CDRH listed patient tolerance for risk and perspective on benefit as a~     factor that CDRH may consider in regulatory reviews. It underlined the need for developing~     methods to measure patient preference and incorporate it into regulatory decision-making. The~     purpose of this study is to advance methods for patient and community engagement in~     patient-centered outcome research (PCOR) and has three objectives.~      First, demonstrate good practices for patient and community involvement in PCOR projects by~     applying principles of community-based participatory research (CBPR).~      Second, address methodological gaps pertaining to the use of stated-preference methods in~     studying priorities in PCOR. These include identifying the best methods for identifying~     patient priorities and strategies for analyzing variation in priorities. The investigators~     also seek to assess the relevance of stated-preference methods to patients and stakeholders~     using both qualitative and quantitative methods.~      Third, demonstrate good practices for applying stated-preference methods by studying the~     priorities of patients with type II diabetes. While type II diabetes provides an important~     case study, this research will advance approaches and methods that will be broadly~     generalizable to other diseases, and to diverse patient and stakeholder groups.~      Clinical Significance:~      This project will illustrate and advance methods for assessing the values of patients and~     stakeholders. It will demonstrate how CBPR methods apply to PCOR studies and the value of~     stated-preference methods in measuring the priorities of patients and stakeholders and~     directing health care.~   "
71003|NCT02637596|"~     A prospective clinical study evaluating quality of life (QoL) in pancreatic cancer patients~     treated with intraoperative radiofrequency ablation (RFA).~   "
71004|NCT02637583|"~     The purpose of the present study is to compare the immunological response of pneumococcal~     serotype specific B-cells, the humoral immune response and safety after sequential~     vaccination versus simultaneous vaccination with 13-valent pneumococcal conjugate vaccine~     (PCV13) and 23-valent polysaccharide vaccine (PPV23) versus single vaccination with PPV23 in~     a prospective, randomized controlled monocentric head-to head clinical study in elderly. The~     hypothesis of this study is that simultaneous vaccination with PCV13 and PPV23 might achieve~     an improved immune-response compared to sequential vaccination or single vaccination.~      Adults >=60 years without previous pneumococcal vaccination will be randomized in three~     groups and receive either PCV13 on day 0 plus PPV23 6 months later (sequential vaccination)~     or they receive PCV13 plus PPV23 simultaneous on day 0 (simultaneous vaccination) or they~     receive PPV23 on day 0 (single vaccination). Blood will be taken for pneumococcal~     serotype-specific B-memory cells against four vaccine-serotypes (ST), included in PCV13 and~     PPV23, vaccine-serotype 3 (ST3), vaccine-serotype 14 (ST14), vaccine-serotype 19A (ST19A) and~     vaccine-serotype 23F (ST23F) at visit 1, 2,4,5,7 and 8 and for antibody levels against the 12~     vaccine-serotypes included in PCV13 and PPV23 at visit 1, 3, 4, 6, 7 and 8 in all three~     groups. Adverse events will be recorded for 28 days after each vaccination.~   "
71005|NCT02637570|"~     This study evaluated effect of Hibiscus tea and green tea supplements on athletic~     performance, blood pressure, muscle damage indices and oxidative stress in male athletes~     18-35 years old and cardiovascular disease prevention approach.~   "
71006|NCT02637557|"~     The objectives of this study are to evaluate the safety, efficacy, and dose-response~     relationship of IW-3718 administered orally to patients who have GERD and continue to~     experience GERD symptoms while receiving once-daily (QD), standard-dose PPIs~   "
71007|NCT02637544|"~     Aim of this randomized clinical trial is to examine the treatment effectiveness of an~     acupuncture protocol in adult patients with non chronified TMDs.~   "
71008|NCT02637531|"~     This dose-escalation study will evaluate the safety, tolerability, pharmacokinetics, and~     pharmacodynamics of IPI-549 monotherapy and IPI-549 in combination with nivolumab in subjects~     with advanced solid tumors.~   "
71073|NCT02636686|"~     This is a phase IIIb, multi-centre, open-label extension study in male subjects with DMD who~     previously have been treated with drisapersen, aiming at assessing the safety and efficacy of~     drisapersen.~   "
71074|NCT02636673|"~     Retrospective multi-center comparative chart review of robotic-assisted versus laparoscopic~     sigmoid resection for both benign and malignant disease~   "
71667|NCT02628860|"~     This phase II study is to evaluate the safety and efficacy of Ferinject® in reducing~     perioperative transfusion in iron deficiency anemia patients anticipating~     pancreatoduodenectomy.~   "
71009|NCT02637518|"~     There is a proved strong evidence of the usefulness of frailty as a predictive factor of~     relevant and desired outcomes in populations of older adults. Several studies have been~     published showing the utility of the concept in improving the prognosis accuracy and the~     prediction of different risks (hospitalisations, surgical and non surgical complications,~     length of stay, death, incident disability, etc.) in emergency departments, surgical~     patients, and inpatients with cardiovascular disease. The studies have placed the focus in~     assessing population risk, while the validation process for these instruments as diagnosis or~     screening tools has been usually neglected. FRAILTOOLS aims to assess the usefulness as~     screening and diagnosis tools of some selected instruments to detect frailty in both clinical~     (Hospital and Primary Care) and social (Nursing Homes) settings, providing diagnostic~     algorithms clinically sound. Target groups are all of those older adults at risk of frailty~     (pre-frail) plus those that are frail and are at risk for developing disability. According to~     the published prevalence of these two conditions, the target population concerned by this~     project represents around 40-50% of people older than 65, and 60-70% of people older than 75.~     Once determining the best tools of screening and diagnosis in different settings of care,~     investigators will research conclusions of these people wherever the level of care they need~     and currently use. The benefit will spend to the Health System and Social Care as it will~     provide validated instruments that are necessary to provide an appropriate care for older~     adults by means of a comprehensive, continued, coordinated and integrated care.~   "
71010|NCT02637505|"~     114 patients between 18 and 50 years with an isolated focal cartilage defect in the knee will~     be randomized to either receive arthroscopic microfracture or arthroscopic debridement. Both~     groups will then undergo a systematic physiotherapy training regime for 6-9 months. The~     groups will then be compared for results, after 3, 6, 12 and 24 months, by using validated~     patient reported outcome scores (Lysholm, KOOS, Tegner) and EQ5D as well as clinical~     examination and radiological findings at 2 years (MRI).~   "
71011|NCT02637492|"~     Critical limb ischaemia (CLI) is the most serious stage of peripheral occlusive arterial~     disease (POAD). Despite progress in the revascularization procedures, half these patients~     experience amputation or death after one year. One issue is to identify these subjects~     because aggressive treatment is necessary in those cases, while in others (ie leg ulcer in a~     patient with POAD but no rest lower limb ischaemia), revascularization will not be necessary.~     Then it would be useful to develop a simple score to help the physician to improve diagnosis~     of CLI.~   "
71012|NCT02637479|"~     80% of palliative care cancer patients suffer from severe pain. The management of these pain~     improves the quality of life of these patients. The management of opioid pain refractory to~     date remains a difficulty for caregivers. Hypophysectomy performed to try to control~     hormone-dependent neoplasia also help relieve pain associated with lesions secondary cancer.~     The surgical hypophysialis radio Gamma Knife ® was recently performed on a small number of~     patients. She would have the advantage of reducing the risk of complications compared to~     other techniques and achieve similar analgesic effect on diffuse, or mixed nociceptive pain~     associated with metastases on average in 2 days and would reduce or stop opiates most often~     responsible for side effects impairing the quality of life. The objective of this clinical~     trial, multicenter, prospective, randomized controlled is to evaluate the effectiveness of~     surgical hypophysialis radio for patients in palliative situations with refractory cancer~     pain in opioid level III. The type of pain cancer pain was done in order to optimize the~     recruitment and homogenization of the study population: patients cared for in palliative care~     units are mostly patients cancer (70-80%). This study is therefore part of a palliative~     setting and the results of this test can be extrapolated to other populations of palliative~     patients with refractory pain.~   "
71013|NCT02637466|"~     The purpose of this antidepressant study is to determine the efficacy of vortioxetine on~     depression and cognition in 80 women with breast cancer, and to elucidate~     inflammatory-mediated mechanisms by which depression and its treatment influence cancer~     outcome. Our hypothesis is that effective vortioxetine antidepressant therapy in depressed~     women with breast cancer will attenuate increased intermediate endpoints of inflammation that~     contribute to the pathogenesis of depression, cognitive impairment, and cancer progression~   "
71014|NCT02637453|"~     Pulmonary vein(PV) isolation has become the cornerstone of radiofrequency ablation for AF.~     However, recent reports have clearly shown that the longer the follow-up period, the lower~     the success rate with a single ablation procedure. In 5-year follow-up, the mean success rate~     was only about 45%. The purpose of the study to investigate whether the linear ablation~     perpendicular to the PV ostium on the basis of circumferential pulmonary vein isolation, can~     reduce recurrence rate of AF. All patients will be followed up for 12 months. And fourteen~     days Holter will be performed at the end of follow-up.~   "
71015|NCT02637440|"~     In patients with ST elevation myocardial infarction (STEMI) the treatment goal is~     revascularization of the occluded artery with the use of primary percutaneous coronary~     intervention (PCI). There is a large subset of patients with STEMI who also have significant~     disease in arteries other than the site of occlusion, and away from the culprit artery. It is~     estimated that up to 50% have disease of more than 50% in the non-culprit arteries.~      The evidence on how to treat those patients with multi vessel disease is conflicting. Earlier~     large-scale studies and registries have suggested early and complete revascularization is of~     no benefit or even harmful. More recent studies have showed the opposite of that. The CVLPRIT~     study showed that early complete revascularization or preventive PCI reduced primary endpoint~     of a composite of all cause mortality, myocardial infarction and need for repeat~     revascularization. The benefit was mainly due to reduced repeat revascularization in the more~     intensive intervention group. The PRAMI study showed very similar results as well.~      The use of Fractional flow Reserve (FFR) in deciding complete revascularization has also~     showed conflicting results so far. A previous trial showed that FFR guided intervention post~     STEMI increased MACE. This was conflicted with more recent study, which showed FFR guided~     complete revascularization improved outcome when compared with more conservative treatment of~     ischaemia driven intervention.~      In this study, the investigators are going to assess the issue of staged revascularization~     guided by FFR or by angiogram, compared to the standard treatment of ischaemia driven~     revascularization~   "
71016|NCT02637427|"~     The purpose of this study is to evaluate prophylactic fresh frozen plasma transfusion in~     patients with moderately elevated international normalized ratios (INR) prior to undergoing~     an invasive procedure.~   "
71017|NCT02637414|"~     This protocol proposes a well-being program, delivered through an application for mobile~     devices, based on meditation and positive psychology principles such as human development,~     the improvement of virtues, quality of life and well-being. The investigators hypothesize~     that this program offered in mobile application may promote well-being and reduce stress~     related problems in the participants.~      Objectives: To evaluate the effectiveness of a well-being program delivered through an~     application for mobile devices in a sample of employees who work in a company (Natura~     Inovação/Cosméticos) and in a hospital (Hospital Israelita Albert Einstein).~      Methods: Two hundred and fifty employees from Natura Inovação/Cosméticos and 250 employees~     from Hospital Israelita Albert Einstein will be recruited. The participants will be~     randomized in two groups of 125 participants each one, half of them in the control group (GC)~     and the other half to the intervention group (GI), by institution.~   "
71018|NCT02637401|"~     Bipolar Disorders (BD) typically involve repeated episodes of both depression and excessively~     high mood or irritability (hypomania or mania). BD presents considerable challenges for the~     individual, his or her supporters, and society more generally. Medication is generally~     considered to be the mainstay treatment, however a substantial number of individuals with BD~     continue to experience episodes despite use of medication. Furthermore, ongoing mood~     instability either outside of episodes, or as the main feature of their BD, is a significant~     difficulty experienced by many. Whilst studies suggest that certain psychological therapies~     can be helpful for people experiencing full bipolar episodes, or to reduce risk of future~     episodes, there are no evidencebased psychological therapies available for individuals~     experiencing ongoing mood instability. Dialectical Behaviour Therapy (DBT) was developed~     several decades ago as an approach for people with Borderline Personality Disorder. DBT aims~     to give individuals who experience rapid and intense shifts in affect skills for managing~     this. Despite the many similarities in the symptoms experienced by individuals with~     Borderline Personality Disorder and those with Bipolar Disorder only a small number of~     studies have tested DBT for BD, and no studies to date have specifically investigated DBT as~     a means to help individuals with ongoing mood instability. We have developed a version of~     groupbased DBT that draws upon our own research to adapt standard DBT for this client group~     (DBTBD).~      The group is designed to be delivered efficiently within the U.K. healthcare system whilst~     meeting the needs of individual participants through use of additional individual sessions~     and a mobile phone application. The current study investigates how acceptable DBTBD is to~     clinicians and patients, and whether - for the small number of individuals in the study~     -changes in symptoms and key ways of thinking and behaving appear to take place across the~     period of treatment.~   "
71019|NCT02637388|"~     The purpose of this study is to address the effect of consuming 4g of soluble fibre~     beta-glucan at breakfast on satiety and food intake.~   "
71020|NCT02637375|"~     Based on preclinical data implicating GR, AR, and JAK/STAT activation as potent mechanisms of~     breast cancer cell survival despite chemotherapy administration (i.e. chemotherapy~     resistance), the study will test a novel approach for improving chemotherapy effectiveness by~     adding Hsp90 inhibition to antagonize the anti-apoptotic signaling pathways that are~     initiated via GR, AR, and JAK/STAT activation.~   "
71021|NCT02637362|"~     A randomised trial comparing three analgesic strategies for patients undergoing forefoot~     surgery in a day-surgery setting.~   "
71022|NCT02637349|"~     The POST's public health impact is likely to be substantial because it will improve cancer~     survivorship planning, which is currently an important deficiency in cancer care recognized~     by the Institute of Medicine and the American College of Surgeons.~      The POST may have many potential benefits for patients such as:~        1. improved long-term health outcomes;~        2. improved psychosocial outcomes and quality of life;~        3. smoother transitions back into old and new life roles; and~        4. improved continuity and coordination of care between providers.~      Most importantly, the POST's influence may reach beyond the patients it directly serves as it~     could help scientists and health care providers understand the potential benefits of cancer~     survivorship planning and how to best design and implement survivorship planning when~     patients are ending treatment for cancer.~   "
71023|NCT02637336|"~     The aim of this study was to evaluate the acute cardiovascular responses in hypertensive~     individuals, in waking and sleeping periods after application of different~     non-pharmacological therapies for the control of blood pressure (BP). Randomly and random~     volunteers held a session of each therapy: Acupuncture, aerobic exercise, essential oil~     inhalation, and session control with a minimum interval of 72 hours between them. On the day~     of sessions the volunteers did not use antihypertensive medication. The variables measured in~     the survey were the blood pressure and heart rate variability (HRV). Descriptive statistical~     averaging procedures, standard deviation and standard error of mean were adopted. Two-way~     ANOVA for repeated measures was performed post-hoc Tukey. The level of the study significance~     was set at p <0.05.~   "
71024|NCT02637323|"~     The objectives of this study were to characterize the local extent and duration of exposure~     of TA from FX006 and TCA IR, characterize the systemic PK of FX006 and TCA IR, and assess the~     safety and general tolerability of a single 5 mL IA injection of 32 mg FX006 relative to 40~     mg of TCA IR in patients with OA of the knee.~   "
71025|NCT02637310|"~     A multi center, randomized, double-blind, placebo-controlled, parallel, phase 2b clinical~     trial to evaluate the efficacy and safety of N02RS1 in patients with acute bronchitis~   "
71026|NCT02637297|"~     This randomized pilot clinical trial studies hypnotherapy in treating chronic pain in cancer~     survivors. Hypnotherapy is a state of concentration and focused attention which can provide~     more control over the experience of acute and chronic pain and its impact and may provide~     comfort, maximize function, and improve quality of life in cancer survivors.~   "
71027|NCT02637284|"~     Phase I clinical trial in healthy volunteers to study safety and pharmacokinetics of BPC-157,~     a pentadecapeptide from gastric source.~   "
71028|NCT02637271|"~     In order to better understand how commonly used dietary interventions for obesity influence~     brain activity and in turn people's ability to adhere to their healthy nutrition plan, the~     investigators need to study how people's brains react to food cues while undergoing such~     interventions. Our study will add to our understanding of neural (brain) regulation of~     hedonic and homeostatic mechanisms (i.e. pleasure and hunger) in influencing adherence to~     calorie-reduced eating plans.~   "
71075|NCT02636660|"~     This study will allow us to determine the perceived Health-Related Quality of Life (HRQL) a~     year after ICU discharge, and compare it with HRQL measured earlier on in the process, as~     well as analyse the negative experiences they had while in the ICU and as a result of MV and~     their impact over time. It will also allow us to assess the effect of Nursing Sensitive~     Outcomes and ICU stressors on health-related outcomes and how they affect HRQL.~   "
71076|NCT02636647|"~     Randomized, open-label safety, tolerability study with exploratory endpoints and~     pathophysiological evaluation of the FMT~      Two groups of outpatients with cirrhosis will be randomized using random sequence generator~     into no-treatment and FMT groups.~   "
71029|NCT02637258|"~     This study is designed as a multicenter, prospective, cohort clinical study. The out of~     hospital cardiac arrest (OHCA) patients presenting to the adult emergency departments of the~     participating hospitals will render the study population. The non-traumatic, non-intracranial~     event related OHCA patients in whom the return of spontaneous circulation (ROSC) is achieved~     will render the sampling group.~      The primary aim of this study is to evaluate the relationship of bedside ultrasound (USG)~     measurements of Optic Nerve Sheath Diameter (ONSD) following the ROSC after Cardiopulmonary~     resuscitation (CPR) for OHCA patients, with early (3rd day) neurological evaluation and 30~     days survival rate, proposing that increased ONSD may be related to negative neurological~     outcomes. Considering a relationship is found, the secondary goals of the study are~     established as, identifying a cut-off value for ONSD related to negative neurological outcome~     and the optimal time to measure ONSD.~      The sampling size with a power of 95% is calculated to be 203 patients. The patients whose~     available next of kin has given consent will be admitted to the study.~   "
71030|NCT02637245|"~     Diabetic macular edema (DME) is the most common cause of vision loss in diabetic patients.~     While anti-VEGF treatments and to a lesser extent corticosteroid and macular photocoagulation~     have improved outcomes in patients with DME, no single therapy is universally effective and~     currently there is no a priori means of determine which patients will respond best to any~     given therapy. The purpose of this study is to determine whether specific parameters of~     ocular imaging studies including optical coherence tomography and fluorescein angiography can~     predict response to treatment in patients with DME. This is a prospective observational~     cohort study that will collect clinical data and imaging studies obtained as standard of~     care. Up to 150 subjects with clinically significant DME will be enrolled at Duke Eye Center~     or its satellite offices. These imaging studies will be analyzed to determine whether~     specific parameters are associated with poor or favorable response to specific treatments.~     There will be no intervention as part of this observational trial, thus the primary risk to~     subjects is loss of confidentiality, which will be minimized by the study team.~   "
71031|NCT02637232|"~     The aim of the study is to evaluate the level of satisfaction among patients to whom Mirvaso®~     / Onreltea TM (trade mark) is prescribed.~   "
71032|NCT02637219|"~     The purpose of this study is to determine whether the response of the immune system to~     bacterial components differs between patients with severe COPD compared to those with less~     severe COPD.~   "
71033|NCT02637206|"~     GSK2894512 is a novel anti-inflammatory agent that is currently under development for the~     topical treatment of atopic dermatitis and chronic plaque psoriasis. This study will be a~     Phase I, single-center, randomized, partial-blinded (evaluator blinded) study which consists~     of two parts (Part 1 and 2). Part 1 of this study will assess skin irritation following a~     single application of GSK2894512 cream at 2 concentrations (e.g. 0.5% and 1%) and placebo by~     simple-patch test and photo-patch test under semi-occlusive conditions in 20 healthy Japanese~     volunteers. Part 2 of this study will assess skin irritation following repeat application at~     0.5% and 1% of GSK2894512 cream and placebo for 7 days under non-occlusive condition in 6~     healthy Japanese volunteers. The study will have Screening visit which will occur within 30~     days from the Day 1 visit of each part. Eligible subjects will be able to participate either~     of Part 1 or Part 2. Subjects will visit the site on Day -1, and hospitalized until the end~     of all assessments on Day 4 (Part 1) or Day 7 (Part 2). Subjects will re-visit the site on~     Day 8 (Part 1) or Day 15 (Part 2) for follow-up assessments. This study will be the first to~     evaluate the safety, tolerability and pharmacokinetics of GSK2894512 cream after single and~     repeat application in Japanese subjects. Results from this study will enable further clinical~     investigation in the Japanese population.~   "
71034|NCT02637193|"~     The purpose of this study is to demonstrate a lack of effect of venlafaxine (Effexor XR) on~     QTc intervals relative to time matched placebo in healthy volunteers~   "
71035|NCT02637180|"~     This is multiple center, prospective study aiming to investigate the tracking and outcome of~     patients attending Greek General hospitals with low-trauma fractures. Secondary end-points~     were to facilitate the implementation of coordinated, multi-disciplinary models of care for~     secondary fracture prevention, and to monitor osteoporosis treatment initiation, osteoporosis~     treatment persistence at 12 months, compliance, and subsequent fractures.~   "
71036|NCT02637167|"~     The objective of this trial is to study the effect of targeting the gut microbiota in~     patients with heart failure (HF). First, the investigators will characterize gut microbiota~     composition in patients with various degree of systolic HF as compared with healthy controls.~     Second, the potential impact of targeting gut microbiota to improve HF will be investigated~     through an open label randomized controlled trial (RCT) of probiotics, antibiotics and~     controls. The hypothesis being tested is that the gut microbiota is altered in HF; that gut~     microbiota of HF patients, through interaction with the intestinal and systemic innate immune~     system, contribute to a low-grade systemic inflammation as well as metabolic disturbances in~     these patients; and that an intervention with probiotics and the non-absorbable antibiotic~     Rifaximin attenuates these inflammatory and metabolic disturbances and improves heart~     function through modulation of the gut microbiota.~   "
71037|NCT02637154|"~     This study investigates the effect of motivational interviewing and intensive education on~     HbA1c values and glucose variability in poorly controlled adolescent T1D patients.~      In the present study motivational interviewing (MI) will be integrated to clinicians' daily~     practice, as a part of normal clinical visit. In this randomized, controlled trial hypothesis~     is, that applying motivational interviewing during regular clinical visits results in better~     acceptance and subsequently enhanced metabolic control in adolescents with poorly controlled~     type 1 diabetes.~   "
71038|NCT02637141|"~     Protocol CELIM-NRCD-001 is designed to be a Phase 2a, randomized, double-blind,~     placebo-controlled, parallel-group study to evaluate the efficacy and safety of AMG 714 for~     the attenuation of the effects of gluten exposure in adult patients with celiac disease~     during a gluten challenge.~   "
71039|NCT02637128|"~     This study was designed to determine the efficacy of both artemether-lumefantrine and~     artesunate-amodiaquine (but not to compare the efficacies of the two drugs) for the treatment~     of uncomplicated Plasmodium falciparum malaria at Machinga, Nkhotakota, and Karonga District~     Hospitals- Malawi.~   "
73962|NCT02598765|"~     The purpose of this study is to determine the reduction in intraocular pressure and~     cumulative incidence of complications between the standard and micro trabeculectomy surgeries~     3 months after surgery.~   "
71040|NCT02637115|"~     Overweight and obesity have reached worldwide epidemic level. Both overweight and obesity are~     characterized by comorbidities such as cardio-metabolic risk factors (i.e., insulin~     resistance, type 2 diabetes, hypertension, dyslipidemia, low-grade inflammation) representing~     a major public health problem. Therefore, it is urgent to find a therapeutic solution to~     target all these metabolic disorders. Among the environmental factors able to influence the~     individual susceptibility to gain weight and to develop metabolic disorders associated with~     obesity, more and more evidence show that the trillions of bacteria housed in our~     gastro-intestinal tract (i.e, gut microbiota) influence host metabolism. The investigators~     recently discovered a putative interesting microbial candidate, namely Akkermansia~     muciniphila (Akk). More exactly, we found that the administration of Akkermansia muciniphila~     reduced body weight gain, fat mass gain, glycemia and inflammatory markers in diet-induced~     obese mice. Moreover, in overweight/obese patients with cardiovascular risk factors subjected~     to a calorie restriction diet (calorie restriction diet for 6 weeks and an additional 6 weeks~     of weight maintenance), a higher abundance of Akkermansia muciniphila was associated with a~     better cardio-metabolic status in these patients. The investigators also discovered that~     patients having more Akkermansia muciniphila in their gut before the calorie restriction~     exhibited a greater improvement in glucose homoeostasis, blood lipids and body composition~     after calorie restriction. These observations suggested that the administration of~     Akkermansia muciniphila in overweight or obese people could be a very interesting therapeutic~     solution. Currently, no human study has investigated the beneficial effects of Akkermansia~     muciniphila administration on obesity and metabolic disorders. The overall objective of this~     study is to evaluate the effects associated with the administration of live or heat-killed~     Akkermansia muciniphila on the metabolic disorders (insulin-resistance, type-2 diabetes,~     dyslipidemia, inflammation) related to overweight and obesity in humans.~   "
71041|NCT02637102|"~     CAVIAR is a multicentre prospective observational study. Centres for cardiac and vascular~     surgery assess and manage patients in different ways before surgery. Some centres have~     introduced the use of intravenous iron therapy for patients with anaemia in the preoperative~     setting. Consequently regional variation exists in the assessment and management of patients~     before cardiac and vascular surgery. We aim to observe and measure these differing pathways~     and observe if there is variation in iron deficiency and anaemia and the impact of these~     variables on patient cardiorespiratory function as well as post-operative outcomes.~      [Sub-Study] For patients who are receiving intravenous iron therapy as part of their routine~     clinical care, we wish to observe this effect in more detail. We will assess the impact of~     the treatment on well-being, blood count and fitness. Information will be collected through~     Quality of Life questionnaires, total haemoglobin mass test (via blood collection) and~     fitness testing.~   "
71042|NCT02637089|"~     Parkinson's disease (PD) is known for its motor symptoms and affects more than 100,000~     Canadians. However, PD patients also show cognitive deficits and neuropsychiatric problems~     that significantly impair their quality of life. The occurrence of dementia in PD is much~     higher than in the general population. The proposed study will allow the principal~     investigator, his team and his collaborators to investigate the origins and evolution of the~     cognitive and neuropsychiatric symptoms. Participants with PD with and without mild cognitive~     impairment (MCI) and participants with and without MCI over the age of 60 years will be~     assessed during eight study visits over three years. Through brain imaging, clinical testing,~     as well as genotyping the cognitive patterns in the four different groups will be observed~     and compared. The results will be used to identify biomarkers that can predict the occurrence~     of dementia early in the disease. Ultimately, the results of the proposed research will~     contribute to interventions and treatment strategies tailored to different cognitive profiles~     in PD before the occurrence of dementia.~   "
71043|NCT02637076|"~     The overall aim of this investigation is to establish whether an action of Xyrem® on the~     brain dopamine system in patients with narcolepsy, and in a comparison control group, might~     explain part of the anti-narcoleptic effect of the drug.~      Trial Objective is to establish, using positron emission tomography (PET), in Xyrem®-naïve~     narcolepsy with cataplexy patients, and in matched controls, whether a single dose of Xyrem®~     causes changes in striatal binding of 11C-raclopride and 11C-DTBZ that would suggest altered~     activity of brain dopamine neurones.~   "
71044|NCT02637063|"~     This project will develop and evaluate an interactive blood pressure self-management program~     for adults with prehypertension. The program will target blood pressure self-monitoring and~     the five proven lifestyle modifications recommended by JNC-7: weight reduction, the Dietary~     Approaches to Stop Hypertension (DASH) diet, sodium reduction, physical activity, and alcohol~     consumption.~      The multi-modal program uses a combination of brief motivational health coaching, periodic~     engagement emails, and a robust interactive website to motivate people to take charge of~     their blood pressure management before they require medication. All program components were~     designed to conform to the underlying principles of motivational interviewing. Key program~     components include the use of email and Web-based social networking, personal stories, and a~     brief motivational coaching session to engage participants and encourage intrinsically~     motivated behavior changes. Self-assessment and tracking tools are combined with educational~     content to help participants align their daily lifestyle choices with their personal goals.~      The Phase I prototype program promoted moderate physical activity and eating fruits and~     vegetables as part of the DASH diet. Results from the within-group (n = 39) evaluation showed~     moderate-to-large effect sizes for pre-to-post change in motivation, preparation behavior,~     self-efficacy, attitudes, and knowledge, and a small significant increase in physical~     activity. Participants gave the online program high ratings on satisfaction and usability,~     and reported improvements in confidence, readiness, clarity, change strategies, and interest~     in visiting the Website as a result of the coaching session.~      The fully developed Phase II product will be evaluated in a large randomized trial (N = 450)~     with a 3-month intensive intervention, a 3-month maintenance intervention, and a 3-month~     follow-up period. The Phase II trial is expected to show reductions in blood pressure and~     improvements in JNC-recommended health behaviors. These changes in the outcome measures are~     expected to be mediated by changes in knowledge, attitudes, self-efficacy, behavioral~     intention, motivation, and patient activation.~   "
71045|NCT02637050|"~     The aim of the registry is the assessment of the diagnosis and treatment of CTEPH (Chronic~     Thromboembolic Pulmonary Hypertension) in EMEA (Europe/Middle East/Africa) countries.~   "
71046|NCT02637037|"~     This is a bioequivalence study to compare 2 fixed-dose combination tablets of~     dapagliflozin/metformin XR manufactured at 2 different plants in healthy subjects under~     fasting and fed conditions~   "
71047|NCT02637024|"~     This is a multi-centre randomized phase II trial in women with invasive carcinoma of the~     breast with negative axillary nodes or Ductal Carcinoma In-situ (DCIS) treated by Breast~     Conserving Surgery (BCS). Eligible, consenting patients will be randomly allocated to receive~     radiotherapy of 3 Dimensional Conformal Radiation Therapy (3DCRT) Accelerated Partial Breast~     Irradiation (APBI) 30 Gray (Gy) in 5 daily fractions of 6Gy or 27.5Gy in 5 daily fractions of~     5.5Gy over one week. Patients will be followed at 12, 24, 36 and 60 months post~     randomization. Cosmetic outcome will be measured using photographs and evaluated by a panel~     of trained radiation oncologists. Radiation toxicity will be assessed using National Cancer~     Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).~   "
71077|NCT02636634|"~     The purpose of this multicenter study is to assess a diagnostic strategy concerning~     differential diagnosis between radiation necrosis and relapse in brain metastases treated~     with radiosurgery. Two non-invasive tests - positron emission tomography (PET) with~     1F-fluoro-ethyl-tyrosine (FET) and magnetic resonance spectroscopy (MRS) - will be compared~     to histology in a cohort of patients presenting growing lesions 6 months after radiosurgical~     treatment.~      The results of this study should help to earlier diagnosis of recurrences after radiosurgery~     and to perform an appropriate treatment for patients.~   "
71048|NCT02637011|"~     The purpose of the DACAPO study (Surviving ARDS: the influence of quality of care and~     individual patient characteristics on quality of life) is to investigate the role of quality~     of care and individual patient characteristics on quality of life and return to work in~     survivors of ARDS (acute respiratory distress syndrome). It is hypothesized that higher~     quality of care is associated with better health-related quality of life and a higher rate of~     return to work among survivors.~      A prospective, observational, multi-centre patient cohort study is performed in Germany,~     using hospitals from the ARDS Network Germany as the main recruiting centres. It is~     envisaged to recruit 2400 patients into the DACAPO study and to analyze a study population of~     1500 survivors. They will be followed up until 12 months after discharge from hospital.~     Quality of care will be assessed as process quality, structural quality and volume at the~     institutional level. The main outcomes (health related quality of life and return to work)~     will be gathered by self-report questionnaires. Further data assessment includes general~     medical and ARDS-related characteristics of patients as well as sociodemographic and~     psycho-social parameters. Multilevel hierarchical modelling will be performed to analyse the~     effects of quality of care and individual patient characteristics on outcomes, taking the~     cluster structure of the data into account.~   "
71049|NCT02636998|"~     This study is designed to evaluate cognitive function in preadolescents who have different~     body mass indexes.~   "
71050|NCT02636985|"~     Elastography is an imaging of tissue elasticity or stiffness and is currently emerging as a~     mainstream tool for ultrasound-based diagnosis. This compressibility property of materials,~     mathematically expressed as the change in tissue displacement as a function of its distance~     from the compressing device, is known as strain and is the parameter that is imaged in an~     elastogram.~      Elastography has currently shown promising result in differentiating viscoelastic nature of~     various organs, which is a consequence of certain underlying diseases.~      At present, there are limited literatures revealing the application and feasibility of~     ultrasonic elastography in lung lesions. This is essentially important as it may serve as an~     adjuvant to B-mode ultrasound. The investigators aimed at exploring the application and~     feasibility of ultrasonic elastography on lung lesions.~   "
71051|NCT02636972|"~     This is a cross-sectional observational study.~      For participants resident in Adelaide, South Australia.~      The study consists of 3 visits to the Pain and Anaesthesia Research Clinic (PARC), within the~     Royal Adelaide Hospital (RAH).~      A total of 56 participants will be recruited for this study.~   "
71052|NCT02636959|"~     Chronic sinusitis (CRS) is a common inflammatory sinus condition among Canadians. Saline~     irrigation is an effective therapy used in the management of CRS and is a commonly prescribed~     treatment in preoperative surgery for people with this condition. Recently, a study performed~     by a Toronto group in Canada tried to show if there is any significant improvement between~     using high versus low volume saline irrigation to treat CRS. Despite finding a trend, the~     number of people with CRS used in this pilot study was not large enough to conclusively~     declare any difference between the two treatment groups.~      PURPOSE: The purpose of this study is to determine if there is a clinical benefit of high~     volume saline nasal irrigation (HVSI) over low volume saline irrigation (LVSI) in the~     postoperative period in patients with chronic Rhinosinusitis (CRS). This study is part of a~     multicenter collaborative project initiated by Macdonald et al. (20). A sample size of 176~     participants (88 in each condition) is required to achieve data significance. To achieve~     this, our role is to collect data (plus those of four other Canadian rhinology research~     centres) from 20 patients and add our findings to theirs to establish an acceptable and~     significant result. This information would help otolaryngologists, family physicians, and~     other health care professionals recommend the best post-operative SNI (saline nasal~     irrigation) device for their patients with CRS.~   "
71053|NCT02636946|"~     This study will evaluate the intraocular pressure-lowering effect and safety of Bimatoprost~     SR compared with selective laser trabeculoplasty in patients with open-angle glaucoma or~     ocular hypertension who are not adequately managed with topical IOP-lowering medication.~   "
71054|NCT02636933|"~     The PRE-AR project is a longitudinal observational study. The primary objective is the~     assessment of lung function parameters in late preterm preschool children.~   "
71055|NCT02636920|"~     It is an interventional prospective study. The study will assess the intervention of the~     Therapeutic Education to the Patient (TEP) on the quality of life in asthmatic children.~      The patients will be enrolled from the 1st of May 2016 to the 31st of December 2016 in the~     outpatient clinic of Pediatric Allergology & Pulmonology (PAP) of Respiratory Disease~     Research Center (RDRC) within the Institute of Biomedicine and Molecular Immunology (IBIM) of~     the National Research Council (CNR) of Palermo (RDRC-IBIM CNR), Italy.~   "
71056|NCT02636907|"~     This is an open-label, phase II study of BI 695501 to assess handling experience of patients~     with Rheumatoid Arthritis using an autoinjector. The extension phase is to provide patients~     with additional exposure to BI 695501 and to enhance the safety database for this compound.~   "
71057|NCT02636894|"~     Filler study for smile lines in cheek folds~   "
71058|NCT02636881|"~     82 patients aged 18-49 years with an isolated focal cartilage defect in the knee will be~     randomized to either receive autologous cartilage implantation or arthroscopic debridement.~     Both groups will then undergo a systematic physiotherapy training regime for 6-9 months. The~     Groups will then be compared for results, after 3, 6, 12 and 24 months, by using validated~     patient reported outcome scores (Lysholm, KOOS, Tegner) and EQ5D (European Quality of Life 5~     dimensions) as well as clinical examination and radiological findings at 2 years (MRI).~   "
71059|NCT02636868|"~     The primary objective of this study is to evaluate the safety and efficacy of lucinactant for~     inhalation administered as an aerosolized dose in two doses to preterm neonates 26 - 32 weeks~     gestational age who are receiving nasal continuous positive airway pressure (nCPAP) for~     Resipiratory Distress Syndrome (RDS) compared to neonates receiving nCPAP alone.~   "
71089|NCT02636478|"~     One questionnaire has been configured to ask therapy naive and treated patients about their~     travel activities. Travel activities include private and professional traveling. Another~     questionnaire collects medical information.~   "
71090|NCT02636465|"~     The purpose of this pilot study is to determine whether obese adults,obese (BMI>30 kg/m2)~     with obesity hypoventilation or obese COPD-patients do undergo oxygen desaturation under~     flight simulation and if the hypoxic altitude simulation test is as effective as the hypoxic~     chamber test.~   "
71060|NCT02636855|"~     This screening study is intended for men and women at least 18 years of age who have advanced~     solid or hematologic malignancy. The study will assess a subject's human leukocyte antigen~     (HLA) subtype and tumor antigen expression profile. Based on the results, it will be~     determined if a subject is eligible to be considered for Adaptimmune sponsored clinical~     trials testing the safety and efficacy of genetically changed T cells targeting specific~     tumor antigens. No treatment intervention will occur as part of this screening study.~      Upon enrollment, subjects will be required to provide a blood sample for HLA subtype~     analysis. If the results of the analysis match the HLA-A subtypes noted in the inclusion~     criteria and do not express the HLA subtypes that are exclusionary for the available~     interventional clinical trial(s), then the subject will be required to provide either an~     archival tumor specimen or fresh tumor tissue biopsy. The tumor specimen will be screened at~     a central laboratory for the expression (protein or gene) of multiple antigens which may~     include, but are not limited to NY-ESO-1 and/or LAGE-1a and MAGE A10. Based upon the results~     of these diagnostic analyses, if eligible, subjects will be referred to an appropriate~     available interventional clinical trial(s) at the discretion of the Investigator.~      Following screening, tumor samples will be retained by Adaptimmune for the purpose of~     developing and validating in vitro diagnostic (IVD) assay(s) for antigen expression profiling~     which is required for regulatory approval of a new therapeutic product indication.~   "
71061|NCT02636842|"~     The study will determine the safety, tolerability, and pharmacokinetics of aripiprazole~     lauroxil in adults with schizophrenia or schizoaffective disorder.~   "
71062|NCT02636829|"~     The main objective of this study is to measure, in patients with MS or Chronic Inflammatory~     Arthritis (CIA), the correlation between two calcium intake assessment methods: A self~     assessment questionnaire of calcium intake (QALCIMUM®) versus a food survey serving as a~     reference (gold standard) and based on data from CIQUAL *.~      * CIQUAL Data: Nutritional food composition table available on the website of the ANSES~     (National Agency for Sanitary Security of Food, Environment and Labour), published by the~     Observatory of the Nutritional Quality of Foods. This table includes 1500 sheets of 58~     nutritional components. The data is integrated into the software (DATAMEAL) for calculating~     the ingesta parameters at the Nîmes University Hospital.~   "
71063|NCT02636816|"~     The investigators are investigating whether slow administration of carbetocin is tolerated by~     patients better than if it is administered quickly, with respect to side effects such as~     headache, nausea, vomiting and facial flushing.~   "
71064|NCT02636803|"~     The aim of this study is to provide data on the efficacy of oxfendazole against Trichuris~     trichiura at different doses in comparison to the standard single 400 mg dose of albendazole.~     In addition, the study will provide data on oxfendazole efficacy against other common~     nematodes encountered in man (Enterobius vermicularis, Ascaris lumbricoides, Ancylostoma~     duodenalis, Necator americanus).~   "
71065|NCT02636790|"~     The sinus surgical wait list in British Columbia continues to grow. The current wait list is~     beyond what is acceptable by the province's standard; however, this is not likely to improve~     given the budget constraints of the health care system. The outcome of having patients to~     wait longer than medically reasonable for surgery, not only affects the patients' quality of~     life but presents financial difficulties, both directly to the patient, the healthcare system~     and the economy as a whole. Therefore, the investigators need to determine which patients~     need to be prioritized for surgery. The investigators will follow two groups of patients -~     one group from Stanford University who get surgery always before 8 weeks and compare them to~     patients on the VGH wait list which is often more than one year.~   "
71066|NCT02636777|"~     Supported self-management (SM) is one of the key recommendations in management of chronic low~     back pain (CLBP). SM programmes for patients with CLBP have failed to show clinically~     meaningful improvement in pain and disability markers, which potentially reflect the lack of~     treatment matching of SM programmes. Patient selection for a SM programme for patients with~     CLBP is particularly difficult due to lack of extensive research on what predicts SM and its~     change. The overarching purpose of this study is to identify predictors of SM and its change~     over time in patients with CLBP. This study is a prospective non-experimental longitudinal~     study.~   "
71067|NCT02636764|"~     Osteoarthritis is a chronic, multifactorial characterization, which changes in bone~     alignment, cartilage and structures that provide joint stability appear to be strongly~     correlated with the origin of this disease.This project will aim to verify the effectiveness~     of interferential current, short wave and low level laser therapy on an exercise program for~     mobility and pain in knee osteoarthritis. Blind randomized, placebo controlled. Five groups:~     exercise group, exercise group + Ultrasound therapy, exercise group + interferential current,~     exercise group + short-wave diathermy, exercise group + Low level laser therapy. Before and~     after the trial protocol by the following instruments: Western Ontario and McMaster~     Universities osteoarthritis index (WOMAC), numerical scale of pain assessment (END), Visual~     Analogue Scale Fatigue (VAS-F), issue F2.2 Instrument assessment of quality of life of the~     World Health Organization (WHOQOL-100) test sitting and standing + numerical rating pain~     scale, algometry. This project hypothesizes that the inclusion of photothermal and electrical~     agents in an exercise program will provide an improvement in pain, mobility and knee function~     in individuals diagnosed with knee osteoarthritis.~   "
71068|NCT02636751|"~     This pilot single blind randomized controlled trial aims therefore to evaluate the~     feasibility and the impact on pain and disabilities of a telerehabilitation prehabilitation~     program for patients awaiting a total joint (hip or knee) arthroplasty compared to in-person~     prehabilitation or to usual care.~   "
71069|NCT02636738|"~     Prospective, multicenter, single-arm, non-controlled, 60 subjects enrolled and 14 days follow~     up for evaluate the safety and utility of VelaTM XL thulium laser.~   "
71070|NCT02636725|"~     The investigators hypothesize that combination axitinib with pembrolizumab will improve~     progression-free survival relative to historical controls.~   "
71071|NCT02636712|"~     To observe the safety and efficacy of ImageReady™ MR Conditional Pacing System in Chinese~     subjects~   "
71072|NCT02636699|"~     The PEPITES study evaluates the efficacy and safety of Viaskin Peanut 250 µg peanut protein~     to induce desensitization to peanut in peanut-allergic children 4 through 11 years of age~     after a 12-month treatment by epicutaneous immunotherapy (EPIT).~   "
71078|NCT02636621|"~     Introduction: The Upper Airway Resistance Syndrome (UARS) is a sleep disorder characterized~     by airway resistance to breathing during sleep that leads to arousals and daytime sleepiness.~     There are few studies about UARS treatment and there is not any gold standard treatment for~     it yet.~      Objective: Primary: To evaluate the efficacy of oral appliance on improving fatigue in~     patients with UARS. Secondary: Evaluate the effects of treatment with oral appliance (OA) in~     patients with UARS on sleepiness, mood, cognition, quality of life, metabolism and autonomic~     nervous system.~      Methods: Subjects with UARS (Apnea/Hypopnea Index - AHI - ≤ 5 events per hour of sleep and~     Respiratory Disturbance Index - RDI - > 5 events per hour or more than 30% of total sleep~     time with inspiratory flow limitation and with excessive daytime somnolence and/or fatigue)~     of both genders, with body mass index (BMI) lower than 30Kg/m2 and between 25 to 50 years of~     age will be included. Subjects will be randomly distributed in OA group and placebo (without~     treatment). At baseline evaluation, 6 months and 1 year after subjects will be submitted to~     sleep questionnaires, physical exam, otolaryngological evaluation, baseline polysomnography,~     Epworth sleepiness scale, Multiple Sleep Latency Test, fatigue scale, neurocognitive testing,~     autonomic nervous system analysis (heart rate variability) and metabolic evaluation. Mean and~     standard deviation will be used for descriptive statistical analysis if normal distribution,~     and median and percentiles (25%, 75%) for variables not normally distributed. To compare~     treatment groups T test (parametric) and Mann Whitney (non parametric) will be used. For~     adjusted analysis, linear regression analysis will be used.~   "
71079|NCT02636608|"~     The study seeks to provide evidence of the effectiveness and obtain patient reported outcome~     (PRO) and work productivity data of the interferon-free regimen of Paritaprevir~     (PTV)/ritonavir (r) + Ombitasvir (OBV), ± Dasabuvir (DSV), ± Ribavirin in chronic hepatitis C~     virus infected participants.~   "
71080|NCT02636595|"~     The purpose of this study is to evaluate the effect of response to treatment by evaluating~     the percentage of subjects achieving a 12-week sustained virologic response (SVR12) after 12~     weeks of treatment with ABT-493/ABT-530 and to evaluate the safety of the regimen in~     participants with chronic hepatitis C virus (HCV) genotype (GT) 4, 5, or 6 infection.~   "
71081|NCT02636582|"~     This randomized phase II trial studies how well nelipepimut-S plus GM-CSF vaccine therapy or~     sargramostim works in treating patients with breast cancer. Vaccines made from peptide or~     antigen and/or a person's white blood cells mixed with tumor proteins may help the body build~     an effective immune response to kill tumor cells that express breast cancer. It is not yet~     known whether nelipepimut-S plus GM-CSF vaccine or sargramostim is more effective in treating~     patients with breast cancer.~   "
71082|NCT02636569|"~     This research study will test how well two topical medications work to prevent the~     development of non-melanoma skin cancers by reversing certain biomarkers in the skin. This~     study is also looking at the optimal dose of a medication in a small number of people.~     Biomarkers are molecules that are found in the body and inside of cells. Some biomarkers are~     associated with specific diseases such as skin cancer. In this study, two topical medications~     will be evaluated; diclofenac and alpha-difluoromethylornithine (DFMO).~      Diclofenac and DFMO are approved by the Food and Drug Administration (FDA) for other uses. 24~     patients will be enrolled in this study by University of Alabama at Birmingham.~   "
71083|NCT02636556|"~     This study is designed to evaluate the feasibility and safety of concurrent chemoradiotherapy~     for locally advanced thymoma or thymic carcinoma.~   "
71084|NCT02636543|"~     The decree of June 20th 2013 (n° 2013-527) suggests a protocol regarding the transmission of~     information to the relatives after genetic diagnosis of a serious condition. This decree~     includes a specific model of letter that can be sent to relatives by genetic professionals.~     We evaluated the understanding and feelings after the reading of the decree's letter (letter~     A) on patients and the public. A focus group drafted a new version of the letter (letter B)~     through these observations. The two letter models (A vs B) are compared in terms of impact~     through precise items (understanding and feelings) on three populations: patients, public and~     genetic professionals. Assumption is made that the letter B will be preferred to the letter~     A. Overall, we aim at giving a letter formulation accommodating as many people as possible to~     standardize practices.~   "
71085|NCT02636530|"~     Bone responds according to the load placed on it. In this study, investigators want to know~     if exercise that loads the body in exercises, like walking or jogging (Ground Reaction~     Forces: GRF), affects bone differently than exercises that load the joints, like weight~     lifting (Joint Reaction Forces: JRF). Participants will exercise at least 3 times a week for~     6 months. Measures of bone strength and mass, muscular strength, and aerobic fitness will be~     taken at the beginning and the end of the 6 month program. Period blood samples will be taken~     for future analysis of blood markers.~   "
71086|NCT02636517|"~     Fecal Microbiota Transplant (FMT) in pediatric patients with recurrent C. Difficile with or~     without Inflammatory Bowel Disease (IBD)~      The aims of this study are to determine the safety and efficacy of FMT treatment in pediatric~     patients with recurrent or moderate to severe C. Difficile without (through an observational~     study) and with (through a clinical trial) Inflammatory Bowel Disease and to determine the~     effect of FMT on the gut microbiota through the use of 454 pyrosequencing before and after~     transplantation in these patients.~   "
71087|NCT02636504|"~     The objectives of this study are to determine the sensitivity, specificity, positive~     predictive value, negative predictive value, and accuracy of laser Doppler flowmetry in~     determining the vitality of teeth and comparing with those of electric pulp testing and cold~     testing.~   "
71088|NCT02636491|"~     Title: An open-label, three-center, randomized, cross-over study to evaluate the safety and~     efficacy of day and night closed-loop control using the MD-Logic automated insulin delivery~     system compared to sensor augmented pump therapy at patients with type 1 diabetes at home~     Indication: Type 1 Diabetes mellitus using an insulin pump therapy and continues glucose~     sensors The objective of this pilot study is to evaluate the safety and efficacy of 60 hours~     blood glucose control, using the MD-Logic System in individuals with type 1 diabetes at~     patient's home.~      The duration of study participation for one subject is 28-56 days and the overall duration of~     the study is 6 months The participants of the study are patients ≥ 10 years until 65 years~     with Type 1 Diabetes mellitus using and insulin pump therapy and continuous glucose sensors.~      Sample Size n = 45~   "
71093|NCT02636426|"~     Sorafenib is an oral anticancer drug and inhibits multiple protein kinases important for~     tumor growth and metastases, including VEGFR, PDGFR, and RAF kinases. In daily clinical~     practice it is currently used at a dose of 400 mg twice daily in a continuous schedule. In~     this phase I study patients will be treated with a new dosing schedule of sorafenib: i.e. a~     high-dose, pulsatile schedule. The tolerability and safety of this new schedule is examined~     in exposure escalation cohorts based on a target plasma AUC0-12h (area under the curve).~     Exposure escalation cohorts are used instead of conventional dose escalation cohorts because~     the effect of a drug is dependent of its AUC levels and large differences in plasma sorafenib~     AUC0-12h have previously been shown between patients treated at the same dose level. Using~     pharmacokinetic monitoring, the sorafenib dose will be adjusted to a target plasma AUC0-12h.~     The escalation cohorts consist of 3-6 patients per exposure level starting with a target~     plasma sorafenib AUC0-12h level of 25-50 mg/L/h. After the determination of the maximum~     tolerated AUC0-12h, 10 additional patients will be entered into an expansion cohort. In the~     expansion cohort the patients will be treated with a weekly pulse of sorafenib at the maximum~     tolerated AUC0-12h for further assessment of safety and preliminary exploration of efficacy.~   "
71094|NCT02636413|"~     The purpose of this study is to evaluate both the impact of LacTEST on diagnostic thinking~     and on patient management, and its reproducibility (Test-Retest), for the diagnosis of~     hypolactasia in adults and elderly patients presenting with clinical symptoms of lactose~     intolerance.~   "
71095|NCT02636400|"~     Is postoperative IUI better than expectant management in infertile endometriosis patients~     with good prognosis based on their EFI score? (A single centre randomised controlled trial).~   "
71096|NCT02636387|"~     This study assesses if using the medication desmopressin will decrease nightime bedwetting in~     children with sickle cell disease. Half of the children will receive placebo and half of the~     children will receive desmopressin, with the option to prescribe desmopressin as soon as the~     study is completed.~   "
71097|NCT02636374|"~     The purpose of this study is to examine the effects of a guided imagery intervention on~     perceived stress in pregnant adolescents.~   "
71098|NCT02636361|"~     This study will evaluate how quickly the body absorbs, breaks down, and gets rid of the~     different formulations of LY900014. This study will determine how the different formulations,~     when injected under the skin, will affect the blood sugar levels in the body, and how safe it~     is.~   "
71099|NCT02636348|"~     The primary objective of this randomized, double-blind, placebo-controlled trial is to~     determine the efficacy and effectiveness of Ca and vitamin D supplementation provided daily~     throughout Marine Corps recruit training on maintenance of PTH and indices of bone strength~     in Marine Corps recruits. The investigators hypothesize that Ca+D will prevent elevations in~     PTH and result in greater increases in indices of bone strength compared to placebo.~   "
71100|NCT02636335|"~     The purpose of this study is to determine if an exposure to light in the morning has a~     positive influence on self-chosen exercise intensity on a bicycle ergometer in overweight and~     obese patients.~   "
71101|NCT02636322|"~     The goal of this clinical research study is to learn if the combination of rituximab,~     lenalidomide, and ibrutinib, when given alone and with standard chemotherapy (called either~     EPOCH - Etoposide, Prednisone, Oncovin [vincristine], Cyclophosphamide, and~     Hydrodaunorubicin [doxorubicin]; or R-CHOP - Rituximab, Cyclophosphamide, Hydrodaunorubicin~     [doxorubicin], Oncovin [vincristine], and Prednisone), can help to control diffuse large B~     cell lymphoma. The safety of this drug combination will also be studied.~      This is an investigational study. Ibrutinib is FDA approved and commercially available for~     the treatment of certain types of patients (patients with mantle cell lymphoma [MCL] or~     chronic lymphocytic leukemia [CLL] who have received at least 1 earlier therapy, CLL patients~     with certain genetic mutations, and patients with Waldenstrom's macroglobulinemia [WM]).~      Lenalidomide is FDA approved and commercially available for the treatment of MCL in patients~     who have received 2 therapies before, multiple myeloma (MM), and myelodysplastic syndrome~     (MDS). Rituximab is FDA approved and commercially available for the treatment of~     non-Hodgkin's lymphoma and certain types of leukemia. EPOCH and R-CHOP are FDA approved and~     commercially available for their use on this study. The use of all these drugs in combination~     is investigational.~      Up to 60 participants will be enrolled in this study. All will take part at MD Anderson.~   "
71102|NCT02636309|"~     BACKGROUND: Individual approaches at the workplace might not be sufficient to control Work~     Related Musculoskeletal Diseases (WMSDs) since they are multifactorial and refractory cases~     might need an additional rehabilitation program.~      OBJECTIVE: To evaluate multifaceted intervention efficacy to manage the WMSDs.~      METHODS: A Nordic musculoskeletal questionnaire was applied pre and post intervention to~     determine the efficacy of a multifaceted program, including ergonomics, exercise program and~     acupuncture/physical therapy exercises orientation at the workplace in 126 workers of a~     hearing-aid industry. Additionally, a self-perception survey (Likert scale) concerning~     absenteeism, quality of life and work ability helped to evaluate the program that lasts one~     year and ten months.~   "
71103|NCT02636296|"~     The purpose of the present study was to investigate the effects of 12-week Pilates-inspired~     exercise on functional performance in community-dwelling older women.~   "
71104|NCT02636283|"~     This study proposes the use of Entresto (sacubitril/valsartan) to test the effects on pain~     free walking duration on patients with peripheral arterial disease, a condition caused by~     decreased blood flow to the muscles in the legs.~   "
71105|NCT02636270|"~     With this study we want to investigate the pharmacokinetic (PK) effect of a single injection~     of rhIGF-1 in patients with PAPP-A2 mutations compared to heterozygous carriers and healthy~     controls. This will be followed by treatment of PAPP-A2 deficient patients with IGF-1 for a~     period of one year to assess growth velocity. Additionally we want to further describe the~     phenotypic characteristics of patients with PAPP-A2 deficiency.~   "
71106|NCT02636257|"~     To compare the clinical effects between the silicone nasolacrimal intubation under~     nasoendoscopy and dacryocystorhinostomy on patients with lacrimal duct obstruction.~   "
71107|NCT02636244|"~     The purpose of this study is to evaluate the efficacy and safety of SHAPE Gel applied~     topically to adult patients with alopecia areata of the scalp.~   "
71108|NCT02636231|"~     The purpose of this study is to determine whether endostar and IMRT is effective in the~     treatment of locally recurrent nasopharyngeal carcinoma patients compared with IMRT alone.~   "
71109|NCT02636218|"~     Subarachnoid hemorrhage (SAH) or bleeding in the brain as a result of ruptured aneurysm is a~     devastating type of stroke. Many patients who undergo emergent neurosurgery to repair the~     aneurysm and remove the bleeding suffer from complications in their subsequent hospital stay,~     the most frequent and morbid of which is delayed cerebral ischemia (DCI) or small strokes~     resulting from impaired blood flow to certain vital brain centers. This occurs because of~     changes to the brain's blood vessels that occur after the bleed. The arteries can become~     narrow (spasm) or small clots can form within the vasculature that disrupts normal blood~     flow. Patients are left with profound neurologic deficits from these secondary complications.~      Anesthesiologists, neurosurgeons, and intensivists are in need of a way to protect the brain~     during this vulnerable period following aneurysm repair. One drug that may provide such~     protection is ketamine, a compound frequently used in operating rooms and intensive care~     units to provide anesthesia and analgesia. Ketamine works by blocking glutamate receptor ion~     channels that play a pivotal role in promoting brain cell death during strokes by flooding~     the brain with too much calcium and dangerous chemicals. This project is designed to test the~     efficacy of ketamine in protecting the brain following aneurysm repair by using a controlled~     infusion of the drug in the intensive care unit (ICU) when patients return from their~     operation.~   "
71110|NCT02636205|"~     The purpose of this study is to evaluate the use of the Armeo®Spring Pediatric as therapy for~     children with hand and arm weakness. The Armeo®Spring Pediatric is a device that supports the~     weight of the child's arm and uses joystick that helps to play computer games. The child will~     be assessed before and after this therapy. Participating children with upper extremity~     impairments will receive therapy 3x/week for 6 weeks during 30-45 minutes sessions at~     progressively increasing degrees of difficulty. Each child's performance will be tracked with~     regard to time necessary to complete a predetermined number of trials of the activity. The~     standardized assessment tools that will be used are the Assisting Hand Assessment (AHA), Box~     & Blocks test, Jebsen Taylor hand function test, and the Pediatric Evaluation of Disability~     Inventory-Computer Adaptive Test (PEDI-CAT). Data will be analyzed to determine the efficacy~     of this training method.~   "
71111|NCT02636192|"~     The purpose of this study is to compare the incidence of diabetic ketoacidosis (DKA) among~     participants diagnosed with type 2 diabetes mellitus (T2DM) and pair-matched on exposure~     propensity scores for new use of any sodium-glucose co-transporter 2 inhibitors (SGLT2i)~     versus new use of various other antihyperglycemic agents (AHAs), combined as one group.~   "
71112|NCT02636179|"~     Assisted Reproduction Technologies (ART) are increasingly being used worldwide as a result of~     fertility decline likely caused by changes in both environment and social behaviour.~     Considering this large usage, it is important to evaluate the potential risk on the health of~     children conceived using ART.~      According to the literature, children born after ART are more likely to be at higher risk of~     health problems than spontaneously conceived ones. Interestingly, recent studies suggested an~     increase of asthma prevalence in children conceived using In Vitro Fertilization (IVF).~      The purpose of this study is to evaluate the prevalence of asthma in school adolescents from~     a cohort of children born after In Vitro Fertilization (IVF), aged 11-15 years as compared to~     a control group composed of the same age range spontaneously conceived individuals.~      The expected outcome of this study will provide new information regarding these children to~     ART professionals of and to their own families, by focusing on an age range (between 11 and~     15 years) for which very little information is available to date.~   "
71113|NCT02636166|"~     Study volunteers will be required to conduct a home pregnancy test (HPT) at the trial centre~     and provide a sample of urine from the same void for further testing.~      Volunteers will then complete a product usage questionnaire and leaflet comprehension~     questionnaire at site.~      Follow-up information will be required from all volunteers as both additional urine sample(s)~     and pregnancy information to establish true pregnancy status at the study visit.~   "
71114|NCT02636153|"~     The purpose of this study is to investigate the effects of normal diet and low-phosphate diet~     on the level and the circadian pattern of serum phosphate concentration in normal subjects~     and to explore the underlying mechanisms.~   "
71115|NCT02636140|"~     This study will examine the effects of different colors of light on pupil function and~     alertness.~   "
71116|NCT02636127|"~     Systemic Sclerosis (SSc) is an auto-immune systemic disease characterized by vascular damage,~     cutaneous and visceral fibrosis and a dysimmune condition.~      Therapies in this disease remain insufficient and the complications resulting from organs~     involvement lead to strong morbi-mortality.The dermic infiltrate of the patients includes a~     strong proportion of Tcells. T cells and Natural Killer (NK) cells are potentially involved~     in the vascular damage of the SSc. However mechanisms at the onset of this endothelial~     cytotoxicity and its impact on the capacities of regeneration of the endothelial tissue~     remain poorly understood. Fractalkine is at the same time an endothelial membrane-bound~     adhesion molecule and a chemokine which is able to bind CX3CR1 expressed by the immune~     populations. The purpose of the project is to define the role displayed by cytotoxic,~     circulating immune populations of SSc patients in endothelial cytotoxicity as well as the~     role of the axis Fractalkine / CX3CR1 in mediating the interactions between the immune~     cytotoxic cells and the endothelium.~   "
71129|NCT02635958|"~     With, one in three Americans now having a body mass index (BMI) greater than 30, and the~     fastest growing segment of the population having a BMI greater than 40, it is paramount to~     conduct validation of approaches to measure body composition. Currently the dual-energy x-ray~     absorptiometry (iDXA) is the gold standard for measuring the body composition. But it is~     often difficult to perform since it is limited to specific height, weight and BMI's. InBody~     is a tool which uses bio electric impedance to measure the body composition. This study will~     compare both approaches. Validation is necessary as it is clinically quite pertinent to~     accurately assess a patients' body fat percentage, fat free mass, and total body water and~     changes that are occurring with nutritional support.~   "
71141|NCT02635802|"~     Remifentanil is one kind of opiates with strong analgesic effect,which has the rapid onset~     and short lasting duration. Remifentanil usually is used to help reducing the pain of~     patients with mechanical ventilation in ICU. Maybe it can also be used to ease the pain in~     ICU small short time operation.The purpose of this study is to determine (1) whether~     remifentanil is effective in small short time operations in ICU or not, (2) the save range of~     remifentanil in small short time operations in ICU, (3) and the adverse reaction that happens~     in these operations.~   "
71117|NCT02636114|"~     ABSTRACT:-~      Introduction:~      Chronic periodontitis (CP), the commonest type of periodontal disease, it is an infectious~     disease resulting in inflammation within of the tissues supporting the teeth, progressive~     loss of attachment and bone loss. It is closely related to several systemic diseases, such as~     diabetes and cardiovascular disease. The link between periodontal disease and chronic kidney~     disease (CKD) may be due to infection and inflammation. The periodontal inflammatory state~     may increases the chronic inflammation present in CKD, thus decreasing renal function.~     Periodontal therapy may reduce inflammation and improves endothelial function.~      Aim:- To investigate the effect of mechanical non-surgical periodontal therapy on serum renal~     function markers in systematically healthy CP subjects.~      Objectives:- To evaluate the effect of scaling and root planing (SRP) on serum renal function~     markers such as urea, creatinine, bilurubin in systematically healthy CP patient and to~     compare the clinical parameters such as Gingival index (GI), Plaque index (PI), Probing depth~     (PD), Bleeding on probing (BOP), Clinical attachment level (CAL) between test group (TG) &~     control group (CG).~      Materials and Methods: - 51 CP patients; age ranging between 35-60 years was selected.~     Categorized equally into group I and groups II. Group I was test group (TG) included 25~     patients and group II was control group (CG) included 26 patients. The serum levels of renal~     function markers included Urea, Creatinine, Bilurubin were measured. SRP was done in test~     group only. All the parameters were checked at baseline and one month after SRP. Comparisons~     of baseline and value after 1 month among each criterion among each group unpaired-t test and~     comparisons of two groups for each criterion by paired-t test.~   "
71118|NCT02636101|"~     This study aims to describe the patient population treated and the real-life patients'~     experiences with Xamiol®gel in the long term, up to 52 weeks management of body psoriasis~     vulgaris in Russia. The result will increase the knowledge on Xamiol®gel enabling~     dermatologists and patients to optimize its use in the long term management of psoriasis.~   "
71119|NCT02636088|"~     In patients with esophageal cancer, treatment with curative intent can be given to medically~     fit patients without distant metastases. It may consist of chemoradiotherapy or surgery alone~     or in combination. Surgery in combination with chemotherapy is another option. For patients~     who are not medically fit for surgery or with unresectable invasion in adjacent structures~     the only alternative with curative intent is, with current knowledge, definitive~     chemoradiotherapy. In the current study the investigators aim to improve prognosis for~     patients not suitable for surgery. Patients receive treatment with conventional~     chemoradiotherapy (oxaliplatin, fluorouracil and radiotherapy) with the addition of a more~     recently developed drug, an antibody called cetuximab.~   "
71120|NCT02636075|"~     This study investigates if Parathyroid Tissues Anatomic Localizations Are Displaced Downward~     in Parathyroid Hyperplasia Cases or not.~   "
71121|NCT02636062|"~     This study is a non-randomized prospective cohort study that will define the rate of index~     atherosclerotic plaque development in adults with a prior coronary artery calcium (CAC) score~     of 0 given prior CAC zero > 5 years previous. Ancillary testing of serum, whole blood, and~     endothelial dysfunction will be performed to investigate any detectable systemic processes~     that predict CAC development.~   "
71122|NCT02636049|"~     This is a Phase 1, open-label, three-period sequential dosing study being conducted to~     determine the pharmacokinetics of Triferic iron administered intravenously (IV) to healthy~     adults.~   "
71123|NCT02636036|"~     This is a Phase I multicenter, open label, nonrandomized study of enadenotucirev administered~     in combination with nivolumab in subjects with metastatic or advanced epithelial tumors (with~     focus on CRC, UCC, SCCHN and salivary gland cancer) not responding to standard therapy.~   "
71124|NCT02636023|"~     The study Sponsor, Heart Force Medical Inc. (HFM), has developed a patented medical device~     called the SPhENo-CardiographTM. The SPhENo-Cardiograph™ provides a non-invasive assessment~     of the electro-mechanical function of the heart. The electrocardiograph (ECG) represents the~     waveform of the electrical stimulus to the cardiac muscle. The mechanical actions of the~     electrical potentials delivered in the ECG are revealed as the seismocardiograph (SCG). The~     SCG represents the changes in acceleration of the heart during the cardiac cycle. The SCG~     waveform reflects the ultra-low frequency vibrations of cardiac contraction. These low~     frequency vibrations are transmitted through the sternum. Using the point of initiation of~     ventricular contraction on the ECG, the Q wave, with fiduciary points on the synchronous~     seismocardiograph, it is possible to determine timing events of the cardiac cycle. The timing~     events of the cardiac cycle during systole are referred to as Systolic Timing Intervals (STI)~     and comprise the Pre-Ejection Period (PEP) and the Left Ventricular Ejection Time (LVET). The~     PEP is the time from the Q wave to the Aortic valve opening. The Left Ventricular Eject Time~     (LVET) is the time between the Aortic Valve opening and closing. The ratio of PEP/LVET in~     individuals with established heart disease is > 0.42. It is based on the formula described by~     Dr Arnold Weissler and first published in Circulation in 1968 (Weissler et al,1968). Weissler~     et al showed that the PEP/LVET ratio >0.42 are indicative of a lengthening of the PEP with~     some marginal shortening of the LVET. This is indicative of pathology associated with the~     coronary circulation (Ahmed et al, 1972;). This ratio can then be used as part of a~     non-invasive quantitative assessment of cardiac performance (Lewis et al 1977).~      Using the SPhENo-CardiographTM, HFM has developed an algorithm to assess heart health that~     otherwise requires a number of technologies; stethoscope, ECG and Carotid pulse tracing to~     identify the dicrotic notch or Aortic Valve closure.~   "
71125|NCT02636010|"~     This is a national, multicenter, open label single-arm, non-comparative study that will~     determine the efficacy, safety and the changes in selected pharmacodynamics markers of~     MK-3475 monotherapy administered as consolidation therapy in MM patients who have achieved a~     response with a previous treatment but who still display some residual disease.~      For this purpose, 20 MM patients, who have received any treatment of limited duration either~     at diagnosis or at first relapse, and that have achieved a good response (≥VGPR) but with~     persistent residual disease (that is patients in VGPR, non-stringent CR, or MRD+ sCR), will~     be treated with MK-3475 monotherapy administered iv at a dose of 200 mg every three weeks for~     1 year, with a potential expansion of 1 additional year of treatment in case of clinical~     benefit and patient agreement. Efficacy, safety and pharmacodynamic parameters will be~     evaluated to understand the role of this monoclonal antibody in this setting.~   "
71126|NCT02635997|"~     Ibandronate is a third-generation biphosphonate with recognized antiresorptive efficacy by~     several international, randomized, double-blind, controlled trials. These studies have not~     included patients from central america, to the best of our knowledge. Therefore, this~     open-label, uncontrolled study, was set out to assess the clinical effects of a 6-m treatment~     course with Ibandronate plus vitamine D and Calcium on bone mineral density and~     health-related quality of life.~   "
71127|NCT02635984|"~     The objective of this study is to compare the effectiveness of olanzapine added to standard~     triplet therapy (fosaprepitant, ondansetron, and dexamethasone) versus triplet therapy alone~     in preventing chemotherapy-induced nausea and vomiting (CINV) in hematology patients~     receiving highly or moderately emetogenic chemotherapy regimens.~   "
71130|NCT02635945|"~     This study is the second Phase-II trial analyzing efficacy outcomes of PBF-680 in asthmatic~     subjects, following the supportive data from the proof-of-concept trial on the effect of~     PBF-680 on airway hyperresponsiveness to adenosine monophasphate (AMP). The purpose of the~     present study is to provide an assessment on the efficacy of a 5-day treatment course of once~     daily, orally administered, 10-mg PBF-680 doses, to attenuate Late Asthmatic Responses~     (LAR) as a primary efficacy outcome. The study also aims at analyzing the effect of the~     PBF-680 treatment course on airway inflammation-related outcomes including airway~     hyperresponsiveness to AMP at 24 h after allergen bronchoprovocation, plus nitric oxide~     fraction in exhaled air (FeNO) and airway inflammatory cells counts in induced sputum under~     the effect of an additional 10-mg PBF-680 dose on the 6th treatment period day. Overall, the~     study aims at providing evidence on the efficacy of PBF-680 on outcomes, particularly the~     LAR, that are well established to screen valid drugs for asthma maintenance therapy.~   "
71131|NCT02635932|"~     The trapeziometacarpal osteoarthritis is a degenerative or inflammatory joint that affects~     the trapeziometacarpal joint (TMC) of the thumb. Its main symptom is pain that leads to~     difficulty in manual function and decrease the patient's quality of life. Immobilization of~     TMC thumb joint by bracing has been effective in reducing pain and improving function.~     Objective: To compare the effectiveness between day and night functional splint for patients~     with trapeziometacarpal osteoarthritis in improving pain and function~   "
71132|NCT02635919|"~     The primary aim of this study is to conduct a 60-patient feasibility, acceptability, and~     preliminary efficacy study of mSMART (Mobile App based Personalized Solutions and Tools for~     Medication Adherence of Rx Pill), a smartphone application (app) for improving medication~     adherence among substance users. The investigators will compare 2 groups of cigarette smokers~     undergoing a quit attempt with varenicline (Chantix): a) an experimental group using the~     mSMART app on their smartphone and a MEMS Cap (Medication Event Monitoring System, a smart~     pillbox that will a record a date and time-stamped medication event whenever pill box is~     opened and closed, and thus allow for primary measurement of medication adherence) and b) a~     control group using the MEMS Cap and mobile web-based surveys on their smartphone.~   "
71133|NCT02635906|"~     This is a randomized clinical trial with a control group, based on the guidelines of the~     CONSORT 2010. The interventional group will be in a bed rest for two hours after introducer~     removal in patients submitted a coronary arteriography or coronary angioplasty and the~     control group will follow the standard nursing care for four hours.~   "
71134|NCT02635893|"~     This is a randomized, experimental study that examines the physiology of central nervous~     system pathways contributing to the control of bilateral movements in individuals with spinal~     cord injuries and promotes the recovery of lower-limb motor function through the use of~     stimulation and locomotor training.~   "
71135|NCT02635880|"~     To evaluate the safety and efficacy of an investigational version of the Cutera enlightenTM~     laser that offers multiple wavelengths for removal of benign pigmented lesions.~   "
71136|NCT02635867|"~     At present, dentistry aims for conservative treatments with the goal of maintaining as much~     tooth structure as possible. Dental caries remains the most prevalent chronic disease~     worldwide; these lesions can progress rapidly and reach deeper areas of the tooth. The~     carious lesion is considered deep when it goes through the main tissues of the tooth, and it~     can affect the pulp tissue, where the nerve and nutrients of the tooth are located. There are~     many treatment options for deep carious lesions and they vary by the clinical scenario. Vital~     pulp therapy has become a fairly predictable alternative treatment to pulpectomy (root canal~     therapy). The goal of vital pulp capping therapies is to keep the pulp of the teeth vital to~     prevent further interventions such as root canal treatments and complex restorative work.~     There are two main clinical scenarios when treating these lesions, depending on the remaining~     dentin thickness between the carious lesion and the pulp: vital direct and indirect pulp~     capping. Direct and indirect vital pulp therapies are routinely performed using different~     clinical protocols. The clinical protocols are selected based on the remaining dentin~     (between the tooth preparation and pulp) and the restorative materials. There are few studies~     that evaluate pulp capping method in adult teeth (permanent dentition); many studies have~     investigated baby teeth (deciduous teeth). Routine therapies include the using of adhesive~     restorations with and without an intermediate layer of restorative material. Calcium~     hydroxide based cements have been used for pulp capping as an intermediate layer of~     restorative material. More recently a new intermediate layer of restorative material composed~     of resin-modified calcium silicate has been indicated for use on direct and indirect pulp~     capping. The aims of this study are to compare, over a period of 12 months, the~     post-operative sensitivity and pulp vitality of three indirect pulp capping protocols and two~     direct pulp capping protocol in vital teeth. This study will provide the necessary evidence~     to allow clinicians to select the best restorative protocol when treating deep carious~     lesions where indirect and direct pulp capping protocol are needed.~   "
71137|NCT02635854|"~     Some studies have shown that antiplatelets agents could reduce organ dysfunction in septic~     shock in mice and human models. Platelets are actors in immunity and their activation can be~     complicated by tissue damage with vascular occlusions which can lead to organ dysfunction.~     Investigators can hypothesize an increase in platelet activation and in leukocyte-platelet~     aggregates in septic shock.~   "
71138|NCT02635841|"~     Patients with pantothenate kinase-associated neurodegeneration (PKAN) who have completed the~     ApoPharma-sponsored study TIRCON2012V1-EXT and who wish to continue to take deferiprone will~     be offered the opportunity to receive it on a compassionate basis. Patients will be followed~     locally by their own neurologist or other appropriate specialist.~   "
71139|NCT02635828|"~     Postoperative nausea and vomiting (PONV) is a displeasing experience that distresses surgical~     patients during the first 24 hours after a surgical procedure. The incidence of postoperative~     nausea occurs in about 50%, the incidence of postoperative vomiting is about 30%, and in~     high-risk patients, the PONV rate could be as high as 80%. Therefore, the study design of~     this single arm, non-randomized, pilot study assessed the efficacy and safety profile of a~     triple therapy combination with palonosetron, dexamethasone and promethazine to prevent PONV~     in patients undergoing craniotomies under general anesthesia.~   "
71140|NCT02635815|"~     Background & Aims: Non-cirrhotic portal hypertension (NCPH) represents a relatively~     infrequent group of conditions. This work aimed at determining causes of NCPH and evaluating~     the role of some clinical, laboratory, imaging and endoscopic parameters in prediction of~     variceal bleeding in an Egyptian cohort with NCPH.~      Methods: Sixty patients with non-cirrhotic portal hypertension and oesophageal varices were~     included. All underwent complete clinical evaluation, laboratory investigations, Color~     Doppler ultrasonography, platelet count/spleen diameter (mm) ratio and upper gastrointestinal~     endoscopy. Patients were classified into two groups according to variceal bleeding: (1) Group~     I: twenty six patients with history of bleeding or had an attack of bleeding during one year~     follow-up; and (2) Group II: thirty four patients without bleeding.~   "
71142|NCT02635789|"~     The purpose of this trial is to evaluate the efficacy and safety of NPC-12G gel (topical~     formulation of sirolimus) versus placebo gel to facial angiofibroma and other skin lesions in~     patients with tuberous sclerosis complex (TSC)~   "
71144|NCT02635763|"~     As the population ages, the frequency of surgery is increasing proportionally, bringing with~     it the challenge of managing older patients with frequent comorbid diseases and an increased~     risk of complications. Poor postoperative quality of recovery may result in patient and~     family suffering, a prolonged hospital stay, and a greater demand on health care~     resources.The purpose of this study was to evaluate the ultrasound guided percutaneous~     femoral nerve+lateral cutaneous nerve versus lumbar plexus+sacral plexus nerve block~     composite laryngeal mask anesthesia in elderly hip fracture surgery, the application of~     assessing their impact on the postoperative recovery quality.~   "
71145|NCT02635750|"~     Part I:~      To investigate whether and to what extent donepezil affects single dose pharmacokinetics of~     BI 409306~      Part II:~      To investigate whether and to what extent BI 409306 affects the single dose pharmacokinetics~     of donepezil~   "
71146|NCT02635737|"~     This is a single site, single arm, unblinded safety and feasibility cohort study~     investigating the use of magnetic marker seeds to localise breast tumours.~   "
71147|NCT02635724|"~     This study will evaluate the safety, pharmacokinetics and effectiveness of a single dose of~     600 mg IV peramivir in the treatment of elderly subjects with acute uncomplicated influenza~     infection and in subjects with acute uncomplicated influenza infection at higher risk for~     influenza complications. All subjects will receive IV peramivir.~   "
71148|NCT02635711|"~     Objectives: To evaluate the effects of a novel adapted Taekwondo (TKD) training programme on~     skeletal development and motor proficiency in pre-pubertal children with developmental~     coordination disorder (DCD).~      Hypothesis: The TKD group participants will have improved skeletal development and motor~     proficiency outcomes after adapted TKD training compared with the controls.~      Design and subjects: In this prospective, randomised, single-blinded controlled trial,~     approximately 104 children with DCD (6-9 years old) will be randomly assigned to either the~     adapted TKD group (n~52) or the control group (n~52).~      Interventions: Subjects in the intervention group will receive adapted TKD training for 3~     months (one supervised session/week plus daily home training, 1 hour per session), while~     subjects in the control group will receive no TKD training during the study period.~      Study instruments and outcomes: Primary outcome measures: delay in skeletal development and~     motor proficiency will be measured by an ultrasonic bone age system and the Movement~     Assessment Battery for Children, respectively. Secondary outcome measures: eye-hand~     coordination and standing balance will be measured by a computerised finger pointing test and~     the Sensory Organisation Test, respectively (pre-, post- and follow-up measurements).~      Data analysis: Data will be analysed via repeated-measure analysis of (co)variance followed~     by post-hoc tests, if appropriate (alpha = 0.05).~   "
71149|NCT02635698|"~     Compare percent change in loss of body weight between the OPTIFAST program and a food-based~     energy-deficit program~   "
71150|NCT02635685|"~     A cluster randomised study in the primary care setting to evaluate a electronic clinical~     decision tool for stroke prophylaxis in patients with atrial fibrillation.~   "
71151|NCT02635672|"~     Determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD) and~     recommended phase 2 dose (RP2D) of BAY 1251152 in patients with solid tumors and aggressive~     non-hodgkin's lymphoma (NHL).~   "
71152|NCT02635659|"~     Intraileal infusion of nutrients results in a reduction in food intake. A previous study by~     our group showed that both sucrose and casein infusion resulted in an increase in satiety and~     release of gastrointestinal peptides and a decrease in hunger and food intake. Encapsulating~     both nutrients, daily ingestion of this micro encapsulate and hereby releasing them in the~     distal small intestine could result in a chronic ileal brake activation. The obtained~     reduction in food intake and caloric intake could help overweight subjects to lose weight.~   "
71153|NCT02635646|"~     The purpose of the study is to evaluate the effect of a family and interdisciplinary approach~     on individual and family insulin resistance and insulin secretion in patients with~     prediabetes.~   "
71154|NCT02635633|"~     The purpose of this study is to investigate a novel stimulation protocol of repetitive~     transcranial magnetic stimulation (rTMS) for the treatment of unifocal neocortical epilepsy,~     namely continuous thetaburst stimulation (cTBS). As this is a pilot study, the primary~     endpoint is on safety and tolerability of the treatment. However, information on clinical~     efficacy and mechanism of action will also be collected.~   "
71155|NCT02635620|"~     The purpose of this study is to investigate whether changing from conventional smoking to~     electronic cigarettes causes changes in conventional lung function parameters, bronchial~     reactivity, fractional exhaled nitric oxide (FeNO), Carbon monoxide (CO), health effects and~     smoking behaviour.~   "
71156|NCT02635607|"~     The purpose of study is to compare the effectiveness of the Day-5 fixed administration of~     GnRH antagonist versus flexible administration of GnRH antagonist during ovarian stimulation~     in Chinese women with predicted high ovarian response, and the hypotheses is that the number~     of oocyte retrieved in fixed protocol is not inferior to GnRH antagonist flexible protocol.~   "
71157|NCT02635594|"~     Investigation of 4 weeks supplementation with Carnipure® tartrate on endothelial function and~     parameters of recovery after physical exertion.~   "
71158|NCT02635581|"~     The purpose of this clinical trial is to evaluate the osteointegrative potential of the~     Trabecular TitaniumTM and to measure the pattern of changing in bone mineral density (BMD)~     around an uncemented acetabular cup, manufactured in Trabecular Titanium™ , during 60 months~     after surgery.~   "
71183|NCT02635256|"~     Hypofractionated radiosurgery has been investigated in a few trials and appears to be safe~     and feasible.~      Investigators initiated this multicenter phase II prospective trial to analyse feasibility~     (toxicity) of hypofractionated radiosurgery with 5 fractions in patients with localised~     prostate cancer, who are ineligible for the PREFERE trial under the hypothesis that the~     ratio of patients with late toxicity ≥ grade 2 after 1 year amounts 2,8% and is significant~     lower than 17.5%.~   "
71184|NCT02635243|"~     Primary Objective:~      To assess the pharmacodynamic response (PD) of a single subcutaneous (SC) dose of SAR438544~     versus recombinant glucagon in type 1 diabetes mellitus (T1DM) patients under induced~     hypoglycemia.~      Secondary Objective:~      To assess the safety and tolerability and pharmacokinetics (PK) of a single SC dose of~     SAR438544 versus recombinant glucagon in T1DM patients under induced hypoglycemia.~   "
71159|NCT02635568|"~     Legalization of marijuana in Colorado for both medicinal and recreational purposes has led to~     a perception of its safety, which has not been well studied in pregnant or lactating women.~     The psychoactive component of marijuana, delta-9-tetrahydrocannabinol (THC) is lipophilic and~     therefore presumed to be secreted into breast milk. Additionally, the difference between~     modes of consumption (ie. smoked vs. edible) has not been well described in regards to THC~     concentration in breast milk. The purpose of this small pilot study is to describe the~     presence and duration of THC expression in breast milk among women who have evidence of THC~     exposure at the time of labor and delivery or within 72 hours of delivery. The researchers~     hypothesize that women with positive urine drug screen for THC within 72 hours of delivery~     may excrete THC in breast milk for a predicted period of time, and therefore the aim of this~     project is to determine timing to safely return to breastfeeding to decrease infant exposure~     to THC.~      The specific aims are to determine in women who test positive for THC at delivery:~        1. Determine length of time THC and metabolites are detected in breast milk of mothers who~          have a positive urine drug screen at the time of presentation for labor and delivery or~          within 72 hours of delivery.~        2. Determine length of time THC and metabolites are detected in breast milk of mothers with~          postnatal exposure of either ingested or inhaled marijuana, to inform recommendations on~          when to safely return to breastfeeding.~        3. Describe modes of marijuana consumption in women presenting for delivery and correlate~          with THC concentrations and persistence in breast milk.~   "
71160|NCT02635555|"~     At our centre a conventional dose of 12 mg of hyperbaric bupivacaine in combination with a~     short acting opioid fentanyl (to increase block density) and a long acting opioid morphine~     (to provide post-operative pain relief ) is used for spinal anesthesia for cesarean~     section.However, larger doses of local anesthetic drug when used in caesarean section~     commonly cause low blood pressure and requires drugs (vasopressors) to treat it. In our study~     the investigators will standardize the doses of both opioids (fentanyl/morphine) and adjust~     the dose of local anesthetic (bupivacaine) based on the patients height and weight .One of~     the obvious challenges anesthesiologists face is providing adequate anesthesia to the patient~     whilst minimizing harmful side effects. Our primary concern is the low blood pressure as an~     effect of the spinal anesthetic as it is harmful to both mother and the baby. The~     investigators propose that the extent of surgical anesthetic block, which is dependent on~     height and weight in our adjusted dose group, will provide adequate anesthesia for surgery~     and minimise maternal low blood pressure.~   "
71161|NCT02635542|"~     The investigators will conduct a prospective, randomized trial to assess the impact of~     neuromuscular blockade on early (<72 hours post-ICU admission) postoperative respiratory~     complications in cardiac surgical patients. The study will compare continual neuromuscular~     blockade with cisatracurium to a single dose of succinylcholine during general anesthesia for~     cardiac surgery.~   "
71162|NCT02635529|"~     Amniotic membrane may be considered as a biologically active scaffold, which in combination~     with Bone Replacement Grafts (BRG) can be widely used to reconstruct periodontal Intrabony~     Defects (IBDs), due to the presence of stem cells and growth factors. The goal of the present~     study was to evaluate if a biologic AM in combination with DFDBA applied in periodontal IBDs~     would enhance the regeneration of periodontium.~   "
71163|NCT02635516|"~     This is a proof-of-concept study designed to demonstrate whether increases in cerebral blood~     flow, improvements in brain functioning, and reductions in symptomology associated with~     traumatic brain injury (TBI) can result from treatments consisting of near-infrared~     phototherapy (NIR).~   "
71164|NCT02635503|"~     The purpose of this study is to compare the safety and efficacy of laparoscopic resection~     with natural orifice specimen extraction versus conventional laparoscopic surgery for sigmoid~     colon or rectal cancer.~   "
71165|NCT02635490|"~     The present study aims to investigate the relative efficacy, safety and risk of a single-dose~     prophylaxis in otherwise healthy adult patients undergoing ureteroscopic procedures for~     ureteral stones.~   "
71166|NCT02635477|"~     A multicenter prospective randomized clinical trial testing the hypothesis that a~     patient-centered actigraphy intervention will result in increased physical activity for frail~     older adults increase during the critical first 30 days after a cardiovascular~     hospitalization.~   "
71167|NCT02635464|"~     The study is designed to assess the safety and efficacy of allogeneic human umbilical~     cord-derived mesenchymal stem cells (hUC-MSCs) with injectable collagen scaffold transplanted~     into patients with chronic ischemic cardiomyopathy.~   "
71168|NCT02635451|"~     To study the association between maternal serum vitamin C concentration in women with preterm~     premature rupture of membranes (PPROM) and women without PPROM.~   "
71169|NCT02635438|"~     The objectives of this study are to compare the efficacy and safety of Clotrimazole troche/~     lozenges USP, 10 mg (Unique Pharmaceutical Laboratories, India) vs. Clotrimazole Troche/~     Lozenges USP, 10 mg (Roxane Laboratories Inc., USA) in patients with oropharyngeal~     candidiasis, where this condition has been diagnosed by clinical examination and confirmed by~     fungal culture~   "
71170|NCT02635425|"~     The purpose of this study is to evaluate the effect of single ovarian puncture to retrieve~     7eggs only in prevention of severe ovarian hyperstimulation syndrome.~   "
71171|NCT02635412|"~     This is a randomized controlled trial to investigate the optimal timing of delivery in~     clinically stable women with a suspected morbidly adherent placenta.~   "
71196|NCT02635074|"~     This phase I trial studies the side effects and best dose of ibrutinib when given together~     with idarubicin and cytarabine in treating patients with acute myeloid leukemia that has~     returned after a period of improvement or has not responded to previous treatment. Ibrutinib~     may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~     Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop~     the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Giving ibrutinib together with idarubicin and cytarabine may~     kill more cancer cells.~   "
71197|NCT02635061|"~     Determine the safety, tolerability, dose limiting toxicities (DLTs), and maximum tolerated~     dose (MTD) of ACY 241 in combination with nivolumab.~   "
74003|NCT02598232|"~     This study aims to evaluate the efficacy and safety of the 1,414nm Nd:YAG laser system~     (ACCUPLASTI) added to Percutaneous Epidural Neuroplasty (PEN), a conventional treatment, to~     alleviate back pain in a lumbar herniated intervertebral disc patient.~   "
71172|NCT02635399|"~     Surgical resection in periampullary cancer using pancreaticoduodenectomy is the most~     important modality in the treatment. In the past, pancreaticoduodenectomy was associated with~     high morbidity and mortality. However, with the advances in techniques, including~     perioperative patient management, development of antibiotics, diagnostic radiology, and~     interventional treatments, pancreaticoduodenectomy is now considered a safe and feasible~     operation. Postoperative complication rates are reported to be in 10 to 20% in experienced~     hospitals and operation related mortality is at about 1%. Therefore, surgical treatment for~     periampullary cancer is actively considered.~      However, postoperative complications, such as postoperative pancreatic fistula, (POPF)~     delayed gastric emptying, intraabdominal abscess, and postoperative bleeding, are still~     serious complications. Among these complications, delayed gastric emptying is considered less~     critical. However, delayed gastric emptying (DGE) can cause poor oral intake, which in turn,~     may lead to delay in recovery of postoperative nutritional state and in severe cases,~     requires insertion of levine tube and long-term fasting.~      There have been many hypotheses for cause of DGE after pancreaticoduodenectomy, but definite~     cause have not been discovered yet. With the introduction of pylorus-preserving~     pancreaticoduodenectomy (PPPD), incidences of DGE were initially reported to have increased.~     However, results of most randomized comparative studies had concluded that PPPD and PD have~     no significance in occurence of DGE.~      One hypothesis for cause of DGE we present here has to do with anatomic positioning of~     anastomosis site, especially pancreatojejunostomy (PJ) and duodenojejunostomy (DJ), after~     PPPD. Reconstruction after PPPD positions PJ and DJ close to each other. PJ site is often~     associated with one of postoperative complications, POPF. POPF may create inflammation around~     PJ site and pancreatitis, which may lead to severe adhesion around PJ as a secondary change.~     This adhesion and inflammation may cause DJ, which is located near PJ, to be pulled towards~     PJ site. When DJ is pulled towards PJ site, distal DJ site can become angulated and gastric~     contents may not beadle to pass easily. Gastric contents may be stagnated in stomach and~     thereby causing DGE. Therefore, in this study, we will fixate DJ on transverse colon using~     sutures, and prevent possibility of angulation of DJ. This additional procedure may reduce~     occurence of DGE.~   "
71173|NCT02635386|"~     This is a randomized, single-blind, parallel 5 treatment group 24-week trial designed to~     directly compare the therapeutic effects of exenatide once weekly (EQW), dapagliflozin~     (DAPA), EQW plus DAPA, combined DAPA/metformin extended release (XR) and the weight loss~     medication, phentermine/topiramate extended release (PHEN/TPM ER) on metabolic and~     endocrinological parameters in overweight/obese non-diabetic women with PCOS. In this study,~     we will examine the efficacy of these therapies on metabolic parameters, body weight and body~     composition, anthropometric measurements, and reproductive function in a well-defined group~     of pre-menopausal overweight/obese, non-diabetic women with PCOS, focusing on their~     relationship to insulin resistance and obesity. We hope to determine which treatment(s)~     addressing the multifaceted disturbances of individual subgroups emerge as the preferable~     therapy.~   "
71174|NCT02635373|"~     Observational, registry, prospective, non-interventional collection of CUA patient data.~     Patient treatment is carried out within clinical routine, at the discretion of the physicians~     and according to existing treatment guidelines. Participating physicians will not be subject~     to any instructions with regard to the diagnosis and therapy of their patients.~   "
71175|NCT02635360|"~     The purpose of this study is to evaluate the safety and effectiveness of immunotherapy in~     combination with chemotherapy and radiation (chemoradiation) for the treatment of advanced~     cervical cancer. Pembrolizumab, a type of immunotherapy called a checkpoint inhibitor, will~     be administered after or during chemoradiation.~   "
71176|NCT02635347|"~     This study will assess the feasibility of lower limb-ischemia induced Remote Ischemic~     Conditioning (RIC) in the perioperative period before, during, and after Orthotopic Liver~     Transplantation (OLT). Remote ischemic conditioning will consist of 3 cycles of 5 minutes of~     lower limb ischemia induced via a mid-thigh pneumatic tourniquet, followed by 5 minutes of~     reperfusion. Interventions will take place after anesthesia induction but before surgery, at~     the completion of the procedure, and on the mornings of post-operative days 1-4.~   "
71177|NCT02635334|"~     This is a pilot study of the effect of montelukast in subjects with asthma who are 65 years~     old and older. Montelukast is a leukotriene receptor antagonist U.S. F.D.A. approved for the~     treatment of asthma in subjects who are 12 month old and older. This study is being done~     because there has been no placebo controlled study of montelukast focused on this group of~     patients. Elderly asthmatics have been mostly ignored in asthma studies. They are more likely~     to be underdiagnosed, undertreated, and hospitalized for asthma when compared to younger~     asthmatics. The pathophysiology of asthma in the elderly is typically different than in~     younger patients. This is a double-blind, placebo-controlled, crossover study. Investigators~     plan to enroll thirty subjects who have been diagnosed with asthma for at least one year, are~     non smoker, and did not smoke for more than 10 pack/year of tobacco products in their~     lifetime. After a run-in period of one week, the study subjects will take montelukast 10 mg~     orally for 8 weeks first and then placebo for 8 weeks, or vice versa. Primary objectives of~     this study are to evaluate the effect of montelukast on asthma symptoms assessed by daily~     symptom scores, the Asthma Control Test and the number of puffs of albuterol, and spirometric~     values (FEV1). Secondary objectives include studying whether montelukast affects peripheral~     blood eosinophils counts and serum IgE levels.~   "
71178|NCT02635321|"~     Limb girdle muscular dystrophies (LGMD) are a very heterogeneous group of muscle disorders~     characterized by muscle weakness and atrophy of the proximal muscles of the shoulder and~     pelvic girdles. LGMD is classified based on its inheritance pattern and genetic cause into~     more than 31 different types.~      A new type - type 2T has been found. The genetic cause of type 2T is mutations in Guanosine~     Diphosphate (GDP)-mannose pyrophosphorylase B (GMPPB). Mutations in GMPPB can also cause~     Congenital muscular dystrophies (CMD). Only 41 patients with mutations in GMPPB has been~     reported.~      In this study, the investigators examine five new cases with the LGMD phenotype. The primary~     aim is to examine the muscle involvement using MRI.~   "
71179|NCT02635308|"~     This study evaluates the feasibility of implementing a unilaterally biased high-intensity~     resistance training to facilitate restorative vs. compensatory recovery after usual care~     physical therapy among older adults who have recently incurred a hip fracture. Additionally,~     physical performance during a sit-to-stand task, muscle function (strength/power), physical~     function measures, muscle composition, and muscle quality (force/unit area), are assessed~     before and after targeted high-intensity resistance training.~   "
71180|NCT02635295|"~     The aim of this study is:~        1. to evaluate the effectiveness of the nursing student - nurse teacher mobile cooperation~          (MC) during the clinical practicum,~        2. to measure the usability of the mobile application.~      The detailed research questions and hypothesis of this study are as follows:~        1. What is the impact of MC on the nurse competence level of nursing students evaluated by~          work role, teaching-coaching and therapeutic interventions?~           H1: Nursing students' using MC will have a stronger change in the self-assessed level of~          nurse competence than those using standard cooperation (SC).~           H2: Nursing students' using MC will have higher level of nurse competence assessed by~          mentors after clinical practicum than those using SC.~        2. What is the impact of MC on the clinical self-efficacy level of nursing students?~           H3: Nursing students' using mobile cooperation will have a stronger change in the~          self-assessed level of self-efficacy in clinical performance than those using standard~          cooperation.~        3. What is the impact of mobile cooperation on the satisfaction level of nursing students~          evaluated by supervisory relationship, pedagogical atmosphere on the ward and the role~          of nurse teacher?~           H4: Nursing students' using mobile cooperation will have higher level of satisfaction~          with the supervisory relationship, pedagogical atmosphere on the ward and the role of~          nurse teacher after clinical practicum than those using standard cooperation.~        4. What is the perceived usability of the mobile application by the intervention group?~      The ultimate goal is to establish a modern, innovative solution for the nursing student -~     nurse teacher cooperation to support and facilitate the clinical learning of nursing students~     during the clinical practicum.~   "
71185|NCT02635230|"~     The optimal antithrombotic therapy for patients with atrial fibrillation (AF) with a~     CHA2DS2-VASc score ≥1 with concomitant acute coronary syndrome (ACS) or revascularisation by~     percutaneous coronary intervention (PCI) with stenting, is still unknown. For these patients~     current North American and European guidelines recommend a triple therapy strategy, including~     vitamin K antagonists (VKA), aspirin and clopidogrel. A major drawback of this triple therapy~     strategy is a significant increase in the risk of major bleeding. Furthermore, the ommitance~     of aspirin and the introduction of more potent P2Y12 inhibitors as well as the non-vitamin K~     oral anticoagulants (NOAC), created numerous new antithrombotic treatment strategies for~     these patients with overlapping conditions. To date, evidence on the risks and benefits of~     these new antithrombotic treatment strategies is lacking.~      The WOEST 2 Registry aims to improve medical care for patients with AF and/or a heart valve~     prosthesis ánd undergoing coronary revascularisation through a better understanding of their~     demographics, antithrombotic management and related in-hospital and long-term outcomes. The~     WOEST 2 Registry will provide data to support benchmarking of antithrombotic treatment~     patterns and patient outcomes.~      Objective: To assess the different management patterns and related in-hospital and long-term~     safety and efficacy outcomes of combined use of chronic oral anticoagulation and a P2Y12~     inhibitor in patients with atrial fibrillation and/or a heart valve prosthesis undergoing~     coronary revascularisation.~   "
71186|NCT02635217|"~     Upper endoscopies (Esophagogastroduodenoscopies-EGDs) as well as a lower endoscopies~     (Colonoscopies) are routinely performed by gastroenterologists to assess the lining of~     patients' upper and lower gastrointestinal tracts using a video endoscope (a long tube with a~     video camera on the end). An EGD is performed to examine the upper digestive tract to look~     for areas of inflammation, ulcerations, or other abnormalities in the swallowing tube,~     stomach, or duodenal lining. Similarly, a colonoscopy is performed to directly visualize the~     large bowel for polyps, inflammation, or other abnormalities in the lower bowel lining.~      During these procedures, room air is routinely used to insufflate (expand/inflate the stomach~     and the colon) to allow for better viewing of the lining of the upper and lower~     gastrointestinal tracts; however, recently the use of carbon dioxide (CO2) (instead of air)~     has been shown to possibly have less post-procedure patient discomfort. Additionally, when~     both procedures are performed in the same day, it is currently unknown as to which sequence~     of procedures is better overall -whether to perform the EGD before colonoscopy or vice versa.~      The overall aim of our research is to compare patients' comfort, total amount of sedation~     used, and overall satisfaction with the procedures between four randomly allocated groups, to~     see which method of insufflation and which procedural sequence is better when both procedures~     need to be performed in the same day. We hypothesize that in patients requiring same day~     endoscopies, performing an EGD prior to Colonoscopy with carbon dioxide (CO2) used as an~     insufflator is the best tolerated sequence associated with decreased sedation use and~     increased patient satisfaction/comfort.~   "
71187|NCT02635204|"~     This study will compare the efficacy and safety of DFD-06 Cream to Vehicle Cream for topical~     treatment of moderate to severe plaque psoriasis after 3, 7, and 14 days of treatment.~   "
71188|NCT02635191|"~     This study is designed to compare the eradication rates，safety and compliance of tailored~     therapy to those of standard triple therapy in children with H. pylori infection. The primary~     purpose is to compare the eradication rates of children with H. pylori infection treated with~     tailored therapy to those treated with standard triple therapy. The secondary purpose is to~     evaluate the safety, compliance and factors that might affect eradication rates.~   "
71189|NCT02635178|"~     Obsessive-compulsive disorder (OCD), characterized by recurrent obsessions and/or~     compulsions, is a disabling psychiatric condition affecting approximately 2-3% of the~     population. Whereas several first-line treatments have been established (e.g.,~     pharmacological and psychological), a substantial proportion of patients (40-60%) fail to~     experience symptom remission, underscoring the need for research in this area. One approach~     to increasing treatment efficacy is to target underlying risk factors or dysfunctions that~     may in turn improve outcomes. One such risk factor is anxiety sensitivity (AS) cognitive~     concerns. AS cognitive concerns reflects fears of mental incapacitation (e.g., It scares me~     when I am unable to keep my mind on a task). There is recent evidence that AS cognitive~     concerns is uniquely associated with various obsessive-compulsive (OC) symptom domains.~     However, questions remain as to whether reductions in AS cognitive concerns will lead to~     subsequent reductions in OC symptoms. The purpose of the proposed study is to investigate the~     efficacy of a brief AS cognitive concerns intervention on reductions in OC symptoms.~   "
71190|NCT02635165|"~     Optimize the management of polytraumatises with flail chest: surgical treatment Stracos by~     decreasing the length of stay and the late complications: pain chronicles, quality of life,~     respiratory function~   "
71191|NCT02635152|"~     The purpose of this study is to determine whether a computerized intervention designed to~     reduce appearance and evaluation related interpretation biases will reduce symptoms~     associated with body dysmorphic disorder.~   "
71192|NCT02635139|"~     Aim of the study is to investigate the impact of meal skipping (breakfast or dinner skipping)~     on the regulation of glucose metabolism and macronutrient balance (protein/fat/carbohydrate~     intake vs. -oxidation). An isoenergetic diet with 3 conventional meals (breakfast, lunch,~     dinner) serves as a control.~   "
71193|NCT02635113|"~     The purpose of this study is to develop an abnormal gait detection algorithm and a vibratory~     stimulation system on a lower limb to improve gait stability and prevent falls. The~     investigators want to detect, assess and communicate fall risk indicators obtained via the~     shoe sensors, and assess effectiveness of a gait synchronized vibration system to the plantar~     surface in reducing fall risk.The system consists of a gait measurement module, an abnormal~     gait detection module, and a vibratory stimulation module.~   "
71194|NCT02635100|"~     Obstructive sleep apnea (OSA) is a prevalent disorders characterized by intermittent~     obstructions of the upper airway during sleep. Continuous Positive Airway Pressure (CPAP) has~     been shown to be the most efficacious treatment for OSA. It consists of a small device that~     provides positive airway pressure delivered by a mask attached to the patients nose/mouth.~   "
71195|NCT02635087|"~     The investigators discover the investigators' miRNA tool can be a useful tool to predict the~     patients with stage II colon who can benefit from chemotherapy.Then the investigators plan to~     make an observation study that may validation this tool.~   "
71198|NCT02635048|"~     Percutaneous nephrolithotomy (PCNL) has been considered as the first-line choice for the~     management of >20mm kidney stones. The traditional nephrostomy tract of PNL was dilated to~     24-30F, which is referred to as Standard-PCNL. Standard PNL has an ideal stones free rate~     (SFR), however, at the cost of severe morbidity. To decrease the disadvantages related to~     standard PNL, mini-perc or mini-PCNL, 20F or less, was first introduced to pediatric~     procedure in 1997, and subsequently implemented in adults with the expectation of similar SFR~     and low morbidity in the past twenty years. Although abundant efforts have been done, whether~     mini-perc outweigh standard-PNL for the treatment of >20mm calculis in terms of efficiency~     and safety remains controversial.~      To solve this problem, we performed this multi-center randomized controlled trial (RCT).~   "
71199|NCT02635035|"~     The primary purpose of this study is to test the efficacy of Lisdexamfetamine in Adults With~     Attention Deficit Hyperactivity Disorder (ADHD) and Sluggish Cognitive Tempo (SCT). This is a~     placebo controlled, cross-over clinical trial of oral Lisdexamfetamine Dimesylate 30-70mg/day~     in adults with attention-deficit hyper-activity disorder and Sluggish Cognitive Tempo (ACT).~     Patients will be assigned either LDX/Placebo for 10 weeks with a two week placebo washout~     period.~   "
71200|NCT02635022|"~     Aims: (1) to Establish the FLS services at the National Taiwan University Hospital Jinshan~     Branch. (2) To establish a anti-osteoporosis medication management service at Jinshan Branch.~      Method: From Aug., 2015, a fracture liaison services (FLSs) following the 13 'Capture the~     Fracture Best Practice Standards' were implemented at the National Taiwan University Hospital~     Jinshan Branch health care system. The Jinshan Branch program enrolled patient with 1) new~     hip fracture 2) newly identified vertebral fractures (radiological or clinical) from both~     inpatients and outpatients. At the same time, a osteoporosis medication management service is~     also establish as a complement of FLS to enroll patients on antiosteoporosis medications~     (AOMs) but not necessary with fracture.~      Participating physicians will select those eligible for services and refer to study~     coordinators. Study coordinators will conduct baseline assessments on osteoporosis/fracture~     risks, record medical conditions, AOMs, provide educations on osteoporosis, fracture,~     sarcopenia, fall, medications, nutrition, and exercise. They also arrange return clinic~     visit, telephone reminder and follow up for patients, and communicate with providers on~     regular bases.~      During the whole study period, the investigators planed to enroll 200 patients (with or~     without fracture). Each patient would be assessed at baseline, and every 4 months last for~     two years.~   "
71201|NCT02635009|"~     This randomized phase II/III trial studies how well whole-brain radiation therapy works and~     compares it with or without hippocampal avoidance in treating patients with small cell lung~     cancer that is found in one lung, the tissues between the lungs, and nearby lymph nodes only~     (limited stage) or has spread outside of the lung in which it began or to other parts of the~     body (extensive stage). Radiation therapy uses high energy x-rays to kill tumor cells and~     shrink tumors. The hippocampus is part of the brain that is important for memory. Avoiding~     the hippocampus during whole-brain radiation could decrease the chance of side effects on~     memory and thinking. It is not yet known whether giving whole-brain radiation therapy is more~     effective with or without hippocampal avoidance in treating patients with small cell lung~     cancer.~   "
71202|NCT02634983|"~     The purpose of this study is to assess global ventilated lung volume in moderate to severe~     COPD patients using MRI lung imaging after 8 days of treatment with QVA149 compared to~     placebo.~   "
71203|NCT02634970|"~     There are limited prospective data regarding the potential benefit and risks associated with~     switching between anti-VEGF therapies in patients with nAMD who have initially achieved a~     favorable response to the first anti-VEGF therapy used but subsequently have evidence of~     increasing disease activity despite continuation of therapy. This study will fill this~     knowledge gap by prospectively evaluating the effectiveness and safety of switching from~     aflibercept to ranibizumab in nAMD patients that have non - sustained response to initial~     treatment with aflibercept.~   "
71204|NCT02634957|"~     Absolute voice rest is commonly prescribed after vocal fold surgery, also known as~     phonomicrosurgery, for benign vocal fold lesions. This is thought to decrease scarring of~     vocal folds, which could result in increasing tissue stiffness and limitations in optimal~     vocal outcome. Unfortunately there is no standardized protocol as to how long patients should~     rest their voice after phonomicrosurgery. To date, there are no studies in the literature~     directly comparing the impact of short-term and long-term voice rest on vocal fold healing~     and voice outcome after phonomicrosurgery.~   "
71205|NCT02634944|"~     The purpose of the proposed project is to determine if the VOMS is an effective screening~     tool to identify and track recovery of vestibular and ocular motor impairment and symptoms~     following mTBI, that corpsman-level medical personnel can successfully implement in combat~     and non-combat environments. A second purpose of the project is to determine if impairment~     and symptoms on the VOMS is more pronounced following blast compared to blunt mTBI.~   "
71206|NCT02634931|"~     The purpose of this trial is to evaluate the safety and efficacy of long-term treatment with~     NPC-12G gel (0.2% sirolimus gel) to angiofibroma and other skin lesions in patients with~     tuberous sclerosis complex in the open-label trial.~   "
71214|NCT02634827|"~     This phase II trial studies how well midostaurin and decitabine work in treating older~     patients with newly diagnosed acute myeloid leukemia and FLT3 mutations. Midostaurin and~     decitabine may stop the growth of cancer cells by blocking some of the enzymes needed for~     cell growth.~   "
71215|NCT02634814|"~     The focus of this project is to use transcutaneous electrical nerve stimulation (TENS) for~     the novel indication of treating neuromuscular activation in individuals with knee~     osteoarthritis (OA) that exhibit neuromuscular activation deficits. The overall goal is to~     improve outcomes associated traditional therapeutic exercise (TE) by developing an enhanced~     rehabilitation strategy, which augments TE with TENS (TENS+TE), for the purpose of treating~     underlying neuromuscular activation deficits. The investigators seek to use TENS to excite~     neural pathways that immediately increase neuromuscular activation as well as cause sustained~     improvements in neuromuscular activation and greater strength gains in knee OA patients~     compared to traditional TE. The investigators will evaluate the effect of TENS+TE on muscle~     strength, neuromuscular activation, gait biomechanics, physical function, physical activity,~     self-efficacy of physical activity, self-reported quality of life, disability and pain. The~     central hypothesis is that an enhanced TENS+TE intervention will lead to better clinical~     outcomes, increased physical activity, and improved general health. The rationale for~     conducting a small clinical trial, which demonstrates the feasibility and establishes the~     preliminary effects of an enhanced rehabilitation strategy, is ultimately to inform the~     development of a future larger clinical trial to establish the efficacy of an enhanced~     rehabilitation strategy for knee OA. This hypothesis will be tested through two specific~     aims: 1) to collect and report data on the feasibility of conducting a clinical trial to~     evaluate the efficacy of using TENS+TE compared to sham TENS+TE and to TE only for treating~     patients with knee OA in a clinical setting, and 2) to determine preliminary effects of a~     4-week TENS+TE intervention compared to sham TENS+TE, and TE only on muscle strength,~     neuromuscular activation, gait biomechanics, physical function, physical activity,~     self-efficacy of physical activity, self reported quality of life, disability, and pain in~     knee OA patients. Posttests will be at 4 and 8-weeks following baseline.~   "
71207|NCT02634918|"~     Hemophilia is a bleeding disorder (deficiency of a blood clotting factor/ protein) resulting~     in bleeding in joints and muscles. As patients continue to bleed into their joints they~     develop progressive joint damage leading to joint contractures, disability and days missed~     from work and school resulting in chronic debilitating pain and compromised quality of life.~     Current therapy is the administration of the missing protein or factor concentrate on a~     scheduled basis to prevent bleeding into the joints referred to as prophylaxis. This factor~     concentrate is expensive ~ $ 3,000 - 6,000 per infusion/ week in a child weighing 20 kg~     translating into $ 77,000 /yr for life. This regimen has been shown to be effective to~     prevent joint bleeds but the timing is unclear and not based on adequate evidence. Currently~     joint damage is diagnosed using MRI which is expensive and requires sedation in children < 6~     yrs of age. Therefore there is a need for a user friendly tool such as a ultrasound to~     monitor for the development of joint disease and tailor treatment based on an individual~     child's needs. This would also enable differentiating a joint bleed from a soft tissue bleed~     which present similarly and duration of treatment tends to be longer for a joint bleed.~     Acharya et al have previously shown that ultrasound is comparable to MRI for the diagnosis of~     hemophilic joint disease in hemophilia patients over the age of 6 years. However, the~     diagnostic findings in children < 18 years with hemophilia on ultrasound is not well~     defined(1).~      The hemophilic synovium after repeated joint bleeds reveals the development of new vessels~     which are fragile and contribute to recurrent joint bleeds. Acharya et al have previously~     shown that angiogenesis, a process of new vessel formation is active in hemophilic synovium~     and angiogenic markers were significantly elevated in hemophilic patients with joint disease~     when compared to those without (2). Since ultrasound can detect these new vessel changes in~     the hemophilic synovium in hemophilia patients with joint disease and hemophilia patients~     with joint disease demonstrate elevated markers of new vessel formation these investigators~     would now like to determine whether radiological findings of hemophilic joint disease~     correlate with serological angiogenic markers. This may enable the development of biomarkers~     for hemophilic joint disease.~      Findings from this study will enable the development of ultrasound as a user friendly tool in~     the hemophilia clinic in order to understand whether every pain and swelling in a joint is~     actually a joint bleed or soft tissue bleed and to monitor for joint changes to institute or~     augment scheduled factor infusions ( prophylaxis). This will also result in significant~     improvement in quality of life with tailored prophylaxis .~   "
71208|NCT02634905|"~     -  Atopic dermatitis is a chronic relapsing disease, which is highly prevalent in children~          (15%). Therapeutic patient education (TPE) has been recognized as a key priority topic~          for future AD research. The strongest evidence in favour of TPE efficacy in AD comes~          from a large study assessing repeated multi-disciplinary group education sessions in a~          hospital setting. However, this type of intervention is both resource and time consuming~          and is not adapted to typical French practice. However, in some french dermatology~          centers, simple first level nurse-led TPE interventions are offered in addition to~          physicians consultations. Unfortunately, the content of these interventions seems to~          vary greatly depending on the caregiver and the center and the benefits of these~          practices have not yet been assessed. Therefore, nurse-led TPE is not considered as~          current care in France for AD patients.~        -  Thus, there is a need to rigorously assess the benefits of additional, well-structured,~          simple nurse-led individual TPE interventions for children with AD and their families~          compared to standard care alone. This study will be the first large, adequately powered,~          multicenter RCT trial assessing this type of intervention in children with AD.~   "
71209|NCT02634892|"~     Objective - To demonstrate the efficacy of the pressure redistributing cooling mattress~     overlay compared to usual care in mitigating the progression of early pressure ulcers in~     critically ill (ICU) patients via a prospective randomized human clinical trial.~      Specific Aim - The clinical trial will evaluate the efficacy and safety of the PRO-TECT ™~     mattress overlay in ICU patients who have already developed early pressure ulcers (Stage 1~     and 2) and preventing further progression to more severe pressure ulcers (Stage 3 and 4) as~     well as potential faster regression (i.e. healing of Stage 1 and 2 pressures).~   "
71210|NCT02634879|"~     The shift towards value-based reimbursement in U.S. healthcare is accelerating. Payment~     reform initiatives have taken many shapes—accountable care organizations, bundled payments,~     value-based purchasing, medical homes, global payment—but all share the common strategy of~     tying provider (physician, hospital, health system) reimbursement to performance on costs,~     outcomes, or both. Yet, pay-for-performance has demonstrated little effect on physician~     behavior and patient outcomes. Payers and provider groups are in need of novel approaches to~     structure provider incentives—both financial and non-financial—to better promote the delivery~     of quality, cost-effective care. In this project, the study team plans to study how~     behavioral economic principles can improve the effectiveness of physician incentives to~     deliver higher quality and lower cost care. They will test the application of specific~     behavioral economic principles including immediacy, social pressure, and loss aversion in~     incentive design and implementation. The study will contribute to an empirical foundation for~     re-design of existing physician incentive programs and implementation of new policies through~     secondary data analyses and a multi-arm experiment that evaluate the impact of promising~     behavioral economics principles on the effectiveness of provider financial and nonfinancial~     incentives.~   "
71211|NCT02634866|"~     Arterial hypertension (AH) is an important clinical social and economic problem, related to~     the increased cardiovascular risk. AH is associated with cardiovascular hemodynamic~     alterations, including left ventricular diastolic dysfunction (LVddf). In consequence of~     increased blood pressure, the effectiveness of LV as a blood pump decreases and the symptoms~     of heart failure (HF) may occur. Thus, the identification of noninvasive markers related with~     the progression from the asymptomatic AH to LVddf/HFpEF would be beneficial.~      Another issue is that the diagnostic difficulties in patients with LVddf and HFpEF stem from~     the limited possibility to assess the hemodynamic response to exercise. Thus, there is a need~     for more detailed methods of cardiovascular monitoring while exercise testing.~      We hypothesize that some new noninvasive hemodynamic parameters, characterizing left~     ventricular (LV) function and arterial stiffness, may help to predict the risk of~     cardiovascular events and future occurrence of LVddf/HFpEF. Moreover, we assume that~     cardiopulmonary exercise test (CPET), completed with new methods of noninvasive hemodynamic~     monitoring (impedance cardiography and applanation tonometry), would provide additional value~     in the assessment of the cardiovascular hemodynamic response to exercise.~      The study is intended to verify these hypothesis.~   "
71212|NCT02634853|"~     The purpose of this study is to assess the safety and efficacy of Tavilermide Ophthalmic~     Solution compared with Placebo Ophthalmic Solution in treating the signs and symptoms of dry~     eye.~   "
71213|NCT02634840|"~     Several technical modifications based on the anatomical position of the neurovascular bundle~     and its bony mandibular canal have been developed, aiming to prevent injury to the~     intraalveolar nerve We hypothesized that the incidence of neurosensory disturbance (NSD)~     should be reduced using our bilateral sagittal split osteotomy (BSSO) technique, because~     direct intra-alveolar nerve injury can be avoided. The aim of this study was to introduce our~     modified BSSO technique and evaluate the subsequent incidence of postoperative neurosensory~     disturbance of the IAN.~   "
97594|NCT02289794|"~     This Phase I multi-center placebo controlled study is conducted in healthy women with a~     history of recurrent urinary tract infections (UTI) aged between 18 and 70 years.~   "
71218|NCT02634775|"~     Children with chronic kidney disease (CKD) suffer from one of the most devastating diseases~     in childhood resulting in a lifelong need for health care, and a 3 times decreased life~     expectancy. In addition, they have important comorbidities that negatively impact on their~     quality of life and integration in society, jeopardizing their future even after a potential~     transplantation. Retention of uraemic toxins is accepted to play a major role in the~     pathogenesis of the comorbid conditions, but studies in children are lacking. Furthermore,~     there are currently no good tools to evaluate severity and monitor adequacy of treatment,~     resulting in suboptimal management.~      The overall scientific objective of this four years UToPaed IWT-TBM project is to provide the~     clinician with new diagnostic and therapeutic tools for the management of children with CKD,~     based on the improved understanding of uraemic toxicity.~      In UToPaed (part 1), the investigators will associate concentrations of a wide variety of~     uraemic toxins with different comorbidities in CKD children, i.e. growth, protein-energy~     wasting, quality of life, cardiovascular risk factors, circadian rhythm, sleep quality, and~     psychosocial and neurocognitive functioning (i.e. cross-sectional and longitudinal). Those~     toxins of which concentrations are best correlated with comorbidities during the progress of~     CKD and those having representative kinetics (UToPaed - part 2: Kinetic analysis) will be~     selected as markers. During this third part of UToPaed, these markers will be, together with~     the comorbidities, further tracked after interventions, i.e. starting on dialysis,~     transplantation, changes in dialysis strategy.~      From the validated kinetic models (UToPaed - part 2 and 3), an open access user-friendly~     prediction simulator (PAEDSIM) based on patient characteristics and marker concentrations~     will be developed to optimise and individualise the dialysis therapy.~      By providing clinicians with more advanced and appropriate tools to improve management of all~     children with CKD, i.e. better assessment of the degree of renal dysfunction, better~     determination of the ideal time to start renal replacement therapy, and more accurate~     monitoring of dialysis adequacy, the investigators aim to improve neurocognitive and~     psychosocial functioning (short term), growth, maturation into puberty, and social~     integration (median term) and survival (long term).~   "
71219|NCT02634762|"~     This prospective validation study evaluates the ability of a risk algorithm, which can~     simultaneously predict the risk of death at 7 days and 30 days for patients with acute heart~     failure presenting to the emergency department. The risk algorithms for prediction of 7-day~     (Emergency Heart failure Mortality Risk Grade [EHMRG]) and 30-day mortality (EHMRG30-ST) have~     been previously derived.~   "
71220|NCT02634749|"~     Dietary factors during infancy, e.g. high intakes of protein, fast carbohydrates and~     saturated fat increase the risk of adult obesity, type 2 diabetes and hypertension. However,~     current dietary recommendations to infants are based on traditions and experiences whereas~     research is basically lacking.~      Towards the end of the first year of life the infant will normally become increasingly~     suspicious towards fruits and vegetables. However, these foods are an important part of~     healthy eating. When and how these food items should be introduced into the diet of young~     children is unclear.~      New Nordic Diet, an initiative from the Nordic Council of Ministers calls for a larger intake~     of fruits, vegetables, whole grain, fish and game. In adults such diet improves weight and~     biomarkers of insulin resistance and cardiovascular disease. Since dietary preferences are~     founded early in life it is logical to introduce such a diet already when the child is~     starting complementary foods.~      In a randomized controlled study from 6 mo of age, we want to explore if a Nordic~     complementary diet with lower protein intake, more vegetable fats and a systematic~     introduction of fruits and greens will improve body composition, metabolic biomarkers, the~     composition of faecal microbiota (associated with obesity), cognitive development and the~     consumption of foods that can lay the foundation for better long-term diet. If the study has~     the expected results, these will have a direct impact on the dietary habits of Swedish~     children during infancy and childhood and thus their long-term health.~   "
71221|NCT02634736|"~     This cluster RCT study will investigate the effectiveness of strength/balance Exergames~     (exercise and computer games that use body movements as controls) developed to improve~     balance, function, prevent falls and increase exercise adherence for older people in the home~     setting. The proposal incorporates postural stability Exergames that have been developed with~     users based on best evidence strength and balance exercise (OTAGO and Postural Stability)~     currently used by therapists, safe for older people and can be used in the home setting~   "
71222|NCT02634723|"~     The purpose of this post-marketing safety study is to evaluate the safety, immunogenicity,~     and effectiveness of ADVATE in previously untreated patients (PUPs) in China with moderate to~     severe hemophilia A.~   "
71223|NCT02634710|"~     This is a nonrandomized Phase II pilot protocol to determine the feasibility, toxicity and~     disease control (local control, overall and progression-free survival) using hypofractionated~     preoperative radiation therapy in patients with primary localized soft tissue sarcomas (STS).~   "
71224|NCT02634697|"~     The purpose of this study is to determine if an eight week multimodal Relaxation Response~     Resiliency Program (3RP) intervention can effectively improve symptom severity, frequency and~     quality of life (Q.O.L) in atrial fibrillation (AF) patients. This will be measured by a~     reduction in AF symptom score, perceived stress, anxiety, hostility and depression.~   "
71225|NCT02634684|"~     This application seeks renewed support for MH59803, Dopaminergic substrates of startle~     gating across species, to extend a clear path of bench-to-bedside progress towards a~     critical paradigm shift in therapeutic models for schizophrenia (SZ) and schizoaffective~     disorder, depressed type (SZA): the use of Pharmacologic Augmentation of Cognitive Therapies~     (PACTs). This novel therapeutic strategy for SZ/SZA directly addresses the need for more~     effective treatments for this devastating disorder. MH59803 has investigated the neural~     regulation of laboratory-based measures of deficient information processing in SZ/SZA~     patients, using rodents and healthy human subjects (HS) to explicate the biology of these~     deficits, and to establish a rational basis for developing novel therapies for SZ/SZA. In its~     first 9 years, MH59803 studies of the neural regulation of prepulse inhibition (PPI) of~     startle in rats focused on basic neurobiological and molecular mechanisms. Over the past 2~     years of support, MH59803 studies moved from bench-to-bedside, focusing on dopamine (DA)~     agonist effects on PPI and neurocognition in HS, and their regulation by genes identified in~     cross-species studies. These studies detected biological markers that predict PPI-enhancing~     and pro-cognitive effects of the DA releaser, amphetamine (AMPH) in humans, leading to~     specific predictions of AMPH effects on PPI, neurocognition and Targeted Cognitive Training~     in SZ/SZA patients. If confirmed in the present application, these predictions could help~     transform therapeutic approaches to SZ/SZA. This renewal application of MH59803 thus reflects~     a logical progression of studies at systems and molecular levels, translated first to HS, and~     now to potentially transformative therapeutic models in SZ/SZA patients.~   "
71668|NCT02628847|"~     This is a small, pilot randomized clinical trial of administering sildenafil citrate to~     individuals within 10 days of ischemic stroke who have motor impairment and who are~     undergoing inpatient rehabilitation compared to placebo. The primary outcome is motor~     recovery at one and three months.~   "
71226|NCT02634671|"~     Background:~      The present study aims to identify the mechanisms underlying the deficit in facial emotion~     recognition reported both in schizophrenia and the 22q11.2 deletion syndrome, and thus,~     reveal a distinction between the two disorders. Indeed, despite the clinical overlap between~     the two syndromes, some of the symptoms appear to be specific to only one of them. In~     particular, the disturbance of visual functions is specifically observed in the 22q11.2DS.~     Hence, the difficulties in facial emotion recognition in schizophrenia and in the 22q11.DS~     are likely accounted by different cognitive impairments. Investigating which mechanisms are~     disturbed would allow a specialized support for patients.~      Our main hypothesis is that the deficit in facial emotion recognition is more related to~     visual impairments in the 22q11.2DS than in schizophrenia. This hypothesis will be tested in~     two groups of patients (22q11.2DS and schizophrenic patients) and a control group (healthy~     subjects) using an experimental paradigm based on electroencephalography (EEG).~      A second aim of this study is to determine whether the severity of the two disorders'~     symptoms is correlated with the cerebral response to facial expressions. To answer this~     question, a set of clinical and neuropsychological tests will be conducted for each patient.~   "
71227|NCT02634658|"~     This study plans to learn more about whether simpler diagnostic tests can be used to identify~     the development of acute neuromuscular loss of function in patients with critical illness and~     respiratory failure receiving mechanical ventilation. ICU patients admitted to the University~     of Colorado Hospital will be screened for eligibility and enrollment in the study to receive~     weekly measurements of nerve and muscle function through nerve conduction studies (NCS),~     muscle ultrasound tests, and concentric needle electromyography (EMG) tests.~   "
71228|NCT02634645|"~     A prospective outcomes study in patients with and esophageal cancer (EAC) and Barrett's~     esophagus (BE) associated neoplasia being evaluated for endoscopic eradication therapy (EET).~   "
71229|NCT02634632|"~     Legitimized by the Leonetti law of April 22, 2005, advance directives (AD) appear in various~     places of care that alongside the end of life, and even tend to be generalized to all areas~     related to health care in general. In this context, a prospective study to assess how the~     patient will seize the AD and identify the different problems writing these AD will be~     conducted. From this study, it will establish recommendations for the implementation of AD in~     the Multidisciplinary Oncology Department and Therapeutic Innovations service and in oncology~     in general. They will be asked patients if they choose to write their AD, complete and sign~     the AD pre-written in the book or not to draft their AD. The choice of the patients, but also~     the reasons they associate thereto and, where appropriate, their AD written will be~     collected. The patient will also inform its demographic and socio the case report (clinical~     data) should be completed by the investigator. During the first part of research, the use of~     AD by patients and will be assessed and analyzed in connection with the characteristics of~     these patients (history of the disease, course of care, socio-demographic) and the reasons~     they set out to explain their choice. For those who write their AD, they will, in a second~     step, subject to thematic content analysis to identify the main aspects that the subject~     convened to consider its end of life.This research therefore lead to the definition of the~     contours of a user device AD in oncology in general. This study was qualified biomedical~     research because of the sensitive nature of the study population and bring the patient to~     personal preoccupations when filling the questionnaire on the choice of directing advance~     directives and their contents.~   "
71230|NCT02634619|"~     The investigators propose a randomized non-blinded comparison of dorsal vs. ventral approach~     for buccal mucosa graft urethroplasty in the bulbar urethra. Buccal mucosa graft is a common~     method of repairing the strictured urethra. Current evidence suggests the two approaches for~     placement of the graft are equally successful at correcting the stricture and the two~     approaches have similar risks of complications. The investigators propose to randomly assign~     appropriately selected patients to either a dorsally- or ventrally-placed graft. No~     additional procedures beyond normal care protocol will be required of the patients. Success~     will be assessed via objective and subjective methods; complications will be tallied in a~     standardized fashion. Outcomes will be measured at two years.~   "
71231|NCT02634606|"~     Elevated blood cholesterol, and particularly LDL cholesterol, is a risk factor for heart~     disease. Tocotrienols are naturally-occurring compounds in foods that may have beneficial~     effects on blood cholesterol. Tocotrienols are members of the vitamin E family, and are found~     in barley, oats, rye, coconut oil and rice bran oil, but the richest source of tocotrienols~     is palm oil. Certain of these tocotrienols have been shown to be effective in lowering LDL~     (or 'bad') cholesterol, with no adverse effects on the HDL (or 'good') cholesterol. The~     purpose of this study is to determine the effects of a palm-oil derived tocotrienol~     supplement on blood cholesterol, and particularly LDL cholesterol, in individuals who are~     taking statins, and have either elevated or normal cholesterol levels. Study subjects will~     consume a palm-oil derived supplement of tocotrienol for 3 months to determine its effects on~     LDL cholesterol.~   "
71232|NCT02634593|"~     Obesity during pregnancy increases the risk for high glucose and diabetes in the mother, and~     for obesity and comorbid metabolic disease in the offspring. Results of previous intervention~     studies designed to improve the metabolic health of obese mothers, and thereby reduce the~     risk to their offspring, have been modest at best. Furthermore, few studies have proved to be~     efficacious among low income African American women who have high risk for the transmission~     of obesity to future generations. The purpose of this study is to examine the feasibility of~     changing the types of foods and drinks that are consumed at night during late pregnancy in~     order to improve maternal glucose tolerance and reduce the risk for future obesity in the~     child.~   "
71233|NCT02634580|"~     The primary hypothesis is that evolocumab (AMG 145) SC will be well tolerated and will result~     in greater reduction of LDL-C than ezetimibe.~   "
71234|NCT02634567|"~     Patients diagnosed with any type of multiple sclerosis (MS) who show objective evidence of~     attention problems will be randomized to standard medical care (treatment as usual) or~     attention training, which will be completed at their home using a commercially available~     attention training task (Cogmed Working Memory Training - CWMT) for 5 weeks. Patients will~     undergo cognitive testing before and after intervention and at 6 months follow up.~   "
74004|NCT02598219|"~     The aim of this study is to evaluate the sentinel node policy in early stage endometrial~     carcinomas at intermediate and high risk of recurrence (by comparing the sentinel node policy~     to current French initial staging protocols).~   "
71235|NCT02634541|"~     Axial spondyloarthritis is an inflammatory rheumatic disease mainly affecting joints in the~     spine and the sacroiliac joints. Inflammatory pathways are likely the central link from axial~     spondyloarthritis to the known increased risk of atherosclerotic morbidity. Positron emission~     tomography (PET) is the most sensitive method to detect inflammatory foci in clinical~     practice. A few small studies have demonstrated that PET imaging together with computed~     tomography (PET/CT) detects inflamed tissues in relevant patient groups. One study suggested~     that antirheumatic treatment diminishes the inflammation detected in PET/CT. No study so far~     has disclosed whether aortic inflammation is present in patients with spondyloarthritis, and~     whether the inflammation would wane with efficient antirheumatic treatment. The current study~     is aimed to grade the articular and aortic inflammatory signals in the PET/CT imaging before~     and after antirheumatic treatment of clinically active axial spondyloarthritis.~      Sixty patients aged 18-75 years with axial spondyloarthritis and radiologic sacroiliitis as~     detected either by MRI or X-ray will be recruited. Twenty of those are DMARD-naive, and 40~     patients have axial spondyloarthritis resistant to sulfasalazine or other conventional~     antirheumatic drug. In addition, approximately 30 patients without spondyloarthritis but with~     stable coronary heart disease and approximately 20 healthy controls will be taken as~     historical controls. All the axial spondyloarthritis patients are PET/CT scanned after~     inclusion in the study. The DMARD-naive patients (n=20) are started sulfasalazine-based~     regimen for 12 weeks, which is the time point for a second PET scan for this subgroup.~     Adalimumab will be commenced for those without remission at 12 weeks. After another 16 weeks,~     those with adalimumab will be scanned with PET/CT for the third time. The subgroup with~     active disease in spite of prior conventional treatment (n=40) is also scanned with PET/CT~     right after the enrolment and after 16-week treatment with adalimumab. The first 15 patients~     form a pilot group, which is used to check the validity of the power calculation.~      The project will give essential new information on PET-detectable inflammation in the~     patients with axial spondyloarthritis. The results will be published in international~     publication series. The publications will form the basis for a doctoral thesis. Funding for~     the project comes from Abbvie Ltd.~   "
71236|NCT02634528|"~     This study in healthy volunteers aims to demonstrate similar PK and PD properties of the new~     human isophane Insulin, Julphar Insulin N, and the already approved reference Insulin,~     Huminsulin® Basal. All participants will receive both study treatments on two separate dosing~     days.~   "
71237|NCT02634515|"~     This study in healthy volunteers aimed to demonstrate similar PK and PD properties of the new~     short-acting human soluble insulin, Julphar Insulin R, and the already approved reference~     insulin, Huminsulin® Normal. The trial participants received both study treatments on two~     separate dosing days.~   "
71238|NCT02634502|"~     This study aims to explore the efficacy and safety of radiofrequency ablation combined with~     S-1 in pancreatic cancer patients with liver metastasis, as well as the correlation of serum~     microRNA and patients' prognosis. This protocol will be overseen by the Fudan University~     Institutional Review Board which has Federal Wide Assurance through the U.S. Department of~     Health & Human Services (Approved: April 25, 2002).~   "
71239|NCT02634489|"~     A study to compare the pharmacokinetics of tamsulosin HCl and solifenacin succinate after~     co-administration of single entity tablets and of the combination tablet EC905 under steady~     state conditions at three dose strengths.~   "
71240|NCT02634476|"~     It is well-established that many substance misusers experience impairment in cognition~     (thinking skills), particularly those needed to regulate and monitor behaviour and ensure~     that goals are achieved. According to the dual-process model, addiction arises from an~     imbalance in 'bottom-up' processing i.e., overactive automatic (impulsive) processes that~     drive behaviours and impaired 'top-down' controlling processes that stop behaviours~     associated with negative consequences. As a result, the individual becomes more sensitive to~     cues in their environment (e.g., alcohol images) that trigger the addictive behaviour.~     Cognitive-bias modification (CBM) is a novel, computer-based training paradigm that trains~     the brain to pay less attention to negative/harmful cues and more attention to positive or~     neutral cues. This approach minimizes the overactive 'bottom-up' processes and improves the~     'top-down' control processes of unhealthy behaviors which enables the addicted individual to~     make better decisions. Recently, CBM has been used with addicted population to alter the~     tendency to approach alcohol, with one German study showing that a 4-session training~     programme was associated higher rates of abstinence at one-year (Wiers et al., 2011). The~     current study examines whether a novel computer based training programme alters cognitive~     biases (the tendency to approach alcohol related stimuli) in alcohol-dependent inpatients,~     and examine whether this enables them to be better at decision-making more generally, and its~     impact on craving and post-discharge abstinence rates. The study will also explore whether~     individual differences in impulsivity and sensitivity to reward and punishment determine~     response to the training programme. This will be achieved using a parallel-groups randomized~     superiority trial design involving approximately 80 patients attending inpatient withdrawal~     programmes in Victoria. The findings are likely to have implications for the design and~     delivery of psychosocial interventions delivered during early recovery from~     alcohol-dependence to optimise treatment effectiveness.~   "
71241|NCT02634463|"~     The purpose of this study is to collect whole blood and plasma venous and capillary samples~     from participants taking aripiprazole, olanzapine, paliperidone, or risperidone for the~     development of antipsychotic immunoassays.~   "
71242|NCT02634450|"~     In Mozambique, early infant HIV diagnosis (EID, i.e. HIV screening of infants under 18 months~     of age) is conducted using molecular diagnostics at central laboratories in Maputo, Nampula,~     Beira and Quelimane. However, test volumes are growing and many parts of the country do not~     have close access to laboratories. Test samples are transported over large distances and this~     can introduce testing delays, especially for patients in rural and remote areas of the~     country. There are now new POC EID technologies becoming available that will enable diagnosis~     of HIV in infants within minutes or a couple of hours on site in the clinic, operated by non~     technical staff and without laboratory infrastructure. This protocol describes a plan to~     conduct an evaluation of a Point-Of-Care (POC) Early Infant Diagnosis (EID) testing~     technologies that are being considered for use in Mozambique, and to pilot those technologies~     in order to provide more effective diagnostics and clinical care to patients. During this~     implementation pilot, sites are randomized to use either conventional or POC EID testing only~     before the inclusion of the patients in the study. No consent will be asked to the parents or~     guardians. A written permission will be asked to the Direção Provincial de Saúde of both~     provinces to implement the POC device as routine in those intervention sites. All the~     information that will be analyzed will be collected from the routine care and it will be~     analyzed as a group.~   "
71243|NCT02634437|"~     This study is designed to observe the effect of renal function on the pharmacokinetic,~     safety, and tolerability profiles of Ulipristal acetate following administration of a single~     oral dose of a 10 mg Ulipristal acetate tablet.~   "
71244|NCT02634424|"~     The purpose of this study is to evaluate the implementation of pharmacokinetic (PK) driven~     prophylaxis in current clinical practice~   "
71264|NCT02634164|"~     Diabetes is classified as an impairment of the body's ability to control blood glucose~     levels. Uncontrolled hyperglycemia can give rise to macrovascular (i.e., heart disease and~     stroke) and microvasculature damage such as retinopathy, nephropathy and neuropathy. These~     comorbidities may definitively reduce quality of life.~      Hypotheses to be tested:~        1. The ingestion of amino acids L-Isoleucine and L-Leucine at a therapeutic dose prior to a~          glucose load will concurrently and independently improve glucose tolerance.~        2. The ingestion of L-Isoleucine and L-Leucine separately or together will have a minimal~          effect on incretin responses of Glucagon-like peptide-1 and Glucose-dependent~          insulinotropic peptide (GLP-1, GIP).~   "
71245|NCT02634411|"~     Ventilator-associated pneumonia (VAP) accounts for 25% of infections in intensive care units~     (Réseau RAISIN 2012). A short duration (8 days; SD) vs. long duration (15 days; LD) of~     antibiotic therapy has a comparable clinical efficacy with less antibiotic use and less~     multidrug-resistant pathogens (MDR) emergence. These results have led the American Thoracic~     Society to recommend SD therapy for VAP, with the exception of documented VAP of~     non-fermenting Gram negative bacilli (NF-GNB), including Pseudomonas aeruginosa (PA-VAP), due~     to the absence of studies focusing specifically on PA-VAP. Thus the beneficial effect of SD~     therapy in PA-VAP is still a matter of debate. In a small (n=127) subgroup analysis, a higher~     rate of recurrence with SD therapy (n=21, 32.8%) has been observed compared with LD therapy~     group (n=12, 19.0%). Unfortunately, the definition of recurrence was essentially based on~     microbiological rather than clinical data, and the higher rate of recurrence observed could~     rather reflect a higher rate of colonization more than a new infection.~      Interestingly, a trend for a lower rate of mortality was also observed in the SD group (n=15,~     23.4%) compared with the LD group (n=19, 30.2%), but this study was clearly underpowered to~     detect a difference of mortality between groups.~      The two strategies were considered as not different, for the risk of mortality in a recent~     meta-analysis, performed on the very few available studies (n=2), that (OR = 1.33, 95% CI~     [0.33 to 5.26] for SD vs. LD strategies respectively). However, this conclusion remains~     questionable considering the large confidence interval of the risk and the power of these~     studies.~      Primary objective and assessment criterion: To assess the non-inferiority of a short duration~     of antibiotics (8 days) vs. prolonged antibiotic therapy (15 days) in P. aeruginosa~     ventilator-associated pneumonia (PA-VAP) on a composite end-point combining Day-90 mortality~     and PA-VAP recurrence rate during hospitalization in the ICU.~      Study Design :~      Randomized, open-labeled non inferiority controlled trial 32 French Intensive Care Units~     participating to the study~      Research period:~      Total study duration: 27 months Inclusion period: 24 months Duration of participation for a~     patient: 90 days~   "
71246|NCT02634398|"~     The purpose of this Post Market Observational Study is to monitor the effect of the Axium®~     SCS System in the management of chronic pain following surgical lumbar discectomy in subjects~     whom are routinely scheduled for treatment with the Axium® SCS System.~   "
71247|NCT02634385|"~     Laparoscopic partial nephrectomy (LPN) is often reserved for patients with a small peripheral~     tumour, in the hands of an experienced surgeon since it demands a high degree of endoscopic~     skill. Renal vessel clamp for vascular control is a required step during standard LPN.~     However, this creates a time limiting step for the surgeon and induces renal injury via warm~     ischemia and reperfusion injury. This novel approach can substantially reduce renal injury~     during LPN via superselective embolization of level II renal arteries pre-operatively. This~     technique facilitates the performance of a clamp-less, zero-ischemia LPN, significantly~     simplifying the procedure by remove time thresholds within which to perform tumor excision.~     The preliminary results are promising; however, there is a need for further corroboration of~     their results, in addition to a randomized controlled trial comparing this modified, zero~     ischemia technique with standard LPN.~   "
71248|NCT02634372|"~     The purpose of this study is to determine whether EMDR (vs supportive therapy) is effective~     in relapse prevention over an observational period of 2 years in bipolar patients with a~     history of traumatic events.~   "
71249|NCT02634359|"~     The study objective is to collect data to assess the accuracy and reliability of Earlysense~     fertility cycle monitoring performance vs. acceptable known reference methods such as blood~     tests and intra-vaginal Ultrasound currently used as validated methods to detect ovulation~     and pregnancy. In addition the collected data will be used to further enhance and improve the~     existing algorithms.~   "
71250|NCT02634346|"~     This study will evaluate the efficacy of ALKS 3831 in adult subjects with acute exacerbation~     of schizophrenia.~   "
71251|NCT02634333|"~     Multiple studies have implicated vascular endothelial growth factor VEGF as a major causative~     factor in human eye diseases characterized by neovascularization including proliferative~     diabetic retinopathy (PDR) and vascular permeability including diabetic macular edema (DME).~     While there is strong evidence that PDR outcomes are markedly reduced in eyes that are~     treated with monthly anti-VEGF therapy (A Study of Ranibizumab Injection in Subjects With~     Clinically Significant Macular Edema (ME) With Center Involvement Secondary to Diabetes~     Mellitus: RIDE/RISE) and moderately reduced in eyes that received fairly frequent dosing~     during the 1st year of treatment (Diabetic Retinopathy Clinical Research Network protocol I),~     it is unknown whether or not an earlier but less frequent dosing regimen would result in~     similar, favorable anatomic outcomes, and whether favorable anatomic outcomes subsequently~     would result in favorable visual acuity outcomes.~      If this study demonstrates that intravitreous aflibercept treatment is effective and safe for~     reducing the onset of PDR or center involved- DME (CI-DME) in eyes that are at high risk for~     these complications, a new strategy to prevent vision threatening complications of diabetes~     will be available for patients. The application of intravitreous aflibercept earlier in the~     course of disease (i.e., at the time when an eye has baseline severe non-proliferative~     diabetic retinopathy) could help to reduce future potential treatment burden in patients, at~     the same time resulting in similar or better long-term visual outcomes, if PDR and DME are~     prevented.~      The primary objectives of this protocol are to 1) determine the efficacy and safety of~     intravitreous aflibercept injections versus sham injections (observation) for prevention of~     PDR or CI-DME in eyes at high risk for development of these complications and 2) compare~     long-term visual outcomes in eyes that receive anti-VEGF therapy early in the course of~     disease with those that are observed initially, and treated only if high-risk PDR or CI-DME~     with vision loss develops.~      Secondary objectives include:~        -  Comparing other visual acuity outcomes between treatment groups, such as proportion of~          eyes with at least 10 or at least 15 letter loss from baseline, or gain or loss of at~          least 5 letters at the consecutive study visit just before and at the 2- or 4-year visit~        -  Comparing optical coherence tomography (OCT) outcomes, such as mean change in OCT~          central subfield thickness and volume from baseline~        -  Comparing proportion of eyes with at least 2 and 3-step worsening or improvement of~          diabetic retinopathy severity level (scale for individual eyes) by central reading~          center from baseline~        -  Comparing associated treatment and follow-up exam costs between treatment groups~        -  Comparing safety outcomes between treatment groups~   "
71252|NCT02634320|"~     This study will evaluate the safety and tolerability of aripiprazole lauroxil (also known as~     ARISTADA, ALKS 9070).~   "
71253|NCT02634307|"~     This study will evaluate the long-term safety and tolerability of ALKS 8700 for the treatment~     of Relapsing Remitting Multiple Sclerosis (RRMS)~   "
71254|NCT02634294|"~     Aim: to observe the graft versus tumor effect of Pegylated Interferonα-2b in patients with~     hematological malignancies relapsed after allogeneic hematopoietic stem cell transplantation~     (alloHSCT) Patients: patients relapsed after alloHSCT, men and women aged 14-60 years,~     without vital organ dysfunction or ongoing graft-verus-host disease (GVHD).~      Number of subjects: 50, Single center, one group, prospective. Drug: pegylated interferon~     alpha-2b (Peg Intron®; Schering-Plough) 1~1.5ug/kg qw, until occurrence of grade II or higher~     grade of acute GVHD, or no response to treatment after 8 doses of treatments.~   "
71265|NCT02634151|"~     The purpose of this study is to assess the efficacy, safety, and tolerability of multiple~     doses of gemcabene 600 mg QD compared to placebo in patients with hypercholesterolemia not~     adequately controlled on high-intensity or moderate-intensity stable statin therapy. Patients~     with HeFH, ASCVD, or otherwise uncontrolled, may be included with baseline LDL-C value ≥ 100~     mg/dL. Subjects will be randomized 1:1 to gemcabene 600 mg QD or placebo.~   "
71266|NCT02634138|"~     This study will assess the benefit of a neuromuscular electrical stimulation device in~     patients suffering from symptoms and effects of critical limb ischaemia.~   "
71907|NCT02625727|"~     Using double blind, randomized controlled design to study the immediate, short-term and~     intermediate-term therapeutic effects of ultrasound guided hyaluronic acid injection and~     hyaluronic acid combined corticosteroid injection to patients with knee osteoarthritis.~   "
71255|NCT02634281|"~     SUMMARY Rationale: Worldwide, cigarette smoking carries a high mortality. Since the available~     cessation programs are not effective for all smokers, new strategies are necessary for~     tobacco control.~      Primary objective: To investigate whether a 6-week varenicline preloading facilitates smoking~     reduction and cessation compared with the standard varenicline treatment schedule.~      Design: Parallel group, double-blind, randomised controlled clinical trial. Participants:~     Smokers of both sexes from the general population. Methods: Participants will be randomized~     into two groups of treatment. Subjects in Group A will receive varenicline for six weeks~     while those in group B will receive placebo for 5 weeks and varenicline for 1 week. During~     this phase, subjects in both groups will be asked to reduce cigarette smoking by 50 percent.~     At week 6 all participants will be instructed to stop smoking before receiving 12 weeks of~     varenicline treatment. Visits will be arranged at randomization, week 4, week 6 (Quit day~     (QD)) and at week 1, 6, 12, and 24 after QD.~      Measurements: These will include vital signs, smoking history, spirometry, expired CO,~     salivary cotinine, nicotine dependence, and withdrawal symptoms. Primary outcome is~     continuous abstinence at 6 months.~      Sample size: For an estimated difference of quit rates of 15% at 24 weeks (30% for group A~     vs. 15% for group B) 121 subjects per group are needed (Total = 242 subjects).~      Statistical analysis: T tests (rational variables) and x2 test or Fisher's exact test~     (nominal variables) will be used as appropriate.~      Expected benefits: This study might contribute to optimize the current use of varenicline.~   "
71256|NCT02634268|"~     Symptoms of chronic obstructive pulmonary disease (COPD) and high body mass index (BMI)~     overlap. The investigators are trying to find out if a program proven to help people lose a~     modest amount of weight and increase their physical activity will improve COPD symptoms for~     those with a high BMI. The program uses a series of digital video discs (DVD) sessions~     focused on healthy eating and physical activity, and encourages participants to monitor their~     weight, diet, and physical activity for two years. For those who want to, they will be able~     to work with a health coach to help meet weight and activity goals. We hope that the program~     will lead to weight loss, better exercise tolerance, and less shortness of breath. To be in~     the study, participants will need to have COPD, high BMI, history of smoking, shortness of~     breath, and be at least 40 years old.~   "
71257|NCT02634255|"~     Rocuronium, a nondepolarizing neuromuscular blocking agent, is used in general anesthesia to~     provide conditions for endotracheal intubating. Recommended dose is 0,6 mg/kg and 90 seconds~     after intravenous injection, patients can be intubated.~      Anxiety levels may vary in patients undergoing emergency and elective surgery. Patients~     undergoing emergency surgery may display exaggerated laryngoscopic responses. The purpose of~     this study is to investigate the effect of patient anxiety levels on the onset time of~     rocuronium in terms of anxiety scores and train of four (TOF) 0.1 times.~   "
71258|NCT02634242|"~     The purpose of the current study was to check the physiological improvement of SWT on liver~     and skin and also the antioxidation in healthy adults.~   "
71259|NCT02634229|"~     Monogenic diabetes accounts for 1-2% of diabetes cases, although it is often misdiagnosed as~     either type 1 diabetes or type 2 diabetes. Knowledge of the genetic etiology of diabetes~     enables more appropriate treatment, better prediction of disease progression, screening of~     family members and genetic counseling. These monogenic diabetes result from gene mutations~     that reduce beta-cell function. To date, about 20 genes involved in insulin-secretion pathway~     hav been identified; they correspond to a broad of two main clinical conditions [neonatal~     diabetes mellitus (NDM) and Maturity-Onset Diabetes of the Young (MODY)]. However, it still~     remains subtypes of monogenic diabetes that are unelucidated. The investigators project focus~     on families with a clinical and familial history highly suggesting a MODY diabetes but~     without genetic etiology. The investigators objective is to set up a collection of families~     with at least three family members presenting a MODY diabetes.~   "
71260|NCT02634216|"~     The purpose of this 12 week longitudinal study is to test the effect of the dietary~     supplement, Capros, on blood glycemic index of Type 1 diabetics that have a sensor that~     provides continuous glucose monitoring (CGM). 20 Type 1 Diabetics will take the Capros~     supplement for 12 weeks to determine the effect of blood glycemic index. Capros, is a~     generally safe dietary supplement currently sold over the counter in the United States. Type~     1 diabetes also known as juvenile diabetes is commonly diagnosed in children and young~     adults. Insulin is converted into energy needed for daily living, and with diabetes, insulin~     is not produced in the body as it should causing many problems. In traditional Indian~     medicine, the gooseberry Phyllanthus emblica has been used for thousands of years as an~     effective source of polyphenols and antioxidants. A 12 week longitudinal study to determine~     the effect of the dietary supplement, Capros, on the blood glycemic index in patients with~     Type 1 diabetes (T1D).~   "
71261|NCT02634203|"~     Chronic thromboembolic pulmonary hypertension (CTEPH) is a severe form of pulmonary~     hypertension characterized by obstruction of the pulmonary vasculature by residual organized~     thrombi, leading to increased pulmonary vascular resistance (PVR), progressive pulmonary~     hypertension, and right failure.~      In patients deemed operable, pulmonary endarterectomy (PEA) is the gold standard treatment~     and is the only potentially curative treatment. However, some patients are ineligible for~     surgery owing to occlusion of distal vessels. The best treatment option for these~     non-operable CTEPH patients is not yet established.~   "
71262|NCT02634190|"~     To assess and compare the performance of the HR HPV HC2® test (Qiagen/Digene) and the APTIMA®~     HPV Assay (Hologic) using LBC Specimens (ThinPrep® Pap Test) for the detection of HPV~     infection and high-grade CIN lesions in a screening population of women 30 years of age or~     older in Germany.~   "
71263|NCT02634177|"~     In this randomized clinical trial, subjects will be assigned to either an assay-guided~     treatment condition (AGT) or a treatment-as-usual condition (TAU). All subjects will provide~     a DNA sample at the Screening Visit for the Genecept Assay ™. In the AGT condition, assay~     results will be provided to the treating investigator, who will use the results to guide~     antidepressant pharmacotherapy. In the TAU condition, the investigator will treat the~     subjects without the knowledge of the pharmacogenetic testing results. Assay results for all~     subjects will be provided to the investigator once all Week 8 visit procedures have been~     completed. Raters of the primary endpoint assessment and subjects will remain blinded to~     treatment assignment.~   "
71303|NCT02633644|"~     The purpose of the ENDO-HF study is to determine the safety & performance of the Harmony~     System for the treatment of heart failure~   "
71267|NCT02634112|"~     Primary Endpoint:~      The main objective of this National Registry is to identify the incidence and to analyse the~     risk factors for anastomotic leakage in rectal cancer surgery From the operational point of~     view, the aim of this Registry is to systematize the collection of information on the~     different surgical services. This Registry claims to have National audit functions, allowing~     thus the knowledge of the procedures performed at each center that could enable the~     establishment of the best standard of care.~      Secondary Endpoints:~      To determine the real incidence of anastomotic leakage according to the different locations~     and techniques: uniform definition of anastomotic leakage.~      To analyze the preoperative risk factors of anastomotic leakage: PATIENT FACTOR.~      To analyse the variability in the practice of rectal anastomosis: SURGEON FACTOR.~      To analyse the influence of different stapling devices in rectal anastomosis: INSTRUMENTAL~     FACTOR To know the current treatment of anastomotic leakage and the associated morbidity and~     mortality.~      To create and validate an anastomotic leakage predictive Score.~   "
71268|NCT02634099|"~     Investigators compare the accuracy of the SpHb and hemocue with blood Hb levels~   "
71269|NCT02634086|"~     The study is to determine the long-term outcome of patients with coronary triple vessels~     disease (TVD) in the real world of China, by three different treatment strategies:~     percutaneous coronary intervention (PCI), Coronary artery bypass graft (CABG) or optimal~     medication therapy (OMT).~   "
71270|NCT02634073|"~     Lamivudine (3TC) is a nucleoside analogue indicated in combination with other antiretroviral~     agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults~     and children. Documented literature elucidates that simultaneous administration of multiple~     sorbitol-containing products could increase the potential for a significant interaction and~     may contribute to the lower 3TC exposures.~      In this study several sorbitol doses (3.2 gram (g), 10.2 g, and 13.4 g solutions) will be~     administered with lamivudine to investigate dose dependency and mimic the situation where~     multiple sorbitol-containing antiretroviral medications may be co-administered with~     lamivudine. It will be open label, randomized, 4-way crossover (by William's design method)~     design at a single centre. Randomized participants will receive a single dose of each of four~     treatments after wash out period of minimum 7 days.~   "
71271|NCT02634060|"~     Recently a smartphone application IBDoc® was developed to enable patients to measure faecal~     calprotectin at home in an easy way. In this HELP-AID trial we want to evaluate the value of~     these home based IBDoc® faecal calprotectin measurements in predicting short- and mid-term~     outcome to ADA induction therapy in patients with moderate-to-severe IBD.~      Patients known with moderate-to-severe CD and ulcerative colitis starting ADA therapy will be~     asked to participate in this study. They will be asked to collect a stool sample at 3~     different time points (week 0, 4 and 8). This faecal sample needs to be loaded on a test~     cassette with an extraction device. In a second step, the patient can turn his smartphone~     into an easy to use test cassette reader by taking a picture and using the CalApp® which is~     based on an immunochromatographic test. Finally, the CalApp® will transmit the test results~     securely to the health care professional.~      In this study we want to evaluate the predictive value of absolute and relative faecal~     calprotectin values measured by IBDoc® on clinical, biological and endoscopic outcome at week~     12. Furthermore, we want to evaluate the correlation between IBDoc® and classical ELISA~     measurements of faecal calprotectin, and the convenience of this system to the patient and~     the health care professional.~   "
71272|NCT02634047|"~     The primary aim of this study is to investigate the difference in the first attempt and~     overall success rate of different techniques for insertion of transesophageal~     echocardiography. Secondary aim is to investigate the difference of the duration of insertion~     using the selected technique, complications during insertion such as oropharyngeal mucosal~     injury and hematoma.~   "
71273|NCT02634034|"~     The purpose of this study is to compare the pharmacokinetics and safety of a controlled~     release (CR) version of pitavastatin (also referred to as NK-104) to immediate release (IR)~     pitavastatin in healthy adult volunteers.~   "
71274|NCT02634021|"~     Loading dose of dexmedetomidine is related hemodynamic instability such as bradycardia and~     hypertension.~   "
71275|NCT02634008|"~     An open label, multicentre, international pilot study of paritaprevir/ritonavir, ombitasvir,~     dasabuvir with or without ribavirin or glecaprevir/pibrentasvir for people with recently~     acquired hepatitis C virus infection with or without HIV co-infection.~   "
71276|NCT02633995|"~     The use of spinal anesthesia in pre-eclamptic pregnant woman is of considerable benefit, as~     these patients present particular hazards with general anaesthesia, such as concerns for~     rapid airway control and cerebral blood flow alterations during induction of general~     anaesthesia and intubation However, the incidence of hypotension is high during spinal~     anesthesia for Cesarean section and it may approach values up to 95 %.~   "
71277|NCT02633982|"~     In atrial fibrillation patients,anticoagulant therapy with warfarin has an excellent stroke~     preventive. Meantime,Warfarin may also increase the risk of hemorrhagic events. Considering~     this,warfarin is a drug which puts a great burden on patients and medical providers.~      With the population aging, the number of non-valvular atrial fibrillation patients is~     increasing, and a necessity that not only specialist but also general practitioners.~     Anticoagulant therapy with warfarin is not easy for general practitioners and is not commonly~     used among general practioners. In such circumstances, Rivaroxaban,a new oral direct factor~     Xa inhibitor,has become available. Rivaroxaban is administrated once a day and exert an anti-~     coagulant effect soon after administration. It hardly reacts with foods or other drugs and~     therefore does not require regular monitoring. GENERAL study is to investigate the~     effectiveness of stroke and systemic embolism in non-valvular atrial fibrillation patients~     when it is prescribed by general practioners in real life settings.~   "
71278|NCT02633969|"~     The purposes of this study are to evaluate the safety and tolerability and to model the~     single-dose pharmacokinetic profile of indomethacin capsules low dose and high dose in~     children ages 6 to <17 years experiencing mild to moderate acute postoperative pain.~   "
71279|NCT02633956|"~     This Phase 2, double-blind, randomized, placebo-controlled, multicenter study, with an~     open-label LTSE, will evaluate the effect of Obeticholic Acid, and the subsequent addition of~     statin therapy, on lipoprotein metabolism in subjects with NASH with fibrosis stage 1 to 4,~     but no evidence of hepatic decompensation.~   "
71280|NCT02633943|"~     This is a multi-center, long-term safety and efficacy follow-up study for subjects with~     hemoglobinopathies (β-thalassemia or severe sickle cell disease) who have been treated with~     ex vivo gene therapy drug product in bluebird bio-sponsored clinical studies. After~     completing the parent clinical study (approximately 2 years), eligible subjects will be~     followed for an additional 13 years for a total of 15 years post-drug product infusion. No~     investigational drug product will be administered in the study.~   "
71281|NCT02633930|"~     This study aims at evaluating efficacy and safety of berberine-containing quadruple~     therapy(berberine, lansoprazole, bismuth and amoxicillin) versus clarithromycin-containing~     quadruple therapy (clarithromycin,lansoprazole, bismuth and amoxicillin) in H. pylori~     eradication. It is hypothesized that berberine-containing quadruple therapy is non-inferior~     to clarithromycin-containing quadruple therapy. Patients with confirmed H. pylori positive~     status will be randomized to one of the treatments described above. At week 2 and 6 follow-up~     visits, a urea breath test(UBT) will be performed to confirm eradication.~   "
71282|NCT02633917|"~     The purpose of the present study was to evaluate and compare the effects of motor control~     exercises and standard exercises in the pain, incapacity and medicine intake of subjects with~     unspecific low-back pain.~   "
71283|NCT02633904|"~     Although older children and high dislocations may be more likely to require a femoral~     shortening osteotomy, the ultimate decision about whether or not to shorten a given femur~     should depend on the ease of femoral head reduction in that specific patient. Adding a~     femoral shortening procedure increases operating time and blood loss, adds a second incision,~     and necessitates future hardware removal. In addition, an unnecessary femoral shortening~     osteotomy could overly decrease the soft tissue tension around the joint, putting the hip at~     risk for redislocation. This study was designed to explore an algorithm based on strict age~     and radiographic criteria that identify those without the need of femoral osteotomy.~   "
71284|NCT02633891|"~     Obesity and the metabolic syndrome (MetS) are rapidly growing problems. Individuals with the~     MetS are at risk for not only future chronic diseases, but they have a higher prevalence of~     neuropathy, including cardiac autonomic neuropathy, and have a higher incidence of falls.~     Currently there are no effective therapies to prevent or reverse the neuropathy seen in the~     MetS or to reduced the fall risk in this population. This research project will determine if~     a tailored balance exercise program will have functional benefits and result in a reduced~     fall risk in the growing population of patients with the MetS and neuropathy.~   "
71285|NCT02633878|"~     Threatened miscarriage is manifested by vaginal bleeding, with or without abdominal pain,~     while the cervix is closed and the fetus is viable and inside the uterine cavity.Threatened~     miscarriage is a common complication of pregnancy occurring in 20% of all clinically~     recognized pregnancies and about half of these will eventually result in pregnancy~     loss.Micronized progesterone which is used in a range of indications including infertility~     due to luteal insufﬁciency and threatened and habitual abortion, has a similar molecular~     structure and pharmacological effects to endogenous progesterone.Chinese Herbal Medicines is~     a part of Traditional Chinese Medicines and has been widely used for the treatment of~     miscarriage in China and other Asian countries for centuries.CHM have become very popular~     alternative to Western medicines and are commonly used as an alternative treatment for~     threatened miscarriage.Amongst all the causes for threatened miscarriage, Kidney Deficiency~     is the most important cause leading to threatened miscarriage and Shou Tai Pill is the most~     frequently used formula (72.0%) to treat threatened miscarriage.This basic formula is made up~     of four individual Chinese medicines, including Chinese Dodder Seed (Semen Cuscuta), Chinese~     Taxillus Twig (Flerlia Taxillus), Himalayan Teasel Root (Radix Dipsaci), and Donkey-hide Glue~     (Colla Corii Asini).Furthermore, supplementary of Common/Wingde Yan Rhizoma in the formula~     can enhance the therapeutic effects by further strengthening kidney of pregnant women.The~     goal of this double-bind, randomized and double dummy controlled trial is to determine which~     of the two oral medications, CHM or Micronized progesterone, and will mostly likely result in~     live birth in women with threatened miscarriage.~   "
71286|NCT02633865|"~     Age-related cataracts remain the leading cause of treatable blindness in China. The~     prevalence of cataract blindness continues to climb due to the expanding elderly~     subpopulation. Surgery is the only available treatment; however, the cataract surgical rate~     (CSR) in China remains relatively low relative to affluent countries or certain developing~     areas. Studies have reported that the primary barrier to cataract surgery is financial~     difficulty, and this challenge could be efficiently addressed by reducing the surgical fee or~     providing free cataract surgery. However, the prices, availability and affordability of~     medicines or medical services to the poor in China require further improvement. Although a~     host of free cataract screening and surgery programs have been widely implemented in rural~     areas of China, free cataract surgery programs have rarely been implemented in~     financially-challenged urban China. Even in Guangzhou, one of the largest metropolises in~     China, many low-income cataract patients, a neglected cohort, continue to need cataract~     surgery. A program titled care for your eyes, lighten your life, jointly sponsored by the~     People's Government of Guangzhou Municipality, the Bureau of Civil Affairs of Guangzhou~     Municipality, and the Zhongshan Ophthalmic Center (ZOC), has been initiated in Guangzhou to~     implement a program of free clinics in parks and free cataract surgery targeting the~     impoverished population living in urban China in 2012. After 3 years' exploration, the~     management mode of this program has been perfected, and approximately 4000 cataract surgeries~     had been performed on the low-income elderly.~      Although there are a large number of poor communities throughout the country, free cataract~     surgery programs in poor urban China are restricted to several metropolises due to limited~     medical resources and social overlook. Fully understanding patient satisfaction regarding the~     free cataract surgery program and understanding the patient characteristics of this special,~     neglected community may contribute to the improvement and the further expansion of the~     management mode of free cataract surgery programs.~   "
71287|NCT02633852|"~     A 12-month, Multicenter Study to Evaluate the Efficacy of Treat and Extend Regimen (TER) of~     Aflibercept (EYLEA) 2mg /0.05 ml as a Second Line Treatment for Diabetic Macular Edema - TADI~     Study~   "
71288|NCT02633839|"~     This is an open label, parallel group study to evaluate the pharmacokinetics (PK) and safety~     of a single dose of CVT-301 in smoking and non-smoking adults.~   "
71289|NCT02633826|"~     This investigator-initiated study will analyse the role of pre-formed alloreactive T cells on~     acute rejection episodes and graft outcome in kidney transplant recipients after living~     donation.~   "
71290|NCT02633813|"~     The current study was randomized, double blind, placebo-controlled, prospective, multicenter,~     comparative therapeutic equivalence study.~      The study duration for each patient was 6 weeks: Following were the visit details.~      V1-Baseline and Randomization Visit (Day 1). V2- End of therapy visit (at the end of week 2 +~     2 days). V3- Follow up visit (at the end of week 4 + 2 days). V4 - Test of cure visit ( at~     the end of week 6 + 4 days).~   "
71908|NCT02625714|"~     A randomized, open-label, oral multiple dosing, two-part, two-way crossover clinical trial to~     evaluate the safety/tolerability and pharmacokinetic profiles of SID142 in healthy volunteers~   "
71291|NCT02633800|"~     This study will test an investigational study drug called patritumab. It is a 'randomized~     study' which means participants have an equal chance of being assigned to receive the~     experimental medication (patritumab) or a substance that looks like the experimental product,~     but is not (placebo). Patritumab may work when combined with other medications that are~     approved for the treatment of head and neck cancer. They are called cetuximab, cisplatin or~     carboplatin. All participants will receive the other medications approved for treatment of~     head and neck cancer, even if they do not receive the experimental product.~   "
71292|NCT02633787|"~     The aim of this study is to provide information on the persistence of bactericidal antibodies~     following Menactra booster vaccination in study MTA77 ( NCT01442675).~      Objective:~        -  To evaluate the persistence of antibody responses (determined by a serum bactericidal~          assay using human complement (SBA-HC)) approximately 4 years after the administration of~          a booster dose of Menactra vaccine in trial MTA77~   "
71293|NCT02633774|"~     Atrial fibrillation (AF) is associated with impaired cognitive function (CogF) and/or~     dementia, but it is unclear whether rhythm control of AF improves CogF or brain perfusion.~     The hypothesis is rhythm control of AF improves CogF by increasing brain perfusion with~     hemodynamic amelioration compared to AF state. We will randomize the patients with persistent~     AF to rhythm control group and rate control group, and check baseline and 3rd month cognitive~     function (K-MOCA score) and brain perfusion CT. K-MOCA score and brain perfusion CT findings~     will be compared between rhythm control group and rate control group of persistent AF.~   "
71294|NCT02633761|"~     The primary aim of this trial is to compare the efficacy of mifepristone-misoprostol versus~     misoprostol alone for treatment of intrauterine fetal demise between 14 and 28 weeks LMP.~   "
71295|NCT02633748|"~     Mindfulness has been shown to help stress, fatigue, sleep complaints, and other symptoms but~     has not been extensively studied in cancer survivors. This study will enroll cancer survivors~     at the Greenville Health System Cancer Institute Center for Integrative Oncology and~     Survivorship to undergo the Mindfulness Based Cancer Survivorship (MBCS) four-week program,~     with assessments before, immediately after, and three months after the intervention. Results~     of the study will be used to develop new care models that improve cancer survivor stress and~     symptoms using mindfulness.~   "
71296|NCT02633735|"~     Although appendicitis is the most common surgical emergency in children, its diagnosis~     remains a challenge and thus, emergency department (ED) providers increasingly rely on~     computed tomography to distinguish appendicitis from other conditions. This project (a) uses~     electronic health record (EHR) technology to deliver patient-specific clinical decision~     support to ED providers at the point of care, (b) assesses the impact of this intervention on~     the use of diagnostic imaging and clinical outcomes, and (c) assesses the impact of the~     intervention on the costs of care delivered. This innovative project will be a template for~     extending EHR-based clinical decision support to other domains of emergency care to~     ultimately improve a broad range of pediatric acute care outcomes.~      The proposed intervention, referred to as appy-CDS, is specifically designed for widespread~     use in EDs and could reduce reliance on advanced diagnostic imaging for pediatric and~     adolescent patients with acute abdominal pain while maintaining or improving clinical~     outcomes. Investigators aim to develop and implement an interactive, evidence-based clinical~     decision support tool to optimize care for children and adolescents presenting to a general~     or non-pediatric ED with acute abdominal pain.~   "
71297|NCT02633722|"~     Obesity is a serious medical condition, the adverse consequences of which include increased~     risk of cardiovascular disease, diabetes mellitus, reduced fertility and cancer. The economic~     cost of obesity was placed at $58 billion dollars in Australia in 2008. Studies in mice and~     non-human primates have shown that moderate caloric restriction (CR) increases lifespan and~     reduces the incidence of cardiovascular disease, cancer, and type 2 diabetes. Reduced risk of~     chronic diseases is also observed in humans following CR. However, daily CR is difficult to~     maintain long term, since the body defends against weight loss by inducing metabolic~     adaptation and altering the hormonal appetite response. An emerging number of studies are~     examining the effects of limiting food intake to prescribed time periods per day, or every~     other day. Intermittent, or time restricted feeding describes a dieting approach where food~     is available ad libitum, however only for a limited period of time (i.e. 3-12 hours). This~     study will examine the effects of fasting for 15h/day and eating for 9-h per day on glycemic~     control and metabolic health. This study will build on the existing knowledge base in humans~     as to whether meal timing, rather than caloric restriction per se, is important to provide~     the stimulus required to improve metabolic health and reduce risk of chronic disease.~     Moreover, it will examine whether restricting feeding to later in the day is of lesser~     benefit to health.~   "
71298|NCT02633709|"~     The objective of this study is to assess the safety and tolerability of RO7034067 (RG7916) in~     healthy people. The study will assess what the body does to RO7034067 (RG7916) and what~     RO7034067 (RG7916) does to the body. RO7034067 (RG7916) will be given by mouth in gradually~     increasing doses. The data from this study will help to define the dose to further explore~     RO7034067 (RG7916) in patients with Spinal Muscular Atrophy.~   "
71299|NCT02633696|"~     This clinical trial phase I in healthy volunteers is intended to describe the oral~     bioavailability of the silybin-phosphatidylcholine complex by calculating the area under the~     curve (AUC0-? and AUC0-12) after administration of the same dose of oral silybin (AUCo) and~     intravenous silybin (AUC iv).~   "
71300|NCT02633683|"~     The objectives of the trial are to evaluate the long-term efficacy and safety of HORIZANT~     (Gabapentin Enacarbil) 600 mg daily, for the treatment of RLS in adolescents (13 to 17 years~     of age) diagnosed with moderate-to-severe primary RLS.~   "
71301|NCT02633670|"~     Kidney transplantation remains one of the most common organ transplanted today but the~     surgical technique has changed very little from the original pelvic operation. The deceased~     donor renal transplant poses a particular challenge to the surgeon due to lack of detailed~     pre operative vascular assessment. The hemopatch is a promising new sealing synthetic~     hemostatIc agent with a novel dual mechanism of action that is more convenient to apply~     rather then using other hemostatic agents, which require warming and/or mixing.~   "
71302|NCT02633657|"~     The primary objective is to assess the pharmacokinetics (PK) of gabapentin following the~     single-dose administration of HORIZANT (Gabapentin Enacarbil) in adolescents (13 to 17 years~     of age) diagnosed with moderate-to-severe Primary Restless Legs Syndrome (RLS).~   "
71304|NCT02633631|"~     The Contraceptive Choice Center will use an innovative-model of contraceptive care which was~     developed as a part of the Contraceptive CHOICE Project (CHOICE). This delivery model will~     deliver high-quality family planning services for women and reduce unintended pregnancies and~     births. This intervention will result in improved health for women, improved health care, and~     reduced costs to Medicaid.~      The Center will provide care to women ages 14-45 years of age.~   "
71305|NCT02633618|"~     A randomized, open-label , positive drug controlled (Neurotropin,Japan organs Pharmaceutical~     Co., Ltd. ), multi-center study to evaluate Analgecine's efficacy and safety for the~     treatment of neuropathic pain.~   "
71306|NCT02633605|"~     First Sense Medical®, LLC is a medical device company developing a novel breast cancer~     screening tester called the First Sense Breast Exam® Tester. This radiation free tester is~     being developed to produce data which will be analyzed by Therma-Scan Reference Laboratory.~     When the tester is in production, a test will take approximately 7 minutes and will be~     performed in a doctor's office.~   "
71307|NCT02633592|"~     To assess whether HR-ARM (High resolution Anorectal Manometry) performed in the more~     naturalistic / physiological upright, seated position on a commode provides a more valid~     assessment of anorectal function and simulated defecation than the same test performed in the~     standard, left lateral position~   "
71308|NCT02633579|"~     In this study, the investigators will evaluate if the food intake associated with the~     infusion of erythromycin is caused by the phase 3 contractions or by another yet unknown~     effect of erythromycin. To obtain this the investigators will use atropine, a muscarinic~     receptor antagonist, to inhibit the formation of contractions induced by a low dose of~     erythromycin~   "
71309|NCT02633566|"~     The purpose of this study is to investigate the efficay of functional plantar orthoses on~     flatfoot in children.~   "
71310|NCT02633553|"~     This study is designed to investigate whether adjuvant radiotherapy after complete resection~     has a better survival for stage II or III thymoma.~   "
71311|NCT02633540|"~     The aim of this study is to define a new treatment technique for T1a larynx cancer that~     maintains excellent local control with less extensive radiation fields. It is thought that~     this will lead to patients having fewer changes to their voice and a higher quality of life~     after treatment when compared to the current standard treatment.~   "
71312|NCT02633527|"~     This is a randomized, double-blind, placebo-controlled, multicenter, 5-arm, parallel-group,~     fixed dose study to assess the efficacy and safety of SPN-812 ER in treatment of children~     aged 6-12 years with ADHD. The primary objective is to assess the effect of SPN-812 ER in~     reducing ADHD symptoms. This will be measured using the ADHD-RS-IV rating scale.~   "
71313|NCT02633514|"~     This study is designed to investigate whether adjuvant radiochemotherapy after incomplete~     resection has a better survival than adjuvant radiotherapy for thymoma or thymic carcinoma.~   "
71314|NCT02633501|"~     The purpose of this study is to determine an effective and safe clinical dose of a new~     gadolinium-based contrast agent (GBCA) P03277 injection for Central Nervous System (CNS)~     lesion detection and visualization by conventional steady-state CNS imaging. Therefore,~     Contrast to Noise Ratio (CNR), a well-known quantitative parameter directly related to~     contrast medium/GBCA efficacy, has been chosen as the primary endpoint in order to have a~     precise determination of P03277 clinical dose.~      This is a multi-center, international, prospective, double-blind, randomized, controlled,~     parallel dose groups, cross-over with comparator study in male and female subjects presenting~     with either known or highly suspected focal areas of disruption of the Blood Brain Barrier~     (BBB) (e.g. primary and secondary tumors, focal inflammatory or demyelination disorders), who~     are scheduled to undergo a routine contrast-enhanced Magnetic Resonance Imaging (MRI) of the~     CNS.~      This study will be conducted in approximately 40 centers worldwide.~      Two subsets of subjects will be included in the study:~        -  The first subset will include the first subject of each study center. Subjects will be~          administered at 0.05 or 0.1 mmol/kg body weight (BW) of P03277 and MultiHance®, 0.1~          mmol/kg BW.~        -  The second subset will comprise all other subjects selected by the sites. Subjects will~          be administered at 0.025, 0.05, 0.1, 0.2 mmol/kg BW of P03277 and 0.1 mmol/kg BW of~          MultiHance®.~      During the course of the study, two MRIs will be obtained from each subject: one unenhanced~     and P03277-enhanced MRI; and one unenhanced and MultiHance®-enhanced MRI. MRI evaluations~     will be performed by on-site investigators and three independent off-site blinded readers.~   "
71315|NCT02633488|"~     The purpose of this study is to look at how insulin (a hormone that helps the cells get~     energy from sugar) in our body affects blood vessels (elasticity in the bigger blood vessels~     and blood flow in the smaller blood vessels in the arm) and how Metformin (a drug that makes~     you more sensitive to insulin) affects insulin's action on the blood vessels.~   "
71316|NCT02633475|"~     This study aimed to assess the correlation between the interleukin-10 (IL-10)-1082A/G~     polymorphism and idiopathic recurrent miscarriage (IRM) of Chinese Han. A total of 100 women~     with IRM and 100 control women with a successful pregnancy will be included in this study.~     Then genotyping will be performed.~   "
71317|NCT02633462|"~     The Purpose of this study is to assess the correlation between the inflammatory periodontal~     status and the medical treatment status in Polycystic Ovary Syndrome(PCOS) women with~     systemic inflammation and to evaluate the effect of non-surgical periodontal therapy in the~     form of scaling and root planing along with medical treatment on the level of serological~     marker of inflammation (High sensitivity-C Reactive Protein) and insulin resistance in PCOS~     women with chronic periodontitis.~   "
71318|NCT02633449|"~     The study will investigate whether cognitive behavioral psychotherapy (CBT) combined with~     prefrontal transcranial direct current stimulation (tDCS) is more efficacious with regard to~     symptom reduction in depressed patients than CBT combined with sham-tDCS or CBT alone.~   "
71319|NCT02633436|"~     To explore the significance of Solute Carrier Family 1 Member 5 (SLC1A5) in the occurrence of~     esophageal cancer, by comparing the expression of SLC1A5 between esophageal cancer tissues~     and adjacent tissues.~   "
71533|NCT02630602|"~     The purpose this study was to evaluate the therapeutic effect of a functional goat cheese on~     obese and overweight people with altered lipid profile. The functional goat cheese containing~     polyunsaturated fatty acid, in amounts exceeding other cheese, was developed to benefit~     cardiovascular health of people who need to normalize lipid profile; which in the long term~     can contribute to the prevention of cardiovascular diseases.~   "
71320|NCT02633423|"~     During general anesthesia a reduction of Functional Residual Capacity (FRC) was observed. The~     reduction of FRC could imply that respiratory system closing capacity (CC) exceeds the FRC~     and leads to a phenomenon called expiratory flow limitation (EFL). Positive End-Expiratory~     Pressure (PEEP) test is a validated method to evaluate the presence of EFL during anesthesia.~     Aim of the study will be to asses if mechanical ventilation during CardioPulmonary Bypass~     (CPB) in cardiac surgery could reduce the incidence of EFL in the post-CPB period. Primary~     end-point will be the incidence of EFL, assessed by a PEEP test, performed at different~     time-points in operating room. Co-primary end-point will be shunt fraction, determined before~     and after surgery.~      This will be a single center single-blind parallel group randomized controlled trial.~     Patients will be randomly assigned to four parallel arms with an allocation ratio 1:1:1:1, to~     receive one of four mechanical ventilation strategies during CPB.~        1. Ventilation with a Positive End-Expiratory Pressure (PEEP) of 5 cmH2O before and after~          CPB; Continuous Positive Airway Pressure (CPAP) during CPB;~        2. Ventilation without PEEP before and after CPB; CPAP during CPB;~        3. Ventilation with a PEEP of 5 cmH2O before and after CPB; No use of mechanical~          ventilation during CPB~        4. Ventilation without PEEP before and after CPB; No use of mechanical ventilation during~          CPB~   "
71321|NCT02633410|"~     The anteromedial (AM) portal technique was introduced to position the femoral tunnel in~     anterior cruciate ligament (ACL) reconstruction to more closely replicate the original~     footprint compared to the transtibial (TT) approach.1-5 Few randomized trials have evaluated~     differences in these techniques with respect to clinical outcomes. The purpose of this study~     was to determine if there are any differences in clinical outcome between the AM and TT~     approaches.~   "
71322|NCT02633397|"~     The proposed study is a Phase 2 multi-center, randomized, double-blind, placebo-controlled,~     parallel groups study aimed to evaluate the safety, tolerability and the efficacy of~     riociguat compared with placebo in patients with sickle cell disease (SCD).~   "
71323|NCT02633384|"~     Parenteral nutrition associated cholestasis (PNAC) is a common complication of prolonged and~     exclusive parenteral nutrition (PN). Infants subjected to major surgery are often unable to~     receive enteral nutrition for a long period of time, during which they require exclusive PN.~     In preterm infants, hepatic immaturity is a predisposing factor. Intravenous lipid emulsions~     (ILE) used in PN may promote PNAC or protect against it depending on their composition.~     Medium chain triglycerides (MCT) may have a hepatic protective effect. Long chain~     triglycerides (LCT) of n-3 family may protect from PNAC. In several new-generation emulsions,~     the α-tocopherol content is higher than the gamma-tocopherol content, acting as an~     antioxidant, preventing lipid peroxidation.~      The incidence and severity of PNAC in term and near-term infants subjected to corrective~     surgery for congenital abnormalities and needing prolonged PN using the ILE SMOFlipid® or~     Lipofundin® is compared. The investigators hypothesise that SMOFlipid® is more protective~     from PNAC than Lipofundin®.~      Single-center, randomized, controlled and double-blinded trial on consecutive neonates~     admitted in the NICU, with gestational age of 34 weeks or over, undergoing corrective surgery~     of congenital anomaly of the digestive tract or indirectly affecting the digestive tract.~     Recruitment if PN with ILE was started within the first 48 hours after birth. Minimum~     intervention: exclusive PN for at least 1 week.~      Main outcome: incidence of cholestasis (conjugated serum bilirubin >1 mg/dl [34 mmol/L]).~     Severity of cholestasis evaluated by the magnitude of the serum conjugated bilirubin and~     serum γ-glutamyltranspeptidase (GGT). Mixed effects regression models are used to take into~     account the correlation structure between measures in time. Crude and adjusted odds-ratios~     with corresponding 95% confidence intervals are calculated.~   "
71324|NCT02633371|"~     This is a single-center, prospective, open-label, outpatient pilot study evaluating the~     efficacy and tolerability of oxybutynin gel for axillary hyperhidrosis.~   "
71325|NCT02633358|"~     Acute myocardial infarction complicated with cardiogenic shock trigger IL-6, the strong~     inflammatory response, result in multiple organ failure, even death.~      While therapeutic hypothermia,to expect the possibility of anti-inflammatory effect via IL-6~     bi-phasic effect and IL-10 , to improve the multiple organ failure, to increase survival rate~     and well cerebral performance.~   "
71326|NCT02633345|"~     The aim of the study is to investigate the effect of tablets containing probiotic candidate~     strains, on gingival inflammation and the levels of selected pro- and anti-inflammatory~     cytokines in gingival crevicular fluid (GCF). A secondary aim is to describe the effect of~     the tablets on the salivary microbiome. The null hypothesis is that the clinical~     measurements, levels of cytokines and microbial composition of saliva will not differ from~     baseline or between the study and control group.~      The study is planned as a double-blind; placebo controlled randomized trial with two parallel~     arms. The intervention period is planned to be 4 weeks.~      80 participants are planned to be enrolled after informed consent and then randomly allocated~     to either the probiotic group or the placebo group.~      The participants are randomly assigned to one of the study groups and given supply of either~     probiotic tablets or placebo tablets.~      The probiotic tablets contain Lactobacillus rhamnosus PB01 and Lactobacillus curvatus P2-2 at~     a dose of 1 * 109 CFU(Colony Forming Units)/tablet. The participants will take two tablets a~     day for four weeks. Follow up registrations are conducted after two weeks, four weeks and six~     weeks.~      At each visit, saliva and GCF will be collected and then plaque index (PI)) and bleeding on~     probing (BOP) will be registered.~      All data will be processed with SPSS software (v 22.0; Chicago, Ill, USA). The follow-up~     values are compared to baseline within each group by Wilcoxon paired two-sided test and~     differences between groups are analyzed by Wilcoxon unpaired test. A p-value < 0.05 is~     considered statistical significant.~      The participants are fully covered by the patient insurance of The School of Dentistry which~     cover any damage to the trial participant during the study .There is no expected side effects~     to the treatment with probiotics. Probiotics are generally considered safe (GRAS: Generally~     Recognized As Safe) by The European Food Safety Authority (EFSA).~      The participants will not benefit directly from the treatment, but the knowledge gained from~     the study might contribute to the prevention of microbial derived illnesses in the mouth,~     e.g. caries and periodontitis, in the future. The sample collection does not cause any~     discomfort to the participants and the tablets have no known side effects. Therefore, the~     personal benefit of the participants corresponds to the minimal risk and discomfort to the~     participants.~   "
71327|NCT02633319|"~     The Malezi ne Kilimo Bora (Good Parenting and Farming in Kiswahili) Skilful Parenting and~     Agribusiness Child Abuse Prevention Study is a collaboration between the University of~     Oxford, University of Glasgow, and the Tanzania National Medical Research Institute (NIMR).~     It is pilot cluster randomised controlled trial (cRCT) of a community-based intervention~     implemented by Investing in Children and Our Societies (ICS), an international~     non-governmental organization (NGO) with extensive experience operating in rural Tanzania.~     The overall focus of the project is to evaluate ICS's agribusiness and skilful parenting~     programmes' impact on the prevention of child maltreatment and improvement of child and~     family psychosocial and economic wellbeing (n = 8 villages, n = 16 farmer groups, n = 240~     families).~   "
71328|NCT02633306|"~     Complex oro-facial pain is a poorly diagnosed and poorly treated cause of significant~     suffering and disability. This study will explore the ability of fMRI to identify patients~     with complex oro-facial pain who respond to transcranial magnetic stimulation therapy.~      Specific Aims:~        1. To establish baseline patterns of MRI in patients with chronic oro-facial pain without a~          definitive etiologic diagnosis.~        2. To estimate the rate of treatment success of transcranial stimulation of the primary~          motor cortex (M1) in these patients.~        3. To identify post-treatment MRI patterns that are associated with treatment success.~   "
71329|NCT02633293|"~     This is a multicenter, open-label trial to evaluate the safety and efficacy of inhaled~     treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with~     interstitial lung disease (ILD) including combined pulmonary fibrosis and emphysema (CPFE).~     The study will include about 266 patients who completed all required assessments in the~     RIN-PH-201 study at approximately 100 clinical trial centers. The study will continue Your~     participation in this study is voluntary and will last until you discontinue from the study~     or the study ends. The study will continue until each subject reaches the Week 108 visit or~     until inhaled treprostinil become commercially available for patients with PH associated with~     ILD including CPFE (whichever is sooner).~   "
71330|NCT02633280|"~     COPD is an inflammatory disease characterized by enhanced chronic airway and lung~     inflammatory responses to noxious agents (e.g. smoke, pollutants) and progressive airflow~     limitation. In COPD patients there is a spillover of peripheral lung inflammation into~     systemic circulation resulting in increased level of various inflammatory markers such as:~     IL-1β, IL-6, IL-8, and TNF-α.~      Diagnosis, now, is based on clinical evaluation and spirometry test and COPD treatment~     includes the use of LABA, LAMA and corticosteroids.~      To data no plasmatic marker able to identify the stage of COPD and the response to the~     treatment have been documented . The aim of this study is to evaluate in COPD patients the~     role of microRNA as predictive biomarker, of the disease in order to have a signature of miRs~     typically of COPD~   "
71331|NCT02633267|"~     Social anxiety disorder is a highly prevalent condition that interferes with employment.~     Prior research indicates that social anxiety disorder interferes with work attainment. This~     project involves a two-site randomized trial of a community-based cognitive-behavioral~     intervention to reduce social anxiety and improve employment outcomes among unemployed~     persons with social anxiety disorder.~   "
71332|NCT02633254|"~     So-called type 1 and 2 uterine fibroids are well treatable with Magnetic Resonance guided~     High Intensity Focused Ultrasound (MR-HIFU). The other type, type 3 fibroids, however, are~     known for their high perfusion and poor treatment outcome after MR-HIFU. This study proposes~     a new strategy to treat type 3 fibroids with MR-HIFU. Very precise, small, high-power~     sonications (heating points) will be used to occlude (part of) the feeding vessels of the~     fibroid. This deminishes the negative effect of the high perfusion and is hypothesized to~     transform a type 3 fibroid into a type 2 or possibly even a type 1 fibroid. Consequently, the~     bulk volume of the fibroid can be treated using the standard approach.~   "
71333|NCT02633241|"~     This is a pilot study to determine if a standard bolus dose and infusion of dexmedetomidine~     can significantly decrease the dose of propofol (infusion) required for accomplishing an MRI.~   "
71334|NCT02633228|"~     The objective of this study is to assess the visual outcome after the combined binocular~     implantation of +2.0 D and +3.0 D refractive multifocal intraocular lenses.~   "
71335|NCT02633215|"~     This study will evaluate the effectiveness of sustained peripheral nerve stimulation coupled~     with functional motor training, to improve hand motor function in poorly recovered stroke~     patients. The central hypothesis is that stroke patients with severe motor deficit receiving~     hand nerve stimulation and intensive task-oriented therapy will have improved motor function~     compared to patients receiving sham nerve stimulation and task-oriented therapy.~   "
71336|NCT02633202|"~     Currently, concurrent chemoradiotherapy with/without sequential chemotherapy is the standard~     treatment modality for intermediate risk NPC (stage II and T3N0M0) according to the National~     Comprehensive Cancer Network guideline. However these recommendations were based on the~     evidence in the two-dimensional conventional radiotherapy (2DCRT) era. The introduction of~     intensity-modulated radiotherapy (IMRT) in NPC treatment has brought substantial better~     treatment outcomes than 2DCRT. It has been questioned whether additional concurrent~     chemotherapy is still necessary for intermediate risk NPC within the excellent framework of~     IMRT. Thus, the investigators jointly conduct the first non-inferior randomized trial to~     determine the value of concurrent chemotherapy with cisplatin for intermediate risk NPC~     patients treated with IMRT. Given the results of clinical studies mentioned above,the~     investigators decide to adopt the concurrent regimen to be cisplatin 100 mg/m2 on day 1, 22,~     43~   "
71337|NCT02633189|"~     The purpose of this study is to test whether the combination of bevacizumab and erlotinib can~     prolong progression free survival as compared with erlotinib alone as first-line treatment in~     patients with non small cell lung cancer (NSCLC) with activating mutation of EGFR.~   "
71338|NCT02633176|"~     This is a Phase Ⅲ randomized, controlled, multi-center, trial comparing cisplatin plus~     docetaxel to cetuximab, cisplatin, and docetaxel induction chemotherapy followed by~     concurrent chemoradiation in previously untreated patients metastatic nasopharyngeal~     carcinoma (mNPC) to determine whether the addition of cetuximab to induction chemotherapy and~     chemoradiation could improve therapeutic efficacy in mNPC, and investigate predictive and~     prognostic factors for mNPC.~   "
71339|NCT02633163|"~     The purpose of this study is to evaluate the efficacy and safety of mesenchymal stem cells~     (MSCs) obtained from umbilical cords for the treatment of adults with systemic lupus~     erythematosus (SLE). The goal of this study is to determine if patients receiving an MSC~     infusion plus standard of care respond better than patients receiving placebo infusion plus~     standard of care.~   "
71340|NCT02633150|"~     Obesity, chronic disease, is a real public health problem because of its high prevalence but~     also because of the high risk of complications, including insulin resistance (IR) and type 2~     diabetes (T2D). The mechanisms involved in the development of IR are not well known.~     Oxidative stress and inflammation induced by food overload could be the initiators IR~     mechanisms in skeletal muscle, responsible for the use of nearly 80% glucose in response to~     insulin and therefore plays a major role in the regulation of glucose metabolism. Thus, an~     increase in ROS (Reactive Oxygen Species), markers of oxidative stress and chronic low-grade~     inflammation have been demonstrated in subjects with obesity, the latter decreasing in weight~     loss. Therapeutically, loosing weight is still very difficult these days, because of the~     complexity of this chronic disease. Thus, it is well established that restrictive diets to~     expose weight rebound, dramatic medically as in human terms for these patients. Support for~     physical activity is also difficult because of reduced mobility in patients, refer to the~     lack of motivation among some. Finally, investigators have no treatment against-obesity who~     have demonstrated a benefit / risk enough to be used routinely. It is therefore essential to~     seek other means of struggle against the IR, see help in weight loss.~      In parallel, it is well established that the consumption of certain antioxidants, including~     polyphenols (PP) grape as extracts and whole foods, modulates favorably several pathways~     responsible for the development of IR in cell models animals. The results of antioxidants~     supplementation in humans are few and controversial. However, most supplementation studies in~     human used a PP, Resveratrol at supra nutritional doses (ie not compatible with a balanced~     diet of fruits and vegetables). In a previous study, investigators tested the interest of a~     supplementation with red grape PP nutritional doses in healthy subjects with metabolic risk~     (overweight subjects and related to the first degree of T2DM patients) on IR hyperinsulinemic~     euglycemic clamp measured. During this study, the PP have prevented the central mechanisms of~     muscle IR that are oxidative stress and mitochondrial dysfunction induced by a load fructose.~      For this project, investigators propose to test the effect of a red grape PP supplementation~     at nutritional doses for 8 weeks on IR and weight loss in 30 obese insulin resistant. This is~     a double-blind randomized placebo-controlled. This supplementation will be associated with a~     standard support for their obesity performed routinely in the Nutrition and Diabetes unit.~      Specific inclusion criteria: Female or male nondiabetic 50-65 years, BMI> 30 kg / m2 and with~     a HOMA> 3.~      The main objective is to test whether supplementation PP improves systemic insulin~     sensitivity (GIR: rate glucose infusion) measured by hyperinsulinemic-euglycemic clamp (gold~     standard for measuring insulin sensitivity) in insulin-resistant obese subjects.~      Secondary objectives are to:~        -  Test whether supplementation PP improves insulin sensitivity to tissue (fat and muscle)~          and compare the response to supplementation in these two tissues.~        -  Determining the cellular and molecular mechanisms involved in improving IR: regulation~          of inflammation, oxidative stress.~        -  Determine whether supplementation PP optimizes weight reduction compared to a standard~          single support.~      NSN: The number of subjects required was evaluated from our previous work (2013 Hokayem et~     al.) Whose main objective was to assess the impact of PD versus placebo in first degree~     relatives of patients with diabetes type 2. Under a bilateral alternative hypothesis of a~     nonparametric test (Mann-Whitney), 1: 1 ratio, a power of 80% and an alpha risk of 0.05, the~     number of subjects was estimated at 15 per group.~      Methodology: Anthropometric measurements, assessment of body composition (DEXA) system~     application characterization (metabolism, inflammation, oxidative stress, adipokines and~     insulin sensitivity: clamp hyperinsulinemic-euglycemic, lipopolysaccharides: LPS) / tissue~     characterization (biopsies of skeletal muscle and tissue adipose): insulin sensitivity,~     inflammation, oxidative stress, gene regulation (sirt1), mitochondrial activity / cell~     characterization (adipocyte precursor and muscle) insulin sensitivity, inflammation,~     oxidative stress, sirt1.~      Investigators hope to demonstrate that a non-pharmacological treatment based on nutritional~     doses of PP supplementation can improve insulin sensitivity in insulin-resistant obese~     patients, refer to optimize weight loss compared to a standardized management of obesity and~     determine the mechanisms involved.~   "
71341|NCT02633137|"~     The purpose of this study is to find out what effects, good and/or bad, the treatment~     including 1) Lenalidomide-RCHOP, 2) R-HIDAC, and 3) Lenalidomide-Rituximab maintenance has on~     the participant and their lymphoma.~   "
71342|NCT02633124|"~     This study evaluates the potential interest of a new multi-lumen infusion access device~     (Edelvaiss® Multiline NEO) in the prevention of catheter-related bacteremia when~     administering injectable drugs in premature infants. This device will be compared to the~     standard infusion set of each center.~   "
71343|NCT02633111|"~     The purpose of this study is to determine whether a blood test can accurately detect whether~     if the participant's lymphoma has come back after completion of initial chemotherapy~     treatment for their aggressive B-cell Non-Hodgkin lymphoma. The purpose of the study is to~     see if MRD in blood samples can potentially replace CT scans after completion of chemotherapy~     in the future.~   "
71575|NCT02630056|"~     The purpose of this study is to validate the dosimetric parameters that correlate with acute~     hematologic toxicity (HT) in patients with rectal cancer treated with neoadjuvant~     chemoradiotherapy.~   "
71344|NCT02633098|"~     This study evaluates the safety and effectiveness of pre-operative artesunate given orally~     once a day for 14 days prior to surgery in patients with Stage II/III colorectal cancer.~      Artesunate is an established antimalarial drug with an excellent safety profile, is well~     tolerated and affordable. A number of laboratory studies and one small pilot clinical study~     in patients with colorectal cancer have shown that artesunate can reduce the proliferation~     and growth of cancer cells.~      Two hundred patients diagnosed with Stage II/III operable colorectal cancer will be randomly~     allocated to receive oral artesunate 200mg daily or a matching placebo for 14 days prior to~     surgery. Patients will be followed up closely for 5 years to see if giving artesunate~     preoperatively reduces the risk of cancer recurring after surgery.~   "
71345|NCT02633085|"~     The purpose of this study is to determine if there is a patient satisfaction preference of~     Fixed Bearing versus Mobile Bearing Unicompartmental Knee Arthroplasty (UKA) in patients who~     are at a minimum two years post operative. Patient reported outcomes and expectations will be~     analyzed along with all retrospective chart data in patient with a Fixed Bearing or a Mobile~     Bearing UKA in one or both knees.~   "
71346|NCT02633072|"~     The objective of this study is to assess the visual outcome after the combined binocular~     implantation of +2.75 D and +3.25 D full-diffractive multifocal intraocular lenses.~   "
71347|NCT02633059|"~     This phase I/II trial studies the side effects and best dose of idasanutlin and ixazomib~     citrate when given together with dexamethasone in treating patients with multiple myeloma~     that has returned after a period of improvement. Drugs used in chemotherapy, such as~     idasanutlin and dexamethasone, work in different ways to stop the growth of cancer cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Ixazomib citrate may stop the growth of cancer cells by blocking some of the~     enzymes needed for cell growth. Giving idasanutlin, ixazomib citrate, and dexamethasone~     together may work better in treating patients with multiple myeloma.~   "
71348|NCT02633046|"~     Multicenter, multiple dose study to examine the effect of H.P. Acthar® Gel (repository~     corticotropin injection) in adult subjects with idiopathic focal segmental glomerulosclerosis~     (FSGS) who have failed to achieve remission with, or who are intolerant of, 1 or more~     previous immunosuppressive therapies.~   "
71349|NCT02633033|"~     This observational study aims to characterize the patient population and describe multiple~     sclerosis exacerbation recovery, treatment patterns and safety outcomes in patients with~     multiple sclerosis experiencing exacerbations treated with H.P. Acthar® Gel (Acthar Gel) in~     standard practice in the United States.~   "
71350|NCT02633020|"~     Protocol CELIM-RCD-002 is designed to be a Phase 2a randomized, double-blind,~     placebo-controlled, parallel group study to evaluate the efficacy and safety of AMG 714 for~     the treatment of adult patients with Type II Refractory Celiac Disease (RCD-II), an in situ~     small bowel T cell lymphoma.~   "
71351|NCT02633007|"~     This study is a double-blind, randomized, placebo-controlled, 2-period, crossover study to~     evaluate safety and PK of 3 doses of CVT 301 levodopa (l-dopa) in adults with asthma.~   "
71352|NCT02632994|"~     This study is for patients who have participated in a previous study and who continue to~     receive benefit to have continued access to study drug and/or treatment.~   "
71353|NCT02632981|"~     Interleukin-32 (IL-32) is a recently described cytokine that is a strong inducer of~     pro-inflammatory cytokines such as tumor necrosis factor (TNF)-α. A previous report have~     reported that Porphyromonas gingivalis-derived LPS significantly up-regulated IL-32~     expression compared with the unstimulated cells in monocytes (THP-1 cells). They suggested~     that IL-32 may contribute to the pathogenesis of periodontal disease. In the present study~     the investigators hypothesized that IL-32 levels may increase in the gingival crevicular~     fluid (GCF) and saliva of patients with chronic periodontitis compared with healthy controls~     and these levels may decrease together with treatment.~   "
71354|NCT02632968|"~     Pinhole surgical technique is a novel minimally invasive, predictable, efficient, time and~     cost-effective technique for treatment of multiple gingival recession. This procedure~     involves no releasing incision, suturing or sharp dissections. It has been shown that the~     greater post-operative displacement of gingival margin may cause greater root coverage. Based~     on this hypothesis, a split mouth randomized controlled clinical trial was planned to compare~     the clinical outcome of pinhole surgical technique with and without the use of orthodontic~     buttons and sutures in the treatment of multiple gingival recessions.~   "
71355|NCT02632955|"~     Hemodialysis (HD) remains the most prevalent form of renal replacement therapy (RRT) for~     patients with End Stage Renal Disease (ESRD). Loss and dysfunction of vascular access is a~     significant contributor to morbidity in ESRD patients on HD. The National Kidney Foundation's~     Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines suggest that all ESRD patients~     should initiate dialysis with a functioning permanent vascular access with arteriovenous~     fistulas (AVF) preferred over arteriovenous grafts (AVG). Central venous catheters (CVC) are~     the least preferred vascular access for HD due to the complications associated with them.~     Despite these recommendations, up to 80% patients start dialysis with a CVC. One of the~     reasons for low AVF rates is early fistula failure (EFF). The most important causes for EFF~     amenable to intervention is stenosis anywhere in the circuit. Endovascular approach has shown~     a high rate of technical success in the treatment of stenotic lesions related to HD~     arteriovenous access. Percutaneous balloon angioplasty (PBA) is considered the treatment of~     choice for these lesions. Despite good technical and immediate success PBA has poor long term~     outcomes with recurrence rates of 60-70% at 6 months. One of the reasons could be the damage~     caused by angioplasty itself leading to intima-media rupture promoting the cascade of events~     leading to further development of neo intimal hyperplasia (NIH). Recently the use of covered~     stents at the time of angioplasty has shown better patency rates at 6 months but still not~     optimal. Lately the development of drug eluting stents and drug eluting balloons (DEB) have~     shown considerable advantage in clinical trials related to coronary and peripheral arterial~     disease angioplasty. In a randomized control trial, the researchers are planning to assess~     the efficacy of DEB angioplasty as compared to standard PBA in AVF's with EFF.~   "
71375|NCT02632695|"~     The goal of this study is to test FOOTFIT and enhanced FOOTFIT+, home-based mobile health~     (mHealth) physical activity (PA) interventions for a minimally ambulatory, chronically-ill,~     population with leg ulcers. A highly sensitive clinically designed Bluetooth® enabled~     accelerometer and tracking device (BEAT) worn on the foot during a progressive and~     evidence-based non-exertive leg conditioning activities for lower leg function (CALF)~     captures minute foot movements and sends the data to a Smartphone. This six-week feasibility~     study will compare FOOTFIT to FOOTFIT+, with the added connectivity feature, to promote~     patient-provider communication, evaluate adherence to PA, and assess signals of efficacy on~     functional outcomes in a very low fitness population.~   "
71376|NCT02632682|"~     Real-time Diagnosis of Barrett's Esophagus: Comparing Confocal Laser Endomicroscopy with~     Conventional Histology for the Identification of Specialized Intestinal Metaplasia~   "
71356|NCT02632942|"~     Hemodialysis (HD) vascular access dysfunction is a huge clinical problem which results in~     significant morbidity amongst patients with End Stage Renal Disease (ESRD), causing a severe~     economic burden on any health care system. Native arteriovenous fistula (AVF) is the~     preferred form of permanent dialysis access since it is associated with the best long term~     outcome as compared to other forms of dialysis access. Despite the clinical benefits, many~     patients on HD do not have AVF as there dialysis access. One of the reasons for low AVF rates~     is early fistula failure (EFF). The two most important causes for EFF amenable to~     intervention are stenosis anywhere in the circuit and/or presence of accessory vein (av).~     Although management of stenosis is well established with relatively clear guidelines, the~     management of av lacks clear scientific approach. In a recent study researchers recommended a~     hemodialysis arteriovenous flow quantification-diameter (HAQ) criteria for accessory vein~     obliteration. The purpose of this controlled, blinded, prospective trial is to assess the~     clinical utility of the HAQ criteria as compared to current recommendations for av~     obliteration.~   "
71357|NCT02632929|"~     The purpose of this study is to see whether the use of AMNIOEXCEL® improves healing and~     reduces the need to cut off all or part of a leg (amputation) in high-risk patients who have~     diabetes and foot sores (also sometimes called ulcers or wounds).~   "
71358|NCT02632916|"~     The aim of this study is to acquire preliminary, pilot data over a 2-year period on the~     safety and efficacy of subcutaneous denosumab versus the current CHEO standard-of-care~     (intravenous zoledronic acid) for the treatment of osteoporosis in children. Both denosumab~     (1.0mg/kg) and zoledronic acid (0.025mg/kg) will be given as four doses separated by a six~     month interval (i.e. at baseline, 6 months, 12 months and 18 months), with follow-up to 2~     years.~   "
71359|NCT02632903|"~     This study explores the effect of zoledronic acid on incident vertebral fractures and~     osteonecrotic lesions in children recently diagnosed with acute lymphoblastic leukemia.~   "
71360|NCT02632890|"~     The purpose of the study is to determine a) if the implementation of abatacept (Orencia®)~     patient alert card (PAC) resulted in effective understanding of key safety messages and b) if~     the degree of understanding of key safety messages is associated with improved clinical and~     safety outcomes.~   "
71361|NCT02632877|"~     Diabetic foot ulcers (DFU) develop because of the interaction of predisposing factors like~     neuropathy, angiopathy and infection. Likewise, environmental factors like lesion hygiene,~     diet and life style.~      DFU results as a complication in diabetic patients and it is the most common cause of~     non-traumatic foot amputation in people older than 50 years. Foot amputation decreases~     patients´ quality of life since only 33% of them will continue walking with the use of a~     prothesis.~      However, 30% of patients subjected to amputation will die in the first year after surgery and~     by the 5th year, post-surgery 50% of them will need the amputation of the remaining body~     extremity.~      According to the World Foundation for Diabetes, in Latin America there are 18 million people~     with Diabetes Mellitus Type 2 (DM2). This number will increase in the next 20 years to 30~     million.~      Medical expenses for diabetic patients are calculated to be around 8,000 million dollars,~     annually. In Mexico, according to the Mexican Federation for Diabetes there are 6.5-10~     millions of diabetic patients.~      Amputation due to DFU complications has many social and economic implications. In Mexico in~     2011 diabetes mellitus complications were the principal cause of death in the institute of~     mexican social security (IMSS) population.~      On the other hand, 5-methyl-1-phenyl-2-(1h)-pyridone (PFD) is considered an anti-inflammatory~     drug that promotes re-epithelization due to fibroblast stimulation, angiogenesis and~     vasculogenesis during tissue remodeling.~      According to this, the investigators believe that PFD could play an important role in DFU~     resolution and for this reason, the investigators consider necessary to analyze the efficacy~     of 5-methyl-1-phenyl-2-(1h)-pyridone for the treatment of DFU since it has showed improvement~     in chronic skin ulcers in pilot studies.~      Nowadays, DFU treatment includes management of metabolism, angiopathy and neuropathy along~     with broad-spectrum antibiotic therapy. However, several reports indicate it is insufficient~     for and adequate control of diabetic patients.~      Then, it is important to develop efficient therapies for the treatment of DFU. In this~     context, Ketanserin (Sufrexal™) is a drug to induce scar formation. It has been demonstrated~     to decrease peripheral vascular resistance, platelet aggregation and improves hemorheologic~     parameters.~      Topical administration of ketanserin has showed beneficial effects in inflammation,~     granulation and epithelization.~      Since these two drugs have showed beneficial effects in tissue regeneration, the~     investigators believe it is important to compare their safety and efficacy for the treatment~     of DFU~   "
71362|NCT02632864|"~     The standard treatment of unresectable hepatocellular carcinoma (HCC) is transarterial~     chemoembolization (TACE) or sorafenib. Though the TACE and the agent showed survival benefit~     in several randomized phase III trials, the benefit was modest.~      Recently, radiotherapy (RT), especially conformal and higher dose with the advancement of RT~     techniques, showed favorable response rate with acceptable local control rate. Based on those~     promising results, RT was actively applied in HCC who are not indicated with surgery and/or~     radiofrequency ablation.~      Many researchers reported that there is a relationship between RT dose and tumor response~     rate. RT dose, however, is frequently limited because the complications (like radiation~     induced liver disease (RILD), radiation induced gastro-duodenal toxicity, etc.) are also~     closely related with higher exposed RT dose.~      Proton beam has characteristic depth-dose distribution contrast to photon, the Bragg peak.~     The advantage of this dose distribution could be more highlighted in HCC management, because~     of the weakness and maintenance importance of liver function itself in HCC patients. In fact,~     the superior results of proton beam therapy in HCC were constantly reported in several groups~     as prospectively as well as retrospectively.~      In this background, the investigators planned the present study to evaluate the efficacy and~     safety of proton beam therapy in HCC patients who are not indicated with surgery and/or~     radiofrequency ablation (RFA).~   "
71363|NCT02632851|"~     This observational, non-interventional multicentric study compares the inhalation therapy on~     patients suffering on respiratory tract infections and/or acute bronchitis between Ectoin~     inhalation solution and Pari NaCl (0.9%) inhalation solution~   "
71374|NCT02632708|"~     The purpose of this Phase I, multicenter, clinical trial is to evaluate the safety of AG-120~     and AG-221 when given in combination with standard AML induction and consolidation therapy.~     The study plans to evaluate 1 dose level of AG-120 in subjects with an IDH1 mutation and 1~     dose level (and 2 dose schedules) of AG-221 in subjects with an IDH2 mutation. AG-120 or~     AG-221 will be administered with 2 types of AML induction therapies (cytarabine with either~     daunorubicin or idarubicin) and 2 types of AML consolidation therapies (mitoxantrone with~     etoposide [ME] or cytarabine). After consolidation therapy, subjects may continue on to~     maintenance therapy and receive daily treatment of AG-120 or AG-221 until the end of study or~     until relapse, development of an unacceptable toxicity, or hematopoietic stem cell transplant~     (HSCT). End of study is defined as 2 years from the time the last subject enrolls, or sooner,~     if all subjects have come off study (or withdrew consent) prior to 2 years after the last~     subject has enrolled.~   "
71415|NCT02632162|"~     Sleep disordered breathing (SDB) is common in cardiovascular patients. Patients after cardiac~     surgery will be screened for SDB with the ApnoeLink device at the beginning of cardiac~     Rehabilitation and then after 3 weeks and 3 months.~   "
71364|NCT02632838|"~     Monitoring and self-management are important components of effective chronic disease care and~     improved patient outcomes. With the rapid development of integration of mobile health~     technology (mHealth) into health care delivery services, mHealth intervention provides a~     great opportunity to improve the efficiency of chronic disease management. However, little is~     known about whether mHealth interventions can effectively impact the health and health care~     outcomes in underserved populations. This pilot study will assess the preliminary~     effectiveness of a mobile-based health intervention in an urban underserved community with a~     high incidence of hypertension. It is hypothesized that patients with hypertension will~     experience improved outcomes due to the use of a mHealth application compared with patients~     who are not using the application. The findings from this study will advance our~     understanding of the utility of mHealth interventions among underserved populations and~     generate evidence to support this new health care delivery approach in underserved urban~     communities.~      In this study, three hypotheses will be tested:~        1. Hypertension patients using the mHealth application exhibit a greater decrease in blood~          pressure and better maintenance over a 6-month period compared to those who receive~          standard care.~        2. Hypertension patients using the mHealth application will exhibit more effective~          self-management as compared to those who receive standard care.~        3. Utilizing the mHealth application helps nurses to monitor hypertension status more~          effectively than monitoring hypertension status without the mHealth application.~   "
71365|NCT02632825|"~     Nasal High Flow (NHF) and CPAP are established forms of respiratory support in neonates and~     often produce similar clinical outcomes. It has been shown in adults that NHF produce~     different effects on ventilation during wakefulness and sleep. There is no physiological data~     on effects of NHF in neonates. The physiological effects may be impacted by sleep/awake~     status.~   "
71366|NCT02632812|"~     This is a double-blind, placebo-controlled, randomized, parallel trial to evaluate if~     rebamipide reduces the number of gastric events caused by naproxen. Sample size is 24~     participants (12 per treatment group), male or female, aged 18 years-old and above.~      Primary objective is to compare rebamipide effervescent granules 100 mg twice daily, plus~     naproxen (coated tablets) 550 mg twice daily to placebo plus naproxen 550 mg twice daily, for~     seven days, in reduction of gastric events caused by naproxen. Secondary objective is to~     evaluate safety and tolerability of rebamipide after multiple administrations.~      Participants will receive either rebamipide + naproxen or placebo + naproxen, as above,~     during 7 consecutive days, which will be accompanied by a follow-up visit.~      Gastric integrity will be assessed, before and after treatment, by endoscopy, with stomach~     biopsies and detection of H. pylori. Additionally, detection of occult blood in the stool~     will be performed, before and after treatment.~      From the above-mentioned biopsies, dosage of prostaglandin E2 and histopathological analysis~     will be performed.~   "
71367|NCT02632799|"~     Nasal High Flow (NHF) and CPAP are established forms of respiratory support in neonates and~     often produce similar clinical outcomes. The aim of the study was to investigate airway~     pressure during NHF and CPAP in neonates.~   "
71368|NCT02632786|"~     This is a global, multicenter, Phase 2b, randomized, double-blind, placebo-controlled,~     two-arm, parallel-group efficacy and safety study of NEOD001 as a single agent administered~     intravenously in adults with AL amyloidosis who had a hematologic response to previous~     treatment for their amyloidosis (e.g., chemotherapy, autologous stem cell transplant [ASCT])~     and have persistent cardiac dysfunction.~   "
71369|NCT02632773|"~     Improving social communication outcomes for children with autism spectrum disorders (ASD) has~     important public health implications. The proposed research is a randomized controlled trial~     of 108 children with ASD that examines how specific parent characteristics influence outcomes~     of two different parent-mediated language interventions. Evaluating effective language~     intervention strategies for children with ASD supports NIDCD's mission of behavioral research~     aimed to remediate the disordered process of language development in children with ASD.~   "
71370|NCT02632760|"~     This randomised double-blind, controlled phase IV trial will compare the efficacy, safety and~     cost-effectiveness of preoperative IV iron with placebo in patients with anaemia before~     elective cardiac surgery.~   "
71371|NCT02632747|"~     This is a randomized, double-blind, double-dummy, placebo-controlled, cross over design trial~     with empagliflozin compared to placebo that is added to open-label ramipril in patients with~     type 1 diabetes.~   "
71372|NCT02632734|"~     Normally, dentists do not graft the socket after extraction of teeth. When they do graft they~     use particulate graft devices. The purpose of this study is to examine whether coral~     particles of 300-450um in comparison to coral cones of 4-5mm wide and 8-10 mm long will~     preserve alveolar ridge of maxilla or mandible when grafted immediately after tooth~     extraction. The coral grafting devices are processed from Porites corals grown in aquariums,~     under controlled environment. The devices are cleansed and sterilized by gamma irradiation.~     The measurements during follow ups will be performed from CT x rays and measurements by~     caliber and models.The width and height measurements from follow up x rays and models. The~     study will be performed on 10 patients, that two parallel teeth are diagnosed to be~     extracted, in same patient.The data will be analysed for bone loss and compared to previous~     published studies. Also comparison between two devices will be performed.~   "
71373|NCT02632721|"~     Phase I Dose Escalation: Primary objective is to determine the MTD and the recommended dose~     for Phase I Extension. Secondary objective is to investigate the safety, pharmacokinetics and~     efficacy of BI 836858 in combination with decitabine Phase I Extension: Primary objective is~     to collect additional data on safety, pharmacokinetics and efficacy and to define the~     Recommended Phase II Dose (RP2D) of BI 836858 in combination with decitabine.~      Phase II: Primary objective is to investigate efficacy, safety and pharmacokinetics of BI~     836858 in combination with decitabine compared to decitabine monotherapy.~   "
71416|NCT02632149|"~     The purpose of this study is to evaluate the clinical effectiveness of PINS vagus nerve~     stimulatior in children with Lennox-Gastaut Syndrome.~   "
71417|NCT02632136|"~     A newly developed technique of TAP block solely performed by surgeons will be used for~     postoperative pain relief following laparoscopic total extra peritoneal (TEP) Inguinal hernia~     repair. Our alternative hypothesis is that laparoscopic-assisted TAP block is better than the~     periportal wound infiltration in controlling the postoperative pain.~   "
71377|NCT02632669|"~     This clinical study will evaluate side effects, quality of life and cancer control in~     patients with prostate cancer diagnosed on only one side of the prostate gland.~      The diagnosis of unilateral prostate cancer will be made by means of a prostate transperineal~     template biopsy (TTB) and multiparametric magnetic resonance imaging (mpMRI).~      Patients will be treated with low dose rate brachytherapy, using permanent iodine seed~     implants.Treatment will be limited to the side of the gland where the cancer has been~     diagnosed and is therefore called focal brachytherapy.~      Prostate brachytherapy is usually applied to the whole prostate gland. After whole gland~     prostate brachytherapy urinary, bowel and sexual function may be affected. In this focal~     approach, the side effects will be evaluated by means of patient questionnaires.These will be~     repeated at various intervals after treatment.The results will be compared to the same~     questionnaires responded by patients who have undergone whole gland brachytherapy.Therefore~     an assessment can be made whether focal therapy produces fewer side effects than whole gland~     brachytherapy.The observation period will last for two years after treatment. A biopsy and~     mpMRI will be repeated after two years to evaluate prostate cancer control.~   "
71378|NCT02632656|"~     The primary objective is to measure the association between extracellular RNA (ex-RNA) levels~     in plasma in patients receiving aggressive outpatient therapy for CHF with (1) cardiac~     remodeling and (2) cardiovascular events. The investigators will follow patients during~     standard medical therapy for CHF to assess changes in ex-RNA levels in the plasma, and how~     these are associated with cardiac remodeling (by cardiac imaging) and outcomes.~   "
71379|NCT02632643|"~     The study aims to demonstrate the efficacy of the sensorimotor approach developed by A. Piron~     (taught to the patient in three sessions) regarding three parameters related to TMD: facial~     pain, functional incapacities and hypertonia.~      The subjects in the study are 18 to 77 years old and present the following conditions: a TMD~     disorder caused or aggravated by hypertonia and responsible for cervico-maxillo-facial pain~     and/or a functional incapacity in the last 30 days.~   "
71380|NCT02632630|"~     Patients with severe malnutrition risk are 7.4 times more likely to die in hospital than~     well-nourished patients, and carry a 30-day readmission rate of >46%. Although malnutrition~     is common and is associated with extremely poor outcomes, it is neglected and undertreated.~     This is a randomized controlled pilot trial to rapidly identify at-risk hospitalized medical~     patients, and then provide nutritional supplementation in hospital and after discharge for 28~     days. In select at-risk patients, 5 days of nutrition delivered through a peripheral vein~     will be used in addition to oral nutritional supplementation.~   "
71381|NCT02632617|"~     Preoperative detection of combined coronary artery disease by invasive coronary angiography~     (ICA) is recommended in American Heart Association (AHA)/American College of Cardiology (ACC)~     guidelines for most patients (>40 yrs male or postmenopausal female) scheduled for heart~     valve surgery, but the low incident rate of coronary artery disease implied guidelines for~     the vast majority who ultimately will not undergo revascularization. Computed tomography~     angiography (CTA) has emerged as an alternative diagnosis procedure, which has the following~     advantages: non-invasive, low cost, provide information of lung and mediastinum. Our study is~     to evaluate the feasibility of computed tomography, instead of conventional invasive coronary~     angiography in evaluating coronary artery lesion prior to the heart valvular operation.~   "
71382|NCT02632604|"~     The purpose of this study is to investigate the effect of a neuroplasticity-based~     computerized cognitive training for the elderly~   "
71383|NCT02632578|"~     The aims of this study are:~        1. to investigate if HIV infection alters the antibody responses to influenza and~        2. to assess the ability of licensed influenza vaccine to induce functional~          non-neutralising antibodies in HIV-infected and HIV-uninfected subjects.~   "
71384|NCT02632565|"~     In this study, investigators compared the efficacy of intra-articular 0.5% lidocaine and~     saline injection on pain, stiffness and physical function in patients with osteoarthritis.~   "
71385|NCT02632552|"~     Transition from hospital to home places patients in jeopardy of adverse events and increases~     their risk for rehospitalization. CHF is the most prevalent chronic condition among U.S.~     adults and COPD is the third leading cause of death in the U.S. Both CHF and COPD represent~     significant burdens for the VHA healthcare system. Care transitions can be supported through~     multi-component interventions, but are costly to implement. Virtual nurses provide an~     effective medium for explaining health concepts to patients, and previous work indicates~     patients find virtual nurses acceptable. The investigators will implement and evaluate a~     virtual nurse intervention to provide automated, tailored, and timely support to Veterans~     transitioning from hospital to home. As effective care transition interventions incorporate~     both inpatient and outpatient components, the virtual nurse will first engage with patient~     onscreen during their inpatient stay and then via text message post-discharge. This project~     has the potential to improve the care transition experience for patients, caregivers and~     healthcare providers.~   "
71386|NCT02632539|"~     Ventilator-associated pneumonia (VAP) is the most frequent infection occurring in patients~     who are admitted to the ICU. The accumulation of respiratory secretions in the subglottic~     space is a well-proven cause of VAP. Investigators invented a manual method with high-flow~     air produced by resuscitator to impinge secretion from the subglottic space to oral cavity.~     Investigators want to compare it with conventional method which uses a special intubation~     tube with an independent dorsal lumen to suction subglottic secretion.~   "
71387|NCT02632526|"~     This is a phase I, randomised, single-blind, placebo-controlled, first-in-human (FIH) single~     and multiple ascending dose study consisting of two parts (Part A [SAD] and Part B [MAD]) to~     assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD5718 in healthy~     male subjects~   "
71429|NCT02631980|"~     Hepcifer Trial is designed to assess the value of iv iron administration immediately after~     liver surgery and consequences of inflammation on iron balance. Fifty patients will be~     randomized in two treatment groups. Patients will be assigned to receive either iv iron or~     placebo immediately after liver resection surgery. Biological inflammation parameters,~     hemoglobin, serum iron and hepcidin levels will be assessed prior to surgery and at day 1, 3,~     7, 15 and 30 after surgery.~   "
71926|NCT02625480|"~     This is a single arm, open-label, multi-center, phase 1/2 study, to determine the safety and~     efficacy of KTE-C19, an autologous anti-CD19 chimeric antigen receptor (CAR)-positive T cell~     therapy, in relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL) in pediatric~     or adolescent subjects.~   "
71388|NCT02632513|"~     The aim of this study was to compare the success after endodontic treatment performed with or~     without continuous ultrasonic irrigation.~      70 Mandibular molars with diagnosis of pulpal necrosis and with periapical radiolucency were~     randomly assigned into two treatment groups- continuous ultrasonic irrigation (CUI) and~     syringe irrigation (SI). Standard nonsurgical endodontic treatment was performed on both~     groups under rubber dam isolation with 0.02 taper ISO stainless steel hand files using step~     back technique. In both groups, 5 ml of 5.25% sodium hypochlorite was used as irrigant after~     each instrument. After root canal instrumentation, canals were irrigated with 5 ml of 17%~     EDTA solution for 1 minute. In SI group, canals were flushed with 15ml of 5.25% sodium~     hypochlorite using a 27 gauge needle while final irrigant was delivered using a continuous~     ultrasonic irrigation device in CUI group. An inter-appointment dressing of calcium hydroxide~     was given and patient was recalled after one week and canals were obturated with the Gutta~     Percha. Immediate postoperative radiograph was then taken, followed by radiographs at 3, 6, 9~     and 12 months.~   "
71389|NCT02632500|"~     The aim of the study is to verify whether the inclusion of breaks of different frequency and~     duration during the hands-only cardio-pulmonary resuscitation (CPR) could increase chest~     compressions quality during an 8-minutes scenario.~   "
71390|NCT02632487|"~     This study will evaluate the feasibility and efficacy of combining a traditional, structured~     exercise intervention with an innovative intervention designed to decrease sedentary behavior~     and increase non-exercise physical activity (NEPA).~   "
71391|NCT02632474|"~     The purpose of this study is to determine efficacy of the combination of low dose of~     Tenofovir, Efavirenz and Lamivudine in treating HIV-infection.~   "
71392|NCT02632461|"~     The purpose of the study is to test the effectiveness of two different weight loss~     interventions. Both of these interventions will provide weight loss information through twice~     weekly audio podcasts. In addition to the podcasts, participants will be asked to track their~     diet using either a wearable device on their wrist or through an app on their smartphone.~   "
71393|NCT02632448|"~     The main purpose of this two-part study is to evaluate the safety and efficacy of the study~     drug known as LY2880070 in participants with advanced or metastatic solid tumors.~   "
71394|NCT02632435|"~     In the REaCT-Vascular Access Trastuzumab study (REaCT-VA), the investigator will use a novel~     method to allow comparisons of established standard of care vascular access strategies using~     the integrated consent model as part of a pragmatic clinical trial. The investigator wishes~     to address a non-pharmacologic issue regarding standard of care vascular access devices.~     Peripherally inserted central catheters (PICC lines) versus subcutaneously implanted devices~     (PORTs).~   "
71395|NCT02632422|"~     The purpose of this study is to determine how the nervous system controls leg muscles is~     important for walking in subjects following a spinal cord injury (SCI) and how they may be~     affected by brief periods of low oxygen inhalation over time.~   "
71396|NCT02632409|"~     The purpose of this study is to determine the effectiveness and safety of Nivolumab compared~     to placebo in participants who have undergone radical surgery for invasive urothelial cancer.~   "
71397|NCT02632396|"~     This phase I/II trial studies the side effects and best dose of ixazomib citrate (ixazomib)~     when given together with rituximab and to see how well they work after stem cell transplant~     in treating patients with mantle cell lymphoma that are no longer showing signs or symptoms~     of cancer. Ixazomib may stop the growth of cancer cell by blocking enzymes needed for cell~     growth. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer~     cells to grow and spread. Giving ixazomib together with rituximab after transplant may help~     prevent the cancer from coming back.~   "
71398|NCT02632383|"~     A multicenter randomized controlled trial testing the app Young with Diabetes~   "
71399|NCT02632370|"~     In support of the US marketing application for 5-ALA, this single arm trial is being~     conducted to establish the efficacy and safety of Gliolan® (5-ALA) in patients with newly~     diagnosed or recurrent malignant gliomas. The hypothesis of the study is Gliolan® (5-ALA), as~     an adjunct to tumor resection, is safe and that real-time tissue fluorescence correlates with~     malignant histopathology. The primary objective in this single arm study is to define the~     positive predictive value (PPV) of Gliolan®-induced PPIX fluorescence for malignant tumor at~     the time of initial resection and first use of FGS by taking a biopsy of tissue presenting~     with red fluorescence when observed during the course of resection of new or recurrent~     malignant gliomas. The functionality and performance reliability of the blue light excitation~     microscope platforms will be assessed.~   "
71400|NCT02632357|"~     Study Design: Longitudinal Experimental Study~      Objective: Analyze the relationship between Upper Limb Neural Tension Test (ULNTT1) and~     cervico-thoracic spine biomechanics using a new motion-capture spine movement data analyzing~     model based on Least Square Approximation.~      Summary of Background Data: ULNTT1 is a test able to determine cervical nerve roots and~     brachial plexus displacement within their interface structures. No studies were conducted~     about ULNTT1 and cervico-thoracic spine motion patterns relationship.~      Methods: 12 subjects with ULNTT1 asymmetry > 10° (AS group) and 11 subjects with ULNTT1~     symmetry (S group) at clinical tests will be enrolled for the study. Subjects will be~     analyzed for ULNTT1 with an electrogoniometer using two parameters, one operator and one~     patient-dependent. Fine lateral bending cervico-thoracic spine motion patterns will be~     collected with motion-capturing technique and data will be analyzed with Least Square~     Approximation tools. Subjects with impairments in cervico-thoracic spine mobility will~     undergo to correction of those with spinal manipulative therapy. ULNTT1 and spine mobility~     will be so re-evaluated with same methods.~   "
71401|NCT02632344|"~     This research study is evaluating an immune modulatory agent as a possible treatment for~     patients with Recurrent Respiratory Papillomatosis (RRP) with significant disease involving~     the larynx, trachea, and/or lungs. The investigators will be using Pembrolizumab as the~     treating agent.~   "
71402|NCT02632331|"~     The objective of this study is to evaluate the effect of food on the pharmacokinetics and~     safety after administration of ASP8825 in healthy non-elderly adult male subjects.~   "
71440|NCT02631824|"~     Randomized clinical trial to assess if the use of augmentation in the treatment of fragility~     intertrochanteric hip fractures improves radiologic and clinical outcomes in patients aged 65~     years or older 1 year after surgery~   "
71403|NCT02632318|"~     One of the most physiologically demanding things that older people do every day is to get up~     in the morning. After spending a night laying flat, where the blood distributes evenly across~     the body, when they stand in the morning (and the blood rushes to their feet), their~     cardiovascular system may not be able to compensate and maintain blood flow to the brain.~     This phenomenon is known as orthostatic or postural hypotension. The investigators have found~     in a group of young individuals that use of a dawn-simulation light that gradually wakes the~     brain is able to increase cardiovascular tone prior to arising. The goal of this experiment~     is to determine whether this dawn simulation light is able to increase cardiovascular tone in~     older adults such that they would have reduced or absent postural hypotension when they~     awaken in the morning. This would greatly reduce the risks of falls and their associated~     morbidities in older adults.~   "
71404|NCT02632305|"~     You are being asked to take part in this study because you have a biliary cancer that is~     incurable and has spread to other organs. Chemotherapy is often used to help shrink the~     cancer temporarily and may improve survival. In Canada, the combination of gemcitabine and~     cisplatin is the chemotherapy combination used to treat biliary cancer that has spread. There~     is no other known treatment for biliary cancer that has spread to other organs. It is hoped~     that this new combination of drugs (nab-paclitaxel, gemcitabine, and cisplatin) will improve~     the tumor shrinkage rate.~      This study is being done because we do not know whether 2 or 3 chemotherapy drugs is better~     to treat biliary cancers.~      We hope to learn whether giving nab-paclitaxel, gemcitabine, and cisplatin together in~     patients with biliary cancer can increase tumor shrinkage without too many side effects.~      The purpose of this study is to find out what effects (good and bad) nab-paclitaxel,~     gemcitabine, and cisplatin has on you and your biliary cancer.~   "
71405|NCT02632292|"~     Prospective, randomized, controlled, multicenter, open-label study to compare~     everolimus-eluting bioresorbable vascular scaffolds to everolimus-eluting stents in patients~     with diabetes mellitus.~   "
71406|NCT02632279|"~     The purpose of this study is to assess the effect of tryptophan depletion on mood and~     behavior in Parkinson's disease (PD) patients treated with deep brain stimulation (DBS) of~     the subthalamic nucleus (STN). By doing this, the investigators hope to be able to identify~     risk factors for and mechanisms underlying psychiatric side effects of STN DBS. The study~     will be an intervention study with a placebo controlled, randomized cross-over design.~   "
71407|NCT02632266|"~     The purpose of this study is for the researchers to examine the safety and efficacy of liquid~     human milk fortifier (HMF) in moderately preterm infants compared to powdered human milk~     fortifier.~   "
71408|NCT02632253|"~     Patients with congenital heart disease have long been discouraged from participating in~     physical exercise which has led to impaired exercise capacity in this population. Since low~     physical and cardiorespiratory fitness has been shown to be a predictor for hospitalization~     and mortality in grown-up patients with congenital heart disease (GUCH), aerobic endurance~     training has been recommended recently to improve exercise capacity. The aim of this study is~     to compare two types of training, namely high-intensity interval training (HIIT) and~     moderate-intensity continuous exercise (MICE), with regard to improving exercise capacity~     without adverse effects on heart structure, function and rhythm in the setting of a 12-week~     outpatient cardiac rehabilitation (CR) program in GUCH with a remaining pathology involving~     the right and/or left ventricles. Primary endpoint will be change in exercise capacity~     (maximal oxygen consumption) over the 12-week CR. Secondary endpoints will be changes of the~     right or left ventricles as well as vascular function.~      Patients with GUCH and reduced function of the right ventricle will be recruited and informed~     about the study within the first two weeks of CR. At the end of week 3 of the CR with~     supervised MICE, randomization to 9 weeks of twice weekly either HIIT or MICE takes place.~      MICE training is performed at an intensity of 70-85% of maximum heart rate (HRmax) for 38~     min. HIIT consists of four 4 min bouts of high-intensity exercise (90-95% of HRmax),~     interspersed by 3 min low-intensity intervals (50-60% of HRmax). All patients complete one~     additional endurance activity per week in their own time with a duration of 30-60 min at~     moderate intensity monitored by their smart phone.~      Change in peak oxygen uptake as well as maximal exercise capacity at the end of an~     incremental cardiopulmonary exercise test will be assessed between week 3 and 12. Vascular~     function will be assessed at the same time. Volumes and function of the right and left~     ventricles will be measured by cardiac magnetic resonance imaging (CMR) upon inclusion into~     the study and at completion of the intervention. Furthermore, laboratory markers for heart~     failure as well as occurrence of irregular fast heart beats will be assessed.~   "
71409|NCT02632240|"~     The aim of this study is to compare the efficacy of dental root coverage using the tunnel~     technique with connective tissue graft (CTG) and the same technique with collagen matrix for~     treatment of multiple gingival recessions Miller Class I and II.~      This study is a randomized-controlled clinical trial of 6 months duration.~   "
71410|NCT02632227|"~     The purpose of this study was to evaluate the clinical usefulness of TFU (transfontanel~     ultrasound)for the prediction of fluid responsiveness in children undergoing congenital heart~     surgery.~   "
71411|NCT02632214|"~     The aim of this study is to evaluate cerebral asymmetry for face processing in a group of~     profoundly deaf participants and a group of hearing controls by the mean of fMRI measure. To~     this end, we present chimeric faces (faces split into different halves), entire faces, or~     faces presented in divided visual field, and subjects perform a gender categorization task~     while lying in a fMRI scanner.~      It is expected to find a reduced cerebral asymmetry in the Fusiform Face Area in deaf in~     comparison with hearing participants.~   "
71412|NCT02632201|"~     Objectives:~      The purpose of this study is to evaluate the safety and efficacy of PIK-HER2 cells in the~     treatment of advanced Her2 high expressed gastric cancer with liver metastasis patients.~      Methods:~      This study designs a novel therapy using PIK-HER2 cells. 40 Her2 positive patients with liver~     metastasis from gastric cancer will be enrolled. They are randomly divided into dendritic~     cell-precision multiple antigen T cells (DC-PMAT) group and PIK-HER2 cells group. Both~     DC-PMAT treatment and PIK-HER2 cells treatment will be performed every 3 weeks with a total~     of three periods. The mail clinical indicators are Progression-Free-Survival and Overall~     Survival.~   "
71413|NCT02632188|"~     Objectives:~      The purpose of this study is to evaluate the safety and efficacy of radical surgery combined~     with dendritic cell-precision multiple antigen T cells in reducing the recurrence and~     metastasis of liver cancer~      Methods:~      This study designs a novel therapy using dendritic cell-precision multiple antigen T cells.~     60 postoperative patients of hepatocellular carcinoma will be enrolled. They are randomly~     divided into postoperative routine therapy group and dendritic cell-precision multiple~     antigen T cells combined with postoperative routine therapy group. Dendritic cell-precision~     multiple antigen T cells treatments will be performed every 3 weeks with a total of three~     periods. The mail clinical indicators are Progression-Free-Survival and Overall Survival.~   "
71414|NCT02632175|"~     This study assesses the long-term safety and efficacy of adalimumab in pediatric subjects~     with ulcerative colitis.~   "
71418|NCT02632123|"~     Idiopathic pulmonary fibrosis (IPF) is a progressing scarring disease of the lungs with an~     average survival of only 30-36 months since the time of diagnosis. The clinical course of IPF~     is highly variable, with some patients remaining stable for a prolonged period of time, even~     in the absence of medical treatment, while others experience rapid and relentless~     progression. In some cases, the clinical course consists of a stepwise rather than steady~     decline, with periods of stability alternating with acute respiratory worsening. The~     variability in clinical course makes it challenging to define prognosis in these patients~     and, importantly, to determine the right time window for lung transplantation (LTx) referral,~     listing and priority status on the waiting list.~      The risk stratification score (RISE) is a new staging system for IPF based on the MRC dyspnea~     score, on physiology variables (pulmonary function tests) captured in the Composite~     Physiologic Index (CPI), and on the 6-minute walk distance. RISE showed to predict survival~     in newly diagnosed patients with IPF better than any other individual clinical, functional or~     radiographic variable. RISE also predicted survival on the waiting list in patients assessed~     and listed for LTx.~   "
71419|NCT02632110|"~     The purpose of this study is to determine the viability of microneedle lesion preparation~     (MN) to enhance treatment benefit when performed prior to ALA PDT to an actinic keratosis~     (AK) field on the face.~   "
71420|NCT02632097|"~     This is a prospective, randomized double-blinded study to find out if mesh fixation with~     n-butyl-2-cyanoacrylate (NBCA) are more painless than conventional mesh fixation with sutures~     in inguinal hernia operation (Lichtenstein procedure) in day-case surgery. Our hypothesis is~     that glue fixation is safe, simple and fast method compared to conventional Lichtenstein~     technique.~   "
71421|NCT02632084|"~     A study to followup patients that have previously been treated for pituitary tumours with~     either photodynamic therapy or placebo in a previous trial. The study aims to determine~     whether photodynamic therapy has any long term effect on tumour size, visual fields or~     endocrinological function.~   "
71422|NCT02632071|"~     This is a non-randomized phase 1 trial designed to determine the MTD and evaluate the safety~     and tolerability of ACY-1215 with nab-paclitaxel. Based on the activity profile of ACY-1215~     in breast cancer, corresponding biomarker availability with the HDAC6 MR score, and its~     potential synergy with taxanes, these data support the rationale for testing the ability of~     ACY-1215 to improve the response rate for patients with metastatic breast cancer in~     combination with standard taxane chemotherapy.~   "
71423|NCT02632058|"~     Tinnitus is the acoustic perception of sound without any physical source. It is estimated~     that 15-21% of adults develop a Tinnitus, which can cause serious distress and debilitation~     in all aspects of daily life of the affected.~      There is currently no evidence for a successful treatment of tinnitus. While one treatment~     approach involves sound-based therapies, e.g. tinnitus retraining therapy. The treatment~     aspect in our setting involved cognitive behavioural therapy.~   "
71424|NCT02632045|"~     This is a randomized trial for patients with metastatic hormone receptor (HR)-positive human~     epidermal growth factor receptor 2 (HER2)-negative breast cancer who have progressed on an~     aromatase inhibitor plus a CDK4/6 inhibitor (either palbociclib or ribociclib) to either~     fulvestrant alone or fulvestrant with ribociclib (LEE-011). The purpose of the trial is to~     determine whether there is continued benefit for patients to remain on a CDK4/6 inhibitor at~     the time of switching anti-estrogen therapy. As ribociclib and palbociclib have a similar~     toxicity and drug profile and mechanism of action, we feel that it is appropriate for~     patients to receive either drug with an aromatase inhibitor prior to randomization.~   "
71425|NCT02632032|"~     Therapeutic education is central to the management of diabetes, especially in children and~     adolescents. Camps represent an ideal environment for education. During camps, the campers~     receive both theoretical and practical information intended to improve their understanding~     and self-management of diabetes. The metabolic impact of diabetes camp is little known among~     children and adolescents living with type 1 diabetes in sub-Saharan Africa. The aimed of this~     study was to assess the changes in glycemic control and insulin doses in a group of children~     and adolescents living with type 1 diabetes in Cameroon during and after camp.~   "
71426|NCT02632019|"~     Objectives:~      The purpose of this study is to evaluate the safety and prognosis of dendritic cell-precision~     T cell for neo-antigen in the treatment of advanced biliary tract malignant tumor.~      Methods:~      This study designs a novel therapy using dendritic cell-precision multiple antigen T cells.~     40 patients will be enrolled. They are randomly divided into gemcitabine group and dendritic~     cell-precision T cell for neo-antigen combined with gemcitabine group. Gemcitabine treatments~     will be performed once a week with a total of six times. Dendritic cell-precision T cell for~     neo-antigen combined with gemcitabine treatment: Gemcitabine: once a week with a total of six~     times before 60 days prior to the start of drawing blood. Dendritic cell-precision T cell for~     neo-antigen: once per 3 weeks with a total of three periods. The mail clinical indicators are~     Progression-Free-Survival and Overall Survival.~   "
71427|NCT02632006|"~     Objectives:~      The purpose of this study is to evaluate the safety and efficacy of PIK-PD-1 Cells in the~     treatment of advanced Hepatocellular Carcinoma.~      Methods:~      This study designs a novel therapy using PIK-PD-1 cells. 40 patients with advanced~     Hepatocellular Carcinoma will be enrolled. They are randomly divided into dendritic~     cell-precision multiple antigen T cells (DC-PMAT) group and PIK-PD-1 cells group. Both~     DC-PMAT treatment and PIK-PD-1 cells treatment will be performed every 3 weeks with a total~     of three periods. The mail clinical indicators are Progression-Free-Survival and Overall~     Survival.~   "
71428|NCT02631993|"~     Cure of leukemia after hematopoietic stem cell transplantation (HSCT) is sustained by the~     anti-leukemic effect of the grafted cells (graft-versus-leukemia (GVL)). However, it is not~     known whether the tumor-immunity is affected by photochemotherapy (psoralene~     photosensitization and ultraviolet light radiation) administered to attenuate graft-versus~     host disease (GVHD).~      The present study aim to investigate what happens to the GVL after photochemotherapy of aGVHD~     in a predominantly retrospective setting with 10-years follow-up after HSCT~   "
71464|NCT02631512|"~     The aim of the current study is to support the performance and safety of Woulgan® in the~     treatment of diabetic foot ulcer in comparison with the commercially available hydrogel~     Intrasite. Healing and untoward medical events to be evaluated.~   "
74005|NCT02598206|"~     The purpose of this study is to evaluate the effect of food intake on PF-04136309~     pharmacokinetics (PK) following a single dose at 1000 mg.~   "
71430|NCT02631967|"~     Kono and collegues have described a new anastomotic technique to restore bowel contintuity~     after ileocecal resection for Crohn's disease (CD).~      This tecnique implies a hand-sewn ileocolic anastomosis, that involves exclusively the~     antimesenteric side of the bowel and that functionally acts as an end-to-end anastomosis.~      In a retrospective study, the authors have shown that this anastomotic tecnique, when~     compared to stapled side-to-side anastomosis, significantly reduces the severity of~     endoscopic recurrence at 1 year after surgery and the rate of reoperation for anastomotic~     recurrence at 5 years after surgery.~      Aim of this trial is to compare the outcomes of the Kono anastomosis with the ones achieved~     by the stapled side-to-side anastomosis, within a prospective randomized study.~   "
71431|NCT02631954|"~     Phase I Clinical Trial for Comparison of Pharmacokinetic Characteristics of Vorico Injection~     200mg(Voriconazole) and Vfend® IV 200mg for Single Dose Crossover Intravenous Infusion in~     Healthy Volunteers~   "
71432|NCT02631941|"~     The pharmacokinetics study aims to evaluate the safety of Z7200 (budesonide/formoterol) in~     comparison with Symbicort Turbohaler (budesonide/formoterol), assessing the bioequivalence of~     the two products. Namely the study will compare the total systemic bioavailability (as an~     indicator of safety), and it will compare the pulmonary bioavailability (as a possible~     surrogate indicator of efficacy). This study will be performed in healthy subjects.~   "
71433|NCT02631928|"~     This study in healthy volunteers aims to demonstrate similar PK and PD properties of the new~     human biphasic insulin, Julphar Insulin 30/70 and an already approved reference insulin,~     Huminsulin® Profil III. All participants will receive both study treatments on two separate~     dosing days.~   "
71434|NCT02631902|"~     Type 2 diabetes is a chronic disease that affects approximately 13% of Portuguese population~     and is associated with a high cardiovascular mortality by coronary artery disease and~     cerebrovascular disease and with a serious decline on well-being. Lifestyle changes are~     widely recommended to the control of type 2 diabetes and its complications. This study aims~     to analyse the effects of different community-based lifestyle programs (exercise or exercise~     plus dietary intervention) on health and well-being in patients with type 2 diabetes.~   "
71435|NCT02631889|"~     Major lung resection is one of the most common procedures performed in thoracic surgery, but~     it may involve considerable bleeding and the occasional need for a transfusion and/or~     reoperation for bleeding in specific cases. In addition, lysis of pleural-parenchymal~     adhesions and dissection can represent a challenge in patients who have undergone~     chemotherapy and/or radiation therapy, and in patients with bronchiectasis or COPD. Several~     intraoperative methods have been used to manage blood loss, including topical haemostatic~     agents, bipolar sealers or electrocautery. Transcollation technology (TT) consists of a~     disposable bipolar sealer that uses a radiofrequency coagulation system to deliver a saline~     solution that provides haemostatic sealing of soft tissue and bone and provides localized~     cooling without charring. Blood loss reduction has been previously described in several~     fields of surgery.~      The primary end-point of the proposed trial is to assess if the ability of Transcollation~     Technology in reducing the proportion of patients showing bleeding perioperatively within the~     setting of a prospective randomized controlled trial.~      The secondary end-point is to assess if Transcollation Technology is able to improve~     postoperative outcomes reducing the length of hospital stay.~   "
71436|NCT02631876|"~     This is a Phase 3, open label, randomized study designed to compare the safety and efficacy~     of IMGN853 to that of selected single-agent chemotherapy (Investigator's choice) in women~     with platinum-resistant FR-alpha positive advanced EOC, primary peritoneal cancer and/or~     fallopian tube cancer.~   "
71437|NCT02631863|"~     This trial will study the effectiveness of photodynamic therapy with aminolaevulinic acid for~     the treatment of patients with HPV+ low grade cervical intraepithelial neoplasia (LSIL;CIN1).~   "
71438|NCT02631850|"~     The current proposal aims to conduct a multi-site randomized controlled trial comparing~     virtual-reality gaming delivery of Constraint Induced Movement therapy (CI therapy) with (1)~     traditional clinic-based CI therapy of equal total active therapy duration and (2) a control~     group equating the dose of in-person therapy. Individuals with chronic stroke will be~     randomized to one of four different interventions: (1) traditional clinic-based CI therapy~     (35 therapist/client contact hours), (2) therapist-as-consultant virtual reality CI therapy~     (5 therapist/client contact hours in the clinic and 15 hours of independent game play at~     home), (3) therapist-as-consultant virtual reality CI therapy with additional therapist~     contact via telerehabilitation (5 therapist/client contact hours in the clinic, 4 therapist~     contact hours via teleconference, and 15 hours of independent game play in the home), and (4)~     5 hours of standard occupational therapy. After 6-month follow-up, individuals assigned to~     standard OT/PT will cross over to a modified gaming therapy condition (a stand-alone~     application of the rehabilitation game without additional therapist contact).~   "
71439|NCT02631837|"~     Objective: To compare vNOTES (vaginal Natural Orifice Transluminal Endoscopic Surgery) and~     established total laparoscopic hysterectomy for successful removal of a non-prolapsed uterus~     in women due to undergo hysterectomy for benign gynecological pathology.~      Study design: Randomized controlled/single~     center/single-blinded/parallel-group/non-inferiority/efficacy trial.~      Study population: All women aged 18 to 70 years regardless of parity with a non-prolapsed~     uterus and a benign indication for hysterectomy.~      Randomization: Women will be randomly allocated to undergo one of two techniques for removal~     of the uterus immediately before surgery by using a computer generated randomization list. We~     will use stratified randomization according to the estimated uterine size on clinical~     examination.~      Intervention: Women will be treated by a surgeon who is not blinded to the treatment~     allocation and who is equally skilled in performing both techniques. In the intervention~     group a vNOTES technique will be used.~      Control: In the control group surgery will be done by a classical laparoscopic technique.~      Main study parameters/endpoints:~      Primary study outcome parameters: successful removal of the womb with the intended approach~     without conversion to an alternative approach.~      Secondary outcomes: the proportion of women admitted to the in-hospital ward for at least one~     night observation, based on their own preference; postoperative pain scores using a VAS~     (Visual Analogue Scale) measured between day 1 till 7 by the participating women following~     surgery and the total amount of analgesics used as described in the standardized pain~     treatment protocol from day 1 till 7; postoperative infection defined by lower abdominal pain~     with fever > 38°C and positive clinical signs or laboratory findings; per- or postoperative~     complications according to the Clavien- Dindo classification detected during the first six~     weeks of surgery; hospital readmission within 6 weeks following surgery; duration of the~     surgical procedure; incidence and intensity of dyspareunia recorded by the participants at~     baseline, 3 and 6 months by self-reporting using a simple questionnaire and VAS (Visual~     Analogue Scale); sexual wellbeing recorded by the participants at baseline, 3 and 6 months by~     SSFS (Short Sexual Functioning Scale); health-related quality of life, at baseline, at 3 and~     6 months by self-reporting the EQ-5D-3L questionnaire; direct and indirect costs incurred up~     to 6 weeks after the hysterectomy associated with both procedures.~   "
71441|NCT02631811|"~     Several studies have shown that patients with acute leukemia have many symptoms during~     disease These symptoms decrease the quality of life and may even appear or worsen other~     symptoms such as depression Several studies point to the involvement of supportive care and~     palliative care is delayed in these patients The aim of this study is to evaluate the impact~     on the quality of life of an early and standardized involvement of a support / palliative~     care team for patients with acute leukemia in first relapse compared to a control group .~   "
71442|NCT02631798|"~     Previous with methylene blue suggested that oral administration may be superior to~     conventional spray catheters. The main advantages claimed were better staining due to longer~     exposure to the dye, more uniform staining due to normal position of the intestines (during~     conventional chromocolonoscopy, patients are lying on one side), and a quicker and more~     comfortable procedure for the patients and endoscopy personnel.~      Using food-grade dyes would enable higher dye loads and lower systemic side effects.~      Food grade dyes will be administered orally during preparation with KleanPrep (total amount~     of 4 liters) in patients undergoing screening colonoscopy.~      On day 1 patients will drink 3 l of the preparation solution, the last liter together with~     the last dose of dye will be administered 5 hours before scheduled colonoscopy.~      Primary endpoints:~        -  quality of mucosal staining of colon (assessed by questionnaire)~      Secondary endpoints:~        -  adenoma detection rate~        -  adverse events~        -  time of colonoscopy~   "
71443|NCT02631785|"~     The proposed research aims to isolate brain-based information-processing mechanisms~     implicated in perturbed fear learning and extinction characteristic of pediatric anxiety.~      The study will focus on the therapeutic relevance of dysfunction in fear learning and~     extinction for treatment by examining the associations between brain functioning and response~     to exposure intervention in anxious children.~   "
71444|NCT02631772|"~     The predominant remaining questions for post-transplant treatment of HCV in the DAA era are~     whether a ribavirin-free regimen is possible and whether pre-emptive treatment is now a~     potential option to prevent long-term damage to the allograft.~      Our aim is to provide answers to these primary questions with our multicenter, prospective,~     randomized, open-label intent-to-treat phase IV study~   "
71445|NCT02631759|"~     Haemorrhagic strokes represent about 10-15 % of all strokes and 30,000 cases per year in~     France. The 30-day death rate ranges from 30 to 55% (50% of deaths occurring within 48~     hours). Currently, no urgent medical or surgical treatment has been shown to improve~     functional or vital prognosis. Clinical epileptic seizures frequency in acute intracerebral~     haemorrhage has been estimated between 4% and 16% but the occurrence of subclinical epileptic~     seizures (detected on the electroencephalogram (EEG) only) could be much more frequent (28 %~     to 40 %).~      Some studies have suggested that early repeated epileptic seizures may be associated with a~     worse neurological prognosis. Repeated epileptic seizures occurring in the acute phase may~     increase brain oedema, worsen, hypoxia and may lead to cellular death in the injured brain~     tissue. Thus, prevention of early epileptic seizures may improve neurological outcome.~     However, the efficacy of a systematic prophylactic antiepileptic treatment on clinical and~     subclinical epileptic seizures has not been evaluated in the setting of intracerebral~     haemorrhage. The current European guidelines recommend the use of antiepileptic drugs only~     when epileptic seizures occur.~      Primary objective: PEACH is a randomized controlled trial aiming at evaluating the impact of~     systematic prophylactic antiepileptic treatment with levetiracetam versus placebo in acute~     supratentorial spontaneous intracerebral haemorrhage. The primary endpoint is the occurrence~     of at least one clinical or electrical epileptic seizure recorded on continuous 48h holter~     EEG.~      Secondary Objectives:This study also aims to assess:~      Ä The efficacy of prophylactic treatment with levetiracetam on the number of EEG seizures, on~     the total duration of epileptic seizures continuously recorded on EEG, on the occurrence of~     some paroxysmal EEG patterns, on the number of clinical seizures occurred during 72 hours of~     diagnosis, on the occurrence of early (day-0 to day-30 ) and late (from day-30 to 12 months)~     clinical seizures, on the functional prognosis at 3 , 6 and 12 months evaluated by the~     modified Rankin scale , on the cerebral oedema and mass effect evaluated by comparing the~     admission brain CT scan with the control CT scan performed at 72 hours, on the neurological~     status as assessed by the National Institute of Health Stroke Scale at 72 hours , 1 month and~     3 months and on the quality of life measured by the Stroke impact Scale at 3, 6 and 12~     months.~      Ä The frequency of side effects related to treatment with levetiracetam (anxiety and~     depression assessed by the Hospital Anxiety and Depression Scale at 1 and 3 months) Sample~     Size: 104 patients will be recruited over 2 years.~   "
71446|NCT02631746|"~     This phase II trial studies how well nivolumab works in treating patients with human T-cell~     leukemia virus (HTLV)-associated T-cell leukemia/lymphoma. Nivolumab is an antibody, which is~     a type of blood protein that tags infected cells and other harmful agents. Nivolumab works~     against a protein called programmed cell death (PD)-1 and may help the body destroy cancer~     cells by helping the immune system to keep fighting cancer.~   "
71447|NCT02631733|"~     This phase I trial studies the side effects and best dose of veliparib when given together~     with liposomal irinotecan in treating patients with solid tumors. Liposomal irinotecan and~     veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth.~   "
71448|NCT02631720|"~     While many patients experience benefits from transplant, complications such as infections and~     lung rejection may affect long term survival and quality of life. In this study doctors are~     looking at a complication called Chronic Lung Allograft Dysfunction (CLAD). CLAD is thought~     to be chronic rejection of the lung by the immune system and is the leading cause of death~     after lung transplantation.~      The purpose of this study is to help doctors determine:~        -  why some people get CLAD and others do not~        -  how patients who get CLAD do after CLAD is diagnosed~        -  how CLAD may affect quality of life~   "
71449|NCT02631707|"~     All patients in CMDHB eligible for bariatric surgery are given a weight loss goal prior to~     surgery. It is unknown what the most effective diet is to lose weight, while still preserving~     muscle mass. The diet must also be acceptable and adhered to by patients. The aim of this~     study is to find out if a diet that is higher in protein and lower in carbohydrate than the~     standard Ministry of Health guidelines will have a greater effect on weight loss,~     preservation of lean muscle mass, surgical recovery score, adherence and acceptability.~   "
71450|NCT02631694|"~     Animal and human fear conditioning studies have repeatedly shown that administering~     propranolol before or after retrieval of a previously acquired fear results in an elimination~     of the fear expression. This approach, known as disruption of fear memory reconsolidation, is~     a promising new avenue for treating anxiety disorders. The present study aims to test its~     efficacy in patients with panic disorder.~   "
71451|NCT02631681|"~     Exercise intervention for men with prostate cancer on androgen deprivation therapy.~   "
71465|NCT02631499|"~     This study is designed to prospectively evaluate whether post-hepatectomy adjuvant~     transcatheter arterial chemoembolization (TACE) is effective in reducing early recurrence in~     HCC patients with preoperative CTC ≥2.~   "
71807|NCT02627040|"~     The main goal of the study is to determine which cephalomedullary nail results in a better~     functional outcome for the patient with an unstable intertrochanteric hip fracture. Subjects~     will be randomized to fixation with either a Gamma3 cephalomedullary nail or an InterTan~     cephalomedullary nail. Outcomes will be reviewed over a 12 month follow-up period.~   "
71452|NCT02631668|"~     IDA patients ofen receive ferrous succinate treatment to speed up the recovery of anemia, the~     doctor will prescribe ferrous succinate with or without vitamin C according to their own~     preferences. In theory, only the divalent iron can be absorbed in duodenum and upper jejunum,~     vitamin C can oxidize ferric iron into divalent iron and maintains a certain degree of~     acidity in the intestine, and then promotes the absorption of iron. In current clinical~     practice, it's lack of randomized controlled trial(RCT) about the efficacy and safety of~     vitamin C for iron supplementation in patients with IDA. In this study, the efficacy and~     safety of vitamin C for iron supplementation in adult IDA patients are explored by RCT. The~     dosage regimens of ferrous succinate with or without vitamin C are randomly assigned to~     patients who meet the inclusion criteria, and these patients are followed up every two weeks.~     On the one hand, whether the addition of vitamin C can accelerate the recovery of anemia is~     evaluated, on the other hand, whether the addition of vitamin C can increase the incidence of~     gastrointestinal tract discomfort is aslo appraised , the discomfort include vomiting,~     nausea, abdominal pain, diarrhea and constipation. We hypothesis that vitamin C can increase~     the absorption of iron and accelerate the recovery of anemia, it also increases incidence of~     gastrointestinal adverse events because of increased iron absorption at the same time.~   "
71453|NCT02631655|"~     18F-FDOPA PET is expensive. It is mandatory therefore to assess its impact on the management~     of patients with high-grade gliomas in order to provide medico-economic justification for its~     use. The article by the UCLA group showed that 18F-FDOPA modified 41% of management decisions~     for patients with brain tumors (Walter JNM 2012). However, this study comprised 58 patients,~     combined primary and recurring tumors, and was based on questionnaires sent out to referring~     physicians. A targeted study is needed, therefore, to make a prospective multicenter~     assessment of the contribution of this technique in the context of high-grade glial tumors~     and neurooncology MCCs.~   "
71454|NCT02631642|"~     The purpose of this study is to evaluate the safety and tolerability of a single dose of~     HMPL-689 in healthy volunteers To determine the pharmacokinetic profile of single oral doses~     of HMPL-689 in healthy volunteers~   "
71455|NCT02631629|"~     This project aims at proving the efficacy and safety of food based solutions to prevent~     vitamin D deficiency in high risk populations of Caucasian and South Asian origin living in~     Denmark.~   "
71456|NCT02631616|"~     Purpose: Castrate resistance prostate cancer (CRPC) often shows histological evidence of~     neuroendocrine differentiation (NED). Recently the investigators initiated a research project~     investigating the uptake of the radiotracer 68Ga-DOTATET (a marker of neuroendocrine~     tumors-NET) in PET/CT in patients with CRPC. In 4/8 patients studied thus far, uptake of the~     tracer in bone metastases was found. It has been shown that monthly injections of~     Somatostatin lengthen overall survival in patients with NET. The purpose of the current~     project is to examine the ability of Somatostatin to stabilize or possibly reverse metastases~     in patients with CRPC that express high level of somatostatin receptors in 68Ga-DOTATET~     PET/CT.~      Materials and Methods: 30 patients with CRPC will be studied with 68Ga-DOTATET PET/CT.~     Patients showing uptake of the radiotracer 68Ga-DOTATET in at two least to metastases will be~     considered eligible for the study. These patients will be evaluated biochemically and~     clinically and will be treated with monthly injections of Sandoatatin LAR - 30mg. Clinical,~     biochemical and imaging studies (68Ga-DOTATET PET/CT) will be repeated after 4 and 12 months~     of treatment. Responding patients (stabilization or decrease in the number and SUV of~     metastases) will be subjected to continued therapy until progression.~   "
71457|NCT02631603|"~     Stop exogenous allergic alveolitis (EAA) in childhood: healthy into adulthood - a randomized,~     double-blind, placebo-controlled, parallel-group study to evaluate prednisolone treatment and~     course of disease.~      The hypothesis of the study is that the treatment with placebo will not be inferior in terms~     of Forced Vital Capacity (FVC) improvement than treatment with systemic steroids after 6~     months treatment.~   "
71458|NCT02631590|"~     The purpose of this study is to see if an experimental drug, called copanlisib is effective~     and safe in treating adult participants with cholangiocarcinoma, when used in combination~     with gemcitabine and cisplatin.~   "
71459|NCT02631577|"~     This study will evaluate the safety, efficacy, pharmacokinetics and immunogenicity of~     induction treatment consisting of atezolizumab in combination with obinutuzumab plus~     lenalidomide in patients with relapsed or refractory follicular lymphoma (FL), followed by~     maintenance treatment with atezolizumab plus obinutzumab plus lenalidomide in patients who~     achieve a complete response (CR), a partial response (PR), or stable disease at end of~     induction.~   "
71460|NCT02631564|"~     The purpose of this study is to observe whether hepatic infusion by oxaliplatin, irinotecan~     and raltitrexed with or without embolization by lipiodol or microspheres are effective in the~     treatment of refratory liver metastasis from colorectal cancer.~   "
71461|NCT02631551|"~     Study to evaluate the efficacy and safety of GSP 301 NS compared to placebo NS and to~     individual monotherapies (comparators) as well as the efficacy of these monotherapies~     (comparators) versus placebo NS over 14 days of study treatment~   "
71462|NCT02631538|"~     This study is a multi-national, multi-center, double-blind (sponsor open), randomized,~     placebo-controlled trial in subjects with active primary Sjögren's syndrome designed to~     understand the safety and tolerability profile of belimumab/ rituximab co-administration and~     of belimumab monotherapy; and to evaluate whether either co-administration therapy or~     belimumab monotherapy has a substantive effect on disease activity.~      This study will consist screening period, double blind treatment period, a general follow-up~     period and individualized follow-up period. Approximately 70 subjects will be recruited into~     the study initially. At Day 0, subjects will be randomized 1:2:2:2 to one of the four~     treatment arms placebo arm, belimumab monotherapy arm, co-administration therapy arm and~     rituximab monotherapy arm. Once a sufficient number of subjects have completed the Week 24,~     interim analyses and sample size re-estimation will be conducted. The total number of~     subjects randomized may increase following sample size re-estimation up to a maximum of 120~     recruited into the study.~      Subjects in all arms will receive investigational product (IP) until Week 52 (completion of~     the treatment phase). All subjects will enter a 16-week general follow-up period after the~     Week 52 visit or after discontinuation if a subject discontinues IP and withdraws from the~     treatment phase visits prior to Week 52.~      After completing the general follow-up period, subjects with cluster of differentiation~     (CD)19+ B-cell levels below the lower limit of normal (or less than 90 percent [%] of~     baseline, if baseline value was below lower limit of normal [LLN]) will enter an~     individualized safety follow-up phase and return to the clinic for visits every 12 weeks with~     monthly calls between visits to evaluate subjects for any serious adverse events (SAEs)~     related to IP or study participation, fatal SAEs, and designated adverse event of special~     interests (AESIs) (i.e., infections, malignancies, or depression, suicide/self-injury), and~     to check concomitant medications.~      The total duration of participation of a subject in this study will be approximately up to a~     maximum of 2 years (i.e., up to Week 104).~   "
71463|NCT02631525|"~     Bispectral monitoring anesthesia with remifentanil-desflurane has a better post-operative~     recovery than remifentanil-propofol.~   "
71466|NCT02631486|"~     Shoulder pain is among the most common musculoskeletal complaints, leading to high number of~     General Practioners consultations in the United Kingdom. On the top list of the disorders~     causing pain and dysfunction of shoulder is rotator cuff tears. The aetiology of rotator cuff~     tears is multifactorial and is likely to be a combination of age-related degenerative changes~     and trauma during life. It is present in approximately 25% of individuals in their 60s and~     50% of individuals in their 80s and have been shown to start developing during the 40s. To~     recover functional status of this patients group, surgical repair is often recommended, but~     for optimal results the rehabilitation is of great importance and must be adequately planned.~     After surgery a period of movement restriction is followed, however, the optimal time of~     immobilisation is unknown. As a common practice, patients use a sling for six weeks and avoid~     any activities with the affected shoulder. This period is important to protect the tendon,~     allow good healing and to possibly prevent re-tear episodes. Although, the delayed motion may~     increase the risk of postoperative shoulder stiffness, muscle atrophy and potentially delay~     improvement of functionality. Based on the available evidence, it is difficult to make a~     clinical decision for a well-programmed rehabilitation regime and establish the most~     favourable postoperative time to start it. Moreover, it is not clear if early mobilisation~     will benefit more severe stages as published studies have methodological flaws that~     compromises the clinical decision for patients with higher commitments. The question whether~     early mobilisation application is beneficial is of high importance as the results will not~     just help improving patients quality of life, but also may reduce costs as further~     complication may be avoided.~   "
71467|NCT02631473|"~     This study is an open-label, prospective pharmacokinetic study investigating two~     antiretroviral agents in parallel and employing an adaptive design with two stages, whereby~     the results obtained in the primary stage inform the doses selected for investigation in the~     secondary stage~   "
71468|NCT02631460|"~     This study compared the efficacy and safety of S1 plus carboplatin (C) followed by S1 with~     pemetrexed plus carboplatin (C) followed by pemetrexed in patients with epidermal growth~     factor receptor (EGFR) wild type advanced nonsquamous non-small-cell lung cancer~     (NSCLC).Patients with previously untreated EGFR wild type stage IIIB or IV nonsquamous NSCLC~     and Eastern Cooperative Oncology Group performance status of 0 to 1 were randomly assigned to~     receive pemetrexed 500 mg/m2 or S1（80-120 mg/d）combined with carboplatin area under the curve~     (AUC) 5 every 3 weeks for up to four cycles. Eligible patients received maintenance until~     disease progression: pemetrexed or S1. The primary end point of this non-inferiority study~     was progression free survival（PFS）~   "
71469|NCT02631447|"~     To evaluate the best sequencing approach with the combination of target agents (LGX818 plus~     MEK162) and the combination of immunomodulatory antibodies (ipilimumab plus nivolumab) in~     patients with metastatic melanoma and BRAF V600 mutation.~   "
71470|NCT02631434|"~     Comparison between sit-to-stand test and six minutes walking test in chronic obstructive~     pulmonary disease patients~   "
71471|NCT02631421|"~     Right ventricular (RV) failure is the predominant cause of death in pulmonary arterial~     hypertension (PAH). No RV-specific therapies are available, in part because the underlying~     mechanisms of RV dysfunction are poorly understood. Given the heart's preference for fatty~     acids (FA) as an energy source, a deeper understanding of FA metabolism may shed light on RV~     adaptation to elevated afterload in PAH. The purpose of this study is to test the hypothesis~     that defects in fatty acid metabolism are common in PAH and contribute to RV failure. The~     investigators will measure peripheral and transcardiac lipid and glucose metabolites in PAH~     patients in comparison with patients with pulmonary venous hypertension and no evidence of~     pulmonary hypertension. The investigators will also correlate metabolites with concurrent~     measurement of right ventricular function.~   "
71472|NCT02631408|"~     Vancomycin powder (for solution for Infusion) will be investigated (off-label usage) in~     spinal fusion surgery. The powder will be locally administered into to the wound cavity~     before wound closure.~      Hypothesis: Locally applied vancomycin powder leads to a reduction in postoperative surgical~     site infections~   "
71473|NCT02631395|"~     Very little is known about the potential for preventing the prevalence of shoulder complaints~     in handball players, particularly younger players. The aim of this study is to evaluate the~     effect of a shoulder training program on shoulder pain during a season of team handball.~   "
71474|NCT02631382|"~     Randomized clinical trial to compare the effectiveness and safety of double (traditional)~     versus single (Asian) cupping techniques in chronic low back pain.~   "
71475|NCT02631369|"~     Pre-Study: Evaluation of the inter- and intrarater reliability of the integrated algorithm by~     Heidelberg Spectralis for measuring cyclotorsion on SLO-fundus fotographs, and assessment of~     the influence of measuring with or without eye tracker.~      Study: Comparison of cyclotorsion measurements in patients with forth nerve palsy and in~     healthy controls on SLO-fundus fotographs using the integrated algorithm by Heidelberg~     Spectralis~   "
71476|NCT02631356|"~     The study is to investigate the effect of succinylated gelatin on the blood viscosity and~     oxygen delivery in patients during surgeries, so as to have a better understanding of the~     safety in the use of succinylated gelatin for surgical patients.~   "
71477|NCT02631343|"~     While newborn and child survival remains a priority, optimal development of survivors is~     receiving increasing attention. Interventions that impact both survival and development~     should be prioritized for action. Kangaroo Mother Care (KMC) improves survival, and~     potentially neurodevelopment, in preterm and low birth weight infants in hospital settings~     but its coverage remains low. Innovation is required to allow the community-based delivery of~     KMC by front-line workers. This could greatly accelerate scale up and sustainability of this~     intervention in low resource settings.~      The proposed randomized trial is planned in a setting where 40% of births take place at home.~     Early discharge (as early as within 12 hours of birth) is common for facility births, often~     at the request of families for social and cultural reasons. Many of the hospitals do not have~     incubators for the care of very small babies.~   "
71526|NCT02630693|"~     The purpose of this study is to determine if the combination of endocrine therapy and~     Palbociclib at a daily dose of 100 mg will result in a better response to therapy with fewer~     dose interruptions than the proposed dosing regimen of 125 mg daily for 21 days out of a 28~     day cycle in combination with endocrine therapy.~   "
71478|NCT02631330|"~     Practice guidelines in caring for the geriatric population recommend performing an annual~     screening of falls . However, one of the problems that interfere with fall prevention~     programs is the lack of importance accorded to health professionals to falls. This lack of~     awareness of the risks faced by the associated geriatric population falls generates~     reluctance to adherence to a fall prevention program . At European level there are the same~     gaps in knowledge about the real effectiveness and efficiency of fall prevention programs .~      HYPOTHESIS: The implementation of a multicomponent fall prevention program in frail and~     pre-frail elderly community-dwelling people reduce the incidence of falls.~      OBJECTIVES~      General:~      • To determine the efficacy of a comprehensive program to prevent falls in the community.~      Specific:~        -  Knowing whether reducing the incidence of falls implies a reduction in visits to primary~          care, emergency department or hospital staying.~        -  Knowing the adhesion, through indirect measures, to the intervention program.~        -  Knowing the nutritional, functional, cognitive, social, anthropometric, respiratory and~          clinical profile, including falls, of the sample.~      MATERIAL AND METHODS~      Study design:~      Multicenter community intervention study, longitudinal, prospective, randomized, and~     experimental.~      Through intervention by nurses in primary care education of subjects over 70 years it is to~     know the effectiveness of a comprehensive program of falls prevention.~      It will proceed to recruit older than or equal to 70 years subjects, who meet frailty~     criteria age, belonging to the areas of Madeira Island (Portugal) and La Ribera County~     (Valéncia, Spain) .~   "
71479|NCT02631317|"~     PROMISE is a prospective, nationwide, multicenter, longitudinal cohort study, focusing on~     hospital intravenous thrombolysis process reengineering for acute ischemic stroke (AIS). With~     a proposed Reengineered Process Framework for intravenous thrombolysis process by the~     PROMISE study steering committee, about 30 medical centers enters would be recruited~     nationwide, and each center would include consecutive AIS patients with an onset-to-door time~     (ODT) of less than 3.5 h. The investigators hypothesize that the proposed Reengineered~     Process Framework is suitable and feasible for hospitals in mainland of China; the rate of~     intravenous rt-PA thrombolysis in ischemic stroke patients with an ODT of less than 3.5 h~     would be more than 20% or be increased by 40% as compared with baseline; the proportion of~     patients with a door-to-needle (DNT) time of less than 60 min would be more than 20%, or be~     with an increase by ≥ 40% as compared with baseline.~   "
71480|NCT02631304|"~     The purpose of this study is to assess the association between the point-of-care (POC)~     measured ChE activity (Acetylcholinesterase (ChE) + Buturylcholinesterase (ChE)) and~     postoperative delirium in elderly patients undergoing cardiac surgery.~      Furthermore the investigators aim to identify factors, which influence the baseline levels~     and the time course of ChE activity.~   "
71481|NCT02631291|"~     This study is for adults 60 years and older who are grieving the recent loss of a spouse or~     partner. Bereavement is one of the most distressing transitions faced by older adults and~     triggers dramatic changes to older adults' daily routine which puts them at-risk for a mood~     disorder. The purpose of this study is to promote bereaved elders' mental health by focusing~     on healthy lifestyle practices. Study treatment involves using a tablet to record their daily~     physical activity, diet, and sleep behaviors, for 12 weeks. The investigators follow-up with~     people for up to one year.~   "
71482|NCT02631278|"~     The aim of this study is to investigate the safety and feasibility of a radiofrequency (RF)~     system employing RFITT (CelonProSurge) probes for the ablative treatment of uterine fibroids.~   "
71483|NCT02631265|"~     It has been reported that insulin basal rate reduction initiated at exercise onset can reduce~     the hypoglycemic risk during exercise. However, another potentially more efficient strategy~     to prevent exercise-induced hypoglycemia could be to reduce insulin basal rate a certain time~     prior to exercise. No study investigated what would be the best timing to initiate such~     temporary basal insulin reduction. Therefore, the objective of this study will be to compare~     the efficacy of three strategies to prevent exercise-induced hypoglycemia during a 45 min~     exercise at 60% VO2peak (moderate intensity): 1) reduce insulin basal rate at the time of~     exercise; 2) reduce insulin basal rate 20 minutes prior to exercise; 3) reduce insulin basal~     rate 40 minutes prior to exercise. Investigators hypothesize that the time spent in~     hypoglycemia will be less when the insulin basal rate is reduced 40 minutes prior to exercise~     compared to a reduction at the time of exercise. Secondary hypotheses are: 1) Time spent in~     hypoglycemia will be less when the insulin basal rate is reduced 20 minutes prior to exercise~     compared to a reduction at the time of exercise; 2) Time spent in hypoglycemia will be less~     when the insulin basal rate is reduced 40 minutes prior to exercise compared to a reduction~     20 minutes prior to exercise.~   "
71484|NCT02631252|"~     This is an open label phase I clinical trial of hydroxychloroquine (HCQ) ,when it is combined~     with the usual medications for acute myeloid leukemia, mitoxantrone and etoposide. The~     purpose of this study is to find the safest and most effective dose of hydroxychloroquine~     with these medications. The investigators will be testing to see if it can increase the~     effectiveness of mitoxantrone and etoposide.~   "
71485|NCT02631239|"~     Extranodal natural killer (NK)/T-cell lymphoma (ENKTL), nasal type, is a distinct and~     heterogeneous histopathologic subtype of non-Hodgkin lymphoma (NHL), accounting for 5%~10%.~     The frequency of ENKTL among NHL patients is significantly higher in Asia than in Western~     countries, with poor prognosis. Radiotherapy plus chemotherapy has improved the survival for~     these patients. But the optimal treatment schedule is controversial. The previous protocols~     usually contained high dose methotrexate, but the application of them is limited for the~     toxicity.~   "
71486|NCT02631226|"~     The purpose of this study is to determine the prevalence and risk factors for multi-resistant~     enterobacteriaceae colonization in less than 32 weeks pregnant women admitted to the hospital~     and its transmission to the newborn, in order to avoid neonatal intensive care unit spread~     and nosocomial outbreaks.~   "
71487|NCT02631200|"~     This study will test the feasibility of carrying out a randomised controlled trial,~     incorporating a mixed methods process evaluation, to evaluate advance care planning with~     older patients who have end-stage kidney disease.~   "
71527|NCT02630680|"~     The purpose of the study is to assess Eziclen/Izinova drug utilisation in the real life~     setting in a representative sample of the European target population.~   "
71808|NCT02627027|"~     This study is a randomized, open-label, single dose, 2-way crossover study to compare the~     pharmacokinetic characteristics of CKD-395 0.25/750 mg in healthy male volunteers.~   "
71488|NCT02631187|"~     This is a study that aims to evaluate the feasibility of undertaking a United Kingdom (UK)~     multi-centre randomised controlled trial of BET for the treatment of moderate (grade 2 or 3)~     retraction pockets (RPs). This future study will aim to address the question: Does BET~     improve symptoms scores, audiometry and otoscopic appearance of Grade 2-3 pars tensa RPs in~     adult patients?~      Currently conservative treatments for this condition has been shown to be ineffective; there~     is a significant risk of progression to hearing loss or more serious complications in~     untreated retraction pockets; and the surgical treatments available to us in the UK not only~     have a number of risks and drawbacks, but also do not aim to treat the underlying cause~     (Eustachian Tube dysfunction (ETD)).~   "
71489|NCT02631174|"~     The potential role of ATIII in achieving and maintaining adequate anticoagulation in~     pediatric patients on the heart-lung machine has recently taken on increased importance as~     caregivers strive to mitigate the risk for clinically significant clotting problems. It is~     known that ATIII levels are decreased in normal neonates and infants less than 6 months of~     age relative to older children and adults and become even further decreased in critically ill~     neonates and infants, including those with congenital heart disease. The current utilization~     of ATIII in the context of support on a heart-lung machine is based on pharmacokinetic data~     derived from adult subjects with congenital ATIII deficiency. There is a gap in knowledge as~     to the appropriate frequency of ATIII repletion, best method of monitoring, and mode of~     administration in critically ill neonates and infants receiving support on a heart-lung~     machine.Our long-term goal is to determine if antithrombin (ATIII) can effectively change the~     coagulation system in patients undergoing heart-lung machine support. The objective of this~     proposal, which is our first step in pursuit of that goal, is to determine the~     pharmacokinetics of ATIII in neonates and infants. Our central hypothesis is that ATIII will~     have different pharmacokinetic properties in neonates and infants than adults and these~     properties will be affected by the use of heart-lung machine.~      This research will result in critical data on the pharmacokinetics of ATIII in neonates and~     infants receiving heart-lung machine support. This contribution is significant because it is~     the first step in a continuum of research that is expected to lead to the development of a~     therapeutic strategy employing ATIII that will facilitate improved modulation of the~     coagulation cascade to prevent significant clotting and bleeding complications in pediatric~     patients requiring heart-lung machine support.~   "
71490|NCT02631161|"~     A glass hybrid restorative system (EQUIA forte) clinically compared to a composite resin~     based material (Clearfil SE Bond, Filtek Supreme XT) for the treatment of dental non-carious~     cervical lesions.~   "
71491|NCT02631148|"~     In a 6 week pilot study, 20 individuals with habitual sleep restriction will all be asked to~     extend their nightly sleep by 1 hour, and will then be randomized 1:1 to nightly~     controlled-release oral melatonin (2mg) or placebo. The investigators will assess whether~     sleep extension and nightly melatonin supplementation in the community is a feasible~     intervention with a beneficial effect on the following chronic kidney disease (CKD) risk~     factors: systemic and renal specific renin-aldosterone-angiotensin system (RAAS) activation~     (systemic plasma renin activity, plasma angiotensin II levels, 24-hour urine aldosterone~     excretion, and renal plasma flow response to captopril); nocturnal blood pressure measured by~     24-hour ambulatory blood pressure monitor; central blood pressure measured by pulse wave~     analysis; and glucose metabolism measured by Minimal Model assessment of insulin resistance~     and β-cell response to a mixed meal protocol.~   "
71492|NCT02631135|"~     It is important to wake up without any problem and comfortably from the general anesthesia.~     The aim of this study is to investigate the effects of addition dexmedetomidine to the~     balanced intravenous anesthesia with propofol over the cognitive functions and also it is~     considered that the addition of dexmedetomidine would reduce the use of anesthetics drugs in~     TİVA. Together with this effects, it has been considered that the disorder of the cognitive~     functions in postoperative period and the need for anesthetic drugs in postoperative period~     will be less.~      After the approval of the Ethics Committee and the patients being informed and taking~     informed consent from them 15 male 25 female totally 40 patients between the age of 20-60~     years old, who had lumbar disc hernia, under general anesthesia have been taken under the~     study. The patients have been divided into two groups by closed envelope drawing method,~     randomly. All patients cognitive functions were evaluated by MMSE (Mini Mental State~     Examination) during the premedication visit. For this study group Standardized Mini Mental~     Test Examination (SMMT-E) were used, which has quite practical usage, for the untrained~     patients, and test composed of question-answer in order to calculate the remembering, caution~     and calculation structure and the scores were recorded. All patients had received the same~     anesthesia induction with propofol infusion (started at firstly 12 mg. kg-1 for the 30~     minutes, the second 30 minutes 9 mg. kg-1 and the BIS(bispectral index) values were arranged~     between 40-60 until the end of the operation), and remifentanil infusion (0.5 μg.kg-1 was~     applied as opioid and was arranged according to the tension artery and heart rate). In the~     dexmedetomidine group, dexmedetomidine infusion had started as 0.5 μg.kg-1 without making the~     loading dose and the dose change was not made. Rocuronium 0.5 mg. kg-1 iv. was applied for~     the endotracheal intubation. After the operation all patients have taken to the recovery~     room.~      Then the tests of cognitive function evaluation were repeated as postoperative 2nd hour, 24~     hours, 1 week and 1 month.~   "
71493|NCT02631122|"~     The aim of this study is to evaluate differences between ultrasound guided supraclavicular~     versus retroclavicular brachial plexus blocks: two similar brachial plexus nerve block~     techniques that differ in their needle trajectory and injection site.~   "
71494|NCT02631109|"~     This study aimed to investigate the efficacy and safety of Pegaspargase together with~     liposomal doxorubicin, etoposide and high dose methylprednisolone (L-DEP) as a salvage~     therapy for refractory Epstein Barr virus-induced hemophagocytic lymphohistiocytosis.~   "
71495|NCT02631096|"~     The study is a phase 2a, single blind, randomized, placebo controlled, study evaluating the~     safety, anti-viral activity, and pharmacokinetics (PK) following multiple doses of~     intravenous ARB-001467~   "
71496|NCT02631083|"~     The study is carried out to find out the inclusion of high and low glycaemic index foods to~     daily meals and how they impact 24 hour blood glucose fluctuations and energy regulation.~   "
71497|NCT02631070|"~     The study will be conducted in compliance with the International Council on Harmonisation~     (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good~     Clinical Practice (GCP) and applicable regulatory requirements.~      This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study to~     determine the efficacy and safety of luspatercept (ACE-536) versus placebo in subjects with~     anemia due to IPSS-R very low, low, or intermediate MDS with ring sideroblasts who require~     RBC transfusions.~   "
71498|NCT02631057|"~     The primary objective of this study is to compare the Length of Stay from treatment of oral~     anticoagulant initiation to hospital discharge of patients hospitalized and subsequently~     treated with dabigatran or warfarin for non-valvular atrial fibrillation in a real-world~     Japanese clinical practice. The secondary objective of the study is to compare LoS of~     patients hospitalized with 1) acute ischemic stroke, and 2) due to non-valvular atrial~     fibrillation. Other objectives are (1) to compare the in-hospital direct and indirect-related~     costs between dabigatran and warfarin, and (2) to compare the rates of patients directly~     discharged at home after the index hospitalization between dabigatran and warfarin.~   "
71528|NCT02630667|"~     The aim of this study is to investigate the acute effects of ingestion of carbohydrates -~     with different glycemic profiles - on cognitive function among preadolescent children (i.e.,~     9-10 years).~   "
71499|NCT02631044|"~     This open-label Phase 1 study will evaluate the safety, PK, and antitumor activity of~     modified T cells (JCAR017) administered to adult patients with relapsed or refractory B-cell~     NHL. The dose and schedule of JCAR017 will be evaluated and modified, as needed, for safety~     and antitumor activity. We will also determine how long the modified T cells stay in the~     patient's body and how well JCAR017 works in treating patients with non-Hodgkin's lymphoma~     whose disease has come back or has not responded to treatment.~   "
71500|NCT02631031|"~     The choice of drug administration time may affect the pharmacokinetics and/or drug response,~     and knowledge of any such circadian rhythm-dependent effects may help to reduce side effects~     or to enhance efficacy. This study designed to investigate the potential influence of the~     time of drug administration on the pharmacokinetics and pharmacodynamics of the valsartan in~     healthy subjects.~   "
71501|NCT02631018|"~     The purpose of this study is to compare the effect of a physical activity-enhanced behavioral~     weight loss intervention, compared to a standard behavioral weight loss intervention in~     African American women.~   "
71502|NCT02631005|"~     The purpose of this study is to evaluate the effects of Walk With Ease, a~     moderate-intensity exercise program, on pain, stiffness, and fatigue caused by lupus.~     Participants will receive a copy of the Walk With Ease workbook. The book provides guidance~     about walking safety as well as how to start, build-up, and maintain a walking program.~     Participants will complete questionnaires assessing their symptoms before and after~     completing the six-week program.~   "
71503|NCT02630992|"~     To evaluate the safety profile of amoxicillin-clavulanate potassium containing a reduced~     concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered~     at 90/3.2 mg/kg/day (formulation 1) or at 80/2.85 mg/kg/day (formulation 2) in two divided~     doses for 10 days. Investigators will focus on the proportion of subjects who develop~     protocol-defined diarrhea and proportion who develop diaper dermatitis that occasions the~     prescription of antifungal medication.~   "
71504|NCT02630979|"~     The study measures the degree of oncology physician satisfaction with the outcomes of some~     cytotoxic agents.~   "
71505|NCT02630966|"~     The purpose of this study is to evaluate perianal fistula healing at Week 30 in 2 different~     dose regimens of vedolizumab intravenous (IV) 300 milligram (mg) in participants with~     fistulizing Crohn's disease (CD).~   "
71506|NCT02630953|"~     The overall goals of this renewal are to replicate the findings of Seamos Saludables in~     Latina women, increase the effectiveness of the intervention, and measure~     intervention-related changes in clinical biomarkers. We will enhance the existing~     intervention by incorporating participant feedback (desire for greater interactivity and~     accountability), further targeting Social Cognitive Theory (SCT) constructs that were not~     influenced overall by the original intervention yet improved amongst our most successful~     participants (social support, outcome expectancies), and responding to changing trends and~     technology use in Latinos. We will conduct a clinical trial among Latina women in California~     randomized to either 1) the original Seamos Saludables tailored print only intervention or 2)~     a theory and text messaging-enhanced interactive technology based version of the Seamos~     Saludables intervention. We will also measure changes in cardiovascular and metabolic~     biomarkers (e.g., HbA1c, and LDL) to assess potential clinical impact of the intervention.~   "
71507|NCT02630940|"~     Analysis of exhaled breath condensate biomarkers and cough severity in patients with~     idiopathic pulmonary fibrosis.~   "
71508|NCT02630927|"~     The purpose of the study is to investigate a drug called AG-519, which is being developed for~     the treatment of a disease called pyruvate kinase deficiency (also known as PK deficiency)~     and other forms of anemia. This study is a 5 part study with Part 1 enrolling healthy~     volunteers into single ascending dose (SAD) groups, Part 2 enrolling healthy volunteers into~     multiple ascending dose (MAD) groups and Part 3 enrolling healthy volunteers to investigate~     how much of the study drug is taken up by the body and how food affects the uptake of a~     prototype formulation of AG-519, Part 4 enrolling healthy volunteers of Japanese origin to~     compare to the results of subjects of non-Japanese origin, and Part 5 a non-randomized,~     open-label, multiple dose study enrolling healthy volunteers to further investigate how much~     of the study drug is taken up by the body when dosed over 14 days.~   "
71509|NCT02630914|"~     The objective of the study is to investigate the feasibility of a hybrid procedure removal of~     the atrial fibrillation.~      This is a single procedure for both surgical epicardial by minimally invasive route~     (Thoracoscopy) without even flow controlled and supplemented if necessary by extra corporeal~     intracavitary route at the same time.~      This faster procedure combined with complete lesions have a higher success rate and less~     frequent re-hospitalizations of patients.~   "
71510|NCT02630901|"~     This multiple ascending dose study is to determine safety, tolerability, pharmacokinetics and~     immunogenicity of PRX003 in approximately 56 patients with Psoriasis.~   "
71511|NCT02630888|"~     The main goal of this study is evaluate the efficacy of memantine association on the~     treatment with a previous combination of two drugs, including quetiapine with lithium or~     quetiapine with aripiprazole in young patients with bipolar disorder type 1 non-responders or~     partial responders to that combination of drugs and evaluate the impact of this association~     at the cognitive functioning of the patients.~   "
71512|NCT02630875|"~     This study will evaluate A4250 (IBATinhibitor) as a treatment option in pediatric patients~     with chronic cholestasis with main emphasis on safety evaluation and on effects on pruritus~   "
71529|NCT02630654|"~     This exploratory study aims to evaluate the diagnostic, prognostic and response predictive~     value of a multi biomarker strategy in patients with Gastroenteropancreatic Neuroendocrine~     Tumors (GEP NETs) originating from the midgut or pancreas. Using a recently developed~     methodology enabling the evaluation of 92 concomitant cancer biomarkers will provide an~     interesting approach to solve this question (Lundberg et al 2011).~   "
71530|NCT02630641|"~     The general hypothesis put forward in this study is that the degree of cohesion (agreement)~     in the relationship, or dyadic adjustment affects a patient's quality of life and clinical~     course during the first few critical months following diagnosis and the introduction of~     treatment. The level of cohesion in the relationship is certainly not the only parameter~     associated with changes in the quality of life. Other factors must also be investigated such~     as level of education, circumstances surrounding the diagnosis (new diagnosis or relapse),~     management (single therapy or adjuvant therapy), the level of physical activity, the~     patient's age and the presence of functional disorders, etc.~   "
71513|NCT02630862|"~     The combination of aspirin and dipyridamole, two antiplatelet drugs, is approved in Italy for~     the secondary prevention of cerebral embolism in patients with carotid atherosclerosis.~      Besides antiplatelet activity, Dipyridamole has additional pharmacological action, including~     vasodilation and antioxidant properties.~      A role for oxidative stress has been suggested in acute cerebrovascular disease. In this~     study the investigators want to test the in vivo antioxidant activity of dipyridamole in~     patients who are candidate to take the drug under approved conditions of the Italian Drug~     Regulation Agency, i.e. secondary prevention of TIA/Stroke in patinets with carotid stenosis~     (>= 70%).~      To test the hypothesis that dipyridamole acts as antioxidant in vivo, oxysterols (products of~     cholesterol autoxidation) and vitamin E are measured in plasma before and after 6 months~     therapy after carotid endoarterectomy. Since dipyridamole is approved as combination~     preparation with aspirin, a control group of patients taking aspirin alone is enrolled.~      Outcome measures: plasma biomarkers (oxysterols and vitamin E) change at two time points:~     baseline and 6-months therapy.~   "
71514|NCT02630849|"~     Chronic post-thoracotomy pain is a significant adverse outcome of thoracic surgery.~     transcollation technology evaluated with a prospective randomized trial the effect of a~     multimodal no-compression suture technique of the intercostal space on postoperative pain~     occurrence in patients undergoing mini-thoracotomy.~      Patients undergoing a muscle-sparing lateral mini-thoracotomy for different thoracic diseases~     were randomly divided into two groups:one group received intercostal muscle flap harvesting~     and pericostal no-compression edge suture (IMF group), and the second group received a~     standard suture technique associated with an intrapleural intercostal nerve block (IINB~     group).~      The aim of the study was to demonstrate that the multimodal no-compression suture technique~     is a rapid and feasible procedure reducing early and chronic post‐thoracotomy pain intensity.~   "
71515|NCT02630836|"~     Prospective, unicenter, randomized, open-label, single-dose, two-arms blinded assessor pilot~     study. Thirty-two (32) elderly patients with hip fracture will be randomized to one of the~     two treatment-arms (Xcel-MT-osteo-beta or Standard treatment) and be followed for 12 month~     with the primary objective of safety. Secondary objectives are efficacy through axial~     tomography and xRay, clinical efficacy and quality of life questionnaire.~   "
71516|NCT02630823|"~     Due to the high expression of PD-L1 in endometrial cancers as well as in ovarian cancers~     which are molecularly similar to uterine serous cancers, using pembrolizumab should be~     beneficial in this patient population. Since the investigators are able to get a~     pre-treatment research- related endometrial biopsy as well as the surgical specimen post two~     cycles of pembrolizumab, the investigators will be able to evaluate the mechanism of action~     of this drug on the endometrial cancer tumor environment.~   "
71517|NCT02630810|"~     This study evaluates the effect of early oral hydration on bowel movement after CS, it~     includes 2 groups: study group participants receive 100 ml water after 1hr from the end of~     CS, while the others receive water after 6hrs from the end of CS.~   "
71518|NCT02630797|"~     This study uses a bone labeling calcium tracer methodology to compare the dose-response~     effect of blueberry consumption on calcium retention and bone loss. Post-menopausal women~     will receive food or beverage products containing freeze-dried blueberries in the amount~     equivalent to 0.75 (low), 1.5 (medium), and 3 cups (high) of fresh blueberries per day over a~     42-day period. The hypothesis is that the polyphenolics found in blueberries will reduce~     calcium loss from bones.~   "
71519|NCT02630784|"~     VNI Versus is a clinical, prospective, randomized, cross over study, aiming to compare two~     mechanical ventilators during non-invasive ventilation for patient suffering from respiratory~     acidosis.~      This study will compare a dedicated ventilator for Non Invasive Ventilation (NIV) functioning~     with a turbine and with vented mask (exhalation by a calibrated leak) and a dedicated~     ventilator for Intensive Care Unit (ICU), functioning with non-vented masks and an exhalation~     valve.~      Patient will be randomized before the first NIV session lasting 2 hours. After a two hours~     wash-out, a second NIV treatment will be delivered with the other ventilator for duration of~     2 hours.~      Arterial blood samples will be collected at the beginning and the end of each session of NIV.~     A transcutaneous captor of dioxide carbon pressure (PCO2) will also be used for patient~     monitoring.~   "
71520|NCT02630771|"~     This proposal will investigate pain modulatory mechanisms and brain functional and structural~     characteristics using multiple MRI modalities in persistent dentoalveolar pain disorder~     (PDAP) patients with and without temporomandibular disorders (TMD). All measures from~     patients will be compared to painfree controls.~   "
71521|NCT02630758|"~     The purpose of this study was to examine the efficacy of a 12-week mindfulness-based yoga~     intervention on depressive symptoms and rumination among depressed women.~   "
71522|NCT02630745|"~     The aim of the study is to conduct a prospective randomized clinical trial to evaluate the~     effect of immediate and delayed surgical periodontal therapy after non-surgical endodontic~     treatment on periodontal healing of the concurrent endodontic -periodontal lesion with~     communication.~   "
71523|NCT02630732|"~     The primary scientific objective of the study entails examining whether perioperative pain~     neuroscience education (PPNE or 'brain school') is more effective than classical back school~     in reducing pain and improving pain inhibition in patients undergoing surgery for spinal~     radiculopathy. A secondary objective implies examining whether PPNE is more effective than~     classical back school in imparting a behavioural change (i.e. decreasing postoperative~     healthcare expenditure for lumbar radiculopathy), improving functioning in daily life and~     improving surgical experience (=better prepared for surgery, surgery meeting their~     expectations) in patients undergoing surgery for spinal radiculopathy.~   "
71524|NCT02630719|"~     The goal of this study is to determine whether timolol eye drops are effective in alleviating~     acute migraine headaches. Subjects will be randomized to receive either timolol eye drops or~     placebo (tears) to use as a migraine abortive medication.~   "
71525|NCT02630706|"~     This is a study is to evaluate the efficacy and safety of the addition of ertugliflozin to~     metformin monotherapy in Asian participants with Type 2 diabetes mellitis (T2DM) who have~     inadequate glycemic control on metformin monotherapy. The primary hypothesis is that the mean~     reduction from baseline in hemoglobin A1C (HbA1C) for both 15 mg and 5 mg ertugliflozin is~     greater than for placebo.~   "
71531|NCT02630628|"~     Prospective, randomized, parallel-group controlled, open-label, international (Asian)~     multicenter, comparison of corticosteroids combined with TAC and corticosteroids combined~     with MMF.~   "
71534|NCT02630589|"~     Tinnitus is the perception of sound or noise in the absence of an external physical source.~     It is a highly prevalent condition and for a high percentage of patients, there is no~     satisfying treatment modality. For some people, tinnitus has a very severe impact on quality~     of life, leading to incapacity for work and sometimes even suicidality. The auditory~     brainstem implant (ABI) is an implant indicated for the restoration of hearing in patients~     with an hypo-, or aplasia of the cochlear nerve or with dysfunction of the nerve caused by~     tumor growth in neurofibromatosis type II. It has been shown that the standard intended~     effect of an ABI has reduction of tinnitus as a welcome side effect in about 66% of the~     cases. This is in analogy with the promising effect of a cochlear implant (CI) as a treatment~     for patients with unilateral tinnitus. In this study, the effect of an ABI on severely~     invalidating, unilateral, intractable tinnitus will be investigated. The ABI may have an~     advantage over the CI as tinnitus treatment, because CI-implantation leads to destruction of~     inner ear structures, leading to profound deafness, while an ABI is presumed to not damage~     anatomical structures. This is the first study to implant an ABI for the primary aim of~     tinnitus reduction in an intervention pilot study. In total 10 patients with unilateral,~     intractable tinnitus and severe hearing loss in the ipsilateral ear, will be implanted with~     the ABI.~   "
71535|NCT02630576|"~     TetraGraph is a newly developed EMG-based (electromyograph), quantitative, battery-powered~     neuromuscular monitoring system intended for daily clinical use. The primary aim of this~     clinical investigation is to examine the applicability (ease of use, equipment need, etc.),~     repeatability (precision or internal consistency) and performance (signal quality, accuracy~     of outcome, voltage of stimulation output before and during a stimulus) and tolerability of~     the Tetragraph device in healthy volunteers.~   "
71536|NCT02630563|"~     The study is planned to be conducted in 2 parts. The first part (open label, multi-center,~     non-controlled) of the study will estimate a dose that would provide a mycophenolic acid~     (MPA) exposure in pediatric participant that is comparable to that achieved in adult liver~     transplant participants receiving the approved dose of mycophenolate mofetil (MMF, CellCept).~     The second part (open-label, multi-center, single-arm Phase IV study) of the study will~     provide the pharmacokinetics, efficacy and safety profile of the proposed dose in the~     immediate post-transplant period. This study will be conducted at two centers based in the~     United States of America. Twelve pediatric transplant participants receiving a first liver~     allograft from a cadaveric or living donor will be enrolled in this study. Stable pediatric~     liver transplant participants who are at least 6 months post-transplant and who were already~     receiving stable dose of MMF in combination with cyclosporine will be enrolled into the~     study. Participants should have received stable MMF dose according to center practice for at~     least seven days in order to get steady state pharmacokinetics (PK). Participants also should~     have received stable concomitant doses of cyclosporine (for at least 2 days) and~     corticosteroids per center practice. Participants will be aged between 9 months and 12 years,~     with at least 6 participants greater than or equal to (>/=) 9 months and less than (<) 36~     months, of whom at least 2 will be <24 months.~   "
71537|NCT02630550|"~     The Cheetah NICOM is a non-invasive cardiac output monitor that has been validated in various~     clinical contexts but not during the occlusion of major arteries, as takes place in vascular~     surgery. The present study will evaluate the precision and validity of the measures taken by~     the device during open vascular surgery procedures. The measurements will be compared to the~     those calculated by transesophageal echocardiography at various key points during the~     surgeries. The validity of the cardiac output, stroke volume and stroke volume variation~     measurements will be evaluated, as well as the device's ability to track rapid changes in~     cardiac output.~   "
71538|NCT02630537|"~     Cell-mediated immunity (CMI) and in particular T cells play a critical role in the rejection~     of transplanted organs. Thus, in transplant recipients a life-long and individualized~     immunosuppressive medication is required to avoid graft rejection. However, a too weak~     suppression of CMI causes acute and chronic graft damage leading to transplant loss, whereas~     a too potent suppression of CMI supports opportunistic infections and reactivation of~     persistent viruses.~      One of the biggest challenges in the field of transplantation is to provide a personalized~     immunosuppressive and antiviral therapy based on reliable assessment and monitoring of CMI.~     This could lead to a reduction of graft rejections and virus reactivations in transplant~     recipients.~      With the development of both assays T-Track® CMV and T-Track® EBV, Lophius Biosciences GmbH~     has implemented its novel proprietary T-activation technology for an improved assessment of~     the functionality of CMI in cytomegalovirus (CMV)- and/or Epstein-Barr virus~     (EBV)-seropositive individuals. In contrast to other existing systems the Lophius assays open~     up the opportunity to characterize the functionality of CMI as an entire network.~      The planned clinical multicenter study aims to verify the suitability of the two assays for a~     reliable assessment of the functionality of CMI.~      Hemodialysis patients have been identified as an appropriate patient cohort for investigating~     the clinical sensitivity of the Lophius assays as these patients closely resemble kidney~     transplant recipients prior to an immunosuppressive therapy.~      The determination of the functional CMI in the course of an immunosuppressive treatment may~     in future enable physicians to optimize the individual immunosuppressive and antiviral~     therapy in transplant recipients to reduce the risk of rejection as well as virus~     reactivations and associated diseases.~   "
71539|NCT02630524|"~     The purpose of this study is to examine the effectiveness of a low carbohydrate diet on~     increasing dietary adherence and improving cardiometabolic risk factors among adults with~     spinal cord injury (SCI). Seventy overweight/obese adults with SCI will be randomized to one~     of two groups: 1) a reduced carbohydrate diet or 2): a standard diet (STD). Participants~     will take part in a 6-month behavioral lifestyle intervention implemented through a novel~     eHealth platform specially designed for individuals with SCI.~   "
71540|NCT02630511|"~     Although asthma is a disease of the airways, research is now showing that asthmatics are more~     likely to develop cardiovascular disease (CVD) compared to non-asthmatics. Vascular~     dysfunction is seen in people at high risk of CVD and has been linked to inflammation. During~     an asthma attack, levels of inflammation in the whole body increase, which could potentially~     explain why asthmatics are at increased risk of CVD. By exercising, people can change the~     amount of inflammation in their bodies, improve vascular function, and thereby reduce the~     risk of CVD. In the proposed study the investigators will assess if asthma attacks lead to~     increased risk of CVD by evaluating inflammatory levels and vascular function before and~     after asthma attacks. The investigators will also evaluate if exercise reduces the~     cardiovascular risk following asthma attacks. The results from this study will help in~     understanding why asthmatics are at increased risk of CVD.~   "
71809|NCT02627014|"~     The aim of this study is to determine whether treatment of temporomandibular joint is more~     effective than usual care in patients with chronic migraine and temporomandibular disorders~     to reduce pain.~   "
71541|NCT02630498|"~     This is a non-randomized prospective study. Patients undergoing upper extremity and shoulder~     surgical procedures after trauma at SJHC and LHSC will be divided in to two groups. The first~     group will include those who receive a single shot brachial plexus (interscalene,~     supraclavicular, infraclavicular and axillary) block with or without general anesthesia. The~     second group will be the control group and include those patients who receive general~     anesthesia only, without any block whether due to the preference of patient or the surgeon~   "
71542|NCT02630485|"~     The purpose of this study is to help women with PCOS to improve their symptoms and ovulation~     rate through a lifestyle intervention program which introduces a specific diet, a physical~     activity regimen and mindfulness exercises to improve psychological well-being and overall~     health.~   "
71543|NCT02630472|"~     The purpose of the study is to evaluate the physiologic response of quinine-saline~     irrigations for acute exacerbation of uncomplicated chronic rhinosinusitis following~     endoscopic sinus surgery. Subjects who have previously had functional endoscopic sinus~     surgery with acute exacerbation of chronic rhinosinusitis will be randomized to either a~     quinine-saline or saline-placebo arm. The investigators will measure baseline and follow-up~     clinical and quality-of-life outcomes for both arms, and then compare the groups at the end~     of the study period. The investigators' hypothesis is that the participants in the quinine~     sulfate arm will perform better on all measures as compared to the control arm.~   "
71544|NCT02630459|"~     Randomized, double-blind, placebo-controlled, parallel-group, multicenter study followed by~     an open-label treatment phase. To evaluate the effect of AMG 334 compared to placebo on the~     change from baseline in monthly migraine days.~   "
71545|NCT02630446|"~     The general objective of this quasi-experimental study is to assess the effectiveness of an~     in-home respite care program compared to a control group not receiving the same type of~     in-home respite on the well-being of the caregiver, the care-recipient and on the healthcare~     system. The latter in terms of resource use, intention to institutionalize the care-recipient~     and time to nursing home placement.~      A quasi-experimental study will be designed. The intervention group will consist of~     caregiver/care-recipient dyads receiving an in-home respite program called Baluchonnage and~     will be compared to a control group that doesn't receive Baluchonnage. Comparison between~     the groups will be done by collecting health related and economic data. The trial will~     evaluate outcomes as well in the caregiver as in the care recipient (measured via the~     caregiver). The primary research outcome is caregiver burden. Secondary outcomes for~     caregivers are: health related quality of life and reactions to behavioral problems of the~     care-recipient. A secondary outcome related to the care-recipient is: frequency of behavioral~     problems. Secondary outcomes for the healthcare system are: intention to institutionalize the~     recipient into a nursing home and resource use of the recipient. Finally, in a follow up~     phase of the trial possible differences in time to nursing home placement will be measured~     (as well as burden and intention to institutionalize. Additionally, willingness to pay for~     Baluchonnage per day will be asked to the informal caregivers. Eventually, if the~     intervention is effective, modeled and trial based cost-effectiveness analyses will be~     undertaken in a separate economic evaluation plan.~   "
71546|NCT02630433|"~     There are controversies optimal timing for cholecystectomy in patients with mild biliary~     pancreatitis. The safety of cholecystectomy performed during an episode of pancreatitis has~     been questioned. The aim of the present randomized controlled trial is to compare the outcome~     in terms of recurrent pancreatitis and gallstone-related events between index~     cholecystectomy, performed during the first admission for acute pancreatitis, and scheduled~     cholecystectomy, performed 4-6 weeks after discharge.~   "
71547|NCT02630420|"~     Two-part phase 1B clinical trial combining cextuximab and savolitinib for treating Ras~     wild-type colorectal cancer (CRC). Part 1 will assess the safety and tolerability of this~     drug combination and will include patients with squamous cell carcinoma of the head and neck~     cancer, as well as patients with CRC. Part 2 of the study, the focus of this registration,~     will obtain further safety data for the combination of cextuximab and savolitinib and will~     look at the efficacy of cextuximab and savolitinib in Ras wild-type mCRC that was previously~     treated and relapsed on cetuximab or panitumumab.Correlative studies will examine tumor and~     blood specimens for mechanisms of anti-EGFR resistance and response to MET inhibition.~   "
71548|NCT02630407|"~     The possibility of using an intra-articular agent such as hyaluronic acid (HA) to reduce the~     post-operative inflammatory stress on the knee joint, limiting the use of other pain-killers~     and promoting a faster recovery after ACL reconstruction, seems attractive.~      The aim of the present double blind, placebo controlled study is to evaluate the effects,~     both in terms of pain control and functional recovery, provided by a single HA injection~     performed in the early postoperative phase after ACL reconstruction.~      The day after the ACL reconstruction (which is performed with the same technique for all the~     patients enrolled), the patients were randomized to receive a single injection of HA or 3 ml~     of saline solution. The randomization list was kept in a dedicated office and the injecting~     physician contacted it to know the treatment allocation just before the injection, that was~     performed by a lateral parapatellar approach, after removing the drainages and after~     attempting aspiration to evacuate any eventual residual blood from the joint. In order to~     maintain the patient blind to the treatment, a surgical drape was placed to prevent him to~     see the injective procedure.~      All patients will be evaluated at 15, 30, 60, 180 and 360 days after surgery by using the~     following tools: SF-36, IKDC subjective, VAS for pain, EQ-VAS for general Health Status and~     Tegner score. Also the trans-patellar circumference and active and passive ROM of both knees~     were registered at each follow-up evaluation.~   "
71576|NCT02630043|"~     The purpose of this research study is to evaluate an investigational drug (Tolcapone) alone~     and in combination with oxaliplatin, for relapsed and refractory neuroblastoma. Tolcapone is~     approved by the U.S. Food and Drug Administration (FDA) for adults, but is an investigational~     drug in this study because it has not been approved in pediatrics for this indication.~     Oxaliplatin, although a drug approved by the FDA for other cancers, is investigational for~     treatment of neuroblastoma in this study. This study will look at the safety and tolerability~     of tolcapone in combination with oxaliplatin as well as the tumors response to this study~     drug.~   "
71810|NCT02627001|"~     This study comprised a randomized cross-over trial of ventilation using the NuMask Intraoral~     Mask versus conventional Bag Valve Mask in a cadaver model among United States Army combat~     medics.~   "
71549|NCT02630394|"~     Acute chest syndrome (ACS), a lung complication in sickle cell disease (SCD), is the second~     most common cause of hospitalization and leading cause of death in SCD. ACS is associated~     with airway inflammation, and a major cause is pulmonary infection from atypical organisms.~     To date, there are no drugs available to reduce inflammation and risk of recurrent ACS.~     Macrolides are a group of antibiotics that exert immunomodulatory and anti-inflammatory~     actions both in vitro and in vivo. In addition, macrolides reduce bacterial burden in the~     airway of atypical organisms, all of which play an important role in the pathophysiology of~     ACS. Numerous studies have evaluated macrolide prophylaxis in conditions associated with lung~     inflammation, such as cystic fibrosis, asthma, bronchiectasis etc., and high quality evidence~     have found macrolides to be beneficial as a disease modifying agent that leads to improvement~     in airway inflammation, reduced pulmonary exacerbations and improved lung function. The~     investigators hypothesize that azithromycin prophylaxis is well tolerated and has the~     potential to reduce inflammation and improve lung outcome in children with SCD with a history~     of ACS. A prospective, single arm, open label feasibility study of azithromycin prophylaxis~     will be performed in children with SCD with a history ACS with the specific aim to examine~     the feasibility, safety and tolerability of azithromycin prophylaxis administration in~     participants with SCD , and to examine whether azithromycin prophylaxis has the potential to~     improve lung outcome. In addition, this study will determine whether azithromycin prophylaxis~     reduces inflammation in participants with SCD with a history of ACS.~   "
71550|NCT02630381|"~     Rationale: Osteoporotic fractures are associated with high morbidity and mortality. This is~     why prevention of these fractures is important. The investigators have shown in animal~     studies that a single treatment with unfocused extracorporeal shock wave therapy leads to~     highly increased bone mass and improved biomechanical properties. Unfocused extracorporeal~     shock wave therapy could have important implications for the prevention of osteoporotic~     fractures.~      Objective: To assess the effect of unfocused extracorporeal shock wave therapy on bone mass.~      Study design: A clinical pilot study. Study population: Twelve female patients are eligible~     if they are undergoing elective surgery of the lower extremity or elective spinal surgery~     under general anesthesia in the investigators hospital.~      Intervention: When the patient is under general anaesthesia he/she will receive 3000~     unfocused extracorporeal shock waves (energy flux density 0.3mJ/mm2) to one distal forearm.~     The contra lateral forearm will not be treated and serves as a control.~      Main study parameters/endpoints:~      The investigators will examine the effect on bone mass with the use of repeated dual energy~     X-ray absorptiometry measurements. These results are necessary to calculate the number of~     patients that are needed for larger studies. Furthermore, the investigators will assess~     patient's discomfort.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: General anaesthesia is performed during treatment and pain after the procedure~     will be evaluated using pain scales and, if necessary pain medication will be prescribed by~     the orthopaedic surgeon. The dual energy X-ray absorptiometry-scans and X-rays will cause~     very low radiation exposure to the patient.~   "
71551|NCT02630368|"~     Assessment of the efficacy and safety of JX-594 and metronomic cyclophosphamide in patients~     with advanced soft-tissue sarcoma and advanced breast cancer, once the Maximum Tolerated Dose~     have been determined (phase I trial).~      Phase I study: this is a prospective open-labeled phase I trial based on a dose escalating~     study design assessing two dose levels of JX594 when prescribed in combination with~     metronomic cyclophosphamide.~      Phase II study sarcoma: this is a monocentric, randomized two-arm non comparative phase 2~     study assessing efficacy and safety of JX-594 in association with metronomic cyclophosphamide~     in patients with advanced soft-tissue sarcoma.~      Phase II study breast cancer: this is a monocentric, single-arm phase II study, assessing~     efficacy and safety of JX-594 in association with metronomic cyclophosphamide in patients~     with advanced breast cancer.~   "
71552|NCT02630355|"~     This study evaluates the use of remote ischaemic preconditioning for the prevention of~     dialysis induced cardiac injury. The study uses four arms to test different frequencies of~     application to ascertain which, if any, is most successful at reducing dialysis induced~     cardiac injury.~   "
71553|NCT02630342|"~     Diagnostic Magnetic Resonance (MR) imaging procedures can be stressful for children and~     parents. Patients must lie still during the procedure to provide diagnostic quality images.~     Children <7 years are often sedated or given general anesthesia (GA) for imaging procedures.~     The high cost of GA and its associated risks motivate the search for alternatives. The~     overall goal of this study is to systematically investigate whether training on the mock MR~     scanner reduces the need for GA during Magnetic Resonance Imaging (MRI) scans in children.~      160 participants scheduled for diagnostic MRI scans at Alberta Children's Hospital (ACH) will~     be recruited to undergo different training methods for MRI scanning. Group 1 will be sent~     links to online videos about MRI, audio files with scanner noises, and a children's book~     about MR scans, to prepare at home. Group 2 will receive training materials and visit the ACH~     to review them with the research team, but will not use the mock scanner. Group 3 will~     receive training materials and visit the ACH for training on the mock MR scanner. Visits to~     the mock scanner for Group 3 will include practice lying down, staying still, wearing~     headphones, and watching a movie on the mirror system. During and after training sessions,~     the investigators will collect data on total time spent preparing (mock scanner or other),~     the child's feelings of stress/worry before and after visit, and head motion during mock MRI~     session (if applicable).~      Subjects will be scheduled for a clinical scan without GA and a follow-up clinical scan with~     GA (to be cancelled if the first scan is successful). Scan success will be determined by a~     radiologist. Measures of scan success, quality ratings for each scan, children's feelings of~     stress/worry related to the MRI, and saliva samples to measure cortisol and salivary alpha~     amylase, will be gathered at the clinical scan. An ANOVA will be used to compare different~     training groups.~      A clinical group of 35 neuro-oncology patients aged 3-7 years of age that undergo frequent~     MRI scans will also undergo staged preparation by child life specialists using the mock~     scanner. The age at which they are able to complete MRI without general anesthesia will be~     compared with a retrospective control group in the 3 years prior. Measures to be used for~     this group are the same (with the exception of saliva samples). T test and Kaplan- Meier~     analysis will be used to compare age at which MRI can be performed awake.~   "
71577|NCT02630030|"~     This phase 0 trial studies ixazomib citrate in treating patients with glioblastoma that has~     spread or returned after period of improvement who are planning to undergo surgery. When~     given by mouth, ixazomib may be able to reach tumor cells in the brain. Studying samples of~     tissue, blood, and plasma in the laboratory from patients receiving ixazomib may help doctors~     learn more about the effects of ixazomib on the cells. It may also help doctors understand~     how well patients will respond to treatment.~   "
71578|NCT02630017|"~     To investigate the effects of methylphenidate on motivated behavior in adults with and~     without ADHD~   "
71811|NCT02626988|"~     What is the role of Agricultural biodiversity in improving diet diversity, quality and~     nutrition?~   "
71812|NCT02626975|"~     MRI study of ballooning and ligamentisation short transplants of anterior cruciate ligament~     (ACL) according to DT4 technique in 60 patients with more than one year of follow up.~   "
71554|NCT02630329|"~     Objective: To compare vNOTES (vaginal Natural Orifice Transluminal Endoscopic Surgery) and~     established laparoscopic removal of benign adnexal masses Study design: Randomized~     controlled/single center/single-blinded/parallel-group/non-inferiority/efficacy trial.~      Study population: Women aged 18 to 70 years with symptomatic or persistent benign adnexal~     masses detected by clinical examination and ultrasound.~      Randomization: Women will be randomly allocated to undergo one of two techniques for removal~     of the benign adnexal mass immediately before surgery by using a computer generated~     randomization list. The investigators will use stratified randomization according to the cyst~     diameter.~      Intervention: Women will be treated by a surgeon who is not blinded to the treatment~     allocation and who is equally skilled in performing both techniques. In the intervention~     group a vNOTES technique will be used.~      Control: In the control group surgery will be done by a classical laparoscopic technique.~      Participants, nursing staff and outcome assessors will be blinded.~      Main study parameters/endpoints:~      Primary outcomes: successful removal of a benign adnexal mass without spill. Secondary~     outcomes: the proportion of women discharged the same day based on their own preference;~     postoperative pain scores using a VAS (Visual Analogue Scale) measured between day 1 till 7~     by the participating women following surgery and the total amount of analgesics used as~     described in the standardized pain treatment protocol between day 1 till 7; postoperative~     infection defined by lower abdominal pain with fever > 38°C and positive clinical signs or~     laboratory findings; per- or postoperative complications according to the Clavien- Dindo~     classification detected during the first six weeks of surgery; duration of the surgical~     procedure; incidence and intensity of dyspareunia recorded by the participants at 3 and 6~     months by self-reporting using a simple questionnaire and VAS scale; sexual wellbeing~     recorded by the participants at 3 and 6 months by SSFS (Short Sexual Functioning Scale);~     direct costs associated up to 6 weeks after the surgical intervention with both procedures.~   "
71555|NCT02630316|"~     This is a multicenter, randomized (1:1 inhaled treprostinil: placebo), double-blinded,~     placebo-controlled trial to evaluate the safety and efficacy of inhaled treprostinil in~     subjects with pre-capillary pulmonary hypertension (PH) associated with interstitial lung~     disease (ILD) including combined pulmonary fibrosis and emphysema (CPFE). The study will~     include about 314 patients at approximately 120 clinical trial centers. The treatment phase~     of the study will last approximately 16 weeks. Patients who complete all required assessments~     will also be eligible to enter an open-label, extension study (RIN-PH-202).~   "
71556|NCT02630303|"~     The goal of this study is to establish the safety of high fluence LED-RL from 160 J/cm2 up to~     640 J/cm2 in healthy subjects. The hypothesis is that high fluence LED-RL phototherapy is~     safe in human skin.~   "
71557|NCT02630290|"~     Dexmedetomidine, an alpha 2-adrenoreceptor agonist, has been found to exerts an excellent~     influences on the filed of perineural block. It could shorten the onset time and prolong the~     duration of the nerve block and improved postoperative pain. However, Dexmedetomidine-induced~     bradycardia or hypotension has recently attracted considerable attention because of~     potentially grave consequences, including sinus arrest and refractory cardiogenic shock. A~     low dose may help minimize cardiovascular risks associated with dexmedetomidine. However, few~     studies have addressed the clinical effects of low-dose dexmedetomidine as an perineural~     adjuvant. The present study was designed to test the hypothesis that low-dose dexmedetomidine~     added to ropivacaine would safely enhance the duration of analgesia without adverse effects~     when compared with ropivacaine alone. Investigators will conduct a single-center,~     prospective, randomized, triple-blind, controlled trial in patients undergoing elective~     forearm and hand surgery under ultrasound-guided supraclavicular brachial plexus block using~     either ropivacaine or ropivacaine plus low-dose dexmedetomidine. The primary outcome is~     self-reported duration of analgesia . Secondary outcomes include onset time and duration of~     motor and sensory block, total postoperative analgesics, and safety assessment (adverse~     effects and postoperative abnormal sensation).~   "
71558|NCT02630277|"~     To assess the safety and efficacy of intravitreal aflibercept injection in the regression of~     retinal neovascularization secondary to high-risk PDR.~      To characterize baseline/post-induction/maintenance levels of proinflammatory mediators in~     patients with high-risk PDR~   "
71559|NCT02630264|"~     Recombinant human endostatin adenovirus injection is a novel anti-tumor gene therapy drug.~     E10A contains a recombinant human endostatin gene with the second-generation recombinant~     adenovirus as its vector. After transfection tumor cells. E10A expresses human endostatin,~     which inhibits vascular endothelial cell proliferation and tumor angiogenesis, and blocks~     tumor blood supply, thereby specifically inhibiting tumor growth and inducing apoposis of~     tumor cells. Both pre-clinical and animal models have demonstrated the anti-tumor activities~     of E10A. The safety and efficacy of E10A in treating head and neck cancer has also been~     demonstrated in Phase I and Phase II studies.~   "
71560|NCT02630251|"~     The study drug, GSK2820151, is a Bromodomain (BRD) and Extra-Terminal (BET) inhibitor arising~     from a distinct structural class. GSK2820151 potently inhibits tumor growth in vitro and in~     vivo in animal models. This first time in human (FTIH), open-label, dose escalation study is~     to assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical~     activity of GSK2820151 in subjects with advanced or recurrent solid tumors. The objective is~     to determine the safety, tolerability and maximum tolerated dose (MTD) of GSK2820151 in~     subjects 18 years or older with advanced or recurrent solid tumors. Eligible subjects with~     advanced or recurrent solid tumors will be enrolled in the dosing cohorts until MTD is~     established. All subjects will receive study drug. Subjects may continue treatment in the~     study until disease progression, unacceptable toxicity, or withdrawal of consent. The~     duration of study will depend on recruitment rates and the timing of subjects' duration on~     study (withdrawal rates due to toxicity or progression). It is anticipated that approximately~     30 to 50 subjects will be enrolled.~   "
71561|NCT02630238|"~     This double blind placebo study will take place over an 8 week treatment period of diet and~     exercise. All participants (n=16), in two groups, will be placed on the same hypocaloric diet~     and exercise program. Participants will be matched into pairs based on body fat % and then~     assigned into a test group & a placebo group. The placebo will be in the form of a powdered~     isoenergetic beverage with carbohydrate similar in taste & appearance to the powder BCAA~     supplement that the test group will receive. The test group will be put on 0.342g/kg of BCAA~     per day, partially accounted for through their diet with the rest provided by a BCAA~     supplement. At baseline, 4 weeks and 8 weeks habitual 3 day food logs, waist to hip ratio and~     BodPod measures of body fat & lean mass (both percentage & absolute values) will be taken for~     all participants.~   "
71579|NCT02630004|"~     The main purpose of this study is to assess the efficacy of melatonin oral gel compared to~     placebo in the prevention and treatment of oral mucositis in patients with head and neck~     cancer undergoing concurrent chemoradiation.~      Other objectives are to assess the Quality of Life (QoL), to evaluate the safety and~     tolerability and to assess the pharmacokinetic profile of melatonin oral gel administration,~     in all cases compared to placebo in patients with head and neck cancer and oral mucositis~     secondary to concurrent chemoradiation.~   "
71562|NCT02630225|"~     The investigators will conduct a cluster randomized trial of an intervention program that~     combines a hospital-based intervention, structured outreach program, and multi-agency~     attention. The goal of the study is to test the effect of this multi-component intervention~     on criminal activity, injury, substance abuse, mental health, quality of life, violent~     behavior, and death.~      Investigators aim to enroll a total of 300 patients admitted to the Harborview Medical Center~     (HMC) for firearm-related injuries. Patients will be randomized to receive a multi-component~     intervention or treatment as usual. All participants will complete surveys at the time of~     study consent (baseline) and then at designated time points for 12 months post-consent. Study~     staff will routinely collect participant records from Washington State Patrol records, HMC~     medical records, Washington State trauma registry, Washington State Emergency Department~     Information Exchange, Administrative Office of the Courts, and vital records. The~     investigators will test the impact of the intervention against standard care. The hypothesis~     is that participants in the intervention group will see greater improvements in~     aforementioned outcomes than those in the control group.~   "
71563|NCT02630212|"~     The purpose of this study is to evaluate the impact of ALDH2 Glu504Lys polymorphism on aortic~     dissection.~   "
71564|NCT02630199|"~     This study is a single center open label phase I study of AZD6738, DNA damage repair/novel~     cancer agent, in combination with paclitaxel in metastatic cancer patients who have failed~     standard chemotherapy.~      AZD6738 is an orally dosed selective and potent inhibitor of Ataxia Telangiectasis and Rad3~     Related (ATR) kinase with good selectivity against other Pi3 kinase family members.~      ATR is a serine/threonine protein kinase and member of the phosphatidylinositol 3-kinase~     related kinase (PIKK) family. During normal replication, ATR is recruited at stalled~     replication forks which can progress to double strand breaks if left unrepaired. ATR is also~     recruited to single strand DNA coated with Replication Protein A (RPA) following single~     strand DNA damage or the resection of double strand breaks. Recruitment and activation of ATR~     leads to cell cycle arrest in the S phase while the DNA is repaired and the stalled~     replication fork resolved, or nuclear fragmentation and entry into programmed cell death~     (apoptosis).~      In the clinic ATR inhibitors are expected to cause growth inhibition in tumour cells~     dependent upon ATR for DNA repair e.g. ATM-deficient tumours. In addition to monotherapy~     activity, ATR inhibitors are also predicted to potentiate the activity of cytotoxic DNA~     damaging agents and radiotherapy (through inhibition of ATR-dependent DNA repair processes)~     when used in combination. While significant enhancement of anti-tumour activity may be~     achieved, data with AZD6738 suggest the potential need to reduce the ATR inhibitor dose and~     intensity (relative to monotherapy dose) and introduce dosing breaks to allow normal tissue~     recovery when used in combination with systemic DNA damaging chemotherapy agents, in order to~     maintain tolerable therapeutic margins.~      The mechanism of action of AZD6738 suggests the potential to combine it with a number of~     anti-cancer treatments, resulting in either synergistic or additive activity. This study is~     evaluating the safety, tolerability, pharmacokinetics and anti-tumour activity of AZD6738 at~     increasing doses, in combination with paclitaxel as one of standard salvage regimen in~     patients with advanced cancer.~      The study will consist of two parts, each evaluating the safety and tolerability of a~     specific combination agent, paclitaxel with different drug schedules. An oral formulation of~     AZD6738 will be used.~      The PART A will be in combination with paclitaxel; the starting dose of 40 mg AZD6738 OD will~     be escalated to reach a maximum tolerated dose in patients with advanced solid malignancies,~     as defined by dose-limiting toxicity. The PART B will be an independent parallel PK expansion~     cohort with cycle 0 of AZD6738 on D1, D8~D21 monotherapy followed by combination therapy with~     weekly paclitaxel from cycle 1. Investigators will modify to recruit the minimum or maximum~     number of patients depending on data generated from other studies using AZD6738.~   "
71565|NCT02630186|"~     This clinical research study is being carried out in two parts, Phase 1 and Phase 2. The~     primary purpose of the Phase 1 portion of the study is to observe the safety of the~     combination of rociletinib and MPDL3280A in EGFR-mutant NSCLC patients.~      The primary purpose of the Phase 2 portion of the study is to evaluate the safety and~     anti-tumor effects of the combination of rociletinib and MPDL3280A, at the best doses for the~     combination determined in Phase 1, in patients with EGFR-mutant NSCLC.~   "
71566|NCT02630173|"~     Introduction:~      To evaluate the effect of untreated endodontic infection on periodontal status in untreated~     non vital teeth with periapical radiolucency as compared to contralateral vital teeth. And~     also to evaluate the role of endodontic treatment on periodontal healing in successfully~     endodontically treated teeth with contralateral vital teeth.~      Methods:~      This study was performed in two parts. First part of this study was an observational cross~     sectional survey and second part was a clinical trial on patients selected from the survey.~   "
71567|NCT02630160|"~     A randomized double-blind clinical trial was performed. There were 4 groups according to~     catheter placement and infusion constituents: 1) Intraarticular catheter + anesthetics; 2)~     Intraarticular catheter +placebo; 3) Subfascial catheter + anesthetics; 4) Subfascial~     catheter + placebo. The anesthetics infusion contained bupivacaine (bolus + continuous~     perfusion up to 36 hours). The placebo solution consisted in physiological serum (bolus +~     continuous perfusion up to 36 hours). Randomization was performed in the hospital pharmacy~     and the surgeon kept out the surgical field when the resident placed the catheter. The same~     conventional analgesic schedule was prescribed to all patients: PCA (patient controlled~     analgesia) + paracetamol 1g/6h + dexketoprofen 50mg/12h. The pain was evaluated by means of~     PCA (patient controlled analgesia) shots and the VAS (visual analog scale). Side effects,~     time to start rehabilitation and time to discharge were also analyzed. A statistical analysis~     was performed to compare all this variables between the 4 groups (SPSS 18.0).~   "
71568|NCT02630147|"~     The purpose of this study is to evaluate the effect of vanilla odor on hypoxic intermittent~     events in premature infants born between 32.0 and 33.6 weeks of gestational age.~   "
71569|NCT02630134|"~     Study patients are given a hand held device to track pain post surgery.~   "
71570|NCT02630121|"~     The addition of intranasal oxymetazoline for two weeks to already instituted optimal doses of~     intranasal fluticasone propionate will decrease the total number of obstructive apneas and~     hypopneas per hour of sleep in subjects with perennial allergic or non-allergic rhinitis and~     mild obstructive sleep apnea who have persistent nasal congestion despite maximum doses of~     NGCS.~   "
71571|NCT02630108|"~     It is a prospective and multi-center clinical research in China to compare the efficacy,~     safety and related impact factors between TACE alone and TACE combined with synchronous~     multi-point MWA/RFA for large and huge liver cancer.~   "
71572|NCT02630095|"~     The purpose of this study is to determine the effect and safety of anticoagulation after~     endoscopic therapy in cirrhotic patients with portal vein thrombosis and to explore its~     effect on long-term rebleeding rate and mortality.~   "
71573|NCT02630082|"~     Rectal and genital sampling in HIV prevention trials permits assessments at the site of HIV~     entry. Yet the safety and acceptability of circumcision and sigmoidoscopy (and associated~     abstinence recommendations) are unknown in uncircumcised men who have sex with men (MSM) at~     high risk of HIV infection. The purpose of this study is to evaluate the feasibility of~     methods for assessing baseline characteristics of the mucosa of MSM at risk of HIV infection~     in Lima, Peru.~   "
71574|NCT02630069|"~     This study is a 12-week, randomized, double-blind, placebo-controlled trial of~     cytidine-5'-diphosphate choline in amphetamine-type stimulants-using adolescents.~   "
71580|NCT02629991|"~     The investigators propose a randomized double blind 8 week treatment trial of intranasal OXT~     vs. placebo in 24 subjects aged 5 to 18 years with PWS in order to assess IN-OXT's affect (1)~     Eating behaviors (2) Repetitive and disruptive behaviors (3) social cognition measures and~     (4) Salivary OXT levels and plasma levels of ghrelin, pancreatic polypeptide and leptin. The~     investigators will determine if IN-OXT reduces eating behaviors in addition to improving~     social cognition and reducing repetitive/disruptive behaviors in children with PWS. If~     superior to placebo, this data will add to the current knowledge that OXT is an effective~     treatment for hyperphagia as well as other problematic symptomatology of PWS.~   "
71581|NCT02629978|"~     The objective of this study is to evaluate the outcomes of radiofrequency ablation in the~     treatment of patients with malignant pulmonary nodules（not exceed 3cm ）who are not suitable~     candidates for or refuse surgical resection.~   "
71582|NCT02629965|"~     This is a multi-centre, randomised, double-blinded, active-controlled, 2-way cross over trial~     to assess the effects of once daily administration of orally inhaled tiotropium + olodaterol~     FDC or tiotropium (both delivered by the RESPIMAT Inhaler) on pulmonary function (lung~     hyperinflation), exercise capacity (6-minute walk distance) and physical activities after 6~     weeks of treatment in Japanese patients with Chronic Obstructive Pulmonary Disease.~   "
71583|NCT02629952|"~     Plant derived compounds, e.g. flavonoids from dark chocolate, green tea, or blueberries, show~     great potential as nutraceuticals for the treatment of various diseases such as type 2~     diabetes (T2D). Flavonoids have been suggested to improve glucose metabolism, reduce blood~     lipids, reduce oxidative stress and improve vascular function. For these reasons we recently~     investigated the effects of daily consumption of locally produced blueberry tea and~     demonstrated that this could partially restore insulin sensitivity in an animal model. We~     propose to translate these findings to assess the efficacy of this nutraceutical as a new~     treatment for improving glucose tolerance in people with T2D.~   "
71584|NCT02629939|"~     Cardiac arrest is a public health problem and is the leading cause of death in many parts of~     the world.~      Cardiac arrest can occur inside the hospital and outside it. In the United States and Canada~     occur in approximately 350,000 cases of cardiac arrest a year , who receive CPR , Half of~     them outside the hospital.~      Treatment of cardiac arrest is performing Cardio Pulmonary Resuscitation (CPR) and early~     defibrillation.~      Performing compressions is the essential part of performing CPR until the arrival of~     defibrillation.~      Efforts are being made to simplify the implementation of basic CPR and make it accessible to~     everyone. Method hands only CPR offers CPR with compressions only without ventilations,~     Studies have shown a similar survival rate between hands only CPR method and CPR with~     ventilations.~      Patient's chances of survival are higher if a bystander begins performing CPR until trained~     medical staff arrives.~      Chances of survival decreases by 7-10% every passing minute past moment of collapse if not~     performed CPR.~      MDA survey carried out in 1984-5 reported at the start of CPR by a bystander at 8% Another~     survey in 2000 reported 14%, In a recent study in Jerusalem found a rate of only 15% of~     performing compressions by bystanders- A very low rate compared to 33% reported in the United~     States 41.3% in Japan and 44.9% in Denmark.~      The average time of arrival of the medical team in Israel is 10.3 minutes, so it is very~     important to begin performing CPR by those present before the arrival of medical staff.~      Most cases of cardiac arrest were the result of a previous cardiac disease, Therefore~     patients with cardiac disease are at higher risk of cardiac arrest and cardiac death.~      Place cardiac arrest is 72% percent of the time at home, and the likely presence of family~     members.~      The general population should know basic resuscitation to save a life, knowledge is needed~     especially among families of heart patients who are way more likely that such an event will~     occur in their presence.~      Therefore, one can relate to families of heart patients dedicated to increasing population as~     a basic knowledge of CPR.~      There is no other organized plan to study family members of patients with heart disease basic~     knowledge of CPR Despite the importance of it Attempts have been published in previous~     studies from around the world to create a focus group study of CPR among close relatives of~     heart patients. An attempt was made to incorporate as part of the proposed cardiac~     rehabilitation patients after MI Through self-study kit given at discharge from the hospital~     and more Difficult to evaluate the success of these efforts over the long term, but~     short-term study of short workshops yielded sufficient knowledge about basic CPR This study~     should serve as a catalyst as a first step towards building a suitable program nationwide and~     hopefully save many lives~   "
71585|NCT02629926|"~     Cure rates for childhood malignancies have improved at a remarkable pace.With the increasing~     cure rate came recognition of the long-term detrimental effects of radiotherapy and~     chemotherapy, known as late-effects. Endocrine late-effects are particularly prevalent in~     childhood cancer survivors. Growth Hormone (GH) deficiency is common following radiation to~     the head and leads to impaired growth, hence GH replacement is given to achieve optimise~     final height in childhood. In the adult GH is important to maintenance of bone, muscle & fat~     mass; vascular risk factors; and quality of life. This observational study aims to determine~     the long-term effect of low dose GH replacement on development of bone, muscle and fat mass;~     vascular risk; and quality of life in the early years after achievement of final height, a~     time known as transition. GH is thought to be essential to development of bone, muscle, and~     fat mass during this time period.~      Patients will be identified in the late -effects endocrine clinic, aged 16-22yrs, who are~     severely GH deficient. 30 patients will be recruited to the study who wish to continue~     receiving GH replacement, all of whom will receive recombinant GH. An additional 30 patients~     who do not wish to receive GH replacement will provide a parallel control data.~      All patients will undergo baseline assessment including examination; routine blood tests;~     urine dipstick; measures on height, weight, waist, and 24 hour blood pressure. Measures will~     be repeated at six months, and then annually until 25 years of age. Bone density will be~     measured at baseline, after two years and at age 25yrs. Patients requesting GH replacement~     will require initial additional visits to teach self injection, then 2-4wkly to assess when~     correct dose of GH is achieved. The study will enable assessment of the beneficial effects of~     GH replacement during transition in GH deficient survivors of cancer to be realised.~   "
71586|NCT02629913|"~     The Swiss company mementor has recently developed an interactive self-help intervention for~     the treatment of insomnia entitled mementor somnium. This programme is based on the~     guidelines for cognitive-behavioural therapy. mementor somnium consists of 6 online sessions.~     An animated personal sleep coach provides relevant audio-information and asks questions to~     which the patient is invited to respond. The components of the programme flexibly adapt to~     the patient's responses. Aside from psycho-education, exercises and an instruction for sleep~     restriction, mementor somnium includes a cognitive restructuring intervention in terms of a~     Socratic dialogue. This Socratic dialogue, implemented by the animated sleep coach, is based~     on a complex algorithm in the shape of an decision tree. University of Zurich's Department of~     Psychology in Switzerland will test the effectiveness of mementor somnium in a randomised~     controlled trial with three assessment times (pre, 6-weeks post and 3-months follow-up).~     Patients suffering from insomnia will be allocated randomly to either the active intervention~     group or the waitlist control group. Participants will have access to the programme mementor~     somnium for six weeks. Primary outcome measure is the Insomnia Severity Index, secondary~     outcome measures are Beck Depressions-Inventory revised (BDI-II), Brief Symptom Inventory 18,~     and the SF-12 Health Survey. Additionally, sleep diary data will be collected.~   "
71606|NCT02629653|"~     Aim of the study is to determine whether endovascular systemic cooling to a target~     temperature of 34-35°C initiated before, and maintained during Carotid EndoArterectomy (CEA),~     is feasible and safe~   "
71607|NCT02629640|"~     The purpose of this study to investigate if cases of Creutzfeldt-Jakob Disease (CJD) and~     other forms of prion disease are being missed in older adults living within Lothian.~   "
71868|NCT02626234|"~     the study aim to assess the effect of INC280 on the pharmacokinetics of digoxin and~     rosuvastatin in patients with cMET-dysregulated advanced solid tumors~   "
71587|NCT02629900|"~     Participants will complete a one-month intervention where they are will restrict their daily~     food intake to an 8-hour time period, i.e., between 1200 to 2000 hours. During the remaining~     16-hour intermittent fasting period (2000 to 1200 hours) participants will be allowed to~     drink zero calorie beverages (diet soda pop, black coffee, tea, water, etc) in order to~     maintain normal hydration. There will be no attempt to restrict food intake. Rather simply to~     restrict the time period each day when food is consumed. Participants' body mass, fat mass,~     and non-fat mass will be monitored non-invasively using a weigh scale and densitometry via~     air displacement (Bod Pod) at 0, 2 and 4 weeks following the dietary intervention. Also,~     participants will be interviewed following the final body composition measure to assess~     whether or not they continued to follow the intermittent fasting approach.~   "
71588|NCT02629887|"~     Prospective, randomized controlled trial to be performed at one center, of term and late~     preterm infants requiring resuscitation. Prenatal consent will be obtained. At randomization,~     babies will be resuscitated following Neonatal Resuscitation Program (NRP) guidelines and~     ventilated using the T-piece resuscitator with either a Face Mask (FM) or Non-inflating~     supraglottic airway. Video will be collected during resuscitation as well as written~     documentation. Primary outcome will be time to spontaneous breathing, length of~     resuscitation, and need for endotracheal intubation.~   "
71589|NCT02629874|"~     EA-230 is a newly developed synthetic compound with anti-inflammatory properties.~     Pre-clinical data indicate that EA-230 may be a valuable treatment for systemic inflammation~     resulting from a variety of causes such as surgery, trauma, infection, irradiation and~     others. Although previous studies in healthy volunteers have shown an excellent safety~     profile, the safety and tolerability of higher doses administered per continuous infusion~     need to be investigated. Also, the dose-effect relation on systemic inflammation needs to be~     further elucidated before a phase II trial in patients can be commenced.~   "
71590|NCT02629861|"~     The study is being conducted to evaluate two doses of TEV-48125 in adult patients with~     episodic migraine~   "
71591|NCT02629848|"~     This study will evaluate progression free survival (PFS), overall survival (OS), objective~     response rate (ORR), duration of response, and safety of motesanib (AMG706) in combination~     with paclitaxel and carboplatin compared to placebo in combination with paclitaxel and~     carboplatin.~   "
71592|NCT02629835|"~     Dexamethasone prolong the duration of brachial plexus blocks, but the optimal route,~     intravenous (IV) or perineural (PN), remains controversial.~      This Multi-centric trial compare IV and PN dexamethasone for ultrasound-guided axillary~     brachial plexus blocks (AXBs). Research hypothesis is that PN modality will outlast its IV~     counterpart. Since analgesic duration and sensory duration can be influenced by intake of~     pain medications and surgical trauma to small cutaneous nerves, the investigators will select~     motor block duration as the main outcome.~   "
71593|NCT02629822|"~     The primary objectives of this study are to evaluate the antiretroviral activity and to~     evaluate the safety and tolerability of open-label MK-1439A consisting of a single fixed-dose~     combination (FDC) tablet of MK-1439 100 mg/lamivudine 300 mg/tenofovir disoproxil fumarate~     300 mg in treatment-naive HIV-1 infected participants with selected NNRTI transmitted~     resistance mutations.~   "
71594|NCT02629809|"~     The goal of this clinical research study is to learn if the combination of ibrutinib,~     fludarabine, cyclophosphamide, and obinutuzumab can help control chronic lymphocytic leukemia~     (CLL). The safety of this drug combination will be also studied.~      This is an investigational study. Ibrutinib, fludarabine, cyclophosphamide, and obinutuzumab~     are all FDA approved and commercially available for the treatment of patients with CLL. The~     use of these drugs in combination is investigational. The study doctor can explain how the~     drugs are designed to work.~      Up to 100 participants will be enrolled in this study. All will take part at MD Anderson.~   "
71595|NCT02629796|"~     This study aims analyze the transcriptome to identify predictive biomarkers of IVIG in CIDP~     patients. 25 patients with a diagnosis of CIDP according to European criteria, naïve of~     treatment, will be included and followed for 1 year. Clinical assessment (RT-MRC ; Martin~     vigorimeter, RT-mISS,R-ODS,TW25, 9hole-peg test) will be performed at baseline and at 3, 6~     and 12 months after the first IVIG course. Responder/No responder status will be defined at 3~     month and confirmed at 12 months. Blood samples will be collected before the IVIG course at~     baseline, and at 2months and 6 months. At the end of the first IVIG course a blood sample~     will be collected to assess early changes of transcriptome. The CIDP diagnosis and~     responder/no responder status will be confirmed by an independent committee. The~     transcriptome of the patients will be individually analyzed and compared regarding~     Responder/Non responder status to a control groups of 20 healthy subjects~   "
71596|NCT02629783|"~     Some patients with shoulder pain have decreased body awareness (BA). To some degree, pain~     among these patients can be increased due to their lack in BA. Psychomotor therapy is thought~     to improve BA and thereby increase the effect of traditional therapy, such as physiotherapy~     and exercises.~      The aim of this study is therefore to investigate if psychomotor therapy, as a complimenting~     treatment to physiotherapy, decreases shoulder patients' function deficits and pain reported~     on PRO's, compared to physiotherapy alone.~   "
71608|NCT02629627|"~     In Mexico, obesity is a major public health problem. In recent years he has presented a~     considerable increase in the population. As a result, it has triggered a proportional~     increase in the incidence of cardiovascular disease and the development of Metabolic Syndrome~     (METS). Abdominal obesity is one of the main components of METS which is generally associated~     with insulin resistance / hyperinsulinemia. This is influenced both by the subcutaneous~     adipose tissue as visceral adipose tissue. There is evidence that the visceral fat has an~     important bearing on many factors of METS, like: glucose intolerance, hypertension,~     dyslipidemia, and insulin resistance.~      For management it requires a multidisciplinary approach, including changes in lifestyle,~     psychological and nutritional intervention as well as pharmacological and non-pharmacological~     support.~      Among non-pharmacological therapies, there is recently the use of Conjugated Linoleic Acid~     (ACL) and leucine where in its assigned properties include weight reduction, anti-atherogenic~     , hypocholesterolemic and immunostimulant effect and anticarcinogenic properties. Regarding~     weight reduction dominates the mechanism of action anti-lipolytic effect. But, studies are~     needed to link this consumption with the increase or decrease on visceral fat in individuals~     with METS.~   "
71597|NCT02629770|"~     Treatment of bone and joint infections remains difficult and variable according to centres~     and countries. Clindamycin given intravenously and followed by an oral route is recommended~     for the treatment of staphylococcal, streptococcal and anaerobes bone and joint infections by~     the French Society for Infectious Diseases. For staphylococcal bone and implant infections,~     rifampin is a major drug, as it remains active in bacterial biofilm and on quiescent~     staphylococci. For that reasons, clindamycin-rifampin combination therapy is frequently used~     in these infections.Clindamycin is metabolized by the P450 3A4 cytochrome, an enzyme strongly~     inducible by rifampin. A retrospective study published in 2010 on 70 patients treated for~     bone and joint infections showed that clindamycin serum concentrations were significantly~     lower when clindamycin was combined with rifampin (5.3 mg/liter vs 8.9 mg/liter; p<0.02).~     This drug interaction could even be stronger with the oral route, because of hepatic~     first-past effect, ending up with very low clindamycin serum concentration, a risk of~     selecting resistant microorganisms and treatment failure. This latter point is an important~     issue, because clindamycin has an excellent oral bioavailability and is frequently used in~     oral regimens. In the above study, a wide variability of clindamycin serum concentration was~     observed in the group of patients treated with combination therapy (1-12mg/l) suggesting~     interindividual variability. Rifampin induction of CYP 450 3A4/A5 depends on different~     receptor (PXR, RXR, LXRalpha) submitted to genetic polymorphism. Hypothesis: Plasma clearance~     of clindamycin (CLclin) combined with rifampicin (CLclinrif) is higher when clindamycin is~     administered by the oral route (CLclinrif OR) compared with IV administration (CLclinrif IV).~   "
71598|NCT02629757|"~     This study is being conducted to help determine whether β-elemene as maintain treatment for~     complete remission patients of newly diagnosed malignant gliomas following standard~     treatment, is able to delay tumor growth, or impact how long people with newly diagnosed~     high-grade glioma.~   "
71599|NCT02629744|"~     This study is a multi-center, single-arm, open-label study in healthy participants to assess~     the pain, tolerability, injection leakage, safety, and usability of a single~     self-administered subcutaneous (SC) dose of etrolizumab. Some participants will receive~     needle-experience training using a needle and syringe on Days -7 and -5, and health care~     professionals (HCPs) will then assess the participant's suitability to self-inject with a~     prefilled auto-injector (AI). The remainder of participants will be needle naïve and will~     not have previously self-injected. Eligible needle experienced and needle naive~     participants will attend an AI training visit at the study site on Day -3 (three days prior~     to etrolizumab dosing on Day 1). Following training and simulated injections by the~     participant the HCP will determine if the participant is suitable to proceed to actual~     etrolizumab dosing. All eligible study participants will self administer a single dose of~     etrolizumab (by AI) on Day 1 and will be followed up to Day 85 following dosing. Pain,~     tolerability, safety and usuability will be assessed.~   "
71600|NCT02629731|"~     This study will investigate the effect of foot orthoses on two common conditions (ankle~     osteoarthritis and symptomatic adult onset flat feet) by using a custom biplane X-ray system~     the group has developed to very accurately and precisely quantify foot bone motion. The~     investigators will vary the design of the orthoses and subjects will be examined to find out~     which are most effective at improving function.~   "
71601|NCT02629718|"~     To clarify the potential benefits of NACT before radical surgery(RS), we perform a phase III,~     randomised controlled trial to compare NACT plus RS with RS alone in patients with stages IB2~     and IIA2 cervical cancer.~   "
71602|NCT02629705|"~     The purpose of this study is to determine whether the ingestion of the common food additive~     carrageenan contributes to insulin resistance and thus to the pathogenesis of type 2 diabetes~     in humans.~   "
71603|NCT02629692|"~     Phase 1/2 study to determine safety, tolerability, pharmacokinetics and activity of K0706~   "
71604|NCT02629679|"~     Adolescent substance abuse (SA), which includes the consumption of alcohol, cigarette~     smoking, the consumption of drugs and other behaviors, is a significant public-health issue~     in the world today. Recent data showed that prevalence of SA among adolescents in Croatia and~     surrounding countries (i.e. former Yugoslav republics) is alarming and needs serious~     intervention. It is hypothesized that participation in physical-exercise-and-sport (PE&S)~     will reduce the tendency of young people to abuse substances. However, the literature to date~     has not consistently validated the perception PE&S factors are factors which could buffer SA~     among children and adolescents. One of the probable reasons for evident inconsistencies on~     findings about relationship between PE&S and SA is a cross-sectional nature of studies done~     so far. Therefore, the main rationale (i.e. problem) of this study is lack of current~     knowledge about influence of the PE&S on SA among adolescents. The main objective of this~     study is to prospectively investigate the influence of PE&S on SA among adolescents aged 17~     to 18 years old. Aims of the project are: (1) to define prevalence and trends of SA among~     adolescents aged 17 to 18 years old; (2) to define prevalence and trends of PE&S~     participation; (3) to establish interrelationships which exist between socio-demographic,~     psychological, educational-factors, and PE&S (predictors); (4) to identify multivariate and~     univariate associations between: socio-demographic and SA, psychological factors and SA, PE&S~     and SA, educational - scholastic factors and SA.Expected results of the project are: (1)~     definition of the prevalence of SA among adolescents; (2) definition of the adolescents'~     participation in PE&S; (3) identification and interpretation relationships which exist~     between and within studied predictors of SA (educational factors, socio-demographic factors,~     PE&S, psychological factors); (4) identification of the influence of studied predictors on~     SA.~   "
71605|NCT02629666|"~     The increase of the elderly population leads to increased prevalence of frailty, risk for~     poor health outcomes, and related health and social care costs. Lack of physical activity~     (PA) and established sedentary behaviours (SB) constitute an additional burden, as they are~     related to progression of chronic disease and disabling conditions. An existing initiative to~     battle SB and insufficient PA levels are exercise referral schemes (ERS) implemented in~     primary care, where insufficiently active individuals are referred to a third party service~     (sports centre or leisure facility) that prescribes and monitors an exercise programme~     tailored to the patients' needs. ERS had shown improvements in PA in the short-term, but may~     have limited power to change SB and produce long-term effects. Thus, ERS might be enhanced by~     self-management strategies (SMS) to promote behavioural change. Such strategies based on~     social cognitive theory have been shown to increase self-confidence, power to act, and~     involvement in exercise. In a first stage, a systematic review, focus groups and a~     feasibility study will be conducted. Then, a three-armed pragmatic randomized controlled~     trial (RCT) will assess the long-term effectiveness (18-month follow-up) of a complex~     intervention on sedentary behaviour (SB) in an elderly population, based on existing ERS~     enhanced by self-management strategies (SMS). It will be compared to ERS alone and to general~     recommendations plus two educational sessions. The RCT will include 1338 subjects and will~     have a follow up of 18 months. The effect on SB will be measured as sitting time and the~     number of minutes spent in activities requiring ≤ 1.5 Metabolic Equivalent Tasks, and PA as~     daily counts per minute and intensity of exercise, and daily step counts. Secondary outcomes~     will include: physical function, healthcare use and costs, anthropometry, bioimpedance, blood~     pressure, self-rated health and quality of life, activities of daily living, anxiety,~     depressive symptoms, social network, physical activity self-regulation, self-efficacy for~     exercise, disability, fear of falling, loneliness, executive function, and physical fatigue.~     In a subsample, the level of frailty-associated biomarkers and inflammation, and~     sarcopenia-associated markers of muscle quality will be analysed. A process evaluation will~     be performed throughout the trial. SITLESS will assess policy makers in deciding how or~     whether ERS should be further implemented or restructured in order to increase its adherence,~     efficacy and cost-effectiveness.~   "
71615|NCT02629536|"~     Migraine affects 15% of Western Australians and is a leading cause of suffering and~     disability in our community (1,2). Research suggests that inflammation of the brain's~     coverings (meninges) by nerve cell inflammation and the release of 'free radicals', is a~     cause of migraine. N-acetylcysteine, Vitamin E and Vitamin C are powerful anti-oxidants~     (free-radical scavengers) that reduce brain inflammation and nerve activity. It is therefore~     possible these anti-oxidants could reduce the number and severity of migraines. We will study~     90 subjects to see if a combination of N-acetylcysteine 600 mg, Vitamin E 250 IU and vitamin~     C 500 mg (NEC) taken twice daily for 3 months, will reduce migraine attacks. This safe~     vitamin-based therapy has never been studied and if effective, will play an important role in~     migraine prevention.~   "
71616|NCT02629523|"~     Treatment efficacy of afatinib will be assessed in patients with lung cancer harboring EGFR~     mutations which were detected from circulating tumor DNA.~   "
71617|NCT02629510|"~     This study is aimed at identifying the efficacy of Tachosil® for prevention of hemorrhage in~     patients with cervical intraepithelial neoplasia or cervical cancer after undergoing a loop~     electrosurgical excisional procedure (LEEP).~        1. Primary endpoint:~           Bleeding period within two weeks after surgery Frequency of additional treatment due to~          bleeding within two weeks after surgery~        2. Secondary endpoint:~      Amount of bleeding within two weeks after surgery Infection frequency at external genitals,~     vagina and cervix within two weeks after surgery Change in life quality after surgery~   "
71618|NCT02629497|"~     This study investigates the potential protective effects of fatty acid supplementation~     through inhibition of platelet activation. fatty acids (omega-3 and omega-6) will be~     evaluated for protection from agonist-mediated platelet activation in platelets from type 2~     diabetics and healthy controls. Post-menopausal women with type 2 diabetes mellitus and~     healthy post-menopausal women will be treated with omega-3 and omega-6 fatty acid supplements~     to determine protection from platelet activation and thrombosis in this high risk population.~   "
71619|NCT02629484|"~     Hip fracture surgery is a major world health care burden and concern, as it has a large and~     increasing prevalence and carries very high patient mortality, disability and community~     health care cost. As the commonest cause of mortality is from cardiac complications, and~     cardiac disease is prevalent and frequently missed by standard care, we hypothesise that~     earlier and more accurate diagnosis and treatment of cardiac pathology in this cohort will~     lead to improved outcome. Focused cardiac ultrasound (FCU) is a new increasingly popular~     technique used by doctors that enables earlier and more accurate diagnosis of cardiac~     disorders that can be performed routinely before hip fracture surgery. Our preliminary data~     of 64 patients demonstrated that routine FCU before surgery lead to a change in cardiac~     diagnosis and management in 50% of patients requiring hip fracture surgery, which was~     associated with a 50% reduction in mortality 12 months after surgery compared with controls.~     It is therefore important for a large randomised trial to be performed to confirm or rebuke~     these findings, as if true, would have a very large impact on health care and may also~     improve health care and outcome in other high-risk surgical populations. The proposed pilot~     study is a pilot study which aims to establish feasibility, safety, compliance and group~     separation prior to commencing a definitive multicentre trial.~   "
71620|NCT02629471|"~     Background The goal of this study is to examine the human visual and cognitive performance~     under the effect of bright light pulses. Exposure to visual stimulation of such pulsation may~     interfere with cognitive function and at certain situations this may be noticeable and may~     interfere with our judgment and abilities. In some of them visual or cognitive impairment~     from exposure to bright light flashes may result in catastrophic outcome due to the high-risk~     situation e.g. road accidents. Ocular exposure to a bright light can result in profound~     momentary transitional loss of vision. The light sources employed for visual stimulation in~     this study will be restricted to the range consistent with reversible effects (e.g. glare~     and flash insensitivity or flash blindness).~      The impact of an exposure to bright light depends not only on the exposure level and~     frequency, but also on the exposed individual's activity, psychological state, adaptation~     level and visual task. Glare is primarily caused by the scattering of light within the eye~     due to the imperfect transparency of the optical components of the eye and to a lesser extent~     by diffuse light passing through the scleral wall or the iris. The scattered light overlays~     the retinal image, thus reducing visual contrast. Excessive glare may impair visual function~     and lead to temporary disability.~      The above mentioned effects of exposure to light and pulsating light stimulus on the visual~     system and cognition were studied in detail by a number of groups. These studies indicate~     that the visual and cognition effects of pulsating light are a function of the following~     parameters: pulse duration, light intensity and pulse frequency.~   "
71621|NCT02629458|"~     Stage I non-small cell lung cancer (NSCLC) is curable and surgery is considered the standard~     of care for fit, good performance status patients. However, a high proportion of patients~     with stage 1 NSCLC are elderly and/or have medical co-morbidities and are therefore at higher~     risk of surgical complications. The optimal treatment for these patients is unknown. SABR may~     be an equally appropriate treatment but this need to be formally assessed. Funded by the NIHR~     Research for Patient Benefit, SABRtooth is a UK multi-centre, two-group individually~     randomised controlled feasibility study of patients with peripheral stage I non-small cell~     lung cancer considered at higher risk from surgery. In total, 54 patients are planned to be~     recruited from 4 treatment sites and 2 referral sites. This study aims to determine the~     feasibility and acceptability of performing a largescale definitive randomised phase III~     trial comparing surgery with stereotactic ablative radiotherapy (SABR). The qualitative~     substudy is an exploration of the reasons for nonparticipation in the SABRTooth trial. As the~     two treatments are very different, patients may have a strong preference for either surgery~     or SABR, or may feel uncomfortable to have a decision between such distinct options taken out~     of their hands. Understanding why patients choose not to participate or do not take up their~     treatment allocation will be crucial in demonstrating that recruiting to a larger scale phase~     III trial is feasible. We will explore what patients, who have declined particpation in the~     study or who intiailly consented but subsequently fail to take up their randomimsed treatment~     arm, understand, perceive and feel about, how the SABRTooth trial was presented to them and~     their expectations of study burden.~   "
71622|NCT02629445|"~     People that have survived, or are at high risk of a lifethreatening ventricular arrhythmia~     are routinely offered a defibrillator (ICD). An ICD is an implanted device which can~     recognise a ventricular arrhythmia and then try to treat it, either by rapidly pacing the~     heart or by shocking the heart. Currently, very fast ventricular arrhythmias, known as VF,~     can only be treated with a shock. Patients find shocks painful and this study is intended to~     find out whether it is possible to pace the heart at very high rates during VF. It is hoped~     that if this is possible, further research could lead to effective treatment of VF with~     pacing rather than shocks, and therefore better outcomes for patients.~   "
71623|NCT02629432|"~     The main objective of this trial is to prove that MRI - as the imaging modality without the~     use of ionizing radiation - can replace CT for structural and functional regional phenotyping~     of COPD. The identification of different COPD phenotypes, such as the emphysema-type and~     the airway-type, is important because therapy and prognosis will be different. The medical~     problem addressed in this trial is the image-based phenotyping of COPD. The sensitivity and~     specificity of MRI will be compared to Lowdose-CT serving as the gold standard. MRI and CT of~     the lung will be performed in a multi-centre cohort of 625 COPD-patients from the main~     COSYCONET cohort. The reliability of the MRI results will be demonstrated. MRI phenotypes~     will be evaluated visually and using software with quantitative read-outs. The agreement of~     both will be determined. The additional information of MRI over CT will be assessed.~   "
71624|NCT02629419|"~     This is an open-label, dose-titration trial to study the efficacy, safety, and~     pharmacokinetics of oral cochleate amphotericin B (CAMB) in the treatment of mucocutaneous~     candidiasis infections in patients who are refractory or intolerant to standard non~     intravenous therapies.~   "
71625|NCT02629406|"~     The general aim of this study is to define the response to hypoxic challenge in patients with~     diabetes. The investigation will provide response for different questions that are central~     for explaining the development of complications in diabetes~        -  have patients with diabetes an impaired reaction to adapt to hypoxia~        -  what consequence has hypoxia challenge on respiratory and on cardiovascular regulation~          in patients with diabetes~        -  what consequence has diabetes on the angiogenetic response to hypoxia~   "
71626|NCT02629393|"~     To evaluate the safety and efficacy of ALXN1101 in neonate patients with MoCD Type A~   "
71627|NCT02629380|"~     The rational of intra-articular viscosupplementation is based on both the biological and~     mechanical properties of HA, which exerts positive effects on the modulation of the entire~     joint environment.~      The aim of the present double blind controlled study was to evaluate the effects in terms of~     pain control and functional recovery provided by a single intra-operative injection of HA~     performed at the end of arthroscopic partial meniscectomy.~      Patients included in this trial were randomized in two treatment groups: the first one~     received a single injection of HA (Hymovis 24 mg/3ml, Fidia Farmaceutici Spa, Padova, Italy)~     at the end of the arthroscopic meniscectomy, whereas the second group was treated by surgery~     alone.~      All patients were evaluated basally, at 15, 30, 60, and 180 days after surgery by the~     following evaluation tools: IKDC (International Knee Documentation Committee) subjective, VAS~     (Visual Analogue Score) for pain, EQ-VAS for general Health Status, KOOS (Knee Injury and~     Osteoarthritis Outcome Score) and Tegner score. Furthermore, during the basal evaluation and~     at each follow-up visit up to 2 months, active and passive Range of Motion (ROM) of both the~     operated and contralateral knee were documented; also in addition, the trans-patellar~     circumference of both knees was registered to assess the trend of knee swelling over time.~   "
71628|NCT02629367|"~     Currently, there are no data available regarding the effect of vorapaxar on clot generation~     kinetics or TIP-FCS when added to standard of care antiplatelet regimens. Potential reduction~     of TIP-FCS and clot generation kinetics by vorapaxar may assist in our understanding of the~     mechanism of action and in personalizing therapy in high risk patients to effectively reduce~     recurrent thrombotic event occurrences. The objective of this study is to determine onset-,~     maintenance-, and offset-effect of vorapaxar on platelet-fibrin clot generation kinetics by~     thrombelastography (R, TIP-FCS, TG) and thrombin generation kinetics (Lag time, peak thrombin~     production, time to peak thrombin generation, and endogenous thrombin potential) in~     antiplatelet naïve patients and patients on mono and dual antiplatelet therapy. This is a~     phase IV, prospective cohort (4 groups), non-randomized, open label, pharmacodynamics, and~     safety investigation.~   "
71629|NCT02629354|"~     The objective of the trial is to compare to combination of 400 mg ibuprofen and 100 mg~     caffeine against 400 mg ibuprofen alone under fed conditions~   "
71630|NCT02629341|"~     The purpose of this study was to evaluate the therapeutic effect of a functional yogurt~     powder on menopausal, middle-aged women at high risk of osteoporosis. The functional yogurt~     powder containing Calcium, D, K, C vitamins, Zn, Mg, L-leucin and the Lactobacillus plantarum~     3547 probiotic, was developed to benefit bone health and in the long term may contribute to~     the prevention of osteoporosis.~   "
71631|NCT02629328|"~     This study will quantify the safety and efficacy of the CardioCel implant in tri-leaflet~     repair. 80 patients in up to 7 sites in Europe and the US will all be treated with the~     CardioCel implant.~   "
71632|NCT02629315|"~     This study evaluates the number of lymph nodes dissected in rectal cancer specimens following~     fixation with 10% neutral buffered formaldehyde or Carnoy's solution. Half of the specimens~     with be fixed in each solution.~   "
71633|NCT02629302|"~     The study investigates the effects of animal-assisted therapy on patients with severe~     disorders of consciousness. The focus lies on the short-term biopsychosocial effects that~     occur when animals are present during therapy sessions in comparison to therapy sessions~     without animals, observing a group of 10 patients during 16 therapy sessions.~      While half of the sessions are held in presence of an animal and half without, they are as~     comparable as possible with respect to content and setting. In this study, patients in a~     minimal conscious state are recruited.~   "
71634|NCT02629289|"~     This study is for healthy participants. This study tests single dose of the research drug~     HSP-130 against two existing approved drugs United States - approved Neulasta and European~     Union-approved Neulasta.~   "
71635|NCT02629276|"~     The aim of this study was to evaluate potential differences in somatosensory function in~     patients with unilateral NSNAP with and without positive ND compared to healthy controls.~     Furthermore, we determined whether there are any differences between groups in symptom~     severity, functional deficits, psychological parameters, quality of life and sleep.~   "
71636|NCT02629263|"~     Purpose of Study (The Effect of Viscous Fiber on Glycemic Control (VF & GC) in Individuals~     with Diabetes Mellitus.~      According to the World Health Organization, about 347 million individuals are living with~     diabetes. (http://www.who.int/features/factfiles/diabetes/facts/en/, accessed on Nov. 23,~     2015). Over the last decades, dietary fibers, namely dietary viscous fibers, have emerged as~     a nutrition component that may improve the postprandial glycemic response and hence aid in~     long term diabetes management. It is believed that supplementation with viscous fibers can~     control blood glucose by increasing viscosity of the gastric digesta, hence delaying gastric~     emptying and retarding entry of glucose into the bloodstream to result in a diminished~     postprandial rise in blood glucose. (Chutkan et al., 2012).~      Currently, the evidence of the relationship between viscous fibers and diabetes is mixed. The~     systematic review method depends on combining data from many small studies in order to get a~     pooled estimate of the true effect. The purpose of this study is to conduct a systematic~     review and meta-analysis of randomized controlled trials (RCTs) investigating the fasting~     glycemic and insulinemic effect of viscous fiber supplementation. We hope the findings of~     this study will play a key role in developing the nutritional guidelines for individuals with~     diabetes mellitus.~   "
71637|NCT02629250|"~     Elderly patients with poor cardiopulmonary reserve tend to suffer higher risk and develop~     more complications following major surgery. Quite a few researches have shown the benefits of~     goal-directed therapy (GDT) using fluid loading or inotropic agents or both to improve~     outcome during major surgery. However there is concern that inotropic therapy for a~     supernormal oxygen delivery (DO2I) may lead to an increased incidence of myocardial ischemia.~     Even though the meta-analysis has stated that DO2I strategy could possibly reduce the~     incidence of cardiac complication than stroke volume optimization strategy, there are very~     few evidence available in the literature regarding the effect on myocardial ischemia in~     surgical patients, especially in non-cardiac surgical patients. This study is undertaken to~     test the hypothesis that an intraoperative DO2I optimization result in a decreased myocardial~     ischemia in the elderly high-risk surgical patients.~   "
71638|NCT02629237|"~     1. Investigate degree of postoperative satisfaction in county level hospital glaucoma~          patients.~        2. Investigate the effect of educational intervention affect the degree of satisfaction in~          glaucoma patients.~        3. Investigate the effect factors of postoperative satisfaction.~   "
71639|NCT02629224|"~     The objective of this study is to evaluate the pharmacokinetics and safety of ASP8825 in~     patients with impaired renal function and haemodialysis.~   "
71640|NCT02629211|"~     To evaluate the safety and efficacy of the NaviAid™ AB in children with known or suspected~     IBD.~   "
71641|NCT02629198|"~     There is current interest in the role of vitamin D in the prevention and treatment of many~     chronic diseases, including osteoporosis, cancer and neurological disease. The majority of~     vitamin D in the UK comes from the action of sunlight on skin, and very little from dietary~     sources. Half of the adult United Kingdom (UK) population have vitamin D insufficiency~     (according to the Institute of Medicine definition). There are still several important~     unknowns, including what the optimum levels of vitamin D are, and whether the same intake of~     vitamin D is appropriate for all sections of the population.~      Low 25(OH)D and high parathyroid hormone (PTH) have been observed in people with high~     adiposity (obesity), and the summer rise in vitamin D is blunted in obesity. The potential~     causes of low 25(OH)D levels include an inadequate supply of vitamin D (by reduced sunlight~     exposure or poor nutrition), the large pool size of adipose tissue or increased metabolic~     clearance rate.~      The investigators will measure metabolites of vitamin D and the kinetics of 25(OH)D using~     stable isotope techniques in lean, overweight and obese men, women and children to establish~     whether age, gender and obesity affect vitamin D metabolism and clearance rate.~      If low 25(OH)D in obesity is related to poorer skeletal health and is due to increased~     clearance of 25(OH)D or large pool size, then total requirements, and hence supplementation~     requirements, would be larger for obese people than for lean people.~   "
71642|NCT02629185|"~     High body weight is protective against hip and spine fracture, but has been found to increase~     the risk of humerus, foot and ankle fracture. Increasing understanding of the actions of~     adipokines on bone suggests that there may be complex effects on different aspects of bone~     geometry and microarchitecture and that these effects may vary depending on whether~     adipokines act directly on bone cells or through the central nervous system and between~     cortical and trabecular compartments. Previous research is limited by the use of areal~     dual-energy x-ray absorptiometry (DXA) scans which may be inaccurate in obese populations due~     to increased body thickness.~      The aim of this study is to investigate the effect of obesity on bone mineral density, bone~     geometry, bone microarchitecture and bone strength of the hip, lumbar spine, distal radius~     and tibia.~      This is an observational, cross-sectional study of normal weight and obese individuals~     matched by age, gender, height, postcode and smoking. The total number of subjects will be~     240; men and premenopausal women ages 25 to 40 years and men and postmenopausal women ages 55~     to 75 years. DXA, high-resolution peripheral computed tomography (HR-pQCT), quantitative~     computed tomography (QCT) and finite element analysis will be used to assess bone structure~     and strength. Biochemical markers of bone turnover and hormones related to bone metabolism~     will also be measured in order to identify potential mediators of the effects of obesity on~     bone structure and strength.~      A sub-study has been included to evaluate the interaction of fracture risk and cardiovascular~     risk in obese and non-obese individuals. There is evidence of an interaction between bone~     mineral density (BMD) and cardiovascular risk and test the hypothesis that there are common~     pathways linking BMD and cardiovascular risk, including fat secretion of inflammatory~     cytokines e.g. interleukin-1 and adipokines e.g. leptin and adiponectin. Ultrasound based~     assessments of vascular function will be used to assess cardiac risk and relate these~     measures to bone density.~      Obese individuals have lower circulating levels of 25OHD. This may be due to poor nutritional~     intake, reduced sunlight exposure or the vitamin D being stored in fat tissue. The~     investigators will measure levels of 25OHD in lean, overweight and obese men and women to~     examine whether 25(OH)D is related to age or gender and whether low 25OHD in obesity affects~     bone health in subsets of lean, overweight and obese participants of different ages.~   "
71643|NCT02629172|"~     The main objective of this study is to evaluate the safety and effectiveness of~     paritaprevir/ritonavir/ombitasvir used for patients infected with HCV genotype 1 in daily~     practice in Japan.~   "
71644|NCT02629159|"~     This is a phase 3, randomized, double-blind study comparing ABT-494 to Placebo and to~     Adalimumab in subjects with moderately to severely active rheumatoid arthritis who are on a~     stable background of Methotrexate (MTX) and who have an inadequate response to MTX.~   "
71645|NCT02629146|"~     This study evaluates analgesic properties of midazolam compared to placebo and fentanyl. Each~     participant will receive all three drugs (midazolam, fentanyl, placebo) on three different~     occasions (study visits) and the effect on different pain stimuli will be tested.~   "
71646|NCT02629133|"~     This study developed and assessed an innovative, high-reach, easily implementable, low-cost~     computer-delivered intervention (Safe and Healthy Experiences; The SHE Program) that~     addresses known barriers in early identification and intervention with sheltered battered~     women with IPV (intimate partner violence) and substance use.~   "
71647|NCT02629120|"~     Chronic granulomatous disease (CGD) affects white blood cell function. Currently, the only~     curative treatment is bone marrow transplant to replace the abnormal stem cells with new ones~     (donor cells) capable of making a normal immune system. Transplant problems include graft~     versus host disease (GvHD) and graft rejection. With GvHD, donor cells attack the recipient s~     normal tissue. Researchers want to use preparation drugs and a high cell dose to increase~     graft success. They want to use 2 immunosuppressive drugs (cyclophosphamide and sirolimus) to~     lessen the risk of GvHD.~   "
71648|NCT02629107|"~     Background:~      An electroencephalogram (EEG) measures the brain s electrical activity. EEG shows that the~     louder the sound needed to wake a person, the deeper the person s sleep. Researchers are~     using functional magnetic resonance imaging (fMRI) to study people during sleep so they can~     view brain activity in 3D. But they still need to correlate fMRI with sound thresholds, like~     the EEG.~      Objective:~      To measure brain activity during sleep using fMRI and EEG.~      Eligibility:~      Healthy people ages 18 34 who can sleep on their back for several hours.~      Design:~      Participants will be screened online about their sleep and general health.~      At a screening visit, participants will have:~      Physical exam~      Hearing exam~      MRI scan. A strong magnetic field and radio waves take pictures of the brain. Participants~     will lie down on a bed that slides into the scanner, which is shaped like a cylinder.~      Participants will wear an actigraph on their wrist that records their motor activity.~      Participants will follow a 2-week routine. This includes regular in-to-bed and out-of-bed~     times and limits on alcohol, caffeine, and nicotine.~      At the 3-day inpatient visit, participants will have:~      Hearing exams.~      Female subjects will have a urine pregnancy test.~      fMRI. A coil will be placed over the head. Participants will do tasks shown on a computer~     screen inside the scanner.~      EEG. Small electrodes on the scalp will record brain waves while sleeping or doing a task in~     the scanner.~      Participants will be asked to try to sleep while researchers collect fMRI and EEG data.~     Participants eyes will be monitored with a video camera. Headphones will deliver sounds to~     wake them up throughout the night.~   "
71649|NCT02629094|"~     Background:~      People with human immunodeficiency virus (HIV) are at a high risk of getting visceral or deep~     belly fat. Visceral fat can cause health problems like heart or liver disease. Researchers~     want to see if a blood pressure drug can help by blocking a hormone in the body.~      Objective:~      To see if eplerenone reduces fat stored in the heart muscle and liver in people with HIV and~     increased visceral fat.~      Eligibility:~      Adults ages 18 75 with HIV and increased waist circumference. Increased waist circumference~     is defined as more than 40 inches in men and more than 35 inches in women.~      Design:~      Participants will be screened with:~      Physical exam~      Medical history~      Blood tests~      Measurements of hips, waist, legs, arms, shoulders, and neck~      Magnetic resonance imaging (MRI) scan. They will lie on a table that slides into a machine.~      Electrocardiogram (EKG) to measure heart electrical activity~      Transient elastography, a special ultrasound to measure liver tissue stiffness~      A small piece their liver collected (optional)~      Participants will have a baseline visit:~      Physical exam~      Medical history~      Blood tests~      DEXA scan to measure body fat, muscle mass, and bone density. Participants will lie on a~     table while a very small dose of x-rays goes through the body.~      Resting energy expenditure (REE). This measures the amount of oxygen breathed in and carbon~     dioxide breathed out.~      Participants will get a 1-week supply of eplerenone. They will take one pill per day.~      Participants will have a follow-up visit 1 week later. They will have:~      Physical exam~      Medical history~      Blood tests~      23-week supply of eplerenone~      Participants will have 5 more follow-up visits.~      Participants will have a final study visit, repeating many of the screening and baseline~     tests.~   "
71650|NCT02629081|"~     When treating persistent heartburn from gastroesophageal reflux disease (GERD) that does not~     respond to conventional treatment (a class of medications called proton pump inhibitors), it~     is important to be able to distinguish between erosive GERD and non-erosive GERD (called~     NERD).~      Currently the best method the investigators have to make this distinction is esophageal~     24-hour pH and impedance testing. The test involves inserting a catheter into the esophagus~     through the nose and having the catheter maintained in this position for 24 hours This test~     is invasive, can be uncomfortable, and it is expensive and time consuming.~      The investigators are hoping that image enhanced technology will identify characteristics~     that are found more commonly in patients with non-erosive GERD compared to controls and~     therefore provide evidence that may allow us to replace pH and impedance testing with the~     image enhanced endoscopy as the best way to diagnose NERD.~      Participants will be either patients undergoing an upper endoscopy as part of their standard~     clinical evaluation for heartburn that does not respond to PPIs or patients undergoing~     standard clinical evaluation endoscopy for other reasons.~   "
71651|NCT02629068|"~     The purpose of this study is to develop and test a social media-based (Facebook) intervention~     that provides support and skills to parents with adolescent children in treatment for~     substance abuse. The Facebook intervention, PURPOSE, will be 8 weeks long and led by other~     parents (peer leaders). Peer leaders will go through 2 2-3-hour training sessions and be~     assessed at the end to confirm their understanding of study protocol and procedures. The~     study PI will lead 2 short (2-weeks) trial tests of various segments of the intervention to~     test out content and procedures. Then, a pilot trial with 80 parents, 40 randomized to~     PURPOSE and 40 randomized to treatment as usual (TAU), will be done to test how useful~     PURPOSE can be in promoting parents' engagement in their child's treatment and recovery while~     reducing their own distress and feelings of shame/stigma. Parents will do a phone interview~     at the start of PURPOSE and again at the end of the 8 weeks.~   "
71652|NCT02629055|"~     The aim of the present study is to investigate whether additional titration on surface~     electromyography (EMG) of the diaphragm and intercostal muscles improves the outcome of~     chronic non-invasive ventilation in patients with COPD and stable chronic hypercapnic~     respiratory failure in terms of better gas exchange after six weeks, lung function, patient~     comfort and compliance, and less patient ventilator asynchrony. Therefore, the investigators~     set up a randomized, two-armed crossover trial comparing regular titration with additional~     respiratory EMG titration of NIV.~   "
71669|NCT02628834|"~     Ten patients who were referred to receive physiotherapy and 10 healthy volunteers will be~     participants of the study.Following the initial evaluation, participants with multiple~     sclerosis will take the fascial mobilization for their posterior crural muscle group and~     hamstring distal tendons which connects the crural bones at first day. After the day~     following the first visit participants will asked to come again and stretching exercises will~     apply to plantar muscle groups after the evaluation. Every participants will evaluate with~     the following assessment tools: Modified Ashworth scale will use to evaluation of severity of~     plantar flexor spasticity. Static and dynamic loading parameters will assess with dynamic~     pedobarography.~   "
71927|NCT02625467|"~     The purpose of this study is to evaluate the visual results of patients with keratoconus~     treated with one of two techniques: penetrating keratoplasty (PK) vs. pachymetry and Excimer~     laser assisted lamellar keratoplasty (PALK).~   "
71653|NCT02629042|"~     Irreversible pulpitis is an inflammatory condition of the dental pulp, highly painful,~     representing one of the main reasons for consulting dental emergency. The recommended~     emergency care is a partial endodontic treatment under local and/or locoregional anesthesia.~     The purpose of the emergency partial endodontic treatment is to stop the pain of pulpitis by~     removing a portion of the pulp. The final endodontic treatment is ideally performed 72 hours~     after. The literature reports major difficulty in obtaining adequate anesthesia in the~     mandible to perform partial endodontic treatment, especially for the mandibular molars. This~     results in a very painful care for the patient. The management of this type of emergency is~     costly in terms of equipment and time for health facilities. Patient comfort, cost saving and~     rationalization of the care time justify the search for an alternative to emergency partial~     endodontic treatment. In current practice, the short course oral corticotherapy is used in~     the management of oral pain from inflammatory origin. Glucocorticoids, thanks to their~     anti-inflammatory action, can neutralize the inflammatory mediators and thus pain. The pulp~     inflammation can be treated with this molecule: the effectiveness of intraosseous local~     steroid injection for irreversible pulpitis of mandibular molars has already been shown but~     results in local comorbidities and requires specific device. Oral administration of~     short-course prednisolone is simple and safe but its effectiveness to manage pain caused by~     irreversible pulpitis has not yet been demonstrated. Per-os administration of prednisolone~     has a very high (90%) and rapid (≤ 4 hours) bioavailability. No difference in effectiveness~     between intravenous and oral administration of this molecule was reported. This oral~     treatment could limit comorbidities and technical difficulties related to intraosseous~     injection and could delay the endodontic treatment to 72 hours in optimal conditions of~     anesthesia for the patient. Despite the difficulties described for the partial endodontic~     treatment, it is very effective in pain reduction and can reach 100% of success. Therefore a~     non-inferiority design was chosen to compare the effect of a short-course oral corticotherapy~     to a partial endodontic treatment for the reduction of pain at the emergency care of the~     irreversible pulpitis in mandibular molars. The intervention arm will receive an oral dose of~     prednisolone (1 mg/kg) during the emergency visit followed-up by one morning dose by day~     during three days and the reference arm will have partial endodontic treatment. Both groups~     will have planned complete endodontic treatment 72 hours after enrolment.~   "
71654|NCT02629029|"~     Surgical reconstruction of anatomical structures after head and neck cancer resection has~     made enormous strides in the past 20 years with advancing flap techniques and the usage of~     perforating vessels, but accurate and consistent identification of these perforators has~     remained a challenge due to the varying anatomy of vasculature in the donor region. Computed~     tomography angiography (CTA) has been used increasingly in preoperative free flap perforator~     mapping for breast reconstruction but has been limited in head and neck applications. In~     addition, indocyanine green (ICG) assisted NIR fluorescence angiography has been developed~     for intra-operative flap assessment. In this study, the investigators propose to assess a~     previously undocumented, multi-modal imaging technique with preoperative dual energy CTA to~     design and intraoperative ICG assisted NIR angiography to assess free flap in head and neck~     reconstruction.~   "
71655|NCT02629016|"~     This study will evaluate the feasibility of providing an onsite mindfulness intervention,~     delivered as part of the school health curriculum, to help high school-attending adolescents~     cope with stress.~   "
71656|NCT02629003|"~     The purpose of this study is to determine the dosimetry for the Positron Emission Tomography~     (PET) tracer [11C]Cimbi-36 in two different Carbon-11 labelling positions. This information~     will contribute to determining whether [11C]Cimbi-36 can be optimized by changing the C-11~     labelling position.~   "
71657|NCT02628990|"~     The aim is to investigate the effects of yoghurt drinks containing two doses of plant stanol~     ester either with or without added camelina oil on the serum cholesterol levels in moderately~     hypercholesterolemic subjects~   "
71658|NCT02628977|"~     The primary purpose of this study is to ascertain the effectiveness of tailored, peer based~     sleep health education and social support in increasing adherence rates to recommended~     Obstructive Sleep Apnea (OSA) evaluation and treatment among blacks at risk of Obstructive~     Sleep Apnea.~   "
71659|NCT02628964|"~     The purpose of this study is to examine the feasibility of using e-cigarettes as a method for~     harm reduction and the effects of providing e-cigarettes (or placebo e-cigarettes) on smoking~     outcomes. Participants will be randomized to receive either e-cigarettes with nicotine~     cartridges or e-cigarettes with placebo cartridges, and followed for 3 weeks.~   "
71660|NCT02628951|"~     Vascular endothelial growth factor is expressed in gastric cancer, and expression has been~     associated with more aggressive clinical disease. Vascular endothelial growth factor~     expression has been noted in 51% of gastric cancer specimens in one series (versus no~     expression in normal epithelium or superficial gastritis). Vascular endothelial growth factor~     expression in resected gastric cancer is associated with tumor recurrence and shorter~     survival. Maeda et al. studied 95 gastric cancer patients following resection with curative~     intent, and noted a significantly shorter survival in 34 patients whose tumor endothelium~     expressed VEGF (as detected via immunohistochemistry) versus 61 patients without endothelial~     VEGF expression (p<0.05). Yoshikawa and colleagues observed similar survival differences in~     resected gastric cancer patients based on levels of circulating (plasma) VEGF at time of~     resection. Circulating VEGF is significantly higher in gastric cancer patients versus those~     without neoplasia. Elevated circulating VEGF was also associated with shorter survival in a~     European cohort undergoing gastric cancer resection; there was no survival beyond 30 months~     in 24 patients with serum VEGF >533 pg/mL versus a 30-month survival rate >35% for 34~     patients with VEGF levels below this threshold (p<0.0001, log-rank test). Recently, Jüttner~     and colleagues noted reduced survival following R0 resection in gastric cancer patients whose~     tumors expressed VEGF-C or VEGF-D, with the most robust association between expression and~     reduced survival for patients whose tumors expressed both VEGF-C and VEGF-D.~      Investigational inhibition of VEGF Receptor 2 in gastric cancer xenografts (TMK-1 cell line)~     is associated with reduced tumor growth. DC101 therapy in this model is associated with~     significant reductions in tumor vascularity (as measured by CD-31 expression) and increases~     in endothelial and tumor apoptosis.~      The results of the REGARD and RAINBOW studies are consistent with the idea that tumor-~     related angiogenesis contributes to the pathophysiology of gastric cancer and demonstrate the~     ability of ramucirumab to represent an improvement in the care of patients with gastric~     cancer whose disease has progressed after prior chemotherapy.~   "
71661|NCT02628938|"~     The aim of this experiment is to investigate the effect of Miswak on oral malodor and to~     determine whether this effect -if present- is the result of the mechanical action of Miswak~     or the chemical effect of its extract~   "
71662|NCT02628925|"~     Delirium is one of the most common complications among elderly hospitalized patients,~     postoperative patients and patients on intensive care units. The reported prevalence is~     between 11 and 80 %. Delirium is associated with a high morbidity and threefold higher~     6-month mortality. The Nursing-Delirium Screening Scale (Nu-DESC) is a screening tool with a~     high sensitivity and specificity.~      The purpose of this study is to translate the Nu-DESC to danish and evaluate afterwards its~     feasibility and understanding by different medical staff.~      Material and methods:~      The Nu-DESC will be translated after International Society for Pharmacoeconomics and Outcomes~     Research (ISPOR) guidelines to Danish by permission of the original author.~      The evaluation will be performed, by filling out evaluation forms, where the feasibility and~     understanding will be rated on a 6 step Likert scale.~   "
71663|NCT02628912|"~     This study is being done to learn about how the participants lungs and heart are working~     after treatment for throat cancer. The investigators are looking to see if there is a~     long-term impact on overall health from the cancer treatment. The long-term goal of this~     study is to compare the participants overall quality of life to similarly aged people who~     have not had throat cancer.~   "
71664|NCT02628899|"~     To assess the safety and feasibility of Transcatheter Aortic Valve Replacement (TAVR) with~     commercially available bioprostheses in elderly patients with severe, symptomatic aortic~     stenosis (AS) who are low‐risk (STS score ≤3%) for surgical aortic valve replacement (SAVR).~   "
71665|NCT02628886|"~     Streptococcus pneumoniae is responsible for over 10 percent of death in children under five~     and many of these deaths occur in early infancy before the current pneumococcal schedule is~     effective and nearly half occur in sub Saharan Africa.~      The PROPEL trial will examine the effect of either a maternal or a neonatal dose of a~     pneumococcal conjugate vaccine on pneumococcal colonisation in the nose which can be used to~     measure the risk of disease in early life.~      600 Expectant mothers will be randomized at between 28 and 34 weeks to a maternal group, a~     neonatal group or a control group in equal number (200 per group). Their subsequent born~     offspring will be followed up until nine months of age. Infants born from expectant mothers~     in the maternal and control group will receive their subsequent pneumococcal conjugate~     vaccination according to the national Expanded Programme on Immunisation (EPI) schedule in~     the Gambia at 8, 12 and 16 weeks while infants born to expectant mothers in the control group~     will receive the pneumococcal conjugate vaccine within 48 hours of birth and at 8 and 16~     weeks of life. Randomization will be undertaken by defined un-blinded members of the clinical~     trial team who will be delegated for this task and who will not be involved in any other~     trial related procedures Pregnant women who are willing and who are identified by the staff~     of the government antenatal clinic as being potentially eligible according to gestation~     (assessed initially according to the date of the last menstrual period (LMP) - if known, or~     the fundal height), will be referred to a member of the clinical trial team.~      Those who remain interested in participation having had the details of the study explained~     will have basic demographic, obstetric and contact details collected and will be invited, at~     a time of their convenience, to the Medical Research Council (MRC) clinical trial site for~     the formal informed consent process to be completed. Following informed consent, pregnancy~     will be confirmed with a urinary pregnancy test. Initial screening (e.g. for past-obstetric~     history and past-medical history etc) will be undertaken at this point along with screening~     bloods for serology (HIV, hepatitis B and syphilis) and haematology (haemoglobin and sickle~     test). A dating ultrasound scan (USS) will also be undertaken by designated clinical trial~     staff. On completion of screening, expectant mothers who are confirmed to be eligible~     according to the defined inclusion and exclusion criteria will be enrolled and randomized in~     parallel into one of three equally sized groups mentioned above (maternal, neonatal,~     control).~      According to the group into which they have been randomized, mothers will receive a dose of~     PCV13 and tetanus toxoid [maternal group], placebo (0.9% sodium chloride) and tetanus toxoid~     [control group] or tetanus toxoid alone [neonatal group]. From this point on, the maternal~     and control groups (now 'Routine EPI Schedule') will be followed up in exactly the same way~     for the purposes of interventions and all endpoint assessments. Infants in the neonatal group~     ('Neonatal Schedule') will be followed up according to the schedule outlined.~      At the time of presentation to the delivery unit a blood sample for serology and malaria~     Rapid Diagnostic Test (RDT) and an nasopharyngeal swab (NPS) sample will be obtained prior to~     or shortly following delivery. Immediately following delivery a sample of cord blood will be~     obtained and as soon as possible an NPS sample will be taken from the newborn. Anthropometric~     measurements will be taken from the newborn and an examination conducted. Once there has not~     been any contraindication to vaccination identified, all newborns will be administered the~     routine EPI vaccines according to the schedule in The Gambia (BCG, Hepatitis B and OPV).~     Those newborns in the Neonatal group will additionally be administered a single intramuscular~     (IM) dose of PCV13. At two, three and four months, infants will be administered the routine~     EPI vaccines. Those infants in the Maternal and Control Groups (Routine EPI Schedule) will~     additionally receive PCV13 at eight, 12, and 16 weeks while those in the Neonatal group will~     receive the vaccine at eight and 16 weeks only having received the first dose at birth. All~     infants will additionally receive a single dose of the inactivated poliovirus vaccine (IPV)~     at 16 weeks in line with the routine EPI schedule in The Gambia.~      Following the vaccines administered to expectant mothers and following the vaccines~     administered at birth, home visits will be undertaken on day 1 to 6 to collect solicited~     local and systemic adverse (for PCV only) reactions and any unsolicited. A day 7 safety~     clinic visit will be conducted following the vaccines administered to expectant mothers and~     following the vaccines administered at birth. Infant will attend the clinical trial site for~     NPS and blood samples to be taken at specific time points.~   "
71670|NCT02628821|"~     Prospective observational study of SNIPPV use in preterm infants of less than 32weeks of~     gestation from January 2012 to December 2015. Previous respiratory status is analyzed as well~     as respiratory outcomes and possible secondary side effects.~      SNIPPV is used to prevent Intubation in Infants in which nCPAP has already failed (Infants~     that met intubation criteria) and also is used electively for extubation when nCPAP~     extubation has previously failed or infants with Prolonged mechanical ventilation (more than~     15 days) with high respiratory parameters (PMAP > 10 cmH2O and FiO2>35%).~   "
71671|NCT02628808|"~     The main objective of the study is to define, for Autism Spectrum Disorder, the extent of~     genetic variation in synaptic pathways that may be targeted for therapeutic development. For~     this purpose the investigators will take advantage of large, well-characterized cohorts of~     patients with Autism Spectrum Disorder for genetic screenings. Targeted sequencing of~     selected synaptic genes, previously associated with Autism Spectrum Disorder, will be carried~     out in these cohorts with deep coverage of coding regions and a strong focus on previously~     untested regulatory regions. Genomic data from Copy Number Variant, whole genome sequencing~     and exome sequencing, available for some of these patients, will be integrated in the overall~     analysis. The investigators will strongly emphasize the establishment of comprehensive~     genotype/phenotype correlations and set up an induced Pluripotent Stem Cells collection from~     selected patients with synaptic mutations for functional and expression analysis.~   "
71672|NCT02628795|"~     This single-blind, randomized, controlled trial is designed to test the effect of an~     intensive, 16 week exercise rehabilitation program (progressive resistance training +~     functional mobility training) vs. usual care on restoration of muscle mass and mobility after~     total hip (THA) or knee (TKA) arthroplasty in men and women with end-stage osteoarthritis.~     The molecular basis underlying the trial is the presence of significant muscle inflammation~     susceptibility in many of these individuals, and the expectation that the more intensive~     intervention will overcome this inflammatory burden to facilitate recovery.~   "
71673|NCT02628782|"~     The InSeal vascular closure device (VCD) is assessed as percutaneous closure of artery access~     sites for quick hemostasis and ambulation in patients who have undergone large bore~     endovascular catheterization procedures.~      The study hypothesis is that the VCD is safe and efficient in achieving hemostasis in the~     study population.~   "
71674|NCT02628769|"~     This study examines the potential benefit of a new antibiotic, Solithromycin, for the~     long-term treatment of Chronic Obstructive Pulmonary Disease (COPD). Solithromycin is~     hypothesised to work by reducing inflammation in the lungs of patients with COPD. Stable COPD~     patients will receive treatment with solithromycin for 28 days and comparisons will be made~     between any effects observed with Solithromycin and a placebo. This will include any changes~     in inflammatory proteins, lung function and reported symptoms.~   "
71675|NCT02628756|"~     Women between 18-39 years old who had been infertile (primary or secondary) for at least 1~     year were recruited. In a parallel assignment eligible participants were randomized to~     receive either a single, site-specific endometrial injury guided by hysteroscopy (Study~     group) or no intervention (Control group). Natural cycle folliculometry + timed sexual~     intercourse were offered for all participants for the ongoing and the immediate 2 concecutive~     cycles. Clinical pregnancy rates were the primary outcome and miscarriage rates were the~     secondary outcome measures.~   "
71676|NCT02628743|"~     The purpose of this open-label, single arm study is to further evaluate long-term~     tolerability, safety and efficacy outcomes of olesoxime in participants with Spinal Muscular~     Atrophy (SMA) who previously participated in one of the following two clinical studies:~     TRO19622 CL E Q 1115-1 (NCT ID XXX, open-label Phase Ib, multicenter, single- and multiple-~     dose study) or TRO19622 CL E Q 1275-1 (NCT01302600, Phase II/III, adaptive, parallel-group,~     double blind, randomized, placebo-controlled, multicenter, multinational study).~   "
71677|NCT02628730|"~     Atrial fibrillation (AF) is the commonest condition affecting the rhythm of the heart.~     Tablets to try to normalise the heart rhythm rarely work well. As a result, doctors have~     devised a treatment called catheter ablation in which special wires are used to deliver heat~     energy (called ablation lesions) on the inside surface of the heart. Unfortunately, in many~     patients (almost 1 in 2), some of these ablation lesions recover, and this leads to AF~     recurrence. Many of these patients then need a second procedure to deliver further ablation~     at these recovered areas.~      Recent research has shown that monitoring of heat delivery with a factor called Ablation~     Index may be useful in predicting which ablation lesions are less likely to recover.~     Therefore, we aim to carry out AF ablation guided with Ablation Index (AI) and observe~     whether this will be associated with better durability of ablation lesions, and thereby~     better freedom from AF.~      This study will include patients with persistent AF, those whose AF episode(s) last for~     longer than seven days. All patients participating in the study will undergo an initial~     ablation treatment guided by ablation Index . All patients will undergo a repeat procedure~     8-10 weeks after their initial treatment. Any gaps found during the second procedure will be~     closed again by delivery of ablation.~      All participants will be issued with a simple to use handheld heart rhythm monitor, and asked~     to make a 30-second recording of their heart rhythm each day and also whenever they have~     symptoms. The monitor stores these recordings and they will be downloaded at review~     appointments arranged 6 weeks, 3 months, 6 months and 12 months after the initial ablation~     procedure.~   "
71678|NCT02628717|"~     Since the availability of interferon free direct acting antivirals (DAA) the centers~     authorized to prescribed these drugs in Austria submitted their data to a central data base~     (AURIC) using treatment regimes without interferon and ribavirin in patients with advanced~     liver disease (F3/4)~   "
71679|NCT02628704|"~     Double-blind study will compare the efficacy and assess safety of selinexor plus carfilzomib~     (Kyprolis®) plus low-dose dexamethasone versus placebo plus carfilzomib plus low-dose~     dexamethasone in patients with relapsed/refractory multiple myeloma.~   "
71692|NCT02628535|"~     The purpose of this study is to evaluate the safety of MGD009 when given to patients with~     B7-H3-expressing tumors. The study will also evaluate what is the highest dose of MGD009 that~     can be given safely. Assessments will be done to see how the drug acts in the body~     (pharmacokinetics (PK), pharmacodynamics (PD) and to evaluate potential anti-tumor activity~     of MGD009.~   "
85363|NCT02449681|"~     This phase 2 study is designed to evaluate the safety and activity of TH-4000 (Tarloxotinib),~     a hypoxia-activated prodrug in participants with recurrent or metastatic squamous cell~     carcinoma of the head and neck or skin.~   "
71680|NCT02628691|"~     Data on the progression of liver fibrosis in patients co-infected with HIV taking effective~     suppressive antiretroviral therapy with no fibrosis or mild-to-moderate fibrosis at baseline~     are scarce. This uncertainty is reflected in lack of clear guidance on the need for earlier~     (than F3-F4) treatment in co-infected patients.~      Within our hepatitis C/HIV co-infection project in Cambodia, the investigators have the~     opportunity to monitor for short-term fibrosis progression in a cohort of co-infected~     patients with initial no-to-moderate fibrosis being identified during another ongoing study~     (HCV-Epi) and contribute relevant data to aid the risk/benefit analysis of postponing HCV~     treatment in HIV/HCV co-infected patients with initial fibrosis stage F0-F2.~      The HCV-Monitoring study is a mono-centric prospective cohort study proposing a standardized~     follow-up (clinical, biological and imaging) to monitor for progression of hepatitis C~     disease in all patients with HIV infection (on anti-retroviral treatment or not) of Sihanouk~     Hospital Center of Hope (Phnom Penh, Cambodia) who have chronic HCV infection with GT-1, -2,~     -3 or -6 but are not considered in immediate need of HCV treatment.~      All adult HIV-infected patients of the cohort (on ART or not yet on ART) of Sihanouk hospital~     Center of Hope who are identified during the HCV-Epi study having chronic HCV infection (all~     genotypes) and considered not in immediate need of HCV treatment (= Fibrosis stages F0-F2 and~     no clinical signs of extra-hepatic disease) will be considered for inclusion and invited to~     participate.~      Approximately 70 HCV/HIV co-infected patients with no-to-moderate hepatic fibrosis will be~     enrolled in this study.~      Beyond the baseline visit (HCV-Epi), follow-up visits are planned at 6, 12, 18 and 24 months.~     These patient visits will comprise of a history taking and physical examination focused on~     hepatic disease and blood sampling for basic hematologic and hepatic function parameters.~     Additionally, patients will be referred every year for ultrasound and transient elastography~     measurements and sampling for some additional liver function tests and measurement of HCV-RNA~     viral load.~   "
71681|NCT02628678|"~     The primary objective of this study is to determine the 5-day tolerability of one~     commercially available prebiotic food ingredient, FOS, in healthy human subjects with and~     without diet control.~   "
71682|NCT02628665|"~     The therapy of photofrin PDT was effective in improving life quality of patients with~     advanced esophageal and/or gastric cardiac cancer and the time optimizing for employing laser~     irradiation was of great importance.The purpose of this study is to evaluate the clinical~     efficacy and adverse effects of Photodynamic Therapy (PDT) on esophageal and/or gastric~     cardiac cancer during different time after inject photofrin.~   "
71683|NCT02628652|"~     The primary objective of this study is to determine the tolerability of two polyglycan food~     ingredients, GOS and GLOS, at two different levels in healthy human subjects. The comparator~     in this study will be Inulin FOS, a commercially available glycan supplement.~   "
71684|NCT02628639|"~     The purpose of this study is to evaluate whether personalized stimulations can improve the~     detection of electrophysiological signs of awareness in patients with disorders of~     consciousness.~   "
71685|NCT02628626|"~     Compare the effects of a combination of colesevelam and clonidine to placebo on bowel~     symptoms in patients with urge or combined type of FI.~   "
71686|NCT02628613|"~     The purpose of this study is to compare the efficiency and safety between paclitaxel combined~     with carboplatin and vinorelbine combined with epirubicin when used in neoadjuvant~     chemotherapy for locally advanced (IIb-IIIc) HER-2 (-) breast cancer with TEKT4 variation.~   "
71687|NCT02628600|"~     This open-label safety extension study will assess the safety and tolerability of once daily~     dosing of 590 mg Liposomal Amikacin for Inhalation (LAI) added to a multi-drug regimen in~     subjects with non-tuberculous mycobacterium (NTM) lung infections due to Mycobacterium avium~     complex (MAC) who are refractory to therapy in Study INS-212.~   "
71688|NCT02628587|"~     Ischemic heart disease is the leading cause of death and disability in developed countries~     and is responsible for a third of deaths in persons over 35 years . The most severe form of~     ischemic heart disease is sudden death and acute coronary syndrome (ACS).~      There is evidence that early and optimal treatment of ACS decreases mortality. Within the~     optimal treatment, these patients must receive a reperfusion therapy as mechanical or~     pharmacologic treatment. In addition to reperfusion treatment, antiplatelet therapy is a~     central part of the management. Aspirin plus a P2Y12 inhibitor have been shown to decrease~     mortality. In our country, clopidogrel is the more accessible and used P2Y12 inhibitor;~     however, it has been shown to have a wide variability in response and this variability could~     be influenced by different pharmacological, genetic and environmental factors.~      Platelet reactivity measured by aggregometry predicts major cardiovascular events in ACS~     patients treated with clopidogrel. Due to their frequent prescription, generic clopidogrel~     efficacy must be evaluated. The purpose of this study is to compare the platelet reactivity~     in patients with ACS receiving clopidogrel generic versus patent.~   "
71689|NCT02628574|"~     This study will be conducted in 5 parts (Parts A, B, C, D and E).~      Monotherapy Treatment:~      Subjects ≥18 years with advanced solid tumors will be enrolled in the study. Monotherapy dose~     escalation will be performed in Part A. Cycle 1 data from each cohort will be evaluated for~     safety and dose-limiting toxicities (DLTs) prior to dose escalation. Subjects will be~     assigned to a cohort in the order screening is completed. Dose will depend upon the cohort in~     which a patient is enrolled and cohorts will be dosed consecutively by ascending dose. Once~     the maximum tolerated dose (MTD) or maximum administered dose (MAD) has been identified, an~     expanded cohort will be enrolled (Part B).~      Combination Treatment:~      Subjects ≥18 years with advanced solid tumors will be enrolled in the study. Subjects will~     receive TRX518 in combination with gemcitabine (Part C), pembrolizumab (Part D), or nivolumab~     (Part E). Dose escalation will be performed for each part (Part Cesc, Part Desc, Part Eesc)~     and Cycle 1 data from each cohort will be evaluated for safety and dose-limiting toxicities~     (DLTs) prior to dose escalation. Subjects will be assigned to a cohort in the order screening~     is completed. Dose will depend upon the cohort in which a patient is enrolled and cohorts~     will be dosed consecutively by ascending dose. Once the maximum tolerated dose (MTD) or~     maximum administered dose (MAD) has been identified, an expanded cohort will be enrolled~     (Part Cexp, Part Dexp, Part Eexp).~   "
71690|NCT02628561|"~     The purpose is to compare the effects of tDCS and constraint induced movement therapy (CIMT)~     in the premotor cortex vs. primary motor cortex in severely subacute stroke survivors.~   "
71691|NCT02628548|"~     Normal aging is associated with gradual cognitive declines. These mild neurocognitive~     disturbances affect daily functioning, health status, and quality of life, and likely account~     for the roughly $2.9 billion lost by the elderly each year to fraud. The goal of this project~     is to compare two different 8-week training programs to promote successful neural and~     cognitive aging. Changes in neural structure and cognitive function will be assessed in a~     cohort of older adults, as well as the long-term stability of these changes over 24 months.~   "
72450|NCT02618642|"~     Plotting i/t curve before a series of phototherapy treatments and after their completion.~     Pain threshold assessment with algometer. i/t curve. Creation of 3 test groups: 1 - Piler~     light + red filter, 2 - Piler light + blue filter, 3 - Piler light without a filter. Creation~     of a numerical coefficient for i/t curve.~   "
71693|NCT02628522|"~     Investigators performed a prospective pilot study to test the feasibility and safety of~     autologous adipose derived regenerative cell (ADRC) transplantation in treatment of anal~     fissures. The study included 6 patients with chronic anal fissures with symptoms that had an~     average duration of 24 months. All patients were candidates for surgical treatment as all~     previous conservative treatments were unsuccessful. The pain level was measured using the VAS~     scale and was recorded before the treatment and on every consultation following the~     treatment.~      The initial hypothesis is that application of ADRCs may be an alternative to lateral~     sphincterotomy and a reliable procedure to avoid fecal incontinence.~   "
71694|NCT02628509|"~     The WITAVI study was designed to explore the kinetic and associated outcome of Von Willebrand~     Factor-multimerizaton defects associated with devices in cardiovascular diseases.~   "
71695|NCT02628496|"~     The purpose of this study is to evaluate the accuracy and efficacy of using confocal laser~     microlaryngoscopy (CLM) as a tool to perform non-invasive, in vivo, real time pathologic~     assessment of laryngeal lesions.~      In order to achieve this purpose, this study will prospectively enroll patients with clinical~     evident laryngeal pathology concerning for cancer or dysplasia, who are scheduled to undergo~     a formal intraoperative biopsy of their lesion. While in the operating room, prior to~     performing a formal biopsy, CLM will be used to evaluate the area of pathology, surrounding~     tissue, and contralateral normal tissue. Then the biopsy will be performed, as per standard~     protocol, and the diagnostic results from CLM and the formal biopsy will be compared.~   "
71696|NCT02628483|"~     The health benefits of omega-3 fatty acids have been extensively examined in many published~     studies, and these benefits have been observed in patients with a diversity of conditions and~     diseases, including cardiovascular disease (e.g. atrial fibrillation, atherosclerosis,~     thrombosis, inflammation, sudden cardiac death, etc.), age-related cognitive decline,~     periodontal disease, rheumatoid arthritis, etc. These fatty acids may also be beneficial to~     healthy individuals, in terms of preventative health benefits. The balance between omega-6~     long chain fatty acids and their omega-3 counterparts is important in health maintenance. An~     omega-6:omega-3 ratio of 1:1 or 2:1 is recommended for optimal health, yet the average ratio~     in the North American population is estimated to be as much as 10:1 or even 20:1. A 2014~     study of the dietary habits of U.S. adults revealed that, in general, North Americans do not~     meet the recommended omega-3 fatty acid intake from foods alone. Supplementation may need to~     be considered, in order to help this population meet their daily needs. Both the Academy of~     Nutrition and Dietetics and the American Heart Association suggest a prudent approach in~     recommending an increased intake of omega-3 fatty acids. Although both organisations~     recommend a preference for obtaining omega-3 fatty acids through fish consumption, both also~     recognise that supplementation may also be required in order to meet target values,~     particularly in at-risk populations.~      Several omega-3 fish oil supplements exist on the market each with their own ratios of EPA~     and DHA and are available in varying forms including ethyl ester and high triglyceride forms.~     Differences in product formulation have been shown to have varying health effects.~   "
71697|NCT02628470|"~     Currently, there are many studies about the effects of manual therapy on pain, but there are~     not enough studies to know what are the mechanisms that cause these effects.~      Although there is a research measuring neuromodulators substances after a cervical and dorsal~     manipulation, it has been done in healthy subjects and there is no information about~     mobilization. This work aims to select a sample with chronic neck pain, incorporating the~     cervical mobilization as a therapeutic approach to compare the effects of both techniques~     because not all patients accept the manipulation as a treatment technique (mobilization is~     much better tolerated) and to verify that the liberation of cortisol is not just caused by~     the stress on the joint manipulation and the psychological stress and expectation may be~     important.~      The hypothesis of this paper is that cervical manipulation and mobilization in subjects with~     chronic neck pain there will increase salivary cortisol levels.~      It is also expected a little increase in the expectation of being manipulated group because~     of the psychological stress.~      It is expected an improvement in the neck disability, pain and range of motion in the~     intervention groups immediately after and in the three groups the following week after the~     exercise.~      The main objective of the study is to measure and analyze changes in salivary cortisol~     concentrations after the intervention in the three groups. Secondary objectives is to analyze~     the changes in range of motion and disability caused by neck pain neck pain level~   "
71698|NCT02628457|"~     There are two purpose of this study, first is to find whether arthroscopic rotator cuff~     repair is changing the appearance of supraspinatus muscle atrophy in each and every patient.~     Second, is to find how much approximate change one can expect depending on age and tendon~     retraction~   "
71699|NCT02628444|"~     The aim of the study is to assess the safety of the primary series vaccine schedules and the~     booster vaccination~      Primary Objectives:~        -  To demonstrate the non-inferiority of the immune response elicited against each dengue~          serotype by tetravalent CYD vaccine given as a 2 dose schedule (Placebo 1/CYD Dengue~          vaccine group) compared to the immune response elicited by CYD vaccine given as a 3 dose~          schedule (CYD Dengue vaccine group) 28 days post-final vaccination.~        -  To demonstrate the non-inferiority of the immune response elicited against each dengue~          serotype by tetravalent CYD vaccine given as a 1 dose schedule (Placebo 2/CYD Dengue~          vaccine group) compared to the immune response elicited by CYD vaccine given as a 3 dose~          schedule (CYD Dengue vaccine group) 28 days post final vaccination.~        -  To demonstrate the non-inferiority of the immune response elicited against each dengue~          serotype 28 days after administration of a single booster dose of tetravalent CYD~          vaccine~      Secondary Objectives:~        -  To demonstrate the superiority of the immune response elicited by tetravalent CYD~          vaccine given as a 2 dose schedule (Placebo 1/CYD Dengue vaccine group) compared to the~          immune response elicited by CYD vaccine given as a 3 dose schedule (CYD Dengue vaccine~          group) 28 days post-final vaccination.~        -  To demonstrate the superiority of the immune response elicited by tetravalent CYD~          vaccine given as a 1 dose schedule (Placebo 2/CYD Dengue vaccine group) compared to the~          immune response elicited by CYD vaccine given as a 3 dose schedule (CYD Dengue vaccine~          group) 28 days post-final vaccination.~        -  To describe the neutralizing antibody levels of each dengue serotype at 28 days post~          Dose 3 to the Ab levels immediately before receiving booster injection in all 3 CYD~          vaccination groups.~        -  To describe the neutralizing antibody levels of each dengue serotype at 28 days~          post-dose 2 and 28 days post-dose 3 from CYD Dengue vaccine group in a primary series~          schedule.~        -  To demonstrate the superiority of the immune response elicited against each dengue~          serotype 28 days after administration of a single booster dose of tetravalent CYD~          vaccine.~        -  To evaluate the safety profile of CYD vaccine after each and any injection~   "
71700|NCT02628431|"~     The elfitor device is a small non invasive device that uses dynamic light scattering to~     measure skin bloodflow, blood velocity, coagulation and hemodynamic parameters. In this~     study, the investigators will investigate whether the elfitor device is able to detect~     changes in bloodpressure, cardiac output during general anesthesia. Furthermore, the~     investigators will investigate changes in cutanuous blood flow in different parts of the body~     during peripheral nerve or neuraxial block.Being able to monitor these entities, under- and~     overdosing of general and local anesthetics may be prevented, resulting in favorable~     hemodynamics and better intra and postoperative pain relieve.~   "
71733|NCT02628002|"~     This study will test the hypothesis that the anti-gravity treadmill can be safely used in~     stress nuclear myocardial perfusion imaging in patients unable to perform conventional~     treadmill exercise.~      This will be foundational evidence on which to consider a larger clinical trial to show that~     the anti-gravity treadmill improves diagnostic specificity across all cardiovascular stress~     testing modalities including treadmill-alone, exercise stress echocardiogram, exercise SPECT~     as well as having implications for cardiac PET and MRI in the future.~   "
71701|NCT02628418|"~     Hand recovery following cerebral stroke is complex and requires intensive training. The~     investigators aimed to evaluate the feasibility and efficacy of robot-assisted hand~     rehabilitation compared to physiotherapist-guided treatment in recovering dexterity and hand~     strength in hospitalized sub-acute hemiplegic patients. Design. 30 patients affected by~     stroke from cerebral ischemia or hemorrhage (Ashworth spasticity index <3) were randomized.~     Patients in the Treatment group received intensive hand training with Gloreha, a hand~     rehabilitation glove that provides computer-controlled, repetitive, passive mobilization of~     the fingers, with multisensory feedback. Patients in the Control group received conventional~     intensive hand rehabilitation under physiotherapist guidance. Hand motor function (Motricity~     Index, MI), fine manual dexterity (Nine Hole Peg Test, NHPT) and strength (Grip and Pinch~     test) were measured at baseline and after rehabilitation, and the differences between final~     and basal results were compared between groups.~   "
71702|NCT02628405|"~     This phase I/II trial studies the side effects and best dose of lenalidomide when given~     together with rituximab-ifosfamide-carboplatin-etoposide (R-ICE) and to see how well they~     work in treating patients with diffuse large B-cell lymphoma that has returned after a period~     of improvement and that has not responded to previous treatment. Drugs used in chemotherapy,~     such as rituximab, ifosfamide, carboplatin, etoposide, and lenalidomide, work in different~     ways to stop the growth of cancer cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Giving lenalidomide with R-ICE may be a better~     treatment for patients with diffuse large B-cell lymphoma.~   "
71703|NCT02628392|"~     The objectives of the study is to evaluate the efficacy, safety, and dose of DS-8500a~     compared with placebo in patients with type 2 diabetes mellitus.~   "
71704|NCT02628379|"~     The goal of the current study is to determine whether Foundation Medicine's next generation~     sequencing assay, called FoundationOne, will provide information that allows physicians to~     make treatment decisions using targeted therapies in clinical trials or FDA approved~     therapies, including off-label agents, that result in superior OS compared to historical~     outcomes for standard CUP therapy.~   "
71705|NCT02628366|"~     People with failed kidneys need an artificial kidney machine (called dialysis) to remove~     toxins and extra fluid from the body. Most patients receive dialysis treatments at a hospital~     three times a week. During treatment, a patient's blood pressure may drop, causing dizziness~     and muscle cramping. Repeated drops in blood pressure can also injure the heart and brain.~     Over time, this can lead to heart attacks, strokes, and sometimes death. New research shows~     that cooling the temperature of the dialysis fluid (called dialysate) can reduce heart and~     brain injury. In most hospitals, all patients' dialysate temperature is set at 36.5 ºC (to~     match body temperature). In our study of 73 patients, we showed that reducing the dialysate~     temperature to 0.5 ºC below body temperature protected the heart and brain from injury [1,2].~     We now want to test this simple, safe, low-cost intervention in a large study with more than~     7000 dialysis patients in Ontario. We can lower the dialysate temperature on dialysis~     machines in Ontario at no added cost. This intervention has the potential to reduce many~     hospitalizations and deaths in Ontario, and relieve suffering in patients with kidney~     failure.~   "
71706|NCT02628353|"~     The study's main objective is to investigate the effects of acute consumption of a~     preparation containing 100 mg of a specific phenolic compound (patent pending, P201531587) on~     systolic BP after ingestion of a high fat meal.~   "
71707|NCT02628340|"~     HIV infection can be efficiently controlled by antiretroviral therapy (ART), with in 2013~     nearly 85 % of patients having a suppressed viremia, but HIV cannot, however, be eradicated~     with ART alone [1]. Overall, HIV has moved from a fatal to a chronic disease provided~     treatment is maintained life-long. Despite major improvement in antiretroviral drugs in terms~     of efficacy, tolerability and simplicity, life-long therapy is still associated with drug~     toxicity. Several drugs or drug classes, which have historically saved lives since 1996 and~     are currently widely used such as protease inhibitors and nucleosides analogues, are~     associated with long-term toxicities and increased incidence of comorbidities.~      Currently, worldwide there is an approximated 10 millions of HIV infected patients under~     cART. This number should increase in the next years, as most recent guidelines recommend~     earlier therapy given the benefits in terms of disease progression and prevention of~     transmission. Because of the increasing number of patients who will be under cART in the~     future, the cumulative ART toxicity, the difficulties to access ART in some areas of the~     world, the fatigue expressed by patients about ART and the cost issues, there is an urgent~     need to search for HIV CURE. To date, only two cases of sterilizing HIV cure were reported so~     far: the famous Berlin Patient after two homozygous Delta32-CCR5 bone-marrow grafts for an~     acute leukemia [2], and the Mississipi baby after very early initiation of cART 31 hours~     after delivery [3]. However those cases of sterilizing HIV cure remain exceptional and the~     alternative objective of a functional HIV cure appears to be more realistic, though still~     described in rare groups of patients like Elite controllers (EC) and post treatment~     controllers (PTC) patients. In addition new and complex therapeutic strategies are currently~     proposed to try purging the HIV reservoirs, but none of them proved so far able to reach this~     goal.~      Therefore the objective of finding a Cure to HIV [4] requires first to better understand the~     basic mechanisms of the persistence of HIV reservoirs in the population of~     chronically-infected fully-suppressed HIV+ patients in order to define future therapeutic~     strategies.~   "
71708|NCT02628327|"~     1. To administer a questionnaire to patients seen by Wills Eye Glaucoma Department~          physicians at Wills Eye Hospital assessing satisfaction with their office visit, vision~          related quality of life, and related issues.~        2. To collect and de-identify information from each participant's medical chart related to~          their care including information pertaining to demographics, disease severity, and prior~          and current treatment~        3. To assess the correlations between demographic factors, vision related quality of life,~          eye disease, and treatments with patient satisfaction survey responses.~   "
71709|NCT02628314|"~     The purpose of this research study is to test whether researchers can reliably measure the~     response pupils have when an acute painful stimulus is experienced. Changes in the size of~     the pupil of the eye can be an indicator of brain activity in a region of the brain that is~     important for feeling pain.~   "
71710|NCT02628301|"~     This study aims to elucidate the role of the microcirculation in the development of whole~     body insulin resistance. The investigators hypothesize that impaired insulin signaling in the~     vasculature is an early phenomenon in the development of whole body insulin resistance.~     Furthermore, the investigators aim to identify improvement of microvascular function as a~     potential target in diabetes prevention and treatment.~   "
71711|NCT02628288|"~     Comparison of healing responses after treatment of complex bifurcation lesions with a~     dedicated bifurcation device (Axxess™ Biolimus Eluting Coronary Bifurcation Stent System +~     Absorb BVS in the distal branches) versus the Modified T stenting technique using Absorb BVS:~     an optical coherence tomography (OCT) analysis.~   "
71712|NCT02628275|"~     Subclinical atherosclerosis is identified in roughly 2/3rd of otherwise healthy young adults.~     How much physical activity is required to prevent progression of subclinical atherosclerosis?~     In the 85% of healthy younger Canadian men and women who do NOT perform the recommended 150~     min/week of moderate- to vigorous-intensity physical activity (MVPA) as recommended, is it~     reasonable to aim for a lower regimen of light physical activity (LPA) despite the absence of~     supporting literature, or to the contrary should the investigators insist on achieving MVPA?~     In this perspective, MoMA provides a unique opportunity to determine whether LPA vs. MVPA is~     necessary to limit subclinical atherosclerosis progression in inactive otherwise healthy~     adults. Resolving such unknowns should inform strategies to prevent decades of silent disease~     progression leading to future morbidity and mortality.~   "
71713|NCT02628262|"~     Funds autofluorescence (FAF) indicates hyper fluorescence at the macular hole in the patients~     with macular hole. Investigators investigate the association between FAF and visual acuity,~     recovery of foveal microstructure, and FAF in surgically closed macular holes.~   "
71714|NCT02628249|"~     Protein requirements in individuals who participate in endurance-based exercise training have~     been suggested to be greater than the current recommended dietary allowance (RDA).~      The biological value of protein depends on the amino acid composition. As liebig's law of the~     minimum, the protein synthesis is limited due to the lack of single rate limiting amino acid.~     In this case, the first rate limiting amino acid determines protein intakes to maximize the~     protein synthesis. Adding a small amount of rate-limiting amino acid to the diet improves the~     biological value of its protein diet.~      The indicator amino acid oxidation (IAAO) method has clarified the individual amino acid~     requirement in children, normal healthy adult and clinical populations. however, the IAAO~     method has never been utilized for determining the first rate limiting amino acid.~      Therefore, the purpose of this study is to address of IAAO method to be applied for~     determining the rate-limiting amino acid in endurance athlete.~   "
71715|NCT02628236|"~     The purpose of this study is to evaluate the potential for systemic exposure of~     aminolevulinic acid (ALA) and protoporphyrin IX (PpIX) when applied topically under~     occlusion, in a maximal use setting in patients with multiple actinic keratoses (AK)~     involving the upper extremities.~   "
71716|NCT02628223|"~     Selective laser trabeculoplasty (SLT) is a well-recognized way to lower eye pressure in~     treatment of glaucoma. This treatment is performed for 180 degrees or 360 degrees, and~     studies at academic centers have shown mixed results when comparing the success rates of 180~     degrees or 360 degrees. Both protocols are now typically done by comprehensive~     ophthalmologists. However, there is no data that compares success rates of 180 degrees and~     360 degrees in the community setting.~   "
71717|NCT02628210|"~     This is a single-arm post-market study in patients requiring lumbar fusion using allograft~     interbody spacer in conjunction with map3® Cellular Allogeneic Bone Graft in patients with~     degenerative disc disease (DDD). This cohort study will enroll 80 patients total at up to 10~     sites. After subjects have signed an informed consent, the baseline visit and examinations~     will be completed. Patients will be evaluated at 6 weeks, 3 months, 6 months, 12 months, and~     24 month visit after surgery.~   "
71718|NCT02628197|"~     The purpose of this interventional study was to investigate the impact of control of systemic~     inflammation by scaling and root planing (SRP) on bone mineral density (BMD) in osteopenic~     post-menopausal women with Chronic periodontitis(CP). Out of 68 osteopenic postmenopausal~     women with CP, 34 participants each were included in test and control group. BMD, hsCRP and~     periodontal parameters were recorded at baseline and 6 months.~   "
71719|NCT02628184|"~     BACKGROUND: In 2011 a Maternity Services Development Programme was implemented in a South of~     England city, to promote effective collaborative working between maternity services~     (midwives) and other service providers (health visitors, social workers, specialist services~     etc.) by co-locating services in local childrens centres. The progamme ultimately aimed to~     improve care for local service users (women and their families), especially those considered~     vulnerable. Implemented changes were based on evidence that suggests poor collaborative~     working contributes to poorer outcomes. RATIONALE: To explore the impact of the programme on~     local service providers, and by association service user care. AIM: To explore a localised~     Maternity Services Development Programme, identifying how inter- agency collaborative working~     occurs, and the service providers perceived benefits and challenges on collaboration, and by~     association service user care. METHODOLOGY: The proposed research uses a case study approach~     to collect and analyse predominantly qualitative data, and some quantitative data. Data will~     be collected using observation episodes (e.g. participant meetings) to observe collaboration,~     and interviews to explore these experiences. Additionally documents will be analysed to~     observe documented evidence of collaborative practice. Pre-existing statistical data will~     also be used to highlight changes in indicators of service user well being since the~     implementation of the Maternity Services Development Programme. PARTICIPANTS: A cross-section~     of service providers (no service users) working in or with maternity services from 4 of 9~     city Children Centre's. FINDINGS: No current findings, data collection expected to start~     September 2015.~   "
71720|NCT02628171|"~     This study evaluates the effect of cashew nut consumption on traditional and emerging markers~     of cardiovascular disease (CVD) risk and determines the usable energy content of a serving of~     cashew nuts for accurate food labelling.~   "
71721|NCT02628158|"~     Fundus autofluorescence (FAF) at the macula originates from hyperfluorescence from retinal~     pigment epithelium (RPE) and blockage of hyperfluorescence by macular pigment. Investigators~     evaluate whether presence of FAF may correlate to the postoperative visual outcome for~     epiretinal membrane.~   "
71722|NCT02628145|"~     This is a randomized clinical trial with a control group that will test how periodized~     resistance training will impact measures of sarcopenia in older women who have been~     identified as presarcopenic or sarcopenic. The intervention will be approximately 12 weeks in~     duration with 24 total free-living older women. Outcome measures will be collected at~     baseline, 6 weeks and post-intervention.~   "
71734|NCT02627989|"~     This study intends to investigate patient satisfaction of treatment with Ointment (W/O~     emulsion) formulations of Potency Class II topical corticosteroids (TCs) for atopic~     dermatitis (AD) patients in Japan. Objectives include measuring patient satisfaction,~     treatment adherence, itchiness, and AD severity scores.~   "
71723|NCT02628132|"~     The expression of PD-L1 in breast cancer has been previously demonstrated (Ghebeh et al~     2006). In addition, PD-L1 has been shown to work as a molecular shield, by protecting~     cancer cells from cytotoxic T-cells and chemotherapy induced apoptosis (Ghebeh et al 2008)~     suggesting to combine PD-L1 blockade with chemotherapy.~      This trial will test Durvalumab in combination with Paclitaxel on metastatic triple-negative~     breast cancer patients. The safety profile of Durvalumab as a monotherapy has been previously~     established (lu et al 2015). In this trial the safety profile and tolerability of Durvalumab~     given in combination of Paclitaxel will be tested. In addition, the efficacy of this~     combination on metastatic breast cancer will be monitored.~   "
71724|NCT02628119|"~     Hemodialysis (HD) vascular access dysfunction is a huge clinical problem which results in~     significant clinical morbidity in patients with End Stage Renal Disease (ESRD), causing a~     severe economic burden on any health care system. Arteriovenous (A-V) dialysis accesses are~     the preferred form of permanent dialysis access as compared to central venous catheters (CVC)~     . One of the reasons for CVC use is poor long term patency rates of A-V access. Arteriovenous~     Grafts (AVG) have a primary patency rates of just under 50% at 12 months and around 33% at 18~     months. Native arteriovenous fistula (AVF) are slightly better with primary patency rates of~     around 60 percent at one year and 51 percent at 2 years. The most common cause for AVF and~     AVG dysfunction is stenosis development due to neointimal hyperplasia (NIH) within the~     circuit leading to access thrombosis. Percutaneous transluminal angioplasty (PTA) is the~     current standard of treatment for these lesions. Despite being the treatment of choice for~     these lesions patency rates after PTA continue to be dismal. One of the problems with poor~     long term outcomes after successful intervention is how you assess immediate intervention~     success. Successful angioplasty is defined by Dialysis Outcome Quality Initiative (DOQI)~     guidelines as one where only less than 30% residual stenosis remains at the end of~     intervention. Unfortunately angiographic images post angioplasty correlate poorly with~     improvement of access flows through the arteriovenous circuit. There are two main problems~     with these practice standards. First, they are based on a 2-dimensional angiographic view of~     the lesion which may be misleading. Secondly, this assessment of recoil is very subjective~     and not base on objective data.~      Access flow monitoring can now be performed intra-procedurally with thermal dilution~     technique. Its benefit was shown in a small pilot study. To date there have not been any~     randomized controlled trials to assess the benefit of such an approach where intervention is~     based on improvements in access flow at the time of intervention. We hypothesize that such an~     approach will improve outcomes after interventions related to access dysfunction. This may~     also identify the right scenarios in which stent placement may benefit thus improving~     outcomes after stent placement as well.~   "
71725|NCT02628106|"~     The purpose of this study is to evaluate the effect of lipo-prostaglandin E1 （lipo-PGE1) on~     renal oxygenation in patients with diabetic nephropathy by blood oxygenation level dependent~     magnetic resonance imaging (BOLD-MRI).patients with stable chronic kidney disease (CKD) were~     included. All patients were divided into two groups: diabetic nephropathy（DN) and CKD without~     diabetes. In addition to the conventional treatments, all patients received 10 ug lipo-PGE1~     intravenously once daily for consecutive 14 days. Kidney BOLD-MRI were performed before and~     after lipo-PGE1 administration to acquire bilateral renal cortical R2*(CR2*) and medullary~     R2* (MR2*) values. Meanwhile, the clinical indexes at baseline and under lipo-PGE1 including~     24 hours urinary protein and serum creatinine were collected. the investigators want to prove~     Lipo-PGE1 can improve kidney medullary oxygenation in patients with DN.~   "
71726|NCT02628093|"~     Prospective randomized controlled study, at Colon and Rectal Surgery, WMC/NYPH. Subjects~     undergoing Laparoscopic Left Colectomy will be randomized into 1 of 2 groups based on the~     instrument used for tissue dissection and vessel ligation: Group 1 - THUNDERBEAT Group 2~      - Ligasure Population~   "
71727|NCT02628080|"~     Solid tumours often have highly disorganised vasculature that results in low oxygenation.~     This combined with high metabolic rates leads to oxygen demand outstripping supply causing~     tumour hypoxia. Hypoxia drives multiple cellular processes involved in the hallmarks of~     cancer. Tumour hypoxia also decreases the effectiveness of anticancer treatments. This is~     especially true for patients treated with radiotherapy since it has been long recognised that~     hypoxic tumour cells require 3 times the dose of radiation to cause the same amount of cell~     death as cells irradiated under normal oxygen conditions.~      To date, the majority of attempts at overcoming tumour hypoxia have focused on increasing~     oxygen supply. However, such techniques have produced modest benefits at best and~     subsequently have not been adopted into current clinical practice.~      An interesting alternative approach to tackling tumour hypoxia is to decrease oxygen 'demand'~     by reducing tumour oxygen consumption. This strategy has been suggested to be more effective~     in reducing hypoxia than previous methods aimed at increasing oxygen delivery.~      Pre-clinical data demonstrates that the commonly prescribed anti-protozoal drug atovaquone~     significantly reduces oxygen consumption in a variety of tumour cell lines in vitro. This~     reduction in oxygen consumption leads to a profound reduction in tumour hypoxia in animal~     models. It is anticipated that if these effects on tumour hypoxia could be reproduced in~     humans, that their tumours could be rendered markedly more sensitive to radiotherapy.~      This window of opportunity trial will assess whether atovaquone significantly reduces tumour~     hypoxia in adult patients referred for surgery with suspected non-small cell lung cancer.~     This will be assessed using a combination of functional imaging and circulating markers of~     hypoxia. If atovaquone is demonstrated to result in a reduction in tumour hypoxia, larger~     clinical trials will be conducted to determine whether this well-tolerated and inexpensive~     agent improves radiotherapy efficacy and clinical outcomes.~   "
71728|NCT02628067|"~     In this study, participants with multiple types of advanced (unresectable and/or metastatic)~     solid tumors that have progressed on standard of care therapy will be treated with~     pembrolizumab.~   "
71729|NCT02628054|"~     Research studies have found a relationship between the immune system (how the body reacts to~     an infection) and the development of depression. As it is still unclear how they might be~     linked the investigators will use a typhoid vaccination to activate the body's immune system~     and will measure the response by looking at changes in sleep patterns.~   "
71730|NCT02628041|"~     High-dose rate brachytherapy (HDRB) used as monotherapy is emerging as an alternative to~     Low-Dose Rate brachytherapy (LDRB) with excellent PSA-progression free survival as high as~     90-100% for favorable prostate cancer at a median follow-up of 3-5 years.~      HDRB has many advantages over LDRB such as prospective dosimetry not impacted by setup~     errors, organ motion and prostate swelling during treatment delivery. In addition, HDRB~     causes less acute and late urinary toxicity compared with LDRB. Acute urinary retention can~     lead to prolonged catheterization, pericatheter urine leakage, urinary tract infection and~     Trans-Urethral Resection of the Prostate resulting in diminished quality of life (QOL) and~     increased psychological distress.~      The goal of the investigators' phase II randomized study is to evaluate the differences in~     QOL in the urinary domain between patients with favourable intermediate risk or extensive~     low-risk prostate cancer treated with LDRB and HDRB at 3 months using the Expanded Prostate~     Cancer Index Composite (EPIC) QOL scores. The 3 months cut-off endpoint has been chosen since~     HDRB-induced urinary toxicity subsides at 12 weeks compared to 12 months with LDRB. Secondary~     objectives include: bowel and sexual domain EPIC scores and International Prostate Symptom~     Score. The absolute PSA nadir and a prostate biopsy at 36 months will be reported to assess~     local control.~   "
71731|NCT02628028|"~     The main purpose of this study is to evaluate the safety and effectiveness of LY3337641 in~     adults with rheumatoid arthritis (RA).~   "
71732|NCT02628015|"~     This study tests preschoolers, school children, youths and young adults, who were born~     preterm or full-term, in their theory of mind abilities.~   "
71735|NCT02627976|"~     A common complication of breast conserving therapy is breast edema, which may lead to chronic~     pain, but also reduced quality of life (QoL) and poor cosmetic outcome. When pain is present~     most patients are currently treated with physical therapy, but evidence of its effectiveness~     is still low and a gold standard does not yet exist. A downside of physical therapy is that~     patients have to undergo the therapy regularly and treatment might even has to continue for~     years after symptoms and treatment started. Another treatment option is a compression vest~     with the potential, apart from reducing symptoms, to improve self-efficacy in patients~     because they decide when to wear it without the need to visit therapists. However~     effectiveness of the compression vest has not yet been objectified in studies.~      The aim of this pilot study is to study if there is an effect on pain, QoL and the amount of~     breast edema of wearing a compression vest, in order to determine whether a large randomized~     study is feasible.~   "
71736|NCT02627963|"~     This is a Phase 3, open-label, randomized, controlled, multi-national, multi-center,~     parallel-arm study comparing tivozanib to sorafenib in subjects with refractory advanced~     renal cell carcinoma (RCC).~      Subjects will be randomized (1:1) to treatment with tivozanib or sorafenib.~      Subjects will be stratified by International Metastatic Renal Cell Carcinoma Database~     Consortium (IMDC) risk category (favorable; intermediate; poor) and prior therapy (two prior~     vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR TKI); a prior~     checkpoint inhibitor [programmed cell death -1 protein (PD-1) or PD-1 ligand (PD1-L)~     inhibitor] plus a prior VEGFR TKI; a prior VEGFR TKI plus any other systemic agent).~      All subjects will be evaluated for progression free survival, overall survival, objective~     response rate, and the duration of response as well as safety and tolerability.~      Pharmacokinetic (PK) analysis are also included in study.~   "
71737|NCT02627950|"~     The current prospective, randomized, controlled MonAMI trial aims to systematically examine~     the effects of morphine on the platelet inhibitory effects of the orally administered~     platelet inhibitor ticagrelor in patients with acute myocardial infarction. In addition, the~     potential positive or negative effects of MCP in combination with morphine on platelet~     inhibition will be studied.~   "
71738|NCT02627937|"~     The purpose of this study is to develop adequate and satisfactory tools using reliable~     clinical and physical factors in predicting pediatric obstructive sleep apnea/hypopnea~     syndrome (OSAHS) and allow greater access to appropriate therapy in children.~   "
71739|NCT02627924|"~     The study is designed as a prospective, observational study to assess the effect of~     adalimumab on health-related quality of life (QoL) and work productivity in patients with~     rheumatoid arthritis (RA) in Korea~   "
71740|NCT02627911|"~     The study will be conducted in crossover trial, with two 72-hour hospitalization separated by~     a period Wash-out of at least one week. Each hospitalization is a period of treatment.~     According to randomization, patients will be provided with either Diabeloop system or the~     usual system.~      In both treatment periods:~        -  patients in a situation of sedentarity or physical activity, will be equipped with~          ActiGraph (measuring motricity) and a ActiHeart ( measuring heart rate)~        -  meals and physical activities will be similar in both periods~        -  the same blood glucose meter will be used throughout the duration of the study.~        -  the capillary blood glucose will be performed : before bolus and 2 hours after a meal,~          before exercise, in case of hypo or hyper-glycemic episodes and when the patient and /~          or investigator deem it necessary.~   "
71741|NCT02627898|"~     Type 2 diabetes mellitus (T2DM) has become the epidemic of the XXI century. This chronic~     disease is also highly prevalent and primarily associated with an increased cardiovascular~     mortality and morbidity due to micro and macrovascular complications, where its~     pathophysiological mechanism accelerates the formation of the atherosclerotic process,~     fundamental element associated with arterial stiffness. The importance of anticipating the~     presence of a cardiovascular event lies precisely in the early detection of subclinical~     changes in the elastic arteries identified by measuring the pulse wave velocity. Having~     adequate pharmacological or non-pharmacological interventions that impact precisely in the~     reduction of pulse wave velocity contributes to a reduction of cardiovascular morbidity and~     mortality associated with DM2. Among non-pharmacological therapies they have been studied the~     benefits attributed to the use of green tea infusion either encapsulated or extract have been~     associated mainly with anti-inflammatory and antioxidant effects. There are both experimental~     and clinical studies that have shown benefits of administration of green tea (extract or~     infusion), and administered by different routes at different dosages and for varying times.~     But it has been noted that not all studies with green tea meet appropriate to draw~     conclusions about its benefits to cardiovascular level. However, it is proposed that the use~     of green tea extract with a highest amount of catechins through a controlled clinical trial~     could be a potential therapeutic strategy for changing hemodynamic alterations and arterial~     stiffness favorably in this particular group of patients DM2.~   "
71742|NCT02627885|"~     The aim of the study is to investigate if an Internet-based psychological treatment based on~     principles from Cognitive Behavioral Therapy can increase function and quality of life for~     patients with Parkinson disease.~   "
71743|NCT02627872|"~     Chronic Obstructive Pulmonary Disease (COPD) is an increasing global health problem, which~     primarily increases among the female population. The purpose of this study is to perform~     in-depth clinical and molecular characterizations of early stage COPD patients, as well as~     healthy never-smoker and at-risk smoking control populations to identify molecularly related~     subgroups patients, including gender-related sub-phenotypes of COPD.~   "
71744|NCT02627859|"~     26 week open label study of treatment with Durolane for OA pain of the ankle~   "
71745|NCT02627846|"~     A randomised clinical trial comparing endovenous laser ablation and mechanochemical ablation~     (ClariVein®) in the management of superficial venous insufficiency.~   "
71746|NCT02627833|"~     Bronchiolitis obliterans is a chronic disease in which a persistent inflammatory process~     leads to obliteration of the small airways. Pulmonary function tests (body plethysmography~     with DLCO, lung clearance index) are performed and the fraction of exhaled nitric oxide is~     measured. A blood test is following to determine the inflammatory status und collect miRNA.~     Induced Sputum will be obtained.~   "
72451|NCT02618629|"~     The aim of this Phase I study is to determine the absorption, metabolism, and excretion of~     14C-Z-215 in healthy male subjects following a single oral administration at a~     therapeutically relevant dose level (20 mg).~   "
71747|NCT02627820|"~     ATTRwt (also known as senile systemic, or senile cardiac amyloidosis) is a progressive heart~     disease, causing congestive heart failure. It is caused by amyloid protein deposits in the~     heart, that are derived from a normal protein, TTR, made in the liver. The aim of the study~     is to determine whether lowering the blood levels of TTR, by a weekly injection of a compound~     designed specifically to do this, will slow the progression of the disease when treated~     patients are compared to previously-followed patients who were not receiving this drug. The~     study also aims to determine how well this drug is tolerated and the existence and severity~     of any drug side-effects.~   "
71748|NCT02627807|"~     The purpose of this study is to compare individualized clinical target volume (CTV) based on~     disease extension risk atlas and computer-aided delineation with traditional CTV in intensity~     modulated radiotherapy (IMRT) for nasopharyngeal carcinoma (NPC), in order to confirm the~     efficacy and safety.~   "
71749|NCT02627794|"~     Endoscopic sinus surgery (ESS) is the gold standard surgical intervention for chronic~     rhinosinusitis that is not adequately controlled with maximal medical therapy.~      In some patients, underlying inflammation (discharge, edema and polyposis), compounded by~     inflammation caused by surgical trauma may lead to an uncontrolled healing response, which~     results in the synechiae formation in the middle meatus (MM).~      Incidence of synechiae formation varies in literature and ranges between 4-35%. Presence of~     middle meatal synechiae can impair sinus drainage, promote sinusitis, and limit endoscopic~     visualization of the sinus cavities postoperatively. This may result in difficulty in~     performing postoperative routine endoscopic debridement and examination, which is paramount~     to a successful outcome from ESS. Spacers are often inserted during surgery between nasal~     mucosal surfaces to prevent synechiae.~      The aim of this study is to see if a steroid-impregnated spacer is more effective at reducing~     inflammation after sinus surgery than a Silastic spacer.~   "
71750|NCT02627781|"~     The diagnosis of acute appendicitis remains a challenge in daily clinical practice. The high~     incidence of appendicitis drives the need to reduce morbidity and unnecessary costs due to~     negative appendectomies. The aim of the present observation study is to evaluate a diagnostic~     and therapeutic algorithm for suspected acute appendicitis.~      The investigators believe that this diagnostic algorithm helps to simultaneously avoid~     unnecessary operations, costs and radiation exposure.~   "
71751|NCT02627768|"~     The purpose of this study is to evaluate treatment retention in psoriatic arthritis~     participants with STELARA or tumor necrosis factor alpha inhibitor (TNFi) therapies in~     relation to effectiveness, safety, benefit/risk and to examine clinical response.~   "
71752|NCT02627755|"~     The use in a combined way of two systems of intubation (Glidescope + aScope) would condition~     an increase in the success rate of endotracheal intubation maneuver compared to conventional~     isolated Glidescope use in patients with clinical criteria of difficult airway.~   "
71753|NCT02627742|"~     To determine if a therapy regimen including treatment with The MetaNeb® System has a positive~     impact on the rate of pulmonary complications that occur in high risk post-operative~     patients. This is a non-randomized facility (or hospital) level pre-post intervention study.~   "
71754|NCT02627729|"~     Current study aims to analyze the outcomes of j-pouch and side-to-end anastomosis in rectal~     cancer patients treated with laparoscopic hand-assisted low anterior resection~   "
71755|NCT02627716|"~     The Joint Crisis Plan = SOS Plan is a reference to a particular form of psychiatric advance~     directive which involves the patient, the healthcare team, their relatives and a third party~     caregiver as intermediary for the project.~      The main objective is to evaluate the effectiveness of the SOS Plan (JCP) in terms of the~     reduction in hospitalisations within 18 months of its development by comparison to the~     standard psychiatric care.~      Thus, the investigators' proposal is that SOS Plan's are regularly reassessed every 6 months~     and again where there is an unplanned psychiatric readmission that lasts beyond two weeks.~      Single blind multicentre randomised trial with parallel control groups.~      Effectiveness study of a psychiatric care strategy.~   "
71756|NCT02627703|"~     This study is a multi-center BCCA study that evaluates the impact of the Oncotype DX® assay~     on the decision making of the treating physician and the patient. The Oncotype DX® assay is a~     commercially available diagnostic test that aids in a physician's treatment recommendation to~     a breast cancer patient. The study also has a pharmacoeconomic component.~   "
71757|NCT02627690|"~     Islet transplantation for type 1 diabetes results are still improving, and actually~     Insulin-independence with normal HbA1c is obtained in 50% of patients after 5 years, 80% of~     c-peptide positive patients. In addition to the need of 2 or 3 surgical or radiological~     interventions to inject islets, an immunosuppressive regimen is needed, which can be~     deleterious, particularly on kidneys. Moreover, long term beneficial effects of islet~     transplantation on stabilization or prevention of macro and micro vascular complications of~     diabetes has not been evaluated. In a preliminary work, it was observed a stabilisation or~     improvement of microvascular complications when compared to pre-transplant data.~      The aim of this study is to compare the evolution of diabetes complications, especially~     nephrologic, 10 years after islet transplantation and to compare it to patients with a~     brittle diabetes, 10 years after evaluation for islet transplantation, finally not performed.~      This case-control study will evaluate nephrologic parameters (creatinine, MDRD creatinine~     clearance, microalbuminuria, proteinuria) and other micro and macro-vascular complications of~     type 1 diabetes) before islet transplantation and 10 years after the transplantation or after~     the first evaluation in patients who finally did not underwent islet transplantation for~     various non nephrologic reasons~   "
71758|NCT02627677|"~     The purpose of this study is to compare the efficacy and safety of 2 starting doses of~     ponatinib compared to nilotinib in patients with imatinib-resistant chronic myeloid leukemia~     (CML) in chronic phase (CP).~   "
71759|NCT02627664|"~     The investigators prospectively enrolled 64 early PD patients (less than 3 years after the~     first symptom) in order to prospectively assess the natural history of non-dopaminergic~     symptoms.~   "
71795|NCT02627196|"~     The purpose of this trial is to develop valid scientific evidence for safety and~     effectiveness of Baroreflex Activation Therapy® with the BAROSTIM NEO® System in subjects~     with heart failure, defined as New York Heart Association (NYHA) functional class III and~     left ventricular ejection fraction (LVEF) ≤ 35% despite being treated with the appropriate~     heart failure guideline directed therapy, excluding subjects eligible for or actively~     receiving Cardiac Resynchronization Therapy (CRT).~   "
71760|NCT02627651|"~     18 children post acquired brain injury and 18 typically developed controls matched for age~     and gender.~      All children aged 10-18 yrs who understand simple commands.~      Tools:~        1. Heart rate monitor~        2. Six minute walk test~        3. The behavior rating inventory~      Method:~        1. At the introductory visit the child will be asked to walk for six minutes, to sit and~          perform a cognitive test and then to walk on a treadmill for 5 seconds.~        2. At the second visit the child will be asked to go on the treadmill for 5 minutes and at~          the same time to perform the cognitive assignment; After a rest the child will be asked~          to walk on the treadmill for 5 minutes and at the end to perform the cognitive~          assignment .~   "
71761|NCT02627638|"~     For more than seven years an osteopath has been working in the palliative care unit (PCU) and~     in both palliative care mobile team (PCMT) as a member of the multidisciplinary team. The~     patients referred to the osteopath by the palliative care physicians present pains related to~     cancer, but also to the treatment, in particular to surgery or radiotherapy. The osteopath~     can help with other symptoms such as constipation or dyspnoea. As this approach is provided~     in complement of the medicinal approach, it is not considered as an alternative medicine but~     as a complementary medicine associated to a conventional care. It seemed relevant to the~     investigators to ask the cancer patients undergoing osteopathic sessions for pain how they~     saw this complementary therapy.~   "
71762|NCT02627625|"~     The purpose of this study is to compare the absorption of three different inhalation products~     with the reference products in healthy volunteers.~   "
71763|NCT02627612|"~     Some Veterans who recently served in the military report significant psychological problems~     based on their experiences in the military. Stressors that these Veterans face when they~     transition out of the military can acerbate these problems and negatively impact their~     long-term physical and psychological well-being. The investigators are conducting a~     randomized controlled trial to evaluate the efficacy of providing Veterans who are~     transitioning back into their civilian communities trained, peer mentorship (Pro Vetus) and~     membership in a Veteran Support Organization (VSO) Team Red, White, and Blue (TM RWB) to~     reduce transition stressors, maintain psychological and physical health, reduce suicides and~     reduce criminal incidents.~   "
71764|NCT02627599|"~     -  Evaluate subjects in an prospective observational study~        -  Subjects will be administered scientifically validated questionnaires~        -  Evaluate Quality Improvement and Oxygen Utilization Improvements.~           1. Functional capability, dyspnea, oxygen saturation as primary endpoints~             1. Baseline Dyspnea Index (BDI)~             2. Transitional Dyspnea Index (TDI)~             3. Chronic Respiratory Disease Questionnaire (CRQ)~             4. Six minute walk distance (6MWD)~             5. Oxygen saturation using pulse oximeter~        -  The secondary endpoints:~             1. Portable oxygen source utilization~             2. Health care utilization (emergency room encounters, hospital admissions)~   "
71765|NCT02627586|"~     Several studies have shown that high-intensity interval training (HIIT) is more effective~     than moderate-intensity continuous exercise training (MICE) at improving functional capacity~     and quality of life in stable cardiac patients and can be performed safely.~      However, its effect on patients after recent myocardial infarction is currently unknown. In~     these patients avoidance of a negative remodeling after an acute myocardial infarction is of~     upmost importance. Therefore, assessment of the influence of HIIT on post-infarct left~     ventricular-remodeling is urgently needed.~      Therefore, the aim of this study is to determine the effect of HIIT on left ventricular (LV)~     remodeling (measured by LV end diastolic volume) compared to the effect of the more~     established MICE training modality.~      Further measurements include other parameters of LV remodeling (LV contractility, and brain~     natriuretic peptide), prognostic parameters (peak oxygen uptake, exercise capacity), cardiac~     output, endothelial function, leg muscle function and scores of quality of life. Further,~     certain blood parameters and heart rate variability measured by electro-cardiogram are~     measured to assess the safety of this type of training.~      Patients with first ST-segment elevation myocardial infarction (STEMI) or equivalent with~     onset of symptoms of ischemia and treated by primary percutaneous intervention within the~     preceding 4 weeks will be included.~      The HIIT and MICE is integrated in a 12-week exercise training program at the Inselspital~     Bern, consisting of 1) exercise training, 2) nutrition counselling and 3) psychotherapy. The~     exercise program will comprise 3 weekly exercise sessions lasting 90 minutes, supervised by~     experienced exercise therapists. The program focuses on endurance type exercises,~     strengthening and relaxation exercises as well as exercises to improve coordination skills.~     In the first 3 weeks (run-in-phase), all patients will complete three weekly MICE sessions.~     In the following 9 weeks, patients randomized to the intervention group will perform two~     weekly HIIT sessions and one MICE session per week. The control group will continue with~     three weekly MICE sessions for the 9 week intervention phase.~      A total of 144 patients will be recruited. Measurements will be performed at baseline, after~     a 3-week run-in-phase, and after the 9-week intervention phase. Safety measurements will be~     performed during the 4th and 12th week.~   "
71766|NCT02627573|"~     Purpose There is a growing evidence of high efficacy of post-transplantation cyclophocphomide~     (PTCy)-based GVHD prophylaxis in haploidentical and matched related and unrelated bone marrow~     transplantation. There is limitted, but growing data on safety and efficacy of this~     prophylaxis in unrelated and peripheral blood stem cell transplantations. Use of PTCy in~     chronic myeloproliferative neoplasms and myelodisplatic syndrome is of particular interest.~     On the one hand, PTCy could reduce the incidence of chronic GVHD and long-term bormidity. On~     the other hand, there is a concern, that PTCy can increase the incidence of graft failures in~     this group of patients. Currently published data indicate that low-dose Thymoglobulin-based~     prophylaxis is the most promissing compatitor in terms of acute and chronic GVHD control. So~     there is a rationale to randomize Thymoglobulin and PTCy as GVHD prophilaxis. Pre-transplant~     assesment of moratlity (PAM)-index will be used as the strata for randomization, as it is the~     paramter that takes into account the most important factors effecting survival. The~     conditioning regimen and the other two components of GVHD prophylaxis (mycophenolate mofetil~     and tacrolimus) will be identical in the two arms of the study.~   "
71767|NCT02627560|"~     After surgical procedures, interventions to reduce postoperative bleeding are of great~     importance. In this study, the effect will be investigated of smearing tranexamic acid, which~     is designed for injection, directly onto the raw wound surface (topical application) created~     during surgery. Topical application allows a small amount of drug to reach a large wound~     area, higher drug concentration in the exposed wound surface but very low concentration in~     the body, and no risk of injury from needles. The researchers have recently shown that~     topically applicated tranexamic acid reduces bleeding in women who had two-sided breast~     reduction surgery. Now it will be studied whether topically applicated tranexamic acid~     reduces bleeding after breast surgery for breast cancer.~      After surgery for breast cancer patients may also experience problems with long lasting~     seroma. Therefore it will at the same time be investigated whether topical tranexamic acid~     reduces the development of seroma in these patients.~   "
72763|NCT02614534|"~     The purpose of this study is to determine whether Hyperthermic Intra-peritoneal Chemotherapy~     (HIPEC) with Mitomycin C used during surgery for treatment of locally advanced colorectal~     carcinoma is effective in the treatment of locally advanced colorectal carcinoma.~   "
71768|NCT02627547|"~     Flavonoids are compounds that have been proven to have a beneficial effect on health, such as~     reducing the risk of developing cardiovascular disease and, in some cases, cancer. Citrus~     juices have a high flavonoid content. However, the absorption of flavonoids into the body is~     limited. This study will investigate whether being physically active improves the absorption~     of flavonoids.~      Endurance trained athletes will be invited to participate. Following screening procedures (a.~     Health Screening Questionnaire; b. height and weight measurement for calculation of Body Mass~     Index; c. maximal oxygen consumption (VO2max) uptake test, eligible participants will~     undertake two experimental tests; one during a period of normal training, the other~     immediately following 1 week of detraining.~      In the morning of the experimental trial participants will consume 500 mL of orange juice.~     Blood samples and urinary fractions will be collected prior (base line) to and for 24 hours~     after orange juice consumption. Participants will be asked to follow a special~     polyphenol-free diet and record weighed dietary intake for 2 days preceding each trial and~     during the day of the experimental trial.~      The study aims to:~        1. Determine the effects of training status of endurance athletes on bioavailability of~          flavanones in endurance trained individuals~        2. Determine whether changes in bioavailability of flavanones are related to changes in~          biomarkers of inflammation, oxidative stress, plasma lipids and insulin sensitivity.~   "
71769|NCT02627534|"~     Periodontal Diseases are considered the sixth complication of Diabetes Mellitus (DM). This~     close relationship between both diseases is characterized by mutual influence. The presence~     of DM might impair prognosis of diverse dental treatments due to its inflammatory nature,~     negative influence on wound healing, on bone biology, and the establishment of infections.~     Consequently, knowledge of new dental therapies and the biology of dental treatments for~     chronic periodontitis in diabetic patients can enhance quality of life and make these~     treatments more adequate for this common profile of patients.~   "
71770|NCT02627521|"~     The administration of Ticagrelor have demonstrated superiority to Clopidogrel in patients~     presenting with acute coronary syndrome (ACS) and remains a first line therapy as an adjunct~     to aspirin for patients admitted with ACS. The patient population treated with Ticagrelor at~     an early time point includes non ST elevation myocardial (NSTEMI) patients and those~     undergoing primary angioplasty for ST elevation myocardial infarction (STEMI). It is~     estimated that 10-15% of patients presenting with ACS have advanced coronary artery disease~     requiring Coronary Artery Bypass Surgery (CABG). The treatment guidelines recommend a delay~     of 5-7 days for CABG surgery in these patients for normalization of Ticagrelor induced~     platelet inhibition to reduce the risk of peri-operative bleeding. This delay may expose~     these high risk patients to adverse cardiac events while waiting for Ticagrelor effect to~     wean off. Furthermore, this empirical application of 5-7 day delay in all patients may be~     unnecessary due to the significant inter individual variability in response to Ticagrelor.~     There is limited data to determine the optimum timing of CABG surgery in ACS patients treated~     with Ticagrelor. The present study will determine the optimum timing of CABG in ACS patients~     treated with a loading and/or maintenance dose of Ticagrelor.~   "
71771|NCT02627508|"~     This is a research study to examine the tolerability and effectiveness of pregnenolone in~     individuals with autism. Pregnenolone is a naturally occurring steroid hormone in the brain~     that has been implicated in treating various psychiatric conditions. The investigators hope~     to learn the effects and safety of using pregnenolone in reducing irritability and~     sensitivity to sensory differences and improving social communication in individuals with~     autism. The investigators hope by studying the effects of pregnenolone in more detail, the~     investigators can design better ways to treat individuals with autism.~   "
71772|NCT02627495|"~     This study explores the effects transcranial Direct Current Stimulation (tDCS, Soterix ©) on~     Phantom Limb Pain for patients experiencing chronic phantom limb pain in open-label study~     design.~   "
71773|NCT02627482|"~     Most babies who measure small during pregnancy are born healthy. However, some are small~     because they are not growing as expected, usually because the placenta (the baby's 'life~     support' system) is not working properly. These babies are at greatly increased risk of dying~     before birth, and need to be delivered before they become poorly.~      Scans and electronic heartrate monitoring are currently used to monitor these babies. But~     they can only be used for short periods and don't always provide enough information to show~     when to deliver the baby.~      A small light monitor has been developed that safely records the baby's heart rate for up to~     16hrs by measuring electrical activity through sticky patches on the mum's skin (like a~     normal ECG). The woman carries on with her daily activities while wearing it. Monitoring the~     heart rate over a longer time may help with decisions about the timing of the delivery and~     could prevent stillbirth, the aim of our future study. This will include large numbers of~     women carrying small babies. Before the investigators can do this the investigators need to~     know whether:~        1. Wearing the monitor for 16hrs is practical and acceptable to pregnant women~        2. The monitor can provide useful information on the baby's heart rate at different stages~          of pregnancy.~      Thirty pregnant women whose babies are measuring small will be asked to wear the monitor on~     two occasions, for 16hrs each time. The women will describe what they think about wearing the~     monitor by completing questionnaires.~      The data from the monitor will be downloaded and compared with the woman's medical notes~     after the participant has delivered her baby. Results from this study will be publicised and~     will help with the design of the investigators future study into the usefulness of this~     monitor.~   "
71774|NCT02627469|"~     Objective: The effect of weekly professional oral care on the composition of the oral flora~     in dentate, dependent elderly residents was followed during a 12-month period.~      Background: Long-term, regular professional oral hygiene care reduces the total number of~     microorganisms and oral disease-related microorganisms. Less is known about the effect on the~     quality/composition of the remaining oral flora.~      Materials and methods: Thirty-three subjects were included in the study group and 35 in the~     control group. Dental status, presence of supragingival-plaque, labial minor gland secretion~     rate, and prescription medicines were recorded. Microbial samples, collected from~     supragingival plaque and the dorsum of the tongue, were analyzed using cultivation technique.~   "
72452|NCT02618616|"~     This was a randomized, double blind, placebo controlled, parallel group study in 129 subjects~     with moderate to severe psoriasis with a PASI score of at least 10. Following run-in,~     subjects were randomized and received either oral 30 mg ZPL-3893787 once daily or placebo~     once daily for 12 weeks.~   "
71775|NCT02627456|"~     Background:~      Malaria is still a health problem in Sub-Saharan Africa. Death rates are stable and have even~     increased in some areas. There are malaria vaccines. However, researchers think repeated~     immunizations with a vaccine called PfSPZ may work better.~      Objective:~      To see if PfSPZ is safe, tolerable, and effective against malaria.~      Eligibility:~      Healthy adults ages 18 to 50 years who live in the Doneguebougou area in Mali~      Design:~      Participants will be screened with medical history and physical exam.~      Participants will sign or fingerprint the consent form. They will take a survey to see how~     well they understand the study.~      Participants will give blood and urine samples.~      Participants will have at least one ECG: Soft electrodes will be stuck to the skin. A machine~     will record heart signals.~      Participants will have HIV counseling.~      Participants will be assigned to a group. Groups will get a different strength doses. Groups~     will get a different number of vaccines over different periods of time.~      If a participant develops a rash or injection site reaction, photographs may be taken.~      Participants will receive an oral anti-malaria drug during the study.~      Participants will be monitored for 3 to 6 months after the last vaccine.~   "
71776|NCT02627443|"~     This randomized phase I/II trial studies the side effects and how well carboplatin and~     gemcitabine hydrochloride with or without ATR kinase inhibitor VX-970 work in treating~     patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back~     (recurrent) and has spread to other places in the body (metastatic). Drugs used in~     chemotherapy, such as carboplatin and gemcitabine hydrochloride, work in different ways to~     stop the growth of tumor cells, either by killing the cells, by stopping them from dividing,~     or by stopping them from spreading. ATR kinase inhibitor VX-970 may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. Giving carboplatin and~     gemcitabine with or without ATR kinase inhibitor VX-970 may work better in treating ovarian,~     primary peritoneal, or fallopian tube cancer.~   "
71777|NCT02627430|"~     This phase I trial studies the side effects and best dose of talazoparib and heat shock~     protein (HSP)90 inhibitor AT13387 when given together in treating patients with solid tumors~     that have spread to other places in the body (metastatic) or ovarian, fallopian tube, primary~     peritoneal, or hormone negative breast cancer that have come back after a period of~     improvement (recurrent). Talazoparib and HSp90 inhibitor AT13387 may stop the growth of tumor~     cells by blocking some enzymes that are need for cell growth. HSp90 inhibitor AT1338 may also~     help talazoparib work better by making tumor cells more sensitive to the drug.~   "
71778|NCT02627417|"~     Due to its expected efficacy based on the retrospective data available in ITP, its relatively~     good safety profile and its very low cost , dapsone could be a good steroid-sparing~     second-line option for adults with ITP.~      This study is a phase III prospective multicenter randomized open trial comparing two~     treatment strategies:~        -  Arm A (experimental arm): prednisone at 1 mg/kg for 3 weeks + dapsone at 100 mg per day~          up to week 52 if an initial response is achieved.~        -  Arm B (control arm): prednisone alone at 1 mg/kg for 3 weeks followed by monitoring and~          standard of care The aim of the study is to demonstrate the efficacy of dapsone based~          on the overall response rate (including response and complete response) as a second-line~          treatment for adults with newly-diagnosed persistent or chronic (modified by amendment~          08/11/2016) ITP not achieving a durable response with corticosteroids. The primary~          endpoint will be the overall response-rate (response or complete response according to~          standard definitions) in both arms at week 52 (1 year).~      The secondary endpoints are the following :~        -  To assess the safety of dapsone over the study period and especially the incidence of~          cutaneous reactions.~        -  To analyze the overall response rate (platelet count > 30 x 109/L with at least a~          doubling of the pre-treatment count in the absence of any other ITP treatment) in both~          treatment arms at week 24.~        -  To compare the rate of complete response and failure in both arms at 24 and 52 weeks.~        -  To compare time to treatment failure (TTF) in both arms~        -  To investigate the mechanisms of action of dapsone in ITP in a subgroup of patients~          (ancillary study)~   "
71779|NCT02627404|"~     Bipolar disorder is a complex, multifactorial disorder with the intervention of genetic~     vulnerability factors. To help the identification of these genetic factors and to improve~     genotype-phenotype correlation, the identification of endophenotype through the exploration~     of vulnerability characteristics in unaffected first degree relatives have been recommended.~     For this purpose, the investigator include bipolar patients, unaffected first degree~     relatives and control subjects to perform genetic association studies and subphenotype~     analyses. In this study the investigator will focus on subgroups defined according to the~     existence of abnormal circadian rhythm (a major indicator of bipolar vulnerability).~      Lithium is the leading treatment of bipolar disorders but prophylactic lithium response is~     highly variable and difficult to predict due to lack of biomarkers of response. To explore~     lithium response variability and to identify biomarkers of response, the investigator~     characterise lithium response using ALDA scale to conduct pharmacogenetic studies and~     pharmacokinetic studies of lithium extended release, in the subpopulation of patients treated~     with lithium. As lithium is a circadian agent, the investigator will also explore the links~     between lithium response and circadian phenotypes. Finally, using Li7 magnetic spectroscopy,~     the investigator will compare lithium brain distribution in a small sample of good and~     partial responders to lithium.~   "
71780|NCT02627391|"~     Many cardiologists are convinced that early surgery in asymptomatic aortic stenosis (AS)~     saves lives. However there is currently no direct evidence for this and most recommendations~     from the ESC/ EACTS or ACC/ AHA in this field are supported by Level-B or C evidence.~     Therefore, the investigators designed a randomized controlled trial to demonstrate whether~     early surgery improves mortality and morbidity of patients with asymptomatic severe AS and~     low operative risk.~   "
71796|NCT02627183|"~     The main purpose of this project is to determine the impact of atrial fibrillation~     interventions (catheter ablation and exercise training) on circulating BDNF concentrations in~     patients with atrial fibrillation. It also seeks to determine if there is a relation between~     circulating BDNF concentrations and mental health (depression severity, quality of life and~     symptoms) among those undergoing interventions for atrial fibrillation catheter ablation or~     exercise training.~   "
72498|NCT02618018|"~     The purpose of this study is to evaluate the efficacy and stability of AT TORBI 709M 4-haptic~     toric IOL in cataract surgery.~   "
71781|NCT02627378|"~     A highly pathogenic human coronavirus causing respiratory disease emerged in Saudi Arabia in~     2012. This viral infection termed Middle East respiratory syndrome coronavirus (MERS-CoV) is~     associated with high mortality rate in approximately 36% of reported patients.~      The World Health Organization (WHO) reported 1,374 laboratory-confirmed worldwide infections,~     including at least 490 related deaths, from September, 2012, to July 24, 2015.2 The higher~     incidence of MERS-CoV infections in Saudi Arabia may be related to multiple factors,~     including seasonality, increased proactive screening, poor infection control measures, low~     relative humidity, and high temperature.~      Infected patients with MERS-CoV usually have abnormal findings on chest radiography, ranging~     from subtle to extensive unilateral and bilateral abnormalities. MERS progresses rapidly to~     respiratory failure, in approximately 2/3 of infected patients, which has a high mortality~     rate, particularly in immunocompromised patients.~      Extracorporeal membrane oxygenation (ECMO) has emerged as a rescue therapy in patients with~     refractory hypoxemia during the H1N1 epidemic.The use of veno-venous (VV)-ECMO provides~     respiratory support for patients with respiratory failure, whereas the use of veno-arterial~     (VA)-ECMO could be helpful in those with cardiorespiratory failure.10 However, the survival~     rate of the infected patients with H1N1 who required the use of ECMO varies considerably~     among the Caucasian and Asian countries (90% survival in Sweden and 83% in the UK13 vs. 35%~     in Japan). This large discrepancy could be explained with lack of satisfactory equipment,~     therapeutic guidelines, training of staff, and effective systems allowing patient transfer to~     the dedicated ECMO centres.~      Guery and co-investigators described the use of ECMO in two French patients with~     cardiorespiratory failure secondary to MERS-CoV infection.This has been extended for~     treatment of refractory hypoxemic respiratory failure during the Saudi MERS-CoV outbreak.~   "
71782|NCT02627365|"~     The study aims to develop and evaluate the efficacy and causal mechanisms of an interactive~     SMS intervention to optimize individual health and secondary HIV prevention benefits of ART~     in HIV-positive FSWs.~   "
71783|NCT02627352|"~     The purpose of this study is to investigate the surgical outcomes of the micropulse~     transscleral cyclophotocoagulation (mTSCPC) in patients with uncontrolled glaucoma; analyze~     intraocular pressure lowering effect; and correlate related treatment parameters pending~     enrollment of sufficient numbers of dark pigmented versus light pigmented eyes.~   "
71784|NCT02627339|"~     The purpose of this study is to build a database of results from a new test that measures~     contrast sensitivity (the Spaeth-Richman Contrast Sensitivity Test (SPARCS)). Contrast~     sensitivity is an important part of your ability to see. When contrast sensitivity decreases,~     you are less able to see objects and detect motion. For instance, if you have decreased~     contrast sensitivity, you might be less able to read, see in the dark, drive, hit a ball, or~     walk safely. Decrease in contrast sensitivity leads to a decrease in quality of life.~   "
71785|NCT02627326|"~     The aim of this prospective randomized controlled clinical trial is to evaluate the~     effectiveness of chlorhexidine intracanal medicament along with periodontal treatment in~     concomitant endodontic periodontal lesions with communication in terms of periodontal~     healing. Forty-seven patients were randomly divided into: group 1: conventional endodontic~     treatment with open flap debridement (OFD after 3 month of endodontic treatment) were~     performed, in group 2: endodontic treatment with 2% chlorhexidine gel (CHX) as an intracanal~     medicament placed in root canals and after 3 month OFD were performed. Primary outcome~     variables included probing pocket depth, clinical attachment level and bleeding on probing.~   "
71786|NCT02627313|"~     Conventional breast radiotherapy is delivered to the entirety of the breast in fractionated~     treatments given over several weeks. While these techniques are effective, there is a risk of~     late adverse events from irradiation of surrounding normal tissues and the protracted nature~     of the treatments is inconvenient to patients and resource-intensive for health care systems.~     There is an unmet need for novel treatments that can be delivered more quickly, with reduced~     normal tissue exposure, and without compromising efficacy. The GammaPod is a breast-specific~     radiotherapy delivery device that holds the promise in addressing these needs. Employing the~     engineering and physics principles from stereotactic radiotherapy, it allows delivery of a~     highly-localized radiation dose to a very limited volume of breast. The Ottawa Hospital is~     the only Canadian member of a consortium of five academic institutions that have acquired the~     GammaPod in order to rigorously evaluate its use in clinical trials. The aim of the current~     project is to complete a mandatory clinical feasibility study of the GammaPod as part of the~     application for Investigational Testing of Medical Devices from Health Canada. The study will~     focus on the use of the GammaPod to deliver a radiotherapy boost, that is, a localized dose~     of radiation just around the surgical bed, in a single treatment.~   "
71787|NCT02627300|"~     Patients will be followed from the time of completion of the SCGAM 01 trial until octanorm~     becomes commercially available in the USA, until the sponsor decides to terminate the trial,~     or until a patient's treatment duration of 2 years is reached (whichever occurs first).~   "
71788|NCT02627287|"~     This trial is conducted in Europe. The aim of this trial is to compare Injections with the~     Medical Device DV3316 Pen-injector versus FlexPen®.~   "
71789|NCT02627274|"~     This first-in-human, open-label, multicenter, Phase Ia/Ib, adaptive, multiple ascending-dose~     study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD),~     and preliminary anti-tumor activity of RO6874281 as a single agent (Part A) or in combination~     with trastuzumab or cetuximab (Part B or C).~   "
71790|NCT02627261|"~     Three methods including flow cytometry, next generation sequencing and determination of~     circulating tumor cells will be performed at different time points in patients with~     previously undiagnosed multiple myeloma in order to determine the most sensitive method to~     detect residual disease~   "
71791|NCT02627248|"~     RATIONALE:~      Huaier (Trametes robiniophila Murr) is a traditional Chinese medicine, which has been widely~     used in China for many years. The investigators have found that Huaier could exert~     synergistic effects with Epirubicin, Cyclophosphamide, and Paclitaxel on breast cancer cells.~     It is not yet known whether combination chemotherapy is more effective when given together~     with Huaier in the neoadjuvant setting .~      PURPOSE:~      To evaluate the effects of treatment with Huaier Granule in managing locally advanced breast~     cancers with synergistic action of the neoadjuvant chemotherapy.~   "
71792|NCT02627235|"~     This pilot study represents an initial foray into delivering an Individual Voice~     Response-based (IVR) physical activity intervention for cancer risk among sedentary adults in~     the Deep South.~   "
71793|NCT02627222|"~     The study comprises an open-label randomized controlled trial investigating the efficacy of~     consuming a daily ration of pro-vitamin A biofortified cassava on vitamin A status of~     Nigerian children, aged 3-4 years old (n=200).~   "
71794|NCT02627209|"~     This study evaluates the significance of differences in serum angiotensin converting enzyme~     and lysozyme levels of patients with ocular involvement of other autoimmune inflammatory and~     infectious diseases.~   "
71797|NCT02627170|"~     The human cornea is affected by the magnitude and velocity of both internal and external~     forces because the cornea has both static and dynamic resistance components. Considering~     these natures of the human cornea, many investigators have tried to demonstrate corneal~     biomechanical properties to understand these characteristics of the cornea. Corneal~     biomechanical properties are known to influence the accuracy of measurements in intraocular~     pressure (IOP) and are recognized as important factor to explain the susceptibility of~     development of glaucomatous damage. Until recently, the only instrument which enabled the in~     vivo measurements of the ocular biomechanical properties was ocular response analyzer (ORA,~     Reichert Ophthalmic Instruments, Depew, NY, USA).8 The ORA has been used to assess the~     biomechanical properties of the cornea according to the dynamic bidirectional applanation~     process. A dynamic Scheimpflug analyzer (corneal visualization Scheimpflug technology [Corvis~     ST], OCULUS, Wetzlar, Germany) has been introduced recently and has become a useful~     instrument for evaluating corneal biomechanical properties. The dynamic Scheimpflug analyzer~     captures the dynamic process of corneal deformation caused by an air puff using an~     ultra-high-speed Scheimpflug camera at a rate of up to 4,330 images per second. Until now,~     well-organized analysis on the normative data of the corneal biomechanical profiles measured~     with the dynamic Scheimpflug analyzer has not been reported yet. Hence, in the present study,~     we aim to conduct normative data analysis for the corneal biomechanical properties with the~     dynamic Scheimpflug analyzer in South Korea.~   "
71798|NCT02627157|"~     The human cornea is affected by the magnitude and velocity of both internal and external~     forces because the cornea has both static and dynamic resistance components. Considering~     these natures of the human cornea, many investigators have tried to demonstrate corneal~     biomechanical properties to understand these characteristics of the cornea. Corneal~     biomechanical properties are known to influence the accuracy of measurements in intraocular~     pressure (IOP) and are recognized as important factor to explain the susceptibility of~     development of glaucomatous damage. Until recently, the only instrument which enabled the in~     vivo measurements of the ocular biomechanical properties was ocular response analyzer (ORA,~     Reichert Ophthalmic Instruments, Depew, NY, USA).8 The ORA has been used to assess the~     biomechanical properties of the cornea according to the dynamic bidirectional applanation~     process. A dynamic Scheimpflug analyzer (corneal visualization Scheimpflug technology [Corvis~     ST], OCULUS, Wetzlar, Germany) has been introduced recently and has become a useful~     instrument for evaluating corneal biomechanical properties. The dynamic Scheimpflug analyzer~     captures the dynamic process of corneal deformation caused by an air puff using an~     ultra-high-speed Scheimpflug camera at a rate of up to 4,330 images per second. Until now,~     well-organized analysis on the normative data of the corneal biomechanical profiles measured~     with the dynamic Scheimpflug analyzer for young healthy adults has not been reported yet.~     Hence, in the present study, we aim to conduct normative data analysis for the corneal~     biomechanical properties with the dynamic Scheimpflug analyzer in a cohort of young healthy~     adults in South Korea.~   "
71799|NCT02627144|"~     This is a non-interventional, multicenter study to evaluate efficacy and safety of~     intravenous bevacizumab (Avastin) in combination with interferon alpha-2a immunotherapy for~     first-line treatment in participants with advanced and/or metastatic renal cell cancer (mRCC)~     in daily routine.~   "
71800|NCT02627131|"~     The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow~     mononuclear stem cells in the management of autism.~   "
71801|NCT02627118|"~     The aim of the study is to identify hepatic enzyme and estrogen-dependent biochemical changes~     that occur when dialysis patients are treated with dialyzers known to leach BPA (Bisphenol-A)~     into the blood, such as the commercially available Fresenius F160NR, as compared with the~     same chemical evaluations in patients being treated with the non BPA containing ELISIO-15H~     dialyzer. Evaluations of patient's chemistries will be obtained prior to and after 2 months~     of standard dialysis treatments with each dialyzer.~   "
71802|NCT02627105|"~     This is a 6 month long study to evaluate the inclusion or exclusion of beef within a weight~     loss program.~   "
71803|NCT02627092|"~     The purpose of this study is to assess the impact of copper linens on hospital acquired~     infections and drug resistant bacteria.~   "
71804|NCT02627079|"~     The proposed pilot study will develop and test feasibility and preliminary efficacy of an~     exercise motivation intervention using a 12-week smartphone-text messaging program tailored~     to physical activity data retrieved from a Fitbit. Target population is 15 cancer survivors~     and 15 patients actively undergoing cancer treatment.~   "
71805|NCT02627066|"~     This is a 12 month randomized clinical trial in which patients with renal failure undergoing~     maintenance hemodialysis (MHD) therapy will be placed on a volume reduction protocol that~     includes a novel low sodium dietary education program mediated by a lifestyle interventionist~     with significant collaboration from the existing clinic staff. Participating patients will be~     randomized to receive: 1) the volume control protocol alone (VC), or 2) the volume control~     protocol + physical activity and exercise counseling (VCE) from the lifestyle interventionist~     (LI). A research dietitian (RD), working in collaboration with the existing clinic RD, will~     develop a program to immerse clinics in a culture of sodium restriction. The research RD will~     train the LI and other clinic staff (nurses, technicians, etc) to help disseminate this~     program, modeled after the clinic-wide dissemination approach used in Izmir, Turkey (Dr.~     Ercan Ok). In addition, the LI will provide exercise and physical activity counseling to the~     participants randomized to the exercise group, utilizing a SCT-based approach. The~     Investigators hypothesize that mean arterial pressure will be reduced, and physical function~     increased, in all patients at 12 months, but the magnitude of these improvements will be~     greater in the VCE group.~   "
71806|NCT02627053|"~     Anticoagulant therapy is generally recommended for all patients presenting with acute~     symptomatic splanchnic vein thrombosis, starting with either low-molecular weight heparin~     (LMWH) or unfractionated heparin and continuing with the vitamin K antagonists in most~     patients. Rivaroxaban is approved for the treatment of deep vein thrombosis and pulmonary~     embolism, but no studies have assessed the safety of rivaroxaban in the setting of splanchnic~     vein thrombosis. The investigators aim to collect prospective information on the safety of~     rivaroxaban in a pilot cohort of 100 patients with acute splanchnic vein thrombosis without~     liver cirrhosis.~   "
72784|NCT02614261|"~     The main purpose of this study is to evaluate the efficacy of the study drug known as~     galcanezumab in participants with chronic migraine.~   "
71813|NCT02626962|"~     This is a Phase 2, single-arm study of nivolumab combined with ipilimumab in subjects with~     previously untreated, unresectable or metastatic uveal melanoma. Previous studies with~     immunotherapy have shown promising results and this synergistic combination was very~     effective in other tumors. This study will allow for further characterization of the safety~     and clinical activity of nivolumab combined with ipilimumab in subjects with uveal melanoma.~   "
71814|NCT02626949|"~     By 2015 half of the people living with HIV infection in the U.S. are estimated be over the~     age of 50, and this cohort of patients with well-controlled plasma viremia is aging at a more~     rapid pace than their non-HIV peers. Long-term chronic inflammation plays a critical role in~     premature aging in HIV-infected adults. Markers associated with chronic inflammation,~     including IL-6, CRP, sCD14 and d-dimer, have not only been shown to be present at higher~     levels in HIV-infected adults, but are also correlated to a wide variety of morbidities and~     mortality. The goal of this project is to determine the impact of two different interventions~     -- Mindfulness-Based Stress Reduction (MBSR) and Health Enhancement Program (HEP) -- on~     reducing biological markers associated with chronic inflammation in HIV-infected adults with~     an undetectable HIV viral load. In order to achieve this goal, a pilot RCT with 120 subjects~     over 50 years old who are on anti-retroviral therapy (ART) will be conducted with the~     following specific aims: 1) to assess the effect of MBSR and/or HEP on biomarkers of chronic~     inflammation (IL-6, CRP, sCD14, d-dimer), and, 2) to explore whether changes in psychological~     well-being (anxiety, depression, fatigue, cognitive functioning) mediate the impact on~     chronic inflammation. Subjects will be randomized to participation in a group MBSR course or~     to the HEP group both of which consist of 8 weekly sessions followed by 6 monthly booster~     sessions. Three time points will be measured: baseline, 8 weeks (immediately after completion~     of weekly intervention), and 6-months post-completion of weekly intervention. Mixed linear~     and structural equation model will be used to test the study hypotheses. The proposed study~     is innovative in that it is the first to explore the impact of a complementary mind-body~     intervention on chronic inflammation in HIV-infected adults. Given that the consequences of~     early aging in this cohort will be a burden on the health care system as well as a medical,~     social and psychological burden on those living with HIV, the study has the potential to have~     a major public health impact.~   "
71815|NCT02626936|"~     In previous studies, investigators have studied if a pre-meal insulin bolus based on~     estimated carbohydrate meal size would alleviate the burden of carbohydrate counting without~     a significant degradation in postprandial glucose control. With this strategy, the patient~     would only have to evaluate the size of the meal in terms of carbohydrate (snack, regular,~     large or very large) It is however important to establish safety of this simplified meal~     bolus approach. The safety of overestimating a meal insulin bolus in the context of single~     and dual-hormone CLS with the simplified meal strategy needs to be determined. Computer~     simulation will be used to get a reasonable estimate of risks related to over-estimation with~     single-hormone closed-loop while over-estimation with dual-hormone closed-loop will be tested~     in adults with type 1 diabètes~      Investigators hypothesize that dual-hormone closed-loop with overestimated meal size bolus~     will not increase time below 4.0 mmol/L compared to dual-hormone closed-loop with an~     adequately estimated meal size bolus~   "
71816|NCT02626923|"~     Hypotension does not occur with Maraviroc at a dose of 600 mg/day~   "
71817|NCT02626910|"~     The project proposes to fill gaps in the understanding of disparities in healthcare and~     primary care provider (PCP) quality from the perspectives of adult Medicare beneficiaries~     with disabilities compared to those without disabilities. Studies document racial/ethnic,~     economic, and education-related disparities, but little is known about healthcare disparities~     related to disability.~   "
71818|NCT02626897|"~     This cross-over study of 12 patients with sarcoidosis will look at two different widely-used~     accelerometer devices. These devices are wrist worn and similar in size to a wrist-watch.~     They measure daily activity levels. The investigators hope to use one of these devices in the~     future within a randomised-controlled trial looking at using methylphenidate for the~     treatment of sarcoidosis-associated fatigue. In order to ensure that the investigators choose~     the ideal device the investigators wish to compare the GENEActiv and ActiGraph GT3X devices.~     Participants will be required to wear the devices for 7 days each, with 6 patients beginning~     with the GENEActiv device and changing to the ActiGraph device after 7 days, the remaining 6~     participants starting with the Actigraph before changing to the GENEActiv. Patients will~     complete a short exit questionnaire about their experience with the devices and their~     preference. The best device will be determined by both patient preference and reliability of~     collecting data.~   "
71819|NCT02626884|"~     The purpose of this trial is to determine~        1. Disease stabilization/response rate after six 21-day cycles of ibrutinib~        2. Remission status after six, twelve and 20 21-day cycles of ibrutinib~   "
71820|NCT02626871|"~     The primary purpose of the FIN-bioAVR registry is to assess the incidence of AF, strokes and~     major bleeding events in patients undergoing aortic valve replacement. This retrospective~     multicenter registry will include 850 patients with aortic valve replacement using~     bioprosthesis.~   "
71821|NCT02626858|"~     The aim of the present study is:~        1. to verify whether the delineation of the tumour bed, based on the combination of the~          visible postoperative changes and the position of the surgical clips on a CT scan in~          treatment position acquired 1 week before the start of the radiotherapy (RT), provides~          an accurate localisation of the boost volume compared to the localisation of the tumour~          on a pre-operative CT-scan.~        2. to document the changes that occur in the tumour bed as seen on a CT scan as a function~          of the delay between surgery and radiotherapy.~        3. to determine the ideal number and the positioning of the clips needed to reproduce the~          best treatment volume for the boost.~        4. to propose new guidelines for tumour bed definition and delineation based on the study~          findings.~   "
71822|NCT02626845|"~     This is a phase IV, single-center, randomized, placebo-controlled pilot study that will~     evaluate the efficacy of rituximab at inducing otolaryngologic remission in GPA patients with~     active otolaryngologic disease.~   "
71823|NCT02626832|"~     This study aims to develop a method for the assessment of central NMDA receptor functioning~     in patients with depression and schizophrenia. For this purpose a transitional approach is~     used based on preclinical studies that show a dose-dependent relationship between the~     activity of hypothalamic NMDA receptor and plasma AVP response to increasing plasma~     osmolality. Patients with schizophrenia, depression and healthy controls participated in this~     study. The Investigators found that in a subgroup of patients with schizophrenia the AVP~     response was low and that in a subgroup of subjects with depression the AVP response was high~     compared to healthy controls.~   "
72384|NCT02619500|"~     The purpose of this clinical trial is to compare the use of thrust manipulation to non-thrust~     mobilizations for mechanical neck pain when they are applied to both the cervical and~     thoracic spine. Both of these techniques have been compared in previous trials but a~     pragmatic approach will be employed as well as controlling for clinical equipoise.~   "
71824|NCT02626819|"~     Compared to the general public, a higher percentage of Veterans are obese or overweight with~     a weight-related medical condition. The VA currently offers an effective weight management~     program called MOVE!, but the majority of eligible patients do not attend. Veterans see their~     primary care providers (PCPs) very frequently, making it an important place to receive~     information on weight management. However, PCPs often fail to discuss weight management with~     patients, so interventions are needed to encourage weight management counseling within the~     team-based care model used in primary care at the VA. Investigators used focus groups,~     interviews, and other research methods to develop the MOVE! Toward Your Goals (MTG)~     intervention. This intervention combines online tools, counseling by a health coach, and the~     team-based care model to deliver weight management information to patients.~      Investigators will conduct a randomized controlled trial of 320 Veteran patients and their~     providers at two VA sites (Manhattan and Brooklyn campuses, New York Harbor Healthcare~     System) to study the impact of the 12-month MTG intervention when compared to Enhanced Usual~     Care. Veterans in the MTG intervention arm will take the MTG tool, receive personalized~     weight management materials, health coach counseling, and go to their scheduled primary care~     (PC) visit. After the initial visit, MTG-arm Veterans will receive follow up telephone~     coaching over 12 months. All Veterans will attend follow-up visits at 3, 6 and 12 months to~     assess body mass index, diet and physical activity, and goal attainment.~      The objectives of this study are to: (a) test the impact of the MTG intervention on weight~     and behavior changes; (b) identify predictors of weight loss in Veterans who use goal setting~     techniques; and (c) determine the impact of the MTG intervention on primary care team~     obesity-related counseling practices and attitudes.~   "
71825|NCT02626806|"~     1. To compare hs-TnT levels after a cardiac stress test in patients with vs. patients~          without CAD~        2. To assess the level of post-exercise hs-TnT predicting CAD (using ROC-analysis)~        3. To determine the sensitivity, specificity and accuracy of this exercise-induced hsTopT~          level in predicting CAD, either alone or in relation to traditional patient-related and~          exercise test-related metrics~   "
71826|NCT02626793|"~     The objective of this Non-interventional study (NIS) is the collection of data on the~     utilization of Apremilast under routine conditions in Germany. Patients' quality-of-life and~     treatment satisfaction on treatment with Apremilast in daily practice will be documented.~     Moreover, physician's and patient's assessments of the effectiveness and safety of Apremilast~     will be recorded.~   "
71827|NCT02626780|"~     The general objective of this study is to conduct a safety and feasibility study of a single~     injection of autologous adipose-derived SVF for the treatment of alopecia.~   "
71828|NCT02626767|"~     Low-volume high-intensity interval exercise training may improve aspects of health and~     fitness in young people, but interventions must be practical and engaging. The investigators~     examined the effect of a novel school-based low-volume high-intensity interval training~     programme on health, fitness and physical activity outcomes in adolescent school pupils. 101~     English adolescents aged 13-14 years took part in the study. Participants were healthy male~     and female volunteers, recruited from four schools in Northeast England. Using a~     non-randomised design, two schools took part in the intervention, and two were assigned to~     the control. Those in the intervention group completed a 10-week school-based high-intensity~     interval exercise training programme. The intervention took place three times per week, and~     comprised of 4-7 repetitions of 45 s maximal effort exercise (boxing, dance, soccer and~     basketball drills), each interspersed with 90-s rest. Participants were encouraged to work~     maximally during the 45-s repetitions. Control participants were instructed not to change~     their lifestyle, dietary or physical activity habits during the intervention period, and~     maintain their normal school physical education routine. Study outcomes were blood lipid and~     glucose levels, body composition, cardiorespiratory fitness, carotid intima-media thickness,~     physical activity levels, serum C-reactive protein levels and blood pressure.~   "
71829|NCT02626754|"~     This is a multi-national, phase II, single arm study to explore the safety/efficacy and~     potential biomarkers on sunitinib 2/1 schedule for Asian patients with advanced renal cell~     carcinoma.~   "
71830|NCT02626741|"~     The purpose of this study is to determine whether meal replacement, SlimWell ®, is effective~     in the treatment of obesity patients with metabolic syndrome.~   "
71831|NCT02626728|"~     Most recently, the Transanal Minimally Invasive Surgery (TAMIS) approach combined with~     single-port technology has allowed that pelvic surgery can be laparoendocopically performed~     from both its abdominal and perineal aspects.Previously, a strong negative association~     between medium- and long-term survival and male gender with narrow pelvis have been reported.~     TAMIS has a significant potantial for improving the quality of the surgical resection of~     rectal tumors in men with visceral obesity and narrow pelvis. This group of patients have~     also a high rate of conversion to open surgery. Focusing on improvement in intraoperative~     conditions and surgical techniques rather than routine conventional procedures may be the way~     to go concerning favorable short- and long-term outcomes. The selection of adequate surgical~     approach to the high-risk patients with visceral obesity and a bulky mesentery may prevent or~     limit the risk for anastomotic leakage and improve oncologic margin clearence. This is a~     prospective observational feasability study of the TAMIS-procedure.~   "
71832|NCT02626715|"~     The purpose of this study is to compare safety and efficacy of reduced-intensity conditioning~     and myeloablative conditioning regimens prior to HSCT in high-risk AML/MDS pediatric and~     young adult patients. This study investigates the use of two novel conditioning therapies for~     hematopoietic stem cell transplant (HSCT). The primary focus of both the investigators'~     myeloablative and reduced-intensity conditioning regimens is to reduce overall toxicity so~     that pediatric and young adult patients with high-risk AML/MDS with significant pretransplant~     comorbidities who would have been ineligible to proceed to HSCT previously can now receive~     potentially life-saving treatment.~   "
71833|NCT02626702|"~     Exploring the immune mediators of early pregnancy prospectively may help to identify new~     early interventions that will increase the likelihood of success and help women make informed~     decisions regarding their pregnancies.~   "
71834|NCT02626689|"~     This is a multi-site, prospective, observational study implemented in β-thalassemia treatment~     centers from 5 countries (Italy, Turkey, Greece, Lebanon, and Thailand). Approximately one to~     two study sites will be identified per country and approximately 20 β-thalassemia subjects~     will be enrolled per country (10 transfusion dependent (TD) and 10 Non-transfusion dependent~     (NTD) with a total of approximately 100 subjects. This study will not interfere with or~     influence the routine clinical management of β-thalassemia patients. Outcomes of interest~     will be collected prospectively for up to 6 months.~   "
71890|NCT02625948|"~     The purpose of this study is to determine if computed tomography angiography can predict~     which individuals with intracerebral hemorrhage will experience significant growth in the~     size of the hemorrhage. For individuals who are at high risk for hemorrhage growth, the study~     will compare the drug Tranexamic acid to placebo to determine the effect and safety of on~     intracerebral hemorrhage growth~   "
71835|NCT02626676|"~     Background: In Chronic Kidney Disease patients, it is crucial to begin treatment as soon as~     possible in order to minimize the complication-related risks. Encouraging patients to adhere~     to their treatment plans is a great challenge for health care professionals. Objectives: The~     aim of this study is to evaluate the impact of a nutrition educational programme on the~     hyperphosphatemia using the transtheoretical model of eating behavior. Subjects and Methods:~     A prospective Interventional study is being conducted in a dialysis centre with 180 stage 5D~     Chronic Kidney Disease patients who exhibit phosphate serum levels > 5.5 mg/dL. The~     educational intervention consists of lectures and group dynamics sessions performed during~     dialysis sessions. Anthropometric, clinical, demographic and laboratory parameters (serum~     phosphorus concentration will be evaluated and the transtheoretical model of eating behavior~     (TMFB) will be applied pre- and post-intervention.~   "
71836|NCT02626663|"~     The investigators propose to characterize MPs in aHUS and TTP both at the onset and~     throughout treatment. The investigators believe that the number, size, and cell origin of MPs~     will differ between these two diseases. The hypothesis is that endothelial derived MPs will~     be higher in number and comprise a larger portion of the MP population in aHUS and that~     platelet MPs will comprise a larger number and greater proportion of MPs in TTP. The~     investigators believe that MP identity and number can be used to reliably differentiate~     between aHUS and TTP at disease onset.~   "
71837|NCT02626650|"~     College athletes will be recruited to complete a voluntary online survey that will take~     approximately 10 minutes. In this survey, they will answer a series of questions related to~     the concussion symptoms they have experienced in their recent sports season, their opinions~     related to concussions and concussion treatment, and demographics.~   "
71838|NCT02626637|"~     During cancer treatment children are less active than their health peers. This inactivity~     persists into survivorship and can negatively affect health and quality of life. Physical~     activity may also improve fatigue, a prevalent and distressing symptom during treatment.~     Improving health behaviors during treatment can have lifelong benefits for cancer survivors.~     In this study, the effectiveness of the Kids are Moving exercise program will be evaluated.~     The exercise program will follow program guidelines set up by the American College of Sports~     Medicine and will be adapted for children with cancer. Children ages 6 to 18 years, who are~     receiving chemotherapy, and their parents, will be coached on how to increase their physical~     activity and will receive an exercise prescription. This will occur as part of the standard~     care they receive from the nurse practitioners during the first six months of their~     outpatient visits. Investigators want to find out if children in the Kids are Moving program~     are more active and have less fatigue. Activity will be measured through patient~     questionnaires about activity and fatigue, and by wearing the FitBit activity tracker and an~     actigraph. Outcomes will be compared to measurements collected from children who received~     usual care before the exercise program started.~      Physical activity is a vital for improving health and quality of life and for providing~     energy for engaging in positive life experiences as children move along the developmental~     continuum to a long and healthy future. Outcomes of the study will provide a foundation for~     larger multi-site clinical trials.~   "
71839|NCT02626611|"~     This is a phase 2 randomized, double-blind, placebo controlled study which will be conducted~     at multiple centers in the U.S. All subjects will receive oral immunotherapy for their~     specific food allergies (limited to 5 of those food allergens in Investigational New Drug~     (IND) 14831). All subjects will receive Omalizumab for 16 weeks. The subject's allergens will~     be introduced in a rush desensitization day at week 8. Subjects will return to clinic to~     escalate the dose of their allergens until 2,000mg protein of each allergen is reached~     Subjects will return to clinic for a DBPCFC to each allergen at week 30. If subjects are~     nonreactive to 2 or more allergens during their DBPCFC at week 30 they will be randomized to~     one of three double blinded arms: Arm A- continue with current dose (2000 mg each food~     allergen protein), Arm B-300 mg of each food allergen protein, Arm C-placebo (avoiding food~     allergen protein), their current dose. All subjects will return to clinic for a DBPCFC to~     each allergen at week 36. The final challenge of week 36 will be the final end of study~     visit.~      Safety is a paramount concern in the study design and will be monitored carefully throughout~     the study. Study subjects and their parents/guardians will receive extensive education on~     food allergy reactions and medication use.~   "
71840|NCT02626598|"~     This is a single center study for adult females or males ages 25 to 75 years who are seeking~     treatment for etched-in fine lines of the cutaneous lip, and/or radial cheek area, and/or~     nasolabial folds, and/or melolabial folds, and/or forehead. The purpose of this study is to~     evaluate blended Belotero for the treatment of etched-in fine facial lines and to monitor for~     adverse events.~   "
71841|NCT02626585|"~     The purpose of this study was to investigate the effectiveness of postrhinoplasty taping. The~     effectiveness was evaluated with Ultrasonography and skin envelope thickness was~     prospectively measured for analysis.~   "
71842|NCT02626572|"~     The purpose of this trial is to assess the efficacy and safety of S47445 versus placebo in~     patients with Alzheimer's disease at mild to moderate stages with depressive symptoms. An~     optional 28-week extension period will be performed to evaluate safety/tolerance and efficacy~     of S47445 in co-administration with donepezil.~   "
71843|NCT02626559|"~     Serum levels of bupivacaine over time after peri-articular injection of a mixture of~     liposomal bupivacaine and plain bupivacaine during total knee arthroplasty.~   "
71844|NCT02626546|"~     This is a multicentre, prospective, observational cohort study. Consecutive patients,~     operated in six University Hospitals in Sweden will be recruited following major surgical~     procedure. The length of patient recruitment period will be 12 weeks. The length of follow up~     will be 360 days . The objectives are to determine the postoperative morbidity (during the~     hospital stay), the survival (0-360 days), to identify risk factors for adverse outcomes and~     to identify risk factors that may potentially be influenced by any intervention in the~     future.~   "
71891|NCT02625935|"~     This multicenter, prospectively designed study examines whether the Prosigna score influences~     physician and patient adjuvant treatment selection over and above currently used prognostic~     factors. This study also examines the impact of the test results on patients' reported~     outcomes, including their decisional conflict status and anxiety levels.~   "
71845|NCT02626533|"~     Persistent pain and joint stiffness after surgery may interfere with recovery and adversely~     affect quality of life in up to 40% of patients who have undergone total knee arthroplasty.~     There is growing evidence that inflammation as well as other medical and psychological~     factors may be associated with osteoarthritis severity, progression, and associated pain~     severity. This study aims to identify clinical, biological, and psychological factors that~     contribute to and predict the development of these complications. Identification of such~     factors may allow us to target preventative measures to the patients at highest risk of~     persistent postoperative pain and joint stiffness.~   "
71846|NCT02626520|"~     Patients diagnosed with pancreatic cancer without clinically detectable metastatic disease~     will be treated with standardized systemic chemotherapy, followed by chemoradiation, and then~     surgical resection for those with resectable or borderline resectable disease. The primary~     endpoint is disease-free survival at 1 yr from initiation of treatment.~   "
71847|NCT02626507|"~     This is a dose-escalation Phase Ib clinical trial in 18 patients with newly diagnosed Stage~     I-IV ER+/HER2- breast cancer, with the primary cancer in place. These patients have not~     received prior therapy for their breast cancer and intend to undergo surgery after four~     cycles of therapy.~      This is an open-label study, and investigators and subjects are not blinded to the treatment.~     The reason for using an open-label study design is because this is a dose-escalation trial,~     and the investigators need to determine the potential toxicity before a decision can be made~     to continue the dose escalation procedures.~      The assignment of patients will not be randomized, as this is a dose-escalation trial.~   "
71848|NCT02626494|"~     This study aims at testing for the impact of glutamatergic changes on drug craving in cocaine~     addiction, and to evaluate the effects of n-acetylcysteine (n-AC) on both glutamate~     homeostasis and craving using a randomized, double-blind, placebo controlled cross-over~     design.~   "
71849|NCT02626481|"~     This study is a Multicentre, Open-label, Phase II study of Daratumumab and Dexamethasone in~     MM patients. Eligible patients must have a symptomatic RRMM with a measurable disease,~     resistant or refractory to Bortezomib and Lenalidomide and Pomalidomide.~      There is no dose escalation phase, as the MAxiamal Tolerated Dose (MTD) and drug scheduling~     have already been determined in previous phase 1-2 dose escalation studies. There is no~     randomization.~   "
71850|NCT02626468|"~     Validation of Structured Light Plethysmography (SLP) in patients with conditions such as~     Chronic Obstructive Pulmonary Disease (COPD) that effect breathing and in healthy~     participants.~   "
71851|NCT02626455|"~     The purpose of this study is to assess whether copanlisib in combination with standard~     immunochemotherapy (rituximab in combination with bendamustine [R-B] and rituximab in~     combination with a 4 drug combination of cyclophosphamide, doxorubicin, vincristine and~     prednisone/prednisolone [R-CHOP]) is effective and safe, compared with placebo in combination~     with standard immunochemotherapy (R-B or R-CHOP) in patients with relapsed iNHL who have~     received at least one, but at most three, lines of treatment, including rituximab-based~     immunochemotherapy and alkylating agents.~   "
71852|NCT02626442|"~     The risk of stroke and vascular dementia is high in individuals who have had a prior stroke~     or TIA, and in those who have vascular disease risk factors, such as high blood pressure,~     abnormal cholesterol, diabetes or pre-diabetes. These vascular risk factors can improve with~     exercise. This study will examine the impact of a 6 month, low intensity group exercise class~     on fitness, walking, balance, and brain health.~      This study will also collect fitness, walking, balance, and brain health outcome measures at~     baseline and post all other MERCE exercise and robotics interventions.~   "
71853|NCT02626429|"~     Protein requirements in active individuals have been suggested to be greater than the current~     recommended dietary allowance (RDA).~      Nutritional requirements for dietary amino acids in adults have traditionally been determined~     utilizing the nitrogen balance technique, which is prone to underestimating protein~     requirements. As a result, there is a need to re-evaluate recommendations in order to~     characterize how dietary amino acid needs may be modulated by physical activity.~      Recent studies using the minimally invasive indicator amino acid oxidation (IAAO) technique~     have suggested that protein requirements in young men are at least 50% higher than the RDA~     based on nitrogen balance data.~      The purpose of this study is to measure the protein requirement in active, young adult~     females using the IAAO technique in the presence of a variable intensity exercise stimulus.~   "
71854|NCT02626416|"~     The incidence rate of postoperative capsular opacification (PCO) in children after cataract~     surgery is reported to be as high as 100%, while timely Nd: YAG laser posterior capsulotomy~     is effective to treat visual axis opacification (VAO) caused by PCO. Therefore, long-term~     follow-up, timely diagnosis and treatment is important to improve patient's outcome.~      The major and central part of lens is easy to be observed through a dilated pupil.~     Especially, opacification in the lens and/or lens capsule is distinctive showing as white~     on the black background. The characteristic features of the disease and advances in~     photographic technique with mobile phone make it possible for patients and/or their guardians~     to monitor the progress of cataract or PCO with mobile application in a self-help manner~     under non-clinical settings.~   "
71855|NCT02626403|"~     Previous studies showed that anodal transcranial direct current stimulation (tDCS)~     transiently improves performance of memory and attention. In severely brain injured patients~     with disorders of consciousness (DOC), a single stimulation over the left dorsolateral~     prefrontal cortex has shown to improve patients' sign of consciousness. Nevertheless, other~     brain areas could be stimulated in order to increase the number of responders. In this study,~     investigators will assess the effects of bilateral fronto-parietal tDCS on Coma Recovery~     Scale-Revised (CRS-R) scores in patients with DOC in a double-blind sham-controlled~     experimental design.~   "
71892|NCT02625922|"~     This is a multicenter, randomized, double-blind, crossover, placebo-controlled, Phase II~     clinical study to evaluate the effect of serelaxin versus placebo (both in addition to SoC)~     on the release of hs-cTnI, in patients with CHF after an exercise testing session.~   "
71928|NCT02625454|"~     The investigators plan to administer acetaminophen (Tylenol) for the treatment of fever in~     laboring patients by either an oral or intravenous (IV) route. The investigators want to see~     if the maternal fever will decrease faster with the IV or the oral dose. The investigators~     also want to look at other outcomes such as the cesarean section rate, the rate of neonatal~     intensive care unit admissions in both groups.~   "
71856|NCT02626390|"~     This study examined the feasibility of using implicit and explicit learning approaches during~     gait rehabilitation in the early phase following stroke. It was a double blind trial~     (participants and assessors) using a matched pairs design. Participants were recruited from~     an acute stroke unit, and were randomised to receive gait rehabilitation over three~     consecutive days using either an implicit or explicit approach. Guidelines for each were~     developed empirically, including differences in the amount, timing, and attentional focus of~     therapists' verbal communication. Sessions were recorded and their content analysed to~     establish concordance with the guidance. Clinical measures were taken at baseline and 24~     hours post intervention using the Berg Balance Scale and the Step Test. Therapists were able~     to adhere to the guidance. Both approaches were found to be acceptable to both patients and~     therapists. The findings will be used to design an appropriately powered RCT.~   "
71857|NCT02626377|"~     Medical progress and modification of lifestyles have prolonged life expectancy, despite the~     development of chronic diseases. The support and care are often provided by a network of~     informal caregivers composed of family, friends, and neighbors. They became essential to help~     maintening the elderly persons to live at home. It has been demonstrated that the importance~     and the diversity of informal tasks may jeopardize their own physical, mental and social~     well-being.~      The aim of the Informal Carers of Elderly Cohort is to define, through a longitudinal study~     of their life course, the profiles of caregivers of patients with a diagnosis of one of the~     following diseases: cancer (breast, prostate, colon-rectum), neuro-degenerative diseases~     (Parkinson's disease, Alzheimer's and similar diseases), neuro-vascular diseases~     (Cerebrovascular Accident (CVA)), Age-related Macular Degeneration(AMD) and heart disease~     (heart failure), aged ≥ 60 years old and living in Burgundy or Franche-Comte. By following~     the different phases of the caregiving relationship from the announcement of the diagnosis,~     it will be possible to assess the quality of life of caregivers and evaluate the~     implementation of a pragmatic social action to help informal caregivers through a randomized~     intervention trial nested in the cohort.~      Thanks to an analytical and longitudinal definition of the profiles of informal caregivers,~     this study could gather precise information on their life courses and their health trajectory~     by identifying the consequences associated with the concept of their role of aid in care. In~     addition, the randomized intervention trial will explore the efficacy, in terms of quality of~     life, and efficiency of a social action to support the caregivers. These data will allow to~     identify strategies that could be used to improve the existing sources of aid and to propose~     new approaches to help caregivers. This study will provide the opportunity to identify the~     most relevant means of support and to give an impulse for new healthcare policies.~   "
71858|NCT02626364|"~     This is a proof of concept, single-arm study to investigate crenolanib monotherapy in~     patients with recurrent/refractory glioblastoma with PDGFRA gene amplification by assessing~     the progression-free survival (PFS) at 6 months. Crenolanib will be given orally starting at~     100 mg TID continuously until disease progression, unacceptable toxicity, or consent~     withdrawal.~   "
71859|NCT02626351|"~     This study evaluates the impact of a quality improvement (QI) intervention on maternal and~     child healthcare services in seven primary healthcare (PHC) clinics, in a rural setting of~     KwaZulu-Natal, South Africa.~   "
71860|NCT02626338|"~     The proposed study is designed to combine crenolanib with standard salvage chemotherapy to~     treat patients with R/R AML irrespective the FLT3 status.~   "
71861|NCT02626325|"~     High saturated fat acids diets are associated with elevated blood pressure which is~     associated with cardiovascular morbidity and mortality. For this reason, a change of diet is~     recommended to manage blood pressure and prevent cardiovascular complications. To achieve~     this nutritional goal, a high-carbohydrate diet or high-monounsaturated fat diet can be~     advised in the replacement of a saturated fat diet.~      Previous meta-analysis of Garg (1998) cited randomized articles with inconsistent blood~     pressure lowering after consumption of a high-monounsaturated-fat diet compared with a~     high-carbohydrate diet only in type 2 diabetes patients. Moreover, another meta-analysis of~     Shah et al. (2007) showed slightly high blood pressure on diets rich in carbohydrates than~     diets rich in cis-monounsaturated fat after randomized and nonrandomized articles.~      For this reason, a new meta-analysis of a randomized clinical trial will be performed to~     clarify the effects of high-carbohydrate or high-monounsaturated fat diets on blood pressure.~     Results from this meta-analysis will help health professionals take important decisions on~     patient diet and minimize cardiovascular morbidity and mortality.~   "
71862|NCT02626312|"~     The goal of this clinical research study is to find out if the new method of giving radiation~     to the liver can be given safely to patients who already have liver problems.~   "
71863|NCT02626299|"~     The purpose of this study is to determine if giving a larger amount of DHA than currently~     included in some prenatal supplements can reduce early preterm birth (birth before 34 weeks~     of pregnancy).~   "
71864|NCT02626286|"~     The objective of the study is to evaluate the feasibility and interest of a HIV quarterly~     preventive global care for men who have sex with men (MSM) in sub-Saharan Africa to help~     reducing HIV incidence in this key population, their female partners, and the general~     population. This interventional, open label, multicenter, multidisciplinary cohort study will~     be conducted in Burkina Faso, Ivory Coast, Mali and Togo.~      All participants will receive a HIV quarterly preventive global care including:~      i) data collection on health status, symptoms of sexually transmitted infections (STI) and~     sexual behavior, ii) a clinical examination, iii) STI diagnosis and treatment, iv)~     counselling adapted for MSM, and v) the provision of condoms and lubricants.~   "
71865|NCT02626273|"~     The present protocol is mainly involved in the understanding of the local interaction between~     the released products by fat tissue and hormones production of bone tissue. These complex~     interactions between adipocyte and osteocyte activities could explain the mechanisms of the~     body responses to the strategies of weight loss that include diet and/or physical activity~     program, as well as the side effects encountered by these interventions.~      Adolescence is a period of development characterized by many metabolic and somatic changes~     that may influence weight. Weights bearing physical activities are a key factor allowing body~     composition changes (i.e. fat and bone tissue). The difficulties of managing weight and the~     onset of overweight and obesity during this very important growth spurt lead to various~     hormonal dysregulation. The specific mechanisms of the evolution and interactions between~     these two parameters (fat and bone tissue) are not yet elucidated; therefore our aim is to~     analyze the possible connections between fat tissue and the quality of the skeleton in order~     to reduce related risks of the consequence of weight loss in obese individuals.~   "
71866|NCT02626260|"~     The study investigates the impact real output has on the adhesion of adhesives.~   "
71867|NCT02626247|"~     Nutrimemo aims to study the effect of a daily consumption of a mix of vitamin A and long~     chain n-3 Polyunsaturated Fatty Acids (PUFA) on the evolution of cognitive functions in~     healthy elderly subjects. The study is a randomized, double bind, parallel-groups (2 arms)~     placebo-controlled design.~   "
71869|NCT02626221|"~     This is a non-interventional, multi-country, Latin American study utilizing a prospective~     single-cohort design. Eligible CU patients will be enrolled in the study and will be followed~     for 24 months (± 6 weeks).~      In accordance with the observational nature of the study, there will be no interventions or~     interference with the routine care of the patient which will be based solely on the clinical~     judgment of the treating physician. However, with respect to the frequency and schedule of~     assessments, the schedule included in Table 7-1 will be recommended.~      The selection of the treatment for CU will be clearly separated from the decision to include~     the patient in the study, and will be made at the discretion of the treating physician in~     accordance with standard medical practice, the investigator's clinical judgment, and global~     urticarial guidelines.~      In order to prevent selection bias, investigators should offer enrollment to all consecutive~     patients meeting study criteria, likely to be available for the full duration of the~     follow-up period of 24 months, and willing to participate in the study.~      The overall objective of the study is to evaluate in real-life the CU disease burden, the~     current treatment patterns and the use of health care resources in patients refractory to~     H1-antihistamine treatment~   "
71870|NCT02626208|"~     This clinical trial investigates a new vaginal delivery system made of silicone rubber,~     containing Nestorone®, a 19—nor progesterone derivative and a low dose of serum estradiol~     (E2). The investigators plan to evaluate one-month data on the serum estradiol (E2) levels of~     three different contraceptive vaginal rings that contain a fixed dose of NES and escalating~     doses (75 µg/day, 100 µg/day, or 200 µg/day) of estradiol as the basis for selecting a CVR~     for a larger contraceptive efficacy trial.~   "
71871|NCT02626195|"~     Malnutrition patients are known to have more postoperative complications and mortality. And~     most of hepatobiliary-pancreatic cancer surgeries accompany high postoperative morbidity and~     mortality rate. Therefore for the malnourished patients anticipating major surgery,~     preoperative nutritional support is recommended according to the ASPEN (American society of~     parenteral and enteral nutrition) and ESPEN (European society of parenteral and enteral~     nutrition) guideline. However there is no prospective trial to prove the clinical impact of~     preoperative nutritional support for malnourished patients.~      The purpose of this study is to evaluate the clinical impact of preoperative nutritional~     support for malnourished cancer patients anticipating HBP surgery. Primary objective is to~     compare the complication rate and secondary object is to compare the quality of life,~     hospital stay and cost.~   "
71872|NCT02626182|"~     This study evaluates the ability of the drug sildenafil to improved exercise capacity,~     cardiac performance during exercise, and quality of life in patients with moderate to severe~     CF lung disease. 3/4 of the subjects will receive sildenafil and 1/4 will receive placebo.~   "
71873|NCT02626169|"~     Ticagrelor and clopidogrel are FDA-approved drugs for inhibition of platelet hyper-reactivity~     in certain clinical situations. The platelet inhibition and patient outcomes (PLATO) trial~     showed that in patients with acute coronary syndromes, ticagrelor significantly reduced the~     primary endpoint (cardiovascular death, myocardial infarction or stroke), all-cause mortality~     and cardiovascular mortality compared to clopidogrel. It has been suggested that in addition~     to its anti-platelet effects, ticagrelor has additional unique effects, including~     anti-inflammatory effects that are not shared by clopidogrel. In the present study the~     investigators will assess whether ticagrelor, as compared to clopidogrel, increases serum~     levels of 15-epi-lipoxin A4, a potent endogenous anti-inflammatory mediator.~   "
71874|NCT02626156|"~     The goal of this study is to test MUSTCOOL, a home-based self-monitoring and self-management~     ulcer prevention intervention for patients with newly healed chronic venous leg and diabetic~     foot ulcers. Almost 90% of ulcers recur within 3 months of healing. During the six-month~     randomized clinic trial, skin temperature will be monitored daily, a maintenance dose of~     cooling gel pack or placebo will be applied three times weekly to the affected skin, and a~     bolus dose of cooling will be applied for 5 consecutive days if skin temperature becomes~     elevated. Outcomes on the incidence of leg ulcer recurrence, pain, physical activity and~     quality of life will be measured.~   "
71875|NCT02626143|"~     This study is intended to compare growth, nutritional status, and brain development in~     children fed an Investigational cow's milk based formula containing a nutrient-rich whey~     protein, a standard cow's milk based formula, or fed exclusively breast milk.~   "
71876|NCT02626130|"~     The goal of this clinical research study is to compare the safety and effectiveness of~     tremelimumab alone and in combination with cryoablation in patients with metastatic kidney~     cancer (clear cell or non clear cell type) having surgery. Researchers also want to learn how~     the combination may affect the immune system.~      Cryoablation is a procedure that uses a hollow, thin tube called a cryoprobe to freeze and~     destroy cancer tissue.~      This is an investigational study. Tremelimumab is not FDA approved or commercially available.~     Tremelimumab is currently being used for research purposes only.~      If you are in Arm B, the cryoablation system used for your cryoablation procedure has been~     FDA-approved for use in cancer. The use of this system for metastatic kidney cancer combined~     with tremelimumab is investigational.~      Up to 30 patients will take part in this study. All will be enrolled at MD Anderson.~   "
71877|NCT02626117|"~     The concept of laser deepithelialization to retard epithelial migration has enabled new~     attachment formation in periodontal pockets. Based on this hypothesis, that laser~     deepithelialization during root coverage procedures will enhance clinical outcome, a split~     mouth randomized controlled clinical trial was planned to compare the clinical outcome of~     Coronally advanced flap (CAF) + subepithelial connective tissue graft (SCTG) alone and in~     combination with laser de-epithelialization in the treatment of gingival recession.~   "
71903|NCT02625779|"~     This research is aimed to investigate the efficacy and safety of the creatine and cytidine~     augmentation in treating bipolar depression and to evaluate changes in relevant brain~     biochemical metabolism using proton and phosphorous magnetic resonance spectroscopy.~   "
71904|NCT02625766|"~     Lateral compression type pelvic ring injuries remain the most common type of pelvic fractures~     encountered. There is a substantial amount of controversy surrounding the treatment of these~     injuries and there is evidence that both operative and non-operative treatment can be~     successful.~   "
71905|NCT02625753|"~     Compare the use of codeine/paracetamol against placebo for pain control after cornea~     photorefractive keratectomy (PRK).~   "
71878|NCT02626104|"~     This prospective, randomized, parallel-group, double blind, single-center study is to be~     conducted in the Medical University of Warsaw Public Paediatric Teaching Hospital in~     following departments: Department of Paediatric Gastroenterology and Nutrition, Department of~     Paediatrics and Nephrology, Department of Pediatric Pneumonology and Allergy, Department of~     Pediatrics with Medical Assessment Unit, Admissions Department. It is planned to include a~     total of 156 children aged between 12 months to 18 years old receiving antibiotic therapy~     because of acute respiratory tract infection/or urinary tract infection. The children will be~     randomly assigned to receive 100 mg of bovine lactoferrin or placebo twice a day orally for~     the whole period of antibiotic therapy. The primary efficacy parameter is occurrence of~     diarrhea during the antibiotic therapy and two weeks after, defined as > 3 stools a day, a~     watery or loose stool with/or occurrence of blood in the stool.~   "
71879|NCT02626091|"~     The aim of this study is to evaluate the ability of a ICG-fluorescence guidance complemented~     with enhanced reality to correctly document intestinal pre-anastomotic perfusion and to~     validate the accuracy of this technique with metabolic intestinal cells changes.~   "
71880|NCT02626078|"~     Nutrition is an essential component of health and a key determinant of aging and quality of~     life of individuals. Malnutrition in the elderly is now recognized as a public health problem~     affecting nearly half of residents in nursing homes. The fight against malnutrition requires~     to rethink the meal in all its dimensions, beyond the nutritional needs. In order to improve~     practices of care at the elderly, the impact of environmental and social aspects of food in~     nursing homes has been assessed. The social environment and interactions during the meals are~     now identified as effective ways to stimulate food intake and increase feelings of well-being~     in the elderly.~      The objectives of the study are to characterize the appreciation of food and social~     interactions during the meals and to study the relationships between the quality of food~     practices and nutritional status of the residents in nursing homes to improve their quality~     of life.~   "
71881|NCT02626065|"~     This is an open mono-centric prospective non-randomized study in patients with metastatic~     melanoma treated with Anti-PD1 monoclonal antibodies (Nivolumab). The aim of the study is to~     identify the immune cells modulations differences between patients who present a complete,~     partial or stable response and patients who have non-response to the therapy in order to~     establish an improving response rate strategy.~   "
71882|NCT02626052|"~     The purpose of this study is to explore the diagnostic values associated with both a positive~     and negative Skull Vibration Induced Nystagmus Test (SVINT) performed in room light (with~     fixation). The hypotheses include: 1. A positive room light SVINT will be identified in~     individuals with moderate to severe vestibular asymmetries. 2. A positive room light SVINT~     will be present when 10 beats or more (counted over 10 seconds) of nystagmus are found with~     fixation blocked.~   "
71883|NCT02626039|"~     Characterization of the driver mutations in an individual metastatic breast cancer patient is~     critical for many reasons. Effective targeted therapies require identifying genomic~     alterations in the tumoral tissue. The scarce efficacy of many currently available targeted~     drugs may be due to the outbreak of resistant clones with different genotype that already~     present at the initiation of therapy. It is well known the intra-tumor heterogeneity with~     genetic and non-genetic factors considered as the origin of the tumor cell-clon composition.~     The acquisition of multiple mutations (driver and passenger), altogether with the stage of~     differentiation, according to the cancer stem cell hypothesis, confers to the tumor cells~     clinically important properties, such as resistance to therapies and seeding abilities.~      Moreover, there is a current challenge in establishing whether the metastatic cells arise~     from the most aggressive and dominant clone in the primary tumor or the metastasic tissue~     diverges with substantial genetic changes very early in the evolution of the disease. Primary~     and metastatic tumor may have a close clonal relationship or evolve in parallel and acquire~     different genomic alterations. In the real life, it is plausible that both models coexist~     with different predominance according to the tumoral tissue and etiology.~      The study hypothesizes that breast cancer metastases and primary tumors could harbor~     different genomic profiles related to genomic regions of interest in a clinically relevant~     proportion of metastatic breast cancer patients.~      Moreover, the genomic aberrations found in the metastatic breast cancer tissue could also be~     detected in CTCs and circulating free DNA.~      If true, CTCs and circulating free DNA would be convenient, non-invasive, easily accessible~     sources of genomic material for the analysis of mutations and other genomic aberrations.~   "
71884|NCT02626026|"~     This study will consist of two parts: Part A will evaluate the safety, tolerability,~     pharmacokinetics (PK), and pharmacodynamics (PD) of GS-4059 in healthy participants. Part B~     will evaluate the safety, tolerability, and the effect of GS-4059 on disease-specific~     clinical markers and outcomes in participants with rheumatoid arthritis (RA).~   "
71885|NCT02626013|"~     This non-interventional study aims at assessing the impact of nab-paclitaxel on the clinical~     outcomes and the health-related QoL (HRQoL) of this heavily burdened and difficult-to-treat~     population. Notably, the data generated in the context of this study will serve as~     complementary evidence to that of the tightly and strictly controlled pre-registration~     clinical trial setting, which is of essential importance especially in patient populations~     with diseases of complex and heterogeneous biology, such as breast cancer.~   "
71886|NCT02626000|"~     A Phase 1b/3 Multicenter, Randomized, Trial of Talimogene Laherparepvec in Combination With~     Pembrolizumab for the Treatment of Subjects with Recurrent or Metastatic Squamous Cell~     Carcinoma of the Head and Neck~   "
71887|NCT02625987|"~     To compare the results associated with two different skin closure techniques in open~     appendectomy. 200 patients were included after acute appendicitis diagnosis in emergency~     department. They were grouped randomly into two groups: patients who would receive skin~     closure with skin closure by an unique absorbable intradermic stitch (Group A) and another~     that would receive a habitual technique consistent in non absorbable separated stitches~     (Group B). General characteristics like gender, age, body mass index (IMC), comorbidities and~     allergies were registered. Days of evolution (DOE) until surgery, use of antibiotics~     previously, complicated or uncomplicated appendicitis, surgery time and wound complications~     like skin infection, dehiscence, seroma or abscess were registered in each case too,~   "
71888|NCT02625974|"~     This study was designed to develop a better understanding of the efficacy,~     safety/tolerability, and pharmacokinetics (PK) (absorption, distribution, metabolism, and~     elimination) of nifurtimox in children with a diagnosis of Chagas' disease (Trypanosoma cruzi~     infection) using pediatric formulations.~   "
71889|NCT02625961|"~     In this study, participants with high risk non-muscle-invasive bladder cancer (NMIBC)~     unresponsive to Bacillus Calmette Guerin (BCG) therapy and who are considered ineligible for~     or have refused to undergo radical cystectomy, will receive pembrolizumab therapy. The~     primary study hypothesis is that treatment with pembrolizumab will result in a clinically~     meaningful response.~   "
71893|NCT02625909|"~     The aim of the study is to determine if treatment for recently acquired hepatitis C infection~     (with or without HIV coinfection) can be shortened when treating with the interferon-free~     therapy sofosbuvir/velpatasvir (SOF/VEL).~      SOF/VEL is a new treatment for hepatitis C called direct acting antiviral which targets the~     hepatitis C virus replication cycle and has been shown in phase II studies in chronic HCV to~     be highly effective (SVR12 >95%) when given for 12 weeks.~      Data has shown that treatment can be shortened when treating recently acquired HCV with~     interferon containing treatments. It is not known whether treatment with SOF/VEL can be~     shortened.~      This study aims to find out if treatment for 6 weeks with open-label SOF/VEL is equivalent to~     treatment for 12 weeks with SOF/VEL in participants with recently acquired hepatitis C~     infection. The project is a randomised study where both participants and investigators would~     not find out the treatment duration of the participants until week 6 of treatment.~   "
71894|NCT02625896|"~     This study aims to evaluate the use of an aerial human body manoeuvre to reduce the~     biomechanical load on the neck of a parachutist during the parachute opening, in order to~     create a basis for future prevention of skydiver neck pain in the parachutist population.~   "
71895|NCT02625883|"~     The investigators will retrospectively examine all patients with out-of-hospital~     resuscitation by the emergency medical Team (EMT) from the Kantonsspital Winterthur in the~     year 2013 with a one year follow-up and a structured interview about Quality of life.~     Furthermore, the costs generated by the local health system are analysed.~   "
71896|NCT02625870|"~     The trial was a double-blind, randomized, parallel-group study comparing Omega-3-Acid Ethyl~     Esters 90 Soft Capsules and placebo. The primary objective of the present study was to~     evaluate the efficacy and safety of Omega-3-Acid Ethyl Esters 90 Soft Capsules in subjects~     with severe hypertriglyceridemia (TGs ≥500 mg/dL but ＜2000 mg/dL).~   "
71897|NCT02625857|"~     The purpose of this study is to find and evaluate the recommended Phase 2 dose (RP2D) of~     JNJ-64041809, a live attenuated double deleted (LADD) Listeria monocytogenes (bacteria in~     which two virulence genes, which encode molecules that help cause disease, have been removed)~     when administered intravenously to participants with metastatic castration-resistant prostate~     cancer (mCRPC).~   "
71898|NCT02625844|"~     This study is to document the time spent by health care personnel on anemia-related tasks,~     including preparation, distribution and administration of monopegylated epoetin beta~     (Mircera) or other erythropoiesis-stimulating agents (ESAs) in patients with end stage renal~     disease in hemodialysis centers in Croatia. The total average time will be determined for the~     same number of patients on monopegylated epoetin beta and patients on other ESAs. In~     addition, qualitative information will be obtained on changes in practice patterns that may~     have occurred with the introduction of monopegylated epoetin beta.~   "
71899|NCT02625831|"~     Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by the~     production of multiple autoantibodies. Antibodies against Ficolin-3 were previously~     identified in the sera of some SLE patients, but their prevalence and significance have not~     been yet investigated. The aims of this study were to determine the prevalence of~     anti-ficolin-3 antibodies among SLE patients and to investigate their potential as diagnostic~     and/or prognostic biomarkers in SLE.~      In this retrospective study, clinical data were obtained from medical files and blood samples~     were selected from preexisting biological collection. SLE patients (n=165) were informed and~     did not objected, they were matched to healthy controls (n=48). Disease activity was~     determined according to the SLEDAI score. Anti-ficolin-3, anti-dsDNA and anti-C1q antibodies~     levels were measured in sera by ELISA. First, a highly significant difference was found in~     the anti-ficolin-3 levels between SLE patients and healthy subjects. Anti-ficolin-3~     antibodies were detected as positive in 58 of 165 (35%) SLE patients. The titer of~     anti-ficolin-3 antibodies was correlated with the SLEDAI score (p<0.0001). The presence of~     anti-ficolin-3 antibodies was associated with anti-C1q and anti-dsDNA antibodies. Regarding~     associations with clinical manifestations, only the presence of active lupus nephritis was~     significantly associated with the presence of anti-ficolin-3 antibodies (p=0.0001). This~     association with renal involvement was higher with anti-ficolin-3 antibodies than with other~     auto-antibodies. Interestingly, the combination of anti-ficolin-3 and anti-C1q antibodies~     demonstrated higher specificity than any other traditional biomarker.~      These results suggest that anti-ficolin-3 could be useful for the diagnosis of active~     nephritis in SLE patients.~   "
71900|NCT02625818|"~     A major proportion of patients admitted to psychiatric acute and emergency departments have~     symptoms, behaviors or function influenced by implicit or explicit suicidal intention~     (tendency towards self-harm, or suicide attempt). There is an increased risk of suicide in~     the acute phase during in-patient stay and after discharge. At present there is no~     satisfactory tool to predict post-discharge suicide risk.~      Multidimensional rating is expected to have better predictive properties than one-dimensional~     rating for suicidal behavior during in -patient stay and two years after discharge.~     Multidimensional rating assesses anxiety, panic, agitation, suicidal thoughts and ideations,~     as well as therapist's reactions during interviews. In the present study the predictive~     properties of two rating scales for suicidal behavior during in-patient stay and two years~     after will be compared. One of these is a multidimensional scale: Multidimensional~     Assessment of Suicide Risk (MARIS).~   "
71901|NCT02625805|"~     This study evaluates the ability to support diagnosis and monitor of the dynamics in ADD/ADHD~     subjects with an easy to use EEG Device.~   "
71902|NCT02625792|"~     SD has become a standard treatment of gastric neoplasm confined to mucosa(epithelium). But~     after procedure, formation of iatrogenic gastric ulcer is inevitable. And Post ESD ulcer~     bleeding rate reported about 5% ~ 10% of all cases. Antiplatelet or anti-coagulation~     treatment might be associated higher incidence of rebleeding after ESD and iatrogenic ulcer~     bigger than 40mm in size is also associated.~      Though several previous study have failed to show efficacy of 2nd look EGD, but those reports~     pointed out that visible vessels with current bleeding or highly suspect of recent bleeding~     (Forrest type IA~IIB) was observed about 10~20% of patients. Such patients are at high risk~     of bleeding.~      So, Investigators hypothesize that appliance of Endo-Clot(TM) at post ESD ulcer have a~     significant role of protection from gastric acidic juice and help mucosa heal earlier. Thus~     visible vessels with risk of bleeding is going to be rarely observed at 2nd look EGD. And~     finally this protective effect might have an effect for prophylaxis of post ESD ulcer~     bleeding.~   "
71909|NCT02625701|"~     There is no ideal cookbook recipe for fluid prescription that would fit every surgical~     patient.~      In this study, the investigators working hypothesis is that the adoption of an integrative~     algorithm for perioperative fluid and haemodynamic management would improve clinical outcome~     and reduce hospital resource utilization in noncardiac surgical procedures~     (major-to-intermediate level of stress.~      Two intraoperative fluid strategies will be compared: Restrictive vs. goal-directed~     therapy (GDT). In the GDT group, haemodynamic information will be obtained by a flow~     monitoring device coupled with standard heart rate and blood pressure monitoring.~   "
71910|NCT02625688|"~     Delayed cord clamping (DCC) has been a subject of extensive research for the last couple of~     years. Based on published data, numerous neonatal benefits have been suggested such as~     increased hemoglobin and ferritin levels both at birth and longer term. Available systematic~     reviews of DCC versus early cord clamping (ECC) reveal that it may also contribute to other~     neonatal outcomes including polycythemia and hyperbilirubinemia.~      A review published nearly 10 years ago regarding late umbilical cord clamping revealed only 4~     studies which as a second objective assessed whether the time of cord clamping was associated~     with an increased risk of polycythemia and hyperbilirubinemia during the first week of life.~     Two studies reported that neonates with DCC had bilirubin levels >15 mg/dl. No information is~     provided on what hour of life the bilirubin levels were measured exactly.~      In this randomized control study the investigators would like to determine if delayed cord~     clamping or cord milking during labor increases the risk of hyperbilirubinaemia (requiring~     phototherapy) in term infants.~   "
71911|NCT02625675|"~     The observational pilot study at the Churchill Hospital, funded by Oxford Respiratory Trials~     Unit, will assess the feasibility and efficacy of thoracic ultrasound (TUS) assessment in~     patients undergoing talc pleurodesis via intercostal chest drain (ICD) for recurrent~     symptomatic malignant pleural effusions (MPE). Participants will undergo TUS pre and post~     pleurodesis on up to four occasions. We hypothesise that a TUS scoring system will be able to~     predict short and long-term pleurodesis success earlier than current conventional medical~     practice allows. This study may ultimately allow the proposal of a treatment algorithm to~     manage patients with MPE in a more efficient manner.~   "
71912|NCT02625662|"~     This study will focus on the symptoms, natural history and clinical impact of~     facioscapulohumeral muscular dystrophy (FSHD) in children.~      Symptoms of classical FSHD start in adulthood. However, a small subgroup of FSHD patients~     have an early, childhood onset. This early onset is associated with faster progression and~     other symptoms like hearing loss and epilepsy.~      The symptoms, natural history and clinical impact of FSHD in children are largely unknown.~      The results of this study will be vital for adequate symptomatic management and~     trial-readiness.~   "
71913|NCT02625649|"~     This study evaluates the long-term benefits of Roux-en-Y gastric bypass (RYGB) on type 2~     diabetes mellitus, focussing on the prevalence and predictors of T2DM improvement and~     remission after RYGB, and subsequently relapse of type 2 diabetes mellitus after RYGB.~     Moreover, the study evaluates the possible effect of RYGB on diabetic microvascular~     complications such as nephropathy and retinopathy. Finally, the study provides insight into~     the factors influencing glucose-insulin homeostasis after RYGB, including altered microbiota~     diversity and bile acid levels.~   "
71914|NCT02625636|"~     Primary Objective:~      To assess the tolerability and safety of SAR438544 after single ascending subcutaneous (SC)~     doses in healthy subjects and in type 1 diabetes mellitus (T1DM) patients.~      Secondary Objective:~      To assess the preliminary pharmacodynamics (PD) and pharmacokinetic (PK) parameters of~     SAR438544 after single ascending SC doses in healthy subjects and in T1DM patients.~   "
71915|NCT02625623|"~     The purpose of this study is to demonstrate superiority of treatment with avelumab plus best~     supportive care (BSC) versus physician's choice (chosen from a pre-specified list of~     therapeutic options) plus BSC.~   "
71916|NCT02625610|"~     The purpose of this study is to demonstrate superiority of treatment with avelumab versus~     continuation of first-line chemotherapy.~   "
71917|NCT02625597|"~     The primary purpose of this study is to determine what effect, if any, do different dental~     materials used to seal the prosthetic screw channels of implant supported restorations have~     on dental implant health parameters and microbiology.~   "
71918|NCT02625584|"~     The aim of this project is to determine how shared reading promotes child language~     development, and to use this knowledge to make it an effective language-boosting tool for~     children from all social and economic backgrounds.~   "
71919|NCT02625571|"~     A significant minority of children (ages 5-12) display problematic sexual behavior and the~     persistence of this behavior is oftentimes as stable as other child behavior problems, such~     as aggression and defiance. Unfortunately, the only tested intervention protocols for these~     concerns utilize a group treatment modality that is not feasible in most community treatment~     settings. This project will define and pilot test an intervention for child sexual behavior~     problems that is applicable in most settings and can be easily disseminated as a first step~     toward validation in larger clinical trials.~   "
71920|NCT02625558|"~     Double blind placebo controlled trial of riociguat for sarcoidosis associated pulmonary~     hypertension~   "
71921|NCT02625545|"~     The purpose of this study is to evaluate the safety and effectiveness of using UroLift in~     subjects with a prostatic median lobe enlargement due to BPH.~   "
71922|NCT02625532|"~     Exploratory, prospective, randomized, comparative, open trial with control group treated to~     assess the efficacy of follicular phase ovarian stimulation compared to lutheal phase ovarian~     stimulation in women with Bologna criteria for poor ovarian response.~   "
71923|NCT02625519|"~     Exploratory, prospective, randomized, comparative, open trial with control group treated to~     assess whether the effective use of urinary FSH (uFSH) or recombinant FSH (rFSH) can be~     influenced by genotype of receptor N680S FSH Gene Polymorphism.~   "
71924|NCT02625506|"~     The aim of this study is to evaluate the addition of tramadol combined with levobupivacaine~     in the reduction of postoperative pain, postoperative opioid consumption after modified~     radical mastectomy surgery.~   "
71925|NCT02625493|"~     The purpose of this study is to determine the preference of patients regarding the vascular~     access site in future coronary procedures. We hypothesize that patients prefer the lesser~     invasive procedure via radial access.~   "
71929|NCT02625441|"~     This randomized clinical trial compares two systemic treatments for HER2-positive breast~     cancer. The treatments are given either prior to breast surgery (as neoadjuvant treatment) or~     after breast surgery (as adjuvant treatment). In the investigational group (Group A) the~     study participants will receive a combination of two drugs directed at HER2 (two anti-HER2~     antibodies) plus a chemotherapy agent (docetaxel) for a brief duration, and the patients~     allocated to the comparator group (Group B) will be treated with chemotherapy plus one~     anti-HER2 treatment (trastuzumab) for one year.~   "
71930|NCT02625428|"~     This is a pilot study to investigate whether contrast-enhanced ultrasound (CEUS) may help~     evaluate segmental differences in renal perfusion better than Doppler Ultrasound and thus~     help direct the biopsy to the most abnormal part of the renal cortex. This should maximize~     detection and increase the odds of demonstrating the true grade/severity of the~     histopathological abnormality.~   "
71931|NCT02625415|"~     The study is designed to test the effectiveness of topical B6 cream in patients that~     developed Palmar-Plantar Erythrodysesthesia (Hand foot syndrome).~   "
71932|NCT02625402|"~     This pilot RCT study is to examine the comparative effectiveness of two decision aids for hip~     and knee osteoarthritis.~   "
71933|NCT02625389|"~     This study is multicenter (up to 10 sites in India) phase IV Post-Marketing Study. The study~     is designed to investigate the safety of Lipiodol® Ultra Fluid in association with surgical~     glues used according to each site medical practice of vascular embolization. Subjects will be~     enrolled with the main condition that a procedure of vascular embolization using Lipiodol®~     Ultra Fluid in association with surgical glues is part of their therapeutic/palliative~     strategy for their disease. The vascular embolization using Lipiodol® Ultra Fluid in~     association with surgical glue will be administered as study procedure. According to the~     patient need and health status a second vascular embolization using Lipiodol® Ultra Fluid in~     association with surgical glue may be considered by the investigator within the next 30 days~     after the first one. In this case, this procedure will be considered as a second study~     procedure. The per-procedure safety evaluation will be enabled by appropriate records of~     safety events during the time frame of the procedure of vascular embolization using Lipiodol®~     Ultra Fluid in association with surgical glues. Safety evaluation will be completed with~     safety records within 30 +/-3 days after the embolization procedure. Efficacy evaluation will~     rely on the level of lesion(s) obliteration after embolization compared to the pre-procedural~     target level of obliteration. Exploratory descriptive statistical methods will be used to~     evaluate safety and efficacy, using both the total population and subsets of subjects with~     similar clinical conditions.~   "
71934|NCT02625376|"~     This is an interventional, prospective, randomized, comparative monocentric study aiming to~     evaluate the safety and efficacy of Resveratrol to reduce the progression of exudative~     Age-Related Macular Degeneration.~   "
71935|NCT02625363|"~     Glycemic index concept is widely used to determine impact of a food to blood glucose. Several~     studies showed that water content and intake after meal may influence glycemic response of~     the meal and thus have an effect on the result of GI measurement. Currently these studies~     found conflicting results. Therefore, this study aims to determine whether water intake,~     specifically after meal, may influence the glycemic response and glycemic index value of the~     meal.~   "
71936|NCT02625350|"~     Glycemic index is commonly used as a method to determine the effect of a food to blood~     glucose. Despite its carbohydrate and fat content, instant noodle is very popular in Asia,~     including Indonesia. Based on the serving method, there are instant noodle without and with~     soup. Studies have shown that water content of a meal may influence glycemic response of the~     meal and thus have an effect on the result of GI measurement. However none specifically~     studied instant noodles nor the additional water content as soup (not incorporated in the~     food matrix). Therefore, this study aims to determine whether the serving method of instant~     noodle (with and without soup) may influence the glycemic response and glycemic index value~     of the meal.~   "
71937|NCT02625337|"~     This is a Phase 2 trial consisting of 24 patients receiving the combination of dabrafenib +~     trametinib + pembrolizumab in 3 different dosing schemes and 8 patients receiving~     pembrolizumab standard monotherapy. All patients start with pembrolizumab standard therapy~     for 6 weeks and will then be randomized to continue pembrolizumab monotherapy or to receive~     additional intermitted/short-term dabrafenib + trametinib.~      Stratification will be baseline LDH level and baseline PD-L1 expression.~   "
71938|NCT02625324|"~     The purpose of the Valiant Evo International Clinical Trial is to demonstrate the safety and~     effectiveness of the Valiant Evo Thoracic Stent Graft System in subjects with a descending~     thoracic aortic aneurysm (DTAA) who are candidates for endovascular repair. The Valiant Evo~     International Clinical Trial is a first-in human experience with the objective to provide~     clinical data for supporting CE marking via case series and descriptive statistics.~   "
71939|NCT02625311|"~     Randomized clinical trial comparing minimal invasive operating technique to conventional~     operating technique for placement of total knee prosthesis.~      Clinical evaluations, patient questionnaires, X-rays and CT scans were done to compare these~     two techniques.~   "
71940|NCT02625298|"~     Traumatic tooth injuries are common in children and adolescents, and often result in pulpal~     necrosis and the development of periapical lesions. Treatment of traumatized teeth with~     endodontic complications depends on the type of injury, number of injured teeth, root~     development and patient cooperation, which altogether will create a challenge and dictate the~     treatment plan for the dentist. The purpose of this study was to assess the effectiveness of~     non-surgical root canal procedures in traumatized permanent teeth with necrotic pulps and~     chronic periapical lesions using a tri-antibiotic paste and calcium-hydroxide as intracanal~     medications and two different mineral trioxide aggregate (MTA) products for definitive~     obturation.~   "
71941|NCT02625285|"~     This is a laboratory research to evaluate performances of quantitative POC G6PD tests~     (Biosensors) against gold standard quantitative laboratory based tests and genotyping.~   "
71942|NCT02625272|"~     The purpose of this study is to determine the short and long outcomes of the novel technique~     of hand-assisted laparoscopic right hemicolectomy with complete mesocolic excision and~     central vascular ligation for right colon cancer.~   "
72785|NCT02614248|"~     The purpose of the study is to examine the safety and effectiveness of the use of coconut oil~     for the prevention and treatment of diaper dermatitis among NICU babies at Genesis Medical~     Center, Davenport.~   "
71943|NCT02625259|"~     The purpose of this study is to evaluate the relative bioavailability of a new tablet~     formulation of TAK-117 (new clinical trial material [NTM]) compared to the TAK-117 Process B~     capsules (current clinical trial material [CTM]) (Part 1), to assess the effects of food on~     the oral bioavailability and pharmacokinetics (PK) of TAK-117 (Part 2), and to assess the~     effects of gastric pH-modifying agent on the PK of TAK-117 in healthy participants (Part 3).~   "
71944|NCT02625246|"~     To demonstrate the safety of bone marrow-derived allogeneic human Mesenchymal Stem Cells~     (hMSCs) in patients with bronchiectasis receiving standard of care therapy, and to explore~     treatment efficacy~   "
71945|NCT02625233|"~     This is a multi-site, dispensing, 4-visit, 2-arm parallel group, randomized, double-masked~     clinical trial using a Vistakon investigational contact lens (test) and a marketed monthly~     replacement contact lens (control). Each subject will be assigned randomly to either the test~     or control lens to evaluate the long term safety and efficacy of the investigational contact~     lens compared to the marketed contact lens over a period of six months of lens wear.~   "
71946|NCT02625220|"~     Non-randomized, single-masked, 2-visit, bilateral wear, single-arm dispensing study to~     evaluate the visual acuity, rotational performance, lens fit, stability and subjective~     characteristics of a senofilcon-based JJVCI investigational toric contact lens design.~   "
71947|NCT02625207|"~     This will be an open-label, parallel group, multiple dose study in approximately 48 healthy~     male or female subjects of African American and Caucasian self-reported race, to assess the~     effect of CYP3A5 genotype on the PK of MVC and CYP3A5-derived metabolites. Maraviroc and~     CYP3A5-derived metabolite PK will also be compared between African-Americans and Caucasians~     in subjects carrying two copies of the dysfunctional CYP3A5 alleles (*3, *6, and/or *7).~   "
71948|NCT02625194|"~     This study investigate the utility of continuous oxygen insufflation during fiberoptic~     bronchoscope-guided intubation.~      One group receives oxygen via suction channel of fiberoptic bronchoscope during intubation.~      The other group does not receive oxygen during fiberoptic bronchoscope-guided intubation.~      Then, the velocity of deoxygenation difference of PaO2(baseline~   "
71949|NCT02625181|"~     The purpose of this study is to determine how automated recommendations are best presented to~     optimize the adherence to guidelines on prophylaxis for nausea and vomiting after surgery.~   "
71950|NCT02625168|"~     The investigators prospectively evaluated in this study the efficacy and safety profiles of~     afatinib as 3rd or 4th line treatment after prior failure to systemic chemotherapy and~     first-generation EGFR-TKI under a Boehringer Ingelheim sponsored Compassionate Use Program~     (CUP), with comparison of our historical cohort who received erlotinib after previous failure~     to systemic chemotherapy and first-generation EGFR-TKI.~   "
71951|NCT02625155|"~     The purpose of this study is to determine whether the addition of selective pharmacogenomic~     (PGx) testing as determined by Urine Drug Testing (UDT) adds a clinical benefit as evidenced~     by a reduction in Target Drug-related Adverse Events (TDRAE) over the period following~     enrollment.~   "
71952|NCT02625142|"~     The goal of this study is to develop, implement, and evaluate the effectiveness of an~     intervention designed to facilitate family engagement during bedside rounds at a children's~     hospital. The intervention consists of a checklist of key behaviors associated with the~     delivery of quality family-centered rounds, as well as training in the use of the checklist~     tool. In a pre-post controlled design, two hospital services will be randomized to use the~     checklist while two others will be randomized to usual care. The intervention is expected to~     increase to the performance of key checklist behaviors, family engagement, and family~     perceptions of patient safety.~   "
71953|NCT02625129|"~     This study will evaluate the clinical effectiveness of, and patient satisfaction with,~     pre-travel consultations provided by a pharmacist with specialty training in travel medicine~     and the authorization to prescribe medications and administer vaccinations.~   "
71954|NCT02625116|"~     The objective of the ELENA French Cohort is to study the developmental trajectories of~     children and adolescents with ASD and their risk or protective associated factors.~      This is an open, prospective and multicenter cohort study, including children and adolescents~     under 16 years of age with ASD recruited from services specialized in the assessment of~     developmental disorders.~   "
71955|NCT02625103|"~     The role of Therapeutic Drug Monitoring (TDM) in clozapine dose adjustment have been debated.~     Blood samples for s-clozapine monitoring should be drawn 12 hours post dose.~      The scope of this trial is to describe changes of s-clozapine and s-N-desmethyl-clozapine~     within the range of 10-14 hours after the last administration of clozapine .~   "
71956|NCT02625090|"~     The purpose of study EP0073 is to assess the long-term safety, tolerability, and efficacy~     during 5 years of treatment with the drug UCB0942 in patients with highly drug-resistant~     focal epilepsy. Also, the effects of UCB0942 on the patient's quality of life will be~     explored.~   "
71957|NCT02625077|"~     This monocenter randomized controlled trial aims to compare postoperative outcomes of a~     laparoscopic valvuloplasty with a Toupet fundoplication in patients with GERD with a maximum~     hiatal hernia of 3cm. In addition, an economic evaluation of the new intervention will be~     done in order to determine cost-effectiveness and costs per quality-adjusted life-year~     (QALY).~   "
71958|NCT02625064|"~     The goal of this project is to find a series novel biomarkers by differential proteomic~     techniques that can improve the early diagnosis and develop a more efficient therapy to~     enhance ARDS patient survival rate.~   "
71959|NCT02625051|"~     This is a prospective randomized study, comparing quality of life in renal stone patients~     undergoing surgical treatment with ureteroscopy (URS) versus percutaneous nephrolithotomy~     (PNL).~   "
71960|NCT02625038|"~     Target of the study is to evaluate the reduction accuracy of 3D computer-planned osteotomies~     that are performed with patient-specific instruments.~      Due to the higher accuracy achieved it is expected that complaints can be resolved or~     effectively revealed. The Research hypothesis to prove is The medical product permits the~     surgical reduction of deformed bones of the hand and forearm (radius, ulna, distal humerus,~     carpal, metacarpal, and finger bones) by corrective osteotomy within an accuracy of 2 mm and~     2º. Secondary outcome is an assessment of the surgical outcome using the Disabilities of the~     Arm, Shoulder and Hand (DASH) and the Patient related wrist Evaluation (PRWE) scores.~   "
71961|NCT02625025|"~     During laparoscopy pneumoperitoneum creates the necessary space in which to perform the~     operation. Growing evidence in general surgery has shown that reduction of intra-abdominal~     pressure during laparoscopy is related to improved postoperative outcomes, decreased pain~     perception, length of hospital stay, and analgesic rescue dosage in patients undergoing~     minimally invasive procedures using low pneumoperitoneum pressure (LPP) compared with~     standard pneumoperitoneum pressure (SPP). Aim of the study is to demonstrate the safety and~     feasibility of LPP during performance of Single Port Access Laparoscopy for benign adnexal~     pathologies.~   "
71962|NCT02625012|"~     Vitiligo is the most common acquired depigmented disorder of the skin characterized by~     destruction of melanocytes resulting in well-circumscribed achromic macules. Ultraviolet~     phototherapy with narrow band (UVB-NB) is currently one of the treatments of choice, because~     it is able to induce proliferation, differentiation, maturation and migration of melanocytes.~     This repigmentation has distinctive patterns such as follicular, marginal, and diffuse. The~     aim of this study is to observe the dynamics of migration and proliferation, in vitiligo~     patients under UVB radiation phototherapy treatment. The investigators will evaluate this~     process by measuring FAK (focal adhesion kinase ) and c-Kit by immunohistochemistry and~     reverse transcriptase polymerase chain reaction assay.~   "
71963|NCT02624999|"~     Phase II, Randomized, Non-Inferiority Study Comparing an Individualized Cancer Vaccine~     (AlloVax™) to Chemotherapy in Subjects with R/M SCCHN .~   "
71964|NCT02624986|"~     This is a open-label, mutlicenter, non-randomized, study to evaluate the safety, efficacy,~     and pharmacokinetics of idasanutlin in combination with obinutuzumab in participants with R/R~     FL and rituximab in combination with idasanutlin in R/R DLBCL. The study will include an~     initial dose-escalation phase followed by an expansion phase. The dose-escalation phase is~     designed to determine the recommended phase 2 dose (RP2D) for idasanutlin in combination with~     obinutuzumab for FL and in combination with rituximab for DLBCL. The expansion phase is~     designed to further assess the safety and efficacy of obinutuzumab in combination with~     idasanutlin at the RP2D with the selected regimen in participants with R/R FL and of~     rituximab in combination with idasanutlin at the RP2D in participants with R/R DLBCL.~   "
71965|NCT02624973|"~     Breast cancer is an optimal model disease for studying personalized medicine. Breast cancer~     was the first malignancy for which a predictive factor forecasting response to therapy was~     identified nearly 50 years ago; the expression of the estrogen receptor (ER). Furthermore,~     breast cancer is by far the malignancy in which prognostic and predictive factors have been~     most extensively studied. Primary medical treatment (pre-surgical medical therapy) offers a~     unique setting to explore predictive factors due to the fact that primary breast cancers are~     easily accessible to repeated tissue sampling and evaluation of therapy response both~     clinically and radiologically. For many years, the investigators have studied predictive~     factors in primary medical treatment of breast cancer. In the present project, the~     investigators will implement a new trial concept where the current knowledge from previous~     trials with respect to predictive markers (hormone receptors, HER2; TP53, CHEK2 and RB1),~     will be combined with massive parallel sequencing (MPS). Thereby, the investigators aim to~     design the next-generation primary medical treatment where 1) therapy regimens are~     individualized based on a limited number of known predictive factors and, 2) MPS is used to~     explore additional predictive factors and their co-regulators in order to fully identify the~     mechanisms of drug sensitivity / resistance across individual tumours and pave the way for~     further personalized breast cancer therapy in the future. As for the new era of genomic~     medicine, the current trial concept will allow individual tumours to be characterized by~     their unique gene mutation / epigenetic modification profile upfront, to allocate patients to~     their optimal personalized medicine as compared to classical drug testing through phase~     II/III trials.~   "
71966|NCT02624960|"~     This is a single-arm, multi-center, open-label controlled study that will assess the safety~     and performance of the Accucinch System to induce left ventricular reverse remodeling and~     reduce the severity of functional mitral regurgitation in symptomatic adult patients with~     mitral regurgitation and left ventricular remodeling due to dilated cardiomyopathy (ischemic~     or non-ischemic etiology), who are of high operative risk.~   "
71967|NCT02624947|"~     The purpose of this study is to determine the efficacy of maternal immunization with the RSV~     F vaccine against symptomatic RSV lower respiratory tract infection (LRTI) with hypoxemia~     through the first 90 days of life in infants.~   "
71968|NCT02624934|"~     Aortic stenosis is a major cause of morbidity around the world. Progressive aortic stenosis~     leads to cardiac hypertrophy as a compensatory response. A maladaptive response may lead to~     heart failure at varying degrees of severity of aortic stenosis in individual patients. The~     predicting factors for the occurrence of a maladaptive response are not well defined.~     Therefore current medical therapy for aortic stenosis is considered insufficient and may~     actually cause harm. The only effective therapy for severe, symptomatic aortic stenosis is~     aortic valve replacement. It has been found in an experimental study that Podocan determines~     the degree of cardiac hypertrophy in response to pressure overload via the Wnt-pathway. The~     possible prognostic role of secreted circulating Wnt modulators in aortic stenosis has also~     recently gained attention. This project will attempt to establish the prognostic role of~     circulatory Podocan and Wnt modulators for maladaptive left ventricular response to aortic~     stenosis. This may help identify patients at particular risk to develop left ventricular~     dysfunction with aortic stenosis and improve understanding of the mechanisms of left~     ventricular remodeling in aortic stenosis. Hence, this may also later act as an important~     background in finding more effective therapies to prevent or delay maladaptive left~     ventricular response in aortic stenosis.~   "
71989|NCT02624648|"~     Objective: To study the effects of Lepidium Meyenii in sexual function of postmenopausal~     women.~      Method: It will be held a clinical, prospective, randomized, double-blind, placebo-controlled~     study with 144 postmenopausal women with sexual dysfunction, treated at Menopause Clinic at~     the Faculty of Medical Sciences of Santa Casa de São Paulo and in the Vale do Sapucai~     University. All women sign the Consent Form Term. The study will be conducted in accordance~     with the protocol and principles of the Declaration Helsinki (Version 1996), according to~     International Conference on Harmonization and Tripartite Guidelines for good clinical~     practice and regulatory requirements. The protocol was approved by the Ethics Committee of~     the Faculty of Medical Sciences of Santa Casa de São Paulo.~      Hypothesis: It is expected to be an improvement of sexual function in postmenopausal women.~   "
71969|NCT02624921|"~     The study aimed to explore therapeutic effects of natural environments. To do so, the~     investigators evaluated the immediate and sustained changes in several indicators of~     well-being while people (n=26) with poor mental health were engaged in unconstrained~     exposures to natural (green, blue) and urban environments. The indicators included:~     affection, cognition, physiological responses.~      Each participant was exposed to all environments for a period of 210 minutes between October~     2013 and January 2014. During the exposure period, participants were instructed to do what~     they would usually do in that environment. Before, during (at 30 and 210 minutes) and after~     each exposure, several psycho-physiological measures were taken: (i) heart rate variability~     and heart rate using a Holter monitor, (ii) blood pressure using a digital blood pressure~     monitor, (iii) physical activity using the CalFIT application installed in a Smartphone, (iv)~     lung function using a portable computerized spirometer, (v) stress level using salivary~     cortisol samples collected using Salivettes, (vi) affect, perceived restoration and social~     interactions using questionnaires, (vii) cognitive functioning using the backwards digit-span~     task test.~   "
71970|NCT02624908|"~     24-week, randomized, double blind, placebo-controlled trial to evaluate safety and efficacy~     of canagliflozin as compared with placebo in reducing the need for mealtime insulin in~     subjects with type 2 diabetes currently using a basal-bolus insulin regimen.~   "
71971|NCT02624895|"~     This is a national, multicentric, prospective, observational trial. The decision to prescribe~     FOLFOX or FOLFIRI plus panitumumab or FOLFOX or FOLFIRI plus cetuximab must have been freely~     taken by the clinician prior to the study entry for each patient included. Each physician~     will see his/her patients within the context of routine visits, without any special visit~     being organised for the purposes of the study. Therefore, the doctor-patient relationship and~     patient follow-up are not modified. Physicians are totally free to decide on their patients'~     therapeutic management.~      EORTC QLQ-C30 and DLQI questionnaires will be completed by the patients at baseline (Day 1 of~     Cycle 1), at the first day of every other cycle (every 2 weeks) thereafter, and at end of~     treatment visit (28 days (+/- 3 days) from the last cycle). Questionnaires should be~     completed at the start of the visit, before any study related procedure is done.~      Before every cycle, adverse events will be recorded and graded according to NCI CTCAE v4.0.~     Treatment's modifications in terms of cycles' delay, dose reductions or drugs' interruptions~     will be recorded.~      Concomitant approaches to prevent or treat dermatological toxicities during the treatment~     will be registered.~   "
71972|NCT02624882|"~     Single-center prospective study to assess the clinical course of group A streptococcal~     blistering distal dactylitis in children after antibiotic treatment.~   "
71973|NCT02624869|"~     To describe the safety and tolerability of 80 weeks of subcutaneous (SC) evolocumab (AMG 145)~     when added to standard of care in pediatric subjects 10 to 17 years of age with HeFH or HoFH.~   "
71974|NCT02624856|"~     The purpose of this study is to compare the efficacy and duration of pain relief after total~     knee arthroplasty provided by a single injection of liposomal bupivacaine (EXPAREL®) versus~     standard bupivacaine with an adjuvant, dexamethasone when administered as a quadriceps~     sparing femoral nerve block and periarticular injection. It is hypothesized that liposomal~     bupivacaine is superior to standard bupivacaine with dexamethasone and will decrease time to~     discharge readiness.~   "
71975|NCT02624843|"~     To establish the therapeutic equivalence and safety of a generic Benzyl Alcohol Lotion 5%~     with Ulesfia Lotion 5% in eradication of head lice in the study subjects.~   "
71976|NCT02624830|"~     The purpose of this study is to investigate long term response of sulfonylurea and glucose~     control in children with diabetes due to mutations in ABCC8 that have been switched from~     insulin injections to sulfonylurea tablets.~   "
71977|NCT02624817|"~     The purpose of this study is to investigate long term response of sulfonylurea and glucose~     control in children with diabetes due to mutations in KCNJ11 that have been switched from~     insulin injections to sulfonylurea tablets.~   "
71978|NCT02624804|"~     This is a prospective, single arm, open-label, single-center pilot study to assess the~     safety, feasibility, and efficacy of Stem Cell Educator therapy for the treatment of patients~     with Type 1 Diabetes.~   "
71979|NCT02624791|"~     Small amounts of astigmatism are often uncorrected in contact lens wearers. The effect with~     respect to driving is unknown, but it could threaten safe operation of a motor vehicle,~     especially under conditions such as nighttime driving when visual abilities are highly~     challenged. This study measures driving-specific visual abilities and simulated driving~     performance in participants with astigmatism who either have or do not have their astigmatism~     corrected. The primary hypothesis is that at a tactical level, contact lenses correcting for~     astigmatism will result in safer driving performance overall. The secondary hypothesis is~     that at an operational level, contact lenses correcting for astigmatism will result in better~     driving-specific visual performance.~   "
71980|NCT02624778|"~     The study will evaluate the effect of LY3002813 on brain scans. The study will evaluate the~     safety of LY3002813 by looking at adverse events (side effects). The study will also look at~     the effect the body has on LY3002813. Study participants will have mild cognitive impairment~     (MCI) due to AD or mild to moderate AD.~      The study involves 3 parts.~        -  Part A in which participants will receive a single dose of LY3002813 or placebo (no~          drug).~        -  Part B in which participants will receive multiple doses of LY3002813 or placebo for 24~          weeks.~        -  Part C in which participants will receive multiple doses of LY3002813 or placebo for up~          to 72 weeks.~      Drug will be given as an intravenous infusion (injection into a vein). For Parts A, B and C,~     the study will last approximately 72 weeks, not including screening of approximately 56 days.~     The study is for research purposes only and is not intended to treat any medical condition.~   "
71990|NCT02624635|"~     The purpose of this study is to compare the effects of manual therapy and of manual therapy~     associated with hip strengthening in the recovery of patients with heel pain.~      Heel pain decreases function, balance, walking and can cause change in the movement pattern.~     This alterations can induce a deficit in motor control of other structures as knee and hip.~     There is an importance to compare the effects of manual therapy and manual therapy associated~     with hip strengthening on the recover of patients with heel pain.~   "
72786|NCT02614235|"~     The purpose of this study is to determine whether continuous cardiac telemetry with the~     Pocket-ECG III® system is more useful than conventional Holter to find out the cause of~     syncope~   "
71981|NCT02624765|"~     Few studies are specifically designed to address health concerns relevant during pregnancy.~     The consequence is a lack of evidence on best clinical practice. This includes mothers and~     their babies when pregnancy is complicated by an abnormally fast heart rate up to 300 beats~     per minute due to supraventricular tachyarrhythmia (SVA) in the unborn baby (fetus). Although~     fetal SVA, including atrial flutter (AF) and other forms of supraventricular tachycardia~     (SVT), is the most common cause of intended in-utero fetal therapy, none of the medication~     used to date has been evaluated for their effects on the mother and her baby in a randomized~     controlled trial (RCT). As a consequence, physicians need to make decisions about the~     management of such pregnancies without any evidence from controlled trials on drug efficacy~     and safety and no consensus among specialists for the optimal management. The Fetal Atrial~     Flutter and Supraventricular Tachycardia (FAST) Therapy Trial is a prospective multi-center~     trial that addresses this knowledge gap to guide future fetal SVA therapy to the best of~     care. Study components of FAST include three prospective sub-studies to determine the~     efficacy and safety of commonly used transplacental drug regimens in suppressing fetal AF~     without hydrops (RCT A), SVT without hydrops (RCT B), and SVT with hydrops (RCT C). All RCTs~     are open label phase III trials of standard 1st line therapy, which either is started as~     monotherapy (no hydrops) or as dual therapy (hydrops). The primary study aim is the~     probability of a normal pregnancy outcome after treatment start with Digoxin or Sotalol (AF~     without hydrops); Digoxin or Flecainide (SVT without hydrops); and Digoxin plus Sotalol or~     Digoxin plus Flecainide (SVT with hydrops).~   "
71982|NCT02624752|"~     The purpose of this pilot study is to determine the effect of 3 months use of enhanced Oral~     Nutritional Supplement (ONS) on physical function and functional performance in malnourished~     elderly patients.~   "
71983|NCT02624726|"~     Investigators propose to study the combination of m FOLFIRI plus Aflibercept in a Phase II~     trial of patients with metastatic colorectal cancer. The promising results of aflibercept~     derived from preclinical studies and from clinical trials conducted in patients with~     refractory of recurrent to oxaliplatin-based 1st line treatment in patients with mCRC open~     the field to explore such therapeutic approaches in the 1st line setting in combination with~     the FOLFIRI regimen.~   "
71984|NCT02624713|"~     Randomized Clinical Trial, the research will be composed of two parts in order to examine the~     research question: a combination of controlled randomized retrospective research and~     prospective cohort research~      Prospective Cohort Research:~      The research groups - families coming for treatment in Active Maccabi clinics in the~     Northern Region, Israel. Approximately 30 families.~      Retrospective Random Controlled Research~        1. The research group - families that have completed an intervention program of Active~          Maccabi Northern Region, Israel,within the past two to three years. The families will~          be requested to attend a follow-up meeting of all family members in which they will~          answer questionnaires. Approximately 66 families.~        2. The control groups - families who did not participate in the program who have a child~          between the age 7-14 who has suffered from obesity/weight (over the past 2-3 years), in~          correlation with the child in the intervention group. Approximately 66 families.~      Hypotheses of the research:~        1. Status of the weight of the child being treated and of his siblings will be higher than~          that at the end of the program.~        2. Indication of the obesogenic environment of families participating in the program will~          be lower in comparison with families not participating in the program.~        3. The rate of eating disorder symptoms among children who participated in the program will~          be lower in comparison with those of the obese/overweight child in families who were not~          the program.~        4. The rate of eating disorder symptoms among siblings who participated in the program will~          be lower than that of siblings in families not in the program.~   "
71985|NCT02624700|"~     This phase 2 clinical trial will evaluate the efficacy of the combination of pemetrexed and~     sorafenib in patients with recurrent or metastatic Triple Negative Breast Cancer (TNBC).~     Candidate pharmacodynamic and predictive biomarkers will also be evaluated.~   "
71986|NCT02624687|"~     This study will test the effects of a sedentary behavior intervention on low back pain in~     working adults. The behavioral intervention will include the use of a sit-stand desk and a~     wrist-worn activity prompter that will notify participants when they have been sedentary for~     too long.~   "
71987|NCT02624674|"~     Peripheral vascular disease (PVD) is a common disease of impaired blood flow resulting in the~     compromised tissue perfusion of lower limbs. PAD patients can experience pain, diminished~     exercise capacity, and tissue loss, with some ultimately requiring amputation. The economic~     burden of PVD is significant. In the United States alone, PVD accounts for over $20 billion~     in annual healthcare related costs.~      The demand for the development of an effective method to characterize the viability of PVD~     wounds has resulted in the emergence of several innovative techniques. Commonly used~     diagnostic methods are ankle-brachial index (ABI), pulse volume recordings, duplex~     ultrasonography, venous plethysmography, Transcutaneous oxygen tension (TcPO2), toe~     pressures, angiography by X-ray, computed tomography, and magnetic resonance imaging.~     Currently, angiography remains the diagnostic gold standard. However, many of these~     techniques lack the ability to triage and adequately determine the viability of the wound. In~     addition, there remains a need for effective triage technologies to help clinicians decide~     whether surgical management is needed. Early determination of surgical versus conservative~     management may help to improve patient functional outcomes, reduce mortality rates, and~     prevent limb amputation.~      Near-infrared point spectroscopy (NIRS) is a non-invasively technology with recent~     applications in PVD wound assessment. To date, studies have demonstrated the validity of NIRS~     technology in patients with peripheral arterial disease. NIRS measures flow, concentration,~     and oxygenation of hemoglobin in arterioles, capillaries, and venules several centimeters~     deep in tissue. The MSID is an evolution of existing NIRS imaging devices and has become a~     portable and functional commercial device produced by KENT imaging (Calgary, Canada). Using~     this new and clinically applicable NIRS technology designed for assessing wound perfusion and~     oxygenation, this study seeks to adequately identify viable from non-viable wounds and to~     rapidly determine indication for vascular interventions. This technology is well-suited for~     use in a wound patient population as the measurements times are short and can quickly be used~     at the patient bed side. As such, this project intends to apply NIR technology to quickly~     assess PVD in the investigators' patient population.~   "
71988|NCT02624661|"~     Trigeminal neuralgia is one of the strongest pains known to humans. Some patients do not have~     enough effect with the available pharmaceutical treatments and are offered a type of surgery,~     which involves the injection of glycerol in a nerve structure called trigeminal ganglion. The~     researchers will do a pilot study on 10 patients with a new surgical technique using~     neuronavigation. The researchers believe that this new neuronavigation-based system can~     improve the precision of the technique and reduce the risk for complications.~   "
74266|NCT02594787|"~     The aim of the trial is to investigate the effect of ingestion of 75g of glucose (with or~     without phosphorus) on diet induced thermogenesis (using indirect calorimetry) and appetite~     (using visual analogue scales) in lean and obese healthy subjects~   "
71991|NCT02624622|"~     Studies in several countries with a high rate of death of infants during the first week of~     life have found a reduction in infection and mortality when chlorhexidine is applied to the~     umbilical cord stump by a health worker within 24 hours of birth. This study will evaluate if~     providing chlorhexidine to pregnant women during a prenatal care visit for application to the~     cord stump after birth will be as effective for preventing omphalitis (infection of the~     umbilical cord stump) as sending a community health worker into the home to apply the~     chlorhexidine.~   "
71992|NCT02624609|"~     Consumption of carbohydrate containing foods or sugary drinks brings about changes to the~     blood glucose levels. After a meal or drink, blood glucose rises until it reaches a peak~     concentration usually after 30 minutes. When the body senses the increase in blood glucose, a~     hormonal process involving insulin takes place to ensure that the glucose is taken up from~     the blood for storage and where it is needed for energy in the body. This process then brings~     about a decrease in the concentration of glucose until it reaches approximately the starting~     concentration. The original concentration of glucose is attained approximately 2 hours after~     eating or drinking a carbohydrate food or sugary drink respectively in healthy people.~      Different carbohydrates and sugary drinks have different effects on blood glucose response~     depending on the amount as well as the type of carbohydrate. Those that give rise to a high~     glucose response compared to a reference carbohydrate (usually glucose) are said to be high~     glycaemic index (GI) foods and those with a lower glucose response compared to a reference~     carbohydrate (usually glucose) are said to be low glycaemic index (GI) foods.~      Research has shown that diets that give rise to a high glucose response are associated with a~     number of abnormalities like increased risk of metabolic syndrome. Metabolic syndrome mostly~     comprises of insulin resistance and glucose intolerance which gives an increased risk of type~     2 diabetes. It also gives rise to other conditions like high blood pressure (arterial~     hypertension), elevated blood insulin levels (hyper-insulinemia), elevated amounts of fat in~     the liver (fatty hepatosis) and elevated amounts of lipids in the blood (dyslipidemia). After~     type 2 diabetes become clinically apparent, the risk of cardiovascular disease also rises.~     Research has also shown that foods/drinks which raise blood glucose levels gradually (low GI)~     rather than rapidly (high GI) have health benefits which include reducing the risk of~     metabolic syndrome. Laboratory studies have shown that polyphenols found in fruits,~     vegetables and plant based foods have a positive effect on carbohydrate metabolism and can~     lower the blood glucose levels.~      This research will determine whether the presence of polyphenols in the diet has any lowering~     effect on the blood glucose levels and hence the glycaemic index of foods. This will be~     determined by asking volunteers to consume commercially available food supplements together~     with white bread and then determining the glycaemic response. The blood glucose response of~     bread will be determined initially as a control reference. All will be consumed in random~     order.~      Analysis will be done by measuring blood glucose response after consumption of the control~     reference meal and the test meal containing polyphenols and then determining the incremental~     area under the glucose curve.~   "
71993|NCT02624596|"~     The purpose of this study is to understand how ketamine brings about rapid improvement in~     Obsessive-Compulsive Disorder (OCD) symptoms.~   "
71994|NCT02624583|"~     Ramadan fasting (RF) has been shown to be associated with vascular and metabolic disorders~     including glycemic control and lipid profile. It may also alter pharmacologic properties of~     some medications. Many patients with CAD and under Clopidogrel insist to observe the fasting~     and taking the risk of altering the pharmacologic proprieties of this drug.~      The aim of this study is to assess the effects of RF on clopidogrel resistance in patients at~     high cardiovascular risk with particular interest to patients with DM.~   "
71995|NCT02624570|"~     The purpose of this study is to provide access to Midostaurin and gather additional safety~     data on the combination of Midostaurin and standard of care for adult patients with newly~     diagnosed Fms-like tyrosine kinase receptor (FLT3) mutated Acute Myeloid Leukemia (AML) who~     are eligible for standard induction and consolidation chemotherapy.~   "
71996|NCT02624557|"~     To characterize the pharmacokinetics and safety of alpelisib in subjects with hepatic~     impairment compared to matched healthy control subjects.~   "
71997|NCT02624544|"~     Proton pump inhibitors act in blocking acid secretion and also have antioxidant and~     anti-inflammatory properties. For that mechanisms possibly PPIs may have an anti-inflammatory~     action with improvement in skin lesions in patients with psoriasis.~   "
71998|NCT02624531|"~     Patients with cervical cancer staging IB1-IIA2 desiring keeping their fertility function will~     be recruited. Before treatment, MRI scanning will be used to exclude retroperitoneal lymph~     node metastasis, involvement of lower part of uterus and endometrial carcinoma.If there is no~     macroscopic tumor and no obvious disease in MRI,simple trachelectomy (ST) + sentinel lymph~     node biopsy (SLNB) / retroperitoneal lymph node dissection(RPLND) will be performed.~     Otherwise,two to three cycles of neoadjuvant chemotherapy (NACT) will be administrated and~     then different fertility-sparing surgery(conization,ST or radical trachelectomy(RT) +~     SLNB/RPLND) will be employed depending on the tumor size.~   "
71999|NCT02624518|"~     This phase II/III trial studies how well gallium (Ga) 68-labeled gastrin-releasing peptide~     receptor (GRPR) antagonist BAY86-7548 (68Ga-RM2) positron emission tomography (PET)/magnetic~     resonance imaging (MRI) works in detecting prostate cancer in patients with negative computed~     tomography (CT) scan and elevated prostate-specific antigen levels after treatment with~     surgery or radiation. PET/MRI scans take both PET and MRI images at the same time and combine~     them into a single picture and is used to describe information regarding the function, as~     well as location and size of a tumor. 68Ga-RM2, a compound made of a radioactive agent linked~     to a pharmacological substance that is strongly attracted by a substance made by tumor cells,~     to detect prostate cancer. 68Ga-RM2 PET/MRI may be able to see smaller tumors than the~     standard of care contrast-enhanced CT or MRI scan~   "
72000|NCT02624505|"~     The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test~     product to the reference product, using bronchoprovocation (methacholine challenge testing)~     in adult patients with stable mild asthma.~   "
72001|NCT02624492|"~     Part 1 (Phase Ib)~      Primary objective:~      To establish the maximum tolerated dose (MTD) of BI 836826 in combination with GemOx.~      Secondary objectives:~      To evaluate pharmacokinetics of BI 836826 when given in combination with GemOx and to~     investigate preliminary efficacy in terms of the overall response rate based on~     investigator's assessment.~      Part 2 (Phase II randomized)~      Primary objective:~      To investigate the efficacy by means of the overall response rate (PR+ CR) based on central~     review assessment in patients with relapsed DLBCL treated with BI 836826-GemOx compared to~     R-GemOx.~      Secondary objective:~      To investigate the efficacy by means of the complete remission rate based on central review~     assessment in patients with relapsed DLBCL treated with BI 836826-GemOx compared to RGemOx.~   "
72002|NCT02624479|"~     Chronic treatment and prophylaxis of vessel and soft tissue calcification as well as of renal~     calculi could be a future indication for sodium thiosulfate (STS). Using an oral formulation~     might increase the compliance and treatment success compared to parenteral administration.~      Three gastro-resistant formulations of STS for oral administration were developed with~     different release characteristics: fast-release, medium-release and slow-release tablets. Aim~     of the enteric coating was to increase the oral bioavailability of STS. The bioavailability~     and tolerability of these formulations for oral administration in healthy volunteers will be~     compared in this clinical trial.~   "
72003|NCT02624466|"~     Children with chronic kidney disease (CKD) suffer from one of the most devastating diseases~     in childhood resulting in a lifelong need for health care, and a 3 times decreased life~     expectancy. In addition, they have important comorbidities that negatively impact on their~     quality of life and integration in society, jeopardizing their future even after a potential~     transplantation. Retention of uraemic toxins is accepted to play a major role in the~     pathogenesis of the comorbid conditions, but studies in children are lacking. Furthermore,~     there are currently no good tools to evaluate severity and monitor adequacy of treatment,~     resulting in suboptimal management.~      The overall scientific objective of this four years UToPaed IWT-TBM project is to provide the~     clinician with new diagnostic and therapeutic tools for the management of children with CKD,~     based on the improved understanding of uraemic toxicity.~      In this first part of UToPaed, the investigators will associate concentrations of a wide~     variety of uraemic toxins with different comorbidities in CKD children, i.e. growth,~     protein-energy wasting, quality of life, cardiovascular risk factors, circadian rhythm, sleep~     quality, and psychosocial and neurocognitive functioning (i.e. cross-sectional and~     longitudinal). The toxins of which concentrations are best correlated with comorbidities~     during the progress of CKD and eventually have representative kinetics (UToPaed - part 2:~     Kinetic analysis) will be selected as markers. These markers will be, together with the~     comorbidities, further tracked after interventions, i.e. starting on dialysis,~     transplantation, changes in dialysis strategy (UToPaed - part 3 - intervention study).~      From the validated kinetic models (UToPaed - part 2 and 3), an open access user-friendly~     prediction simulator (PAEDSIM) based on patient characteristics and marker concentrations~     will be developed to optimise and individualise the dialysis therapy.~      By providing clinicians with more advanced and appropriate tools to improve management of all~     children with CKD, i.e. better assessment of the degree of renal dysfunction, better~     determination of the ideal time to start renal replacement therapy, and more accurate~     monitoring of dialysis adequacy, the investigators aim to improve neurocognitive and~     psychosocial functioning (short term), growth, maturation into puberty, and social~     integration (median term) and survival (long term).~   "
72004|NCT02624453|"~     The aim of the study is to evaluate systematic pre-antiretroviral cryptococcal antigen~     screening and pre-emptive fluconazole therapy in antigen positive patients, as a strategy to~     reduce morbidity and mortality due to AIDS associated cryptococcal meningitis in patients~     starting antiretroviral therapy at <100 CD4 in Cameroon.~   "
72005|NCT02624440|"~     This study evaluates the effect of prophylactic antibiotics in multiple myeloma. One third of~     patients will received treatment with clarithromycin, one third of patients will receive~     treatment with sulfamethoxazole/trimethoprim and one third will be observed without~     prophylactic antibiotics. All patients receive concurrent anti-myeloma treatment.~   "
72006|NCT02624427|"~     The study is investigating Intra ocular pressure (IOP) by Goldmann Applanation Tonometry,~     Dynamic Contour Tonometry, and the Corvis ST tonometer.~   "
72007|NCT02624414|"~     Aims:~        -  To study the feasibility of capsule colonoscopy in patients with Crohn's Disease (CD).~        -  To compare the results of capsule colonoscopy with conventional colonoscopy in assessing~          mucosal healing.~        -  To correlate the level of faecal calprotectin with the results of capsule colonoscopy~          and conventional colonoscopy.~        -  To document changes in clinical practice attributable to the capsule colonoscopy~          findings a) concordant with and b) in addition to the parallel findings at colonoscopy~          and ileoscopy.~      Project design: Cross sectional, prospective, comparative study~      Methodology: Patients of the Royal Melbourne Hospital (RMH) and other associated speciality~     clinics with an established diagnosis of CD who need assessment of mucosal healing and have~     consented to be part of the study will undergo capsule colonoscopy and conventional~     colonoscopy on the same day after undergoing bowel preparation. The images of both the~     conventional and capsule colonoscopies will be recorded. In addition calprotectin (an~     inflammatory marker in faeces) will be measured in a sample of faeces collected by the~     patients prior to the colonoscopy day.~      Professor Macrae and the scholarly selective student researcher will assess the recorded~     images obtained from capsule colonoscopies once the images have been deidentified.~      To assess the level of mucosal disease they will use the Simple Endoscopic Score for CD~     (SESCD).~      The results of the assessment of mucosal healing obtained from conventional colonoscopy will~     be compared with those of capsule colonoscopy and levels of faecal calprotectin will then be~     correlated.~   "
72008|NCT02624401|"~     Positron Emission Tomography (PET), Magnetic Resonance Imaging (MRI) and~     electroencephalography (EEG) studies will be carried out to reveal the neural correlates of~     consciousness. Consciousness of the subjects will be manipulated with anesthetic agents~     dexmedetomidine, propofol, S-ketamine and sevoflurane. One-hundred-and-sixty (160) healthy~     male subjects will be recruited to receive EC50 concentration of the anesthetic (40~     dexmedetomidine, 40 propofol, 20 S-ketamine, 40 sevoflurane) or placebo (20) while being~     imaged for cerebral metabolic rate of glucose (CMRglu). Also genetic, immunological and~     metabolomics samples will be taken and analysed to find possible genetic factors explaining~     the variability in drug response and to find chemical fingerprints of acute drug effect.~   "
72009|NCT02624388|"~     Toxicities related to pediatric cancer treatment can lead to significant illness, organ~     damage, treatment delays, increased health care cost, and decrease in quality of life. Such~     toxicities are largely due to tissue damage sustained by chemotherapy, and strategies~     designed to limit such cellular damage to normal tissues may reduce therapy-related morbidity~     and mortality. In addition to their in vitro and in vivo anti-cancer effects, naturally~     occurring soy isoflavones have anti-inflammatory and anti-oxidant properties, and have been~     shown to reduce side effects of therapy in adult oncology clinical trials. This study will~     examine the effect of genistein, the major isoflavone component in soybeans and the most~     extensively studied of the soy isoflavones, on short-term side effects of myelosuppressive~     chemotherapy in pediatric cancer patients. Subjects will be randomized to receive either: a)~     30 mg genistein daily throughout chemotherapy Cycles 1 and 2 and placebo during chemotherapy~     Cycles 3 and 4; or b) placebo daily during chemotherapy Cycles 1 and 2 and 30 mg genistein~     daily during chemotherapy Cycles 3 and 4. Investigators hypothesize that subjects will have~     fewer short-term therapy-related side effects during cycles of chemotherapy given in~     conjunction with genistein supplementation than cycles given with placebo.~   "
72010|NCT02624375|"~     The purpose of this study is to learn more about the immune response to varicella zoster~     virus (VZV).~   "
72011|NCT02624362|"~     An extended replication of Jaen & Dalton (2014), the investigators aim to investigate the~     role of odors and associated trigger beliefs on symptom perception and airway inflammation in~     individuals with asthma~   "
72019|NCT02624258|"~     Pilot open-label study to estimate the feasibility, safety and efficacy of intravenously~     administered, RNA electroporated autologous T cells expressing CD19 chimeric antigen~     receptors expressing tandem TCRζ and 4-1BB (TCRζ /4-1BB) costimulatory domains (referred to~     as RNA CART19) in Hodgkin Lymphoma (HL) patients. Subjects will be treated with IV~     administration of RNA anti-CD19 CAR T cells for a total of six doses over 3 weeks.~   "
72012|NCT02624349|"~     The human papilloma virus (HPV) is known to be an important cause of cervical and anal~     cancers. Studies on patients who have received a solid organ transplant (such as a liver or~     kidney transplant) have suggested the risk of HPV-related cancers may be higher in this~     population. The HPV vaccine, Gardasil®, has been approved for use in males and females by~     Health Canada. In studies on healthy subjects this vaccine is nearly 100% effective at~     preventing infections from HPV serotypes that are in the vaccine. These serotypes,~     representing different viral strains, are known to cause 70% of cervical cancers and 90% of~     genital warts. The vaccine was also shown to be very safe and well tolerated in healthy~     subjects. Transplant patients are at higher risk of HPV related complications and cancers. As~     a result transplant experts have recommended this vaccine for use in their patients; however~     there have been no studies looking at the response to vaccination or safety of this vaccine~     in solid organ transplant recipients. Our objective is to study the immune response and side~     effects of Gardasil® in children who have received kidney or liver transplants. We will study~     this by comparing immune responses to the vaccine in healthy adolescent females compared to~     female liver and kidney transplant recipients. We will be recruiting females ages 12-19, as~     the province of Ontario funds the vaccine for this group. We will evaluate the transplant~     subjects for side effects after they receive the vaccine. Our hypothesis is that transplant~     recipients will have lower immunogenicity than healthy controls.~   "
72013|NCT02624336|"~     Accumulation of dental plaque may result in negative effects on the tooth and tooth~     supporting periodontal tissue. In addition, it contributes to the development of caries and~     periodontal diseases. Therefore, an effective dental plaque control is essential for~     maintaining good oral hygiene. Mechanical plaque control has its limitation thus chemical~     plaque control may be used as an adjunct in dental plaque control. Various types of medicinal~     plants can be utilized as stable, safe and biologically active plant-derived galenicals as~     alternative to synthetic mouth wash. Among these plants, Salvadora persica L. (Sp) root~     sticks and green tea (Gt) aqueous extracts were reported to have anti-microbial activity~     against many oral bacteria. The objective of this study was to investigate the efficacy of~     the combination of Gt aqueous extract and Sp aqueous extract as a synergistic anti-bacterial~     and anti-adherence efficacy against primary plaque colonizers.~   "
72014|NCT02624323|"~     The main intention of this study is to compare two ultrasound-guided central venous~     catheterization procedures namely: real-time, ultrasound-guided, in plane axillary vein~     catheterization and real-time, ultrasound-guided, out of plane jugular vein catheterization~     in terms of venipuncture, catheterization success, early mechanical complication and~     catheter-related infection rate in mechanically ventilated patients admitted to the intensive~     care unit.~   "
72015|NCT02624310|"~     The aim of this study is to increase norepinephrine levels in a population of young adults~     where NE levels are very low or undetectable. In order to achieve this, the optimal dose will~     be determined in a titration step. In the titration step, different doses of L-DOPS will be~     tested in order to find the optimal and safest dose suitable for each individual enrolled in~     the study. Because L-DOPS has never been used in the US in children or young adults, with~     this titration step investigators will also determine the safest dose for this population.~      Currently, L-DOPS is being used in our center to treat othostatic hypotension in autonomic~     failure. The titration step for this study starts with the dose of 100 mg and increases in an~     escalating manner up to a maximum of 600 mg a day (see investigational brochure attached).~      L-DOPS has been developed in capsules for oral used and all the previous safety data has been~     performed using this route. Oral route is the one that will used during study.~      Carbidopa is well tolerated, safe in children and it has been used in this population in the~     US without severe adverse effects.~   "
72016|NCT02624297|"~     The investigators hypothesize that chemoreflex response of muscle sympathetic nerve activity~     (MSNA) during hypoxia and hypercapnia will be increased in coronary artery disease (CAD)~     patients and that the presence of obstructive sleep apnea (OSA) will potentiate these~     responses. And, that the exercise training would decrease the chemoreflex response of MSNA in~     these patients.~   "
72017|NCT02624284|"~     Behaviors such as tobacco use, unhealthy diet, and sedentary behavior have far-reaching~     health implications. These modifiable behaviors account for a substantial proportion of~     deaths from cancer, cardiovascular disease and diabetes, and take a significant economic~     toll. Yet, many unhealthy behaviors are very resistant to change, despite widespread~     knowledge of the risks. Although theories of behavior change have been advanced to explain~     the persistence of these behaviors, few consider the neurobehavioral underpinnings. These~     approaches also fail to address a fundamental aspect of behavior change - an individual's~     ability to exert sufficient self-control to overcome temptations for immediate gratification~     and/or to maintain attention to long-term goals. With advances in the neuroimaging field, the~     investigators are learning where and how self-control over decisions and behaviors is~     executed in the brain. This work points to the central role of neural activity in the~     dorsolateral prefrontal cortices (DLPFC) in self-control processes that contribute to healthy~     choices. Further, emerging evidence shows that activity in the prefrontal cortices and~     cognitive control circuits can be modulated using a noninvasive and safe intervention: direct~     current transcranial stimulation (tDCS). The investigators pilot study, IRB study #820231,~     demonstrated that a single session of 1mA tDCS increased the ability to resist smoking in a~     validated smoking lapse paradigm. The current study will use a between-subject design to~     investigate the dose/response relationship between tDCS (administered at 1mA, 2mA, or sham~     stimulation for three sessions) and ability to resist smoking.~   "
72018|NCT02624271|"~     Despite the declining incidence, gastric cancer (GC) remains the second leading cause of~     cancer death worldwide. In France, it is the second digestive cancer with 7,000 new cases per~     year. It is now well demonstrated that patients with H. pylori infection, atrophic gastritis~     and intestinal metaplasia, have a high risk of developing GC. It is therefore important to~     detect these pre-neoplastic lesions at an early stage to improve patients prognosis.~      Thus, the aim of this project is to investigate the possible screening of gastric~     precancerous lesions by a blood test (GastroPanel®) in France, in patients with~     oesophagogastroduodenoscopy (EGD) prescription.~   "
72020|NCT02624245|"~     Assess pain, performance function, hip and knee strength and kinematics of trunk and lower~     limbs during single leg hop test after movement control training associated to hip and knee~     muscle strengthening.~   "
72021|NCT02624232|"~     Background Anorectal malformations(ARM) are rare and cover congenital defective development~     of rectum.~      ARM include a range of congenital conditions and may in varying degrees involve the~     anorectum. A significant part have malformations in other organs mainly the urinary tract.~      In the vast majority ARM are recognized at birth by lack of a normal anus. The primary~     approach is construction of a stoma and subsequent reconstruction. Bowel continuity is~     typical restored after 4-6 months.~      Many patients experience abnormal bowel function later on and affected quality of life(QoL).~      Aim~      The primary objective is to assess the patient-related outcome 10-30 years after surgery for~     ARM and to see if it related to existing damage to anorectum and bowel function. The~     secondary objective is to identify problems with bowel function which may be treated~     medically or by surgery to improve bowel function and QoL. To obtain the necessary knowledge~     the study is divided in the following sub-projects:~        1. Assessment of bowel function and QoL through relevant questionnaires~        2. Examine sphincter anatomy and function through rectal ultrasound, magnetic~          resonans(MR)-scan of the pelvis and anal manometry. Bowel function is assessed through~          colonic transit time. Screening for urinary tract problems with uroflowmetry.~      Methods Participants are identified through relevant diagnostic codes(Q 42) and patients~     which underwent surgery for ARM in the years 1985-2005 are included if informed consent is~     obtained.~      Relevant questionnaires regarding symptoms and QoL are completed before the following~     examinations:~        -  Anal manometry~        -  Anal ultrasound~        -  Pudenda conduction velocity~        -  Colonic transit time~        -  Magnetic resonans(MR)-scan of lower abdomen and pelvis~        -  Uroflowmetry~      Bowel function and QoL is assessed in both children and adults with relevant validated~     questionnaires.~      Perspective No danish studies and only a few foreign investigate the relationship between~     anatomy/physiology and quality of life after surgery for anorectal malformations.~      The investigators believe the study and included comprehensive examinations will clarify the~     causes of functional problems after surgery for anorectal malformations. Results of~     questionnaires regarding symptoms, disease-specific-and general quality of life offer a~     unique opportunity for targeted treatment to improve symptoms and QoL in patients with ARM.~   "
72022|NCT02624219|"~     This is a Phase I randomized, double-blind, controlled trial in 275 males and non-pregnant~     females, 19 to 64 years old, inclusive, who are in good health and meet all eligibility~     criteria. This clinical trial is designed to assess the safety, reactogenicity, and~     immunogenicity of a monovalent inactivated influenza A/H5N8 virus vaccine manufactured by~     bioCSL administered at different dosages (7.5 or 15 mcg of HA/0.5 mL dose) given with or~     without AS03 or MF59 adjuvants manufactured by GlaxoSmithKline Biologicals and Novartis~     Vaccines and Diagnostics, respectively.~   "
72023|NCT02624206|"~     This is an etiology study designed to examine the how people's brains and behaviors respond~     to regularly consuming a beverage. Participants are assessed at 2 behavioral assessments~     (Wave 1 and Wave 2), 2 scans (at the BRIC), and at 9 'intervention' assessments (5-10mins)~     different time periods throughout the study. At their first assessment (W1) they are~     randomized into one of two juices.~   "
72024|NCT02624193|"~     Preliminary data from the investigators' National Center for Complementary and Alternative~     Medicine (NCCAM)-funded R21 on mindfulness-based stress reduction (MBSR) in HIV-infected~     youth suggest an association between mindfulness and improved self-regulation and medication~     adherence. This randomized, controlled trial will help the investigators to better understand~     the specific impact of MBSR on HIV medication and treatment adherence in HIV-infected youth,~     and the efficacy of MBSR in the amelioration of stress and improved self-regulation.~   "
72025|NCT02624180|"~     The investigators are studying whether an anti-inflammatory intervention improves impaired~     coronary endothelial function (CEF) in HIV+ people with no clinical coronary artery disease~     (CAD).~   "
72026|NCT02624167|"~     A 4-week Phase IIa study to evaluate the safety and tolerability and efficacy of NW-3509A in~     patients with chronic schizophrenia that are not responding adequately to their current~     antipsychotic medication (aripiprazole or risperidone). NW-3509A is given as an oral dose~     range of 15 to 25 mg, BID in a 1:1 ratio.~   "
72027|NCT02624154|"~     Investigator determined the factor of surgery associated with the survival of pancreatic~     neuroendocrine tumor.~   "
72028|NCT02624141|"~     This study will examine the efficacy, safety, and effect on hemoglobin levels, of once weekly~     epoetin beta subcutaneous injections (30,000 International Units [IU]) in anemic patients~     with solid tumors. The anticipated study duration is 4 months, and the target sample size is~     40 individuals.~   "
72029|NCT02624128|"~     V-CHANCE is a phase 2, trial exploring the feasibility and the activity of valproic acid~     (VPA) in combination with the standard cisplatin-cetuximab combination in patients with~     recurrent/metastatic squamous cell carcinoma of the head and neck, never treated with~     first-line chemotherapy. The study includes an explorative analysis of the potential~     prognostic or predictive role of several biomarkers with the aim of improving the knowledge~     of the mechanisms by which VPA enhances chemotherapy effect and of identifying early~     predictors of treatment response/resistance.~   "
72030|NCT02624115|"~     Colorectal cancer (CRC) is one of the leading causes of cancer mortality in Canada. Rectal~     cancers are now known to be hypoxic which is a negative prognostic factor and predictive of~     metastatic spread and poor responsiveness to treatment. This has also been shown in~     preclinical xenograft models. Hence there is a need for identification of hypoxic rectal~     cancers.~      In this pilot study the investigators intend to non-invasively assess the tumor and nodal~     metastasis using an integrated Positron Emission Tomography-Magnetic Resonance Imaging~     scanner (PET/MRI) with 18F-Fluoroazomycin Arabinoside (18F-FAZA) a radiopharmaceutical for~     assessing tumor hypoxia. The hypoxic rectal tumors will show an increased uptake of 18F-FAZA~     on PET which will have morphological correlation on MRI. The patient will then undergo~     neoadjuvant chemoradiation therapy (CRT) followed by repeat 18F-FAZA PET/MRI and rectal~     cancer surgery with pimonidazole staining. Pimonidazole is an extrinsic marker of hypoxia~     that is selectively reduced and covalently bound to intracellular macromolecules in areas of~     hypoxia within normal and tumor tissue with current approval for use in humans for research~     studies.~      The primary goal of this pilot trial is to validate FAZA-PET as a biomarker of hypoxia by~     correlating its uptake in rectal tumors to pimonidazole staining in histopathology specimens.~     If the investigators pilot study successfully demonstrates the uptake and correlation of~     pimonidazole and FAZA-PET, the investigators would like to initiate a larger study examining~     hypoxia in rectal cancer. The investigators aims would be to image patients with locally~     advanced rectal cancer before CRT to ascertain whether high FAZA-PET uptake correlates with~     poor outcome to CRT. The ability to preoperatively predict the patient sub-population that~     will respond best to CRT, will help to identify the complete pathological responders and~     avoid unnecessary surgery. Furthermore, the FAZA-PET high subset of patients may benefit from~     other treatment strategies including clinical trials of anti-hypoxic agents.~   "
72031|NCT02624102|"~     Major Depressive Disorder (MDD) is a mood disorder, highly prevalent in Brazil and in world.~     The treatments of choice are the psychotropic drugs of the class of antidepressants and~     Behavioral or Cognitive Behavior Therapy (CBT). The aim of this study is to compare the~     efficacy of Trial Based Cognitive Therapy with the Behavioral Activation and pharmacotherapy~     in the treatment of MDD in a randomized clinical trial witch 96 patients with MDD,~   "
72032|NCT02624089|"~     The objective of this study is to assess whether the administration of nebulized~     intra-peritoneal ropivacaine at the onset of surgery, compared with nebulized saline, reduces~     morphine consumption after laparoscopic appendectomy surgery in children and adolescents.~   "
72520|NCT02617719|"~     Comprehensive Geriatric Assessment is an effective process to identify and address the needs~     of older patients. In the United Kingdom this usually takes place in acute care or in the~     patients home. This project will assess the feasibility of implementing this service in~     primary care.~   "
72033|NCT02624076|"~     Infertility affects one in six couples. In a quarter of them, routine tests of semen quality,~     ovulation or tubal patency fail to reveal any abnormalities and the cause of infertility is~     unexplained. Acupuncture is being increasingly used by couples with all types of infertility~     and initial trials have suggested that it could be potentially beneficial in some cases. A~     number of systematic reviews of acupuncture in IVF have shown conflicting results, but there~     is no evidence to inform best practice in unexplained infertility. In addition, as an~     intervention, acupuncture is not cost neutral as it involves multiple visits for treatment~     sessions delivered by a skilled practitioner. Thus, while acupuncture could have the~     potential to increase live birth rates in women with unexplained infertility, the clinical~     and cost effectiveness of acupuncture needs to be confirmed in the context of a large~     randomized controlled trial.~   "
72034|NCT02624063|"~     The purpose of the study is to study the combination of Sofosbuvir in Combination With~     Daclatasvir or Simeprevir for 12 Weeks in Non-cirrhotic Subjects Infected With Chronic~     Hepatitis C Virus (HCV) Genotype 1.~   "
72035|NCT02624050|"~     Patient undergoing general anesthesia in elective surgery will be assigned to receive either~     methohexital or propofol general anesthesia. Hypotensive events during the first 15 minutes~     of induction will be compared between the groups to ascertain which drug is less likely to~     cause a hypotensive event.~   "
72036|NCT02624037|"~     The introduction of infliximab (IFX) and other monoclonal antibodies (MAbs) targeting tumor~     necrosis factor (TNF) was a major advancement in the management of inflammatory bowel disease~     (IBD). These biologics were able to improve the health outcomes of many IBD patients for whom~     other treatments were neither satisfactory nor sufficient. Despite clear advantages and~     increased use of these treatments, physicians still see a loss of response in up to 50% of~     their IBD patients within one year of initiating these therapies. Most of these phenomena are~     attributed to low drug concentrations in the presence or absence of anti-drug antibodies~     (ADA).~      The fundamental issue is that approved/on-label dosing of these drug therapies does not take~     into account the various factors that impact the way an individual's body responds and~     processes these therapies. Dashboard software systems can quickly integrate patient data and~     serve as a revolutionary decision-support tool for physicians. The Precision IFX dashboard~     prototype was specifically developed to facilitate dosing of therapeutic monoclonal~     antibodies by integrating patient's clinical characteristics and drug concentrations into~     pharmacokinetic (PK) algorithms. Using clinical observations and patient laboratories, the~     system provides multiple dosing regimens that could allow the patient to attain and sustain a~     therapeutic drug trough level.~      Using the Precision IFX dashboard to analyze and forecast optimal dosing regimens with~     prospectively collected individual patient data, the clinician will select an appropriate~     dose to actively maintain therapeutic drug trough levels throughout the infliximab~     maintenance period. This study aims to examine the outcomes of one year of maintenance~     infusions in IBD patients dosed using the Precision IFX dashboard prototype and compare the~     results with historical controls.~   "
72037|NCT02624024|"~     The AQT90 FLEX Troponin I (TnI) and Troponin T (TnT) Tests are in vitro diagnostic assays~     intended as an aid in the diagnosis of myocardial infarction (MI) in point-of-care and~     laboratory settings. The purpose of the study is to establish the clinical performance of the~     AQT90 FLEX TnI and TnT assays for both whole blood and plasma in the intended use population.~   "
72038|NCT02624011|"~     This study will investigate the influence of increased sedentary time on long-term measures~     of muscle protein synthesis and metabolic health. The investigators will test the hypothesis~     that increased time spent in sedentary behaviours will lead to a reduction in long-term~     measures of muscle protein synthesis and compromised metabolic health.~   "
72039|NCT02623998|"~     The purpose of the study is to determine whether in patients with early type 2 diabetes,a~     short-term intensive metabolic intervention comprising of sitagliptin, metformin, basal~     insulin glargine and lifestyle approaches will be superior to standard diabetes therapy in~     achieving sustained diabetes remission.~   "
72040|NCT02623985|"~     The purpose of this study is to evaluate accuracy of rapid tests for group A beta hemolytic~     streptococci in patients who presented with sore throat at out patient department in Siriraj~     Hospital.~   "
72041|NCT02623972|"~     This research study is studying a drug called eribulin combined with standard treatment as a~     possible preoperative treatment for HER2 negative inflammatory breast cancer.~   "
72042|NCT02623959|"~     The goal of this clinical research study is to compare indwelling pleural catheters (IPC) in~     combination with saline (the current standard of care) versus IPC in combination with~     doxycycline as treatment for pleural effusions.~   "
72043|NCT02623946|"~     Study Design:~      Phase 4, pilot, single center, observational study. MEP's will be obtained twice, two weeks~     apart at baseline and every 6 months for 36 months (total of 14 sessions of MEP's)~      MEP's will include:~        1. Onset latencies and CMCT to bilateral abductor pollicis brevis and tibialis anterior~          muscles~        2. MEP amplitudes and the ratio of the central to peripherally obtained motor amplitudes~          (MEP-M ratio) to bilateral abductor pollicis brevis and tibialis anterior muscles~          Clinical measures (EDSS, MEP's, T25FWT, 6MWT, 9HPT) will be obtained at baseline and~          every 6 months for 36 months.~      Study location: Single center in Canada~      Study Objectives:~      Primary: To evaluate the reliability of MEP's in Alemtuzumab treated MS patients over a 36~     month period.~      Secondary: To determine the degree of correlation between MEP's and presently used clinical~     measures of efficacy (EDSS, 6MWT, T25FWT, 9HPT) and to determine if MEP's can predict who~     will require a third cycle of Alemtuzumab.~   "
72044|NCT02623933|"~     Radiation therapy plays an important role in the management of prostate cancer. In recent~     years it has become evident that higher doses of radiation are required to optimize disease~     control. The limiting factor of escalating dose to the prostate is the surrounding normal~     tissue. Despite advances in escalating radiation therapy, failures still occur in 20-30% of~     patients most often at the site of the original primary disease. As such there is growing~     interest in further dose escalating to the area of primary disease burden.The aim of this~     work is to look at the feasibility and toxicities of an integrated focal boost to whole gland~     prostate treatment using high dose rate brachytherapy.~   "
72045|NCT02623920|"~     This phase II trial studies how well brentuximab vedotin, bendamustine, and rituximab work in~     treating patients with B-cell non-Hodgkin lymphoma that has returned after a period of~     improvement or has not responded to previous treatment. Monoclonal antibody-drug conjugates,~     such as brentuximab vedotin, use antibody to target chemotherapy in cancer cells. Drugs used~     in chemotherapy, such as bendamustine, work in different ways to kill cancer cells.~     Monoclonal antibodies, such as rituximab, kill the cancer cells directly, but also harness~     the immune system to kill the cancer cells. Adding brentuximab to rituximab may improve~     response rates in CD30 positive, CD20 positive Relapsed Refactory NHL.~   "
72521|NCT02617706|"~     EPIFLO® unit along with standard wound care vs only standard wound care for Surgical site~     infections (SSI).~   "
72046|NCT02623907|"~     With the aging of Chinese population, degenerative valvular disease is becoming more and more~     frequent, which has brought a heavy burden to our society. Taking aortic stenosis (AS) as an~     example, the incidence of AS in population over the age of 65 are about 2%, and in population~     above the age of 85 can be amounted to 4-8%, in the Western country. Since the invention of~     transcatheter aortic valve replacement (TAVR),aortic valve disease (AVD),including AS and~     aortic regurgitation (AR), has attracted more and more attention. To date, there are few data~     about the prevalence of AVD in China. The characteristics and prognosis of AVD in China are~     still unknown. Therefore, the investigators design a prospective, observational cohort study~     to investigate characteristics, treatments and prognosis of AVD in Chinese elderly~     population. The results of the study will provide a basis for the future national health~     policy for prevention and treatment of AVD in the elderly.~   "
72047|NCT02623894|"~     Introduction: The process of population aging that is occurring in developed societies~     represents a major challenge for the health system. The aim of this study is to analyze~     factors that have an influence on early vascular aging (EVA), estimated by carotid-femoral~     pulse wave velocity (cf-PWV) and Cardio Ankle Vascular Index (CAVI), and to determine~     differences by gender in a Spanish population.~      Methods and analysis: An observational, descriptive, cross sectional study.~      Study Population: From the population assigned to the participating Health Care centers, a~     cluster random sampling stratified by age and gender will be performed to obtain 500~     participants aged between 35 and 75. Those who meet the inclusion criteria and give written~     informed consent will be included in the study.~      Measurements: Main dependent variables: cf-PWV determined using Sphigmo Cor System and CAVI~     estimated using VASERA. Secondary dependent variables: telomere length, carotid intima-media~     thickness, central and peripheral augmentation index, ankle-brachial pulse wave velocity,~     ankle-brachial index, retinal arteriovenous index, and renal and cardiac organ damage.~     Independent variables: Lifestyles (physical activity, adherence to mediterranean diet,~     alcohol and tobacco consumption); psychological factors (depression, anxiety, and chronic~     stress); inflammatory factors and oxidative stress.~      Ethics and dissemination: The study has been approved by the clinical research ethics~     committee of the healthcare area of Salamanca. All study participants will sign an informed~     consent to agree to participate in the study in compliance with the Declaration of Helsinki~     and the WHO standards for observational studies. The results of this study will allow the~     understanding of the relationship of the different influencing factors and their relative~     weight in the development of EVA. At least five publications in first-quartile scientific~     journals are planned.~   "
72048|NCT02623881|"~     To compare the effectiveness of cervical pessary (Arabin) and vaginal progesterone for~     preventing premature birth in twin pregnancies after IVF~   "
72049|NCT02623868|"~     Study to assess the pharmacokinetic/pharmacodynamic characteristics and safety/tolerability~     to CKD-519 new formulation in healthy male subjects.~   "
72050|NCT02623855|"~     The SHINE study is a randomized controlled study of the effect of a park-based family support~     group on multiple outcomes (including stress and physical activity) in a low income~     population.~   "
72051|NCT02623842|"~     Pilot study, case series conducted in women with a clinical diagnosis of urinary incontinence~     and were treated with radiofrequency technique for capacitive transfer non ablative in~     external urethral meatus. All participants did an hour Pad Test. The participants made five~     sessions of Radio Frequency (RF) with an interval of seven days between them. The application~     of RF was performed by physical therapist trained in the technique of radio frequency through~     the Tonederm® brand device with capacitive transfer method using non-ablative handle with~     electrode in the region of the external urethral meatro and coupling electrode placed on the~     participant's back. For application, the participants were in gynecological position. The~     session had an average duration of 20 minutes. The temperature was measured by an infrared~     thermometer when it reached 41graus radiofrequency was maintained for 2 minutes.~   "
72052|NCT02623829|"~     Dermatological surgeons wear many hats to care for subjects with skin cancer. While their~     role in cancerous tissue removal results in superior cure rates, there is also a need for~     skilled excisional repair and effective wound healing regimens so the subject can heal with~     the least amount of scarring necessary. As such, numerous techniques have been developed for~     reducing the morbidity associated with excessive scarring. Various flaps and grafts allow the~     surgeon to approximate skin texture, thickness and adnexa with respect to the residual~     surrounding tissue. However, for optimal cosmetic and functional outcome, specific suture~     techniques are often necessary to ensure close wound approximation while simultaneously~     minimizing static tension along the wound edge. In addition, there are post-operative~     techniques for wound care that range from special dressings during the various stages of~     healing to cosmetic procedures for scar modification. Unfortunately, once the operation is~     complete, there is little the surgeon can do to minimize adverse scar formation without~     impairing the healing process. To date, most surgical wounds are allowed to heal at least~     partially before scar revision or modulation is attempted.~      Botulinum toxin presents a unique opportunity for surgeons to affect scar formation~     throughout the duration of the healing process. These effects are likely independent and~     adjunctive to any and all wound care techniques, and are primarily attributed to a reduction~     in dynamic tension on the wound edges. Most importantly, botulinum toxin's one time dosing~     requirements with respect to reduced scar formation precludes the variance inherent to~     standard wound care practices.~      Therefore, it has been proposed that for selected subjects, botulinum toxin may be a safe,~     effective and reliable means for improved post-excisional repair outcomes. Botulinum toxin~     has been investigated as an inhibitor of excessive, post-excisional scar formation in plastic~     surgery and Otorhinolaryngology literature. However, these promising studies have yet to~     combine objective assessment measures of human scar formation in a randomized controlled~     trial. In addition, there are currently no formal studies of botulinum toxin as a~     prophylactic against excess scarring in the dermatological literature. Fortunately, Botulinum~     toxin dosing in the forehead for the purposes of inhibiting excessive scar formation is~     comparable to the amount given for cosmetic purposes, which is commonplace in dermatology and~     well-studied.~   "
72053|NCT02623816|"~     The overall aim of this study is to assess if patients with persistent GERD symptoms~     receiving sub-optimal omeprazole dosing experience improvement in GERD symptoms when~     prescribed an optimal dosing regimen. The optimal dosing regimen is defined as taking~     omeprazole 30 minutes prior to the first meal of the day.~   "
72054|NCT02623803|"~     The purpose of this study is to evaluate if a lidocaine infusion will provide benefit to~     pancreatectomy patients in regards to analgesia and return of bowel function.~   "
72055|NCT02623790|"~     Dairy products consumption is widely recommended in a healthy diet not only for bone growth~     and maintenance, but also as a protein, calcium and magnesium sources for an adequate diet.~     However, dairy products are a major dietary source of saturated fat that is associated with~     increased risk of coronary heart disease. ln this context, dietary guidelines still advocate~     a restriction in dietary saturated fat for optimal heart health. Nevertheless, the~     association between saturated fat and the risk of heart disease remains highly controversial~     within the scientific community. There is also emerging evidence that the impact of dietary~     saturated fat will be significantly influenced by the food matrix through which it is~     provided. Recent studies indicate that cheese could have a major influence on intestinal fat~     absorption and the magnitude of the after meal release of fat in blood circulation. This is~     of interest because substantial evidence exists indicating that elevated levels of the after~     meal fat levels are associated with increased cardiovascular risk. Therefore, the improvement~     of the after meal fat levels produced by cheese consumption could well be part of novel~     therapeutic approaches contributing to improve cardiovascular risk.~      The general objective of the proposed research is to investigate how cheese consumption~     affects the after meal release of fat in blood circulation in healthy subjects. Our~     hypothesis is that, compared to butter, cheese consumption will have a beneficial impact on~     the after meal fat levels in healthy subjects. Favourable results from the proposed study~     will provide novel and much warranted evidence on the importance of considering changes in~     the after meal fat levels, not only bad cholesterol, as part of the on-going saturated~     fat-heart disease debate and that cheese should indeed be part of a healthy diet.~   "
72056|NCT02623777|"~     During this project the investigators will evaluate whether the effects of arabinoxylan~     oligosaccharides (AXOS) consumption on insulin resistance in participants with metabolic~     syndrome can be explained by the production of short-chain fatty acids (SCFA). Secondly, the~     investigators will evaluate whether changes in gut hormone production might explain the~     effect on insulin resistance.~   "
72057|NCT02623764|"~     Drug treatment with cholinesterase inhibitors is indicated for treatment of Alzheimer´s~     disease and in most cases, one of these drugs is prescribed as soon as the diagnosis has been~     made. Nevertheless, it has been shown in several studies that up to 30% of patients do not~     benefit from treatment. These drugs can have side effects, most frequently from the~     gastrointestinal tract with nausea, diarrhea and discomfort in the abdomen as the most~     frequent signs. It is therefore important to know before the treatment is initiated if the~     patient will likely benefit from the drug or not. It is not possible today with current~     knowledge but this project aims to evaluate a specific index, calculated from an EEG~     registration (the EEG-cholinergic index) for this purpose. A conventional EEG registration is~     done before treatment and the cholinergic index calculated from the EEG registration is~     compared to the clinical outcome. The duration of follow up is 6 months with an extension of~     further 6 months.~   "
72058|NCT02623751|"~     The primary objective of the open-label, dose-escalation study is to investigate the safety~     of single-dose monotherapy and repeated-dose of KHK2375 combined with exemestane in female~     subjects with advanced or recurrent breast cancer. The secondary objective is to investigate~     the pharmacokinetics and efficacy.~   "
72059|NCT02623738|"~     The purposes of this study are to determine the optimal concentration of DE-117 ophthalmic~     solution compared to the placebo ophthalmic solution and to determine if intraocular pressure~     reduction after 4 weeks of treatment with DE-117 ophthalmic solution is non-inferior to~     latanoprost ophthalmic solution 0.005%.~   "
72060|NCT02623725|"~     The aim of the study is to assess and describe the booster effect of a CYD dengue vaccine~     dose administered 4 to 5 years after the completion of a 3-dose vaccination schedule.~      Primary Objective~      - To demonstrate the non-inferiority, in terms of geometric mean of titer ratios (GMTRs), of~     a CYD dengue vaccine booster compared to the third CYD dengue vaccine injection in subjects~     from previous CYD dengue vaccine trials.~      Secondary Objectives:~        -  If the primary objective of non-inferiority is achieved: To demonstrate the superiority,~          in terms of GMTRs, of a CYD dengue vaccine booster compared to the third CYD dengue~          vaccine injection in subjects from previous CYD dengue vaccine trials.~        -  To describe the immune responses elicited by a CYD dengue vaccine booster and placebo~          injection in subjects who received 3 doses of the CYD dengue vaccine in previous CYD~          dengue vaccine trials.~        -  To describe the neutralizing Ab levels of each dengue serotype post-dose 3 (previous CYD~          dengue vaccine trials' subjects) and immediately prior to booster or placebo injection~          in all subjects.~        -  To describe the neutralizing Ab persistence 6 months, 1 year, and 2 years post booster~          or placebo injection in all subjects.~        -  To evaluate the safety of booster vaccination with the CYD dengue vaccine in all~          subjects.~   "
72061|NCT02623712|"~     This study will compare two clinically accepted protocols for surveillance imaging in~     individuals who are found to have a small pulmonary nodule on chest computed tomography (CT)~     scans.~   "
72062|NCT02623699|"~     The primary objective of the study is to evaluate the safety, tolerability, and~     pharmacokinetics (PK) of BIIB067 in adults with ALS. The secondary objective is to evaluate~     the effects of BIIB067 on levels of superoxide dismutase 1 (SOD1) protein in the~     cerebrospinal fluid (CSF).~   "
72063|NCT02623686|"~     It is known from the literature that patients in the Intensive Care Unit do not get enough~     sleep impacting on short and longterm recovery (Tembo & Parker, 2009; Bihari et al, 2012;~     Kamdar et al, 2012). The use of non-pharmacological interventions such as massage with~     essential oils is supported by the literature as being useful in encouraging sleep (Richards~     et al, 2003; Matthews, 2011). Over 30% of cancer patients are accessing complementary~     therapies such as these (Rees et al, 2000; Lewith et al, 2002). We propose investigating~     whether aromatherapy massage and the use of essential oils in the form of an Inhalation Patch~     (Bioesse TM) prove to be a useful intervention for improving patient sleep whilst on the~     critical care unit.~   "
72064|NCT02623673|"~     Retrospective cases series is a non-randomized, open-label, single-center investigation~     (Retina Clinic, São Paulo, Brazil) of patients diagnosed with macular edema secondary to~     diabetic retinopathy (DME) and retinal vein occlusions who underwent to simultaneous~     treatment with intravitreal injection of bevacizumab 1.25mg and implant of dexamethasone~     0.7mg.~   "
72065|NCT02623660|"~     The purpose of this study is to determine if patients undergoing a total knee arthroplasty~     (TKA) experience a clinically significant reduction in healing time when treated post~     operatively with a specific form of micro and nano-ampere current. The results of this trial~     will provide a basis for generalizing its outcomes to apply to other joint replacements and~     revisions by reducing edema and inflammation and therefore will result in a shorter time to~     heal.~      The study will compare electrically treated and non electrically treated patients by using~     digitally based measurements to determine objective reductions of lower extremity edema~     including intra and inter cellular shifts in fluid distribution, increased range of motion~     (ROM) and muscle strength, and improved functional tests of ambulation.~   "
72066|NCT02623647|"~     The present is a phase I-II study testing the safety and the efficacy of extremely~     hypofractionated radiotherapy for early stage prostate cancer. The study is designed to~     assess GU toxicity while controlling tumor control, in terms of survival free from~     biochemical failure. 40 Gy in fxs will be delivered to patients with low and favourable~     intermediate risk prostate tumors.~   "
72067|NCT02623634|"~     the purpose of this study is to analyzes the factors influencing the results of cuff leak~     test, in order to improve the cuff leak test on the accuracy of the prediction on airway~     edema after extubation.~   "
72077|NCT02623504|"~     A phase 4 unequal randomization, double blind study to evaluate the dose tolerance and safety~     of extended release Equetro (carbamazepine) versus placebo followed by an Open label and long~     term maintenance treatment in children and adolescents aged 10-17 years diagnosed with acute~     manic or mixed Bipolar I Disorder~   "
72078|NCT02623491|"~     The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of~     JNJ-55375515 in healthy participants after administration of single and multiple oral doses.~   "
72068|NCT02623621|"~     A growing amount of reports has consistently evidenced that a sustained inhibition of the~     angiogenesis is an effective therapeutic strategy, able to improve the outcome of metastatic~     colorectal cancer (mCRC) patients.~      In the last decade different biologic agents targeting angiogenesis have been approved for~     the treatment of mCRC, such as bevacizumab, aflibercept and regorafenib, and, more recently,~     solid evidences have demonstrated the efficacy of a sustained antiangiogenic approach even~     beyond the first progression to a bevacizumab-containing regimen. In particular, two phase~     III randomized trials proved the effectiveness of prosecuting bevacizumab in second-line~     switching the chemotherapeutic regimen in patients already treated with bevacizumab in~     first-line. Preliminary experiences evidenced that circulating levels of angiogenesis-related~     markers are significantly modulated during first-line chemotherapy plus bevacizumab. In~     particular, a wide variability of plasma soluble Vascular Endothelial Growth Factor~     Receptor-2 (VEGFR-2) levels is observed at the time of disease progression and retrospective~     data suggest that benefit from the continuation of bevacizumab may be restricted to patients~     with high levels of soluble VEGFR-2 at the first evidence of disease progression. This study~     aims at prospectively validating those retrospective data.~   "
72069|NCT02623608|"~     After an energy-rich meal the blood levels of glucose and lipids undergo a marked temporary~     increase, triggering a wave of oxidative stress due to the appearance of excess free radicals~     in adipose and muscle tissues. Elevated postprandial hypertriglyceridemia has been associated~     with increased risk of cardiovascular disease and type 2 diabetes. Hence, postprandial~     changes in different circulating biomarkers are potential predictors of cardiometabolic risk.~     In addition to the possibility of evaluating acute variations in metabolic risk markers in~     response to different types of fat, the metabolic challenge approach may serve as a~     challenge-meal background in order to reveal possible beneficial effects of specific food~     ingredients. In this study, circulating cardiometabolic disease-related biomarkers, including~     endotoxemia, will be assessed postprandially in search for beneficial actions of particular~     functional food ingredients consumed in combination with a high-fat meal.~   "
72070|NCT02623595|"~     The purpose of this study is to determine whether stereotactic body radiotherapy (SBRT)~     combined with recombined human granulocyte-macrophage colony stimulating factor(rhGM-CSF) is~     safe, effective in the treatment of stage IV NSCLC patients who failed in second-line~     chemotherapy.~   "
72071|NCT02623582|"~     Pilot open-label study to estimate the feasibility, safety and efficacy of intravenously~     administered, RNA electroporated autologous T cells expressing anti-CD123 chimeric antigen~     receptors expressing tandem TCR and 4-1BB (TCR /4-1BB) costimulatory domains (referred to as~     RNA CART123) in Acute Myeloid Leukemia (AML) subjects.~   "
72072|NCT02623569|"~     Arms Assigned Interventions~      Experimental: Ivabradine Ivabradine 5 mg twice a day for first 4 weeks and 7.5mg twice a day~     when positive ETT and HR＞60times/min or negative ETT and HR＞80times/min of subjects.~      Active Comparator: Atenolol Atenolol 12.5 mg twice a day for first 4 weeks and 25mg twice a~     day when positive ETT and heard rate＞60times/min or negative ETT and HR ＞80times/min of~     subjects.~   "
72073|NCT02623556|"~     720 cases TB (Tuberculosis patients) participants、360 cases non-TB participants with lung~     disease and suspected TB patients who all meet the standard are divided into different groups~     through a randomized and blind method. Every subject inject intradermally ESAT6-CFP10 and~     TB-PPD (tuberculin purified protein derivative) in different arms of the same person by blind~     method. Specific gama-interferon (γ-IFN) detection is needed before the injection.Measure the~     induration and (or) redness of longitudinal diameter size and transverse diameter vernier~     caliper by vernier caliper after injection 24h, 48h and 72h. At the same time, we observe all~     kind of adverse events.~   "
72074|NCT02623543|"~     The high prevalence of myopia - especially in Asian countries - is well documented, as are~     the sight-threatening complications of high or degenerative myopia. Retinal detachment,~     glaucoma, vitreal degeneration and focal retinal changes occur secondary to the progressive~     axial elongation of the eye with age. Specialty rigid lenses have long been shown to lessen~     this progression in the pediatric population; orthokeratology (ortho-k) lenses are worn at~     night and change the corneal topography to correct low to moderate amounts of myopia. This~     same axial elongation has also been shown to occur in young adults with high near demands,~     however to our knowledge, there are no studies examining the effect of ortho-k lenses in this~     population. Our project seeks to investigate the efficacy of ortho-k in slowing axial~     elongation and myopic progression in subjects between the ages of 21-30. Results will help~     elucidate what role these specialty lenses may have in the management of the myopic patient~     throughout their development, as well as what potential they have in prevention of associated~     degenerative changes.~   "
72075|NCT02623530|"~     Considering the need for an intervention in the context of the Brazilian nursing education,~     in order to develop the skills and dispositions for critical thinking (CT), this study aims~     to fill this gap through a first aid course, comparing a group control and an experimental~     group. In this study will be used two tests, California Critical Thinking Dispositions~     Inventory (CCTID) to review arrangements for the CT, and California Critical Thinking Skills~     Test (CCTST) to evaluate CT skills, both marketed (Facione N, Facione PA, 2009 , 2011).~     Therefore, in order to facilitate the assimilation of PC skills during the course, we~     prepared the model of Active Teaching for Critical Thinking (MEAPC): characterized by a~     teaching method proposed by the author of this work, who understands the educational activity~     active and intentional as mobilizing higher mental processes fundamental to the development~     of the CT.~   "
72076|NCT02623517|"~     Patients with implantable heart devices including pacemakers, defibrillators, and cardiac~     monitors may not seek regular medical care related to their implanted devices. These devices~     are capable of detecting abnormal heart rhythms or other device abnormalities that may~     benefit from clinical action or oversight. A novel healthcare information technology has been~     developed and is being implemented clinically for screening of patients with cardiac rhythm~     devices who seek care in the emergency room setting. This study seeks to examine differences~     in detection of cardiac rhythm disturbances including atrial fibrillation (AF) with~     utilization of this new screening technology, and how often treatment plans change in~     patients who have a heart rhythm abnormality detected.~   "
72522|NCT02617693|"~     This study is conducted in Asia. The aim of this study is to assess the efficacy of a~     pre-pregnancy life style intervention to reduce the risk of diabetes and prediabetes.~   "
72079|NCT02623478|"~     This study evaluates a new test formulation of a glucose lowering drug, insulin lispro,~     delivered by an insulin pump continuously under the skin. The study will be conducted in~     participants with type 1 diabetes mellitus to investigate how the human body processes the~     new test formulation and its effect on blood sugar levels when it is delivered via an insulin~     pump. Side effects and tolerability will be documented. The study will last about 4 to 11~     weeks, including screening, lead-in and follow up. Screening is required within 28 days prior~     to entering the study.~   "
72080|NCT02623465|"~     The study will be conducted in participants with type 2 diabetes on insulin injection therapy~     to investigate how the body processes a test formulation of insulin lispro and the effect of~     the test formulation on blood sugar levels. Side effects and tolerability will be documented.~     The study will be conducted in two parts (Part A and Part B) to achieve its objectives.~     Participants are expected to enroll in both parts.~   "
72081|NCT02623452|"~     The study will be conducted in participants with type1 diabetes on insulin injection therapy~     to investigate how the body processes a test formulation of insulin lispro and the effect of~     the test formulation on blood sugar levels. Side effects and tolerability will be documented.~     The study will be conducted in two parts (Part A and Part B) to achieve its objectives.~     Participants are expected to enroll in both parts.~   "
72082|NCT02623439|"~     The primary objective is to determine overall survival 180 days after transplantation~     involving HLA-haploidentical stem cell/bone marrow graft, and post-transplant Cy.~   "
72083|NCT02623426|"~     The Macular Edema Ranibizumab v. Intravitreal anti-inflammatory Therapy (MERIT) Trial will~     compare the relative efficacy and safety of intravitreal methotrexate, intravitreal~     ranibizumab, and the intravitreal dexamethasone implant for the treatment of uveitic macular~     edema persisting or reoccurring after an intravitreal corticosteroid injection. MERIT is a~     parallel design (1:1:1), randomized comparative trial with an anniversary close-out at the 6~     month clinic visit. The primary outcome is percent change in central subfield thickness from~     the baseline OCT measurement to the 12 week visit.~   "
72084|NCT02623413|"~     The study aims to evaluate the impact of contact precautions on the rate of VRE- the rate of~     colonization and infection aand hospital-acquired VRE transmissions.~      Hematological and oncological wards in hospitals with a non-outbreak setting for VRE and~     adhering to at least the following standard of care are eligible for study participation:~      Fecal screening for the presence of VRE of all patients within 72 hours of each admission by~     use of a rectal swab or stool sample Follow-up fecal screening once a week and within 72~     hours of discharge Implementation of clinical standards aimed at VRE decolonization is not~     allowed on wards participating in this study, including in the context of clinical studies.~      Sites will be grouped according to their approach regarding contact isolation (see group~     description).~      As a control for external factors a hand hygiene program, including training and adherence~     assessments, will be implemented.~      This observational study prospectively compares wards with different approaches to isolation.~     All screening and isolation measures are already in place on participating wards (i.e.~     constituted a site selection criterion) and are exclusively implemented as part of the~     standard of care. Sites are free to adjust their standard of care as they see fit. No~     intervention will be performed.~   "
72085|NCT02623400|"~     In this project, the investigators will study a cohort of preterm infants, together with~     their parents, during NICU hospitalization and follow their developmental trajectory until~     the age of two.~      An important first scientific goal of the project is to identify objective stress markers~     that can be obtained easily and non-invasively in preterm infants during NICU~     hospitalization. This will include the development of novel techniques to measure stress~     related heart rate variability (HRV) and EEG maturation, as well as sleep stage markers for~     preterm infants.~      Secondly, the investigators will study the emotional and bonding processes in parents of~     preterm infants. Parental distress in terms of depressive symptoms, anxiety, perceived stress~     and parent-infant bonding will be measured at multiple measuring points. This will enable the~     validation of psychometric instruments in the specific population of parents of preterm~     infants. Also, the investigators can investigate the effect and predictive value of the~     course of parental depression, anxiety and stress scores on child's developmental outcome and~     on parent-infant bonding and attachment.~      Thirdly, studies on epigenetic changes due to prenatal stress are still scarce in humans. In~     this study, the investigators will include a cohort of mothers experiencing profound prenatal~     stress due to preterm labor, which will complement the earlier work that has been carried out~     in a low-risk population. The investigators expect more profound changes in methylation state~     of the NR3C1 and other promotor regions in their cohort of mothers exposed to important~     prenatal stress. Secondly, the methylation of oxytocin receptor regions will be studied in~     relation to attachment and bonding.~      An important overall goal of the project is to develop a Perinatal Stress Calculator that~     studies the value of the different neonatal, endocrinological, psychological and~     physiological stress-related parameters to predict differences in psychomotor, cognitive,~     behavioral, and emotional development. This longitudinal study design will enable the~     investigators to use the perinatal stress calculator to study the relation between the~     perinatal stress parameters and later developmental disabilities such as motor impairment,~     cognitive deficits, language delay but also social and behavioral problems such as~     attentional deficits and emotional self-regulation dysfunction.~   "
72086|NCT02623387|"~     The aim of this study is to compare conventional and ultrasound guided paravertebral blocks~     to with respect to efficacy, patient satisfaction and complication rates.~   "
72087|NCT02623374|"~     The study will be a randomised controlled trial (RCT) of a brief self-help CBT intervention~     (SHCBT), compared with a no treatment-wait control (NTWC) who do not receive the~     intervention, on the impact of hot flushes experienced by menopausal women in work settings.~     The study involves samples from a minimum of two large employers (who have already expressed~     an interest in taking part) and randomly allocating at least 50 eligible women to the SHCBT~     intervention and another 50 to a NTWC condition (i.e. a minimum of 100 participants in~     total). Both groups will complete baseline questionnaires (A0), and follow up assessments at~     6 weeks (A1) and 20 weeks (A2) post-randomisation. Questionnaires will be completed online or~     paper and pencil, providing data on the outcomes of interest to assess the interventions~     effectiveness and feasibility. Participants of the treatment group will also be invited to~     take part in an evaluation interview at A2. The NTWC will be offered the intervention~     off-trial.~   "
72088|NCT02623361|"~     Patients undergoing arthroscopic hip surgery have been shown to have significant~     post-operative pain that may delay discharge, recovery, and early mobilisation. A~     pre-operative regional anesthesia technique, the fascia iliaca block may be an effective~     method for acute post-operative analgesia.~      This is a prospective, randomized controlled study of the preoperative fascia iliaca block~     for patients undergoing hip arthroscopy.~      The enrolled patients will be randomized to receive either a fascia iliaca block with the~     local anesthetic ropivacaine or to have a sham block. All patients will receive a general~     anesthetic for the hip arthroscopy.~   "
72089|NCT02623348|"~     Randomized controlled trial using pedometers to increase physical activity among patients on~     dialysis.~   "
72090|NCT02623335|"~     The investigators will perform a multi-site cluster randomized trial that uses a~     stepped-wedged design to compare the effectiveness of a Question Prompt List (QPL)~     intervention to usual care for patients considering high-risk vascular (peripheral, cardiac,~     neuro) and oncologic operations. This 24-month study will use a time-dependent cluster~     randomization plan within each of the five study sites: the investigators will randomly~     assign time points for surgeons who perform high risk operations to cross over from usual~     care to QPL intervention. Study staff will audiotape the conversation between the patient and~     surgeon during one preoperative clinic visit; administer surveys to patients and family~     members at 24 hours, 6 weeks and 12 weeks after that visit; and record surgical decisions,~     treatments received and associated outcomes. The investigators will use stratified purposeful~     sampling to identify a subset of patients in each study arm who have experienced serious~     complications for qualitative interviews.~   "
72091|NCT02623322|"~     This is a Phase 2, randomized, double-blind, placebo-controlled single dose study in~     otherwise healthy adults with acute uncomplicated seasonal influenza A to assess the safety~     and tolerability, efficacy, and pharmacokinetics of MHAA4549A.~   "
72092|NCT02623309|"~     Allogeneic (Allo) hematopoietic stem cell transplantation (HSCT) is a recognized curative~     procedure for hematological malignancies. It is now well known that this property is related~     to the graft-versus-tumor (GVT) effect developed from the immunocompetent cells contained in~     or generating from the donor graft. For years, however, and despite this unique antitumoral~     activity, Allo-HSCT has been restricted to a limited number of patients due to two major~     limitations: the toxicity of the procedure and the absence of a donor for every single~     patients. More recently the stage has dramatically changed with respect to these two~     restraints. Over the last decade, many studies have established the feasibility of Allo-HSCT~     in older patients but the availability of MRD is even less frequent in elderlies, likely~     related to medical contraindication for graft donation or sibling deaths. UD are routinely~     used but associated with a high incidence of GVHD. As compared to younger populations,~     unrelated cord-blood HSCT is seldom performed in this population and numbers decrease with~     age due to the feared risk of supposed increased lethal infectious complications related to~     the effect of the delayed immune reconstitution in elderlies. Thus the need for alternative~     donors allowing for a safe and efficient transplantation is still unmet. In consequence,~     overall, despite the fact that Allo-HSCT feasibility has been established in the oldest~     patients, all these lacks contribute eventually to maintain a low rate of allo-HSCT performed~     in a population with the higher incidence of hematologic malignancies that usually present~     with the poorest prognosis.~      Thus it is critical developing innovative efficient therapeutic strategies answering this~     unmet-medical need. In this perspective, Haplo-HSCT could represent a part of the answer in~     this aged population. It offers the potential advantage to offer a rapid donor determination~     for virtually every single patient. In addition, our data suggest that in elderlies~     haplo-HSCT using T-repleted graft, RIC and PT-HDCy presents low NRM and retains an antitumor~     effect despite low GVHD incidences. They also suggest that haplo-HSCT may conduct to better~     outcome than URD-HSCT as an alternative to MRD-HSCT. It may also be associated with lower~     costs (no graft purchase and low post-transplant complications rate) and better QOL likely~     related to low cGVHD-rate. In addition the conduct of such trial at a time when the diffusion~     of the strategy in this population is just starting is really crucial before widespread~     uncontrolled dissemination.~      The investigators propose to address this question by prospectively comparing these 2~     strategies in elderly patients without MRD, in terms of efficacy, safety and including the~     prospective evaluation study of quality-of-life (QOL). They will conduct a national,~     multicenter, open-label, comparative, randomized phase III trial in patients with~     hematological malignancies justifying an allo-HSCT from an alternative donor when a MRD has~     not been identified.~      When MRD search is recognized to be a failure, patients will be included in the clinical~     trial after informed consent and randomized in the two strategies based on donor search:~        -  Reference group: Unrelated Donor group~        -  Investigational group: Haplo Donor Group~      Investigators will use a composite end-point embracing the three main causes of failure:~     death, relapse and severe cGVHD (as a surrogate endpoint for QOL). We will analyze the HSCT~     usual objectives as GHVD, NRM, relapse and survival. A specific study of patients' health~     related quality of life will also be conducted using the FACT-BMT questionnaire. In addition,~     the success of the two strategies in term of transplant completion (donor determination,~     transplant realization and time to do so) will be compared.~   "
72093|NCT02623296|"~     This will be a Phase I, randomized, double-blind, placebo-controlled, 2 period cross-over,~     drug-drug interaction study to evaluate the effect of multiple oral doses of GLPG1205 or~     placebo (daily from Day 1 to Day 12) on a single dose pharmacokinetic profile of a cocktail~     of CYP450 substrates administered to healthy male subjects. The cocktail of CYP450 substrates~     will consist of 10 mg warfarin (CYP2C9 substrate), 20 mg omeprazole (CYP2C19 substrate) and~     100 mg caffeine (CYP1A2 substrate).~      Fourteen healthy male subjects will receive during two treatment periods from Day 1 to Day 12~     a daily dose of GLPG1205 or placebo. On Day 13, a single dose of the cocktail of CYP450~     substrates will be co-administered either with GLPG1205 or with placebo. The two treatment~     periods will be separated by a wash-out period of at least 28 days.~      Also, the safety and tolerability of multiple oral doses of GLPG1205 administered with or~     without a cocktail of CYP450 substrates in healthy male subjects will be evaluated.~   "
72094|NCT02623283|"~     Historically dental health of Scottish children had been poor for many years. Evidence form~     clinical trials of fluoride toothpaste identified a route to improving prevention. Those who~     had poor dental health used fluoride toothpaste infrequently at home. The investigators~     hypothesised that this disadvantage could be overcome by supplying toothpaste to~     disadvantaged families and supervising child toothbrushing at school. In 1997, 534 children~     5.3 years were recruited in 12 primary schools in Tayside; randomly assigned to one of two~     groups - test group followed a home-to-school toothbrushing programme with fluoride~     toothpaste; control group: usual care. Children in test group were provided with toothbrushes~     and toothpaste (1,000ppmF as sodium monofluorophosphate) for home use; also brushed their~     teeth school daily. After 2 years, children participating in the supervised brushing~     programme developed significantly less caries (tooth decay).~      Permission was given for longitudinal follow up of children and dental records. The original~     intervention lasted 30 months and children were re-examined at 36 months after baseline, 48,~     60 and 84 months. At 84 month examination, 77% were available, found prolonged benefits of~     brushing programme. This was 4.5 years after the end of the programme; children were aged~     11.5 years. At age 14 years, 6.5 years after intervention end, 65% of children were~     reexamined; benefit was still evident at 20-26% less caries experience. However, there had~     been greater subject loss and insufficient funds available to undertake a more individual~     followup of participants.~      Since then, records have been followed; up-to-date contact details identified. Using this new~     data, the investigators seek to reconsent the participants, now aged 23 to invite them to~     attend a followup dental examination. This study has the potential to provide unique~     information on longterm costs and benefits of a home-to-school toothbrushing programme.~   "
72095|NCT02623270|"~     The purpose of this study is to determine whether an experienced anesthesia provider can~     adequately and/or easily mask ventilate an anesthetized patient with a commercial~     non-invasive ventilator device.~   "
72096|NCT02623257|"~     The study aims to explore the prevalence of EGFR mutations assessed with ctDNA samples in~     advanced NSCLC, who had received ≤ 1 prior systemic chemotherapy regimens.~   "
72097|NCT02623244|"~     To assess the relationship between ovarian endometrioma and lower urinary tract symptoms,~     sexual function and gastrointestinal symptoms. In addition, the investigators also assess the~     impact of surgeries for ovarian endometrioma on lower urinary tract symptoms, sexual function~     and gastrointestinal symptoms.~   "
72098|NCT02623231|"~     Testing the effect of providing an antidepressant and anxiety-type escitalopram for patients~     with glioblastoma on patient's quality of life including the effect of treatment on mood and~     cognition during treatment.Two subgroups will fill questionnaires :~        -  Questionnaire mini mental state exam (mmse) which is the maximum score of 30. A score of~          below 24 indicates a flaw in the level of dementia~        -  Questionnaire depression / mood PHQ9P(Pa t i e n t H e a l t h Qu e s t i o n n a i r e~          - 9)~        -  The M. D. Anderson Symptom Inventory (MDASI)~        -  Evaluation of the hospital situation awareness (clinical assessment and questionnaire)~        -  Cognitive assessment which will be carried out by the Department neuropsychological and~          include:~             -  Executive function (Stroop)~             -  Abstract Reasoning (similarities)~             -  -Auditory and Spatial Attention (Digit span, Spatial span) visual memory and~               remembering Literature~             -  Memory function - visual and auditory (ROCF, RAVLT)~             -  Language function: Naming and verbal fluency~             -  Mindstreems Neurotrax~   "
72099|NCT02623218|"~     The purpose of this study is to examine the effects of acupuncture on cerebral blood flow~     (CBF) and blood biomarkers during the acute 10-day window following traumatic brain injury,~     to determine if those changes correlate with changes in biomarkers of brain health,~     neuropsychological testing, and symptomatic presentation.~   "
72100|NCT02623205|"~     Despite current medications, morbidity and mortality of Major Depressive Disorder (MDD)~     remain high. According to the World Health Organization, MDD affects 121 million people~     worldwide, and is projected to be the second leading cause of global disability by 2020.~     Monotherapy with SSRIs is the most widely used treatment for MDD. However, on average, SSRIs~     require six weeks for onset of action, and two-thirds of those on SSRIs fail to achieve~     remission.Compounding this problem, patients with residual symptoms are significantly more~     likely to discontinue treatment or relapse, be hospitalized for medical and psychiatric~     conditions, or die of suicide and other causes. Although eliminating ineffective treatment~     trials would significantly reduce patient suffering and healthcare costs,clinicians currently~     do not have the tools to objectively select treatment based on an individual's likelihood of~     remission. Therefore, there is an urgent need to identify markers predictive of an~     individual's SSRI treatment outcome. Developing this personalized treatment requires~     increased understanding of the relationship between pretreatment neurobiology, SSRI-induced~     biological changes, and the corresponding symptom improvements.~   "
72102|NCT02623179|"~     In this protocol, the investigators are examining the use of a novel pathogen testing~     technology and method of identification of antibiotic susceptibility against the conventional~     C & S testing for patients with both complicated and uncomplicated UTIs. The investigators~     will examine the two modes in terms of objective patient related outcomes, i.e. 1) diagnostic~     accuracy and degree of detail of final analysis; 2) time to resolution of symptoms; 3)~     quality of life as defined by particularly symptomology and bothersomeness of the symptoms;~     and 4) overall cost.~   "
72103|NCT02623166|"~     The investigators propose to test the feasibility and acceptability of community health~     workers (ASHAs and ANMs) being able to treat sick children in the community. There is a~     national policy for treatment for children aged 2-59 months with illnesses such as pneumonia,~     diarrhea and fever by community health workers (CHWs), this policy has not been implemented~     as yet in Haryana. This research will identify barriers and opportunities for use of CHWs as~     treatment sources.~   "
72104|NCT02623153|"~     The choice of neoadjuvant chemotherapy regimen for locally advanced gastric cancer is~     controversial. The aim of this study was to compare the short- and long-term outcomes of~     XELOX regimen with Docetaxel, S1 and oxaliplatin regimen as neoadjuvant chemotherapy regimen~     for locally advanced gastric cancer. The objective of this study is to determine what kind of~     neoadjuvant chemotherapy strategy can make subsequent radical surgery feasible and improve~     overall survival in patients with locally advanced gastric cancer.~   "
72105|NCT02623140|"~     The aim of the Danish Organization for Randomized Trials with Clinical Outcome (SORT OUT) is~     to compare the safety and efficacy of the polymer-free Biolimus-eluting BIOFREEDOM stent with~     a biodegradable-polymer Sirolimus-eluting ORSIRO stent in a population-based setting, using~     registry detection of clinically driven events~   "
72106|NCT02623127|"~     This study aims to investigate the clinical activity of sunitinib in patients with advanced~     thymic carcinoma who have failed chemotherapy.~   "
72107|NCT02623114|"~     The purpose of this study was to identify genetic, brain morphologic, and environmental~     biomarkers that contribute to the pathophysiology of attention-deficit/hyperactivity disorder~     (ADHD).~   "
72108|NCT02623101|"~     Skin cancer is the most common cancer and its incidence is increasing rapidly. The rising~     number of skin cancer may result in long waiting lists for consultation at departments for~     dermatological care and in increasing health care costs. In case of suspicion on skin cancer~     it is of utmost importance to diagnose and treat in an early phase, preferable in a patient~     friendly manner. Skin cancer comprises melanoma and non-melanoma skin cancer (NMSC: basal~     cell carcinoma (BCC), squamous cell carcinoma (SCC) and its precursors actinic keratosis (AK)~     and Bowen disease). As BCC is the most common skin cancer type with an estimated incidence of~     51,000 new tumors in 2015 (The Netherlands), this study will focus on this skin cancer type.~     In case of suspicion on BCC, at present, the pathological examination of a biopsy is the gold~     standard for diagnosing a BCC. With the implementation of non invasive diagnosis by~     reflectance confocal microscopy (RCM) in routine patient care settings the diagnosis can be~     assessed at the first consultation in a non-invasive way and the patient can be treated~     instantly.~      Overall, the aim of this study is to investigate whether reflectance confocal microscopy can~     correctly identify the subtype of basal cell carcinoma.~      Study design: Randomized controlled trail. Comparison with usual care: punch biopsy and~     excision.~   "
72109|NCT02623088|"~     Obstructive sleep apnea syndrome is responsible of endothelial dysfunction, which is a~     independent cardio-vascular risk factor.~      Assessment of pulse wave velocity (PWV) and peripheral arterial tone (PAT) are study~     measurements of arterial stiffness, and are strong predictors of late cardiovascular events.~      This study will compare long term evolution in arterial stiffness (PWV) and endothelial~     dysfunction (PAT) for patients treated by Positive Airway Pressure Therapies.~   "
72110|NCT02623075|"~     Influenza infection in solid organ transplant recipients is associated with increased~     morbidity and mortality compared to non-transplanted controls, due in part to the effects of~     immunosuppression which is necessary to prevent rejection of the transplanted organ. However,~     transplant patients are less likely to produce antibodies when vaccinated and when they do,~     the peak and duration of antibody responses are reduced compared to healthy controls. There~     are considerable differences in the magnitude of these responses, reflecting variability in~     individual responses to the influenza vaccine and to the immunosuppression regimen. The~     investigators hypothesize that chimeric kidney transplant recipients off of immunosuppression~     will have post vaccine immune responses that are comparable to age and gender matched healthy~     controls.~   "
72111|NCT02623062|"~     This study is being conducted in China to provide evidence for inclusion in applications to~     competent authorities that the Compound Sodium Alginate Oral Suspension sachet is effective~     in managing the symptoms of heartburn and acid regurgitation in patients with~     gastro-esophageal reflux disease (GERD).~   "
72112|NCT02623049|"~     Background: The incidence of atrial fibrillation(AF) increases substantially with age and it~     is estimated that more than one third of AF patients are octogenarians. Direct oral~     anticoagulants (DOACs) were found favorable compared to warfarin with respect to efficacy and~     safety ( bleeding) across wide range of ages.~      Nevertheless, the rates of bleeding among elderly patients were shown to increase~     substantially with all anticoagulants. Dose-adjustments of DOAC are not universally performed~     among patients older than 80 years old and currently there is paucity of data regarding the~     actual drugs level among these patients. Accordingly, the investigators sought to investigate~     the drug levels of the different DOACs among real world octogenarians who receiving~     guideline-recommended dosage.~      Methods: A cross sectional, prospective study of 120 hospitalized and ambulatory patients who~     are treated with DOACs for AF.~      DOACs blood levels with be compared between octogenarians (n=70) and younger patient group (~     age≤70 year-old; n=50).The cohort will include: 1)Sixty patients on APIXABAN: 40~     octogenarians and 20 younger than 70 years, 2)Forty patients on RIVAROXABAN: 20 octogenarians~     and 20 younger than 70 years, and 3) Twenty patients treated with DABIGATRAN: 10~     octogenarians and 10 younger than 70 years.~      DOACs Pharmacodynamic analysis will be performed using commercial kits for diluted thrombin~     time(DTT) and anti-factor Xa activity (AFXa). Drug level will be measured at steady state(~     through levels) and at Tmax after at least 4 days of complete adherence for DOAC consumption.~      Study End-Points:The study main objectives are: 1) DOACs levels in octogenarians in~     comparison to patients younger than 70 years and 2)percentage of patients, in each group, who~     have target DTT or AFXa ( predicted) at steady state.~      Potential significance of the study:~      The results of the study may provide new data on DOACs levels in octogenarians and thus would~     either support current recommendations or set the ground for further studies aim to optimize~     DOACs dosage in this vulnerable population.~   "
72113|NCT02623036|"~     The purpose of this study is to use ambulatory blood pressure monitors to investigate whether~     enalapril is superior to lisinopril in managing nocturnal hypertension in patients with~     resistant hypertension currently treated with daytime angiotensin converting enzyme~     inhibitors.~   "
72114|NCT02623023|"~     The purpose of our study is to determine the effect of prophylactic treatment with~     brimonidine/timolol fixed combination (Combigan®, Allergan; Dublin, IRL) or placebo therapy~     (Refresh tears®, Allergan; Dublin, IRL) on long-term IOP measurements in patients receiving~     serial intravitreal injection of 0.5 mg ranibizumab (0.05 mL) with six months follow-up.~     Intraocular pressure measurements will be correlated with changes on ancillary testing~     (Humphrey 24-2 visual field testing and optical coherence tomography (OCT) of the optic nerve~     head (ONH). Our study would be the first large, prospective, randomized double-blind~     placebo-controlled trial to examine the relationship between anti-vascular endothelial growth~     factor (VEGF) therapy and sustained ocular hypertension.~   "
72115|NCT02623010|"~     The study will include 30 elderly patients age 60-85 with primary CNS DLBCL . Induction~     treatment will include Rituximab and high dose methotrexate protocol (containing at least~     methotrexate and one more chemotherapy agent).~      Patients with MRI documented response CR or PR will enter the study protocol maintenance~     phase which will include continous treatment with Ibrutinib 560 mg day until relapse or~     disease progression or occurrence of limiting toxicities~   "
72116|NCT02622997|"~     60 women from the Colposcopy Clinic at the Royal London Hospital will be recruited, having~     been referred following an abnormal cervical screening result.~      Aim Human Papillomavirus (HPV) is very common and can cause cervical cancer in some women.~     There is interest in HPV testing in place of the smear test currently used for cervical~     screening. HPV testing has potential for women to take self-samples.~      These self-samples have up to now mostly been placed into liquid to preserve them before~     testing. Using liquid however, makes it more difficult to collect samples at home due to~     spillage and the logistics of posting. Investigators plan to investigate whether dry samples~     are reliable. Investigators would also like to know if samples can still be used if not~     tested immediately, particularly in warm temperatures. This would prove useful in the~     countries that have found it difficult to set up national cervical screening programmes.~      Trial Design Investigators are asking women to take three vaginal self-samples before~     patients' colposcopy examination. The samples will be two swabs and a third using the HerSwab~     device, designed to make taking a sample easier. Investigators will give women instruction~     sheets with illustrations. Samples, taken in a random order so that all samples have an equal~     chance, will be sent to the laboratory for testing but under different conditions. Samples~     will be either frozen immediately, stored at 25ºC for one week or two weeks and then frozen.~     All samples will then undergo HPV testing. Investigators wish to see if all conditions and~     swabs provide similar amounts of HPV.~      Enrolment is planned to start in May 2015. Sample processing and testing will continue until~     enrolment is complete and for a further month. Smear and biopsy results will be collected for~     up to 6 months to see if they affect quantities of HPV.~   "
72117|NCT02622984|"~     The traditional paradigm that relies upon training physicians and nurses or uses on-site~     interventionists to perform screening, brief intervention, and referral to treatment (SBIRT)~     for alcohol has proven unsustainable in most clinical settings. The Remote Brief Intervention~     and Referral to Treatment (R-BIRT) for alcohol is an innovative telehealth service model with~     potential to improve public health through evidence based counseling for patients who exceed~     the NIAAA low risk drinking limits or have evidence of an Alcohol Use Disorder with~     professional and self-help treatment. For those that are appropriate, the R-BIRT service will~     provide facilitated referrals to specialized alcohol abuse treatment. The service model is~     being studied in the emergency department (ED) setting to demonstrate its utility in a~     medical setting with a very high prevalence of risky alcohol use and Alcohol Use Disorders;~     however, the model is relevant and will be accessible to a broad array of healthcare~     settings, including primary care practices. Our new model, the R-BIRT, challenges the~     prevailing paradigm and offers the promise of not only clinical efficacy but increased cost~     effectiveness as well.~   "
72118|NCT02622971|"~     Volunteers were divided randomly in five experimental groups. VAS (Visual Analogic scale) to~     measure DOMS (Delayed Onset Muscle Soreness) and blood samples was taken before any~     procedure. Then, volunteers performed stretching and warm-up followed by MVC test (isometric~     test in isokinetic dynamometer to measure muscle function). After, volunteers performed the~     exercise protocol (75 eccentric contractions) to lead to muscle fatigue. Immediately after~     exercise protocol (1 minute) and 1 hour, 24, 48, 72 and 96 hours after, blood sample, VAS~     measure and MVC test were repeated. The treatments according to randomisation were performed~     three minutes after exercise protocol and it were performed again in 24, 48, 72h after~     eccentric exercise.~      The variables regarding to muscle function (MVC, DOMS) and the indirect marker of muscle~     damage (CK activity) were monitored in all time points mentioned above (baseline, 1 minute, 1~     hour, 24, 48, 72 and 96 hours after exercise protocol).~   "
72119|NCT02622958|"~     The purpose of the study is to determine whether the PH94B nasal spray is effective for Acute~     Treatment of the symptoms of Social Anxiety Disorder (SAD) in adult men and women. The~     hypothesis is that PH94B nasal spray (.8 micrograms) has a rapid onset of efficacy to improve~     performance and interaction anxiety in patients with diagnosed Social Anxiety Disorder (SAD).~   "
72120|NCT02622945|"~     This study aims to determine whether transcranial direct current stimulation (tDCS) paired~     with speech-language therapy is more beneficial than speech-language therapy alone in acute~     and chronic post-stroke aphasia.~   "
72121|NCT02622932|"~     The purpose of this study is to Investigate the Absorption, Metabolism and Excretion of [14C]~     Anlotinib in Patients With Advanced Cancer patients.~   "
72122|NCT02622906|"~     The angiodysplasias may be responsible for recurrent gastrointestinal bleeding and in some~     cases bleeding remaining inaccessible to endoscopic treatment. Several observational studies~     suggest that treatment with somatostatin analogue would reduce transfusion requirements in~     patients with recurrent bleeding due to angiodysplasia.~      No randomized studies are available. The main objective of this study multicenter,~     prospective, randomized, was to assess the transfusion requirements in patients with~     recurrent bleeding due to angiodysplasia treated by a new analogue of somatostatin,~     Pasireotide, versus placebo.~      Patients with recurrent gastrointestinal bleeding related to angiodysplasias, endoscopic~     treatment failure, with a need transfusion at least 6 red blood cells during the 6 months~     prior to inclusion could be randomized to receive monthly intramuscular injection of~     Pasireotide 60 mg or placebo for a period of 6 months. Patients were then followed for an~     additional 6 months after stopping treatment. A test monthly clinical and laboratory was~     performed during the six months of treatment then quarterly during the six months of~     surveillance.~   "
72157|NCT02622451|"~     This pilot study conducts feasibility and exploratory intervention outcome research that will~     lead to the development of a personalized intervention framework that seeks to preempt the~     progression from early drug use to more chronic abuse and dependency. The study will explore~     moderators representing two frameworks, risk severity and differential sensitivity.~     Moderators will be explored in their ability to influence the differential efficacy of two~     adolescent drug abuse interventions.~   "
72123|NCT02622893|"~     Background: We performed this prospective clinical study to compare the post-operative~     recovery profile of our patients after transperitoneal and retroperitoneal laparoscopic~     nephrectomy techniques. Our primary aim was to compare post-operative epidural analgesic~     consumption of transperitoneal (Group T) and retroperitoneal (Group R) laparoscopic~     nephrectomy patients within the first 24 hours.~      Methods: Forty-four patients scheduled for elective transperitoneal or retroperitoneal~     laparoscopic nephrectomies were enrolled. All patients in both groups received epidural~     catheter, 2.5ml test dose of lidocaine 2% and general anesthesia induction. At the end of the~     surgery, patients were given 1g IV paracetamol and 10ml 0.25% bupivacaine through epidural~     catheters and extubated. In the post-operative care unit, patients started to receive a~     continuous infusion of 0,1% bupivacaine and 1µg/ml fentanyl 5ml/h with patient-controlled~     boluses of an additional 4ml by a patient controlled epidural analgesia (PCEA) device. They~     were prescribed IV tramadol 1mg/kg as a rescue analgesic (Visual analog scale (VAS)≥4). Total~     analgesic consumptions from PCEA devices, VAS scores at rest and during mobilization, heart~     rates (HRs), systolic (SBPs)/diastolic blood pressures (DBPs) at extubation (0th min-basal)~     and at post-operative 30th min, 2nd, 6th, 12th, 18th and 24th hours as well as number of~     patients who require rescue analgesic were recorded. Nausea, vomiting, time to first~     mobilization, return of bowel sounds and hospital stay were also documented.~   "
72124|NCT02622880|"~     The purpose of this study is to evaluate the effect of an immune formula , consumed 10 days~     before surgery , on the number and characteristics of postoperative infections for a period~     of 30 days in a group of oropharynx, hypopharynx , larynx and oral cavity squamous cell~     cancer patients, candidates for surgery.~   "
72125|NCT02622867|"~     The purpose of this study is to evaluate the effects of the probiotic Lactobacillus plantarum~     3547 over different inflammation and immune system markers on a healthy middle-aged group.~   "
72126|NCT02622854|"~     To compare effectiveness in reducing triglycerides between daily plasma exchange and~     glucose+insulin infusion in patients with non-severe acute hypertriglyceridemic pancreatitis~     with mildly elevated triglycerides~   "
72127|NCT02622841|"~     The aim of this study is to assess the feasibility and safety of combining stereotactic body~     radiotherapy (SBRT) and pedicle screw fixation in a 48-hour window for the treatment of~     painful unstable metastases of the thoracic and/or lumbar spine.~   "
72128|NCT02622828|"~     The purpose of this study is to examine whether intervention strategies targeted at the level~     of the environment (e.g. improving access to community based leisure groups, transportation)~     can successfully promote the community participation experiences of community-dwelling older~     adult Manitobans who use wheelchairs in the winter.~   "
72129|NCT02622815|"~     There is a complex, mutual relationship between cancer and thrombosis. Indeed, the tumor has~     the capacity to activate the hemostatic system and this leads to an increased thrombotic risk~     in cancer patients. Even in the absence of clinical manifestations, cancer patients are~     commonly characterized by hemostatic abnormalities, recognized only by laboratory testing,~     which define the 'hypercoagulable state'. Of interest, hypercoagulation has been repeatedly~     reported to be associated with tumor progression and poor prognosis in various carcinomas. On~     the other hand, thrombotic event can represent the first signal of the presence of an occult~     tumor. These findings suggest that the coagulant pathway might play a role in the preclinical~     phase of cancer. The investigators hypothesize that a persistent, subclinical activation of~     the hemostatic system in an otherwise healthy subject, may predispose not only to thrombosis,~     but also to tumor formation and spreading. A major problem in primary cancer prevention is~     the lack of effective predictive markers of the disease. The HYPERCAN is an ongoing~     prospective Italian multicenter study organized around two tightly-interconnected research~     programs aiming to: 1_the assessment of thrombotic markers as a tool for cancer risk~     prediction in two large populations of healthy subjects, i.e. a group of healthy blood donors~     of Bergamo and Milano Provinces and a subgroup of Moli-sani subjects of the Molise region;~     and 2_ the evaluation whether thrombotic markers and/or the occurrence of overt thrombosis~     (or disseminated intravascular coagulation) may be prognostic of cancer disease outcomes~     (i.e. overall survival, progression free survival in metastatic cancer, disease free survival~     in limited disease) in cancer patients with different types of solid tumors (i.e. breast,~     lung and gastrointestinal cancers).~      Therefore, the assessment of cancer risk occurrence in healthy individuals might be useful~     for anticipation of cancer diagnosis. In addition, the results of this study might help to~     evaluate whether thrombotic markers may be prognostic of cancer outcomes independently of the~     disease extension.~   "
72130|NCT02622802|"~     The most important guideline for drug prescription concerning pregnant women is 'drugs should~     be given only if the maternal benefits outweigh the potential risk to the fetus'. However,~     poor data is available on maternal drug disposition and transfer through the placenta, so the~     evidence available for decision making in clinical practice is weak.~      An ex-vivo placenta perfusion model will be used to explore the mechanisms governing~     differences between fetal and maternal drug exposure. The expression of placental~     transporters and cytochrome P450 (CYP) enzymes will be investigated in primary placenta cell~     culture and placental biopsies from different gestational stages to learn how the placental~     drug transfer and disposition is regulated.~      The investigators choose to examine the transfer of paracetamol, erythromycin and~     azithromycin because these drugs are commonly used in human pregnancies and have different~     metabolic pathways.~   "
72131|NCT02622789|"~     An assessment of the effectiveness of Pilates based physical therapy exercises for patients~     with low back pain (LBP) and its influence on spinal movement and patient reported functional~     disability.~   "
72132|NCT02622776|"~     This pilot study is the first step in the development of an new assay that may be further~     tested as a screening method for ovarian and endometrial cancers.~   "
72133|NCT02622763|"~     Intralesional Tolerogenic Dendritic Cells in Crohn's Disease Treatment.~   "
72134|NCT02622750|"~     The purpose of this study is to compare triple-branched stent placement with total-arch~     replacement in the treatment of acute DeBakey I aortic dissection . The investigators design~     optimal effect compare prospective, multi-center, randomized, open-label, parallel-group,~     non-inferiority clinical trial.~   "
72158|NCT02622438|"~     On the basis of published data and our results indicating that oxidative stress may~     contribute to the peripheral skeletal muscle dysfunction in patients with FSHD, investigators~     conducted a pilot randomized double-blind placebo controlled trial to test whether oral~     administration of vitamins and mineral could improve the physical performance of patients~     with FSHD.The result of this clinical trial showed that antioxidants supplementation may~     improve skeletal muscle function of patients with FSHD and suggest that an antioxidant~     strategy adapted may be a relevant therapeutic approach for these patients. Since then,~     patients with FSHD who attend consultation at Montpellier hospital are systematically~     supplemented with antioxidants according their own blood tests.~   "
72135|NCT02622737|"~     Introduction: Population aging is associated with increased prevalence of chronic diseases.~     Parkinson's disease (PD) is the second most common neurodegenerative disease in the world~     population, affecting motor function and functional independence progressively. The~     physiological aging promotes the gradual reduction of body weight, lung function, peripheral~     muscle strength, cardiopulmonary endurance and physical capacity, which increase the~     debilitating effects. Aging, when associated with PD, can induce loss of functionality,~     postural changes, further affecting the nutritional status, worsening the quality of life and~     functional independence of the individual. Although physical therapy is commonly applied with~     a variety of methodologies to PD patients, evidence for the effectiveness of these~     interventions is lacking.~      Objective: The primary objective of the study is to compare the effects of Functional~     Training, Stationary Bike and Exergaming Exercises on proportion of fallers in elderly~     participants with PD. In addition, the secondary objectives are to compare the effects on~     cardiopulmonary endurance, posture, postural control, executive function, quality of life and~     functionality of individuals with PD.~      Methodology: This is an interventional, randomized, blinded, longitudinal and prospective~     study. This research will be conducted in the State Reference Center for Health Care of the~     Elderly (CREASI). The sample will consist of 63 individuals with PD per group. The~     Experimental Group 1 will be submitted to Functional Training, the Experimental Group 2 with~     undergo training with Stationary Bike and the Experimental Group 3 will be submitted to~     exergame training using Xbox360 with KinectTM sensor. All the interventions will be performed~     three times per week, with 50 minutes per session, during 8 weeks.~   "
72136|NCT02622724|"~     In this study effectiveness and safety of a new drug FP-1201-lyo (recombinant human~     interferon beta-1a) is compared to placebo. Investigation is conducted with patients who have~     acute respiratory distress syndrome (ARDS). The new drug is expected to reduce the time which~     a patient need to be on the ventilator and improve patient's chances of survival. Currently~     there are no approved drugs for treating moderate or severe ARDS patients.~   "
72137|NCT02622711|"~     The investigators aim to evaluate the effect of a 6-month intervention (counseling) focused~     on weight loss in a group of overweight or obese women previously treated for early breast~     cancer. Intervention is designed to improve adherence to a healthy diet or/and to increase~     physical activity and decrease sedentary time, taking advantage of a pedometer-like device.~   "
72138|NCT02622698|"~     Investigators performed a randomized controlled trial of 62 patients undergoing elective~     abdominal operations. The treatment group was provided a liquid protein supplement and~     instructed to take a dose three times daily for the first 20 postoperative days.~     Investigators followed patients for six months and compared wound healing and changes in~     weight and laboratory values.~   "
72139|NCT02622685|"~     The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and~     pharmacodynamics of DWP10292 and UDCA in healthy male volunteers after multiple-dosing.~   "
72140|NCT02622672|"~     Diabetes is considered an oxidative stress and a chronic inflammatory disease. Coenzyme Q10~     (ubiquinone) is recognized as a lipid soluble antioxidant. Ubiquinol is a reduced form of~     coenzyme Q10 in our body after food or supplements intakes. Studies have indicated that the~     water-soluble ubiquinol had better antioxidant activity and absorption than lipid-soluble.~     The purpose of this study was to investigate the effects of a water-soluble ubiquinol~     supplement (100 mg/d) on antioxidation and anti-inflammation in diabetes patients.~   "
72141|NCT02622659|"~     Randomized, double blind, double dummy, positive drug parallel comparison, multi-centre~     clinical trial to assess the efficacy and safety of Fuganlin Oral Liquid in children with~     influenza (acute upper respiratory infection).~   "
72142|NCT02622646|"~     Haemophilia A is an inherited bleeding disorder caused by a deficiency of factor VIII~     (FVIII). Patients with severe hemophilia A have a FVIII plasma concentration less than1 IU/dL~     and experience spontaneous and trauma-induced bleeds. Joint bleeds lead to hemophilic~     arthropathy resulting in progressive disability. Patients with moderate hemophilia (FVIII~     level between 1-5 IU/dL) are characterized by fewer hemarthroses, usually trauma-induced, and~     a decreased likelihood of developing arthropathy. This clinical observation led to the use of~     prophylactic FVIII infusions to convert patient´s bleeding phenotype from severe to moderate~     with the result of decreasing or preventing arthropathy.~      Prophylactic regimens may be effective when based on standard fixed-dose protocols (that~     assumes one approach fits all patients) or phenotypic dosing determined by bleeding patterns,~     but do not protect all patients with severe haemophilia from joint damage caused by~     spontaneous or activity-triggered bleeding.~      Individualized treatment in haemophilia A takes into consideration all available information~     about the patient, not only his phenotypic bleeding pattern. Some of the factors that~     contribute to the observed interpatient variability include baseline or residual FVIII~     activity, the pharmacokinetic (PK) profile of the replacement factor, the individual's level~     of physical activity and perceived risk of traumatic bleeding, the presence or absence of~     joint disease, presence of comorbidities and adherence to the dosing regimen.~      Objectives:~      Identify and analyze cause(s) of poor bleeding control in patients on prophylaxis treatment~     and study the clinical impact of a personalized pilot program with a 1 year follow up to~     act on the specific causes.~        1. Describe PK parameters in patients on prophylaxis treatment with Advate®.~        2. Analyze differences in PK parameters in non-controlled vs well controlled patients.~        3. Identify causes of poor clinical outcome in non-controlled patients. Patients'~          individual variables that influence bleeding risk will be studied (individual PK,~          bleeding pattern, joint status, physical activity, life style and patient's adherence).~        4. Study the improvement in clinical outcomes (ABR and Joint status) of a 1 year~          Personalized Prophylaxis Program that acts specifically on the previously identified~          causes of bleeding in non-controlled patients (named: short half-life, high bleeding~          pattern, joint damage, high risk physical activity, active life style and poor patient's~          adherence).~   "
72143|NCT02622633|"~     This study aims to analyze the effectiveness and feasibility of using an implantable system~     that provides epidural electrical stimulation directly to the left prefrontal dorsolateral~     cortex (Brodmann area 9/46) in patients with chronic and refractory Depressive Disorder~     Major.~   "
72144|NCT02622620|"~     Contrast-enhanced MRI is the most common way for evaluating neuroepithelial tumor grading and~     monitoring for tumor recurrence,but the ability to predict tumor behavior remains very~     limited.In this study, the investigators will use multi-b-value diffusion-weighted~     imaging(DWI),three-dimensional arterial spin labeling(3D-ASL) and dynamic contrast-enhanced~     MRI imaging(DCE) to evaluate neuroepithelial tumor grading and monitor for tumor recurrence.~   "
72159|NCT02622425|"~     This randomized, placebo-controlled trial aims to determine the effects of daily~     administration of a carotenoid-producing Bacillus strain PD01 over a 6-week period on~     cardiovascular health biomarkers, microbiota composition and functioning and intestinal~     barrier function in overweight subjects.~   "
72277|NCT02620891|"~     Helium—oxygen mixture(heliox) was suggested to be beneficial in meconium aspiration syndrome~     in previous studies，but the evidence was limited．The aim of the study was to assess the~     effectiveness of synchronize intermittent mandatory ventilation (SIMV) with heliox (70%~     helium and 30% oxygen) on length of ventilation(LoV) and cardiopulmonary protection in~     meconium aspiration syndrome.~   "
72145|NCT02622607|"~     Bone metastases are common in patients with advanced lung cancer and can have devastating~     consequences. Preventing or delaying bone metastases may improve outcomes. Bisphosphonates~     are inhibitors of osteoclast-mediated bone resorption. The current indications for~     bisphosphonates include the treatment of metabolic disorders of bone metabolism (e.g.,~     osteoporosis and Paget's disease), the treatment of hypercalcaemia of malignancy (HCM), and~     the prevention of skeletal-related events(SREs）from malignant bone disease. Clinical trials~     also confirm that bisphosphonates, and zoledronic acid（ZOL) in particular, can prevent bone~     loss from cancer treatment.There is also emerging evidence that the benefits of~     bisphosphonate therapy in the oncology setting are more extensive. This study will evaluate~     whether the addition of ZOL 4 mg every 3 months for up to 1 years in patients with stage~     IIIB/IV lung cancer could reduce the rate of bone metastases ,improve progression-free~     survival (PFS) and overall survival(OS), and delay time to bone metastases .~   "
72146|NCT02622594|"~     This is an investigator initiated, two center, randomized, evaluator-blinded, bilateral~     (right vs. left) study of photodynamic therapy in subjects with facial actinic keratoses.~      Subject's face will be randomized to receive one of four treatments: Treatment 1, Treatment~     2, Treatment 3 or Treatment 4. Treatment 1 will include microneedling performed prior to ALA~     application to their right face and ALA application only to the left face 60 minutes prior to~     BLUE light treatment for 1000 seconds (16 minutes 40 seconds). Treatment 2 will include~     microneedling performed prior to ALA application to their left face and ALA application only~     to the right side of their face 60 minutes prior to BLUE light treatment for 1000 seconds (16~     minutes 40 seconds). Treatment 3 will include microneedling performed prior to ALA~     application to their right face and ALA application only to the left side of their face 30~     minutes prior to BLUE light treatment for 1000 seconds (16 minutes 40 seconds). Treatment 4~     will include microneedling performed prior to ALA application to their left face and ALA~     application only to the right side of their face 30 minutes prior to BLUE light treatment for~     1000 seconds (16 minutes 40 seconds). The face is defined as the surface of the skin~     encompassing the forehead to the hair line and tops of the eyebrows, the entire nasal dorsum,~     the cheeks (bounded by the orbital rim, the anterior border of the ear, the jawline, the nose~     and the chin), the upper lip (not including the vermilion border) and the chin (bounded by~     the lower edge of the vermilion border, the cheek junction and the jawline). The treatment~     areas will be not be occluded. A line will be drawn with a marker that intersects the nose,~     forehead, upper lip and chin in the midline. The left face is defined as the face to the left~     of this line and the right face is defined as the face to the right of this line.~     Posttreatment follow-up visits will be scheduled to occur 48 hours after the treatment and at~     1, 3 and 6 months after the treatment. A blinded evaluator who will remain blinded with~     respect to the randomization will conduct grading of the subject's actinic keratoses and~     photodamage. Tolerability of treatment will be assessed by evaluations of the local skin~     response (erythema, edema, etc.) and will be conducted by an unblinded evaluator.~      Safety will be evaluated by adverse events and local skin responses reported during the study~   "
72147|NCT02622581|"~     Open, non-interventional, prospective, multi-center clinical research platform with the main~     objective to assess molecular biomarker testing, treatment and outcome of patients with~     advanced or metastatic NSCLC in Germany~   "
72148|NCT02622568|"~     The purpose of this study is to investigate topical treatment with Veregen™ 15% ointment as a~     single therapeutic agent and compare it to combination therapy with Veregen ™ 15% ointment~     and a single destructive treatment by cryotherapy for non-facial verruca vulgaris in the~     pediatric population. This novel treatment modality may be useful in the pediatric~     dermatology community offering a less invasive, painless option for treatment of non-facial~     verruca vulgaris.~   "
72149|NCT02622555|"~     Overactive bladder syndrome complicates life for many women. 60-70% of women report~     improvement with treatment but the antikolinergic treatment is often limited by the adverse~     events, for example dry mouth, obstipation and urinary retention. Mirabegron is a~     b3-adrenoreceptor agonist which induces detrusor relaxation. Earlier studies has demonstrated~     similar efficacy comparing Mirabegron with antimuscarinics but a significant reduction of~     adverse events. The aim of the present study is to survey cardiovascular adverse events with~     Mirabegron treatment in a general population suffering from overactive bladder syndrome.~   "
72150|NCT02622542|"~     The purpose of the study is to conduct a randomized controlled trial comparing best medical~     therapy (BMT) alone to BMT with thoracic endovascular aortic repair (BMT+TEVAR) for~     uncomplicated acute type B aortic dissection.~   "
72151|NCT02622529|"~     This study aims to investigate patients' experience of awake surgery of the brain. Patients~     therefore must suffer a disease that makes the technique of awake craniotomy necessary.~      In more detail, the investigators are performing this study in order to investigate the~     influence of fear on pain perception during surgery for patients undergoing awake surgery for~     lesions within the brain. In the event of finding a correlation between fear of the surgery~     and intraoperative pain perception, the investigators aim to reduce possible fear beforehand.~      An additional goal of the investigators is to identify psychological consequences of awake~     craniotomy timely and admit patients to an adequate therapy if necessary.~      There will be no changes regarding the actual treatment of the disease. In case of a consent,~     the patient will receive questionnaires at three timepoints: 1. day before surgery. 2. third~     day after surgery. 3. at 3-6 months postoperatively at the outpatient clinics.~      The benefit of participating in this study is the possibility of detecting psychological~     consequences of awake craniotomy at an early stage. If required, patients will then receive~     treatment timely.~      There are no additional risks. Theoretically there is only a data risk after analysis.~      Patients are free to decide if they want to participate within this study. There are no~     changes in the actual treatment if patients deny participation. In case of participation,~     patients have the right to quit at any time with no reasoning at all.~      During the study investigators are collecting health-related data. If patients quit before~     the study end, data will still be used in pseudonymized form. After 10 years, data will be~     destroyed.~      In case of participation the only duty for the patient is to fill out the questionnaires at~     the above mentioned three time points.~      The investigators conduct this study based on all rules of law regarding data protection.~     Investigators only use the collected data in relation to this study. All investigators are~     under obligation to secrecy.~   "
72152|NCT02622516|"~     Vertigo, dizziness and imbalance are the main symptoms of vestibular dysfunction. They can~     lead to physical consequences, such as the reduction of postural control and falls,~     psychological and / or psychiatric consequences such as anxiety and depression, panic and~     cognitive changes, especially in the elderly. It is known that individuals affected by these~     disorders may improve with the completion of vestibular rehabilitation protocol.Treatment~     protocols can introduce variability of exercises to control the signs and symptoms related to~     vestibular diseases, in order to customize the treatment to affected individuals .~   "
72153|NCT02622503|"~     The purpose of the study is to obtain an overall picture of rituximab treatments and~     treatment responses in RA patients.~   "
72154|NCT02622490|"~     Thirty participants without serious concomitant diseases consume either a high- or a low~     carb. meal either as one single meal or as 5 small portions in the morning and are tested for~     effects on major cardiovascular risk markers and on metabolic rate for three hours on each~     occasion.~   "
72155|NCT02622477|"~     The purpose of the study was to assess the clinical outcome of patients with a mild to~     moderate IPF after a one-year therapy with Esbriet® (Pirfenidone).~   "
72156|NCT02622464|"~     Post-operative scarring on vocal cords is responsible for disorders of the vibration of the~     lining to the original dysphonia can be troublesome for the patient both in his private and~     professional life. There is no currently codified treatment for this type of situation and no~     therapeutic antifibrotic has been effective. Cell therapy is a promising new approach.After a~     liposuction and removing of mature adipocytes (40 to 60%), the remaining cells called stromal~     vascular fraction (SVF) could be isolated. SVF consists of a heterogeneous cell population~     including multipotent stem cells similar to mesenchymal stem cells present in bone marrow.~     The investigators hypothesis is that the trophic and antifibrotic properties of SVF could~     benefit patients with vocal cords scarring responsible for dysphonia.~   "
72160|NCT02622412|"~     Breathlessness is a common and distressing symptom in patients with advanced diseases like~     cancer, chronic obstructive pulmonary disease (COPD), chronic heart failure (CHF) or lung~     fibrosis, which broadly impacts on patients' quality of life and may result in high burden~     for carers.~      This single-blinded randomized controlled fast track trial evaluates the effectiveness of a~     multi-professional breathlessness service in patients with advanced and chronic diseases. The~     intervention group will get immediate access to the breathlessness service whereas the~     control group will receive standard care and get access to the service after a waiting time~     of eight weeks. Primary endpoints are mastery of breathlessness and quality of life, measured~     with the CRQ (Chronic Respiratory Questionnaire) as well as the reduction of symptom burden~     of patients and burden of carers. The evaluation of the cost effectiveness of the~     breathlessness service from the perspective of the German health system is a further study~     aim.~   "
72161|NCT02622399|"~     Caregiver social isolation adversely impacts child health and developmental outcomes; it also~     contributes to suboptimal engagement in health care services and enrichment resources, which~     also elevate risk for poor outcomes in childhood. The proposed pilot intervention aims to~     reduce social isolation and promote engagement in health promoting enrichment and activities,~     by embedding a community health worker assisted forum in a community-driven mobile~     communications (using a platform supported by the company txtwire).~      The investigators propose a two-arm, pilot study enrolling 100 parents of children age 0-5~     years old who reside in the Roxbury, Dorchester, and Mattapan neighborhoods of Boston.~     Participants will be recruited from Boston Medical Center and community sites in Roxbury,~     Dorchester, and Mattapan. The investigators will use quality improvement methods to improve~     the utilization of the mobile communications shared through txtwire to build collective~     efficacy for children and social support and engagement that will optimize family resiliency~     and thereby promote child well-being, as well as, assess the acceptability of the~     intervention, and logistics of the field implementation to ultimately inform an appropriately~     powered RCT. Participants will receive compensation for participation at baseline and~     follow-up interviews.~      The intent of this study is to support developement of mobile social communications to reduce~     social isolation.~   "
72162|NCT02622386|"~     The purpose of this study is to determine the anti-inflammatory effect of high-dose~     riboflavin supplementation on chronic plaque psoriasis. Psoriasis is a common chronic skin~     disorder that affects over 4 million people. There is no cure for psoriasis and treatment is~     directed at controlling patients' symptoms. Amongst patients with skin disease, there is~     significant interest in using complementary alternative medicine and vitamins to treat their~     disease. Previous human case reports suggest that riboflavin, commonly known as Vitamin B2,~     is clinically effective for the treatment of psoriasis; however, they were not conclusive.~     More recent human trials have shown that 400 mg of daily oral riboflavin is a safe and~     well-tolerated medication to administer to humans. For the purpose of this study, the~     riboflavin is used as an investigational drug.~   "
72163|NCT02622373|"~     The purpose of this study is to gain information that may be useful in helping to figure out~     better or newer ways to provide nutrition to babies born premature.~   "
72164|NCT02622360|"~     Developmental dyslexia is a highly heritable disorder in which reading skills are compromised~     despite normal intelligence and appropriate reading instruction. Reading problems in dyslexia~     are thought to primarily originate from weak speech sound representations or poor~     phonological skills. Dyslexia has also been associated with short-term or working memory~     dysfunctions. The current study will address the presence of these problems in dyslexic~     adults by the means of recording auditory and audio-visual mismatch negativity (MMN) and its~     magnetic counterpart (MMNm) to determine neural speech sound discrimination, representations~     and integration of seen and heard language. In addition to analyzing neural processing of~     syllables or (pseudo-)words, a new approach to MEG acquisition and analysis to characterize~     the neural responses during comprehension of complex real-life speech will be used.~     Furthermore, reading, phonological and cognitive skills of these participants will be~     determined with a neuropsychological test battery. The associations between the neural,~     neuropsychological and genetic measures will be studied. This project will illuminate the~     nature of neurocognitive dysfunctions in dyslexia and their relationship with genes.~   "
72165|NCT02622347|"~     The purpose of this study is to test the validity of our in-house chemiluminescence assay for~     measurement of folliclestimulating hormone (FSH) serum levels before and during exogenous~     recombinant FSH (rFSH) administration.~   "
72166|NCT02622334|"~     The purpose of the study is to assess the safety, tolerability, and IOP effects of RO5093151~     following 7 days of topical ocular treatment in patients with primary open angle glaucoma or~     ocular hypertension.~   "
72167|NCT02622321|"~     This multicenter, open-label study will evaluate the safety, efficacy and pharmacokinetics of~     prophylactic emicizumab treatment in participants previously treated with episodic or~     prophylactic bypassing agents. Episodic bypassing agent participants will be randomized in a~     2:1 fashion to receive emicizumab prophylaxis (Arm A) versus no prophylaxis (Arm B) and will~     be stratified across Arms A and B according to the number of bleeds they experienced over the~     last 24 weeks prior to study entry (less than [<] 9 or greater than or equal to [>/=] 9~     bleeds); Arm B participants will have the opportunity to switch to emicizumab prophylaxis~     after at least 24 weeks on-study. Prophylactic bypassing agent participants will switch to~     emicizumab prophylaxis (Arm C) from the start of the trial; enrollment will be extended for~     24 weeks after the last participant has enrolled in Arms A or B or until approximately 50~     participants have enrolled in Arm C, whichever occurs first. Episodic bypassing agent~     participants who previously participated in the non-interventional study BH29768~     (NCT02476942) who were unable to enroll in Arms A or B, or participants on prophylactic~     bypassing agents who were unable to enroll in Arm C, prior to their closure will have the~     opportunity to enroll in Arm D. Like participants in Arms A and C, Arm D participants will~     receive emicizumab prophylaxis from the start of the trial. All participants will continue to~     receive episodic bypassing agent therapy to treat breakthrough bleeds, preferably with~     recombinant activated factor VII (rFVIIa).~   "
72264|NCT02621060|"~     Chlorogenic acid has demonstrated promising effects in the treatment of glycemic control,~     obesity, dyslipidemia, insulin secretion, among others. The above mentioned findings show~     that Chlorogenic acid has an excellent potential for the control of glucose as well as~     insulin secretion and insulin sensitivity.~   "
72168|NCT02622308|"~     This experimental study will look at the effects of INP therapy for two patient groups: 1)~     patients with reduced peripheral circulation and chronic wounds in patients with renal~     disease (dialysis patients); 2) and peripheral arterial disease and leg ulcers. The project~     is designed as a non-randomized clinical trial with single-subject multiple baseline design.~     Also the intervention will be subjected on the same leg for each individual throughout the~     study period. The other leg will act as a control. A baseline measure with patient history~     collection will be performed before a four-week intervention period. These measures include:~     Segmental pulse-volume-recording, Segmental skin perfusion pressure with a laser Doppler~     sensor and a pressure cuff to evaluate reactive hyperemia (Sensilase, Väsamed) and a health~     survey (SF-12/EQ-5D-5L) or similar. After four weeks and eight weeks of intervention, the~     same tests will be repeated. A final follow-up test will be two weeks after cessation of the~     intermittent negative pressure intervention. The study will look at the effect of INP on~     renal failure patients who are given dialysis at a dialysis center located at Oslo University~     Hospital, Ullevål. Otivio AS has supplied the FlowOx devices and provided the necessary~     training to perform this project. Outcome variables assessed before, during and after the~     10-week study period will be: wound healing, quality of life, skin perfusion pressure and~     segmental pulse-volume recording. The aim of this project is to prospectively examine and~     elucidate the effect of intermittent negative pressure therapy on clinically relevant~     measures related to the reduction of peripheral macro- and microcirculation in patients with~     renal failure undergoing dialysis treatment.~      The hypothesis of the study is:~        -  Application of INP in patients with renal failure, by the use of the FlowOx™ device,~          will improve wound healing and peripheral circulation in the foot compared to before~          treatment (baseline) in patients undergoing dialysis treatment.~        -  Application of INP in patients with PAD, by the use of the FlowOx™ device, will improve~          macro- and microcirculation and wound healing in the foot compared to before treatment~          (baseline) in patients with chronic wounds.~   "
72169|NCT02622295|"~     Patients with spinal cord injury (SCI) experience metabolic syndrome, diabetes, obesity,~     pressure ulcers, and cardiovascular disease at far greater rates than the general population.~     A rehabilitation method to prevent or reverse the systemic metabolic consequences of SCI is a~     pressing need. The purpose of this study is to determine the dose of muscle activity that can~     enhance an oxidative muscle phenotype and improve clinical markers of metabolic health and~     bone turnover in patients with SCI. The long-term goal of this research is to develop~     exercise-based interventions to prevent secondary health conditions such as diabetes and to~     ultimately protect health-related quality of life (QOL). Specific Aim 1: To compare changes~     in skeletal muscle gene regulation in individuals who receive high frequency (HF)~     active-resisted stance and low frequency (LF) active-resisted stance for 16 weeks. Hypothesis~     1: The expression of genes regulating skeletal muscle metabolism will support that HF and LF~     both instigate a shift toward an oxidative muscle phenotype. A novel finding will be that LF~     is a powerful regulator of oxidative pathways in skeletal muscle. Specific Aim 2: To compare~     changes in systemic markers of metabolic health and bone turnover in individuals with SCI who~     receive HF or LF for 16 weeks. Hypothesis 2: HF and LF will both reduce glucose/insulin~     levels and HOMA (homeostasis model assessment) score. However, only HF will demonstrate an~     effect on bone turnover (higher serum levels of osteocalcin). Secondary Aim: To measure~     subject-reported QOL using the EQ-5D survey metric. Hypothesis 3: HF and LF subjects will~     show a trend toward improved self-reported QOL after 16 weeks. There will be an association~     between metabolic improvement and improved perception of QOL. These observations will support~     that this intervention has strong feasibility for future clinical translation.~   "
72170|NCT02622282|"~     The purpose of this study is to learn about the impact of text messaging on physical activity~     in persons with risk factors for peripheral arterial disease (PAD).~   "
72171|NCT02622269|"~     Compression of the abdomen during urography with either a patient-regulated compression~     device or conventional compression.~      Evaluation of radiation dose, image quality and patients' experiences~   "
72172|NCT02622256|"~     Cardiovascular (CV) disease is associated with significant morbidity and mortality. In the~     current digital age, needed is a better understanding of how information on social media~     sites may inform our approaches to improving CV health through novel methodologies.~     Investigators propose to study the conversation on Twitter about several CV diseases and~     their associated sequelae.~   "
72173|NCT02622243|"~     The study will assess the duration of protection of single doses of 2 different long acting~     muscarinic antagonists against methacholine induced bronchoconstriction.~   "
72174|NCT02622230|"~     The purpose of this study is to determine the safety and tolerability, and to evaluate the~     pharmacokinetic characteristics of Mianhuahua Flavonoids Tablets after oral administration in~     healthy adult subjects.~   "
72175|NCT02622217|"~     Sleep deprivation is common in anaesthesiology residents. Its effects on technical skills~     have been reported with controversial results. Non-technical skills (team working, situation~     awareness, decision making and task management) contribute to safe and efficient task~     performance. They have a crucial role in anaesthetic practice, especially during crisis~     management. The investigators hypothesized that sleep deprivation was associated with a~     reduced mobilisation of non-technical skills in anaesthesiology residents.~   "
72176|NCT02622204|"~     Our overall hypothesis is that a sudden ambulatory load reduction (caused by HTO) leads to~     changes in cartilage biology that delay or reverse osteoarthritic processes determining the~     clinical outcome and representing an in vivo model for assessing cartilage~     mechanosensitivity.~   "
72177|NCT02622191|"~     The investigators aims to further the understanding of glaucoma pathogenesis and progression~     by utilizing both enhanced depth imaging optical coherence tomography to visualize and~     measure the lamina cribrosa in vivo and segmentation technology to accurately delineate and~     measure the boundaries of the retinal layers. The investigators will elaborate further on the~     key concepts of lamina cribrosa thickness and transynaptic degeneration.~   "
72178|NCT02622178|"~     The main goal of this study is to evaluate the sensitivity and specificity of the NOVA-DN VEP~     protocol and a new software and method (Corda) for the glaucoma detection using optical~     coherence tomography images. Another objective is to evaluate the sensitivity and specificity~     of these tests to differentiate between normal subjects and glaucoma suspects.~      The hypothesis is that the NOVA-DN VEP protocol and Corda analysis results in a high~     sensitivity, specificity and area under the receiver operating characteristic (ROC) curves~     (ROC area) for the glaucoma detection. Another hypothesis is that the NOVA-DN VEP protocol~     and some Corda parameters can differentiate between normal subjects and glaucoma suspects.~   "
72179|NCT02622165|"~     The aim of this study is to conduct an outcome and process evaluation of the REWARD~     intervention, a serious game intervention using reward-based strategies as a main method to~     trigger healthy snacking in Flemish adolescents.~   "
72180|NCT02622152|"~     Directly following cardiac surgery for congenital heart disease; patients are not receiving~     routine turning every two hours to prevent pressure ulcers, because a negative influence on~     hemodynamic parameters is assumed. Investigators have suggested that lateral position may~     have clinically significant effects on oxygenation in cardiac surgery patients.~   "
72181|NCT02622139|"~     Monocentric, prospective interventional study to assess the degree of disease activity with a~     multispectral optoacoustic tomography (MSOT) handheld scanner in patients with Crohn's~     disease or ulcerative colitis.~   "
72265|NCT02621047|"~     This is a multicenter, non-randomized, single-dose, open-label study conducted in male and~     surgically sterile or post-menopausal female participants with stable chronic hepatic~     impairment and in healthy participants matched by age, gender, and body weight to assess the~     effect of hepatic impairment on the pharmacokinetics of alectinib.~   "
72182|NCT02622126|"~     Maternal hypotension is the most frequent complication of a spinal Anesthesia. The prevention~     of spinal hypotension appears more likely to decrease the frequency and severity of~     associated adverse maternal symptoms than the treatment of established hypotension.~     Intravenous fluid administration prior to spinal anesthesia for caesarean section is accepted~     standard practice. The choice of fluid depends on individual and institutional habit,~     material cost (crystalloid is considerably cheaper) and the perceived relative benefits and~     risks. Uncommon but potentially serious adverse effect of colloids is impaired coagulation.~     Although pregnancy is associated with hypercoagulability, little is known about the effects~     of colloid preloading on coagulation in pregnant patients.~   "
72183|NCT02622113|"~     This extension study was designed to evaluate the safety and efficacy of Canagliflozin~     (TA-7284) in combination with Insulin in patients with type 2 Diabetes Mellitus. The~     extension study was an extension to double-blind study of 16 weeks (TA-7284-11)~   "
72184|NCT02622100|"~     The purpose of this study is to evaluate the relative effectiveness and safety of~     Bioresorbable Vascular Scaffold compared to other (drug eluting stents) DES.~   "
72185|NCT02622087|"~     The purpose of this study is to determine whether levels of sex hormones (including estrogen~     and progesterone) influence women's response to treatment for Specific Phobia of spiders. It~     is hypothesised that women will show less relapse of symptoms of spider phobia if they~     receive treatment during a period of high levels of sex hormones.~   "
72186|NCT02622074|"~     The purpose of this study is to evaluate the safety, tolerability and clinical activity of~     pembrolizumab (MK-3475) in combination with six chemotherapy regimens as neoadjuvant~     treatment for participants with triple negative breast cancer (TNBC).~      The primary objectives of this study are: 1) to determine the safety and tolerability and 2)~     to establish a recommended Phase 2 dose for the six combination regimens as a neoadjuvant~     treatments for participants with TNBC.~   "
72187|NCT02622061|"~     This is a multi-centre, single visit clinical investigation involving patients with known PCD~     vs. age matched healthy volunteers. This study involves 1 visit which will last one (1) to~     two (2) hours. Participants (and parent as applicable) will be asked for their consent to~     participate in the study. A brief medical history will be recorded, including information~     such as age, gender, height, weight, race, current medications and living environment. If the~     participant is a PCD patient, they will also be asked about their disease history. Prior to~     performing the nasal measurements, participants will receive instructions from study~     personnel and have the opportunity to practice. All participants will have a brief nasal exam~     and will also have to blow their nose before starting the measurements. Participants will be~     asked to perform nasal nitric oxide measurements using the tidal breathing method followed by~     the velum closed with expiration against resistance method.~      The primary objective is to determine the feasibility and capability of the NIOX VERO to~     discriminate participants with PCD from those that are healthy. Information collected in this~     study will help researchers understand more about the diagnosis of and identification of~     patients with PCD.~   "
72188|NCT02622048|"~     The purpose of this trial is to explore parent-child interactions in parents with and without~     psychosis, and ascertain whether a brief (10 week) supported self-help parenting program~     offered to parents in their own homes can help improve parents' self-efficacy and general~     well-being, as well as interpretations of their parent-child relationship and child behaviour~     in children who are 3-10 years old.~   "
72189|NCT02622035|"~     Background:~      We are involved in testing new behavioral science methods and measures for future research~     projects. In the course of these evaluations, we will also test research questions related to~     parents psychological experiences and how these relate to the responses they have when they~     encounter different types of communication about child health. We are testing multiple~     research questions in the course of this research.~      Objective:~      - To learn about technologies and approaches to use in future research studies.~      Eligibility:~      - Parents (fathers and mothers) of children between the ages of 3-7.~      Design:~      As part of the main study, participants will do four tasks:~      Task 1: Before participants arrive for an in-person visit, they will answer questions online~     about themselves, their child, and their thoughts and opinions related to health.~      Task 2: At the in-person visit, participants will watch a short scene from a movie and answer~     some questions~      Task 3: At the in-person visit, participants will read information about a child health topic~     and answer questions~      Task 4: At the in-person visit, participants will use a virtual reality-based buffet~     restaurant simulation to make hypothetical food choices for their child...~   "
72190|NCT02622022|"~     36 patients with interstitial lung disease will be randomized to 1 weeks treatment with~     morphine hydrochloride as oral linctus 5 mg, four times a day, and 5 mg as needed up to 4~     times a day, or corresponding doses of placebo.~      VAS score for dyspnea will be evaluated after 1 hour and 1 week at follow up. Other~     questionnaires will also be evaluated (GAD-7, K-BUILD, Leicester score)~   "
72191|NCT02622009|"~     Background: The presence of low-grade viral infection in the airways of patients with stable~     chronic obstructive pulmonary disease (COPD) could potentially have implications in the~     pathogenesis and progression of the disease, but previous studies have reported very~     different rates of human rhinovirus (HRV) and respiratory syncytial virus (RSV) genome~     detection in nasal and sputum samples. However, no study has investigated the presence of~     these viruses directly in the lungs by bronchoalveolar lavage (BAL) and bronchial biopsies.~     This study aimed to investigate whether HRV and RSV are present in the lungs of stable COPD~     patients by performing BAL and bronchial biopsies, and relate their presence with disease~     severity.~      Methods: Consecutive patients with stable COPD and control subjects, who underwent diagnostic~     (e.g., lung cancer) and/or therapeutic (e.g., hemoptysis) fibreoptic bronchoscopy in a~     university hospital in Athens, Greece, were enrolled. The collected BAL and bronchial~     biopsies during bronchoscopy were subsequently processed for HRV and RSV RNA detection with~     real-time polymerase chain reaction (PCR). More specifically, the nucleocapsid gene and 5΄~     non-coding region were searched for RSV and HRV detection, respectively.~   "
72266|NCT02621034|"~     In this study the investigators aim to compare the post-operative pain using two single-file~     endodontic rotary systems : Reciproc and One shape.~   "
72278|NCT02620878|"~     The purpose of this study is to determine safety, feasibility and efficacy (with respect to~     sensor- augmented pump therapy) of an Artificial Pancreas (AP) prototype in day and night~     closed-loop control in children and adolescents with type 1 diabetes.~   "
72192|NCT02621996|"~     The individual who is born premature, in addition to a CNS still in accelerated training~     suffers early loss of intrauterine restraint, conditions that promote hypotonia~     characteristic of premature birth. Given this hypotonia associated with musculoskeletal~     immaturity when improperly positioned in the incubator for an extended period, the PN can~     develop joint contractures and postural imbalances that, in most cases, are transitory,~     however can become persistent, causing delay in their Motor development. The aim of this~     study is to analyze the influence of the positioning of preterm infants in the incubator~     hammock on the tone and the myoelectric activity of the rectus abdominis flexor muscles,~     biceps and hamstrings. Study type controlled, randomized, double-blind, to be carried out~     from November 2015 to April 2016 will be obtained two groups, control (in containment nest~     U) and experimental (with hammock) to from randomized samples with premature births in~     Barao de Lucena Hospital or the Hospital das Clinicas, UFPE, the Intermediate Care Units~     (ICU) Neonatal. The sample will consist of 30 premature. To collect, pulse oximeter will be~     used, electromyography, neurological testing Dubowitz and recording behavioral responses.~     Each baby will be accompanied for about 8 hours daytime placement for two days and three~     evaluations performed.~   "
72193|NCT02621983|"~     This study will evaluate the ability of aerobic exercise to improve cognition in people with~     schizophrenia. Participants will be randomly assigned to one of two interventions: (1)~     aerobic exercise class (stationary bicycle, or spin class) for up to 45 minutes three times~     per week for 12 weeks, or (2) balance and stretching class for up to 45 minutes three times~     per week for 12 weeks.~   "
72194|NCT02621970|"~     The investigators aim to evaluate the survival benefit from triple combination of induction,~     concurrent and aduvant chemotherapy versus concurrent chemotherapy alone for high risk~     locoregionally advanced nasopharyngeal carcinoma treated with intensity-modulated~     radiotherapy.~   "
72195|NCT02621957|"~     This study is to assess the pharmacokinetics (PK) of a single dose of pravastatin with and~     without concomitant GDC-0810 administration in healthy female subjects of non-childbearing~     potential. During Period 1 (Day -1 to Day 4) PK parameters of pravastatin will be determined~     in the absence of GDC-0810. During Period 2 (Days 5-28) PK parameters of pravastatin will be~     determined in the presence of GDC-0810.~   "
72196|NCT02621944|"~     Hypoxic-Ischemic Encephalopathy (HIE) occurs in 20 per 1000 births. Only 47% of neonates~     treated with the state of the art therapy (induced systemic hypothermia) have normal~     outcomes. Therefore, other promising therapies that potentially work in synergy with~     hypothermia to improve neurologic outcomes need to be tested. One potential agent is~     melatonin. Melatonin is a naturally occurring substance produced mainly from the pineal~     gland. Melatonin is widely known for its role in regulating the circadian rhythm, but it has~     many other effects that may benefit infants with HI injury. Melatonin serves as a free~     radical scavenger, decreases inflammatory cytokines, and stimulates anti-oxidant enzymes.~     Therefore, melatonin may interrupt several key components in the pathophysiology of HIE, in~     turn minimizing cell death and improving outcomes. The research study will evaluate the~     neuroprotective properties and appropriate dose of Melatonin to give to infants undergoing~     therapeutic hypothermia for hypoxic ischemic encephalopathy.~   "
72197|NCT02621931|"~     The study is being conducted to evaluate two doses of TEV-48125 in adult patients with~     chronic migraine~   "
72198|NCT02621918|"~     We aimed to investigate the effect of a progressive resistance training and aerobic training~     protocol on functional capacity, body composition and quality of life.~   "
72199|NCT02621905|"~     The pharmacokinetics of Sporanox and Lozanoc has not been compared in patients requiring~     anti-fungal prophylaxis or therapy. The present study is designed to compare the~     pharmacokinetics of Sporanox and Lozanoc in patients requiring primary prophylaxis. The~     3-week exposure to each formulation is designed to allow for all participants to reach~     steady-state for each drug, as the time to steady-state can vary.~   "
72200|NCT02621892|"~     This phase 3, 12-week, randomized, double-blind, placebo-controlled, multi-center study will~     evaluate the safety and efficacy of tenapanor in subjects with constipation-predominant~     irritable bowel syndrome (IBS-C) as defined by the ROME III criteria and who have active~     disease as determined after a two-week screening period. Subjects who qualify and are~     randomized into the study will either receive 50mg BID of tenapanor or placebo BID for 12~     week treatment period and then undergo a 4 week placebo controlled randomized withdrawal.~   "
72201|NCT02621879|"~     Bilateral Gluteal Fascio-myo-cutaneous Advancement Flap is a modified technique used in~     Treatment of Recurrent Sacrococcygeal Pilonidal sinus~   "
72202|NCT02621866|"~     The investigators have shown that a single dose of ultraviolet irradiation (as found in~     sunlight) will lower blood pressure for around one hour. They are now testing whether daily~     UVA for two weeks will produce a sustained fall in BP in patients with high blood pressure.~      They will also measure the effect of daily UVA on other cardiovascular risk factors.~   "
72203|NCT02621853|"~     Fatty liver disease including liver steatosis (fat deposition) is a major health problem~     worldwide. It is considered pathological when fat accumulation exceeds 5% of the liver~     weight. Transplantation represents the ultimate treatment for end stage liver disease.~     However, the discrepancy between the demand for donor organs and their availability presents~     one of the greatest hurdles of liver transplantation. Therefore, extended criteria organs~     have to be considered to overcome this shortcoming. Hepatic steatosis is one of the most~     important criteria defining extended-criteria donor liver. In liver transplantation, 'severe'~     fat deposition in donor liver is a major cause of graft failure while 'mild' deposition is~     considered transplantable and 'moderate' deposition represents the gray zone and remains~     difficult to assess. Surgeons usually perform a hepatic steatosis assessment during liver~     donor surgery. However, this method is very subjective and difficult especially when~     inexperienced surgeons or trainees are concerned. Furthermore, it has recently been~     documented that the assessment of steatosis is challenging even in the hands of experienced~     surgeons. Theoretically, a better way to assess steatosis before organ procurement would be a~     non-invasive imaging technique. However, some of these techniques appear to lack the~     sensitivity to accurately quantify hepatic fat content while others are complex, expensive~     and inconvenient to use in the setting of organ procurement. Therefore, liver biopsy remains~     the reference for grading hepatic steatosis. In daily practice the assessment and~     quantification of steatosis by a pathologist during organ procurement is more complex related~     to the lack of availability of dedicated hepatopathologists outside of office hours and in~     smaller community hospitals. A simple and short technique is therefore required to assess~     liver steatosis before retrieval. We have recently demonstrated that Raman spectroscopy could~     provide an accurate, rapid and real-time assessment of hepatic fat content and correlated~     highly with the gold standard (i.e. histopathological assessment of liver sections) in an~     animal model of liver steatosis. The purpose of this study is to validate the use of Raman~     spectroscopy for quantitative assessment of hepatic steatosis. In the hands of the surgeons~     this device can provide an immediate, robust tool to assess the suitability of donor livers~     at the site of retrieval prior to liver transplantation.~   "
74812|NCT02587689|"~     The purpose of this study is to determine whether autologous T cells bearing chimeric antigen~     receptor that can specifically recognize (Mucin 1) MUC1 is safe and effective for patients~     with relapsed or refractory solid tumor.~   "
72204|NCT02621840|"~     The investigators aim to investigate the impact of mandating on-site pre-admission testing on~     cataract cancellation rates in a randomized, prospective, intervention study. Cataract~     extraction is the most commonly performed ocular surgery making surgical training an integral~     component of ophthalmology residency. Patient cancellation of surgery results in a financial~     burden to the institution and a loss of essential educational experiences for the residents.~     An earlier study explored variables impacting cancellation rates and identified incomplete~     pre-admission testing as a major contributing factor to surgery cancellation.~      Patients will be randomized to either 1) the intervention group where on-site pre-admission~     testing will be mandated or 2) the control group, where on-site pre-admission testing will be~     offered but not mandated. Cancellation rates will be collected prospectively and statistical~     analysis utilized to evaluate the significance of intervention.~   "
72205|NCT02621827|"~     This study measures the plasma half-life of 25-hydroxyvitamin D3 (25(OH)D3) in~     non-pregnant-non-lactating women, pregnant women at 30 wk gestational age and at 3 months~     post-partum in women who are exclusively breast-feeding.~   "
72206|NCT02621814|"~     Compared with breast milk and another commercially available formula, infants' growth rate~     after 12 weeks' Friso formula with low glycation feeding will be assessed.~   "
72207|NCT02621801|"~     This prospective, waitlist-control study is evaluating the benefits of a stress management~     and resiliency training program for residents (SMART-R).~      The primary aim of this study is to determine whether the SMART-R is effective at increasing~     coping skills and reducing stress among residents, reflected by changes in constructs such as~     emotional growth, perceived stress, optimism, and coping styles. Objective parameters (heart~     rate, galvanized skin response, sleep duration and quality, exercise and actigraphy) measured~     with the Basis health tracking device will help correlate objective signs to subjective~     report of stress.~   "
72208|NCT02621788|"~     This prospective pilot study evaluated the benefits of a stress management and resiliency~     training program for residents (SMART-R).~      The primary objective of this study is to determine whether the SMART-R effectively reduces~     burnout and stress and enhances coping skills in first year residents. Objective parameters~     (heart rate, galvanized skin response, sleep duration and quality, exercise and actigraphy)~     measured with the Basis health tracking device will help correlate objective signs to~     subjective report of stress.~      The investigators' hypothesis is that the SMART-R, a curriculum designed to teach first year~     residents (in the department of Medicine and Psychiatry) relaxation skills, will enhance~     residents' emotional and physical well being, reduce reports of stress, anxiety, depression,~     and physical complaints, as well as increase overall resiliency.~   "
72209|NCT02621775|"~     The aim of this study was to assess the effects of a 5-week standardized cognitive behavioral~     treatment of stress management conducted via e-learning or face-to-face on patients~     responding to the diagnosis of adjustment disorder with anxiety (ADA) according to the DSM- 5~     (Diagnostic and Statistical Manual of Mental Disorders Fifth Edition) criteria .~   "
72210|NCT02621762|"~     The study aims to determine the effect size of magnesium and bicarbonate supplementation as a~     basis for future randomized controlled trials aiming at the T50-guided improvement of hard~     clinical endpoints in dialysis patients.~   "
72211|NCT02621749|"~     The primary objective of this study is to investigate the impact of continuous renal~     replacement therapy and intermittent renal replacement therapy on microbubble / cerebral~     microemboli generation in a cohort of critically ill patients with dialysis-dependent acute~     kidney injury.~   "
72212|NCT02621736|"~     Monosymptomatic nocturnal enuresis (MEN) is a common problem in children, affecting 7-10% of~     all 7 year olds. MEN is often leading to psychosocial problems because of its burden and~     stigmatism.~      The only available medical treatment option is the vasopressin analogum Desmopressin®.~     However, according to the literature, only one third of patients shows a good treatment~     response, defined as more than 90% of reduced bed wetting. Furthermore, treatment with~     Desmopressin® may lead to psychosocial problems, high costs and potentially dangerous side~     effects like water intoxication and hypertension.~      Copeptin, mirroring arginine vasopressin (AVP), has been shown to be significantly lower in~     patients with MEN compared to controls and lower in patients with severe bed wetting compared~     to patients with only slight bed wetting.~   "
72213|NCT02621723|"~     CURIOS@ is a prospective multi-centre cross-sectional study to investigate readmissions in~     participating units. The data collected is derived from two clinical episodes: the episode~     containing the re-admission and the previous admission (index admission).~      The main aims are:~      Outcomes:~        -  Risk factors to predict preventable readmissions in non-surgical patients~        -  Percentage of subjectively non-preventable and preventable readmissions from patient,~          carer, their nurses and their physician's point of view~        -  Comparison for risk factors on readmissions throughout Europe~        -  Increasing awareness and knowledge for health-care workers on readmissions and its~          preventability~   "
72214|NCT02621710|"~     This study evaluates patient goal achievement and satisfaction in benign hysterectomy.~     Patient's will state their goals prior to undergoing benign hysterectomy, and will receive a~     follow-up questionnaire 3 months post-operatively evaluating their perception of goal~     achievement and overall satisfaction. Goal achievement and satisfaction will be evaluated for~     association with surgical indication, surgical approach (minimally invasive vs abdominal~     surgery), and demographic information.~   "
72215|NCT02621697|"~     Objectives: To evaluate the effects of eight weeks of cognitive motor training (dual task) in~     the risk of falls, balance, independence in basic activities of daily living (BADL) and~     handgrip in institutionalized elderly.~      Methods: The sample was divided in two groups: double task group (DTG), consists of five~     elderly, undergoing a training consists of motor and cognitive activities and control group~     (CG) consists of four seniors who underwent conventional kinesiotherapeutic training, based~     on global stretching and strengthening exercises, both held in 16 sessions.~   "
72297|NCT02620631|"~     This is a prospective, randomized, double-blinded, placebo-controlled study designed to~     examine pain relief following intrathecal morphine sulfate (0.2mg) in patients undergoing~     total knee arthroplasty (TKA) under spinal anesthesia in addition to a femoral nerve~     catheter. The protocol consists of two parts: (1) a prospective patient recruitment study and~     (2) a retrospective assay for endocannabinoids on previously collected specimens.~   "
72216|NCT02621684|"~     The purpose of this pilot study is to evaluate the feasibility of recruiting African American~     prostate cancer survivors to a 12 week physical activity intervention study of three arms~     (aerobics, resistance training, and usual care) through physician referral and community~     advertisement strategies. In addition, the investigators will investigate the acceptance rate~     of the intervention and gather preliminary results on the effect of exercise on African~     American men's urinary and sexual functions. These data can then be used to refine the~     intervention and its implementation model, and to inform the submission of a larger grant to~     the National Institutes of Health.~   "
72217|NCT02621671|"~     Epidemiology seeks to improve public health by identifying risk factors for cancer and other~     diseases and conveying that information to relevant audiences. The audience is presumed to~     understand and use that information to make appropriate decisions about lifestyle behaviors~     and medical treatments. Yet, even though a single risk factor can affect the risk of multiple~     health outcomes, this information is seldom communicated to people in a way that optimizes~     their understanding of the importance of engaging in a single healthy behavior. Providing~     individuals with the ability to understand how a single behavior (obtaining sufficient~     physical activity) could affect their risk of developing multiple diseases could foster a~     more coherent and meaningful picture of the behavior's importance in reducing health risks,~     increase motivation and intentions to engage in the behavior, and over time improve public~     health.~      The proposed study translates epidemiological data about five diseases that cause significant~     morbidity and mortality (i.e., colon cancer, breast cancer (women), heart disease, diabetes,~     and stroke) into a visual display that conveys individualized risk estimates in a~     comprehensible, meaningful, and useful way to diverse lay audiences.~   "
72218|NCT02621658|"~     Colorectal cancer is the third most common cancer diagnosed in both men and women in the~     United States. The death rate from this disease, however, has been decreasing over the last~     20 years. Early detection and removal of pre-malignant polyps is considered to be at the core~     of this change. At the same time, polyp detection is highly dependent on an adequate bowel~     preparation. Froehlich, et al., found that poor bowel preparation is associated with longer~     colonoscopy times, more difficult procedures and a higher rate of incomplete procedures(2).~      Although a Clear Liquid Diet is usually the prescribed diet in most bowel preparation~     regimes, several studies have shown similar results with less restrictive diets.~      Based on the hypothesis that a Full Liquid Diet(FLD) is not inferior to a Clear Liquid~     Diet(CLD), investigators plan to conduct a prospective, randomized trial, in order to compare~     these dietary interventions. The investigators and endoscopists will be blinded to patient's~     diet group.~      Researchers aim to investigate if diet liberalization to a Full Liquid Diet(FLD) is~     associated with similar bowel cleansing as compared with a Clear Liquid Diet(CLD).~     Investigators will compare the performance of these dietary interventions regarding adenoma~     detection rates(ADR), time to cecal intubation(TCI), and colonoscope withdrawal time. In~     addition, the investigators want to assess whether patient's Compliance and Satisfaction is~     similar or superior in the experimental group vs the control group.~   "
72219|NCT02621645|"~     Multi-center open-label randomized controlled trial to assess if early intervention~     (12.0-14.0 weeks) (study group) improves the outcome of TRAP sequence as compared to late~     intervention (16.0-19.0 weeks) (control group). The investigators will randomly assign women~     diagnosed with TRAP sequence diagnosed between 12.0 and 13.6 weeks to an early or late~     intervention group (1:1), using a web-based application and a computer-generated list with~     random permuted blocks of sizes 2 or 4 (www.sealedenvelope.com), stratified by gestational~     age (GA) at inclusion (11.6 -12.6 weeks versus 13.0-13.6 weeks). Analysis will be by~     intention to treat.~   "
72220|NCT02621632|"~     The study intends to investigate a novel compression system termed Socknleg composed of an~     understocking covering the foot with three added stockings extending from the ankle to the~     knee without covering the foot. The novel Socknleg system is compared to a standard class III~     compression stocking.~   "
72221|NCT02621619|"~     To determine the efficacy of IV acetaminophen as an analgesic adjunct to IV hydromorphone in~     the treatment of acute severe pain in the elderly ED patients.~   "
72222|NCT02621606|"~     The purpose of this open-label, 3-part study is to investigate the safety and efficacy of~     [11C]MK-6884 as a Positron Emission Tomography (PET) imaging agent for quantifying muscarinic~     4 (M4) positive allosteric modulator (PAM) receptor density in brain regions of interest. The~     study will enroll healthy participants (Parts I and II) and participants with Alzheimer's~     Disease (AD)(Part III). The primary efficacy hypothesis is that the average intra-subject~     test-retest (T-RT) variability of tracer uptake in brain regions of interest is ≤20%.~   "
72223|NCT02621593|"~     The purpose of this study is to evaluate if, in patients with meibomian gland dysfunction~     (MGD), treatment with the Lumenis M22 Intense Pulsed Light (IPL) system causes a reduction in~     dry eye symptoms post-treatment, compared to pre-treatment.~   "
72224|NCT02621580|"~     Laser therapy is an established method to stabilize and control proliferative diabetic eye~     disease. Questions on the long-term effect on the retina from these treatments remain to be~     answered. The purpose of the study was to evaluate changes in the retina following panretinal~     photocoagulation (PRP) over time, using structural and functional diagnostic tests.~   "
72225|NCT02621567|"~     Bright Light Therapy Efficacy for Depressive Symptoms Following Cardiac Surgery or Acute~     Coronary Syndrome: Pilot Trial (BEAM-P) is a randomized controlled trial (RCT) that seeks to~     assess the feasibility of conducting a full trial which would assess the efficacy of Bright~     Light Therapy (BLT) for improving depressive symptoms post-cardiac surgery or acute coronary~     syndrome.~   "
72226|NCT02621554|"~     The study will investigate whether resveratrol could provide positive effects on memory and~     brain structures and functions in healthy elderly participants.~   "
72276|NCT02620904|"~     Methods: Double blinded, randomized controlled trial with 1:1 allocation of mifepristone or~     placebo at initiation of induction of labor for fetal demise 20 weeks estimated gestational~     age or greater.~      Hypothesis: Mifepristone will expedite time to delivery of fetus among demise patients, when~     compared to placebo, and in conjunction with other pharmacologic methods for induction of~     labor.~      Expected outcomes: The addition of a progesterone receptor modulator will expedite time to~     delivery of the fetus and ultimately improve the experience associated with induction of~     labor for fetal demise.~   "
72227|NCT02621541|"~     Predicting aggressive behavior in the group of nonfunctional pancreatic neuroendocrine tumors~     (NF P-NET) remains a difficult problem in clinical practice. At present, the treatment~     planning in P-NET is significantly restricted by the limited results of conventional imaging.~     In addition, increasing use of multidetector computed tomography (MDCT) and magnetic~     resonance imaging (MRI) is increasing the number of NF P-NETs detected. Somatostatin receptor~     scintigraphy (SRS) combined with anatomical imaging are the conventional modalities in~     imaging of P-NET, but by these methods the diagnostic accuracy still remains compromised.~     Furthermore, recently encouraging results have been obtained in P-NET using 68Ga-labelled~     somatostatin analog, DOTA-1-NaI3-octreotide (68Ga-DOTANOC) positron emission~     tomography-computed tomography (PET-CT).~      The aim of the current project is to evaluate the possibility to enhance the diagnostic~     accuracy by using dual trace functional imaging 18F-labelled fluorodeoxyglucose (18F-FDG) and~     68Ga-DOTANOC PET-CT imaging in patients with NF P-NET. The study consists of 20 patients with~     NF P-NET. The patients enrolled in the study will be imaged 68Ga-DOTANOC and 18F-FDG PET-CT~     followed by surgery or follow-up with endoscopic ultrasonography (EUS) biopsies. The data~     will be collected between autumn 2015 and spring 2018.~   "
72228|NCT02621528|"~     The purpose of this multi-center, non-interventional, prospective, post-market clinical study~     is to collect real world data on patient outcomes and evaluate the procedural success and~     performance of the Lifetech CeraFlex™ occluders for patients with secundum type Atrial Septum~     Defect (ASD), Patent Foramen Ovale (PFO) or Patent Ductus Arteriosus (PDA).~   "
72229|NCT02621515|"~     The effect of nivolumab on symptomatic brain metastases is currently unknown. This phase 2~     clinical trial will be the first to evaluate this intracranial effect in humans, with the aim~     to give these patients the possibility to be treated with anti-PD-1. Besides the objective~     response rate, long term benefits in this patient category will be evaluated by measuring~     survival in terms of progression free survival and overall survival. Furthermore safety and~     tolerability of administration of this drug in patients with symptomatic brain metastases~     will be studied, as this is the first study for nivolumab in this specific patient category.~   "
72230|NCT02621502|"~     The purpose of this study is to to assess the glycemic index and the satiating properties of~     different Quinoa varieties, using a Visual Analogue Scale in a sample of healthy overweight~     subjects.~   "
72231|NCT02621489|"~     The aim of the study is to use Exenatide long-acting release (LAR) [Bydureon] to minimize~     vascular remodeling and neointima formation after Percutaneous Coronary Intervention (PCI)~     and to accelerate stent endothelialisation.~   "
72232|NCT02621476|"~     The investigators propose a randomized encouragement trial to encourage use of the existing~     mail order pharmacy services among diabetes patients with poor adherence to CVD risk factor~     medications in 3 health care systems: Kaiser Permanente Northern California, Harvard Pilgrim,~     and Kaiser Permanente Hawaii.~   "
72233|NCT02621463|"~     Conduct human trials in the endoscopy suite of our continuous positive airway pressure (CPAP)~     ventilator approach using an FDA approved ventilator.~   "
72234|NCT02621450|"~     End stage renal disease (ESRD) is related with increased cardiovascular mortality and~     morbidity. Hypertension (HT) is an important risk factor for cardiovascular disorder among~     hemodialysis (HD) patients. The aim of this study going to investigate the effectivity of~     low-sodium dialysate on the systolic and diastolic blood pressure (BP) levels detected by~     ABPM and interdialytic weight gain (IDWG) in patients undergoing sustained hemodialysis~     treatment.~      Methods: The study will be included 46 patients who had creatinine clearance levels less than~     10 ml/min/1.73 m2 and had been on chronic HD treatment for at least one year. After the~     enrollment stage, the patients will be allocated low-sodium dialysate or standard-sodium~     dialysate for six months via computer-generated randomization.~   "
72235|NCT02621437|"~     Breast cancer can be painful following surgery or can develop later and remain persistent.~     Pain occurrence is frequent with 50% of women developing sequelae pain of varying intensity~     with an impact on the quality of life. One of the priorities of the 3rd French Cancer Plan is~     to preserve quality of life.~      Osteopathy, complementary therapy, may help to reduce inconvenience caused by the disease,~     treatments and their side effects (asthenia, anxiety and pain).~      The main objective is to assess the impact of osteopathic treatment on pain in patients~     following breast cancer surgery. The impact will be considered beneficial if the pain score~     (digital scale) in the intervention group is lower, by at least two points, than the pain~     score in the control group at the end of the study.~      This is a monocentric, randomized, parallel group, single-blind and prospective clinical~     trial.~   "
72236|NCT02621424|"~     The purpose is to is to study if repetitive transcranial magnetic stimulation (rTMS) improves~     cognitive function in patients with neurodegenerative conditions which may manifest as mild~     to moderate cognitive impairment and, in late phase, dementia. This study also intends to~     investigate if the responses to rTMS intervention are either positively or negatively~     correlated with the initial severity of cognitive impairment.~   "
72237|NCT02621411|"~     Substance abuse is a growing problem world wide, and treatment of substance abusers in the~     perioperative period, especially for emergency operation is challenging. The objectives of~     this study are to determine the proportions of substance abusers in the trauma patients~     undergoing emergency operation by preoperative screen, observe the differences of consumption~     of anesthetics and other medications during perioperative period between substance abusers~     and non-abusers, as well as postoperative complications, and explore an optimal scheme for~     substance abusers.~   "
72238|NCT02621398|"~     This phase I trial studies the side effects, best dose, and best way to give pembrolizumab~     when given together with paclitaxel, carboplatin, and radiation therapy in treating patients~     with stage II-IIIB non-small cell lung cancer. Monoclonal antibodies, such as pembrolizumab,~     may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy,~     such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.~     Giving pembrolizumab together with paclitaxel, carboplatin, and radiation therapy may kill~     more tumor cells.~   "
72239|NCT02621385|"~     This study is designed to evaluate the potential effect of administration of tradipitant on~     CYP3A4 using midazolam pharmacokinetics as markers.~      The study will also further characterize the pharmacokinetics of tradipitant.~   "
72240|NCT02621372|"~     Portal hypertension is a common complication of liver cirrhosis that can lead to development~     of esophageal varices (EV). They are abnormally dilated veins within the wall of the~     esophagus that lead to haemorrhage (1). Majority of patients with cirrhosis will develop EV~     at some point, and about third of these patients will have at least one bleeding episode~     because of rupture of a varix . For this reason, screening endoscopy for detection of the~     presence of EV should be part of the diagnostic work-up in patients with cirrhosis. This is a~     very important preventive step for identification of those patients with variceal bleeding~     risk and furthermore, identification of patients in urgent need for prophylactic treatment.~      All guidelines stress on screening endoscopy for early detection of EV in cirrhotic patients~     with portal hypertension. However this approach is limited by its invasiveness and cost~     effectiveness issues of screening endoscopy .~   "
72241|NCT02621359|"~     Helicobacter pylori (H. pylori) infection is a global health problem as it is associated with~     peptic ulcers, chronic gastritis, duodenitis, and stomach cancer.~      Therefore, the eradication of the pathogen is of critical importance to reduce H.~     pylori-related complications .~      However, due to increasing antibiotic resistance, eradication of Helicobacter pylori has~     become more challenging. With a great decline in the eradication rate of standard triple~     therapy for Helicobacter pylori to below 70% in many countries.~      Treatment with triple therapy, which is the most frequently recommended, fails to eradicate~     H. pylori in approximately 20% of cases .~   "
72242|NCT02621346|"~     Mental imagery is effective for improving motor skills as well as increasing muscles strength~     and size. Strength is also maintained after immobilization of a muscles when engaging in~     imagery. This may have important implications for rehabilitation settings and for sedentary~     individuals. We may not be able to get people wot exercise but if they can maintain muscles~     size and strength via imagery this may have beneficial health and functional outcomes.~   "
72243|NCT02621333|"~     This is a prospective, randomized, open, multicenter phase Ⅱ study to evaluate the efficacy~     of cytokine-induced killer cells combined chemotherapy in stage Ⅳ naive EGFR wild-type lung~     adenocarcinoma.~   "
72244|NCT02621320|"~     There is a high prevalence of vitamin D deficiency in Switzerland. In indoor-athletes as well~     as wheelchair users, vitamin D deficiency occurs even more often. It is well established that~     vitamin D deficiency has a negative effect on health. However, vitamin D supplementation in~     individuals with a vitamin D deficiency has a positive effect on muscle performance. In~     recently published studies with able-bodied subjects, it has been shown that a normal vitamin~     D level (>75nmol/L) can only be achieved with a high-dose supplementation of vitamin D.~      The aim of this study is to examine the effect of vitamin D supplementation on exercise~     performance in wheelchair athletes with vitamin D deficiency . All participants with a~     vitamin D deficiency are assigned to the intervention group and treated with 6000 IU of~     vitamin D3 daily over a period of 12 weeks. All participants who have a normal vitamin D~     level will receive placebo treatment (control group). The physical performance is measured~     three times at baseline, after six weeks and 12 weeks. The measurements include a Wingate and~     a dynamometer test.~   "
72245|NCT02621307|"~     The purpose of this study is to determine whether drinks containing Salvia hispanica L~     (Salba) or Flax lower postprandial blood glucose levels and improve appetite in healthy~     individuals.~   "
72246|NCT02621294|"~     Our objective is to determine the dietary requirement of protein for strength and endurance~     exercise trained (more than 4 months training experience) individuals between 18 - 30 years~     of age using the indicator amino acid oxidation (IAO) method. This study will be the first to~     determine the required quantity of protein need per day in strength- and endurance trained~     young adults using the IAO method.~   "
72247|NCT02621281|"~     This is a multi-centers prospective, randomized, controlled trial. This trial will~     investigate the clinical outcome of kidney transplant recipients whose kidneys are under two~     different forms of organ preservation--hypothermic machine perfusion vs. static cold storage.~     Factors during the machine perfusion, such as the pressure, flow rate, and resistance index~     will also be investigated.~   "
72248|NCT02621268|"~     Determine if ICG administered pre-operatively, then imaged intraoperatively using our~     cameras, will aid in the identification of a suspected thoracic nodules, margins, lymph nodes~     and satellite nodules during minimally invasive procedures. The investigators intend on~     enrolling 48 Subjects in this study. The study is focusing on patients presenting with~     suspected thoracic cancers who are considered to be good minimally invasive surgical~     candidates~   "
72249|NCT02621255|"~     Investigator' s study designed to investigate effect of general and regional anesthesia on~     fracture healing.The 40 age and older ASAI-III patients who will operate due to femur~     fracture (except femur neck fracture) will be enrolled in this study after informed consent~     approval.~      Subjects will be divided into two groups by a computerized randomization method. 40 patients~     will be enrolled in this study. General anesthesia will perform for 20 patients. Regional~     anesthesia will perform for 20 patients. Preoperative, 4. week and 12. weeks laboratory test~     which include blood and urine β-C terminal telopeptid (β-CTX), blood alkaline phosphatase and~     osteocalcin will test for all patients. All patients will not use nonsteroid~     anti-inflammatory drugs during study neither perioperative nor postoperative periods.~     fracture healing will be asses with clinical evaluation and laboratory tests.~   "
72250|NCT02621242|"~     As explained in detail in a recently published hypothesis article (Hladik F. A new hypothesis~     on HIV cure. F1000Research, 4:77 (2015)), the investigators hypothesize that NRTI drugs may~     reduce the likelihood of HIV eradication by promoting the survival of cells with integrated~     provirus. In this study, the investigators will test whether daily oral use of two NTRI~     drugs, tenofovir and emtricitabine (Truvada Pill), induces changes in the upper and lower gut~     mucosa that are congruent with supporting this hypothesis.~   "
72251|NCT02621229|"~     The purpose of this multi-center randomized controlled trial is to compare lower calorie~     refeeding to higher calorie refeeding for hospitalized adolescents and young adults with AN.~     The investigators will compare efficacy (achievement and maintenance of clinical remission at~     12 months), safety during hospitalization, and cost effectiveness (including costs of initial~     and re hospitalization, 12 month follow up and safety/adverse events).~   "
74911|NCT02586389|"~     This specimen collection is designed to obtain whole blood and tumor tissue from subjects~     diagnosed with cancer for the purpose of the development of a noninvasive liquid biopsy assay~     using next generation sequencing (NGS).~   "
72252|NCT02621216|"~     Background of the study:~      Percutaneous coronary interventions (PCI) have become mainstay treatment for acute coronary~     artery disease and the number of patients receiving PCI is vastly growing. However,~     relatively little long-term follow-up studies of large real-world clinical samples exist that~     have looked at the real-world effects of PCI treatment and adherence to current guidelines.~      Psychological risk factors are important in determining prognosis after PCI, and undergoing~     PCI may increase the risk of low mood. To date, studies have examined single psychological~     risk factors, without taking into account their relatedness. Moreover, guidelines are~     advocating psychosocial screening in early cardiovascular disease, but the screening test as~     proposed in the prevention guideline has not yet been validated or tested. Although the~     detrimental effects of psychological risk factors on cardiovascular prognosis are known, the~     mechanisms through which they exert these effects are yet unclear. It is to be expected that~     not one but multiple biological (inflammation, endothelial dysfunction) and behavioural~     (coping styles, poor self-care, consultation behaviour) pathophysiological processes play a~     role, and that these processes interact with each other. In PCI patients the mechanisms~     linking psychological risk to poor prognosis are still to be investigated.~      Objective of the study:~        1. To examine the adherence to the prevention and PCI guidelines and the effects thereof on~          long term prognosis in PCI patients.~        2. To evaluate the effectiveness of the psychosocial screening instrument of the European~          Society of Cardiology Prevention guideline 2012.~        3. To examine effects of clustering psychological risk factors on several networks of~          potentially mediating mechanisms and long term outcomes in a large sample of PCI~          patients.~   "
72253|NCT02621203|"~     A multicentre, prospective, observational, hospital-based registry of patients with acute~     heart failure (AHF) those whose care was guided by a cardiologist in Turkey.~   "
72254|NCT02621190|"~     After failure on docetaxel, which has been the standard first line therapy for patients with~     metastatic castration-resistant prostate cancer (mCRPC), several treatment options are~     currently available. In retrospective studies, resistance has been described to two of the~     treatment options, enzalutamide and abiraterone, when a splice variant of the Androgen~     Receptor (AR-V7) is present on circulating tumor cells (CTCs). The investigators hypothesize~     that patients with AR-V7 positive CTCs do have a meaningful response to cabazitaxel.~   "
72255|NCT02621177|"~     This study is a multi-center, randomized, double-blind Phase III clinical trial. The aim of~     the study is to describe the immunogenicity and safety of the trivalent cell culture-derived~     influenza vaccine compared to the trivalent egg-derived influenza vaccine among subjects.~   "
72256|NCT02621164|"~     This study is a multi-center, randomized, double-blind Phase III clinical trial. The aim of~     the study is to describe the immunogenicity and safety of the quadrivalent cell~     culture-derived influenza vaccine compared to the trivalent egg-derived influenza vaccine~     among subjects.~   "
72257|NCT02621151|"~     This trial is to assess the efficacy of pembrolizumab (MK3475) added to concurrent radiation~     and gemcitabine in the management of patients with muscle-invasive urothelial cancer who are~     not candidates for or decline radical cystectomy.~   "
72258|NCT02621138|"~     Population:~      16 children with cerebral palsy, GMFCS 1-3.16 children typically developed, matched for age.~      All children aged 6-12 yrs who understand simple commands.~      Tools:~        1. Polar monitor to record heart rate, attached to chest, in use throughout testing~        2. Dynamometer- for assessing muscle strength.~        3. Weights~      Method:~      Each child will be tested once. Both tools will be demonstrated and tried out before actual~     testing.~      With Polar watch attached:~        1. 5 min sitting at rest,~        2. knee muscle strength assessment with the dynamometer,~        3. 15 minutes rest~        4. Isometric and isotonic knee muscle contraction at 30% of childs` maximal strength as has~          assessed by the dynamometer. The child will asked to perform each for 3 minutes, with 5~          minutes rest in-between All will be perform in both legs.~   "
72259|NCT02621125|"~     This is a double blind, randomized, placebo controlled clinical trial to test the efficacy of~     the antioxidant formulation Fertilix® in lowering the levels of damaged sperm DNA in men~     diagnosed with moderate to high Sperm Oxidative DNA Damage (SODD)~   "
72260|NCT02621112|"~     Hepatitis B virus infection remains an important clinical issue among patients on renal~     replacement therapy. Seroconversion rate as defined by an anti-HBs Ab titer > 10 IU/L after~     intramuscular hepatitis B vaccination (HBVv) remains poor in this cohort. Factors associated~     with inadequate anti-HBs response include older age, diabetes mellitus, obesity and low~     hepatitis B vaccine dose. Various small-scale studies including multiple high dose~     intramuscular vaccination or multiple small dose intradermal vaccination were attempted with~     variable response. Recent study on dose sparing seasonal influenza vaccine delivered via a~     novel intradermal microneedle has demonstrated good immunogenic responses similar to~     full-dose intramuscular vaccination. Imiquimod, a synthetic TLR7 agonist useful for the~     treatment of DNA virus infection, has been shown to improve vaccine immunogenicity. The~     investigators therefore propose a prospective, randomized study to compare the safety and~     immunogenicity of intradermal hepatitis B vaccination with this novel device with~     intramuscular in patients on renal replacement therapy.~   "
72261|NCT02621099|"~     A novel hand held hybrid optical-gamma camera (hereinafter referred to as the camera) has~     been developed and can be used to image radiotracer distribution at the patient bedside. This~     study aims to evaluate the imaging capabilities of the camera in patients attending surgery~     for sentinel lymph node biopsy (SLNB) procedure. It is anticipated that this could improve~     the accuracy and simplify sentinel lymph node detection by providing fused optical and gamma~     imaging.~   "
72262|NCT02621086|"~     This is an initial pilot study to assess and investigate if any adverse symptoms occur (and~     also the severity of any symptoms) after consuming a food-grade Cellodextrin preparation.~     Volunteers will attend a short (around 30mins) medical screening visit, to make sure they are~     suitable to take part in the study. They will then attend 4 study visits (separated by at~     least a week) for around 9.5 hours each time. During the study visits 10, 20, 30, or 50g of~     Cellodextrin will be given as a single oral dose, in a milkshake drink, and any symptoms~     experienced will then be monitored via questionnaires during the study day and for the next~     60 hrs, dietary intake will also be measured over this time.~   "
72263|NCT02621073|"~     To answer the question: Do Prontosan instillations decrease time to wound and fracture~     healing and decrease bacterial load compared to wound vac treatment without Prontosan?, we~     will enroll up to 30 subjects (for an anticipated 20 complete data sets) into this trial. The~     subjects will be split equally into two different groups by randomization. One groups will~     have wound vac therapy with Prontosan, and one group will have wound vac therapy without~     Prontosan. Data related to wound and fracture healing and bacterial load will be assessed~     between the two groups to determine if wound vac therapy with Prontosan speeds up healing~     time and decreases bacterial load.~   "
72267|NCT02621021|"~     Background:~      Cell therapy is an experimental cancer therapy. It takes young tumor infiltrating lymphocytes~     (Young TIL) cells from a person s tumors and grows them in a lab. Then they are returned to~     the person. Researchers think adding the drug pembrolizumab might make the therapy more~     effective.~      Objective:~      To test if adding pembrolizumab to cell therapy is safe and effective to shrink melanoma~     tumors.~      Eligibility:~      People ages 18 70 years with metastatic melanoma~      Design:~      Participants will be screened with:~      Physical exam~      CT, MRI, or PET scans~      X-rays~      Heart and lung function tests~      Blood and urine tests~      Before treatment, participants will have:~      A piece of tumor taken from a biopsy or during surgery in order to grow TIL cells~      Leukapheresis: Blood flows through a needle in one arm and into a machine that removes white~     blood cells.~      The rest of the blood returns through a needle in the other arm.~      An IV catheter placed in the chest for getting TIL cells, aldesleukin, and pembrolizumab (if~     assigned)~      Participants will stay in the hospital for treatment. This includes:~      Daily chemotherapy for 1 week~      For some participants, pembrolizumab infusion 1 day after chemotherapy~      TIL cell infusion 2 4 days after chemotherapy, then aldesleukin infusion every 8 hours for up~     to 12 doses~      Possible filgrastim injection~      Recovery for 1 2 weeks~      After treatment, participants will:~      Take an antibiotic and antiviral for at least 6 months~      If assigned, have pembrolizumab treatment every 3 weeks for 3 more doses. They may have~     another round.~      Have 2-day follow-up visits every 1 3 months for 1 year and then every 6 months~   "
72268|NCT02621008|"~     A self administered 16 weeks plus follow up study to explore the efficacy of mobile phone~     driven apps for stress reduction coupled with guidance for healthy living among obese and~     overweight populations. The Study primary end points are weight of the participants, as well~     as glucose measurements (for subject with diabetes) and blood pressure (of subjects with~     hypertension).~   "
72269|NCT02620995|"~     The study will evaluate the effects of a chronic 30-day treatment with sildenafil citrate on~     penile and systemic microvascular function as well as in blood pressure.~      A control group of normotensive age-matched healthy subjects will serve as a comparator group~     for normal penile and systemic microvascular function.~   "
72270|NCT02620982|"~     This study aims to evaluate the safety and efficacy of low-intensity extracorporeal shock~     wave therapy utilizing the Dornier Aries in the treatment of erectile dysfunction of~     vasculogenic origin.~   "
72271|NCT02620969|"~     Children with chronic kidney disease (CKD) suffer from one of the most devastating diseases~     in childhood resulting in a lifelong need for health care, and a 3 times decreased life~     expectancy. In addition, they have important comorbidities that negatively impact on their~     quality of life and integration in society, jeopardizing their future even after a potential~     transplantation. Retention of uraemic toxins is accepted to play a major role in the~     pathogenesis of the comorbid conditions, but studies in children are lacking. Furthermore,~     there are currently no good tools to evaluate severity and monitor adequacy of treatment,~     resulting in suboptimal management.~      The overall scientific objective of this four years UToPaed IWT-TBM project is to provide the~     clinician with new diagnostic and therapeutic tools for the management of children with CKD,~     based on the improved understanding of uraemic toxicity.~      In the first part of UToPaed, the investigators will associate concentrations of a wide~     variety of uraemic toxins with different comorbidities in CKD children. In this second part,~     a kinetic analysis will be performed to unravel the distribution and transport of the~     different studied uraemic toxins in the body of the patient. The toxins of which~     concentrations are best correlated with comorbidities during the progress of CKD (UToPaed -~     part 1: observational study) and have representative kinetics will be selected as markers.~     These markers will be, together with the comorbidities, further tracked after interventions,~     i.e. starting on dialysis, transplantation, changes in dialysis strategy (UToPaed - part 3 -~     intervention study) in order to validate the different kinetic models.~      From the validated kinetic models (UToPaed - part 2 and 3), an open access user-friendly~     prediction simulator (PAEDSIM) based on patient characteristics and marker concentrations~     will be developed to optimise and individualise the dialysis therapy.~      By providing clinicians with more advanced and appropriate tools to improve management of all~     children with CKD, i.e. better assessment of the degree of renal dysfunction, better~     determination of the ideal time to start renal replacement therapy, and more accurate~     monitoring of dialysis adequacy, the investigators aim to improve neurocognitive and~     psychosocial functioning (short term), growth, maturation into puberty, and social~     integration (median term) and survival (long term).~   "
72272|NCT02620956|"~     BACKGROUND: The aim of this study was to assess pulmonary deposition and distribution of~     radio-aerosol in obese and normal women, using 2-D planar scintigraphy. METHODS: after~     inhaling an aerosol of technetium labeled diethylenetriamine penteacetic acid (99mTc - DTPA)~     with an activity of 1 mCi in a total dose volume with normal saline of 2,5 ml using a~     vibrating mesh inhaler.~   "
72273|NCT02620943|"~     Background: Maternal and child under-nutrition is the underlying cause of death for millions~     across the globe. Anemia during pregnancy is among the leading nutritional disorders with~     serious short and long term consequences to both the mother and fetus.~      Objective: Examine the effect of dietary diversity on maternal anemia, nutritional status and~     key pregnancy outcomes of pregnancy.~      Methods: A prospective cohort study design, involving a total of 432 eligible pregnant women,~     in their second antenatal care visit was conducted between August 2014 to March, 2015. The~     individual dietary diversity Score (IDDS) was used as the exposure variable to select, enroll~     and follow the mothers. Epi-data, SPSS and STATA software are used to enter and analyze the~     data. Chi-square test, independent 't'-test, and GLM are used to calculate risk, association~     and differences between key variables at P < 0.05~   "
72274|NCT02620930|"~     DASAP-HF is an observational prospective single arm study. All patients will be treated~     according to the standard care followed by each center. The protocol requires enrollment of~     consecutive patients from each center, according to eligibility criteria. All patients must~     sign the Patient Informed Consent (PIC) before the enrollment in the study. All patients,~     after the enrollment phase, will be followed for 24 months. Approximately every 12 months a~     clinical follow-up procedure should be performed in each patient. A sleep study will be done~     in all patients at 1 month (or at 3 months) from the enrollment, in order to evaluate the~     performance of the algorithm as a diagnostic tool in this population (primary objective).~     During the 24 months follow-up period, all Adverse Events occurred in the study population~     will be collected (HF hospitalizations, all-cause deaths, ventricular arrhythmias, etc.). At~     the end of the 24 months follow-up, the incidence of clinical events will be evaluated as~     well as its association with the Respiratory Disturbance Index (RDI) values calculated by~     APNEA Scan algorithm (secondary objective).~   "
72275|NCT02620917|"~     This is an observational, multicenter, cross sectional study, collecting clinical and~     metabolic informations about patients treated with CSII in Italy.~   "
72802|NCT02614027|"~     To evaluate the prevalence of lipodystrophy syndrome in patients receiving currently~     available antiretroviral drugs, and the prevalence of associated metabolic syndrome in~     HIV-infected patients with a previous diagnosis of lipodystrophy syndrome, according to the~     severity of fat accumulation and antiretroviral drug use.~   "
72279|NCT02620865|"~     This phase Ib/II trial studies the side effects and best dose of bispecific antibody armed~     activated T-cells when given together with aldesleukin and sargramostim and to see how well~     they work in treating patients with pancreatic cancer that has spread from where it started~     to nearby tissue or lymph nodes (locally advanced) or other places in the body (metastatic).~     Bispecific antibody armed activated T-cells are the patient's own T cells that are coated~     with a bispecific antibody comprising 2 antibodies chemically joined together. These~     antibodies have specific targets and binding properties that may give the T cells a greater~     ability to seek out, attach to, and kill more cancer cells.~   "
72280|NCT02620852|"~     Most physicians still use a one-size-fits-all approach to breast screening in which all~     women, regardless of their personal history, family history or genetics (except BRCA~     carriers) are recommended to have annual mammograms starting at age 40. Mammograms benefit~     women by detecting cancers early when they are easier to treat, but they are not perfect.~     Recent news stories have discussed some of the potential harms: large numbers of positive~     results that cause stressful recalls for additional mammograms and biopsies. With the current~     screening approach, half of the women who undergo annual screening for ten years will have at~     least one false positive biopsy. Potentially more important are cancer diagnoses for growths~     that might never come to clinical attention if left alone (called overdiagnosis). This can~     lead to unnecessary treatment. Even more concerning is evidence that up to 20% of breast~     cancers detected today may fall into the category of overdiagnosis.~      This proposal compares annual screening with a risk-based breast cancer screening schedule,~     based upon each woman's personal risk of breast cancer. The investigators have designed the~     study to be inclusive of all, so that even women who might be nervous about being randomly~     assigned to receive a particular type of care (a procedure that is typical in clinical~     studies) will still be able to participate by choosing the type of care they receive.~      For participants in the risk-based screening arm, each woman will receive a personal risk~     assessment that includes her family and medical history, breast density measurement and tests~     for genes (mutations and variations) linked to the development of breast cancer. Women who~     have the highest personal risk of developing breast cancer will receive more frequent~     screening, while women with a lower personal risk would receive less frequent screening. No~     woman will be screened less than is recommended by the USPSTF breast cancer screening~     guidelines.~      If this study is successful, women will gain a realistic understanding of their personal risk~     of breast cancer as well as strategies to reduce their risk, and fewer women will suffer from~     the anxiety of false positive mammograms and unnecessary biopsies. The investigators believe~     this study has the potential to transform breast cancer screening in America.~   "
72281|NCT02620839|"~     This phase Ib trial studies the best dose and side effects of alpelisib and cisplatin in~     treating patients with human papillomavirus (HPV) positive solid tumor malignancies.~     Alpelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the~     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Giving alpelisib and cisplatin may work better in treating~     patients with solid tumor malignancies.~   "
72282|NCT02620826|"~     This prospective study compares the use of indirect pulp therapy and mineral trioxide~     aggregate pulpotomy for pulp therapy of the primary molar with dental caries approaching the~     pulp.~   "
72283|NCT02620813|"~     There are two purposes of this study:~        1. First, the investigators want to see what the differences are in de novo sebaceous lipid~          production of people with and without acne.~        2. Secondly, the investigators want to know what happens to sebaceous gland de novo lipid~          production before and after treatment with topical tretinoin and oral isotretinoin.~   "
72284|NCT02620800|"~     The purpose of this study is to learn about the safety and potential benefit of metronomic~     5-fluorouracil in combination with nab®1-paclitaxel, bevacizumab, leucovorin, and oxaliplatin~     in treating patients with metastatic pancreatic adenocarcinoma.~   "
72285|NCT02620787|"~     This study will determine the tissue penetration of tedizolid (Sivextro, Merck & Co.), a~     novel oxazolidinone antibiotic, into the extracellular, interstitial fluid of soft tissue in~     diabetic patients with lower limb wound infections. Penetration will be compared with a group~     of healthy volunteer control participants.~   "
72286|NCT02620774|"~     This study will determine the tissue penetration of ceftolozane/tazobactam (Zerbaxa, Merck &~     Co.), a novel β-lactam/β-lactamase combination antibiotic, into the extracellular,~     interstitial fluid of soft tissue in diabetic patients with lower limb wound infections.~     Penetration will be compared with a group of healthy volunteer control participants.~   "
72287|NCT02620761|"~     The investigators will conduct a prospective, blinded, randomized, placebo-controlled trial~     with a sample size of 20 patients in each of the two arms (fenoldopam vs placebo) based upon~     a difference in serum creatinine by one standard deviation. Fluid and salt intake will be~     held constant within clinical parameters and carefully measured. Fenoldopam will be started~     at 0.1 ug/kg/min. If, after 6 hrs there is no decrease in blood pressure, the dose will be~     increased to 0.2 ug/kg/min. This dose will be continued throughout the remainder of the~     study. A study of pediatric patients previously provided to the FDA showed no hypotension at~     a dose of 0.2 ug/kg/min. Fenoldopam will be started 12 hrs before the first dose of~     indomethacin and discontinued 12 hrs after the 3rd dose of indomethacin. Study samples will~     include both blood and urine. The primary outcome will be a reduction in renal dysfunction,~     as determined by creatinine and urine output over the course of treatment. Additional~     outcomes will include determination of known and novel metabolomic urine markers of renal~     dysfunction.~   "
72288|NCT02620748|"~     The purpose of this study is to determine the effect of the early administration of~     intravenous (IV) Tranexamic acid (TA) on perioperative bleeding (as defined by measured~     intraoperative estimated blood loss (EBL), change in pre and post-operative hemoglobin (Hb),~     and frequency of blood transfusions) in women undergoing a myomectomy.~   "
72298|NCT02620618|"~     Intravitreal injection of up to 2 mg of infliximab has proved to be safe in animal models~     (rabbits and primates). These studies have shown no evidence of intraocular inflammation or~     toxicity by clinical, electrophysiological, and histopathological examination for up to 90~     days even with 3 repeated monthly injections. However, the study conducted by Rassi et al was~     the only one to report the development of severe intraocular inflammation in one eye out of~     12 rabbit eyes at 90 days following 3 intravitreal injections (2mg monthly). Unfortunately,~     clinical studies conducted on patients, so far, have raised serious concern about its safety~     and adverse effects.~      These clinical studies have shown various and inconsistent results in terms of the safety and~     efficacy of intravitreal infliximab. These studies were conducted on patients with refractory~     as well as naïve cases of age related macular degenerations choroidal neovascularization (AMD~     CNV), diabetic macular edema (DME), central retinal vein occlusion (CRVO), angiomatous~     malformations, pseudophakic macular edema, and uveitis. The doses used ranged from 0.5mg to~     2mg. The initial study by Theodossaidis et al in 2009 did not report any intraocular~     inflammation in 3 patients receiving 2 intravitreal injections of 1 and 2 mg for refractory~     AMD CNV with 7 months follow up period.(8) Later several clinical studies have reported~     severe intraocular inflammation following intravitreal injections of infliximab in~     non-uveitic patients.These collected data have initiated a call for cautious use of~     intravitreal infliximab.~      On the other hand, studies investigating intravitreal infliximab in uveitis patients have~     shown improvement in vision, reduction in macular thickness on optical coherence tomography~     (OCT), and reduction in inflammation. In this study, we have investigated the safety and~     efficacy of 3 consecutive intravitreal infliximab injections (1 mg/0.05 mL, 6 weeks apart) in~     carefully selected group of patients with refractory uveitis in Behcet's disease.~   "
72289|NCT02620735|"~     While physical activity (PA) appears to play an important role in disease control and the~     promotion of long-term health and well-being of cancer survivors, the large majority of~     breast cancer survivors are not physically active. Addressing this problem requires exercise~     promotion and an additional method of supporting long term exercise adherence. In response,~     an innovative health coaching intervention which uses mobile technology (iMOVE) to promote~     long-term PA in breast cancer survivors (BrCa) was developed. Project description: 107~     inactive BrCa survivors will be randomized to receive a 12-week exercise program (CONTROL) OR~     a 12 week exercise program plus a concurrent health coaching program (iMOVE) consisting of~     telephone-based coaching sessions and interactive software delivered through a smart-phone~     and Fit-bit (wearable fitness technology) (INTERVENTION). Information on the feasibility and~     acceptability of the methods and intervention and examine the impact on fitness (primary),~     patient-reported, anthropometric, and physical (secondary) outcomes will be collected. Impact~     and relevance: PA has increasingly been identified as a modifiable factor that has the~     potential to impact cancer outcomes and improve quality of life. iMOVE is an innovative~     intervention with the potential to promote and maintain physical activity for breast cancer~     survivors. This study will be the first step in the evaluation of iMOVE and will help to~     determine whether a larger randomized controlled trial is needed.~   "
72290|NCT02620722|"~     This study evaluates a novel technique for measuring the minimum pressure necessary to~     achieve a bloodless surgical field, known as a patient's limb occlusion pressure (LOP).~     Patients will have tourniquets applied to their arms and legs and LOP will be measured using~     the new technique and a gold standard Doppler ultrasound technique.~   "
72291|NCT02620709|"~     This project is a community-engaged, randomized control trial of hula, the indigenous dance~     form of Native Hawaiians (NH), among 250 NHs with hypertension living in Hawaii and~     Washington State. Investigators will compare the effects of a 6-month intervention, called~     the KaHOLO Program, delivered by trained peer educators to a wait-list control condition on~     blood pressure and 10-year cardiovascular risk. The intervention will be comprised of hula~     plus hypertension self-care education program. Investigators will also examine the mediating~     effects of health behaviors, self-regulation, psychosocial, and socio-cultural factors on~     blood pressure reduction. The ultimate goal is to develop and test a culturally-appropriate,~     acceptable, and effective intervention that can be delivered and sustained in community~     settings.~   "
72292|NCT02620696|"~     Hypergastrinaemia induced by proton pump inhibitor (PPI) treatment is reported to cause~     ECL-cell and parietal-cell hyperplasia, and rebound hyperacidity and dyspepsia after PPI~     withdrawal.~      The objective of the study was to determine the dosage regimen of netazepide, a gastrin/CCK2~     receptor antagonist, required to inhibit the trophic effects of PPI-induced~     hypergastrinaemia.~      Six groups of 8 healthy subjects participated in a randomised, double-blind,~     placebo-controlled exploratory study of esomeprazole 40 mg daily for 28 days, and netazepide~     1, 5 or 25 mg, or placebo daily during the last 14 days of esomeprazole dosing, or 14 days~     after esomeprazole withdrawal. Serum gastrin and plasma chromogranin A (CgA) were measured~     regularly from study start until at least 1 week after the last dose. Dyspepsia was monitored~     after esomeprazole withdrawal.~   "
72293|NCT02620683|"~     Anecdotal reports suggest buffering lidocaine with epinephrine just before intraoral~     injection reduces time of onset, results in a deeper anesthetic effect, without the sting~     with injection from a low pH. Additional data are needed to establish clinical important~     outcomes such as the peak blood level of lidocaine as compared to the non-buffered drug~     combination.~      Clinical pilot studies are proposed as the start of a series of investigations to support or~     modify the use of the buffered anesthetic for intraoral procedures.~   "
72294|NCT02620670|"~     Obesity is a major public health problem on the world and Mexico too, in addition the obesity~     develops chronic non-communicable diseases (NCD) such as type 2 diabetes mellitus (T2DM) and~     cardiovascular disease (CVD). So the phenomenon of obesity is studied in many investigations~     to know their causes, prevention and treatment.~      Participation of body fat and especially in the visceral area is well documented in the~     appearance of T2DM; however, it is quite interesting that found that not all individuals with~     visceral obesity have impaired glucose tolerance, prediabetes or T2DM; but they are presented~     as normoglycemic individuals with obesity.~      Currently, it is recognized that physical activity influences the concentrations of plasma~     glucose, and promoting their utilization in peripheral tissues, to be used as an energy~     source, through the regulation of glucose transporters in tissues such as the muscle, so~     might influence the glycemic variability, and therefore is of interest to this study to~     evaluate the effect of physical activity of moderate intensity on the glycemic variability of~     individuals with visceral obesity and normal weight without alterations in tolerance glucose.~   "
72295|NCT02620657|"~     Approximately 3000 advanced NSCLC patients, who fulfil the inclusion/exclusion criteria, will~     be recruited by 30 sites in North China.~   "
72296|NCT02620644|"~     Neuroretinal damage in diabetes produces functional abnormalities such as the loss of~     chromatic discrimination,contrast sensitivity and dark adaptation. These alterations can be~     detected by means of electrophysiological studies in diabetic patients with diabetes duration~     of less than two years, i.e. before microvascular lesions can be detected in ophthalmologic~     examination. Neurodegeneration seems to be a generalized process that occurs throughout the~     macula and is not confined to local abnormalities, in the cases with visible signs of~     retinopathy.~      The debate is still open as to whether diabetic retinal neuropathy is the effect of vascular~     diabetic retinopathy or is primarily caused by direct neurologic damage from chronic~     hyperglycemia. The hypothesis that diabetes causes retinal neuro-pathy independent of~     retinopathy is intriguing and potentially links retinal neuropathy to other diabetic~     neuropathies.~      Neuroretinal degeneration initiates and/or activates several metabolic and signalling~     pathways which participates in the microangiopathic process as well as in the disruption of~     the blood-retinal barrier which is a crucial element in the pathogenesis of diabetic~     retinopathy.~      Retinal ganglion cells are the earliest cells affected and have the highest rate of~     apoptosis. However, an elevated rate of apoptosis has been also observed in the outer nuclear~     layer (photoreceptors) and in the retinal pigment epithelium (RPE). The use of spectral~     domain OCT (SD-OCT) makes it possible to measure the thickness of individual layers at higher~     resolution and indicates that the thinning of the inner retina in the macula is primarily due~     to loss of ganglion cells.~   "
72301|NCT02620579|"~     Chronic shoulder pain is a common, costly, and disabling problem for society. The~     identification of factors predictive of the development of chronic shoulder pain is necessary~     to develop innovative and effective treatments to reduce the societal impact of shoulder~     disorders. In previous work the investigators identified a genetic and psychological subgroup~     that robustly predicted heightened shoulder pain responses in a pre-clinical cohort and poor~     12 month shoulder pain recovery rates in a clinical surgical cohort. In this follow-up study~     the investigator proposes to test how interventions tailored to the high risk subgroup affect~     pain responses in a pre-clinical cohort.~      The optimal theorized match for the identified high-risk subgroup is a combination of~     personalized pharmaceutical and education interventions. This combined personalized~     intervention versus a placebo pharmaceutical and general education intervention group is the~     primary comparison of interest. Also, an evaluation of the individual effect of personalized~     pharmaceutical and educational interventions will be part of the study. Such comparisons will~     provide important information on what the active portion of the combined personalized~     intervention may be.~   "
72302|NCT02620566|"~     To our knowledge there is still no study comparing the local wound infiltration by itself~     without ilio-inguinal and ilio-hypogastric nerve block and caudal anesthesia. The aim of this~     study was to evaluate anesthesia and recovery profile in pediatric patients after inguinal~     hernia repair with caudal block (CB) or local wound infiltration (LWI).~   "
72303|NCT02620553|"~     A dose with proven drug bioavailability to the immune system for use in a phase II/III~     primary T1DM (type 1 diabetes) vaccination trial (POINT study) in genetically at risk~     subjects.~      Study Design Randomized, placebo-controlled, double-blind/double-masked, multi-center, dose~     escalation primary intervention pilot study.~      Accrual Objective 25 (3:2 randomization to active and control arms)~   "
72304|NCT02620540|"~     The purpose of this prospective single center study is to investigate if a developed~     algorithm is more accurate than the Broselow Tape (BT). For this study 500 patients are~     required to collect anonymized data (length, weight, age, anaesthesia material used during~     anaesthesia) for achieving a power of 80% during statistical analysis. The main hypothesis~     ist that the algorithm has a better accuracy than the BT.~   "
72305|NCT02620527|"~     Foundation Medicine Inc. (FMI) is interested in studying the concordance of genomic~     alterations between primary and/or metastatic surgical biopsies, and circulating tumor DNA~     (ctDNA) within different solid tumor types and has been developing an assay in order to do~     so.~   "
72306|NCT02620514|"~     The purpose of this is to formally assess health literacy and medication adherence in~     participants with Inflammatory bowel disease (IBD). The study also aims to improve medication~     adherence, health-related quality of life, and disease activity through a 24-week~     intervention.~   "
72307|NCT02620501|"~     Patients will be randomized to a placebo or study group who will receive topical lidocaine~     prior to EGD. Amount of medication used, recovery time, patient/endoscopist satisfaction will~     then be assessed.~   "
72308|NCT02620488|"~     This pilot study will assess the effects of a brief laboratory-based guided imagery procedure~     on responses to pain in patients with sickle cell disease (SCD) and healthy controls.~   "
72309|NCT02620475|"~     The purpose of this study is to evaluate the effect SutureSafe dressings have on reducing~     scarring from an incision following an elective abdominoplasty (tummy tuck) procedure. The~     scar will be evaluated using subjective clinical assessment criteria. Each participant in the~     study will serve as a control and experiential study, since have of the incision will be~     treated with the gold standard of care and the other half with SutureSafe dressings.~   "
72310|NCT02620462|"~     Knee osteoarthritis (KOA) is one of the leading causes of lower limb disability among the~     elderly and can cause loss of knee joint proprioception that contributes towards~     deterioration of postural balance. Maintaining a good postural stability is essential while~     performing everyday functional activities and to avoid falls. Exercise training has been~     reported to reduce pain as well as improve performance of functional tasks in patients with~     KOA however compliance to exercise can be challenging due to pain, lack of motivation and~     traditional nature of exercise that can easily overtax patients. Furthermore, there are not~     exercise programs that are specifically designed for patients with KOA in order to address~     lost knee joint proprioception. Recent studies have also demonstrated that visual feedback~     during exercise can enhance the benefits of exercise training. Therefore, the aim of the~     proposed study is to implement an interactive sensor-based exercise training to improve~     postural balance, gait and activities of daily living in patients with KOA.~   "
72311|NCT02620449|"~     The purpose of the study is to learn more about how common food additives can affect~     phosphorus metabolism in people with normal kidney function and people with chronic kidney~     disease.~   "
72312|NCT02620436|"~     Objectives: The primary objective of this evaluation is to determine if well-constructed and~     well-resourced Maternity Waiting Homes are utilized by pregnant women living at distance from~     the health facility and are associated with improved pregnancy outcomes, particularly for~     women living farthest from health facilities. Findings from this evaluation will be provided~     to policymakers formulating policy decisions affecting the implementation of the Maternity~     Home Model and, if applicable, will be used as evidence for programmatic decisions made by~     the Ministry in deciding to take this model to scale beyond the districts proposed for this~     project.~      Primary Impact Evaluation Question: Does the Minimum Core Maternity Home Model increase~     access to high quality intrapartum care among mothers living more than 10 km from the~     facilities compared to the standard of care?~      Study Design: We propose a quasi-experimental pre-post design wherein one implementing~     partner (BU/ZCAHRD) will use a cluster-randomized matched pair design and one implementing~     partner (University of Michigan/Africare) will utilize a matched-pair, two-group comparison~     design with no randomization.~      Methods: Using mixed-methods, we will collect data from two main sources: 1) Household~     Surveys and 2) In-depth Interviews. A quantitative household survey will be conducted among~     2,400 randomly-selected households at both baseline (2015) and endline (2018) among recently~     delivered women (delivered in the last 12 months) living more than 10 km from the~     intervention and comparison facilities.~      15% of the households enrolled in the study will be randomly selected to participate in an~     In-Depth Interview (IDI). Content will include perceptions of labor and delivery practices,~     barriers to accessing care, knowledge and awareness of MSs, perceptions of the quality of MS,~     perceptions of respectful care at the facility, post-natal care, costs, and perceptions of MS~     ownership.~   "
72313|NCT02620423|"~     The purpose of this Phase 1b study is to investigate whether intravenous administration of~     REOLYSIN® in combination with chemotherapy and pembrolizumab is effective and safe in the~     treatment of pancreatic adenocarcinoma.~   "
72842|NCT02613507|"~     The purpose of this study is to determine whether Nivolumab improves life expectancy compared~     to Docetaxel in Subjects with Advanced or Metastatic Non-small Cell Lung Cancer who have~     failed prior platinum-based doublet chemotherapy.~   "
72314|NCT02620410|"~     The RELAX-OAB (Treatment of REfractory Overactive BLadder with the AXonics Sacral~     Neuromodulation System) is a post-market clinical follow-up (PMCF) study designed to confirm~     the performance of the Axonics Sacral Neuromodulation (SNM) System as an aid in the treatment~     of the symptoms of overactive bladder (OAB) as well as capturing patient satisfaction and~     quality of life data.~   "
72315|NCT02620397|"~     This trial is designed as a prospective, multi-center, observational study of all-comers~     eligible adult subjects presenting to participating emergency departments with symptoms~     suggestive of acute coronary syndrome (ACS)~   "
72316|NCT02620384|"~     The primary objective of the study is to determine efficacy of metolazone as synergistic~     therapy with Lasix in patients with acute decompensated heart failure. This will be a single~     center double blinded randomized placebo- controlled pilot study of the addition of 5 mg of~     metolazone per day for 2 days compared to placebo in patients admitted with acute~     decompensated heart failure.~   "
72317|NCT02620371|"~     This study aims to compare the analgesic efficacy and safety of local bupivacaine alone~     versus bupivacaine plus ketamine in ultrasound guided modified Pecs block in patients~     undergoing breast cancer surgery.~   "
72318|NCT02620358|"~     This study compares two opposite strategies of weaning from Mechanical Ventilation. One of~     them is Low Pressure Support Ventilation during 30 minutes and the other is T-Tube for 2~     hours. The aim of the study is to know witch one has a higher successful extubation rate.~   "
72319|NCT02620345|"~     Dydrogesterone Multivitamin Nature treatment of fibroids in women of reproductive age and~     women pregnancy to lost the size fibroids.~   "
72320|NCT02620332|"~     Type 1 diabetes is an autoimmune disease in which the insulin secreting βcells of the~     pancreas are destroyed such that the patient is reliant on injection of insulin to adequately~     control blood glucose levels for the remainder of his/her life. The autoimmune process~     targets proteins in beta-cells which are termed autoantigens. This is a Phase 1 study using a~     novel investigational medicinal product (IMP) known as MultiPepT1De in a study of safety and~     tolerability of administration in patients with recent onset Type 1 diabetes. MultiPepT1De is~     a mixture of peptides from islet auto antigens. The mixture has been designed to induce or~     restore immunological tolerance to the beta-cell and thus control or limit autoimmunity to~     protect beta-cells~   "
72321|NCT02620319|"~     The objective of this project is to determine whether biodegradable polydioxanone stents are~     efficient in the treatment of adult patients with tracheobronchial stenoses.~   "
72322|NCT02620306|"~     The purpose of this study is to evaluate the Efficacy and Safety of Fimasartan in patients~     with hypertensive diabetic chronic kidney disease.~   "
72323|NCT02620293|"~     This is an open label, non-comparative investigation to determine the tolerance of Eczema~     Repair Emollient on healthy subjects with dry/atopic and very dry/atopic skin.~      The Eczema Repair Emollient will be applied for 47 hours under occlusion. Skin tolerance will~     be assessed immediately and 1 hour, 24, 48 and 72 hours after patch removal.~   "
72324|NCT02620280|"~     This study that aims to evaluate the addition of MPDL3280A (atezolizumab) to carboplatin and~     nab-paclitaxel in patients with locally advanced triple negative breast cancer. compared to~     the control arm of carboplatin and abraxane. Half of participants will receive MPDL3280A in~     combination with carboplatin and abraxane, while the other half will receive only carboplatin~     and abraxane.~   "
72325|NCT02620267|"~     Individuals with schizophrenia have difficulties in functioning in the community. No one~     really knows what factors determine how well patients manage in the real world. The purpose~     of this pilot study is to try a new approach to improving a potential determinant of good~     community functioning, namely how we process sounds. Specifically, we propose to examine the~     benefit of transcranial direct current stimulation (tDCS), a new tool that is being developed~     as a safe and non-invasive neurostimulation method, for improving processing of sounds.~     Transcranial direct current stimulation involves placing a wet sponge electrode on the head~     and one on the arm. Electrical current from a device powered by a 9-volt battery will flow~     from one electrode to the other. A small portion of the current will pass through the skull~     and stimulate the brain. This procedure is non-invasive and painless and it results in~     increase or decrease of spontaneous neuronal firing in the brain. Neurons are brain cells~     that send electrochemical messages to each other. Its safety and beneficial effect on mental~     functions has been demonstrated in healthy individuals and several clinical populations.~      The purpose of this study is to determine if transcranial direct current stimulation can~     effect how we process sounds.~   "
72326|NCT02620254|"~     The Mast Cell Connect Registry is a voluntary, observational database that will capture~     demographic, socioeconomic, and disease information directly from patients with mastocytosis~     via a secure web-based tool. No experimental intervention is involved.~   "
72327|NCT02620241|"~     The study evaluates the effect on gastro-oesophageal reflux (GOR) of infants sitting in a~     stable upright position during 20 min. This is an addendum to the previous study with record~     number clinical trials.gov NCT02124863~   "
72328|NCT02620228|"~     This clinical device investigation is conducted by performing liver biopsies using the BIP -~     Biopsy Tool. The aim is to assess the feasibility of bioimpedance spectroscopy based biopsy~     tool guidance method and test how well BIP biopsy system is able to distinguish liver tumours~     from surrounding tissue. In addition, user feedback is obtained to improve the usability of~     the investigational device. The study does not affect the traditional treatment procedure and~     only the patients in clinical need for diagnosis by liver biopsy are included on voluntary~     basis. The invasive products used in actual biopsy operation are designed so that their~     performance is essentially equal to the currently used biopsy devices, the only difference is~     the measurement capability of biopsy needle and connection to measurement device.~   "
72341|NCT02620059|"~     The aim of this study is to examine the impact of lifestyle intervention on postpartum weight~     loss. So the investigators will have two groups in this study. In Experimental group women~     will receive the Healthy Lifestyle Intervention. This intervention will have been delivered~     during 12 weeks. In Control group women will receive general information via pamphlet about~     postpartum period and tips for stress management.~   "
72342|NCT02620046|"~     The purpose of this study is to obtain long term safety and tolerability data of vedolizumab~     subcutaneous (vedolizumab SC) in participants with ulcerative colitis (UC) and Crohn's~     disease (CD).~   "
72329|NCT02620215|"~     About 1 in 6 deliveries in KKH are induced with prostaglandins. Inpatient induction can be a~     lengthy process especially when cervical priming is required. Although mechanical method of~     induction of labour (IOL) is established, its use in Singapore is uncommon. Systematic~     reviews comparing mechanical method against pharmacological and surgical IOL showed that~     mechanical method has similar efficacy with lower risk profile. As IOL is a common obstetric~     procedure, a revisit on the techniques is warranted. A multi-centre randomised controlled~     trial concluded that both cervical ripening balloon and prostaglandin are effective and~     complementary methods for IOL in uncomplicated singleton pregnancies, but did not examined~     the effects of pain.~      The investigators propose to evaluate the adverse events in the 12 hours after CRB or 1st~     prostaglandin insertion, its efficiency in term singleton IOL in Singapore context and test~     the acceptability of women in Singapore in using the CRB as an alternative method of~     induction of labour while using a non-incremental balloon filling regime. Currently, there is~     no efficient method of induction that can be used safely in an outpatient setting. Through~     this study, the investigators hope to show that there are no major adverse events in the 12h~     after patients are induced with CRB, this potentially supports outpatient IOL with CRB which~     can reduce hospitalisation and medical costs. A non-incremental balloon filling regime will~     decrease time delays and may increase patient satisfaction during its use in induction of~     labour.~   "
72330|NCT02620202|"~     The main aim of the WESTCOR study is to~        -  investigate the ability of two high sensitive cardiac troponin (hs-cTn) assays to~          diagnose acute coronary syndrome and predict prognosis in different patient populations~          (e.g. gender, age and co-morbidity)~        -  to validate the suggested 1 hour protocol for rule in and rule out of acute coronary~          syndrome for two hs-cTn assays in an unselected chest pain population~        -  to investigate different biomarkers ability to predict long term prognosis after~          hospitalization for chest pain~   "
72331|NCT02620189|"~     Preliminary data suggest that up-regulation of Interleukin -17 (IL-17) and the T-helper 17~     (Th17) pathway occurs in rheumatoid arthritis (RA) patients on anti-Tumour Necrosis Factor~     (TNF) therapy who demonstrated an incomplete clinical response. A deeper understanding of~     this is required in order to determine whether IL-17 or the Th17 pathway is a valid target~     for intervention in this population to improve response outcome.~      The study objective is to observe biologic naïve RA subjects on anti-TNF therapies and take~     measurements of peripheral blood and synovial tissue to assess differences in the IL-17 and~     Th17 pathways between responders and non-responders. The aim of the study is to test if~     increased Th17 pathway activity is present in subjects who do not respond clinically to~     anti-TNF therapy.~      Clinical assessments, synovial bio-markers and ultrasound will be used as determinants of~     clinical response. The study may identify disease characteristics that determine which~     subjects may be more likely to respond to anti-TNF therapy, or those who may require either a~     different treatment option, or additional pathway inhibition in addition to TNF, in order to~     achieve clinical response.~   "
72332|NCT02620176|"~     We are evaluating the role of transcutaneous electrical vagal nerve stimulation in the~     prevention of oesophageal pain hypersensitivity using a validated human model in healthy~     volunteers.~   "
72333|NCT02620163|"~     To evaluate efficacy and safety of YH22162 versus telmisartan / amlodipine treatment in~     patients with hypertension inappropriately controlled on telmisartan/amlodipine treatment~   "
72334|NCT02620150|"~     This is a 10 week, double-blind, placebo controlled trial to evaluate SSRI (Selective~     Serotonin Reuptake Inhibitor) effects for treatment of depression in HIV/AIDS with a focus on~     innate immunity and inflammation. Depressed population is HIV + on cART, not currently on~     treatment for depression. Subjects will complete cognitive behavior therapy, CCBT for their~     depression. Blood samples collected for virologic, neuroendocrine, and immunologic~     evaluation. Our overarching hypothesis is that SSRI treatment of depression and improvement~     of depressive symptoms leads to increased innate immunity and decreased inflammation,~     resulting in better control of HIV disease and decreased morbidity.~   "
72335|NCT02620137|"~     A prospective randomized study of patients undergoing a laparoscopic sleeve gastrectomy was~     performed. Patients were randomized into 2 groups: those patients receiving the multivitamin~     supplement during 3 months (Group 1), and those receiving the supplement during 12 months~     (Group 2). Laboratory data were recorded: vitamins and oligoelements at 3, 6 and 12 months~     after surgery.~   "
72336|NCT02620124|"~     Back ground: A single dose of GnRH analogue in the luteal phase is reported to improve the~     outcome of IVF/ICSI treatments but the effect in FET cycles has not been reported.~      Aim: To compare the results of frozen thawed embryo transfers with and without GnRHa analogue~     support Primary end point: IR, PR, on going PR Secondary end point: hCH, E2 and progesterone~     levels 14 days after thawing~   "
72337|NCT02620111|"~     The aim of this study is to investigate potential protein synthesis effects of whey protein~     high in leucine compared to whey protein with normal leucin content in elderly patients in a~     acute crossover setting. We will use the method of a 2 X 3 h tracer infusing protocol with~     15Nphenylalanine along with blood samples and muscle biopsies.~   "
72338|NCT02620098|"~     The purpose of the study was to examine the effectiveness of an occupational therapy led~     handwriting intervention for special education and at-risk kindergarten students.~   "
72339|NCT02620085|"~     Observe the relationship between thyroid function and personality traits~   "
72340|NCT02620072|"~     Type 1 diabetes (T1D) results from an autoimmune destruction of the insulin-producing beta~     cells. The process of autoimmune destruction is identified by circulating islet~     autoantibodies to beta cell antigens, and is mediated by a lack of immunological~     self-tolerance. Self-tolerance is achieved by T cell exposure to antigen in the thymus or~     periphery in a manner that deletes autoreactive effector T cells or induces regulatory T~     cells. Immunological tolerance can be achieved by administration of antigen under appropriate~     conditions. Evidence is now emerging in humans that these approaches may be effective in~     chronic inflammatory diseases such as multiple sclerosis and allergy. Administration of oral~     insulin in multiple islet autoantibody-positive children offers the potential for inducing~     immunological tolerance to beta cells and thereby protect against further development~     progression to type 1 diabetes.~   "
72843|NCT02613494|"~     A randomised placebo-controlled feasibility study of glycopyrrolate and hyoscine in the~     treatment of clozapine-induced hypersalivation to assess recruitment and retention rates in a~     multi-centre trial.~   "
72343|NCT02620033|"~     The researchers hope to learn if yoga complementary therapy would improve health-related~     quality of life, recovery of urinary continence and erectile function in patients who~     underwent prostate cancer surgery (i.e. radical prostatectomy). We hypothesized that in~     patients undergoing radical prostatectomy, preoperative and postoperative Yoga complementary~     therapy would improve health- related quality of life (HRQOL), recovery of urinary continence~     and erectile function.~      This two-arm, randomized controlled pilot study will compare Yoga intervention to usual care~     group. The aim is to evaluate the efficacy of Yoga complementary therapy on HRQOL in patients~     who underwent radical prostatectomy (RP). Yoga therapy will be given to the intervention~     group three times in a week for 6 weeks prior to surgery and then initiated 3 weeks after the~     surgery for another 6 weeks. The yoga exercise will be tailored to the participant's comfort~     level. As an exploratory analysis, we will evaluate pro-inflammatory and immunological~     markers.~   "
72344|NCT02620020|"~     The main objective of the trial is to evaluate the efficacy of fasinumab compared to placebo~     as measured by the change from baseline in the average daily Low Back Pain Intensity (LBPI)~     Numerical Rating Scale (NRS).~      Secondary objectives of the study are to evaluate the efficacy of fasinumab compared to~     placebo as measured by:~        -  Change from baseline in the Roland Morris disability questionnaire (RMDQ) total score~        -  Change from baseline in the Patient Global Assessment (PGA) of Low Back Pain (LBP) score~        -  Change from baseline in the average daily LBPI NRS score~   "
72345|NCT02620007|"~     The primary objective of this trial is to assess whether a 12-week treatment with~     Ciprofloxacin and Rifaximin is superior to placebo to obtain endoscopic remission in~     adherent-invasive E. coli (AIEC)-colonized patients with ileal Crohn disease (CD), with or~     without involvement of the caecum or the right colon.~   "
72346|NCT02619994|"~     The purpose of this study is to compare the efficacy of a 'new treatment regimen including~     delamanid, linezolid, levofloxacin, and pyrazinamide for nine or twelve months~     (investigational arm)' and 'the standard treatment regimen including injectables for 20 to 24~     months (control arm)' for treating quinolone sensitive multidrug-resistant tuberculosis.~   "
72347|NCT02619981|"~     150 children aged between five and seven years presenting for the first dental visit, whose~     parents consented to participate in the study were selected from patients reporting to the~     dental clinics Riyadh Colleges of Dentistry and Pharmacy using convenience sampling. Pulse~     rate for each patient was measured at different clinical situation starting from patient~     parent separation until end of appointment using a pulse oximeter, Data which collected was~     statistically analyzed using appropriate statistical analyses using SPSS ver.19 data~     processing software.~   "
72348|NCT02619968|"~     The aim of this study is to analyze the effectiveness of physical exercise with blood flow~     restriction on the diameter and the flow of vessels, muscle strength and circumference of the~     forearm in patients with CKD prior to making FAV.~   "
72349|NCT02619955|"~     The study explores the hepcidin deficiency causes of rare iron overload (excluding C282Y~     homozygosity), and aim to characterize this iron overload in term of clinical, biological,~     genetic and functional spacificities.~   "
72350|NCT02619942|"~     To investigate whether extended lymphadenectomy (CME) in laparoscopic colectomy could improve~     disease-free survival in patients with right colon cancer, compared with standard D2 radical~     operation.~   "
72351|NCT02619929|"~     The aim of this non-interventional study is to assess oral vinorelbine dose schedules~     (initial dose, dose increase/maintenance/reduction) applied during the initial 8 weeks of~     treatment under routine conditions in Germany together with the underlying reasons for the~     respective chosen schedules.~   "
72352|NCT02619916|"~     The purpose of this study is to determine whether mindfulness-based cognitive therapy (MBCT)~     and cognitive behavioral therapy (CBT) are effective in reducing depressive symptoms in~     patients after cancer~   "
72353|NCT02619903|"~     Chronic obstructive pulmonary disease (COPD) and gastric ulcer both get infected via or from~     the oropharyngeal tissues and have antibiotics in their treatment regimen of both diseases.~     This proposal suggests that the oral microbiome, in particularly dental plaque, is a~     plausible source of reinfection of COPD and gastric ulcer.~      Subjects with COPD or gastric ulcer are randomized to an adjunctive dental cleaning or no~     dental treatment. Both groups undergo the regular treatment for their respective diseases.~     Both groups have a full dental examination and have salivary microbiota as well as dental~     plaque harvested.~      The primary outcome variables is COPD exacerbations and new gastric ulcer event, and the~     secondary outcome variable re-colonization of the stomach and lung.~      Given that the study shows that additional dental cleaning does have an impact on reinfection~     of gastric ulcer and COPD it implies that dental cleaning should be subsidized when treating~     these diseases. This would have a significant impact on restricting antibiotic resistance as~     both H. pylori infections and COPD are treated with antibiotics. Both diseases also cause~     personal suffering and consequently disables the person to work, which causes financial~     consequences, and of course healthcare expenses.~   "
72354|NCT02619890|"~     This registry aims to collect clinical and radiologic information including detailed~     clinical, conventional MR and advanced MR imaging data of patients with brain gliomas.~     Advanced MR imaging may include diffusion-weighted imaging, perfusion-weighted imaging~     (dynamic susceptibility contrast, arterial spin labeling, dynamic contrast enhancement), and~     chemical exchange saturation transfer (CEST) imaging. This registry will describe course of~     disease and long-term outcomes of brain gliomas.~   "
72355|NCT02619877|"~     This is a phase II single-blinded study to evaluate the efficacy and safety of ALLO-ASC-DFU~     in patients with Diabetic Foot Ulcer, compared to standard therapy.~   "
72356|NCT02619864|"~     The standard or usual treatment for this disease is standard chemotherapy alone. For the~     first part of this study (phase I), there are two purposes. The first is to see whether~     AZD2014 can affect glioblastoma multiforme, and the second purpose is to see what effects it~     has.~   "
72357|NCT02619851|"~     This clinical trial is a Phase II controlled, parallel, open-label trial, designed to test~     the efficacy and safety of ALLO-ASC-DFU and conventional therapy in Deep Second-degree burn~     wound subjects.~   "
72358|NCT02619838|"~     The objective of this study is to prospectively evaluate the mid-term results and~     intraoperative and postoperative complication rate in patients who underwent double or triple~     arthrodesis using CCS screws.~   "
72359|NCT02619825|"~     First, investigators must determine the physiological standards across age classes of~     myocardial stiffness estimated by Elastography in ultrafast (estimated right ventricular~     stiffness [VD] and left ventricular [LV]). This will be done in groups of children without~     heart condition, age group (10 children per group, four age groups [0-1mois, 1 month-1 year 1~     year-5 years, 5 years-15years]).~      Secondly, investigators will evaluate myocardial stiffness Elastography (RV and LV) on~     different groups of children (same age group) with cardiomyopathy and examine correlations~     with the conventional parameters of systolic and diastolic function of both ventricles and~     with myocardial strain values. The total population of the study will be 120 children (40~     healthy, 80 patients).~   "
72360|NCT02619812|"~     For patients who receive a hematopoietic cell transplant (HCT), there is a risk of developing~     a diarrhea secondary to the chemotherapy which we give. Diarrhea is usually harmless in~     healthy adults; however, in transplant patients, diarrhea can result in dehydration, negative~     impact on quality of life, and prolonged hospitalization. The purpose of this study was to~     see if Colesevelam (Welchol) and Serum-derived bovine immunoglobulin-protein (SBI) result in~     a change in the frequency or consistency of your bowel movements.~   "
72361|NCT02619799|"~     This study compares whether addition of Magnesium or Midazolam intrathecally to epidurally~     administered isobaric Ropivacaine improves the quality of blockade, haemodynamics and~     duration of analgesia post-operatively. 25 parturients were given intrathecal Magnesium and~     rest of the 25 parturients were given intrathecal Midazolam combined with 0.75% Ropivacaine~     via epidural route.~   "
72362|NCT02619786|"~     The purpose of this study is to determine whether inhaled colistin is effective in the~     treatment of ventilator associated tracheobronchitis due to gram negative organism~     susceptible to colistin.~   "
72363|NCT02619773|"~     Infections at the site of surgical incisions (SSIs) are the most common infection among~     surgical patients. Although all patients undergoing surgical procedures are at risk for~     developing SSIs, colorectal surgery has had consistently had high rates of SSIs, ranging from~     3-45%. These infections can increase the length of hospital stay, and increase the rate of~     readmissions and costs.~      Further research is needed to study the effects of mupirocin in general surgery. A recent~     study compared colorectal SSI rates between mupirocin and standard gauze surgical dressings.~     The results of this show that mupirocin has the greatest effect on reducing SSI rate when~     compared to standard gauze dressings. However, these studies have not been performed in the~     United States and have only been studied on a very specific patient population.~      The purpose of this study is to assess the rate of infections at the surgical incision after~     colorectal surgery when a mupirocin dressing is placed versus a standard gauze dressing~     without mupirocin.~   "
72364|NCT02619760|"~     The purpose of this study is to evaluate the safety of reducing dual antiplatelet therapy~     (DAPT) duration to 1 month after implantation of the everolimus-eluting cobalt-chromium stent~     (CoCr-EES).~   "
72365|NCT02619747|"~     Multi-centre, randomised, open-label, placebo-controlled, two-period crossover study of 4~     hour pH monitoring following a refluxogenic meal and drink.~   "
72366|NCT02619734|"~     The purpose of this study is to evaluate the safety and efficacy of autologous bone marrow~     stem cell implantation for the treatment of leg ulcer in adult patients with sickle cell~     disease.~   "
72367|NCT02619721|"~     Evaluate the long-term clinical effectiveness and safety of the PINS Sacral Neuromodulation~     to patients with refractory Overactive Bladder.~   "
72368|NCT02619708|"~     In the current constantly changing healthcare landscape quality measurement has a central~     role. As the practice of medicine is shifting from authority to accountability, the quality~     of surgical interventions is under continuous scrutiny by patients, peers, payers, and policy~     makers. If done appropriately quality measurement can empower all members of the healthcare~     debate. There is increasing focus on patient satisfaction outcomes as quality indicators.~      An important part of surgical outcomes is a patient's perception of the result of the~     intervention and overall experience in the preoperative setting. When assessing surgical~     outcomes, measuring patient satisfaction is necessary. A qualitative systematic review of~     patient satisfaction measures noted a scarcity of well-development quality improvement~     initiatives to improve patient satisfaction. Anxiety, a potent behavioral and psychological~     reaction, weighs heavily on a patient's perioperative experience and is exacerbated by~     preoperative concerns about underlying disease and impending anesthesia and surgery.~      There are multiple stressors on the day of the surgery: unfamiliar environment, multiple~     forms to be signed, and multiple short encounters with new and unfamiliar personnel. These~     create confusion, increase baseline anxiety, and can negatively affect patient experience,~     and by extension surgical outcomes.~      Increasing familiarity with this environment can help patients feel more informed about what~     matters most to them, and have more accurate expectations of possible benefits and harms of~     their options. This can potentially decrease overall anxiety, improve patient satisfaction,~     and decrease pain levels. With the current study investigators will have the following two~     specific aims:~      Aim 1. To determine whether an immersive preoperative experience (video) is associated with~     decreased anxiety and improved patient experience during the perioperative phase.~      Aim 2. To determine whether an immersive preoperative experience is associated with decreased~     stress, improved patient satisfaction, and decreased pain during the perioperative phase.~   "
72369|NCT02619695|"~     Mechanical low back pain is one most important emergency department presentations of patients~     seeking pain relief. Although parenteral pain killers such as opioids, non-steroidal~     anti-inflamatuar drugs and paracetamol are used commonly in these patients, application of~     analgesics in gel forms might be an reasonable alternative to these drugs with fewer adverse~     effects.~   "
72370|NCT02619682|"~     This phase II trial studies the safety of alternating ixazomib citrate and lenalidomide as~     treatment to help keep cancer from coming back after stem cell transplant (maintenance~     therapy) in treating patients with multiple myeloma. Ixazomib citrate may stop the growth of~     cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may~     stimulate the immune system to attack cancer cells. Giving ixazomib citrate and lenalidomide~     as maintenance therapy after transplant may prolong the length of time until the cancer~     returns.~   "
72382|NCT02619526|"~     Heart failure (HF) is a common and disabling condition in the elderly. Randomized clinical~     trials and meta-analyses have clearly demonstrated that long-term use of β blockers improves~     the outcomes of patients with HF. However, limited data have been available on the treatment~     of HF with preserved ejection fraction (EF) in the elderly. No study has specifically~     compared the relative effectiveness of carvedilol and nebivolol in treating HF in old age~     patients with preserved EF.~   "
72383|NCT02619513|"~     The purpose of this study is to explore the effectiveness of dexmedetomidine as an adjunctive~     analgesic, used in ultrasound-guided continuous thoracic paravertebral blocks for~     Post-thoracotomy Pain Syndrome(PTPS).~   "
72844|NCT02613481|"~     This study will evaluates the emotional and functional benefits of Poly-L-Lactic Acid~     (Sculptra™), a cosmetic product used to fill defects of the skin. All participants will~     receive Sculptra™.~   "
72371|NCT02619669|"~     Millennium has developed TAK-228, which is a novel, highly selective, orally bioavailable~     adenosine 5' triphosphate (ATP)-competitive inhibitor of the serine/threonine kinase referred~     to as the mechanistic target of rapamycin (mTOR). TAK-228 (formerly INK128 or MLN0128)~     targets 2 distinct multiprotein complexes, mTORC1 and mTORC2. TAK-228 selectively and~     potently inhibits mTOR kinase (IC50 = 1.1 nM), inhibits mTORC1/2 signaling, and prevents~     cellular proliferation.~      The mTOR complex (mTORC) is an important therapeutic target that is generally stable (i.e.,~     low tendency to mutate) and is a key intracellular point of convergence for a number of~     cellular signaling pathways. Inhibiting mTOR may inhibit abnormal cell proliferation, tumor~     angiogenesis, and abnormal cellular metabolism, thus providing the rationale for mTOR~     inhibitors as potential agents in the treatment of a number of indications including solid~     tumor and hematological malignancies, as either monotherapy or in combination with other~     chemotherapeutic agents. Like rapamycin, several newly approved rapalogs (temsirolimus and~     everolimus) are specific and allosteric inhibitors of mTORC1, and only partially inhibit~     mTORC1 signaling pathways. They do not directly inhibit mTORC2, which has shown to be an~     emerging target in cancer research. TAK-228 was developed to address the incomplete~     inhibition of the mTOR pathway by rapalogs.~      Eligible subjects will have a research biopsy and baseline blood and urine studies done~     within two weeks prior to start of study treatment. Subjects will then be treated with~     TAK-228 for 10 days, and a repeat biopsy and pharmacokinetics will be done on day 11.~      The subject will then be treated with the combination of TAK-228 and letrozole for an~     additional 110 days, before undergoing resection of the primary tumor. Subjects will be~     treated at the recommended Phase II dose of TAK-228 of 3 mg once daily, and a dose~     deescalation to 2 mg daily will be performed if dose-limiting toxicity is seen in 1/3 or more~     of the subjects at the first dose level. The maximum tolerated dose cohort will be expanded~     to include six to ten subjects.~   "
72372|NCT02619656|"~     The investigators hypothesize that using carbon dioxide for PEG placement versus using room~     air will decrease post-procedure pneumoperitoneum as well as improve post-procedure~     bloating/pain, and waist circumference.~   "
72373|NCT02619643|"~     Following brain injury (e.g. stroke), application of non-invasive brain stimulation may~     improve rehabilitative efforts. However, the most effective method of non-invasive brain~     stimulation is unknown. Paired associative stimulation (PAS) is a method of non-invasive~     brain stimulation that pairs an electrical peripheral nerve stimulus with a magnetic stimulus~     to the head. This method can be applied in a manner that increases (facilitates) or decreases~     (depresses) excitability within the brain. Furthermore, applying two consecutive PAS sessions~     within minutes of each other (called primed PAS) may augment changes in excitability more~     than a single PAS session alone.~      Thus, the purpose of this study is to compare the effect of a double PAS session (primed PAS)~     to the effect of a single PAS session (unprimed PAS) and a sham PAS session in healthy~     individuals.~   "
72374|NCT02619630|"~     The purpose of this study is to evaluate the efficacy of nelarabine-based consolidation and~     maintenance therapy in term of relapse-free survival (RFS) in high-risk (HR) patients.~   "
72375|NCT02619617|"~     The purpose of this study to determine if SOM230 is safe and effective for the treament of~     cluster headache.~   "
72376|NCT02619604|"~     This project addresses the need to improve physician knowledge and clinical practice patterns~     related to quality of life (QoL) concerns for patients with chronic lymphocytic leukemia~     (CLL).~   "
72377|NCT02619591|"~     Patients with chest trauma undergo ultrasound to detect a collapsed lung. Two techniques have~     been described. A single view for each hemi-thorax, and multiple views for each hemithorax.~     The investigators are comparing these two techniques in a randomized prospective trial.~   "
72378|NCT02619578|"~     During the past four decades, gynecologic laparoscopy has evolved from a limited method to an~     advanced operative approach that frequently serves as a substitute for laparotomy. The~     advantages of laparoscopy over laparotomy include less postoperative pain, shorter hospital~     stays, and reduced blood loss. However, in the surgery CO2 increases the intra-abdominal and~     intrathoracic pressure, which leads to cardiac output decrease and increases sympathetic~     activity in a reflex. On the other hand, CO2 accumulation in the body leads to hypercapnia,~     which indirectly stimulates aortic body chemosensory organs and carotid sinus, increasing the~     concentration of plasma catecholamines, cortisol and vasopressin , these responses have an~     important impact on patient recovery after surgery.~      Acupuncture is an ancient Chinese method to treat diseases and relieve pain. Transcutaneous~     electrical acupoint stimulation (TEAS), a noninvasive adjunctive intervention based on~     acupuncture, has been widely accepted and used worldwide. To date, multiple studies have~     demonstrated TEAS could reduce intra-operative opioid drugs consumption, reduce the incidence~     of postoperative nausea and vomiting (PONV) and improve postoperative cognitive function.~     However, whether TEAS could improve the quality of early recovery after gynecologic~     laparoscopy is unknown. In this study we therefore investigated the effects of TEAS at the~     acupoints of Baihui (GV20), Yingtang (EX-HN3), Zusanli (ST36) and Neiguan (PC6) on the~     quality of early recovery in the patients undergoing gynecological laparoscopic surgery.~   "
72379|NCT02619565|"~     This study aims at prospectively enrolling a cohort of 400 incident cases of myelodysplastic~     syndromes (MDS) at diagnosis, to evaluate the impact of recurrent mutations on overall~     survival and event-free survival, using next generation sequencing. Patients are affected by~     ineffective hematopoiesis and a propensity to leukemia in the elderly with a global incidence~     of 10/100,000/year.~   "
72380|NCT02619552|"~     Crohn's disease is a chronic inflammatory condition of the intestines that causes abdominal~     pain, diarrhea, tunnels around the anus (fistulas), and extraintestinal symptoms. Effective~     medical treatments exist to treat the disease; however they can have significant side~     effects.~      Previous studies have shown that sexual function is impaired in patients with Crohn's~     disease. It is likely that both the symptoms related to the disease, medications used to~     treat the disease, and surgery all impair sexual function in a variety of ways. For example,~     body image may be impaired, patients may be worried about bowel incontinence or unpleasant~     odors associated with diarrhea, patients may have significant pelvic pain secondary to~     perianal fistulas, or they may have painful intercourse from adjacent inflammation or~     scarring in the pelvis. The impact of medical treatment on patient's ability to regain sexual~     function is not known.~      The investigators propose a 6 month study to compare sexual function before and after~     treatment in patients with Crohn's disease about to initiate therapy with an anti-TNF drug~     for treatment of perianal fistula or intestinal Crohn's or about to initiate therapy with~     steroids.~      The investigators anticipate that the investigators will show that therapy with an anti TNF~     agent will result in a more rapid and greater return of sexual function than steroids. This~     information will be important to help counsel patients about the optimal treatment to begin~     for treatment of their Crohn's disease. Furthermore, it would be the first study to evaluate~     the impact of medical therapy on sexual function.~   "
72381|NCT02619539|"~     Shock-index is potentially an easy tool to estimate the risk of hypofibrinogenemia without~     the need to perform other potentially time consuming investigations.~   "
72385|NCT02619487|"~     The purpose of this study is to determine whether a simple text message reminder sent to the~     parent of an child/adolescent with Type 1 Diabetes(or parent and adolescent) is effective in~     helping the individual(or parent) become more compliant with self-managing the Type 1~     Diabetes (T1D). There will be 5 arms: text message sent to parents of children age 8-12 years~     old with T1D, text messages sent to parents of adolescents ,age 13-18 years old, with~     T1D,text messages sent to parents of adolescents with T1D as well as the adolescent with~     T1D,no text message sent to parents of children age 8-12 years, and no text message sent to~     adolescents or parents of adolescents age 13-18 years old.~   "
72386|NCT02619474|"~     These days, particularly over the last decade, attention is being paid to the opinion of the~     patient and, in the case of pediatrics, the patient's family. Unfortunately, recent work has~     shown that this remains an imperfect process. Studies of inpatient families show that parents~     often leave hospital with only a minimal idea of side effects of drugs, who they can contact~     in the event that something goes wrong, and even something as simple as the date of the next~     medical visit. In fact, some studies have shown that adult patients don't even know the name~     of their doctor or nurse.~      While there are several papers examining the degree of unhappiness of parents in hospitals,~     there is very little research looking at what can be done to improve a patient's sense of~     satisfaction with care (and communication) while in the hospital. One suggestion has been the~     provision of whiteboards in the room that can allow the family to have a better idea of what~     is going on during the child's day. These have been suggested but never exposed to~     prospective, quantitative study.~      With the intention of improving the management of patients in the new Acute Care Centre, the~     department of strategic planning at Children's Hospital organized a three day IMPROVE session~     moderated by PHSA specialists in quality control. During this meeting, the clinical course of~     a child on the medical and surgical wards was mapped out. This allowed the group to examine~     various ideas aimed at improving the care of children passing through the hospital and the~     sense of parental satisfaction with the whole process.~      The main conclusion from the meeting (based both on available literature and the clinical~     experience of the group), was that communication between the medical team and parents should~     be improved. It was also concluded that the best way to do this would be to have a regularly~     updated whiteboard in each room. Prior to starting this, it was generally felt that the~     introduction of whiteboards should be tested in a prospective controlled manner - starting~     with a baseline study of patient satisfaction.~   "
72387|NCT02619461|"~     This study describes the effect of acute high intensity exercise at 70% VO2peak on~     inflammation, stress, appetite hormones and appetite in lean and obese children and~     adolescents.~   "
72388|NCT02619448|"~     The standard treatment for patients with Non-Small Cell Lung Cancer (NSCLC) and clinically~     negative lymph nodes remains surgery per current guidelines. Five year survival for patients~     with stage I non-small cell lung cancer is generally greater than 50% after surgery. Many of~     these patients have heart and lung issues or other diseases which keep them from undergoing~     curative surgery. Studies have shown that majority of these patients die from their cancer~     and not from their other diseases. This is the reason for treating early stage lung cancer~     patients with definitive therapy, when they cannot have surgery. This study will enroll~     twelve subjects to evaluate the side effects of this treatment, and decide if it is a good~     option for the patients that cannot have surgery.~   "
72389|NCT02619435|"~     The purpose of this study is to purpose of this study is to assess if regorafenib is active~     enough, in terms of 6-month progression-free rate, to warrant further comparative studies in~     patients with RAS-mutant advanced colorectal cancer who have progressed after first-line~     oxaliplatin-based chemotherapy plus bevacizumab.~   "
72390|NCT02619422|"~     To determine if an intensive cardiac rehabilitation program with periodic reinforcements~     improve the compliance/adherence to secondary preventive measures (physical exercise,~     mediterranean diet, tobacco abstinence, pharmacological treatment) after an acute coronary~     syndrome with or without ST segment elevation versus an standard cardiac rehabilitation~     program~   "
72391|NCT02619409|"~     Bupivacaine spinal is commonly performed as the primary anesthetic for orthopedic procedures.~     In some cases the duration of the block is inadequate. An epinephrine wash is sometimes~     performed to prolong the duration of the block. The epinephrine wash may prolong the duration~     of the block, and if it does, to what extent?~   "
72392|NCT02619396|"~     Atrial fibrillation (AF) is a very common abnormal heart rhythm, triggered by rapid~     electrical activity originating from the pulmonary veins (PVs) that drain blood from the~     lungs back to the left atrium (LA). Ablation of the junction between the PVs and the LA,~     electrically isolating the veins from the heart, is the key to prevent AF.~      When using radiofrequency energy (RF), transmural lesions are required to achieve permanent~     pulmonary vein isolation (PVI). New technologies are currently available to predict the~     ablation lesion depth and to guide the duration of each application. However, deeper lesions~     mean a higher risk of overheating and damage of adjacent structures such as the esophagus~     that lies against the back wall of the LA. In order to minimize this risk, the investigators~     continuously monitor the temperature inside the esophagus during the procedure through a~     probe placed in the esophagus and they promptly terminate energy delivery in case of any~     esophageal temperature rises more than 39°C.~      To date, it is not known if a low power for a longer time is better than a high power for a~     shorter time when ablating on the LA posterior wall in order to create permanent scars~     without heating the esophagus.~      Therefore, the investigators plan to compare the incidence of esophageal temperature alerts~     and the success of the procedure with four different energy settings during ablation on the~     LA posterior wall.~   "
72393|NCT02619383|"~     Recent studies have shown that hyperbaric oxygen therapy (HBOT) can induce angiogenesis and~     improve impaired organ function. HBOT was also recently suggested as a possible therapy for~     ED due to surgical injuries. However, the effect of HBOT on non-surgical related ED has not~     been investigated to date.~      The objective in this study was to assess the effect of HBOT on patients with ED by means of~     sexual function questionnaires and novel imaging techniques.~   "
72394|NCT02619370|"~     The overarching goal of this project is to facilitate engagement of individuals in effective~     advance care planning (ACP). Our specific objective is to conduct a randomized, controlled~     trial to determine whether playing a structured conversation game will increase the~     likelihood that participants will complete advance directives and perform other ACP behaviors~     compared to those who are provided with only standard ACP educational materials.~   "
72408|NCT02619188|"~     This study evaluate the rate of nausea and nutritional status in patients with hyperemesis~     gravidarum (severe nausea and vomiting in pregnancy) and healthy pregnant women using a~     questionnaire (PUQE-score), self-reported food/drink intake form and blood test. The~     Investigators aim for developing normal range of prealbumin measurements (reference values)~     during first trimester of pregnancy.~   "
72845|NCT02613468|"~     The objective of this study was the evaluation of periodontal condition in pregnant women and~     the effect of the treatment of periodontal disease upon low birth weight.~   "
72395|NCT02619357|"~     The prevalence, low cost, and low burden of wearable devices that provide quantitative and~     qualitative feedback on a subject's activity level present an opportunity for the use of~     these devices in clinical and observational studies. However, the accuracy and~     reproducibility of any given device may vary with device design and algorithm implementation.~     Therefore, validation of emerging technologies against known standards such as analysis of~     exhaled breath and currently available medical devices is critical. This is a single center,~     two-cohort, single period, open-label, methodology study. No investigational product will be~     used in this study. Eligible subjects will wear 2 generations of SenseWear Armband devices, 2~     ActiGraph GT9x devices (one on the wrist and one on the waist) and a Garmin Vivofit 2~     activity tracker wristband for up to 24 hours per day. Subjects who consent to participate in~     an optional sub-study will wear a SOMNOwatch Plus EEG-6 device while sleeping. Subjects will~     perform a variety of laboratory and field-based exercise tests and strength exercises using~     Latex-Free Therabands.The co-primary objectives of this study are firstly to compare the~     outputs of the test devices (SenseWear Armband Gecko and Actigraph GT9x) to those of the~     SenseWear Armband MF and secondly to assess the sensitivity and accuracy of the test devices~     in subjects with COPD or asthma while performing laboratory-based exercise testing.~   "
72396|NCT02619344|"~     The overall hypotheses of this project is that severe sepsis is associated with endothelial~     dysfunction in pediatric patients and that selenium deficiency is associated with changes in~     biological markers of endothelial dysfunction and that these changes, in turn, are associated~     with worse clinical prognosis.~   "
72397|NCT02619331|"~     Skin prick tests (SPT) are commonly used in daily allergological practice to assess skin~     reactivity to allergens. Multiple factors can contribute to non-optimal results of~     conventional wheal and flare measurement (CWFM) of SPT such as inaccurate measurements,~     observer-dependency and absence of traceability.~      This study aims to evaluate the quantification of SPT by a novel High Speed Laser Doppler~     Imaging (HSL-DI) and to compare it with CWFM. First, SPT with birch and/or grass pollen~     extracts as well as positive and negative controls will be performed in 20 volunteers (11~     atopics, 9 non-atopics) to establish the characteristics (cut-off, optimal reading time and~     allergen concentration) of HSL-DI analysis based on two parameters (area and flow~     measurement). In a second step, fifty patients will be tested with birch and grass pollen~     extracts at optimal allergen concentration and time window. Analysis of SPT by HSL-DI and~     CWFM will be compared.~   "
72398|NCT02619318|"~     This is a RCT study, aiming at evaluating the effectiveness of the Everyday Life in Balance~     (BEL) intervention.~      The intervention: The BEL was developed on the basis of previous research on lifestyle~     interventions made by the current research group and other researchers . It is a group-based~     programme (5-8 participants) with 12 sessions, one session a week, and 2 booster sessions~     with two-week intervals. The themes for the group sessions are, e.g., activity balance,~     healthy living, work-related activities, and social activities. Each session contains a main~     group activity and a home assignment to be completed between sessions. The main group~     activity starts with analysing the present situation and proceeds with identifying desired~     goals and finding strategies for how to reach them. The home assignment is aimed at testing~     one of the proposed strategies. Self-analysis, setting goals, finding strategies and~     evaluating the outcome of tested strategies form a process for each session, but also for the~     BEL intervention as a whole. After completed BEL, the participants will have developed an~     ability to reflect on their own situation and have strategies for changing their everyday~     life in a desired direction, such that they feel their everyday life has a satisfactory~     balance between rest and work, secluded and social activities, etc.~      The BEL intervention is led by occupational therapists. They take part in a specifically~     developed two-day education and follow the BEL manual [7]. They also participate in a~     web-based discussion forum where they can seek support from the researchers and/ or other BEL~     occupational therapists.~      Selection of units and participants: On the basis of blocks of four units, two are randomized~     to the BEL and two to the control condition, which is care as usual (CAU) and generally means~     standard occupational therapy. Occupational therapists in the units select participants based~     on the patients' needs for a lifestyle intervention and being likely to benefit from a group~     intervention. The same criteria are applied in the BEL units and the CAU units.~      Power analysis: The investigators desire 120 participants from each group. This will also~     allow for analysis of subgroups.~      Instruments: A number of self-report instruments tapping satisfaction with daily occupations,~     well-being, perceived worker role, social interaction, recovery etc., will be used,~     supplemented with qualitative interviews.~      Procedure: As the intervention starts, the attendees answer questionnaires about their~     personal situation regarding. Subsequently, the BEL is implemented in the units randomised to~     that condition. After 16 weeks of intervention (including the booster sessions), the~     measurements are repeated. A follow-up is then made after another six months. The same data~     collection is made at corresponding time points in the comparison units.~      Additional qualitative interviews are made in the intervention units, with strategically~     selected participants (attendees and staff) to get a deeper picture of the intervention~     process and its implications.~      When the research project is finished, the comparison units will be given the opportunity to~     go through the intervention.~      Analyses: The primary analysis concerns differences in outcomes between the BEL group and the~     CAU group. Analyses of the qualitative interviews, by means of grounded theory, will yield a~     more detailed description of the BEL and its implications, as perceived by both attendees and~     staff.~      Current state of the study: The project is in the initial phase and the first units were~     recruited in late 2012. At present, 24 units have been randomized to either condition. The~     second measurements (after completed BEL) have just been completed and follow-ups will~     continue until mid-2016, as will qualitative interviews. Analysing data and reporting results~     will continue until late 2018.~      By including 60 participants in each group the studies will be able to detect a medium effect~     size (ES=0.4), which would be a difference of clinical and practical significance.~      Age, gender and being of foreign origin will be considered as covariates, along with other~     socioeconomic factors such as family situation, educational level and money at one's~     disposal. Other factors that should be considered are the participant's functional status and~     diagnoses. Research has not shown that diagnosis per se plays any substantial role in the~     outcome of psychiatric rehabilitation, for the course of a psychiatric disability or for how~     people perceive their everyday occupations, but this should be investigated further because~     the evidence is inconclusive. Level of functioning, level of psychopathology, and negative~     symptoms have indeed been shown to be of importance for outcomes of psychiatric~     rehabilitation. Therefore, this project will also control for factors related to diagnosis~     and functional status.~   "
72399|NCT02619305|"~     The objective of our study is to determine whether a livelihood intervention can change~     economic and psychosocial outcomes of social network ties and geographically proximate~     neighbors of impoverished women in rural Uganda.~   "
72400|NCT02619292|"~     The purpose of this study is to determine if participating in a Mindful Movement Program~     (MMP) (learning how to be mindful in one's movement), positively affects the body's immune~     functions improves mindfulness and reduces worries about cancer returning. All participants~     will be in this study about three months.~   "
72401|NCT02619279|"~     The objective of the study is to determine whether a livelihood intervention can improve~     health and schooling outcomes of the children of woman participating in a livelihood~     intervention in rural Uganda.~   "
72402|NCT02619266|"~     This trail will be carried out to evaluated the effect and safety of acupuncture for the~     anorexia in patients with gastrointestinal tract and lung cancers.~   "
72403|NCT02619253|"~     Primary objective: To assess the safety and tolerability of pembrolizumab in combination with~     vorinostat in patients with advanced renal or urothelial cell carcinoma in order to select~     the recommended Phase 2 dose (RP2D).~      Secondary objectives: (1) To evaluate the overall safety profile of pembrolizumab in~     combination with vorinostat; (2) To assess the anti-tumor activity (i.e. objective response~     rate, progression-free survival) of pembrolizumab in combination with vorinostat in patients~     with advanced renal or urothelial cell carcinoma; (3) To characterize PD-L1/2, immune cell~     subsets, and miRs in tumor and/or blood.~   "
72404|NCT02619240|"~     This is a case control observational study using Bronchial-alveolar lavage (BAL) as specimen~     for GeneXpert, a real time polymerase chain reaction (PCR) test for detection of tuberculosis~     (TB). Patients suspicious of TB, who require bronchoscopy as part of the investigation~     procedures, will be recruited for this study over a period of 18 months. Clinical likelihood~     of TB will be systematically scored according to various clinical parameters. This will~     determine the pre-test probability. Clinician will decide if anti-TB treatment is to be~     started and patients will be followed up for a minimal of 18 months. Sensitivity,~     specificity, positive, negative predictive values and the respective likelihood ratio will be~     calculated accordingly.~   "
72405|NCT02619227|"~     The objective of the study is to determine whether a livelihood intervention can improve~     economic and psychosocial wellbeing in rural Uganda.~   "
72406|NCT02619214|"~     Clinical trial controlled randomized of parallels groups. The study is designed to look for~     differences in the oxidative stress level among healthy patients receiving 2 different oxygen~     concentrations: 30% and 60% during general anesthesia. Once the patient has been informed,~     the affirmative agreement has been obtained and inclusion and exclusion criteria verified the~     patients are randomized to 30% or 60% oxygen concentration. In the operating room while~     placing the intravenous line, a sample blood is obtained. General anesthesia is induced and~     maintained with sevoflurane. After Anesthesia induction the anesthesia machine is fixed in~     order to provide the oxygen concentration according to the randomization. One hour later a~     second venous sample is obtained. Samples are stored in cold conditions until their analysis~     in the laboratories of the biology faculty - Barcelona University.~   "
72407|NCT02619201|"~     Acute gastroenteritis (GEA) is a public health problem at present, the main cause of vomiting~     and consultation in emergencies in children under 5 years. Worldwide, there are about 2~     million deaths per year due to gastroenteritis in children under 5 years.~      In Mexico, the mortality rate by age in 2013, recorded 28 deaths per 100,000 boys and girls,~     in 2013 in our country 2.5 million children between 5 and 17 years engaged in an economic~     activity. The occupancy rate for the child population was 8.6: 11.4 for boys and 5.8 for~     girls.~      NICE guidance gastroenteritis defined as a transient disorder caused by an enteric infection~     and characterized by a sudden onset of diarrhea with or without vomiting~   "
72409|NCT02619175|"~     aims:~        1. To characterize compensatory balance reactions to platform translations during standing~          and walking in poststroke individuals in comparison to healthy individuals.~        2. To explore the effect of lesion characteristics (location, size) on the patients'~          balance reactions.~        3. To explore the impact of clinical measures of unilateral sensory motor impairments,~          balance, gait and fear of falling on postural reactions in stroke subjects.~        4. To examine the effect of a perturbation-based balance training on balance reaction~          characteristics in post stroke individuals.~   "
72410|NCT02619162|"~     Open, multicenter phase I with gradual increase in dosage to evaluate the safety and~     tolerability of orally administered nintedanib plus letrozole orally (2.5 mg / day) for~     patients with breast cancer. Nintedanib is administered twice a day orally for 28 consecutive~     days (Days 1-28) in 4-week cycles.~   "
72411|NCT02619149|"~     The benefit from antibiotic prophylaxis in patients undergoing laparoscopic cholecystectomy~     for acute cholecystitis is insufficiently known. The aim of the present double-blind~     randomized controlled is to compare piperacilin with placebo in patients undergoing~     cholecystectomy for acute cholecystitis with anamnesis not exceeding 5 days. Altogether 100~     patients are intended to be included. Primary endpoint is biliary contamination. Secondary~     endpoints are postoperative hospital stay, health-related quality of life, pain perception,~     postoperative markers of inflammatory response, surgical site infections, infectious~     complications other than surgical site infections, health economy and relationship between~     symptom anamnesis and bile contamination.~   "
72412|NCT02619136|"~     MINT: A pilot, multi-centre, open-label randomized controlled trial of two commonly used~     transfusion strategies in patients with myocardial infarction.~   "
72413|NCT02619123|"~     The Tailored Breast Screening Trial (TBST) is a population-based, non-inferiority randomised~     trial aimed at evaluating the impact of tailored screening strategies addressed to~     premenopausal women, by using breast density as indicator of risk.~      44-45 years old women will be enrolled and invited to undergo a digital mammography. Women~     are then randomly allocated in two arms. In the intervention arm, women will receive a~     tailored screening strategy according to breast density.~      The aim of this study is to assess the impact of a longer screening interval and the~     reduction of side effects for premenopausal women.~   "
72414|NCT02619110|"~     The purpose of this research was to discuss the effect of backward walking treadmill training~     on balance ability, speed of walking and cardiopulmonary fitness in patients with chronic~     stroke.~   "
72415|NCT02619097|"~     The primary objectives of the trial are to assess the safety and pharmacokinetics profile of~     pegolsihematide for treatment of anemia patient with myelodysplastic syndromes.~   "
72416|NCT02619084|"~     The main objective of this project is to evaluate the efficacy of subthalamic nucleus deep~     brain stimulation (STN DBS) in treating motor and phonic tics in medically refractory~     Tourette's syndrome (TS).~      Secondary objectives are to individuate and standardize the best electrical parameters for~     STN stimulation in TS, to evaluate the efficacy and safety on non-motor TS features, such as~     behavioral abnormalities and psychiatric disorders, during chronic STN stimulation, to~     correlate the improvement of TS motor and non-motor symptoms to the modification in brain~     activity recorded by PET study and to explore the pathophysiology of TS, and to evaluate the~     safety of STN DBS in TS patients.~   "
72417|NCT02619071|"~     Adult acute myeloid leukemia (AML) is a heterogeneous hematologic malignancy associated with~     poor prognosis, especially after relapse. High-throughput genomic studies have highlighted~     the importance of molecular alteration in the pathophysiology, clinical evolution and~     treatment response of AML. In addition, identification of specific gene mutation can be~     targeted by specific inhibitors, opening the way to personalized treatments. However, only a~     limited number of gene mutations are druggable or actionable, highlighting the need for~     additional information to guide treatment choices. Among them, new Drug Screening Tests (DST)~     allow for the screening of library of hundreds of drugs to ex-vivo patient-derived AML cells.~     Combination of genomic and pharmacologic approaches might therefore improve prediction of~     drug effects. There is an urgent need to bring these approaches into the clinic but~     feasibility trials are necessary before incorporating them into treatments strategies.The~     proposed study is a prospective multicentre feasibility study of a combined chemo-genomic~     approach in patients with advanced AML.~   "
72418|NCT02619058|"~     Considerable progress in the treatment of metastatic melanoma has been made in the past~     5years, with the approval of immune checkpoint-blocking antibodies and agents targeting BRAF~     mutation. Investigators conducted a open label, dose escalation, phase I clinical trial of to~     explore the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of intravenous~     administration of autologous NKT Cells in metastatic melanoma patients.~   "
72419|NCT02619045|"~     This study evaluate the Impact of a Follow-up Phone Call Nurse Device in the Care of Patients~     With Chemotherapy Treatment, in their Quality of Life and Medico-economic Analysis of this~     Follow-up Program Device.~   "
72420|NCT02619032|"~     This study was a prospective comparative study. The purpose of this study was to investigate~     the hypothesis whether remifentanil compared to fentanyl can induce less inflammatory and~     stress response to the day-case dental surgery in Persons with special needs (PSN). Secondary~     aims were to investigate comparatively their effect on patients intraoperative hemodynamic~     response and postoperative analgesia.~   "
72421|NCT02619019|"~     Dexamethasone, a high-potency, long-acting glucocorticoid, when added to bupivacaine, it~     extended the duration of analgesia. We aim to study the effectiveness of spinal dexamethasone~     in Transuretheral prostatectomy.~   "
72435|NCT02618837|"~     To evaluate the impact on outcomes of the currently accepted antithrombotic strategies based~     on the administration of newer P2Y12 receptor blockers (prasugrel and ticagrelor) in a~     population of non ST elevated ACS (NSTEACS) patients with an initial invasive indication.~      Furthermore, to evaluate the effects of bivalirudin administration in comparison to standard~     therapy with unfractioned heparin (plus provisional anti-GPIIbIIIa) in NSTEACSpatients who~     undergo PCI and will thus receive these potent antiplatelet agents which may theoretically~     favor the occurrence of bleedings.~      A combined measure of efficacy and safety endpoints, the so-called net clinical benefit~     (NACE), will be considered at early (30 days) and mid term (12 months) follow-up.~   "
72422|NCT02619006|"~     When immediate clamping of the umbilical cord (ICC) occurs at birth, 20 to 30% of the~     fetal-placental blood volume is left behind in the placenta. Preliminary results from our~     current study comparing effects of ICC versus placental transfusion from delayed cord~     clamping (DCC) show that infants who have DCC have higher ferritin levels at 4 months of age~     and more myelin in important regions of the brain. Our objective for this follow-up study is~     to see if the effects of placental transfusion persist to three and four years of age. The~     investigators plan to enroll only children who participated in the previous trial (Infant~     Brain Study/NCT01620008) at birth for assessments at three and four years of age. Assessments~     include MRIs and neurodevelopmental testing to examine cognitive, motor, visual, and~     behavioral outcomes.~      The proposed research addresses two central questions regarding the potential benefits of DCC~     on brain myelin development in children who were born healthy at term: 1. Does DCC result in~     increased brain myelin deposition at three and four years of age? and 2) Are DCC, iron~     stores, and brain myelin content in infancy associated with improved cognitive, motor, and~     socio-behavioral outcomes at three and four years of age?~   "
72423|NCT02618993|"~     The sensory innervation of the face depends on the trigeminal (fifth cranial) which is~     divided into three branches, the mandibular nerve (V3) having motor fibers to the temporal~     and masseter muscle. The regional anesthesia of the face has grown in recent years for~     performing certain actions under light general anesthesia or sedation. The mandibular block~     is a simple and reliable technique but little used. Yet it reduces postoperative pain~     sagittal osteotomy of the mandibular branch by reducing consumption of opioids and in the~     oropharynx cancer surgery. Made with ropivacaine, known for its vasoconstrictive action, it~     also improves the visibility of the operative field during mandibular osteotomies reducing~     bleeding. Despite a real clinical benefit (ease of implementation, latency and duration of~     action of the local anesthetic), the V3 block ropivacaine is not evaluated in the~     maxillofacial surgery.~   "
72424|NCT02618980|"~     The primary aim of this study is to compare efficacy of early endoscopy and non-endoscopic~     treatment for management of acute upper gastrointestinal (UGI) bleeding in patients with~     recent acute coronary syndrome (ACS). This study will also compare rates of surgery, repeated~     intervention (endoscopy or TAE), rebleeding and complications between two groups.~   "
72425|NCT02618967|"~     The purpose of this study is to obtain initial information on the safety and tolerability~     (effects good or bad), pharmacokinetics (what the body does to the drug), and~     pharmacodynamics (what the drug does to the body) of a single dose of AMG 570.~   "
72426|NCT02618954|"~     The objective of this study is to determine the longitudinal relation between clinical~     remission and ultrasound (US) remission in Rheumatoid arthritis (RA).~      At a patient level, US-detected residual synovitis (evaluated both by US grey-scale signals~     and power Doppler signals) is frequent in patients with RA in clinical remission. Several~     longitudinal studies reveal an association of US-detected residual synovitis and risk of~     relapse and radiographic progression, in individual patients and joints, over 1-2 years.~      However, the longitudinal relation between clinical remission and US remission is not so~     well-known and it is possible that clinical remission arrive before ultrasound remission.~     Thus arise the question as to whether the presence of US-detected residual synovitis require~     to adapt the treatment to ultrasound findings or to simply increase the patient care.~      The investigator propose to conduct a prospective, bi-center, non randomized study.~   "
72427|NCT02618941|"~     This is a follow-up study to assess safety and clinical activity of continued AFFITOPE® PD01A~     vaccinations in patients with Parkinson's disease. Patients, who have already participated in~     the AFF008 program will be involved and will receive a second boost immunization with~     AFFITOPE® PD01A. One study site in Vienna (Austria) will be involved.~      In addition, up to 6 patients will be offered participation within an untreated control~     Group.~   "
72428|NCT02618928|"~     This study seeks to determine the effectiveness of the interferon-free ABBVIE REGIMEN ±~     ribavirin (RBV) in participants with chronic hepatitis C (CHC) virus in clinical practices~     across France.~   "
72429|NCT02618915|"~     A Phase 1/2, open-label, dose-finding safety study of single ascending doses of DTX101 in~     adult males with moderate/severe to severe hemophilia B.~   "
72430|NCT02618902|"~     A first-in-human clinical trial to treat patients with multiple sclerosis by vaccination with~     tolerogenic dendritic cells (tolDC), generated using Good Manufacturing Practice (GMP) will~     be conducted. In doing so, the feasibility and safety of administering myelin-derived~     peptide-pulsed tolDC in patients with MS will be assessed.~   "
72431|NCT02618889|"~     The purpose of this research study is to evaluate if patients with psychogenic dystonia~     treated with onabotulinumtoxinA (BOTOX) injections will demonstrate lower severity and~     disability at one month and at three months than those having received placebo injections~   "
72432|NCT02618876|"~     Nalbuphine as an adjuvant to bupivacaine caudal anesthesia for postoperative analgesia in~     children undergoing inguinal hernia repair.~      2 groups, 30 patients each~   "
72433|NCT02618863|"~     the investigators have observed that women may require less CF than men to occlude the~     esophageal entrance, and that the routine use of 30 N in women may actually increase the~     incidence of airway-related problems. The objective of the current investigation was to test~     this hypothesis. In this study, real-time visual and dynamic means were used to assess the~     effectiveness of different forces applied to the cricoid cartilage in occluding the~     esophageal entrance in men and women. The patency of the esophageal entrance was directly~     visualized using the Glidescope Video Laryngoscope in anesthetized and paralyzed patients~     with and without CP. Evidence of closure of the esophageal lumen was confirmed by the~     inability to introduce a gastric tube (GT) into the esophagus under direct vision. New method~     , using Cricometer , was used to measure the applied force .~   "
72434|NCT02618850|"~     The purpose of this study is to test whether an early metabolic response, measured by PET/CT~     scan after the first cycle of chemotherapy, is able to predict which patients with advanced~     CRC have a better prognosis.~   "
72446|NCT02618694|"~     This randomized comparative study assesses the safety and efficacy of the posterior~     retroperitoneoscopic adrenalectomy in comparison to the standard, anterior transperitoneal~     approach and suppose that this new technique is a safe and effective alternative to the~     standard approach.~   "
72447|NCT02618681|"~     To investigate the feasibility of the earlobe crease as an early prognostic predictor for~     acute myocardial infarction(AMI) in Chinese population.~   "
72436|NCT02618824|"~     Terminal warm blood cardioplegia (TWBC) has been shown to enhance myocardial protection in~     adult patients. Even in pediatric patients, the use of cold blood cardioplegia followed by~     administration of TWBC will provide cardioprotective effect similar to adult patients.~     Histidine-tryptophan-ketoglutarate (HTK), is attractive for cardiac surgeons because it is~     administered as a single dose and is claimed to offer myocardial protection for a period of~     up to 180 minutes allowing performance of complex procedures without interruption. Merging~     the use of TWBC on the use of HTK cardioplegia, especially for pediatric cardiac cases, have~     not been investigated. This technique is expected to provide a longer ischemic time and a~     protective effect against reperfusion injury.~   "
72437|NCT02618811|"~     So far, the impact of sarcopenia has been analysed only in patients undergoing traditional~     surgical procedures (laparotomy) or those with metastatic spread. As the ERAS protocol~     combined with minimally invasive access decreases postoperative metabolic disorders, it seems~     possible that it can limit the deleterious impact of sarcopenia as well. The aim of this~     study was to investigate whether the use of ERAS protocol in colorectal cancer patients~     influences the postoperative risk due to sarcopenia.~   "
72438|NCT02618798|"~     Background: Thrombosis may be crucial in driving the progression of fibrosis in chronic liver~     disease (CLD). The potential role of platelets and platelet activation in this process is~     unclear. Platelets participate in inflammation by secretion of pro-inflammatory mediators~     which may advance hepatic fibrosis. Hepatitis B virus transgenic mice, developed~     significantly smaller necroinflammatory foci and their serum ALT levels were 80% lower, if~     they were pre-treated with anti-platelet antibodies. Sinusoidal aggregation of activated~     platelets also occurs in chronic hepatitis C in humans. It may contribute to thrombocytopenia~     observed in CLD. Platelet activation is generally believed to be compromised in CLD. However,~     there is data suggesting that CLD may even be associated with an enhancement of platelet~     activation. Measurement of hepatic venous pressure gradient (HVPG) constitutes the most~     common method for estimation of portal venous pressure. HVPG is significantly correlated with~     histological indices of CLD progression.~      Study hypotheses:~        1. HVPG as a marker for advancement of hepatic fibrosis and progression of CLD is~          associated with an increase in platelet activation.~        2. Platelet activation and function is not generally compromised in CLD. Comparison of~          platelet function in CLD to a control group of healthy volunteers is intended to clarify~          whether CLD leads to a manifest platelet dysfunction~      Methods: Study design is observational. 100 patients with CLD of various origins (viral,~     alcoholic, cholestatic) scheduled for routine HVPG measurement will be enrolled. 30 healthy~     volunteers will donate blood as a control group. Platelet function and activation will be~     evaluated by multiple electrode aggregometry (primary outcome variable area under the curve~     (AUC). Plasma levels of P-selectin (ELISA), PFA (Platelet Function Analyzer) 100™ parameters~     (EPI-CT and ADP-CT), percentage of P-selectin, GPIIb/IIIa, thrombin receptor positive~     platelets after stimulation (flow-cytometry) will constitute secondary outcome parameters.~     Plasmatic coagulation will be evaluated by rotational thrombelastometry (ROTEM). Platelet~     count and routine coagulation parameters will be monitored. HVPG measurement by hepatic vein~     catheterization and patient blood sampling will be carried out via the internal jugular vein.~     Blood sampling in volunteers will be performed via the antecubital vein~      Study Rationale: If higher levels of platelet activation are associated with increased HVPGs,~     this would provide an insight into the pathogenesis of CLD. It would also point toward a~     possible benefit of anti-platelet therapy in CLD. Verification of platelet dysfunction in CLD~     is relevant to clinical practice in anaesthesiology and intensive care as procedures are~     often postponed in CLD-patients for fear of bleeding complications. CLD patients may also~     receive prophylactic platelet concentrates prior to interventions which is costly, fraught~     with risk of bacterial infection and may be unnecessary in the absence of platelet~     dysfunction.~   "
72439|NCT02618785|"~     This study finds premedication Hyoscine-N-butylbromide before hysterosalpingography have a~     potential effect for diagnosis of proximal tubal obstruction in infertile women. The~     investigators did a double-blind, randomized placebo-controlled trial~   "
72440|NCT02618772|"~     Laceration repair can cause significant anxiety in children. As open wounds account for~     21-25% of injuries in children presenting to the emergency department, the management of~     anxiety is of great importance. Anxiety can often lead to poor patient cooperation and the~     use of potentially excessive physical restraint. High rates of procedural anxiety have also~     been correlated with increased rates of negative behaviours after discharge.~      The current standard of care for suture closure of lacerations throughout most of Canada is~     to provide local analgesia only. The literature has therefore focused on finding anxiolytic~     adjuncts to local analgesia.~      Midazolam is an ideal adjunct due to its fast onset and short duration of action with an~     excellent safety profile. The advantages of the IN route are less pain on administration when~     compared to the IV and IM routes, and increased acceptability compared to the rectal route in~     older children. Oral midazolam also has poor palatability.~      While the onset of INM at 5-10 minutes, and duration of 20-40 minutes make it an ideal~     candidate for anxiolysis in the ED its use has been limited by the common side effect of~     nasal irritation, burning and lacrimation when it is administered in its droplet form. The~     recent development of mucosal atomization devices (MAD) has resolved this issue by delivering~     30-μ particles to the nasal mucosa.~      Previous studies investigating the use of INM for laceration repair in the pediatric ED have~     demonstrated that INM is safe but most used non-validated measurement tools to assess anxiety~     and facilitation. Only one of these studies used atomized INM, retrospectively examining~     safety as the primary outcome. The authors reported an excellent safety profile for INM using~     the mucosal atomization device MAD-300 (Wolfe Tory Medical Inc.). The use of atomized INM for~     anxiolysis during pediatric laceration repair has not been evaluated prospectively.~      Most studies have focused on preschool aged children (<6 years). While studies have~     demonstrated that the prevalence of procedural anxiety is higher in younger children, up to~     51% of children age 7-12 years experience high levels of procedural distress. The~     effectiveness of INM in the pre-adolescent age group is, therefore, yet to be determined.~      It is hypothesized that INM will reduce anxiety in children age 2-12 years undergoing~     laceration repair and will facilitate the successful completion of suturing by the physician.~   "
72441|NCT02618759|"~     The purpose of this study is to evaluate the therapeutic efficacy and safety of DSXS compared~     to a Placebo (vehicle) in patients with mild to moderate plaque psoriasis.~   "
72442|NCT02618746|"~     COPD is the fourth leading cause of death in the world and is the only one of the top five~     illnesses whose death rate is still increasing. It is mainly caused by smoking. Greece has a~     higher prevalence and death rate for COPD than many other countries in Europe. The disease is~     incurable so treatment is aimed at alleviating symptoms and slowing progression. Despite~     maximal medication and strategies such as pulmonary rehabilitation and home nurse support,~     many patients remain vulnerable, socially isolated and report difficulty in accessing their~     local health services. Research has shown that patients have worsening symptoms for an~     average of three to four days before they are admitted to hospital with an exacerbation of~     COPD. This suggests a window of opportunity to intervene. Early warning and contact via~     innovative technology may treat symptoms earlier, improve patient confidence / quality of~     life and simultaneously reduce health care visits or admissions. However, there is a large~     gap between the postulated and empirically demonstrated benefits of electronic Health~     Technologies. In addition, there is a lack of robust research on the risks of implementing~     these technologies and their cost-effectiveness has yet to be demonstrated, despite being~     frequently promoted by policymakers as if this was a given issue. In addition, the~     evidence-base for telehealth is not well-reported in peer reviewed journals and hence there~     continue to be difficulties experienced in convincing clinicians, hospital managers and~     stakeholders that investment in such technologies will enable reductions in other aspects of~     healthcare delivery over time.~      This project attempts to provide robust justification of the effectiveness of~     telerehabilitation by the implementation of a randomized controlled trial blindly assigning~     COPD patients to: i) a home care and telerehabilitation group remotely monitored by a~     specialised private health care centre (Filoktitis - group A) or ii) a hospital-based~     rehabilitation group managed at a regular base through weekly visits by personnel at a state~     University rehabilitation centre (group B). iii) A third group that receives usual care~     (group C: control group; i.e.: neither home monitoring nor hospital based rehabilitation) is~     also included.~   "
72443|NCT02618733|"~     Recently, data (PLATO) from an AstraZeneca study of platelet inhibition and patient outcomes,~     a Phase III pivotal efficacy and safety study with a duration of up to 12 months comparing~     ticagrelor 90 mg twice daily dosing to clopidogrel 75 mg once daily dosing in acute coronary~     syndrome patients on ASA background, have demonstrated superiority of ticagrelor over~     clopidogrel in the prevention of fatal and non-fatal cardiovascular events. Currently, the~     mechanism for this mortality reduction remain uncertain. One hypothesis is a adenosine~     mediated theory that ticagrelor has been shown to enhance adenosine-induced vasodilation.~     Several experimental and clinical studies support the hypothesis that adenosine could reduce~     cardiac ischaemia reperfusion damage. Moreover, recent study has demonstrated that ticagrelor~     enhances adenosine-induced coronary vasodilatory responses in healthy humans. However, there~     are no available data on coronary circulation effects after chronic treatment of ticagrelor~     in patients with ACS who have altered resting coronary blood flow dynamics due to advanced~     coronary artery disease.~   "
72444|NCT02618720|"~     To assess the effects of a combined antimicrobial prophylaxis using oral ornidazole (the day~     before surgery) and intravenous cephalosporin (before surgical incision) with that of~     intravenous cephalosporin alone (standard of care) in combination with oral placebo on the~     incidence of SSI within 30 days after elective colorectal surgery.~   "
72445|NCT02618707|"~     Many variables measured in critically ill patients have been used to estimate severity of~     disease, prognosticate morbidity and mortality, evaluate costs of treatment, and finally~     indicate specific treatment and monitor the adequacy of treatment and its timing. It is~     unlikely that one measurement can replace all of these, but in the remainder of this~     manuscript the investigators will show that lactate levels may come close. Although in our~     mind strongly linked to tissue hypoxia, lactate levels follow many more metabolic processes~     not related to tissue hypoxia and, therefore, subject to many disturbances found in various~     clinical situations~   "
72453|NCT02618603|"~     Shoulder pain after stroke is a very common, causing significant morbidity disease.~     Subacromial and subdeltoid (SASD) bursitis are common causes of pain or disability of the~     shoulder joint in stroke patients. Traditional therapeutic approaches for the shoulder pain~     therapy including pharmacotherapy, injection therapy, physical therapy, and behavioural~     modification. Unfortunately, these therapy methods may not be effective in many patients and~     long term benefit after treatment is transient, the outcomes may also be incomplete or~     non-existent. Botulinum toxin A (BoNT-A) is a neurotoxin that can inhibit not only the~     acetylcholine at the neuromuscular junctions but also other neurotransmitters such as~     glutamate, substance P and calcitonin gene related peptide, all of which have been indicated~     in pain transmission. Despite the therapeutic benefit of BTX in alleviating painful muscle~     spasms, its efficacy in SASD bursitis conditions is less clear. So we perform this study to~     examine the efficacy of ultrasound guided SASD injection with BoNT-A in reducing refractory~     shoulder pain after stroke.~   "
72454|NCT02618590|"~     This is a multi-center retrospective study, designing to access the best treatment strategy~     in non-small cell lung cancer (NSCLC) patients harboring EGFR mutant type after first/second~     line EGFR-TKI failure. The study end point is Progression Free Survival 2 (PFS2), which is~     defined as the time period from Progression Disease 1(PD1) to Progression Disease 2(PD2). PD1~     is defined as the first tumor progression time from taking EGFR-TKI evaluated by Recist 1.1~     criterion, and PD2 as the second tumor progression time after EGFR-TKI failure no matter what~     second/third line treatment was, PD2 is also evaluated by Recist 1.1 criterion.~   "
72455|NCT02618577|"~     NOAH is an investigator-initiated, prospective, parallel-group, double-blind, randomised,~     multi-centre trial. The objective of the trial is to demonstrate that oral anticoagulation~     using the NOAC edoxaban is superior to current therapy to pre-vent stroke, systemic embolism,~     or cardiovascular death in patients with AHRE and at least two stroke risk factors but~     without AF. The trial will be conducted in several European countries.~   "
72456|NCT02618564|"~     The objective of this study is to evaluate sennosides as an adjunct to sodium picosulfate~     magnesium citrate (Pico Salax) in preparation for colonoscopy. We will compare different~     doses and administration times. The primary outcome is number of bowel motions produced.~     Secondary outcomes include the quality of bowel cleansing and patient tolerability.~   "
72457|NCT02618551|"~     Bronchial thermoplasty is a treatment for severe asthma that consist in decreasing the~     thickness of bronchial muscle by heat using a catheter inserted into the bronchi under direct~     vision with the help of an endoscope This treatment has shown efficacy on symptoms, quality~     of life and the number of exacerbations related to severe asthma.~      This clinical study evaluates the efficiency of this treatment on the dynamic hyperinflation~     phenomenon (worsening of bronchial obstruction during exercise in patients with asthma~     contributing to worsening shortness of breath).~   "
72458|NCT02618538|"~     Some women have a higher risk than others of developing breast cancer. Unhealthy lifestyles,~     high breast density, family history, obesity, the presence of biomarkers associated with~     early neoplastic changes (considered alone or in combination) are just some of main factors~     that can increase the risk of breast cancer. Women with a higher risk may need to undergo~     more intensive screening activities, which include more frequent inspections and the~     possibility of experiment different types of tests. Instead, low risk women could be screened~     at longer intervals in order to reduce the screening harms (false positive results,~     overdiagnosis, radiation exposure, discomfort caused by the test itself, etc.) The ANDROMEDA~     Study aims at creating the possibility to customize the screening paths through a combined~     analysis of the above mentioned risk factors. Women consenting to be involved in the study~     will be asked to provide information on their lifestyle habits and reproductive history.~     Furthermore a blood sample will be collected for further bio-molecular analysis purposes.~   "
72459|NCT02618525|"~     BACKGROUND AND OBJECTIVES~      The purpose of this study is to assess whether the loss of motor response to supraorbital~     pressure can be an alternative to that of jaw thrust to predict optimal condition for~     laryngeal mask airway (LMA) insertion in children.~      METHODOLOGY~      Fifty children (ASA I-II), aged 2 to 10 years, scheduled to receive general anesthesia that~     required LMA insertion were randomized to receive either supraorbital pressure (SOP) (n = 25)~     or jaw thrust (JT) (n = 25), after the loss of verbal response and body movements with a~     standard anesthetic. When motor response to the study intervention was absent, the LMA was~     inserted. Outcome parameters were ease of mouth opening, LMA insertion score, requirement of~     additional propofol to increase the depth of anesthesia, occurrence of coughing, swallowing,~     laryngospasm and gross purposeful movements during or within one minute of LMA insertion, and~     the number of failed insertions.~   "
72460|NCT02618512|"~     This study evaluated the safety and tolerability of intravenous (IV) administration of~     SBC-103 in previously studied, SBC-103 treatment naïve patients with mucopolysaccharidosis~     III, type B (MPS IIIB, Sanfilippo B) who participated in the NGLU-CL01 study. The NGLU-CL01~     study was a non-interventional study that evaluated structural brain abnormalities and blood~     brain barrier (BBB) integrity by magnetic resonance imaging (MRI) and cerebrospinal~     fluid/serum albumin index.~   "
72461|NCT02618499|"~     The purpose of this study is to determine if oxytocin administration immediately after~     delivery of the infant modifies the volume of placental transfusion in healthy term infants.~   "
72462|NCT02618486|"~     The investigators' earlier study reported a high prevalence of chronic periodontitis among~     obese Malaysian adult population. Non-surgical periodontal therapy (NSPT) has been shown to~     effectively reduce microbial load and contributes to reduction in periodontal parameters and~     inflammatory burden up to 6 months post-therapy. This study will cast light on the effects of~     obesity on chronic periodontitis (CP) patients following NSPT. The objectives of the study~     were to quantify and to compare the periodontal pathogens, serum and salivary interleukins in~     obese and non obese with CP following NSPT.~   "
72463|NCT02618473|"~     The aim of this study was to investigate the effect of a new motion correction algorithm on~     image quality and diagnostic utility in unselected patients undergoing coronary cardiac~     computed tomography, and to investigate if this motion correction algorithm can compensate~     for the usual use of intravenously medication (beta-blockers) before the scan.~   "
72846|NCT02613455|"~     The purpose of this study is to prospectively compare the pain and functional outcomes of~     patients with chronic lateral epicondylitis treated with either intratendinous corticosteroid~     injection or high energy extracorporeal shock wave therapy (ESWT).~   "
72464|NCT02618460|"~     Non-contrast enhanced (NCE) structural MRI enables to investigate renal anatomy.~      Additional NCE-MR acquisition modalities (e.g. Diffusion Weighted Imaging (DWI), Blood~     Oxygenation Level Dependent (BOLD) MRI, Arterial Spin Labeling (ASL), MR Angiography (MRA),~     phase-contrast MRI), which could be used in combination with structural MRI in a single~     acquisition session, have been identified to investigate in more detail renal function and~     structure, opening the possibility to estimate local renal diffusion and blood perfusion,~     beyond providing high-resolution anatomical accuracy.~      Preliminary to the identification of novel imaging biomarkers of renal disease progression,~     perfusion and diffusion MR sequences need to be optimized for the renal compartment.~     Moreover, NCE-MRIs acquired on healthy volunteers are required to investigate perfusion and~     diffusion changes in pathological kidneys as compared to normal and physiological condition.~      The objective of this study is to provide normal control NCE-MRI sequences to be used as~     reference for the investigation of perfusion and diffusion changes in the kidney of patients~     affected by chronic kidney disease (e.g. diabetic nephropathy, nephrosclerosis, autosomal~     dominant polycystic kidney disease).~   "
72465|NCT02618447|"~     The investigators hypothesize that 4Dimensional Phase Contrast Magnetic Resonance Angiography~     (4D PC MRA) evaluation of portal venous flow predicts underlying liver function and~     hypertrophic potential in patients with liver cancer presenting for portal vein embolization~     (PVE). 4D PC MRA may provide a non-invasive measure of liver function that could help~     determine which patients could safely and successfully undergo PVE and subsequent resection~     of tumor. By comparing 4D PC MRA results with invasive catheter measurements the~     investigators will validate the flow findings. Further regression/correlation analysis with~     functional measures of the liver (HIDA scans), volumetrics, Doppler flow analysis, histology,~     and outcomes will help the investigators to determine the ability of 4D PC MRA to predict~     functional status and hypertrophic potential of the liver prior to PVE and hepatectomy~     allowing for better patient selection and reduced morbidity/mortality.~   "
72466|NCT02618434|"~     The purpose of this study is to demonstrate the efficacy, safety and tolerability of SPN-810~     in the treatment of impulsive aggression in patients with Attention Deficit/Hyperactivity~     Disorder (ADHD) in conjunction with standard ADHD treatment. Approximately 291 subjects aged~     6 to 12 years with ADHD and comorbid impulsive aggression will be recruited in this study.~     The frequency of impulsive aggression behaviors will be assessed as a primary outcome.~     Additionally, the severity and improvement in impulsive aggression, and quality of life~     measures for the subject and caregiver will be assessed using validated scales.~   "
72467|NCT02618421|"~     The purpose of the study is to determine prevalence of lower urinary tract symptoms in~     population aged 40 years or over, in China, Taiwan and South Korea using latest ICS~     definition.~   "
72468|NCT02618408|"~     The purpose of this study is to demonstrate the efficacy, safety and tolerability of SPN-810~     in the treatment of impulsive aggression in subjects with Attention Deficit/Hyperactivity~     Disorder (ADHD) in conjunction with standard ADHD treatment. Approximately 291 subjects aged~     6 to 12 years with ADHD and comorbid impulsive aggression will be recruited in this study.~     The frequency of impulsive aggression behaviors will be assessed as a primary outcome.~     Additionally, the severity and improvement in impulsive aggression, and quality of life~     measures for the subject and caregiver will be assessed using validated scales.~   "
72469|NCT02618395|"~     Bioavailability study~   "
72470|NCT02618382|"~     This is a single center single arm study of 50 patients to 1) determine the safety of~     tranexamic acid in the chronic subdural hematoma population following surgical drainage of~     chronic subdural hematomas and 2) determine if the use of oral tranexamic acid reduces the~     rate of ipsilateral recurrence following drainage of chronic subdural hematomas. This will be~     compared to historical controls. This study intends to be a prerequisite to a large~     nationally funded randomized control trial.~   "
72471|NCT02618369|"~     The Philips Sonalleve HIFU system is expected to be efficacious in reducing pain scores in~     patients with painful osteoid osteoma and other benign bone tumors, and in reducing their~     pain medication usage. No serious adverse effects are expected to result from this treatment.~   "
72472|NCT02618356|"~     The primary endpoint is to evaluate the Median disease progression free survival (mPFS).~   "
72473|NCT02618343|"~     Nausea is a common symptom encountered in the Emergency Medical Services (EMS) environment~     that is often treated with oral or intravenous anti-emetic medications. Research Design/Plan:~     This will be a randomized equivalence study comparing the reduction in a patient's reported~     level of nausea after treatment with either Ondansetron or IPA Methods: Patients who report~     nausea and/or vomiting in the normal evaluation and care of after calling 911 for Emergency~     Medical Care will be offered enrollment in the study. A short script will be attached to the~     outside of each study packet providing information about the study and its risks and~     benefits. Verbal or written (waiver of informed consent will be requested) permission will be~     obtained to start randomization. If the patient agrees to enroll then the study packet will~     be opened and utilized. All Advanced Life Support Ambulances in the San Antonio Fire~     Department will have sealed numbered opaque boxes or envelopes with either: 70% Isopropyl~     Alcohol swabs or ondansetron. Six Visual Nausea Severity Scoring cards will be provided with~     a marking pen to record timed nausea levels before and upon arrival to the Emergency~     Department and 15 minutes after treatment whichever comes first.~      Clinical Relevance: This treatment has not been studied in the unique environment encountered~     by Paramedics in the Pre-Hospital setting. If this treatment is found to be effective, it~     many offer a very simple, extremely inexpensive and non-invasive (basic life support)~     approach for the treatment of nausea.~   "
72474|NCT02618330|"~     The aims of this study were to compare health related quality of life, comforts~     degrees，retention effectiveness, and failure rates as well as survival times between two~     clear overlay retainers with different thicknesses, thus to provide basis information~     regarding appropriate selections of the thickness of clear overlay retainers.~   "
72499|NCT02618005|"~     Human immune function and intestinal microbiota are suggested to be altered within~     long-duration stay in space. Accumulated evidences on earth support that Lactobacillus casei~     strain Shirota (LcS) is a promising probiotic strain on improvement of immune function and~     intestinal microbiota. This study aims to investigate the impact of long-duration spaceflight~     as well as intake of LcS on the international space station (ISS), on immune system and~     intestinal microbiota in astronauts.~   "
72475|NCT02618317|"~     Background: Poor flow (PF) and catheter-related blood stream infections (CRBSI) are highly~     prevalent among CKD 5D patients with long-term central venous catheters. Heparin (H) catheter~     lock solutions are commonly used to maintain catheter patency, however PF and CRBSI incidence~     remains high. The purpose of this study was to evaluate two lock solutions on reduction of PF~     and CRBSI: one, a lock solution combining of the tetracycline antibiotic minocycline with the~     anticoagulant/chelation agent EDTA (M-EDTA) versus H; and other, trisodium citrate (C) versus~     H. M-EDTA and C were also evaluated as to their safety versus H.~      Methods:As regards the pilot project, thirty CKD 5D patients on high-efficiency hemodialysis~     (blood flow rate = 350 ml/min) at the Integrated Centre of Nephrology (Guarulhos, Brazil)~     were randomized 1:1:1 to receive M-EDTA, C or H locks for 15 weeks. Lock solutions~     concentrations were M-EDTA 30 mg/ml/3 mg/ml, C 30% (C) and H 1,000 U/ml and both~     investigators and patients were blinded to treatment allocation. The primary end-point was a~     10% reduction in HD blood flow rates (35ml). The frequency of CRBSI was recorded. Bleeding~     and lock solution-related adverse events were the primary safety end points. Logistic~     Regression was performed to evaluate differences in PF rates among the treatments (SPSS~     version 13.0, IBM, USA).~      Based upon the pilot-study data, the clinical trials has being executed in order to verify~     whether the three lock solutions have the same performance or not.~   "
72476|NCT02618304|"~     In this study, investigator aim to evaluate the changes of tear-film lipid layer thickness~     and ocular aberration after treatment of meibomian gland dysfunction. In case of stage 3 or 4~     meibomian gland dysfunction, participants will be treated using conventional treatment~     modalities. Before treatment and after 1 and 2 months of treatment, a variety of ophthalmic~     examination, tear-film lipid layer thickness, and ocular aberration are going to measured and~     compared.~   "
72477|NCT02618291|"~     This study aims to test the efficacy of a comprehensive assessment and management tool (AGE:~     Active Geriatric Evaluation) for geriatric syndromes to prevent functional decline in elderly~     patients followed in family medicine. Family practitioners will be randomised either to the~     intervention, consisting of a yearly screening for eight geriatric syndromes accompanied by a~     management plan in case of positive screening, or to usual care. Level of functioning and~     quality of life of patients in both arms will be assessed over two years.~   "
72478|NCT02618278|"~     This study aims to evaluate the whether receiving physiotherapy early after onset of the~     problem is better than waiting a few weeks to see if it gets better before starting~     physiotherapy. 80 people with sciatica will take part in the study, half of which will~     receive physiotherapy 2 weeks after seeing their G.P. The other half will receive~     physiotherapy at the usual time, around 6 weeks after seeing their G.P.~   "
72479|NCT02618265|"~     The investigators want to verify whether mobile application based on stroke strengthen~     prevention management is more effective than traditional management model or open stroke~     management platform. Whole blood-impedance based platelet aggregation(WBA) method and~     VerifyNow detected by aspirin or clopidogrel responsiveness will provide individualized~     anti-platelet drug selection. Endpoint event is defined as stroke death or relapse. Primary~     measure outcomes are change of the stroke recurrence rate and mortality after secondary~     prevention.~   "
72480|NCT02618252|"~     Patients with difficulty intravenous access frequently have delay of care in emergency~     departments because Emergency Department (ED) personnel could not establish intravenous (IV)~     access for diagnostic blood test or treatment. The ultrasound machine or near-infrared~     devices have been used to improve this situation but no study has ever compared which machine~     is more efficient. This study is designed to investigate whether the ultrasound or Vein~     Viewer, which is a near-infrared device, is more efficient.~   "
72481|NCT02618239|"~     Non-absorbable, fermentable residues in the diet increase intestinal gas production and~     induce gas-related symptoms, such as flatulence, abdominal bloating and distention; however,~     prebiotics, which are also fermented by colonic bacteria have been shown to improve this type~     of symptoms. The aim is to demonstrate changes in metabolic activity of gut microbiota and~     colonic biomass induced by prebiotics.~      Healthy subjects (n=20) will be administered a prebiotic (Galacto-oligo-saccharide; 2.8 g/d)~     for 3 weeks; they will also receive a standard diet during three days. The following outcomes~     will be measured immediately before, at the beginning and at the end of the treatment: a)~     number of gas evacuations during daytime for 2 days on the standard diet, by means of an~     event marker; b) volume of gas evacuated via a rectal tube during 4 hours after a test meal,~     by means of a barostat; c) microbiota composition by fecal analysis.~   "
72482|NCT02618226|"~     Prospective study of diagnostic accuracy of optic nerve sheath diameter measurement (index~     study) in traumatic brain injury with simultaneous invasive intracranial pressure monitoring~     as the reference standard.~   "
72483|NCT02618213|"~     Bronchiolitis in infants and young children often requires respiraty support. In Denmark~     Continous Positive Airway Pressure ( CPAP) are routinely used in children with~     moderate-severe bronchiolitis. The aim of the study is to compare CPAP and High Flow~     Oxygenation Therapy (HFOT) as tools of respiratory support in infants and young children with~     bronchiolitis.~      Infants and young children with moderate-severe bronchiolitis and are randomized to either~     CPAP or HFOT.~   "
72484|NCT02618200|"~     Prostate cancer is currently detected by ultrasound-guided biopsy. Computer-aided diagnostic~     (CAD) systems based on multiparametric MRI are now capable of detecting most aggressive~     cancer foci non-invasively, but additional progress is needed for the technique to be~     accepted in clinical practice. We hypothesize that combining MRI and ultrasound imaging can~     improve the detection of cancerous tumors. As a first step in this direction, we need to~     create a database with MR images, 3D ultrasound images, and corresponding histopathology~     results, in patients treated by radical prostatectomy for prostate cancer. This is the~     purpose of the present study.~      In a later stage (outside the scope of this study), we will be learning how to combine these~     images to best recognize cancerous tumors, we will use that knowledge to develop a new CAD~     system, and we will assess the performance of the new CAD. We expect this future system to~     improve the detection of prostate cancer and to reduce the number of patients requiring~     biopsy.~   "
72485|NCT02618187|"~     A Multiple Dose Study to Evaluate the Safety, Tolerability and Microbiome Dynamics of SER-287~     in Subjects with Mild-to-Moderate Ulcerative Colitis.~   "
72865|NCT02613208|"~     This multicenter, observational, prospective study will identify a powerful and easy~     predictive/prognostic marker to use with participants under bevacizumab.~   "
72486|NCT02618174|"~     Encouraging individuals to eat vegetables is difficult. However, recent evidence suggests~     that using social-based information might help. For instance, it has been shown that if~     people think that others are eating lots of fruit and vegetables, that they will consume more~     of these foods to match the 'norm'. The purpose of this study was to determine whether a~     liking social norm (information about how much others like vegetables) would be effective at~     encouraging people to eat more vegetables and to examine whether these effects are sustained~     beyond initial exposure (i.e. whether the effect of the norm persists on food selection 24~     hours alter).~   "
72487|NCT02618161|"~     TITLE Timing of HDR brachytherapy with EBRT in intermediate and high risk localised Prostate~     CAncer patients and its effects on Toxicity and Quality of life - randomised feasibility~     trial.~      SHORT TITLE THEPCA trial Protocol Version Number and Date Version 2.1, dated 16 DEC 2014~     Study Duration Recruitment Duration 18-24 months~      Study Centre Southend University Hospital NHS Foundation Trust~      Objectives Assessment of acute toxicities: Genitourinary, gastrointestinal and sexual~     dysfunction at various time points.~      Number of Participants 50 participants~      Main Inclusion Criteria~        -  Patient age >18 years~        -  Histologically diagnosed Prostate cancer, stages T1b-T3bN0M0~        -  Any Gleason score~        -  Any PSA level~        -  Patient able to consent and fill in the questionnaires Exclusion Criteria - Previous~          TURP/HoLEP Laser Prostatectomy~        -  Any Metastatic Disease~        -  IPSS>20~        -  Pubic arch interference~        -  Lithotomy position or anaesthesia not possible~        -  Rectal fistula~        -  Prior pelvic radiotherapy Statistical Methodology and Analysis Percentages of adverse~          events will be compared using Fisher's Exact Test. Toxicity score means will be compared~          using two-sample permutation t-tests, and PSA relapse-free survival will be estimated~          using Kaplan-Meier and compared using log-rank tests.~   "
72488|NCT02618148|"~     The purpose of this study is to determine whether safety Study of Hormone replacement therapy~     (HRT) with herbals( Garlic oil+Nattokinase) for estrogen deficiency symptoms in~     perimenopausal and postmenopausal women.~   "
72489|NCT02618135|"~     This project involves creating a novel and personalised BCI training system that targets~     social and communication difficulties, and inattentive symptoms problems often found in~     ASD/ADHD children. 20 participants between the age of 8 and 12 will be recruited and they~     will undergo 24 training sessions over an 8-week period. During these sessions, the children~     will play a computer game interface specifically designed to train attention and facial and~     emotional recognition, while using our BCI device. To further reinforce the treatment, the~     training system has been enhanced with the inclusion of an eye-tracker to target the lack of~     preferential eye contact that children with ASD exhibit. The investigators hypothesize that~     participants will show improvements in social skills and attention post treatment.~   "
72490|NCT02618122|"~     This non-interventional study aims primarily at assessing the clinical effectiveness and the~     impact of the therapy on cancer-related symptoms and patients' HRQoL. In addition, it~     represents an attempt towards gaining experience on the routine use of trabectedin in daily~     clinical practice in a representative sample of Greek subjects with aSTS.~   "
72491|NCT02618109|"~     B-acute lymphoblastic leukaemia (ALL) is the most common childhood malignancy. Despite~     enhancement of childhood B-ALL outcome, relapses remain difficult to treat. Several studies~     in adult acute myeloid leukaemia have shown that proliferation of immunosuppressive cells~     -particularly T regulatory (Treg) cells and deficient natural killer (NK) cells- was~     associated with poor response to chemotherapy. However, few studies have been done on~     childhood ALL and none on relapse of B-ALL. Moreover, a newly described immunosuppressive B~     cells subset (Breg cells) seems to have a role in oncogenesis in mice model, but its~     significance has never been evaluated in human cancers. The purpose of this study is to~     prospectively evaluate the immune status of children newly diagnosed with first relapse of~     B-cell ALL, and to compare results with those of children treated for B-ALL in complete~     remission. Classic lymphocytic phenotype, proportions of immunosuppressive cells (Treg cells,~     deficient NK cells, Cytotoxic T-lymphocyte-associated protein 4 and/or Programmed T cell~     death 1) and thymopoiesis will be evaluated. The investigators assume that increase of~     immunosuppressive cells proportions could be associated with B-ALL relapse.~   "
72492|NCT02618096|"~     The purpose of this study is to compare concurrent oxytocin with membrane sweeping versus~     dinoprostone pessary in labor induction for multiparas at term with an unfavorable cervix.~   "
72493|NCT02618083|"~     Retinal detachments correspond to a separation of the neuroepithelium from the pigment~     epithelium. They can be exudative (sometimes in conjunction with a tumor), tractional,~     traumatic (postoperative) or rhegmatogenous (in relation to a tear).~      Ultrasound, requested when the fundus is difficult to achieve and shows a hyperechoic mobile~     membrane. It can also measure the hemodynamic parameters of retinal arteries.~      A preliminary study showed a correlation between systolic velocity in the central retinal~     artery and postoperative visual acuity.~      The aim of this study is to confirm those preliminary data.~   "
72494|NCT02618070|"~     In this functional magnetic resonance imaging study, effects of different information of fat~     content of high or low fat will be examined in FD patients and healthy volunteers (n=30,~     respectively). These data will provide a better understanding of symptom generation following~     food ingestion in general as well as in patients with respective functional gastrointestinal~     disorders.~   "
72495|NCT02618057|"~     Mycoplasma pneumoniae is one of the most common causes of community-acquired pneumonia in~     children. The clinical course is typically self-limited and benign; however, rare cases of~     severe pneumonia can develop despite appropriate antibiotic therapy. The investigators aim to~     study the effects of prednisolone on severe M. pneumoniae pneumonia with lobar consolidation~     or pleural effusion in children.~   "
72496|NCT02618044|"~     Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) is considered the weight loss procedure of~     choice for patients suffering of gastro-esophageal reflux (GER). However, long term~     instrumental evaluations of GER after LRYGB are not available.~      The aim of this study is to evaluate the long-term effects of laparoscopic Roux-en-Y Gastric~     Bypass (LRYGB) on gastro-esophageal function.~   "
72497|NCT02618031|"~     This study seeks to investigate the capillary index score (CIS) to further improve patient~     selection of endovascular treatment (EVT) in acute ischemic stroke (AIS).~      The hypothesis or idea being tested:~      Patients with favorable CIS who are successfully revascularized with EVT can have successful~     outcomes with an extended time window for treatment.~   "
72501|NCT02617979|"~     The study of readmission is in its infancy in the surgical world, and there are no~     prospective studies, to the investigators' knowledge, evaluating the efficacy of~     interventions on preventing readmission following pancreatectomy. Undoubtedly, patients and~     their caregivers will play a key role in any useful intervention to reduce readmission.~     Therefore, the investigators' approach is to target perioperative education and engagement of~     patients and their caregivers in the postoperative recovery of pancreatectomy patients.~   "
72502|NCT02617966|"~     Background:~      Retinal diseases cause the loss of rod and cone photoreceptors. Symptoms include vision loss~     and night blindness. Researchers want to learn about rod and cone function in healthy people~     and people with retinal disease. They want to know if how well a person sees in the dark can~     test the severity of retinal disease.~      Objectives:~      To find out if how well a person sees in the dark can test the severity of retinal disease.~     To find out if this can help detect retinal disease and track its changes.~      Eligibility:~      People ages 5 and older with:~      Retinal disease OR~      20/20 vision or better with or without correction in at least one eye~      Design:~      Participants will be screened with medical and eye history and eye exam. Those with retinal~     disease will also have:~      Eye imaging: Drops dilate the eye and pictures are taken of it.~      Visual field testing: Participants look into a bowl and press a button when they see light.~      Electroretinogram (ERG): An electrode is taped to the forehead. Participants sit in the~      dark with their eyes patched for 30 minutes. Then they get numbing drops and contact~      lenses. Participants watch lights while retina signals are recorded.~      Visit 1 will be 3-8 hours. Participants will have up to 6 more visits over 6-12 months.~     Visits include:~      Eye exam and imaging~      Time course of dark adaptation: Participants view a background light for 5 minutes then~      push a button when they see colored light.~      Dark adapted sensitivity: Participants sit in the dark for 45 minutes. They push a button~     when~      they see colored light.~      For participants with retinal disease, ERG and visual field testing~   "
72503|NCT02617953|"~     Investigation of objective tinnitus diagnosis method through measurement of continuous~     resting EEG, auditory ERP before and after Repetitive Transcranial Magnetic Stimulation~     (rTMS) treatment of tinnitus.~   "
72504|NCT02617940|"~     The aim of this study is to evaluate the efficacy of oral hygiene orientation singly,~     compared to resin-based sealants in controlling occlusal cavitated enamel lesions on primary~     and permanent molars. For this, 273 occlusal surfaces of primary molars and 273 occlusal~     surfaces of first permanent molars on 4-9 years-old children with an enamel cavitated lesion~     will be selected in 9 cities of Brazil. The surfaces will be randomly divides into 2 groups:~     oral hygiene orientation and resin-based sealant. The surfaces will be evaluated after 6 and~     12 months regarding clinical and radiographic lesions progression. The costs and~     cost-efficacy of these treatments, children's discomfort, parents'/guardians' satisfaction~     and impact on quality of life will also be investigated. Poisson regression analysis will be~     performed in order to compare the groups, through clinical and radiographic criteria. This~     test will also be used to assess the association between the group and patient discomfort and~     parents' satisfaction. Time, costs and impact on quality of life of the treatments will be~     compared by Student's t test. For all analyses, the significance level will be set at 5%.~   "
72505|NCT02617927|"~     The safety assessment of Vedolizumab during pregnancy in IBD patients.~      The primary objective of this study is:~        1. To quantify incidence of major structural birth defects and other birth outcomes in~          infants born to women with UC/CD with exposure to Entyvio compared to women with~          exposure to other biological agents or conventional IBD therapy during pregnancy~        2. To assess the health and developmental status of infants up to 1yr of age.~   "
72506|NCT02617914|"~     The acute respiratory distress syndrome (ARDS) is common condition in critical ill patients~     affecting 7.2 people / 100,000 population / year and more than 7% of patients with invasive~     mechanical ventilation for more than 24 hours. ARDS carries a high hospital mortality of up~     to 48% and consumes large amounts of critical care resources. ARDS patients often present~     with severe hypoxemia that is refractory to conventional treatment and are thus evaluated for~     extracorporeal membrane oxygenation (ECMO). However, uncertainty regarding the appropriate~     indication for ECMO and clinical evidence for ECMO as a rescue treatment are still~     controversial. In 2012 Grasso and colleagues therefore presented a case series of influenza A~     (H1N1) ARDS patients describing the use of esophageal pressure measurements for~     individualized PEEP titration to achieve an end expiratory plateau pressure of the lung~     (PPLATL) of 25cm H2O. After performing the measurements in 14 patients, ventilator settings~     could be adjusted in half of these patients by increasing PEEP which resulted in an increase~     of oxygenation measures to an extend that criteria for extracorporeal support where no longer~     met and conventional treatment with invasive mechanical ventilation could be continued.~     However, uncertainty remains as to whether these results are generalizable to ARDS of any~     cause. In addition, increasing PEEP might impact on cardiac function and might therefore be~     associated with clinical important hemodynamic effects in these patients.~      The investigators aim to evaluate hemodynamic changes in patients with severe ARDS in which~     an individualized PEEP treatment strategy can be employed. ARDS will be defined and~     stratified according to the Berlin ARDS definition. A naso-gastric probe capable of measuring~     esophageal pressure will be inserted directly after admission to the ICU as previously~     described. Invasive mechanical ventilation and oesophageal pressure measurements will be done~     using the GE Healthcare Carescape R860 ventilator. A pulmonary artery catheters (Edwards~     CCOcomb) will be inserted to evaluate the hemodynamic parameters of cardiac output, pulmonary~     artery pressures and left atrial pressures. Volumetric parameters will be measured using~     tanspulmonary thermodilution devices (Edwards EV1000). Cardiac function will be addressed in~     addition by the use of a predefined echocardiography protocol.~   "
72523|NCT02617680|"~     There is accumulating evidence that inappropriate depth of anaesthesia is associated with~     increased risk of postoperative complications including risk of death. The aim of this study~     was to identify factors determining the effective end-tidal concentration (EEtC) of~     desflurane, duration of wash in and wash out phase, and to estimate the risk of perioperative~     awareness in patients undergoing elective neurosurgical procedure.~   "
72524|NCT02617667|"~     The objective of this study is to compare the safety, efficacy, and tolerability of two~     different dose levels of CyclASol Ophthalmic Solutions to placebo (vehicle) and Restasis for~     the treatment of the signs and symptoms of Dry Eye Disease (DED).~   "
72525|NCT02617654|"~     Recent studies show that many Type 1 diabetes patients have remaining endogenous insulin~     production, albeit at low levels. Finding means to increase this production would be of~     tremendous interest, since residual C-peptide concentrations >0.1 nmol/l previously have been~     shown to markedly lower HbA1c, decrease blood glucose fluctuations and diminish the risk of~     ketoacidosis. It also substantially reduces the risks of severe hypoglycemic events and late~     complications. Liraglutide may through its incretin effect directly potentiate beta-cell~     function, but also holds the potential to be mitogenic for these cells.~      The hypothesis of the present trial is that treatment with liraglutide will not only have a~     direct effect on beta-cell function, which is more or less immediately observed, but also~     progressively improve C-peptide concentrations over time.~   "
72507|NCT02617901|"~     The Greulich and Pyle technique (G&P) is that most commonly used to assess bone age in~     children, particularly in the context of suspected skeletal dysplasia. However it has been~     shown not to be applicable to children of Asian and African ethnicity and may not be~     applicable to United Kingdom (UK) Caucasian children, who are now relatively more mature and~     larger than children of the mid 1930's (when G&P was developed). It is generally agreed that~     updated standards are required for rapid and reliable bone age assessment. The development of~     such standards requires irradiation of normal children. To do this ethically, radiation~     exposure must be kept as low as possible. Two recent studies suggest that bone age assessment~     can be reliably achieved from dual-energy x-ray absorptiometry (DXA) scans. As far as the~     investigators are aware, the Tanner & Whitehouse (TW3) method, which is preferred by some~     (e.g. endocrinologists and nutritionists), has not been assessed from dual-energy x-ray~     absorptiometry (DXA) scans - although not the main focus of this study, because of its~     popularity amongst certain specialties, the investigators shall be assessing the TW3 method~     also. Modern techniques should not only be available as textbooks, but should also be~     available in digital (on-line) format and where possible integrated with hospital PACS~     systems. The investigators believe that their team has the required experience and expertise~     to successfully carry out such a project. Before conducting the required large~     cross-sectional study, the investigators must first confirm that DXA can in fact replace~     radiographs for bone age assessment in children; which is the objective of this current~     study.~   "
72508|NCT02617888|"~     Purpose~        1. To investigate the effects of cardiac imaging radiation on the induction of DNA~          double-strand breaks by enumerating gamma-H2AX foci in blood lymphocytes and plucked~          hair follicle cells.~        2. To estimate whether the use of breast shields in cardiac computed tomographic~          angiography (CCTA) limits the effective radiation exposure of breast tissue.~   "
72509|NCT02617875|"~     The purpose of this study is to evaluate the safety and quality of a pre-hospital holistic~     multifunctional teleconsultation system. This system consists of on-line transmissions of~     vital parameters, audio- and video-signals from the scene to a telemedicine centre, where a~     trained emergency physician (tele-EMS physician) uses software-based guideline conform~     algorithms for diagnosis and treatment.~      At the prehospital emergency scene half of the patients will receive this telemedicine-based~     approach and the other half the conventional emergency physician-based care.~   "
72510|NCT02617862|"~     The purpose of this study is to compare the RetCam (Clarity Medical Systems, Pleasanton, CA)~     to a new prototype pediatric imaging system, COSMOS, produced by Phoenix Clinical~     Incorporated (PCI) (Pleasanton, CA).~   "
72511|NCT02617849|"~     This is a multi-center, open-label, Phase II clinical trial evaluating pembrolizumab in~     combination with carboplatin/paclitaxel as a treatment in unresectable locally advanced or~     metastatic melanoma.~   "
72512|NCT02617823|"~     The purpose of this study is to determine if a lateral positioning of the pregnant woman~     after epidural analgesia increases the incidence of unilateral functioning epidurals.~   "
72513|NCT02617810|"~     The purpose of this study is to evaluate effect of multiple-dose administration of~     JNJ-42847922 on the single-dose pharmacokinetics of oral midazolam and single-dose~     pharmacokinetics and pharmacodynamics of (R)- and (S)-warfarin after oral administration of~     racemic warfarin.~   "
72514|NCT02617797|"~     Urinary stress incontinence ( SUI ) is defined as an involuntary loss of urinary Complaint no~     effort According to the Consensus of the International Continence Society (Society Continene~     International - ICS) . SUI Prevalence of adult female Population and 25 % to 30 %.However,~     despite the high prevalence, many women who have symptoms of SUI or not seek treatment remain~     without resolution of symptoms.Then there is the possibility of using non-invasive~     radiofrequency and non-ablation in external urethral meatus in order to stimulate collagen~     production, as one of the pathophysiological mechanisms of stress urinary incontinence is the~     collagen deficit in the urethral wall. It is a randomized clinical trial and the group~     experimental will utilize radiofrequency and cinesioteraphy ( clinical and in home) and the~     group control utilize turn off- radiofrequency and cinesiotherapy(clinical and in home). The~     protocol f the cinesiotherapu is the same both the group, and the protocol radiofrequency the~     group experimental will 5 sessions (one per week) with temperature 38ºC during 2 minuts. The~     group control will 5 sessions (one per week) but the radiofrequency will off but glycerin is~     heated, for masking for the patient, during 2 min. The result of the treatment is assessed by~     pad test 1 hour and have others outcomes ( quality of life- Sf-26 ans King Health- and sexual~     function- FSFI questionaire)~   "
72515|NCT02617784|"~     This study is designed to assess the pharmacokinetics (PK) and safety of oseltamivir and its~     metabolite oseltamivir carboxylate in participants undergoing routine HD and CAPD for~     end-stage renal disease (ESRD). Participants will receive 6.5 and 6 weeks of the marketed~     oral oseltamivir suspension dosed according to the HD or CAPD schedule, respectively.~   "
72516|NCT02617771|"~     Up to date, some clinical trial have evaluated the efficacy and safety of Vitamin D~     supplementation in children with RRI, with no conclusive information.~      Therefore, we designed a prospective, single-blind, clinical trial to evaluate whether oral~     supplementation with vitamin D from October to April reduces the global health burden of~     recurrent respiratory tract infections in a primary care setting.~      The primary outcome was evaluated if Vitamin D supplementation during autumn and winter can~     reduce the number of respiratory tract infections in children diagnosed with recurrent~     respiratory tract infections the seasons before.~      Secondary objectives was the assessment of Vitamin D supplementation benefits on global~     socioeconomic burden of recurrent respiratory tract infections in a primary care setting,~     according to number of visits to the primary care paediatrician and use of antibiotics due to~     respiratory tract infections.~   "
72517|NCT02617758|"~     The purpose of this study is to evaluate the bioequivalence of the new formulation of~     fentanyl transdermal system (JNJ-35685-AAA-G021) compared with DURAGESIC fentanyl in healthy~     participants.~   "
72518|NCT02617745|"~     The purpose of GLIOPLAK is to evaluate the predictive value of a biological test performed in~     the radio-chemotherapy phase in patients suffering from glioblastoma. The studied parameter~     is the variation in platelet count during the radio-chemotherapy phase. The main objective is~     to identify early in Stupp protocol a group of patients having high risk to undergo~     thrombocytopenia in maintenance phase of temozolomide. With this result an algorithm of~     platelet monitoring for patients treated with Stupp protocol wil be proposed.~   "
72526|NCT02617641|"~     Acute coronary syndromes (ACS) are one of the leading causes of coronary artery disease~     mortality, and among the top reasons for health care utilization in Canada. Physical activity~     counselling is a core component of secondary prevention interventions because increased~     physical activity is associated with reduced mortality risk, improved quality of life,~     reduced coronary risk factors, and reduced health care utilization. Despite these health~     benefits, between 40% and 60% of patients after an ACS event are insufficiently active.~     Web-based interventions offer innovative alternatives for intervention delivery via the~     Internet in secondary prevention. However, there is a paucity of randomized controlled trials~     testing, in ACS patients, computer-tailored interventions that include videos within the~     tailored algorithm. The purpose of this multicenter randomized controlled trial is to test a~     web-based intervention, TAVIEenM@RCHE, that uses tailored-videos of a nurse, the 'virtual~     nurse', aimed at increasing physical activity through walking in ACS patients.~   "
72527|NCT02617628|"~     This study is a collaboration between the University of Pennsylvania, the Philadelphia Prison~     System, and the North East Treatment Center (NETSteps). It purpose is to study the impact of~     an injectable opiate addiction medication (extended release naltrexone) given before reentry~     into the community that might help to improve reconnection to healthcare and other support~     systems, and possibly help reduce recidivism.~   "
72528|NCT02617615|"~     A Phase 1, First-in-Human, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the~     Safety, Tolerability, and Pharmacokinetic Profiles of Single Ascending and Multiple Oral~     Doses of MB-110 in Healthy Volunteers and to Evaluate the Antiviral Activity of MB-110 in~     Hepatitis C Virus Infected Subjects~   "
72529|NCT02617602|"~     Goal directed therapy (GDT) utilises various monitoring techniques to assess cardiovascular~     performance and allows for timely interventions based on predetermined algorithms. The aim of~     this prospective randomised study is to evaluate the effect of GDT on major complications in~     children undergoing radical correction of congenital heart defects, complicated by acute~     heart failure. Goal directed therapy will be implemented with the aid of transpulmonary~     thermodilution and based on predetermined algorithms.~   "
72530|NCT02617589|"~     The purpose of this study is to evaluate patients with glioblastoma that is MGMT-unmethylated~     (the MGMT gene is not altered by a chemical change). Patients will receive Nivolumab every~     two weeks in addition to radiation therapy, and then every four weeks. They will be compared~     to patients receiving standard therapy with temozolomide in addition to radiation therapy.~   "
72531|NCT02617576|"~     To determine if patient satisfaction, participation, and image quality improves with flavored~     oral contrast for MR enterography.~   "
72532|NCT02617563|"~     The purpose of this study is~        -  to evaluate the effectiveness of MAST techniques for anterior/lateral and posterior~          approaches in Degenerative Disc Disease (DDD) patients with spondylolisthesis (≥ grade~          I).~        -  To assess how single or double level MAST(Minimal Access Spinal Technologies) fusion~          procedures PLIF (Posterior Lumbar Interbody Fusion), TLIF (Transforaminal Lumbar~          Interbody Fusion), DLIF (Direct Lateral Interbody Fusion), OLIF (Oblique Lumbar~          Interbody Fusion), ALIF (Anterior Lumbar Interbody Fusion), or MIDLF (Midline Lumbar~          Interbody Fusion) are used in surgical practice and to describe long-term safety and~          effectiveness in a broad patient population of patients with degenerative lumbar disc~          disease .~   "
72533|NCT02617550|"~     This study is intended to investigate the effect of nitroglycerin on vericiguat in patients~     with stable coronary artery disease (CAD). Nitroglycerin is the standard therapy to treat~     acute crisis of angina. Thus there is a high likelihood of co-administration of both drugs in~     the target indication of vericiguat, worsening heart failure (HF). Therefore, it is important~     to investigate the safety and tolerability of vericiguat and nitroglycerin, which may be used~     as unprescribed on-demand treatment by patients with acute episodes of angina pectoris.~   "
72534|NCT02617537|"~     The objective of this study is to investigate the safety and efficacy of (0.02 mg EE as~     betadex clathrate [β-CDC]) / 3 mg drospirenone (DRSP) for dysmenorrhea. In order to~     appropriately evaluate the efficacy of EE(β-CDC)/DRSP the study was set up as a~     placebo-controlled comparative study~   "
72535|NCT02617524|"~     Dedicated Sheath feasibility study: A prospective, open-label study to evaluate the~     feasibility and safety of the Valve Medical Dedicated Sheath during Balloon Aortic~     Valvuloplasty (BAV).~   "
72536|NCT02617511|"~     The purpose of this project is to evaluate whether omega-3 fatty acid supplementation~     (combined eicosapentaenoic acid and docosahexaenoic acid [EPA/DHA] supplement) augments the~     effects of a 12-week resistance training program in older men. Outcome variables include~     inflammatory biomarkers in the systemic circulation, body composition and performance~     measures. The specific inflammatory markers in the blood include: C-reactive protein, tumor~     necrosis factor-α, interleukin-1β, and interleukin-6. Remaining parameters include: body~     composition (as assessed by dual energy x-ray absorptiometry), muscle strength (as assessed~     by chest press and leg press one-repetition maximum strength tests), and functional ability~     (as assessed by timed up and go test as well as the 6-minute walking test).~   "
72537|NCT02617498|"~     Consecutive patients, who were treated for end stage liver cirrhosis by LDLT were included in~     this a prospective study.Patients enrolled in the study divided into two groups according to~     the day of surgery. The study population was divided into two groups; group (A) Parenchymal~     liver transection was performed by harmonic scalpel (HS) and group (B) Parenchymal liver~     transection was performed by spray diathermy (SD).~   "
72538|NCT02617485|"~     The aim of the study is to demonstrate the high level of biosimilarity between MabionCD20~     (MABION SA) and the reference product: MabThera (rituximab by Hoffman-La Roche) in patients~     with CD20-positive diffuse large B-cell lymphoma.~   "
72539|NCT02617472|"~     This study will assess the effectiveness of a new pelvic floor exercise device in~     strengthening pelvic floor muscles and treating urinary incontinence among women who are~     experiencing symptoms of pelvic floor weakness. The study will be conducted over 12 weeks and~     results will be collected through self-assessment questionnaires and clinical pelvic~     examination. Effectiveness outcomes will be tracked over the duration of the trial and~     measured against historical symptoms.~   "
72540|NCT02617459|"~     To evaluate the safety and efficacy of Levobetaxolol in Chinese patients with glaucoma.~   "
72866|NCT02613195|"~     The purpose of this study is to investigate whether hydrogen-rich Celsior solution improve~     the quality of aging grafts in liver/kidney transplantation.~   "
72541|NCT02617446|"~     To Assess the safety, tolerability and efficacy of two different doses of istaroxime (0.5 and~     1.0 µg/kg/min), a new agent with lusitropic and inotropic activities that improves the~     cardiac contraction-relaxation cycle. The 2 doses of istaroxime (0.5 and 1.0 µg/kg/min) will~     be infused i. v. for 24 hours in comparison with placebo, in treatment of Chinese and Italian~     patients with Acute Decompensated Heart Failure. In all the Italian patients and in a subset~     of Chinese patients pharmacokinetics and metabolism of istaroxime shall also be studied.~   "
72542|NCT02617433|"~     Rocuronium block neuromuscular transmission at the neuromuscular junction, causing paralysis~     of the affected skeletal muscles. There have been several studies reported positive~     relationship between muscle mass and amount of neuromuscular junction. The purpose of this~     study is to find relationship between muscle mass and muscle relaxation time.~   "
72543|NCT02617420|"~     This study plans to learn more about how children use their asthma medicines. The~     investigators would like to see if special electronic monitoring devices that connect to~     smartphones and computers can help children to better manage their asthma~   "
72544|NCT02617407|"~     Children undergoing Hematopoietic Stem Cell Transplantation (HSCT) have significant~     difficulties achieving good oral hygiene and dental plaque control. HSCT recipients are at a~     significant risk for bacteremia and sepsis. Livionex® toothpaste was shown to be effective in~     reducing dental plaques while containing no additives found in other toothpastes that can~     cause increased gingival irritation. The investigators hypothesize that improved oral hygiene~     in HSCT recipients and better plaque control may result in reduced oral inflammation,~     decreased amount of oral bacterial pathogens, and reduced risk of oral-pathogen related~     systemic bacterial infections. The overall goal of this prospective randomized (2:1) pilot~     study is to determine whether incorporation of the Livionex® toothpaste in the research~     regimen could reduce dental plaque.~   "
72545|NCT02617394|"~     Occasionally, doctors need to be able to see whether the diaphragm - a muscle in the chest~     that helps control breathing - is moving properly. If the diaphragm is paralyzed or not~     moving properly, this can affect a person's breathing. After certain nerve blocks - where a~     part of the body is frozen using local anesthetic - the nerve controlling diaphragm movement~     can be anesthetized, causing diaphragm paralysis. Ultrasound can be used to see the diaphragm~     and measure its movement, but the easiest and fastest way to do this is debatable. The~     investigators wish to compare two ultrasound-based methods to image diaphragm movement to see~     which one offers the quickest and easiest way to determine if the diaphragm is paralyzed.~   "
72546|NCT02617381|"~     This is not a validation study of a questionnaire. This is a multicenter diagnostic study,~     assessing the sensitivity and specificity of a simple structured questionnaire, to identify~     patients requiring further haemostatic investigations, in pre-operative patients. This study~     will also allow for the assessment of the sensitivity and specificity of the routine care~     strategy.~      All patients are recruited during the pre-anaesthesia visit by an anaesthesiologist, in~     different anaesthetic sectors each day of the week, so that different types of surgery are~     represented.~      Each day (from Monday to Friday), the first 2 eligible patients will be offered to take part~     in the study.~      Routine care strategy is not modified by the study protocol. In addition, the simple~     structured questionnaire will be completed by the patient with a research assistant after the~     pre-operative consultation As recommended in diagnostic studies, the gold standard (see~     secondary endpoint paragraph) will be performed consistently in all patients to avoid~     verification bias.~      The improvement of screening for the need of further investigations by use of the~     questionnaire compared to routine care will be measured counting how many patients are~     adequately reclassified with the questionnaire compared to the routine care strategy,~     regarding the gold standard (using the Net Reclassification Index).~   "
72547|NCT02617368|"~     Primary objective of this study was evaluate the diagnostic capacity of fourier analysis of~     keratometric data in differentiating moderate KC and FFK from healthy corneas.~      Study participants were recruited from the Cornea Outpatient service in a consecutive if~     eligible basis. Two study groups were formed: a)KC group included patients those were~     diagnosed and classified for moderate keratoconus according to the Amsler-Krumeich~     classification system, b) FFK group (FFKG) that included patients diagnosed with FFK, and c)~     Control group (CG) was formed by refractive surgery candidates. Pentacam (Pentacam HR, Oculus~     Optikgerate GmbH, Heidelberg, Germany)measurements were performed by the same experienced~     operator in a consistent way.~   "
72548|NCT02617355|"~     This study is designed to compare a new prototype surgical magnetic drape made with~     bottom-isolated ferrite magnets to 4 commercially available surgical magnetic drapes.~   "
72549|NCT02617342|"~     This study is being done to examine the impact of an interactive, social robotics program in~     helping children with autism spectrum disorders (ASD) understand emotions and how to better~     recognize emotions while interacting with others. Eligible families will be randomized to~     either the robot intervention (n=20) or a no intervention (TAU; n=20) condition for 8-14~     weeks. Assessments will occur at pre- and post-intervention as well as weekly for both~     conditions.~   "
72550|NCT02617329|"~     The purpose of this research was to investigate the clinical effects on the ESWT treatment of~     shoulder and neck pain.~   "
72551|NCT02617316|"~     The purpose of this research is to investigate the differences of landing patterns while~     running in different speed with barefoot and wearing shoe.~   "
72552|NCT02617303|"~     Falls are an important risk factor for fragility fractures. Both are associated with the~     ageing process and as they rise also increase the risk of mortality, disability and~     dependency. Interventions to prevent falls have been based on multifactorial approaches but~     the outcomes have shown little effectiveness. Lately, it is being recommended interventions~     which foster physical exercise incorporating it to daily life activities. The OTAGO exercise~     programme is based on easy physical exercises for older adults and has shown cost-effective~     outcomes for falls prevention and its consequences.~   "
72575|NCT02617004|"~     The purpose of this study is to prospectively validate the new risk model, based on minimal~     residual disease (MRD) response level and oncogenetic status by comparing historical results~     of GRAALL-2005 with those of GRAALL-2014 in an identical population of patients (Philadelphia~     chromosome negative, B lineage ALL, aged 18 to 59 years old).~   "
72553|NCT02617290|"~     The new P2Y12 inhibitors prasugrel (Efient®-Effient®) and ticagrelor (Brilique®-Brilinta®)~     have shown promising results in the respective TRITON and PLATO trials making of prasugrel~     and ticagrelor recommended first line treatments for acute coronary syndrome ACS (ESC~     Guidelines: Class 1 LOE B). These two drugs showed superiority over clopidogrel in ACS~     patients undergoing percutaneous coronary intervention (PCI), by the dramatic diminution of~     stent thrombosis, the reduction in death or Myocardial Infarction (MI) as well as the~     reduction in death in a meta-analysis.~      The field of elective PCI (stable patients) has not been studied with these 2 new drugs and~     clopidogrel remains the standard of care. However, off-label use of prasugrel and ticagrelor~     is increasing in patients undergoing high risk elective PCI (left main, diabetics, multiple~     stenting, high risk of stent thrombosis, no clopidogrel pretreatment…) but is not supported~     by scientific evidence. More than half of PCI patients undergo elective stenting for proven~     ischemia and/or stable angina, a relatively safe procedure with the use of the latest~     generation of stents. However complications remain either frequent when considering~     PCI-related myonecrosis/myocardial injury that have been linked to the prognosis of patients~     or rare but serious when considering stent thrombosis, Q wave MI or stroke, leaving room for~     improvement with these two newest drugs.~      The investigators propose to perform a multicenter international study in stable patients~     undergoing elective PCI with a randomization between clopidogrel and ticagrelor. The~     investigators hypothesize that this study will show superiority of the new P2Y12 inhibitor~     over clopidogrel in elective PCI on the primary ischemic endpoint (peri-procedural MI and~     myocardial injury) without significant excess bleeding (BARC definition).~   "
72554|NCT02617277|"~     This study will assess the safety, tolerability and pharmacokinetics of AZD1775 given orally~     in combination with intravenous MEDI4736. Secondly, the immunogenicity, pharmacodynamics, and~     preliminary anti-tumour activity will be determined in patients with refractory solid tumours~   "
72555|NCT02617264|"~     To assess feasibility and clinical utility of marking biopsied axillary lymph nodes with Spot~     at time of biopsy.~   "
72556|NCT02617251|"~     Many studies have shown that deprived patients consumed more healthcare resources than~     non-deprived patients, in particular in terms of increased length of stay (LOS) and~     readmission rates, which has an impact on hospital efficiency and the healthcare system as a~     whole. There are many types of indicators available to assess deprivation in a hospital~     setting and French decision makers are currently using reliance on public aids to allocate~     additional funding to hospitals, based on the percentage of deprived patients they admit.~     However there are limits to this method: it only assesses one dimension of deprivation, the~     target population often does not know about the existence of those aids, and they have a~     clear threshold effect. An alternative solution is to use ecological deprivation indices~     which are obtained by aggregating different variables measured at a specific time and place,~     i.e. the patient's place of residence at the time of care. One such index, the FDep , was~     developed specifically in France, although others such as the Carstairs index and the~     European deprivation index also exist.~      The primary objective of this study is to study the association between deprivation, measured~     by the FDep, and hospital care efficiency in paediatric and neonatology patients, measured by~     the difference between patient LOS and the national average LOS of their diagnosis-related~     group, DRG). The secondary objectives are to carry out a budget impact analysis on the impact~     of deprivation for hospitals with a paediatric or neonatology ward, to study the association~     between deprivation and readmission at 15 days, to study the relation between FDep and the~     currently used deprivation indicators, and to assess the added value of the FDep compared to~     those indicators and whether or not it should be used in routine practice.~      In order to do so, an exhaustive retrospective study using the French hospital claims~     database will be carried out for the years 2012-2014. Deprivation indices will be calculated~     based on patients' postcode. The primary endpoint will be calculated using the national LOS~     present in the French national cost study. Similarly, the budget impact will look at the~     difference between production costs derived from the national cost study after adjusting for~     LOS and the statutory health insurance's tariffs, which will allow us to assess whether a~     hospital stay is associated with a gain, a loss or is budget-neutral for the hospital.~     Readmissions at 15 days will be identified through record linkage.~      Descriptive analyses will summarise both hospital and patient characteristics. Uni- and~     bivariate analyses will be carried out by focusing of the variables of interest (e.g. average~     deprivation index by legal status of the hospital, mean LOS depending on the number of~     paediatric beds etc.). The deprivation index will be divided into quantiles as is the norm~     and the endpoints will be assessed for each of those quantiles. An ANOVA (or a Kruskal-Wallis~     test if the ANOVA hypotheses are not met) will test whether the results differ between each~     quantile. For readmission rates, a Chi² test will be performed.~      In order to study the association between deprivation and the endpoints, the investigators~     will model each endpoint using as the main explanatory variable the deprivation index. Three~     main types of explanatory variables will be added to the model: patient characteristics (age,~     sex, severity level etc.), hospital characteristics (legal status, size, number of full-time~     equivalent etc.) and environment/context characteristics (number of paediatricians for 1,000~     inhabitants, rural vs. urban area etc.).~      In order to assess the added benefit of using the deprivation index vs. the current~     indicators, a sub-cohort will be constructed in Paris teaching hospitals (AP-HP) as~     unfortunately, whether the patient receives public aids is not present in the hospital claim~     database but is available only at the local level. The investigators will look at the~     distribution of patients with public aids in each quantile of the deprivation index and run~     the previous models using the two types of indicators one after the other and comparing the~     statistical performance of each pair of models.~   "
72557|NCT02617238|"~     Randomised two parallel groups multicenter study using a Prospective Randomised Open Blinded~     End-point design (PROBE), aiming at comparing the efficacy of a therapeutic strategy~     targeting the normalisation of arterial stiffness for reducing cardiovascular (CV) and renal~     events, in comparison with a classical therapeutic strategy implementing the European Society~     of Hypertension-European Society of Cardiology (ESH-ESC) Guidelines, in patients with~     essential hypertension and medium-to-very high CV risk.~   "
72558|NCT02617225|"~     The United Nation's International Children's Emergency Fund (UNICEF) is supporting Saba~     Shikha Abihyan (SSA) (Education-for-All Mission) of the Government of Assam (GoA) under their~     Water-Sanitation-Hygiene in School (WinS) program to improve WASH facilities, practices and~     institutionalize WASH in school settings. Under the WinS program, UNICEF piloted a group hand~     washing program in 100 elementary schools. Multiple past studies have shown that handwashing~     is an effective intervention to reduce diarrheal diseases and respiratory tract infections,~     but the evidence on the interventions or programs that can achieve this behavior change is~     mixed and limited in case of school setting. The main objective of Daily Handwashing for an~     Ailment-free Life (DHaAL) program was to institutionalize handwashing with soap before~     consuming mid-day meals and after using toilets among elementary school students. DHaAL is~     implemented on the Mid-day Meal platform where free meals are given to all students attending~     government schools.~      In addition to the standard DHaAL intervention, several pilot phase schools also received an~     additional program for a holistic and participatory development of school systems for health,~     nutrition, learning outcomes and wellbeing of children called Child Friendly School System~     (CFSS). Although CFSS is not a WASH intervention it can develop systems and processes and~     offer longer support from and implementing agencies which help DHaAL Intervention also.~      This evaluation study seeks to answer whether DHaAL improved handwashing practice before the~     mid-day meals in rural lower primary schools as a primary research question. The intermediate~     outputs and secondary outcomes evaluated in this study include functionality of handwashing~     infrastructure at school, handwashing practice after toilet use, and availability of and use~     of handwashing facilities at homes (indirect effect). The evaluation study has other~     supplemental operations research objectives to help improve the program in future.~   "
72559|NCT02617212|"~     The purpose of this study is to investigate whether the immediate definitive abutment~     connection to dental implant is effective in preventing marginal bone loss when compared to~     the conventional treatment with late abutment/implant connection, which include three~     disconnections and reconnections.~   "
72560|NCT02617199|"~     Acute pancreatitis is a common urgency with a mortality rate of up to 30% , decreased blood~     flow in the pancreatic microcirculation. It seems to be the main cause of the pathophysiology~     of acute pancreatitis. Today, there have been many attempts in the management of pancreatitis~     but no established management seems to be ideal. The epidural block is an anesthetic~     technique used to provide highly peri and post-operative analgesia, also plays an important~     role in improving the gastrointestinal vascular perfusion (due to sympathetic blockade that~     this technique produces) so this anesthetic technique is proposed as an alternative to both~     clinical treatment as an analgesic for acute pancreatitis.~   "
72561|NCT02617186|"~     During video-assisted thoracoscopic lobectomy (VATS), the surgeon inserts a small camera~     attached to a thoracoscope that puts the image onto a video screen. Instruments are inserted~     via small incisions, and the lung resection is completed. Robotic thoracic surgery (RTS) uses~     a similar minimally invasive approach, but the very precise instruments involved with RTS~     allow the surgeon to view the lung using 3-dimensional imaging. The instruments give the~     surgeons increased range of motion during the surgery, and research demonstrates that RTS has~     a less steep learning curve as compared to VATS. Both VATS and RTS demonstrated better~     results as compared to traditional thoracotomy (open surgery). However, Robotic lobectomy has~     not yet been compared directly to video-assisted thoracoscopic lobectomy (VATS) in a~     prospective manner.~      There are two major barriers against the widespread adoption of robotic thoracic surgery. The~     first barrier is the lack of high-quality prospective data. To our knowledge, there are no~     prospective trials comparing VATS to RTS for early stage lung cancer. The second major~     barrier to the widespread adoption of robotic technology in thoracic surgery is the perceived~     higher cost of Robotic lobectomy. To address these barriers, the investigators will undertake~     the first randomized controlled trial comparing Thoracoscopic Lobectomy to Robotic Lobectomy~     for early stage lung cancer.~      Prospective randomization will eliminate the biases of retrospective data and will serve to~     determine whether there exist any advantages to Health Related Quality of life (HRQOL) or~     patient outcomes in favour of Robotic Lobectomy over VATS Lobectomy. Furthermore, through a~     prospective cost-utility analysis, this trial will provide the highest quality data to~     evaluate the true economic impact of robotic technology in thoracic surgery in a Canadian~     health system.~   "
72562|NCT02617173|"~     Oligozoospermia, refers to a low concentration of sperm. A low sperm count or poor sperm~     quality is the cause of infertility in about 20% of couples with fertility problems, and a~     contributory factor in a further 25% of couples. In the majority of cases, no cause can be~     found. For mild male infertility, intra uterine insemination (IUI) is the procedure of choice~     with a pregnancy rate of 6.5%. In IUI, sperm is inserted using a thin, flexible catheter~     directly into a woman's uterus.~      Azoospermia affects 1% of the male population and 20% of male infertility situations. Over~     50% of azoospermic cases are due to testicular failure, including absence or failed~     production as well as low production and maturation arrest during the process of~     spermatogenesis. ICSI allows successful fertilization even with immature sperm obtained~     directly from testicular tissue. This is done through TESA (Testicular sperm aspiration) or~     TESE (Testicular sperm extraction). In cases of TESE small strips of testicular tissue are~     extracted with the intention of finding few viable sperm cells to be used for IVF or ICSI.~     Men with non-obstructive azoospermia have 0 to 3 mature spermatids per seminiferous tubule in~     contrast to 17-35 mature spermatids in men with normal spermatogenesis. TESE success rates~     are approximately 50% but differ according to etiology. Unfortunately, there is no method of~     pointing out where sperm may be found. TESE is accompanied with pain, tissue loss, reduced~     success in future TESE due to tissue scaring and testosterone deficiency.~      The complex process of spermatogenesis includes maturation of young spermatids into~     spermatozoas, a process which takes approximately 74 days. During spermatogenesis,~     spermatogonial stem cells are transformed into spermatids and released from the seminiferous~     tubule epithelium into its lumen. Non-motile spermatozoa are transported through the~     seminifreous tubules to the epididymis by testicular fluid secreted from the Sertoli cells~     with the aid of peristaltic contraction. During transport through the epididymis, sperm cells~     develop the ability to progress forward, undergo capacitation and attach and penetrate the~     egg.~      The electric charge of the spermatic cell has been termed zeta potential (electrokinetic~     potential) and is defined as the electric potential in the slip plane between the sperm~     membrane and its surroundings. Mature sperm possess an electric charge of −16 to −20 mV.~      In the animal study conducted, positive electrical current with a low amplitude bellow~     sensation level was situated around the scrotum of four normospermic and one oligospermic~     male pigs. At the end of the research the concentration of spermatocytes in the epididymis~     obtained in surgery was found to be 200 to 1600 percent above the baseline.~      Our intention is to evaluate if positive electrical current with a low amplitude bellow~     sensation level situated on the scrotum will increase the concentration of spermatocytes in~     the ejaculate.~      If our hypothesis is confirmed this may become a method for treating male infertility. The~     period of improvement is still unclear.~   "
72576|NCT02616991|"~     The purpose of this study is to determine whether systematically performing computed~     tomography (CT) venography (i.e a CT acquisition of the pelvis and of the lower limbs, during~     the venous phase of opacification) in addition to thoracic CT angiography in women with~     suspected postpartum pulmonary embolism (PE) results in a gain in venous thromboembolism~     detection rate.~   "
72577|NCT02616978|"~     This is an Internet survey to collect data on the use of the Cefaly device to treat migraine~     attacks in regular Cefaly users.~   "
72578|NCT02616965|"~     This is a Phase I Trial to assess the feasibility of Romidepsin combined with Brentuximab~     Vedotin for patients requiring Systemic Therapy for Cutaneous T-cell Lymphoma.~   "
72579|NCT02616952|"~     The purpose of this study is to determine whether Yiqi Suoquan Tang, a Chinese Herbal~     decoction, is effective in the treatment of female stress urinary incontinence.~   "
72580|NCT02616939|"~     Clinical evaluation of a new cardiovascular oriented CT scanner from Arineta Ltd.~   "
72563|NCT02617160|"~     Pump therapy is gaining popularity as a treatment mode for patients with type 1 diabetes.~     Utilizing pump therapy requires the development and application of a new spectrum of~     theoretical knowledge and practical skills by the patient. Furthermore, occasionally there is~     a need to tailor the pump settings, i.e. the insulin correction factor, carbohydrate ratio,~     basal plan and insulin activity time, in order to optimize and improve glucose control. These~     adjustments are based on collected information including insulin delivery, blood glucose~     measurements, continuous glucose monitoring data, meals and so on. Analyzing this multitude~     of information and data is overwhelming for many of the patients, caregivers and health care~     providers. Unfortunately, not all physicians have the needed expertise to fully fulfill this~     task, and for those who do, it is time consuming. Thus, a summary of the data with insulin~     dose adjustment suggestions is missing. An automated tool for pump setting adjustments will~     improve glycemic control without escalating the burden on patients and the health care~     system. Such advisor can assist the professional team during routine follow-up and the~     patients between visits.~      To address this challenge, the investigators developed the MD-Logic Pump Advisor (MDPA),~     which automatically analyses treatment information, learns patient's needs and accordingly~     suggests adjustments in insulin dosing. The MDPA uses information gathered from glucose~     monitoring, insulin dosing and meal data during daily routine home care. Following a 5 minute~     data collection and analysis, the algorithm learns and suggests pump-setting changes for~     optimization of glucose control.~      This study aims to evaluate the efficacy and safety of the Advisor Pro. The study will~     include three segments:~      Segment A - a randomized controlled parallel study, Segment B- a clinic prospective study~     during which the Advisor Pro will be evaluated during routine clinical visits as an added~     tool for physicians and Segment C- a clinical prospective parallel study for patients treated~     with pump therapy and SMBG only.~   "
72564|NCT02617147|"~     The purpose of this study is to assess the influence of vitrectomy on changes in central~     choroidea and comparing the results in imaging of the choroidea with two different OCT~     devices.~      This is a prospective, open, non-randomized, observational, MPG study This study will be~     performed at the Department of Ophthalmology, Medical University of Vienna.~      40 Patients who undergo vitrectomy will be included into this study. The investigation will~     help to gain new information about the effects of vitrectomy on the choroid.~   "
72565|NCT02617134|"~     The purpose of this study is to evaluate the safety and effectiveness of CAR-T cell~     immunotherapy in patients with MUC1 positive relapsed or refractory solid tumor.~   "
72566|NCT02617121|"~     This study was designed to compare the effects of gabapentin and ramosetron on PONV in~     patients undergoing laparoscopic gynecologic surgery.~   "
72567|NCT02617108|"~     Patients who want to go TCRS will randomly divided 2 groups. In Group 1 (100 patients), a~     Foley catheter with the balloon inflated with 4 ml of normal saline solution will be placed~     into the uterine cavity at the end of the operation for five days. In Group 2 (110 patients),~     women will not receive any of the treatment (comparison group). All subjects underwent two~     further hysteroscopy, one and three months after the initial surgery. At the second or third~     look hysteroscopy, the incidence of intra-uterine adhesion will be analyzed.~   "
72568|NCT02617095|"~     The purpose of this study is to compare the efficacy and safety of T2762 versus Optive® in~     the treatment of moderate to severe Dry Eye Syndrome.~   "
72569|NCT02617082|"~     This study is designed to evaluate the feasibility and safety of partial breast irradiation~     for low risk DCIS after breast-conserving surgery.~   "
72570|NCT02617069|"~     The aim of this prospective randomized double-blind study was to compare the efficacy of~     botulinum toxin injection in epicardial fat pads for preventing recurrences (in early~     postoperative period) of atrial tachyarrhythmia in patients undergoing cardiac surgery.~   "
72571|NCT02617056|"~     It is generally acknowledged that patients with dementia are best cared for at home. However,~     outbursts of various behavioral disturbances, e.g., combativeness, appear in most cases and~     often necessitate institutionalization. These outbursts are often without apparent warning,~     which limits preventive interventions. The measurement of the electrical activity of the skin~     is well-studied as an indicator of stress or agitation. The investigators propose to monitor~     the electrical activity of skin in patients with dementia in order to determine whether any~     sign of agitation may occur before the outburst. If skin electrical activity gives sufficient~     warning, then preventive interventions may be tried. If successful, the ability to predict~     and prevent outbursts of behavioral disturbances will allow patients to be cared for at home~     for longer periods. It is the primary aim of this project to determine whether skin~     electrical activity gives such a warning; possible preventive measures will be the subject of~     future studies.~   "
72572|NCT02617043|"~     The study was designed to evaluate the feasibility and safety of hypofractionated~     whole-breast irradiation with simultaneously integrated boost for early-stage breast cancer~     after breast conserving surgery in Chinese population.~   "
72573|NCT02617030|"~     Investigation in 3 steps the transition of young people with chronic diseases. FIRST STEP:~     qualitative survey. Interviews with carers, young people and parents. Chronic Diseases~     studied: epilepsy, HIV, sickle cell disease, obesity. SECOND STEP: Delphi consensus survey.~     Vote on internet : carers, patients' associations, young people and family. Chronic Diseases~     studied: all. THIRD STEP: validation survey. Vote on internet : young people. Chronic~     Diseases studied: all.~   "
72574|NCT02617017|"~     Parkinson's disease (PD) is one of the most common neurodegenerative diseases, with a higher~     prevalence in the elderly. Levodopa induced dyskinesias (LID) are a major motor complications~     that impair quality of life for patients with PD. The mechanisms of these dyskinesias remain~     unclear, but several hypotheses have been put forward: non continuous, pulsatile stimulation~     of dopaminergic receptors, or alterations of other neurotransmitters within the motor~     striatum such as glutamate and serotonin.~      Few strategies are now available to treat severe LID:~        -  Medications: reduction of dopaminergic treatment, addition of amantadine,~        -  Functional neurosurgery. The purpose of this study is to investigate the efficacy of~          buspirone in PD patients suffering from dyskinesias. The role of serotonin in the~          occurrence of LID was recently demonstrated in transplant PD patients and a test~          double-blind, single dose was achieved. Following administration of 10 mg oral~          buspirone, a 5HT1A agonist, LID were clearly improved. A antidyskinetic effect of~          buspirone had already been reported in 1991 and 1994, but identification of buspirone as~          a serotonin receptor agonist has been reported more recently.~      This trial is aimed at (1) validate the serotoninergic hypothesis of hyperkinetic levodopa~     induced dyskinesias (LID) in Pakinson's disease patients, (2) evaluate, in a phase 3 trial,~     the motor efficacy of buspirone to improve LID vs placebo, (3) look at a possible dose/effect~     relationship and (4) check the hypothesis of a better therapeutic ratio using the association~     of buspirone and amantadine instead than a single drug.~   "
72647|NCT02616068|"~     This study evaluates the non-inferiority of the new transdermal patch dosage form containing~     loxoprofen sodium (100 mg - Daiichi-Sankyo) in comparison with oral Loxonin® (60 mg tablet -~     Daiichi-Sankyo) for the treatment of acute traumatic injuries.~   "
72581|NCT02616926|"~     Hepatocellular carcinoma (HCC) is the sixth most common cancer in the world. For patients~     with intermediate HCC (BCLC stage B), transarterial chemoembolization (TACE) has been~     recommended as the standard therapy in many clinical practice guidelines. The combination of~     TACE and radiofrequency ablation (RFA) has also been reported as an effective treatment.~     However, more and more retrospective studies have reported better therapeutic efficacy of~     hepatic resection than TACE for intermediate HCC. The purpose of this study was to compare~     the efficacy of hepatic resection versus TACE+RFA for the treatment of intermediate HCC~     through prospective randomized clinical trial.~   "
72582|NCT02616913|"~     This study evaluates if a single oral dose of 150 mg of the novel food ingredient (AME001,~     R,R-monatin) does not have an effect on the Fridericia-corrected QT ECG interval (QTcF)~     exceeding 10 milliseconds (msec). Each subject will consume test article (150 mg), placebo,~     and moxifloxacin (400 mg; positive control) in each of 3 treatment periods.~   "
72583|NCT02616900|"~     The eSight Quality of Life and Efficacy Study (eQUEST) is a prospective cohort study~     intended to demonstrate the functional vision and Quality of Life (QoL) improvement provided~     by eSight Eyewear to persons with significant visual impairment resulting from various eye~     conditions. The multi-site study will evaluate the efficacy of the eSight device for various~     Activities of Daily Living (ADLs) across a broad range of subject ages and disease types.~   "
72584|NCT02616887|"~     Based on the known efficacy of ablative single dose SBRT and VMAT technique in various solid~     tumors, investigators have designed this study to assess feasibility of SBRT in selected~     patients with spine metastases.~   "
72585|NCT02616874|"~     The BCN02-Romi study aims to evaluate a combined kick and kill strategy using the most~     immunogenic candidate vaccine available so far (HIVconsv) with the strongest latency reversal~     agent available at present time (romidepsin) in a cohort of early-treated HIV positive~     individuals.~   "
72586|NCT02616861|"~     Stage 1: To assess the safety, tolerability, pharmacokinetic (PK) profile, and~     pharmacodynamic (PD) effects of the IW-1973 Tablet administered orally to healthy volunteers,~     in fed and fasted states, in a single-dose crossover study.~      Stage 2: To assess the safety, tolerability, PK profile, and PD effects of a range of doses~     of IW-1973 Tablet administered orally to healthy subjects in a 21-day, multiple~     ascending-dose study with optional up-titration of dose level within cohort.~   "
72587|NCT02616848|"~     Treatment of triple negative breast cancer (TNBC) relies heavily on different regimes of~     chemotherapeutic agents but remains one of the most challenging subtypes to treat because of~     the lack of specific therapies. Despite being sensitive to chemotherapy, many women with TNBC~     relapse quickly, developing locoregional recurrence or visceral metastasis. Toxicity and~     chemotherapy resistance are still major limitations in the treatment of patients with TNBC.~     Despite current trend of targeted therapy development, cytotoxic agents are a mainstay of~     treatment of patients with breast cancer. Further research into new combination of different~     compounds is needed in order to maximise benefit, whilst minimising toxicity.~      The phosphoinositide 3-kinase (PI3K) pathway is associated with resistance to a variety of~     anti-tumor agents. This has been described pre-clinically with cytotoxic chemotherapeutic~     agents with varying mechanisms of action including taxanes, and DNA-damaging agents. In the~     clinic, activated PI3K in tumors has been correlated with decreased response to therapy and~     worse clinical outcomes.~      The recent biological findings suggest that a PI3K/mammalian target of rapamycin (mTOR)~     inhibitors may increase the efficacy of chemotherapeutic agents which are considered standard~     of care (SOC) for the treatment of several solid tumors.~      The study by the Unitaed state Oncology Research of Huston and the Sarah Cannon Cancer Center~     randomized 1830 patients with high risk breast cancer to the standard adjuvant treatment with~     adriamicin cyclophosphamide followed by paclitaxel versus the experimental adjuvant treatment~     with adriamicin taxotere (AT) followed by paclitaxel. At 5-years of follow up, the AT~     followed by paclitaxel produced significantly better overall survival (p=0.054) and improved~     disease free survival (DFS) (p=0.19). Among TNBC patients both DFS (74% versus 79%, p=0.1)~     and overall survival (OS) (79% versus 84%, p=0.037) were better in experimental arm. However,~     the main reasons for patients being taken off study treatment were toxicity (85 patients in~     the control arm and 128 in the experimental arm) and consent withdrawal (18 patients in the~     control arm and 30 patients in the experimental arm). For this reason, research into~     alternatives has intensified, thus resulting in the discovery and development of new~     compounds with a more tolerable profile as compared with paclitaxel.~      Among the total of 762 patients enrolled into Eisai Metastatic Breast Cancer Study Assessing~     Physician's Choice Versus E7389 (EMBRACE) trial, 19% had TNBC. Of note, eribulin was most~     effective in hormone receptor-negative patients and in TNBC patients, who had a 29% risk~     reduction. Treatment with eribulin was well tolerated. Neutropenia, leucopenia, peripheral~     neuropathy, and asthenia/fatigue were the most common adverse events reported at Common~     Terminology Criteria for Adverse Events (CTCAE) grades 3 and 4. Neutropenia was the most~     common adverse events reported at CTCAE grade 4 in the eribulin group (24.1%).~      Based on findings to date, eribulin is an attractive agent, and its role in combination with~     new compounds such as everolimus deserves further investigations. Their combination might~     lead to more profound effects on tumor cell biology of triple negative metastatic breast~     cancer.~      During the course of the trial, dose reductions for each combination will be permitted in~     patients who cannot tolerate the starting dose~   "
72588|NCT02616835|"~     This research seeks to study the physiological effects of theta-burst transcranial magnetic~     stimulation (TMS) in the brains of healthy controls using functional MRI and spectroscopy.~   "
72589|NCT02616822|"~     Arterial Hypertension (HBP) has a high prevalence and low rates of control, is considered a~     major modifiable risk factors and one of the most important public health problems. Mortality~     from cardiovascular disease increases progressively with increasing blood pressure (BP) in a~     linear, continuous and independent. The pathophysiological mechanisms involved in the~     pathogenesis of hypertension exhibit metabolic abnormalities, which are related to~     endothelial dysfunction. Resveratrol, a polyphenol stilbene derived from various species of~     plants, but in our food, mainly present in red wine and grapes, has shown protective effects~     in cardiovascular diseases, such as preventing the damage caused by oxidative stress,~     decreased plasma lipids with inhibiting the formation of atherosclerotic plaque; protective~     effect of vascular endothelium, with increased release of nitric oxide and decreased~     production of free radicals in animal models, but human studies are limited and insufficient~     to clarify the possible effects of trans-resveratrol (biologically active form) on~     endothelial function, blood pressure and central aortic pressure in treated hypertensive~     individuals.The aim of this study is to evaluate the acute effects of trans-resveratrol~     supplementation on endothelial function in treated hypertensive patients.~   "
72590|NCT02616809|"~     This study aims to test the short-term effects of intermittent standing, slow cycling and~     slow walking, compared to sitting, on continuous blood glucose and ambulatory blood pressure~     among pre-hypertensive and pre-diabetic adults.~   "
72591|NCT02616796|"~     The purpose of the study is to evaluate a 2-3 day treatment probe targeted to improving~     social gaze behavior in children with fragile X syndrome (FXS). The investigators will use~     the principles of Applied Behavior Analysis (ABA) to shape appropriate social skills.~     Importantly, the investigators propose to examine the effects of this treatment probe on~     brain and behavior.~   "
72592|NCT02616783|"~     This primary objective of this study is to evaluate the safety of~     elvitegravir/cobicistat/emtricitabine/ tenofovir alafenamide (E/C/F/TAF) relative to~     unchanged current antiretroviral therapy (ART) by assessing spine and hip bone mineral~     density (BMD) measured at Week 48 in virologically-suppressed, HIV-1 infected participants~     aged ≥ 60 years.~   "
72593|NCT02616770|"~     To evaluate the safety and tolerability of S-1226 composed of perflubron with ascending doses~     of carbon dioxide (4%, 8%, and 12% CO2) administered over 2 minute nebulisation to healthy~     subjects.~   "
72594|NCT02616757|"~     Simple bone cysts (SBCs), also known as unicameral bone cysts (UBCs), are benign bone~     lesions. Literature to date describes little agreement between clinicians on specific~     prognostic criteria for the prediction of cyst healing, recurrence or fracture. Evidence has~     shown that bone mineral density (BMD) is a reliable indicator of risk to SBC patients given~     its association with the mechanical properties of bone. There has been further exploration~     into the use of quantitative ultrasound to assess bone density by measuring the velocity of~     the ultrasound transmission over the bone. To determine whether the QUS can provide~     prognostic information with respect to cyst healing, recurrence or fracture with a SBC,~     further study is needed.~   "
72595|NCT02616744|"~     A single--blind, randomized, placebo--controlled phase II study to evaluate the impact of~     oral bisphosphonate treatment on bone mineral density in osteopenic women receiving aromatase~     inhibitors as adjuvant treatment.~   "
72596|NCT02616731|"~     To compare the efficacy of tranexamic acid and diosmin in reducing menstrual blood loss in~     women having Intra Uterine Contraceptive Device (IUD) and suffer from menorrhagia.~   "
72648|NCT02616055|"~     Subjects who received tesevatinib in Study KD019-101 and completed 24 months of treatment~     will continue on the dose of tesevatinib they were receiving at 24 months on the KD019-101~     study.~   "
85595|NCT02446652|"~     The purpose of this study is to determine the efficacy and safety the combination of~     TRANSKRIP ® vs placebo plus Carboplatin/Paclitaxel as first line treatment in patients with~     recurrent-persistent cervical cancer.~   "
72597|NCT02616718|"~     This is a prospective multicenter study of patients diagnosed with a medium to giant~     incisional hernia (transverse defect >7 cm). Patients referred to the surgical outpatient~     clinic are invited to participate in the study. As a standard, all patients who are examined~     for incisional hernia undergo CT scan according to a hernia protocol, before planning of~     surgical repair (baseline scan). After this CT scan, patients are seen in the out-patient~     clinic once again and either treated conservatively without surgery, or scheduled for~     elective surgical repair of the hernia.~      If surgery is planned, the patients participating in the study undergo an additional CT scan~     in hernia protocol, within two weeks prior to surgery (follow-up scan).~      If a conservative non-surgical approach is chosen, patients can still participate in the~     study and will undergo an additional CT scan after 28-32 weeks.~   "
72598|NCT02616705|"~     Immunoglobulin G4-related disease (IgG4-RD) is an uncommon inflammatory disorder that may~     affect multiple organ systems, including the biliary tree. IgG4-sclerosing cholangitis~     (IgG4-SC) can be difficult to distinguish from primary sclerosing cholangitis (PSC) or~     cholangiocarcinoma (CCA). The investigators aim to evaluate the sensitivity and specificity~     of bile for the diagnosis of IgG4-SC. Bile samples of patients with biliary strictures of~     various causes, including IgG4-SC, PSC, and CCA, will be collected during clinical~     cholangiography procedures. IgG4 will be measured in bile specimens and bile IgG4~     concentrations compared between IgG4-SC, PSC, CCA, and other types of biliary strictures.~   "
72599|NCT02616692|"~     This non-interventional cross-sectional online survey will evaluate preferences among~     patients with self-reported HCC. The survey will ask patients to express their preferences~     regarding descriptions of HCC treatments, which will include sorafenib (which will be~     described as 'oral anti-cancer therapy'), repeated transarterial chemoembolization (TACE),~     and hepatic arterial infusion chemotherapy (HAIC). Please note that all interventions that~     patients may have received before completing this online survey were given regardless of~     their participation in this survey. Questions also include asking patients to rank various~     treatment characteristics (e.g., mechanism of action, risk of adverse effects, etc.) relative~     to each other. The ultimate goal is to better understand patient perceptions of these~     treatments and to provide evidence to help in patients' and physicians' treatment~     decision-making in HCC.~   "
72600|NCT02616679|"~     The current study aims to validate several novel cognitive tasks expected to be sensitive to~     brain impairment in specific anatomic regions affected in preclinical Alzheimer's~     disease(pAD). The tasks are validated in 60 cognitively and clinically normal participants~     ages 60 - 85, inclusive, against reasonably well-established biomarkers of Alzheimer's~     disease, including 1) simultaneous positron emission tomography (PET) [18F]Flutemetamol~     amyloid and CT imaging and 2) to the extent data is available from other studies,~     participants' brain MRI and cerebral spinal fluid (CSF) amyloid and tau.~   "
72601|NCT02616666|"~     A trial of patients with type 2 diabetes mellitus to evaluate the comparative effectiveness~     between dapagliflozin and Standard of Care (SOC)~   "
72602|NCT02616653|"~     This study is designed to determine the frequency of Tuffier's line overestimation (2 lumbar~     levels or more) when the palpation method is used in obese parturients at term in the lateral~     position compared to the sitting position.~      Hypothesis: The L3-L4 intervertebral space identified by the palpation method will be two~     levels higher than the level determined by ultrasonography (US) more often in the lateral~     than in the sitting position.~   "
72603|NCT02616640|"~     This is a multicenter, open-label, Phase 1b study to determine the recommended dose and~     regimen of durvalumab either as monotherapy or in combination with POM with or without low~     dose dex in subjects with RRMM. The study will consist of a dose-finding portion as well as a~     parallel dose-expansion portion to determine the optimal dose and regimen.~      On 05 Sep 2017, a Partial Clinical Hold was placed on this study by the United States (US)~     Food and Drug Administration (FDA). The decision by the FDA was based on data related to~     risks of anti-programmed cell death-1 (PD-1) antibody, pembrolizumab, in combination with~     IMiDs® immunomodulatory drugs in patients with multiple myeloma. As a result, enrollment into~     this study has been discontinued. Subjects who are receiving clinical benefit, based on the~     discretion of the investigator, may remain on study treatment after being reconsented.~   "
72604|NCT02616627|"~     Aims:~        1. To determine whether BMD and muscle mass were associated with fractures and other~          adverse events in dialysis patients.~        2. To explore the effects of the interactions among FGF23, calcium, phosphate, PTH and~          vitamin D on low bone mineral density and sacropenia in dialysis patients.~      Method:~      In this study, the investigators plan to use DXA to screen for BMD, relevant novel bone~     microstructure parameters, and body composition in chronic dialysis patients. Also, the~     investigators plan to use blood testing to measure the blood level of FGF23, calcium,~     phosphate, PTH and vitamin D. The investigators conduct a prospectively follow up program for~     these participants to evaluate clinical courses and outcomes. Patients will receive DXA~     (including BMD and body composition) tests and blood work at baseline and one-year. Muscle~     power and physical performance will be measured at baseline, 6 months and one-year.~   "
72605|NCT02616614|"~     Actavis has developed a generic formulation of clindamycin 1.2% and benzoyl peroxide 3.75%~     gel. This study is designed to evaluate the safety and efficacy of this formulation in~     subjects with Acne Vulgaris~   "
72606|NCT02616601|"~     This study is to evaluate the efficacy and safety of a generic formulation of fluorouracil~     0.5% cream against the brand product (Carac) in subjects with actinic keratoses~   "
72607|NCT02616588|"~     The overall goal of this study is to evaluate the feasibility of a veteran patient navigator~     and social work counseling intervention in veterans with advanced stage cancer at the Denver~     VA Medical Center. This is a tiered intervention: patients first receive the veteran patient~     navigator component of the intervention, and then if additional patient needs are present~     they receive the social work counseling component of the intervention. The overall~     intervention will help veterans communicate their care preferences with their providers.This~     is a study of behavioral and care strategy interventions and involves no investigational~     drugs or devices.~   "
72649|NCT02616042|"~     This study aims to evaluate the effect of dentifrice formulations containing Centella~     asiatica and bamboo salt on gingivitis and dental plaque. Participants uses dentifrice which~     contains Centella asiatica and bamboo salt and the same participants will also use placebo~     for tooth brushing by cross-over design.~   "
72608|NCT02616575|"~     Aims: The purposes of this study are~        1. to create a smart living environment with home care system using GPS and cloud-based~          services for elderly people.~        2. to improve the home care system from user feedback and recommendations.~      Methods: Participants (n = 50) will be recruited from geriatric clinics in National Taiwan~     University Hospital (NTUH) main hospital and its Beihu branch. Enrollment criteria include:~     aged 60 or older, living alone or with one companion (not children), taking at least one~     chronic medications, having the capability to understand the study and complete the study,~     willing to participate into the study with telephone follow ups.~   "
72609|NCT02616562|"~     This trial is conducted globally. The aim of the trial is to investigate efficacy and safety~     of once-weekly NNC0195-0092 (somapacitan) treatment compared to daily growth hormone~     treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children~     with growth hormone deficiency.~      The main trial period will consist of 26 weeks of treatment, followed by a 26 week extension~     period and a 104 weeks safety extension trial period.~   "
72610|NCT02616549|"~     The purpose of this study is to evaluate the efficacy of a multi-component yoga intervention~     featuring Sudarshan Kriya Yoga (SKY) as an adjunctive treatment for patients with Major~     Depressive Disorders with incomplete response to antidepressants.~   "
72611|NCT02616536|"~     Procedures:~      The study will be conducted in two phases:~      Phase 1~        -  Perception and Satisfaction questionnaire will be developed~        -  A validation test will be conducted on the Perception and Satisfaction questionnaire~          (face, content and construct) before conducting the study. The validation process will~          involve the participation of lecturers, professors and students by convenience sampling.~      Phase 2~        -  To prevent bias from the researchers, each participant will be given their code as their~          identification number. Then the participants will be randomly divided into two groups.~          They will be briefed on the purpose of study (stating that, the investigators would like~          to see the efficacy of various teaching methods on students' knowledge gain) and~          procedure of the study (examinations will be conducted, surveys at the end of each class~          session and at the end of the study). They are requested to fill up basic demographic~          data, consent form and ILS questionnaire(measuring the learning style of student) before~          beginning the study.~        -  In this study, the lecture will be given by the 'Researcher 1' to standardize the input~          to the participants of the two groups. This will produce a standardized input to the~          students of the two groups of teaching method.~        -  For the FC (flipped classroom) group, the length of the pre-recorded lecture videos will~          be the same which the participants can view it unlimitedly. An assignment will be given~          for FC group that will be attempted during the discussion class(2 hours) a week after~          with the lecturer. No grades will be given for the assignment.~        -  Meanwhile for the TC(traditional classroom) group, a standard lecture class of 1 hour~          and 1 hour of tutorial class will be conducted on the same topic. The same ungraded~          assignment will also be given to this group a week after the lecture class to be~          attempted in the tutorial class~        -  One day gap will be given following the discussion and tutorial class for FC and TC~          groups respectively following which an examination of 1 hour duration will be conducted~          to test on their level of knowledge (assessed by exam score) on the topic being taught~          for both the groups using the same set of questions.~        -  At the end of the study, each participant will be given a feedback questionnaire to~          evaluate their perception and satisfaction on the teaching method applied on them using~          the 'Perception and Satisfaction Questionnaire'.~   "
72612|NCT02616523|"~     Using combination of opioid analgesics and analgesics with different mechanism of action the~     investigators can decrease the consumption of opioid analgesics and their side effects. The~     investigators will use opioid analgesic fentanyl alone or in combination with dexmedetomidine~     or lidocaine.The participants scheduled for laparoscopic intestine resection will be divided~     in three groups: in the first group, the participants will receive single boluses of~     fentanyl, in the second group, the participants will receive continuous infusion of lidocaine~     and single boluses of fentanyl, and in the third group, the participants will receive~     continuous infusion of dexmedetomidine and single boluses of fentanyl. Participants with~     intraoperative infusion od dexmedetomidine or lidocaine will need less boluses of fentanyl~     during the operation and less opioid analgesics after the operation in comparison to those~     who will receive only fentanyl boluses. Better cognitive function after the operation is~     expected in participants receiving dexmedetomidine infusion. There will be minimal incidence~     of neuropathic pain because of minimal surgical injury of peripheral nerves in all groups of~     patients.~   "
72613|NCT02616510|"~     The polycystic ovary syndrome (PCOS) is the most common endocrinopathy amongst women of~     reproductive age. PCOS is associated with various cardiovascular risk factors such as~     obesity, glucose intolerance, dyslipidemia hypertension and the metabolic syndrome. Whether~     these increased cardiovascular risk factors result in the development of actual~     cardiovascular disease in later life remains to be established.~      Women with premature ovarian insufficiency (POI), experience menopause prior to the age of 40~     years. Women with POI may exhibit dyslipidemia. A young age at menopause has been previously~     associated with increased cardiovascular morbidity and mortality.~   "
72614|NCT02616497|"~     Investigation of the efficacy and safety of triflusal in comparison with aspirin in patients~     with stable coronary artery disease (CAD) and in those with a history of an acute~     non-cardioembolic ischemic stroke.~   "
72615|NCT02616484|"~     The objective of this research study is to conduct a pivotal phase 3 trial of treatment with~     the investigational drug dichloroacetate (DCA) in young children with deficiency of the~     pyruvate dehydrogenase complex (PDC). PDC deficiency (PDCD) is the most common cause of~     congenital lactic acidosis and is a frequently fatal metabolic disease of childhood for which~     no proven treatment exists. The investigators predict that DCA represents targeted potential~     therapy for PDCD because of its ability to increase both the catalytic activity and stability~     of the enzyme complex. The conclusions of numerous laboratory and clinical investigations are~     consistent with this postulate and have led to the designation of DCA as an Orphan Product~     for congenital lactic acidosis by the Food and Drug Administration.~      A novel Observer reported outcome (ObsRO) survey that is completed by study participant's~     parent/caregiver, is the efficacy outcome measure.~   "
72616|NCT02616471|"~     The overall aim of the present research project is to examine whether consumption of high~     daily amounts of cheese, both high-fat and low-fat, affects risk markers of disease in a~     study population of men and women with metabolic syndrome risk factors.~      It will be explored whether high-fat and/or low-fat cheese consumption can be regarded~     healthy to consume for at-risk populations (assessed by within-group comparisons from~     baseline values) and if low-fat or non-fat alternatives to high-fat cheese should continue to~     be recommended (assessed by between-group comparisons).~      In addition, it will be assessed if cheese consumption affects women and men differently as~     suggested by observational data. The present research project will examine the health effects~     of cheese as a food product per se and not as a sum of single nutrients, knowing that the~     single components of cheese cannot be adequately placebo-matched. A relatively high daily~     intake of high-fat cheese will be compared to a similar intake of low-fat cheese and with a~     carbohydrate control.~   "
72669|NCT02615782|"~     This study is a randomized, open-label, oral single dosing, two-way crossover clinical trial~     to evaluate the effects of food on the bioavailability of CKD-397 after a single oral dose in~     healthy male subjects~   "
72617|NCT02616458|"~     Importance: Ear pain is a frequent reason for pediatric visits. Objective: To determine if a~     program of anticipatory guidance counseling for ear pain at the 12-15 month routine~     preventive care visit in a predominantly low income population can reduce medical visits to~     clinic, emergency department (ED), and urgent care (UC).~      Design: Single blind randomized control trial of an ear pain counseling program.~      Setting: The Child Health Clinic (CHC), a primary care clinic at Children's Hospital~     Colorado, which serves a predominantly low income population with diverse cultural and ethnic~     backgrounds.~      Participants: 310 mothers were enrolled at their child's 12-15 month well child visit.~      Intervention: Structured 10-minute education intervention, given by a research assistant,~     used a slide presentation that reviewed ear pain Main Outcome and Measures: Number of ED, UC,~     and clinic visits for otitis media for the 12 month period after entry into the study and~     whether the visit included a prescription for antibiotics.~   "
72618|NCT02616445|"~     The purpose of this study is to determine whether the drug UE2343, a potential treatment for~     Alzheimer's Disease (AD), is effective by assessing safety, tolerability, pharmacokinetics~     and pharmacodynamics in a Multiple Ascending Dose Study. Protocol amendments to the study~     will examine any food effect and determine if the drug penetrates the Blood-Brain Barrier.~   "
72619|NCT02616432|"~     A randomized screening trial to compare the diagnostic accuracy of screening for breast~     cancer with three-dimensional digital breast tomosynthesis (DBT) plus two-dimensional~     full-field digital mammography (FFDM) versus FFDM alone.~   "
72620|NCT02616419|"~     Since the late 1980s, several studies focused on pediatric procedural pain and show that it~     still underevaluated and undertreated, especially in the Emergency Department (ED).~     Needle-related procedures are the most important source of pain and anxiety and children.~     Since it is impossible to completely eliminate the pain and anxiety experienced by children~     during painful procedures, use of non-pharmacological and/or pharmacological interventions~     might be beneficial. Most methods used for relief of procedural pain and anxiety for children~     require time or extra staff, which represent barriers to their implantation in the ED. An~     easy-to-use and rapid non-pharmacological intervention could overcome these constraints and~     optimize procedural pain and anxiety relief in children undergoing a needle-related~     procedure.~      The primary objective of this study is to determine if a device combining cold and vibration~     (Buzzy®) is non-inferior (no worse) than a topical anesthetic cream (lidocaine liposomal 4%)~     for procedural pain management in children undergoing needle-related procedures in the ED.~      Investigators strongly believe that the use of the Buzzy® device in the ED will improve~     significantly the pain and anxiety felt by children undergoing needle-related procedures.~     Since EDs are usually chaotic and very busy, an easy-to-use and rapid non-pharmacological~     intervention like the Buzzy®, will surely be adopted by the nursing personnel as a useful~     tool for procedural pain. Given this knowledge, the investigators feel that this randomized~     controlled trial will have the potential to improve nursing practice and optimize painful~     experiences of children undergoing needle-related procedures.~   "
72621|NCT02616406|"~     This is a study using wearable monitoring devices, patient activity and sleep patterns to~     monitor pre and post operative following outpatient inguinal hernia surgery to determine when~     these parameters return to baseline.~   "
72622|NCT02616393|"~     A study to assess the activity of tesevatinib in subjects with NSCLC and activating EGFR~     mutations who have disease progression with Brain Metastases (BM) or Leptomeningeal~     Metastases (LM) or who heave either BM or LM at initial presentation.~   "
72623|NCT02616380|"~     The study is designed as a prospective, observational study to assess the effect of~     adalimumab on health-related quality of life (QoL) and work productivity in patients with~     rheumatoid arthritis (RA) in Taiwan.~   "
72624|NCT02616367|"~     This is a randomized prospective outcomes study comparing two groups of patients. One group~     will receive liposomal bupivacaine for a periarticular injection. The other will receive~     ropivacaine for periarticular injection for pain relief after Total Knee Arthroplasty. the~     primary objective of this study is to determine if liposomal bupivacaine provides superior~     pain control (decreased maximal pain scores within the first 72 hours post surgery) when~     compared to ropivacaine when injected in a periarticular injection.~   "
72625|NCT02616354|"~     Explore Imipenem/Cilastatin two-step dosing compared to 2 hours infusion in patients with~     severe whether can obtain better results of the pharmacokinetic/pharmacodynamic, for clinical~     rational use of antimicrobial agents, and provide theoretical support for optimizing dosage~     regimen.~   "
72626|NCT02616341|"~     The overall aim of this study is to determine modifications to Exposure and Response~     Prevention (ERP) therapy that are needed in order to effectively deliver treatment for~     Obsessive Compulsive Disorder (OCD) in a community mental health center. This study is the~     final study in a series of three projects executed to adapt and pilot-test a team ERP (T-ERP)~     intervention that will optimize therapist time by utilizing paraprofessionals to assist with~     group-ERP treatment plans. The intervention will be tailored to meet the unique needs of~     low-SES individuals with OCD and be implemented in a community mental health center (CMHC).~   "
72627|NCT02616328|"~     This is a single-arm, open-label, non-randomized, multicenter trial to evaluate the efficacy~     and safety of using tocilizumab for confirmed rheumatoid arthritis participants in clinical~     practice.~   "
72628|NCT02616315|"~     The purpose of this study is to determine the effect of naltrexone hydrochloride(HCL) and~     bupropion hydrochloride extended release combination (NB) compared with placebo on weight~     loss in obese participants post bariatric surgery.~   "
72629|NCT02616302|"~     The purpose of this study is to assess the safety and effectiveness of treatment with once~     daily (QD) oral administration of dexlansoprazole capsules (15, 30, and 60 mg) in pediatric~     participants aged 1 to 11 years with symptomatic nonerosive gastroesophageal reflux disease~     (GERD).~   "
72630|NCT02616289|"~     The investigators hypothesize that the absorption of topically applied EFA-containing~     emollient (SSO) into the skin and thence into the bloodstream in children with SAM will~     improve skin barrier function and accelerate weight gain and clinical rehabilitation beyond~     that possible through normal standard-of-care~   "
72670|NCT02615769|"~     The purpose of this study is to investigate if focused information of spirometry in the~     invitation to preventive health checks will increase the attendance compared with a standard~     invitation to preventive health checks.~   "
72631|NCT02616276|"~     This is a crossover clinical trial aimed at adults (aged 20-40 years, with no cardiovascular~     disease), selected by consecutive sampling at urban primary care health clinics in Salamanca~     (Spain). Each subject will complete three interventions, with a washout period of one week:~     control breakfast (water), low glycemic index breakfast (apple, yogurt, walnuts and black~     chocolate) and high glycemic index breakfast (grape juice, bread and strawberry jam). The~     postprandial effect will be assessed at 60 and 120 minutes from each breakfast, measuring~     blood glucose and insulin and cognitive performance. Measurements will be performed of~     central blood pressure, augmentation index, pulse wave velocity, cardiac output and total~     peripheral vascular resistance at minutes (-10, 0, +15, +30, +45, +60, +75, +90, +105 and~     +120).~   "
72632|NCT02616263|"~     The purpose of this research study is to determine the relationships between foot muscle,~     foot motion, and toe deformity. Results from this investigation will help the investigators~     to understand what contributes to foot deformities and the role of the foot muscles in the~     development of foot deformities. This could potentially guide treatment options focusing on~     strengthening the foot muscles to prevent or reduce the risk of developing a foot deformity.~   "
72633|NCT02616250|"~     The main objective of this study is to evaluate the efficacy of Ivermectin 1% cream (IVM)~     associated with Brimonidine 0.33% gel (Br) compared with the association of their respective~     vehicles in the treatment of moderate to severe rosacea.~   "
72634|NCT02616237|"~     The purpose of this study is to determine the feasibility and efficacy of a 6-month weight~     loss intervention program for obese working adults through a popular social networking site -~     Facebook.~   "
72635|NCT02616224|"~     This observational disease registry is a prospective, national, non-interventional study~     designed to enroll participants who have received an initial diagnosis of unresectable,~     locally advanced (LA) or metastatic breast cancer (mBC), up to 6 months prior to registry~     enrolment. These participants will be prospectively followed for at least 5 years after study~     enrolment to evaluate their anti-cancer treatments. Data on participants' previous~     anti-cancer treatments for breast cancer will be collected retrospectively at study entry.~   "
72636|NCT02616211|"~     Patients are asked to participate in this study if they have been diagnosed with a thoracic~     carcinoma which includes lung cancer and have a gene mutation (alteration in the body's~     genetic instructions) and after undergoing treatment the cancer has come back, progressed, or~     shown a partial response on standard treatment.~   "
72637|NCT02616198|"~     The aim of this study was to evaluate the long-term clinical performance of two highly~     viscous encapsulated GICs (EquiaFil and Riva SC) covered with two different coatings (Equia~     Coat and Fuji Varnish) over 6-year using modified United State Public Health Service (USPHS)~     criteria.~      A total of 256 restorations were made with EquiaFil and Riva SC. Equia Coat or Fuji Varnish~     was used randomly on the surface of the restorations. The restorations were evaluated at~     baseline, 6, 12, 18 months and 6 years after placement using modified USPHS criteria. The~     results were evaluated with Pearson Chi-Square and Mann Whitney U-test (p< 0.05).~   "
72638|NCT02616185|"~     The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses~     of a vaccine-based immunotherapy regimen for patients with prostate cancer.~   "
72639|NCT02616172|"~     Autologous human bone marrow mononuclear fraction (BMMF) will be harvested and given to~     children with bilateral moderate to severe sensorineural hearing loss. The aim is to~     determine if bone marrow mononuclear fraction (BMMF) infusion is safe, feasible, improves~     inner ear function, audition, and language development.~   "
72640|NCT02616159|"~     The objectives of this study are to compare the glycemic and insulinemic responses over 3~     hours elicited by 3 oatmeal varieties compared to each other and to controls of ready to eat~     and hot cereals.~   "
72641|NCT02616146|"~     The purpose of this study is to assess the contraceptive efficacy of the ENG-E2 vaginal ring~     in women between 18 and 35 years of age based on the number of in-treatment pregnancies as~     expressed by the Pearl Index (PI). The study will also assess the safety and tolerability of~     ENG-E2 vaginal ring. The levonorgestrel-ethinyl estradiol (LNG-EE) 150/30 μg combined oral~     contraceptive (COC) will be used as the active comparator.~   "
72642|NCT02616133|"~     Currently many patients with HER2+ Breast Cancer do not have the opportunity to be evaluated~     by a medical oncologist for neo-adjuvant treatment due to the current lack of care~     coordination between the surgeon/surgical oncologist and the medical oncologists.~      This project will evaluate the feasibility to enhance knowledge that drives adoption of~     evidence based care, and evaluate the improvement in care coordination between oncologists~     and surgeons for patients with HER2+ Breast Cancer in the Neo-Adjuvant setting.~   "
72643|NCT02616120|"~     The purpose of this study is to examine the efficacy and safety of SQJZ Herbal Mixtures on~     non-motor symptoms of PD patients.~   "
72644|NCT02616107|"~     The purpose of this two-year mixed methods study is to develop and test an intervention to~     improve cancer family caregivers' knowledge of care options (curative, palliative, and~     hospice care) and goals of care communication as part of a self-management (SM) training~     program.~      The two specific aims of this project are to:~        1. Develop a psycho-educational intervention called Managing Cancer Care: A Caregiver's~          Guide (MCC-CG), for family caregivers of patients with breast cancer to increase~          knowledge of care options, goals of care communication, and other SM skills.~        2. Evaluate the feasibility and preliminary efficacy of the MCC-CG in a pilot randomized~          controlled trial compared with an attention-control condition (symptom management~          education) on knowledge of care options, goals of care communication, and other key SM~          skills (engagement in SM, management of transitions and uncertainty, increasing~          self-efficacy, appropriate use of health care resources).~   "
72645|NCT02616094|"~     Extending previous findings, and applying a novel multi-method translational approach, this~     project hypothesizes that there are alcohol-related neuroendocrine and neural changes~     observable in acute and protracted abstinence, and which can accurately classify future~     relapse and treatment outcome in separate alcohol dependent (AD) patient samples, thereby~     validating them as biomarkers of relapse, with potential clinical utility as prognostic~     markers in identifying and treating those most susceptible to relapse.~   "
72646|NCT02616081|"~     The investigators goal is to create a better understanding of patient reported outcomes for~     bladder management strategies (clean intermittent catheterization (CIC), indwelling catheter~     (IDC) and bladder surgery.~   "
72650|NCT02616029|"~     This study will evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir~     alafenamide (E/C/F/TAF) fixed dose combination (FDC) after switching from a stable regimen~     consisting of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine~     (ABC/3TC) plus a third antiretroviral agent in participants harboring the archived~     nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) resistance mutation M184V and/or~     M184I in HIV-1 reverse transcriptase.~   "
72651|NCT02616016|"~     The Philips Sonalleve MR-HIFU system is expected to be effective in reducing pain intensity~     and/or reducing analgesic use in patients with painful uncomplicated bone metastases. No~     serious adverse effects are expected to result from this treatment.~   "
72652|NCT02616003|"~     The frequency of patients with a BMI above 70 kg/m2 who need immediate weight loss surgery is~     risen continuously. For those patients a prior-to-surgery conditioning therapy is mandatory~     to gain technical and physical operability. The exclusively well-established preliminary~     therapy so far was the intragastric balloon, which takes 7 months of treatment time. Due to~     life-threatening conditions of giant obese patients, who have been admitted to hospital, the~     investigators were forced to develop a more prompt acting conditioning therapy to bring those~     individuals in a short run to an improved and fit-for-surgery state. In such an impasse the~     investigators combine Liraglutide with its well-known weight-loss effect with a leucine-based~     amino acid infusion that is generally used for patients with liver insufficiency, in~     expectance of an additional weight loss and liver reduction effect.~   "
72653|NCT02615990|"~     This study will assess the effects of the Erigo applied as part of the early mobilization~     program in the Trauma ICU at the University of Kentucky. It is our hypothesis, that with the~     Erigo, critically ill patients will tolerate verticalization and mobilization earlier and~     safely resulting in improved outcomes measured by increased mobility and strength on ICU~     discharge, decreased requirements for mechanical ventilation, reduced complication rates and~     decreased ICU and hospital LOS.~   "
72654|NCT02615977|"~     The investigators will examine clinical alterations in learning and automated approach~     behaviour and their neurobiological correlates in alcohol-dependent patients and healthy~     social drinkers and assess whether they are affected by a Zooming Joystick Training (ZJT;~     randomized verum versus placebo training) which trains subjects to habitually push~     alcohol pictures away.~      The investigators will test whether activations following treatment predict relapse rate~     (primary outcome measure) and the prospective amount of alcohol intake (secondary outcome~     measure) within a six-month follow-up period.~      Using fMRI, the investigators will use the Pavlovian-to-Instrumental-Transfer (PIT) paradigm~     established during the first funding period to distinguish the effects of appetitive,~     aversive, and drug-related Pavlovian cues on automated instrumental approach behaviour and to~     assess ZJT training effects comparing functional activation before and after ZJT training.~      The investigators will also scan subjects during performance of a short standard working~     memory task. Behaviourally, aspects of impulsivity will be assessed with the Value-Based~     Decision Making (VBDM) Battery. Scanning will be repeated after ZJT training to assess its~     effects on the neural correlates of Pavlovian-to-Instrumental transfer (PIT).~   "
72655|NCT02615964|"~     Patients presenting to UIC rheumatology clinic with Raynaud's disorder and scleroderma will~     be asked to participate. 10 hands of patients with both Raynaud's disorder and scleroderma~     will be studied. This research study is being done to better understand Raynaud's disease and~     to assess the role of blood flow measurement in diagnosing the disorder, specifically,~     through data collected by an MRI procedure called NOVA FLOW. NOVA is a blood flow measurement~     software system owned by the study's sponsor, VasSol, Inc.~   "
72656|NCT02615951|"~     Recently, it has been shown that B cells could also have regulatory functions through the~     secretion of interleukin 10 (IL-10). They are called the B regulatory cells (Breg). In the~     mouse model the most commonly used of rheumatoid arthritis, collagen-induced arthritis (CIA),~     the transfer Breg helps prevent the development of CIA and cure established arthritis. The~     investigators have recently shown that Breg were decreased in patients with RA compared to~     controls and that the rate of Breg was inversely correlated with disease activity and~     autoantibody. These results thus suggest that the lack of IL-10 secretion by B cells plays an~     important role in the pathophysiology of RA. Nevertheless, in humans, the Breg remain poorly~     understood. The main objective of this project is to better characterize the B capable of~     producing IL-10 both in subjects with RA and controls. Understanding which induces the~     secretion of IL-10 by B could allow to consider new therapeutic approaches in autoimmune~     diseases, including in RA.~      The investigators therefore aim to identify nutrient transporters, chemokine receptors, genes~     and surface proteins differentially expressed between Breg and other B cells in patients with~     RA and in controls.~   "
72657|NCT02615938|"~     This is an exploratory Phase 2a, randomized, double-blind, placebo-controlled,~     parallel-group, multinational study investigating the initiation or withdrawal of~     hydroxychloroquine in subjects with chILD.~   "
72658|NCT02615925|"~     Provide a description of patients admitted in the psychaitric department of the Mayotte~     Hospital~   "
72659|NCT02615912|"~     The purpose of this study is to understand the changes in skin microflora, skin barrier~     function, and skin biochemical constituents in response to direct contact with model~     surfactants used in personal care articles. The results from this study will provide insights~     into the complex interaction between the skin microbiome and the epidermis after exposure to~     surfactants.~   "
72671|NCT02615756|"~     In this study, we use positron emission tomography (PET) and functional magnetic resonance~     imaging (fMRI) to study brain mechanisms that contribute to physical exercise-induced reward.~     We examine whether acute physical exercise releases endogenous opioids in the brain, and~     whether it modulates brain responses to viewing appetizing foods. Unraveling these mechanism~     are instrumental from a public health perspective, given the undisputed positive health~     effects of physical exercise.~   "
72717|NCT02615145|"~     The interferon-free combination regimen of Paritaprevir/r - Ombitasvir with or without~     Dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC)~     has been shown to be safe and effective in randomized controlled clinical trials with strict~     inclusion and exclusion criteria under well controlled conditions.~      This observational study is the first effectiveness research examining the ABBVIE REGIMEN ±~     RBV, used according to local label, under real world conditions in Germany in a clinical~     practice patient population.~   "
72660|NCT02615899|"~     Background Balance impairment is a key factor contributing to falls in older adults.~     Conceptually, clinicians may be able to prescribe targeted exercises if specific impairments~     can be identified. Objective Our objective was to use a model of balance subsystems to~     identify balance impairments and demonstrate the effectiveness of targeted (matched)~     exercises to improve balance and reduce fall risk in community-dwelling older adults. The~     investigators used the Balance Evaluation System Test (BESTest) as the model because it~     categorizes balance into 6 subsystems. Design Randomized, partially blinded,~     pretest-post-test clinical trial consisting of 2 Phases: 1. A comparison between~     impairment-matched exercises and a control, and 2. A comparison between impairment-matched~     and mismatched exercises. Setting Senior independent living community. Participants Adult~     volunteers (n = 40; aged 74-94) recruited as sample of convenience who met the criteria.~     Participants (n = 20) identified with impairment in the biomechanical (BC) constraints~     subsystem and participants (n = 20) with impairment in anticipatory postural adjustment (APA)~     subsystem were enrolled and randomized into 2 subgroups (matched and control/delayed~     mismatched; n = 10 each subgroup). Intervention Phase 1: Participants in the matched subgroup~     received a 6-week exercise program matched to their impaired subsystem while the mismatched~     subgroup served as control. Phase 2: Following the delay, participants in the mismatched~     group received a 6-week exercise program mismatched to their impairment. Measurements Primary~     outcome variables were scores on the targeted subsystem (BC, APA), BESTest total, Berg~     Balance Scale, and fear of falling measure. Quality of life was a secondary outcome. Outcome~     data were collected by the tester blind to pretest scores and group allocation. Results The~     matched exercise subgroups demonstrated both statistical and clinical improvement in all~     outcome variables compared to the control; and showed greater improvement in balance~     impairments compared to the mismatched subgroup, but not in fall risk reduction. Limitations~     The therapist who administered the pretest knew the subgroup assignment and implemented the~     exercises. Conclusions Results provide preliminary evidence that using a balance assessment~     model to identify impairments in the BC and APA subsystems and prescribing targeted exercises~     reduces these balance impairments for older adults and may warrant future studies.~   "
72661|NCT02615886|"~     The purpose is to assess feasibility of rice bran consumption in weaning children and collect~     pilot data on gut microbiome and metabolome modulation with rice bran intake for diarrheal~     prevention.~   "
72662|NCT02615873|"~     The purpose of this study is to allow evaluation of long-term clinical effect and safety~     outcome of treatment with AP-CD/LD, as well as to allow patients to benefit from extended~     treatment duration with AP-CD/LD after they have successfully completed the Phase 3 core~     study IN 11 004 ('core study', a phase III, multicenter, randomized, double-blind,~     double-dummy, active-controlled Phase 3 study to assess the safety and efficacy of AP CD/LD~     versus IR CD/LD in fluctuating PD patients).~   "
72663|NCT02615860|"~     Comparative evaluation of efficacy and safety of high-resolution anoscopy (HRA)-guided~     topical treatment (trichloroacetic acid, TCA) vs. surgical treatment (electrocautery, ECA) in~     HIV-positive patients for human papillomavirus (HPV)- induced AIN, an anal cancer precursor.~     The primary hypothesis is that cost-saving and simple TCA treatment is non-inferior to the~     current best option therapy with ECA. TCA treatment would also be possible in the normal~     setting of a doctor´s office without extensive specialization and without complex technical~     equipment.~   "
72664|NCT02615847|"~     Symptomatic sickle cell disease is worldwide the most frequent cause for hereditary hemolytic~     anemia with recurrent pain crisis. Hemolysis, vaso- occlusive and pain crises are hallmarks~     of this disease and are causative for an important socio-economic burden worldwide,~     especially in Africa.~      Aside from allogenic stem cell transplantation, which is rarely available and very expensive,~     at present there is no curative treatment for patients with sickle cell disease (SCD). The~     current standard of care includes treatment with hydroxycarbamide and symptomatic care such~     as transfusions, antibiotic/analgesic treatment.~      This study has the aim to study the safety and tolerability of Memantin in patients with~     sickle cell disease.~   "
72665|NCT02615834|"~     We previously showed that a gentle chest pressure technique could be used on children over a~     year old to generate around 20% of the volume of air inhaled or exhaled in a single normal~     breath (also known as tidal volume). This showed that a non-invasive method could be used to~     provide a temporary means of artificial breathing, meaning that invasive procedures, such as~     putting in a breathing tube, could be avoided. What our results did not tell us, however, is~     how much oxygen can get to peripheral tissues (e.g., arms, legs) with this method. In this~     study, we want to compare two groups of children. All children will have a breathing tube;~     one group will have gentle chest pressure performed on them to see if oxygen saturations can~     be maintained above 90%. The other group will receive no chest pressure. We will see how long~     it takes for oxygen levels in both groups to drop to 90%, at which point, the patient will be~     ventilated mechanically.~   "
72666|NCT02615821|"~     Given the numerous physical and psychological benefits of engaging in regular physical~     activity (Biddle & Ekkekakis, 2005; Warburton et al., 2007) and the decrease in students'~     physical activity levels during the transition from high school to university (Bray & Born,~     2010) it is important for researchers to develop time-and-cost-effective interventions to~     prevent this drop in physical activity. Intervention research shows mental contrasting (a~     goal setting strategy) can be taught in a cost-and-time-effective way in order to increase~     physical activity (Oettingen, 2012). Researchers have also found that individuals who~     consider the emotional effects of physical activity are more likely to be physically active~     than those who consider the health-related effects (Rhodes et al., 2009). The purpose of this~     research is to combine these two approaches to develop and evaluate a novel mental~     contrasting intervention to increase physical activity among a sample of undergraduate~     students.~   "
72667|NCT02615808|"~     Hospitalized children with respiratory disease are commonly monitored with continuous pulse~     oximetry and heart rate-respiratory rate monitors. These data streams generate >4,000 unique~     data points each patient-day, yet only a tiny fraction are used to inform care decisions.~     Failure to adequately summarize this large amount of data for clinicians may result in~     suboptimal care because clinicians may miss important data signals and may under- or~     over-react to individual data points. In children hospitalized with respiratory disease and~     in need of supplemental oxygen, there are a number of care decisions, currently made without~     adequate data, which could be informed by intelligent data visualization tools. This study~     has employed user-centered design to develop data displays that inform nurses' and~     respiratory therapists' decision-making in supplemental oxygen delivery. The investigators~     are now evaluating the effectiveness of these displays in the clinical care of patients with~     two common respiratory conditions—infants with bronchiolitis admitted to the general~     pediatrics ward and preterm infants requiring supplemental oxygen who are cared for in the~     neonatal intensive care unit. By reducing patient's time on supplemental oxygen and improving~     time with optimal oxygen saturations, this work has the potential to lead to a breakthrough~     innovation that improves both outcomes and value.~   "
72668|NCT02615795|"~     The aim of this study is to evaluate the effect of monitoring patients with chronic~     obstructive pulmonary disease (COPD) after a hospitalization for COPD exacerbation or~     pneumonia. The patients are randomized to receive either standard treatment and follow up, or~     standard treatment and follow up, plus tele monitoring of key clinical parameters and~     symptoms for six months.~   "
72672|NCT02615743|"~     This study sets out to assess whether daily text message reminders help to enhance the~     consistency of use of controller medications following hospitalization for pediatric asthma~     patients ages 4-11 and their families. Text message reminders will be delivered to a~     subject's cell phone for those in the intervention group and electronic monitors will placed~     on the controller inhalers at the time of hospital discharge to track medication use over~     time in both the intervention and the regular care group. Families will complete surveys on~     the day of enrollment (in person), day 30 (telephone) and day 60 (telephone) on aspects of~     asthma care including asthma knowledge, medication routines, who is responsible for asthma~     care, and medication beliefs.~   "
72673|NCT02615730|"~     This is a Phase Ib/IIa, open-label, non-randomized, dose-escalation, multi-center study to~     evaluate the safety, tolerability, pharmacokinetics (PK), and clinical activity of oral~     GSK2636771 in combination with intravenous (IV) paclitaxel in two independent subject~     populations: subjects with PTEN-deficient, advanced gastric adenocarcinoma. This study will~     be conducted in two phases: the Dose Escalation Phase and the Dose Expansion Phase. The Dose~     Escalation Phase (Phase Ib) is designed to determine the maximum tolerated dose (MTD) and the~     recommended Phase II dose (RP2D) of GSK2636771 administered in combination with paclitaxel.~     The Dose Expansion Phase (Phase IIa) will further evaluate the safety and clinical activity~     of the RP2D as determined in the Dose Escalation Phase.~   "
72674|NCT02615717|"~     Threat-related attentional biases have been identified as a possible precursor to the onset~     and maintenance of posttraumatic stress disorder (PTSD). As a result, protocols such as~     Attention Bias Modification (ABM) have been developed and utilized to treat these attentional~     biases in adults diagnosed with PTSD. However, to-date, ABM protocols have not been examined~     for use specifically among victims of sexual assaults. Participants are 20 undergraduate~     women enrolled in a Midwest university. The efficacy of ABM in this population will be~     assessed, as will the relationship between ABM and PTSD symptom clusters and outcome~     variables such as anxiety and depression scores.~   "
72675|NCT02615704|"~     An electronic device application (APP) Mein Herz und ich has been developed specifically~     for acute coronary syndrome (ACS) patients who are prescribed to Brilique (ticagrelor) to~     increase adherence to treatment (medication and lifestyle changes) by a combination of~     reminders on medication intake, information on the importance of treatment, motivation by~     supportive messages, and visualisation of individual lifestyle choices' effect on~     cardiovascular risk. The aim of this study is to evaluate the effectiveness of this patient~     support tool~   "
72676|NCT02615691|"~     The purpose of this study is to investigate safety, immunogenicity and hemostatic efficacy of~     PEGylated recombinant FVIII (BAX 855) in previously untreated patients (PUPs) < 6 years of~     age with severe hemophilia A (baseline FVIII level < 1%) and < 3 EDs to ADVATE, BAX 855 or~     plasma transfusion.~   "
72677|NCT02615678|"~     The aim of this study is to collect preliminary data on the effectiveness of acupuncture for~     the treatment of CIPN in breast cancer patients.~   "
72678|NCT02615665|"~     The long-term outcome of patients resected for colorectal liver metastases (CLM) after~     neoadjuvant chemotherapy (CHT) depends by several tumoral and non-tumoral factors, such as~     the immune response to the tumor and to the CHT. The aim of this study was to investigate the~     impact of the pathological and immunological response in patients undergoing liver resection~     for CLM after CHT in regards to the long-term outcome.~   "
72679|NCT02615652|"~     Researchers of the three collaborating universities implement a pilot observational study in~     Gilgel Gibe Field Research Center, a health and demographic surveillance system run by the~     Jimma University, Ethiopia. In this setting, the investigators plan to study risk factors in~     young men for the development of common mental disorders and psychotic symptoms and the~     stability of distinct symptoms of mental disorders in the community. The investigators will~     explore in particular the impact of lifestyle on mental health in young men, including the~     traditional habit of chewing khat leaves, which contain amphetamine-like cathinone.~     Furthermore, the investigators want to demonstrate the reliability and validity of~     assessments performed by trained local interviewers.~   "
72680|NCT02615639|"~     The anti-virus effects is not satisfying in some of Chronic Hepatitis B（CHB) patients who~     have been on anti-Hepatitis B Virus (HBV) drugs therapy. Dendritic cell (DC) is critical in~     Hepatitis B Virus (HBV) specific immunity in the process of producing HBV promoter specific~     cytotoxic T cells (CTLs) and specific T helper cells (HTLs), however they are defective in~     CHB patients. Therefore, if it were going to remove HBV completely, it mainly depends if the~     body itself can produce enough HBV specific cytotoxic T cells (CTLs) and specific T helper~     cells (HTLs). Our research is to plus Hepatitis B Vaccine Activated-DCs therapy to CHB~     patients who have been on anti-HBV drugs but with poor effects, supposing to significantly~     improve anti-HBV efficacy, even to clean HBV from the patients.~   "
72681|NCT02615626|"~     The purpose of this study was to evaluate visfatin levels in different stages of periodontal~     diseases and health, moreover the effect of non-surgical periodontal therapy on visfatin~     levels in Gingival Crevicular Fluid (GCF) and Serum.~   "
72682|NCT02615613|"~     30-40 healthy male subjects with a BMI between 18.5 and 24.9 kg/m2 will be tested for food~     preferences using a questionnaire with 141 different foods. Accordingly, a high~     acceptability/palatability food will be selected (average score of ≥ 7 on the 9-point hedonic~     scale). Two versions of the selected high palatability food will be devised by modifying it~     to yield the original high and the modified low acceptability versions. The two versions will~     differ only in palatability and will be equicaloric. Subjects who agree on the acceptability~     of the two versions of the food (11 subjects) will consume, at fasting, the two versions of~     the food in a cross over design over two sessions. Each session will include an acceptability~     test, using the 9-point hedonic scale, on three instances: after sampling a spoonful, eating~     the whole portion and after 240 min. The quantity consumed on each session will constitute~     30% of the subject's resting energy expenditure. Moreover, fasting and postprandial hunger~     ratings and blood samples will be collected at time 0 and after 15, 30, 60, 120, 180 and 240~     min of the food/meal's ingestion. The visual analogue scale will be used for huger ratings.~   "
72683|NCT02615600|"~     Stimulation of the left and right auditory cortex with daily low-frequency transcranial~     random noise stimulation (tRNS) is used to modulate the neural pathways involved in chronic~     tinnitus.~   "
72699|NCT02615379|"~     EPIFLO® unit along with standard wound care vs only standard wound care for Surgical site~     infections (SSI).~   "
72684|NCT02615587|"~     The overall goal of this retrospective registry study is to investigate the burden-of.illness~     in atrial fibrillation (AF) in Denmark. Several Danish registries will be utilized to collect~     information on the diseases epidemiology including incidence and prevalence of AF and stroke~     as well as a stroke risk stratification of the Danish AF-population, the clinical and~     economical burden (in terms of direct and indirect cost) of AF and stroke to Danish patients,~     healthcare providers / healthcare system and society as well as describing treatment patterns~     with anticoagulant agents and their consequences in terms of stroke, bleeds, death and~     according cost in a real-life setting.~   "
72685|NCT02615574|"~     The investigators hypothesize that the treatment of metastatic colorectal cancer (mCRC)~     patients with the combination of alpha-type-1-polarized dendritic cell (αDC1) vaccines and~     tumor-selective chemokine modulation (CKM) will promote the infiltration of~     vaccination-induced CD8+ CTLs to tumor lesions and subsequently tumor regression with~     improved patient survival.~   "
72686|NCT02615561|"~     1. Curing mild atopic dermatis in children with a commerical medical device (Bepanthen Itch~          Relief Cream).~        2. Maintaining healthy skin by using a new cosmetic Bepanthen product or a commercially~          available cosmetic product~   "
72687|NCT02615548|"~     Physical activity is a key intervention used to reduce the healthcare costs and the negative~     consequences of Parkinson Disease (PD) by improving walking and balance and reducing the~     number of falls. However, not all exercise classes provide the same results for people with~     PD. Specific exercises designed to target the features of PD have shown greater outcomes than~     generic physical activity. The exercise principles include high-intensity (size and speed)~     movement, task repetition, rhythmical rocking, mental imagery, cognitive strategies,~     treadmill walking, and making use of internal and external cues. Collectively these~     PD-specific exercises can be designed to be run in exercise groups. Structured exercise~     groups also include social interaction that is known to improve depression and apathy, both~     of which are features common in people with PD.~      This study will compare the effect of specific, long-term community-based exercise class on~     balance, walking, quality of life, and mood compare to self-directed exercise.~      Investigators anticipate that participants from the community-based, long-term intervention~     will show better improvements in balance and walking compare to participants that are~     self-directing their activities.~   "
72688|NCT02615535|"~     Spaulding Rehabilitation Hospital is conducting a research study evaluating the effectiveness~     of the brain-training product, MUSE, an EEG-guided neurofeedback device designed to assist in~     cultivating a relaxed, attentive state of mind during meditation. The investigators study~     aims to evaluate whether such a tool could be useful in treating persistent traumatic brain~     injury symptoms such as inattention, impulsivity, irritability, or dysregulated mood.~   "
72689|NCT02615522|"~     Prospective, monocenter post market clinical follow-up of a primary knee replacement bearing~     the CE-mark.~      200 subjects will be recruited and followed up for up to ten years or until revision of the~     primary knee endoprosthesis, whichever occurs first. Documentation of clinical and~     radiological parameters within the clinical routine pre-operative and post-operative at 3 and~     12 months and 2, 5 and 10 years to evaluate time to revision, pain situation, knee~     functionality, mobility and stability.~   "
72690|NCT02615496|"~     The study will be an observational, cross-sectional study of knowledge, understanding, and~     self-reported behavior among a sample of physicians and patients with recent aflibercept~     experience in a total of up to five European countries.~   "
72691|NCT02615483|"~     The purpose of the present study is to investigate the effect of a Web- based Platform (WP)~     on anxiety and depression and health economics among patients undergoing lumbar spine fusion~     (LSF).~   "
72692|NCT02615470|"~     The study's aim is to enhance current immunization activities in community pharmacies through~     targeting the two most commonly available non-seasonal vaccines in community pharmacies,~     namely pneumococcal and herpes zoster vaccination services. The study will compare the change~     in the number of pneumococcal and herpes zoster vaccinations administered in pharmacy from~     the corresponding 6-month period prior to the intervention to the 6-month intervention period~     between intervention pharmacies and the control pharmacies.~   "
72693|NCT02615457|"~     RATIONALE:~      Huaier (Trametes robiniophila Murr) is a traditional Chinese medicine, which has been widely~     used in China for many years. The investigators previous study has reported that Huaier could~     exert great inhibitory effects on breast cancer cells both in vitro and in vivo.~      PURPOSE:~      To evaluate the efficacy and safety of Huaier Granule in treating women who have triple~     negative breast cancer that has been surgically removed.~   "
72694|NCT02615444|"~     The purpose of this study is to determine whether daily consumption of soluble fibre, oat~     beta glucan (4g), for six weeks will have any impact on overweight/obese individuals in terms~     of risk factors used to define metabolic disease.~   "
72695|NCT02615431|"~     The aim of the present study is to influence the central and obstructive sleep apnoea in~     patients with severe mitral insufficiency by an interventional MitraClip examination to~     evaluate.~   "
72696|NCT02615418|"~     This trial is designed to preliminary evaluate the efficacy and safety of NIBS system for~     treatment of chronic low back pain (CLBP) (over 6 months). The trial is of a double blind~     sham controlled partial crossover design and will involve 2 weekly treatments and evaluations~     for 6 weeks, with 6 weeks follow-up. The goal of the study is to 1. Asses the CLBP change~     immediate and long term effect for the trial duration and follow-up. 2. Asses quality of life~     improvement as measure by sleep quality and questioners. 3. Asses long term neuronal changes~     or lack thereof in treated and untreated subjects.~   "
72697|NCT02615405|"~     With the dissatisfaction of monoamine-based pharmacotherapy and the high comorbidity of~     physical illness in depression, the serotonin hypothesis seems to fail in approaching the~     etiology of depression. Based upon the evidence from epidemiological data, case-control~     studies of PUFAs compositions, and antidepressant effects in clinical trials, phospholipid~     polyunsaturated fatty acids (PUFAs) is enlightening a promising path to discover the unsolved~     of depression.~   "
72698|NCT02615392|"~     The purpose of this study is to test the effectiveness of prescribing park use (i.e., ''Park~     Prescription'') to insufficiently active individuals. It is hypothesized that Park~     Prescription will motivate the target population to increase physical activity and thereby~     improve their physical and mental health.~   "
72700|NCT02615366|"~     Bleeding is an important consideration in breast surgeries that involve large resections of~     soft tissues in the breast. Inappropriate bleeding during or after surgery, can lead to~     uncomfortable fluid buildup in the breasts known as a hematoma or seroma, which may require~     additional procedures or reoperation. Patients may experience a great deal of discomfort and~     additional costs as a result; additional hospital time and procedures also burdens health~     care spending. Tranexamic acid (TXA) is commonly used drug in many medical settings to reduce~     excessive bleeding; however, no such drug is standard practice in breast surgery. The aim of~     this study is to determine if TXA is superior to placebo in reducing the bleeding~     complications in breast surgeries, including reduction mammaplasty, mastectomy with and~     without immediate tissue expander and implant-based reconstruction, and oncoplastic breast~     surgery. This study is a randomized, double-blind, placebo-controlled trial. Patients~     undergoing these procedures will be randomly allocated to receive either TXA or placebo.~     Patients will be placed on a drug/placebo regimen of 3 doses/day for 6 days starting on the~     day of their surgery. The primary outcome is the incidence of hematoma and/or seroma~     formation following breast surgery. Cost analysis of the intervention will also be performed.~   "
72701|NCT02615353|"~     Obesity and type 2 diabetes are critical public health issues in youth. This study will test~     the effects and estimate the cost-effectiveness of a culturally-grounded community-based~     lifestyle intervention on type 2 diabetes risk among obese Latino adolescents with~     prediabetes.~   "
72702|NCT02615340|"~     The purpose of this study is to determine the feasibility of conducting a randomized~     controlled trial (RCT) with melatonin for prevention of delirium in critically ill adult~     patients. The investigators hypothesize that melatonin, administered on a scheduled nightly~     basis during ICU admission, will be efficacious and safe for the prevention of delirium in~     critically ill adults.~   "
72703|NCT02615327|"~     Primary objective is to investigate the effect of polydextrose on postprandial glucose~     concentrations in healthy adults when added to a food product.~      Secondary objective is to assess gastrointestinal tolerance and acute bowel changes.~   "
72704|NCT02615314|"~     The aim of this study is to analyze the clinical aspects of patients with BPPV associated~     with migraine. It is our purpose to clarify weather migraine is a risk factor for BPPV if the~     clinical aspect and the therapeutic outcome is different.~   "
72705|NCT02615301|"~     The aims of this study were to investigate how intake of tailor-made salmon affected bone~     biomarkers, nutritional status, as well as body composition and bone mineral density. The 122~     healthy postmenopausal women included in this 12 weeks intervention study were randomized~     into four groups: three salmon groups (with three different vitamin D3/vitamin K1~     combinations) and one tablet group (vitamin D and Calcium).~   "
72706|NCT02615288|"~     This is a randomized, double-blind placebo-controlled trial of high dose vitamin D3 at 10,000~     International Units (IU) daily compared to low dose at 1000 IU daily in patients with Crohn's~     disease in remission.~   "
72707|NCT02615275|"~     The goal of this research study is to learn if mBCA, a type of scale that measures body mass~     (the amount of muscle and fat in your body) and your level of hydration can help researchers~     identify patients who are losing muscle mass during radiation therapy. This information will~     help researchers make decisions about nutritional supplementation and the placement of~     feeding tubes in patients receiving radiation therapy.~   "
72708|NCT02615262|"~     Perioperative administration of steroids has been demonstrated to reduce systemic~     inflammatory response in infants undergoing cardiac surgery with cardiopulmonary bypass.~     However, data on effects of steroids on clinical outcomes are lacking. Hence the hypothesis~     of the present study: intraoperative administration of dexamethasone reduces complication~     rates and improves clinical outcomes in infants undergoing repair of congenital heart defects~     under cardiopulmonary bypass.~   "
72709|NCT02615249|"~     48-hour application of metal allergen patches to test for potential allergic responses.~   "
72710|NCT02615236|"~     The aim of the study is to evaluate the role of routine perineal scan using 2D ultrasound~     immediatly after delivery to diagnose hidden perineal trauma that might affect patient's~     fecal continance~   "
72711|NCT02615223|"~     This trial is going to evaluate tumor control and quality of life in patients with prostate~     cancer treated with endocrine therapy with or without cryoablation.~   "
72712|NCT02615210|"~     The purpose of this study is to determine if cholangioscopically-directed biopsies provide a~     higher diagnostic yield for malignancy in the setting of indeterminate biliary strictures~     when compared to standard means of sampling.~   "
72713|NCT02615197|"~     The present project has two primary aims: (1) to examine the effectiveness of a~     multi-component implementation strategy in improving adoption and adherence to the~     Dialectical Behavior Therapy Prolonged Exposure (DBT PE) protocol, and (2) to evaluate the~     feasibility, acceptability, and effectiveness of the DBT PE protocol in a sample of~     individuals receiving DBT in public mental health agencies. This study uses a hybrid type 2~     effectiveness-implementation design to simultaneously test the clinical effectiveness of DBT~     + DBT PE and to evaluate an adaptive, multi-component implementation strategy. The~     effectiveness trial will use a quasi-experimental, controlled design to evaluate outcomes~     among DBT clients with PTSD who do versus do not receive the DBT PE protocol and outcomes~     will be benchmarked to those obtained in research settings.~   "
72714|NCT02615184|"~     The purpose of this study is to assess the safety and effectiveness of treatment with once~     daily (QD) oral administration of dexlansoprazole 30 or 60 mg for 8 to 12 weeks in pediatric~     subjects aged 1 to 11 years inclusive, with erosive esophagitis (EE) and to assess the safety~     and effectiveness of dexlansoprazole 15 or 30 mg compared to placebo in maintenance of healed~     EE for 16 weeks.~   "
72715|NCT02615171|"~     The purpose of this research is to develop and test a mobile application called RELAX, which~     is designed to help with stress management during weight loss.~   "
72716|NCT02615158|"~     The hypothesis is that toddlers with parents who are randomized to a parenting intervention~     and toddlers with parents who are randomized to the maternal intervention focused on maternal~     diet and physical activity will be more likely to have weight status within normal and to~     consume a healthy diet and engage in physical activity than toddlers with parents in a~     placebo (safety) intervention.~   "
72718|NCT02615132|"~     Post-stroke communication deficits (PSCD) are a common symptom of patients having sustained a~     stroke. These deficits include difficulty to produce or understand language, motor speech~     disorders and cognitive-communication disorders. It is estimated that approximately 40% of~     stroke survivors will have communication disorders post stroke.~      In this randomized controlled study, the investigators' objective is to test the value of~     providing a mobile platform-based Speech Language Therapy (SLT) program to patients~     discharged from an acute care hospital with stroke and PSCD and awaiting outpatient rehab~     services versus standard of care treatment. The investigators will offer iPad-based~     SLT/standard of treatment to a convenience sample of 20 patients with post-stroke~     communication deficits. The primary outcome will be feasibility (recruitment rate, adherence~     rate, retention rate, and protocol deviations), and the secondary outcome will be improvement~     in PSCD.~   "
72719|NCT02615119|"~     This study aims to identify the brain regions responsible for encoding cardiorespiratory~     'interoceptive' sensations and determine whether they are dysfunctional in individuals~     affected by eating disorders, anxiety, depression, or brain injury. By evaluating the same~     interoceptive sensations across different human illnesses, the investigators hope to provide~     convergent evidence resulting in identification of core underlying neural processes, and to~     discern relative contributions in each condition.~   "
72720|NCT02615106|"~     The purpose of this study is to evaluate the safety and efficacy of Radiotherapy plus~     Endostar(Recombinant Human Endostatin) in patients with Pediatric Neuroblastoma.~   "
72721|NCT02615080|"~     This is a double-blind, randomised, placebo-controlled, parallel group, Phase 2 trial~     evaluating CRD007 administered orally b.i.d for 14 weeks for the treatment of asthma. CRD007~     will be given as add on to a background of commonly used controller medication, i.e. inhaled~     corticosteroid (ICS) with or without long-acting beta2-agonist (LABA). By gradually reducing~     the background controller medication, the efficacy and safety of CRD007 will be evaluated on~     top of several dose levels of this medication.~   "
72722|NCT02615067|"~     99mTc-MIP-1404 is a radioactive diagnostic imaging agent indicated for imaging men with newly~     diagnosed prostate cancer whose biopsy indicates a histopathologic Gleason Score of ≤ 3+4~     severity who are candidates for active surveillance and are undergoing voluntary radical~     prostatectomy (RP) [Cohort A] or routine prostate biopsy [Cohort B]. This Phase 3 study is~     designed to evaluate the specificity and sensitivity of 99mTc-MIP-1404 SPECT/CT imaging to~     correctly identify subjects with previously unknown clinically significant prostate cancer.~   "
72723|NCT02615054|"~     This is for participants with a history of HER2-positive breast cancer and were treated with~     chemotherapy that increases the risk of abnormal heart function. Strain (a marker of heart~     function) is a new method of monitoring heart function in cancer patients and is measured~     with an ultrasound. Exercise testing is another method that can be used to monitor for~     abnormal heart function in cancer patients. The purpose of this study is to see if strain and~     exercise testing can be used to detect for late signs of heart damage from chemotherapy.~   "
72724|NCT02615041|"~     The study was a randomized three-way crossover study. Each subject received meropenem in~     three regimens at room temperature consecutively: (i) bolus injection of 1 g of meropenem~     over 10 min every 8 h for 24 h, (ii) 3-h infusion of 1 g of meropenem via an infusion pump at~     a constant flow rate every 8 h for 24 h, and(iii) 3-h infusion of 2 g of meropenem via an~     infusion pump at a constant flow rate every 8 h for 24 h.~      Clinical and laboratory data such as Age,Sex, Body weight, Electrolyte, Vital signs, APACHE~     II score, BUN, Cr, Blood culture will be collected.~      Nine patients will be enrolled in this study. After completion of the meropenem therapy for 3~     days in this study, all patients will receive other sensitive antibiotics to eradicate their~     bacterial infections.~      Meropenem pharmacokinetic studies were carried out during administration of the third dose of~     each regimen (16 to 24 h after the start of each regimen). Blood samples (approximately 5 ml)~     were obtained by direct venipuncture at the following times: before (time zero) and 10 and 30~     min and~      1, 1.5, 2, 2.5, 3.5, 4, 4.5, 5, 6, and 8 h after the third dose of each regimen.~      The concentrations of meropenem were determined by reverse-phase high-performance liquid~     chromatography.~      Concentration of meropenem in plasma will be simulated in Monte Carlo technique (Computer~     model) to get PK/PD index (40%T>MIC) and reported to % PTA(Probability Target Attainment) and~     %CFR (Cumulative Faction Response)~   "
72725|NCT02615028|"~     To develop a force plate with a proper computing algorithm that can be used in the average~     household as well as within community care centers. An affordable price range will also be~     necessary.~   "
72726|NCT02615015|"~     Neutrophil extracellular traps (NETs) and deoxyribonuclease (DNase) activity determine~     outcome in ST elevation acute coronary syndrome (STE-ACS). DNase single nucleotide~     polymorphisms (SNPs) were increased in a japanese cohort.~      In the present study, the investigators seek to measure DNase SNPs frequency in a caucasian~     STE-ACS cohort compared to healthy controls (each n=400). The investigators will compute~     polymorphisms, DNase activity, NET surrogate markers and clinical variables in regression~     models.~   "
72727|NCT02615002|"~     This study is a Phase 2, randomized, placebo controlled, dose ranging study of piromelatine~     (5, 20, and 50 mg daily for 6 months) versus placebo to determine an effective dose based on~     efficacy (cognitive performance), safety and tolerability in patients with mild dementia due~     to AD.~   "
72728|NCT02614989|"~     This project goal is to explore the option of (MRgFUS) as a treatment for tremor in MS~     patients with disabling refractory tremor.~   "
72729|NCT02614976|"~     Padding with cuff during blood pressure is expected to reduce number of skin crease or~     petechiae incidence.~   "
72730|NCT02614963|"~     Clostridium Butyricum might be an effective drug in treating irritable bowel syndrome~   "
72744|NCT02614781|"~     This study is a non-interventional prospective, multicenter, longitudinal study conducted in~     France, among a representative sample of public and/or private birth control centers.~      The aim of the study is to assess, in real-life settings, the success rate of the protocol~     Mifegyne / prostaglandin analogue in patients asking for medical abortion either prior or~     beyond 7 weeks of amenorrhea.~   "
72745|NCT02614768|"~     The purpose of this study is to assess accuracy and reliability of the SPIDIMAN CGM sensor~     system with regard to values as measured by Super GL and compare these results with similar~     evaluations of the Medtronic MiniMed 640G system, the Abbott FreeStyle Libre Flash Sensor and~     the DexCom G4 Platinum Sensor in patients with type 1 Diabetes.~   "
72731|NCT02614950|"~     This is a Phase 2, two-step, open-label study of the outcome of analytic treatment~     interruption (ATI) on patients who started antiretroviral therapy (ART) during Fiebig Stage I~     of acute HIV infection (AHI), defined as detectable HIV-RNA without detectable p24 antigen or~     HIV IgM. The primary endpoint will be rate of sustained viral suppression, defined as HIV-1~     RNA < 50 cps/ml at 24 weeks after treatment interruption. During ATI subjects will be~     monitored closely for safety and will have ART re-initiated if they meet predefined clinical,~     virological, or immunological criteria. In step I, there will be 8 subjects who undergo ATI.~     An interim analysis for safety will be conducted after 12 weeks. If none of the subjects~     maintain viral suppression at 12 weeks then no further subjects will be enrolled into the~     study. If at least 1 out of 8 subjects maintains viral suppression at 12 weeks then an~     additional 7 subjects will be enrolled in step 2.~      At ATI all antiretroviral drugs will be discontinued. Subjects will be monitored with~     clinical exam, immunological (CD4), and virological (HIV-RNA) testing at baseline and then on~     a fixed schedule for 24 weeks. ART will be re-initiated immediately if subjects meet any~     pre-defined clinical, immunological or virological safety endpoints during the monitoring~     period.~   "
72732|NCT02614937|"~     This was a prospective, single center, open label, randomized study evaluating the biological~     effect of squalamine lactate ophthalmic solution, 0.2% combined with intravitreous~     ranibizumab in patients with macular edema secondary to branch, hemi-central and central~     retinal vein occlusion (BRVO, HRVO, CRVO).~   "
72733|NCT02614924|"~     The purpose of this study is to identify whether Pentax Airway Scope (AWS) videolaryngoscope~     would be a more effective device compared to flexible fibreoptic scope (FOS) for awake~     intubation in a difficult airway.~   "
72734|NCT02614911|"~     This study has been set up in order to characterize phenotypes and genotypes of patients with~     early onset enteropathies.~      In that goal, Investigators will collect biological samples (mainly blood) of patients~     suffering from early onset enteropathies and their healthy relatives.~   "
72735|NCT02614898|"~     This is a prospective, open-label study with no patient randomization. Treatment for atypical~     hemolytic uremic syndrome (aHUS) will remain observational and at the discretion of the~     treating physician. The purpose of this study is to assess disease manifestations of~     complement mediated thrombotic microangiopathy (TMA) and potential clinical predictors of~     disease manifestations and progression in patients with aHUS with or without eculizumab~     treatment in the clinical setting.~   "
72736|NCT02614885|"~     This is a single-arm, prospective study of a radiofrequency ablation device on the excised~     breast tissue of ten (10) prophylactic mastectomy patients. The ablation lesion created by~     the device will be analyzed histologically.~   "
72737|NCT02614872|"~     This study evaluates the safety and efficacy of intravenous GLASSIA® treatment in lung~     transplantation.~   "
72738|NCT02614859|"~     Obesity and metabolic syndrome are prevalent among prostate cancer patients. Having an~     elevated insulin level in the blood is associated with a shorter median time to cancer~     progression and median overall survival in patients with an elevated PSA after prior~     treatment. Androgen deprivation therapy (ADT) with drugs like bicalutamide is frequently used~     in this patient population,with no proven benefit, which may increase mortality and~     morbidity.This study evaluates how metformin in combination with bicalutamide affects~     prostate cancer.~   "
72739|NCT02614846|"~     This study evaluates the safety and efficacy of 6 weeks dosing Hetrombopag Olamine in Chronic~     Idiopathic Thrombocytopenic Purpura Patients. All of the subjects in this study receive~     Hetrombopag.~   "
72740|NCT02614833|"~     The proposed Phase IIb clinical study aims to investigate the safety and efficacy of the~     active immunotherapy IMP321 in combination (adjunctive) with paclitaxel chemotherapy in~     patients with hormone receptor-positive metastatic breast cancer.~   "
72741|NCT02614820|"~     Background: Duchenne muscular dystrophy (DMD) is an X chromosome recessive hereditary disease~     and mainly characterized by progressive muscle weakness and atrophy. Glucocorticoid is the~     only proven effective medicine,while side effects limit its use. Recent studies have shown~     that the vascular density in the DMD patients' muscle is decreased,so muscle are in ischemic~     and anoxic. Remote ischemic preconditioning(RIPC) can improve the capable of resistanting~     ischemia and hypoxia and maybe a potential therapy for DMD patients.~      Methods: 100 patients (aged 2 to 6 years)will be divided into two groups(treatment and~     control groups) randomly. Treatment group will receive an RIPC stimulus (inflation of a blood~     pressure cuff on the bilateral thighs to 150 mm Hg for four 5-minute intervals) while control~     group will receive a similar stimulus (inflation of a blood pressure cuff on the bilateral~     thighs to 40 mm Hg for four 5-minute intervals). Serum kinase level ,Blood levels of~     myoglobin, Evaluation of motor function(Four steps test;6-minute walking test) and MRI of~     lower limbs）at 0 days, 3 days, 3months ,6months.~      Purpose：~        1. To evaluate the safety and tolerability of remote ischemic preconditioning for DMD~          patients~        2. To identify the effectiveness of remote ischemic preconditioning for DMD patients.~   "
72742|NCT02614807|"~     High blood pressure is very common among elderly Canadians. Clinical trials show clear~     benefit from lowering blood pressure in hypertensive elderly patients. These trials also~     demonstrate safety for several classes of blood pressure lowering drugs including water~     pills. However, water pills (thiazide diuretics) used for treatment of hypertension, can~     cause low sodium (hyponatremia), a significant clinical problem mainly among elderly and very~     elderly. Causes are age related decrease in kidneys' ability to get rid of water and low salt~     coupled with high water intake. A standard approach to treatment is lacking since higher salt~     intake may worsen hypertension, and lower water and higher protein intake is difficult to~     understand and actually implement. 'Nepro' is a nutritional drink high in protein, and low in~     potassium and sodium. It is used frequently as a dietary supplement in patients with kidney~     disease specifically for low sodium and high protein content. The high protein content in~     Nepro can help the kidney get rid of excess water, and the low sodium and potassium content~     will make this a safe option to use. Hence investigators propose a proof-of-concept trial on~     an easy to understand and administer, and relatively affordable solution to this issue. It~     could be summarized in one sentence: Will a bottle of Nepro a day keep thiazide-caused~     hyponatremia and the doctor away?~   "
72743|NCT02614794|"~     To assess the effect of tucatinib vs. placebo in combination with capecitabine and~     trastuzumab on progression-free survival (PFS) per RECIST 1.1 based on independent central~     radiology review.~   "
72748|NCT02614729|"~     The purpose of the main study is to determine whether the daily consumption of protein-rich~     meals containing high quality, lean beef products improves appetite control and cognitive~     function during a weight maintenance diet.~      The purpose of the sub-study is to determine whether the daily consumption of protein-rich~     meals containing the same amount of high quality, lean beef products improves appetite~     control and cognitive function during a modest energy restriction, weight loss diet.~   "
72749|NCT02614716|"~     The main purpose of this study is to learn more about the safety and side effects of the~     study drug known as LY3090106 in participants with Sjögren's Syndrome (SS). The study will~     also evaluate how much of the study drug gets into the blood stream and how long it takes the~     body to remove it.~   "
72750|NCT02614703|"~     Neoplasia in Barrett's esophagus could be missed during routine random biopsies. We propose a~     study using chromoendoscopy with Acetic Acid to increase the yield of biopsies in detecting~     neoplasia.~   "
72751|NCT02614690|"~     This study aims to examine the need for univalve or bivalve splitting of casts in pediatric~     patients with forearm fractures following closed reduction and cast application in a~     randomized, prospective fashion.~   "
72752|NCT02614677|"~     Before 2007, the disability evaluation was based on the medical model in Taiwan. According to~     the People with Disabilities Rights Protection Act announced on 11 July 2007, the assessment~     of a person's eligibility for disability benefits has to be determined as suffering one of~     eight malfunction categories based on the International Classification of Functioning,~     Disability, and Health (ICF) framework. People with disabilities want to issue a disability~     identification and other welfare & services need processes of evaluation & assessment based~     on the ICF framework for the evaluation report and result of living need by the committee~     composed of professionals from medicine, social work, special education and employment~     counseling and evaluation.~      In this year, investigators planed the project with the Taiwan Society of ICF to develop the~     evaluation form. The experts from various disciplines of the ICF Office convened internal~     integration meetings to reach a consensus for developed the ICF evaluation form, add the code~     of pain and sleep and the items from Short-Form 12 for quality of life to the questionnaire.~     The results were used to analysis other relevant factors affecting the disability evaluation.~     And then add the core set from World Health Organization to both physical and mental~     disorders linked coding group, compared the new disability evaluation system and evaluate the~     living need of people with disability to provide suggestion for core set.~   "
72753|NCT02614664|"~     Patients with single ventricle physiology (hypoplastic left heart syndrome, tricuspid~     atresia) frequently have feeding difficulties necessitating procedures such as Nissen~     fundoplication and G-tube placement. With advances in minimally invasive surgery, these are~     frequently performed using laparoscopic techniques. Although generally safe and effective,~     the increase in IAP during laparoscopy may increase systemic and pulmonary vascular~     resistance and decrease cardiac output. This prospective study will include 50 patients with~     single ventricle physiology presenting for laparoscopic procedures. There will be no change~     in the anesthetic or perioperative care of these patients. Tissue and cerebral oxygenation~     will be monitored using near infrared spectroscopy (NIRS).~   "
72754|NCT02614651|"~     The main objective of this study is to quantify vision parameters in subjects with concentric~     visual field constriction, and this in relation to the display on virtual reality goggles.~     More specifically:~        -  The maximum brightness value for visual comfort (THRESHOLD_MAX)~        -  The minimum value of the perceptible light contrast in low light perceptible~          (THRESHOLD_MIN)~        -  The speed of light change adaptation in the range [THRESHOLD_MAX-THRESHOLD_MIN] and~          [THRESHOLD_MIN-THRESHOLD_MAX].~   "
72755|NCT02614638|"~     The main objective of this study is to evaluate the impact of the presence of a pharmacy~     technician in a care unit (Hepato-Gastroenterology Department) on detected medication errors.~      This is a before-after study consisting of three sequential phases:~      Month 1: one month of observation of what is happening in the department Month 2: one month~     wash out period Month 3: active participation of a pharmacy technician in the department~   "
72756|NCT02614625|"~     An increasing number of clinical studies on SD-OCT of ocular pathologies and potential new~     clinical applications has recently been published in the peer-reviewed literature. However,~     the successful use of SD-OCT in routine clinical use depends upon the diagnostic sensitivity,~     biometric accuracy and reliability of the SD-OCT machines. This prospective, comparative,~     observational study aims to evaluate the imaging quality and diagnostic performance of two~     commercially available SD-OCT machines for both the anterior and posterior segment of the~     eye.~   "
72757|NCT02614612|"~     To determine if Itacitinib in combination with corticosteroids is safe and tolerable in~     patients with Grade IIB-IVD acute graft-versus-host disease (GVHD).~   "
72758|NCT02614599|"~     Multicenter, Prospective, randomized, comparative and controlled study about the beneficial~     effects in behavior and brain connectivity of different dietary patterns in 100 children with~     ADHD between 7 and 12 years, followed up for 3 months of nutritional therapy.~   "
72759|NCT02614586|"~     The purpose of this study is to determine whether improvement in P50 (a pharmacodynamic~     marker) in auditory sensory gating is demonstrated after administration of TAK-058 and~     ondansetron compared to placebo in participants with schizophrenia.~   "
72760|NCT02614573|"~     The main objective of this study is to evaluate, for a 6-month observation period, the~     concordance in terms of clinical decision making concerning therapeutic adjustment as~     determined by a weekly capillary International Normalised Ratio (INR) monitoring strategy~     versus the usual strategy in a population of dependent elderly people in nursing homes,~     treated with anti-vitamin K (AVK).~   "
72761|NCT02614560|"~     This study will examine the safety and anti-leukemic profile of SGN-CD33A (vadastuximab~     talirine) in patients with relapsed chemo-resistant AML, who are given vadastuximab talirine~     in sequence with standard treatments before a planned stem cell transplant, or as maintenance~     therapy after a stem cell transplant. The main purpose of the study is to find the best dose~     and determine the anti-leukemic activity of vadastuximab talirine, given either pre- or~     post-allogeneic stem cell transplant (alloSCT) for adults with relapsed or refractory AML.~     This will be determined by assessing the safety and tolerability of vadastuximab talirine. In~     addition, the pharmacokinetic profile and anti-leukemic activity of the study treatment will~     be assessed.~   "
72764|NCT02614521|"~     Atrial fibrillation is the most common serious abnormal heart rhythm affecting about 2% to 3%~     of the population, being associated with a 1.5- to 1.9-fold higher risk of death. Patients~     with paroxysmal AF in whom antiarrhythmic drug therapy does not elicit a response are~     potential candidates for RF ablation of AF. The success rate of RF ablation in the treatment~     of AF varies depending on the type and duration of AF (ie, paroxysmal vs persistent),~     structural remodeling of the heart, co-morbidities and the technique of the cardiac~     electrophysiologist, but it usually ranges from 60-80% over 1-2 years of follow-up.~      To study and predict the successful outcome of RF ablation is of great clinical importance.~     Moreover, the detection of predictive factors for successful outcome may alter the~     therapeutic strategy determining a subgroup of patients in the need of more invasive~     management.~   "
72765|NCT02614508|"~     This phase I trial studies the side effects and best dose of buparlisib when given together~     with ofatumumab or ibrutinib in treating patients with chronic lymphocytic leukemia that has~     returned after a period of improvement or does not respond to treatment. Buparlisib and~     ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell~     growth. Monoclonal antibodies, such as ofatumumab, may block cancer growth in different ways~     by targeting certain cells. Giving buparlisib or ibrutinib and ofatumumab together may work~     better in treating patients with chronic lymphocytic leukemia.~   "
72766|NCT02614495|"~     A multi-center , opened, Phase II study to assess the efficacy and safety of Sulfatinib 300~     mg Sulfatinib in advanced Medullary Thyroid Carcinoma ( MTC) and iodine-refractory~     differentiated thyroid carcinoma (DTC).~   "
72767|NCT02614482|"~     The purpose of this study is to evaluate the long term tolerability of Fesoterodine and its~     efficacy for overactive bladder syndrome in children.~   "
72768|NCT02614469|"~     The purpose of this study is to assess the effects of food on the amount of urate in the body~     after a single oral dose of inosine.~   "
72769|NCT02614456|"~     This is a phase I study of combination immunotherapy with IFN-γ and the PD-1 inhibitor~     nivolumab in patients with advanced solid tumors who have progressed on at least one prior~     systemic therapy, which may include prior immunotherapy.~   "
72770|NCT02614443|"~     The aims of this study are to test the effectiveness and acceptability of internet-delivered~     treatment for depression, anxiety and stress in university students. These data will inform~     the methods for a future randomized controlled trial.~      The trial will establish an initial estimate of the effectiveness of these online~     interventions for students in terms of within-group effect sizes associated with changes in~     depression, anxiety and stress from pre to post-intervention and follow-up. These data will~     be used to estimate the sample size for a future trial to ensure that the study is~     sufficiently powered. A conservative estimate using the 90% upper confidence limit will be~     used to inform the sample size calculation of the definitive RCT.~      Acceptability of the intervention to participants will be assessed using data on usage and~     engagement with the intervention (e.g. percentage of participants completing each module,~     average number of log ins, average time spent per session and total time spent on the~     program). These data are acquired through the online SilverCloud system. Satisfaction with~     will be assessed through the use of a post-intervention questionnaire on satisfaction with~     accessing and using an online delivery format for treatment.~   "
72771|NCT02614430|"~     The project will investigate levels of physical, psychosocial functions and inflammatory~     biomarkers in a group of patients who by self-assessment indicates a perceived risk of~     decline in work ability after hospital admittance. The patients will be randomised to an~     intervention of physical training and followed for development in functional levels compared~     with patients not receiving the intervention. The goal is to validate measures of work~     ability assessment in connection to hospital admittance. The validation will provide~     important information about the quality of rehabilitation services that many municipalities~     provides through private suppliers - and where the effect on work ability lacks~     evidence-based documentation.~      The project aims to link patient treatment to recovery and an optimal return to everyday~     life, comprising the patients work life. The frame is a multi-sectoral accepted platform for~     assessing patients' needs for care, treatment and rehabilitation, which is based on a~     professional assessment of the efficacy and quality of, varies heath care related deliveries.~     The acceptance of a multi-sectoral creates a need for accessible clinical tests of physical~     and mental functioning, combined with biomarkers to identify patients need.~      The project investigates whether it is possible to identify patients (age 18 to 60 year) with~     an increased risk of losing their ability to work after discharge from an acute~     hospitalisation. And to evaluate whether measurable effects on inflammation and functional~     levels of labour oriented training program can be identified.~   "
72772|NCT02614417|"~     Sleep-disordered breathing (SDB) is a wellknown comorbidity in cardiovascular disease.~     Knowledge about SDB in adult congenital heart disease is limited.~   "
72773|NCT02614404|"~     The purpose of this study is to determine the efficacy and safety of imatinib in the~     treatment uncomplicated P. falciparum malaria.~   "
72774|NCT02614391|"~     Venipuncture is one of the painful procedures most frequently performed in children. Pain and~     distress management in children, during needle related procedures, is warranted.~      The base for pain management starts with behavioural and environmental support and~     distraction. Distraction is a cognitive strategy trying to divert the child's attention from~     a noxious stimulus. Active distraction involves the child in a different performance, e.g.~     playing, during pain procedures. Passive distraction redirects the child's attention to~     visual or auditory stimuli using toys, songs, movies or blowing bubbles.~      Blood-drawing centre is a peculiar setting in which many procedures have to be performed in a~     limited time. Patients usually arrive without a pharmacological premedication and go away~     immediately after procedure. In this context distraction is an excellent pain relief tool.~      The aim of the study is to compare the effectiveness of an active distraction (playing a~     videogame using a computer tablet) with a passive distraction technique in pain relief during~     venipuncture in a blood-drawing centre.~   "
72775|NCT02614378|"~     Evaluate the effectiveness of air insufflation in aborting (stopping) an acute episode of~     migraine and compare it with a placebo effect of using the same procedure but without active~     insufflation. The insufflation will be used when the subject is experiencing an acute episode~     of migraine to determine its ability to reduce, if not to completely eliminate the migraine~     symptoms. Subjects receiving the placebo treatment will be offered the active treatment~     during the subsequent episode of migraine.~   "
72776|NCT02614365|"~     Whereas the advantageous effects of exercise-training on memory is increasingly recognized,~     the practicality and clinical usefulness of such interventions in community-dwelling older~     African Americans (AA)s Mild Cognitively Impaired (MCI) subjects, and the mechanism by which~     an effect occurs need elucidation. Because aerobic-exercise can improve emerging~     cardiovascular (CVD)-related risk factors for cognitive decline such as lipids, inflammatory~     cytokines and glucose homeostasis; the Investigators will examine training effects on these~     and related biomarkers. The imperative for this study is further underscored by the fact~     that, AAs: i) have high rates of dementia, and ii) have paucity of cross-sectional, and lack~     prospective data on the effects of exercise on cognition. To overcome barriers to recruitment~     and retention, enhance compliance with a long exercise program (3-times/week), and maximize~     the use of available resources, the Investigators will use a community-based approach.~     Therefore, the primary objectives of this study build on the Investigators' experience, and~     will compare the effects of aerobic-exercise to stretch-exercise (control) in~     community-dwelling AA MCI subjects. Following the initial 6 months active intervention, the~     aerobic-exercise group will follow a prescribed but free living 40 minutes, 3 time/week~     exercise regimen while the control group returns to usual care plus stretch-exercise for~     additional 12 months. This study will facilitate the estimation of sample size for a larger~     confirmatory study in AAs. A newly acquired direct oversight of the DC Ward-6 Senior Wellness~     Center and its infrastructures by the Howard University Division of Geriatrics will provide~     additional resources and access to the community. In addition to the Investigator's~     feasibility aims, the Investigators will determine performance on cognitive tasks using the~     Alzheimer's Disease Assessment Scale-Cognitive Sub-scale (ADAS-Cog) and Clinical Dementia~     Rating Scale (CDR) sum of boxes supplemented by tests of executive function (EF) and~     Functional Activity Questionnaire (FA) and together as ADAS-Cog-Plus; changes in brain volume~     regions of interest (ROI) with Magnetic Resonance Imaging (MRI), selected CVD and AD-related~     bio-markers.~   "
72777|NCT02614352|"~     Primary object : Evaluate pharmacokinetic property AG1502 and Candesartan 32mg and~     Atorvastatin 40mg in healthy male subjects.~   "
72778|NCT02614339|"~     The aim of this study is to identify the effect of adjunctive metformin on recurrence of~     non-DM stage III colorectal cancer. This study is open-label randomized controlled study.~      The primary endpoint is to compare the 3-year disease free survival between metformin group~     and non-metformin group. The secondary endpoint is to compare the 5-year overall survival and~     disease specific survival between two group, to identify the safety of metformin, and to~     compare the recurrence rate of polyps after polypectomy between two groups.~   "
72779|NCT02614326|"~     A wealth of research has demonstrated that they way in which the investigators recall our~     personal, autobiographical memories is influential in the course of depression. Biases in the~     recall of autobiographical memory occur in the midst of a depressive episode, and are shown~     to prolong symptoms, however these biases also remain when depression remits, and may~     predispose the individual towards relapse. A novel cognitive intervention, MemFlex, aims to~     train individuals to be flexible in their retrieval of autobiographical memories, and thereby~     reduce depressive relapse. Changes in memory bias may also have an effect on intermediate~     processes that increase risk of depression, such as rumination, impaired problem solving, and~     cognitive avoidance. This feasibility trial compares the effects of MemFlex and~     Psychoeducation in their ability to reduce memory bias and intermediate cognitive risk~     factors, and thereby depressive relapse, in individuals remitted from Major Depressive~     Disorder. Clinical outcome and process measures will be assessed immediately following~     completion of the intervention, at 6 months post-intervention, and at 12 months~     post-intervention. If encouraging, the results of this pilot trial may provide a foundation~     for a later phase trial.~   "
72780|NCT02614313|"~     Background: Breath testing for food intolerances is becoming routine in patients with~     functional gastrointestinal disorders (FGID). Both FGID and saccharide intolerances (FODMAPs:~     fermentable oligo-, di-, polysaccharide and polyols, e.g. lactose, fructose, sorbitol) are~     common (>10% of any given population) and often respond to dietary modification. The breath~     tests are based on quantification of gas excretion in breath as a sign of malabsorption and~     symptom provocation, but are likely subject to considerable psychological bias. The role of~     expectation and other psychological effects on breath testing has not been reported, but is~     crucial for the validation of these increasingly wide-spread tests with considerable dietary~     and potentially deleterious consequences. Fructose has been shown to result in short term~     pro-inflammatory metabolic responses, but these effects have not been studied as underlying~     causes for intolerance symptoms in fructose intolerant patients with FGID.~      Aim: To investigate the psychological component and the short-term metabolic effects of~     fructose breath testing in patients referred for evaluation of FGID using placebo.~     Additionally, to assess baseline predictors for a positive breath test result.~      Methods: Fructose intolerance (defined by a positive symptom index) and malabsorption~     (defined by increased breath hydrogen/methane concentrations) will be determined in 30~     successive male and female FGID in a single centre using breath-testing. Fructose 35g, given~     double-blind as well as open, a sweet placebo (cyclamate/saccharine; Assugrin®) and a neutral~     (still water) placebo given double-blind will be compared in a randomized, cross-over~     sequence and according to our standardised procedure on four separate study days. Symptoms~     will be recorded using standardised questionnaires and breath concentrations of H2 and CH4~     will be measured during testing on the four study days. Somatisation and psychological~     profiles will be assessed by questionnaires. Blood samples will be obtained before and during~     provocation testing to assess short-term responses to fructose loading by metabolomics.~     Fructose, blinded and open, and placebo responses will be compared and baseline predictors~     for a positive breath tests assessed.~   "
72781|NCT02614300|"~     Pulmonary rehabilitation programs are part of the multidisciplinary treatment of some chronic~     respiratory diseases such as COPD (chronic obstructive pulmonary disease). Although clinical~     guidelines of other diseases such as non-cystic fibrosis bronchiectasis (nCFBE) discuss the~     benefits of these programs in quality of life and exercise tolerance, evidence of such~     intervention in nCFBE patients is insufficient. Longer studies are needed with larger sample~     sizes and optimized to maximize the response and maintain long-term benefits. The present~     study aims to examine the effects in exercise tolerance of a pulmonary rehabilitation program~     combined with respiratory physiotherapy in patients with nCFBE. It is a randomized controlled~     clinical trial with a total duration of 24 months. The intervention will be performed during~     12 weeks and then will be a period of 12 months of maintenance. This is a multicenter study~     involving the following Hospitals: Hospital Clinic, Hospital la Plató and Hospital del Mar of~     Barcelona, Hospital Josep Trueta of Girona, Royal Infirmary of Edinburgh and Fondazione~     Maugeri di Lumezzane of Italy. Subjects will be randomized into three groups in a ratio (1:~     1: 1) (1) Pulmonary Rehabilitation (2) Chest Physiotherapy and (3) Pulmonary Rehabilitation +~     Chest Physiotherapy. Hospital la Plató from Barcelona will be responsible for carrying out~     the Control Group. The primary endpoint will be the test of endurance shuttle walk test.~   "
72782|NCT02614287|"~     The main purpose of this study is to evaluate the longer term safety of the study drug known~     as galcanezumab in participants with episodic or chronic migraine.~   "
72783|NCT02614274|"~     The Nutramax test article is a nutritional supplement that contains several ingredients shown~     to potentially provide benefit to patients suffering from a painful and sometimes~     debilitating condition of the knee called osteoarthritis.~      This is a pilot study that is intended to determine whether results from a proprietary~     testing panel conducted on blood and urine samples will correlate with data from physical~     examination and validated surveys that measure participants' quality of life and physical~     capabilities.~   "
72787|NCT02614222|"~     The objective of this research is to determine if the addition of the Clear Guide ONE, a~     Computer Assisted Instrument Guidance (CAIG) system, provides improvement over existing~     ultrasound guided, needle-based procedures for peripheral nerve blocks. The ultrasound can~     visualize the targeted vessel or nerve, but the addition of the CAIG may help the clinician~     better guide the needle to the target.~   "
72788|NCT02614209|"~     Plasma specimen collected from patients presenting in the Emergency Department (ED) with or~     without Heart Failure (HF) and prescribed a BNP.~   "
72789|NCT02614196|"~     The main purpose of this study is to evaluate the efficacy of the study drug known as~     galcanezumab in participants with episodic migraine.~   "
72790|NCT02614183|"~     The main purpose of this study is to evaluate the efficacy of the study drug known as~     Galcanezumab in participants with episodic migraine.~   "
72791|NCT02614170|"~     The study objectives are described below:~        1. Obtain matched serum, plasma [(K2 EDTA, Sodium Heparin (NaH), Lithium Heparin (LiH)] and~          urine specimens collected from a minimum of 50 healthy subjects. Specimens will be used~          to determine a reference range for C-peptide and insulin assays, used as an aid in the~          assessment of C-peptide and insulin in adults.~        2. Obtain serum and urine specimens collected from a minimum of an additional 200 healthy~          subjects. Specimens will be used to determine a reference range for C-peptide and~          insulin assays, used as an aid in the assessment of C-peptide and insulin in adults.~        3. To store any remaining specimens for use in future assay development and to evaluate as~          yet undetermined assays for the development of IVDs, including additional C-peptide or~          insulin assays.~   "
72792|NCT02614157|"~     Lateral lymph nodes (LLD) metastasis is a major cause of local recurrence for advanced rectal~     cancer. As for the treatment strategies on LLN metastasis, there are huge controversies on~     whether lateral pelvic lymph nodes dissection (LLND) after neoadjuvant chemo-radiotherapy~     (nCRT) between Western and Eastern countries. Retrospective cohort evidences indicate that~     LLND following total mesorectal excision (TME) will bring benefit from cT3-4 rectal cancer,~     not regular predictive LLND, which will bring more side effects on the contrary. Existing~     reports tend to recommend LLND for specific individual with suspicious LLN metastasis.~     Moreover, there is a blank strict prospective randomized control study on the comparison of~     LLND+TME and LLND after nCRT. Therefore, our trial will compare the efficacy and safety of~     the two strategies for mid/low rectal cancer with suspicious LLN metastasis. The risk factors~     (such as radiologic factors, pathologic factors, and serum protein) to predict local~     recurrence and overall survival will be further investigated.~   "
72793|NCT02614144|"~     This project aimed at analyzing and assessing of the early and late Hospital-Acquired~     Pneumonia(HAP) bacterial pathogens and their resistance to antimicrobial agents. The~     incidence of their resistance to antimicrobial agent is assessed. Included are patients~     hospitalized in the Intensive Care Departments of cooperated University hospitals, who~     developed early or late HAP. Bacterial pathogens and their resistance to antibiotics are~     identified using standard microbiological methods. The patient's mortality with respect to~     their initial antibiotic therapy is statistically analyzed.~   "
72794|NCT02614131|"~     The main purpose of this study is to evaluate the safety and tolerability of the study drug~     known as LY2599666 in different groups of people - those who are healthy, those who have mild~     cognitive impairment due to Alzheimer's Disease (AD), and those with mild-to-moderate AD. The~     study will measure how much LY2599666 gets into the bloodstream and how long it takes the~     body to get rid of it. It will also evaluate how LY2599666 affects the body. The study has~     three parts. Part A will last about 2 months. Parts B and C will each last about 23 weeks.~     Participants may only enroll in one part.~   "
72795|NCT02614118|"~     The aim of this study is premedication efficacy of analgesics on post endodontic pain.~     Sixty-six healthy adult volunteers including criteria, are participating. The patients will~     be divided into 3 groups and will be randomly given one of pre medications including 1) 10 mg~     Ketorolac, 2) 10 mg Ketorolac plus 1000mg Acetaminophen, and 3)Placebo, 45 minutes before~     applying the injection. All patients will receive standard root canal treatment. Patients~     will record their post treatment pain using a Heft parker Visual Analog Scale(VAS). Success~     will be considered as no or mild pain (VAS≤54)with no need to take analgesic. Data will be~     analysed using Mann-U-Whitney and Kruskal-wallis tests.~   "
72796|NCT02614105|"~     The primary aim of the study is to investigate whether pelvic floor muscle training or~     cough-suppression therapy reduces symptoms of urinary incontinence amongst women with chronic~     obstructive pulmonary disease grade 1-4 (mild to very severe disease).~   "
72797|NCT02614092|"~     This two-year study will evaluate the feasibility of an exercise training augmentation for~     cognitive training intervention to improve memory performance in Veterans with a diagnosis of~     amnestic Mild Cognitive Impairment (aMCI). This is a two-phased trial: 1) an exercise phase~     and 2) a cognitive training program. The exercise phase will be an aquatic based exercise~     program. A combination of exercise and cognitive training programs designed for persons~     without cognitive impairment have significantly improved memory more than other single~     intervention groups (exercise only, cognitive training only) and given the success of~     combination training programs with healthy older adults, it is important to adapt these~     programs for persons beginning to exhibit clinically significant memory problems, such as~     those with aMCI.~   "
72798|NCT02614079|"~     This study is to objectively evaluate the success of a spinal cord stimulator (SCS) trial~     using testing (DSSEP) to determine if the paresthesia (tingling sensation) or pain reduction~     achieved correlates with the degree of stimulation.~   "
72799|NCT02614066|"~     This is a single arm, open-label, multi-center, phase 1/2 study, to determine the safety and~     efficacy of KTE-C19, an autologous anti-CD19 chimeric antigen receptor (CAR)-positive T cell~     therapy, in relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL).~   "
72800|NCT02614053|"~     The purpose of this study is to evaluate the use of continuous noninvasive intraoperative~     plethesmography variability index in conjunction with Hemoglobin levels monitoring using~     Masimo Radical-7™ Pulse CO-Oximeter during elective cesarean sections in patients with~     antepartum and intrapartum hemorrhage as a guide for fluid and blood transfusion practice .~   "
72801|NCT02614040|"~     This study will be a cluster-randomized, single-center trial comparing 0.9% saline (normal~     saline) vs physiologically-balanced crystalloid fluids (Lactated Ringers or Plasmalyte A) for~     intravenous fluid administration in the emergency department.~   "
72803|NCT02614014|"~     Main aim is to evaluate the role of stress in the evolution of inflammatory bowel disease~     (IBD) and the quality of life of these patients. A second aim is to establish the existence~     of any psicopathological profile in these patients. We designed a prospective experimental~     study were patients are randomized to receive or not a cognitive-behavior program. Patients~     will be evaluated at 3 and 12 months after the program and study variables will be measured:~     stress level, coping strategies, quality of life, activity of disease and biological~     variables related to IBD.~   "
72804|NCT02614001|"~     Objectives: Little has been known the effectiveness of respiratory muscle training in~     patients with both stroke and heart failure. To investigate the feasibility and effectiveness~     of the inspiratory muscle training (IMT) in the respiratory muscle strength, cardiopulmonary~     function, exercise capacity, fatigue and quality of life in stroke patients with congestive~     heart failure.~      Design: A single-blind prospective randomized controlled study. Setting: A tertiary care~     medical center. Participant and method A total of twenty stroke patients with stable CHF,~     class I-III [NYHA (New York Heart Association)], aging between 20 to 85 year-old, will be~     eligible and randomly assigned into IMT and control group. Stroke will be confirmed by~     computerized tomography or magnetic resonance imaging. And CHF will be confirmed by a~     cardiologist. Both of groups will receive a conventional stroke rehabilitation program and~     diaphragmatic breathing training. The IMT groups will be trained daily, 30 minutes per day,~     at least 5 times a week, for 4 weeks; then readmitted to hospital 2 weeks later. For checking~     the compliance of IMT at home, patients will be monitored by making a phone call to them~     twice a week. Or patient will receive an out patient program about 10 weeks if they are not~     admitted to our hospital.~      Main outcome measurement:~      Each subject's baseline characteristics, and duration of the disease, neurological level~     (Brunnstrom's stage), functional level, spirometry; resting heart rate, blood pressure,~     resting oxyhemoglobin saturation (SpO2), lowest resting SpO2, maximal inspiratory pressure,~     maximal expiratory pressure, the resting oxyhemoglobin saturation (SpO2), lowest resting SpO2~     and Borg's scale during a 6-minute walking test , handgrip strength, visual analog scale for~     severity of fatigue, fatigue assessment scale, Barthel scale will be assessed before and~     after program.~   "
72805|NCT02613988|"~     This clinical trial studies advanced MR imaging techniques in measuring early response of~     standard treatment may become predictors of long-term treatment response in patients with~     newly diagnosed glioblastomas.~   "
72806|NCT02613975|"~     Positional therapy is considered as a kind of conservative treatment especially for patients~     with OSA which varies with body positions, and has been reported to be useful in selected~     cases especially those with positional OSA. Positional OSA is present when the overall apnea~     hyponea index (AHI) is > 5/hr with a supine AHI being more than 2 times of AHI in other~     positions, in a symptomatic patient. There will be 2 groups of patients in this study. Group~     1 consists of patients with positional OSA who refuse CPAP or tolerate CPAP poorly. They will~     be provided with a vibration device as treatment, which will be worn on the neck during~     sleep. This device senses the position of the patient during sleep. It will vibrate when the~     patient lies supine until the patient turns laterally, thus prevents the patient to lie flat~     during sleep and reduce the severity of OSA. It will be switched on and off for a period of~     15 days alternatively with sleep study performed at the end of each period respectively to~     determine its efficacy in the on and off mode. There will be a wash out period of 1 week in~     between the on and off period to remove any residual effect. Group 2 consists of patients~     with positional OSA who are using dental device but response or tolerated poorly. They will~     use the vibration device with dental device together as dual therapy, to assess the role of~     combination therapy. The device will be operated in on and off mode with sleep study being~     performed in a similar manner as in group 1. Informed consent will be signed. Each~     participant will have 2 sleep studies performed at home, which will be supported technically~     by technician visiting their home for hook up of necessary equipment.~   "
72807|NCT02613962|"~     In the light of the development of high-throughput technologies enabling a biology-based~     reclassification of tumors and the increasing number of available specifically targeting~     anticancer agents the era of precision medicine has begun. Several clinical precision~     medicine trials with the aim of stratifying treatment according to molecular profiles (for~     example in France: 'MOlecular Screening for CAncer Treatment Optimization' MOSCATO-01, SHIVA,~     PROFILER, Safir01, Safir02) are ongoing in adults and have shown the feasibility of this~     approach. MOSCATO-01 is the first trial worldwide including pediatric patients, performing an~     on-purpose intervention and molecular profiling in recurrent tumors. Together with more than~     500 adult patients, between December 2012 to August 2014, the tumors of 35 children and~     adolescents have been profiled, confirming that this approach is feasible in pediatric~     patients albeit with accelerated time stringencies. Importantly, the results of the first~     children and adolescents profiled showed that 2/3 of patients had 'actionable' alterations~     using hot spot mutations sequencing and CGH array (Geoerger B et al, ASCO 2014).~      The project 'MAPPYACTS' will use both Whole Exome Sequencing (WES) and RNA Sequencing of~     tumor tissue to increase the number of targetable genomic alterations. Furthermore to improve~     understanding of the overall molecular profile and possible response to treatment,~     methylation array, miRNA expression profiles, and study of immunomodulators will be performed~     on tumor samples subsequently. CLIP2 (INCa-labeled early phase clinical trials centers) -~     SiRIC (INCa- labeled comprehensive cancer centers) molecular profiling and bioinformatics~     platforms will contribute with their expertise in molecular profiling projects and~     characterization of pediatric cancers. Data interpretation of molecular genetic alterations~     detected by WES and RNA Seq and treatment recommendation will be done within a~     multidisciplinary therapeutic molecular biology tumor board.~      'MAPPYACTS' will produce one of the largest cohorts of molecularly characterized relapsed~     tumors reported to date, and thanks to increased access to clinical trials since the European~     pediatric legislation, the investigators expect that 20-30% of patients can be stratified~     into a targeted trial based on the detected profile.~      It is the investigators' intention that this initiative paves the way to enrich ongoing~     clinical targeted agent trials, to increase the numbers of stratified clinical trials, to an~     earlier access to targeted agents, and will play a crucial role in the relevant development~     of these new agents in pediatric malignancies.~   "
72808|NCT02613949|"~     The purpose of this study is to test the safety and efficacy of a noninvasive cortical~     electrostimulation therapy known as Reduced Impedance Noninvasive Cortical~     Electrostimulation (RINCE) in the treatment of pain associated with fibromyalgia. Patients~     who meet the 2010 American College of Rheumatology criteria for fibromyalgia will receive up~     to 24 RINCE treatments delivered by a medical device called NeuroPoint. Approximately 45~     fibromyalgia patients will be randomized into one of three study groups. One of these groups~     will receive sham treatment, meaning they will receive no treatment at all. A second group~     will receive active RINCE treatment at a nominal signal amplitude level (treatment mode 1). A~     third group will receive active RINCE treatment at a higher than nominal signal amplitude~     level (treatment mode 2). The study's primary outcome measure will be the difference between~     active and sham treatment groups in the mean change from baseline in patients' 24-hour recall~     average pain scores. The study's hypothesis is that there will be a difference between~     treatment groups in primary outcome measure.~   "
72809|NCT02613936|"~     80 patients with mild-moderate traumatic brain injury (TBI) sustained between 3 months and 5~     years ago with prolonged postconcussive symptoms will be recruited. On Day 1 of the study~     they will undergo neuropsychological (NP) testing. They will then undergo 10 days of Left~     dorsolateral prefrontal (DLPFC) anodal transcranial direct current stimulation (TDCS) (40~     active, 40 sham) combined with cognitive training. On day 10 NP testing will be obtained~     again. On Day 30, NP testing will be repeated a 3rd time. At 6 months and 1 year, quality of~     life, depression, and post concussive symptoms will be assessed.~   "
72810|NCT02613923|"~     Participants are asked to participate in a research study of the effect of a sleep~     intervention on improving sleep habits and reducing their risk of breast cancer.~      Participants are asked to participate in this research study because they have been~     identified as being at higher than average risk of developing breast cancer.~      The purpose of this study is to compare women who get a sleep intervention to women who do~     not get a sleep intervention. This study team will compare these two groups of women to see~     if the sleep intervention improves their sleep and if it lowers markers of inflammation that~     have been associated with an increased risk of breast cancer.~   "
72811|NCT02613910|"~     This study is designed as a multi-country, multicenter, open label extension to Phase III~     trial OPV116910. The primary objective is to provide continued treatment with ofatumumab~     subcutaneous (SC) for eligible subjects who complete the OPV116910 trial in order to obtain~     further long term safety and tolerability information in subjects with pemphigus vulgaris~     receiving ofatumumab SC every 4 weeks (wk).~   "
72812|NCT02613897|"~     This is a 16-week, single center, randomized, double-blind, active-controlled,~     parallel-group, Phase 3b efficacy and safety study of simultaneous administration of~     saxagliptin 5 mg plus dapagliflozin 10 mg once daily (QD) compared with dapagliflozin plus~     placebo for saxagliptin, and placebo for saxagliptin plus placebo for dapagliflozin in~     patients with Type 2 diabetes who have inadequate glycemic control on metformin or~     metformin/sulfonylurea.~   "
72813|NCT02613884|"~     Children with Cystic Fibrosis, ages greater than and equal to 36 months of age and less than~     or equal to 18 years of age, with a 25OHD level less than 30 ng/dL will be asked to~     participate in this study. Upon consent, they will be given oral cholecalciferol~     supplementation of 250,000 IU during their next CF clinic visit. The safety will be assessed~     by measuring a serum calcium level within 1 week of supplementation. Efficacy will be~     assessed using repeated 25OHD levels throughout the course of 12 months. Feasibility will be~     assessed with the previous two measures as well as a brief questionnaire administered via~     telephone within 1 week of supplementation.~   "
72814|NCT02613871|"~     This study will evaluate the antiviral efficacy, safety, and tolerability of~     ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with chronic genotype~     1 or 2 HCV who are co-infected with HBV in Taiwan.~   "
72815|NCT02613858|"~     The Preempt study is likely to help determine the frequency of patients suffering from~     Minimal Hepatic Encephalopathy (MHE) and are cirrhotics. It will also enable us to know about~     the Quality of life of these patients.~   "
72816|NCT02613845|"~     The Diagnostic and Statistical Manual of Mental Disorders, 5th ed. (DSM-5) describes delirium~     as a disturbance in attention (i.e., reduced ability to direct, focus, sustain, and shift~     attention) and awareness (reduced orientation to the environment). In addition, a~     disturbance in cognition (e.g., memory deficit, disorientation, language, visuospatial~     ability, or perception) occurs.~      Postoperative delirium (POD) usually develops in connection with a surgical procedure within~     the first five days after an intervention. Roughly 10-70% of all surgical patients above the~     age of 65 years are affected.~      POD places not only a burden to the patient and their families by increasing functional and~     cognitive damages, and increasing mortality, it also has a high impact on the health care~     resource utilization. A patient with POD often requires more intensive care, has a longer~     length of hospital stay, more complications, and often requires long-term care after being~     discharged from the hospital. All these aspects show the need for prevention of POD.~      There are various preoperative risk factors that influence the development of POD. Broad~     research has been done on this topic and shown that advanced age, cognitive impairment,~     depression and other psychopathologic symptoms, intake of psychotropic substances, sensory~     impairment like decrease in visual or auditory perception, impairment in daily life~     activities, dehydration, malnutrition, metabolic dysfunctions, urinary catheters, severity of~     disease and different comorbidities, such as chronic cardiac insufficiency, atrial~     fibrillation, or previous history of stroke or infections may favor the occurrence of POD.~      The incidence of POD is among the highest in cardiac surgery. The study was designed to~     assess predictors for POD after cardiac surgery. Study hypothesis is that some patient~     variables, scores and biomarkers are not only predictive of the incidence of POD but also of~     the severity of delirium-associated symptoms and duration of POD after cardiac surgery.~   "
72817|NCT02613832|"~     The survival of patients with lesions in the central nervous system is usually accompanied by~     physical and mental sequelae. These impairments favor the prolonged restriction to the bed,~     which may contribute with changes in respiratory function. In this context, lung re-expansion~     techniques are used to prevent or treat the various respiratory complications.~   "
72818|NCT02613819|"~     This study is evaluating the activity and efficacy of Stereotactic Ablative Body Radiotherapy~     (SABR) for the treatment of kidney cancers.~   "
72819|NCT02613806|"~     Coughing is a common adverse reaction of thyroid surgery,which could result in postoperative~     bleeding.Postoperative bleeding is a serious and potentially life-threatening~     complication，which could result in acute upper airway obstruction due to neck hematoma and~     increase the need for re-operation.The purpose of this study is to investigate whether~     dexmedetomidine can reduce the incidence of postoperative coughing and contribute to~     postoperative recovery in patients undergoing tyroid surgery with general anesthesia.~   "
72820|NCT02613793|"~     This study is recruiting two groups of women over the age of 18; those who are pregnant and~     who have pre-eclampsia; and those who are pregnant but do not have pre-eclampsia. The aim is~     to test a new method of diagnosing and monitoring pre-eclampsia and thus prevent the~     long-term damage it can cause to the baby's health. Untreated, pre-eclampsia can lead to~     seizures in pregnancy (eclampsia) and may prove fatal for mother and child.~      Currently the only effective treatment for pre-eclampsia is control of the mother's blood~     pressure until it is safe to deliver the baby. The timing of delivery is kept under constant~     review by the medical team, who must balance the risk to the mother of developing eclampsia~     against the risk to the baby of being born too early (premature).~      If pre-eclampsia can be diagnosed early, there is a greater chance of being able to treat it~     effectively. We know that women with pre-eclampsia often have exaggerated reflexes in their~     limbs (hyperreflexia) and that this may be linked to the risk of seizures. Measuring these~     reflexes might therefore be a useful way to diagnose and monitor pre-eclampsia, but doing~     this is not easy, so we want to assess whether measuring other reaction times might similarly~     help assess the risk of seizures. One possibility is by measuring the reaction time as we~     flick our eyes to follow a moving target, using an instrument called a saccadometer, which is~     worn on a head-band, a little like a head-torch.~      By comparing the results between these groups and the non-pregnant women, we will be able to~     see if reaction times from the saccadometer are altered in women with pre-eclampsia, and, if~     so, whether saccadometry might be useful in helping doctors decide the best time for safe~     delivery.~   "
72821|NCT02613780|"~     Keratoconus is a bilateral, progressive corneal degenerative disorder that often leads to~     significant visual deterioration over time. Corneal collagen crosslinking with riboflavin~     (CXL) was developed as a treatment to halt the progression of keratoconus and thus negate the~     need for corneal transplantation. However, the treatment alone has little impact in terms of~     improving visual function. Photorefractive keratectomy (PRK) is the application of an excimer~     laser to treat a patient's refractive error, therefore decreasing the dependence on~     spectacles or contact lenses for improved vision.~      Corneal collagen crosslinking combined with photorefractive keratectomy has been explored to~     partially correct the refractive error in keratoconic patients, whilst simultaneously~     stabilizing the corneal changes. Recently, the iDesign® Advanced WaveScan Studio (iDesign~     system; Abbot Medical Optics; Santa Ana, CA) has been launched as the most advanced~     high-resolution aberrometer. It is capable of mapping highly aberrated corneas for~     wavefront-guided laser procedures, and represents an important technological advance in~     treating corneal disease.~      The purpose of this single center, prospective pilot study is to assess the safety and~     efficacy of combined wavefront-guided PRK and CXL in patients with early keratoconus using~     the iDesign® aberrometer. Results of this pilot study will be used to provide sample size~     estimates for an extension of the study, which aims to determine whether sequential or same~     day procedure leads to better outcomes.~   "
72822|NCT02613767|"~     There are an increasing number of individuals in the United States with obesity, and this is~     a major health concern with links to many chronic diseases. Impairments in protein metabolism~     with obesity may disrupt muscle function and modify the dietary protein requirements in obese~     individuals. Further, overweight and obese type 2 diabetics exhibit dramatically reduced~     skeletal muscle mass compared with lean, healthy controls. Surprisingly, the influence of~     being overweight or obese on this decline in muscle mass remains understudied, despite clear~     evidence that similar metabolic impairments typically exist in these populations prior to the~     development of overt diabetes. Protein ingestion provides the amino acid building blocks to~     synthesize and repair muscle proteins in adults. Previous research has shown that the muscle~     protein synthetic response to food ingestion may be reduced in overweight/obese adults.~     However, this research provided the 'free' amino acids in small portions every 15 min during~     the postprandial period. In free living conditions, however, it is more common to consume~     protein dense foods in single portions. Currently, there is no information available on how~     eating protein rich foods affects muscle protein synthesis in overweight and obese adults.~     This proposed research will fill this research gap by being the first study to compare the~     muscle protein synthetic response to the ingestion of a meal-like amount of high quality~     protein in lean, overweight and obese adults. The objective of this study is to determine the~     muscle protein synthetic response after the consumption of 35g pork protein in lean,~     overweight and obese adults. In order to assess this objective the researchers propose to use~     primed continuous infusion of L-[ring-13C6] phenylalanine to measure muscle protein synthesis~     rates after the consumption of dietary protein. In a parallel design the researchers will~     study 13 obese (BMI 30-39.9 kg/m2) participants, 13 overweight (BMI 25-29.9 kg/m2), and 13~     age-matched lean controls (BMI 18-24.9 kg/m2) between the ages of 20 and 45 years. All~     subjects will be sedentary and weight stable for the previous 6 months. On the test day,~     subjects will remain sedentary for the determination of muscle protein synthesis in both the~     fasted state and after consumption of the protein meal. Blood and muscle sampling will occur~     on the test day.~   "
72823|NCT02613754|"~     The aim of this study is to conduct a trial to investigate the efficacy of adding Contingency~     Management (CM) to Treatment as Usual (TAU) for the treatment of Disordered Gambling. Results~     from this experiment will provide the first evidence of the additional efficacy of~     best-practice CM and whether it can be easily integrated into a clinical environment.~     Additionally, this study will correlate clinical outcomes with psychological measures and~     participant responses to develop new predictive treatment outcome measures.~   "
72824|NCT02613741|"~     Since obesity and plasma fibrinogen levels are important CVD risk factors in the adults, and~     since childhood obesity is a major risk factor for adult obesity and also because it is not~     established whether or not this is due to an increase in the FSR of fibrinogen, the~     investigators set up the studies with the following specific aims:~        1. To investigate the metabolism of fibrinogen and VLDL apoB-100, CVD risk factors, in~          childhood obesity by measuring their fractional synthetic rate (FSR) compared to lean~          age and sex matched controls~        2. To determine the outcome of a three month non-pharmacological intervention (physical~          exercise combined with controlled diet) to reduce weight on the FSR of fibrinogen and~          apoB-100~        3. To determine the relationship between FSR of fibrinogen and IL-6 in obese children and~          its potential implications on CVD before and after the non-pharmacological intervention~        4. To determine other CVD risk factors, PAI-1 levels, D-Dimer concentration, homocysteine,~          insulin, free fatty acid, HDL & LDL cholesterol and blood pressure in response to weight~          reduction (as consequence of a combined program of diet and exercise).~   "
72825|NCT02613728|"~     The goal of this clinical research study is to learn if RecoverMI care can help to shorten~     the time that patients are in the hospital after surgery and if it can help them recover~     sooner.~      RecoverMI includes the following parts:~        -  Preoperative Education~        -  Early oral intake~        -  Early mobilization~        -  Telemedicine~   "
72826|NCT02613715|"~     The main aim of this study is to evaluate the bioavailability of blackberry juice~     anthocyanins, with or without ethanol, in normal weight and overweight/obese adults.~   "
72827|NCT02613702|"~     This study will compare a new technique of free gingival graft to the original one, in order~     to evaluate the stability of the graft volume over one year and other variables. Twenty~     patients will receive the original technique of free gingival graft (controls) and twenty~     patients will receive the modified technique, in which the free gingival graft is submerged~     (tests), at the inferior incisors area.~   "
72828|NCT02613689|"~     The purpose of this study is to evaluate the feasibility, acceptability and preliminary~     efficacy of a Scheduled Gradual Reduction (SGR) intervention via Short Message Service (SMS)~     text messaging plus SMS Support Messages in decreasing smokeless tobacco use in a rural~     population.~   "
72829|NCT02613676|"~     In South Africa, healthy term newborns are usually discharged early (<72 hours after~     delivery). Many studies have shown that hospital readmission rates have increased with this~     practice, and jaundice or hyperbilirubinemia is the most common cause of readmission of~     newborns. Peak serum bilirubin levels usually occur on postnatal days 3-5, by when many have~     already been discharged putting the infant at increased risk of severe hyperbilirubinemia.~     Severe neonatal jaundice still constitutes an important cause of neonatal mortality and~     morbidity in Africa. Screening all newborns for the risk of severe hyperbilirubinemia before~     hospital could help in early identification of hyperbilirubinemia and early intervention and~     potentially prevent unwanted consequences like bilirubin induced neurological dysfunction.~     However, there are conflicting recommendations on the use of universal transcutaneous~     bilirubin screening for jaundice in all newborns before hospital discharge.~   "
85812|NCT02443831|"~     This study aims to evaluate the safety, efficacy and duration of response of CD19 Chimeric~     Antigen Receptor (CAR) redirected autologous T-cells in children with high risk, relapsed~     CD19+ haematological malignancies.~   "
72830|NCT02613663|"~     A successful implant therapy require appropriate hard and soft tissue, perfect implant~     position, appropriate alveolar ridge architecture and integration of the implant. after tooth~     extraction bone resorption takes place and affect the quantity and quality of the bone~     resulting in inadequate bone volume for implant placement and future prosthetic restoration~     and impair the esthetic, so insertion of implant immediately following tooth extraction~     reduce bone loss and enhance esthetics.the fresh socket of extracted tooth is wider than the~     implant diameter and the distance between the implant and the bone called Peri-implant gap~     which influence the stability, osseointegration of the implants and esthetics. using bone~     graft in this gap between bone and implant enhance osseointegration and post-operative~     healing. autogenous bone graft considered the gold standard graft material for filling~     defects as it is osteogenic,osseoconductive and osseoinductive, however this approach~     obtained from the primary donor site for harvesting bone in the oral cavity which requires~     longer surgical procedure and produce not enough bone volume. there are several~     post-operative complication may happen as donor site morbidity and swelling,discomfort and~     pain, so alternative treatment has been suggested using biomaterials to fill the gap and~     reduce adverse effect of autogenous grafts.Several studies evaluate the success rate of~     implants with autogenous bone graft versus other synthetic guided bone regeneration~     materials. Nano porous grafting material as a new synthetic material nanobone~     nanocrystalline hydroxyapatite embedded in a porous silica gel matrix has oseoconductive and~     biomimetic properties integrate with the host bone. the sub-micron modification in bone~     substitutes enhance osteogenic property. the objective of this study is to measure surgical~     time, pain, implant stability and marginal bone loss in immediate implant placement with~     using autogenous bone graft versus nanobone graft.~   "
72831|NCT02613650|"~     This is a Phase 1b, open label, dose-finding study to determine the Maximum Tolerated Dose~     (MTD) of MEK162 in combination with mFOLFIRI, and to evaluate the response rate, clinical~     benefit rate and additional safety parameters of the treatment combination~   "
72832|NCT02613637|"~     Registry Study on Biological Disease Profile and Clinical Outcome in Patients with Newly~     Diagnosed or Existent Lung Cancer~      The LuCa Biology and Outcome (BiO)-Project~   "
72833|NCT02613624|"~     The study is being conducted to develop an intervention to assess the feasibility of~     implementing Kangaroo Mother Care (KMC) for low birth weight (LBW) and preterm babies in a~     community setting. A prototype intervention package will be developed using information~     obtained from in-depth interviews, focus group discussions and other qualitative research~     techniques. These interviews will help us identify current behaviours, barriers to adoption~     of KMC and effective ways to promote KMC in the community. The prototype intervention will be~     refined by conducting acceptability studies (household trials) with few mothers. The study~     team are identifying LBW and preterm infants, demonstrating to mothers how to practice KMC~     and following up till KMC is stopped. The process is being documented using observations and~     interviews. Information is obtained on acceptability of KMC, number of hours per day and~     number of days KMC was given, breastfeeding practices and support provided by other family~     members.~   "
72834|NCT02613611|"~     Examination of cervical &urine samples for HPV~   "
72835|NCT02613598|"~     The primary objective of this research study is to determine the maximum tolerated dose (MTD)~     of Ruxolitinib (Jakafi) in combination with standard dose Bortezomib (Velcade) in patients~     with relapsed or refractory Hodgkin (HL) and Non-Hodgkin Lymphoma (NHL).~   "
72836|NCT02613585|"~     Lyme and other tick-borne diseases pose a significant health threat to outdoor workers. This~     study is a double-blind randomized controlled trial of outdoor workers in Rhode Island and~     the surrounding area that will address the following study aims: 1) Evaluate the~     effectiveness of LLPI clothing in preventing tick bites among outdoor workers in Lyme endemic~     areas; 2) Measure the urine levels of permethrin metabolites in study subjects; and 3)~     Measure the loss over time of knockdown activity against ticks and of permethrin in LLPI~     clothing.~   "
72837|NCT02613572|"~     Because of its iron-chelating and antioxidant properities, alpha lipoic acid may be a~     treatment for geographic atrophy secondary to age-related macular degeneration. There is~     ample published data about the safety and pharmacokinetics of alpha lipoic acid in adults.~     However, there is not much data on the safety and tolerability of higher doses of alpha~     lipoic acid in the elderly population. The purpose of Phase I of this protocol is to~     determine if there are safety/tolerability concerns seen when higher doses of alpha lipoic~     acid are taken by subjects 65 years of age or older.~      The objective of Phase 2 of this protocol is to determine the effects of ALA on the~     progression of GA in subjects with AMD. The central hypothesis, based on the existing~     literature, is that oral ALA reduces the rate of enlargement of GA in AMD subjects. The~     rationale is that the antioxidant and iron chelating effects of ALA will slow down one of the~     major pathways responsible for GA progression.~   "
72838|NCT02613559|"~     The purpose of this first-in-human study is to evaluate the safety, pharmacokinetics and~     tolerability of single ascending doses of TK001(Recombinant humanized anti-VEGF monoclonal~     antibody) to determine the maximum tolerated dose (MTD) in neovascular wet age-related~     macular degeneration (wAMD) subjects.~   "
72839|NCT02613546|"~     This research is a randomized clinical trial aims to evaluate the influence of~     cognitive-behavioral psychotherapy (CBT) on quality of life and sexual function of patients~     with sexual dysfunction. The notion of sexual health for the World Health Organization~     exceeds the concept of sickness absence, having a subjective well-being of significance in~     the spheres of self-concept, self-image, interpersonal relationships and sense of self worth.~     Furthermore, sexual satisfaction and relationship quality of life is also evidenced in many~     studies. CBT is a brief and focal psychotherapy with proven efficacy in several mental~     disorders, improving health and quality of life of the treated populations. However, they did~     not find clinical trials that showed the effectiveness of CBT in Sexual Dysfunctions. This~     study aims to then fill this gap by evaluating the relationship from the use of techniques of~     CBT.~   "
72840|NCT02613533|"~     The water drinking test (WDT), is a predictive test that has been used to detect primary open~     angle glaucoma and recently has been demonstrated as a predictor of the diurnal tension~     curve. Clinically accurate provocative tests for asymptomatic eyes with shallow anterior~     chambers and narrow angles are highly desirable to detect patients prone to angle closure~     glaucoma. The aim of this pilot study is to evaluate the possible role of water drinking test~     in patients with narrow angles who are scheduled for prophylactic laser iridotomy.~   "
72841|NCT02613520|"~     The present trial will evaluate safety and tolerability as well as the vaccine-induced~     humoral and cellular immune responses in healthy Tanzanian adults, adolescents, children, and~     infants who receive doses of 1.8x10^6, 9.0x10^5, 4.5x10^5 or 2.7x10^5 PfSPZ of PfSPZ Vaccine~     by direct venous inoculation (DVI),compared with control groups receiving normal saline (NS)~     placebo by DVI. In addition, as an exploratory objective, controlled human malaria infection~     (CHMI) will be used to assess efficacy in adults three weeks following immunization.~   "
72847|NCT02613442|"~     Objective: To determine the clinical variables that influence aqueous outflow facility (Co)~     and intraocular pressure (IOP) in uveitis.~      Uveitic glaucoma is potentially blinding and occurs in 17-46% of chronic uveitis patients.~     Uveitic activity causes fluctuating IOP due to decreased Co, increased uveoscleral outflow or~     decreased aqueous production.~      Specific Aim 1: To evaluate the risk factors for high IOP and low Co in uveitis Hypothesis:~     Decreased Co and increased IOP will occur with increasing anterior chamber (AC) flare, AC~     cells, degree of synechial angle closure, increased duration of disease, higher uveitis~     activity and increasing steroid use Specific Aim 2: To determine prospectively the effect of~     AC flare on Co and IOP in quiescent uveitis Hypothesis: AC flare even in the absence of AC~     cells will cause progressive decline in Co.~      Methods: In this proof of concept study, thirty consecutive patients with acute or chronic~     uveitis will be recruited from the uveitis clinic. Ten patients with quiescent uveitis (no~     AC cells) will be recruited for the prospective arm and followed every 2-3 months for 3~     visits. Co will be measured using 2-minute pneumatonometer tonography. The effect of risk~     factors on IOP and Co in uveitis will be studied using generalized linear modelling~     techniques. These risk factors include AC flare (using the laser flare meter), AC cells,~     degree of angle closure (by gonioscopy), duration of disease, disease activity and~     corticosteroid use within the last year. In the prospective study, the patients will be~     divided into subgroups with low flare (< 20ph/ms) and high flare (≥ 20 ph/msec) and the~     change in Co and IOP will be analyzed.~      Impact: This will be the first study to systematically analyze the risk factors for decrease~     in Co and increase in IOP in uveitis and to prospectively evaluate the effect of AC flare on~     Co. Proof that AC flare can damage the trabecular meshwork will corroborate previous~     experimental evidence and change the paradigm of uveitis treatment. Knowledge of the risk~     factors that affect Co and IOP will aid in identifying patients that may need escalation of~     their uveitis or glaucoma treatment to prevent optic nerve damage.~   "
72848|NCT02613429|"~     Literature shows that anaesthetists have a low success-rate when trying to access the airway~     percutaneously in case of failed ventilation and intubation.~      The study will investigate anaesthetists ability to locate the trachea and the thyroid~     cartilage and the cricoid cartilage in patients, using different methods including~     application of ultrasonography.~   "
72849|NCT02613416|"~     This is a non-randomized phase II trial of denosumab at 120 mg subcutaneous injection monthly~     in pre- and post-menopausal women diagnosed with stage 0-III breast cancer who are currently~     not receiving anticancer treatment with hormonal therapies, chemotherapy, or radiation. All~     patients will undergo quantification of breast density by MRI at baseline 1, baseline 2~     (after 3-month observation period) and after 3 and 6 months on denosumab, which means after~     0, 3, 6 and 9 months after entering the study. Because the therapeutic agent is an injectable~     drug, the investigators will conduct a single arm study with both pre- and post-treatment~     measurements to determine the extent of variability in breast density over time and a placebo~     treatment period or group will not be utilized. This is an investigator initiated trial and~     Amgen (SPONSOR) will provide the trial drug denosumab.~   "
72850|NCT02613403|"~     This is a randomized, multicenter, 2-part, open-label trial of the combination regimen of~     grazoprevir (GZR [MK-5172]; 100mg), uprifosbuvir (UPR [MK-3682]; 450 mg) and ruzasvir (RZR~     [MK-8408]; 60 mg) with and without Ribavirin (RBV) in cirrhotic (C) or non-cirrhotic (NC)~     participants infected with hepatitis C virus (HCV) previously failing a direct-acting~     antiviral regimen (DAA). The combination regimen, referred to as MK-3682B, will be~     administered as two fixed-dose combination (FDC) tablets, given once-daily. The study will~     evaluate the efficacy of MK-3682B with or without RBV as assessed by the proportion of~     participants achieving Sustained Virologic Response 12 weeks (SVR12) after the end of all~     study therapy.~   "
72851|NCT02613390|"~     The goal of this clinical research study is to learn about the safety and accuracy of using~     MRI as a guidance system during laser ablation surgery of tumors that have spread to the~     spine.~   "
72852|NCT02613377|"~     Transfusions cause more adverse events in children than in adults. Patients in pediatric~     intensive care units (PICU) are particularly exposed to transfusions of plasma-rich blood~     products (red blood cell (RBC), plasma and platelets) and the risk of adverse events after a~     transfusion is particularly high in this vulnerable population. Transfusion-related acute~     lung injury (TRALI), an acute inflammation of the lungs that impairs gas exchange leading to~     acute respiratory failure, is one of the 2 most deadly transfusion complications in the~     general population. There is limited evidence on TRALI incidence and impact in critically ill~     children. This reduces the awareness of PICU team for this complication, and makes the~     decision process to transfuse particularly difficult. Moreover, acute lung injury is highly~     prevalent in critically ill children. It is therefore complex to ascertain if the high~     frequency of respiratory deteriorations observed after a transfusion in PICU is explained by~     the transfusion itself or by the evolution of the patient's critical illness.~      The investigators will conduct a cohort study of consecutive transfused critically ill~     children, with a control group of matched non-transfused children. The primary objective is~     to determine if transfusion of RBC, plasma and/or platelets in PICU is an independent risk~     factor of TRALI, and to compare the respiratory evolution in the two matched (transfused and~     non-transfused) groups. The secondary objectives will include the determination of the~     incidence rate, risk factors and clinical impact of TRALI in transfused PICU patients. The~     investigators will study both classic TRALI and delayed TRALI.~   "
72853|NCT02613364|"~     This randomized phase III trial compares yoga, survivorship health education program, and~     cognitive behavioral therapy in reducing sleep disturbance (insomnia) in cancer survivors.~     Insomnia can be described as excessive daytime napping, difficulty falling asleep, difficulty~     staying asleep, or waking up earlier than desired. Insomnia can increase fatigue, impair~     physical function, impair immune function, cause circadian rhythms (known as the biological~     clock) to be disrupted and decrease quality of life. Yoga may improve circadian rhythms,~     physical and immune function, and improve insomnia and sleep quality in cancer survivors. It~     is not yet known whether yoga is more effective at treating insomnia than a health education~     program or cognitive behavioral therapy program.~   "
72854|NCT02613351|"~     The aim of this study is to determine if: the large muscles of the leg, activated during~     walking, are also active during scooting; whether scooting alters the relationship between~     leg and breathing heaviness; whether there is evidence of leg fatigue during scooting.~   "
72867|NCT02613182|"~     The rationale for this study is to provide additional treatment with NEOD001 for subjects who~     complete Study NEOD001-001, and to continue to evaluate long term safety and tolerability.~     All subjects in the current NEOD001 trials are being dosed at 24 mg/kg, which will be~     continued in this study.~   "
72868|NCT02613169|"~     Randomized controlled trial (RCT) of isoniazid (INH) vs. no INH to prevent Mycobacterium~     tuberculosis infection in HIV-exposed uninfected (HEU) infants.~   "
72869|NCT02613156|"~     This study is aiming to evaluate the clinical efficacy of complete laparoscopic resection of~     recurrent hepatocellular carcinoma (HCC).~   "
72870|NCT02613143|"~     The purpose of this study is to assess the zonulo-hyaloido-vitrectomy for malignant glaucoma~     through an anterior approach.~   "
72855|NCT02613338|"~     A better understanding of knee joint kinematics is important to explain the premature~     polyethylene wear failures within total knee arthroplasties (TKAs) and to help design a~     prosthesis that most closely approximates the normal knee. Specifically, posterior~     stabilizing (PS) knees have been found to be associated with lower amounts of posterior~     femoral rollback, higher occurrence of reverse axial rotation and increased amount of~     condylar lift-off. The DePuy Synthes Joint Reconstruction's Attune PS fixed bearing (FB) knee~     system has incorporated subtle changes in its design to address restoration of kinematics~     that more closely resemble those of a normal knee. To understand if this design is able to~     effectively restore kinematics in the implanted knee, further in vivo analysis is necessary.~     This continuation of the study will analyze 30 subjects with the Attune PS FB 3 months~     post-operatively using the University of Tennessee's mobile fluoroscopy unit while performing~     three daily activities, level walking, ramp down and deep knee bend.~   "
72856|NCT02613325|"~     The investigators propose the use of functional photoacoustic microscopy (fPAM) to evaluate~     both benign and malignant pigmented lesions for tumor depth. Through fPAM analysis followed~     by histological examination, the investigators anticipate that they will be able to~     non-invasively determine tumor depth of pigmented lesions (moles and melanoma). In melanoma,~     tumor depth (Breslow's depth) is not only an important prognostic indicator, but also directs~     surgical treatment. The ultimate goal is to develop a sensitive clinical tool that will allow~     non-surgical evaluation of pigmented lesions, which eventually, will aid in melanoma~     diagnosis and management - potentially an earlier and more definitive surgical management.~      In addition, the investigators propose to use the combination of fPAM and single-cell PAM to~     respectively image CTCs in trunk vessels and cuticle capillaries. Based on the investigators'~     murine models, the investigators anticipate that they will be able to differentiate CTCs from~     other blood cells and reliably calculate CTC concentration in a non-invasive manner. CTC~     concentration has been demonstrated to be a valuable indicator of a melanoma's metastatic~     potential and a potential tool in evaluating treatment efficacy. The ultimate goal is to~     develop a sensitive imaging device that will allow accurate evaluation of the risk of~     melanoma recurrence and metastases, that may facilitate treatment monitoring.~   "
72857|NCT02613312|"~     The purpose of this study is to determine the response rate and overall survival in patients~     that have been diagnosed with mesothelioma and will undergo chemotherapy, surgery and~     intensity modified radiation therapy (IMRT) as part of their standard of care.~   "
72858|NCT02613299|"~     The purpose of this study is to determine whether radiation therapy decreases tumor size and~     tumor spread. The investigators will consent subjects that have been diagnosed with~     mesothelioma and will undergo radiation therapy followed by surgical resection as their~     standard of care. The investigators will collect data from past and future medical records as~     well as data regarding their health status for their lifetime by reviewing life status,~     treatment status and CT scans.~   "
72859|NCT02613286|"~     This study is an open-label, multicenter, randomized, phase II non-inferiority trial (proof~     of concept study). Its purpose is to evaluate the safety and efficacy of extrafascial~     hysterectomy plus pelvic-lymph node dissection compared with the standard modified radical~     hysterectomy in patients with stage IA2-IB1 cervical cancer ≤ 2cm.~   "
72860|NCT02613273|"~     This Phase II, open-label, three-arm randomized controlled trial (RCT) will investigate the~     effects of 12 weeks of supervised aerobic exercise vs. 12 weeks of supervised resistance~     exercise vs. usual care in men with metastatic castration resistant prostate cancer to~     determine the safety, feasibility, and tolerance of exercise; quality of life indicators, and~     a prognostic score.~   "
72861|NCT02613260|"~     Uptake of colorectal cancer (CRC) screening is suboptimal in the San Francisco Health Network~     and access to care may be limited so novel models of health care delivery are warranted. The~     objective of this study is to examine whether a centralized panel management model with~     mailed fecal immunochemical test (FIT) will be effective at increasing the uptake of CRC~     screening and could be developed and sustained within the typical parameters of~     cost-effectiveness and budget impact analyses.~   "
72862|NCT02613247|"~     Patellofemoral pain syndrome (PFPS) is the most common overuse injury seen in the athletic~     population, particularly amongst runners. The standard of care treatment for PFPS is a~     comprehensive active rehabilitation program. Eighty percent of patients with PFPS report~     improvement in their symptoms with such a program. Unfortunately, the remaining twenty~     percent fail to achieve adequate symptom relief with rehabilitation alone. Considering the~     enormous number of individuals running for fitness, PFPS represents a significant challenge~     to public health as the investigators strive to encourage active living in our society.~      A relationship between PFPS and the development of patellofemoral osteoarthritis (PFOA) has~     been suggested in scientific literature. Given that intra-articular viscosupplementation~     (hyaluronic acid) injections have shown clinically significant symptom improvement in knee~     osteoarthritis, and PFPS is likely on the same spectrum, the investigators propose a trial~     for therapy-resistant PFPS.~      Hyaluronic acid is a naturally occurring molecule found in the synovial fluid of freely~     movable joints (such as the knee). It is believed to contribute to lubrication and cushioning~     in these joints. The composition of synovial fluid within arthritic joints is altered,~     resulting in reduced fluid viscosity and elasticity. One modern formulation of hyaluronic~     acid is Hylan G-F 20 (Synvisc-One, Sanofi Canada). This treatment is offered as a single~     injection and will be utilized in this clinical trial.~   "
72863|NCT02613234|"~     The prevalence of epilepsy is about 0.5% to 1% worldwide, with high disability and mortality~     rate. The 128-channel electroencephalograph (EEG), combined with BESA dipole localization~     method, is able to provide more specific information about the brain activity and find out~     the epileptogenic focus. Based on this novel EEG recording method, cathode transcranial~     direct current stimulation (tDCS) targeting the epileptogenic focus can be used to decrease~     the excitability of the cortex, thus reducing the frequency of seizures. A single-center~     single-blinded randomized controlled and open-label extension trial will be carried out to~     study the efficacy of 128-channel electroencephalograph combined with BESA dipole~     localization method and Intervention on brain waves for epilepsy.~   "
72864|NCT02613221|"~     To evaluate the combination of panitumumab and TAS-102 in patients with RAS wild-type~     metastatic colorectal cancer (CRC) refractory to standard chemotherapy (oxaliplatin,~     fluoropyrimidines, irinotecan and anti-VEGF therapy).~   "
72872|NCT02613117|"~     This study will assess the oral tolerability and immediate post-treatment safety of topical~     application for two marketed oxalate products as initial care in dental patients to treat or~     prevent tooth sensitivity pain that may be attributed to dentinal hypersensitivity.~   "
72873|NCT02613104|"~     Previous research suggests that people with bipolar disorder have trouble accurately~     identifying emotions. The goal of this study is to test a novel intervention, emotion~     recognition modification (ERM), to help improve the ability of young people with bipolar~     disorder to identify emotions.~   "
72874|NCT02613091|"~     In a1972 study in the French Annals of Pharmaceuticals, Laroche and Laroche reported that the~     drug clemastine has a negative effect on patients' color discrimination, which is the ability~     to distinguish different hues and arrange them in the correct order. In an upcoming clinical~     trial studying the effect of clemastine on vision outcomes, our lab aims to assess color~     visual performance adding assessment of color defectiveness as a clinical endpoint. Color~     defectiveness is the ability to see certain colors, and is commonly referred to as~     color-blindness. Color discrimination and defectiveness can be related, but do not always~     correlate. This study aims to detect the effect, if any, that clemastine has on color~     defectiveness in healthy controls, which could confound its use as an outcome endpoint in~     future clinical trials relating to clemastine.~   "
72875|NCT02613078|"~     Current study aims to investigate the influence of gut-directed hypnotherapy and probiotic~     nutritional supplement (SymbioLact B) on gastrointestinal symptoms in children with~     functional abdominal pain or irritable bowel syndrome compared to self-observation only. The~     study also includes collection of psychometric data (emotional and behavioral problems, pain~     coping strategies), data on activity of the autonomous nerve system as measured by heart rate~     variability and data on stress response (saliva cortisol levels).~   "
72876|NCT02613065|"~     The purpose of this project is to determine if protein is less likely to create positive~     energy balance when added to the diet compared to carbohydrate. To do this, the investigators~     will take detailed measurements of participant's baseline metabolic rate to understand their~     energy requirements. Then, the investigators will feed participants all their meals for two~     weeks, Monday-Friday, and measure their food intake. During one of the week-long feeding~     periods, participants will consume a shake made of egg protein that is ~20% of their energy~     requirements. During the other week, participants will consume a shake made of carbohydrate~     that is ~20% of their energy requirements. Participants will drink the assigned shake at the~     beginning of each of their daily three meals, and then they will be offered a 'regular' meal~     of unlimited quantity. Participants will not know that the investigators are measuring the~     food consumed after drinking the shake. Participants will drink the protein shake for the~     first week and carb-based shake for the second week, and vice versa-- depending on the~     randomization order. To account for energy expenditure, participants will wear an activity~     monitor, an accelerometer. Energy balance, measured as participant energy intake minus energy~     expenditure, will be our main outcome for each treatment. However, because participants may~     change their behavior if made aware of the true research question, the investigators will~     tell participants that the purpose of the study is to see how low fiber and high fiber shakes~     affect mood. The hypothesis is that during the week when participants consume the protein~     shake, they will remain in energy balance, but during the week of carbohydrate shake~     consumption, participants will have positive energy balance.~   "
72877|NCT02613052|"~     This is a prospective, randomized, controlled study to determine if albumin and propofol or~     albumin only will provide superior qualitative contrast enhancement during TEE bubble studies~     compared to agitated saline. Each patient will receive three randomized bubble studies~     (agitated saline, albumin, and albumin and propofol) using 10 ml of agitated contrast agent.~     The albumin and propofol mixture will consist of 7 mL of 5% albumin plus 3 mL of propofol (10~     mg/mL). Each patient will undergo qualitative review of all 3 bubble studies by 10 different~     anesthesiologists and/or cardiologists credentialed to read echocardiographic studies at the~     time of the surgical procedure, and also with retrospective review of the echo video (~200~     studies). A bicaval view will be obtained to record a 20 beat loop for each bubble study.~     Hemodynamic variables prior to injection of contrast agent; and 30 seconds, 1 minute and 2~     minutes after injection will be monitored and recorded.~   "
72878|NCT02613039|"~     Oral contraceptives (OCs) ameliorate hyperandrogenism and regulate menstrual cycles. To~     reduce androgenic side effects of first- and second-generation progestins, several new~     progestins derived from progesterone or spironolactone have been developed in the last few~     decades. These progestins, such as drospirenone, cyproterone acetate and NOMAC, are designed~     to bind specifically to the progesterone receptor and to have no androgenic, estrogenic or~     glucocorticoid actions.~      However, OCs with a more pronounced anti-androgenic effects are more likely to induce sexual~     dysfunction, mainly hypoactive sexual desire disorder, which can highly impact patient and~     partner's quality of life. Moreover, available data indicate that OC use might increase~     adiposity in adolescents and might be associated with central redistribution of body fat in~     young women with Polycystic ovary syndrome (PCOS) without a recognizable difference in~     clinical anthropometric measurements, including body mass index and waist circumference.~      In this context, it would be worth to evaluate the effects of combined OCs on metabolic and~     sexual health (sexual desire, arousal, and other parameters of sexual health), body image and~     mood.~   "
72879|NCT02613026|"~     The purpose of this study is to compare the short-term and long-term efficacies and the~     safeties of pirarubicin plus docetaxel(AT group) and pirarubicin plus cyclophosphamide~     followed by docetaxel(AC-T group) in neoadjuvant chemotherapy of breast cancer.~   "
72880|NCT02613013|"~     This is a 10-centre randomized controlled clinical trial to explore whether laser peripheral~     iridoplasty (LPIP) plus laser peripheral iridotomy (LPI) is more effective than single LPI to~     control the progression of primary angle closure with multi-mechanism based on the UBM~     classification.~   "
72893|NCT02612844|"~     This trial is conducted in Europe. The aim of the trial is to investigate the Safety,~     Tolerability,Pharmacokinetics (the exposure of the trial drug in the body) and~     Pharmacodynamics (the effect of the investigated drug on the body) of subcutaneous~     NNC0143-0406 A 0.6 mmol/L in Subjects with Type 1 Diabetes~   "
72894|NCT02612831|"~     The creatinine clearance will be measured using two consecutive 24 hour urine collections,~     with the objective of minimizing errors due to poor quality urine collection.~      The GFR will be measured by a reference method, because its estimation from blood creatinine~     levels (eGFR) by the MDRD study formula may be confounded by variations in muscle mass, and~     therefore creatinine production, following bariatric surgery. The method will remain the same~     in each center, and therefore consistent for any given patient, throughout the duration of~     the study. The GFR measurements will be performed after stopping any medication blocking the~     RAAS, and reducing diuretics for one week, with the introduction or increase of~     alpha-blockers or centrally-acting hypotensive agents. If it is impossible to stop~     RAAS-blockade (heart failure), the dose will at least be reduced for one week. This~     precaution is required to minimize the bias of functional renal insufficiency because the~     state of extracellular hydration is difficult to assess in obese subjects. Subsequent~     measurements of GFR will be performed in the same way.~      The choice of the tracer to measure GFR may vary according to study center. 51Cr-EDTA,~     99Tc-DTPA, iohexol or inulin may all be utilized. Because the assessment of edema is~     hazardous in extremely obese patients and because kidney disease favors edema formation, the~     simplified single injection method and the determination of plasma clearance measurement of~     the tracer is not reliable . Only the constant infusion method will be used to measure GFR.~     Briefly, GFR will be determined by calculating the glomerular clearance (Cl) from plasma~     concentrations (P) and renal excretions per unit of time (UxV) during infusion at a constant~     plasma level of the tracer (Cl=UxV/P). The result will be given as mean value of several~     consecutive clearances. Because correct urine collection is key for the procedure, seven~     collection periods (instead of 5 usually) will be performed for the calculation of the mean~     clearance. Bladder catheterization will be used only when it can be anticipated that the~     patient will not void satisfactorily. In the last 30 consecutive patients with mGFR below 60~     ml/min/1,73m2, this occurred twice and the subjects were 70 and 79 years old. Therefore, this~     might occur exceptionably in the study. Raw data from each center will be sent to the~     coordination center (Nice) to examine and validate the calculation of mean clearance values.~     To that aim, extreme and non-representative clearances will be excluded. At least 3 of the 7~     periods will be taken into account to calculate the mean values. For instance, in the last 30~     consecutive patients with mGFR below 60 ml/min/1,73m2, investigators considered on average~     4.7 periods and obtained a mean non-indexed GFR value of 40,7 ± 2,5 ml/min.~      Primary assessment will be performed at one year, as a previous study has already suggested a~     significant benefit within this period [66], and because surgery can't be delayed further in~     these patients strongly expecting the intervention, but follow-up will be extended to three~     years or until the end of the study, in order to document whether the initial benefits of~     surgical intervention are maintained.~        -  A reduction in the absolute value of measured GFR (mGFR) following bariatric surgery is~          expected in the first six months after surgery (M0 - M6). However, the weight loss may~          allow an increased in mGFR indexed to body surface area up until M6, and above all~          towards M12.~        -  the investigators expect a subsequent stabilization of mGFR between M12 and M36 in the~          bariatric surgery group, and will seek to measure the anticipated reduction in mGFR in~          the control group who remain in a state of glomerular hyperfiltration.~      All relevant cardiovascular, metabolic and nutritional parameters necessary to study the~     risk/benefit ratio of the intervention will be analyzed.~        -  Primary: bariatric surgery slows the progression of chronic kidney disease in the obese.~        -  Secondary: bariatric surgery improves survival, cardiovascular prognosis, metabolic,~          nutritional and inflammatory parameters, quality of life, and access to transplantation~          in the sub-group of patients whose GFR < 20ml/min/1.73m2 at inclusion, and there could~          be a chance loss for the patients in delaying surgery by one year.~   "
85843|NCT02443415|"~     The purpose of this study is to assess brain and memory changes in patients with uncontrolled~     diabetes (a condition called diabetic ketoacidosis (DKA))~   "
72881|NCT02613000|"~     Importance of gastrointestinal (GI) function in critically ill patients has been recognized,~     but until now there is no validated clinical tool to monitor GI dysfunction as part of~     multiple organ dysfunction syndrome (MODS). The general aim of current project is to develop~     a five grade score (0-4 points) for assessment of GI function similar to SOFA sub-scores used~     for assessment of other organ systems. 500 consecutive adult patients admitted to the~     intensive care unit will be monitored for gastrointestinal symptoms, intra-abdominal pressure~     (IAP) and acute gastrointestinal injury (AGI) grades [1]. In 200 patients from these, plasma~     and urinary levels of possible biochemical markers of intestinal injury will be assessed.~      Objectives:~        -  To determine the prognostic value of gastrointestinal symptoms alone and in combination~          with intra-abdominal pressure (IAP), and acute gastro-intestinal injury (AGI) grades in~          predicting the ICU-, 28 days and 90 days mortality of adult intensive care patients~          (Part A of the study)~        -  To describe the blood and urine levels of biochemical markers of intestinal injury in~          general cohort of intensive care patients (Part B of the study).~        -  To compare the prognostic values of the intestinal-specific plasma parameters (IFABP,~          citrulline, ILBP, and D-lactate) with the gastrointestinal symptoms, AGI grades, and the~          SOFA score in predicting of ICU-, 28 days and 90 days mortality of adult intensive care~          patients (Part B of the study) Study design: prospective, observational, multicenter~          study Patient population: All consecutive adult critically ill patients (25 to 50~          patients for each study site, 500 patients in total) in need for intensive care~          admission during maximum 4 weeks of study period.~      Duration of the study: for the individual patient 7 days and follow-up of 90 days Primary~     study outcome: 28 and 90 days all-cause mortality Secondary outcomes: ICU and hospital~     mortality, ICU length of stay, hospital length of stay, duration of mechanical ventilation,~     multiple organ failure as a cause of mortality, plasma and urinary levels of intestinal~     fatty-acid binding protein (I-FABP), citrulline, ileal lipid binding protein (ILBP), and~     D-lactate in general cohort of intensive care patients.~   "
72882|NCT02612987|"~     Insomnia is a commonly reported comorbidity for adolescents with psychiatric conditions. It~     is well-known that insomnia can exacerbate the concurrent psychiatric symptom load. Treatment~     of insomnia has been extensively examined in adults, but studies with adolescents are sparse.~     The purpose of this pilot study is to assess the feasibility and efficacy of internet-based~     cognitive behavioral therapy for insomnia (iCBT) in outpatients of Children and Youth~     Psychiatry. Twenty-one adolescents will be recruited and receive 7 weeks of iCBT. Outcome~     will be measured at pre treatment, at post treatment and at a three months follow-up. Weekly~     assessments will also be made during treatment on primary outcome and a presumed process~     variable constructed for the purpose of this trial.~   "
72883|NCT02612974|"~     This study has been designed to conduct as Randomized comparative clinical study.~   "
72884|NCT02612961|"~     A long-standing intervention during tracheostomy tube suctioning in acute care settings is~     use of saline to loosen and remove respiratory tract secretions, maintain airway patency, and~     prevent mucus plugs. Controversy exists regarding safely using saline prior to suctioning for~     head and neck cancer and mechanically ventilated patients. To date, all studies had~     methodological limitations. In 2013, the clinical consensus statement published by AAO-HNSF~     identified a research gap based on lack of strong scientific evidence. A single site,~     randomized controlled pilot study will be conducted to evaluate effects of saline~     instillation with tracheostomy tube suctioning; test feasibility of proposed methods and~     procedures; and ensure proposed outcome variables are measurable and not confounded by~     extraneous variables. Institutional review board approval will be obtained before eligible~     adult subjects (inpatient and intensive care units) are recruited and consented. Oxygen~     saturation and heart rate are primary outcome variables; secondary outcome variables are~     mucus plugs and ventilator-associated pneumonias; other demographic data and patient~     characteristic variables; and outcome variables on complications and length of stay. Mean,~     standard deviation, median, and interquartile range will be calculated for continuous~     variables using t-tests to compare pre- and post-assessment scores. Frequencies and~     percentages will be calculated for categorical variables using Chi square and Fisher Exact~     tests to compare pre- and post-assessment scores. Multiple regression analysis will be used~     to control for confounding variables. This study is innovative as the first to recruit both~     head and neck cancer patients and mechanically ventilated patients and to measure all major~     outcomes of interest in one study. Understanding the effects of normal saline instillation~     will enable development of evidence-based guidelines and standardized protocols for~     tracheostomy tube suctioning.~   "
72885|NCT02612948|"~     Scheduled, low-dose quetiapine is effective in preventing delirium in high-risk critically~     ill, trauma/surgical patients. Prophylaxis also reduced ventilator duration and ICU length of~     stay.~   "
72886|NCT02612935|"~     In collaboration with the Mercy MS Achievement Center, Lumos Labs is proposing an open-label,~     12-month pilot study of computerized cognitive training as part of the cognitive wellness~     program in order to evaluate (1) the user experience of Lumosity in individuals with MS, and~     (2) the efficacy of Lumosity for improving cognitive outcomes in individuals with MS.~   "
72887|NCT02612922|"~     Trial to evaluate efficacy and safety of nitazoxanide (NTZ) in the treatment of acute~     uncomplicated influenza.~   "
72888|NCT02612909|"~     The purpose of this study is to determine a safe and effective dose of IVAC A/H5N1 vaccine~     for licensure in Vietnam. The first phase (Phase 2) will compare two doses of the vaccine.~     Based on the outcome of the Phase 2, the Vietnam MOH will determine if Phase 3 can be~     conducted.~   "
72889|NCT02612896|"~     Taenia solium taeniosis/cysticercosis is a neglected zoonotic parasitic disease complex with~     significant economic and public health impacts, occurring primarily in developing countries.~     Humans are the carriers of the tapeworm (taeniosis); the normal intermediate pig host~     develops the metacestode larval stage (porcine cysticercosis). However, people can also act~     as accidental intermediate hosts and develop human cysticercosis or neurocysticercosis (NCC)~     when the central nervous system is involved.~      The scattered efforts of researchers into evaluation of control programmes in Sub-Saharan~     Africa (SSA) have focussed on single control options. It is becoming clear that these~     stand-alone options have the potential to reduce the occurrence of the parasite, however~     either long term or more integrated efforts seem to be required to reach an elimination~     status.~      The objective of the current study is to evaluate the cost-effectiveness/acceptability of~     elimination (to be achieved on a short term via integrated measures), and control (single~     measures, with an elimination goal on a longer term) of T. solium in a highly endemic area in~     SSA.~      This intervention study will entail an elimination study arm in which multiple control~     options are combined (integrated) aiming at the final human host (Mass drug administration~     (MDA) and health education) and pig intermediate hosts (pig treatment and vaccination). In a~     second study arm a single control option will be carried out (pig treatment). In both study~     arms (health) education will be implemented. At baseline and in the final sampling year,~     prevalence of human taeniosis/cysticercosis and porcine cysticercosis will be determined in~     all study villages. Active ongoing surveillance and 6 monthly (biannual) human and pig~     sampling will be conducted in the elimination study arm, as well as two-yearly (biennial)~     sampling of the pig intermediate host in the control study arm. Additionally, (open ended)~     questionnaires and focus group discussions will be administered/held to obtain data on the~     cost of pig keeping, T. solium, the interventions and the perception/acceptability of the~     proposed control measures to the local communities.~   "
72890|NCT02612883|"~     Tissue perfusion is a critical factor for tissue regeneration and healing of anastomoses.~     Compromised microperfusion in the area where the anastomosis is sited likely contributes to~     leaks, but until now there has not been an easy and reliable technique to intraoperatively~     evaluate microperfusion.~      Objectives: To assess the association of intraoperative flux measurement with postoperative~     outcome of patients undergoing major abdominal surgery.~      Trial design: Prospective observational study. Flux measurement will be carried out using the~     moorVMS-LDF DUAL CHANNEL Laser Doppler Blood Flow system. The flux probe will be applied on~     the respective organs (i.e. esophagus, stomach, liver, pancreas, colon, rectum) and~     measurements will be documented after a stable signal has been obtained.~   "
72891|NCT02612870|"~     Patients with breast cancer normally undergo a labelling with radioactive tracer typically 1~     day before surgery, which enables the surgeon to localize the sentinel lymph node during~     surgery. This pilot study uses the magnetic Sentimag technique to mark the lymph nodes either~     1 or 4-6 days before surgery to investigate the concordance with the standard technique.~   "
72895|NCT02612818|"~     Thus is a longitudinal, prospective, multicentric observational study performed in mainland~     France, among a sample of gynaecology surgeons practising at endometriosis expert centres.~      The aim of this study is to describe, under real treatment conditions in patients suffering~     from endometriosis, the impact of the use of anti-adhesion treatment during celioscopy~     surgery on the development of clinical signs in the patients and their fertility at one year.~   "
72896|NCT02612805|"~     This study evaluates the effects of the combined exercise training (aerobic more resistance)~     and of the aerobic exercise training isolated compared to control group, which performed only~     stretching and relaxation, in the treatment of type 2 diabetes (T2DM). The two exercise~     interventions and the control procedure are performed in aquatic environment.~   "
72897|NCT02612792|"~     The present study was designed to explore the effectiveness of PRF combined with 1.2% ATV gel~     in treatment of mandibular degree II furcation defects in comparison to PRF and open flap~     debridement (OFD) alone.~   "
72898|NCT02612779|"~     Study of elotuzumab in combination with pomalidomide and low dose dexamethasone (EPd Cohort)~     and elotuzumab in combination with nivolumab (EN Cohort) to assess the safety and efficacy of~     these combination therapies for treatment of relapsed or refractory MM patients.~   "
72899|NCT02612766|"~     The purpose of this study is to determine the safety and tolerability of oats in gluten free~     diet.~   "
72900|NCT02612753|"~     Aphasia is a frequent symptom after a left hemisphere stroke. It has serious impacts on~     social, family and professional lives. Aphasic patients need to be rehabilitated. To date, no~     pharmacological treatment being available only speech and language therapy (SLT) can improve~     patients, but its efficiency is moderate. Several studies have investigated the link between~     the recovery of language and neural reorganization. tDCs, a noninvasive technology for~     modulating neural excitability, could potentiate the effects of the SLT. About 25 studies in~     literature have described beneficial effects of tDCs coupled with SLT on aphasic patients.~     However to the investigator knowledge the feasibility of tDCs and speech therapy in clinical~     pathways has never been investigated. That is why the investigator propose to study in real~     care conditions how SLT proves more efficient on the recovery of language in a discursive~     assessment when coupled with active stimulation than with placebo stimulation.~   "
72901|NCT02612740|"~     The aim of this study was to evaluate the effect of the use of deproteinized bovine bone as a~     filler material of critical-sized (diameter >=20 mm) bony defects derived from the excision~     of maxillary and mandibular cysts. 20 patients were considered.~      Patients were randomly divided into 2 groups according to the type of treatment: the bone~     defect was filled with granules of deproteinized bovine bone (test); no filling material~     (control). Clinical parameters were recorded at 7 days, 1, 6 and 12 months after surgery.~     Radiological follow up consisted of an orthopantomograph and a CT scan taken at the baseline~     (pre-operatory) and 12 months after surgery.~      In order to evaluate the difference in percentage of filling of the bone defect between the~     two groups, the pre-op and the 1-year radiolucent volumes were evaluated in the CT scans.~   "
72902|NCT02612727|"~     At present, much of sub-Saharan Africa, including Nigeria and other resource-limited~     countries, are without ready access to CPT, due to factors including the lack of PT devices,~     which are expensive and require consistent electric power to operate. NHB is a significant~     cause of neonatal morbidity and mortality, but preventable when appropriate treatment is~     initiated. We have shown that FS-PT is safe and efficacious for the treatment of~     mild-moderate NHB. The major goal of this study is to demonstrate that FS-PT is efficacious~     for the treatment of significant/severe NHB, generally defined as TB of ≥12-14mg/dL (but more~     specially as defined as needing phototherapy per American Academy of Pediatric 2004~     guidelines). It will be done at 3 sites in Nigeria (2 in Lagos, Nigeria and 1 in Ogbomoso,~     Nigeria). The rationale for conducting the study is that in Nigeria, and other countries that~     cannot afford effective commercial light devices and/or have no reliable electric power to~     operate them, filtered sunlight phototherapy might offer a safe and effective treatment for~     neonatal jaundice.~   "
72903|NCT02612714|"~     Statins may decrease serum testosterone levels via decreasing cholesterol. This longitudinal~     study detected the effects of rosuvastatin on free testosterone levels and sexual function in~     men with type 2 diabetes.~      Methods:~      Investigator enroll 150 men with type 2 diabetes and hypercholesterolemia. Biochemical~     assessments include serum total cholesterol (TC), low-density lipoprotein (LDL), high-density~     lipoprotein, triglyceride, prolactin, thyroid-stimulating hormone, luteinizing hormone,~     follicle stimulating hormone, total testosterone and serum sex hormone binding globulin~     (SHBG). All parameters are measured before statin treatment, after 6 months of statin~     treatment and 6 months after discontinuing statin treatment. Scores of the sexual health~     inventory for men (SHIM) are also evaluated.~   "
72904|NCT02612701|"~     E-cigarettes deliver nicotine by creating an aerosol of ultrafine particles. Many questions~     remain about the size and composition and especially about the potential toxicity of these~     particles. Thus, a key unanswered question—and the research question proposed—is whether~     e-cigarette aerosol triggers the same acute impairment in coronary microvessel function as~     does conventional cigarette smoke, which delivers a very well-defined exposure to fine~     particles and many fold greater exposure to toxic (combustion) products including volatile~     organic compounds (such as acrolein) that have been implicated in the pathogenesis of~     tobacco-related coronary disease.~      Because the effects of nicotine on the human coronary microcirculation remain incompletely~     defined—with multiple potential vasodilator and vasoconstrictor actions each of which may~     vary by dose—we will determine the comparative effects of conventional cigarette smoke~     against e-cigarette aerosol with no nicotine, with low-dose nicotine, and with high-dose~     nicotine.~   "
72905|NCT02612688|"~     This is a pragmatic cluster-randomized control trial (RCT) of an Advance Care Planning (ACP)~     Video Program for nursing home (NH) patients ≥ 65 years old who are cared for in 360 NH~     facilities (intervention arm n=119; control arm n=241) within two NH health care systems:~     Genesis HealthCare and PruittHealth. The intervention NH facilities will implement the ACP~     Video Program, while the control NH facilities will follow their usual ACP procedures. The~     trial will evaluate the effectiveness of the ACP Video Program by comparing hospitalizations,~     advance directives, and hospice use in the intervention vs. control NHs.~   "
72906|NCT02612675|"~     This will be a randomized, cross-over study of two oral nutrition supplements in individuals~     with Type 2 Diabetes.~   "
72909|NCT02612636|"~     Sleep is a complex physiologic and behavioral process essential for rest, repair, well-being,~     and survival. Sleep is defined as a periodic, reversible state of cognitive and sensory~     disengagement from the external environment. Critically ill patients experience poor sleep~     quality. Surveys of ICU survivors have shown that sleep disruption, pain and intubation for~     mechanical ventilation are the major sources of anxiety and stress during the ICU stay. Many~     physiological, psychological and environmental factors contribute to the incidence of sleep~     disruption for the ICU patients. The primary physiologic factors documented in the literature~     are pain, medications and illness.The primary psychological factors documented in the~     literature are stress and worry. Environmental factors include noise, patient care activities~     and therapeutic modalities as mechanical ventilation. Our research aim will be the impact of~     effective interventions like use of ear plugs and eye mask on decreasing light exposure and~     promoting sleep in ICU patients.~   "
72910|NCT02612623|"~     This is an 8-week randomized, parallel, double-blind, placebo-controlled study of gefapixant~     (AF-219) in subjects with refractory chronic cough.~   "
72911|NCT02612610|"~     This study is designed to evaluate the efficacy of three dose regimens of gefapixant~     ([MK-7264] 7.5 mg, 20 mg, and 50 mg) relative to placebo in reducing awake objective cough~     frequency. The primary hypothesis for this trial is that at least one dose regimen of~     gefapixant is superior to placebo with respect to the mean change from baseline in awake~     cough frequency (on the log scale).~   "
72912|NCT02612597|"~     In this study the investigators would like to elaborate on the mechanisms that lead to a~     higher insulin sensitivity after exercise training and a lower insulin sensitivity after~     bedrest.~      The investigators speculate that the concomitant chances in blood volume during training and~     bedrest might explain the changed insulin sensitivity because with a changing blood volume~     also the dilution space of the glucose will change.~      Furthermore, the investigators would like to work on the influence of a changed capacity of~     skeletal muscle for glucose uptake and glycogen storage on the glucose sensitivity.~      Therefore, A) a bed rest study with healthy untrained subjects and B) a training study with~     obese pre-diabetic patients will be conducted.~   "
72913|NCT02612584|"~     For correct of presbyopia, in this study, the investigators have recruited subjects who aged~     45~65 years with presbyopia and do not have any other ocular disease(ex, ocular surface~     disease, corneal dystrophy, retinal disorders, etc.). All participants will underwent~     ophthalmic examination including manifest refraction, uncorrected distance visual acuity~     (UDVA), uncorrected near visual acuity (UNVA), corrected distance visual acuity (CDVA),~     corrected near visual acuity(CNVA), Goldmann visual field test, depth of focus Contrast~     sensitivity test, slit-lamp examination, topography with scheimp flug device(OCULUS pentacam~     ®) OSDI(ocular surface disease index) and Questionnaire about visual function and ocular~     symptoms. Apply pinhole soft contact lens (eyelike NoanPinhole ® , seoul, south Korea, Koryo~     Eyetech) on non-dominant eye of participants and/or soft contact lens for distance vision on~     dominant eye of participants. The investigators recommend use of pinhole contact lens at~     least 3 hours in a day for 1 week. And, participant will underwent the all ophthalmic~     examination same above 2 weeks after first apply of pinhole contact lens. The investigators~     will compare ophthalmic parameters mentioned above before and after wearing pinhole contact~     lens and evaluate the efficacy and safety of pinhole soft contact lens for correcting~     presbyopia.~   "
72914|NCT02612571|"~     The purpose of the present study is to compare rates of glaucomatous optic neuropathy in~     professional wind versus non-wind instrument players in the Philadelphia Orchestra. A~     secondary objective is to evaluate intra-ocular pressure and choroidal thickness of wind~     instrument players under variable playing conditions.~   "
72915|NCT02612558|"~     The purpose of this study is to evaluate whether fostamatinib is safe and effective in~     treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA).~   "
72916|NCT02612545|"~     Background:~      Malaria is an illness caused by a parasite that enters people s bodies when a mosquito bites~     them. It can cause fevers, headaches, body aches, and weakness. If not treated, it can make~     some people very ill. Malaria can be cured. A mix of 2 drugs that has worked well in the past~     is not working as well in some parts of Cambodia. Researchers want to see if a mix of 3 drugs~     works better and is safe.~      Objectives:~      To see if a 3-drug mix can be used to treat malaria in areas where a 2-drug mix is less~     effective.~      Eligibility:~      People aged 2 65 years with mild malaria in Pursat, Preah Vihear, and Ratanakiri Provinces in~     Cambodia.~      Design:~      Participants will be screened with medical history, physical exam, urine and blood tests, and~     an electrocardiogram (ECG). For this, electrodes will be placed on their skin to check their~     heartbeat.~      Participants will spend about 5 nights in the hospital. They will have physical exams and~     will complete symptom questionnaires daily. They will give blood periodically throughout~     their stay. For this, a thin plastic tube is placed in an arm vein for the first day, and~     blood draws using a needle are done after that.~      Participants will get either a 2-drug mix or a 3-drug mix for 3 days. They will have 2 ECGs~     each day of receiving the drugs.~      Participants will have follow-up visits once a week over 5 weeks. At these visits, they will~     have a physical exam and have blood taken. If they have any signs of malaria, they will be~     re-treated.~      The study will last up to 42 days.~   "
72917|NCT02612532|"~     The Lung Cancer Indicator Detection (LuCID) study investigates the the diagnostic accuracy of~     FAIMS for diagnosis of lung cancer by analysis of exhaled Volatile Organic Compounds.~   "
72918|NCT02612519|"~     Multicentre, open, randomised, and controlled trial conducted in patients diagnosed with~     recurrent/refractory ascites who meet inclusion/exclusion criteria. The efficacy of the~     Alfapump, TIPS and paracentesis with regard to the treatment of ascites will be compared. All~     patients will receive medical care for cirrhosis and ascites according to the institution's~     standards of care. Standard of care may include, but is not limited to the administration of~     diuretics, paracentesis and consideration for orthotopic liver transplantation.~   "
72919|NCT02612506|"~     To evaluate the safety and tolerability of Hepalatide(L47) and characterize the clinical~     pharmacokinetics in healthy volunteers.~   "
72920|NCT02612493|"~     Obesity is the indication for bariatric surgery in type I diabetes. Interestingly postsurgery~     the patients improve remarkable in their need for insulin, not only in the daily total~     insulin dosage but also in the dosage of IU per kg.~   "
85844|NCT02443402|"~     The purpose of this study is to compare sitagliptin and placebo for the prevention of high~     blood glucose during surgery.~   "
72921|NCT02612480|"~     Rationale:~      In patients suffering a myocardial infarction the P2Y12 receptor antagonists prasugrel and~     ticagrelor improve outcome and prognosis compared to clopidogrel. Moreover, ticagrelor lowers~     mortality from pulmonary infections and sepsis, which cannot solely be explained by its~     platelet-inhibiting effect. An effect on the inflammatory response in the setting of acute~     myocardial might underlie this phenomenon and if substantiated support a novel beneficial~     mechanism of the new the P2Y12 receptor antagonists.~      Objective:~      To study whether ticagrelor, added to acetylsalicylic acid, modulates the inflammatory~     response to the administration of lipopolysaccharide (LPS) in humans in vivo, and to compare~     this effect with the P2Y12 antagonist clopidogrel.~      Study design:~      Prospective randomized placebo-controlled trial, according to a PROBE design (prospective~     randomized open blinded-endpoint study).~      Study population:~      Forty healthy male volunteers aged ≥ 18 and ≤ 35 years. Intervention (if applicable):~     Participants will be randomized to receive either placebo (twice daily), acetylsalicylic acid~     (80 mg once daily, after a loading dose of 160 mg) + placebo (once daily), acetylsalicylic~     acid (80 mg once daily, after a loading dose of 160 mg) + ticagrelor (90 mg twice daily,~     after a loading dose of 180 mg) or acetylsalicylic acid (80 mg once daily, after a loading~     dose of 160 mg)+ clopidogrel (75 mg once daily, after a loading dose of 300mg).~      Main study parameters/endpoints:~      Endpoints: area under the curve of the proinflammatory cytokines TNF-alpha, IL6, IL-10, IL1ra~     IL-8, IL-1β, MCP-1 MIP-1a, MIP-1b en IFN; peak concentrations of the various cytokines;~     plasma concentration of HMGP1; platelet-monocyte complex formation and markers of platelet~     function; plasma concentration of adenosine.~   "
72922|NCT02612467|"~     Background Studies in the United Kingdom find the stratified care model of the STarT Back~     Tool (SBT) to be superior to usual care in primary care low back pain (LBP) patients.~     However, considerations on differences in health care and social systems across countries are~     required before taking steps towards any recommendations of implementing stratified care into~     other health care services.~      Objective To investigate the effectiveness of the stratified care model of the SBT, when~     embedded into the regional disease management programs on LBP in primary care as compared to~     current best practice care.~   "
72923|NCT02612454|"~     The primary objective of the study is to assess the long-term safety of dupilumab in~     pediatric participants with AD.~      The secondary objectives of the study are:~        -  To assess the long-term efficacy of dupilumab in pediatric participants with AD~        -  To assess the trough concentrations of functional dupilumab in serum and the~          immunogenicity in pediatric participants with AD after re-treatment with dupilumab.~   "
72924|NCT02612441|"~     Chinese Acupuncture can improve the motor ability of patients after having first acute~     ischemic stroke, in time scale up to 3 weeks from when the ischemic stroke occur and in~     minimum receiving number of 3 Acupuncture treatments.~      The accepted treatment on cerebral vascular accident (CVA) is focus on two lines: the first~     is the treatment when the stroke occurs, and the second is prevention from having more~     cerebral vascular accident in the future.~      In the first accepted treatment line, the only medicinal measure that stand up in critique of~     organized researches, is Tissue Plasminogen Activator (TPA), and there is Short and limited~     time after the CVA occur that it can be used. Also (TPA) can be used only on part of the~     patients with specific defined criterions.~      The aim of this study is to add a new accepted treatment method that appointed to improve the~     results of acute ischemic stroke by Chinese Acupuncture. The written works on this topic is~     unambiguously.~   "
72925|NCT02612428|"~     The primary objective of the study is to evaluate safety and efficacy of ELAD with respect to~     overall survival of subjects with a clinical diagnosis of alcohol-induced liver~     decompensation (AILD) through at least Study Day 91.~      The secondary objective is to evaluate the proportion of survivors at Study Day 91 using a~     chi-squared test.~   "
72926|NCT02612415|"~     A feasibility study to inform the design and conduct of a randomised controlled trial of high~     flow nasal cannula (HFNC) versus continuous positive airway pressure (CPAP) for non-invasive~     respiratory support in critically ill children~   "
72927|NCT02612402|"~     A smartphone app will be installed on smartphones of patients with type 2 diabetes or~     hematologic malignancies that do not exercise. The app will send SMS messages to encourage~     exercise. The exercise will be quantified by the smartphone accelerometer and clinical data,~     including HbA1c will be collected.~   "
72928|NCT02612389|"~     This study will explore the a Qigong based exercise intervention, here referred to as~     Meditative Movement (MM), to ameliorate the symptoms associated with chronic obstructive~     pulmonary disease (COPD) and its co-morbidities. It tests the hypothesis that MM will have a~     beneficial effect on COPD in FA, particularly on functional ability, respiratory symptoms,~     affective state, inflammation, and autonomic imbalance. If the hypothesis is correct, MM~     could be rapidly and inexpensively taught to FA with COPD and other COPD patients to slow~     degeneration and improve quality of life.~   "
72929|NCT02612376|"~     This study plans to establish a large bank of blood, cerebral spinal fluid (CSF), imaging,~     and clinical data. These data and samples will be used for future research into the causes of~     Alzheimer's disease (AD), Down Syndrome (DS) and other diseases that cause thinking and~     memory problems. This future research will also study how treatments for these diseases work.~     This research may help develop new treatments for some diseases of the nervous system and~     help understand these diseases better.~   "
72930|NCT02612363|"~     The investigators will conduct a prospective, single-center, randomized, double-blinded,~     controlled study to investigate the effect of early goal directed sedation on~     microcirculation in early septic shock patients.~   "
72943|NCT02612194|"~     Following informed consent and registration, subjects will undergo tissue pre-screen~     eligibility screening. Tumor specimens from potential subjects will then undergo c-MET and~     RON expression characterization. Eligible subjects will then undergo treatment eligibility~     screening and then be enrolled into available open molecularly defined cohorts. If at least~     one response is observed within a cohort, it will be considered for expansion with additional~     subjects enrolled. The cohort showing the highest response rate will be given highest~     consideration, as determined by the Sponsor-Investigator. Trial accrual is anticipated to~     occur over two years with 21 subjects enrolled during the first stage (7 in each cohort) with~     the opportunity for an additional 25 to be enrolled if a cohort is expanded. Subjects~     enrolled will follow the same procedure and treatment schedule, regardless of cohort~     assignment.~   "
72931|NCT02612350|"~     Pathway Genomics Corporation (Pathway Genomics), a San Diego, California company, is involved~     in the development and validation of new molecular diagnostic assays for the analysis of~     circulating tumor deoxyribonucleic acid (DNA) (ctDNA) found in the plasma-derived DNA~     (cell-free DNA or cfDNA) in order to identify specific variants (mutations) in cancer driver~     genes. The purpose of testing for mutations in ctDNA is to detect and monitor cancer. All~     cells shed DNA into the bloodstream. Finding cancer-associated mutations in the cfDNA may~     lead to early detection of cancer in an otherwise apparently healthy (i.e. asymptomatic)~     individual or may allow the healthcare provider to more effectively monitor and treat a known~     cancer patient. The analysis is performed using a polymerase chain reaction (PCR)-based~     methodology where oligonucleotides are designed to target specific mutations in designated~     genes of interest followed by next generation deep sequencing of the amplified targets.~     Evaluation of the performance of these assays for screening for cancer in asymptomatic~     subjects is essential for the clinical validation of the use of these assays. The specific~     aim of this protocol is to obtain relevant human blood samples from individual subjects at~     higher than average risk for the development of cancer due to age, heredity, or environmental~     or toxic exposures for use in the statistical analysis of this method as an adjunct screening~     test for the potential presence of cancer.~   "
72932|NCT02612337|"~     The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of~     Meniere's disease.~   "
72933|NCT02612324|"~     The purpose of this study is to determine the impact Pono Choices has among youth for teen~     pregnancy and STI prevention measures such as: initiation of sexual activity; engagement in~     high risk sexual behaviors; knowledge of pregnancy and STI prevention; attitudes toward~     healthy sexual behaviors; skills in managing relationships and choices; and intentions about~     future sexual activity.~   "
72934|NCT02612311|"~     This study evaluates the combination of ublituximab, a novel monoclonal antibody, and~     TGR-1202, a novel PI3K delta inhibitor compared to obinutuzumab and chlorambucil, and~     compared to ublituximab or TGR-1202 alone in Chronic Lymphocytic Leukemia (CLL) patients.~   "
72935|NCT02612298|"~     The purpose of this study is to compare the efficacy and safety of Arotinolol Hydrochloride~     and Metoprolol succinate on morning blood pressure, heart rate and target organ damage in~     patients with essential hypertension. To provide evidence for hypertension treatment.~      A group: Arotinolol Hydrochloride, oral, 5-15mg, bid for 12 weeks. B group: Metoprolol~     succinate sustained-release tablet, oral, 23.75-71.25mg, qd for 12 weeks.~   "
72936|NCT02612285|"~     SNX-5422 is a pro-drug of SNX-2112, a potent, highly selective, small-molecule inhibitor of~     the molecular chaperone heat shock protein 90 (Hsp90). Initial in vitro evidence supports~     that SNX-5422 may be active against TP53 null tumors irrespective of tumor type .~   "
72937|NCT02612272|"~     This study will compare the efficacy of intra-articular betamethasone injection to~     intra-articular ketorolac injection for symptomatic treatment of knee osteoarthritis in an~     equivalence study using a double-blinded, randomized, controlled design. Patients will be~     recruited from orthopaedic clinics at St. Luke's University Health Network. A total of 448~     patients will be recruited (224 in each group) to receive an administration of an~     intra-articular betamethasone or ketorolac injection. The primary outcome is change in pain~     as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)~     score. Secondary outcomes include Knee Injury and Osteoarthritis Outcome (KOOS) and Knee~     Outcome Survey - Activities of Daily Living (KOS-ADL) scores and physical exam findings.~     Statistical analyses include repeated measures analysis of variance (ANOVA) (primary outcome)~     and selected ANOVA and nonparametric tests as deemed appropriate (secondary outcomes), with p~     < .05 denoting significance for all comparisons, and no adjustment for multiple testing.~   "
72938|NCT02612259|"~     A phase II, randomized, double-blind, placebo-controlled, in parallel groups clinical trial~     to assess the safety and efficacy of dietary supplementation with tryptophan to achieve~     weight loss, and its neuropsychological effects in adolescents with obesity.~   "
72939|NCT02612246|"~     The purpose of this First-in-Human study is to evaluate the safety and tolerability after~     single ascending oral doses of GLPG1972 given to healthy subjects, compared to placebo. Also,~     the safety and tolerability of multiple ascending oral doses of GLPG1972 given to healthy~     subjects daily for 14 days compared to placebo, will be evaluated.~      Furthermore, during the course of the study after single and multiple oral dose~     administrations, the amount of GLPG1972 present in the blood and urine (pharmacokinetics)~     will be characterized.~      The effect of food on the pharmacokinetics of GLPG1972 will also be evaluated. The potential~     of cytochrome P450 (CYP)3A4 interaction after repeated dosing with GLPG1972 will be explored~     as well.~      During the course of the study after multiple oral dose administrations, the effect of~     GLPG1972 on biomarkers present in the blood (pharmacodynamics) will be characterized.~   "
72940|NCT02612233|"~     Osteoarthritis is the most common form of arthritis worldwide. Specifically, osteoarthritis~     of the hands affects millions of people and is a major cause of hand disability and pain.~     Despite this, there are currently no treatments that delay or halt the development of~     osteoarthritis. Pain is one of the major symptoms of osteoarthritis and pain management is an~     important factor to consider in the treatment of this condition. Treatments for pain in~     osteoarthritis consists of local injections, anti-inflammatory gels or painkillers such as~     paracetamol. However, most people with osteoarthritis still have pain despite these~     treatments.~   "
72941|NCT02612220|"~     The present randomized controlled trial evaluates the efficacy and safety of BioFoam®~     Surgical Matrix in patients undergoing elective liver resection. In contrast to other topical~     agents, the surgical adhesive BioFoam® Surgical Matrix may not only accelerate hemostasis but~     also facilitate sealing of bile ducts and thus has the potential to reduce the incidence of~     postoperative complications.~      The primary objective of this trial is to show that time-to-complete hemostasis can be~     reduced using BioFoam® Surgical Matrix as compared to the conventional approach.~   "
72942|NCT02612207|"~     The aims of this project are to validate the performance of the miniaturized and modernized~     hematofluorometer that measures bilirubin capacity into a product and is suitable for~     operation in various point of care environments when encountering confounding direct~     bilirubin, to complete the development of easy to use sample handling disposables, and to~     verify the performance of the system for samples from a specified population of neonates.~   "
72947|NCT02612142|"~     35 participants diagnosed with major depressive disorder were randomized in 3 intervention~     groups: (1) aerobic exercise (AE) ; (2) placebo (stretching) exercise (ST); and (3) no~     intervention (control group; NI). The intervention length was 10 consecutive days. In groups~     1 (aerobic exercise) and 2 (sham exercise), participants exercised for 30 minutes each day.~     Depressive symptoms were assessed the day before the beginning of intervention and the day~     after the end of intervention for participants of both groups.~   "
72948|NCT02612129|"~     A prospective, randomised, double-blind, placebo controlled therapeutic study in patients~     with confirmed diagnosis of NiemannPick disease type C (NPC).~      The purpose of this study is to assess the efficacy and safety of arimoclomol (compared to~     placebo) when it is administered as an add-on therapy to the patient's current prescribed~     best standard of care; patient's standard of care may, or may not, include miglustat.~   "
72949|NCT02612116|"~     The purpose of this study is to evaluate the differences in pharmacokinetics and~     pharmacodynamics of ticagrelor and its active metabolite depending on the strategy of the~     drug administration in patients with unstable angina pectoris.~   "
72950|NCT02612103|"~     Ulcerative colitis (UC) and Crohn's disease (CD) are chronic relapsing inflammatory bowel~     diseases (IBD). At the time of diagnosis it is not possible to predict the course of the~     disease, which can range from a few flares in a lifetime to uncontrollable disease leading to~     hospitalization, surgery and stoma. There is a continuous need to improve diagnostic and~     prognostic tools.~      In chronic inflammation diseases there is an excessive turnover of the extracellular tissue.~     Tissue is broken down to small fragments and released into the circulation. Changes in the~     amount of these fragments in the blood may provide information on the damage and quality of~     the affected tissue and may therefore act as objective measure of disease burden and severity~     - a so called biomarker.~      The potential of such biomarkers is evaluated in a combined cross-sectional and longitudinal~     survey including 300 patients with UC, CD, irritable bowel disease and healthy controls. The~     patients are followed for up to 1 year. Changes in biomarker are correlated to standard~     markers of inflammation during active disease and remission.~      Perspective The use of new biomarkers may offer a tool to evaluate early changes in the gut~     of patients with IBD, may be a supplement to the diagnosis, serve as markers for effect of~     treatment and prognosis, and in time be a good alternative to fecal samples or endoscopy.~   "
72951|NCT02612090|"~     Primary objective is to assess strawberry intake on LDL cholesterol and its association with~     atherosclerosis development.~   "
72952|NCT02612077|"~     This is a longitudinal, multicenter, prospective, pharmacoepidemiological study to evaluate~     progression free survival (PFS) in a real-life setting in participants with metastatic~     colorectal cancer (mCRC) starting chemotherapy combined with bevacizumab.~   "
72953|NCT02612064|"~     This single centre, dual site, comparative design study will be used to investigate the~     efficacy of an experimental stannous fluoride containing dentifrice in relieving dentinal~     hypersensitivity (DH) after short term use~   "
72954|NCT02612051|"~     GSK3008348 is an investigational drug, being developed by GlaxoSmithKline Research and~     Development Limited (the Sponsor, a pharmaceutical company based in the UK) for the treatment~     of Idiopathic Pulmonary Fibrosis (IPF). IPF is a rare and poorly understood disease that~     causes scarring of the lungs. The main symptoms are shortness of breath and a dry cough.~     Symptoms generally worsen over time and in some subjects may prove fatal. The cause of IPF is~     unknown.~      This is a First Time in Human, Phase 1, 3-part study which is being carried out on behalf of~     the Sponsor by Quintiles. The primary purpose of Part A is to examine the safety and~     tolerability of single nebulised (a medicated spray) doses of GSK3008348 following inhalation~     in healthy volunteers. The secondary objective is to determine how and at what rate the body~     absorbs, distributes, breaksdown and eliminates the drug.~      Parts B and C of this study will be in-patients with Idiopathic Pulmonary Fibrosis (IPF). The~     purpose of Part B and C is to examine the safety and tolerability, and how much of the drug~     binds to its target, following single nebulised (a medicated spray) doses of GSK3008348~     following inhalation in patients with Idiopathic Pulmonary Fibrosis (IPF). The secondary~     objective is to determine how and at what rate the bodies of these patients absorbs,~     distributes, breaksdown and eliminates the drug.~      The total duration of Part A will be 65 - 87 days, Part B 62 days and Part C 43 days.~   "
72955|NCT02612038|"~     Obstructive sleep apnea (OSA) is inherently site-specific. In a physiological controlled~     intervention study, the investigators seek to determine whether applying expiratory~     resistance can acutely improve ventilation and sleep in patients with expiratory flow~     limitation (EFL).~   "
72956|NCT02612025|"~     The purpose of this study is to determine whether combined endurance and resistance training~     can improve muscle strength in children and adolescents with cancer during the intensive~     treatment phase.~   "
72957|NCT02612012|"~     This study is designed to evaluate the feasibility and safety of axillary radiotherapy for~     early stage breast cancer with limited positive sentinel lymph nodes.~   "
72958|NCT02611999|"~     The investigators' study seeks to explore the impact of price information on physicians'~     ordering behavior and care quality. The investigators will evaluate the impact of the~     physician price transparency initiative at Atrius Health (ATRIUS) on rate of overall~     procedure and test orders, clinically inappropriate orders, and appropriate orders.~     Ultimately, this study will help stakeholders understand the degree to which price~     information can help improve the value of healthcare.~   "
72959|NCT02611986|"~     A randomized controlled prospective study of laryngoscopy and intubation success comparing~     direct laryngoscopy and the McGrath® Mac videolaryngoscope.~   "
72960|NCT02611973|"~     The hypothesis is that efficient prevention of thrombosis with aspirin at diagnosis becomes~     less useful once patients have achieved a hematologic response (HR) (modified by amendment~     1/03/2017) and/or that this benefit is hampered by an increased hemorrhagic risk especially~     in elderly patients.~      Hence, investigator propose a prospective randomized study to assess the benefit / risk ratio~     of aspirin maintenance in high risk Essential thrombocythemia (ET) patients, in hematological~     response (modified by amendment 1/03/2017) on Hydroxyurea.~   "
72981|NCT02611700|"~     This clinical study is designed as a phase 3,multicenter, double-blind, randomized,~     controlled study,to evaluate the efficacy and safety of nimotuzumab combined with~     paclitaxel+cisplatin（TP) compared with TP as first-line treatment for the metastatic~     esophageal squamous carcinoma.~   "
72961|NCT02611960|"~     This is a study of pembrolizumab (MK-3475) versus standard of care (SOC) treatment~     (capecitabine, gemcitabine, or docetaxel) for the treatment of recurrent or metastatic~     nasopharyngeal cancer (NPC). Participants will be randomly assigned to receive either~     pembrolizumab or Investigator's choice of standard treatment.~      The primary study hypothesis is that pembrolizumab treatment prolongs progression-free~     survival (PFS) and overall survival (OS) when compared to SOC treatment.~   "
72962|NCT02611947|"~     Various indexes have been proposed to quantify both pulmonary emphysema and airways disease~     on chest CT scans. It is unknown whether these indexes should be consider in absolute values~     or as compared to predicted normal values. The purposes of the present study is thus : a) to~     measure these indexes at CT in healthy volunteers; b) to investigate their relations with~     gender, height and weight.~   "
72963|NCT02611934|"~     Mild Therapeutic Hypothermia for Patients with Acute Coronary Syndrome and Cardiac Arrest~     Treated with Percutaneous Coronary Intervention (UNICORN) study is designed to determine~     whether mild therapeutic hypothermia (MTH) applied in patients with acute coronary syndromes~     (ACS) and cardiac arrest treated with percutaneous coronary intervention (PCI) is associated~     with better clinical outcomes as compared with therapy without MTH.~   "
72964|NCT02611921|"~     The purpose of the study is to determine if intranasal ketamine shows initial evidence of~     safety, tolerability and efficacy for the treatment of social impairment in individuals with~     Autism Spectrum Disorder.~   "
72965|NCT02611908|"~     The purpose of the study is to investigate whether the combination of obinutuzumab and~     ibrutinib (administered up to 840 mg per day) might be useful for the treatment of CLL or SLL~     that is not responding or no longer responding to treatment with ibrutinib alone. The study~     will evaluate whether this regimen can reduce the amount of cancerous cells in the body.~     Subjects will be treated with ibrutinib at a dose of up to 840 mg a day by mouth, as well as~     obinutuzumab infusions. Although both of these agents are approved by the FDA for the~     treatment of CLL or SLL, the combination and the dosing schedule of ibrutinib are considered~     experimental.~   "
72966|NCT02611895|"~     There is a theoretical possibility of a complete suppression of HIV viral replication,~     subject to the use of highly active associations of more than 25 antiretroviral drugs~     currently available and good treatment adherence. But a key question remains: whether it can~     persist viral replication low noise HAART, since several arguments suggest a subclinical~     escape of the virus to HAART at least in some individuals. The technique proposed in this~     research consists of the detection and quantification of the linear viral cDNA intra~     cytoplasmic, as persistent novo infection marker in order to highlight the subclinical~     replication active in treatment of HIV-1 and consider an optimized therapeutic management of~     patients.~      Main objective : Comparing the frequency of patients infected with HIV and treated~     effectively (HIV viral load undetectable plasma with conventional methods) having the HIV DNA~     into the cytoplasm of their CD4 + T cells from peripheral blood, as cellular infection marker~     novo persistent, among patients with a therapeutic regimen contains or not the viral~     integrase inhibitor raltegravir.~      Secondary objectives~        -  To evaluate the frequency of patients infected with HIV and treated effectively with the~          HIV DNA into the cytoplasm of their CD4 + T cells from peripheral blood~        -  Evaluate the causes of persistent infection in de novo virological responders to~          treatment with ART: presence of the HIV genome encoding strains resistant to treatment~          ART ongoing noncompliance to treatment, type of antiretroviral therapy, CD4 nadir ,~          pretreatment level of plasma HIV RNA, total duration of ART~        -  Assess the impact of persistent novo infection virological responders: cell activation~          CD4 + and CD8 +, lack of immunological treatment response, changes in lymphocyte ratio T~          naïve / memory cells cells, the presence of transient increase viremia, residual viremia~          levels~        -  Identify virological responders may benefit from treatment intensification~   "
72967|NCT02611882|"~     The investigators are imaging patients with prostate cancer using a new PET imaging agent~     (Ga-68 HBED-CC PSMA) in order to evaluate it's ability to detection prostate cancer in~     patients with high risk disease prior to prostatectomy, patients with biochemical recurrence~     and patients with castrate resistant prostate cancer.~   "
72968|NCT02611869|"~     120 consecutive patients with paroxysmal AF, slated for PV isolation, will be randomly~     assigned to RF or cryoballoon ablation (in a 1:2 allocation scheme). Real-time 3D~     echocardiography (RT3DE) will be performed before the ablation procedure and 1 month~     post-ablation. The RT3DE datasets will be stored digitally and quantitative analyses will be~     performed off-line at a core echo laboratory. Quantification of left atrial volumes will be~     performed and left atrial functional quantification will be performed by calculating the~     following indices: Left atrial ejection fraction, Active atrial emptying fraction, Passive~     atrial emptying fraction, Atrial expansion index. All patients will be hospitalized for 48~     hours post-ablation. Blood samples will be obtained at 12-hour intervals to measure troponin~     T with a high-sensitivity assay, as well as other biochemical parameters.~   "
72969|NCT02611856|"~     The twin pregnancies monochorionic are specifically explained to two main types of~     complications: the anomalies of the embryo affecting a symmetry and in particular the median~     line on one hand and malformative sequences of vascular origin on the other hand. This last~     category of anomalies (twin-to-twin syndrome, TTTS) develops because of the presence of a~     division of the foeto-placentary circulation between both twins through the pooling of~     certain placentary cotyledons. The latter are then vascularized by an arterial and venous~     foot belonging to both foetuses (anastomoses arteria-venous or veinous-arterial). It results~     from it an imbalance moderate but very early hemodynamic which is going to return a~     hypovolume twin (the donor) and its plethoric co-twin (the recipient).~      These anomalies in utero could not only have consequences during the fetal life, on the born~     weight and the later development of newborns, but also on the organization and the~     functioning of a whole series of physiological systems. So these anomalies of the pregnancy~     could have also consequences which exceed by very far from the perinatal period, by favoring~     the development of the atheroma, the high blood pressure, the resistance in the insulin, and~     many other metabolic and endocrine functions were known for their importance in human~     pathology.~      For these reasons the investigators suggest estimating the tensional, cardiac and metabolic~     status of children ex-transfusers and of children ex-transfused in 2 different age classes:~     between 4 and 8 years then when these children will have between 12 and 16 years.~      There are also some evaluation clinical and biological of the puberty (only at the age of~     12-16)~      To understand a possible effect of the prenatal status of these children on the endocrinology~     of the puberty, the measures and the following dosages will be realized:~        -  Test in the GnRH (T0, T30, T60, T90): dosages of LH and FSH (relationship of peaks to~          determine the puberty evolution),~        -  Dosages of the sexual steroids, the oestradiol for the girl and the testosterone for the~          boy,~        -  Clinical examination looking for the signs of puberty~      This if study leans on the big originality of the physiopathological model of TTTS in which~     the children present the peculiarity to have an identical genetic and postnatal status and a~     different prenatal environment.~      The follow-up of these children should allow:~        -  To understand better the postnatal impact anomalies on these children in the course of~          pregnancy~        -  To anticipate and thus to improve their care in case of appearance of biological or~          clinical signs~   "
72980|NCT02611713|"~     This study is a non-interventional post-marketing observational study (PMOS) of participants~     with advanced Parkinson's disease (PD) treated with Duodopa/Duopa in a routine clinical~     setting. Effectiveness of treatment will be collected with physician and~     participant/caregiver health outcomes beginning with PMOS enrollment (baseline visit), at the~     start of Duodopa/Duopa treatment via percutaneous endoscopic gastrostomy-with jejunal~     extension (PEG-J), at regularly scheduled visits closest to Months 3 and 6, and every 6~     months thereafter up to 36 months.~   "
72982|NCT02611687|"~     The purpose of this multicenter double blind study is to assess efficacy and safety of~     Pitolisant versus placebo in paediatric Narcoleptic patients with or without cataplexy.~   "
72970|NCT02611843|"~     Veterans who served in Iraq and Afghanistan have high rates of co-morbid PTSD symptoms and~     hazardous substance use (HSU). Evidence-based treatments for these problems are available in~     VA specialty clinics, but multiple barriers lead to low utilization of these treatments.~     Novel treatment approaches are needed. Previous research supports that 1) primary care-mental~     health integration (PC-MHI) services are associated with increased treatment engagement, 2)~     technology-based interventions are well accepted by Veterans and are more effective when~     delivered with professional support, and 3) Veteran peer services are associated with~     improved treatment engagement, patient motivation, and overall functioning. This study will~     add a Peer-Support component to an existing Web-based Cognitive Behavioral Treatment (CBT)~     for PTSD and HSU called Moving Forward. Preliminary data analyses from our NIAAA-funded trial~     indicate that participants who used Moving Forward more had larger reductions in PTSD~     symptoms. Qualitative feedback supports that Veterans want interpersonal interactions while~     receiving treatment and need help engaging in the treatment more fully. Therefore, this pilot~     study will investigate if adding peer support to Moving Forward improves patients outcomes. A~     randomized controlled trial (N=30) comparing Moving Forward to Peer-Supported Moving Forward~     will be conducted. The peer support component will consist of semi-structured brief sessions~     conducted weekly for the 12 weeks of study treatment by a VA-certified peer support~     specialist. Peers will receive study-specific training and weekly supervision from clinicians~     that are part of the study staff. Primary outcomes will include process outcomes (treatment~     engagement, patient satisfaction) and clinical outcomes (PTSD symptoms, alcohol and substance~     use, quality of life).~   "
72971|NCT02611830|"~     The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab~     SC) maintenance treatment in participants with moderately to severely active ulcerative~     colitis (UC) who achieved clinical response following administration of vedolizumab~     intravenous (vedolizumab IV) induction therapy.~   "
72972|NCT02611817|"~     The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab~     SC) as maintenance treatment in participants with moderately to severely active Crohn's~     disease (CD) who achieved clinical response following administration of vedolizumab~     intravenous (vedolizumab IV) induction therapy.~   "
72973|NCT02611804|"~     To compare the efficacy and safety profiles of Teva's Diclofenac Sodium Gel, 5% (test~     product) to Solaraze® (diclofenac sodium) Gel, 3% (reference product) to demonstrate the~     clinical equivalence and to show that the efficacy of the 2 active formulations is superior~     to that of vehicle in treating subjects with actinic keratosis (AK) on the face or bald~     scalp.~   "
72974|NCT02611791|"~     OBJECTIVES: The aim of the study is to evaluate the clinical response of the non-ablative~     radiofrequency (RF) in the outcome cosmetic female external genital and its effect in the~     sexual function. METHODS: Single blind randomized controlled trial. Sample of 43 women (29~     sexual active) with insatisfaction appearance of the external genitalia, 21 (14) in the study~     group and 22 (15) in the control group. The protocol consisted in 8 sessions of RF once a~     week. The instruments of evaluation were photo (taken before the first session and eight days~     after the last session), which were evaluated by the patient and by three health professional~     (that did not know the group); by the 3 points Likert scale (unsatisfied, unchanged,~     satisfied) and (worst, unchanged, improved). The sexual function was evaluated by the Female~     Sexual Function Index (FSFI) before and after, and analyzed by the T Test of Student. The~     patients' satisfaction and the health professionals' evaluation were analyzed by the~     chi-squared test and by binomial comparison inter-group and intra-group.~   "
72975|NCT02611778|"~     The purpose of this study is to determine the efficacy and safety of the biosimilar~     ranibizumab FYB201 in comparison to Lucentis in patients with neovascular age-related macular~     degeneration.~   "
72976|NCT02611765|"~     Syphilis remains a significant health problem worldwide, with an estimated 10.6 million new~     cases per year. Due to shared transmission route and risk factors, co-infection with syphilis~     and Human Immunodeficiency Virus (HIV) is not uncommon. Several studies have evaluated the~     response to syphilis treatment in HIV-infected patients. They support the claim that patients~     with HIV have a slower decrease in syphilis antibody titers, and that they may progress to~     neurosyphilis in earlier stages.~      The Center for Disease Control and Prevention's Sexually Transmitted Disease Treatment~     Guidelines has advocated treating HIV-infected patients who have primary, secondary syphilis~     or early latent syphilis with the same doses of penicillin as for HIV-uninfected patients~     (single dose of 2.4 million units of benzathine penicillin G). The investigators designed a~     randomized controlled trial in order to compare the efficacy of three- versus single-dosed~     regimens of intramuscular benzathine penicillin G (BPG) for the treatment of early syphilis~     in HIV-infected patients.~   "
72977|NCT02611752|"~     Multi-site, randomized, double-blind, repeat-dose Phase 2 study to evaluate the degree and~     duration of action of multiple doses of CAM2038 in blocking the effects of hydromorphone in~     patients with moderate or severe opioid use disorder.~   "
72978|NCT02611739|"~     Pain is a frequent and significant problem related to cancer-directed treatment in children.~     Children with cancer often cite needle procedures as the most distressing experience caused~     by cancer and its treatment. Recently it has been shown that an interactive humanoid robot is~     capable of facilitating distraction and reducing distress during childhood immunizations. Our~     research objectives are to: (1) assess the feasibility of implementing the robot (Medi-Port)~     for effectiveness testing in a future RCT (measured as implementation outcomes) and (2)~     determine treatment effectiveness estimates (measured as preliminary effectiveness outcomes),~     compared to standard medical care.~   "
72979|NCT02611726|"~     Rationale for conducting the experiment: Israel performed IVF treatments since 1980.~      Although ART (Advanced Reproductive Treatments) have evolved over the years implantation and~     pregnancy rates have not met the expectations yet. Success rates of fertility treatments are~     about 15-18% (clinical pregnancy rates =CPR). As a result additional methods (clinical,~     technological and complimentary) have been tried to improve the CPR.~      In some reviews the effects of acupuncture practice during fertility treatments showed~     certain benefits, including pain relief and relaxation. Unfortunately those trials were not~     randomized and lacked methodological rigor.~      The aim of this study is to evaluate the effect of acupuncture on pain, anxiety, and CPR of~     women undergoing IVF as compared to standard care alone.~   "
72983|NCT02611674|"~     The primary objectives of the study are to estimate and rank-order the longitudinal~     standardized mean changes over 6 months and over 12 months, for a set of novel outcome~     measures administered to participants with amyotrophic lateral sclerosis (ALS), in order to~     identify measures that are more sensitive to disease progression than Amyotrophic Lateral~     Sclerosis Functional Rating Scale-Revised (ALSFRS-R). The secondary objectives of this study~     are: To evaluate the test-retest reproducibility of each outcome measure; To determine~     correlations between 6 and 12-month changes in all exploratory measures with 18 and 24-month~     changes in ALSFRS-R and survival; To assess correlations between/among the various measures;~     To obtain biological samples in order to identify molecular correlates to the clinical~     measures and to further characterize previously identified and novel molecular biomarkers of~     disease progression for incorporation into future clinical studies.~   "
72984|NCT02611661|"~     The rationale for this design is initial utilization of a standard-of-care therapy for mCRC~     (radioembolization) with a dose-calculation algorithm that has been verified as predictive~     for treatment response. Prediction of treatment failure will enable the proposed subsequent~     locoregional therapies which were selected based on safety profiles and feasibility. While~     the goal of this study is assessing feasibility and safety of this approach, the end goal of~     improving overall patient outcomes by improved hepatic tumor control.~   "
72985|NCT02611648|"~     This study is investigating the most effective way to sterilize duodenoscopes (scopes) used~     at Beth Israel Deaconess Medical Center (BIDMC). Right now, BIDMC uses the standard method of~     high level disinfection to sterilize scopes. Because infections have been passed by scopes at~     other institutions in the U.S., the investigators are exploring whether or not adding two~     different sterilization processes will reduce this risk of contamination.~      Bacteria may be passed from a patient's intestines to the scope. Or, if the scope is~     contaminated, bacteria may be passed from the scope to the patient. In order to understand~     how bacteria are passed, the investigators will be taking samples of the patient's intestinal~     bacteria to compare to the bacteria, if any, found on the scope.~   "
72986|NCT02611635|"~     The main research question of this patient survey is to assess AF patients' preferences~     associated with different attributes which describe the different available anticoagulation~     treatment options (VKA or NOACs and, in case of NOACs, Apixaban, Dabigatran or Rivaroxaban).~      VKA (Waran®) will be compared to Rivaroxaban.~   "
72987|NCT02611622|"~     Patient satisfaction is an important metric currently used to rate quality of healthcare in~     hospitals. Maximizing patient satisfaction scores is therefore significantly beneficial to~     any hospital establishment. Recent studies have shown patient satisfaction depends on~     multiple factors, including patient involvement in treatment decision-making processes and~     patients' knowledge of treatment options. Internal review of departmental patient~     satisfaction survey scores revealed deficits in the aforementioned areas of patient~     satisfaction, with the domains of how well concerns were addressed, explanation of tests~     and procedures and effort to include patients in decisions having the lowest scores on~     patient satisfaction surveys. This highlights the gap in patient satisfaction that the~     Otolaryngology department seeks to improve on, so as to maximize patient satisfaction, and in~     turn, the quality of healthcare provided.~      The aim of this study is to assess the improvement in patient satisfaction scores that can be~     obtained by incorporating LUMA ENT™, a disease-specific multimedia patient education~     software, into the treatment decisions for thyroid disorders. LUMA ENT™ is a leading patient~     education software that provides visual anatomic animations of disease processes, disease~     progression and treatment options to improve patients' knowledge. Thyroid disorders have been~     chosen for study due to their high frequency of occurrence in the patient population and~     generalizability to a wide medical audience.~      The investigators will perform a single-blinded randomized-controlled study of patients~     visiting the physician practices of the Department of Otolaryngology for management of~     thyroid disorders. Participants will be randomized into control and intervention groups. Upon~     completion of the routine physician-patient clinical encounter, the intervention group will~     view a 5- minute LUMA ENT™ video discussing their specific thyroid condition, its natural~     progression history, and treatment options. They will have an opportunity to ask the~     physician any further questions that arise from viewing the video. The control group will not~     view the LUMA ENT video. Patient satisfaction surveys will then be provided to both groups at~     the end of the visit as is routinely done and scores subsequently compared.~   "
72988|NCT02611609|"~     A study to examine the safety (and potential efficacy) of the adult stem cell investigational~     product, MultiStem, in adults who have Acute Respiratory Distress Syndrome (ARDS). The~     primary hypothesis is that MultiStem will be safe in ARDS patients.~   "
72989|NCT02611596|"~     The purpose of this investigation is to compare subjects at high risk for silent myocardial~     ischemia in the placebo group to subjects at high risk for silent myocardial ischemia in the~     ranolazine group to determine if ranolazine can be used as a treatment to decrease silent~     myocardial ischemia (SMI). Subjects at high risk for silent myocardial ischemia are defined~     in this protocol as diabetics with stable ischemic heart disease. This study will look at the~     impact ranolazine treatment has on biomarkers that have been shown to be highly associated~     with increased risk of morbidity and mortality in relation to SMI. If the hypothesis is~     correct, further studies can be conducted to determine if treatment with ranolazine has~     impact on long-term outcomes such as hospitalizations, myocardial infarction, congestive~     heart failure or sudden cardiac death.~   "
72990|NCT02611583|"~     Patients presenting to the ED with a chief complaint of acute low back pain and whom the~     providing physician feels symptomatic treatment is appropriate in the ED will be screened for~     inclusion in the study. The purpose of the study is to compare Transcutaneous Electrical~     Nerve Stimulation (TENS) as an adjunct to ibuprofen in the treatment of acute low back pain~     in the emergency department. Therefore, the aim of this prospective, randomized, double blind~     study is to evaluate the efficacy of ED administered TENS in acute low back pain patients~     during their ED visit.~   "
72991|NCT02611570|"~     This study utilizes the low dose computed tomography(LDCT) to detect the occurrence of early~     lung cancer among non-smokers in Taiwan. Subjects who have family history of lung cancer or~     have high risk exposures to lung cancer will be recruited to participate LDCT screening and~     followed up for their possible occurrence of lung cancer.~   "
72992|NCT02611557|"~     This study will apply novel, noninvasive structural and functional magnetic resonance imaging~     (MRI) methods to patients with mild and moderate breast cancer-related lymphedema (BCRL) for~     the first time to test fundamental hypotheses about relationships between lymphatic~     compromise and imaging biomarkers that may portend disease progression and individualized~     therapy response.~   "
72993|NCT02611544|"~     Fear of cancer recurrence (FCR) is one of the most prevalent, persistent, and disruptive~     sources of distress for adult cancer survivors. Prevalence rates for FCR have been estimated~     at up to 89%, with approximately half of cancer survivors reporting clinically significant~     levels of FCR. Despite the recognized prevalence, persistence, and suffering associated with~     FCR, effective and accessible treatments for FCR are lacking and urgently needed. Our~     long-term goal is to develop, evaluate, and implement effective behavioral interventions for~     cancer survivors suffering with FCR.~   "
72997|NCT02611492|"~     The Primary objective is to assess the non-inferiority of the experimental arm (arm B)~     compared to the control arm (arm A) in terms of Major Molecular Response (MMolR) after the~     4th cycle (MRD4) in patients aged 18-59 years old with de novo Philadelphia positive (Ph+)~     acute lymphoblastic leukemia (ALL)~   "
72998|NCT02611479|"~     To identify patient characteristics associated with non-response after spine fusion surgery~     for the treatment of degenerative disc disease (DDD).~   "
72999|NCT02611466|"~     The purpose of the study is to evaluate the analgesic efficacy of ASP7962 relative to~     placebo.~      This study will also evaluate the efficacy of ASP7962 relative to placebo on pain on walking,~     function and stiffness; the time course of efficacy of ASP7962 relative to placebo; the~     improvement in overall patient status of ASP7962 relative to placebo as well as the safety~     and tolerability of ASP7962 relative to placebo.~   "
73000|NCT02611453|"~     Carbon dioxide (CO2) gas is widely used for luminal insufflation during endoscopic retrograde~     cholangiopancreatography (ERCP) of the biliary tract. While frequently observed during~     routine ERCP, there are few data on the topic of air or CO2 cholangiography. Our primary~     aim is to compare radiographic cholangiograms in patients with biliary tract disease (from~     stones or strictures) during ERCP obtained by using carbon dioxide as the contrast medium vs.~     conventional iodinated contrast.~   "
73001|NCT02611440|"~     Medication adherence is a major factor to prevent vascular recurrence after a first ischemic~     stroke. Nevertheless, it is suboptimal and the implementation of specific interventions are~     needed to improve it.~      A patient - centered and pluriprofessional structured intervention, targeting the medication,~     introduced at hospital discharge and continued at home (by regular telephone contact) could~     improve medication adherence one year after stroke.~      This intervention would consist of semi structured interviews patient-pharmacist at different~     times during one year after stroke. The information about the therapeutic management of the~     patient will be shared between healthcare professionals : general practitioners (GP) and~     community pharmacists (CP), hospital clinical pharmacist (HCP) and physician (HPhys).~      It will allow for decrease of the recurrent stroke and others cardiovascular complications~     based on a better adherence to preventive medication. Furthermore the decrease of the~     iatrogenic events and the improvement of the quality of life of patients may be also~     associated.~   "
73002|NCT02611427|"~     After recuperating from low back surgery patients often perpetuate a sedentary lifestyle~     because they are concerned about injury and recurrent pain. The objective of this study is to~     test the feasibility of a program to increase lifestyle walking starting several months after~     low back surgery.~   "
73003|NCT02611414|"~     Functional dyspepsia is a very common disorder of great challenge to clinical management. A~     therapeutic targets is up-regulation of visceral pain threshold. The transcranial direct~     current stimulation (tDCS) is a novel therapy that pursues these properties, besides its~     safety and easy adherence. There is a great need of new treatments for functional dyspepsia.~     There is no current study evaluating tDCS for this disease.~   "
73004|NCT02611401|"~     Multiple Sclerosis has a great impact on psychological functioning of patients and can be~     associated with various psychological disorders and symptoms. The most prevalent one is~     depression, which ranges from 15% to 47%. Mindfulness Based Intervention (MBI) is a~     relatively brief and cost-effective program that has been studied in patients with several~     diseases.~      Aims. To evaluate the efficacy of a group-based MBI on depressive symptoms, QoL and on~     correlated symptoms of MS patients and their caregivers.~      Methods. The study design is a randomized controlled clinical trial. The subjects of the~     study are 88 patients with MS and depressive symptoms that will be pre-screened from among a~     catchment group of about 500 patients using the Beck Depression Inventory-II (BDI). The 88~     patients will subsequently be randomized into two groups (44 in the experimental group and 44~     in the active control group). The psychological assessment, independent and blind to~     treatment, will be performed with the same timing and tools: at baseline (T0), after~     treatment (T1), and 6 months after the end of the group intervention (T2). The assessment~     will encompass the administration of the clinical interview and other self-report~     questionnaires.~      The experimental group will undergo a 8 weekly sessions of 3 hours each (plus an all day~     session) with group based MBI. The MBI is an Mindfulness Based Stress Reduction protocol~     integrated with body centered techniques from Sensorimotor Psychotherapy, in order to better~     tailor it on the needs of people with MS suffering from depressive symptoms. The active~     control group is designed to control for the non-specific elements of the MBI treatment and~     will follow the same structure as the MBI. It will be based on a psycho-educational framework~     and will include relaxation techniques.~      Primary outcome measures in patients will be: 1) the proportion of participants at T1 and T2~     that does not have a BDI-II score greater than 13; 2) the proportion of patients no longer~     meeting the diagnostic criteria for mood disorders as assesses by the SCID; 3) the~     improvement of FAMS scores for the six primary aspects of QoL.~   "
73005|NCT02611388|"~     The purpose of this study is to explore the neurohumoral mechanism of deferent frequency TEAS~     pretreatment.~   "
73006|NCT02611375|"~     Non-invasive brain stimulation has gained increasing popularity and research support over the~     past several years. Recent research indicates that it might have benefits for improving hand~     function in people with spinal cord injury. The purpose of this study is to evaluate the~     effects of a type of non-invasive brain stimulation, known as tDCS, on hand function.~   "
73007|NCT02611362|"~     This study will develop and test a novel, smartphone based gaming intervention to improve~     adherence to medication to prevent HIV (known as Pre-exposure Prophylaxis, PrEP) and to~     decrease HIV risk behaviors among men who have sex with men (MSM). In the intervention,~     participants will engage with an immersive app/game on their iPhone that is connected to~     smart, electronic pill organizer/dispenser. Data on adherence from the pill dispenser will be~     integrated into the app/game wirelessly and will translate into enhancements during game~     play. While gaming, participants will gain information about their health, improve motivation~     for PrEP and medical appointment adherence, and practice healthy behaviors. If the~     intervention is found to be effective, it can be tested in a larger study and then~     disseminated to other people taking PrEP.~   "
73029|NCT02611063|"~     The purpose of this study is to evaluate whether fostamatinib, a drug that blocks activated B~     cells will be effective in preventing and treating chronic graft vs host disease (cGVHD)~     after allogeneic stem cell transplant. Activated B cells may play a role in development of~     cGVHD. Inhibiting the B cell activation using fostamatinib after allogeneic stem cell~     transplant may prevent the development of cGVHD.~   "
73030|NCT02611050|"~     This study is a multi-center randomized trial to evaluate the Multi-vessel Coronary Artery~     Disease Option Grid patient decision aid compared to usual care in patient reported~     decisional conflict, knowledge, and shared decision making.~   "
73031|NCT02611037|"~     The purpose of this study is to determine whether the transarterial chemoperfusion treatment~     with cisplatin, methotrexate and gemcitabine is safe and effective in adults with malignant~     pleural mesothelioma (MPM).~   "
73008|NCT02611336|"~     Pathophysiology of acromegaly cardiomyopathy is yet unclear and a specific treatment have not~     been indicated. It was already demonstrated the positive impact of phosphodiesterase type 5A~     (PDE5A) inhibition in several models of cardiomyopathy and in a model of endocrine~     cardiomyopathy due to type 2 diabetes mellitus. In this patients with diabetic cardiomyopathy~     it was demonstrated an improvement in cardiac kinetic, geometry and performance parameters~     and reduction of the ambulatory measurement of waist circumference.~      This represents the first study that evaluate heart remodeling and performance changes and~     metabolic/immunological/molecular parameters after 5-months of Tadalafil 20 mg in Acromegaly~     cardiomyopathy.~      The proposed research will test whether phosphodiesterase 5A inhibition could become a new~     target for antiremodeling drugs and to discover molecular pathways affected by this class of~     drugs and a network of circulating markers (miRNA) for the early diagnosis of acromegaly~     cardiomyopathy.~      We hypothesize that:~        -  the signal molecules cGMP and cAMP could underlie the hypertrophic/profibrotic triggers~          related to this model of endocrine cardiomyopathy and that chronic inhibition of PDE5,~          activating cGMP signaling pathways, could improve cardiac remodeling due to acromegaly~        -  PDE5 inhibition could have a role in lipolytic regulation;~        -  neuroendocrine (e.g. natriuretic peptides) and metabolic markers and chemokines (e.g.~          MCP-1, TGF-ß) might relate with left ventricular (LV) remodeling in Acromegaly;~        -  there are neuroendocrine (e.g. natriuretic peptides), metabolic markers and chemokines~          (e.g. MCP-1, TGF-ß) related to cardiac disease in Acromegaly;~        -  miRNA expression [miR-208a, 499, 1, 133, 126, 29, 233, 222, 4454] might relate with LV~          remodeling in Acromegaly.~   "
73009|NCT02611323|"~     This study will evaluate the safety, efficacy, and pharmacokinetics of induction treatment~     with obinutuzumab, polatuzumab vedotin, and venetoclax in participants with relapsed or~     refractory FL, and with rituximab, polatuzumab vedotin, and venetoclax in participants with~     DLBCL. Participants with FL who achieve complete response (CR), partial response (PR), or~     stable disease (SD) at the end of induction therapy will receive post-induction treatment~     with obinutuzumab and venetoclax, and participants with DLBCL who achieve CR or PR at the end~     of induction (EOI) will receive post-induction treatment with rituximab and venetoclax.~   "
73010|NCT02611310|"~     This is a prospective, national, multicenter, non-interventional study designed to enroll~     participants who have an initial diagnosis of unresectable LA/mBC made up to 6 months prior~     to registry enrollment. These participants will be prospectively followed for at least 5~     years after study enrollment to evaluate their anti-cancer treatments. Data on participants'~     previous anti-cancer treatments for breast cancer will be collected retrospectively at study~     entry.~   "
73011|NCT02611297|"~     The purpose of this study is to evaluate the the diagnostic yield and safety of~     transbronchial lung biopsies (TBLB) with cryoprobe in patients with mechanical ventilation.~   "
73012|NCT02611284|"~     The aim of this study is to assess the efficacy and feasibility of a new less invasive~     surfactant administration (LISA) technique with a specific designed cannula for surfactant~     administration using Beractant replacement in preterm infants <32 weeks of gestation and~     compare short and long term outcomes with the intubation, administration of surfactant and~     extubation method (INSURE).~      This was a single-center, prospective, open-label, non-randomized, controlled study with an~     experimental cohort of 30 patients treated with LISA and a retrospective control group~     comprising the 30 most recently treated patients with INSURE. Beractant (4 ml/Kg) was~     administered as exogenous surfactant in both groups if patients on nasal continuous positive~     airway pressure (nCPAP) during the first three days of life were needed of more than 30% of~     fraction of inspired oxygen inspired oxygen fraction (FiO2).~   "
73013|NCT02611271|"~     Cytokine adsorption using the cytosorb adsorber is currently investigated to reduce the~     levels of proinflammatory cytokines in patients with severe sepsis and septic shock. The~     adsorber is frequently used in series with continuous renal replacement therapy. Up to date,~     no data on the removal of antibiotic drugs during combined renal replacement therapy and~     cytokine adsorptive therapy is available. Therefore, we want to investigate~      - whether and to what extent antibiotic drugs (piperacillin/tazobactam and~     imipenem/cilastatin) are removed during combined continuous renal replacement therapy and~     cytosorb adsorption in patients with severe sepsis and septic shock~   "
73014|NCT02611258|"~     Pathophysiology of Cushing's Syndrome (CS) cardiomyopathy is yet unclear and a specific~     treatment have not been indicated. It was already demonstrated the positive impact of~     phosphodiesterase type 5A (PDE5A) inhibition in several models of cardiomyopathy and in a~     model of endocrine cardiomyopathy due to type 2 diabetes mellitus. In this patients with~     diabetic cardiomyopathy it was demonstrated an improvement in cardiac kinetic, geometry and~     performance parameters and reduction of the ambulatory measurement of waist circumference.~      This represents the first study that evaluate heart remodeling and performance changes and~     metabolic/immunological/molecular parameters after 5-months of Tadalafil 20 mg in Cushing's~     Syndrome cardiomyopathy. The proposed research will test whether phosphodiesterase 5A~     inhibition could become a new target for anti-remodeling drugs and to discover molecular~     pathways affected by this class of drugs and a network of circulating markers (miRNA) for the~     early diagnosis of Cushing's Syndrome cardiomyopathy.~      The investigators hypothesize that:~        -  the signal molecules cGMP and cAMP could underlie the hypertrophic/profibrotic triggers~          related to this model of endocrine cardiomyopathy and that chronic inhibition of PDE5,~          activating cGMP signaling pathways, could improve cardiac remodeling due to CS;~        -  PDE5 inhibition could have a role in lipolytic regulation;~        -  neuroendocrine (e.g. natriuretic peptides) and metabolic markers and chemokines (e.g.~          MCP-1, TGF-ß) might relate with left ventricular remodeling in CS;~        -  there are neuroendocrine (e.g. natriuretic peptides), metabolic markers and chemokines~          (e.g. MCP-1, TGF-ß) related to cardiac disease in CS;~        -  miRNA expression [miR-208a, 499, 1, 133, 126, 29, 233, 222, 4454] might relate with left~          ventricular remodeling in CS;~   "
73015|NCT02611245|"~     This study aims to first apply near-infrared fluorescence imaging technology in thoracic~     surgery with indocyanine green in China. To evaluate the feasibility usage of the~     investigators' fluorescence imaging systems and the safety applications in intraoperative~     sentinel lymph node mapping of lung and esophageal cancer, lung nodule imaging, lung segment~     resection boundary determination, esophagus - tubular anastomosis, thoracic duct imaging and~     chylothorax repairing thoracic surgery. Aim to achieve precise boundaries definition during~     thoracic surgery and realize accurate, minimally invasive thoracic surgery with fluorescence~     imaging technology.~   "
73016|NCT02611232|"~     The main objectives of the trial are to study whether daily treatment with liraglutide~     improves insulin secretion and glucose metabolism, and whether liraglutide treatment is~     tolerable and safe in subjects with preclinical type 1 diabetes aged 18-30 years.~   "
73017|NCT02611219|"~     The purpose of this feasibility study is to test the potential for successful implementation~     of an intervention designed to study the effect of six hours out of bed time on the overall~     level of deconditioning in pediatric stem cell transplant (SCT) patients. Previous research~     has demonstrated that deconditioning occurs rapidly over the course of the hospitalization~     post-transplant and can negatively impact quality of life. By encouraging patients to be out~     of bed for six hours each day, it is anticipated that patients will experience less~     deconditioning than those patients who previously had no established minimum time out of the~     bed.~   "
73032|NCT02611024|"~     Prospective, open-label, dose-ranging, uncontrolled phase I study with PM01183 in combination~     with irinotecan to determine the maximum tolerated dose (MTD) and the recommended dose (RD)~     of PM01183 in combination with irinotecan in patients with selected advanced solid tumors.~   "
73018|NCT02611206|"~     This study will be an open-label 6-week (30 session) trial of active repetitive transcranial~     magnetic stimulation (rTMS) using a fixed frequency (10 Hz) but varying stimulation~     intensities using a 3+3 study design for safety and tolerability amongst adolescents. This~     means that we will only enroll 3 participants at a time and give them rTMS at the stimulation~     intensity energy of 80% of motor threshold (MT). If all three participants complete the 6~     weeks of treatment with no major safety events (i.e. seizure), we will increase the energy~     for the next 3 participants by 5%. If 1 of the 3 participants has a major safety event, we~     will enroll 3 more patients at the SAME energy. We will proceed in this manner, increasing by~     5% after 3 subjects safely complete treatment at that energy, to a maximum energy of 120% of~     motor threshold. If 2 participants in each intensity level cohort experience a major safety~     event, we will discontinue running subjects at that energy level. If this happens at our~     initial energy level of 80% of MT, we will stop the study. If we reach 2 events in any of the~     higher energy cohorts, we will return to the previous energy level and complete the remainder~     of the subjects at that energy level.~   "
73019|NCT02611193|"~     Hypothesis: Manipulative treatment can relieve patients of discomfort and dysfunction and~     then be utilized as a cheap conservative management of CTS. Study design: Two-groups~     randomized single-blind interventional study.~   "
73020|NCT02611180|"~     Dendritic cells (DCs) serve as sentries for the immune system. DCs recognize foreign~     compounds (antigens) in the body, which they internalize and process. When DCs uptake foreign~     antigens, they migrate to secondary lymphoid organs, where the processed antigens are~     presented to T cells.~      Various DC subsets with unique cell lineages, surface protein markers, and tissue~     localization determinants have been identified. For example, Langerhans cells (LCs) and~     interstitial dendritic cells (intDCs) are DCs found in stratified epithelia, such as the~     skin. Though both are expressed in the skin, they differ with respect to their origin and~     surface protein content and can activate distinct types of immune responses. They may also~     have different specificities for the capture of antigens and presentation to circulating T~     cells.~      To date, it is unknown what role, if any, the different DC populations that reside or~     repopulate in the skin play in the development and progression of skin graft-versus-host~     disease (GVHD) following bone marrow transplant.~   "
73021|NCT02611167|"~     The purpose of this study is to assess the safety, feasibility, and efficacy of intravenous~     allogeneic bone marrow-derived mesenchymal stem cell (MSC) therapy for idiopathic Parkinson's~     disease (iPD).~   "
73022|NCT02611154|"~     Hypothesis: Intranasal administration of exogenous testosterone results in a characteristic~     profile during anti-doping testing, which is different than the profile seen when~     testosterone is administered into muscle, on skin or under the tongue.~      Objective: The investigators aim to characterize the unique steroid doping profile following~     administration of intranasal testosterone to healthy, active volunteer subjects.~   "
73023|NCT02611141|"~     Retromolar Intubation is a successful option for intubation in patients with an existing~     retromolar gap in the case that the conventional method fails.~      Therefore the investigators want to test if the retromolar gap is essential for performing~     the retromolar intubation technique.~   "
73024|NCT02611128|"~     Polycystic ovary syndrome (PCOS) is a common disorder marked by hyperandrogenism,~     oligo-/anovulation, and subfertility. The precise causes of PCOS are unclear, but the~     pathophysiology involves complex genetic and environmental influences. Importantly, not all~     girls with obesity have HA, and free testosterone (T) concentrations are highly variable in~     this group. Luteinizing hormone (LH) and insulin concentrations are significant but only~     partial predictors of free T in girls with obesity; significant unexplained variability in~     free T suggests that additional factors contribute to HA in this population. Abnormalities of~     ovarian and adrenal steroidogenesis are likely contributors in this regard, but such~     abnormalities are difficult to quantify. Recent Genome Wide Association Studies have~     identified DENND1A as a PCOS susceptibility gene candidate. Preliminary in vitro data~     strongly implicate a DENND1A splice variant called DENND1A Variant 2 (DENND1A.V2) as a~     contributor to excessive theca cell androgen production in PCOS. The investigators' primary~     goal with the proposed pilot study is to determine the relationship between urinary exosomal~     DENND1A.V2 mRNA and free T concentrations in peripubertal girls. The investigators~     hypothesize that urinary exosomal DENND1A.V2 mRNA quantity is a significant and independent~     predictor of peripubertal hyperandrogenemia. In this study, the investigators will carefully~     phenotype peripubertal girls with and without hyperandrogenemia (primarily in the form of~     hormonal, maturational, and anthropometric measurements) in addition to measuring urinary~     exosomal DENND1A.V2 mRNA. As a primary analysis, the investigators will examine the~     relationship between morning free testosterone and urinary exosomal DENND1A.V2, controlling~     for previously-described partial predictors of free testosterone (LH, insulin) in addition to~     potential confounders (BMI z-score, bone age). These studies will provide important~     information regarding the etiology of HA in peripubertal girls. Ultimately, these data may~     lead to a non-invasive test of ovarian/adrenal steroidogenic activity and support the~     development of a diagnostic test for PCOS in high-risk peripubertal girls (e.g., those with~     obesity).~   "
73025|NCT02611115|"~     Computed tomographic pulmonary angiography (CTPA) is considered the gold standard for the~     diagnosis of pulmonary embolism (PE). PE is a potentially fatal disease in which a thrombus~     is lodged into a pulmonary artery blocking blood flow and potentially leading to respiratory~     distress, acute right cardiac failure or death. Therefore early and correct diagnosis is~     crucial.~      The diagnostic and clinical value of CTPA has already been firmly substantiated.~     Unfortunately up to 7.3% of PE scans are still deemed to be non-diagnostic, for example due~     to insufficient contrast enhancement in the target arteries.~      Therefore future research should focus on two important aspects of CT imaging. On the one~     hand optimal enhancement for the individual patient, on the other hand preventing additional~     risk of CT imaging - namely contrast induced nephropathy (CIN) and radiation risk. Thus the~     purpose of our study will be to optimize radiation dose settings (e.g. tube voltage, tube~     current) and CM application for the individual patient in CTPA.~   "
73026|NCT02611102|"~     Determine the effects on lipoprotein profiles of high dose concentrated dietary SFA~     (saturated fatty acids) (from MCT (medium-chain triglyceride) oil + butter) in combination~     added to coffee. The study will be conducted as a RCT in healthy adults without~     cardiometabolic disease or conditions that influence lipoprotein metabolism or other specific~     dietary recommendations.~   "
73027|NCT02611089|"~     The objective of this work is to understand how the disruption of the muscle connective~     tissue contributes to the limb soft-tissue defects in radial dysplasia. In parallel, the~     researchers will investigate the role of muscle connective tissue in normal limb development.~   "
73028|NCT02611076|"~     The purpose of this study is to develop and test a series of culturally relevant and~     appropriate booklets in Spanish, designed to assist Hispanic smokers in quitting smoking and~     remaining smoke-free.~   "
73033|NCT02611011|"~     To determine if women can understand the instructions, carry out the test, and interpret the~     test results. Women will be recruited to complete a test instruction and comprehension~     assessment and a usability assessment.~   "
73034|NCT02610985|"~     Background:~      No randomised trials have been conducted, and only a single retrospective study exists~     comparing 3D and 2D laparoscopic hysterectomy. In that study, operative time for hysterectomy~     was significantly lower for 3D compared to 2D conventional laparoscopy. Complication rates~     were similar for the two groups. Thus, although one out of nine women is hysterectomized and~     although laparoscopy is one of the recommended routes of surgery, evidence whether to choose~     2D laparoscopy, 3D laparoscopy is sparse.~      Objective:~      To compare pain and recurrence to usual activity level. Secondary to compare complications~     during the operation, postoperative complications, time to return to work, length of hospital~     stay and operative time.~      Design:~      Investigator-initiated, blinded, randomised controlled trial.~      Intervention description:~      Operative procedures follow the same principles and the same standard whether the surgeon's~     vision is 2D or 3D.~      Trial size Roskilde/Herlev Hospital, Denmark:~      200 patients in each arm of the study.~   "
73035|NCT02610972|"~     A case-control study will evaluate the clinical utility of the Congo Red test GV-005 in~     following women with a clinical diagnosis of preeclampsia and clinically healthy women in the~     postpartum period~   "
73036|NCT02610959|"~     The overall aim of the present project is to investigate if intake of cod in pregnancy has~     impact on infant development up to 12 month. 142 pregnant women will be allocated into two~     groups, one counsuming cod two times the week for four months and one group will continue to~     follow their habitual diet. To study this, urine samples, dietary data and blood samples from~     the mother and from the infant, as well as data on neurodevelopment and cognitive functioning~     will be collected at several time points.~   "
73037|NCT02610946|"~     The purpose of this study is to empower adolescent renal transplant recipients to fully~     understand their medical condition as well as to help them acquire the skills to maintain a~     healthy allograft well into adulthood. It is hoped that introducing technological~     applications (apps) will assist adolescents in managing medications, clinic appointments, lab~     appointments, and in tracking fluid intake, blood pressure, caloric intake, and exercise~     frequency. The investigators aim to improve adolescent post-renal transplant outcomes~     (increase medication adherence, lower clinic and laboratory no-show rate, lower blood~     pressure and BMI, maintain creatinine clearance, decrease proteinuria, decrease incidence of~     allograft rejection, decrease hospitalizations) as well as reduce cost.~   "
73038|NCT02610933|"~     This study examines patients on chronic hemodialysis with non-valvular atrial fibrillation,~     who have a CHA2DS2-VASc Score of ≥ 2 and therefore are candidates for or already receive a~     vitamin K antagonist.~      The first question is whether replacement of the vitamin K antagonist by rivaroxaban is able~     to slow progression of vascular calcification. The second question is whether addition of~     vitamin K2 to rivaroxaban can further slow down or even halt the progression of vascular~     calcification.~   "
73039|NCT02610920|"~     This study evaluates a new method of testing the lymph nodes in the armpit of patients with~     breast cancer for tumor involvement. All participants involved in this study will undergo an~     injection of a small amount of iron dissolved in liquid followed by an ultrasound of the~     axilla that will make previously invisible lymph nodes visible, allowing them to be sampled~     in an outpatient setting.~   "
73040|NCT02610907|"~     The study investigates the impact real output (subjects own) and simulated output have on the~     adhesion of adhesives.~   "
73041|NCT02610894|"~     The purposes of this study are to determine if use of the Postoperative Care at Home (PoCAH)~     tailored self-management program delivered via mobile technology (a mobile app) after~     discharge to home will result in: 1) fewer and/or less intense patient symptoms (pain, nausea~     and vomiting, fatigue, sore throat, constipation, sleep dysfunction); 2) enhanced patient~     satisfaction, perceived self-efficacy, and quality of life; 3) lower healthcare resource use~     (patient to healthcare provider calls; unscheduled patient appointments with healthcare~     providers; and hospital readmission and emergency department use). A secondary objective is~     to assess how easy the mobile app was to use after orthopaedic ambulatory surgery.~   "
73042|NCT02610881|"~     This study seeks to assess the acceptability, compliance, and preference for iron~     supplementation; micronutrient powders (MNP) versus iron syrup. Additionally, this study~     seeks to assess front line health worker perceptions and experiences regarding ease of~     implementation of each strategy and delivery strategy preference.~   "
73043|NCT02610868|"~     Multicenter, open-label, outpatient study of the safety and effectiveness of repeated doses~     of MYOBLOC over a 1-year duration in adult subjects with troublesome sialorrhea.~   "
73044|NCT02610855|"~     This study will explore the relationship between skeletal muscle and physical activity in~     scoliosis patients to provide insight into both the etiology of scoliosis and potential ways~     to mitigate the potential harms of treatment.~   "
73045|NCT02610842|"~     Hands are commonly affected in Systemic Sclerosis (SS). The objective of this research is to~     apply a home based hand care guide in patients with SS and to evaluate its response regarding~     hand pain, function, strength and mobility.~   "
73046|NCT02610829|"~     To evaluate serum levels of gamma tocopherol and it's metabolites after 3 doses, each~     separated by 12 hours.~   "
73047|NCT02610816|"~     The purpose of this interventional study is to test and compare the effectiveness of two~     elimination diets—the 1-food elimination diet (1FED, milk only) and the 4-food elimination~     diet (4FED, milk, egg, wheat, and soy). The study will also test the effectiveness of~     swallowed glucocorticoid therapy in some of the study participants for whom diet therapy was~     not effective.~   "
73048|NCT02610803|"~     The purpose of this study is to estimate the clinical relevance of monitoring patients with~     acute ischemic stroke with 48 hours' inpatient cardiac telemetry in relation to evaluate the~     presence of brief runs of premature atrial complexes and new diagnosed atrial fibrillation.~     Furthermore to evaluate the prognostic significance of brief runs of premature atrial~     complexes in relation to develop atrial fibrillation, recurrent stroke/transient ischemic~     attack and death.~   "
73058|NCT02610673|"~     This is an observational, prospective, non-randomized collection of defined clinical data~     under normal conditions of use for the WiCS-LV System, an implantable cardiac pacing system~     capable of delivering pacing energy to the left ventricle of the heart without using a pacing~     lead.~      Patients will be enrolled and followed according to standard of care for 5 years.~   "
73049|NCT02610790|"~     The aim of this study is to quantify pre- and postoperative physical activity of patients~     operated on colorectal surgery. Daily physical activity (No. of footsteps) is going to be~     recorded from 15 days before surgery to the end of hospitalization after surgery in a~     prospective cohort of consecutive colorectal patients by use of an attached strap. Then, the~     investigators will propose physical activity thresholds (adapted to the age, gender and~     patient comorbidities) to optimize the ERAS protocol (Enhanced Rehabilitation After Surgery).~     Thus, this analysis will allow the investigators to provide patients with physical~     rehabilitation programs a la carte during a hospitalization for colorectal surgery.~     Connected bracelets will directly involve patients in their care and rehabilitation.~   "
73050|NCT02610777|"~     The purpose of this study is to evaluate the efficacy and safety of pevonedistat plus~     azacitidine versus single-agent azacitidine in participants with higher-risk myelodysplastic~     syndromes, chronic myelomonocytic leukemia and low-blast acute myelogenous leukemia.~   "
73051|NCT02610764|"~     To investigate the feasibility of evaluation of prevalence and clinical significance and~     relevance of circulating tumor cells (CTC) in the blood of patients with resectable~     adenocarcinoma of the esophagus (EAC) treated with multimodal therapy in a pilot study. The~     primary hypothesis is that the number of CTC correlates with tumor burden and response to~     treatment. One established and one experimental CTC detection platform will be investigated.~     Investigators will evaluate the prevalence and enumeration of CTC before neoadjuvant~     treatment (time point 1), after neoadjuvant treatment & before operation (time point 2) and~     after the operation (time point 3). Results will be compared with healthy controls (one time~     point) and correlated with conventional response to treatment evaluation. The persistent~     presence of CTC could be a marker for worse response to treatment and predict early~     recurrence.~   "
73052|NCT02610751|"~     -  The investigators hope their study will answer the question of whether or not fetal~          testosterone levels are increased in female newborns exposed to nicotine as a result of~          maternal smoking during pregnancy. Secondarily they plan to also evaluate maternal~          cotinine and testosterone levels and newborn anogenital distance, second digit to fourth~          digit (2D:4D) finger length ratio, newborn length and birth weight.~        -  The investigators hope by performing this study, they will help to uncover the effect of~          tobacco exposure in utero on human female fetal testosterone levels, thus improving the~          counseling for tobacco use in pregnancy.~   "
73053|NCT02610738|"~     The aim of this study is to develop educational packages for children of primary school age~     with type 1 diabetes and their parents, and to undertake a small scale feasibility study to~     allow evaluation of the curriculum. Paediatric diabetes teams in the United Kingdom currently~     deliver education using largely unevaluated teaching materials. By working with the education~     profession the investigators aim to develop packages which are based on recognised~     educational theory and practice. The investigators hope that use of these will result in~     better blood glucose control, reducing the risk of longterm diabetes complications such as~     eye and kidney disease.~   "
73054|NCT02610725|"~     We are seeking to understand the acceptability of an online yoga class for individuals with~     mood disorders. MoodNetwork members who are 18 years old or over who have experienced~     depression, mania, or hypomania are invited to participate. About 200 MoodNetwork~     participants will take part in this study.~   "
73055|NCT02610712|"~     The purpose of this study is to determine the efficacy of the use of intravenous low-dose~     ketamine in the treatment of treatment-resistant depression (TRD), as well as the changes in~     Glutamate neurotransmission and inflammatory serum markers.~   "
73056|NCT02610699|"~     Ear infections, or otitis media, are a leading cause of health expenditures and antimicrobial~     prescriptions in children. Diagnosis of otitis media requires the ability to view the~     tympanic membrane. An instrument called an otoscope with a light source and a magnifying lens~     with a plastic tip that conforms to the ear canal is currently the standard of care for~     examining the tympanic membrane. Interpretation of otoscopic examinations is~     operator-dependent and cannot be seen by anyone other than the person holding the otoscope. A~     pocket size attachment that uses the technology and light source of a smartphone to capture~     images of the ear canal and tympanic membrane facilitates image documentation of the otic~     examination. In previous studies with the device, the investigators have shown that image~     quality of photographs of the tympanic membrane taken with the smartphone otoscope are~     equivalent to those taken with a camera-fitted conventional otoscope.~      In this study, the Community Provider Assessment Study (CPAS), the investigators will perform~     a cross-sectional study in which they will randomly assign 3-4 pediatricians to use a~     smartphone otoscope as the standard of care device for all ear examinations and 3-4~     pediatricians to use a conventional otoscope for alternating 1 month periods for 6 months.~     The parents of children examined during the study period with both devices will be invited to~     participate in 3 telephone surveys assessing parental satisfaction with the device and~     antimicrobial use by their child for the otic complaint. The results of this study have the~     potential to improve diagnosis and management of otitis media, thus improving patient care,~     reducing costs, and decreasing the opportunity for the development of antimicrobial~     resistance.~   "
73057|NCT02610686|"~     Understanding the extent and regional distribution of CQR vivax malaria and detecting early~     signs of resistance is critical to prevent the spread of resistant strains, optimize~     treatment guidelines, and reduce the risk of recurrent and severe malaria. In Vietnam, CQR in~     P.vivax has been reported sporadically. One study carried out in Binh Thuan province~     (central-south Vietnam) at the end of the 1990s demonstrated early P.vivax recurrences (7%)~     by Day 16 after a 3-day CQ treatment. However, in a summary report to World Health~     Organization (WHO) including data from 11 sentinel sites, from studies conducted between 2006~     and 2011 in central and southern Vietnam (total 350 patients), P.vivax is still considered~     sensitive to CQ. More recently in a cohort study conducted in Quang Nam province (Central~     Vietnam) in which P.vivax patients were treated radically with CQ and primaquine (10-day at~     0.5mg/kg/day) following national guidelines, the 28-day failure rate was measured at 3.45%~     and CQ blood concentrations measured at day of recurrence (>100ng/ml) confirmed resistance in~     three patients. The current national guidelines for the radical cure regimen of P.vivax~     infections recommends 3 days of CQ (total 25 mg/kg body weight (bw)) together with 14 days of~     primaquine at 0.25 mg/kg bw/ day.~      The current WHO protocol recommends a 28-day follow-up to assess the efficacy of CQ for the~     treatment of P.vivax infections. However, recurrence of early stage resistant parasites may~     occur after Day 28 in the presence of CQ blood levels above the minimum efficacy~     concentration (MEC, ≥100ng/ml) and relapses could occur as early as 36 days after standard CQ~     treatment. Therefore, in order to confirm CQR it is recommended to extend the follow-up~     period, to Day 42 or 63 and measure whole blood CQ level at Day 28 and at the time of~     recurrence. Moreover, it has been shown that emerging drug resistance in P.vivax is~     associated with delayed parasite clearance after treatment, i.e. some parasites are still~     detectable at Day 3. The aim of the present study is to assess the in vivo and ex vivo~     susceptibility of P.vivax to CQ in Central Vietnam following the currently recommended~     radical cure regimen and using GMP certified CQ.~   "
73059|NCT02610660|"~     The TOPP-2 registry is an international, non-interventional, prospective registry including~     children and adolescents newly diagnosed with pulmonary hypertension (PH) to gain further~     insights in the disease course and long-term outcome of PH in childhood.~      Patients will undergo clinical assessments and receive standard medical care, as determined~     by treating physicians in their daily clinical practice. The TOPP-2 registry is specifically~     designed to capture the variables that have been proposed as treatment goals in PePH and the~     reasons for changes in treatment strategy.~      The TOPP-2 registry uses the new clinical classification of PH as outlined at the 5th World~     Symposium for Pulmonary Hypertension (WSPH) in Nice 2013 and includes new characterizations~     for children with PH.~      The registry is planned and implemented under the scientific leadership of the Association~     for Pediatric Pulmonary Hypertension (PePH), independently from the financial sponsors.~   "
73060|NCT02610647|"~     The main objective of this study is to compare between groups the level of complexity of the~     estimated sensorimotor performance through multi-fractal (minmaxMF-DFA) exponents.~   "
73061|NCT02610634|"~     Parkinson's disease (PD) is associated with problems of gait such as veering, difficulty~     turning, an inability to perceive doorways or obstacles, and negotiate uneven terrain. Gait~     problems, especially veering, may be exacerbated by visuospatial dysfunction which predispose~     to falls, freezing and festination of gait. Visuospatial dysfunction is common in PD and~     likely involves peripheral features (e.g. contrast sensitivity) as well as central cognitive~     mechanisms (e.g. attention).~      Central neuro-degeneration in PD, PD dementia, and dementia with Lewy Bodies may influence~     visual function, as impaired visual sampling has been reported in these conditions. Visual~     sampling is measured via saccadic (fast eye movement) activity, as saccades are the~     mechanisms through which people orientate and explore the environment. The use of objective~     devices to reliably measure saccades is important to detect disease related eye movement~     changes. Emerging visuomotor research has measured visual sampling in PD using devices such~     as electrooculography and infra-red eye tracking, revealing reduced amplitude, speed and~     frequency of saccades during various tasks.~      Despite recent increases in visuomotor research it remains unclear how PD influences visual~     sampling of the environment during gait and the influence of attentional and cognitive~     deficits. Recent work demonstrated that people with PD sample their environment less~     frequently than controls, despite a slower gait. Saccadic timing was unchanged in response to~     environmental cues. Despite this, environmental visual cues (transverse lines on the floor)~     have been shown to increase the number of fixations made during gait. However the mechanisms~     of this response remain unclear. Cognition is likely of importance, with response potentially~     influenced by attentional control.~      This observational study aims to examine the influence of cognition on visuomotor control~     during gait in PD. This aim will be achieved by observation of visual sampling under several~     environmental challenges (straight walk, doorways, turns, visual cue) and a dual task.~   "
73062|NCT02610621|"~     Eligible patients will be female, ages 18 and older and have a diagnosis of Clinical T1 or T2~     invasive breast cancer with no suspicious palpable adenopathy. Patients will undergo standard~     of care lumpectomy without sentinel node biopsy and whole breast radiation, followed by~     chemotherapy.~      Sentinel node biopsy is also considered standard care when patients have localized breast~     cancer. Treatment can often be influenced by whether the results of the biopsy show cancer or~     not. However, the biologic factors of the primary tumor have become more important in~     determining treatment recommendations in women with clinically node negative breast cancer.~   "
73063|NCT02610608|"~     This study aims at evaluating clincal practice regarding prevention of arterial and venous~     thrombosis following ovarian stimulation.~      Secondary outcomes are : 1) to describe the incidence and risk factors of arterial and venous~     thrombosis in women undergoing assisted reproductive technology and 2)to identify the~     incidence and risk factors for ovarian hyperstimulation syndrome in these women~   "
73064|NCT02610595|"~     To evaluate the effectiveness and safety of the Chinese medicine treatment for multiple drug~     resistance of MN patients with Jianpiyiqi and Huoxuejiedu Recipe.~   "
73065|NCT02610582|"~     The purpose of this study is to proof the safety and efficacy of a single subretinal~     injection of rAAV.hCNGA3 in patients with CNGA3-linked achromatopsia.~   "
73066|NCT02610569|"~     Ulcerative colitis (UC) is an inflammatory bowel disease progressing through flare-ups. The~     therapeutic objective, which was originally based on clinical remission, is currently~     evolving with the development of biotherapies towards the achievement of endoscopic~     remission. Current recommendations for therapeutic management advocate the achievement of~     endoscopic mucosal healing (EMH), with an observed decrease in the necessity for colectomy in~     the case of EMH. Endoscopic evaluation of the severity of UC is performed during a digestive~     endoscopy (colonoscopy for a complete colonic exploration, or recto-sigmoidoscopy for a~     partial exploration of the colon) from endoscopic activity scores adapted for UC.~      Currently, the score the most commonly used is the MAYO endoscopic score. This is a global~     score of increasing intensity from 0 to 3, taking into account the following basic lesions:~     vascular pattern, granularity or/and friability of the mucosa, spontaneous bleeding, erosion~     and ulceration. However this score has limits: it does not distinguish deep cavitating~     ulcerations with mucous detachment from simple ulcerations which have a better prognosis.~      A new endoscopic score specific for UC has been developed and is currently being validated.~     It is termed Ulcerative Colitis Endoscopic Index of Severity (UCEIS). This evaluation takes~     into account the three most reproducible factors - the vascular pattern, the presence of~     bleeding, and erosions or ulcerations including cavitating ulceration - in the total score.~      To ensure optimal patient care and an adaptation of the therapeutic medical care to the~     endoscopic severity of the disease, endoscopic exploration should be performed recurrently.~     However, this exploration is an invasive procedure, requires general anaesthesia for~     colonoscopy, and can lead to potential complications such as perforation. This explains the~     poor acceptance by patients, resulting in a sub-optimal therapeutic support.~   "
73067|NCT02610556|"~     The investigators aim to evaluate the efficiency and toxicities of concurrent docetaxel and~     cisplatin with intensity-modulated radiotherapy in high risk locoregionally advanced~     nasopharyngeal carcinoma.~   "
73068|NCT02610543|"~     This is a Phase 2, multicenter, double-blind, placebo-controlled, 12-week proof-of-concept~     study to assess the efficacy, safety, and tolerability of UCB5857 in subjects with primary~     Sjögren's Syndrome (pSS).~      The primary objective of this study is to evaluate the efficacy on overall disease activity~     and safety of UCB5857 added to current treatment relative to placebo in subjects with pSS.~   "
73069|NCT02610530|"~     The SIT-DOWN study is a single centered retrospective study in which a total of 90 (ninety)~     participants who are overweight (BMI: 25-29.9 kg/m2) and have type 2 diabetes mellitus (T2DM)~     will be evaluated for the efficacy of surgical intervention in comparison with medical~     treatment. Primary endpoint of the study will be the change in glycemic regulation by the end~     of 12 months.~   "
73070|NCT02610517|"~     Phase 1: To train providers to offer alcohol pharmacotherapy to at-risk drinkers interested~     in quitting or reducing their drinking as part of overall HIV care. Phase 2: To determine the~     effectiveness of a computer-delivered brief intervention (CBI) for reducing hazardous~     drinking in the HIV clinical care setting.~   "
73071|NCT02610504|"~     Open label, prospective, single cohort study of Durolane 3ml intra-articular injection into~     the shoulder for pain in mild to moderate patients~   "
74944|NCT02585960|"~     1. To compare the efficacy and safety of PK-guided treatment with BAX 855 targeting FVIII~          trough levels of 1-3% and approximately 10% (8-12%)~        2. To further characterize pharmacokinetic (PK) and pharmacodynamic (PD) parameters of BAX~          855~   "
73072|NCT02610491|"~     Metabolic Syndrome (MS) is a well-known group of obesity-related metabolic disorders~     including insulin resistance (IR), dyslipidemia and hypertension (HTN). In addition,~     overweight has a causal relationship with a chronic low grade systemic inflammatory condition~     and increased intestinal permeability. Over the last decade, this multiplex disorder has~     progressively become a major worldwide public health problem, because of its association with~     increased risk of type 2 diabetes mellitus (DM2), atherosclerotic cardiovascular disease and~     all-cause mortality. Scientific evidence for measures to improve cardiometabolic and~     intestinal health by non-pharmaceutical means are of urgent need. Administration of the~     flavonoid hesperidin to those at risk may have beneficial effects on glucose / insulin~     metabolism, lipid metabolism, blood pressure, heart rate, pro-inflammatory and oxidative~     stress biomarkers and gut barrier function.~      Objective: To determine the 12-week effect of daily administration of hesperidin on the main~     cardiometabolic disorders related to MS as assessed by investigation of glucose/insulin~     metabolism, blood lipid profile, blood pressure, heart rate, body composition and gut barrier~     function in subjects at risk for MS.~      Study design: This is a randomized, double-blind, placebo-controlled study with parallel~     design.~      Study population: Healthy (male/female) volunteers, age 18-65, at risk for metabolic syndrome~     (presenting with 2 out of 5 of the components from NCEP-ATP-III criteria).~      Intervention: Participants will be randomly assigned to one of the intervention groups. One~     group will receive one daily dose of hesperidin capsules while the other group receives~     identical looking placebo capsules for a period of 12 weeks. The capsules will have to be~     ingested with a glass of water every morning just before breakfast.~      Main study parameters/endpoints: The primary efficacy parameter of this study is the oral~     glucose tolerance test (OGTT), a validated surrogate endpoint to study the β-cell function~     and insulin sensitivity. Secondary endpoints entail the evaluation of effects of daily~     administration of hesperidin on lipid profile (blood measurements), blood pressure and heart~     rate, body composition, low-grade inflammation biomarkers (blood measurements) and gut~     barrier function (blood measurements, fecal samples, urine collection).~   "
73073|NCT02610465|"~     Background:~      Computed Tomography (CT) scans make detailed pictures of the body in seconds. CT scans make~     pictures by passing x-rays through a person. CT scans are common. In 2011, around 85.3~     million of them occurred in the United States. Researchers think CT images can be made better~     using new techniques. Higher resolution images can be derived from the original scan.~      Objective:~      To learn if new ways of obtaining and processing pictures of the body from a regular CT scan~     can produce images with higher resolution (pixels) and more information than standard~     methods.~      Eligibility:~      People ages 18 and older who are scheduled to have a CT scan and are not pregnant~      Design:~      Participants will be screened with a review of their medical records.~      Participants will have their scheduled CT scan.~      The CT scanner used in this study provides enhanced images of inside the body. Researchers~     may use the CT scanner in a research mode to test and improve the pictures.~      Images from the CT scan will be reviewed.~      Any clinical findings from the CT test will be shared with the participant s doctor.~      Participants will continue to receive their medical care from their regular doctor.~      The CT images will be entered into an NIH research database. In the future, they may be used~     for research purposes.~   "
73074|NCT02610452|"~     The main objective of this study was to assess changes in the quality of life of patients in~     a Palliative Care Unit via the symptoms by the Edmonton Symptom Assessment System (ESAS)~     before and one hour after the passage of a clown therapist .~   "
73075|NCT02610439|"~     This research trial studies whole exome sequencing in finding causative variants in germline~     deoxyribonucleic acid (DNA) samples from patients with peripheral neuropathy receiving~     chemotherapy for breast cancer. Studying samples of germline DNA in the laboratory from~     patients with peripheral neuropathy receiving paclitaxel for breast cancer may help doctors~     learn more about changes that occur in DNA and identify biomarkers related to peripheral~     neuropathy.~   "
73076|NCT02610426|"~     This research trial studies whole exome sequencing in finding causative variants in germline~     deoxyribonucleic acid (DNA) samples from patients with congestive heart failure receiving~     therapy for breast cancer. Studying samples of germline DNA in the laboratory from patients~     with congestive heart failure receiving therapy for breast cancer may help doctors learn more~     about changes that occur in DNA and identify biomarkers related to congestive heart failure.~   "
73077|NCT02610413|"~     This research trial studies whole exome sequencing in finding causative variants in germline~     deoxyribonucleic acid (DNA) samples from patients with hypertension receiving bevacizumab for~     breast cancer. Studying samples of germline DNA in the laboratory from patients with~     hypertension receiving bevacizumab for breast cancer may help doctors learn about changes~     that occur in DNA and identify biomarkers related to hypertension.~   "
73078|NCT02610400|"~     This is a cluster randomised controlled trial with factorial study design comparing the~     impact of reactive community-based malaria interventions: 1) presumptive treatment (or TPE,~     targeted parasite elimination) versus reactive case detection (RACD), and 2) reactive IRS~     (indoor residual spraying) versus control on the incidence of malaria in Namibia.~   "
73079|NCT02610387|"~     Spasticity is one of the most common disorders in patients with central nervous system~     diseases such as stroke. Transcranial direct current stimulation stimulation (tDCS) is a~     noninvasive tool that can be used to modulate cortical excitability of the leg motor area,~     and the spinal motor circuits as well.~      Objective:The objectives of this study is to examine the efficacy of anodal tDCS combined~     with Biodex balance training on lower limbs spasticity in chronic stroke patients using~     laboratory and clinical assessments.~   "
73080|NCT02610374|"~     The primary objective is to assess the effect of short-term diet modification on the~     microbiome composition, and inflammatory/metabolic disease markers in Antiretroviral therapy~     (ART)-treated HIV-infected participants and Human immunodeficiency virus (HIV)-negative~     controls in the United States.~   "
73081|NCT02610361|"~     This study will evaluate the safety, tolerability, pharmacokinetic profile and treatment~     effect of a new drug known as BGB-283 in patients with solid tumours.~   "
73082|NCT02610348|"~     Primary Objective:~      To describe the persistence of Hep B antibodies (Ab) at 12 to 18 months of age following a~     three-dose infant primary series vaccination of either Hexaxim®/Hexyon®/Hexacima® or~     Infanrix® hexa at 2, 4 and 6 months of age following Hep B vaccination at birth.~   "
73083|NCT02610335|"~     In actual practice the patients with mild or moderate lumbar spinal stenosis symptoms receive~     an epidural infiltration and participate in kyphosis reeducation in first intention. Yet the~     kyphosis reeducation did not show a real profit in the time compared with the natural~     evolution of the pathology. The study assume that the spinal mobility reeducation will reduce~     the incidence of pain recurrences compared with the classic kyphosis reeducation.~   "
73094|NCT02610192|"~     The purpose of this study is to evaluate clinical outcomes following a single injection of~     nSTRIDE Autologous Protein Solution in females with isolated patellofemoral osteoarthritis. A~     secondary objective of this study is to document the duration of treatment effect following~     nSTRIDE injection.~   "
73084|NCT02610322|"~     Project title: A randomized controlled trial of whole soy diet in place of red/processed meat~     and high fat dairy products on metabolic features in postmenopausal women Objectives:~     Metabolic syndrome (MetS) is an escalating public health problem especially in postmenopausal~     women. Traditional whole soy foods are rich in unsaturated fats, high quality plant protein~     and various bioactive phytochemicals that could benefit on MetS. The aim of the study is to~     examine the effect of whole soy replacement diet on the features of MetS among postmenopausal~     women.~      Hypothesis to be tested: Whole soy diet in place of red or processed meat and high fat dairy~     products will significantly improve metabolic features.~      Design and subjects: This will be a 12-month randomized, single-blind, controlled trial among~     208 postmenopausal women with high risk of MetS or early MetS.~      Study instruments: After 4 weeks' run-in, participants will be randomly allocated to either~     of two intervention groups, whole soy replacement group or control group, each for 6 months.~      Interventions: Subjects in whole soy group will be required to include 4 servings of whole~     soy foods (containing 25g soy protein) into their daily diet isocalorically replacing red or~     processed meat and high fat dairy products. Subjects in the control group will remain an~     usual diet.~      Main outcome measures: The outcome measures will include the indices of metabolic features as~     well as a 10-year risk for ischemic cardiovascular disease.~      Data analysis: The changes and %change of the metabolic features at 6- and 12-month will be~     compared among the two groups.~      Expected results: Whole soy diet substitution of high saturated fat and cholesterol rich~     animal products will notably decrease the risk of MetS.~   "
73085|NCT02610309|"~     The Family Based Crisis Intervention (FBCI) is an emergency psychiatry intervention designed~     to sufficiently stabilize suicidal adolescents within a single ED visit so that they may~     return home safely with their families. This study is a randomized clinical trial of FBCI v.~     TAU in an urban Emergency Department.~   "
73086|NCT02610296|"~     The purpose of this trial is to evaluate the reduction in incidence and severity of delayed~     graft function with kidney allografts from donors >45 years after brain death (DBD).~   "
73087|NCT02610283|"~     This trial is designed to evaluate QPI-1002 versus placebo for the prevention of AKI in~     subjects who are at high risk for AKI following cardiac surgery. Half of the participants~     will receive QPI-1002 while the other half will receive placebo.~   "
73088|NCT02610270|"~     A suitable concentration of omega-3 fatty acids in relation to omega 6 is considered~     necessary for a good cell function and prevention of various inflammatory processes. Diet and~     supplementation are the fundamental procedures to achieve the reference values for several~     years. Athletes are individuals under physical stress and higher tissue restoration, while~     maintaining adequate diets they show, as the rest of humans, lower than desired levels. In~     the present study the investigators aims to determine the modification of those levels by the~     administration of two different doses of a given product, keeping the same model of diet and~     physical and competition.~   "
73089|NCT02610257|"~     Motor blocks during gait and upper limb movements (FOULs) are a disabling and common motor~     impairment in mild to severe stages of Parkinson's disease (PD). However, the main mechanism~     underlying these phenomena is still an open debate. Apart from the motor correlates,~     cognitive-attentional impairment and somatosensory deficits (especially in the proprioceptive~     system) may underlie these motor blocks. The current study aims to unravel whether the~     proprioceptive system is involved by manipulating task-relevant or non-relevant~     proprioceptive stimuli.~      Hence, the main aims of this study are:~      (i) to assess the somatosensory function in people with PD that experience freezing of gait~     FOG and (ii) to investigate the effects of manipulating both proprioception and attentional~     resources on FOUL severity.~      Forty-five people will be assigned to three age-matched groups (N=15 each): healthy elderly,~     PD patients that experience FOG (FOG+) and PD patients that do not experience FOG. Cutaneous~     sensory function and kinesthetic ability will be assessed by means of standardized~     user-friendly methods and precise repositioning measures using the VICON motion analysis.~     Additionally, participants will perform a newly developed task that can successfully elicit~     FOULs (a handwriting freezing-provoking task) on a custom tablet (Heremans et al 2015). The~     task will be performed without and with the use of muscle vibration (a well-known method to~     stimulate the proprioceptive system). The investigators will manipulate both the timing of~     vibration (relevant - after FOUL onset; or non-relevant: before FOUL onset) and the region of~     stimulation (neutral: on a bone-mark where there is little if any proprioceptive stimulation;~     and on a non-neutral spot: on the forearm muscles). It is believed that FOG+ will present~     with worse somatosensory function than those who do not experience motor blocks (especially~     in the proprioceptive system). Additionally, the Investigators expect a reduction in FOUL~     severity (e.g. FOUL duration) when vibration is applied in a task-relevant way, independently~     of the region stimulated. In contrast, it is also expected that when vibration is applied in~     a non-relevant way and it may act as a distractor, FOUL duration will increase. This study~     will thus be able to distinguish between the contribution of attentional and proprioceptive~     resources to the mechanism of motor blocks in PD.~   "
73090|NCT02610244|"~     ADHD youth (8-16 years) will be randomized to either treatment-as-usual group or a modified~     version of the Cogmed program (MCT) that is suitable for use in a hospital setting (duration~     = 3 daily 35-min sessions for 10 weeks). The main objectives are to determine whether there~     is improvement in working memory and attention, a reduction in concerns related to ADHD and~     social emotional behaviour,and transfer effects for reading and math following participation~     in our MCT.~   "
73091|NCT02610231|"~     This is a Phase 3, 52-week, open-label, flexible-dose, multinational, multicenter study to~     evaluate the safety and tolerability of istradefylline 20 or 40 mg/d in subjects with~     moderate to severe PD with motor fluctuations and dyskinesia on levodopa combination~     (levodopa/carbidopa or levodopa/benserazide) therapy plus at least one adjunctive PD~     medication. Subjects who completed 12 weeks of double-blind treatment and the 30-day~     follow-up period in Study No. 6002-014 will undergo Screening and Baseline evaluations for~     eligibility for the study. Eligible subjects will be treated with istradefylline at a~     starting dose of 20 mg/d with an option for a dose adjustment to 40 mg/d at Week 12 based on~     the Investigator's judgment of each subject's response and tolerability. If deemed necessary,~     one unscheduled dose adjustment visit between Week 2 to Week 12 is allowed in accordance with~     clinical judgment of the Investigator. Subjects who had a dose adjustment to 40 mg/d can have~     their dose decreased to 20 mg/d by the Investigator at a second unscheduled dose adjustment~     visit if there are tolerability issues. The istradefylline dose should remain fixed between~     Week 26 to Week 52. Consultation with the Sponsor's Medical Monitor is required prior to any~     unscheduled dose adjustment visits. A subject may discontinue from the study at any time.~   "
73092|NCT02610218|"~     To evaluate the clinical significance of cell free DNA (cfDNA) and circulating tumor cells~     (CTCs) in real-time monitoring the therapeutic response during HER2-targeted therapy in~     histologically confirmed HER2 positive advanced/metastatic gastric cancer.~   "
73093|NCT02610205|"~     The aim of this study was to explore participants´ subjective experiences and perspectives on~     pain and other factors of importance after an early nursing intervention consisting of~     caring touch (tactile massage and healing touch) for participants subjected to a motor~     vehicle accident with minor or no physical injuries.~   "
73096|NCT02610166|"~     Arthritis in children is a long-term illness and it can make a child's life very difficult.~     In children 8-11 years old, the child and their family work together to deal with the~     problems that arthritis can cause. Learning to cope with and manage the problems that come~     with arthritis can stop it from getting worse. It is important to create programs that teach~     children and families how to cope with and manage arthritis. This study will develop and test~     an online game that helps children learn how to better manage their arthritis. The goal of~     these studies is to test: (1) how easy to use and acceptable the online game is; and (2) if~     children who play the game feel less pain, have fewer limitations, and a better quality of~     life compared to children who do not play the game.~   "
73097|NCT02610153|"~     This prospective observational study is to assess the predictive factors of poor control of~     international normalized ratio (INR) to determine the treatment strategies received by~     patients with a poor control of INR in real-life clinical practice and to explore the~     effectiveness and safety of these strategies in patients with non-valvular atrial~     fibrillation who start vitamin K antagonist (VKA) treatment~   "
73098|NCT02610140|"~     The main purpose of the 15743 study is to assess efficacy and safety of anetumab ravtansine~     versus vinorelbine in progression free survival in patients with stage IV mesothelin~     overexpressing malignant pleural mesothelioma (MPM).~      210 eligible patients will be randomized to receive either anetumab ravtansine every three~     weeks or weekly vinorelbine.~      Treatment will continue until centrally confirmed disease progression (PD) or until another~     criterion is met for withdrawal from the study. Patients will enter follow up phase to~     capture safety and endpoint data as required.~      Efficacy will be measured by evaluating progression free survival from randomization.~     Radiological tumor assessments will be performed at defined time points until the patient's~     disease progresses.~      Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival~     or fresh biopsy tissue may also be collected for central pathology review and biomarkers.~   "
73099|NCT02610127|"~     The overall objective is to enroll patients with acquired hemophilia A (AHA) who are~     prescribed and treated with Obizur, to assess safety, and to describe factors related to~     safety, utilization and effectiveness in a real-world setting.~   "
73100|NCT02610114|"~     It is the aim of this trial to use a new computerized cell selection method, in addition to~     the current and world-wide used scoring system of fertilized oocytes implemented by Scott, to~     determine whether this leads to an increase in pregnancy rates in women undergoing assisted~     reproductive techniques.~   "
73101|NCT02610101|"~     The goal of any research study is to answer questions. The investigators are doing this~     research study to answer questions about a nutritional therapy called the Specific~     Carbohydrate Diet (SCD) for children with active Crohn's Disease (CD). The SCDiet is a diet~     where all grains such as wheat, barley, corn, rice are restricted. Most dairy products~     (except certain yogurt) are also restricted. The diet mainly consists of meat, fruits,~     vegetables, nuts, oils and honey, and is offered to individuals with active Crohn's disease~     as part of standard of care at Seattle Children's.~      For this study, the investigators will have three different dietary groups: 1.) Traditional~     SCD diet group 2.) Modified SCD to include oatmeal and rice 3.) SCD with whole foods without~     added sugar, specifically, the investigators want to know:~        -  Is the SCD well tolerated?~        -  Is SCD effective for the treatment for active Crohn's Disease?~        -  Will the results from the varied three dietary groups have the same results for each~          patient?~   "
73102|NCT02610088|"~     The investigators set up a clinical trial to compare effect of dapagliflozin, a sodium~     glucose co-transporter 2 inhibitor, with gliclazide on vascular function in patients with~     type 2 diabetes~   "
73103|NCT02610075|"~     This Phase Ib study will identify the Maximum Tolerated Dose (MTD) of AZD1775 monotherapy~     when administered orally once daily (QD) or two times per day (BID) on Days 1 to 5 followed~     by 9 days of rest in 14-day cycles, or QD on a 5/2 dosing schedule (5 days on, followed by 2~     days rest) in 21-day cycles in patients with locally advanced or metastatic solid tumours.~     Alternative treatment schedules may be explored if preliminary data suggest these would be~     more appropriate.~      The effect of food on single dose PK of AZD1775 will be assessed in 12 patients. In this~     sub-study, patients will receive a single oral dose of AZD1775 with 240 mL of water, once in~     the fasted state and once following a high-fat meal.~   "
73104|NCT02610062|"~     The purpose of this study is to evaluate the safety and tolerability of AGS67E in subjects~     with acute myeloid leukemia (AML) and determine a safe dose for future development. In~     addition, this study will assess the pharmacokinetics (PK), the immunogenicity, and the~     anti-leukemic activity of AGS67E.~   "
73105|NCT02610049|"~     This is a randomized, controlled trial of adjunctive art therapy during cognitive processing~     therapy for PTSD.~   "
73106|NCT02610036|"~     The purpose of this study will be the assessment of microangiopathy determined by the~     increase of capillary basement membrane thickness and decrease of capillary lumen area in the~     foot ulcer of 30 neuropathic and 30 neuroischemic type 2 diabetic patients~   "
73107|NCT02610023|"~     Fruits and vegetables are an important source of many different phytochemicals that may~     affect health and accurate dietary assessement tools to quantitate dietary intake are~     essential. This study will evaluate the correlation of dietary carotenoid intake estimated~     from two common and one novel food frequency questionnaire (FFQ) with estimated carotenoid~     intake from 3 day diet records as well as measured blood and skin concentrations of~     carotenoids. This study will be conducted in healthy adults. These tools may be effective in~     estimating the level of these compounds in an average diet.~   "
73117|NCT02609893|"~     This project is a randomized trial of two strategies to treat persons with genotype 1 HCV who~     currently inject drugs (PWIDs) with a once daily regime of ledipasvir-sofosbuvir (LDV-SOF)~     for 8 weeks. The study will enroll 30 participants and will assess the feasibility and~     acceptability of treating active PWIDs for HCV with LDV-SOF by modified directly observed~     therapy (mDOT) versus unobserved dosing, with motivational interviewing based adherence~     support; and assess through in-depth, semi-structured qualitative interviews, the challenges~     with time intensity required for mDOT and unobserved dosing interventions, and identify key~     factors affecting treatment adherence.~   "
75118|NCT02583685|"~     This is a prospective, randomized study to evaluate the efficacy and safety of switching~     treatment from Peg-interferon and Ribavirin to direct-acting antiviral agents in Chinese with~     CHC genotype 1b infection, who are interferon/ribavirin-intolerant.~   "
73108|NCT02610010|"~     A prior phase III randomized trial showed considerable survival benefit from the combined~     treatment of cisplatin-based concurrent chemotherapy and two-dimensional conventional~     radiotherapy (2DCRT) for patients with stage II (the Chinese 1992 staging system)~     nasopharyngeal carcinoma. However, since intensity-modulated radiotherapy (IMRT) was known to~     be superior to 2DCRT in local control, progression free survival and even overall survival,~     it is a pivotal question whether stage II [T1N1M0 and T2N0-1M0, based on the 2010~     International Union against Cancer/American Joint Committee on Cancer (UICC/AJCC) staging~     system] patients can still obtain significant benefit from the additional concurrent~     chemotherapy in the IMRT era.~      The investigators' retrospective study (PMID:26528755 ) indicated that low risk~     nasopharyngeal carcinoma (T1N1M0, T2N0-1M0 or T3N0M0, the 2010 UICC/AJCC staging system)~     patients who underwent IMRT could not benefit from cisplatin-based concurrent chemotherapy.~     Therefore, the investigators perform this randomized controlled trial to address this~     question, on a prudent assumption that IMRT alone was not inferior to IMRT plus concurrent~     chemotherapy in stage II patients.~   "
73109|NCT02609997|"~     Rapid advances of cataract surgery techniques and intraocular lens (IOL) technology have~     enabled the transition of cataract surgery from blindness relief to refractive correction. An~     ideal IOL is the critical component to achieve the refractive target of cataract surgery.~     Biocompatibility, rate of posterior capsule opacification (PCO) and visual quality have all~     been suggested as the critical factors of an ideal IOL and widely investigated. Recently,~     stability of IOL position has also been suggested as one of those critical factors due to its~     close correlation with postoperative visual function. Data suggests that IOL forward movement~     of 0.29 mm along the visual axis is associated with -0.4D myopic shift. Wang and colleagues~     recently reported that 0.5mm decentration of an aspheric IOL could eliminate its~     aberration-correcting effect. Poor stability could even lead to IOL exchange, an additional~     surgery that put both surgeons and patients in pain.~      As the supporting element of an IOL, the haptics are crucial to keep the IOL in place.~     Various haptic designs are being compared in terms of position stability of IOLs. Haptic~     designs of single-piece versus 3-piece are often compared because they are currently the most~     commonly used types. Single-piece IOLs have soft and broader haptics which are made of the~     same material as the optic, usually hydrophobic or hydrophilic acrylic, whereas 3-piece IOLs~     have rigid haptics which are made of poly methyl methacrylate (PMMA). Clinical studies~     comparing these haptic designs have yielded controversial results regarding their position~     stability in the capsular bag, which is the most recommended site for IOL fixation in an~     uneventful cataract surgery.~   "
73110|NCT02609984|"~     This is an open-label Phase 2 randomized study that will examine the use of the study agents,~     CMB305 (sequentially administered LV305 [a dendritic cell-targeting viral vector expressing~     the NY-ESO-1 gene] and G305 [NY-ESO-1 recombinant protein plus GLA-SE]) in combination with~     atezolizumab or atezolizumab alone, in patients with locally advanced, relapsed or metastatic~     sarcoma (synovial or myxoid/round cell liposarcoma) expressing the NY-ESO-1 protein.~      CMB305 is a novel approach designed to stimulate the body's immune system to fight the spread~     and growth of cancer in patients whose tumors express the NY-ESO-1 protein. LV305 will be~     given in a prime-boost approach with G305 to induce a potentially synergistic~     immunotherapeutic response in combination with atezolizumab.~   "
73111|NCT02609971|"~     The purpose of this study is to analyze the immediate effects of two exercises protocols on~     the whole body vibration, on the strength of the thigh muscles, joint position sense of the~     knee and balance in individuals submitted to anterior cruciate ligament reconstruction.~   "
73112|NCT02609958|"~     This is a single arm, multicentre, Phase 2 study to assess efficacy and safety of ASLAN001 in~     patients with advanced or metastatic cholangiocarcinoma who progressed on at least 1 line of~     systemic therapy.~      25 evaluable patients will be enrolled in the study. After evaluation of initial response in~     the first 10 evaluable patients, Sponsor will make a decision on recruitment of an additional~     15 evaluable patients. If no response is observed, the study will stop.~      The primary objective is to assess efficacy of varlitinib (also known as ASLAN001) as~     measured by ORR (based on RECIST v1.1). The secondary objectives are to (1) evaluate the~     efficacy of varlitinib, as measured by DoR, PFS, OS and DCR, (2) assess ORR, DoR, PFS, DCR~     and OS by tumor EGFR/HER2 status, (3) assess safety and tolerability of ASLAN001 monotherapy.~     Exploratory objectives are to explore possible relationships between response to ASLAN001 and~     the protein expression levels and gene mutational status of the proteins and genes via IHC~     and PCR/Sequencing.~   "
73113|NCT02609945|"~     This study is the first study in humans with CVT-427 (zolmitriptan inhalation powder) and is~     designed to evaluate the safety, tolerability, and PK of single ascending doses of CVT-427 in~     adult healthy volunteers.~   "
73114|NCT02609932|"~     The investigators hypothesize that neutrophils and monocytes developed under the influence of~     Interferon- gamma-1b (IFN-γ-1b, Actimmune*) in vivo will display enhanced function across a~     broad range of activities related in large part to the transcriptional activation effects of~     this cytokine. The investigators will evaluate the effects of IFN-γ in healthy human subjects~     in vivo on gene expression, biologic activity markers, and functional activity of myeloid~     cells in single dose studies and in steady state studies.~   "
73115|NCT02609919|"~     Our primary outcome is to assess the safety of Dotarem in children <2 years old up to 24~     hours after Dotarem injection. Patients will be monitored for any adverse events that occur~     for 2 hours following the completion of the MRI exam. The type of event, time of onset,~     duration of symptoms, intensity of the reaction (mild, moderate, severe), causality (not~     related, probably related, related, definitely related, unclassifiable), and subsequent~     outcome (required treatment, favorable outcome, recovery with sequela, or death) will be~     documented. Parents will be given instruction sheets on who and when to call should any~     adverse event occur after discharge. Parents will be called by the radiology department the~     next day to identify any adverse events that occurred during the first 24 hours after~     discharge from the hospital.~      Our secondary outcome is to assess image quality of the exam. The pre-contrast images will be~     compared to the combined pre- and post-contrast images following administration of Dotarem by~     radiologists who are blinded to the patients' clinical information to assess for improvement~     of image quality and delineation of structures with contrast.~   "
73116|NCT02609906|"~     Proximal humeral fractures are with an incidence of 4-5% the third most common fractures in~     the elderly. Compared to fractures of the upper limb it is the second most common fracture~     after distal radial fractures. 65% of all patients with a proximal humeral fracture are older~     than 60 years. Being aware of the demographic change there will even be an increase of~     incidence of these fractures. Kannus et al. showed an incidence of 298 per 100,000 in the at~     least 80 years old patients in 2007. Palvanen et al. predict an increase of incidence of 50%~     until 2030.~      Approximately 80% of all humeral fractures are minimally or non-displaced and can be treated~     conservatively with a good functional result. In 20% of humeral fractures there is an~     indication for surgical treatment according to the modified Neer-Criteria. These criteria are~     fulfilled if there is an angulation of at least 45 degrees between fracture fragments, a~     displacement of the humeral shaft against the humeral head of at least 1 cm or a dislocation~     of the tuberculum of at least 5 mm.~      Up to now there is evidence for superiority of any surgical treatment in literature. At the~     moment the most frequently used surgical technique for treatment of proximal humeral~     fractures is the angle stable plate fixation. There are various publications concerning this~     topic published by the investigators research group. In their 10-years results a majority of~     patients showed excellent and good, but also 16% showed unsatisfactory results after locking~     plate fixation. Main risk for poor outcome was revision surgery caused by secondary~     displacement (14%) which is also confirmed by results of other studies. In a further study~     investigators could show that there is a higher risk for secondary displacement in~     2-part-fractures with a gross primary dislocation or a large metaphyseal fracture zone (AO~     11-A3), especially in osteoporotic patients. More over these are common fractures and because~     of that a problem in surgical treatment.~      A secondary varus dislocation of the head fragment and cutting-out are the most common~     complications of angle stable locking plates in AO 11-A3 fractures of the elderly. The~     primary reason for this mechanism of failure is certain instability of transmetaphyseal~     fractures in the region of the surgical neck caused by loss of impaction in a porous~     spongiosa. Because of that the forces on the head screws are high while the so called~     screw-bone-interface is rather weak after a surgical treatment.~      Currently there exist various approaches to avoid a failure of the primary screw~     implantation. One possibility to increase the stability of the screw-bone-interface is the~     cement augmentation of the screw tips. To date there exist no clinical study that reports the~     results of locking plate fixation and the augmentation of cannulated head screws although it~     is a widely used method in everyday surgery, especially in the elderly.~      A second possibility to prevent secondary displacement after surgical treatment of~     2-fragment-fractures is the use of an intramedullary nails. A further development of~     intramedullary nails is multiplanar nailing. Screws can be inserted in various different~     levels and directions which can lead to a clearly higher stability.~      A comparison of these two treatment options augmented locking plate versus multiplanar angle~     stable locking nail in 2-part proximal humeral fractures has not been carried out up to now.~   "
73118|NCT02609880|"~     Gynecologic cancers cause substantial morbidity and mortality among women. Developing,~     implementing, and disseminating interventions that reduce morbidity and mortality secondary~     to gynecologic cancers are a public health priority. In spite of this, there is a paucity of~     research examining the effects of psychosocial interventions on patient-centered and~     physiological outcomes in this population. To the extent that psychological factors may~     influence quality of life and tumor biology among women with gynecologic cancers,~     psychological interventions may represent an important adjunct to standard clinical care in~     this population. As such, this study will examine the effects of a psychosocial intervention~     on sleep, pain, mood, cortisol, and cytokines in women with gynecologic cancers.~   "
73119|NCT02609867|"~     The purpose of this study is to evaluate the safety and short-term effectiveness of~     implantation of 'Flowise Cerebral Flow Diverter' for the treatment of unruptured wide-necked~     cerebral aneurysm in the internal carotid artery.~   "
73120|NCT02609854|"~     ZetrOZ's Ultrasonic Diathermy device is intended for use as a portable and wearable medical~     device which, when applied to various areas of the body applies Low Intensity Therapeutic~     Ultrasound (LITUS) to deep tissues. This device is FDA-cleared for pain reduction, treatment~     of muscle spasm and joint contracture, and increasing local circulation. This study will look~     at the use of therapeutic ultrasound to relieve pain and reduce disability in subjects with~     chronic low back pain, a subset of which will have chronic low back pain due to a herniated~     disc, over an 8-week treatment period.~   "
73121|NCT02609841|"~     This study assesses serum potassium and cardiac rhythm trends in subjects with end stage~     renal disease (ESRD) who are on 3 times weekly maintenance hemodialysis for at least 60 days.~     Dialysate K (relative potassium concentration in dialysate) must be stable for 2 weeks prior~     to enrollment.The number of subjects on 3K or higher dialysate will be limited to 60, with~     the remainder of the subjects on 1K or 2K dialysate.~   "
73122|NCT02609828|"~     The purpose of this study is to determine whether tanezumab is effective in the treatment of~     cancer pain due to bone metastasis in patients already taking background opioid therapy.~   "
73123|NCT02609815|"~     The purpose of this study is to investigate gut microbiota change and glucose lowering effect~     of initial combination therapy of gemigliptin and metformin compared to glimepiride and~     metformin in obese patients with type 2 diabetes.~   "
73124|NCT02609802|"~     The aim of this clinical trial is to evaluate the difference of analgesic potency of~     sevoflurane and desflurane at equi-minimum alveolar concentration using a surgical pleth~     index.~   "
73125|NCT02609789|"~     The purpose of this study is to assess the safety and tolerability of JNJ-55920839 following~     single ascending intravenous (IV) dose administration in healthy participants and a single~     subcutaneous dose in healthy participants and multiple IV dose administrations in~     participants with mild to moderate Systemic Lupus Erythematosus (SLE).~   "
73126|NCT02609776|"~     The purpose of this study is to evaluate the safety and pharmacokinetics, establish a~     recommended phase 2 dose (RP2D) regimens, and to assess the preliminary efficacy of~     JNJ-61186372 in participants with advanced non-small cell lung cancer (NSCLC).~   "
73127|NCT02609763|"~     This observational study will test the inter-rater and test-retest reliability of the LESS~     scale in a live context.~   "
73128|NCT02609750|"~     WorkUp is a prospective cluster randomised controlled trial in primary care. The main purpose~     is to investigate effects of early structured care based on screening of red flags (signs of~     serious medical conditions/disease), yellow flags (psychosocial factors, attitude to pain)~     and blue flags (workplace related factors) and including a workplace intervention according~     to the method Convergence Dialogue Meetings (CDM) for improving work ability, in comparison~     with treatment as usual, in patients with neck and/or back pain.~   "
73129|NCT02609737|"~     This study has 3 steps and not everyone will have all 3 steps done. The overall goals are to~     see if a new experimental drug is safe to image (step 1) and treat neuroendocrine tumors~     (step 2 and 3).~   "
73130|NCT02609724|"~     The main scientific objective of this multicentric double-blinded randomised controlled trial~     entails examining the effectiveness of fluoroscopy-guided MLD versus traditional MLD versus~     placebo MLD, applied as part of the intensive and maintenance phase of Decongestive Lymphatic~     Therapy, for the treatment of BCRL Secondary scientific objectives entail examining the~     relationship between different variables of lymphoedema at baseline~   "
73131|NCT02609711|"~     primary object : Evaluate pharmacokinetic drug-drug interaction of Candesartan and~     Atorvastatin~   "
73132|NCT02609698|"~     This clinical trial studies patients treated with the Coroflex ISAR Stent for coronary artery~     disease in order for the objective of verifying the non-inferiority of results that among~     patients who were administered DAPT for 3 months compared to patients who were administered~     DAPT for 6 months, in terms of the efficacy and safety of DAPT.~   "
73133|NCT02609685|"~     The purpose of this study is to better understand the outcomes of active surveillance~     (observation) instead of immediate surgery, which is the current standard of care for~     papillary thyroid microcarcinoma (PTMC). Patients with a 1.5 cm or smaller thyroid nodule(s)~     with papillary thyroid carcinoma will be eligible for the study.~   "
73134|NCT02609672|"~     Exercise is effective at reducing pain while improving physical function. However we do not~     know if exercise can boost resilience in the workplace, to allow people with osteoarthritis~     to work as long as they desire. Previous research shows that exercise holds the most promise~     for helping people enjoy their work because it reduces sick time, reduces pain, and improves~     productivity. However, little work has examined the effect of exercise for people with~     arthritis in the workplace. The purpose of the study is to investigate whether exercise~     improves resilience in the workplace, mobility, fitness, strength, and pain in comparison to~     no exercise in those with knee and/or hip osteoarthritis.~   "
73135|NCT02609659|"~     This study seeks to assess the safety and efficacy of treatment with~     ombitasvir/paritaprevir/ritonavir and dasabuvir with low-dose ribavirin in non-cirrhotic,~     genotype 1a (GT1a) hepatitis C virus infected participants who are treatment-naïve or~     treatment-experienced with Interferon (IFN) or Pegylated Interferon (pegIFN) with or without~     Ribavirin (RBV).~   "
73147|NCT02609503|"~     This study is being done to evaluate the efficacy of Pembrolizumab, concomitant with and~     following standard of care definitive radiation, for locally advanced squamous cell carcinoma~     of the head and neck patients who are not good candidates for Cisplatin.~   "
73136|NCT02609646|"~     The purpose of this study is to investigate the pharmacokinetic properties in critically ill~     patients of a few of the most used antimicrobial drugs (amikacin, linezolid, meropenem,~     piperacillin/tazobactam, vancomycin). The primary objective is the identification of the~     clinical parameters affecting the kinetics of these drugs and the study of the contribution~     of extracorporeal depuration techniques to the elimination of these molecules. The secondary~     objective is to describe and compare the therapeutic therapies adopted in the Intensive Care~     Units participating in the project.~      For each molecule, the study will involve 300 patients admitted to Intensive Care Units. For~     each patient five blood samples will be collected on average, in order to measure drug plasma~     concentrations. Patient clinical conditions will be collected through an electronic clinical~     record. Finally, on the basis of those data, pharmacokinetic models will be developed to~     describe the evolution in time of drug plasma concentrations.~   "
73137|NCT02609633|"~     This interventional, 6-month post-marketing study is designed to evaluate the change in~     diabetes-related distress among parents/caregivers of school-age children and adolescents~     with type 1 diabetes (T1D) who are receiving multiple daily injections (MDI) therapy.~     Investigational sites will be assigned using cluster randomization, with approximately 10 to~     20 children at each site. In order to maintain a true control group for comparison, the~     investigational sites will be randomly assigned to the Accu-Chek® CONNECT Diabetes Management~     System (DMS) or usual care/continued use of current DMS devices.~   "
73138|NCT02609620|"~     This study is designated to test the safety and initial efficacy of the LunGuard's PFT device~     for reduction of GER.~      Enterally-Fed, Sedated and Mechanically Ventilated Critically Ill Patients in the ICU will~     have the PFT positioned in them and used for feeding of a Nutritional Formula.Samples will be~     taken by suction on predetermined intervals and analysed for Pepsin A concentration.~      The PFT will be removed upon completion of the study's scheduled routine. Patients in the~     control group will have a standard polyurethane nasogastric device inserted according to~     standard procedure, which is considered the gold standard.~   "
73139|NCT02609607|"~     The investigators seek to test whether incorporating the scheduled dosing of a bisacodyl 10~     mg rectal suppository every other day improves bowel-related symptoms in patients with~     multiple sclerosis. Patients will be randomized to receive either a placebo suppository or~     bisacodyl suppository dosed every other day for 4 weeks.~   "
73140|NCT02609594|"~     Lower extremity ulcers pose significant clinical, humanistic and economic burdens on society.~     Millions of Americans are afflicted with painful, open, draining sores on their lower~     extremities. These sores are referred to as venous leg ulcerations (VLUs).1-5 Under the best~     of circumstances these ulcers require weeks or months to heal. Not uncommonly wound care~     specialists see patients who have suffered for years or faced amputation of the limb as their~     only option to alleviate the pain.~      Standard of care will result in healing in 50% of venous leg ulcers in 12 weeks. However,~     roughly half of patients suffering from venous ulcers will require advanced therapy. Human~     amniotic membrane replaces the damaged extracellular matrix characteristic of chronic ulcers.~     In addition, it contains cytokines that may accelerate healing. In clinical practice and~     recent studies, Dehydrated Human Amniotic Membrane has appeared to be as effective as~     bioengineered skin products. This RCT is designed to evaluate Amnioband Dehydrated Human~     Amniotic Membrane in venous leg ulcers.~   "
73141|NCT02609581|"~     To expand knowledge on the application and tolerability of immunotherapy with LAIS® Mites~     allergoid tablets as well as knowledge on the alleviation of symptoms during sublingual~     therapy in special consideration of the chosen titration schedule in everyday practice.~   "
73142|NCT02609568|"~     By studying individual biomarkers in body fluids such as saliva, there is a potential for~     detecting injury to the brain resulting from an acute traumatic even that may not be~     detectable by conventional neuroimaging like CT scans.~   "
73143|NCT02609555|"~     Curvilinear incision in the postanal space, through the intersphincteric plane, insertion of~     Proctoscope of TEM technique and dissection till sacral promontory, insertion of mesh between~     the rectum and sacrum, post anal repair then anal cerclage width absorbable suture.~   "
73144|NCT02609542|"~     The disorder of oral language development is defined by the delay in language acquisition in~     children who possess efficient auditory acuity and normal non verbal intellect.~      The diversity of language developement disorders depends either in the expressive level or in~     the receptive level leading to divers syndromes and symptoms. These syndromes and symptoms~     are regrouped under the name of STOL (Specific Troubles of Oral Language).~      In the current project the visual exploitation and learning capability of children presenting~     a STOL condition will be compared to patients with a normal development. The investigator's~     hypothesis is as follows: STOL patients for whom the STOL disorder is reduced between 4 and 7~     years of age will present a better performance at verbal memorisation, compared to patients~     with a persistent STOL condition after the age of 6.~   "
73145|NCT02609529|"~     IBS is the most common diagnosis in new patients in our pediatric gastroenterology clinic,~     accounting for 36 % of all new patients. Pediatric IBS patients always have a problem with~     defecation, characterized either as diarrhea predominant or constipation predominant. About~     one third of pediatric IBS subjects have d-IBS. There are no FDA approved treatments for~     children with d-IBS. There is evidence that diarrhea predominant irritable bowel syndrome~     d-IBS may be caused by a mild inflammation in the intestinal lining. Oral serum-derived~     bovine immunoglobulin protein isolate (SBI) is a medical food, believed to treat mild~     inflammation in the small intestine associated with some cases of d-IBS, especially those~     arising after acute gastroenteritis. It improved pain and diarrhea in adults with d-IBS. Our~     aim is to determine if SBI improves the number of spontaneous bowel movements in children~     with d-IBS.~   "
73146|NCT02609516|"~     Life expectancy at age 65 in the most deprived fifth of the English population was about 4~     years shorter than of the most affluent fifth in 2010. The inverse gradient between mortality~     and social position is well established. But how disease patterns and multimorbidity (having~     two or more long term conditions at the same time) impact on differential mortality rates is~     inconclusive: is it because disadvantaged groups acquire more or more lethal combinations of,~     diseases over their life course; or, simply, become ill at ages younger than more affluent~     groups?~   "
73148|NCT02609490|"~     A phase 3 clinical study to evaluate the safety and efficacy of Azilsartan in Chinese~     hypertension patients~   "
73149|NCT02609477|"~     This study is to evaluate the abuse potential of single-doses of istradefylline compared to~     placebo and phentermine in recreational stimulant users. Subjects will participate in an~     outpatient medical Screening visit, a 5-day Qualification (Drug Discrimination) Phase, a~     6-period Treatment Phase, and an outpatient safety Follow-Up visit. Study will be~     approximately 25 weeks total.~      Within 28 days of the Screening visit, eligible subjects will be admitted to the CRU (Day -1)~     for the Qualification Phase. During the Qualification Phase, subjects will receive single~     oral doses of phentermine 60 mg and matching placebo in a randomized, double blind, crossover~     manner, with each drug administration separated by approximately 48 hours (Day 1 and Day 3),~     to ensure that they can discriminate and show positive subjective effects of the active~     controls. Following evaluation of eligibility, subjects may be discharged (those who fail~     Qualification criteria) or remain in the CRU (those who pass criteria and are eligible) and~     then proceed directly to the Treatment Phase. The washout interval between last drug~     administration in the Qualification Phase and first drug administration in the Treatment~     Phase will be at least 96 hours (4 days).~      Following confirmation of eligibility from the Qualification Phase, subjects will be~     randomized to one of 6 treatment sequences according to a 6x6 Williams square. Subjects will~     receive single oral doses of each of the 6 treatments in a randomized, double-blind,~     crossover manner, Istradefylline 40 mg, Istradefylline 80 mg, Istradefylline 160 mg,~     Phentermine 45 mg, Phentermine 90 mg, Placebo.~      Each drug administration will be separated by at least 21 days. Serial pharmacodynamic~     evaluations will be conducted up to 24 hours after each study drug administration to confirm~     exposure to istradefylline.~   "
73150|NCT02609464|"~     The purpose of this study is to evaluate the role of new barbed suture for closure of wound~     during total hip arthroplasty in reducing the risk for wound healing problems.~   "
73151|NCT02609451|"~     The purpose of this study is to compare the feasibility, safety, and quality of life (QOL) in~     patients (pts) undergoing protective ileostomy closure after 2 weeks with a closure after 12~     weeks.~   "
73152|NCT02609438|"~     The purpose of this study is to determine whether varying the frequency and length of~     activity breaks during the workday will differentially impact sedentary behavior and health~     outcomes. Participants will be randomly assigned to take short, frequent breaks (i.e., 1~     minute every half hour) or longer, planned breaks (i.e., two 15-minute walks) from sitting~     during the workday. They will be instructed to follow the assigned protocols for an 8-week~     intervention and the effects of their participation on sedentary behavior and a variety of~     health outcomes will be assessed. The investigators anticipate participants in both~     intervention arms will demonstrate significant reductions in daily sitting time, bit do not~     have an a priori hypothesis regarding the relative effectiveness of each approach.~   "
73153|NCT02609425|"~     Determine the safety and efficacy of novel suture in esophageal anastomosis. Specific Aims:~     1) Determine the safety of using STRATAFIX suture in esophagogastric anastomosis by measuring~     anastomotic leak rate; and 2) Determine efficacy of STRATAFIX suture in esophagogastric~     anastomosis by measure anastomotic stricture rate.~   "
73154|NCT02609412|"~     Latent myofascial trigger points (LMTRP) which impair neuromuscular performance occur in~     both, patients and asymptomatic subjects. As evidence suggests that LMTRP can transform into~     active trigger points, therapy seems warranted. Besides other modalities, self-massage using~     foam rollers (self-myofascial release) has been applied as a treatment. However, there is no~     data on the efficacy of this method concerning LMTRP. Thus, the present study aims to~     evaluate the effects of different forms of self-myofascial release on LMTRP pain.~      Healthy patients with LMTRP in the calf are randomly allocated to one of three groups: 1) 90s~     static compression of the most sensitive LMTRP by means of the foam roll, 2) dynamic~     self-myofascial release rolling back and forth on the calf muscles for 90s using a foam~     roller, 3) placebo laser acupuncture of the most sensitive LMTRP. All subjects participate in~     a familiarization session with the foam roller one week prior to treatments. As an outcome,~     pressure pain threshold is assessed with an algometer. The investigators hypothesize, that~     static compression can reduce pressure pain of LMTRP more effective than dynamic~     self-myofascial release. The investigators further expect that placebo treatment will be the~     least effective method.~   "
73155|NCT02609399|"~     This pilot study is designed to demonstrate the feasibility of utilizing Emergency~     Departments (EDs) as a primary site for subject enrollment in clinical trials evaluating~     influenza therapeutics, and to provide pilot data for future clinical trial design and~     planning.~      Primary Objective: To prospectively enroll high-risk subjects with laboratory-confirmed~     influenza into a randomized, open label study of oral versus IV influenza therapeutic to~     include symptom evaluation and outcome assessments.~      Secondary Objective 1: To identify influenza positive patients utilizing a previously~     established triage-based assessment and rapid testing algorithm for suspected influenza~     infection.~      Secondary Objective 2: To retrospectively evaluate all potentially eligible patients for~     potential enrollment biases.~      Secondary Objective 3: To create a repository of residual nasopharyngeal samples collected~     from ED patients with suspected influenza illness.~   "
73156|NCT02609386|"~     The purpose of this study is to determine whether a pre-operative regimen of the study drug,~     IRX-2, a human cell-derived biologic with multiple active cytokine components, plus a single~     dose of cyclophosphamide, followed by 21 days of indomethacin, zinc-containing multivitamins,~     and omeprazole is active in treatment of oral cavity cancer. The regimen is intended to~     stimulate an immune response against the cancer.~   "
73157|NCT02609373|"~     Shift work with circadian disruption has been linked with increased breast cancer incidence.~     The mechanisms for this effect are not yet completely understood.~      This study evaluates the impact of a previously developed sleep intervention in shift workers~     at risk of breast cancer; and assesses mediating variables that may explain the relationship~     between shift work and breast cancer.~      A sample of women night shift workers were provided with a sleep intervention. The~     intervention is a standard approach used in a sleep clinic and is delivered by telephone by a~     trained intervener.~      Hypothesis: The intervention will improve sleep in women night shift workers, which will in~     turn have a positive impact on biological and behavioural risk factors associated with breast~     cancer and quality of life.~   "
73172|NCT02609178|"~     The purpose of this study is to compare among different designs of the occlusal surface of~     artificial crowns, trying to determine a guidance of fabricating artificial crowns with~     better mimesis of the original tooth crown in terms of morphology.~   "
73158|NCT02609360|"~     Crystalloid solutions modify acid-base equilibrium according to their electrolyte~     composition. Moreover, it has been suggested that these alterations are generated by the~     difference between the solution strong ion difference (SID) and the plasma bicarbonate level.~     An increased risk of acute kidney injury and renal replacement therapy has been associated to~     the infusion of chloride rich crystalloids. This study aims to compare, in patients with~     acute respiratory failure undergoing ECMO support, the effects on acid-base status and renal~     function of crystalloids commonly employed for circuit priming to a balanced solution created~     with a SID equal to patients' bicarbonate level.~   "
73159|NCT02609347|"~     The aim of this randomized controlled trial is to assess if manual therapy improves mobility,~     gait, and balance more than a control group for patients who have undergone open reduction~     internal fixation (ORIF) after an ankle/hindfoot fracture.~   "
73160|NCT02609334|"~     This is a double-blind, randomised, placebo-controlled, cross-over, Phase 2 trial evaluating~     two doses (a low and a high) of CRD007 for the treatment of asthmatic trial subjects with a~     positive asthma test (mannitol challenge) prior to enrolment.~   "
73161|NCT02609321|"~     Surgical treatment of breast cancer is frequently associated with postoperative pain in the~     surgical area. Persistent pain after breast cancer management has considerable negative~     effects on the quality of life of survivors. The aim of this trials is to evaluate the~     efficacy of thoracic paravertebral block with bupivacine 0.5% in reducing the acute pain~     postmastectomy compare with surgical wound infiltration with bupivacaine 0.5%.~   "
73162|NCT02609308|"~     Lateral ankle sprains are one of the most common in sports medicine. Considering the sprains~     in general, they represent an 85% of the ankle lesions. The incidence in high performance~     athletes range from 16 to 21%. It is estimated that 10,000 to 25,000 peoples suffers a~     lateral ankle sprain per hour in the United States. The objective of the treatment is to~     normalize the articular function and allow the patient to return to his or her normal~     physical activities. Platelet rich plasma is a simple of autologous blood with concentrations~     of platelets above baseline values. This is rich in platelet derived growth factor which~     stimulates cell replication, angiogenesis, transforming growth factor B1, fibroblast growth~     factor, epidermal growth factor, and insulin like growth factor. The risks of its~     applications are minimal and are usually involved with allergic reactions to other~     medications that are applied in combination with the platelet-rich plasma.~      To establish that the use of platelet rich plasma and immobilization with a short leg cast in~     acute lateral ankle sprains will enhance an early recovery in comparison with just~     immobilization with the cast.~   "
73163|NCT02609295|"~     This study evaluates whether ALA intake alters total cholesterol and homeostatic factors and~     the relationship between these alteration and lipoprotein associated phospholipase A2~     (Lp-PLA2) activity.~   "
73164|NCT02609282|"~     This study aims to investigate whether hourly prompts, delivered by Microsoft Office onto the~     PC's of office workers, is effective at reducing unhealthy patterns of sedentary behaviour .~   "
73165|NCT02609269|"~     To prospectively evaluate the utility of genomic expression data as a tool to better~     characterize the tumors of individual patients, and to understand how genomic information~     from individual patients undergoing routine clinical testing can be used in population-level~     analysis to improve treatment and outcomes.~   "
73166|NCT02609256|"~     Malignant middle cerebral artery infarction(MMCI) has a high rate of disability and~     mortality. At present, there is no effective treatment except for craniotomy decompression,~     but the controversy of the craniotomy decompression still exists. The project is a~     prospective, randomized, single center, open label, clinical controlled trail. The eligible~     patients for enrollment are as follows: (1) malignant cerebral artery infarction within 48h~     onset; (2) craniotomy decompression can not be performed due to the contraindications, or~     refused by the patient or relatives. The patients are randomly assigned into 2 groups:~     (1)Medical therapy group: receiving osmotic therapy with mannitol and glycerol~     fructose，anti-platelet treatment, statins, and other symptomatic treatments such as~     controlling blood pressure, blood sugar, and infection, tracheal intubation or incision, etc;~     (2) Stereotactic infarct tissue aspiration (SITA) group: on the basis of medical treatment,~     receiving minimally invasive aspiration of infarct tissue 24-48 hours after stroke attacked.~     This study is aimed at comparing the efficacy and safety of of SITA in patients with MMCI.~   "
73167|NCT02609243|"~     Prediabetes, defined by either impaired fasting glucose and/or impaired glucose tolerance, is~     a known high-risk condition predisposing to future diabetes mellitus type 2. Strategies to~     prevent progression from prediabetes to diabetes have been widely studied, however, without~     striking long-term effects of any kind of intervention (pharmacological, behavioral...). The~     investigators therefore investigate certain nutritional approaches concerning nutrient~     content and favorable food components, targeting metabolic improvement.~   "
73168|NCT02609230|"~     This study will determine the maximum tolerated dose (MTD) and/or the recommended phase II~     dose (RP2D) of single agent ONC201 in patients with advanced solid tumors or multiple~     myeloma.~   "
73169|NCT02609217|"~     The aim of this study is to gain insight in the experiences and expectations of Belgian~     parents concerning primary cesarean section. This will be achieved by structured patient~     interviews and questionnaires in 24 women undergoing the procedure and their partners. This~     group will be divided into two subgroups of 12 multiparous and 12 nulliparous women and their~     partners.~   "
73170|NCT02609204|"~     The main goal of the study is to compile a normative database for the Neuro Optic Vision~     Assessment (NOVATM) Pattern Electroretinogram (PERG) and Flash Electroretinogram (FERG)~     modules. This normalization intends to be included in a probabilistic analysis protocol to~     allow NOVATM PERG/FERG users to identify patients with results outside the normal ranges~   "
73171|NCT02609191|"~     The main objective of this study is to validate the measurement characteristics of a new bone~     densitometer, the Stratos DR:~        -  Via cross calibration to the results of body composition (BC) measurement results to~          those of a reference device (the Discover A by Hologic) in terms of body fat~          percentage, lean mass percentage of total body mass and for different subregions (left~          and right arms, left and right sides, lumbar and thoracic spine, pelvis, left and right~          legs, head, android area, gynecoid area, visceral region).~        -  And by the evaluation of the reproducibility of the BC measurement results in terms of~          fat mass and lean mass.~   "
73173|NCT02609165|"~     This study aims at investigating the therapeutic potential of recombinant human Nerve Growth~     Factor ( rhNGF ) eye drops treatment in patients with Retinitis Pigmentosa (RP) associated~     with cystoid macular edema (CME) in a phase II, randomized, double-masked, controlled~     clinical trial.~   "
73174|NCT02609152|"~     The main objective of this study is to evaluate the effectiveness of the administration of a~     short acting beta-blocker in terms of effective increase in stroke volume (at least 15%)~     after 4 hours initiation of therapy in septic shock in patients with a hyperkinetic profile~     after 12-24 hours of care.~      This research seeks to demonstrate that the proportion of patients with an increase in the~     systolic ejection superior or equal to 15% (relative to baseline) at four hours is different~     between the two arms of the study: (1) an experimental arm where patients receive an esmolol~     infusion according to a predetermined procedure and (2) a control arm where patients receive~     a saline infusion according to a predetermined procedure.~   "
73175|NCT02609139|"~     This is a Phase 1, open-label, single-dose, within-cohort randomized, 2-way crossover study~     to evaluate the PK of orally administered PF-06650833 modified release tablets under fasted~     and high fat meal fed conditions in healthy subjects.~   "
73176|NCT02609126|"~     The main purpose of this study is to understand the pharmacokinetics of EP-104IAR and to~     determine whether it is safe to use in patients with osteoarthritis (OA) of the knee. The~     study will also provide some preliminary insights into whether the experimental treatment~     reduces pain in the knee.~      Osteoarthritis is the most common joint disease, affecting over 20 million people in the US~     alone. Currently, pain treatments that are injected directly into the knee often work for~     only a short time and may also have side effects within the rest of the body. The~     experimental treatment is a steroid that is in the same family of drugs as the most common~     current injectable treatments for knee osteoarthritis. For this study, the drug is coated~     with a polymer intended to prolong the time it stays inside the knee and lessen potential~     side effects.~   "
73177|NCT02609113|"~     The purpose of this research study is to investigate if magnet therapy is effective as an~     alternative therapy for CTS.~   "
73178|NCT02609100|"~     Acute gastrointestinal bleeding is a common medical problem. When patients with~     gastrointestinal bleeding present with melena (dark, tarry stool) the blood loss is usually~     originating in the upper gastrointestinal tract (esophagus, stomach or duodenum) and first~     step in evaluating the patient is an upper endoscopy; which allows direct visualization of~     the esophagus, stomach and duodenum. However, the cause of bleeding is located in the small~     bowel or colon in 20-30% of patients who present with melena. Traditionally colonoscopy has~     been the next test preformed if upper endoscopy does not identify the cause of melena/~     gastrointestinal bleeding, however less than 25% of patients who present with melena have~     bleeding originating in the colon, and the remainder of patients have bleeding originating in~     the small intestine, which can only be fully evaluated with video capsule endoscopy (a pill~     camera which is swallowed and takes pictures while it travels thought the small bowel and~     colon). Currently patients only undergo video capsule endoscopy if colonoscopy does not~     identify the cause of bleeding. The investigators are preforming a randomized study which~     seeks to determine if colonoscopy or video capsule endoscopy is a better way to identify the~     cause of gastrointestinal bleeding in patients who present with melena and have normal~     findings on upper endoscopy. To do this the investigators will enroll patients who present~     with melena prior to their upper endoscopy and if the cause of bleeding is not identified at~     that time patients will be randomized to video capsule endoscopy (with the capsule being~     placed into the small bowel during the upper endoscopy) or next day colonoscopy.~   "
73179|NCT02609087|"~     The aim of this study is comparing the effect on cerebral oxygenation by~     sevoflurane-remifentanil or propofol-remifentanil anesthesia in patient undergoing carotid~     endarterectomy. Cerebral oxygenation is measured by near-infrared spectroscopy. Sevoflurane~     and propofol reduce the cerebral metabolic rate for oxygen in similar degree. Propofol~     decrease the cerebral blood flow by dose-dependent manner, however, sevoflurane increase the~     cerebral blood flow in the concentration of avobe 1 MAC. Both drugs are widely used in~     general anesthesia for neurosurgical procedure, and their effect on cerebral oxygenation are~     acceptable. There is little data about the effect of general anethetics on cerebral~     oxygenation in patients undergoing carotid endarterectomy, who have imparied cerebral~     circulation. Our hypothesis is sevoflurane will show better cerebral oxygenation than~     propofol in patient have impaired cerebral circulation.~   "
73180|NCT02609074|"~     Objective: The investigators initiated a pilot clinical study to test safety and preliminary~     efficacy in humans (bone tissue repairing capacity) and to evaluate standard clinical and~     rehabilitation protocols.~      Summary Background Data: Bone tissue engineering scaffolds loading growth factors have been~     considered as the most perspective among all bone substitutes, yet little progress of its~     clinical translation has been made. The concept of micro-scaffolds was proposed in this~     study to provide a trajectory to its clinical translation.~      Methods: Pre-cured CPC/rhBMP-2 micro-scaffolds have been successfully developed and further~     applied as an easy-to-operate filler for bone regeneration in a pilot clinical study.~     Patients of tibial plateau fractures, proximal humeral fractures, or calcaneal fractures at a~     similar level of severity were randomly divided into two groups and treated by CPC/rhBMP-2~     microffolds or traditional CPC paste (control group).~   "
73181|NCT02609061|"~     The present study was designed to evaluate the combined efficacy of PRF and 1% ALN in the~     treatment of mandibular degree II furcation defects when compared with PRF and open flap~     debridement (OFD) alone.~   "
73182|NCT02609048|"~     A 12-week, double-blind, randomized, placebo-controlled, Phase 2 study, to evaluate the~     effects of two doses of seladelpar/MBX-8025 in subjects with Primary Biliary Cirrhosis (PBC)~     and an inadequate response to ursodeoxycholic acid (UDCA)~   "
73183|NCT02609035|"~     ImmuSMART is a study of personalized telephonic prompts to community pharmacy patients to~     improve adult vaccination rates for pneumococcal and herpes zoster vaccines.~   "
73184|NCT02609022|"~     Study CV-0002 is the first clinical trial administering CV-MG01 in humans. This clinical~     trial is a safety and proof-of-concept study (proof of mechanism of action) intended to~     assess the safety, tolerability and immunogenic response following 3 subcutaneous injections~     of CV-MG01 as a potential therapeutic vaccine / active immunotherapy in myasthenia gravis~     (MG) patients.~   "
73185|NCT02609009|"~     Adolescent idiopathic scoliosis (AIS) affects 2 - 3% of children and adolescents older than~     10 years and is of unknown cause. It was initially thought that occurrences of back pain (BP)~     were similar to the one encounter in healthy adolescents. Recently, literature has shown that~     there is a two-fold prevalence of BP among AIS patients compared to healthy adolescents. As~     such, BP appears as a condition that might have a detrimental effect on the well-being of AIS~     patients and seems associated with increases in health care costs. Further, BP in adolescents~     would appear to be a predictive factor for adult BP. Is vertebral manipulation (VM) a viable~     alternative? Since 2006, four guidelines were in agreement as to the value of that approach~     with acute or chronic BP in adults. Unfortunately, no study was found in adolescents. The~     purpose of the study is to verify if VM is efficacious at improving AIS patients' back pain~     and to find out if it can help these patients to obtain a better quality of life and improve~     their spinal flexibility. Recruitment will take place at Ste Justine's hospital where~     patients will have 2 evaluations, conducted by an independent orthopaedist (baseline and 4~     weeks). Patients will be allocated to either the experimental (VM) or the usual medical care~     group. Spinal manipulation treatment will last over a 4-week period. The study will be the~     first trial evaluating the efficacy of vertebral manipulation in adolescent idiopathic~     scoliosis patients with back pain. Finally, no other study was found on available and~     effective treatment regarding back pain management for this population. A well-structured~     trial is needed to provide clinicians with a better understanding and best evidence regarding~     treatment protocols.~   "
73186|NCT02608996|"~     Hypertension remains a global burden in cardiovascular disease leading to stroke, myocardial~     infarction, and heart failure. Its myocardial complications result from increased mechanical~     load on the heart. Under physiological conditions of increased myocardial load and resulting~     myocardial stretch, atrial natriuretic peptide (ANP) and B-type natriuretic peptide (BNP)~     synthesis and secretion occur contributing to maintenance of optimal cardiorenal and blood~     pressure homeostasis. However, studies indicate that in subjects with cardiovascular diseases~     the biological structure of these hormones may be altered, thus reducing their favorable~     protective activities. New studies indicate that early and moderate hypertension is~     associated with a derangement of the natriuretic peptide system which is characterized by the~     lack of activation of biologically active ANP and BNP, while severe hypertension is~     characterized by cardiac release of altered molecular forms of ANP and BNP that have reduced~     biological properties and/or enhanced degradation.~      The broad objective of this proposal is to advance the biology and therapeutics of the NPs~     with a special focus on the cardiac peptide BNP in human hypertension. Our proposal is based~     upon the biological properties of BNP (i.e. natriuretic, renin-angiotensin-aldosterone~     suppressing, vasodilating, anti-fibrotic, anti-hypertrophic and positive lusitropic), its~     mechanistic role in human hypertension, and thus its potential as an innovative chronic~     protein therapeutic to enhance the treatment of patients with hypertension. Importantly, BNP~     is an endocrine hormone normally produced by the human heart, and it has been approved for~     the treatment of acute heart failure in USA.~   "
73187|NCT02608983|"~     Seaweeds are a natural source of nutrients, and dependent on the variety, are rich in dietary~     fibre, proteins, essential vitamins and minerals. However this resource is highly~     underexploited. Countries such as Japan, China, North and South Korea are large consumers of~     edible seaweed while exposure in Western countries is much lower and mainly as industrially~     extracted seaweed derivatives, a common additive in many food and healthcare products.~     Seaweeds have been associated with a number of human gut promoting health benefits such as~     decreasing faecal transit time through the gastrointestinal tract thus preventing~     constipation and resulting in a reduced exposure to harmful substances (decreasing colon~     cancer risk). These health benefits can be attributed to seaweeds high dietary fibre content.~     Interestingly, the food and healthcare industry already utilize seaweed-extracted fibre in~     the manufacturing process thus steering the way forward towards the development of novel~     functional food products. These seaweed-extracted fibres are high molecular weight~     polysaccharides known as hydrocolloids and are non-digestible by humans, hence classified as~     dietary fibre.~      Traditionally, seaweed derived polysaccharides (hydrocolloids) have been used to provide~     thickening and gelling functionality to food stuffs and other industrial applications however~     there is emerging evidence to show that lower molecular weight polysaccharides and~     oligosaccharides derived from these hydrocolloids can also act as a source of soluble fibre~     and may have prebiotic activity. Recent developments in Japan and Korea have lead to the~     commercial availability of products containing low molecular weight seaweed derived fibre.~     There is also some evidence for the beneficial effects of seaweed derived fibre in other key~     health areas such as cardiovascular health, cancer, diabetes and obesity. However, relatively~     little is known about the chemical, physio-chemical and fermentation characteristics of~     seaweed fibre in the human gut. Some hydrocolloids, notably guar gum (plant source), have~     also been employed for their health promoting properties in the areas of glucose tolerance~     and cholesterol lowering. However the use of hydrocolloids as functional food ingredients~     with health benefits for consumers has been rather limited and has focused more on uses in~     products for diabetics.~      It is particularly in the area of gut health that small and medium-sized enterprises (SMEs)~     involved in hydrocolloid production and processing, can enter the functional food ingredients~     market by using innovative processing technology. The total dietary fibre content of seaweed~     can be as high as 75% of the total dry weight and a high proportion of this is soluble. The~     fibre component essentially comprises the structural polysaccharides i.e. alginate and~     fucoidan in brown seaweeds, carrageenan, agar and porphyran in red seaweeds and ulvan in~     green seaweeds. As these fibres are primarily soluble, they form viscous gels as they pass~     through the gastrointestinal tract. Some of the fibre is fermented in the lower intestine but~     in general, soluble and insoluble seaweed fibre tends to pass through the gut without being~     digested. In its natural form as part of the seaweed plant, this fibre is typically high in~     molecular weight and passes through the gut too rapidly for the gut microflora to utilize it~     to any great extent. There is therefore a necessity to develop lower molecular weight forms~     that are more soluble and can be added at higher concentrations to food products without~     affecting the sensory properties of the product.~      The overall aim of the project is to realize an opportunity to produce low molecular weight~     polysaccharides (LMWP) from alginate- and agar-bearing seaweeds for applications in food &~     health. The two effective agar and alginate LMWPs, identified by in vitro studies, will be~     selected for assessment of prebiotic activity in a feeding trial in human volunteers (Ulster~     University) as part of an European Union (EU) study. The end points to be assessed will be~     stimulation of beneficial bacteria (bifidogenic effects), increased short chain fatty acid~     production, beneficial effects on stool formation, and improvements in gut barrier function.~     Additionally, benefits of the LMWPs towards blood glucose levels (short term and acute) will~     be assessed.~   "
73188|NCT02608970|"~     The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of~     BMS-986177 in healthy subjects~   "
73189|NCT02608957|"~     The objective of the Latella-US study is to demonstrate the safety and efficacy of the~     Latella Knee Implant System for the reduction of medial osteoarthritis pain.~   "
73190|NCT02608944|"~     This work seeks to develop, evaluate and use new MRI methods for non-invasive quantitative~     assessment of myocardial perfusion and perfusion reserve (MPR), and to compare with~     quantitative PET imaging.~   "
73191|NCT02608931|"~     This is a pilot clinical trial of dronabinol to treat disabling attacks of nausea and~     vomiting in patients with familial dysautonomia (FD, also known as Riley Day syndrome or~     hereditary sensory and autonomic neuropathy type III). FD is a rare autosomal recessive~     disease in which the growth and development of selective nerves is impaired. Patients with FD~     suffer recurrent uncontrollable nausea and vomiting crises accompanied by skin flushing,~     tachycardia and arterial hypertension. Current treatments of nausea are ineffective or have~     intolerable side sides. Our long-term goal is to treat nausea effectively and without side~     effects, a therapeutic intervention that would markedly improve the quality of life of~     patients with FD.~   "
73192|NCT02608918|"~     The purpose of the study is to assess the taste properties of HIV inhibitor~   "
73193|NCT02608905|"~     Sodium-glucose cotransporter 2 (SGLT-2) inhibitors reduce hyperglycemia and improve~     peripheral insulin sensitivity by ameliorating glucotoxicity. Insulin resistance in type 2~     diabetes (T2DM) is associated with endothelial dysfunction and vascular inflammation. Thus~     strategies to improve insulin sensitivity and lower glucotoxicity may improve endothelial~     inflammation and vascular inflammation. However, the effects of these agents on vascular~     inflammation and endothelial function is not known in patients with type 2 diabetes although~     anti-inflammatory properties have been demonstrated in various animal models. In the present~     study the investigators will assess if dapagliflozin treatment for 12 weeks decreases~     monocyte inflammation and improves endothelial function in patients with type 2 diabetes on~     metformin monotherapy.~   "
73194|NCT02608892|"~     Newborn infants have blood work procedures in their first days of life that cause pain,~     distress and physiological changes. Breastfeeding (BF), skin to skin care (SSC), or giving~     sweet solutions (sucrose or glucose) has been shown to be effective for reducing babies'~     pain. However, recent studies of neonatal pain management practices demonstrate infrequent~     use of these strategies. There is a need for parent-targeted interventions, to support~     parents' involvement in comforting their infants during painful procedures. This pilot RCT~     will inform all aspects of a full-scale trial and will evaluate the effectiveness of the~     BSweet2Babies video when shown to parents of newborns prior to newborn screening, on~     subsequent use of effective pain reduction strategies during the newborn screening blood~     test. The participants will be randomized to either the control group (usual care), or to the~     intervention group and will be shown the brief BSweet2Babies video on caring for infants~     during blood work. The intervention group will be asked to complete a second survey after~     viewing the video. To evaluate the use of BF, SSC, or sucrose during newborn screening, the~     research assistant will collect data from the electronic medical record.~   "
73195|NCT02608879|"~     The purpose of this study is to determine the effects of a novel oral care protocol on the~     severity and pain of oral mucositis in patients receiving radiation and/or chemotherapy for~     head and neck cancers. The secondary objectives are to characterize the microbiome associated~     with oral mucositis, measure salivary proinflammatory cytokines, and evaluate other clinical~     indicators of the intervention. Participants will be enrolled prior to beginning radiation~     and/or chemotherapy, and will be randomized to receive either the oral health protocol or~     standard of care oral hygiene.~   "
73196|NCT02608866|"~     The investigators proposed this randomized study to determine the feasibility of delivering~     single-fraction 16-Gy versus 3-fraction 24-Gy toward spine metastatic lesion and to evaluate~     their toxicity profiles. The investigators' analysis will provide robust data as well as~     predictive factors regarding the outcome after SSRS.~   "
73197|NCT02608853|"~     This study is conducted in the United States of America. The aim of this study is to estimate~     incidence rates of all malignant neoplasms, specific subgroups of malignant neoplasms, and~     acute pancreatitis among cohorts of antidiabetic drug users standardized to be representative~     of LEADER™ trial participants or liraglutide initiators within the Humedica Electronic Health~     Record (EHR) database.~   "
73198|NCT02608840|"~     This study will evaluate the ability of sounds played during slow wave sleep using a phase~     locked loop algorithm to enhance slow wave sleep and memory in cognitively healthy older~     adults and in those with amnestic mild cognitive impairment.~   "
73199|NCT02608827|"~     Hypertension is serious health problem in Brazil and affects almost 30%of adult population.~     It is known that there are pharmacologic and nonpharmacologic strategies for treating~     hypertension. Aerobic exercise and slow breathing are nonpharmacologic methods that reduce~     blood pressure in an isolated form, but its combinations has never been studied. The aim of~     this study is to evaluate the association of both strategies and also the mechanisms involved~     in blood pressure reduction using slow breathing, in stages 1 and 2 hypertensives.~   "
73200|NCT02608814|"~     Pleural infection is a potentially serious infection of the fluid normally found around the~     lung and current evidence suggests its incidence is increasing in both adult and paediatric~     populations.~      Identification of bacterial pathogens causing pleural infection is of paramount importance in~     the clinical care of patients are currently, only 40% of patients have a laboratory confirmed~     microbiological diagnosis for their pleural infection. An unclear diagnosis can be due to~     various reasons such as a small sample volume therefore the aim of the AUDIO study is to~     ascertain the capacity of pleural biopsies in improving the microbiological yield of pleural~     infection.~      Currently, there are no well validated methods for identifying patients presenting with~     pleural infection on the basis of initial ultrasound imaging. The AUDIO study will define the~     role of baseline thoracic ultrasound in predicting the radiographic, clinical and surgical~     outcomes of patients with pleural infection.~      The AUDIO study aims to recruit 50 patients from 2 centres with specific pleural expertise~     and these patients will be followed up over a 12 month period. Investigators hope that~     through the information gathered from ultrasound imaging and pleural biopsies, it will aid~     physicians' clinical and therapeutic decision making when treating patients with pleural~     infection.~   "
73201|NCT02608801|"~     The purpose of this study is to investigate patient related factors that contribute to~     increased risk of recurrent fractures and to investigate patient adherence to prescribed~     anti-osteoporotic drugs.~   "
73202|NCT02608788|"~     The purpose of intubation for patients under general anesthesia is to maintain their~     respiratory function. However, this procedure does cause a postoperative sore throat. Comfort~     of patients could be promoted if effective treatment could be found.~      The specific aims of this project are:~        1. Comparing the Efficacies Between the Spray of S.L. Spray Solution and Difflam to Release~          Postoperative Sore Throat.~        2. Acular spray for the prevention of postoperative sore throat.~        3. Comparing the Efficacies Between the Spray of S.L. Spray Solution and Difflam and Acular~          to Release Postoperative Sore Throat.~   "
73203|NCT02608775|"~     The primary objective of this study is to investigate the influence of a standardized noxious~     stimulus on the ANI, SPI and hemodynamic parameters during standard propofol and sufentanil~     TCI and to see if the ANI and SPI are predictive of a hemodynamic reaction.~      In addition the investigators compare the performance of ANI and SPI against one another as~     well as investigate if ANI or SPI can be used to find the ideal CeSUF for a given patient.~   "
73204|NCT02608762|"~     Background: Neurobehavioral functions and quality of life (QoL) are the important outcome~     measurements after radiotherapy in patients with brain tumors and even head/neck cancers.~     However, few studies have focused on neurobehavioral functions and QoL after anti-cancer~     treatment particularly brain radiotherapy for pediatric/adolescent patients with brain~     tumors. This study thus aims to prospectively evaluate those functions in pediatric or~     adolescent patients with brain or head/neck tumors in order to provide useful information~     about their clinical outcomes.~      Methods: A total of 72 pediatric/adolescent patients, who are diagnosed with brain tumors or~     head/neck cancers, were prospectively recruited. Neurobehavioral functions will be evaluated~     using a neuropsychological battery, which includes general cognitive functions, intelligence,~     memory, executive functions, information processing and emotional/behavioral expressions. The~     QoL will be evaluated by the health-related QoL questionnaire. All participants will be~     examined at six phases, which include pre-treatment, 1-month post-treatment, 4-month~     post-treatment, 1-year post-treatment, 2-year post-treatment and 3-year post-treatment.~      Expected results: Patients'neurobehavioral functions and QoL will show significant~     improvement after treatment, and the improvement will not be diminished across each~     post-treatment phase.~   "
73205|NCT02608749|"~     BACKGROUND: The deterioration of musculoskeletal system imposes significant impact on~     physical activity in older adults.~      METHODS: This was a randomized, parallel-group, prospective study. All participants received~     education program including home-based exercise. The IC group consisted of different~     modalities of exercise while the LEE group performed machine-based exercise. Body~     composition, muscle strength, and physical performance were measured at their baseline and 3~     months follow-up.~   "
73283|NCT02607735|"~     The primary objectives of this study are to evaluate the safety and efficacy of treatment~     with sofosbuvir/velpatasvir/voxilaprevir (Vosevi®; SOF/VEL/VOX) in adults with chronic HCV~     infection who have previously received treatment with direct-acting antiviral therapy.~      Participants randomized to placebo may be eligible for deferred treatment with active~     SOF/VEL/VOX.~   "
73206|NCT02608736|"~     This study evaluates the addition of valproic acid as a chemopreventive drug in head and neck~     squamous cell carcinoma (HNSCC) patients that do not have signs of recurrence or residual~     disease. The participants will be randomized 1:1 (valproic acid : placebo). The primary~     outcome is to document histone acetylation and DNA methyltransferase expression (DNMT) in~     saliva collected from participants when comparing valproic acid arm with placebo arm.~   "
73207|NCT02608723|"~     To check in patients suffering from chronic plantar fasciitis treated with shock wave~     therapy, if the outward appearance of the device affects clinical outcomes.~   "
73208|NCT02608710|"~     The purpose of this study is to examine the pharmacokinetic and pharmacodynamic effect of~     RDEA3170 when given as single or multiple doses~   "
73209|NCT02608697|"~     The purpose of this placebo-controlled, double-blind study is to assess the effect of several~     doses of CAT-2054 on LDL-C in hypercholesterolemic patients on a stable dose of~     high-intensity statin, and to evaluate the safety and tolerability of different doses of~     CAT-2054 for 4 weeks.~   "
73210|NCT02608684|"~     To evaluate the efficacy and safety of anti-PD-1 antibody MK-3475 (pembrolizumab) in~     combination with gemcitabine and cisplatin chemotherapy in women with recurrent~     platinum-resistant ovarian cancer.~   "
73211|NCT02608671|"~     This study will be undertaken to question the superiority of use skin adhesive tape (®~     Steri-Strip) closure system in wound healing over the traditional running absorbable~     subcuticular suture technique in perineal repair after episiotomy.~   "
73212|NCT02608658|"~     This protocol represents an open-label pilot study to assess whether oral administration of~     SBI in subjects with decompensated cirrhosis with ascites can lead improvements in the~     management of the disease. The impact of SBI therapy will be based on changes to markers of~     bacterial translocation, gut barrier damage, and inflammation as well as the impact on rates~     of SIBO. Study subjects will be given one packet of EnteraGam, each packet containing 5.0 g~     SBI, twice daily for 8 weeks.~   "
73213|NCT02608645|"~     In this study, within the secondary prevention group patients ( diabetes mellitus, coronary~     artery disease, peripheral artery disease, who have had events atherosclerotic~     cerebrovascular ) , statin use requirement , patients compliance and reaching target~     LDL-cholesterol levels (according to European guidelines ) will be evaluated.~   "
73214|NCT02608632|"~     To increase the number of responders using HFS-guided renal artery denervation (RDN) in~     patients with resistant and moderate resistant hypertension~   "
73215|NCT02608619|"~     The main purpose of this study is to discover how 18F-cholineFCH distributes in the body, and~     see if it can distinguish active histiocytes (tumor) from inflammatory (non- tumor) cells.~     This tracer has the potential to give the investigators' team more information when trying to~     identify the tumor cells that are most important to collect with biopsy. In addition, the~     study will measure levels of 18F-cholineFCH in the biopsy tissue.~   "
73216|NCT02608606|"~     After liver transplantation one of the most important cost, for both patients and their~     health insurance system, is immunosuppressive drug therapy. Tacrolimus (FK 506) is considered~     the cornerstone of immunosuppressive therapy in solid organ transplantation. Oral~     administration is the usual route, however, sublingual (SL) administration has been recently~     reported. This method of administration avoids first pass metabolism and allows an~     alternative route after transplant surgery, particularly in those patients who should extend~     the period of fasting (prolonged intubation, ileus, etc). Interestingly, in some studies, the~     dose of tacrolimus SL required to maintain similar plasma concentrations compared with oral~     administration, is significantly lower, even up to 50%, which can result in considerable~     savings in short and long term. Among these studies, only one was conducted in liver~     recipients. This study suggest that SL administration of tacrolimus could allow to obtain~     similar concentrations compared with oral administration. The design of this study did not~     assess the existence of differences in the dose required and only included six patients.~   "
73217|NCT02608593|"~     Approximately 4,000 women undergo a mastectomy for breast cancer each year in the UK and~     around 1,500 will have an immediate breast reconstruction. Approximately half of these ladies~     will have an implant-based breast reconstruction, of which many have an implant-assisted~     breast reconstruction with an Acellular Dermal Matrix.~      Strattice™ is an Acellular Dermal Matrix (a pig skin product) made by Acelity. It is used to~     cover and disguise the lower part of the breast implant. Acellular Dermal Matrices have only~     been widely used for the last eight years and long-term outcomes for women who have had this~     form of reconstruction are lacking. Despite this, it is one of the most commonly offered~     methods of breast reconstruction in the UK for both ladies with a diagnosis of breast cancer~     and in the risk-reduction setting.~      The objective of this study is to assess long-term outcomes of Strattice™-based breast~     reconstructions in multiple Breast Surgery Centres across the UK. This will be a case-control~     study comparing women who have had an immediate implant-based breast reconstruction with~     Strattice™ (case) or without (control). This will be achieved by review and analysis of~     retrospective data from patients who have undergone immediate breast reconstruction using~     implants with or without Strattice™ following either a diagnosis breast cancer or for~     risk-reduction. In addition there will be a prospective clinical assessment of the~     reconstruction outcomes. Outcomes assessed will include complications, surgical~     re-interventions and aesthetic results. These will be related to co-morbid conditions and~     other risk factors. Data will also be collected on unplanned interventions associated with a~     cost, if available.~   "
73218|NCT02608580|"~     Sickle cell disease is a genetic disease responsible for an abnormal hemoglobin.The anomaly~     has several consequences: a low hemoglobin rate (chronic anemia), plugs formed by red blood~     cells in blood vessels (extremely painful vaso-occlusive crises) and greater susceptibility~     to infections.~      Patients with this disease should be monitored medically continuously from birth. At~     adulthood, they will pass from a pediatric medical care system to an adult medical care~     system.This transition can be experienced with more or less ease, depending on the~     organization within the pediatric and adult hospitals.~      This questionnaire aims to assess the quality of the transition between pediatric and adult~     services.The investigators want to better estimate hospital work and improve the quality of~     care for this type of patients, throughout their entire medical history.~   "
73293|NCT02607605|"~     The primary purpose of this study is to compare the positive rate between the cell-free DNA~     and cytological examination of cerebrospinal fluid in Advanced lung cancer with~     leptomeningeal metastases.~   "
73219|NCT02608567|"~     In patients with asymptomatic aortic stenosis (AS), the prognostic value of reduced left~     ventricular (LV) ejection fraction is well known. Consequently, there is class I indication~     for surgery in these patients when LV ejection fraction <50%. However, there is growing~     evidences suggesting that subclinical LV dysfunction, and more particularly longitudinal~     myocardial dysfunction, may be a powerful early predictor of outcome, even when LV ejection~     is still preserved. In asymptomatic AS patients with LV ejection fraction >50%, a reduced LV~     global longitudinal strain, as assessed using speckle tracking imaging with transthoracic~     echocardiography, may be an accurate marker to identify early subclinical LV dysfunction and~     thus, to improve the risk stratification, the management and the timing of surgery. Several~     mono-centric observational small studies recently reported results emphasizing the role of LV~     global longitudinal strain in AS patients. Therefore, a meta-analysis may be conducted and~     may provide meaningful data. The investigators hypothesized that LV global longitudinal~     strain is a determinant of outcome in asymptomatic patients with AS and preserved LV ejection~     fraction.~   "
73220|NCT02608554|"~     The present study is a randomized pilot study, overweight/obese adolescent and young PCOS~     subjects will be assigned into two groups: Taichi arm and control arm. Hormonal profile and~     metabolic profile will be determined.~   "
73221|NCT02608541|"~     An observational study to derive clinically relevant and predictive rib fracture~     classification systems, based on retrospective and prospective cohorts, incorporating~     assessment of PROMs (Patient Reported Outcome Measures) and healthcare utilisation~   "
73222|NCT02608528|"~     Evaluation of FDG PET/CT to image immunotherapy response in adult thoracic cancer.~      Compare pre- and post-treatment primary tumor uptake for FDG-PET/CT and correlate with~     clinical markers of response. PET/CT tumor metabolic response will also be correlated will to~     progression-free survival and overall survival.~   "
73223|NCT02608515|"~     This non-interventional retrospective chart review study aims to evaluate the clinical~     outcomes of patients with RRMM receiving lenalidomide/dexamethasone (Len/Dex) treatment at~     1st relapse and the treatment patterns following progressive disease as part of the routine~     clinical practice in Greece.~   "
73224|NCT02608502|"~     The purpose of this study is to demonstrate the efficacy of the RSV F vaccine at a dose of~     135µg via intramuscular (IM) injection in the prevention of moderate-severe RSV-associated~     lower respiratory tract disease (RSV-LRTD) in older adults ≥ 60 years of age.~   "
73225|NCT02608489|"~     The purpose of this study is determine whether 3% diquafosol and 0.1% sodium hyaluronate are~     effective and safe in the treatment of patients with dry eye after cataract surgery.~   "
73226|NCT02608476|"~     The primary objective of this study is to determine the safety and efficacy of CB-03-01~     cream, 1%, versus the vehicle cream applied twice daily for 12 weeks in subjects with facial~     acne vulgaris.~   "
73227|NCT02608463|"~     Neuropathic pain is a common pain disorder that is caused by problems in the nervous system.~     It affects more women than men and commonly occurs in pregnancy. Physicians have little~     information to guide their treatment of neuropathic pain in pregnancy. The overall goal of~     this study is to define the course, management, and pregnancy outcomes of neuropathic pain in~     pregnancy and the acute postpartum period. It is difficult to manage neuropathic pain in~     pregnancy as treatment options must minimize their risk to the unborn child as they have a~     direct effect on infant outcomes through their exposure in utero. Thus, other treatments are~     needed. Repetitive transcranial magnetic stimulation (rTMS) may be an acceptable alternative~     to medications. Transcranial magnetic stimulation uses a magnetic force to change the way~     nerves work in the brain. This non-invasive and localized mechanism of action makes it~     attractive for use in special populations, such as pregnancy. This will be the first study to~     investigate the use of rTMS in the treatment of neuropathic pain in pregnancy. This study~     will enroll 60 pregnant subjects between the ages of 18 and 45. Participation in the study~     will last about 15 months with study visits about once a month. All participants will receive~     treatment as usual. Subjects diagnosed with neuropathic pain will be offered rTMS as a~     treatment option.~   "
73228|NCT02608450|"~     The primary objective of this study is to determine the safety and efficacy of CB-03-01~     cream, 1%, versus the vehicle cream applied twice daily for 12 weeks in subjects with facial~     acne vulgaris.~   "
73229|NCT02608437|"~     Thi pahse I, dose-escalation trial will determine the MTD, safety and the additional benefit~     achieved from adding SGI-110 to ipilimumab therapy in metastatic melanoma patients.~     Preclinical evidence generated with SGI-110 in vivo demonstrated that besides having a direct~     activity on tumor growth as a single agent, SGI-110 was able to sensitize neoplastic cells~     to the anti-tumor activity of CTLA-4 blockade, providing a sound scientific rationale to~     develop new immunotherapeutic approaches combining SGI-110 with therapeutic mAb to immune~     check-points.~   "
73230|NCT02608424|"~     In the present study, investigators test the hypothesis that a controlled mechanical pressure~     applied on specific sites of both fore-feet (ES) can reduce the inflammatory state and~     arterial blood pressure in patients with Parkinson's Disease by increasing the overall~     parasympathetic activity and reducing vascular sympathetic modulation.~   "
73231|NCT02608411|"~     This study aims to assess the role of MET inhibitors as maintenance treatment in adult~     patients with extensive stage small cell lung cancer.~   "
73232|NCT02608398|"~     Aim:~        -  The overall aims of this study to look at what changes are seen overweight and obese~          (very overweight) children, as they get thinner.~        -  Specifically the investigators are interested in the chemicals and bacteria that~          children pass in their urine and stool because looking at how these change as it tells~          us about how their gut and other bodily systems are adapting.~      Hypothesis: Metabolic profiling is a useful and accurate tool for observing and monitoring~     weight loss in children~      Study plan:~        -  To observe this weight loss process in children, the investigators will be attending a~          commercial weight loss camp called 'MORElife' which takes place every year in Leeds.~          This camp is attended by children age 8-17years who are overweight or obese, for between~          two and five weeks. It aims to help them lose weight through a structured diet,~          exercise, education and support program.~        -  The investigators plan to, with the consent of the parent and agreement the child ask if~          they would kindly give us a urine sample at the beginning and end of their time on the~          camp. For those staying longer than 2 weeks the investigators will also ask for a sample~          in the middle if possible.~        -  In addition for those children who consent, the investigators will also ask for a small~          stool (poo) sample at these same time points although there is no obligation to~          participate at all in the study and it will not affect their time on the camp whatever~          they decide.~        -  Any children who will be attending the MORElife reunion (arranged by the camp at around~          10-12 months after) who agree will be asked for a final urine and stool sample to look~          at the long-term effects.~        -  Each sample is given a code so as to remain anonymous, frozen and transported to the~          university laboratory to be analyzed.~        -  With permission and consent the investigators will also collect some information about~          the children such as, weight and height from the camp coordinators as well as samples of~          the diet that they will be fed and example of exercise activities to give a full picture~          so that results can be as accurate as possible.~   "
73233|NCT02608385|"~     Phase I to determine safety of combining stereotactic body radiotherapy (SBRT) with~     pembrolizumab in patients with advanced solid tumors. The study will determine safe doses of~     radiation by organ site when used together with pembrolizumab. The study will also provide~     the opportunity to evaluate changes in the tumor caused by SBRT.~      The study will include 2 expansion cohorts:~        -  Partially Irradiated Large Volume Tumors Cohort: Patients with at least one lesion~          greater than 65cc amenable to SBRT followed by pembrolizumab.~        -  Oligometastatic Cohort: Patients with limited metastatic disease (4 or fewer lesions)~   "
73234|NCT02608372|"~     The project is a randomized, 3-way, blinded crossover trial in which 20 healthy, fasted~     participants consume meals with 30 g of a linear corn starch and 5 g of one of the seaweeds,~     Laminara digitata or Undaria pinnatifida or a pea protein control. The primary aim is to~     investigate whether the brown seaweeds affect the postprandial glucose Area Under the Curve~     (AUC). Stomach emptying, insulin, C-peptide, appetite-regulating hormones (oxyntomodulin,~     glucagon, GLP-1 and PYY), and specific metabolites from the seaweeds in the urine and plasma~     as well as subjective satiety are also analyzed.~   "
73235|NCT02608359|"~     The purpose of this study is to evaluate the safety of abiraterone acetate in Indian~     participants with metastatic, castration-resistant prostate cancer who have been prescribed~     abiraterone acetate as per locally approved prescribing information.~   "
73236|NCT02608346|"~     BRCA1 carriers who are at high risk of developing either a relapse and/or a new cancer growth~     will be included. These patients will be followed up during 30 months (2,5 years) with~     mutated TP53 mutation detection or during 42 months (3,5 years) with mutated TP53 mutation~     detection and circulating tumor cells detection (CTC) performed at each hospital visit (for~     technical reason only patients included at Institut Curie will be proposed to participate to~     the CTC substudy).~   "
73237|NCT02608333|"~     Intervention for autism spectrum disorder (ASD) in European French-speaking countries is~     often heterogeneous and poorly evaluated. Six French-speaking early intervention units for~     children with ASD following the Early Start Denver Model (ESDM) have been created since 2011~     with the common aim to evaluate effectiveness and cost-efficiency of the ESDM applied to the~     European French-speaking public health system. In those units, Children receive ESDM at~     minimum 12H per week by trained therapist. Therapist work in collaboration with parents (at~     home) and preschool or nursery.~      The first aim of the investigators study is to evaluate the effectiveness of ESDM~     intervention 12 hours per week during 2 years on the global development of children with ASD~     compared to the interventions commonly available in the community.~   "
73238|NCT02608320|"~     The purpose of this study is to evaluate the cumulative adhesion percentage for the test~     products and the reference products for both small and large patches.~   "
73239|NCT02608307|"~     In the setting of progressive or recurrent cancer, adolescent and young adult (AYA) patients,~     parents, and healthcare providers (HCP) are faced with multiple therapeutic options. Each~     treatment option has a unique risk/benefit ratio, resulting in a need to trade one desirable~     outcome for another or accept acute toxicities and treatment-related morbidity to increase~     the chance of survival. Adding to the complexity of this decision, stake holders characterize~     and value the risk/benefit ratios differently.~      This study seeks to learn what things are important to an adolescent or young adult with~     cancer, parents, and health care providers when making decisions about their treatment~     choices.~      PRIMARY OBJECTIVE: To quantify the relative importance of various factors believed to be~     important to adolescent and young adult patients with cancer, parents, and health care~     providers when choosing between treatment options in the hypothetical situation of~     progressive or refractory disease.~   "
73240|NCT02608294|"~     A pilot study was conducted, randomized, triple-blind study with allocation concealment.~     Which consisted in the application of KT in the anterior tibial muscle for 24 hours. 14~     subjects were randomized into 2 groups: intervention (with voltage) and sham (no pressure).~     Patient's gait footage was shot in the opening balance of phases, average balance and initial~     contact (first without the application of Kinesio Taping and after 24 hours of application)~     to be measured the angles of the ankle joints, knee and hip. Balance was assessed by the~     Biodex Balance System platform, configured to analyze the postural stability in level eight.~     The mean differences were assessed (MD) between groups and confidence interval (CI) of 95%.~   "
73241|NCT02608281|"~     Clinical study to evaluate diagnostic accuracy of low dose contrast enhanced dual energy~     mammography imaging (CEDEM+PRIME) in comparison with CE-MRI The primary objective of this~     clinical study is to assess diagnostic accuracy in breast cancer detection in Contrast~     Enhanced Dual Energy Mammography compared to CEMRI. Sensitivity and specificity will be~     compared for both modalities.~   "
73242|NCT02608268|"~     The purpose of this first-in-human study of MBG453 is to characterize the safety,~     tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of MBG453~     administered i.v. as a single agent or in combination with PDR001 in adult patients with~     advanced solid tumors~   "
73243|NCT02608255|"~     A Single-center prospective pilot study enrolling chest pain patients. CD 26 measurement will~     be performed and compared to troponin µs for early triage of these patients. This novel~     biomarker of myocardial ischemia (CD26) will be measured at the time of first medical contact~     (T0) and after 30 min simultaneously o troponin Ic.~      All patients aged over 18 years with chest pain which may be related to acute coronary~     syndrome requiring pre hospital medical contact through the Emergency Medical Service.~   "
73244|NCT02608242|"~     This is a Randomized, open-label, single-dose, 3-treatment, 3-period, 3-sequence crossover~     design.~   "
73245|NCT02608229|"~     In light of the central role of extracellular signal-regulated kinases (ERK) in pancreatic~     cancer, the investigators propose a phase I study to evaluate the ERK inhibitor BVD-523 at~     the recommended phase 2 dose in combination with nab-paclitaxel plus gemcitabine in patients~     with newly diagnosed metastatic pancreatic cancer. The primary endpoint will be maximum~     tolerated dose (MTD) or RP2D and safety. The secondary endpoints include safety, response~     rate, biochemical response, progression-free survival (PFS) and overall survival (OS). The~     exploratory endpoints include the assessing the impact of BVD-523 on the MEK/ERK pathway and~     other major pathway pertain to pancreatic cancer.~   "
73246|NCT02608216|"~     In this study positron emission tomography (PET/CT) imaging will be used to evaluate~     proliferative activity in sites of metastatic disease using the investigational radiotracer~     [18F]fluorothymidine (FLT).~   "
73247|NCT02608203|"~     Somatostatin receptors are overexpressed in GEP-NETs and can be visualized in vivo by~     radiolabeled somatostatin-analogs.~      During the last decades, conventional scintigraphy using 111In-DTPA-Octreotide (often named~     somatostatin receptor scintigraphy or SRS) was considered as the gold standard nuclear~     imaging technique in the evaluation of GEP-NETs. However, SRS may be suboptimal in this~     clinical setting because of the low intrinsic resolution of the technique and its selectivity~     for SST2 only. Its overall sensitivity is estimated to 60-70% (per lesion analysis), even~     when using the most recent SPECT-CT cameras. MRI have also a higher sensitivity than CT and~     SRS for the detection of liver metastases from GEP-NETs.~      In recent years, positron emission tomography (PET) imaging, a high resolution and sensitive~     technology, has gained an increasing role in oncology. It has also been evaluated in GEP-NETs~     with somatostatin agonists (SSTa) radiolabelled with Gallium-68 [68Ga], a positron emitter~     with very promising results. Its diagnostic sensitivity is clearly superior to SRS and many~     European centers have already replaced SRS by [68Ga]-PET-SSTa.~      Currently, three different [68Ga]-coupled peptides can be used in trials: DOTA-TOC, DOTA-TATE~     and DOTA-NOC with excellent affinities for SST2 (IC50: 2.5; 0.2 and 1.9 nM, respectively).~     Sensitivities of DOTA-TOC and DOTA-TATE PET/CT are quite similar.~      [68Ga]-DOTANOC which also binds to SST5 was recently found to detect significantly more~     lesions than the SST2-specific radiotracer [68Ga]-DOTATATE in patients with GEP-NETs but this~     requires further evaluation.~      It is therefore important to determine the interest of [68Ga]-DOTANOC combined with the~     standard diagnosis strategy in GEP-NETs and evaluate medicoeconomic impact of adding~     [68Ga]-DOTANOC in the work-up of patients.~      The investigators hypothesis is that [68Ga]-DOTANOC will modify the management in at least~     20% of patients in a more adapted way according to the 2012 ENETS guidelines in comparison to~     the decision based on the standard imaging work up (multiphasic WB CT, liver MRI and SRS).~      110 patients will be included prospectively in 5 different French experienced centers~     (Marseille, Bordeaux, Toulouse, Paris, Clermond-Ferrand).~   "
73248|NCT02608190|"~     Purpose: Stroke is a common cause of death and disability in Canada. Injury to the right~     hemisphere of the brain and the parietal cortex in particular, is common and results in a~     disorder known as 'neglect' in 40% to 95% of patients. These patients fail to attend to or~     respond to events occurring in left space; the disorder is devastating for the patient and~     their caregivers with the patient becoming dependent on assistance for most activities of~     daily life (ADLs).~      The project will implement two visual working memory (VWM) training programs to explore the~     influence of VWM training on neglect symptoms as well as activities of daily life.~      Hypothesis: It is hypothesised that SWM training protocols will lead to improvements of~     neglect symptoms as well as improvement in ADLs.~      The project will develop a novel rehabilitation strategy for treating the neglect syndrome.~      Evidence from research in healthy participants employing video games to improve cognition~     along with research using working memory training protocols showing a broad range of benefits~     accruing to both trained and untrained tasks, suggests that the investigators approach has~     great potential to improve the core deficits of the neglect syndrome. Thus, WM training~     represents a promising avenue for rehabilitating neglect patients who demonstrate core~     deficits in both spatial attention and VWM to be highly interrelated functions.~   "
73249|NCT02608177|"~     The goal of this study is to test whether a dipeptidyl peptidase-4 inhibitor, compared with a~     sulfonylurea, improves time in normal blood glucose range and reduces blood glucose~     variability. Blood glucose is measured using a continuous glucose monitoring device.~   "
73250|NCT02608164|"~     The aim of the study is to compare the effectiveness of a vitamin D3 oral spray solution with~     capsules at raising vitamin D status over winter.~      This randomised crossover trial will aim to recruit a total of 22 healthy participants for a~     total of two 4-week interventions separated by a 10-week washout.~   "
73251|NCT02608151|"~     Premature birth deprives infants of sensory stimulation. Tactile stimulation such as massage~     pressure with kinesthetic movement significantly increases the weight, bone density and~     shorten the duration of stay of premature babies who benefits.~      Studies using vegetable oils show an increase in the effect on weight gain by cutaneous~     absorption. The mechanism is probably vagal (stimulation of baroreceptors and skin~     mechanoreceptors) since it is found in children stimulated an increase in the vagal activity,~     acceleration of gastric emptying and an increase in the secretion of insulin and IGF1.~      Few studies have evaluated the effects of massage on the medium-term neurological development~     in preterm infants and the effect of the essential oils in the effectiveness of touching the~     short and medium term massage.~      The aim of the investigators study is to evaluate the neurological development in the short~     and medium term in premature newborns and biological effects of massage with essential use of~     vegetable oil.~      Methodology and possible collaborations This is a monocentric, randomized, controlled, in a~     neonatal intensive care unit. It concerns 60 children born between 26 and 30 weeks of~     amenorrhea. Each child receives massage randomized with or without oil ISIO 4. The treatment~     is administered 10 minutes twice a day for 10 consecutive days watching for signs of~     intolerance. The quality of the spontaneous motility between 12 and 20 weeks of age corrected~     is used as the first neurological assessment criterion.~      The questionnaire (ASQ) Bricker and Squires (translated into French by Martha Bonin et al.)~     is used to 6, 12, 24 months corrected age and completed by the parents as a second~     neurological endpoint.~      A lipid chromatography is performed at the beginning and at the end of the massage time and~     at the deliverance from NICU for comparing the profile of children's fatty acids.~      Expected results Show that there is an improvement in the neurological development in~     children who received massage with vegetable oil ISIO 4. Show that there is a skin absorption~     of essential fatty acids that can substitute for a known major deficiency in premature even~     in infants fed breast milk.~   "
73252|NCT02608138|"~     It is well known that insufficient iodine intakes impairs the production of thyroid hormones,~     essential for cognitive development and healthy growth.~      Although the World Health Organization (WHO) promotes public health measures for an adequate~     iodine consumption, it is estimated that one in three school age children remain iodine~     deficient worldwide. Whereas there is no mandatory iodisation programs in Portugal, young~     infants are among the most vulnerable to iodine deficiency due to their special requirements.~      Therefore, the present study aims to evaluate iodine status in school age Portuguese children~     (6-12y), compare iodine status in children, cognitive outcomes and thyroid health and monitor~     the use of iodised salt in school canteens exploring potential implications in children's~     iodine status.~   "
73253|NCT02608125|"~     This is a multi-center, open label, non-randomized Phase 1 study, to be conducted in two~     parts, Part A, and Part B. Part A is the dose escalation phase for evaluating the safety and~     tolerability profile of PRN1371, a FGFR 1-4 Kinase inhibitor. Part B is the Cohort Expansion~     phase to further evaluate safety and tolerability, preliminary activity, PK, and PD in~     patients with FGFR genetic alterations.~   "
73254|NCT02608112|"~     This multicenter, prospective, non-interventional study is designed to obtain an accurate~     estimation of the drug retention rate of Tocilizumab (TCZ) Subcutaneously (SC) under~     real-world conditions in participants with moderate to severe rheumatoid arthritis (RA).~   "
73255|NCT02608099|"~     The purpose of the prospective, randomized cohort in this study is to assess the safety and~     efficacy of 2 apixaban treatment strategies (uninterrupted versus interrupted) in subjects~     planned to undergo catheter ablation for the treatment of non-valvular atrial fibrillation~     (NVAF).~      Simultaneously, a retrospective cohort of 300 warfarin-treated individuals, identified by~     chart review, who are matched to the prospective randomized subjects, will be identified. The~     purpose of the retrospective warfarin cohort is to compare the efficacy and safety of~     warfarin(the current clinical practice) to that of apixaban (uninterrupted, interrupted,~     combined uninterrupted and interrupted).~   "
73256|NCT02608086|"~     Psychological First Aid (PFA) is currently the most recommended early intervention for people~     affected by recent traumatic events, especially in the aftermath of natural disasters.~     Unfortunately, there is no evidence that PFA neither prevents Post-Traumatic Stress Disorder~     (PTSD) nor other post-traumatic disorders or symptoms of distress. This project aims to~     evaluate the efficacy and safety of Psychological First Aid for the prevention of PTSD and~     other post-traumatic disorders or symptoms.~   "
73257|NCT02608073|"~     This study will evaluate the efficacy, safety, tolerability, and effect on quality of life of~     oral capecitabine in combination with intravenous (IV) cisplatin in participants with~     metastatic nasopharyngeal cancer. Participants will receive up to 8 cycles of capecitabine~     treatment, and cisplatin will be administered on the first day of each cycle. The anticipated~     time on study treatment is up to 24 weeks, and the target sample size is 44 individuals.~   "
73258|NCT02608060|"~     This study will examine the efficacy, safety and effect on hemoglobin levels, of once weekly~     subcutaneous injections of epoetin beta (30,000 IU) in anemic participants with non-Hodgkin's~     lymphoma, chronic lymphocytic leukemia or multiple myeloma. The anticipated study duration is~     4 months, and the target sample size is 30 individuals.~   "
73259|NCT02608047|"~     The purpose of this study is to elucidate the local epidemic problem and epidemiological~     characters of dengue fever in Guangzhou, to establish diagnostic and treatment standard and~     clinical treatment system of severe cases to reduce the morbidity and mortality of dengue~     fever.~   "
73260|NCT02608034|"~     This is a two-part, Phase 1, open-label, multicenter, two-period, one-sequence study to~     investigate the effect of itraconazole and rifampin on the PK of vemurafenib following~     multiple 960 milligrams (mg) twice daily (BID) dosing in adult participants with unresectable~     Stage IIIC or Stage IV metastatic melanoma positive for the BRAF V600 mutation, or other~     malignant tumor types that harbor a V600-activating mutation of BRAF where the participant~     has no acceptable standard treatment options.~   "
73261|NCT02608021|"~     This protocol describes a study to validate Neurotrack's visual paired comparison task, aimed~     at early detection and monitoring of memory impairment. The investigators will determine~     whether the novel task developed by Neurotrack is associated with markers of brain pathology~     associated with very early Alzheimer's disease. The elderly subjects studied will be~     cognitively normal (CN) or have amnestic mild cognitive impairment (aMCI). For the current~     study, the primary brain pathology parameters will be derived from MRI scans. Data from this~     study will be correlated with data from a parallel study designed to validate a larger group~     of new cognitive tasks by correlating test performance with a broader array of biomarkers of~     Alzheimer's disease.~   "
73262|NCT02608008|"~     The purpose of this study is to collect data regarding the safety and efficacy of~     EchoNavigator System Release II during structural heart interventions in the clinical~     practice. Data of procedures with and without the use of EchoNavigator System Release II will~     be collected, analysed and evaluated.~   "
73263|NCT02607995|"~     Obesity occurs more frequently in subjects of a lower socioeconomic status and is associated~     with a lower income and unemployment. On the other hand, there is limited access of~     individuals with low socioeconomic status to conventional obesity treatments and bariatric~     surgery.~      In STEREOplus the investigators will ascertain unemployed adolescents with obesity and~     extreme obesity at five job centers in the Ruhr area. Unemployed obese youths and young~     adults (BMI ≥ 30kg/m2) between the ages of 14 and 24.9 years are eligible to participate.~     Participants will be asked to complete a series of questionnaires on their general health,~     psychosocial situation and wellbeing, and will be offered a thorough medical evaluation.~     Individuals who complete the baseline evaluations will be invited to participate in six group~     sessions of conventional obesity treatment over a three months period. After six months,~     participants will complete further questionnaires to evaluate the effects of the~     interventions on quality of life and psychosocial functioning. Weight status (BMI) will also~     be measured. Adolescents who attended at least five sessions and are interested in bariatric~     surgery will have access to a structured information and preparation program for bariatric~     surgery.~      The overall objective of STEREOplus is to generate data on the feasibility of the planned~     implementation of a treatment targeted to a high risk group with a low socioeconomic~     background in order to reduce treatment barriers.~   "
73264|NCT02607982|"~     This study aimed at assessing the efficiency and safety of concurrent chemoradiotherapy~     (CCRT) using paclitaxel (PTX) plus oxaliplatin (OHP) in unresectable locally advanced~     esophageal cancer patients.~   "
73265|NCT02607969|"~     30 babies with Deformational Plagiocephaly (DP) due to the congenital muscular torticollis~     will be the participants of the study.~      The subjects will randomly allocated into the two home program groups; first home program~     group was seen once every six weeks (SxW), second home program group was seen once a week~     (OW).~      Parents will educate about the same home program which consisted of positioning the neck and~     head, sleep in alternating head positions and in side-laying to increase head shape symmetry~     and place infants, when awake and under supervision, regularly in the prone position a day to~     stimulate normal motor development (tummy time), decreasing the time spent in car seat at~     supine position. Environmental settings also will be given to challenge the baby look through~     from the side no flattening to room, place colorful and sonorous toys or mirror on the~     opposite of the flattening side, and stimulate active rotation by communicating with baby~     from this side. Handling strategies, stretching and strengthening exercises will be given for~     CMT. The parents will be reinforme if necessary. Positioning strategies will spread~     throughout the day.Plagiocephaly severity assessment scale (PSS) which has 5 subgroups as~     following frontal asymmetry, occipital flattening, head tilt, fascial asymmetry, ear~     asymmetry will be used to evaluate severity of DP.~   "
73266|NCT02607956|"~     This study will evaluate the efficacy of a fixed dose combination (FDC) containing~     bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus dolutegravir (DTG) + a FDC~     containing emtricitabine/tenofovir alafenamide (F/TAF) in HIV-1 infected, antiretroviral~     treatment-naive adults at Week 48.~   "
73282|NCT02607748|"~     The purpose of this study is to evaluate whether 18F-NaF (sodium fluoride) Positron Emission~     Tomography (PET) scans can be used to identify ruptured and high-risk plaque as compared to~     non-invasive coronary Computed Tomography Angiography (CTA) scans and high-definition~     intravascular ultrasound (IVUS).~      In subsets of patients, 18F-NaF PET scans and CCTA will be repeated to assess scan-rescan~     reproducibility.~   "
73267|NCT02607943|"~     Hyperglycemia is common during acute ischemic stroke. However, the optimal strategy to~     control hyperglycemia during acute ischemic stroke has not been established. The object of~     this multicenter randomized controlled study is to determine the efficacy and safety of early~     initiation of subcutaneous once-daily insulin glargine, in comparison with regular insulin,~     based on a protocolized sliding scale regimen to achieve proper sugar control in acute stroke~     patients with hyperglycemia admitted to the intensive care unit.~   "
73268|NCT02607930|"~     The study will evaluate the efficacy of a fixed dose combination (FDC) containing~     bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus a FDC containing~     abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) in HIV-1 infected, antiretroviral treatment~     naive-adults.~   "
73269|NCT02607917|"~     This research will test the effect of mass media or mass media plus a clinic based education~     program will improve appropriate aspirin use for cardiovascular disease prevention. It is a~     group randomized design of 24 geographic areas in Minnesota with adjacent states serving as~     controls.~   "
73270|NCT02607904|"~     This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The~     open-label extension phase only will be described in this record. All participants will~     receive the same dose of GWP42003-P. However, investigators may subsequently decrease or~     increase the participant's dose until the optimal dose is found.~   "
73271|NCT02607891|"~     This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The~     blinded phase only will be described in this record. Participants will be randomized in a 4:1~     ratio to receive GWP42003-P or matching placebo. The hypothesis is that levels of stiripentol~     (STP) or valproate (VPA) may be altered (increased or decreased) as a result of using~     GWP42003-P.~   "
73272|NCT02607878|"~     Background: Sedation and therapeutic hypothermia (TH) delay neurological responses and might~     reduce the accuracy of clinical examination to predict outcome after cardiac arrest (CA).~     Electroencephalography (EEG) and somato-sensory evoked potentials (SSEP) might significantly~     improve prognostication of post-CA coma, however, EEG and SSEP are not always available and~     require specific expertise for their interpretation. Automated video pupillometry is a novel~     electronic device that contains an infrared light camera which enables to measure~     quantitatively the percentage of pupillary reaction to a calibrated light stimulation. In a~     recent study of a cohort of comatose CA survivors (n=50 patients) it was found that~     quantitative PLR was more accurate than standard PLR (manual pen light) in predicting 3-month~     outcome, irrespective of temperature and sedation, and had comparable prognostic accuracy~     than electrophysiological exams, including electroencephalography (EEG) and somato-sensory~     evoked potentials (SSEP).~      Aim of the study: In light of these promising results, the investigators would like to~     confirm the prognostic value of quantitative PLR in a large multicenter cohort of comatose~     post-CA patients.~      Design of the study: Prospective, multicenter, observational outcome trial.~   "
73273|NCT02607865|"~     This trial is conducted globally. The aim of the trial is to investigate efficacy and~     long-term safety of oral semaglutide versus sitagliptin in subjects with type 2 diabetes.~   "
73274|NCT02607852|"~     The primary objective of the overall study is to determine the feasibility and usefulness of~     a feedback system that delivers BOQ results to physicians in real time during outpatient~     encounters using iPads.~   "
73275|NCT02607839|"~     The purpose of study is to examine whether raised blood glucose enhances lipid particle~     production independent of effects on gastric emptying and pancreatic/ gastrointestinal~     hormone production.~   "
73276|NCT02607826|"~     Recent pre-clinical data provide strong evidence that short-term starvation before the~     administration of cytostatic drugs for the chemotherapy of solid tumors leads to~     significantly higher efficacy and lower toxicity levels. However, these findings have so far~     not been validated in patients. The aim of this trial is to provide first clinical evidence~     regarding the impact of pre-chemotherapeutic short-term starvation on response to therapy~     (primary endpoint). Additionally, progression-free survival, adverse events, and overall~     survival will be monitored (secondary endpoints). In perspective, short-term starvation~     before chemotherapy could represent a simple and secure way to improve both efficacy and~     tolerance of chemotherapies at low cost.~   "
73277|NCT02607813|"~     A Phase I Study of LXH254 in Patients With Advanced Solid Tumors That Harbor MAPK Pathway~     Alterations.~   "
73278|NCT02607800|"~     The primary objectives of this study are to compare the efficacy, safety, and tolerability of~     treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination (FDC)~     for 8 weeks with that of SOF/VEL FDC for 12 weeks in direct-acting antiviral-naive~     participants with chronic hepatitis C virus (HCV) infection.~   "
73279|NCT02607787|"~     The aim of this study is to assess the feasibility and effectiveness of a home-based walking~     and strengthening intervention on physiological, biochemical and psychological outcomes in~     colo-rectal cancer survivors.~      The intervention consists of a 12-week home-based walking and strengthening programme for~     colo-rectal cancer survivors post any anti-cancer treatment. It aims to gradually increase~     participants physical activity levels so that they start achieving the recommended levels of~     at least 150 minutes moderate intensity aerobic activity per week and strengthening exercise~     for all major muscle groups at least twice per week.~      As well as usual care, the intervention group will receive weekly telephone calls and a~     behaviour change interview at baseline. Participants will be recruited from the Cancer Centre~     at the Belfast City Hospital. Assessments will be taken at baseline (0 weeks), post~     intervention (12 weeks) and also at a 3-month follow-up (24 weeks). The control group will~     receive the same assessments at the same time-points however they will continue to receive~     usual care with the intervention information (including pedometer, exercise booklet, diary~     and behavioural change interview) being given at the 3-month follow-up appointment.~   "
73280|NCT02607774|"~     To determine whether secukinumab can alter the activity of cytochrome P450 (CYP) 3A4 using~     midazolam as probe substrate in patients with moderate-to-severe plaque psoriasis.~   "
73281|NCT02607761|"~     Recent evidence showed that undergraduate students have inappropriate knowledge about~     reproductive health and infertility.~      The investigators' aim was to assess the effectiveness of a brief intervention (video) in~     increasing the knowledge regarding fertility issues, fertility risk factors and infertility~     definition.~   "
73284|NCT02607722|"~     This is a non-interventional study based on new data collection to gather real-world~     information (i.e., data under routine medical practice) on safety and effectiveness of the~     Ofev® Capsules treatment.~      The study will consist of a baseline visit and follow-up visits at Week 4, 13, 26, 39, 52,~     65, 78, 91 and 104 for patients who have newly initiated Ofev® Capsules. The patients will be~     followed up until discontinuation of Ofev® Capsules treatment.~      As this is an observational study, no specific treatment is mandated or withheld from the~     patients. The choice of maintenance treatment for IPF must be according to regular medical~     practice and at the discretion of the physician (i.e., no randomised assignment of patient to~     treatment is performed).~      All patients administrated Ofev® Capsules after the launch at the sites contracted with the~     sponsor will be registered. The Case Report Forms (CRFs) of 1000 patients will be collected.~     However the patient registration continues until the approval condition has been removed.~      Patients participating in the subsequent follow-up will undergo regular observations. These~     observations should be reported after approximately Week 4, 13, 26, 39, 52, 65, 78, 91 and~     104 since the initiation of Ofev® Capsules as long as they continue to receive the treatment.~     Patients will not be followed any longer once they are reported to have discontinued the~     Ofev® Capsules treatment.~   "
73285|NCT02607709|"~     Two out of three tumours in the upper urinary tract are located in the renal pelvis.~     Muscle-invasive urothelial carcinoma is probably more common among tumours in the upper~     urinary tract compared to tumours in the urinary bladder. Thus, muscle-invasive tumours~     represent approximately 45 % of renal pelvic tumours compared to 25 % of tumours within the~     urinary bladder. As in the bladder, lymph node metastases are rare in non-muscle invasive~     disease. Information regarding indications, extent and possible curative potential is~     currently lacking for lymphadenectomy in conjunction with nephroureterectomy for urothelial~     carcinoma in the upper urinary tract (UUTUC). There are, however, retrospective series with~     survival data for patients with lymph node metastasis that report long term survival after~     surgery as monotherapy [4] with similar survival proportions as in bladder cancer with lymph~     node metastases after radical cystectomy. A retrospective study from Tokyo was expanded to~     the only available prospective study, where 68 patients with UUTUC were submitted to~     template-based lymphadenectomy. Another retrospective study by the same Japanese group,~     showed that 5-year cancer-specific and recurrence-free survival was significantly higher in~     the complete lymphadenectomy group than in the incomplete lymphadenectomy or without~     lymphadenectomy groups. Tanaka N et al. reported recurrence rate after nephroureterectomy~     without lymphadenectomy at 1 and 3 years were 18.9 and 29.8 %, respectively.~   "
73286|NCT02607696|"~     This is a Phase I, open-label, randomized trial to evaluate the single-dose pharmacokinetics~     of Zolpidem orodispersible tablet at two different dosages (1.75 mg and 3.50 mg). Sample size~     is 48 participants, male or female, aged above 18 years-old.~      Primary objective is to evaluate pharmacokinetics of Zolpidem orodispersible tablet at two~     different dosages (1.75 mg and 3.50 mg), and secondary objective is to evaluate safety and~     tolerability of the investigational product.~      Participants will be admitted for a period of 36 hours, when investigational product will be~     administered, and blood samples, at pre-determined time periods, will be collected for~     pharmacokinetics.~      Primary endpoint is to obtain pharmacokinetics parameters. Additionally, safety will be~     assessed by adverse events occurrence and laboratory exams evaluation.~   "
73287|NCT02607683|"~     This randomized, placebo-controlled, double-masked, Phase 2b/Phase 3 study will assess the~     efficacy of two different concentrations of XAF5 Ointment for reduction of lower lid~     steatoblepharon (undereye bags).~   "
73288|NCT02607670|"~     This is a Phase 2, randomized, double-blind, placebo-controlled study of TAT4 Gel for the~     reduction of moderate to severe nasolabial folds.~   "
73289|NCT02607657|"~     This is a Phase I, open-label, randomized, parallel trial to evaluate the pharmacokinetics of~     Eplerenone tablet at different dosages (25 mg once daily, 50 mg once daily, 100 mg (2 tablets~     of 50 mg) once daily and 50 mg twice daily). Sample size is 96 participants (24 per treatment~     group), male or female, aged between 18 and 50 years-old.~      Primary objective is to evaluate pharmacokinetics of Eplerenone tablet at different dosages,~     and secondary objective is to evaluate safety and tolerability of the investigational~     product.~      Study overall duration is approximately 12 weeks, including enrollment and follow-up visits.~     Participants will be admitted for a period of 36 hours, when investigational product will be~     administered, and blood samples, at pre-determined time periods, will be collected for~     pharmacokinetics.~      Primary endpoint is to obtain pharmacokinetics parameters. Additionally, safety will be~     assessed by adverse events occurrence and laboratory exams evaluation.~   "
73290|NCT02607644|"~     Introduction: The laryngeal mask airway (LMA) is used as the primary airway by paramedics in~     Singapore Civil Defense Force's Emergency Ambulance Service (SCDF's EAS) in the management of~     out-of-hospital cardiac arrest, because endotracheal intubation requires skilled and~     experienced personnel, and local paramedics are not trained to this level of skill and~     competency. However, self-reported insertion success rates by paramedics in the field are~     currently only about 50-87%. Devices like the laryngeal tube have been shown to have higher~     placement success rates and fewer complications.~      Aim: Investigators aim to evaluate the efficacy and safety of a new device, the Laryngeal~     Tube (LT), compared to the LMA. They hypothesize that the LT is superior to the LMA in terms~     of placement success rates by paramedics in SCDF's EAS, and is associated with fewer adverse~     events.~      Methodology: Investigators propose to conduct a prospective, longitudinal multi-centre~     randomized trial comparing LMA and LT in patients with cardiac arrest (medical or traumatic)~     managed by SCDF EAS. The trial will recruit 875 eligible patients presenting to SCDF~     irrespective of destination hospital over a period of 1 year to detect an expected 15%~     difference in placement success rate. Currently the LMA is used as standard of care by SCDF's~     EAS in patients with cardiac arrest.~      Results: Besides the primary outcome, the secondary outcomes of dislodgment rates, time to~     placement, number of attempts and adverse events will be analyzed and will be useful in~     guiding future SCDF cardiac arrest protocols.~   "
73291|NCT02607631|"~     This is a Phase II single center, open-label, single arm study in patients with advanced~     thymic epithelial tumors after failure of cisplatin-based combination chemotherapy. Patients~     will be treated with Pembrolizumab 200 mg every 3 weeks.~   "
73292|NCT02607618|"~     This is a multicenter, randomized, double-blind study of the efficacy and safety of iclaprim~     compared to vancomycin for the treatment of skin and skin structure infections.~   "
73295|NCT02607579|"~     The purpose of this prospective study is to examine the effect of two local anesthetics used~     in adductor canal blocks, with relation to pain, analgesic consumption, mobility, and pain~     related interference with activities and hospital length of stay. The two agents are~     bupivacaine and ropivacaine. The purpose of this trial is to examine the effect of these~     drugs being used in adductor canal blocks for pain relief, analgesic consumption, mobility,~     and pain related interference with activities and hospital length of stay.~   "
73296|NCT02607566|"~     This study will examine the feasibility and acceptability of a twice weekly yoga program for~     adults with type 2 diabetes. Changes in perceived stress, salivary cortisol, and HbA1c will~     also be examined.~   "
73297|NCT02607553|"~     An open-label, single-arm, single-center Phase II study to evaluate the safety and activity~     of G-202 in patients with clear cell renal cell carcinoma that expresses PSMA~   "
73298|NCT02607540|"~     A two-arm Phase III trial was started in Oct. 2014. Definitive chemoradiotherapy with~     cisplatin plus 5-fluorouracil is the standard in Western countries in esophagus cancer. But~     in China because of its toxic reaction, most of patients stop the halfway.~      The purpose of this study is to confirm the difference of 2 and 4 cycles of cisplatin plus~     5-fluorouracil in the definitive chemoradiotherapy for esophagus squamous cell carcinoma. A~     total of 210 patients will be accrued from China within 2 years. The primary endpoint is~     overall survival and the secondary endpoints include progression-free survival, response~     rate, pathologic complete response rate and adverse events.~   "
73299|NCT02607527|"~     Multi center evaluation of the Millipede IRIS for treatment of clinically significant mitral~     regurgitation in subjects determined appropriate for mitral valve surgery.~   "
73300|NCT02607514|"~     Study is a randomized controlled trial to assess the feasibility, acceptability, efficacy,~     and mechanisms of action of hyperthermic yoga versus a waitlist control for 80 medically~     healthy adults with mild to moderate depressive symptoms. The primary aim is to test the~     acceptability and feasibility of hyperthermic yoga as a treatment for depression. The~     secondary aim is to examine the effect size/efficacy of hyperthermic yoga for depressive~     symptoms. The tertiary aim is to explore physiological and psychological mechanisms of~     action.~   "
73301|NCT02607501|"~     An open label, prospective, multicentre, single-arm, post marketing study evaluating the~     safety, technical feasibility, and efficacy of the eCLIPs™ Family of Products for the~     treatment of bifurcation intracranial aneurysms.~   "
73302|NCT02607488|"~     Increasing rates of obesity over the last few decades have led to growing demand for~     bariatric surgery, which may resulted in decreased comorbidities and improved patient~     outcomes. Laparoscopic bariatric surgery has several clinical benefits in terms of improved~     quality of analgesia, reduced pulmonary complications, enhanced recovery of bowel function,~     less immune suppression, and shortened duration of hospital stay than open laparotomies.~      Some investigators reported delayed return of bowel function for approximately two days after~     laparoscopic bariatric surgery, despite it occurred one day earlier than after open~     laparotomy. This potentially can lengthen the duration of hospital stay after bariatric~     procedures. With the impeding cost of health care in the developing countries, safely~     reducing length of stay is essential.~      Other investigators reported early return of bowel movements during the first postoperative~     day in 65% of patients undergoing laparoscopic gastric bypass surgery due to reduced morphine~     use with implementation of a multimodal analgesia strategy including ketorolac, and~     propoxyphene hydrochloride/acetaminophen.~      Lidocaine was investigated in several studies for its use in multi-modal management~     strategies to reduce postoperative pain and opioid use and enhance recovery. A recent~     Cochrane review including 45 trials demonstrated that systemic administration of lidocaine~     was associated with reduced pain scores at most of 'early time points' in patients undergoing~     laparoscopic abdominal surgery (MD -1.14, 95% CI -1.51 to -0.78; low-quality evidence),~     shorter times to first flatus (MD -5.49 hours, 95% CI -7.97 to -3.00; low-quality evidence)~     and first bowel movement (MD -6.12 hours, 95% CI -7.36 to -4.89; low-quality evidence), and~     less risk of paralytic ileus (risk ratio (RR) 0.38, 95% CI 0.15 to 0.99; low-quality~     evidence). However, no evidence of effect was found for lidocaine on shortening the time to~     first defecation. This low-quality evidence may be related to the heterogeneity between the~     studies in respect to the optimal dose, timing and duration of the administration of~     intravenous lidocaine.~   "
73303|NCT02607475|"~     Robotic telesonography, in which an expert remotely performs sonography in real time, has~     recently emerged as an opportunity to perform sonography at remote centres. Using a robotic~     system and an assistant with limited training at the remote site, an expert can manipulate an~     ultrasound probe and generate images in real-time via an Internet connection. This study aims~     to demonstrate the feasibility of robotic telesonography for obstetric and adult and~     pediatric abdominal imaging in a centre with established sonography services which will be~     used as a comparator to robotic telesonography.~   "
73304|NCT02607462|"~     Study purpose is to evaluate perioperative usefulness of Platelet-rich Plasma (PRP) in total~     hip arthroplasty (THA) surgery. The study is designed as a randomized double blinded study~     using saline as placebo. The measurement outcomes includes objective variables (MRI,~     dynamometer) as well as subjective measurements (Oxford Hip Score, Harris Hip Score).~      Patients are assigned to two different groups, according to a randomization list. PRP~     (approximately 9ml from which 1ml is delivered to in-house laboratory for the measurement of~     platelet count) is obtained from venous blood and applied to m. gluteus medius during the~     closure of modified lateral approach (Hardinge).~      Study participants are evaluated preoperatively by trained physiotherapist. After surgery,~     participants undergo clinical evaluation and imaged (MRI) at 3 and 12 months post-operative.~     In the same time points, strength, Harris Hip Score and Oxford Hip Score. At the end of the~     study, the nature of the injected substance is revealed to the patients.~   "
73305|NCT02607449|"~     Drug-resistant tuberculosis is becoming a major problem for the whole humanity, and~     development of new Anti-TB drugs is of great importance. Since Kazakhstan is a country with~     the high burden of tuberculosis, The Government of The Republic of Kazakhstan has founded~     initiative on the development of new Anti-TB drug to treat drug-resistant forms of this~     infectious disease. JSC Scientific Center for Anti-infectious Drugs has developed original~     drug FS-1 for the treatment of multidrug resistant tuberculosis (MDR-TB).~   "
73306|NCT02607436|"~     This is a prospective interventional study to assess the effect of sarpogrelate compared with~     aspirin in Korean type 2 diabetic patients with atherosclerosis.~   "
73307|NCT02607423|"~     This phase II trial studies how well fludeoxyglucose F-18 (18F-FDG) positron emission~     tomography (PET)/computed tomography (CT) works in predicting response to chemotherapy in~     patients with stage IIIA non-small cell lung cancer that can be removed by surgery~     (resectable). Performing diagnostic procedures, such as fludeoxyglucose F-18 PET/CT, after~     one course of chemotherapy may help doctors predict a patient's response to treatment earlier~     and help plan the best treatment.~   "
73309|NCT02607397|"~     The cost of particle therapy (PT) are considerably higher than conventional radiotherapy (RT)~     with photons. Considering potential dosimetric advantages of PT, it is necessary to determine~     if PT are more cost-effective than photons per indication regarding quality of life,~     survival, and progression free survival. Given the lack of evidence for the benefit of~     particle therapy in relevant cases, investigators proposed an in silico trial to investigate~     to what extend proton therapy decrease the amount of irradiated normal tissue and,~     consequently, the risk of side effects in the surrounding normal tissue as well as the risk~     of secondary tumors. Given validated dose-response curves and/or NTCP models, a 10% lower~     mean dose of proton therapy on normal tissue compared to photon therapy should result in at~     least a 20% lower risk of side effects.~   "
73310|NCT02607384|"~     The Baltimore Reading and Eye Disease Study (BREDS) is a two year study to determine the~     prevalence of vision problems in an early school age population with reading difficulty.~     Comprehensive vision and reading tests will be administered to 400 students at participating~     schools in the Baltimore City Public School system.~      A secondary goal is to examine the impact of vision treatment on reading performance.~     Children with refractive error or convergence insufficiency will be provided treatment free~     of charge. The investigators will evaluate the impact that the treatment has on vision~     function and reading performance.~   "
73311|NCT02607371|"~     The main research question of this patient survey is to assess AF (Atrial Fibrillation)~     patients' preferences associated with different attributes which describe the different~     available anticoagulation treatment options (Vitamin K Antagonists [VKA] or New Oral~     Anticoagulants [NOACs] and, in case of NOACs, Apixaban, Dabigatran, Edoxaban or Rivaroxaban).~      VKAs (Marcoumar®, Sintrom ®) will be grouped together and compared to Rivaroxaban.~   "
73312|NCT02607358|"~     Determination of frequency of Clopidigrel- and Acetacylicacid-non-responders (HOTPR) in acute~     ischemic stroke patients.~   "
73313|NCT02607345|"~     Objective: to compare blood glucose and insulin responses after consumption of 100ml water,~     sweetened with 25gr Zusto® and 100ml water sweetened with 25gr Glucomedics® (standard drink)~   "
73314|NCT02607332|"~     With discovery of KIT mutations and the advent of KIT tyrosine kinase inhibitor imatinib~     (GlivecTM, Novartis), there has been substantial improvement in overall survival in patients~     with advanced and/or metastatic gastrointestinal tumors (GIST). Recently, sunitinib~     (SuteneTM, Pfizer) showed activity as second-line therapy in GIST patients after failure with~     imatinib. However, virtually all patients will eventually progress or become intolerable~     after the first-line imatinib and the second-line sunitinib.~   "
73315|NCT02607319|"~     The objective of this study is to determine the effect of Bemiparin, a low molecular weight~     heparin, on implantation rate in women with unexplained recurrent implantation failure~     undergoing IVF/ICSI treatment.~   "
73316|NCT02607306|"~     This trial is conducted in Asia. The aim of this trial is to compare the efficacy and safety~     of insulin degludec/liraglutide, insulin degludec and liraglutide in Japanese subjects with~     type 2 diabetes mellitus.~   "
73317|NCT02607293|"~     This is a Phase IV, prospective, observational, single arm, multicenter trial to identify the~     population at high risk of overstimulation associated with signs and symptoms of PCOS and~     examines the utility of 12.5 international units (IU) increment of Gonal-f® new pen for~     individualized controlled ovarian stimulation (iCOS).~   "
73318|NCT02607280|"~     Investigate the safety and efficacy of DS-5565 in Japanese subjects with Diabetic Peripheral~     Neuropathic Pain (DPNP) with renal impairment or Post-Herpetic Neuralgia (PHN) with renal~     impairment.~   "
73319|NCT02607267|"~     The Edmonton Obesity Staging System (EOSS) is a more comprehensive measure of obesity-related~     diseases and predictor of mortality than BMI or waist circumference. The aim of this study is~     to determine whether the EOSS is also important in predicting post - operative outcome and~     30-day mortality after metabolic surgery.~   "
73320|NCT02607254|"~     The purpose of this study is to assess safety and efficacy of treatment with pregabalin in~     patients with idiopathic small fiber neuropathy proven by skin biopsy.This is an enriched~     enrollment randomized withdrawal study that comprises 4 phases: a screening and selection~     phase, a washout period from previous pain medication for enriched enrollment, an 8 week~     single blind pregabalin treatment phase; and a 4 week randomized withdrawal phase.~   "
73321|NCT02607241|"~     This prospective randomized clinical trial aims to compare two different metal-free~     strategies for elective percutaneous coronary revascularization: the FFR-guided DCB-only PCI~     (drug-coated balloon: SeQuent Please™, B Braun Melsungen GmBH) vs. OCT-guided BRS~     implantation (bioresorbable scaffold: Absorb™, Abbott Vascular).~   "
73322|NCT02607228|"~     This study consists of two phases: Dose Escalation (Phase 1b) and Dose Expansion (Phase 2)~      The Dose Escalation phase will evaluate the safety and tolerability of GS-5829 as a single~     agent and in combination with enzalutamide, as well as determine the maximum tolerated dose~     (MTD) of GS-5829 as a single agent and in combination with enzalutamide in participants with~     metastatic castrate-resistant prostate cancer (mCRPC).~      The Dose Expansion phase will evaluate the following:~        -  In group 1, the efficacy of GS-5829 as a single agent in participants with mCRPC who~          have progressed while receiving enzalutamide (may have also received abiraterone)~        -  In group 2, the efficacy of GS-5829 combined with enzalutamide in participants with~          mCRPC who have progressed while receiving treatment with abiraterone (may not have~          previously received enzalutamide)~        -  In group 3, the efficacy of GS-5829 combined with enzalutamide in participants with~          mCRPC who have had Prostate Specific Antigen (PSA) progression, but not radiographic~          progression, while receiving treatment with enzalutamide (participants may have also~          previously received abiraterone)~   "
73323|NCT02607215|"~     Platinum Retreated in Patients with Platinum Sensitive mTNBC~   "
73324|NCT02607202|"~     Agnostos Trial is a multicentric phase 2 randomized trial with a 'pick-the-winner design' in~     chemonaive patients with cancer of unknown primary. It will assess the efficacy of the two~     best active single agent - carboplatin or gemcitabine - added to an innovative taxane back~     bone (nab-Paclitaxel). Agnostos trial is a part of a larger clinical and translational~     initiative to improve the outlook of patients with cancer of unknown primary through~     evaluation of novel chemotherapeutic regimens.~   "
73325|NCT02607176|"~     The objective of this study is to evaluate safety and efficacy of Heweizhixie Capsule in~     patients with diarrhea.~   "
73326|NCT02607163|"~     Acute kidney injury(AKI) is a common and severe complication after the cardiac surgery.~     Postoperative AKI increases the in-hospital stay, intensive care unit(ICU) stay and~     postoperative mortality. Aortic surgery is the most risky surgery that causes the~     postoperative AKI, and the incidence of AKI after aortic surgery is about 50%.~      The α1- and α2-adrenergic receptors in the kidney modulate vasoconstrictor and vasodilatory~     effects, respectively. Agents that attenuate renal vasoconstriction may have potential as~     renoprotective drugs because vasoconstriction most likely contributes to the pathophysiology~     of AKI. Clonidine, an α2-agonist, has been shown experimentally to inhibit renin release and~     cause a diuresis, and it has been evaluated in an experimental AKI model, confirming its~     potential as a renoprotective agent. Furthermore, it has been already reported that~     dexmedetomidine, α2-agonist, reduce the impairment of renal function after cardiac operation.~      The aim of this study is to examine the association between preoperative dexmedetomidine~     infusion and the incidence of postoperative acute kidney injury(AKI) in patients undergoing~     aortic surgery.~   "
73327|NCT02607150|"~     A prospective study designed to evaluate changes in tissue and cerebral oxygenation before~     and following administration of blood for patients undergoing spinal surgery.~      Red blood transfusions (autologous and allogeneic) are indicated to improve oxygen delivery~     to the tissues and hence tissue oxygenation. Despite the presumed efficacy, there are limited~     data to demonstrate changes in tissue oxygenation with the administration of blood.~     Furthermore, the administration of both autologous blood from cell saver and allogeneic blood~     can be associated with both acute and long-term deleterious physiologic effects which may~     impact the perioperative course. As such, data are needed to clearly delineate the benefits~     of transfusion during the perioperative period.~   "
73328|NCT02607137|"~     Holistic health is an integration and interaction of physical and psychosocial health.~     Positive psychology is a science of happiness, which focuses on positive emotions and~     personal strengths. It also is crucial component in family holistic health. Healthy diet can~     help to achieve energy balance and healthy weights. Physical activity is believed to~     contribute to physical and mental health, as well as social well-being. However, physical~     inactivity was found to be a local and worldwide issue and most Hong Kong people are having a~     sedentary lifestyle.~      In view of the health challenges locally and globally, the new phase of FAMILY project will~     focus to promote family holistic health with emphasize on the interaction and integration of~     physical and psychosocial health. The investigator will initiate and develop a series~     innovative training program with vigorous evaluation in order to evaluate the effectiveness~     of the programs. The investigator hypothesize that the training programs would promote the~     health awareness and the health of the participants~   "
73329|NCT02607124|"~     In this research study the investigators want to learn more about the effects, both good and~     bad, when the study drug Ribociclib is given after radiation therapy.~      The investigators are asking people to be in this research study that have been newly~     diagnosed with a high grade glioma, and the tumor has been screened for the Rb1 protein, and~     have recently finished radiation therapy. Patients with a DIPG or a Bi-thalamic high grade~     glioma do not need to have tumor tissue screened for the Rb1 protein but do need to have~     finished radiation therapy.~      Tumor cells grow and divide quickly. In normal cells, there are proteins called~     cyclin-dependent kinases (CDK 4 and 6) that control cell division. Another protein Rb1 also~     controls cell division and works to stop cells from dividing so they do not become cancer~     cells. But in cancer, the CDK 4 and 6 proteins are out of control making the cells divide and~     grow quickly. The study drug, ribociclib stops the CDK 4 and 6 proteins. When the CDK 4 and 6~     proteins are stopped, the normal Rb1 protein can now work to slow cell growth. For patients~     with HGG, to be in this study tumor tissue must have a normal Rb1 protein. The researchers~     think that if the study drug is given soon after radiation therapy, it may help improve the~     effect of the radiation in stopping the tumor from growing.~      The study drug, Ribociclib is considered investigational as it has not yet been approved by~     the United States Food and Drug Administration. The study drug has been tested in children~     and adults with cancer in prior research studies.~   "
73330|NCT02607111|"~     This study evaluates the optimal dosage and safety of Dalteparin when used as an~     anticoagulant for hemodialysis therapies.~   "
73331|NCT02607098|"~     The purpose of this study is to understand the experience of men and their partners when~     diagnosed with male-factor infertility while trying to achieve a pregnancy and the skills~     they use to adapt to this diagnosis.~   "
73332|NCT02607085|"~     This study evaluates the management of subjects with Standard of Care (SOC) when admitted to~     the Emergency Department (ED) with hyperkalemia (potassium value ≥ 5.5 mmol/L). Demographics~     and medical history data, including previous ED visits and/or hospital admissions for~     hyperkalemia and reason for current ED admission, will be recorded. Subjects who receive an~     intervention/treatment for hyperkalemia will have study-related potassium values determined~     at 30 minutes, 1, 2, and 4 hours after the start of treatment. Subjects who receive no~     intervention/treatment during the initial 4-hour period will have a study-related potassium~     value determined 4 hours after the baseline potassium measurement. Available data obtained as~     part of SOC management will include physical examinations, vital signs, fluid intake and~     urine output, ECGs, clinical laboratory data, and results of chest x-rays. Data regarding the~     subject's chief complaint upon admission to the ED, the possible cause of the subject's~     hyperkalemia, and admitting and discharge diagnosis will be recorded; the subject's overall~     discharge summary will also be collected.~   "
73358|NCT02606721|"~     The objective of this study is to correlate various diagnostic measurements taken during an~     escalating dose oral food challenge to the subject's response. This study will investigate~     whether non invasive objective biomarkers can indicate a positive response to an escalating~     dose OFC before a systemic reaction occurs.~   "
73359|NCT02606708|"~     The primary purpose of this study is to determine the feasibility and tolerability of a~     regimen of accelerated (hypofractionated) Intensity Modulated Radiation Therapy (AIMRT) to~     the whole breast as part of breast preservation. In addition, the investigators want to~     prospectively collect blood specimens to: assess TGF-β polymorphisms to identify potential~     carriers at higher risk for post-treatment fibrosis; generate a blood specimen repository for~     future studies of other relevant polymorphisms. The study investigators also want to~     prospectively follow each treated woman yearly to assess long-term radiation sequelae of the~     current regimen by using the LENT/SOMA scores.~   "
73333|NCT02607072|"~     Background: Evidence of high quality has suggested that acetylsalicylic acid (ASA)/aspirin~     effectively reduces colorectal adenoma incidence and recurrence rate, and several randomized~     controlled trials (RCTs) strongly indicate its potential to prevent colorectal cancer (CRC)~     initiation and progression and to decrease cancer-related mortality. However the role of~     aspirin supplied as an adjuvant agent in postsurgical CRC patients remains obscure, and a RCT~     is warranted for clarification.~      Aim: The APREMEC trial aims to investigate the potential preventative role of enteric-coated~     aspirin (100 mg and 200 mg daily) against postsurgical recurrence and metastasis among Asian~     CRC patients.~      Design: The investigators hypothesize that this large-scale multicenter randomized~     double-blind placebo-controlled trial will support that aspirin can reduce recurrence and~     metastasis and improve survival in postsurgical non-metastasized CRC patients. The primary~     endpoint of this trial is disease-free survival, and the secondary endpoints are 3-year and~     5-year overall survival, the interactive effects of lifestyle including smoking and alcohol~     ingestion, and adverse event rate. Eligible postoperative patients with non-metastasized CRC~     will be randomized in this trial to 100 mg aspirin, 200 mg aspirin or placebo until~     recurrence/metastasis, severe adverse event, death, or end of study, after standard adjuvant~     therapy. Individuals with peptic ulcer, bleeding tendency, or previous or ongoing treatment~     with aspirin or other anticoagulants will be excluded from this trial. Stratification factors~     are gender, study center, cancer site, and tumor stage. After randomization, patients will be~     followed up with evaluations at a 3-month interval while taking study drug.~      Discussion: This study aims at investigation of aspirin's role as an adjuvant agent in~     prevention of postsurgical CRC recurrence and metastasis. If results turn out to be positive,~     Asian and global CRC patients will be greatly benefited, due to the fact that aspirin is~     inexpensive, easily-accessible, and simply-administered, with well know and managed adverse~     events.~   "
73334|NCT02607059|"~     Epidemiologic and retrospective multicenter registry of all patients diagnosed with de novo~     or secondary acute myeloid leukemia (AML) in the PETHEMA Group institutions. This study is a~     non-interventional research regarding diagnosis and therapeutic approach~   "
73335|NCT02607046|"~     Peripheral artery disease (PAD) results in blockages of arteries (blood vessels) and~     decreased blood flow to the legs. This may cause difficulty or pain with walking or other~     activities that use leg muscles. Exercise may help improve blood flow in the legs and improve~     the ability to walk. This research project will be conducted patients with PAD that require~     revascularization. The goal is to examine the effects of 3 months of exercise rehabilitation~     and neuromuscular stimulation on leg blood flow, physical function, quality of life and~     general health.~   "
73336|NCT02607033|"~     This study is designed to examine the added benefits of weight loss to an exercise program in~     older obese Veterans with peripheral arterial disease. The investigators want to determine if~     weight loss in addition to exercise will 1) improve walking ability to a greater extent than~     exercise alone and 2) determine the underlying reasons why walking ability improves by~     measuring blood flow and the amount of muscle in the leg muscles.~   "
73337|NCT02607020|"~     Fatigue is the most chronic and disabling symptom in multiple sclerosis patients.~     Self-management physical exercise programs seem promising to allow patients to improve their~     fatigue and their deconditioning. However, the effectiveness of such programs has been poorly~     assessed until now. The objectives of the present study are to evaluate the relationships~     between fatigue and physical capacity among slightly affected MS patients, and to carry on a~     large trial to assess the effectiveness of a self-management exercise program in the same~     patients. Sixty-four patients will be included and will be asked, after an educational~     period, to perform at least three exercise sessions of more than 30 minutes each week, over a~     period of three months. Patients will be splitted in two groups : one group will perform~     endurance and resistance physical exercises, and the other one will perform relaxation~     exercises with the help of soothing music. A regular coaching will adapt the exercises and~     motivate the patients to continue the treatment. Assessors won't be informed of patients'~     treatment. Four evaluations will be done, and will notably assess muscle strength, endurance,~     fatigue and social participation.~   "
73338|NCT02607007|"~     This study investigates the effects of dairy breakfasts (2% cow's milk, 2% Greek yogurt,~     cheese) and a non-dairy breakfast (soy beverage) on satiety and post-meal blood glucose. Each~     participant will receive every treatment in this crossover design study.~   "
73339|NCT02606994|"~     The purpose of this study is to determine whether Oral Defense Toothpaste causes accelerated~     healing of chemotherapy-induced oral mucositis.~   "
73340|NCT02606981|"~     Municipal water networks within industrialized countries typically rely on centralized~     treatment to manage piped water quality. Optimal water quality at the tap, however, requires~     well-maintained piped distribution networks, and performs best when piped systems are fully~     pressurized. In low-income cities such as Dhaka, water distribution networks are inadequately~     maintained and typically supply intermittent service; as such, they are vulnerable to~     recontamination during negative pressure events. Among populations accessing these types of~     improved water sources in urban settings (e.g. shared taps), it is unknown if consistent~     treatment to provide chlorinated water at the point of collection would have a significant~     health benefit. Furthermore, almost all previous studies of water treatment interventions in~     low-income countries have been unblinded with self-reported diarrhea as the main outcome,~     casting doubt that reported impacts of water disinfection on diarrhea are not due entirely to~     social desirability bias. Stanford University in collaboration with icddr,b will conduct a~     randomized evaluation to assess the impact on access to automatically chlorinated water on~     water quality and child health.~   "
73341|NCT02606955|"~     Clinical methods are fundamental in probing the DW. They must be supported by strict BIA~     protocols. REST appears to be a (the) brilliant solution in solving the old problem of DW in~     HD patients~   "
73342|NCT02606942|"~     Comparing the physical and sonographic findings of dancers with Chondromalacia patella to~     non-dancers athletes.~   "
73343|NCT02606916|"~     This Prospective, single-arm Phase Ⅱ study is to determine the efficacy and safety of~     Once-daily Simultaneous Modulated Accelerated Radiotherapy combined with S-1/DDP for geratic~     esophageal squamous cell carcinoma patients.~   "
73344|NCT02606903|"~     To investigate and compare the pharmacokinetics, safety and tolerability of BI 695501~     administered subcutaneously via prefilled syringe or autoinjector~   "
73360|NCT02606695|"~     A comprehensive approach to the evaluation of alignment in spinal surgery patients - through~     preoperative planning, intraoperative assessment, and postoperative confirmation - has not~     been well-studied. This study aims to assess the value of such planning through clinical and~     radiographic outcomes.~   "
73361|NCT02606682|"~     The purpose of this study is to determine the safety, tolerability and blood levels of orally~     administered NPT200-11 in healthy subjects. In addition, the maximally tolerated dose will be~     determined.~   "
73345|NCT02606890|"~     The aim of this retrospective cohort study is to investigate the relationship between lesion~     pattern on Magnetic Resonance Imaging (MRI) and atrial fibrillation in patients with acute~     ischemic stroke. The investigators hypothesize that a pattern with lesions located in at~     least two of the main arterial territories of the brain (left or right internal carotid~     artery or posterior circulation territory) is associated with atrial fibrillation.~      The investigators will retrospectively analyze clinical data and imaging lesion pattern of~     1000 consecutive patients who were admitted to the Department of Neurology (Charite -~     Universitätsmedizin Berlin, Campus Benjamin Franklin) and diagnosed with acute ischemic~     stroke.~      Acute stroke patients of this cohort underwent 3-Tesla MRI with Diffusion-weighted Imaging~     (DWI) and Fluid-attenuated Inversion Recovery (FLAIR) sequences as well as standard 12-lead~     electrocardiography (ECG) on admission and cardiac monitoring with automated arrhythmia~     detection during stroke unit care lasting at least 24 hours.~      If DWI and FLAIR lesions are located in more than one of the main arterial territories,~     lesion pattern will be categorized as multiple lesion pattern.~      The investigators hypothesize that a multiple lesion pattern will be detected more frequently~     in acute stroke patients with atrial fibrillation than in patients without atrial~     fibrillation.~      The findings of this study might help to identify patients who could profit from extended~     diagnostic work-up in order to detect atrial fibrillation.~   "
73346|NCT02606877|"~     The primary objective of this study is to investigate the effect of steady state pirfenidone~     on the pharmacokinetics of nintedanib and its metabolites following oral administration of~     2403 mg/day pirfenidone and to investigate the effect of steady state nintedanib on the~     pharmacokinetics of pirfenidone at steady state following oral administration of 150 mg bid~     nintedanib. There will be two cohorts of patients; the first one will consist of patients not~     treated with pirfenidone or nintedanib, while the second one will consist of patients on~     pirfenidone treatment.~   "
73347|NCT02606864|"~     This study will evaluate the effect of food on the absorption of the drug as well as safety~     and tolerability of the novel 30 mg tablet (administered as 120 mg dose) in adults suffering~     from chronic Chagas' disease when administered after a high-fat / high-calorie test meal~     (American breakfast) compared to a fasting state. This study is required as part of the~     clinical development of an age appropriate pediatric oral dosage form for the treatment of~     Chagas' disease in endemic countries according to the recommendations provided by current~     international guidelines (EMA Guideline on Clinical Development of Medicinal Products, EMA~     Note for Guidance on Oral Dosage Forms).~   "
73348|NCT02606851|"~     China Survey of Proton Pump Inhibitor Empirical Treatment in Management of Outpatients with~     Gastroesophageal Reflux Disease~   "
73349|NCT02606838|"~     The purpose of this study was to determine if untrained subjects with diabetes could perform~     basic tasks with the Styx lancing device to obtain adequate blood volume from fingerstick and~     palm lancings for Blood Glucose Meter testing.~   "
73350|NCT02606825|"~     This is a retrospective study to analyze the therapeutic results and clinical evolution all~     patients diagnosed with AML and aged ≥ 60años or not candidates for chemotherapy intensive,~     treated according to the different schemes available, including supportive care or~     palliative.~   "
73351|NCT02606812|"~     The objective of the Project is to assess the effect of traditional food on the expression of~     micro-ribonucleic acid (miRNA), which regulate genes related to glucose metabolism. It will~     be a randomized experimental research. The research hypothesis is that consumption of~     traditional food will resolve biomarkers of glucose-related anomalies. Students of The~     Academic Division of Health Sciences (DACS for its initials in Spanish) will be invited to~     participate and they will be divided randomly in two groups. The experimental group will~     receive daily, five days per week, during three months, a lunch based on traditional~     Mesoamerican food emphasizing local produce. The experimental group will be provided an~     equivalent ratio of fast food from the school cafeterias. In both groups, at the start and~     end of the protocol, values of lipid, glucose, reactive protein C, alanine aminotransferase,~     and glycosylated hemoglobin profiles will be determined through spectrophotometric methods.~     The levels of expression of five miARN involved in regulating genes related to glucose~     metabolism (miR-320, miR-33a/b, miR-145, miR-335, and miR-124a) will be determined also by~     means of PCR amplification techniques. Statistical analyses will be based on two-way ANOVA,~     with a Dunnet's test procedure to find significance in measurements; significance will be set~     at p ≤ 0.05.~   "
73352|NCT02606799|"~     This study evaluates the effect of extracorporeal removal of inflammatory mediators on the~     systemic inflammation reaction of patients admitted to the intensive care unit following~     elective esophagectomy. Half of the participants will be treated with an adsorption device~     (CytoSorbents Adsorber), while the other half will be treated according to standard care.~     Significant reductions of interleukin-6 plasma concentration, SOFA score and catecholamine~     dosage in the intervention group are expected.~   "
73353|NCT02606786|"~     The purpose of this study is to examine the effectiveness of lumbopelvic stabilization~     exercises on women who have undergone Caesarian sections on: 1) disability using the Modified~     Oswestry Low Back Disability Index (OSW), 2) pain according to the Numeric Pain Rating Scale~     (NPRS), 3) percent change of muscle thickness of the deep abdominals using ultrasound~     imaging, and 4) perceived improvement using the Global Rating of Change (GROC).~   "
73354|NCT02606773|"~     The aim of this study is to evaluate the bioavailability of Novo C Plus vitamin C~     containing dietary supplement compared to licensed vitamin C medications. The novelty of this~     product is the liposomal formulation.~   "
73355|NCT02606760|"~     The purpose of this study is to confirm the clinical efficacy and the safety of P-3073 in~     patients affected by isolated psoriatic nail(s) and/or those with psoriatic nails and~     concomitant mild to moderate plaque psoriasis.~   "
73356|NCT02606747|"~     This study will evaluate the balance ability of DPN (diabetic peripheral neuropathy)patients,~     which will help us to understand the relationship between peripheral and central nervous~     system, in order to early diagnosis and prevent the fall in DPN patients.~   "
73357|NCT02606734|"~     The purpose of this study is to evaluate the usability characteristics of DyeVert™ during~     normal clinical use and to understand the amount of contrast media (CM) diverted from the~     subject and saved over a total angiographic procedure.~   "
73362|NCT02606669|"~     Background and Aims: The 5:2 diet, a form of intermittent energy restriction, has been~     popularized in Europe and USA. The rationale behind this approach is that two days of dieting~     is potentially more achievable, yet long enough to reduce overall weekly energy intake.~     However, this specific approach is lacking in evidence. Therefore, we are keen to investigate~     the effectiveness of this form of intermittent energy restriction compared with a control~     intervention (providing dietary and exercise advice only), in overweight, Chinese subjects,~     for an intervention period of 12 weeks.~      Design and Methods: This will be a randomized controlled trial, with 15 subjects in each arm,~     for an intervention period of 12 weeks. Subjects randomized to the treatment group will take~     three packets of a meal replacement product (Optifast®) per day during two consecutive~     fasting days, and take a healthy balanced diet that meet estimated energy requirements for~     the remaining five days. Subjects randomized to the control group will be given general diet~     advice and allowed to eat ad libitum throughout the study period. Measurements and laboratory~     tests will be done at baseline, 4 weeks and 12 weeks. Adherence to the dietary interventions~     will be assessed at 4 weeks and 12 weeks using 7-day food diaries.~      Significance: This will be the first study looking at an Asian population and will serve as a~     pilot towards a larger randomized trial. If this approach is found to be safe, effective and~     easier to adhere compared to the traditional continuous energy restriction, then it will be a~     very valuable option in the treatment of obesity, which has become an increasing problem~     globally including Singapore.~   "
73363|NCT02606643|"~     Once admitted, women who will have a transcervical balloon catheter inserted for induction~     will be approached for participation in this study. If they agree to be take part in this~     study (tape or no tape) they will be randomized into the study. After the balloon catheter is~     inserted, the balloon will then be filled with approximately 50-60 mL of normal saline, this~     is normal procedure.~      Study related: If randomized to No Taping the foley will be positioned comfortable and not~     placed to tension. For the Tension arm, tension will be placed on the balloon catheter,~     which will then be taped to the patient's inner thigh. The tension will be assessed and~     retaped as needed approximately every 30 minutes by the research and/or the nursing staff.~   "
73364|NCT02606630|"~     This open-label positron emission tomography (PET) study is designed to determine the effect~     of ABT-555 on translocator protein expression level in participants with relapsing forms of~     multiple sclerosis.~   "
73365|NCT02606617|"~     With the improvement of living level, the incidence rates of diabetes, obesity, and~     hypertension in China increased quickly, which are 11.6%, 7.1% and 18.8% respectively,~     according to the newly investigated data. The clustering of diabetes, obesity, hypertension~     and dyslipidemia increases the risk of cardiovascular events for patients. GLP-1 (glucagon~     like peptide-1) is a kind of incretin discovered in recent years. It was reported that beside~     its hypoglycemic and losing weight effects, activator of GLP-1 receptor could decrease blood~     pressure and improve lipid metabolism. Sleeve gastrectomy can improve the level of blood~     glucose and serum lipid of type 2 diabetic rats by ameliorate insulin level and insulin~     resistance, which may be related with the change of gastrointestinal hormones such as ghrelin~     and GLP-1. So, intervention of gastrointestinal tract and gastrointestinal hormone secretion~     may be a new therapy for glycolipids disorder and vascular complications. But, it is lack of~     evidence-based medicine proof on the relationship between prokinetic drug and glycolipids~     metabolism. So, the investigators designed a prospective, randomized, double-blinded, placebo~     control study, and try to evaluate the effects of prokinetic drug (Mosapride) on the blood~     glucose and serum lipid in type 2 diabetic patients.~   "
73366|NCT02606604|"~     This study will seek to determine the benefits that FES-LE cycling has over cycling alone on~     walking performance and quality of life in people with multiple sclerosis.~   "
73367|NCT02606591|"~     The goal of this research study is to learn about how brain activity, cognitive tests (tests~     of participant's brain function), and stress hormones are related to taking part in a health~     and wellness program in elementary-aged students.~   "
73368|NCT02606578|"~     Patients that are either scheduled to undergo or have undergone an achalasia procedure at the~     Mayo Clinic Rochester are asked to participate. The purpose of this study is to gather~     information and determine if one of these procedures is superior to the other.~   "
73369|NCT02606565|"~     Background: Nearly all the yearly 3.3 million neonatal deaths occur in low and middle income~     countries. Infections, including those affecting the umbilical cord (omphalitis) are a~     significant factor in approximately a third of these deaths. In fact, the odds of all-cause~     mortality are 46% higher among infants with umbilical cord infection than those without~     infection. Five large randomized controlled trials in Asia and Sub-Saharan Africa have~     examined the effect of multiple applications (for at least 7 days) of 4% chlorhexidine (CHX)~     on the umbilical cord on omphalitis and neonatal death. These studies show a consitent~     positive effect of multiple applications on omphalitis but not on neonatal mortality. Whereas~     there is mounting evidence for the effect of 7 day chlorhexidine application, there is no~     data from Africa and only one study from Asia that examines the effect of a single~     application of CHX as soon as possible after birth. In this single Asian study, CHX led to a~     reduction in the risk of mild-moderate omphalitis and neonatal death. It is important, in an~     African setting to explore the effect of a single application, which is programmatically much~     simpler to implement than daily application for 7 days. Therefore, the investigators' study~     will compare umbilical cord cleansing with a single application of 4% chlorhexidine at birth~     with dry cord care in both community and facility births on omphalitis and severe illness in~     the neonatal period.~      Methods: The chlorhexidine study is a community based, individually randomised controlled~     trial conducted on 4,760 mother-infant pairs in Uganda. The primary outcomes are severe~     illness and umbilical cord infection (omphalitis). Severe illness is defined as any illness~     associated with at least one of the following danger signs observed by study research~     assistants: inability to drink or breastfeed or (a history of) convulsions, lethargy or~     unconsciousness, vomiting of all feeds, and/or results in hospitalization and/or results in~     death.~      Discussion: This study will provide novel evidence, from a Sub-Saharan African setting of the~     effect of umbilical cord cleansing with a single application of 4% chlorhexidine at birth in~     both community and facility births.~   "
73370|NCT02606552|"~     Comparatively analyze the safety and validity of Amplazter Cardiac Plug (ACP) device-using~     percutaneous left atrial appendage closure, and the medical treatment with dabigatran plus~     aspirin or dabigatran plus clopidogrel after 3months triple therapy (Dabigatran plus DAPT~     (dual-antiplatelet therapy)) in patient with coronary artery disease treated with~     drug-eluting stent, accompanying atrial fibrillation.~      Total of 670 patients [left atrial appendage occlusion registry with 100 ACP/ 570~     anti-coagulation registry: (285 Dabigatran plus aspirin) and (285 Dabigatran plus~     clopidogrel) therapy)] will be comparatively analyzed the safety and efficacy. Primary~     endpoints were a composite of death, non-fatal myocardial infarction, stroke, systemic~     embolism, and GUSTO bleeding (moderate to severe).~   "
73371|NCT02606539|"~     Gestational trophoblastic neoplasm affect women and is sensitive to chemotherapy especially~     methotrexate and the investigators try to find a role of surgery plus methotrexate instead of~     multiple doses and cycles of chemotherapy.~   "
73372|NCT02606526|"~     BCG vaccination may have non-specific effects (NSE) i.e., additional benefits on childhood~     morbidity and mortality that are separate the vaccine's effect on the incidence of~     disseminated tuberculosis. Though the available literature is mostly from observational study~     designs, and is fraught with controversy, BCG vaccination at birth, in a high risk population~     of HIV exposed children, may protect infants against serious infections other than TB. Yet,~     other studies indicate that giving BCG later in infancy, when the immune system is more~     mature, may offer even greater protection. The appropriate timing of BCG vaccination could~     therefore be up for revision. This study will therefore compare BCG vaccination at birth with~     BCG vaccination at 14 weeks of age in HIV exposed (HE) babies.~      Methods: This is an individually randomized clinical trial in 2,200 HIV exposed infants. The~     intervention is an intra-dermal administration of 0.05 ml of BCG vaccine within 24 hours of~     birth while the comparator will be an intra-dermal administration of 0.05ml of BCG vaccine at~     14 weeks of age.~      The main study outcomes include:~        1. Severe illness in the first 14 weeks of life,~        2. TNF, IL‑1b, IL-6 and IFN-γ in response to mycobacterial and non-mycobacterial antigens~          and~        3. Severe illness in the first 14-52 weeks and 0-52 weeks of life.~      The study will be carried in two health Center IIIs and a health center IV in Uganda.~      Implications: A well-timed BCG vaccination could have important additional benefits in HE~     infants. This trial could inform the development of programmatically appropriate timing of~     BCG vaccination for HE infants.~   "
73373|NCT02606513|"~     Tumors of the UUT are rare and usually presenting as micro- or macrohematuria either~     symptomatic or asymptomatic. Rapid advances in CT technology accelerated the research into~     the application of this new technology in the evaluation of the UUT and readily proved to be~     superior to other imaging modalities. Nevertheless the increase in radiation dose is a major~     issue of concern. Initial research into the utility of MRI in the evaluation of the UUT was~     promising, yet the success of CT together with the cost, limited availability and the longer~     duration of MR urography (MRU) examination, nearly halted the investigations into the~     feasibility of MRU which is unfortunate as MRU is a safe alternative to CT.~   "
73374|NCT02606500|"~     The aim of the present study is to determine, whether clinical efficacy of 150 mcg of~     Corifollitropin alfa is the same in normal weighing and obese women. Furthermore,~     investigators want to determine whether oocytes retrieved from normal weighing and obese~     women, after COH using 150 mcg of Corifollitropin alfa, are of same quality on the molecular~     level.~   "
73375|NCT02606487|"~     The investigators aim to assess whether pulmonary MRI (hyperpolarised 129Xe ventilation~     imaging [Xe-MRI]) can detect changes in ventilation defects in patients with CF before and~     after treatment for a pulmonary exacerbation. The investigators will determine whether~     changes seen using pulmonary Xe-MRI are associated with changes in pulmonary function~     (spirometry, lung volumes, lung clearance index [LCI]) in patients with CF before and after~     pulmonary exacerbation.~   "
73376|NCT02606474|"~     Cases of previous cesarean with placenta previa anterior underwent cesarean section. Placenta~     accreta is diagnosed during cesarean section &confirmed by pathology. All complications are~     monitored in cases with placenta accreta and without.~   "
73377|NCT02606461|"~     This is a randomized, multicenter, double-blind, placebo-controlled, Phase 2-3 study of~     patients diagnosed with advanced unresectable dedifferentiated liposarcoma. Approximately 279~     total patients will be randomized to study treatment (selinexor or placebo).~   "
73378|NCT02606448|"~     This is a randomized, single blinded, standard of care controlled clinical trial. All adult~     patients over sixteen desiring anterior cruciate ligament reconstruction will be eligible.~     The study compares pain control and opioid consumption in patients undergoing ACL~     reconstruction between patients receiving liposomal bupivacaine and those who underwent a~     preoperative femoral nerve block.~   "
73379|NCT02606435|"~     This is a prospective, randomized study with blinded outcome assessment, comparing routine~     manual thrombus aspiration with no aspiration in patients with acute ST-segment elevation~     myocardial infarction (STEMI) underwent percutaneous coronary intervention (PCI).~   "
73380|NCT02606422|"~     Primary progressive aphasia (PPA) is a neurodegenerative disease that affects first and~     foremost language abilities. Mild cognitive impairment (MCI) is slowly progressive decline in~     a single domain of cognition (e.g. language) not attributable to motor or sensory loss,~     without impediment of social or occupational function. MCI can be an early sign of~     neurodegenerative disease, or can be due to normal aging. When language is the prominent~     affected domain in MCI, the person may later meet criteria for PPA or may progress to the~     clinical syndrome of Alzheimer's dementia. Spelling, naming, and working memory (e.g.~     repetition) are among the language abilities affected early in the course of PPA or~     language-centered MCI, and different variants have distinct deficits in these domains. This~     research project investigates the behavioral and neuromodulatory effects of transcranial~     direct current stimulation (tDCS) during language therapy in PPA participants over time.~     Anodal tDCS targeting the left inferior frontal gyrus (IFG) administered in combination with~     language therapy is expected to be more beneficial when compared to language therapy alone.~     It will 1) improve language performance or decrease rate of decline, 2) have better-sustained~     effects at 2 weeks and 2 months post-treatment, and 3) produce generalization to untrained~     language items and some other cognitive functions. Resting-state fMRI, diffusion tensor~     imaging (DTI), and volumetric data are also collected to investigate changes in functional~     brain connectivity associated with tDCS in individuals with PPA. A better understanding of~     the therapeutic and neuromodulatory mechanisms of tDCS as an adjunct to language therapy in~     PPA may have a significant impact on the development of effective therapies for PPA and MCI,~     and may offer insight into ways of impeding neurodegeneration that may improve patients'~     quality of life, as well as extend their ability to work and manage their affairs.~   "
73381|NCT02606409|"~     Dexmedetomidine, a central and peripheral α2-receptor agonist distinct from GABA receptor for~     benzodiazepines and propofol, has been approved by the US Food and Drug Administration only~     for use up to 24 h in mechanically ventilated patients. The investigators aim to compare~     dexmedetomidine with propofol for sedation >24h in poly traumatized mechanically ventilated~     patients.~   "
73391|NCT02606279|"~     This study is designed to evaluate specific factors in mitochondria that may precipitate~     premature aging and physical weakness in HIV patients. Angiotensin receptors 1 and 2 (AT1R~     and AT2R) are found in virtually every cell type. This study will evaluate how the~     relationships among these receptors in immune and skeletal muscle cells change with HIV, and~     how these changes might trigger mitochondrial dysfunction, declines in muscle strength, and~     cellular decline in people living with HIV.~   "
73746|NCT02601586|"~     This study will be conducted in three parallel groups receiving oxycodone, levodopa or~     placebo, administered as an add-on therapy, in addition to the usual antiparkinsonian~     treatment. As this study focuses on chronic central neuropathic pain caused by PD, the~     effects of study treatments will be evaluated after a 10-week treatment period~   "
73382|NCT02606396|"~     Esophageal adenocarcinoma (EAC) is one of the few cancers with a rising incidence in the~     United States, with an estimated 17,000 new cases diagnosed in 2012. Most patients with~     esophageal cancer present with tumors which are not amenable to surgery and are treated with~     chemotherapy and radiation. The most common and bothersome symptoms from esophageal cancer is~     dysphagia (difficulty swallowing). Chemotherapy and radiation are effective in shrinking~     tumors and allowing patients with EAC to swallow more easily; however it usually takes 1-2~     months for swallowing to improve with this treatment.~      Another method of shrinking esophageal tumors and allowing for better swallowing is~     endoscopic spray cryotherapy (freezing the tumor from inside the esophagus with the aid of an~     endoscope); cryotherapy is a well established method for treating cancerous and pre-cancerous~     esophageal disease. This is a particularly attractive treatment option, as patients with~     esophageal cancer usually undergo endoscopy on several occasions before starting treatment in~     order to biopsy and evaluate the tumor.~      The goal of this study is to evaluate the effectiveness of cryotherapy in treating EAC~     related dysphagia in patients who are getting ready to start chemotherapy and radiation.~      In order to do this the investigators are planning to invite patients who are already~     undergoing endoscopy for pre-chemotherapy evaluation of known EAC. Patients would undergo~     cryotherapy after the diagnostic portion of the endoscopy has been completed. After the~     cryotherapy patients will be contacted by phone in order to evaluate change in symptoms, 2~     and 4 weeks after cryotherapy.~   "
73383|NCT02606383|"~     This is a non-inferiority, Phase III, open-label, randomized, parallel trial to evaluate the~     new intervention Dapaconazole cream 2% versus Ketoconazole cream 2% in patients with Tinea~     pedis. Sample size is 140 participants (70 per treatment group), male or female, aged between~     16 and 60 years-old.~      Primary objective is to evaluate non-inferiority of Dapaconazole cream 2% compared to~     Ketoconazole cream 2% in Tinea pedis treatment. Secondary objective is to evaluate safety and~     tolerability of Dapaconazole cream 2% after multiple administrations.~      Participants will receive either new intervention or active control during 14 consecutive~     days, which will be followed by 2 follow-up visits.~      Primary efficacy endpoint is clinical and mycological lesion cure, and secondary efficacy~     endpoint is time (days) until clinical diagnosis of lesion cure. Additionally, safety will be~     assessed by adverse events occurrence and laboratory exams evaluation.~   "
73384|NCT02606370|"~     Aim: To compare trunk muscle activity, lumbar spine range of motion (ROM) and LBP during gait~     using an unstable shoe (Intervention group) and a conventional stable control shoe (Control~     Group).~      Design: Randomized Controlled Trial. Setting: A Biomechanics laboratory. Population: Patients~     with Low Back Pain.~   "
73385|NCT02606357|"~     Primary Objective:~      -To assess the change in glycosylated hemoglobin (HbA1c) in uncontrolled Type 2 diabetes~     patients on OAD agent in Jordan after 6 months of treatment with basal insulin (Insulin~     glargine).~      Secondary Objectives:~        -  To evaluate the percentage of patients achieving target of HbA1c ˂7%.~        -  To evaluate the change in fasting plasma glucose (FPG).~        -  To assess the following safety criteria: hypoglycemic events, body weight changes, and~          overall safety.~        -  Describe the titration process: changes in glargine insulin dose at 3 months and 6~          months, changes in the titration doses used (if any), and time to reach control.~   "
73386|NCT02606344|"~     The high rates of HIV infection in women have brought into sharp focus the problem of~     violence against women. There is a growing recognition that women and girls' risk of and~     vulnerability to HIV infection is shaped by deep-rooted and pervasive gender inequalities~     violence against them in particular. The links between intimate partner violence and HIV/AIDS~     are explained by biological as well as sociocultural and economic factors.~   "
73387|NCT02606331|"~     Thirty six patients needs therapeutic extraction of the maxillary first premolars with~     subsequent retraction of the maxillary canines will be divided randomly into two groups :~     piezocision group and the ER:yttrium aluminum garnet (YAG) laser group. In each group,~     piezocision or hard laser-assisted flapless corticotomy will randomly assigned to one side of~     the maxillary arch at the first premolar region, and the other side served as the control.~     Canine retraction will be initiated after completion of the leveling and alignment phase via~     closed nickel-titanium coil springs applying 150 g of force per side, soldered trans-palatal~     arch will be used as an anchor unit.~      Pre- and post distalization dental casts will be evaluated to study rate of canine~     distalization, canine rotation and anchorage loss over a follow-up period until a Class I~     canine relationship is achieved. The levels of pain and discomfort will be self-reported~     using a questionnaire with visual analog scales administered at four assessment times during~     the first month after the minimally invasive procedure.~   "
73388|NCT02606318|"~     The purpose of this study was to clarify the effects on health-related QOL of occupational~     therapy involving the adjustment of challenge-skill balance in the activity of elderly~     clients.~   "
73389|NCT02606305|"~     This is a phase 1b study to assess the safety, tolerability, and preliminary anti-tumor~     activity of IMGN853 when administered with chemotherapy. Patients will be assigned to one of~     four regimens: IMGN853 administered with bevacizumab, IMGN853 administered with carboplatin,~     IMGN853 administered with pegylated liposomal doxorubicin, IMGN853 administered with~     pembrolizumab, or IMGN853 administered with bevacizumab+carboplatin~   "
73390|NCT02606292|"~     Endoscopy is an important technique in medicine to diagnose internal organs. Video endoscopy~     has been the most common technique providing clear, real time video images of organs'~     surfaces. However, this technique only images the surface and cannot effectively diagnose~     diseased tissues that develop in endothelial tissues. Endoscopic ultrasound (EUS) has been~     developed to overcome this limitation, and it is widely utilized in diagnosing GI diseases.~     This technique can image very deep areas of organs, up to several centimeters; however, it~     suffers from speckle artifacts and cannot adequately provide early diagnosis of tissue~     abnormalities that do not show mechanical properties that differ significantly from those of~     normal tissues.~      The investigators propose that photoacoustic endoscopy (PAE), an endoscopic embodiment of the~     rapidly growing photoacoustic tomography (PAT) technology, can fulfill the aforementioned~     need.~   "
73405|NCT02606097|"~     The main purpose of this study is to examine whether regorafenib treatment can help people~     with gastrointestinal stromal tumours (GIST) and have gene mutation on c-kit exon 17. The~     safety of regorafenib treatment is also examined.~   "
73392|NCT02606266|"~     Congenital cytomegalovirus (CMV) infection is the leading cause of non-genetic neurosensory~     deafness and affects 0.5 to 1% of births. Twenty to thirty per cent of children will develop~     deafness, some of whom will progress gradually to profound bilateral deafness.~      No curative treatment is currently offered for this deterioration in hearing and management~     involves the use of a hearing aid or cochlear implant. Many studies describe the utility of~     antiviral treatment on the course of the deafness. These mostly involve neonates with~     multi-system symptomatic forms of the infection who have been given 6 weeks of ganciclovir~     possibly switched to valganciclovir, which has shown benefit in stabilising auditory loss, or~     even improvement.~   "
73393|NCT02606253|"~     Broad Objectives: To determine the comparative efficacy of commonly employed strategies to~     overcome loop diuretic resistance when added to concomitant loop diuretics in hospitalized~     decompensated heart failure patients with hypervolemia~      Specific Aims:~        1. Compare the 48-hour weight change of either intravenous chlorothiazide or oral tolvaptan~          compared to standard-of-care oral metolazone when combined with standardized loop~          diuretic dosing for diuretic resistance in decompensated heart failure~        2. Compare the adverse effects of electrolyte depletion and renal function changes between~          intravenous chlorothiazide or oral tolvaptan compared to standard-of-care oral~          metolazone when combined with standardized loop diuretic dosing for diuretic resistance~          in acute heart failure~        3. Pharmacoeconomic analysis of the direct costs of intravenous chlorothiazide or oral~          tolvaptan compared to standard-of-care oral metolazone when combined with standardized~          loop diuretic dosing for diuretic resistance in acute heart failure~      The investigators will conduct a dual center, randomized, double-blind, double-dummy,~     parallel design trial comparing: oral metolazone, intravenous chlorothiazide, or oral~     tolvaptan, in combination with loop diuretics in 60 patients hospitalized for hypervolemic~     decompensated heart failure and displaying loop diuretic resistance.~   "
73394|NCT02606240|"~     This pilot observational study will assess changes in pH /PaO2 /PaCO2, Respiratory Rate and~     device CO2 clearance in the first 24 hours of Extracorporeal CO2 removal (ECCO2R) following~     tidal volume (Vt), and plateau pressure reduction in patients with mild to moderate ARDS.~   "
73395|NCT02606227|"~     Maternal smoking during pregnancy (MSDP) increases the risk of adverse pregnancy and birth~     outcomes and may have long-lasting effects in the offspring.Financial incentives may increase~     smoking abstinence rate in pregnancy and therefore reduce MSDP related negative health~     effects. This is a randomized open label study comparing financial incentives for smoking~     abstinence with no financial incentives for smoking abstinence.Research objectives~        1. To test the efficacy of financial incentives on smoking abstinence rate among pregnant~          smokers;~        2. To explore the heterogeneity of efficacy according to individual characteristics:~          socioeconomic status, social background, smoking characteristics, personality traits,~          time and risk preferences to determine profiles of women which could benefit best from~          this kind of intervention;~        3. To provide a cost-benefit analysis based on the cost of newborn and children disease due~          to maternal smoking during pregnancy.~   "
73396|NCT02606214|"~     The objective of the study is to evaluate the safety and tolerability of multiple doses of~     TBA-354 in healthy subjects.~   "
73397|NCT02606201|"~     Stress urinary incontinence related to intrinsic sphincter deficiency (ISD) is a severe form~     of incontinence that may have a major impact on the quality of life. The main treatment is~     surgical and consists in the implantation of medical devices such as the artificial urinary~     sphincter, adjustable continence therapy, compressive sling, or injection of bulking agent.~      The investigator has developed a new therapeutic strategy for ISD that consist to implant~     myofibers with their attached satellite cells (the main source of muscle progenitor cells) at~     the vicinity of the striated urethral sphincter. The principle of this method relies on the~     in vivo activation of satellite cells leading to the formation of regenerated myofibers~     (myotubes) generating a distinct and tonic muscular activity . The proof of concept was~     investigated in a Phase I clinical trial: Investigator found that the periurethral~     implantation of myofiber strips around the urethra generated an electromyographic activity~     improving urethral closure pressure in women with severe urinary incontinence associated to~     ISD. In this previous study, the technique of myofiber implantation was invasive, as it~     required a surgical approach and dissection of the urethra to place the myofiber. For the~     clinical trial IPSMA, the investigator sought to optimize the myofiber transplantation~     process using a method injection of myofibers core obtained by hydro-dissection. The~     injection technique is performed percutaneously under fluoroscopic and endoscopic control and~     does not require a surgical approach of the urethra.~      This clinical trial is prospective, open-label, non-randomized, uncontrolled, single-center~     for the first stage and multicenter for the second stage, of 13 months for each patient aims~     to assess the efficacy and safety of IPSMA in the treatment of urinary incontinence in women~     with ISD.~   "
73398|NCT02606188|"~     The purpose of this study is to determine whether the Modified High-flow nasal cannula is~     effective in the oxygen of the patients undergoing bronchoscopy.~   "
73399|NCT02606175|"~     Patients who receive a kidney transplant have to learn in 10-14 days which anti-rejection~     medication to take, how to take it ,... This learning process is attended by the nurses of~     the ward. This study wants to measure the degree of medication knowledge, health literacy and~     medication adherence of those patients.~   "
73400|NCT02606162|"~     The purpose of this study is to determine the outcomes of severe osteoporotic fractures~     hospitalized in France, the risk of incident severe fracture at 2 years and 5 years and the~     risk of mortality over 2 and 5 years.~   "
73401|NCT02606149|"~     Patients with metastatic cancer have a substantial symptom burden and may receive aggressive~     care at the end of life. There is evidence that the use of chemotherapy near the end of life~     is not related to its likelihood of providing benefit and the overuse of aggressive~     anticancer therapies near the end of life may result in more toxicity than clinical benefit.~     Moreover, proposing new lines of treatment after successive therapeutic failures may be a way~     of avoiding discussion of prognosis and advance care planning. It has been proposed that~     systems not providing overly aggressive care near the end of life would be the ones in which~     less than 10% of patients receive chemotherapy in the last 14 days of life. Presently the~     first consultation between patient and oncologist is ruled in France by the first Plan~     Cancer and the Dispositif d'annonce (announcement planning). Oncologists are supposed to~     explain the diagnosis of cancer and to present a treatment plan. In routine practice for~     metastatic non curable cancer patients, chemotherapy is presented as the leading therapy and~     its side effects are explained. The use of chemotherapy has been associated with the~     worsening of two major competitive life-threatening conditions for cancer patients: cachexia~     and thrombo-embolic events. Nevertheless the risk of worsening both those conditions is~     hardly explained in routine practice.~      This study proposes to examine in a monocentric interventional prospective randomized trial,~     the impact of a particular way for the oncologist to present chemotherapy at the diagnosis~     stage on the easiness of timely chemotherapy interruption at the end of life. The main~     objective is to determine whether or not the explanation of the potential role of anticancer~     chemotherapy in worsening life-threatening conditions impacts the proportion of patients~     receiving chemotherapy in the last 30 days of life compared with usual presentation.~     Secondary objectives are to determine the impact of this communication strategy on overall~     survival and other indicators of aggressiveness of care and palliative care resources use.~      The hypothesis is that the intervention will allow 15% of patients receiving anticancer~     therapy during the last 30 days of life, as compared to 30% in the control group.~      The investigators expect that the intervention evaluated in this study will reduce the rate~     of patients receiving chemotherapy during the last 30 days of life hopefully improving the~     quality of end of life care. A secondary objective is overall survival and this study will~     therefore verify that the intervention arm is not associated with poorer overall survival.~     But more probably investigators expect patients in the intervention arm to have an improved~     overall survival mainly link to a decrease in harms due to chemotherapy given near the end of~     life and to better palliative care. In effect the hypothesis is that showing the~     life-threatening risks associated with chemotherapy and thus reducing for patients the~     importance of this treatment will leave room for improved palliative care as shown notably by~     earlier and more frequent referral to palliative care specialists. If this trial is positive,~     it will prove the capital role of patient-doctor communication in cancer care and that few~     differences in communication strategy could improve end of life care and maybe even survival.~     The impact on the oncology community would be major since the intervention could be easily~     transposed in all practices at no additional cost. It would also emphasize the importance of~     communication skills and human relationship in the very technical field of medical oncology.~   "
73402|NCT02606136|"~     This is a Phase 2, open-label, single arm trial of pamrevlumab (FG-3019) to estimate~     pamrevlumab's safety and efficacy in non-ambulatory subjects with DMD.~   "
73403|NCT02606123|"~     The study will consist of 2 parts: Part I (Dose Escalation) and Part II (Dose Expansion). In~     Part I, patients will participate in single, multiple, and long-term dosing periods using~     EPI-506 to determine safety, pharmacokinetics, the maximum tolerated dose, and preliminary~     indications of anti-tumor activity. Part I is an open-label, adaptive 3 + 3 design,~     dose-escalation study. Approximately six dose levels of EPI-506 will be studied, beginning at~     80 mg/day. Enrolled patients may be allowed to escalate to a subsequent dose cohort after~     their initial twelve weeks. Additional patients may be enrolled at any safe dose level prior~     to or concurrent with enrolling patients in Part II.~      In Part II, 3 patient populations; post-abiraterone metastatic castration-resistant prostate~     cancer (mCRPC) but enzalutamide-naïve, post-enzalutamide mCRPC but abiraterone-naïve, and~     post-abiraterone and enzalutamide mCRPC will be studied at the recommended Phase 2 dose~     (RP2D) determined in Part I over 12 weeks of daily dosing. Approximately 120 patients (40 in~     each cohort) will be enrolled.~   "
73404|NCT02606110|"~     The purpose of this study is to investigate the effect of the ReBuilder in the treatment of~     individuals with breast cancer and chemotherapy induced peripheral neuropathy.~   "
73407|NCT02606071|"~     The IRON-MPP is a prospective multicenter, observational registry designed to collect~     clinical and device data from a large cohort of HF patients treated in clinical practice with~     a CRT-D device with the ability to deliver Multi Point Pacing.~      The purpose of the Registry is to collect data on how MPP-devices are being used by~     physicians in order to better understand how to improve the clinical care of patients and~     effectiveness of MPP therapy.~   "
73408|NCT02606058|"~     To establish if placental transfusion, using deferred cord clamping for 60 seconds or more~     while holding the baby at or below the level of the placenta, will improve survival without~     disability compared with standard early cord clamping in preterm babies less than 30 weeks of~     gestation.~   "
73409|NCT02606045|"~     This is an outpatient, 24-week Phase III prospective, randomized, crossover trial comparing~     recombinant von Willebrand factor (rVWF) and tranexamic acid (TA, Lysteda®) to minimize~     menorrhagia in women with type 1 von Willebrand disease (VWD). The purpose of this Phase III~     multicenter prospective, randomized, crossover arm trial is to compare recombinant von~     Willebrand factor (rVWF) to tranexamic acid (TA) in reducing the severity of menorrhagia in~     women with von Willebrand disease.~   "
73410|NCT02606032|"~     The investigators will test the hypothesis that giving antibiotics prior to fecal transplant~     therapy for active UC increases the proportion of patients in remission at the end of~     treatment. The investigators will randomize patients aged 18 or over with active UC to~     antibiotics (metronidazole 500mg, doxycycline 100mg, Terbinafine 250 mg, all twice daily for~     two weeks); or identical placebo. At the end of two weeks the investigators will give all~     patients fecal transplant therapy twice per week for eight weeks from the donor whose stool~     showed most efficacy in the trial (donor B). Patients will complete a validated UC~     questionnaire, have a flexible sigmoidoscopy to assess the degree of inflammation in the~     colon and complete general and disease specific quality of life questionnaire as well as a~     questionnaire on anxiety and depression. Patients will complete the same questionnaires again~     at the end of treatment at week 9 when they will also have a repeat flexible sigmoidoscopy.~     The main outcome that will be assessed is the proportion of patients in remission from their~     UC at the end of treatment.~   "
73411|NCT02606019|"~     The burden of dengue infection has increased due to the current non-specific classification.~     A pilot study was conducted to evaluate the five of the biomarkers: neopterin, vascular~     endothelial growth factor (VEGF), thrombomodulin, Vascular Cell Adhesion Molecule 1 (VCAM-1)~     and pentraxin 3 (PTX-3). VEGF and PTX-3 was the only two potential biomarkers in~     differentiating severe dengue from non-severe dengue cases. The analysis between severe~     dengue and non-severe dengue cases indicated that only VEGF was able to discriminate the two~     categories. Though VCAM-1 and PTX-3 were not statistically significant, the p-values were at~     the margin of the pre-determined p-value of less than 0.05.~      Hence, this study aims to evaluate VEGF and PTX-3 levels in differentiating severe dengue~     from non-severe dengue cases. The secondary objective is to evaluate the correlation of VEGF~     and PTX-3 levels with full blood count (platelet, white blood cell count and haematocrit) and~     liver function test (alanine aminotransferase and aspartate).~   "
73412|NCT02606006|"~     Thousands of canines are used for therapy in health care centers throughout the United States~     as part of a volunteer therapy team, yet little is known about the outcomes provided by these~     teams. Although many studies have been published, few used randomized, controlled formats to~     identify whether canine therapy has an impact and any mechanisms by which any impact may~     occur. The purpose of this study is use a randomized, controlled setup for canine~     animal-assisted therapy (AAT) in patients undergoing inpatient physical therapy for stroke,~     Parkinson's disease, or generalized weakness deconditioning to determine whether use of AAT~     produces desirable outcomes, such as increased motivation, in patients.~   "
73413|NCT02605993|"~     The primary purpose of this study is to evaluate the safety, tolerability, and efficacy of~     multiple IV doses of ALXN1210 administered to complement inhibitor treatment-naïve patients~     with PNH.~   "
73414|NCT02605980|"~     United Kingdom (UK) physical activity guidelines for older people state that All older~     adults should minimise the amount of time spent being sedentary (sitting) for extended~     periods and there is sufficient evidence to support a recommendation to reduce sedentary~     behaviour in older adults, but it is not currently possible to suggest a specific time~     limit. The aim of this study is to identify key physiological and psychological outcomes~     influenced by acute periods of inactivity and what older people feel after these acute~     periods of inactivity. The investigators' main objective is to determine, through direct~     measurement and self report, the acute functional and cognitive effects of differing periods~     of sitting time. A secondary objective is to inform older people, professionals and~     organisations working with older people and policy makers on what duration of sedentary~     behaviour will lead to adverse outcomes in older people. The investigators will recruit~     ambulatory men and women aged 70 y and over who will be studied on three separate occasions,~     approximately one week apart to complete sedentary bouts of 1 h, 2 h and 4 h in a randomised~     crossover design. The investigators will explore the relationship between sitting time and~     changes in lower limb explosive power(primary outcome) measured before and after each bout.~     Secondary outcomes will include timed chair rise; Timed Up and Go; blood pressure; perception~     of musculoskeletal comfort/pain, vitality; mood and cognitive function. The investigators~     will also measure the stress hormone cortisol in samples of saliva taken at the start of the~     sitting session, 1 h, 2h and 4 h later. Characterising the acute effects of sitting time in~     older adults will enable the design of interventions to reduce sedentary time as well as~     inform professionals and policy makers on what duration of sedentary behaviour will lead to~     adverse outcomes.~   "
73415|NCT02605967|"~     The purpose of this randomized controlled Phase II study is to assess the efficacy of PDR001~     versus investigator's choice of chemotherapy in patients with advanced NPC.~      By blocking the interaction between PD-1 and its ligands PD-L1 and PD-L2, PDR001 leads to the~     activation of a T cell mediated antitumor immune response~   "
73416|NCT02605954|"~     This study will evaluate the efficacy of switching to~     elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose~     combination (FDC) relative to continuing on a baseline regimen consisting of~     abacavir/lamivudine (ABC/3TC) plus a 3rd antiretroviral agent in maintaining HIV-1 virologic~     suppression.~   "
73417|NCT02605941|"~     The purpose of this prospective study is to evaluate whether DNA methylation can be applied~     in cervical cancer screening.~   "
73418|NCT02605928|"~     The study focuses on needle guidance in rheumatologic operations - glucocorticoid injections~     inside joint capsules specifically. The main purpose of the study is to assess and validate~     the clinical feasibility and performance of Bioimpedance Probe (BIP) Needles and assess the~     benefits, drawbacks and risks related to use of the BIP Needles.~   "
73891|NCT02599701|"~     The primary objective of this study is to evaluate the effects of gabapentin in sleep~     polysomnography parameters and in nocturnal secretion of endogenous~     hypothalamic-pituitary-adrenal (HPA), hypothalamic-pituitary-gonadal (HPG) and somatotropic~     axes hormones and basal IGF-1 in older men.~   "
73419|NCT02605915|"~     This is a Phase Ib, open-label, two-stage study with two active regimens in each stage~     designed to evaluate the safety and tolerability of combination treatment with atezolizumab,~     trastuzumab, and pertuzumab (with and without docetaxel) or atezolizumab and trastuzumab~     emtansine in participants with human epidermal growth factor receptor 2 (HER2) positive~     metastatic breast cancer (MBC) and locally advanced early breast cancer (EBC), and~     atezolizumab with doxorubicin and cyclophosphamide in HER2-negative breast cancer.~   "
73420|NCT02605902|"~     Gilles da la Tourette syndrome (TS)* is a common chronic neuropsychiatric disorder~     characterized by motor and vocal tics. In most adult patients, quality of life is~     significantly impaired. TS, therefore, is a cost-intensive disease (in Germany: mean total~     costs=€3404/year). Despite significant adverse effects, dopamine receptor antagonists were~     recommended as first choice treatment for many years. Although efficacy could be demonstrated~     only recently, today, behavioral therapy with face-to-face Comprehensive Behavioral~     Intervention for Tics (CBIT) (including psychoeducation, habit reversal training,~     function-based assessment and intervention, and relaxation training) is recommended as first~     line treatment for tics. In Germany, however, dissemination of CBIT is restricted due to a~     considerable lack of well-trained therapists. The aim of this study is to overcome this~     deficiency by creating a new and sophisticated internet-delivered CBIT (iCBIT) program. In~     addition, internet-delivered CBIT will shorten waiting time, will reach additional groups of~     patients and will be - once developed and established - highly cost-effective (about € 100~     vs. € 1450 for face-to-face CBIT). Investigators want to perform a multicenter, randomized,~     controlled, observer-blind trial including 160 adult patients in order to demonstrate that 8~     sessions (10 weeks) of iCBIT are superior to internet-delivered psychoeducation/relaxation in~     adult patients with TS. Both immediate (1 week after end of treatment) and long-term effects~     (after 3 and 6 months) will be evaluated.~   "
73421|NCT02605889|"~     This is a randomized clinical research, with triple blinded multicenter involving the Federal~     University of Rio de Janeiro, through the School of Nursing Anna Nery, as a proponent and~     research coordinator; and as a collaborative educational institutions, the Federal University~     of Espirito Santo, represented by the Department of Nursing; and the Higher School of~     Sciences of the Santa Casa de Misericordia de Vitoria, through the Master's Programme in~     Public Policy and Local Development.~      As Research, the study covers health units of the Municipal Family Health Maricá / Rio de~     Janeiro, the Municipal Victoria Health / Holy Spirit, beyond the scope of Integrated Project~     Research-Service (PIPA), linked to Nursing Anna Nery / Federal University of Rio de Janeiro.~      The object of investigation is the effectiveness of acupuncture in nursing care in~     complementary treatment of adult patients Diabetes Mellitus type II.~   "
73422|NCT02605876|"~     This study will evaluate the acute effects of vibration (whole body vibration and local~     muscle vibration) on quadriceps function, knee joint proprioception, and gait biomechanics~     linked to osteoarthritis development in individuals with anterior cruciate ligament~     reconstruction. Subjects will be randomly assigned to control (no vibration), whole body~     vibration, and local muscle vibration groups, and the aforementioned characteristics will be~     assessed prior to and following the respective interventions.~   "
73423|NCT02605863|"~     The purpose of this study is to examine the effect of androgen deprivation therapy through~     administration of enzalutamide on preventing bladder cancer recurrences in patients with~     non-muscle invasive bladder cancer (NMIBC).~   "
73424|NCT02605850|"~     This study will determine the effects of beneficial compounds of plant foods, such as~     pomegranate on cardiovascular health. This will be tested by asking healthy males to eat a~     high fat ground beef patty with pomegranate juice (PJ), pomegranate extract (PomX) or water~     and then measuring blood vessel dilation (endothelial function) by blood flow We also will~     measure the amount of Nitric Oxide (NO) in your blood and urine samples and sugar and insulin~     in blood. Healthy men have been chosen for this study because eating high fat hamburger~     patties can easily mimic in them the condition that causes atherosclerosis. The results from~     this study may help to explain how high fat foods can be harmful to the body and how~     beneficial plant foods can have on cardiovascular function~   "
73425|NCT02605837|"~     A study in adolescents and adults with eosinophilic esophagitis (EoE) to measure the~     histologic response and determine if any reduction in dysphagia is achieved.~   "
73426|NCT02605824|"~     This study evaluates 20% n-acetylcystine (NAC) in the treatment of moderate-to-severe asthma~     that is complicated by mucus in the airway, as determined by CT imaging. The study is a~     crossover design, which means that half the study participants will get 20% NAC in the first~     7-day treatment period and placebo in the next 7-day treatment period; and the other half~     will get placebo in the first 7-day treatment period and 20% NAC in the next 7-day treatment~     period.~   "
73427|NCT02605811|"~     To investigate the response of temozolomide versus prophylactic cranial radiotherapy in~     preventing brain metastases in completed or partial remission limited small cell lung cancer~     patients.~   "
73428|NCT02605798|"~     Comparative randomized, single dose, three way three sequence two treatment partial replicate~     crossover open-label study to determine the bioequivalence of Sofosbuvir from Elbanovir 400~     mg Film Coated Tablets ( Multi-Apex Pharmaceutical industries, Egypt) versus Sovaldi 400 mg~     Film Coated Tablets (Gilead Sciences International Ltd. Cambridge, United Kingdom)~   "
73429|NCT02605785|"~     This study is designed to learn more about overall tau burden in the brain of patients with~     Progressive Supranuclear Palsy (PSP).~   "
73430|NCT02605772|"~     To investigate the Safety and Efficacy of Acarbose+Saxagliptin Compared With~     Metformin+Saxagliptin in Patients With Type 2 Diabetes,100 patients with T2DM will be~     enrolled in this study.They will randomly be assigned to Acarbose+Saxagliptin or~     Metformin+Saxagliptin group.HbA1c，fasting and postprandial C-peptide will be observed before~     and after the interventions.~   "
73431|NCT02605759|"~     To demonstrate the feasibility, safety and efficacy of the CryoBalloon Ablation System for~     the treatment of esophageal squamous cell dysplasia.~   "
73489|NCT02604979|"~     Sympathetic activity could be increased during robot-assisted laparoscopic gastrectomy, which~     is performed in a head up position under CO2 pneumoperitoneum.~      Stimulation of the sympathetic nervous system prolongs the QT interval and can increases the~     susceptibility to life threatening cardiac arrhythmias.~      Thus the investigators decided to evaluate the heart-rate corrected QT interval (QTc~     interval) during robotic-assisted laparoscopic gastrectomy.~   "
73432|NCT02605746|"~     This is two parallel studies to examine pharmacokinetic (PK), pharmacodynamic (PD), and~     pharmacogenetic (PG) endpoints following short-interval therapy (10-14) daily doses without~     dose reduction and interruption) with the ALK (anaplastic lymphoma kinase) small-molecule~     inhibitor, ceritinib.~      The Phase 0 study will investigate:~        1. first recurrence GBM patients and~        2. patients with CNS metastases from solid tumors such as, but not limited to, NSCLC~          (non-small cell lung cancer) and melanoma.~      The CNS (central nervous system) metastases Phase 0 is designed to identify PK effects (in~     addition to PD, and PG effects on ALK-positive NSCLC metastases), while the GBM Phase 0 is~     designed to identify PK, PD, and PG effects in all patients.~   "
73433|NCT02605733|"~     The purpose of this study is to characterize the normal brain function of premature infants~     (23 to 31+6 weeks GA) during birth transition and through the first 72 hours of life.~   "
73434|NCT02605720|"~     Mass drug administration with antimalarial treatment is a tool that can potentially reduce or~     totally eliminate malaria parasite infections from a population.~     Dihydroartemisinin-piperaquine (DHA/PPQ) given monthly for 3 months to the entire population~     might be a good candidate for mass drug administration because the long acting PPQ exerts a~     long post-treatment prophylactic effect against reinfection and relapse. The use of a~     repeated dose of DHA/PPQ could lead to increased PPQ plasma concentrations and increased~     cardiotoxicity. However, there is no data on a second course of treatment or on safety of the~     drug administered in repeated monthly doses. The proposed project is a clinical trial to~     assess the electrocardiographic safety of monthly DHA/PPQ (for 3 days at a time) for 3~     months. The investigators aim to assess the safety of the drug to be used monthly in mass~     treatment campaigns. Recommendations issued from this study will benefit health authorities~     on Lihir-Island by setting the stage for a possible subsequent campaign to completely~     eliminate malaria from the whole island. This study could be a crucial step to inform the~     feasibility of drug-based strategies for eliminating malaria elsewhere in PNG, other~     Melanesian countries and throughout the world.~   "
73435|NCT02605707|"~     Stroke is a frequently occurring and common diseases in nervous system,and most of the~     survivors will remain disorders of motor,sensory and cognition function.Stem cell~     transplantation provides a promising approach for rehabilitation. The main objective of this~     study is to evaluate the efficacy and safy of the transplantation of autologous endothelial~     progenitor cells in patients with chronic stroke.~   "
73436|NCT02605694|"~     Phase II study to evaluate the efficacy and safety of DR vs R-CHOP in subjects with~     relapsed/refractory FL~   "
73437|NCT02605681|"~     The purpose of this study is to assess the relationship between midkine level and ACE-Ang II~     induced endothelial injury in sepsis.~   "
73438|NCT02605668|"~     PROTECT-AD is a cognitive behavioral treatment study involving highly qualified~     psychotherapeutic centers at seven German universities.~      It is our goal to further investigate and optimize existing effective treatments of anxiety~     disorders. In order to achieve this, the investigators want to investigate the effect of~     extinction learning in an intensified psychological intervention on treatment outcome in~     adults and children with anxiety disorders.~      The intensified psychological intervention is characterized by a higher number of exposure~     trials over a short time period. In the control condition the exposure trials take place in a~     weekly interval, analog to standard care.~   "
73439|NCT02605655|"~     The purpose of this study is to determine whether the Chinese formula AMP-1915 has effect on~     Metabolic Syndrome (MS) in MS patients. Half of patients received AMP-1915, while the other~     half received placebo.~   "
73440|NCT02605642|"~     To assess persistence of Inflectra in patients with Rheumatoid Disease (Rheumatoid arthritis~     [RA], ankylosing spondylitis [AS], and psoriatic arthritis [PsA]) who are naive to biologics~     or are switching over from stable Remicade to Inflectra. The main objectives of the study~     are:~        -  To evaluate real-life drug persistence in RA, AS, and PsA patients who are either~          initiated with Inflectra™ as their first biologic, or who are switched from stable~          Remicade™~        -  To characterise the patient populations and drug usage patterns of RA, AS, and PsA~          patients who are either initiated with Inflectra™ as their first biologic, or who are~          switched from stable Remicade™~        -  To assess the safety of Inflectra™ in RA, AS, and PsA patients who are either initiated~          with Inflectra™ as their first biologic, or who are switched from stable Remicade for up~          to 2 years~   "
73441|NCT02605629|"~     This study aims to evaluate the Impact of a topical Lotion, CG428, on permanent chemotherapy~     induced hair and scalp disorders in Cancer survivors. This is a double-blind, single center,~     randomized, controlled trial in breast cancer survivors.~      Hair condition and parameters of 61 breast cancer survivors who were previously included in~     DERMA study (a prospective cohort study to assess appearance changes due to breast cancer~     treatment completed in July, 13th,2013) will be assessed.~        1. Patients whose hair parameters are below the baseline as measured before the start of~          the chemotherapy or~        2. who complain from incomplete hair regrowth will be eligible to participate in the~          randomized controlled trial.~      Patients who agree to participant in the study will be randomly assigned to two parallel arms~     (Arm 1: CG428/ Arm 2: Placebo). Patients will self-administer the study product or placebo~     twice per day (morning, evening) for 6 months, for the efficacy assessment.~      Primary endpoint was recovery of hair thickness 6 months after intervention as assessed using~     Folliscope 4.0.~      Secondary endpoints included hair density at 6 months after intervention, distress due to~     chemotherapy induced alopecia, scalp skin parameters (water and sebum). Patient-reported hair~     quality improvement, body image and quality of life, and time to first visible improvement~     based on global photographs of hair and nails.~   "
73442|NCT02605616|"~     Does the novel drug decrease liver fat in subjects with NASH or NAFLD as compared to placebo~   "
73443|NCT02605603|"~     This project is expected to elucidate role of different therapeutic interventions: SRT in~     comparison to ERT in influencing immune aspects of GD pathology, as well as bone involvement.~   "
73444|NCT02605590|"~     This study will be performed to assess the safety, tolerability and PK of escalating inhaled~     AIR-DNase doses administered as a single dose followed by multiple doses for 5 consecutive~     days in healthy subjects.~      A thorough review of safety data will be conducted after completion of each dose level per~     subject and prior to both, moving to the next dose level in Part 1 and commencement of the~     multiple dose Part 2.~   "
73445|NCT02605577|"~     The purpose of the project is to investigate the status of nutrition management of late~     preterm infants in the member hospitals in the Beijing association of preterm infants, and~     set up the systemic nutritional management of late preterm infants, Including parenteral~     nutrition and enteral feeding. And to compare the differences of growth and complications of~     these infants between groupings applicationg and not applicating the systemic nutritional~     management of late preterm infants,and to validate its feasibility and validity.~   "
73446|NCT02605564|"~     The central hypothesis of this proposal is that a gluten-free diet introduced shortly after~     diagnosis can reverse or arrest islet destruction in children and adolescents with type 1~     diabetes mellitus (T1DM). The specific aims are to determine the effects of a gluten-free~     diet on 1) endogenous insulin production and 2) the corresponding gut flora of children with~     new-onset type 1 diabetes. This is a randomized placebo controlled clinical trial testing the~     effect of altering the gut microbiome via a gluten-free diet on endogenous insulin production~     as a measure of the pace and severity of islet destruction at the time of diagnosis of type 1~     diabetes. The project entails eliminating gluten from the diet of the intervention group and~     comparing bacterial gut flora and endogenous insulin response with those in a control group~     up to one year following the diagnosis of type 1 diabetes. The proposal introduces a new~     potential etiology for type 1 diabetes in humans: the Bacterial Hypothesis. The short term~     goal is to identify specific islet-preserving microbiome changes induced by eliminating~     gluten from the diet of patients recently diagnosed with type 1 diabetes. The long term goal~     is to develop these changes into effective and safe strategies that can allow patients with~     type 1 diabetes to achieve permanent insulin-independence.~   "
73447|NCT02605551|"~     The goal of this study is to demonstrate the use of osteopathic manipulative therapy (OMT) in~     the effective management of hypertension. The investigators hypothesize that by~     addressing/correcting somatic dysfunctions with OMT, the sympathetic overdrive that could be~     the root cause of the elevation in blood pressure will be downregulated. If this is the case,~     then an effective therapy for hypertension could indeed be regular OMT treatment. This could~     also result in the avoidance of potentially harmful antihypertensive medications which~     comprise a majority of the current therapeutic strategy in the treatment of hypertension~     (along with lifestyle modification). A third implication of the results of this project could~     be a reduction in the progression of this disease. Under the current standard of care, a~     majority of hypertensive patients only experience a worsening of the disease over time under~     the current therapeutic guidelines.~   "
73448|NCT02605538|"~     CF patients are at risk for hepatic disease. Vaccination is recommended to all CF patients~     according to European consensus. The aim of the study is to vaccinate as many patients as~     possible and to follow up whether immunization has been complete.~   "
73449|NCT02605525|"~     The purpose of this study is to assess the efficacy and safety of SM101 in the treatment of~     Immunoglobulin A nephropathy (IgAN)~   "
73450|NCT02605512|"~     Breast radiotherapy RT used until the 1990s was clearly responsible for increased mortality~     due to long term cardiac complications. Since the 2000s, improvements have appeared in dose~     distributions to organ at risks such as heart, but now, little is known on the risk of~     potential cardiac impairment in this population, in particular for chemotherapy naive~     patients. Based on the state that clinically detectable cardiotoxicity is generally preceded~     by subclinical cardiac dysfunctions, the aim of the BACCARAT study (BreAst Cancer and~     Cardiotoxicity induced by RAdioTherapy) is to evaluate whether adjuvant 3DCRT induces cardiac~     toxicity that could be detected in the first two years after treatment based on a global~     approach with repeated analysis of subclinical functional and anatomical cardiac lesions in~     myocardial and coronary levels and circulating biomarkers.~   "
73451|NCT02605499|"~     This study examines the impact of UV-C light disinfection as an adjunct to routine daily and~     discharge patient room cleaning on patient infection and colonization with hospital~     associated bacteria.~   "
73452|NCT02605486|"~     The purpose of this study is to test the safety and effectiveness of the investigational~     drug, palbociclib with bicalutamide for the treatment of triple negative, androgen receptor~     positive breast cancer.~   "
73453|NCT02605473|"~     The goal of the first phase of this clinical research study was to find the highest tolerable~     dose of decitabine and peginterferon alfa-2b that can be given in combination to patients~     with melanoma. The first phase was completed but the study did not progress to the second~     phase.~      The goals of the second phase of this clinical research are to learn if decitabine and~     peginterferon alfa-2b combined can help to control melanoma, and to find out which doses are~     more effective and/or better tolerated.~   "
73454|NCT02605460|"~     The purpose of this study is to evaluate the disease free survival and the overall survival~     in patients with acute leukemia in first or second complete remission after administrating a~     CXCR4 antagonist, as a chemo sensitization strategy, plus chemotherapy as the conditioning~     regimen for autologous or allogeneic hematopoietic stem cell transplantation (HSCT).~   "
73455|NCT02605447|"~     The EVOLVE Short DAPT Study is a prospective, multicenter, single-arm study designed to~     assess the safety of 3-month DAPT in subjects at high risk for bleeding undergoing PCI with a~     SYNERGY Stent System.~   "
73456|NCT02605434|"~     The purpose of this study is to determine whether the gastric retentive Accordion Pill™~     Carbidopa/Levodopa (AP-CD/LD) is more effective than the commercially available immediate~     release Carbidopa/Levodopa in reducing motor fluctuations such as off time in advanced~     Parkinson's Disease patients.~   "
73457|NCT02605421|"~     This is a phase II single center study to administer two courses of myeloablative~     consolidation chemotherapy each followed by an autologous peripheral blood stem cell (PBSC)~     rescue in patients with high-risk neuroblastoma who have completed induction chemotherapy~     (independent of this study). Ideally, patients should begin consolidation chemotherapy no~     later than 8 weeks after the start of Induction Cycle #5; however it is strongly recommended~     to begin consolidation within 4-6 weeks after the start of Induction Cycle #5.~   "
73458|NCT02605408|"~     The purpose of this study is to record and analyze the profile and outcome of cataract~     patients receiving phacoemulsification (phaco) and artificial intraocular lens (IOL)~     implantation with or without femtosecond laser-assisted cataract surgery (FLACS) in Indian~     tertiary medical centers.~   "
73892|NCT02599688|"~     This is an open-label, observational extension of patients who received POLAT-001 in~     LipoLat-CS202.~   "
73459|NCT02605395|"~     This is an open-label, randomized, single dose, two-sequence, two-periods crossover study,~     separated by 7 days washout interval from the first Study Drug Administration. This study is~     conducted to determine the bioequivalence of Rabeprazole from IDIAZOLE 20mg Delayed-Release~     (DR) tablets (tabs) and PARIET 20 mg DR tabs after a single oral dose administration of each~     to healthy adults fed under conditions.~      In Period 1, subjects will be randomized to either Idiazole 20mg DR tabs or PARIET 20 mg DR~     tabs. Following a washout of at least 7 days, subjects will be crossed over in Period 2 to~     receive the treatment that they did not receive in Period 1.~      PARIET is a registered trademark of EISAI Co. Limited.~   "
73460|NCT02605382|"~     The purpose of this study is to analyze the efficacy of 0.12% chlorhexidine gluconate as a~     chemical adjuvant for the treatment of peri-implant mucositis, in a non-surgical treatment~     protocol with a six-month follow-up.~   "
73461|NCT02605369|"~     Universal coverage of good quality facility based care globally could prevent nearly 113,000~     maternal deaths, 531,000 stillbirths and 1.3 million neonatal deaths annually by 2020. Yet,~     only 57% of pregnant Ugandan women choose to deliver at health facilities. This unacceptably~     low coverage of facility based births could explain, in part, the high maternal and perinatal~     mortality estimates in Uganda. While multiple studies have examined factors associated with~     this low utilization of health services around the time of birth, there is inadequate~     implementation research exploring the best systematic methods that could promote uptake and~     scale up of facility based births. This study will therefore examine the effect of an~     intervention package (peer counselling by pregnancy buddies on facility based births, mobile~     phone messaging promoting facility based births and provision of mama-kits) on the frequency~     of facility based births and perinatal mortality. The study, a cluster randomized community~     based intervention trial in post-conflict Northern Uganda, will provide data crucial in~     framing national policy regarding measures to promote the use of health facilities.~   "
73462|NCT02605356|"~     This study will be conducted in 2 parts. The phase 1b part will be an international, phase~     1b, open-label, dose-escalation assessment of radium-223 dichloride administered with~     bortezomib and dexamethasone in subjects with relapsed multiple myeloma. The primary endpoint~     of the phase 1b part is to determine the optimal dose of radium-223 dichloride in combination~     with bortezomib/dexamethasone for the Phase 2 portion of the study.~      The phase 2 part will be an international, phase 2, double-blind, randomized,~     placebo-controlled assessment of radium-223 dichloride versus placebo administered with~     bortezomib and dexamethasone, in subjects with relapsed multiple myeloma. Randomization (1:1)~     in the phase 2 part will be stratified by:~        -  Prior bortezomib treatment (yes, no)~        -  Prior treatment (1 prior line of treatment, >1 prior line of treatment) Approximately 30~          subjects (10 subjects per cohort) will be enrolled in the phase 1b part of the study and~          approximately 196 subjects will be enrolled in the phase 2 part of the study.~   "
73463|NCT02605343|"~     The purpose of this study is to evaluate the effect of pharmacogenetics (PGx) guided~     treatment when implemented into the pre-operative process for patients undergoing bowel~     surgery, major urologic procedure, or major ventral hernia repair and requiring~     post-operative acute pain management in an inpatient basis, as compared to a group of~     subjects with the same attributes without the guidance of PGx testing (historical control~     group). This study will also evaluate the frequency with which the standard analgesic care~     plan is adjusted by test results.~   "
73464|NCT02605330|"~     The study intends to measure fibrinogen plasma levels during the first 24 hrs in cardiac and~     thoracic surgical patients who undergo surgical procedures using extracorporeal circulation.~   "
73465|NCT02605317|"~     The aim of this study is to determinate outcomes of WhatsApp Messenger (a messaging program~     for smart phones) usage for Communication Between Consulting Physicians and the Emergency~     Physicians.~   "
73466|NCT02605304|"~     People who are infected with Hepatitis C Virus (HCV) have a great chance of being cured of~     the infection when they are treated with sofosbuvir. However, in some instances, treatment~     with sofosbuvir-containing therapy does not work. It is not known if people respond to~     retreatment with sofosbuvir, after it did not work the first time. There is an important need~     to understand retreatment options in those instances. This clinical trial was done to study~     the response to two different regimens, ledipasvir/sofosbuvir and ledipasvir/sofosbuvir with~     ribavirin, and to see if they are safe and well-tolerated in HCV-infected persons whose~     previous treatment with sofosbuvir had failed.~   "
73467|NCT02605291|"~     This study will investigate the effect of dietary macronutrient manipulation on glycogen~     (stored carbohydrate) levels in the muscle and substrate oxidation during exercise. The~     investigators will investigate the hypothesis that manipulating the macronutrient content of~     the diet will alter the levels of glycogen in the muscle and, in turn, substrate oxidation~     during exercise.~   "
73468|NCT02605278|"~     This study evaluates whether the implementation of an integrated clinical program for chronic~     musculoskeletal pain and depression behave better clinical outcomes than the usual approach~     in primary care~   "
73469|NCT02605265|"~     The study evaluate the addition of Irinotecan in neoadjuvant chemoradiation. Half of~     participants will receive capecitabine alone together with neoadjuvant CRT, followed by a~     cycle of XELOX, while the other will receive capecitabine and irinotecan during CRT, followed~     by a cycle of XELIRI. All participants will be scheduled to receive surgery 6-8 weeks after~     the completion of CRT, then 5 cycles of adjuvant chemotherapy of XELOX.~   "
73470|NCT02605252|"~     As HBsAg clearance is uncommon in chronic hepatitis B (CHB) patients on nucleoside analogues~     (NAs) therapy. The purpose of this study is to optimize HBsAg clearance in CHB Patients with~     sequential treatment of pegylated interferon alpha-2b and NAs.~   "
73471|NCT02605239|"~     58 patients between 18 and 76 years who attended the Operative Dentistry Clinic at Dental~     School, Universidad de Chile, were included in the study. Those patients were bleaching and~     included in this study and signed a consent form. The patients were treated with 10%~     carbamide peroxide (CP) gel (Whiteness Perfect, FGM) to each subject with verbal instructions~     for 3 weeks with daily applications of 1 hour according to manufacturers indications , before~     and after this procedure was applied again the OHIP-Esthetics , PIDAQ and OES questionnaire~     form, had 30 minutes to answer it, were completed before , immediately after and one month~     control post-bleaching procedure.~   "
73472|NCT02605226|"~     This trial is going to evaluate tumor control and quality of life in patients with prostate~     cancer treated with radiotherapy or cryoablation.~   "
73473|NCT02605213|"~     Primary sclerotic cholangitis (PSC) is an inflammatory process of sclerotic cholangitis that~     involves intra and extra hepatic biliary system. There is no curative treatment for this~     disorder. Supportive and conservative treatments are the most common therapies that used for~     this disease. Although treatments such as ursodeoxycholic acid (UDCA) are recommended in some~     situations but whereas a hypothesis is stimulatory effect of intestinal anaerobic bacteria~     such as cholestridium difficile as pathogenesıs of PSC, so use of antibiotics is recommended~     for treatment of these patients. Therefore according to the great role of anaerobic bacteria~     such as cholestridium difficile in pathogenesis, antibiotics such as metronidazole and~     vancomycin can be counted as recommended therapies in PSC. In addition some studies~     correlated this effect of vancomycin to its immunomudulatory effect the cause reduction of~     inflammation in biliary system. But with all this detail there is no finality about~     effectiveness of antibiotic therapy and accordingly in this study the investigators compare~     oral vancomycin effect versus placebo in primary sclerosing cholangitis patients.~      In this double blind clinical trial 30 primary sclerosing cholangitis patients that divided~     in two 15 persosns group with Block Randomization method. in this study one group receive 250~     mg oral vancomycin every 6 hours and other group receive placebo.~      The study duration is 12 weeks . The baseline laboratory tests and 1 month and 3 months after~     treatment concept of; Alkaline phosphatase, ALT, AST, GGT and serum total bilirubin and~     clinical manifestations such as tiredness, itching and probable adverse effects such as~     hypotension accompanied by flushing,erythematous rash on face and upper body (red neck or red~     man syndrome), chills and drug fever, eosinophilia and reversible neutropenia.~   "
73474|NCT02605200|"~     The purpose of this study is to determine the influence of post-transplant diabetes on~     medical and psychosocial outcomes in individuals who receive solid-organ transplant prior to~     18 years of age and their families.~   "
73475|NCT02605187|"~     The ability to predict pain and then apply modified treatment protocols has been limited.~     Current practice is for physicians to select standard post-operative pain treatment protocols~     without patient consultation. This study hopes to determine if patient's involvement in~     analgesic drug/dosage selection can optimize pain relief while minimizing related side~     effects. This could result in a more patient-centered care model and individualized~     perioperative analgesic treatment protocols based on patient's preferences, needs and~     expectations.~   "
73476|NCT02605174|"~     This is a prospective randomized, double-blind, placebo-controlled study in participants with~     disabling migraine (Migraine Disability Assessment (MIDAS) score ≥ 11).~   "
73477|NCT02605161|"~     The purpose of this study is to evaluate the blood brain barrier in the striatum of patients~     that have other types of movement disorders compared to patients with Parkinson's Disease~     that are receiving similar treatment, to determine if a there is a disruption of the blood~     brain barrier in patients with Parkinson's Disease.~   "
73478|NCT02605148|"~     To evaluate the effect of Gluten Free Diet (GFD) on beta-cell function and glucose metabolism~     in subjects with one or several islet autoantibodies without and with dysglycemia at~     baseline. Additionally, all subjects will be given treatment with Vitamin D, omega fatty~     acids and probiotics.~      Subjects will be randomized to GFD or normal diet during 18 months. Beta cell function will~     be evaluated at baseline, and during follow-up by glucose tolerance tests.~   "
73479|NCT02605135|"~     The ability to determine the postmenopausal vaginal environment and the impact of pessary use~     could help to maximize pessary therapy and non-surgical treatment for such a prevalent~     problem.~   "
73480|NCT02605122|"~     This is a phase 2/3, randomized, open-label, active control, multi-center study to assess the~     safety and efficacy of solithromycin in children and adolescents with community-acquired~     bacterial pneumonia (CABP).~   "
73481|NCT02605109|"~     This study aimed to analysis the characteristics of MERS transmission and the effect of our~     institutional personal protective equipment on the controlling the MERS at a tertiary Korean~     Hospital.~   "
73482|NCT02605096|"~     This pilot study aims to test the feasibility and work flows associated with using MRI as the~     initial imaging modality in the investigation of patients presenting with suspected scaphoid~     fracture.~      This pilot will be used to inform the design of a study that will aim to evaluate whether the~     proposed intervention is likely to generate cost-savings whilst improving or maintaining~     overall patient quality of life and satisfaction.~   "
73483|NCT02605083|"~     This clinical trial is a Phase 1-2, open-label, sequential-group, dose-escalation and~     cohort-expansion study evaluating the safety, pharmacokinetics, pharmacodynamics, and~     antitumor activity of daily oral administration of eFT508.~   "
73484|NCT02605070|"~     Single center, prospective, open clinical study to determine the genomic imprint (epigenetic~     modification) in a series of male infertility patients with alterations in their spermiogram~     (oligozoospermia) compared to a group of fertile patients in order to evaluate the effect of~     FSH ( follicle stimulating hormone) administration on these modifications and on male~     infertility.~   "
73485|NCT02605057|"~     Given that LEO 80185 gel takes effect in the upper layer of the skin, it is important to~     compare and examine the amount of the drug in the upper layer of the skin with that of~     Dovobet® Ointment. Therefore, a dermatopharmacokinetic study will be conducted in healty~     adult male volunteers to evaluate pharmacokinetics of LEO 80185 gel and Dovobet® Ointment in~     the stratum corneum. In this trial, a single application of LEO 80185 gel and Dovobet®~     ointment will be applied to multiple test sites on the back of healthy Japanese male adults~     and the trial is designed to compare the amount of each of the active ingredients at steady~     state or close-to-steady state between LEO 80185 gel and Dovobet® Ointment. The amount of~     calcipotriol and betamethasone dipropionate in the stratum corneum will be assessed by use of~     tape stripping.~   "
73486|NCT02605044|"~     The objective is to compare the efficacy and safety of masitinib in combination with FOLFIRI~     ( irinotecan, 5-fluorouracil and folinic acid) to placebo in combination with FOLFIRI in~     second line treatment of patients.~   "
73487|NCT02605005|"~     The aim of this study is to investigate the relationship between the patient positioning in~     the beach chair position with consequential arterial pressure changes and their influence on~     regional cerebral oxygen saturation under two anesthesia techniques, general anesthesia in~     one group of patients and interscalene block in the second group of patients.~   "
73488|NCT02604992|"~     The primary objective of this study is to evaluate the comparative bioavailability of a test~     product of dronabinol oral solution administered under fed conditions to the reference listed~     drug (RLD) administered to participants under fed and fasted conditions.~      The secondary objective is to compare the onset of detectable dronabinol concentrations~     between dronabinol oral solution and the RLD.~   "
73522|NCT02604550|"~     The objective of this study is to compare the pain control benefit of two different types of~     nerve blocks in patients undergoing anterior cruciate ligament (ACL) reconstruction.~   "
73490|NCT02604966|"~     At the end of 2012, the Institute of Tropical Medicine in collaboration with National~     Institute of Malariology Parasitology and Entomology (NIMPE) conducted a study in Quang Nam~     province, central Vietnam, to assess the efficacy of the national DHA-PPQ regimen for the~     treatment of uncomplicated P. falciparum malaria infections, both in adults and in children.~     Results showed that about 30% of the study participants were parasitaemic at day 3. Parasite~     clearance rate was estimated at 6.2h, which was comparable to figures from Pailin, Cambodia,~     where artemisinin resistance were previously reported . However, results from this study have~     to be interpreted bearing in mind that: (i) the age-based drug dosing scheme used has been~     criticized as insufficient to clear parasites and (ii) DHA-PPQ drugs used (Artecan™),~     Vietnam, are not produced under Good Manufacturing Practices (GMPs). However, those results~     prompted the NMCP and WHO to declare Quang Nam, Binh Phuoc, Dak Nong, and Gia Lai provinces~     as a Tier I area (credible evidence of artemisinin resistance) in May 2013. By end of 2014~     a fifth province, Khanh Hoa, was declared Tier I (Dr Hong, Personal Communication). Except~     for the south-eastern province of Binh Phuoc, artemisinin resistance has never been confirmed~     with an artemisinin based monotherapy in Central Vietnam.~      Therefore, in order to confirm artemisinin resistance in Central Vietnam , a study with oral~     artemisinin-based monotherapy, using WHO prequalified AS and DHA-PPQ and recommended dosing~     scheme of 4mg/kg/day for AS and DHA, is needed. In the arm where study participants are~     treated with 3 days of AS monotherapy, treatment will be followed by an additional 3-day~     course of DHA-PPQ to effectively clear all parasites.~      The aim of the present study is to confirm artemisinin resistance in Central Vietnam by~     assessing P. falciparum clearance time and rate after AS monotherapy (WHO recommended~     dosage). The investigators will conduct a two-arm open label, randomized study, with one arm~     receiving AS monotherapy for 3 days + 3-day of DHA-PPQ, and a second arm receiving 3 days of~     DHA-PPQ.~   "
73491|NCT02604953|"~     Wills Eye Hospital Glaucoma Research Center will conduct a 1-year prospective study to assess~     the ability of a Short Duration Transient Visual Evoked Potential (SD- tVEP) and a~     Steady-State Pattern electro-retinogram (PERG) vision testing system to detect visual~     dysfunction in patients with ocular hypertension. The study aims to assess the reversibility~     of retinal ganglion cell (RGC) dysfunction after administering intraocular pressure (IOP)~     lowering treatment. The investigators hypothesize that SD-tVEP and PERG testing will help~     develop better treatment for glaucoma patients by increasing understanding of the~     physiological relationship of IOP and RGC in glaucomatous injury.~   "
73492|NCT02604940|"~     The purpose of the study is to determine whether a single bolus dose of dexmedetomidine~     administered during bariatric surgery has any effect on the amount of narcotic pain~     medications required by an individual after surgery. Patients who undergo weight loss surgery~     will be randomized into two groups - group one -dexmedetomidine group and group two- control~     group. Both groups will receive a standard anesthetic. Control group will receive weight~     based dose of fentanyl (standard narcotic pain reliever), intravenous acetaminophen~     (non-narcotic pain reliever), and 60ml saline. Experimental group will receive weight based~     dose of fentanyl (standard narcotic pain reliever), intravenous acetaminophen (non-narcotic~     pain reliever), and dexmedetomidine (given as 1mcg/kg over 10 minutes Intravenous). The~     Patient will then awaken after surgery in post anesthetic recovery unit and be given a~     patient controlled analgesia (PCA) pump with hydromorphone (long acting narcotic pain~     reliever). The amount of hydromorphone used will be recorded by the PACU nurse to the~     electronic health record ( routine practice) in the two groups and compared for pain medicine~     requirements. Secondary endpoints will be Visual Analog Score (VAS) pain score, respiratory~     rate, heart rate, blood pressure oxygen saturation and respiratory rate. All will be recorded~     at 30,60,90,120 and 240 minutes in the electronic medical record in PACU and compared between~     the two groups . All the data - Intra operative and Post -operative - Post Anesthesia Care~     Unit ( PACU) data will be retrieved from the electronic Medical record (EMR). All~     intra-operative data is automatically computed into the patients EMR. All PACU data is~     routinely entered into the EMR by the PACU nurse including the PCA data.~   "
73493|NCT02604927|"~     Paralympians competing in wheelchair sports may experience a very high glycolytic demand (and~     therefore acidotic environment) in their upper-body muscles, particularly in high-intensity~     disciplines. Previous studies from our group have shown that upper-body exercise is very~     sensitive to the ergogenic effects of β-alanine supplementation and to other nutritional~     supplements capable of increasing buffering capacity. In line with this, have shown that~     upper-body muscle groups benefit more from artificially induced alkalosis than lower-body~     muscle groups. Although β-alanine appears to be an interesting and potential ergogenic~     supplement for paralympians, no study to date has assessed its potential in wheelchair~     athletes.In this study, we will evaluate the effects of β-alanine supplementation on~     upper-body performance in wheelchair athletes.~   "
73494|NCT02604914|"~     An Open-Label Study in Healthy Male and Female Subjects to Identify the Concentration that~     Provides Optimal Bioavailability of Levodopa Infused Subcutaneously via a Pump System; and to~     Compare the Bioavailability of Levodopa/Carbidopa Solution to that of Levodopa/Carbidopa~     Intestinal Gel (LCIG), Infused via a Naso-Jejunal Tube~   "
73495|NCT02604901|"~     The 4-arm factorial design RCT tested the impact of a behavioral intervention (SBI or BI), a~     reminder device (Pillbox), and the combination of the two on adherence in adult patients who~     filled a prescription for oral medications to treat diabetes or hyperlipidemia.~   "
73496|NCT02604888|"~     The purpose of this study is to determine whether the Hair Loss Prevention Lotion named~     MEXIS, M.P.A.F., M6S PATENT is effective in the treatment of Alopecia Areata.~   "
73497|NCT02604875|"~     The circadian rhythm of copeptin will be examined in healthy subjects.~   "
73498|NCT02604862|"~     While the process of fibrosis is essential for normal wound healing, an excessive and~     uncontrolled 'fibrotic' response can result in impaired tissue structure and function. In~     other words, affected 'fibrotic' tissues are unable to heal back to normal and therefore~     don't work as effectively as they normally would.~      In the case of the lung, fibrosis can occur across large parts of the lung such as in~     conditions like Idiopathic Pulmonary Fibrosis (IPF) and sarcoidosis or it can occur in much~     smaller patches such as around the borders of some lung tumours. At the moment the~     investigators don't fully understand the mechanisms of fibrosis and so therefore cannot~     monitor or treat these conditions as effectively as the investigators could. Despite the~     significant global financial burden of these diseases, treatment options are very limited and~     monitoring of disease progression remains a real challenge.~      In an effort to address this problem, the research team have designed and synthesised an~     imaging agent (FIB ONE) that can detect fibrosis in the lung. FIB ONE will be used at very~     low concentrations in patients with a lung condition characterised by excessive activity of~     the fibroproliferative pathway either scheduled for a routine bronchoscopy or elective~     surgery. FIB ONE will be administered directly into the lungs during a bronchoscopy procedure~     and images of the lungs will be analysed. As part of this study, the research team's novel~     endomicroscopy detection system will be compared to equipment that is routinely used in the~     NHS when imaging the FIB ONE probe.~   "
73499|NCT02604849|"~     The identification of all cases (44 patients) was carried out from the database of~     microbiology, University Hospital Reina Sofía and the University Hospital of Jerez. For the~     identification of controls, in case of neutropenic patients, all colonized patients that were~     included during the study period did not receive any decolonitation treatment; in case of~     non-neutropenic patients it was studied a paired control by the presence of risk factors that~     indicated the beginning of decolonitation treatment.~   "
73500|NCT02604836|"~     This study will investigate participant satisfaction (including compliance, preference,~     tolerability) with once-monthly Bonviva in women with post-menopausal osteoporosis or~     osteopenia transitioned from once-weekly alendronate or risedronate. The anticipated time on~     study treatment is 6 months, and the target sample size is 1776 individuals.~   "
73501|NCT02604823|"~     This is a study of the efficacy and safety of peginterferon alfa-2a (Pegasys) in naive,~     interferon- or lamivudine-pretreated participants with HBeAg-positive chronic HBV. Following~     48 weeks treatment, there will be a 24 week period of treatment-free follow-up. The~     anticipated time on study treatment is 3-12 months, and the target sample size is 100-500~     individuals.~   "
73502|NCT02604810|"~     This study was designed to determine a dose of weekly subcutaneously administered Immune~     Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (Grifols) (IGSC 20%)~     that produces steady-state AUC of total IgG that is non-inferior to that of the regularly~     administered intravenous dose of Immune Globulin Injection (Human), 10%~     Caprylate/Chromatography Purified (Grifols) (IGIV-C 10%) in primary immunodeficiency~     subjects. This study was also designed to determine steady state trough total IgG levels~     after IGSC 20% infusion and after IGIV-C 10% infusion for comparison and to assess the safety~     and tolerability of IGSC 20%.~   "
73503|NCT02604797|"~     Cesarean section may result in great trauma and postoperative pain. Besides incision pain,~     uterine contraction pain is another source of postoperative pain after cesarean section. In~     clinical practice, a large amount of uterine contraction agent is routinely applied after~     cesarean section so as to promote involution of uterus and reduce postoperative hemorrhage,~     which also causes great uterine contraction pain. Acute pain is the risk factor of chronic~     pain, and may postpone the recovery from labour and influence the quality of life of~     parturient. Though various analgesia modules have been attempted, more than 20% parturients~     still experience severe postoperative pain, and pain management after cesarean section~     remains a challenge to anesthesiologists.~      This study aim to compare the effects of nalbuphine hydrochloride vs sufentanil citrate on~     patient-controlled intravenous analgesia after cesarean section.~   "
73504|NCT02604784|"~     Single center, open label, phase I-II, non-randomized, two-cohort, repeated single dose study~     to explore the feasibility, efficacy, safety, and Overall Response Rate (ORR) of oxaliplatin,~     or cisplatin and doxorubicin when given as a pressurized intraperitoneal chemotherapy (PIPAC)~     to patients (men and women) with peritoneal carcinomatosis from ovarian, gastric and~     colorectal cancers and in primary cancers of peritoneum.~   "
73505|NCT02604771|"~     This study is an epidemiological non-interventional trial that aims to evaluate standard~     daily practice in managing patients with arterial hypertension. The trial only records~     real-life clinical practice with no additional diagnostic or monitoring procedures.~      The study is purposed to collect the following Egypt-specific epidemiology data on~     hypertension: demographic data, patients' characteristics, and patients' management/treatment~     in order to reach its rationale.~   "
73506|NCT02604758|"~     The aim of the study was to determine the effect of the psychiatric nursing approach based on~     the Tidal Model on coping and self-esteem in people with alcohol dependency.~   "
73507|NCT02604745|"~     The main objective of this project is to determine intermediate-term echocardiographic~     outcomes in Medicare eligible patients (65 years of age and older) with moderate surgical~     risk who have undergone mitral valve surgery for degenerative mitral regurgitation.~   "
73508|NCT02604732|"~     The study is designed to assess the need to stop Aspirin before laparoscopic inguinal hernia~     repair. It will consist of 2 groups: patients who continue to take Aspirin and patients who~     stop Aspirin 1 week before the surgery. Randomization will be by closed envelope method. The~     surgeon will be blinded for the usage of Aspirin. Primary outcome is the rate of~     post-operative seroma or hematoma within the fist 24 hours after surgery. Secondary outcomes~     are post-operative pain at regular intervals, post-operative seroma and hematoma after 24~     hours and other post-operative complications.~   "
73509|NCT02604719|"~     The aim of this study is to compare the effect of low dose of Tranexamic acid (1gm) and~     Ethamsylate (1gm) after prophylactic oxytocin administration versus placebo with prophylactic~     oxytocin given in the 2 minutes after child delivery in patient undergoing LSCS at high risk~     for post partum hemorrhage~   "
73510|NCT02604706|"~     Background. A common alternative treatment for substance abuse is ear acupuncture. The aim of~     the study was to evaluate the short and long-term effect of auricular acupuncture on anxiety,~     sleep, drug use and addiction treatment utilization in adults with substance abuse. Method.~     Adults with substance abuse and psychiatric comorbidity were randomly assigned to either of~     two variants of auricular acupuncture - The National Acupuncture Detoxification Association~     protocol (NADA) or a local protocol (LP) - or relaxation training (controls). Primary~     outcomes were measured using the Beck Anxiety Inventory (BAI) and Insomnia Severity Index~     (ISI) with assessment before treatment and follow-ups after five weeks and three months.~     Secondary outcomes were drug use and addiction service utilization.~   "
73523|NCT02604537|"~     The purpose of this study is to determine if corticosteriod injection modifies the natural~     course of de Quervain tendinopathy compared to a toradol injection.~   "
73524|NCT02604524|"~     The biggest challenges for glycemic control during the day time involve meals and exercise~     variations, which are impacted by age, fitness level, duration, intensity and history of~     exercise. Meal variability has the benefit that meals are typically announced and quantified.~     Glucose control around exercise, on the other hand, is more complicated if the patient~     doesn't announce a change in activity level.~   "
73525|NCT02604511|"~     This research study is studying a drug called ibrutinib as a possible treatment for untreated~     Waldenstrom's Macroglobulinemia (WM).~   "
73893|NCT02599675|"~     This study evaluates the effect of vitamin D supplementation on outcomes muscle performance~     and characteristics in 70 trained healthy individuals (18-40 years of age). Subjects will be~     allocated to ingest either vitamin D (35) or placebo (35) in a double-blinded fashion~   "
73511|NCT02604693|"~     This study will provide important results for each aim, while also providing an integrative~     transcriptional and epigenomic profile of CBD.~      In Aim 1 the Investigator will define genome-wide epigenetic alterations of CBD, by~     determining genes that are DM in pivotal immune cells, in the target organ (CD4+ BAL cells)~     in CBD compared to BeS and healthy controls. In addition, the Investigator will determine the~     impact of Be exposure on the methylation profile of CBD and BeS cells compared to each other~     and normal controls. This information will be used to define DM regions, genes and their~     networks.~      Using the cases and controls from Aim 1, we will evaluate the gene-expression from these same~     subjects in Aim 2 to define functional epigenetic loci based on DE in CD4+ BAL cells with and~     without Be exposure. The Investigator will also integrate ENCODE/RE methylation, histone~     modification, and chromatin accessibility data as well as our genome-wide association study~     (GWAS) data to prioritize epigenetic marks and networks for confirmation and validation in~     Aim 3. In Aim 3, the Investigator will test the generalizability of their findings, explore~     the potential of methylation marks as biomarkers of disease in PBMCs and determine if change~     in methylation of these targets with AZA or folic acid affects key immune and regulatory~     pathways in a second set of CBD and BeS subjects. Throughout the Aims, the Investigator will~     use both fresh CD4+ T cells to directly assess disease relevance and Be-stimulated cultured~     CD4+ T cells (compared to unstimulated cultured T cells) to assess the impact of~     environmental exposure .~   "
73512|NCT02604680|"~     The objective of the study is to compare the safety and efficacy of multiple formulations of~     BLI1100 to a control group and placebo in treating patients with moderate-severe acne~     vulgaris.~   "
73513|NCT02604667|"~     The purpose of this study is to better understand the causes of stroke in people with cancer.~     Active cancer increases the risk of stroke. The investigators do not know exactly why this~     occurs but one possible reason is that people with cancer may have thicker blood than people~     without cancer. Thick blood can sometimes cause blood clots to form in the heart, which can~     then travel to the brain and cause stroke. This study is being done to help figure out why~     this and other causes of stroke occur in people with cancer. The investigators expect that~     information from this study will help doctors to more effectively prevent and treat stroke in~     individuals with cancer.~   "
73514|NCT02604654|"~     The purpose of the prospective study is to evaluate the effectiveness and safety of~     Yiqitongluo granule in the treatment of stroke with qi-deficiency and blood-stasis in more~     than sixy hospitals all over China.~   "
73515|NCT02604641|"~     Objective of the study is to determine the influence of dietary supplementation with coenzyme~     Q10 (CoQ10) on skin conditions. 33 healthy female subjects will be randomly assigned to a~     placebo group, a low-dose (LD) group receiving 50 mg CoQ10/day and a high-dose group (HD)~     receiving 150 mg CoQ10/day (11 subjects per group). A water-soluble form of CoQ10 with~     improved bioavailability (Quvital syrup with Q10vital®, Valens Int. d.o.o., Slovenia) will be~     used. Various skin parameters will be evaluated before the supplementation (the baseline),~     after 6 and after 12 weeks of supplementation. To evaluate the photoprotective potential of~     CoQ10 the minimal erythema dose (MED) will be determined before (the baseline) and after 12~     weeks of the supplementation.~   "
73516|NCT02604628|"~     The purpose of this study is to determine the effect of a multifaceted antibiotic stewardship~     intervention on protocol adherence of moderate-severe community-acquired pneumonia.~   "
73517|NCT02604615|"~     A two-arm (two cycles' versus four cycles' capecitabine combined oxaliplatin concurrent~     radiotherapy) randomised Phase III clinical trial was started in Oct. 2015. Definitive~     chemoradiotherapy is the standard regimen in Western countries for patients with esophageal~     cancer who can't receive surgery or reject surgery. But in China because of its severer toxic~     reaction, most of patients had to discontinue treatment at the halfway way. Thus, the~     chemotherapy regimen of capecitabine combined oxaliplatin are widely used in clinical due to~     its characristic of low toxic reaction.~      The purpose of this study is to confirm the efficacy and safety of the different cycles(two~     cycles and four cycles ) of Capecitabine-oxaliplatin in Chinese esophageal squamous carcinoma~     radical concurrent chemoradiotherapy. A total of 60 patients will be accrued from China~     within 2 years. The primary endpoint is overall survival and the secondary endpoints include~     progression-free survival, response rate, pathologic complete response rate and adverse~     events.~   "
73518|NCT02604602|"~     Objective is to analyze a possible association of coagulation factors peripartal with the~     occurrence of postpartum hemorrhage.~   "
73519|NCT02604589|"~     Rib fractures are common injuries in accident patients and can be associated with significant~     pain during recovery. If poorly controlled, pain from splinting due to rib fractures can~     result in difficulty in breathing leading to incomplete expansion of lung, and even the need~     to put a patient on a ventilator to help them breathe. Therefore, pain control is critical in~     managing patients with rib fractures. To date, many studies have shown the effectiveness of~     continuous intercostal nerve blockade (a slow release of pain medications at the site of~     injury that prevents the transmission of pain signals). This approach has never been studied~     in a randomized fashion in rib fracture patients, and has never been compared to~     patient-controlled narcotic pain medication, commonly used at many hospitals. The purpose of~     this study is to evaluate the effectiveness of the placement of an elastomeric infusion pump~     (a small, external, wearable balloon used to deliver medication over time) attached to a~     continuous infusion catheter or soaker catheter (a tube which releases the pain medication~     through tiny holes in it, right at the site of injury) to deliver local anesthetic medication~     to reduce pain caused by two or more rib fractures.~   "
73520|NCT02604576|"~     Multi-center, randomized, superiority, double blind clinical trial to asses the efficacy of~     fixed-dose combination of bromopride and simethicone versus isolated bromopride on research~     participants diagnosed with functional dyspepsia.~   "
73521|NCT02604563|"~     In this study the investigators will incorporate a wide range of clinical variables~     associated with aging to determine whether they are associated with mutation status~     independent of chronologic age. Clinically, aging can be operationalized using geriatric~     assessment, which entails a comprehensive multi-dimensional assessment of the health of an~     older adult, including measures of comorbidity, polypharmacy, functional status, cognition,~     depression, falls, social activities and social support. Given that aging is heterogeneous,~     geriatric assessment allows greater specificity for aging than chronological age alone.~   "
73526|NCT02604498|"~     This is a single center, open-label, non-randomized, 1:1 parallel control and single dose~     administration study design. Healthy subjects will be matched to moderate hepatic function~     impaired (Child-Pugh B，7-9) subjects in age, gender and weight as parallel control, which~     matches healthy with normal hepatic function according to the of subjects with impaired~     hepatic function as, after enrollment of subjects with moderate impaired hepatic function~     (Child-Pugh B，7-9). Hepatic function impaired group and control group both receive orally~     single-dose of nemonoxacin malate capsule (0.5g). Collect the blood and urine samples before~     and after the administration to perform pharmacokinetic analysis and safety observation.~   "
73527|NCT02604485|"~     The purpose of this study is to evaluate the safety and clinical pharmacology of a single~     dose pharmacokinetics and pharmacodynamics of XOMA 358 in subjects with hypoglycemia~     associated with congenital hyperinsulinism.~   "
73528|NCT02604472|"~     To investigate whether the additional induction chemotherapy (IC) to concurrent~     chemoradiotherapy (CCRT) was able to improve overall survival (OS) and disease-free survival~     (DFS), and to clarify if stage-specified chemoradiotherapy regimens benefit the most for~     locoregionally advanced NPC.~   "
73529|NCT02604459|"~     Postoperative delirium occurs in up to 65% of elders undergoing surgery for repair of a hip~     fracture and this complication is independently associated with increased morbidity,~     mortality, length of hospital stay, and placement in long-term care institutions. To date,~     the only intervention shown to be effective at minimizing postoperative delirium is a~     proactive geriatric consultation. This prospective randomized clinical trial will randomize~     160 adults, aged 65 years or older, to either optimized general anesthesia or usual general~     anesthesia care for hip fracture surgery to determine if the optimized anesthesia management~     reduces the severity of postoperative delirium.~   "
73530|NCT02604446|"~     This study will provide knowledge about the use of long-acting opioids for pain relief after~     primary knee arthroplasty. The investigators will compare depot tapentadol, depot oxycodone~     and placebo for effect on pain relief and side effects. The three study groups reflect the~     three different postoperative pain regimens that have been used the last years at St. Olavs~     Hospital, so investigators know that no patient will receive an inadequate pain treatment.~     The purpose of the study is to find which of the three treatments that gives the best pain~     relief with the least amount of side effects. The results will be of use for postoperative~     pain treatment for knee arthroplasty, but also for other types of major surgery. Similar~     studies that are not sponsored by pharmaceutical industry have not been published yet.~   "
73531|NCT02604433|"~     This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study to~     determine the efficacy and safety of luspatercept (ACE-536) plus Best supportive care (BSC)~     versus placebo plus BSC in adults who require regular red blood cell transfusion due to~     (β)-thalassemia.~      The study is divided into the Screening/Run-in Period, double-blind Treatment Period,~     double-blind Long-term Treatment Period, and Post-treatment Follow-up Period.~   "
73532|NCT02604420|"~     Mortality in the major thrombotic microangiopathies (TMAs), TTP and aHUS, exceeds 90% unless~     rapidly diagnosed and appropriately treated. TMAs complicate 10-20% of allogeneic bone marrow~     hematopoietic stem cell transplants (alloHSCT), conveying inferior survival. Multiple~     etiologies have been proposed for these transplant-associated TMAs (TA-TMAs), but once~     infection, graft vs. host disease (GvHD), and drug effects have been ruled out, most are~     treated as TTP-like disorders using plasma exchange (PEx). But PEx has no impact on mortality~     in this setting. Clear definition of the pathophysiology of the TA-TMAs is required to guide~     effective treatment. Investigators hypothesize that an aHUS-type TMA, related to~     dysregulation of the alternative complement pathway, is involved and will be characterized by~     elevated plasma levels of C5b-9 and detectable C5b-9 deposition in bone marrow sinusoidal~     vessels. Investigators further hypothesize that treatment with inhibitors of terminal~     complement components will reverse the TMA in vivo, and block endothelial cell damage in our~     in vitro model systems. The data investigators generate from this observational study of~     TA-TMAs should enable prediction of their development prior to overt clinical manifestations,~     and guide appropriate therapy.~   "
73533|NCT02604407|"~     The study is designed to evaluate the efficacy and safety of each dose of SHP465 (12.5 and~     37.5 mg) given to participants daily in the morning compared to placebo in the treatment of~     adults aged 18 to 55 years diagnosed with ADHD.~   "
73534|NCT02604394|"~     Coronary obstruction by an occlusive thrombus complicating a ruptured or eroded~     atherosclerotic plaque is the most frequent pathologic substrate of acute myocardial~     infarction (AMI).~      Timely restoration of perfusion and thereby myocardial salvage is the single most important~     objective in the management of patients with ST segment-elevation myocardial infarction~     (STEMI).~      To address these uncertainties, our study aims to evaluate the role of RT in patients who are~     most likely to benefit from it (thrombus grade 4 and 5) using a sensitive, quantitative, and~     reproducible parameter; CMR-derived myocardial salvage. also, to determine whether Rheolytic~     Thrombectomy (RT) before conventional PCI to the culprit vessel as compared to conventional~     PCI (with or without MTA) results in improved myocardial salvage; and to identify clinical~     and angiographic determinants of any difference observed between both treatment groups.~   "
73535|NCT02604381|"~     The primary objective of the study is to assess the effectiveness of alpha-D Glucosamine~     Sulfate/Standardized Extract of Ginkgo Biloba Leaf versus a comparator product on~     osteoarthritis pain as assessed by the between group change in WOMAC™ Osteoarthritis Index~     Pain Subscale using Visual Analogue Scale (VAS) scores in subjects with osteoarthritis of the~     knee.~   "
73536|NCT02604368|"~     The purpose of this study is to determine whether treatment of sickle cell patients with~     docosahexaenoic omega-3 acid (DHA) is effective in prevention of acute sickle cell crisis.~   "
73537|NCT02604355|"~     This is a multiple-center, randomized, double-blind, placebo-controlled, single-ascending~     dose and multiple-ascending dose, adaptive parallel study to investigate the safety,~     tolerability, pharmacokinetics and pharmacodynamics of RO7020322 following oral~     administration in healthy participants and chronic hepatitis B patients.~   "
73553|NCT02604147|"~     Investigate the effects of Inspiratory Muscle Training on the physical performance and~     cardiorespiratory variables of wheelchair basketball players.~   "
73554|NCT02604134|"~     This pilot trial compares conventional restorations with a new strategy based on the medical~     management of caries using silver nitrate and fluoride varnish with no restorations.~   "
73538|NCT02604342|"~     This randomized active-controlled multicenter Phase III open-label study will evaluate and~     compare between treatment groups the efficacy of alectinib versus chemotherapy in~     participants with ALK-positive advanced NSCLC who were previously treated with chemotherapy~     and crizotinib, as measured by investigator-assessed progression-free survival (PFS) and to~     evaluate and compare between treatment groups the central nervous system (CNS) objective~     response rate (C-ORR) in participants with measurable CNS metastases at baseline, as assessed~     by an Independent Review Committee (IRC).~   "
73539|NCT02604329|"~     Low Level Laser Therapy has been used for a few years in some pediatric hospital centers for~     chemo- and radiotherapy-induced oral mucositis care. It may promote ulceration's healing,~     limits mucositis severity and associated pain. As its use is recommended in the treatment of~     radio induced mucositis in adults, the level of evidence in pediatric studies does not allow~     a precise treatment protocol. The investigators present here the protocol of a feasibility~     study in the haemato-oncology department of the Children University Hospital of Toulouse,~     with the view to a future efficacy study.~   "
73540|NCT02604316|"~     The proposed study will address the effect of developed novel food products through~     processing innovation on motivation to eat, biomarkers of satiety, nutrient bioavailability~     and gut health using in vivo studies and validating new in vivo approaches.~      Specifically in this protocol the investigators will address, in a short human intervention~     study the effect of a potentially satiating product on appetite, appetite biomarkers,~     particularly the influence on gut microbiota, tolerance and safety of the products in healthy~     obese and overweight participants in free living conditions.~   "
73541|NCT02604303|"~     Abdominal aortic aneurysm (AAA) disease is an abnormal bulging of the main abdominal artery,~     which is the called the abdominal aorta. The purpose of this observational study is to~     identify whether a blood biomarker protein RhoA can predict which small AAA patients may need~     surgery in the future.~      Participating patients will receive an ultrasound and blood draw. The patients will be~     divided into expanding and stable aorta groups after determining each patient's aortic~     expansion rate. The blood RhoA levels and aortic expansion rates between both groups would~     then be compared to look for any relationships.~   "
73542|NCT02604290|"~     The purpose of this study is to determine whether the kinesio taping method is effective in~     the treatment of chronic (more than six months duration) low back pain.~   "
73543|NCT02604277|"~     The purpose of this study is to learn the environmental and psychological factors that impact~     suicidality in patients diagnosed with Bipolar Disorder. Additionally, the study aims to~     identify treatments to reduce the suicidal behavior and improve quality of life through a~     6-week group-based intervention program.~   "
73544|NCT02604264|"~     To assess positive blood cultures (PBCs) in hemodialysis central venous catheter (CVC)~     patients using two FDA cleared devices: ClearGuard HD end caps compared to conventional end~     caps.~   "
73545|NCT02604251|"~     This is a multicenter, randomized, prospective, controlled study in patients having bilateral~     breast reduction. Objectives of the study are to evaluate the safety and efficacy of the KLOX~     BioPhotonic WoundGel System compared with the ones of Silicone Sheets in the treatment of~     surgical wounds.~   "
73546|NCT02604238|"~     The primary aim of this study is to evaluate whether mid dose (safe dose) of Alteplase in~     addition to standard treatment with heparin (LMWH) in patients with pulmonary embolism (PE)~     at intermediate risk, it is effective to reduce:~        -  right ventricular dysfunction~        -  pulmonary hypertension 24 hours and 7 days after the treatment~        -  PE recurrence to 7days and 30 days after the treatment without increasing the incidence~          of bleeding intra-extracranial~   "
73547|NCT02604225|"~     A phase 3 double-blind placebo-controlled randomized trial of methoxyflurane with~     periprostatic local anaesthesia to reduce the discomfort of transrectal ultrasound-guided~     prostate biopsy (Pain-Free TRUS B).~   "
73548|NCT02604212|"~     Patients with HBeAG positive, chronic Hepatitis B Virus (HBV) infection will receive either~     ARC-520 or placebo in combination with entecavir or tenofovir, and be evaluated for safety~     and efficacy.~   "
73549|NCT02604199|"~     Patients with chronic Hepatitis B Virus (HBV) infection will receive either ARC-520 or~     placebo in combination with entecavir or tenofovir, and be evaluated for safety and efficacy.~   "
73550|NCT02604186|"~     Hereditary spastic paraplegias constitute a heterogeneous group of diseases with the common~     predominant feature of spasticity of the lower limbs. The clinical picture is composed of~     difficulty walking, exaggerated deep reflexes, pathological reflexes such as the Babinski~     sign, sphincter disturbances and various degrees of weakness as well as sensory disturbances.~      Spasticity is the symptom that provoques greater incapacity. Although there have been recent~     advances in the genetic and pathogenic characterization of SPG there is scarcity of~     therapeutic options. The Botulinum Toxin (BTx) is a well established treatment for movement~     disorders such as cervical dystonia, blepharospasm, and arm spastic following stroke.~      Therefore, the investigators propose the execution of a randomized, double-blind,~     placebo-controlled, crossover study to evaluate the efficacy of the treatment with Btx over~     SPG patient's gait. The primary outcome measure will be gait velocity with the 10 meter~     walking test 8 weeks after injection. Each participant will be submitted to one injection~     session of Btx and one of placebo (consisting of sterile sodium chloride), each one separated~     by a period of 6 months. The primary and secondary outcomes will be evaluated by a blind~     investigator 8 weeks after each injection session.~   "
73551|NCT02604173|"~     This study is designed to be the first to examine the novel drug budesonide for prevention of~     acute mountain sickness in comparison to acetazolamide and in the context of rapid ascent to~     high altitude. The investigators will accomplish these objectives with a prospective, double~     blinded view of a large population of hikers who are ascending at their own rate in a true~     hiking environment.~   "
73552|NCT02604160|"~     This study is not intended to treat anemia of chronic kidney disease but to determine the~     safety of the study drug, LY3113593.~      The study will also evaluate how much of the study drug gets into the blood stream, how long~     it takes the body to remove the study drug, and what effect the study drug has on the body.~      The study consists of up to three parts. Participants may only enroll in one part.~     Participants will receive up to four injections of LY3113593 or placebo into a vein. The~     study will last up to about 26 weeks including screening and follow-up.~   "
73555|NCT02604121|"~     Prospective study of diagnosis validation of a cytological technique. 200 patients with oral~     cavity cancerous and precancerous lesions will be enrolled.~      A cytological sample of the lesion will be performed by transepithelial brushing ( Orcellex®~     Rovers brush) in cytology liquid-based technology (methode ThinPrep 2000 (Hologic®)). A~     microscopic double blind reading will be performed. A biopsy sampling will be carried out in~     accordance with current strategy of screening. The brushing diagnosis quality will be~     compared to the biopsy which is the gold standard.~   "
73556|NCT02604108|"~     This training program is a part of Happy Family Kitchen Movement Project, which is a~     community-based research project with 3 main components for data collection - training~     programs, community-based family interventions and public education events. The training~     program involves various organizations, including non-government organizations and schools~     across districts in different regions of Hong Kong.~      In the study, the investigators would use training programs as a capacity building method and~     an essential media delivering the holistic health knowledge (positive psychology, physical~     activity, healthy diet) to the public. The project team will provide training program for the~     participants, including: (i) train-the-trainer workshops for the social service workers, who~     will conduct community-based family intervention programs; and (ii) train-the-trainer~     ambassadors for the volunteers who may assist to implement health-related activities for the~     public.~   "
73557|NCT02604095|"~     Effect of Melatonin on Body Composition, Glucose Metabolism and Lipid Metabolism.~   "
73558|NCT02604082|"~     Randomized clinical trial, conducted in the Intensive Care Unit of the Hospital de Clinicas~     de Porto Alegre from october 2011 until november 2015 .~   "
73559|NCT02604069|"~     A simple device that objectively assesses flap perfusion - either as a stand-alone tool or an~     adjunct to the current monitoring method - would be a tremendous improvement in detection of~     early postoperative flap ischemia and, in turn, increase flap salvage and survival. In this~     study, the investigators aim to examine the accuracy and reliability of measuring~     interstitial glucose levels using Continuous Glucose Monitoring (CGM) technology as an~     objective method of detecting postoperative flap tissue ischemia in patients undergoing free~     flap-based reconstructive surgery.~   "
73560|NCT02604056|"~     Two arm, pragmatic, cluster-randomized trial, with nursing homes allocated to the full,~     active intervention (featuring educational outreach offered to each prescriber and team~     members in the home) or standard quality improvement supports (including online audit and~     feedback reports for each prescriber in the home). The 'standard' quality improvement~     supports represent 'usual care' as these are to be launched province-wide; a concurrent~     control arm with no exposure to a quality improvement intervention is not feasible.~   "
73561|NCT02604043|"~     This is a pilot prospective cohort study of the incidence of supraglottic pH readings.~   "
73562|NCT02604030|"~     Our objective is to identify the possible changes of three-dimensional scapula movement~     during arm elevation in women after breast cancer surgery and subjected to a physical therapy~     intervention. Also to evaluate pain, upper limb function and quality of life. Methods: Will~     be evaluated 25 women with a clinical diagnosis of breast cancer and 25 healthy controls~     women with no history of musculoskeletal disorders of upper limbs and matched with age and~     body mass index. Two pre-surgical evaluations in the month prior to surgical treatment of~     breast cancer and two post-surgical assessments are going to be assess: the first, after 4~     weeks after surgery, when patients have received 8 sessions of physical therapy in upper~     limb; the second, after 8 weeks after surgery, when patients completed 16 sessions of~     physical therapy for shoulder complex . In each evaluation, bilateral scapular kinematics~     will be analyzed by an electromagnetic tracking device during arm elevation in scapula plane,~     in breast cancer group. Range of motion will by assessed by a digital inclinometer and muscle~     strength by a hand held dynamometer. Also, pain will be assessed by visual analog scale and~     upper limb function by DASH questionnaire. Quality of life is going to be evaluated by 36~     questionnaire -item Short Form Health Survey (SF36).~   "
73563|NCT02604017|"~     This study seeks to evaluate the efficacy and safety of ABT-493/ABT-530 in participants with~     Genotype 1 hepatitis C virus infection without cirrhosis~   "
73564|NCT02604004|"~     The objective of this research is to check whether the test drug (lamivudine in the form of~     coated tablet 150 mg) achieves plasma levels equivalent to those obtained from the EPIVIR in~     the form of coated tablet 150 mg GlaxoSmithKline administered to 28 volunteers of both genres~     under fasting condition.~   "
73565|NCT02603991|"~     Prospective cohort study on the long-term effectiveness and safety of PINS vagus nerve~     stimulators for children and adolescent with refractory epilepsy.~   "
73566|NCT02603978|"~     The purpose of this study is to determine whether (a) a brief alcohol intervention, (b) a~     brief bystander and social norms intervention, or (c) a brief alcohol and a brief bystander~     and social norms intervention are effective at reducing alcohol use and sexual-related~     behaviors among college men mandated to receive an alcohol intervention by their university.~   "
73567|NCT02603965|"~     This pilot phase I trial studies copper Cu 64 TP3805 (Cu-64-TP3805) positron emission~     tomography (PET)/computed tomography (CT) in detecting cancer in patients with prostate~     cancer undergoing surgery to remove the entire prostate and some of the tissue around it~     (radical prostatectomy). Many patients with benign lesions must undergo biopsy to test the~     lesion. Cu-64-TP3805 is a radioactive substance that attaches to cancer cells but not normal~     cells. PET/CT uses a scanner to make detailed, computerized pictures of areas inside the body~     where the radioactive substance is lighting up. Using Cu-64-TP3805 PET/CT scans and comparing~     them with cancer tissue obtained from surgery may help doctors learn whether Cu-64-TP3805~     PET/CT can accurately detect prostate lesions and determine whether they are cancerous or~     benign, which may minimize the need for prostate biopsies.~   "
73568|NCT02603952|"~     The purpose of this study is to evaluate safety and tolerability of a single dose of MEDI8852~     when given with oseltamivir, the safety and tolerability of oseltamivir alone, and the safety~     and tolerability of a single dose of MEDI8852 alone in adult subjects with acute,~     uncomplicated influenza caused by Type A strains.~   "
73580|NCT02603796|"~     Facial scans of newborns will be performed before and after implementation of respiratory~     support devices such as nasal CPAP. 3D scanned images will be processed by Fisher & Paykel~     Healthcare Limited. Images will be analyzed for changes or distortion in nasal structure.~   "
73569|NCT02603939|"~     Osteoarthritis (OA)is a painful and disabling disease, predicted to be the fourth largest~     cause of disability worldwide by 2020. It commonly affects the hip or knee ultimately~     resulting in total joint replacement. In order to assess disease progression and plan~     surgery, x-rays are taken as part of routine practice. However x-rays provide limited~     information about formation of substructures and changes occurring during progression of~     disease. The proposed study aims to invite patients with OA of the hip or knee to participate~     in detailed examinations of their pain and their painful joint through interviews, blood and~     urine samples taken, MRI magnetic resonance imaging)and donating their waste tissue after~     joint surgery (all of old joint). Informed patient consent will be sought in all cases.~   "
73570|NCT02603926|"~     The purpose of this study is to examine the safety and efficacy of Allopregnanolone as a~     possible treatment for symptoms of Fragile X-associated Tremor/Ataxia Syndrome (FXTAS).~   "
73571|NCT02603913|"~     Pregnancy complications like pre-eclampsia (PE), pregnancy induced hypertension (PIH),~     intra-uterine growth restriction (IUGR) and preterm labor (PTL), (i.e. the major part of~     complications in pregnancy) are related to an impaired endothelial function. Endothelial~     dysfunction accounts for altered vascular reactivity, activation of the coagulation cascade~     and loss of vascular integrity. Nitric oxide (NO), a free radical molecule derived from~     L-Arginine by NOS (Nitric Oxide Synthase), is an endogenous endothelium-derived relaxing~     factor influencing endothelial function. In the placental circulation, endothelial release of~     NO dilates the fetal placental vascular bed and thus ensures feto-maternal exchange. The~     impaired endothelial function in pregnancy complications originates from production of~     inflammatory and cytotoxic factors by the ischemic placenta and results in oxidative stress~     and an altered bioavailability of NO. Measurement of endothelial function using peripheral~     artery tonometry and determination of ROS (reactive oxygen species) and RNS (reactive~     nitrogen species) using Electron Paramagnetic Resonance (EPR) gives an idea of the oxidative~     stress that took place and the degree of endothelial dysfunction that occurred during~     pregnancy.~   "
73572|NCT02603900|"~     The study is a prospective randomized controlled trial comparing local infiltration of~     analgesia in the knee joint and adductor canal catheters for postoperative analgesia~     following a primary Total Knee Arthroplasty (TKA).~   "
73573|NCT02603887|"~     The goal of this clinical research study is to learn if Keytruda (pembrolizumab) can help to~     control intermediate- or high-risk smoldering multiple myeloma (SMM). The safety of this drug~     will also be studied.~      This is an investigational study. Pembrolizumab is FDA approved for the treatment of certain~     types of melanoma. Its use in patients with SMM is investigational.The study doctor can~     explain how the study drug is designed to work.~      Up to 13 participants will be enrolled in this study. All will take part at MD Anderson.~   "
73574|NCT02603874|"~     The current method of incision localization in many surgical procedures requires a doctor to~     reference a medical image, such as an X-ray, to judge where on the body an incision should be~     made. However, the precise information of the scan is not shown on the patient's skin.~     Surgeons commonly use palpation to locate the point of incision. They may feel for the area~     directly or find landmarks under the skin and estimate the location from there. This can be~     challenging due to the difficulty of feeling and distinguishing each vertebra, especially for~     new surgeons, since palpation is a skill derived through experience.~      If palpation proves ineffective, they may be forced to use fluoroscopy. By referencing the~     fluoroscopy image the surgeon moves a radiopaque marker, such as their surgical tool, closer~     to the area of interest. Fluoroscopy is time-consuming, and exposes medical personnel and the~     patient to radiation. Many fluoroscopic images may be required in a single procedure. The~     purpose of this study is to test the efficacy and benefits of a new medical device that will~     aid in radiological localization. The hypothesized outcome would be smaller incisions, faster~     localization and a reduction in fluoroscopy use.~      By identifying the efficacy of this new medical device, Target Tape, there is the potential~     outcome of making smaller incisions, faster localization, a reduction in fluoroscopy use and~     a reduced chance in surgical error and the associated costs.~      Target Tape is a non invasive device that is in a grid format that is placed against the~     subject's skin. The grid pattern will then appear on the medical imaging scan. The medical~     practitioner can correlate device grid on the body to the medical scan image to make their~     incisions in more accurate locations.~   "
73575|NCT02603861|"~     This study will evaluate the effect of single doses of LY3154207 on the amount of time it~     takes for healthy sleep-deprived men to fall asleep. The study will also estimate how much~     LY3154207 gets into the blood stream and how long it takes the body to remove it. Information~     about any side effects that occur will be collected. Each participant will complete four~     study periods, which will last a total of about 8 weeks.~   "
73576|NCT02603848|"~     Morphine is now the most commonly used opioid in children for pain management even though the~     safety of morphine use in children is a primary concern for parents as it is perceived to~     have more associated risks. Ibuprofen and other Non-Steroidal Anti-Inflammatory Drugs~     (NSAIDs) have also been shown to be effective for the management of postoperative pain with~     fewer associated adverse effects. However, there have been concerns that utilization of~     ibuprofen alone may lead to inadequate pain management. Evidence of whether ibuprofen is~     equally effective as morphine for postoperative pain control in pediatric inguinal surgery is~     lacking and needs to be further explored as a measure to potentially reduce opioid exposure~     in children. To determine which drug is more effective for relieving post-operative pain,~     this trial will compare the effectiveness of ibuprofen and morphine at reducing~     post-operative pain, and the amount of analgesic use required post-surgery.~   "
73577|NCT02603835|"~     The primary objective of the study is to collect confirmatory data supporting the safety and~     effectiveness of SSO2 Therapy in treatment of anterior acute myocardial infarction (AMI)~     patients who have undergone successful percutaneous coronary intervention (PCI) with stenting~     within six hours of experiencing AMI symptoms.~   "
73578|NCT02603822|"~     The investigators' overall objective with this study is to determine performance~     characteristics of small intestine permeability measurement using 13C mannitol and 12C~     (regular) mannitol.~   "
73579|NCT02603809|"~     The main objective of the study is to explore the effects of ERA - at different dose~     strengths - on the efficacy, safety and tolerability in subjects with essential hypertension~   "
73581|NCT02603783|"~     Reflux is common, especially after large meals. In general, this can do no harm. However, if~     reflux occurs often and causes troublesome symptoms and or complications, it is called~     gastroesophageal reflux disease (GERD). Long exposure to gastric acid causes the mucosa of~     the esophagus to loose its integrity, which is thought to lead to the symptom of heartburn.~     Several food products can also impair the esophageal mucosa integrity and thereby influence~     reflux symptoms. One of these products is capsaicin, the pungent ingredient of red peppers.~     Use of capsaicin often leads to worsening of complaints in patients with GERD and can cause~     symptoms in healthy volunteers, possibly due to its effect on the mucosal integrity.~      In this study the investigators want to investigate the effect of capsaicin infusion on~     mucosal integrity. The investigators will evaluate mucosal impedance and the histology of the~     esophageal mucosa. In addition, the investigators also aim to assess the involvement of the~     TRPV1 receptor by evaluating the possible release of neuropeptides in the esophageal mucosa.~   "
73582|NCT02603770|"~     The objective of this study is to compare laboratory tests profiles of a botanic drug~     XueZhiKang (XZK) 300 mg capsules versus a marketed drug Lovastatin 20 mg tablets in healthy~     male volunteers between 18 and 50 years of age.~   "
73583|NCT02603757|"~     This is a pilot study to test whether there is an association between baseline Vitamin D~     levels, Vitamin D supplementation and survival in patients with stage III colon and stage~     II/III rectal cancer receiving chemotherapy. 70 patients with colon stage III or rectal stage~     II or III cancer that require chemotherapy will be screened and 60 patients will be enrolled.~     Patients will be randomized to standard dose (2000 IU daily) or high-dose (50,000 IU weekly)~     Vitamin D supplementation for 1 year after initiation of chemotherapy. Patients' Vitamin D~     levels will be checked throughout supplementation then followed for 5 years with occasional~     Vitamin D testing and surveying in order to collect information on recurrence and survival~     outcomes.~   "
73584|NCT02603744|"~     The goal of this study is to determine safety and tolerability and of intra-ovarian injection~     of adipose derived stromal cell in women with premature ovarian failure and to study the~     preliminary efficacy ADSCs intra ovarian injection on ovarian function improvement.~   "
73585|NCT02603731|"~     This project seeks to describe the incidence of delirium in the Intensive Care Unit (ICU) and~     to identify risk and preventive factors associated with development of delirium.~      Especially, the investigators want to investigate if an imitated natural light/dark cycle~     influences frequency of delirium.~   "
73586|NCT02603718|"~     The purpose of this study is to investigate the efficacy of a simple and easy to use tool~     that can extract relevant attention-related markers - Brain Engagement Index (BEI) from~     ongoing EEG. During standard rehabilitative physical therapy sessions.~   "
73587|NCT02603705|"~     The purpose of this study is to evaluate the safety and tolerability of Egalet-002 in~     opioid-experienced patients with moderate-to-severe chronic noncancer pain.~   "
73588|NCT02603692|"~     In this research study the investigators want to learn more about the quality of life before,~     during and after cancer treatment in patients with central nervous system brain tumors. Often~     CNS tumors and cancer treatment can cause many physical and emotional problems and side~     effects. Some of these problems and treatment side effects can cause a change in a patient's~     qualify of life and overall well-being. Quality of life questionnaires are used to measure~     well-being and ability to carry out daily activities by asking patients to answer several~     questions about their physical, emotional, and social well-being.~      In this research study we want to find out if patient's answers to these questions change~     over the course of your treatment. We also want to see if doctors and nurses can use these~     answers to the questions to help patients feel better and increase their activity during~     cancer treatment.~   "
73589|NCT02603679|"~     The purpose of this neoadjuvant trial is to evaluate efficacy and toxicity of chemotherapy~     using weekly paclitaxel (arm A) versus the combination of the cdk 4/6 inhibitor palbociclib~     and standard endocrine treatment (arm B). After 12 weeks treatment is switched crossover.~     During the 24-weekly treatment period, clinical and radiological evaluations are performed~     repeatedly. Switch between the treatment arms A and B is allowed in case of lack of response~     or due to toxicity. A translational subprotocol is a mandatory part of the study protocol,~     except for use of PET-CT evaluations. Postoperatively, patients receive three 3-weekly~     courses of chemotherapy with a combination of epirubicin and cyclophosphamide.~   "
73590|NCT02603666|"~     The aim of the study is to find CF patients at risk for cystic fibrosis related liver disease~     (CFLD). Comparison of ultrasound by two modalities and biochemical markers with histological~     evaluation of liver biopsy if present.~   "
73591|NCT02603653|"~     Cushing's disease is a state of chronic endogenous glucocorticoid excess. Cushing's disease~     is responsible for increased morbidity and mortality. Recent studies have pinpointed the~     frequency of somatic sequelas and persistent alteration in quality of life despite the cure~     of the disease. More specifically, a few studies have described persistent psychopathology,~     maladaptive personality and cognitive impairments in patients with a history of Cushing's~     disease. Among these, hippocampal memory deficits have been found in the majority of studies,~     a finding that is consistent with the alterations described in hippocampal neurons during~     chronic exposure to glucocorticoids. However, the tools currently available to assess~     hippocampal-dependent memory are multiple, sometimes difficult to perform by clinicians and~     to analyze or may lack of diagnostic sensitivity. The investigators have recently developed~     an original tool, the virtual radial task in 3D, which has shown to be reliable to detect~     subtle alterations in hippocampal-dependent memory in several human diseases. The primary aim~     of the study is the evaluation of persistent cognitive impairments (hippocampal memory) in~     patients cured of Cushing's disease for at least one year using the virtual radial task in 3D~     and to compare it with that obtained with classical cognitive tests.~   "
73611|NCT02603380|"~     This qualitative study aims to evaluate the usability of a smartphone application called~     DelApp. The study will assess usability and acceptability of the software app by asking 40~     clinicians to administer the DelApp assessment to consented patient and clinicians. Feedback~     will be collected through semi-structured interviews with the clinicians. The feedback will~     be used to optimise the software application in preparation for formal validations studies.~   "
75119|NCT02583672|"~     The purpose of this study is to measure levels of blood and brain chemicals related to~     oxidative stress and inflammation in healthy volunteers and individuals with Type 1 Gaucher~     disease (GD1) to see if these levels are altered by GD1.~   "
73592|NCT02603640|"~     Epilepsy is a major neurological disorder, affecting of the order of 0.5 to 1% of the~     population. It is a very invalidating disease, with high impact on quality of life. In a~     large proportion of cases, medication cannot prevent seizures; surgical removal of the~     regions responsible for seizures is then the only way to cure patients. However, results~     crucially depend on the correct delineation of the epileptogenic zone.~      In this context, computational modeling, under the form of a virtual brain is a powerful~     tool to investigate the impact of different configurations of the sources on the measures, in~     a well-controlled environment.~      In this project, the simulate in a biologically realistic way MEG (Magnetoencephalography)~     and EEG (Electroencephalography) fields produced by different configurations of brain~     sources, which will differ in terms of spatial and dynamic characteristics will be offered to~     participants. The research hypothesis is that computational and biophysical models can bring~     crucial information to clinically interpret the signals measured by MEG and EEG. In~     particular, the hypothesis can help to efficiently address some complementary questions faced~     by epileptologists when analyzing electrophysiological data.~      The strategy will be three-fold:~      i) Construct a virtual brain models with both dynamic aspects (reproducing both~     hyperexcitability and hypersynchronisation alterations observed in the epileptic brain) and a~     realistic geometry based on actual tractography measures performed in patients ii) Explore~     the parameter space though large-scale simulations of source configurations, using parallel~     computing implemented on a computer cluster.~      iii) Confront the results of these simulations to simultaneous recordings of EEG, MEG and~     intracerebral EEG (stereotactic EEG, stereoelectroencephalography (SEEG)). The models will be~     tuned on SEEG signals, and tested versus the surface signals in order to validate the ability~     of the models to represent real MEG and EEG signals.~      The project constitutes a translational effort from theoretical neuroscience and mathematics~     towards clinical investigation. A first output of the project will be a database of~     simulations, which will permit in a given situation to assess the number of configurations~     that could have given rise to the observed signals in EEG, MEG and SEEG. A second - and major~     - output of the project will be to give the clinician access to a software platform which~     will allow for testing possible configurations of hyperexcitable regions in a user-friendly~     way. Moreover, representative examples will be made available to the community through a~     website, which will permit its use in future studies aimed at confronting the results of~     different signal processing methods on the same 'ground truth' data.~   "
73593|NCT02603627|"~     This study will investigate the prevalence of chronic obstructive pulmonary disease (COPD) in~     patients who are newly diagnosed with lung cancer and compare it to the prevalence of COPD in~     controls recruited from a smoking cessation clinic.~   "
73594|NCT02603614|"~     CNDP-578-02 is a randomized, double-blind, placebo-controlled, dose-escalation, crossover~     design trial. Eight evaluable subjects (n=8) with chronic stable heart failure and moderate~     renal impairment will be randomized (1:1) to receive cenderitide or placebo. Enrolled~     subjects will begin with Infusion Period A where they will receive up to 7 days of~     continuous, subcutaneous, dose-escalating infusions of cenderitide or placebo via the Insulet~     Drug Delivery System. Enrolled subjects will then cross over into Infusion Period B where~     they will receive up to 7 days of continuous, subcutaneous, dose-escalating infusions of~     cenderitide or placebo.~   "
73595|NCT02603601|"~     This randomized controlled trial is designed to test the feasibility and efficacy of a novel~     10-week mindfulness-based intervention (MBI) on weight maintenance as well as behavioral and~     psychosocial outcomes in patients who have undergone bariatric surgery.~      Primary hypothesis:~      Bariatric patients who have stopped losing weight (< 5 lbs weight loss in past month) 1-5~     years post-surgery will be willing to participate in this 10-week intervention. The~     investigators expect a high adherence rate (>70%) and no issues with meeting recruitment~     goals.~      Secondary hypotheses:~      Patients assigned to the MBI will show greater improvement in a) weight control (defined by~     differences in body weight between baseline and follow-up); b) eating behaviors (binge~     eating, emotional eating); and c) psychosocial measures (quality of life, depression,~     perceived stress, eating self-efficacy, coping ability) than a standard lifestyle~     intervention (1 hr lifestyle counseling).~      Patients assigned to the MBI intervention will show greater improvement in biomarkers of~     stress and inflammation [salivary cortisol, high sensitivity C-reactive protein (hs-CRP),~     interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-alpha)] as compared with a~     standard lifestyle intervention.~      Food-related attentional bias as measured by the food-related Stroop task will be~     differentially affected among patients assigned to the MBI as compared with the intensive~     lifestyle intervention and standard lifestyle intervention.~   "
73596|NCT02603588|"~     Sphenopalatine ganglion (SPG)-acupuncture has been shown to exhibit distinct effects in~     treatment of nasal inflammatory disease, but the mechanisms remain largely unknown.~     Investigators aimed to assess the effects of SPG acupuncture for nasal ventilation function~     and autonomic nervous system in health volunteers. The randomized, double-blind, controlled~     clinical trial enrolled healthy volunteers.Healthy subjects were randomly assigned to either~     active SPG-acupuncture group or sham-acupuncture group. All subjects were assessed for~     self-reported nasal ventilation, nasal patency (nasal airway resistance (NAR) and nasal~     cavity volume (NVC)), exhaled nasal nitric oxide (nNO) before and after acupuncture.~     Meanwhile, in order to explore underlying mechanisms of SPG acupuncture, the changes in~     neuropeptides (substance P (SP), vasoactive intestinal peptide (VIP) and neuropeptide Y~     (NPY)) in nasal secretions were investigated at baseline, 30 minutes, 2 hours, and 24 hours~     after acupuncture.~   "
73597|NCT02603575|"~     Pneumocystis Pneumonia is increasing in Immunocompromised Non-HIV Infected Patients. The~     effects and safety of caspofungin and corticosteroids is not certain in this population. All~     Immunocompromised Non-HIV patients with respiratory failure were randomized into caspofungin~     and non-caspofungin group and corticosteroids and non-steroids group. The major outcome is 28~     day mortality, the second outcome are time of respiratory rate decreases to less than 25~     breath per minute, body temperature lower than 37.3℃.~   "
73598|NCT02603562|"~     The purpose of this study is to assess the safety and biological activity of ATYR1940 in~     patients with early onset facioscapulohumeral muscular dystrophy (FSHD).~   "
73599|NCT02603549|"~     Previous research has identified spontaneous cerebral spinal fluid leakage as a cause for~     spontaneous intracranial hypotension, leading to positional headache patterns. Typical~     magnetic resonance imaging findings include subdural fluid collections, enhancement of~     pachymenginges, engorgement of venous structures, pituitary hyperemia, and sagging of the~     brain (SEEPS). Because pituitary hyperemia has been documented in cases of spontaneous~     cerebral spinal fluid leakage and is known to mimic a pituitary tumor or hyperplasia, the~     investigators would like to like to assess the clinical manifestations and neuroimaging~     abnormalities of SIH patients with regard to the pituitary gland. Specifically, the~     investigators are looking to analyze the compression of the pituitary stalk and conduct a~     systemic evaluation of pituitary function in SIH patients.~   "
73635|NCT02603068|"~     This multicenter, randomized, open-label study will assess the safety and efficacy of oral~     treprostinil in subjects diagnosed with pulmonary hypertension associated with pulmonary~     fibrosis.~   "
75120|NCT02583659|"~     This prospective cohort study aims to observe the efficacy and safety of the first-line~     combined chemotherapy for advanced gastric cancer(AGC) in Chinese population.~   "
73600|NCT02603536|"~     WelTel Oak Tree is a repeated measures study that enrolled 85 HIV+ individuals from the Oak~     Tree Clinic at BC Women's Hospital. Participants were be provided with a cell phone and/or~     unlimited text messaging capability if they do not have it already, and for one year received~     a weekly text message stating How are you. Participant problems and non-responses were be~     followed up by a nurse. Data on demographics, CD4 counts, HIV viral loads, HIV medication~     adherence and attendance at appointments was collected for the year prior to the intervention~     and during the intervention for comparison. Data assessing quality of life was also collected~     at three points during the one year study period. Cost effectiveness and cost benefit of the~     intervention is being studied to assess feasibility of transferring the intervention to a~     programmatically funded facet of patient care.~   "
73601|NCT02603523|"~     The efficacy of exercise programs to prevent falls among older people is well documented in~     the literature. However, older people's adherence to these exercise programs has been~     reported to be suboptimal, varying between 21% and 74%. In addition, about 45% of people aged~     over 60 years do not meet the minimum recommended level of physical activity. In this~     context, dance is a promising alternative to traditional exercise programs, as it can~     positively influence important risk factors for falls, such as sedentary lifestyle, balance~     impairments and muscle weakness. Nevertheless, a recent systematic review conducted in this~     area show that the lack of randomized clinical trials as well as the low methodological~     quality of existing studies do not allow to reach definitive conclusions on the real effects~     of dance on risk factors for falls. A type of dance that is becoming popular among the older~     population in Brazil is the Senior Dance. Senior Dance classes consist of different~     choreographies, which include rhythmic and simple movements with rhythmic folk songs. The~     concentration required to learn the choreographies challenges balance, motor coordination and~     cognitive function. Thus the present study is a randomized clinical trial aiming to~     investigate the Senior Dance effect on balance, mobility and cognitive function, compared~     with a control group, among older people living in the community. A total of 82 subjects will~     be randomly allocated into two groups. The intervention group will participate in a 12-week,~     twice-weekly group-based program of Senior Dance, while the control will be encouraged to~     maintain their current routine activities. Outcomes measures (balance, mobility and cognitive~     function) will be evaluated before and after the intervention by an assessor blinded to group~     allocation. The results of this study will assist health practitioners when prescribing~     intervention for the older population.~   "
73602|NCT02603510|"~     Primary Objective:~        -  Assess the safety of SAR342434 and Humalog when used in external pumps.~      Secondary Objectives:~        -  Intervals for infusion set changes.~        -  Incidence of insulin pump alarms for infusion set occlusion.~        -  Patient observation of infusion set occlusion.~        -  Adverse events including bruising at the infusion site and injection site reactions.~   "
73603|NCT02603497|"~     The objective of this study is to compare the pharmacokinetics of ASP015K in patients with~     impaired renal function and subjects with normal renal function.~   "
73604|NCT02603471|"~     The proposed study, for HIV positive alcohol dependent adults currently taking naltrexone, is~     a pilot randomized controlled trial (RCT) examining the outcomes of a 12-week behavioral~     support program delivered via text-messaging.~      It is expected that the text messaging intervention will reduce alcohol use and HIV-risk~     behaviors. The investigators also hypothesize that the intervention will improve adherence to~     HIV treatment and naltrexone.~      To test the effects of the intervention on these target outcomes, 25 participants receiving~     the text messaging intervention will be compared to 25 participants receiving an~     informational pamphlet. The pamphlet will contain information about the importance of HIV~     treatment adherence, reducing HIV risk behaviors, and health consequences associated with~     alcohol use.~      By providing support to maximize HIV treatment regimen and naltrexone adherence, coupled with~     coping skills to promote abstinence from alcohol, the text messaging intervention may provide~     a promising, cost-effective, and easily deployable behavioral support program for alcohol~     users who are HIV-infected.~   "
73605|NCT02603458|"~     This study seeks to examine the effectiveness of NRX-1074 in the treatment of negative~     symptoms and cognition in schizophrenia compared to other agents at the glycine site which~     have demonstrated inconsistent results for negative symptoms. In addition to testing~     efficacy, we will examine the time course of response of symptoms as well as any effects on~     memory consolidation.~   "
73606|NCT02603445|"~     This is a phase Ib multi-center, open-label study: escalation part followed by expansion~     part. The primary purpose of the Phase Ib CBCL201X2102C study is to characterize the safety~     and tolerability of BCL201 combined with idelalisib in patients with FL and MCL.~      Approximately 65 patients are to be enrolled.~      The primary endpoint for the Phase Ib is frequency, severity and seriousness of AEs, lab~     abnormalities and other safety parameters such as ECG changes. An adaptive Bayesian logistic~     regression model (BLRM) will guide the dose escalation to determine the MTD/RDE in phase Ib.~     In addition Bayesian regression models will be used to estimate the dose-exposure~     relationships for both BCL201 and idelalisib in order to guide the escalation steps. A~     Bayesian method for the expansion part will be used for the primary activity objective.~      The study data will be analyzed and reported based on all patients' data of the escalation~     and expansion part.~   "
73607|NCT02603432|"~     The main purpose of this study is to compare maintenance treatment with avelumab plus best~     supportive care (BSC) with BSC alone, to determine if avelumab has an effect on survival in~     patients with locally advanced or metastatic urothelial cancer that did not worsen during or~     following completion of first-line chemotherapy.~   "
73608|NCT02603419|"~     This is a Phase 1b, open-label, multi-center study comprising a lead-in phase and an~     expansion phase. The lead-in phase is a multiple-dose, randomized, parallel-arm,~     pharmacokinetic and pharmacodynamic study of avelumab as a single agent in adult patients~     with cHL. Patients enrolled in the lead-in phase of this study are required to have relapsed~     following a prior autologous or allogeneic HSCT, or to be ineligible for HSCT. Based on the~     preliminary TO, safety, and efficacy results from the lead-in phase, the expansion phase will~     evaluate the anti-tumor activity and safety of single-agent avelumab utilizing an~     intra-patient dose escalation paradigm based on two of the dosing regimens studied in the~     lead-in phase in 40 cHL patients in whom an allogeneic HSCT has failed.~   "
73609|NCT02603406|"~     Neovascularization Induced by Mechanical Barrier disrUption and Systemic erythropoietin in~     patients with cerebral perfusion deficits (NIMBUS trial)~   "
73610|NCT02603393|"~     This study will evaluate the efficacy and safety of QVA149 (110/50 μg o.d.) vs tiotropium (18~     µg o.d.) + salmeterol/fluticasone propionate FDC (50/500 µg b.i.d.) in patients with moderate~     to severe COPD~   "
74226|NCT02595307|"~     To determine if providing a written document in addition to the standard oral discussion of~     surgical risks improves risk recall for the parents/guardians of a child seen in consultation~     for cleft palate surgery, and if this has any effect on overall satisfaction after the~     procedure~   "
73612|NCT02603367|"~     This pilot clinical trial studies the COMFORT (C-Communication, O-Orientation and~     opportunity, M-Mindful presence, F-Family, O-Openings, R-Relating, and T-Team) caregiver~     intervention in improving communication and reducing distress in caregivers of patients with~     lung cancer. Caregivers of patients with cancer may experience stress and anxiety due to~     difficulty communicating with family, friends, and healthcare providers, or feeling unable to~     communicate openly. A communication intervention that improves the caregiver's ability to~     communicate with patients and healthcare providers may help reduce caregivers' psychological~     distress and improve the health outcomes of patients.~   "
73613|NCT02603354|"~     The purpose of this clinical study was to evaluate, the effectiveness and sensitivity~     post-treatment of a 6% hydrogen peroxide with nitrogen-doped titanium dioxide light activated~     bleaching agent, the impact of shorter interval times on tooth sensitivity and to compare the~     efficacy with 2 different application protocols. This is a clinical randomized double-blind~     split-mouth study. 31 patients were treated with: one upper hemi arcade with one application~     of 36 minutes and the other hemi arcade with 3 applications of 12 minutes each with a 6%~     hydrogen peroxide. Two sessions were appointed with 48h of intervals between them. Tooth~     colour was registered by VITA Classical amd VITA Bleach guide by two blinded assessors in the~     beginning, immediately after each session. Tooth colour variation and sensitivity were~     compared between both application protocols~   "
73614|NCT02603341|"~     A pragmatic randomized clinical trial of patients with locally advanced breast cancer~     randomized to either proton or photon therapy and followed longitudinally for cardiovascular~     morbidity and mortality, health-related quality of life, and cancer control outcomes. Quality~     of life is the outcome measure for the estimated primary completion date of November, 2020,~     www.radcomp.org.~   "
73615|NCT02603328|"~     This phase I/II randomized, placebo-controlled, double-blinded, single-site clinical trial is~     designed to investigate the effect of a prolonged course of atorvastatin versus placebo on~     CCM lesional iron deposition assessed by validated quantitative susceptibility mapping (QSM)~     MRI studies in patients who suffered a symptomatic bleed within the preceding one year.~   "
73616|NCT02603315|"~     The purpose of this study is to To assess the correlation between the predictive factor of~     vascularity (CD74) in malignant pleural mesothelioma and treatment results (response rate,~     and overall survival) .~   "
73617|NCT02603302|"~     This is a one arm study where patients with locally advanced rectal cancer will receive~     neoadjuvant treatment with escalated dose radiotherapy (with 3D conformal radiotherapy, up to~     59,4 Gy) and radiosensitizing chemotherapy. Then, patients will operated (total mesorectal~     excision) after 8 weeks of interval. Primary endpoint will be pCR (pathologic complete~     response).~   "
73618|NCT02603289|"~     The purpose of this study is to demonstrate that changing aligners weekly provides similar~     results to changing aligners every two weeks.~   "
73619|NCT02603276|"~     A large body of evidence confirm the cholesterol lowering effect of phytosterols and red~     yeast rice. Because their mechanisms of action mime the ones of chemical statins and~     cholesterol absorption inhibitors, it is plausible that their association will provide a more~     relevant (and safe) LDL cholesterolemia reduction.~   "
73620|NCT02603263|"~     Encouraging individuals to eat fruit and vegetables is difficult. However, recent evidence~     suggests that using social-based information might help. For instance, it has been shown that~     if people think that others are eating lots of fruit and vegetables, that they will consume~     more food to match the 'norm'.The purpose of this study was to determine whether social norm~     messages could be used to enhance vegetable purchases in workplace restaurants, in an~     observational study.~   "
73621|NCT02603250|"~     The purpose of this study is to evaluate the use of a noninvasive Hb device (Pronto® with~     DCI-mini™ sensors) as an accurate method for measuring Hb levels among children between 6 and~     59 months against the standard reference hematology analyzer. The secondary purpose is to~     evaluate the accuracy of two HemoCue® Hb 201+ capillary blood collection methods against the~     standard reference hematology analyzer.~      The study hypothesizes that the Pronto® with DCI-mini™ sensor will approximate Hb values~     within ±1.0 g/dL and secondly, it will correctly classify participants as anemic or not~     anemic with less than 31% disagreement when compared to the standard reference hematology~     analyzer among children 6 to 59 months of age. Additionally, the two different HemoCue® Hb~     201+ capillary blood collection methodologies will both approximate Hb values within ±1.0~     g/dL and secondly, it will correctly classify participants as anemic or not anemic with less~     than 35% disagreement when compared to the standard reference hematology analyzer among~     children 6 to 59 months of age.~   "
73622|NCT02603237|"~     The study will compare plasma and urine post-prandial metabolomics after fat and glucose oral~     load according to lifestyle factors.~   "
73623|NCT02603224|"~     The primary objective of this study is to evaluate the safety and tolerability of the~     investigational drug, MRG-201, in healthy volunteers. MRG-201 is designed to mimic the~     activity of a molecule called miR-29 that decreases the expression of collagen and other~     proteins that are involved in scar formation. MRG-201 is being studied to determine if it can~     limit the formation of fibrous scar tissue in certain diseases.~      MRG-201 will be tested in healthy volunteers by injection into intact skin or adjacent to a~     short skin incision. Volunteers may receive one or several doses of MRG-201, and will be~     monitored for local reactions in the skin, signs or symptoms of adverse effects on the body,~     and for the levels of MRG-201 in the blood over time. Skin biopsies will also be collected to~     study how cells in the skin respond when exposed to MRG-201.~   "
73624|NCT02603211|"~     The aim of this study is to see how well a tactile imaging sensor will detect for breast~     masses compared to traditional mammography and/or ultrasound. This device may allow a simple,~     convenient method to screen for breast tumors. This data will be used to check the~     feasibility of using the device to detect breast tumors.~   "
73636|NCT02603055|"~     Hepatitis E is characteristic by sporadic and local epidemic around the world, and mainly~     infects adults aged 15 to 40 years old, resulting in the infection rate ranged from 1% to~     15%. The investigational hepatitis E vaccine is a recombinant aluminium-adjuvant hepatitis E~     vaccine.~      This is a single center, randomized, blinding, parallel-controlled phase Ib clinical trial.~     This study will determine the safety and immunogenicity of the investigational recombinant~     hepatitis E vaccine in healthy adults between 16 and 65 years.~   "
73625|NCT02603198|"~     Dental treatments, particularly third molars extraction, can become extremely uncomfortable~     and painful. They are associated to anxiety, fear and many other unpleasant sensations.~     During surgery, patients can present cardiorespiratory repercussions of these sensations.~     This fact generally justifies the employment of methods of monitoring and appliance of safer~     therapeutic alternatives. Local anesthetics are the most frequently drugs used in dentistry.~     Vasoconstrictors, particularly epinephrine, are important components of anesthetic solutions~     to increased time for anesthetic absorption and consequently increasing the duration of~     anesthesia. The use of smaller amounts of anesthetic solution can reduce the risk of systemic~     toxicity, however decrease the total surgical time. It is well known that the amount of~     epinephrine injected into patients during anesthetic procedures can produce adverse~     hemodynamic effects. Levonordefrin was adding to dental cartridges promising to reduce~     cardiac stimulation due it less β activity, and maintain the same clinical and systemic~     effects. But some studies for maxillary or intraosseous infiltrations showed no difference in~     heart rate and any anesthetic success over epinephrine. Thus, this study aims to compare the~     clinical efficacy and safety of anesthetic mepivacaine 2% with epinephrine 1:100,000 or~     1:20,000 levonordefrin employing a clinical trial model of third molars extractions in~     healthy adults.~   "
73626|NCT02603185|"~     This phase I study designed in 3 parts is a randomized, placebo-controlled, sequential~     ascending-dose study of healthy volunteers. The safety, tolerability and pharmacokinetics of~     ascending single and multiple dose of Hemay007 will be assessed in Part 1 and Part 3,~     respectively. Food effect following a single oral dose will be evaluated in Part 2.~   "
73627|NCT02603172|"~     GSK3039294 has been developed in order to offer an orally available alternative to parenteral~     CPHPC (GSK2315698 [metabolite of GSK3039294]) for plasma serum amyloid P component (SAP)~     depletion prior to use of anti SAP monoclonal antibody (mAb) in the treatment of systemic~     amyloidosis. This phase 1 study is intended to study safety, tolerability and pharmacokinetic~     (PK) profile of GSK3039294 in humans. This study consists of three parts. Part A will~     evaluate safety and tolerability of single doses of GSK3039294 in healthy subjects, Part B~     will evaluate safety and tolerability of repeat doses of GSK3039294 in healthy subjects, and~     Part C will evaluate safety and tolerability of repeat doses of GSK3039294 in subjects with~     systemic amyloidosis. Part A is a single dose, open label, dose escalation study. Two cohorts~     of subjects will be enrolled to provide data from 6 subjects per cohort and up to 4 different~     doses (2 dose levels per cohort) of GSK3039294 will be tested. For Cohorts 1 and 2, each~     subject may take part in two dosing periods. Part B is repeat dose, open label, dose~     escalation study. Sufficient number of subjects will be enrolled in Cohort 3a to ensure 6~     completers (Cohort 3b will be conducted if required) and GSK3039294 will be administered~     repeatedly for a total of 21 days. Each subject will take part in a single study period. In~     Part C a single dose level of GSK3039294 will be tested for 21 days repeat dose, in 12~     subjects with systemic amyloidosis. Each subject will take part in a single study period. The~     total duration for Part A is approximately 8 weeks, Part B is approximately 8-9 weeks, and~     Part C is approximately 13 weeks.~   "
73628|NCT02603159|"~     Definitive chemoradiotherapy with cisplatin with cisplatin plus 5-fluorouracil is the~     standard in Western countries in esophagus cancer.But in China because of its toxic reaction,~     most of patients stop the halfway.Because low toxicity, Capecitabine is widely used in the~     chemotherapy of esophageal cancer.~      The purpose of this experiment was to study the different cycle on capecitabine with~     chemotherapy for esophageal cancer chemoradiation effect.We are prepared to within 2 years~     study recruited 200 patients with esophageal cancer.The primary endpoint is overall survival~     and the secondary endpoints include progression-free survival, response rate,pathologic~     complete response rate and adverse events.~   "
73629|NCT02603146|"~     The purpose of this study is to determine if hydroxychloroquine (HCQ) is safe and effective~     for the prevention of future onset of rheumatoid arthritis (RA) in individuals who have~     elevations of an autoantibody, anti-cyclic citrullinated peptide (anti-CCP).~      The following recruitment strategies will be employed towards identifying healthy subjects~     with elevated anti-cyclic citrullinated peptide 3 (anti-CCP3) levels:~      -Pre-screening:~        -  first degree relatives of patients with RA;~        -  subjects at health-fairs; and~        -  identification of subjects with elevated anti-CCP3 levels in the absence of inflammatory~          arthritis in rheumatology clinics.~   "
73630|NCT02603133|"~     Resilience means a healthcare provider's ability to cope, recover, and learn from stressful~     events, as well as their access to resources that promote health and well-being. Neonatal~     intensive care unit (NICU) health professionals' need to have particularly good resilience,~     because their work is extremely stressful and their patients, fragile preterm infants,~     require their undivided attention. The investigators propose a feasible and engaging~     intervention to enhance resilience among NICU health professionals promoting their ability to~     provide safe care.~   "
73631|NCT02603120|"~     This study will evaluate the efficacy of switching from a regimen of dolutegravir (DTG) and~     abacavir/lamivudine (ABC/3TC) or a fixed dose combination (FDC) of~     abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) to a FDC of~     bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing DTG and ABC/3TC~     as the FDC ABC/DTG/3TC in virologically suppressed HIV-1 infected adults.~   "
73632|NCT02603107|"~     This study will evaluate the safety and efficacy of switching to a fixed dose combination~     (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing on a~     regimen consisting of boosted atazanavir (ATV) or darunavir (DRV) plus either~     emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC) in~     HIV-1 infected adults who are virologically suppressed.~   "
73633|NCT02603094|"~     Fasting (according to ASA, ESA or institutional guidelines) is an important strategy to~     minimize the risk of regurgitation, vomiting and pulmonary aspiration during general~     anaesthesia; the effect of fasting time for clear fluid on gastric pH in children is goal of~     this study and can be investigated in children undergoing elective procedures in general~     anaesthesia and intubation without inconvenience or additional invasive procedure and hence~     without additional risk~      Hypotheses: Gastric pH is higher in children that drink clear fluids until premedication~     before anaesthesia induction than in those that drink until 2 hours before anaesthesia~     induction~   "
73634|NCT02603081|"~     This study will evaluate the safety and efficacy of three dose levels of SPI-1005 compared to~     placebo on vertigo, tinnitus and sensorineural hearing loss in 40 adults with Meniere's~     disease.~   "
73638|NCT02603029|"~     Objective of the study is to determine the influence of the cream with Silver fir wood (Abies~     alba) extract (Belinal) on the skin parameters and functions in comparison to the placebo~     cream. 10 healthy female subjects will use the test cream on one half and placebo cream on~     the other half of the face and of the gluteal part twice a day for 12 weeks. Various face~     skin parameters will be evaluated before the cream use (the baseline), after 6 and after 12~     weeks of the cream use. To evaluate the photoprotective potential of Belinal the minimal~     erythema dose (MED) will be determined before (the baseline) and after 12 weeks of the cream~     use at the gluteal area.~   "
73639|NCT02603016|"~     This study evaluates the efficacy of clinical nutrition to treat lung neoplasms and breast~     carcinoma.We estimate there will be 480 patients accepted.120 patients will receive GLSE~     compound,120 patients will recrive Maitake mushroom extract compound,120 patients will~     recrive Rinseng compound,and 120 patients will be as blank countrol group.Efficacy Study of~     Clinical Nutrition to Treat Lung Neoplasms And Breast Carcinoma~   "
73640|NCT02603003|"~     Metastasis is the leading cause of death in patients with lung cancer, and circulating tumor~     cells(CTCs) play a key role in the process of distant metastasis. The investigators' study~     will elaborate the clinical significance of CTCs intervented by Traditional Chinese~     Medicine(TCM) in lung cancer from the diagnosis and clinical staging,metastasis and~     recurrence, individual treatment and prognosis and so on, in order to provide a new direction~     for the treatment of lung cancer.~   "
73641|NCT02602990|"~     A non-interventional multicentric study for patients with a cerebral AVM for which~     endovascular treatment is indicated.~   "
73642|NCT02602977|"~     In a wide range of auto-inflammatory and infectious diseases attenuation of the immune~     response could be beneficial. Remote ischemic preconditioning (RIPC) has been identified as a~     means of protecting patients undergoing cardiac surgery from perioperative myocardial~     ischemic damage. This protection can be divided in a `first window of protection` directly~     after preconditioning and a `second window` that protects patients 12-48 hour after~     preconditioning. Repeated RIPC might have additional value, possibly by combining beneficial~     effects of the first and second windows of protection. The mechanisms behind these effects~     are under investigation, but attenuation of the inflammatory response is a major candidate.~     However, this has not yet been demonstrated in the setting of systemic inflammation in humans~     in vivo. This study aims to investigate the effects of (repeated) ischemic preconditioning on~     inflammation during human endotoxemia.~   "
73643|NCT02602964|"~     Live kidney transplantation is first choice for patients with end-stage kidney disease.~     Therefore, the safety and well-being of kidneys donors are highly important objectives in~     live kidney donation. Low pressure pneumoperitoneum can decrease postoperative pain and~     therefore also concomitant use of opioids.~   "
73644|NCT02602951|"~     The dynamic angio-MR sequences with injection of contrast (CE ARM) allow the study of the~     vascular anatomy. These sequences, widely used in clinical routine have shown their utility,~     in particular in the detection of the cerebrovascular diseases. The 4D flow MR sequences~     allow to quantify arterial parameters such as the speed of the circulating flow. By allowing~     an anatomical analysis and a functional analysis of quantitative parameters, 4D flow MR~     sequences could replace 1/ the currently used dynamic MRA sequences that are less precise in~     term of spatial and temporal resolution; 2/ the invasive exploration by DSA for the detection~     of vascular lesion and complete the exploration of the cervico-encephalic vascular~     pathologies by providing hemodynamical measures not yet accessible in clinical settings.~      In this context, the aim of the study is to evaluate the feasibility and the clinical~     usefulness of this 4D Flow technique to image brain vascular disorders including steno~     occlusive disorders. The evaluation will include several steps: 1/ optimization of~     acquisition parameters for the cranio-cervical arteries; 2/ comparison of two strategies for~     the post-processing 3/ feasibility for imaging of brain vascular disorders.~   "
73645|NCT02602938|"~     The purpose of this study is to determine whether Aspirin could affect the number and subtype~     of circulating tumor cells of metastatic breast cancer and colorectal cancer.~   "
73646|NCT02602925|"~     Rationale/hypothesis: Moderate-to-severe psoriasis can be treated with biologics.~      Objective To investigate whether the dose of biologics can be reduced in patients with~     psoriasis with stable disease.~      Study design: A pragmatic, multicentre, randomized, controlled, non-inferiority study with~     cost-effectiveness analysis.~      Study population: Patients with disease remission using normal dose of biologics.~      Intervention: 120 patients will be randomized into two groups: (1) dose reduction and (2)~     normal dose.~      Main study parameters/endpoints: The primary outcome is clinical effectiveness. Secondary~     outcomes are: health-related quality of life (HRQoL), number and time to disease flares,~     costs, health status, anti-drug antibody formation and serious adverse events~   "
73647|NCT02602912|"~     The main purpose of the study is to assess the feasibility and clinical performance of~     impedance based tissue identification in various spine structures.~   "
73648|NCT02602899|"~     Evaluate the long-term clinical effectiveness and safety of the PINS Deep Brain Stimulation~     to patients with refractory epilepsy.~   "
73649|NCT02602886|"~     The purpose of this research study is to evaluate whether Exposure and Response Prevention~     Therapy (ERP) can help adults with obsessive-compulsive disorder (OCD) in China following a~     training of professionals and ongoing consultation.~   "
73667|NCT02602639|"~     Currently, those with spinal cord injury (SCI) demonstrate increased prevalence of obesity~     (75%) cardiovascular disease (30 - 50%), type II diabetes (21%) and osteoporosis in the legs~     (100%) when compared to the general population. It is important to identify the modes and~     intensities of exercise most likely to generate a reduction in these inactivity-related~     diseases in this population.~      Therefore, the main purpose of this pilot research project is to implement and test a form of~     a spinal cord injury-specific exercise, known as FES rowing (FES: functional electrical~     stimulation).~   "
73668|NCT02602626|"~     The purpose of this study is to determine if women would find it acceptable to receive the~     HPV vaccine postpartum at the pediatrician's office at the time of their child's two-month~     well- child visit when offered during the third trimester of pregnancy.~   "
73669|NCT02602613|"~     A multi center study to evaluate the safety of the AMENDTM Mitral Valve Repair System and its~     ability to reduce mitral regurgitation. AMEND device is an annuloplasty ring implanted in a~     minimally invasive trans-catheter method.~   "
73650|NCT02602873|"~     Tacrolimus is recommended to be the first line therapeutic medication within the several~     immunosuppressive agents when treating refractory pediatric nephrotic syndrome, because of~     its definite efficacy and low toxicity. But there are still some key problems which hinder~     the using of tacrolimus in clinic, such as its narrow therapeutic widow, great individual~     difference of pharmacokinetics. Routine therapeutic drug monitoring(TDM) is needed in~     practice. But the disadvantage of TDM is hysteresis, which could lead to treatment failure or~     toxicity. To find out the reasons of great pharmacokinetic difference between patients and~     find out the individual proper dosage before administration are important for the clinical~     using of tacrolimus.~      It is hot in research of tacrolimus in organ transplant field, such as the association~     between gene polymorphisms of cytochrome P-450 3A4, 3A5 and multiple drug resistant~     gene(MDR1) and concentration of tacrolimus. However, there is few study about~     pharmacogenomics and metabonomics of tacrolimus in patients of nephrotic syndrome.~      The aim is to study the relationships between pharmacogenomics, metabonomics of tacrolimus~     and its efficacy, toxicity and blood concentration in patients of nephrotic syndrome, to find~     out the exact dosage before administration, to provide reference to individual drug~     administration.~   "
73651|NCT02602860|"~     This study will estimate how fast two antiepileptic drugs (Levetiracetam and Brivaracetam)~     enter the human brain. Brain imaging will be used to measure how quickly the radioactive~     probe [11C]UCB-J exits the brain when Levetiracetam or Brivaracetam are given. This will be~     used to estimate how fast the antiepileptic drugs enter the brain.~   "
73652|NCT02602847|"~     The aim of this study is to validate in the context of liver transplantation, the interest of~     the cccDNA assay technique developed by the team of Professor Zoulim (INSERM U1052) on liver~     biopsy and correlate this assay cccDNA in hepatitis B virus (HBV) viral load and serum liver~     through several groups of patients at transplantation (on graft and native liver explant) and~     after transplantation.~   "
73653|NCT02602834|"~     High intensity Interval training (HIT) has repeatedly been documented to have superior~     positive effects on oxygen uptake and general physical health compared to continuous moderate~     exercise in healthy individuals and patients with heart disease. Recently, the same effect~     has been shown in heart transplanted recipients. Which mechanisms that explains this~     difference is uncertain; the effect can be due to changes in the heart or changes in the~     peripheral tissue and muscles. To explore these mechanisms the investigators will in this~     study compare two different exercise modalities, and explore how different biomarkers change~     in blood, related to exercise.~   "
73654|NCT02602808|"~     It is important to identify patients with acute pancreatitis who are at risk for developing~     persistent organ failure early in the course of disease. The investigators evaluated whether~     peripheral blood non-coding RNAs, including microRNAs and long noncoding RNA (lncRNA), could~     serve as a good marker for detection of acute pancreatitis with persistent organ failure at~     early phase.~   "
73655|NCT02602795|"~     Before starting treatment with XR-NTX, a medication that blocks the positive effects of~     opioids and helps people stay off opioids, individuals who are dependent on opioids first~     have to endure a difficult withdrawal process. This study aims to develop and test an~     intervention to help people who are opioid dependent successfully complete that transition;~     the investigators will also develop and test a comparison condition aimed at reducing HIV~     risk behavior.~   "
73656|NCT02602782|"~     The purpose of the study is to collect physiologic data streams with the Accuryn Monitoring~     System and validate the accuracy of these measurements against existing gold standards, and~     to track and analyze changes in these physiologic data streams to identify clinical~     signatures that may enable earlier diagnosis and intervention of critical conditions.~   "
73657|NCT02602769|"~     Rapid onset Obesity, Hypoventilation, Hypothalamic dysfunction and Autonomic Dysregulation~     (ROHHAD) is a syndrome named in 2007. The hallmark of the syndrome is the rapid onset obesity~     and dysregulation of central ventilation. There is little information about the metabolic~     changes that lead to the rapid onset obesity in these children. The investigators would like~     to study the metabolic phenotype of these children to understand the disturbances in energy~     balance that lead to the rapid onset obesity.~   "
73658|NCT02602756|"~     Ocular melanomas have been treated for a long time by enucleation, with an unfavorable major~     impact on the patient's quality of life, social life, self-image, how they feel about others~     and about living with this disability. As a matter of fact, classical radiation therapy by~     photons is not accurate enough to deliver a sufficiently high dose to eradicate a melanoma~     without causing irreversible ocular brain complications since these tumors are  relatively~     radio resistant . The possibility of delivering high doses due to the precision of protons~     (Bragg peak) has allowed to overcome this limitation. The conservative uveal melanoma~     treatment has become a standard after the Collaborative Ocular Melanoma Study (COMS)~     indicating an equivalent rate of metastases and a non-impaired survival rate with a~     conservative treatment when compared to immediate enucleation. The quality of life benefits~     due to a conservative treatment has been demonstrated. Protontherapy dose has been defined in~     an empirical manner, it is probably excessive even if it applies to radio-resistant tumors.~     In France, radiotherapy by protons for choroidal melanomas delivers a dose of 60 Gy cobalt~     equivalent (that is 52 measured Gy, or  Physical dose) in 4 fractions and 4 days.~      Referential treatment of ocular melanomas (other than conjunctiva) indicates proton-therapy~     for T1, T2, T3 < 40% of ocular volume, and T4 only if extra scleral extension ≤ 2mm. However,~     there is an enucleation indication for T3 > 40% of ocular volume and T4.~      Our purpose is to override this relative contraindication, choroidal melanoma volume ≥ 40% of~     ocular volume. As a matter of fact, the investigators observe an increasing demand from~     ophthalmologists and patients for not performing primary enucleation. Also, during the last~     five years treatment of complications have improved and a less  hard  hypo fractionation~     (6.5 Gy per fraction) has equivalent local control results as for  hard  fractionation (13~     Gy per fraction).~   "
73670|NCT02602600|"~     The aim of the present study is to evaluate the effect of treatment with Liraglutide on the~     coronary microvasculature and angina symptoms, in overweight patients with microvascular~     dysfunction and angina pectoris but no coronary artery stenosis.~   "
73671|NCT02602587|"~     Dendrogenin A is present in mammals normal tissues and fluids, notably blood. It is~     down-represented or absent in cancer cell lines and tumors. In the opposite, OCDO is~     accumulated in cancerous conditions and virtually absent of normal tissues. This study will~     try to determine modulations of these oxysterols and protein involved in their metabolism~     between Acute myeloid leukemia (AML) patient samples and normal blood or marrow, for~     evaluation of these markers as companion biomarkers for Dendrogenin A treatment.~   "
73672|NCT02602574|"~     Post endoscopic pancreatitis (PEP) has different initial immunologic response to primary~     injury compared to acute pancreatitis of other etiology (non-PEP AP).~      The purpose of this study is to compare initial immunologic response, 24 h after primary~     injury, in patients with PEP and patients with acute pancreatitis of other etiology.~   "
73659|NCT02602743|"~     Ketamine and propofol have been used most frequently agents and remifentanil is used with~     increasing frequency in recent years. Investigators will compare ketamine-propofol and~     ketamine-remifentanyl effects on drug consumption, respiration, hemodynamics and recovery in~     pediatric colonoscopy patients. Our study is a prospective, randomized comparison of~     ketamine-propofol and remifentanyl-propofol for sedation in pediatric patients during~     elective colonoscopy. ASA I-II, 2-16 years old, seventy children will be included in the~     study after ethics committee approval and written informed consent from the parents. Children~     with cardiovascular, cerebral, pulmonary, renal and hepatic diseases will be excluded from~     the study. Group I (RK); 2 mg/kg ketamine and 0,25 µg/kg remifentanyl will be administered~     for induction in 1 minute.Then 0,1 µg/kg/h remifentanyl infusion will be started.~      Group II (PK); 2 mg/kg ketamine and 1 mg/kg propofol will be administered for induction and~     then 1 mg/kg/h propofol infusion will be started. In case of movement, crying, heart rate and~     systolic blood pressure more than 20% increase from baseline; 0.05 to 0.1 mg / kg of~     remifentanil will be administered in group I, 0.5-1 mg / kg will be administered propofol in~     group II. Not enough that case 0.5-1 mg / kg of ketamine will be applied.~      The anesthesiologist will continue monitoring after completion of colonoscopy until recovery~     of full consciousness. A Steward recovery score of 7 will be defined as the end of the~     recovery time.~   "
73660|NCT02602730|"~     This project developed and evaluated an Internet-based interactive program with digital~     coaching designed to assist two groups of smokers in quitting smoking: (1) pregnant smokers~     and (2) general-population smokers (i.e., men and non-pregnant women). Program content was~     based on the U.S. Department of Health and Human Services Clinical Practice Guidelines,~     Treating Tobacco Use and Dependence: 2008 Update (Fiore et al., 2008) and input from~     project consultants.~   "
73661|NCT02602717|"~     Cytological examination of punctured lymph nodes is the gold standard for confirming~     metastatic lymph node spread of differentiated thyroid cancers. In order to increase the~     diagnostic sensitivity of fine-needle cyto-punctured lymph nodes, an assessment of Tg levels~     of the aspirate could be included. Although this technique has been well proven, many~     uncertainties remain, especially with regards to a pathological cut-off value and its~     clinical utility when the thyroid is still intact. This uncertainty is mainly due to~     discordancy between low Tg levels found in cytopunctured lymph nodes with normal cytology,~     and their final histopathological analyses.~      To eliminate this uncertainty, cyto-punction will be performed intra-operatively after~     localizing and isolating the target lymph nodes for assessment of cytology and Tg values. The~     thyroid gland might be present or absent (already operated) depending on the case. Finally,~     the cyto-punctured lymph nodes will be excised for complete histopathological analysis. In~     order to determine whether the Tg values are appropriate in cases where the thyroid is~     intact, a control group has been included (First operation for thyroid cancer or benign~     pathology). To eliminate the possible iatrogenic risks of lymph node dissection and resection~     in patients for whom it is not indicated, only lymph nodes found along the incision path for~     neuromonitoring of the recurrent laryngeal nerve (performed systematically) will be analysed~     and excised.~   "
73662|NCT02602704|"~     -  The purpose of this study is to study the effectiveness of bazedoxifene in preventing~          loss of bone mineral density (BMD) and trabecular bone score (TBS), and any fractures in~          postmenopausal rheumatoid arthritis (RA) patients receiving long-term GCs.~        -  This is a randomized, controlled, open-label extension study for 48 or 56 weeks. At~          study entry, all patients will receive elemental calcium (1200 mg daily) and vitamin D~          (800 IU daily) and will be randomized by blocks of two to receive either bazedoxifene~          (20 mg/day) or none.~   "
73663|NCT02602691|"~     Transplant rejection is one of the most important complications of heart transplantation and~     requires a specific monitoring, including regular and invasive endomyocardial biopsies.~      The average hospital cost of a biopsy has been estimated at 3 297 dollars in United States.~     In France, the reimbursement rates by the Health Insurance for the corresponding stays vary~     from 682 to 25 865 euros, according to the finding of a rejection and its severity.~      AlloMap® is a non-invasive blood test that can identify patients with low probability of~     moderate to severe acute cell transplant rejection. The non-inferiority of the use of the~     AlloMap® test has been demonstrated in comparison of the usual care in terms of diagnosis of~     acute cellular rejection in a randomized study conducted in the United States. Following this~     study, the ISHLT (International Society of Heart and Lung Transplantation) made~     recommendations advocating its use for these patients between 6 months and 5 years after~     heart transplantation. This new test could be an alternative to systematic biopsies usually~     performed to patients whose allograft function is stable, but it is very expensive since the~     analysis of a blood sample cost 2 000 euros pre-tax in France. This cost has to be compared~     with the current patient care. By replacing biopsies performed systematically, the test~     should reduce the costs of full and day hospitalizations for the realization of biopsies but~     also the costs associated with their possible complications. In addition, it can be expected~     that its use provides a benefit to the patient in terms of quality of life. Indeed, the~     achievement of a biopsy may cause significant stress and anxiety for the patient, due to~     discomfort, pain and potential complications that may be severe.~      To this day, no medico-economic assessment has been conducted to prove the interest of the~     use of AlloMap® compared to systematic realization of endomyocardial biopsies. The purpose of~     the CUPIDON study is to assess the effectiveness of the use of the AlloMap® test for~     monitoring heart transplant patients in the context of usual care and in accordance with~     international recommendations. AlloMap® will be used and compared to the current surveillance~     strategy by endomyocardial biopsies from 6 months to 36 months after heart transplantation.~     The investigators hypothesize that the use of this test for the diagnosis of acute cellular~     transplant rejection would avoid the costs of a large number of biopsies, while increasing~     the quality of life of patients related to their health.~   "
73664|NCT02602678|"~     Acute viral bronchiolitis is the first cause of respiratory distress in infant. Airway~     inflammation increases the respiratory system resistances and dynamic hyperinflation. This~     leads to an increase in the work of breathing. In Chronic obstructive pulmonary disease~     patients as in neonates, prone position (PP) improves lung function and decreases the end~     expiratory lung volume. The investigators hypothesized that in infants with severe~     bronchiolitis, prone position reduces the intrinsic Positive End Expiratory Pressure (PEEPi)~     and the work of breathing (WOB). The investigator designed a prospective randomized crossover~     study with 16 infants younger than six months who need ventilatory support by nasal~     continuous positive airway pressure (nCPAP) for severe acute viral bronchiolitis. Work of~     breathing (product time pressure) and PEEPi will be estimated using an esophageal pressure~     probe in prone and supine position.~   "
73665|NCT02602665|"~     This is a single center, randomized, controlled trial in which tunneled central line~     catheters will be placed in two distinct, select positions. The catheter tip position will~     then be followed up prospectively after placement to determine whether there is any~     malpositioning of the tip and if one placement is better than the other.~   "
73666|NCT02602652|"~     The objective of this study is to measured the Geometric mean titer (GMT) of Japanese~     Encephalitis neutralizing antibody and proportion of seroprotection among the children who~     received a booster dose of JE-CV after the first dose of SA14-14-2 vaccine.~   "
73673|NCT02602561|"~     The anterior cruciate ligament (ACL) is a primary stabilizer of the knee, and thus when ACL~     injury occurs participation in physical activity is compromised. Reconstructive surgery is~     often necessary to repair the damage which is then followed by a regimen of physical therapy~     in order to regain full activity. Nutritional intervention after the surgery could help the~     patient maintain muscle mass during recovery, thus allowing for a quicker return to normal~     activity.~   "
73674|NCT02602548|"~     This study will describe the time point at which a positive culture from a patient who has~     undergone shoulder surgery should be treated as an infection versus a false positive result~     that should be disregarded. Intraoperative biopsies will be taken and cultured from 50~     subjects who have undergone an open surgical procedure and 50 from subjects undergoing an~     arthroscopic procedure.~   "
73675|NCT02602535|"~     The central aim of this study is to test the efficacy of Mindfulness-Oriented Recovery~     Enhancement (MORE), an intervention designed to disrupt the risk chain leading from chronic~     pain to prescription opioid misuse and addiction. The investigators plan to conduct a full~     scale clinical trial to determine whether MORE (relative to a support group control~     condition) can reduce symptoms of chronic pain and opioid misuse among patients who are~     receiving pain management in primary care via long-term opioid analgesic therapy.~   "
73676|NCT02602522|"~     This trial aims to compare the effect of Danshen-Jiang-Fu Granule prepared by Danshen (Salvia~     Miltiorrhiza) from different producing areas (Shandong and Sichuan) for the relief of primary~     dysmenorrhea.~   "
73677|NCT02602509|"~     The purpose of this study is to evaluate the bactericidal activity against Mycobacterium~     tuberculosis of celecoxib in combination with established drugs used to treat tuberculosis~     (TB). Pharmacokinetics (PK) and whole blood bactericidal activity (WBA) will be measured in~     healthy volunteers following administration of the study drugs alone and in combination.~   "
73678|NCT02602496|"~     This study evaluates the impact of increased intake of fruits and vegetables and whole grains~     on markers of inflammation and gut microbial composition. The treatment groups are 3 servings~     of whole grain per day; 5 servings of fruits and vegetables per day; a combined 3 servings of~     whole grain per day and 5 servings of fruits and vegetables per day; and a control (3~     servings of refined grains per day provided).~   "
73679|NCT02602483|"~     The objetive of this study is to explore the efficacy and safety of a triple combination of~     ibuprofen, magnesium and ascorbic acid for acute pain treatment in TMJD patients~   "
73680|NCT02602470|"~     To survey patients with rosacea about their rosacea treatment preferences as well as to~     assess potential drivers of rosacea treatment satisfaction.~   "
73681|NCT02602457|"~     Atrial fibrillation is the most common heart rhythm disorder. The management of atrial~     fibrillation is of great importance. Despite the presence of exercise intolerance, weight~     gain, and an associated decline in overall health and well-being in patients living with~     atrial fibrillation, recommended standard care does not currently include the prescription of~     exercise to address these significant health issues. Exercise training is a recognized form~     of treatment of persons with heart disease. An exercise program such as high-intensity~     interval training when compared to moderate-intensity continuous exercise training may~     provide a stronger training stimulus for exercise and clinical outcomes; may be more~     efficient and motivating; and, may help to improve adherence to exercise training in~     persistent or permanent atrial fibrillation patients. This has been shown in patients with~     coronary artery disease and heart failure.~      The primary objectives of this prospective study are to examine the impact of high-intensity~     interval training compared to moderate-intensity continuous exercise training in adults with~     persistent or permanent atrial fibrillation on exercise capacity and quality of life.~   "
73682|NCT02602444|"~     The purpose of the PINPOINT study is to compare pharmacokinetics (PK) and pharmacodynamics~     (PD) of ticagrelor in ST-elevation myocardial infarction (STEMI) and non-ST-elevation~     myocardial infarction (NSTEMI) patients designated to invasive strategy. Data regarding~     comparison of PK and antiplatelet action of ticagrelor in STEMI and NSTEMI are sparse.~     Recommended dosing regimens of ticagrelor are identical for both STEMI and NSTEMI, although~     it is not known whether PK and PD features of ticagrelor are uniform in these patients.~   "
73683|NCT02602431|"~     Third molars extraction is a surgery frequently performed in dentistry. It is generally~     associated to a great postoperative distress rendered by pain, swelling and trismus, caused~     by surgical trauma inflammation. Several methods have been proposed to prevent these~     complications and to increase tissue repair quality. The use of low level laser therapy~     (LLLT) has been reported in dentistry since 1970. A large number of studies have reported the~     benefits of LLLT without collateral damage, positive effect as an anti-inflammatory agent and~     benefits in accelerating wound repair. However, some clinical applications strategies have~     been contradictories in everyday practice with results not always equivalent.~      Objective: To verify if a single LLLT intra or extra oral application, singly, are analogous~     in their effects in controlling postoperative edema, trismus, pain and wound repair in third~     molar surgery.~   "
73684|NCT02602418|"~     Despite potent combination antiretroviral therapy, cognitive (memory and concentration)~     problems continue to occur in up to 50% of HIV-infected individuals, especially in older~     infected individuals, and those who abuse alcohol, marijuana or psychostimulants. Since no~     effective treatments are available to these individuals with cognitive problems, conservative~     estimates indicate that the cost of care for these patients could double in the next two~     decades. To address this urgent problem, this study will use a comprehensive approach~     (cognitive tests, functional MRI and several biomarkers) to evaluate whether a novel~     computer-based training program would improve the brain function, especially working memory~     and attention, in HIV-infected and infected individuals.~   "
73717|NCT02601976|"~     Hepatitis C is a global problem, prevalent in developed as well as in the developing~     countries. New treatment regimens using PegInterferon in combination with ribavirin has led~     to improved sustained viral response rates for some genotypes. A single arm, open labeled,~     multicentre trial was conducted to evaluate the response rate and safety of PegInterferon~     alfa-2a (Unipeg®) plus ribavirin (Ribazole®) for the treatment of patients with chronic~     hepatitis C infection. RVR at 4 weeks, ETR at 24 weeks for genotype 3 and at 48 weeks for~     genotype 1 patients and SVR was determined at 24 weeks after completion of treatment. Quality~     of life at baseline and at follow-up visits were determined using SF-36.~   "
73685|NCT02602405|"~     In Norway an estimated 10 % of the population is injured annually. Of these 36.000 sustain~     permanent functional impairment, 1.200 receive disability pension, and approximately 2.500~     die because of their injuries. Mortality is the most common variable measuring trauma~     outcome. However, measuring only trauma mortality may be looking merely at the tip of the~     iceberg. For every trauma death, there are ten-folds suffering long term functional~     impairment. Mortality is therefore a too crude variable to describe the impact of injuries -~     both for the individual trauma patient and for society as a whole. There is a need for~     variables describing long-term outcomes on a functional level. The aim of this study is to~     use the rate of return to work and education as an alternative outcome measure. The ability~     of returning to work after injury is a central indicator of individual functional outcome,~     combining both physical and mental skills in performing complex and compound tasks. Previous~     studies on return to work after injury are limited by a combination of short follow-up times,~     the use of patient reported outcomes and having mainly been focusing on only severely injured~     patients (ISS > 15). This a population-based study including all patients in working age (16~     - 65 years) received by a trauma team in any of the eight hospitals within the region of~     Central Norway in the time period from June 1st,2007 to May 30th, 2010. Already collected~     trauma registry data will be linked with national register data on sickness and disability~     benefits, employment and education.~   "
73686|NCT02602392|"~     The potential benefits of this research to public health include improved understanding of~     cultural factors in pediatric asthma self-management, improved self-management skills for~     children, and better asthma management skills for their parents. This could result in eased~     suffering and improved quality of life for millions of children and their families, and also~     reduce the economic burden borne by society in the forms of medical expenditures and lost~     productivity.~   "
73687|NCT02602379|"~     Contrary to immobility and, to a lesser extent, to the hypnosis/unconsciousness component~     of general anaesthesia, the monitoring of analgesia remains largely elusive, evaluated~     mainly through poorly sensitive and potentially undesirable changes in patients' vital signs.~     This has led the industry to pursue the development of various devices and indices based on~     other physiological parameters such as heart rate variability (HRV), electroencephalogram~     (EEG), skin conductance, to name only a few. To the best of the knowledge, none of these~     parameters on its own has shown sufficient capacity in detecting different degrees of~     pain/analgesia balance to gain wide clinical use.~      The purpose of this prospective observational study is to evaluate the response of a~     single-parameter index (the Analgesia Nociception Index [ANI]) and a multi-parameter index~     (the Nociception Level [NoL] Index) when patients under combined general anaesthesia/epidural~     anaesthesia for laparotomies are subjected to a standardized painful stimulus (a tetanic~     stimulation over the ulnar nerve at 70 mA, 100 Hz for 30 seconds) at different doses of~     remifentanil infusion at steady state (0,005 mcg/kg/min; 0,05 mcg/kg/min; 0,1 mcg/kg/min;~     0,15 mcg/kg/min). With the painful stimulus held constant but the analgesia provided~     gradually increased, it is expected to characterize the response of these two indices to~     different levels of nociception/anti-nociception balance.~   "
73688|NCT02602366|"~     The purpose of The Quatro Study is to assess the acceptability, preferences, user experience~     and effect on sexual behavior of four different vaginal microbicide or multi-purpose~     technology (MPT) delivery forms, using placebo products in 18-30 year old African women:~     rapidly disintegrating vaginal insert, intravaginal ring (IVR), film and gel. The study also~     examines adherence to the dosage forms through objective markers, developed for each dosage~     form prior to the commencement of the study.~   "
73689|NCT02602353|"~     The purpose of this study is to evaluate the analgesic efficacy and safety of a new pain~     patch compared to placebo and no treatment in subjects experiencing Delayed Onset Muscle~     Soreness (DOMS).~   "
73690|NCT02602340|"~     This project aims to identify brain and behavioral characteristics of individuals~     experiencing symptoms of depression that will predict the effectiveness of Behavioral~     Activation Therapy. Brain imaging aspects of the study will use functional magnetic resonance~     imaging (fMRI) and electroencephalography (EEG). Behavioral assessments will include~     self-report questionnaires, computer-based and observational tasks, and interviews.~     Assessments will focus on how individuals process positive information (such as reward) and~     negative information (such as distressing images), as well as how people make decisions.~     These assessments will be conducted across 2-3 in-person sessions prior to beginning the~     treatment, and will be repeated across 2-3 in-person sessions after completing treatment. A~     blood draw will also be conducted pre- and post- treatment. Behavior Activation therapy will~     consist of 10, 90-minute weekly therapy sessions conducted in small groups.~   "
73691|NCT02602327|"~     This is a phase I dose escalation study (3+3 design) with a dose expansion arm (12 patients)~     designed to evaluate safety of the combination of Tas-102 and radioembolization using~     Yttrium-90 (90Y) resin microspheres for patients with chemotherapy-refractory liver-dominant~     chemotherapy-refractory metastatic colorectal cancer (mCRC).~   "
73692|NCT02602314|"~     The study will investigate in newly diagnosed CP-CML patients the efficacy of NIL frontline~     therapy vs IM followed by switch to NIL in the case of absence of optimal response as defined~     by the ELN criteria.~   "
73693|NCT02602301|"~     Objective: To evaluate the relationship between intravenous (IV) infusion of oxytocin using~     either saline 0.9% or glucose 5% & neonatal Bilirubin & sodium level.~      Study Design: A randomized case - controlled study. Setting: The Obstetrics and Gynecology~     casuality department of Kasr El Aini hospital (Cairo University - Egypt)~   "
73716|NCT02601989|"~     The aim is to continue our program on PDE5 inhibition by evaluating effects on insulin~     resistance, including glucose metabolism and subclinical inflammation, after a 6-week~     administration of tadalafil in T2D patients. The primary objective is to study the effect of~     tadalafil compared with placebo on insulin sensitivity during a euglycemic hyperinsulinemic~     clamp.~      This is a double-blind, placebo-controlled crossover study with one study site. Twenty-five~     T2D patients will be recruited and randomized to per oral intake of tadalafil 20 mg o.d. for~     six weeks and after a wash-out period of eight weeks intake of placebo for another six weeks,~     or vice versa. At the end of each 6 week treatment period a glucose clamp, subcutaneous~     needle biopsies as well as muscle and subcutaneous microdialysis will be performed.~     Endothelial function tests and arginin stimulation of insulin secretion tests will be~     performed after 3 weeks in each treatment arm.~   "
73694|NCT02602288|"~     The purpose of this randomized controlled trial is to develop and test the efficacy of a~     multilevel, multimodal intervention designed to reduce children's exposure to secondhand~     tobacco smoke (primary outcome) and promote smoking cessation in mothers (secondary outcome).~     Low-income mothers who smoke and their children will be enrolled from the supplemental~     nutrition program, Women, Infants and Children (WIC) clinics. All mothers visiting WIC~     clinics will receive a clinic-level intervention, which consists of nutrition counselors~     following an ask, advise, and refer protocol to identify children exposed to secondhand~     tobacco smoke, advise mothers who smoke about the harms of such exposure and the benefits of~     reducing exposure, and referring mothers to the trial. Screened eligible mothers will be~     consented and randomized to an attention control condition focused on nutrition (CTL) or to~     an experimental (EXP) multimodal behavioral intervention that integrates telebased counseling~     to promote reduction of child secondhand smoke exposure (SHSE) and maternal smoking with an~     adjunct smoking cessation mobile app and nicotine replacement therapy use. The investigators~     will test the primary hypothesis that relative to children in the CTL condition, those in the~     EXP condition will have lower exposure SHSE as measured by mothers' reports and child~     cotinine levels. The investigators will also test the secondary hypothesis that relative to~     mothers in the CTL condition, those in the EXP condition will have higher bioverified 7-day~     point prevalence quit rates. In addition, the study will: (a) evaluate if specific~     psychosocial and behavioral factors-- social support, urge coping skills, self-efficacy, and~     SHSe protective behaviors--mediate the effects of the EXP intervention on outcomes and (b)~     explore whether other residential smokers, level of nicotine dependence, depressive/anxious~     symptoms, weight concerns, intervention dosage, and pregnancy status predict outcomes and~     moderate treatment effects.~   "
73695|NCT02602275|"~     The purpose of this study is to explore the effect of Neurexan® on the brain response when~     participants undergo an emotional stressful condition in verum compared to placebo.~   "
73696|NCT02602262|"~     HIV-infected (HIV+) individuals who agree to accept and receive a solid organ transplant from~     an HIV+ deceased donor will be followed to determine the safety and efficacy of this~     practice. Some HIV+ individuals who receive a solid organ transplant from HIV-uninfected~     (HIV-) donors will also be followed.~   "
73697|NCT02602249|"~     In this study, safety and effects of MUC1-gene-DC-CTL and MUC1-peptide-DC-CTL on human~     gastric cancer are going to be investigated.~   "
73698|NCT02602236|"~     The study evaluates the efficacy of a new 2-piece appliance in patients with colostomy.~   "
73699|NCT02602223|"~     The purpose of this study is to examine if a biologically active commercially available~     amnion chorion membrane (ACM) is as effective as the commercially available inert dense~     polytetrafluoroethylene membrane (D-PTFE) in preserving jaw bone dimensions and whether it~     provides the added benefit of reducing post-operative discomfort after dental surgery~   "
73700|NCT02602210|"~     The main goal of the study is to investigate the clinical relevance, efficacy and safety of~     treating hypotensive cirrhotic patients with suspicion of sepsis and on vasopressors with~     low-dose hydrocortisone in order to reverse hemodynamic instability and organ failure and to~     decrease mortality.~   "
73701|NCT02602197|"~     The investigators conducted a prospective, randomized, double blind study to compare the~     effectiveness of intravenous paracetamol and dexketoprofen for preventing pain during first~     24 hours postoperative period in adult patient undergoing septoplasty.~   "
73702|NCT02602184|"~     This clinical study will be a prospective, placebo-controlled, double-blind, randomized and~     centrally evaluated intra-individual comparative study to assess the safety and efficacy of~     AR/101 concomitantly administered with Standard of Care (SoC) in accelerating re~     epithelialization of split thickness wounds compared with placebo and concomitantly with SoC,~     in the pannus of volunteers undergoing elective abdominoplasty.~   "
73703|NCT02602171|"~     The present study has the evaluation of a test to measure the localization performance goal .~     It is about the perception of danger audio signals in everyday listening environments nearby~     which are reproduced in controlled laboratory conditions. In addition, a dereverberation~     algorithm regarding speech intelligibility and localization ability is evaluated . The~     research hypothesis is that the dereverberation of the audio signals can improve speech~     intelligibility for both normal hearing and hearing-impaired persons. In addition, the~     binaural dereverberation algorithm should not affect the localization ability in everyday~     situations.~   "
73704|NCT02602158|"~     13C breath tests represent an attractive alternative in the measurement of gastric emptying~     (GE). Therefore these tests have been used in a variety of clinical settings such as in the~     assessment of gastroparesis, delayed GE in diabetic patients or in the assessment of GE with~     fat containing enteral formulas in critically ill patients.~      The investigators have previously demonstrated that the 13C sodium octanoate breath test~     (OBT) is an inappropriate measurement method for the GE of fat. The OBT appears to be~     affected by 1) post gastric processing of the OCC marker and 2) its interaction with the~     physical form and concentration of the fat present in the stomach and duodenum.~      The13C trioctanoate breath test (TriOBT) represents an attractive alternative to the OBT.~     Compared to OCC which is a medium chain fatty acid the 13C trioctanoate (TriOCC) is a~     triglyceride. TriOCC has similar physio chemical properties as the nutritional lipid e.g.~     rapeseed oil.~      This study aims to assess the efficacy of the TriOBT as a GE measurement method of fat in an~     acid stable lipid emulsion (LE1). The breath test results from the TriOBT will be compared~     with the OBT and further validated against gastric fat volume emptying data observed from~     MRI. The interim analysis will determine whether the study will proceed to stage 2 which will~     assess the efficacy of the TriOBT in an acid unstable lipid emulsion (LE4).~   "
73705|NCT02602145|"~     Angioplasty and stenting for atherosclerotic occlusive disease in the arteries supplying the~     legs (Peripheral Arterial Disease, PAD) is the most common endovascular procedure outside of~     the heart, but carries the highest rate of reconstruction failure. The underlying reasons for~     these poor results are not completely clear, but the main arterial segment within the leg,~     the femoropopliteal artery, appears to be significantly different from other peripheral~     arteries because the Superficial Femoral Artery (SFA) and Popliteal Artery (PA) that comprise~     the femoropopliteal artery segment, undergo large deformations during flexion of the limb. In~     our NIH application we propose to accurately measure these deformations using human cadavers~     and build mathematical models of human femoropopliteal arteries repaired with several~     frequently used PAD stents. These mathematical models would be able to assess the mechanical~     stress in the stented SFA and PA associated with limb flexion and predict disease recurrence~     for arteries with different patient and lesion characteristics. Results of model predictions~     will be validated in patients with PAD stents who have received these stents as part of their~     standard of care.~   "
73747|NCT02601573|"~     This is a randomized, multi-site, open-label trial of the co-administration of a fixed-dose~     combination (FDC) of EBR 50 mg + GZR (100 mg) (EBR/GZR) and SOF 400 mg, with and without RBV,~     in treatment-naïve (TN) and treatment-experienced (TE) participants with chronic HCV GT3~     infection with compensated cirrhosis.~   "
73706|NCT02602132|"~     The study will be conducted at University Hospital Alcorcón Foundation, belonging to the~     public network of hospitals of Madrid Health Service.~      The aim of this study is to evaluate the effects of clamping the urethral catheter prior to~     removal and determine which of the two options (clamping or free drainage) is the most~     recommended for removal of bladder catheterization in adults.~      The interest of this study is given by the importance of proper handling of catheterization~     in the health of patients admitted to a hospital and are subjected to this technique.~     Increase its interest the need for implementation of evidence-based care, and limited~     scientific literature on the subject.~      The study population will be patients undergoing short-term urethral catheterization at the~     Internal Medicine Service in the University Hospital Alcorcón Foundation.~      The methodology of the study is experimental, randomized clinical trial without drug type.~     Interventions (prior clamped and free drainage) will be assigned in a randomized manner.~      Interventions and data collection of patients who met the inclusion criteria to join the~     study will be conducted during 2016 and the first quarter of 2017. It is planned to present~     results at the end of 2017.~      Keywords: BLADDER TRAINING, INDWELLING CATHETER, URINARY CATHETER, URETHRAL CATHETER,~     CLAMPING, REMOVAL, ACUTE URINARY RETENTION.~   "
73707|NCT02602119|"~     The primary end-point of the study is to determine the sensitivity of OTL in identifying lung~     nodules when excited by an imaging probe. Investigators intend to enroll 50 lung cancer~     patients in this study. The study is focusing on patients presenting with suspected~     malignancies of the lung and pleura who are considered to be good surgical candidates.~   "
73708|NCT02602106|"~     Aquatic activities is one of the most attractive physical exercise during pregnancy,~     especially during the third trimester.~   "
73709|NCT02602093|"~     Rationale: Lumbosacral radicular syndrome (LSRS) is caused by a herniated lumbar nucleus~     pulposus (HNP) and the estimated annual incidence in The Netherlands ranges between 60,000 to~     75,000 people. Open microdiscectomy is the standard surgical technique.~      In recent years, several surgical techniques have been developed including, percutaneous~     transforaminal endoscopic discectomy (PTED). While PTED is gaining popularity in The~     Netherlands, evidence of its effects is lacking, leading to a heated debate. The current~     position of Zorginstituut Nederland (ZiN) is that there is insufficient evidence to support~     its use; therefore, PTED is not financially covered. The consequence is, patients are forced~     to pay the costs of treatment themselves. This study is expected to provide the necessary~     data to answer the question regarding effects and costs of PTED vs. open microdiscectomy, and~     help resolve the current debate.~   "
73710|NCT02602080|"~     Nausea after surgery may negatively influence patient satisfaction, may delay discharge, and~     cause unexpected hospital admissions. The trend toward ambulatory surgery has increased the~     focus on postoperative nausea, but published evidence is not based on standardized criteria~     for assessment. Therefore, the results for postoperative nausea are very diverse, especially~     reports on nausea incidence after regional anesthesia, i.e. spinal anesthesia. When~     peripheral nerve blocks have been applied for postoperative pain control, they significantly~     reduce postoperative pain, opioid consumption and side effects; patients receiving general~     anesthesia (GA) and nerve blocks are thought likely to have less nausea than patients~     receiving GA alone. This study is a pilot study looking at the incidence and intensity of~     nausea after orthopedic surgery under nerve blocks in foot and ankle (FA) patients and under~     nerve blocks with either sedation or GA in total shoulder arthroplasty (TSA) patients. The~     results of this study will help power a future randomized controlled trial, comparing the~     incidence and intensity of nausea in FA patients receiving GA through laryngeal mask airway~     (LMA) versus spinal anesthesia.~   "
73711|NCT02602067|"~     Tenatumomab is a Sigma-Tau developed new anti-Tenascin antibody. It is a murine monoclonal~     antibody directed towards Tenascin-C. By means of this antibody, Tenascin-C expression was~     studied on a commercial tissue array slides each carrying malignant breast, colorectal, lung,~     ovarian or B and T cell Non-Hodgkin Limphoma tissue sections. All these cancers type showed~     positivity to Tenascin-C between the 64% and 13.3%. Consequently, Sigma-tau is exploring the~     use of the 131I-labeled Tenatumomab for anti-cancer radioimmunotherapy.~   "
73712|NCT02602054|"~     The decision to treat patent ductus arteriosus in preterm infants, varies from a~     conservative, medical or immediate surgical treatment; although, at present, there is some~     controversy about this decision. This study aims to determine the efficacy and safety of~     surgical versus pharmacological treatment of patent ductus arteriosus in preterm infants.~   "
73713|NCT02602041|"~     The investigators will perform a pilot study to gain insight into attitudes, barriers and~     facilitators for health behavior change in cancer patients and their partners. Results of~     this pilot will be used to design suitable questionnaires to investigate health behavior~     change in a larger cohort of patients and their partners. It will also direct future~     interventions to adequately target patients and, potentially, their partners to improve their~     lifestyle following a cancer diagnosis.~   "
73714|NCT02602028|"~     It was aimed to examine the efficacy and safety of once daily dosage schema of colchicine in~     pediatric patients with FMF compared to twice daily dosage schema.~      In this 24-week, multicentric, randomized, controlled, noninferiority trial, pediatric~     patients newly diagnosed with FMF, carrying homozygote or compound heterozygote mutation and~     did not receive any treatment, were included. Patients were randomly assigned using block~     randomization method to receive treatment with once or twice daily doses. Clinical and~     laboratory characteristics and medication side effects were recorded and compared between~     groups. The study complied with Good Clinical Practice and the Consolidated Standards for~     Reporting of Trials (CONSORT) statement.~   "
73715|NCT02602002|"~     This was a single centre, randomised, double blind, placebo controlled, two-way cross-over~     design study to assess the feasibility of pain PD tests and to determine the variability and~     effects of a known analgesic drug (the opioid remifentanil) in South Korean healthy~     volunteers.~   "
73718|NCT02601963|"~     The purpose of this study is to see if the study drug, FMX-103, is safe to give and if it~     helps people with moderate-to-severe papulopustular rosacea.~      The investigational product is FMX-103 minocycline foam. Two concentrations of the~     investigational product, 1.5% and 3%, will be studied along with vehicle. The foam will be~     applied once daily to the face for the 12-week treatment duration of the study.~      Approximately 210 patients will participate in this study.~   "
73719|NCT02601950|"~     This is a Phase II, multicenter, open-label, single arm, 2-stage study of tazemetostat 800 mg~     BID administered orally in continuous 28 day cycles. Screening of subjects to determine~     eligibility for the study will be performed within 21 days of the first planned dose of~     tazemetostat. Eligible subjects will be enrolled into one of fivecohorts based on tumor type:~        -  Cohort 1 (Closed for enrollment): MRT, RTK, ATRT, or selected tumors with rhabdoid~          features, including small cell carcinoma of the ovary hypercalcemic type [SCCOHT], also~          known as malignant rhaboid tumor of the ovary [MRTO]~        -  Cohort 2 (Closed for enrollment): Relapsed or refractory synovial sarcoma with SS18-SSX~          rearrangement~        -  Cohort 3 (Closed for enrollment): Other INI1 negative tumors or any solid tumor with an~          EZH2 gain of function (GOF) mutation, including: epithelioid malignant peripheral nerve~          sheath tumor (EMPNST), extraskeletal myxoid chondrosarcoma (EMC), myoepithelial~          carcinoma, other INI1-negative malignant tumors with Sponsor approval (e.g.,~          dedifferentiated chordoma) any solid tumor with an EZH2 GOF mutation including but not~          limited to Ewing's sarcoma and melanoma~        -  Cohort 4 (Closed for enrollment): Renal medullary carcinoma (RMC)~        -  Cohort 5 (Closed for enrollment): Epithelioid sarcoma (ES)~        -  Cohort 6 (Opened for enrollment): Epithelioid sarcoma (ES) undergoing mandatory tumor~          biopsy~        -  Cohort 7 (Opened for enrollment): Poorly differentiated chordoma (or other chordoma with~          Sponsor approval)~      Treatment with tazemetostat will continue until disease progression, unacceptable toxicity or~     withdrawal of consent, or termination of the study. Response assessment will be evaluated~     after 8 weeks of treatment and then every 8 weeks thereafter while on study.~   "
73720|NCT02601937|"~     This is a Phase I, open-label, dose escalation and dose expansion study with a BID oral dose~     of tazemetostat. Subjects will be screened for eligibility within 14 days of the planned~     first dose of tazemetostat. A treatment cycle will be 28 days. Response assessment will be~     evaluated after 8 weeks of treatment and subsequently every 8 weeks while on study.~      The study has two parts: Dose Escalation and Dose Expansion.~      Dose escalation for subjects with the following relapsed/refractory malignancies:~        -  Rhabdoid tumors:~        -  Atypical teratoid rhabdoid tumor (ATRT)~        -  Malignant rhabdoid tumor (MRT)~        -  Rhabdoid tumor of kidney (RTK)~        -  Selected tumors with rhabdoid features~        -  INI1-negative tumors:~        -  Epithelioid sarcoma~        -  Epithelioid malignant peripheral nerve sheath tumor~        -  Extraskeletal myxoid chondrosarcoma~        -  Myoepithelial carcinoma~        -  Renal medullary carcinoma~        -  Other INI1-negative malignant tumors (e.g., dedifferentiated chordoma) (with Sponsor~          approval)~        -  Synovial Sarcoma with a SS18-SSX rearrangement~      Dose Expansion at the MTD or the RP2D~        -  Cohort 1 - ATRT~        -  Cohort 2 - MRT/RTK/selected tumors with rhabdoid features~        -  Cohort 3 - INI-negative tumors:~             -  Epithelioid sarcoma~             -  Epithelioid malignant peripheral nerve sheath tumor~             -  Extraskeletal myxoid chondrosarcoma~             -  Myoepithelial carcinoma~             -  Renal medullary carcinoma~             -  Chordoma (poorly differentiated or de-differentiated)~             -  Other INI1-negative malignant tumors (e.g., dedifferentiated chordoma) with Sponsor~               approval~        -  Cohort 4 - Tumor types eligible for Cohorts 1 through 3 or synovial sarcoma with~          SS18-SSX rearrangement~   "
73721|NCT02601924|"~     Eighty patients with inclusion criteria will participate in this studyEach patient will~     receive an injection in one of the following groups according to the random number table:~        1. Group TPMB: Topical pressure and massage with an Inferior alveolar nerve block (IANB)~        2. Group TGB: Topical gel of 20% Benzocain (Master-Dent, Monroe, NC) with IANB~        3. Group TPMI: Topical pressure and massage with a maxillary anterior infiltration (MAI)~        4. Group TGI: Topical gel with a MAI. Immediately after the injection, patients will be~          asked to record the amount of pain they felt during needle penetration and injection~          using VAS form.Data will be analyzed using ANOVA and t-test.~   "
73722|NCT02601911|"~     The aim of this study is effect of premedication on success of inferior alveolar nerve block~     injection. Sixty healthy adult volunteers including criteria, are participating. The patients~     will be divided into 3 groups and will be randomly given one of premedications including 1)~     10 mg Ketorolac, 2) 10 mg Ketorolac plus 1000mg Acetaminophen, and 3)Placebo, 45 minutes~     before applying the injection. All patients will receive standard Inferior Alveolar Nerve~     Block injection . Patients with no lip numbness and positive responses to cold and electric~     pulp tests would be excluded from the study. Endodontic access preparation will be initiated~     15 minutes after Inferior Alveolar Nerve Block injection. Pain during treatment will be~     recorded using a Heft parker Visual Analog Scale(VAS). Success will be considered as no or~     mild pain (VAS≤54) during caries/dentin removal, access cavity preparation and working~     lengths measurements. Data will be analysed using Mann-U-Whitney and Kruskal-wallis tests.~   "
73723|NCT02601898|"~     The aim of this study was to compare the therapeutic efficacy of lipoic acid versus~     progesterone by vaginal administration on subchorionic hematoma resorption in women at the~     first trimester of pregnancy with threatened miscarriage.~   "
73724|NCT02601885|"~     This study seeks to evaluate the safety, tolerability, pharmacokinetics (PK) and~     immunogenicity of ABT-555 in participants with relapsing forms of multiple sclerosis (RFMS).~   "
73725|NCT02601859|"~     The project is designed to generate critical information to design and justify a robust trial~     on lithium prevention of the onset of Alzheimer's disease (AD). Lithium exerts and inhibitory~     effect on Glycogen synthase kinase 3 (GSK-3) a brain biomarker of neuroprotection. The study~     consists of 3 phases:~        1. Phase 1 investigates rats to establish a reliable method to measure brain biomarker~          activity levels from blood biomarker activity.~        2. Phase 2 will determine whether the GSK3 enzyme activity is significantly different in~          subjects with MCI compared to normal individuals.~        3. Phase 3 investigates patients with MCI taking lithium to establish the minimum lithium~          dose required to inhibit the activity of GSK-3.~   "
73748|NCT02601560|"~     This is a Phase 2a randomized, double-blind (subject/investigator blinded, MedImmune~     unblinded), placebo-controlled, dose-escalation study to evaluate the safety, PK/PD, and~     immunogenicity of single IV and SC MEDI6012 doses in adult subjects with stable CAD.~   "
73749|NCT02601547|"~     Positron emission tomography (PET) with 18-fluoro-deoxy-glucose (PET-FDG) is emerging as a~     promising approach for detecting brain lesions in dementia, among which Alzheimer's disease~     has been the most widely studied.~   "
73726|NCT02601846|"~     A multicentre multinational prospective management outcome study has recently proven the~     safety of a diagnostic strategy combining clinical probability assessment with an~     age-adjusted D-dimer cut-off, defined as a value of (age x 10) in patients > 50 years, for~     ruling out PE in outpatients, with a very low likelihood of subsequent symptomatic VTE.~     Moreover, this study showed that such a strategy increased the diagnostic yield of D-dimers,~     as it allowed ruling out PE without further investigation in a significantly higher~     proportion of patients than when using standard cut-off, particularly so in patients 75 years~     or older.~      The objective of the present study is to confirm in a prospective cohort of real life~     patients the usefulness of the age-adjusted D-dimer cut-off to rule out PE in patients~     presenting to the emergency department with suspected PE.~   "
73727|NCT02601833|"~     The purpose of this study is to compare standard fillings and silver diamine fluoride (SDF)~     for treatment of cavities in baby teeth. The investigators will compare the effectiveness of~     stopping the cavity, cost of the treatments and the opinions of the families and the dental~     providers.~   "
73728|NCT02601820|"~     The PROP UP research study is funded by The Patient Centered Outcomes Research Institute~     (PCORI). PROP UP is a multi-centered prospective observational study that will evaluate~     all-oral treatment regimens for HCV regarding several patient-reported outcomes (PROs) such~     as HCV-associated symptoms, treatment side effects, medication adherence, out of pocket~     costs, comorbid conditions, and long-term benefits of cure and harms of treatment to compare~     PROs of different treatment regimens, treatment durations, and patient subgroups.~     Participants will be recruited from 9 U.S. liver centers. Approximately 1920 patients with~     HCV infection who are prescribed a regimen containing Harvoni®, Viekera Pak®, Zepatier®,~     DAC/SOF or SOF/VEL for chronic HCV will be recruited and approximately 1600 patients who are~     approved and begin HCV treatment will be enrolled in the longitudinal study. PRO surveys will~     be evaluated before, during and after HCV treatment.~      PROP UP is a collaborative effort between behavioral and biomedical researchers, a patient~     engagement group and a patient advocacy organization.~   "
73729|NCT02601807|"~     The ActiPatch is a cutaneous device which is CE marked approved for relief of pain. It is~     taped over the affected area and stimulation at a high frequency is reported to alleviate~     pain with no sensation. However there is no class 1 evidence for this on back pain. By~     randomising patients between application of an active device or a dummy device and assessment~     of disability and pain scores at two weeks, the efficacy or otherwise can be established. Low~     back pain is a major health problem and if effective this has major economic implications as~     the device is cheap and safe.~   "
73730|NCT02601794|"~     The investigators are conducting a web-based study to explore the use of a mindfulness app to~     improve quality of life among women with breast cancer.~      Eligible participants will be asked to provide informed consent to participate and submit a~     data authorization form to obtain information from the app at the end of the project.~      This 12-week project will randomly assign participants to one of two groups:~      Group 1 (AMT) will receive the mindfulness app right away; Group 2 (WC) will receive the~     mindfulness app at the end of 12 weeks.~      All participants will receive a welcome email with group designation. Participants assigned~     to Group 1 (AMT) will also receive app download instructions and pass code. Group 1 will be~     asked to complete the app's first 10-minute mindfulness exercise, at minimum.~      Participants assigned to Group 2 (WC) will be notified that they will receive app download~     instructions and pass code at the end of 12 weeks.~      Regardless of group assignment, all participants will be asked to complete web-based survey~     assessments 4 different times throughout the study (baseline, week 5, week 9, 12-week follow~     up). The surveys will be related to quality of life, mindfulness, mobile technology, health~     literacy, and chronic pain.~      To encourage participation, a member of the study team will send out weekly check-in emails.~      Once all data has been collected, app developers will provide the investigators with app data~     for each participant, including times accessed, length of time using app. This information~     will help the investigators observe which app characteristics are most useful, as well as the~     optimal amount of time needed to obtain benefit from the app.~      The investigators goals are to understand how using the mindfulness app compares to not using~     the mindfulness app. The investigators will also observe whether the app contributes to~     participants' quality of life. The investigators also want to understand more about how women~     use health apps overall. This information may inform issues related to delivery of app-based~     health interventions among women with breast cancer.~   "
73731|NCT02601781|"~     BVS STEMI STRATEGY-IT is a spontaneous, prospective, non-randomized, single-arm multicenter~     registry on consecutive STEMI patients eligible to undergo primary percutaneous coronary~     intervention (PPCI) with BVS implantation on the basis of the pre-specified inclusion and~     exclusion criteria.~      This registry has the objective to assess the immediate (peri-procedural and 30 days), mid (6~     months and 1 year) and long-term (3 and 5 years) results following BVS implantation using a~     pre-specified implantation strategy during PPCI in STEMI subjects.~   "
73732|NCT02601768|"~     The aim of this study is to determine whether three-dimensional tranesophageal~     echocardiography (3D TEE) assessment of ostium secundum atrial septal defect (ASD II) may be~     as efficient as two-dimensional (2D) TEE assessment complemented by the balloon-sizing during~     transcatheter closure of the defect.~   "
73733|NCT02601755|"~     Chronic pain in adolescents and young adults (AYA, aged 15-25) is a common problem. Pain that~     is not treated properly can reduce quality of life. Programs to help AYA learn to live with~     and manage pain are very important. Our team is developing a smartphone application (app) and~     website for AYA with chronic pain. The app will help AYA to track pain, sleep, mood,~     activities, and exercise and help AYA set and achieve goals. The website will give~     information about pain and how to manage it independently. We will build the program and make~     sure it is easy to use and understand. We will also test if the program can be put into~     practice as planned and if AYA using the program feel less pain, have less limitations, and a~     better quality of life.~   "
73745|NCT02601599|"~     Background: Smoking counselling during hospitalisation with post-discharge follow-up~     increases quitting. However, provision of cessation care for hospitalised patients is~     suboptimal. Students are potentially an untapped resource for providing cessation advice, but~     no studies have investigated this.~      Aim: To determine if medical students can encourage motivation to stop smoking (MTSS; primary~     outcome) in hospitalised smokers .~      Design: 2-arm RCT Setting: RCSI (www.rcsi.ie) and Connolly Hospital~     (www.hse.ie/eng/services/list/3/hospitals/Connolly/).~      Participants: Inpatient smokers. Intervention and procedures: 60 graduate medical students~     will receive standardised motivational interviewing training in the provision of cessation~     advice. Each student will be randomly assigned to counsel ~1-3 smokers each, including an~     individual in-hospital, face-to-face session and post-discharge phone counselling. Training~     and implementation will cover Sept-2015-May-2016. Smokers will be randomised to 'usual care'~     (n~90), or intervention (n~90, student-delivered motivational interviewing). A researcher~     will enable recruitment and follow-up, and conduct a qualitative evaluation of programme~     participants.~   "
87913|NCT02416362|"~     The purpose of this study is to analyze the immediate effects of two exercise protocols on~     the vibration platform, on the strength of the thigh muscles, joint position sense of the~     knee and balance in healthy subjects.~   "
73734|NCT02601742|"~     Acute diarrhea is the third cause of infant mortality in the world causing 15% of all deaths~     in children under 5 years and is responsible for nearly 1.4 million deaths in developing~     countries. It is considered a self-limiting disease and to this problem the recommendation of~     the World Health Organization (WHO) is the administration of zinc with low osmolarity oral~     dehydration salts for a period of 10-14 days which reduces the severity of the episode.~      In Mexico COFEPRIS believes the zinc salt as a food supplement and not a drug and the above~     problem is presented in terms of prescribing and access of this salt to the general~     population. In Mexico the investigators have the provision and accessibility of low~     osmolarity oral dehydration salts supplemented with adequate doses of zinc, which is~     inexpensive for the general population and offering a solution in terms of supply and~     management.~      The purpose of the study involves the evaluation Pedialyte diarrhea in the treatment of acute~     diarrhea in children under 5 years. The investigator sconsider the use of Pedialyte diarrhea~     eases their access to the population in general and it is low cost compared with the zinc~     salt that is sold only in specialized pharmacies under strict medical prescription Objective:~     Compare the duration of symptoms of acute diarrhea in the treatment with low osmolarity oral~     rehydration salts (Pedialyte) vs treatment of low osmolarity oral rehydration supplemented~     with zinc (Pedialyte diarrhea) Study Desing: Double blind, randomized, controlled.~   "
73735|NCT02601729|"~     Type 1 diabetes mellitus (T1DM) is an autoimmune disease caused by an immune mediated~     destruction of the pancreatic β-cells. Once the pancreas has been depleted of a critical mass~     of β-cells the need for exogenous insulin therapy emerges. Several methods exist to~     administer insulin. An alternative way to administer insulin is by means of continuous~     subcutaneous insulin infusions (CSII) or insulin-pump therapy.The frequent execution of~     self-monitoring of blood glucose (SMBG) accomplished by a capillary finger-stick test is~     essential in the management of diabetes, but this is very limited and also lacks information~     about rising or falling trends in the actual glycaemia. A solution for this is the use of a~     Real-Time Continuous Glucose Monitoring (RT-CGM) device. Contrary to SMBG, RT-CGM measures~     glycaemia 24 hours a day, provides information about glucose direction and rate of change~     during multiple days a week. Since September 2014, RT-CGM is reimbursed in Belgium for a~     selected group of type 1 diabetic patients by means of a so-called CGM convention. The main~     objective of the study is to evaluate the impact of real time continuous glucose monitoring~     reimbursement on real-life clinical care parameters of type 1 diabetic patients in Belgium~     after 12 and 24 months.~   "
73736|NCT02601716|"~     This is an open-label evaluation of the safety, tolerability, immunogenicity and efficacy of~     PfSPZ Vaccine administered by direct venous inoculation (DVI) in healthy, malaria-naïve adult~     subjects.~   "
73737|NCT02601703|"~     This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study~     to Evaluate the Therapeutic Equivalence of a Generic Tacrolimus Ointment, 0.1% (Glenmark~     Pharmaceuticals, Ltd) to the Marketed Product Protopic® (tacrolimus) ointment, 0.1% (Astellas~     Pharma US, Inc.) in the Treatment of Moderate to Severe Atopic Dermatitis (AD).~   "
73738|NCT02601690|"~     This is a research study intending to look at the response of a specific type of allergy~     cells in the blood (called T cells) to a a type of immunotherapy product known as SPIREs~     (Synthetic Peptide Immuno-Regulatory Epitopes), across a broad range of subjects. This is a~     non-interventional study in which no investigational product will be administered to any~     subject.~   "
73739|NCT02601677|"~     Nucleus accumbens/anterior limb of internal capsule play important roles in the process of~     treatment-refractory obsessive compulsive disorder, deep brain stimulation of nucleus~     accumbens/anterior limb of internal capsule will inhibit its activity and thus to effectively~     prevent the disorder.~   "
73740|NCT02601664|"~     Design: Single center, single-blind randomized controlled trial of patients with high risk~     native coronary artery lesions (defined as ≥2 contiguous yellow blocks on the block~     chemogram) requiring clinically indicated percutaneous coronary intervention. Patients will~     be randomized to either a combined intervention or conventional PCI. Cardiac biomarker~     measurements will be performed before PCI and 18-24 hours later.~      Treatment: Combined intervention consisting of pre-PCI intracoronary vasodilator and~     glycoprotein IIb/IIIa inhibitor administration, use of an EPD if technically feasible, and~     complete coverage of the lipid core plaque, if technically feasible.~      Control: Conventional PCI. Duration: 30 days follow-up. The primary trial objective is to~     compare the incidence and size of periprocedural MI, as assessed by the peak post-PCI~     troponin distribution in the two study groups.~      The secondary endpoints are: (1) Reduction in the incidence of >3x and >10x upper limit of~     normal increase in CK-MB. (2) Reduction in the incidence of slow flow/no-reflow post PCI. (3)~     Lower incidence of major adverse cardiac events, defined as the composite of death, acute~     coronary syndrome, or coronary revascularization) during 30-day follow-up.~   "
73741|NCT02601651|"~     The primary objectives of this study is to access the effect of perioperative lidocaine~     infusion on total morphine requirement during the first 24 h postoperatively in patients who~     underwent laparoscopic totally extraperitoneal inguinal hernioplasty.~   "
73742|NCT02601638|"~     Patients undergoing total laryngectomy are at high risk for 30-day unplanned readmission.~     Many of these readmissions are related to stomal care, and it is thought that the~     readmissions could be prevented with better patient and caregiver education. The~     investigators are studying the effect of a comprehensive perioperative education program on~     30-day unplanned readmission for patients undergoing total laryngectomy.~      The comprehensive perioperative education program will include the following additional~     interventions:~      -Preoperative visit with the speech pathologist for explanation of laryngectomy physiology,~     stomal education, and alaryngeal voice rehabilitation. Participants will be expected to~     undergo this intervention and to attend it with their laryngectomy coach (a family member~     or friend to accompany the patient through the education process), but failure to meet with~     the speech pathologist will not exclude a patient from the study.~        -  Preoperative education class with a designated ENT laryngectomy nurse for patient and~          caregiver. The hands-on class introduces the patient and laryngectomy coach to the~          basics of stomal care. Participants and their laryngectomy coach will be expected to~          attend the preoperative education class~        -  Printed laryngectomy journey guide given to patients at time of study enrollment for~          patient/caregiver. This journey guide details the preoperative, in-hospital, and~          post-discharge course and is provided as a reference throughout their journey.~        -  Formalized, nursing administered practical evaluation of minimal competency of~          laryngectomy care for patient and caregiver/laryngectomy coach.~      This study will follow patients prospectively from the time of study commencement and then~     assess changes in patient knowledge before and after the education intervention. It will also~     compare rate of stomal complications and readmission rates to institutional historical~     averages to assess improvement in quality care.~   "
73743|NCT02601625|"~     This is a Phase I, Randomized, Placebo-Controlled, Double-Blind Study to Assess the~     Pharmacokinetics and Safety of anifrolumab following Single-Dose administration to healthy~     subjects~   "
73744|NCT02601612|"~     The purpose of this study is to evaluate the safety and immunogenicity of the RSV D46cpΔM2-2~     vaccine in RSV-seropositive children and RSV-seronegative infants and children.~   "
73750|NCT02601534|"~     The goal of the study is to evaluate the effectiveness of a family-focused, interactive, and~     theory-based intervention to reduce the sedentary behavior and increase physical activity,~     family communication and well-being of the participants.~      The intervention is to use Zero-time Exercise, the positive psychology theme Appreciation~     and Gratitude [23, 24], and role modelling approach to get sedentary people to start~     exercising, increase levels of physical activity, family communication and well-being of the~     participants and their family members.~      The intervention aims to encourage positive and sustainable health actions among participants~     and their family members.~   "
73751|NCT02601521|"~     Specific Aim: To conduct a randomized controlled trial among permanent employees of Partners~     HealthCare, Inc., and their adult dependents, who are current tobacco smokers. The trial will~     compare two interventions designed to help smokers stop using tobacco: (1) External Coaching~     Program (Standard Care) and (2) Internal Coaching Program, a chronic disease management~     strategy for treating tobacco use and dependence.~   "
73752|NCT02601508|"~     This study is designed to evaluate the surgeon's satisfaction with either deep or moderate~     neuromuscular blockade during laparoscopic gastrectomy surgery and observe the recovery~     profiles in the recovery room and the ward.The explorative objective of this study is to~     evaluate the safety profiles of deep and moderate neuromuscular blockades via observation of~     postoperative complications.~   "
73753|NCT02601495|"~     In this study the investigators will seek to improve their understanding of how positive and~     negative valence systems, cognition, and arousal/interoception are inter-related in disorders~     of trauma, mood, substance use, and eating behavior for women involved in a court diversion~     program in Tulsa, Oklahoma (Women in Recovery). The investigators will recruit 100~     individuals and use a wide range of assessment tools, neuroimaging measures, blood and~     microbiome collections and behavioral tasks to complete the baseline and follow-up study~     visits. Upon completion, the investigators aim to have robust and reliable dimensional~     measures that quantify these systems and a set of assessments that should be recommended as a~     clinical tool to enhance outcome prediction for the clinician and assist in determining who~     will likely benefit from the diversion program, and to inform future revision or augmentation~     of the program to increase treatment effectiveness.~   "
73754|NCT02601482|"~     A single bout of Interval-Walking (IW) exercise is superior to energy-expenditure and~     time-duration matched Continuous Walking (CW) exercise upon improving glycemic control. The~     time spend with high-intensity (fast) walking is considered to be responsible for the~     improvements seen, whereas the time spend with low-intensity (slow) walking is considered~     less important.~      This study will assess if IW with maintained fast walking time duration but reduced total~     time duration (i.e. reduced slow walking time duration) is equally effective as IW with a~     normal time duration.~      Subjects with type 2 diabetes will be included in a crossover, controlled study, where each~     subject will undergo three trials. Trials will be identical except the following~     interventions:~        1. Sixty minutes of rest (CON)~        2. Sixty minutes of classical interval walking (repeated cycles of 3 minutes of fast and 3~          minutes of slow walking; IW-60)~        3. Fourty-five minutes of time-reduced interval walking (repeated cycles of 3 minutes of~          fast and 1.5 minutes of slow walking; IW-45).~      After the interventions subjects will undergo a standardized mixed meal tolerance test with~     assessment of glycemic control.~   "
73755|NCT02601469|"~     An open label, safety study to assess the potential for adrenal suppression following maximal~     use treatment with DSXS administered twice daily for 28 days in patients with moderate to~     severe plaque psoriasis.~   "
73756|NCT02601456|"~     The purpose of this study is to determine the effect of prolonged effort in long distance~     running on the biomechanical bilateral asymmetry in the lower limbs of trans tibial amputee~     running with running specific prosthesis.~   "
73757|NCT02601443|"~     The incidence of multiple gestations has increased over the past years, mostly because of~     increased use of assisted reproductive technologies. Triplet pregnancies are at increased~     risk of preterm birth (PTB), which is the primary reason for their increased morbidity and~     mortality compared to singletons. Multiple gestations, including triplets, account for about~     3% of all pregnancies in the US but constitute at least 10% of cases of PTB, over 30% of very~     low birth weight infants, and nearly 20% of infant mortality.~      A short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good~     predictor of PTB, including in multiple gestations. In singletons with a prior PTB and a~     short CL <25mm before 24weeks, cerclage is associated with significant decreases in PTB and~     perinatal morbidity and mortality in the meta-analysis of randomized trials (RCTs). On the~     contrary, the effect of cerclage in multiple gesttations has been insufficiently studied,~     with meta-analysis data showing a possible harm from cerclage compared to controls.~      The aim of this RCT is to evaluate the efficacy of cervical pessary in prevention of PTB in~     unselected triplet gestations.~      We planned to assess outcomes in subgroup analysis of women with short cervical length (TVU~     CL <30 mm)~   "
73758|NCT02601430|"~     The purpose of this study is to determine if an MRI technique called Blood Oxygen Level~     Dependent, or BOLD, can be used to evaluate blood flow in the leg before and after treatment~     with standard endovascular therapy in patients with chronic lower limb ischemia.~   "
73759|NCT02601417|"~     Acute cholangitis with obstructive jaundice is a condition which needs biliary drainage and~     appropriate antibiotics. Bile culture is an optional laboratory test according to 2013 Tokyo~     guideline, but the clinical significance is yet unproven. And its results might indicate less~     information of the true pathogen regarding normal flora. Previous study conducted at our~     institute found drug-resistant pathogens identified in bile culture had no impact on the~     outcome. So the investigators are conducting a multicenter randomized controlled trial~     comparing groups which considers both blood and bile culture as control and which considers~     only blood culture as trial group in order to prove bile culture provides no additional~     helpful clinical information.~   "
73785|NCT02601079|"~     Endodrill is a new instrument for biopsy sampling in the GI-channel. The purposes of this~     study are as follows:~        -  Compare the Endodrill instrument with conventional biopsy forceps in terms of ability to~          establish the correct diagnosis based on collected biopsies of tumors in the upper GI~          tract.~        -  Based on the quality of the collected tissue samples we want to evaluate which~          instrument generates the most useful material for genetic studies of the tumor.~   "
73760|NCT02601404|"~     Current drug-eluting stents (DES) has demonstrated excellent clinical outcomes in patients~     with coronary artery disease. However, a continued risk of clinical events even several years~     after the procedure is reported. Stent platform or polymer-associated inflammation may play a~     role.~      Bioresorbable scaffold (BRS) is known to disappear 2 to 3 years after the implantation, which~     may result in the more favorable very long-term clinical outcomes compared with metallic~     stents. The initial clinical experiences of BRS in relatively simple lesion subsets were~     comparable to DESs.~      BRS, however, is limited by the disadvantageous mechanical characteristics such as thick~     strut and the risk of fracture by overdilation. There is concern that BRS is less optimal for~     complex lesion subsets such as bifurcation lesions, calcified tortuous lesions, or diffuse~     long lesions. Real world registry is needed to test the feasibility and safety of BRS in~     these complex lesion subsets.~   "
73761|NCT02601391|"~     The purpose of this study is to determine how effective the STEPPS-HI group is at improving~     emotional regulation skills in those with identified difficulties in this area within~     forensic inpatient services. In addition, to explore whether there is increased acceptability~     of the adapted STEPPS group (STEPPS-HI) for this client group.~   "
73762|NCT02601378|"~     This study is to characterize the safety, tolerability, pharmacokinetics (PK),~     pharmacodynamics (PD) and preliminary anti-tumor activity of LXS196 as a single agent and in~     combination with HDM201 in patients with metastatic uveal melanoma.~   "
73763|NCT02601365|"~     This study will investigate the safety and efficacy of the administration of inhaled GM-CSF~     to children with respiratory virus-associated pneumonia.~   "
73764|NCT02601352|"~     The study mainly focuse on examining the subjects living in traffic polluted area and~     assessing the popuation health risk using disease and risk assessment models.~   "
73765|NCT02601339|"~     This study uses frequency domain near-infrared spectroscopy coupled with diffuse correlation~     spectroscopy (FDNIRS-DCS) technology for monitoring cerebral blood flow (CBF) and cerebral~     oxygen metabolism (CMRO2) at the bedside for newborns with germinal matrix-intraventricular~     hemorrhage (GM-IVH) and/or post-hemorrhagic hydrocephalus (PHH) in comparison to newborns~     with hydrocephalus of a different etiology (VC) and healthy controls (HC). We hypothesize~     that baseline cerebral metabolic dysfunction is a better biomarker for GM-IVH and PHH~     severity and response to PHH treatment.~      This is a Boston Children's Hospital (BCH)-institutional review board(IRB) approved,~     multi-site study that includes collaboration with Brigham and Women's Hospital (BWH) and Beth~     Israel Deaconess Medical Center (BIDMC). Pei-Yi Lin receives funding from The National~     Institute of Health (NIH) to support the study and is the overall principal Investigator (PI)~     overseeing the study.~   "
73766|NCT02601326|"~     A comparative randomized study between laparoscopic ventral mesh Rectopexy and Delorme's~     procedure in treatment of complete rectal prolapse to ass both efficacy and complications~   "
73767|NCT02601313|"~     Study KTE-C19-102 is a phase 2, multicenter, open-label study evaluating the efficacy of~     KTE-C19 in subjects with Relapsed/Refractory MCL~   "
73768|NCT02601300|"~     This is a phase 2, open-label, multicenter study to explore the efficacy and safety of oral~     GED- 0301 in subjects with active UC, defined as a modified Mayo score (MMS) ≥ 4 and ≤ 9 and~     a Mayo endoscopic subscore≥ 2.~      Approximately 40 subjects will be enrolled using an Interactive Voice Response System (IVRS)~     or an Interactive Web Response System (IWRS) to receive open-label, oral GED-0301 160 mg for~     duration of 52 week treatment. Enrollment of subjects with previous exposure to TNF-α~     blockers will be limited to approximately 15 subjects. The number of subjects with extensive~     colitis is targeted to comprise approximately 50% of the entire study population.~   "
73769|NCT02601287|"~     This is a safety and efficacy study of BOTOX® (Botulinum Toxin Type A) in the Treatment of~     Adult Korean Patients with Urinary Incontinence due to Neurogenic Detrusor Overactivity or~     Overactive Bladder.~   "
73770|NCT02601274|"~     A Phase I, open-label, multicenter dose-escalation study to assess the safety, tolerability,~     pharmacokinetics and preliminary anti-tumor activity of hmpl-309 in patients with advanced~     solid tumors~   "
73771|NCT02601261|"~     Investigating the influence of Internet use to the level of state anxiety in hospitalized~     women with pathological pregnancy.~      A recent research shown that the prevalence of antenatal anxiety changes during pregnancy at~     first trimester is 36.3%; the rate dropped to 32.3% at second trimester but increased again~     to 35.8% at third trimester (art. 29).According to the World Health Organization, mental~     health disorders are the leading cause of disease burden in woman from 15 to 44 years~     (art.6). A Swedish study indicated that the incidence of moderate or extreme symptoms of~     anxiety and depression of pregnant woman during the first trimester is 15,6% (art. 3).~   "
73772|NCT02601248|"~     First-in-human study is conducted to assess the maximum tolerated dose (MTD) and~     dose-limiting toxicity(DLT), safety and tolerability, pharmacokinetics (PK), and preliminary~     anti-tumor activity of Theliatinib .~   "
73773|NCT02601235|"~     The purpose of this study is to evaluate the efficacy of the Naridrin in improving nasal~     congestion.~   "
73774|NCT02601222|"~     The purpose of this study is to evaluate the efficacy and safety of Runzao zhiyang capsule in~     treating chronic eczema.~   "
73775|NCT02601209|"~     This partially randomized phase I/II trial studies the side effects and best dose of~     sapanisertib and to see how well it works compared to pazopanib hydrochloride in treating~     patients with sarcoma that is too large to be removed (locally advanced) or has spread to~     other areas of the body (metastatic). Sapanisertib and pazopanib hydrochloride may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
73786|NCT02601066|"~     This research study includes patients ages 1 to 25 years old with Lamin A/C related muscular~     dystrophy (LMNA-MD). The goal of this study is to evaluate how the heart is affected in~     children and teens with LMNA-MD. The evaluation includes an echocardiogram, an~     electrocardiogram, an electrophysiological study and the implantation of a subcutaneous ECG~     holter monitor.~   "
73824|NCT02600572|"~     Determine the changes in attention level due to isometric exercises and level three~     progression eccentric movements. The attention level will be measured using a mental speed~     test (how quickly a subject can process information and make decisions based upon that~     information). Another outcome measure will be the ability of the subject to maintain balance~   "
73776|NCT02601196|"~     Hypothesis:~      After reviewing the relevant medical data the investigators assume that treating a woman with~     intramural fibroid not distorting the uterine cavity or mostly intramural with less than 50%~     submucosal component with Ulipristal Acetate (UPA) for a 13 weeks course would reduce the~     fibroid size and improve her chance for conceiving by IVF treatment.~      Materials & Methods:~      Study design: A proof of concept prospective not randomized study. The patients: About 20~     women treated in the fertility and IVF unit after at least one IVF failure, with mostly~     intramural (IM) fibroid [class 2-5 by FIGO (International Federation of Gynecology and~     Obstetrics) classification system] in the size of >4 cm confirmed by Transvaginal ultrasound~     (TVUS) and diagnostic hysteroscopy.~      After US examination and diagnostic hysteroscopy to ascertain suitability for this study, the~     investigators will offer a course of 13 weeks treatment with UPA 5 mg per day.~      One month after cessation of treatment the investigators will perform another TVUS~     examination & diagnostic hysteroscopy plus endometrial biopsy in order to assess the~     endometrial & uterine status and will conduct an additional IVF cycle, using the same~     stimulation protocol undertaken during the immediate cycle previous to the UPA treatment~     course.~   "
73777|NCT02601183|"~     The cerebrovascular diseases can be approximately divided as two types, namely ischemic and~     hemorrhagic stroke. Intravenous thrombolysis within 3-4.5 hours is highly recommended for~     acute ischemic stroke patients. But it's difficult to diagnose the ischemic stroke with the~     hemorrhagic stroke from the early symptoms and signs. It's with high risk of enlarging the~     hematoma if the patients with hemorrhagic stroke received the thrombolytic drugs. And time~     cost by CT or MRI examination is likely to responsible for missing the narrow time window and~     poor prognosis of stroke patients. Consequently, seeking for a noninvasive, rapid, portable~     and inexpensive diagnosis method which can sensitively distinguish the stroke type before CT~     or MRI examination would be very helpful in treating the ischemic stroke patients.~      Because of the blockage in the cerebral supply artery, the heat from circulatory system will~     sharply decrease in infracted hemisphere among the ischemic stroke patients. The reduced~     brain temperature influenced the temperature on the ipsilateral forehead according to the~     data of our animal and preliminary clinical trial. In contrast, the temperature of the~     ipsilateral hemisphere showed a mild increase among the ischemic stroke patients in our~     preliminary experiment. The difference of the temperature tendency on the ipsilateral~     forehead has a great chance to be an early physical mark.~      In our study, 30 ischemic stroke patients and 30 hemorrhagic stroke patients will be~     recruited. In the process of recruitment, the patients with acute stroke attack in no more~     than 4.5 hours will be collected the temperature at the five point without head coverage,~     including ipsilateral tempora, ipsilateral forehead, galbella, contralateral forehead, and~     contralateral tempora. Then the stroke would be recruited into the ischemic and hemorrhagic~     group according to the later CT or MRI results in the hospital. The accuracy and sensibility~     of early brain temperature in distinguishing stroke type would be tested in comparison with~     the diagnosis of imaging examination.~   "
73778|NCT02601170|"~     Severe hemophilia is characterized by frequent and lifelong bleeding, with more than 60% of~     bleeds occurring into joints . Repeated joint bleeding leads to chronic synovitis, cartilage~     damage and bony destruction. Currently available treatment of hemophilic arthropathy, such as~     analgesics, NSAIDs, and hyaluronic acid (HA), are predominantly directed toward the~     symptomatic relief of pain and inflammation, but they do little to reduce joint cartilage~     degeneration.~      Platelet-Rich Plasma (PRP) is a simple and minimally invasive method that provides a natural~     concentrate of autologous growth factors from the blood. This method is now being~     increasingly applied in clinical practice to treat musculoskeletal disorders, such as tendon~     repairment and osteoarthritis. To the best of our knowledge, no study applies PRP for~     arthropathy of knee joint in hemophilia patients. The aim of the study is to investigate the~     efficacy, safety and duration of benefit of single PRP injection versus five weekly~     intra-articular injections of HA in patients with hemophilic arthropathy of knee.~   "
73779|NCT02601157|"~     We had little experience in coronary intervention with recently introduced newer drug-eluting~     stent (DES) platforms, despite great anticipation, and optimal duration of dual antiplatelet~     therapy (DAPT) for these stent systems still needs to be established.~      With a 2x2 factorial design for patients of stable angina or silent ischemia, the~     investigators formulate a head-to-head randomized comparison between sirolimus-eluting Orsiro~     stent with biodegradable polymer and polymer-free stent platform with the same~     antiproliferative agent, Coroflex ISAR stent system. At the same time, clopidogrel treatment~     is added to aspirin during the 3-months period after the stenting, and this abbreviated~     duration of DAPT will be compared with conventional 1-year mandatory DAPT regimen in a 1:1~     randomized stratification. 1-year target lesion failure (TLF) as a composite of cardiac~     death, target vessel related myocardial infarction and clinically driven target lesion~     revascularization will be identified as a primary efficacy outcome. And in addition to TLF,~     definite or probable stent thrombosis and major bleeding events will also be counted as a~     composite outcome of net adverse clinical events (NACEs) to comprehensively adjudicate the~     efficacy and safety outcomes according to the difference of DAPT duration.~      With this trial, you will be able to get clear insight on the behavior of newer DES~     platforms. Reference data for the shortened mandatory DAPT regimen will also be delineated in~     the selected patients, and it might be helpful to those who need it.~   "
73780|NCT02601144|"~     This is the first study on the effect of the variable frequency stimulation (VFS) on Freezing~     of gait (FOG) in Parkinson's disease (PD) patients with STN DBS. FOG has responded poorly to~     High frequency stimulation (HFS) but can be alleviated by relatively VFS. This study would~     have significant clinical implications in the management of Freezing of gait (FOG) in these~     PD patients with subthalamic nucleus (STN) DBS. The investigators hypothesize that VFS could~     have better effect on FOG than HFS and low frequency stimulation (LFS).~   "
73781|NCT02601131|"~     The purpose of this study is to identify how the platelet count, complement system and~     endothelial markers are affected over time, after platelet transfusion in 4 different~     hematological patient groups.~   "
73782|NCT02601118|"~     This study was undertaken to investigate the effectiveness of the Micro Expression Training~     Tool (METT) and the Subtle Expression Training Tool (SETT) to help improve the non-verbal~     communication skills of medical students.~   "
73783|NCT02601105|"~     The purpose of this study is to clinically evaluate the efficacy, safety as well as patient~     satisfaction in the use of topical Centella asiatica (CA) on the cosmetic appearance of~     stretch marks.~   "
73784|NCT02601092|"~     Several retrospective studies have shown same efficiency in regard to weight loss, with a~     lower rate of complications for the laparoscopic mini gastric bypass (LMGB) compared to~     Roux-en-Y gastric bypass (LRYGB). The aim of this double-blinded randomized controlled trial~     is to compare the two procedures in respect of excess weight loss, complications, operation~     time, length of stay and the metabolic impact on the hormonal brain-gut-axis.~   "
74227|NCT02595294|"~     The purpose of these study is to compare the effectivity of the Cervical Lateral Glide~     physical therapy neural mobilization technique to the complete absence of treatment in a~     group of patients who suffer cervicobrachial pain.~   "
73787|NCT02601053|"~     For centuries the term blood curling has been used to describe extreme frightening~     situations. However, the origin of this ancient theory has never been studied and it remains~     unknown if fear induces the coagulation system.The objective was to explore the effects of~     acute fear on the coagulation system while sitting still. In a crossover study design healthy~     subjects will be exposed to a horrifying e.g. scary movie followed by a dull e.g. flat movie~     which is shown at least 1 week after the first movie on the same day of the week at the same~     time of the day. Participants will be recruited among students from the Leiden University~     Medical Center. Blood will be drawn from the cubital vein 10 minutes before the first movie,~     directly after the first movie. The same will be done 10 minutes before and directly after~     the second movie. Blood is drawn by using a needle puncture.~      Individual markers of coagulation activity will be determined from the blood samples. Pulse~     rates will be measured and an anxiety/fear score will be collected from each student for both~     movies.~   "
73788|NCT02601040|"~     The main purpose of this study was to evaluate the safety and immunogenicity of~     Immunogenicity of Inactivated and Live Attenuated Hepatitis A Vaccines for healthy Chinese~     people.~   "
73789|NCT02601027|"~     The purpose of this trial is to determine if using abdominal nerve blocks when patient~     undergo breast reconstruction can significantly decrease use of pain medications after~     reconstructive surgery.~   "
73790|NCT02601014|"~     This phase II trial studies how well nivolumab and ipilimumab work in treating patients with~     hormone-resistant prostate cancer that has spread to other places in the body and express~     androgen receptor-variant-7 (AR-V7). Tumor cells expressing AR-V7 has been shown to be~     resistant to hormone therapy and some chemotherapy in patients with prostate cancer.~     Biomarker-driven therapy, such as nivolumab and ipilimumab, may work by blocking key~     biomarkers or proteins that help tumor cells to escape the immune system surveillance and~     this may help the immune system to kill tumor cells that express AR-V7.~   "
73791|NCT02601001|"~     The purpose of this study is to evaluate the PK, safety and tolerability of omecamtiv~     mecarbil in healthy volunteers.~   "
73792|NCT02600988|"~     The purpose of this study is to determine whether vitamin D is effective in the prevention of~     graft-versus-host-disease after completion of allogeneic transplant.~   "
73793|NCT02600975|"~     This is a clinical trial in which healthy volunteers will be administered an experimental~     malaria vaccine, R21. The R21 vaccine will be administered with the adjuvant AS01B.~      All vaccinations will be administered intramuscularly. Each volunteer will receive three~     vaccinations in total.~      There are two different vaccine schedules:~      Group 1 will receive R21 10µg with AS01B on days 0, 28, and 56. Group 2 will receive R21 50µg~     with AS01B on days 0, 28, and 56.~      The study will assess the safety of the vaccine, and the immune responses to the vaccination.~     Immune responses are measured by tests on blood samples.~      Healthy adult volunteers will be recruited in Oxford and Southampton, England.~   "
73794|NCT02600962|"~     The aim of the study is to investigate the impact of an initial non-specific / non-cardiac~     diagnosis on mortality among patients hospitalised with acute myocardial infarction.~   "
73795|NCT02600949|"~     The goal of this clinical research study is to learn if it is possible to make a vaccine for~     advanced pancreatic or colorectal cancer. In this study, you will receive the vaccine in~     combination with pembrolizumab. The safety of this vaccine in combination with pembrolizumab~     will also be studied.~      This study will use your tumor cells (either from a fresh biopsy or from leftover tissue~     samples) and blood to help create a vaccine designed specifically for you based on what the~     study doctor and research staff can learn about the type of mutated proteins (a type of~     genetic change) in the tumor.~      This is an investigational study. The study vaccine is not FDA approved or commercially~     available. It is currently being used for research purposes only. Pembrolizumab is FDA~     approved and commercially available for the treatment of melanoma, non-small cell lung~     cancer, and squamous cell head and neck cancer. It is considered investigational to use~     pembrolizumab to treat pancreatic or colorectal cancer.~      The study doctor can explain how the vaccine is designed to work.~      Up to 60 participants will be enrolled in this study. All will take part at MD Anderson.~   "
73796|NCT02600936|"~     The Sinai Vein Stent Registry aims to establish and maintain a registry of patients who have~     undergone a vein stent placement procedure at The Mount Sinai Medical Center. The purpose of~     this study is to monitor and evaluate the long-term outcomes of venous stents placed to treat~     venous outflow obstruction. Outcome variables that will be assessed are: patency rate,~     reintervention rate, occurrence of any complications, clinical improvement, and quality of~     life. Venous outflow obstruction is defined as a stenosis and/or occlusion seen primarily in~     the ilio-femoral vein and inferior vena cava, and infrequently in the subclavian vein,~     brachiocephalic vein, or superior vena cava. While vein stent placement procedures are~     currently being performed in the United States, using stents which are commercially available~     and FDA-approved for use in arterial interventions, at this time there are no stents that are~     FDA-approved for use in veins. The placement of stents in veins holds tremendous promise as a~     treatment for venous outflow obstruction, but review of current literature has showed a~     paucity of published data on the long-term outcomes of this treatment.~      The study is composed of two arms, a retrospective arm and a prospective arm. Any patient~     over the age of 18 who has undergone or is scheduled to undergo a vein stent placement~     procedure is eligible for this study. A HIPAA waiver and waiver of informed consent are being~     requested for the retrospective arm for patients who have undergone a vein stent placement~     procedure from January 1st 2012 to date of study onset, as it is not possible to contact all~     patients in the retrospective arm (i.e., lost to follow-up, no longer follows-up with a study~     physician). This study is only interested in the collection and analysis of data; the~     clinical care and outcomes of research subjects will not be affected by their participation~     in this study.~      An IDE application has been submitted to the FDA for use of the Wallstent™ (manufactured by~     Boston Scientific, Inc.) in veins as treatment for venous outflow obstruction. The primary~     stents being used as treatment for venous outflow obstruction at Mount Sinai is the~     Wallstent™, mainly due to the fact that only Wallstents™ are available in the appropriate~     sizes to be used in veins. In rare occasions or exceptional circumstances, a smaller~     self-expanding nitinol stent may be used. Due to the extremely rare frequency of stents other~     than Wallstents™ being used and the impracticality (if not impossibility) of obtaining IDEs~     for all other stents, the investigators believe it is appropriate to exclude usage of these~     stents from the study data. To confirm, the purpose of this study is to monitor and evaluate~     long-term outcomes of the venous stents/the vein stent placement procedure, not specifically~     the Wallstent™ itself.~   "
73797|NCT02600923|"~     The purpose of this study is to provide access to palbociclib in Mexico and in selected Latin~     American countries before it becomes commercially available to patients with HR~     positive/HER2-negative ABC who are appropriate candidates for letrozole therapy.~   "
73823|NCT02600585|"~     The primary objective of this study is to retrospectively characterize the safety of Flublok~     in adults 18 years of age and older, in comparison with egg-based trivalent or quadrivalent~     inactivated influenza vaccines (IIVs), using a methodological approach designed to query the~     database of electronic health records (EHR) maintained by Kaiser-Permanente, Northern~     California (KPNC), a large medical care organization (MCO).~   "
73798|NCT02600910|"~     Over 300,000 people in the United States have spinal cord injuries and many use manual~     wheelchairs for mobility. Most manual wheelchair users will develop shoulder injuries and~     pain that greatly affect quality of life and level of independence. Understanding when~     shoulder disease starts in manual wheelchair users and which daily activities contribute to~     the disease will provide necessary evidence for effective primary prevention methods to~     inhibit the development of further disability. Our central hypothesis is that the development~     of shoulder disease in manual wheelchair users will be strongly associated with the~     cumulative exposure to elevated shoulder postures combined with high upper body loading.~   "
73799|NCT02600897|"~     This study will evaluate the safety, efficacy, and pharmacokinetics of induction treatment~     with obinutuzumab, polatuzumab vedotin, and lenalidomide in participants with relapsed or~     refractory (R/R) follicular lymphoma (FL) and rituximab in combination with polatuzumab~     vedotin and lenalidomide in participants with R/R diffuse large B-cell lymphoma (DLBCL),~     followed by post-induction treatment with obinutuzumab in combination with lenalidomide in~     participants with FL who achieve a complete response (CR), partial response (PR), or stable~     disease (SD) at end of induction (EOI) and post-induction treatment with rituximab plus~     lenalidomide in participants with DLBCL who achieve a CR or PR at EOI.~   "
73800|NCT02600884|"~     The purpose of this research study is to evaluate a brief parent-based adolescent sexual~     health intervention called Families Talking Together Plus (FTT+). FTT+ is based on an~     established intervention called Families Talking Together (FTT) and will enhance FTT by~     adding modules on human papillomavirus (HPV). The goal of the study is to evaluate whether~     FTT will help parents increase sexual health communication, delay adolescent sexual debut,~     and increase HPV vaccination. FTT will be delivered to parents of minority youth and will be~     delivered by student nurses.~   "
73801|NCT02600871|"~     The purpose of this study is to determine if the use Provodine as an antiseptic and hand wash~     once daily for at least 7 days will have better healing, better health outcomes, fewer~     treatment failures and fewer infections themselves and among their household contacts than~     those who do not use Provodine.~   "
73802|NCT02600858|"~     The study determines whether standard medical care (dopamine) affects learning and retention~     of an upper limb feeding task in people with Parkinson's disease (PD) and whether training on~     the feeding task generalises to performance on an untrained upper limb buttoning task. Half~     the participants will train on the feeding task after they have taken their first dose of~     dopamine for the day (i.e. on medication state), while the other half will train on the~     same feeding task before taking their first daily dose of dopamine (i.e. off medication~     state).~   "
73803|NCT02600845|"~     This post-market, interventional, prospective, single arm, the United States (US) based~     multi-center study will assess the change in treatment satisfaction of participants who~     utilize the ACCU-CHEK Connect Diabetes Management System over a period of 6 months.~   "
73804|NCT02600832|"~     The proposed study is a pilot prospective, parallel groups, randomized, double blind, sham~     training-controlled, 9-session (over 3 weeks) clinical trial of AABM in 32 male and female~     veterans entering treatment for AUD at the VA Medical Center at San Francisco, California,~     between ages 18-65. The study consists of screening, 3-week AABM training, Week-4 post-test,~     and Week-12 follow-up. Assessment of inhibitory control, alcohol approach bias and craving~     will be administered at baseline and Week-4. Immediately following screening, patients will~     be randomly assigned to receive 9 sessions of real or sham AABM training (16 subjects each)~     taking place over three weeks. Following the 3 weeks of training, patients will complete a~     Week-4 post-test which includes assessment of alcohol approach bias, inhibitory control, and~     craving and a Week-12 follow-up assessing drinking behavior.~   "
73805|NCT02600819|"~     This study will evaluate the safety and tolerability of~     elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose~     combination (FDC) in HIV-1 infected adults with end stage renal disease (ESRD) on chronic~     hemodialysis (HD) at Week 48.~   "
73806|NCT02600806|"~     A clinical protocol was developed for the management of adult outpatients with~     community-acquired pneumonia (CAP) and Pneumonia Severity Index risk classes I-II. Patients~     are assigned to oral azithromycin or levofloxacin according to procalcitonin (PCT) levels~     measured with a rapid point-of-care method. When PCT levels are <0.5 ng/ml, azithromycin, 500~     mg/day is given orally for 5 days; if PCT is ≥0.5 ng/ml, levofloxacin, 500 mg/day is given~     orally for 7 days~   "
73807|NCT02600793|"~     Ceftaroline fosamil is an intravenous (IV) drug that belongs to a group of antibiotics called~     cephalosporins . Antibiotics are drugs used to treat infections. Clinical studies in adults~     patient shave shown ceftaroline fosamil to be effective against many bacteria that are~     resistant to other currently approved antibiotics. Some of these bacteria may be responsible~     for infections in the central nervous system.The main aim of this study is to gather~     information to determine how much of a single IV dose of ceftaroline fosamil will enter into~     a child's CSF so that the benefit of giving ceftaroline fosamil to children with infections~     can be better determined.~   "
73808|NCT02600780|"~     Febuxostat is a potent, nonpurine, selective inhibitor of Xanthine oxidase that exhibits~     antihyperuricemic activity by reducing the formation of uric acid. The investigators~     conducted an interventional, two-arm, randomized, open label pilot study on patients with~     serum urate level ≥ 6.8 mg/dL. Patients were treated with Febuxostat 40 mg Tablets or~     Allopurinol 300 mg Tablets once daily dose for 90 days to determine the efficacy and safety~     of Febuxostat in comparison with Allopurinol in Hyperuricemic Subjects with or without Gout.~   "
73809|NCT02600767|"~     This is an in vivo evaluation of drug efficacy performed in Cruzeiro do Sul, in the state of~     Acre, Brazil. A total of 81 participants ≥5 years old with parasitological confirmation of P.~     falciparum monoinfection will be treated under supervision with artemether-lumefantrine for~     three days, with doses according to the Brazilian guidelines for malaria control. The~     clinical and parasitological parameters will be monitored for a 28-day follow-up period to~     evaluate the efficacy of the combination therapy. A blood sample will be collected on filter~     paper on the first day and on the day of suspected failure to try to differentiate the~     parasite genotypes using techniques based on polymerase chain reactions. The results of this~     efficacy evaluation on the drug combination will help the Brazilian Ministry of Health to~     evaluate the national policy for treatment of malaria caused by P. falciparum.~   "
73810|NCT02600754|"~     This study aims to find an effective and sustainable approach to reducing disparities in~     accessing mental health services for an underserved and growing population group of~     low-income, racially diverse, homebound older adults. It will compare two aging-service~     integrated, teledelivered depression treatments for these seniors. One model is short-term~     problem-solving therapy by licensed clinicians; the second model is self-care management~     support by trained lay advisors. The findings are expected to create a foundation of~     information for guiding the implementation of acceptable, effective, and sustainable~     depression care within widely available aging-service infrastructures.~   "
73811|NCT02600741|"~     The primary purpose of this study is to evaluate the overall effect of caregivers receiving a~     study-provided caregiver psycho-education and skills training program on the number of~     treatment failures (psychiatric hospitalization, psychiatric emergency room (ER) visit,~     crisis center visit, mobile crisis unit intervention, arrest/incarceration, and suicide or~     suicide attempt) in patients under their care during a 12 month period.~   "
73812|NCT02600728|"~     Deficits in automatic motor control, characteristic of Parkinson's disease (PD), contribute~     to progressive impairment in gait performance. The use of declarative memory cues in order to~     promote the engagement of attention and activation of the next movement in gait may minimize~     the consequences of lack of automatic control. The purpose of this study is to verify the~     long-term efficiency of a new strategy based on declarative memory cue to improve the gait~     performance and independence in daily life activities (DLA) in patients with PD.~   "
73813|NCT02600715|"~     The purpose of this study is to test whether using belladonna & opiate suppositories (B&Os)~     can improve patient discomfort during Onabotulinumtoxin A (BoNT) injection into the bladder~     for treatment of overactive bladder, neurogenic detrusor overactivity, or interstitial~     cystitis.~   "
73814|NCT02600702|"~     The purpose of this study is to compare the exercise protocol called Siriraj home base~     exercise program for OA knee to usual care and physical modalities for conservative~     treatment in patients with 1st OA knee.~   "
73815|NCT02600689|"~     Outpatient (phase 2) pulmonary rehab is an important, but mostly underutilized intervention~     to improve physical function in patients with idiopathic pulmonary fibrosis (IPF). Of those~     individuals who complete phase 2 pulmonary rehab, only a small cohort continues with any type~     of maintenance exercise therapy (phase 3). This is largely due to personal factors, such as~     access to transportation, weather, scheduling difficulties, and cost.~      Little is known about how to enhance physical activity among patients with IPF. In addition,~     no studies have investigated the long-term maintenance strategies of physical training in~     patients with IPF. Thus, the purpose of this study is to test the feasibility and~     effectiveness of a home-based, pulmonary rehab program for patients with IPF. A randomized,~     blinded, clinical trial (RCT) design with two arms -- Wii Fit Plus exergame program and~     cognitive video gaming, with no active whole body movement involved — will be used to~     investigate the benefits of a home-based exergame program on improving pulmonary-related~     function and symptoms in patients with IPF.~   "
73816|NCT02600676|"~     This is a randomized, double blind, placebo controlled study of the effect of Sacral~     Transcutaneous Electric Nerve Stimulation (TENS) in fifty-two children with monosymptomatic~     nocturnal enuresis (MNE).~   "
73817|NCT02600663|"~     Patients with acute back pain (<6 weeks) presenting at their general practitioner will be~     enrolled. Patients fulfilling all inclusion criteria and showing no exclusion criteria will~     fill out the Heidelberg short questionnaire (HKF-R10) and the Keele STarT Back Screening~     Tool. These two questionnaires categorize back pain patients into individuals at risk of~     chronic back pain and those not at risk. Furthermore, data concerning pain location,~     severity, duration and impairment will be collected. Study participants will receive standard~     care treatment prescribed by their general practitioner. Six months later, study participants~     will receive a questionnaire in order to collect data concerning their present pain~     situation. Patients with relevant impairment in their activities of daily living as a result~     of back pain will be categorized as individuals with chronic back pain. Categorization at six~     months will be compared with the categorization at presentation.~   "
73818|NCT02600650|"~     The purpose of this study is to determine whether a proprietary 'testosterone-boosting'~     supplement, when used as recommended by the manufacturer, results in an increase in~     testosterone levels as measured by a salivary free testosterone assay.~   "
73819|NCT02600637|"~     Summary: Thousands of Veterans suffer a stroke every year, and these individuals often suffer~     emotional and cognitive changes that negatively affect their quality of life as well as their~     ability to recover. In addition to traditional rehabilitation such as physical and~     occupational therapy, a number of alternative treatments are now being studied for their~     ability to enhance patients' recovery following stroke. One of these treatments,~     Mindfulness-Based Stress Reduction or MBSR, involves an 8-week course that teaches~     individuals strategies such as breathing techniques, meditation, and movement therapy. The~     current pilot study proposes to teach MBSR to a group of Veterans with a history of stroke to~     determine whether this type of intervention is feasible, acceptable to patients, and shows~     preliminary evidence of beneficial effects on psychological and cognitive functioning. The~     investigators hope to find that MBSR is a useful, additional intervention that can improve~     Veterans' well-being and quality of life as they recover from stroke.~   "
73820|NCT02600624|"~     The purpose of this study is to examine the association between maternal alcohol use and~     newborn phosphatidylethanol (PEth) levels in their newborn.~   "
73821|NCT02600611|"~     This is a multicenter, randomized, double-blind study of the efficacy and safety of iclaprim~     compared to vancomycin for the treatment of skin and skin structure infections.~   "
73822|NCT02600598|"~     This is a Phase I, single-centre, open label, within-subject comparison trial to explore the~     biological effects of LEO 43204 Gel, 0.037%, applied once daily for 3 consecutive days in~     patients with actinic keratosis on the upper extremity. The treatment area for each patient~     will be as defined as a contiguous area of 250 cm2 of skin on the upper extremity (including~     the dorsum manus) that contains a minimum of 5 AK lesions. Additionally there must be at~     least one AK lesion located in a non-treated area on the contralateral arm. All eligible~     subjects will receive LEO 43204 Gel, 0.037%, on the treatment area on Days 1, 2 and 3. Study~     medication application will be (sub)investigator applied. A total of 30 patients will be~     enrolled into this study (n=15 in each of the two groups). Patients will be divided into two~     groups with different biopsy schedules.~   "
73825|NCT02600559|"~     This is an 8-week, multicenter, open-label study in which eligible subjects with a history of~     otitis media requiring TT placement will receive 6 mg OTO-201 to each ear. The study is~     designed to evaluate the safety and efficacy of OTO-201 in subjects undergoing TT placement~     with common concurrent surgeries and any middle ear effusion status.~   "
73826|NCT02600546|"~     Evaluate the repeatability and reproducibility of the RTVue-XR for measuring the total~     corneal thickness (pachymetry), the epithelial thickness, and the stromal thickness mapping~     in normal subjects and corneal patients.~   "
73827|NCT02600533|"~     This study will measure the effects of an office-based, clinical trial education video on~     clinical trial knowledge and enrollment in clinical trials, in a clinical sample with no~     previous history of clinical trial participation. This study will also determine the~     feasibility of implementing an office-based video educational program.~   "
73828|NCT02600520|"~     The present study is designed as a single-centre, randomized, controlled clinical trial to~     evaluate and compare the clinical and radiographic efficacy of two local drug delivery~     systems containing 1.2% RSV gel and 1.2% ATV gel in treatment of intrabony defects in~     patients with chronic periodontitis as an adjunct to SRP.~   "
73829|NCT02600507|"~     The study will evaluate the efficacy and safety of ITI-007 adjunctive to lithium or valproate~     in a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in~     patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode.~   "
73830|NCT02600494|"~     The study will evaluate the efficacy and safety of ITI-007 in a randomized, double-blind,~     parallel-group, placebo-controlled, multi-center study in patients diagnosed with Bipolar I~     or Bipolar II disorder having a major depressive episode.~   "
73831|NCT02600481|"~     This study is aimed to determine whether low- and standard-pressure pneumoperitoneum have~     different impacts on troponin T（TnT) level as well as pulmonary complications after prolonged~     robot-assisted surgeries in the Trendelenburg position.~   "
73832|NCT02600468|"~     The purpose of this study to collect information on the safety, especially serious infections~     and malignancies, and efficacy of the long-term use of ORENCIA Intravenous Infusion 250mg in~     patients with rheumatoid arthritis.~   "
73833|NCT02600455|"~     The purpose of this study to collect information on the safety, especially localized~     injection site reactions, and efficacy of ORENCIA Subcutaneous Injection 125mg Syringe 1mL in~     patients with rheumatoid arthritis.~   "
73834|NCT02600442|"~     A correlation between early changes in the tumor maximum standardized uptake value (SUVmax)~     on FDG-PET after one or two cycles of neoadjuvant chemotherapy (NAC) and the pathological~     response after 6 to 8 cycles has been demonstrated in several independent small series of~     patients.~      Breast tumor proliferation status has previously been demonstrated to be a good predictive~     factor of response to chemotherapy. The best method for assessing proliferation status is~     unclear. Proportion of cells staining for nuclear Ki67 antigen is the most widely used assay~     for comparing the proliferation status between tumors. However major variations in analytical~     procedure and interpretation limited its clinical value. Taking into account the prognosis~     and predictive value of proliferation gene as a common signature in breast cancer~     transcriptome analysis, quantitative assessment of mRNA expression of genes involved in~     proliferation has been developed by the investigators team and others. The evaluation of~     these parameters is quantitative and reliable and can be standardized for a clinical use.~      The main objective of the investigators study is to early predict pathological response to~     anthracycline-based neoadjuvant chemotherapy (NAC) using a combination of parameters based on~     FDG-PET imaging performed at baseline and after 2 cycles, and molecular markers of~     proliferation measured on pre-treatment biopsy (Ki67 protein level by immunohistochemistry~     and Ki67 mRNA level and the mRNA (messenger RNA) expression of the most pertinent genes of~     the Genomic Grade Index (GGI) component by RT (reverse transcriptase) - qPCR).~   "
73835|NCT02600429|"~     The objective of this study is to assess the safety and efficacy of RGN-259 Ophthalmic~     Solution compared to placebo for the treatment of NK.~   "
73836|NCT02600416|"~     The aim of this study is to determine the effects of AV port reversal (AVPR) on~     recirculation, clearance, post-filter ionized calcium and subsequently citrate dosing.~   "
73837|NCT02600403|"~     The aim of this study was to evaluate structural and functional improvement after lowering~     intraocular pressure (IOP) in patients with glaucoma using Spectral Domain Optical Coherence~     Tomography (SD-OCT), Visual Field (VF) testing, and Visual Evoked Potential (VEP).~   "
73838|NCT02600390|"~     SANGUINATE™ Sickle Cell Disease associated Leg Ulcers.~   "
73839|NCT02600377|"~     Vegetarian and vegan diets have been shown to reduce chronic disease risk, including diabetes~     and cardiovascular disease, as well as several cardiometabolic risk factors. Whether~     vegetarian and/or vegan dietary patterns improve cardiometabolic risk factors in individuals~     with diabetes remains unclear. To address the uncertainties, the investigators propose to~     conduct a series of systematic reviews and meta-analyses of the totality of the evidence from~     randomized controlled trials to distinguish the effect of vegetarian and/or vegan diets on~     the prevention and management of diabetes. The findings generated by this proposed knowledge~     synthesis will help improve the health of consumers through informing evidence-based~     guidelines and improving health outcomes by educating healthcare providers and patients,~     stimulating industry innovation, and guiding future research design~   "
73840|NCT02600364|"~     The purpose of this study is to assess safety and effectiveness of the p64 Flow Modulation~     Device.~   "
73841|NCT02600351|"~     The primary objective of this study is to evaluate the efficacy, safety, and tolerability of~     ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) for 12 weeks with or without~     ribavirin (RBV) in participants without cirrhosis, and LDV/SOF FDC for 12 weeks with RBV or~     LDV/SOF FDC for 24 weeks without RBV in participants with cirrhosis.~   "
73890|NCT02599714|"~     This dose finding/extension study consists of three parts: Part A will identify the MTD of~     the AZD2014/palbociclib combination on a background of fulvestrant (referred to as the~     triplet) in postmenopausal women with locally advanced/metastatic estrogen receptor positive~     (ER+) breast cancer. Part B will further characterize safety, tolerability, PK, and~     preliminary efficacy in single-arm dose expansion groups. Part C will investigate the~     efficacy of the triplet combination in a double-blind, placebo-controlled, stratified,~     parallel group extension.~   "
73842|NCT02600338|"~     Legumes are generally recognized as healthy dietary components, and although beans and~     legumes are recommended in food guidelines in North America, guidelines vary in regards to~     how much and how often these foods should be consumed. Furthermore, although North American~     and European guidelines recommend dietary pulses for glycemic control, dietary pulses and~     other legumes are not specifically suggested for controlling blood pressure and maintaining~     heart health. To improve evidence-based guidance for legume recommendations, the~     investigators propose to conduct a systematic review of clinical studies to assess the effect~     of eating legumes in exchange for other foods on blood pressure in humans. The systematic~     review process allows the combining of the results from many small studies in order to arrive~     at a pooled estimate, similar to a weighted average, of the true effect. The investigators~     will be able to explore whether eating legumes has different effects in different~     demographics, and whether or not the effect of legumes depends on how much/often they are~     eaten. The findings of this proposed knowledge synthesis will help improve the health of~     Canadians through informing recommendations for the general public, as well as those at risk~     of heart disease and diabetes.~   "
73843|NCT02600325|"~     New and recently EMA/FDA approved direct acting antiviral (DAA) combination therapies cure~     95% or more of the patients chronically infected with HCV genotype 1 and 4. Grazoprevir~     (MK-5172) and elbasvir (MK-8742) combination therapy is such a, albeit not yet EMA/FDA~     approved combination DAA therapy.~      It is likely that the synergistic effect of the host's immune response and antiviral therapy~     when given during the first 6 months of HCV infection makes antiviral therapy during acute~     HCV infection more effective. In this study the investigators would like to document that~     treatment of acute HCV with grazoprevir (MK-5172), elbasvir (MK-8742) is effective and can~     ben shortened from 12 to 8 weeks for HCV genotype 1 and 4 infection without substantial loss~     in efficacy.~      Study design and intervention:~      Prospective open label interventional clinical trial in which 80 acute HCV genotype 1 or 4~     patients co-infected with HIV will receive 8 weeks of grazoprevir and elbasvir (a once-daily~     combination tablet).~      Study population:~      80 Adult HIV positive patients with an acute HCV genotype 1 or 4 infection from 10 HIV~     treatment centers in the Netherlands and Belgium will be included.~      Primary endpoint: Sustained viral response (SVR) 12 weeks after the end of therapy in ITT~     study population (=genotype 1 and 4).~   "
73844|NCT02600312|"~     The Oxiris® filter is a registered product for CRRT already safely used in routine care.~      In in vitro experiments, the Oxiris® filter has been demonstrated to adsorb endotoxin and~     cytokines. Compared to conventional filters this may be advantageous in patients with severe~     sepsis but neither decreased levels of endotoxin and cytokines nor an improved outcome has~     been demonstrated with clinical use.~      But there are so far little clinical data on the oXiris® filter on humans. The oXiris® filter~     will be investigated in a double blind randomized crossover setting against a traditional~     filter (ST150). Either filter will be used for 24 hours after which it will be changed to the~     opposite filter for another 24 hours.~      Arterial blood samples will be drawn at start and then 1, 3, 8, 16 and 24 hours after the~     start of each filter, and analyzed for endotoxin (EAA assay), TNF-α, IL-1β, IL-6 and IL-10~     (ELISA) levels. Standard blood tests will be analyzed simultaneously. Data concerning mode~     and settings of CRRT, heart rate, blood pressure, medication, data concerning ventilatory~     support and pathogen will be registered.~      Primary endpoint: Levels of endotoxin and cytokines will be compared using Student's paired~     t-test on AUC values for each 24-hour period.~   "
73845|NCT02600299|"~     As cancer mortality rates improve in Asia, there is an increasing focus on patient-reported~     outcomes and survivorship issues. In view of the numerous medication and psychosocial issues~     that are commonly faced by early-stage breast cancer survivors, it deems important to develop~     and conduct specific interventional programs to mitigate these problems. In the literature,~     it is well recognized that psychosocial interventions are effective to manage emotional~     distress and quality of life, with the evidence clearly clustered in studies on female~     patients with breast cancer. One meta-analysis suggested that psycho-oncologic interventions~     including individual psychotherapy, group psychotherapy, psychoeducation, relaxing training~     can produce positive effects on emotional distress, anxiety and depression, and~     health-related QOL.~      The investigators hypothesize that a significant reduction in anxiety, improvement of~     cognition and improvement of health-related quality of life among those who receive~     psycho-education, in comparison to those in the usual care. Hence, this randomized trial is~     designed to assess the effectiveness of a psycho-educational group (PEG) intervention on~     supportive care and survivorship issues, which include anxiety, depression, cognitive~     function, toxicities management of cancer- or treatment- related physical symptoms, and~     health-related quality of life in early-stage breast cancer patients.~   "
73846|NCT02600286|"~     The disease Charcot-Marie-Tooth disease type 1A (CMT1A) is the most common inherited~     peripheral neuropathy, for which no treatment has proved its effectiveness. It is autosomal~     dominant, associated with a duplication of the chromosome 17p11.2 region which leads to~     overexpression of the gene and the protein-peripheral myelin protein-22 (PMP22), a major~     component of peripheral myelin.~      In animals and humans, PMP22 mRNA level of glutathione S-transferase theta 2 and Cathepsin A~     (markers of oxidative stress), detected in a skin biopsy are markers that may play a role in~     the prognosis evolution of the disease. Furthermore, several studies have shown that the~     administration of progesterone increased the expression of PMP22 gene (measured in a skin~     biopsy) and worsening symptoms. In contrast, anti-progestins reduce the synthesis of PMP22~     and improve symptoms in rat CMT1A.~      The long-term safety of anti-progesterone was evaluated for mifepristone (RU486) ulipristal~     acetate and (EllaOne®). Few side effects have been reported including a few cases of~     endometrial hyperplasia reversible upon discontinuation of treatment. With the RU486, rare~     cases of adrenal androgen and failure have been observed. However, EllaOne® has low~     antagonistic action on the glucocorticoid receptor and no action on androgen receptors. The~     investigators therefore believe that it will be well tolerated in humans and will reduce the~     synthesis of PMP22 and the action of oxidative stress by improving disability of patients.~   "
73847|NCT02600273|"~     The purpose of this study is to assess initial reactions to alternative nicotine/tobacco~     products among smokers living with HIV.~   "
73848|NCT02600260|"~     Hospitalization in pregnancy and childbirth greatly increases the thromboembolic risk of~     these patients. The application of a protocol for assessing the risk of VTE reduces mortality~     and morbidity of these phenomena.~   "
73849|NCT02600247|"~     This study aims to compare the effectiveness of duloxetine after total knee arthroplasty in~     Central sensitization patient. Central sensitization plays an important role in the chronic~     pain experienced by osteoarthritis patients.Elimination of the nociceptive input from the~     damaged joint by total joint arthroplasty was not always followed by a complete resolution of~     symptoms. Patients with high levels of preoperative pain and low pain thresholds had a higher~     risk of persistent pain after total knee arthroplasty (TKA), which has been interpreted as~     evidence of central sensitization. Thus, the presence of central sensitization before surgery~     in Osteoarthritis patients may be an important contributing factor to postoperative pain~     versus adequate analgesia. Preclinical models of central sensitization suggest that~     duloxetine is effective in the treatment of persistent pain. Investigators will compare the~     pain following TKA of central sensitization patients in duloxetine group (n=50) with those in~     non-duloxetine group (n=84). Investigators will classify the central sensitization patients~     by central sensitization inventory and divide the central sensitization patients in to 2~     groups (duloxetine and non-duloxetine group) randomly. Investigators checks the visual~     assessment scale at preoperative, postoperative 1, 2,6,12 weeks. All participants will~     receive postoperative pain control after TKA using the same pain control regimen except~     duloxetine.~   "
73850|NCT02600234|"~     A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial~     Pressure in Patients with Heart Failure.~   "
73851|NCT02600221|"~     To investigate the distributions of the patients with ACOS, asthma and COPD over age 40 with~     chronic airflow limitation in China.~   "
73852|NCT02600208|"~     This is a single arm pilot study for patients with hematologic malignancies with alternative~     donor sources receiving unrelated or partially matched related/Haploidentical mobilized~     peripheral stem cells (PSCs) using the CliniMACS system for Alpha Beta T cell depletion plus~     CD19+ B cell depletion to determine efficacy as determined by engraftment and GVHD, and one~     year leukemia free survival.~   "
73853|NCT02600195|"~     This 4-year cluster randomized controlled trial aims to determine whether implementation of~     Evidence-based Practice for Improving Quality (EPIQ) method can reduce hospital-acquired~     infection in Chinese Neonatal Intensive Care Units (NICUs).~   "
73854|NCT02600182|"~     The purpose of this study was to determine the effects of Bilevel Positive Airway Pressure~     (BiPAP) on variables clinics, cardiorespiratory and physical functional in patients~     undergoing cardiac surgery at the University Hospital of Santa Maria.~   "
73855|NCT02600169|"~     This study is a retrospective cohort study. A database will be created from the data~     available of all patients that have participate in the named patient program for~     pembrolizumab in the Netherlands. This database will be used for analysis of response markers~     and for an evaluation of adverse events.~   "
73856|NCT02600156|"~     The primary purpose of this study is to evaluate the feasibility and safety of MRI-guided~     focal laser ablation (Laser-Induced Interstitial Thermal Therapy, LITT) to treat low-risk~     native prostate cancer.~   "
73857|NCT02600143|"~     The aim of this trial is to identify biomarkers and genetic predisposition for the~     development of immune checkpoint related colitis.~   "
73858|NCT02600130|"~     This is a Phase I, prospective, randomized, placebo-controlled, double-blinded study designed~     to test the safety and efficacy of LMSCs (Longeveron Mesenchymal Stem Cells) for the~     treatment of subjects with clinically diagnosed Alzheimer's disease.~   "
73859|NCT02600117|"~     Recent evidence suggests that patients with inactive chronic hepatitis B (CHB) may develop~     the same types of liver complications that patients in the active state of hepatitis B virus~     (HBV) infection experience. Treatment guidelines for patients in the active state of HBV~     infection indicate that HBsAg clearance is associated with definitive remission of the~     activity of chronic HBV & improved long-term outcome. Clinical data showed that HBsAg~     clearance is achievable, in a small population of patients on continuous treatment with~     potent oral antivirals (OAVs), such as tenofovir disoproxil fumarate (TDF). It is possible~     the same OAVs can have the same effect in patients with inactive CHB, but in a shorter~     treatment duration. The purpose of this study is to find out if TDF is effective in~     controlling HBV DNA & promoting seroconversion from HBsAg-positive to HBsAb-positive in~     patients with inactive CHB.~   "
73860|NCT02600104|"~     Prospective clinical study, Up to 100 healthy adult volunteers seeking Treatment of Wrinkles~     Reduction in the facial area, males or females of 18 to 75 years of age, from up to 5~     investigational sites.~   "
73861|NCT02600091|"~     Type 1 and 2 diabetes are challenging conditions to manage. Anxiety and depression are common~     among this group and are associated with poorer diabetes control. No trials have been~     conducted to ascertain the effectiveness of psychological interventions designed to alleviate~     significant levels of anxiety and/or depression and improve glycaemic control among those~     with diabetes who have significant difficulties with their emotional wellbeing and diabetes~     control.~      The aim of this project is to establish if it is feasible to run a multi-site randomised~     controlled trial in Scotland exploring whether an 8-week mindfulness and self-management~     based intervention programme decreases anxiety and/or depression, and improves diabetes~     control. This feasibility study, based on the MRC framework for assessing feasibility and~     piloting methods, will assess the relative strengths and weaknesses of the intervention and~     study design, and pave the way for a larger and definitive trial.~   "
73862|NCT02600078|"~     With exposure to high altitude some individuals will develop acute mountain sickness (AMS).~     Current evaluation of AMS can make it difficult to rule out other possible conditions.~     Evaluation of ataxia, as measured by the performance of a coordinated task, can aide in the~     correct diagnosis of AMS. The investigators have developed novel finger-tapping tasks on a~     mobile device to assess both reaction time and accuracy. The proposed research will evaluate~     the utility of this tool in assessing human acclimatization to hypoxia.~   "
73863|NCT02600065|"~     Radio(chemo)therapy is the standard therapy for both, brain tumors and brain metastases.~     Neurological decline is observed in these patients and tumor progression or radiotherapy side~     effects have been made responsible for this. However CMV encephalitis may also be a reason.~     Therefore the investigators aim to analyze the CMV status in patients during and after~     radio(chemo)therapy. It will be checked by CMV-DNA (PCR analysis) and CMV antibodies (IgG and~     IgM ELISA) in the blood of the patients. These findings will be correlated with changes in~     the brain, visualized by MRI. In addition a detailed immunophenotyping in the peripheral~     blood will be performed.~   "
73864|NCT02600052|"~     INTRODUCTION:~      Parkinson's disease (PD) is a neurodegenerative disorder that causes motor disorders such as~     bradykinesia, rigidity and tremor. In addition to the motor symptoms occurring in the overall~     PD patients, mostly there is associated respiratory disorders. The respiratory impairment may~     be due by postural changes, limiting the flexibility and expandability of the chest wall~     causing decreased lung volumes and flows. So the exercise Proprioceptive Neuromuscular~     Facilitation (PNF) is a tool designed to reduce the changes in respiratory function, the~     commitment of the respiratory muscles, and allows greater flexibility of the chest wall,~     reducing the rigidity of the rib cage. To evaluate the effects of respiratory pattern of~     Proprioceptive Neuromuscular Facilitation on the distribution of pulmonary ventilation,~     compartmental volumes of diaphragmatic mobility and functional capacity in patients with~     Parkinson's disease.~      METHODS:~      The study is a clinical trial randomized, in which participants to be elected for the study~     should present diagnosis of PD, staging of disease between II and III according to Hoehn and~     Yahr. Initially, the participants will undergo the collection of data on medical history,~     assessment of pulmonary function by spirometry and respiratory muscle strength measured by~     the manometer. Then will undergo evaluation of the breathing pattern and tricompartmental~     distribution of the volume of the chest wall by hemithorax by Plethysmography Optoelectronic;~     Quantify the mobility of the right diaphragm in total lung capacity for maneuver and during~     the current volume by ultrasonography. After the evaluation, participants will undergo~     intervention which will consist of three stages: first occur first session of the PNF later~     aerobic training for 30 minutes, ending with one PNF session.~   "
73865|NCT02600039|"~     Cystic Fibrosis (CF) is the most common lethal autosomal recessive disease. Respiratory~     therapy is always recommended to the CF patient with pulmonary involvement and has differents~     techniques and devices, however, there is no consensus on the effectiveness of the techniques~     used, there is a need to determine the applicability of the therapeutic resources used.~     Therefore, the aim of the study is to determine the short-term effectiveness of ELTGOL on~     Average Electrical Impedance on the End of Expiration (MIEFE) pulmonary, assessed by~     Electrical Impedance Tomography (EIT) in individuals with CF through a clinical trial~     randomized crossover. Volunteers will be included with FC with moderate to severe lung~     disease with chest ≥ 74 cm that do not show: episode of pulmonary infectious exacerbations in~     the last four weeks or during the study period; cor pulmonale; facial deformity that causes~     air leakage; facial trauma and recent face or esophagus surgery; chest pain; hemoptysis in~     the last week; continued use of supplemental oxygen (> 8 hours / day); hemoptysis;~     hemodynamic instability and do not understand the use and command of the techniques used. The~     sample is selected by convenience from the database of individuals assisted data in~     Integrative Medicine Institute Professor Fernando Figueira (IMIP). The research will be~     developed in three phases, divided into three days with an interval of at least 48 hours~     between phases. The first day will undergo initial assessment and in the days following the~     intervention by day, ELTGOL or Acapella, in a randomized order.~   "
73866|NCT02600026|"~     This study will use an in-car monitoring system supplemented with video feedback to reduce~     the number of unsafe driving behaviors. If successful, this technology will provide a means~     to enhance public safety on the roads that could be adopted immediately in this at-risk group~     of drivers. The intervention will also maximize the time for independent driving, improving~     the overall quality of life of these individuals.~   "
73867|NCT02600013|"~     The aim of this observational, non-controlled, non-profit study is to describe the responses~     to rehabilitative training with the robotic exoskeleton EKSO-GT in patients with incomplete~     motor Spinal Cord Injury (AIS C or D). Such rehabilitative tool is employed during inpatient~     intensive rehabilitation in a 3rd level Italian hospital. Safety and tolerability of the~     device are also assessed and described.~   "
73868|NCT02600000|"~     Heart failure (HF) is configured major problem for public health in the country. Affected~     individuals may experience fatigue, dyspnea, respiratory muscle weakness, overstimulation of~     the sympathetic myocardial activity, among others. In relation to the treatment of patients~     with heart failure with symptoms mentioned above a great alternative is the implantation of~     cardiac rehabilitation programs, these programs can also be associated with other muscle~     training measures, among these there is inspiratory muscle training (IMT), as the weakness of~     these muscles is rather found in this population and this directly related to signs and~     symptoms. OBJECTIVE: To evaluate the efficacy of inspiratory muscle training associated with~     a cardiac rehabilitation program in the modulation of sympathetic myocardial activity and~     maximal and submaximal functional capacity of patients with HF between 21-60 years.~     METHODOLOGY: This is a clinical trial, controlled, randomized, double-blind being developed~     in partnership with the Department of Physical Therapy, Federal University of Pernambuco~     (UFPE) and the Hospital das Clinicas (HC) of Pernambuco, whose patients will be accrued on~     the Recife's main referral centers in caring for patients with heart failure. Patients will~     undergo the evaluation of pulmonary function and respiratory muscle strength (spirometry and~     digital Manovacuometry) as well as on the functional capacity (Ergospirometry), cardiac~     innervation (myocardial scintigraphy), mobility and diaphragm thickness (ultrasound) and~     quality of life. After the evaluation will be randomly allocated into two groups: The control~     group will perform cardiac rehabilitation associated with the Sham of IMT, and the~     experimental group cardiac rehabilitation associated with the IMT at 30% of maximal~     inspiratory pressure. The intervention will last three months for both groups and after this~     phase patients will be submitted again to the assessment tools. EXPECTED RESULTS: To clarify~     the association between physical exercise associated with specific respiratory training in~     modulating the autonomic nervous system of patients with HF and what the relationship with~     reflected cardiorespiratory fitness in maximal and submaximal functional capacity.~   "
73876|NCT02599896|"~     Background:~      Antibodies help the body fight infection. VRC01LS is an antibody directed against HIV virus.~     HIV attacks the immune system. In animals, VRC01LS inactivated many types of HIV viruses.~     Researchers want to see if it does this in people.~      Objectives:~      To see if VRC01LS is safe and well-tolerated in people. To see what level of VRC01LS is~     maintained in people and if they develop an immune response to it.~      Eligibility:~      Healthy people ages 18 to 50~      Design:~      Participants will be screened in protocol number VRC 500 (NIH 11-I-0164) with medical~     history, physical exam, and blood and urine tests.~      The study will last 24 to 48 weeks. Visits will last 2 to 8 hours.~      Participants will get VRC01LS through either:~        -  A needle in an arm vein or~        -  A small needle placed into the fatty tissue under the skin of the abdomen, thigh, or~          arm.~      Participants will be assigned to 1 of 6 groups.~      Groups 1 to 4 will get 1 dose of VRC01LS. They will have follow-up visits through week 24.~      Groups 5 and 6 will get 1 dose of VRC01LS every 12 weeks (3 doses). They will have 4 to 5~     visits between the second and third dose, and follow-up visits through week 48.~      Participants will have 1 to 3 follow-up visits in the week after receiving VRC01LS. They will~     record their temperature and keep a diary of symptoms for 3 days after a dose. They may have~     additional unscheduled visits.~      At each visit, participants will have a physical exam and may have blood and urine tests.~   "
73869|NCT02599987|"~     Background: Patients with chronic kidney disease on hemodialysis may have reduced diffusion~     capacity, lung function and gas exchange due to mechanical and hemodynamic changes in the~     respiratory system, and decreased respiratory muscle strength resulting from uremic myopathy.~     The inspiratory muscle training (IMT) appears as an instrument to improve the inspiratory~     muscle strength, with positive effects on functional capacity and quality of life of kidney~     patients, however, the effects of IMT were not addressed in the specific variables of the~     respiratory system and to date there are no studies on the use of daily training in this~     population. Objective: To evaluate the effectiveness of daily inspiratory muscle training on~     respiratory muscle strength, chest wall volume, diaphragm thickness and mobility of end-stage~     renal disease patients. Methods: A randomized controlled clinical trial to be developed in~     Cardiopulmonary Physical Therapy Laboratory of the Universidade Federal de Pernambuco (UFPE)~     during the period from November 2015 to December 2016. The sample is composed of 24~     individuals aged 18 and 65, having CKD, to perform hemodialysis for at least twelve months~     and provide inspiratory muscle weakness. Patients will be divided into two groups, the~     training group will be IMT with POWER-breathe®, load of 50% of MIP, duration of three sets of~     30 inspirations, frequency of two sessions per day, 7 days a week for 8 weeks, since the sham~     group will be subjected to the same procedure (duration and frequency), but without load.~     Participants will be assessed before and after intervention through a global assessment form,~     questionnaire Kidney Disease Quality of Life Instrument Short Form - KDQOL-SF, diaphragmatic~     ultrasound, opto-electronic plethysmography, spirometry, manometer and six-minute walk test.~   "
73870|NCT02599974|"~     The two main objectives of this prospective study are:~        -  to identify those patients for whom pre-treatment FDG (Fluorodeoxyglucose) PET (positron~          emission tomography) CT-scan (Computed tomography scan) provides useful information for~          the treatment of breast cancer (ASAINT 1),~        -  to improve FDG PET-CT-scan imaging criteria for assessing response to neoadjuvant~          therapy early, in M0-patients (ASAINT 2).~      The secondary objective is to better understand the interactions between the imaging~     parameters of FDG PET-CT-scan and biological and histological features of breast cancer .~      This is a non-interventional study. Two PET-CT-scans are performed, one before starting~     treatment, and the other after 2 cycles of neoadjuvant chemotherapy. The two PET-CT-scans are~     prescribed by oncologists from the center of breast diseases Unit at St. Louis hospital, in~     Paris, France. Oncologists provide clear information to the patients on the purpose of the~     examination. The examinations are performed in the nuclear medicine department at St. Louis~     hospital. PET-CT-scans data, tumor characteristics, results of other imaging and biological~     tests, results of surgery and patient's follow-up are summarized in a de-identified file.~     This file has been declared to the National Commission on Informatics and Liberties (CNIL).~     The data in this file are established prospectively and secondary analyzed to assess the~     precise role of PET-CT-scans in the initial staging of breast cancer and to determine the~     optimal PET-CT-scans criteria to evaluate response to neoadjuvant treatment early.~   "
73871|NCT02599961|"~     UX007G-CL202 is an open-label, single-arm, multi center extension study to assess the~     long-term safety and efficacy of UX007 in Glut 1 DS. The study will enroll up to 40~     pediatric, adolescent and adult Glut 1 DS subjects who have completed the UX007G-CL201 study~     or participated in qualified ISTs.~   "
73872|NCT02599948|"~     Assessment of nutritional practices in french intensive care units.~   "
73873|NCT02599935|"~     To assess the effect over the nutritional status in patients who are malnourished with~     chronic heart failure, of an educational intervention and the provision of nutritional~     supplements. Randomized clinical trial with blind assessors. Unicentric. Follow up: 12 months~   "
73874|NCT02599922|"~     This will be a non-randomized, open-label, Phase 1/2 study of the safety and efficacy of~     rAAV2tYF-PR1.7-hCNGB3 administered to one eye by subretinal injection in individuals with~     achromatopsia caused by mutations in the CNGB3 gene. The primary study endpoint will be~     safety and the secondary study endpoint will be efficacy.~   "
73875|NCT02599909|"~     Background:~      There are about 100 trillion microbial cells in a person s gut. This is called the human gut~     microbiota. When this is disrupted, it can lead to many diseases. Studies show that the gut~     microbiota in people with cancer is different than that found in healthy people. Researchers~     want to study links between the gut microbiota and the immune system in people with a liver~     disease called hepatocellular carcinoma (HCC).~      Objective:~      To study links between gut microbiota and the immune system in people with HCC.~      Eligibility:~      People at least 18 years old with HCC. They must be scheduled to have tumors removed by~     surgery.~      Design:~        -  People having surgery for primary liver tumors at the Mount Sinai Medical Center will be~          screened for this study.~        -  At the initial visit, blood, rectal swabs, urine, and stool will be collected.~          Participants will answer questions about their medical condition.~        -  Before surgery, blood, rectal swabs, urine, and stool will be collected. This will be~          done at a routine visit.~        -  When they have surgery, a piece of liver tissue with the tumor will be collected. This~          will be sent to the National Cancer Institute for tests.~        -  After surgery, blood, rectal swabs, urine, and stool will be collected 3 times. This~          will be done at routine visits.~   "
73886|NCT02599766|"~     The purpose is to investigate whether animal-assisted therapy has positive biopsychosocial~     effects on patients with brain injuries. This study investigates the short-term~     biopsychosocial effects that occur when animals are present during therapy sessions in~     comparison to therapy sessions without animals, observing a group of 25 patients over 24~     therapy sessions. While half of the sessions are held in presence of an animal and half~     without, they are as comparable as possible with respect to content and setting. In this~     study, patients who are in a slightly advanced rehabilitation process, assessed via their~     function profile, are investigated.~   "
73887|NCT02599753|"~     The objective of this protocol is to investigate the microstructural alterations and~     monoaminergic function in Parkinson's disease patients with impulse control disorders and~     cognitive impairment by multimodal MRI and 18F-DTBZ PET imaging.~   "
73888|NCT02599740|"~     This study is designed to test bioequivalence of a assumed key active compound vs. natural~     fruit extract as judged from the Incremental area under the curve (+iAUC0-2h) for blood~     glucose: i.e. the 90% confidence interval of the ratio +iAUC0-2h for blood glucose for~     assumed key active compound vs. natural extract falls between 0.8 - 1.25.~   "
73877|NCT02599883|"~     Background: Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of~     chronic morbidity and mortality worldwide. There is debate about diagnosis and management of~     COPD because it was described as complex syndrome accounting for various pulmonary and~     extrapulmonary abnormalities. As a result, there is consensus that both clinical evaluation~     and pulmonary function tests (PFTs) data by themselves do not adequately describe the~     complexity of the disease. The chest radiograph is the sole imaging examination recommended~     for the routine evaluation of these patients by the physicians guidelines (GOLD~     guidelines),which, however, are also debating on the utility of computed tomography (CT) in~     this setting. Indeed, a number of studies reported a dramatic increasing use of CT of the~     chest for COPD assessment, in both clinical and research settings. COPD assessment by CT~     seems to improve the accuracy and completeness of the clinical evaluation of these patients.~     Nevertheless, the clinical utility of CT has yet to be proved by prospective studies or~     defined by guidelines.~      Objectives: To evaluate the change in the diagnosis and management of COPD when multiple~     CT-derived information is added to pre-test evaluation.~      Methods: Four pulmonologists with various expertise in the field will review clinical data,~     PFTs results, and chest radiographs of 200 consecutive COPD patients diagnosed according to~     current guidelines. Therefore, after two months from the first evaluation, the pulmonologists~     will review the clinical and PFTs records with comprehensive information about low-dose CT~     (LDCT) previously performed in a week from the chest radiograph. Information about LDCT~     findings will include qualitative assessment by an experienced chest radiologist and~     quantitative analysis by means of an innovative 3D imaging dedicated software. Phenotype~     assessment and patient care decisions (e.g. therapeutic and follow-up strategies, need of~     additional tests etc.) will be recorded before and after assimilation of LDCT data.~      Expected results: This evidence-based prospective study will test the impact of chest LDCT on~     management of COPD patient. In addition, the level of agreement between pulmonologists in~     terms of diagnosis and therapeutic strategies will be assessed. Furthermore, the study will~     evaluate the need for additional tests referable to LDCT information and their impact on the~     health care system (e.g. in terms of additional costs).~   "
73878|NCT02599870|"~     The purpose of this study is to evaluate the effect of pharmacogenetic (PGx) guided treatment~     when implemented into the pre-operative process for patients undergoing an elective spinal~     surgical procedure and requiring post-operative acute pain management, as compared to a group~     of subjects with the same attributes without the guidance of PGx testing for their~     post-surgery pain management. This study will also evaluate whether PGx testing can reduce~     narcotic consumption, opioid-related adverse effects, time to mobilization, medical visits~     and costs.~   "
73879|NCT02599857|"~     Life expectancy of children with congenital heart disease (CHD) has increased dramatically~     during the past years, due to the successes of cardiac surgery. Nearly all of these children~     with CHD can be operated at young age and more than 90% reach adulthood. However, many adults~     with CHD are life-long affected by cardiac events, particularly arrhythmias and heart~     failure, putting them at risk of premature death. These events have a large impact on quality~     of life of patients and their families and merit life-long hospital visits in a medical~     center specialized in adult CHD. Especially for adults with CHD patient care with a~     smartphone is suited because of their young age and chronic condition. So far, data are~     lacking on smartphone interventions in patients with CHD.~   "
73880|NCT02599844|"~     Sepsis is the most common cause of childhood death worldwide. Millions of children survive,~     but are left with impaired health. Sepsis-related Acute Kidney Injury (sAKI) is increasingly~     recognized as a significant factor associated with long-term mortality among different~     patient populations. Renal dysfunction and subsequent chronic kidney disease is implicated in~     the development of hypertension and cardiovascular disease. The investigators overall~     hypothesis is that, in the pediatric population, sepsis-related AKI will have unrecognized,~     long-term consequences with regard to kidney function, endothelial function, blood pressure~     control, and overall health.~   "
73881|NCT02599831|"~     The purpose of this study is to determine whether electrical pudendal nerve stimulation is~     more effective than pelvic floor muscle training plus transanal electrical stimulation in~     treating post prostatectomy Incontinence.~   "
73882|NCT02599818|"~     This study will examine the clinical effectiveness and health economic profile of services to~     link hospital patients with substance use disorders to addiction treatment, promote their~     medical stabilization, and reduce hospital re-admissions.~   "
73883|NCT02599805|"~     Diabetic foot complications care represent a significant burden to the Canadian healthcare~     system. The estimated annual expenditure in Canada for diabetic foot ulcers is more than $150~     million. A small sized randomized controlled trial (n=17) investigating the use of topical~     oxygen therapy (n=9) against placebo (n=8) for diabetic ulcers was done recently and showed a~     87% average reduction of ulcer size in treatment group versus 46% average reduction in the~     control group (p<0.05).~      Despite the standards of care used today in diabetic foot ulcer treatment, wounds may be~     non-healing when they do not heal within the appropriate time frame expected by an~     experienced clinician. Current diabetic foot ulcer standards of care include: full medical~     assessment in all cases, surgical intervention where indicated and local treatment of the~     ulcer.~      Given the scarcity of controlled trials specifically designed to review the effects of~     topical oxygen in ulcer care, this study will contribute to the understanding of the~     management of these ulcers by assessing the reductions in ulcer size achieved using Natrox™~     topical oxygen therapy.~   "
73884|NCT02599792|"~     Two-part study to assess CTP-656 dosed as a solid oral dosage form versus Kalydeco and~     multiple-ascending doses of CTP-656 dosed for 7 days.~   "
73885|NCT02599779|"~     This study is designed as a phase-II proof of concept trial to investigate if a treatment~     strategy where stereotactic body radiation therapy (SBRT) is given with pembrolizumab is~     sufficiently active to warrant further investigation in randomized phase II or III studies.~     Metastatic renal cell cancer (mRCC) patients with PD-1 expressing immune cells are more~     likely to have larger more aggressive tumours and reduced survival and renal tumours that~     express PD-L1 are more aggressive with poorer outcome. Blocking this receptor/ligand~     interaction with monoclonal antibodies can restore the activity of tumour specific T-cells~     within the tumour with durable responses documented in early clinical trials in several~     tumour types including renal cell carcinoma. The study drug pembrolizumab is designed to~     directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. SBRT will be~     given to the 1-3 most clinically significant lesions at the time of progression on~     pembrolizumab or at the 2nd course of pembrolizumab treatment in an effort to improve the~     activity of pembrolizumab. A total of 35 patients refractory to the approved first line~     therapy with a targeted drug (Sunitinib or Pazopanib) or untreated RCC patients with~     sarcomatoid differentiation will be enrolled on study. This group of patient has a poor~     outcome on any other 2nd line therapy and urgently need novel therapy.~   "
73889|NCT02599727|"~     Determine the effects repeated isometric exercises have on balance, blood pressure, heart~     rate and pulse ox. Another outcome measure will be a mental speed test (how quickly a subject~     can process information and make decisions based upon that information).~   "
73894|NCT02599662|"~     Currently, for patients with pancreatic cancer the standard treatment is surgery followed by~     chemotherapy and/or radiation therapy. An investigational approach is to perform the surgery~     and treat the area of the tumor with intraoperative radiotherapy in one procedure.~     Intraoperative radiation delivers low energy x-rays to a targeted area during the time of~     tumor removal.~      The purpose of this study is to learn about both the good and bad effects of adding~     intraoperative radiation therapy. Another goal is to determine and compare the quality of~     life before and after the procedure. We will also monitor the effect of the therapy on the~     cancer lesion and any complications that may result.~   "
73895|NCT02599649|"~     The goal of this clinical research study is to learn if lirilumab and Opdivo (nivolumab),~     alone or in combination with Vidaza (azacitidine), can help to control MDS. The safety of~     these drug combinations will also be studied.~      This is an investigational study. Lirilumab is not FDA approved or commercially available. It~     is currently being used for research purposes. Nivolumab is FDA approved and commercially~     available for the treatment of melanoma and non small cell lung cancer (NSCLC). Azacitidine~     is FDA approved and commercially available for the treatment of MDS. The study doctor can~     explain how the study drugs are designed to work.~      Up to 80 participants will be enrolled in this study. All will take part at MD Anderson.~   "
73896|NCT02599636|"~     Many factors before and after ICU stay determine the outcome of patients at ICU discharge,~     the type of illness, physical dependence and other sequelae can be a trigger for~     complications in hospital ward which can induce ICU readmission and worse outcome. The~     quality of medical assistance during all the hospitalisation should be guaranteed and many~     complications or fatal events could be avoidable.~      The objective of the present study is to demonstrate that collaboration between the~     intensivist and other medical teams in ward can reduce ICU readmission and hospital mortality~     after ICU discharge.~   "
73897|NCT02599623|"~     This prospective randomized is designed to evaluate the safety and efficacy of hernia repairs~     using local anesthesia compared with those using general anesthesia for patients with~     incarcerated hernia.~   "
73898|NCT02599610|"~     Digital vaginal examination is the most common method for assessing progress of labor and~     delivery. Considering it is the most common intervention women receive during course of~     labor, evidence for psychological effects of digital vaginal examination on women is~     surprisingly sparse. Reducing the number of vaginal examination during labor has been~     proposed by many authors as benefit of more vaginal examination is unclear. However this is~     unlikely to happen until more research on the topic demonstrates clear detrimental effects of~     vaginal examination.~      Our study is aimed at investigating association of vaginal examination with psychological~     distress of women during labor. Anxiety during labor is associated with longer labor~     duration, increased perception of pain, problems with newborn attachment, and increased rates~     of postpartum depression and post-traumatic stress disorder. In this study, women were~     assigned to either digital vaginal examination or transperineal ultrasound assessment groups~     were compared to each other in a randomised controlled setting.~   "
73899|NCT02599597|"~     Depression treatments including physical activity and sleep management has been shown to~     relieve depressive symptoms among participants suffering depressive episodes. This study~     evaluates the potential of these methods as prevention of depressive relapse or recurrence~   "
73900|NCT02599584|"~     Simulated environment allowed safe learning of critical events and knowledge of appropriate~     response and treatment. Anesthesiology resident education curriculum in Lyon plans several~     high fidelity simulation session with a large panel of critical events. Anticipation of~     critical events before they may occur and plannification of team resources and priority in~     the treatment strategy may help to improve team performance during the scenario. The~     investigators' goal is to compare team performance during the scenario with or without a~     liberal preparation team staff of 4 min, suggested after the briefing of the scenario but~     before the scenario starts.~   "
73901|NCT02599571|"~     The purpose of this study is to investigate the impact of different nicotine levels in~     cigarettes with individuals who have ADHD.~   "
73902|NCT02599558|"~     This study is being done to see if the investigators can use only the cytosponge ( A 10~     minute, in office procedure that does not require sedation) to replace the 6-10 endoscopies~     routinely perform during dietary restriction and food reintroduction in EoE?~   "
73903|NCT02599545|"~     Very low birth weight (VLBW) infants have more health and developmental problems than normal~     birth weight full-term infants. These problems are more common in males than female VLBW~     preterm infants. Male VLBW infants also experience less positive mother-infant interactions~     than females, especially when mothers are emotionally distressed. This is a significant~     problem because positive mother-infant interactions function as an important protective~     factor against the negative health and developmental outcomes associated with prematurity.~     The source of the vulnerability of male VLBW infants to health problems, suboptimal~     mother-infant interactions, and poor development goes beyond gender socialization differences~     and includes biological factors. Identification of infant and maternal biological~     markers/predictors of infant health and developmental outcomes could ultimately lead to~     interventions for VLBW preterm infants.~      The purpose of this study is to confirm that testosterone rather than cortisol is a more~     reliable marker/predictor of complications affecting infants' health outcomes, mother-infant~     interactions, and infant cognitive/motor/language developmental outcomes; and that male~     infants exhibit a higher sensitivity to testosterone levels than female infants.~      This longitudinal study will examine the associations of the steroid hormones, testosterone~     and cortisol, levels with infant health, mother-infant interactions, and infant~     cognitive/motor/language development ('infant development') in very low birthweight (VLBW, BW~     < 1,500 g) preterm (gestational age < 32 weeks gestation) infants after adjusting for~     maternal physical and mental health state, infant socioemotional and behavioral development,~     and characteristics of infants and mothers. Concurrent and repeated measurement of~     testosterone and cortisol levels both in infants and mothers will be conducted through~     infancy and early childhood (at birth, 40 weeks postmenstrual age, 12 and 24 months corrected~     age).~   "
73904|NCT02599532|"~     This study is to investigate the pharmacokinetics and pharmacodynamics of apixaban in~     nephrotic syndrome.~   "
73905|NCT02599506|"~     This pilot study concentrates on studying the trajectory of breast cancer patient's fear of~     recurrence (FoR) over the course of radiation therapy. The aim is to collect repeated ratings~     of 100 breast cancer patient's FoR over the course of their treatment. It is hypothesized~     that cancer patient's FoR level will rise on nearing the termination of the in radiotherapy~     treatment, and radiotherapist-patient interaction modifies the development of patient's FoR.~   "
73924|NCT02599259|"~     AiCure uses artificial intelligence and visual recognition technology to confirm medication~     ingestion. The software is available as an app and downloaded onto a smart phone. The~     single-site, parallel-arm, randomized controlled trial will test the feasibility and impact~     of using the platform in a stroke population. End points: usability, consistent use of the~     device, and optimization of treatment.~   "
73906|NCT02599493|"~     Rifampicin is an antibiotic usually required to treat susceptible Staphylococcus spp.~     osteo-articular infections, most frequently in association with a fluoroquinolone when the~     strain is susceptible to both agents. It is the reference treatment for orthopedic infections~     with implanted material.~      For tuberculosis treatment the dosage of 10 mg/kg/j is usually prescribed, while in the~     treatment of Staphylococcus spp. infections the highest dosage of 20 mg/kg/j is proposed by~     French experts' recommendations from 2009.~      However, there is little evidence in the literature, which could set out arguments to choose~     the best dosage of rifampicin, which may vary from 5 to 20 mg/kg.~      The issue with rifampicin is side effects, in particular with long-term treatment. Many side~     effects may occur in 10 to 20% of patients and sometimes leads to dosage reduction or~     treatment interruption.~      In the literature, there is little evidence that higher rifampicin dosage is associated with~     higher frequency of adverse effects. Depending on the nature of the toxicity, one could say~     that hypersensitivity could be independent from dosage, when digestive disorders may be~     related. Plasmatic concentrations studies have not given strong arguments to link higher~     rifampicin dosages with side effects occurrence rates. After oral absorption, plasmatic peak~     occurs after two to five hours and varies among individuals but also in the same patient~     overtime. This particular pharmacokinetic profile could explain discrepancy in adverse events~     (AEs) frequencies.~   "
73907|NCT02599480|"~     This study will assess the efficacy of mirabegron, a new beta3-adrenergic receptor in the~     prevention of heart failure. This is a two armed, prospective, randomized,~     placebo-controlled, multi-centric european phase IIb trial with placebo and mirabegron~     distributed in a 1:1 fashion. The patients enrolled will have cardiac structural remodeling~     with or without symptoms of heart failure (maximum NYHA II).~      Patients will be monitored for change in left ventricular mass (assessed by cardiac MRI)~     and/or changes in diastolic function (assessed by echocardiography) after 12 months of~     treatment.~   "
73908|NCT02599467|"~     Upper limb neural mechanosensitivity is a painful disturbance that breast cancer patients~     often undergo following axillary surgery. It is assessed by the upper limb neurodynamic test~     for the median nerve, called upper limb neurodynamic test 1 (ULNT1). Design: A matched~     case-control observational study. Objective: to check the increased upper limb~     mechanosensitivity by shoulder range of motion (ROM) during ULNT1 and to determine, for the~     first time, the evoked electromyographic (EMG) muscle activity. Participants: 62 cases who~     underwent breast cancer surgery and 64 matched control women. Setting: Torrejon Hospital,~     Physical Therapy Department, Madrid (Spain). Intervention: To record EMG muscle activity~     during ULNT1 performance and to measure shoulder ROM. Key outcomes: mechanosensitivity,~     breast cancer, pain, EMG, shoulder ROM, median nerve.~   "
73909|NCT02599454|"~     This phase I trial studies the side effects and best dose of atezolizumab that can be given~     together with stereotactic body radiation therapy in treating patients with stage I non-small~     cell lung cancer that cannot be removed by surgery. Monoclonal antibodies, such as~     atezolizumab, may interfere with the ability of tumor cells to grow and spread. Radiation~     therapy uses high energy x-rays to kill tumor cells and shrink tumors. Stereotactic body~     radiation therapy is a specialized radiation therapy that delivers a single, high dose of~     radiation directly to the tumor and may kill more tumor cells and cause less damage to normal~     tissue. Giving atezolizumab together with stereotactic body radiation therapy may kill more~     tumor cells and be a better treatment for non-small cell lung cancer that cannot be removed~     by surgery.~   "
73910|NCT02599441|"~     To compare measures of ankle stability from an investigational cone beam computed tomography~     scanner to gravity stress X-ray in patients who have unstable supination-external rotation~     ankle fractures.~   "
73911|NCT02599428|"~     This project aims to investigate the physical, mental and cognitive recovery after admission~     to the Intensive Care Unit (ICU).~      This will be done by a three and 12 month follow up after discharge. The patients will be~     scored with four validated methods for evaluating their health related quality of life,~     anxiety and depression, cognitive function and physical impairments~   "
73912|NCT02599415|"~     This is a pilot study to investigate the effect of TL01 narrow band UVB therapy on the~     resident dermal dendritic cells characterized by expression of CD1c and CD141. These cells~     were reported to have a role in induction of tolerogenic regulatory T cells and production of~     IL-10. The investigators proposed to investigate the effect of NB-UVB on these subsets of~     cells after two weeks of treatment to provide better understanding of the mechanism of action~     of light treatment.~   "
73913|NCT02599402|"~     The purpose of this study is to determine the effects of combination treatment of Nivolumab~     with Ipilimumab followed by Nivolumab monotherapy in patients with previously untreated~     advanced Melanoma.~   "
73914|NCT02599389|"~     The aim of this multicenter triple-arm randomized study is to compare two innovative~     techniques with the gold standard currently used and providing unsatisfactory results for the~     In-Stent Restenosis (ISR) treatment in femoro-popliteal arteries. This protocol compares the~     use of drug-coated balloons (paclitaxel - antimitotic) used alone or in association with the~     Excimer Laser to recalibrate the vessel lumen into the stent by destroying the whole fibrous~     material to the standard angioplasty using plain balloons. INTACT study main objective is to~     assess cost-effectiveness ratio of the treatment of femoropopliteal artery in-stent~     restenosis by comparing these two innovative strategies and the standard one in terms of cost~     per Qaly (Quality adjusted life-years) gained at 18 months from a collective perspective.~   "
73925|NCT02599246|"~     The purpose of this study is to compare pharyngeal FiO2 in day time with nasal normobaric O2~     with inhaled FiO2 in the night time with home care ventilator NIV at the same O2 flow.~   "
73926|NCT02599233|"~     The main objective of this study is to establish the postoperative pain pathways observed~     from D1 to D7 in the context of the current management after orthopedic, digestive,~     obstetrics and gynecology, urology, neurosurgery, vascular and thoracicn surgeries.~   "
73927|NCT02599220|"~     This study examines the clinical outcomes and healthcare costs associated with gram negative~     bacteremia at Duke University Medical Center from 2002-2015.~   "
74006|NCT02598193|"~     This clinical study will evaluate the safety and tolerability of combination treatment of~     nintedanib and pirfenidone in participants with IPF. Eligible participants must have received~     pirfenidone for at least 16 weeks on a stable dose. Nintedanib will be added on Day 1 of the~     study as a combination treatment for IPF for 24 weeks.~   "
73915|NCT02599376|"~     Obesity has become one of the most common risk factors in obstetric practice with serious~     anaesthetic implications. Obese pregnants have limited physiological reserves and~     cardiovascular co- morbidities when compared to non-obese pregnant women. Spinal anaesthesia~     is the anaesthetic technique of choice for caesarean section. The haemodynamic changes~     associated with spinal anaesthesia pose the greatest hazard to the mother and the foetus and~     are exaggerated in obese pregnant women. However differences in the changes in haemodynamic~     variables such as cardiac output (CO), stroke volume (SV) and systemic vascular resistance~     (SVR) between obese and non-obese pregnant women having caesarean section (CS) under spinal~     anaesthesia have not been studied before. This study compares the haemodynamic changes after~     spinal anaesthesia for CS in non-obese and obese parturients in a single centre, prospective~     case control study, using LiDCOrapidV2. This LiDCOrapidV2 device is a noninvasive method of~     measuring haemodynamic variables. It is a single centre, prospective, case control study. The~     primary outcome compares the differences and variability in CO, SV and SVR between obese and~     non-obese parturients. The secondary outcomes include comparison of the correlation between~     changes in blood pressure (BP) and CO in each patient and the difference in BP between~     conventional intermittent oscillometric device and continuous LiDCORapidV2in each patient~     with a view to assess the need for measurement of cardiac output in obstetric anaesthesia~   "
73916|NCT02599363|"~     This is a Phase I study to assess the safety and MTD of paclitaxel + ribociclib (LEE011) in~     patients with Rb+, advanced breast cancer. Dose escalation will be performed using standard 3~     + 3 dosing strategy. The starting dose of ribociclib (LEE011) is 200 mg once daily; dose~     escalation proceeds in 200 mg increments up to a maximum of 600 mg. Dose-limiting toxicities~     (DLT) will be based upon first-cycle toxicity.~   "
73917|NCT02599350|"~     In an attempt to standardise the degree of impairment of gas exchange in the lungs of ICU~     patients a number of indices of oxygen exchange have been developed. These include: the~     arterial−alveolar oxygen tension ratio (a/APO2), the arterial oxygen tension−inspired oxygen~     concentration ratio (PaO2/FIO2), the respiratory index (RI), [A−a)DO2/PaO2) and the~     alveolar−arterial oxygen tension difference [A−a)DO2). These are used clinically despite the~     fact that they do not accurately predict gas exchange particularly with changing the amount~     of inspired oxygen or when there is mixing of oxygenated blood with unoxygenated blood in the~     patient (called shunt). None of the indices reliably reflect the behaviour of the~     physiological shunt. In a pilot study as inspired oxygen (FIO2) was increased incrementally~     from 0.30 to 1.00, up to 55 per cent of the measured changes in these indices were opposite~     in direction to the corresponding changes in the physiological shunt. The investigators have~     developed a computer algorithm and a slide rule to try and improve on these clinical~     measures. The investigators wish to test their slide rule on ventilated patients by altering~     the inspired oxygen to see if it will predict what the actual change in oxygen will be.~   "
73918|NCT02599337|"~     Randomized, open-label, 3-way reference replicated crossover bioequivalence study of~     sorafenib 200 mg tablet and nexavar (reference) following a 200 mg dose in healthy subjects~     under fasting conditions.~   "
73919|NCT02599324|"~     The purpose of this study is to evaluate the safety, tolerability, and efficacy of the~     combination treatment of ibrutinib with everolimus, paclitaxel, docetaxel, or cetuximab in~     selected advanced gastrointestinal and genitourinary tumors.~   "
73920|NCT02599311|"~     One thousand patients with stage＞2 POP are recruited. The patients are all received~     surgeries,such as transvaginal synthetic mesh surgery, the sacral fixation, tissue repair~     surgery and colpocleisis. The patients with POP who have not undergone surgery are excluded.~     Postoperatively, the investigators investigate the indications and clinical efficacy of~     pelvic organ prolapse surgery.~   "
73921|NCT02599298|"~     The aim of this randomized, open-label clinical trial is to determine the impact of Sleep~     Study-Guided Multidisciplinary Therapy (SGMT, i.e. continuous positive airway pressure and~     behavioral therapy) for obstructive sleep apnea (OSA) in the sub-acute phase of acute~     coronary syndrome on cardiovascular outcomes. We hypothesize that SGMT will result in a lower~     (1) plasma NT-pro BNP and ST2 levels, (2) 10-year risk of cardiovascular mortality based on~     the European SCORE algorithm, and (3) cardiovascular event rate, when compared with Standard~     Therapy.~      OSA is an emerging cardiac risk factor and prognostic marker. We have reported that OSA is a~     prevalent and independent predictor of adverse outcomes in patients with acute coronary~     syndrome. In this clinical trial, a continuation of my research and publication trajectory,~     180 patients presenting with acute coronary syndrome will be randomly assigned to SGMT (n=90)~     or Standard Therapy (n=90) groups. Both groups will receive guideline-mandated treatment for~     acute coronary syndrome. Those assigned to SGMT will undergo a sleep study. Those found to~     have OSA will attend the SGMT clinic run by a multidisciplinary team. Advice on continuous~     positive airway pressure and behavioral therapy (weight loss, exercise, positional therapy,~     abstinence of alcohol and sleeping pills) will be given. The primary endpoint is plasma~     NT-pro BNP concentration at 6-month follow-up. The secondary endpoint is 10-year risk of~     cardiovascular mortality based on the European SCORE algorithm which includes age, sex,~     smoking status, systolic blood pressure, and serum total cholesterol or total/HDL-cholesterol~     ratio. Adverse cardiovascular events at 3-year follow-up will be determined.~      In our aging population with an increasing prevalence of obesity, OSA will potentially become~     an increasingly important contributor to cardiovascular disease. Leveraging the collective~     expertise of a team of cardiologists and sleep physicians, our work will benefit society by~     advancing our understanding of the cardiovascular benefits of screening for and treating OSA.~   "
73922|NCT02599285|"~     In AO Weber type C fractures, there is a combination of a proximal fibular fracture, a medial~     fracture or ruptured deltoid ligament, and a syndesmotic injury. Anatomical repair and~     reduction of the syndesmosis is essential to prevent diastasis in the ankle-joint. Widening~     and chronical instability of the syndesmosis is related to worse functional outcome and~     development of posttraumatic osteoarthritis in the ankle. There is limited biomechanical and~     clinical evidence that syndesmotic stability in AO Weber type C fractures with an additional~     posterior malleolar fracture can also be reached by fixation of the posterior malleolar~     fragment. Maybe, this is even superior to the usual treatment with syndesmotic positioning~     screws. Some authors concluded that stability of the syndesmosis in these fractures can be~     much more achieved by fixation of the posterior malleolar fragment than by placement of~     syndesmotic positioning screws alone. Another additional benefit of open reduction and~     fixation of the posterior malleolar fragment is that this will lead to an anatomical~     reconstruction of the syndesmosis. Although there is no current evidence, it is likely that a~     malreduction of the fibula in the tibial incisura will lead to a worse functional outcome on~     the long-term. No clear consensus in the literature is found as to which fragment size of the~     posterior malleolus should be internally fixed. The general opinion is that displaced~     fragments that involve more than 25% of the distal articular tibia should be fixed.~     Traditionally, reduction of these larger fragments is indirectly, followed by percutaneous~     screw fixation in anterior-posterior direction. Disadvantages are that it is hard to achieve~     an anatomical reduction, and that percutaneous fixation of smaller fragments is very~     difficult. Recently, a direct exposure of the posterior tibia via a posterolateral approach~     in prone position, followed by open reduction and fixation with screws in posterior-anterior~     direction or antiglide plate is advocated by several authors. This approach allows perfect~     visualization of the fracture, articular anatomical reduction, and strong fixation. Another~     advantage is that even small posterior fragments can be addressed. Several case series are~     published, which describe minimal major wound complications, good functional outcomes, and~     minimal need for reoperation.~   "
73923|NCT02599272|"~     The study will investigate whether having mixed spices rich in polyphenols can improve~     postprandial cardiometabolic response in healthy Chinese men.~   "
74007|NCT02598180|"~     Vergenix Flowable Gel is indicated for the management of acute and chronic wounds~   "
73928|NCT02599207|"~     This study is a single site, phase I, prospective study of the safety of intravenous sibling~     cord blood infusion in 15 children ages 1-6 years with Cerebral Palsy (CP). All subjects will~     be treated with sibling cord blood cells. The first six will receive cord blood cells from an~     HLA-matched sibling. The following nine subjects will receive cord blood cells from an~     HLA-mismatched (≥3/6 match) or matched sibling. The duration of study participation will be~     six months from the time of the cord blood infusion.~   "
73929|NCT02599194|"~     The goal of this Phase II clinical trial is to further evaluate the ability of 18F-FSPG to~     diagnose, prognosticate, and evaluate response to therapy in patients with a wide variety of~     metastatic cancers.~   "
73930|NCT02599181|"~     The aim of this study was to investigate the influence of alcoholic skin disin-fection before~     PNC (perineural catheter)-removal on the detection of bacteria on the subcutaneous part of~     the PNC or on the tip. Furthermore, the correlation of bacterial colonization with~     PNC-associated local inflammation or infection was evaluated.~   "
73931|NCT02599168|"~     Dexmedetomidine, a selective alpha-2 agonist agent used for maintaining sedation in intensive~     care patients in receipt of mechanical ventilation, is being increasingly utilized in~     anaesthesia practice for facilitating anaesthesia depth as an adjunct to base anaesthetics~     (intravenous; propofol: inhalational; sevoflurane, desflurane). The investigators intend to~     assess the anaesthetic potential of dexmedetomidine in controlled anaesthesia settings~     empowered by the use of an objective, patient response based, safe, efficient, and patented~     closed loop anaesthesia delivery system (CLADS). CLADS functions on control of processed EEG~     response parameter captured from anaesthetized patients with the help of a BIS- monitor,~     which is continuously fed into a automated drug infusion pump. The infusion pump then~     accordingly delivers the anaesthetic drug to the patients based on pharmacodynamic~     requirements. If dexmedetomidine has anaesthesia potential then it is likely that propofol~     use delivered by CLADS can be reduced further. In addition the effect of two drugs (viz, base~     agent-propofol plus adjunct agent-dexmedetomidine) on different receptor site within the~     brain would help gain greater anaesthetic depth consistency as well as a lower incidence of~     intraoperative patient awareness. This prospective randomized two-arm study aims to assess~     effect of the use of dexmedetomidine on propofol requirements (primary objective),~     anaesthesia depth consistency, and intraoperative patient awareness (secondary objectives).~   "
73932|NCT02599155|"~     The investigator will evaluate the influence of colloid administration on postoperative acute~     kidney injury in pediatric patients undergoing cardiac surgery under cardiopulmonary bypass.~   "
73933|NCT02599142|"~     Patients having radiotherapy to their head and neck wear an immobilisation shell to prevent~     patient movement and improve treatment accuracy. These shells tend to cover the face and have~     the potential to cause anxiety and distress in patients, particularly if they suffer with~     claustrophobia or a similar fear. The study will use an 'open-face' shell that does not cover~     the face and compare this with the investigators' current 'closed-face' shell. The~     investigators will obtain treatment verification x-ray images to assess the daily set-up~     errors and compare these between the two shell type, and ask both patients and radiographers~     of their experiences from using the shells.~      Hypothesis: Open-face immobilisation shells offer equivalent accuracy and efficiency of~     radiotherapy delivery and are better accepted by patients and radiographers as compared to~     closed-face immobilisation shells for cranial radiotherapy.~   "
73934|NCT02599129|"~     Alopecia areata is a medical condition, in which the hair falls out in patches. The hair can~     fall out on the scalp or elsewhere on the face and body.~      Alopecia areata is an autoimmune skin disease, which means that the immune system is~     recognizing the hair follicles as foreign and attacking them, causing round patches of hair~     loss. It can progress to total scalp hair loss (alopecia totalis) or complete body hair loss~     (alopecia universalis). The scalp is the most commonly affected area, but the beard or any~     hair-bearing site can be affected alone or together with the scalp. Alopecia areata occurs in~     males and females of all ages, and is a highly unpredictable condition that tends to recur.~     Alopecia areata can cause significant distress to both patients and their families.~      Aim: To assess the effects of a new treatment called secukinumab in patients with alopecia~     areata. A total of 30 patients will be included in the study, which will run for a total of~     28 weeks.~   "
73935|NCT02599116|"~     This study analyzes the gastrointestinal microbiome of appendiceal cancer patients with~     peritoneal spread scheduled to undergo cytoreductive surgery with hyperthermic~     intraperitoneal chemotherapy (CRS/HIPEC). Participants will provide fecal samples pre- and~     post-operatively.~   "
73936|NCT02599103|"~     Fats and oils play important roles in maintaining human nutrition and health through~     providing energy, essential fatty acids, and acting as modulators of many biological~     processes (signal transduction, immunity and inflammation). Due to differences in the fatty~     acid composition and content of antioxidants of individual cooking oils, the degree of~     oxidative and thermolytic reactions may vary oil by oil. It is lack of human feeding study to~     investigate the molecular mechanisms on how and which deep-fried oil exerts its adverse~     effects. The investigators are also lack of biomarkers for monitoring deep-fried oil~     exposure. Therefore, the purpose of this study is to compare how human body responds~     differently to several popular uncooked and deep-fried oils with varied fatty acid~     compositions with respect of oxylipin profile, inflammatory markers, non-targeted~     metabolomics, and transcriptomics. The investigators will recruit 20 volunteers, provided~     them once a week the milk shakes prepared from 60g of olive oil, soybean oil, palm oil,~     camellia oil, tallow (butter), and deep-fried oils of the last 4, respectively; in comparison~     with a no-fat milk shake control. The experiments lasted for 10 weeks.。Each time; serum,~     plasma, whole blood and urine samples were collected at baseline, after 2 hours, and after 4~     hours. The investigators anticipate to find biomarker(s) for deep-frying, and contribute to~     the understanding of molecular mechanisms on how deep-fried oils exert adverse effects toward~     health through integrative omics or so-called system biology approaches.~   "
73937|NCT02599090|"~     The goal of this clinical research study is to find the highest tolerable dose of sorafenib~     that can be given in combination with temozolomide. The safety of this combination will also~     be studied.~   "
74008|NCT02598167|"~     This multi-center non-interventional, observational, cross-sectional study in adult~     participants with relapsing remitting multiple sclerosis (RRMS) will evaluate the~     participants' preferences for disease modifying treatments (DMT) in routine clinical~     practice.~   "
73938|NCT02599077|"~     Project Summary Endometriosis is a disease with a high prevalence that primarily affects~     women of childbearing age. This condition brings an important physical and emotional burden~     on sufferers and this is why it requires proper and timely medical management. At present~     there are several first-line drugs available for the management of symptoms and disease~     control. In the world literature we have reported several studies that demonstrate the~     effectiveness of different groups of drugs such as oral contraceptives, progestins, GnRH~     analogues and danazol. Within the available scientific evidence it has been extensively~     described the benefits of the new progestins Dienogest, demonstrating a favorable safety~     profile and efficacy along with a significant reduction of the symptoms of the disease by its~     anti-inflammatory, and antiproliferative antiagiogénicas in the endometrial tissue . However,~     although the therapeutic properties of this drug are known, studies are needed to compare its~     effectiveness with the effectiveness of other therapeutic agents as oral contraceptives. That~     is why the main objective of this study is to evaluate the impact of Dienogest to 2 mg / day~     compared with a combined oral contraceptive (levonorgestrel + ethinyl estradiol) in the size~     of the endometriomas diagnosed by transvaginal ultrasonography in 50 women having diameters~     less than 4 centimeters of the same, which medical management will be given for one year at~     the University Hospital Fundación Santa Fe de Bogota. The study was conducted by a clinical~     trial, randomized, single-blind by the observer. The results will be analyzed and the~     findings in the study will serve as a tool to define new therapeutic conduct in the~     management of endometriosis.~   "
73939|NCT02599064|"~     This study is designed to evaluate the safety, tolerability and clinical activity of RXI-109~     administered by intravitreal injection to reduce the progression of subretinal fibrosis in~     subjects with advanced neovascular age-related macular degeneration (NVAMD).~   "
73940|NCT02599051|"~     A randomized control trial to compare the efficacy of the single incision mini-sling to the~     transobturator sling~   "
73941|NCT02599038|"~     In this study, the investigators aim to increase the liver tissue level of GSH in NAFLD~     patients by short-term dietary serine supplementation and improve their liver function by~     lowering the oxidative stress resulting from hepatic steatosis.~   "
73942|NCT02599025|"~     The investigators will examine the immediate contribution of position and movement on the~     functioning of the autonomic cardiac control system.~   "
73943|NCT02599012|"~     -  Multifactorial pathogenesis is involved in anemia of cancer patients and defining the~          causes of anemia is not always simple.~        -  Currently, treatment options available for anemia in cancer patients include red blood~          cell (RBC) transfusion, erythropoietin stimulating agent (ESA), and iron~          supplementation, accompanying considerable pros and cons for each treatment.~        -  Previous studies have demonstrated benefit when treating with IV iron in combination~          with ESA and, more recently, evidence is emerging to suggest a role for IV iron alone.~        -  In this study, investigator will assess the efficacy of intravenous iron for the~          treatment of anemia in cancer patients.~   "
73944|NCT02598999|"~     This is a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety,~     tolerability and pharmacokinetics of a single ascending doses (SAD) and multiple ascending~     doses (MAD) of Hypothiocyanite (OSCN-), bovine lactoferrin (bLF) and their combination~     (ALX-009) in healthy male volunteers and patients suffering from cystic fibrosis.~   "
73945|NCT02598986|"~     Glycemic index (GI) of food is known to be positively associated with the development of~     several diseases including type 2 diabetes, cardiovascular disease and age-related macular~     degeneration. Modest dietary changes from high-GI foods to low-GI foods have shown beneficial~     effects. These findings have been translated to recommendations for increased dietary intake~     of whole grains. However, the inverse relationship between whole grain consumption and risk~     of the different components of metabolic syndrome has not been explained by their fiber~     content. Trials of added cereal fiber have failed to induce a protective effect and fiber has~     thus been proposed to be a marker of other components of whole grains that impart health~     advantages. Whole wheat grains are known to be a rich source of several minerals (phosphorus,~     potassium and magnesium) that play a role in glucose metabolism, and are depleted during the~     process of refinement. Thus, it is plausible to hypothesize that the benefits of whole grains~     previously ascribed to their fiber content are in fact due to these minerals. The proposed~     research aims to restore or fortify white bread with these minerals and determine the~     resulting glycemic index of mineral-fortified bread. With much evidence that most people~     prefer the taste and color of white bread, a low GI, mineral fortified white bread has the~     potential to reduce the risk of Metabolic Syndrome in those who consume it.~   "
73946|NCT02598973|"~     Parkinson's disease (PD) is a common neurodegenerative disorder affecting approximately~     80,000 Veterans, representing a priority area for VA research. Current medicines for PD only~     improve symptoms, treatments that slow disease progression are needed, and earlier diagnosis~     of PD may be the key to their development. PD symptoms can be mimicked by medicines (most~     commonly antipsychotic drugs that block dopamine), and some of these patients actually have~     underlying prodromal PD that was unmasked years before it would have caused symptoms.~     This problem is increasing as these medicines are now used for common conditions including~     post-traumatic stress disorder and depression. The investigators will identify prodromal PD~     in patients with drug-induced symptoms using brain scans. These patients will be enrolled in~     a randomized clinical trial of aerobic exercise which slows progression in animal models of~     PD and has other health benefits. The investigators will measure the effect of exercise on~     symptoms, disease progression (using brain scans) and markers of PD risk (using blood tests).~     These studies will improve early PD diagnosis and potentially identify a way to slow~     progression of PD.~   "
73947|NCT02598960|"~     The purpose of this study is to evaluate the safety and tumor-shrinking ability of~     experimental medication BMS-986156, when given by itself or in combination with nivolumab in~     patients with solid cancers that are advanced or cancers that have spread.~   "
73957|NCT02598830|"~     This study evaluates the effect of vitamin D supplementation on outcomes of 10 weeks~     progressive strength training in 100 ageing subjects (>45 years of age). Participants will be~     recruited into two similarly sized strata; one containing COPD patients and one containing~     healthy subjects of similar age. In each stratum, half the participants will receive vitamin~     D supplementation and half the participants will receive placebo~   "
73948|NCT02598947|"~     Shoulder impingement syndrome is a very common cause of shoulder pain and normally treated~     with physiotherapy or surgery. Research has shown that physiotherapy is as effective as~     surgery, however, the incidence of surgery for this condition is on the rise internationally,~     nationally and locally. The most effective form of physiotherapy, however, is not known.~     Laboratory studies have suggested that posterior shoulder tightness may contribute to~     irritation of the soft tissue around the shoulder joint and perpetuate pain from shoulder~     impingement syndrome. There is a lack of good quality evidence to support this perspective.~     The aim of this study is to assess the feasibility of conducting a randomized controlled~     trial to evaluate the effectiveness of treatment for posterior shoulder tightness in~     combination with 'best care' compared with 'best care' alone in individuals with shoulder~     impingement syndrome.~      The study will be a randomised, controlled, double blind (patient and assessor), parallel~     group, feasibility study with 1:1 allocation ratio. Patients awaiting surgery will be~     assessed for inclusion/exclusion criteria and then randomly allocated into one of two groups.~     60 patients will be assigned to receive 'best care' physiotherapy, with or without treatment~     for posterior shoulder tightness.~      Physiotherapy treatment will be delivered over 13-15 weeks and outcomes will be assessed at~     0, 6-8, 13-15, 26 and 52 weeks. The results will help us to understand if this is an~     important part of physiotherapy treatment, which might help reduce patient's pain and~     disability as well as reduce the cost of treatment for the National Health Service.~   "
73949|NCT02598934|"~     This study will evaluate whether an early positive response to once-monthly oral ibandronate~     in treatment-naive participants with postmenopausal osteoporosis is predictive of efficacy~     later in treatment. The anticipated time on study treatment is 6 months, and the target~     sample size is 360 individuals.~   "
73950|NCT02598921|"~     Evaluation of the endometrial cavity is an important step in the infertility work-up,~     particularly if assisted reproductive therapy is planned. The aim is to identify possible~     endometrial abnormalities that may impair implantation.Undiagnosed endometrial abnormalities~     are present in 11 to 45% of women scheduled for in vitro fertilization (IVF).Traditionally,~     two dimensional transvaginal ultrasound (2D TVUS) and hysterosalpingography (HSG) are the~     basic methods for assessment of the endometrial cavity. However, these imaging modalities~     have shown high false negative rates among infertile women, a finding that could confine~     their rule to initial screening rather than definite diagnosis.~      Office hysteroscopy (OH) is the gold standard for evaluation of the endometrial cavity.~     Although the endoscopic approach has been proven to increase pregnancy rate in women who~     experienced prior implantation failure, evidence on treatment of unsuspected~     hysteroscopically-diagnosed endometrial lesions, to improve IVF outcome, is still lacking.~     Nevertheless,clinicians tend to use OH routinely prior to IVF because the psychological and~     financial burden that infertile couples may experience as a consequence of failed IVF cycle~     is unjustifiable.Yet, costs and invasiveness of OH counteract its global implementation to~     all women prior to IVF.~   "
73951|NCT02598908|"~     Participation in EQA schemes, where available, is mandatory for the United Kingdom~     Accreditation Service (UKAS). No EQA scheme currently exists for TPMT and thiopurine~     metabolites, which is a potential shortcoming of these tests. A pilot of this project has~     been awarded funding by Clinical Pathology Accreditation (CPA).~      The purpose of this work is to collect samples for an EQA scheme for whole blood TPMT~     (activity and genotype) and thiopurine metabolites, which will be run in collaboration with~     UK NEQAS (United Kingdom National External Quality Assessment Service), and facilitate a~     comprehensive world-wide service that enables laboratories providing these tests to fulfil~     quality goals and ultimately provide optimal patient care.~   "
73952|NCT02598895|"~     This pilot clinical trial studies docetaxel and carboplatin in treating patients with~     castration resistant prostate cancer that has spread from the primary site (place where it~     started) to other places in the body (metastatic) and contains inactivated genes in the BRCA~     1/2 pathway. Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading.~   "
73953|NCT02598882|"~     Assessment of energy expenditure and the quadriceps muscle fatigue of healthy seniors, after~     two physical activities, being one of an activity guided by interactive video game (Xbox) and~     another on the treadmill. The participants will perform the activities in two different days,~     the order will be obtained by randomization.~   "
73954|NCT02598869|"~     Macular edema is the most common sight threatening complication of uveitis which can lead to~     permanent loss of central vision. Triamcinolone acetonide ( the study drug)injection for~     treatment of cystoid macular edema(CME) is well established. The purpose of this study is to~     compare the safety and efficacy of injecting the study drug inside the eye(intravitreal~     injection) and behind the eye(subtenon injection)~   "
73955|NCT02598856|"~     Opioid overdoses have in the last decade counted for about 230 untimely deaths annually in~     Norway. The government is currently implementing a strategy for combating this epidemic.~     Among the actions promoted in this strategy is the distribution of naloxone for intranasal~     administration. Such administration of naloxone is currently being implemented and tried out~     around the world, but very little has been done to pharmacologically study this new route of~     administration of this well known drug, and only 3 open label randomized controlled trials~     (RCTs) have been conducted. A recent guideline from the WHO on community management of opioid~     overdoses is a comprehensive review of many of the aspects the investigators cover in our~     research.~      Regarding both dosage, routes of administration of naloxone and care of these patients in the~     pre hospital setting. The WHO calls for nasal formulations with a higher concentration, as~     well as focuses on the current wide spread off label use of nasal naloxone as a problem and~     identifies several research questions of critical importance and very low evidence.The~     current study, together with our research group's previous and future studies, aims to~     provide data for the development of a medicinal product with marketing authorisation for use~     in pre-hospital overdoses. This to contribute to public health measures for opioid users and~     those around them.~   "
73956|NCT02598843|"~     The purpose of this study is to directly compare traditional plaster treatment with early~     weightbearing in a walking boot for the non operative treatment of acute achilles tendon~     rupture.~   "
73963|NCT02598752|"~     The purpose of this study is to see if exercise fitness testing is feasible and safe in~     persons over 21 years of age who have been diagnosed with a hematological malignancy and are~     scheduled to undergo a hematopoietic stem cell transplant (HCT). Assessments in this study~     will look at the capacity of the body before transplantation to see if these measures can~     help predict how patients do after transplant.~   "
73964|NCT02598739|"~     The aim of this study was to assess the effectiveness of resistance training in improving~     functional capacity, muscle strength, quality of life and disease activity in patients with~     PSA.~   "
73965|NCT02598726|"~     This pilot phase I trial studies the side effects and best dose of curcumin when given~     together with piperine (piperine extract [standardized]) in reducing inflammation for~     ureteral stent-induced symptoms in patients with cancer. Curcumin is a spice similar to~     turmeric and works by decreasing the chemical moderators that produce inflammation in the~     body. Piperine is pepper and works by increasing the amount of curcumin available in the body~     when taken with curcumin. Giving curcumin together with piperine may reduce inflammation and~     discomfort from a ureteric stent in older patients with cancer.~   "
73966|NCT02598713|"~     The goal of this interventional study is to test Quinine as marker of aspiration~     (endotracheal tube [ETT] cuff leakage) in mechanically ventilated, critically ill patients.~   "
73967|NCT02598700|"~     In total hip arthroplasty, cup anteversion is an important factor in stability. Lewinnek's~     safe zone and functional anteversion are often used to assess appropriate orientation.~     However, these approaches do not consider the effect of the spinopelvic chain and lumbar~     mobility when in the seated position. This study will measure functional anteversion when~     standing and sitting with patient-specific computer models and define a quantitative~     relationship between the change in functional anteversion and spinopelvic parameters. This~     will challenge the historical paradigm of the safe zone and provide a tool to define~     anteversion based on a patient's mechanics and reduce risk of dislocation.~   "
73968|NCT02598687|"~     Open-label, single-center phase 1 study of an investigational agent TH-302 and standard~     chemoradiotherapy with a 3+3 dose escalation design through 3 dose levels.~   "
73969|NCT02598674|"~     Sepsis is the most common cause of childhood death worldwide. Millions of children survive,~     but are left with impaired health. Sepsis-related Acute Kidney Injury (sAKI) is increasingly~     recognized as a significant factor associated with long-term mortality among different~     patient populations. Renal dysfunction and subsequent chronic kidney disease is implicated in~     the development of hypertension and cardiovascular disease. The investigators overall~     hypothesis is that, in the pediatric population, sepsis-related AKI will have unrecognized,~     long-term consequences with regard to kidney function, endothelial function, blood pressure~     control, and overall health.~   "
73970|NCT02598661|"~     The purpose of this study is to evaluate the efficacy and safety of imetelstat in transfusion~     dependent participants with low or intermediate-1 risk myelodysplastic syndrome (MDS) that is~     relapsed/refractory to erythropoiesis-stimulating agent (ESA) treatment.~   "
73971|NCT02598648|"~     In the clinical data, the changes of RIPK3 and FXR were monitored in the lung lavage fluid~     and blood from the patients.~      In vivo experiments to find high risk factors to induce AEC necrosis and further lead to ARDS~     evidence, can provide a more direct theoretical research foundation for the pathogenesis of~     ARDS.~   "
73972|NCT02598635|"~     Aim: To investigate whether cholecalciferol (4800 U/daily) or placebo for 16 weeks reduces~     proteins levels associated with vascular calcification (osteoprotegerin, osteopontin,~     osteocalcin) in patients treated with peritoneal dialysis and 25(OH) vitamin D deficiency.~   "
73973|NCT02598622|"~     The purpose of this study is to see if a drug called Acetyl-L-Carnitine can help prevent~     painful nerve damage and nerve pain which is caused by vincristine, a drug used in~     chemotherapy in children being treated for newly diagnosed ALL. Acetyl-L-Carnitine is a drug~     available for purchase as a nutritional supplement but for the purpose of this study is~     experimental.~   "
73974|NCT02598609|"~     Adverse events are frequent in Neonatal Intensive Care Units' (NICU) patients and account for~     a high morbidity and mortality. Possible severe adverse events are central line associated~     bloodstream infections (CLABSI), ventilator and catheter associated adverse events and~     medication errors. Severity of the patient's outcome after an adverse event can be classified~     using the National Coordinating Council for Medication Error Reporting and Preventing (NCC~     MERP) Index for categorizing medication errors.~      The study will test the hypothesis that rates of adverse events in NICU patients will be~     reduced by the implementation of an educational program for the NICU caregivers (nurses and~     physicians), consisting of strategies for recognizing and preventing adverse events in their~     unit. These strategies will be oriented to prevent CLABSI, medication errors, skin and nasal~     complications and ventilator and catheter-associated adverse events.~      This trial has a stepped wedge cluster design, in which the NICUs from 12 hospitals in France~     will be randomized to the timing of implementation of the educational program.~      In order to describe the adverse events occurring during the study period, an anonymous~     voluntary adverse event reporting system will be provided to the caregivers of the~     participating units. A nested study will examine how caregivers communicate with the~     patients' parents in case of adverse event (disclosure or not, and caregivers' reasons).~      The rates of adverse events will be measured retrospectively using a neonatal NICU trigger~     tool.~   "
73975|NCT02598596|"~     The purpose of this study is to evaluate the effect of a high zone tolerizing regimen of~     pegloticase on clinical outcome, as defined by an serum uric acid level <6 mg/dL, in patients~     with chronic, refractory gout.~   "
73976|NCT02598583|"~     This study is evaluating the safety, tolerability, efficacy, pharmacokinetics,~     pharmacodynamics, and immunogenicity of multiple IV doses of ALXN1210 administered to~     patients with PNH who have not previously been treated with complement inhibitor.~   "
73977|NCT02598570|"~     This study seeks to evaluate the safety and pharmacokinetics of duvelisib in Japanese~     participants with relapsed or refractory lymphoma.~   "
74009|NCT02598154|"~     The main objective of this study is to evaluate the metrological characteristics of the data~     processing algorithms from inertial sensors (FOX © HiKoB) for the reconstruction of movement~     relative to the reference system (VICON) for measurement of dorsiflexion at the beginning of~     a step and in the middle of the oscillating phase.~   "
73978|NCT02598557|"~     This randomized phase IIb trial studies how well alternative dosing of exemestane before~     surgery works in treating in postmenopausal patients with stage 0-II estrogen positive breast~     cancer. Chemoprevention is the use of drugs to keep breast cancer from forming or coming~     back. The use of exemestane may treat early stage (stage 0-II) breast cancer. Comparing the~     exemestane standard dose regimen versus two alternative, less frequent dose regimens may~     decrease undesirable symptoms and have similar efficacy in reducing serum estradiol.~   "
73979|NCT02598544|"~     Adipose tissue (AT) dysfunction is a commonly observed feature of metabolic dysfunction in~     obesity and diabetes. An important characteristic when examining AT function is the capacity~     to break down stored lipids (i.e. lipolysis) and its regulation. In the present study, the~     aim was to investigate whether atrial natriuretic peptide-mediated lipolysis is altered in~     different adipose tissue depots (subcutaneous and visceral adipose tissue) of obese subjects~     with or without type 2 diabetes, compared to age-matched lean men. Eventually, the knowledge~     gained from this research will contribute to a better understanding of the present adipose~     tissue dysfunction and to the optimization of exercise programs for people with obesity and~     diabetes.~   "
73980|NCT02598531|"~     The purpose of the SWIFT Trial is to answer two research questions.~        1. Does bariatric surgery before total knee arthroplasty (TKA) improve both perioperative~          and long-term outcomes of TKA in extreme obesity?~        2. Does bariatric surgery before TKA delay or possibly negate the need for arthroplasty?~   "
73981|NCT02598518|"~     The purpose of this study is to assess the effectiveness and implementability of ICT for~     co-occurring alcohol use and mental health disorders within community addiction treatment, as~     delivered by routine community addiction clinicians.~   "
73982|NCT02598505|"~     The purposes of this study are:~        1. To confirm safety of Indacaterol in stable Heart Failure.~        2. To determine whether beta 2 alveolar receptor stimulation by Indacaterol is able to~          ameliorate lung diffusion in heart Failure patients treated with beta blockers.~        3. To compare the effects of Indacaterol in patients treated with a non-selective beta~          blocker (Carvedilol) and a beta 1-selective beta blocker (Bisoprolol).~   "
73983|NCT02598492|"~     The aims of this study are (1) to find out the relationship between PaO2 and SaO2 among~     mechanically ventilated patients and (2) to create a reliable system to utilize SF ratios to~     impute the PF ratios in assessing the respiratory parameter of the SOFA score.~   "
73984|NCT02598479|"~     The IPTLD QoL Broad Study.~   "
73985|NCT02598466|"~     Research question: what are the patterns of patient-reported changes in physical function~     among adult patients using SC abatacept with moderate to severe RA since commencement of the~     compassionate use program (CUP).~   "
73986|NCT02598453|"~     The purpose of this study is to evaluate treatment adherence to different regimens of~     ibandronate in postmenopausal women with osteoporosis or osteopenia who are intolerant to~     daily or weekly alendronate or risedronate therapy due to gastrointestinal (GI) side effects.~     The anticipated time on study treatment is 12 months, and the target sample size is 517~     individuals.~   "
73987|NCT02598440|"~     This study will evaluate participant-reported preference for either ibandronate or a~     comparator drug in women with postmenopausal osteoporosis. The anticipated time of study~     treatment is 6 months, and the target sample size is 338 individuals.~   "
73988|NCT02598427|"~     The purpose of this research study is to determine how well pertuzumab and trastuzumab works~     in treating breast cancer that has spread to the brain. Pertuzumab and trastuzumab are~     treatments that stop breast cancer cells from growing abnormally by inhibiting (or blocking)~     members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2).~      Pertuzumab and trastuzumab have been found to be very effective for HER2-positive breast~     cancer and are FDA approved for treatment of metastatic breast cancer outside of the brain~     when given through the vein. This suggests that pertuzumab and trastuzumab may help shrink or~     stabilize HER2-positive breast cancer that has spread to the brain in this research study.~      In this research study, the investigators are looking to see whether pertuzumab and~     trastuzumab will work to decrease the size of or stabilize breast cancer that has spread to~     the brain.~   "
73989|NCT02598414|"~     In colorectal surgery, anastomotic leak and its septic consequences still remain as the most~     concerning complications resulting in substantial morbidity and mortality. A common~     determining factor for assessing the viability of a bowel anastomosis is adequate arterial~     perfusion to ensure sufficient local tissue oxygenation. Intraoperative near-infrared~     fluorescence (INIF) imaging using indocyanine green (ICG) dye is a novel technique which~     allows the surgeon to choose the point of transection at an optimally perfused area before~     creating a bowel anastomosis. Recently, the INIF imaging system has been installed on the~     robotic systems and this helps identify intravascular NIF signals in real time.~      Although reports from several case series and retrospective cohorts have described the~     feasibility and safety of this imaging system during robotic colorectal surgery, to date, no~     studies have addressed more systematically the outcomes of this technique in robotic surgery.~     Considering the limitations of these reports, investigators aim to conduct a prospective~     randomized trial to compare robotic procedures with or without INIF imaging in patients~     undergoing colorectal surgery.~   "
73990|NCT02598401|"~     The aim of this research is to examine the natural history of osteonecrosis in older~     children, teenagers and young adults with acute lymphoblastic leukaemia and lymphoblastic~     lymphoma within the UK. In addition to using and validating new, internationally agreed,~     standard definitions for osteonecrosis, this study will provide the data needed to develop a~     radiological classification which correlates with clinical status.~   "
73991|NCT02598388|"~     The purpose of this study is to assess the safety, tolerability and immunogenicity of~     different vaccination schedules of Ad26.ZEBOV and MVA-BN-Filo administered intramuscularly~     (IM) as heterologous prime-boost regimens in healthy and in HIV-infected adults.~   "
74010|NCT02598141|"~     The main objective of this study was to compare the diagnostic capability (sensitivity and~     specificity) of standard bacteriological analysis made from one or other of the two sampling~     processing techniques and perioperative management of samples : the Ultra Turrax method that~     uses grinding versus the standard method.~   "
75229|NCT02582242|"~     This trial is conducted in Asia. The aim of the trial is to compare efficacy and safety of~     thrice daily versus twice daily NovoMix® 30 (Biphasic insulin aspart 30) in subjects with~     type 2 diabetes inadequately controlled with basal insulin.~   "
73992|NCT02598375|"~     Stage 1 - Evaluation of Status of Early Reached Target Enteral Nutrition in critically ill~     children in the PICU (ERTEN in PICU).~      In critically ill children, there is no data on the factors influenced the enteral nutrition~     and feeding intolerance.The investigators aim to reach these goals in our study~        -  To initiate the enteral feeding in pediatric intensive care units or not~        -  To demonstrate the reasons whether early enteral feeding is initiated or not~        -  To determine the incidence of feeding intolerance~        -  To identify the situations such as analgesia ,sedation, catecholamines or individual~          preferences of the medical staff which lead to delay or interruption in enteral feeding~          in pediatric intensive care units~        -  To investigate the relation between the successful enteral feeding and mortality ,~          morbidity du to the sepsis , septic shock and multiorgan failure~      Stage 2 - IFABP as biomarker of feeding intolerance in critically ill children in the PICU~     (IFABP in PICU)~      Critically ill children are at increased risk for intestinal injury, gastrointestinal~     dysfunction and feeding intolerance, which are associated with delayed recovery and increased~     morbidity and mortality during their course in the pediatric intensive care unit. In~     critically ill children, there is little data on the factors influenced the enteral~     nutrition. We hypothesise that IFABP might be used as a biomarker which shows that the early~     intestinal damage due to these medications.~      Aim There is no information which shows that the role of the intestinal microcirculation~     problems and mucosal integrity on feeding intolerance in pediatric intensive care unit.We aim~     to reach these goals in our study~        -  To show the value of IFABP regarding the identifying feeding intolerance and early~          detection of enteral feeding intolerance~        -  To show the relation between the IFABP concentration and enteral feeding intolerance~        -  To show the relation between the mechanical ventilation settings , sedation , inotropic~          medications doses and IFABP concentration and feeding intolerance~        -  To show the relation between IFABP concentrations and mortality and morbidity due to the~          sepsis , septic shock and multi system organ failure~      Stage 1 (ERTEN in PICU) was completed . In many patients, initiation of feeding seems to be~     delayed without an evidence-based reason. ERTEN was achieved in 43 (25.3%) of 95 patients~     within 48 h after PICU admission. Patients with Early Initiation of Feeding were~     statistically significant more likely to have ERTEN. ERTEN was independent significant~     prognostic factors for survival (p<0.001), with reached target enteral caloric intake on day~     2 indicating improved survival.~   "
73993|NCT02598362|"~     Measuring serum and urine concentrations of ciprofloxacin after IV and oral administration in~     children aged 3 months - 17 years who are treated for urinary tract infections.~   "
73994|NCT02598349|"~     The prognosis for patients with localized pancreatic adenocarcinoma who are not surgical~     candidates is poor. Patients characterized as having borderline resectable disease treated~     with preoperative chemo-radiotherapy fair somewhat better - although many of these patients~     are not converted to resectability. It may be argued that intensification of local and~     regional therapy might 1.) Increase the share of patients able to undergo curative surgery~     and 2.) Improve the local disease control interval and extend survival for patients who~     remain unresectable. Therefore, the purpose of this research study is to determine if an~     increase in the number of surgical resection pancreatic adenocarcinoma is higher than~     historical data by using a combined treatment of proton radiation with capecitabine (oral~     chemotherapy).~   "
73995|NCT02598336|"~     Measurements of Structured Light Plethysmography (SLP) using a chest wall movement based~     method will be compared to those obtained by spirometry using a flow based pneumotachograph~     method. This study will enable validation of SLP in children and adults by allowing direct~     comparison of simultaneous measurements of breathing sequences using the two measurement~     techniques.~      The investigators will also examine, in a group of normal adults, repeatability of the~     agreement between the two devices, and whether the agreement is affected by a change in tidal~     breathing parameters.~   "
73996|NCT02598323|"~     State of the question and research objective: International trials have shown that ultrasound~     measurement of the cervix identifies a population at high risk of preterm delivery. In case~     of short neck several types of treatments can be recommended: progesterone, the establishment~     of a strapping or pessary. These three treatments reduce the risk of preterm delivery. There~     is no French study.~      The objective of this study is to reduce prematurity in the PACA region Monaco-Corsica by~     introducing a routine ultrasound screening strategy asymptomatic short necks.~      Population concerned: All patients with active singleton pregnancy between 16 and 26 SA SA~     are eligible to ultrasound of the cervix.~        -  Primary endpoint: delivery rate before 37 weeks.~        -  Criteria secondary judgments rate of deliveries before 37 weeks, neonatal mortality~          morbidity.~      Expected result: a prematurity of 50%~   "
73997|NCT02598310|"~     The purpose of this study is to evaluate the efficacy and safety of nab-PTX and trastuzumab~     for ER negative and HER2 positive operable (tumor size of 3cm or less and N0) breast cancer.~   "
73998|NCT02598297|"~     Myelofibrosis patients with high molecular risk mutations have an intrinsically aggressive~     disease with increased risk of leukemic transformation and reduced overall survival. As there~     are no therapies currently established in the subset of high molecular risk patients with~     early myelofibrosis, the study aims to evaluate ruxolitinib in this patient population.~   "
73999|NCT02598284|"~     This study evaluates the ability of small primary care practices to 1) implement~     point-of-care and population management quality improvement strategies to improve~     cardiovascular quality of care (e.g., clinical decision support, patient education and~     counseling, or referral to smoking quit lines), and 2) implement the PopHealth performance~     measurement software to evaluate performance on the ABCS (aspirin when appropriate, blood~     pressure control, cholesterol management, and when applicable, smoking cessation) and allow~     regional benchmarking. This minimal risk study is a practice-randomized trial to determine a)~     whether point of care strategies improve ABCS performance measures compared to baseline, and~     b) whether adding locally tailored population management strategies to POC strategies~     improves performance on the ABCS measures more than POC strategies alone.~   "
74000|NCT02598271|"~     Acute kidney injury (AKI) is an infrequent but major and well - recognized complication of~     cardiac surgery. Recent studies demonstrated that even minimal increases in serum creatinine~     are associated with a rising risk of mortality, hospital length of stay, and cost.~     Furthermore a cut-off for baseline serum creatinine and its influence on mortality after~     cardiac surgery has been shown.~      In this study the investigators want to test if increased bSCr is influenced by body~     composition. Further the investigators want to determine if the incidence of AKI is different~     in patients below or above the estimated cut-off. Therefore the investigators want to perform~     a prospective cohort analysis and will take several other body composition and nutrition~     parameters to test their influence on the predictive power of bSCr. Furthermore the~     investigators want to evaluate several novel biomarkers for AKI on their predictive effect in~     cardiac surgical patients.~   "
74001|NCT02598258|"~     The purpose of this study is to determine the safety on sauna followed by cold water bath, a~     common practice in many countries, 30 healthy subjects aged 40 years and older will be at the~     Montreal Heart Institute Prevention and Cardiac Rehabilitation centre.~   "
74002|NCT02598245|"~     Transobturator tapes (TOT) are placed according to the surgical technique described by~     Delorme et al. in patients with a previous cervico-sacropexy (CESA) or vagino-sacropexy~     (VASA). Before final Fixation of the tapes and suturing the vaginal skin a Hegar dilator~     sound with either 8 mm or 6 mm diameter is placed in the urethra and a second Hegar dilator~     sound with either 4 mm or 3 mm diameter is placed between the tape and the urethra. After~     suturing the vaginal skin the Hegar sounds are removed.~   "
74011|NCT02598128|"~     Protocol ALCT-0000497 is a multicenter safety, tolerability and fat absorption study that~     anticipates enrolling 35 male and female subjects (pediatric and adult) with cystic fibrosis.~     Subjects with confirmed exocrine pancreatic insufficiency will use a novel enteral feeding~     in-line digestive enzyme cartridge (RELiZORB) connected to enteral pump sets.~   "
74012|NCT02598115|"~     The primary objective of this study is to evaluate the impact of the implementation of~     collaborative pharmaceutical care on drug support at admission for patients 65 years of age~     and older.~      This is a cluster-randomized study with a stepped-wedge design. Clusters correspond to~     participating centers. A randomly selected center is crossed-over into the intervention every~     fifteen days after the start of inclusions.~   "
74013|NCT02598102|"~     Double J (DJ) stents are placed following upper urinary tract surgeries. DJ stents are~     usually removed under local anesthesia using rigid cystoscope. Patients experience a lot of~     pain during this procedure and also continue to have discomfort during voiding for few days.~     The use of lignocaine jelly during this procedure is not very effective. Use of diclofenac~     suppository during flexible cystoscopy has been proven to be effective. This study was done~     to assess the effect of oral diclofenac in pain relief in patients undergoing DJ stent~     removal by rigid cystoscopy when compared to placebo and to assess its safety in these~     patients~   "
74014|NCT02598089|"~     This is a phase I, double-blind, randomized, placebo-controlled trial with two groups of~     subjects to receive seasonal trivalent inactivated split virion influenza vaccine (A/H1N1;~     A/H3N2 and B strains) or placebo (phosphate buffered saline). A total of 60 healthy male and~     female adults 18 through 45 years of age will be randomized to receive vaccine (30) or~     placebo (30).~   "
74015|NCT02598076|"~     All subjects will attend an initial clinic visit with the neuropsychiatrist and~     epileptologist. At the end of this visit, those subjects randomized to motivational~     interviewing will be questioned using standardized motivational interviewing techniques by~     the study author who is a board certified neurologist and who will have formal training and~     certification in motivational interviewing.~      Those subjects randomized to the control group will also undergo an initial clinic visit with~     a neuropsychiatrist and neurologists. However they will not undergo any subsequent~     motivational interview. Following the initial clinic visit, all subjects with ongoing~     seizures will either be scheduled for ongoing psychotherapy for treatment of PNES at Brigham~     and Women's Hospital or referred to a local psychotherapist according to their preference.~      All subjects will be contacted by phone at 3 month follow-up. If necessary they will be~     called 5 times at various times during the day and early evening. If they are not reached,~     they will receive a letter requesting them to contact the study staff to complete the study.~     Subjects will be questioned about their adherence to treatment. The primary outcome will be~     the number of psychotherapy sessions for the treatment of PNES in which they have~     participated over the past three months. They will also be assessed for secondary outcomes~     including dichotomous adherence (either seizure freedom or active participation in~     psychotherapy for the treatment of PNES, with more than 5 sessions over the past 3 months),~     seizure frequency over the past month, number of hospitalizations and emergency department~     visits over the past 3 months, and quality of life as measured by the brief QOLIE-10~     instrument. For those patients who give permission, their psychotherapists will be contacted~     by study staff to confirm the exact number of psychotherapy sessions over the past 3 months.~     A standard Partners clinical records release form with the patient's signature will be sent~     to the therapist's office.~   "
74016|NCT02598063|"~     This study will evaluate the efficacy and safety of peginterferon alfa-2a or ADV, in~     participants with lamivudine-resistant HBeAg-positive chronic hepatitis B. Participants will~     be randomized to receive either peginterferon alfa-2a for 48 weeks in combination with oral~     lamivudine for the first 12 weeks, or ADV for 72 weeks in combination with oral lamivudine~     for the first 12 weeks. The anticipated time on study treatment is 72 weeks, and the target~     sample size is 255 individuals.~   "
74017|NCT02598050|"~     The purpose of this work is to determine whether preoperative cognitive screening of patients~     over the age of 65 can be used as predictor of postoperative outcomes in patients undergoing~     lower extremity surgical procedures. This work is important as it may aid patients, families~     and physicians about the appropriateness of the surgical procedure and in providing resources~     to patients who are at the highest risk of adverse outcomes.~   "
74018|NCT02598037|"~     Obesity is considered one of the most troubling chronic diseases for public health because of~     its rapid growth in the population. Many are the causal factors of this epidemic, and in~     recent years studies suggest the involvement of genetic factors in the etiology of obesity as~     a risk factor for its development. Polymorphism of the FTO gene is being studied in the past~     eight years and has been indicated as a predictor of obesity in the population, as well as~     associations in food intake, raising the possibility of influence in the regulation of hunger~     and satiety. Accordingly, researchers observed changes in levels of postprandial leptin and~     ghrelin, which can promote appetite and change the quantity and quality of food intake in~     subjects with the polymorphism FTO.~   "
74019|NCT02598024|"~     The purpose of this study is to determine whether two types of short-term trauma-focused~     therapies (individual Narrative Exposure Therapy and group-based Control-Focused Behavioural~     Treatment) are effective in the treatment of chronic PTSD in earthquake survivors of Nepal.~   "
74020|NCT02598011|"~     This is a multi-center, open label trial of combination therapy with Toca 511 and ascending~     doses of Toca FC added to the SOC for newly diagnosed HGG.~   "
74021|NCT02597998|"~     The aim of this study is to assess the mass balance recovery from excreta of carbon 14~     labelled BI409306 ([14C] BI 409306) in healthy, CYP2C19 genotyped subjects and to provide~     plasma, urine and faecal samples for metabolite profiling and structural identification.~   "
74022|NCT02597985|"~     Transcatheter aortic valve replacement (TAVR) is a treatment alternative among high-risk~     elderly with aortic stenosis, however, mortality remains high. Fifty percent of patients~     undergoing TAVR exhibit frailty, a syndrome associated with poor survival. It is unknown~     whether interventions to improve frailty before TAVR (prehabilitation) will improve outcomes~     after TAVR. This study plans to evaluate whether simple cardiac exercise interventions to~     improve physical performance before TAVR improves outcomes after TAVR.~   "
74023|NCT02597972|"~     Will patients who suffer complex humerus fractures have better functional outcomes and less~     implant failure with shoulder replacement (reverse total shoulder arthroplasty, RTSA)~     compared to shoulder repair (open reduction and internal fixation, ORIF)?~   "
74024|NCT02597959|"~     1. What are the risk factors that contribute to musculoskeletal injuries and fatigue on~          allied health professionals in surgical care (e.g. scrub nurses, surgical assistants,~          and circulating nurses)?~        2. Can the investigators design wearable devices that the investigators can later evaluate?~   "
74025|NCT02597946|"~     to investigate effectiveness and safety of afatinib in the advanced NSCLC patients with HER2~     mutations, previously treated with 1 or 2 chemotherapy regimens~   "
74026|NCT02597933|"~     Systemic Sclerosis (SSc) is a devastating disease of unknown etiology. Patients suffer from~     multiple organ fibrosis whereas lung fibrosis (interstitial lung disease, ILD) is one of the~     main driver for mortality. There is preclinical evidence for efficacy of nintedanib in SSc~     and associated ILD (SSc-ILD) and the anti-fibrotic efficacy of nintedanib was proven in~     idiopathic pulmonary fibrosis patients, who are presenting a similar pattern regarding lung~     fibrosis. Hence it is the purpose of the trial to confirm the efficacy and safety of~     nintedanib 150 mg bid in treating patients with SSc-ILD, compared with placebo. The trial~     will be conducted as a double blind, randomised, placebo-controlled trial with primary~     efficacy evaluation at week 52 and placebo-controlled treatment until last patient out (up to~     a maximum of 100 weeks). Respiratory function is globally accepted for assessment of~     treatment effects in patients with lung fibrosis. The chosen endpoint (Forced Vital Capacity~     (FVC) decline) is easy to obtain and is part of the usual examinations done in patients with~     SSc-ILD.~   "
74027|NCT02597920|"~     The aim of this non-interventional study is to describe patient's perception of anticoagulant~     treatment when using Pradaxa® to prevent stroke and systemic embolism while suffering from~     atrial fibrillation (according to its approved indication in the approved dosages of 110 mg~     or 150 mg twice daily) in comparison to standard care using Vitamin K Antagonist (VKA).~   "
74028|NCT02597907|"~     The purpose of this study was to compare the antiemetic efficacy of aprepitant plus~     palonosetron versus aprepitant plus ramosetron in high risk patients undergoing laparoscopic~     cholecystectomy.~   "
74029|NCT02597894|"~     This pilot clinical trial studies targeted biopsies in determining response in patients with~     prostate cancer undergoing high-dose-rate brachytherapy (a type of radiation therapy in which~     radioactive material sealed in needles, seeds, wires, or catheters is placed directly into or~     near a tumor). Studying tumor tissue obtained before and after treatment may help doctors~     understand changes in a pathway that looks at how deoxyribonucleic acid (DNA) is repaired~     after it is damaged and to see if there are differences in the prostate tissue prior to and~     after starting androgen deprivation therapy.~   "
74030|NCT02597881|"~     The purpose of this study is to create an electronic registry to house phenotypic information~     from patients with achondroplasia. The initial focus of this registry will be to include U.S.~     patients with achondroplasia. Once populated, the collective data can be queried to pursue~     clinical research questions pertaining to health outcomes and treatment options for patients~     with this conditions. The registry is longitudinal in nature with the functionality to~     retrospectively enter patients' clinical data from the prenatal period up through the most~     recent encounter, with all intervening data entered in a chronologic fashion.~   "
74031|NCT02597868|"~     A multi-sites study about the efficacy of sequential monotherapy: Capecitabine vs. endocrine~     therapy, in metastatic breast cancer patients with HR-positive & HER2-negative after~     capecitabine-base chemotherapy.~   "
74032|NCT02597855|"~     To compare the short-term effect of intravitreal aflibercept injection between two subtypes~     of polypoidal choroidal vasculopathy~   "
74033|NCT02597842|"~     This is a single center, randomized, double-blinded, controlled clinical trial.The purpose of~     this study is to compare the effect of TEAS pretreatment with single acupoint or two~     acupoints for postoperative nausea and vomiting in patients undergoing laparoscopic~     operation.~   "
74034|NCT02597829|"~     A prospective open label trial of adult patients with active Crohn's disease to determine if~     plasma concentrations of certolizumab pegol correlate to mucosal healing.~   "
74035|NCT02597816|"~     Congenital uterine anomalies are found in 8% of infertile women and 24.5% of infertile women~     with a history of recurrent miscarriage, with septate and sub-septate uterus being the most~     common anomalies in these women, Also, septate uterus is the commonest anomaly found in~     infertile women requiring assisted reproductive technology.~      Published data showed improved Cumulative pregnancy rate and live birth rate, and a~     significant reduction in Miscarriage rate in In Vitro Fertilization women after hysteroscopic~     metroplasty of both small and large septate compared to non-operated women.~      Investigators hypothesized that trans-vaginal three Dimensional Ultrasound will be superior~     to Hystro-salpingography for the differentiation between arcuate and septate uterus in~     infertile women scheduled for In Vitro Fertilization.~   "
74036|NCT02597803|"~     The objective of this study is to compare the safety and efficacy of RGN-259 Ophthalmic~     Solutions to placebo for the treatment of the signs and symptoms of dry eye.~   "
74037|NCT02597790|"~     The CTSI-PLACE Study is a study for men and women with HIV/hepatitis C co-infection or HIV~     only. The study looks at the impact of having hepatitis C virus in addition to HIV on risk~     for cardiovascular disease. Participants will undergo non-invasive assessment of~     cardiovascular disease risk through measurements of endothelial function and blood biomarkers~     at baseline and 1 year (or 4 weeks and 24 weeks after end of HCV treatment for those that~     undergo HCV treatment during study follow-up).~   "
74038|NCT02597777|"~     This is a randomized double-blinded study examining the effect of topical Acetyl~     Hexapeptide-8 AH8) for improving the cosmetic appearance and experience of oily skin.~   "
74039|NCT02597764|"~     Urination is a result of a complex neuro-muscular coordination which involves the action and~     arrangement of different parts of nervous systems as well as the muscular structure of the~     lower part of the urinary system. When there is an abnormal pattern in bladder and bowel~     habits without any known neuronal lesions, the condition is called bladder and bowel disorder~     (BBD). The symptoms can range from the feeling of rushing to the toilet, urinary accidents to~     urinating much less than expected during the day.~      The standard treatment for most cases of BBD starts with Standard Urotherapy (SU) which is a~     beneficial basic and harmless form of treatment widely used for all children with BBD. SU~     involves explaining of the problem to the children and their parents by the doctors and~     educating them on proper voiding mechanisms, sitting, and standing positions as well as how~     and when to void.~      The purpose of this study is to explore the possibility of testing the additive effectiveness~     of Diaphragmatic Breathing exercise (DB) as an alternative and harmless additional treatment~     to SU in children with BBD.~   "
74175|NCT02595970|"~     Evaluate psoriasis severity and its psychosocial impact using a novel Patient Reported~     Outcome (the Simplified Psoriasis Index SPI) at 16 weeks, as well as long-term safety,~     tolerability and efficacy of secukinumab administered subcutaneously during 52 weeks (plus~     extension) in patients with moderate to severe psoriasis.~   "
74040|NCT02597751|"~     Developmental coordination disorder (DCD) affects 5-6% of the school-age population, equating~     to ~400,000 children, or 1-2 students in every Canadian classroom. Children with DCD find it~     hard to learn motor skills and perform everyday activities, such as getting dressed, tying~     shoelaces, using utensils, printing, riding a bicycle, or playing sports. Researchers and~     clinicians do not know what causes DCD or why children with DCD struggle to learn motor~     skills. Using MRI, this study will increase understanding of how the brain differs in~     children with/without DCD and determine if rehabilitation can change the brain and improve~     outcomes of children with the disorder.~   "
74041|NCT02597738|"~     The purpose of this study is to further advancements in biospecimens (blood cellular free~     component, e.g., plasma, serum, tissue), in order to develop precision medicine, for lung~     cancer management and lung cancer screening (synergy with imaging). A co-clinical trial~     approach, with integrative analyses leveraging data from the treatment of genetic mouse~     models of lung cancer along with clinical samples and data from lung cancer patients, will be~     used to elucidate genomic background metrics, identify cell free DNA mutations, and further~     refine the liquid biopsy approach.~   "
74042|NCT02597725|"~     The purpose of this study is to describe the urinary morbidity as a result surgery and~     radiation therapy, in patients treated for prostate cancer.~      All the patients will undergo a Urodynamic examination to verify the grade of Urinary~     morbidity.~   "
74043|NCT02597712|"~     A phase 2, randomised, double-blind, out-patient trial to determine if YF476 is a safe and~     effective treatment in patients with Barrett's esophagus.~   "
74044|NCT02597699|"~     The feticide is a legal and ethical obligation during a termination of pregnancy after 22~     weeks' gestation. This method raise concerns about the fetal pain, maternal complications and~     the fetopathologic analysis. There are few studies on the subject. Investigators want to~     evaluate a drug in order to facilitate this method technically and emotionally challenging.~     They want to achieve a quick fetal asystole, a fetal analgesia, a maternal security and a~     optimal fetopathologic analysis. A drug, remifentanil Ultiva®, seems could meet its~     properties, it is a powerful morphine. A phase 2 clinical trial has assessed the feasibility,~     efficacy and safety of Ultiva®. They had not been able to prove bradycardia or lethal effect~     of Ultiva injected alone but the feasibility and safety were good.~      Investigators want to set up a randomized clinical trial with 2 arms : Ultiva® and lidocaine~     versus sufentanil and lidocaine (standard protocol), it is a bicentric study. The primary~     outcome is the interval between the vascular injection of lidocaine and fetal asystole. The~     secondary outcomes are the success rate of method, the number of puncture of the umbilical~     cord, the maternal side effects and the quality of fetopathologic analysis.~      The previous observational study showed a median interval of 2,3 minutes and a success rate~     of 55% (lower interval to 2 minutes). From the results they calculate a necessary inclusions~     to 66 patients.~      They believe that the bradycardia property of Ultiva® allow a potentiation of the efficacy of~     lidocaine. If the results are satisfactory, the use of Ultiva® can be generalized to other~     fetal medicine team.~   "
74045|NCT02597686|"~     When the investigators are caught up in emotions, it is by stepping back (or decentering)~     that the investigators are able to see the situation from another perspective. Individuals~     with emotional disorders, however, can have difficulties in being able to do this.~      Research has shown that improving an individual's ability to step back from their emotions~     and take perspective is possible and can have beneficial effects on depressive symptomatology~     (Self Distancing and Perspective Broadening [SDPB] training). The SDPB training package~     involves two techniques: 1) stepping back from situations using mental imagery (building a~     mental picture of the situation and changing the distance to it) and, 2) reframing situations~     using perspective broadening reappraisals (giving new meanings to situations). The training~     package trains these SDPB techniques using an individual's memories and every day events. The~     fortnightly training comprises of two one to one sessions and daily homework for a week in~     between.The SDPB training package is aimed at improving an individual's ability to step back~     from, and put a new meaning to emotional events that take place in their lives.~      The prospective pilot study aims to investigate whether the SDPB training package reduces~     symptomatology and improves these abilities in individuals who experience both depressive and~     manic episodes (Bipolar Disorder [BD]).~      BD has a cumulative lifetime prevalence ranging from 1.52% across Europe and is treated with~     moderate success using Cognitive Behavioural therapy (CBT). However, 'moderate success' is~     considerably low compared to other mental health problems and CBT can be time time consuming,~     expensive, and cognitively demanding (requiring a high level of functioning of one or more~     cognitive functions). Accordingly, BD may be one of the emotional disorders in greatest need~     of novel and evidence based treatments.~   "
74046|NCT02597673|"~     The overall objective of this project is to compare the three home-managed treatment regimens~     for PFPS: neuromuscular electrical stimulation (NMES), transcutaneous electrical nerve~     stimulation (TENS), and NMES combined with TENS to a standard home exercise program (HEP).~     Each of the three treatment arms will be supplemented by HEP and compared to a group~     receiving standard HEP alone. The central hypothesis is that the combination of NMES with~     TENS will show significantly greater improvements in muscle strength, mobility, pain, daily~     activity and quality of life (QOL) than HEP alone.~      The investigators are examining: 1) whether the three treatment regimens are significantly~     more efficacious than standard HEP alone in improving lower extremity muscle strength,~     physical activity, mobility, pain, and quality of life; 2) lower extremity muscle strength,~     physical activity, mobility, pain, and quality of life differ significantly across the 4 time~     periods; 3) is there an interaction between treatment and time in relation to lower extremity~     muscle strength, physical activity, mobility, pain, and quality of life.~   "
74047|NCT02597660|"~     Patellar tendinopathy is one of the most frequent causes of non-traumatic knee pain and~     reduced function in patients. Standard treatment options for patellar tendinopathies include~     non-steroidal anti-inflammatory drugs, corticosteroids, cryotherapy, manual therapy,~     eccentric exercises, and ultrasound. Unfortunately many patients fail to respond to these~     therapies and return to normal activity levels, and recurrence rates for those who do respond~     are unacceptably high. Many patients who fail to respond display persistent degenerative~     changes on imaging studies suggesting a failure to regenerate the pathological tissue.~     Developing new therapies that can directly promote the synthesis of new, healthy~     extracellular matrix tissue could therefore address an important therapeutic need and make a~     substantial improvement in our ability to effectively treat patellar tendinopathy and reduce~     recurrence rates. Somatropin (human growth hormone of recombinant DNA origin) has been shown~     to increase protein synthesis and matrix production when delivered directly into the tendon.~     This study will evaluate the ability of somatropin to improve clinical outcomes and tissue~     quality in patients with chronic tendinopathy.~   "
75609|NCT02577276|"~     Is a unique tele-rehabilitation service directed at treating upper limb weakness due to~     stroke feasible to provide at Mayo Clinic and are the individuals with stroke and the~     clinicians providing the care satisfied with the process?~   "
74048|NCT02597647|"~     This study will serve to determine how influenza infection alters the bacterial colonization~     patterns in the nasal and oropharyngeal compartments, and whether the immune response~     correlate with these alterations. The investigators will be determining bacterial composition~     and immune responses in the nose and oropharynx during influenza infection.~      Specific Aims~      Therefore, the overall aims of this study are as follows:~        1. To identify baseline composition and kinetic changes in the nasal and oropharyngeal~          microflora and immune responses after administering intranasal live attenuated influenza~          virus (i.e., FluMist® vaccine) or saline mist to healthy subjects;~        2. To identify nasal and oropharyngeal microbial composition and local immune responses~          during influenza infections and after resolution of infection, and correlate these~          changes with clinical outcomes.~   "
74049|NCT02597634|"~     This is a Phase 3, prospective, randomized, dual-center, double-blind, placebo-controlled,~     parallel-group study designed to determine the efficacy and safety of SST-0225 (5.4 grams,~     applied up to 6 times in 24 hours, over a 48-hour dosing period) for the treatment of pain~     associated with DOMS.~   "
74050|NCT02597621|"~     Multi-center, observational, prospective cohort study including patients with~     multidrug-resistant tuberculosis at different sites in Germany.~      The aim the study is the identification of biomarkers for therapy response.~   "
74051|NCT02597608|"~     This is a randomized study in three areas of Bangladesh (Chars region where CLP operates,~     Haor region where Shiree operates, and urban slums where UPPR operates). Treatment is~     assigned at the community level, where treatments are:~        -  Livelihoods intervention only (L only)~        -  Livelihoods intervention plus nutrition intervention (L+N)~      In UPPR only, the study also includes a non-randomly selected comparison group (C).~      Within treatment localities, targeted beneficiaries include women, adolescent girls, and~     children under 24 months. Benefits are received for two years.~   "
74052|NCT02597595|"~     The aim of this study is to evaluate the cardioprotective effect of spirulina in children~     with beta thalassemia.~   "
74053|NCT02597582|"~     The aim of this prospective randomized study was to investigate if the LigaSure vessel~     sealing system can reduce the operation duration and the postoperative drainage amount in~     patients undergoing neck dissection.~   "
74054|NCT02597569|"~     Patients with cognitive impairments following a stroke are often denied access to inpatient~     rehabilitation, despite evidence of its benefits for them. Patients with cognitive impairment~     who are admitted to inpatient stroke rehabilitation often receive services based on outdated~     impairment-reduction models, rather than recommended function-based approaches. These two~     issues, reduced access to rehabilitation and the knowledge-to-practice gap, both stem from a~     reported lack of skills and knowledge on the part of some stroke rehabilitation teams to~     foster recovery in people with cognitive impairments. To address these issues, the~     investigators will implement and evaluate a multi-faceted, supported, integrated knowledge~     translation initiative, targeted specifically at the inter-professional application of the~     Cognitive Orientation to daily Occupational Performance (CO-OP), called CO-OP KT. CO-OP is a~     contemporary, effective, cognitive strategy-based treatment approach. CO-OP KT is a~     combination of the CO-OP Approach with multi-faceted knowledge translation support. Clinical~     staff at participating institutions will receive CO-OP KT training.~      The long-term objective of CO-OP KT is to optimize functional outcomes for individuals with~     stroke and cognitive impairments. Three specific research questions have been posed, one of~     which is the focus of this registration. That sub study relates to patient outcomes following~     the CO-OP KT training initiative and it will be addressed using a non-randomized design with~     historical controls. Patient participants who enroll in the project prior to implementing the~     CO-OP KT training will belong to the historical control group. Patient participants who~     enroll in the project after the CO-OP KT training will belong to the CO-OP KT Exposure group.~   "
74055|NCT02597556|"~     Cheap and effective drugs called 'anthelmintics' are routinely administered to children in~     developing countries to eliminate infections by parasitic helminths. However, the effects of~     anthelmintic treatment on other pathogens (e.g., bacteria, viruses, protozoa) remain unknown.~     The aim of this study is to investigate the impact of anthelmintic treatment on the incidence~     of viral- and bacterial-induced diarrhea in school children in southern Vietnam. Diarrheal~     disease remains a substantial cause of morbidity and mortality in children in Vietnam, and~     these children are typically co-infected with intestinal helminths. As helminths and~     diarrheal pathogens infect the same intestinal niche, anthelmintic treatments may alter host~     immune responses and the composition of the gut microbiota in ways that affect infection and~     disease risks caused by diarrheal pathogens.~      This study will recruit 350 helminth-infected and 350 helminth-uninfected children aged 6-15~     years. Recruited children will be randomized to receive either anthelmintic or placebo~     treatment once every three months and will be monitored for incidences of diarrheal disease~     for 12 months. At the 12-month time point, all children will receive anthelmintic treatment.~     Blood and stool samples will be collected throughout the study and used for evaluation of~     anemia and host immune responses, and for classification of gut microbes and parasite~     detection, respectively. The interventional study proposed here will provide an important~     first test of whether anthelmintic treatments have any indirect effects on infections caused~     by diarrheal pathogens.~   "
74056|NCT02597543|"~     The investigators will use cardiac MRI to measure the myocardial perfusion reserve and amount~     of myocardial edema and fibrosis in heart-transplant patients with nonspecific allograft~     dysfunction in contrast to those with normal graft function. The investigators hypothesize~     that patients with nonspecific allograft dysfunction will demonstrate decreased myocardial~     perfusion reserve, related to microvascular allograft vasculopathy, compared to those with~     normal graft function.~   "
74057|NCT02597530|"~     To determine whether treating by transcutaneous electrical acupoint stimulation (TEAS)~     combined with general anesthetic during peri-operative could alleviate the dosage of~     anesthetic drugs compared with control and sham group.~   "
74087|NCT02597127|"~     This study is a Phase II, placebo-controlled, double-blind, randomized trial in 480~     participants with atherosclerotic cardiovascular disease (ASCVD) or ASCVD-risk equivalents~     (for example, diabetes and familial hypercholesterolemia) and elevated LDL-C despite maximum~     tolerated dose of LDL-C lowering therapies to evaluate the efficacy, safety, and tolerability~     of ALN-PCSSC injection(s).~   "
74058|NCT02597517|"~     Endoscopy is a tool that has greatly influenced gastroenterological diagnosis. However,~     conventional endoscopy is limited to detecting lesions on the basis of gross morphological~     changes and therefore a certainly diagnosis depends on biopsy sampling of macroscopically~     obvious endoscopic features, or blind biopsy sampling of normal appearing mucosa with the~     risk of missed pathology and sampling errors.~      Gastric cancer is the second most common cause of cancer related death. One of the main roles~     of upper gastrointestinal endoscopy is to identify gastric cancer at an early stage. The~     importance of identifying H. pylori infection is because it plays a very important role in~     gastric carcinogenesis, progressing from chronic gastritis through atrophic gastritis,~     intestinal metaplasia, dysplasia and finally cancer. The importance of recognition a~     precancerous gastric lesion is because we can detect most tumors at an early stage and~     improve the survival.~      Most studies conclude that it is difficult to diagnose H. pylori related gastritis and~     gastric atrophy on the basis of endoscopic findings. Histology is therefore currently~     considered to be the gold standard for detecting H. pylori infection. The reliability of~     detecting H. pylori infection histologically depends on the site, number, and size of gastric~     biopsy specimens, as well as on expertise in staining and visualizing the bacteria.~     Considerable error also occurs in identifying gastric atrophy using blind biopsy sampling,~     and neither the original nor the revised version of the Sydney system reliably identifies~     more than half the cases in patients with confirmed gastric atrophy.~   "
74059|NCT02597504|"~     This research study will evaluate a standalone software application and is designed to~     standardize and validate new neurocognitive screening testing for children aged 6 through 11,~     and adolescents and adults ages 12 through 75.~      The purpose of this study is to evaluate recently developed computerized tasks sensitive to~     changes in neurocognitive performance after a concussion. These tests were designed to help~     measure the effects of concussion on cognitive processes (e.g., memory, attention, brain~     speed) and visual functioning.~   "
74060|NCT02597491|"~     In this sequential, multiple assignment, randomized trial (SMART) current smokers who are~     eligible for lung cancer screening will be identified using the electronic medical record at~     the University of Minnesota and Minneapolis VA (N=1000). All participants will receive 8~     weeks of evidence-based first-line smoking cessation treatment. Participants will be eligible~     for three potential randomizations during one year of smoking intervention: 1) to timing of~     identifying early response to treatment at 4 vs. 8 weeks (all participants), 2) to~     telephone-based tobacco longitudinal care (TLC) vs. TLC plus pharmacist-administered~     Medication Therapy Management (incomplete responders to first-line treatment, Primary Aim),~     and 3) to monthly TLC contact vs. quarterly TLC contact (complete responders to first-line~     treatment, Secondary Aim). The primary outcome will be 6 months of prolonged abstinence~     measured 18 months after the beginning of treatment.~   "
74061|NCT02597478|"~     The goal of this clinical research study is to learn if fentanyl can help shortness of breath~     in cancer patients. Researchers also want to learn if the study drug can help to improve your~     physical function.~   "
74062|NCT02597465|"~     An open label study to determine the efficacy and safety of SPARC1507~   "
74063|NCT02597452|"~     The primary purpose of this study is to measure the clinical utility (accuracy) of the~     hand-held breast scanner (iBE) for the detection of breast lesions or lumps. The iBE results~     will be compared to the results of a current mammogram and/or ultrasound. The duration of~     study participation is approximately 30 minutes one day.~   "
74064|NCT02597439|"~     The purpose of this study is to determine whether omega-3 fatty acids are effective in the~     prevention of psychosis in individuals at ultra-high risk for psychosis.~   "
74065|NCT02597426|"~     Nasopharyngeal carcinoma (NPC) is a type of head and neck cancer. The last three decades of~     research in head and neck radiation oncology have largely focused on improvements in~     survival, which have mostly come at the cost of long term toxicity for surviving patients.~      This is an observational study that is being done to learn about the long-term symptoms and~     side effects that survivors of nasopharyngeal cancer may have following radiation treatment.~     This study will include assessment of patient report outcomes, physician-graded adverse~     events, neurocognitive assessment and endocrine and hearing testing~   "
74066|NCT02597413|"~     The primary objective of this study is to evaluate the impact of systematic catheter-drainage~     of urine for parturient women immediately in the delivery room on the occurrence of~     post-voiding urine residue.~   "
74067|NCT02597400|"~     This is a Phase 1, open-label, sequential, multiple-dose, drug-drug interaction study of GK~     activator HMS5552 and metformin in patients with type 2 diabetes mellitus (T2DM).~   "
74068|NCT02597387|"~     To study efficacy and safety of Mitoxantrone HCL Liposome Injection in patients with diffuse~     large B-cell lymphoma and lymphoma peripheral T cell.~   "
74069|NCT02597374|"~     To study the reactivity of the mu rhythm during action and action-observation by EEG in~     children with unilateral cerebral injury.~   "
74070|NCT02597361|"~     This study aims to verify the hypothesis that patients with Vascular Ehlers Danlos syndrome~     (vEDS) should benefit of the blockade of angiotensin (Ang) II noxious effects on their~     vasculature affected by a defect in type III collagen in addition to the effects celiprolol.~     This randomized, double blind, placebo controlled trial compares the administration of the~     Ang II type I receptor blocker (ARB) — irbesartan— to placebo over a 2-year period in vEDS~     patients with the main objective to reduce the incidence of both symptomatic and asymptomatic~     vascular events.~   "
74071|NCT02597348|"~     This is a multicentric randomized parallel group open trial comparing 5-year survival of~     chemotherapy followed by LT (Group LT+C) versus chemotherapy alone (Group C) in patients with~     confirmed unresectable liver-only metastases, well controlled by chemotherapy (no~     progression) and extensively explored by modern imaging techniques. The primary objective of~     the trial is to validate in a large multicentric cohort of selected patients the possibility~     to obtain at least 50% 5-years survival with LT combined to chemotherapy compared to around~     10% with chemotherapy alone.~   "
74088|NCT02597114|"~     AGT-181 is a fusion protein containing alpha-L-Iduronidase that is intended to deliver the~     enzyme peripherally and to the brain, when administered intravenously. This study is an~     extension of a safety and dose ranging study to obtain long term safety and exposure data, as~     well as information on the biological activity of the investigational drug~   "
74072|NCT02597335|"~     This trial develops a non invasive diagnostic approach of IDH1 mutated gliomas combining~     mutation detection from free plasmatic DNA, D-2HG dosage in urine samples, and D-2HG~     detection by Brain Spectro MRI.~      In group 1 (25 patients), patients with presumed grade II-III gliomas candidate to surgery~     will undergo spectro MRI, plasma, urine dosages. Results will then be confronted to tumor~     mutational status and D-2HG.~      In group 2 (15 patients), patients with known IDH1 mutation will undergo spectro MRI, plasma,~     urine dosages overtime in order to correlate results with the response to treatment.~   "
74073|NCT02597322|"~     Axitinib (AXITINIB) is an oral, potent, and selective inhibitor of vascular endothelial~     growth factor receptors 1, 2, and 3 which has achieved objective response rate of 44.2% in~     phase II study in cytokine-refractory metastatic renal-cell cancer patients.~      Pre-surgical treatment with Axitinib could allow a substantial proportion of patients with~     large organ confined tumors to benefit from NSS.~      The Objective is to determine the efficacy of Axitinib administered prior to surgery in~     patients with large organ confined tumors not primarily suitable for NSS (cT2aNoNxM0) for~     shifting from a radical nephrectomy indication to a nephron sparing procedure.~   "
74074|NCT02597309|"~     The aim of this study is to evaluate the effect of adding a SGLT-2 inhibitor (namely~     Canagliflozin) on the dose of U-500 insulin required to achieve glycemic control in patients~     with type 2 diabetes. We hypothesize that adding Canagliflozin to patients treated with U-500~     insulin may result in significant reduction in insulin dose due to improved insulin~     sensitivity and weight loss.~   "
74075|NCT02597283|"~     This study is designed to test the hypothesis that the Biguard stent system will lead to~     fewer target lesion failure compared to regular stent system in patients with coronary~     bifurcation lesions at one year.~   "
74076|NCT02597270|"~     The purpose of this study is to describe the genetic diversity of Hepatitis C virus (HCV)~     NS3/4a protease and NS5A protein of HCV in participants with chronic disease naive-drug or~     previously failed to double therapy (Peg-interferon and Ribavirin) and to identify the~     frequency of natural polymorphisms in HCV NS3/4a protease and NS5A protein that are~     associated with direct-acting antivirals (DAAs)-resistance.~   "
74077|NCT02597257|"~     The investigators conducted a randomized, Double blind, and Controlled Study to evaluate the~     Efficacy and safety of Lidocaine Infusion Treatment in Management of Neuropathic pain.~   "
74078|NCT02597244|"~     Percutaneous Extraforaminotomy using BS extraforamonotomy kit(BioSpine Co.,Ltd, Seoul, South~     Korea), was performed in patients who did not show improvement lasting more than 1 month~     after diagnostic conventional fluoroscopically guided transforaminal epidural block with~     local anesthetic and steroid.~      Numeric rating scale(NRS) pain score, Oswestry disability index (ODI), Roland-Morris~     Disability Questionnaire (RDQ), claudication distance(CD) was checked before and after the~     procedure.~   "
74079|NCT02597231|"~     Recent data suggests that melatonin, a supplement available over the counter, may help~     prevent delirium in hospitalized patients. The investigators are hypothesizing that melatonin~     may help in delirium prevention by improving sleep quality and possibly circadian rhythm~     cycling in patients who are given the supplement. This pilot study involves a randomized~     placebo-controlled design in which participants will be randomized to receive either~     melatonin 3mg orally or placebo orally. Participants in both groups will be fitted with~     wireless actigraphy devices to obtain objective sleep quality, and will also receive a sleep~     questionnaire each morning to obtain subjective data on their sleep quality overnight.~     Delirium will be assessed by floor nurses twice daily using the Confusion Assessment Method~     (CAM).~   "
74080|NCT02597218|"~     Observational. Retrospective cohort.~   "
74081|NCT02597205|"~     The overarching goal of this program to increase the use of evidence-based,~     secondary-prevention medications and promote healthy lifestyles among myocardial infarction~     (MI) patients through using provider-facing mobile app and patients-facing text messages.~   "
74082|NCT02597192|"~     Aim: Evaluating the clinical effects of a Bacillus subtilis, Bacillus megaterium and Bacillus~     pumulus containing toothpaste, mouthwash and toothbrush cleaner versus a placebo in patients~     with generalized gingivitis.~      Materials and methods: In this double-blind placebo-controlled randomized clinical trial~     generalized gingivitis patients who were systemically healthy and who did not smoke were~     included. They used a placebo or probiotic Bacillus containing toothbrush cleaner for 8~     weeks. Primary outcome measures of interest were plaque and gingivitis index, secondary~     outcome measures were pocket probing depth and bleeding on probing.~   "
74083|NCT02597179|"~     The purpose of this study is to investigate and analyse genomic profiles in patient with~     breast cancer who failed standard treatment, refractory and young breast cancer.~   "
74084|NCT02597166|"~     There are now several licensed drug treatments for patients with HCV infection. These~     medications have been shown to be very effective in getting rid of the virus in patients with~     HCV infection including those with early stages of cirrhosis without complications known as~     compensated cirrhosis, with a greater than 90% cure rate. At present, there are very little~     data to show that treating patients with HCV infection and decompensated cirrhosis will give~     the same effects. However, patients with decompensated cirrhosis as a result of hepatitis B~     infection who received treatment to control their virus show improvement of their overall~     liver condition, and the liver complications of many of these patients disappeared. Also,~     patients with cirrhosis due to excess alcohol and who stopped drinking also showed~     improvement in liver function and their complications of cirrhosis coming under control.~     Therefore, treatment of patients with HCV infection and decompensated cirrhosis is expected~     to show the same positive effects, because the underlying cause of cirrhosis is coming under~     control. Harvoni is a combination of two direct-acting antivirals (ledipasvir and sofosbuvir)~     that prevents the hepatitis C virus from copying and multiplying themselves, allowing the~     body to clear the virus from their systems and be cured of HCV infection. This study is being~     conducted to find out if treatment with Harvoni will lead to clearance of HCV infection in~     patients with decompensated cirrhosis giving rise to improvement in liver function, together~     with improvement of quality of life and survival.~   "
74085|NCT02597153|"~     To study efficacy and safety of Mitoxantrone HCL Liposome Injection in patients with relapsed~     cutaneous T cell lymphomasell~   "
74086|NCT02597140|"~     The purpose of this randomized pilot study is to evaluate the effect of intravenous lidocaine~     on propofol requirement during BIS (Bispectral index) guided MAC (monitored anesthesia care)~     in facial plastic surgery.~   "
74089|NCT02597101|"~     The role of individual leukocyte populations in type 2 diabetes (T2D) and immunometabolism in~     general represent important gaps in knowledge to better understand the etiopathogenesis of~     T2D. Emerging evidence indicates that certain leukocyte populations serve as an important~     nexus of T2D-associated inflammation. This novel and innovative clinical trial will test the~     efficacy of a leukocyte-selective anti-inflammatory small drug as adjunctive therapy in~     improving insulin sensitivity in obese, insulin-resistant type 2 diabetic subjects. This~     trial also offers a first-in-kind opportunity to better understand the role of specific~     leukocyte populations in type 2 diabetes. The drug's clinical profile suggests that it will~     be well-tolerated with few, if any, side effects, and the existence of simple methods that~     can indirectly measure its activity in vivo~   "
74090|NCT02597088|"~     Human milk (HM) is more than a food complex; in addition to micronutrients and human-coded~     bioactive complexes it also includes many antioxidants, antibacterial, prebiotics,~     probiotics, immune-boosting constituents, and many other bioactive components. Some of these~     components may deteriorate during storage, and expressed EHM starts deteriorating as soon as~     it leaves the breast. Nevertheless, whenever nursing at the breast or feeding of fresh EHM is~     not possible, feeding of stored EHM is considered the next best thing to feeding at the~     breast. Efficient heat transfer abilities affect both heating and cooling processes.~      In this study the investigators wish to test a new device that permits rapid heating and~     cooling processes. The investigators plan to measure some thermolabile constituents of HM in~     order to determine whether they might be protected by a more gentle warming process. The~     investigators plan to collect milk from mother, to mix it and to test the effect of storage~     and heating.~      This experiment is design to test the feasibility and the efficiency of the device.~   "
74091|NCT02597075|"~     The purpose of this study is to assess whether a structured physical activity program (PA)~     during palliative chemotherapy improves progression-free survival (PFS) and/or~     patient-reported outcomes (ESAS-r) in patients with metastatic colorectal cancer.~   "
74092|NCT02597062|"~     The purpose of this study is to find out what effects carfilzomib has on relapsed multiple~     myeloma when administered in combination with cyclophosphamide and dexamethasone.~   "
74093|NCT02597049|"~     The main purpose of this study is to evaluate the efficacy and safety of the study drug known~     as dulaglutide when added to sodium-glucose co-transporter 2 (SGLT2) inhibitors in~     participants with type 2 diabetes mellitus.~   "
74094|NCT02597036|"~     The main purpose of this study is to evaluate the safety of the study drug known as LY3127804~     given as monotherapy and in combination with Ramucirumab for participants with advanced or~     metastatic solid tumors. The study will also include a safety exploration for the combination~     of LY3127804 plus ramucirumab and paclitaxel~   "
74095|NCT02597023|"~     The purpose of this study is to assess the efficacy of supplementation with the~     mitochondria-targeted antioxidant, mitoquinone (MitoQ), for improving physiological function~     (vascular, motor, and cognitive) in middle-aged and older adults.~   "
74096|NCT02597010|"~     Acute consumption of dietary nitrate (as beetroot juice) has been shown to decrease systemic~     blood pressure in multiple populations including newly diagnosed, untreated hypertensives.~     The additional effect in hypertensives on blood pressure lowering medications is uncertain.~   "
74097|NCT02596997|"~     Provide patients with serious AdV infection or disease access to treatment with BCV.~   "
74098|NCT02596984|"~     Although the pharmacokinetics of Caspofungin has been studied in healthy subjects and~     patients, only a few studies have been performed in critically-ill patients. In these~     patients several factors, including sepsis, shock, increased distribution volume, hepatic~     dysfunction and hypoalbuminemia may result in dramatic changes in antibiotic concentrations~     and pharmacokinetics. Caspofungin pharmacokinetic data is scarce and are results mainly from~     case series or animal studies. Thus, studies performed so far show Caspofungin trough~     concentrations either decreased, similar to usual value in non-critically ill patients or~     increased. One of these studies suggested that body weight and hypoalbuminemia may be the~     main factors associated with Caspofungin pharmacokinetic variability. Pharmacokinetic~     parameters of caspofungin in pigs with hypovolemic shock suggested the peripheral volume of~     distribution of caspofungin and intercompartmental clearance to be higher than in healthy~     animals. These results are however preliminary and cannot be extrapolated suggesting further~     clinical studies in human to be needed.~      The primary objective of this study is to assess Caspofungin trough concentrations and~     pharmacokinetics in critically-ill patients requiring vasopressors.~   "
74099|NCT02596971|"~     This Phase Ib/II, open-label, multicenter, non-randomized study will evaluate the safety,~     efficacy, and pharmacokinetics of induction treatment consisting of atezolizumab in~     combination with either obinutuzumab + bendamustine (Atezo-G-benda) or obinutuzumab + CHOP~     (Atezo-G-CHOP) in participants with FL and atezolizumab + rituximab + chemotherapy~     (Atezo-R-CHOP) in participants with DLBCL, followed by post-induction treatment consisting of~     either atezolizumab plus obinutuzumab (Atezo-G) in participants with FL who achieve a~     complete response (CR) or partial response (PR) at end of induction (EOI) or atezolizumab~     alone in participants with DLBCL who achieve a CR at EOI.~   "
74100|NCT02596958|"~     The purpose of this non-interventional study is the collection and documentation of data on~     safety and efficacy of intravenous (IV) bevacizumab (Avastin) in addition to platinum-based~     chemotherapy for first-line treatment in participants with unresectable advanced, metastatic~     or recurrent non-small cell lung cancer (NSCLC) other than predominantly squamous cell~     histology with focus on adenocarcinoma and elderly patients in daily routine.~   "
74101|NCT02596945|"~     This non-interventional, observational study investigates the efficacy, safety and usability~     of methoxy polyethylene glycol epoetin beta in participants on peritoneal dialysis.~     Participants who were prescribed methoxy polyethylene glycol epoetin beta by their doctor and~     who meet the selection criteria were to be enrolled and documented in this study for a period~     of 9 months of treatment with methoxy polyethylene glycol epoetin beta with respect to~     efficacy, safety and usability.~   "
74140|NCT02596425|"~     The aim of this clinical trial is to evaluate the efficacy and safety of different~     recruitment maneuvers for reducing postlaparoscopic shoulder pain.~   "
75610|NCT02577263|"~     The primary objective of this trial is to determine the impact of the FOLFOX regimen on~     quality of life and the incidence of chemotherapy induced neurotoxicity.~   "
74102|NCT02596932|"~     Gestational Diabetes Mellitus (GDM) is one of the most common medical complications of~     pregnancy. Neonatal hypoglycemia is a common and well described complication for infants born~     to mothers with GDM and diabetes mellitus (DM) and studies have linked intrapartum maternal~     glucose levels with neonatal hypoglycemia. While guidelines exist to guide practitioners in~     how to best manage intrapartum maternal glucose levels among Type I and and Type II DM, there~     is a paucity of data guiding practitioners in the intrapartum management of blood glucose~     levels for women with GDM, particularly those treated with insulin antepartum. The goal of~     this project is to compare two protocols of intrapartum glucose management in women with GDM~     and investigate the impact on neonatal blood glucose levels.~   "
74103|NCT02596919|"~     Infrared meibography is a useful technique in the evaluation of meibomian gland disease~     (MGD). MGD is a major cause of dry eye symptoms, affecting a large number of patients seen in~     the Corneo-Plastic Unit (CPU). Many parameters have been used to evaluate MGD including tear~     film break-up time, lid margin abnormalities, and Schirmer tear test values. Direct~     visualization of meibomian glands by infrared meibography has been shown to correlate well~     with these parameters.~      Although infrared meibography was developed more than 30 years ago, it is not widely used.~     This has probably been due to the need for special equipment, examiner time and expertise and~     patient discomfort during the examination. Analysis of the acquired images also needed to be~     from video review with extraction of video stills - a time-consuming process.~      Investigators aim to pilot a rapid non-contact (non-painful) method of obtaining infrared~     images of meibomian glands using equipment already available at QVH. This pilot study will~     validate the technique and check patient acceptability. Investigators are hopeful this test~     could be used as a useful tool for future research into dry eye conditions and MGD.~   "
74104|NCT02596906|"~     Individuals aged 55 and older may experience negative effects of cognitive decline. The~     proposed research seeks to evaluate the benefits of different types of interventions:~     reasoning training following transcranial direct current stimulation (tDCS) and reasoning~     training following sham transcranial direct current stimulation (tDCS) on frontal- lobe~     mediated cognitive measures of executive control in adults with memory complaints, in the~     absence of dementia.~   "
74105|NCT02596893|"~     The purpose of study is to test the effects of an experimental medication GED-0301~     (mongersen) in patients who have active Crohn's disease. The study will test GED-0301~     compared to placebo for 52 weeks. The study treatment is blinded which means that patients~     and the study doctor will not know which treatment has been assigned. Patients in this study~     will be allowed treatment with stable doses of oral aminosalicylates, oral corticosteroids,~     immunosupressants and antibiotics for the treatment of Crohn's disease.~      After 12 weeks in the study until the end of the study, patients who do not have an~     improvement in their Crohns disease symptoms will have the option to enter a long term active~     treatment study.~   "
74106|NCT02596880|"~     The investigators will treat 100 patients with cirrhosis due to hepatitis C with sofosbuvir~     400 mg daily, daclatasvir 60 mg daily and weight-based ribavirin (1000 mg/d if <75 kg, 1200~     mg/d if >75 kg, divided in two daily doses) for 12 weeks and calculate the sustained viral~     response rate at 12 weeks.~   "
74107|NCT02596867|"~     This trial is a Phase II study using the window-of-opportunity design in which the~     treatment-free window between breast cancer diagnosis and surgical tumor resection is used to~     study the biological effects of the beta blocker propranolol .~   "
74108|NCT02596854|"~     This study is being conducted for regulatory submission of the GE Healthcare MAGnetic~     resonance Image Compilation (MAGiC), a point-of-care synthetic MR reconstruction software for~     GE 1.5T and 3.0T MR scanners.~   "
74109|NCT02596841|"~     The diagnosis of idiopathic interstitial pneumonia (IIP) is based on computed tomography (CT)~     imaging, whereas lung function studies are used for staging and follow up. Lung diffusing~     capacity for carbon monoxide (DLCO) is generally reduced but weakly correlated with the~     severity of CT-determined fibrotic process. A possible explanation of this finding is that~     DLCO is relatively insensitive to changes in alveolar membrane diffusive conductance (DMCO).~     Lung diffusion capacity for nitric oxide (DLNO) was strongly correlated with CT-determined~     amount of fibrosis/honeycombing in both usual and non-specific interstitial pneumonias.~     Moreover. Both DLNO and DMCO were below the lower limit of normality even in patients with~     small amount of fibrosis. Measurement of DLNO may provide a more reliable assessment of~     fibrotic changes than DLCO because it better reflects DMCO.~   "
74110|NCT02596828|"~     Children, adolescents and young adults with relapsed or treatment refractory pineoblastoma~     (rPB) represent a group of patients with dismal prognosis for whom a recommended standard~     salvage therapy is currently not available.~   "
74111|NCT02596815|"~     The purpose of these study is to compare the effectivity of the Median Nerve Neural~     Mobilization technique to the complete absence of treatment in a group of patients who suffer~     cervicobrachial pain.~   "
74112|NCT02596802|"~     The goal is to study the feasibility and safety of implementing Fetoscopic Endoluminal~     Tracheal Occlusion (FETO) therapy in fetuses with severe left Congenital Diaphragmatic Hernia~     (CDH). The pilot study will determine whether FETO therapy can be performed safely and~     whether it can increase survival and decrease morbidity when compared to standard prenatal~     care for the treatment of severe left CDH.~   "
74113|NCT02596789|"~     This study has two main goals :~        -  to investigate the impact of aging on cortical excitability (CE)~        -  to investigate the impact of state dependency on CE, using a cognitive task and an~          emotional one.~      A Neuronavigation system of transcranial magnetic stimulation is used, and electromyographic~     response are recorded.~   "
74114|NCT02596776|"~     An adaptation to a cold environment is a tendency to generate heat within our body. Some of~     this heat comes from our fat tissue. Although most fat tissue is white fat, there are~     pockets deep within the body that are called brown fat, which are specially adapted to~     burning fat and making heat. The investigator believes that our white fat, just underneath~     the surface of our skin, also has this property to burn fat and make heat, although not at~     the high level of brown fat. This study is to examine this fat-burning property of the white~     fat under the skin in response to seasons and to cold. Many such studies have been done in~     mice, but little has been done in humans.~      There are a number of factors, including age, weight, and medical history, that may make a~     person eligible or ineligible to participate in this study. Certain medications could make a~     person ineligible, but if these medications can be safely altered, the individual may become~     eligible.~   "
74115|NCT02596763|"~     BACLOPHONE is a prospective multicenter cohort study, conducted in two nearby French regions~     (Hauts-de-France and Normandie). BACLOPHONE consists of the monthly phone-based monitoring of~     792 patients during their first year of baclofen prescription for alcohol use disorder.~      The main objective of the study is to determine the rate of patients who stop baclofen due to~     an adverse event (AE) in the first year of treatment.The BACLOPHONE study also aims to~     determine which types of AEs and serious AEs are actually liable to baclofen, and which other~     types are more likely the consequence of confounding factors, e.g., concomitant alcohol,~     psychotropic medications or substance uses, and comorbidities.~   "
74116|NCT02596750|"~     This study evaluates the role of microneedle pretreatment in the speed at which anesthesia~     develops after application of topical 4% lidocaine.~   "
74117|NCT02596737|"~     Individuals spend one third of their life working. Age of retirement is regularly pushed~     back. The main challenge in the nearest future will be to maintain workers health to deal~     with their work till retirement. Morbidity before retirement has a huge cost, both in public~     health and economically for companies. Numerous factors increase morbidity such as stress at~     work, sedentary and low physical activity, and poor nutrition habits. Nowadays, digital world~     wildly invades lives and offer a no-limit possibility to interact with individuals,~     everywhere. Thus, a software able to understand an individual in its globality seems to~     address this challenge. Moreover, managers need to understand the actions needed within their~     company. The objective of WittyFit is to increase life expectancy and well-being. WittyFit~     will constitute a powerful database to build strong evidence and new knowledge on the~     relationships between work, behavior, and health, based on a large amount of epidemiological~     data.~   "
74118|NCT02596724|"~     Prospective observational registry that links results of the genomic and other molecular~     testing to treatment response and survival measures in patients who have been diagnosed with~     breast cancer and who are targeted for neo-adjuvant therapy. Analysis includes how tests~     impact treatment decisions and outcomes.~   "
74119|NCT02596711|"~     The goal of this research study is to learn how 3 different kinds of counseling treatments~     may help individuals to quit smoking.~   "
74120|NCT02596698|"~     This study consists of three separate appointments including a clinical assessment (interview~     and questionnaires), a blood draw, a social stress test, and a brain MRI.~   "
74121|NCT02596685|"~     This randomized pilot clinical trial studies the effects of electronic cigarettes on the~     lungs. Studying the effects of electronic cigarettes on the lungs may provide the Food and~     Drug Administration (FDA) and other government regulators with important information, which~     may help in developing future regulations to make electronic cigarettes safer.~   "
74122|NCT02596672|"~     The multi-level 12 week peer-led walking intervention incorporates aspects from all three~     levels of the ecological model (with the aim of producing sustained (>6months) physical~     activity behaviour change in older adults living in independent living communities.~   "
74123|NCT02596659|"~     Background:~      Tennis elbow, also known as lateral epicondylitis, is the inflammatory status of insertion~     site of common extensor tendon to humerus. It is usually related to overuse of local muscle.~     Radial extracorporeal shock wave therapy (rESWT) is a non-invasive physical treatment. It~     applies shockwave energy to the lesion site, enhancing the growth of microvascularity,~     inducing tissue repair, and thus relieving the symptom.~      The purpose of this study is to understand the therapeutic effect of rESWT to tennis elbow.~      Material and Methods~        -  Subjects: 30 patients will be recruited from outpatient department of physical medicine~          and rehabilitation department.~        -  Duration: 2013.09.01-2015.05.31~        -  Methods: The patients will be randomly divided into the experimental group and the~          control group through the draw, with 15 patients in each group. Patients in the~          experimental group receive rESWT plus routine rehabilitation program. Patients in the~          control group receive sham shockwave therapy plus routine rehabilitation program.~        -  Assessment: Before the therapy starts, patients who match the inclusion criteria will be~          evaluated using tools mentioned below:~        -  General data: age, sex, body height, body weight, affected side, medical history~        -  Assess upper extremity function and symptom with Disabilities of the Arm, Shoulder and~          Hand Questionnaire (DASH)~        -  Assess severity of pain with Visual Analogue Scale (VAS)~        -  Assess grip strength with grip strength dynamometer~        -  Measure the size of tear (if any) of common extensor tendon through ultrasonography, and~          assess the texture of common extensor tendon through real-time sonoelastography (RTS)~      Patients will be followed up 6 weeks, 3months, and 6 months after therapy starts. They will~     be re-assessed of upper extremity function and symptom, severity of pain, grip strength, and~     presentation on ultrasonography and RTS.~   "
74124|NCT02596646|"~     This study evaluates whether an early precut strategy in cases of difficult biliary~     cannulation could reduce the incidence of PEP compared with that after prolonged cannulation~     attempts. Secondary aims are to compare the success of biliary cannulation and complications~     rates of the two techniques.~   "
74125|NCT02596633|"~     This study will investigate the feasibility of running a randomised controlled trial (RCT) of~     a psychotherapy called Acceptance and Commitment Therapy (ACT), delivered in a self-help~     format with additional telephone support from a therapist, for people with Multiple Sclerosis~     (MS) and low mood.~   "
74126|NCT02596620|"~     Asia Pacific Consensus states that levofloxacin-based triple therapy as an alternative~     second-line therapy after Helicobacter pylori (H. pylori) eradication failure when bismuth~     salts are not available. The investigators compare the efficacies of 10-day~     levofloxacin-based sequential therapy and 10-day triple therapy in the treatment for patients~     after failure of standard triple therapy and to determine what clinical and bacterial factors~     influencing the efficacy of salvage regimens.~   "
74127|NCT02596607|"~     Acute stroke management represents a true medical emergency that requires prompt diagnosis~     and urgent treatment. However, only a small percentage of patients access to thrombolysis on~     time. Various actions have been implemented since 2006 in the Rhone area as part of research~     projects and of the 2010-2014 national stroke action plan: training of health professionals~     involved in the stroke management, increase of public awareness through sensibilization~     campaigns, implementation of telemedicine and increase of the number of hospital beds~     dedicated to stroke (stroke units beds).~      The main objective of the STROKE 69 study is to assess the impact of these actions on~     intra-hospital acute stroke management times in the Rhône area. The secondary objectives are~     to assess the impact of these actions on the rate and place of thrombolysis, the rate of~     post- thrombolysis hemorrhage, the rate of thrombectomies, mortality in the acute phase, at 3~     and 12 months, the level of disability at 3 and 12 months, pre-hospital times, the number of~     calls to SAMU centre 15 (French mobile emergency medical services, equivalent to 911) and~     management channels.~      The investigator will perform a prospective cohort study between 06/11/2015 and 06/06/2016~     and data will be compared to data collected in a previous cohorts study, the AVC-69 cohort~     study (Porthault Chatard et al, Int J Stroke. 2012 Oct;7(7):E13), between 06/11/2006 and~     06/06/2007, before the implementation of the actions in the Rhône area.~      The cohort will be constituted of all consecutive patients treated for a stroke suspicion by~     the Rhône SAMU centre 15, or in one of the emergency unit or stroke unit of the Rhône area,~     and presenting a symptom-onset (the last time the patient was seen without deficit) less than~     24 hours.~      After collecting data in the acute phase, patients with a confirmed diagnosis of stroke or~     transient ischemic attack (TIA) will be followed for 12 months after their inclusion by~     telephone calls at 3 and 12 months to assess the level of disability and mortality.~      AVC 69 study allowed us to include 1306 patients between 2006 to 2007, the investigator plan~     to include at least 1300 patients in the STROKE 69 cohort with approximately 1000 confirmed~     strokes or TIAs.~   "
74128|NCT02596594|"~     Placental insufficiency is responsible for fetal loss in about 40% of all stillbirths and~     long term neurological deficits. The mean interval from diagnosis of brain sparing of severe~     IUGR fetuses to delivery has been recently identified by only seven days (Flood K et al, Am J~     Obstetrics and Gynecology 2014).~      The critical placental player in the active amino acids (AA) transport from the mother to the~     fetus is the trophoblast, which is irreversibly changed in severe IUGR fetuses caused by~     placental insufficiency. Thus, a logical partial solution of IUGR could be the direct supply~     of AAs and glucose to the fetus, in order to improve the fetal growth, normalize the fetal~     programming and to prolong the pregnancy.~      The aim of this prospective pilot study is to further test the efficacy of the administration~     of AAs and glucose supplementation with hyperbaric oxygenation (HBO), via a subcutaneously~     implanted intraumbilical perinatal port system, as a treatment option for severe IUGR human~     fetuses with brain sparing.~   "
74129|NCT02596581|"~     The aims of the present study were to determine the gingival crevicular fluid (GCF) chemerin~     and interleukin-6 (IL-6) levels and to analyse the relationship between chemerin and IL-6 in~     periodontal health and in chronic periodontitis (CP) with and without type 2 diabetes~     mellitus (T2DM) as well as to evaluate the effect of non-surgical periodontal therapy on the~     GCF chemerin levels.~   "
74130|NCT02596568|"~     This study will attempt to use a type of non-invasive brain stimulation technology during~     sleep to improve measures of sleep quality and memory in young healthy students and older~     adults. The type of brain stimulation is called transcranial direct current stimulation~     (tDCS), which uses small currents of electricity to increase or decrease the activity of~     specific areas of the brain.~   "
74131|NCT02596555|"~     This prospective, multicenter, multinational, phase IV, interventional single-armed~     (management) trial will focus on the safety, efficacy and cost-effectiveness of a new oral~     anticoagulant in the treatment of patients with acute intermediate-risk PE based on validated~     imaging (echocardiographic or CT angiographic) and laboratory biomarker (circulating levels~     of cardiac troponins and natriuretic peptides) parameters and their combinations.~   "
74132|NCT02596542|"~     Cold-water immersion (CWI) is a frequently applied strategy to accelerate post-exercise~     recovery in both recreational as well as professional athletes. However, the effect of~     repeated post-exercise CWI on other recovery strategies remains unclear.~   "
74133|NCT02596529|"~     The optimal treatment of ankle fractures with involvement of the posterior malleolus remains~     a subject of debate. Despite a large amount of literature on the role of the posterior~     malleolus in a so-called trimalleolar fracture, there are no clear guidelines for its~     treatment. Its size is the leading indication whether fixation of the fragment is necessary~     or not. Most orthopedic surgeons consider a posterior malleolar fracture fragment larger than~     25% to 33% an indication for fixation. Interestingly, after careful evaluation of the~     available literature, there does not seem to be hard evidence for these numbers. It is~     generally accepted that restoration of a normal anatomic mortise and normal tibiotalar~     contact area are key elements for a good functional outcome. Inadequate reduction of the~     posterior fragment may alter the tibiotalar contact area and the joint biomechanics with~     altered stresses in parts of the joint, leading to the development of osteoarthritis and~     worse functional outcome. Traditionally, reduction of these larger fragments is indirectly,~     followed by percutaneous screw fixation in anterior-posterior direction. Disadvantages are~     that it is hard to achieve an anatomical reduction, and that fixation of smaller fragments is~     very difficult. Recently, a direct exposure of the posterior tibia via a posterolateral~     approach in prone position, followed by open reduction and fixation with screws in~     posterior-anterior direction or antiglide plate is advocated by several authors. This~     approach allows perfect visualization of the fracture, articular anatomical reduction, and~     strong fixation. Another advantage is that even small posterior fragments can be addressed.~     Several case series are published, which describe minimal major wound complications, good~     functional outcomes, and minimal need for reoperation. Since 2 years, in our institution we~     perform an open, anatomical reduction and fixation of all medium-sized posterior fragments~     via this approach. Although not thoroughly investigated yet, it seems to lead to better~     clinical outcomes than described in the literature and our retrospective cohort study.~   "
74134|NCT02596516|"~     The aim of this study is to evaluate whether there is a difference in the bile acid content~     in the bowel in patients after right versus left colectomy. There is compelling evidence that~     patients under going resection of the right colon versus left coolon have a lower polyp~     detection rate in surveillance colonoscopies. The investigators intend to evaluate feces of~     patients undergoing left and right colectomies; prior to their surgery and again three and~     six months aftet the surgery. The investigators plan to compare the content of the different~     bile acids and to compare the content between the two groups.~   "
74135|NCT02596503|"~     This IND-exempt Phase I trial will establish the recommended Phase II (RP2D) dose of eribulin~     in combination with fixed doses of oral irinotecan in adolescents and young adults with~     relapsed or refractory solid tumors. Eribulin will be administered intravenously on days 1~     and 8 of a 21-day cycle, while irinotecan will be administered orally on days 1-5.~      Patients will be assigned an eribulin dose level at the time of enrollment using a 3+3 Phase~     I design, and there will be no intrapatient dose escalation. Once the RP2D has been~     established, there will be up to 10 patients enrolled in a dose expansion cohort. In absence~     of disease progression or toxicity, subjects may receive up to 17 cycles of therapy.~   "
74136|NCT02596490|"~     Objectives:~      Our specific aims are to:~      Aim 1: Examine the feasibility of a couple-based meditation program in 50 patients with~     metastatic lung cancer and their partners.~      Aim 2: Establish the initial efficacy of a couple-based meditation program in patients and~     their partners regarding physical, psychological, and spiritual quality of life outcomes.~      Exploratory Aim 1: Explore potential intervention mediators (i.e., mindfulness, compassion,~     holding back, and intimacy) and a moderator (i.e., baseline distress) of the intervention~     effects.~      Exploratory Aim 2: Explore natural language use to assess intervention effects on coping~     processes, posttraumatic growth and optimistic outlook.~   "
74137|NCT02596477|"~     The purpose of this study is to evaluate whether vepoloxamer can provide a blood chemical~     marker and functional benefit to damaged heart muscle cells. This will be evaluated by~     measurement of blood-based laboratory markers, exercise tolerance, and echocardiograms. In~     addition, the safety and blood levels of vepoloxamer in subjects with chronic heart failure~     will be evaluated.~   "
74138|NCT02596451|"~     This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site~     Clinical Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Gel, 1% (Glenmark~     Pharmaceuticals Ltd) to Voltaren® Gel (Diclofenac Sodium topical gel) 1% (Novartis Consumer~     Health, Inc) in Patients with Osteoarthritis (OA) of the Knee~   "
74139|NCT02596438|"~     The Thousand Asian American Study or TAAS aims to test 2,000 foreign-born and children of~     foreign born Asian Americans residing in Sacramento county residents for HBV and (2) counsel~     at least 90% of those whose screening results are positive for HBV.~   "
74141|NCT02596412|"~     Children with cerebral palsy may benefit from treatment with botulinum toxin injections to~     decrease spasticity for improve function and quality of life. These injections cause repeated~     pain throughout childhood and may be the cause of post-traumatic stress despite drug and~     non-drug pain management. The Mini-Docs project of the French Red Cross has a module based on~     a digital device with augmented reality. Distracting the child, the use of this module on a~     tablet would reduce pain felt during botulinum toxin injections.~   "
74142|NCT02596399|"~     This is a Phase 1, randomized, double-blind, placebo-controlled, single-ascending dose study~     in healthy volunteers, enrolled at a single site in the United States to investigate the~     safety, tolerability, and pharmacokinetics of DSTA4637S.~   "
74143|NCT02596386|"~     Dialysis patients typically undergo 3 treatments a week every other day with an almost 3 day~     gap during the weekend. After this gap and before the first dialysis of the week the serum~     Potassium level is expected to be maximal.~      Participants will be recruited from the dialysis clinic at Hadassah Ein Kerem Hospital. The~     research team would personally meet the patients who answer inclusion criteria f and ask~     whether they wish to participate.~      Each willing participant will undergo Sialometry and blood will be drawn from the dialysis~     connections for CBC and Biochemistry to establish a baseline.~      The study measurements namely Sialometry and collection of Saliva as well as blood test will~     be taken before the initiation of the dialysis.~      Blood testing will be done via the laboratories of the Hadassah hospital. Saliva analysis~     will be done in the research lab of Prof. Doron Aframian.~   "
74144|NCT02596373|"~     The hypothesis of this clinical research study is to discover if the study drug Mitoxantrone~     Hydrochloride Liposome Injection can shrink or slow the growth of advanced recurrent or~     metastatic breast cancer~   "
74145|NCT02596360|"~     The aim of this study is to assess the anti-hyperalgesic effect of dextromethorphan in~     healthy volunteers compared to placebo.~   "
74146|NCT02596347|"~     Current studies suggest that alveolar macrophages (AM) act as silencers of most immune~     responses in the lung. However, in pathological conditions, such as asthma, hypersensitivity~     pneumonitis, and sarcoidosis, AMs become involved in the maintenance and further expansion of~     the immune response in the target organ. The Investigator has preliminary data demonstrating~     that CBD AMs at the site of disease involvement (bronchoalveolar lavage, BAL) display an~     activated cell surface phenotype compared to AMs from healthy controls. Furthermore, exciting~     data from our group demonstrates significant differences in gene expression profiles between~     CBD and Beryllium Sensitivity (BeS) bronchial alveolar lavage (BAL) cells, in pivotal immune~     response genes and networks. Specifically, the Investigator has found the JAK/STAT pathway~     and the JAK2 gene was dramatically overexpressed in CBD BAL cells. In addition,~     constitutively phosphorylated JAK2 (pJAK2) was found in AMs from Chronic Beryllium Disease~     (CBD) patients by Westernblot and was increased after beryllium (Be) stimulation for 30 min.~     Moreover, the JAK2 inhibitor TG101348 significantly inhibited Be-induced CBD AMs TNFa and~     IFNy production. Meanwhile, overexpression of the JAK2 inhibitor SOCS 1 (suppressors of~     cytokine signaling) protein decreased Be-induced TNFa production from AMs. Based on this~     information, the Investigator hypothesizes that CBD AMs overexpress JAK2, which augments the~     immune response to Be and development of CBD but not BeS.~      The investigators believe that these studies are highly innovative since they will~     undoubtedly shed light on exposure-mediated immune dysregulation in Alveolar Macrophages~     (AMs) that lead to disease development and likely progression and with additional study of~     this pathway will reveal potential biomarkers for clinical prognosis and diagnosis. The~     results obtained from this study will improve the investigators understanding of factors~     involved in the development of Chronic Beryllium disease (CBD), as well as define targets for~     therapy, and will serve as a model of other exposure-related immune responses and~     environmentally-induced chronic diseases. Most importantly, these studies will provide the~     investigator with preliminary data to submit a high quality R01, allowing the Investigator to~     apply similar approaches to other genes, define a potential target for this and other similar~     immune-mediated diseases and continue research efforts at National Jewish Health (NJH.)~   "
74147|NCT02596334|"~     Triple antiretroviral regimens have greatly improved the prognosis of patients living with~     HIV (PLHIV). Patients virologically controlled and having a good immune restoration can have~     a life expectancy close or equal to that of people not infected with HIV.[1] However, this is~     under the condition of a lifetime maintenance of an undetectable plasma viral load (pVL)~     (<50 cp/ml). On the other hand it is well established that aging increases comorbidities~     among PLHIV and the burden of co-medications.[2] This also has the consequence of frequent~     drug-drug interactions. In this context it is important to decrease pills burden,~     side-effects and drug-drug interactions, while maintaining undetectability.~      Currently, there is a strong interest for medical research to validate lightened regimens~     (i.e. bithérapies [3-7] and monothérapies [8,9], particularly in a maintenance strategy, with~     the primary objective of reducing burden of pills and side effects. Several monotherapy~     trials using a boosted protease inhibitor (PI/r) showed high level of viral suppression, even~     if this proportion was not always non-inferior to maintaining a triple therapy. [8,9]~     Fortunately, when virological failure occurred under monotherapy virologic suppression was~     easily restored by the addition of two NRTI. Patients who are most likely to maintain viral~     suppression under a reduced scheme are those that have a high nadir (> 100 CD4 / mm3), no~     previous AIDS event and a sustained virologic suppression (>12 months).~      Monotherapy is the option that best reduces the burden of pills and the risk of side effects~     or drug-drug interactions. It must be considered using very powerful molecule that harbor a~     strong binding to its ligand in order to minimize the risk of selecting resistant mutants in~     the case of virologic failure. To be as simple as possible in its use, it must be a single~     agent administered as a single dose once a day and not boosted if possible. The molecule must~     have very good tolerance. Finally, to be effective in viral sanctuaries this molecule should~     have a good (or sufficient) diffusion to ensure effective Cmin on wild viral strains.~     Dolutegravir meets all these exigences.[10] In addition, our team recently presented results~     of a pilot study showing that the switch of a successful combined antiretroviral regimen to~     dolutegravir monotherapy maintained undetectable viral load (<20 cp/ml) after a median of 7~     months (range 6.5-10 months).~   "
74148|NCT02596321|"~     To demonstrate superiority of ALK HDM tablets versus placebo in immune response, measured as~     change of D.farinae specific immunoglobulin G4 (IgG4) from baseline to end of treatment with~     ALK HDM tablets given once daily over 60 days.~   "
74149|NCT02596308|"~     Plague is a potentially fatal infection in humans caused by the bacterium Yersinia pestis.~     Pneumonic plague is typically diagnosed in humans with high mortality. It has a long history~     for plague as an agent of biowarfare, and poses a serious threat to international security.~     Althought the killed whole-cell plague vaccine and live attenuated vaccine have been~     licensed, they are rarely used today because of toxicities, limited evidence for efficacy to~     prevent plague, and limited commercial availability. In the last twenty years,the recombinant~     subunit vaccines comprised by fraction 1 capsule(F1)and virulence-associated (V)antigens as~     the main composition have caused widely attention with providing greater protection than~     vaccines comprised of either subunit alone. This study was aimed to explor the safety and~     immunogenicity of a new type plague subunit vaccine which comprised natural F1 antigen and~     recombined V antigen (F1+rV).~   "
74150|NCT02596295|"~     The study will collect human milk from 100 mother of term infants 2-3m after delivery and~     from 50 mothers of preterm infants 14 and 30 days after delivery. Sample content will be~     analysed and statistical analysis will look at correlation between demographics, dietary~     habits and milk composition.~   "
75622|NCT02577107|"~     An exploratory single site, open label, randomized, controlled study evaluated plasma~     vascular endothelial growth factor levels after intravitreal injection of ranibizumab~     (Lucentis) and conbercept (Langmu) for neovascular age-related macular degeneration~   "
74151|NCT02596282|"~     Background: Medical male circumcision (MMC) for HIV prevention is a priority in 14 East and~     Southern African countries, and the long-term sustainability of MMC programs could best be~     achieved by early infant male circumcision (EIMC.) However, the acceptability and safety of~     EIMC provided by non-physicians is unknown.~      Methods: We conducted a trial of EIMC using the Mogen clamp provided by newly trained~     clinical officers (CO) and nurse midwives (NMWs) in 4 health centers in rural Rakai, Uganda.~     501 healthy neonates aged 1-28 days with normal birth weight and gestational age were~     randomized to CO (n=256) and NMWs (n=245), and were followed up at 24 hours, 7 and 28 days.~     Combined analgesia was provided by paracetamol suppository, Eutectic Mixture of Local~     Anesthetics (EMLA) cream and a 24% sucrose solution.~   "
74152|NCT02596269|"~     BACKGROUND : There has been increasing interest on the use of nefopam in i.v.~     patient-controlled analgesia (PCA).~      OBJECTIVE : The aim of this study was to evaluate the opioid-sparing effect of nefopam, when~     administered via i.v. PCA with fentanyl, after laparotomy. The adverse events associated with~     its use were also evaluated, and specific considerations in its clinical use were reviewed.~      DESIGN : A randomized, controlled, single-centre, double-blinded study.~      SETTING : One Korean university hospital.~      PATIENTS : Seventy-one patients planned for elective open laparotomy~      INTERVENTIONS : Patients were assigned into SF (control) or NF group, who received IV PCA~     with fentanyl in normal saline (25 µg/ml), or a solution with 120 mg of nefopam included~     (fentanyl 25 µg/ml and nefopam 1.2 mg/ml), respectively.~      MAIN OUTCOME MEASURES : The pain intensity during the 24 h study period and patient~     satisfaction at the end of the study were evaluated. Adverse events were observed.~   "
74153|NCT02596256|"~     Apatinib plus docetaxel versus docetaxel as second-line treatment in advanced gastric cancer.~   "
74154|NCT02596243|"~     The purpose of this study is to access the efficacy and safety of GX-188E according the~     protocol in patients with Cervical Intraepithelial Neoplasia 2, 2/3 or 3 (CIN3)~   "
74155|NCT02596230|"~     RE-COVERY is a large, multi-national, multi-center observational study based on new data~     collection. The study will enroll and characterize patients within 30 days of being diagnosed~     with an acute DVT and/or PE. The study has two main objectives. Objective 1 will characterize~     the DVT / PE patient population. All patients with a DVT and/or PE will be enrolled for~     cross-sectional characterization of the VTE patient population. Objective 2 will compare the~     safety and effectiveness of dabigatran etexilate regimens for treatment of VTE in comparison~     to VKA regimens. Patients treated with dabigatran etexilate or VKA will be followed up for~     the occurrence of outcome events for up to one year.~   "
74156|NCT02596217|"~     Safety, tolerability and pharmacokinetics of single dose of BI 655066/ABBV-066 (risankizumab)~     in healthy Chinese, Japanese and Caucasian male volunteers.~   "
74157|NCT02596204|"~     With emerging mobile technology, sharing glucose, insulin and sensor data with the clinic for~     frequent and timely monitoring is now feasible. The investigators propose to leverage this~     new technology to provide children and families with appropriate interventions to help manage~     their diabetes.~   "
74158|NCT02596191|"~     This is a 2-year follow-up study of a cohort of 60 CMT1A patients. The objective is to~     identify markers allowing to better understand the phenotypic variability observed on~     patients with CMT1A, to identify predictive markers of the disease's progression and to~     provide validated measurement tools that can be used as outcome measures in future clinical~     trials.~   "
74159|NCT02596178|"~     Lung units that participate in gas exchange are known as 'recruited' lung. Patients with lung~     injury suffer from a proportion of units that do not participate in gas exchange (i.e. the~     derecruited lung), which results in impaired gas exchange and induces an inflammatory~     cascade. The level of PEEP is often coupled to indices of oxygenation such as PaO2, PaO2 to~     FIO2 ratio, or oxygen index. Currently, two strategies are widely accepted and considered~     equivocal, one strategy using a lower PEEP level coupled to a certain oxygen requirement, the~     other using a higher PEEP level.~      The primary purpose of this study is to demonstrate the safety and efficacy of an electrical~     impedance tomography (EIT) PEEP titration protocol designed to recruit collapsed lung in~     children with ARDS and properly maintain lung volumes by setting an optimal PEEP level. A~     safety system has been developed using the ARDSnet FIO2/PEEP High (upper threshold limit) and~     Low (lower threshold limit) algorithm. Efficacy will be defined as an improvement in lung~     volume as assessed by electrical impedance tomography, lung compliance and by an improvement~     in markers of gas exchange. Safety will be defined as the incidence of barotrauma and~     hemodynamic consequences that occur during the protocol. Those results will be compared to~     incidences of barotrauma and hemodynamic compromise within the ARDS literature. Knowledge~     gained from this pilot will be instrumental in developing an EIT imagine guided protocol~     which will allow us to conduct future RCTs utilizing EIT technology~   "
74160|NCT02596165|"~     The significance of parameters of the central hemodynamic is based upon their strong~     association with left ventricular hypertrophy and target organ damage at the heart.~     Noninvasive, auscultatory/ oscillometric and therefore easy applicable measurements of the~     central hemodynamic such as presented by the Schiller BR-102 plus PWA device implicate highly~     promising potential for research and daily clinical praxis for improved cardiovascular risk~     assessment on the population level. The purpose of this study is to evaluate the validity of~     the central and peripheral blood pressure and central arterial stiffness measured with the~     device BR-102 plus PWA from Schiller (Schiller AG, Baar, Switzerland).~   "
74161|NCT02596152|"~     The effects of mini-trampoline training on balance, cardiorespiratory fitness, strength and~     neuropsychological parameters in an overweight or obese population are unknown. The aim of~     this 2-arm randomized controlled trial is to compare the effects of a 12-week mini-trampoline~     training and a 12-week nordic walking training on balance, fitness and strength in~     overweight/obese individuals.~   "
74173|NCT02595996|"~     This is a study to investigate the safety and efficacy of propranolol in the treatment of~     patients with primary lymphedema. The primary goal is to assess patient tolerability of~     increasing doses of propranolol. The secondary goal is to assess lymphedema symptoms and~     signs in response to propranolol treatment.~   "
74174|NCT02595983|"~     The purpose of this study was to evaluate the safety and effectiveness of revusiran~     (ALN-TTRSC) in adults with transthyretin-mediated amyloidosis, whose disease has continued to~     worsen after liver transplantation. Dosing has been discontinued; patients are being~     followed-up for safety.~   "
74162|NCT02596139|"~     The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to~     measure fatigue. It covers the following dimensions: general fatigue, physical fatigue,~     mental fatigue, reduced motivation and reduced activity.~      Fatigue Severity Scale (FSS) contains nine statements that rate the severity of fatigue~     symptoms. The purposes of this study are to translate fatigue questionnaires of -MFI- and~     -FSS- to Taiwan-version, and to examine the reliability and validity of the scales.~      A hundred adult people without diagnosed physical nor mental disabilities will be recruited.~     Subjects will fill out the Taiwan-version of MFI, FSS, SF-36 and Pittsburg Sleep Quality~     Index (PSQI) to establish the validity. Subjects will re-fill the MFI and FSS one week later~     to evaluate the test-retest reliability.~      Another twenty people who are familiar with both English and Chinese will be recruited to~     evaluate the translation reliability. Subjects will fill out the English version of MFI and~     FSS and, then, fill out the Taiwan-version of the MFI and FSS with at least ten minutes~     apart. The translation reliability will be evaluated by paired t test and the intraclass~     correlation coefficient.~   "
74163|NCT02596126|"~     The purpose of this study is to evaluate the efficacy of a polypill strategy containing~     aspirin (100 mg), ramipril (2.5, 5 or 10 mgs), and atorvastatin (40 mgs) compared with the~     standard of care (usual care according to the local clinical practices at each participating~     country) in secondary prevention of major cardiovascular events (cardiovascular death,~     nonfatal myocardial infarction, nonfatal ischemic stroke, and urgent revascularization) in~     elderly patients with a recent myocardial infarction.~   "
74164|NCT02596113|"~     The investigators designed a prospective study to evaluate the predictive ability of~     detection of mutations in genes involved in carcinogenesis of the colon (eg hMLH1, K-Ras,~     B-Raf, ccfDNA) in a sample of Greek population presents for conducting colonoscopy in the~     context of screening under international CRC prevention instructions. This investigation will~     be carried out in individuals in normal risk in order to study specific mutations (in blood~     and tissue) to draw reliable conclusions about whether we can detect (with greater~     sensitivity and specificity) patients with precancerous lesions or CRC with a simple blood~     test thereby reducing the cost and side effects of repeated endoscopic procedures.~   "
74165|NCT02596100|"~     This is a single center open label randomized 4-period 2-sequence replicated crossover design~     study. A total of 52 healthy subjects will be randomized.~   "
74166|NCT02596087|"~     The overall goal of the IQ-MAPLE project is to improve the quality of care provided to~     patients with several heart, lung and blood conditions by facilitating more accurate and~     complete problem list documentation. In the first aim, the investigators will design and~     validate a series of problem inference algorithms, using rule-based techniques on structured~     data in the electronic health record (EHR) and natural language processing on unstructured~     data. Both of these techniques will yield candidate problems that the patient is likely to~     have, and the results will be integrated. In Aim 2, the investigators will design clinical~     decision support interventions in the EHRs of the four study sites to alert physicians when a~     candidate problem is detected that is missing from the patient's problem list - the clinician~     will then be able to accept the alert and add the problem, override the alert, or ignore it~     entirely. In Aim 3, the investigators will conduct a randomized trial and evaluate the effect~     of the problem list alert on three endpoints: alert acceptance, problem list addition rate~     and clinical quality.~   "
74167|NCT02596074|"~     To assess the pharmacodynamics, safety/tolerability and efficacy of topical Omiganan (CLS001)~     in patients with usual type vulvar intraepithelial neoplasia (uVIN).~   "
74168|NCT02596061|"~     This study aims to examine whether a combination of positive and negative commitment devices~     is effective at inducing long-term smoking cessation in smokers from a low-to-moderate income~     background. Investigators will randomly assign patients of a multi-site clinic in Connecticut~     to receive one or both of a succession of two commitment contracts. First, a two-month reward~     contract will pay participants for (a) engaging in clinic and web-based activities that~     support smoking cessation and (b) quitting smoking, as measured at period end. Second, a~     four-month deposit contract will invite participants to commit funds which they forfeit~     unless they abstain from smoking over the entire period. A random subset of participants will~     also have the option to pre-commit to the deposit contract at study enrollment. Reward payout~     and deposit recovery will be conditional on biochemical verification of self-reported~     abstinence. Investigators will conduct follow-up biochemical verification at 12 months to~     observe whether abstinence persists after removal of incentives. The primary outcome of~     interest will be continuous abstinence from smoking between months 2 and 12, i.e.~     biochemically verified abstinence at all three measurements. A short baseline and endline~     survey will also be administered to measure characteristics and outcomes related to smoking~     behavior.~   "
74169|NCT02596048|"~     This is a Phase IV multicenter, open-label study and is being implemented in order to assess~     diagnostic image quality of MDCTA in subjects undergoing computed tomography angiography~     (CTA) of the thoraco-abdominal aorta, and the carotid, pulmonary and peripheral arteries with~     IOMERON.~   "
74170|NCT02596035|"~     This study will generate safety data on Nivolumab given by itself in treatment of advanced~     Renal Cell Carcinoma (RCC). The primary objective of this study is to assess immune related~     side effects, also known as immune-mediated adverse events (IMAEs), in patients treated with~     Nivolumab.~   "
74171|NCT02596022|"~     Repeated drug consumption may progress to problematic use by triggering neuroplastic~     adaptations that attenuate sensitivity to natural rewards while increasing reactivity to~     craving and drug cues. Converging evidence suggests that glutamate modulation may work to~     correct these adaptations and rapidly restore motivation for delayed non-drug rewards~     relative to immediate drug use. Using an established laboratory model aimed at evaluating~     behavioral shifts in the salience of cocaine now vs. money later, the investigators will test~     the effect of CI-581a on cocaine self-administration as compared to the active control.~   "
74172|NCT02596009|"~     The purpose of this study is to compare dynamic inspiratory flow rates achieved by a~     population of Chronic Obstructive Pulmonary Disease (COPD) patients through the Breezhaler®,~     Ellipta® and Handihaler® dry powder inhaler (DPI) devices. No active drug or placebo will be~     administered to patients in this study.~   "
75623|NCT02577094|"~     Determination of the maximum tolerated dose (MTD) of fractionated RIT with epratuzumab~     radiolabeled with yttrium-90 (90Y-epratuzumab) preceding a reduced conditioning regimen FB2A2~     before allogeneic stem cell transplantation.~   "
74176|NCT02595957|"~     Background:~      Genes are the instructions a person s body uses to function. Genome sequencing is a new way~     to look at genes that your main research team is using to learn the causes of the condition~     they are studying. When a new cause is found this way, it is called a primary variant. Each~     person has many variants. Most do not cause disease. Sequencing can also find secondary~     variants. These are not related to the condition your main research team is studying, but may~     show a person to be at high risk for cancer or another condition. Researchers want to learn~     more about what it means to have a secondary variant.~      Objectives:~      To find new gene changes that lead to certain medical conditions. To better understand the~     causes of certain diseases. To learn about how people understand their genetic test results.~      Eligibility:~      People with rare diseases who have already consented to and enrolled in another protocol run~     by a group other than the National Human Genome Research Institute.~      Design:~      DNA samples that were already collected will be studied.~      Participants may be asked to send in a second DNA sample (blood or saliva). These will be~     used to verify any findings.~      If a primary variant for the participant s health condition is found through genome~     sequencing, this will be shared with the participant by their primary research team.~      If the participant has a secondary finding, it will be shared by phone call or~     videoconference by this research group in the National Human Genome Research Institute. Some~     participants may get their results in person at the clinic.~      Three months after getting their secondary findings, participants will do an online survey~     and phone interview. They will be asked about how they have used the information.~      Some people who do not receive a secondary finding from genome sequencing will be asked to do~     an online survey three months after the get that result.~      Participants who have a secondary finding can get genetic counseling.~   "
74177|NCT02595944|"~     This phase III ALCHEMIST trial studies how well nivolumab after surgery and chemotherapy work~     in treating patients with stage IB-IIIA non-small cell lung cancer. Monoclonal antibodies,~     such as nivolumab, may stimulate the immune system in different ways and kill tumor cells~     remaining after surgery and standard of care chemotherapy.~   "
74178|NCT02595931|"~     This phase I trial studies the side effects and best dose of ATR kinase inhibitor VX-970 and~     irinotecan hydrochloride in treating patients with solid tumors that have spread to other~     places in the body and usually cannot be cured or controlled with treatment (advanced) or~     cannot be removed by surgery. ATR kinase inhibitor VX-970 and irinotecan hydrochloride may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
74179|NCT02595918|"~     This pilot phase I trial studies the side effects of nivolumab and how well it works in~     treating patients with high-risk kidney cancer that has not spread to other places in the~     body. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells~     to grow and spread.~   "
74180|NCT02595905|"~     This randomized phase II trial studies how well cisplatin works with or without veliparib in~     treating patients with triple-negative breast cancer and/or BRCA mutation-associated breast~     cancer that has come back or has or has not spread to the brain. Drugs used in chemotherapy,~     such as cisplatin, work in different ways to stop the growth of tumor cells, either by~     killing the cells, by stopping them from dividing, or by stopping them from spreading.~     Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. It is not yet known if cisplatin is more effective with or without veliparib in~     treating patients with triple-negative and/or BRCA mutation-associated breast cancer.~   "
74181|NCT02595892|"~     This randomized phase II trial studies how well ATR kinase inhibitor M6620 (M6620) and~     gemcitabine hydrochloride work compared to standard treatment with gemcitabine hydrochloride~     alone in treating patients with ovarian, primary peritoneal, or fallopian tube cancer that~     has come back after a period of improvement (recurrent). ATR kinase inhibitor M6620 may stop~     the growth of tumor cells by blocking an enzyme needed for cell growth, and may also help~     gemcitabine hydrochloride work better. Gemcitabine hydrochloride is a drug used in~     chemotherapy that works to stop the growth of tumor cells by blocking cells from growing and~     repairing themselves, causing them to die. It is not yet known whether adding ATR kinase~     inhibitor M6620 to standard treatment with gemcitabine hydrochloride is more effective than~     gemcitabine hydrochloride alone in treating patients with ovarian, primary peritoneal, or~     fallopian tube cancer.~   "
74182|NCT02595879|"~     This phase I trial studies the side effects and best dose of triapine when given with~     radiation therapy and cisplatin in treating patients with stage IB2-IVA cervical or vulvar~     cancer. Triapine may stop the growth of cancer cells by blocking an enzyme needed for cell~     growth. Cisplatin is a drug used in chemotherapy that kills cancer cells by damaging their~     deoxyribonucleic acid (DNA) and stopping them from dividing. Radiation therapy uses~     high-energy x-rays to kill tumor cells and shrink tumors. Adding triapine to standard~     treatment with cisplatin and radiation therapy may kill more cancer cells.~   "
74183|NCT02595866|"~     This phase I trial studies the side effects of pembrolizumab in treating patients with human~     immunodeficiency virus (HIV) and malignant neoplasms that have come back (relapsed), do not~     respond to treatment (refractory), or have distributed over a large area in the body~     (disseminated). Monoclonal antibodies, such as pembrolizumab, may block tumor or cancer~     growth in different ways by targeting certain cells. It may also help the immune system kill~     cancer cells.~   "
74184|NCT02595853|"~     Hemospray™ is a new endoscopic hemostatic powder. Aims of this multicenter prospective study~     is to determine effectiveness of Hemospray™ on short and medium term in different clinical~     situations, predictive factors of rebleeding after Hemospray™ application, and feasibility of~     the application of hemostatic powder in routine clinical practice studying in a large sample~     of patients.~   "
74185|NCT02595840|"~     The aim of Trans-MARBLE is to identify and validate novel biomarkers of response and~     resistance to maintenance therapy with afatinib or pemetrexed in patients with EGFRmutated~     non-small-cell lung cancer who have progressed after first-line therapy with afatinib.~   "
74186|NCT02595827|"~     Providers in integrated Community Case Management (iCCM) programs in low resource settings~     often see children without any danger signs, presenting with fever but not having pneumonia,~     malaria, or diarrhea. These children are sent home (often with analgesic only), and~     caretakers are advised to return in 2 or 3 days. In this study, we are evaluating if~     conditional return advice (i.e. return in 2 or 3 day only if your child is still sick)~     results in the same proportion of children remaining with fever one week after~     identification, as the current universal return advice.~   "
74187|NCT02595814|"~     The clinical characteristics, initial presentation, management, and outcomes of patients~     hospitalized with new-onset (first diagnosis) heart failure (HF) or decompensation of chronic~     HF are poorly understood worldwide. REPORT-HF is a global, prospective, and observational HF~     disease registry designed to characterize patient trajectories longitudinally during and~     following an index hospitalization for acute HF.~   "
74228|NCT02595281|"~     HE4 is a more sensitive marker than CA-125 in patients with ovarian cancers. The interest of~     serum HE4 before surgery has been demonstrated to predict overall survival and its interest~     has also been shown in combination with CA-125 (ROMA algorithm) to identify high risk~     patients. To date, no study shows clearly the predictive potential of serum HE4 as an early~     relapse biomarker in ovarian cancers.~   "
74188|NCT02595801|"~     The central hypothesis is that surgery and anesthesia exposure in children with immature~     structural and functional brain development has long-term adverse effects on child~     development at school-entry compared with children not exposed to anesthesia.~      The secondary hypothesis is that frequency of surgery and anesthesia exposure in children~     with immature structural and functional brain development has a dose-dependent association~     with worsened child development outcomes at school-entry.~      The overall objective is to investigate the association between surgery/anesthesia~     exposure(s) in children in Ontario and major child development outcomes (physical health and~     well being, social competence, emotional maturity, and language and cognitive development) at~     school entry as measured by the Early Development Instrument.~   "
74189|NCT02595788|"~     Transoesophageal ultrasound examination before and after prone position.~   "
74190|NCT02595775|"~     This project aims to measure the impact of a physician report card (also called an audit &~     feedback report) on colonoscopy performance. Endoscopists in Ontario will be randomly~     assigned to either receive the endoscopist report card or to no feedback. Using Ontario~     health administrative data, the quality of colonoscopy will be compared between those who~     received the report card and those who do not. The investigators will also measure the effect~     of receiving endoscopist report card on colonoscopy performance amongst endoscopists who~     perform poorly at baseline compared to those who do not. Further, the acceptability of two~     educational interventions that aim to improve the quality of colonoscopy will be evaluated by~     conducting one-on-one interviews with select participants. This study is critical to ensure~     that Canadians have access to the highest quality colonoscopy possible.~   "
74191|NCT02595762|"~     This disease registry is a prospective, multicenter non-interventional study designed to~     observe anti-cancer treatment regimens and clinical outcomes in participants with~     HER2-positive unresectable locally advanced breast cancer (LABC) or metastatic breast cancer~     (MBC).~   "
74192|NCT02595749|"~     Socioemotional processing dysfunctions (i.e., disruptions in affective, cognitive, and neural~     processes that encode, interpret, and respond to socially and emotionally relevant stimuli)~     have been implicated in tobacco smoking and relapse, however this potential target for~     medication development has not been systematically examined. Evidence from animal and human~     laboratories indicate that administration of intranasal oxytocin enhances socioemotional~     processing and may be efficacious for the treatment of drug addiction, including nicotine~     dependence. In order to evaluate the potential efficacy of intranasal oxytocin for smoking~     cessation, this laboratory-based proposal will examine whether intranasal oxytocin attenuates~     smoking lapse, nicotine withdrawal, and socioemotional processing disruptions in regular~     smokers following overnight abstinence.~   "
74193|NCT02595736|"~     The purpose of this study is to look at the safety and tolerability of single doses of~     LY3200327 when given to healthy male and female participants either by injection under the~     skin or by drip into a vein. The study will help determine how the drug behaves inside the~     body and how long it takes to disappear from the body. The study will also look for anti-drug~     antibodies and how these may affect how LY3200327 acts in your body.~      The study is expected to last approximately 12 weeks (with screening evaluations up to 4~     weeks prior).~   "
74194|NCT02595723|"~     This study is designed to test if megestrol acetate induces changes in declarative memory in~     healthy controls and if pre-administration of phenytoin can ameliorate any induced cognitive~     impairments.~   "
74195|NCT02595710|"~     Approximately 20 volunteers who have received a liver transplant and have been diagnosed with~     cryptogenic cirrhosis will be included in this study. Blood, skin and urine samples will be~     analyzed for Bartonella spp..~   "
74196|NCT02595697|"~     The goal of this study is to conduct an efficacy trial to determine whether an early~     communication intervention which blends two evidence-based interventions, Enhanced Milieu~     Teaching (EMT) and Joint Attention, Symbolic Play and Regulation Intervention (JASPER),~     improves social communication in toddlers with Autism Spectrum Disorder (ASD).~   "
74197|NCT02595684|"~     Obesity is a chronic disease of multifactorial etiology that develops from the interaction of~     the influence of nutritive , metabolic , cellular and molecular psychological factors.~      Tadalafil is Is a drug inhibiting the enzyme phosphodiesterase-5 (PDE-5), responsible for~     inactivating the vasodilator nitric oxide. USING paragraph was mainly treat erectile~     dysfunction, and recently approved for the treatment of pulmonary hypertension , it is~     innovative because of its longer life means, provides efficacy after 36 hours and the highest~     selectivity.~      The aim of this study is to evaluate the effect of tadalafil on insulin sensitivity and~     insulin secretion in obese men.~      The investigators hypothesis is that the administration of tadalafil improve the insulin~     sensitivity and insulin secretion in obese men.~   "
74198|NCT02595671|"~     The purpose of this study is to carry out a field trial to evaluate the effectiveness and~     added value of the b-SLIM digital Super Coach in a convenient sample of overweight and obese~     adults.~   "
74208|NCT02595541|"~     Pulmonary hypertension (PH) is a consequence of an increase in pulmonary vascular resistance~     (PVR), pulmonary blood flow, pulmonary venous pressure, or a combination of these elements.~     Pulmonary arterial hypertension is a frequent complication of congenital heart disease,~     particularly in patients with systemic-to-pulmonary shunts. Persistent exposure o f the~     pulmonary vasculature to increased blood flow and pressure may result in vascular remodeling~     and dysfunction. This leads to increased pulmonary vascular resistance and, ultimately, to~     reversal of the shunt and development of Eisenmenger's syndrome. It may be more appropriate~     to define pulmonary hypertension according to the ratio of MPAP to mean systemic arterial~     pressure (MPAP/MAP) because children may have a low mean systemic blood pressure. MPAP/MAP~     ratio of < 0.25 is normal, a ratio of 0.33-0.5 indicates moderate pulmonary hypertension, and~     a ratio of > 0.5 is indicative of severe pulmonary hypertension~   "
74209|NCT02595528|"~     This study will identify the optimum concentrations of AGN-199201 and AGN-190584 when dosed~     in combination once a day for the improvement of uncorrected near visual acuity in~     participants with presbyopia (inability to focus on items close-up).~   "
74229|NCT02595268|"~     The purpose of this study is to evaluate the effect of steady-state concentrations of~     JNJ-63623872 on the single-dose pharmacokinetics of pitavastatin in healthy participants.~   "
74199|NCT02595658|"~     People with Type 1 diabetes (T1DM) are usually provided guidance on how best to control~     glycaemia around meal times through adjusting their rapid-acting insulin dose according to~     the carbohydrate content of the meal (e.g. 1 IU per 10/15 g of carbohydrate; Schmidt et al.,~     2014). However, a potential issue around this method is the role of dietary fat in the~     calculation of insulin requirements (Wolpert et al., 2013). The fat component of the meal has~     the potential to influence the insulin dose requirement to normalise postprandial glycaemia~     (Wolpert et al., 2013). Although normalising postprandial glycaemia is vital, postprandial~     lipaemia is also an important consideration for long-term health, and at present there is~     scant data in this area in T1DM. In addition, changing the macronutrient composition of foods~     and altering insulin doses may carry important implications for vascular function and~     prospective appetite regulation.~      This research will examine the glycaemic and lipaemic responses after consuming a mixed meal~     similar in carbohydrate content, but differing in fat content. Moreover, this research will~     assess whether acute postprandial reductions in insulin sensitivity can be offset through~     increasing the dose of rapid-acting insulin for such meals. Venous blood samples will be~     collected before and for 6 hours after meals, for the determination of glycaemic and lipaemic~     responses, as well as metabolite and hormonal parameters. In addition this study will assess~     the impact of mixed meals and adjusting insulin dose on vascular function and subjective~     ratings of appetite.~      The findings from this study will benefit patients with type 1 diabetes by the provision of~     more refined self-management strategies for insulin dosage around meal-times.~   "
74200|NCT02595645|"~     Colorectal cancer ist the 2nd most leading cancer among men and women in germany. Screening~     colonoscopy has the potential to detect premalignant lesions. By endoscopical resection of~     these lesions, colorectal cancers could be avoided. The decision for surveillance is made~     according to patients medical history, amount and histological characteristics of the~     resected polyps. Molecular guided decisions are still missing. Thus, further tools and~     mechanisms, beyond but in addition to endoscopy and histopathological, are strongly required~     to reduce such interval carcinomas and get a better and deeper inside into molecular~     alterations which occurs in premalignant lesions in the colon and describe risk populations~     which might benefit from shorter surveillance strategies by colonoscopy. Therefore GENESIS~     will enroll 100 patients, which underwent screening colonoscopy with polyp ectomy. All~     biopsies were stored and processed without formalin in special boxes (PaxGene by Qiagen®).~     After microdissection of polyp tissue and isolation of DNA targeted next generation~     sequencing of 38 cancer-related genes followed by bioinformatics and systems biology~     analyses. The sequencing results were correlated to the endoscopical and histopathological~     findings. In parallel we are collecting EDTA-blood samples for analysis of circulating~     cell-free DNA (cfDNA) to investigate the potential of liquid biopsies in premalignant~     colorectal lesions.~   "
74201|NCT02595632|"~     The purpose of this study is to detect a specific profile of breath in healthy subjects by an~     untargeted metabolomic study using exhaled breath analysis by mass spectrometry.~   "
74202|NCT02595619|"~     This study aims to assess whether in patients with acute kidney injury (AKI) requiring~     mechanical ventilation, a strategy that combines renal replacement therapy (RRT) and~     extracorporeal carbon dioxide removal (ECCO2R) allows reduction of tidal volume and plateau~     pressure. Systemic Inflammatory Response and Safety Variables will also be analysed.~   "
74203|NCT02595606|"~     A randomized parallel controlled study was designed to compare the efficacy of 0.3% Sodium~     Hyaluronate in the treatment of Dry Eye of diabetic patients.~   "
74204|NCT02595593|"~     This is a multicenter randomized study investigating the differences in clinical outcomes of~     patients between two standard of care pathways for rib trauma: patients who receive rib~     fixation versus patients who receive modern critical care and pain control after sustaining~     clinically significant rib fractures from trauma.~   "
74205|NCT02595580|"~     Diabetes mellitus type 1 (DM1) is an autoimmune metabolic disease in which the insulin~     producing cells in the pancreas are destroyed and the subject is left totally dependent of~     external supply of insulin. There is no known cure for DM1 except for in very specific~     situations. Thus, management of DM1 concentrates on keeping blood glucose levels as close to~     normal levels.~      As an aid to subjects with DM1 for managing their blood glucose levels as close to normal as~     possible, blood glucose monitoring systems have been developed. Available blood glucose~     monitoring systems today require a capillary blood sample that is analysed by a glucose~     meter. Subjects are normally advised by health care professionals on the appropriate blood~     glucose monitoring regime for their condition. However, many subjects fail to measure blood~     glucose as often as needed to achieve good blood glucose control despite every effort from~     health care professionals.~      Research and development of non-invasive interstitial blood glucose monitoring methods is~     ongoing. All attempts to develop a non-invasive continuous glucose measuring device have so~     far failed. Prediktor Medical AS has developed a non-invasive sensor, GlucoPred, based on the~     combination of several non-invasive measurement principles and multivariate analysis and~     dynamic models of glucose/insulin interaction. The device will be body mounted in the form of~     a bracelet or a watch communicating with a mobile phone or a tablet for data presentation and~     collection. Development of GlucoPred is now at a stage where testing of the sensor in~     subjects under controlled settings is required before further development can take place.~      If successful, this will be a major step ahead for all patients with diabetes and markedly~     increase their possibility to take care of their disease on a day to day basis without the~     burden of frequent blood sampling or wearing an invasive device.~   "
74206|NCT02595567|"~     The purpose of this study is to evaluate the effectiveness of an indwelling tunneled pleural~     catheter (ITPC) in the management of hepatic hydrothorax that is not responsive to~     conventional medical therapy. Hepatic Hydrothorax (HH) is defined as an accumulation of fluid~     in the pleural space between the chest wall and the lung and occurs in 5-10% of patients with~     liver disease. Despite medical therapy with diuretics and salt restriction, many patients~     still experience intractable, debilitating shortness of breath, often necessitating hospital~     admission. Repeated thoracentesis,which is a procedure in which the hepatic hydrothorax is~     drained with a needle may be effective, but is often only temporary prior to the~     reaccumulation of fluid leading to the requirement of repeated procedures. Trans-jugular~     intrahepatic porto-systemic shunt (TIPS), while a valuable treatment for HH, is not always~     effective or able to be performed. Similarly, liver transplantation although potentially~     curative, is not available to many patients and may be significantly delayed. Many patients~     do not experience sufficient or timely relief with current conventional therapy.~   "
74207|NCT02595554|"~     Neoadjuvant chemotherapy (NACT) and radical surgery (RS) may have a possible better outcome~     to concurrent chemoirradiation (CCRT) in stage IIB cervical cancer. We try to verify such a~     hypothesis in terms of survival and treatment related morbidity.~   "
74210|NCT02595515|"~     Infantile colic is condition that affects more than 10% of babies and their families. The~     reason, and hence proper treatment, for this condition is unknown and many causes have been~     suggested. One of the treatments that parents choose is chiropractic manipulation. In~     Denmark, almost 10,000 babies are each year treated by chiropractors, and a high proportion~     is due to colic. However, the effect of chiropractic treatment of infantile colic has not~     been properly scientifically evaluated.~      The effects of chiropractic treatment on infantile colic needs to be investigated, since this~     is a very common disorder with no known effective treatment, but with good empirical evidence~     of the value of chiropractic treatment. Although it is usually considered to be a benign and~     self-limiting condition, some studies suggest there might be long-term effects in terms of~     psychomotor problems. In worst case, the infants' crying may also lead to violence and~     'shaken baby syndrome'.~      Null hypothesis: There is no effect of chiropractic treatment on the course of infantile~     colic.~      This study is a controlled, clinical trial where infants fulfilling the diagnostic criteria~     for colic will be randomized into two groups. One group will receive treatment and the other~     won't. This will determine the overall effect and furthermore, subgroup analyses will be~     performed to identify possible subgroups of infants, who will benefit the most from the~     treatment.~   "
74211|NCT02595502|"~     The purpose of this investigation is to evaluate the short-term, clinical performance of two~     silicone hydrogel daily disposable contact lenses.~   "
74212|NCT02595489|"~     In this pilot study, the investigators will assess the safety of two high-dose regimens of~     oral vitamin D supplementation and measure the effects of vitamin D supplementation on~     markers of oxidative stress and inflammation in the blood and brain of study participants~     before, during, and after taking vitamin D supplements.~      The goal of the study is to establish research measures (i.e. biomarkers) and an optimal dose~     for vitamin D supplementation in boys with the X-linked adrenoleukodystrophy (ALD) genotype.~   "
74213|NCT02595476|"~     A standardized tetanic stimulation is applied to patients under propofol-remifentanil TCI, in~     a cross-over fashion, at two different levels of anesthesia monitored by the BIS: BIS 25 and~     BIS 55. Remifentanil target remains constant during the whole study period (1 ng/ml).~     Pupillary reflex dilation is recorded after each stimulation.~   "
74214|NCT02595463|"~     The purpose of this study is to determine whether giving lidocaine intravenously during and~     after a tonsillectomy surgery is effective in decreasing postoperative pain.~   "
74215|NCT02595450|"~     This is a non-interventional, open label, single arm, multicenter study to assess the safety~     and efficacy of erlotinib in participants with non-small cell lung cancer.~   "
74216|NCT02595437|"~     The main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered~     intravenously in pediatric patients with chronic kidney disease on chronic hemodialysis~     (CKD-5HD). It is an open-label, two-period sequential dosing study.~   "
74217|NCT02595424|"~     This randomized phase II trial studies how well temozolomide and capecitabine work compared~     to standard treatment with cisplatin or carboplatin and etoposide in treating patients with~     neuroendocrine carcinoma of the gastrointestinal tract or pancreas that has spread to other~     parts of the body (metastatic) or cannot be removed by surgery. Drugs used in chemotherapy,~     such as temozolomide, capecitabine, cisplatin, carboplatin and etoposide, work in different~     ways to stop the growth of tumor cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Certain types of neuroendocrine carcinomas may~     respond better to treatments other than the current standard treatment of cisplatin and~     etoposide. It is not yet known whether temozolomide and capecitabine may work better than~     cisplatin or carboplatin and etoposide in treating patients with this type of neuroendocrine~     carcinoma, called non-small cell neuroendocrine carcinoma.~   "
74218|NCT02595411|"~     The aim of the study is to investigate the reliability of the Melbourne Assessment.~   "
74219|NCT02595398|"~     The study is designed to evaluate the safety and efficacy of suprachoroidally administered~     triamcinolone acetonide, CLS-TA, in subjects with macular edema associated with~     non-infectious uveitis.~   "
74220|NCT02595385|"~     The aim of this study is to compare retrograde autologous priming (RAP) of the bypass circuit~     to cell salvage (CS) as part of blood conservation strategies in adult cardiac surgery. It~     hypothesizes that RAP is at least as effective as cell salvage in terms of blood conservation~     but at the same time more cost effective.~   "
74221|NCT02595372|"~     In preliminary laboratory science studies, the investigators show that proton pump inhibitors~     (PPIs) effectively inhibit human fatty acid synthase (FASN) and breast cancer cell survival.~     A preliminary retrospective study shows that PPI usage in breast cancer patients during~     chemotherapy significantly improved overall survival. The impact was most striking in~     patients with triple negative breast cancer (TNBC). Thus, PPIs may be repositioned as safe~     and effective breast cancer drugs to enhance the effect of chemotherapy.~      Many of the hurdles that slow progress from target, to lead compound, to investigational~     agent, to standard therapy are not barriers for the PPIs. The PPIs are FDA-approved,~     chronically used, and well tolerated so the investigators can move quickly from the~     laboratory to a proof of concept clinical trial. Incorporating the PPIs into standard care~     will require more than the investigators propose here, but the investigators have already~     plotted the additional steps needed to truly impact patient care. If successful, the data~     gathered in this proposal will lend support to and guide development of a definitive~     randomized trial.~   "
74222|NCT02595359|"~     The aim of this study was to evaluate the efficacy and safety of the prophylactic effect of~     intracameral moxifloxacin for prevention of postcataract endophthalmitis.~   "
74223|NCT02595346|"~     This study evaluates the benefits of hydroxychloroquine on arterial function in~     antiphospholipid syndrome.~      Briefly, the patients will be randomized in two groups, one will receive hydroxychloroquine~     and standard treatment, the other will receive placebo in addition of standard treatment.~   "
74224|NCT02595333|"~     This study aims to compare the pain degree between primary cesarean section and repeated~     cesarean section, and investigate the role of flurbiprofen axetil in postoperative analgesia,~     so as to provide reference for clinical practice.~   "
74225|NCT02595320|"~     The purpose of this study is compare different doses of capecitabine to see if one is better~     than the other in terms of efficacy and toxicity.~   "
74230|NCT02595255|"~     While most of the children spontaneously recover menstruation or experienced normal puberty~     after chemotherapy, their ovarian reserve may be impaired by treatment inducing future~     infertility. Fertility preservation is currently proposed for selected prepubertal patients~     with a high risk of premature ovarian failure after treatment (mostly conditioning regimen~     for bone marrow transplantation). For patients with low or moderate risks, counselling is~     very difficult and no fertility preservation procedure is usually proposed for these patients~     as no marker of the ovarian reserve has been validated in this young population to assess the~     individual risk.~      The primary objective of the study is to prevent long-term treatment-related infertility by~     detecting the young patients who normally progressed to menarche but have a reduced ovarian~     reserve. These patients may benefit from particular follow-up and fertility preservation~     procedure.~   "
74231|NCT02595242|"~     The purpose of this study is to determine whether Mitoxantrone Hydrochloride Liposome~     Injection plus Cyclophosphamide,Vincristine and Prednison(CNOP)is safe and effective in the~     treatment of Diffuse Large B Cell Lymphoma.~   "
74232|NCT02595229|"~     Investigation of the influence of the pronator quadratus (PQ) muscle repair following volar~     plate fixation of distal radius fractures with regard to the forearm pronation strength.~     During the early recovery period of 3 months an improvement of pronation strength and~     functional scorings was hypothesized for the PQ repair when compared to no repair.~      Randomization of the patients in two groups ( PQ repair and no repair) and follow-up~     examinations after 6 and 12 weeks included bilateral isometric pronation strength~     measurement, range of motion, the QuickDASH and the Mayo-Wrist-Score, and a visual analogue~     scale (VAS)~   "
74233|NCT02595216|"~     Prospective clinical study to evaluate the Profound efficiency Up to 60 healthy adult~     volunteers, male or females, 18 to 70 years old. All subjects in this study will receive a~     single treatment to the submental area with the profound device; subjects will return to four~     follow- up visits: 1 week post treatment, 1, 3 and 6 months post treatment.~      Prior to treatment, tissue will be treated with injected tumescence or local dermal~     infiltration solution according to the protocol.~   "
74234|NCT02595203|"~     The primary objectives of this study are:~        -  To determine the mass balance recovery (expired air, urine and faeces) and route and~          rate of elimination of 14C-Debio 1450.~        -  To determine the metabolic profile of 14C-Debio 1450 in whole blood, plasma, urine and~          faeces.~        -  To determine the pharmacokinetics of total radioactivity and of Debio 1450 (prodrug) and~          Debio 1452 (active moiety) in plasma and urine.~   "
74235|NCT02595190|"~     There are very few data and analysis in the literature regarding the symptomatic sacral~     perineurial cysts. Most studies are case reports or small retrospective sample, which rarely~     more than 20 cases. There is no an consensus on the choice of treatment (medicine~     conservative treatment and surgical treatment) for symptomatic sacral perineurial cysts.Our~     aim, therefore, is to compare the efficacy of medicine conservative treatment and surgical~     treatment for symptomatic sacral perineurial cysts by a randomized controlled trial.~     Meanwhile, resting-state functional magnetic resonance imaging is used to detect the changes~     at pain related brain areas, which will be develop an objective method to evaluate the~     clinical curative effect of the two treatment options.~   "
74236|NCT02595177|"~     To compare refractive outcomes and patient's visual quality after bilateral cataract surgery~     when implanting multifocal intraocular lens, monofocal with monovision or hybrid monovision.~   "
74237|NCT02595164|"~     The role of impulsivity and its contribution to suicidal behavior seems intuitively clear.~     Empirical results have proved the existence of a relationship between the two yet many~     questions are left unanswered, especially what differentiates suicide ideators from~     attempters.. Obsessive thinking patterns are thought processes which share a repetitive~     behavior domain and are exerted by an inner voice. 3 types of obsessive thinking patterns are~     self destructive thoughts, ruminations and overvalued ideas. Impulsivity and obsessive~     thinking patterns are presumed to have a common mechanism of behaviors which are resulted~     from basal ganglia dysregulation and thus effect inhibition. Novel research in the field of~     decision making could help to learn more about behavioral patterns associated with self harm~     behavior and suicide. Eating Disorders involve suicidal and self harm behavior, which both~     feature impulsivity and obsessive thinking patterns. The investigators study proposes a~     3-step theoretical model which asserts there is a connection between impulsivity, obsessive~     thinking and poor decision making, all effecting self harm behavior. Contemporary research~     has not been able to fully understand the nature of impulsivity and its effect on self harm~     behavior, including eating disorders symptoms, nor addressed the impact of obsessive thinking~     patterns on the latter. 100 female participants with Eating Disorders and suicidal behavior~     will be recruited for the proposed research. Subjects will be given self-report~     questionnaires and computerized behavioral tasks. A one way ANOVA of two eating disorder~     subgroups, impulsive and non impulsive, will be conducted, following a hierarchical multiple~     regression with self harm behavior being the dependent variable.~   "
74238|NCT02595151|"~     The morphologic change of microvessels has the clinical value to distinguish cancerous from~     non-cancerous mucosa. The aim of this study was to observe gastric mucosa microcirculatory~     hemodynamic changes real-time using pCLE, compare the differences between chronic nonatrophic~     gastritis and GIM; then evaluate the possible mechanisms associated with gastric mucosal~     blood flow in GIM.~   "
74239|NCT02595138|"~     Triple-negative breast cancer is a special type of breast cancer with poor prgnosis and~     limited choices. Chemotherapy is the only choice of adjuvant systemic treatment options.~     Previous study suggested that zoledronic acid might have anti-tumor effect by eliminating the~     number of DTCs(Disseminated Tumor Cell )and had been proved to be effective as adjvant~     therapy in postmenopausal women whose breast cancer was Homonal receptor positive and who~     were receiving aromatase inhibitors. So it might be able to improve the survival of triple~     negative breast cancer patients.~   "
74254|NCT02594943|"~     Endodrill is a new instrument for biopsy sampling in the GI-channel. The purpose of this~     study is as follows:~        -  Compare the Endodrill instrument with conventional biopsy forceps in terms of ability to~          establish the correct diagnosis of diffuse gastric cancer based on collected biopsies~          from tumor tissue.~   "
74255|NCT02594930|"~     The purpose of this study is to determine whether an undirected synovial biopsy technique has~     the same accuracy in detecting periprosthetic joint infection in the knee as an arthroscopic~     assisted directed synovial biopsy technique.~   "
74240|NCT02595125|"~     Intrauterine devices (IUDs) are contraceptive methods of long-acting (from 3 to 10 years~     depending on the model) and among the most effective. However, there are many obstacles to~     the use of IUDs including pain felt by patients during installation. Several medical means~     were studied without evidence of their efficacy in pain related to IUD insertion. In order to~     remove this brake, it's important to find another way to act against this pain. The direct~     technique is one of the techniques described by health professionals. It seems trusted by its~     users as a more reliable technique but also less painful for patients. However, there is no~     study available on its evaluation. The aim of this study is to investigate the interest of~     the direct technique in reducing the pain experienced by patients during installation.~   "
74241|NCT02595112|"~     Staphylococcus aureus nasal carriage is a major risk factor of infection with this bacterium.~     Staphylococcus aureus colonization of the posterior nasal cavity is still misunderstood. This~     study is aimed at evaluating the relationship between Staphylococcus aureus strains~     colonizing the vestibulum nasi, the sphenoethmoidal recess and the nasopharynx.~   "
74242|NCT02595099|"~     The purpose of this project is to investigate the feasibility and acceptability of a~     Mindfulness based intervention for people who are attending secondary care with~     Osteoarthritis (OA)-related knee pain.~   "
74243|NCT02595086|"~     The aim of this study is to show better postoperative quality of life including lower~     incidence of dumping syndrome and comparable survival after laparoscopic pylorus preserving~     gastrectomy (LPPG), compared to laparoscopic distal gastrectomy (LDG) in patients with~     middle-third early gastric cancer~   "
74244|NCT02595073|"~     Efficacy and Safety of DSXS (Taro Pharmaceuticals, U.S.A., Inc.) in Patients with Moderate to~     Severe Atopic Dermatitis~   "
74245|NCT02595060|"~     This trial evaluates efficacy and safety of inhaled molgramostim (rhGM-CSF) in 45 patients~     with pneumonia associated acute respiratory distress syndrome (ARDS). A third of the patients~     will receive 150 mcg inhaled molgramostim, another third 450 mcg and the remaining third will~     receive inhaled placebo for 3 days. The patients will be followed for 28 days.~   "
74246|NCT02595047|"~     The purpose of this study is to observe the feasibility and its application of autologous~     prefabrication for body surface tissues/oranges~   "
74247|NCT02595034|"~     This study is to evaluate the therapeutic equivalence and safety of Clindamycin and Benzoyl~     Peroxide Gel 1%/5% and BenzaClin® (clindamycin 1%/benzoyl peroxide 5%) Topical Gel~   "
74248|NCT02595021|"~     The purpose of this study is to evaluate the safety and one year disease-free survival of~     total or subtotal colectomy and proctocolectomy in stage IIIc and stage IV epithelial~     ovarian, fallopian tube, and primary peritoneal cancer (EOC, FTC, PPC).~   "
74249|NCT02595008|"~     this study is to evaluate the potential of DSXS to suppress HPA axis function in patients~     with moderate to severe atopic dermatitis.~   "
74250|NCT02594995|"~     Stroke is the first leading cause of death in China, and is responsible for almost 22.4% of~     deaths. In approximately 80% of cases stroke is ischaemic, i.e. caused by disruption of blood~     flow to part of the brain from an acute arterial occlusion. Survival of penumbral tissue~     distal to an arterial occlusion depends on collateral circulation via the Circle of Willis~     and leptomeningeal anastomises. Collateral flow is dynamic and failure is associated with~     infarct growth. The presence of adequate collaterals has been shown to be associated with~     age, history of statin use, and non-hypertension. Dl-3-n-butylphthalide (NBP), isolated from~     the seeds of celery, and found to exert protective effects against ischemic brain and~     increase leptomeningeal blood flow. This study investigate whether NBP injection prescribed~     during acute stroke will have a significant effect to improve collateral circulation in~     patients of anterior circulation occlusion.~   "
74251|NCT02594982|"~     Abstract Background Studies have shown that delirium in medical and surgical intensive care~     units (ICUs) increases mortality, length of stay (LOS) as well as the risk of dementia~     symptoms and cerebral atrophy after discharge. Only few studies have investigated delirium in~     the neurointensive care unit (N-ICU). Delirium is most often assessed by one of two~     instruments: Intensive Care Delirium Screening Checklist (ICDSC) or the Confusion Assessment~     Method for the ICU (CAM-ICU).~      Aims~        1. To measure the effect of a systematic intervention (sedation, sleep, mobilization and~          pain) on delirium symptoms in patients with acute acquired brain injury in N-ICU.~        2. To validate the ICDSC and CAM-ICU to patients with acute acquired brain injury Method~          The design of the study is a two-phase interventional trial. Based on a power~          calculation, 56 patients will be enrolled both in the baseline and the intervention~          group (n=112).~      Part 1: A baseline investigation will be conducted to establish prevalence, duration and type~     of delirium symptoms in patients with acute acquired brain injury before implementing the~     intervention bundle.~      Part 2: A systematic Intervention protocol will be implemented in the N-ICU. The Intervention~     elements consist of a sedation, sleep, mobilization and pain treatment regimen based on the~     newest available evidence.~      Enrolled patients will be contacted 12 months after discharge for a follow-up including a~     quality of life with (EuroQoL-5D) questionnaire, a cognitive test measuring their cognitive~     end point (Repeatable Battery for Assessment of the Neuropsychological Status) and a short~     test for dementia symptoms (MMSE, Mini Mental State Examination).~   "
74252|NCT02594969|"~     The goal is this study is to investigate the effects of dilute bleach on the skin of subjects~     with atopic dermatitis and those with healthy skin. The second goal is to evaluate the~     effects of different moisturizers on the skin barrier of subjects with and without atopic~     dermatitis. The investigators hypothesize that the bleach bath will increase the skin pH,~     decrease the skin hydration, and increase skin water loss in all study subjects. Secondly,~     the investigators hypothesize that moisturizers with the lowest pH and the highest water to~     oil ratio will result in improved skin barrier function. Furthermore, the investigators~     believe there will be a greater improvement in patients with atopic dermatitis.~   "
74253|NCT02594956|"~     The use of nasogastric (NG) decompression after pancreaticoduodenectomy (PD) is a current~     practice. NG tube is associated with a high rate of morbidity including pulmonary morbidity,~     delayed gastric emptying and finally an increased length of hospital stay.~      The absence of NG decompression could be the corner stone of the concept of the enhanced~     recovery program after PD.~   "
87937|NCT02416050|"~     Can brain MRI at entry of cocaine inpatient cessation attempt predict relapse during a three~     month follow-up ? Hypothesis : White matter losses in the prefrontal cortex are associated~     with relapse to cocaine use.~   "
74256|NCT02594917|"~     The investigators are performing this research study to determine whether having low~     iron-sulfur cluster levels can cause a disease known as pulmonary hypertension (PH). PH is~     defined as abnormally high blood pressure in the arteries of the lungs.~      Usually, small specialized structures inside each human cell called mitochondria are in~     charge of generating energy within lung arteries for normal function. During situations of~     disease or stress, lung arteries undergo a change in the function of mitochondria, resulting~     in the development of PH. In studies on mice, investigators have learned that alterations in~     the production of specific metal complexes called iron-sulfur clusters are responsible for~     these changes. This makes it more likely that mice will develop PH.~      In this study, the investigators want to find out if alteration of iron-sulfur cluster~     formation leads to increased likelihood of developing PH in humans.~   "
74257|NCT02594904|"~     Neonatal Glucose-6-phosphate Dehydrogenase(G6PD) Deficiency is one of the significant reason~     for neonatal hyperbilirubinemia and even irreversible bilirubin encephalopathy.The neonates~     may be attacked due to acute infection, eating beans or exposure to oxidative drugs, etc.~      The main clinical manifestations are hemolytic anemia, and the resulting hyperbilirubinemia.~     When bilirubin is pretty high in body, bilirubin may spread into brain, and thus cause~     nervous system damage, and severely affect the prognosis of neonates. Therefore, monitoring~     and early intervention of jaundice has important significance to prevent further aggravation~     of jaundice and certain sequelae. Phototherapy and exchange transfusion are mainly suitable~     methods for severe hyperbilirubinemia, however, patients need to be hospitalized. Yinzhihuang~     Oral Liquid is a kind of traditional Chinese medicine for jaundice. Many large sample and~     multicenter clinical studies show that the positive efficacy of Yinzhihuang Oral Liquid in~     the treatment of neonatal hyperbilirubinemia is exactly confirmed.~      The purpose of this study is try to detect the treatment effect of Yinzhihuang Oral Liquid on~     indirect bilirubin in neonates with G-6-PD enzyme deficiency and neonatal hyperbilirubinemia.~     Try to provide scientific theories for Yinzhihuang Oral Liquid to treat neonates with G-6-PD~     enzyme deficiency and neonatal hyperbilirubinemia.~   "
74258|NCT02594891|"~     Cholangitis is one of the main complications of endoscopic retrograde~     cholangiopancreatography (ERCP). Plastic biliary stent was used to prevent the occurrence of~     post-ERCP cholangitis, but the stent should be taken out 1-2 weeks after ERCP with endoscope~     again. 8.5 F plastic stent with proximal flap can discharge self-driven from biliary to the~     gut, it has the advantage of avoiding pulling stent out with endoscope again. The purpose of~     this study is to explore 8.5 F plastic stent with proximal flap on preventing post-ERCP~     cholangitis of ERCP in patients with choledocholithiasis.~   "
74259|NCT02594878|"~     In a randomized double blind placebo controlled trial to investigate the effect of~     pamidronate in treatment of chronic non bacterial osteomyelitis.~      Main objective:~        1. Reduction of the inflammatory activity in the bone lesions measured by whole body MRI~          after 36 weeks.~        2. Healing of the inflammatory activity in the bone lesions measured by whole body MRI~          after 36 weeks.~      Secondary objectives:~        1. Changes in bone lesions in whole body MRI between baseline and week 12 and between week~          12 and week 36~        2. Changes in bone lesions of anterior chest-wall (adults) evaluated by CT scan between~          baseline and week 36.~        3. Changes in patient self reported outcome measures~        4. Changes in inflammatory markers and bone markers.~   "
74260|NCT02594865|"~     To investigate whether the administration of Glucerna achieves less glycaemic variability,~     defined as the mean absolute glucose (MAG) change, and better glycaemic control compared to a~     standard high-carbohydrate enteral formula. Continuous glucose monitoring technology will be~     used to evaluate glycaemic variability and glycaemic control.~   "
74261|NCT02594852|"~     In this study the investigators want to investigate if the pregnancy rate in conjunction with~     fertility treatment increases with concomitant use of laser therapy.~   "
74262|NCT02594839|"~     The study evaluates the safety and the efficacy of the addition of intravenous~     transplantation of donor bone marrow mesenchymal stem cells in patients with idiopathic~     interstitial pneumonia or connective tissue disease associated with interstitial lung~     disease, which have actively progressing disease with rapid loss of pulmonary function on the~     background of routine treatment.~   "
74263|NCT02594826|"~     This is a randomized trial to evaluate the effects of a community-based intervention on~     increasing cervical cancer screening rates in underserved Korean American women. Due to the~     multiple factors that contribute to screening uptake, an educational program customized to~     Korean culture combined with navigation assistance may be effective in increasing the number~     of Korean American women who can access cervical cancer screening.~   "
74264|NCT02594813|"~     The bleeding rate of both EGD (including biopsy) and colonoscopy (including biopsy or cold~     snare polypectomy) in patients who continue to take various antithrombotic drugs is studied~     prospectively. The immediate or delayed bleeding that requires hemostatic clipping or other~     endoscopic treatments is defined as the bleeding. Immediate bleeding requiring hemostatic~     clipping is defined as spurting or oozing which continued for more than 30 seconds. Delayed~     bleeding is defined as bleeding that requires the endoscopic treatment within 2 weeks after~     endoscopy. Prophylactic clipping is not performed after taking biopsy and doing polypectomy.~     Additionally, investigators evaluate the rate of injured submucosal arteries of the excised~     specimen when the bleeding occurs.~   "
74265|NCT02594800|"~     Atherosclerotic intracranial arterial stenosis (AICAS) corresponds to luminal narrowing of~     the major intracranial arteries. The prevalence of intracranial atherosclerotic stenosis~     accounts for 33% to 67% of stroke or transient ischemic attack (TIA) cases in China and other~     countries in Asia. AICAS is also highly associated with the risk of stroke recurrence.~     Possible mechanisms of cerebral infarction secondary to AICAS are likely linked with~     hemodynamic compromise distal to site of stenosis.~      Computed tomography perfusion (CTP) can be used to evaluate vasoreactivity and~     cerebrovascular reserve in patients with AICAS and predict future stroke. The parameters of~     CTP include ①cerebral blood flow(CBF),② cerebral blood volume(CBV) and ③mean transit~     time(MTT). Relative regional cerebral blood flow (rCBF) was evaluated as the percentage~     radioisotope counts in the region of interest (ROI) of the affected side against the~     corresponding ROI in the unaffected contralateral side.~      Statins can decrease the incidence of transient ischemic attack or ischemic stroke and~     improve stroke outcome. Few studies focus on the relationship between statins therapy and~     cerebral perfusion.~      Whether intensive rosuvastatin therapy compared with standard rosuvastatin therapy can~     improve hemodynamic situation and cerebral perfusion status in AICAS has not been~     illustrated.~      Based on those studies, the investigators hypothesized that intensive rosuvastatin may also~     improve the symptoms of AICAS not only through enhancing the stability of atherosclerotic~     plaques, but also its pleiotropic effects. So it can change the hemodynamic status around the~     plaque and increase cerebral flow in the downstream territory. So in this study the~     investigators try to analysis statin's impact on the hemodynamic changes as well as the~     downstream perfusion which is determined by CTP.~   "
74267|NCT02594774|"~     The objective is to evaluate the efficacy of osteopathic treatment as an adjunct to standard~     medical treatment in reducing child functional abdominal pain.~      A convenience sample that includes no more than 30 patients per study group (n = 60) are~     being recruited. As an exploratory study the investigators did not proceed to make any sample~     size calculation.~      This is a comparative study of two quasi-experimental interventions (standard treatment vs.~     standard treatment + Osteopathy).~      This will be a single-blind trial where only the evaluator will be blinded. The principal~     outcome will be pain measured by a visual analog scale. A version with more appropriate~     pictograms for pediatric patients is used. Measurements will be taken at baseline (baseline~     measurements) at 4, 8 weeks (the duration of interventions) and 6 months post-study.~   "
74268|NCT02594761|"~     The primary objective of this study was to demonstrate pharmacokinetic similarity of Mylan~     trastuzumab (Hercules) versus EU-approved Herceptin® and US-licensed Herceptin® and~     pharmacokinetic similarity of EU-approved Herceptin® versus US-licensed Herceptin® after 8~     mg/kg as single dose administered as intravenous infusion over 90 minutes in healthy male~     subjects based on the equivalence criterion that AUC0-∞, AUC0-last, and Cmax least square~     mean ratios are bounded within the 90% confidence intervals, 80.00% - 125.00%. Three~     similarity assessments were performed, 1) Hercules vs. EU-approved Herceptin®, 2) Hercules~     vs. US-licensed Herceptin® and 3) EU-approved Herceptin® vs. US-licensed Herceptin®.~     Secondary objectives included further pharmacokinetic assessment of similarity of Hercules,~     EU-approved Herceptin® and US-licensed Herceptin® λz, tmax and t1/2 along with assessment of~     safety (including immunogenicity) and local tolerance.~   "
74269|NCT02594748|"~     The aims of the study are as follows:~        -  To improve self-management intention and behavior of patients with type 2 diabetes (T2~          DM).~        -  To promote patients to make plans for their self-management and gradually integrate the~          self-management plan into their daily life.~        -  To improve resilience, well-being, fatigue and quality of life of patients with T2 DM~      In order to achieve the aims, we have set the following objectives:~        -  To develop and apply self-management education program based on the extended theory of~          planned behavior.~        -  To evaluate the efficacy of the educational program:~             1. Self-management education program delivered face to face (intervention group); (b)~               standard usual care (comparison group).~   "
74270|NCT02594735|"~     The purpose of this study is to assess the safety and efficacy of subcutaneous abatacept in~     10 patients seven years of age and older with refractory JDM.~   "
74271|NCT02594722|"~     Chronic Obstructive Pulmonary Disease (COPD) had systemic repercussion and lead to peripheral~     muscular dysfunction. Muscular atrophy limits aerobic capacity and is a major limitation of~     daily activity and quality of life. Technologies likes' neuromuscular electrical stimulation~     (NMES) are currently being adapted and tested to support exercise training.~      The investigators hypothesized that functional electrical stimulation cycling improves VO2~     and aerobic capacities during exercise compared to endurance training.~   "
74272|NCT02594709|"~     Traditional treatment options for optic nerve sheath meningiomas (ONSM) include observation,~     surgery and radiotherapy, but to date none of these has become the clear treatment of choice.~      The role of the radiotherapy remained uncertain because of the concern about radiation~     related optic neuropathy In the recent past two large series of patients treated with a~     fractionated stereotactic radiotherapy confirmed these positive experiences in tumour control~     and greatly reduced the concern about the treatment related toxicity.~      Under the light of successful meningiomas treatment, radiosurgery, had proposed as a~     treatment option. Single session, high conformality, frame based radiosurgery systems are~     seldom if ever proposed as ONSMs treatment due to the known dose tolerance of the optic~     nerve.~      The first experience in ONSMs treatment with multisession radiosurgery treatment was quite~     promising.~      The aim of the present study is to prospectively evaluate the efficacy and safety of~     multisession radiosurgery in ONSMs treatment.~      In order to evaluate multisession radiosurgery 50 patients will be enrolled in the present~     study.~      All patients will be treated by using multisession radiosurgery, with 5 fractions of 5 Gy~     each to a total dose of 25 Gy prescribed to the 75-85% isodose line. Patients were evaluated~     both for tumor growth control and visual function.~   "
74273|NCT02594696|"~     Individuals with severe mental illness (SMI) including schizophrenia and bipolar disorder are~     dying younger than the general population; cancer is a leading cause of death in this~     population. People with SMI have higher rates of dying from breast, lung, and colon cancer,~     and disparities in treatment appear to be one contributing factor. Individuals with SMI may~     be diagnosed with more advanced stage cancer and less likely to receive stage-appropriate~     cancer treatment. Although collaborative care models integrating medical and psychiatric care~     have shown promise in other populations, the challenge of treating SMI and cancer is distinct~     and relatively understudied. Patients may have uncontrolled psychiatric symptoms that can~     impact their understanding of their diagnosis and treatment decisions. Oncologists have less~     training and inadequate time to address multiple unmet needs. Mental health care is~     frequently fragmented from cancer care.~      The investigators want to understand if it is helpful for patients with SMI to be connected~     to a psychiatrist and case manager when cancer is diagnosed. Optimizing psychiatric symptoms~     and facilitating communication between the patient, the oncology team, and mental health~     providers may improve care. The goal is to pilot a pragmatic intervention for patients with~     cancer and SMI that can be integrated into cancer care, is acceptable to patients and~     oncology clinicians, and may promote the delivery of stage-appropriate cancer treatment to an~     underserved population.~      Patients will be connected to a psychiatrist and case manager at cancer diagnosis who will~     follow the patient and communicate with the oncology team during the 12 week intervention.~     All participants will complete brief surveys at baseline, 4 weeks, and 12 weeks. Oncology~     clinicians will provide feedback about the intervention at 12 weeks. Cancer treatment~     received and healthcare utilization will be assessed at 6 months post-intervention.~   "
74274|NCT02594683|"~     A follow-up study of a randomised, controlled, study to investigate the effects of a new~     infant formula given in the first 12 months of life on growth and body composition up to 5~     years of age~   "
74275|NCT02594670|"~     Selecting different acupoints as an combination of acupoints is a key factor to clinical~     efficacy of acupuncture. Different combinations of acupoints will generate different clinical~     efficacy. So,the purpose of this study is to determine the different clinical efficacy among~     three types of combinations of acupoints in the treatment of primary insomnia.~   "
74325|NCT02594020|"~     This study concerns the prevention of dental caries by sealing pits and fissures of permanent~     molars with a photopolymerizable resin. It must compare these three techniques Microdentisty~     (air abrasion, abrasion and sound using small cutters) usually used to prepare micro cavities~     in the enamel and / or the outer third of the dentin. These three commonly used techniques~     have never been compared by retaining as endpoint retention of sealant. These techniques are~     painless and do not require local anesthesia.~   "
74276|NCT02594657|"~     Nowadays, ECC exercise can be realized using various modalities that target small or large~     muscle masses in a segmentary or dynamic way. The training program proposed in this study is~     realised on an handmade ergocycle which allows eccentric contractions.~      With this type of ergometer, O2 consumption (VO2) is three to five fold lower than during an~     exercise realised at the same power output with a concentric ergocycle. Due to this later~     propertie, which origins are not yet fully identified, there is an increasing interest to~     embed ECC in rehabilitation programs.~      The investigators hypothesis that a higher pedal rate will induce a lower oxygen consumption,~     with the same benefits.~      This study aims to compare oxygen consumption at two pedal rates : 50 and 80 rotation per~     minute (rpm).~      The ultimate goal is to assess efficacy and tolerance of eccentric training on ergocycle and~     to enhance comprehension of the physiological mecanisms involved in the lower O2 consumption~     observed.~   "
74277|NCT02594644|"~     The aim of this study is to investigate how varying incubation periods of topical~     aminolevulinic acid after pretreatment with microneedle application can facilitate the~     penetration and efficacy of photodynamic therapy.~   "
74278|NCT02594631|"~     The aim of the study is to compare the safety and efficacy of ESWL and visual~     cystolitholapaxy in management of calcular acute urine retention.~   "
74279|NCT02594618|"~     The aim of this study is to assess energy regulation of overfeeding and performing common~     household activities in young Chinese males using whole-body room calorimetry up to 10 hours.~   "
74280|NCT02594605|"~     Platelet rich fibrin is a second generation platelet concentration which contains various~     growth factors. The aim of this study is to evaluate the clinical and biochemical efficacy of~     PRF in subjects of chronic periodontitis in the operation of conventional periodontal flap.~   "
74281|NCT02594592|"~     This cross-sectional study aimed to validate the effectiveness of the combined use of the~     Osteoporosis Self-Assessment Tool for Asians (OSTA) and the One-Minute Osteoporosis Risk Test~     (IOF test) in a population from Wuhan, China.~   "
74282|NCT02594579|"~     A randomized double blind placebo control trial study will be conducted in critically ill~     patients with vitamin D deficiency. Investigator aimed to study the effect of oral vitamin D3~     supplementation, compare to placebo, on skeletal muscle mass and body composition.~   "
74283|NCT02594566|"~     If the participant decides to take part in the study, the participant will need to do the~     following:~      Visit the study clinic up to 10 times and be available for a reasonable amount of follow up~     phone calls to see how the participant is doing.~      The participant will receive three doses of vaccine injected into the muscle of the upper~     arm. After each injection the participant will be asked to remain at the study site for at~     least 30 minutes after the participant receives the study vaccine.~      The results of all of the participants blood tests, just like all other laboratory test~     results, will be provided to the Investigators, Sponsor, and vaccine developer. Positive HIV~     and viral hepatitis test results will be reportable to local health authorities according to~     local laws.~      The participant will be asked to refrain from excessive physical activities and alcohol~     consumption within 2 days before each clinic visit to avoid possible confusing effects on~     laboratory tests.~   "
74284|NCT02594553|"~     The CHILI cluster randomised controlled trial (RCT) will investigate whether the use of an~     interactive information booklet during consultations for febrile children at General Practice~     (GP) out-of-hours centres can reduce the number of antibiotic prescriptions, improve parental~     satisfaction and reduce intention to reconsult for childhood fever episodes.~   "
74285|NCT02594540|"~     The purpose of this study is to evaluate safety and effectiveness of the peripheral~     mechanical stimulation of the feet on gait variables, clinical status, risk of falls, BDNF~     levels, immunological profile and brain functional connectivity changes in patients with~     Parkinson's disease.~   "
74286|NCT02594527|"~     Physical activity levels of hospitalised older inpatients is low and this results in many~     adverse health outcomes. Studies have shown that interventions designed to promote increased~     physical activity of older inpatients using paid staff have shown improvement in physical~     function of older inpatients, resulting in shorter hospital stay and reduced admissions to~     nursing home. This study aims to assess the feasibility and acceptability of using trained~     volunteers to increase physical activity of older people in hospital. Volunteers will be~     recruited and trained to encourage older inpatients to mobilise or perform chair-based~     exercises. Patients will be encouraged to walk or exercise with the volunteers twice a day~     during their hospital stay. Quantitative analysis will be conducted on the outcome measures.~     Patients, volunteers and staff members will also be interviewed to assess the acceptability~     of the intervention. This feasibility study will help inform a future controlled trial.~   "
74287|NCT02594514|"~     Severe obesity (SO), defined as BMI≥95th percentile, has increased worldwide among~     adolescents. American studies estimated that 1.3-2.8% of 12-19-year-old individuals have a~     BMI >40 kg/m2 or a BMI >35 kg/m2 with at least one serious co-morbidity. The immediate and~     long-term risks associated with SO in adolescents include cardiovascular and metabolic~     diseases, obstructive sleep apnoea and nonalcoholic fatty liver disease. However, the results~     of sleeve gastrectomy in adolescents are still uncertain.~      Objective and hypotheses: Investigators aimed to assess the long-term safety, efficacy, and~     cardiovascular risk changes of laparoscopic sleeve gastrectomy in adolescents with SO.~      Method: Longitudinal retrospective study of 22 adolescents with SO who underwent laparoscopic~     sleeve gastrectomy. Clinical and metabolic variables immediately before surgery and after 6,~     12, 18 and 24 months were assessed.~   "
74288|NCT02594501|"~     The purpose of this study is to determine whether patients undergoing coronary intervention~     that also require oral anticoagulation, treatment with the COBRA PzF stent plus 14-day dual~     anti-platelet therapy (DAPT) has higher safety and non-inferior outcomes for thrombo-embolic~     events than compared with standard FDA-approved drug eluting stent (DES) plus 3 or 6-month~     DAPT.~   "
74289|NCT02594488|"~     The majority of deaths after myocardial infarction occurs in patients with preserved left~     ventricular ejection fraction (>35%) for whom no prophylactic strategies exist. Periodic~     Repolarization Dynamics (PRD) and Deceleration Capacity (DC) of heart rate are autonomic risk~     markers that identify a new high risk group of patients with LVEF 35-50% who have the same~     poor prognosis as patients with LVEF ≤35%.~      In SMART-MI, post-infarction patients with LVEF 35-50% and abnormal PRD and/or DC will be~     randomly assigned to biomonitoring-guided therapy or conventional follow-up.~   "
74290|NCT02594475|"~     Endoscopic retrograde cholangiopancreatography (ERCP) has been widely used in diagnosis and~     treatment of pancreaticobiliary diseases. Traditionally, ERCP has been performed in the prone~     position. The prone position for ERCP can facilitate selective bile duct cannulation, offer a~     better fluoroscopic image of pancreaticobiliary anatomy, and prevent aspiration of gastric~     contents. However, in cases of difficult in the prone position, ERCP has been performed in~     the left lateral or supine position. Compared with the prone position, left lateral position~     is more comfortable for patients, especially with limitation for cervical movement including~     cervical cord injury, cervical spine operation, parkinson's disease, contracture due to~     cerebral infarction, and allow more easy passage of the scope through the pharynx, and useful~     to secure airway. However, in the left lateral position, it is difficult to obtain~     fluoroscopic image of right hepatic duct and intrahepatic bile duct.~      In cases of severe abdominal pain, severe abdominal distension, large amount of ascites,~     recent abdominal surgery or cervical spine surgery, intra-abdominal catheter insertion,~     severe obesity, it is difficult to position in prone or left lateral, therefore, ERCP may be~     performed in the supine position. In supine position for ERCP, there has been documented~     increased risk of cardiopulmonary adverse event and decreased success rate of selective bile~     duct cannulation.~      There have been reported the efficacy and safety between the prone position and supine~     position for ERCP in several studies. We aimed to evaluate the efficacy and safety between~     the prone position and left lateral position for ERCP in this prospective, randomized study.~   "
74291|NCT02594462|"~     Sickle cell anemia is a homozygous genetic disease with high prevalence in Brazil. There are~     changes in conformation and physicochemical properties of red cells that generate varied~     clinical manifestations among which is chronic hemolytic anemia, cardiovascular diseases,~     fever, splenic sequestration and usually painful crises. Women with sickle cell anemia have~     high maternal-fetal and neonatal morbidity and mortality. During pregnancy, there is~     intensification of maternal anemia, episodes of painful crises; and also, more obstetric~     risks, such as pre-eclampsia, thromboembolism and hemorrhage. Thus, there is the need for~     adequate reproductive family planning for this population conducted mainly through hormonal~     contraception. The World Health Organization recommends that all contraceptive methods may be~     prescribed for people with sickle cell anemia women, being the progestogen-only contraceptive~     methods the most indicated due to no changes in venous or arterial thrombosis. Nevertheless,~     there is need for further scientific evidence as the best contraceptive choice among women~     with sickle cell anemia in relation to safety, adhesion and reduction of pain crises. The~     objective of this study is to evaluate the clinical effect through safety of~     etonogestrel-releasing contraceptive implant in women with sickle cell anemia during twelve~     months.~   "
74292|NCT02594449|"~     To compare pharmacodynamics among the different concentrations of BCS and NS.~   "
74293|NCT02594436|"~     This is a prospective, non-interventional study of adult patients prescribed topical~     treatment with ingenol mebutate gel (Picato®) as part of provision of care for the treatment~     of Non-hyperkeratotic, non-hypertrophic Actinic Keratosis (AK). Patients with complete~     clearance at 8 weeks will be followed for one year or until retreatment of AK in the area~     initially treated, whatever comes first. For patients with incomplete clearance in the~     treated area at 8 weeks the treatment strategy for this area will be recorded but no further~     follow-up will take place. The effectiveness, tolerability, adherence, patient satisfaction~     and health-related quality of life (HRQoL) associated with Picato® treatment will be~     evaluated.~   "
74294|NCT02594423|"~     The cornea is the transparent window of the eye, which allows light to enter into the eye and~     also contributes to the focusing of the light rays. One of the major factors responsible for~     its transparency is the lack of blood vessels. However, following inflammation new blood~     vessels (corneal vascularisation [CVas]) grow into the cornea affecting its transparency and~     impairing vision. CVas leads to further damage in the form of scarring,oedema,fat deposition~     and is a major cause of corneal graft rejection.~      In 2000 with ethical approval (OY129801) the investigators developed and published a clinical~     technique called Fine Needle Diathermy occlusion of corneal vessels (FND). This has proven~     very successful for occluding established vessels and is practiced in many centers across the~     world. Recently it has been demonstrated that by inhibiting a chemical stimulant of vessel~     formation called vascular endothelial growth factor(VEGF) active new vessel growth in the~     retina can be suppressed. The approach is also being used for corneal new vessels.~     Bevacizumab (Avastin) is a chemical inhibitor of VEGF and is used extensively to treat~     retinal new vessels in macular degeneration. Avastin has been shown to be effective and safe~     in treating corneal new vessels. The investigators propose to evaluate the efficacy and~     safety of FND alone and FND combined with Avastin in treatment of CVas.~   "
74295|NCT02594410|"~     To evaluate the efficacy of renal artery stent combined with standardized medical therapy as~     treatment for renal artery stenosis.~   "
74296|NCT02594397|"~     The purpose of this study is to determine whether the different combination of acupoints have~     different effect on diabetic gastroparalysis.~   "
74297|NCT02594384|"~     This is a Phase 1 dose-exploration study of LAM-002A administered by mouth in patients with~     relapsed or refractory B-cell NHL. Safety, tolerability, pharmacokinetics (PK),~     pharmacodynamics (PD),and preliminary anti-tumor activity will be evaluated.~   "
74298|NCT02594371|"~     To determine the safety and tolerability of Oraxol as compared to IV paclitaxel in metastatic~     breast cancer~   "
74299|NCT02594358|"~     Prospective data on the visual acuity response in children treated by patching concurrently~     treated with caffeine and estimate the magnitude of effect that might be seen in a randomized~     trial (if no improvement in acuity is seen, this would be sufficient evidence to decide not~     to conduct a randomized, double blind trial).~      Collect prospective data on the tolerability of caffeine in two dosages as an adjuvant~     treatment for amblyopia and provide limited data on its safety.~      Evaluate the potential for a dietary intervention to enhance the acceptance and tolerability~     of patching on the child and family.~      Demonstrate recruitment potential of subjects to participate in a dietary intervention study.~   "
74300|NCT02594345|"~     This study is designed to analyze the effect exosomes derived from red blood cell units have~     on blood coagulation and platelet function. It is an in vitro study using healthy volunteers'~     blood.~   "
74301|NCT02594332|"~     The purpose of the MEMORY trial is to compare the effects of mepolizumab with Placebo on~     airway physiology in patients with eosinophilic asthma~   "
74302|NCT02594319|"~     This research seeks to examine psychological factors that may impact relationship between~     incentives and health behavior engagement, specifically fruit and vegetable consumption.~     Additionally, it will compare the impact of two different incentive schedules on behavior~     engagement, one providing immediate rewards (i.e. rewards received on a daily basis) and~     another providing delayed rewards (i.e. rewards received at the end of the study period),~     with a control condition in which no rewards are offered. Study participants will provide~     reports of their fruit and vegetable consumption each day for three weeks, and in the two~     incentive conditions, they will receive small monetary rewards for their fruit and vegetable~     consumption. Following the three week reporting and reward period, participants will complete~     two additional assessments, measuring psychological constructs and behavior engagement~     following the cessation of rewards.~   "
74303|NCT02594306|"~     Drug addiction is compulsive and spontaneous drug-taking behavior which is characterized by~     non-medical usage, long and repeated exposure to addictive drugs and gradually increasing~     drug-taking dosage and frequency,and become a main threat against human being's public~     health, economic development and social safety.~   "
74304|NCT02594293|"~     This study evaluates whether Peg-IFN alfa-2a can reduce the recurrence rate of hepatitis B in~     96 weeks after nucleoside analogue (NUC) withdrawal.~      The HBV HBeAg-Negative patients who received NUC anti-virus treatment for 2.5 years and~     reached stopping rule in 《Chinese chronic hepatitis B prevention and treatment~     guidelines》(2010) were randomly assigned into three groups: One group discontinue the NUC~     treatment and follow up for 96 weeks,One discontinue the NUC treatment ,receive Peg-IFN~     alfa-2a 180 μg by week for 24 weeks and follow up for 72 weeks,The other discontinue the NUC~     treatment ,receive Peg-IFN alfa-2a 180 μg by week for 48 weeks and follow up for 48 weeks.~   "
74305|NCT02594280|"~     Establish electrophysiological benchmarks, using the Diopsys Visual Evoked Potential/ Pattern~     ERG (VEP/PERG) protocols of populations with Glaucoma following: 1) Baseline VEP/ERG prior to~     treatment; and 2) VEP/PERG after treatment.~   "
74306|NCT02594267|"~     The purpose of this study is to evaluate the Maximum Tolerated Dose (MTD) of pralatrexate in~     combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) regimen in~     patients with newly diagnosed peripheral T-cell lymphoma (PTCL).~   "
74307|NCT02594254|"~     The purpose of this study is to evaluate if C16G2 Gel administered over a certain period of~     time either with a toothbrush or a custom dental tray can effectively kill bacteria in the~     mouth that cause dental cavities.~   "
74308|NCT02594241|"~     Patients who undergo abdominal wall reconstruction for giant ventral hernia repair will be~     randomized to either methylprednisolone or saline preoperatively, to examine the effects of~     methylprednisolone on postoperative pain, nausea and recovery after giant ventral hernia~     repair.~   "
74309|NCT02594228|"~     A primary aim of the current proposal is to compare the effect of daily consumption of~     healthy lean protein as either whey protein (2 meals per day) or whole food (25% of total~     daily caloric intake) consumed as 6 small meals throughout the day, one of which is consumed~     immediately following exercise training (within 30 min) and another 2 hours prior to going to~     bed at night, over a 16 week period on muscle and fat mass, cardiovascular health, aerobic~     fitness, glucose, insulin, blood lipids, heart rate and muscle strength in overweight men and~     women.~   "
74310|NCT02594215|"~     Background:~      Proteus syndrome (PS) is caused by a mutation in the AKT1 gene. This gene makes a protein~     that communicates with other proteins in the body to make cells grow. The AKT1 mutation~     changes chemical signals in the body and causes overgrowth. PS can be fatal. The drug ARQ 092~     reduces signals from the AKT1 protein. This may reduce or stabilize some of the overgrowth in~     people with PS. Researchers want to find the best dose of ARQ 092 based on its effect on~     tissues in people with PS.~      Objective:~      To determine the safety, tolerability, and recommended dose of ARQ 092 in people with PS.~      Eligibility:~      People ages 6 and older with PS~      Design:~      Participants will be screened with medical history, physical exam, and blood and urine tests.~      Participants will take ARQ 092 by mouth once daily for up to 12 28-day cycles.~      Participants must stay near the NIH Clinical Center (CC) during the whole first cycle, for~     weekly visits to the CC. For cycle 2, they will have visits every 2 weeks. They will have 1~     visit before cycles 3 and 4, and once before every other cycle for cycles 5 11. The final~     visit will be at the end of cycle 12. Visits may include:~      Small skin samples taken.~      ECG: Soft electrodes on the skin record heart signals.~      Echocardiogram: A small probe held to the chest takes pictures of the heart.~      MRI: Participants will lie in a machine that takes pictures of the body.~      Joint and mobility function tests.~      Participants will complete surveys by phone and in person.~      Participants will keep a daily medication and symptom diary.~   "
74311|NCT02594202|"~     Background:~      Prostate cancer is the most common noncutaneous cancer among men in the U.S. Researchers want~     to study blood, tissue, and fluid samples of people with prostate cancer. This will help them~     understand any changes in cells and genes. These changes might lead to the development and~     progression of prostate cancer. Researchers think the study could lead to new treatments.~      Objective:~      To understand the changes in cells and genes that lead to the development and progression of~     prostate cancer. This could lead to new treatments.~      Eligibility:~      Men ages 18 and older who have or are suspected to have prostate cancer~      Design:~      Participants will be screened with physical exam and medical history.~      Participants will send tissue blocks of their tumor, if possible. If not, they will provide~     unstained slides of tumor tissue.~      Participants may provide samples of blood, urine, saliva, and prostate secretions.~      Participants may have imaging tests. They will lie in a machine that takes pictures of their~     body. These tests include:~      MRI of the prostate~      CT of the abdomen and pelvis~      Chest x-ray~      Participants may need a biopsy or surgery for treatment of their cancer. If so, researchers~     will collect tissue.~      Participants may answer questions about their prostate cancer and quality of life.~      Participants may have follow-up visits or other treatments. They may have follow-up phone~     calls every few months.~   "
74381|NCT02593292|"~     This French multicentre open-label randomized trial will test the hypothesis that a~     coordinated health circuit based on obstetric risks, backed up by an electronic patient care~     reporting information system will optimize the continuum of pregnancy care monitoring. The~     electronic patient care reporting information system will be shared between patients, private~     practice physicians/midwifes, hospital physicians/midwifes and supervised by a coordinating~     midwife.~   "
74312|NCT02594189|"~     Background:~      Influenza A H3N2 is a flu virus. Symptoms include fever, cough, and runny nose. It can also~     be more serious. Researchers want to know more about how influenza causes disease in people.~     They hope to develop new vaccines and treatments for flu infection.~      Objective:~      To find the smallest amount of Influenza A H3N2 virus that causes a mild to moderate flu~     infection in healthy people. Also, to study the body s immune response to this virus and how~     the infection develops.~      Eligibility:~      Healthy people ages 18 50 who are:~      Non-smokers or non-habitual smokers~      Willing to not smoke for at least 9 days~      Design:~      Participants will be screened under NIAID protocol #11-I-0183~      Participants will stay at an isolation unit at the clinic for at least 9 days. They will~     remain in the isolation unit except for study-specific activities.~      The influenza virus will be sprayed into the nose.~      Participants will be monitored 24 hours a day. They will have tests, including:~      Medical history~      Physical exam~      Daily questionnaires about symptoms~      Blood and urine tests~      Nasal wash and swab: A small tube of salt water is placed in the nose to wash it. It then~     collects the~      fluid. Or the inside of the nose is rubbed with a swab.~      ECG: Measures the heart s electrical signals~      ECHO: Sound waves take pictures of the heart~      PFTs/Spirometry: They will blow into a machine that measures the air they blow.~      Participants will be discharged after they test negative for influenza A.~      Participants will return to the clinic for 4 follow-up visits over 8 weeks. They may complete~     questionnaires at home.~   "
74313|NCT02594176|"~     Primary Objective To substantiate the efficacy of 2.2 g FLEXISEQ® for the treatment of pain~     related to osteoarthritis (OA) of the knee in patients contraindicated for or with clinical~     intolerance to NSAIDs.~      Secondary Objectives~        -  To substantiate the efficacy of 2.2 g FLEXISEQ® for the treatment of stiffness and~          improvement of joint function in patients contraindicated for or with clinical~          intolerance to NSAIDs and with OA of the knee.~        -  To substantiate safety and tolerability of 2.2 g FLEXISEQ® in patients contraindicated~          for or with clinical intolerance to NSAIDs and with OA of the knee.~   "
74314|NCT02594163|"~     This is a randomized, open-label, multicenter, Phase 2 clinical trial designed to evaluate~     the efficacy and safety of brentuximab vedotin in combination with rituximab and bendamustine~     for the treatment of patients with relapsed or refractory CD30-positive diffuse large B-cell~     lymphoma (DLBCL) after failure of second-line salvage therapy or as second-line treatment in~     patients ineligible for autologous stem cell transplant (ASCT).~   "
74315|NCT02594150|"~     A four arm randomized pilot study to assess if the rate of completion of Fecal Immunochemical~     Test is increased by the addition of financial incentives.~   "
74316|NCT02594137|"~     The purpose of this study is to compare two surgical techniques for a neurosurgical procedure~     used to treat cerebral edema (decompressive craniectomy): with watertight duraplasty vs.~     without watertight duraplasty (rapid closure decompressive craniectomy).~   "
74317|NCT02594124|"~     The primary objective is to evaluate the long-term safety and tolerability of nusinersen~     (ISIS 396443) administered by intrathecal (IT) injection to participants with Spinal Muscular~     Atrophy (SMA) who previously participated in investigational studies of nusinersen. The~     secondary objective is to examine the long-term efficacy of nusinersen administered by IT~     injection to participants with SMA who previously participated in investigational studies of~     nusinersen.~   "
74318|NCT02594111|"~     Inflammation in the arteries of the heart may increase the risk of cardiac death. The~     proposed research seeks to identify the potential beneficial role of a safe anti-inflammatory~     medication, colchicine, on reducing damage caused by opening up a blockage in the arteries of~     the heart. With its quick onset of action and excellent safety profile, colchicine may have~     the potential to reduce risk of major adverse events related to the heart. This research also~     seeks to better understand the role of neutrophils, the most common type of inflammatory~     white blood cell in the body, when there is damage to the heart.~   "
74319|NCT02594098|"~     Atopic Dermatitis, also known as atopic eczema, or eczema, is a common skin disease that can~     affect males and females of all ages, but often starts in childhood. Recent studies show at~     least 4-7% of adults and 15-25% of children to be affected, with one third of patients having~     severe disease. It results in very itchy, red, swollen, and cracked skin. Scratching worsens~     the symptoms and causes the skin to become thickened over time. Patients with atopic~     dermatitis have an increased risk of skin infections, and many also develop hay fever or~     asthma. Atopic dermatitis can cause significant distress to both patients and their families.~      In this study, the aim is to assess the effects of a new treatment called secukinumab in~     patients with atopic dermatitis. A total of 30 patients will be included in the study, which~     will run for a total of 52 weeks.~   "
74320|NCT02594085|"~     The objective is to investigate the impact that faecal output has on adhesives.~   "
74321|NCT02594072|"~     Two radiation therapy techniques are commonly used for the treatment of intermediate and high~     risk prostate cancer: brachytherapy and external beam radiation therapy (EBRT). However, both~     have limitations. Brachytherapy, in which radioactive seeds are inserted into the prostate,~     produces excellent outcomes but is invasive and not all patients are eligible or willing to~     receive this treatment. EBRT, while gentle at the time of delivery, tends to be very~     prolonged and may have poorer outcomes than brachytherapy. This study will examine the use of~     stereotactic ablative radiotherapy (SABR), in which patients are given only a few, high dose~     radiation treatments. Treatments are short, non-invasive, applicable to patients not able to~     do brachytherapy, and may be more effective than conventional EBRT. This study will compare~     SABR with EBRT in terms of the rates of acute and late toxicities for each treatment,~     disease-free survival, and health-related quality of life measures.~   "
74322|NCT02594059|"~     The aim of the study is to assess the peripheral endothelial function in adult patients with~     idiopathic pulmonary fibrosis (IPF) and the relationship between the peripheral endothelial~     function and the severity of the IPF.~   "
74323|NCT02594046|"~     This randomized, placebo-controlled, double-blind study evaluates the efficacy and~     tolerability of the allogeneic human adipose derived stem cell component extract on~     androgenic alopecia in relatively healthy adults. A total of 38 subjects received 1.2 g of~     allogeneic human adipose derived stem cell component extract per month or a placebo for 16~     weeks.~   "
74324|NCT02594033|"~     This trial is conducted in Europe. The aim of the trial is to investigate different needle~     features assessed by comparing insulin aspart Pharmacokinetics profiles (the exposure of the~     trial drug in the body)~   "
74326|NCT02594007|"~     Heart Failure (HF) affects 5.7 million Americans and is the only major cardiovascular~     disorder on the rise. The primary aim of this study is to formally study the combined effects~     of several different tele-health modalities, all currently approved and available for general~     use, to determine if such combinations will result in an increase in early intervention and a~     resultant decrease in acute cardiac decompensation requiring a hospitalization or Emergency~     Room (ER) visit. This study will attempt to characterize the frequency of health care~     interventions attributable to the use of these technologies, and any relationship between~     these interventions and the frequency of hospitalization or ER visits.~      Secondary objectives include characterization of healthcare utilization, healthcare costs,~     and patient experiences with regard to the use the provided technologies.~   "
74327|NCT02593994|"~     The purpose of this study is to evaluate the relative effectiveness and safety of Onyx stent~     compared to other (drug eluting stents) DES.~   "
74328|NCT02593981|"~     As many as 57% of older adults complain of major disruption of sleep, 29% struggle to fall~     asleep and 19% complain of early-morning awakening. The implications of this sleep~     deprivation are sobering, particularly among older individuals.~      The primary goal of this study is to determine whether a palatable foodstuff which contains a~     fruit/honey drink and which is taken every evening before bedtime leads to improved sleep in~     community-living individuals with sleep problems.~   "
74329|NCT02593968|"~     The purpose of this study is to evaluate the efficacy of Yallaferon in Chinese population~     with HPV-16 and/or HPV-18.~   "
74330|NCT02593955|"~     The purpose of this randomized, controlled interventional study is to determine the effects~     of a high intensity exercise training program on objective sleep measures, daytime~     sleepiness, mobility, and brain health/functional connectivity in patients with Parkinson's~     disease.~   "
74331|NCT02593942|"~     Total intravenous anaesthesia using propofol and remifentanil are routinely used drugs for~     this purpose. The hemodynamic stability and at the same time early emergency are the main~     goals following neurosurgery. However there is no standard for discontinuation time for~     manually controlled systems today.~      The investigators aimed to study the effect of remifentanil infusion alone for early~     emergence and hemodynamic stability during the closure period in patients undergoing~     supratentorial craniotomy.~   "
74332|NCT02593929|"~     This study will identify baseline and/or pharmacodynamic biomarkers of response to~     ruxolitinib, based upon association with quantitative change in tumor size following 14-21~     days of neoadjuvant ruxolitinib in patients with operable HNSCC.~   "
74333|NCT02593916|"~     To create a registry/database of patients who either have taken drugs that treat~     cardiovascular conditions or that have presented with cardiovascular symptoms that may be~     related to medication.~   "
74334|NCT02593903|"~     The purpose of this study is to evaluate the efficacy of prophylactic antibiotics following~     distal or mid-shaft hypospadias repair in influencing the rate of postoperative urinary tract~     infection and complications.~   "
74335|NCT02593890|"~     A randomised interventional comparative control study will be undertaken to compare the THEYA~     Recovery Range postoperatively for patients undergoing wider lumpectomies, partial~     mastectomies and total mastectomies to current practice using a mixed method combining~     quantitative and qualitative instruments. 100 female participants are hoped to be recruited~     following breast surgery after a newly diagnosed breast cancer.~      This study will answer the research question:- What is the clinical and psychosocial impact~     of the THEYA Recovery Range in comparison to recommended practice during and after breast~     cancer treatment? This study will leverage the findings of a pilot study conducted by~     Applied Research Connected Healthcare (ARCH) measuring the usability of the THEYA Recovery~     Range.~      This study aims to assess the participants' experience of recovery in the immediate~     post-operative period and the psychosocial effect of THEYA Recovery Range in comparison to~     current recommended practice.~   "
74336|NCT02593877|"~     This trial compares the haemostatic effect of viscoelastic haemostatic assay (VHA)-guided~     transfusion strategy versus non-VHA guided transfusion strategy in haemorrhaging trauma~     patients. Half of the randomised patients will receive VHA-led management of bleeding, whilst~     the other half will receive massive transfusion protocol resuscitation using conventional~     coagulation tests.~   "
74337|NCT02593864|"~     Veterans have much higher risk of osteoarthritis (OA) then the general population. Knee OA is~     common among Veterans and is a leading cause of disability. The earliest stages of OA~     development, where the joint cartilage wears away, is usually painless. By the time Veterans~     experience symptoms, the OA is typically advanced and there is nothing that can be done~     except palliation until the joint is replaced with metal and plastic. If there was a blood~     test to provide early warning of cartilage wear and joint deterioration, Veterans could~     potentially be treated early enough to slow down or even prevent OA. So far, development of~     such a blood test has proved elusive. The investigators propose a new method to amplify the~     signs of cartilage wear in the blood by challenging the affected joint with a walking task.~     Similar to a cardiac stress test, this walking challenge may help to separate joints at risk~     from healthy joints. The investigators will also see if this 'OA stress test' can show if a~     simple and inexpensive load-modifying shoe can improve joint health in Veterans with early~     knee OA.~   "
74338|NCT02593851|"~     The purpose of this study is to evaluate pharmacokinetics, safety, tolerability, antiviral~     activity, and impact on the clinical course of Respiratory Syncytial Virus (RSV) infection~     after multiple oral doses of JNJ-53718678 at different doses and/or dosing regimens in~     infants (greater than [>] 1 month to less than or equal to [<=] 24 months of age) who are~     hospitalized with RSV infection.~   "
74339|NCT02593838|"~     This study aims at evaluating the feasibility of CT myocardial perfusion imaging in daily~     clinical practice and compare it to SPECT perfusion imaging in order to assess sensitivity~     and specifity of CT myocardial perfusion imaging compared to SPECT.~   "
74382|NCT02593279|"~     The aim of the study is to describe asthma phenotype with small airways dysfunction, in a~     multiparametric manner, with clinical, biological, morphological and genetic elements~     compared with asthma with proximal airways obstruction.~      The objective of this study is also to complete the clinical, immunobiological and~     morphological analysis of asthma with small airways dysfunction.~   "
74340|NCT02593825|"~     The purpose of this project is to evaluate the efficacy of Sitting Together And Reaching To~     Play (START-Play), an intervention designed to target sitting, reaching, and motor-based~     problem solving to improve development and readiness to learn in infants with motor delays or~     dysfunction. There is limited research examining the efficacy of early physical intervention~     on infants with neuromotor dysfunction. In addition, most early motor interventions have not~     been directly linked to learning, despite the research demonstrating an association between~     motor activity and cognitive skills. START-Play specifically targets motor skills that lead~     to greater physical exploration, which has been associated with improved problem solving and~     global development. A randomized controlled trial of START-Play will be conducted across four~     states to investigate the impact of the intervention on changes over time in sitting and~     reaching, subsequent changes in global cognitive development, and the mediating influences of~     motor skill changes and problem solving. The research team will conduct a randomized~     controlled trial to evaluate the impact of START-Play on motor development, motor problem~     solving, global development including cognitive problem solving of infants with neuromotor~     delay and dysfunction. Infants will experience either the intervention or services as usual~     for 3 months, with following testing at three time points up until 9 months post~     intervention. The researchers will determine whether the intervention leads to improved~     sitting and reaching, which leads to improved motor-based problem solving, which leads to~     improved global development and problem solving.~   "
74341|NCT02593812|"~     The study determines whether standard medical care (dopamine) affects learning and retention~     of a postural stepping task in people with Parkinson's disease (PD) and whether training on a~     postural stepping task generalises to performance on an untrained postural task. Half the~     participants will train on the stepping task after they have taken their first dose of~     dopamine for the day (i.e. on medication state) while the other half will train on the same~     stepping task before taking their first daily dose of dopamine (i.e. off medication state).~   "
74342|NCT02593799|"~     Esophageal variceal bleeding is one of the most lethal complications of liver cirrhosis. In~     the early stage of liver cirrhosis, the prediction of esophageal varices is very important~     for guiding the clinical decision making of primary prophylaxis of variceal bleeding.~   "
74343|NCT02593786|"~     The purpose of this study is to determine whether nivolumab is safe and effective in the~     treatment of advanced or recurrent solid tumors in Chinese subjects.~   "
74344|NCT02593773|"~     The purpose of this phase 3 multi-center, open-label extension study is to evaluate the~     long-term safety of ACTIMMUNE® (interferon-γ 1b) in participants with Friedreich's Ataxia.~   "
74345|NCT02593760|"~     This multicenter, randomized, double-blind, placebo-controlled study will evaluate the~     efficacy and safety of vismodegib plus (+) ruxolitinib versus placebo + ruxolitinib in~     participants with intermediate- or high-risk MF. The study will be divided into 2 components.~     The Phase Ib portion of the study consists of participants receiving open-label vismodegib~     (150 milligrams [mg] orally [PO] once daily [QD]) + ruxolitinib (PO twice daily [BID]). A~     safety assessment will be performed after the first 10 participants have been treated for 6~     weeks. An analysis for efficacy and safety is planned in the first 10 participants at Week~     24. There will be a hold on participant screening and enrollment during this assessment.~     Another 10 participants may be enrolled, thereafter, to further assess efficacy and safety~     (at Week 24) before the initiation of the Phase III randomization portion of the study.~     Similarly, there will be another hold on participant screening and enrollment during this~     assessment. The participants enrolled in the Phase Ib portion of the study will continue to~     receive vismodegib (150 mg PO QD) + ruxolitinib (PO BID) for up to 48 weeks, if clinical~     benefit is observed after 24 weeks. The Phase III randomized, double-blind portion of the~     study will enroll approximately 84 participants. Participants will be randomly assigned in a~     1:1 ratio (double blind) to receive either vismodegib (150 mg PO QD) + ruxolitinib (PO BID)~     or placebo (PO QD) + ruxolitinib (PO BID) for up to 48 weeks.~   "
74346|NCT02593747|"~     To assess the bioequivalence of Loratadine Oral Solution/Syrup 1mg/mL (GPLA Formula) versus~     Claritin Peach Syrup 1mg/mL (ANNA Formula)~   "
74347|NCT02593734|"~     The purpose of this study is to evaluate a bundled intervention of psychotropic drugs and~     daily contact with a nurse for people with mental health disorders in a prayer camp and~     secondly to assess whether the attitudes of the prayer camp staff toward mental health~     disorders and conventional medicines remain the same after the intervention.~   "
74348|NCT02593721|"~     The purpose of this study is to compare the effectivity of Median Nerve Neural Mobilization~     and oral Ibuprofen in treating patients who suffer cervicobrachial pain~   "
74349|NCT02593708|"~     Open label, non-randomized, dose escalation and expansion Phase Ia/b trial to evaluate the~     safety and tolerability of the combination of neratinib plus paclitaxel, trastuzumab and~     pertuzumab to determine the recommended Phase II/III dose of this combination.~      Neratinib will be given once daily days 1-21 and should be taken orally with food. Paclitaxel~     and trastuzumab will be given IV on days 1, 8, and 15 out of 21 day cycles. Pertuzumab will~     be given IV every 3 weeks on day 1 out of 21-day cycles. Each cycle will be 21 days in~     duration.~      Patients will continue on treatment until disease progression or intolerable toxicity.~   "
74350|NCT02593695|"~     Anorexia nervosa (AN) is a complex and severe psychiatric disorder with high relapse rates~     under standard treatment.Deep brain stimulation (DBS) may be a novel treatment in severe~     Anorexia nervosa.~   "
74351|NCT02593682|"~     The purpose of this study is to provide some information (pilot data) about whether the study~     drug, suvorexant, (1) affects levels of orexin in people with panic disorder, and (2) is~     associated with decreased panic symptoms in response to a carbon dioxide (CO2) challenge.~   "
74352|NCT02593669|"~     A cataract is a clouding of the crystalline lens inside the eye, which leads to a decrease in~     vision. It is the most prevalent, treatable cause of visual impairment and blindness in the~     world. Cataract surgery with an intraocular lens (IOL) implant is one of the most common and~     thought to be the most effective surgical procedure in any field of medicine. In this trial,~     the investigators aimed to evaluate the effect of cataract surgery on circadian rhythm and~     sleep as well as the effect of the blue light transmission characteristics of the implanted~     IOL on sleep.~   "
87950|NCT02415881|"~     Phase I trial to evaluate the safety of escalating dose levels of conjugated~     panitumumab-IRDye800 in subjects with head and neck squamous cell carcinoma (HNSCC) that~     undergo surgery with curative intent.~   "
74353|NCT02593656|"~     This study systematically quantified the effects of the Isagenix Performance System (IEPS)~     compared to a standard recommended control (C) diet both of which were combined with a~     4-day/week exercise training program on total and regional (abdominal) body composition (lean~     mass and fat mass), muscular strength and performance, flexibility, blood lipids and glucose,~     hormones, mood state and energy metabolism in 60 healthy middle-aged (25-55 years old) men~     and women following a 12-week intervention. Participants were enrolled in one of two cohorts:~        1. Isagenix Energy & Performance System, 2g/kg/Body Weight (BW) Protein (IEPS) (n=30)~             1. IEPS-I, n=15; consume protein feeding immediately after exercise~             2. IEPS-2, n=15; consume protein feeding 2 hours after exercise~        2. Control, 1g/kg/Body Weight Protein (C) (n=30)~   "
74354|NCT02593643|"~     Depression and suicidal ideation/attempt/death are major causes of morbidity and mortality~     from psychiatric illnesses. In 2009, the World Health Organization listed depression as the~     leading cause of years lost due to disability worldwide. Suicide is the 9th most common cause~     of death in Canada with 1.6% of Canadians ultimately dying from suicide (Statistics Canada,~     2012) and the 2nd most common cause of death in young people after accidental deaths. This~     information highlights the importance of finding treatments to prevent suicidal deaths.~      Ketamine has been shown to provide rapid treatment response for major depressive episodes~     both in major depressive disorder (MDD) and bipolar disorder (BD), via a single intravenous~     infusion which persists for at least 72 hours.~      The purpose of this study is to conduct a pilot trial of IV ketamine + treatment as usual~     (TAU) vs. midazolam (an active placebo) + TAU to estimate sample size for a full-scale RCT~     examining these treatments for decreasing suicidal ideation among depressed inpatients with~     major depressive disorder and bipolar depression.~      A total of 52 patients will be recruited for this trial. All subjects will be inpatients at~     Sunnybrook Health Sciences Centre with a diagnosis of either major depressive disorder or~     bipolar disorder type I or II currently depressed. Suicidal ideation must be present at~     baseline assessment in order to be included in the study. Thirteen subjects will be~     randomized to each treatment arm in each treatment stream - that is, 13 will be recruited to~     ketamine + TAU in the major depressive disorder stream, and 13 will be recruited to the~     midazolam + TAU in the major depressive stream. Likewise, 26 subjects with bipolar depression~     will be randomized to these two treatments.~   "
74355|NCT02593630|"~     This is a field case series of Unicirc under topical anaesthetic among adolescent boys, aged~     12 to 15 years.~   "
74356|NCT02593617|"~     The objective of this study is to investigate the prevalence of energy drink, alcohol and~     substance use among university students; to explore whether there is a relationship between~     energy drink consumption and alcohol-substance use in university students or not and to~     evaluate effect of impulsiveness and sensation seeking on this relationship.~   "
74357|NCT02593604|"~     Patients undergoing wide surgical excision of their hidradenitis suppurativa areas are asked~     by telephone about their quality of life by standard questionnaires (WHOQOL-BREF, DLQI,~     Skindex, MHF, FLQA-d) and their sexual function (FSFI, IIEF).~   "
74358|NCT02593591|"~     The next generation of personalized medical treatment according to the type of personal~     genetic information are evolving rapidly. The genome analysis needs systematic infra and~     database based on personal genetic information. Therefore, a big data of genome-clinical~     information is important.~      To determine the feasibility of the use of tumor's molecular profiling and targeted therapies~     in the treatment of advanced cancer and to determine the clinical outcome(Response rate,PFS,~     duration of response and overall survival )of patients with advanced cancer, the~     investigators are going to take a tumor tissue of patients and process molecular profiling~     and receive molecular profile directed treatments.~   "
74359|NCT02593578|"~     The next generation of personalized medical treatment according to the type of personal~     genetic information are evolving rapidly. The genome analysis needs systematic infra and~     database based on personal genetic information. Therefore, a big data of genome-clinical~     information is important.~      To determine the feasibility of the use of tumor's molecular profiling and targeted therapies~     in the treatment of advanced cancer and to determine the clinical outcome(Response rate,PFS,~     duration of response and overall survival )of patients with advanced cancer, the~     investigators are going to take a tumor tissue of patients and process molecular profiling~     and receive molecular profile directed treatments.~   "
74360|NCT02593565|"~     The purpose of this study is to learn about the experience of women with vasculitis who~     become pregnant. In particular, the study will consist of several online surveys to assess~        1. each woman's vasculitis severity and pregnancy-related experiences, and~        2. pregnancy outcomes.~   "
74361|NCT02593552|"~     This pilot study was done to assess the feasibility and possible efficacy of a video feedback~     intervention to improve the safety of cognitively impaired older drivers.~   "
74362|NCT02593539|"~     This is a multi-center, non-randomised, open-label, uncontrolled, single group study to~     investigate the safety and pharmacokinetics (PK) during 84 days repeat dosing treatment with~     1000 micrograms (mcg) of inhaled GSK2269557 in addition to standard of care, in subjects with~     activated phosphoinositide 3-kinase (PI3K) delta syndrome /p110delta-activating mutation~     causing senescent T Cells, lymphadenopathy and immunodeficiency (APDS/PASLI). To date~     GSK2269557 has been administered to healthy subjects (smokers and non smokers), subjects~     with: stable Chronic Obstructive Pulmonary Disease (COPD); subjects experiencing a COPD~     exacerbation; and subjects with persistent, uncontrolled asthma. As this study is the first~     administration of GSK2269557 to subjects with APDS, this study will provide safety,~     tolerability, efficacy and pharmacokinetic data in this patient population. Up to 20 subjects~     will be enrolled into the study. The total duration of the study is approximately 30 weeks,~     including pre-screening/screening and follow-up.~   "
74363|NCT02593526|"~     The proposed pilot study challenges the current widespread paradigm of discontinuing loop~     diuretics when initiating chronic HD and/or maintaining the dialysate at a constant~     temperature of 37 °C for all patients.~   "
74364|NCT02593513|"~     Prospective, single-center, single-blind, randomized, controlled, two-arm, interventional~     study.~   "
74443|NCT02592486|"~     The immunogenicity of simultaneous administration of quadrivalent influenza vaccine and~     pneumococcal vaccine was unknown. The purpose of present study is to compare the~     immunogenicity of simultaneous administration of influenza vaccine and pneumococcal vaccine~     with that of separate administration.~   "
74365|NCT02593500|"~     A SINGLE CENTER, SINGLE DOSE, OPEN-LABEL, RANDOMIZED, TWO PERIOD CROSSOVER STUDY TO DETERMINE~     THE BIOEQUIVALENCE OF TWO INHALATION FORMULATIONS CONTAINING BUDESONIDE 200 µg ADMINISTERED~     AS 3 PUFFS (TOTAL DOSE OF 600 µg) IN AT LEAST 52 HEALTHY MALES AND FEMALES UNDER FASTING~     CONDITIONS~      The study objective is to determine whether the inhaled test product, budesonide 200 µg~     (pressurized inhalation suspension) and the inhaled reference product, Budesonida Pulmictan®~     200 µg (budesonide; pressurized inhalation suspension) are bioequivalent.~      For this purpose the PK profile of budesonide will be compared after administration of a~     single dose of 600 µg (3 puffs) of each of the two inhalation formulations, under fasting~     conditions.~   "
74366|NCT02593487|"~     In many large trials, reducing low density lipoprotein (LDL) levels with rosuvastatin~     decreased the incidence of major cardiovascular events，but little attention to the effects of~     rosuvastatin on HDL level，especially on HDL subtype.~      Epidemiological evidence strongly favors the notion that the risk of cardiovascular disease~     (CVD) is inversely related to the plasma high-density lipoprotein (HDL) cholesterol~     concentration.~      HDL can be subdivided into large-sized (HDL2a, HDL2b) and small-sized subclasses (preb1-HDL,~     HDL3c, HDL3b, HDL3a) and preb2-HDL. Some studies indicate that only large HDL2a and HDL2b~     particles make HDLs possess anti-atherogenic functions.~      The investigators assume that rosuvastatin could play the role of anti-atherosclerosis though~     the levels of HDL2a、HDL2b increased.~   "
74367|NCT02593474|"~     The purpose of this open-label pilot study is to determine the tolerability and applicability~     of outpatient long-acting injectable naltrexone (Vivitrol) treatment in individuals age 16-25~     (older youth) with opioid use disorder. Outpatient treatment will consist of a 7-day~     outpatient detoxification / naltrexone induction procedure followed by 8-weeks of treatment~     with Vivitrol.~   "
74368|NCT02593461|"~     Prospective, single-center, single-blind, randomized, controlled, two-arm, interventional~     study.~   "
74369|NCT02593448|"~     The purpose of the present study is to assess, by near infrared spectroscopy with INVOS~     oximeter during vascular occlusion test (VOT), the influence of cardiopulmonary bypass on~     tissue saturation in thenar muscle.~      The secondary aim is to compare the effects of propofol and sevoflurane anaesthesia on tissue~     saturation.~      It is a prospective, randomized, open-label study. Sixty cardiac surgery patients will~     receive either propofol or sevoflurane anaesthesia. Three-minute VOT will be performed at the~     following time points: 30 minutes after anaesthesia induction, directly after sternotomy, 20~     and 40 minutes after aortic cross-clamping, 20 minutes after aortic cross-clamp removal, and~     45 minutes after weaning of cardiopulmonary bypass (CPB).~      Group and time effects on tissue saturation will be analysed with ANOVA and post hoc Tukey's~     test.~   "
74370|NCT02593435|"~     Purpose:~        1. Screening of large samples is to search the gene mutation of the breast cancer~          susceptibility gene (BRCA1 and BRCA2) in Chinese high risk group.~        2. To build the breast cancer BRCA1/2 mutation database of Chinese group.~        3. To build the hazard model of breast cancer BRCA1/2 mutation of Chinese group.~   "
74371|NCT02593422|"~     This online study aims to understand whether writing about one's experiences with ovarian~     cancer may be beneficial for psychological and physical wellbeing in women with a history of~     ovarian cancer. Investigators are also interested in studying how certain individual~     characteristics may impact the effectiveness of writing. Participants will be asked to~     complete an initial survey (15 min), followed by writing about their experiences with ovarian~     cancer on four occasions (20 - 25 min each), over the course of two weeks. A final survey (10~     min) will be completed one month afterwards.~   "
74372|NCT02593409|"~     Can HIV-specific immunity develop in HIV uninfected humans exposed to HIV whilst receiving~     antiretroviral pre-exposure prophylaxis (PrEP)? Investigators will investigate this~     possibility in commercial sex workers in Kampala who will be receiving Truvada PrEP for one~     year.~   "
74373|NCT02593396|"~     The purpose of this study is to assess the tolerability, safety, and efficacy of bupropion~     hydrochloride sustained-release in the treatment of sexual dysfunction in men on methadone~     maintenance therapy.~   "
74374|NCT02593383|"~     evaluate the safety and efficacy of Compound Adapalene and Clindamycin Hydrochloride Gel in~     treatment of chinese patients with acne.~   "
74375|NCT02593370|"~     The main objective of the trial is to complete a double-blinded randomized controlled trial~     with crossover design of a lumbosacral plexus block with the Suprasacral Parallel Shift~     technique guided by ultrasound/magnetic resonance (MR) image fusion vs. Suprasacral Parallel~     Shift guided by ultrasound by estimating sensory block of the femoral nerve, the obturator~     nerve, the lumbosacral trunk, and spinal nerve L1 in healthy volunteers.~   "
74376|NCT02593357|"~     The aim of the study is to assess the peripheral endothelial function in adult COPD (chronic~     obstructive pulmonary disease) patients and the relationship between the peripheral~     endothelial function and the pulmonary function.~   "
74377|NCT02593344|"~     The aim of the study is to assess the peripheral endothelial function in adult asthmatic~     patients and the relationship between the peripheral endothelial function and the pulmonary~     function.~   "
74378|NCT02593331|"~     This study will evaluate the safety and tolerability profile of BFKB8488A following~     subcutaneous (SC) administration in overweight and obese participants (body mass index [BMI]~     greater than [>] 27 to less than or equal to [</=] 40 kilograms per square meter [kg/m^2])~     with markers of insulin resistance. Single ascending fixed doses of BFKB8488A will be~     evaluated. Participants will be randomized into 7 sequential ascending fixed-dose cohorts of~     BFKB8488A SC or placebo and safety reviews will be performed before escalation to higher dose~     cohorts. Additionally, following the ascending fixed-dose SC cohorts, a separate cohort will~     open to evaluate the PK of BFKB8488A after intravenous (IV) administration.~   "
74379|NCT02593318|"~     The purpose of this study is to determine if oxaloacetate (OAA) is safe and tolerable at~     doses of up to 2 grams per day in people with Alzheimer's disease (AD).~   "
74380|NCT02593305|"~     The main purpose/s of this study is to examine the effects of 4 weeks of dietary nitrate~     supplementation on peripheral chemoreceptor sensitivity, spontaneous baroreflex sensitivity,~     and blood pressure responsiveness to a variety of physiological stressors in older healthy~     adults. We will also examine the effect of dietary nitrate supplementation on measures of~     central artery stiffness and aortic blood pressure in older adults.~   "
74383|NCT02593266|"~     The overall aim of this pilot study is to evaluate the acceptability and feasibility of an~     adaptation of Beardslee's 'Preventive Intervention Program (PIP) for Depression' in Chilean~     families.~      The PIP is a family intervention directed towards strengthening family functioning and~     enhancing resilience in children of depressed parents. It comprises several modules that work~     on psycho-education and skill development within the family nucleus.~      A single-blind randomized controlled trial will be conducted with two arms, the intervention~     arm (n=32) which will receive a home-based PIP for depression, and the TAU arm (n=32).~   "
74384|NCT02593253|"~     This single-blinded, cluster randomized control trial will assess the effectiveness of an~     audit and feedback bundle on internal medicine physician performance on selected quality~     metrics. The feedback bundle includes an electronic dashboard and weekly feedback rounds in~     which physicians will review their performance. The control arm will undergo audit and~     feedback per the current system, which is biweekly feedback emails with performance.~   "
74385|NCT02593240|"~     Worksites offer attractive locations for reducing the national prevalence of overweight and~     obesity. Interventions that are both effective and sustainable for producing long-term~     changes in health and employee wellness are urgently needed. In an 18-month worksite~     randomized controlled trial in 12 worksites this study will test two lifestyle approaches~     designed to facilitate behavior modification for achieving long-term improvements in health~     and quality of life. Worksites randomized to the immediate intervention arm will receive the~     two on-site wellness programs and the randomized control sites will participate in outcomes~     assessments for the initial 6 month period after which participants will receive vouchers to~     participate in the program of their choice. The primary focus of the worksite wellness study~     is to identify ways to improve health related quality of life, with a particular focus on a~     decrease in cardiometabolic risk factors, including weight, improved weight-related wellness,~     and improved energy level in work and life. The combination of 2 interventions will be tested~     against the control condition in an intention to treat model and with a completers analysis.~   "
74386|NCT02593227|"~     This Phase II trial evaluates the safety and immunogenicity of two doses of the Folate~     Receptor Alpha (FRα) peptide vaccine mixed with GM-CSF as a vaccine adjuvant, with or without~     a immune priming with cyclophosphamide, as a consolidation therapy after neoadjuvant or~     adjuvant treatment of patients with Stage IIb-III triple negative breast cancer (TNBC).~   "
74387|NCT02593214|"~     General objective:~      To assess the performance and safety profile of a novel innovative design of female condom~     (Wondaleaf®) among healthy married women.~      Specific objectives :~        -  To determine the failure rate of Wondaleaf®, in terms of clinical breakage, non-clinical~          breakage, invagination, misdirection, and slippage.~        -  To determine the acceptability and satisfaction of use of Wondaleaf® by subjects and~          their spouses.~        -  To assess the safety profile of Wondaleaf®.~   "
74388|NCT02593201|"~     Peritoneal dialysis (PD) is the first-line treatment of end stage renal disease (ESRD) in~     Hong Kong. Despite the advances in antibiotic therapy and connecting system, recurrent~     peritonitis remains the major cause of peritoneal failure. A recent study showed that an~     elevated bacterial DNA fragment levels in PD effluent 5 days prior to the completion of~     antibiotics predicts the development of relapsing or recurrent peritonitis episodes. We~     hypothesize that prolonged antibiotic therapy in PD patients with peritonitis and high PD~     effluent bacterial DNA fragment levels could prevent the development of relapsing and~     recurrent peritonitis. We plan to conduct a randomized control study of 360 patients with PD~     peritonitis. After inform consent, they will be randomized to receive one additional week of~     the effective antibiotic treatment (the Preemptive Treatment Group) or no additional~     treatment (the Control Group). Specimens of PD effluent will be collected 5 days prior to the~     completion of antibiotics for the measurement of bacterial DNA fragments. All patients will~     be followed for 6 months after completion of antibiotic therapy for the development of~     relapsing, recurrent, or repeat peritonitis episodes. Our study will determine the efficacy~     of a test-before-treat algorithm that could reduce the incidence of relapsing and recurrent~     peritonitis and, at the same time, minimize the unnecessary use of prolonged antibiotic~     treatment.~   "
74389|NCT02593188|"~     The purpose of the proposed study is to acquire additional data (including the assessment of~     anti-rHuPH20 antibodies) on the long-term safety of HYQVIA and to assess the prescribed~     treatment regimens and treatment administration in routine clinical practice.~   "
74390|NCT02593175|"~     The goal of this clinical research study is to learn if receiving 4 cycles of an experimental~     chemotherapy combination before surgery can help to shrink or slow the growth of tumors~     before they are removed through surgery. The safety of this combination will also be studied.~   "
74391|NCT02593162|"~     Phase 2a study designed to assess the safety, efficacy, and pharmacokinetics of Faldaprevir~     and TD-6450 in combination with Ribavirin for a 12-week treatment duration in treatment-naïve~     participants with genotype 4 hepatitis C virus (HCV) infection.~   "
74392|NCT02593149|"~     To assess blood stream infections in participants using two FDA-cleared devices: ClearGuard~     HD end caps compared to the Tego® connector with the Curos® for Tego disinfecting port~     protector.~   "
74393|NCT02593136|"~     This study evaluates the program effectiveness of home fortification along with infant and~     young child feeding (IYCF) counseling as a strategy to address anemia and complementary~     feedings gaps in a program setting of the Integrated Family Health Initiative being~     implemented by CARE India (a non-profit organization) in partnership with the Government of~     Bihar. The study also seeks to assess the field level worker experience with counseling and~     dissemination of home fortification products.~   "
74394|NCT02593123|"~     Determine the relapse-free, donor lymphocyte infusion (DLI)-free survival in patients~     receiving the investigational regimen.This is a randomized phase II clinical trial, comparing~     two different dosing schedules of mycophyenolate mofetil for graft versus host disease (GVHD)~     prevention following allogeneic stem cell transplantation. Risk for relapse, GVHD and~     non-relapse mortality will be assessed. Adaptive randomization between two study arms will be~     performed based on T cell counts at day 60.~   "
74444|NCT02592473|"~     The purpose of this project is to evaluate the safety, efficacy, and feasibility of~     performing prostatic artery embolization (PAE) using endovascular techniques and particle~     embolics in men suffering from lower urinary tract symptoms (LUTS) due to benign prostatic~     hyperplasia (BPH).~   "
74395|NCT02593110|"~     The TELEX trial will establish whether telmisartan alone improves walking performance in~     people with peripheral artery disease (PAD). The TELEX trial will also determine whether~     telmisartan plus supervised exercise improves walking performance more than either therapy~     alone. TELEX is a randomized controlled clinical trial (2 x 2 factorial design) of 240~     participants with PAD randomized to one of four arms: Group A: telmisartan + supervised~     exercise therapy; Group B: telmisartan + a no exercise control group; Group C: placebo +~     supervised exercise therapy; and Group D: placebo + a no exercise control group.~   "
74396|NCT02593097|"~     Migraine is the third most prevalent disease in the world. Preventive treatment is indicated~     in about 40% of individuals with episodic migraine. Although 4 treatments are approved by the~     US Food and Drug Administration for prevention of episodic migraine, none were designed to~     prevent migraine, efficacy is modest, and all have significant adverse-event profiles. As a~     result, less than 1/3 of migraine sufferers with who are candidates for prevention receive~     drug treatment and of those who are treated, more than 85% have discontinued the preventive~     drug within one year. Migraine pain is associated with the activation and sensitization of~     specific receptors involved in pain-promoting pathways. Metformin, which is a widely~     available, well-tolerated anti-diabetic medication, can downregulate pain-promoting pathways.~     Metformin has demonstrated positive results in animal models of migraine in the laboratory.~     Given the longstanding use and established safety record of metformin, the investigators will~     evaluate the safety and efficacy of metformin for preventive treatment of migraine in a~     randomized, double-blind, placebo-controlled, crossover trial.~   "
74397|NCT02593084|"~     Exercise programs, particularly resistance training programs using weights or resistance~     bands, can help improve or maintain mobility and function in older adults, preserve~     independent living, and improve quality of life. This study will examine the safety and~     feasibility of a novel, higher intensity resistance training program in older adults, and~     compare the effects with standard care, lower intensity training. It is anticipated that both~     programs will be safe and feasible, but higher-intensity training will lead to greater~     improvements in quality of life, mobility and strength, which are part of the physical~     phenotype definition of frailty and markers of mobility disability.~   "
74398|NCT02593071|"~     This study will enroll subjects who received the RSV F vaccine or placebo in the earlier~     study (RSV-E-201, Year 1) and re-randomize them to receive either vaccine or placebo in a~     second season. This design will permit evaluation of the safety and immunogenicity of~     revaccination in a second RSV season, and the safety and immunogenicity of revaccination over~     two years.~   "
74399|NCT02593058|"~     This study evaluates the addition of a 8 session psychological program, called Positive~     Emotions Program for Schizophrenia (PEPS) to improve motivation and pleasure in adults with~     schizophrenia. Half of the participants will receive their usual treatment and PEPS in~     combination, while the other half will receive usual treatment only.~   "
74400|NCT02593045|"~     The primary objective of this first in human study is to assess the safety and tolerability~     of increasing intravenous (IV) doses of single agent IPH4102 administered to patients with~     relapsed/refractory CTCL to characterize the dose limiting toxicities (DLT) and identify a~     Maximum Tolerated Dose (MTD).~   "
74401|NCT02593032|"~     Medication adherence is defined as the extent to which a patient takes his or her medication~     as prescribed by their healthcare provider. One third to one half of all patients in the~     United States do not take their medication as directed, resulting in nearly $100B in~     avoidable hospital costs per year. Recent efforts to improve medication adherence in patients~     with multiple comorbidities have turned to case management and disease management programs.~     Connected monitoring devices offer an alternative- or supplement- to frequent nurse visits~     and outreach. These devices enable frequent monitoring and intervention but can also generate~     large volumes of data that can be difficult for care teams to manage. The present study~     explores the use of one such device- a technology-enabled, connected pillbox. Given the~     continued emphasis on bending the cost curve in US healthcare, clinical validation of tools~     that may improve the management of costly chronic diseases, such as diabetes, is essential.~   "
74402|NCT02593019|"~     AZD1775 (previously known as MK-1775 in earlier studies) is an inhibitor of Wee1, a protein~     tyrosine kinase. Wee1 phosphorylates and inhibits cyclin-dependent kinases 1 (CDK1) and 2~     (CDK2), and is involved in regulation of the intra-S and G2 cell cycle checkpoints.~      CDK1 (also called cell division cycle 2, or CDC2) activity drives a cell from the G2 phase of~     the cell cycle into mitosis. In response to DNA damage, Wee1 inhibits CDK1 to prevent the~     cell from dividing until the damaged DNA is repaired (G2 checkpoint arrest).~      Inhibition of Wee1 is expected to release a tumor cell from chemotherapeutically-induced~     arrest of cell replication. In vitro experiments demonstrate that AZD1775 has synergistic~     cytotoxic effects when administered in combination with various DNA damaging agents that have~     divergent mechanisms of action. Therefore, the primary objective of the clinical development~     of AZD1775 is its use as a chemosensitizing drug in combination with a cytotoxic agent (or~     combination of agents) for treatment of advanced solid tumors.~      CDK2 activity drives a cell into, and through, S-phase of the cell cycle where the genome is~     duplicated in preparation for cell division. Inhibition of Wee1 is expected to cause~     aberrantly high CDK2 activity in S-phase cells which, in turn, leads to unstable DNA~     replication structures and ultimately DNA damage. Therefore, it is anticipated that AZD1775~     will have independent anti-tumor activity in the absence of added chemotherapy.~      The tumor suppressor protein p53 regulates the G1 checkpoint. As the majority of human~     cancers harbor abnormalities in this pathway they become more dependent on S- and G2- phase~     checkpoints. Thus, S- and G2-checkpoint abrogation caused by inhibition of Wee1 may~     selectively sensitize p53-deficient cells.~      One hundred percent of Small cell lung cancer has TP53 mutation, therefore we can expect that~     most of Small cell lung cancer have lost G1 checkpoint and has high probability of WEE1~     dependency for proper DNA repair and cell cycle progression. For this reason, Small cell lung~     cancer could be a good clinical trial target disease for WEE1 inhibitor.~   "
74403|NCT02593006|"~     STOP-JIA is a PCORI funded prospective observational study which will compare the clinical~     effectiveness and impact on patient reported outcomes of 3 Childhood Arthritis & Rheumatology~     Research Alliance (CARRA) consensus derived treatment strategies (CTPs) in new-onset~     polyarticular JIA (pJIA) patients to answer the critical question of when is the best time to~     begin biologic medications to achieve the optimal clinical and patient reported outcomes.~     Because the CARRA Registry will be used for data collection, all patients will be enrolled in~     the CARRA Registry. The standard of care treatments are chosen by the treating physician and~     patient/caregiver and are not randomized.~   "
74404|NCT02592993|"~     Open-label, prospective study. Up to 60 healthy adult volunteers seeking facial acne scars~     treatment, males or females of 18 to 75 years of age, from up to 3 investigational sites.~   "
74640|NCT02589925|"~     Phase 1 study evaluating the safety of combined bilateral subthalamic nucleus (STN) and basal~     nucleus of Meynert (NBM) stimulation in treating levodopa responsive motor symptoms of~     Parkinsonism and cognitive dysfunction in patients with advanced Parkinson's disease having~     mild to moderate dementia.~   "
74405|NCT02592980|"~     Background: Time in therapeutic range (TTR) is a measurement of quality of warfarin therapy~     and lower TTR values (<50%) are associated with greater risk of thromboembolic and bleeding~     events. Recently, the investigators developed a pharmacogenetic-based warfarin dosing~     algorithm specifically calibrated for a Brazilian patient sample. The newly developed~     algorithm was shown to be more accurate for individuals from the Brazilian population than~     algorithms developed from international samples. The aims of this study are: to evaluate the~     impact of a genetic-based algorithm, compared to traditional anticoagulation, in the time to~     achieve the therapeutic target and in TTR percentage; and to assess the cost-effectiveness of~     genotype-guided warfarin dosing in a specific cohort of patients with low TTR (<50%) from a~     tertiary cardiovascular hospital. Methods/Design: The investigators will recruit 300 patients~     with TTR<50% based on the last three INR values. At the first consultation, patients will be~     randomized into two groups: TA (Traditional Anticoagulation) group and PA (Pharmacogenetic~     Anticoagulation) group. For the first group, the physician will adjust the dose according to~     current INR value and, for the second group, a pharmacogenetic algorithm will be used. At the~     second, third, fourth and fifth consultations (with an interval of 7 days each) INR will be~     measured and, if necessary, the dose will be adjusted based on guidelines. Afterwards,~     patients who are INR stable will begin measuring their INR in 30 day intervals; if the~     patient´s INR is not stable, the patient will return in 7 days for a new measurement of the~     INR. The main outcomes will be the time to achieve the therapeutic target and the percentage~     of TTR at 4 and 12 weeks. In addition, as a secondary end-point, pharmacoeconomic analysis~     will be carried out. Discussion: With a sample size of 150 patients for each arm separately,~     the study will have a power of 93% to observe a difference of 10% between TTR means of the TA~     and PA groups. This randomized study will include patients with low TTR and it will evaluate~     whether a population-specific genetic algorithm might be more effective than traditional~     anticoagulation for a selected group of poorly anticoagulated patients.~   "
74406|NCT02592967|"~     The purpose of this study is to determine the recommended Phase 2 dose (RP2D) of JNJ-64041757~     a live attenuated double deleted (LADD) Listeria monocytogenes (bacteria in which two~     virulence genes, which encode molecules that help cause disease, have been removed) when~     administered intravenously to participants with advanced (Stage IIIb) or metastatic (Stage~     IV) NSCLC (adenocarcinoma).~   "
74407|NCT02592954|"~     Adult participants will apply a broccoli sprout extract-jojoba oil compound to one arm every~     night under occlusion for 1 week. Jojoba oil alone will be applied to the other arm. At the~     end of 1 week, a 6mm punch biopsy will be taken from both arms and analyzed via polymerase~     chain reaction (PCR) and immunohistochemistry for differences in various skin proteins.~   "
74408|NCT02592941|"~     The expanded access program will provide access to treatment with deflazacort in children,~     adolescent, and adult patients with DMD in the U.S. who are ineligible, unable, or otherwise~     unwilling to enroll in a clinical study examining the efficacy of deflazacort while a new~     drug application is under preparation and review. Enrollment is open to all eligible~     patients.~   "
74409|NCT02592928|"~     Background/Aims There is evidence indicating that deployment of forced spirometry (FS)~     testing in a collaborative scenario, encompassing respiratory specialists and community~     professionals, generates healthcare efficiencies. The study describes the roadmap for~     regional implementation of the FS program in Catalonia (ES), from January to December 2016.~      Methods/Design Firstly, the FS program will be deployed in three healthcare sectors (514 k~     inhabitants), following Plan-Do-Study-Act iterative cycles, using the Model for Assessment of~     Telemedicine for evaluation purposes. Thereafter, regional deployment of the FS program (7.5M~     inhabitants) will be conducted. The third step considers: evaluation of transferability,~     preparation for data analytics and recommendations for long-term assessment of outcomes. Main~     components of the FS program are: i) Automatic quality testing; ii) Standardized data~     transfer to a shared electronic health record; iii) Elaboration of individual FS reports~     including historical results; and, iv) Clinical decision support systems providing access to~     the FS report, and to remote support upon request.~      Discussion/Conclusions The project constitutes the first attempt to scale-up a collaborative~     scenario for FS testing that will open new avenues for longitudinal lung function assessment.~     Moreover, the setting shows high potential for transferability to different sites and to~     other diagnostic procedures.~   "
74410|NCT02592915|"~     The purpose of this study is to assess the effect of IV clonidine administration on lower~     limb spinal motoneuron excitability during standardized total intravenous anesthesia~     (propofol and remifentanil).~   "
74411|NCT02592902|"~     The purpose of the study was to determine, whether patients with recurrent respiratory~     papillomatosis (RRP) suffer from extra oesophageal reflux more often than patients with~     laryngeal cyst (control group).~   "
74412|NCT02592889|"~     Functional mitral regurgitation (FMR) is a common finding in patients with dilated~     cardiomyopathy and reduced left ventricular ejection fraction (LVEF). The presence of a~     relevant FMR (grade ≥2) is associated with a higher morbidity and mortality. Cardiac~     resynchronization therapy (CRT) has been shown to be effective in patients with dilated~     cardiomyopathy and reduced LVEF. In selected patients, CRT has been linked to clinical~     improvement and reduced mortality. Importantly, 38% of patients with clinical indication for~     CRT present moderate or severe (FMR). Although FMR might be reduced after CRT, the~     persistence of a relevant FMR (≥2) after CRT ranges between 40% and 50% and is an independent~     predictor of no clinical response. In these patients, surgical FMR correction is frequently~     turned down as a result of a high surgical risk. Percutaneous repair of the mitral valve with~     the MitraClip system has demonstrated promising results in patients with dilated~     cardiomyopathy and reduced LVEF5. In a cohort of patients with no response to CRT and FMR ≥2,~     Auricchio et al showed significant clinical improvement with LVEF recovery and reduction in~     left ventricle (LV) volumes after MitraClip. The absence of randomization, the retrospective~     nature of the study and the subsequent selection biases were however major limitations that~     impeded solid conclusions. The objective of the present study is to assess the efficacy and~     safety of the MitraClip system in non-responders to CRT and FMR ≥2.~   "
74413|NCT02592876|"~     The purpose of this randomized, open-label study is to evaluate the safety and efficacy of~     denintuzumab mafodotin plus RICE (rituximab, ifosfamide, carboplatin, and etoposide) when~     compared to RICE alone in the treatment of patients with relapsed or refractory diffuse large~     B-cell lymphoma (DLBCL) or Grade 3b follicular lymphoma. Eligible patients must also be~     candidates for autologous stem cell transplant. Patients will be randomly assigned in a 1:1~     ratio to receive 3 cycles of study treatment with either denintuzumab mafodotin + RICE or~     RICE alone. The study will assess whether there is a difference between the 2 groups in the~     side effects that are reported and the number of patients who achieve complete remission at~     the end of their study treatment.~   "
74527|NCT02591394|"~     The Stroke Transitions Education and Prevention (STEP) Clinic is a new type of clinic~     designed for stroke patients and was established to provide a comprehensive approach to~     stroke risk factor reduction. The goal of this study will be more effective than usual care~     at reducing blood pressure in patients with poorly controlled blood pressure after an~     ischemic or hemorrhagic stroke or transient ischemic attack.~   "
74414|NCT02592863|"~     Imbalance, dizziness and vertigo as a result of problems in the inner ear (vestibular~     dysfunction) are becoming increasingly more prevalent in Americans 40 years of age and older.~     The symptoms have a severe impact on affected individuals with detrimental effects on work,~     travel, social and family life. These patients see doctors often with no relief in their~     symptoms.~      The most promising help for these patients is to use medication that will increase blood flow~     to the inner ear. Pentoxifylline (Trental) has been shown to increase microvascular blood~     flow.~   "
74415|NCT02592850|"~     Tension-type headache (TTH) is a very common primary headache disorder, with important costs~     for both patients and society. Often these patients are not willing to take prophylactic~     medications and resort to complementary therapies. Osteopathic manipulative treatment (OMT)~     is an interesting option in such field, since it is characterized by a low profile of side~     effects.~      In this study the investigators will assess the efficacy of OMT (semi-structured evaluation~     and black box treatment) in frequent Episodic TTH (ETTH) in an outpatient setting.~     Preliminary data for power calculation are already available (Rolle et al. 2014), and the~     investigators plan to recruit 264 ETHH patients by a multicentric, randomized, double-blind,~     sham-controlled design.~   "
74416|NCT02592837|"~     Endobronchial ultrasound (EBUS) guided transbronchial needle aspiration (EBUS-TBNA) is an~     excellent tool for sampling enlarged mediastinal and hilar lymph nodes, but only provides~     needle aspirate samples which are often adequate for cytological examination only. More~     advanced histopathological and immunocytopathological assessment of tissue samples, which is~     particularly important in the diagnosis and staging of cancer, is often not possible with the~     small cellular samples obtained by EBUS-TBNA. A new transbronchial nodal aspiration needle~     (the Flex 19G EBUS-TBNA needle) has been developed with a larger needle diameter and more~     flexibility at the distal end, allowing better access to some lymph nodes stations. This~     needle can be passed down an EBUS scope and can hypothetically circumvent the deficiencies of~     EBUS-TBNA highlighted above by providing tissue adequate for histological assessment rather~     than cytological assessment alone.~      This study aims to establish whether the use of the Flex 19G EBUS-TBNA needle can improve the~     diagnostic yield of EBUS sampling procedures compared to the use of the conventional TBNA~     needle, thereby allowing more accurate diagnoses and reducing the need repeat procedures or~     more invasive surgical biopsies, without causing an increase in complication rates. Patients~     with enlarged mediastinal and hilar lymph nodes referred for EBUS-TBNA will be randomised to~     have their nodes sampled by either the EBUS-TBNA needle (conventional procedure) or the novel~     Flex 19G EBUS-TBNA needle. The investigators hope to recruit 250 patients over a 24 month~     period.~   "
74417|NCT02592824|"~     The aim of GLUTAMICS II is to evaluate whether intravenous glutamate infusion surgery reduces~     the risk of postoperative heart failure as measured by plasma NT-proBNP in patients~     undergoing moderate to high-risk coronary artery bypass graft surgery. Patients accepted for~     coronary artery bypass surgery of at least two vessel disease or left main stenosis with or~     without concomitant procedure and considered to be at moderate to high surgical risk~     preoperatively with regard to postoperative heart failure will be studied. The primary~     endpoint is postoperative increase of NT-proBNP from the day before surgery to the third~     postoperative day.~   "
74418|NCT02592811|"~     Bile duct stone extraction is impossible after endoscopic sphincterotomy (ES) alone in~     approximatively 10% of cases (mostly because of stones' size). Adjunction of a mechanical~     lithotripsy (ML) is well established to improve clearance of common bile duct (CBD) stones.~     Because of inconstant success, high cost, and length of procedure, an alternative method was~     proposed in 2003: endoscopic sphincterotomy plus large balloon dilatation (ESLBD). If the~     safety of ESLBD is accepted in all recent published studies, it remains controversial wether~     ESLBD is superior to conventional endoscopic treatment associating ES± ML for CBD stones.~     Procedure treatment and place of ESLBD in CBD stones therapeutic strategy is unclear.~      The purpose of this prospective comparative multi center randomized study is to evaluate the~     superiority or not of ESLBD on conventional treatment (ES±ML) for the treatment of large bile~     duct stone (≥13mm) after standard ES, and to propose a new CBD stones therapeutic strategy.~   "
74419|NCT02592798|"~     The purpose of this study is evaluate if abatacept is effective and safe in decreasing the~     level of protein loss in the urine in patients with excessive loss of protein in the urine~     (nephrotic syndrome) due to either focal segmental glomerulosclerosis (FSGS) or minimal~     change disease (MCD). Candidates must have a prior kidney biopsy with either diagnosis.~     Another kidney biopsy will not be required as part of the study. Candidates must have failed~     or be intolerant of prior therapy for their kidney disease. The failed or intolerant therapy~     must include corticosteroids and at least one other drug. Candidates can be adults and~     children over the age of 6. Abatacept will be administered by venous infusion every 4 weeks.~   "
74420|NCT02592785|"~     Primary objectives of this study are to assess the safety and tolerability of BAY 1163877 in~     Japanese subjects with refractory, locally advanced or metastatic solid tumors and to~     characterize the PK of BAY 1163877~   "
74421|NCT02592772|"~     This study examines the potential effect of reducing nicotine content or menthol or both in~     men. It will also examine whether there are gender differences in manipulating tobacco~     flavors and nicotine concentrations in cigarettes on smoking behavior.~   "
74422|NCT02592759|"~     The purpose of this study is to evaluate the therapeutic effects of smart glove which is~     motion-based program designed for upper extremity rehabilitation after stroke.~   "
74440|NCT02592525|"~     This study will train health providers in home care teams across Quebec in shared decision~     making about the decision to stay at home or move to another location. This decision is one~     of the toughest for older Canadians. Decisions that are informed, shared and supported~     produce better results. An interprofessional approach to shared decision making is when older~     persons and their caregivers are supported by not just one but by all the professionals~     involved in their care.The impact of the training program in interprofessional shared~     decision making (IPSDM) above that of the passive dissemination of a decision guide will be~     assessed by measuring to what extent older persons caregivers say they took active part in~     the decision-making process.~      Other outcome measures will be:~      i) what option they chose, whether they feel conflict or regret about their decision, and the~     burden of care they feel; ii) the quality of life of clients;~   "
74423|NCT02592746|"~     Despite recent advances for the treatment of post-menopausal hormone receptor-positive BC, in~     the last decade there was no major improvement of hormonal therapy specifically for~     premenopausal metastatic breast cancer. The median age of breast cancer is much younger, and~     the proportion of young breast cancer (YBC) patients (less than 40) including premenopausal~     women is much higher, in Asia, including Korea.~      Capecitabine, the comparator in this trial, is an orally-administered fluoropyrimidine~     derivative and has shown high efficacy and low toxicity in metastatic breast cancer patients.~     Palbociclib is a CDK4/6 inhibitors, in combination with endocrine therapy showed marked~     advance in hormone receptor-positive MBC in the post-menopausal setting. After a median~     follow-up of 16.5 months, preliminary results from Part 1 of this Phase 2 trial suggest that~     the combination of PD-0332991 with letrozole is superior to letrozole alone, and improved~     objective response and disease control rates (52% vs 32% and 76% vs 47%, respectively) in~     patients treated with the combination. These remarkable results may contribute to have much~     benefit with endocrine therapy for premenopausal women. Most importantly, recent PALOMA-3~     trial revealed superior results of adding palbociclib to fulvestrant (median PFS 9.2 vs 3.8~     months, P<0.001).~      Based on these rational backgrounds, the purpose of this phase II study is to assess the~     safety and the clinical anti-tumor activity of exemestane plus goserelin acetate in~     combination with palbociclib vs capecitabine in premenopausal hormone receptor-positive~     advanced breast cancer patients~   "
74424|NCT02592733|"~     This is an observational trial to determine if use of fusion imaging in infrarenal~     endovascular aneurysm repair will decrease the radiation dose and improve patient safety for~     this procedure.~   "
74425|NCT02592720|"~     This is a randomized, single blind, controlled study of intracoronary cocktail injection~     before fractional flow reserve (FFR) measurement when guiding percutaneous coronary~     intervention (PCI) in patients with acute coronary syndrome (ACS).~   "
74426|NCT02592707|"~     The purpose of this clinical phase I/II study is to investigate the safety and tolerability~     of 177Lu-OPS201 used for the treatment of patients with neuroendocrine tumors (NETs).~     Secondary objectives of these study are the assessment of biodistribution, dosimetry and~     preliminary efficacy of 177Lu-OPS201.~   "
74427|NCT02592694|"~     This is a randomized, double blind, placebo controlled study of intracoronary cocktail~     injection combined with thrombus aspiration versus thrombus aspiration alone in ST-elevation~     myocardial infarction patients treated with primary angioplasty.~   "
74428|NCT02592681|"~     This study is designed to make comparisons between acupuncture and acupressure for preventing~     menstrual migraine (MM). Whether acupuncture is superior to acupressure is the most~     interesting point of this study. First of all, females will be screened for eligibility.~     Then, all participants who meet the inclusion criteria will be asked to keep a headache~     migraine diary for three months as baseline data. The diaries will then be collected before~     the first treatment. Then, all the participants will receive the corresponding interventions~     on the eighth, fifth and second days before the estimated first day of menstruation~     (determined individually from the diaries) in each month for three months (menstrual cycle),~     making a total of nine treatment sessions. After the whole treatments, there will be a~     three-month follow-up period. All the participants will be asked to complete the headache~     diaries every month from baseline to the end of the study. The diaries recording data from~     the fourth to the ninth month will then be collected at the end of the ninth month for the~     second time indicating the end of the study for the participants. In case of an acute~     migraine attack, participants will not be restricted from using normal medications.~   "
74429|NCT02592668|"~     This is a feasibility study to test the use of epidural stimulation to restore volitional~     function previously lost due to spinal cord injury.~      Previous studies conducted in animal models, performed elsewhere and here at Mayo Clinic,~     have shown that direct electrical stimulation of the spinal cord increases the excitability~     of spared neuronal connections within the site of injury, thereby enhancing signal~     transmission and allowing recovery of previously lost volitional function. Recently, epidural~     electrical stimulation of the lumbosacral spinal cord in four individuals with spinal cord~     injury (SCI) has restored motor and autonomic function below the level of injury. Despite~     positive results, further translational research is needed to validate these findings. The~     goal of this proposal is to perform epidural stimulation to restore volitional function in~     patients with SCI. In two patients, we will implant an epidural stimulator onto the dorsal~     aspect of the lumbosacral spinal cord dura mater. Patients will undergo a structured program~     of daily physical rehabilitation, treadmill step training, and epidural stimulation to~     recover motor, sensory, and autonomic function.~   "
74430|NCT02592655|"~     This cross-over study of twenty five (anticipated) healthy human subjects will utilize two~     active control devices, and two different widths of the investigational device. One active~     control is representative of the usual care tourniquet applied in hospital settings. The~     second active control is a windlass tourniquet representative of the pre-hospital and~     military usual care tourniquet device. Two inch and four inch widths of the investigational~     device will be evaluated. The purpose of this study is to characterize and compare~     investigational and control tourniquet safety and efficacy. All tourniquets will be applied~     to the upper thigh. Efficacy data is provided by the presence or absence of popliteal flow~     when assessed with ultrasound. Mapping of interface pressures between the skin and the~     tourniquet will provide safety data. A minimum washout of five minutes will be allowed~     between tourniquet applications. All interventions will be applied in one visit. No follow up~     visit is anticipated.~   "
74441|NCT02592512|"~     This study evaluates the difference between Non Invasive Ventilation with Neurally Adjusted~     Ventilatory Assist (NIV-NAVA) and Conventional Non Invasive Ventilation with Pressure Support~     (PS) or Pressure Control (PC). All the patients are ventilated in each mode for 4 hours.~     Afterwards they will be subjected to a semi-structured interview where they will be asked to~     compare the two modes. The hypothesis is that NIV-NAVA will correct patients power of~     Hydrogen (pH), PaCO2 og PaO2 more quickly than NIV-PS and NIV-NAVA is more comfortable for~     the patients.~   "
74442|NCT02592499|"~     The study is a prospective, randomized, non-blinded, national, multi-center study. The study~     will consist of the assignment of eligible patients to treatment with either a HeartMate III~     (HM III) left ventricular assist device system or to pharmacological treatment (optimal~     medical management, OMM) according to current guidelines. One hundred and forty (140)~     patients will be enrolled in this study and randomized in a 1:1 fashion between the HM III~     and OMM.~   "
74431|NCT02592642|"~     Arthritis of the spine causes narrowing of the spinal canals and compression of the spinal~     nerves traveling into the legs, limiting walking ability. The vast majority of individuals~     with arthritis of the spine are not suited for surgery and most receive non-surgical~     treatment. However, we do not know what non-surgical treatments are effective in improving~     walking in these people. The purpose of our research is to test four new treatments for~     arthritis of the spine to see if they can improve walking ability. Each treatment approach~     focuses on the changes that occur in the spine and the whole person as a result of the~     arthritis that directly or indirectly impacts the ability to walk and perform usual daily~     activities. Because arthritis of the spine is a chronic condition usually does not go away,~     it is important that people acquire the knowledge, skills, and tools to manage their~     condition on their own. The treatments that investigators plan to test as part of this~     research proposal are aimed at achieving this goal. However, before the investigators can~     promote the use of these treatments they need to formally test them using strict scientific~     methods to make sure they do more good than harm. The four treatments include 1) a six week~     training program referred to as Boot Camp for Stenosis which provides one-on-one training~     on exercise and self-management strategies 2) a patient educational workbook and video on how~     to self-manage, 3) an electrical device that is placed on the lower back to reduce nerve pain~     when walking and 4) a spinal stenosis belt that people can wear to reduce pressure on the~     nerves while walking. The plan is to assess the change in walking distance using the various~     treatments and assess what impact the treatments have on peoples' overall function and~     quality of life. Innovative treatment approaches with a long term perspective are urgently~     needed to deal with the growing number of people with arthritis of the spine who are~     disabled. It is likely that there is not one solution to this problem - many people will~     require more than one type of treatment, but an important first step is to determine which~     treatments are effective, then tailor the treatments to the needs of each person.~   "
74432|NCT02592629|"~     The specific aim of this prospective study is to determine whether local anesthetics prior to~     subacromial steroid injections reduce pain and consequently if they are cost-effective in the~     treatment for shoulder pathology.~   "
74433|NCT02592616|"~     Four months of interval walking (IW) training results in substantial weight loss in~     opposition to energy-expenditure matched continuous walking (CW) training. The reason for~     this is unclear.~      This study will assess if IW leads to greater exercise-induced suppression of appetite and ad~     libitum food intake compared to CW and no exercise.~      Subjects with type 2 diabetes will be included in a crossover, counter-balanced, controlled~     study, where each subject will undergo three trials. Trials will be identical except the~     following interventions:~        1. One hour of rest (CON)~        2. One hour of interval walking (repeated cycles of 3 min of fast and 3 min of slow~          walking; IW)~        3. One hour of continuous walking (CW) matched to IW with regards to energy-expenditure.~      After the interventions subjects will undergo a liquid mixed meal tolerance test (450 kCal),~     with regular measurements of appetite-related hormones (insulin, ghrelin, Leptin,~     Cholecystokinin, PYY). Three hours into the mixed meal tolerance test, a standardised~     ad-libitum meal test will be served and intake will recorded. Free-living energy intake via~     food records will be assessed during the following 32 hours.~   "
74434|NCT02592603|"~     Serrated Polyposis Syndrome (SPS) is a high-risk condition for colorectal cancer (CRC). SPS~     patients have a cumulative CRC risk of 1.9% in 5 years despite a strict endoscopic~     surveillance in specialized centers. Proximal serrated lesions are endoscopically challenging~     to detect due to their unremarkable morphology. Endocuff is a novel device comprised of a cap~     with a row of finger-like projections with a unique dynamic shape that help to flatten~     mucosal folds during withdrawal of the instrument in order to improve detection of lesions.~     Recent studies have reported an increase of detection rate and mean per patient of adenomas~     with Endocuff-assisted Colonoscopy compared with Standard Colonoscopy. The purpose of this~     study is to assess the usefulness of Endocuff-assisted Colonoscopy to detect serrated lesions~     in SPS patients undergoing surveillance compared to Standard Colonoscopy in a randomized~     fashion~   "
74435|NCT02592590|"~     The purpose of this study is to determine the individual and combined effectiveness of two~     smartphone-based tools for improving physical activity. The first is an individualized and~     guided goal-setting module, and the second uses points, levels, and badges to provide~     instant positive feedback throughout the program. It is hypothesized that both components~     will be effective, and greater effects will be noted for those receiving both components.~   "
74436|NCT02592577|"~     This first time in human study is intended for men and women at least 18 years of age who~     have advanced lung cancer which has grown or returned after being treated. In particular, it~     is a study for subjects who have a blood test positive for HLA-A*02:01 and/or HLA-A*02:06 and~     a tumor test positive for MAGE A10 protein expression (protein or gene). This trial is a dose~     escalation trial that will evaluate 3 doses of transduced cells administered after a~     lymphodepleting chemotherapy regimen using a 3+3 dose escalation design .The study will take~     the subject's T cells, which are a natural type of immune cell in the blood, and send them to~     a laboratory to be modified. The changed T cells used in this study will be the subject's own~     T cells that have been genetically changed with the aim of attacking and destroying cancer~     cells.~      When the MAGE A10ᶜ⁷⁹⁶T cells are available, subjects will receive lymphodepleting~     chemotherapy with cyclophosphamide and fludarabine, followed by the T cell infusion. The~     purpose of this study is to test the safety of genetically changed T cells and find out what~     effects, if any, they have in subjects with lung cancer. The study will evaluate three~     different cell dose levels in order to find out the target cell dose. Once the target cell~     dose is determined, additional subjects will be enrolled to further test the safety and~     effects at this cell dose.~      Subjects will be seen frequently by the Study Physician right after receiving their T cells~     back and up to first 6 months. After that, subjects will be seen every three months. Subjects~     will be seen every 6 months by their Study Physician for the first 5 years after the T cell~     infusion. If the T cells are found in the blood at five years, then the subjects will~     continue to be seen once a year until the T cells are no longer found in the blood for a~     maximum of 15 years. If the T cells are no longer found in the blood at 5 years, then the~     subject will be contacted by the Study Physician for the next 10 years. Subjects who have a~     confirmed response (or have stable disease for >4 months) but subsequent disease progression~     following the initial infusion and whose tumor continues to express the appropriate antigen~     target may be eligible for a second infusion. All subjects, completing or withdrawing from~     the Interventional Phase of the study, will enter a 15-year long-term follow-up phase for~     observation of delayed adverse events, All subjects will continue to be followed for overall~     survival during the long-term follow-up phase.~   "
74437|NCT02592564|"~     This study evaluates underlying psychological and biological mediators in Internet-delivered~     cognitive behavior therapy for adults with social anxiety disorder.~   "
74438|NCT02592551|"~     The objective of this study is to determine whether MEDI4736 or combination therapy with~     MEDI4736 + tremelimumab are associated with favorable alterations of the intratumoral~     immunologic environment in subjects undergoing resectional surgery for Malignant Pleural~     Mesothelioma MPM.~   "
74439|NCT02592538|"~     Endobiliary radiofrequency ablation (RFA) with biliary stent has been reported to be a~     beneficial treatment option for palliation of malignant biliary strictures. RFA uses a~     high-frequency alternating current to generate heat and achieve coagulative necrosis when in~     contact with tissue. Within the bile duct, RFA appears to be safe and may result in decreased~     tumor ingrowth. However, most of therapeutic effects were expected to delay bile duct~     obstruction rather than to decrease the tumor. Recently orally available chemotherapeutic~     agent, S-1, an oral fluoropyrimidine, was reported as effective in patients with bile duct~     adenocarcinoma. To date, little is known about the role of the addition of systemic~     chemotherapy to RFA for cholangiocarcinoma. The aim of this study is to evaluate the combined~     effect of RFA and S-1 in patients with unresectable cholangiocarcinoma.~   "
74445|NCT02592460|"~     Animal studies have shown that the level of pain sensitivity is highly dependent on the~     amount of polyamines in food. This fundamental observation of a nutritional approach to pain~     led the authors to develop diets completely depleted in polyamines whose anti-nociceptive~     properties have been confirmed in animals.~      Postoperative pain after foot surgery are currently fairly well controlled but at the cost of~     a high consumption of grade II analgesics which is associated with a high rate of side~     effects (nausea, vomiting ...). The investigators' hypothesis is that a diet low in~     polyamines may have an additive effect on pain control and reduce the consumption of level 2~     analgesics.~      The objective of this study is to show the efficacy of a polyamines-poor diet on~     postoperative pain in ambulatory surgery of the foot.~   "
74446|NCT02592447|"~     The purpose of this study is to evaluate Cognitive Behavioral Intervention for Targeted~     Therapy Fatigue (CBT-TTF) with fatigued chronic myelogenous leukemia (CML) patients on~     tyrosine kinase inhibitors (TKIs) for feasibility, acceptability and potential efficacy~     relative to usual care only in a small-scale randomized controlled trial.~   "
74447|NCT02592434|"~     Evaluate efficacy, safety and tolerability of tofacitinib in pediatric JIA patients.~   "
74448|NCT02592421|"~     In Protocol 2, the investigators will determine the role of pancreatic hormones (increase in~     plasma glucagon and decrease in plasma insulin concentration) in the stimulation of EGP~     following SGLT2 inhibition.~   "
74449|NCT02592408|"~     This is a randomized controlled trial to assess the efficacy and safety of the national~     malaria treatment guidelines, asses the efficacy and safety of artesunate and sulphadoxine -~     pyrimethamine (AS+SP) for treatment in uncomplicated P. falciparum and P. vivax malaria and~     the hematologic effect of 14 days routine primaquine based radical cure in patients suffering~     from a P. vivax or mixed infection.~   "
74450|NCT02592395|"~     The purpose of this study is to see how well electrochemotherapy works at treating people~     with Stage III pancreatic adenocarcinoma. Electrochemotherapy is a treatment that combines~     electroporation and chemotherapy administration. Electroporation uses an electric current to~     produce holes in pancreatic tumor, which causes the tumor cells to die or take up a higher~     concentration of administered chemotherapy agent. This study will test the safety and look at~     the effect of electrochemotherapy in the treatment of stage III pancreatic adenocarcinoma.~     This study will also help to find the safest and most effective amount of electroporation~     voltage to apply to this type of tumor.~   "
74451|NCT02592382|"~     Acute otitis media (AOM) is one of the most prevalent and costly illnesses in children~     throughout the world. AOM can lead to chronic otitis media with effusion (OME) resulting in~     conductive hearing loss that can cause speech, language, academic, and social developmental~     delays.~      Complementary and alternative medicines are being widely used for prevention of AOM.~      Xylitol is a five carbon polyol (sugar alcohol) produced from natural plants and is used for~     preventing dental caries and AOM in children. It is commercially available in chewing gums,~     syrups and toothpastes washes, and other products. Xylitol was shown in several studies to~     prevent the culture if bacteria in the nasopharynx and oral cavity. It was proven to~     eliminate the ability of bacteria to attach to the mucosa of the upper respiratory system.~      In this study the investigators aim to test the yield of Xylitol nasal spray compared to~     isotonic saline spray in prevention of recurrent AOM.~   "
74452|NCT02592369|"~     Prospective, single arm, multi-center, observational, post market study to document the~     clinical and device performance outcomes of the Evolut R system used in routine hospital~     practice in a large patient cohort for the treatment of symptomatic native aortic valve~     stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure~     necessitating valve replacement.~   "
74453|NCT02592356|"~     The goal of this clinical research study is to learn about possible weight, muscle, and/or~     fat loss in patients receiving cabozantinib or lenvatinib.~   "
74454|NCT02592343|"~     The primary goal is to study patients with recurrent Clostridium difficile Infection (CDI)~     treated with lyophilized Fecal Microbiota Transplantation (FMT) in an open-labelled~     controlled trial. The treatment failure rate will be evaluated as defined by the persistence~     of diarrhea and a positive C. difficile toxin assay. The safety, clinical response, and~     relapse rate in patients will be assessed.~   "
74455|NCT02592330|"~     The main aim of the study is to determine the safety and feasibility of a cultivated~     autologous limbal epithelial cell (CALEC) transplantation in the treatment of limbal stem~     cell deficiency.~   "
74456|NCT02592317|"~     The purpose of this study is to evaluate the effects of repeat dosing of JNJ-56021927 on the~     pharmacokinetics for single-dose multiple cytochrome P450 (CYP450) enzymes (CYP3A4, CYP2C9,~     CYP2C19, CYP2C8) and transporter (P-gp and BRCP) substrates in participants with~     castration-resistant prostate cancer (CRPC).~   "
74457|NCT02592304|"~     Endpoints subproject 1: To develop a reproducible method for the detection of lymph nodes by~     DECT in operation specimens from rectal resection for cancer. sub project 2: Primary~     endpoint: To evaluate the sensitivity and specificity for malignant lymph nodes in vitro RC~     specimens compared with histopathology. Secondary endpoint: To assess DECT as imaging tool~     for the diagnosis of malignant lymph nodes at RC. Histopathology will be used as~     reference.Subproject 3: Primary endpoint: To compare the sensitivity, specificity, positive-~     and negative predictive values, accuracy of DECT and standard MRI. Secondary: To evaluate the~     value of the gold standard for the use of imaging methods for the description of the lymph~     node, validated by histopathology. Secondary: to determine the value of tumor diagnostics~     using DECT.subproject 4: To assess the value of DECT as imaging tool for diagnosing response~     to chemo radiotherapy of malignant lymph nodes.~   "
74458|NCT02592291|"~     This study will assess the benefits of using mobile health system designed for individuals~     with chronic and complex health conditions (such as those with Spinal Cord Injury,Cerebral~     Palsy, Spina Bifida, and Traumatic Brain Injury) to improve their wellness and~     self-management skills compared to those who receive standard of care only.~   "
74470|NCT02592135|"~     The purpose of this study is to better understand myocardial injury in AHF. Secondary~     analyses demonstrate the prognostic significance of troponin release. The absence of such~     release has been associated with less risk. Whether measurement of high sensitivity TnT may~     enable emergency physicians to better risk stratify acute heart failure patients remains to~     be determined. This study will help us to better understand the prognostic value of absent or~     low hsTnT values in the emergency department setting. In addition, we will also test the~     STRATIFY decision rule; a risk score.~   "
74459|NCT02592278|"~     The aim of this study is to determine the effectiveness of fluoride varnishes in the~     prevention of dental caries lesions in erupting permanent first molars, in high-risk~     patients. Using as reference ICDAS criteria, when the success means that the surface maintain~     an ICDAS value 0 and failure that has change in ICDAS value 0 to 1.~      Sample: The sample comprise 180 patients between 6-7 years old with high-risk of dental~     caries.~      Study design: It proposed an experimental design randomized into 3 groups according to the~     frequency of topical fluoride application.(Group A: every 6 month; Group B: every 3 month;~     Group C: positive control).~   "
74460|NCT02592265|"~     The objective of this study is to measure economic burden of Multiple Sclerosis (MS) from a~     new point of view that includes consequences of disability on Quality Of Life (QOL), social~     participation and capabilities of patients and caregivers. To the investigators' knowledge,~     there is currently no data including intangible costs related to caregivers and calculating~     the overall economic cost of Multiple Sclerosis, particularly, in France.~   "
74461|NCT02592252|"~     Violence against women and girls is increasingly recognized as a major global public health~     and development concern. However, evidence on what forms of intervention should be~     prioritised is severely lacking. A cluster randomized controlled trial (The Intervention with~     Microfinance for AIDS & Gender Equity - IMAGE Project) in rural South Africa combined a~     group-based microfinance intervention with a participatory gender and HIV training curriculum~     for loan participants and showed that, over a two-year period, levels of physical and/or~     sexual partner violence experienced by participants in the past year were reduced by 55%.~      The overall goal of the current study is to design and implement a cluster randomized~     controlled trial to assess the impact on intimate partner violence of: 1) combining~     participatory gender training with microfinance for women in existing microfinance loan~     groups, and 2) a participatory gender training programme for women (not receiving~     microfinance) and their male partners.~   "
74462|NCT02592239|"~     The purpose of this study is to determine the relationship between brain activity and the~     perception of subjective hedonic sensations in response to a meal using functional MRI.~   "
74463|NCT02592226|"~     The ventilation of the patient under general anesthesia is an old problem and extensively~     studied, especially in visceral surgery, higher risk of postoperative complications. Studies~     have recently shown the impact of a lung-protective ventilation in visceral surgery, however~     obese patients are often excluded, and alveolar recruitment maneuver has never been studied~     independently.~      The investigators are conducting a randomized controlled prospective study to investigate the~     clinical value to achieve alveolar recruitment maneuver routinely in patients undergoing~     bariatric surgery.~      The objective is to show the reduction in dyspnea, oxygen dependency: reflection of~     atelectasis and the incidence of postoperative complications.~   "
74464|NCT02592213|"~     Breast cancer is the most common cancer type among women. Treatment in many cases involves~     axillary lymphadenectomy followed by radiation therapy. This increases the risk of lymphedema~     development which occurs in up to 30% of such cases. The present treatment paradigm is~     conservative with compression garments. There is a need for more effective treatment options~     and regenerative medicine offers hope for a change to a more curative approach. This Phase 2~     trial will examine the efficacy and safety of treatment with freshly isolated adipose-derived~     stromal cells administered as a cell-assisted lipotransfer to the affected axillary region.~   "
74465|NCT02592200|"~     The primary objective is to determine the change in frequency of complete spontaneous bowel~     movements (CSBMs) after 4 weeks of oral supplementation with Lactobacillus gasseri DSM 27123~     in healthy adult women with functional constipation.~   "
74466|NCT02592187|"~     Background: Mild Cognitive Impairment (MCI) is a risk factor for dementia and represents a~     critical window of opportunity to intervene and alter the trajectory of both cognitive and~     functional decline. Emerging life-logging technologies has shown a tremendous potential to~     increase autobiographical memory.~      Objective: The main goal of the present study is to develop a Cognitive Training program (CT)~     for MCI based on life-logging captured by a Wearable Camera (WeC) recording specific~     autobiographical episodes for stimulating posteriorly episodic memory. The challenge is to~     create an application to manage this large collection of images, which can be easily~     retrieved as events by users in a therapeutic context as a multimodal cognitive stimulation.~     The investigators will conduct the first pilot Randomized Controlled Trial (RCT) evaluating~     the effectiveness of the life-logging re-experiencing program immediately and 3-month~     follow-up period.~      Methodology: The Design is a single blind RCT of CT based on life-logging tools. 30 adults~     with MCI, after completion of two weeks image collection by a WeC, will be randomly allocated~     (1:1) into experimental or control group. Once acquire episodic individual's videos, all~     participants will attend 1-hour individual training sessions 2 times per week for 14 weeks.~     Main outcomes measures will be cognitive, functional, emotional and quality of life measures,~     as well as biochemical measures (BDNF).~      Expected results: The investigators expect the outcomes to provide preliminary evidence that~     autobiographical experimentation CT programs can positively impact cognitive functioning and~     may represent an effective strategy to improve memory and functionality in those who begun to~     experience cognitive decline.~   "
74467|NCT02592174|"~     The primary objective is to measure the prevalence of according to the Frascati~     classification in a HIV-infected population aged between 55 and 70 years (exposed group) and~     to compare it with the prevalence of HIV-Associated Neurocognitive Disorders (HAND) in~     unexposed subjects from the general population-based cohort CONSTANCES, matching subjects on~     age, gender, geographical origin and socioprofessional category.~   "
74468|NCT02592161|"~     A randomized, single center, double blind, parallel, placebo-controlled, clinical study of~     efficacy and safety of Chung A Won and placebo for 24 weeks three times a day on the~     improvement of osteoporosis and symptoms in Women's older than 50 patients with osteoporosis.~   "
74469|NCT02592148|"~     There is an interest to assess nutritional status of vitamins in humans in a non-invasive~     way, i.e. by avoiding taking blood samples. Saliva could potentially be an alternative to~     blood for this purpose. The suitability of saliva for status determination will be~     investigated by analysis of (forms of) vitamins A and E, B1, B2, B3, B6 and C in both saliva~     and blood.~   "
76216|NCT02569372|"~     This study is SAD(Single Ascending Dose)/MAD(Multiple Ascending Dose) study to Explore the~     Tolerability, Safety and Pharmacokinetics/Pharmacodynamics of GC1102 (Recombinant Hepatitis B~     Human Immunoglobulin) in Chronic Hepatitis B Patients.~   "
74471|NCT02592122|"~     In the patients with COPD mechanical ventilation, the bronchial dilatation is very common.~     However, the evaluation of the efficacy of the medical examination and other subjective~     indicators, such as doctors, depends on the doctor's experience; at present, there is no~     objective evaluation index. For patients with mechanical ventilation, the risk of cross~     infection can not only increase the risk of cross infection, but also increase the workload~     of clinical doctors and nurses. Therefore, this study proposes an objective evaluation method~     to evaluate the response of COPD patients to bronchial dilation. The hypothesis of this study~     can be used to guide the clinical medication through the test of the bronchus. If the~     patients with bronchial dilation test positive were used in the test, the patients were not~     used. In this evaluation method, the changes of airway resistance were measured by the~     accurate measurement of the patients with inhaled bronchial dilatation.~   "
74472|NCT02592109|"~     The epidemic of pediatric obesity has become a public health burden in both developed and~     developing countries, due to its serious health consequences, including an increased risk of~     type 2 Diabetes Mellitus and heart disease. Currently, dietary and exercise changes are still~     the center of preventive and treatment measures of obesity. Recently, the omega-3 group, one~     of the groups of polyunsaturated fatty acids (PUFAs), has been associated with many positive~     effects leading to the improvement of many diseases related to obesity. Nevertheless, the~     consumption of this essential nutrient requires certain ration to optimize its favorable~     result. Although previous studies have examined the efficacy of dietary counseling approach~     as treatment for obesity, none of them as explicitly explore the use of linear programming to~     create a tailored diet containing high omega-3 fatty acid food as a part of dietary~     counseling in obesity management program among children. Thus, this study is intended to~     contribute the clinical evidence regarding this area of knowledge, specifically the effects~     of enhanced counseling containing complementary feeding recommendation on nutritional status,~     omega-3 fatty acid, malondialdehyde, and alpha Tocopherol among children with risk of~     overweight aged 12 -23 months in East Jakarta.~   "
74473|NCT02592096|"~     To investigate the safety, tolerance, dynamic percolation model of single dose usage~     pazufloxacin mesilate ear drops for patients with acute suppurative otitis media or chronic~     suppurative otitis media~   "
74474|NCT02592083|"~     The purpose of this neoadjuvant trial is to evaluate efficacy and toxicity of the cdk 4/6~     inhibitor palbociclib when added to standard endocrine treatment. Initially, patients receive~     endocrine treatment for 4 weeks. In case of decrease of proliferation (Ki67) patients are~     then randomized between either continuous endocrine therapy (arm A) or the same treatment~     with addition of palbociclib (arm B). Patients with no change of proliferation are allocated~     to endocrine treatment + palbociclib without randomization (arm C). During the 12-weekly~     treatment period, clinical and radiological evaluations are performed repeatedly. Switch~     between the treatment arms A and B is allowed in case of lack of response or due to toxicity.~     A translational subprotocol is a mandatory part of the study protocol, except for use of~     PET-CT evaluations.~   "
74475|NCT02592070|"~     This study addresses an important public health concern; impoverished cognitive function~     associated with treatment of breast cancer. Due to increased awareness of breast cancer~     combined with advances in medical care, there are over 2.8 million women living with a~     history of breast cancer in the U.S. alone. Chemotherapy and adjuvant therapy to remove~     cancerous tissue can result in deficits in attention, speed of processing, memory, and~     quality of life. Physical activity has been associated with a number of health benefits for~     breast cancer survivors including improvements in cognitive function. However, most of the~     literature is cross-sectional and it is unclear whether acute (single) bouts of physical~     activity affect cognition and, if they do, how long this effect lasts. This study will be the~     first, to the investigators' knowledge, to examine the effects of an acute bout of aerobic~     exercise on cognitive functioning in breast cancer survivors. Specifically, the investigators~     will determine the effects of a 30-minute moderate intensity aerobic exercise session~     (treadmill walking) on immediate and one hour follow up changes in measures of processing~     speed, memory, and executive function. Additionally, accelerometer cut-points for physical~     activity intensities in breast cancer survivors will be assessed. Finally, the investigators~     will examine the association of cardiorespiratory fitness and physical activity with changes~     in cognitive function. Findings from this study will allow researchers to determine whether~     any acute effects of exercise on cognition are retained over time and therefore have real~     meaning in the context of one's daily life.~   "
74476|NCT02592057|"~     This study will evaluate the safety and efficacy of sofosbuvir (SOF)-based regimens~     administered as per the approved prescribing information in adults with chronic hepatitis C~     virus (HCV) infection treated in routine clinical practice in India.~   "
74477|NCT02592044|"~     The effect of aromatherapy with lavender essential oil on pain and anxiety during~     venipuncture will be evaluated.~   "
74478|NCT02592031|"~     Aim of this study is to demonstrate the bioequivalence of single subcutaneous doses of XM17~     and Gonal-f® in a confirmatory design. Furthermore, safety and tolerability will be assessed~     in human healthy female subjects. Only female subjects will be included in the study to reach~     the objectives of the study.~   "
74479|NCT02592018|"~     This is a single-arm, open-label study, which will examine the effect of secukinumab on the~     immunologic and genetic environment within psoriatic lesions.~   "
74490|NCT02591875|"~     The LEONARDO study is a non-randomized, multicenter, prospective study in which consecutive~     patients indicated for Atrial Flutter isthmus-dependent (AFL) ablation will be enrolled.~     Patients can be treated with any market released catheter for ablation. The decision to~     perform the ablation of AFL will be made based on clinical evaluation of the investigators~     according to their clinical practice. The study does not require specific surgical~     techniques. Patient time commitment for the study is approximately 12 months.The study has~     been designed to describe the italian clinical practice in relation to the approach of AFL~     ablation. In particular, the investigators will describe the methods for the validation of~     ablation success, the techniques adopted, and the patient management approaches in the~     participating centers.~   "
74491|NCT02591862|"~     Coversin in Paroxysmal Nocturnal Haemoglobinuria (PNH) in patients with resistance to~     Eculizumab due to complement C5 polymorphisms.~   "
87968|NCT02415647|"~     The purpose of this research is to study new ways of classifying mental disorders in children~     based on observable behavior and genetics to ultimately diagnose these disorders better.~   "
74480|NCT02592005|"~     Introduction: An emerging body of evidence indicates that there is an association between air~     pollution exposure in pregnancy and adverse pregnancy outcomes (Rudra, Williams, Sheppard ,~     Koenig, & Schiff, 2011; Dadvand, et al., 2013; Ritz, et al., 2014). Adverse pregnancy~     outcomes tend to lead to adverse neonatal outcome and a higher economic cost. Epidemiologic~     studies have also revealed that cardiovascular complications during pregnancy, such als~     preeclampsia, are associated with a greater cardiovascular risk during later life ( Abramson~     & Melvin, 2014).~      Aim: This study wants to examine the effects of exposure to environmental factors, polluents~     and particulate matter on the clinical pregnancy outcome for mother and child and to~     determine which biochemical changes in maternal, placental and cord blood best explain this~     effect.~      Methods: This study will be performed in a prospective cohort setup (n=200), recruited from~     the prenatal clinic in the University Hospital Antwerp. The data collection consists of four~     questionnaires (intake, both urine samples and postpartum), two blood samples (28 weeks and~     post-partum), two urine samples (20 and 30 weeks), two hair samples (20 weeks and~     post-partum), cord blood and the placenta.~      Results and conclusion: As the study will start in November 2014, no results are available~     yet.~   "
74481|NCT02591992|"~     To evaluate the safety and effectiveness of computed tomography angiography in the diagnostic~     and therapeutic cycle as the first-choice method of imaging in the diagnosis of patients with~     a high probability of stable coronary artery disease according to European Society of~     Cardiology recommendations.~   "
74482|NCT02591979|"~     The purpose of this study is to develop and validate a work-model in Primary Health Care for~     identifying patients with Sleep Apnea Syndrome, based on clinical variables and an ambulatory~     monitoring study.~   "
74483|NCT02591966|"~     The purpose of this study is to investigate effects of systemic treatments on genomic~     profiles in patients with breast cancer and to compare genomic profiling between~     premenopausal and postmenopausal women by systemic treatments in breast cancer.~   "
74484|NCT02591953|"~     Using randomization, prospectively determine superiority of either ultrasound-guided or~     landmark-guided biceps corticosteroid injections with regard to various clinical variables.~   "
74485|NCT02591940|"~     CARDIOPROOF is a proof-of-concept project that consolidates the outcomes of previous virtual~     physiological human (VPH) projects and checks the applicability and effectiveness of~     available predictive modelling and simulation tools, validating them in interrelated clinical~     trials conducted in three European centres of excellence in cardiac treatment (from Germany,~     Italy and the UK). CARDIOPROOF focuses on patients with aortic valve disease and aortic~     coarctation, which, if left untreated, can ensue irreversible heart failure. As a result~     treatment becomes mandatory, but optimum timing and the best type of treatment still remain~     difficult to determine. With more than 50.000 interventions per year within the EU, the~     diseases addressed by CARDIOPROOF have a significant socio-economic impact. Present clinical~     guidelines are highly complex and rely mostly on imaging diagnostics and clinical parameters,~     without benefiting, as yet, from patient-specific disease modelling based prediction.~     CARDIOPROOF goes beyond the current state of the art by conducting validation trials aimed at~     covering and comparing the complete spectrum of cardiovascular treatment, predicting the~     evolution of the disease and the immediate and mid-term outcome of treatment. Operational~     clustering is going to provide a seamless clinical solution that applies different modeling~     methods to realize the potential of personalised medicine taking into account~     user-friendliness as a key component of clinical usability. CARDIOPROOF's goal is to provide~     first-hand data on comparative cost-effectiveness and clinical efficacy of the most advanced~     VPH approaches compared to conventional diagnostics and treatment algorithms, thus~     accelerating the deployment of VPH methods in clinical environments, and bring to maturity~     holistic patient-specific computer-based predictive models and simulations.~   "
74486|NCT02591927|"~     The purpose of this study is:~        1. to assess whether pre-hospital glucose-insulin-potassium (GIK) administration in acute~          STEMI patients would reduce infarct size and ischemia/reperfusion damage using~          comprehensive tissue characterization by cardiovascular magnetic resonance (CMR) at an~          early post-infarction phase.~        2. to explore the putative cardioprotective mechanisms of pre-hospital GIK administration~   "
74487|NCT02591914|"~     The objectives of this study are to establish the safety and tolerability of intravitreous~     administration of altering regimens of Fovista™ (Anti-PDGF-B pegylated aptamer) administered~     in combination with Anti-VEGF therapy (Lucentis®, Avastin® or Eylea®) in subjects with~     subfoveal neovascular age-related macular degeneration.~      Subjects will be treated with Fovista™ and Anti-VEGF therapy every month for the first three~     months. Retreatment with Fovista™ and Anti-VEGF will occur if the following findings are~     present PER INVESTIGATOR DISCRETION:~        -  ≥ 5 ETDRS letters loss OR;~        -  Significant hemorrhage OR;~        -  New or increased RPE elevation consistent with increased disease activity OR;~        -  Increased neovascular lesion size OR;~        -  New or increased foveal intraretinal fluid~      If anti-VEGF re-treatment is not administered based on the re-treatment criteria noted above,~     Fovista™ anti-PDGF therapy MUST be administered at a minimum of every 3 months (as~     monotherapy).~      Therefore, subjects will be treated with Fovista™ or Anti-VEGF therapy for a total of 3-24~     administrations.~   "
74488|NCT02591901|"~     Due to the damage caused to the spinal cord, patients with spinal cord injury, cauda equina~     syndrome, multiple sclerosis and transverse myelitis may encounter loss of bladder function,~     which in turn can lead to a debilitating and costly complication: Urinary Tract Infections~     (UTIs). Given that these patients with loss of bladder function do not normally feel symptoms~     like pain - as would be the case in otherwise healthy persons - there is no clear agreement~     among experts on which signs and symptoms are indicative of a UTI. Although strong evidence~     is lacking, antibiotics have been widely used for prevention of recurrent UTIs in patients~     with loss of bladder function. However, this approach is now being questioned as antibiotic~     resistance has become a world-wide health concern. Policy makers recently stressed the~     importance of research into alternative preventative treatments. The use of vaccines is one~     such an alternative approach, which works by stimulating the body's immune system. One of~     these vaccines is a Uro-Vaxom® oral capsule which consists of inactivated traces of the~     bacteria that normally cause at least 83% of UTIs in patients with loss of bladder function.~     Previous studies show that Uro-Vaxom® resulted in a significant reduction of UTIs in~     otherwise healthy patients, as well as being safe to use. Before investigating the effects of~     this promising new vaccine, this proposed study aims to clarify two crucial issues. First,~     after reviewing the literature and appraising patients', carers' and healthcare~     professionals' experiences, the aim is to reach an agreement on how to measure a symptomatic~     UTI in patients with loss of bladder function that results from a spinal cord lesion. Second,~     using Uro-Vaxom® Investigators aim to conduct a smallscale, placebo-controlled trial with 48~     participants to investigate the feasibility of carrying out a larger trial on prevention of~     symptomatic UTI in such patients.~   "
74489|NCT02591888|"~     Liposomal bupivacaine or placebo will be administered at the end of a transobturator~     midurethral sling to determine if there is a difference in a patient's perceived~     postoperative pain.~   "
74840|NCT02587325|"~     mTOR activation has been shown to be relevant in the development and progression of pulmonary~     hypertension. Inhibition of mTOR has been shown to reverse or regress pulmonary hypertension~     in animal models. ABI-009 is an albumin-bound mTOR inhibitor with improved penetration in~     lung tissue.~   "
74492|NCT02591849|"~     Post-transplantation diabetes mellitus (PTDM) develops in 10-15 % of all renal transplant~     recipients within 10 weeks after transplantation, and has been associated with increased risk~     of cardiovascular disease and impaired patient survival. PTDM is primarily believed to be a~     variant of type 2 diabetes mellitus (T2DM), but the pathophysiology underlying the impaired~     glucose metabolism in renal transplant recipients with PTDM is unclear and some aspects are~     still poorly investigated. Hyperglycemic clamp investigations with concomitant infusion of~     glucagon-like peptide-1 (GLP-1) are warranted for a thorough characterization of the α-cell~     and β-cell function.~      The primary objective of the present study is to investigate whether hyperglucagonemia is~     present in renal transplant recipients with PTDM. Furthermore, the investigators aim to~     examine the insulinotropic and glucagon suppressive effects of GLP-1 (compared to placebo) in~     PTDM patients during fasting glycemia and during hyperglycemic conditions (hyperglycemic~     clamp), respectively.~   "
74493|NCT02591836|"~     The primary purpose of this placebo-controlled study is to evaluate the low‐density~     lipoprotein cholesterol (LDL‐C) efficacy and dose‐response of gemcabene 300, 600 and 900~     mg/day administered as monotherapy or in combination with atorvastatin 10, 40, and 80 mg/day~     to hypercholesterolemic patients.~      Secondary purposes include evaluating the effects of high‐sensitivity C-reactive protein~     (hsCRP), high‐density lipoprotein cholesterol (HDL‐C), triglycerides (TG) and apolipoprotein~     B (ApoB), and safety and efficacy of gemcabene monotherapy and gemcabene/atorvastatin~     combination.~   "
74494|NCT02591823|"~     Low dose methotrexate used in rheumatoid arthritis is considered very safe and has a side~     effect profile very different from that seen with high dose methotrexate used in oncology.~     Hair fall has been found to occur in high dose methotrexate but there is no data regarding~     the same when methotrexate is used in low dose.Thus this observational case control study is~     being undertaken to determine whether rheumatoid arthritis patients really need to be~     concerned about hair fall when on low dose methotrexate.~   "
74495|NCT02591810|"~     This prospective randomized control trial (PRCT) aims to compare the outcome of three~     treatments for acute distal radioulnar joint (DRUJ) injury with instability with or without~     concomitant distal radius fractures: serial splinting/casting with the hand and wrist in the~     most stable position for DRUJ reduction vs percutaneous DRUJ fixation with Kirschner wires vs~     open anatomic foveal repair of Triangular fibrocartilage complex (TFCC ) ligaments.~   "
74496|NCT02591797|"~     This will be a randomized, controlled, parallel-group clinical trial. The aim of this studio~     will be to evaluate the effectiveness of Hands/Eyes/mouth behavior management technique~     versus a conventional technique (covering the patient´s vision) during an inferior alveolar~     and lingual nerve block in preschool children referred for treatment at the School of~     Dentistry, Cardenal Herrera CEU University (Valencia, Spain). The sample will consist of 52~     children from 3 years old to 5 years 11 months old who need dental pulp treatment and/or~     tooth extraction of primary molars. Preschool children with no history of allergies to~     Lidocaine or systemic/neurological diseases and who did not take local anesthesia before the~     study will be include in this research.~   "
74497|NCT02591784|"~     Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located~     in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical~     efficacy has been shown in adult with head and neck cancer. The phase II study assessed the~     efficacy and safety of the combination of Nimotuzumab administered concomitantly with~     radiotherapy in patients with esophageal cancer tumours.~   "
74498|NCT02591771|"~     The purpose of this study is to evaluate efficacy and safety of i.v. adrenaline infusion as~     an early and fast haemodynamic stabilizer, associated with a tight tissue perfusion~     monitoring, in the context of a stepwise progression in the treatment of cardiogenic shock,~     including ventricular mechanical support.~   "
74499|NCT02591758|"~     The first and foremost manifestation of ischemic heart disease (IHD) is angina. At a global~     level, patients with chronic angina are at risk of poor vital status and deconditioning.~     Medical therapy and coronary revascularization using coronary artery bypass graft (CABG) or~     percutaneous coronary intervention (PCI) can effectively relieve angina . In spite of all the~     available treatment options, the assessment of angina remains a challenge. Angina has a~     cyclical pattern and will naturally worsen and improve as days go by. Likewise, angina can be~     significantly biased by the placebo effect. Clinically angina is most frequently quantified~     with the Canadian Cardiovascular Society (CCS) classes system. In research protocols, angina~     is often quantified with health-related quality of life questionnaires and diaries. None of~     the tool available accounts for an important phenomenon called ischemic threshold adaptation,~     which could be defined as a limitation of their activity level under the ischemic level,~     which will translate into fewer angina episodes and a seemingly stable condition. Better~     clinical assessment tools that take into consideration the ischemic threshold adaption are~     needed.~      Despite increased interest in wearable biometrics clothing in medicine, no prospective study~     has documented their utility to assess angina and to monitor the rehabilitation in cardiac~     patients. The Hexoskin™ is a biometric vest that can collect physiological data from~     individuals in their natural daily living environment. Currently, the use of biometric~     clothing is confined to a niche exploited exclusively by health enthusiasts, athletes or~     astronauts. As we enter this new age of virtual healthcare, tools like wearable biometrics~     could represent a giant leap forward in assisting healthcare professionals and patients. This~     will translate a better assessment of their health status, will allow physicians to target~     the right treatment strategy, ultimately improving case-selection and outcomes.~      Our objective is to prospectively validate the wearable biometrics clothing Hexoskin™ against~     established standards used to assess chronic stable angina. In addition, the investigators~     want to derive a novel vitality index from the data generated by this device that will~     subsequently be used to propose a new angina classification system that will account for~     ischemic threshold adaptation. Moreover, the investigators want to evaluate the safety and~     efficacy of Hexoskin monitor patients undergoing home-based cardiac rehabilitation.~   "
74500|NCT02591745|"~     This registry aims to gather anesthetic medications administered to fetuses directly as well~     as those administered via the mother during fetal intervention procedures. The goal is to~     assesss short and medium term outcomes as well as long term outcomes of these babies whao~     have received medication in utero. The long term outcomes will include but are not limited to~     neurodevelopmental outcomes.~   "
74501|NCT02591732|"~     The purpose of this study is to describe the characteristics of patients treated with~     different OATs and whether these characteristics differ between treatments.~      Furthermore to describe persistence to each OAT and risk of bleeding after initiating each~     OAT.~   "
74502|NCT02591719|"~     The aim of this study is to assess the safety and clinical efficacy of repetitive~     transcranial magnetic stimulation (rTMS) based on hemodynamic brain activity pattern with~     functional near infrared spectroscopy (fNIRS) in early poststroke nonfluent aphasia patients.~   "
76375|NCT02567292|"~     This study aims to identify whether an exclusive human milk diet (EHMD) would improve~     outcomes in neonates with congenital gastrointestinal disorders (CGD) and by facilitating an~     earlier transition off of parenteral nutrition (PN).~   "
74503|NCT02591706|"~     Primary Endpoints : The implant survival and success rate of V3 and C1 implants will be~     compared. Implant success rate will be evaluated by measuring the peri-implant bone~     remodeling from baseline to 1 year post insertion.~      The hypothesis is those implant survival rates of the test (V3) and control group (C1) are~     similar and that test V3 implant allows less peri-implant bone loss.~      Secondary Endpoints : The thickness of hard tissue in the buccal aspect of the V3 and C1~     implants will be compared. The bone thickness will be measured in cone beam computerized~     tomography (CBCT) on the day of implantation, 4 and at one year after the final restoration.~      The hypothesis is that V3 implant allows thicker bone dimension in the cervical area.~   "
74504|NCT02591693|"~     The purpose of this study is to determine whether a training intervention to improve~     caregiver confidence for family caregivers of patients with palliative care needs at home, is~     acceptable to patients and their caregivers.~   "
74505|NCT02591680|"~     Assess pain, function, hip and knee strength and kinematics of trunk and lower limbs during~     ascent and descent stairs after the addition of neuromuscular training to hip muscle~     strengthening.~   "
74506|NCT02591667|"~     There is a paucity of data on the histopathological response of peritoneal tumor deposits~     from colorectal cancer to neoadjuvant chemotherapy. Particularly, no prospective assessment~     of chemotherapy-associated histopathological response within the peritoneum has been~     performed so far. Therefore, there is an urgent need to conduct a clinical trial aimed at~     prospectively assessing the histopathological response within the peritoneum in patients with~     peritoneal metastasis from colorectal cancer.~      Recently, Loupakis et al. reported that the triplet regimen of 5-fluorouracil, oxaliplatin~     and irinotecan (FOLFOXIRI) in combination with bevacizumab significantly improved median~     progression-free survival in metastatic colorectal cancer patients from 9.7 to 12.1 months as~     compared with fluorouracil, leucovorin, and irinotecan (FOLFIRI) + bevacizumab. In view of~     these data, it is likely that FOLFOXIRI + bevacizumab will also lead to a significant~     improvement of the histopathological response within the peritoneum of patients with~     peritoneal metastasis from colorectal cancer (pcCRC) as compared with previous standard~     chemotherapy.~      The investigators hypothesize that FOLFOXIRI + bevacizumab will induce a pCR or major~     response in peritoneal tumor deposits in >30% of patients (taking the response rate to~     FOLFOX- or FOLFIRI-based neoadjuvant chemotherapy from the published literature as a~     reference).~   "
74507|NCT02591654|"~     The purpose of this study is to test two imaging techniques, one called whole body (WB)~     diffusion weighted (DWI) magnetic resonance imaging (MRI) (WB-DWI MRI), and another called~     Fluorine-18 3'-deoxy-3'-fluorothymidine positron emission tomography (PET) (F-18-FLT PET).~     The goal is to see whether these imaging techniques would allow the study doctors to see~     changes in the size of a tumor earlier for patients with metastatic melanoma receiving~     Pembrolizumab (MK-3475).~   "
74508|NCT02591641|"~     The purpose of this study was to examine the effectiveness of a shear reduction surface on~     shear, pressure, and comfort used in pre-hospital ground transport.~   "
74509|NCT02591628|"~     This proposed pilot study will test methods and feasibility for a large pragmatic clinical~     trial comparing two inexpensive, first-line drugs for treating high blood pressure to~     determine if one is superior in preventing serious cardiovascular events and death. It will~     develop and test novel approaches to conducting trials that will be faster, less expensive,~     and more realistic by being embedded in a typical practice setting and using advanced health~     information technology.~   "
74510|NCT02591615|"~     This is a multicenter randomized phase II to determine if the administration of standard~     platinum-based chemotherapy before MK-3475 in with Chemotherapy naive stage IV Non-small Cell~     Lung Cancer (NSCLC) will improve the overall response rate (ORR) compared to MK-3475~     administered before chemotherapy. Patients will be given Pembrolizumab as maintenance up to 2~     years: Carboplatin and paclitaxel or pemetrexed every 3 weeks x 4 cycles followed by~     pembrolizumab every 3 weeks for up to 2 years. Pembrolizumab every 3 weeks x 4 cycles~     followed by carboplatin and paclitaxel or pemetrexed every 3 weeks x 4 cycles followed by~     pembrolizumab every 3 weeks for up to 2 years.~   "
74511|NCT02591602|"~     Transporting radiology to the patient's home is challenging. Preliminary experiences~     conducted in Turin (Italy) and Lund (Sweden) indicate that the coupling of simple,~     light-weight X-ray equipments with a Computed radiography or Digital Radiography systems~     could be effective for externalization of radiographic service.~      The image and examination quality has been proved to be the same than those performed with a~     stationary equipment and analysis on safety of radio-protection systems show a very low risk~     exposure for health staff as well as for the general population.~      Mobile radiography in nursing homes has shown to be technically feasible and the most~     beneficial results were that patients avoided unnecessary transport back and forth to the~     hospital; in both experiences the majority of patients could be treated locally.~      The key points of RADHOME project are two:~        1. The first one is to built a network model, with the aim to disseminate clinical use of~          domiciliary radiology.~        2. The second one is to demonstrate clinical efficiency and cost-effectiveness of~          domiciliary radiology.~   "
74512|NCT02591589|"~     This is a randomized, prospective controlled trial in patients undergoing cardiac surgery,~     specifically on-pump coronary artery bypass grafting, comparing level of administered oxygen~     and partial pressure of arterial oxygen in the operating room and its impact on a widely-used~     and validated neurocognitive score, the telephonic Montreal Cognitive Assessment (t-MoCA),~     throughout the hospital stay and at 1 month, 3 months, and 6 postoperatively. It is~     hypothesized that cardiac surgical patients who undergo normoxic conditions throughout the~     intraoperative period will have better neurocognitive function than those with maintenance of~     hyperoxia.~   "
74513|NCT02591576|"~     Diabetes is key risk factor for death following acute myocardial infarction. However, the~     long-term excess risk of death associated with diabetes following acute myocardial infarction~     not known. Investigators aimed to determine the long-term excess risk of death associated~     with diabetes among patients with ST-elevation myocardial infarction (STEMI) and non-STEMI~     (NSTEMI) after adjustment for multimorbidity, risk factors and cardiac treatments.~   "
74514|NCT02591563|"~     The purpose of this study is to assess the effectiveness of Prevnar 13 against pneumococcal~     acute otitis media.~   "
76415|NCT02566772|"~     The purpose of this trial is to investigate the safety and tolerability of TAS3681 and to~     find the maximum tolerated dose of TAS3681.~   "
74515|NCT02591550|"~     The aim of this study is described as follows,~        1. To establish a validated method to test cough reflex sensitivity conducted by transient~          receptor potential vanilloid 1(TRPV1).~        2. To observe the variance of cough reflex sensitivity conducted by transient receptor~          potential ankyrin 1(TRPA1) of chronic patients and the relationship between cough reflex~          sensitivity conducted by TRPA1 and conducted by TRPV1.~        3. To study the distribution of TRPA1 and TRPV1 channels and their relationship to cough~          reflex sensitivity.~   "
74516|NCT02591537|"~     Twelve acute wounds (6 on either side of the umbilicus) will be surgically created in the~     lower abdominal area. One side of the umbilicus will be randomized to Oxygenesys treatment~     arm and the other side will be receiving a standard Tegaderm treatment arm. Time to wound~     healing will be observed over 14 days.~   "
74517|NCT02591524|"~     A hot topic in lung transplantation is the treatment of persisting sinus disease/colonization~     in CF patients to prevent descending graft colonization and chronic allograft dysfunction.~     From 2012, the Hannover transplantation group has been using a conservative approach with~     topical nasal inhalation. It is now necessary to analyse the impact of the new approach on~     graft colonization, incidence of BOS, symptoms, QoL etc in comparison to a historical cohort.~     It is also important to establish which is the best among the different inhaled antibiotic~     regimens currently available.~   "
74518|NCT02591511|"~     The aim of this study is to establish PAtient-Centered Computerized Educating System for~     Stroke (PACCESS) for patients with different demands and lack of knowledge.Those in the~     intervention group will receive the PACCESS and the control groups will receive traditional~     health education to test the effects of PACCESS in increasing clinical decision-making,~     health behavior, activities of daily living and knowledge of stroke, and health care quality.~   "
74519|NCT02591498|"~     The purpose of this study is to investigate the effect of a neuroplasticity-based~     computerized cognitive training for people with schizophrenia in the Brazilian population.~   "
74520|NCT02591485|"~     The purpose of this study is to explore the efficacy of Attention Control Training in~     preventing the development of Post Traumatic Stress Disorder (PTSD), during the period near~     after a traumatic event and before PTSD is develop.~      Individuals who underwent a traumatic event in the past two weeks will be randomly assigned~     to either Attention Control Training (ACT), designed to normalize threat-related attention~     biases or a control conditions: a psych-education intervention, designed as an active placebo~     condition or a follow-up condition, without intervention at all.~      Outcome measures will be a diagnosed of PTSD and the level of severity of symptoms derived~     from the Clinician Administered PTSD Scale (CAPS-5), after 3 and 6 month since the traumatic~     event had occurred.~      The investigators expected to find lower ratios of PTSD symptoms in the ACT condition~     relative to the control conditions in which no symptomatic relief is expected.~   "
74521|NCT02591472|"~     Orthopedic trauma is an unforeseen life-changing event. Nearly 2.8 million Americans sustain~     traumatic orthopedic injuries such as major fractures or amputation each year. Injury is~     treated in the hospital by physicians who medically stabilize and reconstruct the patient.~     Upon completion of their hospital stay, patients are discharged to begin their reintegration~     back into home and community activities. Despite high surgical success and survivorship~     rates, these injuries often result in poor quality of life (QOL)-related outcomes in~     otherwise healthy people. Fifty to ninety percent of patients develop severe psychological~     distress such as post-traumatic stress syndrome, depression or anxiety. Patients are often~     not provided the comprehensive support care and resources that are necessary to cope~     successfully with psychological stress and reintegrate into purposeful living. This is a~     major problem because high distress levels predict poor physical function, use of pain~     medications and low QOL. Survivors often cannot return to work, have persistent pain and~     experience social isolation. Distress worsens the self-perceptions of functional gain and~     efficacy and decreases personal fulfillment. Lingering psychological distress contributes to~     the development of other health problems and rebuilding of life is negatively impacted. The~     lack of psychosocial support contributes to injury re-occurrence, injury recidivism,~     re-hospitalizations and longer hospitalization stays, and higher personal and societal health~     care costs.~      There is currently a lack of comparative efficacy research to determine which delivery~     approach produces greater improvements in the outcomes that are most desired by patients,~     specifically, functional QOL and emotional well-being. The proposed research will directly~     compare these delivery-of-care approaches and measure the patient-reported outcomes that are~     considered important to patients.~   "
74522|NCT02591459|"~     The objective of this work is to develop an application to run on a mobile device Android~     tablet that features visual routines for autistic children.~   "
74523|NCT02591446|"~     Autism Spectrum Disorder (ASD) is the most prevalent of the developmental disorders and their~     incidence is rising. However, the variability in the behavioral symptoms is large. In part~     for these reasons, the ASD clinical diagnosis is challenging and often is not made until 3-5~     years of age. Thus, there remains an unmet need for a valid and reliable marker which would~     facilitate ASD diagnosis early in life, enable efficient study of ASD risk factors, and~     eventually serve as a useful marker to inform the development of effective therapies and~     assess treatment response in future clinical trials. The specific brain based marker that~     investigators are currently evaluating is brain plasticity (the changes that occur in your~     brain through experience). Investigators measure brain plasticity using noninvasive brain~     stimulation including transcranial magnetic stimulation (TMS) combined with brain imaging,~     EEG, and behavioral outcome measures. Their work to date demonstrates the potential utility~     of these techniques in higher-functioning adolescents and adults with ASD, and pilot data~     support the feasibility and safety of applying the same measures to children and lower~     functioning individuals.~      In this study, investigators will evaluate the validity of this marker in low- and~     high-functioning adults with ASD, in low- and high-functioning children with ASD, and assess~     the reliability of this marker.~   "
74524|NCT02591433|"~     This pilot clinical trial studies how well the JeffQuit group therapy program works in~     enabling patients with a history of cancer to quit smoking. The JeffQuit program uses group~     therapy to provide psychological support and address the mental need for smoking, the habit~     or routine it creates, and the physical need for nicotine. It is not yet known how well the~     JeffQuit program will work in helping patients with a history of cancer to stop smoking.~   "
74525|NCT02591420|"~     This study will evaluate the safety and virologic effect of an experimental human monoclonal~     antibody (mAb), VRC-HIVMAB060-00-AB (VRC01), alone or in combination with antiretroviral~     therapy (ART), in adults during early acute HIV infection.~   "
74526|NCT02591407|"~     The primary outcome for this study is the Numeric Pain Score (NPS) for elective patients~     undergoing elective colorectal surgery that have been randomized to transversus abdominis~     plane block or epidural anesthesia for the management of perioperative pain in elective~     colorectal surgery.~   "
74528|NCT02591381|"~     The investigators propose a randomized non-blinded comparison of standard vs. transcorporal~     approach for placement of an artificial urinary sphincter in male patients with stress~     urinary incontinence after radiation and radical prostatectomy for prostate cancer. In the~     United States, the artificial urinary sphincter (AUS), manufactured by American Medical~     Systems, is the gold standard surgical treatment for stress urinary incontinence (SUI) in~     men. The cuff, which is the portion of the device that encircles and occludes the urethra, is~     typically placed directly around the urethra (i.e., standard placement). The cuff can erode~     into the urethra. Transcorporal placement has been introduced as a method to reduce the risk~     of erosion. Transcorporal placement involves tunneling the cuff through the erectile bodies~     so as to protect the dorsal aspect of the urethra. This approach has never been compared to~     standard placement in a randomized fashion. In the randomized trial, no additional procedures~     beyond the normal care protocol will be required of the patients. The investigators will~     conduct the study through an established, IRB-approved multi-institutional network of~     surgeons. Success will be assessed via objective and subjective methods; complications will~     be tallied in a standardized fashion. Outcomes will be measured at two years.~   "
74529|NCT02591368|"~     This prospective randomized trial aims to ascertain differences in outcome measures for the~     operative treatment of basilar thumb arthritis by comparing the two most common surgical~     treatments: LRTI and mini tightrope suspensionplasty. The Investigators will evaluate both~     subjective and objective data to determine if a particular surgical method offers more~     favorable outcomes.~   "
74530|NCT02591355|"~     Platelet rich plasma (PRP) therapy is a novel therapeutic modality that has seen broad~     applications for a number of medical indications including those in orthopedics, dentistry,~     and dermatology. In dermatology, its uses have included treatment of chronic wounds and~     facial rejuvenation. More recently, anecdotal reports have suggested some efficacy in the~     treatment of hair loss, but to the best of our knowledge, there has been only one published~     case series documenting its use for this indication.~   "
74531|NCT02591342|"~     Postoperative periprosthetic femoral fracture after hip arthroplasty is associated with~     considerable morbidity and mortality. Recent cohort studies have demonstrated a high~     incidence of PPF in elderly patients treated with two commonly used polished, tapered,~     collarless stems in elderly patients. The aim of this study was to compare the rate and~     characteristics of PPF in a consecutive cohort of patients treated either the polished~     tapered CTP stem or the matte anatomic SP2 stem in an elderly population above 80 years of~     age with femoral neck fracture.~   "
74532|NCT02591329|"~     The objective of this research is to test the effectiveness of persuasive messages targeted~     at parents who have children who consume inadequate amounts of calcium. Specifically, the~     effectiveness of the intervention material on increase a) the purchase of calcium-rich~     products by parents, and b) the consumption of calcium-rich products in the parent and child~     will be examined in 400 families across Canada. Families will receive either the targeted~     intervention materials or standard of care generic nutrition materials retrieved from Health~     Canada's website. Materials will be delivered to parents during weeks 0, 8, 16, and 22 of the~     study. Monitoring of parents' calcium product purchases and consumption behaviour in both~     parents and children will occur at week 0,12, 24 weeks (immediately post-intervention) and at~     52 weeks (i.e., 6-month follow-up). Purchases will be verified by grocery receipts made~     during the aforementioned weeks. Parents will self-report on their dietary consumption as~     well as their child's using a food frequency questionnaire. The study hypotheses are as~     follows:~        1. Parents in the experimental condition will purchase more calcium-rich products as~          compared to parents in the control condition.~        2. Parents and children in the experimental condition will consume more calcium rich~          products as compared to parents and children in the control condition.~        3. Perceived outcome expectancies of consuming calcium-rich products will increase to a~          greater extent in parents in the experimental condition as compared to parents in the~          control condition.~        4. Self-regulatory efficacy to consume calcium-rich products will increase to a greater~          extent in parents in the experimental condition as compared to parents in the control~          condition.~        5. Perceived social support and role modelling behaviour will be highest in parents in the~          experimental condition as compared to parents in the control condition.~        6. Self-regulatory efficacy and outcome expectancies will mediate the changes in~          calcium-rich product purchases and consumption.~   "
74533|NCT02591316|"~     The purpose of this study is to examine the relationship between nutrition, physical activity~     and brain function in breast cancer survivors.~   "
74534|NCT02591303|"~     Insomnia is characterized by rumination and worry over stressful events affecting nighttime~     sleep. Emotional reactions while stressful events are ongoing have not often been~     investigated in insomnia. In the current study stress reactions will be measured during a~     real-life simulation experiment with stressful events and investigate not only how previous~     sleep patterns affect emotional reactivity to the event but also how the emotional events~     affect sleep patterns the following night.~      Thirty-six female subjects (age 25-45 years) without sleep complaints (n=18) or with insomnia~     (n=18) will enroll in a interventional study measuring the reaction to and effects of either~     neutral or stressful events during driving. Through questionaires and intake polysomnography,~     clinical levels of depression and anxiety will be excluded as well as sleep medication use~     and alternative sleep disorders than insomnia. Stress levels will be measured through skin~     conductance and heart rate variability during events and through nighttime polysomnography~     (PSG). Effects on sleep architecture and arousal levels will be measured through nighttime~     PSG.~      Investigators hypothesize that subjects with insomnia, compared to subjects without sleep~     complaints, show stronger emotional reactions to stressful events and stronger effects of~     stress on sleep quality the following night. Results will facilitate a model for emotional~     reactivity in chronic sleep disruption which may aid to prevent short term sleep disruption~     converting into chronic insomnia and aid in developing customized insomnia treatment.~   "
74535|NCT02591290|"~     The aim of this study was to collect further information regarding an increase immune~     response of SP284 after an additional dose in Japanese participants.~      Primary Objective:~        -  To evaluate and describe the immune responses to meningococcal antigens (serogroups A,C,~          Y and W-135) at 28 days following each vaccination with SP284 vaccine in participants 20~          through 55 years of age.~      Other Pre-specified objective:~        -  To describe the safety in terms of immediate systemic adverse events (AEs), solicited~          reactions, unsolicited non-serious adverse events, and serious adverse events (SAEs)~          following receipt of each dose of SP284 vaccine in persons 20 through 55 years of age.~   "
74536|NCT02591277|"~     This study will evaluate the safety and efficacy of Harvoni® (ledipasvir/sofosbuvir (LDV/SOF)~     fixed-dose combination (FDC)) treatment under real world use in Japan. Among adult patients~     with chronic genotype 1 hepatitis C virus (HCV) infection and treated with Harvoni in routine~     clinical use, the primary objective of this study is to evaluate the incidence of adverse~     drug reactions (ADRs) under real world settings.~   "
74537|NCT02591264|"~     The aim of this study is to determine the role of human neutrophil peptide-1 to 3 in the~     occurrence of periprocedural myocardial infarction.~   "
74538|NCT02591251|"~     Laparoscopy is a minimally invasive method used for diagnostic and therapeutic purposes. It~     allows surgeons to take a look on the abdominal and pelvic organs. Diagnostic laparoscopy is~     usually done in an operating room under general anesthesia. The procedure takes about 25~     minutes and the patients usually discharged in the same day. The laparoscopy can diagnose~     pelvic pathological conditions in approximately 50% of the cases. However, the laparoscopy~     has some complications, such as infections, hemorrhage and injuries of visceral organs.~      A preoperative vaginal preparation is important to prevent the bacteria colonization in a~     trial to avoid postoperative infection after laparoscopic surgery. The povidone-iodine (PI)~     is normally used as a skin and vaginal disinfectant to prevent postoperative infections,~     however; it can be the cause of significant postoperative irritation.~      There are many reports in the literature proved that the mechanical cleansing of the vagina,~     not the use of an antiseptic solution, is responsible for the efficacy of vaginal~     preparations. In the field of assisted reproductive technology; A study in 1992 concluded~     that the infection rates with normal saline solution are comparable to PI.~      Another proved that, a normal saline solution can be effective in prevention of preventing~     postoperative infections after vaginal surgery.~      The most recent study by Lewis et al has been shown that the Baby shampoo is preferable than~     PI in vaginal cleansing before gynecologic procedures because it has minimal vaginal~     irritation and cheaper than PI.~      So the optimal vaginal antiseptic solution is unknown, the investigators want to conduct a~     randomized trial comparing 2 commonly used vaginal antiseptic solutions: PI and the saline~     solution before the laparoscopic surgery.~      The normal saline is used in medicine as an intravenous isotonic infusion and for cleaning~     wounds. It is a mild but effective cleaning agent and will not harm normal tissue, unlike~     many stronger antiseptics. It is available and inexpensive in comparison to povidone iodine.~   "
74539|NCT02591238|"~     The main purpose of this study was to evaluate the effects of melatonin in the regulation of~     the vascular injury in smokers through population-based, randomized, double-blind,~     placebo-controlled trial.~   "
74540|NCT02591225|"~     This is a single-center, randomized, two treatment groups, open, phase IV clinical study in~     subjects with atrial fibrillation and left atrial thrombus. At Visit 0 (Screening Visit)~     subjects with left atrial thrombus established in transesophageal echocardiography (TEE) are~     eligible to entry in the study. If the subjects fulfill all other in- and exclusion criteria~     and undersign the informed consent the baseline cranial magnet resonance imaging (MRI) can be~     performed followed by randomization to one of the two treatment groups (Phenprocoumon or~     Dabigatran) at Visit 1 (Baseline Visit). The subjects will be treated for 12 months with~     Phenprocoumon (INR adjusted once daily) or Dabigatran 150 mg twice daily. Routinely clinical~     follow up visits will be done at week 4, month 3, month 6, month 9 and month 12. Follow up~     TEE will be performed after 4 weeks and after 12 months also the follow up cranial MRI at~     this visit. If the subject was randomized in the VKA group routinely INR measurements will~     performed.~   "
74541|NCT02591212|"~     The purpose of this randomized intervention pilot is to evaluate the relative efficacy of~     bystander training elements (delivery mode and integration of substance abuse prevention)~     among cohorts of incoming undergraduates at the University of Kentucky, a nationally~     recognized leader in addressing sexual violence through bystander intervention programming.~     Per university policy, all incoming undergraduates will participate in mandatory online~     training covering sexual violence awareness, bystander concepts, and alcohol use/abuse.~     Consenting students will be randomized to one of the following training conditions:~        1. Green Dot Intensive Bystander Training (INT) or~        2. Student Wellness Training (active control). Students in each condition will be followed~          for 9 months, one academic year.~   "
74542|NCT02591199|"~     The purpose of this study is to determine if the combination product (URG101) is safe and~     effective versus its individual components (Heparin Sodium and Lidocaine Hydrochloride) for~     the treatment of Interstitial Cystitis/Bladder Pain Syndrome. The study is randomized and~     double-blinded such that neither the subject nor doctor will know which drug or placebo is~     received.~   "
74543|NCT02591186|"~     Experimental Approach: (1) Participants: Women (ages 21 to 42) who seek IVF treatment at the~     Center for Fertility & Reproductive Surgery will be eligible for the study. Seventy women~     will be recruited and randomly assigned to either the intervention (acupuncture plus standard~     care) or the comparison (standard care alone) group. (2) Intervention: Participants in the~     intervention group will receive 3 acupuncture sessions during the project with the first~     treatment between day 6-8 of the stimulated IVF cycle, second on the day of embryo transfer~     and the third one day post transfer. Participants in the comparison group will receive no~     intervention but will receive standard care. (3) Measures: The primary outcome measures~     include prostacyclin and thromboxane vasoactive biomarkers. Secondary outcome measures~     include perceived stress levels. (4) Procedure: Upon IRB approval, an informed consent will~     be provided to all participants. Pre- and post- acupuncture urinary metabolites of~     prostacyclin and thromboxane will be assessed. A standardized Perceived Stress Scale will be~     administered before and after each acupuncture session for the study group, and before and~     after a 30-40-minute waiting period for the control group.~   "
74544|NCT02591173|"~     Pharmacologic approaches to increase levels or actions of the vasodilatory peptide~     angiotensin-(1-7) are currently in development for the treatment of hypertension based on~     findings from animal models. There are limited and contradictory clinical studies, however,~     and it is not clear if this peptide regulates blood pressure in humans. The purpose of this~     study is to better understand the cardiovascular effects angiotensin-(1-7) in human~     hypertension, and to examine interactions of this peptide with the autonomic nervous system.~     The investigators propose that the difficulties in showing angiotensin-(1-7) cardiovascular~     effects in previous clinical studies relates to the buffering capacity of the baroreceptor~     reflex to prevent changes in blood pressure. Autonomic failure provides the ideal patient~     population to test this hypothesis. These patients have loss of baroreflex buffering and have~     low levels of angiotensin-(1-7) in blood. The investigators will test if angiotensin-(1-7)~     infusion can lower blood pressure in patients with autonomic failure, and will determine the~     hemodynamic and hormonal mechanisms involved in this effect.~   "
74545|NCT02591160|"~     Primary hyperparathyroidism (PHPT) is the most common cause of hypercalcemia in the~     ambulatory setting. PHPT may be cured with surgery and indications for intervention have been~     defined and include urinary calcium/creatinine clearance. Hydrochlorothiazide (HCTZ), the~     most commonly prescribed medication for hypertension, reduces urinary calcium excretion and~     confounds urinary testing. As a result, it is universally recommended that thiazide diuretics~     be stopped in advance of urinary testing. To date, no studies are available to provide~     evidence-based guidance as to how long HCTZ must be held for urinary calcium excretion to~     return to steady state in PHPT. The objective of this study is to serially calculate urinary~     calcium/creatinine clearance ration in patients with suspected PHPT while holding HCTZ to~     determine the minimum duration of medication cessation necessary for urinary calcium~     clearance to reach steady state.~   "
74546|NCT02591147|"~     This pilot trial is randomized, double-blind, and placebo-controlled trial with two parallel~     arms: an intervention group using silver diamine fluoride (SDF) and a placebo group~     (control). 144 eligible healthy adults will be enrolled in the study and randomly assigned to~     one of the two treatment groups. Both groups will receive the traditional preventive measures~     including cleanings, Fluoride varnish, diet analysis and counseling. Study participants will~     be followed for two years and caries progression will be radiographically monitored.~   "
74547|NCT02591134|"~     The effects of non-nutritive sweetened (NNS) beverages on weight management and psychological~     indices of appetitive behaviour have not been assessed in both weight loss and maintained~     weight loss phases over the long term to determine whether NNS beverages may assist in~     efforts to lose weight and maintain weight loss and how this affects appetite expression~     (satiety, food choice, craving, ease of dieting etc.). Thus the present research will~     determine the impact of NNS beverages as compared to water on weight loss and weight loss~     maintenance, satiation, satiety, cravings for sweet, exercise efforts and mood state across~     both a period of weight-loss as well as a weight-maintenance phase. To determine if the~     effects of NNS on appetite are beneficial or detrimental to successful weight management, the~     study will also systematically compare the effects of NNS beverages, water and caloric~     beverages (CBs) on appetite (hunger, satiety, liking and wanting) and energy intake~     (including food choice and caloric compensation) across the whole day during active weight~     management in a subset of participants.~   "
74548|NCT02591121|"~     Prospective, single-centre study in healthy volunteers to establish a reference range for the~     RAMP Procalcitonin (PCT) test. The primary objective of this study is to establish the~     reference range for measurement of PCT levels using the RAMP Procalcitonin test.~   "
74549|NCT02591108|"~     The assessment of neuromuscular blockage is common practice in the operating room, in which~     such agents are employed. Still today, the use of simple hand held stimulators and visual~     monitoring of these responses are the norm. The investigators want to study the potential for~     employing a non‐invasive quantitative device with built in sensors that will hopefully~     accurately determine the degree of neuromuscular blockade. This system utilizes commonly~     employed train of four (TOF) electrical stimulation pulses, an incorporated force sensor and~     an automated detection system. This system will not only utilized pre‐blockade, but also~     throughout an entire surgical procedure and during reversal therapy. For comparisons, the~     investigators will use both the prototype device and a standard hand held TOF for the~     assessment of neuromuscular blockage. In other words, the planned protocol will involve~     testing the effectiveness and accuracy of the device concurrently with peripheral nerve~     stimulation, during a procedure as is done for the current standard of care. All protocols~     will be carried out under the direct guidance and supervision of anesthesiologists and/or~     nurse anesthetists.~   "
74550|NCT02591095|"~     ABT-263 as single agent in women with platinum resistant/refractory recurrent ovarian cancer.~   "
74551|NCT02591082|"~     This is an observational study to assess patient survival and clinical outcomes after the~     RenovoCath™ RC120 catheter is used to deliver chemotherapeutic agents to pancreatic tumors.~   "
74552|NCT02591069|"~     Minimally Conscious (MCS) or Vegetative State (VS) are disorders of consciousness which often~     occur following traumatic brain injury or ischemia. These alterations result most of the time~     in patients' loss of autonomy and require long years of special care. No efficient therapy to~     improve patients' consciousness has been found so far. Investigators propose to use vagal~     nerve stimulation (VNS) to restore cortical activity and patients' embodied self. The~     investigators' main hypothesis is that VNS will reestablish the thalamo-cortical connectivity~     leading to an improvement of the consciousness state. To test this hypothesis, investigators~     will use behavioral measures as well as fMRI, PET scan and EEG to assess brain activity.~     Patients will be evaluated before and during eight months following implantation of the~     stimulation device.~   "
74553|NCT02591056|"~     The purpose of this study is to determine whether low level laser light therapy applied using~     the Erchonia Verju Laser combined with manual lymph drainage applied using the Iskra Medical~     Green PRESS 8 Lymph Drainage System is effective in reducing the circumference of the waist,~     hips and upper abdomen.~   "
74554|NCT02591043|"~     Since May 2010 the Department of Trauma, Basel University Hospital has performed surgical~     stabilisation of the posterior pelvic ring on 55 patients. These patients have not received a~     structured follow up examination or evaluation of outcome after surgery.~   "
74555|NCT02591030|"~     Bile duct tumours are rare. They are the 6th most common type of digestive cancer. Their~     therapeutic management is complex and must be multidisciplinary in nature. Most of the time,~     an endoscopic or radiological biliary drainage is necessary before any tumour treatment.~      Their prognosis is poor due to the fact that they are normally diagnosed late, which makes~     curative surgery impossible. A population study in the Côte d'Or region of France reported a~     survival rate at 5 years of approximately 10%.~      For the locally advanced or metastatic forms, treatment has not been properly codified. With~     respect to chemotherapy, prospective studies, most often phase II, are difficult to interpret~     due to a limited number of patients and due to the heterogeneity of this type of tumour (bile~     duct and pancreas tumours). Treatment with 5FU alone provides an objective response in~     approximately 10% of cases. In combination with mitomycin or carboplatin, the objective~     response rate is 20%, with a median survival period of 5 months. Interferon combined with 5FU~     has a better response rate (30%), but occurrences of different types of toxicity are more~     frequent.~      More recently, gemcitabine and the 5FU-cisplatin combinations demonstrated objective tumour~     control in 50% of patients with a median survival period of 10 months. Gemcitabine combined~     with oxiplatin or with cisplatin has shown the same response rate but a median survival~     period of approximately 12 months.~      The benefit of this combination has been confirmed in a phase III trial that compared the~     gemcitabine-cisplatin combination to gemcitabine alone, in 410 patients with locally advanced~     unresectable and/or metastatic bile duct cancer. The results were in favour of the combined~     treatment with a median survival period of 11.7 months (versus 8.1 months - HR 0.64 [0.52 -~     0.80]). This combination is currently the reference first-line treatment.~   "
74556|NCT02591017|"~     34 adult (>18 years) cancer pain outpatients with Opioid base therapy because of pain and~     breakthrough pain or extreme pain on movement will be included in this prospective,~     randomized, double-blind crossover study.~      Over a period of 3 weeks patients will go through 3 treatment arms, each one lasting one~     week: Group A receives morphine drops and Placebo spray, Group B receives ketamine/chitosan~     spray nasal and Placebo drops and Group C receives morphine drops and ketamine/chitosan spray~     nasal.~      Primary endpoint is time to onset of action of intranasal ketamine compared with morphine~     drops. Secondary endpoint is the median numeric rating scale (NRS) improvement after using~     the spray or morphine or the combination of ketamine spray and morphine drops.~   "
76416|NCT02566759|"~     The purpose of this study is to determine the safety, tolerability and pharmacokinetics (PK)~     of single and multiple rising doses of TAK-831 in healthy participants.~   "
74557|NCT02591004|"~     The aim of this study is to investigate the possible use of calcium channel as a~     neuroprotectant in cases with PTL. This will be done by comparing the effect they have on~     cerebral blood vessels with the already established MgSo4. They have been proven superior to~     magnesium sulphate in tocolysis, and they possess the mechanism of action that would allow~     for their theoretical use as neuroprotective agents.~   "
74558|NCT02590991|"~     This study investigate the long term effect of supplementation of pre- and probiotics in~     early life in children born by Caesarean Section.~   "
74559|NCT02590978|"~     Randomized controlled trial to demonstrate the safety of early cholecystectomy (<72h) in~     patients with mild gallstone pancreatitis. The purpose of this study is to demonstrate that~     there is a shorter hospital stay and no higher complication rates.~   "
74560|NCT02590965|"~     This is a randomized, double-blind, placebo-controlled, multi-center Phase II clinical trial~     to evaluate the efficacy and safety of Fruquintinib plus best supportive care in patients~     with advanced non-squamous non-small cell lung cancer who failed to second-line standard~     chemotherapy.~   "
74561|NCT02590952|"~     Epitinib (HMPL-813) is a selective EGFR tyrosine kinase inhibitor. Epitinib has demonstrated~     strong inhibitory effects on multiple tumors with overexpressed EGFR or sensitive EGFR~     mutations in pre-clinical setting. This first-in-human study is conducted to assess the~     maximum tolerated dose (MTD) and dose-limiting toxicity(DLT), safety and tolerability,~     pharmacokinetics (PK), and preliminary anti-tumor activity of Epitinib.~   "
74562|NCT02590939|"~     The main objective of this study is to assess the efficacy of the Cefaly® device as an acute~     treatment of migraine attack in adult patients. The patients will be applied either an active~     or placebo external neurostimulation for 1 hour during a migraine attack, and will report the~     pain on a visual analog scale before and after the treatment.~   "
74563|NCT02590926|"~     Fractional Flow Reserve (FFR) has recently emerged and has been largely validated as a safe~     and efficacious way of ischemia testing for patients with stable angina. The new recently ESC~     guidelines have strongly suggested a FFR based approach for patients with stable angina, also~     for those with challenging lesions like left main disease, severe multivessel stenosis for~     heart failure patients and those with single remaining vessels although left main disease and~     an ejection fraction less than 30% are exclusion criteria of the randomized controlled trials~     on this topic. Consequently the investigators performed a prospective multicenter study to~     understand the safety and efficacy of a FFR based approach for these patients.~   "
74564|NCT02590913|"~     The purpose of this study is to investigate the metabolic and endocrine responses during 3~     hour after taking 75g fructose or glucose in young Chinese.~   "
74565|NCT02590900|"~     Compared to early postpartum (10-15 weeks) observations, paracetamol clearance was~     significantly higher (21.1 vs 11.7 l.h-1, + 80 %) at delivery. This higher clearance was due~     to a disproportional increase in glucuronidation (11.6 vs 4.76 l.h-1, + 144 %), a~     proportional increase in oxidation clearance (4.95 vs 2.77 l.h-1, 78 %) and primary renal~     clearance (1.15 vs 0.75 l.h-1, 53 %) [KUlo et al, Int J Obstet Anesth]. This increase in~     glucuronidation clearance may in part be driven by oestradiol, and may explain within and~     between individual differences in paracetamol metabolism (e.g. oral contraceptives,~     follicular vs luteal phase, postpartum, pregnancy, or duration of pregnancy) in young women.~      Based on a pooled analysis, investigators aimed to further explore the impact of these~     covariates on paracetamol metabolism based on plasma and urine collections in women at~     delivery, in postpartum (early, or late) and healthy volunteers, either or not on oral~     contraceptives (OC) following intravenous (iv) paracetamol administration.~   "
74566|NCT02590887|"~     The purpose of this study is to determine the health effects of the 4 weeks intake of a drink~     manufactured from lupine protein hydrolysates in healthy volunteers. For that, blood markers~     of inflammation, oxidative stress, carbohydrate, lipid, protein and liver metabolism,~     together with general hematology and blood coagulation will be assessed at baseline time (day~     0) and after (day +14, +28 and +42) drink ingestion.~   "
74567|NCT02590874|"~     The purpose of this study is to determine whether Cymbalta (duloxetine) is effective to~     improve cognition in individuals with Mild Cognitive Impairment.~   "
74568|NCT02590861|"~     Distal extension Partial Removable Dental Prostheses (PRDPs) are less stable than tooth~     supported PRDPs due to progressive resorption of the alveolar ridge, which alters the~     retention and support generated by alveolar bone height. In addition, long-term wearers~     suffer with progressive alveolar ridge resorption that contributes to greater instability.~     The loss of stability and retention under the PRDP can lead to difficulties during~     mastication and swallowing, because of movement of the partial denture. These difficulties~     force patients to self-select food substances that are softer and easier to chew and possibly~     create changes in social eating. Therefore, having a partial denture that is poorly retentive~     will impact their oral health related quality of life Oral Health Related Quality of Life~     (OHRQoL). The placement of a dental implant into the edentulous area will transform a~     conventional PRDP into an Implant Supported PRDP, which will improve the functional capacity~     of partial denture wearers, especially their ability to comminute harder food substances such~     as fruits and nuts. The purpose of this study is to quantitatively measure the functional~     differences of patients wearing conventional PRDP with patients wearing implant supported~     PRDPs and Oral Health Impact of patients wearing implant supported PRDPs. The hypothesis is~     that patient wearing implant supported PRDPs will have greater functional capacity than~     patients wearing conventional PRDPs.~   "
74579|NCT02590718|"~     The study is carried out in a prospectively randomly controlled way. In the context of~     acknowledgement and understanding from parents, by comparing with traditional process (lying~     without the pillow and fasting water and food for four hours following lumbar puncture), an~     optimized postoperative management (lying without the pillow for half an hour following~     lumbar puncture) is randomly selected. All children will be evaluated by the FLACC (The face,~     legs, activity, cry, consolability behavioral tool) scale to assess the degree of pain after~     lumbar puncture. Any postoperative condition will be recorded and analyzed. A questionaire~     about bad memory during lumbar puncture for all parents and children will be investigated in~     order to establish an optimized lumbar puncture management process.~   "
76729|NCT02562677|"~     This is a phase II, open-label clinical trial. This clinical trial has as primary objective~     to evaluate changes in EEG of a Trigeminal Nerve Stimulation (TNS) treatment protocol for~     elderly patients with moderate / severe depressive episode.~   "
74569|NCT02590848|"~     Background: Adolescence is an important period for brain development as a result of increased~     synaptic plasticity. Omega-3 polyunsaturated fatty acids (n-3 PUFAs) are essential nutrients~     for brain development and protection against oxidative stress. Walnuts have the highest n-3~     PUFA concentrations of all edible plants.~      Objective: The investigators hypothesize that walnut intake will increase n-3 PUFA~     availability in the body to a level that enhances the development of the brain during~     adolescence. The technicians will conduct a long-term (6 months) population-based randomized~     controlled trial in teenagers (n=400), and determine the effectiveness of the intervention~     (30 g of walnut kernels per day, ~1.5g of n-3 PUFA) in enhancing brain development.~      Methods: Fieldwork team will contact teenagers and families in collaboration with 20 high~     schools. Families will receive a basic guide on following a healthy diet in order to ensure~     implementation and adherence. Brain development outcomes will be measured at baseline and~     after the intervention. The use of computerized neuropsychological tests will provide the~     precision required to detect even subtle changes in brain development resulting from the~     nutritional intervention. Behavioral (socio-emotional) development will be assessed in order~     to cover a wider picture of brain development. Blood samples will be collected to measure n-3~     PUFA levels before and after the intervention in a randomized subsample from both groups~     (control/ intervention). Linear regression models adjusted for baseline neuropsychological~     scores will be used to analyze the intervention effect.~      Implications: The outcomes of this Project are expected to be a greater understanding of the~     role of n-3 PUFA intake (walnut) in brain development. A major goal in public health research~     is to develop cost-effective health recommendations to teenagers.~   "
74570|NCT02590835|"~     This study was designed as a randomized controlled clinical trial to compare conventional~     orthodontic treatment (control group) and piezocision-assisted orthodontic treatment (PS~     group). Twenty-four consecutive adult patients from the Orthodontics Department of Liege~     University Hospital, Belgium who met the inclusion criteria were enrolled from January to~     October of 2013.~   "
74571|NCT02590822|"~     There is an epidemic of type 2 diabetes in younger adults. These patients are at very high~     lifetime risk of heart-related complications. Subtle heart abnormalities can be present even~     at a young age in these patients and may predispose them to heart failure and ultimately~     premature death. There is emerging evidence that type 2 diabetes can be reversed with weight~     loss. We propose that weight loss can also reverse the fatty changes seen in the liver and~     heart in these patients, and in turn lead to improved heart function.~      This project aims to identify how type 2 diabetes causes changes in the heart in young people~     with type 2 diabetes by performing detailed scans and other tests of the heart's structure~     and function. In addition we will attempt to see if the heart's pumping function can be~     improved, either by a weight loss program with a special low calorie diet, or by a structured~     program of exercise. This will be compared with the usual standard diabetes care.~      As well as looking to see if the heart's function can be improved with the intervention, we~     also aim to identify what the mechanism of any improvement would be. We suspect that changes~     in the amount of fat within the liver and the heart may be responsible, and will measure~     these at the beginning, end and in some patients halfway through the study to explore~     possible mechanisms amongst other clinical variables (e.g. HbA1c)~   "
74572|NCT02590809|"~     Hypertrophic cardiomyopathy (HCM) is the most frequent genetic cardiac disease characterized~     by an asymmetric hypertrophic. In two third of patients, an obstruction to blood ejection is~     observed within the left ventricle which is named left ventricular outflow tract obstruction~     (LVOTO). This phenomenon can occur at rest or during exercise and is associated with symptoms~     such as dyspnea, dizziness or chest pain that can significantly limit day life adaptation. To~     now, medical or interventional treatments such as betablocacker, calcium blockers or septal~     alcoholisation or surgery present with a limited efficiency. Recent studies from~     investigators group revealed new concepts about the role of venous return to the LVOTO.~     Therefore the investigators hypothesis that BX1514M generating a venous vascular~     constriction, could improve symptoms of HCM patients by reducing LVOTO.~   "
74573|NCT02590796|"~     The study has two phases: Phase B and Phase C. The purpose of the Phase B study is to~     determine the performance (sensitivity and specificity) of a smartphone application (DelApp)~     to identify delirium in the whole inpatient sample. The study also aims to determine the~     performance (sensitivity and specificity) of the DelApp to discriminate between delirium~     (with or without dementia) and dementia (without delirium).~      The purpose of the Phase C study is to determine the efficacy of the DelApp software~     application in detecting delirium in unselected patients in an inpatient sample and to~     determine the performance of the DelApp to discriminate between delirium and dementia. The~     study also aims to explore the performance of the DelApp in tracking change in cognitive~     function.~   "
74574|NCT02590783|"~     Pelvic ring fractures in the elderly are associated with high morbidity during standard~     conservative treatment due to immobility. Furthermore the risk of long term dependence even~     after the fracture has united is high. In analogy to the treatment of hip fractures in a~     similar patient population, patients might benefit from surgical treatment due to a reduction~     in pain and early mobilization.~   "
74575|NCT02590770|"~     The purpose of this study is to determine whether giving gaze-contingent feedback is an~     effective attention modification procedure, helping in the treatment of social anxiety~     disorder (SAD)~   "
74576|NCT02590757|"~     This study is a randomized controlled study to compare if a a non-invasive neurally adjusted~     ventilatory assist (NIV-NAVA) is better than nasal continuous positive airway pressure~     (N-CPAP) after extubation in infants' < 30 weeks of gestation.~   "
74577|NCT02590744|"~     This study is a single-center, prospective, randomized, controlled trial. To investigate if~     preoperative using of eye patch will decrease emergence agitation, and to provide a better~     method of decreasing emergence agitation to pediatric ophthalmic anesthesiologists.~   "
74578|NCT02590731|"~     Introduction: Femoral neck fracture is a devastating injury with serious medical and social~     consequences. One third of these patients have some degree of impaired cognitive status.~     Despite of this, a high proportion of hip fracture trials exclude patients with cognitive~     impairment. The investigators aimed to evaluate whether moderate to severe cognitive~     impairment could predict walking ability, quality of life, functional outcome, reoperations~     and mortality in elderly patients treated with hemiarthroplasty.~      Methods: This cohort study included a consecutive series of 188 patients treated with~     hemiarthroplasty for an displaced femoral neck fracture. Patient were assessed for estimated~     preoperative and 1 year postoperatively with regard to walking abilities, cognitive status,~     quality of life with EQ-5D and hip function with Harris hip score.~   "
74638|NCT02589951|"~     The purpose of this study is to determine the prevalence, etiology, and timing of missed~     Serious Medical Illness (SMI) in patients referred to adult psychiatry by emergency~     physicians, as well as to determine admission rates for SMI soon after discharge from an~     inpatient psychiatry admission.~   "
74580|NCT02590705|"~     The study is carried out in a prospectively randomly controlled way. In the context of~     acknowledgement and understanding from parents, by comparing with traditional process(no~     anesthesia), lidocaine surface anesthesia is randomly selected. All children will be~     evaluated by the FLACC (The face, legs, activity, cry, consolability behavioral tool) scale~     to quantitatively assess degree of pain during lumbar puncture. Time and success rate of the~     lumber puncture will be recorded and analyzed. A questionnaire about bad memory during lumbar~     puncture for all parents and children will be investigated in order to establish an optimized~     lumbar puncture management process.~   "
74581|NCT02590692|"~     The Phase I/IIa clinical trial is designed to assess the feasibility of delivery and safety~     of Human Embryonic Stem Cell-Derived RPE Cells on a parylene membrane (CPCB-RPE1) in patients~     with advanced, dry age-related macular degeneration.~      Primary Objective:~      • To test the safety and tolerability of CPCB-RPE1 during and after subretinal implantation~     in patients with geographic atrophy with evidence of involvement of the central fovea.~      Secondary Objective:~      • To assess visual acuity, visual field, and retinal function after CPCB-RPE1 implantation.~     Implanted and fellow eyes will be compared post-implantation to assess the ability of the~     implant to prevent disease progression.~      Exploratory Objectives:~      • To assess the feasibility of measuring the change in area of geographic atrophy over time~     using spectral domain optical coherence tomography or fundus autofluorescence.~   "
74582|NCT02590679|"~     Venus-P Valve (Venus Medtech, Shanghai, China) is the first self-expandable interventional~     Pulmonary Valve, which is composed of a Nitinol multilevel support frame with a tri-leaflet~     porcine pericardial tissue valve, and a 14-22 Fr delivery catheter. The purpose of the~     multi-center trial is to evaluate the safety and efficacy of the Venus-P Valve for~     percutaneous pulmonary valve implantation (PPVI) in patients pulmonary regurgitation and~     native right ventricular outflow tract (RVOT) after surgical repair of RVOT.~   "
74583|NCT02590666|"~     Hysteroscopy today is considered the gold standard for the diagnosis and treatment of~     endometrial polyps. Several hysteroscopic systems to resect endometrial polyps are currently~     available. Among Others bipolar systems and microscissors or graspers, both of theme make~     part of routine clinical practice and are universally accepted.~      The aim of the study is to compare the efficacy of bipolar resection energy polypectomy~     versus microscissors or graspers These procedures assume a lower cost and are associated with~     a lower surgical risk due to their realization without anesthesia .~      Hypothesis: Resection of polyps outpatient laser diode has a similar or superior to that of~     the bipolar electrode tolerability. The diode laser is a viable , quick , simple technique~     with a high percentage of resection and high degree of satisfaction of patients~   "
74584|NCT02590653|"~     The primary goal~      • To assess the effect of atorvastatin in patients treated since the first 24-96 hours of the~     disease on the parameters of global and regional myocardial deformation in the infarcted area~     and the structural and functional properties of arteries at day 7, at 12, 24, 36 and 48 weeks~     of treatment;~      The secondary goals. To evaluate the effect of treatment:~        -  on the parameters of the global and regional myocardial deformation in the intact area~          on day 7, on 12, 24, 36 and 48 weeks of treatment;~        -  on the parameters of the global and regional myocardial deformation depending on the~          degree of coronary blood flow restoration by thrombolysis in myocardial infarction~          (TIMI)~        -  on systolic and diastolic left ventricular function in the presence of initial~          impairments, or absence of the negative dynamics of these parameters in case of normal~          baseline values;~        -  on the clinical diagnostic criteria for the development or progression of heart failure;~        -  the dynamics of the duration and extent of myocardial ischemia according to the daily~          ECG monitoring on day 7, at 12, 24, 36 and 48 weeks of treatment;~        -  the appearance of new prognostically significant cardiac arrhythmias~        -  on the pulse wave velocity~        -  the thickness of the intima-media complex (IMT); 200 patients are planned to be include~          in a randomized, single-center, open, prospective, controlled clinical trial, the~          enrollment will be held at the Department of Therapy of Medical Institute of Penza~          State University.~      Definition of the study group:~      The patients with STEMI (myocardial infarction with ST-segment elevation) will be included in~     the study~        -  Group 1 STEMI - 100 patients receiving atorvastatin 80 mg / day for 48 weeks;~        -  Group 2 STEMI - 100 patients receiving atorvastatin 20 mg / day for 48 weeks Planned~          number of patients: Pre-Screening - 300 subjects; screening and randomization - 200~          subjects.~      Patients will be randomized by random number generation to include in the group 1 or 2. All~     included patients will be on the standard basis therapy of the coronary artery disease,~     according to the national recommendation.~   "
74585|NCT02590640|"~     The goal of this study is to determine if a specific experimental brain stimulation technique~     can be used as a non-invasive way to reduce cigarette cravings in current smokers. This study~     plans to learn more about the way an experimental technique called transcranial magnetic~     stimulation (TMS) affects a specific part of the brain, called the insula. Some research~     suggests that this part of the brain plays an important role in craving. The investigators~     plan to study the effects of TMS using standard surveys and magnetic resonance imaging (MRI)~     of subjects' brain.~      For interested participants, this study requires a single 3 hour appointment, which will~     include MRI of the brain as well as TMS.~   "
74586|NCT02590627|"~     Drug efficacy testing is one of the most important tasks that is routinely undertaken by the~     National Malaria Control Program (NMCP) in Tanzania and has been recommended by the World~     health Organisation to monitor the efficacy of artemisinin based combination therapy (ACT)~     and possibly detect evolution/emergency of tolerance/resistance to these drugs. Currently,~     Artemether-lumefantrine (ALu) is the only ACT recommended by the Ministry of Health and~     Social Welfare and therefore testing of new ACTs such as dihydroartemisinin-piperaquine~     (DHA-PQ) is important because alternative drugs are urgently required. Meanwhile, NMCP is~     revising the guidelines for treatment of malaria in Tanzania and DHA-PQ has been earmarked as~     an alternative ACT to be used together with ALu. However, efficacy and safety data of DHA-PQ~     is missing since no studies have been done in Tanzania. Thus, a study is proposed to assess~     the efficacy and safety of DHA-PQ Vs ALu and provide important data which will enable the~     NMCP to make informed decisions; and possibly recommend DHA-PQ in the new Malaria treatment~     guidelines as the second line drug for the treatment of uncomplicated malaria in the country.~   "
74587|NCT02590614|"~     Determine differences in serum vitamin D metabolism by genetic ancestry.~   "
74588|NCT02590601|"~     Peripartum cardiomyopathy (PPCM) is a rare, but significant heart disease affecting young~     women in the puerperal period. Thus far, no specific treatment has been approved to treat~     this disease. PPCM has a wide spectrum of clinical manifestations ranging from mild heart~     failure to severe cardiomyopathy, cardiogenic shock and death. A significant proportion of~     survivors have persistent chronic heart failure leading to disabling symptoms and decreased~     quality of life.~      Animal studies have suggested that prolactin is central to the development of PPCM. Prolactin~     has pro-inflammatory and anti-angiogenic effects that may promote PPCM. Bromocriptine, a~     central dopamine agonist known to decrease prolactin levels, might thwart its deleterious~     effects in women suffering from PPCM. Following this rationale, bromocriptine should improve~     myocardial function in women suffering from PPCM and thus, improve cardiovascular outcomes~     and healthcare outcomes.~   "
74589|NCT02590588|"~     The investigators expect to enroll 15 participants with relapsed or refractory IgM-associated~     AL amyloidosis onto this Phase II clinical trial. Idelalisib will be self-administered orally~     at a dose of 100 mg twice daily (may be increased to 150 mg (one tablet) twice daily after 3~     months at investigator discretion). Participants will be treated until disease progression,~     unacceptable toxicity, or decision to withdraw from the trial. Disease evaluations will be~     performed every three months until disease progression.~   "
74590|NCT02590575|"~     The purpose of this study is to test the effectiveness of a membrane gas exchange device in~     the venovenous circulation of a continuous renal replacement therapy for the purpose of CO2~     elimination and pH compensation. Thus, the primary endpoint is the modification of the PaCO2~     and/or the ventilator settings (tidal volume VT and plateau pressure Pplat).~   "
74591|NCT02590562|"~     This observational study will describe the treatment patterns of usage of biological DMARDs~     in routine clinical practice and the demographics and RA disease characteristics in patients~     suffering from rheumatoid arthritis. Patients will be recruited and examined the same day~     when recruited. There will be no follow up visit or treatment period only one visit in this~     study.~   "
74592|NCT02590549|"~     A complete intrastromal ring, MyoRing (Dioptex, GmbH, Linz, Austria), suggested by Albert~     Daxer in 2007, is a relatively new technique that has been demonstrated to treat keratoconus~     safely and effectively.Corneal collagen crosslinking (CXL), introduced by Wollensak et al. in~     2003, has become a standard treatment for progressive keratoconus to slow or possibly stop~     progression of disease.~      The formation of the stromal pocket during MyoRing implantation offers the opportunity for~     simultaneous introduction of riboflavin 0.1% into the pocket followed by UVA irradiation to~     provide combined treatment in patients with progressive keratoconus.~   "
74593|NCT02590536|"~     This is a Randomized Controlled Trial to evaluate the effect of sildenafil on Doppler~     velocity indices of the umbilical arteries in patients with placental insufficiency and fetal~     growth restriction, and if sildenafil can improve fetal and neonatal outcomes in those~     patients.~   "
74594|NCT02590523|"~     The goal of this study is to determine the safety (but not efficacy in preventing infection)~     of sterile-packaged and pre-loaded injectable solutions of both vancomycin and moxifloxacin~     at certain dosages and concentrations as prepared by a compounding pharmacy when used~     intracamerally at the time of cataract surgery.~   "
74595|NCT02590510|"~     The main purpose of this study is to compare the effect of 10 mg and 15 mg methotrexate in~     the treatment of meningeal carcinomatosis.~   "
74596|NCT02590497|"~     This pilot clinical trial studies the correlation between the genetics and brain images of~     patients with newly diagnosed glioblastoma before surgery. The genetic characteristics of a~     tumor are an important way to predict how well it will respond to treatment. Imaging, using~     magnetic resonance imaging (MRI), takes detailed pictures of organs inside the body, and may~     also provide information that helps doctors predict how brain tumors will respond to~     treatment. If MRI can provide doctors with similar information about the tumor as the tumor's~     genes, it may be able to be used to predict tumor response in patients whose tumors cannot be~     reached by surgery or biopsy to get tissue samples.~   "
74597|NCT02590484|"~     Placenta previa and placenta accrete carry significant maternal and fetal morbidity and~     mortality. Several techniques have been described in the literature for controlling massive~     bleeding associated with placenta previa cesarean sections. The aim of this study is to~     evaluate the efficacy and safety of the use of the cervix as a natural tamponade in~     controlling postpartum hemorrhage caused by placenta previa and placenta previa accreta.~   "
74598|NCT02590471|"~     Comparison of two methods for revascularization of the superficial femoral artery: stenting~     of the superficial femoral artery vs. stenting of the superficial femoral artery supplemented~     with fasciotomy in Hunter canal in patients with steno-occlusive lesion of the~     femoro-popliteal segment of TASC C, D.~   "
74599|NCT02590458|"~     The goal of this clinical research study is to test if a short breast MRI scan (about 10~     minutes) can be used for breast cancer screening in high risk people and to learn if it is as~     effective as a routine breast MRI scan (30-60 minutes).~   "
74600|NCT02590445|"~     Refractory obsessive-compulsive disorder (OCD) is a disabling condition. Deep brain~     stimulation (DBS) of ventral capsule/ventral striatum(VC/VS) is potentially the most~     effective treatment for refractory OCD. However, the affecting area of traditional electrodes~     is limited and not specific to VC/VS. The investigators designed a novel electrode, 2 mental~     contacts(3mm contact-2mm space-3 mm contact) could be implanted in ventral striatum and the~     other upper 2 contacts(4mm space-3mm contact-4mm space-3mm contact)that can be implanted in~     ventral capsule simultaneously, which the investigators believe will be more effective due to~     better compatibly with anatomical features of target area. This trial is to evaluate the~     effectiveness and safety of this approach.~   "
74601|NCT02590432|"~     The primary objective of this study is to assess the potential of linaclotide treatment to~     induce the development of anti-drug antibodies (ADAs). The secondary objectives are to~     provide additional evidence supporting the long-term safety and efficacy of linaclotide in~     adult irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation~     (CIC) patients and to evaluate lower doses of linaclotide.~   "
74602|NCT02590419|"~     Using Synaptive Medical's BrightMatter™ products to better visualize and plan epilepsy~     surgeries by considering white matter tracts, and considering whether the technology results~     in improved clinical outcomes.~   "
74603|NCT02590406|"~     The risk of complication associated with airway in obese patient is important. The result of~     pre-oxygenation gives the clinician a prolonged non-hypoxic apnea time. The relation between~     FRC and non-hypoxic apnea time has been correlated. However, the best condition to accomplish~     the pre-oxygenation in morbidly obese patient has yet to be described in the medical~     literature. A study previously done in our hospital (EPO2-PV) compared the effect of~     different positions and ventilation modes on the FRC in the laboratory. A significant~     difference has been established on the FRC between the inverse Trendelenburg position with~     positive pressure ventilation and the head up (beach-chair) position without positive~     pressure. The current study, EPO2-A is designed to compared the two positions and ventilation~     modes during the induction of general anesthesia on morbidly obese and correlate the~     difference in FRC to difference in apnea time.~   "
74604|NCT02590393|"~     The purpose of this study is to learn more about the nicotine and non-nicotine chemicals that~     are part of e-cigarettes and their effects on cigarette smokers by assessing smokers'~     experiences with different e-cigarettes using a battery of self-report, biochemical, and~     behavioral indices. This is not a smoking cessation study; smokers will not be asked to quit~     smoking, and e-cigarettes will not be used as a medical device or therapy.~   "
74605|NCT02590380|"~     Evaluation of the efficacy of the K2M MESA Rail™ Deformity System at improving coronal and~     sagittal correction of the adolescent idiopathic spine deformity in comparison to the side~     loading DePuy Synthes USS II pedicle screw system.~   "
74606|NCT02590367|"~     The purpose of this study is to estimate the usefulness and safety of HD6610 granule for~     oxaliplatin-induced peripheral neuropathy. The investigators examined the efficacy and safety~     of the treatment algorithm for 64 patients with colorectal cancer by evaluating the side~     effects and degree of improvement of subjective symptoms.~   "
74607|NCT02590354|"~     HIV-1 infected patients with normal peripheral blood CD4+ T-cell counts and undetectable~     viral load will be recruited in four Belgian HIV reference centers. Selected patients will~     undergo a two-step screening in which a viral reservoir measurement will be performed and~     among those with a very low viral reservoir an analytical treatment interruption of their~     longstanding antiretroviral therapy (ART). There is no randomization foreseen. Patients will~     receive an intense clinical and laboratory follow-up during 48 weeks followed by 12 weeks~     post intervention.~   "
74608|NCT02590341|"~     MYKKE is a prospective multi-center registry for children and adolescents with myocarditis.~     The aim is to generate prospective multi-center data on epidemiology, diagnostics, and~     therapy of pediatric patients with myocarditis in order to enable evidence-based diagnostic~     and therapeutic approaches for this myocardial disease.~   "
74609|NCT02590328|"~     The goal of the proposed research is to observe the prevalence and establish the validity of~     a newborn screening method for severe combined immunodeficiency (SCID). The assay to be used~     is developed on the basis of PCR quantification of T-cell receptor excision circles (TRECs)~     that is absent in SCID patients, thus correlating with the disease.~   "
74610|NCT02590315|"~     Preliminary results from prospective screening trials show that Digital Breast Tomosynthesis~     (DBT) is more sensitive and more specific than conventional digital mammography (DM).~     However, large randomised controlled trials (RCTs) are needed to confirm these promising~     results. Furthermore, potential side effects of DBT in the screening setting have to be~     properly evaluated. In particular, the major concern is about overdiagnosis and its~     consequences; overdiagnosis refers to the detection of cancers at screening, which would not~     have become clinically apparent in the woman's lifetime.~      This RCT was designed to compare benefits and harms of DBT in a population-based screening~     program with conventional DM. The primary outcome parameter will be the difference between~     the two tests in rates of advanced cancers detected at the subsequent round and interval~     cancers (within the first two years after the study screening round). Secondary outcomes~     measures will be diagnostic performance indicators for organised breast screening (i.e,~     cancer detection rate, recall rate, false positive rate, positive predictive value),~     parameters used in cost-effectiveness analysis, pathologic and biological characteristics of~     screen-detected cancers.~   "
74611|NCT02590302|"~     The overarching goal of this project is to improve timely access to appropriate mental health~     (MH) care for children and youth. The investigators will conduct and rigorously evaluate~     implementations of this pathway in four exemplar hospitals and associated CMHA dyads within a~     local health region. Outcomes-based validation of this pathway is important for effective~     adoption in other communities. A multiple baseline study design and conduct interrupted~     time-series analysis will be used to evaluate whether the EDMHCP has resulted in improved~     health care utilization, medical management, and health sector coordination. To ensure EDMHCP~     feasibility in various settings, implementation will occur in four exemplar~     hospital-community dyads with different workflows and patient populations.~   "
74612|NCT02590289|"~     To assess the pharmacokinetics of 3 doses and the food effect of a single high dose of~     BBI-5000 capsules in healthy adult subjects.~   "
74613|NCT02590276|"~     The project focuses on C9orf72, the most frequent genetic form of frontotemporal dementias~     (FTD, or frontotemporal lobar degeneration, FTLD) and amyotrophic lateral sclerosis (ALS).~     FTD is the second commonest cause of degenerative dementia in presenium after Alzheimer's~     disease. Behavioural and cognitive impairments progressively lead to dementia. ALS produces~     progressive muscle weakness leading to the death in 2 to 4 years. Since 2006, major~     discoveries have linked FTLD and ALS:~        1. TDP-43 aggregates in neurons and~        2. C9orf72 mutations is a major genetic cause in both disorders.~      Two major pathological subtypes are now defined in FTD, FTD-TDP and FTD-TAU. C9orf72~     mutations (associated to FTD-TDP) are the most frequent genetic causes of FTD (15%), FTD-ALS~     (65%) and ALS (40%).~      FTD is difficult at an early stage; and no clinical, biological or imaging features can~     predict the underlying pathology in living patients. Therapeutic perspectives emerged against~     tau aggregation, progranulin deficit and C9orf72 expansion (antisense). Presymptomatic~     carriers of genetic FTD would benefit, before onset of symptoms, from these therapeutic that~     would delay or prevent the disease. At this step, it becomes crucial to develop markers to~     know how many years before symptoms, does the pathological progress begin, to treat the~     patients at the most early stage of the disease. Markers are also needed to predict the~     pathology (FTD-TDP/FTD-tau) in patients that will be eligible for trials targeting specific~     pathological lesion.~   "
74614|NCT02590263|"~     This study seeks to evaluate the tolerability, pharmacokinetics (PK), efficacy, and safety of~     ABT-414 in Japanese participants with newly diagnosed and recurrent, World Health~     Organization (WHO) grade III or IV malignant glioma.~   "
74615|NCT02590250|"~     This is a Post-Marketing Surveillance study in India to evaluate safety and efficacy of~     BOTOX® (Botulinum Toxin Type A) in the treatment of patients with urinary incontinence due to~     neurogenic detrusor overactivity or overactive bladder.~   "
74616|NCT02590237|"~     The purpose of this study is to determine whether the Ambu KingVision videolaryngoscope~     performs as well as direct laryngoscopy for intubating small children and infants.~   "
74639|NCT02589938|"~     This study is being done to find out what effects, good and/or bad, acupuncture has on~     participants and their xerostomia caused by radiation therapy for the treatment of the~     cancer.~   "
74617|NCT02590224|"~     Iron deficiency anemia during pregnancy is a significant worldwide health problem, affecting~     22% of pregnant women in industrialized countries and 52% in non-industrialized countries.~     Iron deficiency anemia during pregnancy is associated with increased maternal as well as~     fetal morbidity, including prematurity, low birth-weight and perinatal and infant loss.~     Therefore, routine iron supplementation during the second half of pregnancy has been~     recommended once daily. Others, however, support a selective iron supplementation only for~     women with iron deficiency anemia, in order to avoid the increased risk of haemoconcentration~     associated with routine iron supplementation. Unfortunately, compliance to either~     iron-supplementation programs, especially among pregnant women, is poor, due in part to the~     side effects associated with these preparations.~      Currently, there are many iron preparations available containing different types of iron~     salts, including ferrous sulfate, ferrous fumarate, ferrous ascorbate but common adverse drug~     reactions found with these preparations are mainly gastrointestinal intolerance like nausea,~     vomiting, constipation, diarrhea, abdominal pain, while ferrous bis-glycinate (fully reacted~     chelated amino acid form of iron) rarely make complication.~      Product resulting from the reaction of a metal ion from a soluble salt with amino acids to~     form coordinate covalent bonds, the resulting molecule is called as chelate and chemical~     bonding process is called chelation. Ferrous bis-glycinate is highly stable and totally~     nutritionally functional chelate it is an amino acid fully reacted chelate which is formed by~     the binding of two molecules of glycine to one Fe2+ atom.~   "
74618|NCT02590211|"~     The PERHAPS project aims to fill two gaps in the scientific literature: on the one hand,~     studying the clinical and cognitive particularities of poker-related problems, and on the~     other hand, studying poker skill as a combination of multiple cognitive and emotional~     abilities. The underlying clinical aim is to develop a cognitive remediation therapy program~     dedicated to pathological gamblers.~   "
74619|NCT02590198|"~     Neonatal bacterial infection remains a serious pathology in industrialized countries despite~     the use of prophylaxis measures for group B streptococcus (GBS) (peri-partum antibiotic in~     women with GBS colonization), which was implemented in the United States in 1996 and in~     France in 2001 and has led to a dramatic decrease in the incidence of neonatal bacterial~     infections. However, early onset neonatal infection (EONI), which is defined as an infection~     occurring during the first 6 days after birth (as opposed to late onset neonatal infections~     (LONI) occurring between days 7-89), is still one of the leading causes of neonatal morbidity~     and mortality. Physicians consider EONI a significant diagnostic and therapeutic emergency~     due to the potential for sudden onset and rapid evolution of sepsis in newborns with immature~     immune systems. Currently, in France, detection of EONI is based on national consensus~     guidelines published in 2002 (ANAES recommendations). There are broad indications to provide~     empirical antibiotic treatment pending diagnostic confirmation through different~     complementary exams. To ensure that every infected newborn is diagnosed, biological~     assessments are often repeated and result in the use of invasive and painful procedures,~     anemia and financial concerns. Moreover, in cases of abnormal biological results, many~     newborns are subjected to intravenous (IV) antibiotic treatments requiring hospitalization~     and separation from their mother. However recent studies have shown that antibiotics can have~     a potentially deleterious effect on the neonatal digestive microbiota and result in the~     appearance of antibiotic-resistant bacteria, with possible long-term consequences on the~     health of the child.~      Procalcitonin (PCT) is a calcitonin prohormone secreted from the parenchymal tissues. This~     marker of inflammation has been shown to be a valuable diagnostic marker for bacterial~     infection in adults and in children. It also seems to be a reliable marker for neonatal~     bacterial infection, which would make it useful in the detection of EONI. Because~     physiological levels of PCT vary during the first days of life, possibly due to postnatal~     intestinal bacterial colonization, levels of this marker are difficult to interpret in the~     early neonatal period. However, in a study of 2151 newborns with suspected EONI, Nicolas~     Joram et al. found that PCT obtained from the umbilical blood cord, prior to newborn~     intestinal colonization, bypasses this postnatal physiological peak of PCT and effectively~     constitutes a discriminant marker to distinguish between infected and healthy infants using a~     cutoff value of 0.6 ng/ml.~      Subsequent to this pilot study, several studies on PCT in umbilical blood cord confirmed its~     good diagnostic performance for EONI, particularly when included in a diagnostic algorithm.~     This marker could contribute to a better estimation of EONI risk in order to limit the use of~     unnecessary complementary exams and prescription of antibiotics and their associated short-~     and long-term side effects in healthy newborns.~      Therefore, in this study, the investigators propose to test the diagnostic value of a~     PCT-based algorithm in newborns suspected of having EONI. The investigators hypothesize that~     this algorithm is as efficient as those currently used (ANAES), but will limit coinciding~     biological exams and exposure to antibiotics during the neonatal period.~   "
74620|NCT02590185|"~     Regarding the direct costs and the social value of depression, the decision of an~     antidepressant treatment prescription must be optimized as much as possible. The development~     of a personalized medicine in psychiatry may reduce treatment failure, intolerance or~     resistance, and hence burden and costs of affective disorders.~      There is hope that biomarkers will be found to guide treatment selection. It might be of~     decisive interest to be able to assess an individual's metabolism activity. We propose here~     to explore the relationship between the activity of drug-metabolizing enzymes (DME) and~     transporters- assessed by a phenotypic approach and the efficacy of antidepressants. We will~     focus on venlafaxine (V) that provides a reasonable second-step choice for patients with~     depression and is used extensively in psychiatric practice, and the metabolism of which~     involves several cytochromes (CYP) P450 enzymes and the transporter P-gp.~      Thus, the primary objective of this study is to study the correlation between the~     concentration of V and its metabolite ODesmethylV (V+ODV) and drug metabolism variability~     assessed by a phenotypic approach, in patients with major depressive disorder and MADRS ≥ 20~     despite 4 weeks of V at 150mg or less~   "
74621|NCT02590172|"~     In France, Intensive Medicine is carried out in three types of structures: intensive care~     units, intensive care unit and units Continuous Monitoring (USC). Created in the 90s as~     intermediate structures between conventional care units and intensive care units, these units~     are assigned to the care of patients whose conditions and treatment are fear the occurrence~     of one or more critical failures requiring to be monitored, or whose condition, at the end of~     one or more critical failure is too severe or unstable to allow a return to a classical~     inpatient unit.~      Thus, USC represent a milestone in the journey of patients whose condition is critical:~     patients from the emergency services, patients in the immediate postoperative period, coming~     out of intensive care patients, or finally in conventional hospitalization patients whose~     condition s 'worse. The creation of the USC is not subject to authorization but must be~     contractualized between the hospital and the Regional Health Agency (ARS) because it is~     resource intensive. Organizations and their operating modes are guided by the recommendations~     of the French Society of Anesthesia and Intensive Care (SFAR), and the Society of French~     Language Resuscitation (SRLF) published in 2005.The US establishment has a beneficial effect~     on the quality of care and the care pathway of patients at risk shown by the reduction in~     morbidity and mortality, the rate of admission and / or USC readmission of length of stay and~     hospital stay costs.~      It is possible to objectify provided first establish an inventory on the activity of these~     units and the patient base supported. To judge the benefit of the assumption by the USC, it~     is necessary to assess the adequacy of patients managed with an updated specification and~     defined by a group of experts.~   "
74622|NCT02590159|"~     Single center clinical study for the BONGO NASAL EPAP device in the treatment of obstructive~     sleep apnea for the purpose of obtaining safety and efficacy data~   "
74623|NCT02590146|"~     This study will examine the use of non-pharmacologic pain control techniques and~     pain-management counseling as an additional tool for reducing pain during first trimester~     aspiration abortion.~   "
74624|NCT02590133|"~     We define refractory nasopharyngeal carcinoma as the following: recurrence with radiation~     brain injury after radiotherapy, recurrence after the second or more courses of radiotherapy,~     standard treatment failure after recurrence, and first-line treatment failure after multiple~     distant metastasis.~      There is no standard treatment for refractory nasopharyngeal carcinoma. Platinum plus 5-Fu is~     the classic regimen for primary treatment of nasopharyngeal carcinoma.~      Endostatin is a multiple targeted angiogenesis inhibitor acting on tumor associated~     neovascular endothelial cells, normalizing the morphology and function of tumor vasculature,~     and indirectly leading to the quiescence or reduction of tumors.~      The purpose of this phase II clinical trial is to determine the efficacy and safety of~     nedaplatin plus continuous low dose 5-Fu intravenous infusion combined with endostar®~     (Recombinant Human Endostatin Injection) continuous intravenous infusion compared with~     nedaplatin plus continuous low dose 5-Fu intravenous infusion alone in refractory~     nasopharyngeal carcinoma.~      The study hypothesis is that nedaplatin plus continuous low dose 5-Fu intravenous infusion~     combined with endostar® continuous intravenous infusion is effective and safe in refractory~     nasopharyngeal carcinoma.~   "
74625|NCT02590120|"~     The purpose of this study is to evaluate amino acid absorption with two different type of~     proteins.~   "
74626|NCT02590107|"~     This clinical trial studies the use of early oral supplementation in improving nutritional~     status in participants undergoing hematopoietic stem cell transplant. Impaired nutritional~     status in participants undergoing hematopoietic stem cell transplant has been linked to~     decreased outcomes such as increased length of hospital stay and increased time to~     engraftment (an important milestone in transplant recovery). Early oral supplementation may~     increase nutritional status and help to promote a positive outcome in participants undergoing~     transplant.~   "
74627|NCT02590094|"~     To compare outcomes in subjects receiving different doses and treatment intervals of~     intravitreal bevacizumab or ziv-aflibercept preoperatively administered prior to undergoing~     vitrectomy for complications of proliferative diabetic retinopathy.~   "
74628|NCT02590081|"~     This is a prospective, randomized, double-blind, parallel group trial to assess the efficacy~     and safety of intravenous dextrose 5% solution compare with normal saline (standard care) in~     wash back procedure during haemodialysis in patients with end stage renal failure (ESRF) with~     respect to systolic blood pressure control over 3 months period.~      The primary objective is to establish efficacy of 5% dextrose solution compared with normal~     saline (0.9% sodium chloride solution) with respect to systolic blood pressure control in~     subjects with end stage renal failure (ESRF) on regular hemodialysis. Secondary objectives~     include monitoring the change in body weight, thirst level and body fluid volume.~   "
74629|NCT02590068|"~     This study aims to identify the innate and adaptive immune response to zoster vaccination.~     Half of the participants will be individuals with chronic hepatitis C, while the other half~     with healthy volunteers.The innate immune signature elicited by Zoster vaccination will be~     characterized by RNA-seq analysis of pre- and post-vaccination RNA from whole blood. We will~     compare fold changes in gene expression profiles pre- versus post-vaccination in each~     individual, as well as between the two arms of the study. RNA-seq will be used to assess~     innate immune activation by evaluating the changes to the expression levels of~     interferon-stimulated genes pre- and post-vaccination. Adaptive immune response will be~     determined by the traditional correlates of protection used in previous Zoster clinical~     studies in addition to flow cytometry24. Correlates of protection include antibody response,~     interferon gamma production and the frequency of responder cells post- vaccination24. For~     antibody production, we will perform Zoster glycoprotein ELISA (gpELISA) targeting IgG/IgM.~     The number and frequency of responder cells will be characterized by flow cytometry.~   "
74630|NCT02590055|"~     It's a phase 2, single arm study of gemcitabine an docetaxel combination in patients with~     carcinoma of unknown primary.~   "
74631|NCT02590042|"~     A single-arm, open-labeled, single-center, descriptive and exploratory safety trial using~     ADSC-SVF-002. ADSC-SVF-002 is an autologous adipose derived stem cell (ADSC)-containing~     stromal vascular fraction (SVF) obtained from subcutaneous fat harvested by liposuction from~     a patient. As a cellular therapy product, ADSC-SVF-002 (fresh or cryopreserved) will be~     administered subcutaneously via injection, with or without unprocessed autologous fat (fresh~     or cryopreserved), into soft tissue defects and abnormally healing wounds. The primary~     objective of the trial is to demonstrate the safety of ADSC-SVF-002 in a population of~     subjects with soft tissue defects or abnormal wound healing who are still symptomatic despite~     being managed by conventional therapies.~   "
74632|NCT02590029|"~     The purpose of this randomized study is to determine the impact of three different types of~     psychosocial support delivered by social workers to patients reporting uncontrolled pain~     during a hospital stay. This study will examine the differential effects of brief mindfulness~     training, therapeutic suggestion, and psychoeducation for patients reporting uncontrolled~     pain.~   "
74633|NCT02590016|"~     Pregnant women with gestational diabetes who are treated with insulin and their daily insulin~     dose is 30 IU or more will be randomized into two groups. Active treatment group will recieve~     insulin-glucose-infusion during labour. In the observational group, blood glucose level~     during labour will be monitored and insulin-glucose-infusion is started only if needed. The~     hypothesis is that there will not be a difference in rate of hypoglycemia between the two~     groups and that the proportion of observational group participants that need infusion is low.~   "
74634|NCT02590003|"~     This study will enroll elderly patients with advanced non-small cell lung cancer who are at~     high risk of developing chemotherapy toxicity (side effects). Patients will receive treatment~     with either a platinum-based doublet chemotherapy with carboplatin/nab-paclitaxel or single~     agent nab-paclitaxel of chemotherapy. Response to treatment and treatment toxicity will be~     compared in the two treatment groups to determine the best treatment strategy for this group~     of patients.~   "
74635|NCT02589990|"~     The study investigates the effect of maximal strength training on muscular strength and power~     in different age groups from 20 to 80 year old. It also relates the training adaptations to~     different known genes such as angiotensin I-converting enzyme (ACE) and Alpha-actinin-3~     (ACTN3). Participants will complete an eight weeks, three times per week training~     intervention of maximal strength training with a pre-post design. In addition, blood samples~     will be collected for the analyses of genetic variances.~   "
74636|NCT02589977|"~     Unlike heart failure with reduced ejection fraction (HFrEF) where several medicines and~     devices have been demonstrated to reduce mortality, no such therapies have been identified in~     HFpEF. This may be in part due to incomplete understanding of the underlying mechanisms of~     HFpEF.~      Recently, impaired myocardial blood flow, reduced myocardial energy utilization, and~     increased myocardial fibrosis have been postulated to play important pathophysiologic roles~     in HFpEF. The investigators and others have demonstrated that HFrEF may be associated with~     altered myocardial energy utilization and energy starvation. However, there are limited~     data regarding energy starvation in HFpEF and the relationships between myocardial blood~     flow, energy utilization, and fibrosis in HFpEF are largely unknown. Therefore, the purposes~     of this study are to use non-invasive cardiac imaging techniques to describe cardiac~     structure, function, blood flow, energetics, and fibrosis, and the relationships between~     these in order to better understand underlying mechanisms in HFpEF.~   "
74637|NCT02589964|"~     The study will evaluate the effectiveness of probiotic therapy in reducing the incidence of~     antibiotic associated diarrhea (AAD) and Clostridium difficile associated diarrhea (CDAD) in~     pneumonia patients.~   "
87980|NCT02415491|"~     Magnetic Resonance Imaging of the heart at rest and stress conditions relative to the~     cardiopulmonary exercise capacity in young adults after neonatal surgery for transposition of~     the great arteries.~   "
74641|NCT02589912|"~     The Nucleus 24 Auditory Brainstem Implant (ABI) is the only FDA approved device for~     restoration of meaningful hearing in Neurofibromatosis Type 2 (NF2) patients. This device has~     been discontinued, meaning that there is no commercially approved device currently available.~     The replacement model, the ABI541 (an unapproved device), is being investigated in ongoing~     clinical trials. A compassionate use arm of a clinical trial allows patients with NF2 to be~     implanted with this new ABI.~   "
74642|NCT02589899|"~     A novel algorithm for bioimpedance measurements to detect nerve tissue, and discriminate it~     from other tissue types has been developed in a porcine model, by analysing a complex~     impedance dataset based on multiple measurement frequencies. It must now be confirm that the~     previous results are applicable in humans. Measurements from 24 predefined needle positions~     will be obtained in 16 of the 32 volunteers that are included in the study (part A). A new~     algorithm to detect nerve tissue will be developed based on these measurement results.~     Further impedance algorithms will be developed for other tissue type. The efficacy of the~     algorithms (sensitivity and specificity) will be evaluated in the 16 following volunteers~     (part B).~   "
74643|NCT02589886|"~     A randomised trial to the effect of a newly developed education and self help intervention~     for patients with a functional motor disorder on general health, quality of life, illness~     perception, symptom severity and other secondary outcome measures.~   "
74644|NCT02589873|"~     This study evaluates two group-based Diabetes Prevention Program (DPP) lifestyle~     interventions delivered in the workplace to individuals at risk for pre-diabetes: 1) an~     in-person group-based lifestyle intervention; and 2) an internet-based intervention delivered~     using an online platform with lifestyle coaching support. Eligible participants will be~     randomized equally to each intervention program (120 participants in each).~   "
74645|NCT02589860|"~     This is a pilot study to explore and identify changes in molecular processes within the oral~     mucosa that are associated with the development of oral mucositis (OM) in patients treated~     with Melphalan who undergo autologous peripheral blood stem cell transplantation.~   "
74646|NCT02589847|"~     This study will evaluate efficacy and safety information about RBX2660 for the treatment of~     recurrent Clostridium difficile infection (CDI). Enrolled subjects will receive one treatment~     with RBX2660 (microbiota suspension).~   "
74647|NCT02589834|"~     Postoperative pain management is crucial for surgical patients. Management of postoperative~     pain entails reducing painful symptoms, improving the quality of recovery and resuming normal~     daily living activities. In addition to the benefits derived from relieving postoperative~     pain in women undergoing cesarean section, prolonged immobility as a result of pain during~     puerperium is associated with risk of thromboembolic disease.~      Postoperative pain has negative physiological and psychological impact on patients'~     well-beings and delays the postoperative recovery. Pain may also impair the mother's ability~     to provide an optimal care for her infant in the immediate postpartum period. Besides that,~     it also reduces the maternal ability to breast-feed her infant effectively.~      Effective pain relief should not interfere with the mother's ability to move around and care~     for her infant, and that it results in no adverse neonatal effects in breast-feeding women.~      Non-pharmacological techniques for reduction of pain are growing rapidly. Spiritual~     intervention with listening to Quran recitations as an adjunctive therapy in the~     postoperative period is a non-pharmacological technique that is inexpensive, non-invasive and~     has no side-effects. Spiritual and Islamic implication could improve postoperative pain 6-8~     hours and 24-30 hours in Muslim patients undergoing abdominal surgery. However, there is~     limited number of published studies on the effect of spiritual and religious intervention on~     pain after cesarean section.~      Listening to Quran recitation elicits a relaxation response of calmness, mindfulness, and~     peacefulness in Muslims. Pray therapy results in optimal harmonization, which improves~     psychological, social, spiritual, and physical health status.~      The current study aims to investigate the effects of listening to Quran recitation on pain~     intensity among patients after cesarean section according to the cultural, social and~     economic differences in Egypt.~   "
74648|NCT02589821|"~     A randomized, double-blind, placebo controlled, multi-center Phase III study to assess the~     efficacy of Sulfatinib 300 mg once a day in treating advanced pancreatic neuroendocrine~     tumors.~   "
74649|NCT02589808|"~     This study will compare findings using a handheld ultrasound device (GE VScan) with those~     using a diagnostic ultrasound machine in adult patients referred for transthoracic echo~     (TTE), prior to non-cardiac surgery at Hammersmith Hospital, London.~      The handheld TTE (VTTE) will follow the standard Hammersmith Hospital diagnostic TTE (DTTE)~     protocol (with the exception of spectral Doppler) and will be reported on a simple 'tick box'~     form. A different echocardiographer will then perform and report the DTTE as per routine~     practice. The results from VTTE and DTTE will be directly compared. The echocardiographers~     performing the VTTE and DTTE are all fully accredited in diagnostic TTE and will be blinded~     to each others findings.~      The study aims to recruit a total of 96 patients with an anticipated study completion date of~     November 2015.~   "
74650|NCT02589795|"~     CUTHIVAC002 is a randomised Phase I study aimed at exploring the safety and immunogenicity of~     two different modes of delivery of a deoxyribonucleic acid (DNA) vaccine (DNA-C CN54ENV) via~     combined intramuscular and intradermal methods with and without electroporation, and boosted~     with recombinant HIV CN54gp140 administered by intradermal injection in healthy volunteers.~      The aim of this study is to identify optimal DNA delivery conditions for promoting enhanced~     antibody responses to boosting with recombinant protein by the intradermal method.~   "
74651|NCT02589782|"~     TB PRACTECAL is a multi-centre, open label, multi-arm, randomised, controlled, phase II-III~     trial; evaluating short treatment regimens containing bedaquiline and pretomanid in~     combination with existing and re-purposed anti-TB drugs for the treatment of biologically~     confirmed pulmonary multi drug-resistant TB (MDR-TB).~   "
74652|NCT02589769|"~     A randomized controlled clinical trial comparing the effect of substitution of unsaturated~     fat from nuts and oils for saturated fat from meat and dairy foods on serum lipids in normal~     weight and obese subjects with elevated LDL cholesterol.~   "
74684|NCT02589353|"~     Although salivary contents play a major role in the early stage of food digestion process,~     their role in taste perception of glucose polymers is essentially unknown. It is hypothesized~     that the differences in salivary contents, more specifically salivary amylase concentration~     and activity, influence taste perception of glucose polymers and ultimately eating behavior,~     which is related to risks in various diseases. The current project is designed to investigate~     2 aims. Aim 1 will investigate the variation in salivary contents across individuals and its~     role in taste perception of glucose polymers. Aim 2 will focus on the role of salivary~     contents in food liking and disliking.~   "
74685|NCT02589340|"~     The primary objective of this study is to evaluate the efficacy of buspirone in combination~     with amantadine in reducing levodopa-induced dyskinesia (LID) in patients with Parkinson's~     disease (PD).~   "
74653|NCT02589756|"~     Obesity represents one of the most important public health challenges for the societies.~     Although excess energy intake and physical inactivity are major causes of obesity and~     cardiometabolic disorders, emerging evidence has linked persistent organic pollutants (POPs)~     with the global epidemic of type 2 diabetes. However, the potential impacts of POPs on~     obesity and cardiometabolic risk in humans remain poorly known. On the other side systematic~     reviews and meta-analyses conducted in recent years strongly support a protective association~     between eating nuts and CVD. The investigators will conduct a randomized controlled clinical~     trial in adults. The main research questions are: a. Does consumption of fatty fish increase~     levels of POPs in overweight and obese adult norwegian men and women compared to a control~     group not consuming fatty fish? b. Does consumption of fatty fish affect markers of~     cardiometabolic risks (blood pressure, lipids, glucose and CRP) in overweight and obese adult~     norwegian men and women compared to a control group not consuming fatty fish? c. Does~     consumption of nuts improve markers of cardiometabolic risks in overweight and obese adult~     Norwegian men and women compared:1. to a control group not consuming nuts or fatty fish and~     2. to a group consuming fatty fish.~      Clinical significance of study: If an increase in POP levels is seen, and correlates with~     cardiometabolic risks, this may indicate the need to look further at a causal relation~     between POPs and cardiometabolic disease and risk factors particularly type 2 diabetes. If~     eating nuts improves CVD risk factors compared to not eating nuts, or to eating fatty fish,~     this could be important dietary information for populations at high risk of CVD.~   "
74654|NCT02589743|"~     This study assessed long-term impact of tooth Eruption Stages (ES) on sealant retention on~     occlusal surfaces previously coated with intermediary bonding layer and it determined caries~     incidence outcome evolved. The treatment were (sealant/technique): Fluroshield; Helioseal~     Clear Chroma; Single Bond and Fluroshield; Excite and Helioseal Clear Chroma.~   "
74655|NCT02589730|"~     The purpose of this study was to explore a model suitable for the individualized diabetic~     management based on the mobile application coaching and demonstrate its effect among the~     diabetic mellitus population.~   "
74656|NCT02589717|"~     This is an open-label, multicenter, single-arm, expanded access program (EAP) designed to~     provide atezolizumab access to participants with locally advanced or metastatic urothelial~     carcinoma that has progressed on, or is intolerant to, a platinum-containing chemotherapy~     regimen.~   "
74657|NCT02589704|"~     This is a single visit, non-interventional, cross sectional study about risk factors,~     etiology, nutritional status and feeding methods in CP patients.~   "
74658|NCT02589691|"~     The prevention of the occurrence of respiratory events is a constant concern in pediatric~     anesthesia, as these represent the main cause of the anesthesic mortality. These events occur~     partly during induction of anesthesia and are all the more frequent as the child is young.~      The French recommendations do not propose the use of neuromuscular-blocking agents in~     pediatric anesthesia. This recommendation is controversial In a recently published study, it~     has been shown that the use of neuromuscular blocking agents during induction in children~     under 2 years improves intubating conditions and reduces the incidence of hemodynamic and~     respiratory events. This monocentric study, centered on intubating conditions, does not allow~     to conclude on the influence of muscle relaxants on reduction of the respiratory morbidity.~      The objective of study is to demonstrate that, in children under 2 years, changing the~     anesthesia protocol can reduce the incidence and severity of episodes of hypoxemia associated~     with respiratory events occurring during induction~   "
74659|NCT02589678|"~     Participants will receive vaccination for measles, mumps, and rubella (MMR) and tetanus,~     diphtheria, pertussis, and inactivated polio (Tdap-IPV). The study schedule design is to~     simulate a vaccine efficacy trial to see if single women can participate in studies that~     mimic actual HIV vaccine studies.~   "
74660|NCT02589665|"~     The main purpose of this study is to test the hypothesis that treatment with mirikizumab is~     superior to placebo in providing clinical benefit to participants with moderate to severe~     ulcerative colitis (UC). This study will also investigate how the body processes the drug.~   "
74661|NCT02589652|"~     This is a multicenter, prospective cohort study to evaluate the efficacy and safety of~     sequential combination or switch therapy of pegylated interferon alfa-2a in chronic hepatitis~     B patients with low HBsAg and HBeAg titers after long-term entecavir therapy, and compared to~     those who continued on ETV therapy.~   "
74662|NCT02589639|"~     This is a multi-center, randomised, double-blind, placebo-controlled, parallel-group,~     efficacy and safety study of empagliflozin as add-on to insulin in Japanese patients with~     Type 2 Diabetes Mellitus with insufficient glycaemic control~   "
74663|NCT02589626|"~     This is a multi-center, randomised, double-blind, parallel-group, safety and efficacy study~     of empagliflozin as add-on to GLP-1 RA in Japanese patients with Type 2 Diabetes Mellitus~     with insufficient glycaemic control~   "
74664|NCT02589613|"~     The objective is to investigate neuro-anatomical correlates of the regulation of energy~     intake by means of functional MRI. Administration of glucose as well as fructose is followed~     by functional brain MRI, and findings are correlated with serum glucagon-like peptide 1~     (GLP-1) levels as an endogenous satiety signal in obese humans.~   "
74665|NCT02589600|"~     The goal of this study is to perform the first fracture reduction clinical trial with a~     potent antiresorptive agent (intravenous zoledronic acid) in the most vulnerable long-term~     care population.~   "
74666|NCT02589587|"~     Morbidly obese patients exhibit impaired secretion of satiation hormones which may contribute~     to the development of obesity. Bariatric surgery is associated with weight loss and dramatic~     increase in the secretion of satiation hormones, but the underlying mechanism remains~     unknown. The investigator's goal is therefore to examine patients before and after sleeve~     gastrectomy and compare findings to lean controls.~   "
74686|NCT02589327|"~     Excessive cardiac fat accumulation have been recognized to be associate to increased cardiac~     and metabolic risk. The aim of this study the effects of exercise in cardiac fat content,~     cardiac function, physical fitness, and metabolic activity in obesity.~   "
74687|NCT02589314|"~     This study will evaluate if periodontal mechanical treatment is capable to alter~     immunological and genetical parameters related to systemic health in patients with chronic~     periodontitis ant diabetes type 2.~   "
74667|NCT02589574|"~     Influenza is an important cause of medical visits and worker absenteeism among healthy~     adults. Studies of healthcare providers vaccination programmes have reported a positive~     effect in lowering rates of influenza like illness and influenza related complication,~     hospitalisation and death. Nurses should receive influenza vaccination so that those patients~     who may come in contact with will not be infected by their nurses. However, the immunization~     rate among nurses is constantly low. Therefore, it is important to develop an intervention~     programmes to increase immunization of nurses. In some research on electronic text messaging~     in promoting public health showed potential of this communication system in preventive health~     behavioural change. With the use of this widely acceptable, accessible and convenient~     approach of communication, reminders of receiving influenza vaccination are sent to nurses~     involved in this study. At the same time, educational messages are sent to modify their~     perception on the positive effect of influenza vaccination, and therefore, motivate the~     nurses to receive the vaccination. The study will be conducted as a two-arm randomised~     controlled trial which the control and intervention groups will run concurrently. Nurses of a~     local hospital are invited to participate in this study. They will receive the usual~     announcement on the information of free influenza vaccination of the hospital. The~     participants of the intervention group will also receive text message reminders on details~     for free influenza vaccine and educational information. All communication occurred through~     secure, asynchronous electronic text messages. The reminders and educational information are~     developed with reference to promotion messages from the Department of Health under the~     framework of Health Belief Model so as to promote positive perception on influenza~     vaccination by the participants. Participants are invited to complete the pre and post~     questionnaires before and after the study period. The influenza vaccination status of the~     participants and their perception on influenza vaccination will be obtained. It is~     hypothesised that the participants receiving the reminders and educational information will~     more likely to receive influenza vaccine and perceived the influenza vaccination as important~     measure in protecting them from influenza. The participants of the intervention group will~     also receptive to electronic text messaging communication and education.~   "
74668|NCT02589561|"~     Currently, the fitting of hearing aids is using a computer interface that allows to adjust~     the gain and compression of acoustic amplification. This adjustment is made face to face,~     patient and audiologist being located in a soundproof space to test the effectiveness of the~     hearing aid.~      However, advances in telemedicine in this context, let consider the possibility of addressing~     these hearing aids fitting via the same computer interface, but remotely controlled by the~     hearing care professional. The purpose of this study is to assess the ability to perform~     these tests no longer in front of the patient settings, but away from it, and without visual~     and sound contact other than through a computer interface.~      At the end, this project wants to show that a remote fitting is an acceptable procedure that~     provides comparable results to-face fitting in terms of speech perception, speech in noise~     audiometry, hearing loss related quality of life in order to be able to offer this type of~     strategy.~   "
74669|NCT02589548|"~     The study is a prospective registry of Hodgkin Lymphoma (HL) patients in Brazil.~      The purpose of the study is to gather clinical, epidemiologic and outcomes data on the~     treatment of HL, on the basis of records collected by key Brazilian institutions, through a~     centralized web-based registry of clinical data verified by central board of~     hematopathologists.~   "
74670|NCT02589535|"~     Septic shock is a systemic inflammatory response syndrome with acute circulatory failure~     secondary to a documented infection. It is the most feared complication in ICU patients, with~     a 50% mortality rate.~      The study of stem cells and their experimental use in sepsis treatment is particularly~     relevant in the international scientific research, where Italy plays an important role. In~     the vast and complex field of stem cell research, the primary aim of the current proposal is~     to evaluate the time course level of circulating endothelial progenitor stem cells CD34 + /~     CD133 + (EPCs), and some factors EPCs-related, such as hypoxia- inducible factor (HIF- 1) and~     stromal derived factor-1 (SDF-1) in septic patients undergoing major abdominal surgery.~      Secondary objective 2: to investigate the relationship between CD133/CD34, HIF-1, SDF-1a and~     outcome of septic/septic shock patients treated with standard conventional therapy alone (CT)~     or with extracorporeal hemoperfusion therapy (HCT).~   "
74671|NCT02589522|"~     This phase I trial studies the side effects and best dose of ATR kinase inhibitor VX-970~     (VX-970) when given together with whole brain radiation therapy in treating patients with~     non-small cell lung cancer, small cell lung cancer, or neuroendocrine tumors that have spread~     from the original (primary) tumor to the brain. ATR kinase inhibitor VX-970 may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation~     therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving ATR kinase~     inhibitor VX-970 together with radiation therapy may be a better treatment for non-small cell~     lung cancer, small cell lung cancer, or neuroendocrine tumors.~   "
74672|NCT02589509|"~     The purpose of this study is to test an innovative combination of direct-attention training~     and metacognitive training in the treatment of attention impairments in Veterans with~     moderate-to-severe traumatic brain injury (TBI) who report experiencing attentional problems.~     Enrolled participants will be randomized to receive either the direct-attention training or~     metacognitive training first and then will be crossed over to receive the opposite~     intervention. The study will consist of two treatment periods of 4 weeks and a post-treatment~     4 weeks later. In addition to the rehabilitation treatments, participants will also perform~     measures of complex functional activities (e.g., independent activities of daily living or~     IADLs) and neurocognitive tests of attention-control functions. Participants will also~     perform an attentional task that probes the function of three different attentional systems~     while brain wave activity (i.e., electroencephalography or EEG) is being recorded in order to~     assess changes in brain function that may be improved by the rehabilitation approach. Planned~     enrollment will be 36 Veterans.~   "
74688|NCT02589301|"~     This study will evaluate the pharmacokinetics (relative bioavailability) and~     pharmacodynamics, after single subcutaneous application, in healthy volunteers of both sexes,~     between pegfilgrastim formulation, produced by Eurofarma Laboratorios S/A and Neulastim®~     (reference formulation), marketed by Produtos Roche Químicos e Farmacêuticos S/A.~      In addition to that, a pharmacodynamics comparison will be performed, through change in~     absolute neutrophil count in leukogram performed in the same time of pharmacokinetics~     analysis collection and through CD34+ cell count in peripheral blood at timepoints 0:00,~     96:00 and 384:00 hours.~   "
74689|NCT02589288|"~     The aim of this prospective, randomized , blinded study is to compare two different infusion~     techniques (continuous VS intermittent automatic bolus) to assess the effects of~     postoperative analgesia after Day-Case anterior cruciate ligament (ACL) reconstruction.~   "
74690|NCT02589275|"~     This is a Phase 3, open-label, extension trial designed to evaluate the long term safety and~     efficacy over 3 months of TNX-102 SL tablets taken daily at bedtime for the treatment of~     Fibromyalgia (FM). Patients recruits into this trial are those who have successfully~     completed the double-blind studies; TNX-CY-F301 and TNX-CY-F302. Anticipated start for~     TNX-CY-F302 is for March 2016.~      Patients will not be made aware of the therapy they received during the double-blind study.~   "
74673|NCT02589496|"~     Gastric cancer (GC) is the second most common cause of cancer related mortality and the~     fourth most common cancer worldwide. The molecular classification of GC and the relevance of~     pre-clinical models are not well established, creating challenges in discovering novel~     molecularly targeted therapies. In order to address these issues, we conducted an integrated~     molecular data analysis of three hundred Asian Gastric tumors through the Asian Cancer~     Research Group (ACRG). We performed an integrated genomic analyses based on target~     sequencing, gene expression profiling, copy number variations, Lauren's histological~     classification, Epstein Barr Virus (EBV) status, TP53 status in three hundred GC specimens.~      We first divided GC into four subgroups based on gene expression profiling and TP53 status:~        1. epithelial MSS-TP53 inactive;~        2. epithelial MSS-TP53 active;~        3. MSI; and~        4. mesenchymal.~      With an integrative analysis with target sequencing and copy number variations, epithelial~     MSS-TP53 inactive GCs are characterized by predominantly hypermutated intestinal tumors~     (including majority of mutations in KRAS) with MLH1 loss through promoter methylation and~     MSS-TP53 active GCs are characterized by intact TP53 pathway with high frequency of EBV~     infection or frequently mutated oncogenes (e.g. PIK3CA). MSI subtype with TP53 pathway~     inactive characterized by TP53 loss through deleterious mutations in TP53 or MDM2~     amplification and further characterized by both focal amplifications in oncogenes such as~     HER2, EGFR, cMET, CCNE1 as well as large scale chromosomal gains and losses. The above~     subtypes exhibited differential prognosis with the mesenchymal subtype displaying the worst~     survival (2.2 years) and the MSI subtype the most favorable survival (5.6 years). The GC~     subtypes and their association with prognosis were independently validated in three GC~     cohorts. We additionally showed significant association of global gene expression immune~     patterns, like adaptive immune system and inflammation, as well as expression of PD-L1, with~     the genomic defined subtypes.~      In the phase Ib KEYNOTE-012 study which evaluated pembrolizumab monotherapy at 10 mg/kg ever~     2 weeks in patients with gastric cancer were recently reported. Most patients had two or more~     prior lines of therapy. In the study, 41% of evaluable patients showed tumor shrinkage. The~     overall response rate in 39 patients were 31%.~      The preliminary data showed a Not significant correlation between PD-L-1 expression and ORR~     (P=0.071).~      Given the mutual association of tumor genetic markers, gene expression and potential markers~     of response to immune therapy identified through the collaborative work between SMC and MERCK~     MSD and Lilly, we plan to perform a phase II study with integrative genomic analysis (whole~     exome and RNA sequencing) in pre and post biopsy specimens to better define those GCs who may~     benefit from pembro.~   "
74674|NCT02589483|"~     The anastomotic leaks are multivariable in its origin. The incidence varies among different~     centers between 4% and as high as 25%. The impact of leakage in a rectal anastomosis can be~     devastating for the patient and very costly for the health care system.~      Prolonged hospital stay (LOS), invasive treatment and intensive care are the consequences.~      The future of colorectal surgery will increasingly include older patients with increased~     preoperative morbidity and probably even higher risk for anastomotic leaks. which makes it~     suitable for reinforcing a rectal anastomosis. The goal is to shift the clinical leaks~     spectrum into a subclinical and therefore self-healing one.~   "
74675|NCT02589470|"~     Studies on the cognitive function have highlighted promising results concerning attention. In~     contrast, in the field of memory, the single cohort study that has been carried out, has not~     been randomised, with non comparable groups, the significant outcomes are therefore to be~     balanced.~      In this study, patients with focal and structural temporal lobe epilepsy will be randomised~     in 2 groups : the COMETE group where patients will attend a specific rehabilitation programme~     of memory and the control group where patients will benefit from a standard treatment.~   "
74676|NCT02589457|"~     The purpose of this study is to compare the safety and pharmacokinetics of CKD-390(Tenofovir~     Disoproxil Aspartate) and Viread® tablet(Tenofovir Disoproxil Fumarate) in healthy male~     volunteers.~   "
74677|NCT02589444|"~     The objective of this study is to assess the effects of a high-dose vitamin D3 on the~     composition of gut and lung microbiota in adolescents and adults with cystic fibrosis who are~     vitamin D deficient.~   "
74678|NCT02589431|"~     Background: The purpose of the present study was to compare serum total cortisol (STC),~     salivary cortisol (SaC) and calculated free cortisol (cFC) levels at the baseline and after~     the ACTH stimulation test, in patients with severe sepsis (SS) and to determine the~     suitability of SaC and cFC levels instead of STC for the diagnosis of adrenal insufficiency~     in patients with SS.~      Methods: Thirty patients with SS (15 men, and 15 women) were compared with 16 healthy~     controls. Low dose ACTH stimulation test (1 µg) was performed on the first, 7th and 28th days~     of diagnosis of SS. STC and SaC levels were measured during ACTH stimulation test.~   "
74679|NCT02589418|"~     The investigators will assess the effects of manual acupuncture on experimental dental pain~     in 36 healthy subjects by means of subjective pain intensity ratings and pain-specific~     autonomic nervous system (ANS) reactions.~   "
74680|NCT02589405|"~     The aim of this study is to evaluate a complete acne regimen consisting of a medication~     (Benzaknen® 5% Gel), and 2 cosmetic products Dermotivin® Soft Liquid soap and Cetaphil®~     Dermacontrol Moisturizer SPF30 in patients with acne.~   "
74681|NCT02589392|"~     The purpose of this study is to evaluate the effect of Cetaphil® Restoraderm® skin restoring~     moisturizer in reducing the signs and symptoms of very dry atopic skin in young children.~     Subjects with atopic dermatitis (AD) in remission phase will be randomized to receive either~     Cetaphil® Restoraderm® skin restoring body wash only, or the same body wash in association~     with Cetaphil® Restoraderm® skin restoring moisturizer.~   "
74682|NCT02589379|"~     The purpose of this study is to assess the value of preoperative objective modalities such as~     endoscopic ultrasound elastography and magnet resonance imaging in predicting development of~     postoperative pancreatic fistula in patients undergoing pancreatic surgery for benign or~     malignant disease.~   "
74683|NCT02589366|"~     Part of standard treatment for endometrial cancer is to remove one or more groups of lymph~     nodes (lymph node dissection). Lymph nodes are small, bean-shaped organs located within the~     body throughout the lymphatic system (the tissues and organs involved in immunity, which aids~     in the fight against infection and cancer).~      The purpose of this study is to compare the safety and ability of Lymphoseek and a Vital Blue~     Dye (tracing agent) to find lymph nodes that may carry cancer from the tumor through the~     lymphatic system. Lymphoseek will be injected into the tumor on the day before surgery to~     remove lymph nodes. Vital Blue Dye will be administered during surgery to trace the cancer as~     well. The surgeon will remove the lymph nodes as part of routine surgery and will keep track~     of which lymph nodes are identified by Lymphoseek and Vital Blue Dye. These nodes will be~     sent to another doctor to view them under a microscope and see if the nodes contain cancer~     cells.~      The hypothesis is that Lymphoseek can be used safely and will be at least as effective as~     blue dye in identifying the lymph nodes that may have cancer cells.~   "
74710|NCT02589015|"~     The aim of this study is to determine the correlation of neck circumference with difficult~     mask ventilation and laryngoscopy in morbidly obese patients.~   "
74711|NCT02589002|"~     In this study the effects of sucralose on insulin sensitivity, beta-cell response and~     appetite regulating hormones will be evaluated.~   "
74712|NCT02588989|"~     The aim of this project is to better evaluate the systemic right ventricular (RV) function in~     patients with transposition of the great arteries (TGA).~   "
74691|NCT02589262|"~     The study medicine is a potential future treatment for schizophrenia, an illness that affects~     the way that people think, feel or behave. It is not clear what causes schizophrenia, but~     it's been linked to chemical imbalance in the brain. It is hoped that the study medicine will~     activate specific sites in the brain to help correct that imbalance. Current treatments for~     schizophrenia don't work very well and can cause unpleasant side effects. It is hoped that~     the study medicine will work better, and have fewer side effects than existing medicines.~      In this 2 part study (Parts A and B), the primary aim is to assess how safe the study~     medicine is in healthy men, aged 18-45 years, and how much of it gets into the blood. Its~     effects on the brain will also be tested.~      In Part A, up to 24 participants will receive up to 5 single doses of the study medicine~     (AUT00206 or placebo) by mouth, either after fasting or after a high fat breakfast. The study~     medicine has never been given to humans before, so the initial doses will be small and the~     dose level will be increased as the study progresses. Participants may take up to 14 weeks to~     finish the study. They'll make up to 22 outpatient visits, and stay on the ward up to 5~     times, for 3 nights in a row each time.~      In Part B, 24 participants will receive daily doses of the study medicine (AUT00206 or~     placebo) for up to 28 days. Participants will take up to 10 weeks to finish the study.~     They'll make 6 outpatient visits, and stay on the ward for up to 30 nights, depending on how~     long we expect it to take until blood levels of the study medicine level off.~      A pharmaceutical company, Autifony Therapeutics Limited, is funding the study. The study will~     take place at 1 centre in London.~   "
74692|NCT02589249|"~     The purpose of this 12-week, prospective study is to determine the effects of oral~     supplementation with AyuFlex® (an over-the-counter dietary supplement) on joint mobility,~     joint comfort and functional capacity in healthy overweight subjects.~   "
74693|NCT02589236|"~     This will be a double-blind, randomized, placebo-controlled, parallel group study. The~     purpose of this study is to investigate the efficacy and safety of Cavosonstat (N91115) in~     adult patients with CF who are homozygous for the F508del-CFTR mutation and being treated~     with lumacaftor/ivacaftor (Orkambi™).~   "
74694|NCT02589223|"~     St. Michael's Hospital (SMH) provides service to individuals with some of the most severe~     brain injuries and intensive care needs in Canada. These patients often require prolonged~     intensive care admissions, lengthy hospital stays, involvement of many health professionals,~     and long-term support for ongoing care requirements. Many hospitals face resource~     limitations, specifically involving the health disciplines and their ability to provide~     frequent intervention.~      It has been proposed that multisensory stimulation (i.e. exposing the patient to various~     sights, sounds, smells, etc.) in the early stages of brain injury recovery may result in~     improved responsiveness/cognitive function.~      Previous research has indicated a potential benefit for early multisensory stimulation~     intervention for patients with severe brain injury. However there is still not enough~     conclusive evidence to confirm whether the intervention is truly effective. The investigators~     are proposing a pilot randomized controlled study (placebo-controlled, double-blinded) to~     determine the feasibility and examine the effectiveness of early multisensory stimulation~     with patients following severe brain injury who remain in a coma, vegetative state, or~     minimally conscious state. Eligible patients will be randomized to a control group (standard~     care + family/caregiver education) or an intervention group (standard care + family/caregiver~     education + early sensory intervention). Data regarding number of patients enrolled, amount~     of intervention completed, percentage of outcome data collected, patient's level of~     responsiveness and cognitive function will be collected before and after the intervention~     period, using several outcome measures. The investigators hope to determine the feasibility~     of conducting this type of study within this clinical setting and the effectiveness of~     multisensory stimulation with this patient population.~   "
74695|NCT02589210|"~     A single-centered, non-randomized study with approximately 20 subjects that will be seen for~     up to 12 weeks, each receiving the EpiFix mesh plus standard of care. Safety and~     effectiveness will be monitored throughout the study.~   "
74696|NCT02589197|"~     MicroPort Orthopedics (MPO) is conducting this study to build upon the results of a previous~     study which showed the Medial Pivot (MP) system required lower quadriceps activation than~     subjects implanted with a Posterior stabilized (PS) system preforming the same activities of~     daily living.~   "
74697|NCT02589184|"~     Determine if adding extra-gravity (sustained increase in vertical loading) during standard~     rehabilitation exercises has a beneficial effect on pain reduction in subjects suffering from~     shoulder pain of different origin.~   "
74698|NCT02589171|"~     The purpose of this study is to compare the neoClose abdominal closure to the standard~     Carter-Thomason closure in a bariatric surgery gastric bypass population.~   "
74699|NCT02589158|"~     The purpose of this study is to look at the levels of three HIV medications: atazanavir,~     darunavir and cobicistat in the blood after drug intake has been stopped, in order to~     understand how long these drugs persist in the blood. The study will specifically look at~     blood levels of these three drugs after taking them every day for 10 days. Participants will~     take Evotaz (atazanavir and cobicistat) on a first stage and Rezolsta (darunavir and~     cobicistat) on a second stage.~      If the participants decide to take part, the duration of the study will be up to 33 days plus~     a screening visit which will take place up to 28 days prior to the start of the study, and a~     follow up visit, which takes place 7 to 14 days after the last dose of study medication. This~     study is not randomised which means that all participants will receive all study medications~     in the same order.~      The participant and the study doctor will know which study medications the participant is~     taking at all times during the study.~   "
74700|NCT02589145|"~     The goal of this clinical research study is to find the highest tolerable dose of~     lenalidomide that can be given in combination with vorinostat, gemcitabine, busulfan, and~     melphalan, with a stem cell transplant, and with or without rituximab. Researchers also want~     to learn about the safety and effectiveness of this combination.~   "
74701|NCT02589132|"~     Failure to Thrive negatively affects growth, cognition, behavior, and quality of life (QoL),~     which can be devastating and enduring. These outcomes are high-cost and lead to increased~     family stress and negatively affect the caregiver-child relationship. Therefore, families~     need increased access to materials that will help them understand their child's health and~     help them use new feeding behaviors to improve the child's nutrition and growth. Standard~     care with the addition of Mobile Thrive (M-Thrive), our innovative smart phone-based mobile~     app, is intended to demonstrate the clinical advantages of using mobile health technology~     (mHealth) in comparison to standard care alone.~   "
74748|NCT02588521|"~     This randomized, double-blind, placebo-controlled, 4 part study will assess the safety,~     tolerability, pharmacokinetics and antiviral activity of orally administered AL-794 in~     healthy volunteers (HV).~   "
74865|NCT02586987|"~     This is a Phase I, open-label, multi-centre, drug combination study of double and triple~     combination oral selumetinib (AZD6244 Hyd-sulfate) plus intravenous (IV) MEDI4736 and oral~     selumetinib plus IV MEDI4736 and IV tremelimumab in patients with advanced solid tumours.~   "
74702|NCT02589119|"~     The investigators propose to study the safety of autologous mesenchymal stromal cell transfer~     using a biomatrix (the Gore Fistula Plug) in a Phase I study using a single dose of 20~     million cells. 15 adult patients, ages 18 years and older with cryptoglandular fistulas will~     be enrolled. Subjects will undergo standard adjuvant therapy including drainage of infection~     and placement of a draining seton. Six weeks post placement of the draining seton, the seton~     will be replaced with the MSC loaded Gore Fistula Plug; fistula plug as per current clinical~     practice. The subjects will be subsequently followed for fistula response and closure for 24~     months. This is an autologous product derived from the patient and used only for the same~     patient.~   "
74703|NCT02589106|"~     One of the most common types of 3-dimensional spinal deformities with unknown etiology in~     youths is adolescent idiopathic scoliosis (AIS). The spinal curvature increases as puberty~     progresses. Generally, rigid orthotic bracewear is prescribed as non-invasive treatment for~     moderate AIS if treatment begins early and the orthosis is worn with compliance. Obviously,~     teenage patients are reluctant to accept a rigid orthosis due to aesthetics and the physical~     constraint. Therefore, semi-rigid and flexible orthoses have been developed, but their~     efficacy is still controversial and there are other issues, such as high pain scores. There~     is clearly room for improvement. Therefore, a garment-type of bracewear will be designed and~     developed to correct spinal deformity, reduce the possibility of spinal curve progression,~     and satisfy the needs of the patients as well as take their psychological concerns into~     consideration.~   "
74704|NCT02589093|"~     Anesthesiology daily practice consists in management of sedation, immobility and analgesia.~     The monitoring of this last component remains largely based on indirect signs with poor~     sensitivity and specificity such as heart rate and blood pressure. Accordingly, there is an~     increased demand for more accurate analgesia monitors. Several parameters have been studied~     in the recent years such as spectral entropy, skin conductance, pupillometry or heart rate~     variability (HRV). The HRV is influenced by the balance of sympathetic and parasympathetic~     tones, and is therefore influenced by pain and analgesia.~      MDoloris Medical Systems SAS, located in Lille, France, had developed a monitor called~     PhysioDoloris (TM) that uses an analysis of the HRV to generate a clinically useable index,~     the Analgesia-Nociception Index (ANI). The ANI varies from 0 to 100, a lower number~     indicating less parasympathetic tone. It has been shown in previous studies under general~     anesthesia to decrease at the moment of surgical incision and pneumoperitoneum inflation and~     to increase with opioids administration.~      The purpose of this study is to show a correlation between the variation of the ANI with pain~     scores in awake healthy volunteers who are subjected to standardized painful stimuli of~     increasing intensity. The investigators hypothesize that an increasing pain score will~     correlate with decreasing ANI values.~   "
74705|NCT02589080|"~     Amputation of a limb may result from trauma or surgical intervention. The amputation~     traumatically alters the body image, but often leaves sensations that refer to the missing~     body part. In 50-80% amputees, neuropathic pain develops, also called phantom limb pain~     (PLP). Both peripheral and central nervous system factors have been implicated as~     determinants of PLP. Also, PLP may be triggered by physical (changes in the weather) and~     psychological factors (emotional stress). Recent evidence suggests that PLP may be~     intricately related to neuroplastic changes in the cortex, and that these changes may~     modulated by providing sensory input to the stump or amputation zone.~      A non-invasive clinical trial will test the effectiveness of non-invasive pressure sensory~     feedback build into a hand prosthesis to alleviate phantom limb pain.~   "
74706|NCT02589067|"~     The problem of interest is the high rate of recurrent SSTIs in children caused by S. aureus~     despite the use of systemic antibiotic treatment, due to difficulties in decolonization and~     the prevalence of antibiotic-resistant strains such as MRSA.~      This problem will be studied through a randomized, double-blind, placebo-controlled clinical~     trial of the use of a 0.12% clorhexidine gluconate (CHG) oral rinse in decolonizing S. aureus~     in the oropharynx in children 5-17 years old. CHG is an excellent candidate for use in~     children as its safety has been widely established, and it is readily commercially available.~     Eligible, consented subjects will be asked to participate in a baseline study visit in which~     swabs of their oropharynx and nares are obtained, and they are educated on the use of either~     CHG oral rinse or a placebo oral rinse containing saline. The subjects will be instructed to~     perform the oral rinse twice daily for seven days. Two follow-up visits will occur at 7 and~     28 days post-baseline, where subjects' nares and oropharynx are again swabbed in order to~     ascertain short- and long-term decolonization of S. aureus. This procedure will serve to 1)~     determine the efficacy of a CHG oral rinse in decolonization of S. aureus, 2) investigate the~     safety, tolerability, and compliance of oropharyngeal decolonization among children and their~     caregivers, and 3) determine the genetic backgrounds of strains of S. aureus associated with~     continued colonization.~   "
74707|NCT02589054|"~     Ultrasound-guided regional anesthesia is increasingly being used in the modern surgical~     environment to provide specific intraoperative anesthesia and postoperative analgesia.~     Infiltration of local anesthesics around peripheral nerves firs blocks sympathetic, then~     sensory, then motor nerve function. Sympathectomy-induced vasodilation following brachial~     plexus block results in increased skin temperature and arterial flow within minutes.~      Although it has not been shown to reliably increase diameter or cross-sectional area of~     distal arteries, brachial plexus block does change the pattern and quantity of blood flow to~     the hand. Given that the magnitude of change of flow cannot be attributed to vessel radius,~     the investigators suspect that the more laminar fluid dynamics are due to vascular tone.~      The investigators study aims to quantify alterations in physiology and peripheral vasodilator~     response. The investigators anticipate that axially block will significantly improve regional~     blood flow.~   "
74708|NCT02589041|"~     This prospective, double-blinded study evaluates intraneural ropivacaine 1% Minimal Effective~     Volume (MEV90) for ultrasound-guided (US) popliteal sciatic nerve block, with Up-and-down~     methodology.~      To evaluate any neurological complications, an electrophysiological assessment will also be~     performed preoperatively and at 5 weeks after surgery.~   "
74709|NCT02589028|"~     The aim of this study is to explore premeal protein-enriched bar effect in postprandial~     glucose levels and concentration of plasma incretin hormones [glucagon-like peptide 1 (GLP-1)~     and/or glucose-dependent insulinotropic polypeptide (GIP)] in healthy subjects and those with~     type 2 diabetes.~   "
74713|NCT02588976|"~     The SONOCLOT Analyzer (S1; Sienco, Inc. Boulder, CO USA, Model DP-2951) is used to perform~     kaolin-based activated clotting time as routine monitor of heparin therapy in patients~     undergoing cardiac operations. In addition, the device allows the assessment of the patient's~     coagulation status by a glass-bead activated test. Recently, a new SONOCLOT analyzer (S2) has~     been developed. As part of the routine management using S1, tests are also performed on S2.~     Results are entered into the cardiac surgery data base of all cardiac surgery patients and~     analyzed.~   "
74714|NCT02588963|"~     The aim of this study is to evaluate the influence of Primary and Secondary Prevention of~     Respiratory Infections in children up to 3 years-old attending daycare.~   "
74715|NCT02588950|"~     This purpose of this two-part study is to measure how much of the study drug gets into the~     blood stream and how long it takes the body to get rid of it. In Part A, each participant~     will receive two treatments, a single dose and a continuous dose of U-500R insulin, both~     administered just under the skin. Participants who complete Part A will continue into Part B~     where they will be assigned to 1 of 2 treatments with U-500R insulin, injected either twice~     or three times daily under the skin for 5-10 days. This study can last from 7-14 weeks~     including initial screening and follow up.~   "
74716|NCT02588937|"~     The purpose of this study is to evaluate the antiviral activity and safety of EntecaBell ODT.~     in chronic hepatitis B Patients.~   "
74717|NCT02588924|"~     The Department of Experimental Medicine - Section of Hygiene, Occupational Medicine, Forensic~     Medicine of the Second University of Naples, the Section of Neurology of the Second~     University of Naples and the Mediterranean Neurological Institute NEUROMED, IRCCS are~     involved in the realization of a research project aimed at studying the correlation between~     environmental and occupational exposure to metals (copper, iron and manganese) and Parkinson~     disease in order to increase the knowledge of these possible risk factors and highlight an~     eventual predictive-diagnostic meaning of possible discrepancies in the content of these~     elements; secondly the collected data could be used for assessing the association (odd~     ratio-OR) between pathologies and different risk factors (for example smoking habits,~     professional exposure and so on).~   "
74718|NCT02588911|"~     The current study was a double blind randomised controlled trial that compared radiofrequency~     ablation (RFA) versus conventional surgery (CS) in patients who served as their own controls~     and who had intact great saphenous veins (GSVs).~   "
74719|NCT02588898|"~     This case-control study investigated B-vitamin and homocysteine in relation to the presence~     or the absence of type 2 diabetes and clinical signs of polyneuropathy.~   "
74720|NCT02588885|"~     This project will develop and preliminarily examine RESPECT, a trauma-sensitive psychological~     and physical therapy intervention to treat chronic pelvic pain, posttraumatic stress symptoms~     (PTS), and dysfunctional sexual behavior among women with sexual abuse histories. Patients~     will be recruited after being referred to pelvic floor physical therapy for treatment of~     chronic pelvic pain. Participants will complete seven sessions of individual cognitive~     behavioral psychotherapy. Physical therapy will be provided by clinicians who have been~     trained in trauma-sensitive treatment techniques. Treatment acceptability and outcomes will~     be assessed at baseline, mid intervention, post-intervention and follow-up via self-report~     measures. The RESPECT protocol is expected to be feasible to implement among sexual abuse~     survivors and to be well liked by patients. RESPECT is expected to reduce chronic pelvic~     pain, PTS, dysfunctional sexual behavior, treatment avoidance.~   "
74721|NCT02588872|"~     In this, prospective, double-blind study, patients with mild to moderate symptomatic knee~     osteoarthritis will be randomized to receive either a series of leukocyte poor, platelet-rich~     plasma or hyaluronic acid injections under ultrasound guidance. Clinical data in the form of~     subjective outcome measures will be collected pre-treatment and at four time intervals across~     a 1-year period. Synovial fluid will also collected for analysis of pro- and~     anti-inflammatory markers pre-treatment, and at 12 and 24 weeks.~   "
74722|NCT02588859|"~     This is a multicentre, non-interventional, prospective, observational study which would be~     conducted in India to understand the usage and effect of saxagliptin as first add-on therapy~     after metformin. The study will enroll Type 2 Diabetes Mellitus (T2DM) patients who were~     inadequately controlled with metformin alone and have been recently prescribed saxagliptin as~     an add-on to metformin.~   "
74723|NCT02588846|"~     Assessing the feasibility of implementing real-time multi-leaf collimator (MLC) tracking to~     account for the relative motion of the moving prostate tumour target and the static pelvic~     nodal target for high-risk prostate cancer patients. The capability of tracking for the~     relative motion of multiple targets will ensure that all the treatment targets receive~     correct dose as prescribed by the doctor and minimise side effects to the critical organs.~   "
74724|NCT02588833|"~     The objectives of the study are to assess the safety, tolerability, preliminary efficacy and~     PK of multiple subcutaneous (SC) doses of APL-2 in subjects with paroxysmal nocturnal~     hemoglobinuria (PNH) who have not received treatment with eculizumab in the past.~      An exploratory objective of the study is to assess the pharmacodynamics (PD) of multiple SC~     doses of APL 2 when administered to PNH patients.~   "
74725|NCT02588820|"~     Pilot study to evaluate the impact of extremely early ART in the dynamics of viral reservoir,~     immune activation and inflammation in patients with HIV-1 infection of less than 20 days~     (Fiebig stages I-II) compared to patients with infection of 20-100 days (Fiebig stages~     III-V), to induce HIV functional cure.~   "
74726|NCT02588807|"~     The purpose of the study is to evaluate the safety of combining phospholipids with medicinal~     plants for treatment of patients with amyotrophic lateral sclerosis (ALS)~   "
74727|NCT02588794|"~     Aim of the study is to reduce the incidence of RIFLE stadium L and E after acute kidney~     injury in patients with severe sepsis/septic shock~   "
74749|NCT02588508|"~     This study evaluates the effectiveness of warm packs, perineal massage and hands off, during~     labour, in the perineal outcomes. The perineal outcomes are perineal tears, grade of perineal~     tears, need of suture, perineal edema, perineal pain, use of drugs for perineal pain, and~     satisfaction with the technique used.~   "
74782|NCT02588079|"~     The purpose of this study is to determine whether internet-based cognitive behavioral therapy~     (ICBT) is effective in the treatment of children and adolescents with dental anxiety. The~     investigators hypothesis is that children and adolescents who have been offered ICBT show~     significant better performance on outcome measures compared with patients in control group.~   "
74728|NCT02588781|"~     Pemetrexed is an anticancer agent that exerts its action by disrupting crucial~     folate-dependent metabolic processes essential for cell replication. In vitro studies have~     shown that pemetrexed behaves as a multitargeted antifolate by inhibiting thymidylate~     synthase (TS), dihydrofolate reductase (DHFR), and glycinamide ribonucleotide~     formyltransferase (GARFT), which are key folate-dependent enzymes for the de novo~     biosynthesis of thymidine and purine nucleotides.Pemetrexed is used as a standard therapeutic~     agent for lung cancer, pleural mesothelioma, peritoneal mesothelioma.In addition to these~     effective anti-cancer effect, Pemetrexed is not severe side effects of the medicine.~      Pemetrexed has been research in colon cancer. Zhang, etc., demonstrated the anti-cancer~     effect of Pemetrexed in human colon cancer Cells.~      Although sometimes made also two or more clinical studies, Pemetrexed was reported 15-17% of~     the treatment response rate in these two studies.~   "
74729|NCT02588768|"~     Background/Aim: While growing evidence supports the use of photobiomodulation therapy (PBMT)~     for performance and recovery enhancement, there have only been laboratory-controlled studies.~     Therefore, the aim of this study was to analyze the effects of PBMT in performance and~     recovery of high-level rugby players during an anaerobic field test.~      Methods: It is a randomized, crossover, double-blinded, placebo-controlled trial. Twelve male~     high-level rugby athletes were recruited in this study. No intervention was performed before~     the Bangsbo Sprint Test (BST) at familiarization phase (week 1). At weeks 2 and 3,~     pre-exercise PBMT or placebo were randomly applied to each athlete. PBMT/placebo irradiation~     was performed at 17 sites of each lower limb, employing a cluster with 12 diodes (4 laser~     diodes of 905nm, 4 LED diodes of 875nm, and 4 LED diodes of 640nm, 30J per site -~     manufactured by Multi Radiance Medical™). Average time of sprints, best time of sprints, and~     fatigue index were obtained from BST. Blood lactate levels were assessed at baseline, and at~     3, 10, 30 and 60 minutes after BST. Athletes' perceived fatigue was also assessed through a~     questionnaire.~   "
74730|NCT02588755|"~     The aim of this study is to compare the outcomes of Transarterial Chemoembolization (TACE)~     plus Tegafur with TACE alone in patients with intrahepatic cholangiocarcinoma after curative~     resection~   "
74731|NCT02588742|"~     Delirium in older patients is associated with increased mortality and health care costs. And~     delirium is frequent in intensive care unit (ICU). Circadian rhythm alteration is one of the~     most important risk factor for developing delirium. In this study, investigators will~     investigate the effect of administration of melatonin on postoperative delirium in elderly~     ICU patients.~      Randomly selected patients of the melatonin group are given 5mg of melatonin in the evening~     from the day before surgery to the the 5th postoperation day. In contrast, patients in the~     control group are given placebo.~      Primary outcome of this study is the incidence of postoperative delirium measured by ICD-SC~     (Intensive Care delirium Screening Checklist). And secondary outcome includes~     intra-procedural hemodynamics measured by amount of used vasopressors, heart rate and blood~     pressure, total amount of sedatives, total amount of analgesics, duration of mechanical~     ventilation, duration of ICU stay.~      Thus, investigators perform this study to investigate the relationship between delirium and~     circadian rhythm.~   "
74732|NCT02588729|"~     In this study, the investigators will test a new way to communicate advice on diet and~     lifestyle to women with gestational diabetes mellitus by app downloaded on women`s~     smartphone. The app wishes to motivate women to have a healthy diet, and be physically~     active. It allows automatic transfer of blood glucose measures from the glucose meter to the~     smartphone. The women will answer questionnaires during pregnancy and be followed up three~     months postpartum.~   "
74733|NCT02588716|"~     To evaluate the effects of Terlipressin infusion on blood loss & transfusion requirements in~     cirrhotic patients undergoing major liver resections.~   "
74734|NCT02588703|"~     The current study evaluates the efficacy of Cognitive Behavioral Therapy (CBT) in DUI~     programs for individuals with a first-time offense. Investigators will utilize a two-group~     randomized design where individuals enrolled in a DUI program with a first-time conviction~     will be randomized to Cognitive Behavioral Therapy (CBT; n=150) or Usual Care (UC; n=150).~     Participants will be assessed at baseline, immediately post-treatment, and 6-months~     post-treatment. Recidivism data will also be collected using administrative data two years~     post-treatment.~   "
74735|NCT02588690|"~     Cardiovascular disease (CVD) is the leading cause of death world-wide in women. Despite~     current medical advances, heart disease is rising in relatively young women. Women access~     primary care differently than men, most utilizing their Obstetrics-gynecology clinic for~     primary care services. The recent implementation of the Affordable Care Act (ACA) aims to~     provide increased access to primary care services, however, women are still not appropriately~     risk stratified for CVD disease risk. Many women still are not aware that they are at risk~     for CVD. This is particularly true for the 15-44 year old female age group. Lack of proper~     risk stratification may be related to women not being properly identified or appropriately~     referred to preventive cardiovascular services for treatment of traditional risk factors such~     as diabetes, obesity, hypertension, and dyslipidemia. These traditional risk markers serve as~     examples of chronic diseases, which are not always recognized in the early stages and~     therefore not optimally managed. Furthermore, if women are not feeling ill, they are less~     likely to access their current primary care resources for preventive strategies.~     Investigators propose to risk stratify women in places where they usually congregate. In~     addition to convenience, current risk stratification is improved with the recent~     implementation of the ASCVD risk calculator. Investigators hypothesize that if women were~     properly risk stratified and referred to appropriate preventive cardiovascular risk clinics,~     more preventive strategies could be implemented, therefore reducing the amount of unnecessary~     premature disease in women. To achieve this ambitious goal, investigators propose a three~     step, demonstration project.~      The specific aims of this proposal is to:~        1. Provide women with CVD risk stratification in places where they locally convene on a~          daily basis.~        2. To evaluate the efficacy of a lay professional to adequately assess CVD risk.~        3. To evaluate if assessment of CVD risk reduces the amount of future CVD (unsure if this~          can be measured in this project).~      The specific aims:~        1. Demonstrate feasibility and acceptability of strategies utilizing ASCVD risk assessment.~        2. Improve ASCVD risk scores one year follow-up.~        3. Increase heart disease awareness through marketing materials in women in Los Angeles.~        4. Develop preliminary feasibility and efficacy data for a large clinical outcome trial.~   "
74736|NCT02588677|"~     The objective is to compare the efficacy and safety of masitinib in combination with riluzole~     in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS).~   "
74737|NCT02588664|"~     The purpose of this pragmatic study is to investigate whether implementation of a~     comprehensive post-acute stroke service model that integrates Early Supported Discharge (ESD)~     and Transitional Care Management (TCM) for stroke survivors discharged home improves~     functional outcomes post-stroke, reduces caregiver stress, and reduces readmission rates.~   "
74780|NCT02588105|"~     The purpose of this study is to determine whether AZD0156 is safe, what is the best dose to~     give, and how it is processed by the body when given alone or in combination with other~     agents. The study will also collect some initial information about how effective it is.~   "
74738|NCT02588651|"~     This study will include patients with mature T-cell lymphoma (MTCL) that has been treated~     with at least one type of chemotherapy, but is not responding or coming back after the~     previous treatment.~      This clinical trial uses a drug called Brentuximab Vedotin. The Food and Drug Administration~     (FDA) has approved Brentuximab Vedotin for sale in the United States for certain diseases.~     Brentuximab is still being studied in clinical trials like this one to learn more about what~     its side effects are and whether or not it is effective in the disease or condition being~     studied.~      Brentuximab Vedotin is a type of drug called an antibody drug conjugate (ADC). ADCs usually~     have 2 parts; a part that targets cancer cells (the antibody) and a cell killing part (the~     chemotherapy). Antibodies are proteins that are part of your immune system. They can stick to~     and attack specific targets on cells. The antibody part of Brentuximab Vedotin sticks to a~     target called CD30. CD30 is an important molecule on some cancer cells (including non Hodgkin~     lymphoma) and some normal cells of the immune system. The cell killing part of Brentuximab~     Vedotin is a chemotherapy called monomethyl auristatin E (MMAE). It can kill cells that the~     antibody part of Brentuximab Vedotin sticks to. Brentuximab Vedotin has also been shown to~     kill cancer cells with levels of CD30 that cannot be seen by traditional methods.~      This study is being done to test if the study drug has an effect on Mature T cell Lymphoma~     with such low levels of a target called CD30 and how your disease respond to the study drug.~   "
74739|NCT02588638|"~     In the study, NextGen SE are on-hand a cohort comprising each 50 pediatric and 50 adult~     patients, and in which there are an unclear movement disorder or an unclear cognitive~     disorder, examines the following questions :~      Primary:~        -  Number of diagnoses made by NGS~      Secondary:~        1. restriction of the quality of life by unclear disease~        2. Cost of not purposeful preliminary diagnostics ( beyond the minimal diagnostic data set~          )~        3. Impact of the diagnosis to therapy and follow-up examinations~        4. Time to diagnosis~   "
74740|NCT02588625|"~     This is a two part study.~      The purpose of Part A is to determine if BMS-986020 is effective in treatment of diffuse~     cutaneous systemic sclerosis using one dose of BMS-986020.~      The purpose of Part B is to determine if BMS-986020 is effective in treatment of diffuse~     cutaneous systemic sclerosis using two different doses of BMS-986020.~   "
74741|NCT02588612|"~     This study is intended for men and women at least 18 years of age who have advanced lung~     cancer which has grown or returned after being treated. In particular, it is a study for~     subjects who have a blood test positive for HLA-A*0201, HLA-A*205 and/or HLA-A*0206 protein~     and a tumor test positive for NY-ESO-1 expression (protein or gene). The study will take the~     subject's T cells, which are a natural type of immune cell in the blood, and send them to a~     laboratory to be modified. The changed T cells used in this study will be the subject's own T~     cells that have been genetically changed with the aim of attacking and destroying cancer~     cells.~      The manufacturing of T cells takes about 1 month to complete. The T cells will be given back~     to the subject through an intravenous infusion. The purpose of this study is to test the~     safety of genetically changed T cells and find out what effects, if any, they have in~     subjects with lung cancer.~      Subjects will be seen frequently by the Study Physician right after receiving their T cells~     back. Subjects will then be entered into a long-term follow up in order to monitor the~     subject. Subjects will be seen every 6 months by their Study Physician for the first 5 years~     after the T cell infusion. If the T cells are found in the blood at five years, then the~     subjects will continue to be seen once a year until the T cells are no longer found in the~     blood for a maximum of 15 years. If the T cells are no longer found in the blood at 5 years,~     then the subject will be contacted by the Study Physician for the next 10 years.~   "
74742|NCT02588599|"~     The purpose of this study is to determine whether low level laser therapy (LLLT) using the~     Erchonia LUNULA device is effective in increasing clear nail in toenails with onychomycosis.~   "
74743|NCT02588586|"~     This study evaluates the effects of four infusions of 3BNC117 in preventing or delaying~     rebound of viral load during a brief treatment interruption of standard ART, and its safety~     during a brief analytical interruption of antiretroviral therapy.~   "
74744|NCT02588573|"~     The objective of the study is to compare the overall subjective comfort profile over 8 hours~     of lens wear in two groups of habitual soft contact lens wearers (frequent replacement and~     daily disposable hydrogel lenses) when refitted into Clariti 1-Day.~   "
74745|NCT02588560|"~     In last few years, most researches about hepatic complication after chemotherapy focused on~     hepatitis B virus (HBV). With adequate prophylaxis and monitor, HBV-related hepatitis flares~     can be prevented. In contrast, cancer patients with hepatitis C virus (HCV) infection are~     traditionally considered as relative safe to receive chemotherapy. However, two large~     retrospective studies recently showed that severe hepatitis could develop in 14-27% lymphoma~     patients with chronic HCV infection, including 3-4% hepatic failure. The risk factors to~     predict severe hepatitis are pre-treatment elevated ALT level and liver cirrhosis. Due to the~     lack of prospective studies, the dynamic changes of serum HCV RNA levels and the association~     of hepatitis are still unclear.~      Some epidemiologic studies demonstrated an association between HCV infection and B-cell~     lymphoma. Diffuse large B-cell lymphoma (DLBCL) is the most common lymphoma and several~     reports showed higher prevalence of HCV infection among DLBCL patients than the controls. HCV~     infected DLBCL patients are reported to have distinct clinical characteristics, such as~     older, more with elevated LDH levels, and more with extra-nodal involvement. Regarding the~     impact of HCV infection on prognosis, the results are conflicting. Taiwan is an endemic area~     of HCV but there are limited reports addressing the clinical characteristics and prognosis in~     this unique population.~      Therefore, the investigators initiate a prospective, multi-center observational study to~     clarify the dynamic association between serum HCV RNA levels and hepatitis in HCV-infected~     lymphoma patients treated with chemotherapy.~   "
74746|NCT02588547|"~     This study compares the efficacy of two different doses of intravenous (IV) granisetron on~     the prevention of postspinal shivering during cesarean section, in comparison with placebo.~   "
74747|NCT02588534|"~     A single-center, open-label, randomized study with a screening period of up to 21 days.~     Following that, eligible men and women will receive 50 mg of etanercept subcutaneously in the~     thigh to compare injection by auto-injection device to manual injection (each injection~     separated by 28 days)~   "
74750|NCT02588495|"~     During surgery, there is a risk that food or liquid in the stomach might be forced back up~     the throat where it could enter the lungs (aspirate) and result in serious complications or~     even death. This is why people going for surgery are required not to eat before their~     surgery. However, in emergency situations it is often not possible to know whether a patient~     has recently eaten or not. Anesthesiologists have recently developed an ultrasound test to~     determine if there is content in a patient's stomach and how much. This test involves an~     ultrasound examination of the abdomen and taking some measurements on the ultrasound screen.~      The purpose of this study is to determine how accurate these measurements are. In other~     words, how good are we at detecting an empty stomach from one that has liquids, or solids in~     it. You are being asked to participate in this study because we require non-pregnant~     volunteers in order to answer the aforementioned study question.~   "
74751|NCT02588482|"~     The purpose of this study is to measure whether high-density electroencephalography can~     improve the detection of electrophysiological signs of awareness compared to conventional~     electroencephalography in post-anoxic comatose patients~   "
74752|NCT02588469|"~     The purpose of this study is to assess the effects of physical exercise, associated or not~     with venous compression of the leg, on obstructive sleep apnea (OSA) severity and upper~     airway resistance in obese teenagers. Half of the participants will undergo physical exercise~     and compression socks program, and the other half of subjects will undergo physical exercise~     program without compression socks.~   "
74753|NCT02588456|"~     This is a single center, single arm, open-label pilot study to determine the feasibility and~     safety of a single dose of autologous T cells expressing CD22 chimeric antigen receptors~     expressing tandem TCRζ and 4-1BB (TCRζ/4-1BB) co-stimulatory domains (referred to as CART22~     cells) administered in split fractions, in adult patients with relapsed or refractory B-cell~     acute lymphoblastic leukemia.~   "
74754|NCT02588443|"~     The main purpose of this study is to learn if adding the investigational drug RO7009789~     (anti-CD40) to nab-paclitaxel and gemcitabine both before surgery and after surgery is safe,~     feasible, and beneficial to patients with pancreatic cancer. This study also intends to look~     at blood and tissue samples to help doctors better understand the role of the immune system~     in fighting cancer.~   "
74755|NCT02588430|"~     This study is a non-invasive registry to monitor the safety and efficacy of patients using~     the CE-certified RETINA IMPLANT Alpha.~   "
74756|NCT02588417|"~     To evaluate the effectiveness of adding dexamethasone to intrathecal levobupivacaine in~     combined spinal epidural (CSE) analgesia during vaginal delivery.~   "
74757|NCT02588404|"~     The objective of this study is to evaluate the predictive value of TMPRSS2-ERG gene fusion in~     patients with prostate cancer treated with radiation and hormonal therapy.~   "
74758|NCT02588391|"~     The purpose of this study is to determine if different forms of child-friendly,~     computer-based puzzles and games (brain training) targeting executive function (EF) skills~     (i.e., thinking, problem-solving) result in improvements in EF in preschool children at risk~     for EF problems due to premature birth. The investigators hypothesize that children receiving~     active brain training will show greater improvements in EF and related skills immediately~     after treatment than children receiving passive brain training. The investigators are also~     interested in whether any improvements in EF and related skills occur or are maintained at 3~     and 6 months after completion of brain training.~   "
74759|NCT02588378|"~     This prospective, non-therapeutic study will compare the relative utility of multiple ocular~     imaging modalities in the detection of the cellular immune response in patients with AMD and~     related disorders.~   "
74760|NCT02588365|"~     The purpose of this study is to determine if different forms of child-friendly,~     computer-based puzzles and games (brain training) targeting executive function (EF) skills~     (i.e., thinking, problem-solving) result in improvements in EF in preschool children with or~     at-risk for Attention-Deficit/Hyperactivity Disorder (ADHD) and EF problems. The~     investigators hypothesize that children receiving active brain training will show greater~     improvements in EF and related skills immediately after treatment than children receiving~     passive brain training. The investigators are also interested in whether any improvements~     in EF and related skills occur or are maintained at 3 and 6 months after completion of brain~     training.~   "
74761|NCT02588352|"~     The current prospective cross-sectional pilot study is proposed to determine a set of~     characteristic factors associated with salt sensitivity in young adults by measuring blood~     pressure, serum aldosterone levels, urine analysis, arterial pulse wave velocity and central~     arterial pressure in response to short term increases in salt intake.~   "
74762|NCT02588339|"~     This study will test PANO in combination with tacrolimus/sirolimus (TAC/SIR) for acute GVHD~     prevention. The purpose of this study is to determine if Panobinostat (PANO) when used in~     combination with sirolimus and tacrolimus will help reduce the incidence of Graft-vs-host~     disease (GVHD).~   "
74763|NCT02588326|"~     Currently FDA does not accept pharmacokinetic studies to show bioequivalence of~     locally-acting nasal suspension formulations.~      However, bioequivalence is defined as the absence of significant differences in~     pharmacokinetics of therapeutically equivalent drug products compared to the matching~     originally invented drug formulation. These there-called generic drugs are then~     interchangeable. Drug companies have to show that their generic version has the same active~     ingredient, the same label, is intended to be used for the same conditions or diseases and~     works at the same rate in the body.~      The aim of the study is to determine if pharmacokinetics is sensitive to differences in the~     particle size distribution of two different nasal suspension formulations of mometasone~     furoate during charcoal block. The result from this study will aid the FDA in finding methods~     to ensure that generic products are the same as the trade name drugs.~   "
74764|NCT02588313|"~     Aim of the study is to investigate long-term effects of CarelessTM, a Mangifera indica fruit~     powder on microcirculation and endothelial function after supplementation of 4 weeks. Effects~     will be investigated with 100mg and 300mg CarelessTM and compared to placebo.~   "
74781|NCT02588092|"~     This study evaluates ADCT-301 in patients with Acute Myeloid Leukemia (AML) or Acute~     Lymphoblastic Leukemia (ALL). Patients will participate in a dose-escalation phase (Part 1)~     and receive ADCT-301 either weekly or once every 3 weeks.~      In Part 2 of the study, patients will receive a recommended dose of ADCT-301 as determined by~     a Dose Escalation Steering Committee.~   "
74765|NCT02588300|"~     This is a prospective, interventional cohort study of drug-induced sleep endoscopy (DISE).~     The goal is to evaluate the upper airway in a cohort of patients with obstructive sleep apnea~     hypopnea syndrome (OSAHS) diagnosed in a prior polysomnography.~      This study correlates the sedation level measured by entropy during DISE using propofol via a~     TCI pump with the local obstruction patterns of the upper airway according to the VOTE~     classification.~      As OSAHS is a widespread disease and the DISE procedure has become a common tool for~     diagnosis and evaluation of further treatment, a growing number of research articles deal~     with this topic. These articles are available through pubmed.~   "
74766|NCT02588287|"~     This study evaluates the effect of sofosbuvir/ledipasvir (SOF/LDV) treatment on the~     pharmacokinetics (PK) and renal safety of tenofovir. Subjects receiving tenofovir-based~     antiretroviral therapy with human immunodeficiency virus (HIV) protease inhibitors (HIV PI/r)~     and initiating SOF/LDV treatment for Hepatitis C virus (HCV) will be invited to participate.~     The study consists of three visits: a screening visit and two abbreviated 4-hour~     pharmacokinetic visits (one before initiating SOF/LDV and a second approximately 4 weeks~     after initiating SOF/LDV).~   "
74767|NCT02588274|"~     Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) affects many adult men worldwide.~     So far, available therapies offer little or no proven benefit to CP/CPPS. The investigators~     design and implement this study is to assess efficacy of acupuncture therapy performed in the~     CP/CPPS .~   "
74768|NCT02588261|"~     The purpose of the study is to evaluate the progression free survival (PFS), based on~     independent radiologic review (IRR), of ASP8273 compared to erlotinib or gefitinib in~     patients with locally advanced, metastatic or unresectable stage IIIB/IV adenocarcinoma~     non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) activating~     mutations.~      This study will also assess Overall survival (OS); Overall response rate (ORR) as assessed by~     IRR; PFS as assessed by the investigator; Disease control rate (DCR) as assessed by IRR;~     Duration of Response (DOR) by IRR; Safety of ASP8273; and Quality of Life (QOL) and~     patient-reported outcome (PRO) parameters.~   "
74769|NCT02588248|"~     The primary objective of this double-blinded, prospective, randomized placebo-controlled~     study is to evaluate for change in endoscopic adenoma detection rates (ADR) with the use of~     peppermint oil solution vs placebo application during colonoscopy. The investigators~     hypothesize that ADR will be increased with the use of the peppermint oil solution and thus~     further reduce the risk of colon cancer by means of colonoscopy.~   "
74770|NCT02588235|"~     After successful coronary angiography and OCT examination, patients with TCFAs in~     non-culprit, mild-to-moderate stenotic lesions will be enrolled. Then, they will be randomly~     assigned in a 1:1 ratio to receive either atorvastatin (20 mg/day) alone or atorvastatin (20~     mg/day）plus ezetimibe（10 mg/day）by envelope method. Angiographic and OCT follow-up will be~     scheduled for the target vessel after 12 months.~   "
74771|NCT02588222|"~     The purpose of this study is to establish reliable reference intervals for fecal S100A12 in~     healthy children.~   "
74772|NCT02588209|"~     This study will provide cognitive screenings for seniors age 50 and older. It will also~     investigate the benefits of two different cognitive training programs for seniors who have~     lower baseline performance on memory and/or gist reasoning tests.~   "
74773|NCT02588196|"~     The study aimed to evaluate the relationships between the gene polymorphisms of leukotriene~     A4 hydrolase(LTA4H) and Dexamethasone treatment for tuberculous meningitis in Chinese~     patients.~   "
74774|NCT02588183|"~     The COR advance study is a non-randomized prospective single center study to assess the~     results of an electrophysiologically guided approach for PV cryoablation using the Arctic~     Front Advance ST® catheter together with the Achieve® mapping catheter in 25 patients with~     drug-refractory paroxysmal AF.~      Methods Patient selection criteria will be the same that in the original COR study. All~     patients will be followed with a Reveal LINQ® cardiac monitor that will be implanted before~     ablation. The primary objective is the proportion of patients remaining free from atrial~     fibrillation recurrences without taking antiarrhythmic drugs 12 months after ablation.~     Secondary objectives are: AF-free survival without anti arrhythmic drugs 12 months after~     ablation, cumulative AF burden (number of AF episodes and percentage of time in AF) 12 months~     after ablation, percentage of the pulmonary veins with bidirectional block at the end of the~     procedure, and ablation time (from the onset of the first energy delivery to the end of the~     last energy delivery), procedure time (from femoral puncture to catheter removal), and~     fluoroscopy time.~      Final results will be known 24 months after the first enrollment. Statistical analysis~     Continuous variables that are distributed normally according to the Shapiro-Wilk test will be~     presented as the mean [standard deviation], and the values will be compared with the t test.~     Continuous variables that do not follow a normal distribution will be presented as the median~     [25th to 75th percentile] and will be compared with the Mann-Whitney U test. Categorical~     variables between two groups with expected values <5 will be compared with the Fisher exact~     test. Otherwise, categorical variables will be compared with the chi-squared test. The~     AF-free survival functions will be represented as Kaplan-Meier curves. Data analyses will be~     done with JMP® (version 9.0.1, SAS Institute Inc., Cary, NC, USA) and Stata® (version 11.0,~     StataCorp LP; College Station, TX, USA).~   "
74775|NCT02588170|"~     A randomized, double-blind, placebo controlled, multi-center Phase III study to assess the~     efficacy of Sulfatinib 300 mg once a day in treating advanced extrapancreatic neuroendocrine~     tumors.~   "
74776|NCT02588157|"~     Non- Fasted patients need rapid sequence intubation. The investigators aimed to compare the~     intubation times of Macintosh , and McGrath X-Blade or Glidescope in these Ascenario.~   "
74777|NCT02588144|"~     54 patients with idiopathic Parkinson's disease and freezing of gait resistant to subthalamic~     nucleus stimulation and dopaminergic medication will be included into this multicentre~     randomised controlled double-blinded parallel group clinical trial. The treatment consists of~     two different stimulation settings using (i) conventional stimulation of the subthalamic~     nucleus [standard STN] as active comparator and (ii) combined stimulation of active electrode~     contacts located in both the subthalamic nucleus and substantia nigra pars reticulata~     [STN+SNr].~   "
74778|NCT02588131|"~     This phase 2, open-label, single arm study aims to evaluate the efficacy of tremelimumab in~     combination with the anti-PD-L1 MEDI4736 in patients with unresectable malignant mesothelioma~     subjects~   "
74779|NCT02588118|"~     In recent years it has become clear that gender differences exist both in the~     pharmacokinetics and the pharmacodynamics of drugs related to the practice of anesthesia.~     Differences in pharmacokinetics are more straightforward to study than differences in~     clinical effects. However, isolated pharmacokinetic data are of less value if they are not~     accompanied by measurements of clinical effects. Males are more sensitive than females to~     propofol. It may therefore be necessary to decrease the propofol dose by 30-40% in males.~     Females have 20-30% greater sensitivity to the muscle relaxant effects.~   "
74783|NCT02588066|"~     To investigate, whether a prophylactic wrapping of the gastroduodenal artery stump with the~     ligamentum teres or falciform hepatic (embryological structures, covered with peritoneum that~     do not have relevant meaning for adults) can reduce the incidence of arrosion bleeding during~     surgery.~      Thus a surgical technique is evaluated prospectively.~   "
74784|NCT02588053|"~     Primary Aims: To determine how effective long term Natalizumab (NTZ) therapy is in slowing~     the progression of whole brain atrophy. Whole brain atrophy rates will be measured through~     magnetic resonance imaging (MRI) scans and compared between patients with Multiple Sclerosis~     (MS) who have been using NTZ for at least 2 years versus age and gender-matched healthy~     controls. The primary outcome will be whole brain atrophy rate measured as the percent change~     in brain volume (PBVC) over a two-year period.~      Primary hypothesis:~      The investigators hypothesize that long term (>2 years) NTZ therapy will slow the rate of~     whole brain atrophy in patients with Multiple Sclerosis (MS) (as measured by percent change~     in brain volume), reaching a whole brain atrophy rate similar to that of non-MS controls (a~     true disease activity free state).~   "
74785|NCT02588040|"~     The objective of the study is to further characterize the performance of L-PRP prepared using~     the Biomet Recover Kit in the treatment of chronic LE. The study will explore the potential~     impact of patient demographics and baseline characteristics on treatment outcome. Furthermore~     it will track and document treatment effects, time course, and untoward effects following~     treatment of chronic LE with L-PRP from the Recover device. In addition, the utilization of~     healthcare resources and associated costs will be investigated in treated patients.~   "
74786|NCT02588027|"~     This will be a randomized controlled trial to determine if postoperative ibuprofen after~     arthroscopic rotator cuff repair impacts postoperative opiate medication use, Visual Analog~     Scale (VAS) pain scores, shoulder range of motion (ROM), and repair integrity.~   "
74787|NCT02588014|"~     The purpose of this project is to examine potential mechanisms that may underlie early visual~     and auditory perception as well as visual and auditory affect perception deficits in~     schizophrenia and the possible connection between these processes. Given that affect~     perception largely involves visual and/or auditory information processing and likely relies~     on intact basic visual and/or auditory perceptual mechanisms, the investigators will examine~     affect perception deficits within the framework of the more basic visual and auditory~     processes. Specifically, the investigators will examine magnetophysiological correlates of~     vocal and visual affect discrimination, non-affective face discrimination and voice~     discrimination, and simple visual and auditory stimulus discrimination, using~     Magnetoencephalography (MEG), to identify neural mechanisms underlying perceptual deficits,~     as well as their contribution to affect perception deficits in schizophrenia.~   "
74788|NCT02588001|"~     The purpose of this study is to investigate the efficacy and safety of enzalutamide in~     patients with non-metastatic castration resistant prostate cancer. The total duration of the~     study will be 5 years. All patients will receive enzalutamide 160 mg (four 40 mg capsules)~     orally once daily. The treatment will be started at Visit 0 within one week after enrollment.~     Visit 1 is at 2 weeks after the treatment started; clinical assessments are conducted on~     adverse events and the Japanese version of the Functional Assessment of Cancer~     Therapy-Prostate (FACT-P) scales. Patients who are considered to be adequate by the~     investigator can continue the treatment with 12-week cycle visit (counted from initial dose)~     until patients meet withdrawal criteria. Patients will be followed up at 2 and 3 years after~     enrollment and at 3 years after the last participant enrollment. The end of the study is~     defined as follow-up assessment date at 3 years after the last participant enrollment.~     Patients will primarily be assessed by prostate-specific antigen (PSA) progression-free~     survival (PFS).~   "
74789|NCT02587988|"~     Trial to Evaluate the Efficacy and Safety of HCP1302~   "
74790|NCT02587975|"~     This study is designed to measure the effect of evogliptin on bone metabolism in healthy~     volunteers.~   "
74791|NCT02587962|"~     An ascending dose study in patients with solid tumors to evaluate the safety, tolerability,~     pharmacodynamics and efficacy of birinapant when given in combination with pembrolizumab. A~     dose expansion phase of 4 cohorts will also be included.~   "
74792|NCT02587949|"~     In patients admitted to hospital with acute cerebrovascular stroke, we want to study the~     relationship between hair cortisol levels and biomarkers of inflammation and the clinical and~     radiological severity of the stroke and the degree of neurological disability being tested in~     three months and one year after.~   "
74793|NCT02587936|"~     ICD-Pieces (Parkland Intelligent e-Coordination and Evaluation System) trial is a National~     Institutes of Health (NIH) Healthcare Systems(HCS) Collaboratory demonstration project to~     improve management of patients with a triad of Chronic Kidney Disease, hypertension and~     diabetes with Pieces in four HCS including Parkland, Texas Health Resources (THR), ProHealth~     Physicians Incorporation and North Texas VA. Pieces is a decision support technology platform~     created by Parkland Center for Clinical Innovation(PCCI).~      The primary objective is to test the hypothesis that a collaborative model of primary care~     and subspecialty care intervention enhanced by Pieces and practice facilitators compared to~     standard clinical practice will reduce all-cause hospitalizations in patients with coexisting~     chronic kidney disease, diabetes and hypertension.~      Secondary objectives are: a)Test if implementation of the collaborative model will reduce~     30-day readmissions, emergency room visits, cardiovascular events or deaths and~     disease-specific hospitalizations; b) Develop and validate risk predictive models for~     disease-specific hospitalizations, all-cause hospitalizations, 30-day readmissions, emergency~     room visits, cardiovascular events and deaths for patients with chronic kidney disease,~     diabetes and hypertension. c) Collect demographic and clinical data to assist phenotyping~     patients with chronic kidney disease, diabetes and hypertension. d) Obtain safety data~     including Acute Kidney Injury, progression of chronic kidney disease, electrolyte~     disturbances and medication errors, and drug toxicity; e) Collect resource utilization~     information including hospitalizations, emergency room visits, outpatient visits, and~     diagnostic or therapeutic procedures completed.~      Candidate patients in selected clinics will be enrolled over a period of 2 years and followed~     for 12 months. Pieces will ascertain both primary and secondary outcomes from the Electronic~     Health Record supported with data from the Dallas Fort Worth Hospital Council (DFWHC),~     Accountable Care Organization (ACO) reports and VA database, and deaths from Social Security~     Index (SSI) data.~   "
74794|NCT02587923|"~     Background: Accurate diagnosis of small gastric subepithelial tumors (SETs) is essential in~     order to assess their malignant potential. Endoscopic unroofing by conventional snare or~     needle knife has been reported to yield sufficient tissue samples for histological evaluation~     including immunohistochemical staining.~      Aims: The investigators aim to evaluate endoscopic unroofing in patients with small gastric~     SETs regarding its safety and diagnostic accuracy as well as a potential therapeutic effect~     of this technique over time.~      Methods: In the context of a retrospective analysis, the investigators will identify patients~     who underwent endoscopic unroofing of small SETs of the stomach at the Medical University of~     Vienna. Demographic data, indication for intervention, safety of the procedure and follow‐up~     will be assessed.~   "
74795|NCT02587910|"~     Melanole, a Nigella sativa (Black Seed) extract , is studied for the treatment of GERD.~     Participants, who meet the inclusion criteria, will be divided into two arms.~      Arm 1: Subjects who meet criteria for GERD will undergo 24 hour pH monitoring.~      Arm 2: Subjects who meet criteria for GERD and who undergo only symptomatic monitoring of~     GERD on treatment.~      All participants will be evaluated before and after the administration of the study product.~   "
74796|NCT02587897|"~     Carpal tunnel syndrome is the most expensive upper extremity work-related musculoskeletal~     disorder, impacting 10 million people annually and costing employers up to $113,695 per~     incident. There is currently no established method to detect this disorder prior to the onset~     of symptoms and nerve damage. Preliminary research suggests that sonography—a relatively~     inexpensive, widely available, increasingly portable technology—can provide a non-invasive~     and pain-free method of early detection that could reduce incidence, improve targeted~     interventions and ultimately reduce costs. The primary aims of this study are to establish~     predictive validity of a novel method for early detection using sonographic imaging and to~     identify task components of intensive functional hand activity associated with morphologic~     changes.~   "
74797|NCT02587884|"~     The aim of this study is to explore the effect of Transarterial Chemoembolization (TACE) on~     the prognosis of patients with microvascular invasion presence(MVI) and overexpression of~     Aspartate-β-hydroxylase(ASPH).~   "
74798|NCT02587871|"~     This phase II trial studies how well donor cellular therapy after cytarabine works in~     treating patients with intermediate-risk acute myeloid leukemia with a decrease in or~     disappearance of signs and symptoms of cancer. Donor cellular therapy is a short-term~     transfusion of cells from a family member who is incompletely matched. The use of these~     partially matched white blood cells may help improve response to standard chemotherapy~     (cytarabine) and reduce some of the risks of infection, without a permanent transplant. Drugs~     used in chemotherapy, such as cytarabine, work in different ways to stop the growth of cancer~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Giving donor cellular therapy after cytarabine may kill more cancer cells.~   "
74799|NCT02587858|"~     The purpose of this study is to learn more about Neurodegeneration with Brain Iron~     Accumulation (NBIA) Disorders. Data is being collected on three types of NBIA disorders:~      Pantothenate Kinase-Associated Neurodegeneration (PKAN), PLA2G6-associated Neurodegeneration~     (PLAN) and Beta-propeller Protein-associated Neurodegeneration (BPAN). The study will be (1)~     collecting information about how symptoms and findings in NBIA change over time and (2)~     identifying measures of NBIA that can be used in future clinical trials. Participants will~     follow links to a secure website every 6 months for a period of 5 years to electronically~     complete a set of rating scales as related to their NBIA disorder.~   "
74800|NCT02587845|"~     Studies have shown that tranexamic acid reduces blood loss and transfusion need in patients~     undergoing total hip arthroplasty. However, no to date, no study has been large enough to~     determine definitively whether the drug is safe and effective. The present study was designed~     to verify noninferior efficacy and safety of topical intra-articular TXA compared with~     intravenous TXA in primary THA.~   "
74801|NCT02587832|"~     To compare the primary outcome, failure of extubation defined by the need for re-intubation~     and mechanical ventilation within 5 days of initial extubation and secondary outcomes,~     morbidities and mortality after using of heated humidity high flow nasal cannula (HHHFNC) and~     Nasal Continuous Positive Airway Pressure (NCPAP) in the immediate post-extubation period for~     preterm infants between 24 and 28 weeks gestation with respiratory distress syndrome.~   "
74802|NCT02587819|"~     This is a Phase 1, open-label, single-arm, multicenter study to assess the safety and~     tolerability of BSCT (anti-nf-P2X7) 10% Ointment in subjects with BCC.~   "
74803|NCT02587806|"~     STUDY OBJECTIVES:~      Primary Objective: Assessment of treatment safety based on incidence of any treatment~     emergent/treatment associated adverse events prior to discharge and at 1, 3, 6 and 12 months~     post treatment.~      Secondary objective: Assessment of efficacy at baseline, prior to discharge, 1 month, 3~     months, 6 months and 12 months after treatment based on the following: EDSS and 29-item~     Multiple Sclerosis Impact Scale (MSIS-29), MS Functional Composite (MSFC) consisting of (1)~     Timed 25-Foot Walk, (2) 9 Hole Peg Test, and (3) Paced Auditory Serial Addition Test and~     gadolinium-enhanced magnetic resonance imaging (MRI).~   "
74804|NCT02587793|"~     The aim of this project is to investigate whether the proliferative speeds of cultured cells~     using our method can be integrated into Barcelona Clinic Liver Cancer (BCLC) staging~     classification for the possibility of personalized treatment and prediction the outcomes in~     hepatocellular carcinoma (HCC) patients.~   "
74805|NCT02587780|"~     This observational study is designed to examine the glycaemic responses (of sedentary, active~     and very active healthy individuals) to a 50gram dose of glucose.~   "
74806|NCT02587767|"~     The purpose of this study is to determine whether micropulse laser (MPL) is different to~     half-dose photodynamic therapy on acute central serous chorioretinopathy.~   "
74807|NCT02587754|"~     This study evaluates the efficacy of acupuncture in the treatment of fatigue in participants~     with Parkinson's Disease. Half of participants will receive real acupuncture while the half~     will receive placebo acupuncture.~   "
74808|NCT02587741|"~     Diabetic retinopathy (DR) is an important cause of blindness.~   "
74809|NCT02587728|"~     Carpal tunnel is an early manifestation of amyloidosis in a significant minority of patients.~     This specimen collection protocol will allow the investigators to screen patients with carpal~     tunnel syndrome for amyloidosis.~   "
74810|NCT02587715|"~     STUDY OBJECTIVES:~      Primary Objective: Assessment of treatment safety based on incidence of any treatment~     emergent/treatment associated adverse events prior to discharge and at 1, 3, 6 and 12 months~     post treatment.~      Secondary objective: Assessment of efficacy at baseline, prior to discharge, 1 month, 3~     months, 6 months and 12 months after treatment based on the following: EDSS and 29-item~     Multiple Sclerosis Impact Scale (MSIS-29), MS Functional Composite (MSFC) consisting of (1)~     Timed 25-Foot Walk, (2) 9 Hole Peg Test, and (3) Paced Auditory Serial Addition Test and~     gadolinium-enhanced magnetic resonance imaging (MRI)~   "
74811|NCT02587702|"~     The purpose of this study is to determine whether different content of β-palmitate will cause~     significant differences on Fatty Acids and Mineral Metabolism in Infants~   "
74813|NCT02587676|"~     Thirty complete maxillary denture wearers were recruited after obtaining informed consent.~     One investigator measured the Shore D hardness of the commercially available RDLs using a~     Vesmeter®. The salivary flow rates and pH values and the occlusal force were measured for all~     patients before initiation of the study.~      T-tests and Pearson's correlation coefficients were used for statistical analyses.~      A p-value of <0.05 was considered statistically significant.~   "
74814|NCT02587663|"~     This clinical trial studies mammography and targeted ultrasound with or without whole-breast~     ultrasound or contrast-enhanced magnetic resonance imaging (MRI) in finding out the extent of~     disease before surgery in patients with newly diagnosed breast cancer. New diagnostic imaging~     procedures, such as whole-breast ultrasound or contrast-enhanced MRI, may help find out how~     far breast cancer has spread. It is not yet known whether mammography and targeted ultrasound~     are more effective with or without whole-breast ultrasound or contrast-enhanced MRI in~     finding out how far breast cancer has spread.~   "
74815|NCT02587650|"~     This phase II trial studies how well capmatinib, ceritinib, regorafenib, or entrectinib work~     in treating patients with BRAF/NRAS wild-type stage III-IV melanoma. Capmatinib, ceritinib,~     regorafenib, or entrectinib may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth.~   "
74816|NCT02587637|"~     The purpose of this prospective post market observational pilot study is to evaluate the~     effect of DRG stimulation in the management of chronic discogenic pain in subjects who are~     refractory to other available treatments. Selected subjects will not be suitable candidates~     for lumbar spinal surgery and will meet the standard selection process for DRG stimulation as~     routinely utilised in the study centre. Results from this pilot study will inform current~     clinical practice and future comparative studies in this specific population.~   "
74817|NCT02587624|"~     Prospective observational single center trial, evaluating the safety, radiation exposure and~     efficacy of remote magnetic catheter ablation for atrial fibrillation in daily routine.~   "
74818|NCT02587611|"~     The purpose of this study is to compare the effect of either elemental liquid diet or~     standard semi-solid diet on gastric emptying in both healthy subjects and bedridden patients~     receiving gastrostomy feeding.~   "
74819|NCT02587598|"~     This is an open-label, dose-escalation study of the proviral integration site of Moloney~     murine leukemia virus (PIM) kinase inhibitor INCB053914 in subjects with advanced~     malignancies. The study will be conducted in 4 parts. Part 1 (monotherapy dose escalation)~     will evaluate safety and determine the maximum tolerated dose of INCB053914 monotherapy and~     the recommended phase 2 dose(s) (a tolerated pharmacologically active dose that will be taken~     forward into the remaining parts of the study). Part 2 (monotherapy dose expansion) will~     further evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of~     the recommended Phase 2 dose(s). Part 3 (combination dose finding) will evaluate safety of~     INCB053914 in combination with select standard of care (SOC) agents and will identify the~     optimal INCB053914 dose in combination with conventional SOC regimens to take forward into~     Part 4. Part 4 (combination dose expansion) will further evaluate the safety, efficacy and~     pharmacokinetics of the recommended Phase 2 dose combination(s).~   "
74820|NCT02587585|"~     The amount of activity completed by individuals within rehabilitation programs, even when~     units are well staffed, is often far below that required for optimal stroke rehabilitation,~     and is not individually adapted on a day-to-day basis. Daily feedback on their activity~     levels may motivate stroke survivors to engage in greater skills practice and thus outcome~     after stroke. To date only a few trials suggests that augmented feedback may be effective.~     There is a need for a large pragmatic trial to explore the impact of augmented activity~     feedback on top of their standard care. The purpose of this study is to determine the effect~     of augmented activity feedback by smart watches to support in-patient stroke rehabilitation.~   "
74821|NCT02587572|"~     This is a phase 2b, randomized, placebo-controlled clinical trial designed to evaluate the~     safety and efficacy of Longeveron Mesenchymal Stem Cells (LMSCs) in subjects with metabolic~     syndrome and to assess the effects of LMSCs on endothelial function using several different~     doses.~   "
74822|NCT02587559|"~     Approximately 60 subjects from a sample of convenience diagnosed with shoulder arthritis will~     be randomized into a two groups. The control group will receive usual medical advice and the~     experimental group will be referred to physical therapy for eight visits over 4-week period~     of time. At one month, two months, and one year the pain, function, and patient satisfaction~     will be compared between the two groups.~   "
74823|NCT02587546|"~     The purpose of the study is to compare results of the treatment of tumorous and non-tumorous~     laryngotracheal stenosis using thulium contact laser versus carbon dioxide laser used in the~     past.~   "
74824|NCT02587533|"~     Peripheral chemoreceptors and baroreceptors are located in close proximity in the carotid~     artery wall at the level of the carotid bifurcation. Baroreceptor stimulation lowers~     sympathetic activity and blood pressure. In contrast, chemoreceptor stimulation raises~     sympathetic activity and blood pressure. Thus, beneficial effects of electrical carotid sinus~     stimulation on blood pressure could be diminished by chemoreceptor overactivity and/or~     concomitant chemoreceptor activation through the device. Therefore, our study will assess~     baroreflex/chemoreflex interactions in patients with resistant hypertension equipped with~     carotid sinus stimulators. The study will inform us of potential additional anti-hypertensive~     benefits of simultaneous chemoreceptor denervation during electrode placement. Furthermore,~     the results may provide information about suitable electrode design to spare co-activation of~     peripheral chemoreceptors. Taken together, the study will help develop strategies for~     improving responder rate and efficacy of carotid sinus stimulators in patients with resistant~     hypertension.~   "
74825|NCT02587520|"~     This is a dose and formulation ranging study to assess the safety and immunogenicity of~     SP0173 in healthy adolescents, adults, and older adults in the US.~      Primary Objective~        -  To describe the safety profile of each SP0173 investigational formulation.~      Observational Objective:~        -  To describe the immunogenicity of each SP0173 investigational formulation.~   "
74866|NCT02586974|"~     The aim of this study is to assess if the conditioning of the insufflation carbon dioxide~     (CO2) allows for an additional benefit in terms of prevention of the heat loss, when compared~     with the usual prevention with a forced warm air blanket alone, in the setting of~     robot-assisted radical prostatectomy (RARP).~   "
74826|NCT02587507|"~     A high-fat, high-carbohydrate meal (HFHC) induces an increase in inflammation in~     peripheral-blood mononuclear cells in healthy subjects. A few studies have shown that orange~     juice, when consumed together with the high-fat meal, is able to revert the increase in~     inflammatory markers. The present study will assess the effect of a single HFHC meal taken~     with water, orange juice or an isocaloric glucose drink on protein expression in peripheral~     blood mononuclear cells of healthy individuals. Twelve healthy, normal weight individuals~     consumed a HFHC meal with water, water with glucose or orange juice in a cross-over design~     with at least one week interval between the meals. Blood samples were collected before, 1, 3~     and 5h after the meals.~   "
74827|NCT02587494|"~     This is a pilot study that will lead to a large randomized control trial (RCT), to assess~     whether early versus late or no cardiac catheterization is associated with improved outcomes~     in out-of-hospital cardiac arrest (OHCA) patients.~   "
74828|NCT02587481|"~     In this open, monocentric, observational study acute coronary syndrom (ACS) patients will be~     characterized by pneumological examination concerning a concomitant chronic obstructive~     pulmonary disease (COPD). Often COPD coexists with ACS; therefore ACS patients benefit either~     from prevention or potential therapy of chronic hypoxia.~   "
74829|NCT02587468|"~     GOAL To identify absorption kinetics and bioavailability of phenolic compounds and specific~     vitamins from encapsulated Juice Plus+® powder~      ENDPOINTS~        -  Absorption kinetics of phenolic compounds in plasma~        -  Bioavailability of vitamins C, E, and carotenoids into plasma~      Subjects: 20 healthy subjects from Graz region, meeting all inclusion criterions (see~     underneath).~   "
74830|NCT02587455|"~     Lung cancer is the second most common cancer in the UK with around 43,500 new patients~     diagnosed each year. About 69% of patients are diagnosed with advanced stage disease and at~     present these patients would be expected to survive for less than 12 months. These statistics~     therefore show the need for the development of new effective drugs in the treatment of~     advanced Lung cancer.~      Recent trial results have shown the efficacy of immunotherapy in treating several types of~     tumours including lung cancer. These tumours are known to express a high level of a~     glycoprotein called PDL1 which is a component of the PD1 pathway. In cancer the PD1 pathway~     can be hijacked by tumours leading to the immune system being suppressed. The aim of the new~     drug Pembrolizumab is to restart the PD1 pathway and use the immune system to help fight the~     cancer cells. Radiotherapy has also been shown to cause cancer to increase production of the~     proteins that can block the immune system. Therefore it has been proposed that combine of new~     immunotherapy agent such as pembrolizumab and radiotherapy in the treatment of lung cancer~     will allow more cancer cells to be killed through the immune system.~      The purpose of this study is to see if pembrolizumab can safety be combined with standard~     palliative radiotherapy in patients with lung cancer. In addition once the patients have~     completed their course of radiotherapy they will remain on pembrolizumab alone and the study~     will look at how well this treatment regimen can control the growth of the cancer.~   "
74831|NCT02587442|"~     This is a Phase 1, non-randomized, sequential-cohort, dose escalation, open-label study~     designed to evaluate the safety and tolerability of RadProtect® in healthy volunteers. This~     study is to be conducted at two clinical centers and in conformity with Good Clinical~     Practice (GCP).~   "
74832|NCT02587429|"~     The aim of this study is to investigate, whether a patient education with focus on pain~     coping is able to improve physical function and experienced pain level in patients with high~     levels of pain catastrophizing before Total Knee Arthroplasty. Resent studies indicates that~     these patients do not achieve a satisfactory pain relief and physical function after TKA.~     Furthermore, the aim is to determine if there is a difference in physical activity and muscle~     mass among patients with high levels of pain catastrophizing compared to patients with low~     levels of pain catastrophizing.~   "
74833|NCT02587416|"~     The purpose of this study is to determine the effect of gemcabene on the pharmacokinetics of~     atorvastatin 80 mg~   "
74834|NCT02587403|"~     The objective of this study is to compare the effectiveness of Fortiva Porcine Dermis versus~     Strattice Reconstructive Tissue Matrix for the underlay reinforcement of complex ventral~     hernia repair and assess post-operative complication rates, long term hernia recurrence~     rates.~   "
74835|NCT02587390|"~     The purpose of this study is to determine the effect of gemcabene on the pharmacokinetics of~     simvastatin 80 mg.~   "
74836|NCT02587377|"~     The availability of sensitive and specific fungal biomarkers could be a precious help to~     improve the management of patients suffering from fungal diseases, not only by allowing~     preemptive treatment, but also by offering objective elements to assess patient therapeutic~     response and prognosis.~      The use of such biomarkers could also contribute to accurately evaluate novel antifungal~     drugs effectiveness and to serve as a valuable tool to guide decisions regarding ineffective~     treatments and dose selection in product development. Using two or three tests may increase~     the sensitivity to detect IFI.~      The results of the serum assays will be correlated to the definition of 'proven' fungal~     infection as defined by the EORTC/MSG criteria published in 2008. Based upon results from~     adults' studies, the investigators estimate that galactomannan antigen or 1, 3 β-D glucan~     could reasonably have a 90% sensitivity (with a 95% CI between 73% and 98%) under the current~     design. As concern the aspergillus fumigatus PCR, sensitivity and specificity could be~     estimated between 63% to 100% and 87% to 96.7%, respectively.~   "
74837|NCT02587364|"~     The purpose of this study is to evaluate the multiple‐dose pharmacokinetic characteristics~     and pharmacologic activity of gemcabene.~   "
74838|NCT02587351|"~     This is a multicenter, prospective, randomized, double-blind, placebo-controlled trial that~     will enroll 1028 patients with at least moderately severe COPD over a three year period and~     follow them at regular intervals for one year. The primary endpoint is time to first acute~     exacerbation. Secondary endpoints include rates and severity of COPD exacerbations,~     cardiovascular events, all-cause mortality, lung function, dyspnea, quality of life and~     metoprolol-related side effects.~   "
74839|NCT02587338|"~     This study investigates the beneficial effects of prefrontal brain stimulation (with~     transcranial direct current stimulation [tDCS]) during working memory training in seniors~     with subjective memory impairments.The placebo-controlled double blinded study includes 50~     elderly probants which were randomized into verum or sham tDCS.~   "
74841|NCT02587312|"~     The purpose of this study is to determine how reducing the level of nicotine in cigarettes~     may affect adolescent smoking behavior. In this study, the researchers will randomize~     adolescent (age 15-19) daily smokers to either receive VLNC cigarettes or normal-nicotine~     content (NNC) study cigarettes for three weeks following a one-week usual-brand baseline~     period. Participants will be instructed to smoke only those cigarettes. The researchers will~     conduct daily assessments of total cigarette use (both study cigarette and non-compliant use~     of usual brand cigarettes), craving, and withdrawal, weekly assessments of breath carbon~     monoxide (CO) levels, cigarette acceptability, risk perceptions of VLNC and NNC cigarettes~     and demand for usual-brand cigarettes, and pre- vs. post-use measures of nicotine and~     toxicant exposure. Overall, the project will help determine how VLNC cigarettes may affect~     real-world smoking behavior in adolescents, and illuminate the potential mechanisms through~     which these products may effect such changes. Such knowledge will contribute to the science~     base that may inform future policy decisions.~   "
74842|NCT02587286|"~     The purpose of this trial is to explore the impact of the Gather Health diabetes management~     platform diabetics' health behaviors and health outcomes and how providers and diabetics~     interact with the Gather Health platform.~   "
74843|NCT02587273|"~     This study is part of a project intended to develop guidelines to optimise the dosing of~     fentanyl in intensive care patients.~      This study will focus on determining:~        -  Whether the pharmacokinetics of fentanyl change during the ICU stay.~        -  To what extent / the degree of change in fentanyl pharmacokinetics in ICU patients.~        -  Which factors (e.g. physiological variables) that cause such a change.~        -  Based on simulations, determine context-sensitive half-times of fentanyl in ICU~          patients.~   "
74844|NCT02587260|"~     The purpose of this randomized, cross-over study, is to ascertain if ticagrelor, but not~     prasugrel or clopidogrel, is associated to an improved endothelial function as assessed with~     peripheral arterial tonometry and markers of endothelial function measurement in post-ACS~     patients.~   "
74845|NCT02587247|"~     Evaluation of the sensitivity of the immuno-PET PET / CT pretargeted with the bispecific~     anti-CEA x anti-HSG TF2 antibody and IMP-288 peptide labeled with Gallium-68 for imaging~     potential candidate patients for surgery of local resection of one or more metastases at~     diagnosis or during relapse CCR expressing CEA.~   "
74846|NCT02587234|"~     The investigators proposed to evaluate the effectiveness of sustained peripheral nerve~     stimulation (PNS) to enhance the therapeutic effects of a modified form CIT (mCIT).~   "
74847|NCT02587221|"~     A Phase III, Randomized, Observer-Blind, Controlled, Multicenter Clinical Study to Evaluate~     the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine~     Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age.~   "
74848|NCT02587208|"~     Outcome of circumcision with Plastibell or conventional dissection techniques in infants and~     children: A prospective randomized controlled trial~      Aim: to evaluate and compare postoperative and esthetic outcomes after Plastibell and~     conventional dissection circumcision~      Methods:~      Randomized Controlled Trial Inclusion criteria: patients younger than 13 years including~     neonates who required circumcision for various indications.~      Exclusion criteria: - patients with bleeding or clotting disorders~        -  Those whose parents insisted on a particular type of surgery~        -  Children with lateral- lateral diameter of the glans over which a Plastibell device~          could not be placed Primary endpoint: parental concerns and satisfaction (questionnaire)~          Secondary endpoints: composite morbidity, operative time, postoperative pain (analgesic~          requirements)~        -  Early postoperative problems: infection, bleeding, swelling, dysuria, pain (incidence,~          mean duration, emergency care if necessary, parental concerns about them (on a~          Likert-type 5-point scale [ not at all, a little, rather, very, very much])~        -  Irregular scar, jumbling of tissues at the site of frenulum (assessed by physician)~        -  Postoperative adhesions (assessed by physician)~        -  Postoperative pain and analgesic requirements (paracetamol 15 mg/kg PO Q6 hrs for 48 hrs~          then PRN) number of doses and days required for analgesia as judged by parents, VAS ( >-~          6 SCORE ), Kaplan-Meier analysis (time to event)~        -  Parental satisfaction ( overall esthetic outcome [ very much satisfied, very satisfied,~          rather, a little satisfied, not at all satisfied])~        -  Parental satisfaction ( skin removal): excess skin removal, insufficient skin removal [~          not at all, a little, rather, very, very much]~        -  Time for bell separation (mean +-SD), Kaplan-Meier analysis for different age groups~   "
74849|NCT02587195|"~     National, multicenter study:~      The study consists of 3 periods:~        1. A baseline visit to confirm that patient is still in CIS status. All patients will be~          clinically evaluated for CDMS and an MRI (less than 2 months) will be analyzed to~          exclude MS patients according to 2010 Mc Donald's criteria.~        2. Treatment period with timed evaluations~        3. Post-treatment period: 4 weeks, with 2 visits following study drug discontinuation and~          accelerated elimination procedure. All patients who discontinue the study drug and~          according to investgator's decision, will perform the accelerated elimination procedure~          and the post- accelerated elimination visits (at 2 and 4 weeks after the end of~          treatment (EOT).~   "
74850|NCT02587182|"~     The objective of the present study was to assess the effectiveness of deep dry needling in~     the masseter and temporalis MTrPs on pain, pressure pain threshold (PPT), range of motion and~     disability in patients with sleep bruxism and myofascial temporomandibular disorders.~   "
74851|NCT02587169|"~     Phase I/II multicenter and prospective trial of nilotinib and adriamycin as neoadjuvant~     treatment in liposarcomas and leiomyosarcomas of retroperitoneum.~      The main objective of this study is to improve relapse-free survival (RFS)and overall~     survival (OS) decreasing from 50% to 30% the relapse percentage at 5 years in patients with~     resected sarcoma of retroperitoneum.~      Secondary objectives include the analysis of antitumoral activity through response rate~     (RECIST and tissular changes), the assessment of positive correlation between biomarkers and~     clinical results, the study of long term overall survival, and the analysis of the safety~     profile of the nilotinib-adriamycin combination.~      The trial hypothesis is that the nilotinib-adriamycin combination is synergistic and~     therefore better response results are expected (from 20% as P0 to 40% as P1). The study seeks~     to find a positive correlation between biomarkers and clinical results in retroperitoneal~     liposarcoma and leiomyosarcoma treated with the mentioned combination.~      The study involves the participation of 20 hospitals of the Spanish Sarcoma Group (GEIS). The~     treatment consists of 4 neoadjuvant cycles of nilotinib-adriamycin on patients with~     resectable retroperitoneal sarcoma. The research comprises a robust translational study as~     well as histological and radiological reviews.~   "
74852|NCT02587156|"~     12 elderly (65-70 years of age) male subjects will be included and complete a double blinded~     cross-over study. They will be habituated for 21 days to either low or high protein intake~     (below 0.8 g/kg or above 1.5 g/kg, respectively). Following a 45 day washout period they will~     switch to the alternate group. At the end of each habituation period, the investigators will~     measure the appearance of labelled amino acids from milk proteins.~   "
74853|NCT02587143|"~     Ethyl chloride vapocoolant sprays provide transient skin anesthesia within seconds of~     application. The current investigation aim is to compare the effect of ethyl chloride based~     vapocoolant spray to placebo in reducing pain associated with arterial puncture for gasometry~     determinations.~      The investigators will conduce a double-blind randomized placebo-controlled trial at~     Emergency Department.~      We will enroll patients who come to Emergency Department who need an arterial gasometry~     determination. Patients will be randomized to intervention-group (ethyl chloride vapocoolant~     sprays will be usad before arterial puncture) or to placebo-group (alcohol spray as placebo~     will be used before arterial puncture.) and after the puncture they will rate their pain~     using a 10 points visual analogue scale.~   "
74854|NCT02587130|"~     Pain is one of the major symptoms in palliative care units and often is very difficult to~     treat, being considered as a refractory pain.~      There are different causes of refractory pain: pain due to bed sores and ulcer bandages,~     carcinological or ischemic wounds or injuries, pain due to patients' reduced mobility, pain~     due to traumatological injuries, pain associated with a long-term bed confinement, etc.~      The investigators propose a prospective study to estimate the effect and the tolerance to a~     subcutaneous bolus of ketamine administered for the treatment of refractory pain due to the~     care of bedsores, ulcers and vascular wounds in patients hospitalized in palliative care~     units.~   "
74855|NCT02587117|"~     Oral lichen planus (OLP) is a common sub-acute, chronic inflammatory mucocutaneous~     disease.This study was evaluated the comparative efficacy of lycopene and prednisolone for~     the treatment of oral lichen planus. Half of participants (total number of participants was~     twenty eight) were received lycopene and the other half were received prednisolone.~   "
74856|NCT02587104|"~     A single-centered, non-randomized study with approximately 20 subjects that will be seen for~     up to 12 weeks, each receiving the EpiFix plus standard of care. Safety and effectiveness~     will be monitored throughout the study.~   "
74857|NCT02587091|"~     A cluster randomized trial was conducted across eight rural sub-counties in southwestern~     Uganda. This study was conducted to determine the impact of advertising free obstetric~     ultrasound on the attendance to antenatal care clinics.~   "
74858|NCT02587078|"~     The primary alternative hypothesis is that less time (minutes) is required, to achieve the~     initial hemodynamic stabilization, with Volulyte® compared to Jonosteril®.~        -  H01: Minutes with Volulyte® ≥ Minutes with Jonosteril®~        -  H11: Minutes with Volulyte® < Minutes with Jonosteril®~   "
74859|NCT02587065|"~     The primary objective of this study is to investigate whether Peg-IFN beta-1a improves the~     satisfaction of Relapsing-Remitting Multiple Sclerosis (RRMS) participants unsatisfied with~     injectable subcutaneous Interferons, as measured by the Abbreviated Treatment Satisfaction~     Questionnaire to Medication (TSQM-9), at 12 weeks. The secondary objectives of this study are~     to evaluate in this study population: effects of Peg-IFN beta-1a treatment on participants'~     satisfaction at 24 weeks; effects of Peg-IFN beta-1a treatment on short-term participants'~     adherence; effects of Peg-IFN beta-1a treatment on participants' fatigue; effects of Peg-IFN~     beta-1a on disease activity and physical disability; impact of Peg-IFN beta-1a treatment on~     participant-reported health-related quality of life; impact of Peg-IFN beta-1a treatment on~     participants' injection-system satisfaction; Evaluate the relationship between participants'~     satisfaction and adherence; Evaluate the relationship between participants' satisfaction and~     social-demographic factors (age, sex, employment working, level of education, etc) and~     clinical characteristics (annualized relapse rate [ARR], disability, etc.) and to evaluate~     the treatment safety and tolerability.~   "
74860|NCT02587052|"~     This is a retrospective analysis of two different cohorts of patients that has undergone~     renal transplantation. This is a matched pair analysis of 100 patients treated with generic~     tacrolimus that will be compared with 100 matched controls treated with Prograf. Data will be~     obtained from patients' charts, from the Swedish National Kidney Registry and from a local~     registry at Transplantationscentrum. Patients included in the study are patients receiving a~     first single kidney transplant from a deceased or a living donor, treated with Prograf or~     Tacni and transplanted between transplanted January 2012 and August 2014. The 1-year-outcome~     of patients following renal transplantation, including BPAR, serious adverse effects and~     graft survival will be analysed.~   "
74861|NCT02587039|"~     Patients that have cardiac surgery may suffer from unrecognized cerebral ischemia or loss of~     blood flow to the brain temporarily during surgery. This temporary loss of blood flow to the~     brain may result in a condition called delirium. Delirium is a type temporary confusion.~     There are some strategies that can help reduce cerebral ischemia during cardiac surgery which~     can help lead to a reduction in the incidence of delirium. The investigator believes that a~     strategy called remote ischemic preconditioning will help to reduce the incidence of delirium~     incidence after cardiac surgery.~      Remote ischemic preconditioning is a brief exposure to ischemia. This brief exposure to~     ischemia occurs in an area of the body that is not undergoing a procedure. This brief~     exposure to ischemia is not long enough to cause any damage to the body and it has been~     demonstrated to help protect against more severe ischemic injury that may occur later during~     surgery. In this study the investigator will use remote ischemic preconditioning to see if it~     can reduce the incidence delirium after cardiac surgery.~   "
74862|NCT02587026|"~     This is a tissue collection protocol to create an annotated biorepository to support future~     basic and translational research. The study protocol and consent will request patient~     permission to allow their specimens to be stored for future use in other~     laboratory/correlative studies without requiring a separate new consent at a future date. It~     will include also a retrospective review of all patients who have been seen or treated by the~     Precision Genomics Clinic (waiver of consent requested). No specific research studies/aims~     are included directly in this proposal. Use of the samples, data, and other resources (cell~     lines, etc.) created within this protocol will require review/approval by the majority of the~     Precision Genomics Investigators and appropriate IRB approval.~   "
74863|NCT02587013|"~     This study is designed to compare the exteriorization of the uterus versus the in situ repair~     for closure of the hysterotomy incision with a completely standardized anesthetic protocol.~   "
74864|NCT02587000|"~     Evaluation of efficiency of selective progesterone receptor modulators (SPRM) (Ulipristal~     acetate) on bleeding control and pain for patients with adenomyosis and wish to keep~     fertility.~   "
74867|NCT02586961|"~     The combined administration of high dose of oral betamethasone and nebulization of adrenaline~     seems to be an attractive therapeutic alternative for reducing the rate of hospitalization~     for acute bronchiolitis treated in the emergency department. However, it is essential to~     confirm the trend previously observed with this treatment before using it in current~     practice.~   "
74868|NCT02586948|"~     Morbidity and mortality in COPD result largely of acute exacerbations.The optimization of the~     respiratory management represents a fundamental challenge for improving prognosis and~     reducing mortality. While the hospital mortality of patients treated with NIV has decreased~     over years, and is currently less than 10 %, mortality in patients treated with invasive~     ventilation remains higher than 25%. To improve the prognosis of patients with acute~     exacerbation of COPD requiring invasive mechanical ventilation is therefore a major challenge~     in terms of morbidity and mortality. Among the means available to achieve this goal,~     minimally invasive extracorporeal CO2 removal (ECCO2R) seems to be a very promising approach.~      The investigators hypothesize that the addition of minimally invasive ECCO2R is likely to~     limit dynamic hyperinflation in COPD patients requiring invasive mechanical ventilation for~     an acute exacerbation, while improving gas exchange.~   "
74869|NCT02586935|"~     This study will examine the safety and efficacy of tideglusib vs. placebo for the treatment~     of core symptom domains in adolescents with Autism Spectrum Disorders~   "
74870|NCT02586922|"~     The aim of this study is to determine cut-off values for fetal lung volume by VOCAL and~     pulmonary artery resistance index by pulsed Doppler in fetuses of diabetic mothers, and~     correlate the results with postnatal respiratory distress of the term neonates.~   "
74871|NCT02586909|"~     This 12-month open-label study will provide further information regarding the long-term~     safety and tolerability of intepirdine (RVT-101) for subjects with Alzheimer's disease who~     have completed the double-blind, placebo-controlled, lead-in study RVT-101-3001 (double-blind~     study).~   "
74872|NCT02586896|"~     This study will compare the effects of brief strengths-based case management (SBCM) to the~     effects of screening, assessment and referral alone (SAR) in opioid-dependent patients.~     Participants meeting DSM-IV criteria for opioid dependence will be randomly assigned (150 per~     group) to receive 1) up to 6 sessions of SBCM; or 2) SAR. Follow-up assessments will be~     completed at 3 and 6 months, by staff who are blinded to treatment condition.~   "
74873|NCT02586883|"~     The purpose of this study is to identify the abnormalities of bronchial trans-epithelial~     transport of chloride, sodium and bicarbonate in patients with idiopathic dilations of the~     bronchi.~   "
74874|NCT02586870|"~     This is a prospective multicenter study based on the validation of diagnostic criteria and~     predictive factors of treatment efficacy for renal artery stenosis in renal artery dysplasia.~     This is considered as a rare disease and patients are usually treated in specialized centers~     involved in a national network. Marseille is a center specialized in FMD and a member of the~     network that is very active across the country. In order to rapidly recruit patients the~     investigators propose a multicenter study. All patients included will benefit from an~     invasive angiography with trans stenotic gradient assessment at rest. In case of bilateral~     stenosis the investigators will randomly omit data from one side and consider the data from~     the contralateral artery for further analysis, to avoid statistical interdependency. Patients~     who require angioplasty and who have unilateral stenosis (unilateral FMD lesion or bilateral~     but with one non significant stenosis based on duplex ultrasound European recommendations for~     atherosclerotic renal artery stenosis) will be included in the second part of the study.~     These patients will in addition benefit from a trans stenotic pressure assessment under~     vasodilation and intravascular renal artery ultrasound. Patients with severe bilateral renal~     artery stenosis will not be included in the analysis to assess predictive criteria for~     treatment efficacy on hypertension, treatment of these patients will followed the current~     best clinical practice. These patients will be followed during 6 to 8 month to assess~     potential complication of the pressure assessment renal artery stenosis, but their data will~     be included to assess the value of FFR and IVUS to guide the procedure. Patients with~     unilateral stenosis will be followed up 6 month after angioplasty in order to assess~     hypertension and to look for potential complications.~   "
74875|NCT02586857|"~     A Phase 1b/2, multicenter, open-label study designed to evaluate the efficacy and safety of~     ACP-196 in subjects with recurrent GBM who have progressed after 1 or 2 prior systemic~     treatment regimens.~   "
74876|NCT02586844|"~     Prospective study to obtain fresh tumor biopsies and three blood samples from patients with a~     confirmed histological or cytological diagnosis of well-differentiated neuroendocrine tumors~     (NETs) or well-differentiated pancreatic neuroendocrine tumors (PanNETs) for molecular~     profiling.~   "
74877|NCT02586831|"~     To assess whether there is a difference in endogenous insulin secretion, measured as~     stimulated C-peptide secretion (area under the curve during a 4-hour mixed meal tolerance~     test), at the 1 year visit, for study subjects receiving combinational therapy versus those~     receiving placebo. The study will also examine the effect of the proposed treatments on~     immunological outcomes, specifically proportion of regulatory T cells at the 1 year visit.~   "
74878|NCT02586818|"~     This study is designed to evaluate and verify the clinical accuracy of the InRhythm PT/INR~     system; a point-of-care, whole blood PT/INR measurement with a reference plasma based PT/INR~     using a laboratory reference instrument and reagent (Sysmex/Innovin) calibrated to the WHO~     rTF09 reference standard.~   "
74879|NCT02586805|"~     This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial to~     evaluate the efficacy and safety of DX-2930 in preventing acute angioedema attacks in~     patients with Type I and Type II HAE.~   "
74880|NCT02586792|"~     The study will be an open-label phase 2 clinical trial of a single dose of an inactivated~     H7N9 influenza vaccine (non-adjuvanted). The subjects of the study will have previously~     participated in DMID trial 07-0023, evaluating inactivated Influenza A/H7N7 vaccine. In the~     previous study healthy adults 18 to 40 years old were randomized to receive two doses, 28~     days apart, of placebo or 7.5, 15, 45, or 90 ug of the influenza vaccine by IM injection in a~     1:1 ratio (N=25/vaccine group and 25 in placebo group). The primary objectives are to 1)~     assess the safety and reactogenicity of a single dose A/H7N9 vaccine in individuals who~     previously received two IM doses of an A/H7N7 vaccine or are A/H7 vaccine-naïve and 2) To~     assess the serum hemagglutination inhibition (HAI) antibody responses against A/H7N9~     approximately 28 days following receipt of a single dose of A/H7N9 vaccine in individuals who~     previously received two IM doses of A/H7N7 vaccine or are A/H7 vaccine-naïve.~   "
74881|NCT02586779|"~     Effective communication between consulting physicians and the emergency physicians is~     critical for patients in the emergency department. The aim of this study was to determinate~     effectiveness of whatsApp usage for communication between physicians.~   "
74882|NCT02586766|"~     The purpose of this study is to determine whether a brief motivational interviewing~     intervention given during emergency department care to 14-20 year olds seeking treatment,~     could reduce youth violence.~   "
74884|NCT02586740|"~     Pulmonary artery rehabilitation procedure is done frequently in the catheterization suite for~     patients with pulmonary artery stenosis or small pulmonary arteries following surgical repair~     for patients with tetralogy of Fallot with pulmonary atresia and major aortopulmonary~     collaterals. Considering that the investigators' institution is a major center for treating~     these cases, the investigators wanted to do a retrospective review of the investigators' data~     to share the investigators' anesthetic management of these procedures.~   "
74885|NCT02586727|"~     The primary objective of the study is to assess the safety of intravitreal aflibercept~     injection in treating visually compromising radiation maculopathy secondary to treatment of~     uveal melanoma by iodione-125 brachytherapy. The study will consist of two arms of 25~     patients each (totaling 50 patients). Subjects in arm 1 will undergo treatment every 6 weeks.~     Subjects in arm 2 will undergo treatment and if improvement is documented at the following~     evaluation the next treatment will be extended by two weeks. Secondary objectives of the~     study include evaluation and analysis of visual acuity, number of injections, macular edema,~     and vascular activity between both arms.~   "
74886|NCT02586714|"~     This study examined the relationships between maternal body composition, placental function,~     and fetal nutrition and body composition, and sought to determine the most accurate method of~     maternal body composition analysis in late pregnancy.~   "
74887|NCT02586701|"~     Investigation into prehabilitation by increasing the supervision of exercise in patients~     undergoing colorectal resection for cancer and comparing with patients involved in a~     rehabilitation group receiving exercise after surgery.~   "
74888|NCT02586688|"~     To evaluate the safety and efficacy of daily, active Neurostar® TMS (when compared with sham~     treatment) in adolescents meeting criteria for Major Depressive Disorder (MDD).~   "
74889|NCT02586675|"~     The purpose of this study is to find out if the investigational drug Ribociclib (LEE011),~     when taken with standard treatment (Tamoxifen +/- Goserelin) is safe and has beneficial~     effects in pre-menopausal and post-menopausal women and men who have a type of breast cancer~     known as hormone receptor positive/HER2- breast cancer.~   "
74890|NCT02586662|"~     Background: Patterns of scapular dyskinesis have unique scapular kinematics and associated~     muscular activation. The characteristics of scapular dyskinesis may be associated with~     functional disability. The investigators investigated whether the level of shoulder function~     and primary dysfunction items were different in each unique pattern of scapular dyskinesis.~     The factors associated with shoulder dysfunction in different patterns of scapular dyskinesis~     were identified.~      Methods: Participants with unilateral shoulder pain were classified as having a single~     dyskinesis pattern (inferior angle prominence, pattern I; medial border prominence, pattern~     II) or a mixed dyskinesis pattern (patterns I+II). Clinical measurements with the Flexilevel~     Scale of Shoulder Function (FLEX-SF score), shoulder range of motion, anterior/posterior~     shoulder tightness, and pectoralis minor index were recorded. These clinical measurements,~     3-D scapular kinematics (electromagnetic-based motion analysis), and associated muscular~     activation (electromyography on the upper, middle, and lower parts of the trapezius and~     serratus anterior muscles) during arm elevation were analyzed for associations with~     functional disability.~   "
74891|NCT02586649|"~     Respiratory complications are the leading cause of death during the initial year after acute~     SCI, and the third leading cause of death thereafter. Complete or partial loss of respiratory~     muscle innervations in individuals with cervical and high thoracic injuries leads to~     inadequate ventilation and inability to effectively clear secretions, often prompting~     supportive ventilation following initial injury. Development of atelactasis, pneumonias and~     respiratory failure are the most common respiratory complications observed during the acute~     phase of injury. It is well known that a restrictive ventilatory defect, dependent upon the~     level and completeness of injury, is apparent in individuals with chronic cervical SCI.~     Respiratory functional impairment might be further compromised in these individuals, the~     majority of whom share many aspects of obstructive airway physiology commonly associated with~     asthma. The asthma-like features that individuals with chronic cervical SCI demonstrate have~     been hypothesized to be due to overriding cholinergic airway tone carried by intact vagal~     (parasympathetic) nerve fibers arising from the brainstem, whereas sympathetic innervations~     is interrupted at the level of the upper thoracic spinal cord. Whether airway narrowing and~     AHR in chronic cervical SCI is also related to chronic airway inflammation is unknown,~     although it is conceivable that repeated respiratory infections or, possibly, a neurogenic~     component, could contribute to chronic airway inflammation.~      Therefore, the investigators aim to assess how long-acting bronchodilator (tiotropium~     bromide) affects various indices of lung function, including: pulmonary function tests,~     levels of inflammation and cough strength across 24 hours after receiving study drug. Results~     will be analyzed for baseline, 1 hour, 3 hours, 20 hours and 24 hours post drug inhalation~     for both active medication and non-active placebo.~   "
74892|NCT02586636|"~     Metformin is the first-line treatment for medical management of Type 2 Diabetes. Up to 25% of~     patients experience significant gastrointestinal symptoms and in approximate 5%, side-effects~     result in the discontinuation of metformin. It would be of great clinical significance if the~     underlying cause of this intolerance was identified.~      Recent data has highlighted a metformin transporter in the gut - Organic Cation Transporter~     1(OCT1) - as a potential culprit for the variability in metformin tolerance. Across a~     diabetic population, up to one in four people were shown to have a single reduced function~     allele for OCT1, with approximately 8% having two reduced function alleles. This may increase~     the risk of the individual experiencing metformin-associated side-effects, potentially due to~     accumulation within the cells lining the intestine. The investigators aim to show that loss~     of function of OCT1, either due to genetic variation or drug inhibition of OCT1, may lead to~     an increase in the symptoms associated with metformin intolerance.~      The study is being undertaken at the Clinical Research Centre in Ninewells Hospital, Dundee.~     The investigators will recruit participants from the GoDARTS study (Genetics of Diabetes and~     Audit Research Tayside Study). The participants will be healthy controls, i.e. non-diabetic,~     and recruited according to their genotype of OCT1 (information from GoDARTS). The volunteers~     will then enter a matched cross-over study with two treatment periods. Metformin is taken~     during both treatment periods alongside either Omeprazole (a proton pump inhibitor used to~     prevent excess stomach acid, known to interact with OCT1) or placebo. The metformin dose is~     increased gradually during each period, to a maximum tolerated dose. The investigators expect~     to see a lower maximum tolerated dose in individuals with loss of function genotype, or in~     those taking concurrent omeprazole compared to placebo. The study will last approximately 9~     weeks. Volunteers have 3 visits to the CRC, and weekly phone call interviews.~   "
74893|NCT02586623|"~     To evaluate the time to treatment intervention in patients with Parkinson's Disease (PD),~     Multiple System Atrophy (MSA), Pure Autonomic Failure (PAF), Non-Diabetic Autonomic~     Neuropathy (NDAN) or Dopamine Beta Hydroxylase (DBH) Deficiency who have been previously~     stabilized with droxidopa therapy for symptoms of neurogenic orthostatic hypotension (NOH)~     (dizziness, light-headedness, or feelings that they are about to black out)~   "
74909|NCT02586415|"~     This is a study to evaluate the hypothesis that FDA cleared thrombectomy devices plus medical~     management leads to superior clinical outcomes in acute ischemic stroke patients at 90 days~     when compared to medical management alone in appropriately selected subjects with the Target~     mismatch profile and an MCA (M1 segment) or ICA occlusion who can be randomized and have~     endovascular treatment initiated between 6-16 hours after last seen well.~   "
74894|NCT02586610|"~     This is a phase II, prospective open label multi-center study in which subjects with stage~     II-III rectal cancer will be accrued in order to determine the pathological complete response~     rate of neoadjuvant pembrolizumab in combination with chemoradiation treatment (CRT).~     Subjects must have a diagnosis of rectal cancer, stage II (T3-4, N0) or stage III (any T,~     N1-2). Subjects must have received no prior treatments (chemotherapy, pelvic radiation or~     surgery) for their rectal cancer.~      Eligible subjects will receive standard chemoradiation with pembrolizumab administered every~     3 weeks on days 1, 22, and 43 of the neoadjuvant interval. In all subjects, restaging~     endorectal or pelvic MRI with chest and abdominal CT will be performed at 6-8 weeks after~     completion of neoadjuvant treatment to determine resectability and to rule out any evidence~     of metastases. Subjects who have resectable disease will undergo surgery within 2-4 weeks of~     imaging; 8-12 weeks after completion of chemoradiation. Subjects who are found to have~     unresectable or metastatic disease post treatment with the combination of CRT+ pembrolizumab~     should receive standard of care definitive treatment per the discretion of their treating~     physician.~   "
74895|NCT02586597|"~     Stroke is the third most common cause of death in the United States after heart disease and~     cancer, and the leading cause of long-term disability. This work will develop an innovative~     brain stimulation method (paired associative stimulation) which might set the stage for a new~     treatment for stroke rehabilitation.~   "
74896|NCT02586584|"~     The purpose of this Canada-France study is to develop and validate a multidimensional~     patient-reported measure of perceived barriers to antiretroviral therapy adherence for~     HIV-positive patients undergoing treatment that will be theoretically founded, easy to use~     and helpful to clinicians in their medical decision-making, in a clinical or research~     setting.~   "
74897|NCT02586571|"~     The purpose of this prospective cohort study is to investigate breast-milk and breastfeeding~     among infants who are exclusively and partially breastfed at 6 months of age in terms of~     characteristics that are hypothesised to contribute to growth and development of body~     composition in infancy.~      The scientific originality lies in the simultaneous sampling of multiple factors that are~     believed to contribute to growth and development of body composition in infancy, i.e. energy~     content of breast-milk, metabolism-regulating hormones in breast-milk, infant temperament and~     appetite. The selection of two predefined study groups, i.e. infants exclusively breastfed~     until 6 months of age and infants given complementary foods in addition to breast-milk from~     3-4 months of age, gives the opportunity to describe, and perhaps up to some point compare,~     what now is described by the World Health Organization and in official Icelandic infant~     recommendations as optimal feeding and what studies have suggested is common feeding in~     many countries. The methods are carefully chosen, i.e. appropriate and non-invasive isotopes~     and validated questionnaires are used. To our knowledge, no study has reported breast-milk~     composition in exclusively vs. partially breastfed infants.~   "
74898|NCT02586558|"~     Colic, or inconsolable crying and fussing, affects around 20% of babies who are 3 months of~     age or younger. To date, there are no known treatments that have been found to help reduce~     colic and its symptoms in babies. The investigators would like to see whether a baby formula~     that contains a prebiotic will lead to the same improvements in babies with colic. The~     investigators will test this by giving some babies a formula with the prebiotic and other~     babies a placebo formula.~   "
74899|NCT02586545|"~     The aim of the study is to test the effect of a new shared care model for type 2 diabetes~     care and compare it with a standardized care management program in a specialized~     hospital-based out-patient clinic.~      The hypothesis is that participants with type 2 diabetes followed in a shared care program~     will have a comparable outcome in HbA1c to participants receiving standard care.~   "
74900|NCT02586532|"~     Background:~      Epstein-Barr virus (EBV) can cause the cancer nasopharyngeal carcinoma (NPC). Early detection~     of NPC through screening can lead to better treatment outcomes than when it is found later.~     Currently, NPC is found through visual inspection with an endoscope. It is not clear how well~     this method works, especially for the identification of small, early cancers. Researchers~     want to see how well nasal endoscopy works to detect NPC compared to another method called~     magnetic resonance imaging (MRI).~      Objectives:~      To evaluate the sensitivity of endoscopy to detect prevalent NPC among people who screen~     positive for EBV antibodies.~      Eligibility:~      Participants of the NPC Early Detection Screening Program in China who:~      Have increased levels of EBV antibodies~      Are otherwise in good health and able to have an MRI procedure~      Design:~      Participants will be screened with a blood test.~      Participants will have a nasal endoscopy.~      Participants will have an MRI of the head and neck:~      Participants will have lesions identified by either the endoscopy or MRI biopsied and sent to~     a pathologist for review and diagnosis of NPC.~      Researchers will compare NPC detection rates by endoscopy and by MRI to see which method is~     better able to identify prevalent NPC.~   "
74901|NCT02586519|"~     Diabetic foot ulceration (DFU) is a common complication with a 25% lifetime risk in patients~     with diabetes. While most of these ulcers can be treated successfully on an outpatient basis,~     some will persist and become infected. Nearly one fifth of patients with lower-extremity~     diabetic ulcers will require amputation of the affected limb, resulting in staggering costs~     for both the patient and the healthcare system. Therapies that promote rapid and complete~     healing and reduce the need for expensive surgical procedures impact these costs~     substantially.~      The standard of care for the treatment of diabetic foot ulcers is the removable cast walker~     (RCW). RCW use has demonstrated plantar pressure reduction yet is typically perceived as~     having compliance issues due to its removable nature. In addressing this limitation, a~     modified version of the RCW has been developed by wrapping it in a layer of cohesive or~     plaster bandage. This technique has been termed the instant total contact cast (iTCC)~     derived from the seldom-used, gold standard treatment, the total contact cast (TCC). While~     ease of application and potential clinical equivalence are clear benefits, the iTCC carries~     disadvantages on account of its irremovability. For example, frequent dressing changes~     impractical, yet may be necessary for complex wound care. The goal of this research is to~     continue inquiry and innovation in this most basic aspect of care, whilst addressing the~     limitations of past research and failures in this domain.~      The investigators propose examining the capability of the SurroSense Rx® smart insole and~     smartwatch system (Orpyx Medical Technologies Inc., Calgary AB) in managing and monitoring~     adherence to plantar pressure offloading through alert-based feedback. The insoles are~     embedded with pressure sensors, which wirelessly communicate with a smartwatch that provides~     feedback on modifying activity or pressure profile over time. This smartwatch transmits~     audio, visual, and tactile notifications when excessive pressure-time thresholds under~     plantar regions of interest have been met. This feedback allows patients to be educated on~     their plantar pressure, and engages them and their caregivers to manage adherence to~     offloading. The investigators also propose comparing the healing rates of active neuropathic~     ulcers using RCWs coupled with the SurroSense Rx® smart insole system to assess whether~     adjunctive use of the two interventions improves the efficiency of neuropathic ulcer~     treatment.~   "
74902|NCT02586506|"~     Asthma is a chronic disease of the lungs characterized by airway inflammation,~     bronchoconstriction and increased airway responsiveness. Inhaled corticosteroids (ICS), alone~     or in combination with inhaled long-acting beta-adrenergic agonists (LABA), are considered a~     mainstay of treatment for treatment. For inhaled medications, the choice of inhalation device~     is an important consideration because an inadequate technique reduces the delivery of~     medicines and effects of inhalation. Therefore, the development of an easy-to-use inhaler~     that delivers the drug to the lungs effectively, is important. This study is designed to~     assess the correct use of the ELLIPTA inhaler in subjects with asthma and also to assess ease~     of use of the ELLIPTA inhaler, as rated by those subjects determined to be using the inhaler~     correctly. Study will be divided into two visits i.e. Screening/Visit 1 (day 1) and Visit 2~     (Day 28 +/-2) with a phone call on Day 8+/-2 days of Visit 1 to assess safety. In this~     multi-center, single-arm, randomised (to receive one of two versions of the ELLIPTA inhaler~     Ease of Use questionnaires), open-label, placebo study, only subjects who are have never used~     the ELLIPTA inhaler before and have an established diagnosis of asthma and receiving asthma~     therapy and are able to demonstrate correct use of the ELLIPTA inhaler at Visit 1 will be~     considered eligible to participate in this study. Approximately 252 subjects will be screened~     with an expectation of 208 subjects completing the study while demonstrating correct ELLIPTA~     inhaler use at visit 2.~      ELLIPTA is a registered trademark of the GlaxoSmithKline Group of Companies.~   "
74903|NCT02586493|"~     Chronic obstructive pulmonary disease (COPD) is a preventable and treatable disease~     characterized by airflow limitation that is not fully reversible. The mainstay for treatment~     involves the use of inhaled medications, including short and/or long-acting bronchodilators~     along with inhaled corticosteroids. For inhaled medications, the choice of inhalation device~     is an important consideration because an inadequate technique reduces the effects of~     inhalation. Therefore, the development of an easy-to-use inhaler that delivers the drug to~     the lungs effectively, is important. This study will assess the correct use of the ELLIPTA~     inhaler by subjects with COPD and to assess ease of use of the ELLIPTA inhaler, as rated by~     those subjects determined to be using the inhaler correctly. Study will be divided into two~     visits i.e. Screening/Visit 1 (day 1) and Visit 2 (Day 28 +/-2) with a phone call on Day~     8+/-2 days of Visit 1 to assess safety. In this multi-center, single-arm, randomised (to~     receive one of two versions of the ELLIPTA inhaler Ease of Use questionnaires), open-label,~     placebo study, only subjects who are have never used the ELLIPTA inhaler before and have an~     established diagnosis of COPD and receiving COPD therapy and are able to demonstrate correct~     use of the ELLIPTA inhaler at Visit 1 will be considered eligible to participate in this~     study. Approximately 252 subjects will be screened with an expectation of 208 subjects~     completing the study while demonstrating correct ELLIPTA inhaler use at visit 2.~      ELLIPTA is a registered trademark of the GlaxoSmithKline Group of Companies.~   "
74904|NCT02586480|"~     Observational study on long PR interval using the SafeR mode in bradycardia patients.~   "
74905|NCT02586467|"~     Over 35,000 Canadians, 65% of men and 72% of women aged 31-50 years fail to consume the~     recommended number of milk and milk product servings (≤2 servings per day). Given the wide~     range of health benefits associated with increased dietary intake of milk and milk products~     the objectives of this study were to conduct a prospective, 5-arm randomised controlled trial~     in order to test the effectiveness of a variety of messages for increasing milk and milk~     product consumption in men and women aged 30-50 years old. The five arms consisted of 4~     messages that contained slightly different content specifically: 1) gain-framed message~     condition, 2) loss-framed message condition, 3) self-regulatory efficacy-enhancing message~     condition, 4) gain-framed and self-regulatory efficacy-enhancing message condition and 5)~     loss-framed plus self-regulatory efficacy-enhancing message condition. It was hypothesised~     that those who receive self-regulatory efficacy-enhancing information would consume more~     dairy than those who received messages without such information. Second, those who received~     gain-framed messages would consume more dairy as compared to those who received loss-framed~     messages. Third, those who received gain-framed messages that include self-regulatory~     efficacy-enhancing information would consume the most dairy in comparison to the other four~     conditions.~   "
74906|NCT02586454|"~     Patients who have undergone laparotomies often require multimodal postoperative pain regimes.~     In recent years, abdominal wall blocks have been included to become part of this in order to~     overcome side effects of systemic opioids and complications from epidural analgesia.~      Borglum popularised a new approach on abdominal wall blocks by introducing the transmuscular~     quadratus lumborum (QL) block. Transmuscular QL block is thought to be effective against~     somatic and visceral pain as local anaesthetic tends to spread from the site of injection to~     thoracic paravertebral spaces where the sympathetic chain lies.~      The objective of this study is to evaluate the analgesic efficacy of transmuscular QL block~     in patients undergoing total abdominal hysterectomy (TAH) by measuring cumulative opioid~     consumption, pain score at rest and on movement 24 hours after TAH. Our hypothesis is~     patients given transmuscular QL block will have lower cumulative opioid consumption.~   "
74907|NCT02586441|"~     The BIS Index, one of the VISTA Monitor output parameters, may be used as an aid in~     monitoring the effects of certain anesthetic agents;and its usage with certain anesthetic~     agents may be associated with a reduction in primary anesthetic use and a reduction in~     emergence and recovery time.~      However, this equipment does not give the proper anesthetic depth index is a number of~     experimental results have been reported.~      Therefore, the investigators study that the BIS VISTA receives an electroencephalogram (EEG)~     obtained through the depth of anesthesia monitors brain waves to collect statistical data,~     through mathematical analysis to analyze the exact correlation between the patient's brain~     waves and the depth of anesthesia.~   "
74908|NCT02586428|"~     Before and after a patient receives genetic counseling they will be offered the chance to~     complete the survey, by their counselor. Since each patient sees only one genetic counselor~     that counselor will be responsible for consenting and giving and collecting the finish~     surveys. No identifiers will be used. The investigators will emphasize that their answers~     will remain anonymous throughout the entire process, and that their participation is strictly~     voluntary. The patient will be provided with a survey and asked to complete this before their~     genetic counseling session and after.The survey will be returned to the genetic counselor and~     placed in a locked drawer. Information will also be collected from the medical record~     including age, pregnancy history and the reason for the visit.~   "
74912|NCT02586376|"~     The low-level laser therapy (LLLT) has been used in many inflammatory disorders. More~     recently the LLLT was associated with an improvement in the muscle strength and endurance.~     But, these effects were described only in health or athletic individuals. In this randomized~     and controlled clinical trails, the investigators will study the effects of LLLT on muscle~     strength of the patients with kidneys failure on long time hemodialysis treatment.~     Additionally, investigators will explore three different intensities up the muscle strength.~   "
74913|NCT02586363|"~     In this clinical trial, the investigator will clarify the difference in pharmacokinetics~     between the group single dose Cavir Tab. 0.5mg and single dose Cavir Tab. 0.5mg with high~     fatty meal for healthy adult volunteer.~      The investigators evaluate the effect of food intake on the absorption of Cavir Tab. 0.5mg.~   "
74914|NCT02586350|"~     To compare the effects and safety of Anlotinib with placebo in patients with Medullary~     Thyroid Carcinoma.~   "
74915|NCT02586337|"~     The purpose of this study is to compare the effects and safety of Anlotinib with placebo in~     patients with Differentiated Thyroid Cancer.~   "
74916|NCT02586324|"~     In this research, the two media used are Global medium and SSM medium with serum), which are~     routinely used in the reproduction biology unit. This study simply consists in setting up a~     methodology to compare these to media. The only constraint placed on patients is to accept~     randomization for the type of medium used.~   "
74917|NCT02586311|"~     Trial to Evaluate the Efficacy and Safety of a CKD-330 versus Amlodipine Monotherapy in~     Hypertensive Patients Inadequately Controlled by Amlodipine Monotherapy~   "
74918|NCT02586298|"~     The principle objective is to improve embryo quality through autologous micro-injection of~     mitochondria isolated from Ovarian stem cells into the oocytes themselves, as a complementary~     ICSI technique in patients with low embryo quality in previous IVF cycles and in those who~     did not bear children.~      This improvement in embryo quality will be determined through on-going pregnancy rate after~     treatment and/or improvement in embryo quality according to morphological~     (ASEBIR-Association for the study of Biology in Reproductive Science), morphokinetic~     criteria and in Preimplantation Genetic Screening.~      Using an adaptive design, retrieved oocytes of approximately 60 patients will be randomized~     in the first part of the study to two treatment groups; standard ICSI procedure without~     mitochondrial supplementation and ICSI with autologous mitochondrial supplementation.~     Following an interim analysis of outcomes, an additional 130 patients may be added, for a~     total of 190 patients.~   "
74919|NCT02586285|"~     The aim of this study is to explore the effect of S-Adenosyl Methionine on recurrence after~     curative resection of Hepatocellular Carcinoma.~   "
74920|NCT02586272|"~     Prospective, single-center, single-blind, randomized, controlled, two-arm, interventional~     study.~   "
74921|NCT02586259|"~     The purpose of this study is to evaluate Cortiment® with regard to its use by clinicians in~     routine clinical practice and its effectiveness and tolerability in a real-life setting.~   "
74922|NCT02586246|"~     The objective of this study is to evaluate the safety and efficacy of CDP870 self-injection~     administered for 24 weeks or longer in subjects who are participating in the long-term~     treatment study (Study 275-08-002 or Study 275-08-004) of CDP870 administered concomitantly~     with or without Methotrexate.~   "
74923|NCT02586233|"~     This is a Phase 1b/2, double-blind (Principal Investigators and study subjects blinded,~     Sponsor unblinded), placebo-controlled, randomized, single-ascending dose, multi-center study~     to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of~     DS-1040b in subjects with Acute Ischemic Stroke (AIS).~   "
74924|NCT02586220|"~     Recent studies have found, in both developed and developing countries, there is still a~     considerable number of pregnant women in iodine deficiency status.Our overall aim is to~     monitor iodine status of pregnant women in China, and to examine the correlation between~     maternal urine iodine concentration (UIC) and newborn physical development level.~   "
74925|NCT02586207|"~     This is a single-arm, multi-site, open-label trial of pembrolizumab (MK-3475) used in~     combination with standard, cisplatin-based, definitive chemoradiotherapy (CRT) in patients~     with stage III-IVB squamous cell carcinoma of the head and neck (SCCHN). Approximately 39~     patients with Stage III-IVB SCCHN will be enrolled to evaluate both the safety and efficacy~     of this novel combination. Subjects will not be randomized and will all receive the study~     treatment.~      Treatment will consist of a loading dose of pembrolizumab 200 mg IV given 7 days prior to~     initiation of CRT (day-7). CRT with cisplatin 40 mg/m2 IV weekly and head and neck radiation~     at 70 Gy fractionated at 2 Gy once daily over 35 days, will begin on day 1. CRT will end on~     approximately day 46-50. Pembrolizumab 200 mg IV will continue following CRT in an adjuvant~     fashion starting on day 57 for an additional 5 doses, as tolerated, through day 141. Subjects~     will be evaluated for response following treatment.~   "
74926|NCT02586194|"~     The objective of this study is to compare and evaluate the pharmacokinetics of ASP015K in~     patients with impaired hepatic function and subjects with normal hepatic function.~   "
74927|NCT02586181|"~     The standard recommendation to prevent osteoporosis is to supplement low doses of vitamin D~     and calcium. Hyperhomocysteinemia has been related to increased risk of osteoporosis.~   "
74928|NCT02586168|"~     The purpose of this study is to determine the effect of gemcabene on insulin sensitivity as~     defined by average glucose disposal rate.~   "
74929|NCT02586155|"~     The purpose of this study is to determine whether bromodomain extraterminal domain (BET)~     inhibition treatment with RVX000222 in high-risk type 2 diabetes mellitus patients with~     coronary artery disease increases the time to major adverse cardiovascular events.~   "
74930|NCT02586142|"~     Claw toes deformity result in spasticity often seem in patients with central nerve disease.~     It also cause pressure sore in foot and pain during walking that didn't well improve under~     traditional treatment. There are few relative reports about the Botulinum toxin type A~     (BTX-A) injection on claw toe. The investigators' study has two main purposes:~        1. assess the efficiency of BTX-A injection under ultrasonographyic guidance on improving~          lower extremities function, pain and spasticity in patients with symptomatic claw toes.~        2. assess if regular stretching exercise can strength the efficiency of BTX-A injection on~          improving lower extremities function, pain and spasticity.~   "
74931|NCT02586129|"~     Randomized, double-blind, active-controlled, multicenter phase 3 trial to evaluate the safety~     and efficacy of YH14755 in subjects with dyslipidemia and Type II Diabetes.~   "
74932|NCT02586116|"~     This is a post-market, prospective, randomized clinical investigation to evaluate the~     performance of the nanOss Cervical Interbody Fusion (IBF) device with nanOss Bioactive Bone~     Void Filler for the treatment of cervical disc disease. A secondary objective is to compare~     the performance of the nanOss Cervical IBF Device and nanOss Bioactive Bone Void Filler with~     the performance of the C-Plus PEEK IBF Device with autograft. This study will enroll 40~     patients at one (1) site. After subjects have signed an informed consent, they will be~     randomly assigned to either the nanOss Cervical IBF device arm or the C-Plus PEEK IBF Device.~     Patients will complete the preoperative visit and examinations. Patients will be evaluated at~     discharge, six (6) weeks, three (3) months, six (6) months, and twelve (12) months. Patients~     will be evaluated at twenty-four (24) months post-operatively if they have not demonstrated~     fusion at the 12 month time point.~   "
74933|NCT02586103|"~     The mYPAS (Modified Yale Preoperative Anxiety Scale) is a quick, easy, validated and gold~     standard assessment tool to measure pediatric anxiety in the perioperative period. Therefore~     the objective of the current prospective study is examine if the mY-PAS is an effective~     screening tool to differentiate patients who would succeed versus fail for MRI without~     sedation/anesthesia.~   "
74934|NCT02586090|"~     The study will pilot a randomized control trial to investigate the feasibility and~     preliminary efficacy of two distinct parent treatments on a dietary intervention for~     overweight and obese adolescents.~   "
74935|NCT02586077|"~     The purpose of this study is to review the use of surgeon applied liposomal release~     anesthetic (Exparel) for post operative analgesia.~      Hypothesis: Surgeon applied use of liposomal related anesthetic provides excellent post~     operative analgesia. Immediated and 72 hour narcotic use will be significantly impacted by~     the use of this modality.~   "
74936|NCT02586064|"~     Interpersonal problems such as relationship conflict and social isolation are common among~     Veterans with PTSD and serve as barriers to successful posttraumatic adjustment. The main~     interventions for PTSD at VA facilities, i.e., Prolonged Exposure, Cognitive Processing~     Therapy, and Trauma-Focused CBT, do not directly target these relationship difficulties and~     many Veterans do not complete these treatments. Couple and family approaches for PTSD address~     relationship problems, but logistical problems make it difficult for couples to attend~     sessions and these approaches do not involve Veterans who are socially isolated or unmarried.~     There is accumulating evidence that Interpersonal Psychotherapy (IPT) for PTSD may be~     effective in reducing symptoms and improving interpersonal functioning. This study, a~     randomized controlled trial, aims to provide evidence regarding whether IPT for PTSD could be~     a useful addition to current treatments delivered at the VA.~   "
74937|NCT02586051|"~     This is a Phase Ib, open-label study of single and repeat doses of obinutuzumab administered~     as intravenous (IV) infusion in adults with end stage renal disease (ESRD). Participants will~     be enrolled into two cohorts receiving either one (Cohort 1) or two or more (Cohort 2)~     obinutuzumab infusions. Both cohorts will receive standard pretreatments to reduce the risk~     of infusion-related reactions (IRRs).~      Desensitization Period: In Cohort 1, participants will receive single dose obinutuzumab IV~     infusion on Day 1. Following review of Cohort 1 aggregated safety data up to 4 weeks post~     dose for the last participant of Cohort 1, Cohort 2 will be allowed to proceed. In Cohort 2,~     participants will receive obinutuzumab IV infusion on Days 1 and 15. Transplantation Period:~     Participants who qualify for transplantation and receive a compatible kidney offer after~     inclusion in Cohort 1 or Cohort 2 will receive two additional infusions (one at the time of~     transplantation and second at Week 24 post-transplantation) of obinutuzumab. Assessment of~     the safety and tolerability of the obinutuzumab regimen will be conducted at Week 24 of the~     desensitization phase and at Week 28 post-transplantation. All participants will be monitored~     for a minimum of 12 months following the last obinutuzumab infusion.~   "
74938|NCT02586038|"~     This study will evaluate the safety and the efficacy of the MLN-DEXAMETHASONE,~     MLN-DEXAMETHASONE-CYCLOPHOSPHAMIDE, or MLN- THALIDOMIDE-DEXAMETHASONE induction combinations,~     followed by MLN maintenance in newly diagnosed elderly Multiple Myeloma patients.~      183 patients, males and females, older than 65 years old or younger but considered not~     eligible for high-dose chemotherapy and transplantation, enrolled in different sites, will~     take part in this study.~      The duration of the study is approximately 5 years.~   "
74939|NCT02586025|"~     This is an Asia-Pacific regional, randomized, double-blind, multicenter trial designed to~     evaluate treatment with trastuzumab + pertuzumab + docetaxel compared with trastuzumab +~     placebo + docetaxel in chemotherapy-naïve participants with early-stage or locally advanced~     HER2-positive breast cancer. The anticipated treatment duration is approximately 17 months.~   "
74940|NCT02586012|"~     Hemophilia A is an inherited (genetic) disease where a protein, factor VIII (FVIII), which~     promotes blood clotting is missing or does not work properly. Individuals with hemophilia A~     are at risk for bleeding. Bleeding is prevented and/or treated with recombinant factor VIII~     (rFVIII), which is an FDA-approved treatment for Hemophilia A. Obesity is common among~     patients with hemophilia. Some studies have shown that obese hemophilia patients may be able~     to prevent bleeding with a lower dose of clotting factor than the dose they are currently~     receiving. The lower dose is calculated based on what a patient should weigh rather than what~     he does weigh. This is a clinical research study to test whether calculating rFVIII dosing~     based on lean body mass and ideal body weight (what a person should weigh based on his~     height) in overweight and obese patients with hemophilia is more accurate than calculating~     rFVIII dosing based on what a person actually weighs.~   "
74941|NCT02585999|"~     Investigators propose a descriptive pharmacokinetic study of the serum hormone levels of~     estrogen and progesterone with extended use (12 weeks) of the contraceptive patch. The~     primary objective is to assess the change in serum ethinyl estradiol (EE2) levels over 12~     weeks of continuous contraceptive patch use. The secondary objective is assessing the the~     norelgestromin (NGMN) levels over the 12 weeks of continuous contraceptive patch use.~   "
74942|NCT02585986|"~     The aim of the study is to evaluate the beneficial effect of a probiotic preparation with an~     antiinflammatory and modulating activity on immunological processes, with positive results on~     different inflammatory and atopic conditions.~   "
74943|NCT02585973|"~     This open label, single-arm, Phase 1b study is designed to identify the maximum tolerated~     dose (MTD) using a traditional 3+3 dose escalation design of the WEE-1 inhibitor AZD1775 when~     added to standard of care chemotherapy (cisplatin) and radiation for the treatment of locally~     advanced squamous cell cancer of the head and neck (HNSCC).~   "
74945|NCT02585947|"~     The objective of this study is to analyze factors affecting Hepatitis B Virus (HBV)~     reactivation in anti-HBc positive patients with Non-Hodgkin's lymphoma treated with rituximab~     and compare HBV reactivation rates by duration of prophylactic treatment with tenofovir to~     contribute to the establishment of an effective prevention strategy.~   "
74946|NCT02585934|"~     This study seeks to confirm a demonstrated treatment effect of intepirdine (RVT-101) as an~     adjunctive therapy to donepezil for the treatment of subjects with Alzheimer's disease.~   "
74947|NCT02585921|"~     The number of persons actively waiting on the national solid organ waiting list continues to~     rise while the number donating organs has failed to keep pace. This is a particular problem~     for some portions of northeastern Ohio where the donation rate is as low as 32%. Adolescents~     are an important group for organ donation efforts as they have not yet applied for a driver's~     license and represent the majority of future donors. Yet many organ donation interventions~     have not targeted adolescents. The investigators propose to utilize existing high school teen~     summits developed by our Consortium partners to evaluate the effectiveness of existing~     donation interventions. Together, the investigators will conduct a randomized controlled 2x2~     factorial trial to evaluate the independent and combined effects of two donor education~     interventions on consent for organ donation on the electronic Ohio Donor Registry. One~     thousand six hundred students over the age of 15.5 years from Cleveland-area high schools~     will be enrolled.~   "
74948|NCT02585908|"~     In this study, safety and effects of γδT cells on human gastric cancer are going to be~     investigated.~   "
74949|NCT02585895|"~     To evaluate the efficacy of subcutaneous (SC) evolocumab, compared to regularly scheduled~     low-density lipoprotein cholesterol (LDL-C) apheresis, on reducing the need for future~     apheresis.~   "
74950|NCT02585882|"~     This was a block-randomized, controlled, open-label trial and was executed in two preschools~     in The Gambia. Fluoridated table salt (250 mg F/kg salt) was administered in daily communal~     preschool feeding. In total, 304 children in the test group and 137 children in the control~     group, aged 3 to 5 years were enrolled according to inclusion criteria (complete primary~     dentition and a parental or legal guardian informed consent). Mean difference of incidence of~     cavitated carious lesions (Δd3/4mft) after 12 months was the primary end point. The relative~     preventive dental caries effect was. Secondary end points were the difference of incidence of~     white spot lesions and the difference of incidence of total carious lesions.~   "
74951|NCT02585869|"~     The purpose of this study is to evaluate the effect of gemcabene on HDL‐C, LDL‐C, TG, and~     other lipid levels in patients with low HDL‐C~   "
74952|NCT02585856|"~     The aim of this study is to investigate the efficacy of photodynamic therapy (PDT) in~     increasing the survival time, decreasing cholestasis and improving health-related quality of~     life (HRQoL) by comparing PDT puls stents versus stents alone in patients with unresectable~     cholangiocarcinoma,and to assess the safety of PDT by observing the complications after the~     procedure.~   "
74953|NCT02585843|"~     This is a prospective, single-center, double-blind and randomized placebo controlled trial~     for evaluation of a 7-day 100mg daily dose of spironolactone on weight loss and resolution of~     signs and symptoms of congestion in outpatients with acute decompensated heart failure~     (ADHF). Patients who are not responding to their current loop diuretics will be considered~     for this study. Mineralocorticoid receptor antagonists (MRAs) are recommended as standard of~     care in management of heart failure (HF) patients. However, recommended doses of MRAs~     (spironolactone 25mg/daily or eplerenone 50mg/daily) will not have any impact on signs and~     symptoms of volume overload. Therefore, the proposed study will aim to show the impact of~     this outpatient regimen to improve diuresis and possible reduction in hospitalization for~     further diuretic management in HF patients with signs and symptoms of congestion.~   "
74954|NCT02585830|"~     This study examines the relationship between sleep timing and insulin resistance in~     adolescents with obesity. The investigators also aim to develop a physiologically-based~     mathematical model of adolescent sleep/wake and circadian interactions.~   "
74955|NCT02585817|"~     This is a pilot study to assess barriers, evaluate and implement a patient oriented CIED~     management model incorporating advanced technological innovation to promote a paradigm shift~     to patient-centered care involving remote CIED monitoring and programming. The advancement in~     technology is very important as it addresses several potential gaps and barriers in the care~     of patients with CIEDS:~        1. Long, expensive travel for patients~        2. Morbidity to patients due to delay in receiving appropriate treatment~        3. Efficiency in health care delivery~        4. Patient satisfaction~   "
74956|NCT02585804|"~     Patients with Focal Segmental Glomerulosclerosis (FSGS) constitute an increasing proportion~     of the total glomerulonephritis (GN) patient cohort in North America while FSGS is a risk~     factor for end stage renal failure. Current non-immunological FSGS therapies include the use~     of angiotensin converting enzyme inhibitors (ACEi) or angiotensin II receptor blockers (ARB),~     to reduce intraglomerular hypertension. Unfortunately, these agents lead to incomplete renal~     protection. The aim of the current study is to determine whether the addition of novel sodium~     glucose cotransport-2 inhibitors (SGLT2i) to standard of care leads to reduced~     intraglomerular pressure and suppression of proteinuria. We hypothesize that combination~     therapy of SGLT2i drugs and conventional RAASi results in additive renal protective effects~     in FSGS patients. A further goal is to examine mechanisms of SGLT2 inhibition by measuring~     renal hemodynamic function and sodium handling. Kidney function will be assessed in FSGS~     patients before and after an 8 week treatment with SGLT2i dapagliflozin.~   "
74957|NCT02585791|"~     This aim will examine the acute and subacute exposures to electronic cigarette (EC) vapor~     generated from e-liquids without nicotine (NFEC) on life-time non smokers subjects by~     measuring changes in nasal ion transport and TGF-β levels. Nasal ion transport will be~     assessed by nasal potential difference (NPD). Tumor growth factor (TGF)-β levels (mRNA and~     protein by ELISA) will be assessed on nasal cells and lavages.~   "
74966|NCT02585674|"~     Primary Objective:~      To demonstrate the non-inferiority of the MyStar DoseCoach (Long-acting Insulin Glargine~     Titration Meter) device-supported treat-to-target regimen relative to a routine titration~     regimen in the percentage of patients reaching glycemic target, ie, with a mean fasting~     self-monitored plasma glucose (FSMPG) value within the target range of 90-130 mg/dL (5.0-7.2~     mmol/L) without a severe hypoglycemic episode during the 16-week on-treatment period.~      Secondary Objective:~      To assess the efficacy, safety, and adherence/satisfaction of MyStar DoseCoach~   "
74958|NCT02585778|"~     Primary Objectives:~        -  To demonstrate the superiority of alirocumab in comparison with placebo in the reduction~          of calculated low-density lipoprotein cholesterol (LDL-C) in participants with diabetes~          treated with insulin and with hypercholesterolemia at high cardiovascular risk not~          adequately controlled on maximally tolerated LDL-C lowering therapy.~        -  To evaluate the safety and tolerability of alirocumab in participants with diabetes~          treated with insulin.~      Secondary Objective:~      To demonstrate that alirocumab was superior in comparison to placebo in its effects on other~     lipid parameters (i.e., measured LDL-C, non-high-density lipoprotein cholesterol [non-HDL-C],~     apolipoprotein B [Apo B], total cholesterol [TC], lipoprotein a [Lp(a)], high density~     lipoprotein cholesterol [HDL-C], triglyceride [TG] levels, triglyceride rich lipoproteins~     [TGRL], apolipoprotein A-1 [Apo A-1], apolipoprotein C-III [Apo C-III], and LDL particle~     number and size).~   "
74959|NCT02585765|"~     Pressure ulcers (PU) are skin breakdowns that often form after blood flow in the skin is~     reduced from prolonged and repeated exposure to externally applied forces. As many as 85% of~     individuals with a spinal cord injury (SCI) report the occurrence of at least 1 PU since~     being injured. Despite the increasing attention and emphasis on prevention, PUs still~     represent a major health risk for persons with SCI. Among the numerous potential physical~     risk factors identified for the development of a PU were several conditions that have a~     significant negative effect on skin blood flow. In addition, improper management of blood~     sugar is a major risk factor for PU development and it impedes healing. It would appear that~     hormones (i.e., chemical signals in the blood) associated with how the body uses sugar that~     target the blood vessels may play an important role in the development and formation of a PU.~     In persons with SCI, skin blood flow responses to insulin (i.e., a hormone that helps the~     body use sugar and also relaxes the blood vessels allowing blood flow to increase) in the~     lower extremity were shown to be much lower than healthy individuals.~      The proposed study in up to 30 individuals with chronic SCI and a difficult-to-heal pelvic~     region PU has 2 phases: (1) a 4-week observation phase [if the PU does not heal~     appropriately (determined by digital photos and software computation), and the subject is~     found to be insulin resistant then they will progress to the next phase of the study] and (2)~     an 8-week treatment phase. All participants will continue to receive the standard wound~     care throughout the observation and treatment phases. If the surface area of the PU does not~     decrease by more than 30% during the 4-week observation phase, the participant will be~     eligible to enter the 8-week treatment phase, in which they will be randomly assigned to~     receive active drug (e.g., pioglitazone) or placebo. The participants will have four study~     visits in which the following will be acquired: digital image of the wound to monitor wound~     surface area, skin blood flow measurements of the peri-wound area, and blood tests to monitor~     liver function, kidney function, blood sugar (hemoglobin A1C, insulin, glucose), nutritional~     status (albumin and pre-albumin), a complete blood count with differential, and makers of~     inflammation. Weekly monitoring of symptoms and participant experiences will be closely~     monitored.~   "
74960|NCT02585752|"~     Dynamic pulmonary hyperinflation (DH) and intrinsic positive end-expiratory pressure (PEEP)~     are well known problems in COPD patients with acute and chronic respiratory failure.~     Measurement of intrinsic PEEP level during both, invasive and non-invasive ventilation is of~     major importance since in some circumstances (e.g. during exercise or during exacerbations)~     it can significantly increase respiratory workload of COPD patients. Extrinsic PEEP applied~     during both, invasive and noninvasive ventilation is used to overcome intrinsic PEEP and~     therefore to avoid or reduce dynamic hyperinflation.~   "
74961|NCT02585739|"~     Cluster headache (CH) is a rare, excruciating primary headache disorder. A genetic basis has~     been suggested by family and twin studies, but the mode of transmission seems to vary and the~     amount of heritability is unclear.~      The number of genetic association studies investigating variants implicated in the~     pathophysiology of CH is limited. The HCRTR2 1246G > A and the ADH4 925A > G polymorphisms~     have been associated with CH. The former has been confirmed and may affect the hypothalamic~     hypocretin system. The aim of the present study was to investigate the possible link between~     SPINK 1 gene and cluster headache.~   "
74962|NCT02585726|"~     The VenaSeal Closure system offers an outpatient treatment option for the permanent closure~     of lower extremity superficial truncal veins, such as the great saphenous vein (GSV), through~     endovascular embolization with coaptation. VenaSeal is intended for use in adults with~     clinically symptomatic venous reflux as diagnosed by duplex ultrasound (DUS).~   "
74963|NCT02585713|"~     This randomized phase III trial studies the side effects of and compares apixaban and~     dalteparin in reducing blood clots in patients with cancer-related venous thromboembolism.~     Venous thromboembolism is a condition in which a blood clot forms in a vein and then breaks~     off and moves through the bloodstream. Patients with cancer are at increased risk for venous~     thromboembolism. Apixaban and dalteparin are drugs used to prevent blood clots from forming~     or to treat blood clots that have formed. It is not yet known whether apixaban or dalteparin~     is more effective in reducing blood clots in patients with cancer related venous~     thromboembolism.~   "
74964|NCT02585700|"~     This is a phase I, double-blind, randomized, placebo-controlled trial with two groups of~     participants to receive seasonal trivalent split, inactivated influenza vaccine (A/H1N1;~     A/H3N2 and B) or placebo (phosphate buffered saline). A total of 60 healthy male and female~     adults 18 through 45 years of age will be randomized to receive vaccine (30) or placebo (30).~   "
74965|NCT02585687|"~     Hepatocellular carcinoma (HCC) is the fifth most common cancer worldwide with an incidence of~     500 000 cases per year. HCC most commonly appears in a context of liver chronic disease~     (patient with chronic viral hepatitis (hepatitis B or hepatitis C) or with cirrhosis).~     Surgical resection and liver transplantation concern patients with early stage and are the~     only curative treatments. Transcatheter arterial chemoembolization, Radiation Therapy and~     antiangiogenics treatments concern patients with inoperable lesions (palliative treatments).~      Antiangiogenic treatments enable to inhibit the angiogenesis process and thus interrupt the~     blood supply to the tumor. In clinical practice, the efficacy of anti-angiogenic agents is~     usually assessed by methods based on morphological medical imaging. The measures of each~     target lesion are obtained by Response Evaluation Criteria In Solid Tumor (RECIST) criteria~     and WHO.~      However, these morphological measures are not fully evaluated. An alternative to these is the~     functional medical imaging which assess changes before that a diminution of tumor size is~     detectable. Since these treatments induce generally necrosis without modification of initial~     tumor size, the new technologies of functional medical imaging are particularly adapted to an~     early evaluation of the response to treatments which may improve patient management.~      In this context, liver Perfusion MRI needs to be assessed in its capacities to early predict~     the response of antiangiogenic treatments.~      Positive results will enable to adapt therapy in order to improve overall survival of~     patients and avoid expensive treatments which may turn out to be inefficient and generating~     important side-effects.~   "
74967|NCT02585661|"~     Determination of fractional iron absorption from dairy product fortified with 2 labelled iron~     compounds~   "
74968|NCT02585648|"~     Dry eye syndrome is a highly prevalent ocular disease with an increasing incidence in the~     elderly population. Topically administered lubricants are the basis for treatment of this~     disease.~      Relief of symptoms in patients with moderate to severe dry eye disease is usually reached by~     the use of artificial tears during the day. Nighttime relief is often achieved by substances~     known to be more adhesive to the ocular surface, such as gels.~   "
74969|NCT02585635|"~     The MOrPH study is designed to identify optimal prophylaxis schedules for children with~     haemophilia. This involves development of combined pharmacokinetic and pharmacodynamic~     models. Interpretation of model outputs will be informed by two surveys. The first will~     survey families of children with haemophilia to ascertain families' values and preferences~     concerning prophylaxis schedules. The second will survey haemophilia physicians to ascertain~     the criteria physicians use to prescribe prophylaxis schedules.~   "
74970|NCT02585622|"~     The study will investigate, primarily, the safety, feasibility and tolerability and,~     secondarily, the preliminary efficacy of an allogeneic bone marrow-derived Mesenchymal~     Stromal Cell (MSC) therapy (ORBCEL-M) in study subjects with type 2 diabetes (T2D) and~     progressive diabetic kidney disease (DKD).~   "
74971|NCT02585609|"~     The primary focus of this clinical study is the objective and subjective measurements of~     sleep quality in patients with advanced cancer using opioids. It also examines sleep~     disturbances and associations between sleep quality and symptoms in order to improve symptom~     management in patients with advanced cancer.~      The overall aim of this study is to improve the clinical understanding of sleep quality in~     patients with advanced cancer using opioids and to improve the understanding of how sleep~     quality may best be measured in order to improve symptom management.~   "
74972|NCT02585596|"~     This study is designed to evaluate the efficacy and the safety of YH23537 in Korea patients~     with chronic periodontitis, in order to investigate the recommended therapeutic dose.~   "
74973|NCT02585583|"~     The gamma knife radiosurgical thalamotomy to treat many movement disorders is recently~     becoming a new and well defined treatment paradigm.~      The CyberKnife if compared to the frame-based radiosurgery, is a pain free procedure which~     offers the advantage of a better patient's compliance by avoiding local anaesthesia and the~     discomfort due to wearing the frame for the period of time needed for the whole procedure.~      Unfortunately the subtle but substantial differences about the 3D dose distribution and the~     dose fall-off features between GK and CK made mandatory investigations about the~     effectiveness and the safety when the cyberknife is used.~      Particularly the minimum effective and safety dose have to be defined yet A previous study~     (NCT02095600) failed in demonstrating the efficacy of 75 Gy, 80 Gy, 90 Gy.~      The aim of the present study is to investigate about the effectiveness of 100 Gy, 120 Gy, 130~     Gy and 140 Gy.~      The safety and the targeting methodology will be also in investigated.~   "
74974|NCT02585570|"~     The purpose of this study is to determine whether phenylephrine infusion are effective in the~     prevention of hypotension after changing position to beach chair position during general~     anesthesia for shoulder arthroscopic surgery.~      Investigators hypothesized that by increasing arterial blood pressure with phenylephrine~     infusion, incidence of hypotension would be decreased.~   "
74975|NCT02585557|"~     The objective of this study is to determine if primary care practice support accelerates the~     dissemination and implementation of patient-centered outcome results (PCOR) findings to~     improve heart health and increases primary care practices' capacity to incorporate other PCOR~     findings in the future.~   "
74976|NCT02585544|"~     Day surgery is performed in the same way as in full hospital admission, allowing same-day~     discharge without increased risk. It provides many grounds for patient satisfaction. Progress~     in surgical and anesthesia techniques now allows this form of management to be developed and~     prioritized.~      Day-care surgery for prolapse has been little studied. The present study is intended to help~     extend its future implementation, the primary objective being to assess the feasibility of~     the day-care approach in prolapse surgery. The secondary objectives are to study criteria of~     non-eligibility for day-care prolapse surgery, reasons for patients' refusal, causes of~     failure, predictive factors for failure, patient satisfaction, postoperative complications,~     2-year anatomic and functional results, pain, quality of life and sexuality, and~     postoperative onset of dyspareunia and urinary incontinence.~      The design is for a prospective non-randomized study conducted in 3 gynecologic surgery sites~     managed by the Lyon hospitals board (Hospices Civils de Lyon).~   "
74977|NCT02585531|"~     Bronchiolitis is one of the main reasons for consultation in primary care and emergency~     services, as well as the leading cause of hospitalization for lower respiratory tract~     infection in children under two years. There is still no consensus on the medical management~     of the disease, in clinical practice there is wide variability in the treatment with inhaled~     drugs and / or oral bronchodilators, steroids, antihistamines despite the viral etiology of~     the disease, which results in increased morbidity and a major economic benefit for all health~     services.~      Several studies are in relation to the management of bronchiolitis, one of which was made~     during 2014 in the Naval Hospital of High Specialty which included 90 participants comparing~     3 treatment. The treatments administered were: dexamethasone and epinephrine (Levogira) (ED),~     hypertonic saline 3% (SSH 3%)and saline 0.9% ( SS 0.9%), finding that the handling of ED and~     SSH 3% had lower rates of hospital admissions compared to the symptomatic management of SS~     0.9%. Although the superiority of SSH3% and ED in relation to the use of SS 0.9% was~     demonstrated, it was not possible to establish difference statistically significant between~     them. Why it was considered necessary to continue the study focused on determining the~     difference in the effectiveness of ED and SSH 3%. Therefore, the purpose of this~     investigation is to determine whether there is a difference between the use of dexamethasone~     and epinephrine versus hypertonic saline (3%).~   "
74978|NCT02585518|"~     The current study seeks to elucidate the context of pathological and non-pathological eating~     behavior in a heterogeneous sample of overweight and obese children, aged 8-14 years.~     Children will undergo a two-week ecological momentary assessment (EMA) protocol in which they~     record all eating episodes and their physiological, emotional, interpersonal, and~     environmental correlates. Specific aims are to identify proximal antecedents and consequences~     of pathological and non-pathological eating in overweight and obese children, and to~     determine the prevalence of loss of control eating in the natural environment.~   "
74979|NCT02585505|"~     Stem cells have promising potential in treating diabetes. However the therapeutic outcome in~     diabetic patients will profoundly depend on their delivery to pancreas. Our objective is to~     label stem cells with PET tracer F18-FDG to carry out in vivo cell tracking. The labeled stem~     cells will be given through different routes (intravenous and intraarterial)and tissue~     distribution studied. Patients will be followed up for the next 6 months. Glucagon stimulated~     C peptide will be measured at baseline and at 6 months and HOMA IR and HOMA beta will be~     calculated.~   "
74980|NCT02585492|"~     The purpose of this study is to determine if the position of the mother in the first two~     hours after delivery, while she is in skin to skin contact with your child, influences the~     oxygen saturation and/or heart rate of the newborn. In this way it could provide some useful~     information for the prevention of seemingly lethal episodes or sudden death of the child~     when, following current recommendations is skin to skin contact in the first hours of life.~     These episodes are communicating in all developed countries and have caused great concern and~     interest in the scientific community. So far we only have information from case series.~   "
74981|NCT02585479|"~     The purpose of this study is to determine that systemic chemotherapy is superior to~     transcatheter arterial chemoembolization in prolonging progression-free survival（PFS） in~     patients with Advanced Hepatocellular Carcinoma.~   "
74982|NCT02585466|"~     Reports have been appearing in literature over the past years of various~     nociception-antinociception monitors, introduced and promoted from major manufactures.~     Recently a new term Practice misalignment has been recently coined indicating research study~     groups that are distant from daily anesthesia practice, with some scientific relevance but~     very little clinical relevance simulating purely hypothetical conditions that are not~     related to everyday anesthesia practice.~   "
74983|NCT02585453|"~     Dry eye syndrome is a highly prevalent ocular disease with an increasing incidence in the~     elderly population. Topically administered lubricants are the basis for treatment of this~     disease. However, exact information about the tear film thickness and the corneal residence~     time of topical lubricants is still sparse, therefore no ideal treatment regimen has been~     found.~      Recently a new method for assessment of tear film thickness based on ultra high resolution~     optical coherence tomography (OCT) has become available. The aim of the present study is to~     assess tear film thickness and corneal residence time of three different formulations of~     topical lubricants, in particular Thealoz Duo® Eye Drops, Hylo® Gel Eye Drops and Systane®~     Gel Eye Drops in patients with moderate to severe dry eye disease. In addition, standard~     tests for dry eye syndrome, such as the ocular surface disease index (OSDI©), Schirmer I test~     and determination of tear break up time (BUT) will be performed.~   "
74984|NCT02585440|"~     This is a phase 1 study to evaluate the safety and tolerability of multiple oral doses of~     CMX157 at increasing dose levels.~   "
74985|NCT02585427|"~     It is now recognized that diet plays a critical role in the etiology and management of the~     chronic diseases such as diabetes, obesity and cardiovascular disease. A high consumption of~     fat, especially saturated fat, is an established risk factor for Cardiovascular Disease.The~     glycaemic index (GI) is a measurement of the ability of different types of carbohydrate-based~     foods to raise blood glucose. The interest in low GI food as a weight management tool has~     been increasing. Different types of carbohydrates differ in their ability to increase~     postprandial blood glucose and insulin secretion, and may also modulate the effect of~     different fatty acids. The current study will compare the consumption of low and high GI~     carbohydrate with different fat saturation on postprandial glucose, insulin, and~     triacylglycerol responses in healthy participants.~      The data generated will have direct applications in public health policy and clinical~     nutrition management of chronic disease. The outcomes of the study will significantly~     contribute to the long term national goals of Singapore to manage and to reduce the incidence~     of chronic disease associated with the metabolic syndrome.~   "
74986|NCT02585414|"~     Dry eye syndrome (DES) is a highly prevalent ocular condition with potential severe~     consequences for affected patients. DES can be either caused by decreased tear production or~     increased tear evaporation, both leading to an instable tear film. Despite many efforts,~     generally accepted methodologies to diagnose, assess the severity and monitor DES are still~     lacking. Moreover, widely used clinical methods such as tear break up time (BUT), fluorescein~     staining of the cornea or Schirmer test only poorly reflect patients´ complains.~      One of the main problems in the diagnosis and treatment of DES is that the most critical~     component - the tear film itself - is difficult to characterize. The development of new~     ultra-high resolution optical coherence tomography systems allows now for the direct~     visualization of the human tear film and for the non-invasive in-vivo measurement of tear~     film thickness (TFT). The investigators could recently show that this system provides~     excellent reproducibility and is able to assess even subtle changes in TFT induced by~     therapeutic interventions. However, to which extent tear film thickness is associated with~     other standard clinical measures of DES is currently unknown. In the present study, the~     investigators set out to test the hypothesis that ocular TFT is a new and good surrogate~     parameter for the assessment of the severity of DES.~      Consequently, the aim of the study presented in this protocol is to investigate whether and~     if so, to what extent clinical signs of DES and reported symptoms are reflected in ocular~     TFT. For this purpose, a cross sectional study in healthy subjects and patients with DES will~     be performed. This should allow the investigators to more specifically characterize the role~     of the tear film in DES and to assess whether measurement of TFT with OCT can be a promising~     surrogate parameter for the diagnosis and the follow up of DES.~   "
74987|NCT02585401|"~     The primary objective of this study is to measure physician knowledge and understanding of~     the key safety information contained in the Eylea vial preparation instruction card, the~     intravitreal injection procedure video, and the product monograph.~   "
74988|NCT02585388|"~     The CHEOPS study aims to confirm the clinical benefit of a combination of an anti-aromatase~     and metronomic chemotherapy treatment~   "
75000|NCT02585232|"~     The purpose of this randomized controlled pilot study is to examine the preliminary~     effectiveness, feasibility, and potential treatment moderators (i.e., behavioral symptoms and~     spousal relationship status) of a newly developed intervention for individuals with dementia~     and their family caregivers that combines elements of the established care consultation (CC)~     approach with additional counseling modules (CC+C). Outcomes for Veterans with dementia and~     their family caregivers (e.g., depressive symptoms, care-related burden, quality of life,~     pleasant events, etc.) will be assessed after 6 months of treatment and again at 12 months.~   "
75131|NCT02583516|"~     The purpose of this study is to evaluate the efficacy and safety of two different schedules~     of administration of vemurafenib in combination with cobimetinib (continuous and~     intermittent) in previously untreated BRAFV600- mutation positive patients with unresectable~     locally advanced or metastatic melanoma.~   "
74989|NCT02585375|"~     Topical antihypertensive eye drops are a key element of modern antiglaucoma treatment. Most~     of these eye drops contain preservatives to allow for the use of multi-dose containers. In~     the recent years evidence has, however, accumulated that these preservatives may induce~     ocular surface disease (OSD). This is particularly true for the most widely used~     preservative, benzalkonium chloride (BAK). Whereas this is well documented in many in vitro~     and animal studies, evidence from clinical trials is sparse. The only randomized masked study~     that showed superiority is a pivotal company-sponsored study indicating improved tolerability~     and reduced hyperemia of unpreserved versus preserved latanoprost eye drops.~      The investigators have recently introduced an optical coherence tomography (OCT) technology~     that provides a resolution as high as 1.2 µm for the human cornea. Using this technology the~     investigators were able to show that tear film thickness (TFT) is negatively correlated with~     symptoms of OSD. Changes in TFT can be assessed with very high sensitivity below the level of~     resolution as also evident from studies after administration of lubricants.~      In the present study, the investigators hypothesize that switching glaucoma patients from~     preserved prostaglandin analogues to unpreserved latanoprost is associated with an increase~     in TFT as measured with OCT. As a control the investigators will use preserved latanoprost~     and the study hypothesis will be tested in a randomized, controlled, single-masked parallel~     group design. TFT is chosen as main outcome variable, standard measures for signs and~     symptoms of OSD are selected as secondary outcomes. The present study may provide valuable~     information on the superiority of unpreserved versus preserved therapy.~   "
74990|NCT02585362|"~     This study evaluates physical performance in cancer outpatients during a multimodal therapy.~     Half of the patients will receive physical exercise und nutrition program in combination with~     a specially formulated whey protein supplement, while the other half will receive standard~     care.~   "
74991|NCT02585349|"~     Stroke is a leading cause of disability, affecting about 34,000 to 41,000 individuals in the~     Netherlands of middle and old age every year. Due to the aging of the population, this figure~     will increase considerably over the next decades (Struijs et al., 2005). Twenty-five percent~     of stroke patients die within one month, making stroke a major risk factor for premature~     death in developed countries. According to the World Health Organization, stroke is the third~     leading cause of the burden of disease in middle and high-income countries (World Health~     Organization, 2008). It has a significant negative impact on quality of life of both the~     patients as well as their caregivers and significant others. Surviving stroke patients often~     struggle with its manifold and lifelong lasting consequences, with 35 percent of patients~     being functionally dependent one year after stroke (Wolfe, 2000) and cognitive and emotional~     changes which are found up to two years post-stroke (Rasquin, Lodder, & Verhey, 2005).~     Depression, apathy, and cognitive impairment are very prevalent and significantly contribute~     to the burden of the disease, but their etiologies remain poorly understood.~      The aim of the CASPER study is to gain more insight into the etiologies of post-stroke~     depression (PSD), post-stroke apathy (PSA), vascular cognitive impairment (VCI), and~     post-stroke dementia. Therefore, the primary objectives are to identify biomarker-based~     predictors of PSD, PSA, and VCI. A secondary aim is to study effect modulation, especially~     the interaction between cerebrovascular disease, neurodegenerative changes and inflammation~     in post-stroke dementia.~      CASPER is a prospective clinical cohort study of 250 first-ever ischemic stroke patients with~     serial assessments at baseline (10 to 12 weeks after stroke), six and 12 months after~     baseline. Another wave (36 month after baseline) was later added.~   "
74992|NCT02585336|"~     Sugar-sweetened beverages (SSBs) have been epidemiologically linked to serious health~     problems including heart disease, liver disease, and diabetes. This study will recruit~     frequent SSB drinkers who are employees at the University of California, San Francisco (UCSF)~     and measure markers of metabolic health on two occasions, 10 months apart. During this time,~     UCSF will cease selling SSBs at all campus and medical center locations. Additionally, at the~     first assessment half of participants will be randomly assigned to a brief intervention to~     help reduce SSB consumption, consisting of a 10-20 minute semi-structured interview designed~     to share health information about SSBs, elicit motivations to reduce consumption, and help~     set concrete plans to reduce consumption. The investigators will be able to compare changes~     in metabolic health among those who do and do not reduce SSB consumption. This will make a~     unique contribution to the growing evidence regarding both the effects of SSB consumption on~     health and the modifiability of SSB-related health conditions.~   "
74993|NCT02585323|"~     Physical activity is an essential first-line treatment for patients with knee osteoarthritis~     (OA). However, only 13% of patients meet the activity recommendation of 150 minutes or more~     per week. The primary goal of this randomized controlled trial is to assess the efficacy of a~     Fitbit Flex (a wireless physical activity tracking device) paired with a new application,~     plus a brief education session and telephone counselling by a physiotherapist (PT), to~     improve physical activity and reduce sedentary time in patients with knee osteoarthritis.~   "
74994|NCT02585310|"~     In Siriraj Hospital, blood consumption in Cardiac surgery is high (units per patient) and~     frequent (number of patients receiving blood). The incidence of side effects are unknown, as~     is the exact amount of blood used/provided for patients with elective CABGs.~      The primary objective of this study was to demonstrate the incidence of packed red blood cell~     (PRBC) transfusion in elective CABGs.~   "
74995|NCT02585297|"~     Study Goals:~        1. Finding the prevalence of bacteria of the sperm in an innovative and more accurate~          methode~        2. Understanding the effect of microbes on the process of capacitation~        3. The impact of microbes in the sperm on IVF success rate~        4. Finding the incidence of vaginal bacteria and their relationship to bacteria of the~          sperm~        5. The impact of vaginal flora on IVF success rate~   "
74996|NCT02585284|"~     Recently, reports appeared of an 88-yr-old octogenarian exhibiting bispectral index (BIS)~     value of 46 before anaesthesia induction, and a 91-yr-old nonagenarian fully conscious at BIS~     value of 52 after propofol anaesthesia recovery. BIS algorithm was heuristically derived from~     a database of mostly relatively fit, young healthy volunteers. To date there are no studies~     precisely quantifying BIS response to propofol concentrations among different age groups~   "
74997|NCT02585271|"~     The purpose of this study is to compare the clinical outcomes of transanal decompression tube~     as a bridge to surgery with stent as a bridge to surgery for acute malignant left-sided~     colonic and rectal obstruction.~   "
74998|NCT02585258|"~     Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in~     treatment strategies for elderly patients with rheumatoid arthritis:~      The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study (GLORIA)~   "
74999|NCT02585245|"~     This research study will compare two different screens for nutrition risk in patients who are~     in the hospital. We will be comparing the ThedaCare Nutrition Risk Screen to see if it is as~     good and consistent as the standard NRS 2002 Nutrition Risk Screen.~   "
75001|NCT02585219|"~     The tracer 11C-methionine (11 C-MET) is used as a specific cell proliferation tracer which~     shows metabolically active tumordeposities. A healthy brain barely takes up 11C-MET, causing~     the difference between the background and the tumor to be realively high. In addition, there~     is relatively little 11C-MET uptake in inflammatory processes. This makes 11C-MET a very~     suitable positron emission tomography (PET) tracer in order to differentiate between tumor~     progression and therapy changes. The latter is a major clinical problem for which further~     investigation is necessary.~      In order to be able to make this differentiation, a direct post-operative baseline scan is~     required. With regard to the advanced MRI sequences, it is known that it is necessary to~     produce the post-operative baseline scan within 48 hours. After that timeframe, operation~     induced changes start to occur, such as granulation tissue. In that case the interpretation~     of the scan is no longer possible. Immediately postoperatively (<48 hours) 11C-MET has never~     been used before. Therefore, it is unknown whether 11C-MET provides a good baseline scan~     directly after surgery. This pilot will investigate the feasibility of this 11C-MET baseline~     scan and comparison the results with the advanced MRI sequences.~   "
75002|NCT02585206|"~     This study is comprised of 2 phases to study the impact of a text message system on overall~     adherence to a web-based smoking cessation program. Phase I uses a full factorial design to~     identify the most optimal text message intervention to maximize adherence to the~     BecomeAnEX.org smoking cessation program. Phase II is a randomized controlled trial that~     compares regular BecomeAnEX users to those who will receive the optimized text message~     intervention (from Phase I) in conjunction with BecomeAnEX for impact on long-term~     abstinence.~   "
75003|NCT02585193|"~     While some evidence on weight change elicited from commercially available weight loss~     programs, such as Weight Watchers, is available, there is little evidence evaluating any~     health-related outcomes that result from losing weight through these programs. In addition,~     little data exists on the adherence and satisfaction of these types of programs. The purpose~     of this study is to evaluate body weight and health-related outcomes that are achieved from~     participating in a Weight Watchers program, along with program adherence and satisfaction.~     Men and women (N=150) that are participating in Weight Watchers weight loss program will~     undergo assessments at the University of Pittsburgh to evaluate outcomes related to the~     Weight Watchers 6 month intervention. Assessment visits, separate from the intervention, will~     take place at baseline (0 months), 3 months and 6 months for approximately 90 minutes at the~     Physical Activity and Weight Management Research Center. Participants will be asked to~     undergo assessments of body weight, height, aerobic stamina, functional fitness, flexibility,~     and complete a series of questionnaires related to demographics, program satisfaction, sleep~     quality, happiness, and food cravings. Adherence to the program will be measured by the~     number of group sessions attended.~   "
75004|NCT02585180|"~     Many studies provide evidence for the benefit of lower respiratory tract surveillance, mostly~     by culture of endotracheal secretions, to predict bacterial pathogens (especially multi-drugs~     resistant pathogens) involved in VAP. The DEMETER study (NCT02515617) assessing the~     medico-economical impact of the subglottic secretions drainage (SSD) provides the opportunity~     to evaluate the accuracy of the subglottic secretions culture surveillance to predict~     pathogens involved in VAP (in comparison with the concomitant endotracheal secretions~     surveillance). These subglottic and tracheal secretions culture surveillance will be masked~     to the investigators of the DEMETER Study.~      This ancillary study will be performed in 14 centers participating to the DEMETER study~   "
75005|NCT02585167|"~     This is a randomised controlled trial to evaluate the outcome of treatment of complex~     perianal fistula by Video-assisted anal fistula treatment (VAAFT) compared to fistulectomy~     and sphincter reconstruction as standard surgical procedure.~   "
75006|NCT02585154|"~     Parkinson's disease (PD) is a common, disabling, progressive condition characterised by~     severe problems with movement for which medical treatment in the longer term can be~     unsatisfactory. Deep brain stimulation (DBS) is a treatment, which directly stimulates the~     nerve cells affected inside the brain to help overcome the difficulties with movement.~     Classically, DBS stimulates in a manner that is constant and independent of a patients~     underlying condition as reflected in their brainwave activity. Recent research has suggested~     that adjusting DBS in real time using analyses of brain signals recorded from DBS electrodes~     (termed closed loop DBS) nay be better than classical DBS in alleviating difficulties with~     movement. However, it remains unclear whether closed-loop DBS also leads to fewer unwanted~     side effects on movement control.In order to answer this question, the investigators will~     analyze DBS activity and activity recorded from the surface of the head in PD patients~     undergoing DBS surgery. During the recordings patients will perform different movement tasks.~     DBS has been found to reduce patients' ability to suppress inappropriate movements in certain~     tasks and performance in these tasks will be the core point of interest. The recordings will~     be conducted three times: During closed loop DBS, classical DBS and while the stimulator is~     turned off. This will allow the investigators to assess putative differences in the effect of~     closed loop and classical DBS with regards to wanted and unwanted effects on movement control~     and to elucidate their correlates in the brain.~   "
75007|NCT02585141|"~     The purpose of this study is to compare aspiration and oral antibiotics with surgical~     incision in the treatment of perianal abscesses in terms of recurrence and subsequent fistula~     formation. Included patients will be randomised to either aspiration or incision.~   "
75008|NCT02585128|"~     Patients undergoing transcatheter aortic valve implantation (TAVI) have distinctive~     characteristics: they are old, frail, with several co-morbidities and take multiple~     medications. Hemodynamic instability, cerebral embolism, sedation, general anesthesia and~     hospitalization in intensive care expose those patients to postprocedural delirium.~      Acute neurocognitive dysfunctions are associated with adverse outcomes in these population.~      The objective of this study is to determine the incidence of delirium and neurocognitive~     disorders in elderly patients after TAVI.~   "
75009|NCT02585115|"~     The aim of this study is to determine if sampling technique of urine affects diagnostic~     modalities in primary care. Furthermore it aims to determine if there is difference in the~     accuracy of the point-of-care test, when the urine sample is stored at room-temperature and~     analyzed later in the day.~   "
75010|NCT02585102|"~     The purpose of this study is to see if perceived barriers to vegetable consumption can be~     overcome by making it easier for people eat more vegetables and to see if the effects last~     over time.~   "
75011|NCT02585089|"~     Spanish dry-cured ham has been shown a source of antihypertensive peptides in mice. To date,~     no clinical study has been performed in humans to check the effects of bioactive peptides~     produced naturally during the processing of pork dry-cured ham on blood pressure. Therefore,~     the aim of the present study is to investigate whether consuming peptides from cured pork ham~     with demonstrated angiotensin I-converting enzyme (ACE) inhibitory activity lowers blood~     pressure (BP) and improves other risk factors for cardiovascular disease (CVD).~      Objectives: To demonstrate the lowering effects of bioactive peptides from cured pork ham~     with >10 months dry-curing process in humans. To check for other possible benefits related to~     dry-cured ham intake such as: platelet activation and cardiovascular risk factors.~   "
75012|NCT02585076|"~     Arterial hypertension has been recognized as a major causal factor for atrial fibrillation~     (AF), the most common sustained cardiac arrhythmia. In light of its worldwide increasing~     prevalence and incidence and the accompanied increase in the risk of stroke, thromboembolic~     events and mortality, AF has emerged as a global healthcare problem.~      Early diagnosis of AF, prior to the occurrence of complications is a recognized priority for~     the prevention of strokes. Once diagnosed, anticoagulant therapy is the cornerstone in the~     management of the risk of stroke in AF patients. The 2012 ESC Guidelines recommend the use of~     a risk factor-based approach to stroke risk stratification for AF patients.~      This study aims towards gaining real-world data on the prevalence of non-valvular atrial~     fibrillation (NVAF) among hypertensives in Greece. The rate of ESC guideline-adherent~     antithrombotic therapy on the basis of stroke and bleeding risk assessments, and factors~     influencing treatment decision-making will be assessed as well in patients diagnosed with the~     arrhythmia.~      Finally, potential differences in the NVAF prevalence in adequately and inadequately~     controlled hypertensives will be documented.~   "
75013|NCT02585063|"~     The UK government's Crown report titled 'Review of prescribing, supply & administration of~     medicines' enabled optometrists to train for the qualification of independent prescribing~     (IP). The UK introduced IP for optometrists in 2009. The proposed research focuses on the~     role of IP optometrist in the acute ophthalmic services of Manchester Royal Eye Hospital~     (MREH). The study will compare IP optometrists to consultant ophthalmologists in the ability~     to diagnose, manage and prescribe medication for patients accessing these services.~      To achieve this comparison consenting participants will first have a clinical assessment with~     the IP Optometrist, where findings including diagnosis and management plan will be recorded~     onto a research proforma. The consultant ophthalmologist will be masked to the IP~     Optometrist's research proforma to prevent bias. The consultant ophthalmologist will then~     perform a clinical assessment on a second proforma and inform the participant of their~     diagnosis and management plan. Percentage agreement, kappa (κ) and weighted κ will be~     calculated for a range of parameters between the two proformas. Disagreement in diagnosis or~     management will be arbitrated by a separate ophthalmologist participating in the study with a~     specialty relevant to the participant's condition.~      The main objective of the research is to expand the limited base of evidence of of IP~     optometrists' ability to diagnose, manage and prescribe medication and to determine whether~     they work at least as safely and effectively as consultant ophthalmologists in acute~     ophthalmic services. It is the first study in this area since the advent of IP for~     optometrists, with only one previous study published before IP was introduced. The research~     will enable the type and frequency of conditions presenting in these services to be measured.~     Furthermore it will identify conditions that IP optometrists can manage independently and~     enable guidelines for these conditions to be developed.~   "
75014|NCT02585050|"~     Debates about the official and legal implementation of Do not attempt resuscitation (DNAR)~     orders are ongoing. The aim of this study was to determinate factors that influence~     neurological outcomes at discharge and the ratio of living patients discharged from the~     hospital due to DNAR prohibition.~   "
75015|NCT02585037|"~     The Kinesio Taping® method, therapeutic bandage, is another feature can be used in physical~     therapy, aiming to muscle enhancement, weakened muscles correction, analgesia, among others,~     by cutaneous stimulation of mechanoreceptors. This study aims to evaluate the efficiency of~     the use and effects offered by Kinesio Taping® method, changes in muscle strength of grip in~     normal subjects for clinical application.~   "
75016|NCT02585024|"~     A number of pharmacotherapies are available for smoking cessation in New Zealand including~     nicotine replacement therapy, bupropion, an antidepressant medication and varenicline. Of~     these, varenicline is the most effective, but also the most expensive. Varenicline acts like~     nicotine and stimulates nicotine receptors in the brain, but to a lesser extent, and~     simultaneously block nicotine binding to its receptors and thus reduces the rewarding effects~     of cigarette smoking. Cytisine (Tabex® and Desmoxan®) is a plant alkaloid and also acts in a~     similar way to varenicline but is significantly cheaper. It has been used for more than 50~     years in some parts of eastern and central Europe as an aid to quit smoking, but is not~     approved for use in many countries such as New Zealand, Australia, the UK or the US.~     Randomised, placebo-controlled trials have shown that cytisine is more effective than placebo~     and nicotine replacement therapy (NRT)for smoking cessation. However there is a paucity of~     pre-clinical data on cytisine. In particular, there are limited data on the pharmacokinetic~     and the dose response characteristics of cytisine. Furthermore, the current dosing regimen~     recommended by the manufacturer is complex and has no clear basis in empirical research.~      Complexity of dosing has been shown to be a key factor in determining adherence. Therefore, a~     simpler regimen would likely maximise the effectiveness of treatment through improved~     adherence to the treatment regimen. The investigators therefore propose to undertake two~     studies to investigate the influence of dose, dosing frequency and dosing duration on the~     pharmacokinetics and tolerability of cytisine and cigarette craving in smokers.~   "
75017|NCT02585011|"~     At St.Olavs Hospital each year about 400 patients are treated for femoral neck fractures, 250~     of them receiving hemiarthroplasty. Implementation of fast-track clinical pathways reduces~     morbidity and enhances recovery of patients undergoing hemiarthroplasty. One of the key~     prerequisites for early rehabilitation is optimized pain relief. Local infiltration~     anesthesia with Ropivacaine is part of a multimodal pain regimen for patients receiving~     hemiarthroplasty at St.Olavs Hospital, although the pain reducing effect of local Ropivacaine~     after hemiarthroplasty has not been investigated in clinical trials. In this study it will be~     investigated whether a single shot with Ropivacaine reduces acute postoperative pain and~     opioid requirement after hemiarthroplasty. The findings of this study will have a direct~     impact on patient treatment.~   "
75018|NCT02584998|"~     The main study aim is to develop, implement and disseminate a pilot population-based mailed~     FIT outreach screening program in the Philadelphia VA Medical Center that does not rely on~     having an office visit, by conducting a proof-of-concept 3-arm parallel-design pragmatic~     randomized trial to (1) Compare the effects of usual care (UC), screening invitation +~     reminder (invitation-reminder), or screening invitation + mailed FIT kit + reminder~     (mailed-FIT); (2) Explore whether the FIT completion rate varies by age or race/ethnicity;~     and (3) Explore barriers to use of mailed outreach screening for Veterans.~   "
75019|NCT02584985|"~     Standard surgical treatment of mid and low rectal cancer is total mesorectal excision (TME).~     Originally performed by open surgery, TME demonstrated improved local control and reduced~     urogenital morbidity. Laparoscopic approach has been validated by several randomised~     controlled trials: laparoscopic approach offers to the patient a better post-operative~     recovery, a lower risk of wound hernia and comparable oncological results. However, the risk~     of conversion to open procedure remains significant.~      Endoscopic Transanal Proctectomy allows retrograd mesorectal excision, performing the whole~     pelvic dissection via a specific-moderate cost device. The procedure is then completed by a~     briefer transabdominal laparoscopic step to mobilise the colon and perform inferior~     mesenteric vessels ligation, prior to low coloanal anastomosis. The originality of this~     approach is to perform a surgical dissection via an extra peritoneal route, without~     peritoneal and abdominal wound trauma. This focuses on new technical improvement in the area~     of mini-invasive pelviabdominal surgery using natural orifice as surgical access. This~     approach offer closer and better exposure of pelvic dissection plane and could improve~     oncological quality and pelvic nerve preservation. It could be profitable to postoperative~     patient outcome. However rates and type of cancer-recurrences as well as functional results~     have to be assessed in a controlled study. This technique has shown to be feasible and~     reproducible through early clinical series. Conversion rates appear to be lower than~     published rates of laparoscopic approach, markedly inferior to 10%. Compiled rates of~     morbidity (27.8%), R1 resection* (6%), mesorectum macroscopic integrity (100%) appear to be~     comparable to laparoscopic approach results. However functional results as well as urologic~     morbidity have to be evaluated in comparative studies. In a preliminary retrospective~     comparative (n=72) we founded comparable oncological quality criteria (R1 resection 5.9% vs~     10.5% p 0.74, Grade 3 mesorectal integrity 57.5 vs 56.2 p 0.99), lower conversion rate to~     open procedure (2.9% vs 23.6% p 0.011), shorter in-hospital stay (8 vs 9 days p 0.038).~     Comparable morbidity rates (Dindo 1-4 27% vs 34% p 0.52) and functional results (Kirwan 1/2~     80.3% vs 80.6% p 0.94) were also founded. These data need to be confirmed. To this date,~     Endoscopic Transanal Proctectomy has been evaluated through preliminary studies including~     several short series demonstrating the feasibility of the technique and showing low~     morbidity. For some authors the benefit of transanal approach is significant in difficult~     cases such as male patient and narrow pelvis. Very recently, two non randomised comparative~     studies were published with conclusions close to those in our study.~      Investigators propose, with the support of the GRECCAR group, to conduct a national,~     multicenter, open-label randomized study based on oncological non-inferiority (R1 resection~     rate) for the main objective, comparing Endoscopic Transanal Proctectomy to Standard~     Transabdominal Laparoscopic Proctectomy, for low lying rectal cancer requiring manual~     colo-anal anastomosis. There is a clear expected benefit expected for the patients through~     the ETAP procedure in term of post operative short term outcome, risk of conversion to open~     procedure, risk of wound hernia.This trial could also show significant advantages in terms of~     quality of dissection, quality of the specimen, quality of nerve preservation.~   "
75020|NCT02584972|"~     Lately, many researchers have found that Children with autism spectrum disorder (ASD) are~     most likely to have gross motor deficiencies such as lack of coordination in gait and~     balance. Much has been researched on etiology and motor learning, but only very few~     researches have examined and analyzed quantitatively gait and balance in ASD. The aim of this~     research is to analyze quantitatively balance, gait and balance during perturbation in~     children with ASD and to compare with typically developed children (TD). A group of 20~     children diagnosed with ASD and a control group of 20 TD children will be recruited and~     tested in the laboratory with well-established measures of gait and balance function. They~     will be instructed to stand as still as possible on a force plate with different task~     conditions : (1) standing with the eyes open (EO) - standing upright viewing an X displayed~     on a screen 3 meters in front of them; (2) eyes closed (EC) - same as (1) with the eyes~     closed and covered by blindfolds (i.e. no visual information). (3) Same as 1 standing on foam~     (i.e., conflicting proprioceptive information). Gait will be measured using the narrow base~     walk test, modified for clinical use. Participants will be asked to walk within a narrow path~     6 meters long . The statistical analysis will include Independent T-tests to compare the ASD~     and controls with respect to different characteristics. General Linear Model (GLM) will be~     used by applying a separate model where the dependent variables will be the average values of~     the postural stability or gait stability parameters (continuous) and the independent~     variables were categorical by the group and task condition.~   "
75021|NCT02584959|"~     The purpose of this study is to assess the efficacy and safety of subcutaneous administration~     of a liquid formulation of C1 esterase inhibitor for the prevention of angioedema attacks in~     adolescent and adult subjects with hereditary angioedema.~   "
75022|NCT02584946|"~     The aim of the proposed study is to examine whether long-term dietary supplementation (8~     weeks) of an oat flour cookie rich in avenanthramides (AVA) could enhance blood antioxidant~     capacity and reduce blood inflammatory markers after a downhill running (DR) protocol among~     human subjects.~   "
75023|NCT02584933|"~     The rollover study will provide ceritinib to patients who are currently receiving treatment~     with ceritinib within a Novartis-sponsored study and in the opinion of the investigator,~     would benefit from continued treatment with ceritinib.~   "
75024|NCT02584920|"~     Randomised, double-blind, parallel group study to compare PK and PD profiles between HLX01~     and rituximab (MabThera®) in patients with CD20+ B-cell Lymphoma.~   "
75025|NCT02584907|"~     In this randomized, double-blind clinical trial, eligible hospitalized ICU patients with EN~     will be included. Patients will be divided into two groups. The control group with the~     standard EN and intervention group with high fat EN. 50% of the total fat will be provided by~     olive oil. Nutritional intake record form will be completed and daily calorie intake will be~     calculated. High fat EN feeding will be offered for 15 consecutive days maximally. At the end~     of the study mean blood glucose, duration of hospitalization and rate of infection will be~     compared in two groups.~   "
75026|NCT02584894|"~     The aim of this study is to assess the efficacy in PTSD treatment of concomitant voluntary~     reactivation of personal traumatic memories with neuromodulation of the right dorsolateral~     prefrontal cortex using 10Hz rTMS, compared to 1Hz rTMS, during 2 weeks.~   "
75027|NCT02584881|"~     Using a quasi-experimental design the investigators will compare the effect of adopting and~     implementing a Safe Opioid Prescription Practice (SOPP) protocol within a Level 1 trauma~     service team compared to a Level 1 trauma service team implementing standard care.~   "
75028|NCT02584868|"~     This study will compare the clinical efficacy and safety of Volulyte® and Voluven® during~     elective open-heart surgery in pediatric patients.~   "
75029|NCT02584855|"~     The main purpose of this study is to evaluate the safety and long-term efficacy of ixekizumab~     compared to placebo in participants with active psoriatic arthritis.~   "
75030|NCT02584842|"~     The purpose of this study is to determine retrospectively if the application of rivaroxaban~     after endovenous laser ablation with and without miniphlebectomy is safe and if it lowers the~     risk of venous thrombosis.~   "
75031|NCT02584829|"~     This phase I/II trial studies the side effects and how well localized radiation therapy or~     recombinant interferon beta and avelumab with or without cellular adoptive immunotherapy~     works in treating patients with Merkel cell carcinoma that has spread to other parts of the~     body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.~     Interferon beta is a substance that can improve the body's natural response and may interfere~     with the growth of tumor cells. Monoclonal antibodies, such as avelumab, may help T~     lymphocytes kill tumor cells. For cellular adoptive immunotherapy, specific white blood cells~     are collected from the patient's blood and treated in the laboratory to recognize Merkel cell~     carcinoma. Infusing these cells back into the patient may help the body build an effective~     immune response to kill Merkel cell carcinoma. Giving localized radiation therapy or~     recombinant interferon beta and avelumab with or without cellular adoptive immunotherapy may~     be a better treatment for Merkel cell carcinoma.~   "
75032|NCT02584816|"~     This is a Phase 3, open-label, randomized study to evaluate lot-to-lot consistency in the~     manufacture of Bovine Rotavirus Pentavalent Vaccine (BRV-PV).~   "
75033|NCT02584803|"~     This study is to assess the feasibility of 2 different ultrasound views of the inferior vena~     cava (IVC), a large vein that returns blood to the heart. Ultrasound is safe in pregnancy~     and, is regularly used to evaluate the fetus. It is hoped that imaging of the IVC will then~     allow us to determine the fluid status of the parturient which could be helpful in treating~     hemodynamic instability. This study will not involve any change in management of the~     participating patients.~   "
75034|NCT02584790|"~     NBI has been proven to be a useful tool to detect early NPC, but they were few studies~     concerning the detection of post-radiotherapy mucosal residual NPC using NBI system~   "
75035|NCT02584777|"~     To evaluate the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of~     pacritinib in Asian subjects with myelofibrosis (MF), which includes primary MF (PMF),~     post-polycythemia vera MF (PPV-MF) or post-essential thrombocythemia MF (PET-MF).~   "
75090|NCT02584062|"~     The purpose of this study is to observe the technologic application of no-touch fluid-air~     exchange in Surgery of Idiopathic Macula Hole.~   "
75036|NCT02584764|"~     The primary aim is to develop, and test the feasibility and efficacy of, a manual based,~     cognitive behaviour therapy (CBT) treatment for Hoarding Disorder (HD) delivered in a group~     format combined with an Internet support system. The investigators' secondary aim is to~     investigate the neurocognitive profile of the participants before and after treatment in~     order to explore if the treatment might have an impact on neurocognitive functioning and if~     certain neurocognitive profiles predict outcome.~      For the primary aim, the investigators hypothesize that the treatment will be acceptable to~     participants and decrease symptoms of hoarding. Regarding the secondary aim, the~     investigators hypothesize that deficiencies in executive functioning, as measured with a~     neurocognitive battery, will reduce upon completion of treatment and that baseline executive~     function will be associated with treatment outcome.~   "
75037|NCT02584751|"~     Respiratory dysfunction, esophageal dysmotility, and a gastroesophageal reflux disease (GERD)~     have been demonstrated to be highly prevalent in persons with SCI. GERD has been linked to~     respiratory symptoms and conditions such as asthma, chronic cough, and an increased rate of~     respiratory infections in the general population. In persons with asthma, respiratory~     symptoms and dependency on asthma medications have been reduced by treatment with anti-reflux~     medication. Possible mechanisms have been proposed for this link, including the~     microaspiration of reflux materials, which may result in airway acidification and aspiration~     pneumonia, or the stimulation of the vagus nerve through acid-sensitive receptors in the~     esophagus with associated esophageal inflammation and reflex bronchoconstriction.~     Investigators propose to study the effects of anti-reflux therapy (proton pump inhibition) in~     persons with SCI on objective and subjective symptoms of respiratory function to determine~     the underlying mechanisms of airway inflammation due to GERD.~   "
75038|NCT02584738|"~     The purpose of this study is to investigate the effectiveness of nebulized magnesium sulfate~     in patient with moderate to severe asthma exacerbation in pediatric emergency~   "
75039|NCT02584725|"~     The purpose of this study is to determine the effect of increasing doses of tranexamic acid~     (TXA) on limiting blood loss during total knee and total hip arthroplasty as defined by a~     change in hemoglobin from pre-operative baseline to the first post-operative day.~   "
75040|NCT02584712|"~     The aim of this study is to evaluate the effect of exercise training in the autonomic nervous~     system activity in breast cancer patients, who underwent doxorubicin medication.~   "
75041|NCT02584699|"~     This study aims to prospectively investigate the efficacy, toxicity and quality of life (QOF)~     of stereotactic ablative radiotherapy (SABR) using a moderate fractionation of 72 Gy/6 Gy/12~     F (BED10 = 115 Gy) in a single arm of elderly ( ≥ 70) patients with stage I (2009 UICC)~     non-small cell lung cancer (NSCLC).~   "
75042|NCT02584686|"~     Evidence has been arising that Botulinum toxin injections can relax smooth muscles fibers in~     the treatment of obesity and hyperactive bladder. Would a similar effect on cavernosal smooth~     muscles help in the treatment of resistant erectile dysfunction not responding to medical and~     injection therapy, thus avoiding surgical treatment options.~      The treatment group will be injected intracavernously with 50 units of BTX-A. The control~     group, 12 patients, will be injected with a normal saline injection.~   "
75043|NCT02584673|"~     The objective of this research is to verify the procedural improvements enabled by use of a~     CAIG system to supplement existing ultrasound guided, needle-based procedures. The primary~     focus will be procedures performed by the Anesthesia department.~   "
75044|NCT02584660|"~     The purpose of the study is to evaluate that low risk Pulmonary Embolism (PE) participants~     who are discharged from the Emergency Department (ED) to the home environment and treated~     with rivaroxaban as outpatients have fewer total days in the hospital for bleeding and/or~     venous thromboembolism (VTE) events through Day 30 compared to participants who are treated~     with initial hospitalization and standard-of-care.~   "
75045|NCT02584647|"~     The purpose of this study is to determine if treatment with PLX3397 and Sirolimus will be~     tolerated and result in shrinking of the cancer or stopping the cancer from growing. In the~     phase I portion, the maximum tolerate dose of the study drug will be determined. In the Phase~     II portion, progression free survival will be assessed at the dose level found in Phase I.~     Participants will continue to take the study drug until they experience an unacceptable side~     effect or their disease progresses. Funding Source - FDA OOPD~   "
75046|NCT02584634|"~     The purpose of this study is to evaluate the safety and efficacy of avelumab when combined~     with either crizotinib or PF-06463922.~   "
75047|NCT02584621|"~     The proposed study is a randomized controlled trial that compares the effectiveness of an~     electronic personalized health screening app incorporating motivational feedback (i.e. Check~     Yourself) to usual care among moderate to high risk alcohol users. The purpose of this study~     is to determine whether Check Yourself is more effective than usual care in reducing alcohol~     consumption and binge drinking and improving quality of care among adolescents receiving~     school-based health clinic services.~   "
75048|NCT02584608|"~     This study is an open label use of ACTIMMUNE for patients with Autosomal Dominant~     Osteopetrosis Type 2(ADO2). Effects of treatment will be evaluated after 14 weeks on~     ACTIMMUNE by bone resorption markers. This study will treat 12 patients with ADO2 recruited~     from Indiana University and Riley Hospital for Children at Indiana University Health.~   "
75049|NCT02584595|"~     The intent of this observational study is to understand the role of non-invasive programmed~     stimulation (NIPS) to induce substrate based MMVT in patients receiving new St. Jude Medical~     ICD or CRT-D systems.~   "
75050|NCT02584582|"~     Aim: To investigate the glucagonostatic effect of glucagon-like peptide-1 (GLP-1) independent~     of the gastric emptying rate.~   "
75051|NCT02584569|"~     This phase 1 study will be conducted to examine the degree and duration of brain PDE2A enzyme~     occupancy /target engagement as a function of TAK-915 plasma concentration in order to guide~     dosing and schedule for future clinical studies in schizophrenia with TAK-915.~   "
75052|NCT02584556|"~     The purpose of this study is to determine that adjuvant systemic chemotherapy is superior to~     adjuvant transcatheter arterial chemoembolization(TACE) in prolonging recurrence free~     survival（RFS） in patients after radical resection of hepatocellular carcinoma.~   "
75174|NCT02582957|"~     A randomized, concurrent controlled trial to assess if adding sigh breaths to usual invasive~     mechanical ventilation of victims of trauma who are at risk of developing ARDS will decrease~     the number of days they require invasive mechanical ventilation.~   "
75053|NCT02584543|"~     This is a open label, randomized phase VI study, to assess the safety and immunogenicity of~     co-administration of Hepatitis E vaccine with Hepatitis B vaccine. The concomitant group (n~     =300) received Hepatitis B vaccine concomitantly with Hepatitis E vaccine at day 1 and months~     1 and 6; The nonconcomitant group (n =150) received Hepatitis E vaccine at at day 1 and~     months 1 and 6. Another nonconcomitant group (n=150) received Hepatitis B vaccine at at day 1~     and months 1 and 6.~      Anti-HEV IgG and HBsAb were determined. Injection-site and systemic adverse events (AEs) were~     monitored for 30 days after any vaccination; serious AEs were monitored throughout the study.~   "
75054|NCT02584530|"~     This is a randomized controlled study comparing US guided vs standard procedure for PICC line~     placement in newborns admitted to Children's Hospital of Eastern Ontario Neonatal Intensive~     Care Unit who require a PICC line. Patients will be randomized using REDCap randomization~     module (stratified by gestational age < 28 weeks and >= 28 weeks and blocked to ensure~     approximate balance with each stratum) into two arms. - Arm 1: PICC line insertion procedure~     using anatomical landmarks and tip placement will be confirmed by X-ray (current standard);~     Arm 2: US guided PICC line insertion procedure and tip placement confirmation by both US and~     X-ray. Sample size of 33 infants per group would achieve greater than 80% power to detect a~     difference between groups.~      Primary outcome: Time to complete the standard versus the US-guided procedure.~      Secondary outcomes (comparison between two arms):~      The number of total venipuncture attempts needed to place a PICC line Number of tip~     manipulations after complete insertion Proportion of successful tip placement~   "
75055|NCT02584517|"~     Giant Cell Arteritis (GCA) is the most common vasculitis and has significant morbidity in~     terms of blindness, stroke, and tissue necrosis. It requires protracted treatment with~     high-dose steroids, and despite this there is a risk of flare during the treatment. Little is~     known about the initial triggers for the inflammatory process, and there are no good markers~     of response or relapse. We will study patients referred with suspected GCA to identify~     important components of the immune response in GCA, and follow them over time to collect~     evidence of how best to monitor their condition.~   "
75056|NCT02584504|"~     Primary Objective:~      To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab~     administration as add-on therapy to non-statin lipid modifying therapy (LMT) including diet~     therapy alone or the lowest strength of statin in comparison with placebo after 12 weeks of~     treatment in participants with hypercholesterolemia.~      Secondary Objective:~        -  To evaluate the effect of two treatment regimens of alirocumab on other lipid~          parameters: apolipoprotein B (Apo-B), non-high-density lipoprotein cholesterol (non~          HDL-C), total cholesterol (TC), lipoprotein (a) [Lp(a)], high-density lipoprotein~          cholesterol (HDL-C), triglyceride (TG), and apolipoprotein A-1 (Apo A-1).~        -  To evaluate the safety and tolerability of alirocumab administration.~        -  To evaluate the development of anti-alirocumab antibodies.~        -  To evaluate the pharmacokinetic and pharmacodynamic profiles of alirocumab~          administration.~        -  To evaluate the long-term safety in participants receiving open-label alirocumab~          administration.~   "
75057|NCT02584491|"~     The purpose of this study is to determine the associations between changes in neural activity~     and structure, advanced gross motor skills, gait characteristics, and physical activity~     participation following a gait-related intervention that is based on motor learning~     principles for ambulatory children and youth with hemiplegic and diplegic cerebral palsy. The~     investigators' hypothesis is that in conjunction with a program of motor learning based~     training, functional neuroplastic changes in the involved motor areas will be strongly~     associated with changes in gait and advanced gross motor skills, moderately associated with~     physical activity based participation changes, and will have a fair association with~     structural neuroplastic change.~   "
75058|NCT02584478|"~     This trial is a Phase 1b/2a trial designed to evaluate the safety and efficacy of adding oral~     AL3818 to standard platinum-based chemotherapy concurrently and continued as a maintenance~     therapy for up to 12 months.~   "
75059|NCT02584465|"~     The objective of this randomized phase II is to evaluate the benefit of regorafenib for~     ovarian patients who reported a confirmed elevated CA-125 level under surveillance or~     bevacizumab, compared with tamoxifen.~   "
75060|NCT02584452|"~     Despite the apparent multifaceted benefit in differentiating blockade sites and duration of~     nerve blockade, the efficacy of continuous adductor canal blockade utilized specifically in~     ACL reconstruction has not been extensively studied. This study will test the hypothesis that~     the use of the adductor canal continuous nerve catheter will result in lower subjective pain~     scores on postoperative day 2 and improved quadriceps strength on postoperative day 1.~   "
75061|NCT02584439|"~     The conduit arteries exhibit a viscoelastic behavior. Visco-elasticity is partially regulated~     by endothelium and contributes to the optimization of the heart-vessel coupling. Aging or~     high resting heart rate (HR) could alter visco-elastic properties leading to increase~     stiffness of the conduit arteries, an independent cardiovascular risk factor, and degradation~     of heart-vessel coupling. Lowering HR with ivabradine could reduce these effects.~      The objective of this study is to assess the effect of HR reduction by repeated~     administration of ivabradine on visco-elastic properties, vascular geometry and function of~     common carotid artery, and on cardiovascular hemodynamic in healthy subject. The influence of~     aging on ivabradine effects are studied too.~      30 healthy volunteers aged between 25 and 65 years old, with a HR ≥ 70 bpm, will receive~     ivabradine or placebo during 8 days in a single center, randomized, cross-group, double~     blinded, placebo-controlled study. Each period of treatment will be separate by 12 to 16 days~     of wash-out. Each subject will participate in an exploration visit, including evaluation of~     visco-elastic properties, vascular geometry and function of common carotid artery, and~     cardiovascular hemodynamic, before and after ivabradine or placebo taking.~   "
75091|NCT02584049|"~     The purpose of this study is to evaluate effects of Osteopathic Treatment in the Management~     of Care-induced pain in Elderly care, in Follow-up care and Rehabilitation Geriatric.~      The investigators assume that the application of a procedure based on osteopathic fascial~     techniques in elderly care in Suite and Geriatric Rehabilitation ( SSRG ) suffering from pain~     of nursing care, could reduce the painful phenomenon having systemic action, and improve~     tissue engineering, trophicity viscera and the neurovascular supply .~   "
75062|NCT02584426|"~     Pressure ulcers (PU) are skin breakdowns that often form after blood flow in the skin is~     reduced from prolonged and repeated exposure to externally applied forces. As many as 85% of~     individuals with a spinal cord injury (SCI) report the occurrence of at least 1 PU since~     being injured. Despite the increasing attention and emphasis on prevention, PUs still~     represent a major health risk for persons with SCI. PUs and other skin breakdowns are at risk~     for becoming infected; it is not uncommon for many different types of bugs to be found in~     the wound. It has been assumed that the presence of these organisms did not impede wound~     healing or skin graft survival. The current proposal will use a new type of procedure that~     involves the direct injection of an antibiotic (in saline) into the skin beneath the wound;~     it is then distributed throughout the wound using a second device that uses sound waves. The~     study will determine if the antibiotic treatment and the standard of care improves the rate~     wound closure compared to the standard of care alone in persons with SCI and a chronic~     pelvic-region PU.~   "
75063|NCT02584413|"~     Currently, optic pathway gliomas (OPG) are detected based on abnormal findings made during~     annual ophthalmologic exams. However, because these exams are annual, it is possible for~     healthcare providers to miss the point at which a child's vision begins to decline~     (potentially indicating an OPG). If at-risk children are screened for hypotonia early in~     life, those children who are hypotonic may undergo magnetic resonance imaging (MRI) to~     evaluate for OPG before they are showing ophthalmologic symptoms. This would enable~     healthcare providers to discover vision loss earlier and treat symptomatic OPGs earlier,~     thereby allowing us a better chance of preventing further vision loss in children with OPGs.~   "
75064|NCT02584400|"~     Regulation of tissue oxygen homeostasis is critical for cell function, proliferation and~     survival. Evidence for this continues to accumulate along with our understanding of the~     complex oxygen-sensing pathways present within cells. Several pathophysiological disorders~     are associated with a loss in oxygen homeostasis, including heart disease, stroke, and~     cancer. The microenvironment of tumors in particular is very oxygen heterogeneous, with~     hypoxic areas which may explain our difficulty treating cancer effectively. Prostate~     carcinomas are known to be hypoxic. Increasing levels of hypoxia within prostatic tissue is~     related to increasing clinical stage, patient age and a more aggressive prostate cancer.~     Several researches indicated that hypoxia might also play a role in esophageal cancer. In~     glial brain tumors, hypoxia is correlated with more rapid tumor recurrence and the hypoxic~     burden in newly diagnosed glioblastomas is linked to the biological aggressiveness. In brain~     metastases CA-IX expression (a marker for hypoxia) is correlated to the primary non-small~     cell lung carcinomas. Hypoxia enhances proliferation, angiogenesis, metastasis,~     chemoresistance and radioresistance of hepatocellular carcinoma. The hypoxic markers HIF-1α,~     VEGF, CA-IX and GLUT-1 were all over expressed in colorectal cancer and its liver metastases.~     Based on literature, hypoxia in tumors originating or disseminated to prostate, esophagus,~     brain and rectum cancer will be studied in this trial.~   "
75065|NCT02584387|"~     This study seeks to examine a Virtual Reality Exposure Therapy (VRET) using the 3D Video~     Virtual Reality (VR) technology for the fear of spiders.~   "
75066|NCT02584374|"~     Iliac vein compression is a common cause of leg or abdominal complaints and is difficult to~     diagnose. Although a combination of duplex ultrasonography, magnetic resonance venography and~     two-plane phlebography are able to show compression, not all suspected iliac vein~     compressions can be identified. Intravascular ultrasound appears to have a higher diagnostic~     value, but is far more expensive. In our experience a balloon occlusion test in the common~     iliac vein during phlebography can diagnose iliac vein compression due to the collateral~     network that is visualised. The general consensus is that pelvic collaterals are a sign of~     pathology, though the investigators would like to validate this test by showing that a~     balloon occlusion test in healthy subjects does not identify a collateral network.~   "
75067|NCT02584361|"~     This study investigate weather one type of cochlear implant (CI) surgery (insertion of the~     electrode via paracentesis of the round window (RWA)) leads to less vertigo than another type~     of CI surgery (cochleostomy). The participants will be randomized into 2 groups: RWA or~     cochleostomy. They will be examined with a video head impulse test (vHIT) before and after CI~     surgery to clarify their vestibular function.~   "
75068|NCT02584348|"~     Anesthesia for emergency surgery is a situation at risk of pulmonary aspiration of gastric~     contents. It has been previously reported that bedside two-dimensional ultrasonography can be~     a useful tool for anesthesiologists to determine gastric contents and volume in adults and~     children.~      In this prospective study, preoperative qualitative ultrasound assessment of gastric contents~     is performed for each children admitted for emergency surgery, in order to plane in case of~     empty stomach an intravenous or inhalation technique induction rather than an rapid sequence~     induction.~   "
75069|NCT02584335|"~     The purpose of this study is to evaluate if applying a lidocaine topical solution before~     wounds treatment decreases the pain of the procedure in comparison with placebo solution.~   "
75070|NCT02584322|"~     Currently, at the CHUM - Notre-Dame Hospital, there is no standardized patient care pathway~     for patients undergoing Video Assisted Thoracic Surgery (VATS) lobectomy. The investigators~     goal is to implement an Enhanced Recovery Program (ERP) for patient undergoing VATS~     lobectomy.~      The care given to patient prior to the implementation of this protocol was different amongst~     patients and depended on the surgeon's preferences. The implementation of this ERP will~     permit a reproducible and routine management for patients following their surgery.~   "
75071|NCT02584309|"~     The purpose of this research study is to look at whether giving a drug called dexrazoxane~     plus olaratumab with standard of care doxorubicin affects the progression of the disease.~     Dexrazoxane is often given at the same time as doxorubicin to help reduce the incidence and~     severity of disease of the heart muscle (which can be caused by doxorubicin).~   "
75072|NCT02584296|"~     Physical Activity as a Self-Management Approach to Improve Health Outcomes in Acute Myeloid~     Leukemia~   "
75092|NCT02584036|"~     The primary objective of this study is to evaluate how implementing an innovative care model~     that provides the pharmacist access to a patient's vaccine history at the point-of-care~     impacts the pharmacist's ability to identify unmet vaccination needs and increase vaccination~     rates for routinely recommended adult vaccinations.~   "
75073|NCT02584283|"~     Rationale: Recent publications report good results of controlled donation after circulatory~     death (DCD) Maastricht category III liver transplantation when strict donor-recipient~     matching is applied and ischemia times are kept to a minimum. However a major concern remains~     the high rate of biliary complications after transplantation of DCD livers. Non-anastomotic~     biliary strictures (NAS) occur in 29% of patients receiving a DCD graft whereas the incidence~     of NAS in recipients of donation after brain death (DBD) liver grafts is 11%. NAS are~     associated with higher morbidity and increased cost of liver transplantation. Injury to the~     biliary epithelium and the peribiliary vascular plexus occurring during donor warm ischemia~     and static cold storage (SCS) has been identified as a major risk factor for development of~     NAS. Machine perfusion has been proposed as an alternative strategy for organ preservation,~     offering the opportunity to improve the quality of the organ by providing oxygen to the~     graft. Experimental studies have shown that end-ischemic dual hypothermic oxygenated machine~     perfusion (DHOPE) helps liver grafts to recover from ischemia by restoring mitochondrial~     function. Moreover, DHOPE has been shown to provide better preservation of peribiliary~     vascular plexus of the bile ducts, which could be an important step forward in reducing the~     incidence of NAS after transplantation.~      Objective: To study the efficacy of end-ischemic DHOPE in reducing the incidence of NAS~     within six months after controlled DCD (Maastricht category III) liver transplantation.~      Study design: An international, multicenter, prospective, randomized, controlled,~     interventional, clinical trial with a two parallel arm approach (treatment/control).~      Study population: Adult patients (≥18 yrs old) undergoing a liver transplantation with a~     liver graft procured from a controlled DCD donor (Maastricht category III) with a body weight~     ≥40 kg.~      Intervention: In the intervention group liver grafts will be subjected to two hours of~     hypothermic, oxygenated perfusion at the end of SCS and before implantation. In the control~     group donor liver grafts will be preserved in accordance to standard practice by SCS only.~      Main study parameters/endpoints: The incidence and severity of symptomatic NAS as diagnosed~     by an Adjudication committee (who are blinded for the group assignment) by means of magnetic~     resonance cholangiopancreatography (MRCP).~   "
75074|NCT02584270|"~     This study will fill a scientific gap in the current knowledge providing data for evaluation~     of the palatal augmentation prosthesis as a therapeutic modality in a robust scientific~     randomized prospective clinical trial. Positive outcomes from this study have the potential~     to dramatically alter the most common morbidity of oral cancer therapy, namely speech and~     swallowing function in a population of patients with T1/T2 tumors of the tongue who are not~     currently routinely recommended for a palatal augmentation prosthesis.~   "
75075|NCT02584257|"~     The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test~     product to the reference product, using bronchoprovocation (methacholine challenge testing)~     in adult patients with stable mild asthma.~   "
75076|NCT02584244|"~     The overall goal of this feasibility study is to assess the initial safety and efficacy of~     LUM015 in ex vivo far-red imaging of colorectal, pancreatic, and esophageal cancers~     (adenocarcinoma) using the LUM 2.6 Imaging Device.~   "
75077|NCT02584231|"~     Patients suffering from nocturnal enuresis (starting from the age of 5 till adulthood) are~     all treated with the same dose of desmopressin, i.e. 120mcg once daily. In treatment~     resistant enuresis, this dose is doubled: those patients take 240mcg once daily. A pilot~     study performed at our department showed a correlation between weight and plasma~     concentration when a fixed dose of desmopressin oral lyophilisate formulation was given to~     the pediatric patient (older than 6 years). This study will investigate the pharmacokinetics~     (PK) and pharmacodynamics (PD) of desmopressin in young children, less than 8 years old.~     Additionally, the efficacy of desmopressin oral lyophilisate formulation in urinary~     concentration testing will be evaluated~   "
75078|NCT02584218|"~     This study aims to evaluate, through a controlled clinical randomized study, the~     effectiveness of sealing carious lesions with composite resin in primary molars. For this,~     healthy children (n=100) with caries lesion reaching to the middle third of the dentin of~     primary molars, will be submitted to different treatments to remove the lesions. These~     patients will be randomly allocated in the following treatment groups: (1) cavity sealing~     (Non-invasive resin based dental sealing) without caries removal; and (2) Partial caries~     removal and Invasive resin based restoration. The clinical and radiographic success of the~     treatment groups will be verified by periodic examination of the restorations by USPHS~     criteria and radiographic subtraction, respectively, which will be checked progression or not~     of injury. The researcher responsible for these assessments will be blind to the study, whose~     evaluations will occur after 6, 12, 24 and 36 months of treatment.~   "
75079|NCT02584205|"~     Obstructive sleep apnea (OSA) is a chronic, progressive and disabling disease and can affect~     functional capacity due to the weakness of the respiratory muscles. Therefore, the objective~     of this study is to evaluate the effect of inspiratory muscle training on functional capacity~     in patients with OSA. A pilot study will be conducted to calculate the sample. Individuals of~     both genders, diagnosed with obstructive sleep apnea moderate or severe (measured by~     polysomnography) will be invited and the data collected in the Sleep Laboratory of the~     Pronto-Socorro Cardiológico de Pernambuco (PROCAPE), located in Recife- PE- BRAZIL. The study~     deals with a test-clinical randomized double-blind.The intervention groups held inspiratory~     muscle training (IMT) and the load is equivalent to 40% of maximal inspiratory pressure~     (MIP). The evaluations will be performed once a week during twelve weeks. Control groups will~     be submitted to a simulated training with load less than 10% of MIP (insufficient charge to~     train the muscles), during the same period as the intervention group. The guidelines for the~     training and weekly evaluations will be performed by the responsible for the researcher~     physiotherapist in Cardiopulmonary Physical Therapy Laboratory (LACAP- UFPE). After the~     training period, the groups will be reassessed by the evaluation tests of functional capacity~     (ADL- Glittre Test and Ergospirometry), inspiratory muscle strength (manometer) and lung~     function (spirometry) and then compared. Expected results: The interventional groups will~     improve their functional capacity.~   "
75080|NCT02584192|"~     The purpose of this study was to evaluate the effect of this CR program on the improvement of~     myocardial function using the three-dimensional speckle tracking echocardiography (3D-STE) in~     AMI patients.~   "
75093|NCT02584023|"~     Investigators hypothesized that lung ultrasound-assisted recruitment maneuver would be~     beneficial in mechanically ventilated infants compared to those who did not receive lung~     ultrasound and alveolar recruitment maneuver.~   "
75094|NCT02584010|"~     This study aims to determine if a silicon-based gel and a silicon-based aerosol are effective~     in the treatment of postoperative scars.~   "
75095|NCT02583997|"~     The main objective of this study is to evaluate postoperative pain (measured by visual~     analogue scale (VAS) on day 2 post surgery) in patients operated for avulsion of four wisdom~     teeth under general anesthesia and for whom the resulting alveoli were NOT sutured versus a~     similar group of patients undergoing standard care (suturing for lower alveoli).~   "
88098|NCT02413957|"~     The purpose of this study is to determine wether an extensive medication safety check has a~     greater impact on the incidence of adverse drug events than medication reconciliation or no~     intervention.~   "
75081|NCT02584179|"~     Our aim is to develop a new diagnostic approach to improve the diagnosis of men suspicious of~     having significant prostate cancer (sPCa). The current diagnostic technique (standard~     transrectal ultrasound-guided biopsies [TRUS-bx]) rely on multiple prostate biopsy cores~     (10-12 samples) and if negative repeated biopsy sessions. This increases both patient~     complications (severe infections, bleeding and anxiety) and the diagnosis of insignificant~     cancer causing overtreatment. Still, significant cancers are missed. In addition, worldwide~     antibiotic-resistant bacteria increase, while effective antibiotics are declining. Thus, a~     noninvasive diagnostic tool to improve selection of men with clinically suspicion of PCa who~     need a biopsy from those who can avoid one is strongly needed. Previous studies in our~     department show that MRI in a selected patient cohort with prior negative TRUS-bx can improve~     the detection rate of clinically significant PCa and allows for a more accurate assessment of~     cancer stage and aggressiveness. However, the value of an MRI used as a first-line tool in~     the diagnostic examination of men in suspicion of PCa is uncertain. Furthermore, a full scale~     MRI prostate examination recommended by the European Society of Urogenital Radiology includes~     intravenous contrast-media and multiple sequences. This is both time-consuming and cost full,~     which reduces its feasibility for more widespread clinical implementation. We believe that a~     simpler, faster biparametric MRI (bpMRI) using less scan sequences and circumvents~     intravenous contrast-media and anti-peristaltic drugs would decrease image acquisition time,~     reduce costs and is sufficient to preserve diagnostic accuracy for sPCa detection in~     biopsy-naive men. Consequently, we will include biopsy-naive men in a protocol-based research~     project. The objective is to assess the diagnostic accuracy of bpMRI to rule out sPCa and~     whether a bpMRI can be used as a diagnostic non-invasive screening tool to 1) improve the~     diagnosis of sPCa 2) assess cancer aggressiveness 3) increase precision of biopsies and 4)~     reduce the number of biopsy sessions and cores. We evaluate the clinical significance of the~     detected cancers and whether bpMRI could be used as a triage test to improve the diagnosis of~     sPCa and aid in the determination of which men could safely avoid unnecessary biopsies.~      This new diagnostic approach has the potential to significantly reduce patient hazards and~     complications. We aim to reach 1000 included men. We believe that bpMRI used in the clinical~     decision-making has the potential to change the future management of PCa. However, we still~     miss the scientific evidence to substantiate its preliminary promising results before this~     technique can be widely used to benefit all men. This large research project is to the best~     of our knowledge powered to include the largest patient sample size published within this~     field.~   "
75082|NCT02584166|"~     This cluster-randomised controlled trial will test the hypothesis that a multifaceted program~     with psychological intervention in morbidity mortality conferences (MMC) improve care quality~     and reduce the rate of morbidity mortality perinatal in diverse obstetric care settings.~   "
75083|NCT02584153|"~     Incisional hernias are a frequent consequence of abdominal surgery. Current clinical efforts~     are primarily focused on improving repair materials and surgical techniques to correct these~     hernias instead of the optimal solution: prevention.~      A product called MYOSEAL is currently being developed to prevent hernia formation after~     abdominal surgery by using fibrin tissue sealant and silver particles to prophylactically~     enhance the early wound healing of myofascial incisions. The purpose of this phase 1 study is~     to examine the safety of applying MYOSEAL immediately after abdominal wall suture closure in~     patients undergoing abdominal surgery. The investigators expect that applying this product to~     sutured myofascial incisions will increase collagen formation in the wound and thus prevent~     the formation of incisional hernias.~   "
75084|NCT02584140|"~     The purpose of this study is to test a program that uses drug level monitoring, text~     messaging (iTAB) and personalized counseling with HIV prevention services, including PrEP~     (medicine that can help prevent HIV infection when taken daily).~   "
75085|NCT02584127|"~     The study evaluates the effectiveness of an internet-based smoking cessation program for~     Korean Americans.~   "
75086|NCT02584114|"~     Background: People with psychosis show profound deficits in memory. A new cognitive~     remediation therapy using an app on a computer or mobile phone to improve memory has been~     effective in this population, but the neurobiological effects are unknown.~      Objectives: 1) To use functional magnetic resonance imaging (fMRI) to examine brain changes~     during a working memory task before and after a 12 hour memory training intervention on a~     computer or mobile phone, 2) To use diffusion tensor imaging (DTI) to examine white matter~     connecting prefrontal and parietal lobe before and after training.~      Methods: 46 people with psychosis will be randomized to a computerized training of either~     memory training or a control condition of non-memory games (language/card games) and will~     self-administer 4 hours of training over 4 days per week, for 3 weeks (12 hours total).~     Memory training will be done with the Peak app http://www.peak.net. Imaging data will be~     gathered with a 3 Tesla scanner pre and post training.~   "
75087|NCT02584101|"~     Background: Research has extensively documented the adverse impact that caring for an~     individual with an acquired brain injury can have including financial difficulties, social~     isolation, family tension and conflict, relationship difficulties, role adjustment and~     psychological distress (Foster et al., 2012). Research has indicated that Acceptance and~     Commitment Therapy (ACT) shows promise for increasing wellbeing and psychological flexibility~     in caregivers and could be a useful intervention for use with this population.~      Aims: The primary aim of this study is to investigate the feasibility of using an ACT~     intervention to enhance the wellbeing and the psychological flexibility of carers using the~     Population, Intervention, Control, and Outcomes (PICO) framework. Methods: The current study~     is a randomised control design, exploring the feasibility of comparing the efficacy of an ACT~     intervention to Enhanced Treatment As Usual (ETAU), to improve the wellbeing of the carers of~     adults with an acquired brain injury (ABI). Participants will be recruited from the Brain~     Injury Rehabilitation Trust (BIRT) in Glasgow, Scotland and randomly assigned to either an~     ACT intervention group or TAU control group. Both will be assessed in parallel to one another~     completing a range of baseline and post-baseline measures. Applications: This feasibility~     study will provide information for further research on the utilisation of an ACT intervention~     to improve the wellbeing of carers and whether this is an acceptable intervention for this~     population.~   "
75088|NCT02584088|"~     -  The study primarily aims to evaluate the post ablative endometrium and uterus using~          transvaginal ultrasound to provide descriptive information as to what may be expected in~          the 12 months after a NovaSure ablation. Investigators believe this knowledge will help~          them to determine when to proceed with further evaluation postoperatively or when to~          counsel patients on expectant management based on ultrasonographic findings.~        -  Secondary aims include correlation of ultrasonographic findings to demographic patient~          data.~   "
75089|NCT02584075|"~     Type 2 diabetes mellitus (T2DM) is an important risk factor of cardio-cerebral vascular~     disease such as coronary heart disease. GLP-1 is a kind of incretin secreted by the L-cell~     located in Ileum. It acts as an incretin hormone by protentiating glucose-stimulated insulin~     release. Recent studies reported that GLP-1 RA can protect the vascular endothelial and~     prevent vascular from atherosclerosis. Investigators design this study to investigate~     exenatide's effect on the improvement of the coronary endothelial function by evaluating~     endothelium dependent diastolic function and testing the vascular endothelial active~     substance and related inflammatory factors.~   "
75096|NCT02583984|"~     Acute lung injury (ALI) following thoracic surgery remains a major source of morbidity and~     mortality after lung resection. One-lung ventilation (OLV) is usually required in thoracic~     surgery. OLV is also an important predictor of postoperative ALI. Recent laboratory findings~     suggested that tissue hypoxemia and ischemia / reperfusion injury of the collapsed lungs~     during OLV is the major cause of lung injury. Exhaled Breath Condensate (EBC), which is the~     exhalate from breath typically collected by cooling device, contains most molecules found in~     the airway. Metabolomics refers to systematic and scientific study of chemical processes~     involving metabolites. This study will collect EBC for metabolomic analysis and aim to~     elucidate the biochemical reactions during one-lung ventilation and pathological mechanisms~     of acute lung injury following thoracic surgery.~   "
75097|NCT02583971|"~     Investigators will assess the impact of treatments for atrial fibrillation on participant's~     thrombotic status~   "
75098|NCT02583958|"~     Assessment of efficacy and safety for a new wound dressing URGO 310 3166 in the local~     treatment of venous or mixed leg ulcers: a European, randomised clinical trial.~   "
75099|NCT02583945|"~     Postoperative acute kidney injury (AKI) refers to increased mortality and morbidity in~     patients after non-cardiac surgery. The Kidney Disease Improving Global Outcomes~     (KDIGO)-guidelines recommend a bundle of procedures to prevent the occurrence of AKI: A~     protocol for the improvement of the hemodynamic situation and a standardized proceeding in~     hemodynamic monitoring, consequent avoidance of nephrotoxic substances, regular measurement~     of creatinine and urine output, as well as normoglycemia. The primary goal is to determine if~     the consequent application of the KDIGO-bundle leads to a prevention of the occurrence of AKI~     in patients at risk after non-cardiac surgery.~   "
75100|NCT02583932|"~     To test whether the Meaning-Making intervention (MMi)(Lee, 2004) plus usual care increases~     the sense of meaning in life in people newly diagnosed with any type of advanced cancer,~     compared to similar people who receive 1) usual care alone or 2) usual care plus visits from~     an empathic visitor, at 2 months after randomization to one of these treatments. The~     investigators will also evaluate whether any effect is present at 4 and 6 months~     post-randomization, and the MMi's impact on anxiety/depression, quality of life, existential~     wellbeing, and posttraumatic growth. To answer our research questions 471 newly diagnosed (<6~     months) advanced cancer patients (stages III or IV) will be studied.~   "
75101|NCT02583919|"~     The purpose of this study is to evaluate the efficacy, safety, and tolerability of~     ISIS-GCGRRx in combination with metformin versus placebo~   "
75102|NCT02583906|"~     Evaluation of the effect of CPAP (continuous positive airway pressure ) treatment in PAH~     (pulmonary arterial hypertension) and CTEPH (chronic thromboembolic pulmonary hypertension)~     patients suffering from sleep disordered breathing.~   "
75103|NCT02583893|"~     This pilot phase II trial studies whether biomarkers (biological molecules) in bone marrow~     samples can predict treatment response to sirolimus and chemotherapy (mitoxantrone~     hydrochloride, etoposide, and cytarabine [MEC]) in patients with acute myeloid leukemia (AML)~     that is likely to come back or spread (high-risk). Sirolimus inhibits or blocks the pathway~     that causes cancer cells to grow. Adding sirolimus to standard chemotherapy may help improve~     patient response. Studying samples of bone marrow from patients treated with sirolimus in the~     laboratory may help doctors learn whether sirolimus reverses or turns off that pathway and~     whether changes in biomarker levels can predict how well patients will respond to treatment.~   "
75104|NCT02583880|"~     This is a survey which will be performed on a specific day (the Screening Day) in Latin~     American ICUs.~      In eligible patients who receive enteral or parenteral nutrition a retrospective calculation~     of the caloric deficit will be performed. The caloric deficit is the difference between~     energy target of each patient and actually administered calories.~   "
75105|NCT02583867|"~     50 subjects with Major Depressive Disorder who are not currently receiving treatment will be~     enrolled in a 12-week exercise program, supervised by a trained exercise interventionist.~   "
75106|NCT02583854|"~     The transradial route is used in 90% of the coronary angiograms performed at Oslo University~     Hospital (OUS), Ullevål. A compression device needs to be applied after the procedure to~     achieve hemostasis. Patients and staff will benefit from using a device that yields safe and~     painless hemostasis.~      Patients will be randomly assigned to receive either the standard compression device (control~     group, A) or a recently developed compression device (experimental group, B). The study will~     be designed as a non-inferiority, prospective randomized controlled trial, with outcome~     measures being patient comfort during compression time and complication rates. Complications~     that will be measured are radial artery occlusion (RAO) measured using ultrasound at a follow~     up visit. Hematomas or bleeds from the puncture site after application of the compression~     device will also be classified as complications.~      The aim of the study is to investigate whether the new device, RY-STOP is non-inferior~     compared to the standard device, when considering the outcome measures.~   "
75107|NCT02583841|"~     Aim:~      To evaluate effect of non- surgical periodontal therapy on liver function in systemically~     healthy chronic periodontitis (CP) subjects.~      Materials and methods:~      The study is non surgical interventional trial, includes 50 CP subjects in the age group of~     35- 60 years selected from the OPD (Out Patient Department) of department of periodontology~     Tatyasaheb Kore Dental College and Research center (TKDC and RC), Kolhapur. CP subjects were~     equally divided into test group and control group. Liver function test- aspartate~     aminotransferase (AST), alanine aminotransferase (ALT) were checked at baseline and at 1~     month after treatment. Clinical examination includes plaque index, gingival index, sulcus~     bleeding index, probing depth, clinical attachment loss.~   "
75108|NCT02583828|"~     This is a randomized clinical trial to investigate the efficacy of letrozole combined with~     metronomic oral cyclophosphamide in elderly metastasis breast cancer patients.~   "
75109|NCT02583815|"~     This is an open label feasibility pilot study of commercially available physical activity~     monitoring devices in patients receiving systemic therapy at the Harold Simmons Cancer~     Center, UT Southwestern Medical Center.~   "
75117|NCT02583698|"~     250 Acute on chronic liver failure patients with HVPG (Hepatic Venous Pressure Gradient) ≥ 12~     mmHg + No/small esophageal varices who present to the Department of Hepatology at Institute~     of Liver and Billiary Sciences, who meet the inclusion criteria and who provide informed~     consent.~   "
75110|NCT02583802|"~     This clinical study is to observe the improvement of MHD (maintenance hemodialysis) patients,~     quality of life，after applying therapy combining Auriculotherapy and Shengmai capsule. As a~     compliment to each other, Traditional Chinese Medicine and Modern Medicine form a joint and~     help improving life quality of MHD patients. Through the therapy, MHD patients, symptoms of~     thirst are improved, the incidence of intradialytic hypotension is reduced, the intake of~     water and sodium is lessen and the weight gain during dialysis is controlled, which~     consequently reduce cardiovascular and cerebrovascular complications and eventually reduce~     the mortality of MHD patients. Aiming to improve patients, thirst symptom and reduce the~     incidence of intradialytic hypotension, this study prospectively followed 144 MHD patients~     using multicenter prospective randomized crossover controlled clinical studies, using KT/V,~     URR, improvement of thirst, blood pressure and cognitive assessment as observational index.~     Multiple questionnaire surveys are conducted to understand patients, life quality from~     different angle. The use of Auriculotherapy is simple and effective and Shengmai capsule~     conforms to patients, syndrome, which is consistent with TCMs principle of syndrome~     differentiation and treatmentand the theory of preventive treatment. The study not only~     expends the use of TMC in hemodialysis treatment, but also suggests a set of easy therapeutic~     schedules to improve the quality of life in patients receiving hemodialysis treatment.~   "
75111|NCT02583789|"~     This study represents the first trial to assess the efficacy of oral treprostinil therapy in~     patients with symptomatic primary or secondary Raynaud's Phenomenon (RP) resistant to~     vasodilatory therapy.~      The study will be randomized 1:1 UT-15C to placebo. The design is a crossover study and all~     subjects will be randomized to receive oral treprostinil sustained release tablets or~     matching placebo for 12 weeks and then crossover for 12 weeks. All subjects will be exposed~     for 12 weeks of treatment with oral UT-15C during the study.~   "
75112|NCT02583776|"~     Neonatal hypoglycemia is associated with brain injury and impaired neurodevelopment outcomes~     in very low birth weight infants (VLBWI). Glycemic monitoring is usually performed by~     capillary or central line sampling but does not identify up to 81% of hypoglycemic episodes~     in preterm newborns.~      The investigators aim to assess if a continuous glucose monitor (CGM) can be used to maintain~     euglycemia (defined as a target value 72-144mg/dl) in VLBWI.~      It will be enrolled newborns ≤32 weeks gestational age and/or of birthweight ≤1500 g, within~     48 hours of life, they will be randomized in two study arms, both them will wear Dexcom G4~     Platinum CGM: 1) Unblinded group (UB): glucose daily intake will be modulated according to~     CGM (Dexcom G4 Platinum) during the first 7 days of life, alarms for hypos/hyper will be~     active; 2) Blinded group (B), glucose infusion rate will be modified according to 2-3 daily~     capillary glucose tests, alarms for hypos will be switched off. Pain at insertion will be~     evaluated with the validated Premature Infant Pain Profile (PIPP) scale.~      The estimated numerosity is 50 patients (25 for each arm).~   "
75113|NCT02583763|"~     The aim is to increase awareness of the relationship between (IUGR) and cardiac function in~     the foetus, the development of cardiac function over time after delivery and what~     significance a possible early disturbed myocardial function have for the neonate and the~     child during the first years of life.~   "
75114|NCT02583750|"~     This project investigated how glucose metabolism differs due to sleep deprivation for three~     consecutive nights as compared to sufficient sleep for three nights by examining~     concentrations of glucose, insulin, and other factors involved in glucose metabolism.~   "
75115|NCT02583737|"~     Bone resorption and atrophy in maxillary posterior region is due to severe periodontal~     disease and is consequent tooth extractions. Sinus pneumatisation can occur after tooth~     extraction and alveolar bone loss. Consequently, bone-reducing volume at that region is a~     great challenge to implantodontists. Sinus lifting surgery have been practiced since 80's and~     many biomaterials have been used to solve filling issues to maintain the sinus floor lifted~     in a position that can allow dental implants installation. Bone grafts have shown to be the~     best choice of filling grafts. Despite autologous bone are the gold standard filling~     biomaterial it is associates with great mortality and morbidity. So, bone allografts from~     tissue bank had been shown to be an advantageous alternative. Lyophilized or freeze tissue~     bone are the most common allografts but literature is poor in randomized controlled parallel~     clinical trials regarding those filling grafts for sinus lifting. The aim of this study is to~     perform a randomized controlled clinical trial comparing two bone allografts: lyophilized and~     freeze bone allografts from human bone tissue bank. The investigators want to verify which~     one can develop greater osteogenesis, if is there any difference between them regarding the~     architectural trabeculae formation, if there are different patterns of reabsorption and~     finally if is there any differences between them regarding primary and lately dental implants~     stability. To answer those questions the investigators propose firstly, to carry out~     microtomographic and histological analysis from trephine bone samples after six months of~     sinus lifting and grafting in healthy participants undergoing osseointegrated dental~     implants. Secondly, the primary and lately implant stability is going to be achieved~     employing Resonance Frequency Analysis (RFA).~   "
75116|NCT02583711|"~     This is an observational study, which aims to assess how physical activity levels following~     surgical procedures correlate with patient recovery and length of hospital stay, as well as~     the utility of this physical activity data to the postoperative surgical team. Surgical teams~     frequently enquire about their patients' physical activity levels on postoperative ward~     rounds. Although this information is often provided anecdotally by nursing staff and junior~     doctors, there are no objective data made available to the clinician. Such data has the~     potential to supplement other observations (e.g. heart rate, blood pressure, temperature) to~     help gain an impression of a patient's recovery and physical status, this in turn could~     provide evidence to help facilitate early discharge as well as to predict medium to longterm~     outcomes. Advances in wearable technology allow the investigators to collect detailed~     information with regard to activity with minimal disruption.~      Recent literature has shown that these wristworn sensors can feasibly be worn in hospital pre~     and postoperatively, with evidence of a correlation between the amount of steps taken~     postoperatively and the length of hospital stay. This study will provide further evidence for~     the usability and utility of wearable sensors in the inpatient surgical setting. It will~     provide supporting evidence for surgeons to confidently analyse and assess patients in~     hospital, allowing for safe and expedient discharge home as well as identify highrisk~     patients who are likely to require extra support and surveillance in the community setting.~   "
75121|NCT02583646|"~     Background:~      Studies suggest that overweight girls may be developing breast tissue, and therefore starting~     puberty, earlier than normal weight girls. However, it is hard to distinguish breast tissue~     from fatty tissue. Researchers think that by using breast ultrasound, among other tests, they~     can do a better job of telling whether an overweight girl has breast tissue. This will help~     them understand if overweight girls are truly entering puberty before normal weight girls.~      Objective:~      To find out if overweight girls go through puberty earlier than normal weight girls.~      Eligibility:~      Healthy girls 8-14 years old who:~        -  Are normal weight or overweight~        -  Have some breast development~        -  Have not started their first period~      Design:~      Parents of participants will be screened over the phone.~      Most participants will have 1 visit. However, they can choose to have multiple visits within~     4 weeks. The visit will include:~        -  Physical exam that includes examination of the breasts and genital area~        -  Breast ultrasound: A small hand-held device will be passed back and forth over the~          chest. It uses sound waves to create a picture of the breast tissue.~        -  Pelvic ultrasound: A small, handheld device will be passed back and forth over the lower~          belly. It uses sound waves to create a picture of the ovaries.~        -  Urine and blood test~        -  A special x-ray called a DXA to measure the amount of fat in the body: The participant~          will lie still on a table while the x-ray takes pictures of the body.~      X-ray of the hand: The picture will tell researchers how mature the participant s bones are.~      Participants may be asked to come back 6 months later to repeat these tests.~   "
75122|NCT02583633|"~     One of the important complications of pregnancy is preterm labor (PTL) and delivery. There~     are different tocolytic agents to enhance the time of delivery. The aim of this study was to~     compare the effect of transdermal nitroglycerin (glyceryl trinitrate, GTN) and oral~     nifedipine for managing preterm labor. This was a randomized clinical trial in women admitted~     with diagnosis of PTL. Group one have received transdermal GTN whereas group two have~     received oral nifedipine, vital signs, FHR, contractions, dilation and effacement as well as~     gestation age at the time of delivery have been monitored and evaluated in both groups of~     patient. Our main goal has been delay of delivery to have the most beneficial effect of~     primary corticosteroid administration for fetus.~   "
75123|NCT02583620|"~     Compelling evidence of genetic components in high myopia has been put forward by several~     studies. Twin cohorts, familial linkage studies and population studies has described at least~     10 loci containing genes involved in the disease development. The investigators previously~     demonstrated novel linkage on chromosome 7q36 and chromosome 7p15 in French families. A new~     approach consisting of a case-control based population association study is underway in order~     to recover a high number of myopic subjects avoiding the limitation of familial cases. 1.8~     millions polymorphic markers will be compared with emmetropic controls in order to recover~     loci associated with the disease in the population.~   "
75124|NCT02583607|"~     Breast reconstruction is one of the most challenging aspects in plastic surgery. One of the~     most sophisticated methods of breast reconstruction is using of autologous fat grafting.~     Brava is a device that invented by Dr Roger Khouri, and is intended to improve the final~     results of fat grafting.~   "
75125|NCT02583594|"~     Primary Objective:~        -  To characterize the pharmacodynamic profile of 2 treatment courses of alemtuzumab~          administered by subcutaneous injection and 2 treatment courses of alemtuzumab~          administered by intravenous infusion in patients with progressive multiple sclerosis.~      Secondary Objectives:~        -  To characterize the pharmacokinetic profiles of alemtuzumab administered by subcutaneous~          injection or intravenous infusion to patients with progressive multiple sclerosis.~        -  To characterize the safety and tolerability of alemtuzumab administered by subcutaneous~          injection or intravenous infusion to patients with progressive multiple sclerosis.~   "
75126|NCT02583581|"~     This study evaluates the use of brain activity monitoring for prediction of migraine attacks~     in an expected time scale of 12-48 hours prior to the migraine attack.~   "
75127|NCT02583568|"~     A need for further investigation for fluorescence image-guided surgery in breast conserving~     surgery (BCS) has arisen following the results obtained from a phase I feasibility breast~     cancer trial (BIRDYE study: ABR NL 37479.042011). The aim of this study is to define the~     optimal dose of the fluorescent tracer Bevacizumab-IRDye800CW for intraoperative delineation~     of breast cancer tissue using the improved and optimized fluorescent tracer and camera~     system.~   "
75128|NCT02583555|"~     The purpose of this study is to identify persons with high risk of frequent hospital~     admissions and by counselling by one in depth interview followed by frequent telephone~     contacts improve their quality of life and reduce their healthcare utilization.~   "
75129|NCT02583542|"~     Selumetinib (AZD6244) and AZD2014 are two new anti-cancer treatments that AstraZeneca are~     developing; they are both not yet approved for clinical use.~      Selumetinib (AZD6244) is a drug that acts by blocking a protein called MEK, which has been~     linked to the development and growth of multiple cancers. AZD2014 is a drug that blocks a~     protein called mTOR that is involved in the growth and spread of cancer. Blocking the action~     of either MEK or mTOR alone may slow down or stop the cancer growing. Combining both drugs~     may make the cancer more sensitive than if Selumetinib (AZD6244) or AZD2014 are used alone~     and therefore this dual treatment may lead to increased anti-tumour effects.~      Although Selumetinib (AZD6244) and AZD2014 given alone and in combination with other~     anti-cancer drugs have been tested in people with advanced cancer, the specific combination~     of Selumetinib (AZD6244) and AZD2014 has not been used in people before. Therefore Phase 1b~     (Dose Escalation Phase) will determine what the recommended dose to use in Phase IIa (Dose~     Expansion Phase) will be. Efficacy, progression free survival, duration of response, and~     overall survival, will then be assessed in patients with triple-negative breast cancer, and~     Non small cell lung cancer within Phase IIa.~   "
75130|NCT02583529|"~     Dysfunctions of the lower urinary tract are non-motor symptoms common engines in Parkinson's~     disease (PD). Urodynamic changes in PD include overactive bladder (OB), characterized by~     urgency with or without urge incontinence , usually with frequency and nocturia . The aim of~     this study is to evaluate the efficacy and effectiveness of the treatment of OB in patients~     with PD with the use of a specific treatment: Posterior Tibial Nerve Electrostimulation~     (PTNE).~   "
75197|NCT02582658|"~     The study seeks to provide evidence of the effectiveness and obtain patient reported outcome~     (PRO) and work productivity data of the interferon-free ABBVIE REGIMEN +/- Ribavirin (RBV) in~     chronic hepatitis C virus infected participants in Austria.~   "
75132|NCT02583503|"~     When carrying out a knee replacement operation one of the goals is to correct any deformity~     of the leg (bowlegged or knock kneed). The ideal alignment is the mechanical axis, which is a~     line from the centre of the hip joint to the centre of the ankle. This line indicates how the~     weight of the body is transmitted to the ground via the leg. Often the planning for a knee~     replacement uses an Xray which shows the hip, knee and ankle (HKA Xray) so that the~     mechanical axis can be drawn on.~      However, the weight of the body goes to the ground from the ankle through the heel. There~     have been some reports recently suggesting that deformities in the heel can influence the~     overall leg alignment after a knee replacement; this may affect how successful the surgery~     is, or how long the knee replacement will last. Therefore it may make sense to take the~     alignment of the leg including the heel in planning for a knee replacement.~      The conventional practice to assess the alignment of the heel is a hindfoot alignment view~     (HAV) Xray. This only shows the foot. Having two separate Xrays means more radiation exposure~     and makes linking the two alignments very difficult. We propose a single novel Xray extending~     the HKA Xray to shows hip, knee, ankle and heel (HKAH Xray) enabling measurement of both~     alignments.~      This study is to validate the hindfoot alignment seen on the novel Xray with the standard~     HAV. Patients undergoing a knee replacement will be enrolled. Patients will have both a HKAH~     and HAV Xray before surgery. The alignment of the heel measured on the HKAH Xray will be~     compared with the standard HAV to see if it is accurate.~   "
75133|NCT02583490|"~     This protocol proposes a pilot randomized clinical trial to examine whether Low Pulse~     Amplitude Focal ECT (LAP) has a more favorable cognitive profile compared to conventional~     unilateral ECT and that it has similar effects as traditional ECT in reducing suicidality.~     The study will enroll 10 patients recruited from the Medical College of Georgia (at Georgia~     Regents University/Augusta University, GRU/AU) as the only site of the study. Eligible~     participants will be randomly assigned (1:1 ratio) to receive a course of either RUL LAP ECT,~     or conventional RUL ECT.~   "
75134|NCT02583477|"~     A Phase Ib and II Open-Label, Multi-Center Study of MEDI4736 Evaluated in Different~     Combinations (with chemotherapy or AZD5069) in Patients with Metastatic Pancreatic Ductal~     Adenocarcinoma~   "
75135|NCT02583464|"~     Objective: To evaluate the relative bioavailability of a new formulation containing a~     combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg (T) and compare~     this formulation with the branded formulation (R) to meet regulatory criteria for marketing~     the test product in Argentina.~   "
75136|NCT02583451|"~     This is a randomized, double-blind, placebo- and active-controlled, 4-period crossover study~     of lemborexant in healthy adult and elderly subjects to evaluate driving performance~   "
75137|NCT02583438|"~     The intestinal microflora imbalance has been associated with obesity and type 2 diabetes. The~     researchers' study aimed to investigate the effect of saxagliptin on gut microbiota in~     patients with newly diagnosed type 2 diabetes.~   "
75138|NCT02583425|"~     Efficacy and Safety Pilot Study of DFN-11 Injection in Medication Overuse Headache~   "
75139|NCT02583412|"~     The overall aim of this study is to determine if an accelerated Bexsero® (Multicomponent~     meningococcal B vaccine) schedule compared to a standard schedule is immunogenic, safe, and~     tolerable, in order to increase capacity for rapid outbreak control. In this pilot study no~     formal hypothesis is tested.~   "
75140|NCT02583399|"~     The primary objective of this study is to evaluate the pharmacokinetic profile of a single~     dose of intravenous ibuprofen administered over approximately ten (10) minutes.~   "
75141|NCT02583386|"~     The purpose of this study is to examine whether an exercise and educational classroom program~     can help reduce falls in people with Multiple Sclerosis who fall frequently.~   "
75142|NCT02583373|"~     The objectives of this study are to assess the safety, tolerability, clinical and~     microbiological efficacy and pharmacodynamics of patients who have severe pneumonia caused by~     Streptococcus pneumoniae after the intravenous administration of CAL02 in addition of~     standard of care antibiotic treatment.~   "
75143|NCT02583360|"~     The purpose of the investigator's study is to evaluate the causes of feeding difficulty in~     infants. New treatments can be possible only if the cause is known. In this study, the~     investigator plans to evaluate the movement of the muscles in an infant's mouth, throat~     (pharynx) and food pipe (esophagus) that are responsible for moving the food down into the~     stomach and that help protect an infants airway.~   "
75144|NCT02583347|"~     Sleep disorders are common in patients who have chronic kidney disease (CKD). Insomnia is~     reported in up to 50% of patients treated with hemodialysis compared to 12% of a control~     population. Restless leg syndrome (RLS) and periodic limb movement disorder (PLM) have been~     described in 30 to 70% of patients with end stage kidney disease (ESKD). Patients with CKD~     have also been reported to have a very high prevalence of sleep apnoea disorder. Conventional~     hemodialysis and peritoneal dialysis do not appear to improve sleep disorders in patients~     with CKD. There is emerging evidence that nocturnal HD can lead to improvements in sleep~     quality. Transplantation is thought to improve sleep-related disorders in some but not all~     patients.~      Project Aims~      The aims of this project were three-fold:~        1. To perform detailed assessment of sleep quality in a cohort of Irish patients with ESRD~        2. To assess the feasability and tolerability of unattended home PSG and wrist actigraphy~          as diagnostic tools in this cohort~        3. To assess the impact of a change in RRT modality on sleep quality in Irish patients with~          ESRD~   "
75145|NCT02583334|"~     Fibromyalgia is the second most common autoimmune rheumatic diseases with clinical~     manifestations of widespread pain, fatigue and accompanied cognitive and emotional~     disturbances. It often associated with sleep disorders and headaches. The cardinal symptom of~     fibromyalgia is widespread pain. Clinical observations reveal that pain in patients with~     fibromyalgia could not simply improve by using analgesics only. Patients often use Chinese~     medicine or acupuncture to help them to ease the pain.~      The aim of this study is to investigate the efficacy of acupuncture in patients with~     fibromyalgia. The study adapted a randomized, assessor- and participant-blinded,~     sham-controlled, and parallel-design approach to investigate whether acupuncture can improve~     the clinical symptoms and quality of life as well as the mechanism through laboratory~     biochemistric and image study.~   "
75198|NCT02582645|"~     In this investigation the investigators would like to find out which of two commonly used~     techniques of management of palatally impacted canines: closed-window (CWT) or open-window~     (OWT), produces more favorable outcome.~   "
75146|NCT02583321|"~     Recent meta-analysis have suggested that the safety of oral care with chlorhexidine in~     patients under mechanical ventilation could be questionable. Whatever the hypothetical~     mechanisms involved (direct cellular toxicity, underdiagnosis of Ventilator-Associated~     Pneumonia), presence of chlorhexidine in tracheal secretions after routine oral care is the~     cornerstone of this potential side effect of the routine oral care with chlorhexidine~     gluconate. The DEMETER study assessing the medico-economical impact of the subglottic~     secretions drainage study (NCT02515617) provides the opportunity to perform this proof of~     concept study (detection of chlorhexidine in tracheal secretions after routine oral care with~     chlorhexidine gluconate) and to evaluate the impact of the subglottic secretion drainage on~     this potential detection of chlorhexidine.~      This ancillary study will be performed in one of the centers participating to the DEMETER~     study.~   "
75147|NCT02583308|"~     Meta-analysis provide evidence for the benefit of the subglottic secretions drainage (SSD) to~     reduce the occurrence of Ventilator-Associated Pneumonia (VAP). Nevertheless, the diagnosis~     of VAP is widely considered as subjective and prone to both false-positive and false negative~     assignments. In ths way, the impact of SSD remains controversial and its use limited in~     Intensive Care Units. The DEMETER study assessing the medico-economical impact of the the~     subglottic secretions drainage (NCT02515617) provides the opportunity to evaluate the~     dynamics of tracheal colonisation with and without the realisation of SSD. This evaluation~     would reinforce the results observed during the DEMETER study in considering the adjudicated~     VAP incidence.~      This ancillary study will be performed in 14 centers participating to the DEMETER study~   "
75148|NCT02583295|"~     Awareness during anesthesia with intraoperative memory occurs when the patient is able to~     process information and produce specific responses to several stimuli. Anecdotal evidence~     suggests that children exposed to therapeutic suggestion consisting of gently encouraging,~     positive words spoken to them during emergence from anesthesia seem to arouse after surgery~     with less agitation, less pain and lower requirements for pain medications. Therapeutic~     suggestion has been associated with positive results in some adults during surgery, but it is~     unknown how therapeutic suggestion affects children. A newborn's recognition and preference~     for their mother's voice occurs early in life, very likely during fetal development.~     Additional evidence, revealed that at least as early as 4 months of age, infants process~     auditory stimuli from their mother's voice at a higher amplitude than they process auditory~     input from female strangers, suggesting that maternal voice stimuli undergo a unique form of~     cerebral processing that lends support for the existence of neurophysiologic mechanisms that~     reflect a child's preference for his/her mother's voice. This study aims to evaluate and~     compare the possibility of intra-operative awareness prevention by using either music~     listening or maternal sound listening in children undergoing cardiac surgery.~   "
75149|NCT02583282|"~     Malignant pleural effusion (MPE) arises in advanced-stages of malignancies and frequently~     heralds a poor prognosis.If the underlying malignancy is chemo sensitive (e.g., small-cell~     carcinoma of lung & lymphoma), systemic chemotherapy may control the pleural effusion.~     Instilling of sclerosing agents into the pleural cavity (pleurodesis) is a common method for~     the management of MPE. According to a recent survey, tetracycline or its derivative~     (doxycycline) is the preferred agent for performing pleurodesis at many centers. In a~     previous study from the investigators' center, the investigators have demonstrated equal~     efficacy of iodopovidone in comparison to talc in inducing pleural symphysis. Also,~     iodopovidone has been postulated to have anti-neoplastic effects and hence may help in~     reducing the drain output. Apart from these benefits iodopovidone is easily available and is~     cost effective. The investigators believe that iodopovidone will have better efficacy than~     doxycycline in inducing pleurodesis in malignant pleural effusion.~   "
75150|NCT02583269|"~     This phase I trial studies the side effects and the best dose of muscadine grape skin extract~     (MGE) in treating patients with malignancy (tumor or cancer) that has spread to other parts~     of the body or cannot be removed by surgery. MGE is a nutritional supplement containing an~     extract of the skin of muscadine grape that has shown anti-cancer activity in laboratory~     studies and may be able to fight or kill malignant cells.~   "
75151|NCT02583256|"~     Safety, Immunogenicity of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared~     to Non-Adjuvanted Comparator Influenza Vaccine in Children Previously vaccinated in Trial~     V118_05. Subjects will receive either the Same or Alternate Type of Vaccine.~   "
75152|NCT02583243|"~     Project BEST is a clinical project funded by the Substance Abuse and Mental Health Services~     Administration (SAMHSA) to increase treatment to opiate dependent patients with mental~     illness in New Haven, CT and to prospectively follow everyone enrolled in buprenorphine care~     for as long as the individual takes buprenorphine to track the success of buprenorphine for~     the maintenance of opiate dependence.~   "
75153|NCT02583230|"~     The goal of this project is to develop and pilot a mobile smartphone delivered intervention~     that will improve antidepressant medication care by providing medication adherence monitoring~     and support to the patient, feedback on patient adherence and response to treatment to the~     primary care team, and information to both patients and providers on guideline-congruent care~     personalized to the patient's response to antidepressant medication.~   "
75154|NCT02583217|"~     Laryngeal mask airway is a common tool for airway management during anesthesia in many~     surgeries. Insertion of laryngeal mask needs deep anesthesia, suppression of airway, stabile~     hemodynamic response. Many drug regimens has been used for this purpose. This study aimed to~     compare the insertion conditions of laryngeal mask by using ketamine+propofol versus~     remifentanil + propofol.~   "
75155|NCT02583204|"~     The study compares three strategies to prevent/minimise nail problems occuring in women, with~     breast cancer, undergoing Taxane chemotherapy. The strategies are: application of nail polish~     and normal care; application of Onicolife drops and normal care and; normal care only.~   "
75156|NCT02583191|"~     The purpose of this study is to show feasibility (efficacy and safety) of Rivaroxaban in the~     treatment of VTE in cancer patients in comparison to the standard treatment with low~     molecular weight heparin (LMWH).~      Tumor patients with active cancer and newly diagnosed thromboembolic events are randomised to~     receive either Rivaroxaban or the standard treatment with low-molecular heparin.~   "
75199|NCT02582632|"~     This study will evaluate the safety and efficacy of ombitasvir/paritaprevir/ ritonavir and~     dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b (GT1b)~     hepatitis C virus (HCV).~   "
75157|NCT02583178|"~     The purpose of this study is to assess the safety and function of the Aegis Sierra Ligation~     System in accessing and closing off the left atrial appendage (LAA) using a minimally~     invasive epicardial access approach.~      A minimum of 30 participants will be included in this study, which is being performed at a~     maximum of 8 centers in Canada and the United States. (A maximum of 5 participants at 4 US~     centers will be enrolled)~      Participants will be considered for this treatment if their doctor(s) have determined they~     have documented non-valvular atrial fibrillation and are at increased risk for developing a~     stroke.~   "
75158|NCT02583165|"~     To evaluate the safety and tolerability of MEDI1873 in adult subjects with selected advanced~     solid tumors.~   "
75159|NCT02583152|"~     Mucopolysaccharidoses (MPS) are currently treated with Enzyme replacement therapy and Bone~     Marrow Transplantation (BMT). No current evidence on the effectiveness on these therapies on~     the eye in this systemic disease is avalible. Using new imaging techniques; previously~     subjective data can be quantified and compared to determine if there is an improvment in the~     vision of patients with MPS.~   "
75160|NCT02583139|"~     The purpose of this study is to determine whether a specially-designed music-narratives are~     effective in reducing side effects of chemotherapy in 7- to 12-year-olds with cancer.~   "
75161|NCT02583126|"~     The purpose of this study is to determine whether a modified and resource-oriented form of~     Guided Imagery and Music (GIM) is effective in reducing side effects of chemotherapy in~     teenagers with cancer.~   "
75162|NCT02583113|"~     To determine if there is a patient satisfaction preference of Total Knee Arthroplasty (TKA)~     vs Unicompartmental Knee Arthroplasty (UKA) in patients with bilateral knee osteoarthritis~     who underwent a primary TKA one side and a primary UKA on the opposite side and are at a~     minimum of two years post-surgery. Patient reported outcomes and data with be analyzed along~     with all retrospective chart data.~   "
75163|NCT02583100|"~     This is a pilot study to determine if an audit and feedback intervention decreases~     complication rates after cleft palate surgery.~   "
75164|NCT02583087|"~     This study assesses the quality of the resection of early neoplasia arinsing in Barrett's~     esophagus using endoscopic submucosal dissection. It is a multicenter prospective registry~     among 7 centers including all consecutive patients with early Barrett's neoplasia of 15 mm or~     more in size treated by endoscopic submucosal dissection.~   "
75165|NCT02583074|"~     Primary cranial-cervical dystonia is managed mainly by repeated botulinum toxin~     injections.This study is to establish whether subthalamic nucleus neurostimulation could~     improve symptoms in patients not adequately responding to chemodenervation or oral drug~     treatment. Investigators compared this surgical treatment with sham stimulation in a~     randomized, controlled clinical trial.~   "
75166|NCT02583061|"~     In this prospective observational cohort study, women representing the full spectrum of~     gestational glucose tolerance status are undergoing longitudinal cardiometabolic~     characterization at regular intervals in the years after the index pregnancy.~   "
75167|NCT02583048|"~     This study will evaluate the safety, tolerability, and pharmacokinetics of the~     anti-tuberculosis (TB) drugs bedaquiline (BDQ) and delamanid (DLM), alone and in combination,~     among participants (with or without HIV co-infection) taking multidrug treatment for~     multidrug-resistant tuberculosis (MDR-TB) or rifampin-monoresistant TB (RR-TB).~   "
75168|NCT02583035|"~     There are no recommendations and few studies on the monitoring of fragile patients in the~     oncological treatment, both on the organizational arrangements on its interest in the~     prevention of functional deterioration of the patient and adaptation of the potential cancer~     treatment.~      The oncogériatrique evaluation being time-consuming, requiring the movement of these more or~     less frail elderly patients, it seems difficult to envisage repeated and systematic~     standardized geriatric assessments during cancer treatment. Geriatric fragility can be~     detected by telephone. Craven et al. has already assessed the telephone follow-up by a nurse~     in patients treated for cancer, but with the aim to detect toxicities of cancer treatment,~     patients are not very old (mean age 64.8 years).~      External evaluation by the nurse coordinator of UCOG (Coordination Unit in geriatric~     oncology) not knowing the patients included avoids bias of subjectivity in the interrogation.~      However the telephone monitoring, with the aim to evaluate the evolution of geriatric~     frailty, has not been specifically studied in the elderly population treated for cancer,~     while taking oncology load.~      The investigators wish to study the feasibility and validity of telephone follow-up which~     could eventually be used routinely to identify patients requiring further medical~     consultation oncogériatrique.~   "
75169|NCT02583022|"~     The study is a Phase II, single center, randomized, open-label, placebo-controlled study in~     male and female subjects, aged ≥ 20 years with mild to moderate atopic dermatitis. All~     subjects will receive BID topical applications of PAC-14028 cream or vehicle or Elidel cream~     for up to 4 weeks.~   "
75170|NCT02583009|"~     This clinical study is to determine the optimum dose of PAC-14028 cream in a therapeutic~     confirmatory clinical study by evaluating the safety and therapeutic equivalence of PAC-14028~     cream 0.1%, 0.3% and 1.0% in patients with rosacea.~   "
75171|NCT02582996|"~     National clinical trials, phase III, randomized, open, parallel, study of superiority, in~     which three hundred thirty-six (336) participants of both sexes, aged between 18 and 65 years~     will be randomly allocated to one of two treatment groups. The Group 01 will use Cefalium®~     and group 02 will use Tylenol®.~   "
75172|NCT02582983|"~     This study assessed the safety and tolerability of enfuvirtide in participants with advanced~     HIV genotype 1 (HIV-1) disease. Eligible participants who failed treatment with regimens~     containing at least one product from each anti-retroviral class, or had experienced~     intolerance to previous anti-retroviral regimens received enfuvirtide, 90 milligrams (mg)~     subcutaneously (SC) twice daily (BID) as long as there were no enfuvirtide related treatment~     limiting toxicities and participants benefited from study treatment as per investigator's~     discretion. The anticipated time on study treatment was based on the commercial availability~     of enfuvirtide in Thailand, and the target sample size was 30 individuals.~   "
75173|NCT02582970|"~     This expanded access study will assess the efficacy and safety of intravenous (IV)~     bevacizumab in combination with chemotherapy regimens as first-line treatment of metastatic~     cancer of the colon or rectum. The anticipated median time on study treatment is~     approximately 10 months, and the target sample size is 40 individuals.~   "
75175|NCT02582944|"~     Despite technological advancements directed towards the diagnosis of peripheral pulmonary~     lesions, an optimal approach has yet to be designed. The potential advantages of catheter~     based techniques include the ability to utilize instruments smaller than the diameter of a~     conventional bronchoscope, thereby allowing better access to the lung periphery. The~     drawbacks of a catheter based approach include the relative inability to steer a conventional~     catheter, and the inability to perform direct visualization and airway inspection through a~     conventional catheter. This study will evaluate a novel steerable catheter system with~     optical capabilities and pair this with electromagnetic navigation bronchoscopy to biopsy~     peripheral pulmonary lesions.~   "
75176|NCT02582931|"~     The investigators propose to evaluate the feasibility, safety, and preliminary efficacy of~     delivering online, adaptive magnetic resonance imaging (MRI)-guided and gated stereotactic~     body radiation therapy for patients with recurrent or metastatic ovarian cancer on a novel,~     integrated Co-60 MRI treatment machine. To best assess this technology, the investigators~     will focus on patients that have no more than three sites of progressive disease within the~     central thorax, liver, and/or non-liver abdominopelvis to receive adaptive, MRI-guided and~     gated SBRT with MRI simulation. Patients will be treated in five fractions over one to two~     weeks. By adhering to strict normal tissue constraints, expected toxicity will be within the~     current standard of care but will allow adaptation based on daily anatomic changes. The~     prescription dose will be determined based on hard normal tissue constraints, and capped at~     10Gy per fraction. Although the long term goal will be to achieve improved local control and~     disease-free survival with reduced toxicity, the present study will be driven by the short~     term goal of demonstrating the feasibility of this novel treatment approach for recurrent or~     metastatic ovarian cancer.~   "
75177|NCT02582918|"~     Project 5 of the Texas HCC Consortium (THCCC) is a comparative effectiveness pragmatic~     randomized control trial (RCT) of outreach strategies to increase hepatocellular cancer (HCC)~     surveillance process completion among a socioeconomically and racially diverse cohort of~     Texans with cirrhosis. Through this project the investigators will implement and evaluate~     system-level mailed outreach interventions to identity at-risk patients with cirrhosis,~     promote HCC surveillance, and ensure timely follow-up of tests at UT Southwestern (UTSW)~     Medical Center, Parkland Health and Hospital System (PHHS), and the Houston Veterans Affairs~     (VA) Medical Center. The study population will include adult patients with documented or~     unrecognized cirrhosis and at least one outpatient clinic visit in year prior to~     randomization. Patients will be identified using an EMR-enabled case identification~     algorithm. The investigators will randomize 3000 patients (1500 per arm) identified by this~     algorithm to: usual care, with opportunistic visit-based HCC surveillance (Group 1); or,~     mailed HCC surveillance outreach with patient education and patient navigation services~     (Group 2).~   "
75178|NCT02582905|"~     Preclinical and clinical data as well as mechanistic justification have been presented~     suggesting citicoline and pregnenolone are each promising treatments for alcohol use in BPD.~     Both appear to have favorable side effect profiles and no known drug-drug interactions. Thus,~     they have the potential to be safely used in a dual diagnosis population already taking other~     medications. A 12-week, randomized, double-blind, parallel-group, placebo-controlled adaptive~     design study of citicoline and pregnenolone is proposed in 199 persons with alcohol use~     disorder and bipolar I or II disorder or schizoaffective disorder (bipolar type). The primary~     aim will be to assess change in alcohol use. Biomarkers of alcohol use, alcohol craving, mood~     and cognition will also be assessed. Relationships between neurosteroid and choline levels~     and the outcome measures will be explored.~   "
75179|NCT02582892|"~     Vitamin D plays an essential role in calcium homeostasis and is critical for bone formation~     and remodeling.~   "
75180|NCT02582879|"~     The purpose of the InformCLL Registry is to characterize and describe treatment patterns for~     those initiating treatment with approved oral kinase inhibitors, BCL-2 inhibitors and other~     approved anti-CLL /SLL therapies/regimens. This study also evaluates association of treatment~     patterns with patient characteristics, healthcare resource utilization and patient reported~     Health related Quality of Life (HRQoL).~   "
75181|NCT02582866|"~     Study is conducted to evaluate the long-term safety and tolerability of lacosamide (LCM) in~     patients receiving LCM in SP0994 [NCT01465997]. The study will enable collection of~     additional monotherapy safety data, and will facilitate access to treatment until commercial~     availability for monotherapy use.~   "
75182|NCT02582853|"~     Guillain- Barré syndrome (GBS) is an acute inflammatory demyelinating polyneuropathy (AIDP)~     that often is triggered by an infection. GBS is characterized by progressing weakness and~     numbness and loss of tendon of reflexes. It can also include tingling sensation in the legs~     and arms. These symptoms occur due to an autoimmune attack on the myelin resulting in~     demyelination.~      The diagnosis is given by electrophysiological examination and clinical presentation.~      GBS is treated with intravenous immunoglobulin (IVIG) and plasma exchange (PE). Both~     treatments are equally effective. Most patients recover completely, while others must ease~     symptoms and reduce the duration of illness by several treatments.~      The purpose of this study is to define if patients with GBS have higher concentrations of~     sCD163 in their cerebrospinal fluid and serum compared with symptomatic control subjects.~     Furthermore it is to define if the concentrations of sCD163 reduces after treatment.~   "
75183|NCT02582840|"~     This randomized, single-blind, 3 arm, parallel group, placebo controlled PK/PD study will~     enrol 30 Japanese male and female patients with T1DM and age 18 to 65 years, with inadequate~     glycemic control on insulin defined as HbA1c ≥ 7.0% and ≤ 10.0% at screening visit.~     lacebo-controlled design. Patients will be randomized in a 1:1:1 ratio into one of the 3~     single-blinded treatment arms; dapagliflozin 5 mg, dapagliflozin 10 mg or placebo. CSII user~     are excluded.~   "
75215|NCT02582424|"~     This will be an 8 week multicenter, randomized, double-blind, placebo controlled trial.~   "
75217|NCT02582398|"~     This study aims to assess differences in monoamine oxidase A (MAO-A) distribution in the~     brain between seasonal affective disorder patients and healthy controls using positron~     emission tomography. In addition the investigators aim to demonstrate the impact of light~     therapy on MAO-A distribution~      In addition, a pilot study and a sub-study in healthy controls were performed~   "
76915|NCT02560233|"~     The overall goal of the outlined study is to establish a Real-Time (RT) functional Magnetic~     Resonance Imaging (fMRI) Neurofeedback (NF) (RT-fMRI-NF) protocol aiming at modulating~     neural, endocrine, and subjective reactivity to psychosocial stress.~   "
75184|NCT02582827|"~     The primary objective of study CA601.2 is to determine the maximum tolerated dose (MTD) or~     recommended phase 2 dose (RP2D) of ABI-011 when administered by intravenous (IV) infusion on~     Days 1, 8, and 15, followed by a week of rest, in patients with advanced solid tumor~     malignancies or lymphomas. The MTD will be determined using a standard 3+3 design. The~     secondary objectives are to evaluate the safety and toxicity profile, to evaluate the plasma~     pharmacokinetics (PK), to assess the biological activity and pharmacodynamics, and to make a~     preliminary assessment of tumor response in patients with advanced solid tumors or lymphomas.~     The exploratory objectives are to determine the genomic and proteomic profile of patients'~     tumors to identify gene mutations, gene amplifications, levels of protein expression, and~     pinpoint oncoproteins. Correlations between genomic/proteomic profiles and efficacy outcomes~     will be assessed and principal metabolites of ABI-011 will be determined, if possible.~      Approximately 45-60 patients will be treated to determine dose limiting toxicities (DLTs),~     the MTD, and/or RP2D of ABI-011. Once the RP2D is identified, expansion of this cohort (up to~     10 patients) will occur.~   "
75185|NCT02582814|"~     This study will enroll eligible subjects into a long-term safety study (Part B).~      Japanese male and female patients with T1DM and age 18 to 75 years, with inadequate glycemic~     control on insulin defined as HbA1c ≥ 7.5% and ≤ 10.5% at screening visit. As a condition of~     enrollment, subjects must be on a total daily insulin dose of ≥ 0.3 U/kg/day for at least 3~     months prior to the screening visit. The study design of Part B is a randomized, open-label,~     2 arm, parallel-group design. 140 Japanese subjects in total will be randomized in a 1:1~     ratio into one of the two treatment arms; dapagliflozin 5 mg or dapagliflozin 10 mg.~   "
75186|NCT02582801|"~     18F-Alfatide Ⅱ PET/CT in breast cancer patients~   "
75187|NCT02582788|"~     The current clinical guidelines for management of atopic dermatitis now recommend bleach~     baths. This requires simply the addition of regular household bleach to twice-weekly baths.~     At the Mayo Clinic, dilute acetic acid (vinegar) has been recommended for decades in wet~     wraps to treat patients hospitalized for their atopic dermatitis. However, this practice has~     not been widely adopted in the pediatric dermatology community. Will the use of dilute acetic~     acid (vinegar) in twice weekly baths help manage atopic dermatitis in pediatric patients as~     well as, or better than, the current accepted guidelines?~   "
75188|NCT02582775|"~     This is a single-institution, phase II study to determine the event-free survival at 1 year~     post allogeneic transplant and serial mesenchymal stem cell (MSC) infusions from a related~     donor (HLA identical, mismatched or haploidentical) or matched unrelated donor for the~     biochemical correction of severe epidermolysis bullosa (EB).~   "
75189|NCT02582762|"~     Nail surface abnormalities is any conditions that affect the nail matrix or nail bed which~     cause nail plates grow defectively. Common nail surface abnormalities are pitting nails,~     longitudinal ridging, and transverse ridging/Beau's line. Aging nails usually have nail~     surface abnormalities as well.~      Nail gels are artificial nails used widely for aesthetic purposes. Although, their cosmetic~     use is increasing with day by day, their usefulness in conditions such as nail biting,~     brittle nails, and ingrown toe nails has been reported. Moreover, a previous study reported~     the benefits of nail gels in terms of improving nail surface abnormalities like pitting~     nails, trachyonychia, and onychoschizia.~      This study was conducted to evaluate the efficacy of nail gel containing Glycerin which has~     humectant effect and Artemisia Abrotanum extract which has anti-fungal/bacterial activities~     in finger nail surface abnormalities.~   "
75190|NCT02582749|"~     Newly diagnosed metastatic prostate cancer subjects with bone metastases will be accrued to~     this stratified randomized 2-arm Phase II trial. Subjects will be randomized 1:2 to ADT or~     ADT with Radium-223 dichloride respectively.~   "
75191|NCT02582736|"~     The purpose of this study is to determine whether the use of atypical antipsychotic~     medication increases the risk of hospitalization for a hyperglycemic emergency.~      The investigators will carry out separate population-based cohort studies using~     administrative health databases in eight jurisdictions in Canada and the UK. Cohort entry~     will be defined by the initiation of a new antipsychotic medication. Follow-up will continue~     until hospitalization for a hyperglycemic emergency or the end of 365 days. The results from~     the separate sites will be combined to provide an overall assessment of the risk of~     hyperglycemic emergencies among new users of various antipsychotic drugs.~   "
75192|NCT02582723|"~     A double-blind, randomised crossover design will be employed with three experimental~     conditions; High protein/high fat hard cheese, high protein/low fat hard cheese, and low~     protein/high fat creme cheese served at least 7 days apart. After having successfully~     completed screening procedures, eligible participants will be invited for three separate test~     days. The test days should be performed at least 7 days apart; however for logistical reasons~     4 days can be accepted. On the test days, the products will be provided in a randomized~     order, and subjective appetite ratings will be measured every 30 minutes for the following 3~     hours. Subsequent energy intake will be measured by an ad libitum meal 3 hours following~     serving of the breakfast meal.~   "
75193|NCT02582710|"~     Determining whether treatment with an optimized formulation of omega 3 for 6 weeks causes a~     40% decrease in the average concentration of total microparticles (MPs) in the atheromatous~     plaque.~   "
75194|NCT02582697|"~     The purpose of this study is to determine whether accelerated BEP chemotherapy is more~     effective than standard BEP chemotherapy in males with intermediate and poor-risk metastatic~     germ cell tumours.~   "
75195|NCT02582684|"~     This study was done to see if the combination of two anti-HIV medicines, dolutegravir (DTG,~     Tivicay) and lamivudine (3TC, Epivir) taken once a day, provide a safe, effective, and~     well-tolerated treatment for HIV. DTG is a type of HIV medicine called an integrase~     inhibitor; 3TC is a type of HIV medicine called a reverse transcriptase inhibitor. DTG works~     by blocking integrase and 3TC works by blocking reverse transcriptase, two HIV proteins~     (enzymes). This prevents HIV from multiplying and lowers the viral load (amount of HIV in the~     blood). Both DTG and 3TC are currently part of Food and Drug Administration (FDA) recommended~     regimens along with a third active drug. Since some HIV medicines have side effects and are~     costly, there is interest in whether HIV can be successfully controlled with fewer than three~     HIV drugs.~   "
75196|NCT02582671|"~     This study seeks to determine the effectiveness of the interferon-free ABBVIE REGIMEN ± RBV~     in chronic hepatitis C virus infected participants across Ireland.~   "
75200|NCT02582619|"~     Spinal cord injury often results in complete or partial loss of functioning of the upper and~     or lower limbs, leading to the affected individual experiencing difficulties in performing~     activities of daily living. This in turn results in reduced participation in social,~     religious, recreational and economic activities (employment). Globally, there is a low~     employment rate (11-67%) amongst PLWSCI. In South Africa, according to Statistics South~     Africa, the unemployment rate of people with disabilities is estimated to be 25.2%. However,~     there is no information available on employment amongst PLWSCI in South Africa.~      Furthermore, there is insufficient knowledge related to SCI in South Africa to enable a model~     to be developed and implemented. Data on the current SCI rehabilitation practices (with~     specific reference to vocational rehabilitation); employment status and factors (both~     personal and environmental); barriers and facilitators of employment amongst PLWSCI is~     limited. This information is needed to develop a return to work model for individuals with~     SCI in South Africa.~      In South Africa, a legal framework exists that promotes the employment as well as assistance~     of people with disabilities in the workplace, such as: the Constitution of Republic of South~     Africa, 1996; the Employment Equity Act (EEA), 1998; the Promotion of Equality and Prevention~     of Unfair Discrimination Act (PEPUDA), 2000; Labour Relations Act (LRA), 1995; Skills~     Development Act (SDA), 1998; Public Service Act (PSA), 1994; Basic Conditions of Employment~     Act (BCEA), 1997 and the Integrated National Disability Strategy (2000). However,~     rehabilitation interventions provided in rehabilitation institutions are mainly medical, with~     limited attempts to prepare those with SCI to return to gainful employment. There is~     therefore a need for a well-coordinated, multi-sectorial, multi-disciplinary and~     multi-factorial rehabilitation intervention that will promote the employment of PLWSCI in~     South Africa.~   "
75201|NCT02582606|"~     In this study investigators will compare the health effect of two different meal patterns. In~     one, participants will consume food according to an 'irregular meal pattern' (minimum 3~     meals, maximum 9 meals per day) and in the other 'regular meal pattern' (6 meals per day) for~     two weeks. The energy requirement of the participants will be calculated to maintain body~     weight during the study. Participants will be provided with all the food to be consumed~     during the study.~      Initially, interested individuals will attend a screening visit in which they will complete~     questionnaires on medical health, eating habits and physical activity. Height, weight and~     waist circumference will be measured at this visit. Thereafter, participants will be assigned~     to a 2-week period following one of the two meal-patterns. There will be a 2-week period~     between the two interventions when they will consume their normal diet and at the end of~     this, participants will undertake the next meal pattern. During the two phases participants~     will be asked to wear an armband (which detects movement and measures heat loss), to assess~     their energy expenditure and an interstitial glucose monitoring device will be worn for seven~     days. Before and after each 2-week intervention, participants will come to the laboratory for~     a mixed-meal tolerance test. Blood samples will be obtained before and for 3hrs after eating~     to evaluate the health effects of the meal patterns. Energy expenditure will be measured by~     ventilated-hood indirect calorimetry and the armband device. At the end of the 3hr post~     prandial period, participants will be offered an ad libitum pasta lunch and be asked to eat~     until they feel comfortably full.~      During each of the 2-week periods, participants will be asked to record their food intake and~     record their appetite sensations on specific days.~   "
75202|NCT02582593|"~     Changes in mood and cognition are common in older adulthood. Some studies have suggested that~     transcranial application of near-infrared (NIR) light may have enhancing effects on cognitive~     and mood status in young adults and individuals with traumatic brain injury. This effect has~     not been examined in older adults. This study will involve a randomized sham-controlled trial~     to learn whether NIR stimulation improves cognition and mood in older adults, relative to~     sham treated controls.~   "
75203|NCT02582580|"~     Perineal trauma during childbirth is an important etiological factor of various undesirable~     complications to women's health, with emphasis on pelvic floor dysfunction. Thus, methods~     that preserve the perineal integrity have been a challenge to practices among health~     professionals working in the gravid-puerperal cycle assistance. Despite the remarkable~     importance of beneficial effects of pelvic floor preparation prior to vaginal birth on~     prevention of perineal trauma, there are few studies in the literature that point which is~     the best method to be used to reduce the chances of perineal lesions. Therefore, there is~     need for more studies to compare existing methods. The objective this present study is to~     compare the effects of perineal massage, the vaginal dilator and training of the muscles of~     the pelvic floor to prepare the pelvic floor for vaginal birth on perineal integrity of~     primiparous. Primigravidae women are selected over 18 years, from the 32th gestational week~     and wishing to have a vaginal birth. Women will be randomly allocated into 3 groups: perineal~     massage, vaginal dilator and pelvic floor muscles training and should practice the technique~     from the 34th week of pregnancy until the time of delivery. All the women will be subject to~     clinical evaluation, functional assessment of pelvic floor and perineal integrity assessment~     prior to the beginning of the practice of the technique and between 45 and 60 days after~     childbirth.~   "
75204|NCT02582567|"~     The main objective of this project is to assess the effects of a novel and supervised~     exercise intervention in overweight pregnant and their newborn.~      Methods/Design: The present study is a Randomized Controlled Trial. Sixty overweight pregnant~     interested in participate in the intervention program will be randomly assigned to either~     exercise (3 sessions/week), or to usual care (control) group (30 pregnant per group). The~     primary outcome measures are maternal weight gain, and maternal and neonatal glycaemic~     profile. Secondary outcomes measure are: i) body composition; ii) dietary patterns; iii)~     physical fitness; iv) objectively measured physical activity and sedentary behaviour; v)~     sleep quality; vi) mental health, quality of life and positive health; vii) haematology and~     biochemical analysis; viii) oxidative stress; ix) pro- and anti-inflammatory markers; x) bone~     health biomarkers; xi) adiposity-related proteins expression. The data will be analysed on an~     intention-to-treat basis and per protocol.~   "
75216|NCT02582411|"~     Some of the most prevalent eye diseases such as age-related macular degeneration, glaucoma~     and diabetic retinopathy are associated with ocular perfusion abnormalities. Currently, there~     is no gold-standard method for the measurement of ocular blood flow available. Laser speckle~     flowgraphy is a promising technique for the two-dimensional assessment of ocular blood flow~     in humans. So far the technique has, however, been only gained widespread use in Japan. The~     experience in Caucasian subjects is very limited. In a Japanese population it was shown that~     mean blur rate, a measure of chorioretinal blood velocity, decreases with age. This is of~     relevance, because an age-related decline in ocular blood flow may partially explain the~     age-dependence of ocular vascular disease. The present study investigates this age-dependence~     in healthy subjects. In addition, the investigators investigate in a sub-group of this~     population whether relative flow volume (RFV), a novel index of blood flow in the human~     retina derived from laser speckle flowgraphy is associated with retinal blood flow as~     assessed with bi-directional Doppler Optical Coherence Tomography (DOCT).~   "
75205|NCT02582554|"~     Good nutrition is necessary for optimal growth and development in young children. Nutrition~     risk screening can identify those at risk and to refer them for assessment and treatment. The~     NutriSTEP® (Nutrition Risk Screening for Every Preschooler) questionnaires are 17-item,~     community-based, parent-administered questionnaires for identifying nutritional risk in~     toddlers (18-35 months) and preschoolers (3-5 years). Internet versions are available on the~     Dietitians of Canada website as part of a Nutri-eSTEP online tool. NutriSTEP® is mandated for~     use in Ontario and New Brunswick and is also used in other provinces. NutriSTEP® has been~     implemented in Canadian jurisdictions and in research settings. Many health care~     practitioners, mainly registered dietitians, and policy makers, are asking for evidence that~     NutriSTEP® makes a difference and this project is proposed to show that nutrition screening~     with NutriSTEP® with its accompanying nutrition education resources will increase knowledge~     and change nutrition-related practices by parents of preschoolers.~      This research will be a randomized control trial with more than 150 parents/caregivers of~     toddlers and preschoolers. The treatment group will receive screening with the Nutri-eSTEP~     version of NutriSTEP® and will receive the accompanying nutrition education messages and~     links to resources. A control group will receive the screening treatment at the end of a 12~     week intervention. At the beginning and end of the 12 week period, parents/caregivers will~     fill out questionnaires on parental nutrition knowledge and nutrition-related behaviour~     (including attitudes and intentions).~      This will be the first study of nutrition risk screening with NutriSTEP® to determine if the~     screening process, along with its accompanying nutrition education messages makes a~     difference.~   "
75206|NCT02582541|"~     Endoscopic radiofrequency ablation (RFA) is a new palliation therapy for malignant bile duct~     obstruction. It delivers a high amount of thermal energy to target tissue and may prolong the~     duration of stent patency. RFA has showed promising results for malignant bile duct~     obstruction and increasing the duration of stent patency. The aim of our study was to~     evaluate the feasibility and safety of endoscopic RFA for the treatment of bile duct~     obstructions, and to compare the efficacy of Endoscopic biliary RFA with the addition of~     self-expanding metal stents (SEMS) to SEMS alone in a randomized controlled trial.~   "
75207|NCT02582528|"~     The primary aim of the project is to test the effectiveness of a cognitive remediation~     treatment (CRT) program, My Brain Solutions (MBS), in addition to motivational interviewing~     (MI) in improving cognition and functional outcome of individuals at risk of SMI. An active~     control treatment consisting of CRT alone will be used. Hypotheses: 1. Both study groups will~     have improvement in cognition at the end of treatment; 2. CRT+MI group will have increased~     treatment adherence and superior improvements in cognition at the end of treatment and 12~     months post baseline compared to the CRT only group; Secondary Hypothesis: 3. Improved~     cognition will be associated with improved functional outcome.~   "
75208|NCT02582515|"~     Expert reviews and practice parameter papers recommend behavior therapy as a first-line~     intervention for youth with chronic tic disorders (CTDs) with mild-to-moderate tic severity.~     Although behavior therapies like the Comprehensive Behavioral Intervention for Tics (CBIT)~     are efficacious in reducing tic symptom severity, only 50% of individuals exhibit a positive~     treatment response. Thus, there is a clear need to identify strategies to improve treatment~     response and/or accelerate therapeutic gains .~      The primary ingredient of CBIT is habit reversal training (HRT), which utilizes both~     extinction and associative learning. Psychosocial treatments relying on these learning~     mechanisms have demonstrated an enhanced and/or expedited therapeutic benefit when augmented~     with d-cycloserine (DCS). This feasibility study will examine the incremental efficacy of~     HRT+DCS over HRT+placebo for tics targeted with HRT. Eligibility criteria will parallel the~     child CBIT trial for generalizability and comparability, with the addition of DCS~     contraindications as exclusionary criteria. Parents and youth will complete a battery of~     clinical assessments to ascertain tic symptoms severity and co-occurring psychiatric~     conditions. Afterwards, participants will be randomly assigned to receive either HRT+DCS or~     HRT+placebo. Instead of a full course of HRT (8 sessions over 10 weeks), a more efficient~     Quick-Win/Fast-Fail trial design will be used that includes a truncated HRT protocol to~     provide results in a more timely fashion. As a result of this trial design, the primary~     outcome of this study will focus on the reduction of bothersome tic severity for those~     targeted in treatment rather than global severity reductions.~   "
75209|NCT02582502|"~     The purpose of this study is to examine the role of Hyperbaric Oxygen Therapy (HBOT) in~     improving neurological function in patients who are 6 to 36 months post ischemic stroke.~   "
75210|NCT02582489|"~     The proposed research study aims to evaluate the effects of autologous bone marrow aspirate~     concentrate (BMAC) on the development and progression of osteoarthritis (OA) in patients~     undergoing meniscectomy. This prospective, randomized, double-blind clinical trial will~     compare patient-reported outcomes, specifically IKDC scores between patients who receive BMAC~     post-meniscectomy and those who receive a saline control injection. The study will also~     compare physical examination, MRI, radiographs, and synovial fluid analysis. Our hypothesis~     is that those who receive the autologous BMAC injection after the procedure will have better~     outcomes than those who do not.~   "
75211|NCT02582476|"~     This is a randomised, double-blind, placebo-controlled phase II clinical trial with a~     cross-over design to investigate the efficacy of bumetanide in patients with hypokalemic~     periodic paralysis (HypoPP).~      The aim is to assess the efficacy of bumetanide in reducing severity and duration of a focal~     attack of weakness in a hand muscle.~      Twelve participants will be recruited.~   "
75212|NCT02582463|"~     The purpose of this study is to develop a prediction-tool, the Medicines Optimisation~     Assessment Tool (MOAT), to assist hospital pharmacists identify patients at highest risk of~     preventable medication related problems (MRPs). This has the potential to permit pharmacists~     to identify and focus on the small number of patients (approximately 6%) who are likely to~     experience a significant MRP while in hospital.~   "
75213|NCT02582450|"~     Research project for validation of a questionnaire on compliance to treatment in patients~     with hemophilia. It is intended to validate the American VERITAS-PRO scale according to the~     international methodology validation questionnaires: reverse translation, according to~     intersubject patients, psychometric validation and reliability analysis with large sample of~     patients.~   "
75214|NCT02582437|"~     The purpose of this study is to find difference in Minimum Alveolar Concentration(MAC) for~     maintaining Bispectral Index (BIS) below 50 between chronic opioid users and opioid naive~     patients.~   "
75218|NCT02582385|"~     The investigators aim at exploring the differential/topographical in-situ expression of~     cytokines in the central nervous system (CNS) of patients who died with amyotrophic lateral~     sclerosis (ALS), using archived histopathology slides and residual paraffin blocks from~     autopsied cases. Previous studies from the investigators and other groups showed that~     inflammatory cytokines are implicated in several neurological affections, particularly~     neurodegenerative conditions. However, in-situ cytokine expression has never been studied so~     far in ALS. The investigators wanted to see if these neuro-mediators are involved in the~     neuromolecular chain/cascade underlying ALS.~   "
75219|NCT02582372|"~     Dexmedetomidine, highly selective agonist for alpha-2 receptors, enhances the sensory and~     motor block with prolonged postoperative analgesia without hemodynamic compromise.~      OBJECTIVE: To evaluate effects of dexmedetomidine vs fentanyl with hyperbaric bupivacaine~     spinal anesthesia for lower abdominal surgeries.~      METHODS: double-blind, randomized, American Society Anesthesiologist classification (ASA) : I~     - II, 18-65 years. F group (23 patients) received 25 mcg fentanyl, Group D (27 patients), 10~     mcg dexmedetomidine with 12.5 mg hyperbaric bupivacaine . 0,02mgrs morphine / kg~     intravenously if EVA≥4was administered in postoperative period. Hemodynamic variables and O2~     saturation intraoperatively was recorded, EVA every 4 hours, side effects, sensory block,~     motor, sedation and peripheral neurological manifestations of toxicity.~   "
75220|NCT02582359|"~     This research study is evaluating drugs called Millennium 9708 (referred to as MLN9708) in~     combination with standard therapy for acute myeloid leukemia (AML) consisting of daunorubicin~     and cytarabine as a possible treatment for the patient AML.~   "
75221|NCT02582346|"~     This project aims at assessing two MRI acquisition methods, neurography and tractography, for~     the visualization of pelvic nerves. The goal is to optimize both methods and to test them on~     a pool of volunteers to assess if nerves can be delineated, so as to provide an~     individualized mapping of nerves to surgeons before an intervention and avoid postoperative~     complications.~   "
75222|NCT02582333|"~     Background:~      Taiwan is one of the area with the highest prevalence of chronic hepatitis B (CHB), and many~     patients die of hepatitis B virus (HBV)-related cirrhosis or liver cancer that have been the~     leading causes of death in Taiwan for many years. For effectively treating CHB, antiviral~     therapy for CHB has been reimbursed by the National Health Insurance in Taiwan since 1998,~     and nucleos(t)ide analogues (NAs) can be used for patients with active hepatitis B and high~     viral load in a maximum duration of three years. However, there is a significant proportion~     of patients suffering from hepatitis B recurrence after discontinuation of NA therapy, and~     hepatitis B recurrence may result in liver cirrhosis and liver cancer. To the best of current~     knowledge, in what conditions that the NA therapy can be successfully discontinued without~     hepatitis recurrence remain largely unclear. Therefore, this study is designed to evaluate~     the clinical and virological changes of CHB patients after stopping NA therapy, and finding~     the prognostic indicators may be an important basis for stopping NA therapy in CHB patients~     in the future.~      Objectives:~        1. To access the clinical and virological changes after stopping NA therapy~        2. To determine important prognostic indicators for stopping NA therapy~      Methods:~      In this prospective cohort study, the investigators plan to recruit CHB patients who are~     indicated for stopping NA therapy in the outpatient clinics according to the inclusion and~     exclusion criteria of this study, and clinical and virological data will be collected during~     routine clinic visits after stopping NA therapy. Prognostic factors will be analyzed~     according the following data:~        1. Patient characteristics: including age, sex, height, weight, waist circumference,~          history of alcohol drinking, antiviral therapy history, hepatitis history, and drug~          history.~        2. Blood tests: During routine clinic visits and blood tests every 12 weeks or at hepatitis~          flare in the first 2 years after stopping NA therapy, liver function and virological~          status tests will be conducted for analysis.~   "
75223|NCT02582320|"~     This is a retrospective observational study aimed at describing the characteristics and~     outcome of CLL patients included in the NPP in Italy in a period of time ranging from the~     start of the NPP until November, 30th 2014. A longitudinal survey will be carried out by~     collecting data of patients who received at least 1 dose of Ibrutinib. All patients will be~     observed for at least 12 months from the treatment start.~   "
75224|NCT02582307|"~     There is ample evidence that pain in children is under recognized and under treated. This is~     especially true for acute abdominal pain, a common complaint in the paediatric emergency~     department. Clinicians often fear that analgesia will obscure the diagnosis of a potentially~     surgical condition. As a result, acute abdominal pain goes untreated in many children, as~     there is no standard of care. Hyoscine N-butylbromide (Buscopan) has been used successfully~     in adults and children for pain associated with urinary tract infections and kidney stones~     for over 60 years. However, no study has explored its usefulness in relieving acute abdominal~     pain in children. The objectives of this study are to investigate to what degree Buscopan is~     effective in relieving abdominal pain in children compared to acetaminophen.~   "
75225|NCT02582294|"~     Fabry's disease is a progressive systemic disease X-linked which combines neurological~     (Fabry's pain crises), dermatologic (angiokeratomas), renal (renal failure), cardiovascular~     (hypertrophic cardiomyopathy, valvular disease, conduction disorder, coronary heart disease)~     and cerebral vascular (stroke) symptoms .~      It is a glycosphingolipid metabolism disorder due to deficient or absent activity of the~     alpha-galactosidase A, causing accumulation of globotriaosylceramide in the lysosomes.~      The incidence is estimated being 1/40 000. Some patients suffering from Fabry's disease today~     are of childbearing age and their multidisciplinary care (by neurologists, obstetricians and~     anesthetists) raises several questions.~      About the anesthetic, the question of epidural block is debated in patients with neurological~     diseases and recommendations are not unequivocal.~      Indeed one of the problems of the management in those conditions is the potential worsening~     of the disease because of the anesthetic procedure. In addition, the possibility of an~     antiplatelet and / or an anticoagulant treatment in these patients may also contre-indicate~     an epidural block.~      The rate of epidural block achieved in patients with Fabry's disease is not currently known.~     Moreover, only sparse data on pregnancy outcomes in these patients are reported.~   "
75226|NCT02582281|"~     The non touch technique is a modification of the traditional intrauterine device insertion~     technique. It abolishes the use of Allis and uterine sounding.~   "
75227|NCT02582268|"~     A previous trial performed by our research team, in order to reduce the pain associated with~     intrauterine device insertion, compared the novel technique of IUD insertion under the~     guidance of the trans-abdominal sonography to the traditional method of IUD insertion. It~     came up with the conclusion that the TAS guided IUD insertion is significantly lower in pain~     score and time taken for insertion, when compared with the traditional method. In this study~     our researchers aim to abolish the distracting effect of the technician and the TAS probe~     (which might have interfered with previous results).~   "
75228|NCT02582255|"~     A Phase 4 study to evaluate the safety and immunogenicity of monovalent oral polio vaccine~     type 2 in healthy IPV-vaccinated children aged 1 to 5 years in Lithuania.~   "
75230|NCT02582229|"~     Surgery is the only effective treatment for morbid obesity and can be divided into~     restrictive surgeries (Lap Band and Sleeve gastrectomy), malabsorptive surgeries (Biliary~     pancreatic deviation and duodenal switch) or a combination of both (RYGBP).~      This later technique is the most common and most effective surgical procedure performed~     worldwide and has been processed to be an effective treatment of morbid obesity and its~     complications, achieving excess weight loss of 65 to 80 % ; 1-2 years after surgery (1,2).~      Vertical gastric plication is a novel surgical approach for reducing the stomach capacity.~     Anterior surface plication and greater curvature plication are variations of vertical gastric~     plication that reduce the gastric capacity through infolding of the anterior surface or~     greater curvature of the stomach, respectively. These approaches have been tested, with~     positive results (3,4).~      A transoral or endoluminal approach (ie, a procedure that requires no incision, because~     access is granted through the mouth) offers the potential for additional benefit to the~     patient, because the procedures continue to become more and more minimally invasive.~      Advances in endoluminal devices are now allowing clinicians the ability to begin exploring~     bariatric procedures performed via flexible endoscopy. Although these procedures may not be~     as effective as their surgical counterparts, these less-invasive options may relieve patients~     of the significant risks associated with surgery (5).~   "
75231|NCT02582216|"~     This study has two objectives. First, to introduce a new virtual reality method that~     incorporates the mechanisms used in mirror visual feedback through a three-dimensional (3D)~     augmented virtual reality system. Second, to evaluate the efficiency of this new method on a~     convenience sample of patients presenting with unresolved neuropathic pain (CRPS, PLP,~     plexopathy, stroke) who were not responding adequately to both pharmaceutical management and~     traditional mirror therapy.~   "
75232|NCT02582203|"~     The proposed study is a prospective, open-label, randomized, multi-center trial of~     ceftaroline versus vancomycin for the treatment of ABSSSI in patients documented or at risk~     for MRSA. Patients admitted to the Detroit Medical Center, Henry Ford Hospital, or St. John~     Medical Center in Detroit Michigan with a documented ABSSSI between April 2012 and November~     2015 will be evaluated for inclusion. Patients must present with at least 3 of the following~     local signs/symptoms: pain, tenderness, swelling erythema, warmth, drainage/discharge,~     induration, and lymph node swelling/tenderness. Patients will be randomized 1:1 ceftaroline~     or vancomycin with optional anaerobic and/or Gram-negative coverage. The assignment of study~     drug will follow a randomized list that was previously generated via a computerized random~     mix block generator (nQuery Advisor® 7.0) and available at each of the study sites. Patients~     will be randomized to ceftaroline intravenously at 600 mg infused over 1 hour every 12 hours~     for patients with normal renal function. Patients randomized to vancomycin will receive the~     standard 15 mg/kg dose based on total body weight infused over 1 hour q 12 hour, dose and~     interval adjusted based on creatinine clearance and via institution-specific pharmacy~     protocol to target serum trough concentrations of 10-20 mg/L within the first 72 hours.~     Outcomes measured in the Clinically Evaluable patient population include day two or three~     size reduction (percentage) and clinical response at end of therapy or discharge.~   "
75233|NCT02582190|"~     There is substantial evidence linking inflammation to the initiation and perpetuation of AF.~     Although the precise mechanism by which inflammation contributes to the development of AF~     remains unclear, it has been proposed that inflammation may lead to atrial myocarditis with~     subsequent electrical and structural changes involving both atrial myocytes and extracellular~     matrix, leading finally to initiation and maintenance of AF. The high incidence of AF in~     post-operative cardiac surgeries, a state of intense inflammatory process, points out this~     association. Similarly, in non operative AF, inflammation appears to play a prominent role in~     both etiology and maintenance of AF. Indeed an increase of inflammatory markers to both~     paroxysmal and persistent AF was shown by numerous studies.~   "
75234|NCT02582177|"~     To evaluate the no-inferiority of the ketoconazole20mg/g and betamethasone dipropionate 0.64~     mg/g association (Candicort®) cream or ointment versus clotrimazole 10mg and dexamethasone~     acetate 0.443 mg/g association (Baycuten N®) cream, general relief of signs and symptoms~     (erythema, maceration, peeling, blistering / papules / pustules, itching and burning /~     stinging) 06 (± 1) days after onset treatment.~   "
75235|NCT02582164|"~     Young children age 6 month to 6 years are often not able to cooperate for advanced OCT eye~     imaging. The purpose of this study is to investigate the use of a novel long-working distance~     swept source (SS) optical coherence tomography imaging system with fixation alignment for use~     first in young adults, older children, and then young children ages 6 months to 6 years. The~     investigator's future goal is to obtain important retinal and optic nerve information from~     OCT in clinic in these young children.~   "
75236|NCT02582151|"~     Neurogenic bladder patients may have symptoms of urinary frequency, urgency, urgency~     incontinence and voiding symptoms due to bladder dysfunction arising from their underlying~     neurologic condition. Current treatment options are effective for some patients, however many~     patients are not optimally managed due to modest efficacy or significant side effects. Second~     line therapies include intravesical onabotulinum toxin, however it is associated with a risk~     of urinary retention, and patients with neurologic disorders often are unable to perform self~     catheterize due to physical limitations. Sacral neuromodulation is associated with an~     undesirably high cost and potential complications in this population. The use of~     transcutaneous tibial nerve stimulation is an alternative form of neuromodulation, and it may~     have some potential benefits over percutaneous tibial nerve stimulation. While some~     preliminary studies have suggested it may be effective, there are no high quality randomized~     trials. This proposal is a 3 month, randomized, sham-controlled, clinical trial to evaluate~     the short term clinical efficacy of at home transcutaneous tibial nerve stimulation. Valid~     and reliable patient reported outcome measures, and objective measures of incontinence have~     been included as outcomes.~   "
75237|NCT02582138|"~     The SPRINTT study will evaluate the efficacy of a multicomponent intervention programme~     (physical activity, nutritional counselling/dietary intervention, and information and~     communications technology intervention) compared with a healthy aging lifestyle education~     programme on mobility disability, in non-disabled older people with physical frailty and~     sarcopenia.~   "
75238|NCT02582125|"~     The objective of the study is to investigate the safety and efficacy of ONO-4538 in subjects~     with stage IIIB/IV or recurrent non-small cell lung cancer unsuited to radical radiotherapy~     and resistant to a platinum-based chemotherapeutic regimen.~   "
75239|NCT02582112|"~     This prospective, double-blinded, randomized, controlled study was undertaken to evaluate~     whether warming IV fluids (37 oC) resulted in lower incidence of hypotension, less ephedrine~     and transfusion requirement and lower fluid consumption than use of room-temperature fluids~     (22 oC) in cesarean delivery patients undergoing spinal anesthesia.~   "
75240|NCT02582099|"~     Topical antibiotic therapy in patients with refractory sinusitis has been shown to improve~     symptoms, quality of life, and mucosal aspect. In pediatrics allergy clinic at Siriraj~     hospital since 2006 use Gentamicin nasal irrigation for chronic rhinosinusitis.There have~     been no prospective studies in gentamicin irrigation in chronic rhinosinusitis.~   "
75241|NCT02582086|"~     The aim of this study is to determine the safety and efficacy of a topical natural health~     product in comparison to placebo for the treatment of herpes labialis.~   "
75242|NCT02582073|"~     There is increasing evidence that the effectiveness of allergy immunotherapy to control~     symptoms of rhinoconjunctivitis is related to the cumulative dose of allergen or allergoid~     administered during a single regimen of subcutaneous (SC) injections or of sublingual~     administration. The current therapeutic dose regimen for Grass MATA MPL is a course of four~     injections of 300, 800, 2000 and 2000 SU (Standardized Units), administered at weekly~     intervals (cumulative dose 5100 SU). Two new cumulative doses of the Grass MATA MPL 10200 SU~     and 18200 SU are being developed to compare with the current dose. The study is designed to~     explore the benefit/risk of increasing the cumulative allergen dose of the Grass MATA MPL~     immunotherapy comparing these doses with the current dose of Grass MATA MPL, Grass MATA~     (without MPL) and placebo.~   "
75243|NCT02582060|"~     Currently dosing for prophylaxis is not individualized, and the general approach is to use a~     dose of 25-40 units/kg given 3 times per week or every other day. One of the issues with~     weight-based dosing is the possible over-treatment. This is likely due to the fact that~     laboratory tests are not sensitive enough at the low levels to support decision-making. The~     Thromboelastograph (TEG®) and Thromboelastometry (ROTEM®) are coagulation devices, which~     assess the dynamics of clot formation over time and have several characteristics which~     suggest they may provide important information for individualized prophylaxis treatment for~     our patients.~   "
75244|NCT02582047|"~     Previous studies have demonstrated the immunogenicity and safety of the co-administration of~     the trivalent inactivated influenza vaccine (IIV3) with the polysaccharide pneumococcal~     vaccine (PPV) or pneumococcal conjugate vaccine (PCV). However, there is no direct comparison~     study that evaluates the immunogenicity and safety of IIV3 given concomitantly with PCV13 or~     PPV23 in the elderly. This study is intended to compare the immunogenicity and safety of~     concomitant administration in the elderly subjects.~   "
75245|NCT02582034|"~     The purpose of this study is to determine whether a treatment with Therasphere which is~     optimized is more efficient compared to a standard treatment for patients suffering from~     hepatocellular carcinomas.~   "
75246|NCT02582021|"~     The Women's Ischemia Study Evaluation (WISE), a cohort study of over 1000 women, has made~     many contributions to the understanding of cardiovascular disease. A milestone acknowledged~     in the 2011 AHA Herrick Lecture is the role of Coronary Microvascular Dysfunction (CMD) in~     women with symptoms/signs of ischemia without obstructive coronary artery disease (CAD).~     While in 1996, CMD was considered an imaging artifact, in 2013, it is a widely accepted as~     a pathophysiologic process requiring systematic cohesive scientific pursuit. CMD is~     prevalent, associated with adverse clinical outcomes, poor quality of life and healthcare~     costs rivaling obstructive CAD. There are 2-3 million US women with CMD, and 100,000 new~     cases projected annually placing CMD prevalence, morbidity and costs higher than all female~     reproductive cancers combined.~      Among women with ischemia, preserved ejection fraction and no obstructive CAD, it has been~     observed that there are relatively more new onset heart failure (HF) hospitalizations than~     nonfatal myocardial infarction (MI). It has been hypothesized that CMD contributes to left~     ventricular (LV) diastolic dysfunction and subsequent heart failure with preserved ejection~     fraction (HFpEF). Preliminary data further suggests that left ventricular diastolic~     dysfunction is linked to CMD via a mechanism of augmentation and/or perpetuation by~     cardiomyocyte fat accumulation. HFpEF is prevalent in women and older men, but poorly~     understood. Mechanistic understanding is critical to HFpEF intervention and guideline~     development.~      The study hypotheses are as follows:~        1. Risk factor conditions (hypertension, dyslipidemia, dysglycemia, loss of estrogen)~          promote an inflammatory and pro-oxidative state making the microvasculature vulnerable;~        2. Vulnerable coronary microvasculature becomes dysregulated (sympathetic nervous system~          activation, endothelial dysfunction, changes in vascular smooth muscle activation,~          spasm) causing repeated episodes of transient ischemia;~        3. Repeated ischemia-reperfusion episodes facilitate preconditioning with preservation of~          cardiomyocyte contractile and microvascular function against ischemic injury;~        4. Ischemia-reperfusion and preconditioning lead to cardiomyocyte fat accumulation and~          relaxation impairment resulting in diastolic dysfunction and heart failure with~          preserved ejection fraction (HFpEF).~   "
75247|NCT02582008|"~     This pilot randomized clinical trial studies how well bupropion hydrochloride works compared~     with patient's choice for quitting smoking in patients with squamous cell head and neck~     cancer undergoing radiation therapy with or without chemotherapy. Bupropion hydrochloride may~     help patients quit smoking by enhancing central nervous system neurotransmitters~     noradrenergic and dopaminergic release. It is not yet known whether bupropion hydrochloride~     is more effective than patient's choice in helping quit smoking in patients with squamous~     cell head and neck cancer undergoing radiation therapy with or without chemotherapy.~   "
75248|NCT02581995|"~     To evaluate the change in quality of life (NEI VFQ 25) in subjects with DME during the first~     year of treatment with aflibercept according to the EU Label.~   "
75249|NCT02581982|"~     This phase II trial studies how well paclitaxel and pembrolizumab works in treating patients~     with urothelial cancer that has not responded to previous treatment and has spread to other~     places in the body. Drugs used in chemotherapy, such as paclitaxel, work in different ways to~     stop the growth of tumor cells, either by killing the cells, by stopping them from dividing,~     or by stopping them from spreading. Monoclonal antibodies, such as pembrolizumab, may~     interfere with the ability of tumor cells to grow and spread. Giving paclitaxel together with~     pembrolizumab may be an effective treatment for urothelial cancer.~   "
75250|NCT02581969|"~     Following the performance of the POTTER observational study, whose primary objective was to~     collect data on the benefits of secondary prophylaxis versus on demand treatment in terms of~     prevention of bleeding episodes, the present study aims to extend the observation time up to~     10 years, of the same population involved in the previous study.~      The present study has been designed to allow a focus on long term disease-related damage at~     joint level in subjects with severe haemophilia A, as well as on the pharmacoeconomics impact~     of the two different treatment regimens.~   "
75279|NCT02581592|"~     This multiple-center, nonrandomized, open label, parallel group, single dose study will be~     conducted in male and female subjects with normal hepatic function or moderate (Child-Pugh~     Class B) hepatic impairment to evaluate the effect of hepatic impairment on the~     pharmacokinetics (PK) of TD-4208.~   "
75251|NCT02581956|"~     Breast cancer is the leading cancer in women worldwide. The incidence of breast cancer is~     increasing probably due to the prolonged life expectancy and a variety of environmental~     factors. Fortunately, breast cancer outcome and survival are improving due to early detection~     and new treatment modalities. After making first strides against breast cancer, i.e.~     undergoing ablation surgery, most breast cancer survivors still have to go through a series~     of chemotherapy, which could prolong their survival but almost inevitably downgrade their~     quality of life due to grueling side effects, such as lack of energy and vulnerability to~     infection. Numerous medical interventions have been tried by healthcare providers to~     alleviate these side effects, but some of them are expensive and therefore become another~     burden for the cancer-afflicted patients. Previous studies have already indicated that~     exercise generated long-term benefits to breast cancer survivors, including improved physical~     functions, elevated maximal oxygen intake, decreases in lethargic symptom, increase in both~     immune function and quality of life. Among a variety of exercises, walking is the least~     costly, easy-to-follow type. Through a simple, predesigned walking regimen, the investigators~     expected that the breast cancer patients undergoing chemotherapy could cost-effectively reap~     some benefit either physically or psychologically.~      Cluster of differentiation 3 (CD3+), presenting at all stages of T-cell development, is a~     useful maker to identify T-cells. (Cluster of differentiation 4)CD4+ T cells, also known as T~     helper cells, play an assistant role in the immunologic process, such as maturation of B~     cells, activations of macrophages or cytotoxic T cells. Cluster of differentiation 8 (CD8+) T~     cells, known as cytotoxic T cells, responsible for destroying virus-infected cells and tumor~     cells. Generally, the counts of CD3+ T cells, CD4+ T cells and CD8+ T cells could be a~     reflection of immune system health. Short-Form 36(SF-36), a patient-reported survey, is a~     widely adopted tool to evaluate patient's individual health status. By means of serial blood~     sample collections and the delivery of SF-36 survey, this study aimed to objectively and~     quantitatively evaluate the effects of aerobic walking on the breast cancer patients~     undergoing chemotherapy.~   "
75252|NCT02581943|"~     This randomized pilot phase II trial studies the effect of pembrolizumab with or without~     carboplatin and paclitaxel on immune response in patients with non-small cell lung cancer~     that has come back or stage IIIB-IV. Monoclonal antibodies, such as pembrolizumab, may~     interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy,~     such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Giving pembrolizumab together with carboplatin and paclitaxel may improve immune~     responses in patients with non-small cell lung cancer.~   "
75253|NCT02581930|"~     This phase II trial studies how well ibrutinib works in treating patients with stage IV~     melanoma of the skin that has not responded to previous treatment. Ibrutinib may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
75254|NCT02581917|"~     This research trial studies metabolic changes in blood samples from patients with acute~     myeloid leukemia. Studying samples of blood from patients with acute myeloid leukemia in the~     laboratory may help doctors learn more about cancer and the development of drug resistance.~   "
75255|NCT02581904|"~     The purpose of this study is to determine if the application of a negative pressure dressing~     intraoperatively (Prevena; KCI, Inc) to vascular groin incisions decreases the wound~     complication rate in high risk patients.~   "
75256|NCT02581891|"~     This study aims to evaluate the optimal use, efficacy, and safety of a Treat-and-Extend~     regimen with aflibercept in subjects with nAMD.~   "
75257|NCT02581878|"~     To establish a recommended dose of BAY1862864 Injection and to investigate how the study drug~     acts in the body, on the cancer cells and how safe it is in patients with advanced~     non-Hodgkin's lymphoma (NHL)~   "
75258|NCT02581865|"~     Phase 2, double-blind, placebo-controlled study to assess the safety and efficacy of~     NBI-98854 administered once daily (qd) for a total of 8 weeks of treatment. This study will~     enroll approximately 90 male and female subjects clinically diagnosed with Tourette Syndrome.~   "
75259|NCT02581852|"~     This study compares workability in subjects with seropositive rheumatoid arthritis (RA) in~     the working age with high and low disease activity. Further interest is to clarify the~     influence of frailty, functional ability and muscle strength on workability and to determine~     the effect of disease activity on selected physiological needs (sleep quality, sexual~     functioning). Methods include a physical examination, questionnaires and physical tests.~   "
75260|NCT02581839|"~     Subjects are asked to take part in a clinical research study that tests Eribulin, a new drug.~     Eribulin is an investigational (experimental) anti-cancer agent that has not been approved by~     the Food and Drug Administration (FDA) for use in patients with brain metastases. Eribulin is~     FDA approved for use in patients with metastatic breast cancer but the effect it may or may~     not have on brain metastases has not been studied.~   "
75261|NCT02581826|"~     The objectives of the present study aims to evaluate the safety and efficacy of Silodosin in~     a population of patients wih Premature Ejaculation (PE). Coupled with efficient diagnosis, it~     is hoped that the newer agent will improve the quality of life for patients who suffer from~     Premature Ejaculation (PE).~   "
75262|NCT02581813|"~     The purpose of this study is to examine whether increased dairy intake, at the level~     recommended by Canada's Food Guide, combined with healthy eating and exercise, will improve~     body composition and bone turnover over 12 weeks in overweight and obese girls.~   "
75263|NCT02581800|"~     Background: Premature infants and their patents are discharged earlier from hospital and sent~     home in early in-homecare programs. Research regarding the use of health IT is needed to say,~     whether the use of videoconference and Smartphone application is a viable option to address~     the parents need for support in relations to early discharge.~      Aim: Test and explore early in-homecare (PreHomeCare) with videoconference and mobile~     application versus hospital consultations.~      Method: Main study; a randomized controlled intervention study with the hypothesis; parent of~     premature infants who have access to electronic knowledge and participatory guidance 24-7:~     increases proportion of exclusive breastfeeding, Improves parent/infant interaction, enhances~     confidence and increases knowledge.~      Sub study 1; a field study. Sub study 2; an interview study. Perspectives: It is expected~     that this project will be an argument in development of care for premature infants and~     telemedicine use in the future~   "
75264|NCT02581787|"~     The SABR-ATAC trial (Stereotactic Ablative Radiotherapy and anti-TGFB Antibody Combination)~     is a phase I/II trial that studies the side effects and efficacy of fresolimumab, an~     anti-transforming growth factor beta (TGFB) antibody, when given with stereotactic ablative~     radiotherapy in patients with stage IA-IB non-small cell lung cancer. Fresolimumab may~     inhibit radiation side effects and block tumor growth through multiple mechanisms.~     Stereotactic ablative radiotherapy (SABR), also known as stereotactic body radiotherapy~     (SBRT), is a specialized form of radiation therapy that precisely delivers high dose~     radiation directly to tumors, thus killing tumor cells and minimizing damage to normal~     tissue. Giving fresolimumab with SABR may work better in treating patients with early stage~     non-small cell lung cancer than treating with SABR alone.~   "
75265|NCT02581774|"~     The purpose of this study is to evaluate the risk of cesarean delivery in pregnancies~     complicated with isolated oligohydramnios managed by induction of labor. This prospective~     case-control study was conducted in Hamıdıye Sisli Etfal Teaching and Research Hospital~     between January 2013 and June 2014. 159 women with isolated oligohydramnios and 165 women~     with postdate pregnancies who met the inclusion criteria underwent induction of labor with~     dinoprostone or oxytocin. The rate and the indications of C/S deliveries were compared~     between two groups.~   "
75266|NCT02581761|"~     A randomized prospective double blind study of misoprostol administration in asymptomatic~     patients with pregnancies of unknown location.~   "
75267|NCT02581748|"~     Assessment of safety of HLX02 at different doses. Randomised, double-blind, parallel group~     Phase I study to compare PK profiles and to assess the safety and immunogenicity between~     HLX02 and Herceptin® (U.S. and German).~   "
75268|NCT02581735|"~     Research project whose main objective is to evaluate the use of a technology platform~     (uPatient) to register the prophylactic treatment of patients with hemophilia treated in~     different Hematology and Hemotherapy services of several hospitals in Spain.~   "
75269|NCT02581722|"~     A new Male Circumcision (MC) device, PrePex, has shown great promise as a way to radically~     shift the MC landscape. PrePex is an innovative circumcision device requiring no injected~     anesthesia, sutures, or sterile settings. Moreover, it is designed for use by minimally~     skilled healthcare professionals rather than surgeons. Two initial studies conducted in~     Rwanda in 2010 and 2011 demonstrated an excellent safety profile when the procedure was~     performed by skilled physicians~   "
75270|NCT02581709|"~     The goal of this research study is to test the feasibility of an intervention programme to~     reduce cognitive impairment due to cancer treatment. The investigators want to find out how~     acceptable the intervention and procedures are for cancer patients.~   "
75271|NCT02581696|"~     An open-label, multiple-dose, single-arm, phase 1 study to evaluate the drug-drug interaction~     and safety of Lafutidine and Irsogladine maleate in healthy adult volunteers~   "
75272|NCT02581683|"~     Proper analgesia after total knee arthroplasty (TKA) is important for encouraging early~     ambulation, which can facilitate improved patient outcomes and early hospital discharge. For~     pain control after TKA, adductor canal blocks (ACBs) improve upon the gold standard femoral~     nerve blocks (FNBs) since they do not cause as much quadriceps muscle weakening, while~     providing equivalent analgesia. Multimodal analgesia has become commonplace as a method of~     superior pain control with fewer side effects. Magnesium sulfate as an adjuvant to FNB local~     anesthetics can improve pain control after surgery; however, it also prolongs time to~     ambulation. There are no reports on the effect of magnesium sulfate in ACBs on analgesia~     after TKA. Thus the purpose of this randomized, double-blind, controlled trial is to~     determine whether magnesium sulfate given with local anesthetics via ACB can prolong~     analgesia, reduce pain scores and opioid consumption, and increase mobilization in TKA~     patients.~   "
75273|NCT02581670|"~     Investigators designed a phase II study to evaluate safety and efficacy of lung and liver~     stereotactic radiation therapy (SRT) in oligometastatic breast cancer patients unsuitable for~     surgery, using VMAT RapidArc approach.~   "
75274|NCT02581657|"~     This study is a randomized, double-blind (Investigator and study subject), placebo controlled~     multiple dose sequential ascending dose study that will enroll up to 47 male and female~     subjects with type 2 diabetes mellitus (T2DM) in up to four cohorts.~   "
75275|NCT02581644|"~     The purpose of the study is to determine a) if the implementation of belatacept patient alert~     card (PAC) resulted in effective understanding of key safety messages and b) if the degree of~     understanding of key safety messages is associated with improved clinical and safety~     outcomes.~   "
75276|NCT02581631|"~     The purpose of this study is to determine whether Nivolumab, in combination with brentuximab~     vedotin, is safe and effective in patients with certain subtypes of non-Hodgkin's lymphomas~     with CD30 expression that have not responded to treatment or have come back. The subtypes we~     are studying are Diffuse Large B-Cell Lymphoma (DLBCL), Peripheral T-Cell Lymphoma (PTCL),~     Cutaneous T-Cell Lymphoma (CTCL), Primary Mediastinal Large B-Cell Lymphoma (PMBL) and~     Mediastinal Gray Zone Lymphoma (MGZL).~   "
75277|NCT02581618|"~     Myocardial injury occurs after percutaneous coronary intervention due to micro emboli,~     ischemia-reperfusion injury or side branch occlusion. 3 cycles of ischemic preconditioning~     has been shown to be useful in preventing myocardial injury but it is not suitable to perform~     it especially in ad hoc interventions. In this study the investigators aim is to show whether~     one cycle remote ischemic preconditioning will be enough to prevent myocardial injury during~     percutaneous coronary intervention.~   "
75278|NCT02581605|"~     For participants whose leg bones don't line up properly, extra stress is placed on either the~     inner or outer side of the knee joint due to uneven transfer of body-weight. Gradually, this~     extra pressure wears away the smooth cartilage, resulting in osteoarthritis on that side of~     the knee joint. This problem is particularly common in young athletes and places them at risk~     of early osteoarthritis.~      An operation exists whereby one of the bones either side of the knee is cut ( an osteotomy)~     and hinged open to straighten the leg. This alteration redistributes body-weight more equally~     across the knee joint and is known to be effective in delaying and possibly preventing, the~     progression of knee osteoarthritis- especially in younger and physically more active patients~     in whom a knee replacement is undesirable.~      Currently it is possible to ( accurately) calculate the precise position of the bone cut and~     number of degrees correction required to straighten a leg using digital x-rays and~     three-dimensional CT scans. However there is no method of implementing this pre-operative~     plan during surgery so that the majority of surgeons rely on relatively crude and ipso facto~     unreliable intra-operative measurements as a guide.~      To improve the accuracy of this operation, the investigator propose the use of a custom-made~     'cutting block', tailored for each individual patient and its shape will match the contour of~     the patient's bone to ensure it can only be placed in one position. Pre-cut slots and holes~     will then guide the saw cut and the number of degrees the bone in hinged open, as per the~     pre-operative plan; it functions as an intra-operative template for the surgeon.~      This study will primarily examine whether there is a close match between the planned and~     actual correction of leg deformities when using a patient-matched cutting-block.~   "
75280|NCT02581579|"~     This is a doble-blind, masked, compared with placebo clinical trial in pediatric population~     in contact with tuberculosis with or without tuberculosis infection. This trial aims to study~     the effect of the probiotic Nyaditum resae® at the level of specific Treg memory cells eight~     weeks after the first administration, and the global tolerability of the treatment.~      Nyaditum resae® is a preparation in the form of capsules containing heat-killed environmental~     mycobacteria Mycobacterium manresensis. The overall objective of the study is the effect of~     Nyaditum resae® on immunity, which could reduce the risk of developing active tuberculosis.~   "
75281|NCT02581566|"~     Comparison between intrathecal Dexmedetomidine versus Intraarticular Dexmedetomidine on~     postoperative pain after knee arthroscopy.~   "
75282|NCT02581553|"~     This study will assess relative bioavailability of lesinurad/allopurinol fixed dose~     combination (FDC), its individual components and the effect of food.~   "
75283|NCT02581540|"~     The aim of this observational study is twofold. The primary hypothesis being tested is that~     initial(first) high sensitivity Tn <5ng/l (limit of detection) combined with an ECG with no~     ischaemic changes is superior as an accelerated diagnostic tool/strategy compared to TIMI~     score (<2), GRACE <75 and HEART score ≤ 3. (Hs tn T- Roche elecsys HS tn T) and also against~     HS troponin at the 99th percentile (<15ng/l with nonischaemic changes)- again all scored with~     initial (first tn ) only.~      The second aim is to directly compare the three established methods of risk stratifying~     patients (predicting risk in suspected heart attacks) namely, the Global Registry of Acute~     Coronary Events (GRACE), Thrombolysis in Myocardial Infarction (TIMI) and HEART score in the~     era of high sensitivity troponins performs best.~   "
75284|NCT02581527|"~     In this trial, the investigators are assessing whether giving an increased dose of rifampicin~     to patients receiving the standard treatment for tuberculosis is safe and, when given for 4~     months only, will also result in greater and faster killing of the tubercle bacillus in the~     lungs and result in relapse rates similar to those found in the World Health Organisation~     (WHO) recommended standard 6 month regimen.~   "
75285|NCT02581514|"~     Eosinophilia, defined by a blood eosinophil granulocytes rate greater than 500 / mm3, is~     frequently encountered in internal medicine.~      Its causes are varied: atopy, drug allergies, parasitic infections, autoimmune diseases and~     solid neoplasias. Over 200 etiologies have been reported, some difficult to diagnose and can~     be life-threatening Eosinophilia can be a diagnostic dilemma, as the etiologies are extensive~     and varied.~      The aim of this study is to assess the feasibility of a diagnostic approach based on a~     decision algorithm in a group of patients with eosinophilia.~      We assume that a procedure with a hierarchy of additional tests would increase the frequency~     of diagnosed cases while decreasing the time to diagnosis.~      This procedure defined by an algorithm would even reduce the number of tests necessary to~     reach a diagnosis.~   "
75286|NCT02581501|"~     GAX represents a novel approach to the development of cancer chemotherapy agents in~     pancreatic cancer and is based upon extensive laboratory investigations for the induction of~     apoptosis in pancreatic carcinoma cells.~   "
75287|NCT02581488|"~     This study is designed to test the hypothesis that daily treatment of diabetic foot ulcers~     with an enzymatic debriding agent, SANTYL, for up to 6 weeks will result in more rapid~     decrease in ulcer area than diabetic foot ulcers treated with a topical treatment containing~     silver. After meeting study criteria, participants will be randomly assigned to apply Santyl~     or a topical treatment containing silver to their to foot ulcer for up to 6 weeks. At the end~     of 6 weeks, participants will be followed for an additional 4 weeks to examine the outcome of~     the study treatment.~   "
75288|NCT02581475|"~     Segmental examination twice of the proximal colon might be helpful to increase adenoma~     detection rate (ADR).~   "
75289|NCT02581462|"~     Previous studies provide a strong theoretical rationale for the conduct of a randomized study~     evaluating the efficacy and safety of Herceptin and pertuzumab in combination with FLOT in~     the perioperative treatment of resectable HER-2 positive adenocarcinoma of the stomach or~     GEJ.~   "
75290|NCT02581449|"~     The purpose of the study is to evaluate the effect of omega-3 fatty acids supplementation on~     pediatric patients undergoing hemodialysis via the measurement of the following before and~     after omega-3 administration:oxidative stress markers, inflammatory markers and serum lipids.~   "
75291|NCT02581436|"~     This study evaluates the addition of Kidney Solid Organ Rejection Test (kSORT), in the~     clinical follow-up of renal transplant recipients, compared to clinical standard surveillance~     in the first two years after kidney transplantation. The design of the study is a partially~     blinded, randomized control trial of patients with living and deceased donor. The recruitment~     will be in a third level attention hospital in Mexico city (Instituto Nacional de Ciencias~     Médicas y Nutrición Salvador Zubirán). The main outcomes are the rate and grade of acute~     rejection, histologic chronic index of the one year protocol biopsy and glomerular filtration~     rate.~   "
75292|NCT02581423|"~     This study will evaluate the safety and tolerability of capecitabine (Xeloda) in participants~     who have undergone surgery for colon cancer. Oral Xeloda will be administered twice daily in~     3-week cycles for a total of up to 8 cycles. The anticipated time on study treatment is 24~     weeks, and the target sample size is 70 individuals.~   "
75293|NCT02581410|"~     The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals'~     HZ/su vaccine in adults ≥ 65 years of age with and without Zostavax® vaccination at least 5~     years earlier.~   "
75294|NCT02581397|"~     This study evaluates the non-inferiority of Suppository Transpulmin and Suppository Guaiacol~     compared to Transpulmin Syrup in the treatment of cough with secretion of infectious origin~     in children between two and six years old. One third of participants will receive Suppository~     Transpulmin, the other one third will receive Suppository Guaiacol and the last one third~     will receive Transpulmin Syrup.~   "
75295|NCT02581384|"~     This research study is studying stereotactic body radiotherapy (SBRT) as a possible treatment~     for lung relapse of Ewing sarcoma, rhabdomyosarcoma, osteosarcoma, non-rhabdomyosarcoma soft~     tissue sarcoma, Wilms tumor or other primary renal tumor (including clear cell and rhabdoid).~     SBRT is a form of targeted radiotherapy that can treat very small tumors using a few large~     doses.~   "
76062|NCT02571374|"~     This is a double blind randomized trial in which patients with colorectal cancer undergoing~     surgery will be selected to receive either a symbiotic formulation or placebo. The~     researchers will compare incidence of surgical site infection between the study groups.~   "
75296|NCT02581371|"~     The aim of the present clinical phase IV study is to estimate the influence of Cerebrolysin~     in combination with standard therapy on the dynamics of recovery of the paretic upper limb in~     patients with acute ischemic stroke.~      Each patient participates in the study for 176-190 days (approximately 6 months). The~     estimated duration of the study is 2 years.~   "
75297|NCT02581358|"~     The purpose of the study is to investigate the validity of Scolioscan for quantitative~     assessment of curve severity in scoliosis using x-ray radiographs as the gold standard.~   "
75298|NCT02581345|"~     The purpose of the study is to evaluate efficacy, safety, and immunogenicity of a proposed~     adalimumab biosimilar (M923) and Humira in participants with moderate to severe chronic~     plaque-type psoriasis.~   "
75299|NCT02581332|"~     The purpose of this study is to examine the effects of a brief mindfulness meditation~     intervention on clinical and experimental pain in fibromyalgia (FM) patients as compared to a~     wait-list control condition. Based on prior research, investigators' working hypothesis is~     that this intervention will decrease the severity of FM-associated clinical pain and~     experimentally induced pain in comparison to pre-intervention scores and a wait-list control~     group. Additionally, based on prior work, investigators postulate that mindfulness meditation~     training will decrease a) depression, b) state anxiety, c) overall disease severity, and d)~     perceived stress, while increasing e) quality of sleep, and f) mindfulness skills in~     comparison to pre-intervention scores and the wait-list control group.~      Investigators will also be testing if decreases in pain ratings during meditation correspond~     to increases in parasympathetic activity. The relative systemic contributions of the~     parasympathetic and sympathetic branches of the Autonomic Nervous System (ANS) can be~     examined by measuring heart rate variability (HRV), or the variability in the beat-to-beat~     interval. Fast acting, parasympathetically-mediated high frequency (HF) changes in heart rate~     variability (HF HRV; 0.15-0.40 Hz) provide a reliable indicator of parasympathetic activity.~     Importantly, decreased HF HRV correlates with increased pain. Investigators therefore will~     employ psychophysical and physiological methodologies to test the hypothesis that the~     analgesic effects of mindfulness meditation in FM patients are associated with increases in~     HF HRV.~   "
75300|NCT02581319|"~     Smoking has been considered the most important risk factor for periodontitis among all~     lifestyle factors. Fewer studies evaluated longitudinal clinical and microbiological status~     of smokers undergoing periodontal maintenance therapy and controversial results were found.~     This study will evaluate clinical conditions and prevalence of putative periodontopathogens~     and Candida spp. in smokers and non-smokers at baseline and after 3 and 6 months of~     nonsurgical periodontal therapy. Clinical parameters, including oral status assessed using~     Plaque Index (PI), Bleeding On Probe (BOP), Pocket Probing Depth (PPD), Gingival Recession~     (GR), Clinical Attachment Level (CAL) will be measured in smokers and non-smokers patients~     with chronic periodontitis. Samples of subgingival biofilm will be obtained from the~     periodontal pockets and furcation sites and submitted to phenol-chloroform DNA extraction and~     Polymerase Chain Reaction (PCR) analysis using specific primers for Aggregatibacter~     actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Prevotella intermedia,~     Campylobacter rectus, Candida albicans, Candida glabrata, Candida tropicalis and Candida~     dublinienses.~   "
75301|NCT02581306|"~     If eligible to participate in the research study after completing the physical screening~     procedures, participants will be asked to return to the Substrate Metabolism Laboratory on~     another occasion after a short fast (no food or beverages - besides water) for at least 6~     hours. After participants arrive, participants will rest quietly for approximately 30 min.~     The investigators will then collect a blood sample from a vein in participants hand, or~     forearm. After obtaining a baseline blood sample, participants will exercise at a moderate~     intensity (on a treadmill or a stationary bike) for one hour. This one hour moderate exercise~     session will feel like a slow jog during which participants would be able to carry a~     conversation. In order for the investigators to measure energy expended and the amount of fat~     participants are burning during exercise, the investigators will periodically ask~     participants to breathe through a mouthpiece so the investigators can collect participants~     expired breath. After the exercise session the investigators will collect another blood~     sample from a vein in participants hand, or forearm.~   "
75302|NCT02581293|"~     In this study the investigators want to asses the effect of peritonisation at c-section on~     postoperative vital signs which was thought to be an indirect finding secondary to increased~     sympathetic activity originated from pain caused by stretched peritoneum.~   "
75303|NCT02581280|"~     Extracorporeal membrane oxygenation (ECMO) is the device which increases the supply of oxygen~     to the body tissues in vitro and to assist in heart and lung function. Venoarterial (VA) ECMO~     is used in patients with cardiogenic shock, cardiac arrest, ventricular arrhythmia and is~     able to secure a time to self-recovery by reducing the excessive stimulation applied to the~     heart. However, in ECMO patients, pharmacokinetics of drugs are changing such as increased~     volume of distribution (Vd) or decreased clearance (CL). For this reason, it is hard to~     provide the best treatment in ECMO patients. The study is to evaluate whether the PK of drugs~     is influenced by VA ECMO and to recommend the optimal dosing strategies for proposed drugs in~     adult patients receiving VA ECMO.~   "
75304|NCT02581267|"~     Psychiatric presentations are common in the emergency department (ED), and determining~     whether or not a psychiatric presentation is due to medical illness can be a difficult task~     for the emergency physician. The investigators define serious medical illness (SMI) as a~     pathological condition that would necessitate inpatient treatment on a medical or surgical~     ward. It is important for patient safety that SMI be triaged by the emergency physician to~     the appropriate inpatient service. The rate of missed SMI in patients with psychiatric~     presentations to the ED is unknown. The investigators will research missed SMI in patients~     referred to adult psychiatry from the ED, with the intent to improve patient safety.~   "
75305|NCT02581254|"~     Cold snare polypectomy (CSP) is now common practice and has proven to be a safe and effective~     technique for removal of diminutive polyps. Both thick and thin wire snares are now commonly~     used for CSP. However, because of their physical characteristics, thick wire snares might~     leave a higher percentage of residual adenoma at the resection site. Since this may result in~     a higher risk of recurrence, the technique needs to be optimized. Experts have suggested that~     a thin wire snare might be more efficient, with a lower risk of residual adenoma at the~     resection site and consequently a lower risk of recurrence and interval cancer.~   "
75306|NCT02581241|"~     The drug-induced long QT syndrome (diLQTS) describes a clinical entity in which~     administration of a drug produces marked prolongation of the QT interval of the~     electrocardiogram, associated with the development of a polymorphic ventricular tachycardia,~     termed torsades de pointes (TdP). The heart rate is an important variable affecting the QT~     interval. The QT interval normally shortens as the heart rate accelerates; however, the~     adaptation of the QT interval to sudden heart rate acceleration is not instantaneous.~     Interestingly, Holter studies show that the speed of response of the QT interval to sudden~     changes in heart rate (that is, the time it takes the QT interval of a given person to reach~     a new steady-state QT/RR relation) in healthy persons is highly individual and independent of~     the basic QTc. The investigators and others recently proposed the quick standing test as a~     simple bedside test that facilitates the diagnosis of congenital LQTS. The test takes~     advantage of the fact that as one stands up, the heart rate acceleration is abrupt while the~     associated QT-interval shortening is gradual. As the R-R interval shortens faster than the QT~     interval, the QT appears to stretch toward the next P wave and the corrected QT interval~     (QTc) for heart rate actually increases momentarily. The phenomenon of QT stretching is~     universal but is exaggerated in patients with LQTS, allowing for a simple but accurate~     diagnostic test. There is no data on the effects of quick standing on drug-associated form of~     the long QT syndrome. The investigators therefore propose the present study to better~     understand who these patients with drug-associated form of the long QT syndrome are and what~     the significance of their abnormal QT-response is.~   "
75307|NCT02581228|"~     This is a retrospective, open label study to establish and validate a prediction technology~     for advanced melanoma patients under the 1st, 2nd and later treatment lines, with the~     immunotherapeutic drugs Ipilimumab, Pembrolizumab & Nivolumab, in order to predict response~     rate and disease progression~   "
75308|NCT02581215|"~     This is a phase II, multicenter, double-blinded, randomized, 2-arm trial evaluating the~     efficacy and safety of mFOLFIRINOX plus ramucirumab (Arm A) vs. mFOLFIRINOX plus placebo (Arm~     B) in 94 subjects with advanced pancreatic cancer, not amenable to curative treatment. Both~     arms will continue treatment until disease progression or unacceptable toxicity.~   "
75309|NCT02581202|"~     This study seeks to assess the virologic effectiveness of dual therapy (lopinavir/ ritonavir~     (LPV/r) + lamivudine (3TC)) in treatment-experienced human immunodeficiency virus 1 (HIV-1)~     infected participants with an undetectable plasma HIV-1 (ribonucleic acid) RNA level (for at~     least 6 months) at the 48 week time point of treatment in the routine clinical settings of~     the Russian Federation.~   "
75310|NCT02581189|"~     This study seeks to provide evidence of the effectiveness and obtain patient reported outcome~     (PRO) data for the interferon-free ABBVIE REGIMEN ± RBV in participants with chronic~     hepatitis C (CHC) in a real life setting across clinical practice patient populations in~     Canada.~   "
75311|NCT02581176|"~     This study is a single-arm, phase IV trial, of apixaban as treatment of venous thrombosis in~     patients with cancer. The current standard treatment of venous thrombosis in cancer patients~     is subcutaneous injections with low molecular weight heparin. During the last 5 years several~     new direct acting oral anticoagulants have been tested out as treatment of venous thrombosis.~     But very few cancer patients were included in the phase III clinical trials of the direct~     acting oral anticoagulants. Thus, there is a lack of information on how cancer patients with~     venous thrombosis will respond to treatment with direct acting oral anticoagulants. The~     current study will investigate the direct acting oral anticoagulant apixaban in cancer~     patients with venous thrombosis.~   "
75312|NCT02581163|"~     This study is to provide evidence of the effectiveness as well as the influence of adherence~     on treatment outcome of Paritaprevir/ritonavir, Ombitasvir, +/- Dasabuvir, (the ABBVIE~     REGIMEN) ± Ribavirin (RBV) in a real world setting of hepatitis C virus infected clinical~     practice populations across Belgium. The study may also help identify predictive factors of~     response that are important in real world treatment settings. In addition, it will provide~     data on the impact of adherence on treatment outcomes in everyday settings, which may help~     treating physicians to improve the management of participants under their care.~   "
75313|NCT02581150|"~     The purpose of this study is to assess the efficiency of outpatient surgery compared to~     conventional hospitalization in endovascular treatment of occlusive arterial disease. A~     cost-utility analysis will be conducted from a societal perspective. Patients referred for~     peripheral arterial disease (PAD) will be randomized in two arms and a 3 months follow-up~     will be performed.~   "
75314|NCT02581137|"~     This phase IIa trial studies how well metformin hydrochloride works in preventing oral cancer~     in patients with an oral premalignant lesion (oral leukoplakia or erythroplakia). Oral~     premalignant lesions look like red or whitish plaques or lesions in the mouth that do not rub~     off and can be associated with a higher risk of cancer. Metformin hydrochloride may help~     prevent oral cancer from forming in patients with an oral premalignant lesion.~   "
75315|NCT02581124|"~     Study to evaluate the effect of lapatinib, a breast cancer resistance protein (BCRP)~     inhibitor, on the pharmacokinetics (PK) of JTZ-951 and to evaluate the safety and~     tolerability of JTZ-951 when administered alone and one hour after the administration of~     lapatinib.~   "
75316|NCT02581111|"~     Brain-dead patients who provide authorization for organ donation will be randomized to~     naloxone or placebo if baseline arterial blood gas (ABG, after initiation of OPO management)~     reveals hypoxemia (PF ratio < 300), unless they have already been ruled-out for lung~     recovery. Investigators aim to assess whether naloxone improves oxygenation prior to organ~     recovery more than placebo.~   "
75317|NCT02581098|"~     This study aims to determine if elevated wound-edge endothelial miR-200b is a barrier to~     wound healing in diabetic patients and also to determine if ex vivo supplementation of miR-21~     mimic and recombinant MFG-E8 resolve inflammation in wound macrophages isolated from NPWT~     sponges from diabetic wounds. This study will enroll 124 (60 in the miR-200b arm and 64 in~     the miR21 arm) Diabetic Wound patients who have wound tissue oxygenation adequate to support~     wound healing and will be in the study for 14 weeks that includes 4 study visits.~   "
75602|NCT02577367|"~     The study aims to describe the changes in Levothyroxine dosage requirements in patients with~     hypothyroidism started on enteral feeding, and assess whether giving levothyroxine on empty~     stomach affects the mean percentage increase expected in Levothyroxine dosage in these~     patients.~   "
75318|NCT02581085|"~     The purpose of this Phase IIA trial is to validate the outcome observed in the Phase I trial~     that oral TCT attenuates the rise in MELD over time in patients diagnosed with NAFLD, NASH or~     chronically infected hepatitis C. Subjects will participate for 3 years. They will be asked~     to come to 8 total study visits and will receive 6 follow-up phone calls within the 3 years~     of participation. Subjects will be asked to take 2 study capsules of vitamin E Tocotrienol~     (200mg) twice a day or 2 placebo capsules twice a day. The study is randomized and study~     staff will be blinded to randomization.~   "
75319|NCT02581072|"~     The study is a 4 way cross-over study in subjects with moderate to severe acne vulgaris who~     will each receive SB204 4%, a supratherapeutic dose of SB204 (either 8 or 12%),~     moxifloxacillin (positive control) and appropriate placebo to match. SB204 will be applied~     topically to the upper back, upper chest, upper shoulders, and face.~   "
75320|NCT02581059|"~     This is a randomized, multi-center phase II study of ginseng in colorectal cancer patients~     treated with regorafenib to determine if ginseng will reduce fatigue in this patient~     population and improve adherence to regorafenib. Ninety (90) subjects will be enrolled and~     randomized using a 2:1 allocation, with 60 subjects enrolled in the regorafenib + ginseng~     group and 30 enrolled in the regorafenib + no ginseng group.~   "
75321|NCT02581046|"~     Congenital cataract is an important treatable cause of visual handicap in childhood~     throughout the world. Successful management of childhood cataract is dependent on~     individualized treatment strategies and rigorous postoperative supervision for adverse~     complication. In this trial, we aimed to compare the difference of postoperative outcome~     between surgical timing at age of 3 month and 6 month. Patients enrolled into the study will~     be followed for two year and will have study visits at 1 day, 1 week, 1 month, 3 month, 6~     month, 9 month, 12 month, 18month and 24month postoperatively.~   "
75322|NCT02581033|"~     Evaluation of the rate of sustained virological response among HBeAg-negativechronic~     hepatitis B patients who discontinue long-term NA therapy.~      During this study participants will cease their prescribed medications, this will occur with~     immediate effect once enrolled into the study. The duration of cessation will be indefinite,~     unless clinically indicated for NA therapy re-start. Participants will be monitored as per~     protocol following cessation, monitoring will be by clinic visit and through blood test to~     monitor virological response. Clinical visits will be at the intervals of week 2, week, 4,~     week 8, week 12, week 18, following this they will be every 3 months out to 2 years when the~     participant will have completed the trial. Once the participant has completed the trial they~     will not commence again, the aim is for an indefinite cessation of NA therapy.~   "
75323|NCT02581020|"~     This study seeks to assess the durability of response and persistence of resistance to~     ombitasvir/ paritaprevir/ritonavir in Japanese participants who enrolled in a Phase 2 or 3~     clinical study with these agents for the treatment of chronic hepatitis C.~   "
75324|NCT02581007|"~     This trial will evaluate the safety and efficacy of a reduced intensity allogeneic HSCT from~     partially HLA-mismatched first-degree relatives utilizing PBSC as the stem cell source. The~     primary objective of the study is to estimate the incidence of graft rejection and acute~     GVHD. A secondary objective will be to estimate the incidence of the relapse, NRM, OS,~     chronic GVHD and EFS.~   "
75325|NCT02580994|"~     This is a multicenter, open-label, two armed, controlled, and randomized phase II trial~     investigating the activity of pembrolizumab in combination with standard chemotherapy in~     Extensive Disease (ED)-SCLC.~   "
75326|NCT02580981|"~     Previous work performed by University of New Mexico Comprehensive Cancer Center (UNMCCC)~     investigators has revealed previously unknown genomic mutations in children, adolescents, and~     young adults with high-risk B and T cell precursor acute lymphoblastic leukemia (ALL). Using~     genomic and next generation DNA sequencing technologies, these investigators revealed that~     14% of children with high-risk ALL have Philadelphia chromosome-like (Ph-like) ALL.~     Patients with this form of ALL were found to have a significantly increased risk of treatment~     failure and death.~      Further work revealed that there are more than 40 distinct gene rearrangements and fusions~     that can result in Ph-like ALL. Cell lines and human leukemic cells expressing some of these~     different gene fusions were sensitive to currently available drugs. This suggests that~     Ph-like ALL patients with these specific distinct gene fusions should be targeted in future~     clinical trials to be treated with appropriate therapy. Further work is also needed to~     identify other potentially targetable genetic alterations in ALL patients.~      Therefore, the goal of this study is to perform genomic screening of all newly diagnosed ALL~     patients seen at UNM and to use this information to enroll patients onto available National~     Clinical Trial Network (NCTN) clinical trials. If an appropriate NCTN trial is not available,~     best clinical management will be pursued.~   "
75327|NCT02580968|"~     A random controlled trail to evaluate the efficacy of migraine standard electroacupuncture~     formula, and to analysis the regulation of the intensity-effects and to observe the~     peripheral NO, CGRP and NF-кB expression level of migraine patients after electroacupuncture~     treatment.~   "
75328|NCT02580955|"~     A physician initiated trial investigating the LEGFLOW Paclitaxel-Eluting Peripheral Balloon~     dilatation catheter for the treatment of femoropopliteal lesions longer than 15cm.~      Objective: to evaluate the short-term outcome of the treatment by means of the LEGFLOW~     Paclitaxel-Eluting Peripheral BAlloon Dilattaion for the treatment of long femoropopliteal~     lesions (TASC C&D).~   "
75329|NCT02580942|"~     The purpose of this study is to assess whether Acupoint Sticking in Treating Winter Diseases~     in Summer is effective in the treatment of chronic asthma.~   "
75330|NCT02580929|"~     This study aims to evaluate the effectiveness of radiotherapy before surgery in high-risk~     relapse hepatocellular cancer patients.~   "
75391|NCT02580136|"~     The purpose of this study is to collect and organize data into a repository to gather~     relevant information for future research from patients diagnosed with a rare malignant~     sinonasal cancer called esthesioneuroblastoma (ENB) and are scheduled to undergo endonasal~     skull base surgery. Data being collected includes surgical data, demographics, disease~     presentation, MRI, CT, PET imaging, and post-operative assessments including pathology tests.~     After surgery, the investigators will collect chemotherapy and radiation data. Participants~     will also complete quality of life questionnaires at their follow-up visits.~   "
76071|NCT02571257|"~     The purpose of this study is to evaluate the effect of gemcabene on LDL-C and other lipid~     parameters in hypercholesterolemic patients on a stable dose of a statin.~   "
75331|NCT02580916|"~     Background:~      Patient-reported outcome measures (PROMs) provide validated evidence of health and quality of~     life (QoL) from the patient perspective. Several national PROMs programmes have been~     implemented in the National Health Service - specifically for common elective procedures.~     Local implementation is varied across settings and populations. The incidence of non-melanoma~     skin cancer (NMSC) is rapidly increasing, posing considerable burden on UK healthcare~     resources, yet there is limited evidence of use of PROMs in NMSC and little information about~     patients' perceived health and QoL.~      Objectives:~      This study will explore feasibility of implementing a skin cancer-specific PROM - Skin Cancer~     Quality of Life Impact Tool (SCQOLIT) for NMSC.~      Methods:~      Three hundred patients with a pathological diagnosis of NMSC undergoing all treatment~     modalities will be recruited to complete SCQOLIT questionnaires at baseline, at 3, 6 and 9~     months. Participation and response rates, missing data and individual change scores will be~     analysed. Staff and patients will be interviewed to explore acceptability and feasibility of~     collecting PROMs data.~      Results:~      Interim results of the project to date will be presented. Feasibility will be assessed by~     evaluating number of eligible patients, number of consenting patients, reasons for not~     consenting and participant number. Individual longitudinal change in scores, response rates~     and psychometric properties of the SCQOLIT will be reported.~      Implications:~      Acceptability and feasibility of the SCQOLIT tool has never been rigorously assessed in~     Dermatology clinics. A validated NMSC-specific PROM would help standardize multi-centred~     trials, allow robust evaluation of quality of care and more appropriately direct healthcare~     resources to improve QoL in patients with NMSC.~   "
75332|NCT02580903|"~     This is an observational prospective study aiming to clarify the prevalence of pulmonary~     hypertension in patients with Myeloproliferative Neoplasms and their prognosis.~      All patients attending our department with the above mentioned neoplasms will be offered~     inclusion in this study. All will have an echo performed and patients identified as being at~     risk of pulmonary hypertension will be offered complete investigation as specified by the~     European Cardiology Association.~      All patients will be followed up for a total of five years to identify prognosis.~   "
75333|NCT02580890|"~     The purpose of this study is to determine whether transcranial direct current stimulation~     (tDCS) is effective in the treatment attention deficit hyperactivity disorder (ADHD).~      Randomized, double-blind Controlled Clinical Trial~      Subjects Adults (between 18 and 59 years of age) with ADHD who meet the inclusion criteria~     and who agree to participate in the study Will recruit from advertisements and clinical~     referrals to a PRODAH~      Active tDCS Anode - right DLPFC Cathode - left DLPFC Electric current is 2mA - Current is~     applied for 20 min~      Sham tDCS Same assembly is used Current is applied for 30 sec~      Both groups 5 stimulation sessions on consecutive days~      Following tools at Baseline, 1st week, 2 st week, 3st week and 4st week Adult ADHD~     Self-Report Scale (ASRS) SDS - Sheehan Disability Scale CGI - Clinical Global Impression~   "
75334|NCT02580877|"~     The study is a 2 arm, multi-center, randomized, open-labeled clinical trial designed to~     assess the effects of varying doses and schedules of oral insulin on immunological and~     metabolic markers in relatives at risk for type 1 diabetes (T1D).~   "
75335|NCT02580864|"~     Individuate possible predictive factors of anti-TNFalfa-induced deep remission in Crohn's~     disease.~   "
75336|NCT02580851|"~     Current guidelines for the diagnosis and management of patients with stable coronary artery~     disease (CAD) strongly support the performance of non-invasive imaging techniques for the~     detection of myocardial ischemia prior to revascularization procedures. This recommendation~     originates from the strong evidence base showing the lack of prognostic benefit from~     percutaneous coronary interventions (PCI) over optimal medical therapy in patients without~     verification of myocardial ischemia. On the other hand, it could be demonstrated that~     patients with functionally significant coronary artery stenoses do benefit from~     revascularization. Cardiac magnetic resonance imaging (CMR) has emerged to be a diagnostic~     modality of choice for the detection of myocardial ischemia with high sensitivity and~     specificity. The investigators therefore designed this prospective and randomized trial to~     compare a CMR-driven vs. angiography-driven management of patients with stable CAD concerning~     major cardiac endpoints, futile angiographies and quality of life.~   "
75337|NCT02580838|"~     The aim of this study is to determine whether early use of OnabotulinumtoxinA is more~     effective to improve functional outcomes of upper limb in patients with stroke.~   "
75338|NCT02580825|"~     The purpose of the study is to explore if self biofeedback program can reduce ground reaction~     force (GRF) from the lower extremity of the body and in the knee in particular and help obese~     children to avoid knee injuries.~   "
75339|NCT02580812|"~     The purpose of the study is to determine whether perinatal listeriosis is associated with~     long-term neurological consequences, and to evaluate the respective contribution of perinatal~     sepsis, of prematurity and of the known neurological tropism of the involved pathogen,~     Listeria monocytogenes.~   "
75340|NCT02580799|"~     A multi-center non-interventional, in-vitro trial for evaluation of concordance of the~     results for Human Epidermal Growth Factor Receptor 2 (HER2) expression by the~     Immunohistochemical (IHC) method in pathological samples collected from participants with~     breast cancer.~   "
75341|NCT02580786|"~     This study examines if the internet-based peer support has an effect on the breastfeeding~     attitude or the duration of breastfeeding in preterm infants and their mothers compared with~     mothers with routine care. The factors associated with the initiation of breastfeeding in the~     neonatal intensive care unit will be determined. In addition, the perceptions of the mothers~     of preterm infants about their needs and problems when breastfeeding their preterm infants~     are described.~   "
75439|NCT02579512|"~     The NIA algorithm is similar to the traditional 12-lead ECG equipment. By analyzing patient~     data, NIA algorithm provides more detailed results compared to traditional 12-lead ECG.~     Patients with suspected coronary artery disease are conventionally diagnosed and treated by~     cardiac catheterization. However, cardiac catheterization is invasive procedure. Unless~     clinical diagnosis is evident before cardiac catheterization, a treadmill exercise test, a~     nuclear medicine myocardial perfusion test, or a multi-direction coronary CT angiogram is~     usually performed to increase the accuracy of diagnosis. But these examinations are not~     accessible to all patients, and are time-consuming and costly.~   "
75342|NCT02580773|"~     Acute Chest Syndrome (ACS) is a pulmonary complication of sickle cell disease (SCD)~     representing the leading cause of death and the second cause of hospitalization among adult~     patients. Pulmonary vaso-occlusion is one of the main pathophysiologic hypotheses during ACS.~     Our hypothesis is that therapeutic anticoagulation may reduce the severity of ACS via the~     alleviation of pulmonary thrombosis. The main objective of this prospective, randomized,~     double-blind study is to test the efficacy and safety of a curative anticoagulation strategy~     during ACS. The main efficacy endpoint is time to ACS resolution. The main safety endpoint is~     number of major bleedings.~      A thoracic CT scan will be performed to check for pulmonary artery thrombosis. If the CT scan~     is positive (thrombosis within a large elastic artery), the patient will not be randomized~     and will be treated with a curative anticoagulation. If the CT scan is negative, the patient~     will be randomized to receive subcutaneous anticoagulation with low molecular weight heparin~     (tinzaparin) either at a curative dose (175 Unit International (UI)/kg/day for 7 days) or at~     a prophylactic dose (4500 UI/day).~   "
75343|NCT02580760|"~     This cross-sectional monocentric study will describe transgender men transitioning into women~     and who had cosmetic silicone injection.~      The principal objective is to estimate the prevalence of Transgender with circulating~     monocytes containing silicone vacuoles in blood smears among Male to Female Transgender~     population with a history of cosmetic silicon injections.~      The secondary objectives are to describe the transgender population, to describe the quantity~     of silicone in vacuoles of circulating monocytes, and the association between dermatological~     complications (inflammatory and not inflammatory) and several clinical and biological~     characteristics (HIV status, level of immunosuppression, inflammatory syndrome, quantity of~     silicone which was injected , silicone quantity in blood smears).~   "
75344|NCT02580747|"~     RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory~     into patient autologous or donor-derived T cells may make the body build immune response to~     kill cancer cells.~      PURPOSE: This clinical trial is studying genetically engineered lymphocyte therapy in~     treating patients with Relapsed and/or Chemotherapy Refractory Advanced Malignancies.~   "
75345|NCT02580734|"~     The purpose of this study is to determine whether melatonin is effective in the treatment of~     burning mouth syndrome (BMS).~   "
75346|NCT02580721|"~     Crestal bone and soft tissue stability around implants is an important issue in implant~     dentistry. Initial vertical mucosal tissue thickness was shown to be one of the factors~     having impact on bone stability. However, there is lack of data in the literature regarding~     the relationship between mucosal thickness and marginal bone loss around implants. Berglundh~     and Lindhe in an animal study reported that thin mucosal tissue causes significantly more~     crestal bone resorption around implants. In addition, clinical research regarding the effects~     of tissue thickness on bone and soft tissue stability around implants is lacking. The aim of~     this clinical study is to evaluate the influence of mucosal tissue thickness on soft and hard~     tissue changes around implants.~   "
75347|NCT02580708|"~     The purpose of this study is to evaluate the safety and anti-tumor effect of rociletinib when~     administered in combination with trametinib.~   "
75348|NCT02580695|"~     Knee-osteoarthritis (OA) is a common and disabling problem, that represents a global health~     issue since none of the current therapies are truly disease modifying. The use of mesenchymal~     stem cells (MSCs) in OA-preclinical models has been associated with a reduction in cartilage~     degradation, the attenuation of bone sclerosis and an effective anti-inflammatory response.~     Investigators have designed a randomized phase I/II placebo controlled trial of UC-MSCs in~     knee OA. Outcomes will be evaluated at 12 months, comparing monodosis versus double~     intra-articular injection, re-randomized at 6 months.~   "
75349|NCT02580682|"~     To observe the efficacy of Sanfu herbal patch and Sanfu moxibustion on persistent allergic~     rhinitis,and comparing the differences between the combination of these 2 methods with each~     method alone.~   "
75350|NCT02580669|"~     The goal of this study is to show pattern differences of vasoreactivity and connectivity~     between Progressive Multiple Sclerosis and Relapsing Remitting Multiple Sclerosis, by the use~     of methods of advanced brain MRIs and the Diffusion Tensor Imaging , and correlate these~     differences with Clinical disability and cognitive disorder results.~   "
75351|NCT02580656|"~     Survival rates in cancer continue to improve, with over 2 million adult cancer survivors in~     the United Kingdom, projected to increase to 4 million by 2030. Around 25% of these survivors~     require treatment for clinical levels of emotional distress. The investigators will conduct a~     phase I open trial to test the potential efficacy of MCT in cancer survivors.~   "
75352|NCT02580643|"~     This study will document treatment effects, changes in quality of life, procedure~     complications, adverse events, healthcare resource utilization, and further needed~     intervention(s) following treatment with nSTRIDE autologous protein solution. This study will~     also allow for the documentation of the same parameters following multiple injections of~     autologous protein solution to treat knee osteoarthritis.~   "
75353|NCT02580630|"~     The purpose of this study is to compare in a randomized double blinded controlled trial the~     effect of heavy slow resistance exercises combined with ultrasound guided injections with~     local anesthetic with or without glucocorticosteroid in patients with achilles tendinopathy.~   "
75354|NCT02580617|"~     This is a phase I study to evaluate the safety of ALLO-ASC-CD for the treatment of crohn'~     disease. ALLO-ASC-CD is intravenous infusion containing allogenic adipose-derived mesenchymal~     stem cells.~   "
75355|NCT02580604|"~     Declines in serum calcium during exercise may cause increases in markers of bone resorption.~     This study will determine if preventing the decline serum ionized calcium experienced at the~     onset of exercise through the use of a calcium clamp also prevents increases in blood~     biomarkers associated with bone resorption.~   "
75356|NCT02580591|"~     The study will investigate the efficacy, safety, tolerability and PK of 3 doses of~     empagliflozin compared with placebo over 26 weeks in 960 patients with type 1 diabetes~     mellitus as adjunctive therapy to insulin~   "
75357|NCT02580578|"~     This study will characterize the treatments and outcomes associated with different uterine~     fibroid treatments in Canada, to understand patients' preferences and satisfaction with~     different medical and procedural interventions. The study will also assess the effectiveness~     of ulipristal acetate (Fibristal®) in controlling bleeding, reducing fibroid volume and~     symptoms, and improvement in patient's quality of life.~   "
75358|NCT02580565|"~     The use of analgesics can lead to cases of drug abuse and dependence. It can also cause~     pseudo-addiction in patients suffering from pain. What is the actual situation in patients~     suffering from severe sickle-cell disease, exposed to acute pain during vaso-occlusive~     crises? Evaluation of the use of analgesics, on the basis of Diagnostic and Statistical~     Manual of Mental Disorders criteria for substance abuse and dependence, makes it possible to~     differentiate the symptoms occurring only in a context of pain, in the aim of managing the~     pain, and thus describing pseudo-addiction, from symptoms also occurring when there is no~     pain, and more in favour of true addiction. Currently there is no data available in France on~     this problem, and no studies have been carried out in children or adolescents with~     sickle-cell disease. The purpose of the study is to evaluate the prevalence of problematic~     use of equimolar mixture of oxygen and nitrous oxide and other analgesic drugs in a~     population of subjects with severe sickle-cell disease in France.~      PHEDRE (Pharmacodépendance Et DREpanocytose-drug dependence and sickle-cell disease) is an~     observational, descriptive and transversal study. Patients under the age of 26 with~     sickle-cell disease are included in the study by the doctors looking after them in~     sickle-cell disease centres. The patients are then contacted by a trained researcher for a~     telephone interview, including an evaluation of the Diagnostic and Statistical Manual of~     Mental Disorders criteria for abuse and dependence to equimolar mixture of oxygen and nitrous~     oxide and for each of the analgesic drugs taken by the patient. The data are also completed~     using the subject's medical record.~      This study will make it possible to provide an initial quantitative and qualitative~     evaluation of problematic use of equimolar mixture of oxygen and nitrous oxide and analgesic~     drugs in the sickle-cell disease population. The results will be used firstly to provide~     additional data essential for monitoring the risk of overdose, abuse, dependence and misuse~     of these products, and to begin awareness-raising and to provide information for health care~     professionals, in order to significantly improve the management of sickle-cell~     disease-related pain.~   "
75359|NCT02580552|"~     Objectives of this clinical trial are to evaluate the safety, tolerability, pharmacokinetics~     and potential efficacy of the investigational drug, MRG-106, in patients diagnosed with~     certain lymphomas and leukemias, including cutaneous T-cell lymphoma (CTCL) [mycosis~     fungoides (MF) subtype], chronic lymphocytic leukemia (CLL), diffuse large B-cell lymphoma~     (DLBCL), and adult T-cell leukemia/lymphoma (ATLL). MRG-106 is an inhibitor of a molecule~     called miR-155 that is found at high levels in these types of cancers and may be important in~     promoting the growth and survival of the cancer cells. Participants in the clinical trial~     will receive weekly doses of MRG-106 administered by injection under the skin or into a vein,~     or by injection directly into cancerous lesions in the skin (for CTCL only). Blood samples~     will be collected to measure how MRG-106 is processed by the body, and other measurements~     will be performed to study how normal and cancerous cells of the immune system respond when~     exposed to MRG-106.~   "
75360|NCT02580539|"~     This study evaluates the safety and efficacy of EBV-specific T-cell lines to treat patients~     suffering from high EBV viral titers not responding to standard of care therapies and to~     treat EBV-related lymphoma. The study will recruit 6 patients to receive autologous T cells~     or a T cell line derived from the patient's allogeneic donor (in the case of stem cell~     transplant recipients), and 6 patients to receive a T-cell line prepared from a matched or~     partially matched related donor.~   "
75361|NCT02580526|"~     This study compares the effectiveness of two kinds of two-handed facemask ventilation~     techniques (when breathing is supported with machines) at the time that general anesthesia is~     started. Study participants will start with one technique and then cross over to the other~     technique.~   "
75362|NCT02580513|"~     This study will evaluate the effect of circadian misalignment on insulin sensitivity in~     healthy lean subjects in a randomized cross-over design. Subjects will be admitted to the~     research facility for two study periods of 3 and 3.5 days. In one of the study periods, the~     behavioral cycle will be shifted by 12 hours. Insulin sensitivity will be measured with a~     hyperinsulinemic euglycemic clamp.~   "
75363|NCT02580500|"~     Pilonidal dermoid cyst surgery under general anesthesia and regional anesthesia techniques is~     used.regional anesthesia techniques; spinal, epidural, spinal epidural (combined) and is the~     local anesthesia.In the investigators study, pilonidal dermoid cyst surgery in spinal and~     epidural anesthesia techniques activity, reliability will be compared to the side effects and~     complications.~      One hundred patients will be randomly assigned to either the pilonidal dermoid cyst under~     Spinal anaesthesia (50 patients)(Group 1) or pilonidal dermoid cyst under epidural~     anaesthesia (50 patients)(Group 2). Group 1 will be used in spinal catheter in spinal~     anesthesia procedures or Group 2 will be used epidural catheter in epidural anaesthesia~     procedures.All patients has symptomatic pilonidal dermoid cyst.~   "
75364|NCT02580487|"~     Acute appendicitis is the most common illness that brings pediatric patients to the hospital~     for surgical treatment. Abdominal pain is the symptom because of which the patients go to the~     hospital. Some patients have severe pain and need analgesics before the final diagnosis and~     before surgery. After surgery most patient experience pain and at least 80 % of the patients~     need postoperative pain medication. For two decades there has been a clinical guideline for~     pain management in Kuopio University Hospital (KUH). The investigators aim was to evaluate~     how well the pain management for pediatric patient works in clinical practice.~   "
75365|NCT02580474|"~     Safety and Efficacy of DAAs (Daclatasvir+Asunaprevir) in patients with chronic hepatitis C~     and chronic renal failure will be assessed.~   "
75366|NCT02580461|"~     The RECHARGE study is evaluating the effect of a 24 week structured exercise and education~     program on the physical and emotion health, quality of life, physical activity and fitness~     levels of family caregivers. Very little research has been done examining the impact of a~     structured exercise program designed for family caregivers of cancer patients. The purpose of~     this study is to determine if physical activity is effective in improving caregiver health~     and well-being.~   "
75367|NCT02580448|"~     The goal of this clinical study is to determine the safety, pharmacokinetics,~     pharmacodynamics and efficacy and activity of seviteronel, a lyase-selective inhibitor of~     CYP17, in patients with advanced breast cancer.~   "
75388|NCT02580175|"~     The abortion considers the most common cause of fetal demise all over the world. The majority~     of cases occur in the first trimester.The termination of abortion may be by medical or~     surgical methods, however; the surgical methods represents the greater part of termination.~     Therefore, the safety of this procedure is a worldwide public health concern . Many clinical~     studies have been reported the safety of surgical evacuation in the first trimester.~      The suction-aspiration or vacuum aspiration are the most common surgical methods of induced~     abortion. This consists of removing the fetus, embryo, placenta, and membranes by suction~     using a manual syringe or electric pump. However; these technique always need cervical~     dilation before aspiration. The menstrual extraction does not require cervical dilation and~     can be used in very early pregnancy.~      The surgical evacuation is generally considered safe, however; short-term complications are~     reported due to need of dilatation of the cervix and incomplete evacuation because the~     surgeon is the only one who can decide the end of the operation depending on his subjective~     sense.~      However; with continuous ultrasound guidance, the process could be almost complete because~     the ultrasound can accurately identify the direction and size of the uterus, position of the~     gestational sac, observe the insertion of surgical instruments and the advancement of the~     operation especially when the configuration of the uterus is distorted.~      At present; ultrasonography is not considered to be an essential pre-requisite for abortion~     in all cases so our study aims to detect if complete evacuation can be achieved by~     ultrasonographic assistance or not. We also tried in this study to compare the operative~     time, amount of blood loss and the occurrence of accidental uterine perforation during the~     procedure with and without use of ultrasound.~   "
75368|NCT02580435|"~     Multiple sclerosis (MS) is an inflammatory disease that affects the nervous system and~     results in a wide range of signs and symptoms including physical and cognitive problems.~     Recent evidence demonstrates that interactions between the host immune system and the~     commensal gut microbiota have a key role in the development of the disease. However, the~     natures of these interactions are poorly studied, and the set of bacteria with pathogenic or~     protective potential are unknown. Here, the investigators propose a multi-pronged approach to~     deciphering the role of the microbiota in MS, by developing microbiome-based machine learning~     algorithms aimed at: (1) distinguishing healthy individuals from MS patients; (2) predicting~     the time since the onset of MS in relation to disease activity by predicting next relapse and~     neurological progression; (3) identifying microbiome signatures that characterize the relapse~     state; (4) distinguishing various MS phenotypes in relation to blood and microbiome~     transcriptome signatures; (5) predicting response to various immunomodulatory treatments in~     relation to blood and microbiome transcriptome signatures. Overall, these studies should~     establish the role of the microbiome in multiple sclerosis, resulting in a set of~     non-invasive tools for characterization of the disease; identification of the kinetics of MS~     using microbiome as a readout; and allowing the prediction of individuals prone to MS based~     on their microbiome and in relation to their protein expression. These new set of diagnostic~     and predictive tools may thus add a novel and unexplored dimension to the study of the~     disease that may lead in the future to new therapeutic avenues based on designing~     microbiome-targeted interventions.~   "
75369|NCT02580422|"~     Cachexia is a systemic catabolic syndrome with apparent effect on skeletal muscles, tolerance~     to chemotherapy, early toxicity and quality of life; however, its effect on cardiopulmonary~     function is not well understood. Preclinical studies demonstrated diaphragmatic muscle~     wasting(29) and left ventricular wasting and fibrosis associated with mouse cachexia~     models.(40) Many patients, who experience cancer cachexia, describe a generalized debility~     and a sense of breathlessness(41) despite adequate oxygenation in the peripheral blood as~     measured by pulse oximetry. Whether this is related to deconditioning associated with~     chemotherapy or related to direct effect on cardiac and diaphragmatic muscles remains~     unknown. In this pilot study, the investigators propose to perform a preliminary evaluation~     of the cardiopulmonary function in patients with pancreatic cancer, who are likely to develop~     cachexia, to assess for the feasibility of performing a larger prospective study to~     understand the impact of cancer cachexia on cardiopulmonary function. This pilot study will~     provide the foundation to potentially identify cachexia in early stages (pre-cachexia) to~     develop pharmacological or exercise based interventions to prevent or delay its progression.~     Based on clinical experience and published literature, it is expected that 60-70% of patients~     will have >10% weight loss during the course of this disease. More commonly, this is~     associated with clinical or radiographic disease progression, but certainly it can happen~     throughout the course of the disease even without disease progression.~   "
75370|NCT02580409|"~     Rehabilitation Enhancing Aging through Connected Health, REACH, is designed to evaluate the~     benefits of a novel rehabilitative care program on physical function utilizing mobile health~     technology to deliver patient centered care more efficiently and health care utilization~     after one year of follow up.~   "
75371|NCT02580396|"~     This feasibility study will be conducted in order to provide proof of concept for the~     CanADVICE+® system comprising a smart phone app and a healthcare organization server side~     application based on Web 2 technologies. The main objective of this project is to optimise~     pharmaceutical counselling services by providing drug related information, in a digital~     format, to patients with metastatic breast cancer receiving Capecitabine.~   "
75372|NCT02580383|"~     The investigators collected data and chart from the patients who were diagnosed facet joint~     syndrome and underwent lumbar RF medial branch neurotomy between January 2009 and June 2014.~      RF was performed using sensory stimulation and multifidus twitching to confirm the position~     of RF needle. The patients wil be grouped according to the adequacy of RF needle position~     while performing RF medial branch neurotomy ('complete' when all needles were placed~     adequately, 'partial' when one of the needles for a facet joint medial branch was placed~     inadequately, 'none' when there were both needles positioned inadequately for a facet joint)~     The relationship between the long term effect of RF neurotomy (longer than 6 months) and the~     groups will be analyzed.~   "
75373|NCT02580370|"~     This is a safety and efficacy study of botulinum toxin type A in subjects with lateral~     canthal lines.~   "
75374|NCT02580357|"~     The aim of this study was to compare two intensities of LLLT on wound healing process of the~     donor palatine area after CTG removal.~   "
75375|NCT02580344|"~     The Copper intrauterine device is the most common method of reversible contraception~     worldwide. Abnormal uterine bleeding and pain are the most common medical indications for the~     discontinuation of the intrauterine device.~      Excessive prostaglandin release in the endometrial cavity appears to play an important role~     in both bleeding and pain related to copper intrauterine devices.There are many types of~     prostaglandin metabolites that present in the endometrium one of them is prostacyclin which~     causes vasodilatation and inhibits platelet aggregation. Another one is thromboxane which has~     two types; A2 which is active and rapidly converted into B2, which is inactive. Thromboxane~     causes vasoconstriction and blood clotting.~      Non-steroidal anti-inflammatory drugs (NSAIDs) are prostaglandin synthetase inhibitors acting~     by decreasing production of endometrial prostaglandins; they can improve both heavy uterine~     bleeding and pain. Since its discovery; several drugs in NSAIDs class have been used to treat~     heavy uterine bleeding and pain associated with copper intrauterine device use such as~     mefenamic acid, ibuprofen and naproxen.~      The most recent systematic review found NSAIDs is the most widely studied drugs for reduction~     of the menstrual blood and pain associated with copper intrauterine device. The Cochrane~     Review also found that NSAIDs are the most effective treatment to reduce the bleeding with~     copper intrauterine device use.~   "
75376|NCT02580331|"~     Metformin (MF), a biguanide group of anti-diabetic drug has been shown to enhance osteoblasts~     differentiation and inhibit osteoclast differentiation in vitro, thus may exhibit a~     favourable effect on alveolar bone. The present study aims to explore the efficacy of 1% MF~     gel as a local drug delivery system in adjunct to scaling and root planing (SRP) for the~     treatment of Class II furcation defects in comparison with placebo gel.~   "
75377|NCT02580318|"~     This is a prospective cohort study. The investigators will enroll 50 healthy volunteers. In a~     safe environment and after signing informed consent, each participant will consume a~     standardized alcoholic beverage. Using a Breathalyzer, the subjects BAT will be measured. If~     the subject's BAT is less than 0.10 +/- 0.005, the subject will drink another alcoholic~     beverage. This process will continue until the subject's BAT is 0.10 +/- 0.005. The number of~     alcoholic beverages the subject consumes will be monitored by the observers. When the target~     BAT is reached, the subjects will manipulate the breathalyzer in various ways and measure~     their BAT again after each manipulation. In a set order, the subjects will manipulate the~     breathalyzer by using less than the subject's maximal exhalation effort, placing the~     breathalyzer at the side of the subject's mouth, hyperventilating (10 rapidly (less than 1~     second) and successive breaths prior to using the device), repeating breathalyzer 5 minutes~     and 10 minutes after hyperventilation and then drinking cold water after the breathalyzer at~     10 minutes and repeating the breathalyzer after drinking some cold water. Descriptive~     statistical analyses as well as Pearson's product moment correlation coefficient will be~     employed to determine if any statistically significant correlation exists for any of the~     manipulations.~   "
75378|NCT02580305|"~     This is a phase 2a, proof-of-concept, 26-week, double-blind, multicenter, randomized,~     parallel group, placebo-controlled study to compare the efficacy and safety of treatment with~     SUVN-502 to placebo treatment in subjects with moderate Alzheimer's disease receiving stable~     doses of donepezil HCl and memantine HCl.~   "
75379|NCT02580292|"~     To determine if ultrasound measurement of renal and carotid arterial resistive indices are~     associated with post-cardiac surgery acute kidney injury.~   "
75380|NCT02580279|"~     The investigators conduct this phase II study of EGCG therapy protection of the skin from~     damage induced by radiotherapy in breast cancer. In order to observe the effectiveness of~     EGCG, investigators will utilize both clinician assessments and patient self-assessments.~     Physician's skin assessments will be scored utilizing the Radiation Therapy Oncology Group~     (RTOG) score. Patient reported symptom scores are adapted from the Skin Toxicity Assessment~     Tool (STAT) as pain, burning, itching, pulling, and tenderness in the treatment area. The~     scales are translated into Chinese and guides in Chinese are developed instructing how to use~     the scales and perform the assessments.~   "
75381|NCT02580266|"~     Diabetic nephropathy (kidney problems caused by diabetes) is a devastating chronic vascular~     complication of diabetes. New treatments are urgently needed for preventing or slowing down~     the progression of diabetic kidney disease. Samples of serum/plasma/urine will be obtained~     from patients with diabetes and different degree of renal impairment.~      In this project cells in culture will be treated with plasma or serum or urine; cells~     extracts or supernatant will be studied to screen for modulation (activation/inhibition) of~     different cellular pathways using gene array, metabolomic and/or proteomic. Once some~     cellular pathways have been identified specific analysis will be conducted on the biological~     material collected to confirm specific cell signatures that could represent potential~     target for treatment.~   "
75382|NCT02580253|"~     This study is a randomized, open-label, controlled study that will explore the efficacy of~     individualized adjuvant chemotherapy based on the adenosine triphosphate tumor~     chemosensitivity assay for patients with hepatocellular carcinoma after liver~     transplantation.~   "
75383|NCT02580240|"~     The purpose of this study : 1）to determine whether hydrocortisone is effective in the~     treatment of septic shock and 2) to identify the role of timing of low dose hydrocortisone~     administration in septic shock patients.~   "
75384|NCT02580227|"~     The objective of this study is to evaluate the effect of Tranexamic Acid (TXA) on blood loss~     and need for perioperative blood transfusion following intertrochanteric and subtrochanteric~     femur fractures. TXA is a antifibrinolytic medication that prevents the breakdown of blood~     clots by inhibiting the activation of plasminogen to plasmin in the coagulation cascade. Our~     hypothesis is that by providing TXA at the time of hospital admission it will decrease the~     amount of preoperative and intraoperative bleeding thereby leading to a decreased need for~     post-operative transfusion. This a double blinded, placebo controlled, therapeutic trial in~     which half of patients will be randomized to receive TXA at the time of hospital admission~     and half of patients will receive a placebo.~   "
75385|NCT02580214|"~     The aim of this pilot study was to investigate whether the use of a multimodal protocol of~     preoperative care plus preoperative immune nutrition would decrease the length of stay and~     acute phase inflammation in patients submitted to total hip arthroplasty (THA). The study was~     designed to be randomized and controlled, but not double blind. The patients were randomized~     to receive either preoperative care based on evidence plus immune nutrition for 5 days prior~     to surgery (Acerto group) or traditional preoperative care (control group). Main endpoints~     were length of stay and acute-phase postoperative response~   "
75386|NCT02580201|"~     The purpose of this study is to assess the safety (serious adverse events [SAEs]), and severe~     adverse events [AEs] (grade 3 according to CTCAE 4.03) after one dose of SABIN tOPV in 1-5~     year-old children and three doses of SABIN tOPV in 6 week-old infants, and immunogenicity~     (seroprotection rates for all 3 serotypes) 28 days after three doses of SABIN tOPV in~     vaccine-naïve infants.~   "
75387|NCT02580188|"~     This study is a randomized, controlled, double-blinded, and parallel design study. A total 96~     patients were randomized to receive a deep block or a moderate block scheduled for elective~     laparoscopic colorectal surgery. Investigators estimated the proportion of intra-abdominal~     pressure(IAP) alarm and surgical rating score.~   "
75389|NCT02580162|"~     This study evaluates and compares the efficacy of professional versus peer-based delivery of~     family-based treatment for childhood overweight and obesity in elementary school aged~     children. Families will be randomized to receive treatment from professionals or to receive~     treatment from professionally-trained peer interventionists. Some parents will then be~     invited to serve as peer interventionists for the next group of families.~   "
75390|NCT02580149|"~     To investigate if treatment with ticagrelor can mitigate the transient loss of~     endothelium-dependent vasodilatation of the resistance vasculature following a short period~     of ischemia, compared with clopidogrel at standard clinical doses. The effect of ticagrelor~     or clopidogrel will be studied after a loading dose and after a two weeks period of regular~     intake on FBF in response to the vasodilators acetylcholine or nitroglycerin before and 10~     min after a 20 min forearm ischemia, respectively.~   "
75392|NCT02580123|"~     The importance of families in the development of infants is well documented. Previous studies~     found that the prevalence of overweight and obesity is growing concerns in Portugal (Padez,~     Fernandes, Mourão, Moreira, & Rosado, 2004) and in the world (Ogden et al., 2014). More,~     there is evidence that habits acquired in early life might track into adulthood (Lien, Lytle,~     & Klepp, 2001; Lytle, Seifert, Greenstein, & McGovern, 2000; te Velde, Twisk, & Brug, 2007).~     Therefore, there is a need to lock overweight and obesity in early childhood in order to~     contribute to health gains during the entire life cycle. The main purpose of this research is~     to evaluate the impact of an intervention program based on parenting skills and feeding~     practices, on infant's growth, development and adherence to new foods in early infancy~      Methods: 58 infants, 4-12 months from 25 nursery schools participated in this randomized~     trial and were randomly allocated to intervention and control group. Infant outcomes were~     performed at baseline and post-intervention and included anthropometry, dietary assessment~     and temperament. In addition maternal and family outcomes such as anxiety, dietary intake~     were also assessed at both times.~      An intervention program was developed and Implemented according to two terms: educators'~     training with the researchers and the intervention with parents and infants developed by~     trained educators. The training program was developed between December 2013 and February~     2014, according to the topics of healthy eating and nutrition and development of the infant.~     The control group received the standard care.~      It is expected that this intervention program is able to promote healthy feeding practices to~     parents and nursery teachers. The results will be disseminated to the stakeholders and~     policymakers that work closely to the topic of this study. This will include papers'~     publication, participation in national and international meetings, contributing to the~     advance of research in this health area.~   "
75393|NCT02580110|"~     The study intention is to investigate, in healthy humans, effects of 3 commonly used~     sweeteners on cardiometabolic risk markers, cognitive functions, and influences on gut~     microbiota composition.~   "
75394|NCT02580097|"~     To explore Magnetic Resonance(MR) perfusion imaging as a biomarker to predict outcome of~     patients with acute and subacute stroke. Contrast bolus perfusion imaging and arterial spin~     labeling were conducted in included patients. Imaging evaluation of hemodynamic status,~     collateral and antegrade flow were assessed. Patients were followed up to record radiological~     and clinical outcome.~   "
75395|NCT02580084|"~     Currently, according to the TASC II consensus document (2007) and the Russian guidelines for~     limb ischemia treatment (2010), aorta-iliac C and D type segment lesions the open surgery is~     suggested.~   "
75396|NCT02580071|"~     The treatment options for high-risk acute leukemia patients are limited and these patients~     are often opt for hematopoietic stem cell transplant (HSCT). However studies show that~     prognosis following this last-resort therapy is bleak. At times, less than 70% of post-HSCT~     relapsed AML and ALL patients even achieve complete remission; median overall survival of~     these cohorts might not reach one year; and 3-year post-HSCT survival rates might be less~     than 20%.~      The investigators plan to recruit acute leukemia patients from CMUH which are planned to~     receive HSCT, and follow the rate and quality of their immune reconstitution. As~     intervention, part of the patients will receive a Chinese medicine herbal formula, which they~     will take for 6 months.Differences between the 1-year post-HSCT condition of patients will be~     examined.~   "
75397|NCT02580058|"~     A Phase 3 global study comparing avelumab alone to avelumab plus PLD and to PLD alone to~     demonstrate that avelumab given alone or in combination with PLD is superior to PLD alone in~     prolonging Overall Survival in patients with platinum resistant/platinum refractory ovarian~     cancer.~   "
75398|NCT02580045|"~     This clinical trial is being done to learn more about how different types of cancer~     treatments affect cancer cells when they spread to the brain. Many cancer treatments are not~     able to make their way into the brain or into spinal fluid of the central nervous system.~     This is because they cannot cross what is called the blood-brain barrier or BBB. The BBB~     is like a protective shield that only allows certain materials pass through to reach the~     brain but not others. This study is being initiated to help researchers learn more about what~     types of cancer treatments make it through the BBB to attack cancer cells within the brain,~     and what treatments do not make it through the BBB. Learning more about this may help future~     researchers develop more effective cancer drugs that better fight cancer cells that have~     spread to the brain.~   "
75399|NCT02580032|"~     This study is conducted in Europe and the United States of America (USA). The aim of the~     study is to validate two measures for growth hormone deficiency in children, the Treatment~     Related Impact Measure of Childhood Growth Hormone Deficiency (TRIM-CGHD) and the Treatment~     Burden Measure of Childhood Growth Hormone Deficiency (TB-CGHD).~   "
75400|NCT02580019|"~     The study aims at estimating the safety and efficacy of the intravenous injection of human~     umbilical cord mesenchymal stem cell(hUC-MSC) for patients suffering from ischemic stroke in~     recent 3 months.~   "
75401|NCT02580006|"~     This Phase I study is to compare pharmacokinetics, safety and pharmacodynamics of EPORON and~     EPREX after single subcutaneous administration.~   "
75402|NCT02579993|"~     In this study the prognostic value of ABCB5 in survival of the limbal stem cell~     transplantation expanded in vitro on amniotic membrane for corneal surface reconstruction in~     patients with limbal stem cell deficiency will be analyzed.~   "
75403|NCT02579980|"~     Unless a cancer quickly gets smaller with radiation or chemotherapy, the investigators cannot~     tell if the treatment is working or not. In this research program, two techniques using~     magnetic resonance imaging (MRI) scanning will be tested in people who have sarcomas, which~     are rare cancers starting in muscle, tendons, and bones. These particular MRI tests are~     called dynamic contrast enhanced MRI and diffusion weighted MRI. These MRI scans allow~     visualization of how sarcomas are different from the normal organs of the body. These MRI~     tests will tell us the location of sarcoma and its proximity to other structures, as well as~     correlation of imaging with pathological characteristics after surgery~   "
75427|NCT02579668|"~     In the United Kingdom, the language of the Deaf community is British Sign Language (BSL). A~     small proportion of Deaf young people who use BSL as their first or dominant language have~     specific language difficulties and would benefit from language therapy provided in sign~     language by adults who are fluent in BSL and may be Deaf. Some Deaf adults are currently~     employed in education and health services to support children's BSL development. However~     there is little training or information available to these adults about language assessment,~     diagnosis of language difficulties or intervention strategies.~      Recent studies have highlighted language difficulties and therapy in sign as an issues and~     begun to explore Deaf adults understanding of language difficulties and disorder. This~     project aims to extend knowledge in this area by supporting Deaf practitioners to understand~     and develop language therapy skills and co-develop language therapy intervention resources.~     The study will pilot training for practitioners and language therapy interventions for young~     people.~   "
75404|NCT02579967|"~     Background:~      Allogeneic blood or marrow transplant is when stem cells are taken from one person s blood or~     bone marrow and given to another person. Researchers think this may help people with immune~     system problems.~      Objective:~      To see if allogeneic blood or bone marrow transplant is safe and effective in treating people~     with primary immunodeficiencies.~      Eligibility:~      Donors: Healthy people ages 4 or older~      Recipients: People ages 4-75 with a primary immunodeficiency that may be treated with~     allogeneic blood or marrow transplant~      Design:~      Participants will be screened with medical history, physical exam, and blood tests.~      Participants will have urine tests, EKG, and chest x-ray.~      Donors will have:~      Bone marrow harvest: With anesthesia, marrow is taken by a needle in the hipbone.~      OR~      Blood collection: They will have several drug injections over 5-7 days. Blood is taken by IV~     in one arm, circulates through a machine to remove stem cells, and returned by IV in the~     other arm.~      Possible vein assessment or pre-anesthesia evaluation~      Recipients will have:~      Lung test, heart tests, radiology scans, CT scans, and dental exam~      Possible tissue biopsies or lumbar puncture~      Bone marrow and a small piece of bone removed by needle in the hipbone.~      Chemotherapy 1-2 weeks before transplant day~      Donor stem cell donation through a catheter put into a vein in the chest or neck~      Several-week hospital stay. They will take medications and may need blood transfusions and~     additional procedures.~      After discharge, recipients will:~      Remain near the clinic for about 3 months. They will have weekly visits and may require~     hospital readmission.~      Have multiple follow-up visits to the clinic in the first 6 months, and less frequently for~     at least 5 years.~   "
75405|NCT02579954|"~     Pulmonary Arterial Hypertension is characterized by a progressive increase in pulmonary~     vascular resistance inducing shortness of breath and exercise intolerance. We aim to~     correlate cardiac function (evaluated at rest by right heart catheterism and RMN) to exercise~     capacity (evaluated by endurance time at 75% of maximal workout), in prevalent patients with~     pulmonary arterial hypertension, and their evolution at three and twelve months.~   "
75406|NCT02579941|"~     Pregnancy induces a physiological change of hemostasis to a prothrombotic state : protein S~     decrease and increase of virtually all the clotting factors, in particular fibrinogen, von~     Willebrand factor and factor VIII. However, a state of hyperfibrinolysis may occur in the~     immediate postpartum period (especially after placental delivery), thereby promoting~     postpartum hemorrhage.~      This state of hyperfibrinolysis is associated with the use of transfusions of blood products~     and the realization of hysterectomy.It is currently the most common etiology of maternal~     mortality in childbirth.There is an imperative to develop an efficient and reliable protocol~     for the management of this postpartum complication.~      Tranexamic acid is an anti-fibrinolytic agent (like lysine) which acts by preventing the~     conversion of plasminogen to plasmin, by blocking the binding of plasminogen to the heavy~     chain of fibrin.The optimal dose of tranexamic acid enabling to inhibit fibrinolysis without~     increasing the complications rate remains to be defined. It is in this context that the~     investigators aim to evaluate, in an in-vitro model, the minimum dose of tranexamic acid~     required to inhibit fibrinolysis after activation of the latter by t-PA. The degree of~     fibrinolysis will be evaluated by thromboelastometry.~   "
75407|NCT02579928|"~     The purpose of this study is to determine the tolerability and short-term efficacy of a~     single ketamine infusion for the treatment of adolescents with 1) medication-refractory major~     depressive disorder (MDD) and/or 2) medication-refractory anxiety disorders (social anxiety~     disorder, panic disorder, generalized anxiety disorder and/or separation anxiety disorder).~   "
75408|NCT02579915|"~     The purpose of the study is to develop a personalized, user-friendly computerized treatment~     for anxiety disorders linked to primary care. The computerized treatment is a type of~     Cognitive Bias Modification, which targets attention and interpretation biases known to~     maintain anxiety disorders.~   "
75409|NCT02579902|"~     The purpose of this study is to determine whether vitamin D3 supplementation is effective in~     the treatment of clinical signs, biomarkers of inflammation and oxidative stress due to~     Irritable Bowel Syndrome (IBS).~   "
75410|NCT02579889|"~     The study is designed as a multi-center, international, prospective, parallel, randomized,~     single blinded trial comparing the time to first primary endpoint event (Sustained Paroxysmal~     AF/Persistent AF or stroke/TIA) occurrence in a follow up period of 3 years, between Closed~     Loop Stimulation (CLS) ON versus OFF, on top of a DDD pacing in patients with pacemaker or~     ICD indication who require dual-chamber pacing due to sinus node disease (SND), with or~     without atrioventricular (AV) block.~   "
75411|NCT02579876|"~     This is a single-site, double-blind, placebo-controlled, randomized trial to study efficacy~     and safety of the Viaskin® Milk Patch for children with milk induced Eosinophilic Esophagitis~     (EoE). 20 subjects will be randomized 3:1 to Viaskin® Milk or placebo patch.~   "
75412|NCT02579863|"~     The purpose of this study is to compare the efficacy of lenalidomide and low dose~     dexamethasone with pembrolizumab (MK-3475) to that of lenalidomide and low dose dexamethasone~     without pembrolizumab in terms of progression-free survival (PFS) in participants with newly~     diagnosed and treatment-naïve multiple myeloma who are ineligible for autologous stem cell~     transplant (Auto-SCT).~   "
75413|NCT02579850|"~     The aim of the present study is to evaluate the superiority of the fixed triple therapy with~     BDP/FF/GB at a daily dose of 400/24/50 mcg respectively with that of Ultibro® Breezhaler®~     (DPI), fixed combination of indacaterol 85 mcg and of glycopyrronium 43 mcg in COPD patients.~   "
75428|NCT02579655|"~     The purpose of this study is to determine the effect of two novel interventions; (1) a~     value-based formulary which eliminates copayment for selected high-value medications (proven~     to prevent heart attacks, stroke, and hospitalizations); and (2) a comprehensive patient~     education program aimed at lifestyle modification and optimal drug use, combined with relay~     of information on medication use, on the risk of adverse clinical outcomes (mortality, heart~     attack, stroke, need for coronary revascularization, and chronic disease related~     hospitalizations) in low-income seniors with chronic conditions over three years.~   "
75465|NCT02579148|"~     The intent of this clinical study is to answer the questions: 1) is the proposed treatment~     feasible; 2) is treatment effective in improving the disease pathology of patients with~     diagnosed diabetic erectile dysfunction.~   "
75603|NCT02577354|"~     The purpose of this trial is to evaluate the safety and efficacy of ReActiv8 for the~     treatment of adults with Chronic Low Back Pain and no prior spine surgery when used in~     conjunction with medical management.~   "
75414|NCT02579837|"~     Diabetic eye disease causes major vision loss in many Canadians and is costly. There are~     effective preventions and treatments for diabetic eye disease but they strongly depend upon~     regular screening in asymptomatic patients. The 2013 Canadian Diabetes Association (CDA)~     guidelines recommend annual screening by eye care professionals, either in-person or through~     interpretation of dilated pupil retinal photographs.~      Despite the benefits of screening, adherence to these guidelines is poor. Reasons include~     patient barriers, i.e. need for eye drops, time off work, wait times, and transportation~     issues. An option to minimize these barriers is to screen using a camera called non-mydriatic~     ultra-widefield (UWF) retinal imaging. This can be quickly done without eye drops on the same~     day as patients' regularly scheduled diabetes clinic visits.~      In this study, the investigators will compare the UWF camera to the usual screening approach~     recommended by the CDA. The investigators will invite 740 patients with diabetes due for eye~     screening to either be screened using the UWF camera on the day of their diabetes clinic~     visit or be screened by their usual eye care professional. The investigators' prediction is~     that same-day screening with UWF imaging will find more patients with diabetic eye disease~     who need treatment compared to usual screening.~   "
75415|NCT02579824|"~     This is a 2 part study: Part 1 (dose escalation) and Part 2 (dose expansion).~      The goal of Part 1 of this clinical research study is to find the highest tolerable dose of~     DS-3032b that can be given to patients with multiple myeloma (MM) that is relapsed (has come~     back) and/or refractory (has not responded to treatment).~      The goal of Part 2 of this clinical research study is to continue to study the safety of the~     highest tolerable dose found in Part 1 of the study.~   "
75416|NCT02579811|"~     Axitinib is a drug which is approved by the FDA for patients with advanced kidney cancer who~     have already received some treatment. It works by reducing blood flow to a tumor. Axitinib is~     normally give at 5mg twice per day and sometimes this dose is increased if patients tolerate~     it. The purpose of this study is to figure out a different way to decide which dose of~     axitinib each patient should receive based on the side effects they experience.~   "
75417|NCT02579798|"~     General anesthesia, even in patients in good health, impairs gas exchanges and ventilatory~     mechanics. These effects result primarily from atelectasis formation. They occur in 85-90% of~     healthy patients in the minutes following the induction when a positive end expiratory~     pressure (PEEP) is not used.~      The functional residual capacity (FRC) of obese patients during general anesthesia is even~     smaller than the one of healthy patients. There is a direct relationship between the body~     mass index and the decrease of the functional residual capacity. Obese patients have~     therefore more atelectasis. The increased abdominal pressure during the pneumoperitoneum will~     increase the decrease of the CRF, and thus aggravate the formation of these atelectasis.~      Atelectasis affect the peroperative gas exchanges and are likely to be involved in the~     worsening of postoperative hypoxemia episodes. In addition, atelectasis alter the clearance~     of secretions and the lymph flow, which predispose to lung infections.Taking all these~     factors into account, it is logical to think that the atelectasis presence can lead to an~     increase of the postsurgical morbidity (respiratory distress, infections). That is why~     actively fighting against the formation of these atelectasis is important.~      There is a lack of scientific evidence to say that the strategies against atelectasis as PEEP~     have a significant impact on the patient's postoperative status. The expected clinical~     benefits balance (reduction of respiratory distress episodes, infections and mortality)~     versus the risks linked to the maneuvers done to reduce the development of atelectasis~     (barotraumas, cardiac complications) remains to be determined.~      The primary goal of this study is to evaluate the impact of two different alveolar~     recruitment strategies on the incidence of postoperative hypoxemia in obese patients after~     bariatric surgery.~      The secondary objectives of this study are to compare the number of recruitment maneuvers,~     the Pa02 / FI02 ratio (ratio of arterial oxygen partial pressure to fractional inspired~     oxygen), the dynamic compliance, the anatomic dead space and intraoperative PaCO2-EtCO2~     gradient (arterial and end tidal gradient) between two alveolar recruitment strategies~     applied in obese patients during laparoscopic bariatric surgery (gastric bypass or sleeve~     gastrectomy).~      The tertiary objectives of this study are to report the number of respiratory complications~     and postoperative wound infections at the 30th postoperative day.~   "
75418|NCT02579785|"~     The purpose of this study is to assess whether a mobile phone intervention can be effectively~     used to improve post menstrual regulation contraceptive uptake and continuation in~     Bangladesh.~      The study will consist of two phases: Phase I: A formative phase to understand barriers to~     post-abortion contraceptive uptake and continuation and the content and modality of messages~     most appropriate for women in the study areas; and Phase II: An RCT will be conducted to test~     the effectiveness of the mHealth intervention developed during the formative phase on~     contraceptive use.~   "
75419|NCT02579772|"~     The main purpose of this study is to determine whether pharmacological treatment with~     N-acetylcysteine improves central and peripheral cardiorespiratory control and physical~     capacity in COPD patients with mild-to-moderate airflow obstruction.~   "
75420|NCT02579759|"~     The purpose of this study is to determine whether PXT3003 is effective and safe in the~     treatment of Charcot-Marie-Tooth disease - Type 1 A (CMT1A). This double-blind study will~     assess in parallel groups 2 doses of PXT3003 compared to Placebo in CMT1A patients treated~     for 15 months.~   "
75421|NCT02579746|"~     The study examined the feasibility of the Dietary Approach to Stop Hypertension with Sodium~     (Na) Reduction for Chinese Canadian (DASHNa-CC) intervention and its potential effects on~     blood pressure, health-related quality of life, and health service utilization. Half of~     participants received usual care while the other half received the DASHNa-CC intervention.~   "
75422|NCT02579733|"~     The aim of this study is to determine whether azathioprine is effective for mucosal healing~     in UC patients who achieved clinical remission by the first course of corticosteroids but not~     mucosal healing in endoscopy.~   "
75423|NCT02579720|"~     The purpose of this non interventional study (NIS) was to observe the efficacy of Pollinex®~     Quattro as a short-term revaccination in patients who have already been successfully~     desensitized at least five years ago against grass-pollen but developed a recurrent allergy.~   "
75424|NCT02579707|"~     This will be a 2-part study. PART 1 is an open-label, randomized, food effect study of~     AG-120. Subjects will be enrolled to a fed/fasted or fasted/fed treatment sequence in a~     2-period crossover design. PART 2 is an open-label study to determine the safety and PK~     parameters of a single 1000-mg oral dose of AG-120.~   "
75425|NCT02579694|"~     The purpose of this retrospective-prospective clinical evaluation is to determine whether the~     SLIC Screw System provides provisional fixation to allow biological healing of the~     scapholunate interval.~   "
75426|NCT02579681|"~     The primary objective(s) of the study are to assess the BG00012 (dimethyl fumarate) treatment~     effect on cognition over 2 year period in RRMS patients. The secondary objectives of this~     study are to further assess BG00012 treatment effect on cognition, predictors of cognitive~     impairment, clinical efficacy, and patient reported outcomes (PRO): depression, fatigue,~     quality of life, and work and social life activity.~   "
75604|NCT02577341|"~     This Phase II randomized study is to determine the efficacy and toxicity of Nimotuzumab in~     combined with chemoradiotherapy for unresectable,local advanced squamous cell lung cancer.~   "
75429|NCT02579642|"~     Ketamine has been used successfully as the sole medication for anesthesia in the setting of~     electroconvulsive therapy (ECT), and has more recently been studied as an adjunct agent in~     combination with propofol (the most commonly used anesthetic agent) to induce anesthesia for~     ECT. New literature postulates an anti-depressant effect of ketamine, which in ECT~     specifically may be helpful with regards to the overall goals of therapy (i.e. ECT indicated~     for severe or treatment-resistant depression).~      Current research focusing on ketamine with respect to its anti-depressant effect suggests it~     may even represent an alternative to ECT. This study will seek to determine whether ketamine~     when used in low-doses as an adjunct to propofol-based anesthesia for ECT has anti-depressant~     effects and whether it influences the characteristics of recovery from anesthesia in the ECT~     setting (i.e. vital sign parameters such as blood pressure and heart rate, quality of~     recovery, etc.).~   "
75430|NCT02579629|"~     The main purpose of this study is to examine if pain levels treated with intrathecal (IT)~     preservative-free morphine (PFM) after a cesarean section improve with the additional use of~     continuous subfascial wound infiltration with ropivacaine using the OnQ® elastomeric pump~     system.~   "
75431|NCT02579616|"~     This is a multicenter, single arm, open-label study in participants with unresectable BTC and~     disease progression or failure following one prior gemcitabine-based doublet chemotherapy~     regimen (combination of gemcitabine and cisplatin, or gemcitabine and other platinum~     agent/fluoropyrimidine agent). This study contains 3 phases: a Pre-treatment phase that will~     last within 21 days; a Treatment phase that will consist of study treatment cycles and tumor~     assessment conducted every 6-8 weeks; and a Follow-up phase that will begin immediately after~     the Off-Treatment Visit and will continue as long as the participant is alive, unless the~     participant withdraws consent, or until the End of Study.~   "
75432|NCT02579603|"~     This is a phase IV, twelve week, open label, randomized, parallel group study to assess~     safety and tolerability of combined treatment with nintedanib and pirfenidone.~      A secondary objective is to assess the exposure based on PK trough concentration values to~     nintedanib either given alone or in combination with pirfenidone and to assess the exposure~     of pirfenidone when combined with nintedanib.~   "
75433|NCT02579590|"~     Female sexual dysfunction is age-related, progressive, and very common condition. The~     physiology of the female sexual function is a complex condition affected by emotional,~     medical and hormonal elements.~      Progestogen-only contraception relies on progestogens alone to achieve contraception. There~     are several progestogen only contraceptive methods include progestogen only pill (minipill),~     subdermal implants, Depo-Provera (DMPA) and levonorgestrel intrauterine system. Many studies~     in literature reported the negative effect of combined oral contraceptive pills (COCs) on~     female sexual function due to decrease in bioavailability of testosterone and increase level~     of sex hormone binding globulin (SHBG) which leads to decrease in free testosterone level~     contributes to dysfunction.~      However, the progesterone only methods contains no estrogen, so it has less effect on sex~     hormone binding globulin and therefore less effect on free testosterone. DMPA (injectable~     progestins) is an injectable progestin is a highly reliable form of contraception. Nelson in~     1996 found that about 6% of women using DMPA reported either lost or decreased libido. More~     recent study by Fortenberry in 2011 reported that DMPA had no effect on sexual interest~     compared with nonusers of any hormonal method of contraception in an adolescent population.~     The etonogestrel implant (Implanon) is a single rod that is inserted into the medial side of~     non dominant upper arm. Although in general, it is very effective and has relatively low side~     effect, a decreased libido has been noted.~      Cerazette is a progestogen-only contraceptive pill containing 75 micrograms of desogestrel.~     It acts mainly by inhibiting ovulation. Cerazette users also may complain of decreased~     libido.~      The estrogen is the main hormone which responsible for vitality of the pelvic organ~     especially the vagina. The main mechanism of action of the DMPA, Implanon and Cerazette is~     inhibition of ovulation, which leads to decrease in the estrogen level, which causes a drop~     in blood flow in uterine artery and accordingly the vagina artery. That can affect vaginal~     lubrication, causing the vagina to be too dry for comfortable sex.~   "
75434|NCT02579577|"~     The population of children with life-limiting illnesses (LLI) in England is increasing and~     there is growing need to improve the quality of children's palliative care. Families of~     children with LLI are confronted with many care decisions for their children, such as whether~     and when to commence artificial nutrition or ventilation. They may also have the opportunity~     to consider the care that may be appropriate for their child in the future. Despite the~     important decisions families and professionals are required to make, there is little~     empirical evidence regarding the process of decision making and future planning for this~     population. Few studies have investigated the perspectives of multiple stakeholders and none~     have addressed multiple perspectives longitudinally. Therefore the relational and contextual~     aspects of decision making and future planning for children with LLI have as yet not been~     identified.~      A multiple embedded case study utilising ethnographic methods (semi-structured interviews,~     observation and notes review) is proposed to address this knowledge gap. Families of children~     with LLI cared for in either of two participating hospitals will be recruited and followed up~     for up to 12 months. The family will be invited to nominate 'significant others' (e.g.~     relatives, friends, health care professionals) who assist them in decision making and future~     planning, to participate in the study. Outpatient clinic appointments or ward rounds during~     periods of hospitalisation will be observed and semi-structured interviews will be conducted~     approximately three times with each participant. Medical notes will be reviewed at the end of~     the study.~      This research will enable a better understanding of the experiences and preferences for~     engaging in decision making and future planning from the perspectives of all stakeholders. It~     will also provide an awareness of the communication practices involved in discussions and the~     networks of care surrounding children with LLI, including specific support needs in relation~     to their role.~   "
75435|NCT02579564|"~     The purpose of this multi-center clinical trial is to verify more effective on local control~     of malignant pleural effusions in NSCLC patients by thoracic cavity perfusion of recombinant~     human adenovirus type 5 injection and recombinant human Endostatin injection (Endostar)~     compared with cisplatin perfusion, with acceptable side effects.~   "
75436|NCT02579551|"~     This clinical trial studies the effectiveness of narrow margins in patients with low-risk~     basal cell carcinoma undergoing surgery to remove skin lesions on the face. A margin is the~     area of normal tissue around a tumor taken out during surgery to make sure all of the cancer~     is removed. This clinical trial studies tissue samples to determine the least amount of~     tissue that must be removed to give an acceptable cure rate. This may allow less normal~     tissue to be removed from patients and may be a less expensive surgery.~   "
75437|NCT02579538|"~     This observational study aims to determine the association between preoperative cognitive~     flexibility and the risk of developing PPSP by preoperative administration of cognitive~     tests.~   "
75438|NCT02579525|"~     Background: The recommended monitoring and target levels in septic shock (SSC Guidelines~     2012) including mean arterial pressure (MAP) target are not based on robust clinical data.~      Objective: To test, if in patients with septic shock, tissue perfusion guided (TPG) treatment~     strategy leads to a faster resolution of hypoperfusion than the macrocirculatory target~     guided standard care.~      Design: A prospective phase II two-parallel-group open-label randomized controlled trial~      Interventions:~        1. Intervention group- Targeted tissue perfusion guided (TTP) - care.~        2. Control group - Macrocirculatory - guided (MCG) care.~      Randomization: 1:1 stratified according to the site and presence or absence of known~     hypertension.~      Trial size: 200 randomised patients in 4 ICUs.~   "
75605|NCT02577328|"~     The assessment of pain management in Internal medicine department.~   "
75440|NCT02579499|"~     To compare clinical safety & efficacy of fixed-high potent statin therapy (according to 2013~     ACC/AHA guideline) vs. targeted LDL-C goal statin therapy (LDL<70mg/dL) for secondary~     prevention. Total 4400 patients with coronary artery disease patients requiring statin~     treatment were categorized fixed high-potent statin group and targeted LDL-C group. The~     investigators will compare primary endpoint (major adverse cardiac and cerebrovascular event~     (MACCE)) and secondary endpoint (1. New onset diabetes mellitus after randomization, 2.~     Hospitalization due to heart failure, 3. Deep vein thrombosis or Pulmonary thromboembolism,~     4. Percutaneous trans-luminal angioplasty on peripheral artery obstructive disease, 5. Aortic~     intervention or operation, 6. ESRD with renal replacement therapy).~   "
75441|NCT02579473|"~     SER-214 is a poly (2-ethyl-2oxazoline)(POZ) polymer conjugate of rotigotine, a potent~     dopamine agonist that has high affinity for the subclass of dopamine receptors in the brain~     that mediate dopamine signaling. SER-214 will be administered subcutaneously once a week via~     a standard 1 mL insulin syringe to determine the safety, tolerability and pharmacokinetic~     (PK) profile of released rotigotine and POZ-conjugate. Subjects in this study are eligible if~     they have early, stable or untreated Parkinson's disease and are still experiencing motor~     fluctuations.~   "
75442|NCT02579460|"~     The purpose of this study is to elucidate mechanisms whereby oxidative stress induced by~     acute reflux esophagitis: 1) activates p38 to regulate proteins that control the G1/S cell~     cycle checkpoint, and 2) activates HIFs (hypoxia inducible factors) to cause autocrine VEGF~     (vascular endothelial growth factor) signaling that triggers the EMT~     (epithelial-mesenchymal-transition) program in Barrett's esophagus.~   "
75443|NCT02579434|"~     The study objective is to evaluate and validate of endogenous markers for the assessment of~     CYP3A activity in Korean healthy subjects using metabolomics.~      In part 1, total 75 healthy subjects (males and females) will be enrolled. In part 2, total~     25 healthy female subject aged 20-45 years will be enrolled. In both part A and B, subjects~     will be administered midazolam I.V. 1 mg.~   "
75444|NCT02579421|"~     The purpose of this study is to examine the role of progesterone (a naturally occurring~     hormone found in both men and women) on reducing marijuana use. The investigators will see if~     progesterone effects impulsivity, withdrawal, mood and stress during marijuana cessation.~   "
75445|NCT02579408|"~     Non-alcoholic fatty liver disease is the most common chronic liver disease in Hong Kong. Its~     presence among donors of living donor liver transplants could affect the outcomes of~     recipients of liver transplantation. By using controlled attenuation parameter (CAP)~     measurements, the investigators aim to investigate the association of CAP measurements and~     severity of fatty liver among liver donors in the recipient outcomes of living donor liver~     transplantation.~   "
75446|NCT02579395|"~     In a 6-week experimental design, up to 90 adult couples in which one partner has Type 2~     Diabetes (T2D) will be randomly assigned to either the collaborative implementation~     intentions (Collaborative IIs), the Individual Implementation Intentions (Individual IIs)~     condition, or the control condition. As this is a pilot study, randomization for the~     experimental groups vs the control groups will occur at a 2:1 ratio. Thus, the experimental~     conditions will contain up to 36 participants and the control condition will contain up to 18~     participants. Adults with T2D who are living with a romantic partner, not meeting current~     physical activity guidelines but able and willing to begin a new physical activity (PA)~     routine and their partners will be assessed at baseline, 3 weeks and 6 weeks after the~     experimental manipulation. Partners will report on their own investment in the patient's goal~     and patients will report on their own PA self-efficacy. Patient's PA will be measured through~     self-report, partner report and accelerometers for a week prior to each survey assessment.~     These specific aims are planned:~      AIM 1: Determine whether collaborative IIs for patient's PA lead to a greater increase in~     partner investment in partners of adults with T2D than do individual IIs or control.~      AIM 2: Determine whether collaborative IIs for patient's PA lead to a greater increase in~     patient PA self-efficacy in adults with T2D than do individual IIs or control.~      AIM 3: Determine whether collaborative IIs for patient's PA lead to a greater increase in~     patient PA in adults with T2D than do individual IIs or control.~   "
75447|NCT02579382|"~     The primary objectives of this study are to evaluate the safety, tolerability, and efficacy~     of vesatolimod (formerly GS-9620) in adults with chronic hepatitis B (CHB) infection who are~     currently not being treated.~   "
75448|NCT02579369|"~     This is a phase I/II open-label study to evaluate the efficacy and safety of ALLO-ASC-DFU in~     patients with Dystrophic Epidermolysis Bullosa.~   "
75449|NCT02579356|"~     The study design was composed of 2 parts, 2-way crossover and multiple-dose. There are having~     2 groups in each part that have divided period 1 and period 2, and wash-out period is 16 days~     between periods. Each group is taking Telmisartan (80mg) and/or Atorvastatin (80mg) once a~     day for 6 days.~   "
75450|NCT02579343|"~     This will be a randomized, single blind study of 6 weeks duration involving the use of~     auricular acupuncture or sham acupuncture in the adjunctive treatment of depression in~     college students.~   "
75451|NCT02579330|"~     In various transanal and anal procedures it is desirable to clean the operating field from~     stool contamination. Thus mechanical bowel preparation is not well tolerated by patients.~     Enema does not provide sufficient effect. By the use of Coloshield a rectal washout might be~     performed and enable a clean operating field. In this randomized controlled trial the~     macroscopic contamination of the rectum with and without Coloshield is compared using the~     Boston Bowel Preparation Score (0-3).~   "
75466|NCT02579135|"~     This study evaluates an educational web-based intervention designed to increase adolescent~     girls' motivation and skills to engage in safer sexual behavior (Project HEART: Health~     Education and Relationship Training). Half of participants will receive Project HEART and~     half of participants will receive Project Growing Minds, an attention-matched control website~     focused on growth mindsets of intelligence and self-regulation. The ultimate goal of this~     work is to help girls reduce their risk of HIV and other sexually transmitted diseases and to~     avoid unplanned pregnancies.~   "
75606|NCT02577315|"~     Bioequivalence of two 12.5 mg empagliflozin/500 mg metformin fixed dose combination tablets~     compared to the free combination of empagliflozin 25 mg and metformin 1000 mg in healthy male~     and female volunteers under fed conditions~   "
76145|NCT02570295|"~     The purpose of this study is to determine whether the new sport concept of the Swiss Armed~     Forces influences the physical and psychological fitness of the recruits.~   "
75452|NCT02579317|"~     Despite conscious intentions to remain abstinent, persons with substance use disorders often~     find that negative emotions and environmental cues automatically trigger drinking and other~     substance use. This study aims to test whether activating the baroreflex mechanism can be~     used in the moment to help resist drinking triggers. It consists of 3 phases (Recruitment,~     Intervention, Follow-up).~      Stage 1: Trained research staff conduct a comprehensive clinical interview and questionnaires~     to assess participant's mood, substance use, and triggers. Participants are paired with a~     Primary Research Clinician (PRC) who will work with them during the intervention.~      Stage 2: Approximately 4 weeks after intake into the Center for Great Expectations Intensive~     Outpatient program, an 8-week intervention begins. Pre-and post-intervention laboratory~     sessions occur at Cardiac Neuroscience Laboratory, Center of Alcohol Studies, Piscataway, NJ.~     Some participants take part in pre- and post-intervention neuroimaging sessions (Rutgers~     University Brain Imaging Center, Newark, NJ). Participants are randomized into an active~     intervention or control group after the pre-intervention lab session. They are given an~     iPhone and trained to use a paced breathing app that is pre-loaded onto the phone.~     Participants in both groups use their app any time they anticipate or experience a trigger to~     drink or use drugs. Participants are compensated for their use of the app and the time for~     participation. To ensure that participants are correctly performing the paced breathing task,~     their PRC visit with them weekly to provide coaching sessions using a computer-based~     biofeedback program. During the 4th week, ECG and respiration data are collected.~     Participants also complete questionnaires about mood and triggers, and provide feedback on~     the usefulness of the app.~      During the lab sessions, participants complete a series of questionnaires and ECG, blood~     pressure and respiration are collected during four 5-minute tasks (resting baseline,~     non-resonance breathing, resonance breathing, and visual processing/attention). During the~     neuroimaging sessions, participants are placed in the scanner for structural scans and four~     5-minute tasks (as tasks as previously noted); ECG and blood pressure are recorded.~      Stage 3: Participants are re-contacted 1 and 3 months after the intervention to complete~     questionnaires about their quality of life across multiple domains and the usefulness of the~     app.~   "
75453|NCT02579304|"~     Evaluating the diagnostic value of transbronchial lung cryobiopsy (TBLC) as well as its~     procedural feasibility and safety in a prospective series of 20 patients with diffuse~     interstitial lung diseases (DILD) who are referred for invasive histopathological diagnostics~   "
75454|NCT02579291|"~     Individuals who had experience a stroke usually suffer from spasticity at medium and~     long-terms. The presence of spasticity in the lower extremity implies several impairments for~     standing and walking inducing high disability. A recent study has proposed the use of dry~     needling for improving spasticity in the lower extremity. No study has investigated the~     effects of deep dry needling inserted into spastic musculature in stabilometry and moto~     function in patients who had experience a stroke. A randomized controlled trial investigating~     the effects of the inclusion of deep dry needling into a Bobath interventional program on~     spasticity, motor function and balance (stabilometry) in individuals who had experience a~     stroke~   "
75455|NCT02579278|"~     In almost one third of patients with rectal cancer, cancer spreads through the bowel wall~     into nearby veins which can be seen on MRI scans and is known as mrEMVI. It has been observed~     that this is linked with worse survival due to the spread of cancer to the liver and other~     organs. The investigators think that this may occur by spread of cancer cells in the blood~     stream. Circulating cell-free tumour DNA (ctDNA) can be detected in the blood of patients~     with both metastatic and primary carcinoma (but not healthy individuals).~      This trial does not interfere with the patient's routine treatment pathway. Participants will~     be chosen if they demonstrate mrEMVI on their baseline MRI scan. 20 patients who become~     mrEMVI positive (following pre-operative therapy) and 20 patients who are mrEMVI negative~     will have blood samples taken before and during surgery and a comparison will be made between~     the two groups. If the investigators can find a link between the cancer cells seen in blood~     to mrEMVI they may be able to use this test to help guide treatment in the future. This study~     will serve as the feasibility of a larger, comparative study.~   "
75456|NCT02579265|"~     To show the superiority in safety of Smoflipid over Intralipid® as measured by the number of~     study patients in each treatment group with conjugated bilirubin exceeding 2 mg/dL during the~     first 28 days of study treatment, confirmed by a second sample collected 7 days after the~     first sample.~   "
75457|NCT02579252|"~     This study evaluates the safety and efficacy of AADvac1 in the treatment of patients with~     mild Alzheimer's disease.~      60% of participants will receive AADvac1 and 40% of participants will receive placebo.~   "
75458|NCT02579239|"~     The purpose of this study is to assess the safety and biological activity of ATYR1940 in~     patients with Limb Girdle (LGMD2B) or Facioscapulohumeral Muscular Dystrophy (FSHD).~   "
75459|NCT02579226|"~     This Phase I study is primarily designed to evaluate the safety and tolerability of AZD2811~     at increasing doses in patients with advanced solid tumours and for whom no standard of care~     exists. The study will be conducted in two parts, a dose-escalation phase (Part A) and a dose~     expansion phase (Part B). During Part A, the dose-escalation phase, patient enrolment will~     proceed according to a 3+3 design where the maximum tolerated dose (MTD) or the recommended~     Phase II dose (RP2D) could be identified. The study will also characterize the~     pharmacokinetic (PK) profile of AZD2811 and will explore the potential biological activity by~     assessing anti-tumour activity in patients. Part B will further explore PK parameters,~     safety, tolerability, and preliminary anti-tumour activity of the AZD2811 RP2D as monotherapy~     (Group 1) in patients with relapsed/refractory SCLC.~   "
75460|NCT02579213|"~     electronic nose- the tiny sensors, will smell and detect the changes in the sample of~     abnormal fetal karyotype, and fluid that will be confirmed by amniocentesis.~   "
75461|NCT02579200|"~     The purpose of this study is to determine whether inspiratory muscle training is effective to~     improve breathless and exercise intolerance in symptomatic patients with chronic obstructive~     pulmonary disease (COPD) plus chronic heart failure (HF).~   "
75462|NCT02579187|"~     To evaluate the efficacy of locally delivering plasmid DNAs encoding microRNAs, and/or~     microRNA inhibitors, in the promotion of osteogenesis and modulation of the inflammatory~     response on the basis of different clinical, radiographic, histologic and biomolecular~     outcomes in post-extraction socket defects in humans.~   "
75463|NCT02579174|"~     1. To determine whether the low-dose, biplanar x-ray imaging (EOS) has the same accuracy as~          computed axial tomography (CT)~        2. To validate low-dose, biplanar x-ray imaging (EOS) as a tool to evaluate 3-dimensional~          alignment of Total Knee Replacement implants.~        3. To evaluate differences in total knee replacement implant alignment in patients whose~          arthroplasty is performed using manual or custom instrumentation derived from~          preoperative CT~   "
75464|NCT02579161|"~     The Investigators objective is to compare the clinical efficacy of a single-day protocol with~     a short-course protocol for PCNL. The investigator hope is to reduce the use of possibly~     unnecessary prolonged antibiotic use, reduce hospital costs and prevent the further~     propagation of resistant microbes.~   "
75467|NCT02579122|"~     In view of the fact that little is known about the pre- and post-interventional coagulation~     management of phenprocoumon patients with reviparin at general practices in Germany, an~     observational study is being initiated to evaluate the effectiveness and tolerability of~     reviparin in the area of outpatient, general practice-based care in the context of bridging~     therapy. Patients for whom bridging therapy with low-molecular weight heparin (LMWH) was~     specified and for whom the LMWH reviparin was chosen for this purpose shall be investigated.~   "
75468|NCT02579109|"~     Introduction:~      Autism spectrum disorder is characterized by deficits in three functional domains: language~     and communication, social reciprocity, and the presence of restricted interests/repetitive~     behaviors. There's also deficits in social cognition. When having a face-to-face~     conversation, a listener not only hears what a speaker is saying, but also sees the~     articulatory gestures that accompany those sounds. Speech signals needs then a multisensory~     processing. Impairments in multisensory perceptual binding may be particularly relevant in~     ASD, given that hallmark features of the disorder include difficulties in speech,~     communication, and social interactions.~      Objectives:~      The investigator suggest that atypical multisensory processing in ASD may have an impact on~     speech perception and social processing.~      Aims:~      Methods:~      This pilot study measures free recall scores in 3 lists of words presentation after 30~     minutes. In the first condition (CI) words are only listening. In the second condition (CII)~     words are associated with a picture of a mans face. In the third condition (CIII) words are~     associated with a video of a man speaking. Three lists are homogeneous form words~     characteristics (lexical frequency, emotional valence norm, imageability). Participants were~     7- to 13-year-olds typically developing children (TD) (N = 19) and ASD children (N = 19).~      The investigator would create some new tools for exploring the treatment of a social~     information. These tools should be the closest of a ecological social interaction.~   "
75469|NCT02579096|"~     This trial will compare two effective therapies, allopurinol and febuxostat, to lower serum~     uric acid and therefore prevent further gout attacks. These therapies have never been~     compared at appropriate doses. Further, they will be studied in patients with kidney disease~     for the first time.~   "
75470|NCT02579083|"~     The purpose of this study is to assess the safety and pharmacokinetics of MB66, a monoclonal~     antibody film for vaginal application that is being developed to potentially reduce the~     transmission of herpes simplex virus (HSV) and human immunodeficiency virus (HIV).~   "
75471|NCT02579070|"~     The purpose of this study is to investigate whether regular measurement of skin foot~     temperature with a novel device (DFUPS) will prevent ulcer recurrence in diabetic patients at~     high risk of foot ulceration. It is planned to regularly measure the temperature of the feet~     of people with diabetes who have already had a foot ulcer which has subsequently healed.~     These measurements should allow the identification of hotspots on the foot and may be helpful~     when advising about ulcer risk and providing preventative treatment. It is hoped to find out~     whether the regular use of thermal images taken with the DFUPS device together with standard~     foot treatment may reduce the number of people with diabetes developing ulcers or even~     prevent foot ulcers.~   "
75472|NCT02579057|"~     This study evaluates the clinical efficacy of subcutaneously administered Furosemide~     Injection Solution versus intravenous administration of Furosemide Injection, United States~     Pharmacopeia (USP) in adult patients presenting to a heart failure clinic with decompensated~     heart failure. Half of the patients will receive a subcutaneously administered Furosemide~     Injection Solution; the other half will receive an intravenous administration of Furosemide~     Injection.~   "
75473|NCT02579044|"~     This is a phase I/II dose-escalation trial of everolimus in combination with lonafarnib in~     Hutchinson-Gilford Progeria Syndrome (HGPS) and progeroid laminopathies (henceforth~     progeria). The study will be conducted at a single clinical site utilizing the Clinical and~     Translational Study Unit (CTSU) at Boston Children's Hospital. Lonafarnib will be~     administered at doses previously established in the pediatric population and in this~     population of progeria subjects. This study will first determine the dose-limiting toxicities~     (DLT) and the maximum tolerated dose (MTD) of everolimus when administered in combination~     with lonafarnib. It will then determine the efficacy of everolimus when administered at its~     MTD in combination with lonafarnib for disease in progeria.~   "
75474|NCT02579031|"~     PCI is considered as the reperfusion strategy of choice for patients with acute STEMI. Data~     from RCTs and meta-analyses demonstrate a consistent and strong signal towards a significant~     reduction in MACE among patients with STEMI undergoing primary PCI with newer generation~     stents with enhanced biocompatibility.~      The present trial aims at filling the current gap of evidence by providing randomized data to~     establish the superior clinical outcome with an ultrathin strut third-generation DES with~     biodegradable polymer designed to improve vascular healing in patients with STEMI undergoing~     primary PCI, compared to the current state-of-the art second-generation DES with permanent~     polymer.~   "
75475|NCT02579018|"~     There are two major goals of this investigation. First, to develop pilot data to justify a~     larger randomized clinical trial of an intervention designed to train interoceptive signals~     (IS) and interoceptive responsivity (IR) in persons with Anorexia Nervosa (AN). Second, the~     investigators will determine whether persons with AN have similar or different IS and IR for~     heart rate while exercising as compared to age and gender matched controls.~   "
75476|NCT02579005|"~     This project will assess the feasibility of treating advanced cancer using the immune system,~     without any anti-cancer drug. In this pilot study, the investigators propose combining~     low-dose radiotherapy, in lung cancer patients, with allogeneic immune cells obtained from a~     donor. The patients will receive radiotherapy directed to one of the patient's tumors, as~     well as an immunomodulatory drug called cyclophosphamide. Thereafter, they will receive the~     infusion of donor immune cells.~   "
75477|NCT02578992|"~     The purpose of this study is to investigate two different patient's head and neck~     positions(neutral head position and head-lift position) for the effectiveness of orotracheal~     intubation with using the Clarus Video System (Trachway®) intubating stylet.~   "
75528|NCT02578329|"~     The purpose of this study is to determine whether a Mediterranean Diet, personalized in terms~     of total calories, total lipids and balanced in terms of saturated, mono- and~     poly-unsaturated lipids, corrects the adverse fatty acid profile of patients with CHD and~     reduces markers of oxidative stress and inflammation more effectively than a low-fat dietary~     advice.~   "
75478|NCT02578979|"~     Paroxysmal atrial fibrillation is often undetected because characteristics such as short~     duration, episodic, and frequently asymptomatic nature make it challenging to diagnose at the~     bedside, leading to suboptimal secondary prevention. It is not uncommon for paroxysmal atrial~     fibrillation to be undetected in a single electrocardiogram (ECG) on admission. Conventional~     24-hour Holter monitoring is often used to detect paroxysmal atrial fibrillation. However,~     systematic review suggests Holter monitoring will identify atrial fibrillation in only an~     additional 4.6% of patients, no better than detection rates observed in groups lacking~     routine monitoring. On the other hand, for ischemic stroke patients with sinus rhythm at~     baseline but paroxysmal atrial fibrillation still suspected, no recommendation beyond~     repeated 12-lead ECGs is made in the United Kingdom guideline. Serial 12-lead ECG has been~     used to detect possible paroxysmal atrial fibrillation among acute ischemic stroke patients~     and found 15 new cases of atrial fibrillation in 133 acute ischemic stroke patients (11.3%)~     without atrial fibrillation at baseline. The optimal investigation strategy, including~     modality, duration of investigation, and patient subgroup remains undefined, not only for~     efficacy in the detection of atrial fibrillation, but also cost-effectiveness in healthcare~     systems. The objective of this project is to conduct a pragmatic multicenter randomized~     controlled trial for the comparison of serial 12-lead ECG once daily for 5 days and 24-hour~     Holter to detect paroxysmal atrial fibrillation in acute ischemic stroke patients without~     atrial fibrillation identified by baseline ECG or history.~   "
75479|NCT02578966|"~     The purpose of this study is to compare the effectiveness of a traditional oral health~     educational program and a program based on the theories of the Motivational Interview~     directed to the child's mothers/fathers/responsible parents to reduce childhood caries (2 and~     3 years of age).~   "
75480|NCT02578953|"~     This will be a single center, open-label, single dose, randomized and 2-way crossover study~     in healthy Japanese male subjects under fasting conditions. The study will be conducted to~     determine the bioequivalence between dutasteride capsules manufactured at GSK (test product)~     and dutasteride capsule manufactured at Catalent (reference product) in healthy Japanese male~     subjects. Subjects will have a screening visit within 30 days prior to the first dose of~     study treatment, two treatment periods separated by 28-days washout period, a re-visit 10-14~     days after the second dose for the first follow-up and a second follow up via telephone 50-54~     days after the second dose. The total duration of the study will be approximately 15 weeks~     from screening to the second follow up.~   "
75481|NCT02578940|"~     The main aim is to assess the impact of using fluciclovine (18F) (as a PET imaging~     radiotracer) on the clinical and treatment decision required for managing patients with~     biochemically recurrent prostate cancer (BCR) who are being considered for salvage treatment~     with the intention of providing disease cure. Also, this study will consolidate the~     information regarding diagnostic performance of fluciclovine PET/CT in a large number of~     prospectively followed patients at several centres in the UK and assess the effect of PSA~     level on the likelihood of detecting cancer lesions by fluciclovine (18F).~   "
75482|NCT02578927|"~     The objective is to investigate whether the ingestion of green tea prior to physical exercise~     improvement post-exercise hypotension (PEH). Double-blind, randomized, placebo study. Fifteen~     hypertensive (53±4.5 years) performed three procedures: green tea+exercise (GT+Ex),~     placebo+exercise (PL+Ex), green tea without exercise (GT). Thirty minutes after ingesting 2g~     of green tea or placebo, they performed treadmill walking (60 minutes), 60 to 85% of maximum~     heart rate intensity in procedures with exercises. BP was measured at rest and at every 10~     minutes after exercise (60 minutes). Blood samples were taken before the ingestion of green~     tea or placebo and immediately after exercise to determine Malondialdehyde (MDA) and Nitrite~     (NO) dosages. Reduction of systolic BP compared with the rest, during PL+Ex recovery~     procedure.~   "
75483|NCT02578914|"~     This is a randomized, parallel, single center, double masked, vehicle controlled study. The~     purpose of this study is to determine the activity and safety of NS2 in patients with grass,~     tree or ragweed-pollen induced seasonal allergic conjunctivitis . Subjects will be randomized~     1:1 to receive multiple doses of NS2 Ophthalmic Drops (0.5%) or NS2 Ophthalmic Drops Vehicle~     (0.0%).~      Free aldehydes are thought to be related to inflammatory conditions such as allergic~     conjunctivitis. NS2, a small molecule aldehyde trap, is being evaluated to determine whether~     it may decrease inflammation by lowering aldehyde levels.~   "
75484|NCT02578901|"~     The purpose of this study is to evaluate the usefulness of antifibrinolytic therapy with~     tranexamic acid (TXA) in preventing bleeding in patients who are thrombocytopenic due to~     primary bone marrow disorders or chemotherapy, immunotherapy and/or radiation therapy.~   "
75485|NCT02578888|"~     This randomized clinical trial studies a palliative care program in improving the quality of~     life of patients with high-risk gynecologic malignancies that is original or first tumor in~     the body (primary) or has come back (recurrent). Palliative care is care given to patients~     and their families facing the problems associated with life-threatening illness, through the~     prevention and relief of suffering by means of early identification and impeccable assessment~     and treatment of pain and other problems, physical, psychosocial and spiritual. Studying a~     palliative care program may help doctors learn more about patients quality of life, use of~     healthcare services, and the relief of pain.~   "
75486|NCT02578875|"~     Background:~      Researchers are testing a new way to find out what causes infections in people in hospitals.~      Current techniques use chemical or biological tests on a person s samples. Samples are blood,~     tissue, stool, saliva, urine, etc. Researchers are testing new techniques that use a device~     called MiSeq. It can sequence all of the DNA (genetic material) in a sample. This may show~     microorganisms, such as bacteria, fungi, and viruses that cause infection. Researchers want~     to know if the new test works as well or better than current tests. They will do this by~     looking at about 250 samples.~      Objective:~      To test if MiSeq works as well as or better than current tests to identify microorganisms~     that cause infection.~      Eligibility:~      NIH patients whose samples have been sent to the Microbiology Service s lab for routine~     microbiologic testing.~      Design:~      Participants will consent to have samples they gave as part of their routine medical care~     used in the study. For those under age 18, a parent or legal guardian will consent.~   "
75529|NCT02578316|"~     The purpose of this study was to determine the metabolism and elimination of 14C-lenvatinib~     in participants with advanced solid tumors or lymphomas, who were unsuitable for, or had~     failed, existing therapies.~   "
75487|NCT02578862|"~     Utilization of total intravenous anesthesia (TIVA) has been proposed as a method to improve~     visualization during endoscopic sinus surgery (ESS), largely due to its physiologic decrease~     in cardiac output without the peripheral smooth muscle relaxation and resultant vasodilation~     associated with inhaled anesthetics. This may be especially important in cases of advanced~     inflammatory sinus disease, when visualization may be most compromised. The goal of this~     study is to improve clinical practice paradigms by evaluating the use of TIVA versus inhaled~     anesthetic for maintenance of anesthesia in ESS for advanced paranasal sinus disease.~   "
75488|NCT02578849|"~     The aims of this proposal include tests of hypotheses of the pathogenetic mechanisms of~     noradrenergic neurotransmission in Parkinson's disease in vivo, using positron emission~     tomography of patients with early and advanced Parkinson's disease with or without 3,4~     L-dihydroxyphenylalanine (L-DOPA) - induced dyskinesia or co-morbid depression, and~     evaluation of whether these mechanisms can be influenced therapeutically.~      Hypotheses:~        1. The investigators argue that release in human cortical and subcortical brain regions of~          norepinephrine (NE) derived from metabolism of exogenousL-DOPA is greater in Parkinson's~          disease patients with L-DOPA- induced dyskinesia than in patients without this~          complication. This hypothesis will be tested by measuring antagonist [11C]yohimbine~          binding to alpha-2 adrenoceptors before and after L-DOPA challenge.~        2. If so, it is argued that the greater rise of norepinephrine, measured as [11C]yohimbine~          displacement after L-DOPA challenge, is the result of down-regulation or loss of~          norepinephrine transporters. This hypothesis will be tested by measuring the binding of~          [11C]MeNER, a tracer of norepinephrine transporters.~        3. If so, the investigators argue that the greater decline of [11C]MeNER binding is~          significantly correlated to the symptoms of Parkinson's disease, as proof that patients~          with more severe loss of noradrenergic terminals exhibit more severe motor deficits.~   "
75489|NCT02578836|"~     This study assesses weight loss from the Endoscopic Vertical Gastroplasty or Fogel~     Gastroplasty (FG). The purpose of the study is to:~        -  Document that weight loss occurs (12 months)~        -  Determine if it alters general wellbeing (emotionally and physically)~   "
75490|NCT02578823|"~     The purpose of this study is to determine whether targeted temperature management at~     36.0˚C(TTM-36) in patients who remain unconscious after resuscitation from in-hospital~     cardiac arrest(IHCA) will reduce death and disability compared with fever control. For this~     purpose, the current pilot study will be undertaken to establish the feasibility, safety, and~     surrogate outcomes of hypoxic-ischemic brain injury in 60 patients who remain unconscious~     after resuscitation from IHCA.~      Eligible patients will be randomly assigned in a 2:1 ratio to either TTM-36(n=40) or~     conventional treatment group(n=20). Randomization will be performed with stratification~     according to initial rhythm (shockable vs. non-shockable).~   "
75491|NCT02578810|"~     Pre-eclampsia, more than being proteinuric gestational hypertension alone, is a state of~     exaggerated systemic inflammation and remains a leading direct cause of maternal morbidity~     and mortality worldwide.1 Standardization of antenatal and postnatal assessment and~     surveillance of pre-eclampsia with protocols that recognize the systemic inflammatory model~     of preeclampsia have been associated with reduced maternal morbidity.~   "
75492|NCT02578797|"~     The purpose of this study is to determine whether daily treatment with apalutamide affects~     the ventricular repolarization in participants with Castration-Resistant Prostate Cancer~     (CRPC)~   "
75493|NCT02578784|"~     The incidence of hemodynamically relevant dialysis fistula stenoses/obstructions after 1 year~     is between 60-90% (from 62.5 to 91% radiocephalic, brachiocephalic 70-84%, PTFE shunts~     62-87%), necessitating a therapeutic measure to preserve dialysis access during this period~     in 1/3 of the patients. This therapeutic measure is a dilatation of the stenosis using a~     standard PTA balloon (POBA, plain old balloon angioplasty with a primary technical success~     rate of 50-79% [2-4].In turn, in 21-50% of the cases an insufficient PTA result is obtained~     (so-called POBA-resistant stenosis). In these cases, predilatation with a so-called cutting~     balloon (carrying with small knives on its surface) is performed, leading to a success rate~     of 89%. However, a problem is the high incidence of restenosis, which is about 40% for~     recurrent stenosis and over 10% in de novo stenosis.~      The use of drug-coated balloon (DCB) in non-POBA resistant stenoses lead to a reduction in~     the restenosis rate of 35% to 5%. However, the effect of DCB in POBA resistant stenoses is~     unknown.~      Therefore, the aim of this study is to evaluate the clinical benefit of the combined use of a~     cutting balloon and a drug-coated balloon in POBA resistant dialysis fistula stenoses~     compared to the sole use of a cutting balloon.~   "
75494|NCT02578771|"~     ZuraPrep is being evaluated for efficacy as a preoperative skin preparation solution to~     demonstrate its immediate and persistent antimicrobial properties. At least 72 subjects will~     be randomized utilizing bilateral applications on abdomen and groin. ZuraPrep active product~     and reference positive control will be compared; ZuraPrep non-active and negative control~     will be compared. Each subject will receive two of the planned treatments, one on the left~     side of body and one of the right. Study duration for subjects - 3 to 4 weeks.~   "
75495|NCT02578758|"~     The aim of this study is to assess the efficacy of a Transdiagnostic Internet-based Protocol~     (Emotion Regulation Protocol) for the treatment of Emotional Disorders (ED) (major depression~     disorder, dysthymic disorder, obsessive-compulsive disorder and four anxiety disorders: panic~     disorder, agoraphobia, generalized anxiety disorder, and social anxiety disorder) both in~     terms of efficacy regarding depressive and anxiety symptomatology and its potential impact on~     higher-order psychological dimensions (neuroticism/behavioral inhibition and low positive~     affect/behavioral activation) in a community sample. It will also be tested the differential~     effect of a specific treatment component based on positive psychology techniques in positive~     affect. The main hypotheses are: 1) both modalities of the protocol (TP and TP+PA) will be~     more effective than the WL condition in the primary outcome measures. Investigators also~     expect scores on positive affect to be higher in the TP+PA condition than in the TP~     condition.~   "
75607|NCT02577302|"~     As a screening evaluation, all subjects will have a needle placed transcutaneously at the~     baseline visit to confirm that the subject feels a pulsation on the foot or toes with or~     without flexion of one or more of the toes. This motor nerve test demonstrates that the nerve~     is responsive to stimulation as an indicator that the subject is an eligible candidate for~     both PTNS and CAN-Stim therapies.~      Subjects will be randomized to either CAN-Stim or PTNS after eligibility is determined from~     the screening test.~   "
75496|NCT02578745|"~     Surgical site infections (SSIs) complicate 5 - 12% of cesareans. Negative pressure wound~     therapy (NPWT) - a closed, sealed system that applies negative pressure to the wound surface~     - has been used to treat open wounds since the late 1990s. Experimental evidence suggests~     NPWT promotes wound healing by removing exudate, approximating the wound edges, and reducing~     bacterial contamination. Although effectiveness of prophylactic NPWT is biologically~     plausible and non-randomized studies suggest benefit in reducing SSIs, good quality data is~     lacking. The objective of this pilot randomized controlled trial of 120 patients to test the~     hypothesis that prophylactic NPWT will reduce SSIs and other wound complications after~     cesarean in obese women. The investigators will randomly assign obese women undergoing~     cesarean delivery to Standard dressing or prophylactic NPWT with the PICO system after skin~     closure. The primary outcome will be a composite of superficial or deep SSIs per Centers for~     Disease Control and Prevention (CDC) criteria and other wound complications (separation,~     hematoma, seroma) after cesarean.~      Secondary outcomes will include wound dehiscence (≥2 cm); hematoma; seroma; composite of~     wound complications; patient pain and satisfaction scores; physician office visit or~     emergency department (ED) visits for SSIs; and hospital readmission for wound complications.~   "
75497|NCT02578732|"~     Preliminary data suggests that FOLFOX-A may have equal or superior activity as compared to~     FOLFIRINOX for patients with metastatic pancreatic cancer and appears to be better tolerated~     with the ability to administer at least 10 cycles of therapy. Investigators therefore will~     evaluate FOLFOX-A in a phase II study for patient with locally advanced pancreatic cancer.~   "
75498|NCT02578719|"~     This study evaluates effectiveness of greater occipital nerve blocks with bupivacaine~     compared to placebo in chronic migraine patients.~   "
75499|NCT02578706|"~     Advances in antiretroviral therapy (ART) have resulted in increased survival of the~     HIV-infected population; however, this gain in longevity is associated with an increased risk~     of cardiovascular disease (CVD). Although ART and traditional risk factors contribute to CVD~     in this population, heightened markers of immune activation, inflammation, and coagulation~     independently predict morbidity and mortality, suggesting that dysregulation of these systems~     plays a significant role in the increased risk of CVD. The investigators believe that~     platelet activation is an important driver in HIV-associated immune activation, inflammation,~     and coagulation, leading to an increased CVD pathophysiology and risk. Platelets initiate~     thrombus formation and also play a key role in vascular inflammation by releasing~     pro-inflammatory mediators and cross-talking with other relevant cell types including~     leukocytes. Researchers have described platelet hyperreactivity in chronic HIV infection.~     Importantly, the investigators demonstrated that one week of anti-platelet therapy (aspirin)~     decreased platelet activation and immune activation, with an improved trend in inflammation~     and immune parameters. The overall hypothesis is that platelet activation is a major driver~     of immune activation, inflammation, and thrombosis in ART-treated HIV infected patients. The~     purpose of the proposed proof-of-concept study is to understand the mechanism(s) by which~     anti-platelet therapy improves immune and inflammatory parameters in chronic HIV infection.~     To test this, the immune modulating and anti-inflammatory effects of 24 weeks of the~     anti-platelet drug aspirin as compared to the anti-platelet drug clopidogrel will be~     evaluated. Given their different mechanisms of action and inhibitory potency, the~     investigators can differentiate whether the potential benefits are mediated via inhibition of~     arachidonic acid (aspirin) or inhibition of ADP (clopidogrel) or by the antithrombotic~     activity. A secondary goal is to perform multidimensional assays of platelet activity and~     thrombogenicity alongside immune activation assays and careful assessments of traditional~     risk factors and medication regimens, to understand which parameters are highly associated~     with thrombogenicity.~   "
75500|NCT02578693|"~     The study is designed to provide long term clinical and virologic follow up in subjects~     infected with hepatitis C virus (HCV) who received interferon-based therapy or direct-acting~     antiviral agents (DAAs)-based therapy. This long term follow up study is observational and no~     treatment is provided for HCV infection.~   "
75501|NCT02578680|"~     This is an efficacy and safety study of pembrolizumab (MK-3475) combined with~     pemetrexed/platinum chemotherapy versus pemetrexed/platinum chemotherapy alone in~     participants with advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who~     have not previously received systemic therapy for advanced disease. Participants will be~     randomly assigned to receive pembrolizumab combined with pemetrexed/platinum (Investigators~     choice of cisplatin or carboplatin), OR pemetrexed/platinum (Investigators choice of~     cisplatin or carboplatin).~      The primary hypothesis is that pembrolizumab in combination with pemetrexed/platinum~     chemotherapy prolongs Progression-Free Survival (PFS) and Overall Survival (OS) compared to~     pemetrexed/platinum chemotherapy alone.~   "
75502|NCT02578667|"~     Prospective cohort study. All patients presenting for percutaneous abdomino-pelvic soft~     tissue ablation, biopsy, or drainage performed under the care of Dr. Issam Kably will become~     part of the study population. Based on prior imaging and/or imaging at the time of the~     procedure, patients will fall into two groups, those for whom no compression is necessary to~     complete the procedure and those for whom compression may provide benefit. These would be~     selected based on Dr. Kably's experience as a practicing academic, fellowship-trained, and~     CAQ'ed interventional radiologist. The latter group would then further subdivide into those~     who give consent for use of the compression device and those who do not consent. Results of~     each group would be measured including the following: termination versus successful~     completion of the procedure; adverse events including bleeding or damage to surrounding~     structures necessitating further medical or surgical intervention.~   "
75503|NCT02578654|"~     A quasi-experitmental study of the efficacy interventions, including additional HIV care team~     daily inpatient round and three telephone calls to remind the upcoming clinic appointment, in~     improving HIV care engagement within 30 days after hospital discharge among HIV-infected~     patients.~   "
75504|NCT02578641|"~     This study is a multi-center, randomized, open label, Phase III clinical trial for advanced~     Nasopharyngeal Carcinoma(NPC) Patients.~      Drugs used in chemotherapy, such as gemcitabine and carboplatin, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving an infusion of a person's cytotoxic T lymphocytes (CTL) that have been~     treated in the laboratory may help the body build an effective immune response to kill tumor~     cells. Giving combination chemotherapy together with laboratory-treated T lymphocytes may~     kill more tumor cells. This Phase III trial is to assess if combined gemcitabine-carboplatin~     (GC) followed by adoptive T-cell therapy would improve clinical outcome for patients with~     advanced nasopharyngeal carcinoma (NPC). It is also the world's first, and largest, Phase 3~     T-cell therapy cancer trial ever conducted, and enrollment is ongoing for 330 patients from~     29 hospital centers across Asia and the United States.~      This clinical trial is conducted on the back of a successful Phase 2 NPC trial involving 38~     patients at the National Cancer Centre, Singapore. This trial produced the best published~     2-year (62.9%), and median overall survival (OS) data (29.9 months) in 35 patients with~     advanced NPC who received autologous EBV-specific CTL. Kindly see~     https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3978790/ for the Phase 2 publication titled~     Adoptive T-cell Transfer and Chemotherapy in the First line treatment of Metastatic and/or~     Locally Recurrent Nasopharyngeal Carcinoma.~   "
75505|NCT02578628|"~     The Chronic Kidney Disease Engagement System is currently in place for 1700 adults receiving~     care from Empire Physicians Medical Group (EPMG), an Independent Practice Association located~     in Palm Desert, California. The system monitors routine clinical laboratory test results and~     send messages to patients and providers when action is indicated, such as when tests are~     overdue or results require extra clinical attention. This study will assess what happens to~     laboratory results, utilization of laboratory tests, and costs of care when ther system is~     discontinued.~   "
75506|NCT02578615|"~     The pilot study was conducted in the form of an open prospective single-arm observational~     study with 28 patients who received physiotherapy at the Spiraldynamik® Med Center in Zurich.~   "
75507|NCT02578602|"~     This pilot clinical trial studies magnetic resonance imaging (MRI) with gadoxetate disodium~     in measuring tumors in patients with liver cancer. Diagnostic procedures, such as MRI with~     gadoxetate disodium, may help find and diagnose liver cancer and find out how far the disease~     has spread. It is not yet known whether MRI with gadoxetate disodium provides a more precise~     measurement of liver tumors than standard computed tomography (CT).~   "
75508|NCT02578589|"~     The purpose of this trial is to evaluate the effect of conservative treatment in comparison~     to arthroscopic resection of pathological medial plicae of the knee for patients with medial~     plica syndrome. The investigators expect conservative treatment to be significantly superior~     to arthroscopic plica resection with regard to symptom remission and return to prior~     functional level.~   "
75509|NCT02578576|"~     Crohn's disease is a chronic inflammatory transmural bowel disorder characterized by high~     rate of postoperative anastomotic complications and recurrences. Surgery itself can influence~     immunologic function and trigger inflammatory response, which may result in the flare of~     Crohn's disease soon after surgery (within one month), especially near the anastomosis. Early~     flare-up of Crohn's disease can negatively impact the outcomes of operation. However, due to~     the the complexity of perioperative period and dangerous of invasive examine, it is difficult~     to distinguish disease flare from postoperative complications.~      In this study, the investigators aim to development a diagnostic method of flare-up within~     one month after surgery, which can help us to detect and then treat disease flare in time.~   "
75510|NCT02578563|"~     To evaluate clinical effectiveness and safety of Singaporean Type 2 Diabetes mellitus~     patients administered SGLT 2 inhibitor monotherapy or in combination with other commonly used~     hypoglycaemic drugs in real life clinical settings.~      To evaluate real life clinical effectiveness and safety of Sodium-Glucose Co-Transporter~     inhibitor- 2 in Singaporean Type 2 diabetes mellitus patients treated on an outpatient basis~     in clinical practice setting. The study would also assess treatment patterns with SGLT2~     inhibitor patient relevant outcomes in whole population as well as pre identified patient~     subgroups.~      Primary analysis to be done at 1 year and extended analysis at 2 years.~   "
75511|NCT02578550|"~     The purpose of this study is to evaluate the single-dose pharmacokinetics and pivotal~     bioequivalence of Darunavir (DRV) 800 milligram (mg), Emtricitabine (FTC) 200 mg, and~     tenofovir alafenamide (TAF) 10 mg when administered as a fixed-dose combination (FDC)~     (D/C/F/TAF) relative to the separate agents (DRV 800 mg tablet formulation and FTC/TAF 200/10~     mg FDC) in the presence of 150 mg Cobicistat (COBI), under fed conditions, in healthy~     participants.~   "
75512|NCT02578537|"~     Ticagrelor, a new P2Y12 receptor antagonist, achieve faster, consistent and higher platelet~     inhibition than clopidogrel, which was considered more noticeable in patients with ACS~     combining chronic kidney disease(CKD). Nonetheless, the pharmacokinetic properties of~     ticagrelor in the patients with CKD and NSTE-ACS has not been thoroughly studied. This study~     was designed to provide PK and PD data of ticagrelor compared with clopidogrel, in order to~     estimate that ticagrelor is superior to clopidogrel in getting better inhibition of platelet~     in patients with CKD and NSTE-ACS. P2Y12 inhibitor naïve patients with CKD (eGFR < 60~     ml/min/1.73m2 ) and NSTE-ACS will be enrolled in this single-center, prospective, randomized,~     parallel-control study and randomly assigned in a one-to-one ratio to receive ticagrelor or~     clopidogrel on top of chronic aspirin treatment. The primary endpoint was the PRU by Verify~     Now at 30 days after loading dose.~   "
75513|NCT02578524|"~     This study will examine patient satisfaction and spectacle independence using a survey in~     patients who have undergone uncomplicated cataract surgery with a presbyopia-correcting lens~     at least 2 years prior to administration of the survey.~   "
75514|NCT02578511|"~     In this phase I study, escalating doses of IXAZOMIB will be combined with the POMP/D regimen.~   "
75515|NCT02578498|"~     No studies have investigated if the dietary composition of carbohydrate influences the~     glycaemic effect of single and multiple boluses of subcutaneous low-dose glucagon. Further,~     the recommended diet composition to patients with type 1 diabetes has not been thoroughly~     validated. Many patients with type 1 diabetes practice low carbohydrate eating patterns due~     to the assumption that this diet can reduce fluctuations in plasma glucose. Before glucagon~     can be used as an add-on to intensive insulin treatment, these aspects need to be elucidated.~     The purpose of this study is to determine, whether diet composition of carbohydrate affects~     the glycogen stores in the liver and affects the glucose response of glucagon during~     hypoglycaemia.~      HYPOTHESIS: In patients with type 1 diabetes, the glucose response of a single bolus of~     low-dose glucagon is not associated with diet carbohydrate content.~      AIM: The aim is to investigate how one week of high- compared to low-carbohydrate diet~     influence the glycaemic response of low-dose glucagon in patients with insulin pump treated~     type 1 diabetes. The secondary aim is to investigate how two dietary intervention weeks~     differ in the incidence of hypoglycaemia, postprandial hyperglycaemia, and daily glucose~     excursions.~      DESIGN:A non-blinded two-way cross-over, randomized study will be conducted. After~     participants have given an informed consent, they will go through four steps: 1) screening~     visit 2) Run-in period, 3) first meal intervention for one week finalizing with one study~     visit and 4) second meal intervention for one week finalizing with another study visit.~   "
75530|NCT02578303|"~     Obstructive sleep apnea syndrome (OSAS) is a sleep-disordered breathing characterized by the~     occurrence of repeated upper airway obstructions leading to airflow reduction (hypopnea) or~     cessation (apnea). The apnea-hypopnea index (AHI) is the number of apneas and hypopneas per~     hour of sleep. OSA patients often report cognitive complaints.~      About 25% of the elderly population is affected by this syndrome with a drastic increase of~     this rate among dementia patients. OSAS is considered to be an important risk factor for the~     development of hypertension, heart disease and stroke.~   "
75516|NCT02578485|"~     Background: The active video game (VGA) it has been studied how much to the physiological~     factors of your practice. The objective was to determine whether an AVG session promotes~     post-exercise hypotension (PEH) similar to walking exercise. Methods: Fifteen hypertensive~     (49.0 ± 1.6 years), both genders performed five randomized sessions, lasting 60 minutes: 1)~     AVG, 2) sedentary video game (SVG), 3) walk treadmill with moderate intensity (WMI), 4) walk~     treadmill with similar intensity to VGA (WGI), and 5) control without exercise (CON).~     Intensity was determined by Heart rate (HR) and Perceived Exertion (PE). Blood pressure (BP)~     and cardiac autonomic modulation (CAM) measurements were taken at rest and every 10 minutes~     post exercise for 60 minutes.~   "
75517|NCT02578472|"~     The purpose of the study is to evaluate the effects of JNJ-42847922, compared to zolpidem and~     placebo, on driving performance as assessed by the mean difference of standard deviation of~     lateral position (SDLP) after forced awakening using a validated driving simulator test at 2,~     4, 6 and 8 hours post-evening dose.~   "
75518|NCT02578459|"~     The purpose of this study is to compare efficacy of pain treatment with ITDD to efficacy of~     pain treatment with CMM in patients with pancreatic cancer pain.~   "
75519|NCT02578446|"~     The optimal method of total knee replacement component fixation to the bone remains a~     challenge. The use of bone cement is considered the gold standard and is the preferred~     technique for most surgeons. However, uncemented fixation methods have been developed in an~     attempt to tackle problems that can be seen when cement is used. The cement-bone interlock~     can deform and degrade over the years and can lead to aseptic loosening, especially in young~     and active patients. A loosened prosthesis results in an impaired functioning and painful~     knee in daily life for which a revision of the prosthesis may be necessary. To prevent~     aseptic loosening and subsequent revision surgery, new methods of uncemented fixation have~     been developed.~      One of these methods is to use a highly porous metal called Tritanium®. It can improve the~     biologic fixation by resembling the characteristics of trabecular bone. It is expected that~     this surface aids bone ingrowth and to have similar or even better results concerning early~     fixation properties and long-term durability compared with cemented fixation. Excellent~     results using this highly porous Tritanium have been seen in total hip surgery already.~      This single-blinded, randomized clinical trial will assess clinical and radiological outcomes~     including Roentgen Stereophotogrammetry (RSA) measurements of a newly approved uncemented~     Triathlon Tritanium CR total knee prosthesis compared with a standard cemented Triathlon~     metal-backed CR total knee prosthesis (both by Stryker Orthopaedics). Two arms of each 35~     patients will be included.~      The primary outcome measure will be prosthetic migration after two years of the uncemented~     Triathlon Tritanium CR Total Knee and the cemented Triathlon CR Total Knee by means of RSA.~     It is hypothesized that the new uncemented Tritanium prosthesis will perform at least equally~     good in terms of migration and clinical parameters compared with the standard cemented~     Triathlon.~      The secondary outcome measure will be long-term (10-year) survival based on the two-year~     migration patterns combined with clinical factors and radiographic aspects. In order to~     identify other clinical parameters besides the fixation of the prosthesis components,~     clinical scores and radiographic aspects will be correlated with the RSA outcome. The 10-year~     results will be used to verify the predicted long-term survival results.~   "
75520|NCT02578433|"~     In recent years there has been convincing evidence of the positive effects of mindfulness~     based interventions, as a form of complementary and alternative medicine in regards to~     subjective well-being and physical health. There is growing evidence concerning the positive~     effects of these techniques in regards to an adequate stress management (e.g. respiration and~     heart rate variability). These findings can be found as well documented in the literature.~     For this study it is conducted to gain further insights into the role of mindfulness based~     meditation techniques for psychological well-being. Therefore it is intended to focus on~     clinical groups (e. g. depression and anxiety patients) in order to find out more about the~     relevance of mindfulness based meditation techniques as an adjunct for psychiatric and~     psychotherapeutic treatment. In this study special aspects of mental and spiritual health~     (e.g. self compassion, subjective perceived stress, spiritual well-being, and psychiatric~     symptoms) should be examined by comparing a group of clinical patients which practice~     mindfulness based meditation once a week with a control group, practicing PMR (progressive~     muscle relaxation)~   "
75521|NCT02578420|"~     To date, very little is known about the mechanisms of open-label placebo treatment and there~     is a lack in highly controlled experimental designs. Therefore, the planned project will test~     well-established explanatory models of (deceptive) placebo, i.e., (1) expectancy, (2) meaning~     response, in an open-label placebo design, investigating their influence on placebo~     analgesia.~   "
75522|NCT02578407|"~     This study aims to determine the treatment effect of accommodative/vergence therapy on myopic~     children by assessment of accommodative function before and after therapy.~   "
75523|NCT02578394|"~     The aim of this study is to determine the feasibility of running a phase III double-blind,~     double-dummy randomised controlled trial comparing Depo-Medrone 120mg intramuscular injection~     vs. Anakinra 100mg subcutaneous injection for 5 days for the treatment of acute gout attacks~     in patients with chronic kidney disease as defined by a eGFR < 60mls/min/1.73m2 and ≥~     30mls/min/1.73m2.~   "
75524|NCT02578381|"~     Summary of Study Aims~      To assess, in a randomised fashion:~        1. performance of Boston Scientific Pressure Wire versus St Jude Pressure Wire~        2. performance of Boston Scientific Pressure Wire versus Boston Scientific Pressure Wire~        3. performance of St Jude Pressure Wire versus St Jude Pressure Wire~   "
75525|NCT02578368|"~     Previously untreated patients with limited metastatic stage (see protocol for details on~     criteria) will receive 4 cycles of FLOT (5-Fluorouracil, Leucovorin, Oxaliplatin and~     Docetaxel). Patients without disease progression will be randomized 1:1 to receive additional~     chemotherapy cycles (4-8 cycles of FLOT) or surgical resection followed by subsequent~     chemotherapy (4-8 cycles of FLOT). Main objective of the study is overall survival. Most~     important secondary objective is the quality of life under treatment and during follow-up.~   "
75526|NCT02578355|"~     The ultimate goal of this project is to develop a risk score to identify patients with~     vulnerable coronary atherosclerotic plaques, who are prone to suffer acute coronary syndrome.~     Early identification of vulnerable plaques may have an enormous impact on public health~     through primary and secondary prevention of acute myocardial infarction.~      Investigators hypothesize that a risk score that incorporates non-invasive coronary CT~     imaging (calcium score and/or coronary CTA) in combination with clinical characteristics~     (classical risk prediction models) will improve the identification of patients who are at~     highest risk to suffer myocardial infarction or sudden cardiac death.~      The overall goal of the OPeRA project is to develop, implement and validate a novel risk~     assessment tool based on image markers and clinical characteristics to identify patients who~     are at increased risk to suffer myocardial infarction or sudden cardiac death.~   "
75527|NCT02578342|"~     The aim of the study is to investigate the response on cognitive testing of healthy persons~     compared to adults with or without medication against ADHD.~   "
75531|NCT02578290|"~     The goal of the study is to determine whether clinical decision support (CDS) affects the~     number, type, or appropriateness of targeted high-cost radiology images (i.e. MR and CT)~     ordered. The CDS will be delivered in Epic through ACRSelect software, which is a leading~     decision support tool based on the American College of Radiology (ACR) Appropriateness~     Criteria (see http://www.acr.org/Quality-Safety/Appropriateness-Criteria), and presents the~     ACR appropriateness scores for each image on a scale of 1-9 with 1-3 labelled as 'usually not~     appropriate', 4-6 'May be appropriate', and 7-9 'usually appropriate'.~   "
75532|NCT02578277|"~     The purpose of the study is to study the effects of BMS-955176 on the single-dose PK~     parameters of probe substrates caffeine, metoprolol, montelukast, flurbiprofen, omeprazole,~     midazolam, digoxin, and pravastatin~   "
75533|NCT02578264|"~     The study aims to provide a more complete characterization and understanding of the genetic~     causes of and tumor DNA detection potential in colorectal cancer. Ultimately findings of this~     study will be used to develop early detection tests for colorectal cancer that are minimally~     invasive (based on a blood test). It is hoped that reliable, minimally invasive, early~     detection methods will lead to improved screening rates, increased screening safety, longer~     colorectal cancer survival, and overall cost savings.~      In order to assess the test's ability to detect tumor DNA, 25 participants with known~     colorectal cancer who will be undergoing surgical resection of the colon as part of their~     clinical care will be recruited. The investigators will collect blood from participants prior~     to surgery, tumor and normal tissue removed during surgery, a series of blood samples after~     surgery for up to one year and relevant medical records. DNA variants identified in blood~     will be compared against tissue samples. Serial samples will be analyzed to assess the~     variance in amount of circulating tumor DNA across time with standard treatment.~   "
75534|NCT02578251|"~     The aim of this study is to assess whether paracetamol is as effective as pethidine for~     analgesia during the first stage of labor.~   "
75535|NCT02578238|"~     This study is a non-interventional, observational study of Humira® in the treatment of~     pediatric CD as per the New Drug Re-examination Guideline in Korea. This study will be~     conducted in institutions which provide a written agreement to AbbVie Korea, and where the~     use of Humira® for pediatric CD is following their normal medical practice setting. Pediatric~     patients who are prescribed Humira® as per physician's medical judgment in accordance with~     the approved Summary of Product Characteristics (SmPC) will be enrolled in the study. As this~     is a post marketing surveillance, AbbVie is NOT involved in the product supply since the drug~     is being used according to the approved marketing label and is to be prescribed by the~     physician under usual and customary practice of physician prescription.~   "
75536|NCT02578225|"~     This study, which will be conducted at 23 sites representing the determined NUTS-1 regions in~     Turkey, in which all patients who were admitted to clinic or were hospitalized with Heart~     Failure (Acute or Chronic) diagnosis will be enrolled into the study, for a month and on a~     day of the week which will be determined by the site itself, is a national, multi-center,~     observational, epidemiological and cross-sectional study. This study is a local study which~     is planned to be conducted only in Turkey. Included patients of the study will be clinically~     evaluated by the physicians who are maintaining them and will receive the standard medical~     treatment which is determined by their physicians in normal life conditions. No experimental~     intervention or treatment will be received by patients in relation to the enrollment to this~     study. Therefore, this study does not contain a protocol or a pre-determined visit flowchart.~     However, patients with Heart Failure diagnosis should grant their consent to the~     retrospective utilization of their data and questions which will be asked to them about their~     disease history. Provided that the study's design is non-pharmacological observational,~     investigators will treat and follow the patients in accordance with their own medical~     decisions and their best clinical experiences.~      Snapshot Evaluation of Heart Failure in Turkey: Initial Analysis from SELFIE-TR~   "
75537|NCT02578212|"~     In the proposed study, investigators aim to investigate the role of interpersonal trust in~     the conditioned placebo analgesia process with healthy male subjects in a standardized~     experimental heat pain paradigm.~   "
75538|NCT02578199|"~     Motivational interviewing and nutritional counseling for weight loss in primary care.~   "
75539|NCT02578186|"~     The present study was conducted to investigate the impact of diphenhydramine hydrochloride on~     the ability to initiate sleep.~   "
75540|NCT02578173|"~     Purpose: To evaluate the accuracy of the AVERT PLUS to monitor contrast volume used during~     angiographic procedures. This will be a first in man prospective observational study of the~     accuracy of this system to quantify contrast volume used during clinically indicated~     angiography in the cardiac catheterization laboratory.~   "
75541|NCT02578160|"~     This will be a randomized, controlled, parallel-group clinical trial. The aim of this study~     will be to evaluate the effectiveness of Tell-Show-Do Behavior Management Technique versus~     a Conventional technique (covering the patient's vision) during an inferior alveolar and~     lingual nerve block in preschool children referred for treatment at the School of Dentistry,~     University of Sao Paulo, Brazil. The sample will consist of 52 children from 3 years old to 5~     years 11 months old who need dental pulp treatment and / or tooth extraction of primary~     molars. Preschool children with no history of allergies to Lidocaine anesthetic or~     systemic/neurological diseases and who did not take local anesthesia before the study will be~     include in this research.~   "
75542|NCT02578147|"~     The purpose of this study is to have girls play new computer games designed for middle school~     children and not yet available to the public. The investigator wants to know what girls think~     about these games. The investigator also wants to learn about the health behavior of 7th~     grade girls of Hispanic/Brazilian/Latino origin, and the investigators want to test the~     Mighty Girls program in Miami. Half of the girls in JUEGA will be given the Mighty Girls~     program and the investigators want to know if this program reduces behavior that puts girls~     at risk for having sex, drinking, and using drugs. The program tries to reduce this risk by~     helping girls learn skills to make wise choices, even when their friends have other ideas or~     want them to make more risky choices This goal is important because US statistics indicate~     that Hispanic teens are at risk for teen pregnancy and Miami has one of the highest HIV and~     AIDS rates in the United States. The investigator wants to find out whether the Mighty Girls~     program is as effective in Miami-Dade County Public Schools as it was when tested in one of~     Orlando's Orange County Public Schools.~   "
75543|NCT02578134|"~     Scientific evidence of conservative management of individuals with plantar fasciosis is~     sometimes conflicting. There is evidence that regular exercise programs are effective for~     this pain condition. The inclusion of other therapeutic modalities is still controversial.~     Some authors have suggested that the use of US-guided percutaneous electrolysis (EPE®) maybe~     useful for the management of chronic tendinopathies; however, no study has investigated the~     potential placebo effect of this intervention. The objective of this randomized clinical~     trial is to determine the effectiveness of US-guided percutaneous electrolysis (EPE®) versus~     sham US-guided percutaneous electrolysis for the management of patients with plantar~     fasciosis for pain, function, and disability.~   "
75544|NCT02578121|"~     The purpose of this study is to determine the efficacy of Ixazomib when combined with~     Pomalidomide and Dexamethasone, in terms of overall response rate in subjects with relapsed~     Multiple Myeloma~   "
75545|NCT02578108|"~     Chronic painful knee OA is a major cause of disability in older adults. In patients whose~     symptoms are refractory to conservative management but who do not wish to undergo TKA or,~     alternatively, are not operative candidates, genicular nerve RFA represents a promising~     treatment option.~      Investigators will determine if patients with chronic painful knee osteoarthritis experience~     meaningful and long-term improvement in pain, function, and analgesic use, as well as~     prevention of TKA after RFA of the genicular nerves. Investigators will also determine~     whether zero versus one set of diagnostic genicular nerve blocks~      Answering these questions will help determine if genicular nerve RFA is indeed a worthwhile~     treatment for chronic painful knee OA. Additionally, this will help determine the optimal~     diagnostic protocol for patient selection for this procedure, which has implications for~     improving treatment success rates, preventing unnecessary procedures, and decreasing~     healthcare cost savings.~   "
75546|NCT02578095|"~     This is a randomized, double-blind, parallel group, placebo-controlled, multicenter study to~     investigate the safety, tolerability, and efficacy of VK5211 after 12 weeks of treatment.~      Males and females ≥65 years old who are ambulatory and recovering from a hip fracture will be~     eligible for participation 3-7 weeks post-injury.~   "
75547|NCT02578082|"~     This multiple-center, nonrandomized, open label, parallel group, single dose study will be~     conducted in male and female subjects with normal renal function or severe (eGFR <30~     mL/min/1.73 m2) renal impairment to evaluate the effect of renal impairment on the~     pharmacokinetics (PK) of TD 4208.~   "
75548|NCT02578069|"~     Prospective, multi-center, randomized 1:1 single blind trial using NOVA sirolimus eluting~     stent versus Apollo bare metal stent conducted in approximately 15 interventional neurology~     centers in China. The study was sponsored by Sino Medical Sciences Technology Inc.~   "
75549|NCT02578056|"~     Pelvic organ prolapse (POP) is a public health problem worldwide, affecting about 30 %. It~     implies physical, psychological and social losses. A frequent complication after surgeries~     for POP is developing de novo stress urinary incontinence (SUI). SUI and POP have similar~     pathophysiology and therefore it is common to coexist in the same patient. De novo SUI has a~     prevalence 11-44 % after surgical correction of genital prolapse. Occult urinary incontinence~     (OUI) is considered the major risk factor for postoperative SUI. Studies on this topic show~     conflicting results. In a recent meta-analysis on this subject, Maher et al concluded that~     the value of performing any anti- incontinence procedure in continent women undergoing~     prolapse surgery remains unknown.~      The aims of this study are to evaluate whether the association of a transvaginal tape (TVT®)~     in continent patients undergoing surgery for prolapse decreases the risk of de novo SUI and~     if it implies an improvement in their quality of life. The secondary endpoints are to assess~     the complications associated with this procedure, as irritative symptoms and voiding~     dysfunction postoperatively and assessing the ability of stress testing with reduced POP and~     urodynamics in predicting the risk of de novo SUI. This study will be a prospective,~     multicentric, randomized experimental study.~      Patients with anterior or apical prolapse stages 3 and 4 (POP - Q) will be invited to~     participate in the study. The study will assess these patients for staging of prolapse, the~     presence of occult urinary incontinence and quality of life. Selected patients will be~     randomized to perform correction of genital prolapse and prophylactic anti-incontinence~     procedure or correction of genital prolapse only. Patients will be assessed 3, 6 and 12~     months after surgery. Postoperative evaluation will be similar to preoperative. The exclusion~     criteria are: complaint or diagnosis of stress urinary incontinence before reduction of the~     prolapse, previous surgery for incontinence or pelvic organ prolapse, hypocontractility~     detrusor in urodynamics and inability to understand and give informed consent.~   "
75550|NCT02578043|"~     The objectives of this study are to evaluate the therapeutic equivalence and safety.~   "
75551|NCT02578030|"~     To provide additional, required information on the pharmacokinetic profile of SHP465 in the~     targeted population (children and adolescents aged 6-17 years of age with ADHD).~   "
75552|NCT02578017|"~     HU is an FDA approved medication for the treatment of SCD. Many studies have shown that HU~     can reduce SCD related symptoms, but only 50% of patients take it as often as they should.~     This limits how much HU can help reduce SCD symptoms.~      Researchers are interested to see if electronic directly observed therapy (Mobile DOT), a~     program that uses cell phone reminder messages, videos, feedback messages, and incentives~     will help patients with SCD take HU as prescribed.~   "
75553|NCT02578004|"~     Development of pressure ulcer (PU) is complex and multifactorial. The association of a~     constituted PU and of clinical / biological major elements is demonstrated and justifies.~     Prevention of PU is an important health priority, one that requires clear identification of~     risk factors.~   "
75554|NCT02577991|"~     Local application of steroids in ACDF surgery will lead to decreased incidence of dysphagia~     compared to intravenous steroids or a control group~   "
75555|NCT02577978|"~     The purpose of this study is to compare objective and subjective measures of knee stability~     following total knee arthroplasty with a medial pivot design vs. a posterior stabilized~     design.~   "
75575|NCT02577718|"~     The objective of this Phase I/II pilot study is to evaluate the safety and effectiveness of a~     non- antibiotic chelator based lock solution that contains nitroglycerin in combination with~     sodium citrate and ethanol (NiCE lock solution) for prevention of central line associated~     bloodstream infection (CLABSI).~        -  The primary objective of this study is to evaluate the safety and estimate the rate of~          adverse events associated with the NiCE lock solution.~        -  The second primary objective is to estimate the rate of CLABSI in patients receiving the~          NiCE lock solution.~   "
75589|NCT02577536|"~     PregSource uses a crowd-sourcing approach, asking pregnant women to enter information~     regularly and directly about their pregnancies throughout gestation and the early infancy of~     their babies into online surveys and trackers via a website and/or mobile application~     (app). In exchange, participants can track their data over time, print out reports to share~     with their healthcare team, and see how they compare to other women. In addition, PregSource~     will provide participants with links to trusted, evidence-based information about pregnancy~     management, issues, and complications.~   "
75556|NCT02577965|"~     Recent studies suggest important gender differences in the pathophysiology and prognosis of~     ST-segment elevation myocardial infarction (STEMI). This is the first prospective controlled~     study to assess gender differences in the mechanism of plaque rupture/erosion and thrombus~     formation in patients presenting with STEMI treated with primary angioplasty. Gender-related~     mechanisms of plaque rupture or erosion will be investigated using a combination of~     Quantitative Coronary Angiography (QCA), high resolution Optical Coherence Tomography (OCT)~     of the culprit vessel and histopathology analyses of thrombus aspirates of the infarct~     related lesion, performed by independent core laboratories, blinded to group (male or female)~     and clinical variables.~      In OCTAVIA; enrollment in a 1:1 ratio according to gender group will be ensured by a~     computer-assisted matching algorithm for gender and age (< 50, 51-70, and > 70 years).~     Matching has the purpose to enable enrollment of an even number of male and female patients~     in balanced age groups. This type of dynamic algorithm is appropriate when the composition of~     the referral population is not known in advance.~      The sample size for the OCTAVIA study was calculated on the basis of per patient stent strut~     coverage (a continuous variable with right skewed distribution) with mean of 97.0% and~     standard deviation of 4.0% in men, versus mean of 95.0% and standard deviation of 4.0% in~     women, following XIENCE PRIME™ Everolimus Eluting Coronary Stent System implantation. Thus,~     aiming for a 5% 2-tailed superiority alpha, an 80% power, and assuming a 1:1 enrollment~     according to gender, a total of 64 patients per group should be enrolled. Anticipating a 10%~     dropout rate due to patients lost to follow-up and inadequate imaging (included major side~     branch sections), the total enrollment is set at 70 patients per group (total population of~     140 subjects).~   "
75557|NCT02577952|"~     Lipodystrophy Connect is an online survey tool designed to collect demographic data and~     health information from individuals with Lipodystrophy.~   "
75558|NCT02577939|"~     The primary objective of this study is to demonstrate the efficacy of a pre-transplant,~     interval exercise training (IET) intervention, in increasing peak oxygen uptake (VO2peak)~     scores on cycle ergometry. This study will have a lead-in phase to ensure that IET is~     feasible in this population. Secondary objectives include documenting the safety of IET in~     this population, evaluating the correlation of VO2peak with other methods of measuring~     pre-transplant cardiorespiratory performance, comparing the 6 minute walk distance (6MWD) pre~     and post IET, and establishing the feasibility of the 6MWD when performed unsupervised by a~     health care professional.~      Eligible patients include 40 evaluable autologous (n=20) and allogeneic (n=20; 10 full~     intensity and 10 reduced intensity) transplant patients deemed appropriate for exercise~     intervention by their treating physician. The investigators will enroll no more than 50~     patients onto this trial. Results of this study will inform a randomized, multi-site study of~     a pre-transplant exercise intervention.~   "
75559|NCT02577926|"~     The Philadelphia chromosome negative myeloproliferative neoplasms (MPN) comprise a group of~     clonal hematological malignancies that are characterized by chronic myeloproliferation,~     splenomegaly, different degrees of bone marrow fibrosis, and disease-related symptoms~     including pruritus, night sweats, fever, weight loss, cachexia, and diarrhea. In addition,~     due to elevated numbers of leucocytes, erythrocytes and/or platelets, the disease course can~     be complicated by thromboembolic disease, hemorrhage, and leukemic transformation as well as~     myelofibrosis.~      Patients with polycythemia vera (PV) typically harbor an increased number of blood cells from~     all three hematopoietic cell lineages due to clonal amplification of hematopoetic stem cells,~     while patients with essential thrombocythemia (ET) typically show a predominant expansion of~     the megakaryocytic lineage. Most patients with PV below the age of 60 years are currently~     being treated with acetylsalicylic acid +/- phlebotomy only, and patients with low-risk ET~     have an almost normal life expectancy and often do not require specific treatment. However,~     PV- as well as ET-patients with a higher risk for complications require cytoreductive~     treatment. In addition, constitutional symptoms can be unbearable to patients even in the~     absence of bona fide high risk factors, and these patients may similarly benefit from~     antineoplastic therapy.~   "
75560|NCT02577913|"~     This study compares the risks of short- and long-term use of FC Patch Low with~     levonorgestrel-containing combined oral contraceptives (COC-LNG) in a study population~     representative of the actual users of the individual preparations. FC Patch Low is a~     transdermal contraceptive patch applied once a week for three consecutive weeks followed by a~     break of one week (21/7). One patch contains 2.1mg gestodene and 0.55mg ethinyl estradiol,~     which is equivalent of releasing 0.06mg gestodene and 0.013mg ethinyl estradiol per 24 hours.~   "
75561|NCT02577900|"~     The purpose of this study is to determine whether nanocrystalline silver dressing, manuka~     honey dressing and conventional dressing are effective in the treatment of diabetic foot~     ulcer.~   "
75562|NCT02577887|"~     The purpose of this study is to characterize the utilization of diagnostics capabilities in~     St. Jude Medical pacemakers to manage patients with a standard bradycardia pacing indication.~   "
75563|NCT02577874|"~     This study is designed to compare the responses to an oral glucose challenge between people~     of European and Chinese heritage (essential participants in the European arm must have tow~     European parents and likewise for the Chinese participants).~   "
75564|NCT02577861|"~     The purpose of this trial is to confirm the efficacy of Holoclar at one year after the first~     treatment in patients suffering from moderate to severe LSCD (Limbal Stem Cell Deficiency)~     secondary to ocular burns. In case of failure of the treatment and upon clinical indication~     of the Principal Investigator, a second transplant with Holoclar will be offered if~     eligibility will be confirmed. The efficacy of two treatments with Holoclar at one year after~     the last treatment will be also evaluated. All patients will be followed-up for 12 months~     after each implant to determine the treatment efficacy by an Independent Assessor.~   "
75565|NCT02577848|"~     The investigators planned to evaluate the effects of liraglutide on left ventricular function~     in patients with non-ST-segment elevation myocardial infarction (NSTEMI).~   "
75576|NCT02577705|"~     The goals of the The Building Wealth and Health Network (The Network) are to develop and~     rigorously test an asset building model that will build financial, social and human capital~     through asset building, financial education and trauma-informed peer support. Program~     components include: 1) Matched savings accounts; 2) Financial literacy classes; and 3) Peer~     support groups using the Sanctuary ® trauma-informed approach to social services. This~     program is offered in partnership with the Department of Public Welfare of the Commonwealth~     of Pennsylvania. The program elements will fulfill work requirements for the program called~     temporary Assistance for Needy Families (TANF).~      The hypothesis is that the program's combination of services will result in improved economic~     security through boosting income, increasing assets, and building a supportive social~     network, that then translates to better health outcomes.~   "
75566|NCT02577835|"~     This Registry is an investigator-initiated, international, multicenter, observational,~     prospective study aiming at: i) evaluating non-invasive 24-h ambulatory blood pressure and~     arterial stiffness estimates (through 24-h pulse wave analysis) in hypertensive subjects; ii)~     assessing the changes in estimates following treatment; iii) weighing the impact of 24-h~     pulse wave analysis on target organ damage and cardiovascular prognosis; iv) assessing the~     relationship between arterial stiffness, blood pressure absolute level and variability, and~     prognosis. Approximately 2000 subjects, referred to 20 hypertension clinics for routine~     diagnostic evaluation and follow-up of hypertension, will be recruited. Data collection will~     include ambulatory blood pressure monitoring, performed with a device allowing simultaneous~     non-invasive assessment of blood pressure and arterial stiffness, and clinical data~     (including cardiovascular outcomes). A web-based telemedicine platform will be used for data~     collection. Subjects will visit the centers at 6-12 month intervals. First follow-up results~     are expected to be available in the next 2-years. The results of the Registry will help~     defining the normalcy thresholds for current and future indices derived from 24-h pulse wave~     velocity, according to outcome data. They will also provide supporting evidence for the~     inclusion of such evaluation in recommendations on hypertension management.~   "
75567|NCT02577822|"~     The purpose of this study is to determine the viability of short femoral stems as an~     alternative to standard-length stems in total hip arthroplasty.~   "
75568|NCT02577809|"~     This is an interventional drug trail to evaluate the effect of different intrathecal opioids~     on post-operative pain experiences in women who have undergone caesarean section surgery.~   "
75569|NCT02577796|"~     Radial artery access is increasingly becoming popular among interventional cardiologists for~     patients undergoing percutaneous coronary intervention(PCI)/ diagnostic angiography secondary~     to its low complications rates. However, it is frequently associated with the spasm of the~     radial artery which can lead to difficulty in catheter manipulation during the procedure and~     potentially leading to vessel trauma. This vessel trauma can cause activation of coagulation~     system and formation of clot and subsequently the occlusion of radial artery. In this study~     the investigators intend to find the association of radial artery spasm with the future~     development of radial artery occlusion in patients who undergo PCI via radial access.~   "
75570|NCT02577783|"~     The purpose of this study is to determine whether doxorubicin hydrochloride liposome is~     superior to doxorubicin when combined with bortizomib and dexamethasone for treating patient~     with initially diagnosed multiple myeloma.~   "
75571|NCT02577770|"~     This is a single center, double blind, randomized, parallel-group study to assess the effect~     of 200mg caffeine,400mg caffeine and decaffeinated on acupuncture analgesia with the human~     pain model.~   "
75572|NCT02577757|"~     Proceed to an analysis of sensitivity and specificity results of the fMRI language network~     obtained in two ways: by providing a conventional language test and independent component~     analysis. These two methods will be compared to the reference method what the cortical~     intraoperative mapping.~   "
75573|NCT02577744|"~     Obesity is a non-communicable chronic disease of multifactorial, involving biological,~     historical, ecological, economic, social, cultural and political. Currently, bariatric~     surgery is considered an effective method of refractory obesity treatment, and only severe~     obesity effective treatment that leads to reduced long-term weight. It is well documented in~     the literature regarding the association of abdominal surgery and the incidence of~     respiratory complications and its main characteristics are: atelectasis, pneumonia,~     respiratory dysfunction and pleural effusion. All these respiratory complications can be~     minimized or avoided with the use of a respiratory therapy care protocol, since the pulmonary~     atelectasis is considered the main cause of complications. An arsenal of resources to~     physical therapy lung expansion, among these, the application of positive pressure through a~     valve EPAP (Expiratory positive airway Pressure) and the use of noninvasive ventilation, and~     aims to prevent and / or improve the complications resulting from postoperative. The~     electrical impedance tomography (EIT) is an alternate to allow assessment of the respiratory~     system, without suffering the same interference conditions of patients, such as pain and bed~     rest. TIE consists of a method that measures passively regional lung ventilation. The aim of~     this study is to compare the effects of the application of EPAP and NIV on pulmonary~     ventilation we post bariatric surgery. This is a randomized controlled trial where patients~     will be divided into two groups: EPAP and NIV and assessed by spirometry, manometer and TIE.~     The techniques will be applied in the 1st and 2nd postoperative day where they will be~     evaluated before, during and after the application of the techniques.~   "
75574|NCT02577731|"~     Traumatic injury is a leading cause of morbidity and mortality in young adults, and remains a~     substantial economic and health care burden. Despite decades of promising preclinical and~     clinical investigations in trauma, investigators understanding of these entities is still~     incomplete, and few therapies have shown success. During severe trauma, bone marrow~     granulocyte stores are rapidly released into the peripheral circulation. This release~     subsequently induces the expansion and repopulation of empty or evacuated space by~     hematopoietic stem cells (HSCs). Although the patient experiences an early loss of bone~     marrow myeloid-derived cells, stem cell expansion is largely skewed towards the repopulation~     of the myeloid lineage/compartment. The hypothesis is that this 'emergency myelopoiesis' is~     critical for the survival of the severely traumatized and further, failure of the emergency~     myelopoietic response is associated with global immunosuppression and susceptibility to~     secondary infection. Also, identifying the release of myeloid derived suppressor cells~     (MDSCs) in the circulation of human severe trauma subjects. This process is driven by HSCs in~     the bone marrow of trauma subjects. Additionally, MDSCs may have a profound effect on the~     nutritional status of the host. The appearance of these MDSCs after trauma is associated with~     a loss of muscle tissue in these subjects. This muscle loss and possible increased catabolism~     have huge effects on long term outcomes for these subjects. It is the investigator's goal to~     understand the differences that occur in these in HSCs and muscle cells as opposed to~     non-injured and non-infected controls. This work will lead to a better understanding of the~     myelopoietic and catabolic response following trauma.~   "
75608|NCT02577289|"~     Evaluation of bone quantity in open sinus lift technique with space maintaining using~     platelet rich fibrin (PRF) as sole augmentation material versus nano crystalline~     hydroxyapatite with simultaneous placing of implants.~   "
75577|NCT02577692|"~     High inspiratory oxygen fractions are known to induce oxidative stress and lipid~     peroxidation. The degrading products of oxidative stress induced lipid peroxidation are in~     part volatile and appear in breath where they can be measured non-invasively. However, there~     is lack of knowledge on the correlation of blood and breath biomarkers of oxidative stress.~      This study aims to investigate the effects of a high inspiratory oxygen fraction on oxidative~     stress in healthy volunteers. The primary outcome is the appearance of exhaled breath~     biomarkers of oxidative stress by electrochemical sensors and ion mobility mass spectrometry.~     Secondary outcomes are changes in oxidative stress biomarkers in blood and their relationship~     to breath biomarkers.~   "
75578|NCT02577679|"~     The aim of this case control study is to explore the possible association between periodontal~     destruction and serum anti-CCP antibodies in RA patients and healthy subjects.~   "
75579|NCT02577666|"~     A dearth of information is available regarding how best to intervene with substance use~     disordered homeless mothers and their young children. This proposal follows from the~     promising findings of a rigorously developed ecologically based treatment that offers a~     comprehensive intervention for the multiple needs of this vulnerable population. Such~     research attention is needed in order to effectively intervene in the substance use, HIV~     risk, mental/physical health and homeless trajectory of these women and their young children.~     Further, if successful, this intervention may be transportable to communities without crisis~     shelters and to homeless mothers who do not access shelter or residential treatment services.~   "
75580|NCT02577653|"~     Determine the posturographic characteristics of eccentric, isometric and concentric movements~     in healthy subjects as well as in subjects with chronic, orthopedic conditions / pain not~     involving the lower extremities. The squatting movement (going down from a stand up position,~     bending the ankle, knee and hip joints, and then returning to the stand up position, while~     not lifting the feet from the supporting ground surface) is a simple motion that involves all~     three types of movements: eccentric (the going down), isometric (holding the down position~     for a couple of seconds) and concentric (the coming up). It is hypothesized that non-healthy~     subjects will not have smooth movements, and posturography could be used to separate~     between healthy and non-healthy subjects.~   "
75581|NCT02577640|"~     Dietary Soy Isoflavones in Chronic Pancreatitis: Investigating the Anti-inflammatory Effects~     of Food Innovation Science on Gastrointestinal Disease~   "
75582|NCT02577627|"~     This is a retrospective observational, open label study to evaluate and prospectively~     validate in a blind manner the accuracy of predicting treatment outcomes by PrediCare in~     individual patients with Non-Small Cell Lung Cancer, Small Cell Lung Cancer,~     Castration-Resistant Prostate Cancer, Breast Cancer & Colon Cancer under the treatment with~     the mono- and combination drug protocols for the 1st and 2nd line treatment, approved to the~     market as a Standard of Care~   "
75583|NCT02577614|"~     The purpose of this pilot study is to evaluate the feasibility of the prophylactic~     administration of Factor VIII Inhibitor Bypass Activity (FEIBA) at termination of~     cardiopulmonary bypass (CPB) period. Specifically, the proposed study is designed to~     demonstrate the potential role of FEIBA administration in reducing the need for allogeneic~     transfusion to treat refractory coagulopathy in high risk patients.~   "
75584|NCT02577601|"~     The purpose of this research study is to determine if taking a birth control pill effects how~     well an emergency contraceptive pill called Ulipristal acetate (UPA) works. This type of~     emergency contraceptive is the most effective oral method available. However, this medication~     is an anti-progestin and most regular forms of birth control contain progestin (a female~     hormone). It is unknown if taking the two close together may make the emergency contraceptive~     not work well. The overall goal of this research is to improve the effectiveness of~     contraception for women and to better counsel women.~   "
75585|NCT02577588|"~     The study Phase I trial of Adoptive T cell Therapy with Activated P53 specific T cells for~     Treatment of Advanced Colorectal Cancer is an open label, single arm trial.~   "
75586|NCT02577575|"~     In this study, investigators will examine the behavioral effects and neurophysiological~     mechanisms of the pro-social neuropeptide oxytocin in patients with recent-onset~     schizophrenia. Such research is a necessary first step towards identifying whether intranasal~     oxytocin administration can serve as an adjunct treatment for social impairments in~     schizophrenia.~      Aim 1: To quantify the effects of exogenous oxytocin on social cognition and behavior in~     patients with recent-onset schizophrenia.~      Hypothesis A: Patients and healthy comparison subjects will show enhanced social cognition~     (e.g., improved interpretation of paralinguistic and emotional cues, such as those involved~     in emotional or sarcastic communication) after administration of oxytocin versus placebo.~      Hypothesis B: Patients and healthy comparison subjects will show increased attention to~     others' eyes and patients will exhibit increased facial affect expressivity after~     administration of oxytocin versus placebo.~      Aim 2: To examine the effects of exogenous oxytocin on persistent negative symptoms in~     schizophrenia (PNS) activity in patients with recent-onset schizophrenia.~      Hypothesis A: Patients and healthy comparison subjects will demonstrate increased PNS~     activity during social tasks after administration of oxytocin versus placebo.~      Hypothesis B (exploratory): Patients and healthy comparison subjects' improvements in social~     cognition and behavior will be predicted by the degree to which oxytocin increases their PNS~     activity.~   "
75587|NCT02577562|"~     The Zenith®Fenestrated AAA Endovascular Graft Clinical Study is a clinical investigation~     approved by the US FDA to study the safety and effectiveness of the Zenith® Fenestrated AAA~     Endovascular Graft in the treatment of abdominal aortic and aorto-iliac aneurysms.~   "
75588|NCT02577549|"~     This study aims to develop and demonstrate the effectiveness of a systematic, practical,~     cost-effective diet-induced weight loss and exercise intervention in both urban and rural~     communities that can reduce pain and improve other clinical outcomes in knee OA patients.~     This pragmatic community-based trial will determine if the investigators previous findings~     translate to real-world settings and will address common concerns about barriers to~     effectiveness/ implementation.~   "
75601|NCT02577380|"~     The overarching goal of this study is to pilot an approach to HIV testing and counseling~     (HTC) that addresses intimate partner violence. The results of the study will fill an~     important gap in the literature and contribute to efforts by Kenyatta National Hospital in~     Nairobi, Kenya—and the HIV and sexual and reproductive health field globally—to better~     address intimate partner violence in our work.~   "
75590|NCT02577523|"~     This is a multicenter, parallel-group, rater-blinded, randomized clinical study in subjects~     with advanced PD investigating the efficacy, PK, safety and tolerability of continuous SC~     infusion of 2 dosing regimens of ND0612H, a solution of LD/CD delivered via a pump system as~     a continuous SC infusion, compared to standard oral LD/CD. After screening, subjects will~     undergo 1 day of standard oral LD/CD inpatient dosing followed by 2 days of inpatient~     treatment with 1 of 2 randomly allocated (1:1 randomization ratio) dosing regimens of ND0612H~     continuous SC infusion. Subjects will then continue on a maintenance dose of the assigned~     ND0612H dosing regimen for the next 25 days. A safety visit will be performed 4 weeks after~     the last SC administration of the study drug for a total of about 2.5 months of participation~     for each subject enrolled into the trial.~   "
75591|NCT02577510|"~     Background~      The sensation on the outside of portion of our thighs is provided by a nerve called the~     lateral femoral cutaneous nerve (LFCN). The investigators can inject freezing around the~     nerve to reduce the feeling around the thigh (i.e. anesthesia). Anesthesia, or freezing, of~     the lateral femoral cutaneous nerve can reduce pain for patients having A) hip and knee~     surgery [1,2], B) removal of a skin graft [3], and C) wound care. In addition, damage to the~     LFCN (i.e. Meralgia Paresthetica) has been associated with body armour and gun belt use in~     military and police personnel [4]. Although generally a benign condition, compression or~     injury to this nerve can be painful and require treatment. In addition, the actual~     variability in sensory distribution for this nerve has not been elucidated in a topographical~     fashion and will be measured in this study.~      Finding the most efficient and effective method for anesthesia of the LFCN can improve and~     positively impact the quality of pain control for patients. Ultrasound has improved the~     accuracy and efficiency of various other regional anesthesia techniques, and could also~     impact the safety. Therefore the investigators hypothesize that ultrasound guided lateral~     femoral cutaneous nerve block using the subinguinal technique will be statistically more~     efficacious and efficient when compare to neurostimulation based blockade.~   "
75592|NCT02577497|"~     The primary objective of the study is to show that ventilation heterogeneity identified by~     hyperpolarized helium-3 lung MRI is prevalent children with poorly controlled asthma despite~     guidelines-based treatment with ICS. The secondary objective is to demonstrate whether or not~     eight weeks of treatment with extra-fine particle ICS (HFA-BDP) improves ventilation~     heterogeneity compared to treatment with a coarse particle ICS (fluticasone HFA or dry~     powder).~   "
75593|NCT02577484|"~     This study will assess the differences between Fractional Flow Reserve (FFR) measurements~     made by the Navvus catheter and a commercially available pressure guidewire in up to 240~     subjects where FFR is clinically indicated. All subjects will receive diagnostic treatment~     according to clinical indications and center standard practice.~   "
75594|NCT02577471|"~     In this prospective study the function of gastrointestinal tract was assessed using~     constipation questionnaire (Rome criteria and bowel function index).~   "
75595|NCT02577458|"~     This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability,~     Pharmacokinetics, and Preliminary Efficacy of CM082 in Combination with Everolimus in Chinese~     Patients With Advanced Renal Cell Carcinoma.~   "
75596|NCT02577445|"~     The aim of this post market study is to assess the impact of sleep-disordered breathing on~     the well-being of patients according to the treatment chosen, i.e. with or without~     implantation of the remedē® system to treat sleep-disordered breathing.~   "
75597|NCT02577432|"~     Background: Poor spinal anaesthesia block is common and is difficult to manage; so a~     technique to minimize its incidence is advisable. Hypotension is the commonest problem with~     spinal anesthesia. Multiple trials to prevent or combat hypotension using positional changes,~     fluid therapy and the use of vasopressors were tried. However, the drug choice and mode of~     administration as either bolus or infusion is still a matter of debate.~      Objectives: To compare the outcome of spinal injection of hyperbaric bupivacaine and fentanyl~     separately to standard injection of mixed fentanyl with hyperbaric bupivacaine.~      Design: A randomized, controlled clinical trial.~      Setting: Single medical center from 5/2013 to 10/2014.~      Patients & Methods: 124 parturient scheduled for elective cesarean section (CS) were randomly~     allocated into two groups, each 62 parturient: Group M received spinal anesthesia using 10 mg~     bupivacaine 0.5% premixed with 25 µg fentanyl in the same syringe and Group S received 25 µg~     fentanyl in one syringe and 10 mg bupivacaine 0.5% without barbotage in a second syringe.~     Intravenous fluid co-load with 15 ml/kg warm lactated ringer solution was started as fast~     drip during, and continued after spinal anesthesia.~      Patients were monitored for hemodynamic parameters, time of sensory onset and height of~     maximum sensory block, lower limb motor blockade was scored using modified Bromage scale and~     the frequency of side effects.~   "
75598|NCT02577419|"~     Breast milk is the reference normative standard for infant feeding. When an infant is~     diagnosed with chylothorax, provision of breast milk must be temporarily discontinued due to~     the presence of long chain triglycerides (LCT) that contribute to persistent chylous~     drainage. In its place, the infant is prescribed a therapeutic formula high in medium chain~     triglycerides (MCT) as treatment for chylothorax. Families and health care providers are~     interested in using breast milk, in a modified fat form, as treatment for chylothorax~     instead. This study will assess growth in infants receiving one of two nutrient enriched~     modified fat breast milk (MFBM) treatments for chylothorax. If either of the proposed~     nutrient enrichment methods support growth, MFBM will become a standard chylothorax treatment~     option for infants at SickKids.~   "
75599|NCT02577406|"~     This is an international, multicenter, open-label, randomized, Phase 3 study comparing the~     efficacy and safety of AG-221 versus conventional care regimens (CCRs) in subjects 60 years~     or older with acute myeloid leukemia (AML) refractory to or relapsed after second- or~     third-line AML therapy and positive for an isocitrate dehydrogenase (IDH2) mutation.~   "
75600|NCT02577393|"~     The investigators conducted this phase II study of EGCG therapy protection of the esophagus~     from damage induced by radiotherapy. In order to observe the effectiveness of EGCG,~     esophageal toxicity was recorded weekly using a grading scale based on symptomatology,~     following the Radiation Therapy Oncology Group (RTOG) scoring system. Patient-reported pain~     related to esophagitis was measured using the numerical rating scale (NRS) every week from~     EGCG application to 2 weeks after the end of radiotherapy. The scales are translated into~     Chinese and guides in Chinese are developed instructing how to use the scales and perform the~     assessments.~   "
75611|NCT02577250|"~     The relationship between depression and trauma is well established. Co-occuring depression~     and post-traumatic stress disorder (PTSD) are associated with more severe symptoms and lower~     levels of functioning. Veterans with both depression and PTSD have been shown to be at much~     higher risk of suicide than individuals with only one of these disorders. Ketamine has been~     shown to have rapid antidepressant effects and also therapeutic action over PTSD symptoms.~     The purpose of this study is to see whether ketamine, when given as repeated infusions, can~     produce quick and sustained improvement in depression and PTSD symptoms for individuals who~     have not had their symptoms effectively treated by current treatments.~   "
75612|NCT02577237|"~     Patients with head and neck cancer and their caregivers face many challenges. These include~     learning about cancer and its treatment, coping with symptoms from illness and treatment side~     effects, making adjustments to usual activities, and managing the emotional effects of having~     a serious illness. This study tests whether different forms of education and support can help~     family caregivers feel better prepared. To find out if education about caregiving and~     different kinds of support are effective, this study wants to compare approaches.One group~     includes caregivers who will receive an education and support program throughout radiation~     treatment in addition to usual care by their doctors and nurses. The other group receives an~     educational booklet about caregiving in addition to usual care by their doctors and nurses.~     The caregiver also completes surveys about his or her emotions, distress, confidence as a~     care giver, and quality of life. In addition, the study asks the caregiver questions about~     his or her age, race, ethnicity, marital status, employment status, education, annual~     household income, and current living arrangements. This pilot study will only be offered at~     the Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive~     Cancer Center Main Campus.~   "
75613|NCT02577224|"~     Blepharospasm and hemifacial spasm are debilitating conditions which significantly impact on~     patient quality of life. Cyclical treatment with botulinum toxin injections offers temporary~     relief but the duration of treatment efficacy is variable. The standard model of patient care~     defines routine fixed- time based scheduled treatment cycles which may lead to unnecessarily~     frequent treatment for some patients and experience of distressing symptoms in others if~     symptoms return before the scheduled follow up period. The present study aims to compare a~     patient-initiated model of care, where patients determine treatment timing, with the standard~     model of care by using a two-arm randomised controlled trial design. It is expected that~     patients able to initiate their own treatment will experience less variation in disease~     severity and disability over a treatment cycle as they will be empowered to take the~     initiative when they feel they need to have treatment. A range of other outcomes will be~     assessed including: confidence and satisfaction in the service, depression, anxiety, quality~     of life and, illness and treatment beliefs. If the patient-led care model is shown to be~     effective in preventing distress and reducing disability in these populations; and is found~     to be acceptable to service users, this will have significant implications for service~     organisation across the NHS.~   "
75614|NCT02577211|"~     The aim of this study is to compare two nutritional regimes in critically ill patients.~     Patients will be randomized to standard care (25 kcal per kg) or to hypocaloric nutrition (15~     kcal per kg). Both regimes will recive 1,7 g/Kg/dia The main outcome will be the SOFA~     (sequential organ failure assessment) score. The hypothesis is that hypocaloric hyperproteic~     diet decreases the incidence of organic failure in these patients.~   "
75615|NCT02577198|"~     Computerized decision support systems (CDSSs) are information technology-based software that~     provide health professionals with actionable, patient-specific recommendations or guidelines~     for disease diagnosis, treatment, and management at the point-of-care. CDSSs may be~     integrated with patient electronic health records (EHRs) and evidence-based knowledge.~   "
75616|NCT02577185|"~     The purpose of this study is to evaluate the anti-psoriatic effect of injected Botulinum~     toxin type A compared to that of injected vehicle.~   "
75617|NCT02577172|"~     The present study examine the effects of an aerobic and strength training program on~     cardiorespiratory fitness in testicular cancer (TC) patients during chemotherapy. Half of the~     participants will receive the exercise program and the other half will receive one individual~     lifestyle counseling session. The investigators hypothesize that TC patients in the exercise~     group will have less reduction in cardiorespiratory fitness during chemotherapy treatment~     compared to patients in the control group.~   "
75618|NCT02577159|"~     The investigators will investigate whether dapagliflozin (FORXIGA) might improve lipoprotein~     metabolism as well as hyperglycemia in Japanese patients with type II diabetes mellitus whose~     HbA1c levels are less than 7.0% (from 20 to 65 years of age). The investigators will examine~     changes of fasting lipoprotein profile including TG, TC, HDL-C, apoB-48 and RemL-C before and~     after the 8 weeks administration of dapagliflozin.~   "
75619|NCT02577146|"~     This is a single institution, prospective study to evaluate the prognostic significance of~     renal and bladder ultrasound with ureteral jet assessment and its utility to evaluate the~     spontaneous stone passage rate of ureteral stones.~   "
75620|NCT02577133|"~     Colic is a term for inconsolable crying happened in the first months of life. Its etiology is~     multifactorial and caregiver and pediatrician generates among other problems: anxiety, risk~     of child abuse as well as economic costs.~      There is now enough evidence for the treatment of colic using probiotics, especially~     Lactobacillus reuteri.~      The investigators study aims to demonstrate the utility for the prevention of colic with L.~     reuteri and thereby avoid the problems caused by this pathology.~      Objective: Compare the number of events of colic among infants with oral probiotic~     Lactobacillus reuteri during the first month of life versus infants with placebo~      Study Design. Double blind, randomized, controlled, 492 neonates of 37-42 gestational age,~     breast or formula fed, will receive L. reuteri 5 drops (1x108 CFU) daily or placebo for 28~     days. The investigators trial will be performed at Naval Hospital in Mexico City.~   "
75621|NCT02577120|"~     This prospective pilot study is to enroll patients with clinically-defined infected wounds.~     Patients enrolled in the study will be followed for 16 weeks for wound closure (Phase A), and~     will then begin Phase B. 265 clinically diagnosed infected burn or chronic wound patients~     will be recruited for this study in Phase A. Based on the expectation that 89% of these~     wounds will heal within 16 weeks of enrollment, 234 of these patients will continue with the~     study for Phase B.~   "
75624|NCT02577081|"~     Neck of femur fractures are common in the elderly and are the source of significant morbidity~     and mortality. This study is based on a new technique developed in Ben Gurion University,~     with which investigators are able to asses the structural 3 dimensional strength of a bone by~     applying a unique simulation on a CAT scan of the bone. The purpose of this study is to~     evaluate the risk of a contralateral neck of femur fracture after the first neck of femur~     fracture and to estimate the potential fracture characteristics.~   "
75625|NCT02577068|"~     Patients undergoing thyroidectomy are suffering not only surgical wound pain but posterior~     neck pain because of neck extension position during the surgery. However, there has been~     little attention of posterior neck pain. Nefopam and Propacetamol have different~     pharmacodynamics and been used for postoperative pain control in thyroidectomy patients. The~     aim of this study is evaluation of combination effect of Nefopam and Propacetamol for acute~     wound pain, posterior neck pain and chronic pain after thyroidectomy.~   "
75626|NCT02577055|"~     Purpose of this study:~      To establish the equivalence of poly-myomectomy versus Uterine Artery Embolization, in women~     with multiple symptomatic fibroids and no other infertility factor, seeking to conceive.~   "
75627|NCT02577042|"~     Physicians in charge of HIV-infected patients are increasingly being faced to previously~     unrecognized comorbid conditions such as atherosclerosis and cardiovascular events, loss of~     renal function, osteopenia/osteoporosis and bone fractures or non-AIDS-defining cancers~     (1-4). The incidence of these conditions seems to be higher than in the general population~     but there are controversial data about if these diseases appear at a younger age in~     HIV-infected patients.~      The investigators propose a strategy for treatment of elderly HIV-infected patients with a~     double impact on systemic inflammation and age-related co-morbidities by switching the~     protease inhibitors by raltegravir, a integrase inhibitor with a neutral effect on lipid and~     bone metabolism, and adding an statin because of their anti-inflammatory effect. For safety~     reasons, only patients with maintained viral suppression (documented indetectable viral load~     for 1 year or more), and no history of virological failure to integrase inhibitors or~     suspected or documented resistance mutations to the integrase or retrotranscriptase will be~     candidates for the study.~      Interleukin -6 and D-dimer are biomarkers that most strongly predict mortality in treated HIV~     infection and sCD14, sCD163 are soluble markers of monocyte activation that reflect a key~     source of inflammation and coagulation in HIV infection and predict mortality (26,27). For~     that reasons, these markers were chosen to determine changes on them after the introduction~     of the statin and the change of antiretrovirals~   "
75628|NCT02577029|"~     Patients with chronic Hepatitis B Virus (HBV) infection will receive either ARC-520 alone or~     ARC-520 in combination with other treatments such as entecavir (ENT) or tenofovir (TDF)~     and/or pegylated interferon alpha 2a (PEG IFN) therapy, and be evaluated for safety and~     efficacy.~   "
75629|NCT02577016|"~     This is a study to assess the safety and efficacy of the addition of sitagliptin in Japanese~     participants with Type 2 diabetes mellitus (T2DM) who have inadequate glycemic control on~     ipragliflozin, diet, and exercise therapy. The primary hypothesis of the study is that the~     addition of sitagliptin once daily compared with placebo provides greater reduction in~     hemoglobin A1C (HbA1c) as assessed by change from baseline (Week 0) to Week 24.~   "
75630|NCT02577003|"~     This is a study to assess the safety and efficacy of the addition of ipragliflozin once daily~     in Japanese participants with Type 2 diabetes mellitus (T2DM) who have inadequate glycemic~     control on sitagliptin, diet, and exercise therapy. The primary hypothesis for this study is~     that the addition of ipragliflozin compared with placebo provides greater reduction in~     hemoglobin A1C (HbA1c) as assessed by change from baseline at Week 24.~   "
75631|NCT02576990|"~     In this study, participants with relapsed or refractory primary mediastinal large B-cell~     lymphoma (rrPMBCL) or relapsed or refractory Richter Syndrome (rrRS) will receive~     pembrolizumab (MK-3475). The efficacy of pembrolizumab in the treatment of rrPMBCL and rrRS~     will be evaluated. The primary study hypothesis is that intravenous (IV) administration of~     single agent pembrolizumab will result in an Objective Response Rate (ORR) of greater than~     15% using the International Working Group (IWG) response criteria (Cheson, 2007) by~     independent central review.~      Effective with Protocol Amendment 04, enrollment into the rrRS cohort was closed.~   "
75632|NCT02576977|"~     The purpose of this study is to compare the efficacy of pomalidomide and low dose~     dexamethasone with pembrolizumab (MK-3475) to that of pomalidomide and low dose dexamethasone~     without pembrolizumab in terms of Progression-Free Survival (PFS) in participants with~     refractory or relapsed and refractory multiple myeloma (rrMM) who have undergone at least 2~     lines of prior treatment.~   "
75633|NCT02576964|"~     This study will evaluate the efficacy and safety of capecitabine (Xeloda) in combination with~     peginterferon alfa-2a (Pegasys) in participants with advanced liver cancer who have had no~     prior treatment. The anticipated time on study treatment is until disease progression, and~     the target sample size is 43 individuals.~   "
75634|NCT02576951|"~     The purposes of this study are:~        -  To evaluate tolerability of the LY2951742 solution injectable formulation (Part A)~        -  To measure how much of the LY2951742 lyophilized (freeze dried) injectable formulation~          is absorbed into the blood stream and how long it takes the body to get rid of it~          compared to the LY2951742 solution injectable formulation after a single injection under~          the skin (subcutaneous [SC]) (Part B).~      Information about any side effects that may occur will also be collected. Each part of the~     study will last about six months. Participants may only enroll in one part.~   "
75635|NCT02576938|"~     The purpose of this study is to evaluate the safety and effectiveness of Baricitinib in~     eczema.~   "
75636|NCT02576925|"~     The transient diplopias (TD) is defined by a short diplopia. Their etiology may be~     ophthalmological, neurological non-ischemic or of ischemic origin.~      The difficulty is to recognize an ischemic mechanism which imposes emergency cares.~      A clinical score could help the clinician to recognize the etiology of the TD .~   "
75637|NCT02576912|"~     The overall purpose of this study is to examine the effect of pregnenolone (PREG) on the~     acute psychosis-like and cognitive effects of Delta-9-tetrahydrocannabinol (THC). This will~     be tested by pretreating healthy individuals with PREG and then assessing their responses to~     THC.~   "
88318|NCT02411097|"~     To investigate whether preemptive analgesic of femoral nerve block could prevent deep venous~     thromboembolism due to inhibiting the excessive release of neutrophil elastase and~     inflammatory cytokines.~   "
75638|NCT02576899|"~     Veterans with PTSD have high rates of smoking (34%-86% vs. 18% in the general population) and~     have substantial difficulties with quitting tobacco. Only 23% of individuals with PTSD quit~     smoking compared to 50% of the general population. As a result, Veterans with PTSD are at~     high risk of developing severe health problems and poor physical functioning. Fifty percent~     of these long-term smokers will die of a smoking-related cause and on average, will lose 25~     years of their life compared to non-smokers. Despite the significant morbidity and mortality~     associated with smoking, no smoking cessation treatments exist that intensively target PTSD~     symptoms as an obstacle to quit smoking, although this is a significant barrier to quitting~     for many Veterans. In addition, no smoking cessation treatments have a large emphasis on~     improving the functioning of Veterans with PTSD and tobacco dependence, although both PTSD~     and tobacco use negatively affect functioning across physical, mental health, and social~     domains.~      The goal of this SPiRE project is to evaluate Acceptance and Commitment Therapy for Veterans~     with PTSD and Tobacco Use (ACT-PT), which is an acceptance and mindfulness-based smoking~     cessation treatment for Veterans with PTSD and tobacco dependence. ACT-PT specifically~     targets smoking cravings related to PTSD symptoms and memories of trauma, in addition to~     difficulties managing PTSD symptoms. negative affect and nicotine withdrawal symptoms during~     quit attempts. ACT-PT includes structured intervention components that guide Veterans to~     replace smoking as a coping strategy for PTSD symptoms and memories with alternative coping~     strategies (e.g., mindfulness, acceptance). And healthy living activities (e.g., engaging in~     work, expanding social networks, engaging in physical exercise) that are consistent with~     Veterans' values. This emphasis on substantially improving health-related quality of life and~     functioning across several areas makes ACT-PT particularly innovative and different from~     existing treatments. However, research is needed on the relative feasibility, acceptability,~     and efficacy of ACT-PT compared to standard smoking cessation treatments.~      The proposed SPiRE (I21) will involve a randomized clinical trial study of 50 Veteran smokers~     with PTSD and tobacco dependence randomized to one of two different types of psychosocial~     treatment 10 individual sessions of ACT-PT (n= 25) versus 10 individual sessions of the~     American Lung Association's Freedom From Smoking Program [FFS] (n=25) with all participants~     receiving 12 weeks of the nicotine patch. This study has two primary aims: 1) evaluate the~     relative feasibility and acceptability of the two interventions (including ease of~     recruitment, randomization proportion, staff and Veteran acceptance of the treatment,~     retention rates, treatment adherence, fidelity, ease of the assessment process), and 2)~     evaluate the preliminary efficacy of ACT-PT vs. FFS with the primary outcomes of tobacco use,~     PTSD symptoms, health-related quality of life, and functional impairment.~   "
75639|NCT02576886|"~     Participants are being asked to participate in this research study because the participant's~     doctor has ordered a myocardial perfusion SPECT (Single-Photon Emission Computed Tomography)~     scan to look at the blood flow in the participants heart.~      Myocardial perfusion imaging is a proven test that looks at the blood flow to the~     participant's heart after the injection of a radioactive tracer. The standard test requires~     two injections of the radioactive tracer and takes images of the participant's heart at rest~     and after a stress test. It has been proposed that in some cases, patients could have images~     done only after the stress portion of the test and, if normal, the rest images would not need~     to be done. In this case, only one injection of the radioactive tracer would be needed. It~     has further been proposed that adding another stress image made with the participant lying on~     their stomach, will increase the confidence of the reporting doctor in reporting stress~     images.~      The purpose of this study is to find out if the extra information added from the image with~     the participant on their stomach helps the doctor when reporting the test results.~   "
75640|NCT02576873|"~     A retrospective cohort study was conducted in 66 end-stage renal disease patients who~     underwent high-efficiency hemodiafiltration technique in King Chulalongkorn Memorial Hospital~     between 2001-2013 to determine the survival rate as well as other long-term outcome.~   "
75641|NCT02576860|"~     This study evaluates the safety and efficacy of once-daily application of CLS001 topical gel~     compared to vehicle gel in subjects with severe papulopustular rosacea.~   "
75642|NCT02576847|"~     This study evaluates the long-term safety of once-daily application of Omiganan topical gel~     in subjects with severe papulopustular rosacea.~   "
75643|NCT02576834|"~     The literature is characterized by a dearth of information on interventions for homeless~     youth, and no suicide prevention intervention has been tested with these youth. Such focus is~     critical as suicide is the leading cause of death among homeless youth. Therefore, this study~     seeks to address this gap in the research literature with the goal to identify an effective~     strategy to intervene in suicide ideation in this population.~   "
75644|NCT02576821|"~     Hippocampal Sclerosis (HS) leads to anterograde amnesia mimicking early Alzheimer's disease~     (AD) (so called HSA-nonAD). Recent studies showed that (a) the deficit of episodic memory as~     well as the level of hippocampal atrophy in bvFTD may be of similar severity to that observed~     in AD, even at initial presentation, leading to misdiagnosis in 22% of cases with post mortem~     diagnosis; (b) amnesia with HS due to microvascular lesion and microinfarcts can also cause~     impairment of episodic memory mimicking AD, without subcortical cognitive profile. Because~     these diseases involve distinct pathophysiological processes, they require different specific~     care and treatment. In consequence, it is very important to improve our knowledge about HS in~     order to identify its mechanism and improve the diagnosis.~   "
75645|NCT02576808|"~     Efficacy and adverse effects of Ginger extract in treating allergic rhinitis patients~     compared with Loratadine.The double blind randomized controlled trial study was approved by~     the Human Research Ethics Committee of Thammasat University NO.1.~   "
75646|NCT02576795|"~     This study is being conducted by Biomarin Pharmaceutical Inc. as an open label, dose~     escalation study in order to determine the safety and efficacy of BMN 270 (an~     Adenovirus-Associated Virus based gene therapy vector in participants with severe Haemophilia~     A.~   "
75647|NCT02576782|"~     In regional anesthesia local anaesthetics alone provide analgesia for not more than 4-8~     hours. Increasing the duration of local anaesthetic action is often desirable because it~     prolongs surgical anaesthesia and analgesia. Different additives have been used to prolong~     regional blockade. Vasoconstrictors can be used to constrict vessels, thereby reducing~     vascular absorption of the local anaesthetic. Additives like opioids, clonidine and verapamil~     were added to local anaesthetics, but the results are either inconclusive or associated with~     side effects. Steroids when used intrathecally are reported to cause arachnoiditis, but there~     is no evidence suggesting any neuritis when steroids are used in low concentration in~     peripheral nerve blocks.~      Steroids have powerful anti-inflammatory as well as analgesic properties. Perineural~     injection of steroids is reported to influence postoperative analgesia. They relieve pain by~     reducing inflammation, and blocking transmission of nociceptive C-fibres and by suppressing~     ectopic neural discharge. The addition of 5 mg of dexamethasone to 10 ml of 0.5%~     levobupivacaine in interscalene brachial plexus block showed improvement of postoperative~     analgesia for arthroscopic shoulder operation without any specific complications.~      The objective of this study is to compare the effects of combining of dexamethasone and~     bupivacaine versus bupivacaine alone in combined femoral and sciatic nerve block in patients~     undergoing lower limb vascular surgeries. The effects will be studied in terms of:~        -  Onset of sensory blockade and motor blockade~        -  Duration of analgesia / first request for analgesic~        -  Duration of motor blockade~   "
75648|NCT02576769|"~     Basal cell carcinoma (BCC) is the most frequent neoplasia worldwide. There are more than 30~     histopathologic subtypes, however the nodular subtype is the most common. Pigmented varieties~     are common in darker skin types, therefore in our country. Previous studies have shown an~     increase number and size of melanocytes. Melanogenesis were increased at the expense of~     hyperfunctioning melanocytes as well. The aim of the study was to describe the~     characteristics of melanocytes in pigmented and non-pigmented variants of basal cell~     carcinoma.~   "
75649|NCT02576756|"~     The investigator wants to investigate if there is an increased risk of postoperative~     pulmonary problems in patients who have had an intubation where there was need for more than~     a laryngoscope.~   "
75650|NCT02576743|"~     This study aims at investigating the blood hemodynamics with high spatiotemporal resolution~     in patients with brain aneurysms and AVMs as well as in healthy controls. Parameters such as~     peak blood velocity, wall shear stress and other derived parameters will be obtained from 4D~     flow MRI data acquired at ultra-high field strength (7 Tesla).~   "
75651|NCT02576730|"~     To include patient after traumatic (calcaneal) fractures for this study. They can be included~     to analyze gait with the OFM foot model, a non invasis model. Patient will be invited to the~     movement laboratory of the MUMC. Markers will be detached with dubble sided tape on~     anatomical points. After that gait will be recorded with infra-red camera's and an animation~     model will be formed. With this model further analysis can be made to range of motion between~     different segement of the foot. These results will be compared with patient with an~     arthrodesis, healthy subjects, futher questionnaires, physical examination and radiographic~     findings will be correlated.~   "
75652|NCT02576717|"~     The purpose of the trial is to determine the safety and efficacy of RPC1063 in patients with~     relapsing multiple sclerosis.~   "
75653|NCT02576704|"~     Myocardial perfusion imaging is an efficient tool to assess the risk of major cardiac events~     for patients with known or suspected coronary artery disease. If the test is normal, or if~     the abnormalities of perfusion represent less than 10% of the left ventricle myocardium, the~     patient is considered at low risk and should be managed with optimal medical treatment only.~      Recently, new gamma cameras using semi-conductor detectors have been developed. Their~     diagnostic performances have been demonstrated and confronted with various anatomical and~     functional reference techniques, such as coronary angiography and FFR. The prognostic value~     of a normal SPECT MPI has not been specifically assessed yet.~      Coronary microvascular dysfunction (CMVD) has been demonstrated to be an early marker of~     coronary artery disease (CAD). Preliminary data suggest that myocardial perfusion~     heterogeneity (a potential surrogate marker of endothelial dysfunction) can be assessed on~     conventional MP-SPECT, but its additive and independent prognostic value over the presence of~     myocardial ischemia remain unknown.~      Accordingly, the purpose of this study is :~        -  To assess the prognostic value of a normal myocardial perfusion stress imaging using a~          semiconductor gamma camera with a dual isotope high speed protocol,~        -  To evaluate the prognostic value of myocardial perfusion heterogeneity assessed by a new~          automatized image processing method, in normal SPECT MPIs.~      The main hypothesis is that the presence of myocardial perfusion heterogeneity is predictive~     of cardiovascular events in patients referred to the Nuclear Cardiology Department for~     routine evaluation of known or suspected CAD.~   "
75654|NCT02576691|"~     The purpose of this study is To assess percutaneous coronary intervention 's effect on short-~     and long- term outcomes, and complication incidence in resuscitated victims of cardiac arrest~     after acute myocardial infarction~   "
75655|NCT02576678|"~     This is a Phase 2, multicenter, open-label study in subjects with moderate to severe plaque~     psoriasis aged 6 to 17 years, inclusive, intended to assess the safety, tolerability, and PK~     of apremilast with 2 weeks of oral apremilast treatment followed by a 48-week extension of~     apremilast treatment. Moderate to severe plaque psoriasis is defined as Psoriasis Area~     Severity Index (PASI) ≥ 12, Body Surface Area (BSA) ≥ 10%, and static Physician Global~     Assessment (sPGA) of ≥ 3. The total study duration for each subject will last for up to a~     total of 107 weeks which includes screening, treatment (including the PK portion of the study~     and the extension treatment period), two short-term follow-up periods and a long-term~     follow-up period.~   "
75656|NCT02576665|"~     The purpose of this trial is to evaluate changes in immune activity relative to baseline~     following treatment with Toca 511 and Toca FC in patients with solid tumors (including~     recurrent high grade glioma [rHGG]) or lymphoma. This is a multicenter, open-label study of~     Toca 511 and Toca FC. Patients with advanced solid tumors or lymphoma, for whom curative~     options are not available, will be enrolled into the study, subject to all entry criteria.~     Tumors must be accessible to biopsy and/or resection. Patients will be qualified based on the~     presence of specific molecular characteristics, documented by Foundation Medicine (or~     equivalent) genomic profile report, and specific tumor types.~      Toca 511 will be administered by IV injection followed by (1) intratumoral injection~     following biopsy or (2) injection into the resection cavity wall following planned resection~     in the case of rHGG or brain metastases. Toca FC will be administered orally in cycles of~     therapy.~      Patients not undergoing resection of brain tumors will undergo 2 biopsies to allow assessment~     of baseline and follow-up immune activity in the tumor. Changes in immune activity in~     peripheral blood will be measured in all patients.~   "
75657|NCT02576652|"~     Bone Histomorphometry of the Proximal Femur in Denosumab-treated Subjects Undergoing Total~     Hip Replacement~   "
75658|NCT02576639|"~     The study determined the safety of CNP520 in healthy elderly over 3 months. Data relevant for~     Pharmacokinetic/Pharmacodynamic modeling were obtained in order to define the target dose in~     subsequent efficacy studies.~   "
75675|NCT02576418|"~     To calculate sensitivity (SN), specificity (SP), positive predictive value (PPV) and negative~     predictive value (NPV) of PartoSure TTD test in predicting delivery within 7 or 14 days from~     testing and to compare it with cervical length (CL) measurement by transvaginal ultrasound~     (15 mm cut-off)~   "
75715|NCT02575885|"~     This randomized pilot clinical trial studies nicotine delivery from novel non-tobacco~     electronic system (ENDS) in smokers. Studying the levels of nicotine delivered by various~     types and brands of ENDS to the bloodstream, and comparing this to the levels delivered from~     conventional cigarettes (the participant's own brand) may help provide information about the~     use of nicotine-containing products that may help inform/reform current tobacco policy,~     practice, and harm reduction approaches.~   "
75659|NCT02576626|"~     Rationale:~      Inhaled bronchodilators, beta-2-agonist or anticholinergic or combinations, can be delivered~     by several types of devices: dry powder (DPI), pressurized metered dose inhalers (pMDI), and~     wet nebulizers. Wet nebulization is available for short-acting bronchodilators only, is~     cumbersome, and, importantly, has never been scientifically been proven to be more~     efficacious than delivery by the other two methods. Yet many patients are happy with wet~     nebulization and in many clinics this administration method prevails. The investigators~     believe that combined long-acting bronchodilators, are more efficacious than combined short~     acting bronchodilators per nebulizers.~      Objective:~      To test the hypothesis that: The combination of the two long-acting bronchodilators~     indacaterol and glycopyrronium by dry powder inhalation confers a superior improvement~     compared to nebulisation with ipratropium/salbutamol, when administered as single dose in~     patients with stable state chronic obstructive pulmonary disease (COPD).~      Study design: Investigator initiated, randomised, active controlled, cross-over double-blind~     (and therefore double-dummy), study comparing the effects of single dose~     indacaterol/glycopyrronium 110/50 Breezhaler® versus single dose ipratropium/salbutamol~     nebulisation in patients with COPD in stable state Study population: Patients visiting the~     outpatient clinics or from general practitioner (GP) practices with COPD GOLD stage A-D, and~     (FEV1) post-bronchodilator FEV1/ forced vital capacity (FVC) < 70%; post-br FEV1 < 80%pred.~     Intervention The investigators will compare the effects of single dose~     indacaterol/glycopyrronium 110/50 Breezhaler® versus single dose ipratropium/salbutamol~     nebulisation in patients with COPD in stable state~      Main study parameters/endpoints:~      Area under the curve (AUC) from 0 to 6 hours of FEV1 with indacaterol and glycopyrronium,~     compared to nebulisation with ipratropium/salbutamol~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness:~      This study has no specific benefits for the participating patients. The study also has no~     major risks. Minor risks for participants after a single dosis can be throat irritation,~     cough, headache and dizziness, sinus tachycardia. The combination of treatments with~     β2-agonist bronchodilators and anticholinergic bronchodilators have been used in daily~     practice for many years in many countries and they are often prescribed both in COPD. Both~     indacaterol/glycopyrronium and ipratropium/salbutamol are approved for COPD treatment in the~     Netherlands~   "
75660|NCT02576613|"~     A randomized controlled, prospective, two-armed, mono-centric, assessor-blinded clinical~     trial will serve to generate preliminary data on the efficacy and safety of modified~     psychodynamic therapy (MPP-S) in stabilized patients after the first or subsequent episodes~     of schizophrenia or schizoaffective disorder.~   "
75661|NCT02576600|"~     The aim of this prospective randomized study was to evaluate the impact of peroperative~     pupillometry monitoring on per and post-operative opioid consumption in major gynecological~     surgery. All patients were anesthetized with TCI of propofol and remifentanil. In the~     intervention group, peroperative remifentanil target was guided by pupillometry. In the other~     group, remifentanil was administered according to standard practice.~   "
75662|NCT02576587|"~     The Elucidation of the Influence of Sleep Apnea on Risk of Atrial Fibrillation study.~      The study involves a case control design to investigate the extent to which there is an~     independent relationship of sleep disordered breathing (SDB) and paroxysmal atrial~     fibrillation (PAF). Cases will be defined as clinically identified patients with PAF and~     controls as those without AF. In order to rigorously address important biologic confounding~     influences, the cases and controls will be individually matched based upon age, gender, race,~     and body mass index. Those participants with both PAF and SDB (Apnea Hypopnea Index, AHI>=15)~     will be asked to return for a follow up exam after 3 months of SDB treatment in the Clinical~     Research Unit (CRU) for collection of the same measures collected at the baseline exam to~     observe for any significant changes with the purpose of collecting effect size data to inform~     future clinical trials.~      The total duration of the study is 4 years. The duration for any individual participant is up~     to from one to 13 weeks months, including a 3-month treatment period for those with moderate~     to severe SDB, i.e. AHI>15.~   "
75663|NCT02576574|"~     The purpose of this study is to demonstrate superiority with regard to Overall Survival (OS)~     or Progression Free Survival (PFS) of avelumab versus platinum-based doublet, based on an~     Independent Review Committee assessment, in Non-small cell lung cancer (NSCLC) subjects with~     Programmed death ligand 1+ (PD-L1+) tumors~   "
75664|NCT02576561|"~     The purpose of this research study is to test the safety and effectiveness of the~     investigational study vaccine, called TVGV-1. The study will test the vaccine in women with~     high grade HPV cervical infection.~   "
75665|NCT02576548|"~     This research study is designed to evaluate an experimental drug, MEDI4276, in treating~     breast and stomach (gastric) cancer.~   "
75666|NCT02576535|"~     Stereotactic radiosurgery is a well established treatment option for arteriovenous~     malformations (AVMs). The potential complications related to radiosurgery are well documented~     and are predominately related to radiation effects to the surrounding brain parenchyma. These~     risks increase with larger lesions, requiring a concommitant reduction in the amount of~     radiation that can be delivered. This reduction in radiation dose decreases the efficacy of~     treatment. The broad, long-term objectives of this proposal are 1) to determine the role of~     fractionated stereotactic radiosurgery in the treatment of large (>10cc) AVMs; 2) to evaluate~     the complication rates related to fractionating these doses compared to conventional~     stereotactic treatment 3) to evaluate the success rate of treating large AVMs with this~     protocol.~   "
75667|NCT02576522|"~     Investigators designed a study of a multimodality approach: surgery followed by~     hypofractionated intensity modulated radiation therapy (IMRT) using VMAT approach for~     patients with single, large brain metastases from solid primary tumor~   "
75668|NCT02576509|"~     The purpose of this study is to determine if nivolumab or sorafenib is more effective in the~     treatment of Advanced Hepatocellular Carcinoma.~   "
75669|NCT02576496|"~     This study evaluates the efficacy, safety and pharmacokinetics of EDO-S101 in patients with~     relapsed/refractory hematologic malignancies. All patients will receive EDO-S101.~   "
75670|NCT02576483|"~     The principle investigator is evaluating self-reported quality of vision and quality of life~     in physicians undergoing LASIK, SMILE and PRK surgery.~   "
75671|NCT02576470|"~     The overall goal is to exploit motor learning principles and adjuvant techniques in a novel~     way to enhance dysphagia rehabilitation. The proposed study will investigate the effects of~     three forms of biofeedback on training and determine whether adjuvant therapeutic techniques~     such as non-invasive neural stimulation and reward augment training outcomes has an effect of~     dysphagia rehabilitation. Outcomes from this research study may change the paradigm for~     treating swallowing and other internal functions such as speech and voice disorders.~   "
75672|NCT02576457|"~     The purpose of this study is to determine whether BMS-936559 is safe and has the desired~     pharmacologic activity in patients who have severe sepsis.~   "
75673|NCT02576444|"~     The primary objective of this phase II trial is to determine tumor overall response rate~     (ORR) in molecularly selected patients with measurable disease as assessed by the Response~     Evaluation Criteria in Solid Tumors (RECIST), before versus after 16 weeks of treatment~     across tumor types in each arm of the study.~   "
75674|NCT02576431|"~     Phase II, multi-center, open-label study of patients with advanced solid tumors harboring a~     fusion of NTRK1, NTRK2 or NTRK3.~   "
75676|NCT02576405|"~     It has been established that patients with psychiatric disorders tend to do worse in a~     surgical setting. Some types of surgery with greater impact than others, including orthopedic~     surgery. In our research group the investigators have shown this to be the case for hip and~     knee replacements within the mentioned patient category. However, the role of psychiatric~     disorder and use of different psychopharmacological drugs in relation to perioperative~     morbidity and mortality have not been thoroughly examined. The objective of this study is to~     shed light on the issue.~      Recent studies have shown that different types of psychiatric disorder influence surgical~     outcome differently. This emphasizes the need for specific knowledge regarding psychiatric~     diagnoses preoperatively. In this study around 2000 patients with or without psychiatric~     disorder of any kind will be studied preoperatively, which according to our previous study~     will include more than 200 patients receiving psychopharmacological treatment. The specifics~     that characterize every patient's psychiatric trades will be included in a validated~     questionnaire constructed for that purpose. The questionnaire is called SCL-92 and has been~     chosen in collaboration with Professor in Psychiatry, Rigshospitalet Anders Fink-Jensen.~     Preoperative information regarding their mental condition and medicine will be linked to~     surgical outcome in order to identify potential hazards in the perioperative period.~   "
75677|NCT02576392|"~     This randomized trial evaluates an intervention to minimize use of opioids following total~     hip and total knee replacement. Half the participants will receive an intervention (mailed~     educational materials, followed by a pharmacist call), and half will receive usual care.~   "
75678|NCT02576379|"~     Stroke is a leading cause of death and disability, and 15 million people suffer a stroke each~     year; one-third die and one-third are left permanently disabled. Because the risk of stroke~     increases with age, it has been considered a disease of the elderly, but stroke also occurs~     in middle-aged people.~      Thrombolysis with tissue plasminogen activator (tPA) is the preferred choice of reperfusion~     therapy of ischemic stroke if performed within 4.5 hours from symptom onset. Time to~     thrombolysis is associated with improved outcome: the sooner the treatment, the less risk of~     serious - and possibly permanent - damage to the brain. Unfortunately, only a small fraction~     of stroke patients make it to thrombolysis within the 4.5-hour; one explanation may be system~     delays including prolonged transportation.~      In May 2010, the first physician-staffed Helicopter Emergency Medical Service (HEMS) was~     implemented in the Eastern part of Denmark. An observational study evaluating the short-term~     effects of HEMS implementation compared patients transported by conventional ground ambulance~     (Ground Emergency Medical Service (GEMS)) to patients transported by HEMS. Patients~     transported by helicopter had increased time to specialized care. However, both 30-day and~     1-year mortality was slightly lower in patients transported by HEMS, although not~     significant, as was the degree of disability at three months measured by the modified Rankin~     Scale (mRS).~   "
75679|NCT02576366|"~     Single center, open label crossover study with 2 treatment phases in healthy volunteers.~      The potential of phenotypic drug probes to predict drug-drug interactions between tacrolimus,~     voriconazole and rifampin will be assessed.~   "
75680|NCT02576353|"~     The primary objective of this study is to determine the pharmacokinetic and pharmacodynamic~     relationship of a single dose of fentanyl sublingual spray in opioid naive subjects. The~     secondary objective is to determine the safety and tolerability of fentanyl sublingual spray~     in opioid naive subjects.~   "
75681|NCT02576340|"~     Upper gastrointestinal system endoscopy is widely used for diagnostic approach. To increase~     the tolerability and compliance of the patient, sedation is applied. There are many studies~     showing that sedation increases the patient compliance and the tolerability. However,~     spasmolytic use in GE has not been evaluated yet.~   "
75682|NCT02576327|"~     The purpose of this study is to evaluate the efficacy and safety of additional aprepitant to~     standard antiemetic regimen in Autologous Hematopoietic Stem Cell Transplantation.~   "
75683|NCT02576314|"~     The purpose of this study is to assess the safety, tolerability, and efficacy of Sofosbuvir~     containing regimens in treatment-naive or treatment-experienced patients with HCV genotype 3~     infection.~   "
75684|NCT02576301|"~     Phase 1 will investigate maximum tolerated dose of OXi4503 as a single agent and in~     combination with intermediate-dose cytarabine in subjects with relapsed/refractory AML or~     MDS.~      Phase 2 will investigate overall response rate of OXi4503 in combination with~     intermediate-dose cytarabine in 1) subjects with MDS after failure of 1 prior hypomethylating~     agent (Arm A) and 2) subjects with relapsed and refractory AML after treatment failure of up~     to 1 prior chemotherapy regimen (Arm B).~   "
75685|NCT02576288|"~     Abdominal obesity is a major risk factor for heart attack, stroke, peripheral vascular~     disease, dementia, cancer and Type 2 diabetes. The central hypothesis for this proposal is~     that pro-atherogenic mediators emanate from inflammation in deep subcutaneous adipose tissue~     (dSAT) that are released into the systemic circulation and damage the arterial vasculature.~     The investigators postulate that inflammation of dSAT, when quantified by macrophage~     phenotyping/enumeration will be a) closely linked with systemic levels of pro-atherogenic~     mediators and b) tightly associated with endothelial dysfunction and loss of central arterial~     elasticity, which are highly predictive of future cardiovascular disease (CVD) complications.~     These relationships provide the basis for macrophage-targeted therapy to reduce~     obesity-related inflammation and impaired arterial vasoreactivity. The investigators will~     evaluate a novel approach using a dipeptidyl peptidase 4 inhibitor (DPP4i) sitagliptin, which~     blocks signal transduction for monocyte/macrophage activation. Thus, in abdominally obese,~     18-40 years-old adults without clinical CVD, the show study is expected to show that~     sitagliptin versus placebo will:~        1. significantly improve early measures of arterial damage (brachial artery endothelial~          dysfunction and reduced carotid elasticity).~        2. significantly attenuate inflammation in dSAT and local production of pro-inflammatory~          mediators in adipose tissue, which will be associated with decreases in systemic~          pro-atherogenic mediators that contribute to atherogenesis.~      Since many obese persons fail to sustain weight loss by lifestyle interventions including~     diet and exercise, an important public health goal is to identify relatively safe alternative~     strategies that can be used pre-emptively in asymptomatic obese persons when arterial~     dysfunction and damage is still reversible before atherosclerosis progresses to serious CVD~     events.~   "
75686|NCT02576275|"~     This study will evaluate the efficacy and safety of duvelisib in combination with~     bendamustine and rituximab (DBR) vs placebo in combination with bendamustine and rituximab~     (PBR) in subjects with previously-treated indolent non-Hodgkin lymphoma (iNHL).~   "
75687|NCT02576262|"~     Papanicolaou (Pap) triage, with high specificity, has been recommended for primary Human~     papillomavirus (HPV) testing but is flawed by poor sensitivity and cytologist dependence. the~     investigators evaluated the potential role of HPV Integration detection in cervical~     exfoliated cells in HPV-positive women from a clinic-based population.~   "
75688|NCT02576249|"~     Corticosteroid injections are commonly used for the symptomatic treatment of knee~     osteoarthritis. Common practice is to inject the joint with a combination of corticosteroid~     and local anesthetic, with the rationale of providing longer duration pain relief with the~     corticosteroid and immediate, though short duration relief with the anesthetic. However,~     multiple in vitro and animal studies have shown that local anesthetic may be harmful to~     chondrocytes. Despite this data, use of intra-articular anesthetic remains widespread. Many~     clinicians believe incorporating the anesthetic is important because it can provide immediate~     pain relief and facilitate patient confidence in the treatment program. However, there is no~     published data to validate this reasoning. Therefore, the anesthetic has unknown clinical~     benefit and may have adverse effects on articular cartilage. In light of this, the~     investigators question the routine use of anesthetics in joint injections. The purpose of~     this study is to compare the effects of knee joint injections using: 1) corticosteroid with~     local anesthetic versus 2) corticosteroid with normal saline.~   "
75689|NCT02576236|"~     The H pylori infection remains a public health problem. The eradication rate with the first~     line triple therapy (PPI-amoxicillin-clarithromycin) is insufficient (estimated at 70%) due~     to the frequency of resistance to clarithromycin, which reaches 21% in France. Until~     now,European and French consensus recomended tofavor sequential therapy (5 days~     PPI-amoxicillin and 5 days PPI-clarithromycin-metronidazole) or quadruple bismuth therapy (~     10 days PPI-tetracyclin,-metronidazole- bismuth). Studies in countries with low prevalence of~     clarithromycin resistance reported eradication rate of 85% with sequential therapy and~     reported a low impact of clarithromycin resistance on the effectiveness of this treatment.~     However, recent studies suggest a greater impact of clarithromycin resistance. Recent~     meta-analysis shows that empiric sequential therapy is less efficacious than concomitant~     quadruple therapy. Therefore, recent Maastricht V / Florence meeting October 7-8 2015)~     recommended to abandon sequential therapy and to favor 14 days concomitant therapy in first~     line in order to reach an eradication rate >90%.~      In a multicenter randomized clinical trial (HELICOSTIC 2010-2011 AO ICST 2009), we compared a~     triple therapy guided by the results of a PCR test that detects resistance to clarithromycin~     and levofloxacin (HelicoDR ®) to empirical triple therapy (PPI-amoxicillin-clarithromycin).~     1384 patients and among them 526 infected patients were enrolled in 10 centers. The results~     in 415 patients were 73.1% for the empirical treatment versus 85.5% (p <0.001) for the~     treatment guided by PCR HelicoDR®. This study also demonstrated the limits of the test~     HelicoDR®: onerous, possibility of contamination, little practical contribution of the~     determination of resistance to quinolones.~      Moreover, it has been shown that triple therapy efficiency could be optimized by increasing~     duration up to 14 days and increasing dose of PPI to 40mg b.d;.and eradications rates > 90%~     were reported with susceptible to clarithromycin strains.~      Adverse events are less common with optimized triple therapy than with concomitant quadruple~     therapy.~      The main objective is to compare the efficacy of optimized triple therapy guided by the~     results of a PCR test (eradication rates 90% hypothesized) with quadruple concomitant therapy~     (eradication rate 90% hypothesized).~      The secondary objective is to determine side effects of optimized guided triple therapy as~     well as the quadruple concomitant therapy in France.~   "
75690|NCT02576223|"~     The purpose of this randomized study is to examine the effect of a selective suprascapular~     nerve block on post operative pain after arthroscopic shoulder surgery. Half of the subjects~     will receive a active nerve block with Ropivacain. Half of the subjects will receive a~     placebo nerve block with saline.~   "
75691|NCT02576197|"~     This study evaluates the efficiency of a probiotic as a coadjuvant in the conventional~     treatment of mild to moderate plaque psoriasis. Half of the patients will receive the~     probiotic per os, while the other half will receive a placebo; all patients will continue~     with their regular psoriasis treatment.~   "
75692|NCT02576184|"~     This study aim to assess long-term results of an incisional hernia-prophylactic mesh~     placement during stoma reversal after total mesorectal excision (TME) for rectal cancer~   "
75693|NCT02576171|"~     The primary objectives of this study is to test the feasibility and efficacy of group-therapy~     supported internet-delivered CBT for adolescents (13 - 17 years) with social anxiety~     disorder. Investigators will conduct an open trial with N = 30 participants. Participants~     will be assessed at baseline, immediately after treatment and at a 6-month follow-up.~   "
75694|NCT02576158|"~     The primary objective is to determine the sensitivity and specificity of the HPV~     Integration-based cervical screening for detection of high-grade cervical intraepithelial~     neoplasia (CIN), using colposcopic inspection as the reference method. Lesions will be~     confirmed as malignant or CIN by colposcopic inspection and histopathologic examination.~   "
75695|NCT02576145|"~     This study will assess whether daclizumab impairs the ability of children receiving a kidney~     transplant to elicit a primary immune response. The anticipated time on study treatment is 1~     day, and the target sample size is 82 individuals.~   "
75696|NCT02576132|"~     This study was part of a quality improvement project at the Department of Anesthesiology and~     Intensive Care Medicine, Charité - Universitaetsmedizin Berlin.~      Being in pain is reported to be one of the most important stressors in critically ill~     patients and worsens outcome. The evaluation of pain using validated scores in patients who~     are able to self-report significantly improves the quality of analgesic therapy and health~     related outcomes in intensive care patients.~      However, behavioral pain score that are used in sedated or delirious patients, often~     underestimate the severity of pain.~      The primary aim of this study is to investigate if measurement of the pupillary light reflex~     Amplitude correlates with the results of pain assessment using validated pain scores in~     critically ill patients.~   "
75697|NCT02576119|"~     The purpose of the study is to determine the effect of multiple doses of BMS-955176 on the QT~     interval corrected with Fridericia's method (QTcF) in healthy subjects.~   "
75698|NCT02576106|"~     The primary objective of this monocentric and feasibility study is to review the efficacy of~     cryotherapy in the treatment of unifocal mammary carcinomas in post-menopausal patients, with~     lumpectomy indication.~      The efficacy is defined by the rate of success of cryotherapy procedures. For each one of~     those evaluated process, an success will be defined on the tumor sample of lumpectomy by the~     absence of viable tumour cells.~      On the basis of our expertise, it seems interesting to propose this experimental procedure to~     patients as described above.~   "
75699|NCT02576093|"~     Purpose of the study is the local tolerability and systemic safety of a novel k-opioid~     receptor agonist proven to inhibit inflammation and pruritus in preclinical model of~     dermatitis.~      Three concentrations of WOL071-007 and placebo will be applied to patients with AD in a~     first-in-human, single-center, combined single/multiple ascending dose (SAD/MAD),~     double-blind, placebo-controlled, half-side comparison (MAD part only) study. The IMP will be~     applied occlusively to lesional or non-lesional skin. In the SAD part 24 subjects will~     receive the IMP for 2 days. In the MAD part, 30 hospitalized subjects will receive the IMP~     for 6 days. Study objectives are the safety and tolerability as well as (MAD part only) the~     pharmacokinetics and efficacy of WOL071-007.~   "
75700|NCT02576080|"~     Following the ACOSOG Z9001trial, imatinib received market authorization in Europe for~     patients with GIST at significant risk of relapse in the adjuvant setting, according to the~     classifications of Miettinen and Joensuu. Thereafter, the SSG XVIII / AI trial proved the~     need to revise the recommendations of the European Society for Medical Oncology regarding the~     optimal duration of treatment, which is currently three years. Patients at low risk of~     recurrence should not receive adjuvant treatment with imatinib and recommendations cannot be~     made from the literature data as to the indication of adjuvant treatment for patients with an~     intermediate risk of relapse. The provision of prognostic molecular markers in this group of~     so-called intermediate-risk subjects would facilitate the identification of responders to~     imatinib and avoid overtreating some patients and undertreating others who would benefit from~     Imatinib. Recently, Lagarde et al. have shown that the Genomic Index (GI = A ² / C, where A~     is the total number of alterations gains or losses and C is the number of chromosomes~     involved in these alterations in Comparative Genomic Hybridization array(CGH array)) could~     have prognostic value in GIST, particularly in intermediate risk GISTs. More recent work by~     the same author in 100 cases of GISTs with intermediate prognosis according to the~     classification of Miettinem identified two prognostic groups based on GI. The rate of~     metastatic relapse at 2 years was 30.6% in the group with GI greater than 10 versus 5.4% in~     the group with GI less than 10 (manuscript under preparation). Thus, it is legitimate to set~     up a randomized trial to study the effectiveness of adjuvant treatment with imatinib in the~     GIST population at intermediate risk of relapse and with a high GI. This study is a~     prospective randomized clinical trial: a phase III, open-label, 2 parallel groups,~     multicenter study. The primary objective of this study is to assess the efficacy of adjuvant~     Imatinib on rate of metastatic relapse at 2 years in patients with intermediate-risk~     gastrointestinal stromal tumor presenting a high Genomic Grade Index. The second objectives~     of this study are to compare the two therapeutic approaches in terms of metastasis-free~     survival at 1 year, 2 years and 3 years, overall survival, clinical and biological tolerance,~     safety and Quality of life of patients and caregivers. The eligible subjects must meet all of~     the following criteria : subject with a gastrointestinal stromal tumor, intermediary risk~     from the Armed Forces Institute of Pathology classification [Miettenen 2006], subject with~     Genomic Grade Index higher than 10 determined by CGH array, subject with surgery for primary~     tumor performed from 2 weeks to 2 months before starting adjuvant Imatinib mesylate, subject~     with no evidence of residual macroscopic disease after surgery and with a medical decision to~     prescribe imatinib. Subjects meeting any of the following criteria must not be enrolled :~     subject who have experienced spontaneous tumor rupture before surgery, subject whose tumor~     has a PDGFRA D842V mutation evidenced by sequencing from tumor Block and subject whose~     mutational status meets the wild phenotype definition as evidenced by sequencing from tumor~     Block.~      The Standard Group will receive adjuvant imatinib at a dose of 400 mg per day for a period of~     3 years. Patients will be assessed for metastases every three months for three years with~     thoraco-abdominal and pelvic CT scan. The Experimental Group will receive the same~     thoraco-abdominal and pelvic CT scan. The estimated proportion of subjects relapsing at 2~     years will be 30% in the experimental group and 2.5% in the standard group: alpha risk, 5%,~     power 80%. A total of 80 subjects (40 in each arm) will be included. This is a trial~     combining two learned societies that already are taking part in many clinical trials in~     France (French Sarcoma Group and French Digestive Cancer Federation). The expected benefits~     for patients are : not treat subjects for whom this treatment would offer too little benefit~     weighed against the disadvantages and treat subjects in whom this treatment would provide a~     real benefit and reduce the cost of treatment in patients who would not benefit from being~     treated by imatinib. The originality of this study is that it will include molecular data in~     the therapeutic decision and demonstrate the concept of individualized treatment in this~     patient population. This could ultimately change the current recommendations.~   "
77210|NCT02556385|"~     The aim of this study is to assess the safety and clinical efficacy of high or low-frequency~     repetitive transcranial magnetic stimulation based on brain activation with functional near~     infrared spectroscopy in poststroke nonfluent aphasia patients.~   "
75701|NCT02576067|"~     Vascular inflammation, a central feature of atherosclerosis, participates in the initiation,~     perpetuation and instability of plaques. Multiple clinical trials of cholesterol lowering~     therapy with statins have demonstrated that reductions in atherosclerotic cardiovascular~     disease (CVD) events are associated with reductions in both LDL cholesterol (LDL-C) and the~     systemic inflammatory mediator C-reactive protein (CRP). The Cardiovascular Inflammation~     Reduction Trial (CIRT) investigates if an anti-inflammatory agent commonly used in rheumatoid~     arthritis (low dose methotrexate (LDM)) can reduce CV morbidity and mortality among patients~     with a prior myocardial infarction or angiographically demonstrated multivessel coronary~     artery disease (GCO#13-1467).~      In this ancillary CIRT imaging study, the investigators propose to use this well validated~     approach by non-invasive serial FDG-PET/CT imaging in a subset of patients enrolled in the~     main CIRT trial to directly visualize vascular inflammation. Once the subjects are enrolled~     in the main CIRT trial, baseline imaging will be done and follow up imaging will be done~     approximately 8 months after the baseline imaging.~      18FDG-PET imaging data will be acquired, analyzed centrally and results incorporated into the~     main CIRT database. The investigators hypothesize that LDM treatment will result in a~     significant decrease in plaque inflammation as measured by 18-FDG-PET/CT after 8 months as~     compared to placebo.~   "
75702|NCT02576054|"~     This is a study of V501 [quadrivalent Human Papillomavirus (HPV) (Type 6, 11, 16 and 18) L1~     Virus-Like Particle (VLP) vaccine] in healthy Japanese boys. This study will consist of two~     periods. Period I of the study is to evaluate the immunogenicity and tolerability of V501 up~     to Month 7. Period II of the study is to evaluate the long-term immunogenicity and safety~     from Month 7 to Month 30. Two analyses are planned. The first analysis will be conducted when~     all subjects have completed their Month 7 visit or have been discontinued before that time.~     The second analysis will be conducted at the end of study. The primary hypothesis tested in~     this study is that seroconversion rates for the vaccine HPV types will be >90% at 4 weeks~     postdose 3.~   "
75703|NCT02576041|"~     The aim of the study is to evaluate the effects of Bilastine on patients' attention and~     reactivity levels by measuring psychophysical performance at a F1-high speed simulator~     driving test.~   "
75704|NCT02576028|"~     Post-surgical physiotherapy programs following to total hip arthroplasty (THA) show important~     differences between types and numbers of treatment sessions. Objectives are to investigate~     effectiveness of Fascial Manipulation when associated to a standard protocol of care.~   "
75705|NCT02576015|"~     The interaction of analgesia and sedation ot their effect on the prognosis of surgical~     patients still need to be elucidated.Currently, how to optimize intra-operative Analgesia and~     sedation to improve the prognosis of surgical patients is still a mystery.Intra-operative~     nerve block provided regional analgesia of the operated knee, which reduced the dosages of~     sedatives and analgesics.Based on a pilot study,the investigators found a decrease of~     post-operative adverse composite outcomes with the use of continuous femoral nerve block (2%~     versus 7%) ,therefore, the investigators postulate that general analgesia with lighter~     sedation in combination with peripheral nerve block could reduce the post-operative morbidity~     compared with deeper sedation.This randomized controlled trial is designed to test this~     hypothesis in patients receiving unilateral knee arthroplasty.~   "
75706|NCT02576002|"~     To describe the prevalence, incidence and current treatment and procedures patterns in a US~     pediatric population with PAH in MarketScan database during the period 2010-2013~   "
75707|NCT02575989|"~     The purpose of this study is to demonstrate that the specific management will increase the~     number of alive trauma patient arriving with a temperature > 35°C.~   "
75708|NCT02575976|"~     The purpose of this trial are to pragmatically investigate whether participation in a~     comprehensive CR (i.e., exercise with education) program in a Latin American MIC results in~     better functional capacity, cardiovascular risk factor control, health behavior,~     disease-related knowledge, depressive symptoms and lower mortality when compared exercise~     only CR or wait list control.~   "
75709|NCT02575963|"~     The study is a multicenter, open label Phase I/II trial.~        1. Establish the MTD of fractionated doses of Lintuzumab-Ac225 in combination with low dose~          cytosine arabinoside (Low Dose Ara-C, LDAC) (Phase 1 portion)~        2. Determine the response rate (CR + CRp + CRi) to fractionated doses of Lintuzumab-Ac225~          alone (Phase 2 portion)~   "
75710|NCT02575950|"~     An exploratory Phase 2, single, centre, prospective, randomized, placebo-controlled,~     double-blinded, split-face (left/right) design trial to evaluate the efficacy and~     tolerability of LEO 43204 in adults with moderate to severe acne.~   "
75711|NCT02575937|"~     The purpose of this study is to investigate the efficiency of nutrition education-based low~     glycemic diet intervention on community diabetic patients.~      Design: Randomized clinical trial.~      Main measures: HbA1c,fasting blood glucose(FBG),2 hours postprandial blood glucose（2hPG）~   "
75712|NCT02575924|"~     In this study the suitability of two -sequential and single step- commercially available~     culture media from the same brand was compared. The aim of such study is to verify whether is~     possible to improve the efficiency of infertility treatments in those couples who usually~     have a high cycle cancellation rate, such as poor responder patients and severe male~     infertility. The study population is composed of couples attending the fertility clinic: to~     this purpose all those couples approaching IVF treatments with a diagnosis of OAT,~     cryptozoospermia, advanced maternal age and women with a poor responder diagnosis were~     recruited. IVF treatments were randomly set to be cultured either with two-step sequential~     media or with one-step media to acquire data concerning the ongoing embryo culture~     development and clinical outcomes.~   "
75713|NCT02575911|"~     The purpose of this study is to evaluate the thickness accuracy of Laser-assisted in situ~     keratomileusis (LASIK) flaps created with the LenSx® Laser.~   "
75714|NCT02575898|"~     To assess the feasibility of a creative writing intervention in an advanced cancer~     population. Given it is a relatively simple intervention delivered by a non-clinician, the~     investigators are interested in better understanding its pattern of effect on patient~     psychological adjustment. The investigators aim to assess its feasibility in this study in~     order to inform a future larger study that will utilize a control arm.~   "
77407|NCT02553785|"~     This study is a multi-center, prospective, single-armed, study designed to evaluate the~     safety and efficacy of the BioVentrix Revivent TransCatheter (TC) System for left ventricular~     (LV) volume reduction in heart failure (HF).~   "
75716|NCT02575872|"~     This randomized clinical trial studies a physical activity behavioral intervention in obese~     endometrial cancer survivors. Learning about physical activity behavior while participating~     in a fitness class may help increase physical activity and improve the quality of life of~     obese endometrial cancer survivors.~   "
75717|NCT02575859|"~     The prognosis of peritoneal metastases from colorectal cancer has recently improved with~     cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC). Although~     outcomes are further improved when early stage peritoneal metastases are treated, adjuvant~     HIPEC has not yet been thoroughly addressed. This prospective pilot study assessed~     feasibility, safety and efficacy of HIPEC performed simultaneously with primary curative~     surgery in colorectal cancer patients with primary tumor-related risk-factors for the~     development of metachronous peritoneal metastases.~   "
75718|NCT02575846|"~     The purpose of this study is to determine which type of food results in a shorter hospital~     stay and better overall outcome for babies born with gastroschisis.~   "
75719|NCT02575833|"~     A phase 2a, multicenter, randomized, double-blind, placebo-controlled study in subjects with~     stable angina to evaluate the effect of AMG 334 compared to placebo on exercise time during~     an exercise treadmill test (ETT)~   "
75720|NCT02575820|"~     The investigators sought to examine the effects of 'old' red blood cells on mortality and~     morbidity of patients who undergoing revision hip replacement arthroplasty. The investigators~     hypothesis is that patients have an increased risk of mortality and infection after 'old' red~     blood cells transfusions compared with those who received 'new' transfusions.~   "
75721|NCT02575807|"~     This 2-part, Phase 1/2 study will test investigational cancer drugs known as CRS-207,~     epacadostat, and pembrolizumab. The purpose of this study is to find out how safe it is to~     give the investigational drugs to women with platinum-resistant ovarian, fallopian tube, or~     peritoneal cancer and if it helps patients with these types of cancer live longer or can help~     shrink or slow the growth of cancer.~   "
75722|NCT02575794|"~     This phase I trial studies the side effects and best dose of terameprocol in treating~     patients with high-grade glioma that has come back. Drugs used in chemotherapy, such as~     terameprocol, work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading.~   "
75723|NCT02575781|"~     Primary Objectives:~      To determine the maximum tolerated dose (MTD) of SAR428926 when administered as a single~     agent in patients with advanced solid tumors.~      To evaluate the anti-tumor response of SAR428926 when administered as a single agent in~     patients with advanced triple negative breast cancer (TNBC) positive for the protein targeted~     by SAR428926 To assess the preliminary anti-tumor response of SAR428926 when administered as~     a single agent in patients with advanced solid tumors positive for the protein targeted by~     SAR428926~      Secondary Objectives:~      To determine the overall safety profile of SAR428926 as a single agent. To characterize the~     pharmacokinetics (PK) profile of SAR428926 and its metabolites.~      To identify the recommended Phase 2 dose (RP2D) of SAR428926 as a single agent. To evaluate~     the immunogenicity of SAR428926. To assess the tumor response and duration of tumor response~     in all treated patients.~      To evaluate the benefit of primary prophylaxis on the occurrence of corneal~     (keratopathy/keratitis) toxicity (Expansion cohorts).~   "
75724|NCT02575768|"~     Exertional angina is common symptom in patients with severe aortic stenosis (AS) without~     obstructive coronary artery disease (CAD). Although reduced myocardial flow reserve is one of~     the proposed explanations for angina, little is known about the pathophysiology.~      This study aimed that adenosine-stress cardiac magnetic resonance can be used for the~     assessment of myocardial perfusion reserve and suggest the pathophysiology of development of~     angina in patients with severe AS without obstructive CAD.~   "
75725|NCT02575755|"~     Plasmodium falciparum parasitaemia in pregnancy is associated with maternal anaemia, low~     birth-weight and increased perinatal mortality. Whilst continuous prophylaxis is difficult to~     implement, intermittent presumptive treatment in pregnancy (IPTp) has proved to be practical~     and effective. In PNG, pregnant women currently receive IPTp using sulfadoxine-pyrimethamine,~     however, this therapy has the potential to be compromised by parasite resistance.~      The aim of the present trial is to assess the safety, tolerability, pharmacokinetics and~     efficacy of azithromycin (AZI) plus piperaquine (PQ) given as IPTp to pregnant Papua New~     Guinea women. The study will comprise of two sub-studies:~      (i) A safety, tolerability and pharmacokinetic study of AZI-PQ in pregnancy. (ii) A safety,~     tolerability and preliminary efficacy study of AZI-PQ in pregnancy.~   "
75726|NCT02575742|"~     The reason chronic constipation (CC) becomes commoner with age is not fully understood. New~     studies suggest that bowel contraction patterns, dietary fibre and gut bacteria are important~     and may differ in older people. Since CC reduces quality of life and is a major reason why~     elderly are admitted to hospitals and residential care, there is a need to understand how~     these factors change with age.~      Currently, placing a pressure sensing catheter inside the large intestine (pancolonic~     manometry) is the gold standard way to measure how well it contracts. However this involves a~     camera test (colonoscopy) which is invasive with risks of bowel perforations (~80/100,000).~     The risk is higher with age (64-80yr: ~90/100,000; 80+yrs: ~120/100,000), making it unethical~     for elderly.~      A technique called the 3D-Transit System has been developed, involving a small ingestible~     capsule, containing a 'trackable' electromagnet. By tracking movements of the capsule~     swallowed by participants, it provides precise detailed information on the capsule~     progression inside the whole gut and large bowel's contractile activity in real-time. It is~     minimally-invasive and radiation-free, making it possible to assess elderly for the first~     time.~      This study aims to assess how bowel contraction patterns, dietary fibre intake and gut~     bacteria differ between young and older adults (with and without CC), to better understand~     why CC is more common in elderly.~      It is a pilot, 4 arm, single centre, observational study involving 60 women aged 18-40 years~     and 70-90 years (15 non-constipated and 15 with CC for each age group). The study lasts 3~     weeks, containing 2 weeks of run-in period and 1 week of study period.~      The four groups participants will be asked to: swallow 2 capsules to assess their large~     bowel's contractile function using the 3D-transit system; provide stool samples to analyses~     their gut bacteria; and complete questionnaires to assess their gastrointestinal symptoms.~   "
75727|NCT02575729|"~     Purpose: To compare the outcome between sonography-guided steroid injection and direct~     steroid injection on carpal tunnel syndrome(CTS).~   "
75728|NCT02575716|"~     The objective of this study was to evaluate intubating condition using the McGrath® VL Series~     5, with and without muscle relaxant~   "
75757|NCT02575339|"~     This is an open label, multi-center, randomized phase I/II study of MLN0128 versus standard~     sorafenib. Eligible subjects in the phase I trial will receive MLN0128 in escalating doses.~     Eligible subjects in the phase II trial will be 1:1 randomized to either the MLN0128 arm or~     the sorafenib arm.~   "
75729|NCT02575703|"~     This type of study is called a radiolabeled study. For this study, LY3023414 has been~     specially prepared to contain the radioactive carbon atom [¹⁴C]. [¹⁴C] is a naturally~     occurring radioactive form of the element carbon. Adding a low dose of radiation to the study~     drug does not change how the drug works but helps to identify when the drug appears in the~     blood, urine, breath, and stool after it is given. The study will last about 15 days for each~     participant, not including screening. Screening is required within 28 days prior to~     enrollment. This study is for research purposes only and is not intended to treat any medical~     condition.~   "
75730|NCT02575690|"~     Potential protective cardiovascular effect of Spirulina maxima supplementation was studied in~     a double-blind placebo-controlled trial of obese subjects with treated hypertension, each~     randomized to receive spirulina or a placebo.~   "
75731|NCT02575677|"~     Oxycodone is used to treat early labour pain instead of meperidine. However, the efficacy and~     effects of oxycodone to the newborn has not been studied. In the present study, patient who~     has received oxycodone is asked about pain relief and after labour single venous blood sample~     from the parturient and umbilical cord are taken for the analysis of oxycodone.~   "
75732|NCT02575664|"~     Buprenorphine is a highly lipophilic thebaine derivative that appears to have high affinity~     for mu-, kappa-, and delta-opioid receptors and low affinity for opioid receptors like 1~     -receptors. It acts as a partial agonist at the mu-opioid and as a partial agonist/antagonist~     at the kappa-opioid, and as an antagonist at the delta opioid receptors. Buprenorphine has up~     to two-fold duration of action and it is approximately 30-fold more potent when compared to~     morphine.~      Pain is a common problem in patients coming to joint arthroplastic surgery. Buprenorphine low~     dose patches are recommended for treatment of moderate pain for example osteoarthritis pain.~     It is known that well treated pain even preoperatively may prevent prolonged postsurgical~     pain.~      In the present study the effects of low dose buprenorphine on postoperative pain and recovery~     were assessed.~   "
75733|NCT02575651|"~     Fluzoparib is an oral potent, selective PARP-1 and PARP-2 inhibitor. The objective of this~     study will be to investigate the safety and tolerability of Fluzoparib Capsule when given~     orally to Chinese patients with advanced solid malignancies. In addition, the pharmacokinetic~     profile, MTD (if possible) and efficacy of Fluzoparib will be investigated.~   "
75734|NCT02575638|"~     This is a single-arm, non-randomized feasibility and Phase I trial of 20(S) Camptothecin~     Propionate administered orally. CZ48 will be administered in successive cohorts of 1 patient~     per participating site until hints of toxicity (grade 2 or worse adverse events related to~     the drug) are observed. Then cohorts of 3+3 patients will be treated. CZ48 will be~     administered orally daily (1 course = 4 weeks). No pre-medications will be administered.~     Patients will be asked to drink up to one gallon of fluid daily if possible to flush the~     bladder to mitigate cystitis. Cystitis is an anticipated toxicity as CZ48 is a pro-drug of~     CPT (Camptothecin)~   "
75735|NCT02575625|"~     Hypothesis of this study is the existence of a relation between parameters measured by~     FibroScan® FS 502 according to our non invasive method and liver steatosis condition.~      This proof of concept validation is made up of two steps:~        -  Step 1: feasibility study of the method on 10 healthy volunteers~        -  Step 2: diagnosis study on 50 healthy volunteers (25 between 18-30 years-old and 25~          between 40-65 years-old) and on 25 patients whom cares including an liver biopsy et whom~          the histological answer is clean steatosis (NAFLD).~      Experimental procedures consist in:~        -  Fibroscan measure, preceded by tracking ultrasonography.~        -  liver MRI (for substudy about MRI comparison, in step 2)~        -  a blood test for biological assessment of liver functions~   "
75736|NCT02575612|"~     The study aims to evaluate the ability of representative vacuum-assisted minimal invasive~     biopsy (VAB) to diagnose pathological complete response (pCR=ypT0) in breast cancer patients~     after neoadjuvant chemotherapy (NACT).~   "
75737|NCT02575599|"~     The overall aim of this study is to assess the effectiveness of a web-based Guided~     Self-Determination program among adults with type 2 diabetes in general practice in order to~     improve diabetes self-management behaviours and HbA1c through enhanced patient activation,~     self-care competence, and autonomy.~   "
75738|NCT02575586|"~     The main objective of this study is to analyze the effect of dry needling of the soleus~     muscle to modulate muscle tone in healthy non-injured subjects. The secondary objective is to~     study if effects occur due to changes in the neural or mechanical component (or both).~      Hypothesis: Deep Dry Needling of the latent medial Myofascial Trigger Point (MTrP) of the~     soleus muscle produces changes in muscle tone varying the passive resistance torque at a rate~     of 180º/ s.~   "
75739|NCT02575573|"~     The investigators will retrospectively examine the connection between resuscitation decisions~     of admitted patients at the ED of the University Hospital of Basel and several demographic~     and health related measures. Additionally there will be an examination, which patient~     characterestics may have lead to patients not having been asked about resuscitation~     decisions.~   "
75740|NCT02575560|"~     EGFR-TKI is the main is the first line therapy for local advanced or metastatic non-small~     cell lung cancer with EGFR gene mutation. The median progression free survival time is around~     11 months with the first generation EGFR-TKI. Patients with acquired resistance with first~     generation EGFR-TKI usually with EGFR exon 20 mutation (T790M). Change the drug~     administration maybe prolong patients PFS and evently prolong OS.~   "
75741|NCT02575547|"~     This is an prospective，open-label, none-interventional, observational， multicenter phase II~     clinical trial. The purpose of this study is to observe the effect of neoadjuvant~     chemotherapy followed by concurrent chemoradiation therapy(CCRT) on nutritional status in~     locoregionally advanced nasopharyngeal carcinoma(NPC) patients, analyse the changes of~     patients' nutrition status during the treatment and the connection between nutrition changes~     and curative effects, evaluate nutritional risks under the neoadjuvant chemotherapy and CCRT~     and provide data and basis for further study。~   "
75742|NCT02575534|"~     The aim of this study is to determine if anti-arrhythmic drugs with a sodium channel-blocking~     mechanism exert a detrimental electromechanical effect on cardiac function in patients~     depending upon baseline intraventricular conduction and left ventricular function.~   "
75775|NCT02575105|"~     We tested the hypothesis that BIS values are altered in pediatric patients with hydrocephaly.~     We also tested the hypothesis that BIS values are altered in adult post cerebral hemorrhage~     patients with hydrocephaly undergoing ventricular-peritoneal shunt placement~   "
75743|NCT02575521|"~     Despite theoretical benefits of intravenous agents, volatile agents remain popular. In a~     study comparing desflurane, isoflurane, and sevoflurane in a porcine model of intracranial~     hypertension, at equipotent doses and normocapnia, cerebral blood flow (CBF) and~     intra-cranial pressure (ICP) were least with sevoflurane.~      Propofol is the most commonly used intravenous anesthetic. It has many theoretical advantages~     by reducing cerebral blood volume (CBV) and ICP and preserving both autoregulation and~     vascular reactivity. Neurosurgical patients anaesthetized with propofol were found to have~     lower ICP and higher CPP than those anaesthetized with isoflurane or sevoflurane.~      The well known pharmacodynamic advantages of intravenous anesthetics may give this group of~     drugs superior cerebral effects when compared with inhalation anesthetics.~   "
75744|NCT02575508|"~     This phase Ib/II trial studies the side effects and best dose of pan fibroblast growth factor~     receptor (FGFR) kinase inhibitor BGJ398 when given together with fluorouracil, irinotecan~     hydrochloride and oxaliplatin (combination chemotherapy) in treating patients with untreated~     pancreatic cancer that has spread to another place in the body. Pan FGFR kinase inhibitor~     BGJ398 may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Drugs used in chemotherapy, such as fluorouracil, irinotecan hydrochloride and~     oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Giving pan FGFR~     kinase inhibitor BGJ398 together with fluorouracil, irinotecan hydrochloride and oxaliplatin~     may be a better treatment for pancreatic cancer.~   "
75745|NCT02575495|"~     The major hypothesis to be tested is that there was no difference in the clinical outcome~     between 7(short-course) and 14(traditional-course) days of antibiotic treatment for~     asymptomatic bacteriuria early after kidney transplantation.~   "
75746|NCT02575482|"~     The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of~     SUVN-D4010 in healthy male subjects following single or multiple ascending doses.~   "
75747|NCT02575469|"~     Exercise capacity is a key factor to evaluate and treat patients in different diseases (e.g.~     ischemic heart disease, chronic obstructive pulmonary disease, cystic fibrosis). The best way~     to measure exercise capacity is to perform a cardiopulmonary exercise testing.~     Normal/reference values in health and disease relate to specific population and~     subpopulations. The population in Israel is unique in its diversity.~      Objectives: Data collection of exercise capacity assessment in health and illness in the~     northern of Israel for future local database.~      Population: 500 Patients evaluated routinely in the exercise lab (pediatric cardiology~     institute) and healthy volunteers evaluated as controls.~      Study design: Prospective observational study. Participants will answer a health related~     questioner, undergo a physical examination, perform a cardiopulmonary exercise test on a~     treadmill or a cycle ergometer.~   "
75748|NCT02575456|"~     A Single-Center, Randomized, Blind, Phase II Clinical Trial to Evaluate the Safety and~     Immunogenicity of the Adenovirus Type 5 Vector Based Ebola Virus Disease Vaccine (Ad5-EBOV)~     in Healthy Adults Aged Between 18 and 50 years in Sierra Leone.~   "
75749|NCT02575443|"~     The purpose of this study is to evaluated whether the depth of neuromuscular block may affect~     the unicon value of anesthetic depth monitoring system (ADMS).~   "
75750|NCT02575430|"~     To evaluate the natural history of visual function in subjects with IRD phenotypically~     diagnosed as Leber congenital amaurosis (LCA) or retinitis pigmentosa (RP) caused by RPE65 or~     LRAT gene mutations.~   "
75751|NCT02575417|"~     This study will determine the feasibility of using an end-of-life conversation game (called~     My Gift of Grace) as a community engagement activity series to help caregivers, patients~     with chronic illness, and/or their families perform advance care planning.~   "
75752|NCT02575404|"~     This study is a dose escalation of GR-MD-02 with the standard therapeutic dose of~     pembrolizumab in patients with advanced melanoma, non-small cell lung cancer, and head and~     neck squamous cell cancer.~   "
75753|NCT02575391|"~     This study will evaluate whether a Whole Food Intervention reduces the frequency or severity~     of esophagitis in patients receiving treatment for non-small cell lung cancer.~      The Whole Food Intervention consists of yogurt, butter, honey, vanilla, and glutamine with 3~     portioning cups, equal to approximately 12 ounces, taken daily before starting radiation~     therapy.~   "
75754|NCT02575378|"~     The optimum regimen of maintenance treatment after first-line chemotherapy in patients with~     metastatic colorectal cancer （mCRC） is unknown. This study was designed to determine the~     efficacy and safety of maintenance treatment with capecitabine metronomic chemotherapy plus~     Chinese Traditional Medicine.~      In this Prospective, open-label, randomised controlled trial, the investigators will recruit~     159 mCRC patients who have finished 18 to 24 weeks first-line chemotherapy and disease~     evaluation is SD, PR or CR. The patients will then accept Chinese traditional diagnosis and~     be randomised into two group, capecitabine metronomic chemotherapy only as control group and~     the metronomic chemotherapy plus Chinese Traditional Medicine as experimental group. This~     treatment regimen will be continued until progression, death, or an unacceptable adverse~     event.~      The primary endpoint is progression-free survival (PFS). Secondary endpoints are overall~     survival (OS), quality of life (QOL) and toxic effects.~   "
75755|NCT02575365|"~     This is a 24-month, open-label, multicenter study with a single treatment arm design.~      Primary objective of this study is:~      -To investigate the effects of Fingolimod on cognitive performance in highly active relapsing~     remitting multiple sclerosis patients~      Secondary objectives of this study are:~        -  To investigate the correlation between the effect of fingolimod on cognitive~          performances and MRI data.~        -  To evaluate the effect of fingolimod on biomarkers (24 hydroxy cholesterol, osteopontin~          and matrix metalloproteinases) related to neurodegeneration~        -  To investigate the effect of fingolimod on brain gray matter atrophy and thalamic~          atrophy.~      Polulation We will recruit a minimum of 80 relapsing remitting MS (RRMS) patients according~     to the McDonald criteria.~   "
75756|NCT02575352|"~     CPC REGISTRY is a multi-center, international, prospective, open-label, observational study~     on the use of injectable calcium phosphate cements for the treatment of bone defects in~     adults. All patients will be treated with any of the two injectable calcium phosphate bone~     substitutes (GRAFTYS®HBS/GRAFTYS®Quickset or their private labels) according to standard~     clinical practice and according to the information provided by GRAFTYS manufacturer in~     respective device Instructions For Use (IFU).~   "
75758|NCT02575326|"~     Little guidance is given to physicians caring for obese adolescents with asthma, however,~     findings suggest that interventions designed to achieve asthma control in these patients are~     necessary. Because of the psychosocial factors often associated with obesity and asthma~     (e.g., low self-esteem, depression, and low quality of life) successful interventions should~     incorporate a patient-centered approach. The proposed study design is a clinic-based,~     randomized controlled trial (RCT) in teens with a history of asthma and who are overweight or~     obese.~   "
75759|NCT02575313|"~     This is a study to see if a Whole Food Intervention (WFI) consisting of yogurt, butter,~     honey, vanilla, and glutamine will lower the frequency or severity of mucositis in head and~     neck cancer patients undergoing standard treatment.~   "
75760|NCT02575300|"~     This is a prospective phase II open-label trial, stratifying patients equally into two~     cohorts consisting of carcinoid tumors and pancreatic neuroendocrine tumors (pNETs). The~     purpose of this study is to test any good and bad effects of the study drug called Ibrutinib.~      The study population will consist of adult patients with histologically confirmed low to~     intermediate grade NETs of the GI tract, lungs and unknown primary (carcinoid tumors) or~     pNETs. All patients must be confirmed to have advanced disease. The study will enroll up to~     51 patients in two cohorts (30 carcinoid and 21 pNET patients).~   "
75761|NCT02575287|"~     White light endoscopy remains the gold standard technique to evaluate gastrointestinal tract.~     Gastroesophageal Reflux Disease (GERD) is defined as presence of reflux symptoms (heartburn~     and regurgitation) associated or not with lesions in esophageal mucosa. Based on findings at~     videoendoscopy GERD patients can have a complicated reflux disease (erosive esophagitis) or~     not and be considered as a non erosive reflux disease (NERD). 60% of GERD patients have~     normal endoscopy (NERD) and requires further studies to achieve a definitive diagnosis. Based~     on this fact is that the study will be focus on NERD patients.~      Recently an image-enhanced endoscopic technology using a pre-processor band-limited light~     called Optical Enhancement system (OE system™), was developed (Pentax Medical). This new~     technology combines digital signal processing with optical filters that limit the spectral~     characteristics of the illumination light. The new innovated optical filters achieve higher~     overall transmittance by connecting the peaks of the hemoglobin absorption spectrum (415 nm,~     540 nm and 570 nm) creating a continuous wavelength spectrum. There are two modes with~     different OE filters (Mode 1 and Mode 2). Mode 1 is designed to improve visualization of~     microvessels with a sufficient amount of light, and Mode 2 is designed to improve contrast of~     white-light observation by bringing the color tone of the overall image closer to that of~     natural color.~      In addition, new scopes has been developed which combines high definition images with optical~     magnification called Magniview™. These scopes increase the image up to 136 times with a~     better quality of image than standard scopes without optical zoom. Sharma et al. evaluated~     esophageal changes in NERD patients using a similar pre-processor filter called Narrow Band~     Imaging (NBI). They found that a significantly higher proportion of patients with NERD had an~     increased number, dilation and tortuosity of the microscopic intrapapillary capillary loops~     (IPCLs), and were considered the best predictors for diagnosing NERD. They used optical~     chromoendoscopy technology (NBI) associated to magnification scopes (Olympus GIF Q240Z,~     115x), but they did not evaluated if the contribution with this technology to the~     observations found in GERD patients were as a result of the NBI or the magnification scopes.~     The investigators opinion is that chromoendoscopy is useful but is the magnification what~     makes up the difference.~   "
75762|NCT02575274|"~     The purpose of this experimental study in humans is to evaluate and compare, the regenerative~     therapy for the treatment of peri-implantitis using different bone substitutes and absorbable~     membranes with surgical therapy without the use of materials for regeneration.~   "
75763|NCT02575261|"~     The purpose of this study is to evaluate the safety and effectiveness of CAR-T cell~     immunotherapy in treating with EphA2 positive malignant glioma patients.~   "
75764|NCT02575248|"~     This study aims at investigating the fertility outcome of endometriosis suppression with~     dienogest 2mg / day for 3 month followed by induction of ovulation for 3 month in~     endometriosis patients stage I and II.~   "
75765|NCT02575235|"~     This study is to assess the impact on the prevention of sarcopenia after taking~     cetylpyridinium chloride targeting the patients of pre-sarcopenia or sarcopenia over the age~     of 60~   "
75766|NCT02575222|"~     This study will evaluate the use of nivolumab before surgery in patients with high-risk clear~     cell renal cell carcinoma who are eligible for nephrectomy. Nivolumab is an antibody that may~     help activate the immune system by blocking the function of an inhibitory molecule, PD-1.~   "
75767|NCT02575209|"~     Individuals with schizophrenia have important and persistent deficits in multiple~     neurocognitive domains as well as in the Social Cognition (SC). SC refers to the mental~     operations underlying social behavior, and it is understood as a multidimensional construct~     that comprises emotional processing (EP), social perspective and knowledge, attributional~     bias and theory of mind (ToM) or mentalizing. Mentalizing and EP skills have been the two~     most studied subdomains of SC in schizophrenia. Both domains have been found to be impaired~     in chronic schizophrenia patients as well as in patients in early stages of the illness. In~     this context, although negative symptoms may play and important role, females seem to perform~     better than males in ToM and EP tasks, suggesting the presence of gender differences in the~     SC skills in patients with schizophrenia. However, to our knowledge, there are no studies~     that have explored the gender-related differences between cognitive and affective ToM and its~     relationship with the EP performance in schizophrenia patients of recent diagnosis comparing~     with healthy subjects.~      In this line, the main objective of this project is to analyze the influence of gender in the~     cognitive and affective ToM abilities, in a group of patients with schizophrenia in early~     stages of the illness comparing with healthy subjects. Secondarily, this study pretends to~     explore the association between EP skills and affective ToM tasks performance in males and~     females with and without recent diagnosis of schizophrenia.~   "
75787|NCT02574949|"~     The investigators sought to investigate the efficacy of low frame rate (fluoroscopy at 7.5~     frames per second (FPS) and Cine at 10 pulse per second (PPS) vs. conventional (15 FPS and 15~     PPS) on radiation dose to the patient and the operator during coronary angiography and~     intervention. In addition, investigators sought to qualitatively assess the effect, if any,~     of the low frame rate on angiographic image quality.~   "
75788|NCT02574936|"~     The purpose of this study is to reduce the volume of dead space by a modification in kardakis~     flap procedure and consequently, to reduce the use of drains, wound drainage, seroma and~     hematoma formation, skin degradation and recurrence rates.~   "
75789|NCT02574923|"~     The aim of this study is to assess the safety and effectiveness of autologous bone marrow~     mononuclear stem cells in patients with cerebral palsy.~   "
75826|NCT02574442|"~     The goal of this proposal is to determine whether a hand-held confocal microscopy probe may~     perform better than standard methods in detecting cancer or pre-cancerous abnormalities of~     the cervix. The confocal probe will provide invivo histopathology-like images of cell~     morphology and three-dimensional tissue architecture non-invasively in real time.~   "
75768|NCT02575196|"~     Cardiac Arrest is among the leading causes of death, with survival still well under 50% and~     the majority of the survivors suffering from moderate to severe neurologic deficits. The~     human, social and economic costs are staggering.~      During resuscitation, damage is mitigated if chest compressions and other medical care are~     optimal, allowing some blood to reach the brain and some oxygen to reach the cells. Once the~     heart starts beating again, which is called return of spontaneous circulation, brain~     perfusion is reestablished, but usually not to normal. The now damaged brain is very fragile,~     can be sensitive to any changes in blood pressure or metabolic abnormalities, and swelling~     might set in. Hypoperfusion can persist, without the clinician's knowledge. All of these~     events further damage the brain and diminish the odds that the patient will regain a normal~     life. Therefore, the hours following return to spontaneous circulation are critical to the~     patient's future recovery, and constitute a window of opportunity to maximize the brain~     ability to heal.~      In order to optimize resuscitative efforts and post-arrest management, clinicians must know~     what is actually happening with the most vital organ, the brain. The problem is that it is~     very difficult to do in a comatose patient. The available technologies only reveal indirect~     evidence of brain suffering, like the swelling on CT-scans, but not to continuously evaluate~     at the bedside if the brain actually receives enough blood.~      The FDA recently approved a device named the c-flow, made by ORNIM. This device looks at red~     blood cells in the brain and the speed at which they move to evaluate an index of cerebral~     perfusion. It does so with sensors put on the patient's forehead, which emit and detect~     ultrasounds and infrared light. This index can inform the clinician about the amount of blood~     flow the brain receives, and it can be put in place very quickly, even during resuscitative~     efforts, and without any danger for the patient.~      The study looks at how well the information obtained with the c-flow matches the one obtained~     from other indirect indices and, more importantly, how well it predicts patient outcome. The~     investigators wish to establish threshold values of this index of perfusion that predict a~     good recovery so that this information may be used to optimize patient's neurological outcome~     in the near future.~   "
75769|NCT02575183|"~     The lack of proven waterpipe smoking cessation interventions makes it important to explore~     interventions proven effective for cigarette smoking cessation. The investigators hypothesize~     that Varenicline (Chantix) administrated for 12 weeks is associated with higher sustained~     quit rate at 12 weeks compared to placebo. The investigators propose to conduct a randomized~     double-blind placebo-controlled trial that will evaluate the effect of Varenicline (Chantix),~     in two parallel groups each consisting of 76 habitual waterpipe smokers who are willing to~     quit. Potential participants will be approached in cafés, word-of-mouth and through media and~     will be invited to the American University of Beirut Medical Center to complete study~     procedures. Both study groups will receive the same behavioural intervention in combination~     with either Varenicline (Chantix), an FDA approved drug indicated for use as an aid to~     smoking cessation treatment, or placebo. Participants will complete study procedures in four~     visits. During visit-1 the informed consent process, baseline assessments and randomization~     will be completed and Varenicline (Chantix) or Placebo will be initiated together with the~     behavioural interventions. The behavioural intervention will be continued over the next 2~     visits. An end of treatment visit 12 weeks after quit date will be dedicated to assessing~     sustained quit rate and other outcomes.~   "
75770|NCT02575170|"~     Introduction: Intravenous infusion of amino acids during cesarean delivery in mothers and~     neonates improves neonatal growth. Amino acid before and during anesthesia also prevents~     hypothermia and associated untoward effects.~      Method: After ethical approval, this prospective randomized double blind controlled study is~     being conducted in the university hospital of BPKIHS. Seventy six parturients (ASA 1 & 2)~     undergoing cesarean delivery without fetal distress, intrauterine growth retardation,~     congenital malformation or premature labor will be enrolled.~      For a period starting from approximately one hour prior to spinal anesthesia, Group 1 and~     Group 2 patients will receive 200 ml of amino acid and lactated ringers solution respectively~     at 2 ml/kg/hr. The ambient operating room temperature will be maintained near 23º C. No~     heating methods will be applied apart from covering with a blanket.~      Primary outcome measure will be neonatal rectal temperature at 0, 5 and 10 min after birth.~     Secondary outcome measures will be APGAR scores and suckling reflex in the newborn, change in~     rectal temperature relative to baseline and discomfort related to cold sensation in the~     mother and the occurrence of shivering and duration of hospital stay both in the mother and~     newborn.~   "
75771|NCT02575157|"~     Bisphosphonates (BP) are widely used in the prevention and treatment of osteoporosis in~     postmenopausal women and older men. Recently, there has been concern about the risk of~     adverse events after several years of using these agents. This has resulted in a publication~     from the Food and Drug Administration that suggested that, for many individuals, a holiday~     from bisphosphonates might be considered after 4-5 years of continuous use. In that~     publication there was little, if any, guidance on how clinicians should proceed after the~     holiday is initiated.~   "
75772|NCT02575144|"~     This phase III study, open-label, randomized study investigating lenalidomide and~     dexamethasone with and without biaxin in subjects with newly diagnosed, previously untreated~     MM. Eligible subjects will be randomized in a 1:1 ratio to receive a regimen consisting of~     either biaxin, lenalidomide, and low-dose dexamethasone (BiRd arm), or lenalidomide and~     low-dose dexamethasone (Rd arm). 306 patients will be included (50% in Spain (153) and 50% in~     the USA (153)~   "
75773|NCT02575131|"~     Rationale: The worldwide prevalence of obesity increases rapidly, and at the moment there are~     more overweight than underweight people in the world. This is partly caused by increased~     energy, or food intake. One of the physiological factors regulating the food intake pattern~     is satiety. Though the regulation of food intake has been studied quite extensively, the~     underlying mechanisms are not well elucidated yet and still new factors involved in this~     regulation are being found. Therefore, in this study the investigators aim to develop an in~     vitro screening tool combined with an in silico model for prediction of satiety, for cost-~     and time - effective screening of satiating properties of new and existing complex food~     products and (functional) ingredients, based on actual satiety scores measured. A second aim~     of the Wholegrain Satiety project is to evaluate satiating properties of different types of~     wholegrain breads and other oat based products, both for validation purposes and to~     strengthen the scientific evidence for health benefits of wholegrain products. As part of~     this study, acute satiety scores after consumption of various breakfast products in~     well-controlled clinical conditions will be compared with satiety scores obtained in 'at~     home' test conditions.~      Objective: The current study aims to compare the acute satiety effect of carbohydrate~     breakfast products.~   "
75774|NCT02575118|"~     It has been reported that therapy with polymer-based dental filling materials was associated~     with higher concentrations of bisphenol A in saliva and urine directly after the treatment.~     The objective of the present project is to gain knowledge about the concentration of~     bisphenol A in saliva and urine before and after treatment with polymer-based dental filling~     materials, using sensitive analytical methods.~   "
75776|NCT02575092|"~     Contrast-induced nephropathy has become the third-largest cause of hospital acquired acute~     renal injury, and which morbidity is only less than that of renal hypoperfusion and renal~     toxicity of drugs, about 11%of all cases. Pathophysiologic mechanisms of contrast-induced~     nephropathy(CIN) is not entirely clear yet. May be associated with renal hemodynamic changes,~     medullary ischemia because of renal blood flow reduction, oxidative stress, endothelial~     dysfunction ,contrast agents damage the epithelium of renal tubular directly and so on.~     Currently the studies have proved that inflammation(CRP, TNF-α and NF-қB) played a role in~     CIN.It is well-know that the hyperhomocysteinemia(HHCY) is a independent risk factor for~     cardiovascular diseases, which has pro-inflammatory effects. Researches showed that Hcy~     stimulated CRP generation by the NMDAr-ROS-ERK1 / 2 / p38-NF-қB signaling pathway and~     triggered inflammatory response. We will compare the CIN incidence of different plasma Hcy~     levels in adults hypertensive patients undergoing coronary artery diagnosis and treatment(CAG~     and PCI). CIN was defined as an absolute ≥0.5mg/dl or a relative ≥25% increase in the serum~     creatinine level at 48 hours after the procedure. The relationship between decreased plasma~     Hcy levels and blood pressure values by using Enalapril Maleate and Folic Acid Tablets(as the~     program-based antihypertension) and recovery of CIN has been observed. Using univariate and~     multivariate Logistic regression to analyse the relationship between HHcy and CIN, and taking~     receiver operating characteristic (ROC) curve to select the best Hcy plasma levels that which~     can predict the CIN and the probability. This study will help us to understand the~     relationship between HHcy and CIN that course of the procedure in adults hypertensive~     patients, preoperative plasma Hcy levels can predict the incidence of CIN and whether~     Enalapril Maleate Folic Acid tablets can reduce the CIN of hypertensive patients with HHcy.~     Which has important clinical significance. This study also offer feasibility for further~     research that HHcy plays a role in pathogenesis and specific signaling pathways of CIN.~   "
75777|NCT02575079|"~     The purpose of this study is to see if applying parafilm as an external barrier on the~     central line in children having a bone marrow transplant helps to prevent central line~     associated bloodstream infection(s) and also to assess the ease of use of parafilm.~   "
75778|NCT02575066|"~     Radiotherapy (RT) alone is able to induce a clinically significant effect with a variable~     pathologic response (a pathological complete remission, pCR, defined as ≥ 95%, or ≤ 5%~     remaining visible tumour cells) in only about 10% of cases. A prior phase I study (PASART-1;~     NCT01985295) suggested that 25 x 2 Gy preoperative RT in combination with once daily 800mg~     oral pazopanib is feasible, while inducing tissue replacing tumor that can consist of~     fibrosis and necrosis in 40% of thus treated patients.~   "
75779|NCT02575053|"~     Study objectives~      Primary objective:~      This study wants to evaluate the safety of a latex safe protocol as proposed by the~     Australasian Society of Clinical Immunology and Allergy. In other words,the investigators~     hope to demonstrate that patients with known latex allergy or latex sensitisation can be~     treated safely in operating theatres without special requirements towards scheduling provided~     that all powdered latex gloves are removed from the OR environment( preparation rooms,~     theatres, recovery room and surroundings). In contrast, earlier guidelines require the~     theatre to be left unused during at least 3 hours before a patient with suspected latex~     allergy can be operated on in this theatre.~      Secondary objectives:~        -  The investigators want to evaluate to what extend patients who report a latex allergy~          show risk factors of latex allergy.~        -  To investigate to what extend latex allergy was proven by laboratory testing or skin~          testing in patients who report a latex allergy.~        -  Type of latex allergic reaction when patients report a latex allergy.~        -  The level of satisfaction of surgeons and OR scheduling staff with the new latex safe~          protocol and with the switching to powder free latex gloves.~   "
75780|NCT02575040|"~     The gut microbiota is determined to constitute a microbial organ which has pivotal roles in~     the intestinal diseases and body's metabolism. Evidence from animal and human studies~     strongly supports the link between intestinal bacteria flora and inflammatory bowel diseases.~     Lots of studies showed its efficacy in treatment of severe Clostridium difficile colitis.~     Corticosteroid dependence in patients with ulcerative colitis (UC) and Crohn's disease (CD)~     is an important clinical problem and maintenance of steroid-free remission is a key treatment~     goal. Early studies using fecal microbiota transplantation (FMT) for Ulcerative Colitis (UC)~     and Crohn's diseases have also met with success. This is an first step into investigating the~     potential efficacy of standardized FMT through terminal ileum for UC and CD, the~     investigators propose to determine the efficiency and safety of FMT in a series of 80~     patients with moderate to severe UC and CD.~   "
75781|NCT02575027|"~     This pilot clinical trial studies the feasibility of palliative 4pi radiotherapy in treating~     patients with glioblastoma multiforme that has come back after standard chemoradiation. A new~     radiotherapy delivery planning system, called 4pi radiotherapy, may help improve radiation~     delivery by improving dose coverage to the treatment target, while reducing the dose to~     surrounding normal tissues.~   "
75782|NCT02575014|"~     The primary objective of this study is to assess the safety, tolerability and toxicity of~     preoperative HBOT in patients undergoing a pancreaticoduodenal resection for premalignant and~     malignant tumors of the common bile duct, periampullary and duodenum.~   "
75783|NCT02575001|"~     The aims of this study are two fold: To show whether there is an increased environmental or~     genetic susceptibility to stress in patients with T1D and whether it influences diabetes~     management. And to develop a strategy for the assessment and treatment of patients with T1D~     and an increased risk for development of psychopathology under stress.~   "
75784|NCT02574988|"~     The multicenter registry of patients with severe cutaneous adverse reactions among tertiary~     medical institutes in Thailand to study clinical characteristics, etiologies, therapeutic~     outcomes, quality of life, and the values of in vitro drug allergy diagnosis for the~     confirmation of the causative drugs~   "
75785|NCT02574975|"~     Bronchial asthma is a common chronic respiratory disease. Patients usually manifest variable~     symptoms (such as short of breath, chest tightness, cough, etc.) and variable airflow~     limitation and often associated with airway hyper-responsiveness and airway inflammation.~     About 1-18% of the global population suffered from the disease, causing huge economic burden~     for patients and countries. Airway reactivity measurement is an important way of diagnosis of~     asthma. Methacholine (Mch) bronchial provocation test(BPT) is the gold standard for the~     determination of airway reactivity, and other measuring methods(like adenosine~     monophosphate(AMP)-BPT, leukotriene D4(LTD4)-BPT, Astograph-BPT, etc.) were also brought into~     hot research fields. The investigators' purposes were to compare different kinds of~     methodologies(Mch,AMP,LTD4-BPT, Astograph-BPT) assessing airway responsiveness and to~     investigate treatment efficacy of budesonide /formoterol in asthmatics.~   "
75786|NCT02574962|"~     The purpose of this pilot study is to assess the safety and efficacy of Acthar® Gel in~     Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) patients.~   "
75790|NCT02574910|"~     Children with congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency tend to~     have elevated circulating levels of androgens, which can accelerate skeletal maturation and~     adversely impact adult height. Additionally, these children require supraphysiologic doses of~     hydrocortisone to suppress secretion of adrenal androgen precursors, and this treatment can~     retard linear growth. This study seeks to use oral abiraterone acetate (Zytiga)as an adjunct~     to approved CAH therapy (oral hydrocortisone and fludrocortisone) for pre-pubescent children~     with classic 21-hydroxylase deficiency in order to reduce daily requirement of~     hydrocortisone. In this Phase 1 study, the investigators will determine the minimum effective~     dose of abiraterone acetate that normalizes androstenedione levels during the 7-day Treatment~     Period.~   "
75791|NCT02574897|"~     The purpose of this randomized trial will evaluate whether providing clinicians with daily~     reports from a well-validated, standardized, patient-centered electronic symptom survey tool~     (PRO-CTCAE) improves symptom burden in patients undergoing high-dose chemotherapy. Adult~     inpatients at UNC undergoing high-dose chemotherapy for preparative chemotherapy prior to~     stem cell infusion. Participants will be randomized into one of two arms: (1) a control arm~     with standard of care daily clinician interviews or (2) standard of care plus daily~     electronic symptom surveys, the results of which will be sent to clinicians electronically.~   "
75792|NCT02574884|"~     The study consists to Identify viral variants involved in the transmission of hepatitis C and~     characterize the antigenic and functional properties of their envelope glycoproteins at very~     early stage of infection (before seroconversion).~   "
75793|NCT02574871|"~     This study consists of psychological and biological data collection for identification of the~     chronic stress presence in healthy adult subjects. The psychological data collected were the~     results provided by three different instruments: ISSL, PSS and SRRS. The biological data~     collected were the blood pressure, the skin temperature, the galvanic skin response, and the~     heart rate variability in time and frequency domain.~   "
75794|NCT02574858|"~     The purpose of this study is to evaluate the safety of orally administered QRH-882260, a~     topically administered Cy5-labeled heptapeptide specific for epithelial growth factor~     receptor (EGFR).~   "
75795|NCT02574845|"~     The primary objective of this trial is to investigate the relative bioavailability of~     rosuvastatin when given alone (Reference treatment, R) compared to when given together with~     one of the three different doses of metformin (10 mg, Test treatment 1 (T1); 50 mg (T2); 500~     mg (T3)) or one of the two doses of furosemide (1 mg (T4); 5 mg (T5)).~   "
75796|NCT02574832|"~     Cervical incompetence complicates approximately 1 in 500 pregnancies . Those women with~     cervical incompetence are at risk for second trimester spontaneous abortion and preterm~     labor. Cervical cerclage reduces these risks but must be performed under general or neuraxial~     anesthesia. Some anesthesiologists prefer neuraxial anesthesia, as it reduces fetal exposure~     to medications and avoids the risks associated with loss of maternal airway reflexes under~     general anesthesia. Spinal anesthesia, in particular, has the added advantage of being~     technically simple while still providing a rapid, dense sensory block. For cerclage~     placement, patients require a sensory block from the T10 to S4 dermatome in order to cover~     sensation from the cervix as well as the vagina and perineum. Patients presenting for~     cerclage under spinal anesthesia pose a dosing challenge given the physiologic changes~     associated with pregnancy. As women progress with their pregnancy, they require lower doses~     of intrathecal local anesthetic to achieve similar block level. Multiple studies have~     demonstrated that these changes start during the second trimester. Inadequate sensory~     coverage with a spinal anesthetic typically necessitates conversion to general anesthesia,~     causing additional time wasted and added risk to the patient and fetus. Anecdotally, this is~     the reason why some anesthesiologists choose general anesthesia for patients undergoing~     cerclage over a spinal anesthetic. As there is currently no literature determining the~     correct dosage for these patients, we propose a dose-response study to determine the ED90 of~     intrathecal lidocaine for adequate anesthesia for elective cervical cerclage placement.The~     findings of this study will help determine the minimum dose of intrathecal lidocaine~     necessary to provide adequate spinal anesthesia for cervical cerclage for 90% of women. This~     will help decrease the frequency of inadequate anesthesia for cervical cerclage.~   "
75797|NCT02574819|"~     This is a multicenter, randomized, double-blind , placebo-controlled trail to investigate the~     safety and efficacy of subcutaneous methylnaltrexone for treating opioid-induced constipation~     in patients with advanced illness.~   "
75798|NCT02574806|"~     Brain natriuretic peptide (BNP) is an important tool for diagnosis, risk stratification and~     prognosis in pediatric patients with heart failure1. In newborn, after delivery, the BNP~     plays an important role in cardiopulmonary hemodynamics by stimulating vasodilatation and~     diuresis. The gradual decrease in pulmonary pressure and the initiation of diuresis as~     expression of renal maturity could explain the subsequent decrease in serum values. This~     would suggest that, in healthy newborns, BNP values should be found within a given ranges.~     However, the evidence suggests an important variability in BNP values 2 - 4. In the other~     hand, in the newborn with respiratory distress BNP could have a high negative predictive~     value to rule out acute myocardial processes, as responsible for clinical deterioration, from~     infectious, metabolic or respiratory processes; with a potential of improvement in medical~     care. Even the increased use of this biomarker in clinical practice, until our knowledge, BNP~     normal values remain unknown in the healthy newborn. Therefore, the investigators performed a~     pioneer study to establish normal values in healthy newborn population. Multi-center,~     prospective and observational study was carried out. Objective: To establish normal BNP~     values in healthy newborn.~   "
75799|NCT02574793|"~     Glucose fluctuations present not only in patients with diabetes mellitus but also in subjects~     with normal glucose tolerance or impaired glucose regulation. People with Growth~     Hormone-Secreting Pituitary Adenoma and Cushing Syndrome are at risk of impaired glucose~     metabolism. Glycemic variability is poorly studied in the nondiabetic individuals. The aim of~     the study is to investigate the characteristics of glucose fluctuations in the newly~     diagnosed Growth Hormone-Secreting Pituitary Adenoma and Cushing Syndrome individuals.~   "
75813|NCT02574611|"~     An injury to the spinal cord (SCI) results in numerous medical complications, including~     gastrointestinal (GI) function. Individuals with SCI may experience severe constipation~     (prolonged stool retention), incontinence (accidents), and overall difficulty in bowel~     evacuation. While various treatments and medications have been established to address this~     complication, there is little knowledge relating to the overall colonic motility. However,~     new technology such as High Resolution Colonic Manometry allows physicians to visualize high~     pressure contractions inside the colon, leading to a greater understanding of typical~     motility, a more accurate diagnosis, and an effective treatment. In this study, the~     investigators propose to use this technology to understand the effects of SCI on colonic~     motility by comparing to normal colonic function observed in able-bodied (AB) individuals. In~     addition, the investigators plan to study the effects of pharmacological treatments, such as~     neostigmine, on promoting peristaltic contractions in the colon as it is delivered across the~     skin.~   "
75800|NCT02574780|"~     The stage and lymphedema size can be detrimental to the quality of life and health of women,~     because the increase in circumference and member of the weight causes limitations in~     activities. Previous studies have shown that patients with lymphedema should not perform high~     intensity exercises, these exercises would cause the increase of lymphedema. Already, in~     current studies show that muscle strength exercises when properly applied, with controlled~     intensity and time, can help to reduce lymphedema. Thus, the main objective of this study is~     to compare the standard treatment of lymphedema through complex physical therapy versus the~     application of strengthening exercises for upper limbs together with complex physical~     therapy. The study design is a randomized controlled clinical trial. Participate in the study~     50 patients, who will be allocated into two groups, group 1 (n = 25): Complex Physical~     Therapy; Group 2 (n = 25): Complex physical therapy in an exercise protocol, which will~     receive treatment twice a week for eight weeks. All patients will receive treatment and will~     be informed of the free and informed consent form at the beginning of the research. They will~     be met: the report cards, dynamometer testing and filling out questionnaires at the beginning~     and end of the study.~   "
75801|NCT02574767|"~     In Chile, 1 out of 4 pregnant women is obese (BMI > 30 kg/m2). This impacts negatively the~     health of the mother and the offspring during pregnancy. Lifestyle interventions are the~     primary prevention strategy for gestational diabetes in obese women; however, these~     interventions have shown null or limited effectiveness. In animals, n-3 long-chain~     polyunsaturated fatty acid (n3LC-PUFAs) have shown to increase insulin sensitivity through~     higher production and secretion of adipokines, enhanced fatty acids oxidation, reduction of~     lipogenesis, and direct anti-inflammatory effects; however evidence in humans and during~     pregnancy is still very limited. Combining a lifestyle intervention with n3LC-PUFAs~     supplementation could enhance the metabolic control of obese pregnant women. Objective: to~     assess the effectiveness of two prenatal nutritional interventions (home-based diet and~     physical activity counseling and/or n3LC-PUFAs supplementation) delivered to obese pregnant~     women in achieving better metabolic control in both the mother (lower incidence of~     gestational diabetes mellitus) and the offspring (lower incidence of macrosomia and lower~     prevalence of insulin resistance at birth).~      Methods: this study is a cluster-randomized trial in which obese pregnant women from 12~     primary health care centers (PHCC) will be stratified by socio-economic status (SES) and~     randomized to one of four parallel study arms. We will recruit 1000 women allocated to: 1~     Home-based Diet and physical activity (PA) plus n3LC-PUFAs supplementation (Intervention~     Group 1, n=250); 2. Routine diet & PA counseling care plus n3LC-PUFAs supplementation~     (Intervention Group 2, n=250); 3. Home-based Diet and Physical activity plus placebo for~     n3LC-PUFA supplementation (Intervention Group 3, n=250); 4. Routine diet & PA counseling plus~     placebo (Control Group, n=250). Expected results: we expect that the intervention will~     contribute to achieving a better metabolic control during pregnancy. Ultimately, we expect~     that this study will contribute to advance the understanding of how to develop and implement~     effective actions to promote healthier pregnancies and therefore, healthier lives for mothers~     and their offsprings.~   "
75802|NCT02574754|"~     The purpose of this study is to assess the 2012 bioequivalence statistical criteria for~     warfarin, a narrow therapeutic index drug, set forth in the draft guidance issued by the Food~     and Drug Administration (FDA).~   "
75803|NCT02574741|"~     The study will consist of two main elements: the enrollment of 72 children aged 6-11 years~     with ASD and low language competency to receive a thrice-weekly one hour language~     intervention for 12 weeks; and, beginning at the same time, subjects will be equally~     randomized to receive either aripiprazole (Abilify) (flexibly dosed from 2-10 mg per day) or~     placebo for 12 weeks.~   "
75804|NCT02574728|"~     This study aims to determine the efficacy of daily sirolimus and celecoxib, with low dose~     etoposide alternating with cyclophosphamide for pediatric participants with relapsed or~     refractory tumors.~   "
75805|NCT02574715|"~     This is a cross-sectional, multicenter observational study to assess quality of life in young~     Spanish women (aged 18 to 29) who use Jaydess® as their contraceptive method. The study will~     be conducted in standard clinical practice conditions at the private gynecology clinics and~     during a single study visit.~      Approximately 1,200 women who have been using the intrauterine delivery system (IUS) Jaydess®~     as their contraceptive method of choice for 6 (±1) months will be included in the study.~   "
75806|NCT02574702|"~     1. Introduction:~           The most common complication of loop ileostomies closure for rectal cancer patients~          undergoing a low anterior rectum resection, is the superficial surgical site infection~          (incidence 2-40%). There are various techniques related to closing loop ileostomy. In a~          retrospective study at our center, the investigators objectify that superficial surgical~          site infection rate was reduced by more than a half by the application of a~          contralateral drainage (Penrose ®) in primary loop ileostomy closure.~        2. Objectives and Hypothesis:~           Hypothesis: The application of a contralateral drainage (Penrose ®) in primary loop~          ileostomy closure (in carriers of loop ileostomy by a low anterior rectum resection for~          rectal cancer) reduces the superficial surgical site infection.~           Main objective: To reduce the rate of superficial surgical site infection by the~          application of a contralateral drainage (Penrose ®) in surgical wound of primary loop~          ileostomy closure.~        3. Methodology:~      Prospective and randomized clinical trial on the effectiveness of contralateral Penrose®~     drainage implementation in those patients that have a primary loop ileostomy (by low anterior~     rectum resection) closure to be able to know if the investigators can reduce the superficial~     surgical site infection rate. Monitorization until 30 days after surgery~   "
75807|NCT02574689|"~     This pilot study represents an initial foray into delivering home-based individually-tailored~     physical activity interventions for cancer risk reduction among African American women in the~     Deep South.~   "
75808|NCT02574676|"~     This is an online registry to document the psychometric properties of SF-36v2 among patients~     with AL Amyloidosis, to document patients' burden of disease, to better understand the~     patient's experience and to follow quality of life issues using a variety of QOL measures.~   "
75809|NCT02574663|"~     This is a Phase 1 multi-center study to assess the safety and efficacy of TGR-1202 as a~     single agent or in combination with nab-paclitaxel + gemcitabine or with FOLFOX in patients~     with select relapsed or refractory solid tumors.~   "
75810|NCT02574650|"~     The purpose of this study is to assess the early safety and performance of the Mitralign~     Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for the treatment of symptomatic~     chronic functional tricuspid regurgitation (FTR).~      The procedure will be performed with the PTVAS device using a non-surgical percutaneous~     approach to tricuspid valve repair in patients who have FTR with a minimum of moderate~     tricuspid regurgitation.~   "
75811|NCT02574637|"~     A Phase 2b study to evaluate the efficacy and safety of MEDI2070 in Subjects with Moderate to~     Severe Crohn's Disease Who Have Failed or Are Intolerant to Anti Tumor Necrosis Factor-Alpha~     Therapy~   "
75812|NCT02574624|"~     To Assess the Safety of Vitreous surgery with intraocular assistance (VISIA) & to identify~     and document with video evidence and surgeon's case report forms intraocular maneuvers that~     are facilitated by VISIA.~   "
75814|NCT02574598|"~     This is a phase II open-label randomized clinical trial of MK-3475 (Pembrolizumab) on~     previously treated PDL1 positive non-small cell lung cancer (NSCLC) patients . This drug has~     shown to allow partial response according to the immune-related response criteria and the~     response evaluation criteria in solid tumors (RECIST). The main endpoint is to compare the~     overall response rate (ORR) of MK-3475 with docetaxel or docetaxel alone in patients with~     advanced NSCLC.~   "
75815|NCT02574585|"~     The purpose of this study is to analyze the safety and efficacy of autologous bone marrow~     mesenchymal stem cell transplantation in patients with thoracolumbar chronic and complete~     spinal cord injury.~   "
75816|NCT02574572|"~     The purpose of this study is to analyze the safety and efficacy of autologous bone marrow~     mesenchymal stem cell transplantation in patients with cervical chronic and complete spinal~     cord injury.~   "
75817|NCT02574559|"~     The purpose of this study is to determine if caregivers of children with a developmental~     delay experience a decrease in stress by participating in a meditation/cognitive training~     protocol.~   "
75818|NCT02574546|"~     This research is being done to learn more about the risk of developing breast cancer by~     studying cells from both normal breast tissue and breast cancer tumor tissue. The goal is to~     study cells, genes, and gene products to help us to learn how to detect cancer in its~     earliest stages, and if this information may differ in patients with different ethnic~     backgrounds.~   "
75819|NCT02574533|"~     This is an open label Pilot study to evaluate the combination of Vigil™ and pembrolizumab in~     patients with incurable locally advanced or metastatic melanoma. Patients undergoing a~     standard of care surgical procedure (e.g., tumor biopsy, palliative resection) and meeting~     procurement eligibility criteria may have tumor harvested for Vigil™ vaccine manufacture.~     This study evaluates the hypothesis that vaccination with Vigil™ will induce cancer-specific~     T cell immunity in these patients. Addition of pembrolizumab to Vigil™ treated patients will~     further augment these immune changes on sequential biopsy when comparing post-Vigil™ but~     pre-PD-1 inhibitor to post-PD-1 inhibitor biopsies, and the combination therapy will be~     associated with reduction of tumor volume on clinical exam and/or imaging.~   "
75820|NCT02574520|"~     This is a research study of SABER® -Bupivacaine, an experimental medication designed to~     relieve pain for up to 3 days after surgery. Given once by the surgeon at the end of surgery,~     SABER® - Bupivacaine delivers a locally-acting pain reliever directly to the surgical wound.~      The purpose of this study is to measure how well it works in reducing pain after laparoscopic~     cholecystectomy (surgery to remove the gall bladder) and to investigate the safety of~     SABER®-Bupivacaine (its side effects).~   "
75821|NCT02574507|"~     The objective of the study is to develop and test the feasibility, acceptability, and initial~     efficacy of a novel couples-based behavioral weight and symptom management intervention for~     obese breast cancer survivors and their partners. The proposed project consists of two~     phases. Phase I will include intervention development and refinement. Intervention~     development will be guided by the research team's prior work, the interdependence model of~     communal coping and behavior change, and information obtained from couples participating in~     focus groups. The intervention protocol will then be tested with 5 couples to assist with~     refinement of intervention content. During phase II, the feasibility, acceptability and~     initial efficacy of the intervention will be examined. Obese breast cancer survivors in the~     first year following treatment and their overweight or obese partners will receive 6 weekly~     and 6 biweekly sessions for a total of 12 sessions spaced across approximately 5 months. The~     intervention will be provided in a couples-based format where each couple will meet~     separately with the therapist. Couples will be assessed at pre-, post-, and 3-months~     post-treatment. Study outcomes will be weight, symptoms (i.e., pain, fatigue, distress),~     eating behavior, and physical activity. Exploratory outcomes examine biomarkers (i.e.,~     insulin, IL-6, IL-8, TNF-alpha, adiponectin) associated with health outcomes for cancer~     survivors and their partners. It is hypothesized that the intervention will be feasible~     (i.e., completed sessions), and participants will find the intervention acceptable as~     assessed by a measure of treatment acceptability. It is also hypothesized that participants~     will evidence decreased weight and improvements in symptoms (i.e., pain, fatigue, distress),~     eating behavior, and physical activity, and their change in weight will covary with change in~     symptoms, eating behavior, and daily physical activity. Finally, it is hypothesized that~     participants with greater weight loss will evidence improved functioning in insulin, IL-6,~     IL-8, TNF-α, adiponectin, and heart rate.~   "
75822|NCT02574494|"~     The primary aim is to establish whether breastfeeding is associated with lowering blood~     pressure in hypertensive women.~   "
75823|NCT02574481|"~     The primary objective of this trial is to evaluate the safety and effectiveness of the Boston~     Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for~     treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions up~     to 140 mm in length.~      Long Lesion Substudy: to evaluate the safety and effectiveness of the Boston Scientific~     Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating~     Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions >140 mm and ≤~     190 mm in length.~   "
75824|NCT02574468|"~     Abstract Aim The aim of this randomized clinical trial was to histologically investigate~     possible effects of dexamethasone application on pulp tissue healing during one step mineral~     trioxide aggregate (MTA)-direct pulp capping (DPC) and miniature pulpotomy (MP) in healthy~     human premolar teeth.~      Methodology Forty intact premolar teeth of 10 orthodontic patients, scheduled for extraction,~     were randomized for DPC (n=20) or MP (n=20). A high speed bur under copious water coolant was~     used for mechanical exposing of buccal pulp horn site. Prior to sealing with white ProRoot~     MTA, 10 out of twenty pulpal wounds of each group were randomly received dexamethasone.~     Cavities were restored with glass ionomer. Teeth vitality was evaluated in 7, 21, 42, and 60~     day follow-ups. Signs and/or symptoms of irreversible pulpitis or pulp necrosis were~     considered as failure. After 60 days, the teeth were extracted and submitted for histological~     examination. Kruskal-Wallis and Fisher exact tests were used for statistical analysis of the~     data (P=0.05).~      HTTP://www.accessdata.fda.gov/scripts/cred/drugsatfda~   "
75825|NCT02574455|"~     This is an international, multi-center, open-label, randomized, Phase III study in patients~     with metastatic TNBC refractory or relapsing after at least 2 prior chemotherapies (including~     a taxane) for their metastatic disease. Patients meeting eligibility will be randomized 1:1~     to receive either sacituzumab govitecan or treatment of physician choice (TPC), which needs~     to be selected prior to randomization from one of the 4 allowed regimens. Randomization will~     be stratified by number of prior chemotherapies for advanced disease (2-3 vs > 3) and~     geographical location (North America vs Europe).~      Patients will be treated until progression, unacceptable toxicity, study withdrawal, or~     death, whichever comes first. Tumor progression leading to treatment withdrawal will be~     assessed by the investigator. Starting with the initial dose of sacituzumab govitecan or TPC,~     CT scans (or MRI if contrast allergic) will be obtained at least every 8 weeks until the~     occurrence of progression of disease requiring discontinuation of further treatment.All~     patients, including those prematurely terminating study participation, will be followed every~     4 weeks during the first year and every 8 weeks thereafter for survival follow-up.~   "
75827|NCT02574429|"~     Even though borderline personality disorder (BPD) and posttraumatic stress disorder (PTSD)~     commonly co-occur, few studies have examined PTSD treatment among individuals with BPD.~     Additionally, many PTSD research studies exclude individuals with BPD due to their complexity~     and concerns regarding risk. This study aims to investigate the effectiveness of~     Cognitive-Processing Therapy Group (an evidenced-based treatment for PTSD) for individuals~     with these co-occurring disorders following completion of a Dialectical Behavioural Therapy~     Program (an evidenced-based treatment for BPD). The investigators are using a repeated~     measures pre and post design. Data will be collected prior to participants starting the CPT~     group, throughout the duration of the CPT group (i.e., weekly), and following the completion~     of the CPT group.~   "
75828|NCT02574416|"~     Although increasing age is associated with declining health and function, there are wide~     variations between individuals in the ageing process. Some of these differences are explained~     by differences in lifestyle, but little is known about the determinants of lifestyle in older~     age. The proposed project will describe influences on health behaviour and lifestyle in older~     adults. Investigators will undertake a prospective study of community-dwelling older people~     who use any of the Medicine for Older People Services in Southampton, allowing us to gain~     obtain important insights into the relationship between health behaviour, lifestyle and~     health outcomes in older people. Our principal aim is to identify key points on the ageing~     pathway when interventions may be best targeted to promote health. The findings of this~     project will underpin the design for a complex intervention to be conducted in the future to~     improve the health outcomes of older people.~   "
75829|NCT02574403|"~     Atypical hemolytic syndrome (aHUS) is a severe renal disease affecting children and adults.~     It is characterized by the occlusion of intrarenal vessels due to the presence of~     platelet/fibrin thrombi, and leads to end-stage renal disease in up to 2/3 of patients. The~     discovery of complement alternative pathway as a major risk factor for aHUS has led to the~     design of a disease-specific treatment, the anti-C5 monoclonal antibody, eculizumab.~     Complement inhibition using eculizumab has clearly improved the renal outcome of aHUS~     patients with a dramatic decrease in the risk of end-stage renal disease. However, the~     optimal duration of eculizumab therapy is still debated. The present study aims to assess the~     feasibility and safety of the discontinuation of eculizumab treatment in children and adults~     with aHUS.~   "
75830|NCT02574390|"~     Creation of a large repository of induced pluripotent stem cells (iPSC), bio-fluid samples~     (blood and spinal fluid (optional)), and cell lines for ALS gene identification. This will be~     combined carefully with collected measures of the pattern of the symptoms people with ALS~     have and how these change over time. People with other motor neuron diseases and healthy~     controls will be included as comparisons~   "
75831|NCT02574377|"~     This is an interventional study to test the immunogenicity of combined adjuvant myDC and pDC~     vaccination versus adjuvant myDC or pDC vaccination alone in stage III melanoma patients.~   "
75832|NCT02574364|"~     The traditional open appendectomy in the clinical effect is not prefect, and for a long time~     there is no measurable improvement. The application of abdomen CT before surgery provides a~     new approach to the incision and new perception.~      In a randomized controlled trial of modified incision versus traditional incision. Length of~     hospital day was the primary terminus, while operating time, postoperative complication, scar~     and time to resume normal activity and work as secondary terminus.~   "
75833|NCT02574351|"~     To study whether the immune response as directed by regulatory T cells is different between~     obese asthmatics, normal weight asthmatics and healthy controls.~   "
75834|NCT02574338|"~     The aim of this study is to compare the effectiveness and safety of Foley's catheter and~     misoprostol in cervical ripening.~   "
75835|NCT02574325|"~     Primary objective To investigate the effect of a 24-week, twice daily dosing regimen of~     ARI-3037MO compared to placebo on plasma triglyceride (TG) levels, liver enzymes and hepatic~     fat content in patients with dysglycemia and hepatic steatosis due to nonalcoholic fatty~     liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH). Secondary Objective To~     investigate the safety and tolerability of a 24-week, twice daily dosing regimen of~     ARI-3037MO compared to placebo in patients with dysglycemia and evidence of NAFLD or NASH.~   "
75836|NCT02574312|"~     This post-marketing investigation will evaluate the mechanical axis alignment achieved with~     the ATTUNE Single-Use Instrumentation (SUI) as compared to the mechanical axis alignment~     achieved with the ATTUNE Reusable Instrumentation (RUI) in primary cemented Total Knee~     Arthroplasty.~   "
75837|NCT02574299|"~     The ability to encode the speech signal is determined by ascending and descending auditory~     processing. Difficulties in processing these speech signals are well described at the~     behavioral level in a specific language disorder. However, little is known about the~     underlying pathophysiological mechanisms. The assumption is that we should observe a~     degradation of the signal provided by the ear in the deaf subject while in case of specific~     language impairment it would be a phonemic disorder (possibly linked to a processing disorder~     auditory). The two population groups should therefore have different abnormalities of their~     central auditory process - which could be modified by the target remediation for each group.~   "
75838|NCT02574286|"~     To evaluate the effect of VPRIV® therapy on patients with type 1 Gaucher disease by measuring~     the change in the lumbar spine (LS) and bone mineral density (BMD) after 24 months of~     treatment.~   "
75839|NCT02574273|"~     Several independent evaluations have supported the effectiveness of the Secret Agent Society~     (SAS) Program in improving the social-emotional functioning of children with Autism Spectrum~     Disorders (ASD) in clinic- (Beaumont & Sofronoff, 2008; Tan, Mazzucchelli & Beaumont,~     submitted), school-(Beaumont, Rotolone & Sofronoff, in press; Einfeld et al., submitted) and~     remote Skype/telephone-assisted delivery contexts (Sofronoff, Silva & Beaumont, in press).The~     present study aims to extend on the above literature by conducting a 6-month randomized~     controlled trial evaluating the effectiveness, utility and acceptability (including cultural~     acceptability) of the Secret Agent Society (SAS) social-emotional skills training program.~     Specifically, the study aims to evaluate the effectiveness of the SAS Program for 8-12~     year-old children with social difficulties in the context of a range of diagnosed mental~     health conditions and/or developmental disorders, including anxiety disorders, ADHD, and~     Autism Spectrum Disorder.~   "
77408|NCT02553772|"~     This study will evaluate the safety and efficacy of a new eye drop formulation in patients~     with dry eye disease.~   "
75841|NCT02574247|"~     The purpose of this study is to determine how changes in speech perception resulting from a~     computerized auditory training program are related to concurrent changes in auditory~     brainstem function resulting from the training. It is hypothesized that the degree of~     improvement in speech perception will be correlated with the degree of change in brainstem~     function.~   "
75842|NCT02574234|"~     No successful strategy is proposed to patients submitted to important surgery to reduce the~     incidence of postoperative cognitive disorders (POCD) onset. This project propose to measure~     plasma levels of apelin in wide population submitted to orthopedic surgery. Apelin could be~     involved in anti-inflammatory processes. Apelin levels before and after surgery correlated to~     postoperative cognitive disorders symptom measured by PET-Scan could be an important~     predictive or diagnostic marker to adapt therapeutic strategy to fight against postoperative~     cognitive disorders.~   "
75843|NCT02574221|"~     This study is to evaluate the sensitivity of the molecular method and its ability to split a~     stannous fluoride toothpaste versus a negative control.~   "
75844|NCT02574208|"~     CDC recommends universal HIV testing in all adults, at least once during life, to reduce the~     pool of infected patients unaware of their status. Routine universal HIV testing can use~     classical ELISA tests from serum, or rapid tests, ideally from finger-stick whole blood~     (FSB), which have shown close predictive values from classical tests. The investigators will~     compare the acceptability and feasibility of the two methods.~   "
75845|NCT02574195|"~     The main aim of the present study is to evaluate the prevalence of individual microvascular~     and macrovascular complications among diabetes mellitus patients and to determine the~     percentage of diabetes mellitus patients achieved HbA1c<7,0%.~   "
75846|NCT02574182|"~     Walking, Brain and Functional Magnetic Resonance Imaging Study of motor representations in~     healthy subjects and amnesic MCI.~   "
75847|NCT02574169|"~     This study aims to compare 2 alveolar recruitment maneuvers (ARM) in patients with cerebral~     injuries and acute respiratory distress syndrome (ARDS) in term of efficacy and tolerance.~   "
75848|NCT02574156|"~     The investigators aim to study the impact of a strategy of a intensive glycemic control in~     patients undergoing cardiac surgery.~   "
75849|NCT02574143|"~     The purpose of this study is to study the epidemiology of non-CF bronchiectasis (NCFB) and to~     provide an estimate of the distribution (prevalence) of NCFB etiologies across all different~     levels of health care as well as real-life data regarding the current management of NCFB in~     Germany.~   "
75850|NCT02574130|"~     The purpose of this study is to determine the cure rate from ventilator-associated pneumonia~     (VAP) caused by Gram negative bacteria when administering add on nebulized amikacin to~     intravenous antibiotics compared to intravenous antibiotics alone.~   "
75851|NCT02574117|"~     Maxillary expansion was performed for adult female patients suffering from maxillary~     constriction with bilateral posterior cross-bite using fixed Quad-helix appliance, for about~     8 months. The appliance was delivered and activated at the day of corticotomy and bone graft.~     The activation was made half-molar unit each side. The patient was scheduled each month to~     activate the appliance or reactivate if needed. Corticotomy was performed at area of~     maxillary 1st premolar, 2nd premolar and first molar. Cone beam computed tomography was~     performed, before appliance activation and corticotomy, at the end of expansion (8 months)~     and after finishing orthodontic treatment (average 2.5 years from start of treatment).~   "
75852|NCT02574104|"~     Complex service interventions are neither smooth nor easy in any transitioning healthcare~     facility. Simulations performed in the new environment reinforce patient safety by uncovering~     safety threats, enabling their correction, and orienting hospital staff. This study expands~     upon patient safety successes at several institutions to measurably enhance patient safety at~     upcoming new inpatient facilities.~   "
75853|NCT02574091|"~     This is a phase I study to evaluate the safety, tolerability and pharmacokinetics of Icotinib~     Hydrochloride Cream in healthy adults and patients with mild to moderate psoriasis.~   "
75854|NCT02574078|"~     The purpose of this study is to determine whether nivolumab monotherapy or in combination~     with Standard of care (SOC) therapies will provide clinical benefit (i.e., PFS, OS, and DOR)~     without unacceptable toxicity in advanced Non-Small Cell Lung Cancer patients.~   "
75855|NCT02574065|"~     Infant colic is a common condition characterized by excessive crying. The otherwise healthy~     infant aged less than 3 months is difficult to console during the periods with crying. The~     condition is defined by modified Wessel's criteria i.e. crying for more than 3 hours of the~     day, for more than 3 days of the week for at least 1 week.~      The description of infant colic hasalso been defined by Rome III diagnostic criteria~     andincludes infants from birth to 4 months of age,without failure to thrive, that are showing~     paroxysms of irritability, fussing or crying that starts and stops without obvious cause. The~     episodes last 3 or more hours/day and occur at least 3days/week for at least one week. The~     infant has no signs of central nervous system or intrinsic developmental difficulties, is~     normal on physical examination, and has normal growth patterns.~      Although infant colic is considered to be self limiting it is a distressing problem for~     families. It is in fact one of the most common reasons why parents seek the advice of a~     paediatrician or family practitioner during their child's first 3 months of life Up to 20% of~     infants under three months are affected by infant colic.~      Infant colic could have significant adverse effects on family quality of life and could even~     be a trigger for shaken baby syndrome. Parental perception associated with colicky complaints~     is therefor strongly recommended to be an outcome measure in trials of infantile colic.~      Measurement of parental/family quality of life and parental perception of colic severity with~     the help of a Visual Analogue Scale (VAS) in a Polish study showed that the use of a~     probiotic, Lactobacillus reuteri DSM 17938, could improve the perceived problems.~      The relationship between infant colic and gastroenterological, allergical and psychological~     disorders later in childhood was studied in a prospective study on 96 infants divided into~     two groups, colicky and non-colicky. The children diagnosed with infant colic, showed an~     increased susceptibility to recurrent abdominal pain, allergic and psychological disorders in~     childhood when they were 10 years old.~      The aetiology of infantile colic seems to be multifactorialbut is,despite many years of~     research, still unknown. The intestinal microbiota differs between infants with and without~     colic and has therefore been suggested to have a potential role. Other possible explanations~     are for example gut motility disturbances, low-grade mucosal inflammation and visceral~     hypersensitivity.~      Evidence suggests thatadministration of the probioticL. reuteri DSM 17938 might offer some~     benefit.L. reuteri DSM 17938 has been tested for its effect on crying in colicky infants and~     has been demonstrated to have a significantly favourable effect on crying time in fivetrials.~     One is a randomized trial that compared the probioticto Simethicone; three areplacebo~     controlled randomized double blind trials and yet another is a placebo controlled randomized,~     single blind, observational study. A fifth studydid not find any effect.~      Combining the results in a meta-analysis from three double blind, placebo controlled~     randomized trials (published at the time of the analysis, including the neutral one) found~     that, compared with placebo, L. reuteri administration reduced crying time at day 21 with~     about 40 min.~      Recently it has been documented in a clinical trial that prophylactic use of L. reuteriDSM~     17938during the first three months of lifereduced the onset offunctional gastrointestinal~     disorders, particularly functional constipation, regurgitation and infantile colic.~      In conclusion, the administration L. reuteri DSM 17938 may reduce the crying time in children~     with infantile colic, especially those fed predominantly or exclusively with breast milk.~     However, further randomized controlled studies, are required to be able develop~     recommendations in the management of infant colic.~      The present trial is undertaken to further document the effect of L. reuteri DSM 17938 on~     crying in colicky infants.~   "
75856|NCT02574052|"~     The purpose of this study is to evaluate whether exposure to nutrition information with or~     without nutrition education would influence college students' dietary choices and improved~     the previous photographs-based dietary assessment tools.~   "
75857|NCT02574039|"~     A diet rich in whole grain is inversely associated with cardiovascular disease risk and this~     benefit could be partly attributed to the phenolic acid content of whole grains. The exact~     absorption, metabolism and excretion of whole grain phenolic acids, however, is not fully~     understood. In a small human intervention trial, the investigators will investigate to what~     extent phenolic acids from whole grain oats are absorbed, excreted in urine and how they are~     metabolised.~   "
75858|NCT02574026|"~     The study aims at mapping the magnetoencephalographic (MEG) activities induced in normal~     volunteers by tapping the finger .~   "
75859|NCT02574013|"~     To achieve an adequate visual working field during laparoscopic colorectal surgery without~     disturbance of the small intestine, patients are positioned in Trendelenburg position. This~     position results in hemodynamic changes which may increase the risk of cardiopulmonary~     complications and prolonged hospital stay. Recently, an intraoperative retractor sponge was~     introduced as alternative for the Trendelenburg position during laparoscopic surgery.~   "
75860|NCT02574000|"~     This is an observational study to address the following questions.~        1. How many people develop stroke-shoulder pain within 3 days of stroke?~        2. How many people have stroke shoulder pain at 8-10 weeks after stroke?~        3. Does having stroke-shoulder pain within 3 days of stroke predict the likelihood of~          having stroke-shoulder pain at 8-10 weeks?~        4. What are the best bedside examination tests to identify stroke-shoulder pain?~   "
75861|NCT02573987|"~     determine if efficiency of MEOPA anesthesia is at least equivalent to local anesthetics into~     the chorionic villus sampling in the first trimester of pregnancy~   "
77610|NCT02551133|"~     This study evaluates the effect of dexamethasone on persistent surgical pain after mastectomy~     operations. Half of the participants will receive 0.1 mg/kg dexamethasone and the other half~     will receive 0.2 mg/kg dexamethasone.~   "
75862|NCT02573974|"~     Undernutrition associated with cancer, or cancer cachexia results from a deterioration of the~     energy balance that leads to a gradual mobilization of energy reserves in the body and to~     increasing deterioration of the nutritional status of patients. This will thus significantly~     reduce quality of life and survival of patients with a lower tolerance to cancer treatments.~     Despite undeniable progress in knowledge, many pathophysiological mechanisms remain few or~     not explored, which could explain that there is still no satisfactory therapeutic solution to~     halt the gradual deterioration of the nutritional status of patients. In this sense, apart~     from preclinical data obtained in animal models, there is currently no clinical study on the~     functioning of skeletal muscle energy metabolism in undernourished patients suffering of~     cancer.~   "
75863|NCT02573961|"~     The purpose of this study is to compare the effects of laser acupuncture and high protein low~     carbohydrate diet on the treatment of obesity and lowering of endothelial markers.~   "
75864|NCT02573948|"~     This study aims at assessing the feasibility of implementing an interventional cohort of~     people who inject drugs in Haiphong, Viet Nam.~      For this purpose, the investigators will conduct a RDS survey to i) assess the current~     situation of drug use behaviour, HIV and Hepatitis C Virus (HCV) infection in the study~     population and ii) recruit participants for the longitudinal phase. The latter will consist~     of enroling the most difficult to reach People Who Inject Drugs (PWID) (those not followed by~     health centers), including early injectors, Men who have Sex with Men (MSM) and female sex~     workers (FSW) and following them up for 6 months in order to estimate the follow-up rate and~     preliminary estimates of HIV and HCV incidence.~   "
75865|NCT02573935|"~     This study evaluates the potential synergic anti-myeloma activity of clarithromycin when~     combined with VCD induction therapy in patients with newly diagnosed multiple myeloma.~   "
75866|NCT02573922|"~     In the present study, the primary aim was to evaluate if oxycodone-naloxone combination~     compared to oxycodone reduced opioid induced constipation in patients with or without chronic~     opioid treatment undergoing spine surgery.~   "
75867|NCT02573909|"~     There are conflicting results in earlier studies concerning the safety and efficacy of~     epidural oxycodone. In a study by Bäcklund and colleagues, epidural oxycodone was as~     effective as intravenous oxycodone, so they did not recommend epidural use of oxycodone. In~     another study, Yanagidate and Dohi reported that oxycodone was as effective in pain treatment~     with double dose compared to epidural morphine. In our previous study, epidural oxycodone~     provided safe and effective pain relief when compared to intravenous oxycodone.~      In the present study, the aim was to compare the efficacy and safety of epidural or~     intravenous oxycodone in patients undergoing elective gynecological surgery with planned~     epidural pain treatment.~   "
75868|NCT02573896|"~     This NANT trial will determine the maximum tolerated dose (MTD) of autologous expanded~     natural killer (NK) cells when combined with standard dosing of ch14.18 and will assess the~     feasibility of adding lenalidomide at the recommended Phase II dose of the expanded NK cells~     with ch14.18, for treatment of children with refractory or recurrent neuroblastoma.~   "
75869|NCT02573883|"~     This study is being done to compare the effects, good and bad, of fractionated CO2 laser~     treatment and clobetasol proprionate .05% ointment on vulvar lichen sclerosus.~   "
75870|NCT02573870|"~     Batefenterol inhalation powder is currently under development as a fixed-dose combination~     with fluticasone furoate (FF) for the treatment of Chronic Obstructive Pulmonary Disease~     (COPD).~      The present study will administer batefenterol/FF (300/100 micrograms [mcg]) for the first~     time to subjects with COPD, to investigate the safety and tolerability of the combination~     compared with placebo, and to evaluate the pharmacokinetics and pharmacodynamics profiles of~     the individual components when administered in combination.~      This is a Phase IIa, multicenter, randomized, placebo-controlled, double-blind, parallel~     group study. Subjects will be randomized (2:1) to one of the following double-blind treatment~     groups:~      Batefenterol/FF 300/100 mcg inhalation powder once daily, or matching placebo inhalation~     powder once daily.~      Subjects will self-administer the study treatments once daily (QD) in the morning for 42 days~     via a multi-dose dry powder inhaler (DPI) which contains two blister strips. Additionally, an~     inhaled short acting beta2-receptor agonist, albuterol will be provided from screening to the~     end of the treatment period for all subjects to use as needed to relieve COPD symptoms. At~     the end of the treatment period, subjects can resume conventional therapy.~      The study will randomize approximately 60 subjects. The total duration of subject~     participation (from screening to follow-up) will be approximately 8 weeks.~   "
75871|NCT02573857|"~     Part A~      -Cohort 1 DSM265 will be administered as a single dose (400 mg). For cohort 1 only, an~     additional single dose (400 mg) of DSM265 may be given if gametocytemia develops. Treatment~     with DSM265 will be given after an overnight fasting period of ≥ 8 hours. If dosing is to~     occur in the evening, subjects will be required to fast for ≥4 hours prior to receiving~     treatment. Subjects will be required to fast for a further four hours anytime after dosing~     with DSM265.~      Part B~        -  Cohort 2 OZ439 will be administered as a single 200 mg dose. If recrudescence is~          observed, a single 400 mg dose of OZ439 will be given. Treatment with OZ439 will be~          administered after an overnight fasting period of ≥ 6 hours. If dosing is to occur in~          the evening, subjects will be required to fast for ≥4 hours prior to receiving~          treatment. Participants will drink 200 mL of milk prior to drug administration, and then~          swallow the appropriate volume of OZ439 suspension. Subjects will be required to fast~          for a further six hours anytime after dosing with OZ439.~        -  Cohort 3 DSM265 will be administered as a single dose (400 mg) as described for cohort~          1. No additional dose will be administered.~   "
75872|NCT02573844|"~     The purpose of this study is to determine whether Proklama is effective in significative~     reduction of pain, other symptoms IBS's related, and improves quality of life concerning IBS~     disease.~   "
75873|NCT02573831|"~     Oxycodone is used to treat pain in early labor, however the effect of oxycodone to placental~     or fetal circulation has not been evaluated. Oxycodone is increasingly used to treat labor~     pain in the early phase. The aim of the randomised, double blinded, placebo controlled study~     was to evaluate the effects of oxycodone in placental circulation, efficacy and safety of~     oxycodone and the effects to the newborn.~   "
75874|NCT02573818|"~     The purpose of this study is to evaluate the users' responses to the SEDASYS® System alarms~     during esophagogastroduodenoscopy (EGD) or colonoscopy.~   "
75876|NCT02573792|"~     Optic neuritis (ON) can remain isolated or reveal a widespread and chronic disease of the~     central nervous system (CNS), a multiple sclerosis (MS) or, more rarely, a Devic's~     neuromyelitis optica (NMO) or a systemic disease.~      The optical coherence tomography (OCT) is a retinal imaging technique to measure the~     thickness of the retina and its different layers with an accuracy of 4-6 µM.~      Costello et al have shown that approximately 75% of 54 MS patients have developed within 3 to~     6 months after a ON a loss of 10 to 40 µM in the thickness of the peripapillary retinal nerve~     fiber layer (RNFL).~      The etiologic diagnosis of ON has been transformed in recent years. MS can now be diagnosed~     by McDonald's MRI criteria and NMO by the AQP4 antibodies (anti-aquaporin- 4) antibodies and~     the anti-MOG (myelin-oligodendrocyte glycoprotein) antibodies.~      The diagnosis and prognosis value of the OCT in patients with ON is not well known~   "
75877|NCT02573779|"~     A study to compare growth, development of the intestinal bacterial environment, and other~     short term outcomes in groups of babies fed primarily their own mother's milk compared to~     those who receive primarily donor human milk. The investigators hypothesize that infants who~     receive primarily their own mother's milk will have better growth, a more diverse intestinal~     bacterial environment, and possibly some improved short term outcomes such as better feeding~     tolerance and lower rates of infection.~   "
75878|NCT02573766|"~     The goal of this clinical research study is to learn if using a type of non-invasive therapy~     called neurofeedback training can help teach patients with peripheral neuropathy how to~     change their own brain waves to lower their perception of neuropathy and help improve their~     overall quality of life.~      Neurofeedback training is a type of therapy that uses an electroencephalograph (EEG) and a~     computer software program to measure brain wave activity.~      This is an investigational study. The equipment used for neurofeedback training is FDA~     approved and commercially available. Using neurofeedback equipment to teach patients ways to~     modify their own brain waves to lower the perception of symptoms and improve quality of life~     is considered investigational.~      Up to 99 participants over the age of 18 will take part in this study. All will be enrolled~     at MD Anderson.~   "
75879|NCT02573753|"~     The aggregate of microorganisms inhabiting the human body can be regarded as a dynamic~     reflector of both healthy and disease states, altering in response to changes in the~     environment. This may precede clinically detectable disease; and thereby, could be used to~     predict disease onset and additionally monitor response to treatment and predict prognosis.~     The overall hypothesis of this pilot study is that the human microbial communities are~     influenced by sleep and altered in humans with abnormal sleep patterns, and they may~     ultimately relate to disease risk.~   "
75880|NCT02573740|"~     This is a Phase 1, multicenter, randomized, double-blind, placebo-controlled, multiple dose~     study of ABT-957 in participants with mild Alzheimer's disease (AD) and Mild Cognitive~     Impairment (MCI) due to AD.~   "
75881|NCT02573727|"~     Continous infusion of nor adrenaline + albumin Continous infusion of terlipressin + albumin~     Response will assessed at every 48 hour (i) Complete response: Regression of acute kidney~     injury stage with reduction of S. Cr within 0.3 mg/dl of baseline (ii) Partial response:~     Regression of acute kidney injury stage with reduction of S. Cr to ≥0.3 mg/dl above baseline~     (iii) No response: No regression of acute kidney injury~      Treatment will be extended until reversal of HRS (decrease in creatinine below 1.5 mg/dL) or~     for a maximum of 7 days after rescue treatment will be followed.~      If intolerant to terlipressin, excluded from study and rescue treatment will be given in form~     of noradrenaline or octreotide and midodrine.~   "
75882|NCT02573714|"~     The purpose of this study is to determine if the use of ketamine, sniffed in the nose, is a~     safe and effective way to help reduce pain in pediatric sickle cell patients with pain crises~     in resource-limited settings.~   "
75883|NCT02573701|"~     The purpose of this study was to evaluate the applicability and usefulness of the guideline~     treatment for diagnosis and treatment of adolescents with schizophrenia, also to evaluate the~     compliance to the treatment according to the guidelines, and to compare the treatment~     compliance, severity of illness and social functioning of patients treated according to~     guideline treatment vs patients with the treatment as usual on a six month follow up.~   "
75884|NCT02573688|"~     The aim of the research study will be assess the effectiveness of a long-term~     interdisciplinary lifestyle in many aspects including food intake, psychological symptoms,~     physical activity habits, energy expenditure, body composition and anthropometric~     measurements in adults obese.~   "
75885|NCT02573675|"~     In this study, the recent trends in outcomes according to the dialysis modality in Korea~     since 2009, the effect of the use of peritoneal dialysis solutions containing icodextrin or~     high-glucose on various outcomes, the usefulness of 'PD first strategy', and the economic~     burden according to the dialysis modality will be investigated retrospectively using the~     Korean Health Insurance Review and Assessment Service (HIRA) database.~   "
75886|NCT02573662|"~     Introduction This study evaluates the effect on glucose, lipid and bone metabolism following~     knee orthopedic procedures in healthy and physically active individuals. The sedentary~     rehabilitation period following these procedures may impact negatively on glucose, lipid and~     bone metabolic pathways, whereas the more physically active rehabilitation period instituted~     6 weeks after surgery is hypothesized to impact positively.~      Perspective This study will establish whether the well-known effects on glucose, lipid and~     bone metabolism of a sedentary lifestyle can be observed already following 6 weeks of~     physical inactivity in otherwise healthy and physically fit young and middle aged~     individuals. Investigators will thereby add knowledge to previous findings following strict~     bed-rest in healthy individuals on glucose, lipid and bone metabolism. In a clinical~     perspective it is important to examine the extent to which healthy individuals deteriorate in~     various metabolic pathways to better understand the pathophysiology behind these defects both~     in healthy individuals and in patients, who undergo bed rest or an equal reduction in~     physical activity as part of their rehabilitation.~      Study design 16 physical active non-diabetic individuals of age 18 - 50 years who are~     undergoing knee surgical procedures at the Arthroscopic Center at Amager/Hvidovre Hospitals~     are recruited as cases for this case-control study.~      10 non-diabetic control subjects matched for age, gender and physical activity are recruited~     to establish a reference level.~        -  The individuals will bring in morning spot urine for measurement of soluble urokinase~          plasminogen activating receptor (suPAR), creatinine, albumin and orosomucoid. Weight and~          height and waist and hip circumference will be measured.~        -  Oral glucose tolerance test (OGTT) with ingestion of 75 g glucose during 5 min from~          baseline (0 min). Plasma for glucose, insulin, C-peptide, non-esterified fatty acid~          (NEFA) will be drawn~        -  Before OGTT blood will be drawn for measurement of HbA1c, total cholesterol, LDL, HDL,~          triglyceride, Na, K, creatinine, hemoglobin (HgB), C-reactive protein (CRP), leukocytes,~          alanintransaminase (ALAT), alkaline phosphatase, Ca++, D vitamin, TSH, bone turnover~          markers (BTM), suPAR, interleukin 6 (IL6), TNFa, high-sensitivity C-reactive protein~          (hsCRP), lipid density profiling and lipid particle size.~        -  Dual energy X-ray absorptiometry (DXA) of hip, lumbar columna, visceral and subcutaneous~          fat is measured by Hologic Discovery scanner.~   "
75887|NCT02573649|"~     Multicentre, prospective, double blinded, randomized study designed as an intrapatient~     comparison to evaluate the effects of the Biotronik Closed-loop Stimulation algorithm on~     prevalence and timing of haemodynamic variations and clinical prodromes induced by head-up~     tilt test in patients underwent pacemaker implantation for refractory cardioinhibitory~     vasovagal syncope.~   "
75888|NCT02573636|"~     The objective of the study is to evaluate the predictive value of TMPRSS2-ERG gene fusion and~     PTEN in patients with high risk prostate cancer treated with first line LHRH agonist after~     biochemical failure.~   "
75889|NCT02573623|"~     Diagnosis of tuberculosis (TB)in young children is a challenge due to atypical non-specific~     symptoms, difficulty to expectorate mucus, paucibacillary nature of pulmonary TB and low~     sensitivity of available diagnostic tools.~      This project aims at evaluating two innovative immunological methods for diagnosing of active~     TB among HIV-infected and uninfected children.~   "
75890|NCT02573610|"~     The purpose of this study is to evaluate superior efficacy of DE-108 ophthalmic solution to~     that of Levofloxacin 0.5% ophthalmic solution as well as safety of the former used for~     perioperative bacteria eradication in patients who are scheduled for cataract surgery.~   "
75891|NCT02573597|"~     Utilizing a 'minimal local analgesic concentration (MLAC) study' design to first determine~     the relative potency of Programmed Intermittent Epidural Bolus (PIEB) compared to Continuous~     Epidural Infusion (CEI) and secondly to determine the mechanism to explain the potential PIEB~     efficacy advantage.~   "
75892|NCT02573584|"~     The vascular fingerprint is a simple selection tool to identify testicular cancer patients~     with a high risk of arterial cardiovascular events during and in the first year after~     cisplatin chemotherapy. Eventually, this selection method allows a relative small randomized~     intervention study with i.e. LMWH during chemotherapy to prove the effectiveness and safety~     in lowering the chance of an arterial cardiovascular event.~   "
75893|NCT02573571|"~     To develop a score that can predict early from diagnosis of Clostridium difficile infection~     (CDI) the risk for relapse and of unfavorable outcome. This score can be used in the future~     to identify patients will benefit from fidaxomicin treatment.~   "
75894|NCT02573558|"~     Delirium are common after orthopedic surgery in the elderly and are directly associated with~     loss of independence, reduction in the quality of life and increased mortality. The cause of~     postoperative delirium still remains unclear and may be multifactorial. The aim of this~     retrospective study is to examine prevalence of postoperative delirium according to the use~     of dexmedetomidine or propofol in elderly patients undergoing orthopedic surgery under~     regional anesthesia.~   "
75895|NCT02573545|"~     To demonstrate that the use of Standard @IFE and Planning@IFE features of the IFE software,~     compared to the current method, when planning and inserting the needle under MRI monitoring~     in the context of liver biopsies enable:~        -  a facilitation of the planning stages of the procedure (route path, marking of the entry~          point and alignment of the MRI cutaways on the planned path), resulting in a reduction~          in the duration of the planning stages,~        -  a facilitation of the real-time modification of MRI cutaways during the procedure,~          resulting in a reduction of the duration of the procedure~   "
75896|NCT02573532|"~     This observational study includes patients undergoing major non-cardiac surgery, and screens~     them for the occurence of perioperative myocardial injuries (PMI). Incidence, patient~     characteristics, pathophysiology, and 1-year outcomes of PMI will be described.~   "
75897|NCT02573519|"~     Gastrointestinal (GI) symptoms including vomiting, nausea, abdominal pain, constipation or~     chronic diarrhea affect a large number of patients with diabetes mellitus (DM). Furthermore,~     abnormal GI transit times restrict correct dosing of medication. Two new methods, in~     combination only available at Aarhus University Hospital (AUH), allow examination of human~     whole-gut function with a high degree of detail:~      PET-scans (positron emission tomography scans) of cholinergic signaling in the bowel wall The~     most important nerve fibers stimulating GI peristalsis use acetylcholine as neurotransmitter.~     The novel PET technique, [11C] Donepezil PET/CT (Donepezil PET/CT scan based on a carbon~     isotope), developed at AUH, allows in vivo quantification of cholinergic cells within the~     bowel wall.~      3D-Transit With 3D-Transit electromagnetic capsules are followed during their passage through~     the GI tract. The novel method provides highly detailed information about regional and~     whole-gut passage times and contractility patterns.~      Study protocol 20 healthy subjects and 25 diabetic patients with severe GI symptoms will be~     included.~        1. With [11C]donepezil PET/CT, we aim to describe the degree of cholinergic denervation of~          the intestine in DM patients with GI severe symptoms.~        2. Using 3D-Transit in DM patients before and during intervention with acetyl~          cholinesterase inhibitor we aim to determine how cholinergic denervation of the~          intestine contributes to abnormal GI transit patterns.~        3. Comparing the transit times of DM patients with either vomiting or diarrhea as main~          symptoms, we aim to provide pilot data on phenotypes of diabetic GI dysfunction.~        4. We aim to explore various aspects of pan-enteric dysfunction in DM, including~          prolonged gastric emptying secondary to severe constipation and delayed small intestinal~          transit in patients with symptoms of gastroparesis with or without delayed gastric~          emptying~      Perspectives Detailed information about cholinergic denervation in DM and objective~     classification of the pathophysiology of diabetic GI dysfunction may allow targeted future~     treatment of individual patients.~   "
75898|NCT02573506|"~     This Phase II randomized study is to determine the efficacy of consolidation chemotherapy~     after split irradiation with concurrent chemotherapy in locally advanced none-small cell lung~     cancer patients with bulky tumor.~   "
75899|NCT02573493|"~     In this trial, the objectives are to determine the efficacy and toxicity of induction~     chemotherapy (IC) with nab-paclitaxel + cisplatin (Arm 1: AP) and with nab-paclitaxel (Arm 2:~     A) alone in patients with HNSCC, and to compare these data to nab-paclitaxel, cisplatin, and~     5-FU (APF). The investigators also hypothesize that the high anti-tumor efficacy of~     nab-paclitaxel in HNSCC is due to the upregulation of macropinocytosis, a result of the~     frequent presence of Ras and PI3K (and epidermal growth factor receptor -EGFR) activation in~     this cancer.~   "
75900|NCT02573480|"~     This study is an optimization study to evaluate how a wraparound program for youth who have~     been injured by violence helps to change violence related attitudes and beliefs, change~     individual risk factors for violence and reduce the risk of future injury due to violence.~     Wraparound care involves linking the youth with a support worker who will work with the youth~     to develop positive support networks and help them link with services that address risk~     factors towards future violence.~   "
75921|NCT02573207|"~     This study will collect clinical, echocardiographic, nuclear imaging and hemodynamic data in~     a group of patients with end stage ischemic cardiomyopathy undergoing left ventricular assist~     device (LVAD) implantation to investigate the incidence of recovery of myocardial function~     when supported with LVADs, and to study the association between hibernating myocardium and~     myocardial recovery in this population.~   "
75901|NCT02573467|"~     This extension study will provide data to further evaluate the efficacy, safety, and~     tolerability of three doses of BYM338 and to assess the long-term effects of BYM338 in~     patients with sporadic inclusion body myositis. The extension study was planned to consist of~     a Screening epoch (to assess patient eligibility), followed by a Treatment Period 1 epoch~     (double-blind and placebo-controlled), and a Treatment Period 2 epoch (open-label). A~     Post-treatment Follow-up (FUP) epoch was also planned for patients who discontinued~     prematurely. Patients who complete the core study and qualify for this extension study~     entered Treatment Period 1 and continued on the study drug to which they were randomized in~     the core study (either to one of the three bimagrumab doses (1 mg/kg, 3 mg/kg, and 10mg/kg)~     or placebo) during Treatment Period 1. Thus, Treatment Period 1 was double-blind and~     placebo-controlled. Participants were to continue in Treatment Period 1 until the dose with~     the best benefit-risk profile was determined from the core study data and selected (duration~     of Treatment Period 1 was estimated to be between 6 and 8 months). Once the dose with the~     best benefit-risk profile was selected, all participants (including those who were receiving~     placebo) were planned to enter Treatment Period 2 and switch to open-label treatment with~     bimagrumab at the selected dose. The core study has been completed but since the core study~     did not meet the primary end point (no bimagrumab dose was identified based on the core study~     efficacy results) the extension study was terminated as per protocol/sponsor's decision;~     therefore, no patients had entered Treatment Period 2. Instead, all patients were to return~     for the End of Treatment Period 1 (EOT1) visit at their next scheduled visit. As per~     protocol, all patients who discontinued study medication during Treatment Period 1 for any~     reason, including due to the study having been stopped as per protocol/sponsor's decision,~     were to have entered and complete the 6-month FUP after their EOT1 visit.~      Due to the nature of the design of the core and extension studies and termination of study~     medication in the extension study, the treatment duration for individual patients varied~     considerably. Consequently, the number of patients contributing data to the efficacy analyses~     at Week 104 and later timepoints was decreased.~   "
75902|NCT02573454|"~     The purpose of this study is to determine whether prosocial exercise (exercising for the~     benefit of others) results in greater well-being and physical activity when compared to~     personal exercise (exercising without attempting to benefit others). Participants will be~     randomly assigned to utilize one of two exercise apps for a two week period: Charity Miles,~     which allows users to donate money to charities based on exercise participation, or Nike+~     Running, which is a standard GPS exercise app. Participants will be provided with~     questionnaires at pre- and post-test, at a 4 week-follow-up, and immediately before and after~     each use of the app.~   "
75903|NCT02573441|"~     The study will examine whether school liaison services and home-based parental tutoring can~     help with academic difficulties of paediatric brain tumour survivors who received cranial~     spinal radiation and have returned to school. Forty-five patients will participate in the~     project. All patients will receive psychology liaison services to link resources at the~     hospital with those in the community. Patients will participate in one of two tutoring~     programs designed to directly or indirectly improve math skills over 12 weeks. Weekly phone~     calls will be used to support parents using the program. Patients will be tested before,~     immediately after, and six months following each tutoring program to assess growth in~     mathematics and working memory abilities.~   "
75904|NCT02573428|"~     The primary purpose of the present study is to evaluate the diagnostic validity of eye~     tracking measurements acquired during viewing of socially-relevant stimuli in predicting ASD~     diagnosis. The secondary purpose was to explore the potential prognostic value of eye~     tracking measures through cross-sectional associations with non-verbal cognitive ability.~      Deficits in eye gaze are a hallmark sign of autism. A large and growing body of research~     supports the ability of eye-tracking based measurements to sensitively discriminate~     individuals with ASD and healthy participants. These investigations have identified that the~     core deficit in autism as disruption of social attention, reflecting an inability to~     appropriately engage and track socially- and emotionally-relevant aspects of the visual~     world. Thus, eye gaze tracking, acquired during viewing of socially-relevant stimuli, may be~     a useful approach to identifying objective markers of ASD. Eye tracking also carries the~     advantages of being less intrusive and expensive than MRI and genetic testing and~     specifically focuses on the core neurobehavioral characteristics of ASD - abnormalities in~     social attention.~      After diagnosis of ASD, key clinical tasks in young children involve determining an accurate~     prognosis and tracking the progress of early interventions. Currently, the only prognostic~     indicators are clinical observations (subjective and expensive) and non-verbal cognitive~     ability testing (difficult to acquire, time-consuming, unavailable in many settings).~     Recently, eye gaze tracking was found to predict functional outcomes. Thus, in addition to~     being an objective marker for ASD, eye tracking measurements have potential to be useful for~     predicting cognitive and functional outcomes. Similarly, the only available methods for~     tracking treatment progress are parental reports (highly subjective), clinical observations~     (subjective and expensive), and cognitive measurements (expensive and unavailable in many~     settings. This study will evaluate, using cross-section data, the potential for eye tracking~     data to serve as a proxy for non-verbal cognitive ability scores in determining prognosis for~     ASD-affected children. Additionally, this study will evaluate the test re-test reliability of~     eye tracking parameters that can potentially be used to track treatment progress.~   "
75905|NCT02573415|"~     This feasibility study aims to enroll ten subjects who will undergo deceased donor uterine~     transplantation at Cleveland Clinic. We estimate that fifty to one hundred patients with~     uterine factor infertility will need to be screened to identify 10 appropriate subjects.~      There are seven phases involved in this study: Primary and Secondary Screening, Medical~     Evaluation, IVF, Transplantation, Embryo Transfer, Pregnancy/Delivery and Follow up~   "
75906|NCT02573402|"~     The purpose of this research study is to evaluate the effects upon the bladder of electric~     stimulation of the leg's tibial nerve in people with acute spinal cord injury with an~     intervention called transcutaneous tibial nerve stimulation (TTNS).~   "
75907|NCT02573389|"~     To determine whether pre-operative pancreatic stenting for distal pancreatectomy will impact~     the incidence of a post-operative pancreatic fistula, as defined by postoperative. If~     pre-operative pancreatic stenting appears to reduce the formation of Postoperative Pancreatic~     Fistula (POPF) in this pilot study, this will form the basis of a larger randomized trial in~     the future. The hypothesis is that pre-operative pancreatic duct stenting can significantly~     decrease the rate of development of a post-operative pancreatic fistula after distal~     pancreatectomy.~   "
75908|NCT02573376|"~     Approximately one half of all Americans living with Hepatitis C virus (HCV) are drug users,~     yet they are the least likely to receive HCV treatment. Drug users are presumed non-adherent~     and therefore denied potentially life-saving therapy. This assumption can only be confirmed~     or dispelled through prospective pharmacologic and adherence studies in this population. Such~     studies would be greatly enhanced by an objective, quantitative measure of adherence which~     does not currently exist in the HCV field. Through the work proposed in this application,~     sixty HIV/HCV co-infected drug users will be treated with direct acting antiviral agents~     (DAA) and randomized to receive directly observed DAA therapy (DOT) vs. no directly observed~     therapy (no-DOT). Patients randomized to no-DOT will have wirelessly observed therapy (WOT)~     which involves use of a portable medication dispenser that sends a signal to a server with~     the date and time when the dispenser is opened. In Aim 1, DAA concentrations will be compared~     in those randomized to DOT vs. no-DOT. DAA pharmacokinetics will also be defined accounting~     for clinical factors like degree of hepatic impairment and use of concomitant recreational~     and antiretroviral drugs. The goal is to quantify adherence in this population and the effect~     of variable adherence on drug concentrations. In Aim 2, DAA concentrations (plasma, cellular,~     hair) will be linked with adherence patterns identified using WOT and DOT. The goal is to~     identify a drug concentration biomarker that predicts adherence in this population. In Aim 3,~     the relationship between DAA adherence (as measured by WOT and DOT and drug concentrations)~     and rate of cure will be established. The goal is to define the degree of adherence needed~     for HCV cure.~   "
75909|NCT02573363|"~     This phase I trial studies the side effects and the best dose of selinexor when give together~     with standard chemotherapy, high dose cytarabine and mitoxantrone hydrochloride, in treating~     patients with acute myeloid leukemia. Selinexor may stop the growth of cancer cells by~     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as~     cytarabine and mitoxantrone hydrochloride, work in different ways to stop the growth of~     cancer cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Giving selinexor together with standard chemotherapy may be a better~     treatment for patients with acute myeloid leukemia.~   "
75910|NCT02573350|"~     A phase 2, multicenter, uncontrolled, open-label trial in patients with MDR-TB. Only patients~     who completed Trial 204 were eligible. The trial was performed globally at 14 sites qualified~     to treat MDR-TB. All 434 patients who completed Trial 204 were eligible for this trial if~     there was still potential clinical benefit to them and all inclusion criteria and no~     exclusion criteria were met.~   "
75911|NCT02573337|"~     The purpose of this study is to evaluate the perception of facial expressions following~     correction of wrinkles and folds in the lower face using Emervel Classic Lidocaine and~     Emervel Deep Lidocaine.~   "
75912|NCT02573324|"~     This study seeks to determine whether the addition of ABT-414 to concomitant radiotherapy and~     temozolomide (TMZ) followed by combination of ABT-414 with adjuvant TMZ prolongs overall~     survival (OS) among participants with newly diagnosed glioblastoma (GBM) with epidermal~     growth factor receptor (EGFR) amplification.~      In addition, there is a Phase 1, open-label, multicenter sub-study to assess the~     pharmacokinetics, safety and tolerability of ABT-414 in participants with newly diagnosed~     EGFR-amplified GBM who have mild or moderate hepatic impairment.~   "
75913|NCT02573311|"~     An actual use study to assess how men who respond to advertisements about urinary symptoms~     use tamsulosin in a simulated Over the Counter (OTC) setting including following stop use~     and ask a doctor if and ask a doctor before use statements and if they take the medication~     according to the label instructions, also assess any reported adverse events during simulated~     OTC use.~   "
75914|NCT02573298|"~     The primary aim of the study is to evaluate the effects of two local cryotherapy (ice or cold~     gas) applications on arthritic knees.~      Evaluation criteria (before/after treatment):~        -  synovial power-Doppler semi-quantitative score~        -  pain VAS (mm)~        -  cytokine levels in synovial fluid~        -  leukocyte count in synovial fluid~   "
75915|NCT02573285|"~     The objective of this multi-center, non-randomized, prospective pilot study is to examine the~     rate of successful primary spontaneous pneumothorax (PSP) resolution using the simple~     aspiration technique.~      In this study, eligible subjects diagnosed with PSP at eleven participating large children's~     hospitals (members of the Midwest Pediatric Surgical Clinical Research Consortium) will be~     enrolled and offered a choice of management with either the simple aspiration protocol or~     management according to their surgeon's preference, which may include simple aspiration,~     chest tube placement, or rarely, an operation.~   "
75916|NCT02573272|"~     Knowing the impact that the use of ESL as adjunctive treatment of partial epilepsy has on~     cardiovascular risk factors measured by biochemical and ultrasound parameters compared with~     enzyme-inducing AEDs.~   "
75917|NCT02573259|"~     Protocol B8011001 is a Phase 1, open-label, multi-center, multiple-dose, dose escalation and~     expansion, safety, pharmacokinetics (PK), and pharmacodynamics (PD) study of PF-06801591 in~     previously treated adult patients with locally advanced or metastatic melanoma, SCCHN,~     ovarian carcinoma, sarcoma, NSCLC, urothelial carcinoma or other solid tumors. This is a 2~     Part study whereby the safety and tolerability of increasing dose levels of intravenous (IV)~     or subcutaneous (SC) PF-06801591 was assessed in Part 1. Part 2 expansion is designed to~     further evaluate the safety and efficacy of SC PF-06801591 in patients with NSCLC or~     urothelial carcinoma as well as confirm the recommended Phase 2 dose.~   "
75918|NCT02573246|"~     Psychological treatments are effective, but take a long time and can be burdensome.~     Therefore, avenues to optimize behavioral treatments are needed. Despite important~     advancements, neuroscience has had a limited effect on psychotherapy development. Therefore,~     one paradigm shift would be to develop neuroscience informed behavioral treatments.~      The investigators identified from the literature a problem that affects several mental~     disorders (emotion dysregulation) and a neural circuit that underlies this important concern.~     They found that this circuit is dysfunctional in those with psychopathology but can be~     changed with treatment. The goal is in one session to train this brain network to operate~     more efficiently and to test the short and long term effects of this intervention. The~     investigators plan to engage this brain network using a traditional psychotherapy strategy~     (cognitive restructuring) and to enhance learning using repetitive transcranial magnetic~     stimulation (rTMS), a neuromodulation technique through which magnetic stimulation enhances~     the electrical activity in brain areas close to the scalp.~      The study team proposes to include 105 participants divided into 3 groups. All participants~     will be trained in emotion regulation by first being asked to remember an event where they~     experienced a negative emotion and then being instructed either to think differently about~     the event, or to wait. Participants will simultaneously undergo either real (left or right~     side of brain) or sham rTMS. The investigators will measure their regulation in the lab and~     during a-week long naturalistic assessment. Participants will return to rate feasibility,~     acceptability, and to provide feedback. If successful, this proof of concept study can open~     new frontiers for neuroscience informed treatment development. 40 of the 105 participants~     will be called back for a brain imaging session where the ideal target for neurostimulation~     is identified with the use of an emotion regulation paradigm.~   "
75919|NCT02573233|"~     Primary Objective:~      To evaluate the effect of dupilumab, compared to placebo, on airway inflammation in patients~     with persistent asthma.~      Secondary Objective:~      To assess the safety, tolerability, and immunogenicity of dupilumab compared to placebo.~   "
75920|NCT02573220|"~     This phase I trial studies the side effects and the best dose of irinotecan hydrochloride,~     based on a genetic test, when given in combination with fluorouracil, leucovorin calcium, and~     cetuximab as first-line therapy in treating patients with an abnormal gene called RAS~     wild-type that has spread to other parts of the body (metastatic). Patients may also have a~     gene called uridine diphosphate glucuronosyltransferase (UGT1A1) that may interfere with the~     way irinotecan hydrochloride is absorbed by the body and may not be able to tolerate it.~     Determining the presence of this gene may help determine the best dose of irinotecan~     hydrochloride when given with fluorouracil and leucovorin calcium (FOLFIRI). Combination~     chemotherapy, such as FOLFIRI, works in different ways to stop the growth of tumor cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Cetuximab may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Giving FOLFIRI together with cetuximab may be a better treatment for~     patients with colorectal cancer.~   "
75922|NCT02573194|"~     Over the last decades, changes in the diet and lifestyle have led to overall energy imbalance~     becoming commonplace and the emergence of an obesity epidemic with more than 1.6 billion~     adults being overweight.~      Consumption of foods that can affect appetite by increasing satiety could regulate the total~     energy intake and thus body weight. There is data suggesting that the macronutrient~     composition of the foods and especially protein content may have a potent role on satiety.~     However, the type of protein appears to play a role in satiety possibly due to the different~     balance of the amino acid profile.~      The research project is dedicated to identify the source (animal or plant) and the optimized~     protein quantity needed to accelerate satiation, suppress appetite and extend satiety until~     hunger appears again.~      It is hypothesized that the consumption of animal derived protein-enriched meals will induce~     a reduction in hunger through the impact on gut hormones and peptides that are closely~     related to the short-term regulation of food intake.~   "
75923|NCT02573181|"~     This study is designed to assess the safety, tolerability, and immunogenicity of V114~     compared with Prevnar 13™ in healthy adults 65 years of age or older previously vaccinated~     with 23-valent pneumococcal polysaccharide vaccine.~   "
75924|NCT02573168|"~     Evidence exists supporting the ability of genetic variations to influence patient drug~     response and side effects. To-date, no RCT has been conducted to evaluate the outcomes in~     schizophrenia/schizoaffective disorder patients following the use of pharmacogenomic guidance~     of treatment selections. The first objective of this trial is to utilize a double-blinded,~     randomized clinical trial design to evaluate the clinical outcomes in participants treated~     with the benefit of GeneSight Psychotropic (GEN) test. Another objective is to determine the~     added benefit of Enhanced-GeneSight (E-GEN) compared to GEN for the pharmacogenomic guidance~     of treatment selections. Furthermore, this trial intends to develop an evidence-based case~     for the value of GEN and E-GEN to Canadian healthcare payers.~   "
75925|NCT02573155|"~     This is a phase I, randomised, placebo-controlled 2-part study to assess the safety,~     tolerability, pharmacokinetics and pharmacodynamics of AZD8871 delivered by inhalation, in~     asthmatic and chronic obstructive pulmonary disease (COPD) subjects.~   "
75926|NCT02573142|"~     The primary aim of this study is to reduce body mass index (BMI) among children ages 5-11 who~     are obese by integrating behavioral treatment strategies in both clinic (Healthy Lifestyles)~     and community (Bull City Fit) settings. A two-group randomized, controlled, non-blinded pilot~     design will be utilized. The intended target population is the adult caregiver and a child~     with obesity (BMI ≥ 95th percentile) aged 5-11. The intervention condition will be standard~     care with Healthy Lifestyles programming plus Bull City Fit; upcoming activities will be~     texted to the parents mobile device using GoogleVoice. The control condition will be standard~     clinical care with Healthy Lifestyles programming. Primary outcome is BMI at 6 months.~     Secondary outcomes include anthropometric, psychosocial, and reported health behaviors.~   "
75927|NCT02573129|"~     The purpose of the proposed research study is to assess the effects of including greater~     amounts of minimally processed red meat (lean pork and beef) into a Mediterranean Diet on~     cardiometabolic and emotional well-being.~   "
75928|NCT02573116|"~     Evaluation of the add-on effect on endothelial dysfunction of treatment of periodontitis in~     patients with chronic periodontitis and severe obstructive sleep apnea treated by CPAP.~     Patients with and without chronic periodontitis will be treated by CPAP for 20 weeks. At V2~     (10 weeks), endothelial dysfunction will be assessed by the Reactive Hyperemia- Peripheral~     Artery Tone index. The endothelial dysfunction of the patients will be also assessed at V3~     (20 weeks) after periodontitis treatment for the group of patients with chronic~     periodontitis.~   "
75929|NCT02573103|"~     To determine the effects of ambient airpollution exposures on lipid metabolism among healthy~     adults without cardiovascular disease.~   "
75930|NCT02573090|"~     The research project SEAL-DK is focusing on advantages and disadvantages of two treatment~     strategies: non-invasive fissure sealing and invasive restorative treatment of manifest~     occlusal caries lesions in permanent teeth in children and adolescents. The purpose of the~     project is to promote the understanding of the possibilities of non-invasive treatment of~     occlusal caries lesions in the permanent dentition, and to increase the present knowledge~     about the optimal threshold for sealing or restoration, respectively, when treating such~     lesions.~      The project is carried out as a randomized study of the two treatment strategies:~     non-invasive versus invasive treatment of occlusal caries. When organizing the study, it is~     emphasized that no treatment shall be carried out, if conflicting the participating dentists'~     perception of clinically proper caries treatment, and that the results shall have a high~     reliability and consistency.~      The hypothesis is that caries progression can be stopped by non-invasive fissure sealing~     changing the threshold and postponing the time for invasive restoration.~   "
75931|NCT02573077|"~     This observational, prospective, non-interventional study will include cancer patients who~     need a treatment for hyponatraemia secondary to SIADH. Patients will be prescribed~     treatment(s) according with the clinical practice regardless of the patient participation in~     the study. The purpose of this NIS is to collect additional scientific and clinical~     information that can help in describing the characteristics of cancer patients with~     hyponatraemia secondary to SIADH, the current management of hyponatremia, the therapies to~     keep under control serum [Na+] and the guidelines for the management of this population in~     Italy.~   "
75932|NCT02573064|"~     The present study was designed to study the impact of empirical treatment with colistin~     empirical monotherapy and combined treatment with tigecycline and vancomycin on mortality of~     bacteremia Multiresistant Acinetobacter Baumannii . The main objective was to evaluate the~     efficacy of empirical treatment with colistin and combined targeted therapy. The different~     therapeutical interventions were administered following the routine clinical practice in the~     medical centre and the investigator did not assign specific interventions to the subjects of~     the study.~   "
75957|NCT02572739|"~     Thermodilution cardiac output measurement is a reliable method, but it is an invasive one.~     PiCCO device requires cannulation of central vein and peripheral artery. Impedance method~     requires only attachment of special electrodes. Non-invasive methods are less accurate. Aim~     of study is to assess accuracy and reliability of impedance method ( using NICCOMO device) in~     comparison of thermodilution method ( using PiCCO device) at different PEEP levels.~   "
75933|NCT02573051|"~     Anembryonic pregnancy is a leading cause of early miscarriage. The American Pregnancy~     Association estimates that blighted ovum causes approximately 50 percent of all~     first-trimester miscarriages. About 20 percent of all pregnancies result in miscarriage.~      In general, there are 3 options for management of anembryonic pregnancy: expectant, medical,~     and surgical management. Expectant management consists of no intervention and awaiting~     natural passage of tissue. Medical management uses medication to expel uterine tissue.~     Surgical management is defined by mechanical removal of tissue from the uterus.~      Medical management allows patients to avoid surgery and anesthesia. Patients may also feel~     that medical management is more private, and under their control. Several medications have~     been studied for medical management.~      Misoprostol, a prostaglandin E1 analogue, is a uterotonic that results in cervical softening~     and contractions that expel the products of conception. It may be administered vaginally,~     orally, buccally, or sublingually. Adverse effects vary based on route of administration.~      There is published literature on a wide range of therapeutic misoprostol regimens. Optimal~     dose and route of administration of misoprostol have not been determined by randomized~     trials. Overall, misoprostol is safe and well-tolerated.~      Patients receiving misoprostol vaginally rather than orally have decreased adverse~     gastrointestinal effects and prolonged duration of action.~      Oral misoprostol is less effective than vaginal misoprostol in emptying the uterus.~     Sublingual misoprostol is equivalent to vaginal misoprostol in inducing complete uterine~     emptying but is associated with more frequent diarrhea.~      When compared with lower dosages, a dose of 800 µg vaginal misoprostol is more effective at~     completing uterine emptying, although it results in a similar incidence of nausea. Based on~     international trials in settings with limited resources, WHO recommends a single vaginal dose~     of 800 µg misoprostol for medical management of anembryonic pregnancy. Routes of misoprostol~     administration include oral, vaginal, buccal or rectal. Vaginal misoprostol is associated~     with a greater overall exposure to the drug and greater effects on the cervix and uterus.~      Isosorbide mononitrate (IMN) is a drug used principally in the treatment of angina pectoris,~     which acts by dilating the blood vessels so as to reduce blood pressure.~   "
75934|NCT02573038|"~     Angioid streaks are rare lesions associated to retinal pigment epithelium degenerations.~      They can be caused by general diseases as pseudoxanthoma elasticum, Paget's disease or~     drepanocytosis. Choroidal neovascularization (CNV) represents the most frequent complication~     for those patients. It leads to a rapid and important loss of visual acuity. CNV in angioid~     streaks represent the fourth leading cause of CNV in young patients.~      CNV in angioid streaks is treated at the moment with off-label anti-VEGF (Vascular~     Endothelial Growth Factor) therapy and could also benefit from aflibercept (EYLEA), a new~     anti-VEGF currently indicated in AMD. Case reports suggest that such patients would not need~     as many injections as in AMD.~      ASTRID is an open-label, single arm, prospective, multicenter, phase II study. The main~     objective is to demonstrate the effectiveness in clinical terms after 52 weeks of treatment~     with aflibercept on the visual acuity of patients affected by CNV in angioid streaks. A~     specific dosage regimen is designed to achieve maximum efficiency. The patients are followed~     on a monthly basis until 52 weeks. Six injections are mandatory, the other ones are injected~     only in case of active CNV.~   "
75935|NCT02573025|"~     This is an open-label, randomized, multi-center, single dose, two-period, two-sequence~     crossover study to investigate the bioequivalence of PEG-IFN alfa-2a BA-free formulation~     versus the reference market formulation (PEG-IFN alfa-2a [Pegasys®]) following subcutaneous~     administration via prefilled syringe in healthy Chinese participants.~   "
75936|NCT02573012|"~     This Phase IIIb/IV, two-arm, randomized, double-blind, placebo-controlled, parallel-group,~     international, multicenter trial compares the change in disease activity (as assessed by~     Disease Activity Score in 28 joints [DAS28] erythrocyte sedimentation rate [ESR]) from~     randomization to Week 24 post-randomization, in participants with stable low disease activity~     [LDA] (DAS28 ESR score less than or equal to [<=] 3.2) who receive tocilizumab, and have been~     randomized to either continue or taper prednisone in a double-blinded fashion.~   "
75937|NCT02572999|"~     This prospective cohort study aims to determine the incidence of hospitalization-associated~     disability and its association with risk factors at the patient level and with care and~     hospital processes. For this, patients aged 70 years or older admitted for elective valve~     surgery or elective transcatheter aortic valve implantation or as a result of symptomatic~     moderate to severe valvular heart disease will be consecutively included from 01 October 2015~     to 29 February 2016.~   "
75938|NCT02572986|"~     Scabies is an infestation of the skin by the human itch mite (Sarcoptes scabiei). Diagnosis~     of scabies is made based on clinical symptoms, such as nocturnal itching, and appearance and~     distribution of the rash. Definitive diagnosis includes the microscopic identification of the~     mite, mite eggs, or mite fecal matter in the skin. Topical permethrin is considered the drug~     of choice for the treatment of scabies. It is a synthetic pyrethroid that is safe for use in~     adults and children 2 months and older.~      This study will evaluate the therapeutic equivalence of a generic permethrin cream 5% to~     Elimite® in the Treatment of Scabies.~   "
75939|NCT02572973|"~     The acoustic neuromodulation trial (ANM-T) is a two-phase, single-site, pilot randomized~     clinical trial examining the feasibility of completing a larger scale efficacy study of a~     novel treatment of non-linear modulated acoustic stimuli to reduce anxiety severity in youth~     with anxiety disorders. The primary objective is to establish the feasibility of a blinded~     randomized controlled trial of ANM for childhood anxiety disorders.~   "
75940|NCT02572960|"~     To investigate possible physiologic interactions between the adrenal- and the parathyroid~     glands in patients with secondary hyperparathyroidism.~   "
75941|NCT02572947|"~     Current HIV treatment guidelines recommend a combination of drugs for the maintenance of~     antiretroviral therapy (ART). Simplification is considered critical to further scale-up of~     treatment, to support retention in care and to reduce costs. Dolutegravir is a once daily~     integrase inhibitor that shows very good tolerability, efficacy, and distinctive resistance~     profile. The researchers aim at investigating the feasibility of dolutegravir monotherapy in~     maintenance therapy. Briefly, 10 virologically suppressed patients for at least six months on~     conventional triple ART of dolutegravir plus two nucleoside reverse transcriptase inhibitors~     (NRTIs) will be switched to dolutegravir monotherapy for 24 weeks. The primary endpoint is~     the number of patients completing 24 weeks of dolutegravir monotherapy without experiencing~     virological failure.~   "
75967|NCT02572609|"~     to evaluate the bioavailability of ambroxol hydrochloride soft pastilles (test formulation),~     manufactured by Bolder Arzneimittel GmbH & Co. KG to Boehringer Ingelheim compared to~     ambroxol hydrochloride syrup (Mucosolvan® adult syrup), manufactured by Boehringer Ingelheim~     do Brasil Química e Farmacêutica Ltda.~   "
75968|NCT02572596|"~     Comparing intermediate-dose CTX (ID-CTX)and G-CSF with rhTPO or without for peripheral blood~     stem cell mobilization in patients with multiple myeloma, try to find out whether rhTPO~     combined to ID-CTX + G-CSF could improve the results of peripheral blood stem cell~     mobilization.~   "
77624|NCT02550951|"~     Its usefulness in implementing magnetic resonance angiography for postoperative follow-up of~     lymph lymphedema should try to evaluate and compare lymphoscintigraphy.~   "
75942|NCT02572934|"~     Depending on disease stage, testicular cancer (TC) treatment consists of an orchidectomy,~     alone or followed by radiotherapy (RT) or platinum-based chemotherapy (CT). TC survival rates~     are above 90% nowadays, which results in growing TC survivor population. Because of the long~     life expectancy of these survivors, prevention or early detection of late treatment effects~     has become increasingly relevant. Yet known late effects are nephrotoxicity, cardiovascular~     disease (CVD), secondary malignant neoplasms (SMN), neurotoxicity, pulmonary toxicity,~     Raynaud's phenomenon, hypogonadism, fatigue and psychosocial problems. Nephrotoxicity is an~     important late effect, but data is lacking in very long-term survivors since performed~     studies have a follow-up duration of 5-14 years. Decreased renal function is a known risk~     factor for CVD development and also an association between renal function and neurtoxicity~     via circulating platinum levels has been shown. It is hypothesized that treatment induced~     nephrotoxicity is prevalent in TC survivors and might be a mediator for development of late~     effects. The secondary aim is to assess prevalence of late effects in very long-term TC~     survivors: until now, most data have been collected through questionnaires in large~     epidemiological studies in TC survivors till approximately 10 years after treatment. The~     prevalence of late effects may increase over time: 10 years after treatment late effects may~     not be present yet, whilst late effects can emerge just after 20 years. Consequently, health~     status and possible late effects, resulting in morbidity, are underestimated in patients who~     are 20-30 years after treatment. By investigating health status of these very long-term~     survivors a more profound insight in the prevalence and aetiology of these late effects and~     the development over time can be assessed. Current treatment is very similar to TC treatment~     20-30 years ago and therefore knowledge on late effects is relevant for currently treated~     patients. Furthermore, as a result of this study, we will better understand which factors and~     issues should be watched closely during follow-up, which TC survivors are at increased risk~     of developing late treatment effects and how to detect early damage before overt morbidity~     occurs.~   "
75943|NCT02572921|"~     This study evaluates the effects of the Positive Psychotherapy on depressive symptoms and on~     happiness compared with regular cognitive behavioral therapy.~   "
75944|NCT02572908|"~     This is randomized pilot study comparing tolerability of yeast-baked wheat bread and~     sourdough wheat bread in irritable bowel syndrome.~   "
75945|NCT02572895|"~     The purpose of this clinical trial study is to assess, among young and sexually active women~     presenting recurrent urinary tract infection (UTIs), efficacy of an optimal dose of cranberry~     extract quantified and standardized to 37 mg/day of Proanthocyanidins (PACs), compared to a~     control dose quantified and standardized to 2 mg/day of PACs on mean number of new UTIs~     during a 6-month follow-up period.~   "
75946|NCT02572882|"~     The Microbiome trial is a non-randomized, open-label, crossover, multi-center study of~     p-inulin for patients with hemodialysis-dependent end-stage renal disease.~   "
75947|NCT02572869|"~     The purpose of this study is to assess the functional and esthetic outcomes in patients who~     had removal of a part of the lower jaw bone due to mouth cancer and reconstruction of the jaw~     bone with a bone ( fibula) from the leg at MSKCC between the years 1987 to 2014.~   "
75948|NCT02572856|"~     During surgery and after surgery elevated blood glucose levels can lead to poor outcome such~     as wound infections. Current technology does not allow close monitoring of glucose levels~     often resulting in poor management of glucose levels. In this study, the investigators will~     evaluate the feasibility of using a continuous glucose monitor (Dexcom Gen 6 Professional)~     during and after surgery. Such a monitor has the potential of monitoring glucose levels~     continuously and in real-time, thus allowing better glucose management~   "
75949|NCT02572843|"~     The objective of the trial is to demonstrate that the addition of neoadjuvant and adjuvant~     immunotherapy (with the anti-PD-L1 antibody MEDI4736) to standard neoadjuvant chemotherapy~     (with cisplatin/docetaxel) in primary resectable stage IIIA(N2) NSCLC is efficacious and~     feasible.~   "
75950|NCT02572830|"~     Blocking of reconsolidation by pharmacological or behavioral means offers the therapeutic~     possibility of weakening traumatic memories in posttraumatic stress disorder (PTSD). Two~     reconsolidation-based interventions, propranolol and extinction learning, have been shown to~     weaken fear memories in human healthy subjects. However, the success of these interventions~     seems to be limited to weak conditioned fear memories. This calls for new, potentially more~     efficacious, interventions to be tested. Bilateral eye movements seem to be a promising~     candidate intervention for blocking reconsolidation due to the compelling evidence of Eye~     Movement Desensitization and Reprocessing as effective treatment in PTSD. The investigators'~     aim is to test bilateral eye movements as an active reconsolidation-blocking intervention in~     an optimized differential fear conditioning procedure that the investigators have recently~     developed. This novel experimental assay creates stronger fear memories in healthy~     individuals.~   "
75951|NCT02572817|"~     This study will assess the efficacy and safety of anti-influenza immune plasma, as an~     addition to standard of care antivirals, in participants hospitalized with severe influenza A~     infection.~   "
75952|NCT02572804|"~     This is a prospective randomised controlled trial that will compare the outcomes of rectus~     sheath catheters to epidurals in patients who have undergone a cystectomy, via a lower~     midline abdominal incision for bladder cancer.~   "
75953|NCT02572791|"~     The investigators propose a pragmatic comparative effectiveness trial evaluating several~     decolonization strategies in patients with Staphylococcus aureus infection, their household~     contacts, and household environmental surfaces. The central hypothesis of this proposal is~     that an integrated approach of periodic personal and household environmental hygiene will~     reduce S. aureus transmission in households and subsequently decrease the incidence of skin~     and soft tissue infections (SSTI).~   "
75954|NCT02572778|"~     The investigators want to have a collection of fresh primary or recurrent tumor tissue for~     establishment of patients-derived xenografts in order to:~      generate a biobank of in vivo patient xenografts representing the different subgroups of~     tumors for head and neck cancer~        -  perform genetic and transcriptional profiling of the primary, metastatic tumors and~          xenograft tumors~        -  evaluate the efficacy of new targeted agents, whether or not in combination with~          standard treatment options~        -  evaluate biomarkers of drug sensitivity~        -  study primary and secondary (acquired) resistance in these models~   "
75955|NCT02572765|"~     The purpose of this study is to evaluate the splenic activation in hypertensive patients, as~     compared to normotensives, using FDG-PET/CT imaging. Moreover, the investigators will~     investigate whether the splenic metabolic activity relates to the expression of circulating~     inflammatory proteins (high-sensitivity C-reactive protein [hsCRP]), interleukin-1b (IL-1b),~     tumor necrosis factor-a (TNF-a) or to immune profiles of activated T cells.~   "
75956|NCT02572752|"~     To establish the bioequivalence of 1 soft gelatine capsule containing 200 mg nintedanib~     compared to 2 soft gelatine capsules containing 100 mg nintedanib~   "
77625|NCT02550938|"~     To demonstrate that a primer aligner product can achieve similar results to the currently~     marketed product.~   "
75958|NCT02572726|"~     Transcranial magnetic stimulation (TMS) is a neurophysiological tool for studying cortical~     functions, and in addition, has an analgesic therapeutic effect whose underlying mechanism is~     unknown. The proposed research will use TMS in conjunction with brain imaging and~     electrophysiology to examine cortical plasticity and connectivity modifications induced by~     repetitive TMS (rTMS) targeted to affect cortical regions associated with endogenous~     analgesia (EA). This will be carried out in both healthy and chronic pain (fibromyalgia)~     states. rTMS analgesic intervention, targeted to the motor cortex (M1) will be preceded and~     followed by structural and functional magnetic resonance imaging (fMRI), and Diffusion Tensor~     Imaging (DTI). This will be done in order to examine alterations of cortical and brainstem~     mechanisms involved in EA and to investigate connectivity changes between cortical and~     sub-cortical regions of the EA networks. The latter as well as EA efficiency and pain-related~     personality variables will be used to assess individual differences in neuroplasticity within~     the EA systems in both healthy subjects and chronic pain patients.~   "
75959|NCT02572713|"~     The purpose of this study is to measure alpha-synuclein in peripheral body tissues and fluids~     in Parkinson's disease (PD). This may help in developing better treatments for PD patients in~     the future.~   "
75960|NCT02572700|"~     The objective of the study is to investigate pain mechanisms, ultrasonographic (US)~     inflammatory activity and association between these conditions in patients with psoriatic~     arthritis (PsA) intensifying anti-rheumatic treatment. Further, to assess the predictive~     value of baseline pain profile and US joint/entheses activity on treatment outcome after 4~     months.~   "
75961|NCT02572687|"~     The main purpose of this study is to evaluate the safety of ramucirumab plus MEDI4736 in~     participants with locally advanced and unresectable or metastatic gastrointestinal or~     thoracic malignancies including gastric or gastroesophageal junction (GEJ) adenocarcinoma,~     non-small cell lung cancer (NSCLC), or hepatocellular carcinoma (HCC).~   "
75962|NCT02572674|"~     Study in 400 patients with bipolar disorder I or II, of relapse risk factors. The principal~     objective of this research is to test the predictive value of core vulnerability dimensions~     such as affective instability and emotional reactivity, measured by validated questionnaires~     (AIM and ALS) on recurrence of affective major episode (depressed, hypomanic or manic) during~     a 24 months prospective follow-up.~      In addition, several arguments suggest that inter-individual variability in the risk of~     relapse is influenced by genetic factors. In particular, the implication of such factors have~     been demonstrated in rapid cycling or antidepressants induced mania. However, this has never~     been tested in cohorts followed prospectively. Finally, the existence of neuropsychological~     deficits in bipolar disorder is well documented and their role in the risk of relapse is~     suspected. Yet the nature of these deficits, their origin and evolutionary course remain~     poorly investigated. In summary, the secondary objectives of this research are the study of~     the influence of these other clinical, neuropsychological and genetic factors on the risk of~     relapse.~      • Scientific rationale The dimensions of affective instability and emotional reactivity, are~     considered core psychological and temperamental vulnerability dimensions to bipolar disorder.~     Differences in levels of instability and reactivity may account for the inter-individual~     variability observed in bipolar disorder in terms of risk of relapse. These dimensions are~     measured using validated questionnaires (Affective Instability Measure (AIM) and Affective~     Lability Scale (ALS)). Relapsing is defined as the occurrence of a depressive episode,~     hypomanic, manic or mixed episode (DSMIV criteria).~      Other factors that may influence the risk of relapse have been suggested in the literature~     but have not been formally tested in prospective studies:~        1. cognitive deficits: the existence of neuropsychological deficits in bipolar disorder are~          well documented and their role in the risk of relapse is suspected. Yet the nature of~          these deficits, their origin and their course remain poorly investigated. Indeed, some~          appear to be related to the neurotoxicity of the episodes themselves, the other being~          related to the vulnerability to bipolar disorder~        2. The involvement of genetic vulnerability factors in bipolar disorder is widely~          demonstrated. Several arguments suggest the implication of genetic factors in the risk~          of relapse. This is the case for some outcome patterns such as rapid cycling or~          antidepressants induced mania. Again, this has never been tested in cohorts followed~          prospectively.~        3. The role of certain inflammatory and infectious factors in the etiology of bipolar~          disorder has been suggested but it is clear whether these biomarkers are state or~          traits. Thus, the role of neurotoxic inflammatory or infectious factors in relapse~          mood has never been tested in a prospective follow up studies.~             -  Main objective of the project To determine if the scores of AIM and ALS, assessed~               at baseline in euthymic bipolar patients is associated with relapse in patients~               during a 2 years follow-up period.~             -  Secondary objectives of the project Determine if the neuropsychological performance~               at T0, measured in euthymic patients predict relapse during a 2 years follow-up~               period.~      Determine whether the neuropsychological deficits observed in euthymic bipolar patients that~     contribute to functional impairment worsen with time.~      DNA collection to test the involvement of candidate genes Serum collection to study the~     biological and infectious biomarkers~      • Methodology Prospective follow up studies. Multicenter.~   "
75963|NCT02572661|"~     This study aims to explore the feasibility, safety and outcome of a non‐invasive sentinel~     node mapping (SNM) to individually tailor the elective nodal irradiation (ENI) to the~     ipsilateral neck only and to exclude the contralateral negative neck from the irradiation~     fields when there is no draining sentinel node. Subsequently the dose to the salivary glands,~     mucosal area and the swallowing and chewing muscles and structures involved in voicing and~     articulation will significantly be reduced~   "
75964|NCT02572648|"~     The purpose of this study is to examine the relation between the structural brain changes~     associated with heart failure, neurocognitive performance, and how these changes impact~     self-care behaviors.~   "
75965|NCT02572635|"~     Streptococcus pneumoniae is a type of bacteria that can cause infections of the ears, sinuses~     or lungs. It can also cause more serious infections of the blood or brain. The elderly and~     young children are more vulnerable to these types of infections.~      The vaccines available at present are effective only on a certain number of strains of the~     bacteria. The PnuBioVax vaccine is being developed to work on a broader range of strains.~     This study will be looking at the safety and tolerability of the study drug for three~     different dosages: 50 μg, 200 μg, and 500 μg compared to placebo.~      The population eligible to take part in the study are healthy male and female subjects~     between 18 and 40 years of age.~      Volunteers for the study will be recruited through advertisements. Each volunteer will have~     received an information sheet concerning the study and will have agreed to participate in~     writing. Volunteers will be given at least 48 hours between reading the information leaflet~     and agreeing to participate. Only subjects who agree to undertake precautions to avoid~     pregnancy of either themselves of their partner during the study period will be eligible.~     Volunteers will give signed consent for their physician to be notified about their~     participation in the trial.~   "
75966|NCT02572622|"~     The aim of this study is to determine the effectiveness of three different treatment methods~     which consists spinal decompression, deep friction massage and exercise. The patients were~     separated three groups Group one received non-surgical spinal decompression therapy, group~     two received non-surgical spinal decompression, lumbar stabilization exercises and manual~     therapy, group three received manual therapy and lumbar stabilization exercises. All groups~     completed 15 sessions of therapy. In each session, pain severity was assessed with numeric~     analog scale, straight leg raise test applied and the degree of the hip flexion where the~     patient reported pain were recorded, respectively. Static, dynamic muscle strength-endurance~     tests were applied before the treatment sessions started, after the treatment sessions ended,~     six weeks after and three months after the study. Oswestry Disability Scale (ODI), Back~     Performance Scale (BPS), Lanss Neuropathic pain Questionnaire, Fear-Avoidance-Beliefs~     Questionnaire (FABQ) and McGill Pain Questionnaire were applied before the treatment sessions~     started, after the treatment sessions ended and three months after the study. Gradient of~     disc height and thickness of the herniation were assessed segmentally with magnetic resonance~     imagination (MRI) before the study and three months after the study.~   "
75969|NCT02572583|"~     This prospective randomized controlled trial studies the efficacy and safety of treating~     influenza with the reconciling exterior and interior therapy. A total of 300 cases of~     seasonal flu in Beijing is to be collected, and divided into one treatment group and two~     control groups. Patients in the treatment group will receive Liugan Shuangjie Heji, while~     patients in control groups will receive Shufeng Jiedu Capsule and Oseltamivir Phosphate~     Capsule respectively, for a course of 5 days. The study assesses the efficacy and safety of~     treating influenza with the reconciling therapy based on the following outcome measures: the~     time it takes from the medicine intake to 0.5℃ drop of body temperature, and the time it~     takes for the body temperature to return to normal.~   "
75970|NCT02572570|"~     Polymerization shrinkage remains one of the primary disadvantages of composite resin~     restorative materials (tooth-colored fillings). To minimize the effects of polymerization~     shrinkage in the restorative treatment, the 3M ESPE company has developed a composite resin~     called Filtek Bulk Fill Posterior Restorative. Its decreased polymerization shrinkage and~     properties allow the material to be inserted in one single increment, expediting treatment.~     This clinical trial is designed to evaluate the performance of the new bulk fill composite~     resin in Class II (two-surface posterior) fillings.~   "
75971|NCT02572557|"~     Rationale: Spray cryotherapy (SCT) using liquid nitrogen has been safely and effectively used~     in the esophagus, airways and pleura. Treatment with SCT for central airway stenosis may~     provide an effective, and more durable and perhaps safer alternative to the current~     therapeutic modalities.~      Objectives:~        1. To investigate the feasibility of using Spray cryotherapy (SCT) for the treatment of~          malignant and benign central airway disease.~        2. To investigate the safety of using Spray cryotherapy (SCT) for the treatment of~          malignant and benign central airway disease.~        3. To investigate the efficacy of using Spray cryotherapy (SCT) for the treatment of~          malignant and benign central airway disease.~      Study design: This study will be a prospective, single arm, open label intervention study~     performed at the University Medical Center Groningen, The Netherlands Study population: The~     study population exists of 25 patients with malignant or benign central airway disease.~     Patients in which current treatment options are regarded to be suboptimal can be included in~     the study.~      Intervention: TruFreeze Spray CryoTherapy~      Main study parameter:~      Feasibility is defined as being able to apply the SCT as planned in one, or more~     bronchoscopies according to the instructions for use (IFU).~      Secondary study parameters:~      Safety will be assessed by capturing all adverse events (AEs) that occur 1) during the SCT~     procedure, and 2) all AEs that occur until hospital discharge.~      Efficacy will be measured using 1) patient reported outcomes (questionnaires), 2) percentage~     improvement in airway stenosis, 3) durability of treatment effect, 4) need to re-intervene~     with other therapies because of treatment failure.~      Nature and extent of the burden, risks and benefit associated with participation.~      Patients that will be recruited and participate in this prospective clinical trial have a~     severe central airway disease which is highly symptomatic for which current available~     therapies are either very difficult to perform, are hazardous, have no real benefit, or just~     simply not available yet. The current treatment risks of this patient group are high,~     especially in the patients where the airway patency is at risk. The main additional risk~     associated with the use of SCT is the occurrence of a pneumothorax. Patients participating~     will adhere to their current medical care, with the one addition of a voluntary follow-up~     bronchoscopy after SCT.~   "
75972|NCT02572544|"~     Purpose of this study is to compare the ocular functional changes including pupil size,~     visual acuity, depth of focus, accommodative amplitude, visual field, contrast sensitivity,~     and stereopsis induced by multiple and single pinhole glasses, in addition, to check reading~     speed and survey for ocular discomfort after using both pinhole glasses.~   "
75973|NCT02572531|"~     The aim of this research is to study the effect of probiotic supplements (Lactobacillus~     reuteri) on post-surgical complications and oral wound healing after extraction of impacted~     third molars.~   "
75974|NCT02572518|"~     To evaluate the immune status of yellow fever in adults with a history of two or more doses~     of vaccine, having received the second dose for at least 1 year, compared to re-vaccinated~     individuals (second dose) after 30 days.~   "
75975|NCT02572505|"~     Human immunodeficiency virus (HIV) infection has now become a treatable disease and many~     infected individuals are interested in having a family. Couples in which the man is infected~     but the woman is HIV-negative (hereafter referred to as HIV-discordant) require medical~     intervention during procreation to prevent HIV transmission to the female and her child. The~     current view is that reducing the number of infections involving unprotected intercourse in~     HIV-discordant couples is a public health issue in the U.S. The safest methods for~     HIV-discordant couples are insemination using a sperm donor, adoption and remaining~     childless. However, some couples strongly desire a biologically related child. Fertility~     clinics in the United States have been resistant to treating HIV-discordant couples, offering~     only expensive, invasive techniques. This reduces access to care, leading to couples choosing~     unprotected intercourse to conceive a child. Pre-exposure prophylaxis (PrEP) is a treatment~     taken by the woman before having unprotected intercourse with an infected man. Truvada has~     been approved by the Food and Drug Administration (FDA) to reduce the risk of HIV-discordant~     couples and the Centers for Disease Control and prevention (CDC) has recommended that~     serodiscordant patients who wish to have a child be counseled on the availability of PrEP.~     When risks of transmission are minimized, including undetectable HIV in blood and use of~     PrEP, unprotected intercourse during the fertile period is likely to be a safe option for~     conceiving a child. The investigators propose to enroll HIV-discordant couples who have been~     counseled on the safer alternatives of donor insemination, adoption and remaining childless;~     have been offered referral to a clinic offering sperm washing with insemination or in vitro~     fertilization (IVF); have been apprised of the risks of using PrEP and one timed intercourse~     per cycle; and decide to proceed with this method. Couples will be from the population of~     HIV-discordant patients with a minimal risk of disease transmission as described above. After~     evaluation for normal fertility and low potential for disease transmission, the couple will~     receive instruction on timing of the most fertile day of the cycle, and the woman will be~     given a prescription for the PrEP medication. The woman and any offspring will be followed~     for 6 months using blood tests to check for evidence of HIV infection.~   "
75976|NCT02572492|"~     This study evaluates induction therapy with carfilzomib-cyclophosphamide-dexamethasone before~     salvage high-dose melphalan with autologous stem cell support (HDT) in multiple myeloma~     patients with relapse after HDT done at diagnosis. In addition, the study evaluates the~     effect of maintenance therapy after salvage HDT in multiple myeloma. After salvage HDT half~     of the patients receive maintenance therapy with carfilzomib/dexamethasone while the other~     half are observed without maintenance therapy.~   "
75977|NCT02572479|"~     The proposed observational trial will collect substantial data concerning dietary intake~     documented by ALS patients complemented by the analysis of fatty acid distribution in~     erythrocyte lipids. Both data sets are related to disease status and progress.~   "
75978|NCT02572466|"~     This study objective is to compare the high sensitive troponin-I level in end-stage renal~     disease patients received hemodialysis without acute cardiovascular event with healthy~     population. The investigators also determine the effect of hemodialysis on troponin I level~     as the secondary objective.~   "
75979|NCT02572453|"~     This phase II trial studies how well onalespib works in treating patients with anaplastic~     large cell lymphoma, mantle cell lymphoma, or diffuse large B-cell lymphoma that has not~     responded to previous treatment or that has returned after a period of improvement. Onalespib~     may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~   "
76058|NCT02571426|"~     It is known that volatile anesthesia, such as sevoflurane, retain water and that this appears~     more pronounced in children. However, the mechanisms for this effect is unknown and it is not~     clear if the commonly used anesthetic propofol does the same. In this study the investigators~     want to compare the fluid and electrolyte conserving effects of sevoflurane and propofol in a~     pediatric setting and also investigate humoral changes induced by these anesthetics.~   "
75980|NCT02572440|"~     Perioperative blood loss continues to be a serious problem in complex aortic arch surgery~     using deep hypothermic circulatory arrest (DHCA). Major blood loss causes increased morbidity~     and mortality [1]. These patients often require transfusion of allogeneic blood products. It~     has been estimated shortages of blood supply in China will worsen [2]. Clinicians have made~     significant progress to decrease the quality of allogenic blood transfusion.~      Increasing postoperative hemorrhage risk of aortic arch patients undergoing DHCA may be~     related to CPB induced hemostatic defect, the use of the CPB is likely to contribute to~     coagulation factor lost and platelet dysfunction [3, 4]. We are aware of the potential~     benefit of aPRP, withdrawal of aPRP immediately before initiating CPB appears to be a~     promising approach because it avoids CPB-related platelet damage and limits post-CPB blood~     loss. So we adopted and used aPRP as a blood conservation technique to reduce blood~     transfusion in aortic arch surgery with DHCA. Autologous red blood cells were infused to~     maintain a HGB level above 100 g/L after heparin neutralizing activity. And aPRPs were~     transfused after heparin neutralizing activity as no active bleeding was observed. Our goal~     was to determine the effect between aPRP and homologous transfusion on perioperative bleeding~     during complex aortic arch surgery using DHCA.~   "
75981|NCT02572427|"~     The overall goal of this study was to create a simulation environment with repeated practice~     for residents and intense, immediate feedback. Repeated simulations for neonatal~     resuscitation when coupled with clinical experience have been shown to improve resident~     confidence.The investigators sought to determine if resident exposure to individual training~     and video laryngoscopy using the C-MAC video laryngoscope would improve cognitive skills and~     decrease intubation times in a neonatal manikin. The primary outcome was time to intubation~     after one year. The secondary outcome was the ability to retain cognitive instruction related~     to intubation~   "
75982|NCT02572414|"~     African American men infected with HIV are living longer and are acquiring the same chronic~     non-communicable diseases affecting the general population of African American men age 40~     years and older. African American men have disproportionately high rates of cardiovascular~     disease, hypertension, diabetes, kidney disease, and cancer, particularly prostate and colon~     cancer, but HIV is associated with an increased risk for co-morbidity from these conditions,~     a risk heightened by not only HIV infection itself, but also its treatment with~     antiretroviral therapy (ART). The risk for many of these chronic diseases is tied to~     behavior: risk is increased by physical inactivity and unhealthful diet. Although the high~     risk for behavior-linked chronic diseases among HIV-positive individuals has been recognized,~     there is a lack of evidence-based interventions specifically tailored to their needs.~      Hence, the broad objective of this research is to identify strategies to empower HIV positive~     African American men to engage in behaviors that reduce their risk of chronic diseases. This~     research will test the efficacy of a theory-based, contextually appropriate health promotion~     intervention in inducing positive changes in behaviors linked to risk of chronic diseases~     among HIV positive African American men age 40 years or older and will identify the~     theoretical variables that mediate its efficacy.~      In a randomized controlled trial, African American HIV positive men age 40 or older who are~     receiving ART for HIV will be randomized to the Men Together Making a Difference Health~     Promotion Intervention, which consists of three, 3-hour weekly intervention sessions, or the~     1 session Health Awareness Control Group. The Men Together Making a Difference Health~     Promotion Intervention is based on social cognitive theory and the reasoned action approach~     integrated with formative research. Data will be collected at baseline, immediately post, and~     3, 6 and 12 months post intervention. The trial will test whether the Men Making a Difference~     Health Promotion Intervention increases self-reported physical activity compared with the~     Health Awareness Control Group.~   "
75983|NCT02572401|"~     African American men have by far the highest rates of HIV in the US, but there are few~     randomized controlled trials (RCTs) of interventions to dissuade heterosexually active~     African American men from engaging sexual risk behavior. This research seeks to address this~     gap in the behavioral intervention literature. That self-initiated behavior change, as well~     as intervention-induced behavior change, is often short-lived, eroding over time, is widely~     known; accordingly, this research also seeks to test a strategy to sustain intervention~     efficacy. In a RCT, African American men 18 to 45 years reporting recent unprotected~     intercourse with a woman will be randomized to the Steering Together in a New Direction~     (STAND) HIV Risk Reduction Intervention or a No-Intervention Control Condition. To test a~     strategy to sustain intervention effects, the men also will be randomized to receive or not~     receive individually tailored text messages. The theoretical basis of the interventions is~     social cognitive theory and the reasoned action approach, which is an extension of the theory~     of planned behavior and the theory of reasoned action. Men will complete self-report measures~     via audio computer-assisted self-interviewing at baseline and immediately post and 6 and 12~     months post-intervention. The trial will test whether the STAND HIV Risk Reduction~     Intervention as compared with the No-Intervention Control Condition, increases consistent~     condom use, the primary outcome. Secondary outcomes include unprotected intercourse, multiple~     sexual partners, insertive anal intercourse, and proportion condom-protected intercourse. The~     trial will also test whether STAND's efficacy is greater among men in the Text Messaging~     Intervention compared with men not receiving text messages. This will provide information on~     the utility of a low-cost strategy to extend an intervention's efficacy. Finally, the study~     will test for mediation of intervention effects: the hypothesis that STAND affects outcome~     expectancies and self-efficacy, which, in turn, affect consistent condom use.~   "
75984|NCT02572388|"~     This is a clinical trial in which healthy volunteers will be administered one or two~     experimental malaria vaccines. The vaccine R21 will either be administered alone or in~     combination with the adjuvant vaccine Matrix-M1.~      All vaccinations will be administered intramuscularly. Each volunteer will receive three~     vaccinations in total.~      There are three different vaccine schedules:~      Group 1 will receive 10µg of R21 mixed with 50µg of Matrix-M1 on days 0, 28, and 56.~      Group 2 will receive 50µg of R21 on days 0, 28, and 56. .~      Group 3 will receive 50µg of R21 mixed with 50µg of Matrix-M1 on days 0, 28, and 56.~      The study will assess the safety of the vaccines, and the immune responses to the~     vaccinations. Immune responses are measured by tests on blood samples.~      Healthy adult volunteers will be recruited in Oxford and London, England.~   "
75985|NCT02572375|"~     The objectives of this pivotal study are:~        1. to evaluate bioavailability of an extended-release and immediate release Codeine~          Phosphate/Guaifenesin tablet at steady state following multiple oral administration~        2. to assess the safety and tolerability of this Codeine Phosphate/Guaifenesin extended~          release formulation.~   "
75986|NCT02572362|"~     Retrospective study comparing dose distribution of 3D conformal radiotherapy (3DCRT) and~     volumetric-modulated arc therapy (VMAT) to estimate secondary cancer risk for patients having~     had radiation therapy for rectal cancer. Twenty-five patients are included in this study.~     Planning CT scans are used for comparison of dose distribution and calculation of second~     cancer risk.~   "
75987|NCT02572349|"~     The objectives of the study are to assess the safety and tolerability of a range of single~     doses of IW-1701 when administered as oral capsules to healthy subjects, to determine the~     pharmacokinetic profile and pharmacodynamics effects of a range of single doses of IW-1701~     when administered as oral capsules to healthy subjects.~   "
76022|NCT02571894|"~     The main objective of this randomized controlled trial is to test the association between~     standard cardiac risk factors, biomarkers and parameters of echocardiography,~     electrocardiography, and cardiac magnetic resonance imaging, (predictors) and subsequent~     occurrence, frequency and severity of clinical or subclinical cardiotoxicity (outcome) within~     and between-groups, before start of chemotherapy, during treatment and at 1, 5, and 10 years~     after the completion of the chemotherapy among women with early breast cancer.~   "
75988|NCT02572336|"~     This study will test the experimental drug THR-18 given together with the drug tissue~     plasminogen activator for the treatment of stroke. Tissue plasminogen activator is also~     called tPA.~      Strokes often result from blockade of blood supply caused by blood clots forming within the~     blood vessel feeding the brain. Such strokes are called Ischemic strokes. Treatment of~     these strokes is aimed at breaking up the blood clot(s) and renewing the blood flow before~     further parts of the brain die. Breaking up the blood clot is possible with the drug tPA when~     it is injected into a vein shortly after the stroke starts. However, along with breaking up~     the blood clot, tPA sometimes causes adverse effects, for example, it may cause bleeding.~     THR-18, the drug tested in this study, is meant to reduce tPA's adverse effects without~     stopping tPA's breaking up of the blocking blood clot.~      The aims of this study are to evaluate the safety of THR-18 in acute ischemic stroke patients~     who are treated in parallel with tPA, to measure tPA's effect on blood clot dissolution when~     this drug is given with and without THR-18, and to study the effects THR-18 may have on~     signals of brain damage as seen on brain computerized tomography (a type of brain x-ray)~     after treatment with tPA with and without THR-18. Patients will also be evaluated for their~     ability to perform daily activities after the stroke following tPA treatment with and without~     THR-18.~      The evaluation of THR-18 in this study will be done in comparison to placebo. Placebo is a~     drug that looks exactly like THR-18 but has no activity. One dose of THR-18 will be tested,~     in 20 patients. In parallel, 20 other patients will receive placebo. In total, 40 patients~     are planned to participate in this study. The decision whether a patient will receive THR-18~     or placebo will be based on chance (this procedure is called randomization). This clinical~     study will be conducted only at one hospital, in the Republic of Moldova. The patients will~     be in the hospital for at least 3 days after receiving the study treatment. Then, about 1~     month later, they will be invited for a last follow-up visit.~   "
75989|NCT02572323|"~     The aim of this study is to test whether tesamorelin, in combination with a text-messaging~     application to help with motivation and adherence, will significantly improve memory and~     thinking in HIV.~   "
75990|NCT02572310|"~     In this study the investigators propose to monitor subjects who have received Triathlon total~     knee components inserted with HV cement. The primary outcome will be fixation of the tibial~     implant component as assessed with RSA and to determine the functionality of patients after~     surgery using self-reported questionnaires. This is a historical control study, comparing the~     study cohort to a previous group with Triathlon implants and the long-standing Simplex T~     cement. The secondary outcomes are inducible displacements of the implants as well as a~     qualitative evaluation of the cement handling characteristics performed by the operating room~     staff.~   "
75991|NCT02572297|"~     Sudden unexpected death in epilepsy (SUDEP) is the main concern of professionals and patient~     associations involved in epilepsy. These represent a priority for the Ligue Française Contre~     l'Epilepsie (LFCE). The SUDEP affect primarily young adults, between 18 and 40 years,~     suffering from epilepsy uncontrolled by medication. In this population of close to 100,000~     people in France, the incidence of SUDEP is estimated at 0.5%, or nearly 500 deaths per year.~     It is clear that the majority of these deaths occur in the immediate consequences of a~     crisis..~      Investigators suppose that a causal link exists between the occurrence of a SUDEP and a per /~     post-critic decline of SpO2 below 80 % (75 % of cases, 20 % of controls).The constitution of~     a cohort of 1500 patients clinically well described and a national database will allow other~     ambitious projects in a speciality where French centres benefit from a unique knowledge,~     recognized by their foreign colleagues, but underexploited to date. The LFCE (Ligue Française~     Contre l'Epilepsie) is developing structuring actions to facilitate such exploratory studies~     for the next two years.~      The high death rate which characterizes the drug-resistant partial epilepsies and, in~     particular, Sudden Unexpected Deaths in Epilepsy (SUDEP) represents the main axis of research~     for the Ligue Française Contre l'Epilepsie (LFCE) as well as for associations of epileptic~     patients and the European representatives of the international league against epilepsy (~     ILAE). Today, SUDEP occurrences cannot be anticipated. Patients can't be warned against~     SUDEP.~      Although the SUDEP physiopathology remains uncertain, many elements plead for the essential~     role of a per-and post-critic apnea (central or obstructive). Investigators observe that~     about 20 % of the patients admitted in a EEG-video monitoring - EEG unit for recording their~     crisis are going to present experience an per / post-critic severe apnea, severe per /~     post-critic enough to have induce a SpO2 < 80 % decrease.~      However, today, no study has estimated the link relation between the arisen occurrence of~     such apneas and the later risk of SUDEP.~   "
75992|NCT02572284|"~     The purpose of this study is to compare the effects, good and/or bad, of different doses of~     SBRT given before prostatectomy. Depending when participants enter the study, they will be~     treated with either 5 or 6 gray (Gy) per day of radiation. A Gy is a measure of radiation~     dose. The standard dose is 10Gy per day when SBRT is the only treatment to the prostate and~     no surgery is planned. The researchers want to see which dose of radiation will work best~     with the least amount of side effects. About 4-6 weeks after SBRT, participants will have a~     prostatectomy.~   "
75993|NCT02572271|"~     The purpose of this study is to compare two different techniques of mastopexy with autologous~     augmentation, the Lower Pole Subglandular Advancement Mastoplasty (LOPOSAM) and Rubins~     Mastopexy with autologous augmentation, in massive weight loss patients to see if one~     technique is superior to the other.~   "
75994|NCT02572258|"~     The study will evaluate the impact of a supplementary food (cookies) in preventing the risk~     of developing moderate acute malnutrition (MAM) in preschool mildly malnourished children.~      Children will be divided in two groups; one will received the cookie plus 12 educative~     sessions and the other just the educative program. The study will last 12 months~   "
75995|NCT02572245|"~     This is a study comparing adalimumab Pfizer (PF-06410293) administered as a subcutaneous(SC)~     injection using a pre-filled syringe (PFS) or pre-filled pen in healthy adult subjects~   "
75996|NCT02572232|"~     The purpose of the study is to compare three supraglottic airway devices (Combitube,~     Easytube, laryngeal mask airway) to endotracheal intubation in a simulated difficult airway~     scenario in a pediatric manikin.~   "
75997|NCT02572219|"~     Aim of this randomized, double-blind clinical study is to evaluate the efficacy of a~     nutraceutical preparation on early markers of cognitive impairment, in patients affected by~     arterial hypertension.~   "
75998|NCT02572206|"~     The primary goal of the present study is to evaluate the utility of mGluR5 binding as~     measured by PET as a biomarker of the CNTNAP2 mutation and related /mTOR kinase pathway~     dysregulation.~   "
75999|NCT02572193|"~     This is a study of an investigational surgical procedure for the treatment of achalasia the~     inability of smooth muscle to move food down the esophagus. A new procedure, called the POEM~     procedure (per oral endoscopic myotomy) has been developed for achalasia. This study is being~     performed to determine if patients can go home on the same day as their procedure.~   "
76023|NCT02571881|"~     Constipation is common in pregnant women. Surgery, anaesthesia and opioid analgesics may~     further impair bowel function. The aim of the present study was to evaluate if~     oxycodone-naloxone combination compared to oxycodone reduced bowel dysfunction in patients~     undergoing caesarean section.~   "
76024|NCT02571868|"~     AtrioVentricular (AV) and InterVentricular (VV) delay optimization can improve ventricular~     function in Cardiac Resynchronization Therapy (CRT) and is usually performed by means of~     echocardiography. St Jude Medical has developed an automated algorhythm which calculates the~     optimal AV and VV delays (QuickOptTM) based on Intracardiac ElectroGrams, (IEGM), within 2~     minutes. So far, the efficacy of the algorhythm has been tested acutely with standard lead~     position at right ventricular (RV) apex. Aim of this project is to evaluate the algorhythm~     performance in the mid- and long-term with RV lead located in mid-septum.~   "
76000|NCT02572180|"~     This study aims towards investigating the efficacy of a near-infrared spectroscopy~     (NIRS)-based neurofeedback training in a virtual reality (VR) classroom in schoolchildren~     with attention-deficit/hyperactivity disorder (ADHD). The investigators are especially~     interested in the training's impact on academic performance, executive functioning (EF) and~     behavioral ADHD symptoms. Furthermore, the investigators aim at examining the influence of~     teachers' instructional behavior on children with ADHD's learning in a short virtual reality~     classroom scenario. Several studies provide evidence that poor academic achievement in ADHD~     is mainly due to impairments in EF and ADHD behavior (e.g., Frazier, Youngstrom, Glutting, &~     Watkins, 2007; Miller et al., 2013). Furthermore, studies show that these factors are related~     to neurophysiological characteristics found in electroencephalographic (EEG) or functional~     NIRS (fNIRS) examinations (e.g., Barry, Clarke, & Johnstone, 2003; Barry, Johnstone, &~     Clarke, 2003; Loo & Barkley, 2005; Negoro et al., 2010). Neurofeedback trainings aim at~     improving these neurophysiological as well as cognitive-behavioral deficits (Gevensleben,~     Moll, Rothenberger, & Heinrich, 2014), and are expected to improve academic performance in~     children with ADHD accordingly. Training in a VR classroom, from the investigators'~     perspective, facilitates generalization of self-regulation competences to real-life academic~     situations and at the same time increases the effort invested into the training compared to a~     training in 2D settings. Consequently, training in a VR classroom is hypothesized to lead to~     greater improvement in academic performance, EF and a greater decrease of ADHD symptoms than~     a training in a 2D setting. Moreover, the investigators hypothesize that these effects are~     more pronounced in children who receive a NIRS-based neurofeedback training compared to~     children receiving a biofeedback training based on an electromyogram (EMG).~   "
76001|NCT02572167|"~     The purpose of this study is to assess the safety profile and antitumor activity of~     brentuximab vedotin administered in combination with nivolumab in patients with relapsed or~     refractory Hodgkin lymphoma (HL)~   "
76002|NCT02572154|"~     In human, 2% of couples experimented Recurrent pregnancy loss (RPL). Currently, while~     etiological investigations were performed, 40 to 50 % of RPL were unexplained. In animals'~     studies, several studies have underlined the importance of sperm quality for a normal embryo~     development. In human, epidemiological studies have demonstrated that several male risk~     factors have effects on development (male mediated development toxicology). However, few~     studies have explored sperm DNA fragmentation on embryo development but after in vitro~     fertilization. In natural pregnancy only rare studies have been performed but with different~     populations definitions and different methods of sperm exploration. In this context sperm DNA~     fragmentation exploration appears justified. The present study purpose to conduct a case -~     control study in order to research paternal role in RPL.~   "
76003|NCT02572141|"~     BACKGROUND:~      In patients with high risk stage II and stage III colon cancer (CC), curative surgery~     followed by adjuvant chemotherapy with FOLFOX or CAPOX regimens has become a standard~     treatment. However, 20 to 30 % of these patients will develop distant metastasis, which~     ultimately result in death. Perioperative chemotherapy is a promising strategy with potential~     benefits that could be more effective at eradicating micrometastases. Moreover, shrinking~     tumor before surgery not only facilitate removal of all the tumor by the surgeon but also~     reduce tumor cell spreading during the procedure. With recent advances in radiology,~     preoperative computed tomography is a robust method for measuring the depth of tumor invasion~     and identifying the CC patients with poor prognosis, who may benefit from perioperative~     chemotherapy. The investigators conducted the present randomized study to explore whether~     perioperative chemotherapy with FOLFOX or CAPOX regimens compared with postoperative~     chemotherapy could improve disease-free survival in patients with radiologically staged,~     locally advanced, but resectable colon cancer.~      OBJECTIVE:~      The primary objective of this study is to evaluate the efficacy of perioperative chemotherapy~     with FOLFOX or CAPOX regimens compared to postoperative chemotherapy in patients with locally~     advanced colon cancer. Secondary objectives are efficacy in terms of R0 resection rate,~     overall survival (OS), relapse-free survival (RFS), down-staging of primary tumors, and~     tolerability of perioperative therapy and postoperative complications.~   "
76004|NCT02572128|"~     The investigators studies will compare iron, respectively iron and zinc bioavailability from~     fortified rice produced from different fortification techniques using stable isotopic labels.~     Study 1 aims to compare the iron bioavailability from hot and cold extruded rice, in Study 2~     the iron and zinc bioavailability from rice using one coating technique and hot extrusion~     will be compared.~   "
76005|NCT02572115|"~     The purpose of this randomized controlled trial is to test the use of an emergency button~     that allows patients to jump the telephone waiting line at the out-of-hours primary care in~     two regions in Denmark if they perceive their illness as acute and severe.~   "
76006|NCT02572102|"~     To assess the cardiac effects of an energy drink and Panax Ginseng in healthy volunteers.~   "
76007|NCT02572089|"~     To determine the pharmacokinetics of 4 intranasal doses of naloxone compared to a 0.4 mg dose~     of naloxone administrated intramuscular and to identify an appropriate intranasal dose that~     could achieve systemic exposure comparable to an approved parenteral dose. To also determine~     the pharmacokinetics of two different concentrations of intranasal naloxone and finally, to~     determine the safety of intranasal naloxone with respect to nasal irritation.~   "
76008|NCT02572076|"~     The Motus GI Colon Cleansing device is intended to facilitate intra-procedural cleaning of a~     poorly prepared colon by irrigating the colon and evacuating the irrigation fluid and feces.~   "
76009|NCT02572063|"~     The overall objective of the study is to stratify a frailty population based on nutrients~     profiling (amino acids, vitamins, minerals, fatty acids) and metabolic profiling (low~     molecular weight metabolites in urine and plasma) at baseline.~   "
76010|NCT02572050|"~     Designed as a single arm multi-center prospective phase II trial, which evaluates the number~     of dissected lymph nodes in the N2-area as a surrogate parameter for adequate D2~     lymphadenectomy in robotic distal gastrectomy (RDG) for clinical stage II or III gastric~     cancer.~   "
76011|NCT02572037|"~     An observational study on the effect of new classification for premature ejaculation.~   "
76025|NCT02571855|"~     The purpose of this study is to evaluate the tolerability, safety, pharmacokinetics (PK, or~     amount of drug over time in the body) and pharmacodynamics (PD, or effects on the body) of~     ACT-541468 following multiple ascending doses in healthy adults and following single~     ascending doses in healthy elderly subjects when administered in the morning. The safety, PK~     and PD of ACT-541468 will also be assessed after repeated evening administration of a~     selected dose in both healthy adults and elderly.~   "
76059|NCT02571413|"~     Correct methods and compliance of intranasal corticosteroid (INCS) is very important for the~     treatment of allergic rhinitis (AR). The animated cartoon-aided teaching of INCS~     administration was created to decrease workload of health care professionals. The aim of this~     study is to compare the achievement of the children with AR in using INCS between the group~     which were instructed by animated cartoon-aided teaching or oral presentation without~     demonstration.~   "
76012|NCT02572024|"~     Resistant hypertension (RH) affects some 10% to 15% of all patients with hypertension. These~     patients are at a clearly increased risk for end organ damage and mortality. Furthermore,~     arterial hypertension is a multifactorial disease including genetic, lifestyle, dietary,~     metabolic, and sympathetic factors. However, the current treatment modalities have not been~     optimal in targeting the compensatory changes in sympathetic nervous system function and new~     strategies have been warranted.~      Baroreflex activation therapy (BAT) is a special treatment option for some patients with RH~     that modulates the autonomic nervous system to restore sympathovagal balance. Notably, in BAT~     both long-term safety and efficacy in a large-scale, randomized, double blind, controlled~     trial has been shown. However, the trial design and BAT methodology resulted in that the~     first generation Rheos® system did not achieve the prespecified endpoints for short-term~     safety and efficacy.~      Notably, a second-generation minimally invasive BAT system (Barostim Neo®) has now been~     developed to address these limitations although randomized, double blind, controlled clinical~     trials are still lacking. Noteworthy, in the recent European Society of Hypertension/European~     Society of Cardiology (ESH/ESC) Guidelines for the management of arterial hypertension,~     carotid baroreceptor stimulation is mentioned as one of the options to treat resistant~     hypertension.~      Based on these data the aim of this randomized, double-blind, parallel-design clinical trial~     is to examine the effect of BAT compared to continuous pharmacotherapy on blood pressure, as~     well as arterial and cardiac function and structure using non-invasive high technology~     methodology, in a Nordic multicentre study.~      This study will include 100 patients with RH (20 from Helsinki). Eligible patients are~     between 18 and 70 years and have a daytime systolic ambulatory blood pressure 145 mmHg or~     more, and/or a daytime diastolic ambulatory blood pressure of 95 mmHg or more, after~     witnessed intake of antihypertensive treatment (including at least 3 antihypertensive drugs~     preferably including a diuretic), with no changes in medication for a minimum of 4 weeks~     prior to enrolment. Patients with severe renal insufficiency, type 1 diabetes, psychiatric~     illness, severe cardiovascular disease, or any complication that is a risk to the planned~     surgery are exclusion criteria.~      The primary end point is to test whether BAT reduces 24-hour systolic ambulatory blood~     pressure at 8 months of follow-up compared to continuous pharmacotherapy. Secondary end~     points are to test whether BAT reduces home blood pressure during follow-up compared to~     continuous pharmacotherapy, whether BAT reduces office blood pressure during follow-up~     compared to continuous pharmacotherapy, and the effect of BAT on autonomic function measured~     as eg. baroreflex sensitivity and heart rate variability.~   "
76013|NCT02572011|"~     Lower limb amputees have reduced joint mobility and strength which negatively influence an~     individual's ability to maintain balance. Individuals with lower limb amputation also have an~     increased fear of falling and reduced social participation because of this fear. Improving~     balance ability, reducing falls and fear of falling through effective balance training~     interventions would have a number of socio-economic benefits. The aim of the current study is~     to investigate whether taking part in a games console based-balance intervention, improves~     balance ability in individuals with lower limb amputation.~   "
76014|NCT02571998|"~     The primary objective of this study is to evaluate the safety and efficacy of Omiganan~     (CLS001) topical gel compared to vehicle topical gel applied once daily for 12 weeks in~     female subjects with moderate to severe inflammatory acne vulgaris.~   "
76015|NCT02571985|"~     The PRESERVE-Zenith® Iliac Branch System Clinical Study is a clinical trial to collect~     confirmatory safety and effectiveness data on the Zenith® Branch Endovascular Graft-Iliac~     Bifurcation System. This system is made up of two devices: the Zenith® Branch Endovascular~     Graft-Iliac Bifurcation and the ConnectSX™ covered stent in the treatment of aorto-iliac and~     iliac aneurysms~   "
76016|NCT02571972|"~     This study seeks to evaluate the effect of topical aqueous suppression on the anatomic and~     functional response to intravitreal anti-vascular endothelial growth factor (VEGF) injections~     in non-responders with wet age-related macular degeneration.~   "
76017|NCT02571959|"~     Description of the pharmacokinetic parameters of the amoxicillin / clavulanic acid to healthy~     voluntary obese after oral and intra venous administration Determination of the~     pharmacokinetic parameters of amoxicillin / clavulanic acid obtained from plasmatic~     concentrations of intravenous injection (IV) and oral administrations. The criterion of~     evaluation allowing to answer our main objective corresponds to the parameters estimated by~     the pharmacokinetic model of the concentrations obtained from the data IV and by the~     pharmacokinetic model of the concentrations obtained from the oral data. The following~     pharmacokinetic parameters will be considered at every obese volunteer's for both molecules~     (amoxicillin and clavulanic acid) from the concentrations by pharmacokinetic analysis of~     population.~      The main evaluation criteria are PK parameters of amoxicillin / clavulanic:~        -  Cl, systematic plasmatic clearance~        -  Vd, volume of distribution~        -  ASC 0-oo, area under the curve time - concentration~        -  T1/2, half-life time~        -  F, bioavailability after oral administration~        -  Ka, constant of speed of absorption~   "
76018|NCT02571946|"~     The standard treatment of advanced hepatocellular carcinoma (HCC) is sorafenib. Though the~     agent showed clear survival benefit in two randomized phase III trials, the benefit was~     modest and response rate was just a few percent. Therefore, other loco-regional modalities,~     like trans-arterial chemo-embolization (TACE), hepatic arterial infusion chemotherapy (HAIC),~     and radiotherapy (RT) were continuously tried, especially in locally advanced HCC including~     portal vein tumor thrombosis (PVTT).~      With the advancement of conformal RT techniques, RT was actively applied in HCC, especially~     in PVTT combined HCC. Many researchers reported that there is a relationship between RT dose~     and tumor response rate. RT dose, however, is frequently limited because the complications~     (like radiation induced liver disease (RILD), radiation induced gastro-duodenal toxicity,~     etc.) are also closely related with higher exposed RT dose.~      Proton beam has characteristic depth-dose distribution contrast to photon, the Bragg peak.~     The advantage of this dose distribution could be more highlighted in HCC management, because~     of the weakness and maintenance importance of liver function itself in HCC patients. In fact,~     the superior results of proton beam therapy in HCC were constantly reported in several groups~     as prospectively as well as retrospectively.~      In those background, the investigators planned the present study to evaluate the efficacy and~     safety of proton beam therapy in HCC patients combined with PVTT.~   "
76019|NCT02571933|"~     This study evaluates the face validity and cultural acceptability of the Faces Pain Scale -~     Revised in pediatric patients treated at Mbingo Baptist Hospital, Northwest Province,~     Cameroon. Participants from the four major language/cultural groups evaluated at the hospital~     with a complaint of pain will trial the Faces Pain Scale - Revised and then undergo cognitive~     interviewing to assess comprehension and clinical accuracy.~   "
76020|NCT02571920|"~     Describe the proportion of patients who underwent cardiac surgery in France and benefiting~     from a monitoring cardiac output, describe the use of positive inotropic and vasoactive~     agents for cardiac surgery patients operated (type of catecholamines, their duration),~     describe the fluid replacement and transfusions of first 24 hours, describe the incidence of~     postoperative complications in patients undergoing cardiac surgery.~   "
76021|NCT02571907|"~     The purpose of this extended study is to evaluate the safety and effectiveness of the Zenith®~     Branch Endovascular Graft-Iliac Bifurcation in combination with the commercially available~     Atrium iCAST™ covered stent in patients in a treatment of aortoiliac and iliac aneurysms.~   "
76026|NCT02571842|"~     Currently, the treatment options of recurrent IgA nephropathy (IgAN) are conflicting and~     largely based on expert opinions. Consequently, the recent KDIGO clinical practice guideline~     for the care of kidney transplant recipients has concluded that there are no definite~     strategies for prevention and treatment. However, recurrent IgAN in the transplanted kidney~     is common and may contribute to graft loss, in particular, if cresentic formation, extra- or~     endocapillary proliferation were presented in kidney pathology. Herein, the investigators~     assume that rituximab, anti-CD20 Ab agent, can reduce circulating IgA with subsequently~     decrease rate of polymeric forms of IgA deposition in glomerular capillaries. Therefore, the~     investigators speculate that rituximab may have potential effect to reduce circulating~     polymeric forms of IgA and slow progression of recurrent IgAN.~   "
76027|NCT02571829|"~     The purpose of this study is to determine whether ribociclib are effective and safe in the~     treatment of progressive well/dedifferentiated liposarcoma (WDL/DDL).~   "
76028|NCT02571816|"~     The purpose of this study is to compare the single-dose pharmacokinetics of ASP2215 in~     subjects with mild and moderate hepatic impairment to matched healthy subjects with normal~     hepatic function.~      This study will also assess the safety and tolerability of single-dose ASP2215 in subjects~     with mild and moderate hepatic impairment and matched control subjects.~   "
76029|NCT02571803|"~     The aim of the study is to determine, wheather strict dietary intervention with the use of~     the DASH diet atop of optimal medical treatment reduces previously diagnosed coronary~     atherosclerotic lesions assessed witch coronary computed tomography.~   "
76030|NCT02571790|"~     The purpose is threefold: Assess the anxiety reduction, the mood positive effect and the rise~     of quality of life when using methods of relaxation combined with virtual reality with~     patients suffering from generalized anxiety disorder in comparison of the effect of~     traditional relaxation therapy. Observe and evaluate the effect of perceived presence in~     synthetic environments in the virtual experience of relaxation. Evaluate the therapeutic~     efficacy of stereoscopy during exposure to relaxing virtual environments for the treatment of~     generalized anxiety disorder.~      It is a comparative, randomized, two groups study (29 in each group):~        -  Relaxation optimized virtual reality~        -  Classical relaxation (without Virtual Reality). The protocol comprised for each groups 7~          relaxing sessions (with or without virtual reality epending on the group). Each session~          lasted for approximately 30 to 35 minutes, including a 5-minute pause between immersive~          trials, in order to avoid cyber sickness in the virtual reality group.~      Expected results: a measurable therapeutic improvement produced by the combination of~     relaxation and virtual and its additional effect when compared to the traditional treatment.~      Measurements of variables and therapeutic effects will be carried out with psychometric~     measures.~      The creation process of the relaxing virtual environments has already been completed. The~     virtual environments are ready for use.~      The apparatus needed and in our possession include:~        -  A laptop for generating virtual environments~        -  A stereoscopic display~        -  Apparatus for physiological measurements~   "
76031|NCT02571777|"~     The purpose of the trial is to evaluate the efficacy and safety of two different doses of~     QVM149 (QVM149 150/50/80 μg and QVM149 150/50/160 μg via Concept1) over two respective QMF149~     doses (QMF149 150/160 μg and QMF149 150/320 μg via Concept1 in poorly controlled asthmatics~     as determined by pulmonary function testing and effects on asthma control.~   "
76032|NCT02571764|"~     Children with moderate acute malnutrition will be recruited in order to receive an~     intervention which consists in the consumption of a single serving of SF-cookies daily,~     7-days a week for 12 months and 12 educational sessions on health and nutrition.~   "
76033|NCT02571751|"~     Open-label, Multi-center, Clinical trial to Evaluate Safety and Efficacy of Cohesive~     Gel-Filled Breast Implants UNIGEL® Targeting of Women from 22 to 60 Aged with regard to~     Augmentation Mammaplasty for Purpose of Cosmetic Surgery.~   "
76034|NCT02571738|"~     A Multicenter, Randomized, Single-Blind Study with an Open-Label Extension Option to Further~     Evaluate the Safety and Efficacy of Cryopreserved Human Amniotic Membrane for the Treatment~     of Chronic Diabetic Foot Ulcers~   "
76035|NCT02571725|"~     Of the approximately 21,000 cases of ovarian cancer diagnosed annually in the U.S, ten~     percent are attributed to hereditary syndromes, most commonly the result of mutations in the~     breast cancer susceptibility genes 1 or 2 (BRCA1 or BRCA2). Mutation in these genes results~     in the inability to repair double-stranded breaks in DNA. Treating these tumors with~     poly(adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitors results in the specific~     killing of BRCA negative cells by blocking a second DNA-repair mechanism. Treatment of~     ovarian cancer patients with PARP inhibitors has resulted in improved progression free~     survival (PFS), but not overall survival (OS). It's not completely understood why this is the~     case, but some preclinical studies using ovarian cancer models in mice have suggested that~     combining PARP inhibitors with immune system modulators like T cell checkpoint inhibitors~     improves long-term survival.~      Therefore, the purpose of this study is to evaluate the safety and efficacy of a combination~     of a PARP inhibitor (Olaparib) with a T cell checkpoint inhibitor (the anti-CTLA-4 antibody~     Tremelimumab) in women with recurrent BRCA mutation-associated ovarian cancer.~   "
76036|NCT02571712|"~     A study to evaluate the long-term safety of GANFORT® (bimatoprost 0.03% plus timolol 0.5%) in~     Chinese patients with open-angle glaucoma or ocular hypertension who are insufficiently~     responsive to topical beta-blocker or prostaglandin analogues.~   "
76037|NCT02571699|"~     The aim of this study is to determine the minimum effective volume of LA in 90 % of patients~     (MEV90) required for US-guided subgluteal sciatic nerve block.~   "
76038|NCT02571686|"~     The aim of this project is to test the accuracy of pulse oximeters during mild, moderate and~     severe hypoxia. This is done by comparing the reading of the pulse oximeter during brief,~     steady state hypoxia with a gold-standard measurement of blood oxyhemoglobin saturation~     (arterial blood sample processed in a laboratory hemoximeter). The data obtained is submitted~     by pulse oximeter manufacturers to the FDA for device approval.~   "
76039|NCT02571673|"~     This study is being done to understand how survivors of head and neck cancer think they can~     make HN-STAR (the Survivor Self-Assessment, the survivorship clinic experience, and the~     Survivorship Care Plan the best it can be. Once the investigators have your input and input~     from other survivors, they can make changes to HN-STAR, so that they can test this tool in a~     larger study. The larger study will tell them whether using HN-STAR improves the care of head~     and neck cancer survivors.~   "
76040|NCT02571660|"~     Asthma is a disease that represents a public health problem worldwide, there are several~     barriers, especially in pediatric patients with this disease, them, prevent the adequate~     control of their condition, in addition every day there are new processing aids for this~     entity; within these novel research we founded the relationship between decreased vitamin D~     serum levels and his role in the regulating of the immune response, also this relationship in~     the pathophysiology of this disease and responses in the event of infectious diseases of the~     respiratory tract which can exacerbate symptoms in pediatric patients. We have been some of~     clinical trials with the aim of improving serum levels of vitamin D in asthmatic patients,~     however, these studies have different sources of bias and thus far there is no solid evidence~     that favors or denies the relationship between asthma and vitamin D, this paper aims to help~     generate this evidence to improve clinical management of these patients and their lung~     function and increase the free time crisis.~      In this trial two study groups which are divided for each of the interventions described~     below:~      Group low supplementation dose: 1 tablet of 400 IU was administered every 24 hours via oral,~     regardless of time or if it is before or after food, preferably in the morning to improve~     adherence to treatment, will be completed one year of treatment without suspension.~      Group high supplementation dose: 1 tablet of 1600 IU should be administered every 24 hours~     via oral, regardless of time or if it is before or after food, preferably in the morning to~     improve adherence to treatment, will be completed one year of treatment without suspension~     thereof.~   "
76041|NCT02571647|"~     Visual disorders are often overlooked in the treatment of cognitive disorders of the elderly.~     Yet the visual deficit impacts the quality of life, the evolution of the autonomy and~     psycho-behavioral disorders in cognitive diseases. The main objective of the study is to~     evaluate the prevalence of visual disorders among elderly patients at consultant outpatient~     center of Nantes clinical gerontology as part of the consultation geriatric memory. Secondary~     objectives are to describe ophthalmological diseases detected and taken into the proposed~     ophthalmic load, to determine if there are associations between eye diseases and cognitive~     disorders, to estimate the proportion of patients who may have an ophthalmologic evaluation~     to determine the cognitive profiles and geriatric evaluation and ocular pathological,~     depending on the assessment of arterial stiffness. The results of this study will build a~     testing strategy to promote access of older patients with cognitive impairment to vision~     care.~   "
76042|NCT02571634|"~     The purpose of this study is to evaluate the effectiveness, feasibility and safety of~     intranasal fentanyl (Lazanda) as an alternative to the current gold standard (diazepam) to~     produce anxiolysis and improve patient comfort during and after radiofrequency ablations of~     the lumbar facet joints. If this pilot study shows a positive effect and Lazanda is found to~     be feasible and safe for use during procedures, future larger scale studies can be done.~   "
76043|NCT02571621|"~     Retrospective evaluation of a database of ETC routine uses during general anaesthesia.~   "
76044|NCT02571608|"~     Type II Diabetes Mellitus patients having surgery who adhere to their regular scheduled~     metformin dosing and take this medication on the morning of surgery will have better glycemic~     control peri-operatively and potentially suffer less morbidity compared to individuals taking~     a placebo.~   "
76045|NCT02571595|"~     Sleep problems, such as insomnia, are more frequent and intense in individuals living with~     HIV. These sleep difficulties can increase the difficulties in thinking and concentrating.~     Digital cognitive behavioral therapy for insomnia (dCBT-I) is a computer-based treatment~     intervention that provides strategies to improve sleep. This intervention has been shown to~     improve sleep and daytime function (concentration, productivity) in people with insomnia.~     However, the effects of this intervention in people living with HIV are unknown.~   "
76046|NCT02571582|"~     Advanced Pulmonary Disease (PAD) is a condition that affects countless individuals around the~     world. Patients are often functionally very limited, with premature death, which is due to~     the disease itself or its complications. Currently, there are numerous monitoring centers of~     these patients to increase survival, reduce costs and humanize care in these patients.~   "
76047|NCT02571569|"~     Investigate the safety, tolerability and pharmacokinetics of BAY1093884 after Intravenous~     (IV) and subcutaneous (SC) administration of increasing single doses and SC administration of~     multiple doses.~   "
76048|NCT02571556|"~     To evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate~     ophthalmic solution, EGP-437®, using the EyeGate® II Drug Delivery System (EGDS) in patients~     having undergone cataract surgery with implantation of a posterior chamber intraocular lens~     (IOL)~   "
76049|NCT02571543|"~     During natural cycle in vitro fertilisation, no gonadotropin stimulation is used to stimulate~     oocyte production. Ovulation is induced with HCG (human chorionic gonadotropin) and the~     follicle is retrieved 36 hours later.~      In this study the patient in the intervention group will receive Ibuprofen as a study~     intervention beginning at the same time as the HCG injection. The treatment dose will either~     be 400mg every 8 to 12 hours or 800mg every 8 to 12 hours until the follicle retrieval,~     totalling 5 tablets. Instead of the usual time period of 36 hours, the follicular punction~     will occur after 42 hours. Should the oocyte still be accessible after this time period, then~     it is proven that Ibuprofen delays ovulation. In this case the patient will continue the~     regular NC-IVF treatment cycle.~      The study design is a admissible two-stage design. During stage 1, 8 cycles in 8 patients~     will be examined. Should it be the case that after these 8 patients have completed a cycle, 4~     or more show a positive treatment effect from the Ibuprofen intake, then the study will~     continue to stage 2 with 17 more more patients, totalling 25.~      Should it be the case however, that after 8 patients, 3 or less show an effect of the~     Ibuprofen intake, then the study will be stopped prematurely for futility. The study~     intervention will be increased to 800mg of Ibuprofen and the study will recommence with 8~     more patients.~      A control group will consist of women undergoing intrauterine insemination (IUI) or timed~     sexual intercourse (TSI). 42 hours after Beta-HCG injection, an ultrasound examination will~     be performed in order to determine the number of remaining follicles in the ovary. This~     examination is to verify and control the proposed time limit of 42 hours.~   "
76060|NCT02571400|"~     Post-surgical opioid prescribing intended for the short-term management of acute pain may~     lead to long-term opioid use, and its associated harms. This study was undertaken to~     determine the prevalence of prolonged post-surgical opioid use, and patient-related factors~     associated with prolonged post-surgical opioid use.~   "
76050|NCT02571530|"~     The purpose of this study is to evaluate the safety of administering a single dose of~     trastuzumab into the artery for the treatment of brain metastasis(es) from HER2/neu positive~     breast cancer.~      This study will try to determine the best tolerated single dosage of trastuzumab administered~     into arteries by gradually increasing the dosage given to participants as the study~     progresses. Early participants will receive a dosage of 1 mg/kg. As more participants enroll~     into the study, this single dosage will be increased at designated levels up to 8 mg/kg, if~     it's determined to be safe to increase.~      Trastuzumab is a type of antibody, which is a protein used by the body's immune system to~     fight against pathogens such as bacteria and viruses. This antibody binds to cell receptors~     known as the HER2/neu tyrosine kinase receptor. These receptors are expressed in certain~     cancer subtypes such as breast cancer. By blocking signaling through this HER2/neu receptor,~     trastuzumab can slow down or stop the over-expression of the HER2/neu protein.~     Over-expression of HER2/neu has been shown to play a role in the development and progression~     of certain types of breast cancer. Therefore, by slowing down or stopping the expression of~     HER2/neu, investigators hope to slow down or stop the growth of metastasis(es) and increase~     the responsiveness to therapy.~   "
76051|NCT02571517|"~     The purpose of this study is to to demonstrate that a 7-day course of systemic~     glucocorticoids decreases the inflammatory activity of moderate or severe bronchiolitis in~     paediatric patients compared to the standard treatment. To evaluate the morbidity (regarding~     to the clinical course: Intensive Pediatric Unit Care unit (PICU) admission, mechanical~     ventilation, ionotropic support, nosocomial infection, rescue therapy for respiratory~     failure; duration of PICU stay and hospitalization; and exitus) between the treatment and the~     control groups.~   "
76052|NCT02571504|"~     Cognitive deficits in HIV reflect degraded brain network functioning that may be amenable to~     remediation through cognitive training. In this sub-study, we will make use of~     Plasticity-based Adaptive Cognitive Remediation (PACR), which applies well-understood~     techniques derived from brain plasticity and implicit/procedural/perceptual learning to~     improve the speed and accuracy of information processing, with exercises that are designed to~     drive generalized improvements. Simultaneously, these exercises heavily engage~     neuromodulatory systems to re-establish their normal control over learning and memory. As an~     individual restores these degraded abilities through intensive procedural learning, the~     encoding of naturalistic information significantly improves, and all resulting declarative~     memory and cognitive functions based on the quality of that incoming information necessarily~     improve as well, leading to improvement that generalizes beyond the trained tasks.~      A subset of 80 HIV+ individuals will undergo eight weeks of PACR to determine its feasibility~     and appropriateness for people with mild cognitive difficulties related to HIV infection. The~     results of this study are expected to be pivotal in generating data to create an optimal~     training program aimed at stabilizing or improving brain function in HIV infected individuals~     experiencing cognitive decline.~   "
76053|NCT02571491|"~     Comparison of the Efficacy of ketamine measuring the total consumption of morphine in~     pediatric patients with idiopathic scoliosis~   "
76054|NCT02571478|"~     The psychological health of military members is a critical element of force health protection~     and readiness. Frequent deployments and high operations tempo at home strain the~     relationships and families of today's military more than ever before (e.g., Karney & Crown,~     2007). Since 2001 the likelihood of divorce in the Air Force increased with the number of~     days that Airmen were deployed (Karney & Crown, 2007). Distressed relationships not only~     adversely affect members' adjustment and readiness (e.g., Hoge et al., 2006) but also are~     centrally implicated in suicides (i.e., relationship problems are the precipitating event in~     51% of Air Force suicides, Kindt, 2009) and domestic violence (Pan, Neidig, & O'Leary, 1994).~     Unfortunately, traditional sources of marriage counseling available to service members are~     largely underutilized. The MC brings a fresh perspective that helps normalize relationship~     help-seeking and in turn reach larger numbers of distressed couples early. The partnering of~     MC and integrated primary care appears to be an ideal combination of behavioral health~     innovations that has the potential to measurably enhance relationship health for the military~     services.~   "
76055|NCT02571465|"~     To overcome the limited accuracy of functional hemodynamic parameters such as stroke volume~     and pulse pressure variation (SVV and PPV) during spontaneous breathing, a Passive Leg~     Raising (PLR) manoeuvre has been suggested as a reliable predictor of fluid responsiveness.~      Aim of this study was to evaluate fluid responsiveness using SVV, PPV and PLR during the~     transition from controlled to spontaneous breathing in cardiac surgery patients~   "
76056|NCT02571452|"~     The purpose of this study is to determine whether a brief, behavioral treatment for insomnia~     is effective in addressing social and occupational functioning and overall health among~     Veterans with insomnia disorder.~   "
76057|NCT02571439|"~     The TAP is a space between the muscle layers of the abdominal wall that houses nerves~     supplying the abdominal skin. Injecting the local anesthetic ropivacaine into this space will~     block these nerves and prevent pain following c-section. The investigators will compare two~     different approaches to injecting the local anesthetic in this space. Conventionally, the~     block is done after surgery is completed and the abdomen is closed. The anesthesiologist~     introduces a needle through the abdominal wall skin under ultrasound guidance to reach the~     TAP space and the drug is injected. Since the TAP layer is one of the deeper layers of the~     abdominal (belly) wall and is closer to the inside of the abdomen than to the outside (skin),~     injecting from the inner aspect of the abdominal wall during the surgery is easier and~     quicker to perform than the conventional block and does not require ultrasound guidance as~     there is no risk of injury to abdominal organs like the liver.~      With this research the investigators attempt to prove that surgically administered TAP blocks~     take 25% less time to perform compared to the conventionally administered TAP block for post~     cesarean section pain relief. Surgical TAP blocks are also more cost-effective as in addition~     to reduced OR time, they are safer and do not require skilled operator and specialized~     equipment. Secondary outcomes will include total time spent in the Operating room, presence~     and severity of postoperative pain, time to first request for pain medication, total~     postoperative narcotic consumption in 48 hours after surgery and side effects.~   "
76061|NCT02571387|"~     The purpose of this study is to evaluate the efficacy of a daily 12-month computerized~     mindfulness-based intervention in obese patients diagnosed with Binge Eating Disorder (BED)~     on: impulsive eating, motivation toward exercise, and weight loss.~   "
76063|NCT02571361|"~     Trial name: PAracetamol and NSAID in combination: A randomised, blinded, parallel, 4-group~     clinical trial~      Trial acronym: PANSAID~      Background: Effective postoperative pain management is essential for the well-being and~     rehabilitation of the surgical patient. No gold standard exists after total hip~     arthroplasty (THA) and combinations of different non-opioid medications are used with~     virtually no evidence for additional analgesic efficacy compared to monotherapy.~      Objectives: The objective of this trial is to investigate the analgesic effects and safety of~     paracetamol and ibuprofen and their combination in different dosages after THA.~      Intervention: Patients are randomised to 4 groups: A) paracetamol 1 g x 4 and ibuprofen 400~     mg x 4; B) paracetamol 1 g x 4 and placebo (ibuprofen); C) placebo (paracetamol) and~     ibuprofen 400 mg x 4; and D) paracetamol 0,5 g x 4 and ibuprofen 200 mg.~      Design: Placebo controlled, parallel 4-group, multicentre trial with adequate centralised~     computer-generated allocation sequence and allocation concealment with varying block size and~     stratification by site. Blinding of assessor, investigator, caregivers, patients, and~     statisticians.~      Sample size: 556 eligible patients are needed to detect a difference of 10 mg morphine the~     first postoperative day with a standard deviation of 20 mg and a type 1 error rate of 0,004~     (two-sided) and a type 2 error rate of 0,10.~   "
76064|NCT02571348|"~     This study is intended to investigate the optimum interval between micro-osteoperforations to~     accelerate orthodontic tooth movement. Overall, the investigator will be comparing the rate~     of tooth movement between micro-osteoperforated site and non micro-osteoperforated site.~     Next, the investigator will be comparing the rate of orthodontic tooth movement for~     micro-osteperforation performed at 4, 8 and 12 weeks' intervals. In addition, the~     investigator will be evaluating the pain intensity and impact of pain on quality of life~     during different intervals of micro-osteoperforations at 4, 8 and 12 weeks. Finally, the~     investigator will be comparing the rate of orthodontic tooth movement between maxilla and~     mandible.~      The significance of the outcome is to determine optimum recommended interval for~     micro-osteopeforation which can be used to accelerate orthodontic tooth movement. By finding~     out the optimum interval, the investigator can come with a recommended interval of~     micro-osteoperforation which can be used routinely in patients to fasten orthodontic tooth~     movement.~   "
76065|NCT02571335|"~     Multiple Sclerosis (MS) is a chronic immune-mediated disease of the central nervous system,~     accompanied by varying inflammatory manifestations, demyelinization and axonal loss. With~     chronic progressive or relapsing-remitting disease onsets persons with MS (pwMS)~     progressively develop impaired functional capacity and show reduced physical activity and~     cognitive decline compared to healthy controls. The primary aims of rehabilitation in pwMS~     are therefore to increase levels of activity and participation leading to increase~     independence of the participants. In general exercise ranges from passive physiotherapy-based~     interventions to submaximal endurance training sessions. Current recommendations advise pwMS~     that exercise should be matched with the individual performance capacities. Exercise training~     in pwMS then has the potential to target and improve many components outlined in the~     ICF-model.~      Cytokines and neurotrophic factors have received increased attention in MS research and~     addressed the brain-derived neurotrophic factor (BDNF) as an important mediator of neuronal~     regeneration linking the effects of exercise with MS pathogenesis. Data show positive~     connections between elevated neurotrophin concentrations, induction of neuroplasticity,~     recovery of the motor and cognitive functions and the applied training intensities.~     Similarly, intensive and progressive exercise bouts seem to have greater benefits on~     cardiorespiratory fitness and maximum voluntary strength in elderly and seniors with~     dementia. Therefore, specific exercise prescriptions may be necessary for targeting the~     specific impairments also in pwMS.~      This study aims to evaluate two different training modalities (intensive versus normal) in~     pwMS. It is expected that both modalities will improve cardiorespiratory fitness and~     cognitive functions in pwMS. Based on the findings that higher training intensities~     facilitate greater benefits, it is expected that pwMS will tolerate the intensive training~     intensities and show positive connections to elevated neurotrophin concentrations.~      The results will to help to clearer understand the benefits of each type of exercise conveyed~     for pwMS and will assist in the development of patient-specific exercise prescriptions.~   "
76066|NCT02571322|"~     The purpose of the study is to determine the effect of whole-body vibration (WBV) on body~     composition, physical fitness, and quality of life.~   "
76067|NCT02571309|"~     Primary aim: Evaluating the effect of Asthmatuner on patients´ self-reported asthma control~     test (ACT/C-ACT)compared with conventional asthma management.~      Secondary aim: Evaluating patients´ health-related quality of life (HR-QoL) medical adherence~     by using Asthmatuner compared with conventional management.~      Total sample size: Stratified study population consisting of 43 females and males with~     diagnosed asthma at the age of at least 6 years pediatric specialist care and 43~     females/males in primary care.~      Study design: This is a multi-centre, blinded, randomized controlled, cross-over trial over~     to at least 16 weeks.~      Subjects: Two stratified groups of participants with uncontrolled asthma will be recruited;~     (1) children and adolescents from Astrid Lindgren's Children's Hospital, Karolinska~     University Hospital, and (2) adolescents and adults from the primary health care sector in~     Stockholm, Sweden. The asthma control test (ACT/C-ACT) will be applied for evaluation of~     asthma control, a score less than 20 will be required for inclusion.~      Intervention: Asthmatuner is an app supporting self-management evaluating symptoms and lung~     function with external spirometry. The app gathers the information to define patients´ asthma~     control. Subsequently, Asthmatuner provides the patient with a treatment recommendation based~     on the individual treatment plan.~      Procedures: Participants are randomized (1:1) into the one of two-arms of asthma~     self-management with Asthmatuner - conventional or conventional - Asthmatuner. Questionnaires~     will collect information about asthma control, HR-QoL, Medicine adherence report scale (MARS)~     and history of medical health concerning health care utilization and personal costs and~     income.~      Analysis: The study hypothesis will be tested by examining difference in patients´ change in~     asthma control (ACT/C-ACT) and HR-QoL (PAQLQ/Mini-AQLQ). Results will be summarized at each~     management period as mean scores and analysed by paired t-tests.~   "
76068|NCT02571296|"~     This is a randomized, double-blind, placebo-controlled study.~   "
76069|NCT02571283|"~     A prospective, randomized control study will be conducted to compare postoperative pain~     control in a series of patients treated with either:~        1. a local cocktail.~        2. a local cocktail plus Exparel.~        3. marcaine plus Exparel prior to wound closure following knee arthroplasty.~   "
76070|NCT02571270|"~     Purpose: Physical exercise exerts favorable impact on functional capacity (FC) and quality of~     life (QL) in patients with heart failure (HF). It is believed that the combined aerobic and~     resistance physical training (CPT) supervised by physical educator is better than only~     prescription of unsupervised exercise. The aim of this study is to compare the effects of a~     CPT program on the FC and QL of HF patients with reduced ejection fraction (HFREF) with the~     practice medical routine prescription of regular physical activity and correlate these~     findings with clinical and echocardiographic variables.~      Methods: A longitudinal prospective study included 28 consecutive HFREF patients randomly~     divided in two age- and gender- matched groups: Trained Group (TG, n = 17), patients~     undergoing 12 weeks of supervised CPT and Non Trained Group (NTG, n = 11), patients receiving~     only medical prescription to practice regular physical exercise. All patients were submitted~     to clinical evaluation, transthoracic echocardiography, Cooper walk test and QL questionnaire~     before and after the study protocol. Student t test or Mann-Whitney test were performed for~     groups comparison and correlation tests for the same group variable associations.~   "
76072|NCT02571244|"~     The study is a preliminary research aimed to compare the effectiveness of motivational~     interview (MI), Personalized text messages (TM) and usual care for outpatients, with focus on~     smoking cessation as the main outcome. Smokers patients receive brief interventions and~     nicotine replacement therapy during the hospitalization. After hospitalization discharge~     smokers will be allocated in a intervention or control arm. In the first and third months,~     after randomization, the patients will be contact to smoke abstinence assessment.~   "
76073|NCT02571231|"~     The trial is a pilot study performed in the NICU's at Oslo University Hospital and Haukeland~     University Hospital preparing a multi-center randomized, controlled unblinded cross-over~     study, comparing high frequency ventilation (HFV) with and without volume guarantee (VG).~   "
76074|NCT02571218|"~     In this study, the investigators aim to identify and characterize, by means of an EnSite~     Velocity Research Software, the electrophysiological characteristics of substrates that~     sustain AF in patients with persistent AF and to test whether ablation of such~     patient-specific substrates might improve the acute and long-term success of conventional~     catheter ablation therapy.~   "
76075|NCT02571205|"~     Observational study of clinical outcomes for testosterone treatment of pubertal delay in~     Duchenne Muscular Dystrophy is a single centre observational study that aims to follow the~     progress of 20 adolescents with Duchenne Muscular Dystrophy (DMD) and delayed puberty who are~     treated by the Newcastle muscle team, as they are treated with testosterone to induce~     puberty. The participants will all be treated with the standard stepwise regimen of~     testosterone injections every 4 weeks and data will be collected to help determine the~     effectiveness and tolerability of the current treatment regimen. The investigators will use~     the data to explore the effect of testosterone on pubertal development, growth, muscle~     strength and function, bone mineral density and body composition and characterise any side~     effects. Semi-structured interviews will also be carried out to learn the boys' views on the~     tolerability of the regimen. The study will last up to a maximum of 27 months in total for~     each participant, but may be less if they are happy with pubertal development before this~     time. It is important to do this study because from the investigator's limited experience in~     this group, testosterone treatment seems to be well liked and tolerated but the best~     treatment regimen to use remains unknown and there is no current consensus. It is not~     currently part of the standard of care in DMD but it would be important to include it if this~     study can show that it is an effective treatment for pubertal delay.~   "
76076|NCT02571192|"~     The purpose of this study is to determine how SHP626 is absorbed and excreted from the body~     in healthy males.~   "
76077|NCT02571179|"~     Physiological changes during pregnancy are known to affect the pharmacokinetics of many~     drugs. Intranasal fentanyl is an interesting option for obstetric analgesia, but its use in~     pregnant patients has not been established. The investigators studied pharmacokinetics of~     intranasal fentanyl in labouring women and to subsequently evaluate the maternal and fetal~     safety after administration.~   "
76078|NCT02571166|"~     The purpose of the study is to determine the safety of HSV529 vaccine in healthy volunteers~     with HSV infection and to determine if administration of the HSV529 vaccine increases the~     immune response in genital skin.~   "
76079|NCT02571153|"~     There are evidences that intraoperative administration of low doses of ketamine may~     contribute to control the postoperative pain by acting on the N-methyl-D-aspartate (NMDA)~     channel, reducing the effects related to the tolerance and hyperalgesia induced by opioids.~     This study aims to evaluate the effects of administration of this agent not only as an~     analgesic but also its role in the quality of recovery from anesthesia, which includes~     observation of emotional, psychological and physical aspects. Patients who were scheduled to~     undergo total intravenous anesthesia (TIVA) for laparoscopic cholecystectomy will be enrolled~     in this clinical study. After induction of anesthesia, patients will receive one of three~     solutions according to the randomly selected group: ketamine 0,2 mg/kg; ketamine 0,4 mg/kg or~     saline. In the recovery room and on the ward, data related to the presence of pain, analgesic~     consumption, the incidence of nausea and vomiting, dizziness or hallucinations will be~     recorded. The next day, the quality of recovery will be evaluated by application of the~     questionnaire QoR40 (Quality of Recovery Questionnaire-40).~   "
76080|NCT02571140|"~     This study will have one stage consisting of multiple treatment visits. The study is designed~     to assess the safety and bioavailability of Entera's oral PTH(1 - 34) in adult male healthy~     volunteers in various formulation. The study is also designed to assess the reproducibility~     of pharmacokinetic profiles with various formulations.~   "
76081|NCT02571127|"~     Primary: Evaluation of improved vaginal moisture in postmenopausal women.~      Secondary: the improvement of symptoms resulting from the dryness Rating (VHI), evaluation of~     the decrease in vaginal pH, assessment of Sexual Function Index female (FSFI), evaluation of~     adherence to study treatment by patient diary, assessing the acceptability of the product and~     subjective assessment of the patient as the itching and stinging / burning, beyond the safety~     assessment.~   "
76082|NCT02571114|"~     A single site, blinded, randomized, controlled study designed to examine the glycemic and~     metabolic response of frozen yogurt containing Saskatoon berry powder in healthy males and~     females.~   "
76083|NCT02571101|"~     The purpose of this study is to evaluate the safety and efficacy of on-demand therapy with~     CDFR0812-15/25mg and CDFR0812-15/50mg compared to on-demand therapy with single-drug~     administration of Clomipramine HCl 15mg in Korean Male Patients Diagnosed with Premature~     Ejaculation~   "
76084|NCT02571088|"~     Sickle cell disease (SCD) is the most frequent inherited disease in the world. Literature~     reports that SCD patients display intolerance to exercise, important muscle weakness and~     profound remodeling of skeletal muscle including amyotrophy and rarefied microvascular~     network.~      Because strenuous exercise induces acidosis, hemorheological alterations, endothelial~     activation and oxidative stress, it constitutes a potential triggering factor of sickling and~     vaso-occlusive crisis. As a consequence, physical activity is usually discouraged in patients~     with SCD. However, moderate and regular physical activity seems to be not only safe but also~     beneficial for SCD patients.~   "
76085|NCT02571075|"~     The purpose of this study is to determine if auricular acupuncture significantly reduces~     post-operative pain in comparison to the standard of care. Post-operative pain score will be~     collected by subject self-report of pain according to the Numerical Rating Scale (NRS) (0= no~     pain, 10 = worst imaginable pain) up to 10 days post-operation.~   "
76086|NCT02571062|"~     Phase 1 bioequivalence (BE) study. This study is for regulatory purpose to determine BE of~     the tablet formulation used in the clinical trials and the final marketed tablet formulation~     under fed condition.~      The study will be an open-label, 2-treatment, 2-sequence, 4-period, single-dose, replicate~     crossover study under fed condition. The 4-period sequences for the replicate design will be~     TRTR and RTRT, where R designates the reference formulation and T the test formulation.~     Subject will be allocated randomly to one of the two sequences of treatments according to the~     randomization list.~   "
76087|NCT02571049|"~     Pilot study to compare the efficacy and safety of two strengths of injections of subcutaneous~     DFN-11 in subjects with rapidly escalating migraine headaches.~   "
76088|NCT02571036|"~     This is a Phase 1, open-label, first-in-human (FIH) dose-escalation study designed to~     evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and~     preliminary antitumor activity of DCC-2618, administered orally (PO), in adult patients with~     advanced malignancies. The study consists of 2 parts, a dose-escalation phase and an~     expansion phase.~   "
76089|NCT02571023|"~     The purposes of this study are as follows:~        1. to collect the largest epidemiological data of skull base trauma and analyze the related~          influence factors of mortality and morbidity.~        2. to establish a set of standard classification methods of skull base trauma and to~          establish a standard rating scale for each type of trauma.~        3. to select optimized conservative and surgical treatments of skull base trauma and to~          compare the therapeutic effect between microscope surgery and neuroendoscopic surgery.~        4. to clear the epidemiological characteristics of the skull base trauma combined with~          paroxysmal sympathetic hyperactivity.~   "
76090|NCT02571010|"~     This study aims to demonstrate that somatosensory rehabilitation of pain associated with~     static mechanical allodynia has superior efficacy over placebo treatment as well as over~     spontaneous changes.~   "
76091|NCT02570997|"~     This is a double-blind, placebo controlled, ascending dose, multi-cohort trial. The study~     will be conducted in two phases: a single ascending dose (SAD) phase Part A, followed by a~     multiple ascending dose (MAD) phase Part B. In Part A, subjects will receive one dose of~     study drug. In Part B, subjects within a cohort will receive the same dose daily for 14 days.~     In both parts, sequential cohorts will be exposed to increasing doses of CT1812 in order to~     identify the maximum tolerated dose (MTD).~   "
76092|NCT02570984|"~     This trial is a randomized, double-blind, placebo controlled trial designed to test whether~     two years treatment of preschool children aged 2-3 years of age at high risk for asthma with~     omalizumab (anti-IgE) for two years will prevent the progression to childhood asthma, as~     reflected by a reduction in the prevalence of active asthma in the Final 12 months during 2~     year observation period off study drug.~   "
76093|NCT02570971|"~     Ciguatera poisoning, caused by the ingestion of ciguatoxin-containing fish, is a global~     public health concern. In the US, the vast majority of ciguatera poisonings occur in Florida,~     followed by Hawaii and California. Equipoise exists in the medical literature regarding the~     effectiveness of mannitol therapy in treatment of ciguatera poisoning. While there are many~     case reports attesting to its utility, the only randomized control trial (RCT) comparing~     mannitol therapy with supportive care failed to show any significant benefit from mannitol~     treatment for a variety of clinical outcomes. Investigators therefore propose a second,~     larger RCT to test this question.~   "
76094|NCT02570958|"~     Lung cancer is the leading cause of cancer deaths worldwide. However, if diagnosed at an~     early stage (tumor <2 cm), lung cancer is highly curable with a 5-year survival rate greater~     than 80% after surgical resection. Screening tests have made it easier to identify small lung~     tumors. However, these tumors are often not visible to the naked eye, and surgeons cannot~     feel them, making them difficult to precisely locate and remove. For this reason, surgeons~     have become more reliant on image guided surgery for the removal of these tumors.~      The standard of care for locating and removing small lung tumors is microcoil-guided~     video-assisted thoracoscopic surgery (VATS). This is a two-step procedure performed by two~     separate physicians.~        -  First, patient is taken to radiology suite and radiologist inserts a microcoil near the~          lung tumor~        -  Second (usually occurs a few hours later), patient is taken to operating room; a surgeon~          uses an x-ray arm to find the microcoil within the lung and remove it surgically.~      A pathologist reviews the resected tissue to make sure that the tumor and the microcoil were~     both removed. Until this evaluation, the surgeon does not know whether the tumor has been~     removed or not. While this method is safe, it is time consuming, uses staff resources, and~     requires bulky equipment to complete.~      In this study, we plan to develop and test a new method of identifying and removing small~     lung tumors. This procedure is called Electromagnetic Navigational Bronchoscopy (ENB) Robotic~     Indocyanine Green Guided Surgery (RIGGS) or ENB-RIGGS for a short name. The purpose of this~     study is to test the safety and reliability of the ENB-RIGGS surgery in the form of a pilot~     study.~      ENB-RIGGS surgery is done in the operating room by a surgeon under general anesthetic.~     ENB-RIGGS begins by creating a 3-D GPS map of the lung which guides the surgeon directly to~     the tumor. A fluorescent green dye called indocyanine green is then injected into the tumor,~     and when viewed by the special robotic camera the tumour will fluoresce with a green hue~     allowing the surgeon to easily see the tumour. The surgeon then uses the robot to remove the~     tumor and surrounding tissue. The lung tissue specimen will be evaluated immediately by a~     pathologist.~   "
76095|NCT02570945|"~     The study population will consist of all elderly (65 and older) patients hospitalized at the~     Centre hospitalier universitaire de Sherbrooke. The patients who present a~     pharmacotherapeutic problem will be randomly allocated between intervention and control~     groups. Practically, the relevant data will be extracted from the Electronic Medical Record~     (EMR) on a daily basis and analysed by a Computerized Alert System (CAS) to identify~     pharmacotherapeutic problems. These problems will be analysed a pharmacist specialised in~     geriatrics to determine their clinical relevance and the modifications that can be made.~     Clinically relevant pharmacotherapeutic problems will be discussed by the pharmacist and~     treating physician to establish the changes needed to optimize drug therapy. A geriatrician~     will also be available to assist the pharmacist in his initial assessment for particularly~     complex cases. For control patients, a CAS analysis will be conducted to identify patients~     with a pharmacotherapeutic problem but there will not be a formal discussion amongst the~     health care providers (usual care) and the physicians of the control group will provide usual~     care to their patients. The investigators believe that it is ethical to provide usual care to~     the control group since the beneficial impact on patients outcomes of the investigators'~     intervention has not been demonstrated.~      Pharmacotherapeutic problems were prioritized by the CHUS Elderly Adapted Care-medication~     committee and are based on the Beers criteria with an emphasis on drugs involved in the~     development of delirium. Selected pharmacotherapeutic problems are: 1) For patients 75 and~     older: i) taking a PIM; ii) concomitant use of 4 or more drugs from a list of drugs active at~     the CNS; iii) positive test for delirium with a PIM; 2) For patients 65 years and older: i)~     taking levodopa (Parkinson indicator) with a PIM; ii) taking cholinesterase inhibitor or~     memantine (indicators of dementia) with a PIM. The use of levodopa, a cholinesterase~     inhibitor or memantine are frailty indicators.~   "
76096|NCT02570932|"~     The purpose of this study is to analyze the potential clinical efficacy of intrathecal~     administration, in the subarachnoid space, of in vitro expanded autologous adult bone marrow~     mesenchymal stem cells in the treatment of patients with established chronic spinal cord~     injury (LEM).~   "
76228|NCT02569216|"~     An electrical-inhibition (EI) uterine pacemaker device similar to an electrical heart~     pacemaker delivers a weak electrical current to the human uterus during active preterm labor~     to rapidly and safely inhibit the unwanted premature uterine contractions and possibly a~     preterm birth.~   "
76097|NCT02570919|"~     The present study evaluates clinical outcomes and treatment-related toxicity following~     definitive ultra-high dose external beam radiotherapy delivered with two different regimens~     in patients with intermediate-risk adenocarcinoma of the prostate. Modern computer-driven~     technology enables the implementation of ultra-high hypofractionated Image-Guided~     Radiotherapy (IGRT) safely.~      Prostate cancer patients classified according to the current National Comprehensive Cancer~     Network (NCCN) guidelines as intermediate risk (biopsy Gleason score of 7 and/or Prostate~     Specific Antigen (PSA) level >10 and ≤20 ng/mL and/or Stage T1, T2a, T2b or T2c) are eligible~     for this study.~      Patients will undergo IGRT with volumetric intensity-modulated arc radiotherapy (VMAT) with~     state-of-the-art treatment-planning and quality assurance procedures. Emphasis is placed on~     normal tissue sparing and delivery accuracy via the use of devices that ensure stability and~     beam location reproducibility. A rectal balloon with air filling will be used for prostate~     target immobilization and anatomical reproducibility, while a urethral catheter loaded with~     beacon transponders will be used to ensure set-up reproducibility and online target tracking.~     Previously untreated patients with intermediate-risk prostate cancer will be prospectively~     randomized to receive either 45 Gy in five fractions of 9 Gy each vs. 24 Gy in a single-dose.~      Patients will be followed at one month post-treatment and every 3 months for up to 12 months~     (+/- 4 weeks) and every 6 months thereafter. Acute and chronic toxicity evaluations will~     focus on urinary, rectal and sexual functions and will be assessed through validated~     questionnaires. Serum PSA values will be regularly acquired during follow-up. A~     multiparametric MRI will be performed at baseline, 6, 12 and 24 months following~     intervention. Additionally, a post-treatment diffusion-weighted MRI (DW-MRI) will be~     performed within 15 minutes of the first treatment, to measure early physiologic changes,~     such as perfusion and ischemia, that may correlate with clinically relevant end-points.~     Post-treatment prostate needle biopsies will be obtained at 24 months to evaluate pathologic~     response to therapy. The study will be continuously monitored for a minimum of 5 years. In~     the event unexpected severe (grade ≥3) toxicities are observed in any one of the treatment~     arms, the study will be terminated according to the stopping rule >3/first 15 patients.~   "
76098|NCT02570906|"~     This study will evaluate the performance of the Zephyr BioPatch in measuring heart rate,~     respiration rate, posture, and activity level compared to reference devices in healthy adult~     subjects during a variety of situations including hospital room movements, talking, and a~     short bout of exercise.~   "
76099|NCT02570893|"~     This is a multicenter, randomized, open-label, phase III trail comparing adjuvant~     chemoradiotherapy (Paclitaxel and carboplatin) to adjuvant radiotherapy in patients~     undergoing radical esophagectomy for pathologic lymph node positive esophageal squamous cell~     carcinoma.~   "
76100|NCT02570880|"~     This study evaluates the impact of dough fermentation times on the glycaemic index of the~     ensuing breads.~   "
76101|NCT02570867|"~     Structural and functional brain changes of primary open-angle glaucoma patient will be~     examined with fMRI. POAG patients and control group were examined with 3.0T magnetic~     resonance imaging. The gray matter, white matter and cerebrospinal fluid volume images will~     be obtained and analysed.~   "
76102|NCT02570854|"~     The study will assess the safety, tolerability and efficacy of CSJ137 in chronic hemodialysis~     patients. It is hypothesized that treatment with CSJ137 may improve the level of hemoglobin~     in patients on chronic hemodialysis with iron-restricted anemia while reducing the need for~     dosing with erythropoietin and intravenous iron in these patients.~   "
76103|NCT02570841|"~     Aim of the study is to determine heat pain thresholds (HPT in °C) and cold pain thresholds~     (CPT in °C) during topical capsaicin 8% application, and mechanical pain thresholds (MPT in~     g) immediately after to find out the exact skin temperature by which capsaicin initiates the~     application pain (heat pain threshold, HPT in °C) but also the temperature by which capsaicin~     does not yet trigger a cold pain (cold pain threshold, CPT in °C). Moreover the investigators~     want to find out the mechanical pain threshold in g from topical capsaicin and to verify a~     prolonged effect of capsaicin on the pain thresholds.~   "
76104|NCT02570828|"~     This is a study to evaluate thermal imaging as a technology to monitor the normal clearing of~     amniotic fluid from healthy newborns and newborns suspected of having a condition called~     transient tachypnea of the newborn, or TTN. Thermal images are taken using an imaging device~     that attaches to an iPhone. This device, commercially known as FLIR ONE, creates a~     non-identifiable image based on the heat pattern of an object. In this case, the object is a~     child's chest and back. It does not emit any radiation like an x-ray does.~   "
76105|NCT02570815|"~     Lungs are made up of individual lobes. When a lung cancer tumour is detected in one of these~     lobes, surgeons typically perform a Lobectomy. A Lobectomy is the surgery most commonly done~     to treat early-stage lung cancer and requires removal of an entire lobe of the lung, which~     removes a large amount of lung tissue For patients with small tumours saving as much healthy~     lung tissue as possible is important. Each lobe of the lung has smaller sections called~     segments. When a lung cancer is in one of these segments, it is possible to remove that~     segment, without removing the entire lobe. This surgery is called a segmentectomy. Compared~     to a lobectomy, a segmentectomy saves a larger amount of healthy lung tissue.~      With the advances in screening technology for lung cancer tumours, an increasing amount of~     very small lung cancer tumours are being found, and the demand for segmentectomy is~     increasing. A segmentectomy is a hard surgery to perform robotically because it is difficult~     to view the tissue lines that separate each segment within the lobe. As a result, it is~     difficult for the surgeon to see exactly which pieces of tissue should be removed. Because of~     these challenges, many patients having robotic surgery will have a lobectomy, even if a full~     lobectomy is not needed.~      Near-Infrared Fluorescence (NIF) using indocyanine green (ICG) fluorescent dye is a recent~     advancement in the robotic platform of robotic surgery. The surgeon will view the CT scan to~     determine which segment the tumour is located in. Once identified, the surgeon will isolate~     the segment by cutting off the blood supply to that segment. Then ICG will be injected into a~     vein. It is expected that the entire lung, except the isolated segment, which will remain~     'dark' as it was isolated from blood supply, will fluoresce, giving off a green hue when~     viewed with the da Vinci Firefly camera. The surgeon will identify 'dark' segment, and will~     remove it. A pathologist will examine the excised tissue to ensure that the tumour was~     removed in its entirety. Once confirmed, the surgeon will end the procedure. If the~     pathologist determines that the segment removed did not contain the entire tumour, then the~     surgeon will perform a routine lobectomy. This ensures patient safety and confirms that all~     participants will have the entire tumour removed from their lung.~   "
76106|NCT02570802|"~     The purpose of this clinical trial is to assess normal values of the cross-sectional area of~     peripheral nerves and nerve roots in children and adolescents between 2 and 18 years.~   "
76107|NCT02570789|"~     The purpose of this study is to assess whether certain metabonomics and/or lipidomics~     features in correlation with pharmacokinetics before, during and after treatment with~     sunitinib or pazopanib in first line can predict toxicity and efficacy of sunitinib or~     pazopanib in metastatic clear cell renal cell carcinoma patients.~   "
76108|NCT02570776|"~     The prevalence of H. pylori infection in Pakistan is unknown and investigators want to assess~     it in dyspeptic patients utilizing UBT. At the same time investigators want to validate UBT~     sensitivity and specificity in Pakistani patients~   "
76109|NCT02570763|"~     The current study aims to examine the safety and feasibility of utilizing tDCS to enhance~     affect-laden episodic memory consolidation among adults with co-occurring alcohol use and~     anxiety disorders who have recently undergone detoxification as a step toward the~     translational clinical application of this approach.~   "
76110|NCT02570750|"~     The main purpose of this study is to assess the effect of smoking status on the success of~     Etanercept therapy in patients with moderate-to-severe psoriasis.~   "
76111|NCT02570737|"~     The RELAHP registry is a Latin-American multinational, multicenter, prospective observational~     registry-type cohort study, which pretends to identify clinical characteristics, clinical~     course, management and outcome of all forms of pulmonary hypertension (PH).~      All consecutively consented patients newly diagnosed with WHO Group I-V PH according to~     specific hemodynamic criteria on right heart catheterization at the participating centers~     will be enrolled. Patients will be followed six-monthly for a minimum of five years from the~     time of enrollment.~   "
76112|NCT02570724|"~     The injection of autologous blood Blood Patch (BP) into the epidural space is the standard~     treatment for headache associated with intracranial hypotension. It provokes cerebral~     vasoconstriction. It is cons-indicated in a number of situations (HIV positive, fever,~     sepsis, leukemia). The purpose of this study is to evaluate another technique using a patch~     made by injecting an epidural hydroxyethylstarch solution (HES 130, 0.4, 6%) instead of blood~     patch. This alternative technique is simple to implement and does not have some of the~     specific blood pressure contra-indications. The study aims at comparing the Blood Patch~     group versus the HES Patch in terms of clinical efficacy , tolerance, satisfaction of the~     anesthetist, ease of implementation and effect of the injection of epidural anesthesia on~     cerebral blood flow within 24 hours.~   "
76113|NCT02570711|"~     To evaluate the Safety and efficacy of ACP-196 and nab paclitaxel/gemcitabine in subjects~     with metastatic pancreatic cancer using standard response criteria~   "
76114|NCT02570698|"~     The primary objective of this study is to collect feces from premature infants over a five~     weeks period to characterize its composition. Metabolomics, Proteomics, Genomics and~     Microbiome analyses and cell-based assays will be performed to identify individual components~     present in feces, which may contribute to the onset of irritation in the diapered area of~     premature infants.~   "
76115|NCT02570685|"~     This randomized controlled study will examine the effects of different interpersonal~     gratitude journals compared to a neutral control journal on psycho social outcomes.~   "
76116|NCT02570672|"~     Frailty is a geriatric syndrome which leads to poor health outcomes in older adults, such as~     falls, disability, hospitalization, institutionalization, and death. Due to the dramatic~     growth in the U.S. aging population and the health care costs associated with frailty~     (estimated at more than $18 billion per year), frailty is a major health care problem. There~     has been little research into potential pharmacologic interventions that would delay or~     reduce the incidence of frailty. Thus, the major goal of this study is to test metformin as a~     novel intervention for the prevention of frailty. The investigators propose that~     diabetes/insulin resistance and inflammation are major contributors to frailty, and that the~     use of metformin to modulate diabetes/insulin resistance and inflammation will prevent and/or~     ameliorate the progression of frailty.~   "
76117|NCT02570659|"~     A randomized controlled trial (RCT) to investigate the effect of a information video,~     consisting of a multiprofessional team, on patients with acute Whiplash Associated Disorder~     (WAD).~   "
76118|NCT02570646|"~     Using a single-arm trial design, this study will examine the feasibility and acceptability of~     evaluating QuitAdvisorDDS, a clinical decision support software application designed to~     facilitate implementation of evidence-based tobacco treatment interventions into the dental~     setting. The study will examine the feasibility and acceptability of evaluating the impact of~     the QuitAdvisorDDS tool on patient outcomes related to tobacco use and cessation attempts as~     well as provider knowledge, attitudes, and practices regarding tobacco treatment.~     Practitioners (dentists and hygienists) will complete surveys at baseline and follow-up,~     while patients will complete surveys at baseline and 1-month follow-up. An embedded substudy~     will also evaluate the feasibility and acceptability of collecting biospecimens (saliva) to~     serve as biochemical verification of smoking status.~   "
76119|NCT02570633|"~     The main objective of the study is to evaluate ginger efficacy as an prophylactic treatment~     of migraine.~   "
76120|NCT02570620|"~     Study of the contribution of ultrasound measurements of the uterine cervix related to the~     calculation of Bishop score. Evaluation of the period between cervical induction and~     delivery. Study of ultrasound data to improve the care of these patients requiring induction.~   "
76121|NCT02570607|"~     BNP is a hormone that predicts preoperatively the occurrence of postoperative cardiovascular~     complications. In practice, the problem is that the practitioner don't know the most~     opportune moment for the preoperative sample or what threshold used to classify our patient~     in patients at risk of cardiovascular complication or not at risk.~      The purpose of this study is to determine the best time to dose the preoperative BNP with a~     specific threshold being associated with it allowing the practitioner to assess more~     accurately the post operative cardiovascular risk patients and possibly offer them strategies~     taking different load.~      The BNP will be dosed during the anesthetic consultation and the day of surgery in immediate~     preoperative operating room. Post-operative cardiovascular complications will be collected~     during hospitalization of the patient and by telephone contact on the 28th day, 90th day and~     6th postoperative months.~      The investigator then establish the threshold BNP most informative for both sampling times~     and then compare them to determine the most discriminating dosage and thus the most~     appropriate time for the determination of BNP.~   "
76122|NCT02570594|"~     The aim of the study is to investigate the temporal organization of autobiographical memory~     in patients with schizophrenia. Patients and control participants will be invited separately~     to participate in a 1hour walk in the city of Strasbourg and at the same time, to carry an~     automatic camera around their neck, which is called SenseCam®. Pictures obtained with~     SenseCam® will be later presented to the participants during the session of test. They will~     be asked to determine the chronological order of 12 pictures corresponding to 12 particular~     events of the tour. Then they will be asked to watch the complete sequence of photos from the~     tour and to determine the beginning and ending of the events that have occurred during the~     tour. According to the investigators hypotheses, patients should have difficulty to find out~     the correct chronological order of the photos and to determine the appropriate beginnings and~     endings of the events~   "
76146|NCT02570282|"~     This is a Phase 2, single center, single-dose, double-blind, placebo-controlled, 2-way~     crossover study to evaluate the safety and efficacy of SST-6007 in women with FSAD. A~     sufficient number of participants will be enrolled to yield 30 (approximately 15~     pre-menopausal and 15 post-menopausal) participants to complete the SST-6007/Placebo~     Double-Blind, Dosing Phase of the study (Visit 2 and Visit 3).~   "
76123|NCT02570581|"~     Elderly people often suffer from chronic pathologies and they are given polypharmacy. In case~     of swallowing problems, the drugs are crushed and mixed in food, which alters the taste of~     food and is a cause of anorexia and malnutrition. Gustative side-effects of crushed drugs~     have nether been investigated. The MELA study is a one session hedonic test involving 16~     healthy volunteers. They will score in a blind manner the taste of 10 drugs commonly~     prescribed in nursing homes, crushed in jelly or apple compote. These volunteers will be 8~     food professionals and 8 geriatric care professionals. Thanks to the MELA protocol, they will~     have a unique opportunity to communicate and propose solutions to this neglected aspect of~     malnutrition in elderly populations.~   "
76124|NCT02570568|"~     Our novel technique of pen-torch transillumination (PTI) uses a cheap and easily available~     instrument (Penlite-LP212®, Energizer®, Missouri, USA) to visualize superficial veins~     invisible to the naked eye. The investigators evaluate the efficacy of PTI in improving~     venepuncture success rate (SR) for patients with poor venous access.~      This prospective randomized controlled trial looks at adult patients aged 21 to 90 with~     difficult venous access (history of ≥3 consecutive attempts required for successful~     cannulation during the current admission) requiring non-emergent venepuncture. Patients will~     undergo venepuncture over the upper-limb using one of the following: Conventional~     venepuncture (control); Veinlite® (TransLite®, Texas, USA), a commercial transillumination~     device; PTI. Outcome measures are: successful cannulation within 2 attempts; duration of each~     successful attempt. Fisher's exact and Kruskal-Wallis tests will be performed.~   "
76125|NCT02570555|"~     The strabismus impacts binocular visual acuity and stereoscopy. Thus, driving capacities of~     patients with strabismus may be reduced. The goal of this work is to study the possible~     amelioration of driving ability after strabismus surgery and to compare the driving~     capacities of patients with strabismus to a normal population; Patients will be tested before~     and after strabismus surgery using a driving simulator, binocular visual field and binocular~     visual acuity.~   "
76126|NCT02570542|"~     The purpose of this study is to study the impact of stem cell dose on outcome after~     autologous transplant.~   "
76127|NCT02570529|"~     Pancreatic ductal adenocarcinoma is the fourth cause of death in the Western world. About 40%~     of pancreatic cancer patients were diagnosed as locally advanced unresectable status without~     distant metastasis. Concurrent chemoradiotherapy (CCRT) was a reasonable treatment modality~     for locally advanced pancreatic cancer. However, several adverse events of chemoradiation~     could lead unfavorable treatment results, which included unique gastrointestinal (GI)~     toxicities, such as ulcer and hemorrhage in the stomach and duodenum that are included in the~     radiation field. According to the study in the investigators hospital, 45% of locally~     advanced pancreatic cancer patients treated with CCRT suffered from GI ulcers, and among~     them, 65% of the patients experienced the significant hemorrhage events. Although these GI~     toxicities, the studies for radioprotective agents were limited. Albis® is a newly developed~     drug comprised of ranitidine, bismuth and sucralfate. The investigators will investigate the~     radioprotective effect of Albis® for locally advanced pancreatic cancer patients treated with~     CCRT.~   "
76128|NCT02570516|"~     This study compares two colonoscopy techniques (with Narrow Band Imaging versus with indigo~     carmine chromoendoscopy) in patients having Lynch Syndrome~   "
76129|NCT02570503|"~     This study will evaluate the use of a local injection around the knee (periarticular) during~     total knee replacement (TKR) surgery to see if it reduces postoperative pain levels. The~     injection is a combination of various medications which are thought to reduce pain levels.~      Approximately 128 patients will participate in this study, half of the patients will receive~     this injection during surgery and the other half will receive a saline (salt water)~     injection. Pain scores after the surgery will be compared between the two groups.~      All patients will also receive a long-acting (24 hours) morphine injection during surgery.~      The hypothesis is that those participants receiving intrathecal Duramorph and local~     periarticular injections will have improved pain scores and reduced narcotic use when~     compared with intrathecal Duramorph alone at 48 hours postoperatively.~   "
76130|NCT02570490|"~     Phase 3, randomized, double-blind, multi-center efficacy and safety study to evaluate an oral~     CEM-102 loading dose regimen compared to oral linezolid in the treatment of subjects with~     ABSSSI~   "
76131|NCT02570477|"~     Clostridium difficile infection (CDI) is a leading cause of hospital-associated~     gastrointestinal illness, associated with significant morbidity and mortality and has a high~     burden on health-care system. The incidence of CDI has increased to epidemic proportion~     worldwide over the past decade. Community-acquired CDI, elderly and hospitalized patients~     receiving antibiotics are the main group at risk for developing CDI.~      Currently, the first-line treatment for C. difficile-associated diarrhea includes cessation~     of the antibiotic implicated in the development of CDI, treatment with metronidazole or~     vancomycin and recently Fidaxomicin which is yet to be available in Hong Kong. However,~     disease recurrence is an increasing problem and 20% to 60% of patients experience at least~     one recurrence within a few weeks of completion of antibiotic treatment. Moreover, an~     increasing number of patients who require life-saving emergency colectomy experience~     persistent CDI after surgery. Until recently, an effective treatment against recurrent CDI is~     not available. Generally, repeated and extended courses of vancomycin are prescribed.~      Fecal microbiota transplantation (FMT) defined as infusion of feces from healthy donors to~     affected subjects has attracted great interest in recent years and is now recommended as the~     most effective therapy for CDI not responding to standard therapies. Systematic reviews of~     prospective trials, case series and one randomized controlled trial have shown an overall~     cure rate of close to 100%. More than 50% of patients stated they would have FMT as their~     preferred first treatment option if CDI were to recur.~      This proposal aims to investigate the efficacy of FMT as first line therapy in patients with~     severe CDI and to assess changes in the fecal microbiota after FMT using pyrosequencing~     techniques.~   "
76147|NCT02570269|"~     The study has to show that an intubation with the AuraGain Laryngeal mask could bring the~     same benefits in terms of intubation in clinical practice, as the slotted Guedel tubus.~   "
76196|NCT02569632|"~     This study will investigate the breadth of protection against meningococcal disease in humans~     immunized with a newly FDA approved meningococcal B vaccine, trade name Trumenba®~     manufactured by Pfizer Vaccines. As a secondary goal the investigators will investigate~     underlying mechanisms by which human anti-FHbp antibodies elicit complement-mediated~     bactericidal activity.~   "
76132|NCT02570464|"~     Multiple organ dysfunction syndrome is a major cause of morbidity and mortality after~     abdominal aortic aneurysm (AAA) surgery. It is postulated that aortic cross-clamping during~     open AAA repair may cause ischemia-reperfusion (I/R) leading to the systemic releases of~     reactive oxygen species (ROS) and inflammatory cytokines which damage distant organs,~     including heart, kidney, and lung.~      Ischemic preconditioning, first described in cardiac surgery, is a mechanism whereby tissues~     exposed to a brief period of nonlethal I/R develop resistance to subsequent ischemic insult.~     Remote ischemic preconditioning (RIPC), is a phenomenon whereby brief periods of ischemia~     followed by reperfusion in one organ (usually skeletal muscle) provide systemic protection~     from prolonged ischemia. The mechanisms through which RIPC confer organ protection remains~     unclear.~      The hypothesis is that limb RIPC would reduce systemic inflammatory mediators produced by~     ischemia-reperfusion and thereby protect the remote organs.~      A single-center, prospective, randomized, parallel-group controlled trial is conducted on~     patients undergoing elective open infrarenal AAA repair. Written informed consent is obtained~     from each participant. The study protocol was reviewed and approved by the Research Ethics~     Committee of Rouen, France.~      Patients are divided in two groups : the sham-operated control group underwent surgery~     without RIPC and the RIPC group : Two cycles of intermittent crossclamping of the common~     iliac artery (right or left) with 10 minutes ischemia followed by 10 minutes reperfusion~     served as the RIPC stimulus, before prolonged ischemia.~      Blood samples are collected for analysis at the following time points: before surgery~     (baseline), 1, 3 and 24 h after cross-clamp release (reperfusion). The systemic inflammatory~     response is measured using the serum concentrations of TNF-alpha, and IL 1, 4, 6, 10.~     Cardiac, renal and pulmonary functions are evaluated with usual biological markers and~     clinical monitoring until 28 days after surgery.~      Aortic surgery is a perfect clinical model of ischemia-reperfusion which makes it possible to~     study the impact of RIPC in humans. This biological approach would help to better understand~     the mechanisms underlying this technique.~   "
76133|NCT02570451|"~     The overall objectives of this study are to improve outcomes of surgical patients 65 years of~     age or older through risk stratification based on preoperative screening of cognition /~     mental function. Aim 1 is to determine the prevalence of cognitive impairment among patients~     65 years of age or older presenting for elective joint replacement surgery by structured~     cognitive screening versus standard practice. Aim 2 is to ascertain whether preoperative~     cognitive impairment in patients 65 years of age or older undergoing elective joint~     replacement surgery is an independent predictor of adverse postoperative events and/or~     mortality. Aim 3 is to implement routine structured preoperative cognitive screening of~     patients 65 years of age or older undergoing elective surgical procedures in a busy~     preoperative clinic.~   "
76134|NCT02570438|"~     The hypothesis is that structured preoperative cognitive screening of seniors is feasible~     without specialized staff and can help preoperatively identify persons at high risk of~     complications. To demonstrate generalizability of the single center experience, and~     strengthen the case for routine preoperative cognitive screening of seniors, the aims of this~     proposal are to implement preoperative cognitive screening of seniors in the preoperative~     clinics of a community hospital (NWH) and a 2nd tertiary care institution (MGH); and~     determine whether impairment is an independent predictor of adverse perioperative events.~   "
76135|NCT02570425|"~     This study is conducted to assess the ease of device mastery of a placebo SYMBICORT~     TURBOHALER vs a placebo Budesonide/Formoterol SPIROMAX device among healthcare professionals~     in-training (HCP).~   "
76136|NCT02570412|"~     Compassionate use of aldoxorubicin in sarcoma patients who have failed prior chemotherapy.~   "
76137|NCT02570399|"~     This is a prospective, multicentric, phase II and feasibility study aimed to address early~     and late side effects of hypofractionated ablative radiotherapy for oligometastatic patients~     with lymph node metastases for genito-urinary, gastro-intestinal and gynaecological cancer.~   "
76138|NCT02570386|"~     The objective of the present randomized controlled study is to compare clinical effectiveness~     and safety of freezing all embryos followed by frozen-thawed embryo transfer (FET) compared~     to fresh embryo transfer, in women undergoing IVF treatment.~   "
76139|NCT02570373|"~     The purpose of this study is to characterize the elimination of guselkumab glycoform variants~     following a single intravenous (IV) administration of guselkumab at a 10 milligram per~     kilogram (mg/kg) dose in healthy participants.~   "
76140|NCT02570360|"~     The research study compares the substance abuse treatment outcomes (e.g., craving, withdrawal~     symptoms, rates of use, abstinence) of standard intensive outpatient care, with or without an~     added 6-wk aerobic exercise component. In addition, certain biomarkers associated with both~     exercise and substance use (e.g., endocannabinoids and cortisol) will be assessed. In a~     rolling admissions format over the course of a year, approximately 36 treatment-seeking~     substance users who are currently receiving Intensive Outpatient Treatment through a local~     Alcohol or Other Drug Abuse agency will be randomized to either receive 6 weeks aerobic~     exercise training in addition to standard care or standard care with 6 weekly laboratory~     visits to complete questionnaires (18 per group).~   "
76141|NCT02570347|"~     Clinicians tend to overuse antibiotics in snake bite despite evidence from three previous~     clinical trials that failed to show a benefit. But, none of these trials was done in India.~     Further, the species of snake in two of these trials was quite different from that seen in~     the Indian setting limiting generalization of these findings. Hence, home-grown evidence is~     needed to persuade clinicians to use antibiotics rationally.~   "
76142|NCT02570334|"~     This study aims to perform a comprehensive neuro-cognitive evaluation of the 4-7 year old~     children from the Pediacam cohort (ANRS 12140 /12225, NCT02043418). It is expected thereby to~     provide complementary information to the trials CHER and PREDICT on the long term development~     of (1) HIV-infected children according to age at ARV initiation and (2) HIV exposed but not~     infected children, all compared with the control group of children uninfected, unexposed to~     HIV.~   "
76143|NCT02570321|"~     The primary purpose of this study is to determine if patients randomized to corneal collagen~     cross-linking plus medical therapy will have a lower prevalence of positive bacterial or~     fungal cultures immediately after the procedure than patients who received medical therapy~     alone.~      The secondary purpose of this study is to determine if patients randomized to corneal~     collagen cross-linking will have a better visual acuity at 3 and 12 months than patients who~     receive medical therapy alone.~   "
76144|NCT02570308|"~     IMCgp100-102 is a Phase I study of the weekly intra-patient escalation dose regimen with~     IMCgp100 as a single agent in patients with metastatic uveal melanoma (mUM). According to~     this regimen, all patients in the trial will receive 2 weekly doses of IMCgp100 at a dose~     level below the identified weekly recommended Phase II dose (RP2D-QW) and then a dose~     escalation will commence at the third weekly dose at C1D15. The Phase I testing of the~     intra-patient escalation dosing regimen is designed to achieve a higher exposure and maximal~     plasma concentration of IMCgp100 after doses at Cycle 1 Day 15 (C1D15) and thereafter .~   "
76148|NCT02570256|"~     This study investigates the potential of customized robotic and visual feedback interaction~     to improve recovery of movements in stroke survivors. While therapists widely recognize that~     customization is critical to recovery, little is understood about how take advantage of~     statistical analysis tools to aid in the process of designing individualized training. Our~     approach first creates a model of a person's own unique movement deficits, and then creates a~     practice environment to correct these problems. Experiments will determine how the~     deficit-field approach can improve (1) reaching accuracy, (2) range of motion, and (3)~     activities of daily living. The findings will not only shed light on how to improve therapy~     for stroke survivors, it will test hypotheses about fundamental processes of practice and~     learning. This study will help us move closer to our long-term goal of clinically effective~     treatments using interactive devices.~   "
76149|NCT02570243|"~     This is a prospective, multi-center, superiority study of parallel design. Patients are~     enrolled if they are older than 18 years old, are scheduled for 5 or 6 Fr diagnostic coronary~     angiography and the interventional cardiologist is willing to proceed with radial access.~     Patients are randomized before diagnostic catheterization to receive intravenously either~     100IU/Kg or 50 IU/Kg of unfractionated heparin (UFH) in a 1:1 ratio. Patients are discharged~     usually within 4 to 6 hours after coronary angiography.~      Radial artery in each patient is evaluated either in-hospital or during a subsequent visit by~     one physician who is blinded to the actual antithrombotic treatment given. Radial artery is~     considered occluded if it exhibits ultrasonographically no antegrade flow signal both at~     baseline and after reevaluation on a second occasion, within 30 days after the index~     procedure. Initially patent arteries will not be reexamined and are thought to remain~     permanently patent. The investigators also monitor major bleeding (defined as ≥ 5g/dL~     decrease in hemoglobin or ≥15% decrease in hematocrit or any life-threatening bleeding~     (confirmed by MRI or computed tomography) and large local hematomas of the forearm (defined~     as those extending beyond the forearm).~   "
76150|NCT02570230|"~     Thoracotomy is one of the most painful operation. Continuous thoracic epidural or~     paravertebral analgesia are gold standard for postoperative pain. But both techniques require~     skills. Spinal morphine is alternative simple method with less efficacy. Adding low dose~     ketamine during intraoperative may be helpful in postoperative pain relief.~   "
76151|NCT02570217|"~     Preterm infants ranging from 29+0 to 36+6 weeks+days are randomly assigned to one of the~     following treatments as non invasive respiratory support if they develop mild to moderate~     Respiratory Distress Syndrome within 72 hrs from birth: 1) NCPAP set at 4-6 cmH2O or 2)~     HHHFNC providing a flow 4-6 l/min.~      The aim of the study is to assess efficacy and safety of relative new form of respiratory~     support (HHHFNC) versus a more common one (NCPAP).~   "
76152|NCT02570204|"~     This study aims to investigate the effectiveness and acceptability of the multi-level~     pregnancy test for self-assessment of abortion outcomes, without a routine provider contact.~   "
76153|NCT02570191|"~     This study will evaluate the efficacy, safety, and tolerability of PEGASYS in participants~     with HBeAg-negative chronic HBV. The anticipated time on study treatment is 48 weeks, and the~     target sample size is 60 individuals.~   "
76154|NCT02570178|"~     The objectives of this study are to evaluate the usefulness of an intervention utilizing the~     NintendoTM Wii console in order to improve balance, thereby decreasing both the fear of~     falling as well as the number of falls, and to evaluate the correlation between balance as~     determined by the console and the value obtained in the Tinetti tests and the one foot~     stationary test.~   "
76155|NCT02570165|"~     Batefenterol is a novel bifunctional molecule that combines muscarinic antagonism and~     beta2-agonism in a single molecule. This is a multicenter, randomized, placebo-controlled,~     double-blind, parallel group study primarily designed to assess the dose response, efficacy~     and safety of five dose regimens of batefenterol administered via the dry powder inhaler~     (DPI) once-daily in the morning for 42 days in subjects with COPD. The information obtained~     from this study will be used to select the minimal, optimally effective and safe dose of~     batefenterol and also to evaluate the pharmacokinetic profile and established pharmacodynamic~     (PD) responses of batefenterol. These data will support for future studies with batefenterol~     in COPD subjects.~      The study will consist of a pre-screening visit, screening visit; a run-in period (2 weeks),~     treatment period of 42 days and a follow-up visit 7 days post-treatment. The total duration~     of the study for each subject will be approximately 9 weeks. Approximately 460 subjects will~     be screened in order to randomize approximately 320 subjects, assuming that 280 subjects will~     complete the study. During treatment period, subjects will be randomized to one of the~     following treatments delivered via DPI once daily in the morning: Batefenterol 37.5 mcg, 75~     mcg, 150 mcg, 300 mcg and 600 mcg, umeclidinium/vilanterol (UMEC/VI) 62.5/25 mcg and placebo.~     All subjects will receive supplemental albuterol/salbutamol to be used on an as-needed basis~     (rescue medication) throughout the study.~   "
76156|NCT02570152|"~     The purpose of this study is to determine the incidence of dengue fever and to build capacity~     for dengue vaccine trials in dengue-endemic regions of South Asia.~   "
76157|NCT02570139|"~     The purpose of the study is to evaluate the safety and efficacy of the investigational~     product (3M™ Cavilon™ Advanced High Endurance Skin Protectant) for the treatment of~     incontinence associated dermatitis.~   "
76158|NCT02570126|"~     The purpose of this study is to evaluate the safety and immunogenicity of 2 formulations of~     GSK Biologicals' varicella vaccines given as a 2-dose course in the second year of life.~   "
76159|NCT02570113|"~     The Ablative Solutions, Inc. Peregrine System Infusion Catheter is a catheter-based device~     which is intended to be used to ablate the afferent and efferent sympathetic nerves serving~     the kidneys. The catheter is inserted via the femoral artery, steered into the renal artery,~     and then delivers, by infusion from its distal end, a neurolytic agent. This targets the~     nerve bundles, which are in the adventitia - a sheath surrounding the artery. The aim is to~     reduce blood pressure in cases of hypertension, including seriously elevated blood pressure~     which does not respond to drug treatment. This study will evaluate the safety and performance~     of the device.~   "
76193|NCT02569671|"~     The aim of this randomized, controlled, multi-center study is to assess the clinical and~     radiographic outcomes of using a Straumann® Bone Level Tapered implant for immediate~     implantation following extraction of a tooth in the pre-molar and anterior region of the~     maxilla and mandible (test) compared to the outcomes of placing this implant in healed sites~     (control).~   "
76160|NCT02570100|"~     From a cellular perspective, breast cancers appear to develop hierarchically from a small~     contingent of cancer stem cells (CSCs). The presence of CSCs in tumor tissue is associated~     with an increased risk of recurrence and metastasis, as well as a worse prognosis. Thus,~     these CSCs exhibit resistance to conventional anti-tumor treatments such as radiotherapy and~     chemotherapy. Moreover, these treatments would favor the emergence of these CSCs and the~     reprogramming of non-CSCs in CSCs. It has been demonstrated in neoadjuvant that the~     proportion of CSCs before any treatment is correlated with chemoresistance and that a~     resurgence of CSCs after chemotherapy is correlated with a poor prognosis. However, the~     mechanisms involved in the emergence of CSCs by reprogramming of non-CSCs are not yet known.~      The Oscar Lambret Center proposes a monocentric prospective interventional study based on the~     cellular and molecular analysis of the tumor, serum and circulating cells, before, during and~     at the end of the treatment for each patient receiving a neoadjuvant chemotherapy for breast~     cancer. The identification of the mechanisms contributing to the enrichment of CSCs resistant~     to chemotherapy could lead to therapeutic solutions.~   "
76161|NCT02570087|"~     The investigators studied the effect of CTO-PCI on left ventricular function and clinical~     parameters in patients with HFrEF.~   "
76162|NCT02570074|"~     Oral dosage regimens for fosfomycin tromethamine (Monurol™) are not established for the~     treatment of cUTI. The most common and recommended adult dosage regimen in the literature is~     a single-dose sachet containing the equivalent of 3 grams of fosfomycin administered every~     other day (QOD) for a total of three doses.~      There are a myriad of different oral fosfomycin dosing regimens currently being used in~     clinical practice, including up to 3 grams orally twice daily for 7-21 days, but these~     regimens are not based on solid pharmacokinetic, pharmacodynamic or safety rationale. Initial~     pharmacokinetic studies performed with oral fosfomycin tromethamine primarily examined single~     dose regimens and did not use modern day bioanalytical or pharmacokinetic techniques. As the~     use of fosfomycin becomes more pervasive in concordance with the increase in multidrug~     resistant pathogens, further pharmacokinetic and safety data are needed for more intensive~     dosing regimens to support its continued use.~      The rationale of this study is that oral fosfomycin tromethamine requires a modern~     pharmacokinetic-pharmacodynamic study to identify alternative oral dosage regimens that are~     appropriate and safe. This study will provide safety/tolerability and clinical pharmacology~     information regarding two oral dosing regimens that may have application to treat various~     types of infections involving resistant pathogens or when other oral antibacterial options~     are not available.~   "
76163|NCT02570061|"~     This study examined the use of the telephone for the purpose of informing expectant mothers~     about a randomized clinical trial assessing neonatal Bacille Calmette-Guérin vaccination.~     Expectant mothers who were contacted for participation in a vaccination trial (the Calmette~     study, NCT01694108) were randomized to receive information by telephone or at a face-to-face~     consultation. The primary outcome was a communication score, consisting of comprehension of~     information about the study and satisfaction with the information process. The outcome was~     measured using a questionnaire two weeks after the information was provided and two and a~     half months after birth.~   "
76164|NCT02570048|"~     This is a novel experimental device 'MuteButton' can affect the awareness of tinnitus. Sound~     that arrives at the ears naturally will be presented in the form of touch patterns on the~     tongue. By learning to associate the sounds in the ears with the sound patterns on the~     tongue, investigators aim to demonstrate that the brain will learn to discriminate the real~     sounds from legitimate external sounds from the imaginary tinnitus sounds that are created~     inside the brain. Tinnitus is an audiological condition most commonly described as 'ringing~     in the ears' that affects an estimated 40 million people globally (American Tinnitus~     Association; Royal National Institute for Deaf). More accurately, tinnitus is the perception~     of illusory sound that has no legitimate external source and normally arises from a small~     number of underlying neuropathologies. There are broadly two categories of tinnitus Somatic~     Tinnitus and Hearing Loss Related Tinnitus.~      MuteButton is indicated for the treatment of permanent intractable subjective tinnitus. The~     study is intended to show the efficacy of MuteButton treatment in alleviating tinnitus. The~     objective of the study will be to determine the impact of acoustic and tactile multi-modal~     neuromodulation on symptoms of permanent intractable tinnitus as measured by objective and~     subjective measures including Minimum Masking Level (MML), Tinnitus Loudness Masking~     (Tinnitus Loudness Masking), Tinnitus Handicap Inventory (THI) and Visual Analogue Scale~     (VAS).~   "
76165|NCT02570035|"~     This purpose of this study is to investigate the effects of mirabegron on the cardiovascular~     system in patients with overactive bladder with current or a history of cardiovascular~     disease.~   "
76166|NCT02570022|"~     This is a randomized, single blinded, standard of care controlled clinical trial. All adult~     patients over eighteen desiring shoulder arthroplasty will be eligible. The study compares~     pain control and opioid consumption in patients undergoing shoulder arthroplasty between~     patients receiving liposomal bupivacaine and those who underwent a preoperative inter-scalene~     nerve block.~   "
76167|NCT02570009|"~     Obesity risk is shared within married couples yet most existing weight loss programs focus on~     individuals and not the marital dyad. This project will test the effects of a couples weight~     loss program that teaches spouses how to provide each other with autonomy support and create~     an interpersonal environment that promotes sustained behavior change.~   "
76168|NCT02569996|"~     This study will evaluate the efficacy, safety, and tolerability of long-term maintenance~     therapy with rituximab in participants with advanced follicular lymphoma who have had a~     positive response to first-line treatment with a rituximab-containing regimen. The~     anticipated time on study treatment is 2 years, and the target sample size is 124~     individuals.~   "
76169|NCT02569983|"~     The primary aims of the SOCQER-2 study are to describe any impact on short (6 weeks), medium~     term (6, 12 months) and long term (18 months, 24 months) PRO/quality of life using validated~     questionnaires in patients undergoing standard or extensive surgery for suspected or~     confirmed Stage III/IV ovarian cancer and to describe progression free survival (PFS) in~     these patients.~   "
76194|NCT02569658|"~     To compare intravenous Tranexamic Acid (TXA) versus normal saline placebo to determine~     whether or not TXA administration reduces blood loss, decrease in hemoglobin, and rate of~     transfusions following anatomic and reverse total shoulder arthroplasty (TSA) surgeries.~   "
76170|NCT02569970|"~     Sudden unexpected death in epilepsy (SUDEP) is a tragic outcome of seizure disorders that~     primarily affect young adults suffering from refractory epilepsy. In this population, SUDEP~     incidence is estimated at 0.5%. While the mechanisms of SUDEP are not completely understood,~     it appears that the majority of such death occurs in the immediate aftermath of a general~     tonic-clonic seizure.~      There is currently no validated preventive treatment for SUDEP. Some evidence suggest that~     modulation of the serotoninergic tone, and more specifically selective serotonin recapture~     inhibitor (SSRI) such as fluoxetine, might prevent SUDEP. Indeed, fluoxetine prevents~     seizure-induced lethal central apneas in DBA/2 and DBA/1 mice, one of the few animal models~     of SUDEP. Furthermore, serotoninergic bulbar nuclei are known to play a major role in the~     control of breathing, especially during sleep and in response to repeated hypoxia.~      In patients with epilepsy undergoing in-hospital video-EEG monitoring, about one third of~     seizures are associated with decrease in SpO2 <90%, an abnormality suspected to represent a~     risk factor of SUDEP. In a retrospective uncontrolled study, patients treated with SSRIs~     displayed less frequent ictal/post-ictal hypoxemia than patients not taking SSRIs.~      The investigators project aimed at testing whether fluoxetine can reduce the risk of~     ictal/post-ictal hypoxemia by performing a double-blind, randomized, placebo-controlled trial~     in patients undergoing video-EEG monitoring as part of the pre-surgical evaluation of their~     focal drug-resistant epilepsy.~   "
76171|NCT02569957|"~     This randomized phase II trial studies the effects of acetylcysteine and topotecan~     hydrochloride on the tumor microenvironment, or cells that make up a tumor, compared to~     topotecan hydrochloride alone in patients with ovarian, fallopian tube, or primary peritoneal~     cancer that has not responded to treatment (persistent) or has returned after a period of~     improvement (recurrent) and is high grade (likely to grow and spread quickly). Research has~     shown that cancer cells may be able to convert nearby normal cells into cancer cells.~     Acetylcysteine may stop this from happening. Topotecan hydrochloride is a chemotherapy drug~     used to treat ovarian cancer, and may help acetylcysteine work better. This trial studies the~     effect of acetylcysteine and topotecan hydrochloride on the tumor microenvironment to see if~     they can help make it more difficult for tumor cells to grow.~   "
76172|NCT02569944|"~     Randomize trial by including patients up to 12 months old in whom a urine sample by a~     non-sterile method was requested under physician criteria. Intention-to-treat analysis was~     made.~      Urine dipstick was considered as altered if it was positive in leukoesterase test (≥2+) or~     nitrite test. In patients with an altered urine dipstick, a sterile sample was obtained for~     culture. If there was an initial altered urine dipstick with a subsequent negative urine~     culture it was considered as contaminated urine.~   "
76173|NCT02569931|"~     The principal objective of the study is to find out which everyday activities make the~     kneecap unstable in people with patellofemoral instability.~      Analysing how a patient with an unstable kneecap walks will help us to determine if surgery~     is successful in these patients by seeing if better scores on patient questionnaires are~     found in patients following surgery and whether these patients also have a better pattern of~     walking.~      The investigators aim to use cameras and pressure pads to see how patients walk before and~     after surgery and see how this compares to patient scores on the questionnaires.~      If the investigators find that patients walk better after surgery they can justify that~     surgery is worthwhile for the patient and cost effective for the NHS.~   "
76174|NCT02569918|"~     Phantom limb pain (PLP) is a frequent consequence of amputation, and it is notoriously~     difficult to treat. Amputation usually follows traumatic injuries or surgery following~     vascular diseases, diabetes, osteomyelitis or tumours in cases where the loss of the limb is~     required for the survival of the patient. The loss of a limb or other body parts is usually~     followed by the sensation that the lost body part is still present and can be felt. These~     phenomena are called, respectively, phantom awareness and phantom sensation. In 50-80% of~     amputees neuropathic pain develops in the lost limb also referred to as phantom limb pain~     (PLP). PLP can be related to a certain position or movement of the phantom limb, and might be~     elicited or worsened by a range of physical factors (e.g. changes in the weather or pressure~     on the residual limb) and psychological factors (e.g. emotional stress). It is well known~     that most treatments available for PLP today, such as pharmacological, surgical, anaesthetic,~     psychological and other, are ineffective.~      Today it is believed that phantom limb pain may be related to changes in the cortex of the~     brain. There is evidence that these changes may be modulated - or even reversed - by~     providing sensory input to the stump or amputation zone. For example, cortical reorganization~     and alleviation of phantom limb pain has been observed in amputees following intense use of a~     hand prosthesis. However, there is no consistent knowledge on which type of peripheral~     sensory feedback may be effective in affecting the cortical plasticity or on how to best~     apply the sensory feedback.~      The aim of the proposed research is to create natural, meaningful sensations through~     providing non-invasive sensory feedback (i.e. surface electrical stimulation) and the~     effectiveness to alleviate phantom limb pain and restore the cortical neuroplastic changes.~   "
76175|NCT02569905|"~     Shivering is an early postoperative complication during the postoperative recovery period,~     and there is no clear consensus about the best way for its prevention. The aim of the study~     was to compare the efficacy and accompanying side effects of prophylactic flurbiprofen with~     that of parecoxib or placebo for reducing postoperative shivering.~   "
76176|NCT02569892|"~     This is a randomized controlled study of non-damaging photothermal macular grid laser versus~     sham laser therapy in patients with dry age-related macular degeneration (AMD) and large~     high-risk drusen. The goal of the study is to determine if this treatment will reduce macular~     drusen volume and also whether this might improve visual acuity or reduce the risk of~     conversion to advanced age-related macular degeneration defined as development of choroidal~     neovascularization or geographic atrophy.~   "
76177|NCT02569879|"~     This study is being conducted to assess impact of maternal immunisation against pertussis in~     infants ≤12 months of age before and after introduction of pertussis maternal immunisation in~     Bogota, Colombia from January 2005-December 2014.~   "
76178|NCT02569866|"~     This study was designed to determine the role of antibiotics reduction mammaplasty influence~     surgical site infections rates.~   "
76179|NCT02569853|"~     Safety and Efficacy of DFN-11 in patients with episodic migraines with or without aura.~   "
76180|NCT02569840|"~     This study of the tolerance and acceptability of an amino acid based feed will assess~     gastrointestinal (GI) tolerance, product intake and acceptability in relation to taste,~     smell, texture in 20 patients between 1-10 years currently using or requiring an amino acid~     based feed for the dietary management of Cows' Milk Allergy and food-allergy-associated~     conditions, over 4 weeks.~   "
76195|NCT02569645|"~     This study will evaluate whether the addition of Rosuvastatin to standard chemoradiation~     therapy for the treatment of locally advanced rectal cancer may improve the pathological~     response rate and survival compared to standard chemoradiation therapy alone.~   "
76181|NCT02569827|"~     Dengue fever is an acute febrile illness transmitted by mosquitoes, which affects half the~     world's population. There are 96 million symptomatic infections, 500,0000 hospitalisations~     and 25,000 deaths per year attributed to the disease. The economic burden is $12 billion. In~     Singapore, as elsewhere, the incidence of the disease continues to increase despite~     aggressive control measures. At present there are no approved medicines for treating dengue~     fever. Only supportive fluid replacement therapy is used to treat vascular leakage in~     patients with severe illness. Therefore there is an urgent need to find alternative~     treatments. Experiments in the laboratory have shown that Celgosivir and modipafant inhibit~     dengue virus and improve mouse survival. Both drugs have previously been used in humans with~     good safety records, so investigators are taking this one step further to find out how well~     it works in dengue patients. Investigators plan to enroll dengue patients within 48 hours of~     fever onset and assign them to one of four treatment groups over five days. Together with the~     support from the industry partner, 60°Pharmaceuticals PLC, the investigators will determine~     the safety and effectiveness of these drugs on acute dengue patients and pave the way forward~     for dengue antiviral medicines to reach patients.~   "
76182|NCT02569814|"~     A Open-label, Randomized, Single-dose, 2x2 Crossover Study to Compare the Pharmacokinetics~     and Safety between a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin versus~     Co-administration of a Fixed Dose Combination of Fimasartan/Amlodipine and Rosuvastatin in~     Healthy Male Subjects.~   "
76183|NCT02569801|"~     The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of~     GDC-0810 compared with fulvestrant in postmenopausal women with advanced or metastatic~     estrogen receptor positive (ER+)/ human epidermal growth factor receptor 2 negative (HER2-)~     breast cancer resistant to AI therapy. The development of GDC-0810 has been halted by the~     Sponsor and the enrollment in this study has been discontinued. Participants currently~     enrolled in the study who are experiencing clinical benefit may continue receiving GDC-0810~     as a single agent or fulvestrant until disease progression (PD), unmanageable toxicity,~     withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of the study by the~     Sponsor.~   "
76184|NCT02569788|"~     The purpose of this study is to determine the maximal tolerated dose (MTD) of re-irradiation~     using carbon ion radiotherapy (CIRT) in the treatment of locally recurrent nasopharyngeal~     cancer (NPC) and to evaluate the efficacy of such treatment at the MTD. Participants will be~     treated with CIRT with escalating dose regimens to evaluate the maximal tolerated dose (MTD)~     in terms of acute and subactue toxicity observed during and within 4 months after the~     completion of CIRT. Once the MTD for locally recurrent NPC is determined, the MTD will be~     used as the recommended dose to patients fulfilling the inclusion criteria in the Phase II~     part of the trial.~   "
76185|NCT02569775|"~     The aim of this study is to assess the safety and effectiveness of autologous bone marrow~     mononuclear stem cells in patients with cerebral palsy.~   "
76186|NCT02569762|"~     The Objectives of this study is to determine the effect(s) of daily non-caloric artificial~     sweetener (NAS) consumption (sucralose or aspartame) on the composition of the bacteria and~     also to determine the changes in glucose metabolism.~   "
76187|NCT02569749|"~     To assess the incidence of Sleep Apnea-Hypopnea Syndrome (SAHS), both obstructive and~     central, in patients with: 1) pacemaker indication; 2) implantable cardioverter defibrillator~     (ICD) or cardiac resynchronization therapy (CRTD), 3) heart failure and preserved left~     ventricular ejection fraction (LVEF) and 4) heart failure and reduced LVEF.~   "
76188|NCT02569736|"~     Naïve CD4+ helper T (Th) cells, upon encountering their cognate antigens presented on~     professional antigen-presenting cells, differentiate into different effector cells:~        -  Th1 cells produce Interferon-γ and regulate antigen presentation and immunity against~          intracellular pathogens;~        -  Th2 cells produce IL-4 (Interleukin-4), IL-5 and IL-13, and mediate humoral responses~          and immunity against parasites;~        -  Th17 cells produce IL-17, IL-17F and IL-22 and regulate inflammatory responses by tissue~          cells.~      An additional TH subset called follicular helper T (Tfh) cells has recently been identified~     in germinal centers and also in whole blood (circulating Tfh cells). These cells regulate~     B-cell maturation and immunoglobulin production during normal immune responses. They produce~     factors essential for B cell selection and maturation into memory B-cells or long-lived~     antibody-secreting plasma cells. Furthermore, they also seem to favor pathogenic autoantibody~     production in systemic autoimmunity, and therefore could potentially represent a novel~     therapeutic target in autoimmune diseases. Indeed, rheumatoid arthritis synovium is~     characterized by the presence of ectopic lymphoid structures, resembling germinal centers.~     Potentially, Tfh cells from these nonlymphoid tissues could promote B-cell maturation and~     synthesis of pathogenic autoantibody production, thus potentiating tissue injury.~     Interestingly, production of IL-21 by Tfh cells is implicated in B cell activation, and the~     same cytokine have been associated with rheumatoid arthritis (RA) pathogenesis.~      IL-6 blocking therapy significantly reduces signs and symptoms as well as radiological~     progression in RA. However, so far, it has not been determined which of the pleiotropic IL-6~     effects impact the observed clinical response. Recently, Samson et al have demonstrated that~     Tocilizumab (TCZ) corrects the imbalance between Th17 cells and Treg cells in patients with~     RA. More interestingly, the group of Hans-Peter Tony has reported the impact of TCZ on B cell~     compartment. They showed a significant reduction in the frequency of peripheral pre-switch~     and post-switch memory B cells but also a reduction of serum immunoglobulin levels, that~     could be the reflect of TCZ on Tfh cells development, circulation and/or function.~      Most of the work studying the role of IL-6 on Tfh cells development has been performed in~     mice. They showed that optimal Tfh cells formation requires IL-21 and IL-6, and that~     cytokines alone are insufficient to drive Tfh cells differentiation.~      To better understand the impact of IL-6 on human Tfh cells, the investigators would like to~     conduct a prospective study in patients with active RA and investigated the effects of~     blocking IL-6 with TCZ on circulating Tfh cells levels and Tfh cells subsets over a 12-week~     study period. Furthermore, the impact of TCZ treatment on Tfh cells generation will be~     explored in vitro.~   "
76189|NCT02569723|"~     This pilot clinical trial studies how well carbon C 14 oxaliplatin microdosing assay works in~     predicting exposure and sensitivity to oxaliplatin-based chemotherapy in patients with~     colorectal cancer that has spread to other places in the body and usually cannot be cured or~     controlled with treatment. Drugs used in chemotherapy, such as oxaliplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Carbon C 14 is a radioactive form of carbon,~     exists in nature and in the body at a low level. Microdose carbon C 14 oxaliplatin diagnostic~     assay may help doctors understand how well patients respond to treatment and develop~     individualize oxaliplatin dosing in patients with colorectal cancer.~   "
76190|NCT02569710|"~     This randomized, open-label study will assess the safety, pharmacokinetics and efficacy of~     the orally administered combination of AL-335, ACH-3102, and simeprevir in treatment-naïve~     subjects with chronic hepatitis C (CHC) infection.~   "
76191|NCT02569697|"~     The purpose of this study is to develop markers for use of placebo vaginal products and~     measure markers of mucosal semen exposure among healthy women. The study will also monitor~     safety of placebo product use.~   "
76192|NCT02569684|"~     The aim of the study is to compare the effects of prebiotics versus placebo on blood~     concentrations of glucagon-like peptide-1 in subjects with diabetes type 2.~   "
76198|NCT02569606|"~     Comparison of the consumption of blood and coagulation products (packed red blood cells,~     fresh frozen plasma, platelet concentrates, fibrinogen, coagulation factor concentrates,~     coagulation factor XIII, activated factor VII, van Willebrand factor and antifibrinolytics)~     before and after the introduction of a designated trauma related transfusion and coagulation~     algorithm.The periods 2005-2007 (before) and 2012-2014 (after) the introduction are reviewed.~     Two level-1 trauma centers in Switzerland (Hospital Lucerne, University Hospital Zurich) are~     included in the study. Predicted probability of a massive transfusion by the trauma~     associated acute hemorrhage score (TASH)is correlated with the actual rate.~   "
76199|NCT02569593|"~     Obese volunteers who have scheduled a gastric bypass (RYGB) in UZ Leuven will be asked to~     participate in a cross-over study using commercial available iron supplements. The aim of~     this study is to evaluate the absorption rate of different oral iron supplements in~     volunteers before and after RYGB (1, 3, 6 and 12 months post-RYGB).~   "
76200|NCT02569580|"~     The purpose of this study is to determine effectiveness of an Anti-lice treatment using the~     medical device No More which is designed to kill lice and lice eggs on the head.~   "
76201|NCT02569567|"~     The aim of this prospective study was to evaluate the applicability and diagnostic~     performances of Smart-Shear wave(SSW) imaging, in comparison with Transient elastography(TE)~     for the staging of liver fibrosis using pathologic results as the reference standard.~   "
76202|NCT02569554|"~     The current study will be conducted in healthy adult subjects to evaluate the effect of~     proton pump inhibitor and food on pharmacokinetics of PF-06463922, to evaluate the~     bioavailability of the oral solution relative to the tablet formulation of PF-06463922.~   "
76203|NCT02569541|"~     To evaluate the safety and effectiveness of oral sodium fusidate (CEM-102) as chronic~     antibiotic for the treatment of bone or joint infections.~   "
76204|NCT02569528|"~     The goal of this study is to learn about the patient and provider perceptions, priorities,~     preferences, and willingness to use/prescribe anticoagulation as a stroke prevention therapy~     in patients with atrial fibrillation. Qualitative interviews will be performed with atrial~     fibrillation patients and providers caring for atrial fibrillation patients. The~     investigators want to understand the factors that influence decision-making about~     anticoagulation medications, and to gain insight into patients' and providers' knowledge of~     the risk of stroke and bleeding associated with oral anticoagulation. This feedback will help~     provide better education to providers caring for patients with atrial fibrillation and better~     care to patients with atrial fibrillation by developing tools to optimize the appropriate use~     of oral anticoagulation for patients with atrial fibrillation.~   "
76205|NCT02569515|"~     This study will evaluate the tolerability, and effect on quality of life, in patients~     receiving multi-dose NeoRecormon administered by RecoPen in predialysis patients with chronic~     renal anemia. The anticipated time on study treatment is 10 months, and the target sample~     size is 60 individuals.~   "
76206|NCT02569502|"~     This study will evaluate the safety and tolerability of subcutaneous Fuzeon in patients with~     advanced HIV-1 infection unable to construct an appropriate treatment regimen from currently~     available antiretroviral agents. The anticipated time on study treatment is 3-12 months, and~     the target sample size is 9 individuals.~   "
76207|NCT02569489|"~     This is a phase I multi-center dose escalation study of the histone deacetylase inhibitor~     (HDACi) HBI-8000 when given in combination with paclitaxel and trastuzumab in women with~     advanced or metastatic HER2+ breast cancer.~   "
76208|NCT02569476|"~     This study is evaluating the safety and preliminary efficacy of BGB-3111 in combination with~     obinutuzumab in subjects with B-cell lymphoid malignancies.~   "
76209|NCT02569463|"~     The investigators evaluate the effectiveness and safeness of low-dose Recombinant Human~     Interleukin-2 （rhIL-2） for MAS.~   "
76210|NCT02569450|"~     This two arms parallel cluster-randomized trial will evaluate the impact of monitoring~     surgical outcomes using Shewhart control chart (intervention) on the occurence of major~     adverse events, among a large sample of French surgical departments. Trends in surgical~     outcomes before and after the intervention will be compared between arms.~   "
76211|NCT02569437|"~     The Department of Otolaryngology at Mount Sinai is looking for adults with sinus disease with~     polyps, otherwise called chronic rhinosinusitis with nasal polyps (CRSwNP). Patients may be~     eligible to enroll in a study offering a cutting-edge therapy to help reduce symptoms and~     avoid surgery. The treatment combines an antibiotic (doxycycline) with oral steroids. Oral~     steroids are the mainstay of medical management for patients with CRSwNP. However, recent~     studies have shown that doxycycline helps improve symptoms as well by reducing inflammation~     and killing common bacteria that can cause symptoms. This study is the first to evaluate this~     combination regimen.~   "
76212|NCT02569424|"~     There is no recommendation for the management of the positive end-expiratory pressure (PEEP)~     during setting of a central venous catheter (CVC) in a ventilated patient. Several~     non-randomized studies have investigated the cross-sectional area (AST) ultrasound minor axis~     for different pressure levels by evaluating a single vessel every time or by not displaying~     the right or left side in the evaluation. Another study showed that there could be~     unpredictable size differences between the 2 subclavian veins.~      In ventilated patient, the PEEP, which is intrathoracic, will result in a decrease of venous~     return and thus possibly a superior vena cava dilation, located outside the pleura, depending~     on their capacitance. Different pressure levels showed an increase of AST with the increase~     of intra-thoracic pressure on certain veins, in a heterogeneous and not randomized manner.~      The primary purpose of the study is to measure the effect of PEEP (0, 5, 10 or 15 cm H2O) and~     the patient's position (supine or Trendelenburg strict -15-20 °) on the cross-sectional area~     of the jugular and subclavian veins.~   "
76213|NCT02569411|"~     The objective of this study is to examine the impact of incentivizing authors of RCTs that~     are eligible for a systematic review and meta-analysis, versus usual contact strategies to~     obtain original IPD~   "
76214|NCT02569398|"~     The purpose of this study is to evaluate whether treatment with JNJ-54861911 slows cognitive~     decline compared with placebo treatment, as measured by a composite cognitive measure, the~     Preclinical Alzheimer Cognitive Composite (PACC), in amyloid-positive participants who are~     asymptomatic at risk for developing Alzheimer's dementia.~   "
76217|NCT02569359|"~     Recurrent hemarthrosis results in synovitis and destructive arthropathy in hemophilic~     patients. Prophylactic replacement, physical therapy, cyclooxygenase-2 (COX-2) inhibitors,~     corticosteroids, and radionucleotide synovectomy are some of the typical modalities used in~     the managements hemophilic synovitis and arthropathy. In clinical practice, the choice of~     non-steroidal anti-inflammatory drugs (NSAIDs) also needs to take into consideration the risk~     for cardiovascular events and should be used at the lowest effective dose and for the~     shortest duration.This study will investigate the safety and efficacy of Shea nut oil for the~     treatment of hemophilic arthropathy.~   "
76218|NCT02569346|"~     Dolutegravir is an HIV-1 integrase inhibitor which is marketed as a single tablet (Tivicay®)~     and in a fixed dose combination tablet with abacavir and lamivudine (Triumeq®, referred to as~     TRI). For patients with swallowing difficulties, administration of whole tablets can be~     problematic and tablets are cut or crushed to ease administration.~      Currently there is no information about crushing TRI tablets. Therefore this study will be~     conducted to investigate whether crushed and suspended TRI and crushed and suspended TRI with~     drip feed are bioequivalent to taking TRI as a whole.~   "
76219|NCT02569333|"~     Hospitalized patients with ulcerative colitis (UC) are at increased risk for a variety of~     complications such as infections, venous thrombosis, and surgery. The literature has revealed~     significant variation in the quality of care to hospitalized UC patients. As a result,~     guidelines for the management of these patients have been developed. However, the update of~     guidelines are variable. Admission to hospital can also have significant impact on quality of~     life due to interruptions in life commitments and lost sense of control of disease.~     Maintaining a sense of self-control of disease and active participation in care has been~     shown to be valuable among individuals with chronic diseases. The investigators propose the~     development of a multi-site, patient centred initiative aimed at improving clinical and~     patient-centered outcomes through an educational iPad based tool for patients admitted to~     hospital with ulcerative colitis.~   "
76220|NCT02569320|"~     This pilot phase I trial studies the side effects and best dose of histone deacetylase (HDAC)~     inhibitor AR-42 (AR-42) when given together with pomalidomide in treating patients with~     multiple myeloma that has returned after a period of improvement. HDAC inhibitor AR-42 may~     work to stop cancer growth by blocking an enzyme needed for cell growth. Pomalidomide is a~     drug used in chemotherapy that works to stop the growth of cancer cells by causing them to~     die. Giving HDAC inhibitor AR-42 together with pomalidomide may cause patients to respond~     better to treatment.~   "
76221|NCT02569307|"~     This is a randomized double-blind placebo controlled trial which aims to evaluate the~     efficacy and tolerability of minocycline and Omega-3 fatty acids for patients with ARMS.~     Specifically to determine whether the addition of minocycline and / or Omega-3 fatty acids to~     Treatment as Usual in an operationalized ARMS population in Pakistan:~   "
76222|NCT02569294|"~     This is a clinical non-randomized prospective study. This study had two objectives. The fist~     one was to determine the interest of breast cancer patients in participating in one of three~     group interventions (CBT, yoga or self-hypnosis) by assessing the participation rate, the~     reasons for choosing a particular group or decline the offer. The second objective was to~     evaluate and compare the benefits of these three interventions on emotional distress, QoL,~     sleep quality and mental adjustment to cancer, at three times after the end of the~     interventions (just after the end, at a 3-month and at a 9-month follow-up).~   "
76223|NCT02569281|"~     Scientific evidence of conservative management of subacromial pain syndrome is conflicting.~     There is evidence that eccentric exercise programs are effective at medium term for this pain~     condition. The inclusion of other therapeutic modalities is still controversial. A recent~     study suggests that the inclusion of US-guided percutaneous electrolysis combined with~     eccentric exercises can be effective at short-term for this condition. The objective of this~     randomized clinical trial is to determine the effectiveness at short- and long-term of the~     inclusion of US-guided percutaneous electrolysis (EPE®) into a eccentric exercise protocol~     for the management of patients with subacromial pain syndrome for pain, function, disability~     and pressure pain sensitivity.~   "
76224|NCT02569268|"~     Arteriosclerotic vascular-related diseases have become a serious threat to human health. The~     prevention and reversal of vascular events has become an important direction of medicine.~     Early vascular disease detection system includes pulse wave velocity (PWV), carotid~     intima-media thickness (IMT) and coronary flow velocity reserve (CFVR), flow-mediated~     vasodilation (FMD), cardio-ankle vascular index (CAVI), ankle-brachial index (ABI), insulin~     resistance index (HOMA-IR), hypersensitivity C- reactive protein (hs-CRP), plasma~     homocysteine (Hcy), B-type natriuretic peptide (BNP), uric acid (UA), and so on. However,~     there is no international and domestic comprehensive study on simple and practical evaluation~     system by jointing application of these evaluation indexes to detect vascular disease.~     Combined evaluation function can simultaneously detect and evaluate vascular abnormalities,~     make up a single indicator shortcoming in clinical applications from multiple levels of~     vascular structure and function. However, all indicators testing not only cause time~     consuming, but also increase the burden on patients, resulting unnecessary waste of medical~     resources. Thus, the present study was to select appropriate indicators and effective joint,~     and establish the rating system, using the vascular system to predict the incidence of~     terminal events, and compare this system with the previous scoring system such as FRS~     (Framingham Risk Score) pros and cons.~   "
76225|NCT02569255|"~     Use of new oral anticoagulants (NOAC) in patients before and after catheter based pulmonary~     vein isolation (PVI) is still controversial. Experience is reported from consecutive patients~     ablated with PVI for atrial fibrillation and treated with dabigatran, rivaroxaban, or~     apixaban from Nov 2011 until Dec 2014. Patients are followed for 3 month after ablation. All~     complications possible being related to the use of NOAC are registered.~   "
76226|NCT02569242|"~     The purpose of study is to evaluate the efficacy and safety of Nivolumab in unresectable~     advanced or recurrent esophageal cancer patients who have failed in standard chemotherapies.~   "
76227|NCT02569229|"~     The aim is to describe the association of glucose tolerance measured with three different~     tools (continuous glucose measurement system - CGMS, oral glucose tolerance testing - OGTT~     and optional intravenous glucose tolerance testing -IVGTT) with parameters out of lung~     function and anthropometric parameters in patients with cystic fibrosis.~   "
76229|NCT02569203|"~     To determine whether high-protein (24% of total calorie from protein) enteral nutrition of~     immune modulating nutrients (eg, ω-3 fatty acids and antioxidants) enriched with β-glucan~     stimulates immune functions compared with standard enteral nutrition (control: 20% of total~     calorie from protein) or high-protein (24% of total calorie from protein) enteral nutrition~     of immune modulating nutrients without β-glucan in critically ill patients.~   "
76230|NCT02569190|"~     Purpose: To evaluate the effect of robotic gait therapy for brain reorganization in~     hemiplegia patients.~   "
76231|NCT02569177|"~     Myocardial infarction and subsequent myocardial injury after cardiac surgery occurs in 7-15%~     of patients undergoing cardiac surgery and is associated with an increased length of stay,~     and reduced short- and long-term survival. Cardiac troponin is considered to be a cornerstone~     in the diagnosis of a myocardial infarction. Heart-type Fatty Acid-Binding Protein (H-FABP)~     is a new sensitive biomarker for myocardial injury. The effectiveness of using the~     combination of H-FABP with Troponin to diagnose myocardial injury within 6 hours after the~     onset of ischemia is well reported. Previous studies in non-surgical patients have associated~     increased H-FABP with an increased risk of subsequent death and major cardiac events. The~     prognostic value in cardiac surgery patients has not been studied extensively.~      The objective is to estimate the association between biomarkers of myocardial injury and~     myocardial infarction in patients undergoing cardiac surgery. Myocardial infarction will be~     established with both a new and very early marker of myocardial injury (Heart-type Fatty Acid~     Binding Proteins) as well as to a known early marker of such injury (Cardiac troponin).~   "
76232|NCT02569164|"~     PCO patients will be assessed clinically,urine & blood samples will be tested. Systolic &~     diastolic blood pressure, serum glucose & insulin levels, lipid profile, C-reactive protein,~     complete hormonal profile, and Urinary albumin excretion will be measured.~   "
76233|NCT02569151|"~     Participants were examined using the methods reported previous. All chemical laboratory data~     were obtained at each clinic visit in the morning in a non-fasting state. A single specimen~     at each visit was used to assess urinary albumin levels based on the 2009 guidelines of the~     ADA. CBP was measured once in each clinic visit. HBP was measured every day in the morning~     within 10 minutes after awakening in the sitting position, but HBP value assessed for this~     study used the value measured once in the same morning at each clinic visit.~      Clinic hypertension (CH) and morning hypertension (MH) were defined as systolic BP (SBP) 130~     mmHg and/or diastolic BP (DBP) 85 mmHg; clinic normotension (CN) and morning normotension~     (MN) were defined as SBP <130 mmHg and DBP <85 mmHg, respectively. The reason underlying that~     same threshold was used for both clinic and morning values was based on criteria of the 1999~     WHO-International Society of Hypertension guidelines, because this study started in 1999.~     Based on HBP, subjects were divided into MH and MN patients, and anti-hypertensive drug use~     was determined in each group. In addition, based on CBP, subjects were divided into CH and CN~     patients. These patients were followed using the same methods used for MH and MN patients.~      Outcome considered only the first event in each subject. Primary end-point was death from any~     cause. Secondary end-points were new, worsened, or improved microvascular and macrovascular~     events.~      Risk factors related to each outcome were determined, and therapy which was added to baseline~     used for each disease in patients with MH was recorded at base- and end-points.~      All results are presented as means ± SD. Mean values were compared using the paired or~     unpaired student t test. To compare the prevalence of events or medical treatment in patients~     with and without HT on basis of HBP or CBP, Fisher's exact test with two-tailed P values was~     used, and then hazard ratio and 95% confidence intervals were calculated.~      Differences in outcomes between patients with HT and NT on basis of HBP or CBP at base- and~     end-points in the home or in the clinic, respectively, were assessed using Kaplan-Meier~     survival curves and then compared by hazard rate using the log-rank test.~      Risk factors determined to be statistically related to outcomes were assessed by Cox~     proportional hazard analysis.~   "
76234|NCT02569138|"~     The purpose of this study is to investigate the long term balance-enhancing effects of~     insoles that are hard and thin for older adults. Thirty older female adults between the ages~     of 65-84 years will be recruited for this study. Twenty participants (20) will wear the~     experimental insole and ten (10) participants will work their usual insole, during a 12 week~     period. Balance and foot sensitivity testing will take place at 0, 6 and 12 weeks. These~     tests will involve measurement of body motion and foot pressure in order to evaluate balance~     control. Additionally, each participant will be asked to return a bi-weekly postcard that~     will report on footwear wearing patterns and any falls (or fall-related) incidents that have~     occurred during the 12 weeks.~   "
76235|NCT02569125|"~     This is an open-label, multicenter, single-arm, phase II clinical trial of Everolimus~     (RAD001) in patients with segmental overgrowth syndrome.~   "
76236|NCT02569112|"~     The purpose of this study is to evaluate the effect on the subject outcome using the~     combination of the Zeltiq Cryolipolysis device and the Venus Concept multipolar~     radiofrequency device with varipulse technology for the enhanced non-surgical treatment of~     skin laxity in the flank area.~   "
76237|NCT02569099|"~     The burden of stroke has continued to increase in Zimbabwe in the last 3 decades. resulting~     in increased burden of care to family caregivers. Caregivers who had cared for survivors for~     periods exceeding 3 months indicated desire to be taught about basic care before they were~     discharged from hospital and a curriculum of training based on a targeted needs analysis was~     developed. One arm of the study will receive caregivers training as the intervention and the~     other arm will be the control. The outcome of both the caregivers and survivors will be~     compared based on selected tools. Data will be collected at baseline (at most 2 weeks after~     suffering a stroke) the participants will be followed up at 3 and 12 months post stroke.~   "
76238|NCT02569086|"~     Antibiotic dosing in septic patients poses a challenge for clinicians due to the~     pharmacokinetic changes seen in this population. Piperacillin/tazobactam is often used for~     empirical treatment, and initial appropriate dosing is crucial for reducing mortality.~      The investigators aim was to determined the pharmacokinetic profile of piperacillin 4g every~     8 hour in 22 patients treated empirically for sepsis and severe sepsis. A PK population model~     was be established with the dual purpose to assess current standard treatment and to simulate~     alternative dosing regimens and modes of administration. Time above the minimal inhibitory~     concentration (T>MIC) predicted for each patient was evaluated against clinical breakpoint~     MIC for Pseudomonas Aeruginosa (16 mg/L). Pharmacokinetic-pharmacodynamic (PK-PD) targets~     evaluated were 100% f T>MIC and 50% fT>MIC.~   "
76239|NCT02569073|"~     In a recent study, Dronabinol was shown to reduce symptoms in patients with Functional Chest~     Pain (non-cardiac chest pain). Additionally, metabolic measures and patients' weights were~     not adversely affected by this regiment. In fact, some cholesterol measures trended in a~     favorable direction with Dronabinol. The study lasted 28 days and patients took Dronabinol~     twice daily. The goal of this current study focuses on reducing the dose of Dronabinol to see~     if the same goals can be achieved. More so, the study will be extended to 12 weeks to gain a~     more longitudinal picture of therapy with Dronabinol. It is hypothesized that reducing the~     dose and extending the duration will continue to show an improvement in symptoms as well as~     no adverse metabolic outcomes.~   "
76241|NCT02569047|"~     The aim of this, two-arm, parallel group, patient-randomised controlled, superiority trial is~     to evaluate the survival rate of approximal Atraumatic Restorative Treatment (ART)~     restorations compared to the Hall Technique (HT) placed in a school setting. The~     investigators will recruit 120 schoolchildren (6-8 years) with at least one occlusal-proximal~     carious lesion in primary molar. They will be randomized and treated following best-practice~     protocols to either receive an ART restoration using the high-viscosity glass ionomer cement~     (EQUIA Forte, capsules, GC Corp.) or a preformed metal crown placed using the HT (3M ESPE)~     cemented with glass ionomer luting cement (Fuji I Capsules, GC Corp.). Baseline measures and~     outcome data (at reviews over a three year period) will be assessed through participant~     report, clinical examination and parent report/ questionnaires.~   "
76242|NCT02569034|"~     Anhedonia, decreased motivation for and sensitivity to rewarding experiences, is present in~     at least 1/3 of community dwelling older adults and is a feature of various psychiatric and~     neurological disorders, including late-life depression and Parkinson's disease. Anhedonia is~     associated with cognitive deficits, as well as poor clinical outcomes and increased~     mortality. Recent research suggests that anhedonia comprises motivational (reward wanting)~     and consummatory (reward liking) aspects. However, previous research on anhedonia has~     failed to dissociate these components, which may explain the contradictory findings in the~     literature. Recently, the Effort-Expenditure for Rewards Task (EEfRT) was developed in an~     effort to dissociate reward components in anhedonia. The EEfRT is an effort-based~     decision-making task that measures reward wanting, in contrast to commonly used anhedonia~     questionnaires, which focus on reward liking. This novel task may provide a useful measure~     of components of anhedonia in older adults and in different patient populations. Thus far no~     data is available on this task in elderly individuals, and the cognitive and neural~     correlates of components of the task have not been investigated. Given the paucity of~     research on the neurobiology of anhedonia, cognitive neuroscience studies using this task~     could fill a gap in the literature. The investigators are developing a line of cognitive~     neuroscience studies examining anhedonia in community-dwelling older adults and in late-life~     depression and Parkinson's disease. This study will involve gathering pilot behavioral and~     functional magnetic resonance imaging (fMRI) data in young and older adults performing the~     EEfRT task. Understanding the brain mechanisms underlying anhedonia in older adults and in~     different patient populations will have a translational impact by elucidating biological~     targets for treatment.~   "
76243|NCT02569021|"~     The purpose of this research study is to test effectiveness of different deep brain~     stimulation (DBS) stimulation patterns on symptoms that may also improve the life of the~     battery. If these patterns are effective, the implanted batteries will be drained more slowly~     and last longer than currently expected. An increase in battery life may reduce the number of~     surgeries needed to replace them.~   "
76244|NCT02569008|"~     This study evaluate the effect of different doses of crystalloids on the changes on cardiac~     output (CO) and on the proportion of responders and non-responders and aims to determine the~     minimal volume required to increase the mean systemic filling pressures (Pmsf) in~     post-cardiac surgical patients.~   "
76245|NCT02568995|"~     Total hip arthroplasty (THA) is a common and standardized procedure. Postoperative mortality~     after hip joint replacement is low but some complications remain, including chronic~     post-surgical pain (1), hip dislocation (2), infection (3), and deep vein thrombosis (4).~     Strategies that have been identified to reduce morbidity and mortality include: posterior~     surgical approach, mechanical and pharmacological prophylaxis of deep vein thrombosis, and~     the use of spinal anesthesia (5). One of the important factors for patient satisfaction with~     lower limb arthroplasty is good postoperative pain management (6). Poorly managed~     postoperative pain can lead to chronic post-surgical pain and therefore aggressive~     postoperative pain management is important (7). Several different methods have been used to~     treat postoperative pain following THA. Recently, local infiltration analgesia (LIA) using a~     combination of large volume local anesthetics (LA) and non-steroidal anti-inflammatory agents~     (NSAID) injected systematically peri-articularly has been used for pain management with~     variable success (8). We found that better analgesia could be achieved when using LIA~     compared to intrathecal morphine during the first few days postoperatively (9,10).~      Ultrasound techniques are commonly used for peripheral nerve blocks and have been shown to~     reduce pain intensity and may be considered by many to be a standard of care. Specifically,~     the 3-in-1 block has been commonly used because of its ease of application and good pain~     management following total hip arthroplasty. The present study aims to compare postoperative~     pain intensity following local infiltration analgesia with a standardised 3-in-1 block for~     total hip arthroplasty.~   "
76246|NCT02568982|"~     This study aims at investigating the complications of Cushing's disease in de novo~     patients. A series of investigations will assay before treatment and every year thereafter~     during a 3 years follow-up period the various complications of the disease. These~     investigations will determine the presence and severity of cardiovascular, metabolic, and~     bone complications as well as the Quality of Life. Outcome of these complications after~     treatment, especially after pituitary surgery will be monitored, as well as cortisol levels.~   "
76247|NCT02568969|"~     The major combined interventions are between challenging and high-risk aspects of current~     cardiosurgical practice. The results of operation may be hampered by unexpected anatomic and~     technical features influencing the surgical approach as well as cardiopulmonary bypass (CPB),~     anesthesia, and respiratory support.~      Plasma lactate concentration is a routine clinical indicator of the tissue oxygen shortage,~     and is routinely monitored in virtually all in-risk surgical and ICU patients. However, the~     discrete measurement of these values among with other biochemical values has a major drawback~     and continuous measurement can be beneficial.~      The aim of our study is to assess the clinical usefulness and rationale for routine use of~     continuous monitoring of lactate in high-risk combined/complex cardiac surgery.~   "
76248|NCT02568943|"~     The purpose of this study is to provide oral panobinostat (PAN) treatment to relapsed or~     relapsed and refractory multiple myeloma patients who are without satisfactory treatment~     alternatives prior to the commercial availability* and reimbursement of panobinostat during~     the regulatory approval process. This protocol will acquire additional safety data on the use~     of panobinostat in combination with bortezomib (BTZ) and dexamethasone (Dex) in patients with~     relapsed or relapsed and refractory multiple myeloma. In this protocol, PAN must be~     administered in the defined regimen in combination with both BTZ and DEX.~      *(Note: throughout this protocol commercially available means local health authority~     approval and a functional method for reimbursement)~   "
76249|NCT02568930|"~     The purpose of this study is to compare health-related quality of life (HRQOL) outcomes in~     older (60-80 years) advanced heart failure (HF) patients who undergo heart transplantation~     (HT) or mechanical circulatory support (MCS) as a permanent implant (i.e., destination~     therapy [DT]) and their caregivers. Our study will contribute to better patient-centered care~     of older advanced HF patients and their caregivers, by informing decision making and guiding~     strategies to enhance post-operative HRQOL.~   "
76250|NCT02568917|"~     Background: Dental caries is still a public health problem among Brazilian children and~     doubts still exist regarding the most effective restorative technique. The aim of this~     pragmatic randomized clinical trial is to evaluate the effectiveness of single and~     multiple-surfaces restorations performed following the Atraumatic Restorative Treatment (ART)~     premises compared with Conventional Treatment (CT) in primary and permanent teeth.~      Methods: A total of 1,214 5-to-13 years-old children with at least one single or~     multiple-surface dentin caries lesion in primary or permanent molars will be selected in the~     public schools of Barueri-SP. The participants will be randomly divided into 2 groups: CT~     (Filtek Bulk Fill - 3M) and ART (Ketac Molar Easy Mix - 3M) and treated by ten untrained~     dentists in a dental office inside the schools. The restorations will be evaluated after 6,~     12 and 24 months by an independent trained and calibrated examiner. The restoration and tooth~     survival, the cost-effectiveness analysis between the two groups and the operator preference~     of the treatment regarding the techniques will be also evaluated. Kaplan-Meier survival~     analysis and log-rank test will be applied to the survival of restorations. All the average~     event rates in the two groups will be modelled and compared with a Cox proportional hazard~     shared frailty model since there is an operator cluster-effect. The significance level for~     all analyses will be 5%.~   "
76251|NCT02568904|"~     Alcohol leads to a leaky gut and translocation of bacterial products. This may lead to~     inflammation and immune dysfunction as well as the typical hangover symptoms.~   "
76252|NCT02568891|"~     In end-stage renal disease (ESRD) cardiovascular and infectious complications are common. The~     gut microbiome might play an important pathophysiological role. ESRD is hypothesized to be~     associated with profound alterations of gut microbiome and gut permeability. The~     investigators aim to test whether a multispecies probiotic mixture is able to revert the~     microbiome changes and decrease gut permeability. Furthermore the investigators aim to test~     whether this improvement in microbiome composition and gut permeability is also associated~     with improvements in endotoxemia, uremia and cardiovascular risk factors.~   "
76253|NCT02568878|"~     -  Assess the antidepressant/anxiolytic effect of creatine in male and female~          methamphetamine users~        -  Assess creatine's effect on methamphetamine use~        -  Assess the safety of creatine in male methamphetamine users with depression~   "
76254|NCT02568865|"~     This project aims to use sensors to monitor physiological signals, sleep patterns, vocal~     characteristics, activity, location and phone usage in study patients with depression who are~     receiving standard treatment (compared with healthy controls).~   "
76255|NCT02568852|"~     Pneumoperitoneum is formed with CO2 during laparoscopic abdominal operations. Effect of~     pneumoperitoneum on coagulation factors is not well known. In our study the investigators~     aimed to compare the general anesthesia(GA) and combined spinal-epidural anesthesia (CA)~     during laparoscopic cholecystectomy(LC) with effect on coagulation factors.~      Fifty patients will be randomly assigned to either the Laparoscopic cholecystectomy under~     Combined anaesthesia (25 patients) or Laparoscopic cholecystectomy under general anaesthesia~     (25 patients). All patients has symptomatic gall stone disease or polyp of gall bladder.~   "
76256|NCT02568839|"~     The purpose of this trial is to evaluate efficacy and toxicity of either the combination of~     docetaxel, trastuzumab sc and pertuzumab (arm A) or trastuzumab emtansin (arm B). Switch of~     therapy to the opposite treatment alternative is applicable in case of lack of response after~     two courses of treatment, or for medical reasons under exceptional circumstances (drug~     reaction, other medical conditions) at any point. After termination of the primary treatment~     follow-up for five years.~      A translational subprotocol is a mandatory part of the study protocol, with exception for the~     use of PET-CT evaluations.~   "
76257|NCT02568826|"~     This is a prospective cohort study, open-label, uncontrolled proof of concept trial. The~     trial objective is to evaluate the analgesic tolerability, safety and activity of IDN 5243~     (3-glycosyl-3-O-demethylthiocolchicine derivative)administered intramuscularly at 4 mg b.i.d.~     for 5 days in the morning (8.00-10.00 AM) and in the evening (6.00-8.00 PM) in subjects with~     Low Back Pain (LBP).~   "
76258|NCT02568813|"~     Epilepsy is a multifaceted disorder and a major public health problem. In addition to~     recurrent and unpredictable seizures, abnormalities in psychiatric status, cognition and~     social-adaptive behaviors are potential major sources of disability in children and adults~     with epilepsy disorders. Recent studies have unequivocally documented raised psychiatric~     comorbidities in children with epilepsy, particularly emotional regulation disorders such as~     depression and anxiety, as compared to both the general population and the children with~     other medical disorders, neurological and non-neurological. A prevalence of 12% to 35% has~     been reported, compared to 3-8% in the general population.~      Major advances have begun to uncover the potential mediators of emotional regulation~     disorders and social comorbidities in epilepsy, but important gaps remain in the early~     detection, treatment and prevention of these disorders. A very small number of investigations~     have examined children with epilepsy at or near the time of diagnosis. This is a time during~     which the effects of chronic epilepsy, potential averse social effects of epilepsy, and other~     complicating aetiological effects are minimized.~      Epilepsy syndromes provide a useful framework for considering the risk and type of emotional~     dysregulation comorbidities. But variability within and across syndromes needs to be taken~     into account thus requiring a strict phenotyping by specialists in the filed of pediatric~     epileptology. Retrospective studies, usually including patients with chronic epilepsies and~     suffering from a mixed spectrum of epilepsy syndromes introduce biases leading to rather~     disparate findings.~      Are such disorders the result of common physiopathological mechanisms, which precede the~     development of the epilepsy? The link between an underlying brain disorder and psychiatric~     comorbidities has emerged in recent literature, with evidence based on studies in adults,~     suggesting bidirectional relations between epilepsy and neurobehavioural comorbidities.~     Emotional regulation disorders can follow the onset of epilepsy, but they can also precede~     it, thus serving as a possible risk factor. The clinical implication of such a bidirectional~     association is that neurobehavioural comorbidities might be present at diagnosis and even~     before epilepsy onset. There is a need for greater understanding of the causes of these~     conditions in younger people.~      The degree to which specific epilepsy syndromes are associated with the relative risk of~     emotional dysregulation disorders in children with new- or recent-onset (within six months~     prior to enrolment) has rarely been comprehensively examined and represents the focus of the~     current investigation.~      The investigators study will be based on a prospectively recruited cohort of 280~     children/adolescents with recently diagnosed epilepsy. All participating centres dispose of~     the necessary competences for a precise diagnosis of the epilepsy syndromes and the tools for~     a per case appropriate aetiology screening. Following a first seizure children are usually~     first examined at hospital based emergency departments. Prompt referral to the epilepsy teams~     participating at the present study will significantly reduce the population biases and~     shortcuts encountered in studies that recruited patients with chronic epilepsy followed in~     tertiary care epilepsy units.~      The investigators expect their results to provide a greater understanding of both the shared~     and the unique features of emotional regulation disorders, in relation to specific epilepsy~     categories defined on the basis of the underlying physiopathological mechanisms.~      Such knowledge will also assist clinicians and families in the planning of both diagnosis and~     management resources.~   "
76259|NCT02568800|"~     It is advocated that prolonged infusion of beta-lactamic antibiotics provides better~     bactericidal effect. The aim of the present study is to randomize patients a to extended~     cefepime infusion regimen (lasting four hours) or to a usual infusion regimen (not lasting~     more than thirty minutes) and evaluate the clinical efficacy of this theoretical~     pharmacokinetic advantage.~   "
76260|NCT02568787|"~     The purpose of this study is to investigate the effects of Rice Bran Arabinoxylan Compound~     (RBAC) on outcome variables in persons with non-alcoholic fatty liver disease (NAFLD). This~     nutritional supplement is made from a water soluble extract of rice bran that has been~     partially hydrolyzed by the action of a natural enzyme complex extracted from Shiitake~     mushroom.~   "
76261|NCT02568774|"~     This study evaluates the effect of acupuncture on post-stroke overactive bladder symptoms.~     Participants will be put into groups randomly and compared. There are two groups: traditional~     acupuncture and usual care. The ratio of group allocation is 1:1.~   "
76262|NCT02568761|"~     A randomized single blind clinical trial, with a larger sample size than previous studies ,~     to evaluate the effectiveness of injection snoreplasty in the treatment of patients with~     snoring and obstructive sleep apnea/hypopnea syndrome (OSAHS) compared to oropharyngeal~     exercises, a low cost therapeutic modality.~   "
76283|NCT02568488|"~     Forty eight PCOS patients were included . The diagnosis of PCOS was made based on the three~     criteria set by the Rotterdam Consensus meeting definition of PCOS (ESHRE, ASRM, 2004). The~     criteria were as follows:~        1. history of chronic anovulation defined as cycle length > 35 days, or less than 9 cycles~          per year or amenorrhoea (cycle length > 12wks),~        2. infertility with hirsutism or acne or elevation of one or more of serum androgen levels~        3. ultrasonographic findings of polycystic ovaries ( increased ovarian volume, more than~          eight follicles in an ovary ranging from 2-10mm).~      the studied subjects were to receive metformin 850 mg twice daily over a period of 6 months.~     Blood samples were collected at the start of the study, before receiving metformin, where~     baseline serum insulin (fasting and 2 hr postprandial), sex hormone binding globulin (SHBG) ,~     total and free testosterone, Dihydroepiandrostenedione sulphate (DHEAS) and Antimullerian~     Hormone (AMH) were obtained before starting metformin. Blood samples were collected at 3 and~     6 months respectively of metformin treatment , to asses its effect on serum levels of the~     previously mentioned hormonal parameters.~   "
76263|NCT02568748|"~     Hepatocellular carcinoma (HCC) is the fifth most common malignancy in the world and the third~     most common cause of cancer-related deaths complicating liver cirrhosis in most cases. In~     Egypt, there has been a remarkable increase of the proportion of HCC among CLD patients from~     4.0% to 7.2% over a decade. This rising proportion may be explained by the increasing risk~     factors such as the emergence of HCV over the same period of time, the contribution of HBV~     infection, improvement of the screening programs and diagnostic tools of HCC as well as the~     increased survival rate among patients with cirrhosis to allow time for some of them to~     develop HCC. The only curative treatment modalities for HCC are surgery, local ablation, and~     liver transplantation which have high recurrence rate either due to viral hepatitis infection~     or cirrhosis leading to low success rate and high economic burden.~      Unfortunately, the majority of patients have unresectable disease at diagnosis. So, patients~     search for palliative very expensive therapies including chemotherapy and radiotherapy which~     often fail to eradicate tumor lesions completely and tend to result in many adverse~     events.Thus, novel approaches for treatment options are needed for patients with advanced HCC~     .~      In recent years, immunotherapy has emerged as an efficacious treatment modality with~     encouraging efficacy and slight adverse events in cancer therapy [Stroncek 2010].~     Cytokine-induced killer CIK cells therapy has been evaluated as an adoptive cell~     immunotherapy for cancer patients in a number of clinical trials and the promising efficacy~     of CIK cells on malignancies has been proved.~   "
76264|NCT02568735|"~     The main purpose of this study was to determine the plasma and central nervious system~     pharmacokinetics of dexketoprofen and etoricoxib. The secondary aim was to asses their effect~     on the concentrations of interleukin 6, prostaglandin E2 and other proinflammatory markers~     both in plasma and cerebrospinal fluid. Thirdly, the investigators aimed to evaluate their~     efficacy in postoperative pain treatment.~   "
76265|NCT02568722|"~     The objectives of this trial are to determine whether, in critically ill patients with severe~     acute kidney injury (AKI), randomization to accelerated initiation of renal replacement~     therapy (RRT), compared to standard initiation, leads to:~        1. Improved survival (primary outcome); and~        2. Recovery of kidney function (principal secondary outcome), defined as independence from~          RRT at 90 days~   "
76266|NCT02568709|"~     The specific aim of this proposal is to investigate the neurophysiological mechanisms of~     oxytocin's (OT) prosocial effects in patients with schizophrenia and healthy subjects using~     magnetoencephalography.~      Hypothesis A: When OT is administered to patients with schizophrenia, fear-related amygdala~     hyperreactivity and fusiform gyrus (FG) and anterior cingulate cortex (ACC) hypoactivity will~     be normalized.~      Hypothesis B: When OT is administered to patients with schizophrenia, the decreased~     functional connectivity (FC) between the amygdala, FG, and ACC will be normalized.~      By elucidating the neurophysiological mechanisms of OT administration on emotional face~     processing, investigators will bee able to:~        1. understand the pathophysiology of the functionally debilitating social cognitive~          deficits of schizophrenia,~        2. test the efficacy of OT in normalizing the neural abnormalities underlying these social~          deficits, and~        3. develop and optimize novel treatments for these currently untreatable deficits.~   "
76267|NCT02568696|"~     The purpose of this study is to investigate local activation of the coagulation system in the~     kidney graft during organ preservation and during early reperfusion in adult kidney~     transplantation. Generation of thrombin and fibrin as well as activation and inhibition of~     fibrinolysis will be investigated. Influence of these events on delayed graft function (DGF)~     and acute cell-mediated rejection will be evaluated.~   "
76268|NCT02568683|"~     This study will evaluate the safety of entospletinib (ENTO) with vincristine (VCR) in~     participants with relapsed or refractory B-cell Non-Hodgkin Lymphoma (NHL).~   "
76269|NCT02568670|"~     This is a two-centers, open label, prospective, randomized, noninferiority controlled trial~     with cost-effectiveness analysis to verify if is non inferior to remove peripheral~     intravenous catheter according to clinical signs in relation to every 96 hours.~   "
76270|NCT02568657|"~     Postpartum hemorrhage (PPH) is responsible for around 25% of maternal mortality worldwide~     reaching as high as 60% in some countries.~      Postpartum hemorrhage is defined as loss of 500 mL or more in a vaginal delivery and 1 Litre~     or more in a cesarean delivery.Also any blood loss that cause hemodynamic instability should~     be considered a PPH.~      In 2012, WHO updated the guidelines for the management of PPH and retained placenta to~     include: The use of intrauterine balloon tamponade is recommended for the treatment of PPH~     due to uterine atony. This recommendation is now stronger than the previous guidelines. It~     can be used for women who do not respond to uterotonics or if uterotonics are not available.~     This procedure potentially can avoid surgery and is appropriate while awaiting transfer to a~     higher-level facility.Furthermore, FIGO included Uterine balloon tamponade as a recommended~     second-line intervention for the treatment of PPH in their updated guidelines issued in 2012.~      In 2006, the ACOG Practice Bulletin, published by the American College of Obstetricians and~     Gynecologists, made mention of the Bakri postpartum balloon for its specifically tailored~     design that enables conservative management of uterine bleeding in cases of uterine atony and~     other causes of PPH.~      The reports demonstrated that balloon tamponade is helpful in managing PPH secondary to a~     wide variety of causes in resource-poor settings.~      One of the new methods that could be used to control PPH is Uterine packing with~     chitosan-covered gauze or Celox.~      Celox Haemostats are dressings with natural material called chitosan to control major~     haemorrhage including life-threatening bleeding . They are simple and effective, stopping~     major bleeding.It was first used by military forces to stop sever bleeding in the scene with~     no other options to stop bleeding. Celox™ granules are actually very high surface area~     flakes. When they come in contact with blood, Celox™ swells, gels, and sticks together to~     make a gel like clot, without generating any heat. Celox™ does not set off the normal~     clotting cascade, it only clots the blood it comes directly into contact with. Celox works on~     casualties using anticoagulants and anti-platelet therapy such as aspirin .~   "
76271|NCT02568644|"~     The main objective of the study was to evaluate ginger efficacy as an adjuvant to ketoprofen~     for the treatment of headache and other symptoms related with migraine attacks.~   "
76299|NCT02568280|"~     This trial is conducted in Europe. The aim of the trial is to investigate the postprandial~     glucose metabolism after treatment with faster-acting insulin aspart in subjects with type 1~     diabetes.~   "
76300|NCT02568267|"~     This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for~     the treatment of patients with solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene~     fusion. Patients will be assigned to different baskets according to tumor type and gene~     fusion.~   "
76301|NCT02568254|"~     This is a single-site, 8-visit, double-masked, cross-over study involving three marketed~     products as study lenses. Participants will be randomly assigned each lens type, which will~     be worn for approximately two weeks (12 +/- 2 days) each. Participants will undergo a minimum~     washout period of 3 days before entering the study and undergo a minimum 7 day washout period~     between dispensing each lens type.~   "
76272|NCT02568631|"~     The serious game JeStiMulE (Educational Game for Multisensory Stimulation of Children with~     developmental disorders), developed by the Autism Resources Center of Nice, was created to~     teach social cognition including emotion recognition in context, for children and adolescents~     with autism. In a previous study, JeStiMulE has demonstrated efficacy in a population of~     young people aged 6-17 years old with high and low levels of autism.~      According to the recommendations of the 2011 HAS, disorders of social interactions are the~     most persistent troubles of the autistic triad in life.~      It seems essential to us to be able to offer young adults with autism, rehabilitation methods~     adapted to their trouble, and to observe whether JeStiMulE could be one of them.~      This study researches the effectiveness of the serious game JeStiMulE in the improvement~     social cognition for adults with autism versus controls.~      The main goal is:~      - Comparing the improvement in social cognition among adults with autism using the serious~     game JeStiMulE or not.~      Two groups will be formed: a first one of fifteen adults with a diagnosis of autism~     objectified, this group will use JeStiMulE and will be compared to a control group of adults~     with autism, using another video game, not aimed to improve social cognition.~      The objective of JeStiMulE players will be ending the game after a learning period and two~     playing periods (with emotional words and idioms, including three modules each). The groups~     will be matched with their nonverbal IQ through Raven matrices and visual memory tasks~     (WAIS).~      The control group will also be stimulated through a video game, not specialized in improving~     social cognition.~      The primary outcome will be assessed by the emotion recognition at the FEEST of Ekman test:~     by the number of emotions recognized on faces, compared to the number of emotion presented~     through this test.~      The secondary outcomes will be:~        -  The rest of social cognition improvement by several tests (the theory of mind with the~          score of the Tom-15, the intention with the score Sarfati cartoons, empathy with a~          self-administered questionnaire: EQ / AQ).~        -  The impact on the quality of life, verbal fluency of emotional words, and the feedback~          from JeStiMulE players will also be seen as a secondary outcome.~   "
76273|NCT02568618|"~     This study utilizes the Medication DNA Insight™ tests for pain and mental health medications.~     We are testing the pain and mental health medications commonly used in pain treatment.~     Subjects will give a sample of saliva that will be tested for the metabolism of the different~     medications. Consented providers will be given the results of the test and can determine~     whether to change the subject's medication regimen. Providers and subjects will be ask to~     complete surveys both pre and post visits. The purpose is to examine provider and patient~     satisfaction, confidence and certainty of using the test results.~   "
76274|NCT02568605|"~     Non-alcoholic fatty liver disease (NAFLD) is a condition where accumulation of fat in the~     liver leads to metabolic dysfunction. Currently there are no approved treatments for NAFLD.~     Part of the metabolic dysfunction may arise through changes in the gut microbiota. Prebiotic~     fibres have beneficial effects on glucose tolerance, body weight, and gut microbiota;~     therefore they may have potential as part of a dietary strategy for NAFLD treatment.~   "
76275|NCT02568592|"~     The capacity to burn fat as fuel for exercise may have important implications for sporting~     performance, with dietary fat intake positively influencing this ability.~      Endurance performance and the ability to burn fat will be measured in women runners following~     the consumption of 3 diets varying in the amount of fat and carbohydrate.~   "
76276|NCT02568579|"~     This study will follow 40 healthy, vaginally delivered infants that are primarily (>/- 75%)~     breast fed and 40 infants that are exclusively formula fed for at least the first 4 months of~     life from birth until 12 month age. Visits - Subjects will be consented prior to delivery,~     visit 1. Subject will be seen if possible after delivery for instruction on stool collection~     and distribution of supplies, visit 2. Subject will be seen at 6 months of age post~     immunization, visit 3. Subject will be seen prior to 12 month visit. Study staff will contact~     via phone/email to collect information about feeding changes.~   "
76277|NCT02568566|"~     Human papillomavirus (HPV) is a common sexually-transmitted virus which causes infections~     that usually last only a few months, but sometimes can last a long time and cause cancers of~     the cervix, vagina, vulva, anus or oropharynx over many years among adults. This phase IIA~     trial studies how well does the nonavalent HPV vaccine (which can prevent nine different~     types of HPV) work when given in an alternative dosing schedule to heathy young research~     participants.~   "
76278|NCT02568553|"~     This phase I trial studies the side effects and best dose of lenalidomide and blinatumomab~     when given together in treating patients with non-Hodgkin lymphoma that has returned after a~     period of improvement. Biological therapies, such as lenalidomide and blinatumomab, use~     substances made from living organisms that may stimulate or suppress the immune system in~     different ways and stop cancer cells from growing.~   "
76279|NCT02568540|"~     Today's mobile devices (especially smartphones) are powerful ways to communicate new~     information to medical researchers. For this study, researchers at Boston Children's Hospital~     are asking people with hepatitis C to make use of their smartphones to help report~     information about themselves that may improve how hepatitis C is treated. This study uses a~     free app called C Tracker that can be installed from the Apple App Store onto the~     participants iPhone. The main goal of this research study is to use this app to report~     hepatitis C related health information to the researchers who are conducting this study. The~     investigators will ask participants about their health,activities, medications, and ways in~     which hepatitis C has impacted you. This information will be reported anonymously, which~     means that the researchers doing the study won't know who the participants are.~   "
76280|NCT02568527|"~     The purpose of this clinical study is to undertake a pilot safety and efficacy study of a~     synthetic biodegradable membrane as a substitute for using donor human amniotic membrane~     (hAM) for the treatment of limbal stem cell deficiency (LSCD) by combining this with freshly~     excised limbal tissue in theatre as a one stage procedure~   "
76281|NCT02568514|"~     In this study, the investigators will conduct a randomized, controlled trial to evaluate the~     impact of offering mobile secure text messaging on clinical outcomes.~   "
76282|NCT02568501|"~     In this study the investigators will compare a novel approach using daily financial~     incentives and a tiered sponsor network to motivate adolescents and young adults with type 1~     diabetes to improve glycemic control.~   "
76302|NCT02568241|"~     This study aimed to evaluate the efficacy of interferon α after prophylactic donor lymphocyte~     infusion (DLI) among high-risk acute leukemia patients undergone unmanipulated blood and~     marrow transplantation. Hematopoietic stem cell transplantation (HSCT) is an effective~     treatment option for high-risk acute leukemia (AL). However, post-transplant relapse can~     occur in some patients, and the prognosis of these patients is usually very poor.Prophylactic~     DLI can decrease the risk of relapse of high-risk AL patients. Interferon α-2b exerts a~     relatively strong immunomodulatory effect. It can kill AL cells by regulating T-cell and/or~     natural killer cell functions.Consequently, interferon α-2b may have potential value for~     high-risk AL patients after transplantation. The study hypothesis: Using interferon α-2b~     after prophylactic DLI following hematopoietic stem cell transplantation in patients with~     high-risk AL can further reduce relapse rate and improve leukemia-free survival.~   "
76284|NCT02568475|"~     This study addresses the Patient-Centered Outcomes Research Institute (PCORI) area of~     interest related to development of decision support tools that bring patients, families and~     clinicians together to decide, in this instance, whether or not transfer from the nursing~     home (NH) to acute care is necessary and appropriate. The purposes of this study were 1) to~     develop an evidence-based decision aid addressing potentially avoidable transfers of~     residents from nursing homes to hospitals (preceded this protocol), and 2) to evaluate this~     decision aid in terms of acceptability to residents and families and its effect on the~     quality of transfer decisions.~      The primary hypotheses to be tested are:~      Hypothesis 1: Resident and family members in the intervention group will report greater~     preparation for decision making and less decisional conflict than those in the no treatment~     control group.~      Hypothesis 2: Residents and family members in the intervention group will demonstrate~     increased knowledge related to acute care transfer and less preference for acute care~     transfer than those in the no treatment control group.~   "
76285|NCT02568462|"~     The purpose of this study is to evaluate the safety and performance of a new version of a~     coronary artery stent for treating blockages in the arteries supplying blood to the heart~     muscle. The Amaranth Medical APTITUDE scaffold releases a drug (sirolimus) to reduce the~     likelihood of the treated blood vessel developing a new blockage. In addition, the scaffold~     dissolves away over time, leaving no permanent implant after the blood vessel has healed.~   "
76286|NCT02568449|"~     This phase II trial studies how well nintedanib works in treating patients with malignant~     pleural mesothelioma that has come back. Nintedanib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth.~   "
76287|NCT02568436|"~     26 participants from the Orthodontic Department at University of Damascus Dental School will~     be randomly assigned into two groups. In the experimental group, a low level laser with a~     wave length of 830 nm, output of 150 mw, energy of 2 j per point and application time of 15~     seconds per point will be applied on each tooth of the six upper incisors according to this~     protocol: the root will be divided into 2 halves; gingival and cervical. Laser will be~     applied in the center of each half from both the buccal and palatal sides which means 4~     application points and a total energy of 8 j per each tooth. Control group will undergo~     typical orthodontic treatment with the laser device applied the same manner but without being~     turned on (to get the placebo effect for pain reduction effect). This procedure will be~     repeated after 3, 7, 14 days and each 15 days from the beginning of the second month till the~     end of the leveling and alignment stage.~   "
76288|NCT02568423|"~     The main purpose of this study is to explore the safety and tolerability of mirikizumab in~     healthy Japanese and Caucasian participants. The study will also estimate how much~     mirikizumab gets into the blood stream and how long it takes the body to remove it. The study~     is expected to last about 16 weeks for each participant.~   "
76289|NCT02568410|"~     Platelets are increasingly recognized as a potent and ubiquitously present source of~     inflammatory activation. Importantly, antiplatelet therapy has been shown to significantly~     reduce major adverse events such as renal injury in cardiac surgery patients. However, in~     current practice, concerns of excessive bleeding—not platelet activation and thrombosis—shape~     clinical decisions.~      The investigators have recently seen, that a significant drop in platelet numbers following~     cardiac surgery is associated with increased mortality and risk of acute kidney injury. The~     investigators hypothesize that such thrombocytopenia is a result of excessive perioperative~     platelet activation and resultant release of inflammatory and tissue injurious signals by~     activated platelets. Platelet activation will be characterized during and after cardiac~     surgery and examine its correlation with inflammatory responses and perioperative end-organ~     injury.~   "
76290|NCT02568397|"~     The purpose of this study is to learn about the effect of lanabecestat on how the body~     absorbs and processes dabigatran etexilate and how dabigatran etexilate affects lanabecestat~     when they are taken together. This study will last about 28 days and participants will be~     asked to take an lanabecestat tablet daily for 19 days and a dabigatran etexilate tablet on 3~     occasions. Screening is required within 30 days prior to the start of the study.~   "
76291|NCT02568384|"~     The purpose of this study is to assess the usability of the Onyx system in the hands of~     subjects with Insulin Dependent Diabetes Mellitus (IDDM) or insulin-using subjects with~     Non-IDDM.~   "
76292|NCT02568371|"~     The bio-Share project aims at collecting blood samples in students participating in the~     i-Share cohort (www.i-share.fr). Investigators aim at setting up a platform that will enable~     investigators in the future to study biological determinants of conditions that affect young~     adults and to test certain hypotheses on the pathophysiology and mechanisms underlying~     diseases occurring both at a young age and later in life (as early exposures may also impact~     late onset diseases)~   "
76293|NCT02568358|"~     Lung transplantation (LTx) , DNA-based testing.~      Performance of DNA-based testing of bacterial and fungal pathogens in comparison to standard~     testing.~      Experimental intervention: DNA-based testing of BAL fluid.~   "
76294|NCT02568345|"~     The purpose of this study is to determine the minimum effective dose of sugammadex, an~     antagonist of neuromuscular blockade used during anesthesia practice, in obese patients,~     considering that sugammadex is indicated in adults with normal weight at a dose of 2 mg/kg~     but no studies were found with obese patients.~   "
76295|NCT02568332|"~     This study is aimed at assessing the safety of candidate Hepatitis C (Hep C) vaccines~     AdCh3NSmut1 and MVA-NSmut when administered to Human Immunodeficiency Virus (HIV)~     seropositive individuals. This study also aims to assess the cellular immune response~     generated by these vaccines when administered as mentioned above.~   "
76296|NCT02568319|"~     This is a multi-center, randomized, placebo-controlled, double-blind study evaluating the~     safety and efficacy of LIPO-202 for the reduction of central abdominal bulging in obese~     subjects.~   "
76297|NCT02568306|"~     This trial is conducted in the United States of America. The aim of the trial is to~     investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the~     body) for single doses and multiple doses of NNC0165-1562 in overweight to obese but~     otherwise healthy subjects.~   "
76298|NCT02568293|"~     The purpose of this study is to compare balloon angioplasty plus SBCV against balloon~     angioplasty alone for treatment of stenosis within the femoropopliteal artery.~   "
76303|NCT02568228|"~     Intake of omega-3 (n-3) polyunsaturated fatty acids (PUFAs) from fish oil and fish are~     associated with significant health benefits in risk of cardiovascular disease. However, both~     lean and fatty fish have been shown to have beneficial effects suggesting that not all~     effects are mediated by n-3 PUFAs. Krill oil is an n-3 PUFA supplement on the marked. The n-3~     PUFAs from krill oil is in the form of phospholipids, and these fatty acids may be more~     readily and effectively absorbed after ingestion than n-3 PUFAs in the form of~     triacylglycerols from fish oil. Fish also contain many other potential health components than~     n-3 PUFAs such as taurine and vitamin D, iodine, selenium and more unspecified components~     such as bioactive peptides which can mediate the health beneficial effects observed after~     intake of fish.~      The present study aims to elucidate the cardiovascular health beneficial effects after~     consumption of fish (lean and fatty) and krill oil, with regard to effects on plasma lipids~     and other markers of cardiovascular health such as inflammatory, haemostatic and endothelial~     dysfunction markers. The investigators will perform whole genome transcriptome analyses in~     peripheral blood mononuclear cells (PBMCs) in order to further understand the cardiovascular~     health benefits and elucidate the mechanisms of action.~   "
76304|NCT02568215|"~     This study will evaluate the safety and efficacy of the human monoclonal antibody (mAb)~     VRC-HIVMAB060-00-AB (VRC01) in preventing HIV-1 infection in high-risk, HIV-uninfected women.~   "
76305|NCT02568202|"~     This study is conducted in the United States of America (USA). Tha aim of this study is~     bridging Hemophilia B Experiences, Results and Opportunities into Solutions (B-HERO-S).~   "
76306|NCT02568189|"~     Conduct a randomized, controlled trial looking at how the use of ultrasound analyzing the~     inferior vena cava impacts the management and outcomes of pediatric emergency department~     patients undergoing evaluation and treatment of sepsis and gastroenteritis associated~     dehydration.~   "
76307|NCT02568176|"~     The primary purpose of this study is to evaluate the induction potential of repeated~     administration of intranasal esketamine on cytochrome P450 (CYP) 3A4 and CYP2B6 activity in~     healthy participants using orally administered midazolam and bupropion as probes,~     respectively and to evaluate the pharmacokinetics of esketamine after a single dose and~     repeated administration.~   "
76308|NCT02568163|"~     Treatment of periodontal diseases is influenced by several risk factors. Psychological stress~     is considered as one of them. Aim of this study is to assess if stress influences results of~     non surgical periodontal treatment in severe chronic forms of periodontitis.~   "
76309|NCT02568150|"~     Evaluate onset time and safety of improvement effect of each group's forehead wrinkles after~     2, 3, 4, 5, 14 days from administration of 20U dosage of DWP450-004 for adult patients who~     need more than moderate improvement of forehead wrinkles.~   "
76310|NCT02568137|"~     This research seeks to develop a culturally-acceptable, effective, and sustainable way of~     utilizing the rapidly growing penetration of mobile phones among people in Sub-Saharan Africa~     (SSA), to improve the currently poor control of hypertension among patients at high risk for~     future stroke. It also aims to develop human capital in SSA to conduct locally-relevant,~     high-quality stroke research in the future. Specifically, this study will preliminarily test~     a strategy that incorporates mobile phone texting and home blood pressure monitoring directed~     by trained nurses, to improve patient adherence to proven medical therapies for treating~     hypertension.~   "
76311|NCT02568124|"~     BACKGROUND Chronic subdural hematoma (CSDH) is one of the most frequent reasons for cranial~     neurosurgical consult. There is no widely accepted medical treatment for CSDH.~      This trial will investigate whether Tranexamic Acid (TXA) can increase the rate of CSDH~     resolution following conservative management, lower the number of required surgical~     procedures and decrease the rate of CSDH recurrence following surgical evacuation. TRACS is a~     double blind, randomized, parallel-design, placebo-controlled, phase IIB study designed to~     provide preliminary efficacy data as well as feasibility, safety and incidence data required~     to plan a larger definitive phase III trial.~      METHODS Consecutive patients presenting at the Centre Hospitalier Universitaire de Sherbrooke~     with a recent (< 14 days) diagnosis of subdural hematoma with a chronic component will be~     screened for eligibility. Exclusion criteria include specific risk factors for thromboembolic~     disease, anticoagulant use or contraindication to TXA. A total of 130 patients will be~     randomized to receive either 750 mg of TXA daily or placebo until complete radiological~     resolution of the CSDH or for a maximum of 20 weeks. CSDH volume will be measured on serial~     CT scanning. Cognitive function tests, quality of life questionnaires as well as functional~     autonomy assessments will be performed at enrollment, 10 weeks follow-up and 3 months~     post-treatment follow-up. During the treatment period, patients will undergo standard CSDH~     management with surgery being performed at the discretion of the treating physician. If~     surgery is performed, the CSDH and its outer membrane will be sampled for in vitro analysis.~      The primary outcome is the rate of CSDH resolution at 20 weeks without intervening unplanned~     surgical procedure. Secondary outcomes include CSDH volume, incidence of surgical evacuation~     procedures, CSDH recurrence, cognitive functions, functional autonomy, quality of life,~     incidence of complications and length of hospital stay. Planned subgroup analyses will be~     performed for conservatively vs surgically-managed subjects and highly vs poorly vascularised~     CSDH.~      DISCUSSION CSDH is a frequent and morbid condition for which an effective medical treatment~     has yet to be discovered. The TRACS trial will be the first prospective study of TXA for~     CSDH.~   "
76312|NCT02568111|"~     The primary objective of this study is to evaluate the Injection Related Erythema (IRE)~     mitigation effect of a single administration of brimonidine tartrate in comparison with a~     vehicle gel (placebo).~      The secondary study objectives are to evaluate the IRE mitigation effect of a single~     administration of brimonidine tartrate in comparison with a vehicle gel on a more stringent~     definition scale, in accordance with the primary endpoint of the original brimonidine pivotal~     trials and participants' satisfaction with the overall appearance of their skin.~   "
76313|NCT02568098|"~     Primary Objective~        -  To evaluate the safety and tolerability of co-administered single dose~          Dihydroartemisinin-Piperaquine (DHA-PQP), Ivermectin (IVM), Primaquine (PQ), and~          Albendazole (ABZ) in healthy subjects.~      Secondary Objectives~        -  To characterize the potential pharmacokinetic interactions between DHA-PQP, IVM, PQ, and~          ABZ in healthy adult subjects.~        -  To characterize the pharmacokinetic properties of PQ (and its major metabolite),~          DHA-PQP, IVM, and ABZ (and its major metabolite) when given alone and in combination.~        -  To investigate pharmacogenetic polymorphisms affecting drug levels of PQ, DHA-PQP, IVM,~          ABZ and their metabolites.~        -  To determine mosquito lethal efficacy of IVM, PQ, ABZ, and DHA-PQP combinations against~          Anopheles dirus and Anopheles minimus.~        -  To determine if IVM concentrations in venous blood differs from capillary blood.~   "
76494|NCT02565745|"~     Study purpose:~      To assess if - in adult patients admitted to hospital with surgical or medical conditions at~     high/very high risk of developing pressure ulcers (PU) according to Braden scale - using skin~     dressing protection versus conventional care (lubricant or moisturizer cream) may prevent the~     incidence of in-hospital PU~   "
76314|NCT02568085|"~     This is a single-blinded randomized controlled trial to evaluate the effectiveness of Arista~     hemostatic matrix powder (Arista® AH, C. R. Bard, Inc. Davol, Warwick, RI) in reducing~     drainage output after total thyroidectomy with and without lateral neck dissections.~     Increased drainage in total thyroidectomy and neck dissection wound beds can lead to seroma~     formation with possible secondary infection, delayed hospital discharge, and additional home~     care needs for drain care. Arista is an inert plant based absorbable surgical hemostatic~     powder that can be easily applied to broad surgical fields to reduce bleeding and seroma~     rates. Therefore, its application to thyroidectomy and neck dissection wound beds may bear~     significant potential benefit.~   "
76315|NCT02568072|"~     This project will expand on research conducted by the investigators' group, where the~     investigators have demonstrated increased LV trabeculation, satisfying currently existing~     criteria for LV Non-Compaction Cardiomyopathy (LVNC), in groups exposed to high cardiac~     workloads. To the investigators' knowledge, this will be the first prospective study aiming~     to demonstrate a direct relationship between high levels of exercise and increased LV~     trabeculation. This study may add weight to the theory that this entity currently described~     as LVNC, is a morphological epiphenomenon common to many distinct myocardial remodeling~     processes associated with increased cardiac preload and afterload and may better define~     normal adaptive increases in LV trabeculation.~   "
76316|NCT02568059|"~     The clinical safety of Sahastara remedy alcoholic extract in healthy volunteers.~     Investigators will investigate safety of 100 and 200 mg of Sahastara remedy extract capsule~     in healthy volunteers. This is Clinical trial Phase I.~   "
76317|NCT02568046|"~     This is a phase 1b/2a study investigating the safety and effect of Sym004 in combination with~     FOLFIRI (chemotherapy) when administered every second week.~   "
76318|NCT02568033|"~     This is a pilot study looking at using stereotactic radiosurgery and full dose chemotherapy~     to treat stage II and III lung cancer that is not amendable to surgical resection.~   "
76319|NCT02568020|"~     To investigate the effects of different dietary regimens on muscle wasting, insulin/IGF-1~     resistance. Further, to explore whether LPD+KA decrease the activation of autophagy associate~     with insulin/IGF-1 pathway.~   "
76320|NCT02568007|"~     The purpose of this study is to examine the effect of standard dosing of cyproheptadine for~     both cycled and continuous administration, as compared to no medication, on appetite~     stimulation and growth in the pediatric gastroenterology feeding team patient population. The~     secondary aim is to evaluate the effect, if any, of the suspected tachyphylaxis that is~     commonly associated with cyproheptadine use. The third aim will be to examine the type and~     duration of side effects of cyproheptadine in this population. The ultimate goal will be to~     create a standardized protocol for cyproheptadine therapy in children with feeding disorders~     and suboptimal growth.~   "
76321|NCT02567994|"~     After a screening, a 2-week, single-blind placebo run-in, 200 patients will be randomized in~     a 1 : 1 ratio to the addition of either once-daily Teneligliptin 20mg or sitagliptin 100mg to~     ongoing stable doses of glimepiride in combination with metformin for 24 weeks.~   "
76322|NCT02567981|"~     Adequate nutrition during the first years of life is essential to reach full body and brain~     development potential. Children under the age of 5 in Central America and El Salvador suffer~     from micronutrient deficiencies. In El Salvador, ~ 20% of children under the age of 5 suffer~     from chronic undernutrition which is reflected in low length-for-their age Z-scores and~     anemia. This trial will examine the impact on health and growth in young children that will~     receive either a 21 micronutrient fortified cereal/legume mix manufactured in Guatemala or~     the current standard of nutritional care. The ultimate goal is to identify other feasible and~     effective alternatives to prevent micronutrient deficiencies through culturally acceptable~     vehicles.~   "
76323|NCT02567968|"~     At present clinicians have no way to reverse anesthesia. Patients wake when their bodies~     clear the anesthetic. Most people wake quickly, but some do not. All patients have memory and~     other cognitive problems after waking from anesthesia. In studies on animals, the~     investigators observed that caffeine caused rats and mice to wake much more rapidly from~     anesthesia. This was true for all the animals tested. The investigators would like to see if~     this holds true in humans. Will caffeine accelerate waking from anesthesia? Will it reverse~     the cognitive deficits associated with anesthesia, after waking?~      The investigators carried out a modest trial with 8 test subjects. Each volunteer was~     anesthetized twice. Each volunteer was anesthetized one time and received an infusion of~     saline (placebo control), without the aid of any other drugs and the other time the volunteer~     received an infusion of a relatively low dose of caffeine. The order of saline versus~     caffeine was randomized and the study was done in a double blind manner. We observed that~     emergence from anesthesia was significantly accelerated by the caffeine infusion. No adverse~     events were observed.~   "
76324|NCT02567955|"~     A ninevalent HPV vaccine (Gardasil-9) has been recently approved for clinical use. No data on~     immunogenicity and safety of interchangeable use of the ninevalent and the bivalent vaccine~     (Cervarix) are available. The main objective of this study is to assess the immunogenicity of~     ninevalent and bivalent HPV vaccines when administered to 9-10-year-old girls and boys~     according to 0-6 month schedule.~   "
76325|NCT02567942|"~     Anesthetics agents has variety inflammation during the cancer surgery. This perioperative~     inflammation can influence to cancer metastasis or recurrence.~      The purpose of this study is to prove the variation of immune cell activity between~     preoperative and postoperative period.~   "
76326|NCT02567929|"~     Anesthetics agents has variety inflammation during the cancer surgery. This perioperative~     inflammation can influence to cancer metastasis or recurrence.~      The purpose of this study is to prove the variation of immune cell activity between~     preoperative and postoperative period.~   "
76327|NCT02567916|"~     The purpose of this study is to compare the incidence and intensity of possible pain on~     injection as well as patient satisfaction caused by long chain triglyceride propofol versus~     medium/long chain combinated triglyceride propofol on endoscopy.~   "
76361|NCT02567474|"~     This study evaluates the effectiveness of self management programs based on 5A model on the~     lung function status, dyspnea and exercise tolerance in Chronic Obstructive Pulmonary Disease~     patients. Participants were randomly assigned to an intervention group or a control group.~     The control group were receiving standard practice care and the intervention group were~     receiving intervention in addition to standard practice care. The intervention content~     include implementation of a self management plan based on 5A model.~   "
76328|NCT02567903|"~     Knee arthroscopy is the most commonly performed orthopaedic procedure worldwide, with,~     according to the American Society for Sports Medicine, over 4 million procedures performed~     each year. The risk of venous thrombosis following this procedure is considerable with rates~     of symptomatic events varying between 0.9% and 4.6%. It is currently unknown how this high~     risk comes about considering its short duration and minimal tissue damage caused by the~     procedure. A factor that may play a role is the use of a tourniquet. A large majority of~     orthopaedic surgeons prefer to operate within a 'dry field', which is obtained by the use of~     a tourniquet. Tourniquet applied surgery is not without risks. Although its use during~     orthopedic surgery is widely accepted and a standard procedure, tourniquet use can lead to~     loss of muscle functional strength and contractile speed, vessel wall damage and nerve~     injury, next to the possibly increased risk of venous thrombosis. In the proposed study the~     investigators will investigate the effect of a tourniquet on local and systemic markers of~     hypoxia, inflammation, involvement of endothelium, and coagulation activation. A finding of~     more prominent activation of the coagulation system with tourniquet use than with non-use~     will create an important opportunity to prevent thromboembolic events in these patients, as~     it has been shown that knee arthroscopy can be performed adequately without the use of a~     tourniquet. Furthermore, it will increase the understanding of the pathophysiology of~     thrombosis.~   "
76329|NCT02567890|"~     Women in general and young girls in particular are constantly exposed to unhealthy body and~     appearance ideals through media that contribute to body dissatisfaction and unhealthy~     behaviors such as rigid dieting, which in interaction with genes and other factors increase~     the risk of developing eating disorders such as anorexia nervosa and bulimia nervosa. The~     investigators aim is to investigate the extent to which an interactive prevention program,~     delivered through Internet, called the Swedish Body Project (sBody Project) can decrease the~     emergence of eating disorders among young females. The sBody Project is based on a~     Dissonance-Based Intervention: (DBI) that has shown very promising results. The adaptations~     and changes in the format of delivery accomplished in this study might help to disseminate~     the program on a broad basis, and consequently affect the health of young females on a much~     larger scale the ever before.~   "
76330|NCT02567877|"~     Patients taking thyroid hormone replacement after thyroid removal surgery often report~     feeling differently than they did prior to taking thyroid hormone. The symptoms can include~     fatigue, worsening mood or subjective brain fog where the patient feels like their thinking~     is just not as sharp as it was previously. Multiple studies have found that patients taking~     thyroid hormone replacement have a diminished quality of life compared to matched controls.~     Previous studies have suggested that the type of deiodinase (DIO) polymorphism a patient has,~     which is responsible for converting the thyroid hormone T4 into the more biologically active~     T3, may contribute to their overall cognition and sense of well-being. The Investigators aim~     to determine if the type of deiodinase polymorphism a patient has contributes to the~     patient's cognition and overall sense of well-being after surgery and thyroid hormone~     replacement.~      Objective: Determine if patients with the deiodinase type 2 CC polymorphism have objective~     differences in working memory (N-back test is primary endpoint), cognitive function and sense~     of well-being after thyroidectomy when placed on standard thyroid hormone replacement~     therapy.~      Hypotheses: (1) Patients with the deiodinase type 2 CC polymorphism will have worse working~     memory (N-back test is primary endpoint), cognitive function and sense of well-being on~     standard thyroid hormone replacement therapy after thyroidectomy compared with before~     thyroidectomy.~      (2) Patients with the deiodinase type 2 TT or TC polymorphism will have no differences in~     working memory, cognitive function or sense of well-being on standard thyroid hormone~     replacement before and after thyroidectomy.~   "
76331|NCT02567864|"~     The goals of this research project were: 1) to develop a senior-tailored Healthy Beat~     Accupunch (HBA) exercise program for community-dwelling older adults, 2) to test the effects~     of a six-month, instructor-led HBA exercise program, and 3) to evaluate the feasibility,~     compliance, and long-term effects of a six-month, DVD-guide HBA exercise program.~   "
76332|NCT02567851|"~     An early phase II, single arm, two stage study, to investigate the level of activity,~     duration of response and tolerability of brentuximab vedotin (SGN-35), as a single agent,~     utilising a response adapted approach, in older, frailer or co-morbid patients with~     previously untreated Hodgkin lymphoma.~      Opened Feb 2014 and will recruit over 18 months. Duration of treatment will be dependent on~     the patients' response (see schema below) with a maximum of 16 cycles over 48 weeks.~      At the end of treatment patients will be assessed clinically at 3 months intervals and by CT~     scan at 15, 18, 24 and 36 months. For those still alive and disease free after 2 years,~     follow-up will be according to local practice.~   "
76333|NCT02567838|"~     The aim of this clinical trial is to evaluate the use of topical lidocaine gel in reducing~     pain associated with transrectal ultrasonography (TRS) in gynecologic field.~   "
76334|NCT02567825|"~     To determine whether tympanostomy tube placement (TTP) compared with nonsurgical management~     will meaningfully improve children's acute otitis media (AOM) experience over the succeeding~     2 years.~   "
76335|NCT02567812|"~     The aim of this prospective study is to collect data on in-patients with pelvic inflammatory~     disease(PID) at Kangbuk Samsung Hospital.~   "
76336|NCT02567799|"~     The purpose of this study is to determine the safety and effectiveness of BIO 300 Oral~     Suspension when used in combination with standard dose radiation therapy and chemotherapy in~     patients with non-small cell lung cancer. Based on preclinical data the investigators~     hypothesize that BIO 300 Oral Suspension will reduce the incidence of radiation-induced~     pneumonitis and pulmonary fibrosis.~   "
76337|NCT02567786|"~     Coagulation abnormalities after pediatric open-heart surgery are complex and very often~     multifactorial. Besides the cardiopulmonary bypass (CPB), the congenital pathology and the~     coagulation tests during CPB, the younger age has been the most significant risk factor for~     bleeding and transfusion requirements. In children the volume of pump priming is much higher~     compared with the patient's circulating blood volume. For this reason the CPB tubing system~     is primed with packed red blood cells and fresh frozen plasma (FFP) to avoid excessive~     hemodilution and induced coagulopathy. While this is routinely performed in neonates and~     small infants, the routine priming of CPB system with FFP has been questioned in several~     randomized prospective studies in older infants. However, the results of these studies are~     conflicting. Moreover, they show methodological issues.~   "
76338|NCT02567773|"~     GSK2881078 is a selective androgen receptor modulator (SARM) that is being evaluated for~     effects on muscle growth and strength in subjects with muscle wasting to improve their~     physical function. Part A of this study will evaluate the safety, efficacy and~     pharmacokinetics of GSK2881078 in healthy, older men and post-menopausal women who will take~     daily dosing for 28 days and be followed for a total of 70 days. Part B of this study will~     characterize the effect of Cytochrome P450 3A4 (CYP3A4) inhibition on the GSK2881078~     pharmacokinetics. Part B will only be conducted if safe and efficacious dose is identified in~     Part A. Part A will include healthy older males and post-menopausal females; and randomize~     approximately 60 subjects (about 15 per cohort [4 cohorts]) to complete approximately 48~     (about 12 per cohort). Part B will enroll one cohort of approximately 15 healthy male~     subjects to complete approximately 12. The study duration will be approximately 115 days for~     Part A and 122 days for Part B.~   "
76339|NCT02567760|"~     This study is set up to determine the cognitive enhancing effect and consumption safety of~     the novel cognitive enhancement product made from the combined extract of Z. mays (purple~     color) and P. amaryllifolius based-drink (MP1) in menopausal volunteer.~   "
76340|NCT02567747|"~     The purpose of this study is to provide data on trends of morbidity due to Acute Otitis Media~     (AOM) (primary analysis) and morbidity and mortality due to pneumonia, and AOM related health~     care resources before and after the introduction of vaccination against pneumococcal disease~     within the Universal Mass Vaccination (UMV) in Colombia.~   "
76341|NCT02567734|"~     Irreversible electroporation (IRE) is an emerging nonthermal focal ablation technique that~     uses a series of short but intense electric pulses delivered by NanoKnife generator through~     paired electrodes into a targeted region of tissue, inducing the cells death by apoptosis~     through irreversibly disrupting cellular membrane integrity. This study aimed to investigate~     the safety and efficacy of CT-guided percutaneous irreversible electroporation（IRE） in the~     treatment of patients with locally advanced tumors in different anatomical position.~   "
76342|NCT02567721|"~     The purpose of this study is to conduct a pilot study to explore the potential use of~     routinely collected data in General Practitioner (GP) practices to conduct enhanced safety~     surveillance of seasonal influenza vaccines in the UK, as recommended in the EMA interim~     guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU.~   "
76343|NCT02567708|"~     This study is a multi-centre, randomised, double-blind, placebo-controlled (with rescue~     medication), two period crossover study in subjects with persistent uncontrolled asthma,~     currently not treated with an inhaled corticosteroid (ICS) or long acting beta 2 agonist~     (LABA). This study is the first administration of GSK2269557 to asthmatic subjects, and the~     aims of the study are to investigate the efficacy, safety, tolerability, and pharmacokinetics~     of four weeks of treatment with orally inhaled GSK2269557 1000 microgram (mcg) in subjects~     with persistent uncontrolled asthma. In a sub-study, biological mediators will be measured~     from induced sputum and blood.~      Approximately 50 subjects will be randomised into the study (including approximately 16~     subjects in the sputum sub-study). Each subject will complete two treatment periods: subjects~     will be randomised to receive GSK2269557 1000 mcg in one treatment period, and matching~     placebo in the other treatment period. Each treatment will be administered once daily for 28~     days (+/- 2 days) via the DISKUS™ dry powder inhaler (DPI).~      The study will consist of a Screening Visit; a Run-in Period (approximately 2 weeks in~     duration); two 28-day Treatment Periods (each with 4 clinic visits); a 4-week Washout Period~     (between the Treatment Periods); and a Follow-up Visit. The total duration of the study for~     each subject will be approximately 16 weeks. DISKUS is a registered trademark of the~     GlaxoSmithKline group of companies.~   "
76344|NCT02567695|"~     The purpose of this study is to evaluate the relative bioavailability of a single 300 mg dose~     of GBT440 administered as a high strength (1 × 300 mg) capsule versus a low strength (3 × 100~     mg) capsule formulation in healthy fasted subjects.~   "
76345|NCT02567682|"~     The purpose of this study to evaluate the effect of concomitant administration of GBT440 on~     caffeine (a CYP1A2 probe substrate), S warfarin (a CYP2C9 probe substrate), omeprazole (a~     CYP2C19 probe substrate), and midazolam (a CYP3A4 probe substrate) plasma concentrations.~   "
76346|NCT02567669|"~     This study examines the extent of systemic muscle loss and the degree of fatigue experienced~     by breast cancer patients undergoing radiotherapy. This study seeks to identify whether~     muscle loss occurs outside the radiation fields and if muscle loss is correlated with the~     degree of fatigue.~   "
76347|NCT02567656|"~     The purpose of this study is to evaluate the safety, PK and efficacy of RP6530, a dual PI3K~     delta/gamma inhibitor in patients with relapsed and refractory T-cell Lymphoma.~   "
76348|NCT02567643|"~     This study is designed to determine outcome for patients with 5 or more central nervous~     system (CNS) metastatic lesions treated with stereotactic radiosurgery (SRS).~   "
76349|NCT02567630|"~     This is a prospective interventional study involving young children who will all receive~     non-invasive, passive assessments of sensory and motor function. In addition a subpopulation~     of young children with cerebral palsy will participate in a randomized controlled trial of~     constraint-induced movement therapy, a routinely prescribed therapy used in clinical practice~     for children with motor difficulties. The study attempts to apply a rigorous scientific~     approach to study a widely used but poorly studied practice. The design is an RCT with~     wait-list controls to allow all children to benefit from the therapy, even if they are~     randomized to the control group. All children, regardless of group allocation will continue~     with their standard of care occupational and physical therapy throughout the study.~   "
76350|NCT02567617|"~     The aim of this study was to evaluate the effect of polyphenol supplementation on plasma~     levels of prostaglandin E2 in women during the reproductive period.~   "
76351|NCT02567604|"~     This study will explore experience of AMD caregivers in order to develop a core outcome set~     (COS) for age related macular degeneration (AMD) randomised controlled trials (RCTs) trying~     to capture what research outcomes are important from their perspective.~      People 18 years of age and older who have been AMD caregivers for at least 6 months may be~     eligible for this study.~      The aim is to conduct three focus groups lasting approximately one hour. The plan is to enrol~     18-24 participants (6-8 participants per each of 3 focus groups).Two researchers will be~     involved in conducting the focus groups. A moderator will ensure fluid discussion, while the~     second investigator will be taking notes and audio-recording the discussion.~   "
76352|NCT02567591|"~     Physical exercise has been identified as a major beneficial factor in the management of~     patients suffering from many chronic diseases especially cancer and in the context of cardiac~     or pulmonary transplantation. It contributes to an improvement of the quality of life and~     decreases treatment side effects and mortality. Aerobic fitness is constantly altered in~     cirrhotic patients and correlated to the severity of the hepatic disease. Moreover, in this~     setting, other etiological factors may be added like chronic obstructive bronchitis and~     alcoholic cardiomyopathy. In this population, muscle abnormalities with fatigue and cramps~     have been described. Muscle weakness in this condition may be comparable to that described in~     patients with chronic obstructive bronchitis and contributes to the decrease of aerobic~     fitness. Different causes such as muscle deconditioning, hypoxemia, denutrition,~     anti-rejection drugs increase this phenomenon after liver transplantation. Finally, the~     aerobic capacity or VO2max is a prognostic factor for survival and is linked to the number~     and the length of hospitalizations after liver transplantation (LT).~      Therefore, physical activity is a valid and relevant way to improve quality of life, increase~     survival, and limit costs of hospitalizations. The aim of this study is to assess the effects~     of a personalized physical activity retraining program on aerobic capacity, strength and~     fatigue, in a population awaiting liver transplantation.~      Purpose: The hypothesis is that an at home adapted retraining program conducted before LT,~     and including physical activity (aerobic and strength training), will improve aerobic~     fitness, peripheral strength, quality of life and decrease the hospitalization length in~     intensive care unit after LT.~   "
76353|NCT02567578|"~     This is a multicenter, randomized, double-blind, placebo-controlled dose-finding phase 2~     trial to evaluate the efficacy and safety of YH12852 in patients with functional dyspepsia.~   "
76354|NCT02567565|"~     This study will compare cataract patients before and after phacoemulsification. Evaluations~     will be performed before and 1 and 3 months following cataract surgery, including measurement~     of tear film lipid layer thickness, tear film break up time, Schirmer test, corneal and~     conjunctival fluorescein staining, examination of lid margins and meibomian glands, and the~     Ocular Surface Disease Index.~   "
76355|NCT02567552|"~     Study the endometrial predecidualization by using subcutaneous progesterone 25 mg/day versus~     intramuscular progesterone 50 mg/day, to determine whether there are differences in the~     endometrial transformation and endometrial receptivity.~   "
76356|NCT02567539|"~     The study is aimed to evaluate efficacy and safety of re-irradiation for patients with~     recurrent high grade gliomas after other treatment.~   "
76357|NCT02567526|"~     Inadequate food and fluid intake is a common problem among nursing home (NH) residents and~     one that can lead to under-nutrition, dehydration, weight loss, hospitalization, and even~     death. The most common nutrition intervention for at-risk NH residents is oral liquid~     nutrition supplementation, although, there is limited controlled evidence of the efficacy of~     supplements in promoting weight gain in NH residents. Moreover, studies show that supplements~     are not provided consistent with orders and residents receive little to no staff assistance~     to promote consumption in daily NH care practice. The result is that nutritionally at-risk NH~     residents with supplement orders receive few additional daily calories from supplements.~     Recent evidence strongly suggests that offering residents a choice among a variety of foods~     and fluids multiple times per day between meals coupled with assistance is effective in~     increasing daily caloric intake and promoting weight gain. However, the provision of the~     between-meal choice intervention requires significantly more staff time relative to the~     amount of time NH staff currently spend on between-meal nutritional care provision.~      A new federal regulation allows NHs to train non-nursing staff to provide feeding assistance~     care. Preliminary research has demonstrated that non-nursing staff trained as feeding~     assistants provide mealtime feeding assistance care that is comparable to or better than~     their indigenous nurse aide counterparts. Moreover, a recent demonstration project showed~     that these staff can be used to effectively augment nurse aide staff for mealtime feeding~     assistance care provision in daily care practice. The proposed translational study will~     utilize the federal regulation to train non-nursing staff for between-meal nutritional care~     delivery. Specifically, the proposed study will use a controlled, intervention design to~     determine the cost-effectiveness of the between-meal choice intervention relative to a usual~     care control group in a group of 200 residents across 4 NH sites. Residents with an order for~     caloric supplementation will be included in this study and randomized into either a usual~     care control group or a choice intervention group (100 residents per group). The usual care~     control group will continue to receive standard NH care for supplement or snack delivery~     between meals, as provided by indigenous nurse aide staff. Non-nursing staff trained as~     feeding assistants will offer residents in the intervention group a choice between~     supplements and other snack foods and fluids twice daily, five days per week, for 24 weeks~     while also providing a standardized prompting protocol to enhance intake and independence in~     eating. Research staff will independently document the costs of intervention implementation~     and compare these costs to effectiveness measures which include improvements in caloric~     intake, weight and quality of life. These outcomes will be independently monitored for both~     groups across 24 study weeks by trained research staff using standardized, validated~     protocols. This translational research effort will provide critical information to improve~     care practices in nursing homes for nutritionally at risk residents.~   "
76358|NCT02567513|"~     Low oral food and fluid intake and unintentional weight loss are common problems among~     long-stay nursing home (NH) residents and are associated with adverse, costly clinical~     outcomes. This study will use a controlled, intervention design to determine the~     cost-effectiveness of oral liquid nutrition supplements with an alternative nutrition~     intervention that offers NH residents a choice between supplements and other foods and fluids~     (i.e., snacks) between meals in a group of 200 residents across 4 NH sites. Residents with an~     order for supplementation will be included in this study and randomized into one of three~     groups: (1) usual care control; (2) oral liquid nutrition supplementation intervention; or~     (3) choice intervention. The usual care control group will continue to receive standard NH~     care for supplement or snack delivery. Research staff will provide the same supplements used~     by the NH (group two) or a choice between supplements and other foods and fluids (group~     three) twice daily, five days per week, for 24 weeks and document the daily costs of~     intervention implementation when also providing a prompting protocol known to improve intake~     and enhance independence in eating. Based on extensive preliminary data, it is anticipated~     that both groups two and three will require significantly more staff time than usual care~     (group one). Thus, the labor costs of these interventions will be documented and compared to~     effectiveness measures. Effectiveness measures include the following resident outcomes:~     improvements in total daily caloric intake, weight, nutrition and hydration status and~     quality of life. These outcomes will be independently monitored for all three groups across~     24-weeks by trained research staff using standardized, validated protocols.~   "
76359|NCT02567500|"~     The aim of this study is to show presence of cognitive and emotional factors on the beginning~     and persistence of auditory hallucinations in non-psychotic children. Investigators will~     describe a significant link between this factors and hallucinations in a sample of~     non-psychotic children. The results of this sample will be comparing to another group of~     children of the same age, sex and diagnosis, but without hallucination. Finally,~     investigators will control the persistence of hallucination on the first group after a six~     month period.~   "
76360|NCT02567487|"~     The aim of the current study is to investigate the effects of two different doses of~     levobupivacaine in TAP (transversus abdominus plane) block for postoperative management. For~     this purpose we planned to include 50 children aged between 2 and 12 that will undergo~     unilateral inguinal surgery.~      The doses that will be used in the study were within usual dose limits which is stated in~     prospectus of the study drug.~   "
76362|NCT02567461|"~     It is not uncommon that patients requiring dual antiplatelet therapy (DAPT) also need to be~     treated with oral anticoagulant therapy, such as those with atrial fibrillation (AF).~     Warfarin and clopidogrel are still the most widely utilized oral anticoagulant and P2Y12~     receptor inhibitor, respectively. However, over the past years, several non-vitamin K~     antagonist oral anticoagulants, including edoxaban, have been studied in the setting of AF~     showing encouraging safety and efficacy profiles as compared with warfarin. However, the~     effects of edoxaban in combination with DAPT in the setting of patients with coronary artery~     disease (CAD) are unexplored. Moreover, the role of edoxaban as part of a dual antithrombotic~     treatment strategy, including clopidogrel and stopping aspirin, represents another important~     area of clinical interest. This investigation is a prospective, randomized, parallel-design,~     open label, pharmacodynamic study conducted in patients with CAD on DAPT with aspirin and~     clopidogrel testing two different edoxaban dosing regimens in addition to DAPT with aspirin~     and clopidogrel, as well as in combination with clopidogrel only (after stopping aspirin).~   "
76363|NCT02567448|"~     The purpose of study is to evaluate the physiologic effects of pulmonary tissue/structural~     changes associated with COPD and upper airway inflammation on upper airway collapsibility.~     Upper airway collapsibility is closely associated with development of obstructive sleep apnea~     (OSA), which is a common disease characterized by repetitive collapse of upper airway during~     sleep, leading to hypoxemia and arousal. OSA has important neurocognitive and cardiovascular~     consequences, especially in patients with COPD.~      Participants in this research study will undergo two overnight sleep studies (PSGs),~     pulmonary function test, and CT scan of the upper airway and chest. The first sleep study~     will evaluate the sleep breathing disorder and the second sleep study will measure the upper~     airway collapsibility, called critical closing pressure (Pcrit). Pcrit is measured by a~     modified continuous positive airway pressure (CPAP) machine which can provide a wide range of~     pressures between 20 and -20 cmH2O in order to modify upper airway pressure.~   "
76364|NCT02567435|"~     This randomized phase III trial studies how well combination chemotherapy (vincristine~     sulfate, dactinomycin, cyclophosphamide alternated with vincristine sulfate and irinotecan~     hydrochloride) works compared to combination chemotherapy plus temsirolimus in treating~     patients with rhabdomyosarcoma (cancer that forms in the soft tissues, such as muscle), and~     has an intermediate chance of coming back after treatment (intermediate risk). Drugs used in~     chemotherapy work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Combination~     chemotherapy and temsirolimus may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. It is not yet known whether combination chemotherapy or~     combination chemotherapy plus temsirolimus is more effective in treating patients with~     intermediate-risk rhabdomyosarcoma.~   "
76365|NCT02567422|"~     This phase I trial studies the side effects and best dose of ATR kinase inhibitor VX-970~     (VX-970) when given together with cisplatin and radiation therapy in treating patients with~     human papillomavirus negative (HPV) (-) head and neck squamous cell carcinoma that has spread~     from where it started to nearby tissue or lymph nodes. ATR kinase inhibitor VX-970 may stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used~     in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.~     Giving ATR kinase inhibitor VX-970 together with cisplatin and radiation therapy may work~     better in treating patients with locally advanced HPV-negative head and neck squamous cell~     carcinoma.~   "
76366|NCT02567409|"~     This randomized phase II trial studies how well cisplatin and gemcitabine hydrochloride with~     or without ATR kinase inhibitor VX-970 works in treating patients with urothelial cancer that~     has spread to other places in the body. Drugs used in chemotherapy, such as cisplatin and~     gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either~     by killing the cells, by stopping them from dividing, or by stopping them from spreading. ATR~     kinase inhibitor VX-970 may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. It is not yet known if cisplatin and gemcitabine hydrochloride work~     better alone or with ATR kinase inhibitor VX-970 in treating patients with urothelial cancer.~   "
76367|NCT02567396|"~     This phase I trial studies the side effects and best dose of talazoparib in treating patients~     with solid tumors that have spread to other places in the body and usually cannot be cured or~     controlled with treatment (advanced) or have spread to other places in the body (metastatic)~     and cannot be removed by surgery and liver or kidney dysfunction. Talazoparib may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
76368|NCT02567383|"~     Clinical experience of with hyperthermia combined with radiotherapy and chemotherapy for~     recurrent head and neck cancer is limited. The primary goals of hyperthermia combined with~     CCRT on recurrent head and neck cancer are tumor response rate, while secondary goals are~     rates of acute and late adverse effects, local control rate, distant metastasis rate,~     progression-free rate and overall survival rate.~   "
76369|NCT02567370|"~     The purpose of this study is to find out the time it takes to absorb, distribute, breakdown~     and remove the drug from the body, safety and tolerability of AMG 581 in healthy participants~     and subjects with schizophrenia.~   "
76370|NCT02567357|"~     'PREDICTORS' (Parents Resources for Decreasing the Incidence of Change Triggered Temper~     Outbursts) aims to evaluate web-based training packages for caregivers of children who show~     frequent temper outbursts following changes to their routines and plans. The training~     packages will teach caregivers how to apply strategies that aim to reduce the number of~     temper outbursts that the children show following changes, as well as making any outbursts~     they do show less severe (less functionally impairing).~   "
76371|NCT02567344|"~     This is a double-blind, crossover trial that will recruit a cohort of non-treatment seeking~     Cannabis use disordered participants. Participants will then undergo either active, or sham~     rTMS to the LDLPFC, and cue-induced craving, and risky decision making will be assessed.~   "
76372|NCT02567331|"~     This study will evaluate the efficacy, safety, and pharmacoeconomics of oral capecitabine in~     patients with metastatic colorectal cancer. The anticipated time on study treatment is 3-12~     months, and the target sample size is 28 individuals.~   "
76376|NCT02567279|"~     The drastic reduction of nutritional intake in anorexia nervosa(AN) alters many hormonal~     factors that regulate the activity of bone cells. This alteration of bone remodeling is~     characterized by increased bone resorption and decreased bone formation, leading to a marked~     reduction of bone mineral density, osteoporosis and an increased risk of fracture.~      To date, there is a paucity of studies and no consensus on the management of bone loss in~     patients with AN. The few previous studies were performed with small samples and using short~     follow-up periods.~      Denosumab is a fully human monoclonal antibody that binds with high specificity to human~     RANKL (6, 7), thereby reducing the number and activity of osteoclasts and therefore~     decreasing bone resorption that was found increased in patients AN.~      Denosumab may transiently protect bone whilst psychonutritional management will induce a~     weight restoration~   "
76377|NCT02567266|"~     Emotional disorders, including an array of anxiety and depressive syndromes, are the most~     common psychiatric disorders among adolescents, are highly comorbid, and severely impair the~     lives of youth and their families. Extant evidence-based therapies target only single~     disorders or symptom domains, are often not adopted by community mental health center (CMHC)~     clinicians, and have only modest effect sizes. To improve the clinical outcomes of these~     youth, the proposed study tests the effectiveness of two novel interventions (a~     transdiagnostic intervention, the Unified Protocol for the Treatment of Emotional Disorders~     in Adolescents, and a measurement and feedback system, the Youth Outcomes Questionnaires)~     relative to usual care in CMHCs.~   "
76378|NCT02567253|"~     The OvIP1 study is designed to examine how drug dose and perfusion temperature affect the~     pharmacokinetics and pharmacodynamics of cisplatin used as (hyperthermic) intraperitoneal~     chemoperfusion, as an adjunct to surgery, in women with stage III epithelial ovarian cancer.~   "
76379|NCT02567240|"~     The goal of this study is to determine whether harvesting islets using carbon monoxide~     (CO)-saturated mediums can protect islet cell from death after autologous islet~     transplantation in patients with chronic pancreatitis.~   "
76380|NCT02567227|"~     The investigators propose to conduct a single-blind randomized clinical trial to test the~     efficacy of a computerized cognitive remediation intervention program on improving locomotion~     in sedentary seniors, a group at an especially high risk for disability. The hypothesis is~     that executive functions will respond to the cognitive remediation program and in turn~     enhance locomotion.~   "
76381|NCT02567214|"~     The investigators will compare the reduction in Borg dyspnea score during the 3-min constant~     rate shuttle walking test after 3 weeks of indacaterol 110 µg/Glycopyrronium 50 µg (Ultibro®)~     versus Tiotropium 18 µg (Spiriva®) alone in patients with moderate to severe COPD.~   "
76382|NCT02567201|"~     Aim : To assess the ability of healthy subjects and patients with a severe motor disability~     to voluntary control their attention~      Material and Methods:~      Population: healthy subjects, patients with brain injury Electroencephalographic study to~     research attentional modulation during different kind of stimulation (visual, auditory,~     tactile)~      Sudy 1: passive recording.~      Study 2: active recording (instruction of attentional control given to the subject).~      Study 3: active recording with a feedback obtained after a processing of the brain activity.~   "
76383|NCT02567188|"~     An observational, longitudinal, multi-center, non-interventional study in participants with~     chronic kidney disease (CKD) stage 3-4, assessed by Modification of Diet in Renal Disease~     (MDRD) to collect data regarding safety and efficacy in participants with pre-dialysis~     situation who are treated with MIRCERA in normal clinical environment.~   "
76384|NCT02567175|"~     FDA currently allows patients 12 years of age and older with various gastrointestinal (GI)~     conditions to be treated with Domperidone through the Expanded Access to Investigational~     Drugs program. These conditions include gastroesophageal reflux disease with upper GI~     symptoms, gastroparesis, and chronic constipation. Patients must have failed standard~     therapies to be eligible to receive Domperidone. This program facilitates availability of~     investigational drugs, (such as Domperidone) to patients with serious diseases or conditions~     when there is no comparable or satisfactory alternative therapy to diagnose, monitor, or~     treat the patient's disease or condition.~   "
76385|NCT02567162|"~     The aim of this project is development of a comprehensive, prospective, multinational,~     multicenter, hospital-based, data repository for patients with intracerebral hemorrhage.~   "
76386|NCT02567149|"~     The primary objective is to determine whether intralesional cidofovir is effective at~     bringing about the total or near-total resolution of warts that have already proven~     recalcitrant to standard therapy.~      The secondary objective is to determine the tolerability of this new mode of administration~     of cidofovir in the pediatric population~   "
76387|NCT02567136|"~     The purpose of the study is to determine if we are able to find one or more biomarkers of~     Amyotrophic Lateral Sclerosis (ALS) and Primary Lateral Sclerosis (PLS) using magnetic~     resonance imaging (MRI) scans at different levels, 3 tesla (3T) and 7 tesla (7T). A biomarker~     is a measurable characteristic that can be used as an indicator of a particular disease~     state. Identifying biomarkers of a disease can lead to a better understanding of the disease~     as well as improved treatments. This study will enroll patients with ALS, PLS, and healthy~     controls.~   "
76388|NCT02567123|"~     The purpose of this study is to determine whether changing foot strike pattern from a~     rearfoot strike to a forefoot strike reduces chronic running-related knee pain. It is~     believed that switching foot strike pattern from a rearfoot strike to a forefoot strike~     pattern will reduce associated running-related patellofemoral knee pain.~   "
76389|NCT02567110|"~     The purpose of this study is to determine the impact of inflammation on central nervous~     system (CNS) glutamate, white matter pathology and alterations in behavior and cognition in~     middle-aged patients with major depression. Depression is associated with significant~     alterations in glutamate concentrations and white matter integrity, which has been associated~     with decreased antidepressant response, poor functional outcome, and cognitive impairment.~   "
76495|NCT02565732|"~     This is a safety and efficacy study of botulinum toxin type A in subjects with primary~     axillary hyperhidrosis.~   "
76565|NCT02564822|"~     The aim of this study is to investigate the motor and visual cortex excitability in response~     to visual stimulation of migraineurs with and without aura compared to healthy individuals.~     For this purpose, electrical cortical activity of migraineurs will be compared to healthy~     volunteers.~   "
76390|NCT02567097|"~     Tobacco use is the greatest cause of ill health and early mortality, and smoking is the main~     contributor to around 75,000 deaths a year in England. The aim of the present research is to~     test the effect of helping people to reward themselves when they have successfully abstained~     from smoking and the impact this will have on subsequent smoking cessation. Each participant~     will be randomly allocated to one of four conditions. The trial requires 159 participants to~     perform an fully powered statistical analysis. The four conditions include: (1) a control~     condition (asked to form a plan to quit smoking), (2) an implementation intention condition~     (asked to form a more specific 'if-then' plan), (3) baseline which include: (1) a control~     condition (asked to form a plan to quit smoking), (2) a volitional help sheet condition~     (asked to link temptations with appropriate behavioural responses), (3) a weekly~     self-incentivising condition (asked to reward themselves at the end of each week that they~     have successfully abstained from smoking), or (4) a monthly self-incentivising condition~     (asked to reward themselves at the end of each month that they have successfully abstained~     from smoking). The main outcome measure will be smoking quit status, which will be verified~     biochemically at the end of the stop smoking programme, and at six-months post quit date.~   "
76391|NCT02567084|"~     The purpose of this study is to assess the ability a injectable bi-phasic ceramic bone~     substitute to provide bone generation and bone remodeling in patients with benign bone~     tumors.~   "
76392|NCT02567071|"~     The proportion of cesarean deliveries reached 30% of births in the US in 2008, while in the~     1970s, it rarely reached 15%, as recommended by WHO. According to recent reports in some~     hospitals in China the use of cesarean section increased from 5% in the 1970s to over 60%.~     The use of C-section continues to grow in every countries of the world despite that current~     knowledge leads us to think that the vaginal birth, retained through millennia during~     mammalian evolution, guarantees the implementation of the best suited intestinal microbiota~     to build immunity and beneficial protective functions under the balanced mutual association~     between the host and its microbiota. Oral administration of a previously impregnated swab, by~     vaginal and maternal perineal secretions, following birth by planned C-section, would restore~     the normal development of the newborn intestinal microbiota mimicking exposure to these~     secretions during vaginal delivery.~      The expected benefit is the establishment of a rich and diverse microbiota in individuals in~     the intervention group and by extension improving the overall health of these individuals.~   "
76393|NCT02567058|"~     Among Musculoskeletal disorders (MSD) the rupture of the Achilles tendon is the most common.~     Up today, the mechanical and elastic properties of the Achilles tendon are still unknown, and~     that both in healthy subjects in pathology. The viscoelastic properties or dynamic mechanical~     properties are directly related to the tendon of the health status and its elongation~     capacity.~      The laboratory UMR Inserm U930 - CNRS ERL 3106 in Tours has developed a non-invasive~     ultrasonic device, named Achillus, which, via an ultrasonic probe, allowing to access the~     viscoelastic properties of the tendon during the contraction of the sural triceps.~      This is what we want to do in this first protocol: in vivo observation of the normal values~     and variations, looking for changes related to hyper solicitation and finally trying to~     highlight a tendon fragility parameter for patients who have experienced of a Achilles tendon~     rupture.~   "
76394|NCT02567045|"~     This is a multicenter, controlled, randomized phase III study to compare participation rate~     with two screening rounds of fecal occult blood test (FIT) versus one-time screening~     colonoscopy in first degree relatives (FDR) of patients diagnosed of colorectal cancer (CRC).~      The hypothesis of the study is that annual FIT uptake and colonoscopy when a positive test is~     higher than that of straightforward colonoscopy. Assuming an uptake of 0.50 for colonoscopy~     and 0.60 for FIT, a Type I error (alpha) of 5% and a power of 90%, 538 FDRs will be necessary~     to include in each group.~   "
76395|NCT02567032|"~     In this study, investigators will examine the behavioral effects and neurophysiological~     mechanisms of the pro-social neuropeptide oxytocin in patients with recent-onset~     schizophrenia. Such research is a necessary first step towards identifying whether intranasal~     oxytocin administration can serve as an adjunct treatment for social impairments in~     schizophrenia.~      Aim 1: To quantify the effects of exogenous oxytocin on social cognition and behavior in~     patients with recent-onset schizophrenia.~      Hypothesis A: Patients and healthy comparison subjects will show enhanced social cognition~     (e.g., improved interpretation of paralinguistic and emotional cues, such as those involved~     in emotional or sarcastic communication) after administration of oxytocin versus placebo.~      Hypothesis B: Patients and healthy comparison subjects will show increased attention to~     others' eyes and patients will exhibit increased facial affect expressivity after~     administration of oxytocin versus placebo.~      Aim 2: To examine the effects of exogenous oxytocin on PNS activity in patients with~     recent-onset schizophrenia.~      Hypothesis A: Patients and healthy comparison subjects will demonstrate increased PNS~     activity during social tasks after administration of oxytocin versus placebo.~      Hypothesis B (exploratory): Patients and healthy comparison subjects' improvements in social~     cognition and behavior will be predicted by the degree to which oxytocin increases their PNS~     activity.~   "
76396|NCT02567019|"~     Periodontal diseases are a group of diseases that affect 15% of the population and in the~     absence of treatment causes tooth loss. Periodontal lesions are characterized mainly by~     strong inflammation and hyper-vascularization. Search in blood cells and inflammatory markers~     attempts to explain the etiological-pathogenetic mechanisms. Innate immunity can be assessed~     by qualitative and quantitative analysis of blood phagocytes, natural killer cells,~     complement, proteins of inflammation and cytokines. Current data from the literature on this~     subject give contradictory results and the comparison of studies are difficult because the~     diversity of the populations studied, evaluated cells and the methods used. The aim of the~     study was to evaluate the innate immunity of patients with periodontal disease and compare it~     with a group of patients without periodontal disease.~   "
76397|NCT02567006|"~     This project plans to learn more about whether sending text messages to parents on their~     mobile phones to remind them when their child is due for his or her next vaccination will~     improve children getting vaccinated on time.~   "
76598|NCT02564380|"~     A Phase II Randomized, Double-Blind, Placebo-Controlled Study of Pembrolizumab Maintenance~     Following First-Line Platinum Based Chemotherapy in Patients with Metastatic Squamous -~     Non-Small Cell Lung Cancer (sNSCLC).~   "
76398|NCT02566993|"~     Phase III randomized clinical trial of lurbinectedin (PM01183)/doxorubicin (DOX) versus~     cyclophosphamide (CTX), doxorubicin (DOX) and vincristine (VCR) (CAV) or topotecan as~     treatment in patients with small-cell lung cancer (SCLC) who failed one prior~     platinum-containing line to determine a difference in progression-free survival (PFS) by an~     Independent Review Committee (IRC) between lurbinectedin (PM01183)/doxorubicin (DOX) and the~     control arm (CAV) or topotecan and to analyze the median overall survival (OS) and mid- and~     long-term overall survival (OS at 12, 18 and 24 months).~   "
76399|NCT02566980|"~     The goal of the study is to define and measure biological processes that contribute to the~     underlying pathophysiologic process of peri-partum depression to be used for identifying~     those at risk for developing it. This knowledge may also generate novel drug targets for~     peripartum depression that may be applicable to other types of depression.~   "
76400|NCT02566967|"~     This study will evaluate the optimal dose of tofacitinib needed to achieve low disease~     activity (LDA) or clinical remission as measured by the CDAI score. Once LDA or clinical~     remission has been achieved, the structural benefit in reducing erosions, synovitis and bone~     edema as measured by low field MRI will be determined at the same time period by the use of~     the OMERACT/RAMRIS scoring system~   "
76401|NCT02566954|"~     The study will be in 3 parts: first one will be to address the key question of the lower limb~     frontal alignment based on both three-dimensional measurements of low-dose bi-planar X-rays~     and foot morphology assessment. Indeed, a major issue in the management of lower limb~     disorders is the ability to correctly assess abnormal development and decide on the most~     adapted treatment option. In particular, the link between lower limb disorders and foot~     morphology remain unclear. Recently, quantitative 3D measurement of the lower limb in~     children has been successfully assessed using low-dose biplanar X-rays.~      Second part will be to assess the reproducibility of the 3dimensional reconstructions whether~     they are made by a radiology technician, or by a so-called expert through collecting datas~     from 3 centers of pediatric surgery where EOS Imaging system is daily used to get spine or~     lower limb X-Rays.~      Last part will be to work on the recently developed weight-bearing foot 3D reconstruction~     method for clinical use using the Parametric Personalized Modelling approach (PPM). This will~     allow having a better understanding and evaluation of foot's anatomy and patho-anatomy.~   "
76402|NCT02566941|"~     Neuromuscular stimulation (NMES) has been used for several years in the rehabilitation of~     COPD (chronic obstructive pulmonary disease) patients (among others) to improve their~     resistance to efforts in everyday life. In patients in intensive care, it seems to improve~     strength, reduce the loss of muscle mass, prevent the development of CIP / CIM (Critical~     illness polyneuropathy / critical illness myopathy) and perhaps even reduce ventilation days,~     with expected effects on the duration of hospitalization and the long-term functional~     outcome. Although its use could sometimes be limited by the development of peripheral edema~     and use of vasoconstrictors, the main advantage of this technique is the possibility of being~     used very early, even in patients that require deep sedation . This is extremely important~     given that the muscular atrophy process already starts 18h after the onset of invasive~     ventilation and as signs of impaired nerve transmission are developed in one third of~     patients at risk within 72 hours.~      The purpose of the study is to assess the effects, in the short and medium term, of early~     neuromuscular stimulation in patients who are at higher risk of developing a critical illness~     polyneuropathy (CIP) / critical illness myopathy (CIM) spectrum disease.~      This is a randomized controlled single-blind study comparing a group of patients submitted to~     NMES early (up to 5 days after admission) versus a control group unstimulated.~   "
76403|NCT02566928|"~     The overall goal of the project is to develop and evaluate a home-based intervention to~     prevent re-infection and transmission of Community-Acquired Methicillin-resistant~     Staphylococcus aureus (CA-MRSA) in patients presenting to primary care with skin or soft~     tissue infections (SSTIs). Centers for Disease Control (CDC) CA-MRSA guidelines include~     incision and drainage, antibiotic sensitivity testing and antibiogram-directed prescribing.~     Re-infections are common, ranging from 16% to 43%, and present significant challenges to~     clinicians, patients and their families. Several decolonization and decontamination~     interventions have been shown to reduce Hospital-Acquired MRSA (HA-MRSA) re-infection and~     transmission in intensive care units. Few studies examine the feasibility and effectiveness~     of these infection prevention interventions into primary care settings, and none employ~     Community Health Workers (CHWs) or promotoras to provide home visits for education and~     interventions about decolonization and decontamination. This comparative effectiveness~     research/patient centered outcomes research builds upon a highly stakeholder-engaged~     community-academic research and learning collaborative, including practicing clinicians,~     patients, clinical and laboratory researchers, and barbers/beauticians. Clinical Directors~     Network (CDN), an established, NIH-recognized best practice Federally Qualified Health Center~     (FQHC) Practice-based Research Network (PBRN), and The Rockefeller University propose to~     address this question through the completion of four aims: (1) To evaluate the comparative~     effectiveness of a CHW/Promotora-delivered home intervention (Experimental Group) as compared~     to Usual Care (Control Group) on the primary patient-centered and clinical outcome (SSTI~     recurrence rates) and secondary patient-centered and clinical outcomes (pain, depression,~     quality of life, care satisfaction) using a two-arm randomized controlled trial (RCT). (2) To~     understand the patient-level factors (CA-MRSA infection prevention knowledge, self-efficacy,~     decision-making autonomy, prevention behaviors/adherence) and environmental-level factors~     (household surface contamination, household member colonization, transmission to household~     members) that are associated with differences in SSTI recurrence rates. (3) To understand~     interactions of the intervention with bacterial genotypic and phenotypic variables on~     decontamination, decolonization, SSTI recurrence, and household transmission. (4) To explore~     the evolution of stakeholder engagement and interactions among patients and other community~     stakeholders with practicing community-based clinicians and academic laboratory and clinical~     investigators over the duration of the study period.~   "
76404|NCT02566915|"~     The purpose of this study is to evaluate the effects of the application of Expiratory~     Positive Airway Pressure (EPAP) on Dynamic Hyperinflation, dyspnea and exercise tolerance in~     patients with Chronic Obstructive Pulmonary Disease (COPD).~   "
76405|NCT02566902|"~     This is a blinded observer randomized controlled trial comparing two nebulizer devices. The~     objective of this study is to evaluate the efficacy of two different nebulizers.~   "
76406|NCT02566889|"~     The purpose of this study is to evaluate whether trough serum infliximab concentrations at~     the time of loss of clinical response will identify pediatric participants with inflammatory~     bowel disease (IBD) who would benefit (regain clinical response) from dose escalation above~     the currently approved dose [5 milligram (mg)/kilogram (kg) every 8 weeks (q8wk)] and the~     safety of that dose escalation.~   "
76550|NCT02565017|"~     The purpose of this study is to learn what cancer patients think about IBM Watson Oncology.~     IBM Watson Oncology is a computer program designed to help inform oncologists about the best~     chemotherapy choices for their patients. The investigators will conduct focus groups with~     cancer patients who have received chemotherapy treatment at MSK in order to understand cancer~     patients' thoughts about IBM Watson Oncology.~   "
76407|NCT02566876|"~     Abdominal pain (AP)-associated functional gastrointestinal disorders (FGIDs), particularly~     Irritable Bowel Syndrome (IBS) and Functional Dyspepsia (FD), are common in pediatrics, and~     no safe and effective treatment is available. Although probiotics have shown promising~     results in adults, few studies have been published in children. The Bifidobacterium Infantis,~     Bifidobacterium Breve and Bifidobacterium Longum are the most important beneficial bacteria~     in children and represent 95% of the total bacterial population in the intestine of breastfed~     infant.~      Objectives: 1) To evaluate the effect of oral administration of a mixture of Bifidobacteria~     on the improvement of frequency and intensity of AP in children with FD and IBS. 2) To~     evaluate the effect of oral administration of a mixture of Bifidobacteria on quality of life~     in children with FD and IBS.~   "
76408|NCT02566863|"~     Dexmedetomidine, selective alfa2 receptors agonist produces sympatholysis. As a result heart~     rate decreases. With low doses blood pressure also decreases, with higher dosing - systematic~     vascular resistance increases. The indication for the drug is to produce sedation during~     surgical procedures and in ICU patients.~      The aim of a study is to verify, whether the haemodynamic effect (heart rate, blood pressure~     and heart rate variability during drug infusion) depend on pre-drug autonomic system~     activity. Autonomic system activity is assessed using heart rate variability (HRV)measurement~     before drug injection and during drug infusion. Heart rate and blood pressure measured before~     and during drug infusion will be analysed.~      HRV measurement analysis will be based on continuous Holter ECG recording, taken before drug~     injection and during its infusion. 5 minutes intervals will be analysed , using Frequency~     Domain Measures of HRV. Surgical procedure will start after measurement have been taken.~   "
76409|NCT02566850|"~     The purpose of the study is to study the safety and health effects of using the Ekso Bionics~     powered exoskeleton device in a home setting over a 12-36 month period.~   "
76410|NCT02566837|"~     Intramuscular injections of botulinum toxin are currently the best focal treatment of~     spasticity, with clearly defined indications and role. French and European recommendations~     focus on the toxin's mode of administration, which must be as precise as possible. The~     toxin's specific action on motor endplates (blocking the release of acetylcholine) shows the~     importance of targeted injections within the muscle belly. The pain caused by these~     injections is due partly the number of injections (up to 30 in a single session), and partly~     to the use of electrical stimulation guidance. Prevention and alleviation of the pain caused~     by these injections have become a regulatory obligation since the law of 4 March 2002~     relating to the rights of patients and the quality of the health system ( Any person has the~     right to receive relief from pain, which must, under all circumstances, be prevented,~     evaluated, taken into account and treated … ).~   "
76411|NCT02566824|"~     Attention Deficit/ Hyperactivity Disorder (ADHD) is a common childhood psychiatric condition,~     which often persists into adolescence. In adolescence ADHD is associated with poor academic,~     social, and emotional functioning, other psychiatric problems, substance abuse, and~     antisocial behaviour. Although medication effectively reduces symptoms such as hyperactivity~     and inattention, it does not directly address academic, social, emotional, and behavioural~     problems. Overcoming these would require building skills in organization, time management,~     problem solving, emotional modulation, stress management and interpersonal rapport. Yet,~     psychosocial treatments targeting such skills in adolescents with ADHD have been little~     studied and are scarce in the community. The proposed study will evaluate cognitive~     behavioural and skills training therapy (CBT+S) for adolescents with ADHD. Adolescents will~     decide whether they want to take medication to treat their ADHD symptoms. If they choose to~     be on medication, they will be stabilized on optimized medication and randomly assigned to 12~     sessions of either manualized group cognitive behavioral and skills training therapy (CBT+S)~     or manualized supportive group therapy (SGT). An additional treatment-as-usual group will~     also be included. CBT+S will focus on skill acquisition in common problem areas for~     adolescents with ADHD, such as organization and time management, distractibility,~     impulsivity, and social skills. A coach will call each participant twice a week to help~     practice the learned skills.~      Parallel groups will be provided for parents of CBT+S and SGT participants focusing on~     education, support and sharing experiences. If CBT+S proves to benefit adolescents with ADHD,~     it can be made widely available to these adolescents in the community. This would help them~     improve their academic, social, and emotional functioning and ultimately their long term~     outcomes.~   "
76412|NCT02566811|"~     The primary aim of this trial is to determine whether lymphadenectomy, used to restrict~     adjuvant therapy (other than vaginal brachytherapy) to node positive women, results in a~     non-inferior survival as compared to adjuvant therapy given to all women with high risk~     apparent stage 1 endometrial cancer.~   "
76413|NCT02566798|"~     Osteoarthritis is a degenerative disease that affects a growing proportion of the population.~     There is currently no treatment to halt this process. The aim of the research is in~     particular to find treatments targeting the molecular origins of osteoarthritis focusing~     especially on the inflammatory component of the disease. That is why research is looking to~     the development of preventive treatments like nutraceuticals. This project aims to determine~     the anti-inflammatory properties of sera of patients who received supplementation of their~     diet with an extract of grape and olive: the Oléogrape®SEED. Sera and synovial fluid will be~     collected during visits for hyaluronic acid injections in OA patients. These sera will be~     tested in vitro in a model of inflamed chondrocytes.~   "
76414|NCT02566785|"~     Purpose: The purpose of this pilot study is to evaluate the effect of a multi-component~     balance & resistance training [RT] intervention on physical function, balance, & falls in~     older [≥ 65 y/o] community dwelling heart failure [HF] patients. The study aims: 1] Pilot~     test multi-component balance activities & RT intervention on primary outcomes. 2] Explore~     perceptions related to outcomes & the intervention through focus groups. 3] Generate pilot~     data on adherence. 4] Generate pilot data on feasibility of conducting the BASIC Training~     intervention.~      Background/Significance: Falls are the leading cause of injury-related deaths in this group.~     Fall risks are even greater for those with HF due to decreased exercise capacity, loss of~     skeletal muscle & medication side effects. Though RT is effective for improving skeletal~     muscle, it has only a modest effect on improving balance, which is comprised of peripheral~     sensory input central integration, & motor output. A multi-component intervention focusing on~     balance retraining & strengthening the muscles supporting static/dynamic balance & functional~     mobility is necessary.~      Methods: Design - Randomized, two-group with wait list control, repeated measures~     experimental design. Sample/ Setting - 40-50 participants recruited from medical center heart~     failure clinic; supervised group sessions conducted in center's health & wellness center.~     Procedures - Participants will be randomized to intervention group or wait list control~     group. Focus groups pre/post intervention. The intervention will be administered in 1x per~     week supervised group sessions & 2x a week home sessions. Instruments - 30 Second Sit-to-St&,~     Modified Clinical Test of Sensory Interaction on Balance, Activity Specific Balance~     Confidence Scale, Timed Up & Go, Dynamic Gait Index.~      Analysis Plan: Aim 1- independent t-test to compare change scores from baseline to the end of~     the first 12 week period for the intervention group with the wait list control group. A~     second analysis will combine data from the delayed intervention period for the wait list~     control group with that from the first 12 week period for the intervention group to test~     change. Supplemental analysis, involving only data from intervention group, will test whether~     change is sustained at 24 weeks. Aim 2 - thematic analysis conducted with focus group data.~     Aim 3 - adherence assessed by group session attendance & home activities completed. Aim 4 -~     assess & report logistics of conducting the study.~      Nursing Relevance/Implications: This pilot study will initiate the process of developing a~     targeted intervention to induce changes in elderly HF patients to prevent future falls; thus~     reducing costs, physical & emotional burdens related to falls; & effect a major difference in~     the quality of life for this population.~   "
76417|NCT02566746|"~     The investigators' study aims to compare the results of percutaneous endoscopic caecostomie~     (CPE) to optimal medical therapy in the treatment of patients with constipation refractory to~     medical treatment. The primary endpoint will be the quality of life assessed by the~     Gastrointestinal Quality Of Life Index (GIQLI) at one year. The secondary endpoints are~     digestive symptoms, Kess's constipation scores and Cleveland's incontinence score, tolerance~     of the Chait TrapdoorTM caecostomy catheter (CTCC) and the collection of possible~     complications. The patients included must meet the classification criteria of Rome III, have~     an elongated colonic transit time, have had a complete colonoscopy and be refractory to~     medical treatment including at least one stimulant laxative or suppositories or enemas~     retrograde.~   "
76418|NCT02566733|"~     Target controlled infusion with remifentanil is widely used during cardiac surgery, wich is~     performed using the Minto model. It was derived from patients undergoing general surgery.~     However, pharmacokinetics of remifentanil can be changed during cardiopulmonary bypass. The~     investigators tested whether Minto model for target controlled infusion produces constant~     plasma remifentanil concentration during the cardiac surgery.~   "
76419|NCT02566720|"~     This is a pilot study. The objective is to further understand the mechanism by which~     amantadine improves function in patients with persistent vegetative state and minimally~     conscious state. Specifically, the investigators will measure the size of the nerve fibers~     that mediate arousal (reticular activating system, or RAS) pre and post treatment on MRI~     tractography. MRI findings will be correlated with the Disability Rating Scale (DRS) score.~     The information gathered from this study will be used to formulate a larger clinical trial.~   "
76420|NCT02566707|"~     During the past years the treatment of HIV-1 infection has transformed towards chronic~     treatment. Patients are being treated with antiretroviral drugs for many years and become~     older. The risk of developing side-effects due to long term antiretroviral therapy is~     therefore more and more likely. New alternative once-daily maintenance regimes are needed for~     those who are extensively pre-treated and experience side-effects or toxicity on standard~     treatment combinations. A possible once-daily, fully active maintenance regimen is the~     combination of atazanavir (unboosted), dolutegravir and lamivudine (PRADAII regimen). This~     combination is expected to be a safe, once-daily maintenance regimen with a favorable~     side-effect profile. The combination suits patients with intolerance and/or resistance to~     NRTIs, NNRTIs and ritonavir, who have a suppressed viral load. However, for this new~     combination the pharmacokinetic profile is unknown and there are no data on short-term and~     long-term safety and efficacy. This study wille therefore asses the pharmacokinetics, safety~     and efficacy in a small number of HIV-1 infected patients.~   "
76421|NCT02566694|"~     The investigators aim to determine the cause of failure of orthopaedic implants using~     multi-disciplinary analysis of data from patients who have undergone revision.~   "
76422|NCT02566681|"~     The purpose of this study is to evaluate the safety of use of autologous bone marrow stem~     cells seeded on porous tricalcium phosphate matrix and demineralized bone matrix in patients~     with osteonecrosis of the jaw by a prospective, single-center, open, nonrandomized and~     unblinded clinical trial.~   "
76423|NCT02566668|"~     This research study is being done to learn more about severe asthma by comparing people with~     severe asthma to those with milder forms of asthma and people without asthma, at baseline and~     over time. Individuals are being asked to join a research study to help understand the~     differences in the lungs and blood of participants with severe asthma compared to those with~     milder asthma and healthy individuals, as well as differences in overall health.~     Investigators also want to determine whether these differences predict asthma-related and~     biologic outcomes over 1 year of follow up.~   "
76424|NCT02566655|"~     The purpose of this study is to evaluate the safety of intravenous infusion of fucosylated~     autologous bone marrow cells as a new therapy in patients with established osteoporosis by a~     prospective, single-center, open, non-randomized and unblinded clinical trial.~   "
76425|NCT02566642|"~     When presenting for elective surgery, patient's often do not completely understand the role~     that the anesthesiology team plays in their care. In 1999, the American Medical Association~     (AMA) found that health literacy was a stronger predictor of a person's health than age,~     income, education level and race. It is very important that the investigators provide~     information to patients on the role of anesthesiologists in their care before, during, and~     after the surgery as it has been shown to improve patient anxiety and overall satisfaction.~   "
76426|NCT02566629|"~     Analyze microbiota community of irritable bowel syndrome in episodes phase and remission~     phase.~   "
76427|NCT02566616|"~     Cubital tunnel syndrome is caused by compression of the ulnar nerve at the elbow. This leads~     to symptoms such as chronic hand weakness, numbness and pain. This is usually treated with a~     surgical procedure where the nerve is decompressed. Research has shown that nerve simulators~     speed up the recovery of nerves following injury. The purpose of our research is to examine~     the difference in patient outcomes after the nerve decompression surgery with and without~     nerve stimulation.~      Our research questions is: What are the differences in long term functional outcomes of~     patients that have ulnar nerve decompression surgery with and without nerve stimulation?~   "
76428|NCT02566603|"~     Pre-clinical and clinical evaluations show that PRTX- 100 has biological activity that may~     lead to improved platelet levels where these are decreased due to immunological pathologies~     and that PRTX-100 has an acceptable safety profile. In vivo treatment with PRTX-100 has been~     shown to raise platelet counts in a mouse model of immune thrombocytopenia (ITP). The primary~     objective of the study is to assess the efficacy of PRTX-100 in terms of platelet response in~     patients with chronic/persistent ITP.~   "
76451|NCT02566304|"~     This clinical trial studies the use of reduced intensity chemotherapy and radiation therapy~     before donor stem cell transplant in treating patients with hematologic malignancies. Giving~     low doses of chemotherapy, such as cyclophosphamide and fludarabine phosphate, before a donor~     stem cell transplant may help stop the growth of cancer cells. It may also stop the patient's~     immune system from rejecting the donor's stem cells. The donated stem cells may replace the~     patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor~     effect). Reducing the intensity of the chemotherapy and radiation may also reduce the side~     effects of the donor stem cell transplant.~   "
76452|NCT02566291|"~     In a observational study the second-generation laryngeal masks LMA Supreme and Ambu AuraGain~     are investigated.~   "
76429|NCT02566590|"~     One third of independent older adults over the age of 65y will be hospitalized for an acute~     medical illness, injury, or operative procedure. Unfortunately, 50% of these older adults~     will experience functional decline during their hospital stay from the amount of time they~     are physically inactive and in bed. Following discharge, the functional deficits can persist~     for months and in many instances never return to pre-hospitalization levels thus compounding~     morbidity, health care costs and dying. A classic consequence of short-term bed rest in older~     adults is the significant loss in skeletal muscle mass which underlies the accelerated leg~     strength deficits. The investigator has shown that an important mechanism of skeletal muscle~     loss is the inability of nutrients to stimulate a normal muscle protein synthesis response; a~     process highly regulated by the mammalian target of rapamycin signaling pathway (mTOR) and~     amino acid transporters. Day to day maintenance of force generating muscle tissue is dictated~     by anabolic stimulation from muscle contraction and essential amino acid ingestion.~     Therefore, anabolic interventions such as neuromuscular electrical stimulation (NMES) and~     high quality protein supplementation that contains a high proportion of essential amino acids~     (whey protein) may be promising approach to maintain leg muscle mass and strength in~     hospitalized older adults and prevent the long term consequences of repeated periods of~     short-term physical inactivity. The purpose of this study is to test in older adults if the~     combination of NMES and protein supplementation is capable of preserving muscle mass and~     strength and maintaining muscle nutrient anabolic sensitivity during bed rest. The~     investigators current hypotheses are that daily NMES and protein supplementation during~     5-days of bed rest in older adults will: 1) preserve lower extremity muscle mass and strength~     and 2) maintain muscle nutrient anabolic sensitivity as measured by mTOR signaling and amino~     acid transporter expression. The long term goal is to utilize this inpatient preventative~     therapeutic approach in a clinical setting in which muscle mass and strength deficits are~     profound (e.g., intensive care patients).~   "
76430|NCT02566577|"~     The purpose of this study is to determine how red blood cell transfusions, particularly the~     length of storage time of units of packed red blood cells, affects the cardiovascular~     function in patients receiving transfusions. This study will also determine the most ideal~     way of storing and processing blood, and assess how transfusion affects a person's ability to~     exercise and how their blood vessels relax and contract.~   "
76431|NCT02566564|"~     Phase I/IIa study to determine the safety and clinical effects of intra-articular injections~     of MTX-071 (Lopain) in patients with chronic osteoarthritic knee-joint pain.~   "
76432|NCT02566551|"~     The purpose of this prospective randomized controlled study is to compare the improvement of~     symptoms from benign prostatic hyperplasia (BPH) and the improvement of QoL, in patients~     undergoing prostatic artery embolization (PAE) or conventional transurethral resection of the~     prostate (TURP).~   "
76433|NCT02566538|"~     Aging is a long term process, starting early in life, and progressively affecting various~     functions and organs. Cardiovascular diseases and cognitive impairment are two conditions~     related to advancing age and sharing common risk factors. The Mona Lisa- PREDOR study is a~     population-based prospective cohort study carried out to develop risk prediction algorithms~     aimed at identifying people who are the most likely to develop impaired psychometric and~     cognitive functioning and impaired cardiovascular risk, in the coming years.~   "
76434|NCT02566525|"~     Prospective, multi-center, randomized, feasibility clinical study. Subjects will be~     randomized in a 1:1 ratio to either standard of care (SOC) alone or standard of care and~     treatment with the CytoSorb® device.~   "
76435|NCT02566512|"~     The investigators propose to assess cough strength in patients undergoing spontaneous~     breathing trials in the Intermediate Intensive Care Unit (IICU) and compare their cough~     strength under two conditions,~        1. Tracheostomy cuff inflated: cough strength will be measured with the tracheostomy cuff~          inflated and the patient coughing through the tracheostomy tube.~        2. Tracheostomy cuff deflated: cough strength will be measured with the tracheostomy cuff~          deflated and the patient coughing around the tracheostomy tube, through their mouth..~      The investigators hypothesize that patients will have a stronger cough when they can use~     their vocal cords.~   "
76436|NCT02566499|"~     The main goal of this project is to assess the ability of a recently developed Breast~     Microwave Imaging (BMI) system to detect abnormalities in a human breast. These trials will~     be performed by recruiting fourteen volunteers that have been diagnosed with breast~     abnormalities using x-ray mammography. The breast presenting the abnormality will be imaged~     using the BMI system in a controlled and comfortable environment. As this is a feasibility~     study of the technology, and has the main goal to evaluate the diagnostic accuracy of this~     technology. The data collected from this study will be used to: (1) evaluate the overall~     participant experience during the BMI imaging procedure, (2) optimize the design of the BMI~     imaging system (both hardware and software), (3) open discussions with other medical~     professionals (e.g. radiologists) about the clinical feasibility of this emerging diagnostic~     imaging modality.~   "
76437|NCT02566486|"~     Aim The aim of this clinical study was to evaluate the influence of the instrumentation~     techniques on the incidence and intensity of postoperative pain in single-visit root canal~     treatment.~      Methodology Ninety patients with single root/canal and non-vital pulps were included. The~     patients were assigned into 3 groups according to root canal instrumentation technique used;~     the modified step-back (stainless-steel hand files, HF), reciprocal (WaveOne, WO), and~     rotational (ProTaper Next, PTN). Root canal treatment was carried out in a single visit and~     the severity of postoperative pain was assessed by 4-point pain intensity scale. All the~     participants were called through phone at 12, 24 and 48 h to obtain the pain scores. Data~     were analyzed by the Kruskal-Wallis test.~   "
76438|NCT02566473|"~     Aim 1. Establish a national registry of diverse patients of orthopedic surgeons representing~     all regions of the country and varied hospital and surgeon practice settings (e.g.,~     urban/rural, low and high volume) to ensure that registry analyses and research reflect~     typical clinical practice thereby providing optimal guidance for patients, clinicians, and~     national healthcare policymakers. Collect pre-operative and post-operative patient reported~     outcomes (PROs) for pain and function.~      Aim 2: Develop new and transformative comparative effectiveness tools useful to both clinical~     practice and healthcare policy.~      Aim 3. Broadly disseminate surveillance reports for adverse events, such as implant revision,~     hip dislocation, knee manipulation, and identify important variation to inform quality~     improvement priorities.~   "
76490|NCT02565797|"~     Henry Ford Health System will evaluate the DabirAIR overlay system (DOS) for its~     effectiveness in preventing hospital acquired pressure ulcer (HAPU) in the peri-operative~     setting. The primary objective of the study is to compare the prevention-effectiveness~     (incidence rate of HAPU) between DOS (treatment group) vs facility specific standard of care~     pressure-relieving device(s) (control group) peri-operatively to discharge.~   "
76491|NCT02565784|"~     The purpose of this study is to evaluate the safety and efficacy of Restylane Lidocaine and~     Restylane Perlane Lidocaine after the first and second treatment when used for facial~     augmentation in Asian population.~   "
76439|NCT02566460|"~     The purpose of this study is to explore and assess possible outcome benefits of lactate~     clearance＞30% vs ScvO2 ≥70% in 6 hours as the protocol goal that evaluated adequacy of during~     early resuscitation of septic shock through a single-center randomized controlled study. The~     investigators anticipate to collect 300-400 qualified patients with septic shock who were~     selected from critically ill patients admitted to the Department of Critical Care Medicine.~     The participants can be randomized divided into lactate clearance group and SCVO2 group. The~     investigators compared the treatment and the relevant parameters changed after different~     target. 28-day mortality, ICU and hospital lengths of stay, ventilator-free days, and new~     emerged organ failure were collected and compared. 28-day survival curves were drew between~     these two group. And the adverse events of the treatment have also been compared. Through~     this study, the investigators want to answer that whether lactate clearance-oriented therapy~     can reduce the mortality in patients with septic shock, compared with ScvO2-oriented~     protocolised therapy.~   "
76440|NCT02566447|"~     The Solana® Trichomonas Assay is an in vitro qualitative nucleic acid amplification test for~     the detection of Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the~     Helicase-Dependent Amplification (HDA) technology and the Solana instrument.~   "
76441|NCT02566434|"~     Participants will receive four different doses of methionine through four month long~     interventions with a two week wash-out period in between intervention. The dose will increase~     with each intervention. Two visits during each intervention will also involve receiving~     stable isotope infusion to determine the metabolism of methionine in the body. Participants~     will also be monitored via blood work and questionnaires regarding overall health.~   "
76442|NCT02566421|"~     This pilot clinical trial studies patients' genomic sequencing in determining specific~     treatments, also called Precision Medicine, in patients with cancer that has spread to other~     parts of the body (metastatic) and/or cannot be removed by surgery. Examining the genetic~     code of a patient's tumor, a mutation (a change in the deoxyribonucleic acid [DNA] sequence~     of a cell or gene) may be identified and matched with available treatment that targets the~     mutated gene or an alternative treatment that may provide benefit for the patient with the~     mutation identified. Precision medicine may impacts patient's response to treatment by~     targeting specific mutations and may increase survival and improve quality of life.~   "
76443|NCT02566408|"~     This clinical trial studies the attitudes, beliefs, and preferences of older stage I-III~     breast cancer survivors towards physical activity. Studies have shown that older~     African-American and women of lower socioeconomic status are more likely than their Caucasian~     counterparts and women of higher socioeconomic status to have functional disability at the~     time of a new breast cancer diagnosis. Functional disability is the inability to~     independently complete activities of daily living and increases health care costs and deaths.~     The poor health status of older African-Americans with breast cancer has been suggested to~     diminish the long-term benefits from cancer treatment, resulting in older African-American~     women more likely to die from breast cancer compared to Caucasians. Questionnaires that~     measure the attitudes, beliefs, and preferences of older breast cancer survivors may lead to~     the development of an intervention that increases physical activity, improves functional and~     health status, and improves breast cancer treatment benefits translating to improved survival~     among older breast cancer survivors in general, and in particular among older~     African-American and lower socioeconomic status women with breast cancer.~   "
76444|NCT02566395|"~     This clinical pilot trial is intended to evaluate the feasibility, efficacy and safety of~     hematopoietic stem cell transplantation (HSCT) from Human Leukocyte Antigen (HLA)-mismatched~     related donors for children and young adults with hematologic malignancies who lack a~     suitably matched related or unrelated donor. The methodology will be one that has been~     successfully utilized in adult patients at Thomas Jefferson University.~   "
76445|NCT02566382|"~     Arthrodesis shoulder blade/humerus under arthroscopy. Implementation of an external fixative~     spray at the proximal level in the thorn of the scapula and distal in the diaphysis humerus.~   "
76446|NCT02566369|"~     Assessment of the efficacy and safety of CD5789 50μg/g cream applied once daily for 12 weeks~     in subjects with acne vulgaris.~   "
76447|NCT02566356|"~     In this study, investigators will examine the behavioral effects and neurophysiological~     mechanisms of the pro-social neuropeptide oxytocin in patients with recent-onset~     schizophrenia. Such research is a necessary first step towards identifying whether intranasal~     oxytocin administration can serve as an adjunct treatment for social impairments in~     schizophrenia.~      Aim 1: To examine the effects of exogenous oxytocin on patterns of neural activation as~     measured by fMRI during a well-characterized affect-labeling task in patients with~     recent-onset schizophrenia and healthy comparison subjects.~      Hypothesis A: Patients will exhibit amygdalar hyperactivity and PNS hypo-activity when~     passively viewing faces, which will be normalized by administration of oxytocin.~      Hypothesis B: Patients will exhibit hypo-activity of the vPFC when affectively labeling faces~     and this hypo-activity will be normalized by oxytocin administration.~   "
76448|NCT02566343|"~     This prospective study intends to investigate the incidence of postoperative pulmonary~     complications (PPC) or in-hospital mortality in patients with COPD or at risk for COPD~     undergoing high-risk noncardiac major surgery and to identify relevant risk factors.~     Furthermore, this study aims to quantify and compare the diagnostic performance of~     preoperative functional tests, exercise capacity, clinical assessment tests and predictive~     scoring systems to predict PPC or in-hospital mortality in these patients.~   "
76449|NCT02566330|"~     The aim in the current proposal is to evaluate the long-term outcome of the EndoBarrier~     device. The group of participants the investigators want to study participated in earlier~     studies at the Maastricht University Medical Center (MUMC) and the Atrium Medical Center in~     Heerlen. Three years of follow-up after the EndoBarrier device is now available. The~     investigators hope to give new insights in the postoperative status and postoperative~     symptoms experienced by the study participants using standardised questionnaires and~     evaluating blood samples. The goal of the investigators is to study the long-term effect of~     the EndoBarrier procedure and to possibly provide insight in the relation between~     success/failure and objective parameters.~   "
76450|NCT02566317|"~     A trial testing the efficacy of sit-stand workstations on decreasing sitting time and~     increasing light-intensity physical activity in samples of office worksites.~   "
76453|NCT02566278|"~     The investigators hypothesis is that upper airway collapsibility (Pcrit) in patients with~     obstructive sleep apnea (OSA) can be measured using equipment found in the clinical sleep~     laboratory and these Pcrit measurements obtained using clinical sleep laboratory equipment is~     comparable to those obtained using research equipment. OSA is a common disease characterized~     by repetitive collapse of the upper airway during sleep, leading to hypoxemia and arousals,~     and which has important neurocognitive and cardiovascular consequences. The single most~     important factor in the development of OSA is upper airway collapsibility: those with a more~     collapsible upper airway tend to have OSA while those with a stiffer upper airway do not. The~     gold standard treatment for OSA is continuous positive airway pressure (CPAP), which acts by~     stenting open the collapsible airway. Upper airway collapsibility can be measured during~     sleep by changing the CPAP level and assessing the change in inspiratory flow through the~     upper airway. Although technically feasible, these measurements are typically only undertaken~     in research laboratories with specialized equipment. The purpose of this study is to measure~     upper airway collapsibility using clinically available (i.e. equipment found in a clinical~     sleep laboratory) equipment only. If successful, upper airway collapsibility could be~     routinely measured in clinical practice, which could help inform treatment decisions and help~     individualize therapy for OSA.~   "
76454|NCT02566265|"~     The investigators' hypothesis is that the administration of Fluzone® High-Dose with booster~     to all patients with monoclonal gammopathies (irrespective of age) will lead to~     seroconversion rates exceeding 50% and more importantly, will reduce influenza-related~     morbidity, reduce interruptions in cancer therapy and may reduce disease progression at the~     end of the flu season~   "
76455|NCT02566252|"~     This study evaluates the effect of pre-treatment with either cromolyn sodium or albuterol~     sulfate on the safety and tolerability or PUL-042 Inhalation Solution in healthy subjects.~   "
76456|NCT02566239|"~     The purpose of this study is to learn more about how to maintain health and independence for~     seniors by developing tools that collect data constantly from their home. Caregivers can then~     use this information to make decisions about their health care, such as when an individual~     may not be able to live independently any longer. Specific Aims of this study are:~        -  Aim 1: To identify trends in our data that predict health decline. To serve this aim, we~          want to test a number of tools that we have developed, such as in-home sensors, to~          determine which ones are best at measuring health risks in seniors. After collecting~          information for one year, we will look at which tools could be most useful to provide~          feedback to seniors and their communities about the process of aging.~        -  Aim 2: To develop a system for analyzing the data we collect and presenting a summary of~          the data to care teams.~        -  Aim 3: To validate our data and the computer-based tool in senior community settings.~   "
76457|NCT02566226|"~     Intrathecal morphine is commonly used as an analgesic adjunct for hip arthroplasty performed~     under spinal anaesthesia. Sleep apnea syndrome is a condition that affects up to 10% of the~     patients. Effect of intrathecal hydrophilic opioids on the frequency and duration of apneic~     episodes is unknown. The objective of this randomised controlled trial is to investigate the~     effect of intrathecal morphine and surgery on apneic episodes.~   "
76458|NCT02566213|"~     The human performance during weightlessness was tested in a multiplicity of laboratory~     experiments during parabolic flights and in space. It is therefore known that human fine~     motor skills as grasping are affected by the impact of changing gravity levels. However,~     because everyday life movements differ in several aspects from those done in an experimental~     lab situation, investigators do not know until know if this kind of movements is altered in~     the same extend.~      Fine motor skills seem to depend on the context in which they are made. Thus, the performance~     in weightlessness during everyday life could substantially differ from the results given by~     previous laboratory studies.~      This assumption will be tested in the present project, with subjects executing one and the~     same grasping movement in two different contexts, both in normal gravity conditions and in~     weightlessness. To that end, the investigators developed a new method which allows comparing~     the same grasping movements under different conditions.~   "
76459|NCT02566200|"~     Over the last two decades, considerable progress has been made in the management of~     myocardial infarction, both in the acute phase and in monitoring beyond the hospital phase.~     However changing practices in the real world and their impact on prognosis in the medium~     and long term patients admitted to the intensive care unit for acute myocardial infarction~     are relatively little studied exhaustively.~      The study of clinical, biological and genetic characteristics of patients and their~     conditions of care, help to identify patients at risk for increased morbidity and mortality~     after myocardial infarction and could be the basis for the subsequent realization of specific~     studies on the optimal therapeutic management of the disease according to the different risk~     profiles.~   "
76460|NCT02566187|"~     A phase I, Open-label, Randomized, Single-dose, 2 x 2 Crossover Study to Compare the~     Pharmacokinetics of Fimasartan/Atorvastatin Combination Tablet and Coadministration of~     Fimasartan and Atorvastatin as Individual Tablets in Healthy Male Volunteers.~   "
76461|NCT02566174|"~     Background:~      Cancer causes changes in the lives of patients and in the lives of their caregivers. Patients~     and caregivers feel stress and they affect each other as they deal with these changes. They~     each cope with cancer diagnosis and treatment on their own. They also cope together.~     Researchers want to explore this shared change of roles and responsibilities. They will do~     this by gaining insight into the social experience of cancer caregiving. They also want to~     better understand the ways caregiver/patient teams manage the cancer diagnosis and~     experience. This can help find new ways to support caregivers and their patients.~      Objective:~      To explore the shared change of roles and responsibilities of patients and caregivers by~     studying the social experience of cancer caregiving.~      Eligibility:~      English speakers ages 18 and older who are one of the following:~      A cancer patients at the NIH Clinical Center (CC)~      A caregiver of a CC cancer patient~      Design:~      Participants will have been screened by the CC.~      Patients and caregivers will be interviewed separately. This will last up to an hour and a~     half.~      Participants will complete online surveys.~      Participants may have a follow-up phone interview. This will last up to 15 minutes.~   "
76462|NCT02566161|"~     Data on transgenerational effects following nuclear accidents are important for understanding~     fully the consequences of parental exposure to ionizing radiation. Few studies to date have~     had adequate statistical power to detect effects of the magnitude expected based on animal~     data, and most have not been of low-dose, protracted exposures associated with nuclear~     accidents and their aftermath. Although, to date, scant use has been made of the new genomic~     technologies, in Chernobyl-exposed areas of Ukraine and Belarus, excess minisatellite~     mutations have been seen in children born after the accident. We propose a study of~     parent-child trios in which at least one parent was exposed to Chernobyl radiation as a~     clean-up worker (mean dose >=100 mGy) and/or evacuee from a contaminated area (mean >=~     50mGy). The specific aims are to investigate the transgenerational and de novo mutation rates~     of the spectrum of genetic variants in trios, in particular looking at effects in children~     and mapping them to possible parental origin of the chromsome. Together with long-term~     collaborators at the Research Center for Radiation Medicine (RCRM) in Kiev, epidemiologic~     data will be collected for up to 450 trios of parents with preconceptional doses and their~     unexposed offspring. We will use state-of-the-art genomic technologies to characterize the~     landscape of the genomes of the trios to determine whether parental radiation exposure is~     associated with genetic mutations transmitted to the offspring, by examining de novo mutation~     rates, minisatellite mutations, copy number alterations, and variations in telomere length.~     The analysis will be conducted in peripheral blood and/or buccal samples (when blood is not~     available) from complete father-mother-child trios. Doses to the gonads from the time of the~     accident to the time of conception will be reconstructed for all parents using existing~     records supplemented by interview data.~      Trio subjects will be selected from representative populations exposed to radiation from~     Chernobyl who are under active follow-up in the Clinico-Epidemiologic Registry at RCRM. To~     help identify specific effects of paternal and maternal radiation exposure, we will initially~     select sets of trio subjects in five categories: (1) exposed father, unexposed mother; (2)~     unexposed father, exposed mother; (3) both parents exposed; (4) both parents unexposed; and~     (5) a group of high dose emergency workers with acute radiation syndrome. All trio members~     will be invited to the RCRM outpatient clinic for collection of a 20 ml blood sample (or~     buccal cells for those who refuse phlebotomy). Both parents will be asked to complete a~     general questionnaire to obtain demographic and lifestyle data. Then one or both will~     complete detailed dosimetry questionnaires, based on forms used in previous collaborations~     with RCRM and administered by specially trained interviewers. Once 50 trios have been~     recruited (10 from each of the 5 exposure categories), we will conduct an interim evaluation~     of participation rates, sample collection and quality, and dose reconstruction in order to~     modify the protocol as needed. The analytical approach will be to correlate the extent,~     especially for de novo events of genetic alterations in the offspring with parental~     preconceptional radiation dose overall and by parental origin. The statistical power in~     relation to de novo mutations is very high, in excess of 90%, but somewhat lower for trends~     in minisatellite mutations. Study findings will contribute importantly to knowledge of the~     heritable effects of moderate- and low-dose radiation exposure in humans and to radiation~     risk projection. Eventually data from the Trio Study may be shared with the international~     community through dbGap.~   "
77626|NCT02550925|"~     This randomized clinical trial compares group acceptance and commitment therapy (ACT) to~     usual care for cancer survivors experiencing anxiety following the end of cancer treatment.~   "
76463|NCT02566148|"~     Populations from Sub-Saharan Africa represent one of the most dynamic immigration flows in~     France and are among the most exposed to HIV infection and hepatitis B.~      The Parcours study aims to understand, among sub-Saharan African migrants, how social and~     individual factors combine in the course of migration and settlement in France, and influence~     the risk of infection, access to prevention and care, and the effectiveness of care for both~     HIV and hepatitis B diseases.~      The research was conducted in Ile-de-France, where 60% of sub-Saharan African migrants~     reside. It consists in a cross-sectional observational survey, using a life-event history~     approach that reproduces the sequence of different life and health events, and contributes to~     explain the present situation (type of disease management, patient's quality of life) in~     light of all the elements of the past trajectory (administrative, familial, socio-economic,~     professionals).~      A representative survey was conducted between February 2012 and May 2013 in health care~     facilities in Ile-de-France, among three groups of migrants from Sub-Saharan Africa: a group~     living with HIV, a group living with chronic hepatitis B and a group who has neither of these~     diseases. For each group, stratified random sampling was used. The survey was conducted in 24~     hospital services providing HIV care, 20 health care facilities providing hepatitis B care,~     and 30 primary health care facilities.~      Were eligible all patients attending these health care facilities, born in a Sub-Saharan~     African country and with Sub-Saharan African citizenship at birth, aged 18 to 59 years, with~     an HIV diagnosis (HIV group) or chronic hepatitis B diagnosis (hepatitis B group) more than~     three months prior or not diagnosed with HIV or chronic Hepatitis B (reference group).~      Among the patients offered participation, 926 HIV-infected patients, 779 patients infected by~     hepatitis B, and 763 patients without these two diseases participated in the study.~      For all participants, detailed information on socio-demographic characteristics; migration~     and life conditions in France; social, sexual and reproductive life history; and screening~     and care history were collected using a life-event history questionnaire administered~     face-to-face by a specialized interviewer. Health care professionals documented clinical~     information from the medical records. Data was collected anonymously.~   "
76464|NCT02566135|"~     Supraglottic Airway devices(SGAs) like I-Gel and C-LMA ( classic laryngeal mask airway ) have~     been used as a conduit for tracheal intubation using ventilating bougie. General Anaesthesia~     with tracheal intubation is one of the technique for giving anaesthesia. Tracheal intubation~     may become difficult sometimes and endangers patients life. Using SGAs as a conduit for~     tracheal intubation helps in securing airway. This will be further facilitated by using~     ventilating bougie, as it maintains oxygenation.~   "
76465|NCT02566122|"~     Normal values for muscle strength using hand held dynamometer and muscle mass using~     echography are largely unknown. The objective of the present study is to establish normal~     values of these measurements in population living in France.~   "
76466|NCT02566109|"~     The overall of this proposal is to test in community hospitals the utility of a 10-min~     magnetic resonance imaging (MRI) scan protocol combined with proprietary image analysis~     algorithms for detecting early cardiovascular (CV) injury during receipt of chemotherapy for~     breast cancer (BrC) and lymphoma. This technology provides health-care delivery systems with~     a time-efficient method to identify those at risk of a future CV event so that prevention can~     be implemented to prolong survival and reduce morbidity in cancer survivors.~   "
76467|NCT02566096|"~     This study aims to compare the analgesic efficacy of transversus abdominis-plane block with~     bupivicaine versus bupivacaine with morphine in patients undergoing major abdominal cancer~     surgery.~   "
76468|NCT02566083|"~     Post-approval study to evaluate the rates of visual distortions for patients requiring >2.0 D~     of corneal astigmatism correction~   "
76469|NCT02566070|"~     This multi-center, prospective, randomized comparative effectiveness intervention study will~     evaluate continuous feeding (CGF) and bolus gastric feeding (BGF) protocols and their effect~     on delivery of prescribed nutrition and feeding intolerance in mechanically ventilated~     critically ill children for up through 12 hours post achievement goal feeds or exclusion from~     feeding protocol, whichever comes first, to a maximum of 10 days.~   "
76470|NCT02566057|"~     This study evaluates whether prospective pharmacogenetic testing is cost-effective in~     affecting clinical treatment outcomes in patients with early-phase psychosis.~   "
76471|NCT02566044|"~     This is a study of multiple doses of inhaled QBW276 in patients with cystic fibrosis on top~     of standard of care. The study will be divided into 3 Cohorts. Cohorts 1 and 2 are designed~     to be a randomized, double-blind, placebo-controlled, parallel arm, multiple dose study to~     assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of inhaled QBW276~     over 1 week (cohort 1) or 2 weeks (cohort 2) in patients with cystic fibrosis regardless of~     their genotype.~      In contrast, cohort 3 is a randomized, double-blind, placebo-controlled, cross-over design,~     multiple dose study to assess the efficacy, safety, tolerability and pharmacokinetics of~     inhaled QBW276 over 4 weeks in patients with cystic fibrosis who are homozygous for the~     F508del mutation.~   "
76472|NCT02566031|"~     To demonstrate superiority of QVA149 (110/50 μg) once daily compared to tiotropium 18 μg once~     daily in terms of trough forced expiratory volume in 1 second (FEV1) (mean of 45 min and 15~     min pre-dose) following 12 weeks of treatment in mild to moderate symptomatic COPD patients~   "
76473|NCT02566018|"~     This study is set to evaluate a proposed standard for the treatment of proximal humerus~     fractures~   "
76474|NCT02566005|"~     A randomized, prospective trial will be offered to women admitted to the Roosevelt Hospital~     labor floor for labor induction. The hypothesis is that the simultaneous use of a foley bulb~     together with vaginal misoprostol will result in shorter induction to delivery time compared~     with vaginal misoprostol alone~   "
76475|NCT02565992|"~     This study will employ a phase Ib design using the established dose of CAVATAK with~     pembrolizumab in subjects with advanced melanoma for whom pembrolizumab would be considered~     standard of care. Our hypothesis is that oncolysis of melanoma cells by CAVATAK will be~     important in amplifying the T-cell potentiating effects of pembrolizumab.~   "
76476|NCT02565979|"~     The main objective of the study is to investigate if 6 months resveratrol supplementation can~     improve glucose tolerance in overweight/obese individuals. As secondary objectives we want to~     investigate whether resting energy metabolism, intra-hepatic lipid content, physical~     performance, body composition and quality of life change by 6 months resveratrol~     supplementation in these individuals.~   "
76492|NCT02565771|"~     Survival rate of childhood cancers is now reaching 80%. However, early or late complications~     related to surgery, chemotherapy and radiotherapy remain high and greatly increase the risk~     of late mortality.~      Health of individuals is closely correlated to the stability of the autonomic nervous system~     (ANS), a key system for maintaining homeostasis in any living species. Efficient computer~     tools allowed the opportunity to assess the intrinsic autonomic regulation of the ANS either~     directly or at a later time by an analysis of the heart rate variability (HRV). These tools~     have become very powerful predictors of cardiovascular morbidity and neurological aging.~     Physical endurance training improves both maximal aerobic capacity and ANS activity.~   "
77627|NCT02550912|"~     The purpose of this study to determine whether high dose vitamin D has positive effect on~     behavior of autistic children.~   "
76477|NCT02565966|"~     The purpose of this study is to better define the potential molecular and anti-inflammatory~     changes induced by the modified Atkins diet in the brains of patients with treatment~     resistant epilepsy. The investigators plan to enroll 30 subjects overall in this study to~     compare serologic and brain tissue specimens. At NYU, investigators plan to enroll 20~     subjects; an estimated ten (10) subjects will consume a modified Atkins diet for 3-4 weeks~     prior to surgery and an estimated ten (10) subjects will consume a non-modified, higher~     carbohydrate diet. Investigators at Saint Barnabas Medical Center plan to enroll 10 subjects~     in this study to compare serologic and brain tissue specimens. Approximately five (5)~     subjects will consume a modified Atkins diet for 3-4 weeks prior to surgery and five (5)~     subjects will consume a non-modified, higher carbohydrate diet. Blood and brain tissue~     specimens will be obtained at the time of surgery and will be compared. The goal of this~     study is to identify whether or not there are changes in neuroinflammation or~     neuroexcitability in the human brain induced by the modified Atkins diet.~   "
76478|NCT02565953|"~     In recent years the use of paclitaxel releasing percutaneous transluminal angioplastic (PTA)~     balloon catheter is spreading in vascular pathology, mainly in stenosis infrainguinal~     arteries. This device combined the mechanical action of PTA balloon with the~     antiproliferative effects of paclitaxel. The use of these devices in venous pathology is~     limited. This devices could improve the treatment of renal dialysis arteriovenous fistula~     stenosis.~   "
76479|NCT02565940|"~     This work also highlights the presence of an unknown virus double-stranded DNA. In this~     project we propose 1) incorporating a bank of 150 samples from patients with diabetic foot~     infection in grades 2-4; 2) to study the microbial flora of a selection of 50 diabetic feet~     previously untreated with antibiotics for bacterial metagenomics, viral metagenomics and a~     minimum of 10 per culturomique; 3) to evaluate the use of targeted quantitative PCR on the~     most frequent new species frequency in the disease and incidentally get a sense of their role~     in the evolution and prognosis of the disease, including failures of and targeted antibiotic~     therapy on all 150 samples.~   "
76480|NCT02565927|"~     The aim of this study was to evaluate the safety and effectiveness of an radioactive airway~     stent loaded with 125I seeds compared to a conventional airway stent in patients with~     malignant airway obstruction caused by both primary and metastatic malignant tumors.~   "
76481|NCT02565914|"~     This is a Phase 3, multicenter, open-label, 2-part rollover study in subjects with CF who are~     homozygous or heterozygous for the F508del-CFTR mutation and who participated in Studies~     NCT02070744, NCT02347657, NCT02516410, NCT02392234, NCT02412111, and NCT02508207. The study~     is designed to evaluate the safety and efficacy of long term treatment of VX-661 in~     combination with ivacaftor.~   "
76482|NCT02565901|"~     This partially randomized phase I/II trial studies the side effects and how well sirolimus~     works when given together with docetaxel and carboplatin in treating patients with~     hormone-resistant prostate cancer that has spread to other places in the body. Biological~     therapies, such as sirolimus, use substances made from living organisms that may stimulate or~     suppress the immune system in different ways and stop tumor cells from growing. Drugs used in~     chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of~     tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them~     from spreading. Giving sirolimus together with docetaxel and carboplatin may kill more tumor~     cells.~   "
76483|NCT02565888|"~     This study aims to provide the evidence that 150mg of cobicistat will have the same effect on~     the pharmacokinetics of daclatasvir 30mg QD as 100mg of ritonavir, when given together with~     atazanavir 300mg.~   "
76484|NCT02565875|"~     Obstetrics and Gynecology residents, fellows and attending physicians will be randomized to~     view one of two educational presentations of equal duration. The intervention presentation~     will demonstrate the use of a standardized language for effective communication of~     laparoscopy commands. Both groups will be asked to perform a simulated laparoscopic task.~     Participants will be timed and use of the standardized language will be tracked and~     tabulated. The primary outcome of interest is whether the use of standard commands during a~     simulated laparoscopic task is associated with sooner completion of the task. This may~     translate into improved efficiency in the operating room.~   "
76485|NCT02565862|"~     This study aims to provide clinical information on a potential drug-drug interaction between~     daclatasvir and metformin.~   "
76486|NCT02565849|"~     The Sickle Cell Anemia (SCA) is a recessive genetic condition, monogenic, resulting in~     defects in the red cell structure. In the investigators' country, this disease affects about~     3,000 children each year and is considered one of the most prevalent disorders among the~     group of existing hereditary diseases.~      The lungs are frequently affected in this disease by Acute Chest Syndrome (STA). Besides~     being the leading cause of death and the second leading cause of hospitalization in SCA, the~     STA is correlated with cognitive impairment frame these patients, resulting secondary Stroke~     vaso-occlusion of capillaries that supply the brain tissue.~      Traditional tests of pulmonary function allow assess whether the person has any commitment in~     the respiratory system, whether obstructive, restrictive or mixed. To run these tests it is~     necessary that the patient understands and performs a forced expiratory maneuver to obtain~     reliable results. In the particular case of SCA, performing these tests it is very difficult~     due to the presence of cognitive impairment of varying degrees. This results in~     underdiagnosis of early changes in the lung parenchyma during the therapeutic window,~     committing the proper monitoring and treatment offered to these patients.~   "
76487|NCT02565836|"~     This study aims to assess a fixed-dose regimen of activated prothrombin complex concentrate~     (FEIBA VH, Baxter) versus the variable, manufacturer recommended, dose regimen of inactivated~     prothrombin complex concentrate (Kcentra, CSL Behring) for reversal of warfarin-associated~     major hemorrhage.~   "
76488|NCT02565823|"~     The purpose of this study is to find out whether exercise leads to changes in the blood that~     are produced by exercised muscles and if these changes produce new hormones that affect the~     body's regulation of sugar and body weight.~   "
76489|NCT02565810|"~     A study comparing the use of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects~     with Rheumatoid Arthritis.~   "
76493|NCT02565758|"~     This is an open-label dose escalation study designed to evaluate the safety and~     pharmacokinetics of ABBV-085 and determine the recommended Phase 2 dose (as monotherapy or in~     combination with standard therapies) in subjects with advanced solid tumors.~   "
76496|NCT02565719|"~     NAPs have been previously shown to clear serum hepatitis B virus surface antigen (HBsAg) both~     preclinically (in duck HBV infected ducks) and in human patients. REP 2139-Ca mediated HBsAg~     clearance acts synergistically with immunotherapeutic agent pegylated interferon-alpha 2a to~     restore host immunological control of HBV infection. REP 2165 is a version of REP 2139 which~     has been shown preclinically to retain antiviral activity with lower accumulation in the~     liver.~      Both REP 2139 and REP 2165 used in this protocol are formulated as magnesium chelate~     complexes, which improve their administration tolerability. This open label, randomized and~     controlled study will examine the safety and efficacy of REP 2139-Mg and REP 2165-Mg therapy~     in patients with HBeAg negative chronic hepatitis B when used in combination with tenofovir~     disoproxil fumarate and pegylated interferon alpha-2a.~   "
76497|NCT02565706|"~     This study is evaluating the WIC Fresh Start program, a theory-driven, web-based nutrition~     education lesson to promote farmers' market fruit and vegetable purchases and consumption~     among women enrolled in the Special Supplemental Nutrition Program for Women, Infants and~     Children (WIC).~   "
76498|NCT02565693|"~     There is a marked lack of evidence on the optimal prevention of ischaemic stroke in patients~     with atrial fibrillation and a recent intracerebral haemorrhage (ICH) during treatment with~     oral anticoagulation. These patients are currently treated with vitamin K antagonists,~     antiplatelet drugs, or no antithrombotic treatment, depending on personal and institutional~     preferences. Treatment with a direct oral anticoagulant like apixaban might be an attractive~     alternative in terms of a low risk of recurrent ICH, while at the same time being effective~     for the prevention of ischaemic stroke. This study aims to obtain reliable estimates of the~     rates of vascular death or non-fatal stroke in patients with atrial fibrillation and a recent~     anticoagulation-associated intracerebral haemorrhage who are treated with apixaban versus~     those who are treated with antiplatelet drugs or no antithrombotic drug at all.~      This study has a multi-centre, phase II, randomised, open-label clinical trial with blinded~     outcome assessment design.~   "
76499|NCT02565680|"~     Acute urticaria is common and affected 12% of population. 400 patients come in department~     emergency of Toulouse each year and there aren't many studies in literature which evaluate~     the glucocorticoids treatment. The standard treatment of urticaria is antihistamines H1, but~     glucocorticoids treatment administered orally for short course would permit to increase~     quickly acute urticaria uncomplicated. Clinical trial, prospective randomized double blinded~     of adults with acute urticaria less 24 hours duration and no take treatment urticaria before.~   "
76500|NCT02565667|"~     The most challenge for the surgery of low rectal carcinoma was whether to perform low~     anterior resection (LAR) and preserve anal function improving the quality of life for~     patients, for which anastomotic leak is a great obstacle with about 5-10% incidence in~     reported literature. Up to now, kinds of surgical devices have been employed to reduce~     anastomotic leak rate after LAR. Most of these anastomotic devices could not resolve the~     problem of dog ear phenomena. In the present clinical trial, the investigators use a double~     purse-string rectal anastomosis with KOL staple in laparoscopic anterior rectal resection for~     low or ultra-low rectal carcinoma, which will resolve the problem of dog ear. The~     investigators aim to demonstrate the safety, effectiveness of this procedure and establish a~     standard method for laparoscopic (ultra-)low anterior rectal resection.~   "
76501|NCT02565654|"~     Irritable bowel syndrome (IBS) is a common disease and the pathogenesis of this disease~     includes central and peripheral mechanisms. In recent years, there were many studies~     suggesting that microbiota in the intestine may play an important role in the IBS.What's~     more, small intestinal bacterial overgrowth (SIBO) may be an important pathogenic factor for~     IBS and the use of antibiotics may be beneficial. Therefore, the investigators intend to~     explore the efficacy of rifaximin for IBS-D in Chinese population.~   "
76502|NCT02565641|"~     This study will evaluate the efficacy and safety of oral capecitabine plus intravenous (IV)~     gemcitabine in participants with locally advanced or metastatic pancreatic cancer. The~     anticipated time on study treatment is 3 to 12 months, and the target sample size is 56~     individuals.~   "
76503|NCT02565628|"~     This study is designed to assess safety, tolerability and pharmacokinetic data for multiple~     doses of PF-06669571 in subjects with idiopathic Parkinson's disease. In addition, this study~     will assess whether PF-06669571 is able to demonstrate superior efficacy compared with~     placebo in the treatment of the motor symptoms of idiopathic Parkinson's disease.~   "
76504|NCT02565615|"~     The study is to verify atorvastatin effectiveness and safety in Chinese population, and~     explore the optimal atorvastatin regimens in high-to-moderate risk for ASCVD。~   "
76505|NCT02565602|"~     This study aims to: 1) quantitatively assess parameters of bone calcium balance in healthy~     postmenopausal Asian women of Chinese descent; 2) assess possible ethnic differences in~     calcium metabolism by direct comparison of acquired data in Chinese postmenopausal women with~     those acquired earlier in Caucasian postmenopausal women using the same methodology; 3)~     assess differences in calcium and strontium metabolism in parallel to evaluate if strontium~     stable isotopes can be used for tracing bone calcium metabolism qualitatively~   "
76506|NCT02565589|"~     To investigate natural killer (NK) cell activities, circulating cytokine levels and~     peripheral blood mononuclear cell (PBMC) cytokine production status in critically ill~     patients.~   "
76507|NCT02565576|"~     The purpose of this study is to evaluate safety, tolerability,~     pharmacokinetics/pharmacodynamics and efficacy of CFZ533 as an add-on therapy to standard of~     care in patients with moderate to severe myasthenia gravis (MG).~   "
76561|NCT02564874|"~     The objective of this study is to determine the effect different sources and forms of~     discretionary foods have on dietary compensation and energy intake in healthy adults in a~     free living, real world setting. Specifically, this pilot study will compare the effect of~     the greatest caloric sources of savory and sweetened discretionary foods in the American diet~     (savory snacks v. sugar-sweetened beverages). The rationale for conducting this study is to~     test the mechanism whereby sugar-sweetened beverages are hypothesized to relate to weight~     gain and obesity above and beyond other discretionary foods (lack of energy intake~     compensation due to liquid form of the beverage), since the evidence for this topic is~     limited. The subject population will be 20 men and women between the age of 18 and 59 who are~     overweight by body mass index (BMI ≥ 25 kg/m2), generally healthy, consume sugar-sweetened~     beverages or , and are willing to incorporate a sweetened beverage or a savory snack into~     their usual diet in the 4 week period.~   "
76508|NCT02565563|"~     The purpose of the study is to gain greater insight into Eye Movement Desensitisation~     Reprocessing (EMDR). EMDR is an NHS recommended treatment, which can significantly reduce~     trauma symptoms. There is some debate regarding how it actually works, however there is~     evidence to suggest that the eye movements component helps reduce anxiety and increase~     relaxation levels. To measure these arousal levels during EMDR previous research has used~     electrocardiography (ECG) to measure heart rate, which offers insight into the effectiveness~     of eye movements (EM). All studies to date have used ECG to measure arousal levels which~     requires technical knowledge to administer and interpret. Furthermore, applying electrodes to~     a patient experiencing PTSD may heighten anxiety. The present study will use new technology~     which is a small device that would be gently attached to the end of the patient's index~     finger. This device is very similar to one that measures oxygen levels in the blood and~     therefore is a very simple piece of equipment and should cause no discomfort to the patient.~     The study also requires patient's faces to be video recorded throughout and it will only be~     their face that is recorded. This is to match the stages of treatment (i.e. when EM starts~     and stops) to their corresponding arousal level outcome. The new technology will digitally~     measure the patient's anxious and relaxed arousal levels during EM and no EM treatment~     sessions. 10 NHS patients would be recruited to receive two treatment sessions; one with EM~     and one without and then continue with treatment as usual without any of the recording~     devices. EM and no EM phases occur at least three times within a treatment session and~     therefore several measurements can be taken and analysed.~   "
76509|NCT02565550|"~     To determine the efficacy of a low FODMAP diet in IBS patients and whether gut microbiota~     community is associated with its efficacy.~   "
76510|NCT02565537|"~     The investigators are comparing outcomes of LASIK surgery using a high definition~     wavefront-guided laser to a wavefront-optimized laser in patients with nearsightedness with~     and without astigmatism.~   "
76511|NCT02565524|"~     Early onset schizophrenia early dissociative disorder is a rare disorder with a low~     incidence of approximately (1/5000 to 1/20000). Its link with autism spectrum disorders~     remains unknown although both are serious neurodevelopmental diseases. As part of the~     2011-2013 Interregional hospital Clinical Research program, University Department of Child~     and Adolescent Psychiatry Pediatric Hospitals of CHU de Nice Lenval identified patients with~     a complex phenotype characterized by an early schizophrenia associated with autism spectrum~     disorders and developmental disabilities in mild to moderate. This phenotype could be a new~     syndrome.~      The goal of our project is to define the genetic causes of this phenotype. The technique of~     high throughput sequencing will be used to obtain the sequence of exomes of these patients~     and their families. This study will therefore be important to give an accurate diagnosis for~     patients and their families. Moreover, we believe that this project will identify new genes~     involved allowing a better understanding of the pathophysiology. Recent studies show the~     involvement of mutations in several genes (eg NRXN1 and UPF3B) in these different clinical~     phenotypes. However, the genetic basis of the childhood and early onset schizophrenia are~     much less well known than those of autism spectrum disorder~   "
76512|NCT02565511|"~     The purpose of this study is to test whether two investigational drugs called CAD106 and~     CNP520, administered separately, can slow down the onset and progression of clinical symptoms~     associated with Alzheimer's disease (AD) in participants at the risk to develop clinical~     symptoms based on their age and genotype.~   "
76513|NCT02565498|"~     This study is designed to determine if preoperative image guided radiation therapy (IGRT)~     delivered using intensity modulated radiation therapy (IMRT) followed by surgery results in~     similar short-term wound healing complications as surgery followed by postoperative IGRT in~     patients with extremity or truncal soft tissue sarcoma. Half of the patients will receive~     preoperative radiotherapy, half will receive postoperative radiotherapy.~   "
76514|NCT02565485|"~     Epidural anesthesia, the most common method of pain control in labor, can contribute to~     alterations in maternal blood pressure and/or fetal heart rate changes. As a result, the~     administration of an IV fluid bolus (preload) is standard prior to epidural placement.~     However, the optimal volume of preload is unknown and no clinical trials have evaluated a~     risk-factor based approach to dosing. Studies in the critical care, trauma, and obstetric~     literature have suggested that a narrow pulse pressure (difference between systolic and~     diastolic blood pressures) is a marker of reduced intravascular volume status and may~     identify women at a higher risk for new onset fetal heart rate changes after epidural~     placement. Therefore, the purpose of this study is to assess if an increased IV fluid preload~     bolus among women with a narrow pulse pressure reduces the risk of new onset fetal heart rate~     changes after epidural placement.~   "
76515|NCT02565472|"~     The goal of this study is to determine subjective gastrointestinal tolerance response and~     differences in breath hydrogen response following the consumption of two types of juice. This~     double-blind crossover study requires participants to arrive to the lab 12 hours fasted,~     consume 12 oz of juice and complete gastrointestinal tolerance questionnaires as well as~     produce samples for breath hydrogen analysis at various time points over the next 3 hours.~     Subjects will be asked to complete additional questionnaires at 12 and 24 hours post~     consumption, from home. Subjects will also be asked to keep a food record for 24 hours prior~     to their scheduled visit times to assure compliance.~   "
76516|NCT02565459|"~     The general aim of the present study is to test a cell therapy with third-party ex-vivo~     expanded bone marrow-derived mesenchymal stromal cells (MSCs) as a strategy to induce~     tolerance in kidney transplant recipients with a deceased donor. MSCs will be prepared~     accordingly to established protocols, starting from the remnants in the bag and filter at the~     end of the bone marrow infusions. From these samples, MSCs will be expanded in good~     manufacturing practice (GMP) approved facilities and used for the present study in patients~     undergoing kidney transplantation.~      The proposed study will be developed in two phases: i) a pilot explorative~     safety/biologic-mechanistic phase (Phase A), ii) a pilot efficacy phase (Phase B).~   "
76562|NCT02564861|"~     This is a randomised, double-blind, placebo-controlled multiple dose study designed to~     explore the safety, tolerability and PK of DS-1971a following oral administration over 14~     days to healthy male and female subjects. Each participant receives lidocaine as a local~     anaesthetic before inserting the intravenous cannula.~   "
77628|NCT02550899|"~     A randomized study to evaluate the safety and effects of transanal submucosal polyacrylamide~     hydrogel injection therapy for anal incontinence.~   "
76517|NCT02565446|"~     A variety of liver insults lead to pathological changes in liver architecture that culminate~     in cirrhosis. While invasive liver biopsy was required to detect cirrhosis, the development~     of magnetic resonance elastography (MRE) has revolutionized our ability to detect liver~     fibrosis through non-invasive means that involve measurement of liver stiffness. However, a~     number of pathological findings occur in liver in response to various insults that precede~     cirrhosis and are clinically important to identify such as steatosis associated with NASH,~     inflammation associated with viral hepatitis, and congestion associated with cardiac~     hepatopathy. Detection of such entities provides essential diagnostic, prognostic, and~     treatment information but yet is not available non-invasively. Recent murine studies from~     this group of investigators has identified that MRE technology can be adapted to~     non-invasively detect these conditions. Implementing this into the practice will transform it~     by obviating the need for invasive liver biopsies in patients suspected of having such forms~     of suspected liver disease. This will differentiate Mayo from other institutions where such~     technology is not available.~      An additional aim of this study is to examine the impact of obstructive sleep apnea (OSA) on~     the pathogenesis of nonalcoholic fatty liver disease (NAFLD), both common comorbidities of~     obesity. Recent evidence indicates a potential link between OSA and severity of NASH and~     fibrosis, but the mechanisms of OSA- associated hypoxia on liver disease progression in NAFLD~     is unclear. This study offers the unique opportunity to analyze this association, as the~     study population will undergo routine evaluation for OSA, as part as the preoperative work-up~     prior to bariatric surgery.~   "
76518|NCT02565433|"~     The aim of the study is to assess prospectively the impact of radiosurgery on the quality of~     life in patients with brain metastases.~   "
76519|NCT02565420|"~     Perioperative volumes of saline cause a mild acidosis compared with buffered fluids. On the~     other hand, saline administration maintains plasma osmolality and better repletes vascular~     volume which is an important goal of perioperative fluid administration. Currently, there is~     no convincing evidence that either saline or buffered solutions are preferable. Consequently,~     both types of fluid remain in common use at the Clinic and worldwide.~      There has never been a large trial of perioperative saline and balanced salt solutions~     comparing the incidence of major complications including acute kidney injury. The~     investigators primary objective is thus to determine the relative safety of perioperative~     saline and lactated Ringer's solution. Specifically, the investigators propose to test the:~        1. Primary hypothesis that a composite of major in-hospital postoperative complications is~          lower in patients given lactated Ringer's solution compared to normal saline.~        2. Secondary hypothesis that acute kidney injury, measured by AKIN criteria, is lower in~          patients given lactated Ringer's solution compared to normal saline.~      The acquisition cost of saline and lactated Ringer's solutions is similar in the United~     States. (Curiously, buffered solutions are far more expensive than saline in Great Britain.)~     But to the extent that one fluid or the other provokes more complications, cost of care may~     be increased with that fluid selection. Cost may also be increased by the need for additional~     electrolyte monitoring and electrolyte replacement.~      The investigators will therefore secondarily conduct an economic evaluation to determine the~     relative incremental hospital cost of each fluid. To the extent that one fluid or the other~     reduces cost (assuming similar complication rates), the Clinic will be able to reduce cost by~     specifying the appropriate fluid without impairing quality.~      Evidence that one fluid or the other causes few complications would be a strong quality~     indicator that the Clinic should standardize perioperative fluid selection.~   "
76520|NCT02565407|"~     This study investigates the effect of a robot-aided 2-day proprioceptive training of the~     wrist on the proprioceptive and motor function of the wrist/hand complex in patients with~     proprioceptive impairment. The wrist proprioceptive training consists of active movement~     training with augmented haptic and vibro-tactile feedback provided by a patented wrist~     robotic system (US Serial No. 62/136,065). This study protocol can be applied to a variety of~     clinical and non-clinical populations. The purpose of this study is to obtain preliminary~     data on the effectiveness of the proprioceptive training in subjects with cortical stroke or~     peripheral sensory neuropathy.~   "
76521|NCT02565394|"~     Will targeted intraoperative exercises performed by surgeons during surgery, mitigate high~     physical and mental demands while enhancing performance during surgical procedures?~   "
76522|NCT02565381|"~     The QUIT (Quitting with Usual Care, Incentives, and Technology) Smoking Study is a 3-arm~     pilot randomized controlled trial that will test the effect of 2 different experimental~     smoking cessation interventions relative to a control condition in homeless cigarette~     smokers. All participants will receive free transdermal nicotine patches and weekly in-person~     smoking cessation counseling. In addition, participants randomized to the first experimental~     condition will receive financial rewards for biochemically-verified smoking abstinence, and~     participants randomized to the second experimental condition will be enrolled in a text~     messaging program to support smoking abstinence.~   "
76523|NCT02565368|"~     This study is a randomized, open-label, single dose, 2-way crossover study to compare the~     pharmacokinetic characteristics of CKD-395 0.5/1000 mg in healthy male volunteers.~   "
76524|NCT02565355|"~     Recurrent Abdominal Pain (RAP) in children is common and causes significant functional~     impairment and poor quality of life. Lifestyle factors such as diet, anxiety, and stress are~     important triggers of abdominal pains, but there is lack of high quality research evidence on~     optimal treatment modalities in children. This study aims to evaluate the effect of food~     elimination on abdominal pain frequency and severity in a cohort of children with abdominal~     pain associated Functional Gastrointestinal Diseases (FGID). The primary outcome will be a~     comparison of abdominal pain frequency and severity between standard therapy and targeted~     food elimination, based on IgG antibody results to a multiple food antigen panel. The~     investigators anticipate that 'targeted dietary elimination' as a treatment strategy will~     resolve abdominal pain and improve quality of life in children.~   "
76525|NCT02565342|"~     The sensory innervation of the clavicle remains an area of debate. Regional nerve blocks~     aimed at relieving pre- and post-operative pain include the superficial cervical plexus~     blocks, interscalene blocks and a combined version of the above. In this case study, the~     investigators aim to describe the protocol used in a university hospital: general anaesthesia~     with interscalene brachial plexus block, followed by optional iv morphine administration in~     phase 1 recovery and oral oxycodone on the ward.~   "
76526|NCT02565329|"~     The study aimed to evaluate the correlation between the serum lactate concentration ed~     cumulative Pringle time after liver resection. In addition, the correlation between lactate~     clearance and clamping time was investigated.~   "
76563|NCT02564848|"~     This study will examine the outcomes of lumpectomy, surgery to remove a tumor, without~     sentinel node biopsy (SNB) for women at least 65 years of age with clinically node-negative~     breast cancer. Clinically node-negative means that during a physical exam your doctor cannot~     feel or see that any lymph nodes near the breast area are swollen and there is also no~     imaging evidence, such as from a mammogram, of nodal involvement.~   "
76527|NCT02565316|"~     The aim of this study is to assess the efficacy of Nepeta menthoides as an anti anxiety~     herbal remedy for depressed patients , in a 6 week randomized double-blind controlled trial.~     A total of 70 adult outpatients between 18-65 ages referring to psychiatry clinic of Shiraz~     medical university, who having depression according to Persian‐language version of the Beck~     Depression Inventory‐Second edition and get score above 11 according to Persian version of~     Beck Anxiety Inventory (BAI) and diagnosis is confirmed by at two psychiatrists are randomly~     allocated into two groups and assign to receive 400 mg of freeze dried powder of Nepeta~     menthoides or 50 mg of sertraline in the uniformed capsules twice daily (in the morning and~     1-2 hours before sleeping time at night). Exclusion criteria were pregnancy and lactation,~     allergy to N. menthoides and Lamiaceae family, patients with suicidal thoughts or previous~     suicidal attempt, patients with unstable cardiac, renal and hepatic diseases, seizure and~     hypothyroidism and patients who used substances or alcohol and patients who had indication~     for electroconvulsive therapy.. Severity of anxiety (by Persian version of Beck Anxiety~     Inventory (BAI)) and also common possible side effects of drugs will assess in baseline, 2nd~     week, 4th week and then two weeks after the end of the intervention (in 6th week)~   "
76528|NCT02565303|"~     Ropivacaine is one of commonly used anesthetics for spinal anesthesia. Usually L2-3 or L3-4~     intervertebral space is chosen for spinal anesthesia. The efficacy of ropivacaine injected~     into subarachnoid space depends on the given dose and the chosen intervertebral space.~     Appropriate dose could satisfy the requirement of operation and reduce incidence of the~     adverse reaction. But it is not certain about the minimum effective dose of ropivacaine in~     cesarean section through the two intervertebral spaces, respectively. This study is being~     conducted to find the minimum effective doses for L2-3 and L3-4 spinal anesthesia in cesarean~     section.~   "
76529|NCT02565290|"~     The effect of anti-inflammatory substances on the dynamics of the fetal ductus arteriosus is~     well documented, but the anti-inflammatory property of polyunsaturated fatty acid omega-3~     about changing this dynamic is not established. This study evaluate the relationship between~     supplementation of omega-3 in the dynamics of the fetal ductus arteriosus in the third~     trimester. Women with gestational between 28 to 32 weeks will receive capsules of omega-3 or~     placebo, to be consumed daily for 3 weeks.~   "
76530|NCT02565277|"~     To assess the impact of influenza vaccination on the overall systemic inflammatory response~     in patients undergoing cardiac surgery and investigate functional and clinical outcomes in~     vaccinated patients postoperatively.~   "
76531|NCT02565264|"~     This study is an open prospective clinical trial. The objective is to evaluate the effect of~     autologous exosomes rich plasma on cutaneous wound healing. The participants are patients~     with intractable cutaneous ulcers (e.g. rheumatic disease, peripheral arterial disease,~     chronic venous insufficiency, decubitus or burns). The participants will be treated~     autologous exosomes rich plasma every day for 28 days. The cutaneous wound healing will be~     evaluated by the length, width and depth of the wound.~   "
76532|NCT02565251|"~     Severe sepsis and septic shock are among the leading causes of morbidity and mortality in~     patients admitted in the ICU, being responsible for approximately 200000 deaths/year in the~     USA and 150000 in Europe. Recognizing the early signs of sepsis and the different stages of~     this condition may lower the associated morbidity and mortality.~      The hemodynamic profile of the septic shock is characterized by the presence of the~     distributive shock, on which we can add elements from the hypovolemic and cardiogenic shocks.~      The objecive of this study is to optimize the volemic resuscitation of the severe septic and~     of the septic shock patient using two minimally invasive methods of hemdynamic monitoring~     which both use the same device (Edwards Lifescience). In the same time hemodinamic data will~     be colected by mesuring the inferior vena cava diameter.~   "
76533|NCT02565238|"~     The objective of the study is to confirm safety and efficacy of the BioMonitor 2. The data is~     collected to support the regulatory approval of this product in countries outside the CE~     region.~   "
76534|NCT02565225|"~     The purpose of this study is to evaluate the use, usability and feasibility of an Application~     (App) for patients with rheumatoid arthritis with diary functionalities, in patient-physician~     interaction.~   "
76535|NCT02565212|"~     The investigators aimed to evaluate by the Sniffin' Sticks test the effects on olfactory~     functions of nasal steroids and leukotriene antagonists used for allergic rhinitis.Thirty~     patients with seasonal were included in this study. Patients were randomly divided into three~     groups of 10 patients; group 1 received montelukast sodium and mometasone furoate therapy,~     group 2 received only montelukast, and group 3 only mometasone furoate. Patients' olfactory~     functions were determined using the Sniffin' Sticks olfactory test before and after a month~     treatments.~      Threshold, discrimination, identification, and TDI values were not significantly different~     among the groups before treatment. For Group 1 and Group 3 patients, there were statistically~     significant differences in threshold, discrimination, identification, and TDI values before~     and after treatment (p < 0.05) (Wilcoxon signed ranks analysis) For Group 2 patients, the~     before and after treatment values of threshold, discrimination, identification, and TDI~     showed no significant differences (p > 0.05). According to the findings of our study, MF is~     superior to montelukast in improving olfactory function. Although montelukast has been shown~     to be effective against AR symptoms, its effect on olfactory function was not demonstrated in~     this study.~   "
76536|NCT02565199|"~     The goal of the study is to determine the effect of repetitive transcranial magnetic~     stimulation (rTMS) over the premotor cortex on training-related improvements in motor~     performance and associated neural plasticity.~   "
76537|NCT02565186|"~     This is a prospective, randomized, open-label study in subjects with migraine who have~     completed CoLucid Phase 3 study, COL MIG 301 or COL MIG-302. The study is designed to~     evaluate the safety and tolerability of long-term intermittent use of lasmiditan 100 mg and~     of lasmiditan 200 mg, as the first dose and as a second dose, for the acute treatment of~     migraine. Long term efficacy will also be evaluated.~   "
76564|NCT02564835|"~     The purpose of this study is to determine if individuals with colorectal cancer enjoy yoga~     and to begin to assess whether yoga is effective in improving attention and immune function~     in individuals with colorectal cancer compared to physical activity and usual care.~   "
77705|NCT02549898|"~     The investigators aim to investigate inflammation of cranial and meningeal arteries during~     pharmacologically induced migraine attacks, using ultrasmall superparamagnetic iron oxide~     (USPIO) nanoparticles and black blood imaging (BBI) MRI.~   "
76538|NCT02565173|"~     Phase III trial involving topical application, in both eyes, of trabodenoson ophthalmic~     formulation 3.0% or 6.0% once per day or 4.5% twice per day, placebo twice per day, or~     timolol 0.5% twice per day for 12 weeks in adult subjects with Ocular Hypertension or Primary~     Open-Angle Glaucoma.~      All subjects who meet the study's enrollment criteria following Screening will undergo~     washout of all prohibited medications, including their routine glaucoma medications. During~     the Placebo Run-In Period, placebo is administered twice daily to both eyes in all subjects.~     During the Treatment Period, study drug is applied to both eyes for a total of 12 weeks~     followed by an Observation Period of approximately 7 days wherein no study eye drops are~     instilled.~      The purpose of the study is to assess the efficacy, tolerability, and safety of binocular~     topical application of trabodenoson ophthalmic formulation 3.0% or 6.0% QD or 4.5% BID for 12~     weeks.~      Timolol is being included in the trial in order to have an active control to ensure the~     integrity of the trial from an efficacy perspective; the primary comparator for all~     statistical purposes is the placebo arm.~   "
76539|NCT02565160|"~     Making the diagnosis underlying a painful, swollen joint currently involves aspiration~     followed by numerous microbiological and biochemical laboratory tests. This can be costly,~     time consuming and in the case of an acutely swollen joint, lead to a lengthy inpatient~     admission. There is an unmet need to provide a quick, easy, reliable dipstick like test to~     analyse joint fluid in the community, clinic, or emergency department setting.~      The investigators aim to use well established metabonomic techniques to:~        1. Analyse fluid from patients with swollen joints~        2. Identify potential biomarkers of inflammatory, infective and osteoarthritic causes of~          joint swelling~        3. Correlate this with lubrication and wear properties of the fluid The long term goal is~          to develop time saving, cost effective, non-invasive diagnostic tests to improve~          management of a swollen joint. The biomedical research centre at Imperial provides a~          unique and unparalleled clinical and scientific environment to conduct this research.~          The Imperial College division of Computational and Systems Medicine has an international~          reputation in metabonomics and this, together with the high volume of patients with~          swollen joints treated at Imperial National Health Service Trust (c1000/yr) ensures that~          the study can take place in an environment conductive to success.~   "
76540|NCT02565147|"~     The purpose of this study is to evaluate whether the use of bivalirudin will reduce extent of~     the damage done to the heart muscle in patients who suffered a heart attack, compared to the~     comparator treatment (heparin).~   "
76541|NCT02565134|"~     The study is a Phase II, multi center, randomized, double-blind, placebo-controlled study in~     male and female subjects, aged ≥ 19 years with skin pruritus. All subjects will receive BID~     topical applications of PAC-14028 cream or vehicle for up to 4 weeks.~   "
76542|NCT02565121|"~     The aim of the study is to see whether patients with chronic smell impairment after brain~     injury benefit from a treatment that consists of corticosteroids, and then olfactory training~     in 3 months.~   "
76543|NCT02565108|"~     This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The~     blinded phase only will be described in this record. Participants will be randomized in a 4:1~     ratio to receive GWP42003-P or matching placebo. The hypothesis is that levels of clobazam~     (CLB) and its major metabolite (N-CLB) may be altered (increased or decreased) as a result of~     using GWP42003-P.~   "
76544|NCT02565095|"~     It is well documented that a few days stay in space induces a change in the vestibular-ocular~     reflex reflecting a reinterpretation of sensory inputs following the disappearance of~     gravity. If the change of eye reflexes actually the result of a reinterpretation of sensory~     input, the investigators should also expect to see an alteration of the~     vestibular-cardiovascular reflexes. The modification of these reflexes may modulate the~     carotid baroreflex and thus participate in the post-flight cardiovascular deconditioning.~      The first objective of this project is to study the carotid baroreflex under different supine~     (dorsal, ventral and lateral) inducing different otolith stimulation in normal-gravity.~   "
76545|NCT02565082|"~     Sickle cell disease is a genetic disorder caused by a point mutation on the amino acid~     sequence of the β chain of hemoglobin.~      The most expressive and most frequent complication of the disease is vaso-occlusive crisis,~     dominated by a painful syndrome. In addition to vaso-occlusive crises, many more chronic~     biological disturbances are observed in sickle cell patients.Sickle cell disease is~     considered nowadays as a hypercoagulable state.~      However, the approach used so far to the measure of clotting in sickle cell disease was~     segmented in the sense that the various components of the hemostatic balance were studied~     separately.The thrombin generation test is a functional test which explores the coagulation~     globally, integrating both pro players that anticoagulants actors in the system. The~     investigators already used this test to demonstrate that the hemostatic potential was high in~     a cohort of affected children compared to control children of the same age.~      This test will be used to characterize the hemostatic potential of adult sickle cell patients~     followed at the CHU Brugmann Hospital.~   "
76546|NCT02565069|"~     The primary purpose of this trial is to demonstrate that the utilization of CartoFinder™ 4D~     Local Activation Time (LAT) Algorithm may help identify and improve the outcome for the~     treatment of complex arrhythmias.~   "
76547|NCT02565056|"~     The purpose of this study is to assess the feasibility of conducting a trial to evaluate a~     self-help treatment for depression in people with end-stage renal disease.~   "
76548|NCT02565043|"~     The study is looking at the clinical efficacy, functionality and device performance of a new~     Negative Pressure Wound Therapy (NPWT) system in the management of a variety of wound types,~     in a real-life clinical setting. The study will comprise a prospective, open-labeled,~     multi-center study in a number of care-settings (both hospital and community) in South~     Africa. The patient's reference wound will be randomized to treatment with either~     intermittent or continuous NPWT mode to assess whether the delivery of NPWT via each of these~     therapy settings will have an effect on the rate and quality of wound healing.~   "
76549|NCT02565030|"~     This study will help to provide more up to date prognostic data on the natural history of~     untreated proximal CTEPH which will be helpful in discussions regarding surgical versus~     medical treatment and by exploring the similarities and differences between distal CTEPH and~     IPAH the investigators hope to get insights into disease mechanisms in patients with distal~     CTEPH.~   "
76551|NCT02565004|"~     Background:~      DNA makes up the instruction book for people s cells. Cancer is a disease caused by DNA~     changes that build up and affect cell function. Researchers want to learn more about what may~     cause cancer by testing the DNA of people with the disease and their family members.~      Objective:~      To find DNA changes that may be inherited and may cause or influence whether a person gets~     cancer. To study families with clusters of cancer to find out if there is a DNA mutation~     specific to certain cancers.~      Eligibility:~      People 18 years of age and older who:~      Participated in the familial genetic part of NIH study 09-C-0079, a previous study or had~     family members enrolled in this study~      Design:~      Participants may have been screened in the previous study. They will give permission for~     researchers to use their data and their tissue or blood samples collected in the study.~      Participants may give blood samples.~      At each stage of testing, participants will meet with a genetics health care provider. The~     provider will explain the tests and answer questions.~      If researchers find a DNA change that might increase the risk for cancer or other health~     issues, they will confirm this result in a testing lab. This will require a blood sample.~      Participants personal DNA data and health information will be put in a database for research~     purposes.~   "
76552|NCT02564991|"~     Background:~      The way alcohol affects brain structure has been widely studied. But the way it affects all~     parts of the brain is still unknown. Researchers want to use magnetic resonance imaging (MRI)~     scans to study brain structure and function. They hope this will help them better understand~     changes that happen in brain regions during treatment of alcohol use disorders.~      Objectives:~      To study changes in the brain by using MRI in people with and without alcohol use disorders.~     To study how brain changes affect gait, balance, cognitive ability, and behavior. To see how~     the brain recovers when alcohol use stops.~      Eligibility:~      People with alcohol dependence who are currently hospitalized in a particular unit at NIH.~      Healthy volunteers 30 60 years old without an alcohol use disorder.~      Design:~      Participants will be screened under a separate protocol.~      Participants will give a urine sample for a drug test and pregnancy test at each study visit.~     They will also have to pass a breath alcohol test.~      At the first visit, participants will have an MRI. The scanner is a metal cylinder in a~     strong magnetic field. Participants will lie on a table that slides in and out of the~     cylinder.~      They will do behavior and memory tasks outside the scanner.~      They will have gait and balance tested. They will have to stand on both legs, stand on just~     one leg, and walk in a straight line. They will perform each task with eyes open, then with~     eyes closed.~      They will have tests of memory, thinking, and problem solving.~      Some participants will have a second visit. They will have another MRI and repeat some of the~     behavior and memory tasks.~   "
76553|NCT02564978|"~     Background:~      Age-related macular degeneration (AMD) is the main reason older people lose their vision. It~     affects the macula, the center of the retina needed for sharp, clear vision. Researchers want~     to see if an antibiotic can help people with an advanced form of AMD, Geographic Atrophy~     (GA).~      Objective:~      To see if minocycline is safe for people with GA and if it helps preserve their vision.~      Eligibility:~      People age 55 and older who have GA in at least one eye.~      Design:~      Participants will be screened with physical exam, medical history, blood tests, and eye exam.~      Participants will take minocycline. They will take 1 pill twice a day for at least 3 years.~      Participants will have a minimum of 11 study visits. (But they are not every 3 months.). At~     each visit, participants will have a medical history. They may have:~      Blood tests.~      Eye exam. Vision, eye pressure, and eye movements will be checked. The pupils may be dilated.~     The inside of the eyes may be photographed.~      Their thyroid gland felt while they swallow.~      Microperimetry. They will sit in front of a computer and press a button when they see a light~     on the screen.~      Fluorescein angiography. An intravenous line (IV) will be placed in an arm vein. A dye called~     fluorescein will be placed in the IV and travel through the veins to the blood vessels in the~     eyes. A camera will take pictures of the dye as it flows through the eye blood vessels.~   "
76554|NCT02564965|"~     The purpose of this study is to determine optimal treatment strategies for symptomatic~     walled-off pancreatic necrosis( WON).~   "
76555|NCT02564952|"~     This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The~     open-label extension phase only will be described in this record. All participants will~     receive the same dose of GWP42003-P. However, investigators may subsequently decrease or~     increase the participant's dose until the optimal dose is found.~   "
76556|NCT02564939|"~     Delirium is a common morbid condition in hospitalized adults. Treatment of delirium has been~     unsatisfactory and prevention is the preferred goal. Based on limited experimental research,~     ramelteon appears to have promise for prevention. This study will evaluate ramelteon in~     prevention of delirium in a hospitalized adult population age 65+ in a double-blinded RCT.~   "
76557|NCT02564926|"~     To evaluate the effect of dapagliflozin on body composition in Korean T2DM subjects.12-month,~     randomised, open-label, parallel-group, multi-centre phase IV study.~   "
76558|NCT02564913|"~     In traditional Chinese medicine (TCM), examination of the tongue plays an important role in~     diagnosis. The characteristics of the tongue(e.g., color of the tongue body, tongue fur,~     teeth-marked tongue) provides some clues and prognosis, which are considered a reflection of~     the body's internal condition. Diabetes mellitus is a metabolic disorder of hyperglycemia,~     which lead to damage the kidneys, eyes, nerves, blood vessels, and heart. Long standing~     hyperglycemia can also be associated with buccal alteration. The purpose of this study was to~     survey on tongue diagnosis and other examinations associated with diabetic mellitus.~   "
76559|NCT02564900|"~     This is an open-label, two-part, multiple study to evaluate the safety and tolerability of~     DS-8201a in patients with advanced solid malignant tumors.~   "
76560|NCT02564887|"~     Patients with head and neck cancer treated with chemoradiation, often develop a treatment~     associated dysphagia. The common complaint is foods sticking in the pharynx. This study seeks~     to test the Iowa Oral Performance Instrument (IOPI) in the management of treatment induced~     dysphagia following chemoradiation for oral, pharyngeal, laryngeal, hypopharyngeal cancer.~     This pilot study seeks to compare standard exercise therapy plus IOPI to standard exercise~     alone to determine if recovery is enhanced and to determine if rate of recovery is~     accelerated.~   "
88355|NCT02410616|"~     To compare the clinical and cost-effectiveness of blended Cognitive Behavioural Therapy (CBT)~     for adults with major depressive disorder (MDD) with treatment as usual (TAU) in Swiss~     patients in secondary care~   "
76566|NCT02564809|"~     The investigators will conduct a 8-week proof-of-concept randomized controlled trial to~     provide preliminary evidence of efficacy of Fit Brains (Rosetta Stone Canada) training -- a~     mobile cognitive training program -- on cognitive and brain plasticity in older adults. The~     investigators will also explore whether Fit Brains training paired with a brief bout of~     exercise would enhance the potential cognitive benefits of Fit Brains. In addition, the~     investigators will explore the long-term effects of cognitive training by performing a 1-year~     follow-up measurement (i.e., 1-year after study completion).~   "
76567|NCT02564796|"~     Cyanotic congenital cardiac patients require higher hemoglobin concentrations (red blood cell~     levels) for optimal oxygen delivery to the body. Prophylactic erythropoietin (EPO) and iron~     can prevent and/or decrease the amount of blood transfusions needed in this population. We~     seek to investigate if EPO and iron make a clinically significant difference in the number of~     transfusions given to these patients and the morbidity associated with it.~   "
76568|NCT02564783|"~     PURPOSE OF THE STUDY~      The main purpose of this study is to find out what is the true burden of surgical conditions~     in pediatric population in a well defined geographical rural area in western Kenya.~   "
76569|NCT02564770|"~     This is a cross-sectional, observational study examining the factors leading to the~     therapeutic decision to use MabThera (rituximab) in participants with RA. Routine~     rheumatology clinical practice data of participants who are being or have been treated with~     rituximab for RA will be collected and analysed in this chart review.~   "
76570|NCT02564757|"~     The investigators will examine if pregnancy increases risk of ventral hernia recurrence~   "
76571|NCT02564744|"~     This is an open label, multicenter, non-randomized phase 2 (with safety run-in phase)~     clinical study. The study will consist of a screening period, a treatment period, an end of~     treatment visit, and a follow-up period.~   "
76572|NCT02564731|"~     This prospective cohort study is designed to observe of the effect of intervention therapy on~     the long-term prognosis of children with bronchiectasis. The main purpose of the study was to~     evaluate the degree of deterioration of lung function, to observe and compare the quality of~     life, the time of pulmonary exacerbation, and the changes of lung image.~   "
76573|NCT02564718|"~     The purpose of this study is to find out whether rivaroxaban is safe and effective to use in~     children age newborn to less than 6 months and how long it stays in the body and how it is~     used in the body. Safety will be assesed by looking at the incidence and types of bleeding~     events. There will also be a check for worsening of blood clots.~   "
76574|NCT02564705|"~     The aim of this study is to compare outcomes and cost-effectiveness of anterior versus~     posterior surgical treatment for lumbar Isthmic Spondylolisthesis. The primary objective is~     to compare treatment effectiveness in terms of functional outcomes as measured by Oswestry~     Disability Index (ODI) v2.1a and to compare safety outcomes measured by treatment-related~     adverse events. Secondary objectives are to compare treatments in terms of differences in~     pain, quality of life, health utilities, and need for re-operation. Finally, a~     cost-effectiveness analysis will be performed. This analysis will take the form of~     cost-effectiveness if there is a difference in treatment effects or cost-minimization if~     there is no difference in treatment efficacy.~   "
76575|NCT02564692|"~     The purpose of the Alzheimer's Prevention Registry GeneMatch program is to identify a large~     group of people interested in participating in research studies or clinical trials based in~     part on their genetic background. This genetic information will be used to match interested~     individuals to studies, providing a recruitment resource to the Alzheimer's scientific~     community. Interested individuals should visit www.endALZnow.org/GeneMatch to join the~     GeneMatch program.~   "
76576|NCT02564679|"~     Pediatric obesity has become a critical health problem worldwide, increasing the premature~     onset of obesity-related morbidities. This phenomenon has induce an increase in the incidence~     of serious health complications starting in childhood and adolescence. Lifestyle~     interventions, including diet and regular physical activity, are the cornerstone of current~     medical management. Unfortunately, these interventions are often ineffective in providing a~     meaningful and long-lasting weight loss necessary to change health outcomes. It has been~     demonstrated that an early intervention in obesity in children and adolescents, inducing~     weight loss by performing bariatric surgery in carefully selected patients, can dramatically~     reduce the risk of adulthood obesity and obesity-related diseases, including non-alcoholic~     fatty liver disease (NAFLD).~      Recent evidence suggest that bariatric surgery can improve metabolic complications and liver~     involvement in patients affected by morbid obesity.~   "
76577|NCT02564666|"~     Sorafenib is an oral multikinase inhibitor with antiproliferative and antiangiogenic effects~     used as systemic treatment in patients with unresectable hepatocellular carcinoma.~      Although sorafenib has demonstrated many clinical benefits in patients, its adverse cannot be~     ignores.~      This drug occasionally causes severe adverse events (AEs), which include hand-foot skin~     reaction (HFSR), hypertension, diarrhea, anorexia, fatigue, weight loss, and so on. Although~     most adverse events are reversible, they can significantly impact a patient's quality of life~     and occasionally result in dose reduction or discontinuation of therapy Patients are also~     more likely to remain on treatment if they are guided over the difficult initial 4~6wks of~     therapy during which time the development of adverse events following sorafenib treatment~     initiation are most likely to occur.~      Patient education, proactive management and establishing and maintaining open communication~     between patients and the nurse are crucial to the effective management of these adverse~     events.~      This study design is a randomized controlled trial and 64 patients will be randomized to one~     of 2 groups in a 1:1 ratio. 32 patients will be enrolled into the controlled group and the~     rest of 32 patients will be enrolled into the intervention group. The intervention group will~     be received the routine telephone calls of six times at intervals of once a week during 10~15~     minutes (from a well-trained nurse)~      The purpose of this study is to confirm whether an effective intervention that telephone~     counseling and education by a nurse can increase drug compliance for patients with HCC who is~     taking Sorafenib and is to use for developing individual educational program as a fundamental~     data that can be applied for patients taking Sorafenib after investigating patient~     satisfaction by The Satisfaction with information about Medicines Scale(SIMS) tool.~   "
76599|NCT02564367|"~     Multicenter trial in Germany:~      Feasibility Study of Adjuvant Treatment with S-1 in Patients after R0-Resection of~     Adenocarcinoma of the Stomach and Esophagogastric Junction with the aim to show the~     feasibility and tolerability of two different adjuvant S-1 treatment regimens in Caucasian~     patients and to determine the recommended dose for both treatment regimens.~   "
76600|NCT02564354|"~     Exploratory proof of concept study to determine whether intranasal administration of QR-010~     in subjects with cystic fibrosis, homozygous or compound heterozygous for the ΔF508 mutation,~     can increase the function of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR).~   "
76578|NCT02564653|"~     Vietnam has a smoking prevalence that is the second highest among South East Asian countries~     (SEACs). With a population of approximately 90 million, Vietnam also has the second largest~     total number of adult smokers (over 16 million) in SEA. According to the World Health~     Organization (WHO), most reductions in mortality from tobacco use in the near future will be~     achieved through helping current users quit. Tobacco use treatment, as defined by the U.S.~     Preventive Health Service Guideline (Guideline) on Treating Tobacco use and Dependence, is~     evidence-based and highly cost-effective. Yet, in the U.S. and globally, adoption of~     recommended care is suboptimal. The objective of this proposal is to fill the current~     research-to-practice gap by conducting a randomized controlled trial that compares the~     effectiveness and cost effectiveness of two practical and highly replicable strategies for~     implementing evidence-based guidelines for the treatment of tobacco use in public health~     clinics in Vietnam. The proposed implementation strategies draw on evidence-based approaches,~     and the WHO's recently released guidelines for implementing Article 14 of the Framework~     Convention on Tobacco Control (FCTC). The FCTC is an evidence-based treaty that was developed~     by the WHO in response to the globalization of the tobacco epidemic. Vietnam ratified the~     FCTC in 2004; however, they have not taken steps to implement Article 14 which specifies the~     need to integrate best practices for treating tobacco use and dependence into routine~     preventive care. The proposed implementation strategies also build on the growing literature~     that supports the effectiveness of integrating community health workers as members of the~     health care team to improve access to preventive services.~   "
76579|NCT02564640|"~     Tracheal intubation techniques that avoid or minimize pharyngolaryngeal stimulation might~     attenuate the hemodynamic stress response. Tracheal intubation using video laryngoscope needs~     comparatively less airway manipulation so, the investigators expect less hemodynamic response~     while using videolaryngoscope.~   "
76580|NCT02564627|"~     A prospective randomized study, including moderately obese patients will be included.~     Patients will be randomized in 3 groups:~        -  PENS of dermatome T6 with an ambulatory self-applied patch + 1200Kcal/day diet~        -  PENS of dermatome T6 with conventional procedure + 1200Kcal/day diet~        -  Only 1200Kcal/day diet~      The effect on appetite and weight loss will be investigated.~   "
76581|NCT02564614|"~     This open-label study will demonstrate proof-of-mechanism of HIF1A inhibition by a decrease~     of HIF1A mRNA after intravenous (IV) infusion of RO7070179 in participants with~     hepatocellular carcinoma (HCC) who have failed at least one line of systemic therapy. This~     will be a single arm study and all participants will receive RO7070179, 13 milligram per~     kilogram per week (mg/kg/week), 2-hour IV infusion on Days 1 and 4 during Week 1 of Cycle 1,~     followed by once weekly in 6 week cycle. Treatment with RO7070179 will be continued until~     disease progression or unacceptable toxicity.~   "
76582|NCT02564601|"~     This project evaluates the effects of piano training and computerized cognitive training on~     cognitive performance in healthy older adults compared to controls. The project is intended~     for healthy older adults (60-80 years) with little to no previous musical training (less than~     three years of prior musical training or cognitive training and not currently engaged in~     music reading or musical performance, less than 10 hours of previous cognitive training).~     Investigators anticipate that musical engagement will serve as an enjoyable cognitive~     intervention for older adults. Investigators believe that piano training will enhance~     cognitive performance on executive functions essential for maintaining independence in older~     adulthood. Learning a musical instrument, while challenging, will improve self-efficacy,~     mood, and qualtiy of life. Participants engaged in piano training will demonstrate reduced~     cortisol levels and increased immune function responses. Investigators predict that adults~     enrolled in computerized cognitive training will demonstrate enhanced memory, working memory~     and self-efficacy post-training.~   "
76583|NCT02564588|"~     Evaluate the efficacy of flexibly-dosed dasotraline compared with placebo in adults with~     moderate to severe Binge Eating Disorder (BED)~   "
76584|NCT02564575|"~     The purpose of this study is to evaluate the safety, infectivity, and immunogenicity of the~     HPIV3-EbovZ GP Ebola vaccine candidate in healthy adults.~   "
76585|NCT02564562|"~     The study aims to understand, using radiolabelled PF-06463922, how this compound is modified~     by the body once it is absorbed. The study also aims to understand how much of the compound~     is broken down and how much leaves the body unchanged.~   "
76586|NCT02564549|"~     Phase II non-inferiority randomized trial of annual systematic biopsies versus mpMRI and~     targeted biopsies for men with low risk prostate cancer on active surveillance with any~     volume Gleason's Score 6, but no prior MRI imaging of the prostate.~   "
76587|NCT02564536|"~     For the first 28 day cycle, all patients will be treated with single agent pacritinib at 200~     mg twice daily. The investigators chose this starting dose based on the previous three phase~     I studies of pacritinib as a single agent which showed that the maximum tolerated dose (MTD)~     to be 500 mg, and subsequently, the dose of 400 mg daily was recommended for the phase II~     studies.~      Recently, the results of the phase III PERSIST-1 trial comparing pacritinib to best available~     therapy (BAT) in patients with MF was reported at the 2015 American Society of Clinical~     Oncology (ASCO) annual meeting. Pacritinib was found to be significantly more effective than~     BAT at reducing spleen volume at 24 weeks of therapy and improving constitutional symptoms.~      Low dose decitabine has demonstrated depletion of DNMT1 in normal hematopoietic stem cells~     (HSC) without cytotoxicity and subcutaneous (SC) instead of intravenous (IV) administration~     may avoid high peak levels that can cause apoptosis. Furthermore, the low toxicity associated~     with low dose decitabine would allow for more frequent (1 to 3 times weekly) administration~     of the drug which would catch more cells in S-phase via greater exposure time. Based on these~     findings, a starting dose of decitabine 5 mg/m2 SC twice weekly should be well tolerated and~     effective in patients with MF and MPN/MDS syndromes when combined with pacritinib 400 mg~     daily.~   "
76588|NCT02564523|"~     The purpose of this study is to assess the safety, tolerability and immunogenicity of three~     heterologous prime-boost regimens for Ebola vaccines Ad26.ZEBOV and MVA-BN-Filo. The study~     will include healthy adults and elderly participants, HIV infected participants and healthy~     children in 2 age strata.~   "
76589|NCT02564497|"~     The purpose of the study is to compare the Pharmacokinetics (PK) of Process E belatacept~     relative to Process C belatacept in Healthy subjects~   "
76590|NCT02564484|"~     This observational study is designed to establish induced pluripotent stem cells (iPSCs) from~     childhood cancer survivors who did or did not develop persistent treatment-induced peripheral~     neuropathy, from which to make human neurons for comparing their sensitivity to vincristine~     and other potentially neurotoxic drugs.~      Investigators will assess the effects of inherited genome variations on treatment-induced~     peripheral neuropathy that persists in adults who were cured of childhood cancer. Cells from~     childhood cancer survivors who did or did not develop drug-induced neuropathy will be~     isolated and induced to become neurons. Cell sensitivity to anticancer agents will be tested~     in both groups and compared to determine if the survivors have genetic variants that~     correspond to those identified in companion genomic studies. This will assist in determining~     if gene variants increase the risk of treatment-induced neurotoxicity.~      The investigators are interested in detecting changes of phenotype pre-post treatment in each~     group (cases, controls) respectively, as well in comparing the pre-post treatment phenotypic~     changes between the two groups (cases vs. controls).~   "
76591|NCT02564471|"~     This is an exploratory trial to evaluate the effect of antimalarial drugs on the immune~     response generated by rabies vaccine when administered for post-exposure prophylaxis. This~     study will use the FDA approved post-exposure prophylaxis vaccine regimen (without rabies~     immune globulin) in the presence or absence of an FDA-approved malaria chemoprophylaxis~     regimen.~   "
76592|NCT02564458|"~     Purpose: The primary hypothesis of this study is that the combination of interval exercise~     training (IET) as well as motivational accelerometry (MA) delivered both as a 5-12 week~     intervention that will improve cardiorespiratory fitness in patients preparing to undergo~     allogeneic hematopoietic cell transplantation (alloHCT). MA is not an established term, but~     in respect to this study, MA refers to the use of wearable accelerometry paired with regular~     intervals of physical activity coaching from members of the study staff during the IET~     training. The study will also look at several secondary endpoints including the association~     of the intervention with changes in cyclin-dependent kinase inhibitor 2A, multiple tumor~     suppressor 1 (p16INK4a), and the association of the intervention with changes in symptoms and~     quality of life before and after transplant.~      Participants: 60 patients will be randomized into two groups, 30 in the intervention group~     consisting of both IET and MA, and 30 in the control group applying usual care and use of~     wearable accelerometry without motivational physical activity coaching.~      Procedures (methods): Results of this study will inform a randomized, multi-site study of a~     pre-transplant exercise intervention.~   "
76593|NCT02564445|"~     This is a 36-week, three-arm randomized, controlled trial using a team-based model to compare~     two weight loss programs to control. Each intervention will use insights from behavioral~     economics to leverage social incentives and gamification.~   "
76594|NCT02564432|"~     The purpose of this study is to investigate the clinical implementation of a new percutaneous~     prosthetic attachment system by determining the resident microbial ecology of the implant~     exit site and to simultaneously study the systemic and local stomal immune responses. This~     study will follow 10 patients implanted with percutaneous osseointegrated prosthetics (POPs)~     for a period of one year. Two state-of-the-art, pre- and post-surgery bacterial monitoring~     technologies will be used; these procedures are intended to facilitate the early prediction,~     detection, and treatment of infection, as well as to provide follow-up data that can~     potentially be used to advantageously manipulate the stomal microbial environment in future~     clinical trials.~      Commensal skin bacteria colonize all stomas. Colonization does not necessarily result in~     infection. Over time, the presence of this skin penetrating foreign object (implant) will~     cause measurable changes in the bacterial population (microbiota) at and around the POP exit~     site. It is anticipated that the evolving microbiota, in concert with measurable changes in~     the local and systemic cytokine responses, will reveal patterns associated with~     mutualistic-commensal bacteria and/or pathogenic bacteria related to the stages of chronic~     wound healing. These patterns could be used to determine the presence of a stable uninfected~     stoma or the progression of a stomal infection. Hopefully, this information will allow timely~     intervention to prevent infection, i.e. by detecting early stages of infection or discerning~     common patterns of stable mutualistic-commensal bacterial strains, effective intervention~     protocols (antibiotics, probiotics or manipulation of the stomal and skin microbiota) may be~     developed to avoid patient morbidity and assure implant survival.~   "
76595|NCT02564419|"~     In this study, investigators will show proof-of-concept that brain signals can be used in~     real-time, closed-loop mode to trigger stimulation for hand function. Subjects will undergo~     surgery to implant a unilateral subdural strip electrode (Resume II, Model 3587A) over the~     motor cortex. These electrodes implanted in the brain will enable bioelectrical data~     recording (sensing) from the brain to the implanted Activa PC+S. The cortical sensing data~     will be~        1. either processed in the Activa PC+S; or~        2. off-loaded via the Nexus D communication device (Medtronic) to a computer.~   "
76596|NCT02564406|"~     Noninvasive ventilation represents the standard of care for patients with exacerbation of~     chronic obstructive pulmonary disease. However, NIV fails in almost 30% of the most severe~     forms of acute hypercapnic respiratory failure and patients must undergo endotracheal~     intubation and invasive ventilation to restore adequate gas exchange. Under these~     circumstances, patients may express a clear intention not to be intubated.The aim of this~     study is to retrospectively assess efficacy and safety of noninvasive ventilation-~     plus-extracorporeal Co2 removal in patients who fail NIV and refuse endotracheal intubation.~   "
76597|NCT02564393|"~     The study is defined in 3 stages of in vitro assays :~      Phase 1 : Secretion of NETs in response to lung disease and their secretion of factors.~      This is a transversal study in which we compare :~        -  Producing NETs (DNA and proteases ) by neutrophils purified from sputum and blood of~          patients~        -  Producing NETs (DNA and proteases ) by purified neutrophils in the blood of patients and~          blood of control subjects~      Phase 2: Mechanisms of activation of NETs secretory pathways . This phase will identify~     receptors (TLR ) involved in the secretion of NETs and analyze the involvement of dependent~     transduction pathways calcium and PKC . It will be performed on control blood neutrophils.~      Phase 3: Analysis of cell death ( NETose )~      This is a transversal study that will analyze :~      the mode of cell death of neutrophils purified blood and sputum of patients and control blood~     neutrophils by flow cytometry and transmission electron microscopy .~   "
76601|NCT02564341|"~     The TEACH randomized controlled trial will test the effectiveness of a collaborative care~     intervention directed towards physicians who provide care for HIV-infected persons to improve~     the quality of care for prescribing chronic opioid therapy (COT) for pain and reduce the~     misuse of prescription opioids among HIV-infected persons.~   "
76602|NCT02564328|"~     Stroke is a frequently occurring and common diseases in nervous system,and most of the~     survivors will remain disorders of motor,sensory and cognition function.Stem cell~     transplantation provides a promising approach for rehabilitation. The main objective of this~     study is to evaluate the efficacy and safy of the transplantation of autologous bone marrow~     mesenchymal stem cells in patients with chronic stroke.~   "
76603|NCT02564315|"~     Relapse after a serious quit attempt occurs in 70-90% of smokers who try to quit smoking.~     This study utilizes a sequential, multiple assignment, randomized trial (SMART) design - - an~     innovative multi-phase approach - - to test post-relapse treatments designed to assist~     smokers to make a new, successful quit attempt. This study will test Relapse Recovery (RR)~     treatments that are applied at two stages following relapse: 1) RR Preparation Phase~     treatments for smokers who relapse after an initial quit attempt, and 2) RR Cessation Phase~     treatments for relapsed smokers who decide to make a new quit attempt. Smokers motivated to~     quit smoking will make an initial quit attempt in the Quit Phase (cessation medication +~     counseling). Participants who relapse will be randomized to one of three RR Preparation Phase~     treatments (Behavioral [Smoking] Reduction Counseling + the Nicotine Mini-Lozenge; Recycling~     Counseling that encourages participants to quit again as soon as possible; and Preparation~     Phase Control). RR Preparation Phase participants (other than controls) who elect to try a~     new quit attempt will be randomized to one of four RR Cessation Phase treatments based on a~     2X2 fully-crossed factorial design testing two factors: Supportive Counseling (vs. Brief~     Information) and Skill Training (vs. Brief Information). All RR Cessation Phase participants~     will receive 8 weeks of combination nicotine replacement therapy (nicotine patch + nicotine~     mini-lozenge). The investigators hypothesize that RR Preparation Phase Reduction treatment~     will significantly increase long-term abstinence rates relative to the Preparation Phase~     Control condition.~   "
76604|NCT02564302|"~     This study aims to investigate the effect of MUSE (R) Headbands on patients with Atrial~     Fibrillation who is awaiting pulmonary vein isolation ablation procedure. Patients are~     randomized in 2 arms. The control arm will not be receiving the MUSE headband, whereas the~     treatment group obtains a device.~      Patients from both group will fill out a quality-of-life questionnaire at the time of~     enrollment and 3 months post PVI. Results from both arms will be evaluated and ultimately the~     effect of mindfulness using the headband will be evaluated in the aforementioned patient~     population.~   "
76605|NCT02564289|"~     The current study proposes to investigate the effects of chronic snus use on the blood~     vessels. Several cardiovascular endpoints are measured using various methods in healthy daily~     snus users as well as in healthy matched controls.~   "
76606|NCT02564276|"~     To determine the difference in the proportion of hemipelves with successful detection of~     Sentinel Lymph Node according to the dye used (indocyanine green with near-infrared imaging~     vs blue dye) in women with endometrial cancer.~   "
76607|NCT02564263|"~     In this study, participants with advanced or metastatic adenocarcinoma or squamous cell~     carcinoma of the esophagus or Siewert type I adenocarcinoma of the esophagogastric junction~     (EGJ) that has progressed after first-line standard therapy will be randomized to receive~     either single agent pembrolizumab or the Investigator's choice of standard therapy with~     paclitaxel, docetaxel, or irinotecan. The primary study hypothesis is that treatment with~     pembrolizumab will prolong overall survival (OS) as compared to treatment with standard~     therapy.~   "
76608|NCT02564250|"~     The purpose of this study is to study longitudinal changes in maternal metabolism and~     pregnancy outcomes in obese pregnant women.~   "
76609|NCT02564237|"~     This is a single-centered trial of a group A streptococcal (GAS) vaccine, StreptAnova™. The~     study is designed to assess safety and immunogenicity of three doses (0, 1, 6 months) of one~     dosage (600 µg protein) in healthy adults 18 through 50 years of age.~   "
76610|NCT02564224|"~     Temporary stomas has been performed to reduce complications after colorectal cancer surgery,~     especially in high-risk anastomosis. Different closure technics showed different outcome. The~     aim of this study is to compare the VSS score , surgical site infection and pain score of~     pursestring wound closure vs conventional closure.~   "
76611|NCT02564211|"~     This is a study to assess the safety and efficacy of the addition of ipragliflozin to~     sitagliptin in Japanese participants with Type 2 diabetes mellitus (T2DM) who have inadequate~     glycemic control on sitagliptin, diet, and exercise therapy.~   "
76612|NCT02564198|"~     The main purpose of this study is to evaluate the safety of the study drug known as~     ramucirumab in children with recurrent or refractory solid tumors including central nervous~     system (CNS) tumors.~   "
76613|NCT02564185|"~     According to the WHO, therapeutic education is intended to help patients acquire or maintain~     the skills they need to optimally manage living with a chronic disease. Low back pain is~     frequent and therapeutic education could be a promising option.~      The purpose of the study is to evaluate the impact of a therapeutic education program for~     patients suffering from low back pain.~   "
76614|NCT02564172|"~     Pudendal neuralgia is a frequent diagnosis in pain clinics. This perineal pain has~     devastating effects on patient's quality of life. Today, 30% of patients are refractory to~     pain management and surgical procedure.~      The neuropathic characteristics of the pain in these patients lead us to test the efficiency~     of spinal cord stimulation at conus medullaris level.~      In our published preliminary study involving 27 patients with refractory pudendal neuralgia,~     we demonstrated that 74% of patients implanted with stimulation electrodes at the conus~     medullaris responded to stimulation.~      The primary objective of the present trial is to assess through a randomized, parallel group~     design, the effectiveness of spinal cord stimulation at the conus medullaris using pentapolar~     surgical lead ((TM)Penta, St Jude medical ANS) versus medical treatment alone on sitting time~     in refractory pudendal neuralgia.~   "
76652|NCT02563678|"~     In this small pilot study, participants (patients and healthy volunteers) will have blood~     drawn before and after the study intervention (hyperbaric chamber session or normal pressure~     oxygen breathing. This blood will be analyzed for neutrophil oxidative burst and cytokine~     analysis.~   "
76615|NCT02564159|"~     Malnutrition is a major risk factor for morbidity and mortality of patients managed in~     intensive care unit. Early recognition and treatment of adult malnutrition are recommended in~     acute care settings especially for patients requiring mechanical ventilation. Biochemical~     indicators like serum concentrations of albumin and prealbumin (transthyretin) have a~     tradition of being used as markers of nutritional status but remains influenced by~     nonnutritional factors. A recent assessment of quadriceps muscle diameter with ultrasound~     method has gained interest for screening and follow-up of muscle weakness at the bedside in~     critically ill patients. The purpose of the study is to investigate the validity of~     ultrasound as measurement tool for assessing malnutrition acquired in intensive care unit.~   "
76616|NCT02564146|"~     ALPACA is an interventional, multicentre, open-label, randomized active-controlled phase II~     trial with two arms.~      To estimate the treatment effect on overall survival, feasibility, efficacy and safety of~     alternating treatment cycles of gemcitabine monotherapy followed by~     nab-paclitaxel/gemcitabine relative to standard continuing nab-paclitaxel/gemcitabine cycles~     in first-line treatment for metastatic pancreatic cancer in patients having received 3 cycles~     of induction therapy with standard nab-paclitaxel/gemcitabine.~   "
76617|NCT02564133|"~     Ereth et al. showed in 1992, using transesophageal echocardiography, that the implantation of~     a hip prosthesis may be complicated by intracardiac embolization of various origin.~      A patent foramen ovale exists in approximately one fifth of the population; it facilitates~     the passage of embolus from the right heart to the left one and then especially to the~     coronary vessels and to the brain.~      The hypothesis supported in this research is that the prevalence of postoperative~     complications, especially neurological ones, is increased after surgery for hip fracture when~     patients have a patent foramen ovale.~   "
76618|NCT02564120|"~     NC ProCESS is a cohort of patients from diverse backgrounds diagnosed with early prostate~     cancer, who were enrolled from January 2011-June 2013. These patients were recruited~     throughout North Carolina, and also in partnership with institutions across the country.~     Patients enrolled before they start treatment, and are then followed prospectively through~     treatment and then afterwards. This observational study collects information on quality of~     life, cancer control, and health care received inclusive of treatment and management of~     subsequent effects including complications and recurrence. The objective of this study is to~     examine comparative outcomes among different modern prostate cancer treatment options in this~     cohort of patients.~   "
76619|NCT02564107|"~     This study will evaluate the efficacy, safety, and effect on quality of life of oral~     ibandronate (Bondronat) in participants with breast cancer and metastatic bone disease. The~     anticipated time on study treatment is 25 weeks, and the target sample size is 50~     individuals.~   "
76620|NCT02564094|"~     This study will evaluate the efficacy, safety, and pharmacoeconomics of treatment with~     subcutaneous (SC) epoetin beta (NeoRecormon) in participants with hematologic malignancies or~     solid tumors. The anticipated time on study treatment is 20 weeks, and the target sample size~     is 60 individuals.~   "
76621|NCT02564081|"~     Recent research suggests that the skeletal muscles and the fibrous connective tissue form a~     body-wide network of myofascial chains. A systematic analysis of dissection studies suggests~     that fascia links at least a variety of muscles to myofascial chains (Wilke et al. 2015). As~     fascia can modify its stiffness, strain transmission along these meridians is supposable~     (Norton-Old et al. 2013). Tensile transmission along myofascial chains might contribute to~     the proper functioning of the movement system. However, despite solid evidence from in vitro~     studies, scarce data is available concerning the in vivo behavior of the meridians. The~     present study is conducted to resolve this research deficit and to elucidate whether~     stretching of the lower limb muscles increases neck mobility. Healthy subjects (n = 3 x 20)~     participate in the randomized controlled trial. One group performs three 30 s bouts of static~     stretching for the gastrocnemius and the hamstrings respectively. A control group remains~     inactive for the same time. Participants of the third group perform 6x30 s bouts of static~     stretching of the cervical spine in zhe sagittal plane (flexion only). Pre and post~     intervention as well as 5 min after the intervention, maximal cervical range of motion (ROM)~     in flexion/extension, lateral flexion and rotation was assessed using an ultrasonic movement~     analysis system.~   "
76622|NCT02564068|"~     In human volunteers intranasal administration of oxytocin significantly increases~     parasympathetic and decreases sympathetic cardiac control. OSA is a very prevalent disease~     with high cardiovascular risk factors, yet this disease remains very poorly treated. This~     proposal, based on the current literature and new basic science results detailed above on the~     role of oxytocin in cardiovascular control, will test if oxytocin administration improves~     adverse cardiovascular events during the recurrent nocturnal apneas in patients with OSA.~     This project will lay the groundwork and provide preliminary data to obtain NIH funding to~     test this important hypotheses more thoroughly and in larger clinical trials.~      This study will explore if intranasal oxytocin has any positive cardiovascular benefits in~     patients with sleep apnea.~   "
76623|NCT02564055|"~     This study will evaluate the efficacy and safety of two concentrations (0.5 percent [%] and~     1%) and two application frequencies (once a day and twice a day) of GSK2894512 cream for the~     topical treatment in adolescent and adult subjects with atopic dermatitis. Results from this~     study will be considered when selecting the most appropriate concentration of GSK2894512~     cream and application frequency in future clinical studies. This is a multicenter (United~     States, Canada, and Japan), randomized, double-blind (sponsor-unblind), vehicle-controlled,~     6-arm, parallel-group, dose-finding study in adolescent and adult subjects with atopic~     dermatitis. Two concentrations of GSK2894512 cream (0.5% and 1%) and a vehicle control cream~     will be equally randomized and evaluated following application to all atopic dermatitis~     lesions (except on the scalp) once daily (evening) or twice daily (morning and evening) for~     12 weeks. This study will consist of 3 periods: up to 4 weeks screening, 12 weeks~     double-blind treatment, and 4 weeks post-treatment follow-up. The total duration of subject~     participation will be approximately 16 to 20 weeks. Approximately 270 adolescent and adult~     males and females subjects with atopic dermatitis will be screened in order to have at least~     228 randomized subjects (38 subjects for each of the 6 treatment groups) and approximately~     204 evaluable subjects overall. Approximately 30 subjects will be randomized in Japan to~     achieve at least 24 evaluable Japanese subjects.~   "
76624|NCT02564042|"~     This study will evaluate the efficacy and safety of two concentrations (0.5 percent [%] and~     1%) and two application frequencies (once a day and twice a day) of GSK2894512 cream for the~     topical treatment in subjects with plaque psoriasis. Results from this study will be~     considered when selecting the most appropriate concentration of GSK2894512 cream and dosing~     frequency in future clinical safety and efficacy studies. This is a multicenter (United~     States, Canada, and Japan), randomized, double-blind (sponsor-unblind), vehicle-controlled,~     6-arm, parallel-group, dose-finding study. Two concentrations of GSK2894512 cream (0.5% and~     1%) and a vehicle control cream will be equally randomized and evaluated following~     application to all psoriasis lesions (except on the scalp) once daily (evening) or twice~     daily (morning and evening) for 12 weeks. This study will consist of 3 periods: up to 4 weeks~     screening, 12 weeks double-blind treatment, and 4 weeks post-treatment follow-up. The total~     duration of subject participation will be approximately 16 to 20 weeks. Approximately 270~     adult males and females subjects with plaque psoriasis will be screened in order to have at~     least 228 randomized subjects (38 subjects for each of the 6 treatment groups) and~     approximately 204 evaluable subjects overall. Approximately 30 subjects will be randomized in~     Japan to achieve at least 24 evaluable Japanese subjects.~   "
76625|NCT02564029|"~     PF-06372865 in subjects with photosensitive epilepsy~   "
76626|NCT02564016|"~     The goal of this study is to evaluate the effect of continuous postpartum epidural saline~     infusion on the reactivation of labor epidurals for postpartum tubal ligation surgery~     following vaginal delivery.~   "
76627|NCT02564003|"~     The pharmacokinetics of oxycodone is well characterized in children older than six months of~     age. However, only one study has been published with children younger than six months,~     concluding that unexplained inter-individual variability is pronounced in the youngest~     children. The aim of the current study was to quantify oxycodone pharmacokinetics in children~     ranging from preterm newborn infants to children up to two years of age.~   "
76628|NCT02563990|"~     This is a prospective, randomized, single-blinded human clinical trial that will examine how~     injection pressure influences the spread of a given volume of injectate in the adductor~     canal, during adductor canal nerve block.~   "
76629|NCT02563977|"~     The purpose of this study was to perform an evaluation of the structural changes in the~     abdominal wall after harvesting a DIEP flap in breast reconstruction.~      15 women undergoing secondary, unilateral breast reconstruction were recruited to the study~     and underwent a 2 year postoperative CT scan of the abdomen (without contrast).~      Structural changes were assessed by comparing the abdominal CT scans performed prior to~     surgery with the 2 year postoperative CT scans.~   "
76630|NCT02563964|"~     Myocardial infarction (MI) frequently recurs after non-ST elevation MI (NSTEMI) that may be~     related to insufficient vulnerable plaque identification using invasive coronary angiography.~     Furthermore, the natural behaviour of vulnerable plaques in NSTEMI over time and their~     relation with biomarkers need further exploration. More accurate identification and assessing~     long-term behaviour of vulnerable plaques may improve therapeutic strategies and clinical~     outcome. The investigators hypothesize that fully integrated 18Fluoride Sodium-Fluoride~     (18F-NaF) Positron Emission Tomography/Cardiac Magnetic Resonance imaging (PET/CMR) increases~     the ability to detect vulnerable plaques as compared to coronary angiography.~      This prospective study in 33 consecutive patients with NSTEMI aims to:~        1. Compare coronary vulnerable plaque detection between 18F-NaF PET/CMR and invasive~          coronary angiography,~        2. Investigate the correlation of coronary vulnerable plaques using 18F-NaF PET with~          myocardial infarction using CMR, both at baseline and during follow-up,~        3. Examine systemic arterial 18F-NaF-uptake using PET/CMR and their relation with systemic~          events (cerebrovascular accidents, transient ischemic attacks, or peripheral arterial~          disease), and~        4. Examine the relation between vulnerable plaques and plasma biomarkers.~   "
76631|NCT02563951|"~     The purpose of this study is to examine the pharmacokinetics (PK), safety and tolerability of~     3 intranasal (IN) doses (0.5, 1.0 and 2.0 mg) of Granisetron Hydrochloride Nasal Sprays (GNS)~     as compared to Granisetron IV Injection and Granisetron Tablet in healthy Volunteers.~   "
76632|NCT02563938|"~     This first-in-human study will evaluate the safety and tolerability of single doses of AK001~     across a range of potentially active doses. Early signals of pharmacodynamic activity will~     also be evaluated.~   "
76633|NCT02563925|"~     The purpose of this study is to see if the combination of tremelimumab and durvalumab with~     brain radiation therapy can help treat this type of breast cancer that has spread to the~     brain.~   "
76634|NCT02563912|"~     Dosage errors are common in the stressful situation of a pediatric resuscitation. In addition~     to that, studies have reported that delays to provide medication is associated to worst~     survival rate for very sick children. To minimize delays and error, the investigators~     recently published a resuscitation handbook who provides drug dosages for each weight for~     children thus eliminating the need for dosage calculation. Once the weight of the patient is~     known, the physicians only have to open the book at the page corresponding to the weight and~     all the medications with their calculated dosage are provided. The primary goal of this study~     is to evaluate the number of dosage error during simulated pediatric resuscitation comparing~     residents using the handbook vs. utilisation of a chart providing non-calculated dosage. This~     will be an experimental crossover trial among 40 residents performing four simulated~     case-scenarios in a high-fidelity simulation lab.~   "
76635|NCT02563899|"~     This is a double blind (sponsor unblind), repeat dose, randomized, parallel group, placebo~     controlled study to assess the pharmacokinetic parameters, safety, tolerability, and clinical~     effect of topically applied umeclidinium following once daily topical administration to~     axilla for 14 days in subjects with primary axillary hyperhidrosis. This study will determine~     whether topically applied umeclidinium can decrease hyperhidrosis without systemic~     anticholinergic effects (ie. in the range or lower to those obtained after inhaled route) at~     the highest possible concentration.~      Subjects will be dosed by site staff each night immediately before bedtime for 14 days.~     Subjects will complete gravimetric and Hyperhidrosis Disease Severity Scale (HDSS)~     measurements, patient reported outcomes (PRO), safety assessments, and/or pharmacokinetic~     sampling. Follow up visits will occur on days 15, 16, 19, 23 and 28. The total duration of~     the study will be approximately 6 to 8 weeks. The study is planned to enroll approximately 24~     subjects.~   "
76636|NCT02563886|"~     The purpose of this study is to determine whether intensive, focused training of the affected~     upper extremity after stroke results in long-term functional gains in moderately-to-severely~     paralyzed patients, more than 6 months after their vascular accident. During the course of~     therapy, user's attempts to move and complete exercises are assisted by neuromuscular~     electrical stimulation.~   "
76637|NCT02563873|"~     The investigators are examining the relationship between heart rate and heart contraction in~     patients with heart failure and pacemakers, aiming to improve quality of life.~   "
76638|NCT02563860|"~     This is a phase 2 , open label, dose escalating study of Lovastatin in Rett syndrome.~   "
76639|NCT02563847|"~     With this study the investigators investigate the effects of amino acids (tryptophan in two~     different concentrations, leucin) and sugar alcohols (xylitol, erythritol) on satiety~     mechanisms.~   "
76640|NCT02563834|"~     Studies of myocardial fuel selection using a novel palmitate-based PET probe~   "
76641|NCT02563821|"~     Background : Recently, delivery of local anaesthetics via Programmed Intermittent Epidural~     Bolus (PIEB) has been shown to improve labour epidural analgesia compared to delivery via~     Continuous Epidural Infusion (CEI).~      Purpose : However, the superiority of PIEB compared to CEI has not been investigated for~     third trimester voluntary termination of pregnancy.~      We hypothesized that PIEB administration would result in a better degree of satisfaction of~     the patients compared with CEI for third trimester legally induced abortion analgesia.~   "
76642|NCT02563808|"~     The purpose of this study is to investigate the impact of incorporating anticipated regret ~     into standard patient decision aids. Participants in the Wharton Behavioral Lab will be~     administered a standard patient decision aid and an anticipated regret augmented decision~     aid. Participants will complete a computerized survey about their experiences with each~     version, and their answers will be assessed for potential differences associated with the~     incorporation of Anticipated Regret.~   "
76643|NCT02563795|"~     Anesthesia for cesarean section requires special importance because it may affect both mother~     and the baby. To avoid maternal hypotension related to spinal anesthesia must be the primary~     objective during anesthesia. Even though many factors influence sensory nerve block for~     surgical anesthesia, local anesthetic dose is the main determinant. Another factor that~     influence the sensory nerve block is the obesity related to pregnancy. Due to the enlargement~     of epidural venous plexus related to pregnancy, the subarachnoid and epidural space reduces,~     so the local anesthetic requirement also reduces. Many investigators recommend lower dose of~     local anesthetic in obese patients due to reduced requirement There are many studies about~     dose regimens for cesarean anesthesia, but ideal dose have not been found. Investigators have~     designed this study to see the effects of conventional dose (10 mg bupivacaine) vs. low dose~     plus fentanyl (7,5 mg bupivacaine+25 mcg fentanyl) in obese and normal weight pregnant for~     cesarean section. The hypothesis was: the low dose regimen provides surgical anesthesia in~     obese patients while avoiding maternal hypotension.~   "
76644|NCT02563782|"~     To evaluate the safety of 3 regimens of short-term, low-dose systemic IMT as rejection~     prophylaxis prior to and/or following transplant of MA09-hRPE cells.~   "
76645|NCT02563769|"~     The main purpose of this study is to determine if it is safe to use the study drug,~     clavulanic acid, in combination with cocaine. In this study, subjects will receive~     intravenous (i.v.) cocaine and the study drug, clavulanic acid. The safety of clavulanic acid~     is being studied so future studies can be done to find out if this drug is helpful in~     treating cocaine dependence. Currently, there is no available medication treatment for~     cocaine dependence.~   "
76646|NCT02563756|"~     Patients with medial gonarthritis are randomised to a unicompartmental or a total knee~     replacement.~      Primary outcome: Thigh muscle cross sectional area and radiological attenuation measured by~     CT Secondary aims: functional tests, gait analysis, health related quality of life and~     patient related outcome.~   "
76647|NCT02563743|"~     Purpose~      Common mental disorders (CMD:s) are the leading cause of sick-leave spells in Sweden,~     resulting in suffering for the individual and financial costs for the employer as well as for~     society at large. Studies on interventions that address stress and mental ill-health and that~     focus on sick leave and return to work (RTW) show little or no effect of commonly used~     methods such as medication or psychological approaches. Furthermore, these interventions~     often focus on the individual's symptoms without considering their work situation. The~     occupational health services (OHS) has knowledge of the employee's work environment and can~     offer treatment facilitating the employee's RTW and improving the employee's work ability~     while taking into account both the individual and the work situation. The intervention in the~     current study will be performed at the OHS.~      The study aim is two-fold: first, an intervention that addresses both individual and~     workplace related aspects among employees with work-related CMD:s and/or stress related~     symptoms will be evaluated. In particular, the treatment's cost-effectiveness and impact on~     sick leave and mental health will be studied. Secondly, the concerned OHS staff's adherence~     to the intended treatment and associations with the outcome of the intervention will be~     assessed.~   "
76648|NCT02563730|"~     A multicenter, multinational, prospective study to clarify, whether the addition of~     cryobiopsy can avoid surgical lung biopsy in a clinically relevant proportion of patients~     with suspected Idiopathic Interstitial Pneumonia~   "
76649|NCT02563717|"~     Trial purpose: For infants born <28 weeks of age, can initial respiratory resuscitation with~     new system (low imposed work of breathing and prongs) reduce the frequency of delivery room~     intubations compared to standard treatment with T-piece resuscitator system (high imposed~     work of breathing and face mask)?~      Trial summary: This is a randomised controlled trial of delivery room intubation rates~     comparing a new system and T-piece resuscitation system for initial stabilisation of infants~     born <28 weeks.~   "
76650|NCT02563704|"~     The purpose of the study is to evaluate and compare the efficacy of parenteral artesunate~     with three quinine regimens in the treatment of severe malaria in children at the Ebolowa~     Regional Hospital located in the South region of Cameroon~   "
76651|NCT02563691|"~     This is a study that assesses the safety and efficacy of using stereotactic radiotherapy in~     conjunction with hormone therapy for patients with metastatic prostate cancer where there are~     a limited number of metastatic tumours.~   "
76654|NCT02563652|"~     Patients undergoing major surgery are exposed to extensive damage of tissues, which induces~     widespread activation of the inflammatory system, called 'systemic inflammatory response~     syndrome' (SIRS).This activation of the inflammatory system may induce instability of the~     heart and respiration in the postoperative period. The degree of physiologic response to~     postoperative SIRS as well as the degree of postoperative pain differ between patients.~     Therefore, patients undergoing anesthesia and major surgery are treated in a 'post anesthesia~     care unit' (PACU) after end of surgery.Admittance to a PACU is expensive. The time patients~     need to stay in a PACU after major surgery has not been extensively studied, and more~     appropriate tools for prediction of length of stay are needed.~      The main aim of this study is to assess whether clinical observations, inflammatory~     biomarkers or genetic markers may aid in the prediction of physiological instability and/or~     pain after major surgery. Such predictors would help clinicians planning the length of~     PACU-stays.~   "
76655|NCT02563639|"~     Objective of the registry is to assess the use of antithrombotic therapies and adherence to~     guidelines in patients with non-valvular atrial fibrillation.~   "
76656|NCT02563626|"~     International registry gathering patients with angiographically confirmed coronary aneurysm.~   "
76657|NCT02563613|"~     In recent years, Hong Kong is undergoing rapid changes together with macro social and~     economic trends. The increasingly complex and diverse family structure is leading to a major~     concern in the well-being of families, including their health, happiness and harmony (3Hs).~     Family life and health education should be strengthened to meet the increasing needs of~     healthy lifestyle promotion. In light of these concerns, the Happy Family Kitchen Movement~     (HFKM) project, with a focus on FAMILY Holistic Health, will be conducted at territory-wide~     level in Hong Kong. HFKM is a community-based research project to develop, implement and~     evaluate a community-based family intervention program for improving family well-being. It is~     expected that participants of the community-based family interventions will gain knowledge on~     family holistic health and in turn promote a healthy lifestyle for 3Hs.~   "
76658|NCT02563600|"~     Patients on the waiting list for physiotherapy treatment for pelvic floor dysfunction will be~     randomly divided into three groups:~        -  a group that gets a telephone call before their invitation letter is sent.~        -  a group that gets a telephone call after their invitation letter is sent.~        -  a group that does not receive a telephone call.~      The phone call is a brief 5-10 minute call, which will be semi-structured. It will remind the~     patient of their appointment time, it will outline what the treatment involves and highlight~     the potential benefits and drawbacks, and allow the patient to ask questions about the~     treatment.~   "
76659|NCT02563587|"~     The purpose of this study is to determine the efficacy of laughter therapy in children to~     improve postoperative, evaluating the intensity of postoperative pain, anxiety and hospital~     stay.~   "
76660|NCT02563574|"~     This study is being done to learn about the interaction of alcohol consumption and HIV on~     brain function. The proposed study will have two broad objectives. The first is to~     incorporate functional neuroimaging (FMRI) approaches, along with additional Magnetic~     Resonance Spectroscopy (MRS) methods that will enable a delineation in both functional and~     cerebral metabolic disturbances affecting specific functional brain systems that are~     associated with the interaction of ethanol (ETOH) consumption on Human Immunodeficiency Virus~     (HIV)-associated brain dysfunction. Recent data indicate that HIV infected patients with~     heavy ETOH consumption have FMRI abnormalities and exhibit alterations on other neuroimaging~     measures compared to moderate drinkers and people who do not drink at all. The second~     objective is to examine the extent to which reductions in ETOH consumption among heavy~     drinkers with HIV infection result from a motivational intervention. The findings from this~     study will provide important information on how heavy ETOH and HIV interact to affect the~     brain functional responsiveness, and the extent of improvement that might be gained by~     reducing heavy ETOH use.~   "
76661|NCT02563561|"~     This is a Phase 3, randomized, multicenter, multi-arm, placebo-controlled, double-blind study~     of apaziquone in patients with ≤4 non-muscle invasive bladder tumors, ≤3.5 cm in diameter,~     all of which must have been fully resected at TURBT.~      In addition to Screening, patients will undergo an assessment of urothelial carcinoma of the~     bladder via cystoscopy for clinically apparent tumor Ta, G1-G2.~      Following TURBT on Day 1, eligible patients will be randomized to one of three treatment arms~     in a 1:1:1 ratio:~      Arm 1 : One dose of Apaziquone~      Arm 2 : Two Doses of Apaziquone~      Arm 3 : Placebo~      Primary endpoint is to evaluate the Time to Recurrence with either a one instillation of 4 mg~     apaziquone or two instillations of 4 mg apaziquone relative to placebo instillation following~     TURBT in patients with non-muscle invasive bladder cancer (NMIBC) who receive transurethral~     resection bladder tumor (TURBT).~   "
76662|NCT02563548|"~     This is a phase 1b study evaluating a combination of PEGPH20 and pembrolizumab in~     hyaluronan-high (HA-high) subjects with relapsed/refractory Non-Small Cell Lung Cancer~     (NSCLC) and HA-high subjects with relapsed/refractory gastric adenocarcinoma.~   "
76663|NCT02563535|"~     The aim of this study is to evaluate the potential advantage in terms of late lumen loss~     reduction of Litos drug-eluting balloon vs standard percutaneous transluminal angioplasty in~     the treatment of below-the-knee disease in patients with critical limb ischemia.~   "
76664|NCT02563522|"~     This study will assess the safety and efficacy of using gene therapy via intramuscular~     injections of the calf for patients with chronic non-healing foot ulcers.~   "
76665|NCT02563509|"~     Research Goal: To reconstitute the anti-HIV specific immunity system of the AIDS patients, so~     the viruses could not massively replicate when HAART was discontinued, then make HIV~     functional cure possible.~   "
76675|NCT02563379|"~     The goals of our study are to determine a).the association between abnormal circadian BP and~     the development of paroxysmal AF in hypertensive patients, b).at which level of TOD,~     paroxysmal AF episodes are detected in hypertensive subjects, c).if there is any association~     between systolic and/or diastolic BP levels with AF occurrence, d).whether the mean heart~     rate during a 24-hr interval is associated with the development of paroxysmal AF, and finally~     e).examine the relationship between a wide PP and asymptomatic AF episodes in patients with~     HTN.~   "
76916|NCT02560220|"~     A phase- I clinical trial to determine safety and feasibilty of intravenous administration of~     mitomycin C-treated donor peripheral blood mononuclear cells in patients with chronic kidney~     disease stage KDIGO 4 or 5 (i.e. GFR 15-30 mL/min or < 15 mL/min) who receive a kidney~     transplant from a living donor.~   "
76666|NCT02563496|"~     This is a prospective, open-label, multicenter, non-comparative, single arm study of~     pediatric subjects with Plasmodium vivax (P. vivax) malaria, aged 6 months to <16 years of~     age. A total of 60 subjects will be enrolled. Potential subjects who are slide-positive for~     P. vivax will be started by the site on chloroquine (CQ) per local/national guidelines. Sites~     will have up to 48 hours to obtain consent. Once full consent is provided, all subjects will~     be screened and, if eligible, receive Tafenoquine (TQ), given as a single dose on Day 1. All~     study medication should be taken with food. After the treatment period, subjects will attend~     up to 7 follow-up visits through Day 120 (Days 3, 8, 15, 29, 60, 90 and 120). The main cohort~     will consist of subjects aged >=2 years to <16 years with no restriction on gender. Subjects~     will be dosed according to four weight bands. Within the total of 60 enrolled pediatric~     subjects, a second cohort of up to 6 infants aged >=6 months to <2 years (weighing >=5~     kilogram [kg]) will be recruited following completion of a planned first interim analysis. An~     interim analysis will be conducted once sufficient data from 16 subjects is available to~     assess pharmacokinetic (PK) and safety parameters. If needed, a second interim analysis will~     be conducted after a total of 32 subjects have enrolled. The primary objective of this PK~     bridging study is to adequately characterize the systemic TQ exposure in the pediatric~     population.~   "
76667|NCT02563483|"~     This study evaluates the effects of the practice of yoga in combination with compassion~     meditation on the quality of life, attention, vitality and self-compassion of family~     caregivers of patients with Alzheimer's disease.~   "
76668|NCT02563470|"~     In this retrospective registry trial, the investigators sought to assess the incidence and~     predictors of cardiovascular and cerebrovascular complications as well as their derivatives~     (acute coronary syndrome, decompensated heart failure, an episode of atrial fibrillation~     requiring cardiologist consultation, stroke, pulmonary embolism and venous thromboembolism)~     in cohort of patients undergoing head and neck surgery.~   "
76669|NCT02563457|"~     This study will assess the efficacy of periodontal treatment in diabetic patient. Patients~     will be randomized in the periodontal group or in the control group. The control group will~     received a periodontal treatment after the study.~   "
76670|NCT02563444|"~     The investigators want to evaluate the accuracy of an ultrasound fusion guiding system in the~     positioning of a needle (here the accuracy is evaluated with a 22G spinal needle), by~     comparing the path indicated by the ultrasound fusion (virtual line) and the path actually~     obtained on the control CT scan (real line).~      Compared with ultrasound guidance alone or CT scan alone, the results are expected to be more~     accurate, saving time and irradiation (not evaluated here).~   "
76671|NCT02563431|"~     About 70% of hemiplegic patients suffer from hemiplegic shoulder pain after stroke. This~     common occurrence is a cause for concern in the rehabilitation setting as it leads to~     impairment of functional outcomes induced by discomfort and delays in rehabilitation,~     important psycho-emotional repercussions as there is a correlation between upper arm pain and~     depression, a longer hospital stay. Poor management of hemiplegic shoulder pain can~     ultimately give rise to type 1 complex regional pain syndrome (CRPS I). There is no~     consensus on treatment, care pathways or useful devices for positioning acute stroke patients~     in the literature. Our objective is to compare the effectiveness of a new positioning~     procedure of the hemiplegic arm with conventional positioning (pillow and~     shoulder-immobilisation sling) in acute stroke patients.~      Patient's actions are focus in 4 points:~        -  Positioning in bed, wheelchair and standing with specific materials (holds, sling in~          external rotation and abduction)~        -  Be careful of shoulder's coaptation in care and functional activities (toilet, dressing,~          transfers)~        -  A training of the patient and members of family on pathology, risk, use of material~        -  Daily passive mobilisation of the upper member by a therapist.~   "
76672|NCT02563418|"~     The purpose of this study is to know the limits of feasibility of a reliable oculomotor~     record for patient with Huntington's disease.~   "
76673|NCT02563405|"~     Hypertension is one of the most common cardiovascular diseases, which is a major risk factor~     for stroke and cardiovascular events. Accumulated data has shown that target-organ damage is~     related not only to 24-h mean intra-arterial BP, but also to BP variability (BPV) in subjects~     with essential hypertension. There are many studies about the effects of different kinds of~     drugs on blood pressure, but the clinical researches about the impacts of antihypertensive~     drugs on BPV are limited, and the conclusion is still controversial.~      In addition, recent studies found that the occurrence and development of hypertension,~     especially essential hypertension, are closely related with hyperuricemia. Serum UA is an~     independently prognostic indicator for the development of hypertension. Some studies have~     observed the effects of different kinds of antihypertensive drugs on uric acid level in~     hypertensive patients. After adjustment, calcium channel blockers are associated with a lower~     risk of incident gout among people with hypertension. However, the effects of alpha blockers~     on uric acid in plasma are still not very clear.~      Therefore, we performed this study to observe the different effects of alpha blocker and~     calcium channel blocker on blood pressure variability and uric acid level in hypertensive~     patients.~   "
76674|NCT02563392|"~     Hysterectomy is an effective treatment used as a first-line approach for uterine myomas.~     Several others alternatives to hysterectomy have been developed in recent years for women~     wishing to retain their uterus: myomectomy, radiological embolization, focused ultrasound.~      Myomectomy, particularly through minimally invasive surgery, is currently considered the~     conservative treatment of choice for patients wishing to preserve their fertility. However,~     three important issues should be considered: the risk of intra- and postoperative bleeding,~     the risk for recurring myomas, and the preservation of subsequent fertility.~      Preventive uterine artery occlusion can be combined with laparoscopic myomectomy in order to~     avoid bleeding and improve uterine suture. Another expected long-term benefit is the~     improvement of treatment efficacy, leading to less symptoms and myomas recurrence. However,~     the effect of uterine arteries occlusion on the ovarian reserve of women of childbearing age~     has not yet been studied, which limits its clinical application.~   "
76684|NCT02563262|"~     The scientific goal of this experiment is to evaluate the performances of our~     three-dimensional digital model by comparing its prediction computed from underwater data to~     posture observed during real weightlessness during parabolic flight.~   "
76676|NCT02563366|"~     This study is designed to investigate whether allogeneic bone marrow-derived mesenchymal stem~     cells (BM-MSCs) can promote function recovery in patients with poor early graft function~     after kidney transplantation from Chinese Donation after Citizen Death (DCD). DCD kidney~     transplant recipients with poor early graft function (with or without dialysis) post~     transplant are equally randomized into MSCs group or control group. Patients in MSCs group~     are administered MSCs treatment. Allogeneic BM-MSCs (1*10^6/kg) from third party are given~     intravenously for four consecutive doses every week after enrollment. Patients in control~     group receive placebo. Renal allograft function (eGFR), rejection, patient/graft survival and~     severe adverse events up to 12 months post enrollment are monitored.~   "
76677|NCT02563353|"~     Objective:~      This is a randomized controlled trial (RCT) in osteoporosis patients randomized to standard~     parathyroid hormone (PTH) treatment alone or to standard PTH treatment and Whole-body~     vibration (WBV). PTH is an effective but expensive anabolic treatment for osteoporosis. WBV~     stimulates muscles and bones. A combined treatment might have synergistic or additive~     beneficial effects on bone, reducing fracture risk making treatment more effective and~     cost-effective. A beneficial effect on muscles and thereby falls risk of WBV may improve~     fracture risk even further.~      If the results of this pilot study are promising then a strong case can be made for a large~     multi-centre RCT using strong endpoints including fractures and falls.~   "
76678|NCT02563340|"~     This study is designed to investigate the efficacy and safety of allogeneic bone~     marrow-derived mesenchymal stem cells (BM-MSCs) on chronic antibody-mediated rejection (cAMR)~     after kidney transplantation. Chronic AMR is diagnosed according to Banff criteria 2013 based~     on renal graft biopsy and donor specific antibodies (DSA) examination. cAMR patients are~     assigned to MSCs group or control group. Patients in control group are prescribed to current~     desensitization therapy including at least one of the following treatments: plasmapheresis~     (PP), intravenous immunoglobulin (IVIG), rituximab or Bortezomib, depending on individual~     pathological and immunological features (eg. DSA type and titer) of each study subjects.~     Patients in MSCs group receive additional BM-MSCs therapy besides desensitization treatments~     as in control group. Allogeneic BM-MSCs (1*10^6/kg) are intravenously administered every two~     weeks for four consecutive doses. All cAMR patients are followed up for one year. Renal~     function, DSA level, pathological features, patient/graft survival, and severe adverse events~     are monitored during the follow-up period. Immunological features of patients in both groups~     are consecutively examined.~   "
76679|NCT02563327|"~     The Tuberculosis Trials Consortium (TBTC) phase 3 treatment trial, Study 31, will investigate~     the efficacy and safety of daily rifapentine (1200 mg daily) with or without moxifloxacin as~     part of multidrug treatment regimens for drug-sensitive pulmonary TB. The proposed study~     (Study 31 PK/PD) will examine the population pharmacokinetics and pharmacodynamics (PK/PD) of~     high-dose daily rifapentine with and without moxifloxacin given for 17 weeks. Two different~     PK sampling procedures are required for the population PK/PD assessments involving~     rifapentine and moxifloxacin: (1) intensive sampling of 6 samples/participant on one occasion~     plus subsequent sparse sampling for a subset of Study 31 participants who are invited to~     co-enroll in Study 31 PK/PD; and (2) sparse sampling of 2-3 samples/participant for all other~     Study 31 trial participants (these data will be collected as part of the Study 31 treatment~     protocol). Herein, we describe the PK sampling to be conducted among those Study 31~     participants who are co-enrolled to Study 31 PK/PD (n=60). Intensive PK sampling is needed in~     some participants to estimate the population PK model parameters with no bias and~     satisfactory precision (relative standard error < 20%). PK and outcomes data from all~     participants in Study 31 will be merged to build the population PK/PD models to evaluate~     PK/PD parameters. Details regarding these planned analyses are also provided in this Study 31~     PK/PD protocol.~      Primary Objectives:~        1. Characterize the population pharmacokinetics of rifapentine and 25-desacetyl~          rifapentine, using sparse PK data from Study 31 and intensive PK data from Study 31~          PK/PD. Using the population PK model, determine post-hoc Bayesian estimates of~          individual-level PK parameters.~        2. Examine the relationship between rifapentine PK parameters of interest and treatment~          efficacy. PK parameters will include area under the concentration time curve (AUC0-24),~          peak concentration (Cmax), time above the mean inhibitory concentration (MIC), and~          AUC/MIC. The treatment outcome of interest will be time to culture conversion and time~          to treatment failure or relapse.~           Secondary Objectives:~        3. Among the Study 31 participants in the lowest 10% for rifapentine AUC0-24, examine the~          PK/PD effect on culture conversion of sputa after completion of 4 months of daily~          rifapentine therapy.~        4. Examine the relationship between safety outcomes (Grade 3 or higher adverse events) and~          rifapentine PK parameters (AUC0-24, Cmax, AUC0-24/MIC and time above MIC).~        5. Characterize the population PK of moxifloxacin, and then estimate moxifloxacin AUC0-24~          and Cmax when moxifloxacin is administered with rifapentine given at a daily dose of~          1200 mg.~        6. Examine the relationships between moxifloxacin PK and treatment outcomes (as described~          in objective 2 for rifapentine) and moxifloxacin PK and safety (as described in~          objective 4 for rifapentine).~      Design:~      In Study 31 PK/PD, among 60 participants with tuberculosis enrolled in a rifapentine-based~     treatment arm of Study 31, PK data will be collected on two occasions. At TBTC sites that~     have the capacity to perform this activity, participants will have 6 scheduled PK samples per~     participant collected to measure rifapentine (with or without moxifloxacin) concentrations~     over approximately 24 hours. In addition among these 60 participants, 2 to 3 scheduled PK~     samples will be obtained on a second late sampling at > 14 days after the first PK~     sampling.~   "
76680|NCT02563314|"~     Hypoxaemic patients with exacerbations of chronic obstructive pulmonary disease (COPD) are at~     some risk of carbon dioxide (CO2) retention during oxygen therapy. Main mechanism of CO2~     retention is believed to be reversal of preexisting regional hypoxic pulmonary~     vasoconstriction, resulting in a greater dead space. Risk of CO2 retention during mechanical~     ventilation remains controversial. Thus recent study suggested limited risk of CO2 retention~     with controlled oxygen supplementation during mechanical ventilation. Conversely, controlled~     oxygen supplementation might decrease dyspnea and respiratory workload, increase comfort and~     improve both urinary output and renal function.~   "
76681|NCT02563301|"~     Tracheal intubation is more difficult in patients in whom cervical spine immobilisation is~     maintained during tracheal intubation. The McGrath Series 5 videolaryngoscope offers a~     potential solution. The relatively short radius of the blade curvature combined with the~     internal arrangement of optimal components means that the glottis can be seen without the~     need for alignment of the oral, pharyngeal and tracheal axes.~      The investigators propose that the McGrath Series 5 videolaryngoscope will improve the view~     of the larynx in patients with limited neck movements, making intubation quicker, easier and~     possibly safer.~   "
76682|NCT02563288|"~     Patients undergoing intracranial procedures may experience severe hypertension and~     tachycardia due to intracranial hypertension and to increased release of adrenaline.~     Preventing perioperative sympathetic activity is of great importance. A common technique is~     using b-blockers like esmolol, which effectively block perioperative hemodynamic changes~     during intracranial surgery. A2 agonists, like Dexmedetomidine-Dex are now being used as a~     component of a balanced anesthesia during neurosurgical procedures. This study aimed to~     evaluate whether esmolol or dex attenuates perioperative changes in patients undergoing~     elective craniotomy with fast track neuroanesthesia.~   "
76683|NCT02563275|"~     The aim of this project is to investigate whether alterations in sensory-motor performances~     during weightlessness are only of theoretical relevance, or indeed restrict the capacity of~     the participants. To find out, volunteers will monitor a complex realistic process by~     operation of buttons and switches in weightlessness. The task will mimic the control of~     vehicles, research equipment and industrial processes. Effects of weightlessness will be~     separated from effects induced by stress and those of motivation through evaluation of~     cortisol and manipulation of motivation.~   "
76685|NCT02563249|"~     If investigators know that the anticipatory mechanisms involved in precision grip take into~     account the gravity, however it is unclear how they adapt to changes in the gravitational~     level. The objectives of this study are to study and model the movement control and the~     mechanisms underlying learning and adapting to the condition of weightlessness. Specifically,~     i) investigators will determine if a change in the level of gravity is taken into account~     when controlling grip force and ii) investigators will examine the effects of gravity change~     on hand-eye coordination.~   "
76686|NCT02563236|"~     During a space mission the crew has to perform a wide variety of tasks under different~     acceleration conditions. For handling of displays and control items during a mission, the~     astronaut's performance is strong depended on an intuitive usability. Currently investigators~     are exploring and developing different Augmented Reality interfaces for the International~     Standard Payload Rack (ISPR) Biolab that is installed in the International Space Station~     (ISS) module Columbus. Augmented reality (AR) is a live, direct or indirect, view of a~     physical, real-world environment whose elements are augmented by computer-generated sensory~     input such as sound, video, graphics or GPS data. Using AR technologies provides~     user-oriented support for working procedures in development, production, and operating of~     complex technical products and systems. It is conceivable that in future manned missions such~     interfaces will be applied to space operations, where the astronaut will handle virtual~     information that enriches the physical reality. To improve the support for the operational~     ground team and the space crew by performing service and maintenance tasks at the Columbus~     space laboratory Biolab, investigators explore innovative tridimensional (3D) interaction~     techniques that allow an intuitive way to interact with the virtual content. The developed AR~     interfaces for the ISPR Biolab ought to offer support while handling standardize service and~     maintenance procedures. This research is primarily focused on supporting the ground team~     during their work at the engineering model of Biolab that is located in Cologne at the~     Institute of Aerospace Medicine. Applying these interfaces subsequently to space operations~     requires previous exploration regarding the influence of different acceleration conditions~     that ought to be considered at the investigators' current stage of designing and development.~     Thereby one important aspect is focused on the correct placement of virtual user interfaces~     while interacting with it. To explore human adaption of handling and controlling virtual AR~     interfaces, this experiment denotes a usability study that will supply findings about human~     mental workload and sensorimotor coordination while performing the experimentation task under~     different accelerations of gravity. The proposed experiment will supply essential information~     about understanding the adequate quality characteristics concerning placement of virtual~     interfaces in physical reality and identify disturbing factors while applying in hyper-g and~     micro-g conditions.~   "
76687|NCT02563223|"~     In this project, investigators propose to study the jump in different reduced gravity fields~     obtained during parabolic flights profiles but also during increased gravity fields obtained~     during turns of the airplane or during the pull-up phase of the parabola. By means of a~     pneumatic device, an additional pull-down force will be added to the vertical force caused by~     the gravity field. By combining different levels of gravity to different levels of the added~     pull-down force it will be possible to dissociate the respective contribution of the~     otolithic and proprioceptive systems to the anticipatory landing response. To the~     investigators' knowledge, only one study has modified the gravity field during a jump.~     However, these authors did not add a pull-down force and only analyzed the vertical ground~     reaction force.~      A better knowledge of the sensory-motor control of the landing phase of a jump will also~     increase the investigators' understanding of the physiopathology of joint instability.~     Indeed, similarities could be found between the evolution of the motor response due to the~     absence gravity during long-duration space flights and the pathological process of chronic~     ankle and knee instability. The knowledge generated by this study will thus provide~     invaluable information in the context of human performance and rehabilitation.~   "
76688|NCT02563210|"~     In preschool aged children, the most suitable techniques to assess airway obstruction is~     debit interruption technic (Rint) and plethysmographic measure of specific airway resistance~     (sRaw). Even if Rint is easily and routinely performed, it also includes a component of lung~     tissue and chest wall resistance as well as respiratory tissue viscoelasticity. sRaw seems to~     be better for discriminating airway obstruction. These two techniques will be compared in~     terms of concordance in the diagnosis of pulmonary obstruction and bronchodilator response.~   "
76689|NCT02563197|"~     Study should show feasibility of the device for drug delivery into the lung independently of~     the severity of impaired lung function.~   "
76690|NCT02563184|"~     To evaluate the magnitude of the humoral immune responses to quadrivalent vs trivalent~     influenza vaccines in adults between the age of 50 and 64 years with a prior diagnosis of~     GOLD Stage C and D COPD vs. those patients without COPD.~   "
76691|NCT02563171|"~     Our objective in this case-control intervention study, therefore, was to explore the effect~     of nonsurgical periodontal therapy on the GCF levels of vaspin and omentin in patients with~     chronic periodontitis in order to determine the usefulness of vaspin and omentin as a~     diagnostic and prognostic biomarker of periodontal disease.~   "
76692|NCT02563158|"~     The study aims to compare the perioperative and long-term outcomes of liver resection for~     HBV-related HCC with versus without hepatic inflow occlusion.~   "
76693|NCT02563145|"~     The purpose of this study is to determine whether real-time fMRI feedback is effective in the~     treatment of aggressive behavior problems in adolescents with high callous unemotional traits~     when compared to treatment as usual.~   "
76694|NCT02563132|"~     Carbon dioxide insufflation during colonoscopy significantly reduces discomfort (pain,~     bloating and flatulence) after the procedure. So far, it has not been studied in inflammatory~     bowel disease patients. The study was designed to evaluate discomfort after the carbon~     dioxide insufflation colonoscopy in comparison to standard air insufflation colonoscopy.~   "
76695|NCT02563119|"~     Studying obesity and metabolic syndrome attention is focused more and more on gut microbiota.~     In humans and animals, bariatric surgery (mainly gastric bypass surgery) lead to alterations~     of gut microbiota, which seem to be favourable. In this study the investigators aim to~     examine the effect of different bariatric procedures on composition of gut microbiota.~   "
76696|NCT02563106|"~     A Phase 2b Parallel-Group, Double-Blind, Placebo-Controlled, Multicenter Study of SYN-004~     Compared to Placebo for the Prevention of Clostridium difficile Infection (CDI) in~     Hospitalized Patients receiving IV ceftriaxone with a Diagnosis of a Lower Respiratory Tract~     Infection (LRTI).~   "
76707|NCT02562963|"~     Natural killer T (NKT) cells are a unique subset of lymphocytes that present a mixed T-NK~     phenotype. Our hypothesis is that Natural killer T cells may decrease the tumor burden and~     improve overall survival. The purpose of this study is to determine whether Natural killer T~     (NKT) cells are effective and safe in the treatment of patients with unresectable advanced~     solid tumor.~   "
76818|NCT02561520|"~     The purpose of this study is to evaluate the safety and efficacy of autologous Platelet Rich~     Plasma (PRP) and Platelet Poor Plasma (PPP) eye drops four times a day in the treatment of~     ocular graft versus host disease (O-GVHD). In addition to their current medication (except~     autologous serum drops), patients will receive PRP and PPP drops.~   "
76697|NCT02563093|"~     The aim of the study is to evaluate the safety and immunogenicity of the 2015-2016~     formulations of Fluzone Quadrivalent and Fluzone Intradermal Quadrivalent vaccines in adults~     18 to < 65 years of age, and of the 2015-2016 formulations of Fluzone Quadrivalent and~     Fluzone High-Dose vaccines in adults ≥ 65 years of age.~      Primary Objective:~      - To describe the safety of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone~     Intradermal Quadrivalent vaccines in adults 18 to < 65 years of age and the safety of the~     2015-2016 formulations of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65~     years of age.~      Observational Objectives:~        -  To describe the immunogenicity of the 2015-2016 formulations of Fluzone Quadrivalent and~          Fluzone Intradermal Quadrivalent vaccines in adults 18 to < 65 years of age and the~          immunogenicity of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone~          High-Dose vaccines in adults ≥ 65 years of age.~        -  To evaluate the compliance, in terms of immunogenicity, of each study vaccine (Fluzone~          Quadrivalent, Fluzone Intradermal Quadrivalent, and Fluzone High-Dose) in the applicable~          age group with the historical requirements of the Committee for Human Medicinal Products~          (CHMP) Note for Guidance (NfG) Committee for Propriety Medicinal Products (CPMP) - CHMP~          NfG CPMP/BWP/214/96.~   "
76698|NCT02563080|"~     Severe pancreatitis induces more damage in the pancreas and might therefore result reduced~     exocrine function leading to the insufficiency. The aim of this prospective study is to~     investigate development of pancreatic exocrine insufficiency in patients recovering from~     first attack of moderately severe or severe acute pancreatitis.~   "
76699|NCT02563067|"~     This study aims to determine the efficacy and safety of QAW039 (Dose 1 and Dose 2), compared~     with placebo, when added to GINA steps 4 and 5 standard-of- care (SoC) asthma therapy (GINA~     2015) in each of the groups (patients with severe asthma and high eosinophil counts and all~     patients with severe asthma)~   "
76700|NCT02563054|"~     This study will evaluate the efficacy and safety of oral capecitabine (Xeloda) versus~     5-fluorouracil (5-FU), in combination with intravenous (IV) cisplatin, in participants with~     advanced and/or metastatic gastric cancer. The anticipated time on study treatment is at~     least 6 weeks and continued up to disease progression, and the target sample size is 300~     individuals.~   "
76701|NCT02563041|"~     BACKGROUND: Central venous catheters (CVC) are the only option when hemodialysis is needed~     for patients without definitive vascular access. However, CVC use is associated with~     complications such as infection, thrombosis, and dysfunction, leading to higher mortality and~     expenditures. The aim of this study was to compare the effectiveness of 30% trisodium citrate~     (TSC30%) with heparin as CVC lock solution in preventing catheter-related bloodstream~     infections (CRBSI) and dysfunction in hemodialysis patients. METHODS: Randomized,~     double-blind controlled trial comparing the event-free survival of non-tunneled CVC locked~     with heparin or TSC30% in adult hemodialysis patients.~   "
76702|NCT02563028|"~     Spine surgery in the prone position (which involves lying face down) is associated with~     various visual changes, ranging from temporary changes in acuity (or sharpness) to permanent~     blindness. Known risk factors include low blood count (anemia) and long surgical times in the~     prone position under general anesthesia. While blindness is a rare outcome of this surgery,~     it is devastating and incompletely prevented by controlling known risk factors. Thus,~     improved monitoring and detection of visual injury during surgery is necessary. The purpose~     of this study is to determine whether a novel, non-invasive monitoring device can reliably~     record visual responses during spine surgery. The first phase of this study is completed and~     involved patients undergoing microdiscectomy surgery. The second phase of this study involves~     patients undergoing single-level lumbar spine decompression/fusion surgery.~   "
76703|NCT02563015|"~     One in four infants are born with low amounts of vitamin D stored in their body. This study~     is designed to test whether improving vitamin D status quickly after birth helps infants to~     build muscle and to normalize growth. This is important since the investigators have noticed~     in previous work that infants with low vitamin D have higher body weight relative to body~     length later on and that those who develop very good stores quickly have a leaner body type.~     Therefore, in this study infants with low stores early after birth will be given either the~     regular amount of supplementation or a higher amount to more rapidly build up the vitamin~     stores in the body. Infants in both groups will be measured for muscle and fat mass at~     standardized ages during the first year of life and into the toddler years. The information~     will inform health care professionals and parents of the importance of establishing good~     vitamin D stores early in life. Vitamin D supplementation is a modifiable factor that is~     already recommended for all term born infants. Knowing how much is needed in infants born~     with low stores has not been tested in a controlled manner in Canada.~   "
76704|NCT02563002|"~     In this study, participants with MSI-H or dMMR advanced colorectal carcinoma will be randomly~     assigned to receive either pembrolizumab or the Investigator's choice of 1 of 6 standard of~     care (SOC) chemotherapy regimens for the treatment of advanced colorectal carcinoma. The~     primary study hypothesis is that pembrolizumab will prolong progression-free survival (PFS)~     or overall survival (OS) compared to current SOC chemotherapy.~   "
76705|NCT02562989|"~     The purpose of this 2-part open-label study is to investigate the safety and efficacy of~     [18F]MK-6240 as a Positron Emission Tomography (PET) imaging agent for quantifying brain~     burden of neurofibrillary tangle (NFT) pathology. Brain NFT deposition is a pathology finding~     in Alzheimer's Disease (AD), and density of brain NFTs has been shown to correlate with~     severity of cognitive impairment in AD. The objectives of the study include performing the~     following with respect to [18F]MK-6240 administered as a PET imaging agent: assess safety and~     tolerability; determine radiation safety profile; determine optimal imaging protocol~     parameters for quantification of brain NFTs in AD; compare tracer binding in brain PET scans~     from participants with AD of varying severity, participants with amnestic mild cognitive~     impairment (MCI) and healthy elderly participants; and evaluate intra-subject test-retest~     (T-RT) variability of tracer uptake in brain regions of interest. The primary efficacy~     hypothesis is that the intra-subject T-RT variability in brain regions associated with NFT~     deposition in AD is ≤10%.~   "
76706|NCT02562976|"~     The aim of the present study was to evaluate characteristics of background mucosa in early~     gastric cancer (EGC), and to seek for the optimal assessment for EGC screening.~   "
88356|NCT02410603|"~     The purpose of this study is to explore the detection of circulating tumor DNA, soluble~     immune markers, and the evaluation of peripheral blood mononuclear cells (PBMC).~   "
76708|NCT02562950|"~     This will be a drug-drug interaction study to evaluate the effect of multiple oral doses of~     GLPG1837 on the single dose pharmacokinetic profile of midazolam administered in fed healthy~     male subjects. Each subject will receive a single oral dose of midazolam (2 mg) on 2~     occasions: on Day 1, before dosing with GLPG1837 and on Day 12 co-administered with GLPG1837,~     after multiple oral doses of GLPG1837 (daily for 10 days, from Day 2 until Day 11).~      Also, the safety and tolerability of multiple oral doses of GLPG1837 co-administered with~     midazolam in healthy male subjects will be evaluated.~      A first dose group of 12 subjects will receive a total daily dose of 500 mg (250 mg b.i.d.)~     GLPG1837 and a second dose group of 12 subjects will receive a total daily dose of 1000 mg~     (500 mg b.i.d.) GLPG1837.~   "
76709|NCT02562937|"~     The primary purpose of the current study was to determine whether a text message intervention~     would increase break frequency and length of break from sitting, time spent standing, and~     time spent in light and moderate intensity physical activity in university students~   "
76710|NCT02562924|"~     This study will assess the effectiveness of MEDIHONEY® sinus rinses (alone or in combination~     with intranasal corticosteroids) vs. intranasal corticosteroid sinus rinses on mucosal~     healing and polyp recurrence in the post-operative period following functional endoscopic~     sinus surgery.~   "
76711|NCT02562911|"~     In the general population, age of puberty, and age of menarche in girls, are closely~     correlated with those of their mother. The severity of chronic disease has an impact on the~     stature, the weight gain and the onset of puberty: age of menarche is even later that chronic~     illness is serious. Cystic fibrosis is one of the major chronic diseases of children.~      Neonatal screening is organized since 2002, most girls with cystic fibrosis therefore~     currently have a very specialized and early care. Older patients were diagnosed during~     childhood. The optimization of the nutritional and respiratory management has allowed over~     the past two decades a significant improvement in the survival of these patients. Most young~     people reach adulthood, puberty and reproductive desire are a crucial issue in the care of~     these young adults.~      In literature, it is often noted an age of menarche delayed an average of 2 years compared to~     the general population, but correlated with the age of menstruation from the mothers.~      The factors involved in the conduct of cycles in the girl followed for cystic fibrosis are~     poorly known and there are few data on the characteristics of cycles. The menstrual~     irregularity and amenorrhoea episodes concern nearly half of women.~      On the pathophysiological level, studies in animals show that there is a direct effect of~     CFTR (Cystic Fibrosis Transmembrane Regulator) on the hypothalamic pituitary gonadal and~     reproductive capacity in mice.~      The literature data on the pubertal development, fertility and hormonal profile of these~     girls are for studies with low numbers and are very old. There is to date no French cohort~     study on this topic.~      The study is a multicenter cross-sectional descriptive study for pubertal and gynecological~     characteristics in girls followed annually in the reference centers Cystic Fibrosis two~     inter-region.~   "
76712|NCT02562898|"~     Gemcitabine and nab-paclitaxel is a standard regimen (NCCN, Category 1) for patients with~     metastatic pancreatic ductal adenocarcinoma (PDAC). However, further improvement in treatment~     is needed. Increasingly, the nature of the immune infiltrate in PDAC appears to be tumor~     promoting. In preclinical studies, ibrutinib treatment, presumably by reprogramming B cells,~     results in increased CD8+ T cells to assist in tumor control. Preclinical studies of~     ibrutinib plus gemcitabine show superior antitumor effects compared to gemcitabine alone in~     both orthotopic murine pancreatic cancer cell line grafts and in genetically engineered mouse~     models. Thus, the investigators propose a clinical trial of ibrutinib plus the standard~     gemcitabine based regimen of gemcitabine and nab-paclitaxel, evaluating safety, then efficacy~     and including correlative studies.~   "
76713|NCT02562885|"~     Background: Close relationship exists between sleep slow wave (SSW) and the generation of~     spike wave in NREM-sleep. SSW are cortically generated oscillations alternating between~     excitatory depolarization (Up-phase of the SSW) and inhibitory hyperpolarization~     (Down-phase of the SSW). It has been shown experimentally that with increasing synchrony of~     slow neuronal oscillations SSW turn into spike waves. Acoustic pulses applied in~     correspondence to the SSW Up-phase enhance the amplitude of the subsequent SSW. Conversely,~     tones delivered at the SSW Downphase have a disruptive effect on the following SSW.~      Participants: Patients with epilepsy and spike waves in NREM-sleep.~      Objective: Modification of spike wave frequency, amplitude and spreading during NREM sleep by~     acoustic pulses applied at the Up- or Down-phase of SSW.~   "
76714|NCT02562872|"~     The study is a single centre, randomised, placebo-controlled, double-blind study with DSM265~     including up to two cohorts of healthy male and female volunteers aged 18 to 45 years.~      The study will be conducted into two sequential parts (Cohort 1 and Cohorts 2a and 2b).~   "
76715|NCT02562859|"~     The purpose of the study is to evaluate the amount of GLPG1837 and metabolite present in the~     blood (relative bioavailability) after a single oral administration of 500 mg GLPG1837 given~     as an oral suspension under fasted conditions as well as a tablet formulation under fasted~     and fed conditions, in male healthy subjects.~      Also, the safety and tolerability of a single oral dose of 500 mg GLPG1837 given as an oral~     suspension under fasted conditions as well as a tablet formulation under fasted and fed~     conditions, will be assessed.~      Twelve subjects will receive GLPG1837 on 3 occasions as single dose administrations: as an~     oral suspension fasted, as an oral tablet, fed and fasted. Treatment administrations will be~     separated by a wash-out period of at least 6 days.~   "
76716|NCT02562846|"~     It has been convincingly demonstrated that electroconvulsive therapy (ECT) works better and~     sooner than antidepressants in the treatment of certain subtypes of depression. Given this~     effectiveness, it would be unfortunate not to give ECT to patients with good response chances~     as this could substantially shorten the length of a severe depressive episode. Instead of~     going through all possible psychopharmacological treatment steps, ECT could be proposed much~     earlier as a treatment option for those patients who might have good response chances. This~     would be a great advantage for the severely depressed patient, with a decreased~     disease-burden and hospitalization duration.~      However, up to now, objective and reliable predictive factors for good ECT response have not~     yet been established. Clinical characteristics such as psychomotor retardation, psychotic~     features and age have often been used to predict the outcome of ECT, but there is too little~     evidence to consider these as strong predictive factors.~      The current project is designed to allow better prediction of ECT-response. The investgators~     base their selection of predictors on clinical impression and previous research results. The~     predictive capacity of psychomotor functioning, psychotic symptoms and several biomarkers~     will be investigated. With these clinical and biological patient and depression~     characteristics, the investigators aim to develop a decision making tool that will allow a~     more accurate indication of ECT.~      The investigators also investigate ways to predict whether or not a patient will have a good~     response when treatment has already started, based on an early improvement of psychomotor~     functioning.~      Another subject of great importance is predicting and preventing side-effects. When patients~     at risk for lasting cognitive side-effects can be identified early in the treatment course,~     treatment can be adjusted to prevent persistence of memory problems. Therefore, the second~     part of the study focuses on identifying people at risk for cognitive side effects early in~     the treatment course.~   "
76717|NCT02562833|"~     The PLE²NO (in Portuguese Education and Exercise Free Program for osteoarthritis) is a~     self-management and exercise program specific for elderly with knee osteoarthritis (OA), with~     the goals of managing OA symptoms, improving physical fitness, and developing self-efficacy~     and self-management of pathology.~   "
76718|NCT02562820|"~     Rett Syndrome (RTT) is a complex disorder resulting from mutations in a gene encoding the~     MeCP2 protein. Currently, there are no methods to fix the abnormal gene, however, animal~     studies suggest that the symptoms of RTT can be treated.~      Ketamine is a sedative or anesthetic, depending on the dose. The drug is approved by the US~     Food and Drug Administration (FDA) and is commonly used in children and adults. Animal~     studies and case reports in humans suggest that ketamine may reduce the symptoms of Rett~     syndrome. The purpose of this study is to determine the safety and efficacy of ketamine for~     treating breathing and behavioral symptoms of RTT.~   "
76719|NCT02562807|"~     The purpose of this study is to evaluate pharmacological effect, safety and pharmacokinetic~     of TAS-303 in female patients with Stress Urinary Incontinence.~   "
76720|NCT02562794|"~     This study will use CBPR mixed methods (qualitative and quantitative data collection) to~     conduct needs assessments and design and evaluate a core family-based intervention. Project~     activities will emphasize capacity building in two refugee communities resettled in Greater~     Boston—the Somali Bantu and the Bhutanese—actively engaging refugee community members,~     community advisory boards, services providers, and other stakeholders. Specific Aims are to:~     (1) deepen partnerships with the Somali Bantu and Bhutanese communities through~     co-leadership, capacity-building, and knowledge sharing; (2) collect and apply qualitative~     data to (a) prepare a needs assessment of mental health in children and adolescents, barriers~     to care, and services preferences with each target refugee group; (b) develop mental~     health/psychosocial assessments for refugee caregivers and children; (c) adapt the core~     components of a family-based strengthening intervention for use with refugees; and (3)~     conduct an 80-family pilot study to examine acceptability and sustainability of the~     intervention. Key outcomes will be reduced mental health symptoms among children and~     adolescents and improvement in caregiver-child relationships.~   "
76721|NCT02562781|"~     Patients undergoing vascular surgery are at a significantly high risk of perioperative~     cardiovascular, cerebral and renal events compared to those undergoing non-vascular surgery.~     This could be because of co-morbidities that are common in this patient group. Additionally,~     smoking, which is common in this population, may be a contributing factor.~      Oxygen therapy has been used for decades in order to reduce the risk of myocardial infarction~     and stroke in patients undergoing vascular surgery and pre-existing co-morbidities in the~     belief that increased inspired oxygen increases oxygen delivery to tissues, thereby reducing~     the risk for hypoxia and cell death. However, several studies published recently have~     questioned the routine use of high inspired oxygen concentration (hyperoxia) to improve~     oxygen delivery, specifically in the neonatal period but possibly even following myocardial~     infarction. This could be explained by the fact that increasing inspired concentrations of~     oxygen cause vasoconstriction in cerebral and coronary arteries, thereby reducing blood flow.~     Additionally, increased oxygen causes excessive production of reactive oxygen species (ROS),~     and repercussion injury from oxidative stress. The latter can lead to apoptosis (cell death)~     in myocardial or cerebral neurons. Despite the high risks of administering oxygen when not~     needed, it is routinely used in hospitals all over the world without a doctors prescription.~      This study aims to assess peri-operative complications up to 1 year following vascular~     surgery in patients randomised to receive high inspired oxygen concentration (endpoint: SpO2~     98 - 100%) or minimal inspired O2 concentration (endpoint: SpO2 > 90%).~   "
76722|NCT02562768|"~     This two-part study will evaluate how safe LY3154207 is and the effects it has on the body.~      Part A will include healthy participants. Each participant will receive daily doses of~     LY3154207 or placebo for 14 days. Part A will last approximately 4 weeks including a 17 day~     stay in the clinical research unit (CRU) and follow-up.~      Part B is contingent on the results of Part A. Part B will include participants with~     Parkinson's disease. Each participant will receive daily doses of LY3154207 or placebo for 14~     days. Part B will last approximately 4 weeks including a 17 day stay in the CRU and~     follow-up.~      Both Part A and Part B will require screening within 30 days prior to the start of the study.~   "
76723|NCT02562755|"~     This is a randomized Phase 3 study to determine whether treatment with vaccinia virus based~     immunotherapy (Pexa-Vec) followed by sorafenib increases survival compared to treatment with~     sorafenib in patients with advanced hepatocellular carcinoma who have not received prior~     systemic therapy.~   "
76724|NCT02562742|"~     This use-results post-marketing surveillance (PMS) study for Sovaldi® tablets (sofosbuvir,~     SOF) administered in combination with Rebetol® capsules (ribavirin, REB) will evaluate the~     safety and efficacy of SOF administered in combination with ribavirin under real world use in~     Japan. Among adult patients with chronic genotype 2 hepatitis C virus (HCV) infection and~     treated with SOF+ribavirin in routine clinical use, the primary objective of this study is to~     evaluate the incidence of adverse drug reactions (ADRs) under real world settings.~   "
76725|NCT02562729|"~     The purpose of this study is to evaluate the feasibility of complete nerve-sparing type C1~     radical hysterectomy in cervical cancer.~   "
76726|NCT02562716|"~     This randomized phase II trial studies how well fluorouracil, irinotecan hydrochloride, and~     oxaliplatin (combination chemotherapy) works and compares to gemcitabine hydrochloride and~     paclitaxel albumin-stabilized nanoparticle formulation before surgery in treating patients~     with pancreatic cancer that can be removed by surgery. Drugs used in chemotherapy, such as~     fluorouracil, irinotecan hydrochloride, oxaliplatin, gemcitabine hydrochloride, and~     paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the~     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill~     more tumor cells. It is not yet known whether combination chemotherapy is more effective than~     gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation before~     surgery in treating pancreatic cancer.~   "
76727|NCT02562703|"~     This is a phase II, randomized, sham controlled, clinical trial. This clinical trial has as~     primary objective to evaluate changes in depressive symptoms of a transcutaneous Vagus Nerve~     Stimulation (tVNS) treatment protocol for patients with moderate / severe depressive episode.~   "
76728|NCT02562690|"~     Impaired thrombotic status is associated with adverse cardiovascular events. Patients with~     acute coronary syndrome (ACS) are at increased cardiovascular risk. The aim of the study is~     to determine the usefulness of thrombotic status assessment in a large cohort of ACS~     patients, managed with contemporary treatments, to identify patients at risk of thrombosis~     and those at risk of bleeding complications.~   "
76730|NCT02562664|"~     Polycystic ovary syndrome (PCOS) is the most common Female endocrine disorder , with a~     prevalence ranging between 6% to10% based on the National Institutes of Health (NIH) criteria~     and when the broader Rotterdam criteria are applied it reaches as high as 15%. Typically,~     PCOS can identify during the early adolescence. Insulin resistance is a common finding in the~     obese women with PCOS. It is most prevalent and severe in PCOS phenotype involving~     hyperandrogenism and chronic anovulation. Women with PCOS who have regular cycles are~     metabolically less abnormal. Acanthosis nigricans (AN) is a dermatosis characterized by~     velvety, papillomatous, brownish-black, hyperkeratotic plaques, typically of the~     intertriginous surfaces and neck. Although AN is associated with malignancy, the recognition~     of its more common connection to obesity and insulin resistance allows for diagnosis of~     related disorders including type 2 diabetes, the metabolic syndrome, and polycystic ovary~     syndrome. Significant improvements in ovulation and pregnancy rates as a result of clomiphene~     treatment after metformin in women with clomiphene-resistant PCOS were reported in a popular~     randomized, double-blind, placebo-controlled trial . The first pharmacological approach to~     induction of ovulation in women with PCOS is clomiphene citrate~   "
76731|NCT02562651|"~     The purpose of the study is to investigate the changes of myocardial biomechanics and~     efficacy of doxycycline in patients with primary anterior STEMI.~   "
76732|NCT02562638|"~     Traditionally, patients are kept nil-per-os (NPO) or nil-by-mouth (NBM) prior to invasive~     cardiac procedures. There exists neither clear evidence nor guidance about the benefits of~     this.~      The investigators aim to assess if there is a reduced incidence of vasovagal complications~     (primary outcome) and the combined incidence of aspiration pneumonia, change in eGFR,~     participant satisfaction if participants are not kept fasting.~      This (pilot) randomised control trial will have an intervention arm allowing participants to~     drink clear liquids freely up to 1 hour before the procedure versus keeping them~     traditionally NPO.~      240 patients will be randomised with 120 participants in each arm.~   "
76733|NCT02562625|"~     Around 13,000 participants are diagnosed with melanoma in the UK each year and that number is~     growing quicker than any other cancer. About 20% of participants will see their cancer return~     following their initial treatment and at present would survive a median time of 912 months.~     In recent years, the development of new effective drugs has revolutionised the treatment of~     advanced melanoma, However, response rates are still low and new therapeutic approaches are~     needed.~      This is a phase II study to look at the effectiveness and safety of the combination of a new~     drug called pembrolizumab plus radiotherapy compared to pembrolizumab alone. The purpose of~     this study is to see if the addition of radiotherapy to pembrolizumab is better than~     pembrolizumab alone by measuring how long these treatments can control the growth of the~     cancer. Also it will assess if by adding radiotherapy the investigators can see its effects~     not only in the tumour that has had radiotherapy but also in other tumours in the rest of the~     body.~   "
76734|NCT02562612|"~     The purpose of this study is to collect response and pharmacokinetic data on the oral~     administration of a cocktail combination of 4 drugs being developed for the indication of~     metastatic breast cancer.~   "
76735|NCT02562599|"~     The purpose of this study is to evaluate the efficacy and safety of raltitrexed and cisplatin~     neoadjuvant chemotherapy followed by concurrent radiotherapy with raltitrexed and cisplatin~     in patients with locally advanced nasopharyngeal carcinoma.~   "
76736|NCT02562586|"~     The goal of this study was to compare early results of Total Hip Replacement (THR) in 2~     groups of patients: with and without closed suction drainage (CSD). Patients were followed~     for 3 months post operatively.~   "
76737|NCT02562573|"~     This is a Phase 2, open-label, single-arm study of the safety and tolerability of PBI-4050~     800 mg daily oral administration in type 2 diabetes patients with metabolic syndrome.~      A total of 12 patients will initially be enrolled for study participation. A Data Safety~     Monitoring Board (DSMB) will continuously review data obtained from the 12 patients. When the~     12 patients have completed at least one month of study treatment, the DSMB will meet and~     determine whether additional patients may be enrolled or the study should be stopped. If the~     safety is deemed acceptable to continue with the study, the study will enroll a maximum of 36~     patients.~   "
76738|NCT02562560|"~     The purpose of this study is to establish a diagnosis in transient global amnesia (TGA) in~     assessing three episodic memory's abilities (mental simulation throught the future, and the~     past, the learning of personnal actions i-e the enactment effect). Secondary goal is to~     describe the neuronal substrates associated to the alteration of theses abilites in TGA.~   "
76739|NCT02562547|"~     This is a retrospective data-only study following the phased introduction of the HEM-AVERT®~     Perianal Stabilizer into routine clinical practice. The investigators aim to capitalize on~     the introduction of the HEM-AVERT® Perianal Stabilizer into routine clinical practice in~     labor and delivery settings in the hospital of Dignity Health - St. Rose, Siena Campus and to~     determine whether the HEM-AVERT® Perianal Stabilizer reduces the frequency of Cesarean~     Section during labor and delivery.~   "
76740|NCT02562534|"~     The aim is to create a database including recordings of ECG data recorded in an MRI~     acquisition~   "
76741|NCT02562521|"~     The purpose of this study is to evaluate a smoking cessation program for employees at the~     Yale University dining hall. Two pilot dining halls and six paired dining halls (3 test and 3~     control sites) will be offered a contingency management/pharmacotherapy smoking cessation~     intervention at the work site.~   "
76742|NCT02562508|"~     This is a bridging trial of the recombinant HPV 16/18 bivalent vaccine manufactured by Xiamen~     Innovax Biotech CO., LTD.The primary objective of this study is to evaluate the~     immunogenicity (type specific IgG antibody) and safety of the tested vaccine administered in~     girls aged 9-17 years is non-inferior to young healthy adults of 18-26 years according to the~     standard 3-dose schedule (0,1,6 months). Meanwhile, this study tries to compare the~     difference of safety and immunogenicity among different schedules (0-6m vs 0-1-6m).~   "
76819|NCT02561507|"~     This is a survey of members of the American College of Surgeons (ACS), to describe and~     explore current patterns of their decisions about withholding or continuation for patients~     taking aspirin (ASA) in the perioperative period. Secondarily, the survey will also explore~     surgeons' knowledge about the risks and benefits attending this decision, and about national~     organizations' recommendations.~   "
76743|NCT02562495|"~     Intensive care unit acquired muscle weakness (ICUAW) is a common disease. After 7 days of~     mechanical ventilation, a quarter of patients develop an ICUAW responsible of a 15-20% of~     muscle loss. This is a serious pathology associated with high morbidity and mortality.~      Clinical diagnosis of ICUAW is difficult and need a patient awoken. CT scan and Magnetic~     Resonance Imaging (MRI) are considered as gold standards to quantify and monitor changes in~     muscle mass. But these tools are not adapted to ICU patients.~      Ultrasound (US) is an easy access tool at the bedside to assess muscle mass and does not~     expose the patient to additional radiation.~      The objective of this study is to evaluate the correlation between US and CT scan to measure~     quadriceps muscle thickness of ICU patients.~   "
76744|NCT02562482|"~     This is a multicenter, randomized, placebo-controlled, double-blind study to evaluate the~     safety and immunogenicity of a 2 injection vaccine Chikungunya virus (CHIKV) and virus like~     particle vaccine (CHIKV VLP) in healthy adults.~   "
76745|NCT02562469|"~     A preliminary clinical trial of ACTIVATE will be conducted in a sample of children with ADHD.~     ACTIVATE is a computerized neurocognitive training program (ACTIVATE; see:~     www.c8sciences.com) that simultaneously targets eight core neurocognitive factors (i.e.,~     sustained attention, working memory (WM), response inhibition, speed of information~     processing, cognitive flexibility and control, multiple simultaneous attention, category~     formation, and pattern recognition and inductive thinking).~   "
76746|NCT02562456|"~     The aim of this randomized clinical trial study is to compare the longevity of ART using high~     viscosity GIC and conventional treatment using composite resin in posterior primary teeth. As~     secondary outcomes, cost-efficacy and patient's self-reported discomfort will also be tested.~     Children aging between 3 to 6 years old presenting at least one occlusal and/or~     occlusal-proximal cavity will be randomly assigned in two groups according to the dental~     treatment - ART with high viscosity GIC (experimental group) or composite resin restoration~     (control group) -, which will be performed at dental care trailer located in a Educational~     Complex in Barueri/SP, Brazil. The unit of analysis for randomization will be the child. A~     number of 240 teeth presenting occlusal cavities and 188 teeth presenting occlusal-proximal~     cavities were set after sample size calculation. The groups will still be stratified~     according to children's caries experience. The primary outcome will be the restorations'~     longevity, which will be assessed after 6, 12, 18 and 24 months by two examiners through~     clinical examination of treatment according to Frencken and Holmgren (2001) criteria for~     occlusal cavities and Roeleveld et al. (2006) criteria for occlusal-proximal ones. The time~     spent during the dental treatment and all materials used will be considered for estimating~     the cost-efficacy of each treatment. The individual's discomfort will be also measured after~     each dental procedure using the Facial Scale of Wong-Baker.~   "
76747|NCT02562443|"~     The study's primary objective [in a population of patients with MDS after failure of~     treatment with azacitidine (AZA) or decitabine (DAC)], is to compare the overall survival~     (OS) of patients in the rigosertib group vs the Physician's Choice group, in all patients and~     in a subgroup of patients with IPSS-R very high risk.~   "
76748|NCT02562430|"~     In summary, the proposed research is novel with respect to design, technology, and its~     multi-level integration probing psychological and neurobiological constructs assumed to be~     crucially implicated in placebo response and has significant clinical and research~     implications for the future. Specifically, the future implications include: 1) identification~     of biomarkers and biosignatures of placebo responders, 2) new possibilities to understanding~     and manipulating the system, 3) possibly decreasing or eliminating a major confounder in~     clinical trials and drug development, and 4) refining treatments with novel drugs that~     decrease (in clinical trial) or increase (in clinical practice) the placebo response.~   "
76749|NCT02562417|"~     Sugammadex is used as a reversal drug for rocuronium- or vecuronium-induced neuromuscular~     block during general anaesthesia. IV dexamethasone is injected as a prophylactic measure~     against postoperative nausea and vomiting. Recent animal data have shown that dexamethasone~     may impair the reversal effect of sugammadex. The objective of this randomised controlled~     trial is to confirm in the clinical practice these preliminary results.~   "
76750|NCT02562404|"~     This study is an observational study designed to determine the extent of gastrointestinal~     (GI) post-procedure complications after Radiofrequency Catheter Ablation (RFCA) for atrial~     fibrillation (AF). This exploratory study will evaluate patient symptoms prior to the RFCA~     procedure, at 1 month post RFCA procedure, and at 3 months post RFCA procedure, through the~     administration of a questionnaire. The purpose of this study is to determine if vagus nerve~     injury resulting from RFCA for AF increases the risk of post-procedure GI complications that~     may present as temporary or permanent symptoms.~   "
76751|NCT02562391|"~     The aim of this study is to assess the effect of left atrial appendage excision on atrial~     fibrillation recurrence and incidence of stroke in patients with persistent and long-standing~     persistent atrial fibrillation undergoing surgical ablation.~   "
76752|NCT02562378|"~     The primary goal is to determine the maximum tolerated dose (MTD) of the combination of T-DM1~     and non-pegylated liposomal doxorubicin in metastatic breast cancer (mBC) patients previously~     treated with taxanes and trastuzumab-based therapy.~      In addition, pharmacokinetic data on the combination of T-DM1 and lyposomal doxorubicin will~     be obtained.~   "
76753|NCT02562365|"~     Ovarian cancer was mostly diagnosed at late stage (III/IV) with high rate of recurrence after~     first line of therapy by optimal cytoreductive sugery and 6-8cycle of TP chemotherapy. We~     developed an adjuvant chemotherapy of three steps (ACTS). It is adding CTX+VP-16(second~     step)6cycle and CTX+CBP(third steps) to firstline chemotherapy (first step). The aim of this~     study is to verify the effectivity and safety of ACTS.~   "
76780|NCT02562014|"~     The excess production of colonic short-chain-fatty-acids (SCFA) has been implicated in the~     promotion of obesity, but colonic fermentation of dietary-fiber to SCFA may also play a role~     in preventing diabetes. The investigators aimed to compare the effects of two fermentable~     fibers (inulin and resistant-starch) on postprandial SCFA, glucose, insulin, free-fatty acids~     (FFA) and gut hormone responses and to compare the responses in healthy overweight and obese~     (OWO) vs lean (LN) participants. Methods: Using a randomized, single blind, crossover design,~     13 OWO and 12 LN overnight fasted participants were studied on 3 separate occasions. On each~     day they consumed a 300 mL drink containing 75g glucose (Control) or 75g glucose plus 24g~     inulin (IN), or 28.2g resistant-starch (RS). A standard lunch was served 4 h after the test~     drink.~   "
76754|NCT02562352|"~     In an aging population, most seniors suffer from multiple chronic conditions. When the number~     of medications taken is ≥5 (polypharmacy), the burden of taking so many together can do more~     harm than good. This study will test a program focused on medication reduction involving~     patient, pharmacist and physician using current technology aimed at reducing the harms of~     polypharmacy. Reducing the risk of adverse effects from drugs or the interactions between~     them involves prioritizing the most important ones according to the patient's preference and~     stopping those which may no longer be necessary. Reducing the dose also reduces the risk of~     drug side effects. Patients, aged over 69 years taking ≥5 medications, will randomly receive~     the program immediately or at 6 months. The program involves information gathering from the~     patient, medication review with the pharmacist and then a consultation with the family doctor~     focused on discontinuing/reducing the dose of medications where possible using a 'pause and~     monitor' framework to assess the need for restart. An electronic program that detects drug~     adverse effects and flags potentially inappropriate medications will be integrated into a~     clinical pathway incorporating monitoring and follow up systems. This study will examine~     effects on patient and health relevant outcome measures as well as patients' and clinicians'~     experiences of the program. The results will be used to determine whether this system can be~     implemented as part of routine preventative care in older adults.~   "
76755|NCT02562339|"~     This is a prospective study that will examine psychosocial improvements among CF adolescents~     and caregivers going through the Stress Management and Resiliency Training - Relaxation~     Response Resiliency Program (SMART-3RP).~   "
76756|NCT02562326|"~     This is a double-blind, randomised, controlled, two-period crossover phase Ib trial using an~     individualised standard meal with a fixed nutrient ratio in subjects with type 2 diabetes~     mellitus to investigate post-prandial blood glucose control with BioChaperone insulin lispro~     compared to insulin lispro (Humalog®, Eli Lilly and Company) before and after a period of~     multiple daily dose administrations for 14 days. Each subject will be randomised to a~     sequence of two treatments, either BioChaperone insulin lispro-Humalog® or~     Humalog®-BioChaperone insulin lispro. Injections will take place immediately before an~     individualised standard meal in the morning of day 1, 2, 13, and 14. Insulin doses will be~     determined at the screening visit. During the outpatient phase the subjects will keep their~     basal insulin constant (except changes for safety reason). They will self-measure blood~     glucose at least 4 times daily (pre-prandial and at bedtime). In addition, on two days per~     outpatient period (Day 5 and 9) blood glucose will be measured 7 times daily (pre-prandial, 2~     hours post-prandial and at bedtime).~   "
76757|NCT02562313|"~     This study is constituted of 2 parts:~      Part A: A total of 36 patients will be enrolled in part A. Each eligible subject will~     participate in two 14-day treatment periods with Continuous Subcutaneous Insulin Infusion~     (CSII) of BioChaperone insulin lispro and insulin lispro (Humalog®, Eli Lilly and Company).~     Each treatment period consists of 10 treatment days under free living conditions (e.g. home /~     workplace) and under standardised conditions at the clinic. Various assessments for~     pharmacodynamics, pharmacokinetics, pump compatibility, short-term efficacy and safety are~     performed on selected days, including:~        -  Mixed Meal Test (MMT), Day 1, Day 3, Day 12 and Day 14, that will assess the~          post-prandial glucose response for 6 hours after individualized standard meal (fixed~          nutrient ratio) ingestion and bolus administration via CSII.~        -  Continuous Glucose Monitoring (CGM), (Day 1 - 14) that will be used in blinded mode~          (i.e. neither subjects nor the investigators are aware of the sensor glucose values).~        -  Pump compatibility (Day 1 - 14): Subjects will continue CSII treatment with the~          Investigational Medicinal Products (IMP) during the outpatient periods.~      Part B: A total of 44 patients will be enrolled. Subjects will be randomized to a 4-period~     cross-over study aiming at comparing the performance of BC Lispro and Humalog after a~     prandial bolus administration with two different CSII systems (Roche Accu-Chek® Spirit and~     Medtronic Paradigm® Veo™) or with a syringe. Pharmacodynamics, pharmacokinetics, pump~     compatibility and safety will be analyzed.~      Each period will include a mixed meal tolerance test with a CSII device and a mixed meal~     tolerance test with the same dose of insulin administered with a syringe.~   "
76758|NCT02562300|"~     Postpartum haemorrhage continues to be a leading cause of maternal morbidity and mortality~     worldwide and that is according to the estimates of the World Health Organization in 1998.~     Average blood loss during delivery progressively increases with the type of delivery, vaginal~     delivery (500 ml), cesarean section (1000 ml) and emergency hysterectomy (3500 ml) of blood.~      A reduction of operative blood loss at cesarean section has a great benefit to the patients~     in terms of decreased postoperative morbidity and a decrease in risks associated with blood~     transfusions. The routine use of oxytocin is associated with a significant reduction in the~     occurrence of postpartum hemorrhage.~      Excessive blood loss as estimated by a 10% drop in the hematocrit value postdelivery or by~     need for blood transfusion, occurs in approximately 4% of vaginal deliveries and 6% of~     cesarean births.~      Although many delivery units use oxytocin as the first line agent to prevent uterine atony at~     cesarean section, it may not be the ideal agent for prevention of postpartum haemorrhage~     especially in compromised patients with preeclampsia, cardiac disease or prolonged labor.~     Oxytocin and specifically its preservative chlorobutanol increases the heart rate and has~     negative inotropic, antiplatelet and antidiuretic effects.~      Misoprostol, a prostaglandin E1 analogue, has been shown in many studies to be an effective~     myometrial stimulant of the pregnant uterus which binds to prostanoid receptors.~      Misoprostol administration, either by oral or rectal route, has been shown to be effective in~     prevention of postpartum haemorrhage and is considered as an effective alternative to other~     conventional oxytocics especially in developing countries as it is cheap and thermostable.~      Pharmacokinetic studies suggested that the bioavailability of misoprostol after sublingual~     administration was higher than those after oral or vaginal administration.~      A few studies are now available for the use of sublingual misoprostol in the prevention of~     postpartum haemorrhage following vaginal delivery and have reported it as an effective and~     convenient route of administration.~      However, none of the studies conducted so far have evaluated the response of sublingual~     misoprostol for prevention of postpartum haemorrhage during cesarean section.~   "
76789|NCT02561897|"~     This is a prospective randomized comparative evaluation of Edoxaban and Warfarin for safety~     and efficacy in perioperative use in patients with non-valvular atrial fibrillation (AF)~     undergoing clinically indicated implantation or replacement of cardiovascular implantable~     electrical devices.The primary objective is to compare the rates of local and systemic~     bleeding in subjects randomized to Edoxaban compared to subjects randomized to continuous~     warfarin in within 30 days of cardiac rhythm device implant with concomitant non-valvular AF.~   "
76790|NCT02561884|"~     To demonstrate the bioequivalence of a Olostar Tab versus two co-administered reference IMPs~     Olmetec and Crestor.~   "
76791|NCT02561871|"~     The purpose of this study is to assess the safety and tolerability of intramuscular~     prime-boost regimens of Ad26.RSV.FA2 given either once or twice followed by Ad35.RSV.FA2~     (human adenovirus-vectored vaccine candidate) in healthy participants.~   "
76759|NCT02562287|"~     The clinical use of clozapine has been an unequivocal advance in the treatment of~     schizophrenia, a chronic and severe mental illness. A wealth of clinical data demonstrates it~     offers enhanced efficacy on both positive and negative symptomatology, improving cognition,~     functioning and quality of life. It is also associated with improved compliance and a~     continued efficacy in long-term treatment that can be translated into a reduction of~     suicidality and all-cause mortality. Because of preclinical evidence that it modulates~     neuroplasticity and prefrontal cortex connectivity, clozapine may be an interesting strategy~     for further severe psychotic illnesses. Nevertheless, even considering the growing use of~     other atypical antipsychotics in the management of bipolar disorder, a role for clozapine has~     been poorly defined. The clinical evidence-base for its use in this condition is largely~     based on uncontrolled naturalistic trials and retrospective studies and chart reviews.~     Several of these have supported clozapine's efficacy in treatment-resistant bipolar disorder.~     Possibly because of clozapine's profile of adverse effects and lack of interest from~     pharmaceutical companies, only two randomized trials have examined its effectiveness. Both~     suggest clinically relevant antimanic and mood-stabilizing properties. Therefore, the primary~     objective of this trial is to determine the effectiveness of clozapine for~     treatment-resistant bipolar disorder. Secondary objectives include examining the effects of~     treatment with clozapine on cognition and functioning of patients with bipolar disorder.~     Tolerability and safety of long-term clozapine use will also be examined. To that end, the~     investigators will conduct a clinical trial with 54 patients with a history of treatment~     resistance. Patients will be randomized to either open-label treatment with clozapine, in~     combination with lithium or valproate, or open-label treatment with an atypical antipsychotic~     with consistent evidence of efficacy in the treatment of bipolar disorder (olanzapine,~     quetiapine or risperidone), also in combination with lithium or valproate. Patients will be~     followed for one-year and time to all-cause treatment failure will be the primary outcome~     measure. It is the belief of the investigators that this study will generate meaningful~     clinical data of tremendous importance to validate clozapine as a legitimate treatment option~     for treatment-resistant bipolar disorder.~   "
76760|NCT02562274|"~     This study the investigators aimed to determine the effect of the herbal porridge containing~     the combined extract of mulberry and Vietnamese coriander (MP) on cognitive function and bone~     formation markers of menopausal women. Forty-five participants were randomly assigned to~     receive a placebo or MP (50, 1500 mg) treatments once daily for 8 weeks.~   "
76761|NCT02562261|"~     Activation of blood platelets is a typical finding in patients with systemic inflammation and~     sepsis.They seem to mediate key pro-inflammatory mediator secretion, immune-cell activation~     while their adhesion to the endothelium enhances the pro-coagulatory activity of endothelial~     cells impairing microcirculation thus, may lead to multiple organ dysfunction. However, the~     exact effects of bacterial products on platelet function have not been found to be consistent~     and may vary according to the species, the timing of the study, and the pathogenesis of~     sepsis. Data vary, including both increased and decreased platelet reactivity and aggregation~     among patients with sepsis compared to healthy controls. Defining platelet's behaviour during~     sepsis is particularly important in view of recent findings revealing potential association~     between antiplatelet therapy and reduction in short term mortality, incidence of acute lung~     injury and intensive care unit admission in critically ill patients.This study aims to~     measure P2Y12 mediated platelet reactivity, -using the point-of-care P2Y12 VerifyNow assay,~     in platelet reactivity units (PRU)- along different stages of sepsis, including~     bacteremia/uncomplicated infection, sepsis, severe sepsis and septic shock. Subgroup follow~     up of patients going along different stages will also be performed. At the end of this study~     analysis of clinical and laboratory findings in correlation with platelet reactivity will be~     performed to assess platelet aggregation during sepsis.~   "
76762|NCT02562248|"~     Inattentive behaviors are a common childhood condition that presents to the general~     pediatrician. While some of these behaviors are expected during childhood, others need~     work-up to ensure optimal functioning at home and school. A number of these children~     ultimately go on to have a mental health conditions, such as ADHD. However, inattentive~     symptoms represent a broad spectrum of potential behavioral and mental health conditions,~     such as pediatric anxiety which can masquerade as or co-exist with ADHD. Treatment is quite~     different and general pediatricians must have ways to facilitate the accurate identification~     of children needing further work-up and referral. Health information technology can greatly~     improve pediatricians' ability to identify and refer children with inattentive symptoms for~     further work-up. This study represents initial work to revise an existing computer decision~     support system's module for identification of ADHD to include screening questions and prompts~     for anxiety.~   "
76763|NCT02562235|"~     This study is designed to evaluate the safety, tolerability, pharmacodynamics and~     pharmacokinetics of riociguat at age-, sex- and body-weight-adjusted doses of 0.5 mg, 1.0 mg,~     1.5 mg, 2.0 mg and 2.5 mg TID in children from ≥6 to less than 18 years with pulmonary~     arterial hypertension (PAH) group 1. The study consists of two phases: titration phase up to~     8 weeks and a maintenance phase up to 16 weeks.~   "
76764|NCT02562222|"~     The aim of this study is to establish an optimized protocol of tDCS that normalize the lack~     of habituation and efficiency of inhibitory cortical circuits in migraine patients and~     determine tDCS polarity and the best cortical areas to stimulate which could normalize the~     lack of habituation and efficiency of inhibitory cortical circuits. For this, migraineurs~     volunteers will undergo to some tDCS protocols or sham tDCS.~   "
76765|NCT02562209|"~     This study evaluates the effects High Protein Atkin's Complete (lacto) VEgetaRian Diet~     (Acronym; 'PACER' diet) on weight, body composition and metabolic profiles in obese Asian~     Indians subjects living in north India.~   "
76766|NCT02562196|"~     The aim of this study is to evaluate an optimized protocol of tDCS that normalize the lack of~     habituation and efficiency of inhibitory cortical circuits in migraine patients. For this~     purpose, migraineurs volunteers will undergo to optimized tDCS protocol or sham tDCS.~   "
76767|NCT02562183|"~     In order to reevaluate safety and efficacy of human urinary kallikrein in treating acute~     cerebral infarction ,a multi-center, open label , single group study was designed. Expect to~     enroll 60 sites and 2186 subjects. Subjects will receive kallikrein treatment according to~     real clinical practice (suggest above 14days treatment) and 90 days follow up~   "
76768|NCT02562170|"~     Randomized controlled trial to look at early complications, cosmetic outcome, patient~     satisfaction and thickness of the tissue overlying the implant at the lower pole in immediate~     implant based breast reconstruction after Skin or Nipple Sparing Mastectomy with either a~     mesh (TiLOOP Bra) or an ADM (Protexa). Multicenter austrian trial with four breast cancer~     centers, 50 patients randomized 1:1 in the TiLoop or Protexa group.~   "
76815|NCT02561559|"~     In this study the investigators treat PM oligometastatic patients with SBRT. Our objective is~     to evaluate rate of local control of treated lesions in patients treated with Intensity~     Modulated Radiation Therapy (IMRT) using Volumetric Modulated Arc Therapy (VMAT) for lung~     metastases from STS.~   "
76816|NCT02561546|"~     An open-labeled phase II study to investigate preliminary efficacy using p53 gene therapy in~     treatment of diabetes concurrent with hepatocellular carcinoma (HCC).~   "
76769|NCT02562157|"~     Achieving gastro-jejunal or duodenal anastomosis (GJA ) by exclusive endoscopically is a real~     goal for many years in the development and research of the transluminal endoscopic surgery~     (N.O.T.E.S). Endoscopic treatment, including palliative antro duodenal stenosis by metallic~     stent, although minimally invasive, causes problems in long-term secondary obstruction and~     migration. Surgical treatment of these strictures is associated with significant morbidity~     and mortality . The complication rate and severity of post-operative surgery after gastric~     bypass Roux-en-Y anastomosis or gastroduodenal fistulas remain close to 5% with a mortality~     of 1%. After 3 years of experimental research on porcine model, our team has developed a~     procedure of gastro duodenal anastomosis using transgastric endoscopic minimally invasive~     surgical technique (or NOTES) - LBA UMRT24 CERC laboratory , Aix-Marseille University ,~     Faculty of Medicine North, with the aim to offer a credible alternative to conventional~     surgery.~      Thus the investigators propose to conduct a pilot prospective intervenionnal study. The~     investigators hypothetized that this technique would reduce morbidity and mortality clinical~     but also economic consequences of surgery while making it possible to obtain excellent~     results permeability and long-term functionality. This method uses a new concept of tissue~     apposition with a fully covered metallic stent to create the anastomosis under endoscopy~     exclusively. Ten patients with antro duodenal obstructions requiring surgical or endoscopic~     bypass will be included as part of an interventional biomedical research that will be~     conducted in one expert center. The duration of the inclusions will be 18 months. Then, the~     stent will be removed three months after insertion, at the end of the healing process, and~     each patient will be followed for one year. The primary endpoint will be the assessment of~     the feasibility of the procedure for gastro duodenal anastomosis using tissue apposition~     stenting and NOTES in human being. The secondary endpoints will be the clinical efficacy, the~     long term (1 year) patency of the anastomosis, the procedure duration, adverse events,~     morbidity and mortality, the quality of life and the length of stay.~      In case of failure of the NOTES procedure, the patient will be treated either by surgery or~     by conventional endoscopy according to the usual techniques without loss of chance. The risk~     / benefit ratio appears positive and a safety report will be issued after the first 4~     inclusions. There will be no supplementary examination in patient follow-up in this study for~     which a CT iconography and biology are enough. The material used in the context of this work~     is consistent with the legislation on medical devices and has received CE Mark (tissue~     apposition fully covered stent Axios ®).~   "
76770|NCT02562144|"~     The enrolled subjects will get an intravenous cannulation in both elbows. The subject will~     get before xylocaine spray is placed, the intervention-arm, one intravenous cannulation in~     one of the elbows, the other intravenous cannulation is placed in the other arm before~     placebo spray is placed, the control arm. The pain score during insertion of the cannulation,~     the incidence of adverse events and the success rate and degree of difficulty to place an~     intravenous cannulation. The subjects and the one who place the cannulations will be blinded~     to the treatment.~   "
76771|NCT02562131|"~     Simultaneous PET/MRI has the potential to improve the detection accuracy in recurrent~     prostate cancer, since it combines the excellent soft-tissue contrast of MRI with the high~     molecular sensitivity of PET in a single imaging session. The aim of this study is to~     evaluate the sensitivity and specificity of simultaneous 18F-Fluciclovine PET/MRI for~     detection of recurrent prostate cancer.~   "
76772|NCT02562118|"~     Background: Endocrine therapy is the standard treatment for hormone receptor positive breast~     cancer. However, both primary and acquired resistance occurs, and better strategies to~     improve treatment outcome and overcome resistance are urgently needed. There is known cross~     talk between RET and ER, and preclinical studies have suggested that combining a RET~     inhibitor with endocrine therapy may improve cell kill in breast cancer cell lines.~      Aim: To determine the safe dose of lenvatinib that can be co-administered with letrozole in a~     phase Ib study, followed by a phase II study to determine the efficacy of lenvatinib +~     letrozole in post-menopausal patients newly diagnosed with hormone receptor positive breast~     cancer in the neoadjuvant setting.~      Methods: Eligible patients will be treated with 2 weeks of single agent lenvatinib, followed~     by 12 weeks of lenvatinib + letrozole. Blood and tumor samples will be obtained from the~     patient serially to study tumor and host factors that may influence drug efficacy and~     toxicity.~      Importance of the proposed research: The combination of lenvatinib + letrozole may improve~     the treatment response in some ER+ breast cancers. The study will seek to identify biomarkers~     (eg tumor RET expression) that may select patients most likely to benefit from the~     combination therapy.~      Potential benefits and risks: The combination may improve treatment response. Adding~     lenvatinib may increase treatment risks, but these will be monitored closely. Pharmacokinetic~     analyses will also be performed to determine the drug levels achieved in the patients, and~     correlate that with treatment toxicity and efficacy.~   "
76773|NCT02562105|"~     This observational cohort aimed to re-evaluate the outcome of hematologic cancer patients~     admitted to the intensive care unit of Mansoura oncology center through a cohort study as~     regards their need for mechanical ventilation during two years.~   "
76774|NCT02562092|"~     This study aims to understand the barriers to receiving HIV testing and retention of care for~     at risk and HIV positive young adults. This study also seeks to determine the feasibility and~     acceptability of HIV testing in a non-clinical setting.~   "
76775|NCT02562079|"~     It is a study of basic research with mechanistically objectives and including clinical~     biological samples.~   "
76776|NCT02562066|"~     This randomized, double-blind, controlled, outpatient two-period, two-treatment crossover~     study is designed to evaluate the efficacy and safety of amifampridine phosphate in patients~     (ages 2 and above) diagnosed with certain genetic subtypes of CMS and demonstrated open label~     (amifampridine phosphate) or history of sustained amifampridine benefit from treatment.~   "
76777|NCT02562053|"~     Three hundred women with severe premenstrual syndrome will be divided into 3 groups using~     computer generated random numbers. Group 1 will receiveCombined oral contraceptives (COC)~     containing drospirenone (drospirenone 3mg+Ethinylestradiol 0.03mg) daily for 21 days starting~     from the 3rd day of menstruation in addition to oral fluoxetine 20 mg daily. Group 2 will~     receive fluoxetine 20 mg daily in addition to an oral placebo similar to COC daily for 21~     days starting from the 3rd day of menstruation.Group 3 will receive oral placebo similar to~     COC daily for 21 days starting from the 3rd day of menstruation in addition to a daily oral~     placebo similar in size, color and structure to fluoxetine.~   "
76778|NCT02562040|"~     The purpose of this study is to evaluate the effects of early adenotonsillectomy (eAT) on the~     behavior, sleep-disordered breathing symptoms and quality of life for children who snore, but~     do not have obstructive sleep apnea, as well as identify factors that moderate responses to~     the surgery. Half of participants will receive eAT, while the other half will be observed~     with watchful waiting and supportive care.~   "
76779|NCT02562027|"~     A principle objective of the study is to create a validated risk model for treatment~     selection. This will greatly enhance the ability to counsel patients regarding their specific~     risks/benefit ratio for surgery or SBRT. This will improve informed decision making on the~     part of the patient, and remove much of the subjectivity of treatment selection.~   "
76781|NCT02562001|"~     The spinal cord injury is identified as the major cause of permanent disability worldwide,~     with the loss of ability to walk being the largest and most devastating of them for these~     patients. Our goal is to analyze the effects of electrical transcranial direct-current~     stimulation (tDCS) combined with gait training with partial body weight support aided by~     robotic device (Lokomat, Hocoma) in the gait of patients with incomplete spinal cord injury~     (SCI). In this stratified randomized double-blind study, the participants will be randomly~     allocated into one of both groups, outpatients (GA) or inpatients (GI), and will receive~     active or placebo tDCS followed by gait training with Lokomat (GA: 3 sessions/week x 10 weeks~     = 30 sessions; GI: 5 sessions/week x 6 weeks = 30 sessions). The functional assessments~     (through clinical and functional scales, assess gait, muscle strength, spasticity, balance~     and pain) and neurophysiological (cortical excitability measured by transcranial magnetic~     stimulation, electroencephalography and functional near-infrared spectroscopy) will be held~     before and after the training period. The functional assessments will be also held after 15~     sessions (intermediate) and after 3 months follow up. The expected result is that patients~     that received the active tDCS presents an improvement over the ground gait after the Lokomat~     training period significantly greater than the placebo group, with relations between~     neurophysiologic, kinematics and functional measurements.~   "
76782|NCT02561988|"~     This is a Phase 1, open-label, dose-escalation study designed to evaluate the safety,~     tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antineoplastic activity of~     avapritinib (also known as BLU-285), administered orally (PO), in adult patients with~     advanced systemic mastocytosis and other relapsed or refractory myeloid malignancies. The~     study consists of 2 parts, a dose-escalation part (Part 1) and an expansion part (Part 2).~   "
76783|NCT02561975|"~     An injury of haematosis in post ischemic chronic heart failure limits the clinic tolerance.~      There is a correlation between injury of pulmonary diffusing, chronic heart failure intensity~     and aerobic physic ability evaluated by an heart-rate maximal exercise tolerance test (VO2~     max). This injury is a new follow-up parameter of cardiac function for the adult.~      The nature of damage (vascular or membrane) can be determined by the measure of double~     pulmonary diffusing capacity to carbon monoxide (CO) associated to nitric oxide (NO).~      Today, in chronic heart failure consecutive to a congenital heart disease, there is no data~     on evolution of membrane and capillar factors.It is impossible to predict if membrane damage~     will be the best factor correlated to the VO2max in patients suffering from complex~     congenital heart disease.~      Assessing these parameters could be an comparative evaluation of heart-rate exercise~     tolerance test with VO2max and an early control of his damage without risks related to~     heart-rate maximal exercise and independently of age, sex, hemoglobin, type of heart~     disease.These results would have an early prognostic value that would permit to refine the~     follow-up and the treatment.~      The main objective of this trial is to assess the statistic correlation between the membrane~     injury of alveolar-capillary diffusing at rest and aerobic physic ability restriction in~     children and adults suffering from complex congenital heart disease.~   "
76784|NCT02561962|"~     This is a first in human phase 1 multicenter open label study in subjects with relapsed or~     refractory multiple myeloma.~   "
76785|NCT02561949|"~     The research will first examine data obtained from YRI participants to investigate effects of~     the group sessions on psychosocial functioning outcomes in youth aged 15 - 24. The research~     also intends to examine whether youth participating in YRI and complementary income~     generating activities will fare better than an employment only control group. Finally, the~     research intends to examine whether utilizing lay health workers are a is cost-effective and~     scalable method for addressing mental health concerns.~      The research will investigate the following hypotheses:~        1. Participants who are exposed to YRI will demonstrate greater reduction in mental health~          and behavioral problems than participants who are waitlisted for YRI over the same~          period; emotion regulation will operate as a major mechanism of YRI improvements; high~          comorbidity will be a treatment modifier;~        2. Improvements in mental health and functioning due to YRI will lead to (mediate) greater~          employment outcomes and superior economic self-sufficiency over time; and~        3. Homelessness, orphanhood, young parenthood, and high problems in emotion regulation~          co-morbid with other mental health conditions will be major moderators lessening the~          effectiveness of YRI.~        4. Lay and trained practitioners at agencies participating in the combined mental~          health-employment program will demonstrate high fidelity to evidence-based treatment~          components and that good satisfaction, social support, and professional exchange of~          evidence-based practices will emerge.~   "
76786|NCT02561936|"~     The purpose of this study is to compare the rate and extent of absorption of rilpivirine in~     healthy adult participants following: 1) administration of a single dose of two different~     oral dispersible tablet formulation candidates and of an oral granules formulation with that~     following administration of a single dose of the 25-milligram (mg) oral tablet (EDURANT),~     after a standardized breakfast; 2) administration of a single dose of one selected oral~     formulation candidate (a dispersible tablet or granules) in different fed conditions~     (standardized breakfast or yoghurt) and in the fasted state and breakfast and 3)~     administration of a single dose of one selected oral formulation candidate (a dispersible~     tablet or granules) dispersed in water or in orange juice, in fed condition (standardized~     breakfast).~   "
76787|NCT02561923|"~     The purpose of this study is to assess the independent effects of both a 4-Factor prothrombin~     complex concentrate (PCC) - (Kcentra) and Tranexamic acid (TXA) on the bleeding parameters~     (bleeding duration and blood volume) following a punch biopsy, in addition to assessing their~     effects on the anticoagulant/pharmacodynamic (prothrombin time and endogenous thrombin~     potential) changes induced by rivaroxaban at steady state, to better understand their~     potential role in bleeding reversal.~   "
76788|NCT02561910|"~     The effectiveness of laparoscopic inguinal hernia repair still remains unclear. During a one~     year period a total of 1208 inguinal hernias in 952 patients were consecutively operated~     using the laparoscopic technique by a total of 11 general surgeons in daily clinical routine.~      Laparoscopic hernia repair in the TAPP technique seems to have the potential to become the~     standard procedure in inguinal hernia repair in future.~   "
76817|NCT02561533|"~     Immunohistochemical detection of the BRAF-V600E mutation on pre-operative fine needle~     aspiration biopsy (FNAB) from patients suspected for papillary thyroid carcinoma, using the~     mutation specific antibody VE1.~   "
76792|NCT02561858|"~     Patients who are overweight or obese, diabetic or not, share with those who are suffering~     from uric stones the same way to remove abnormal acidity of the body in urine, ie a kidney~     ammoniogenesis default. This results in an overly acidic urine pH which is directly~     pathogenic in people predisposed to develop uric stones because the precipitation of urate~     soluble uric acid is accelerated in acid medium.~      Excess visceral fat, particularly perirenal, this defect may promote formation of renal~     ammonium. Indeed, the perirenal fat is adjacent to the renal cortex and shares with it a~     common arterial supply via the plexus Turner. Adipokines and fatty acids of the perirenal fat~     are predisposed to gain the renal cortex, seat of the ammoniogenesis. In humans the~     pathogenic role of the perirenal fat is demonstrated in chronic kidney disease and essential~     hypertension. However, the amount of fat and perirenal that of intra-abdominal fat are~     positively correlated.~      Investigators hypothesis is that the perirenal fat also exert a pathogenic role in uric~     because of anatomical links between kidney stones and greasy environment and because excess~     fatty acids reaching the renal cortex decreases ammoniogenesis in an animal model metabolic~     syndrome.~      For the test, the investigators will compare the amount of fat and perirenal renal ability to~     form ammonium in patients with uric or calcium lithiasis taking into account the amount of~     intra-abdominal fat.~   "
76793|NCT02561845|"~     Most PCI patients are at very high cardiovascular (CV) risk, and as such here is an increased~     need for intensive lipid management in Percutaneous Coronary Intervention (PCI) patients and~     the population is well suited to demonstrating rosuvastatin's low density~     lipoprotein-cholesterol (LDL-C) lowering efficacy.Most PCI patients are at very high CV risk,~     and as such here is an increased need for intensive lipid management in PCI patients and the~     population is well suited to demonstrating rosuvastatin's LDL-C lowering efficacy.The purpose~     of this study is to observe the effectiveness of statins on lipid level reduction (LDL-C,~     high density lipoprotein-cholesterol (HDL-C), Triglyceride (TG), and non-HDL-C) and lipid~     goal attainment according to recent guidelines.~   "
76794|NCT02561832|"~     This is an open-label study to assess the safety, tolerability and efficacy of olaparib in~     combination with carboplatin. There are two parts in this study: Part A, a dose escalation in~     patients with advanced Human Epidermal Growth Factor 2 (HER-2) negative breast cancer and~     Part B, a dose expansion in the neoadjuvant treatment of HER-2 negative breast cancer~     patients with germline Breast Cancer Susceptibility Gene (BRCA)1/2 mutations.~   "
76795|NCT02561819|"~     This study will determine if air-displacement plethysmography (ADP) provides accurate~     measurement of body composition (percent body fat and fat-free mass) in pediatric patients~     with intestinal failure, as compared to body composition measured by alternative standard~     methods, including deuterium dilution, bioimpedance analysis (BIA), dual x-ray absorptiometry~     (DXA) when clinically indicated, and routine anthropometric measurements.~   "
76796|NCT02561806|"~     The main purpose of this study is to evaluate the efficacy of the study drug ixekizumab~     compared to ustekinumab in participants with moderate-to-severe-plaque psoriasis.~   "
76797|NCT02561793|"~     440 women with expected poor ovarian response undergoing IVF/ICSI (intracytoplasmic sperm~     injection) will be randomly divided into 2 groups using computer generated random numbers .~     Group 1 ( study group) will receive Dehydroepiandrosterone (DHEA) 25 mg ( DHEA 25mg, Natrol ,~     USA) t.d.s daily for 12 weeks before starting IVF/ICSI cycle. Group 2 ( control group) will~     receive a placebo. Patients included in the study will be subjected to full history taking~     and clinical examination. On the second day of menstruation serum FSH, LH, Prolactin and~     Oestradiol will be assessed and the antral follicular count (AFC) will be assessed using a~     vaginal ultrasound scan. AFC will be defined as the number of follicles measuring 3-10mm.~      All patients will have gonadotropin antagonist protocol with Human menopausal gonadotrophin~     (HMG) stimulation until the day of (Human chorionic gonadotrophin (HCG) administration. On~     the day of HCG administration, ovarian ultrasound scan will be performed using a transvaginal~     probe. Oocytes will be aspirated 34-36 hours after HCG administration. Oocytes will be~     fertilized and embryos will be transferred. Both groups will be compared regarding the~     proportion of pregnancy.~   "
76798|NCT02561780|"~     This study examines the effectiveness of a school based mental health literacy intervention~     for high school students, on improving mental health knowledge and reducing stigma.~     Twenty-four high schools in the regional area of Ottawa, Canada were randomly assigned to~     either the curriculum or control condition at a two to one ratio. The educational curriculum~     was integrated within grade 11 and 12 Provincial Healthy Living courses, delivered by~     teachers, and replaced existing educational content on mental health.~   "
76799|NCT02561767|"~     This study is designed to determine the efficacy and safety of allogeneic bone marrow-derived~     mesenchymal stem cells in kidney transplantation from Chinese donation after citizen's death~     (DCD). A pair uremia patients receiving kidney grafts from a same donor are randomized into~     two groups: MSCs group and control group. Besides routine induction therapy (ATG or~     Basiliximab) and maintenance immunosuppressive drugs (low-dose Tacrolimus + MPA +~     prednisone), patients in MSCs group are administered MSCs treatment (1*10^6/kg). Allogeneic~     bone marrow-derived MSCs (1*10^6/kg) are given intravenously at day 0 (post renal reperfusion~     during surgery), day 7, day 14 and day 21. The renal allograft function, rejection,~     patient/graft survival and severe adverse events within 12 months post-transplant are~     monitored.~   "
76800|NCT02561754|"~     The goal of this study is to explore the impact of two different diets (conventional vs.~     enhanced stop light) and two different delivery systems (face-to-face vs. remote) on weight~     across 18 months in overweight and obese adolescents with intellectual and developmental~     disabilities.~   "
76801|NCT02561741|"~     A single center, single dose, open-label, randomized, 3-period, 6-sequence, crossover study~     conducted in normal healthy subjects to evaluate the effect of a high- and low-fat meal on~     the pharmacokinetics (PK), bioavailability (BA), and safety of COV155.~   "
76802|NCT02561728|"~     The purpose of this study is to examine a group of patients requiring helmet therapy (either~     patients with plagiocephaly or post-surgical patients) to compare outcomes of infants treated~     with the Hanger helmet (Hanger, Inc.) to outcomes of infants treated with the P Pod Helmet~     (Lorica Scientific, LLC). Currently both helmets are prescribed at CCHMC. The investigators'~     goal is to determine which helmet is more effective in skull remodeling and to standardize~     the investigators' care for these patient types.~   "
76803|NCT02561715|"~     Anosognosia is a recognised condition for people with Parkinson's, and is the result of~     physiological damage on brain structure.~      Surgical Parkinson Disease Nurse Specialists have noticed that when reviewing the pre-surgery~     videos 12 months post-DBS, patients have forgotten and are shocked at how bad their symptoms~     were prior to surgery (personal communication), which may not be reflected in the change in~     QoL reported.~      This lack of awareness, while possibly helpful in everyday life, may lead to effective~     treatments looking ineffective, or the benefits in QoL of effective treatment appearing~     reduced. This confound may not only reduce the apparent effectiveness but also the related~     cost-effectiveness of treatment. As cost-effectiveness is determined by both size and~     longevity of an effect, current methods of capturing these data may be suboptimal.~   "
76804|NCT02561702|"~     Charcot Marie Tooth Disease is a family of inherited peripheral neuropathies, with over 70~     causative genes identified to date.1-4 Muscle cramps are frequent in CMT, affecting up to 85%~     of patients with some subtypes of CMT. These cramps impact quality of life and have been~     identified as an important therapeutic target for clinical trials in CMT.1-4 There is no FDA~     approved treatment for muscle cramps.5 Mexiletine is a sodium channel blocker approved for~     treatment of arrhythmias. As a sodium channel blocker, mexiletine offers the promise of~     effective therapy for muscle cramps.~   "
76805|NCT02561689|"~     Background: Occlusal caries is the main reason for restorative therapy in the young permanent~     dentition, but restorations have limited survival time and may also weaken the tooth. An~     intact fissure sealing is an effective preventive treatment of occlusal caries lesions and~     may be used therapeutically to arrest the caries progression. However, the major challenge~     with fissure sealants is the frequent need for re-treatments, mostly due to inadequate~     retention.~      Purpose: To quantify the longevity and effectiveness of the 6 resin sealants used~     prophylactically and therapeutically in permanent molar teeth.~      Study design: The study is carried out as a prospective, clinically controlled study with~     split-mouth design, where each of the 60 dentists/dental hygienists from 13 municipalities in~     Denmark uses 2 of the 6 sealants. The treatments are examined clinically and radiologically~     after 1, 2, 3, and 5 years.~   "
76806|NCT02561676|"~     Chronic pain (pain that is that is present for a long period of time) is very common among~     people with spinal cord injury (SCI).~      The purpose of this study is to compare how well two different web-based education programs~     reduce the level to which chronic pain interferes with daily activities and well-being.~   "
76807|NCT02561663|"~     Rationale: Subjects with the metabolic syndrome have an increased risk of developing~     cardiovascular disease and a twofold risk of developing hypertension. A functional food~     ingredient with the ability to improve arterial stiffness, microcirculation and/or the~     ability to reduce blood pressure could potentially contribute to the delay or prevention of a~     range of cardiovascular diseases and could provide additional complimentary alternatives to~     pharmacological and lifestyle based interventions in the maintenance of cardiovascular~     health.~      Objective: To assess the acute (2h) and short term (2 days and 4 week) effects of daily~     administration of 5g of NWT03 (an egg-protein hydrolysate) on carotid-radial Pulse Wave~     Velocity (cr-PWV). Secondary objectives are to assess its effects on carotid-femoral PWV,~     characteristics of microcirculation, systolic and diastolic blood pressure, lipid and~     lipoprotein metabolism, glucose metabolism and incretins.~      Study design: Investigators propose to carry out a randomized, double-blind, placebo~     controlled crossover study.~      Study population: Eligible subjects will be male or female, non-smokers between 18-75 years~     of age and will be otherwise healthy, but meeting at least three criteria of the Metabolic~     Syndrome (MetS). It is estimated that 80 otherwise healthy subjects with MetS will be~     randomised, to result in a minimum of 72 evaluable subjects (drop out maximal 10%) at the end~     of the study.~      Intervention: Subjects will be randomly allocated to receive 5g of NWT-03 and placebo, once~     daily, on separate occasions, for a period of 4 weeks and with a washout period between the~     two interventions of typically 4 weeks. However, this period may be shortened by 2 weeks or~     extended by 8 weeks, depending on the availability of the subject. Total study duration will~     be 10 - 16 weeks, depending on the duration of the washout period.~      Main study parameters/endpoints: Measurements will be performed at the start and end of each~     4-week intervention period. Effects of NWT-03 supplementation will be calculated as the~     absolute differences between values obtained at each period. The main study endpoint is the~     change in cr-PWV.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: Before the study starts, subjects will be screened to determine eligibility~     during a screening visit. During this visit, body weight, height, waist circumference and~     blood pressure will be measured and a venous blood sample (10 mL) will be collected. During~     the study, subjects will receive NWT-03 and placebo powders in random order and are asked to~     consume it on a daily basis. At visits 2, 3, 4, 5, 6 and 7 (days 0, 2, 27, 56, 58 and 83 of~     the study), cr-PWV, cf-PWV and office blood pressure will be recorded. A fundus photograph~     and a blood sample (20mL) will be taken in fasting condition. 2 hours after intake of the~     designated study product cr-PWV, cf-PWV and office blood pressure will again be measured and~     another fundus photograph will be taken. Additionally, a blood sample (20 mL) will be~     collected. Thus, in total 270 mL blood will be drawn. A pregnancy test will be taken in~     females of childbearing potential at visits 2 and 5. Subjects will be asked to fill out a~     food frequency questionnaire and to provide a spot urine sample at visits 4 and 7.~     Furthermore, subjects will be asked to keep a study diary throughout the duration of the~     study. Total time investment for the subjects will be approximately 19 hours. Apart from~     bruises or hematoma, rarely induced by blood sampling, no risks are associated with~     participation in this study.~   "
76808|NCT02561650|"~     A single center, single dose, open-label, randomized, 3-period, 6-sequence, crossover study~     conducted in normal healthy subjects to evaluate the effect of a high- and low-fat meal on~     the pharmacokinetics (PK), bioavailability (BA), and safety of COV155.~   "
76809|NCT02561637|"~     Patients in fast-track programmes are required to take an active part in their treatment and~     rehabilitation. Spouses of older patients can often provide valued practical and emotional~     support, reducing stress, pain and length of stay - yet they are seldom invited to~     participate in a supporting role. The aim of this study is to investigate the effect of~     spouses' involvement in older patients fast-track treatment programs using case management as~     intervention. A two-group quasi-experimental design with pre-test and repeated post-test~     measures (protocol approved in November 2012) was used. Patients aged 65 years or older going~     through a fast-track programme for a total hip replacement and their spouses was recruited in~     dyads from one Danish orthopaedic ward for the intervention group (n=15) and for the control~     group (n=14). Data was collected from both groups at baseline, two weeks and three months~     after surgery. Outcome measures for patients include: functional status, nutrition, pain,~     depression and healthcare consumptions; and for spouses: caregiver satisfaction and~     difficulties and anxiety.~   "
76810|NCT02561624|"~     The use of long-lasting insecticide treated nets (LLINs) is shown to reduce malaria~     prevalence. The Tanzania Net Voucher Scheme has been an active component of bed net~     distribution to pregnant women in Tanzania since 2004. The transition from paper vouchers to~     electronic vouchers in this program has increased efficiency and the ability to track and~     distribute nets since 2007. Although the program has been successful, to date, electronic~     voucher redemption varies widely across the country and it has not been clearly established~     as to what barriers exist for women who receive electronic vouchers in the program. This~     cluster-randomized trial was designed to examine perceived barriers to electronic voucher~     redemption among pregnant women and to evaluate if educational and personalized text messages~     around electronic voucher redemption and bed net usage will increase electronic voucher~     redemption when directed at pregnant women who receive electronic vouchers in the currently~     existing program.~   "
76811|NCT02561611|"~     The purpose of the WorkACTIVE-P study is to assess the outcome of an innovative~     multi-component intervention focused on increasing energy expenditure and re-balancing the~     disrupted energy balance equation of sedentary workplaces with an ultimate target of reducing~     workers' abdominal obesity.~   "
76812|NCT02561598|"~     The purpose of the study is to develop methods to identify predictors of Malignant~     Hyperthermia.~   "
76813|NCT02561585|"~     This clinical trial attempts to investigate the efficacy and safety of LEO 124249 ointment in~     the treatment of alopecia areata and the molecular disease mechanism and biomarkers.~   "
76814|NCT02561572|"~     Preoperative anxiety has been associated with adverse consequences, including increased~     anaesthetic and analgesic requirements and overall dissatisfaction with care. Traditionally~     this has been treated with sedative drugs, such as benzodiazepines, but these can be~     associated with a sedative hangover with sedation continuing into the postoperative period.~     This is undesirable in patients undergoing neurosurgical procedures, as there is a need to~     assess neurological status in the immediate postoperative period. Acupuncture at the Yintang~     point (on the forehead between the eyebrows) has been shown to effectively reduce~     preoperative anxiety, but studies undertaken in the United Kingdom and neurosurgical~     population are lacking. The investigators aim to investigate the effect of acupuncture at the~     Yintang point on preoperative anxiety. Anxiety levels will be measured using two validated~     questionnaires: the State-Trait Anxiety Inventory (STAI) and Amsterdam Preoperative Anxiety~     and Information Scale (APAIS).~   "
76917|NCT02560207|"~     This study evaluates target attainment after either intermittent intravenous bolus or~     intravenous continuous infusion of cefotaxime in critically ill patients. Critically ill~     patients will be randomized to intermittent infusion or continuous infusion of cefotaxime.~   "
76820|NCT02561494|"~     Nefopam will be administered to the patients undergoing laparoscopic gastrectomy under the~     total intravenous anesthesia (TIVA).~      The investigators will evaluate whether the nefopam can decrease the total amount of~     remifentanil administered during the operation, which will reduce the acute opioid tolerance~     and following consumption of fentanyl during postoperative period.~   "
76821|NCT02561481|"~     ASD is a diverse disorder starting in early childhood and characterized by social~     communication impairment as well as restricted interests and repetitive behaviors. It affects~     1:68 children and is an enormous medical and economic problem for which there is no~     established, mechanism-based treatment. Sulforaphane is an isothiocyanate derived from~     broccoli, and has potent activity in transcriptionally up-regulating genes that control~     mechanisms whereby aerobic cells protect themselves against oxidative stress, mitochondrial~     dysfunction, and inflammation.~      This study is a clinical trial of oral sulforaphane (as broccoli seed powder) in 50 boys and~     girls (3-12 years) with ASD in 3 phases over 36 weeks. In Phase 1, 25 children will receive~     active drug and 25 will receive placebo for 15 weeks; in Phase 2, all children will receive~     sulforaphane from 15-30 weeks; in Phase 3, children will receive no treatment for 6 weeks.~     Study visits will take place at screening, 7, 15, 22, 30 and 36 weeks, when the Ohio Autism~     Clinical Clinical Impressions Scale - Severity and Improvement (OACIS-S and OACIS-I),~     Aberrant Behavior Checklist (ABC) and Social Responsiveness Scale (SRS) will be recorded.~     Children will be monitored with physical examinations and for toxicity with clinical~     laboratory studies and examine possible biomarkers: Nuclear factor-erythroid factor 2 (Nrf2),~     oxidative stress and mitochondrial function, the mechanistic target of rapamycin (mTOR)~     pathway and cytokine expression. In addition, prior to the main clinical trial, a pilot study~     will be carried out in 10 children with ASD, 6-12 years of age, who will receive~     sulforaphane, 2.2 micromoles/kg daily for 14 days. Blood and urine samples before and at the~     end of treatment will be collected, in order to measure several parameters that are likely to~     demonstrate expected effects of sulforaphane, to standardize the assays and procedures, and~     to determine the most effective measures.~   "
76822|NCT02561468|"~     Nefopam is administered as a preemptive analgesic drug to the patient undergoing breast~     cancer surgery. It will be evaluated whether postoperative acute and chronic pain can be~     reduced.~   "
76823|NCT02561455|"~     The purpose of the study is to provide access to continued treatment for subjects who~     participated in other Astellas sponsored ASP2215 trials that completed the primary analysis~     and for whom the Investigator feels may have potential to continue to derive clinical benefit~     from the treatment with ASP2215, and who did not meet any of the study discontinuation~     criteria in the present study.~   "
76824|NCT02561442|"~     The proposed study aims to assess the time above MIC (4 mg/mL), and the~     pharmacokinetics/pharmacodynamics and bioavailability of 1 g ceftriaxone administered by~     constant rate subcutaneous infusion over 2 hours compared with 1 g of ceftriaxone~     administered as a constant IV infusion over 0.5 hours. In addition, the study will compare~     the results obtained after 1 g ceftriaxone intravenous or subcutaneous administration with 2~     g ceftriaxone administered subcutaneously~   "
76825|NCT02561429|"~     Skin prick test (SPT) was used for diagnostic test for type 1 hypersensitivity. The efficacy~     and safety of SPT were proved. The positive control of SPT is histamine.~      In Thailand, the most common concentration of histamine for SPT is 10 mg/ml. However, in some~     practice they use other concentration (1, 2.5 mg/ml).~      This study will find the proper concentration of histamine for positive control use in SPT.~   "
76826|NCT02561416|"~     Purpose:~      Fibromyalgia syndrome (FMS) is a disabling condition mainly characterized by chronic~     widespread pain, disturbed sleep, fatigue, and distress. The estimated overall prevalence of~     FMS in Europe is 2.9% and it incurs in high personal, social and healthcare costs. Available~     treatments in FMS are not curative and there is some evidence of positive effects of~     mindfulness-based stress reduction (MBSR) in patients with chronic pain and FMS.~     Nevertheless, although promising, the positive findings obtained in previous studies~     implementing mindfulness-based interventions in patients with FMS have to be interpreted with~     caution due to important methodological limitations (e.g. absence of randomization, high~     attrition rates, or small sample sizes). Therefore, further research in larger studies using~     more adequate methodologies is warranted. Furthermore, little is known about putative~     neurobiological processes underpinning the effects of mindfulness training in patients with~     chronic pain.~      Aims: The aim of this randomized, controlled trial (RCT) is two-fold: firstly, to assess the~     effectiveness and cost-utility of MBSR added to treatment as usual (TAU); and secondly, to~     evaluate the effects of the compared interventions on neurobiological parameters.~     Specifically, MBSR will be compared to an active control which was previously reported as a~     cost-effective intervention (TAU + FibroQol psycho-educational program; Luciano et al., 2013)~     and also vs. TAU alone (in a 12-month follow-up RCT). Brain structure and function of~     pain-relevant areas and levels of inflammation markers (cytokines) will be assessed pre-post~     interventions in half of the study participants.~      Methods:~      Design: RCT with three arms:~        1. TAU + MBSR,~        2. TAU + FibroQoL and~        3. TAU.~      Sample: 180 adults with FMS according to the ACR 1990 criteria (N=60 for each study arm) will~     be recruited from from the Parc Sanitari Sant Joan de Déu Rheumatology Service, Sant Boi de~     Llobregat, Spain. Half of the participants will be randomly selected to participate in the~     neurobiological pre-post evaluation (N= 30 each group). All patients will be assessed at~     baseline, post-intervention and 12-month follow-up for clinical variables, prep-post~     intervention for biomarkers study, and baseline and 12-month follow-up for cost-related~     variables.~   "
76827|NCT02561403|"~     The purpose of this study is to conduct a pilot trial investigating cognitive training in~     older Veterans with a history of traumatic brain injury (TBI) to assess training effects,~     acceptability of training to participants, and to explore whether other factors influence~     training effects.~   "
76828|NCT02561390|"~     The prevalence of Allergic rhinitis(AR) and asthma was increased world wide. In 1998, ISAAC~     found that prevalence of AR and asthma inThailand was in moderately high group.~      Tests for immediated reaction SPT and spIgE, were used for evaluated sensitization of~     allergen in patient. They guided the investigators for proper management as well as patient~     education. Clinician will use the result for choose allergen in case that might need~     immunotherapy.~      SPT is safe and more economic for patient. Specific IgE has an advantage in patient who~     cannot withhold antihistamine prior SPT. In United state had a trial of result between SPT~     and spIgE for cockroach, cat, house dust mite and mold. It showed the correlation between two~     tests. In Thailand, the investigators haven't had data about it yet.~   "
76829|NCT02561377|"~     This study evaluates the efficacy of a 12-month resistance training on metabolic control and~     reducing the risk of diabetes.~   "
76830|NCT02561364|"~     The purpose of this study is to evaluate the fetal biophysical profile (BPP) scoring in~     pregnant women from 20 weeks-0 days' to 36 weeks-6 days' gestation. A biophysical profile~     (BPP) is a score that is intended to assess fetal well-being. This test will be performed~     within the expected time of the routine ultrasound exam.~   "
76831|NCT02561351|"~     The purpose of this study is to determine mean or median of fractional exhaled nitric oxide~     (FeNO) in Thai atopic asthmatic children that divided into subgroups due to asthma~     exacerbation according to the global initiative for asthma guideline.~   "
76832|NCT02561338|"~     This study evaluates the safety, tolerability, efficacy and population PK of HMS5552 in type~     2 diabetic adult subjects,there will be 5 groups ,4 groups will receive HMS5552,while 1 will~     receive placebo.~   "
76833|NCT02561325|"~     Many large-scale epidemiological studies have established a link between the average~     consumption of table salt (sodium chloride) and blood pressure. In France a survey conducted~     in 2001 showed that the average consumption of salt is 9 to 10g per people / day, and health~     authorities considered it appropriate to reduce consumption about 20%, by limiting~     contributions of sodium in prepared foods, bread.~      In terms of basic and clinical research, the biological effects of sodium chloride dietary~     intake, have been the subject of numerous studies for several decades. This work showed that~     all subjects do not react uniformly to sodium chloride flows, determining what the~     investigators call people sodium-sensitive. For these people the sodium intake elevated~     blood pressure, much more marked than in subjects called sodium-resistant.~      Sodium-sensitive people represent 10 to 30% of the population. A marked over-representation~     of this phenotype was observed in patients with hypertension or a family history of~     hypertension.~      In addition, studies conducted in animals and humans indicate that sodium intake has a~     different impact on biological parameters mentioned above, as is done in the form of chloride~     salt or bicarbonate of sodium.~      Based on these factors, investigators developed a clinical trial protocol intended to~     highlight a possible differential effect in the biological effects of the same sodium intake~     (2.56 g / day) orally, depending on the nature salt.~   "
76834|NCT02561312|"~     Chronic blood transfusions are essential supportive care for sickle cell patients at high~     risk for morbidity and mortality due to stroke. These patients, however, are at risk for iron~     overload. In the investigator's comprehensive sickle cell center, the investigators support~     chronic transfusion with rapid manual partial exchange transfusions (RMPET) using a single~     access central line port. The investigators do not have a comprehensive adult sickle cell~     program but upon transition of patients the patients would be provided simple transfusion~     (ST) in an adult ambulatory infusion setting due to nursing acuity needed for RMPET. The~     investigators plan to study the institution's participants currently on chronic transfusion~     support and compare different transfusion modalities to better understand the effects from~     switching from RMPET to ST. To date, there are no such comparisons within and between sickle~     cell patients in the literature.~   "
76835|NCT02561299|"~     The purpose of this study is to prospectively evaluate acute and long term clinical results~     of orbital atherectomy (OA) with adjunctive drug coated balloon (DCB) angioplasty versus DCB~     angioplasty alone for treatment of Peripheral Artery Disease (PAD) in below the knee (BTK)~     lesions.~   "
76836|NCT02561286|"~     The incidence of HIV/AIDS among African American men who have sex with men (MSM) is alarming,~     and the public health response to this urgent situation has been hampered by a lack of sexual~     risk reduction interventions with solid evidence of efficacy in this population. Accordingly,~     the broad, long-term objective of the proposed research is to identify interventions to~     reduce the risk of sexually transmitted infection (STI) among African American MSM. This~     application seeks funds to develop and test the efficacy of a theory-based, contextually~     appropriate behavioral intervention to reduce sexual risk behavior among African American~     MSM. Intervention development will be guided by social cognitive theory, the theory of~     planned behavior, qualitative information from focus groups, and findings from a longitudinal~     survey of men from the study population. A one-on-one intervention will be utilized to~     address the specific prevention needs of each man and to allay participants' concerns about~     revealing their sexual involvement with men by virtue of participating in a group or workshop~     intervention. The study will utilize a randomized controlled trial design, with baseline,~     immediate post intervention, and 6 and 12 months post intervention assessments. The~     participants will be African American MSM who will be randomized to a one-on-one sexual risk~     reduction intervention or a one-on-one health promotion intervention that will serve as the~     control condition. The primary outcome is consistent condom use during anal and vaginal~     intercourse. The study will test whether the intervention increases the consistent use of~     condoms during anal intercourse, the primary outcome, whether it decreases other sexual risk~     behaviors, and whether social cognitive theory variables mediate the effects of the~     intervention on consistent condom use. This study will provide an urgently needed~     intervention to reduce the risk of HIV and other STIs in one of the highest risk populations~     in the United States.~   "
76837|NCT02561273|"~     This phase I/II trial studies the side effects and best dose of lenalidomide when given~     together with combination chemotherapy and to see how well they work in treating patients~     with newly diagnosed stage II-IV peripheral T-cell non-Hodgkin's lymphoma. Drugs used in~     chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and~     etoposide, work in different ways to stop the growth of cancer cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Lenalidomide may~     stop the growth of peripheral T-cell non-Hodgkin's lymphoma by blocking the growth of new~     blood vessels necessary for cancer growth. Giving combination chemotherapy with lenalidomide~     may be a better treatment for peripheral T-cell non-Hodgkin's lymphoma.~   "
76838|NCT02561260|"~     In recent years, more and more previously thought to be unknown encephalitis was found to be~     a specific antigen associated encephalitis，but because of the lack of recognition in the~     clinic, usually been misdiagnosed as other causes of encephalitis. Therefore, it is urgent to~     establish a database of autoimmune encephalitis in Chinese population. The prospective~     clinical trial of atutoimmune encephalitis in China, by screening the autoimmune encephalitis~     associated antibody and summarizing the cases analysis, in order to provide evidence for~     clinical diagnosis and treatment of autoimmune encephalitis.~   "
76839|NCT02561247|"~     The primary objective of this study is to evaluate the efficacy of the Gambro Prismaflex®~     HF20 Set based on testing the hypothesis that it delivers sufficient renal replacement~     therapy to effectively treat acute kidney injury (AKI) in pediatric patients by reducing~     blood urea nitrogen (BUN).~   "
76840|NCT02561234|"~     This is the first-in-human study of the safety of increasing dose levels of AEB1102 in~     patients with advanced cancers. The study will also evaluate the amounts of AEB1102 in blood,~     the effects of AEB1102 on blood amino acid levels and tumor growth.~   "
76841|NCT02561221|"~     The primary aim of this trial is to develop and test the effectiveness of a 24 month,~     patient-centered, pragmatic and scalable obesity treatment program delivered within primary~     care, inclusive of an underserved population. Half of the participants will receive a~     behavioral intervention delivered in a primary care setting and half of the participants will~     receive usual care.~   "
76854|NCT02561039|"~     This study will assess the efficacy and safety of ibandronate (Bondronat), administered~     intravenously (IV) or orally (PO), in participants with malignant bone disease and moderate~     to severe pain. Participants will be randomized to receive ibandronate either as a 6-mg IV~     infusion every 3 to 4 weeks or a 50-mg tablet PO daily. Pain response and Karnofsky~     Performance Index (KPI) will be measured at intervals throughout the study. The anticipated~     time on study treatment is 4 months and the target sample size is 150 individuals.~   "
77019|NCT02558868|"~     This study is a randomized, open-label, controlled study that will compare the efficacy of~     oxaliplatin in combination with irinotecan to irinotecan alone as second-line treatment for~     patients with gemcitabine and S-1 refractory pancreatic cancer.~   "
76842|NCT02561208|"~     Cervical cancer remains a serious health problem, particularly in developing countries. It is~     the leading cause of cancer death among women and mainly affects women of low socioeconomic~     status.~      Evidence has shown that HPV-test self-collection can reduce social and health services~     barriers to screening and increase coverage. However, high coverage will not result in a~     decrease of disease burden if women are not diagnosed/treated. The HPV-test indicates whether~     a woman is positive or not, and a triage test is needed to identify HPV-positive women who~     need to perform diagnostic procedures. Several triage methods are available. In Argentina,~     cytology is used as triage method; therefore, all HPV-positive women who have performed~     self—collection at home need to attend health centers to undergo cytology. However, the~     proportion of women who have completed triage is low, therefore new innovative strategies are~     needed to increase attendance to cytology of these women.~      This study will be carried out in Jujuy, one of the Argentinian provinces with highest~     cervical cancer mortality rates and where HPV- self-collection has been introduced as~     programmatic strategy for screening under-users.~      This trial is population-based cluster-randomized study that aims to evaluate the~     effectiveness of a mHealth intervention versus usual care to increase adherence to~     cytological triage among women with HPV-positive self-collected tests.~      An overall number of 240 Community Health Workers (CHWs) from the Primary Health Care System~     (PHCS) of the Province of Jujuy will be randomized into two groups:~        1. mHealth Intervention Group: Women with HPV self-collected tests will receive a mixed~          intervention which includes counseling through an interactive Apps specifically devised~          to increase adherence to triage which will be run on a tablet, and SMS text messages to~          remind them to attend triage. In addition, Heads of CHWs, chiefs of gynecology services~          and CHWs will receive reminders via e-mails and SMS message to contact women if after 60~          days from the HPV-results HPV+ they have not performed triage.~        2. Usual Care Group: Women with HPV self-collected tests receive usual care.~      A database built specifically for the study will be used; it will include data about~     randomization Group, agreement to participate in the study and socio-demographic data. Data~     on HPV-testing and triage will be uploaded importing the data from SITAM, using the Unique~     Identification Number (DNI).~      Data Analysis~      Effectiveness to enhance adherence to cytological triage: Adherence to triage will be~     considered for each CHW. This will be defined as the number of women with triage smears~     within 30, 60 and 90 days. There will be a comparison of the percentage of HPV-positive women~     that did the Pap test within those time intervals in the mHealth intervention group and the~     Usual Care group. The effect of the mHealth intervention against usual care will be estimated~     using a means difference test or a non-parametric test for independent samples.~   "
76843|NCT02561195|"~     This study will investigate a Clostridium difficile vaccine in healthy adults aged 65-85~     years. Each subject will initially receive 3 doses of vaccine on 1 of 2 vaccination~     schedules. The study will assess the safety and tolerability of the vaccine as well as the~     subjects' immune response to the vaccine. One year after the third dose subjects that did not~     receive placebo will be randomized to receive a fourth dose. Subjects will be followed for up~     to 4 years after their third vaccination.~   "
76844|NCT02561182|"~     The goal of this study is to determine whether or not patients with overgrowth syndromes have~     decreased bone density.~   "
76845|NCT02561169|"~     A multi-centre, randomized, placebo controlled, trial. Participants will be patients either~     ≥65 years or with one or more high risk conditions presenting to one of four academic~     emergency departments in Edmonton or Calgary with influenza-like illness. The investigators~     will test for influenza using a point-of-care rapid test and if positive for influenza~     participants will be randomized to oseltamivir or placebo and followed prospectively. The~     primary outcome will be hospitalization.~   "
76846|NCT02561156|"~     The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of~     TAK-653 when administered as single and multiple oral doses at escalating dose levels in~     healthy participants.~   "
76847|NCT02561143|"~     Investigators are evaluating the nutritional role of IAtta supplementation along with~     nutritional counselling in delaying the progression of cachexia to refractory cachexia in~     adult cancer Indian patients. Patients will receive IAtta (100 g) or whole wheat flour (100~     g) for daily consumption for 6 months. Dietary and physical activity counseling will be~     imparted every fortnight to patients.~      Nutritional, biochemical, quality of life and anthropometric estimations will be assessed at~     baseline, after 3 months and at 6 months of intervention for all patients.~      Investigators hypothesize that intake of nutrient rich bread mix IAtta (along with dietary~     and physical activity counselling) for six months will improve the health status and quality~     of life in free-living patients suffering from cancer cachexia.~   "
76848|NCT02561130|"~     The purpose of the study is to determine whether in patients with early type 2 diabetes, a~     short-term intensive metabolic intervention comprising Forxiga, metformin, basal insulin~     glargine and lifestyle approaches will be superior to standard diabetes therapy in achieving~     sustained diabetes remission.~   "
76849|NCT02561117|"~     The objective of this study is to determine whether administering once-daily doses of~     metronidazole, an intravenous (IV) antibiotic used to prevent infection in perforated~     appendicitis, is as effective in children as delivering it in the standard method of once~     every eight hours. Reducing the frequency of administration has the potential of decreasing~     personnel time and healthcare cost and increasing the lifespan of the IV line.~      To determine the effectiveness once-daily administration, a randomized controlled trial (RCT)~     will be conducted to compare outcomes between the two treatment schedules. We will recruit~     100 patients (50 per treatment) aged 5-18 being surgically treated for perforated~     appendicitis at the Children's Hospital of Eastern Ontario, who will be randomly assigned to~     one of the two treatment schedules. To compare the efficacy of the treatments, outcomes such~     as duration of hospital stay and theoretical cost will be measured and analyzed using~     statistical tests.~   "
76850|NCT02561104|"~     The study design will be a prospective study comparing laser-assisted cataract extraction~     cases and traditional manual phacoemulsification cases. All cases will be performed by~     faculty-supervised residents at Parkland Memorial Hospital. This study aims to examine visual~     acuity and complication rates in femtosecond laser-assisted cataract surgery compared to~     traditional manual phacoemulsification cataract surgery for the beginning surgeon. In~     addition, this study will assess the subjective novice surgeon experience and the patient~     experience in terms of expectations and results.~   "
76851|NCT02561091|"~     The purpose of this research study is to test the effectiveness and safety of the study drug,~     AM-111. AM-111 is tested for the treatment of sudden sensorineural hearing loss where the~     cause is unknown.~   "
76852|NCT02561078|"~     The main purpose of this study is to evaluate the efficacy and safety of the study drug known~     as human regular U-500 insulin (U-500R) administered by continuous subcutaneous insulin~     infusion (CSII) versus multiple daily injections (MDI) in participants with type 2 diabetes~     mellitus.~   "
76853|NCT02561065|"~     The main objective of TANSNIP-PESA is to determine in a population of asymptomatic bank~     employees with high and low imaging defined cardiovascular disease (CVD) risk the~     effectiveness of a comprehensive 3-year worksite-based lifestyle intervention consisting of~     12 personalized lifestyle counseling sessions, a Fitbit physical activity tracker and a~     sit-stand Workstation.~   "
77020|NCT02558855|"~     The primary aim of this study is to examine how different physical therapy interventions~     affect the resting state and contraction state of a certain abdominal muscle in patients with~     low back pain.~   "
76855|NCT02561026|"~     Frozen plasma (FP) is commonly transfused to patients with abnormal coagulation results prior~     to medical procedures associated with a risk of bleeding (e.g. involving a needle or~     incision). The most frequent group that requires FP transfusions are patients admitted to an~     intensive care unit. These patients frequently have abnormal coagulation tests and also~     frequently require invasive medical procedures that can be associated with bleeding. While FP~     transfusions can improve abnormal coagulation test results, there is no evidence to suggest~     that prophylactic FP transfusions will reduce bleeding associated with medical procedures in~     patients with mild coagulation abnormalities. Additionally, it is known that important~     adverse complications occur with FP transfusions.~      The investigators will undertake a pilot randomized controlled trial in non-bleeding ICU~     patients who require an invasive medical procedure (central venous catheterization, chest~     tube, thoracocentesis, paracentesis, biopsy, fluid drainage) in 3 Canadian hospitals.~     Patients with an abnormal coagulation test (INR between 1.5 to 2.5) will receive a FP~     transfusion or no treatment prior to an invasive procedure.~      The primary outcome for this pilot study will be feasibility (the number of patients enrolled~     per month). Other important outcomes will include those that will be evaluated in the~     definitive trial including bleeding post procedure, red cell transfusions, adverse~     transfusion reactions, mortality and hospital length of stay.~      The objective of the study is to enrol 80 patients over 2 years in 3 Canadian hospitals.~   "
76856|NCT02561013|"~     The purpose of this study is to evaluate the product performance of a new adjustable~     compression system for the treatment of venous leg ulcers.~   "
76857|NCT02561000|"~     The object of the study is to determine whether different doses of PZ-128, when added to~     standard medical care in persons undergoing cardiac catheterization/percutaneous coronary~     intervention, will increase the risk of bleeding.~      A secondary objective is to determine whether patients treated with PZ-128 have fewer cardiac~     events such as heart attack, bypass surgery or stroke compared with those persons treated~     with the standard of care.~   "
76858|NCT02560974|"~     This study will compare capecitabine/oxaliplatin as adjuvant chemotherapy versus observation~     alone in chemotherapy-naive participants who have undergone potentially curative resection~     for gastric cancer. Participants will be randomized to either the chemotherapy arm or the~     observation arm. Capecitabine will be administered orally, 1000 milligrams per meter-squared~     (mg/m^2) twice daily (BID) on Days 1 to 15 of a 3-week cycle, for 8 cycles, and oxaliplatin~     will be administered as an intravenous (IV) infusion, 130 mg/m^2 every 3 weeks for 8 cycles.~     The anticipated time on study treatment in 6 months and the target sample size is 1024~     individuals.~   "
76859|NCT02560961|"~     Introduction: Kinesio taping consists of the attachment of a thin elastic tape over specific~     muscles, the thickness of which is similar to that of the epidermis. This tape can be~     stretched to 140% of its original length, which demonstrates greater elasticity in comparison~     to conventional bandages. According to the creator of this method, Kinesio taping leads to~     better muscle activation or inhibition, reduces pain, swelling and muscle spasms and prevents~     muscle injury. Objective: The aim of the proposed study is to compare and analyze the~     immediate effect of Kinesio taping and placebo taping on performance during unilateral~     vertical jump and two hop tests by young professional soccer players. Methods: A randomized,~     placebo-controlled, double-blind, clinical trial will be conducted involving 100 athletes.~     The volunteers will be submitted to an evaluation of the dominant lower limb using the Single~     Leg Hop Test and Single Leg Triple Hop Test as well as the evaluation of a unilateral~     vertical jump on a pressure platform. The athletes will then be randomly allocated to two~     groups. Group A will receive Kinesio taping of the triceps surae muscle as described by Kase~     (2003, 2013) and Group B will receive a placebo taping of the same muscle. After 30 minutes,~     the volunteers will be submitted to the same evaluation tests. Analysis: Intra-group and~     inter-group analyses of the results will be performed. Statistical tests will be conducted~     considering a 5% significance level.~   "
76860|NCT02560948|"~     gpASIT+TM product is based on highly purified allergen fragments obtained from grass pollen.~     The purpose of this study is to demonstrate the clinical efficacy and safety of a~     subcutaneous immunotherapy with gpASIT+™ in patients with grass pollen-induced allergic~     rhinoconjunctivitis compared to placebo.~   "
76861|NCT02560935|"~     The overall goal of this proposal is to conduct a partial double-blind randomized Phase III~     clinical trial for primary stroke prevention in children with sickle cell anemia (SCA) in~     sub-Saharan Africa.~   "
76862|NCT02560922|"~     This study will examine the effectiveness of an 11-session, culturally enhanced,~     telephone-based pain coping skills training program among African Americans with hip or knee~     OA. The study team will enroll n=248 African Americans with hip or knee OA. The participants~     will be randomized into two groups. One group will take part in an 11-week pain CST~     intervention. The other group will be a wait list that receives the pain CST program after~     completing all follow-up study measures. All study participants will be able to continue any~     other usual medical care for their OA during the study period. The pain CST intervention~     includes 11 individual sessions with a study counselor, delivered via telephone to enhance~     access and reach. The sessions include the following: general information about why pain~     coping skills training is important, training in specific pain coping skills (such as~     progressive muscle relaxation, communication, imagery, and activity pacing), and guided~     practice with each skill. The CST program will also include information about other behaviors~     important for OA, such as physical activity and weight management. The main study outcome~     will be the pain subscale of the Western Ontario and McMasters Universities Osteoarthritis~     Index (WOMAC). Other outcomes will include the WOMAC function subscale, Coping Strategies~     Questionnaire, Arthritis Self Efficacy Scale, depressive symptoms, Health-Related Quality of~     Life, and Patient Global Impression of Change.~   "
76863|NCT02560909|"~     Influenza virus is an important cause of morbidity in the transplant population and can lead~     to viral and bacterial pneumonia. Although the annual influenza vaccine is recommended for~     transplant patients, studies have shown that nonadjuvanted vaccine has poor immunogenicity.~     There are no studies that define the effect of adjuvanted vaccine in this population. The~     purpose of this study is to determine if a vaccination with FLUAD® results in improved~     immunogenicity as compared to standard vaccine in allo-HSCT recipients. Immunogenicity will~     be assessed by standard quantitative antibody titer assessments and using cell-mediated~     immunity measurements.~   "
76864|NCT02560896|"~     Currently, there is no clear legal or ethical guidance about how researchers and IRBs ought~     to proceed when the research participant in a biobank is deceased and there is clinically~     relevant information that could be disclosed to family members. This study is designed to~     test a procedure offering genetic information to family members of research participants who~     participated in a pancreatic cancer biobank in a Health Insurance Portability and~     Accountability Act (HIPAA) -compliant design.~   "
76865|NCT02560883|"~     The overall objective is to develop a clinical data registry that can be used to facilitate~     research with the ultimate goal of reducing the morbidity and/or mortality and improving the~     quality of life of patients diagnosed or living with hairy cell leukemia. With approximately~     600 new cases of this rare disease identified in the US each year, HCL represents 2% of all~     cases of leukemia in adults. Considering the rarity of this chronic leukemia, the Hairy Cell~     Leukemia Foundation (HCLF), in partnership with investigators from its Centers of Excellence,~     seeks to develop a registry to help researchers identify new trends in outcomes, recognize~     the most effective treatments, discover previously unknown complications of the disease, and~     design clinical trials for new therapies.~   "
76866|NCT02560870|"~     Aim: To compare the efficacy of Aloe Vera and non-alcoholic chlorhexidine mouthwash in the~     treatment of Periodontal diseases.~      Methods &Material: 32 patients were selected, the following periodontal parameters were~     recorded at baseline, and after recording all the parameters at the baseline, Scaling, root~     planning, and polishing are done for all the patients participating in the study. Oral~     hygiene instructions were given that included brushing twice a day with a soft brush, After 2~     weeks, patients in the study, were randomly (Balanced Block Randomization) equal divided into~     2 groups;~      Group A: mouthwash aloe Vera (Alodent Co. UK) for each patient, Group B: Non-alcoholic~     Chlorhexidine (Perio-Kin, Livar CO. Spain) 10 ml by patients routinely washed two times in~     one day for about 30 seconds and lasts for 15 days, then every 7 days periodontal parameters,~     and at the end of 2 weeks (days 0, 7, 15) clinical changes are evaluated.~   "
76867|NCT02560857|"~     The study will prospectively determine the clinical utility of non-pathogen specific cellular~     immunity assessment using the Quantiferon-Monitor to quantify the degree of~     immunosuppression. The investigators will use the results of the assay to predict whether~     patients develop opportunistic infections and predict organ rejection.~   "
76868|NCT02560844|"~     This study will evaluate the prognostic utility of novel ECG markers of electrical~     instability in patients with cardiomyopathy.~   "
76869|NCT02560831|"~     Knee Osteoarthritis is a degenerative disease associated with muscle weakness, arthralgia,~     rigidity and postural instability. Therapeutic exercise can reduce pain and improve muscle~     strength and postural balance, however benefits from association with pompage is not known.~     This study aims to evaluate the effects of therapeutic exercise on pain, muscle strength and~     postural balance in elderly women with knee osteoarthritis. Methodology: Almost randomized~     controlled trial, in which were included elderly between 60 and 80 years diagnosed with knee~     osteoarthritis, randomized into two groups with 11 participants each. Intervention group held~     strengthening exercises for flexors and knee extensors, balance training, and manual knee~     pompage for 12 weeks. Control Group received educational lectures. Arthralgia was estimated~     by pain subscale of the questionnaire Western Ontario McMaster Universities Osteoarthritis~     Index and (WOMAC); muscle strength was assessed by the isokinetic dynamometer HUMAC® NORM~     Testing & Rehabilitation System and the postural balance by the Biodex Balance SD postural~     stability protocol (Biodex Medical Systems, Inc. New York, USA). The Student t test was used~     for statistical analysis.~   "
76870|NCT02560818|"~     This is a case-control study of molecular diagnostics.~      This study requires two steps:~        -  The first part of the study will be conducted on a population of 10 women without breast~          cancer and, or ovarian family (Healthy Volunteers controls)~        -  The second part of the study will be conducted on a population of 50 patients~          predisposed to familial breast and, or ovarian cancer compared to 10 controls .~      For analysis of leucocytes of the patients, a blood sample collected in a prior study (EXSAL~     study, ID-RCB 2009-A00833-54) will be used.~   "
76871|NCT02560805|"~     The purpose of this study is to find out why patients with post-traumatic stress disorder~     (PTSD) have an increased risk for heart disease and high blood pressure later in life. A~     second purpose is to find out what causes PTSD patients to have high adrenaline levels during~     stress. This study will also test if a medicine called losartan improves high adrenaline~     levels in patients with PTSD and if a certain gene that has to do with high blood pressure~     might be associated with high adrenaline levels.~   "
76872|NCT02560792|"~     The primary goal of this study is to determine experimentally the relationship between~     affective response to exercise and future exercise behavior. A secondary goal is to examine~     potential mediators and moderators of this relationship, specifically four variables~     considered to contribute to the volitional control of exercise behavior - planning,~     attention, resource commitment, and affect regulation. An additional goal is to examine how~     symptoms of depression might influence the affective response to exercise, and the~     relationship between affective response to exercise and exercise behavior.~   "
76873|NCT02560779|"~     The purpose of the phase 1b portion is to evaluate safety and tolerability and determine a~     recommended phase 2 dose for TRC105 when added to standard dose sorafenib in patients with~     hepatocellular carcinoma. Up to 18 patients will be treated.~      The purpose of the phase 2 portion is to estimate the ORR of patients with hepatocellular~     carcinoma by RECIST 1.1. Up to 21 patients will be treated in phase 2.~   "
76874|NCT02560766|"~     The primary objective of the trial is to evaluate the efficacy of HORIZANT 300 mg and 600 mg,~     compared to placebo, at 12 weeks of treatment, for the treatment of Restless Legs Syndrome~     (RLS) in adolescents (13 to 17 years of age) diagnosed with moderate-to-severe primary RLS.~   "
76875|NCT02560753|"~     The study is a randomized, parallel, 4-dose design in subjects with mild-to-moderate~     Alzheimer's Disease. Subjects will be randomized to one of 4 doses of T3D-959. Subjects will~     be evaluated for changes from baseline in cerebral metabolic rate of glucose (FDG-PET~     imaging), functional connectivity of the hippocampus (BOLD-fMRI), and cognitive function~     (ADAS-Cog11 and DSST) as well as assessed for safety and tolerability to T3D-959.~      An expanded access extension is planed to provide access to study medication to subjects who~     have completed the main study and requested continued use.~   "
76876|NCT02560740|"~     Chemotherapy-induced peripheral neuropathy (CIPN) is a progressive, enduring, and often~     irreversible condition featuring pain, numbness, tingling and sensitivity to cold in the~     hands and feet (sometimes progressing to the arms and legs) that afflicts between 30 and 40~     percent of patients undergoing chemotherapy.~      American Society of Clinical Oncology (ASCO) guidance on The Journal of Clinical Oncology~     (JCO, 2014 April 14) does not recommend any prophylaxis regimen for CIPN.~      PerOx Quench has unique membrane protection and anti-oxidative function as a special food,~     that's why to try to explore its preventive effects on CIPN prevention induced by Oxaliplatin~     for colorectal cancer or gastric cancer chemotherapy.~   "
76877|NCT02560727|"~     No technique by placing a tube through anus into cecum for whole colon administration. This~     study aimed to evaluate the feasibility, safety, and efficacy of transendoscopic enteral~     tubing (TET) in fecal microbiota transplantation (FMT) through whole colon.~   "
76878|NCT02560714|"~     The purpose of the SI Joint Fusion and Decortication Using the SImmetry System study is to~     evaluate the SImmetry Sacroiliac Joint Fusion System for fusion of the SI joint and relief of~     SI joint pain symptoms.~   "
76879|NCT02560701|"~     Using eleven years (2004-2014) of claims data from the largest US commercial health insurer,~     the investigators will assess the impact of switching into high-deductible health plans~     (HDHPs) on outcomes for patients with bipolar disorder. Patient subgroups will include~     patients with and without high medication cost-sharing and vulnerable populations~     (racial/ethnic minorities, poor, rural, major comorbidities). Interviews with patients and~     caregivers recruited through a major advocacy group will provide further insights into the~     policy issues with real-life experiences.~   "
76880|NCT02560688|"~     This study is being conducted to test the hypothesis that coadministration of clopidogrel~     with DS-1040b will be safe and well tolerated. Subjects entering the study will initially~     receive a single 12 hour infusion of DS-1040b, to generate data on the effect of DS-1040b~     alone. After a wash-out period (to ensure that no DS-1040b is left in the blood) subjects~     will receive repeated clopidogrel doses over 5 days to generate data on the effect of~     clopidogrel alone. On the sixth day subjects will receive both DS-1040b and clopidogrel, and~     the effects will be compared to when the two treatments were given alone.~   "
76881|NCT02560675|"~     Why does acute post whiplash injury pain transform into chronic pain? Multi-modal assessment~     of risk factors and predictors of pain chronification~   "
76882|NCT02560662|"~     The purpose of this study is to investigate whether a training program with intensified~     physical exercise prior to and after surgery for breast cancer enhances postoperative~     recovery.~   "
76883|NCT02560649|"~     The aim of current study is to investigate whether the HBsAg clearance rate can be improved~     if applying RGT((Response-Guided Therapy) strategy in HBeAg positive CHB(chronic hepatitis B)~     patients treated by nucleoside analogue(NUC) achieved HBVDNA<1000copies/ml，and~     HBsAg<5000IU/ml; &HBeAg<100PEIU/ml (or470s/co), combined with PEG-IFN a-2a for 24 weeks.~   "
76884|NCT02560636|"~     PLUMMB is an phase I trial to investigate the safety, tolerability and effectiveness of an~     immunotherapy drug called Pembrolizumab used in combination with radiotherapy. The study will~     also investigate two different doses of pembrolizumab, starting at 100mg (through an~     intravenous drip) and increasing to 200mg for the next cohort of patients, if the first dose~     is well tolerated. The patients suitable for this study will be: Group A those with locally~     advanced bladder cancer or Group B patients whose cancer has spread from the bladder~     (metastatic bladder cancer).~      Treatment in the PLUMMB trial will start with a pembrolizumab 2 weeks prior to starting a~     course of 6 weeks radiotherapy. Treatment with pembrolizumab will then be given every three~     weeks. Patients in Group A will then continue to take pembrolizumab for up to a year unless~     they have disease progression or unacceptable side effects in the meantime. Patients in Group~     B will continue taking pembrolizumab for as long as needed until they have disease~     progression or unacceptable side effects.~      Patients will be seen every 3 weeks during treatment and every 3-6 months thereafter. CT~     scans will be done every 3 months during treatment and as per usual care (usually 6 monthly)~     after the treatment has finished. Patients in Group A will also have a cystoscopy (camera~     test) to look into the bladder 3 months after they finish radiotherapy. This is standard care~     and would be the same for patients not on a research study.~   "
76885|NCT02560623|"~     This study will evaluate if the capsule sponge device can detect the presence of Barrett's~     Esophagus~   "
76886|NCT02560610|"~     The aim is to study the effect of OC000459 on eosinophilic airway inflammation and asthma~     control in subjects with severe, refractory eosinophilic asthma.~   "
76887|NCT02560597|"~     The purpose of this study is to assess the effects of repetitive transcranial magnetic~     stimulation (rTMS) as a treatment for Epilepsia Partialis Continua (EPC) or refractory Status~     Epilepticus (SE), when standard clinical treatments have failed.~   "
76888|NCT02560584|"~     The purpose of this study is to investigate if blue light cystoscopy with Cysview improves~     detection of tumors in patients with bladder cancer during surveillance cystoscopy, using the~     KARL STORZ D-Light C PDD Flexible Videoscope System. Another purpose is to investigate if~     Cysview and blue light is safe and effective when used repeatedly.~   "
76889|NCT02560571|"~     The study evaluates pre-operative prediction of the risk for lymph nodes involvement in~     endometrial cancer patients. Patients will undergo ultrasound exam (bi and three dimensional)~     and biomarker test - Ca 125, in addition to routine physical and laboratory exams, before~     surgery.~      The sonographic evaluation will include endometrial characteristics and myometrial invasion,~     pelvic findings and enlarged lymph nodes.~   "
76890|NCT02560558|"~     The purpose of this study is to transition patients who have been stable on Belatacept for~     one year after kidney transplant from standard 4-week to an investigational 8-week belatacept~     dosing schedule. The investigators hypothesize that renal function and acute rejection rates~     will be non-inferior with 8-week belatacept dosing.~   "
76900|NCT02560428|"~     The purpose of this study is to evaluate approximately eight grants that will test~     interventions to improve cardiovascular disease prevention. The investigators will collect~     and analyze qualitative data to identify the most effective combinations of intervention~     strategies. The investigators will observe grantees and selected practices to understand why~     and how those combinations are effective. The investigators will also gather data from the~     grantees to assess how effective the interventions are.~   "
76891|NCT02560545|"~     Effective treatment of acute pain, chronic and persistent is the most important concern in~     the world today. Although a variety of pain medications including anti-inflammatory~     painkillers and opiouids, patients continue to suffer from pain constantly. For over a~     century ,International committees studied the issue of cannabis, and almost uniformly~     recommended the use of cannabis for various medical applications ,especially those that~     include pain treatment.~      Despite the widespread use of THC in clinical practice, there are few studies on the efficacy~     of THC In a double-blind, randomized trial. In addition, few studies examined the effect of~     THC on the experience pain in healthy subjects and most of them did not find an effect on~     pain experimental induced by capsain. so checking other models of pain such as thermal pain~     and mechanical pain in addition to checking the influence on the regulation of pain will~     contribute to understanding the mechanism of action of THC. Understanding the mechanism of~     action of THC in relieving pain will lead to predicting who will benefit from this treatment~     and direct patients for selection of appropriate medication according to the damaged~     mechanism.~   "
76892|NCT02560532|"~     The purpose of this study is to evaluate the safety and potential therapeutic benefit of use~     of clazosentan in reversing cerebral vasospasm (a narrowing of blood vessels in the brain due~     to the presence of blood in the space around the brain) in patients who have suffered a~     condition known as aneurysmal subarachnoid hemorrhage caused by bleeding onto the surface of~     the brain from a ruptured brain aneurysm~   "
76893|NCT02560519|"~     Colloid solutions are widely used for volume replacement therapy because of their high~     oncotic pressure, which could reduce interstitial fluid shifting. Human albumin is the only~     colloid solution of biologic origin with a molecular weight of 60 kDa. As the most abundant~     plasma protein, it has physiological importance in the well-being of the endothelial~     glycocalyx. Older studies in septic patients, however, did not show any benefit of albumin~     over saline solution. Crystalloid solutions, such as Ringer's acetate, do not impair neither~     renal function nor coagulation, but their volume expanding effect is questionable.~      For several reasons (use of heart-lung machine, systemic inflammation, coagulation~     disturbances), patients undergoing cardiac surgery need especially large amounts of fluids.~     However, there are no large trials comparing albumin solutions to crystalloid solutions~     cardiac surgery.~      This double-blinded trial will randomize according to a power analysis 1250 cardiac surgery~     patients (=625+625) at Meilahti hospital to use either 4% Albumin or Ringer's acetate~     solutions for both priming of the heart-lung machine and perioperative volume replacement~     therapy. The primary efficacy and safety endpoint of this study is the incidence of major~     adverse events (MAE), defined as a composite endpoint of all-cause mortality, acute~     myocardial infarction, acute heart failure or low output syndrome, resternotomy, stroke,~     certain arrhythmias, major bleeding, infections compromising post-procedural rehabilitation,~     acute kidney injury within 90 days postoperatively. The secondary outcomes are total number~     of MAEs, major adverse cardiac events (MACE), perioperative fluid balance, blood product~     transfusions, blood loss, acute kidney injury, days alive without mechanical~     ventilation/outside ICU/at home in 90 days as well as 90-day mortality. Blood samples for~     biochemical analyses will be collected at four perioperative time points.~      This trial will provide data about efficacy and safety of 4% albumin in cardiac surgery~     patients. The biochemical mechanisms of albumin will be assessed.~   "
76894|NCT02560506|"~     The goals of this Model System Program are to expand upon and advance the findings and~     outcomes of previous and current Model Systems clinical research, to continue to develop and~     study the effectiveness of innovative treatment strategies for persons with spinal cord~     injury (SCI); and to evaluate the benefits of a well-designed, comprehensive, coordinated,~     interdisciplinary continuum of care that lead to improved outcomes for all persons with SCI.~     In order to achieve these goals, the following objectives of the Midwest Regional Spinal Cord~     Injury Care System (MRSCICS) model system grant proposal will be accomplished.~   "
76895|NCT02560493|"~     The goal of the proposed randomized controlled trial is to test the efficacy of exergaming~     (i.e. video gaming that involves physical activity) to reduce adiposity in overweight and~     obese children.~   "
76896|NCT02560480|"~     The prevalence of acute and chronic groin injuries in athletes is between 5 and 10 %. This~     observational case-control study follows three contact sport teams (soccer, ice-hockey and~     bandy) for two years to find out the prevalence and reasons for groin pain. Clinical~     examination, pain scores and pelvic magnetic resonance imaging (MRI) are performed. Hip and~     groin questionnaire (HAGOS) is used to determine severity of groin injuries.~   "
76897|NCT02560467|"~     The objective of this study is to determine whether myocardial contrast echocardiography in~     patients with cardiomyopathy (HCM) can detect resting hypo-perfusion due to fibrosis or~     stress induced perfusion defects due to associated abnormalities in intramyocardial arteries~     and the microcirculation. A secondary aim will be to determine whether abnormalities in~     perfusion are associated with either severity of symptoms (chest pain and dyspnea), presence~     of arrhythmias, and regional function of the septum.~   "
76898|NCT02560454|"~     ADHD is associated with cognitive deficit. Therefore, cognitive training is often proposed as~     an intervention for ADHD that targets cognitive deficits, with specific exercises through~     intensive training sessions. This intervention is based on principles of brain plasticity and~     cerebral functional reorganizations.~      Working memory deficits constitute a key impairment in ADHD. That is why, Cogmed working~     memory training is the most commonly used and studied cognitive training program in clinical~     practice and research. It is clear from most studies that Cogmed training program increases~     working memory in ADHD. However, transfer of learning is not demonstrated on: other cognitive~     functions that are not targeted by the program, on ADHD symptoms, nor on academic~     achievement.~      In addition to this type of intervention multi-factorial program targeting different~     cognitive function as Presco also exist but have been less studied.~      To address these challenges, this study will follow a randomized and controlled design.~      The main objective of this study is to examine the impact of cognitive training in comparison~     with a control waiting-list group among children with ADHD on:~        1. ADHD symptoms,~        2. cognitive functioning,~        3. attentional capacities~        4. academic achievement.~      The second objective is to compare two types of cognitive training a unifactorial program~     Cogmed targeting working memory and a multifactorial Presco focusing on different cognitive~     functions affected by ADHD.~      Long-term effects are examined six months after training. Participants (n=90) will be~     randomly assigned to the two experimental group (Cogmed or Presco) or to the control group~     waiting list. Participants will be evaluated three time (time 1) just before the~     intervention, (time 2) six weeks after the first evaluation, immediately after the~     intervention and (time 3) six months after the intervention.~   "
76899|NCT02560441|"~     The first Part: recruiting untreated ENKL patients with extensive stage I or limited stage II~     disease (only referring to patients with the invasion of Waldeyer's ring and cervical lymph~     nodes) . Patients are randomly divided into two arms, IPGDP regimen chemotherapy followed by~     radiotherapy or radiotherapy followed by IPGDP regimen chemotherapy. IPGDP regimen for both~     arms are 3 cycles. And the chemotherapy is repeated every 3 weeks..~      The second part: recruiting extensive stage II ,stage III-IV, relapsed or refractory ENKL~     patients. Patients receive 6 cycles of IPGDP regimen chemotherapy. And the chemotherapy is~     repeated every 3 weeks.~   "
76913|NCT02560259|"~     The role of referred pain from the retro trochanteric region, in patients with knee pain.~     Defining and quantifying this sub group of knee patients in the investigators list of refered~     knee patients. Evaluating the effect of treatment. A randomized trial.~   "
76901|NCT02560415|"~     To meet the required intensive intervention hour for treating children with autism spectrum~     disorder (ASD), the investigators developed an automated serious gaming platform (11 games)~     to deliver intensive intervention at home (GOLIAH). The major objective of the study is to~     test GOLIAH during a 6-month matched controlled exploratory study were to assess (1) the~     usefulness and acceptability of the gaming platform; (2) how experimental children performed~     using the different Imitation and JA games; and (3) whether children from the experimental~     group improved significantly more than children treated as usual (control group).~   "
76902|NCT02560402|"~     Aim of the present study is to determine whether~        1. RRI can predict glomerular hyperfiltration;~        2. glomerular hyperfiltration is associated with low renal resistive index;~        3. glomerular hyperfiltration/low RRI are associated with accelerated flow in the~          sublingual microcirculation;~        4. glomerular hyperfiltration/low RRI are related to fluid status as quantified with~          bioimpedance analysis.~   "
76903|NCT02560389|"~     The purpose of this study is to investigate a new use for a medication called levodopa~     (L-DOPA). L-DOPA has been approved for use in Parkinson 's disease, but not for Posttraumatic~     Stress Disorder (PTSD). L-DOPA is thought to enhance certain cognitive abilities that the~     investigators believe may be affected among women with PTSD. It is hypothesized that L-DOPA~     may enhance fear extinction learning to a conditioned fear stimulus. If this is true, L-DOPA~     may improve outcomes for those undergoing certain types of therapy for PTSD, though that aim~     is beyond the scope of this project. Additionally, the investigators are testing whether an~     individual's genetic profile affects how well L-DOPA works to enhance cognitive abilities.~   "
76904|NCT02560376|"~     This is an open-label positron emission tomography/computed tomography (PET/CT) study to~     investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-exendin-4 in~     insulinoma and nesidioblastosis patients. A single dose of 55.5-111 Mega-Becquerel (MBq)~     68Ga-NOTA-exendin-4 will be injected intravenously. Visual and semiquantitative method will~     be used to assess the PET/CT images.~   "
76905|NCT02560363|"~     This is an open-label, randomized, cross over single oral dose study to compare the~     pharmacokinetics of different formulations of AZD9977 in Part A and the influence of food in~     Part B in healthy male subjects~   "
76906|NCT02560350|"~     Human adipose tissues were obtained from five healthy adult women who underwent abdominal~     liposuction. They were aged 28 to 45 years (mean, 32.15±4.8 years) and had no infectious or~     endocrine diseases. Ten millilitres of discarded adipose tissue from the humans was used to~     gain the adipose-derived stem cells. In this study, the investigators will evaluate the~     potential of a small intestinal submucosa scaffold combined with adipose-derived stem cells~     to form an adipocyte-containing hypodermis.~   "
76907|NCT02560337|"~     Many ovarian cancer patients have been offered different standard cytostatics and gradually~     develop chemo-resistance. However, a considerable fraction of these patients are still in~     good general health and have a strong wish for further treatment.~      Cabazitaxel (Jevtana®) is a new taxane with effect in breast and prostatic cancer. In both~     tumors it has shown effect in patients refractory to docetaxel. Therefore, it could be~     anticipated that cabazitaxel may also have an effect in chemo-resistant ovarian cancer.~      Tocotrienol is a fraction of the natural E-vitamin with several biological effects, including~     effect on malignant cells and angiogenesis.~      The aim of the study is to investigate whether cabazitaxel and tocotrienol could be~     reasonable treatment options in patients with chemo-resistant and refractory ovarian cancer~     with regard to effect and toxicity.~      In case of progression on cabazitaxel there is an option of crossing over to tocotrienol and~     vice versa.~   "
76908|NCT02560324|"~     This is a randomized, double-blind, placebo-controlled crossover study to test whether a~     medication called ramelteon (Brand Name: Remeron) will help smokers quit and whether it~     reduces sleep problems that smokers experience during a quit attempt.~   "
76909|NCT02560311|"~     The aim of this study is to analyze cases of human epidermal growth factor receptor (HER)~     2-positive metastatic breast cancer (MBC) of the last 10 years at the University Hospital of~     Zurich to assess the efficacy of the treatment with trastuzumab in HER2-positive MBC and to~     find out associations between different variables and the outcome. The aim is to find out~     probable prognostic factors and patterns of disease progression. Prognostic factors could~     optimize treatment approaches and result in a delay of disease progression.~   "
76910|NCT02560298|"~     This randomized phase II trial studies how well cisplatin and fluorouracil work compared with~     carboplatin and paclitaxel in treating patients with anal cancer that cannot be removed by~     surgery, has come back at or near the same place as the primary tumor, or spread to other~     places in the body. Drugs used in chemotherapy, such as cisplatin, fluorouracil, carboplatin~     and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet~     known whether cisplatin and fluorouracil are more effective than carboplatin and paclitaxel~     in treating anal cancer.~   "
76911|NCT02560285|"~     Over time there is a need to improve old and develop new risk models. Overall the assessment~     of mortality risk in cardiac surgery is performed with the use of preoperative risk models.~     The use of improved risk models and increased accuracy in the technique of preparing these~     mathematical systems does not have a positive impact on the level of prediction, which is~     still inaccurate, especially in the considered group of high risk. New models need to be~     built not only for a better prediction of mortality risk, if not also to predict morbidity in~     the group of patients at higher risk of complications after cardiac surgery procedures.~      The aim of this study is:~        -  To construct the HiriSCORE to identify patients at higher risk of complications after~          cardiac surgery procedures~        -  Assessing the impact of pre-, intra- and postoperative period to the prognosis of~          morbidity and mortality in high-risk patients undergoing cardiac surgery procedures.~   "
76912|NCT02560272|"~     The study will evaluate the safety and immunogenicity of a haemophilus influenzae type b~     conjugate vaccine (Hib) in Healthy Children 2 Months to 5 Years of Age who have not been~     previously immunized with a Hib vaccine. Children 2 to 5 months of age will receive 3 doses~     of Hib vaccine, Children 6 to 11 months of age will receive 2 doses of Hib vaccine, Children~     1 to 5 years of age will receive 1 dose of Hib vaccine, with each dose given approximately 1~     month apart.~   "
76918|NCT02560194|"~     Guaiac faecal occult blood testing (gFOBT) consistently demonstrates reductions in deaths~     from colorectal cancer of around 16% and gFOBT screening is now routine in all four countries~     of the United Kingdom. However, gFOBT has significant limitations and is associated with a~     substantial interval cancer rate in the region of 50 %, indicating a severe deficiency in~     sensitivity for cancer. Additionally, as the majority of colorectal cancers arise from~     pre-existing adenomas, it is important for colorectal screening programmes to detect adenomas~     in order to reduce the incidence of the disease as well as the associated mortality. Although~     gFOBT does detect some adenomas, most randomised trials have not demonstrated a reduction in~     colorectal cancer incidence. Also, FOBT screening tends to under-detect cancers in women and~     it is relatively insensitive for rectal cancer when compared with colon cancer.~      Single flexible sigmoidoscopy (FS), between the ages of 55 and 65 years, has been shown to~     bring about a significant reduction in colorectal cancer mortality. In addition, and most~     importantly, after a period of four years a significant reduction in colorectal cancer~     incidence was observed. FS does not suffer from low specificity since false positives do not~     occur, and there is independent evidence that it is more sensitive than a single gFOBT. In~     addition, FS is ideally suited to detecting rectal cancers and adenomas, and it is unlikely~     that there would be a gender difference in the sensitivity.~      Single FS has not been compared with biennial FOBT and there is no information regarding the~     utility of FS in a population that has already been exposed to FOBT screening. It is~     hypothesised that offering a combination of gFOBT and FS would provide an enhanced screening~     algorithm that would be associated with better outcomes than gFOBT alone. In order to test~     this hypothesis a randomised evaluation pilot study of FS screening integrated into the~     current gFOBT Screening Programme, will be carried out in those around age 60, as this~     appears to be the age at which adenoma prevalence peaks.~   "
76919|NCT02560181|"~     Radiation therapy is considered a standard treatment option for the management of localized~     prostate cancer. Among the 20-30% of patients who recur, there is no consensus on the optimal~     salvage therapy. Salvage options available for isolated local recurrence include; temporary~     or permanent implantation of radioactive seeds into the prostate, complete removal of the~     prostate gland, use of low temperatures to treat the disease (cryotherapy), and high~     frequency ultrasound to treat the disease. There are risks of complications associated with~     all these treatments, and there is presently no consensus as to which treatment is the best.~     The aim of this pilot study is to look at the feasibility and toxicities of whole gland~     salvage treatment of the prostate using temporary implantation of radioactive seeds into the~     prostate.~   "
76920|NCT02560168|"~     1. The MyoVista device is capable of detecting surface electrocardiogram signals and~          sensitive in detecting coronary artery disease compared to traditional computed~          tomography angiography (CTA)~        2. Electrophysiological signals at the cellular level of myocardium are related to specific~          patterns on the MyoVista device~        3. Changes in MyoVista device output and can indicative of future CAD outcomes and need for~          revascularization~   "
76921|NCT02560155|"~     Surgical site infections are a major postoperative complication and are mostly due to~     colonization with endogenous germs, like Staphylococcus aureus, Staphylococcus epidermidis or~     Propionibacterium acnes. In literature, preoperative decolonization procedures showed a trend~     in lowering surgical site infection rates, but especially in orthopedic surgery data is~     controversial and randomized controlled trials are lacking. In the main study, the study~     investigators aim at performing a controlled prospective randomized interventional trial to~     measure the impact of preoperative decolonization of nasal Staphylococcus aureus carriers on~     surgical site infection rates in orthopedic surgery. In an alongside study a controlled~     prospective randomized interventional trial to measure the impact of preoperative skin~     decolonization of patients undergoing an orthopedic procedure will be conducted.~   "
76922|NCT02560142|"~     This is a single center non-interventional study in healthy participants for behavioral~     assessment and fMRI assessments. The study will consist of 2 parts. Part A will involve 5~     participants and will study the implementation of the behavioral tests and identify potential~     issues. Part B will involve 30 participants and will study the test-retest reliability.~     Duration of participation for each participant will be 30 days for Part A (28 days screening~     period and 2 days of study visit) and 48 days for Part B (28 days screening period and 2~     study visits of 2 days each separated by a period of 14 days).~   "
76923|NCT02560129|"~     Summary: Emerging data demonstrate long-term morbidity and mortality in those who survive~     critical illness. However, there is no data regarding long-term follow-up for ICU survivors.~     The investigators have begun the implementation of an ICU recovery clinic.~      Rationale:~      ICU survivors are at high risk for functional, cognitive and psychiatric impairments.~     However, methods to mitigate these impairments and improve recovery are lacking. Special~     follow-up clinics for survivors of critical illness have been proposed and implemented to~     some degree, but are uncommon.~   "
76924|NCT02560116|"~     The investigators aim to correlate noninvasive pulmonary artery systolic pressure (PASP)~     measurements obtained with and without echocardiographic contrast (Optison) during~     transthoracic echocardiography (TTE) with those obtained invasively and simultaneously during~     right heart catheterization, as the gold standard.~   "
76925|NCT02560103|"~     Observational study to investigate circadian rhythm patterns~   "
76926|NCT02560090|"~     Bamberg County residents who has been diagnosed with or is at high risk for diabetes, may be~     eligible for a clinical research study to improve diabetes self-management and decrease~     hospital re-admissions.~      The purpose of this study is to compare the effectiveness of three hospital discharge~     follow-up methods:~        1. standard of care,~        2. a nurse telephone intervention (care coordination and education), and~        3. an in-home community health worker intervention (care coordination and education).~   "
76927|NCT02560077|"~     Cashew or Anacardium occidentale L. is a plant in a family of Anacardiaceae. The fruit of~     cashew or cashew apple may be consumed fresh, but contains high quantities of tannins~     yielding a bitter taste and dry mouth feel. Therefore, it is more often prepared as beverage.~     It is rich in carbohydrate and vitamin C. It is also claimed for numerous ailments including~     antitumor, antimicrobial, urease inhibitory and lipoxygenase activity. In addition, cashew~     apple juice also has excellent anti-oxidant potential. The preclinical data also demonstrated~     that cognitive deficit rats induced by cholinotoxin which received A.occidentale or cashew~     fruit juice for 2 weeks showed the neuroprotective and cognitive enhancing effects.Therefore,~     the potential benefit of Cashew apple juice on physical fitness and psychological fitness of~     the middle aged and elderly is focused.~   "
76928|NCT02560064|"~     Measurement of the small bowel length studied by anatomists, surgeons and radiologists.~     Results were highly different among these series. Technical and mechanical factors have major~     effects on measures. Investigators decided to reach a standardization for the measurement of~     small bowel length.~   "
78125|NCT02544425|"~     Open-labeled, multicenter phase II study of VIDL (VP-16, Ifosfamide, Dexamethasone,~     L-asparaginase) chemotherapy followed by high-dose chemotherapy and autologous stem cell~     transplantation in patients with stage III/IV extranodal NK/T-cell Lymphoma.~   "
76929|NCT02560051|"~     This study is for men who have prostate cancer and have failed local therapy or are not a~     candidate for prostatectomy or radiation therapy. The purpose of this research study is to~     assess the safety and benefit of androgen deprivation therapy (ADT, blocks hormones) plus~     chemotherapy. Degarelix is the hormone blocking drug that will be used. Doxorubicin,~     Ketoconazole, Docetaxel and Estramustine are the chemotherapy drugs that will be used. The~     drugs used in this study are approved by the Food and Drug Administration (FDA).~      Participants will be treated with ADT plus chemotherapy for three, four, or five 8-week~     cycles (12, 18, or 24 months). The number of cycles of chemotherapy they receive and the~     number of months they receive ADT will be based on their disease. The current standard~     treatment is ADT and chemotherapy. What differs in this research study is the cycling and~     combination of chemotherapy drugs chosen. The drugs chosen for this study have fewer side~     effects and are believed to provide maximum benefit.~   "
76930|NCT02560038|"~     This trial is for people with bladder cancer that has spread. The purpose of this research~     study is to see if the chemotherapy combination of gemcitabine and cisplatin plus paclitaxel~     is safe and effective treatment for bladder cancer.~      Paclitaxel, gemcitabine and cisplatin have all been approved by the United States Food and~     Drug Administration (FDA). Gemcitabine and cisplatin is a standard treatment for bladder~     cancer. There have been studies that show that paclitaxel and cisplatin have antitumor~     activity in bladder cancer. European researchers studied paclitaxel, gemcitabine and~     cisplatin (same drug combination in this trial) and found that the combination provided good~     disease control and was well tolerated. Investigators are studying the same drug combination,~     but at different dosages and schedule.~   "
76931|NCT02560025|"~     This research study is studying a targeted therapy (a form of treatment that uses drugs or~     other substances to identify and attack specific types of cancer cells with less harm to~     normal cells) as a possible treatment for high-risk acute myeloid leukemia.~      The names of the study interventions involved in this study are:~        -  Alisertib / MLN8237~        -  Cytarabine / Cytosine Arabinoside~        -  Idarubicin / Idarubicin hydrochloride~        -  Daunorubicin (Can be used in place of idarubicin)~   "
76932|NCT02560012|"~     This is for subjects with metastatic Renal Cell Cancer (RCC). There are four Food and Drug~     Administration (FDA) approved drugs for first-line therapy of Renal Cell Cancer (RCC) and two~     for second-line therapy. Each of these drugs targets a specific molecular pathway. At present~     oncologists select therapy based on current guidelines. There is a new method for trying to~     use biomarker information from the subject's tumor to select the best drug to treat the~     subject. This process is investigational, which is why this study is being done.~      Biomarkers are genes, proteins and other molecules that affect how cancer cells grow,~     multiply, die and respond to other compounds in the body. These biomarkers build a tumor~     profile or fingerprint of the subject's tumor. A new focus in cancer care is personalized~     treatment, where doctors select a drug based on the subject's tumor's unique fingerprint~     which is more likely to be effective in fighting the tumor. Selecting the treatment the~     subject is more likely to respond to requires a thorough understanding of the relationship~     between biomarker and treatment effect. The PI wants to gather data to understand that~     relationship to help treat future cancer patients. The purpose of this study is to evaluate~     efficacy of treatments that are selected based on tumor profiles.~   "
76933|NCT02559999|"~     Determine objective markers of pain perception remains a major scientific and medical issue.~     Various tools have been proposed to objectify pain, but their adaptability to different~     clinical contexts are limited. Our working hypothesis considers that the research for markers~     of immediate pain perception should be based on an electrophysiological approach, based on~     the combined analysis of EEG and autonomic responses.~   "
76934|NCT02559986|"~     Postpartum depression (PD) is a serious and disabling mental health condition that affects~     10-15% of women after childbirth. Low-income minority women are disproportionately affected.~     Untreated PD can lead to significant negative outcomes for both mother and child.~     Pediatricians are being asked to routinely screen for PD and while screening rates are~     improving, little is known about whether mothers actually adhere to pediatrician~     recommendations to seek additional help after a positive PD screen. The objective of this~     study is to describe the rate at which mothers seek treatment for suspected PD after a~     positive screen at the pediatrician office. Additional examination will look at factors that~     predict whether a mother recalls a recommendation to seek treatment.~   "
76935|NCT02559973|"~     This is a single-center, randomized, open-label, single-dose, parallel-group study which will~     enroll and randomize approximately 48 subjects (to achieve 36 completers) with opioid use~     disorder (OUD) who are seeking treatment for OUD. The study includes both a Residential~     (Inpatient) and Non-Residential (Outpatient) Period.~   "
76936|NCT02559960|"~     This registry aims to monitor the safety of Breviscapine Powder-Injection and to identify the~     potential risk factors for the adverse drug reactions.~   "
76937|NCT02559934|"~     The aim of this study is to assess the delivery of SR-T100 from the topical gel (containing~     2.3% solamargine in Solanum undatum plant extract) by determining the plasma levels of~     solamargine in subjects with AK while administration of a 25 cm2 contiguous or non-contiguous~     dermal treatment area.~   "
76938|NCT02559921|"~     This study evaluates the rabies virus neutralizing antibody (RVNA) activities ,safety and~     tolerability of rhRIG vs. HRIG in combination with rabies vaccine for human use (Vero cells)~     in healthy adult subjects.The study has 7 groups.Subjects will receive rhRIG（20 IU/kg）only,~     rhRIG（40 IU/kg）only,HRIG（20 IU/kg）only, rhRIG（20 IU/kg）in combination with rabies vaccine for~     human use, rhRIG（40 IU/kg）in combination with rabies vaccine for human use,HRIG（20 IU/kg）in~     combination with rabies vaccine for human use,and placebo in combination with rabies vaccine~     for human use,respectively.~   "
76939|NCT02559908|"~     This study will evaluate the safety and performance of VYC-25L hyaluronic acid injectable gel~     for the restoration and creation of facial volume in participants seeking to increase~     projection of the chin and/or jaw.~   "
76940|NCT02559895|"~     The purpose of this study is to assess ALD403 in the prevention of migraine headache in~     frequent episodic migraineurs.~   "
76941|NCT02559882|"~     The study aimed to assess the success of a clinically indicated renal denervation by~     different tests and correlate the results of the tests with the clinical outcome.~   "
76942|NCT02559869|"~     This is a multicenter, 18-month study, which aims to identify imaging and biofluid biomarkers~     in people with ALS to expand the understanding of ALS pathology, treatment targets, disease~     progression, and anatomical differences between different disease phenotypes. This pilot~     project is tailored to produce imaging tools that will allow researchers to conduct future~     ALS clinical trials more efficiently which may in turn impact the pace for ALS drug~     discovery.~   "
76943|NCT02559856|"~     This vanguard pilot study compares rivaroxaban and apixaban, two of the new oral blood~     thinners for the treatment of blood clots. Half of the patients will receive apixaban and~     half will receive rivaroxaban. The main objective is to determine the feasibility of patient~     recruitment and resources required to follow enrolled patients and inform for a larger,~     multi-centered trial and to assess which one is safer.~   "
76944|NCT02559843|"~     Introduction: Diabetes mellitus a chronic diseases, is the most common and important~     metabolic disease in human. Increased free radicals production due to hyperglycemia produces~     oxidative stress which worsens the disease and its complications. Pomegranate juice has~     antioxidant and antiatherosclerotic properties. The present study was planned to evaluate the~     effects of pomegranate juice consumption on glycemic control, lipid profile,blood pressure~     and oxidative stress in patients with type 2 diabetes~   "
76945|NCT02559830|"~     Evaluating the safety and efficacy of Lentiviral Hematopoietic Stem Cell Gene Therapy for~     advanced stage of Metachromatic Leukodystrophy and adrenoleukodystrophy.~   "
76946|NCT02559817|"~     The purpose of this study is to evaluate the safety and efficacy of linaclotide for the~     treatment of Irritable Bowel syndrome with Constipation (IBS-C), in children age 7-17 years.~      This study includes up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period.~     Patients age 7-11 will receive oral liquid or oral solid capsule and patients 12-17 will~     receive solid oral capsule formulation. Children ages 7-11 years meeting the entry criteria~     will be randomized to 1 of 3 doses of linaclotide or placebo for 4 weeks. Children ages 12-17~     years meeting the entry criteria will be randomized to 1 of 4 doses of linaclotide or placebo~     for 4 weeks.~      This 4-week study will assess the effects of linaclotide on bowel movement frequency, as well~     as other bowel symptoms of IBS-C.~   "
76947|NCT02559804|"~     To describe the natural history of peripheral neuroblastic tumour presenting with SCI and~     evaluate the combined effects of different risk factors on the eventual neurologic and~     orthopaedic outcomes~   "
76948|NCT02559791|"~     The steroid sparing effect of anti interleukin (IL-5) monoclonal antibody has been proven,~     but the effectiveness of subcutaneous (SC) compared to intravenous (IV) administration of~     these drugs to suppress airway eosinophilia is still under debate. As part of a previous~     study, 100mg of mepolizumab were administered subcutaneously to a group of subjects with~     prednisone-dependent eosinophilic asthma. Despite this intervention, 50% of the subjects (15~     patients participated in this study) had persistently elevated sputum eosinophil counts. The~     same 15 patients will be invited to participate in the current study, and if they provide~     their informed consent, will receive 2 monthly doses of placebo, followed by 4 monthly doses~     of IV reslizumab. The primary outcomes are blood and sputum eosinophils, and the secondary~     outcomes include sputum and blood Innate lymphoid cell-2 (ILC2) cells, cluster of~     differentiation 4 (CD4+) cells, cluster of differentiation-8 (CD8+) cells, cluster of~     differentiation-34 (CD34+), Eosinophil-Basophil cluster cells (Eo/B progenitor cells), forced~     expired volume in 1 second (FEV1), asthma control questionnaire (ACQ) and number of~     eosinophilic exacerbations. Measurements of the outcomes will be done before placebo, after~     placebo and after IV reslizumab. This study design will determine whether IV reslizumab is~     effective in suppressing airway eosinophilia in prednisone-dependent patients.~   "
76949|NCT02559778|"~     A prospective open label, multicenter study to evaluate the feasibility and acute toxicity of~     using molecularly guided therapy in combination with standard therapy followed by a~     Randomized Controlled Trial of standard immunotherapy with or without DFMO followed by DFMO~     maintenance for Subjects with Newly Diagnosed High-Risk Neuroblastoma.~   "
76950|NCT02559765|"~     This survey will investigate the views of people with progressive MS in terms of~     physiotherapy services. In particular the study will examine the proportion of people with~     progressive MS on the MS register who use physiotherapy services, how worthwhile they think~     it is for them and how they would like their physiotherapy to be delivered. This survey will~     also explore how physiotherapy services for people with progressive MS varies across the UK~     and what other types of rehabilitation services are currently used by people with progressive~     MS.~   "
76951|NCT02559752|"~     This study will explore neurocognitive performance in pediatric brain tumor patients~     receiving proton beam radiation therapy (PBRT). The investigators goal is to gather baseline~     neurocognitive testing prior to the completion of the first week of radiation therapy along~     with follow-up testing 6-12 months after the completion of radiation and serial annual~     testing thereafter. With these data the investigators plan to evaluate the effects of PBRT on~     neurocognitive performance as it relates to patients' age at diagnosis, tumor location, and~     radiation dose. Modeling studies have demonstrated that PBRT could improve neurocognitive~     outcomes, but there is a paucity of prospectively-collected patient data. The investigators~     are uniquely positioned to address this important question given the busy pediatric central~     nervous system (CNS) tumor service, the delivery of proton therapy at the S. Lee Kling Proton~     Therapy Center at Barnes-Jewish Hospital, and the multi-disciplinary research team with~     extensive experience into the late effects of therapy as it relates to neurocognition.~   "
77032|NCT02558699|"~     Radiofrequency catheter ablation is effective in the treatment of patients with paroxysmal~     atrial fibrillation. In order to reduce the recurrence rate after catheter ablation, we~     propose to apply 'virtual' ablation on patient-specific atria by simulating 3D atrial~     computer model. We will conduct virtual rotor mapping in the patient specific atrial model.~     Then, we will compare the clinical outcome of conventional circumferential pulmonary vein~     isolation and additional rotor ablation guided by virtual rotor mapping.~   "
77033|NCT02558686|"~     Application of trigger point dry needling can induce post-dry needling soreness. This is not~     a negative experience, but sometimes some patients want to reduce it as much as possible.~     Manual therapies and exercise strategies targeting to decrease post-dry needling soreness~     need to be investigated.~   "
78126|NCT02544412|"~     The purpose of this project is to study whether a mindfulness-based training program supports~     self-regulation, resiliency, effective classroom behaviors, and persistence in teaching.~   "
76952|NCT02559739|"~     Deficient sleep duration and sleep disturbances - such as insomnia, sleep disordered~     breathing (SDB) and restless legs syndrome (RLS)- are associated with hypertension and~     cardio-cerebrovascular morbidity and mortality. Several studies suggest that sleep disorders~     are frequent after stroke and detrimental for stroke outcome. However, more prospective~     studies in a large unselected sample of stroke survivors are needed to better investigate the~     short- and long-term consequences of sleep disturbances on mortality and occurrence of new~     cardio-cerebrovascular events. Also their pathophysiological mechanisms and their influence~     on stroke recovery should be better understood.~      Therefore, the aim of this study is to assess the impact of sleep deficiency and sleep~     fragmentation on the frequency of new cerebro- and cardiovascular events and death after~     stroke or transient ischemic attacks, and clinical outcome within one and two years after~     stroke.~      The working hypotheses are that stroke survivors with sleep deficiency and sleep~     fragmentation due to insomnia, sleep-disordered breathing or restless leg syndrome will~     present: (1) higher mortality from all causes and higher frequency of new cardio-/~     cerebrovascular events; and (2) a less favorable clinical outcome. Outcomes will be compared~     between patients with and without sleep deficiency and fragmentation.~      Since current clinical practice in cerebrovascular patients does not sufficiently consider~     sleep disorders in patient's management, this study can help to bring attention to a still~     overlooked medical problem and change the current standard of management of stroke survivors.~   "
76953|NCT02559726|"~     Hypertrophic cardiomyopathy (HCM) is a common genetic cardiovascular disease. Outflow-tract~     gradient of 30 mmHg or more under resting conditions is an independent determinant of~     symptoms of progressive heart failure and death.~      The investigators hypothesize that the electrical approach by dual chamber pacing could~     improve symptoms and reduce outflow-tract obstruction in a specific sub-group of selected~     patients with a mechanical hyper-synchronicity. The aim of the study is to identify and~     describe this phenomenon in HCM with (O-HCM) and without (NO-HCM) outflow-tract obstruction~     thanks to innovative multi-imaging approach.~   "
76954|NCT02559713|"~     The purpose of this study is to assess the concentration of vedolizumab in breast milk of~     lactating women with active ulcerative colitis (UC) or Crohn's disease (CD) who are receiving~     vedolizumab therapeutically.~   "
76955|NCT02559700|"~     This study is an open trial investigating the long-term use of an online brain training~     programme for adults over 50. It will determine whether there is sustained benefit to~     cognition, and whether this group can be engaged in this form of intervention over a period~     of 12 months.~   "
76956|NCT02559687|"~     In this study participants with advanced/metastatic adenocarcinoma or squamous cell carcinoma~     of the esophagus or advanced/metastatic Siewert type I adenocarcinoma of the esophagogastric~     junction (EGJ) previously treated with two standard therapies will be treated with~     pembrolizumab~   "
76957|NCT02559674|"~     This is a Phase Ib/II, open-label, multi-center, competitive enrollment and dose escalation~     study of ALT-803 in combination with gemcitabine and nab-paclitaxel in patients with advanced~     pancreatic cancer in conjunction with gemcitabine and nab-paclitaxel.~   "
76958|NCT02559661|"~     Operations in the retina and removal of the vitreous (vitrectomy) is a type of operation~     where the surgeon requires much training and where there is an increased risk of operative~     complications in the early stage. For this reason, virtual surgery is suited to help training~     and subsequent maintenance of operational skills [1, 2].~      There are no previously published research in virtual vitreoretinal surgery, but this is~     nevertheless vital to better surgical training.~      Many surgical disorders - such as retinal detachment - progresses with time, and it is often~     not known when to ideally operate [3]. On one hand, it may be best to operate early and~     thereby reduce the risk of disease progression before surgery. On the other hand, it is also~     important to take into account factors such as the presence of the correct operational~     expertise as well as the surgeon's fatigue and stress levels. These mentioned matters is~     difficult to test clinically. With virtual surgery it will be possible to introduce various~     operational distractions and see what impact it has on operating performance.~      The purpose of the study 'Virtual vitreoretinal surgery: construction of a training program~     and analysis of significant factors for operating performance' is 1) to facilitate the~     training of future vitreoretinal surgeons by introducing a virtual training program with high~     construction validity, and 2) to clarify which external conditions affects the performance of~     trained operator using the virtual training program.~   "
76959|NCT02559648|"~     This is a single-site, randomized, placebo-controlled, double blind phase 2b clinical trial.~     Patients with Thalassemia will participate in this study and will be treated with Denosumab~     or placebo. The effect of Denosumab on lumbar spine BMD in patients with Thalassemia Major~     and Osteoporosis will be evaluated as compared with control (placebo) at 12 months.~   "
76960|NCT02559635|"~     Postoperative ileus is the most commonly observed morbidity following ileostomy closure.~     Studies have previously demonstrated that the defunctionalized bowel of a loop ileostomy~     undergoes a series of functional and structural changes. It has been hypothesized that these~     changes may contribute to the development of postoperative ileus, and that stimulating the~     distal limb of a loop ileostomy prior to closure may functionally prepare the excluded bowel~     for intestinal transit.~      The purpose of the multicenter, randomized controlled trial is to determine the impact of~     preoperative stimulation of the distal limb of a loop ileostomy on postoperative ileus.~   "
76961|NCT02559622|"~     The purpose of this study was to explore the effect of treatment with 300 mg or with 150 mg~     secukinumab (administered weekly for 4 weeks followed by four-weekly administration) on~     endothelial dysfunction and arterial stiffness after 12 weeks and for up to 52 weeks in~     subjects with chronic plaque-type psoriasis. Furthermore soluble biomarkers were assessed to~     evaluate the influence of secukinumab on cardiovascular risk. Magnetic resonance imaging~     (MRI) was performed in a sub-population to assess the treatment effect on arterial vessel~     wall morphometry in atherosclerosis prone vascular beds.~   "
77034|NCT02558673|"~     The purpose of this study was to understand the production of trimethylamine-N-oxide (TMAO)~     and its metabolites from dietary precursors found in fish, eggs and beef. In addition, this~     study traced the fate of supplemental TMAO that has been labeled with deuterium to determine~     how TMAO is being used in the body.~   "
88401|NCT02410018|"~     This is a prospective, pilot, open-label, uncontrolled, safety and effectiveness study of~     uterine artery embolization with OCL 503 in women with leiomyomata who are scheduled for~     hysterectomy.~   "
76962|NCT02559609|"~     Despite recent improvements in the US economy, unemployment remains a significant concern,~     and estimates indicate that one-third of unemployed persons drink at hazardous levels,~     adversely impacting their health and abilities to find jobs. Reinforcement interventions are~     highly efficacious in reducing substance use, and they can be applied to increase job-seeking~     activities as well. In partnership with CT United Labor Agency, this project is designed to~     reduce hazardous drinking and enhance active participation in job-seeking activities among~     those with job loss. It will evaluate the independent and combined effects of reinforcing~     negative breathalyzer samples and job-seeking activities to ascertain the simplest and most~     cost-effective approach to improving outcomes in this population. Unemployed individuals with~     hazardous drinking (N = 280) will be randomly assigned to one of four conditions using a 2 x~     2 design: standard care, standard care with reinforcement for submitting negative~     breathalyzer samples, standard care with reinforcement for job-seeking activities, or~     standard care plus reinforcement for both negative breathalyzer samples and job-seeking~     activities. Participants in all conditions will receive usual services part of CT United~     Labor Agency, along with a novel remote breath alcohol monitoring procedure. The study~     interventions will be in effect for three months, and participants will be followed for one~     year. Alcohol and other drug use, employment, psychiatric symptoms, and global measures of~     health will be assessed throughout treatment and follow-up. Reinforcing negative breathalyzer~     samples is expected to significantly reduce drinking, and reinforcing job-seeking activities~     is expected to increase re-employment rates and reduce time until job attainment. Reinforcing~     both negative breathalyzer samples and job-seeking activities is hypothesized to improve~     outcomes along both domains. The reinforcement interventions may also decrease psychiatric~     distress and slow progression of physical decline, common among the unemployed. If~     efficacious and cost-effective, results from this study may stimulate adoption of~     reinforcement interventions in the context of unemployment services. Reducing the adverse~     consequences of hazardous drinking and improving job re-entry may have pronounced benefits in~     a highly vulnerable segment of the US population.~   "
76963|NCT02559596|"~     The purpose of this study is to investigate whether there is an association between stroke or~     heart attack and reactivation of varicella zoster virus, measured by antibody levels, using~     linked data from the Health Survey for England and secondary care.~   "
76964|NCT02559583|"~     The primary purpose of the study is to quantify participants' demographic parameters, country~     standard therapies, treatment patterns and outcomes among participants with chronic~     lymphocytic leukemia (CLL), multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) in~     oncology concentration hospitals in Latin America.~   "
76965|NCT02559570|"~     The purpose of this study is to evaluate the safety and efficacy of linaclotide for the~     treatment of functional constipation (FC), in children age 6-17 years. This study includes up~     to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period. Patients age 6-11 will~     receive oral liquid formulation and patients 12-17 will receive solid oral capsule or liquid~     oral solution.~      Children ages 6-11 years meeting the entry criteria will be randomized to 1 of 3 doses of~     linaclotide or placebo for 4 weeks. Children ages 12-17 years meeting the entry criteria will~     be randomized to 1 of 4 doses of linaclotide or placebo for 4 weeks.~      This 4-week study will assess the effects of linaclotide on bowel movement frequency, as well~     as other bowel symptoms of FC.~   "
76966|NCT02559557|"~     This pilot clinical trial studies a culturally adapted skills training and educational~     intervention in guiding parents of younger acute lymphoblastic leukemia (ALL) or acute~     myeloid leukemia (AML) survivors at risk for long-term attention and memory problems (late~     neurocognitive effects). ALL and AML treatments target the central nervous system and may put~     younger survivors at increased risk for late neurocognitive effects, which may lead to~     learning difficulties or behavior problems and poor health-related quality of life.~     Spanish-speaking parents of young ALL or AML survivors may not have access to the~     information, resources, or guidance to help their children through these difficulties.~     Adapting an existing parent-training program into Spanish may help teach Spanish-speaking~     parents effective ways to prevent or reduce learning and behavioral difficulties, which may~     improve the quality of life of parents and young ALL or AML survivors.~   "
76967|NCT02559544|"~     Evaluate [18F]FES PET/CT uptake as a predictor of progression free survival in endocrine~     refractory recurrent or metastatic breast cancer patients starting a new therapy regimen~     including endocrine targeted therapy.~   "
76968|NCT02559531|"~     The Swiss Emergency Triage Scale (SETS) in used for triage in emergency departments in~     Switzerland, France and Belgium. No validated triage scale is actually used by Emergency~     Medical Service (EMS) providers. The objective of this project is to evaluate the reliability~     and performance of triage by EMS providers with the SETS.~   "
76969|NCT02559518|"~     A crossover trial with healthy volunteers will be conducted. Six sessions will be performed~     once a week in a counterbalanced order and at least with seven days washout period to~     minimize carry-over effects. In each session, volunteers will be submitted to: fatigue and~     attention levels evaluation, cortical brain activity measures through paired pulse~     transcranial magnetic stimulation (pp-TMS), handwriting test, non-invasive cerebellar~     stimulation during serial reaction time task (SRTT) and performance perception evaluation.~   "
76970|NCT02559505|"~     This study evaluates how different methods of early exposure to influenza (natural infection,~     live attenuated influenza vaccination, inactivated influenza vaccination) initially stimulate~     immunity and poise the immune system to respond to a future challenge with the inactivated~     influenza vaccine.~   "
76971|NCT02559492|"~     This is an open-label, Phase 1b, platform study in subjects with advanced or metastatic solid~     tumors. The study will be divided into 3 parts (Part 1a, Part 1b, and Part 2). Part 1a will~     evaluate a JAK inhibitor with JAK1 selectivity (Itacitinib) in combination with an IDO1~     inhibitor (epacadostat; INCB024360; Group A) and Itacitinib in combination with a PI3K-delta~     inhibitor (INCB050465; Group B) to determine the MTD or PAD and the recommended Part 1b doses~     for each combination. Once the recommended dose has been identified for each treatment group~     in Part 1a, subjects with advanced solid tumors will be enrolled into expansion cohorts based~     upon prior treatment history with a PD-1 pathway-targeted agent (Part 1b). In Part 2,~     additional expansion cohorts will be enrolled to further evaluate lower doses of itacitinib~     and INCB050465 in subjects with select tumor types.~   "
77035|NCT02558660|"~     The purpose of this study is to evaluate the impact of a brief clinic-based educational~     intervention on utilization of Double Up Food Bucks (DUFB)—a Michigan-wide Supplemental~     Nutrition Assistance Program (SNAP) healthy food incentive--among low income health center~     patients at a community health center in Southeast Michigan.~   "
77084|NCT02558023|"~     The objective of this study is to demonstrate that urapidil is not inferior to nicardipine~     for the treatment of hypertension associated with preeclampsia (PE) and that it is better~     tolerated.~        -  efficacy endpoint : mean arterial blood pressure corrected to 100-120 mmHg after 120 min~          of study drug administration.~        -  safety endpoints : clinical and biological observation for any side effect. All infants~          will be observed in the neonatology unit (during 48h).~      Pharmacokinetic study included to study :~        -  transplacental transfer,~        -  transfer in breast milk,~        -  and neonatal elimination (premature babies of mothers treated with urapidil (less than~          33 WG))~   "
76972|NCT02559479|"~     The objective of the study is to assess the effect of low-calorie diets with normal (18%) vs.~     high (35%) protein (mainly coming from animal source) composition on body weight and~     carbohydrates metabolism in overweight and obese subjects with pre-diabetes or diabetes. A~     dietary intervention is carried out during 6 months in 100 subjects who are individually~     randomized to an energy-restricted diet with two types of macronutrients composition: 1) 35%~     protein, 30% fat and 35% carbohydrates and 2) 18% protein, 30% fat and 52% carbohydrates.~     Around 80% of total protein in diet comes from animal source (of whom around 40% from lean~     red meat). Subjects are provided with weekly menus and different recipes to use them as part~     of the diet. Monitoring visits with the nutritionist will be performed every 15 days. At the~     beginning of the study, after 3 and 6 months, the following parameters are determined:~     anthropometric (weight, waist circumference, body mass index and body composition), blood~     pressure, dietary (72-hours dietary registry) and exercise and biochemical analysis (total~     cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, apolipoproteins A1 and B, iron,~     transferring, ferritin, uric acid, glucose, HbA1c, insulin, adiponectin and resistin). Urine~     samples are also collected to assess microalbuminuria and ureic nitrogen.~   "
76973|NCT02559466|"~     Repetitive transcranial magnetic stimulation (TMS) is an emergent non-invasive treatment for~     treatment resistant depression (TRD). The exact neuro-functional mechanisms related to TMS~     efficiency remains however unknown; besides local effect on the target, TMS may induce~     interaction changes between remote cerebral regions. On the other hand, few studies have been~     performed in comparison to sham placebo stimulation. The investigators recently showed that~     non-responder depressive patients to TMS exhibited deeper and wider brain functional~     abnormalities hardly reachable by standard coils. The H1-Coil is a novel TMS (H-TMS) device~     capable of inducing a magnetic field with a deeper and wider distribution than standard~     coils.~      The investigators design here a randomized controlled study in which the investigators will~     compare the clinical effects of H-coil TMS and standard TMS in patients with TRD, and their~     functional neuroanatomical correlates and changes in connectivity by Positron Emission~     Tomography (PET). The general objective is to better understand the mechanisms related to TMS~     efficiency in pharmacoresistant depression, in order to propose the best therapeutic approach~     for the patient.~   "
76974|NCT02559453|"~     We have designed this study to determine whether performing two, compared with ≥3 operations~     has an effect on key clinical outcomes after discharge from the hospital of an infected wound~     that requires admission. Each arm of this study represents the two commonly practiced~     standard of care treatment plans for patients presenting with infected wounds. It is~     currently unknown which SoC option provides the best patient outcome.~   "
76975|NCT02559440|"~     The purpose of this study is to determine the effect of MF/OXY in the treatment of adenoid~     hypertrophy children with severe allergic rhinitis.~   "
76976|NCT02559427|"~     The purpose of this study is to determine whether 3-week of SPA therapy improves sleep apnea~     in patients with chronic venous insufficiency and concomitant Obstructive Sleep Apnea~     Syndrome (OSAS).~   "
76977|NCT02559414|"~     The proposed study will add to the growing understanding of platelet activity and platelet~     inhibition in subjects with HIV. It will examine the relationship between platelet activity~     and its inhibition by antiplatelet therapy (aspirin monotherapy and clopidogrel monotherapy)~     in this high-risk cohort. Furthermore, it will provide important data on the mechanism of~     platelet activity and its inhibition using biomarkers of platelet activity, inflammation,~     immune activity and endothelial function and genetic expression profiling.~   "
76978|NCT02559401|"~     Currently, standard-of-care tractography is based on information obtained from diffusion~     tensor imaging (DTI). DTI is a diffusion magnetic resonance imaging (dMRI) technique that is~     routinely obtained on neurosurgical patients to assist in pre-operative planning. The primary~     objective of the proposed study is to determine the ability of msHARDI-based tractography to~     discern fibers in edematous brain regions.~   "
76979|NCT02559388|"~     In this study hemodialysis patients that underwent dialysis thrice weekly screen for uremic~     pruritus and 80 patients that at least have refractive pruritus that lead to sleep and daily~     activity disorders enroll in this study. These patients should have at least a course of~     therapy without proper response. After proper informing patients and taking testimonial~     patients enter to study. Then patients randomized in case and control group. In case group,~     patients took montelukast 10 milligram daily and in control group took placebo for 30 days.~     Other antipruritic or antiinflammatory medication has been stopped one week prior to starting~     treatment. Calcium, phosphorous, urea, creatinine, highly sensitive CRP (hsCRP), Parathyroid~     Hormone (PTH), hemoglobin and kt/V were measured at beginning and at end of study. pruritus~     severity assessed by Detailed Pruritus Score that introduced by Duo and Visual Analogue Score~     in beginning and at end of study in both group. Sleep disorder score and its severity added~     to crude score at beginning and end of study and change of measures analyzed.~   "
76980|NCT02559375|"~     This study will increase knowledge of patient preferences for pain treatments, and improve~     the ability to meet patients pain management needs. This study will assess patient attitudes~     towards underutilized treatments and identify technologies to increase awareness of such~     treatments. This study also demonstrate the feasibility of using the Penn Cancer Network in~     future clinical and cancer control research and better understand how to effectively raise~     patients awareness of supportive cancer services.~   "
76981|NCT02559362|"~     The goal of the study is to establish the feasibility/willingness of breast cancer patients~     to delay surgery to do an exercise program, or be randomized to an exercise training program~     following treatment, and to see if that willingness correlates with prior physical activity~     history.~   "
76982|NCT02559349|"~     A pilot, single arm, single center study to determine the feasibility of obtaining stool~     samples from adult patients receiving SBRT to a lung tumor, if SBRT induces changes in the~     gut microbiota and to obtain preliminary data about possible correlation of baseline~     composition and changes in gut microbiota with tumor response, local control, and development~     of pneumonitis/other side effects.~   "
77157|NCT02557074|"~     In a prospective pilot study the investigators showed that low doses of IL2 could be~     beneficial for severe AA inducing a long lasting regrowth in 4 out of the 5 patients treated.~      The objective of this study is to compare the long term efficacy of low doses of IL2 versus~     placebo in a multicenter prospective randomized double blind study.~   "
76983|NCT02559336|"~     Advanced cancer patients have a poor quality of life and a high rate of unplanned hospital~     admissions. Palliative care has been shown to improve patient outcomes such as quality of~     life and symptom burden. Our long-term aim is to study the effect of Supportive and~     Palliative Care Review Kit (SPaRK) - a novel model of early palliative care in the acute~     hospital inpatient setting. To this end, we propose a pilot study that will provide the~     necessary information for the planning of a subsequent larger scale Phase III trial of SPaRK.~      The specific aims of this pilot study are: 1) to estimate the recruitment rate and ability of~     advanced cancer patients to complete the Functional Assessment of Cancer Therapy - General~     (FACT-G) questionnaire, which measures health-related quality of life (QOL) in the four~     domains of physical well-being, social/family well-being, emotional well-being, and~     functional well-being, 2) to obtain a tentative estimate of the effect size of the SPaRK~     model of care on change in patient QOL over 6 days, 3) to explore the responsiveness to~     change of FACT-G over 3 days and 4) to explore views of healthcare professionals and~     stakeholders on SPaRK as a model of integrated palliative care and oncology care service~     delivery.~      In the short term, the results from this study will be used to plan a larger scale Phase III~     study of SPaRK. In the long term, a resource-efficient and effective model of care needs to~     be developed for the aging population and rising palliative care needs of patients. If~     successful, this pilot study will lead on to the testing of SPaRK, which does not rely wholly~     on specialist palliative care manpower, but involves both specialists and non-specialists~     working together to provide palliative care, and hence can be feasibly scaled up across~     institutions and extended to non-cancer patients.~   "
76984|NCT02559323|"~     Cancer survivors face unique health challenges as a result of their cancer diagnosis and~     treatment. OncoLink created an Internet based program for survivors to learn about their~     risks. A follow up survey will allow us to continue to develop the program in ways that will~     benefit users. This survey will need to be conducted via email, which will require the~     collection of the users email address and a secure method of linking the users care plan~     questionnaire answers to their survey answers.~   "
76985|NCT02559310|"~     This study evaluates the safety and efficacy of lefamulin, a pleuromutilin, for the treatment~     of adults with moderate to severe community-acquired bacterial pneumonia.~   "
76986|NCT02559297|"~     This prospective interventional study aims to compare sevoflurane and desflurane anesthetic~     agents on regulatory T cell (Treg) numbers and its cytokine production in patients undergoing~     Living Donor Kidney Transplant (LDKT).~   "
76987|NCT02559284|"~     The main objective of this study is to compare the effects of RESPIMER® NetiFlow® solution~     and device versus saline solution (0.9% NaCl), the standard treatment, used with RESPIMER®~     NetiFlow® device, both used postoperative care, in the context of ethmoid sinus surgery, at~     14 days post-surgery.~   "
76988|NCT02559271|"~     The study is used to verify the accuracy and repeatability of Smart Vision Labs Refractor in~     a pediatric population (between 5 and 16 years of age).~   "
76989|NCT02559258|"~     This is a single-center, randomized, double-blind, placebo-controlled, single-dose, dose-~     escalation study in otherwise healthy cat-, dust mite-, or Bermuda grass-allergic male and~     female subjects. There will be five dosing cohorts (0.1, 0.3, 1.0, 3.0 and 10.0 mg/kg), with~     eight subjects in each cohort, randomized to either epsi-gam (6 subjects) or placebo (2~     subjects) for a total of 40 subjects. The first cohort will receive the starting dose of 0.1~     mg/kg epsi-gam or placebo and subsequent cohorts will be recruited sequentially to receive~     escalating doses of epsi-gam or placebo.~   "
76990|NCT02559245|"~     This study evaluates effect of Ficus carica and Descurainia Sophia on irritable bowel~     syndrome predominant constipation. one-third of patients will receive Ficus carica, another~     one-third will receive Descurainia Sophia and remained patients only will follow their~     regular diet for 4 months.~   "
76991|NCT02559232|"~     This is a retrospective observational study to describe the sociodemographic and clinical~     characteristics of patients diagnosed with non-valvular atrial fibrillation (NVAF) at risk of~     stroke or systemic embolism, who at least three months ago changed their anticoagulant~     therapy, due to any clinical situation, and are currently on treatment with a direct oral~     anticoagulant (DOAC)~   "
76992|NCT02559219|"~     Smart Adult Living After Childhood Cancer (SmartALACC) Online Care Plans: Feasibility and~     Patient Satisfaction is a pilot project designed to test the feasibility and acceptability of~     use of an online care plan generator for adult survivors of pediatric cancers.~      Because of improvements in cancer screening, diagnosis and treatment, there are an estimated~     13 million cancer survivors living in the U.S. today, with projected growth to 18 million by~     2020 (De Moor). These survivors include survivors of leukemia and lymphoma, as well as solid~     tumors including breast, colon, testicular and prostate cancers. It also include a subset of~     patients who are survivors of pediatric cancers, as over 80% of children diagnosed with~     cancer today are cured. In fact, it is estimated that 1 in every 600 young adults between the~     ages of 20-35 is a cancer survivor (Dreyer, Hewitt, Greenlee).~      Cancer patients as a whole, despite improved cure rates, have been shown to receive~     inadequate medical care as survivors. Comprehensive survivorship care should include routine~     age appropriate medical care as well as information about prior diagnosis and treatment, and~     screening for recurrence of their primary malignancy as well as secondary malignancies, and~     screening for late effects of cancer treatment (Earle, Craig). Adult survivors of pediatric~     cancer, exposed to life-saving but toxic treatments during times of growth and development,~     are particularly prone to late effects but also have been shown to have inadequate monitoring~     and follow up. This is a concern as late effects of treatment are sometimes silent for years~     or decades after completion of cancer therapy and that adult survivors of childhood cancer,~     years from their diagnosis and treatment, have been shown to have alarming rates of life~     threatening chronic health conditions compared to their peers (Oeffinger). Thus, these late~     effects may emerge during adulthood when patients have moved on from the care of their~     primary oncologist. Complicating matters, primary care providers, who often assume the care~     of these patients, may not have the knowledge or tools necessary to appropriately care for~     survivors of childhood cancer (Suh).~      National organizations have come together to identify ways to improve quality of and access~     to long term follow up care for adult survivors of childhood cancer. The Children's Oncology~     Group published Long Term Follow up guidelines which recommend lifelong risk based follow up~     care and screening (COG guidelines). In addition, in 2005, the Institute of Medicine~     published a report, From Cancer Patient to Cancer Survivor: Lost in Transition gave~     recommendations to improve health outcomes of cancer survivors which includes the receipt of~     a comprehensive care summary and follow up plan to aid in appropriate risk based follow up~     care (Hewitt). Despite these recommendations childhood cancer survivors knowledge about past~     diagnosis and treatment and engagement in follow up care is suboptimal (Kaden-Lottick,~     Nathan). It has been demonstrated that pediatric cancer survivors are not receiving care~     summaries, and thus may try to find appropriate follow up information via the other sources~     such as the internet (Casillas).~      Oncolife, a free online tool to create survivorship care plans, was created in May 2007 (Hill~     2009), and has been housed at maintained at the University of Pennsylvania since then. This~     tool has shown to be feasible way to provide information and care plans to survivors of adult~     cancers. In addition, survivors who have used the resource, state that it will, or has~     already, positively influenced communication about cancer related follow up with their~     healthcare team (Hill 2013).~      The study aim is to adapt Oncolife to provide individualized information for adult survivors~     of childhood cancer with the unique recommendations for long term follow up for pediatric~     cancer survivors. Oncolife has already been collecting data on plans created by adult~     survivors of adult cancers and has been reviewed by the IRB previously (IRB#806368 and~     #811528 note: previously called Oncolink). Adaption of Oncolife to meet the needs of adult~     survivors of childhood cancer will improve access to high quality electronic health~     information as patients may find long term follow up guidelines cumbersome or largely~     irrelevant to their needs depending on their specific exposures. Individualizing the~     available information to a particular survivor will allow for better understanding of and~     improved adherence to recommended cancer related follow up care. We propose to develop~     survivorship care plans in a way that will most benefit users, thus after creation of the~     Smart Adult Living After Childhood Cancer care plan we will ask for patient input via survey~     immediately after receipt of their care plan and in a one month follow up survey.~   "
76993|NCT02559206|"~     The objectives of this study are to evaluate the safety, efficacy, and dose response of two~     delayed release formulations of linaclotide (DR; DR formulation 1 is DR1; DR formulation 2 is~     DR2) administered orally to patients with irritable bowel syndrome with constipation (IBS-C).~     Additional objectives include understanding how the two DR formulations compare with each~     other and with the FDA-approved 290 μg LINZESS® (the immediate release [IR] formulation of~     linaclotide).~   "
76994|NCT02559193|"~     The Study is a single-arm prospective trial of patients receiving at least one medication~     with a known association between genetics and drug metabolism. All patients will undergo~     genetic testing as determined by their treating physician. The specific genes tested will, in~     general, be based upon the drugs the patients are taking or those that the patient's treating~     physician is considering as potential substitutes for current medications.~   "
76995|NCT02559180|"~     Treatment of diabetic macular edema with intravitreal aflibercept in subjects previously~     treated with intravitreal anti-Vegf agents (ranibizumab or bevacizumab)~   "
77028|NCT02558751|"~     The investigators hypothesized that vaccination with either the 23-valent pneumococcal~     polysaccharide vaccine (PPV23) alone or the 13-valent pneumococcal conjugate vaccine (PCV 13)~     followed by PPV23 results in similar antibody levels/functional activity and induce a similar~     pneumococcal polysaccharide (PPS)-specific B cell response in HIV-positive individuals >50~     years of age and HIV-negative persons>50 years of age. The investigators immunized the study~     group HIV+ persons>50 and controls (HIV negative >50 years) with PCV13 followed by PPV23 and~     HIV+>50 with PPV23 alone. The investigators examined immune responses to PPS23F and PPS14 on~     a quantitative and qualitative level using ELISA and opsonophagocytic assays (OPA).~      To test the hypothesis that the levels of antigen specific B cells identified with PPS were~     comparable between the PPV23 and PCV13 vaccine recipients. Pre- and post-immunization~     peripheral blood samples were obtained. Extensive B cell phenotype analysis using fluorescent~     antibodies was used to characterize PPS-labeled B cells. Specific phenotypes were correlated~     with antibody levels and OPA and compared to historic populations immunized with PPV.~   "
76996|NCT02559167|"~     In this study, the investigators seek to evaluate the effects of cannabidiol (CBD) on cocaine~     craving and relapse. Cocaine addiction is characterized by compulsive substance use and~     repetitive urges to consume the drug even after a sustained period of abstinence. While~     substance use remains the most obvious direct outcome of addiction, there is a growing~     interest in other core symptoms of this disorder. Craving has become a subject of great~     interest as it is a reliable intermediate phenotype of cocaine relapse and a distressing~     symptom of addiction associated with suffering. Indeed, even after a period of abstinence,~     cocaine-dependent individuals remain vulnerable to stress and other craving-inducing stimuli,~     which, in turn, lead to intense physiological responses and various negative feelings such as~     anger and sadness. Real-time daily monitoring of craving and drug use has shown that craving~     predicts cocaine relapse among cocaine-dependent individuals. In sum, working toward~     improving the treatment of craving could not only help prevent relapse, but also reduce~     patient distress on emotional, cognitive, and physiological levels. In the past decades,~     significant scientific efforts have been deployed toward the development of innovative~     strategies to beat cocaine addiction, but with partial success thus far. Psychosocial~     approaches have been widely used to help cocaine-dependent patients achieve better outcomes~     after drug cessation, but literature indicates that these strategies alone are at times~     insufficient to induce significant behavioural changes or a reduction in rates of drug~     consumption. Unlike other types of addiction, such as opioid and alcohol, no pharmacological~     treatment has yet been found to be truly effective in relieving cocaine-cessation symptoms~     like craving and anxiety or to prevent relapse. CBD is a natural cannabinoid with a~     favourable tolerability profile and discrete neurobiological actions that are linked to~     neural circuits closely involved in addiction disorders. Addiction to cocaine is~     characterized by alternating phases of intoxication and short abstinence, followed by~     recurrent drug-craving episodes which result in distress and relapse. Our hypothesis is that~     CBD a cannabinoid known for its broad spectrum properties is an interesting pharmacological~     contender to decrease cocaine craving and treat cocaine addiction. Previous studies conducted~     in animals and humans confirm that CBD is a very safe and tolerable medication.~   "
76997|NCT02559154|"~     To investigate the efficacy of a modified bortezomib based combination therapy for patients~     with multiple myeloma.~   "
76998|NCT02559141|"~     The Nexfin monitoring system offers a complete non-invasive approach to a continuously~     estimation of blood pressure, CI and PPV by means of finger-cuff based pulse contour~     analysis. Several clinical investigations have proven reliability and interchangeability of~     the Nexfin technology yielding acceptable results especially regarding the trending~     abilities. At present there is no evidence available, whether a early goal directed~     hemodynamic optimization protocol based on a completely non-invasive monitoring technology is~     able to reduce postoperative complication. Therefore, the aim of this single-center study is~     to compare the clinical outcome and postoperative complications of patients undergoing major~     colorectal surgery treated with standard of care or with a GDT protocol based on the Nexfin~     technology.~   "
76999|NCT02559128|"~     The purpose of this cross-sectional comparative 2x2 trial study is to compare the degree of~     insulin resistance, myocardial function and selected metabolic parameters and to explore the~     pathophysiological mechanisms by which insulin resistance is implicated in development of~     chronic heart failure (HF) in patients with type 2 diabetes and prediabetes (T2D).~      Investigators hypothesize that patients with heart failure will be insulin-resistant and will~     display metabolic abnormalities as patients with diabetes.~   "
77000|NCT02559115|"~     The purpose of this study is to see if a new diagnostic research agent named 68Ga-RM2 can~     show prostate cancer on a PET/CT scan. 68Ga-RM2 stands for Galium-68 labeled~     DOTA-4-amino-1-carboxymethylpiperidine-D-Phe-Gln-Trp-Ala-Val-Gly-His-Sta-Leu-NH2. This study~     is being done because there are unmet medical needs to improve the current ways of detecting~     prostate cancers before surgery.~   "
77001|NCT02559102|"~     This is a prospective randomized controlled trial comparing dexmedetomidine sedation with~     caudal anaesthesia, and general sevoflurane anaesthesia with caudal anaesthesia for inguinal~     herniotomies in neonates and infants below 3 months of age.~      The investigators will compare the efficacy and adverse events associated with each of these~     techniques and neurodevelopmental outcomes of the infants in each group at 6 months and 2~     years of age.~   "
77002|NCT02559089|"~     Anti-NMDA receptor encephalitis is the most common curable non-infectious autoimmune~     encephalitis，but because of the lack of recognition in the clinic, usually been misdiagnosed~     as other causes of encephalitis. Therefore, it is urgent to establish a database of anti-NMDA~     receptor encephalitis in Chinese population. The multi-center, prospective clinical trial of~     anti-NMDA receptor encephalitis in China's , combined with Beijing Xuanwu hospital, Beijing~     Tiantan Hospital, Beijing Children's Hospital and other hospitals around the country, by~     screening the NMDA receptor antibody and summarizing the cases analysis, in order to provide~     evidence for clinical diagnosis and treatment of anti-NMDA receptor encephalitis.~   "
77003|NCT02559076|"~     The aim of the present study was to investigate the potential factors that determine~     preschool obesity in Al Ain, United Arab Emirates, and assess the effectiveness of a simple~     healthy lifestyle tool: Eat Right Emirates (ERE) adapted from the Ten Steps for Healthy~     Toddlers, produced in the UK by the Infant and Toddler Forum.~   "
77004|NCT02559063|"~     This project seeks to identify neural changes that occur in adults with mild cognitive~     impairment (MCI) after engagement in computerized cognitive training. In addition, this~     project aims to identify physiological factors that may bolster effects of the training on~     cognitive function. Individuals with MCI are at high risk for Alzheimer's disease (AD).~     Understanding how cognitive training protects cognitive function in MCI can contribute to~     development of effective interventions to slow progression to AD in individuals at risk,~     thereby reducing the significant morbidity and health care costs associated with AD.~   "
77005|NCT02559050|"~     A 7-year-old arhinia patient receives nasal reconstruction with nasal cavity reconstruction~     and is aided with the application of a 3D-printed nasal stent to prevent nasal cavity~     constriction.~   "
77006|NCT02559037|"~     The purpose of this study is to observe the efficacy and safety of acupuncture and~     moxibustion for Crohn's disease and the regulation mechanism of intestinal microbiota and~     mucosal immunity.~   "
77007|NCT02559024|"~     This study will test the ability of an immune modulator, anti-OX40 (MEDI6469) to alter the~     immune cell environment within colorectal cancer metastases. The drug will be administered to~     patients before surgical treatment.~   "
77029|NCT02558738|"~     In this observational study, insights regarding the tolerability and influence on the quality~     of life of the topical treatment with Ectoin Ear Spray compared to Normison ear spray shall~     be gained under real life conditions in patients with chronic eczematous irritations and~     pruritus of the outer ear canal.~   "
77211|NCT02556372|"~     This is a Phase 2, pilot study in which JKB-122 is given once daily for 24 weeks in subjects~     with autoimmune hepatitis (AIH) who have liver enzymes that are 1.25 to 10 times the upper~     limit of normal (ULN) and who have had a failed response to, incomplete response to,~     intolerant to, ineligible to, or unwilling to take current immunosuppressant therapies. The~     dose of JKB-122 will be escalated monthly.~   "
77008|NCT02559011|"~     Transcatheter aortic valve implantation (TAVI) has emerged as a valuable minimal-invasive~     treatment option in patients with symptomatic severe aortic valve (AV) stenosis at~     prohibitive or increased risk for conventional open-heart surgery. Recent randomized clinical~     trials reported a large treatment effect of TAVI over medical treatment among inoperable~     patients and similar or superior outcomes compared with surgical aortic valve replacement in~     high to intermediate risk patients. However, atrio-ventricular conduction disturbances and~     arrhythmias (in particular atrial fibrillation) before, during or after TAVI remain a matter~     of concern as they have important consequences.~      The objective of this study is to investigate the incidence, nature and prognostic~     significance of AV-conduction disturbances and arrhythmias among patients with severe,~     symptomatic aortic stenosis undergoing TAVI before, during and after the procedure using a~     small implantable cardiac monitoring system (ICM; Medtronic REVEAL LinQTM).~      One hundred patients will be enrolled in this study. Prior to TAVI (at least 4 weeks), at the~     time of preprocedural hemodynamic and anatomical assessment, the ICM will be inserted under~     the skin of the chest under local anesthesia. The device will be interrogated just prior to~     readmission for TAVI and thereafter at 1, 3, 6, and 12 months of follow-up. The incidence of~     symptomatic as well as silent brady- and tachyarrhythmias will be recorded, and its impact on~     medical and device treatment as well as clinical outcomes analyzed.~      The present study will provide information about the actual incidence and impact of~     symptomatic and silent arrhythmias and AV-conduction disturbances among patients with severe,~     symptomatic aortic stenosis undergoing TAVI. Specifically, the study estimate the burden of~     arrhythmias before TAVI and to accurately determine the incidence of new onset atrial~     fibrillation and complete AV-block within 12 months after the procedure. Identifying patients~     at risk for AV- conduction abnormalities, atrial fibrillation (AF), and non-sustained or~     sustained ventricular arrhythmias may guide future preventive measures, medical treatment and~     improve patients outcomes after TAVI.~   "
77009|NCT02558998|"~     The objective of this study is to 1) evaluate the impact of a novel individualized care~     planning/ educational technology (the On Q Care Planning System or CPS) on oncology patient~     and provider knowledge, attitudes and beliefs about Non-Small Cell Lung Carcinoma (NSCLC)~     clinical trials, as well as 2) to evaluate the impact of the On Q CPS on patient referral to~     and enrollment in NSCLC clinical trials.~   "
77010|NCT02558985|"~     No interventions outside the normal course of patient care. The investigators will be~     collecting data at specified points throughout the casting process.~      The proposed study will measure lung compliance during the casting process for spinal~     manipulation. Research questions include: Is there a quantifiable change in lung compliance~     during the casting process? Is there an individual change in lung compliance over time~     comparing collection points at each cast change? Is there a change in appearance of~     flow-volume loop? Is there a decrease in oxygen saturation from post-induction baseline? The~     investigators hypothesize that there is a change in lung compliance and a decrease in oxygen~     saturation during the casting process.~   "
77011|NCT02558972|"~     Vasovagal syncope (VVS, simple faint) is the most common cause of transient loss of~     consciousness and represents the acute episodic form of orthostatic intolerance (OI).~     Postural tachycardia syndrome (POTS) is the common chronic form of OI. Both are defined by~     debilitating symptoms and signs while upright relieved by recumbency. Northera should~     therefore improve both sympathetic splanchnic arterial vasoconstriction and sympathetic~     splanchnic venoconstriction in POTS and VVS, and may represent an ideal drug to improve the~     orthostatic response in POTS and VVS.~   "
77012|NCT02558959|"~     This study is designed to investigate the effect of second-line irinotecan and capecitabine~     versus irinotecan alone for gemcitabine and cisplatin refractory advanced biliary tract~     cancer patients.~   "
77013|NCT02558946|"~     The purpose of this study is to determine if pelvic floor muscle training with a physical~     therapist before and after surgery will improve health-related quality of life following~     robot-assisted radical prostatectomy.~   "
77014|NCT02558933|"~     The flavonoid epigallocatechin gallate (EGCG) is a modulator of neuronal plasticity useful in~     other neurodevelopmental diseases. A recent study showed that EGCG is a promising tool for~     cognitive and health related quality of life improvement in Down's syndrome.~      The objective is to determine the efficacy of EGCG as a therapeutic candidate for the~     improvement of cognitive performance in FAS patients.~      Pre and post study, non randomized, controlled and without placebo, to evaluate the efficacy~     of EGCG. It is a pilot study in a cohort of 40 FAS children, between 7 ans 14 years old. An~     oral dose of 9 mg/Kg/day will be administered during 1 year, with 6 control visits until 6~     months after finishing the treatment.~   "
77015|NCT02558920|"~     Sugars have been implicated in the epidemics of overweight and obesity. This view is~     supported by lower quality evidence from ecological observations, animal models, and select~     human trials. Higher level evidence from controlled trials and prospective cohort studies has~     been inconclusive. Whether sugars contribute to weight gain or increases in adiposity~     independent of their calories and whether important food sources other than SSBs are~     associated with a higher risk of overweight and obesity remain unclear. To address the~     uncertainties, the investigators propose to conduct a series of systematic reviews and~     meta-analyses of the totality of the evidence from controlled trials and prospective cohort~     studies to distinguish the contribution of fructose-containing sugars and important food~     sources of added sugars (SSBs, pure fruit juice, cakes/sweets, yogurt, cereals, etc) from~     that of energy in the development of overweight and obesity. The findings generated by this~     proposed knowledge synthesis will help improve the health of consumers through informing~     evidence-based guidelines and improving health outcomes by educating healthcare providers and~     patients, stimulating industry innovation, and guiding future research design~   "
77016|NCT02558907|"~     Compare neurocognitive testing MMSE (Mini-Mental State Examination) and MoCA (Montreal~     Cognitive Assessment) to candidates aged patients with 1st line treatment of their cancer~     will be received an examination oncogériatric~   "
77017|NCT02558894|"~     A Phase II Open-Label, Multi-Center Study of MEDI4736 Evaluated as Single Agent or in~     Combination with Tremelimumab in Patients with Metastatic Pancreatic Ductal Adenocarcinoma.~   "
77018|NCT02558881|"~     France is among the countries with a high incidence of colorectal cancer. The prognosis~     associated with colorectal cancer is related to the development stage of the disease at~     diagnosis. Thus, when the cancer is detected and treated at an early stage, the survival rate~     at 5 years was 90%. It is therefore a major issue of screening is widespread in France since~     the end of 2008.~      This screening is based on a two step strategy: 1) the occult blood in the stool (FOBT) and~     if positive 2) the realization of an optical colonoscopy examination currently regarded as~     the evaluation procedure colon reference. But as part of this organized screening, 13% of~     those with a positive FOBT ultimately refuse to have an optical colonoscopy. Under the~     refusal, virtual colonoscopy may be proposed as an alternative according to the~     recommendations of the National Health Authority in 2010. But it has never been assessed as~     part of organized screening. Similarly another alternative is recently developed colic~     capsule that benefits of development in recent years of the capsule for the small intestine~     which has become the gold standard for diagnosis of most diseases of the small intestine~     (bleeding occult, diagnosis of unknown colitis...).~      Therefore the study proposes virtual colonoscopy or colon capsule for people with a positive~     FOBT as part of organized screening and did not realize optical colonoscopy after the usual~     procedure and complete recovery. This study aims to answer the question of the place of colic~     capsule as part of organized screening. An economic component is integrated to assess, in~     terms of health insurance, the cost associated with these two exams, and compare them to the~     cost of optical colonoscopy.~      The proposed study is an observational study of impact of an alternative screening strategy~     for colorectal cancer whose primary objective is to compare the rate of acceptance of virtual~     colonoscopy and colon capsule in patients refusing optical colonoscopy.~   "
77021|NCT02558842|"~     Brazil ranks 17th among the 22 countries responsible for 80% of tuberculosis (TB) cases in~     the world. In 2010, the number of new cases of tuberculosis in Brazil was 71,930 and in 4972~     RS. In 2010, Brazil had a disease incidence of 37.6 / 100,000 in 2011 fell to 36.0 / 100,000.~     The Rio Grande do Sul(RS)S showed an incidence rate of 46.1 / 100,000 in 2011. The mortality~     rate was 2.4 / 100,000 population per year in Brazil and RS.~      In Porto Alegre, the incidence rate of all clinical forms of tuberculosis has remained, in~     the last six years, around 100/100.000 inhabitants per year, while the coefficient of~     pulmonary tuberculosis remained on average 50/100.000 inhabitants to year. Thus, Porto Alegre~     holds the 2nd place in Brazil among the capitals with the highest incidence of TB,~     classifying the city as high risk 5th. Porto Alegre also has a co-infection TB / HIV from~     35.3% one of the highest in the country.~      The best strategy to prevent new cases of tuberculosis is to invest in early diagnosis and~     effective treatment of existing cases of the disease. As the treatment of the disease~     requires daily use of medications for an extended period of time (at least 6 months),~     adherence becomes the main determinant of the rate of healing of disease.~      There are several factors that contribute to poor adherence and treatment dropout:~     alcoholism, illicit drug use, infection with human immunodeficiency virus (HIV Human~     Immunodeficiency Virus), low education, unemployment, poor housing and prolonged the~     treatment. The irregular treatment and neglect are the major obstacles to the control and~     elimination of this disease.~      Study in Porto Alegre pointed alcoholism, TB / HIV, the fact that the patient does not reside~     with family and low education as predictors of dropout. The dropout rate in the general~     population of patients with active tuberculosis was 10.7% (8.0% - 17.0%). Abandonment~     occurred more often within the first three meses8.~      In Porto Alegre, 32.5% of new TB cases are diagnosed in hospitals. Twenty percent of these~     patients do not bind, after discharge, the Tuberculosis Control Program (TCP), ie, the~     patient egress from the hospital does not reach the basic health unit (BHU) reference for~     further monitoring and treatment, which is considered a serious flaw in the process control~     of the disease.~   "
77022|NCT02558829|"~     The Macimorelin Growth Hormone Stimulation Test (GHST) will be compared with the Insulin~     Tolerance Test (ITT) in an open-label, randomized, 2-way crossover Trial. The trial will~     include subjects suspected to have adult growth hormone deficiency (AGHD) and a group of~     healthy control subjects.~   "
77023|NCT02558816|"~     This is an open label, multicenter, fixed dose and dose escalation, phase I/II study.~      The study will be conducted into 3 steps. The first one will be to ensure the safety of the~     combination of Obinutuzumab (GA101) and Ibrutinib at fixed doses in patients with relapsed or~     refractory Mantle Cell Lymphoma (MCL).~      A total of 9 patients will be included in this first step (step A) with grouped inclusions of~     three patients (a safety evaluation will be performed at each inclusion of 3 patients).~      The second step (step B) will be conducted if no unacceptable toxicity is observed during the~     first step and 24 new patients will be included in the step B. The aim of the second step is~     to determine the MTD of the GDC-0199 in combination of GA101 and Ibrutinib (both respecting~     the previous doses) by using a Continual Reassessment Method.~      The third step (step C) will be conducted if no unacceptable toxicity is observed during the~     second step. The aim of the third step is to confirm the safety profile of the combination of~     GA101 + Ibrutininb + GDC-199 at dose determined according to step B result in patients with~     untreated Mantle Cell Lymphoma (MCL). 15 patients will be included in this step.~   "
77024|NCT02558803|"~     Randomized, 2-arm observational study. The 2 arms (randomized at the level of health care~     provider) will be: 1. usual practice; 2. automated reminders to recommend 2nd and 3rd doses~     of HPV vaccine for eligible male and female adolescents who have initiated vaccination.~   "
77025|NCT02558790|"~     This study is a 12-week, open-label pilot study to test the effects of MMFS-201-301 on~     cognition and function in adults with ADHD. Subjects may enter the trial on a stable dose of~     medication for ADHD, and MMFS-201-301 will be given. Subjects who do not enter on a stable~     dose of ADHD medication will receive MMFS-201-301 alone.~   "
77026|NCT02558777|"~     Objectives: To analyze if a multicomponent nurse-led intervention randomized clinical trial~     (MID-Nurse Study) is feasible (Pilot study), and can reduce the incidence, duration, and~     severity of delirium in hospitalized older adults in an AGU.~      Design: Parallel-group Double-blind Randomized Clinical Trial (Pilot Study). Setting: AGU~     Complejo Hospitalario Universitario from Albacete (Albacete, Spain).~      Participants: 50 patients ≥ 65 years hospitalized in the AGU (21 intervention group, 29~     control group).~      Interventions: After risk factor analysis, all participants in the intervention group (IG)~     received a daily multicomponent intervention (orientation, sensorial deficit, sleep,~     mobilization, hydration, nutrition, drugs, elimination, oxygenation, pain) by the~     intervention nurses. The control group (CG) received usual care.~      Measurements: Delirium presence was determined daily with the Confusion Assessment Method~     (CAM), and delirium severity with the Delirium Rating Scale-Revised-98 (DRS). Mortality, days~     of hospitalization, use of physical restraint measures, and use of drugs for delirium control~     (neuroleptics and benzodiacepines) were also recorded.~   "
77027|NCT02558764|"~     Advances in surgical techniques and immunosuppression (IS) have led to an appreciable~     reduction in postoperative complications following kidney transplantation. However, surgical~     site events (SSE) including surgical site infections (SSI) and other wound complications are~     still very common and they can limit these improved outcomes and result in prolonged~     hospitalization, hospital readmission and reoperation, consequently increasing overall~     transplant cost.~      Negative pressure wound therapy (NPWT) is a concept introduced initially to assist in the~     treatment of chronic open wounds. This technique uses a negative pressure unit and specific~     dressings that help to hold the incision edges together, redistribute lateral tension, reduce~     edema, stimulate perfusion and protect the surgical site from external infectious sources.~     Thus, it provides faster wound healing and shortens hospital stay.~      Recently, there has been growing interest in using portable NPWT devices on closed incisions~     after surgery to prevent potential SSI and other wound complications in high-risk patients.~     Investigations regarding this technique in various surgical settings have shown that it can~     reduce the risk of SSI and other wound complications. These studies concluded that any~     patient undergoing transplantation should be considered as 'high-risk' and should receive~     this treatment.~      To date, no studies are reported in literature exploring the effects of preventive use of~     portable NPWT devices on surgical wounds in the setting of organ transplantation. The aim of~     our study is to compare a portable NPWT device (PICO, Smith & Nephew, London UK) to~     conventional gauze dressings in patients undergoing kidney transplantation (KT) surgery.~   "
77030|NCT02558725|"~     Since normal pregnancies are associated with dilutional anemia, due to a greater increase in~     plasma volume with a smaller increase in RBC mass, it is important to properly diagnose IDA~     according to the levels of serum ferritin. Previous studies examining the optimal iron dose~     have shown that adjustment of iron supplementation according to serum ferritin levels in~     early pregnancy could be beneficial. Nonetheless, there is no consensus regarding the~     appropriate dose of iron during pregnancy, its dose-response curve and its effect on serum~     ferritin levels.~      In this trial the investigators sought to assess the efficacy of doubling the daily iron~     supplement dose in pregnant women with IDA.~   "
77036|NCT02558647|"~     This first aim of this study is to evaluate the effect of a cost-effective, more accessible~     alternative treatment approach for insomniacs. Traditional CBT-I has been adapted to an~     online intervention system, so individuals can access a personalized treatment when they~     want. This newly developed web-based computer technology has produced remarkable preliminary~     results, comparable to the results one can achieve when delivering CBT-I in a face-to-face~     format. The current project will test this approach for use on a population scale. Of the 13~     500 participants reporting symptoms of insomnia in HUNT3, 1500 will be randomized into CBT-I~     or a placebo control group. The large scale of this trial will allow detailed analyses of~     subgroups (insomniacs with comorbid conditions), which has not been possible in the previous~     small clinical trials. The upcoming HUNT4 in 2017-2018 will together with data from FD-Trygd~     provide unique long-term FU-data on both a range of health parameters and employment status.~     The second aim is to use the HUNT3 Biobank to examine how genes may be related to insomnia.~     Our study will also be the first of its kind to examine if genes may predict the outcome for~     individuals in the treatment study.~   "
77037|NCT02558634|"~     Laryngeal Dystonia (LD), also commonly referred to as spasmodic dysphonia, is a neurological~     voice disorder characterized by involuntary dystonic contractions of the laryngeal muscles.~     Current treatments such as botox and voice therapy only provide temporary relief and thus,~     the investigators are exploring new strategies to provide long-term, sustained improvement.~      Deep Brain Stimulation (DBS) is a neurosurgical procedure that involves the implantation of~     electrodes to deliver electrical stimuli to specific brain regions. It is the standard~     surgical treatment for many other movement disorders such as Parkinson's disease, essential~     tremor, and primary dystonia. This trial has been designed to test the hypothesis that DBS~     can improve the vocal dysfunction of LD.~   "
77038|NCT02558621|"~     The main objectives of the study are to evaluate the acceptance into operating flow,~     performance and safety of the AQrate Robotic Assisted System during the spinal fusion surgery~   "
77039|NCT02558608|"~     This subject analysis of the influence of the dissociating inferior pulmonary ligament on~     pulmonary reexpansion and recurrence in the treatment of primary spontaneous pneumothorax by~     video assisted thoracic surgery. All patients are randomly divided into two groups: group A~     and group B. Wedge resection(WR) will be performed for all patients. Investigators dissect~     the inferior pulmonary ligament(DIPL) for group A. Investigators do not dissect the inferior~     pulmonary ligament for group B. The pulmonary reexpansion and recurrence rate are observed~     between the two groups.~   "
77040|NCT02558595|"~     The purpose of this study is to observe the effects of niacinamide on markers of kidney~     injury, inflammation, kidney cyst growth and kidney function.~   "
77041|NCT02558582|"~     Pulmonary Hypertension (PH) is a serious disease with a dismal prognosis when left untreated.~     Advances in medical therapy have improved survival according to recent registries and~     systematic reviews, but are associated with high healthcare costs.~      Earlier studies in Heidelberg, Germany showed good evidence for the effect of exercise~     training on improving exercise performance, quality of life and pulmonary hemodynamics in~     patients with pulmonary hypertension.~      The main objectives of the present project are:~        1. to investigate the quality of the implementation of a standardized 3 week in-hospital~          exercise training program on markers of outcome and disease severity in PH-patients in~          Switzerland immediately after training and after 3 and 12 month.~        2. to look whether training with hyperoxia vs. standard care might be more effective.~      This is a multicentre, randomized parallel-group trial where the intervention rehabilitation~     is delayed in one group so that they can serve as standard care controls for the others.~      In a nested single-centre randomized-controlled trial patent will additionally be randomized~     to receive either usual rehabilitation (UR) or rehabilitation with standardized supplemental~     oxygen therapy (SSOT) during nights and ergometer training.~      Patients will receive a PH specific rehabilitation program during 3 weeks followed by an~     instructed home-based training program for 12 weeks. Patients who are not already under~     long-term oxygen therapy (LTOT) due to daytime hypoxemia will additionally be randomized to~     receive standardized supplemental oxygen therapy (SSOT) during training and nights upon~     written informed consent.~   "
77042|NCT02558569|"~     This study evaluates the use of fentanyl during craniotomy in two groups of brain tumor~     patients. The control group will receive standard general anesthesia with the use of fentanyl~     for intraoperative pain control and the study group will receive scalp nerve block with 0.5%~     levobupivacaine (local anesthetic) and also fentanyl for intraoperative pain control. The~     scalp nerve block might reduce the dose of fentanyl and promote faster emergence from general~     anesthesia.~   "
77043|NCT02558556|"~     Rationale: Several clinical feasibility studies have shown the potential benefit of~     near-infrared fluorescence (NIRF) imaging using indocyanine green (ICG) for enhanced and~     earlier biliary anatomy visualization during laparoscopic cholecystectomy with the aim to~     reduce the number of vascular and biliary injuries. Although the incidence of injuries is low~     (0.7%), the impact on patients in terms of morbidity, quality of life and costs are dramatic.~     The Critical View of Safety (CVS) technique is regarded as the safety valve in conventional~     laparoscopic cholecystectomy (CLC). It is hypothesized that standard application of~     near-infrared fluorescence imaging during laparoscopic cholecystectomy can be useful to~     obtain establishment of CVS (at least 5 minutes) earlier and with more certainty regarding~     visualization when compared to conventional laparoscopic imaging alone.~      Study design: A multicenter randomized controlled trial with two study arms. Patients~     scheduled for an elective laparoscopic cholecystectomy will be recruited and randomized at~     the outpatient clinic (n = 308 total). One group will undergo near-infrared fluorescence~     cholangiography assisted laparoscopic cholecystectomy (NIRF-LC) and the other group will~     undergo conventional laparoscopic cholecystectomy (CLC).~      Compared with standard care, patients in the NIRF-LC group have to receive one preoperative~     intravenous injection of ICG. This is the only additional minimally invasive action for the~     patient. Initially, patients participating in this study will not benefit from the~     application of NIRFC during the surgical procedure. The administration of ICG and the~     modified laparoscope itself are not related with any kind of additional risk for the patient.~      Despite the encouraging results from several (pre)clinical feasibility studies, wide clinical~     acceptance of the routine use of ICG fluorescence laparoscopy is still lacking due to the~     absence of reliable and validated clinical data. A randomized clinical study is desirable to~     assess the potential added value of the NIRF imaging technique during laparoscopic~     cholecystectomy. Strong evidence in favor of routine implementation of this new imaging~     technique during laparoscopic cholecystectomy, will probably lead to worldwide routine~     application of the NIRF technique. Therewith long term sustainability of this research~     project is guaranteed.~   "
77086|NCT02557997|"~     We aim at comparing markers of HIV reservoir, monocyte function and immune activation between~     antiretroviral therapy (ART)-naïve (chronic infection or primary infection), ART-controlled~     or ART-failing HIV infected adults initiating a dolutegravir (DTG)-based regimen. The~     investigators' purpose is to measure cell associated HIV-1 DNA, monocyte function [soluble~     CD14 (sCD14), soluble CD163 (sCD163)], and immune activation [neopterine, interleukin-6~     (IL-6) and high-sensitivity C-reactive protein (hsCRP)] biomarkers at different time points~     between baseline and week 48 post DTG-based regimen initiation in each group.~   "
77044|NCT02558543|"~     Systemic sclerosis (SSc) is an auto-immune orphan disease mainly characterized by an~     alteration of the microvascular network, and by cutaneous and visceral fibrosis. Hands are~     frequently affected, as a consequence of ischemic phenomena and cutaneous fibrosis.~      . The injection of adipose autologous tissue is a common practice in plastic surgery, and has~     been known for over a century. Adipose tissue, originally used to increase volume, is also~     characterized by trophic properties associated to stromal vascular fraction (SVF), which~     contain multipotent stem cells, capable of tissue repair. Interestingly, some SVF cells can~     be angiogenic and anti-inflammatory, which could improve damage seen with SSc.~      A prior study (the SCLERADEC protocol: ClinicalTrials.gov NCT01813279) has already allowed~     the safety and tolerance at 6 months of the subcutaneous injection of SVF in the fingers of~     twelve patients to be proven.~      The encouraging results have encouraged us to propose a trial which would bear on a higher~     number of patients and include a control group.~   "
77045|NCT02558530|"~     The major adverse health consequences of obesity occur only when non-alcoholic fatty liver~     disease (NAFLD) also develops. NAFLD is characterized by abnormal hepatic accumulation of~     triglycerides and other lipids. The first-line approach to NAFLD management is caloric~     restriction and weight loss, but these remain difficult to achieve. Little attention has been~     given to dietary carbohydrate restriction, despite recent reports showing that hepatic de~     novo lipogenesis, a process that converts dietary carbohydrates into fatty acids in the~     postprandial state, accounts for approximately 25% of liver triglyceride content in~     hyperinsulinemic subjects with NAFLD. For comparison, only 15% of the liver triglycerides~     were derived from dietary fatty acids in patients with NAFLD who had consumed a standardized~     30% fat diet for four days before being assessed.~   "
77046|NCT02558517|"~     Systemic Lupus (SLE) is a chronic disease for which long term treatments are warranted. The~     aim of this study was to study the possibility of corticosteroids interruption in patients~     with quiescent SLE treated since at least one year with 5 milligrams of predonisone per day.~   "
77047|NCT02558504|"~     First intent treatment for superficial circular esophageal neoplasm is surgical resection.~     Endoscopic mucosal resection is not recommended due to the high rate of subsequent esophageal~     stenosis (higher than 80%).~      Surgical limits are related to a high level of morbidity due, in particular, to respiratory~     complications or infections that require prolonged hospitalisations, and by significant rate~     of mortality (from 2 to 5 %). As an alternative to the surgical treatment, an innovative~     technique to remove esophageal circular preneoplastic and neoplastic lesions has been~     developed: it consists to ablate the mucosa by means of a balloon of a fixed diameter which~     incorporates approximately 100 electrodes on its surface that emit radiofrequency waves~     (HALO® Radiofrequency Ablation Technology System). By varying the strength and the duration~     of the electrical impulses, it is possible to obtain a homogenous and controlled destruction~     of the tissue of the whole mucosa, leaving no remaining pre-neoplastic or neoplastic elements~     underneath. The technique will be used for high grade glandular epithelial neoplasia, Vienna~     4-1 or 4-2, developed on a mucosa at risk, i.e. the Barrett's oesophagus, occupying more than~     half of the circumference of the esophagus and that requires surgical treatment. The expected~     benefit for the patient is linked to the reduced invasiveness of the technique in comparison~     to the surgery~   "
77048|NCT02558491|"~     The purpose of this study is to demonstrate the safety and feasibility of a decision support~     system aimed at reducing glucose variability in T1DM patient using an insulin pump.~   "
77049|NCT02558478|"~     Next Generation Sequencing (NGS) strategy is a powerful tool to identify genes implicated in~     very rare diseases for which the previous genetic explorations remain negative to date. The~     aim of this project is based on groups of patients with original clinical phenotypes~     including neurosensory impairment without genetic cause identified to date. The investigators~     will study these families using whole exome sequencing to potentially identify new genes and~     new underlying biological pathways involved in neurosensory diseases.~   "
77050|NCT02558465|"~     The objective of this investigation is to assess safety and effectiveness of Xarelto under~     practice routine use in VTE secondary prevention after acute DVT, focusing on~     hemorrhagic-related AEs, recurrent venous thromboembolism (PE/DVT), all-cause mortality. This~     study is a company sponsored, one- arm prospective cohort study with patients to whom~     Rivaroxaban treatment for VTE (PE/DVT) has been chosen. The study includes a standard~     observation period (1 year) and an extension survey period (2 years, at the longest).~   "
77051|NCT02558452|"~     SENIOR transplant Registry European transplant registry of senior renal transplant recipients~     (above the age of 65 years) receiving initial immunosuppression with tacrolimus once daily,~     mycophenolate and steroids to investigate long term outcomes on an observational basis.~   "
77052|NCT02558439|"~     The purpose of this study is to evaluate the safety and efficacy of a single injection of~     CNTX-4975 in subjects with chronic, moderate to severe osteoarthritis knee pain.~   "
77053|NCT02558426|"~     Chronic Venous Disease (CVD) is a very common problem affecting western adult population. To~     date the pathophysiology of CVD development encloses several theories such as the role of~     extracellular matrix (ECM) components alterations, the alteration of Matrix~     Metalloproteinases (MMPs) and other related molecules, the endothelial dysfunction, and~     several genetic factors but none of these could properly explain its genesis. Estrogen~     Receptors may be involved in CDV pathogenesis. Endogenous estrogens are important regulators~     of vascular homeostasis and they act mainly via three different ERs which are expressed in~     the cardiovascular system: ERα, ERβ, and a G protein-coupled estrogen receptor termed GPER.~     of this study is to explore the expression of estrogen receptors in vessel wall of varicose~     veins through the entire clinical spectrum of CVD.~   "
77054|NCT02558413|"~     This is a placebo-controlled, double-blind, randomized, single dose escalation Phase 1~     clinical trial to determine the safety and tolerability of BTA-C585 administered orally to~     healthy subjects.~   "
77055|NCT02558400|"~     To evaluate ocular hypotensive efficacy and safety of PG324 Ophthalmic Solution compared to~     Netarsudil (AR-13324) Ophthalmic Solution and Latanoprost Ophthalmic Solution.~      Following completion of the Month 12 study visit procedures, subjects will be offered the~     opportunity to participate in a 2-month observational (i.e., non-interventional) trial~     extension.~   "
77116|NCT02557607|"~     A technique of MRI infusion -l'Arterial Spin Labeling-, non-invasive and non-irradiating,~     repeatable over time, appears promising in the field. This sequence allows for routine,~     generate perfusion maps relating to the entire brain volume~   "
77056|NCT02558387|"~     Recently, sorafenib which can target VEGFR and PDGFR demonstrated 13-16% of response rate in~     patients with recurrent/metastatic salivary gland cancers, suggesting that VEGFR and PDGFR~     might be important role in salivary gland cancers. Accordingly, several trials with various~     anti-angiogenic molecular targeted agents such as dasatinib, dovitinib, or sunitinib in~     salivary gland cancer are ongoing.~      Nintedanib (BIBF1120) is a potent small molecule triple receptor tyrosine kinase inhibitor~     (PDGFR/ FGFR1-2 and VEGFR1-3). VEGFR-2 is considered to be the crucial receptor involved in~     initiation of the formation as well as the maintenance of tumor vasculature. In vitro, the~     target receptors are all inhibited by nintedanib in low nanomolar concentrations. In in vivo~     nude mouse models, nintedanib showed good anti-tumor efficacy at doses of 50-100mg/kg,~     leading to a substantial delay of tumor growth or even complete tumor stasis in xenografts of~     a broad range of differing human tumors.~      Based on this background, in this study, the investigators would like to conduct a phase II~     study of Nintedanib (BIBF 1120) in patients with recurrent or metastatic salivary gland~     cancer of the head and neck to evaluate efficacy and safety.~   "
77057|NCT02558374|"~     To evaluate ocular hypotensive efficacy and safety of Netarsudil (AR-13324) Ophthalmic~     Solution compared to Timolol Maleate Ophthalmic Solution.~   "
77058|NCT02558361|"~     Apremilast (Otezla®) is a Federal Drug Administration (FDA)-approved treatment for psoriatic~     arthritis and psoriasis. Although there are a lot of data demonstrating how apremilast works~     in the laboratory, there are very few demonstrating how it works in the actual target organ,~     i.e. the skin or synovial (joint) tissue in patients with psoriasis and psoriatic arthritis.~      Laboratory data has demonstrated that apremilast decreases inflammatory proteins and~     increases anti-inflammatory proteins. However, almost all of these data/studies have been~     performed on the blood of patients with psoriasis and psoriatic arthritis, not the skin or~     synovial (joint) tissue. These studies that have been performed on the blood of patients with~     this condition may, or may not, reflect the true response to therapy in the synovial (joint)~     tissue and/or skin.~   "
77059|NCT02558348|"~     The purpose of Part 1 (Phase 1b) is to evaluate the general safety and tolerability of~     repeated 21-day cycles of AL3818 therapy, and to reevaluate the maximum tolerated dose (MTD).~      The purpose of Part 2 (Phase 2a) is to evaluate the efficacy of repeated 21-day cycles of~     AL3818 therapy preliminary efficacy of AL3818 in subjects with recurrent or metastatic~     endometrial, ovarian or cervical cancer.~   "
77060|NCT02558335|"~     The purpose of this study is to identify and quantify circulating tumor markers, which are~     associated with the presence of tumors. The current imaging available does not allow~     specificity of tumor size as it relates to pseudoprogression (a temporary enlargement or~     swelling of the tumor after treatment before it shrinks). Our hope is that CTCs will~     provide a more accurate description of tumor state for high grade glioma patients.~   "
77061|NCT02558322|"~     The study explores the variation in the patient populations and describes regional~     differences regarding the reasons for consultations in the primary medical care in Germany.~     The data collection will be stratified by rural and urban areas as well as environs. The data~     set will include a large variety of data about physicians, patients and health care~     utilization.~   "
77062|NCT02558309|"~     The goal of this study is to examine in-vivo the effect of intraocular (IOP) and intracranial~     pressures (ICP) on the optic nerve head (ONH). The effect of ICP on eye health has been an~     area of concrete research effort in recent years. The ability to acquire non-invasive and~     highly detailed information on both the eye and the brain using technologies such as magnetic~     resonance imaging (MRI) and optical coherence tomography (OCT) have paved the way to assess~     non-invasively the effect of ICP in-vivo. In this study, we will quantify the structural~     changes in the ONH in subjects with elevated ICP while they are treated to reduce the~     elevated pressure. This process will occur in a stepwise fashion over a period of time~     determined by the clinical treatment plans. We will apply controlled pressures to the eye~     during each step of ICP lowering while OCT images are obtained.~   "
77063|NCT02558296|"~     The purpose of this study is to investigate the effect of bexagliflozin in lowering~     hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM) and increased~     risk of cardiovascular adverse events.~      The data from this study will be combined with the data from other bexagliflozin studies in a~     meta-analysis of CV safety outcomes.~   "
77064|NCT02558283|"~     This is a safety and efficacy study of JUVÉDERM® VOLIFT® with Lidocaine and Restylane® in~     Chinese adults with nasolabial folds.~   "
77065|NCT02558270|"~     Inhibition of SGLT2 by specific inhibitors has been shown to reduce the renal threshold for~     glucose excretion in patients with type 2 diabetes mellitus (T2DM) and control subjects~     leading to significant renal glucose loss even in the presence of normal glucose~     concentrations. SGLT2 inhibition with canagliflozin induces a 24h urinary glucose loss of~     around 70g in healthy subjects.~      Recent studies indicate that under fasting and postprandial conditions administration of~     SGLT-2 inhibitors leads to increase in endogenous (hepatic) glucose production (EGP)~     potentially counteracting the glucose lowering potency of these drugs. Dapagliflozin has been~     shown to acutely increase endogenous glucose production (EGP) and plasma glucagon~     concentrations under postabsorptive conditions within 2 hours after drug ingestion in~     patients with (T2DM). Glucagon binds to receptors in the liver and activates hepatic~     gluconeogenesis (GNG) and glycogenolysis, likely contributing to the observed increase in~     EGP.~      So far the likely interrelation between acute changes in hepatic glucose metabolism and~     energy turnover contributing to increased hepatic glucose production induced by SGLT2~     inhibition has not been studied. It is known that out of the 80% of oxygen consumption~     coupled to ATP synthesis, 7- 10% is used by GNG. However, so far the effects of dapagliflozin~     on acute changes in gluconeogenesis (GNG) and ATP turnover in hepatic tissue and on the time~     course of hormones involved in hypoglycaemia counter regulation have not been studied.~   "
77085|NCT02558010|"~     Acute pain management following major surgical procedures in pediatric patients continues to~     be a challenge, especially after extensive posterior spine fusions.~      Spine surgery is particularly traumatic, initiating pain in both peripheral and central~     pathways. While the standard management of post-surgical pain involves a multimodal approach,~     opioids provide the predominant benefit. However, opioid use is associated with many adverse~     effects, including nausea, constipation, and pruritus. Perioperative methadone may decrease~     total opioid consumption and adverse effects as well as improve satisfaction with pain~     management after scoliosis repair.~   "
77066|NCT02558257|"~     Objectives:~      Primary Objective The primary objective is to determine patients' perceptions of the~     timeliness of their referral to an outpatient palliative care clinic.~      The secondary objectives are to determine:~        1. The factors and variables associated with perception of timeliness such as age, gender,~          and symptom distress~        2. The patients' perceptions of the physical environment of the outpatient clinic at UT MD~          Anderson Cancer Center (UTMDACC) such as lighting, music, and lack of a waiting room;~          and~        3. If there is an association between level of distress (physical, psychological, and~          spiritual distress as measured by Edmonton Symptom Assessment Scale (ESAS) and the~          usefulness of the referral to palliative care center.~   "
77067|NCT02558244|"~     The aim of this study is to evaluate Image-defined Risk Factors (IDRF) in patients with~     neuroblastoma, at the time of their initial presentation, as a prognostic factor for~     prediction of subsequent outcome & complications related to surgery, in the accordance with~     the experience of South Egypt Cancer Institute (SECI), which is the largest referral site in~     Upper Egypt.~   "
77068|NCT02558231|"~     The objective of this clinical trial is to compare the efficacy and safety of an initial~     triple oral treatment regimen (macitentan, tadalafil, selexipag) versus an initial dual oral~     treatment regimen (macitentan, tadalafil, placebo) in newly diagnosed, treatment-naïve~     patients with pulmonary arterial hypertension.~   "
77069|NCT02558218|"~     Primary objective of the study is the assessment of the patients' discomfort and ocular~     redness following cataract extraction surgery by means of phacoemulsification and intraocular~     lens implantation.~   "
77070|NCT02558205|"~     The purpose of this study is to see if it is possible to establish a relationship between the~     blood flow and blood volume of liver tumors from CT body perfusion and the radiation dose~     deposited in the tumors from the radioembolization treatment as measured by PET/CT.~      The study will do this by:~        1. Measuring the blood flow and blood volume of tumors in the imaging data from a CT body~          perfusion~        2. Measuring the radioactivity in the tumors after the radioembolization treatment using~          PET/CT and then calculating the dose deposited in the tumor~        3. Using statistical analysis to assess the relationship between the dose and the perfusion~          parameters~      In addition, the research may help develop a method for calculating the dose of~     radioembolization to be delivered to a liver tumor(s) using blood volume and blood flow data~     obtained from the CT body perfusion scans.~   "
77071|NCT02558192|"~     Nosocomial infections are infections that occur from the time of 'entry in the hospital up to~     48h after discharge. In most developed countries, the incidence of nosocomial infections in~     children is between 5% and 44% with the predominance of respiratory infections and~     gastrointestinal infections. Nosocomial infections prolong the time of hospital stay, reduce~     the effectiveness of treatment, significantly increasing hospital costs. Current measures for~     prevention of nosocomial infections in pediatrics, such as vaccinations and compliance with~     sanitary regulations, are not fully effective. Therefore it is necessary a deepening of the~     possible methods of prevention, between which has been already tested the use of probiotics~     such as Lactobacillus GG. A recent RCCT, which provided for the administration of LGG against~     placebo, noted a significant reduction in the risk of gastrointestinal infections and~     respiratory infections in hospitalized children treated with LGG, compared with patients who~     received placebo. There are also evidence which demonstrate a potential role zinc in reducing~     the incidence of respiratory infections is that bowel. We thought, therefore, to perform a~     multicenter randomized controlled trial with the aim to evaluate the role of a complex~     containing LGG, vitamins and zinc in the prevention of nosocomial gastrointestinal and~     respiratory tract infections in pediatric wards.~   "
77072|NCT02558179|"~     This study is designed as a prospective evaluation of the diagnostic performance of the~     multiplex nucleic acid-based genetic test (Gynecologene Next-Generation Sequencing test) to~     identify known significant causative organisms in bacterial vaginosis/vaginitis and other~     major pathogens and normal commensals in symptomatic women during the reproductive years.~     Vaginal fluid samples will be split and tested with the comparator methods and Nugent score,~     with the results evaluated according to sensitivity, specificity, positive predictive value,~     and negative predictive value. Laboratorians performing each test will be blinded to the~     clinical history and any prior test results to minimize ascertainment bias.~      Each subject will be followed routinely for up to 6 weeks after initial visit for~     vaginosis/vaginitis by telephone or office visit at the discretion of the treating physician.~   "
77073|NCT02558166|"~     This study consists of two substudies.~      The first substudy:~      'Renal resistive index in critically ill patients with cardiogenic and septic shock'~      Design: cross-sectional observational~      Aim of this project is:~        1. to determine whether critically ill patients with cardiogenic and septic shock have an~          elevated Renal Resistive Index and~        2. to determine whether Renal Resistive Index differs between cardiogenic/hypovolemic shock~          and shock due to sepsis/systemic inflammation (SIRS)~        3. to determine the relation between the (change in) renal vascular resistance and~             -  Markers of the systemic - and the microcirculation~             -  Fluid status as quantified by bioimpedance analysis~             -  Concomitant renal function~      The second substudy:~      'Predictive value of the Renal Resistive Index on ICU admission and its course for the~     development of acute kidney injury in critically ill patients with cardiogenic and septic~     shock'~      Design: longitudinal observational~      The aim of this project is:~        1. to determine whether the renal resistance index on admission to the intensive care unit~          can predict the development of acute kidney injury (AKI) in critically ill patients with~          shock~        2. to investigate if the renal resistance index on admission to the intensive care unit is~          an independent predictor of the development of AKI or depends on the severity and~          duration of shock and other known risk factors of AKI such as comorbidity and use of~          nephrotoxic drugs~      Aim of the large research project is to determine whether the Renal Resistive Index could~     become a monitoring tool for intervention studies aiming to prevent acute kidney injury or~     protect the kidney.~   "
77074|NCT02558153|"~     A multicenter randomized clinical trial of paclitaxel drug-eluting balloon (DEB) versus~     standard percutaneous transluminal angioplasty (PTA) to reduce restenosis in 150 patients~     with haemodialysis access stenoses.~   "
77117|NCT02557594|"~     This Phase I clinical study is to evaluate the safety and pharmacokinetics of DA-2802 319mg~     and Viread 300mg after a single oral dose in healthy male volunteers.~   "
77075|NCT02558140|"~     This first-in-human study consists of three parts. The primary purpose of Part 1 is to~     characterize the safety and tolerability of RO6874813 in participants with locally advanced~     and/or metastatic solid tumors whose disease has progressed despite standard therapy or for~     whom no standard therapy exists. In addition, the maximum tolerated dose (MTD) and/or~     recommended Phase 2 dose (RP2D) will be determined. In Part 2 the safety and tolerability of~     RO6874813 will continue to be characterized in participants with locally advanced and/or~     metastatic solid tumors known to be fibroblast activation protein-alpha positive (FAP+). In~     addition, treatment-induced efficacy of RO6874813 will be assessed by functional imaging and~     paired tumor biopsies. The primary purpose of Part 3 is to demonstrate anti-tumor activity of~     RO6874813 in participants with recurrent or metastatic FAP+ sarcomas.~   "
77076|NCT02558127|"~     The combination of asthma and being a carrier of genetic variants (mutations and / or~     polymorphisms) in the CFTR gene variant would cause bronchial asthma with mucus~     hypersecretion. This phenotype is characterized by a more severe disease, in terms of~     control, quality of life, exacerbations and lung function, and a different asthma the~     bronchial hypersecretion without inflammatory phenotype.~   "
77077|NCT02558114|"~     The purpose of the study is to compare the efficacy, safety and recurrence rate of two~     therapeutic strategies with ribavirin in patients with chronic hepatitis E and severe acute~     hepatitis E: fixed duration of treatment for 12 weeks vs variable duration depending on the~     viremia within 4 weeks of the start of treatment (12 vs 24 weeks).~      The purpose of the study is also improve the safety of treatment with Ribavirin by optimizing~     dose adjusted to renal function, plasma levels of drug and hemoglobin.~   "
77078|NCT02558101|"~     This study tests the impact of a novel invitation strategy on attendance rates to a pre-lung~     cancer screening lung health check appointment. Patients will be individually randomised~     (1:1) to receive either control invitation materials or intervention invitation materials.~     Those who attend will undergo a lung health check and be invited to a baseline screening~     scan if eligibility criteria are fulfilled.~   "
77079|NCT02558088|"~     The objective of the study is to help establish a urinary threshold for salmeterol on the~     World Anti-doping Agency prohibited list, to avoid supratherapeutic of this substance in~     competitive sports.~      Hence, there is no hypothesis as such.~   "
77080|NCT02558075|"~     Large scale, effective, low-cost, and evidence-based programs that can nimbly translate new~     research discoveries into prevention and care for psychosocial based problems are urgently~     needed. This study hopes to provide support for Mood-Lifters, a template for a low-cost~     evidence based program, so that investigators may fill this gap and relieve suffering for~     millions of people who are not getting adequate mental health care. Mood-Lifters provides a~     low cost, research based program designed to enrich people's lives and reduce psychological~     distress. It is designed to provide useful support, coaching and information. It seeks to~     help people enhance pleasure, engagement and meaning in their lives while minimizing~     depression, fear, loneliness and other negative feelings via a proprietary peer based program~     that offers weekly meetings and other flexible support options. The goal of this pilot study~     is to test the efficacy of this program. This is not traditional therapy, rather an~     educational supportive program similar to WeightWatchers, but for mental health.~   "
77081|NCT02558062|"~     Critically ill patients are often ventilated in dedicated critical care units to provide~     respiratory support. Despite best practice patients can often develop a condition called~     adult respiratory distress syndrome (ARDS), which is characterised by deterioration in their~     respiratory function, and changes on chest x-ray. The correct management for ARDS is~     identifying the underlying condition causing the deterioration and identifying appropriate~     targeted therapy. One such cause is pneumonia, caused by a bacterial infection in the lungs~     of a ventilated patient. The patients may have been ventilated due to pneumonia but they may~     also develop pneumonia whilst ventilated. Ventilator associated pneumonia (VAP) has~     significant mortality.~      Despite all the clinical and laboratory data at the investigators' disposal there remains~     great difficulty in the accurate diagnosis of pneumonia and therefore treatment is often~     given empirically. Therefore, there is an urgent clinical need for accurate methods to~     diagnose the presence of bacteria deep in the lung in ventilated critically ill patients. As~     such, the investigating team have developed and synthesised an imaging agent called BAC ONE.~     BAC ONE will be instilled directly into the lungs of 12 patients (with and without lung~     infection) to assess whether it can label bacteria in the human lung.~   "
77082|NCT02558049|"~     BACKGROUND: Proton pump inhibitors (PPIs) treat problems such as gastroesophageal reflux~     disease (GERD). In many patients with mild or moderate GERD, PPIs should be used for 1-2~     months but are often continued longer unnecessarily. This is a problem because PPIs may cause~     harm when used long-term. PPI use is associated with severe C. difficile infections,~     fractures and pneumonia. Canada's public drug programs spent $247 million on PPIs in 2012~     (not including Quebec or PEI). Due to concerns with long-term PPI use, patients may face the~     decision to continue their PPI, use a lower dose or stop and use on-demand (only when~     symptoms return). This decision should be made collaboratively between patients and~     clinicians, though patients tend to have a poor understanding of when reducing a drug is~     appropriate. Using a lower dose or using on-demand may be viewed as difficult because of the~     chance of symptoms returning. Patient decision aids (PDAs) inform patients on benefits and~     risks of treatment options and improve ability to make informed decisions and clarify values.~     OBJECTIVES: Develop a PDA to help patients with the decision to continue PPI or stop and use~     on-demand/use a lower dose. Evaluate whether: 1) the PDA changes patient preference to~     continue or stop and use on-demand/use a lower dose of PPI 2) the PDA improves patient~     knowledge and realistic expectations 3) patients and pharmacists feel they made a shared~     decision 4) there is a change in PPI prescribing 8 weeks post-PDA and 5) patients' choices~     match up with their values. METHODOLOGY: The PDA will be developed by a team of doctors,~     pharmacists and patients. It will be delivered during a visit with a pharmacist. Patients~     (n=54) will indicate which choice they prefer (continue PPI/stop or use lower dose) before~     and after going through the PDA. We will use Mcnemar's test to compare the number of patients~     preferring to continue their PPI before and after. We will evaluate whether there is a~     difference in knowledge test scores and expectations test scores before and after the PDA.~     After the PDA, we will ask patients and pharmacists to rate the extent to which shared~     decision making occurred and measure the agreement. Values/choice congruence will be~     evaluated using logistic regression. Eight weeks after patients have received the PDA, we~     will look at whether there is any reduction in PPI use.~   "
77083|NCT02558036|"~     Optimal patient head and neck position when performing videolaryngoscopy for endotracheal~     intubation has not yet been established.The investigators aim to assess the effect of two~     different positions on the laryngeal view obtained and success of tracheal intubation during~     videolaryngoscopy with two commercially available and well established videolaryngoscopes.~   "
77118|NCT02557581|"~     The role of cAMP signaling mediated by beta2-adrenergic stimulation with agonists has been~     well-studied in skeletal muscles of animals. Studies in humans are scant and the scope of the~     present study is thus to investigate the role of cAMP signaling by beta2-adrenergic~     stimulation for muscle adaptations in humans.~   "
77087|NCT02557984|"~     The purpose of this study is to determine how the dopamine and opioid system is involved in~     reward processing, specifically in cue-induced reward responding and reward impulsivity,~     using dopamine and opioid receptor antagonists in healthy participants. The investigators~     predict that particularly the dopamine challenge should alter cue-induced reward responding~     and reward impulsivity. Such effects would be of high interest for the treatment of disorders~     which involve impairments of reward processing such as addiction.~   "
77088|NCT02557971|"~     This study is a retrospective chart review of patients treated with BOTOX® for idiopathic~     Overactive Bladder (OAB) as standard of care in clinical practice. The study will determine~     the rate of post procedural urinary retention requiring catheterization and identify factors~     that may predict urinary retention.~   "
77089|NCT02557958|"~     Chronic Obstructive Pulmonary Disease Transcription Factor and Cytokine Study.~   "
77090|NCT02557945|"~     The purpose of this study is to test the effects of the drug gabapentin on brain function~     thought to be important in the development of schizophrenia. Researchers think that treating~     a brain region with gabapentin (the hippocampus) may reduce the risk for developing~     schizophrenia.~   "
77091|NCT02557932|"~     In this randomized controlled trial, we investigate the effect of 10-day bismuth quadruple~     therapy in comparison with that of 7-day PPI-based standard triple as 1st line treatment for~     H. pylori.~   "
77092|NCT02557919|"~     This project proposes to evaluate the effectiveness of training Head Start staff to discuss~     tobacco use, shs reduction and cessation in their existing encounters with parents in~     reducing tobacco use and exposure. Understanding the facilitators and barriers to integrating~     the intervention into the Head Start system will support future efforts to address tobacco~     use and exposure in families with small children.~   "
77093|NCT02557906|"~     Some women with breast cancer have their whole breast removed as part of their treatment~     (mastectomy). Of these women, around 31% have more surgery to create a new breast.There are~     two main ways to create a new breast(i)using tissue from elsewhere on the body (autologous~     reconstruction )or (ii)using a silicone implant.~      In recent years, it has been reported that by using a material called an acellular dermal~     matrix (ADM) the results of breast reconstruction surgery using an implant can be improved.~     ADMs are materials which originally come from animal or human skin. They act like a sling,~     supporting the lower part of an implant beneath the skin.~      Although ADMs have been approved for used in breast reconstruction and are safe, there is~     very little high quality evidence to back up their reported benefits, and some studies have~     suggested their use may in fact increase complications.~      The main purpose of this study is to find out what the actual risks and benefits of using an~     ADM in breast reconstruction surgery are. The investigators will follow the progress of women~     who have an implant based reconstruction to observe if participants develop problems; what~     those problems are and how participants feel about the results of their surgery. The~     investigators also follow the progress of women who undergo autologous reconstruction or~     alternative reconstructive techniques using an implant for the same reasons.~   "
77094|NCT02557893|"~     Pregnant women at increased risk for back pain were studied during the second trimester and~     randomized to12-weeks of resistance exercise, education or waitlist. Several outcomes were~     assessed including physical function, quality of life and mood.~   "
77095|NCT02557880|"~     The purpose of this study will be to see if adolescents can advance bedtime above what can be~     accomplished by counseling alone simply by inputting their information into a sleep~     application diary and reporting this information back to their sleep doctor.~   "
77096|NCT02557867|"~     The purpose of this study is to study the effect of obesity in dexmedetomidine~     pharmacokinetics and pharmacodynamic profile.~   "
77097|NCT02557854|"~     The purpose of this study is to determine whether Doxil (liposomal doxorubicin) given prior~     to MR-HIFU Hyperthermia is safe for the treatment of pediatric and young adult patients with~     recurrent and refractory solid tumors.~   "
77098|NCT02557841|"~     A crossover trial with healthy volunteers will be conducted. Three sessions will be performed~     with at least 48 hours washout period to minimize carry-over effects. In each session,~     volunteers will be submitted to: fatigue and attention levels evaluation, handwriting test,~     serial reaction time task (SRTT) before and after ctDCS conditions and after session, a~     performance perception evaluation.~   "
77099|NCT02557828|"~     Invasive blood pressure monitoring is achieved by cannulating an artery and transducing the~     pressure. During arterial cannulation the artery can be located by palpation, but use of~     ultrasound has increased the success rate of cannulation. A new ultrasound technique for~     vascular cannulation (dynamic needle tip positioning) has been described. Investigators aim~     to compare this technique to the palpation technique for arterial cannulation. Investigators~     hypothesize that the use of this novel ultrasound technique will result in a higher first~     attempt success rate and overall success compared to palpation.~      Investigators plan to enroll 310 patients in this study. The participants in the study will~     have been deemed by the attending anesthesiologist to require a radial arterial line for the~     operation and thus the research protocol will not involve a deviation from the standard of~     care.~   "
77100|NCT02557815|"~     This current project investigates the effect of a single session of right dlPFC repetitive~     transcranial magnetic stimulation on emotion regulation abilities and craving in alcohol~     dependent patients and healthy controls.~   "
77129|NCT02557438|"~     The purpose of this study is to examine the impact of weight-loss surgery (Roux-en-Y gastric~     bypass or Vertical Sleeve Gastrectomy) on bone outcomes in girls and boys ages 13-21. This~     study will also examine a group of overweight boys and girls who are not scheduled or planned~     for surgery for comparison of these outcomes.~      Obese adults who undergo weight-loss surgery are at risk for bone loss and decreased bone~     strength. The investigators do not know the effects of such surgery on bone in teenagers and~     young adults. The purpose of this study is to find out how different types of weight loss~     surgery affect bone density and strength in teenagers and young adults and compare these~     results to obese teenagers and young adults who are not undergoing weight-loss surgery.~   "
77275|NCT02555527|"~     To perform a cost-effectiveness analysis for the routine use of contrast in rest~     echocardiography in patients with dilated or ischemic cardiomyopathy from the United States~     healthcare system, provider and payer perspectives.~   "
77101|NCT02557802|"~     The investigators will explore in an experimental medicine healthy human model of~     immunisation, whether switching the route of sequential administration of licensed influenza~     vaccines can result in an immune response that is broader in its ability to recognise~     different substrains of influenza viruses. The investigators will do this by initially giving~     an immunisation with a nasal or an injected vaccine, and then switching subjects over to~     receive a second dose one month later (when the cellular component of immunity will have~     matured) via the opposite route (nasal->injected or injected->nasal). The investigators will~     use research assays that can map the different parts of the influenza virus that the~     vaccinated person's immune cells recognise at baseline, after the first immunisation, and~     then again after the second, to see if the breadth of the recognition has broadened to~     include new strains or virus components. Should this pilot study give an indication that the~     breadth has widened (rather than just a further boost to the same responses seen after the~     first immunisation) it will provide justification for a larger study in which statistical~     significance may be powered for observed changes.~      The study is funded by ADITEC, which is a collaborative research programme that aims to~     accelerate the development of novel and powerful immunisation technologies for the next~     generation of human vaccines.~   "
77102|NCT02557789|"~     A Phase 1 study to assess the bioavailability and pharmacokinetics of a 600 mg immediate~     release tablet formulation of lefamulin when administered to fed and fasted healthy subjects~     in comparison to an intravenous formulation and a capsule formulation.~   "
77103|NCT02557776|"~     The overall purpose of the study is to evaluate a method for offering mutation analysis of~     BRCA1 and BRCA2 to all patients with newly diagnosed breast cancer, regardless of age at~     diagnosis and family history. Information about the study as well as pre-test genetic~     counseling will primarily be given in a written way. In addition to that, if a study~     participant wishes to, she can also receive pre-test telephone genetic counseling.~   "
77104|NCT02557763|"~     The aims of this study is to compare the results between patients without severe~     patellofemoral arthritis and patients with severe patellofemoral arthritis after mobile~     bearing UKA.~      The investigators prospective compute the results including anterior knee pain, knee society~     score, pain score, functional score, range of motion, operative time, blood loss, and~     component alignment.~   "
77105|NCT02557750|"~     The aim of this study is to retrospectively investigate the effect of combined modality~     treatment of pediatric hepatoblastoma and the factors affecting the prognosis in accordance~     with the experience at the pediatric oncology department at South Egypt Cancer Institute.~   "
77106|NCT02557737|"~     The aims of this study were to compare the injection locations of key spastic muscles on~     upper extremity by three different guidance localization methods ( surface anatomy landmark,~     ultrasonography, electric stimulation) and the effectiveness.~   "
77107|NCT02557724|"~     To study if the administration of corticoid hinder or enhance the mobilization of Mesenchymal~     Stem Cells (MSCs) in the peripheral blood during liver transplantation and whether this~     affects the outcome with respect to graft versus host response.~   "
77108|NCT02557711|"~     The aim of this study: 1. To evaluate the correlation between the clinic tools and ultrasound~     elastography/ ARFI imaging in stroke patients. 2. To assess the reliability of elastography/~     ARFI imaging in spasticity evaluation of stroke patients.~   "
77109|NCT02557698|"~     Epidermis that lacks moisture and/or sebum presents as dry skin, which is often characterized~     by a pattern of fine lines, scaling and itching. In dry skin, the barrier function may be~     compromised. Skin care practices to decrease the risk of development of dry skin and/or to~     improve dry skin condition have barely been investigated. Bathing with bath oils has been~     shown to increase skin hydration, thus helping to stabilize skin barrier function. Therefore,~     the aim of this study is to investigate the effect of bathing every other day on the skin~     barrier. Functional parameters, such as TEWL, stratum corneum hydration (SCH) and skin-pH~     (pH) were measured to characterize skin barrier function.~   "
77110|NCT02557685|"~     This study aims to document early changes in the distal gut microbiota (both fecal and~     mucosa-associated) post FMT. Furthermore, whole blood and urine samples will facilitate~     collaborative immunologic and metabolomic analyses.~      This will be an open label clinical trial of FMT to prevent further recurrence in patients~     who have suffered at least a third episode of Clostridium difficile infection (CDI) and who~     have previously been treated with oral vancomycin.~   "
77111|NCT02557672|"~     This will be the first prospective randomized controlled clinical trial directly comparing~     Prothrombin Complex Concentrate (PCC) Compared to Fresh Frozen Plasma (FFP) for post~     cardiopulmonary bypass microvascular bleeding and factor-mediated coagulopathy. Is there a~     difference in bleeding and transfusion requirements in patients received PCC versus FFP?~   "
77112|NCT02557659|"~     This extended investigation is to provide continued physician access to the device and~     collect confirmatory safety and effectiveness data.~   "
77113|NCT02557646|"~     The purpose of this open-label, non-randomized, single-arm, multicentre observational study~     is to investigate the influence of the cumulative dose (total administered dose/ planned~     dose) of ribavirin on the sustained virologic response (SVR) in participants who have been~     receiving combination therapy with pegylated interferon alfa-2a (Pegasys) and ribavirin~     (Copegus).~   "
77114|NCT02557633|"~     There is increasing evidence that the effectiveness of allergy immunotherapy to control~     symptoms of rhinoconjunctivitis is related to the cumulative dose of allergen or allergoid~     administered during a single regimen of subcutaneous (SC) injections or of sublingual~     administration.~      Two new cumulative doses of the Grass MATA MPL 10200 and 18200 SU (Standardized Units) are~     being developed to compare with the current dose of 5100 SU. The purpose of this study is to~     evaluate the tolerability and safety of these two new cumulative dose regimens of Grass MATA~     MPL compared with placebo in patients with seasonal allergic rhinoconjunctivitis (SAR) due to~     grass pollen, to enable selection of the best dose to go into a larger scale study to assess~     the efficacy and safety of the higher cumulative doses.~   "
77115|NCT02557620|"~     This trial is conducted in Europe. The aim of this trial is to compare the steady-state~     exposure of semaglutide administered subcutaneously once daily to semaglutide administered~     subcutaneously once weekly in healthy subjects.~   "
77119|NCT02557568|"~     The nasal carriage of Staphylococcus aureus is a major risk factor of S. aureus infection,~     notably in hemodialysis patients (HPs). Decolonization strategies were shown able to reduce~     the rate of S. aureus infection in this category of patients although the risk of emergence~     of antimicrobial resistance persists. Approximately one quarter of the general population is~     colonized by S. aureus in the anterior part of the nostril (vestibulum nasi). Three main~     categories of nasal carriers have been historically identified: persistent carriers (20%,~     12-30%]), intermittent carriers (30%, [16-70%]) and non-carriers (50% [16-69%]). By contrast~     to intermittent carriers and non-carriers, persistent nasal carriers have a higher risk of S.~     aureus infection, especially in continuous peritoneal dialysis and in orthopedic surgery.~      Persistent carriers are characterized by a higher nasal bacterial load, a longer duration of~     carriage, a lower rate of exchange of S. aureus strains, and a particular affinity for the~     carried strain. However, there is no consensual definition of this persistent carriage state.~     In previous studies, 5 to 12 nasal sampling episodes were realized for a period ranging from~     5 weeks to 8 years. The index of carriage, corresponding to the number of samples positive~     for S. aureus divided by the total number of samples, has been proposed to standardize the~     definition of the carriage state. According to standard tools, it is almost impossible to~     determine the nasal carriage state in routine practice.~      Recently, an algorithm based on one or two quantitative cultures from nasal samples taken~     within 2 days that was able to distinguish accurately persistent and non-persistent nasal~     carriers of S. aureus has been described; only one nasal sample was needed in more than 9~     cases out of 10. The aim of the present study was to assess prospectively the reliability of~     this algorithm in clinical practice in a cohort of healthcare workers (HCWs) and HPs and to~     check its ability for identifying patients with the highest risk of S. aureus infection~   "
77120|NCT02557555|"~     The purpose of this study is to learn how the investigators can better educate pregnant~     patients about the options open to them for pain relief during labor. Patients will receive~     educational pamphlet during prenatal clinic visit and again on admission to labor and~     delivery. The options for analgesia will be discussed by anesthesia care provider. Patient~     will be asked to complete a survey on the post partum unit.~   "
77121|NCT02557542|"~     A pilot randomised controlled trial looking at the setting up of a one stop vein clinic for~     the treatment of varicose veins and assessing the quality-adjusted life years at 3 months of~     patients This will be a pilot study which is designed to provide us with enough information~     for a potentially larger multicentre randomised controlled study.~   "
77122|NCT02557529|"~     72 patients with head and neck cancer, undergoing primary treatment with radiation therapy~     and concomitant weekly cisplatin, will be recruited to this multicentre trial.~      Randomized 1:1 to either 12-week progressive resistance training (PRT) program or control~     arm, starting together with concomitant chemoradiotherapy (CCRT) Stratified by centre,~     gender, p16-status and body mass index (BMI) below or above 30.~      Primary endpoint is difference in change in lean body mass (LBM) between the groups and the~     endpoint is reduction of LBM loss in intervention arm by 25% compared to control.~      Secondary endpoints include side-effects to treatment, change in body composition, physical~     function and strength, and compliance to PRT. Questionnaires on QoL, diet, voluntary exercise~     and work affiliation will also be registered.~      Blood samples for explorative analyses will be drawn and optional muscle biopsies drawn for~     proteomics analyses and histological analyses.~   "
77123|NCT02557516|"~     Combination study of IPH2201 with Ibrutinib in relapsed or refractory Chronic Lymphocytic~     Leukemia (CLL) patients in 2 parts :~        -  phase 1b : a 3+3 design to assess the Maximum Tolerated Dose (MTD)~        -  phase 2a: to evaluate the anti-leukemic activity of the combination~   "
77124|NCT02557503|"~     To investigate the therapy effect and security of oxaliplatin and fluorouracil on with or~     without concomitant vascular invasion and extrahepatic metastases unresectable advanced~     primary liver cancer~   "
77125|NCT02557490|"~     The purpose of this study was a randomized controlled trial to compare the effect of~     oxaliplatin and raltitrexed treatment of colorectal cancer with liver metastases by TACE~     hepatic artery infusion~   "
77126|NCT02557477|"~     The primary objective was to assess whether supplementation of Omega 3/6 fatty acids improves~     mainstream schoolchildren's reading ability. The secondary objective was to assess whether~     Omega 3/6 improves cognitive functions such as attention, memory, learning,~     language/communication, problem solving and social ability.This was a 3-month randomised,~     double-blind, placebo-controlled study followed by one-way crossover (placebo to active~     treatment) for an additional 3 months. Mainstream schoolchildren aged 9-10 years were~     initially randomised to receive three Omega 3/6 capsules twice daily or identical placebo.~     All outcome measures were assessed at baseline, 3 months and 6 months. The primary outcome~     measure was the LOGOS test, a comprehensive test battery for evaluating reading abilities.~     Secondary outcome measures were the parent-rated Attention Deficit Hyperactivity Disorder~     (ADHD) Rating Scale-IV, 5-15 scale (domains of learning, memory, language/communication and~     problem solving); Social and Communication Disorders Checklist (to evaluate social ability)~   "
77127|NCT02557464|"~     The objective of this study is to identify early and accurate semantics markers of~     Alzheimer's disease (AD) by using two types of methods. First, the investigator will evaluate~     semantic processing of patients with AD or related disorders which will be compared to age~     matched controls by taking neuropsychological tests. Then, the investigator will analyze the~     effect of contextual word predictability on eye movements in reading sentences with the help~     of the same participants by using an eye tracker. Both of these methods will be used twice~     with a time interval of 6 months.~   "
77128|NCT02557451|"~     AMD is a disease of the central retina, a zone that enables fine detail activities (reading,~     detail…). This central zone of the retina can be affected by a haemorrhagic complication when~     small abnormal vessels suddenly start to bleed inside the retina. Several therapeutic~     approaches are currently available even though they have never been truly compared. The study~     will be proposed to patients who need to be treated for haemorrhage of the macula. A certain~     number of factors will be evaluated to compare the 2 principal approaches currently used in~     France: surgery followed by injections of an anti-angiogenic OR intravitreal injections of~     gas followed by injections of anti-angiogenics. This is a multicentre, randomized controlled~     trial to compare these 2 therapeutic approaches.~      These diametrically opposed approaches have very different consequences for patients and in~     terms of cost for society. The consequences for patients will be immediately measurable so as~     to determine the best therapeutic approach in terms of functional recovery and the impact of~     the disease on quality of life, while taking into account the risks inherent to these 2~     treatments. The impact on quality of life of these 2 approaches as well as their consequences~     - an important factor in this disease, which is a cause of sensory handicap - will provide~     the ophthalmological community with essential information making it possible to validate one~     or the other of these methods for the management of these haematomas.~   "
77130|NCT02557425|"~     Each year, ~85.3 million pregnant women are at risk of becoming infected with Plasmodium~     falciparum(1). Among women in sub-Saharan Africa, most of whom have some degree of clinical~     immunity to malaria, malaria infection in pregnancy leads to placental malaria (PM), often~     without clinical symptoms in the mother. The systemic and placental changes that occur with~     malaria in pregnancy can adversely affect the developing fetal brain, an fetal brain injury~     strongly affects long-term childhood neurodevelopmental (ND) and behavior but there are no~     published studies to date on the impact of malaria in pregnancy on childhood ND. This study,~     conducted in Uganda, will address the effects of malaria in pregnancy and childhood ND and~     define mechanisms by which malaria may lead to ND impairment including micronutrient~     deficiencies. ND outcomes will be measured by the following neuropsychological and behavioral~     tests: Mullen Scales of Early Learning, the Color Object Association Test, the Early~     Childhood Vigilance Test, the Behavior Rating Scales, the Behavior Related inventory of~     Executive Function and the Child Behavior Checklist. These tests will be given at 12, 24 and~     36 months of age. This study will be nested in an ongoing Ugandan IRB approved interventional~     trial (PROMOTE-II) (NCT02163447). Blood sampling is being conducted in the PROMOTE-II~     protocol for research purposes. Some of that blood will be used to test for micronutrient~     deficiencies as well as other immune responses to malaria.~   "
77131|NCT02557412|"~     OBJECTIVES Main objective: To assess if six months of treatment with CPAP, associated with~     conventional treatment, improves the lipid profile of patients with dyslipidemia and~     mild-moderate apnea-hypopnea syndrome (OSA).~      Secondary objectives:~        -  Determine the additional effect of CPAP on insulin resistance and dyslipidemia in~          patients with mild-moderate OSA.~        -  Assess the impact of CPAP treatment in reducing cardiovascular risk in patients with~          dyslipidemia and mild-moderate OSA.~      DESIGN Randomized, parallel group, non-blind, controlled clinical trial with conventional~     treatment.~      STUDY POPULATION 35-75 year old subjects, diagnosed with dyslipidemia in last six months and~     in stable treatment during the last month with diet, cholesterol lowering drug, and~     cholesterol LDL levels> 100 mg / dl in the last two successive visits clinics.~      Sample size. 38 patients who completed the test in each treatment arm.~      TREATMENT~      Patients will be randomized to one of the following treatment arms form:~        1. hygiene and dietary recommendations.~        2. lifestyle intervention (more strict and promotion of daily physical activity and dietary~          control).~        3. Treatment with positive airway pressure (CPAP).~      ENDPOINTS:~      Efficacy endpoints.~        -  Primary endpoint: LDL-cholesterol.~        -  Total cholesterol, HDL-cholesterol, triglycerides and C-reactive protein high~          sensitivity (hsCRP).~        -  Systemic Biomarkers: inflammatory (IL-6, IL-8 and tumor necrosis factor (TNF)-α),~          oxidative stress (8-isoprostane), endothelial damage (endothelin, vascular cell adhesion~          molecule 1 (VCAM-1) and Intercellular Adhesion Molecule 1 (ICAM-1)), sympathetic~          activity (neuropeptide Y) and appetite-regulating hormones (leptin, orexin A /~          hypocretin-1 and ghrelin).~        -  Fasting glucose, glycated hemoglobin (HbA1c), fasting insulin and Homeostasis Model~          Assessment (HOMA) index and quantitative insulin sensitivity check index (QUICKI),~          thyroid-stimulating hormone (TSH).~        -  Clinical questionnaires: short-form (SF)-12, EuroQoL, Functional Outcomes of Sleep~          Questionnaire (FOSQ) and International physical activity questionnaire (IPAQ).~      Security endpoints.~        -  Notification of clinical adverse events.~        -  Compliance with CPAP (average hours use per day).~        -  Epworth Sleepiness Questionnaire.~        -  Development of cardiovascular events.~   "
77132|NCT02557399|"~     This is a multicentre, randomized, single-blind (investigator is blinded), active (the~     combination therapy of adapalene [ADA] and clindamycin [CLDM])-controlled and parallel-group~     study in Japanese subjects with facial acne vulgaris. The purpose of this study is to~     evaluate the efficacy, safety and tolerability of CLDM 1 percent (%)-benzoyl peroxide 3%~     (Duac®: trademark owned by GlaxoSmithKline) once daily fixed dose combination gel versus~     combination therapy of ADA 0.1% gel and CLDM 1% gel in the topical treatment of facial acne~     vulgaris for 12 weeks. A total of 400 subjects will be screened for enrolment. Subjects will~     use Duac® fixed dose combination gel with quantity sufficient to cover entire face (including~     the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) or combination~     therapy of ADA 0.1% gel with quantity sufficient to cover entire face (including the~     forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice~     daily, once in the morning and once in the evening (at bedtime) for 12 weeks.~   "
77133|NCT02557386|"~     To establish adequate volume of levobupivacaine 0.25% in adductor canal nerve block in~     unilateral cruciate ligament of the knee reconstruction surgery.~   "
77134|NCT02557373|"~     The purpose of this study is to assess feasibility of rice bran consumption in weaning~     children and to identify dietary rice bran mediated changes to the stool microbiome and stool~     metabolome.~   "
77135|NCT02557360|"~     Primary biliary cirrhosis (PBC) is a chronic cholestatic liver disorder which may lead to~     several symptoms such as intractable pruritus or chronic fatigue, significantly impairing~     patients quality of life. Recent studies show, that chronic liver diseases are associated~     with an acquired deficiency of S-adenosyl-L-methionine (SAMe) synthetase, responsible for the~     synthesis of SAMe from methionine. SAMe deficiency is associated with impaired detoxification~     and hepatoprotection and exacerbate liver injury. Supplementation with SAMe has proven useful~     in several liver diseases.~      The study group will include 20 patients with PBC diagnosed with European Association for the~     Study of the Liver (EASL) criteria, who have been already treated with ursodeoxycholic acid~     (UDCA). They will receive SAMe in the dose of 1600 mg bd over the period of 6 months. Both~     clinical and laboratory aspects will be analyzed: liver serum biochemistry, serum and urine~     bile acids metabolites, transient elastography and health related quality of life.~   "
77136|NCT02557347|"~     The objective of this study is to determine the effectiveness of treating peritoneal dialysis~     (PD) patients with fluid overload by a structured nurse-lead intervention protocol. We plan~     to recruit 100 PD patients with fluid overload. These patients will be assessed and managed~     by a renal nurse specialist in the ambulatory renal center according to a standardized~     protocol. The improvement in the degree of overhydration will be determined by bioimpedance~     spectroscopy 4 and 12 weeks after treatment.~   "
77137|NCT02557334|"~     The purpose of this study is to evaluate the effects of freeze dried strawberry powder on LDL~     cholesterol, central and peripheral blood pressure, indices of arterial stiffness, and other~     lipid and lipoprotein concentrations. The investigators hypothesize that the bioactive~     compounds in freeze dried strawberry powder may elicit beneficial effects on LDL cholesterol,~     as well as blood pressure and arterial health.~   "
77154|NCT02557113|"~     Leakage of polymethylmethacrylate (PMMA) is the most common complication during vertebral~     body augmentation and can lead to serious patient morbidity. Any measure to reduce the rate~     of cement leakage is of value and makes the procedure safer.The aim of this study was to~     investigate the effect of the creation of a cavity on cement leakage during vertebroplasty.~     Investigators tested the hypothesis that the creation of a merely small and irregular cavity~     in vertebral body prior to cement injection would reduce cement leakage.~   "
77138|NCT02557321|"~     This is an international multicenter, open-label, sequential phase study of intralesional~     (IL) PV-10 in combination with immune checkpoint inhibition. Stage IV metastatic melanoma~     patients with at least one injectable cutaneous or subcutaneous lesion who are candidates for~     pembrolizumab will be eligible for study participation. In the Phase 1b portion of the study,~     all participants will receive the combination of IL PV-10 and pembrolizumab (i.e., PV-10 +~     standard of care). In the subsequent Phase 2 portion of the study participants will be~     randomized 1:1 to receive either the combination of IL PV-10 and pembrolizumab or~     pembrolizumab alone (i.e., PV-10 + standard of care vs. standard of care).~   "
77139|NCT02557308|"~     An Observational, Prospective Cohort Study to Evaluate Safety and Efficacy of RemsimaTM in~     Patients with Ankylosing Spondylitis~   "
77140|NCT02557295|"~     An Observational, Prospective Cohort Study to Evaluate Safety and Efficacy of RemsimaTM in~     Patients with Rheumatoid Arthritis.~   "
77141|NCT02557282|"~     The purpose of this clinical study is to evaluate the CARESTREAM Vue PACS 12.1.5 Computed~     Tomography (CT) Perfusion (investigational device) imaging performance. Evaluation of CT~     Perfusion (CTP) imaging will compare CTP with the predicate device, the Olea Sphere PACS with~     CT Perfusion Module.~   "
77142|NCT02557269|"~     ASIT naïve patients sensitized to grass pollens will be recruited for the study. All of them~     will be instructed to treat bothersome in-season symptoms when they appear (on as needed, pro~     re nata basis) with rescue medication. They will be given 5 different options and will be~     informed about the effects of each of them in order to make their optimal choice for~     different symptoms and their combination: local decongestant (xylomethazoline, when~     congestion is leading), local antihistamine (azelastine, when itching, sneezing and rhinorhea~     a predominant), nasal corticosteroid (momethasone, when all nasal symptoms are pressing and~     no adequate relief is obtained form the other 2 local treatments), oral antihistamine~     (bilastine, when itching and sneezing persist despite the local treatments) and oral~     corticosteroid (prednisolone, when any or all symptoms become unbearable despite the other~     suggested treatments). Patients who are reluctant to use immunotherapy or who are too late to~     initiate it will be randomized to be treated with the listed medications on as needed basis,~     the nasally applied formulations will be followed by either HPMC to prolong and enhance their~     effect (Group HPMC) or placebo (lactose powder) (Group Placebo) to serve as control. Patients~     indicated and willing to carry out ASIT will be treated according to the standard protocol~     with grass allergens sublingually (Staloral #688) and will receive rescue medication (Group~     Immunotherapy).~   "
77143|NCT02557256|"~     The aim of the study is to retrospectively review data about malignancies that arise~     primarily in the pelvis and/or in the pelvic organs, in pediatric cancer patients &~     categorize the spectrum of these malignancies according to experience at South Egypt Cancer~     Institute which is the largest referral site in Upper Egypt.~   "
77144|NCT02557243|"~     The aim of this study is to identify demographic & disease characteristics in pediatric~     oncology patients diagnosed with soft tissue & bone tumors involving the extremities &~     treatment outcomes in these patients.~   "
77145|NCT02557230|"~     The aim of this study is to identify demographic & disease characteristics in pediatric~     oncology patients diagnosed with one of genitourinary tumors & treatment outcomes in these~     patients.~   "
77146|NCT02557217|"~     NP202 is an experimental drug being developed by Armaron Bio Pty Ltd for potential use as a~     treatment for people after they have had a heart attack (MI).~   "
77147|NCT02557204|"~     The primary aim of this study is to investigate the difference in the first attempt and~     overall success rate of different techniques for insertion of nasogastric tube. Secondary aim~     is to investigate the difference of the duration of insertion using the selected technique,~     complications during insertion such as kinking, knotting, mucosal bleeding~   "
77148|NCT02557191|"~     Approximately 2% of neonates in the US are born very preterm. Preterm births are associated~     with impaired cognitive, language and motor function, and increased risk for autism spectrum~     disorders. Epidemiological studies indicate a dose-response relationship between gestational~     age at delivery and cognitive impairments, with the most immature of newborns being the most~     susceptible to developmental delays. Sensitive and reproducible biomarkers of long-term~     neurocognitive impairments are currently lacking. The investigators seek to identify~     epigenetic markers that mediate the relationship between adverse prematurity-related~     exposures and neurocognitive impairments. The overarching hypothesis of this proposal is that~     DNA methylation profiles of CD34+ hematopoetic progenitor and stem cells from very preterm~     infants can be used as a risk-stratifying biomarker for predicting neurocognitive impairment~     in childhood.~   "
77149|NCT02557178|"~     Minnesota HealthSolutions Corporation (MHS) proposes to develop and evaluate a program to~     motivate and monitor people with chronic obstructive pulmonary disease (COPD) to complete~     home exercise as part of pulmonary rehabilitation (PR). The proposed system has two~     components: home-based activity monitoring and health coaching. The investigators will~     conduct a randomized, wait-list controlled clinical study to evaluate the effects of the~     activity monitoring system and health coaching on quality of life and daily steps.~   "
77150|NCT02557165|"~     Muscle weakness and atrophy are important consequences of chronic obstructive pulmonary~     disease (COPD) and can affect both respiratory and peripheral muscles. Impaired muscle~     regeneration is thought to be implicated in the process of muscle atrophy. In this study the~     investigators will evaluate muscle regenerative potential of the Vastus Lateralis (VL) and~     diaphragm of patients with COPD, compared to patients with normal lung function.~   "
77151|NCT02557152|"~     The purpose of this registry is to gain a real world perspective for the use and outcomes~     associated with the Sonendo® GentleWave System usage. The registry population includes up to~     500 subjects that have been treated with the Sonendo GentleWave System at up to 25 clinical~     sites in the United States.~   "
77152|NCT02557139|"~     Bioavailability, Phase I study to evaluate the clinical performance of the tablet formulation~     in the fasted and fed states, in comparison to the capsule formulation in the fed state.~   "
77153|NCT02557126|"~     The purpose of this study is to assess safety, Pharmacokinetics/Pharmacodynamics and Urate~     Lowering Effect of URC102 in gout patients.~   "
77155|NCT02557100|"~     The purpose of this study is to examine changes in immune cells and proteins in response to~     treatment with two approved therapies for Rheumatoid arthritis (RA), abatacept versus~     adalimumab, both given in combination with methotrexate.~   "
77158|NCT02557061|"~     Colorectal cancer (CRC) is one of the most common cancers in France (36,000 new cases / year)~     and nearly 16,000 people die each year from this disease. The lymph node involvement of the~     surgical specimen is today the main tool on which is based the adjuvant treatment decision~     after curative surgical resection. The study of new predictive factors to identify patients~     at risk for developing a local or metastatic recurrence is therefore a major challenge.~      It is now clear that the immune system plays a role in the control of tumor's development,~     and it was shown that there was a correlation between the presence of a CD3+ T-lymphocyte~     infiltrate in colorectal cancers and patient survival. Preliminary studies suggest an~     important role of regulatory T-lymphocyte in the modulation of the antitumor immune response.~     The aim of our study is to follow a cohort of patients operated for colon cancer with~     curative intent to highlight the prognostic characteristics of the tumoral infiltrate by~     various lymphocyte populations (particularly T-lymphocytes but also B-lymphocytes and~     regulatory lymphocytes). It will be performed a preoperative analysis of blood circulating~     lymphocytes with antibodies specific for different cell populations (CD3, CD4, CD8, CD56,~     CD16, CD19, CD2) and stage of activation (CD25, CD69, HLA-DR ) or differentiation (CD24,~     CD38, CD27, CD103, CD62L, CCR7, CD45RA / RO, IgD). The presence of regulatory T-lymphocytes~     will also be analyzed. It will be performed on tumor sample a Tissue Microarrays for~     immunohistochemical study to determine the presence of different lymphocyte populations. We~     systematically study the markers CD68 (monocytes / macrophages), CD56 (NK cells), CD20 and~     CD79a (B cells / plasma cells), CD3 (T cells), CD8 (cytotoxic T), CD4 (helper T) FoxP3~     (regulatory T), cytotoxicity of CD8 markers (Fas ligand, perforin and granzyme) and MHC I~     (antigen presentation) to explore the innate and adaptive immune responses. For each section,~     the different zones will be analyzed (center and invasive margin and healthy tissue). The~     main objective of the study is the influence of the tumor infiltration rate by CD3 + T cells~     on disease free survival at 2-years in patients with non-metastatic colon cancer resection.~     The secondary objective is to search a correlation between the rate of T-lymphocytes on~     preoperative blood sample and on tumor sample.~   "
77159|NCT02557048|"~     The aim of the study is to identify demographic characteristics, various histopathologies,~     and site preferences for each disease entity of malignant head and neck tumors in pediatric~     oncology patients & treatment outcomes in these patients, according to experience at South~     Egypt Cancer Institute which is the largest referral site in Upper Egypt.~   "
77160|NCT02557035|"~     PALO-15-17 is a clinical study assessing efficacy and safety of a single dose of palonosetron~     0.25 mg administered as a 30-minute IV infusion compared to palonosetron 0.25 mg administered~     as a 30-second IV bolus (Aloxi, an antiemetic drug), both given with oral dexamethasone. The~     objective of the study is to demonstrate that infused IV palonosetron 0.25 mg is as effective~     as (non-inferior to) injected palonosetron IV 0.25 mg to prevent nausea and vomiting induced~     by highly emetogenic cancer chemotherapy in the 0-24 hours after administration of a single~     cycle of highly emetogenic chemotherapy~   "
77161|NCT02557022|"~     A low glycemic index (GI) diet has been associated with improved glycemic control in type 2~     diabetes patients and a reduced risk of cardiovascular disease (CVD). Low glycemic load (GL)~     diets have been associated in cohort studies with a reduction in both diabetes incidence and~     CVD events, especially in overweight individuals, and have been recommended by the Canadian,~     American and European diabetes associations. Life style modification trials have shown that~     reducing body weight in overweight or obese individuals improves obesity-related risk~     factors. The process of a systematic review combines the results from many studies in order~     to arrive at a pooled weighted average of the true effect. The investigators propose to~     conduct a systematic review and meta-analysis of the highest quality evidence from randomized~     controlled trials to assess the effect of low GI/GL diets on body weight change. The results~     of this synthesis will inform clinical practice guidelines and lead to better health outcomes~     through informing healthcare providers and patients, stimulating industry innovation, and~     guiding future research.~   "
77162|NCT02557009|"~     The study is designed as a prospective observational study. Each participant will have their~     BP, CVP, PAP, and CO measured by their clinical nurse using indwelling catheters placed for~     routine patient monitoring. Measurements will be recorded on an hourly basis during the day~     and for as many days as possible if the required measurements are being made for clinical~     care.~      Sixty patients between 18 and 85 years of age will be recruited in HVICU by means of~     convenience sampling. Data will be analyzed using a test of equivalence on the initial~     measurements (test of equivalence between two means) and then over time (repeated~     measurements) with a linear mixed-effects model.~   "
77163|NCT02556996|"~     This is a randomized, double-blind, placebo-controlled clinical trial performed in Egyptian~     children 6-18 months of age. The primary aim of the study is to determine the protective~     efficacy of an oral, inactivated whole-cell enterotoxigenic Escherichia coli (ETEC) vaccine~     against diarrhea associated with excretion of ETEC that express a vaccine-shared antigen over~     a one year period of follow-up by active surveillance. The vaccine consists of a mixture of~     five formalin-killed ETEC bacteria expressing prevalent ETEC colonization factors and~     recombinant cholera toxin B-subunit (killed ETEC/rCTB vaccine). The placebo preparation is~     heat-killed Escherichia coli K-12 bacteria.~   "
77164|NCT02556983|"~     The study will explore CT radiation dose as low as reasonably achievable in diagnosing acute~     appendicitis, by using of dose simulation technique and iterative reconstruction.~   "
77165|NCT02556970|"~     This study seeks to establish if thoracoscopic surgery performed through a single port or~     incision reduces early post-operative pain compared with conventional multiple port~     thoracoscopic surgery.~      This initial pilot study is designed to establish whether a trial of the two techniques is~     acceptable to patients, clinically feasible and can be delivered in a reasonable timescale.~   "
77166|NCT02556957|"~     Kasensero, a fishing community on Lake Victoria in Uganda, is a representative HIV hotspot~     with extremely high HIV prevalence (44.3%) and incidence (~3.9/100py), yet low HIV service~     utilization. Hotspots such as Kasensero may seed and sustain HIV in general populations,~     compromising national and regional HIV control efforts. PEPFAR, UNAIDS, and WHO have~     recognized the urgent need to target hotspots with enhanced HIV treatment and prevention~     efforts. However, evidence on low-cost, comprehensive, and effective HIV control strategies~     for hotspots is limited and is thus a priority need for the field.~      The investigators propose an implementation science, cluster-randomized, controlled trial in~     Kasensero to evaluate the impact on HIV service uptake and HIV incidence of CHWs promoting~     combination HIV prevention (CHP) services supported by mobile health technologies (mHealth).~     CHP is the implementation of multiple, evidence-based HIV prevention services (HIV testing~     and counseling, antiretroviral therapy, medical male circumcision, and behavior change) to~     maximize population-level impact on HIV incidence. For CHP to substantively decrease HIV~     incidence, most community members must be assessed for risk factors and current CHP~     utilization, then triaged, motivated, linked, and, if HIV-infected, retained in care. The~     proposed intervention will use low-cost CHWs leveraging mHealth decision support and~     counseling tools to promote CHP along this entire continuum of HIV service utilization. The~     hypotheses for this implementation science research are that residents in clusters receiving~     the implementation intervention will have improved CHP service uptake and decreased~     Population Prevalence of Viremia (PPDV) compared to controls receiving standard of care.~      The intervention will be evaluated through a pragmatic, cluster-randomized trial nested~     within a large, ongoing population-based cohort study of HIV, the Rakai Community Cohort~     Study (RCCS). Intervention arm participants will be visited in their place of residence by~     CHWs trained to evaluate and triage participants into risk categories, provide tailored CHP~     health counseling, linkage, and adherence support, all supported by a mHealth decision~     support tool. The primary outcomes will be CHP service coverage and PPDV. Other outcomes will~     be HIV incidence, population viral load, implementation measures, retention, virologic~     suppression, and sexual behaviors.~      Complimentary mixed methods (quantitative, qualitative, and cost) evaluations of the trial~     will be conducted to evaluate implementation processes, facilitators, and barriers to inform~     study results and future program uptake. Focus groups and in-depth interviews will be~     conducted during and after the follow-up period and synthesized with quantitative data.~     Intervention costs will be prospectively measured to provide information on program~     affordability.~      Through this study, a novel, low-cost, and scalable implementation intervention to improve~     CHP uptake will be evaluated in an HIV hotspot critical to controlling the HIV epidemic.~     The study design ensures rigorous evidence of immediate relevance to many stakeholders.~   "
77167|NCT02556944|"~     To assess postsurgical visual acuity (distant, intermediate, near), refractive errors,~     contrast sensitivity, visual function and patient satisfaction after implantation of~     multifocal IOLs of different add power contralaterally.~   "
77168|NCT02556931|"~     To see if it is possible to use short-duration tacrolimus after a peripheral blood stem cell~     transplant in certain malignancies that are considered difficult to engraft.~   "
77169|NCT02556918|"~     The purpose of this study is to determine whether treatment with sitagliptin reduces the~     frequency and severity of high blood sugar (hyperglycemia) after cardiac surgery and to~     determine whether treatment with sitagliptin is effective in maintaining blood sugar control~     in patients with type 2 diabetes (T2D).~   "
77184|NCT02556723|"~     Diabetic macular edema (DME), wet-AMD and macular edema secondary to vein occlusions are the~     leading cause of blindness in developed countries. Several therapies have been studied as~     such laser treatment and intravitreal injections of corticosteroids or anti-VEGF drugs. In~     terms of public health the long term treatment with the current available drugs is very~     expensive and new therapies with the same or better effect should be investigated. This study~     intends to evaluate the efficacy and safety of intravitreal injections of ziv-aflibercept for~     the treatment of patients with DME, wet-AMD and macular edema secondary to vein occlusions.~   "
77170|NCT02556905|"~     The main purpose of REVLIMID® DUE (Drug Use Examination) is to collect and evaluate the~     safety information of Korean Multiple Myeloma patients treated with REVLIMID® according to~     the approved package insert, after approval of marketing authorization for new drug in Korea.~     In addition, the efficacy information of REVLIMID® in clinical practice is collected and~     evaluated. This DUE is a multi-centre, observational and non-interventional post-marketing~     surveillance.~      The patients can be recruited through both Drug Use Examination after the initiation of Post~     Marketing Surveillance(contract with institution) and Patient Access Program(PAP) that was~     performed before REVLIMID® reimbursement.~      Total 624 patient has enrolled in PMS by 07Sep2016. Validation process for eligibility for~     safety assessment has been conducted by site monitoring process by 07Dec2016.~      REVLIMID® DUE is to investigate frequency and change of Adverse Events(AEs) /Adverse Drug~     Reactions(ADRs), Serious Adverse Events(SAEs)/Serious Adverse Drug Reactions(SADRs),~     unexpected AE/ADR and unexpected SAE/SADR, and to scrutinize factors influencing safety &~     efficacy of the drug.~      It is necessary to examine patients' demographics and baseline characteristics, medical~     history, status of REVLIMID® treatment, concomitant medication and evaluation of safety and~     final efficacy (best response) assessment.~   "
77171|NCT02556892|"~     The purpose of this study is to evaluate the safety of Ibrutinib in Japanese participants~     with treatment-naive chronic lymphocytic leukemia ( CLL) or small lymphocytic lymphoma (SLL).~   "
77172|NCT02556879|"~     Anti HLA alloimmunization against the donor evaluated by the detection of anti-donor specific~     antibodies (DSA) is an underestimated factor in liver transplantation and may contribute to~     dysfunction and graft loss , especially among candidates for retransplantation, that have~     major immunization.~      This study will analyzed immunization markers at the time of liver retransplantation and~     systematically in patients follow-up. This will allow to characterize the histological~     lesions due to humoral immunization, to establish further investigations and to adapt early~     immunosuppressive therapy.~   "
77173|NCT02556866|"~     Multicenter randomized double-blind study comparing the efficacy and safety of rituximab in~     combination with corticosteroids to corticosteroids plus placebo in the treatment of~     non-infectious active mixed cryoglobulinemia vasculitis.~   "
77174|NCT02556853|"~     The patients will be allocated to 2 groups: the ultrasound group and the clinical group. The~     correct position of the double lumen tube will be determined by ultrasound (Sonoscape S6®)~     for the patients of the one group (group U) and by clinical examination for the patients of~     the other group (group C). The correct placement will be verified by bronchoscopy (Pentax®).~     The two methods will be compared in terms of sensitivity and specificity. The main purpose of~     the study is to determine if the ultrasound can be used for determination of the correct~     placement of the left sided double lumen endotracheal tube~   "
77175|NCT02556840|"~     Maturity-onset diabetes of youth (MODY) are the most frequent monogenic diabetes with~     autosomic dominant inheritance (2% of diabetes). The MODY2 diabetes is related to a defect in~     the glucokinase (GCK) enzyme, the first limiting step of insulin secretion. An abnormal GCK~     leads to a delayed insulin secretion. Patients with GCK mutations have only mild raised~     fasting plasma glucose. Treatment is usually unnecessary since hyperglycemia is stable and~     MODY2 patients have no microvascular complications of diabetes. In contrast, pregnancy in~     MODY2 women is a challenging situation. A non-mutated fetus will produce excess insulin in~     response to raised maternal blood glucose leading to an accelerated growth and a higher risk~     of macrosomia. The mother of non-mutated fetus should therefore be treated to normalize her~     blood glucose levels. On contrary, a mutated fetus will produce a delayed insulin secretion~     (as his MODY2 mother) in response to maternal hyperglycemia. Consequently insulin therapy~     during pregnancy would reduce fetal insulin secretion and result in a low birth weight.~      Moreover, insulin therapy exposes pregnant women to more labor induction, prematurity and~     cesarean deliveries. In these MODY2 women whose glucose set point is physiologically higher,~     glycemic goals are difficult to achieve while often requiring extensive insulin therapy. An~     optimal situation would consist in initiating insulin therapy only for women with non-mutated~     offsprings. Unfortunately no antenatal diagnosis of the GCK mutation on fetal cells is~     available yet. In literature, birth weight differences between mutated and non-mutated~     neonates may reach up to 700g. In clinical practice, two strategies are used but without~     standardized protocol on glycemic targets, delay and doses of insulin : 1) insulin at~     diagnosis of pregnancy 2) treatment based on fetal abdominal circumference and fetal weight~     measurements by ultrasonography (US) and initiated if fetal biometry is greater than the 75th~     percentile.~      The purpose of the study is to evaluate for the first time these two management strategies~     through a prospective and standardized study. Hypothesis: US assessment would be sufficient~     to identify fetuses at risk of macrosomia and to initiate insulin treatment in mothers.~   "
77176|NCT02556827|"~     Aim of study is to determine reactive oxygen products and antioxidant capacity with rosacea~     patients; to measure metalloproteinase level and inflammatory markers of immune response and~     investigate their corelation with demodex infestation and also investigate the role of~     photoaging and sebum secretion in rosacea.~   "
77177|NCT02556814|"~     The project was undertaking by Qilu Hospital of Shandong University in China. In order to~     report the efficacy and safety of caffeic acid tablets combining with high-dose dexamethasone~     for the treatment of adults with newly-diagnosed primary immune thrombocytopenia (ITP).~   "
77178|NCT02556801|"~     The purpose of this study is to assess safety, tolerability and demonstrate a dose response~     signal using Total Symptom Score (TSS), based on challenges with grass pollen in an~     Environmental Exposure Chamber (EEC), followed by estimation of the minimum effective dose of~     SUBLIVAC FIX Phleum (SP) after 10 months of treatment compared to placebo.~      The study has 4 treatment groups: 3 different doses of SP and placebo will be tested.~   "
77179|NCT02556788|"~     Assessment of the efficacy and safety of CD5789 50µg/g cream applied once daily for 12 weeks~     in subjects with acne vulgaris.~   "
77180|NCT02556775|"~     The purpose of this registry is to acquire safety data (including assessment of anti-rHuPH20~     antibodies), regarding the course and outcome of pregnancy in women ever treated with HYQVIA.~     Development of the fetus/infant at birth and for the first 2 years will also be followed.~   "
77181|NCT02556762|"~     This randomized phase III trial is to compare simultaneous modulated accelerated boost with~     standard dose radiotherapy given together with chemotherapy in treating patients with~     esophageal squamous cell carcinoma.~   "
77182|NCT02556749|"~     The purpose of this study is to evaluate the effects of cranberry juice on central and~     peripheral blood pressure, indices of arterial stiffness, lipid and lipoprotein~     concentrations and size characteristics, and HDL function. The investigators hypothesize that~     the bioactive compounds in cranberry juice may elicit beneficial effects on blood pressure~     and arterial health, as well as LDL-C and HDL function.~   "
77183|NCT02556736|"~     RST-001 is a gene therapy given as an injection into the eye.~   "
77185|NCT02556710|"~     This study will evaluate the efficacy and safety of an intra-articular injection of AMPION™~     in adults with pain due to osteoarthritis of the knee~   "
77186|NCT02556697|"~     Systemic sclerosis (SSc) is a generalized disorder of connective tissue, arterioles and~     microvessels, characterized by the occurrence of fibrosis and vascular obliteration~     phenomena. The alterations in lung microvessels are found in pulmonary involvement of~     scleroderma, which are the most serious complications of the disease.~      In pulmonary emphysema, there are also changes in pulmonary microvasculature, which are~     involved in the onset and development of the disease.~      The confocal endomicroscopy is an endoscopic technique which can be performed during a~     bronchoscopy. This technique makes it possible to observe in real time the most distal~     pulmonary elements at the microscopic scale. After injection of fluorescein, then the~     technique of observing the pulmonary microvasculature, in vivo and in situ.~      The characterization of microvascular lesions in these two pathologies could improve~     understanding of their mechanisms and ultimately improve the early management of patients.~   "
77187|NCT02556684|"~     A prospective cohort study design will be conducted. Patients with LABC who receive~     chemotherapy will undergo physical examination, ultrasound, MRI, and BSGI at baseline,~     midway, and at the completion of chemotherapy. Approximately 100 patients will be recruited~     over a 2-year period. This study will give clinicians further insight into the usefulness of~     ultrasound, MRI, and BSGI in monitoring treatment responses in patients with LABC. This could~     potentially lead to changes in clinical management of these patients.~   "
77188|NCT02556671|"~     Dual antiplatelet therapy (DAPT) with standard doses of aspirin and clopidogrel has long been~     the cornerstone in patients undergoing percutaneous coronary intervention (PCI). However,~     inhibition of platelet activation and aggregation after DAPT varies greatly among patients.~     Some clinical studies have demonstrated that patients with high on-treatment platelet~     reactivity are at increased risk of major adverse cardiovascular events. Tailored~     antiplatelet therapy seems offer an opportunity to improve outcomes after coronary stenting~     by drug adjustment based on platelet function testing. Unfortunately, the results of 3 major~     prospective trials (GRAVITAS, ARCTIC, TRIGGER PCI) of personalized antiplatelet therapy are~     neutral. In these studies, platelet function was only assessed by a single measurement and a~     single method early after the start of antiplatelet treatment. To test the stability of~     platelet reactivity measurements over time among patients undergoing PCI, investigators use 3~     methods (VerifyNow P2Y12 assay, Flow cytometric assessment of the phosphorylation status of~     VASP, light transmittance aggregometry) for platelet function testing in 2 periods (~14days),~     with maintenance doses of clopidogrel.~   "
77189|NCT02556658|"~     The purpose of this study is to evaluate if prediction of general anaesthesia level by the~     Smartpilot® View device can improve the quality of anaesthesia in patients undergoing hip~     fracture surgery.~   "
77190|NCT02556645|"~     The purpose of this randomized controlled trial is to compare the efficacy and potential~     biological mechanisms of action of 10 sessions of a web-version of Prolonged Exposure (PE),~     Web-PE, delivered over 8-weeks to 10 sessions of Present Centered Treatment (PCT) delivered~     over 8-weeks by a therapist in 120 active duty military personnel with PTSD. Up to 170~     individuals will be consented to obtain data from 120 for analysis. Participants will be~     assessed at pre-treatment, mid-treatment, and 1-, 3- and 6-months after treatment completion.~   "
77191|NCT02556632|"~     This randomized pilot phase II trial studies and compares prophylactic topical agents in~     reducing radiation-induced dermatitis in patients with non-inflammatory breast cancer or~     breast cancer in situ. The prophylactic topical agents, such as curcumin-based gel or HPR~     Plus, may reduce the severity of the radiation-induced dermatitis by minimizing water loss~     and inflammation during radiation therapy.~   "
77192|NCT02556619|"~     The purpose of this research study is to evaluate the effect of early palliative care~     consultation on quality of life, use of hospital resources, end-of-life care and survival~     among Hepatocellular Carcinoma (HCC) patients with advanced End Stage Live Disease not~     eligible for potentially curative or local area therapy. Half of patients will receive early~     palliative care at diagnosis of HCC and other half will receive palliative care when all~     standard therapy treatments have been exhausted.~   "
77193|NCT02556606|"~     The purpose of this study is to examine the effectiveness of a single infusion of ketamine~     (KET), to determine which dose is optimal and lasts the longest, and to learn about how~     ketamine works in the body and brain in persons with late-life treatment resistant~     depression.~   "
77194|NCT02556593|"~     This study is to assess the efficacy of IMRT combined with erlotinib compared with~     whole-brain radiotherapy for EGFR wild type non-small cell lung cancer with 4-10 brain~     metastases.~   "
77195|NCT02556580|"~     The study aims to determine the degree of plasma volume expansion and the half-life of the~     plasma volume expansion when 3 mL/kg of hyperoncotic (20%) albumin if infused over 30 minutes~     in conscious healthy volunteers, in patients undergoing surgery under general anesthesia, and~     on the day after major surgery when the patient is in a post surgical inflammatory state. The~     study also examines the increase in the plasma colloid osmotic pressure as a result of this~     infusion and its possible influence on markers of kidney damage.~   "
77196|NCT02556567|"~     This is a research study to find associations between asthma symptoms and sleep patterns and~     physical activity among adolescent patients with persistent asthma. The Investigators will~     collect Fitbit® sensor data and survey data from each adolescent enrolled in the study.~   "
77197|NCT02556554|"~     A single-center, prospective, 'open-label,' investigator-initiated pilot study evaluating the~     role of continuous glucose monitor (CGM) use either alone or with remote monitoring~     capabilities during pregnancy associated with T1DM.~   "
77198|NCT02556541|"~     The purpose of this investigation is to conduct a randomized, patient-blinded prospective~     controlled trial comparing peripheral intravenous cannulation in children done by:~        1. Conventional landmark cannulation where the intravenous cannulation is done by direct~          visual guidance or palpation or a combination thereof.~        2. Ultrasound guided cannulation by means of DNTP.~      The investigators hypothesize that with ultrasound-guided peripheral intravenous cannulation~     the first-attempt success rate will be significantly higher than by the conventional landmark~     cannulation technique.~   "
77209|NCT02556398|"~     The project involve evaluation of a web-based nutrition education program and pilot-testing~     of a new smartphone app for real-time data logging to identify factors causing glycemic~     variability.~   "
77199|NCT02556528|"~     This is a study to assess the feasibility of using health coaching sessions in cancer~     patients. The investigators are investigating whether health coaching sessions can be~     delivered to this group of participants in a semi structured way. The investigators hope that~     the study will allow us to see whether such sessions can be delivered in a timely manner that~     is acceptable to patients and staff. The longer term aim for this work, should it prove~     feasible, is to conduct a randomised controlled trial to assess health coaching.~      The participants for the study will be selected using purposive sampling. The investigators~     will select a sample of 10 patients. The participants will be patients at the Oxford~     University Hospitals NHS Trust who are prescribed oral anticancer therapy. The sample will~     include male and female patients and try to cover a range of ages from 18 upwards. It will~     cover patients taking a range of oral anticancer agents, for a range of different cancer~     indications. The sample will look at patients who are newly prescribed oral anticancer~     therapy through to patients who have been taking therapy for years.~      Participants will be identified for the study by multidisciplinary staff members who are~     running oral education sessions or by non-medical prescribers who are seeing patients in~     clinic. These members of the MDT will be given lists of the types of participants the~     investigators are looking for in the study and where appropriate offer patients the~     opportunity to take part. Patients will be contacted prior to the end of their subsequent~     cycle of treatment about whether they wish to participate. Patients wishing to take part will~     be consented at their next clinic visit.~      All participants will attend for their usual clinic visits throughout the study. Participants~     will additionally be offered up to 3 health coaching sessions for a maximum of three cycles~     or until treatment with their oral anticancer agent ends, whichever comes first.~      At the end of study visit participants will be asked to attend a qualitative based interview~     to discuss the intervention.~   "
77200|NCT02556515|"~     Interpositional arthroplasty is by many considered to be the current gold standard for the~     treatment of thumb carpometacarpal arthritis. The results are generally good, but the~     rehabilitation time can be long and failures are difficult to treat. Total joint replacements~     now exist with modern uncemented designs that can be an alternative treatment. Short term~     studies show that thumb function often is better and rehabilitation time shorter, however~     there is uncertainty with regards to the longevity of the implants. Currently no prospective~     randomized trials have compared these two treatment options. Our hypothesis is that the total~     joint replacement will give the same results or better when compared to the interpositional~     arthroplasty.~   "
77201|NCT02556502|"~     The diagnosis of Alzheimer's disease (AD) is based on clinical and neuropathological~     criteria.~      Some patients have a contributive CSF biology to determinate a high level risk of AD (Tau +~     phospho-tau ratio increased and Ab42 / decreased Aβ40), but others have an intermediate CSF~     biology (Tau and/or phospho-tau increased but Ab42 ratio / normal Aβ40) and are~     unclassifiable.~      18F-Florbetaben (Neuraceq®), a radioisotope in positron emission tomography (PET),~     selectively binds to amyloid plaques, with high detection sensitivity (98%).~      Detection of amyloid plaques by PET imaging separate patients according to the criteria of~     Dubois, as with AD and allow them to benefit a cholinesterase inhibitor treatment.~      If negative, the diagnosis of AD can be excluded with a high level of confidence to prevent~     initiating unnecessary treatment, expensive for the community.~      This is the first imaging study of amyloid plaques targeting population whose diagnosis of AD~     is uncertain according to the CSF biology.~      The aim of this study is to describe the results of amyloid PET in case of intermediate CSF~     biology and to separate patients as AD or not according to the criteria of Dubois~   "
77202|NCT02556489|"~     Analyse the transcriptomic signature of anti vaccinia memory B cells at a short time after~     vaccination as compared to the signature already established in long-lived memory B cells.~   "
77203|NCT02556476|"~     The purpose of this study was to examine the cost effectiveness of critical care in a middle~     income country with limited resources.~      The main study hypothesis was that critical care is cost effective in low resources setting.~   "
77204|NCT02556463|"~     To evaluate MEDI9197 when administered by intratumoral injection to subjects with solid~     tumors or CTCL, and in combination with durvalumab and/or palliative radiation in subjects~     with solid tumors.~   "
77205|NCT02556450|"~     Despite advances in care, prognosis remains poor once overt Heart Failure (HF) has developed.~     Prevention is most efficient when directed toward patients at risk and when mechanistically~     targeted to patients most likely to respond. An increase in myocardial and possibly vascular~     collagen content (fibrosis) may be a major determinant of the transition to HF. In patients~     with hypertension and diabetes, two important risk-factors for HF, changes in blood markers~     of fibrosis occur before clinically overt HF develops. These markers are also related to~     prognosis.~      In the general population, Galectin-3 (Gal-3), a potential marker of fibrosis, is associated~     with cardiovascular (CV) risk factors, and predicts development of HF. In animal models,~     Gal-3 is a key mediator of aldosterone-induced CV and renal fibrosis and dysfunction.~      The investigators hypothesize that the mineralocorticoid receptor antagonist (MRA),~     spironolactone, may prevent HF by acting on extracellular matrix remodelling, especially in~     patients with active fibrogenesis, identified by high Gal-3 levels. The benefit/risk ratio of~     spironolactone might be superior in patients with a higher compared to lower plasma~     concentrations of Gal-3.~      Main objective is to investigate whether spironolactone can favourably alter extra-cellular~     matrix remodelling, assessed by changes in the fibrosis biomarker Procollagen Type III~     N-Terminal Peptide (PIIINP), in patients at increased risk of developing heart failure and~     whether this effect is greater in patients with increased plasma concentrations of Gal-3.~   "
77206|NCT02556437|"~     The purpose of this study is to evaluate the efficacy and safety of HyQvia (Immunoglobulin~     10% with recombinant hyaluronidase) with conventional subcutaneous immunoglobulin treatment~     in patients with Multifocal Motor Neuropathy (MMN).~   "
77207|NCT02556424|"~     Corticosteroids, whether injected peri- or intra-ocularly, remain indispensable tools of the~     therapeutic arsenal in treating inflammatory macular edema. However, a few years ago, only~     triamcinolone acetonide was available to ophthalmologists. This molecule, developed initially~     for rheumatological or dermatological use, has been increasingly deployed in ophthalmology,~     while still off-label.~      In 2011, the delivery system of dexamethasone from biodegradable and injectable implant into~     the vitreous cavity obtained the label for inflammatory macular edema. This protocol is~     therefore designed to compare the efficacy and safety of peri- and intra-ocular injections of~     corticosteroids in the treatment of inflammatory macular edema.~   "
77208|NCT02556411|"~     Adenomyosis is characterized by the appearance of endometrial cells in the muscular layer of~     the uterus. It affects about 15-20% of the female population.~      The symptoms of adenomyosis are heavy menstrual bleedings and painful menstruation~     (dysmenorrhea) and in addition chronic pelvic pain. Regarding treatment~     levonogestrel-releasing intrauterine system, Gonadotropin releasing hormone (GnRH)-analogues,~     Danazol, uterine embolization and endometrial ablation have been tried. The aim of this study~     is to compare the efficacy and usefulness of association of oral contraceptive pill and~     LNG-IUS or LNG-IUS alone~   "
77212|NCT02556359|"~     The molecular mechanisms participating in the various aspects of the DNA Damage Response~     (DDR) are absolutely essential to maintain the genome dynamics essential to all living~     organisms. The most commonly studied consequence of faulty DDR is genome instability~     participating in cancer onset. In the present proposal, we wish to explore another aspect of~     DDR, not relevant to cancer, which is its absolute requirement at several key steps of the~     development, maturation, and function of the immune system.~      The most spectacular consequences of faulty DNA repair processes with respect to the~     immuno-hematopoietic tissue are the complete block of B and T lymphocytes maturation owing to~     defective DNA joining phase during V(D)J recombination resulting in patients with Severe~     Combined Immune Deficiency (SCID).~      The objectives of this study are to increase our knowledge on the role of the various DNA~     repair processes in the development, the maintenance, and the function of the immune system~     and thus, to better understand why and how dysfunctions of these DNA repair processes result~     in human severe conditions such as CVID, LOCID or other manifestations of immune disorders~     such as autoimmunity.~      The explorations of DNA repair mechanisms in the patients will allow us to establish the~     genetic diagnosis in some patients with until now undefined molecular diagnosis. This is of~     immediate importance for the patients and their families, as it not only contributes to a~     better understanding of the patients' condition, but also allows providing genetic counseling~     for the families.~   "
77213|NCT02556346|"~     This Phase I, multiple ascending dose study will seek to enroll subjects with~     relapsed/refractory Chronic B-cell Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma~     (SLL) with confirmed and measurable disease who have received standard treatment with at~     least one anti-CD20 antibody (e.g.; rituximab, ofatumumab) containing front-line regimen that~     resulted in initial response, followed by relapse/recurrence and who are not eligible for any~     further approved biologic therapy, chemotherapy and/or autologous stem transplantation and/or~     refuse alternative approved therapies and/or are unlikely to achieve clinical benefit from~     any therapy of higher priority by Investigator assessment.~   "
77214|NCT02556333|"~     Background:~      HIV attacks the immune system. Antiretroviral therapy (ART) is a combination of drugs used~     for treating HIV infection. For some people, ART drugs stop working against their HIV.~     Researchers want to see if a different form of the drug tenofovir (an ART drug currently~     approved by the FDA), combined with another drug, may help people whose HIV is resistant to~     ART. This combination pill is called F/TAF~      Objective:~      To study the safety and efficacy of the drug F/TAF, when used with other ART, for people~     whose HIV infection has been hard to control with available medicines.~      Eligibility:~      People age 14 years and older who have HIV infection and are enrolled in the DOTCOM~     (14-I-0009) protocol.~      Design:~      Participants will be screened with physical exam, medical history, and blood and urine tests.~      Participants will stay in the hospital for at least 10 days. For the first 9 days, they will~     take F/TAF by mouth along with their usual ART drugs.~      In the hospital, they will repeat the screening tests.~      Participants will have a DEXA scan, an x-ray that measures calcium and other minerals in the~     bones. Participants will lie on a soft table while the scanner passes over the lower spine~     and hips.~      Participants will get a supply of F/TAF and some new ART drugs to take at home.~      Participants will have follow-up visits in 1, 2, 4, 8, and 12 weeks. After the 12-week visit,~     they will come back about every 3 months for about 1 year.~      At these visits, participants will repeat the screening tests. They will discuss any problems~     taking their ART drugs. They may have another DEXA scan.~   "
77215|NCT02556320|"~     A recent study has shown that certain drug allergies were actually related to an immune~     system against certain viruses. The aim of the study is to evaluate, in patients taking~     antiepileptic drugs, if this treatment induces proliferation of these viruses and secondarily~     an immune response that would promote the development of a rash. In particular, will be~     studied whether these drugs can induce virus reactivation dormant in the immune system.~     This study will not affect the usual follow-up proposed by investigators, with the exception~     of some additional blood samples.~   "
77216|NCT02556307|"~     In this Slovenian, multi-center, observational study, the effectiveness of standard of care~     Peginterferon alfa-2a + ribavirin treatment in adult patients with chronic hepatitis C (CHC)~     is examined. Patients were treated for 24- or 48-weeks, as prescribed by the treating~     physician, followed by a 24-week follow-up period.~   "
77217|NCT02556294|"~     India has the world's third largest HIV epidemic and men who have sex with men (MSM) are an~     identified high risk group. MSM in India face unique psychosocial stress underlying the~     context of HIV risk. To maximize the potential impact of an HIV prevention intervention, the~     purpose of this study is to test, in a two-arm randomized controlled efficacy trial, a~     behavioral intervention that addresses both psychosocial / contextual stress and reducing~     participant's risk for HIV.~   "
77218|NCT02556281|"~     After curative surgical resection, detection of metastatic lymph node remains the main~     prognostic validated criteria on which is based the decision of adjuvant therapy. To date,~     none of the molecular alterations, identified as potentially predictive factor, are used in~     routine for therapeutic decision. The circulating markers, either in the form of free~     circulating DNA or in the form of circulating tumoral cells seems important potential~     candidates. To investigators knowledge, only one study estimated with several interesting~     results the prognostic interest of a coupled detection of the free circulating mutant DNA~     (gene KRAS) and by the hypermethylation of the p16 gene. Definitive conclusions remain~     however difficult to achieve because of the small number of patient included (n=58) and the~     fact that this study included different stages. For colorectal cancer a Chinese team~     presented a series of results suggesting that the presence of CTC during the postoperative~     course is a factor significantly related to the risk of recurrence. In multivariate analysis~     integrating the lymph node status and the vascular invasion, the presence of CTC appeared as~     an independent factor for recurrence with a hazard ratio of 29.5.~      The aim of the present study is to compare the prognostic value of two circulating tumoral~     markers KRAS point mutations and RASSF2A methylation (free tumoral DNA) and Circulating~     tumoral cells (CTC). The primary objective is to compare sensibility and specificity of two~     circulating markers (free tumoral DNA and tumoral cells) on 2 years disease free survival~     rate. Secondary objective is to confirm the prognostic value of circulating free tumoral DNA~     and circulating tumoral cells in localised colorectal cancer.~   "
77219|NCT02556268|"~     To investigate the pharmacokinetic drug-drug interaction potential of fixed dose~     antiretroviral therapies, i.e. ATRIPLA, COMPLERA, STRIBILD, TRIUMEQ, or any approved~     antiretroviral protease inhibitor in combination with (preferably) TRIUMEQ, on the exposure~     to riociguat in HIV patients on a stable dose of one of these therapies.~      • To Assess the safety and tolerability of riociguat treatment in combination with these~     fixed-dose antiretroviral therapies.~   "
77220|NCT02556255|"~     The aim of the study is to assess the safety and efficacy of the use of the Eximo's CathiTM~     hybrid catheter in subjects affected with Peripheral Artery Disease (PAD) in lower extremity~     arteries.~   "
77221|NCT02556242|"~     Since 2000, annual numbers of malaria cases in South Africa have sharply declined to about~     5,000, with case numbers fairly stable since 2007. The principal malaria prevention strategy~     has consisted of generalised Indoor Residual Spraying (IRS) of all houses in malaria endemic~     districts. As recent case data indicate that the levels of transmission in many districts~     have been reduced to very low levels, the continuation of untargeted IRS in areas where there~     is little or no evidence of recent transmission may be unwarranted. Efforts to eliminate~     malaria will only be sustainable if mass prevention efforts can be scaled down in an~     evidence-based manner, whilst maintaining or enhancing high sensitivity of the surveillance~     system of the disease. This trial will provide scientific evidence for targeted malaria~     prevention responding to localised transmission in pre-elimination settings, compared to~     continuation of generalised IRS of all houses.~      Two methods of IRS delivery for community malaria prevention will be compared through an~     open-label cluster-randomised trial consisting of two study arms with 30 clusters per arm of~     approximately 8,000 inhabitants per cluster.~      Comparison is on the basis of non-inferiority by showing that malaria incidence in the~     targeted IRS arm is no higher than malaria incidence in the generalised IRS arm within a~     specified margin of difference, and on the basis of superiority showing that the proportion~     of houses targeted for spraying is higher in the intervention than the reference arm.~     Neighbourhood investigation in response to two cases in the intervention arm, and comparison~     neighbourhoods in the reference arm, will include testing for antibody sero-conversion to~     malarial antigens to assess whether cases arise in communities with long term exposure to~     malaria parasites.~      The trial will be carried out in the South African provinces of Limpopo and Mpumalanga, in~     localities which have average reported incidence of malaria of <5 cases per 1000 per annum~     over the past five years.~   "
77222|NCT02556229|"~     Inflammatory choroidal neovascularization (InCNV) is the third cause of CNV after myopia and~     Age-related Macular Degeneration (AMD). InCNV is a rare but severe disease and its treatment~     should not be delayed.~      InCNV is treated at the moment with off-label anti-VEGF (Vascular Endothelial Growth Factor)~     therapy and could also benefit from aflibercept (EYLEA), a new anti-VEGF currently indicated~     in AMD. Case reports suggest that such patients would not need as many injections as in AMD.~      ALINEA is an open-label, single arm, prospective, multicenter, phase II study. The main~     objective is to demonstrate the effectiveness in clinical terms after 52 weeks of treatment~     with aflibercept on the visual acuity of patients affected by InCNV. A specific dosage~     regimen is designed to achieve maximum efficiency. The patients are followed on a monthly~     basis until 52 weeks. The first injection is mandatory. The other ones are injected only in~     case of active InCNV.~   "
77223|NCT02556216|"~     Bone and mineral disease is a key problem in patients with kidney disease. The available~     clinical parameters are non-specific, unproven for the assessment of the bone metabolism and~     do not reflect the complexity and diversity of the underlying bone pathology. The aim of this~     study is to use bone histology, novel bone markers and bone imaging results to establish a~     reliable decision model (diagnostic tool) that can be used to guide the individual therapy.~   "
77224|NCT02556203|"~     To assess whether a rivaroxaban-based anticoagulation strategy, following successful TAVR,~     compared to an antiplatelet-based strategy, is superior in reducing death or first~     thromboembolic events (DTE).~      To assess the primary bleeding events (PBE) of the rivaroxaban-based strategy compared to an~     antiplateletbased strategy, following TAVR.~   "
77225|NCT02556190|"~     The emergence of multidrug-resistant bacteria has recently renewed interest in colistin. Data~     on dosing in critically ill patients undergoing extended dialysis are missing. The aim of~     this study is to determine the pharmacokinetics of colistin during extended dialysis in~     critically ill patients and to provide dosing guidelines for this drug.~   "
77226|NCT02556177|"~     This is an open-label, non-randomized, prospective, multi-site, parallel group (segment),~     hypothesis-generating study designed to collect data that will aid in future scientific and~     engineering exploration of correlations between clinical neuropsychological assessments and~     GE Research Pack II advanced MR imaging in mTBI patients. The results are primarily intended~     for scientific inquiry and engineering development purposes, and may be used in future~     regulatory submissions.~   "
77227|NCT02556164|"~     Gait and balance disorders, key contributors to fall and poor quality of life, represent a~     major therapeutic challenge in Parkinson's disease (PD). Despite the widespread use of~     acupuncture in recent years in PD, its efficacy remains unclear, largely due to~     methodological flaws and lack of high quality studies using objective outcome measures. In a~     patient and assessor-blind pilot study, investigators objectively assess the efficacy of~     electroacupuncture (EA) for gait and balance disorders using body-worn sensor technology in~     patients with PD.~   "
77228|NCT02556151|"~     Fecal Incontinence (FI) affects 8-15 % of the US population, predominantly women and elderly,~     and 45% of nursing home residents. It significantly impairs quality of life and poses a major~     health care burden. FI is characterized by significant neuromuscular dysfunction of the~     pelvic floor that includes bilateral lumbo-anorectal and sacro-anorectal neuropathy and~     sensori-motor dysfunction. This multifactorial etiology suggests that maladaptive~     neuroplastic changes in the neural innervation of lower gastrointestinal tract could play a~     significant role in the pathogenesis of FI. A critical barrier to progress in the treatment~     of FI is the lack of understanding of how treatments affect the core pathophysiological~     mechanisms of FI, and the absence of mechanistically based non-invasive therapies. Our goal~     is to address the problem of FI by developing therapies that modulate peripheral and central~     neuronal perturbations and thereby improve visceromotor control and sensori-motor~     dysfunctions, and to understand the neurobiologic basis of these treatments. Our central~     hypothesis is that a novel non-invasive treatment consisting of repetitive translumbar~     magnetic stimulation (rTLMS) and repetitive transsacral magnetic stimulation (rTSMS) will~     significantly improve FI by enhancing peripheral and central neural excitability and will~     provide a multidimensional therapeutic benefit- enhance anal muscle strength, improve stool~     perception and improve rectal capacity. Our approach is based on our preliminary studies~     which suggest that repetitive translumbar magnetic stimulation (rTLMS) and transsacral~     magnetic stimulation (rTSMS) improve anorectal pain and neuropathy and induce central~     neuroplastic changes.~      Our objectives are to:~        1. address the significant gap in our knowledge regarding the peripheral and central~          neuroenteric axis and how perturbations in the afferent and efferent neural signaling~          can affect FI;~        2. develop a new treatment for FI with repetitive magnetic stimulation and determine the~          feasibility, safety and optimal frequency setting of rTLMS and rTSMS;~        3. determine the mechanistic basis for this neuromodulation therapy;~        4. identify if the locus for improvement lies in the afferent or efferent signaling or~          both.~   "
77229|NCT02556138|"~     The purpose of this study is to determine whether the Orbera Intragastric Balloon is a safe~     and effective means for weight loss and improved metabolic disease in patients with cirrhosis~     requiring liver transplantation.~   "
77900|NCT02547350|"~     The purpose of this study is to evaluate the efficacy of prophylactic intravesical~     chemotherapy (different chemotherapy drugs and dosage regimen) in the prevention of bladder~     recurrence after nephroureterectomy for upper tract urothelial carcinoma (UTUC).~   "
77230|NCT02556125|"~     Respiratory dysfunction is the leading cause of death in individuals with spinal cord~     injuries (SCIs). Nearly one quarter of all SCI cases involve injury to the upper spinal cord~     segments which impairs neural activation of the diaphragm muscle and compromises breathing.~     Although mechanical ventilation can be life-saving after cervical SCI (C-SCI), it also~     triggers rapid and profound diaphragm muscle atrophy, thereby complicating (or even~     preventing) ventilator weaning. Intramuscular diaphragm stimulation, or diaphragm pacing, was~     developed to replace long-term ventilator support, and is now used acutely post C-SCI (<4~     months following injury) to promote ventilator weaning. The impact of diaphragm pacing on~     respiratory function and diaphragm muscle activation has not been formally evaluated. This is~     an essential step in determining the efficacy of intramuscular diaphragm stimulation and its~     effects on respiratory function after SCI. Accordingly, this research study will evaluate the~     effects of intramuscular diaphragm stimulation and test the hypothesis that diaphragm pacing~     enhances neuromuscular diaphragm activation and respiratory function in adults with cervical~     SCIs. The investigators will test the hypothesis by evaluating the effects of diaphragm~     pacing on neuromuscular activation of the diaphragm by directly recording electromyogram~     (EMG) activity from the intramuscular pacing electrodes. Recording from these~     surgically-implanted electrodes allows direct comparisons of EMG activity across time,~     minimizing methodological limitations inherent with surface or percutaneous EMG recordings.~     This approach, in association with respiratory assessments, will be used to investigate the~     impact of diaphragm pacing in adults with intramuscular diaphragm pacing electrodes following~     acute, traumatic C-SCIs.~   "
77231|NCT02556112|"~     With this study researchers will evaluate the effects of the GLB intervention on weight loss,~     chronic disease indicators and self-perceived function and well-being in an active duty~     population. The purpose of this study is to examine the effectiveness of the GLB program~     [compared with two currently available programs, the Fitness Improvement Program (FIP) and~     the Better Body Better Life (BBBL) program], on the following health indicators: improvement~     of individual physical fitness as measured by change in abdominal circumference, weight and~     physical activity; decrease in risk associated with chronic disease as measured by changes in~     lipid and HbA1c levels; and improvement in self-perceived function and well-being as measured~     by the RAND 36 Item Short Form Health Survey (RAND SF- 36). In addition, the researchers seek~     to obtain feedback about the programs from the participants.~   "
77232|NCT02556099|"~     The primary goal of the Phase II EXTEND trial is to investigate the effects of open-label~     hydroxyurea treatment, escalated to maximum tolerated dose, for children with Sickle Cell~     Anemia and either conditional (170 - 199 cm/sec) or abnormal (≥200 cm/sec) Transcranial~     Doppler velocities. The primary endpoint will be measured after 18 months of hydroxyurea but~     treatment will continue until a common study termination date.~   "
77233|NCT02556086|"~     The purpose of the study is to determine if combination therapy with daclatasvir (DCV) and~     sofosbuvir (SOF) for 8 weeks is safe and effective in patients who have never been treated~     previously without liver cirrhosis who are chronically infected with hepatitis C virus~     (HCV)/HIV-1 Coinfection genotype (GT) 1, 2, 3, 4 patients.~   "
77234|NCT02556073|"~     Poor adherence to asthma controller medication may link to poor asthma outcome. A metered~     dose device with built-in dose counter helps physicians to monitor drug compliance in asthma~     patients. Mobile-phone based self management opens a window for better asthma control. The~     present study aims to investigate the relationship between the adherence to controller~     medication of combined inhaled corticosteroid/long acting beta2-agonists, assessing by~     integrated dose counter, and the level of airway inflammation and asthma control. Moreover,~     the investigators also use a new asthma self-management Apps to enhance drug compliance. With~     the application of the new, easily available tools, the investigator expect to increase~     adherence rates, and hence, to reduce airway inflammation and improve the level of asthma~     control.~   "
77235|NCT02556060|"~     The purpose of this study is to investigate the efficacy of lamotrigine in the treatment of~     ketamine dependence in a double-blind, placebo controlled design.~   "
77236|NCT02556047|"~     Several vaccinations are administered by the intradermal (ID) method where the vaccine is~     injected between layers of skin. The current technique required to do this can be difficult~     to learn and perform accurately, is slower to deliver than subcutaneous or intramuscular~     injections, and there is a risk that the injection will be given to too-deep skin layers or~     to underlying tissues, which might change the immune response. There is increasing interest~     in using ID administration for vaccines as it may be possible to achieve the same immune~     response with a smaller dose of vaccine. This could increase access to vaccines that are~     expensive or are only available in small quantities and therefore could have global health~     benefit for vaccine programs for diseases such as yellow fever and polio.~      Because of the potential global-health benefits of being able to give ID injections of~     vaccines easily, quickly and with relatively little training or experience, several novel~     devices are currently being developed to allow easy ID administration. Star Syringe have~     developed two novel intradermal safety devices that differ only in the length of the needle~     used. The current study will assess how the two new devices perform, compared to the~     traditional Mantoux test, using injections of saline into the upper arm. Twenty volunteers~     (18-60 years, male and female) will be recruited and attend a screening visit (1), an~     injection visit (2a) and have a follow up telephone call (2b). At the injection visit they~     will receive 3 injections in each arm (Mantoux and 2 device injections) and measurements will~     be performed.~      A subset of volunteers will be invited back to attend an additional visit (3a) which will be~     a repeat of visit 2 but with an ultrasound image taken of each injection site. There will be~     a follow up telephone call 24 hours later (3b).~   "
77237|NCT02556034|"~     This study will establish a comparison in follow-up care of 100 patients between Health Care~     Practitioners, more specifically the rheumatologist and a trained nurse. The study objective~     is to show consistency of evaluation between two different health care professionals, a~     physician and a nurse.~   "
77238|NCT02556021|"~     The purpose of this study is to demonstrate the superiority of efficacy of CJ-12420, once~     daily (QD), compared to placebo in patients with non-erosive reflux disease at Week 4~   "
77239|NCT02556008|"~     This is an open-label observational study of pure CBD for the treatment for 25 children with~     intractable epilepsy. As pure CBD is not FDA approved, the investigators are conducting this~     study via the FDA expanded access mechanism on a compassionate use basis. The target patient~     population is children with severe refractory epilepsy who have exhausted all other~     reasonable avenues of treatment. These are patients for whom the risks of a relatively~     untested product are outweighed by the potential benefit. Using seizure-diaries maintained on~     a routine clinical basis, seizure frequency will be assessed four weeks prior to initiation~     of CBD, one month after CBD initiation, and at least every 3 months thereafter. CBD will be~     administered as an adjunct to all current anti-epileptic therapies.~   "
77240|NCT02555995|"~     Optical Coherence Tomography (OCT) is an established non-invasive medical imaging technique~     ophthalmologists use to diagnose and monitor retinal diseases such as age-related macular~     degeneration (AMD).~      This study assesses the scanning performance of a newly developed sparse OCT retina scanner~     that is smaller and more compact than most commercially available medical OCT systems. The~     prototype device was developed at Artorg Center Bern and Berner Fachhochschule Biel.~      In this study the device is first tested on human eyes. The scanning performance is compared~     to a reference device. Additionally patient feedback during the examination is acquired.~      The findings of this study are used to improve the software and the ergonomics of the~     investigational device.~   "
77241|NCT02555982|"~     Essential head tremor (HT) does not usually respond to drug treatment such as propranolol or~     primidone or to surgical treatment such as deep brain stimulation of the thalamic ventralis~     intermedius nucleus. Botulinum toxin (Btx) is widely used and efficient in the treatment of~     blepharospasm and cervical dystonia. Btx prevents the release of acetylcholine in synapses,~     leading to a reduction of pathological muscle movement. Very little information is available~     on its efficacy on HT. Two published reports suggested that local Btx A injections could be~     an effective and safe approach for treating HT. Given the scarcity of published data (small~     samples, open studies, different doses of Btx used, heterogeneous populations, several~     muscles injected, etc.), the aim of this study is to demonstrate the efficacy of Btx~     injections in essential HT by a multi-center, randomized, double-blind, parallel-group,~     placebo-controlled study.~      Principal objective: To evaluate the efficacy of botulinum toxin injections in the treatment~     of head tremor.~      Secondary objectives:~        -  - To evaluate the tolerance of botulinum toxin injections in the treatment of head~          tremor.~        -  - To evaluate the impact of botulinum toxin injections on the patients' quality of life~          and embarrassment.~        -  To evaluate the changes of tremor characteristics induced by a Btx treatment using a 3D~          accelerometer wireless portable system (Xsens MTw wireless motion tracker system)~          (tremor frequency, tremor displacement, mean peak amplitude, distance traveled) and a~          new video system device to analyze head tremor characteristics~   "
77242|NCT02555969|"~     This protocol will assess patients with AL amyloidosis who achieve a complete response (CR)~     or very good partial response (VGPR) to therapy for minimal residual disease (MRD). Three~     approaches to MRD testing will be used since there is no established method. The~     investigators will clone and sequence each patient's light chain (LC) gene and design~     patient-specific primers to evaluate genomic DNA from future marrow specimens. Whole genome~     sequencing (WGS) will be used to test baseline and follow-up marrow cell DNA, seeking copy~     number variations in chromosomes 1 and 2 or 22, and structural variations in chromosomes 11~     and 14, consistent with the known genetic abnormalities in AL and with clonal LC gene use.~     Plasma protein analysis by mass spectrometry will also be used to look for fragmentary~     protein sequences associated with the culprit LC gene of each subject. The feasibility and~     predictive value of these three approaches in patients achieving CR or VGPR will be~     evaluated. This protocol will help provide insight into the ways that the disease changes and~     progresses. MRD testing is likely an important next step in AL management.~   "
77243|NCT02555956|"~     Diabetic related complications are increasing day by day due to increse in the number of~     diabetic patients all over the world. Diabetic macular edema is one of them and a major cause~     of vision imparment. Various kind of treatment modalities are preent to treat this~     coplication. Grid laser is one treatment modality. Laser phtocoagulation is a destrictive~     procedure.Laser power if kept to aminimum can get the desired results without severe~     destruction to the retina . In this study, the investigators are going to document the effect~     of minimal grid laser tn loss o overcome the visioe to diabetic macular edema.~   "
77244|NCT02555943|"~     This is a prospective study to determine the incidence, morbidity, mortality and predisposing~     factors for the reactivation of hepatitis B virus replication during direct anti-HCV~     treatment of HCV/HBV co-infection patients.~   "
77245|NCT02555930|"~     HIV associated sensory neuropathy (HIV-SN) is a frequent complication of HIV infection,~     affecting between 20 and 57% of infected individuals. The advent of better antiretroviral~     treatment for HIV has meant that mortality from HIV has decreased dramatically in the UK.~     This means however, that chronic, age-related conditions associated with HIV, such as HIV-SN~     and cognitive impairment, are increasing in prevalence and becoming a significant disease~     burden.~      The classification, diagnosis and treatment of HIV-SN remains poor. Currently, little is~     known about the genetic basis of the disorder and what risk factors mean that some patients~     with HIV develop neuropathy and pain, whilst others do not. It is hoped that by further~     characterising or 'phenotyping' the disorder, it will be easier to identify which patients~     are at risk of developing neuropathy and chronic pain. It may also mean that treatment can be~     more individualised as currently patients often undergo a frustrating 'trial and error'~     protocol of treatment, as clinicians can not yet predict who will respond to which treatment.~      It has also been suggested that there is a link between HIV-SN and HIV associated~     neurocognitive disorder (HAND), which is another common, age-related complication of HIV~     infection. It may be that the existence of one pathology could predict the development of the~     other, or that the presence of HAND may impair the diagnosis or treatment of chronic pain~     associated with HIV-SN.~      This study aims to recruit a cohort of HIV patients with and without HIV-SN and to identify~     genetic risk factors for the development of HIV-SN and neuropathic pain. It also aims to more~     deeply phenotype the condition, using well validated questionnaires, and to identify any~     influence that early neurocognitive dysfunction may have on the reporting, diagnosis and~     treatment of neuropathic pain in the HIV population.~   "
77246|NCT02555917|"~     Anterior cruciate ligament injury is very common knee injury. Especially Anterior cruciate~     ligament complete rupture leads to knee joint instability and degenerative change of the~     knee. Anterior cruciate ligament reconstruction is performed for resolving these problems and~     it gives excellent results. For leading to successful result of anterior cruciate ligament~     reconstruction, selecting of appropriate femoral tunnel and tibial tunnel is necessary. If~     selecting inappropriate tibial tunnel location makes pain, synovitis, impingement of~     transplanted tendon, loss of range of motion, instability, failure of transplantation and~     risk of arthritis. It is known that selection of inappropriate tibial tunnel location is the~     most common cause of anterior cruciate ligament reconstruction failure.~      Recently many studies reconstructed at anatomical lesion instead of isometric point. And some~     cadaver studies reported that tibial insertion of anterior cruciate ligament has C shape.~     There are two methods for anterior cruciate ligament reconstruction. One is preserving~     remnant and the other is removing remnant.~      This study aims to compare the tibia and femoral tunnel location of remnant preserving and~     remnant resecting anterior cruciate ligament reconstruction.~   "
77302|NCT02555163|"~     Randomized clinical trial aiming to assess Holmium Laser En Bloc Resection Of Bladder Tumor~     (HoLERBT) in comparison with Conventional Transurethral Resection Of Bladder Tumors (cTURBT)~     in tumor histopathological staging quality, detrusor muscle sampling in biopsy, completeness~     of tumor resection and peri procedure complication.~   "
77247|NCT02555904|"~     This is an observational, single center study to evaluate if acoustic and accelerometer-based~     measures of voice and speech have sufficient precision to detect a change in lung fluid~     status for patients with confirmed acute heart failure syndrome with pulmonary congestion.~     The study shall be conducted in concordance with the United States FDA regulations for a~     non-significant risk study. Patients admitted for acute heart failure syndrome with pulmonary~     congestion with an expected stay greater than 3 to 4 days, who are willing and able to sign~     an informed consent, and who meet all inclusion/exclusion criteria, as identified by the~     clinical investigator, will be enrolled in the study. Results of this study will evaluate the~     sensitivity of voice and speech measures in detecting changes in lung fluid status in a~     symptomatic population. Up to 12 subjects will be enrolled to comparatively evaluate the~     voice outcome measures in this pilot study.~   "
77248|NCT02555891|"~     The overall objective of the present study will be to describe the occurrence of Potentially~     Inappropriate Prescribing (PIP) in Ontario's elderly (>65 yrs) population, assess the health~     and economic burden associated with it, and evaluate interventions aimed at mitigating its~     effects.~      To attain this objective, the investigators will test three specific hypotheses:~      Hypothesis 1: Instances of Potentially Inappropriate Prescribing are frequent and costly. To~     test this hypothesis, the investigators will apply a subset of the STOPP criteria and Beers~     criteria to Ontario health administrative data to identify instances of potentially~     inappropriate prescribing, and estimate potential savings, both direct and indirect, that~     could be achieved by reducing inappropriate prescribing.~      Hypothesis 2: ED visits and hospitalizations are significantly associated with Potentially~     Inappropriate Prescribing. To test this hypothesis, the investigators will estimate the~     attributable fraction of ER visits and hospitalizations associated with different frequencies~     of PIP using multivariate methods and survival analysis.~      Hypothesis 3: The likelihood of inappropriate prescribing is associated with patient and~     physician characteristics. To test this hypothesis, the investigators will identify each~     physician's annual PIP incidence density, calculated by dividing the number of PIP they~     issued by the total number of prescriptions they provided over the study period and then~     explore the association of patient and physician level covariates with patient outcomes.~      The investigators will test these hypotheses in the framework of a retrospective cohort study~     which the investigators will conduct using Ontario's large health administrative and~     population databases. These are housed at the Institute for Clinical Evaluative Sciences~     (ICES) and contain information on both hospital and outpatient use of health services, as~     well as demographic and socioeconomic data. Patients included in the study will be all OHIP~     (Ontario Health Insurance Plan) eligible patients aged 66 yrs of age and older who have been~     issued at least one prescription between April 1st 2003 and March 31st 2013.~      The investigator team, housed at ICES@uOttawa, has extensive experience and expertise with~     the analysis of these databases, and has the support and resources necessary to successfully~     carry out this study.~   "
77249|NCT02555878|"~     The purpose of this study is to demonstrate that rivaroxaban is superior to placebo for~     reducing the risk of the primary composite outcome as defined by objectively confirmed~     symptomatic lower extremity proximal deep vein thrombosis (DVT), asymptomatic lower extremity~     proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT,~     symptomatic non-fatal pulmonary embolism (PE), incidental PE, and venous thromboembolism~     (VTE)-related death in ambulatory adult participants with various cancer types receiving~     systemic cancer therapy who are at high risk of developing a VTE.~   "
77250|NCT02555865|"~     This multicenter retrospective observation study is designed to investigate the etiology of~     children with bronchiectasis by review the medical records.~   "
77251|NCT02555852|"~     The purpose of the study is to determine whether proton pump inhibitors (PPIs), a medication~     used to treat gastric conditions, increase the risk of hospitalization for community-acquired~     pneumonia (HCAP).~      The investigators will carry out separate population-based cohort studies using~     administrative health databases in eight jurisdictions in Canada, the US, and the UK. Cohort~     entry will be defined by the initiation of an oral non-steroidal anti-inflammatory drug, with~     follow-up until hospitalization for pneumonia or end of follow-up (6 months). The results~     from the separate sites will be combined using a statistical approach called meta-analysis to~     provide an overall assessment of the risk of HCAP with PPIs.~   "
77252|NCT02555839|"~     There is a high unmet medical need for an anti-myeloma therapy for RRMM patients previously~     treated with Lenalidomide and Bortezomib, due to poor prognosis.~      This observational study focuses on the collection of data concerning the safe and optimal~     usage of Pomalidomide, a new therapy option for RRMM patients, thereby increasing the~     knowledge about optimal AE management. Beside this, further analysis of tolerability, dosage~     and efficacy will be performed.~      This knowledge could lead to a optimization of Pomalidomide usage and treatment.~   "
77253|NCT02555813|"~     This observational program collects data on tolerability, safety and efficacy regarding the~     use of Abraxane in metastatic pancreatic cancer patients in the daily clinical routine.~     Additionally data on dosage that is actually used in these patients will be collected.~     Patients who have pancreatic cancer and additional diseases can be documented in this study,~     too. Collected data might generate learnings on the optimal use of Abraxane in the daily~     routine setting.~   "
77254|NCT02555800|"~     The aim of this study is to compare the efficacy of intralesional bevacizumab, a monoclonal~     antibody against vascular endothelial growth factor, versus the antiviral drug cidofovir in~     patients with recurrent respiratory papillomatosis.~   "
77255|NCT02555787|"~     A study to evaluate changes over time in renal function from baseline (time of conversion) up~     until five years post conversion in kidney transplant patients converted from tacrolimus~     twice daily (BD) formulations to a once daily formulation as Advagraf.~   "
77256|NCT02555774|"~     This study evaluates the efficacy of cognitive training in subjects with subjective memory~     impairment. The first group will receive cognitive training and lifestyle modification in~     combination, the second group will receive only lifestyle modification, and the third group~     will receive no intervention.~   "
77257|NCT02555761|"~     This post-marketing surveillance study will assess the safety and efficacy of Lastacaft®~     Opthalmic Solution 0.25% (Alcaftadine) for the prevention of itching associated with Allergic~     Conjunctivitis as prescribed as standard of care in clinical practice in Korea.~   "
77258|NCT02555748|"~     This pilot study is an open-label interventional study, prospective, non-comparative,~     sequential (two stages), national, multicenter study.~      Patients starting therapy with sunitinib or pazopanib as standard first line treatment for~     advanced or metastatic renal cell carcinoma will enter the study in one of the two cohorts~     (115 patients will be treated by sunitinib and 99 patients will be treated by pazopanib).~      The purpose of this study is to examine the feasibility of sunitinib and pazopanib dose~     individualisation based on therapeutic drug monitoring (TDM) and to assess the benefit of~     this approach in terms of tolerance and efficacy compared with the current empirical method~     based only on tolerance observation.~   "
77303|NCT02555150|"~     The purpose of this randomized, double-blind, crossover study is to compare two long-acting~     stimulant formulations—once-daily PRC-063 and once-daily lisdexamfetamine (LDX)—through a~     15-hour period on driving performance, as measured with a driving simulator, in adult~     patients with ADHD.~   "
77259|NCT02555735|"~     This is an observational study enrolling patients with metastatic pancreatic cancer to~     identify genomic differences between exceptional responder and non-responders to standard of~     care chemotherapy. Data analysis of the gene expression profile of the exceptional responders~     compared to non-responders will define genomic patterns that may help understand their~     response to chemotherapy.~   "
77260|NCT02555722|"~     This study is a masked, multi-center, daily wear, monthly replacement, bilateral, randomized,~     lens blocked (subjects remain in the same lens brand throughout the study) concurrent control~     study enrolling up to 90 subjects with a study duration of approximately three months.~     Subjects will be randomized into the study contact lenses in a two to one (2:1) ratio of~     fanfilcon A lens (test) to enfilcon A lens (control).~   "
77261|NCT02555709|"~     This is a two-part, randomized, double-blind, placebo-controlled study in which VTP-43742~     will be administered to normal healthy volunteers (NHV) and to moderate to severe psoriatic~     patients, both in sequential ascending dose panels.~   "
77262|NCT02555696|"~     This observational project is collecting tolerability, safety and efficacy data with the~     routine use of Abraxane in the treatment of metastatic breast cancer. Additionally data on~     the dosage of Abraxane and general data on the disease and the health status of the patient~     will be collected.~   "
77263|NCT02555683|"~     This study aims to determine the efficacy and safety of QAW039 (Dose 1 and Dose 2), compared~     with placebo, when added to GINA steps 4 and 5 standard-of- care (SoC) asthma therapy (GINA~     2015) in each of the groups (patients with severe asthma and high eosinophil counts and all~     patients with severe asthma).~   "
77264|NCT02555670|"~     Aim of the present study is to determine whether muscle mass as assessed by bioelectrical~     impedance analysis correlates with and corresponds to muscle mass as assessed by CT scan~     analysis in critically patients admitted to the intensive care unit.~   "
77265|NCT02555657|"~     In this study, participants with metastatic triple negative breast cancer (mTNBC) will be~     randomly assigned to receive either single agent pembrolizumab or single agent chemotherapy~     chosen by the treating physician (TPC) in accordance with local regulations and guidelines,~     consisting of either capecitabine, eribulin, gemcitabine, or vinorelbine. The primary study~     hypothesis is that pembrolizumab extends progression free and/or overall survival compared to~     TPC~   "
77266|NCT02555644|"~     The main purpose of this study is to investigate the safety of prexasertib in combination~     with other anti-cancer drugs (cisplatin or cetuximab) and radiation therapy in participants~     with locally advanced head and neck cancer. The study has two parts (A and B). Participants~     will only enroll in one part.~   "
77267|NCT02555631|"~     The purpose of this two-year proposal is to:~        1. develop and~        2. complete a pilot test of an adaptation of the evidence-based National Diabetes~          Prevention Program (NDPP) tailored to engage men with prediabetes in disadvantaged~          communities in New York City.~      The sites for this pilot study are New York City Parks and recreation centers. Study's main~     outcome is weight loss of 5-7% baseline weight.~   "
77268|NCT02555618|"~     The purpose of this study is to evaluate the immunogenicity and safety of TAK-850~     administered subcutaneously as a single dose versus influenza HA vaccination in an~     exploratory manner.~   "
77269|NCT02555605|"~     This study aimed to determine the feasibility of dexmedetomidine in children with respiratory~     morbidities who required deep sedation for magnetic resonance imaging (MRI) scans.~   "
77270|NCT02555592|"~     The purpose of this study is to identify the treatment outcomes of surgical resection with~     sequential adjuvant chemotherapy and radiotherapy in patients with stage IIIA non-small cell~     lung cancer and N2 disease at only the sub- or para-aortic level.~   "
77271|NCT02555579|"~     This is a study to determine if a simplified protein counting system, including the free~     usage of fruits and vegetables low in phenylalanine, will improve the metabolic control in~     teens and adults with phenylketonuria (PKU).~      Anybody with a positive diagnosis of PKU, between the ages of 13-65 years will be invited to~     participate in this study.~      Subjects will be educated on the simplified system upon enrollment, and historical~     phenylalanine (Phe) levels will be used for comparison. Subjects will also be asked about~     their attitudes towards their current Phe counting system.~   "
77272|NCT02555566|"~     Endothelial lesions within the transplanted kidney are a major determinant of chronic~     allograft nephropathy. Epoxyeicosatrienoic acids (EETs) are endothelium-derived~     hyperpolarizing factors with anti-inflammatory, antiproliferative and vasodilator properties.~      The main goal of the investigators' study is to evaluate whether genetic polymorphisms of~     specific enzymes responsible for the bioavailability of EETs are associated with~     post-transplant kidney function.~      To this end, 80 kidney transplant recipients will be included. Prespecified genetic~     polymorphisms of CYP 2J2, CYP 2C8, CYP 2C9, CYP 2C9, CYP 2C19 and EPHX2 will be determined.~     Kidney function will be recorded 3, 6, 12 and 36 months after transplantation. Flow-mediated~     dilatation, EETs and circulating biomarkers of endothelial function will be measured in the~     radial artery.~      The expected results of this study to provide preliminary evidence supporting a beneficial~     role of an increase in the bioavailability of EETs in kidney transplant recipients.~   "
77273|NCT02555553|"~     The purpose of the proposed Phase II STTR study is to test the primary efficacy of a novel~     mobile app, 'Noom Monitor,' in a large population of binge eaters in the Kaiser Permanente~     health care system relative to a well-established treatment as usual (TAU) control condition.~     Noom Monitor facilitates the delivery of CBT-GSH by utilizing a patient interface that~     increases adherence and provides between-session reminders of CBT-GSH principles. In~     addition, the Noom Monitor includes a therapist interface with weekly feedback to the~     provider about patient progress. This application has several primary objectives, including:~     (1) testing the real-world effectiveness of the Noom Monitor in a clinical setting, and (2)~     establishing a database of training materials for Noom Monitor. The knowledge gained from the~     current study will contribute to our understanding of the role of new emerging mobile~     technologies in augmenting existing treatments.~   "
77274|NCT02555540|"~     The purpose of this protocol is to generate a set of data that will be analysed by integrated~     systems biology approach, for validation in subsequent clinical trials or in animal models.~      240 healthy participants (18-45y) will be enrolled, 200 will be administered a dose of~     Boostrix on Day 0, 20 will receive a placebo on Day 0.~   "
77276|NCT02555514|"~     The association between varus malalignment and dynamic knee loading / adduction moment and~     progression of knee joint cartilage degeneration in the lateral compartment is unclear and~     has not been studied in detail before. There is a need to identify relevant parameters~     explaining this cause-effect relationship. It is the purpose of the study to correlate load~     changes in knee joints with biomechanical and biochemical alterations in cartilage to~     understand the underlying mechanism of load induced cartilage degeneration in patients. This~     study will therefore include patients with different stages of knee OA with various~     malalignments. Moreover, analyzing changes in cartilage morphology, radiography and MRI and~     correlate those findings with alterations in biochemical parameters in cartilage, serum,~     urine and synovial fluid will allow us to identify novel biomarkers for the onset and~     progression of joint cartilage degeneration in varus malaligned knees.~      The following hypotheses will be tested:~        1. Knee joint cartilage degeneration progresses from medial to lateral in varus-aligned~          knees.~        2. External knee adduction moments in patients with isolated medial OA are higher when~          compared with patients with OA of the medial and lateral compartment.~        3. Morphological and mechanical properties of cartilage show different stages of~          degeneration when comparing the mechanically stronger loaded medial with the lateral~          compartment of the knee.~        4. Histological and biochemical analysis of the cartilage indicate different stages of~          degeneration when comparing the mechanically loaded medial with the lesser loaded~          lateral compartment of the knee.~        5. Synovial fluid analysis, as well as serum biomarkers of cartilage metabolism demonstrate~          cartilage degeneration and are related to biomechanical determinants of OA in the knee.~        6. Novel biomarkers (ECM, miRNA, cytokines, mitochondria related, mechanical determinants)~          for varus-aligned knees can be identified.~   "
77277|NCT02555501|"~     The aim of the study was to evaluate the therapeutic action through the diameter of the~     lesion, of low level laser (LLL) associated to photodynamic therapy (PDT) in oral mucositis~     (OM) lesions, in young patients. A randomized clinical trial blinded, split-mouth was~     performed. The study sample consisted of 15 cancer patients (3-16 years old) of Aldenora~     Bello Hospital (São Luís, Maranhão, Brazil). Random allocation by lot of treatments (PDT +~     LLL and LLL) to quadrants of the oral cavity was performed, and the patient was his own~     control. Patients were masked about therapy performed on each side of the arch. The~     evaluation period of both therapeutic regimens was 8 days, and the outcome assessed was the~     lesion size (measured in cm²). Friedman and Wilcoxon tests were applied and the effect~     magnitude calculated. The significance level was 5%. Statistically significant difference was~     observed between the groups for the lesion diameter of the 6th to the 8th day (greater~     regression of lesion size for the PDT + LLL group), which was confirmed by a difference~     magnitude moderated. Based on the findings, it is concluded that PDT + LLL showed greater~     therapeutic effect when compared to LLL in reducing the severity of OM lesions.~   "
77278|NCT02555488|"~     The aim of this study was to compare the Antibacterial Efficacy of Diode Laser 810nm and~     Photodynamic therapy in reducing bacterial microflora in endodontic retreatment of teeth with~     periradicular lesion.~   "
77279|NCT02555475|"~     The Prime Study is a randomised trial investigating models of care for hepatitis C in the era~     of direct acting antiviral (DAA) therapy. The study aims to compare outcomes of hepatitis C~     care and DAA treatment provided in a primary health care service with a tertiary hospital.~   "
77280|NCT02555462|"~     Integration of the REM-verification within the fitting workflow will enable the hearing care~     professional to easily run real ear measurements. The purpose of the two study parts is to~     prove that an integrated cooperative system, consisting of fitting software and measurement~     system, matches desired responses for certain stimuli faster, more reliably and more~     precisely at the ear drums of hearing instrument wearers than current best practice~     processes.~   "
77281|NCT02555449|"~     The purpose of this study is to measure how much of the specially prepared study drug,~     LY3202626, containing radiolabeled carbon [¹⁴C] gets into the blood stream and how long it~     takes the body to get rid of it.~      Information about any side effects that may occur will also be collected.~      Participants will stay at a clinical research unit (CRU). The study will last about 28 days~     (check in to follow-up) for each participant.~      This study is for research purposes only and is not intended to treat any medical condition.~   "
77282|NCT02555423|"~     The aim of the study is to determine the effectiveness of serratus place block in the control~     of post-operative pain following mastectomy. The investigators will compare one group of~     patients receiving serratus plane block and wound infiltration to a control group receiving a~     saline injection into serratus anterior and wound infiltration with local anaesthetic only.~     The investigators will compare our results to the National Mastectomy and Breast~     Reconstruction Audit's reported rate of 6.2% of patients reporting severe pain following~     mastectomy to see if there is an improvement of the national standard. In the serratus block~     group, the investigators expect a 50% decrease in the number of patients who report severe~     pain day one post operatively.~   "
77283|NCT02555410|"~     This is a phase III, pilot, prospective study of an Electromyography (EMG) based seizure~     detection system for detecting Generalized Tonic-Clonic Seizures (GTCS) in the home.~   "
77284|NCT02555397|"~     The primary purpose of this phase 1 study is to determine the dose-dependent toxicity and~     maximum tolerated dose (MTD) of oncolytic adenovirus-mediated cytotoxic and IL-12 gene~     therapy in men with locally recurrent prostate cancer after definitive radiotherapy~   "
77285|NCT02555384|"~     Amblyopia, affects 4% of the population. In the presence of a normal retina and optic nerve,~     the visual cortex does not develop normally secondary to the amblyopic eye being at a~     disadvantage in the sensitive period such as in strabismus. Amblyopia is associated with~     visuospatial disorders, and poor to absent stereopsis. Amblyopia is treated by occlusion of~     the non- amblyopic eye in childhood. The present study aims to evaluate the effectiveness of~     perceptual learning (PL), that is a training of visual drawing tasks (12 sessions of 30~     Minutes duration) with crowding (c) for children with amblyopia compared to an amblyopic~     control group with a placebo drawing task.~      Arm 1: Crowded (PLc)- Training with small spacing Arm 2: Uncrowded (PLu)- Training with large~     spacing Prior to this, a small group will help optimize parameters such as contrast and~     distance of visual objects presented~   "
77300|NCT02555189|"~     This partially randomized phase IB/II trial studies the side effects and best dose of~     ribociclib when given with enzalutamide and to see how well they work compared to~     enzalutamide alone in treating patients with prostate cancer that does not respond to~     treatment with hormones (hormone resistant), has spread from the primary site (place where it~     started) to other places in the body (metastatic), is chemotherapy naïve, and retains~     retinoblastoma expression. Testosterone can cause the growth of prostate cancer cells.~     Hormone therapy using enzalutamide may fight prostate cancer by blocking the use of~     testosterone by the tumor cells. Ribociclib may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth. It is not yet known whether enzalutamide works~     better when given with or without ribociclib in treating patients with prostate cancer.~   "
78648|NCT02537470|"~     This is a dose-ranging study to evaluate the efficacy, safety and tolerability of a range of~     doses of a biphasic formulation of remogliflozin etabonate compared to placebo, administered~     over 12 weeks in subjects with type 2 diabetes mellitus.~   "
77286|NCT02555371|"~     Primary objective of the study is to evaluate whether patients with severe eosinophilic~     asthma who have received long-term treatment with mepolizumab (at least 3 years) need to~     maintain treatment with mepolizumab to continue to receive benefit. Subjects who participated~     in the open-label studies MEA115666 or 201312 with at least 6 months of treatment with~     mepolizumab prior to Visit 1 and who have no more than 2 consecutive missed doses of~     mepolizumab treatment will be eligible to participate in this study. This study will be~     conducted in 4 parts in approximately 300 subjects. Part A will be Variable Open-Label Run-in~     (for subjects with less than 3 years of mepolizumab treatment). Once the required 3 year~     exposure is reached, subjects will enter Part B- Fixed Open-Label Run-In (4 weeks to 8~     weeks). During Part A and B subjects will be administered Open-label mepolizumab (100~     milligram [mg] Subcutaneous [SC]) every 4 weeks. Part C will be the randomized double-blinded~     part. Upon completion of Part B, eligible subjects will be randomized to mepolizumab (100 mg~     SC) every 4 weeks or placebo administered SC every 4 weeks for 52 weeks.~      Subjects discontinuing investigational product (IP) due to a clinically significant asthma~     exacerbation will then enter optional Part D of the study. During Part D, subjects receive~     open-label mepolizumab in addition to their standard of care therapy for the remainder of the~     study, through Part D up to 52-weeks post-randomization. An Exit Visit will be conducted 52~     weeks after randomization in order to assess subject's efficacy parameters, immunogenicity~     status, and to conduct additional safety assessments. Eligible subjects will participate in~     the study ranging from 56 to192 weeks, depending on the duration of Part A (0 to 132 weeks)~     and Part B (4 to 8 weeks).~   "
77287|NCT02555358|"~     The purpose of this study is to assess the relationship of pCR rate and efficacy by comparing~     the two drugs and three drugs as neoadjuvant chemotherapy in advanced gastric cancer~     patients.~   "
77288|NCT02555345|"~     This study aims to identify and validate the gene expression differentials of peripheral~     blood mononuclear cells and differential inflammation profiles and other aspects in classic~     asthma, cough-variant asthma and eosinophilic bronchitis.~   "
77289|NCT02555332|"~     This study was conducted to analyze the role of TSH level and TPOAb status in early pregnancy~     and use this information in assessment of the risk of gestational diabetes mellitus at~     different weeks of gestation when the FT4 level is normal.~   "
77290|NCT02555319|"~     The purpose of this study is to evaluate the safety and short-term effectiveness of~     implantation of Transcatheter Pulmonary Valve (TPV) for the treatment of congenital heart~     disease with pulmonary valve disease.~   "
77291|NCT02555306|"~     The purpose of the study is to evaluate the safety, tolerability, immunogenicity, and~     bioactivity of a single intravitreal (IVT) administration of DE-122 in subjects with~     refractory exudative age-related macular degeneration (AMD).~   "
77292|NCT02555293|"~     Surgery is in almost all cases the only potentially curative treatment option for patients~     with primary or secondary malignancies of the liver. However, in most cases oncological~     resections (R0-resections) can only be achieved by performing major liver resections (4 or~     more liver segments), which is related to considerable postoperative complications such as~     systemic infections and postoperative liver insufficiency (postresectional liver failure~     (PRLF)). Despite optimized preoperative and postoperative strategies of care presently, up to~     32-55% of patients display severs postoperative complications (Clavien score ≥ 3a) and 5%~     even suffer from a severe PRLF. Recent observations in murine disease models as well as human~     patients suggested that postoperative alterations of hemodynamics within the portal vein~     tract as well as postoperative modulations of the immune response facilitates the~     translocation of gut bacteria in the blood, leading to systemic infections and sepsis.~     Moreover it became apparent that inflammatory mediators, released by the gut microbiota might~     negatively affect postoperative liver regeneration. Rifaximin (Xifaxan®) is a novel and~     potent, semisynthetic antibiotic that efficiently acts against most enteric bacteria and~     significantly reduced liver inflammation and liver fibrosis in animal studies. Moreover,~     Rifaximin is very well tolerated, even in patients with liver insufficiency.~   "
77293|NCT02555280|"~     A 2 and 5 year comparative evaluation of clinical outcomes in the treatment of degenerative~     spinal stenosis with concomitant low back pain by decompression with and without additional~     stabilization using the coflex® Interlaminar Technology for FDA Real Conditions of Use Study.~   "
77294|NCT02555267|"~     This study investigate the impact of comprehensive geriatric assessments using activity of~     daily living (ADL), instrumental activity of daily living (IADL), and Charlson's comorbidity~     index (CCI) on survival and toxicities in Korean patients with diffuse large B-cell lymphoma~     (DLBCL) treated with R-CHOP.~   "
77295|NCT02555254|"~     Comparing the production of interleukin 6 (inflammatory cytokine) in two heating speed (slow~     rewarming rate: 0.25 ° C / h or fast rewarming rate 0.50 ° C / h) at the completion of a~     period of targeted temperature at 33°C after cardiac arrest supported by shockable rhythm and~     successfully resuscitated.~   "
77296|NCT02555241|"~     The purpose of this study is to investigate the effects of several applied behavior teaching~     procedures on the use of multi-word utterances by children with autism.~   "
77297|NCT02555228|"~     A randomized controlled and endoscopist-blinded study which compares the efficacy of liquid~     simethicone (100mg) in 5 mls water, versus placebo ( 5mls of water), as premedication (given~     at least 30 minutes) before gastroscopy towards improvement of the total mucosal visibility~     score.~   "
77298|NCT02555215|"~     The primary objective of the study is to evaluate the long-term safety of BG00012 in subjects~     who completed Study 109MS202 (NCT02410200). Secondary objectives are as follows: To evaluate~     the long-term efficacy of BG00012 and to describe the long-term Multiple Sclerosis (MS)~     outcomes in subjects who completed Study 109MS202 (NCT02410200).~   "
77299|NCT02555202|"~     The main objective of this study is to develop and to validate a French version of the London~     Chest Activity of Daily Living (LCADL) and the Dyspnea 12 and to determine the reliability of~     this version for the evaluation of the dyspnea in the Activity of Daily Living in COPD~     patients (stages severe and very severe).~   "
77301|NCT02555176|"~     This pilot clinical trial studies the effects of a low carbohydrate diet on tumor metabolism~     in patients with head and neck cancer. A low carbohydrate diet may reduce the metabolic~     activity of cancer cells and of surrounding supportive tissues. Studying samples of tissue~     and blood from patients with head and neck cancer in the laboratory before and after a low~     carbohydrate diet may help determine any changes in tumor metabolism.~   "
77304|NCT02555137|"~     This is a prospective, international, multicenter outcome cohort study. This study starts at~     the moment patients visit the outpatient clinic 3 to 6 months after a diagnosis of acute PE~     as part of routine medical care. If patients consent to study participation, the CTEPH~     clinical prediction score will be calculated. CTEPH is considered to be not present in~     patients with a low probability (≤6 points) and no symptoms suggestive of CTEPH, i.e. dyspnea~     on exertion, edema, newly developed palpitations, syncope or chest pains.The remaining~     patients with either high probability (>6 points) or who report symptoms that may be~     associated with CTEPH will be subjected to the 'rule-out criteria'. CTEPH will be assumed not~     present in patients with an age- and gender dependent normal NT-proBNP level (as defined by~     the assay's manufacturer), in the absence of any of the 3 ECG criteria. Patients who have an~     abnormal result from the 'rule-out criteria' will be referred for transthoracic~     echocardiography. All echocardiograms will be performed according to a predefined~     standardized protocol.~      In case of echocardiographic intermediate or high probability of PH, patients will be~     referred for further diagnostic work-up of suspected CTEPH starting with perfusion lung scan~     or VQ-scan and right heart catheterization, of which the results will be discussed by an~     independent interdisciplinary working group of PH specialists, to ensure optimal diagnostic~     management. This latter diagnostic work-up of an abnormal echocardiograph lies within the~     setting of standard medical care.~      All patients who were not diagnosed with pulmonary hypertension of any origin, or with NYHA~     class III or IV heart failure due to left ventricular systolic dysfunction, left ventricular~     diastolic dysfunction or significant valvular lesions, will be followed for a total of 2~     years from the index PE diagnosis. During that period, the study protocol will not interfere~     with standard patient care, allowing diagnostic tests as deemed indicated by the treating~     physician including echocardiography in case of new respiratory symptoms. At the end of the~     follow-up period, all patients will be subjected to a second echocardiography that will be~     handled according to the above stated procedures to evaluate the presence of CTEPH.~   "
77305|NCT02555124|"~     The purpose of this study is to evaluate the safety of JNJ-42847922 following single oral~     administration.~   "
77306|NCT02555111|"~     Open randomized therapeutic study to assess the efficacy of Xarelto 15mg/day in the~     recurrence of thromboembolic event compared to an untreated group in patients with chronic~     portal vein thrombosis without high risk thrombophilia.~   "
77307|NCT02555085|"~     The primary objective of the study is to evaluate the safety and tolerability of single~     ascending intravenous (IV) doses and a single subcutaneous (SC) dose of BIIB063 in healthy~     volunteers. The secondary objectives of the study are to estimate the PK parameters of single~     ascending IV doses of BIIB063; to estimate the PK parameters and absolute bioavailability (F)~     of a single SC dose of BIIB063; and to evaluate the immunogenicity of single ascending doses~     of BIIB063.~   "
77308|NCT02555072|"~     This is a Phase IV study cohort, uncontrolled, composed of two segments: children and healthy~     adults. It will be included 2756 children and 2005 adults, evaluated initially in six~     different times (before vaccination, 30-45 days, 1 year, 4 years, 7 years and 10 years after~     vaccination). The Paraiba state was selected for the study because in this region there are~     no yellow fever virus dissemination and therefore no NIP recommendation for people's routine~     vaccination. However, the NIP indicate yellow fever vaccination for individuals who are~     moving to areas with virus circulation. The study will take place in six (6) Basic Health~     Units of three (3) municipalities (2 units per municipality) in the state of Paraíba. The~     selected municipalities are: Alhambra, Caaporã and Conde. The study target population~     consisted of healthy children and adults of both sexes. Children must be between 9 months and~     4 years,11months and 29 days; adults between 18 and 50 years. It will be eligible for the~     study, people who have never received the yellow fever vaccine checked in vaccine design and~     history and who agree to participate. Not be included participants with any contraindication~     to vaccination against yellow fever and individuals who previously moved to risk areas for~     extended periods. The study main objective is to assess the immune status of children and~     adults who have never vaccinated, they will receive the first dose of 17DD yellow fever~     vaccine provided by the study and will be monitored for 10 years. Depending on the results of~     the analyzed of the data, the period of monitoring may be extended.~   "
77309|NCT02555059|"~     The objective in this study is collecting post-marketing information on the safety and~     efficacy of Ciproxan injection under the routine clinical practice.~   "
77310|NCT02555046|"~     The purpose of this study is to determine the effect of General versus Local Anaesthesia on~     muscle and cerebral oxygenation under EVAR-treatment in a prospective unblinded randomised~     controlled trail.~   "
77311|NCT02555033|"~     Aging results in a gradual decline of physical abilities and consequently in functional~     impairments which increases the risk of falls in elderly people. It has been shown, that~     balance and resistance training can counteract the effects of aging. The aim of this study~     was to investigate effects of instability resistance training (IRT), combining balance and~     resistance training, on measures of muscle strength / power and balance for falls in healthy~     community-dwelling older adults. Therefore 75 elderly people, aged 65 - 80 years (Mage =~     70.4; SD = 4.3 years) were assigned into three intervention groups: machine-based (M-RT),~     machine-based instability (M-IRT), free weight instability resistance training (F-IRT). All~     three groups exercised over 10-weeks with two training sessions per week. Assessment of~     muscle strength (e.g. maximal isometric leg extension strength), power (e.g. chair rise test)~     and balance (e.g. gait, functional reach test) was conducted before and after training.~      Based on the principle of training specificity, it is assumed, that groups to improve better~     within their respective training modality. Thus, the investigators hypothesis that regarding~     measures of strength and power, M-RT performs better than M-IRT, performs better than F-IRT.~     As to measures of balance, we hypothesis that F-IRT performs better that M-IRT, performs~     better than M-RT.~   "
77312|NCT02555020|"~     Carbohydrate loading is an important component of enhanced recovery pathways. Preoperative~     carbohydrate treatments have been widely adopted as part of enhanced recovery after surgery~     (ERAS) or fast-track surgery protocols. Although fast-track surgery protocols have been~     widely investigated and have been shown to be associated with improved postoperative~     outcomes, some individual constituents of these protocols, including preoperative~     carbohydrate treatment, have not been subject to such robust analysis.To assess the effects~     of preoperative carbohydrate treatment, compared with placebo or preoperative fasting, on~     postoperative recovery and insulin resistance in adult patients undergoing elective surgery.~   "
77324|NCT02554864|"~     The adductor canal block (ACB) is the standard of care for analgesia after Anterior Cruciate~     Ligament (ACL) repair. ACB is performed by injecting local anesthetic (freezing) in the~     subsartorial canal in the thigh which is about 7-10cm long. Preliminary evidence suggests~     that different injection sites within the canal may produce different degrees of analgesia~     and quadriceps motor block. This trial seeks to determine the effects of various ACB~     injection sites on postoperative analgesia and motor power following ACL repair.~   "
77313|NCT02555007|"~     Background: Metronomic oral Vinorelbine has efficacy in metastatic NSCLC and malignant~     Pleural Mesothelioma, but all the studies published thus far were based upon a variety of~     empirical and possibly suboptimal schedules, with inconsistent results. Mathematical modeling~     showed by simulation that a new metronomic protocol could lead to a better safety and~     efficacy profile.~      Design: This phase Ia/Ib trial was designed to confirm safety (phase Ia) and evaluate~     efficacy (phase Ib) of a new metronomic oral vinorelbine schedule. Patient with metastatic~     NSCLC or malignant Pleural Mesothelioma, after failure of standard treatments, ECOG 0-2 and~     an adequate organ functions, will be eligible. Our mathematical PK-PD model suggested an~     alternative weekly D1, D2 and D4 innovative schedule (named Vinorelbine Theoretical Protocol)~     with a dynamic intake of 60, 30 and 60 mg, respectively. Trial recruitment is two-staged as~     12 patients are planned to participate in the phase Ia, to confirm safety and consolidate the~     calibration of the average parameters of the model. Depending the phase Ia result, and after~     favorable decision of a consultative committee, the extension phase (phase Ib) will be an~     efficacy study and will include a number of 20 patients receiving the Optimal Vinorelbine~     Theoretical Protocol. The primary endpoint is the tolerance (assessed by CTC v4.0) for the~     phase Ia and the objective response according to RECIST 1.1 for the phase Ib.~      An ancillary study on circulating angiogenesis biomarkers will be a subproject of the trial.~      Discussion: this ongoing trial is the first to prospectively test a mathematical optimized~     schedule in metronomic chemotherapy. As such, this trial can be considered as a~     proof-of-concept study demonstrating the feasibility to run a computational-driven protocol~     to ensure an optimal efficacy/toxicity balance in patients with cancer.~   "
77314|NCT02554994|"~     Frailty is a highly prevalent, progressive condition in older adults that is characterized by~     multisystem physiologic impairments and vulnerability to stressful events, leading to~     increased risk of geriatric conditions, disability, falls, hospitalization, and mortality. An~     effective public health intervention to improve frailty in a rural aging population with~     limited resources remains unknown. The purpose of our study is to evaluate the effectiveness~     of multidimensional public health intervention to reduce frailty and related geriatric~     conditions in older adults in rural communities. Our hypotheses are that a multidimensional~     intervention consisting of group exercise, nutritional support, depression management,~     polypharmacy, and home safety intervention over a 6-month period will improve frailty and~     selected geriatric conditions in older adults who are in low socioeconomic status or living~     alone in a rural community. Our primary outcome is short physical performance battery at 6~     month. Secondary outcomes include frailty status, nutritional status, depression, falls,~     sarcopenia, and health care utilization. The investigators will conduct a designed delay~     trial by implementing our intervention in one town for the first 6 months (intervention~     group), while measuring the outcomes without any intervention in another town (serving as a~     control group); in the following 6 months, the investigators will implement the 6-month~     intervention in the control town. The findings from our study will inform us to find~     effective public health interventions to promote healthy aging in resource-limited, rural~     populations.~   "
77315|NCT02554981|"~     This study will evaluate the efficacy of Restasis® in participants with dry eye disease who~     engage in electronic visual tasking.~   "
77316|NCT02554968|"~     This study will utilize Rasch analysis to study the construct validity and reliability of~     five shoulder-related patient-reported outcome measures in patients reporting shoulder~     impairment following surgery for head and neck cancer.~   "
77317|NCT02554955|"~     This study will evaluate the efficacy and safety of intravenous daclizumab in combination~     with oral mycophenolate mofetil and oral sirolimus in participants receiving a heart~     transplant, and at risk of impaired kidney function. The anticipated time on study treatment~     is 6 months, and the target sample size is 44 individuals.~   "
77318|NCT02554942|"~     This study will evaluate the safety of subcutaneous (SC) epoetin beta (NeoRecormon) in adults~     with solid tumors being treated with platinum-based chemotherapy capable of inducing anemia.~     The anticipated time on study treatment is 16 weeks, and the target sample size is~     approximately 208 individuals.~   "
77319|NCT02554929|"~     This study is to assess the efficacy of a brief, 11-week, manualized Taming Sneaky Fears for~     Social Anxiety Disorder (SAD) and/or Selective Mutism (SM) child and parent group Cognitive~     Behavioural Therapy (CBT) treatment protocol. Children 4 to 7 years old (n = 88) meeting~     criteria for SAD and/or SM, and their parents are recruited from the Psychiatry Outpatient~     Program and participants will be randomized to either the Taming Sneaky Fears group or a~     parent psycho-education and child socialization group. Trained clinicians blinded to all~     measures and treatment assignment will administer pre, post and 6-month follow-up outcome~     measures. Investigators assess within-the-child and within-the-parent/environment factors~     that predict treatment outcomes.~   "
77320|NCT02554916|"~     This is an exploratory study designed to investigate the effects of aerobic dual belt~     treadmill walking versus traditional treadmill exercise on gait performance and functional~     capacity in older adults at risk for mobility disability. Identifying the relationship~     between aerobic treadmill exercise (dual belt or traditional) and the recovery of walking~     abilities will serve to optimize current rehabilitation approaches.~   "
77321|NCT02554903|"~     STUDY OBJECTIVES Primary objective To evaluate the effect of macitentan 10 mg on pulmonary~     vascular resistance (PVR) as compared to placebo in subjects with pulmonary hypertension (PH)~     after left ventricular assist device (LVAD) implantation.~      Secondary objectives To evaluate the effect of macitentan 10 mg as compared to placebo on~     cardio-pulmonary hemodynamics and disease severity in subjects with PH after LVAD~     implantation.~      To evaluate the safety and tolerability of macitentan 10 mg in subjects with PH after LVAD~     implantation.~      Exploratory objectives To explore the potential effect of macitentan 10 mg as compared to~     placebo on right ventricular function in subjects with PH after LVAD implantation.~      To explore the potential effect of macitentan 10 mg as compared to placebo on selected~     clinical events in subjects with PH after LVAD implantation.~      To explore the potential effect of macitentan 10 mg as compared to placebo on renal function~     as measured by glomerular filtration rate (GFR) in subjects with PH after LVAD implantation.~   "
77322|NCT02554890|"~     The purpose of this study is to assess the effect of in-hospital initiation of~     sacubitril/valsartan (LCZ696) vs. enalapril on time averaged proportional change in NT-proBNP~     in patients who have been stabilized following hospitalization for acute decompensated heart~     failure (ADHF) and reduced ejection fraction (left ventricular ejection fraction (LVEF) ≤~     40%).~   "
77323|NCT02554877|"~     The purpose of this study is to determine whether PF-06291874 is effective in the treatment~     T2DM~   "
77377|NCT02554175|"~     The aim of this study was to determine the target propofol concentration needed to provide~     adequate hypnosis for induction and tracheal intubation for Schnider model using total body~     weight (TBW) in parturients. In addition, investigators wanted to define the hemodynamic~     adverse effects associated with these propofol target concentrations.~   "
77325|NCT02554851|"~     Phase III clinical trial, multicenter, controlled, randomized, double-blind, with two~     parallel groups (experimental and control). Both study groups will receive standard therapy~     currently available in treatment centers for diabetic foot ulcer (DFU). Associate with the~     standard therapy, it will be given the recombinant human Epidermal Growth Factor (rhEGF) to~     experimental group and in the control group, it will be given a formulation without~     pharmacological effect (placebo) in order to masking and control of intralesional~     application. Participants with type 1 and type 2 diabetes mellitus (DM) diagnosed with DFU~     for at least 4 weeks, treated in referral centers participating in the study, agreeing to~     participate after reading, understanding and signing of Informed Consent (IC); meet all the~     inclusion criteria; and presenting no exclusion criteria. The Informed Consent (IC) should be~     applied to potential participants, as recommended by the regulations and ethical consensus~     before beginning any procedure related to the clinical trial. In the early weeks,~     participants will be evaluated at the research centers by the study team (doctors and / or~     staff). The number of visits will be determined by the investigator, thus ensuring~     appropriate assistance to participants, and avoiding any complications with DFU. By meeting~     the eligibility requirements (inclusion and exclusion criteria), the participant will undergo~     a thorough evaluation of the DFU before the start of treatment. This assessment is precisely~     to classify the condition of the ulcer before treatment and provide relevant information for~     statistical analysis of the protocol. If eligible, the participant will be randomly set to~     treatment arm (placebo or rhEGF) and the administration of investigational product associated~     with predefined standardized outpatient therapy will be initiated. This administration occurs~     three times per week until the DFU is scarred, not exceeding 8 weeks of treatment (T.01 to~     T.08) .The study will be randomized and balanced according to the type and size of the DFU.~     This balancing is necessary to ensure that both treatment groups are homogeneous for~     participants under different conditions. All participants will be applied established~     standard therapy for the treatment of DFU. The objective is to provide regular care for~     healing and reduce possible bias in the efficacy analysis and product safety. After the~     treatment period (last dose of the experimental drug) the participant will start the~     follow-up period, with 16 weeks duration. The participant shall be subjected to weekly visits~     for ongoing assessment of DFU, however, according to the investigator, may result in~     unscheduled visits to assess local or general clinical events. After the monitoring period,~     the participant will be observed for 24 additional weeks, visits every 4 weeks (E.01 E.24 a)~     having beginning one week after the last visit of follow-up. This period is intended to~     assess possible events related to the efficacy and safety that can happen in the period,~     mainly for analysis of secondary endpoints.~   "
77326|NCT02554838|"~     This project aims to determine the respective impacts of two routine care regarding phobic of~     falling seniors on the mobility restriction. The investigators used a monocentric, randomized~     and controlled research according to two parallel groups : physical activity, home assessment~     and modification (rehabilitation group) versus physical activity, home assessment and~     modification with cognitive behavioral therapy (CBT) (rehabilitation and CBT group). The~     investigators will assess the efficacy of usual care (rehabilitation group) and the~     supplementary benefit of CBT (rehabilitation and CBT group) with the Life Space Assessment.~   "
77327|NCT02554825|"~     This study evaluated the impact of the three-year Healthy Futures program on teen sexual~     behaviors in three Massachusetts cities.~   "
77328|NCT02554812|"~     This is a Phase 1b/2 dose-optimization study to evaluate safety, pharmacokinetics,~     pharmacodynamics, and preliminary antitumor activity of avelumab (MSB0010718C) in combination~     with other cancer immunotherapies in patients with locally advanced or metastatic solid~     tumors. The primary purpose is to assess the safety and early signs of efficacy of various~     avelumab combinations with other cancer immunotherapies, optimizing dosing regimens as~     appropriate, in a limited series of indications.~   "
77329|NCT02554799|"~     This study will be conducted in a single centre, as an open single dose two parallel cohorts~     design with oral doses of MMV390048 administered in healthy male and female subjects between~     18 to 55 years of age. Subjects will be screened within 28 days prior to entering the study.~     On Day 1 of the study each subject will receive one of the two MMV390048 prototype~     formulations, at a dose of 40 mg with 240 mL of water. Subjects will be discharged on Day 3~     after 48h post-dose and they will attend the unit for follow-up visits on Days 5, 7, 10, 14,~     19, 26 and 29.~   "
77330|NCT02554786|"~     The purpose of the trial is to evaluate the efficacy and safety of two different doses of~     QMF149 (QMF149 150/160 µg and QMF149 150/320 µg via Concept1) over two respective MF doses~     (MF 400 µg and MF 800 µg via Twisthaler® (total daily dose)) in poorly controlled asthmatic~     patients as determined by pulmonary function testing, and effects on asthma control~   "
77331|NCT02554773|"~     The purpose of this study is to evaluate the long-term safety and tolerability of ALN-AT3SC~     in male patients with moderate or severe hemophilia A or B.~   "
77332|NCT02554760|"~     Evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction in the~     flank using an applicator with the Crown Cooling Insert.~   "
77333|NCT02554747|"~     Diabetic macular edema (DME) in diabetic retinopathy (DR) is the leading cause of visual~     impairment among the 300,000 Danish patients with diabetes (DM) and will in time affect 29%~     of patients. Because of DME, 550 intravitreal injections were given at Odense University~     Hospital in 2014 with medicine expenses approximating 3.3 million DKK. With an increasing~     prevalence of diabetes, the number is expected to rise significantly for the years to come.~      The investigators hypothesize that combination therapy with intravitreal aflibercept and a~     new computer navigated photocoagulations system (Navilas®) leads to a decreased need for~     intravitreal injections.~      Further, the investigators wish to identify retinal risk markers for DME treatment outcome to~     assist individualized treatment planning. The evaluation of the baseline level of macular~     ischemia as marker of successful treatment outcome is of particular interest as this is still~     highly debatable and may prove a significant prognostic factor of anatomical and functional~     outcome to anti-VEGF treatment.~      The ADDENDUM study (four-year part-time PhD study) is a 12-month prospective randomized 1:1~     study to compare intravitreal aflibercept and Navilas® laser (Group A) with intravitreal~     aflibercept and conventional Pascal laser (Group B) in the treatment of DME.~      Eligibility criteria: DM, age 18-99, clinically significant macular edema, central retinal~     thickness > 300 μm, best corrected visual acuity 35-75 Early Treatment Diabetic Retinopathy~     Study (ETDRS) letters.~      The investigators believe that this study holds the potential to set precedent for a new gold~     standard of DME-treatment with increased treatment effect, reduced risks and a more~     cost-effective approach.~   "
77334|NCT02554734|"~     Phase I open, randomized cross-over pharmacokinetic study.~   "
77335|NCT02554721|"~     The primary objective of this study is to investigate the effects of Cilostazol,~     Acetylsalycylic acid and Clopidogrel alone as well as combinations of~     Cilostazol/Acetylsalicylic acid and Cilostazol/ Clopidogrel on ex-vivo Platelet Function (PF)~     testing.~   "
77336|NCT02554708|"~     To assess safety and efficacy of pCONus for the treatment of wide neck bifurcation aneurysms.~   "
77337|NCT02554695|"~     This protocol addresses: 1) How gene expression changes in bone cells are affected by aging?~     2) Is aging associated with decreased signaling between bone cells? 3) How does treatment~     with the osteoporosis medication denosumab affect bone cell signaling?~   "
77338|NCT02554682|"~     The primary objective is to conduct a pilot study to determine the efficacy of evidence-based~     interventions delivered in primary care clinic settings on parent-teen health communication.~   "
77339|NCT02554669|"~     Physical activity performed in the postprandial state has the ability to blunt postprandial~     glycemia acutely, even as a result of very light or small amounts of postprandial physical~     activity. Postprandial physical activity decreases postprandial glycemia more effectively~     than activity performed in the post-absorptive state. However, studies comparing postprandial~     and postabsorptive physical activity have measured glycemic outcomes in only short periods of~     time (hours) or have used a very large dose of physical activity.~      Physical activity have the ability to entail an acute increase in markers of systemic~     inflammation.Previous studies has also shown that systemic inflammation is increased during~     glycemic spikes, such as after a high carbohydrate load. Therefore the effect of postprandial~     physical activity is difficult to predict. One one hand it might increase markers of systemic~     inflammation. On the other hand it might decrease systemic inflammation as a result of a~     blunting effect on postprandial glycemia. The effect of physical activity after carbohydrate~     intake might therefore also differ from postabsorptive physical activity.~      Purpose of the study: I) The investigators hypothesized that light physical activity~     performed in the post-prandial sate decrease blood glucose in a day and night cycle compared~     to the same activity performed in the postabsorptive state and a control day. II) To test~     whether postabsorptive and postprandial light physical activity do affect markers of systemic~     inflammation different.~      12 participants diagnosed with hyperglycemia but not on hypoglycemic medication took part in~     a randomized cross-over trial with 3 test days. A control day with no physical activity, and~     two days similar to the control day except that one of them contained a one hour bout of~     treadmill walking prior to breakfast and the other a similar exercise bout after breakfast.~     Continuous glucose monitoring was performed from start of exercise / breakfast until the~     morning next day (at least 22 hours). Venous blood was also sampled at given timepoints~     (before exercise / before breakfast, and 1.5, 2.5, 3.5 and 24 hours after breakfast. Dietary~     intake was individually standardized prior to and during test days.~   "
77340|NCT02554656|"~     Examine the safety and effectiveness of Vfend [voriconazole] for pediatric under general~     clinical practices.~   "
77341|NCT02554643|"~     The present study aims to evaluate the impact of a soccer training program lasting 12 weeks~     in patients with type 2 diabetes mellitus. 60 sedentary adults and elderly patients with type~     2 diabetes mellitus (age: 50-75 y), with a BMI > 25kg/m2 and > 29kg/m2, respectively, from~     the Hospital of the Medical Faculty of São Paulo University will participate in this study.~     They will be randomly divided in 3 groups (soccer, running and control). All patients will~     undergo the following assessments: anthropometric, dietary, physical performance,~     inflammatory, metabolic and hormonal parameters such as gene expression, bone markers and~     predictors of cardiovascular disease. In addition the investigators aim to evaluate the body~     composition of these patients by DXA, and muscle and visceral lipids content by proton~     spectroscopic MRI.~   "
77342|NCT02554630|"~     Mortality related to neonatal sepsis exceeds 1 million deaths worldwide; the highest risk of~     mortality is in preterm neonates, especially low birth weight (LBW), and very low birth~     weight (VLBW) neonates. The estimated cost of caring for these patients is approximately $700~     million in the US alone.~      In an effort to help mature the neonatal immune system, several adjuvant therapies have been~     studied; however, none have been implemented in clinical practice. One of the most frequently~     considered targets for adjuvant therapy is toll-like receptors (TLRs). TLRs detect conserved~     molecular products of microorganisms (lipopolysaccharide (LPS), and initiate immunity and~     inflammation. Early adjuvant administration in VLBW infants may be a viable approach to~     reducing the incidence of early and late sepsis.~      This research study will characterize immune genomic expression and functional capacity at~     the time of birth in both term and preterm neonates and determine what effects, if any, that~     adjuvants have on this function. Additionally, this study will seek to determine if immune~     function correlates with certain microbiota.~   "
77343|NCT02554617|"~     The purpose of this study is to determine fractional exhaled nitric oxide (FeNO) level in~     healthy subjects among Thai populations.~   "
77344|NCT02554604|"~     The study is design to assess if there is a correlation between diagnosis of preeclampsia and~     its severity to changes in HDL quality, in terms of composition and function and to determine~     whether preeclampsia-induced changes in VOCs in saliva can be used for the early diagnosis of~     preeclampsia.~   "
77345|NCT02554591|"~     The investigators propose to conduct a retrospective study of single agent ceritinib in~     patients with previously untreated anaplastic lymphoma kinase (ALK) rearranged adenocarcinoma~     of the lung with the sole purpose of characterizing the genomic landscape before ceritinib~     and at the time of disease progression.~   "
77346|NCT02554578|"~     The purpose of this study is to improve medication adherence, engagement and support to heart~     transplant patients through implementation of a new clinical care programme conducted by the~     clinical pharmacy service in cooperation with the heart transplant team and supported by~     mobile health (mHealth).~   "
77347|NCT02554565|"~     Quantification and follow-up of circulating tumoral DNA in serum and/or plasma of patients~     with cervical cancer compared to the early detection of minimal metastatic disease.~   "
77348|NCT02554552|"~     This is a multicenter, randomized, double-blinded, parallel, placebo-controlled, phase I/IIa~     clinical trial of YY1201 for treatment of osteoarthritis of the knee.~   "
77349|NCT02554539|"~     The purpose of this study is to understand the mechanism of communication between the uterine~     environment and the preimplantation human embryo. The investigators are interested in~     understanding how the in-utero environment during the window of implantation is different in~     normal weight and overweight/obese women and how this may impact the programming of the~     developing embryo.~   "
77350|NCT02554526|"~     Using whole blood samples and plasma samples obtained from some hemophilia A patients with~     inhibitors, the investigators will perform the coagulation assessment in the co-presence of~     aPCC and factor VIII by comprehensive coagulation assays and flow chamber analysis under~     blood flow conditions.~   "
77351|NCT02554513|"~     The purpose of the proposed research is to examine the effects of two treatment approaches on~     speech production involving speakers with chronic apraxia of speech (AOS) and aphasia. The~     planned investigation is designed to examine the acquisition, maintenance and generalization~     effects of each treatment. One approach, electropalatography (EPG) uses visual biofeedback in~     conjunction with articulatory-kinematic treatment and the other approach, sound production~     treatment (SPT) is one of the most systematically studied articulatory-kinematic treatments~     for AOS.~   "
77352|NCT02554500|"~     In trauma surgery and hand surgery treatment strategies of none healing bone fractures aim at~     replacing pseudarthrosis by well vascularized bone and improving microcirculation. Although~     previous studies indicate that remote ischemic preconditioning (RIPC) can accelerate bone~     healing in case of non-union, only a few studies focused on the elucidation of its mechanisms~     of action. Therefore, the aim of this study is to evaluate the microcirculatory effects of~     remote ischemic preconditioning (RIPC) on scaphoid bones and metacarpal bones and metatarsal~     bones in a human in-vivo setting for the first time.~   "
77378|NCT02554162|"~     This study examines if there are differences in satiety responses between structurally~     different wholegrain rye products.~   "
77379|NCT02554149|"~     The purpose of this study was to develop a radiological method to measure stem anteversion~     and to determine its validity and reliability.~   "
77353|NCT02554487|"~     Investigating the interrelation of stroke and sleep-disordered breathing (SDB) is of major~     importance. First because of the high occurrence rate of stroke and the fact that it is a~     frequent cause of long-term disability in adulthood. Second because SDB (obstructive, central~     and mixed forms) affects more than 50% of stroke survivors and has a detrimental effect on~     clinical stroke outcome. Third, spontaneous and learning-dependent sleep-associated~     neuroplasticity may be affected by SDB following stroke worsening stroke rehabilitation.~     Therefore, it is crucial to investigate whether early treatment of SDB with Adaptive~     Servo-Ventilation (ASV), the treatment device of choice to treat obstructive, central and~     mixed forms of SDB, has a beneficial effect on the evolution of the lesion volume and on~     clinical stroke outcome.~      To this end, the investigators recruit and prospectively follow 3 groups of patients with~     ischemic stroke over 1 year. During the first night after hospital admission due to acute~     stroke, nocturnal breathing is assessed by means of a respiratory polygraphy. Patients with~     significant sleep disordered breathing, defined as an Apnea-Hypopnea-Index (AHI) > 20/h, are~     randomized to ASV treatment or no treatment (sSDB ASV+ or sSDB ASV-). ASV treatment starts~     the second night following hospital admission and ends 90 days later. Stroke patients without~     SDB (AHI < 5 / h) serve as a control group (no SDB) to observe the evolution of the lesion~     volume and stroke outcome without the additional burden of SDB.~      Lesion volume one day after hospital admission due to acute stroke (after potential lysis~     therapy) measured by Diffusion Weighted Imaging will be subtracted from lesion volume~     measured by T2-weighted volumetry assessed 90(+/-7) days following stroke and compared~     between patients with and without ASV treatment (sSDB ASV+ and sSDB ASV-) as well as patients~     without SDB (no SDB). Short- and long-term clinical stroke outcomes are assessed by clinical~     scales and questionnaires 4 to 7 days, 3 months and 1 year following stroke. Cognitive~     outcome is assessed during hospitalization (within the first week following stroke) and after~     the treatment period of 90 days by neuropsychological tests assessing attention and memory.~     In addition, baseline assessment of physiological parameters such as blood pressure and~     endothelial function/arterial stiffness are assessed during the first weeks following stroke~     and at the end of the treatment period, i.e. approximately 90 days following stroke.~   "
77354|NCT02554474|"~     Being physically active can reduce pain and fatigue, improve mobility and enhance quality of~     life in people with arthritis, but adherence to an active lifestyle is poor, with less than~     half of people with arthritis being active. The primary goal of this randomized controlled~     trial is to assess the efficacy of a physical activity coaching model to improve physical~     activity participation and reduce sedentary time in patients with Rheumatoid Arthritis and~     Systemic Lupus Erythematosus. This model combines the use of a Fitbit Flex (wireless physical~     activity tracker) paired with a FitViz application, a group education session, and telephone~     counselling by a physiotherapist.~   "
77355|NCT02554461|"~     On the basis of clinical and movement analysis records players are informed on what~     parameters can be optimized in order to improve their performance and avoid injuries~   "
77356|NCT02554448|"~     The purpose of this study is to evaluate the value of dynamic change in detecting CTCs in~     peripheral blood from stage III rectal cancer patients undergoing neoadjuvant Folfox~     treatment and chemoradiotherapy,before and after surgery.~   "
77357|NCT02554435|"~     Cardiovascular disease accounts for 1 in 3 deaths among US adults and is strongly related to~     physical activity. Most older adults do not participate in healthy levels of physical~     activity. Physical activity promotion and counseling from a primary health care provider is~     important for disease prevention. In addition to counseling, an activity monitor can increase~     physical activity through self-regulation. Two types of monitors are available: pedometers~     and electronic activity monitors (EAMs). Research shows that both monitors are motivational~     devices that can increase physical activity. Pedometers count steps of the wearer. EAMs can~     monitor steps, monitor burned calories, quality of sleep, and sedentary time. EAMs may also~     offer more behavioral change techniques and opportunities for self-monitoring. The goal of~     this study is to compare the effectiveness of EAMs compared to a pedometer on increasing~     physical activity and decreasing cardiovascular risk within older adult, primary care~     patients. The study will include sedentary, overweight primary care patients, 55-74 years of~     age with access to a smart phone or tablet. All participants will receive brief physical~     activity counseling. Participants will then be randomized to receive a self-monitoring device~     (Digi-walker CW-700/701 or UP24 by Jawbone) to wear for 3 months. Investigators will evaluate~     the following outcomes: physical activity, cardiovascular risk (Framingham risk calculator,~     fitness), psychological feeling toward exercise, physical function, health status, exercise~     motivation and self-regulation. The investigators hypothesize that EAMs will be more~     effective than pedometers in improving these outcomes. The results of this pilot test will~     aid in the translation of effective physical activity intervention components to primary care~     clinics for cardiovascular disease prevention.~   "
77358|NCT02554422|"~     Feasibility of the objective measurement of the ossicular chain mobility, by using a~     force-measuring device based on a fiber optics sensors (PalpEar).~   "
77359|NCT02554409|"~     The Sanofi Pasteur Fluzone Intradermal Quadrivalent vaccine (Fluzone QIV-ID) Pregnancy~     Registry will be a prospectively recruited pregnancy surveillance program designed to collect~     to collect and analyze information on vaccine exposures, pregnancy outcomes, and fetal and~     offspring outcomes on pregnant women exposed to Fluzone QIV-ID vaccine.~   "
77360|NCT02554396|"~     This is a one-day, randomized, double-masked, single-center evaluation of the efficacy and~     safety of PRX-100 ophthalmic solution compared to placebo in 20 subjects (randomized 4:1,~     PRX-100:placebo) to evaluate the safety of PRX-100 and the magnitude and duration of effects~     on improving near-vision acuity.~   "
77361|NCT02554383|"~     The objective of this trial is to determine whether certain subgroups of children with acute~     sinusitis exist in whom antibiotic therapy can be appropriately withheld.~   "
77362|NCT02554370|"~     Bilateral subthalamic deep-brain stimulation is a well-established therapeutic option to~     improve motor signs and reduce dopaminergic treatment and related motor complications in~     patients with severe forms of Parkinson's disease (PD). However, psychological disorders and~     socio-familial maladjustment are less clearly improved with subthalamic stimulation with an~     aggravation of the social adjustment described in about 1/3 of cases, with work disruption,~     divorce or familial conflict. The caregivers have also been reported to present negative~     well-being after surgery with an aggravation of the quality of life. In the present study,~     the investigators evaluate the effects of a perioperative psychoeducational programme to~     avoid postoperative socio-familial maladjustment in PD patients candidate for subthalamic~     stimulation, and their caregivers, in a randomized controlled study.~   "
77363|NCT02554357|"~     Shoulder arthroscopic causes post operative pain that outlasts analgesia provided by single~     injection nerve blocks.~   "
77364|NCT02554344|"~     The purpose of this study is to determine the safety, feasibility, and regression rate of~     using curcumin in patients with Cervical Intraepithelial neoplasias (CIN3). The secondary~     objectives of this study is to evaluate patients with CIN3 for the presence of high-risk~     Human papillomavirus (HPV) and to perform an inflammatory panel on dysplasia biopsies from~     patients with CIN3 to determine which factors play a role in persistence of CIN3.~   "
77380|NCT02554136|"~     The investigators investigate the potential pharmacokinetic drug-drug interaction between~     HGP0918 and HGP0816 in healthy adult subjects who receive HGP0918 alone, HGP0816 alone, and~     both together in a 3 period repeatedly~   "
77409|NCT02553759|"~     The aim of the present protocol is to prove if the observed actions (AOb) will improve the~     cervical range of motion (CROM) in patients with non-specific chronic neck pain (CNP). This~     study is a parallel-group double blind randomized clinical. Outcome measures were CROM, and~     pressure pain detection thresholds (PPDT) with a digital algometer. The follow-up will~     consist of three evaluations: pre- treatment, post-treatment and 10 minutes after second~     measurement (motor imagery).~   "
77365|NCT02554331|"~     Many people with idiopathic rapid eye movement (REM) sleep behavior disorder (RBD) have an~     underlying synucleinopathy, the most common of which are Parkinson's disease (PD) and Lewy~     body disease. Identifying additional abnormal clinical features may help in identifying those~     at greater risk of evolving to a more severe syndrome. Because gait disorders are common in~     the synucleinopathies, early abnormalities in gait in those with RBD could help in~     identifying those at increased risk of developing overt parkinsonism and/or cognitive~     impairment.~      The investigators aim to identify subtle gait abnormalities in idiopathic RBD and to identify~     sensitive and early biomarkers:~        1. to detect subtle gait disorders in pre-symptomatic stage of synucleinopathy and~        2. to track their evolution in the parallel with the disease progression.~      Main objective: In comparison with age and gender matched-controls, to identify in patients~     with RBD a larger reduction of gait velocity (and other abnormalities of spatio-temporal~     characteristics of gait) between a single (gait) and a dual-task (gait+cognitive task).~      Secondary objective:~        1. In comparison with age and gender matched-PD patients, to identify in patients with RBD~          a smaller reduction of gait velocity (and other abnormalities of spatio-temporal~          characteristics of gait) between a single (gait) and a dual-task (gait+cognitive task).~        2. In patients with RBD to identify correlations between the spatio-temporal~          characteristics modifications of gait between a single (gait) and a dual-task~          (gait+cognitive task) and the percentage of REM without atonia - the dopamine~          transporter (DAT) density using FP-CIT single-photon emission computed tomography; the~          reduction of the olfactory discrimination and thresholds.~        3. In patients with RBD to track the spatio-temporal characteristics evolution of gait over~          time (every 6 months for 2 years)~   "
77366|NCT02554318|"~     Tuberculosis (TB) patients often have a lower body mass index (BMI) and experience wasting.~     Wasting reduces lean body mass and may cause physical function impairment. This study aimed~     to determine the efficacy of fermented soybeans (tempeh) as a food supplement on body weight~     and physical function changes among active pulmonary tuberculosis patients with standard~     therapy.~   "
77367|NCT02554305|"~     This study compares between the clinical, hematological, inflammatory and neurological~     outcome of patients undergoing Coronary Artery Bypass Grafting (CABG) surgery in which~     different oxygenation systems will be used.~   "
77368|NCT02554292|"~     The main objective of the SeQuent® Please Neo post market surveillance is to assess the~     clinical suitability of the combination of pre-dilatation using the NSE Alpha scoring balloon~     before the use of the paclitaxel-coated SeQuent® Please Neo in an 'all comer'/ 'real world'~     setting for the treatment of in-stent restenosis.~   "
77369|NCT02554279|"~     The purpose of this trial is to demonstrate non-inferiority of MENOPUR® versus recombinant~     Follicle Stimulating Hormone (rFSH) (Gonal-f®) with respect to ongoing pregnancy rate in~     women undergoing controlled ovarian stimulation (COS) following GnRH treatment.~   "
77370|NCT02554266|"~     The study will enroll patients presenting with claudication, or critical limb ischemia~     (Rutherford Category 3- 5) and an angiographically significant (≥ 70%) native artery lesion~     appropriate for angioplasty that is below the knee. Subjects will be treated with the Lutonix~     Drug Coated Balloon (DCB) carrying the CE Mark per current IFU and followed clinically for a~     minimum of 2 years.~   "
77371|NCT02554253|"~     Ketamine is a commonly used anesthetic medication which is used for induction of anesthesia~     as well as as an analgesic. It has been shown to have anti-inflammatory properties which may~     decrease post-operative complications following cardiac surgery with cardiopulmonary bypass~     that are thought to associated with inflammation. Some studies have shown that ketamine does~     decrease these complications when compared with anesthetics that are not commonly used in our~     cardiac anesthesiology practice. Propofol is another commonly used anesthetic medication~     which is used for induction of anesthesia. Ketamine has not been compared with propofol for~     potential to reduce post-operative complications associated with the inflammatory process.~     This study aims to see if ketamine will reduce the incidence of cognitive dysfunction,~     delirium, and renal dysfunction in comparison with propofol. In addition, the hemodynamic~     impact of ketamine compared propofol will be investigated.~   "
77372|NCT02554240|"~     This Phase II clinical study is to evaluate the efficacy and safety of DA-5202 in patients~     with osteoarthritis of the knee.~   "
77373|NCT02554227|"~     Spondylodiscitis is an infectious disease of the intervertebral discs and adjacent vertebral~     bodies, which often has a protracted progression. Diagnosis is frequently delayed because of~     the unspecific pathology and a lack of specific infection markers. However, an early~     diagnosis is fundamental to prevent long periods with symptoms including extensive back pain~     and progressive and destructive changes of the spine.~      Cytokines can be helpful to extend the knowledge about diverse biological processes.~     Furthermore, they are a promising category of biomarkers that are already present in the~     early phases of developing diseases. Currently, little is known about the participation of~     cytokines in Spondylodiscitis. The aim of this study is to establish a non-invasive method to~     improve the diagnosis of spondylodiscitis. Therefore, blood and tissue samples will be~     analyzed at different time points for the concentration of specific cytokines to select~     potential marker cytokines via a Multiplex Assay. After successful identification of marker~     cytokines, verification of the results will be done by expression analysis of~     cytokine-producing cells.~      The potential of such a diagnostic method lies in reducing medical costs and preventing~     extensive pain and structural changes of the spine.~      Experimental research will be performed with the approval of the ethic committee of the~     medical faculty of the University of Cologne.~   "
77374|NCT02554214|"~     This will be a prospective, descriptive, mono-center, non-comparative study. A sample of 30~     patients who satisfy entry criteria is estimated to be appropriate to provide safety and~     performance data for this study.~      The objectives of the study are to verify the performance and safety of the Glafkos~     adjustable glaucoma drainage device system. Performance will be measured assessing the~     possibility to adjust the intra-ocular pressure post-operatively. Safety will be measured by~     the incidence and severity of adverse events.~      The Glafkos device will be implanted in combination with a seton tube. The implant is placed~     under a scleral flap, in a manner analogous to the ex-Press device (Alcon). The distal end of~     the draining tube is linked to a seton draining tube, which is linked to a plate placed under~     the extraocular muscles, creating a filtering space at the orbit (filtering bleb).~   "
77375|NCT02554201|"~     The main goal to treat early NLUTS is to relieve lower urinary tract syndrome and prevent~     from late complications. The present study is to evaluate the efficacy of electrical pudendal~     nerve stimulation (EPNS) and transanal/transvaginal electrical stimulation (TES) in NLUTD.The~     study design consists of a non-randomized, parallel controlled trial. A total of 60 eligible~     patients will be involved and divided into EPNS or TES group according to their location of~     medical treatment. The primary endpoint is lower urinary tract syndromes (ICIQ-FLUTS/MLUTS).~     The second endpoint is assessment of daily life Qol (ICIQ-LUTSqol), and residual urine~     volume.~   "
77376|NCT02554188|"~     The objective of this study is to test a Fasting-Mimicking Diet (FMD) for its efficacy on~     improving immune response to flu vaccination in an older adult population (50-75 years of~     age).~   "
77381|NCT02554123|"~     A prospective ranfomized clinical study of patients undergoing Milligan Morgan´s~     haemorrhoidectomy at Hospital Universitario Rey Juan Carlos (Móstoles-Spain) will be~     performed. The patients will be randomized into 2 groups:~        -  Experimental group (EG): Patients undergoing Milligan Morgan´s procedure and application~          of Vitamin E ointment on the surgical bed.~        -  Control group (CG): Patients undergoing Milligan Morgan´s procedure and application of~          Vaseline on the surgical bed.~      Postoperative pain determined by VAS at the 1st, 3rd and 7th postoperative days, and need for~     morphine rescue will be investigated.~   "
77382|NCT02554110|"~     This study is designed to determine if using peripheral nerve stimulation in conjunction with~     pulse oximetry as an adjunct to traditional monitoring in the PACU reduces the frequency and~     severity of sedation related apnea and hypoxic events.~   "
77383|NCT02554097|"~     Patients with gallstone and confirmed common bile duct stones are registered in this study.~     The three managements for common bile duct stones are endoscopic sphincterotomy (EST),~     laparoscopic common bile duct exploration (LCBDE) and laparoscopic transcystic common bile~     duct exploration (LTCBDE). Patients will be assessed at baseline, preoperative~     investigations, operative method, operative time, conversion to open procedure,~     intraoperative and postoperative complications, and the presence of retained and recurrent~     stones. All patients were followed up for 3 years by telephone interview ang outpatient~     visits. Abdominal US and liver function tests were carried out whenever any abdominal symptom~     appeared during the follow-up period. If there were unusual findings, magnetic resonance~     cholangiopancreatography(MRCP) was carried out.~   "
77384|NCT02554084|"~     The purpose of this study is to evaluate a new instrument that takes digital images of tear~     film (a thin film that coats the eye that is made up of oil and water). The investigators are~     interested in measuring how the thickness of the tear film varies through time. The goal is~     to develop a technique that may enable non-invasive evaluation of Dry Eye Disease for future~     clinical diagnosis.~   "
77385|NCT02554071|"~     A single arm pilot study conducted to assess the feasibility of having Manitoba Pharmacists~     provide support (product and cognitive) to low-income (receiving social assistance) smokers~     wishing to quit smoking.~   "
77386|NCT02554058|"~     A novel rehabilitation bike has been developed for patients with incomplete spinal cord~     injuries that incorporates mechanical stimulators on the bike pedals to stimulate the sensory~     receptors in the soles of the feet; the effect of mechanical stimulator on muscle~     strengthening has been reported by NASA to improve muscle atrophy in astronauts in~     zero-gravity environments. Cycling also stimulates lower limb position sensors. We predict~     that the combination of mechanical stimulation with cycling may be similar enough to walking~     over ground to lead to gains in balance and mobility. The present study will evaluate the~     therapeutic effect of this bike on balance, walking, as well as cortical-spinal and spinal~     pathways in patients with incomplete spinal cord injuries.~   "
77387|NCT02554045|"~     Data confirming a role for PDE5 in adipocyte biology in vitro have been recently reported.~     However, a better understanding of the complex role of PDE5 in fat metabolism and whole body~     homeostasis requires the use of transgenic animal models either lacking or overexpressing~     PDE5 in adipose tissue. This will clarify the role of PDE5 in adipose expansion and~     metabolism, and also in glucose homeostasis and vascular function in vivo. Analysis of~     expression and activity of PDE5 in different sites of human adipose tissue (i.e. visceral vs.~     subcutaneous), and also in different metabolic conditions (i.e. high-fat diet vs. low calorie~     intake) could reveal if PDE5 can be considered to be a reliable 'marker' of metabolic~     dysfunction of the adipocyte. Importantly, chronic treatment with the PDE5 inhibitor~     sildenafil in a mouse model of diet-induced insulin resistance caused a significant~     improvement in insulin sensitivity . Also, in humans chronic exposure to tadalafil confirmed~     an improvement of insulin sensitivity in men with erectile dysfunction. However, the efficacy~     of long-term treatment with PDE5i awaits demonstration in human metabolic diseases such as~     obesity and insulin resistance.~      The primary purpose of the study is to investigate the effects of tadalafil taken once a day~     on body composition in men with sexual distress and/or erectile dysfunction.~   "
77388|NCT02554032|"~     The ACE trial is a multicentre, randomized controlled trial comparing axillary vs. innominate~     artery cannulation for established antegrade cerebral perfusion in patients having aortic~     surgery (thoracic and aortic arch) requiring deep hypothermic circulatory arrest using a~     non-inferiority trial design.~   "
77389|NCT02554019|"~     The purpose of this study is to evaluate the safety and efficacy of repeated intravenous~     infusions of the study drug BT063 in patients with Systemic Lupus Erythematosus (SLE)~     compared with people who receive a placebo.~   "
77390|NCT02554006|"~     A single-center, randomized trial of admitted patients with ischemic heart disease receiving~     percutaneous coronary intervention and stent implantation will be conducted at University~     Hospital of Ferrara. Patients will be randomized to either the control (standard care) or the~     bundle group in which patients will receive counseling regarding dual antiplatelet therapy~     management, advantages and side effects, screening for depression or anxiety, standardized~     education. The primary endpoint will be the difference in the quality of life as assessed by~     EQ-5D questionnaire.~   "
77391|NCT02553993|"~     The objective of this study was to: compare the training and maintenance effects of 3 balance~     training programs (2 kinds of exergame systems and 1 conventional weight-shifting training~     program) on cognitive function of subjects with chronic stroke.~   "
77392|NCT02553980|"~     Practicing a habitual physical activity is important for health. A Virtual Trainer (VT)~     online system was developed in 2006 (1st version) and improved in 2010 (2nd version) for~     encouraging an active lifestyle. This project intends to further improve the VT (3rd version)~     which incorporates more effective psychological and e-health theories, and disseminate it to~     Hong Kong middle-aged adults.~   "
77393|NCT02553967|"~     Breast reconstruction is an integral part of the management of patients with breast cancer~     and treated by total mastectomy. The aim of breast reconstruction is to get a satisfying~     aesthetic and functional result (sensitivity) and that would enable the patient to~     appropriate the reconstructed breast. Patient satisfaction assessed subjectively by~     questionnaires would be better in autologous reconstructions than in reconstructions by~     prosthesis.~      The aim of our trial is to use functional MRI (fMRI) as an objective evaluation tool to~     describe the brain functional changes of sensory projections after immediate or secondary~     breast reconstruction.~   "
77394|NCT02553954|"~     Epidemiological data show that the incidence of carcinoma, the most common cancer, is~     strongly linked to the age. Non Melanoma Skin Carcinomas (NMSCs) (the most frequent cancers~     in the elderly population) derive from keratinocytes of the basal layer of the epidermis,~     from differentiated keratinocytes of the more superficial layers or from stem cells of hair~     follicles. Unlike NMSCs, soft-tissue sarcomas, including those deriving from dermal~     fibroblasts, are very rare (less than 1% of all cancers). Our overall purpose is to decipher~     the molecular pathways activated during the aging of these tissues that may explain why they~     have a so different propensity to undergo a malignant transformation. Given that senescent~     cells accumulate in the dermis and epidermis with age, we will constitute two groups : young~     skin that we arbitrarily limit to the range ≥ 18 and ≤ 40 and aged skin ≥ 55.~      Thus the main objective of our study is to search within 2 age groups (≥ 18 and ≤ 40 years~     and ≥ 55 years) the expression of senescence markers on healthy skin tissue.~   "
77395|NCT02553941|"~     This phase Ib trial studies the side effects and best dose of ibrutinib when given together~     with azacitidine in treating patients with myelodysplastic syndrome that is likely to occur~     or spread (higher risk) and who were previously treated or untreated and unfit for or refused~     intense therapy. Ibrutinib and azacitidine may stop the growth of cancer cells by blocking~     some of the enzymes needed for cell growth.~   "
77396|NCT02553928|"~     Evaluation of the safety and tolerability of a 20 mg once daily dose of memantine compared~     with 10 mg given twice daily in patients with dementia of Alzheimer's type and MMSE range~     5-18.~   "
77397|NCT02553915|"~     This project aims to evaluate whether a dose-response relationship exists between dose of~     polyunsaturated fatty acids (PUFA), delivered as eicosapentaenoic acid (EPA), and change in~     markers of inflammation, and whether these effects differ from placebo. A key secondary aim~     is to evaluate the antidepressant effectiveness of EPA in overweight adult outpatients with~     current major depressive disorder (MDD). To address these aims, the project will use a~     four-arm, randomized, parallel-group, placebo-controlled design comparing placebo versus~     three doses of EPA (1 gm/day, 2 gm/day, or 4 gm/day) administered over 12 weeks. The study is~     to be conducted at two sites: Emory University School of Medicine, and Massachusetts General~     Hospital. Eligible participants will be between the ages of 18-80 who have current MDD, are~     overweight, and who demonstrate peripheral inflammation, defined as an high sensitivity~     C-reactive protein (hs-CRP) level ≥ 3 mg/L. The primary outcome will be change in plasma~     interleukin-6 (IL-6) levels and/or mitogen-stimulated peripheral blood mononuclear cells~     (PBMC) Tumor Necrosis Factor-alpha (TNF-α) expression levels in EPA- versus placebo-treated~     participants. The results of this investigation are intended to be used to design and power a~     larger definitive test of the efficacy and biological effects of EPA in patients with major~     depressive disorder.~   "
77398|NCT02553902|"~     OBJECTIVES:~      To evaluate the effect and cost-utility of a combination therapy of SPT+MAD compared with~     continuous positive airway pressure (CPAP) in patients with moderate positional obstructive~     sleep apnea (POSA).~      HYPOTHESIS:~      The SPT+MAD combination is more cost-effective and effective, in means of reduction of the~     apnea-hypopnea index (AHI), quality of life and compliance, compared with CPAP.~      STUDY DESIGN:~      A multicenter randomized clinical trial (RCT) will be performed with a follow-up of 12 months~     per patient. Patients will be randomized for CPAP or the combination SPT and MRA. All~     outcomes will be measured at baseline, month 3, 6 and 12.~      STUDY POPULATION:~      Patients diagnosed with moderate POSA according to polysomnography (PSG) results.~      INTERVENTION / STANDARD INTERVENTION TO BE COMPARED TO:~      The SPT trains POSA patients to sleep in non-supine positions, CPAP uses positive airway~     pressure to open the airway; MRA is an intra-oral prosthesis, which holds the mandible in a~     protrusive position, all to prevent effectively apneic events.~      OUTCOME MEASURES:~      AHI, compliance, quality-adjusted life year (QALY), direct and indirect costs, cardiovascular~     parameters, incremental cost-effectiveness ratio (ICER)~      SAMPLE SIZE / DATA ANALYSIS:~      100 subjects in each treatment group, total of 200 patients.~      COST-EFFECTIVENESS ANALYSIS / BUDGET IMPACT ANALYSIS:~      The SPT is expected to improve the cost-effectiveness of overall treatment of POSA patients,~     and will save annually approximately 35-150 million euros.~   "
77399|NCT02553889|"~     Evaluation of safety, tolerability, PK and PD of ISIS 416858 in patients with end-stage renal~     disease (ESRD) receiving chronic hemodialysis.~   "
77400|NCT02553876|"~     There are no studies as yet specifically investigating the application of DRG stimulation in~     the treatment of chronic pain affecting the upper limbs. The investigators propose to~     investigate the effect of dorsal root stimulation in patients with chrionic hand or upper~     limb pain.~   "
77401|NCT02553863|"~     The purpose of this study is to determine whether a course of acupuncture is effective in the~     management of peripheral neuropathy related pain in patients receiving chemotherapy.~   "
77402|NCT02553850|"~     This open non-randomized, single-arm, multicenter, observational study is designed to~     evaluate the correlation between bone turnover markers and the response to treatment in~     patients with breast cancer and bone metastases. In this observational study, ibandronate~     (Bondronat) will be prescribed and used in accordance with the standards of care. Data will~     be collected for 12 months.~   "
77403|NCT02553837|"~     This study was aimed to evaluate the Immunogenicity and Safety response by vaccinating~     Hantavax in Healthy Adult.~   "
77404|NCT02553824|"~     This study will demonstrate the efficacy of Qsymia versus placebo in treating bulimia nervosa~     and binge eating disorder.~   "
77405|NCT02553811|"~     There is no golden universal standard for the diagnosis of Carpal Tunnel Syndrome (CTS). In~     this scenario, for a comparison of the effectiveness of the principal diagnostic tests CTS~     should determine how they affect the likelihood of disease through a clinical accuracy trial~     of good methodological quality in order to get answers to what is the best diagnostic~     strategy in clinical CTS practice. The paresthesia in nerve distribution territory median~     hands is the most common symptom in patients with CTS. The nuisance caused by paresthesia~     directly affects the quality of life of patients and impairs daily manual activities and~     sleep quality. To evaluate the remission of paresthesia is a major clinical criterion for~     improved STC being an expected relevant outcome for the patient. This study evaluated and~     compared the diagnostic accuracy of the ultrasonography (US) and electromyography (EMG),~     considering the postoperative status of remission of paresthesia as the reference standard in~     the diagnosis of CTS.~   "
77410|NCT02553746|"~     The patients will be allocated to 2 groups: the ultrasound group and the palpation group.~     Ultrasound detection of the puncture site will be performed to the patients of the one group~     (group U). The puncture site will be determined by palpation of the landmarks at the patients~     of the other group (group L). The main purpose of the study is to determine if the ultrasound~     scan of the lumbar spine can facilitate spinal, epidural and combined spinal-epidural~     anesthesia, increase the success and decrease the complication rate of these techniques. The~     secondary purpose of the study is to evaluate if the lumbar ultrasound scan can be used to~     determine accurately the depth of the epidural space.~   "
77411|NCT02553733|"~     In this study the investigators will test the hypothesis that short-term consumption of~     inorganic nitrate (supplied in concentrated beetroot juice) enhances coronary blood flow~     responses, large artery hemodynamics, and leg oxygenation/exercise tolerance in patients with~     peripheral arterial disease (PAD). Understanding and improving blood flow regulation in the~     heart and skeletal muscles of patients with PAD is important because exercise triggers~     symptoms of leg pain and substantially raises blood pressure and myocardial demand in these~     patients.~   "
77412|NCT02553720|"~     The purpose of this study is to test whether addition of aquatic exercise to conventional~     treatment helps reduce the adverse outcomes of deep vein thrombosis and reduce the severity~     of chronic venous insufficiency.~   "
77413|NCT02553707|"~     This study will assess the short term efficacy of ibandronate (6 mg intravenous [IV]) in~     participants with breast cancer and malignant bone disease, with moderate to severe pain. All~     participants will receive an IV infusion of ibandronate on Days 1, 2, and 3, and pain~     response will be measured on Days 1-7. The anticipated time on study treatment is 3 days, and~     the target sample size is 182 individuals.~   "
77414|NCT02553694|"~     The purpose of this study is to determine how satisfied patients are when undergoing an~     overnight polysomnogram (sleep study), what their knowledge about sleep apnea is, and what~     factors affect obstructive sleep apnea (OSA) treatment use.~   "
77415|NCT02553681|"~     This will be an up to six months, subject-masked, contralateral, parallel-group, randomised,~     daily wear study. All subjects will wear the Test lens in one eye and the Control lens in the~     other eye. Data from the first four weeks of Test and Control lens exposure will be used for~     the FDA 510 (k) submission.~   "
77416|NCT02553668|"~     Aim of the present study is to investigate the influence of hyperoxia on the protein~     expression using the differential analysis of protein expression in tissues (proteomics). In~     the study, blood and urine samples will be collected from participants who undergo a short~     term hyperoxia using 100% oxgen for 3 hours.~      Here, gel electrophoresis, protein separation and mass spectroscopy allow to identify~     affected proteins. Based on these results, different induction factors of proteins will be~     determined and then assessed using a bioinformatic network analysis regarding the cellular~     influence.~   "
77417|NCT02553655|"~     The investigators would like to determine if remote ischemic leg preconditioning in healthy~     volunteers improves cerebral vasomotor reactivity as measured by breath holding and~     transcranial doppler vasomotor reactivity.~   "
77418|NCT02553642|"~     The purpose of this study is to investigate the characteristics of tumors in patients treated~     with nivolumab and to identify features that help to predict a good or bad response to this~     drug.~   "
77419|NCT02553629|"~     This is a randomized control trial (RCT) that studies the surgical conditions during moderate~     and deep neuromuscular blockade in 100 morbidly obese patients receiving elective~     laparoscopic surgery for bariatric surgery.~   "
77420|NCT02553616|"~     Investigators will use a Solomon 4-group design to test the effectiveness of a brief~     intervention to promote health behaviors for homeless youth who are 18-23 years of age. We~     will recruit 300 youths from Austin, TX and 300 from Columbus, OH. We will gather~     quantitative data on health behaviors and life satisfaction 3 and 6 months following the~     intervention, which will be delivered on an individual basis. Data will be analyzed using~     structural equation modeling and ANCOVA statistics.~   "
77421|NCT02553603|"~     This study is examining the effects of growth hormone releasing hormone (GHRH) on mild~     cognitive impairment (MCI). GHRH will be given at a dose of 1mg/day for 10 weeks to subjects~     with MCI as well as healthy controls.~   "
77422|NCT02553590|"~     To expand knowledge on the application and tolerability of immunotherapy with LAIS® 2-tree~     allergoid tablets as well as knowledge on the alleviation of symptoms during sublingual~     therapy in special consideration of the chosen titration schedule in everyday practice.~   "
77423|NCT02553577|"~     There has been a dramatic escalation of electronic cigarette (e-cig) use among women of~     childbearing age, including pregnant women. The overall goal of this study is to determine~     the effects of e-cigs on prenatal biomarkers and birth outcomes. It is imperative that more~     data about these effects be available to better inform women of childbearing age.~   "
77424|NCT02553564|"~     After a hospitalization, dialysis patients have a high risk of being admitted to the hospital~     again within 30 days. The purpose of this research study is to test a new way of reducing the~     chance of patients being hospitalized again. In this study investigator will evaluate a~     checklist driven evaluation upon return to the dialysis facility as a method to reduce the~     rate of rehospitalizations in hemodialysis patients.~   "
77425|NCT02553551|"~     The aim of this study is to evaluate the effect of Vitamine C supplements to be helpful to~     reduce the postoperative pain after laparoscopic cholecystectomy through the double-blinded~     randomized controlled trial.~   "
77426|NCT02553538|"~     Patient navigation (PN) has been shown to improve rates of cancer screening in vulnerable~     populations. Most cancer PN programs are located in community health centers and focus on a~     single cancer. The investigators will evaluate the impact of PN program on breast, cervical,~     and/or colorectal cancer screening in vulnerable patients receiving care in a large,~     academic, primary care network using a population-based IT system.~   "
77454|NCT02553161|"~     A 16-week double blind, placebo-controlled investigation of escitalopram in adolescents with~     depression and/or anxiety with a family history of Bipolar Disorder. Subjects will be~     evaluated using semi-structured diagnostic interviews and symptom ratings, participate in a~     MRI scan and then randomized to treatment. Following randomization, high-risk youth will have~     visits every week for the first 4 weeks of treatment then biweekly up to 16 weeks during~     which time tolerability and ratings will be performed. MRI scan will be repeated at week 4.~   "
77427|NCT02553525|"~     The purpose of this study is to measure the effects of non-regular temporal patterns of deep~     brain stimulation (DBS) on motor symptoms and neural activity in persons with Parkinson's~     disease (PD), essential tremor (ET) or multiple sclerosis (MS). These data will guide the~     design of novel stimulation patterns that may lead to more effective and reliable treatment~     with DBS. These data will also enable evaluation of current hypotheses on the mechanisms of~     action of DBS. Improving our understanding of the mechanisms of action of DBS may lead to~     full development of DBS as a treatment for Parkinson's disease and may lead to future~     applications of DBS.~   "
77428|NCT02553512|"~     The purpose of this study is to demonstrate the use of a digital health offering in the~     management of persistent hypertension during chronic anti-hypertensive treatment.~   "
77429|NCT02553499|"~     In this study, participants with advanced solid tumors will be assigned to receive either~     MK-1248 alone or in combination with pembrolizumab (MK-3475). This study will use an adaptive~     design to find and confirm the maximum tolerated dose (MTD, or maximum administered dose~     [MAD]) for MK-1248 alone and in combination with pembrolizumab.~      Enrollment into this study has been prematurely discontinued due to program prioritization~     and not related to any safety concerns.~   "
77430|NCT02553486|"~     This study evaluates the global quality of life of foreign born adopted children, one to~     seven years following their arrival in France. Investigators will assess global health,~     behavior, school integration for each child who arrived in France between 2008 and 2013,~     through an online anonymous survey. Investigators, then, will identify variables associated~     with a lower quality of life in order to improve the support offered to the children.~   "
77431|NCT02553473|"~     Comparison of Doxycycline 200 mg once daily for six weeks versus Doxycycline 200 mg once~     daily for two weeks + placebo for four weeks. Primary objective is to answer the question is~     two weeks doxycycline treatment (currently suggested treatment) at least as effective as six~     weeks doxycycline treatment in Lyme Neuroborreliosis?.Key secondary objectives are to~     provide a better understanding of the pathogenesis and long‐term complaints, and to search~     for new biomarkers in Lyme Neuroborreliosis (LNB) by collecting clinical data, blood, and~     cerebrospinal fluid (CSF) in a biobank for future research~      Endpoints:~      Primary endpoint: Improvement on a composite clinical score from inclusion to six months~     after ended treatment defined as clinical score at inclusion minus clinical score at six~     months.~      Secondary endpoints: Improvment on a composite clinical score 12 months after ended~     treatment. Fatigue Severity Scale (FSS),Patient Health Questionnaire (PHQ-15), Short Form 36~     (SF-36) and blood and CSF findings at inclusion, after 6 and 12 months.~      The study design is a multicenter, non-inferiority, randomized, penta-blind,~     placebo-controlled trial. 120 patients will be included from Sørlandet Hospital and 5-10~     other Norwegian hospitals.~      Main inclusion criteria are neurological symptoms suggestive of LNB without other obvious~     reasons, one or both of a) Cerebrospinal fluid pleocytosis (>5 leukocytes/mm3) b) intrathecal~     Bb antibody Production and signed informed consent. Safety assessments during the trial:~     Comparison of clinical outcome six months after end of treatment between the two treatment~     groups. Subjective experiences and blood tests including hematology and biochemistry for four~     weeks after ended treatment.~   "
77432|NCT02553460|"~     The purpose of this study is to test the good and bad effects of the study drugs bortezomib~     and vorinostat when they are given in combination with chemotherapy commonly used to treat~     acute lymphoblastic leukemia (ALL) in infants. For example, adding these drugs could decrease~     the number of leukemia cells, but it could also cause additional side effects. Bortezomib and~     vorinostat have been approved by the US Food and Drug Administration (FDA) to treat other~     cancers in adults, but they have not been approved for treating children with leukemia. With~     this research, we plan to meet the following goals:~      PRIMARY OBJECTIVE:~        -  Determine the tolerability of incorporating bortezomib and vorinostat into an ALL~          chemotherapy backbone for newly diagnosed infants with ALL.~      SECONDARY OBJECTIVES:~        -  Estimate the event-free survival and overall survival of infants with ALL who are~          treated with bortezomib and vorinostat in combination with an ALL chemotherapy backbone.~        -  Measure minimal residual disease (MRD) positivity using both flow cytometry and PCR.~        -  Compare end of induction, end of consolidation, and end of reinduction MRD levels to~          Interfant99 (ClinicalTrials.gov registration ID number NCT00015873) participant~          outcomes.~   "
77433|NCT02553447|"~     This randomized pilot early phase I trial studies how well cholecalciferol works in treating~     patients with newly diagnosed non-Hodgkin lymphoma or chronic lymphocytic leukemia with low~     levels of vitamin D (vitamin D deficiency). Cholecalciferol may increase levels of vitamin D~     and improve survival in patients with non-Hodgkin lymphoma or chronic lymphocytic leukemia~     receiving standard of care chemotherapy.~   "
77434|NCT02553434|"~     After sustaining severe trauma to the chest, patients will often bleed into the chest cavity~     pleural space) which is called hemothorax or they may also experience air leakage within the~     chest cavity in combination with the bleeding (hemopneumothorax). The treatment for these~     conditions include the insertion of a tube into the chest called a chest tube). Insertion of~     the chest tube is commonly very painful for the patient due to the size or diameter of the~     tube. Alternatively, procedure it is standard practice in the acute care setting at~     Banner-University of Arizona Tucson Campus (B-UATC) to insert a pigtail catheter, which has a~     smaller diameter, into the chest wall to treat the hemothorax or hemopnuemothorax. The~     primary purpose of this study is to see if the use of the pigtail catheter is just as~     effective as chest tube insertion in terms of removing leaked blood and/or air from the chest~     cavity. An additional objective of this study is to evaluate which procedure is less painful~     for the patient.~   "
77435|NCT02553421|"~     This study will examine the use of the ivWatch Model 400 to monitor PIV sites in pediatric~     patients. Half the participants will be monitored by the device without infiltration~     notifications and the other half will be monitored by the device with infiltration~     notifications enabled.~   "
77455|NCT02553148|"~     A cross-sectional analysis of prevalence data from a stratified sample of 23 countries used~     to estimate the global need for palliative care for children aged 0-19 years. Prevalence~     data, from the Institute for Health Metrics and Evaluation, was for 12 major diagnostic~     groups needing children's palliative care according to WHO and UNICEF guidelines.~   "
77436|NCT02553408|"~     Putting the limited use of titration algorithms in the context of escalating diabetes~     prevalence rates, strategies and tools are urgently needed to help both patients and primary~     care providers efficiently initiate and continue basal insulin therapy. Basel insulin is~     considered to be the appropriate strategy after oral diabetic agent failure. This project~     could set the stage for the need for a blood glucose meter with built-in algorithms designed~     to support decision making by patients as well as care providers. Furthermore, the project~     will evaluate the uptake and use of the newly developed Meter by Abbott Diabetes Care, which~     was launched in Canada in October 2014, and its impact on primary care diabetes consultation.~   "
77437|NCT02553382|"~     Despite the availability of multiple medications for the treatment of Type 2 diabetes,~     patients often continue to have difficulty attaining blood glucose targets and managing~     cardiovascular disease risk factors. Recent trends in non-pharmacological therapy have~     created a growing public interest in dietary supplements.~      Research by this group and others support the benefits of whole grains, viscous dietary fibre~     and ginseng in the management of diabetes. The current study investigates whether the~     co-administration of a viscous dietary fibre blend, Salba (a grain rich in omega-3 fatty~     acids), and 2 varieties of ginseng roots will further improve blood sugar control and~     cardiovascular disease risk outcomes in individuals with Type 2 diabetes already receiving~     conventional treatments.~      Patients with Type 2 diabetes receiving the recommended intervention in accordance with the~     Canadian Diabetes Association guidelines will be enrolled in a 6-month clinical study. Half~     of the participants will be randomly assigned to a 4-component intervention that comprises~     the co-administration of these four dietary/herbal supplements in addition to their usual~     treatment regimen; the other half will continue their usual treatment regimen in addition to~     taking high-oat fiber and wheat bran supplements.~      The investigators hypothesize that an intensified, multi-targeted intervention with the~     addition of these dietary and herb components will further improve long-term blood glucose~     control and cardiovascular disease risk factors beyond conventional therapy. If this~     combination of viscous fiber, Salba and ginseng is shown to be beneficial, these remedies~     could complement current conventional therapy for Type 2 diabetes with the goal to further~     improve health outcomes.~   "
77438|NCT02553369|"~     Late 2013, the first indigenous cases of chikungunya have been observed in the French~     Antilles. At the end of May 2014, almost all of the islands of the Caribbean were affected by~     the outbreak.~      During the large epidemic which affected the Island of La Réunion in 2005/2006, the attack~     rate was 38%. The most active period was three months.~      In this context, knowledge of the attack rate and the epidemic in the Caribbean is an~     important issue for outbreak management and modeling work.~      As the chikungunya virus had never circulated in the Caribbean, determining the~     seroconversion rate can be achieved by realizing a seroprevalence survey among the general~     population at the end of the outbreak. Another simple method is to estimate the rate in a~     cohort of patients followed regularly and whose habitat is distributed throughout the~     territory studied.~      The follow up of patients infected by the human immunodeficiency virus (HIV) in the French~     West Indies is almost exclusively performed in hospitals in department of Infectious and~     Tropical Diseases.The high prevalence of HIV and homogeneous distribution of infected~     patients on all of our territories, allow to hypothesize that the risk of transmission of~     arboviruses by exposure to mosquito bites is comparable to the general population. This~     patient cohort is well suited to study the emergence of Chikungunya in the French West Indie~     .~      Primary objective :~      To estimate the cumulative incidence at the end of the first Chikungunya outbreak in the~     French West Indies by estimating the prevalence of specific antibodies of chikungunya virus~     in a sample (randomly constituted) from patients infected by HIV and representative of the~     general population of Martinique and Guadeloupe~      Secondary objective :~      To estimate the frequency of asymptomatic infections by the chikungunya virus in the studied~     population To estimate the frequency of chronic forms of chikungunya in the studied~     population~   "
77439|NCT02553356|"~     This Phase 1, single-dose study will be conducted in adult female subjects (N = 16) who are~     in general good health and selected for participation in the study according to the selection~     criteria. This study will assess the effect of food on the pharmacokinetics of PT2385~     Tablets. The study will consist of two periods and will be conducted in a crossover fashion.~   "
77440|NCT02553343|"~     The aim of the study is to assess the safety and immunogenicity of two formulations of the~     high-dose quadrivalent influenza vaccine compared to the licensed high-dose trivalent~     influenza vaccine control in healthy elderly subjects aged 65 years of age and above.~      Primary objectives:~        -  To describe the safety profile of all subjects in each study group.~        -  To demonstrate that the high-dose quadrivalent influenza vaccine induces an immune~          response (as assessed by HAI geometric mean titers (GMTs) that is non-inferior to~          responses induced by the licensed high-dose trivalent influenza vaccine for the 3 common~          virus strains at 28 days post-vaccination.~      Secondary objectives:~        -  To describe post-vaccination immunogenicity for the 4 virus strains (as assessed by~          seroconversion and seroprotection) for subjects who receive the high-dose quadrivalent~          influenza vaccine and the licensed high-dose trivalent influenza vaccine.~        -  To describe post-vaccination immunogenicity for the 4 virus strains (as assessed by~          GMTs, seroconversion, and seroprotection) for subjects who receive the high-dose~          quadrivalent influenza vaccine and the investigational high-dose trivalent influenza~          vaccine.~   "
77441|NCT02553330|"~     A phase 2 study to find out if the drug INCB018424 Phosphate Cream is safe and has beneficial~     effects in people who have alopecia areata (partial or complete hair loss) when applied to~     the skin.~   "
77442|NCT02553317|"~     The study is a phase III, double blind, placebo-controlled, randomized study to evaluate the~     efficacy and safety of caplacizumab in more rapidly restoring normal platelet counts as~     measure of prevention of further microvascular thrombosis~   "
77456|NCT02553135|"~     Phase II gene therapy study, involving a total of 6 male patients with choroideremia. The~     study will be conducted at the Bascom Palmer Eye Institute, University of Miami. Patients~     will be required to attend a total of 11 study visits over a 24 month period with an~     additional 3 year follow-up.~   "
77457|NCT02553122|"~     Total knee arthroplasty is a surgical procedure that involves a significant amount of blood~     loss and it has always been the surgeons' goal to try to minimize blood loss. In the current~     study, we will investigate the effect of blood loss after total knee arthroplasty with the~     combination of Evicel, a fibrin sealant and Tranexamic Acid.~   "
77458|NCT02553109|"~     The optimal consensus concerning treatment of incidental small paraclinoid unruptured~     intracranial aneurysms (UIAs) remains controversial. The aim of this prospective study is to~     reveal the natural history of small paraclinoid UIAs with the goal of informing the treatment~     plan.~   "
77459|NCT02553096|"~     Aim is to test the effect of ACCESS (Adaptive Computerized COPD Exacerbation Self-management~     Support), a software application designed to support patients with COPD in self-management~     of exacerbations.~   "
77443|NCT02553304|"~     Chronic lymphocytic leukemia (CLL) is the most common leukemia in adults in Western~     countries; it is stratified as a subtype of indolent lymphoid malignancy with a long but~     slowly progressive nature history. However, the clinical course of CLL actually varies~     widely. Thus, many clinical and molecular features have been identified for outcome~     predictions. The accurate predictions of prognosis through those factors help for the~     decision making on the treatment, i.e. to treat patients of high risk of early progression or~     poor overall survival (OS) with alternative or investigational therapies, while to avoid~     unnecessary over-treatment for low-risk patients.~      CLL is much less prevalent in Eastern countries; presently, most available data on CLL are~     derived mainly from Western countries. However, a previous report concerning the epidemiology~     of CLL in Taiwan revealed a drastic increase in the age-adjusted incidence of CLL, a trend~     not found in Western countries where the incidence rate of CLL remained steadily stable over~     time. In addition to this epidemiological difference, a population-based analysis has found~     the overall outcome of CLL, estimated by relative survivals, is steadily much poorer in~     Taiwanese patients than in US Caucasians. In another report about the cytogenetic profiles in~     a small cohort of CLL patients in Taiwan, a novel cytogenetic abnormality was found to~     correlate with poorer outcomes. These reports suggest the existence of ethnic differences in~     the disease natures of CLL between the East and the West.~      To delineate the possible underlying racial differences, especially in the molecular~     prognostic profiles that might underlie the outcome disparity between Taiwanese and western~     CLL patients, a comprehensive surveillance of the molecular profiles for CLL in Taiwan is of~     importance. In this study, we are going to enroll around 250 CLL patients; their clinical~     parameters will be recorded, their blood samples will be collected for a panel of molecular~     and cytogenetic factor studies. The molecular markers to be tested in this project include~     (but not limited to) cytogenetic abnormalities by fluorescent-in-situ hybridization (FISH),~     immunoglobulin heavy chain variable region (IGHV) hypermutation status, gene mutations for~     Notch1, SF3B1, p53, MyD88, and BIRC3, and the expressions for ZAP70 and stem cell factor~     (SCF). These proposed markers include not only the conventional prognostic markers derived~     from Western studies, and also some novel explorations from our preliminary results, such as~     SCF and trisomy 3. Through this study, a comprehensive profile of CLL in Taiwan will be~     established to identify the characteristics of CLL in Taiwanese patients and to address the~     underlying factors of ethnic differences in the disease nature and outcomes of this disease.~   "
77444|NCT02553291|"~     HIV was once a fatal diagnosis, but due to treatment advances it is no longer a death~     sentence. Today, HIV-infected adults face a new challenge to their health; they are~     developing cardiovascular disease (CVD) earlier and more frequently than those not~     HIV-infected. Reasons for this include toxic effects of HIV medications and activation of the~     immune system. Preventing cardiovascular disease in HIV-infected adults will help them live~     healthier lives; however, there is a lack evidence to help us to achieve this goal. Exercise~     prevents cardiovascular disease, but it is often not addressed in HIV care, due, in part, to~     a lack of practical interventions targeting this population. This study will address this~     problem by testing an intervention to improve and maintain exercise in HIV-infected adults.~      This study will examine the impact of an innovative and sustainable intervention, adapted to~     the unique medical and psychosocial needs of HIV-infected adults, called SystemCHANGE-HIV. It~     consists of six sessions to help redesign an individual's environment and routines to~     increase exercise.This is a randomized trial in which half of the subjects will participate~     in the intervention and half will participate in a control condition. Measures include~     assessments of exercise, fitness, and the markers of cardiovascular health before and after~     the intervention to see if, and how, they changed.~   "
77445|NCT02553278|"~     Prospective, 2-arm, clinical study for the evaluation of the VelaShape device and Contour I~     V3 device for non-invasive fat reduction vs. control.~      All study subjects, who are scheduled for abdominoplasty, will undergo one treatment with~     VelaShape or Contour I V3 device.~      Each arm will be treated with a different device:~      Arm 1: subject will treated with VelaShape device Arm 2: subject will treated with Contour I~     V3 device~   "
77446|NCT02553265|"~     The overall study objectives are to determine whether carbidopa (Lodosyn®) is safe and well~     tolerated and to assess whether it can inhibit catecholamine-induced paroxysmal hypertension~     and normalize or reduce the exaggerated blood pressure variability in patients with familial~     dysautonomia (FD, also called hereditary sensory and autonomic neuropathy type III or~     Riley-Day syndrome). Funding Source- FDA OOPD.~   "
77447|NCT02553252|"~     Patients with post traumatic stress disorder (PTSD) will be randomized to a 12-week~     intervention of Sudarshan Kriya Yoga Trauma Relief Program (SKY) or a wait list control (WLC)~     to assess the effects of this intervention on symptoms of PTSD, depression, anxiety, quality~     of life, autonomic symptoms, and blood inflammatory markers.~   "
77448|NCT02553239|"~     This clinical investigation evaluates the safety of cryoablation (sclerotherapy of muscle~     tissue of the heart by freezing) in paroxysmal atrial fibrillation with the newly developed~     CoolLoop® cryoablation catheter.~      A further aim of the investigation is the evaluation of the efficacy and average duration of~     the applied procedure.~   "
77449|NCT02553226|"~     Background:~      The proposed study will investigate the effect of Syntocinon® (synthetic oxytocin) to induce~     labour. The hypothesis to be studied is that once the active phase of labour has commenced,~     Syntocinon® can be discontinued and the labour process will continue.~      Design:~      Double-blind randomised controlled multicentre trial~      Setting:~      Aarhus University Hospital, Denmark and Regional Hospital of Randers, Denmark~      Population:~      1200 women (600 in each group) stimulated in the latent phase of labour with oxytocin for~     induction~      Methods:~      The Syntocinon® infusion will be replaced with either continuous isotonic saline (placebo) or~     Syntocinon® infusion (control group), when the active phase of labour is reached.~      Main outcome measures:~      Caesarean section (primary outcome), tachysystole, neonatal asphyxia, birth experience~      Perspective:~      Syntocinon® is on the list high-alert medications and associated with complications for~     mother and child during labour. Reducing the duration of stimulation during labour may lower~     the number of asphyxial sequelae and the number of caesarean sections.~   "
77450|NCT02553213|"~     The aim of the study is to investigate, if bariatric surgery or the related caloric~     restriction causes the significant improvement of glucose metabolism, which has been found in~     bariatric patients.~   "
77451|NCT02553200|"~     The efficacy of breathing exercise with oscillated inspiratory loading and oscillated~     positive expiratory pressure for airway secretion clearance and lung function in intubated~     patients, both with and without mechanical ventilation dependence~   "
77452|NCT02553187|"~     The purpose of the study is to explore the efficacy and safety of Kanglaite Injection in the~     treatment of patients with late-stage cancer cachexia.~   "
77453|NCT02553174|"~     The study will investigate the role of NSAIDs in the development of AKI in patients~     undergoing high-risk abdominal or thoracic surgery. The investigators hypothesize that the~     use of new urinary biomarkers will allow earlier detection of AKI than the current gold~     standard, i.e. changes in serum creatinine and/or urine output.~   "
88402|NCT02410005|"~     This study is a single center open-label randomized controlled trial designed to evaluate the~     efficacy of calcitriol plus losartan therapy in subjects with type II diabetes and~     macroalbuminuria.~   "
77460|NCT02553083|"~     The investigators will performed a large-scale multi center trial to compare the efficacy of~     a high-dose dual therapy (HDDT) with that of standard therapies in treatment-naive (n = 300)~     patients with Hp infection. Consecutive symptomatic patients will be recruited in Israel and~     Spain when tested positive to Hp with serology and 13C urea breath test (13C-UBT) due to~     symptoms. Patients with gastric cancer, MALT lymphoma, and younger than 18 or older than 80~     years old will be excluded. All patients will be naive to eradication therapy and will be~     randomized into one of three groups:~      Group 1: Nexium 40 mg and amoxicillin 1.5 gr twice daily for 14 days Group 2: Nexium 40 mg~     and doxycycline 200 mg twice a day Group 3: Triple therapy of Nexium 20 mg, clarythromycin~     500 mg, and amoxicillin 1gr twice a day for 10 days (regular accepted treatment).~      All treatments will be stopped for a month and then 13CUBT will be repeated. The primary aim~     of the study is to assess eradication success, intentioned to treat and per protocol in the~     three treatment regimens.~      The secondary aim of the study is to assess the safety of high dose amoxicillin and~     doxycycline.~   "
77461|NCT02553070|"~     Inaccurate perceptions of the severity of an exposure may result in unnecessary visits to the~     Emergency Department or Health Care Facility which can result in crowding of Emergency~     Departments, unnecessary utilization of valuable health care resources, unnecessary~     treatments, and or mistakes / errors resulting in harm to the patient.~      Inaccurate perceptions about the severity of an exposure can result in delays in proper~     evaluation and treatment resulting in harm or in some cases death of the patient.~   "
77462|NCT02553057|"~     Mechanical ventilation of patients undergoing laparoscopic surgery may induce lung injury.~     Since lung protective ventilation has been recommended during anesthesia to prevent ongoing~     lung injury, so in our study the investigators will compare three different lung protective~     strategies regarding their lung protective effect measured by the incidence of postoperative~     pulmonary complications, perioperative oxygenation and postoperative inflammatory mediator~     release.~   "
77463|NCT02553044|"~     Total 25(OH)D is currently used as a biomarker of vitamin D status. However, there is some~     debate as to whether total 25(OH)D is the best marker to use.~      It has been suggested that free vitamin D may be better because it may be more biologically~     available.~      There are also some uncertainties about how we treat vitamin D deficiency. A single dose is~     attractive because it is certain that the patient has had the dose and there is no~     requirement for ongoing compliance, but it is still not clear what the best dose is to give.~     Also, recent studies have highlighted that high dose vitamin D supplementation may increase~     the risk of falling in older populations.~      The investigators believe that studying how free vitamin D responds to different bolus doses~     is the best way address some of the current research gaps, including what is the best~     biomarker of vitamin D status, what is the mechanism of vitamin D toxicity and what is a safe~     bolus dose to treat deficiency.~      The investigators will study changes in total and free 25(OH)D, and also clinical response,~     to three different bolus doses of vitamin D (50 000IU, 150 000IU and 500 000IU) in 84 vitamin~     D deficient postmenopausal women, over a three month period with 5 study visits. A concurrent~     control group of 28 vitamin D sufficient postmenopausal women will also be recruited.~      This will allow the investigators to determine how total and free vitamin D change with bolus~     dosing and whether there is a disproportionate rise in free 25(OH)D with higher doses that~     may lead to hypercalcemia and falls.~   "
77464|NCT02553031|"~     This study will explore the potential value in proper therapeutic decision and clinical~     outcome prediction by using integrated MR-PET system and advanced MR techniques in patients~     with colorectal cancer.~   "
77465|NCT02553018|"~     The primary objective of the study is to compare, in patients treated with methotrexate~     injection for rheumatoid arthritis, the compliance and the health assessment questionnaire~     evolution for the administration by auto-injector versus administration by conventional~     subcutaneous injection, after 6 months of treatment.~   "
77466|NCT02553005|"~     Rheumatoid Arthritis (RA) is a systemic inflammatory disease characterized by functional~     disability and pain. Although acupuncture is widely used, western acupuncture studies on RA~     show no conclusive positive result. Acupuncture is regarded as a reflex therapy, and~     Traditional Chinese Medicine (TCM) diagnosis was shown to be an individual neurovegetative~     state allowing to individually allocated acupoints. Positive results were reported using a~     classical diagnostic procedure to allocate acupoints to the patient according to the Shang~     Han Lun. The investigators are interested if acupuncture compatible with this ancient theory~     would be successful in improve hand function in RA patients.~      The investigators therefore developed a prospective randomized control trial in a three-armed~     parallel group design with a standardized treatment intervention. Only patients with the TCM~     diagnosis of a so-called Turning Point syndrome will be allowed in the experimental phase.~     This may harmonize TCM diagnosis and the standardized intervention, in order to optimize~     potential therapeutic effects.~   "
77467|NCT02552992|"~     This study is a pilot, randomized controlled trial to provide feasibility and conduct~     preliminary analyses on physical (strength and stretch) mechanisms associated with a yoga~     intervention for non-specific chronic low back pain (cLBP). Recent large-scale trials have~     demonstrated the efficacy of a yoga intervention for cLBP however, many types of yoga classes~     are available to the public and a specialized yoga protocol for individuals with cLBP is~     needed. This study's goal is to quantify trunk strength and flexibility to better understand~     how these potential physical mechanisms specifically lead to improvement in pain-related~     outcomes including pain and disability. This knowledge will be used to design a large scale~     trial of mechanisms of yoga for cLBP. For this pilot study, 40 participants will be~     randomized to either a yoga intervention (N=20) or to a usual care group (N=20) that will~     receive The Back Pain Helpbook, a mind-body self-care program for better living. The yoga~     intervention will be offered weekly yoga classes and instructional materials will be provided~     for home practice.~   "
77468|NCT02552979|"~     Positive reactions in atopy patch test in children with atopic dermatitis.~   "
77500|NCT02552563|"~     This pilot study seeks to examine the extent to which, relative to usual care, a dementia~     care management program for veterans and their caregivers (CGs)improves patient (e.g.,~     behavioral symptoms, delayed nursing home placement) and caregiver (e.g., CG mastery, burden,~     affect) outcomes.~   "
88796|NCT02404831|"~     The purpose of this pilot study is to compare a six week web-based pulmonary rehabilitation~     programme with traditional hospital-based pulmonary rehabilitation classes for people~     affected by COPD.~   "
77469|NCT02552966|"~     It is postulated that the incompetence of the upper esophageal sphincter (UES) to restrict~     passage of esophageal refluxate is fundamental to the development of LPR. The UES Assist~     Device (UESAD) is a novel device that applies relatively modest external cricoid pressure,~     which results in a 20 to 30 mmHg intraluminal UES pressure increase. Pepsin, a proteolytic~     enzyme produced in the stomach, has been detected in the laryngeal epithelium of patients~     with reflux associated laryngeal symptoms and implicated in the pathogenesis of~     laryngopharyngeal reflux. This study will asses the effectiveness of a UESAD worn for 2 weeks~     on LPR symptoms and salivary pepsin levels.~   "
77470|NCT02552953|"~     This is an open-label, single arm, dose escalation study in patients with advanced cancers.~   "
77471|NCT02552940|"~     This observational trial will evaluate the effectiveness, the consistency of evaluation~     scores, quality of life, safety and tolerability of TCZ administered subcutaneously (SC) in~     participants with RA in daily clinical practice.~   "
77472|NCT02552927|"~     Infants will be randomized to either chest shielding with aluminum foil or chest shielding~     without aluminum foil while undergoing phototherapy for premature infants. The primary~     outcome is patent ductus arteriosus.~   "
77473|NCT02552914|"~     Study objectives:~        -  To evaluate the usability of the Colli-PeeTM device to collect first-void urine for~          nucleic acid detection of Neisseria gonorrhoeae, Chlamydia trachomatis, Trichomonas~          vaginalis and Mycoplasma genitalium.~        -  To collect feedback on the easiness of use and the willingness of future use of the~          Colli-PeeTM device.~   "
77474|NCT02552901|"~     Performance evaluation of LFT Dye Monitor System using ICG - plasma disappearance rate value~     (PDR) to assess liver function in normal patients as well as in patients with mild to severe~     hepatic impairment compared to manual Serum ICG PDR.~   "
77475|NCT02552888|"~     The proposed randomized controlled trial will test the safety and efficacy of combination~     therapy with sodium nitrite and isoquercetin on endothelial function and inflammation among~     patients with chronic kidney disease.~   "
77476|NCT02552875|"~     Repetitive nerve stimulation is used to monitor the neuromuscular transmission function in~     infants, children and adults after the application of muscle relaxants. During repetitive~     stimulation of a motor nerve, amplitude of contractions of the corresponding muscle will~     increase to a plateau (twitch potentiation), which is known as the staircase phenomenon.~      There is no systematic information about the staircase phenomenon of the adductor pollices~     muscle (ulnar nerve) in children between 1 month and 18 years .~      In adults , a 50-Hz tetanus administered before initial twitch stabilization is able to~     shorten the twitch stabilization period and to eliminate this staircase phenomenon.~      The purpose of this study is to investigate the characteristics of twitch potentiation in~     children between 1 month and 18 years by using acceleromyography.~      In addition we investigate whether application of a 50-Hz tetanic stimulation is able to~     eliminate the twitch potentiation like in adults.~   "
77477|NCT02552862|"~     Study Design: Double-blind placebo-controlled clinical trial~      Study Duration:2 years~      Study Center: Hospital de la Santa Creu i Sant Pau, Barcelona (single center)~      Objectives: To assess the effect of adjunctive Vivomixx® on bacterial translocation in~     patients with cirrhosis and SBP~      Number of Subjects: 30~      Main Inclusion Criteria: Patients with cirrhosis hospitalized with an episode of SBP at~     Hospital de la Santa Creu i Sant Pau~      Study Product, Dose, Route, Regimen: Vivomixx ® sachets containing 450 x 109 bacteria, 2~     every 12 hours during hospitalization (n=15), or placebo (n=15)~      Duration of administration: During hospitalization due to SBP episode~      Hypothesis: The adjunctive treatment with Vivomixx® in patients with cirrhosis and SBP could~     decrease bacterial translocation and systemic and cerebral proinflammatory state. This would~     result in a faster SBP resolution, a decrease in the incidence of complications and an~     improvement in cognitive function.~   "
77478|NCT02552849|"~     This is a multi-center, non-interventional study to assess and describe course and outcomes~     in patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) who are treated with Esbriet~     (pirfenidone) in Canada, by measuring and reporting observed predicted forced vital capacity~     (FVC) change from baseline on an ongoing basis.~   "
77479|NCT02552836|"~     The primary aim of this randomized controlled trial is to determine the acute antidepressant~     efficacy of interpersonal psychotherapy (IPT) in depressed patients with Parkinson`s Disease.~   "
77480|NCT02552823|"~     Diabetes is one of the most common chronic diseases affecting Canadians (PHAC, 2011).~     Lifestyle modifications that include a diet high in fibre may lower the risk of developing~     type 2 diabetes (CDA, 2013). In this context, the presence of fibre in carbohydrate rich~     foods has been widely recognized for its effect on post-prandial glucose response (PPGR).~     Peas are high in fibre and protein and show great potential as a functional food. A health~     claim for PPGR would increase market demand for peas, and help those who want to limit the~     rise in blood sugar after a meal choose products to meet their goals, but there are several~     gaps in the literature that need to be filled before a submission to Health Canada can be~     successful: 1) test foods in appropriate serving sizes; 2) test both the glucose and insulin~     response; 3) test varieties of peas that that currently available on the market; 4) test~     whole/split peas (not fractions or isolates); 5) compare peas to appropriate starchy~     reference food (rice or potato). The proposed study design will address all of these gaps in~     the current literature and take into consideration Health Canada's guidance document for~     health claims related to the reduction in PPGR, which sets out the criteria by which the~     validity of such claims will be assessed.~      Specific objectives~        1. To determine the effect of 3 common market classes of peas on PPGR and insulin response~          in a cross-over, randomized, controlled clinical trial.~        2. To assess the effect of 3 common market classes of peas on appetite-related sensations~          using visual analog scales.~        3. To demonstrate whether the test and reference products were liked or disliked similarly~          by participants.~        4. To assess any gastrointestinal side effects from eating the test products~   "
77481|NCT02552810|"~     Contamination of implant abutments could potentially influence the peri-implant tissue~     inflammatory response. The aim of the present study was to assess the radiographic bone~     changes around customized, platform switched, abutments placed according to the~     one-abutment-one-time protocol, with and without plasma of argon cleaning treatment.~   "
88797|NCT02404818|"~     The purpose of this study is to evaluate if radiation and chemotherapy treatment cause~     cardiac abnormalities among survivors of Hodgkin's lymphoma.~   "
77482|NCT02552797|"~     Patients should be able to have a say in their care and treatment, but how this should work~     for children and young people with mental health difficulties is unknown. For example, how~     and when do young people want to be involved in decision making, and what is important to~     them, their parents/guardians and healthcare professionals? This project will address these~     questions and will develop a tool known as 'Power Up' to help young people with mental health~     difficulties make decisions about their own care and treatment.~      This project will run for 24 months and will:~        1. Understand the beliefs, experiences, and values of young people, their parents/guardians~          and clinicians around shared decision making (SDM) in mental health.~        2. Use these responses to develop 'Power Up'; a tool to help young people make decisions~          about their care or treatment in mental health services.~        3. Pilot 'Power 'Up' in child and adolescent mental health services to estimate the number~          of patients who would want to use Power Up and to see whether patients can be recruited~          and followed up with measures. The pilot study would investigate randomisation, see how~          clinicians cooperate, and identify barriers to collaboration and ways of overcoming~          these.~      Forty five young people, parents and clinicians will be recruited for interviews and focus~     groups to inform tool development. Sixty young people aged 1116 will be recruited for the~     pilot/feasibility study. Measurements will be collected at baseline, session by session, and~     at the end of treatment.~   "
77483|NCT02552784|"~     The general objective is study medical, socioeconomic, behavioral, health environmental,~     school and professional integration, and short- and medium- term quality of life determinants~     for all patients under 18 years old, residing in France for which the diagnosis of inherited~     metabolic diseases with specific regime (MHMRS) has been achieved during their childhood.~   "
77484|NCT02552771|"~     Multicentre, double-armed, randomized controlled trial designed to compare mitral valve~     leaflet resection versus leaflet preservation with regards to the development of functional~     mitral stenosis following surgical repair of mitral valve prolapse. Patients will be~     randomized (1:1) to receive: (1) mitral valve repair with a leaflet resection or (2) mitral~     valve repair with leaflet preservation (using polytetrafluoroethylene neochordae), followed~     by echocardiographic and clinical assessment at 12-months following surgery.~   "
77485|NCT02552758|"~     Investigators plan to explore whether Omega-3 fatty acid have effect on the violent behavior~     of the schizophrenia patients. Investigators will use PET to explore the influence on~     serotonin function of the brain to understand the mechanism of how Omega-3 fatty acid works.~     This study will enroll 100 patients of schizophrenia with violent behavior.Participants will~     be split into two groups randomly. In one group, participants will receive one pill of~     placebo per day, and in the other, participants will have one pill of 900mg Omega-3 fatty~     acid per day. This intervention will last 3 months.At week 0, week 4, week 8 and week 12,~     some scales will be evaluated. Meanwhile, the density of eicosapentaenoic~     acid(EPA),docosahexaenoic acid (DHA),noradrenalin(NE), dopamine(DA) and serotonin(5-HT) in~     blood will be tested.At week 0 and week 12, 10 patients of each group will be randomly~     selected to have the exam of PET.~   "
77486|NCT02552745|"~     This study is aiming to understand the effects of parecoxib on the postoperative~     complications of hepatocellular carcinoma (HCC) patients undergoing hepatic transcatheter~     arterial embolization (TACE). The investigators enrolled 242 patients who were diagnosed with~     HCC for the first time and who received hepatic TACE at the Cancer Prevention and Treatment~     Center of Sun Yat-sen University from October 2014 to March 2015 were prospectively enrolled.~     The patients were divided into study and control groups according to whether parecoxib sodium~     was administered postoperatively. Pain scores,body temperature, vomiting, and changes in~     liver function after surgery, as well as the length of the hospital stay, were recorded and~     compared.~   "
77487|NCT02552732|"~     The aim of this feasibility study is to provide data for a subsequent randomized controlled~     trial to investigate if patient outcomes will be improved after an acute COPD exacerbation~     using domiciliary nasal high flow therapy (NHF) compared to standard care. This feasibility~     study will investigate the following: process, resources, management and scientific aspects~     of delivering NHF as an adjunct therapy in COPD patients.~   "
77488|NCT02552719|"~     Purpose of the study is the validation of the German version of the Injustice Experience~     Questionnaire.~      Pretest: Participants were informed about the aims of the study and fill in a consent form.~     They filled in a paper version of the German translation of the Injustice Experience~     Questionnaire. In a structured interview patients were asked if there were any items~     difficult to understand, unacceptable or offending them. Subsequently they had to answer~     questions about the content and meaning of the IEQ-items.~      Validation Study: Participants were informed about the aims of the study and filled in a~     consent form. By e-mail they received an access link to the online survey. The questionnaires~     of the survey could be filled in at home. The survey could be interrupted and terminated~     later. About 20 minutes were needed to answer the 80 questions of the survey. All data was~     saved anonymously during the survey.~   "
77489|NCT02552706|"~     The purpose of this study is to investigate the efficacy and its mechanisms of oral mixture~     probiotics in preventing necrotizing enterocolitis among the preterm very low birth weight~     infants.~   "
77490|NCT02552693|"~     This study evaluates the effectiveness of an enhanced package of support for activities~     described in the Standard Operating Procedures (SOP) for Patient Tracing in Health~     Facilities in Zimbabwe. This package is intended to increase the effectiveness of active~     patient tracing activities by developing tools, providing mentorship and implementing~     systematic review of processes to improve communication, coordination, and supervision~     between community health workers and facility-based staff.~   "
77501|NCT02552550|"~     The curative treatment and organ preservation in advanced squamous cell carcinoma of the~     oropharynx is multimodal. It involves induction chemotherapy and depending on the response~     radio-chemotherapy or surgery. The combination of these methods has important functional~     consequences.~      The aim of this prospective pilot study is to describe swallowing, speech, but also patients'~     quality of life before and after therapeutic management (existing studies measuring these~     functions after treatment but not before).~   "
77502|NCT02552537|"~     In patients with a walnut allergy double blind placebo controlled food challenge with walnut~     will be combined with the intake of proton pump inhibitor (PPI) or with placebo to assess the~     impact of PPI on threshold level and on clinical manifestation.~   "
77491|NCT02552680|"~     Introduction: Work-Related Musculoskeletal Disorders (WMSDs) are characterized by~     inflammation of muscles, tendons, fascia and nerves of upper limbs, shoulder girdle and neck.~     Its incidence is increasing and there is evidence of its association with the pace of work.~     As WMSDs, another major public health problem is back pain, which also negatively influence~     the quality of life of patients. These diseases affect many workers, among them, workers in~     the health area, including surgeons. Studies show that many surgeons are suffering from~     fatigue and musculoskeletal pain after undergoing surgery, especially laparoscopy. Regarding~     the quality of life of doctors, a study indicates that surgeons have commitment of domains~     Vitality and Pain. For these reasons it is important to develop strategies for prevention~     of occupational risks (WMSDs) in this class of workers.~      Objectives: To evaluate the influence of a Preventive Program (educational and gymnastics)~     for prevention of WMSDs, in the quality of life, in limitation of the work, in intensity and~     frequency of musculoskeletal pain in surgeons of the Hospital de Clínicas de Porto Alegre.~     There will also be evaluated the effects of the program on muscular strength and flexibility~     of medics participating in the Preventive Program.~      Methodology: Randomized clinical trial with a sample of 54 surgeons, divided into two groups:~     A (Intervention: will participate in eight meetings consisting of exercise and guidelines~     on care and prevention of WMSDs in activities of daily living, especially those relating work~     activities) and B (Control: will receive a manual-brochure - containing information about~     general health). Participants will sign a Letter of Consent.~   "
77492|NCT02552667|"~     Efficacy and safety of HCP1102 capsule : A randomized, double-blind, active-controlled,~     multicenter phase 3 clinical trial.~   "
77493|NCT02552654|"~     Intrusive memories of traumatic events are core features of posttraumatic stress disorder~     (PTSD) but little is known about the neurobiological formation of intrusions. The aim of this~     study was to determine whether cortisol levels during an intrusion-inducing stressor~     influence subsequent intrusive memories.~   "
77494|NCT02552641|"~     The purpose of the study is assess whether the various forms of triple regimen of~     administration of treatment of Helicobacter pylori (before meals (fasting), after meals, and~     any independent mealtime) influence the rate of eradication of this bacterium.~   "
77495|NCT02552628|"~     Dystonia in Wilson's disease represent a major issue. The persistence of disabling motor~     symptoms despite medical treatments justifies conducting a study on deep brain stimulation~     (DBS) in Wilson's disease (WD). For bradykinetic patients, subthalamic nucleus (STN) could be~     considered as a better target than the globus pallidus (GPi). For patients with hyperkinetic~     dystonia, the internal globus pallidus (GPi) will be chosen as the target of DBS.~      The investigators hypothesize that STN DBS will improve Wilson's disease patients, who,~     despite copper chelators drugs, are still impaired by severe dystonia and akinesia (more or~     less associated with other movement disorders).~      The investigators primary objective is to demonstrate the efficacy of STN/GPi DBS on dystonia~     associated with Wilson's disease.~      Secondary objectives:~        -  To evaluate the impact of STN/GPi DBS on other movements disorders (tremor,~          Parkinsonism, chorea) observed in Wilson's disease.~        -  To describe cognitive status of patients and to evaluate the consequences of STN/GPi DBS~          on cognition and behavioral aspects of the disease.~        -  To evaluate the consequences of the stimulation on speech and swallowing.~        -  To evaluate the social impact of STN/GPi DBS in Wilson's disease.~        -  To evaluate the safety of STN/GPi DBS in the specific context of Wilson's disease.~   "
77496|NCT02552615|"~     The aim of this study was to compare the effects of spinal stabilization and body awareness~     in addition to brace wearing versus classical exercises on subjective verticality perception,~     trunk symmetry and quality of life in AIS. Study included 30 AIS patients between the ages of~     14.40±201 years (stabilization group), 14.2±2 years (Body awareness) and 13.60±1.65~     (classical). Cobb angles, rotation, subjective visual (SVV), postural (SPV) and haptic (SHV)~     and deformity perception, quality of life were assessed at baseline and after 10th week of~     treatment. Cobb angle decreased in stabilization and awareness groups. Rotation decreased in~     three groups. SVV improved in all groups. SPV and SHV, body asymmetry and cosmetic deformity~     improved in stabilization and awareness groups. Only function improved with stabilization~     treatment. Stabilization and body awareness exercises created positive changes in AIS.~   "
77497|NCT02552602|"~     Micronutrient deficiencies in people living with HIV have been reported. Multivitamins can~     address micronutrient deficiencies, however the benefits of multivitamins in people living~     with HIV is still debatable. While some multivitamin intervention studies have reported the~     benefits of multivitamins in HIV infection, some other studies have reported no statistical~     differences in outcomes of interest in intervention and control groups. With clear~     differences in composition and strength of the multivitamins used in the different studies,~     it is possible that some of the multivitamins used in some of the intervention studies may~     have been unable to meet existing micronutrient deficiencies. Hence there is a chance that~     higher strength multivitamins may be better able to correct these deficiencies and result in~     better outcomes. This study will therefore compare three different multivitamins varying in~     strength and composition to determine if any one of the three multivitamins will produce~     better health outcomes.~   "
77498|NCT02552589|"~     The purpose of this double blind study is to prove whether a fluoride containing toothpaste~     is able to reduce dental plaque and gingival inflammation in patients who have gingivitis~     when applied twice daily during brushing at home over a period of 12 weeks.~   "
77499|NCT02552576|"~     This is a multi-centre, open-label, single-arm, phase 4, post-marketing study to further~     investigate the efficacy and safety of Voncento in subjects with Von Willebrand Disease (VWD)~     in whom treatment with a Von Willebrand Factor (VWF) product is required as on-demand~     therapy, for prophylactic therapy, or during surgery. Subjects will be treated with Voncento~     either as an on-demand regimen (eg, to treat a non-surgical spontaneous or traumatic bleeding~     event) or prevention regimen (eg, to prevent an anticipated bleeding event) at a dose~     prescribed by the Investigator in accordance with the Voncento Summary of Product~     Characteristics (SmPC), or with a prophylaxis regimen (regular treatment with Voncento at a~     frequency of 1-3 times per week). Voncento will also be given to prevent and treat any~     surgical bleeding events.~   "
78649|NCT02537457|"~     The objectives of this study are to establish the bioequivalence between rivaroxaban tablet~     15 mg and rivaroxaban granule formulation 15 mg, and to assess the safety and tolerability of~     rivaroxaban 15 mg in healthy adult male subjects.~   "
77503|NCT02552524|"~     The gambling problem is characterized by a loss of control and an excessive focus on the~     gambling practice. Currently, the treatment of pathological gamblers is often complex and~     multidimensional, it notably includes psychological techniques including cognitive behavioral~     therapy and the use of psychotropic drugs.~      In pathological gambling and addictions, craving (or urge to play) and loss of control are~     two essential clinical elements. The neurobiological level, they are associated with a~     dysfunction of dorsolateral prefrontal cortex (DLPFC) (Goldstein et al, 2001, Volkow and~     Goldstein, 2002).~      One therapeutic avenues explored in addictions is repeated transcranial magnetic stimulation~     (rTMS).~   "
77504|NCT02552511|"~     A Multicentre, observational and cohort study to get the incidence of new-onset or~     newly-diagnosed seizure in neonatal population. EEG will used to record the change of brain~     electric activity and diagnose. Other data also will be collected since first seizure until~     confirmed diagnosis.~   "
77505|NCT02552498|"~     Apply the LASCA for follow-up the postocclusive microcirculation after strangulation of the~     gingiva in order to characterize the kinetics of the blood flow changes in human subjects.~   "
77506|NCT02552485|"~     Prospective, monocentric study for the evaluation of latent pulmonary arterial hypertension~     in patients with congenital shunt lesions lost to follow-up. Lost to follow-up is defined as~     latest clinical control ≥ 5 years.~   "
77507|NCT02552472|"~     This is a prospective cohort observational study of inhaler adherence in a community care~     setting (ie. general practice clinics and pharmacies in the community).~   "
77508|NCT02552459|"~     The purpose of this study is to determine effect of combined medication of sufentanil and~     dexmedetomidine in patient controlled analgesia after neurosurgery.~   "
77509|NCT02552446|"~     Indirect calorimetry is the gold standard to measure energy expenditure. In fact it is not~     always available and inconstantly feasible. Various equations for predicting energy~     expenditure based on body weights have been created. This study aims at determining the best~     suitable predictive strategy unless indirect calorimetry is available.~   "
77510|NCT02552433|"~     The objective of this study is to describe the wound related complication rate in~     post-bariatric body contouring surgery patients who are treated according to the new Dutch~     guideline and to asses the factors associated with a higher complication rate.~   "
77511|NCT02552420|"~     The purpose of this study is to determine the effectiveness of infrared thermal imaging in~     adjunctive diagnostic screening for lower limb deep venous thrombosis (DVT).~   "
77512|NCT02552407|"~     During primary percutaneous coronary intervention, distal embolization of thrombus and~     impaired microvascular perfusion has been associated with an increased mortality.~     Thrombectomy devices during primary percutaneous coronary intervention may prevent distal~     embolization by reducing thrombus burden and thus improve microvascular perfusion and reduce~     mortality.~   "
77513|NCT02552394|"~     This clinical trial is for men with advanced prostate cancer that may have spread to other~     parts of the body.~      Currently, once prostate cancer cells have spread from the prostate to other organs it is not~     treatable by surgery. The purpose of this study is to treat patients with an experimental~     antibody (i.e. that has not been FDA approved) called J591 that attaches itself to a special~     protein on cancer cells called PSMA to try to eliminate these cancer cells (called~     circulating tumor cells) from the circulation.~      In the initial phase of the study, 6 participants will receive the experimental J591~     treatment. Routine blood tests, research blood tests, physical exam will be performed at each~     visit. Participants will also be asked to complete a questionnaire about how they are~     feeling. Participants will have a radiographic scan every 3 months to check the status of~     their disease.~      Participants who tolerate the treatment well may be re-treated at the same level every 3~     months, and may continue on treatment as long as they are responding to therapy and not~     experiencing unacceptable side effects.~   "
77514|NCT02552381|"~     The purpose of the study is to assess the fibrin structure marker in the plasma of cancer~     patients, treated or not treated with LMWH at prophylactic or therapeutic doses, in order to~     determine the venous thromboembolic risk. The occurrence of thromboembolic events in patients~     without treatment and in patients under LMWH treatment will be recorded, depending on the~     location and type of cancer, metastases, and treatment of cancer.~   "
77515|NCT02552368|"~     The ultimate goal of this project is to develop a functioning and clinically feasible method~     for restoring function to motor-impaired stroke survivors. This ultimate goal will be~     approached through two different means. The first method is to develop a functioning~     brain-computer interface that operates based on cortical activity ipsilateral to an intended~     movement on the motor-impaired side of the body. And secondly, to develop new methods of~     rehabilitation that involve stimulating peripheral muscles based upon cortical activity~     ipsilateral to intended movements. Finally, the study seeks to assess changes in functional~     connectivity as a result of using a BCI device.~   "
77516|NCT02552355|"~     The investigators propose that post-exercise milk protein feeding will enhance the~     mitochondrial protein synthesis (biogenesis) response to an exercise-training program. In~     addition, the investigators propose that this stimulatory effect of protein feeding will~     overcome the potential blunting effect of metformin on exercise responses. The investigators~     will investigate these outcomes over a 12-week exercise-training program in older adults with~     pre-diabetes with or without metformin treatment.~   "
77517|NCT02552342|"~     The purpose of the present study is to assess the efficacy of methylprednisolone as an~     adjuvant therapy in patients with severe community-acquired pneumonia (CAP) (PSI 4-5).~      The hypothesis of the study is that methylprednisolone can decrease the mortality of severe~     CAP without any significant side effects,with reduction of the time to clinical stability and~     failure rate of treatment.~   "
77518|NCT02552329|"~     Most research on Tai Chi has been done in the area of balance and falls. Studies examining~     the effects of Tai Chi exercise on cognitive function are sparse especially in the population~     of MCI. Therefore, the aims of the present study are: 1) to examine the effects of Tai Chi~     exercise on cognitive function of elderly with MCI, and 2) to investigate the effects of~     6-month Tai Chi exercise on serum biomarkers in individuals with MCI.~   "
77519|NCT02552316|"~     The ASPIRE study is a clinical trial designed to examine the microbes (e.g., bacteria) within~     psoriasis skin lesions compared with normal skin. The investigators will also examine the~     effect of NB-UVB (narrow-band ultraviolet B) phototherapy (i.e., light therapy) on skin~     microbes.~   "
77520|NCT02552303|"~     The purpose of this study is to assess the effects of Armodafinil, CBT-I, or the combination~     of the two on the sleep continuity of persons suffering from sleep disordered breathing and~     their adherence to CBT-I and Continuous Positive Airway Pressure (CPAP). Adults diagnosed~     with obstructive sleep apnea and who meet additional research and diagnostic criteria for~     insomnia will be recruited. Participants will submit daily sleep diaries and supplemental~     questionnaires as measures of study progress.~   "
77521|NCT02552290|"~     The proposed project seeks to evaluate the influence of cervicothoracic (CT) manipulation and~     passive stretching to the upper trapezius on pressure pain thresholds and range of motion~     (ROM) in individuals without recent complain of neck pain.~   "
77522|NCT02552277|"~     This is a Phase 2, randomized, double-blind, placebo-controlled, dose range finding study in~     subjects who have diabetic peripheral neuropathy (DPN). The study will enroll approximately~     24 subjects. Subjects will be randomized to receive one of 3 treatments: PDA-002 (3 x 10^6~     cells), PDA-002 (30 x 10^6 cells), or placebo (vehicle control) in a 1:1:1 randomization~     approach. Investigational product or placebo will be administered monthly (3 administrations~     total on Study Days 1, 29, and 57).~   "
77523|NCT02552264|"~     The Behaviour Change Institute (BCI) was created in 2008 within Capital Health to provide~     healthcare providers with evidence-based skills in helping patients change. In addition, the~     BCI has also become a resource within the organization to assist with other needed changes,~     such as helping healthcare providers use new or different procedures to provide better~     patient care. Through our work at the BCI we have identified the need to help healthcare~     providers to better cope with change. The purpose of this project is to implement and to~     evaluate an evidence-based professional resiliency training program for staff to help them~     better cope with change. This professional resiliency training program is based on an~     empirically supported form of therapy called Acceptance and Commitment Therapy. The training~     takes the form of a hands-on, applied workshop designed to increase resiliency and~     flexibility in a workplace setting.~   "
77524|NCT02552251|"~     Congenital adrenal hyperplasia (CAH) results from a deficiency of a key enzyme in the~     biosynthesis of cortisol, mainly 21-hydroxylase, resulting in its classic form a neonatal~     salt loss syndrome and / or a virilization syndrome in girls. The treatment of the disorder~     in adulthood involves administering steroidal compounds with the aim to substitute the gluco-~     and mineralocorticoid deficit on the one hand, and effectively curb the adrenal hyperplasia~     and adrenal androgen pathway in girls . The terms of glucocorticoid treatment are not clearly~     codified and are based on several steroidal compounds and various protocols. The advantages~     in terms of adrenal suppression and disadvantages - including bone and metabolic - different~     treatments have not been clearly established in the literature. The main objective of this~     study is to compare among adults with HCS in its classical form the impact on hormonal~     parameters adrenal suppression glucocorticoid of 3 types of treatment administered to~     equivalent dose and according to the usual procedures. The secondary objective is to compare~     in the same patients the impact of different drugs and treatments on several metabolic bone~     parameters. The study will include 40 adult patients bearing a HCS in its classical form and~     will include 3 treatment sequences of eight weeks each, during which they will be~     administered sequentially in random order at random and according to the known equivalences~     hydrocortisone, prednisone (CORTANCYL) and dexamethasone (DECTANCYL).~      Randomization will be stratified based on previous DMARDs in the investigation that may be~     different for different patients, knowing that France hydrocortisone and dexamethasone are~     used mainly for the treatment of congenital adrenal hyperplasia. The judging criteria will~     be: i) the criteria of adrenal hormone suppression: plasma levels of testosterone,~     androstenedione, 17 OHP, ACTH and diurnal variations of the 17 OH progesterone salivary ii)~     the criteria of the metabolic impact of glucocorticoids: plasma glucose levels , blood~     lipids, and insulin sensitivity index HOMA-R calculated from glucose and insulin, iii) the~     criteria of bone impact of glucocorticoids: plasma for CTX bone resorption and bone alkaline~     phosphatase P1NP for bone formation iv) the living quality criteria evaluated by the PGWB~     Questionnaire (Psychological General Well-Being). The duration of the study period will be 24~     months.~   "
77525|NCT02552238|"~     The purpose of this study is to assess the safety and efficacy of Lumason-enhanced dobutamine~     stress echo (DSE) in subjects having a suboptimal left ventricular endocardial border~     delineation (LV EBD) at rest and who are scheduled for coronary angiography.~   "
77526|NCT02552225|"~     This randomized, double-blind, placebo-controlled trial will compare the effectiveness of~     amitriptyline versus placebo (inactive medication) in treating chronic laryngitis.~   "
77527|NCT02552212|"~     Patients with active Axial Spondyloarthritis without x-ray evidence of Ankylosing Spondylitis~     and with signs of inflammation will be randomly assigned to receive certolizumab pegol (CZP)~     200 mg every two weeks or placebo. The primary objective is to demonstrate the efficacy of~     CZP in these patients.~   "
77528|NCT02552199|"~     To evaluate the gravimetric sweat measurements in subjects who meet the subjective criteria~     for a diagnosis of palmar hyperhidrosis compared to subjects without hyperhidrosis.~   "
77529|NCT02552186|"~     Pectus excavatum (PE), the most common congenital chest wall deformity, requires surgical~     repair when the degree of deformity is severe. Currently, the Pectus Index (PI) is used to~     classify PE severity. Calculation of the PI requires cross-sectional imaging of the chest,~     usually with computed tomography (CT) or Magnetic Resonance Imaging (MRI), to obtain the~     necessary measurements. However, CT delivers a high dose of ionizing radiation, which carries~     cumulative long-term risks of malignancy and MRI can be costly. The purpose of this study is~     to develop a method whereby accurate chest wall measurements can be obtained to quantify PE~     severity without the need for cross-sectional imaging.~   "
77530|NCT02552173|"~     Investigators prospectively evaluate the accuracy of intraoperative stem anteversion in~     40consecutive total hip arthroplasties.~   "
77531|NCT02552160|"~     Prospective, multi-centre, non-interventional study to collect findings about the effects of~     LABA/LAMA (Long Acting Beta2-Agonists / Long Acting Muscarinic Antagonists) combination~     preparations on COPD (Chronic obstructive pulmonary disease) symptoms and quality of life~     under real conditions and to find out what types of patients are selected for this therapy by~     physicians.~   "
77532|NCT02552147|"~     Some individuals with autism spectrum disorders (ASD) also demonstrate irritability or~     aggression, which can interfere with functioning. The purpose of this pilot study is to test~     whether transdermal nicotine is effective for irritability and/or aggression in adults with~     ASD using a double-blind, placebo-controlled clinical trial. Subjects will participate in~     three visits. At the first visit, subjects are screened for eligibility and enrolled.~     Baseline measures include rating scales and a frustrative computerized task. They will then~     wear seven days of transdermal nicotine or placebo. Visit two is on day seven and the study~     measures are repeated, vital signs and side effects monitored. Subjects will return for a~     third and final visit on day 21 to repeat the study measures performed during visit two.~   "
77568|NCT02551679|"~     The primary objective of this study is to determine the efficacy and safety of intramuscular~     injection of ACP-01, comprised of blood-derived autologous ACPs, in subjects with critical~     limb ischemia who are receiving standard of care therapy and have no endovascular or surgical~     revascularization options.~   "
77533|NCT02552134|"~     Background: More than 10% of the adult population in Styria, a federal state in the south of~     Austria, is allotted to a stationary stay at a health resort each year. In practice~     approximately 50.000 adults receive these stays that are financed from the health insurance~     companies and that last up to 3 weeks. The target group for theses stays is the general~     population aged between 30 and 65 years that shows minor health deficits like back pain or~     risk factors for cardio-metabolic diseases. The treatment during the stays consists of~     exercise, nutritional and psychological interventions. Thus the increase of physical activity~     is an important goal that is focussed during the stationary stay. Because of the absence of~     regional facilities that are linked to the resorts and that provide accesses to standardised~     regional programmes sustainability is questionable.~      Methods/Design: This prospective controlled open label study compares two study groups. After~     a stationary stay at a health resort patient are allocated to a standardised, regional~     sports-club based exercise programme or to another group, where only written hand-outs are~     provided. The primary outcome is the weekly level of health enhancing physical activity which~     is objectively measured with an accelerometer and an activity log-book. Additionally, social~     determinants are requested, fitness and anthropometric measurements are done at baseline~     until 12 months. Beside the changes in measurable parameters, processes are evaluated~     accurately. Consequently the gateway - function of the health resort is analysed.~      Discussion: The structured cooperation between the health sector, where health resorts~     informing and assigning patients to regional sports-clubs and the sports sector potentially~     provides a wide network of standardised programmes. Within this study we aim to evaluate the~     sustainability of stationary stays and a continuing regional standardised exercise programme.~   "
77534|NCT02552121|"~     The purpose of the trial is to establish the tolerability of tisotumab vedotin (HuMax-TF-ADC)~     in a mixed population of patients with specified solid tumors~   "
77535|NCT02552108|"~     Generalized Anxiety Disorder (GAD) is a chronic condition that is characterized by excessive~     and uncontrollable worry and anxiety. In Canada, 3 to 4% of the population suffer from GAD at~     any point in time. These individuals have a lowered quality of life and are at risk for many~     medical conditions such as coronary heart disease and cancer. Research suggests that both~     pharmacological and psychological approaches are effective for treating GAD in the~     short-term; however, psychological treatments appear to offer the greatest long-term~     benefits. There exist a number of effective psychological treatments for GAD, most of which~     fall into the category of cognitive-behavioural therapy or CBT. In the 1990s, a group of~     Canadian investigators developed a CBT protocol for GAD that included four components. Data~     from five clinical trials suggest that one of the four components is particularly important~     for treatment success: experiencing uncertainty rather than avoiding it in everyday life.~     Stated differently, learning to tolerate and deal with uncertainty appears to be the key to~     decreasing worry and anxiety. Given this finding, the investigators have developed a new~     treatment that exclusively targets intolerance of uncertainty: Behavioural Experiments for~     Intolerance of Uncertainty or BE-IU. The goal of the current proposal is to test the efficacy~     of BE-IU by comparing it to a Waiting List (WL) control condition. A total of 50 participants~     with a primary diagnosis of GAD will be randomly assigned to either BE-IU or WL and will be~     assessed at 5 time points ranging from pre-treatment to 12-month follow-up. The conditions~     will be compared in terms of treatment efficacy and mechanisms. The investigators will also~     examine the predictors of change during the 12-months following treatment. The proposed study~     will produce data on the efficacy and mechanisms of a treatment for GAD that is less costly,~     less complex and easier to disseminate than treatments that are currently available.~   "
77536|NCT02552095|"~     The Purpose of this study is to evaluate compatibility of the Triathlon Partial Knee~     Replacement (PKR) with the Japanese population. It is expected that patients who receive the~     Triathlon PKR will achieve excellent clinical results without adverse effects and that the~     device fits well with Japanese morphology.~   "
77537|NCT02552082|"~     The purpose of this study is to evaluate the range of motion (ROM), mid-flexion stability~     (gap balance), and implant position (size and angle) for the Scorpio NRG device. Relationship~     between these parameters and clinical outcomes will be evaluated as well as the importance of~     rotational tolerance. It is expected that the Scorpio NRG will have good clinical outcomes~     and perform the same or better than other total knee implants.~   "
77538|NCT02552069|"~     The purpose of this study is to evaluate early fixation and stability of the Tritanium cup.~     It is expected that the Tritanium® cup will be equal to or better than conventional~     cementless cups in early fixation/stability and meet the expectations of Japanese surgeons.~   "
77539|NCT02552056|"~     This randomized controlled trial will compare the effect of a CAMH integration package on~     yield of CAMH cases compared to non-CAMH integrated sites. It will be conducted among nurses,~     midwives and clinical officers who provide PHC services to children and adolescents in 42~     health centers; and eligible traditional healers.~   "
77540|NCT02552043|"~     The aim of this study is to evaluate the efficacy of a long-term domiciliary exercise program~     using the Wii video game platform as a training modality in Cystic Fibrosis (CF) patients.~     Investigators hypothesize that an exercise program performed by active videogames (AVG) will~     produce an improvement in exercise tolerance and muscular strength to be maintained over time~     in young CF patients.~   "
77541|NCT02552030|"~     In this Trial we compare a new application (App) running on an iPhone (Apple inc., Model 4S)~     to determine systolic blood pressure (RR) and compare it to conventional oscillometric~     measurements using an Omron HBP-1300-E Pro device. We will include 1000 participants and~     perform seven repetitive blood pressure measurements (3 iPhone, 4 Omron) in each person.~     Primary parameter will be the absolute difference (Delta) between the correlating blood~     pressure measurements in mmHg.~   "
77542|NCT02552017|"~     The purpose of this study is to determine if a new device, called the Endocuff Vision (a~     small plastic device attached to the end of the colonoscope which helps by holding the folds~     of the bowel back to give a clear view of the inside of the bowel) will significantly improve~     the detection of adenomas when used in all patients referred for colonoscopy.~   "
77543|NCT02552004|"~     Intraoperative histological examination is a fundamental tool in surgery. Probe-based~     Confocal Laser Endomicroscopy (pCLE) is a new imaging technique which enables real-time,~     microscope-resolution imaging, currently used in endoscopy. This pilot study aims to evaluate~     pCLE in surgical setting. The objective is the depiction of histological rendering of normal~     and pathological tissues through pCLE. Feasibility of real-time diagnosis will also be~     assessed. All surgical conditions usually necessitating frozen section will be investigated.~     A total of 30 patients, with various pathology of the thyroid / parathyroid, stomach,~     esophagus, pancreas, adrenal, colon / small intestine, liver will be included. Diagnostic~     criteria will be defined by a surgeon - pathologist team and further validated by~     retrospective analysis of the video sequences in comparison to conventional histology slides.~     The data will be used to create an image bank of reference optical biopsy images. The study~     will allow to point out the surgical conditions in which pCLE is the most effective and~     reliable and could eventually replace the frozen section technique.~   "
77555|NCT02551848|"~     The primary objective is to study the efficacy of botulinum toxin type A (Xeomin®) injected~     utilizing kinematically-based injection parameters for the treatment of upper extremity~     essential tremor (ET). Additional objectives are to study the benefit of kinematic assessment~     tools in determining injection parameters and to study the composition of tremor using~     kinematics.~   "
77544|NCT02551991|"~     This is an open-label, phase 2 comparative study to assess the safety, tolerability, and~     efficacy of nal-IRI in combination with other anticancer therapies, compared to~     nab-paclitaxel + gemcitabine, in patients with advanced pancreatic adenocarcinoma who have~     not received prior chemotherapy. This study will assess the following regimens:~        -  nal-IRI + 5-FU/LV + oxaliplatin~        -  nal-IRI + 5-FU/LV~        -  nab-paclitaxel + gemcitabine~      The study will be conducted in two parts:~        1. Part 1: a safety run-in (initial dose exploration followed by dose expansion) of the~          nal-IRI + 5-FU/LV + oxaliplatin regimen, and~        2. Part 2: a randomized, efficacy study of nal-IRI + 5-FU/LV + oxaliplatin, and nal-IRI +~          5-FU/LV, versus nab-paclitaxel + gemcitabine.~   "
77545|NCT02551978|"~     Obesity and its associated comorbidities are becoming a key and rapidly growing public health~     problem. The cause of obesity is an imbalance between energy intake and energy expenditure in~     favor of the former. Childhood and adolescence are seen as critical time for its development.~     It is therefore crucial to provide both prevention and treatment actions already during~     childhood. The prevention and treatment weight-management programs in children focus on~     improving diet, eating behaviours, psychosocial aspects and increasing physical activity. One~     important basic requirement for any weight-management program is, that both children and~     their families are motivated and ready for change. Video games, including exergames, serious~     games or combined approaches offer additional chances in the treatment and prevention of~     obesity by approaching children in their environment and motivating them to deal with~     life-style topics.~      The investigators developed a motion-controlled serious game for children aged between 9 and~     12 years, addressing all the three core areas nutrition, physical activity, and psychosocial~     factors. In addition to the motion control, a tablet is used for knowledge-based and~     cognitive tasks. In comparison to other studies the nutrition part not only deals with the~     food pyramid but also with the energy density of foods and liquids and offers a~     self-reflexive diagnostic tool to analyse daily food intake. Moreover, psychological aspects,~     especially stress and stress-coping strategies are addressed e.g. by relaxation-exercises.~     The game consists of two sessions, having each a duration of about 35 minutes.~      The aim of this study is to evaluate the program in a cluster-randomized controlled trial in~     a primary school setting in children aged 9 to 12 years. Therefore, six 4th grade classes of~     the same school will be randomly allocated to an intervention and a control group. The~     intervention group will play the game within two weeks, whereas the control group will~     receive basic information. At baseline, two weeks after baseline and at four weeks follow-up,~     measurements will be performed. The primary outcome of the study is the gain of knowledge~     (nutrition, psychosocial aspects) measured by a self-constructed questionnaires tailored~     specifically for the serious game. Secondary outcomes are the acceptance of the game, changes~     of nutrition behaviour, physical activity and intentions of the children to follow a healthy~     lifestyle, measured by mostly validated questionnaires.~   "
77546|NCT02551965|"~     In geriatric oncology, caregivers are submitted to a risk of exhaustion. To investigate the~     clinical risk factor of exhaustion, the researchers propose to conduct a prospective~     observational study during 6 months phone follow up of the caregivers. The recruitment will~     take place during the oncogeriatric assessment consultation.~   "
77547|NCT02551952|"~     INTRODUCTION: Cognitive dysfunction is a frequent adverse event in the postoperative period,~     especially in elderly patients. The tests commonly used for the detection of postoperative~     cognitive dysfunction are time-consuming and with variable sensitivity and specificity and~     difficult routine use. Applying a difficult battery of cognitive tests decreases the~     viability of adopting measures to increase preoperative cognitive reserve and methods for~     prevention, diagnosis and rehabilitation of cases of Postoperative Cognitive Dysfunction~     (POCD), it is desirable to search for alternative methods diagnoses.~   "
77548|NCT02551939|"~     A total of 38 Chinese healthy women underwent autologous fat grafting for cosmetic breast~     augmentation. Breast volumes were measured by magnetic resonance imaging preoperatively and 1~     year after the procedure. Furthermore, BREAST-Q was used to analyze the satisfaction and~     well-being of patients during the preoperative and 1 year post operation.~   "
77549|NCT02551926|"~     Prehypertension is a predisposing condition for morbidity inhypertension and cardiovascular~     diseases. Health education via electronic pathways such as mobile text messaging or virtual~     communities may provide more availability and adherence than printed media. Regarding lower~     costs of such electronic resources and continuity of interventions through these ways,~     assessing their effectiveness compared to a printed material may help health educators to~     choose proper methods for improve their educational attempts. Therefore, the current study~     aims to compare different tools for health education about healthy lifestyle in people with~     prehypertension. For this, educational interventions with similar content among 3 groups of~     people will be conducted (i.e., first group via mobile text messaging, second group using~     virtual communities, and third group by brochures as a printed media). A control group also~     will be considered without any intervention. Several phases are considered in the study. In~     phase 1 using health centers located in Qazvin city, people would be invited to a free~     screening program of prehypertension. Then, an eligible sample will be divided in three~     groups using a random allocation process (each one including 100-150 people with~     prehypertension). The blood pressure and health promotion lifestyle profile II (HPLP II) will~     be measured before intervention. A standard educational content using approaches of lifestyle~     promotion defined in HPLP II would be available for intervention groups during a time period~     of 1 month concurrently. At final phase, one month after termination of intervention blood~     pressure as primary outcome and lifestyle changes along with self-efficacy for lifestyle~     modification as secondary outcomes will be measured. This study may suggest effective ways~     for health education which is applicable by health care professionals to promote health~     status among peopleat risk of hypertension.~   "
77550|NCT02551913|"~     Sleep education has been used as a method of primary and secondary prevention of sleep~     problems in all age groups. An especially vulnerable age group are adolescents who frequently~     have poor sleep habits and suffer from sleep deprivation. In adolescents, insufficient sleep,~     inadequate sleep quality, and irregular sleep patterns are associated with daytime~     sleepiness, negative moods, increased likelihood of stimulant use, higher levels of~     risk-taking behavior, poor school performance, and increased risk of unintentional injuries.~     As an US study has shown, sleepiness was the major causal factor in many traffic accidents~     and more than 50% of sleep-related crashes involved drivers aged 25 or younger. The study was~     aimed to evaluate the effectiveness of a theory-based sleep hygiene intervention in improving~     sleep quality in adolescents.~   "
77551|NCT02551900|"~     Warm water based cycling exercise training would more favorable than cold water based cycling~     exercise training and land based cycling exercise in vascular function in type 2 diabetic~     patients.~   "
77552|NCT02551887|"~     Primary, Secondary, and Exploratory Objective(s):~      Primary objective: To evaluate the effect of interventions on 1st dose uptake of HPV vaccine.~   "
77553|NCT02551874|"~     This research study of subjects with inadequately controlled type 2 diabetes mellitus (T2DM)~     will compare the glycemic control (measured by HbA1c) in subjects co-administered saxagliptin~     and dapagliflozin, in addition to metformin with or without sulfonylurea, to subjects~     receiving insulin glargine, in addition to metformin with or without sulfonylurea, over a~     treatment period of 52 weeks.~   "
77554|NCT02551861|"~     The purpose of this study is to determine if 8 weeks of Daclatasvir plus Sofosbuvir with or~     without Ribavirin is safe and effective in the treatment of genotype 3 hepatitis C infected~     patients without advanced fibrosis or liver cirrhosis who have never been treated previously.~   "
78650|NCT02537444|"~     To characterize the safety and efficacy of acalabrutinib (ACP-196) monotherapy and~     acalabrutinib plus pembrolizumab combination therapy in subjects with recurrent ovarian~     cancer~   "
77556|NCT02551835|"~     This meta-analysis will be conducted to study the effect on vitamin D supplements on markers~     for cardiovascular disease and diabetes using individual participant data from 12 RCTs. Given~     that previous data suggest that vitamin D supplementation might be most effective in those~     individuals with very low 25-hydroxyvitamin D (25(OH)D) and potentially harmful in those~     achieving very high levels after vitamin D supplementation, this meta-analyses will be~     performed in subgroups according 25(OH)D levels.~   "
77557|NCT02551822|"~     The investigators objective is to compare patient outcomes as changes in validated symptom~     measures of overactive bladder, the Overactive Bladder Questionnaire Short Form (OABq-SF)~     symptom scale, between women who are set on cycling versus continuous programs for their~     neuromodulator. Specifically, the investigators propose to perform a randomized double blind~     crossover study in women who are successfully treated with neuromodulation to either~     continuous or cycling mode on the modulator and compare differences between groups on the~     validated OABq-SF symptom questionnaire. In addition, the investigators will compare~     differences in urinary frequency and pad counts between women randomized to cycling versus~     continuous stimulation as measured by a 3 day voiding diary. This investigation will provide~     evidence-based guidelines for neuromodulator programming.~   "
77558|NCT02551809|"~     The purpose of this Phase IIa study is to determine whether the AD Immunotherapeutic Vaccine~     (UB-311), targeting the amyloid beta peptide (N-terminal amino acids, 1-14), is safe and~     immunogenic in mild AD patients. In addition, the efficacy profiles will be evaluated as the~     secondary endpoint.~   "
77559|NCT02551796|"~     To evaluate the short-term changes in ocular surface measures and tear inflammatory mediators~     after lenticule extraction (FLEx), laser in situ keratomileusis (LASIK) and femtosecond~     laser-assisted laser in situ keratomileusis (FS-LASIK) procedures.~   "
77560|NCT02551783|"~     This is a randomized non-blinded comparison of dorsal vs. ventral approach for buccal mucosa~     graft urethroplasty in the bulbar urethra. Buccal mucosa graft is a common method of~     repairing the strictured urethra. Current evidence suggests the two approaches for placement~     of the graft are equally successful at correcting the stricture and the two approaches have~     similar risks of complications. The investigators propose to randomly assign appropriately~     selected patients to either a dorsally- or ventrally-placed graft. No additional procedures~     beyond the normal care protocol will be required of the patients. Success will be assessed~     via objective and subjective methods; complications will be tallied in a standardized~     fashion. Outcomes will be measured at two years.~   "
77561|NCT02551770|"~     The aim of this controlled study is to assess the clinical outcomes and patient reported~     outcomes of using minimally invasive surgical procedure with Straumann Emdogain as an adjunct~     (test treatment) or without Straumann Emdogain (control treatment).~   "
77562|NCT02551757|"~     The purpose of this study is to assess the effect of continuous positive airway pressure~     (CPAP) on functional outcome in patients with acute stroke, the investigators conducted a~     sham-controlled, double-blind pilot trial during inpatient rehabilitation.~      Patients with acute stroke were recruited and randomly assigned to auto-titrating or~     sham-CPAP during their rehabilitation stay.~   "
77563|NCT02551744|"~     Whether pantoprazole versus famotidine for the prevention of recurrent peptic ulcers in~     thienopyridine users remains unclear.~   "
77564|NCT02551731|"~     Infantile Spasms (IS) is a diagnosis described as a fairly rare and terrible form of epilepsy~     that usually strikes children in the first year of life. There is a great need for safe and~     effective therapies in the treatment of IS. This need is even more important for infants and~     toddlers still sick after being treated with medicine that is already available.~      This is a multi-center study to evaluate the efficacy and safety of Cannabidiol Oral Solution~     (COS) in the treatment of children aged 6 months through 36 months with a diagnosis of~     infantile spasms who have not responded to first line therapies.~      The overall study duration is expected to be 64 weeks for those subjects who respond to COS~     treatment. The maximum possible study duration for each patient is approximately 64 weeks,~     however a subject will be deemed to have completed the study after 58 weeks.~   "
77565|NCT02551718|"~     This pilot clinical trial studies the feasibility of choosing treatment based on a high~     throughput ex vivo drug sensitivity assay in combination with mutation analysis for patients~     with acute leukemia that has returned after a period of improvement or does not respond to~     treatment. A high throughput screening assay tests many different drugs individually or in~     combination that kill leukemia cells in tiny chambers at the same time. High throughput drug~     sensitivity assay and mutation analysis may help guide the choice most effective for an~     individual's acute leukemia.~   "
77566|NCT02551705|"~     Huntington's disease (HD) is a genetic progressive fatal neurodegenerative disorder. In the~     western world it affects 5-10 persons per 100000. The main brain changes include the loss of~     brain cells in subcortical structures. The symptoms of HD include involuntary movements,~     cognitive deterioration and behavioural disturbances. It has been shown that changes in~     emotion comprehension occur before the onset of the motor symptoms (preHD). This deficit in~     perception of emotions has been primarily investigated by means of facial expressions.~     However, emotions can also be expressed through body language. Here, the investigators~     propose to investigate whether the emotion comprehension deficit in preHD also includes body~     language comprehension.~   "
77567|NCT02551692|"~     The goal of this study is to evaluate the effects of varenicline versus nicotine replacement~     versus placebo on personal smoking environment cue (PSE) reactivity. The results of this~     study will inform whether first-line pharmacotherapies for nicotine dependence (e.g. nicotine~     patch, varenicline) alter reactivity to environment cues. The investigators propose to~     identify 120 regular cigarette smokers who will complete 10 visits (1 screening visit, 1~     training visit, 1 camera turn-in 2 cue exposure sessions and 4 post-quit medication check~     sessions). Smokers will be randomized to one of three medication conditions: placebo (PLAC;~     n=40), transdermal nicotine patch (NRT; n=40) or varenicline (VAR; n=40) in a double blind,~     double-dummy design. Reactivity variables (craving, latency to smoke, and smoke intake) will~     be entered into 3 (Medication: NRT, VAR, PLAC) x 2 (Environment: smoking, nonsmoking)~     repeated measures ANOVAs with random-effects. The investigators hypothesize that personal~     smoking, as compared to nonsmoking environments, will be associated with greater reactivity~     (i.e. increased craving and smoke intake; decreased latency to smoke). A Medication x~     Environment interaction will be characterized by decreased reactivity to smoking as compared~     to nonsmoking environments in the VAR and NRT groups as compared to the PLAC group.~   "
77569|NCT02551666|"~     The goal of this translational research study is to evaluate the efficacy and feasibility of~     balance recovery training as an on-site fall prevention exercise intervention for older~     adults living in retirement communities. Falls are the leading cause of injuries and~     injury-related deaths among older adults over the age of 65 in the United States. While it is~     generally accepted that exercise helps prevent falls, exercise does not always reduce the~     number of falls, and it remains unclear which types of exercise are most effective at~     preventing falls. Balance recovery training (BRT) is a novel exercise intervention that has~     that has the potential to decrease the number of falls among older adults by improving their~     balance recovery ability after common balance perturbations such as tripping. BRT involves~     repeatedly exposing individuals to postural perturbations in a safe, controlled setting that~     allows reactive balance recovery to be practiced and improved. The investigators will~     administer BRT on-site at continuing care retirement communities over four weeks to older~     adult fallers and determine its effects on balance recovery ability over the following six~     months compared to another group of older adult fallers performing Tai Chi as an alternative~     exercise intervention. To further address the potential for BRT to be translated into typical~     practice within retirement communities, the investigators will also collect data on~     facilitators and barriers to the long-term sustainability of BRT in retirement communities~     using qualitative methods. These quantitative (balance recovery ability) and qualitative~     (implementation process) measures will provide the basis for a subsequent large practical~     clinical trial to test the effectiveness of BRT on reducing the number of falls among older~     adults.~   "
77570|NCT02551653|"~     Pulmonary arterial hypertension (PAH) involves the narrowing of blood vessels connected to~     and within the lungs. Focal adhesion kinase (FAK) is a focal adhesion-associated protein~     kinase involved in cellular adhesion and spreading processes which leads to stiffening and~     thickening of blood vessels in lungs. This further increases the blood pressure within the~     lungs and impairs their blood flow. This study aims to demonstrate biodistribution of FAK~     inhibitor, GSK2256098, in cardiopulmonary sites i.e. heart and lung tissues. The uptake of~     11C-radiolabelled GSK2256098 within the lung and / or heart of healthy subjects and~     idiopathic pulmonary arterial hypertension (iPAH) patients will be assessed using Positron~     Emission Tomography (PET). Based on study results the decision as to whether a follow-on~     phase 2 trial should be initiated to investigate the therapeutic utility of GSK2256098 in~     iPAH will be decided. Sufficient number of subjects will be screened (up to 30 days prior to~     scan) to enrol 12 healthy subjects and 12 PAH patients in the study. Enrolled subjects will~     receive a microdose of [11C]-GSK2256098 on a scanning day which will be followed by the~     follow-up visit (2-4 weeks post-last dose).~   "
77571|NCT02551640|"~     The goal of this study is to explore the effects of FeatForward on physical activity and~     cardio-metabolic risk factors. The study will be implemented as a 2-arm randomized controlled~     trial (RCT) comparing the effects of FeatForward in patients assigned to use the application~     versus a control group who will not use the app over a 6-month follow-up period. The~     investigators hypothesize that subjects using FeatForward will be more physically active and~     will achieve greater improvements in their cardio-metabolic risk (CMR) factors than a usual~     care control group that will not use the app over a 6-month period.~   "
77572|NCT02551627|"~     This will be a double blind, two-arm, parallel-group, stratified for gender, randomised,~     controlled study in participants aged 7-10 years (yrs). The aim of the study is to test the~     hypothesis that MMN fortified beverage may help improve immunity outcomes as assessed through~     vaccine response in 7-10 yrs old school participants.~   "
77573|NCT02551614|"~     This is an exploratory study to further develop an imaging platform for the assessment of~     whole lung neutrophil retention. The primary objective of the study is to quantify and~     compare neutrophil retention in the lungs of lipopolysaccharide-challenged healthy subjects,~     saline-challenged healthy subjects and subjects with stable COPD. There will be two treatment~     groups, one with healthy subjects and the other with subjects with stable COPD. The total~     duration of this study for healthy subjects will be approximately 1 week, in addition to the~     screening window of 28 days. The total duration of this study for subjects with COPD will be~     approximately 1 week for those that complete Visit 1 only, and approximately 2 weeks for~     those subjects with COPD that return to the unit for Visit 2 7-10 days later, in addition to~     the screening window of 28 days.~   "
77574|NCT02551601|"~     The purpose of this study was to determine the subfoveal choroidal thickness in normal Thai~     eyes and study the associations with gender, age, refractive error and axial length using~     spectral-domain optical coherence tomography with enhanced depth imaging technique.~   "
77575|NCT02551588|"~     Aortic valve stenosis (AVS) is the most frequent valvular disease. The severity of the~     obstruction of the left ventricle (LV) is essentially analyzed today by echocardiography~     Doppler, which assesses two key markers that are aortic valve pressure gradient and the~     aortic valve area. however these marker are a poor reflect of the clinical severity of AVS.~     The aim of the study is to validate new markers assessing cardiac fibrosis that might best or~     complementary markers.~   "
77576|NCT02551575|"~     This is prospective randomized, controlled study to evaluate the efficacy and safety of~     Qingre Huoxue comprehensive therapy in treating of patients with early Rheumatoid Arthritis~     (RA). The major outcome index is the change from baseline to week 24 in Disease Activity~     Score (DAS28), and minor outcome indexes include American College of Rheumatology~     (ACR)20/50/70, PRO score, Sharp score and OMERACT RAMRIS score. The adverse events at any~     time were recorded to evaluate the safety.~   "
77585|NCT02551458|"~     Step 1: Inclusion of eligible patients to carry out a translational search for prognostic and~     predictive markers of Complete Clinical Response and Pathologic Complete Response (using~     blood samples and diagnostic biopsies) and to collect data on radiochemotherapy and its~     toxicity.~      The trial will evaluate strategies after neoadjuvant treatment and not RCT protocols. The RCT~     will thus be chosen by the investigator from published effective schemes in a pre-operative~     setting or in patients not undergoing surgery.~      Evaluation of the response 5 to 6 weeks after the RCT.~      Step 2: Randomisation in patients with a complete clinical response:~      Arm A: Systematic surgery Arm B: Surveillance and rescue surgery in cases with resectable~     loco-regional recurrence~      Patients not eligible for randomisation will have the possibility to participate in a~     specific study (information can be obtained from the SAKK group (Switzerland Group Clinical~     Research on Cancer)).~   "
77577|NCT02551562|"~     20 female subjects, between the ages of 25 and 60, who request a full facial rejuvenation~     treatment, meet all the inclusion and none of the exclusion criteria, and have signed a~     written informed consent, will be enrolled. Subjects will be divided randomly into two~     treatment groups:~        1. Group A: subjects will use a basic skin care regime following a full facial rejuvenation~          with hyaluronic acid soft-tissue filler and botulinum neurotoxin.~        2. Group B: subjects will use the Nu-Derm® system following a full facial rejuvenation with~          hyaluronic acid soft-tissue filler and botulinum neurotoxin.~      The study consists of 5 visits: Baseline/Screening Assessments (Visit 1), Treatment (Visit~     2), Two-Week Evaluation (Visit 3), Six-Week Evaluation (Visit 4), and Twelve-Week Evaluation~     (Visit 5).~      Changes in the subjects' quality of skin will be determined by the PI's assessment of skin~     tone (dyschromia), elasticity (firmness), texture (smoothness), radiance, and wrinkling as~     well as the global aesthetic improvement at 6 and 12 weeks following neurotoxin and~     hyaluronic acid treatments. The PI will be blind to the group assignment of the subjects.~      Subjects' satisfaction with treatments and their quality of skin will be determined through a~     self-evaluation at 6 and 12 weeks following neurotoxin and hyaluronic acid treatments. The~     impact of treatments on subjects' state self-esteem will also be assessed at 6 and 12 weeks~     following the treatments.~   "
77578|NCT02551549|"~     A multiple ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of~     CD101 Injection in Healthy Subjects.~   "
77579|NCT02551536|"~     Objectives: Allergic Rhinitis (AR) is a global health problem. 10-25% of population worldwide~     is affected by AR. Oral/intranasal H1-antihistamine, decongestants, leukotriene receptor~     antagonists, intranasal corticosteroids are the pillars in the management of AR.Materials and~     methods: Seventy patients with allergic rhinitis participated in a prospective, randomized,~     double-blind, parallel, active controlled, comparative 4 week trial. The patients between age~     group of 18-65 years of either gender having moderate-severe intermittent or mild persistent~     allergic rhinitis were included. The study inclusion criteria required the subjects with~     Total Nasal Symptom Score (TNSS) of 5 or higher. The patients were randomly divided into two~     treatment groups with montelukast-levocetrizine (10 mg and 5 mg) in one group and~     montelukast-fexofenadine (10 mg and 120 mg) in another group. TNSS parameter was the main~     effectiveness parameter.~   "
77580|NCT02551523|"~     Long term toxicity of combination antiretroviral therapy (cART) is a substantial contributor~     to morbidity and mortality in chronically infected HIV positive individuals. To date it is~     still debated, whether long term nucleoside reverse transcriptase inhibitors (NRTI's)~     -sparing regimens are practicable or even superior compared to standard of care cART in terms~     of efficacy, safety and tolerability. In addition, data about efficacy of integrase inhibitor~     (INSTI) based monotherapy is lacking. We aim at investigating the efficacy of standard of~     care combination antiretroviral therapy with a simplified dolutegravir monotherapy in~     patients with a primary HIV-1 infection under suppressive early standard of care~     antiretroviral therapy. Briefly, hundred-thirty-eight patients with a documented primary~     HIV1- infection (PHI) will be recruited from the Zurich Primary HIV-1 Infection Study (ZHPI),~     which is an open label, non-randomized, observational, single-center study~     (http://clinicaltrials.gov, ID 5 NCT00537966). All subjects formerly underwent early cART~     consisting of either a protease inhibitor (PI) or a non-nucleoside reverse transcriptase~     inhibitor (NNRTI) or a INSTI in combination with two NRTIs at the time point of enrolment in~     the ZPHI and must be under a fully suppressive ART (i.e., <50 copies/ml) for at least 48~     weeks at the time point of randomisation. The primary end point is the proportion of~     individuals with a viral failure at week 48 or before.~   "
77581|NCT02551510|"~     Port Wound Closure compares synthetic tissue adhesives with seam for cutaneous wound closure~     to port plant in terms of cosmetic results and time savings at comparable risk for wound~     infection.~   "
77582|NCT02551497|"~     This is a double-blind, randomised, placebo-controlled 3 period study to evaluate the~     interaction between a drug and CNV1014802 in healthy male and female subjects. It is planned~     to enrol 36 subjects.~   "
77583|NCT02551484|"~     50 patients will be included for each of the 2 procedures:~      - For procedure 1: Patients will be selected during multidisciplinary consultations for~     amputees who are stabilized with their definitive prosthesis and have returned to their usual~     place of residence. The aim of this procedure is to show the validity and reproducibility of~     measurements of tissue oxygenation using NIRS (TcPO2 being the reference measurement), to~     determine the way in which NIRS measurements are more precise (i.e. in terms of validity and~     reproductibility) (values at rest with the patient lying perfectly flat or with the amputated~     limb raised 30°). These patients will require a single visit which will include measurements~     by NIRS and TCPO2, a walk test and the completion of 2 questionnaires (visual scale).~      - For procedure 2: The patients will be included in the initial phase of postamputation~     rehabilitation, during the period of in-hospital rehabilitation. The main problems of healing~     and tolerance to the temporary prosthesis arise during this phase. The specific objectives~     will be: To show that measurement by NIRS predicts the quality of healing in trans-tibial~     amputees; to show that the zone of uncertainty concerning the predictive values for the~     viability of the stump is smaller with NIRS than with TcPO2 (better discrimination). NIRS and~     TCPO2 measurements as well as the evaluation of stump healing will be done 15, 30 and 45 days~     after the amputation.~   "
77584|NCT02551471|"~     The incidence of rectal cancers is at 15,000 new cases per year in France of which 10 to 15%~     are locally advanced (T4bNxM0) at the moment of diagnosis. The rate of invaded resection~     margins (R1) for these locally advanced and fixed rectal tumours varies from 10 to 20%. The~     invasion of the resection margins triples the risk of local recurrence. In the absence of~     surgical treatment, the 5-year survival rate for patients having had pelvic recurrence of~     rectal cancer is lower than 4% whereas it varies from 35 to 40% in cases of curative~     resection. The care and management of locally advanced and fixed rectal tumours and pelvic~     recurrence of rectal cancer constitutes, therefore, in the absence of recommendation, a~     difficult therapeutic problem with great variability in the methods of care and management~     around the world. These variations in practice can be explained by structural and~     organizational differences, as well as cultural dissimilarities. With regards to the~     organization of its healthcare system, Australia is shown to be a leader as regards the care~     and management of locally advanced and fixed rectal tumours and pelvic recurrence of rectal~     cancer.~   "
77586|NCT02551445|"~     This study involves people with eating disorders and healthy volunteers (people who have~     never experienced an eating disorder). Participants are interviewed about their psychological~     and physical health by the experimenter and they have a simulated scan session (about 1~     hour). Approximately 1 week after they attend the first study session. They are asked to~     complete questionnaires and computerized tasks (about 30 minutes) followed by the active scan~     (1 hour). During the brain scan they look at pictures and answer questions about the~     pictures. After the first study session, people with eating disorders receive an intensive~     meal-support intervention (in the following 3 months) aimed at reducing anxiety and fears~     related to food (10 sessions lasting about 60 min.). Three months after the first brain scan,~     participants with eating disorders and healthy controls receive a second assessment and brain~     scan. We hypothesized that the meal support intervention will be effective in: 1) targeting~     eating disorder symptoms (body mass index - BMI, primarily) and 2) producing functional~     changes in brain regions that underline food-related anxiety and avoidance.~   "
77587|NCT02551432|"~     Patients with refractory SCLC. Patients will be treated with paclitaxel and pembrolizumab.~   "
77588|NCT02551419|"~     A six month, placebo-controlled, parallel group project in which MCI participants will~     receive 30 g/day of a custom-made MCT-based ketogenic supplement or a matching placebo.~     Uptake of both the brain's fuels - ketones (as 11C-AcAc) and glucose (as FDG) - both before~     and after the intervention will be assessed by PET (position emission tomography) imaging, as~     well as fMRI, diffusion MRI and cognition.~   "
77589|NCT02551406|"~     Different tools may be used to monitor the efficacy of home mechanical ventilation.~     Investigators aimed to compare the prognostic value of the different data obtained by~     capno-oxymetry in a mechanical ventilated neuromuscular disease's population.~   "
77590|NCT02551393|"~     Clinical Trial: The investigators aims at comparing providing validated home BP device,~     followed by group education of self-management of hypertension as well as self-BP monitoring~     and appropriate medication in response to home BP reading, followed by nurse follow up with~     usual care, which may possibly improve older adults with uncontrolled hypertensions drug~     adherence, and therefore improve their BP level in primary care setting. The investigators~     will invite total 270 patients from 6 general outpatient clinic (GOPCs) to participate the~     trial.~      Qualitative study: The investigators would also like to evaluate patients' view and~     operational concerns on self BP monitoring by individually interviewing 30 selected patients~     from intervention group~   "
77591|NCT02551380|"~     The investigator planned to study the efficiency of folinic acid treatment on autistic~     symptoms in children suffering from autism spectrum disorder.~   "
77592|NCT02551367|"~     110 infertile women diagnosed as polycystic ovary syndrome (PCOS) at the age group of 20-35~     distributed randomly :~        -  55 women will receive letrozole 2.5mg twice daily orally from the 2nd day to the 6thday~          of the cycle for three successive cycles.~        -  55 women will receive clomiphene citrate 50 mg twice daily orally from the 2nd day to~          the 6thday of the cycle for three successive cycles.~      Patients will be subjected to:~      Complete history taking:~        1. Details about name, age~        2. Menstrual history with determination of menarche~        3. Amenorrhea or oligomenorrhea , Regularity of the cycle~        4. History of endocrine disease.~        5. History of previous operations.~             -  Physical examination:~             -  General examination:~           With special concern to:~           --Acne.~           --Hirsutism .~           --Weight.~           --Height~           --BMI was determined :~           Wt. in kg ـــــــــــــــــــ =~           ) Height in m)2~           - Abdominal examination :~             -  for scar of previous pelvic or abdominal operations .~                  -  Pelvic examination :~             -  vaginal examination for enlarged cystic ovaries.~                  -  ultrasound for diagnosis of pcos.~           PARAMETERS:~      (1) rate of ovulation (primary parameter). (2) serum progesterone level on day 21. (3) number~     of mature follicles produced per cycle. (4) mean endometrial thickness. (6) chemical~     pregnancy. (7) ongoing pregnancy~   "
77593|NCT02551354|"~     Epidural regional anesthesia is a technique to eliminate or lessen pain during obstetric~     labor and childbirth. It consists in establishing a catheter into the epidural space and to~     block the transmission of pain sensations by injecting a local anesthetic and an opioid. In~     10-25% of cases the epidural does not give perfect results, causing it to test its~     effectiveness, which is mainly done by questioning the patient on mitigation or disappearance~     of pain. This collaboration of patients is sometimes limited in our care structure by the~     inability to assess or express the pain, mainly due to cultural differences or language~     barriers, which can represent up to 15% of women in our institution. This led to develop~     objective measures of pain techniques used at the bedside.~      Pupil diameter (PD) varies under the double influence of sympathetic system (Σ), dilator of~     the pupil, and parasympathetic system (pΣ).~      The PD increases in response to painful stimulation, in proportion to the intensity of the~     nociceptive stimulus. This variation of PD has been proposed as a means of evaluation of pain~     in patients under general anesthesia, but has been little studied in conscious subjects.~      There are other permanent changes in the PD, due to constant interaction between Σ and pΣ~     systems. Few data have been published to date on this PD variability (PDV).~   "
77594|NCT02551341|"~     Randomized study investigating the effects of lung protective ventilation (PEEP), as compared~     with normal ventilation (ZEEP) on lung function, treatment of the renal sodium and water,~     vasoactive hormones, biomarkers of nephrotoxicity, and the circulation of patients undergoing~     assisted robotic radical prostatectomy~   "
77595|NCT02551328|"~     The main aim of this study is to compare markers of cardiac injury (Troponin I), inflammatory~     response and platelets function during minimally invasive mitral valve repair or replacement~     (MIMV) via right mini-thoracotomy in two standard anaesthetic regimes (sevo \propofol)~   "
77596|NCT02551315|"~     This multicenter, prospective, observational cohort study will assess bone differences in~     women and men with type 2 diabetes mellitus (T2DM) with and without fragility fractures.~   "
77597|NCT02551302|"~     Effectiveness of hybrid systems (topping off) compared to rigid spondylodesis in fusion~     surgery of the lumbar spine: A prospective, randomized, bicentric pilot study (CD HORIZON~     BalanC™)~   "
77609|NCT02551146|"~     The aim of this study is to assess the influence of this particular treatment method on the~     patients' quality of life and masticatory function.~   "
77598|NCT02551289|"~     One in 100 people suffers from coeliac disease. It affects the lining of the bowel and causes~     many symptoms such as diarrhoea, wind, stomach pain, constipation and nausea. The only~     treatment so far is a strict glutenfree diet for life which reverses the bowel damage and~     often improves symptoms. Up to 25% of patients however may have persistent symptoms despite~     the gluten free diet but the reasons for this are not clear.~      This research aims to help us understand how the gluten free diet works. Investigators will~     use medical imaging (magnetic resonance imaging or MRI) to measure the volumes of fluid in~     the small bowel, the size of the large bowel and the time it takes for foods to go through~     the entire bowel in patients who have just been diagnosed with coeliac disease by their~     hospital doctor. Investigators will also carry out a breath test and collect a stool sample~     for basic analysis of the stool bacteria.~      Investigators will also collect questionnaires about their feelings and their bowel habits~     and will try to see how the MRI measurements relate to the patients' symptoms. Investigators~     will observe how all these measures change after one year of the gluten free diet that~     doctors will have prescribed as part of the coeliac patients' standard care. As such there is~     no dietary intervention in this study, investigators will simply study changes in the~     patients due to their standard treatment. Investigators will also look at a matched group of~     healthy volunteers to gather a likely reference range of the measurements. This research will~     be carried out in Nottingham with the help of the specialist coeliac clinics and it will last~     3 years. There is a dedicated Coeliac Patient Public Involvement group who have helped plan~     this study.~   "
77599|NCT02551276|"~     Studies in animals have shown that beta2-adrenoceptor activation with selective agonists~     regulates protein metabolism and muscle growth in skeletal and cardiac muscle tissue. These~     effects may be mediated by cAMP/PKA dependent activation of several downstream sites that~     modulate protein synthesis and breakdown. While the role of beta2-adrenoceptor signaling is~     well-described in animals, it is inadequately explored in humans. The purpose of the study is~     thus to investigate the effect of chronic beta2-adrenergic stimulation (cAMP/PKA-signaling)~     on muscle hypertrophy.~   "
77600|NCT02551263|"~     This is a observational study in a real-world setting, not requiring determining a dosage~     regimen, dose reduction criteria, rest period criteria and withdrawal criteria. The purpose~     of the study is to investigate the efficacy of eribulin as the first or second line~     chemotherapy to prolong overall survival and to explore factors affecting the survival in~     patients with HER2-negative hormone-resistant inoperable or recurrent metastatic breast~     cancer who scheduled to receive the first or second line chemotherapy in clinical practice in~     Japan. The total duration of the study will be a maximum of 5 years, consisting of 2-year~     enrollment period and 3-year observational period; the duration of patient participation will~     be 3 years. All patients will receive adequate treatment for breast cancer which selected by~     the primary physician after enrollment using the Japanese Breast Cancer Society Clinical~     Practice Guideline of Breast Cancer and the National Comprehensive Cancer Network (NCCN)~     Clinical Practice Guidelines in Oncology. Investigators at the investigational sites will~     enter patient data into an electronic data capture (EDC) system up to the third chemotherapy~     in the study. The end of the study is defined as the time the last patient completes~     observational period. Patients will primarily be assessed by overall survival (OS) of the~     first line chemotherapy.~   "
77601|NCT02551250|"~     The investigators will investigate the usefulness of biannual ultrasonography versus annual~     non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma in~     single arm patients.~   "
77602|NCT02551237|"~     The purpose of the study is to compare pre-operative radio-chemotherapy (RT + capecitabine)~     to a short course RT associated with a delayed surgery, with two primary objectives: the~     efficacy evaluation (rate of R0 resection) and the preservation of autonomy (score IADL).~   "
77603|NCT02551224|"~     The purpose of this study is to compare in COPD patients naïve to DPIs, the perception of the~     Breezhaler® and Ellipta® devices' feedback mechanisms evaluated using a preference~     questionnaire.~   "
77604|NCT02551211|"~     With the recent approval of Nivolumab for second-line treatment of stage IIIb/IV non-small~     cell lung cancer (NSCLC), immune checkpoint inhibitors are entering the standard of care for~     lung cancer. Other immune checkpoint inhibitors are under evaluation, both in resectable and~     non-resectable NSCLC. In order to refine our use of these molecules, comprehensive data on~     the immune contexture of NSCLC are needed. Moreover,a blood marker of this contexture would~     allow physicians to monitor the immune status of their patient's tumor and though to evaluate~     the rightful place of immunotherapy in the multimodal treatment of NSCLC. No such blood~     marker has been validated so far. The LYMPHOLUNG study investigate the concordance between~     blood and intratumoral counts of immune cells in resectable stage I to IIIA NSCLC. By the use~     of 30-marker cytometry, a precise immune profile of NSCLC will be depicted. The prognostic~     value of the circulating and intra-tumoral T regulator over total lymphocytes ratio for~     2-year recurrence-free survival will also be addressed.~   "
77605|NCT02551198|"~     Colonoscopy is considered by many the preferred mode of screening for colorectal cancer~     (CRC). The effectiveness of any CRC screening program is critically dependent on an adequate~     bowel preparation.~      For bowel preparation, effective, well-tolerated and safe methods should be applied.~      Recently, oral sulfate solution was adopted to Korea. Still, in Korea, there was no data of~     direct comparison of 2L polyethylene glycol with ascorbic acid (PEG-Asc) and oral sulfate~     solution (OSS) in split method for bowel preparation. Therefore, in this study, we planned~     the comparative evaluation the efficacy of PEG-Asc and OSS in split method for bowel~     preparation~   "
77606|NCT02551185|"~     This is a Phase 1b, multicenter, single arm, open label, dose escalation study to determine~     the MTD and evaluate the safety and preliminary antitumor activity of orally (PO)~     administered ACY 241 in combination with intravenously (IV) administered paclitaxel in~     eligible patients with advanced solid tumors.~   "
77607|NCT02551172|"~     To investigate the efficacy and safety after administration of HCP1105 in hyperlipidemic~     patients with high risk for CHD.~   "
77608|NCT02551159|"~     This is a randomized, open-label, multi-center, 3-arm, global Phase III study to determine~     the efficacy and safety of MEDI4736 + tremelimumab combination or MEDI4736 monotherapy versus~     SoC (EXTREME regimen) in the treatment of patients with SCCHN who have not received prior~     systemic chemotherapy for recurrent or metastatic disease.~   "
77611|NCT02551120|"~     Hypoparathyroidism (hypoPT) and pseudohypoparathyroidism (Ps-hypoPT) are rare diseases,~     characterized by low levels of parathyroid hormone [PTH] and plasma calcium or high plasma~     PTH and low plasma calcium, respectively. A recently study by the investigators' group,~     identified 123 living persons with idiopathic hypoPT and 62 living persons with Ps-hypoPT,~     only few of these have been genetic tested.~      The aim of the study is to perform a detailed clinical and genetic characterization of Danish~     patients with idiopathic hypoPT and Ps-hypoPT. Patients will be examined by questionnaires,~     biochemistry, scans, bone biopsies and genetic tests. Furthermore the investigators aim to~     perform family tracing for the hereditary forms. The prevalence of magnesium depletion will~     be assessed as well.~      In addition to providing new information on symptoms, co-morbidity, and prognosis for this~     group of patients, the investigators presume that the study may improve their understanding~     on calcium homeostasis and bone metabolism in general.~   "
77612|NCT02551107|"~     This pilot study aims to measure nasal nitric oxide (nNO) in a group of neonates and infants~     (≤ 12 months) with congenital heart disease (CHD) and compare their nNO levels to age matched~     controls without CHD. CHD patients will be divided into subgroups, based on their cardiac~     anatomy, to try and identify a level of risk of ciliary dyskinesia within the subgroup of~     CHD. Each of these sub groups' nNO levels will be compared between groups and against age~     matched control infants without CHD.~   "
77613|NCT02551094|"~     The study evaluates whether long-term treatment with colchicine reduces rates of~     cardiovascular events in patients after myocardial infarction. Patients who have suffered a~     documented acute myocardial infarction within the last 30 days, are treated according to the~     national guidelines and after having completed any planned percutaneous revascularization~     procedures associated with their initial infarction will receive either colchicine (0.5 mg~     per day) or matching placebo (1:1 allocation ratio) for an estimated 2 years period or until~     the target of 301 primary endpoints has been reached.~   "
77614|NCT02551081|"~     The purpose of study is to evaluate the benefits of using the Next Generation Sequencing~     Technology to diagnose birth defects and genetic diseases. The results from genomic~     sequencing can also significantly shorten the time of examination, improve the diagnosis~     rate, guide the clinical treatments. So the ultimate goal is individualized or personalized~     therapy and promote prognosis.~   "
77615|NCT02551068|"~     The purpose is to determine if patients with idiopathic pulmonary fibrosis (IPF) taking~     nintedanib will have improved exercise endurance, breathlessness and quality of life if~     breathing 60% oxygen compared to standard of care during an 8 week exercise training program.~   "
77616|NCT02551055|"~     The purpose of this study is to evaluate the maximum tolerated dose (MTD) or recommended Part~     2 dose, safety and efficacy of MLN1117 (TAK-117) in combination with docetaxel, paclitaxel,~     investigational TAK-659 or investigational alisertib in adult participants with advanced and~     metastatic gastric or gastroesophageal adenocarcinoma. The study consists of a dose~     escalation phase (Part 1) and a dose expansion phase (Part 2).~   "
77617|NCT02551042|"~     Many patients with Scleroderma (Systemic sclerosis) experience damage to blood vessels,~     mainly to the small arteries. A common manifestation of this is Raynaud's phenomenon (fingers~     or toes turning white then blue in the cold) and digital ulcers (open sores on the~     fingertips). The purpose of this study is to see how effective the study drug Human Factor~     XIII Concentrate is in treating patients who have these and other common manifestation of~     Scleroderma. It will be given in addition to the accepted treatments used for this disease.~   "
77618|NCT02551029|"~     Brain imaging has shown abnormal brain activations in response to visceral stimulation in~     patients with the Irritable Bowel Syndrome (IBS). To investigate the possible role of the~     Nucleus of the Solitary Tract (NTS), the primary relay station in the brainstem for vagal~     afferents, its activation in IBS and functional dyspepsia patients will be evaluated. Prior~     to this, an exploratory study in healthy volunteers will be conducted. This will be the first~     high magnetic field fMRI study evaluating the possible role of NTS activation in visceral~     abdominal pain. Moreover, this will be the first fMRI study using duodenal capsaicin infusion~     as a chemical stimulus, which is more physiological than mechano-stimulation.~   "
77619|NCT02551016|"~     The main objectives of this study are i) to assess how heart failure was captured accross~     different linked electronic health record sources within the CALIBER program and the overlap~     between primary care, hospital admissions and/or the national mortality register, and ii) to~     assess risk factors, heart failure treatment and survival in patients, stratified by EHR~     source.~   "
77620|NCT02551003|"~     This study examines the effect of cord blood in the treatment of newborn infants with~     neonatal encephalopathy in combination with hypothermia, which is the standard treatment for~     this condition. The hypothesis is that the cord blood + hypothermia combination will produce~     better neuroprotection than the standard treatment of hypothermia alone.~   "
77621|NCT02550990|"~     The purpose of this study is to determine the treatment effects of sequential combination of~     aerobic exercise and cognitive training on cognitive function, physiological markers, daily~     function, physical function, social participation and quality of life in stroke patients with~     cognitive decline. The investigators hypothesized that: (1) sequential training protocol can~     improve outcome measures compared to single mode of training; (2) these treatment effects~     will retain at 6-month follow-up.~   "
77622|NCT02550977|"~     The purpose of this study is to look into the effectiveness of a new investigational~     medication applied as a transdermal patch. The patch is applied on the skin with study~     medication that is absorbed through the skin suppressing ovarian activity and therefore~     preventing an egg from leaving an ovary (ovulation). The study will look into the study~     drug`s safety and how well it is tolerated and its absorption, breakdown and elimination in~     the body. It describes how the body affects a specific drug after administration.~   "
77623|NCT02550964|"~     The purpose of this study is to evaluate the incidence and risk factor of toxic maculopathy~     who treated with hydroxychloroquine or chloroquine due to their autoimmune disease such as~     rheumatoid arthritis or systemic lupus erythematosus. Total 5-year of the study periods, the~     investigators will screen these patients by baseline examination (Fundus photography, fundus~     autofluorescence, spectral-domain optical coherence tomography, Humphrey visual field test~     and multifocal electroretinography) and observe with same examination for every year.~   "
77629|NCT02550886|"~     In 2011, 38.6 million hospital stays occurred in the United States at a cost of $387.2~     billion. 47.9 percent involved hospitalizations during which surgical procedures were~     performed. Orthopedic procedures constituted the most frequently performed and most costly of~     operating room procedures. As the healthcare climate in the United States continues to~     change, there is a trend towards providing effective care in a fiscally conservative manner.~     Central to this strategy is the shift towards increasing ambulatory surgical procedures from~     surgeries requiring post-operative admission for patients. While savings to hospitals and~     third-party payers are implied, there may be an unrecognized increase in financial, physical,~     and psychosocial post-operative costs to patients undergoing ambulatory surgery and to their~     caregivers. Rawal et al., and McGarth and colleagues have found that patients undergoing~     orthopedic procedures had moderate to severe post-operative pain. We propose to present a~     survey to patients and their caregivers before surgery and at multiple timepoints~     post-operatively to acquire information on the impacts of ambulatory orthopedic surgery. In~     addition to assessing post-operative pain, this study serves to examine various other~     possible burdens to patients that have not been previously evaluated in this patient~     population.~      REFERENCES~      McGarth B, Elgendy H, Chung F, Kamming D, Curti B, King S. Thirty percent of patients have a~     moderate to severe pain 24 hr after ambulatory surgery: a survey of 5,703 patients. Can J~     Anesth. 2004; 51:886-891.~      Rawal N, Hylander J, Nydahl P, Olofsson I, Gupta A. Survey of postoperative analgesia~     following ambulatory surgery. Acta Anesthesiol Scand. 1997; 41:1017-1022.~   "
77630|NCT02550873|"~     This study is a Phase 2, randomized, double-blind, placebo controlled, pilot study designed~     to evaluate the efficacy and safety of PRM-151 administered through Week 24 to subjects with~     IPF.~   "
77631|NCT02550860|"~     The epidermal barrier efficacy is determined by the physicochemical properties of the~     epidermal lipid matrix, among which ω-6 essential fatty acids (EFAs) play a key role.~     Inversely, the ω-3 EFAs are not found in the epidermis. For patients receiving~     lipid-containing parenteral nutrition (LCPN), the improvement of the epidermal barrier~     through the infusion of most appropriate intravenous fat emulsions (IVFE) could have many~     applications in clinical nutrition, mainly limiting water loss in patients receiving~     long-term LCPN and help in electrolyte and water balance.~      The objective of this interventional clinical trial is to evaluate the epidermal barrier~     function in patients receiving long-term LCPN comparing two compositions of IVFE: (i) soybean~     oil (SO)-based IVFE (Medialipide) or (ii) fish oil (FO)-containing IVFE (Lipidem). Epidermal~     barrier function will be assessed through the transepidermal water loss (TEWL) measurement on~     the skin surface, a validated marker of the epidermal barrier efficacy. The two IVFE~     (SO-based or FO-containing) will be compared using a randomized double blind crossover~     design, using patients as their own control. Each IVFE will be allocated for a 3-month~     period, allowing sufficient timeframe for epidermal complete renewal. Patient's epidermal and~     red blood cell EFA profile will be determinate in order to facilitate result interpretation.~   "
77632|NCT02550847|"~     The aim of this study was to evaluate MR/PET with both functional and molecular imaging on~     the prediction of prognosis in patients with suspected pancreatic cancer.~   "
77633|NCT02550834|"~     This study investigates if, patients with diagnosed chronic spinal cord injury will benefit~     from an Indoor Curling Exercise program on their control capabilities of trunk movements and~     on their intrinsic motivation for physical activity. Half of participants will receive 8~     training-sessions during 4 weeks, while the other will receive usual care.~   "
77634|NCT02550821|"~     The purpose of this study is to compare physical activity levels between patients with~     bronchiectasis and healthy subjects.~      We hypothesize that patients with bronchiectasis will have lower levels of physical activity,~     since physical activity levels is affected by reduced exercise tolerance, severity of disease~     and other disease related symptoms and conditions.~   "
77635|NCT02550808|"~     This study aims to evaluate prevalence of sarcopenia and cachexia in patients with chronic~     cardiopulmonary disease. The investigators will also investigate metabolic disorders like~     glucose metabolism, presence of metabolic syndrome, body composition and histological changes~     in skeletal muscle and body fat. Finally, patients will be followed for clinical endpoints.~   "
77636|NCT02550795|"~     Previous reports demonstrated that dexmedetomidine could reduce the incidence of~     postoperative nausea and vomiting (PONV). Dexamethason also had been commonly used for~     ajuvant drugs for preventing and reducing PONV. So investigator want to study about the~     effect of dexmedetomidine only or combined with dexamethasone for preventing PONV.~   "
77637|NCT02550782|"~     Infraclavicular block is one of the peripheral nerve block used in upper extremity surgery.~     Adjuvant agents are used in peripheral nerve blocks to increase the duration and block~     quality. We investigated that the effects of patient-controlled perineural dexmedetomidine~     application on postoperative analgesia.~   "
77638|NCT02550769|"~     INTRODUCTION: Transanal TME (T-TME) combined with laparoscopy, called hybrid-NOTES, is a less~     invasive procedure that responds to some of the limitations of the rectal laparoscopic~     approach.~      MAIN OBJECTIVE: To analyze that the T-TME gets a faster recovery due to a lower conversion~     rate to open surgery than laparoscopic low anterior resection (L-LAR) in rectal cancer with~     the same pathological, functional and oncologic results.~      METHODOLOGY: A prospective multicenter randomized controlled study of patients with rectal~     cancer that, were randomized in the T-TME- and L-LAR group. The main variables are: general~     morbidity, anastomotic dehiscence, conversion rate to open surgery and hospital stay. The~     sample calculation is 58 patients per group.~   "
77639|NCT02550756|"~     The purpose of this study is to confirm that the local anesthetic applied to subjects with~     Morton's Neuroma satisfactorily mitigates procedure pain and ensures that post-procedure~     discomfort or pain will not result in bias or breaking of the blind in the planned Phase 2b~     study.~   "
77640|NCT02550743|"~     The primary goal of this Brown University Oncology Research Group is to determine that a safe~     dose of BYL719 can be administered with capecitabine and radiation in patients with rectal~     cancer. Therefore, the threshold of success for this phase I study is to establish safety.~   "
77706|NCT02549885|"~     The purpose of this study is to determine whether the contract-relax technique of~     proprioceptive neuromuscular facilitation, and the static stretching exercise are effective~     in reducing the frequency, intensity and duration of headache and in improving the perception~     of quality of life in women with migraine.~   "
77641|NCT02550730|"~     Peer support during labor, birth and the perinatal period (also known as doula support) has~     been shown in some studies to reduce cesarean rates, postpartum depression and increase~     breastfeeding rates. The purpose of this program evaluation is to prospectively assess the~     clinical and cost outcomes of Boston Medical Center's Birth Sister doula program, one of the~     few established, hospital-based programs in the United States. To enhance the capability of~     the Birth Sisters Program to impact social determinants of perinatal health in a low-income~     population, the program evaluation will include the addition of Medical Legal Partnership for~     Children's (MLP) training and referral services. This program will be described as the Birth~     Sisters Best Beginnings services (BBB). The evaluation will compare the effects of BBB~     compared with no Birth Sister support for women receiving maternity care at Boston Medical~     Center. Eligible women will be randomly assigned either BBB services or usual care. All women~     will be consented and interviewed in the mid-second trimester of pregnancy and interviewed~     again at 6-8 weeks postpartum. Women randomized to the BBB will be offered 8 prenatal Birth~     Sister visits in the home or at Boston Medical Center starting at 6 months of pregnancy,~     continuous support through labor and birth, and up to 4 postpartum Birth Sister visits in the~     home or at Boston Medical Center. The usual care group will receive no birth sister support~     but does have access to standard interdisciplinary maternity care services. The primary~     outcomes will be reduction in cesarean rate. Secondary outcomes will include cost, labor~     interventions, infant outcomes, satisfaction with care and psychosocial outcomes, including~     depression, social functioning and self-efficacy.~   "
77642|NCT02550717|"~     To investigate the risk of major bleeding (including gastrointestinal and intracranial~     bleeding episodes) among new users of low-dose acetylsalicylic acid (ASA) in clinical~     practice~   "
77643|NCT02550704|"~     Visceral hypersensitivity, low grade inflammation and increased intestinal permeability are~     three main pathophysiological mechanisms involved in irritable bowel syndrome. The connexion~     between these abnormalities is not known. We hypothesis there is a link between them in IBS~     with diarrhoea.~   "
77644|NCT02550691|"~     Spinal Muscular Atrophy (SMA) is a neuromuscular disorder characterized by loss of motor~     neurons in the anterior horn of the spinal cord and leading to muscle atrophy. SMA has an~     autosomal recessive inheritance and affects 1 in 6000 infants with a carrier frequency of 1~     in 40. In most cases, it is caused by homozygous gene deletion or gene conversion of the SMN1~     gene (0+0 genotype) on 5q11-q13. This genomic region has been duplicated and inverted during~     evolution. Thus the SMN1 gene has a very homologous copy, called SMN2. Genetic counseling aim~     at detecting carriers with only one copy of the SMN1 gene (0+1 genotype). SMA carrier testing~     relies on total copy number quantification of the SMN1 copies by quantitative PCR methods.~     Nevertheless, cis-duplication of the SMN1 gene on one allele and deletion on the second~     allele (2+0 genotype) can lead to a misinterpretation as molecular methods show 2 copies of~     the SMN1 gene and cannot detect the carrier status.~      The aim of the study is the characterization of a biomarker specific of the cis-duplication~     of the SMN1 gene in order to allow the detection of this 2+0 genotype which constitutes a~     trap for genetic counseling. We will use molecular combing to identify a genomic morse code~     (GMC) composed of a combination of probes specific of a structural motif on the~     cis-duplication chromosome. The characterization of this GMC is based on the comparison of~     two sample groups:~        -  The test group, with a maximum of 137 individuals carrying 3 copies of the SMN1 gene~          (suggesting a cis-duplication on one allele)~        -  The control-1 group, with a maximum of 137 individuals carrying 2 copies of the SMN1~          gene~      A pilot study performed on 24 samples in the two groups is needed to define the exact sample~     number necessary for statistical analysis of the study. When the GMC will be characterized,~     its specificity will be evaluated by testing two sample groups:~        -  The test group, with 37 individuals carrying 3 copies of the SMN1 gene~        -  The control-2 group, with 37 individuals carrying 3 copies of the SMN2 gene Molecular~          combing needs long DNA fibers and usual methods for DNA extraction are not appropriate.~          This project requires new blood samples for specific DNA extraction.~      If this project is successful, during a second project, this GMC will be converted into a~     simple and cheap PCR-based method. We will then evaluate the sensitivity of this method on~     our sample collection, notably on individuals with the 2+0 genotype defined by familial~     genotyping.~   "
77645|NCT02550678|"~     The study evaluates whether ASN-002 is safe and effective in the treatment of nodular basal~     cell carcinoma (nBCC) in patients aged 18 years or over.~      The participants will receive weekly injections of ASN-002 alone or in combination with 5-FU~     for 3 weeks and undergo surgical excision of the tumor.~   "
77646|NCT02550665|"~     This study evaluates the side effects of dose escalation in the treatment of donepezil 23mg~     for patients with Alzheimer's disease. Investigators randomly divide participants into three~     groups according to the dose escalation method; no titration, 15mg of donepezil for a month~     before escalation to 23mg, and alternating of 10mg and 23mg for a month before escalation to~     23mg.~   "
77647|NCT02550652|"~     This Phase II study will compare the efficacy and safety of obinutuzumab plus mycophenolate~     mofetil (MMF)/mycophenolic acid (MPA) with placebo plus MMF/MPA in participants with~     proliferative LN.~   "
77648|NCT02550639|"~     The aim of this prospective, randomized study is to assess a subject's immunological status~     against hCMV before kidney transplantation by an hCMV-specific interferon (INF)-γ ELISPOT~     technique confirming previous results and establishing their statistical validity in order to~     determine whether this test could be used routinely in clinical practice to assess the risk~     of developing hCMV infection after renal transplantation and, ultimately, identify the most~     effective individual antiviral therapeutic strategy against hCMV.~   "
77649|NCT02550626|"~     Hypothesis is that the presence of a-synucleinopathy related non motor symptoms could be~     predictive factor for post-operative delirium. During 72hrs after spine surgery, investigator~     will observe occurrence of post-operative delirium, and analysis difference of~     a-synucleinopathy related non motor symptoms between 2 groups.~   "
77650|NCT02550613|"~     The purpose of this study is to explore the ability of integrated MRI/PET to detect and~     evaluate treatment outcome in HCC patients.~   "
77651|NCT02550600|"~     The purpose of this study is to compare the effect of interventional Lung Assist iLA activve~     to standard therapy in mechanically ventilated patients with severe acute lung impairment.~     Hypothesis: iLA(active) reduces the incidence of an increase in SOFA-Score of ≥3 points (or~     death) within 28 days compared to standard treatment.~   "
77652|NCT02550587|"~     The level of patient satisfaction is an important indicator of health care quality because it~     causes to reconsider the functioning of the hospital and go to the new regulations.~     Postoperative thought gives us important information for improving the quality of anesthesia~     care and health care quality. The investigators aimed to investigate the status of the~     anesthesia satisfaction in patients.~   "
77653|NCT02550574|"~     The purpose of this study is to determine whether the use of 2-octylcyanoacrylate during~     repair of cutaneous surgery wounds with full-thickness skin grafts improves scar cosmesis~     compared to wound closure with sutures.~   "
77717|NCT02549742|"~     A phase II clinical trial testing electrochemotherapy on mucosal recurrent head and neck~     cancer. Twenty-five patients will be treated. Primary outcome is tumour response on imaging.~     Secondary outcomes are response from tissue samples, VAS score, Quality of life evaluation~     and side effects to treatment.~   "
77654|NCT02550561|"~     In 2014, the American Urological Association updated it management algorithm for Interstitial~     Cystitis/Painful Bladder Syndrome (IC/PBS). As the algorithm progresses, interventions become~     increasingly invasive and morbid. 4th line treatment is sacral neuromodulation (SNM),~     involving a two stage surgical procedure and permanent device implantation. While the~     mechanism for decrease in IC/PBS symptoms is unknown, SNM is thought act through central and~     peripheral mechanisms related to afferent signaling, causing modification of pain and lower~     urinary tract sensation.¹~      Percutaneous posterior tibial nerve stimulation (PTNS) is a method of peripheral~     neuromodulation targeting the same nerve roots as SNM, but with significantly fewer risks.~     The purpose of our research is to determine if PTNS is effective in the treatment of IC/PBS.~     The results of this study will suggest future directions and provide critical information to~     design studies to determine to what extent and in what situations PTNS may be effective.~      The investigators will enroll subjects with IC/PBS and urinary frequency/urgency to treatment~     with 12 weekly treatments of PTNS. The investigators will assess symptoms and lower urinary~     tract function before, during and after the treatments. At the completion of treatments,~     subjects will be asked to enroll in post-study follow up monitoring to understand the~     duration of symptom effect.~   "
77655|NCT02550548|"~     This project is designed to advance understanding of the incretin effect in health and~     disease. This system of gut-islet linkage is essential for normal glucose tolerance, impaired~     in T2DM, and amenable to therapeutic intervention. However, there are important gaps in~     understanding incretin function that limit application of this system; this project will~     address several of these. A secondary, but critical aspect of this research is focus on~     inter-individual variation in the physiology of the incretin system. This is a novel~     direction for research in this field and is critical to advancing the concept of~     individualized medical care in diabetes by establishing whether there is a physiologic basis~     for predicting the existence of responders and non-responders to incretin therapies.~      Currently, we have described only Aim 1 from this grant in this protocol registration. While~     Aim 2 and 3 are described in the grant, Aim 1 will be conducted first and the results from~     this Aim and / or the publication of other results in the field may affect the approach to~     Aims 2 and 3.~   "
77656|NCT02550535|"~     This is a Phase I/II trial to determine safety, clinical efficacy and feasibility of a~     gene-modified WT1 TCR therapy in patients with myelodysplastic syndrome (MDS) and acute~     myeloid leukaemia (AML).~      Patient's white blood cells (T cells) will be modified by transferring a gene which enables~     them to make a new T cell receptor (TCR) that can recognize fragments of a protein called WT1~     (Wilms' tumour 1) which is present at abnormally high levels on the surface of~     myelodysplastic and leukaemic cells.~      In this trial, approximately 25 participants with an Human Leukocyte Antigen A2 (HLA-A*0201)~     tissue type who have failed to achieve or maintain an IWG defined response following~     hypomethylating agent therapy will be recruited.~   "
77657|NCT02550522|"~     The BCI project falls within the very broad field of brain machine interfaces. Its multiple~     applications include the compensation of motor deficits. The subject of the present protocol~     is the first test of the system in man on the compensation of motor deficits by an epidural~     brain implant enabling an electrocorticogram (EcoG) to be recorded.~   "
77658|NCT02550509|"~     Muscle alterations and modifications passive biomechanical properties that occur on a spastic~     muscle contribute to functional disorders involved in spasticity. Botulinum toxin (TB) A is~     the reference treatment of the focused spasticity, and muscle source structural and~     biomechanical changes, very little studied in humans, especially since it is not one~     possibility of easily and reliably paraclinical assessment injections consequences.~   "
77659|NCT02550496|"~     Waiting for a proof by mycological culture is usually necessary before starting a systemic~     antifungal therapy. It therefore seems to us interesting to evaluate the benefit of using~     dermoscopy in clinical diagnosis of Tinea Capitis.~   "
77660|NCT02550483|"~     The study (n = 36) will be a parallel design and will be 6 weeks in duration. Participants~     will start with a 2-week free-living wash-in period where they will be asked to avoid certain~     carotenoid-rich foods, followed by 4 weeks of a completely controlled diet. In addition to~     the controlled diet, participants will consume one of three beverages (300 mL/day; n =~     12/group): placebo beverage (control), high beta-carotene tomato juice, and high-lycopene~     tomato juice. Blood, urine and feces will be collected throughout the study.~   "
77661|NCT02550470|"~     This is a prospective, randomized, double blind study investigating the duration of use and~     cost of the new CO2 absorbent Micropore's Spiralith®, compared to Drägersorb® 800+,~     Drägersorb® Free.~   "
77662|NCT02550457|"~     This study propose analyze the effects of Kinesio Taping® in chronic nonspecific low back~     pain. All the subjects will be submitted to an evaluation of the painful sensation,~     functional performance, trunk range of motion and neuromuscular performance at three~     different times.~   "
77663|NCT02550444|"~     The purpose of this study is to evaluate effects of intravenous clonidine in acute and~     chronic post-cesarean pain, possible adverse effects over mother-newborn pair, in comparison~     to intrathecal adjuvant clonidine and placebo.~   "
77664|NCT02550431|"~     This study plans to learn more about puberty blockers and cross (testosterone and estradiol).~     There is not much known about how these medications affect hormone levels, heart health and~     overall general health in young transgender individuals.~   "
77665|NCT02550418|"~     The purpose of the trial is to evaluate the efficacy of an 8 week treatment with once-daily 9~     mg budesonide in patients with active ulcerative colitis~   "
77666|NCT02550405|"~     This project aims to (1) investigate behavioral and neural factors (e.g., emotional factors~     such as craving and cognitive factors such as decision-making)) associated with Internet~     addiction (mainly Internet gaming disorder ;IGD); (2) develop an tailored intervention (named~     craving behavioral intervention; CBI) for IGD based previous evidence; (3) evaluate the~     behavioral and neural effects of CBI on individuals with IGD. This project in implemented in~     Beijing, China, based on a relatively large sample of young adults with IGD. It will advance~     the investigators' understanding of the characters associated with IGD and the mechanisms~     underlying the psychological-based interventions in the field of IGD, as well as other~     addictive disorder. Moreover, this study will also shed new light on the development of more~     effective interventions.~   "
77667|NCT02550392|"~     Transient Ischaemic Attack (TIA), also called 'ministroke' is characterised by shortlasting~     symptoms that generally do not cause permanent damage. 'Minor stroke' is a term used to~     describe a stroke with mild and nondisabling symptoms. TIA and minor stroke patients account~     for more than half of all cases of stroke and they are at a higher risk to suffer a major~     stroke. Currently, management of TIA/minor stroke patients is mainly focused on identifying~     and reducing risk factors for a later stroke. However, people after a TIA often have limited~     access for further specialist support from stroke-specific rehabilitation services. Although~     there is variability in the level of recovery and severity of symptoms after TIA and minor~     stroke, there is evidence that these patients may experience difficulties that affect their~     quality of life including anxiety and depression.~      This study aims to develop, tailor and target the delivery of a time-limited group~     intervention that offers educational, psychological and social support for people following~     TIA and minor stroke. A qualitative study (Phase 1) will be conducted with service users and~     experts working with people with TIA/minor stroke to develop the psychoeducational~     intervention. Following this, we will conduct a feasibility randomised controlled trial in~     one centre (Phase 2) to explore whether this group psychoeducational intervention for people~     after TIA and minor stroke carers is acceptable and to determine the feasibility of the~     proposed evaluation and the sample size needed in a definite trial.~   "
77668|NCT02550379|"~     While it has been hypothesised that individuals who experience social anxiety are more likely~     to misread facial emotions as threatening or disapproving, researchers have proposed that the~     difficulty may lie in decoding ambiguous facial expressions rather than identifying emotions~     which are expressed with greater intensity. Emotion recognition (ER) training provides a~     promising new avenue of research which may be beneficial in altering emotion processing~     biases which maintain or increase symptoms of mental health disorders. This study will~     examine the effectiveness of ER training in a community-based sample of young people (15-18~     years) who report high levels of social anxiety. The intervention aims to alter emotion~     processing biases through a training procedure designed to promote the perception of~     happiness over disgust in ambiguous facial expressions which we hypothesise will subsequently~     reduce symptoms of social anxiety.~      The study design consists of two phases. During Phase 1 participants will complete a~     screening questionnaire. This questionnaire will include a measure of the affective,~     cognitive, and behavioural components of social anxiety in adolescence. Depending on their~     suitability (i.e. scoring above a cut-off on a standardised measure of social anxiety in~     Phase 1 of the study), participants may then be invited to take part in a 4-day~     computer-based emotion recognition training programme (Phase 2). The purpose of this phase is~     to see if ER training will help young people feel less worried or nervous in social~     situations by training them to interpret ambiguous facial expressions as expressing a~     positive emotion (happy rather than disgusted).~      Participants will be randomly assigned to either the intervention or placebo (inactive)~     group. Both groups will be asked to complete a 4-day programme involving one computer~     training session per day (each session takes approximately 20 minutes). Questionnaires will~     also be given to participants to complete before and after the intervention, along with a~     2-week follow-up assessment. These will include questionnaires to measure social anxiety,~     depressive symptoms, and fear of negative evaluation. Each questionnaire will take~     approximately 15 minutes to complete. Participants will not know whether they have received~     the intervention or placebo training until after the intervention.~   "
77669|NCT02550366|"~     Coronary artery disease (CAD) is the leading cause of death in the United States. Cardiac MRI~     is a non-invasive non-ionizing technique for a comprehensive cardiac exam, which can be used~     in the diagnosis of CAD. In this work, the investigators will develop and validate techniques~     for accelerated cardiac MRI, offering better volumetric coverage of the heart, improved~     contrast, and superior spatial and temporal resolutions.~   "
77670|NCT02550353|"~     The aim is to evaluate the short-term changes in ocular surface measures and tear~     inflammatory mediators after lenticule extraction (FLEx) and femtosecond laser-assisted laser~     in situ keratomileusis (FS-LASIK) procedures.~   "
77671|NCT02550340|"~     The study aims to determine if acute recreational alcohol intake is associated with the~     occurence of ECG changes and arrhythmias.~   "
77672|NCT02550327|"~     The objective of this study is to improve survival by the addition of anakinra to the~     chemotherapy combination of nab-paclitaxel, gemcitabine, and cisplatin in patients with~     resectable or potentially resectable pancreatic adenocarcinoma (PDAC). The primary endpoint~     of the study is to determine whether the combination of abraxane, gemcitabine, cisplatin, and~     anakinra will improve disease-free survival (DFS) and to determine the number of patients who~     meet or surpass 11.5 months of DFS.~      The secondary objectives of this study are to evaluate the effect of anakinra when combined~     with the three-drug regimen of nab-paclitaxel, gemcitabine, and cisplatin on response rate~     and overall survival after diagnosis and adverse events of patients with resectable or~     potentially resectable PDAC. The investigators will use the benchmark of 24 months overall~     survival (OS) to determine how many patients meet or exceed this goal. The investigators will~     monitor, by survey, patients' health related quality of life while on treatment to determine~     if the addition of anakinra improves this measure.~   "
77673|NCT02550314|"~     To assess the efficacy and safety of the regeneration treatment of tympanic membrane with~     NPC-18 and FBG-18.~   "
77674|NCT02550301|"~     Platelets play a major role in thrombus formation and platelet size, measured by Mean~     Platelet Volume (MPV) correlates with platelet activity. MPV is increased in patients with~     Myocardial Infarction (MI) and is an independent predictor of adverse events in patients with~     ST Elevation Myocardial Infarction (STEMI) . Data on MPV in patients with stable angina is~     limited.~      Aspirin and clopidogrel are antiplatelet agents administered routinely to patients undergoing~     PCI and are required for stent patency. MPV is not known to be affected by low dose Aspirin.~     Treatment with clopidogrel is thought to reduce MPV in-vitro but the magnitude of this~     reduction in MPV is unclear, especially in patients with stable angina undergoing PCI. An~     inverse correlation also exists between MPV and platelet count .~      The investigators aim to assess if a change occurs in MPV (∆ MPV) after routine clopidogrel~     administration in patients with stable angina undergoing PCI.~   "
77675|NCT02550288|"~     This study will evaluate the efficacy and safety of MK-0653C (Ezetimibe [EZ] 10~     mg/Atorvastatin [Atora] 10mg or 20 mg) compared to EZ 10 mg, Atora 10 mg, or Atora 20 mg~     alone when administered to Japanese participants with hypercholesterolemia. The primary~     hypothesis is that MK-0653C (EZ 10 mg/Atorva 10 mg) is superior to EZ 10 mg and is superior~     to Atorva 10 mg and that MK-0653C (EZ 10 mg/Atorva 20 mg) is superior to EZ 10 mg and is~     superior to Atorva 20 mg in percent change from baseline in low-density lipoprotein~     cholesterol (LDL-C) after 12 weeks of treatment.~   "
77688|NCT02550119|"~     This randomized pilot clinical trial dolasetron mesylate and dexamethasone with or without~     aprepitant in preventing nausea and vomiting in patients undergoing oxaliplatin-containing~     chemotherapy for gastrointestinal malignancy. Antiemetic drugs may help lessen or prevent~     nausea and vomiting in patients treated with chemotherapy. It is not yet known whether giving~     aprepitant together with dolasetron mesylate and dexamethasone is more effective than~     dolasetron mesylate and dexamethasone alone in preventing nausea and vomiting.~   "
77676|NCT02550275|"~     Huntington's disease is a rare genetic neurodegenerative disease. It is accompanied by~     movement disorders, cognitive and behavioral. The social behavior of patients are changed,~     affecting interpersonal relationships. Patients with Huntington's disease are described as~     self-centered, lacking sympathy and empathy and mentally inflexible. These behavioral~     problems can be a major source of anxiety for patients and their families. These disorders~     also have a negative impact cognitive and motor symptoms as well as the functional abilities~     and the quality of life of patients and their entourage. Authors have suggested that these~     problems could be related inter alia to social cognition disorders. This concept refers to a~     set of skills and emotional and social experiences that regulate relations between~     individuals and can explain the behavior of individuals and groups. The objective is to~     evaluate disorders of social cognition, which may account for behavioral changes in~     Huntington's disease.~   "
77677|NCT02550262|"~     Until recently, at Mount Sinai Hospital, epidural analgesia for labor pain was delivered with~     a pump that could only provide continuous infusion of the freezing medication in combination~     of pushes of medication activated by the patient, a technique called patient controlled~     epidural analgesia (PCEA). In the last decade or so, the literature has suggested that this~     continuous infusion of medication is not as effective as previously thought, and suggested~     that instead of continuous infusion, intermittent programmed pushes should be used. The~     investigators now have devices that are able to do that. Programmed intermittent epidural~     bolus (PIEB) is a new technological advance based on the concept that boluses of freezing~     medication in the epidural space are superior to continuous epidural infusion (CEI). The new~     pumps are able to deliver bolus of medication at regular intervals (PIEB), in addition to~     what the patient can deliver herself (PCEA). Studies have shown that delivering analgesia in~     this manner can prolong the duration of analgesia, diminish motor block, lower the incidence~     of breakthrough pain, improve maternal satisfaction and decrease local anesthetic~     consumption. Based on the information already available in the literature, this study aims to~     determine the best regimen of PIEB achievable with our standard epidural mixture.~      The hypothesis of this study is that there is an optimal interval time between PIEB boluses~     of 30 to 60 minutes at a fixed volume of 10 ml of our standard epidural mixture that will~     provide women the necessary drug requirements, thus avoiding breakthrough pain and need for~     PCEA or physician intervention.~   "
77678|NCT02550249|"~     Neoadjuvant nivolumab will be administered to patients with primary and recurrent~     glioblastoma multiforme that require surgery. Nivolumab will be continued following surgery.~   "
77679|NCT02550236|"~     The Leipzig Research Centre for Civilization Diseases (LIFE) Child Study is a prospective~     longitudinal population-based study with a life course approach to health and disease.~      The LIFE Child Study focuses on two main research objectives:~        -  monitoring of normal growth, development and health~        -  non-communicable diseases such as childhood obesity and its co-morbidities, atopy and~          mental health problems~      Detailed assessments will be conducted alongside long-term storage of biological samples in~     2,000 pregnant women and more than 10,000 children and their families.~   "
77680|NCT02550223|"~     Comparing an novel technique ( oblique view) during ultrasound guided radial artery~     catheterization versus Transverse and longitudinal views~   "
77681|NCT02550210|"~     In this study, the investigators will enroll women with palpable cancers to assess the~     accuracy of the Breast Cancer Locator (BCL) and concomitant procedure as a vehicle to~     optimize and validate the approach in surgical cases where the new device will not~     substantially alter or modify the standard-of-care procedure before initiating an evaluative~     trial of the BCL in non palpable breast cancer cases.~   "
77682|NCT02550197|"~     The aim of the trial is to evaluate immunogenicity and safety of the quadrivalent influenza~     vaccine (QIV) and the trivalent influenza vaccine (TIV) (split-virion inactivated) Northern~     Hemisphere (NH) 2015 2016 seasonal formulations, in subjects aged 18 to 60 years in the~     Republic of Korea for the registration of the QIV by the Ministry of Food and Drug Safety.~      Objectives:~        -  To evaluate the immunogenicity of QIV and TIV (split-virion, inactivated) NH 2015-2016~          seasonal formulations. The compliance, in terms of immunogenicity, of the QIV NH~          2015-2016 formulation, with the requirements of the Committee for Medicinal Products for~          Human Use (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96 will be assessed.~        -  To evaluate the safety profile of QIV and TIV (split-virion, inactivated) NH 2015-2016~          seasonal formulations~   "
77683|NCT02550184|"~     Aim To investigate if the proportion of correctly diagnosed patients at 4 hours after arrival~     to the Emergency Department (ED) increases when patients are diagnosed with standard~     diagnostics and focused ultrasonography examination (f-US) compared to standard diagnostics~     alone.~      Methods The investigators are medical doctors who work in the ED and who use f-US as a~     diagnostic tool. The patients are those arriving to the ED with symptoms of difficulties of~     respiration.~      All patients receive a f-US but only in the intervention group these results will be~     unblinded to the treating physician once he has made his 1. presumptive diagnosis . A final~     presumptive diagnosis has to be made within 4 hours from the patient´s admittance to the ED.~      The correct diagnosis is assessed by a blinded audit of the medical journal. This project~     holds the potential to develop evidence-based optimization of early diagnostic accuracy.~   "
77684|NCT02550171|"~     The BioGene bank: Is a centralized collection of human blood samples along with de-identified~     (coded) health information, environmental factors, family disease histories and information~     from DNA. Limited to the NSLIJHS catchment area.~   "
77685|NCT02550158|"~     This study has the objective to demonstrate that an education program could have a~     significant impact on Inflammatory Bowel Disease (IBD) patient's skills with regards to their~     disease.~   "
77686|NCT02550145|"~     The purpose of this study is to evaluate the role of GLP-1 in causing extreme postprandial~     glucose reductions after bariatric surgery in a subset of patients who have severe~     symptomatic hypoglycemia.~   "
77687|NCT02550132|"~     The objective of the present study is to determine if spinal manipulations with a constant~     rate of force application but with different peak force and time to peak force lead to~     similar responses in healthy adults.~   "
77689|NCT02550106|"~     Evaluate the proportion of patients with an urticaria control test [UCT] score of greater~     than or equal to 12 at Week 12.~   "
77690|NCT02550093|"~     Oxytocin is neurohypophysial peptide that acts mainly as a neuromodulator in the brain.The~     vast majority of basic science studies suggested a large effect of oxytocin in minimizing~     acute pain.Few studies have demonstrated an association between plasma levels of oxytocin and~     pain in humans. Since addictive properties of oxytocin have not been described, the drug may~     have important application in the management of acute and chronic pain. No studies have~     examined the effect of intranasal oxytocin on pain sensitivity and threshold.~   "
77691|NCT02550080|"~     This Study is to evaluate the utility of prospective HLA-B*1301 screening on the incidence of~     dapsone hypersensitivity syndrome (DHS) in 3130 previously Dapsone(DDS)-naive patients. Those~     patients include allergic cutaneous vasculitis, urticaria, psoriasis, acne, bullous skin~     diseases, sterile pustulosis, leprosy, pneumocystis pneumonia and any other patients who need~     dapsone administration. The study has two (co-primary) objectives: i) to determine if~     screening for HLA-B*1301 prior to DDS-containing treatment results in a lower incidence of~     clinically-suspected DHS versus current standard of care (no genetic screening) and ii) to~     determine if screening for HLA-B*1301 prior to DDS-containing treatment results in a~     significantly lower incidence of immunologically-confirmed DHS versus current standard of~     care (no genetic screening or patch testing). The study consists of up to a 5-day screening~     period, a randomised observation period (Day 1 through Week 6) and, for subjects experiencing~     a suspected DHS and a subset of DDS-tolerant subjects, an epicutaneous patch test (EPT)~     assessment period. Eligible subjects will be randomised to one of two study arms: a Current~     Standard of Care Arm (no prospective genetic screening: Control) and a Genetic Screening Arm~     (prospective genetic screening: Case). Subjects identified as HLA-B*1301 positive in the~     prospective Genetic Screening Arm will not receive dapsone and will be excluded from further~     study. Subjects who experience suspected DHS during the 6-week observation would be withdrawn~     from dapsone and undergo EPT patch testing 6 weeks later.~   "
77692|NCT02550067|"~     The ECHO Study is an open-label randomized clinical trial that will compare three highly~     effective, reversible methods of contraception (including a non-hormonal method) to evaluate~     whether there is a link between use of any of these methods and increased risk of acquiring~     HIV infection. A randomized clinical trial among about 7,800 women in four countries, ECHO~     will deliver evidence to support and guide individual, policy and programmatic decisions on~     contraception for women at risk of acquiring HIV infection.~   "
77693|NCT02550054|"~     The main goal of this trial is to investigate whether early administration of human~     erythropoietin (EPO) in preterm infants improves neurodevelopmental outcome at 18 months~     corrected age. This study is designed as randomized, double-masked, placebo controlled~     multicenter study involving at least 312 patients.~   "
77694|NCT02550041|"~     The study aims to asses the ability of cell tests based on the analysis of the~     anti-Aspergillus cell responses and identify Aspergillus bronchitis with patients with cystic~     fibrosis.~      In addition, the study will evaluate the contribution of biological classification of~     aspergillosis according to criteria recently proposed by Baxter et al. compared to the~     classification used in clinical practice in the hospital of Montpellier.~   "
77695|NCT02550028|"~     Current treatments for the brain damaging complication of neonatal seizures are~     unsatisfactory. A multi-centre Chinese clinical trials with the aim to using oral~     Levetiracetam to develop new treatment strategies for the treatment of neonatal seizures. The~     purpose of this study is to determine the correct oral dosing, safety and efficacy for oral~     Levetiracetam as first line treatment in term new born babies with seizures.~   "
77696|NCT02550015|"~     The purpose of this study is to examine if high intensity interval training after stroke is~     more effective than standard care to increase maximal oxygen uptake, reduce known risk~     factors for recurrent stroke and improve function.~   "
77697|NCT02550002|"~     The primary objective of this study is to test non-inferiority of aflibercept treat and~     extend using a relaxed retinal fluid management relative to aflibercept treat and extend~     using a strict retinal fluid management SD-OCT (spectral domain optical coherence tomography)~     disease activity guided retreatment with respect to best-corrected visual acuity (BCVA) from~     baseline to end of treatment.~   "
77698|NCT02549989|"~     The purpose of this study is to determine the effectiveness of LY3023414 in treating the~     participants type of cancer and to determine the types and severity of side effects caused by~     treatment with LY3023414.~   "
77699|NCT02549976|"~     The primary objective is to evaluate digestive damage in CD 5 to 10 years after diagnosis in~     the GETAID centers included in the RAPID study. Secondary objective is to identify predictive~     factors of the evolution digestive damage.~   "
77700|NCT02549963|"~     This is a prospective, multi-center, randomized, pilot study comparing the WATCHMAN left~     atrial appendage occlusion device with Rivaroxaban therapy in patients with non-valvular~     atrial fibrillation.~   "
77701|NCT02549950|"~     The purpose of this study is to provide evidence on the effectiveness, the efficiency and~     efficacy of Peizo-Corticission in accelerating orthodontic tooth movement and reducing~     orthodontic treatment time.~   "
77702|NCT02549937|"~     Primary Objective:~      To evaluate the safety and tolerability of sulfatinib in patients with advanced solid tumors~     and to determine the maximum tolerable dose (MTD) or recommended phase II dose (RP2D).~      Secondary Objective： To evaluate the pharmacokinetic profile of multiple dose sulfatinib in~     patients with advanced solid tumors and to evaluate the anti cancer activity of sulfatinib in~     patients with advanced solid tumors.~   "
77703|NCT02549924|"~     Type 2 diabetes mellitus [ T2DM ] has quickly become the epidemic of the XXI century and~     challenging global health . Estimates of the World Health Organization [ WHO ] indicate that~     globally , from 1995 to date has nearly tripled the number of people living with diabetes~     mellitus [DM ]. Resveratrol has been extensively studied as a regulator of glucose through~     its antioxidant effects and protecting pancreatic β cells by activation of sirtuin -1 [ SIRT1~     ] dependent deacetylase nicotinamide adenine diphosphate [ NAD ]. Therefore, it is important~     to know the effect of resveratrol on the glycemic variability [GV ] in patients with T2DM who~     are not in control with metformin monotherapy based.~   "
77704|NCT02549911|"~     Explore the hyperthermic intraperitoneal chemotherapy (HIPEC) and intravenous chemotherapy~     for Creating the Operation Chance in advanced gastric cancer with peritoneal metastasis.~   "
77707|NCT02549872|"~     Most patients with dementia in the UK use their local hospitals and general (family)~     practices throughout their illness. Linked electronic health records from primary care,~     hospital and death certificates records therefore provide useful information about the~     diagnosis and prognosis of patients who develop dementia.~      In this study we will assess the validity of dementia diagnoses in linked primary care,~     hospital and death records, by examining the timing of important health transitions in~     patients with recorded dementia, and we will estimate the lifetime risk of recorded dementia~     in different age and sex groups~   "
77708|NCT02549859|"~     Our recent study (Xie et al, Neurology 2015; 84: 415-420) found that 60Hz stimulation,~     compared to the traditional 130Hz, decreased the aspiration frequency and swallowing~     difficulty, medication refractory freezing of gait (FOG), and other axial symptoms and~     parkinsonism in Parkinson patients with bilateral STN DBS. The benefit of 60Hz stimulation~     persisted during the 6-week study period, with worsening tremor in one patient. However, it~     remains unknown whether the benefit of 60Hz would persist on prolonged stimulation period,~     and whether there is carry-over effect across different conditions. Clarifying these~     questions is essential for the application of 60Hz stimulation chronically and confidently to~     treat medication refractory axial symptoms. Hence, the investigators would test the~     hypothesis that the 60Hz stimulation, compared to 130Hz, would have persistent benefit over~     an extended period (on average > 8-month study period) in reducing the swallowing~     dysfunction, FOG, and other axial symptoms in PD patients with bilateral STN DBS and~     medication refractory FOG at 130Hz stimulation, even after correcting the potential~     carry-over effects between stimulation conditions.~   "
77709|NCT02549846|"~     Investigators will study whether immediate statin treatment after the onset of stroke is~     beneficial on the neurological protection~   "
77710|NCT02549833|"~     This is a pilot neoadjuvant vaccine study in adults with WHO grade II glioma, for which~     surgical resection of the tumor is clinically indicated. Co-primary objectives are to~     determine: 1) the safety and feasibility of the neoadjuvant approach; and 2) whether the~     regimen increases the level of type-1 chemokine CXCL10 and vaccine-specific (i.e., reactive~     to GBM6-AD) CD8+ T-cells in tumor-infiltrating leukocytes (TILs) in the surgically resected~     glioma.~   "
77711|NCT02549820|"~     CDH is a birth defect characterized by the development, very early in gestation, of a hole in~     the diaphragm, the breathing muscle that separates the chest from the abdomen. As a result,~     the intestines and other organs in the abdomen can move into the chest and press on the~     developing lungs. This prevents the lungs from growing and developing normally.~      In severe cases, CDH can lead to serious disease and death at birth. For these babies,~     treatment before birth may allow the lungs to grow enough before birth so these children are~     capable of surviving and thriving.~   "
77712|NCT02549807|"~     Hemiplegic adults after stroke (stroke), children and adolescents with cerebral palsy (CP)~     have both muscles spastic and paresis. These movement disorders are likely to cause muscle~     changes both structural and viscoelastic involved in the alteration of neuromotor functions~     such as walking. Therefore, it seems interesting to study the structure of these muscles with~     available imaging techniques. The medial gastrocnemius muscle presents architectural~     characteristics which allows easy evaluation 2D ultrasound. The literature lacks data on the~     reproducibility of the measurement, by 2D ultrasound, of the pennation angle and muscular~     thickness, particularly in children. In addition, the sonoelastometry by Supersonic ShearWave~     Imaging (SSI) is a new technique of ultrasound, non-invasive, dynamic, which allows the~     calculation of the modulus of elasticity within a muscle tissue. This allows to consider new~     perspectives evaluation of the viscoelastic properties of the muscle. No studies have~     evaluated the reproducibility of this method in adults/children/ adolescent after stroke and~     hemiplegia.~   "
77713|NCT02549794|"~     According to CT technology development, cardiac CT is very useful examination as noninvasive~     examination and the accuracy in locating lesions has increased to 95%. Specifically, cardiac~     CT has been performing a gateway role in reducing invasive cardiac angiography implemented~     solely for the purpose of diagnosis because of the invasive testing of makeshift cardiac~     angiography. However, cardiac CT also comes with the disadvantage that patients cannot avoid~     being exposed to radiation, so there has been much effort in appealing to reduce exposed~     radiation dose. Of these methods, the most effective is the method of repeatedly~     reconstitution by way of synchronized prospective ECG while using low tube-based potential.~     According to recent studies, the SNR(Signal Noise Ratio) and CNR(Contrast Noise Ratio) values~     representing image quality have been higher compared to the combined method of image~     reconstruction by makeshift filtered back projection and condition of image acquisition by~     patient BMI. Also, the administered amount of contrast agent can be reduced for achieving the~     same contrast effect due to the advantage of the increased effect of contrast enhancement by~     using low tube voltage. Therefore, the efficacy studies of using low concentration of~     contrast agents in conditions of using low tube voltage are being processed.~      This study intends to prove that image quality does not deteriorate by suitable image~     reconstruction method with low concentration contrast agent compared to the combined method~     of the makeshift filtered back projection image reconstruction method and the conditions of~     image acquisition according to BMI with general amount of contrast agent.~   "
77714|NCT02549781|"~     In France, the prevalence of problem gambling and risk has been estimated at 1.3%. This~     disorder, currently considered a behavioral addiction is characterized by a loss of control~     and an excessive focus on the game.~      The literature on intervening psychological mechanisms in the development of the game led to~     think that the size of loss of control, central among players, could be understood as a~     reduction in control capacity but also as automatic activation behavior game.~      The task of Go-Nogo, commonly used in cognitive psychology, assesses the automatic and~     controlled components of behavior. Furthermore, different models of the concept of addiction~     underline the importance of the environment associated with addiction. However, no study~     takes into account the interaction between the game environment and the involvement of these~     mechanisms.~   "
77715|NCT02549768|"~     Use of dexmedetomidine in pituitary tumor resection surgery as adjuvant drug and its relation~     to cortisol levels during postoperative period.~   "
77716|NCT02549755|"~     It is thought that PET of the abdomen with 11C Acetate will provide new information regarding~     whether or not patient's have benefited from radiotherapy. To test this theory, the project~     will evaluate the potential of 11C acetate to serve as an earlier and/or better signal of~     treatment success.~   "
77718|NCT02549729|"~     The purpose of this study is to evaluate the effect of pelvic floor muscle training (PFMT) on~     muscle function of postmenopausal women using or not using hormonal therapy replacement~     (HTR). The study will evaluate also the prevalence of urinary incontinence reports, its~     severity and impact on quality of life.~   "
77719|NCT02549716|"~     This study compares the bioavailability of IV and PO acetaminophen in both blood and the~     cerebrospinal fluid (CSF) of patients following subarachnoid hemorrhage. The study will also~     compare the temperature and levels of inflammatory cytokines in both blood and CSF of~     patients treated with IV and PO acetaminophen.~   "
77720|NCT02549703|"~     While the last several years have seen great strides in the treatment of relapsing forms of~     MS, progressive MS, responsible for the majority of MS-related disability, lags far behind.~     Despite much research, the lack of understanding related to what causes patients' relentless~     decline in function results in an inability to develop targeted treatment strategies suitable~     for clinical trials. This grant has two main goals.~      The first goal is to extend the investigators preliminary study on rat neurons treated with~     the CSF of MS patients to a larger number of Progressive patients in order to validate the~     initial findings and extend the study to include analysis of human neurons. The initiating PI~     (Dr. Casaccia) and the Partnering PI and Clinical Neurologist (Dr. Katz Sand) have recently~     identified components that are present in the CSF of progressive patients that impair the~     ability of rat neurons to produce energy. The partnering PI, Dr. Quinzii (Columbia~     University) together with collaborator Dr. Fossati (NY Stem Cells Foundation), have~     characterized human neurons generated from stem cells derived from skin biopsies of~     progressive patients and detected the presence of energetic deficits. The experimental plan~     will build on these results and test hypotheses of disease progression. The overall goal is~     to improve understanding on how to stop neurons from degenerating and stop clinical~     progression.~      The second goal is to ask whether it is possible to define a progressive disease course on~     the basis of combined biochemical, functional and imaging measurements. The initiating PI~     will be responsible for the biochemical assessment of CSF and serum samples and, together~     with partnering PI Quinzii, will also provide functional bioassays measurements of~     mitochondrial bioenergetics impairment in patients. These data will be combined with clinical~     assessment and MRI evaluations conducted by the partnering PI Katz Sand and collaborator~     Inglese. A two year clinical and imaging follow up from the initial recruitment will allow to~     define whether the combined measurements can be used by clinical neurologists to define the~     disease course and better identify therapeutic options for patients.~      The expectation is that the completion of the stated aims of research will allow an~     advancement of the current knowledge of the progressive form of MS and lead to potential new~     therapeutic targets.~   "
77721|NCT02549690|"~     The main purpose of this study is to compare the number of oocytes retrieved after using~     transdermal testosterone gel 10 mg per day or Dehydroepiandrosterone (DHEA) 75mg per day for~     6-8 weeks as pre-treatment for poor ovarian responders undergoing in-vitro fertilization~     (IVF).~   "
77722|NCT02549677|"~     The purpose of this study is to compare the safety and efficacy of epirubicin plus~     cyclophosphamide versus docetaxel plus cyclophosphamide in lymph node negative, estrogen~     receptor (ER) positive, human epithelial growth factor receptor 2 (HER2) negative breast~     cancer patients as adjuvant chemotherapy.~   "
77723|NCT02549664|"~     The goal is to determine how lifestyle and exercise impact the well-being of individuals with~     hypertrophic cardiomyopathy (HCM) and long QT syndrome (LQTS).~   "
77724|NCT02549651|"~     The purpose of this study is to evaluate the safety, tolerability, and efficacy of MEDI4736~     (durvalumab) alone and in combination with either tremelimumab or AZD9150 in adult subjects~     with relapsed or refractory dIffuse large B-cell lymphoma.~   "
77725|NCT02549638|"~     The study will utilize both retrospective and prospective data collection from patients that~     already had a bronchoscopy and lung resection or will have a bronchoscopy and lung resection~     for squamous cell carcinoma. The investigators plan to prospectively collect 5 bronchoscopic~     biopsies, 10ml blood and one tumor and adjacent normal samples from 200 qualified patients~     who meet the study criteria.~   "
77726|NCT02549625|"~     The objective of this study is to determine the safety and feasibility of autologous~     mononuclear cells (MNC) collected from bone marrow (BM) and intracoronary delivery for~     individuals with declining ventricle systemic pumps. This procedure has the potential to~     foster a new strategy for congenital heart patients. This is an open-label study of~     autologous MNC derived from bone marrow with a 2-year follow-up to document 1) related~     serious adverse events and 2) monitor changes in cardiac structure and function.~   "
77727|NCT02549612|"~     Secretory otitis media (SOM) or middle ear effusion is a common finding after acute otitis~     media (AOM). It is usually associated with 5-15 deci Bells hearing loss. Although spontaneous~     resolution with normalisation of hearing is the usual outcome, this can take several months.~     Secretory otitis media is the most common cause of hearing impairment in the paediatric age~     group. When the hearing loss caused by SOM is bilateral and persists for 3-6 months or more,~     surgery with tympanostomy tube insertion under general anaesthesia is indicated. In Sweden,~     10000 children undergo this operation annually. Although many children with unilateral or~     bilateral SOM improve in the summer, the problem usually recurs in the autumn or winter. The~     cost of SOM for the Swedish society was 600 million Swedish crowns 2005.~      In two previous studies, the investigators concluded that the nonsurgical treatment method,~     that was developed to assist children with SOM equalising their middle ear pressure, could~     normalise the hearing level in 80 % of children with SOM of minimum duration of 3 months.~     These children avoided therefore grommet insertion.~      The investigators would like to assess the effect of this new treatment method on hearing~     directly after AOM. The investigators expect that using the new method could rapidly~     normalise hearing in these cases and thereby operation with grommet insertion could be~     avoided.~   "
77728|NCT02549599|"~     The primary aim of the proposed project is to conduct a randomized controlled trial to~     evaluate the efficacy of a digital intervention tool that enables young people to correspond~     with trained staff via online chat or text messages about urgent questions related to~     sexual/reproductive health.~   "
77729|NCT02549586|"~     This open-label, proof-of-principle two center cohort study will evaluate the ability of~     autologous hematopoietic stem cell transplantation to induce tolerance in recipients of~     deceased or live donor liver transplants (ASCOTT). A maximum of 10 participants will be~     entered at a minimum of 3 months post liver transplant. The participants will undergo~     autologous hematopoietic stem cell transplants (HSCT) to re-educate their immune systems to~     accept the graft without the need for long term immunosuppression (tolerance).~   "
77730|NCT02549573|"~     To determine if PT intervention will be improved while in the on motor state vs. the~     end-of-dose-off motor state during the PT Intervention Visit in subjects with PD.~   "
77779|NCT02548936|"~     This is a randomized single-blind trial. This study aimed to determine if intensive~     lipid-lowering therapy (simvastatin-ezetimibe combination therapy) could reduce the~     progression of atherosclerosis effectively and safely among SLE patients with carotid artery~     intima thickening. The study results were expected to be helpful for SLE patients in~     preventing atherosclerosis.~   "
77731|NCT02549560|"~     Postoperative cognitive dysfunction (POCD) is a contrary event observed between 20 to 83%,~     especially on elderly and patients submitted to cardiac surgery. The prevention and~     rehabilitation on cases of POCD can improve the quality of life and decrease the mortality in~     surgical patients. The effect of the noninvasive cerebral stimulation, also known as~     transcranial Direct Current Stimulation (tDCS) has been studied to be used in the treatment~     of brain injuries and depression, and also in the cognitive rehabilitation. The hypothesis is~     that the use of the tDCS technique can decrease the occurrence of POCD and cognitively~     rehabilitate patients submitted to cardiac surgeries.~   "
77732|NCT02549547|"~     The WHO, the Pan American Health Organization, the EU Council of Ministers, the World~     Federation of Mental Health, and the UK Royal College of Psychiatrists all agree -there can~     be no health without mental health. Within Canada, 6.7M people live with a mental illness~     and when family and caregivers are included almost everyone is affected.~      A systematic review (2014) concluded that physical activity has a significant potential for~     reducing depressive symptoms in people with a mental illness. Globally, physical inactivity~     is pandemic. Current guidelines recommend a minimum of only a 150 minutes a week of~     moderately vigorous exercise but 85% of Canadians do not meet the national recommendations.~     How then can people with depression be motivated to become physically more active?~      Group Medical Visits (GMVs) can be used to provide health services and they have proven~     effective in some settings, including mood disorders. As well as providing economic and~     resource efficiencies, the GMV model has the potential to add a 'support~     group/accountability' element for behavioural interventions such as physical activity~     promotion; such influence is not present in an individual patient-physician consultation.~      Jump Step is a 14-week program within a GMV setting designed to motivate and support people~     with depression to engage in regular physical activity. The investigators seek to design,~     implement, and evaluate the effectiveness of the Group Medical Visits focused on promoting~     physical activity for patients with depression.~   "
77733|NCT02549534|"~     Purpose: The purpose of the study is to test a new way of measuring nerve damage in women~     with breast cancer receiving chemotherapy drug paclitaxel (Taxol).~   "
77734|NCT02549521|"~     Calcium and vitamin D substitution has for a long time been used to improve osteoporosis.The~     main storage place for magnesium is in the bone. Magnesium is direct under calcium in the~     periodic system making it possible to interact with the crystal structure. Some small studies~     have shown beneficial effects of magnesium substitution on osteoporosis. Evidence has shown~     improvement with calcium, alcohol, fruit and vegetable nutrients on bone loss. It has been~     uncertain however, which of these factors can contribute to such a change. The effect of~     magnesium substitution 240 mg daily as therefore studied in two parallel groups where both~     received calcium carbonate 1000 mg/day and cholecalciferol 10 ug/day, one got placebo and the~     other received magnesium. This was studied on various expressions for bone metabolism after~     zero, seven and 28 days in elderly females aged 70 years old.~   "
77735|NCT02549508|"~     The purpose of this research is to examine the application of AutoCPAP with and without~     SensAwake in subjects with OSA and Post-Traumatic Stress Disorder (PTSD), and evaluate~     whether patients achieve better sleep quality and compliance with SensAwake, compared to the~     same treatment without SensAwake.~   "
77736|NCT02549495|"~     This study evaluates the effectiveness of community health workers when added to routine care~     for patients with diabetes and high blood pressure in rural clinics in Chiapas, Mexico. It~     does so by recording information on adherence to therapy, blood pressure and blood sugar~     while a non-governmental organization working in Mexico trains and introduces a community~     health worker program.~   "
77737|NCT02549482|"~     13 healthy volunteers (4 females) were tilted 45° head-up while breathing through a facemask~     fitted with an inspiratory and expiratory resistor. A brachial arterial catheter was used to~     measure blood pressure and thus systolic pressure variation and pulse contour analysis~     determined stroke volume and thereby cardiac output in order to detect a central volume~     deficit.~   "
77738|NCT02549469|"~     Bioequivalence trial in healthy adult subjects to determine the bioavailability of 3~     different sustained release formulations of naproxen 660 mg relative to the established~     commercial Aleve 220 mg tablet.~   "
77739|NCT02549456|"~     The purpose of this study is to assess different hybrid natural orifice transluminal~     endoscopic surgery techniques in management of colorectal cancer as regard: feasibility of~     the technique, short term oncologic outcome and functional outcome.~   "
77740|NCT02549443|"~     This study evaluates whether providing a nutritional intervention in the form of insulin,~     sugar and protein during and after open-heart surgery will increase the body's protein stores~     and maintain a normal level of blood sugar. The primary outcome will be Whole body protein~     balance which will be assessed by isotope tracer kinetics. Protein balance will be calculated~     as protein synthesis minus protein breakdown with positive values indicating anabolism and~     negative values catabolism. The preoperative measurements will be performed on the morning~     before the operation. Postoperative studies will be conducted two hours after surgery in the~     intensive care unit. Patients will be followed for 12 hours after surgery.~   "
77741|NCT02549430|"~     This study aims to assess the activity of PD0332991 in monotherapy and in combination with~     the endocrine therapy (anastrozole, letrozole, exemestane or fulvestrant) on which the~     patient has progressed in the previous line for advanced breast cancer in order to reverse~     endocrine resistance.~   "
77742|NCT02549417|"~     This study is designed to evaluate efficacy and safety of KHK7580 orally administered once~     daily for 32 weeks for patients with secondary hyperparathyroidism receiving peritoneal~     dialysis. After 32-week treatment period, the subjects will receive KHK7580 in the 20-week~     extension period to evaluate long-term safety and efficacy.~   "
77743|NCT02549404|"~     This long-term study is designed to evaluate safety and efficacy of KHK7580 orally~     administered once daily for 52 weeks for patients with secondary hyperparathyroidism~     receiving hemodialysis.~   "
77744|NCT02549391|"~     The purpose of this study is to evaluate the efficacy and safety of KHK7580 orally~     administered once daily for 30 weeks in subjects with secondary hyperparathyroidism (SHPT)~     receiving hemodialysis in a randomized, double-blind, intra-subject dose-adjustment,~     parallel-group design with cinacalcet hydrochloride as an active control.~   "
77780|NCT02548923|"~     The purpose of this study is to assess the efficacy of dexmedetomidine versus propofol for~     prolonged sedation in trauma and surgical patients.~   "
77745|NCT02549378|"~     The microcirculatory alterations is common in circulatory failure, especially during sepsis.~     The severity of these changes and their sustainability are responsible of multi organ failure~     and ultimately death. The optimization of microcirculatory flow could be a central objective~     of the management of patients hospitalized in intensive care.~      Microcirculation includes all blood vessels of a diameter smaller than 100 micrometer. It~     represents the largest heat exchange surface of the body and is involved in tissue~     oxygenation. Microcirculatory flow is conditioned by the macrocirculation (heart rate and~     blood pressure) and the state of the microcirculation (thrombosis, vasoconstriction ...). The~     role of the CO2 in regulating microcirculatory flow is little studied. A recent work of our~     team and the oldest work in the literature lead to believe that CO2 has a specific role in~     modulating microcirculatory flow. No study to date precisely studied the impact of changes in~     the microcirculatory flow carbonemia .~      The hypocapnia test is carried out in a standardized manner by inhalation of a mixture~     enriched in CO2 7% allows a significant increase in carbonemia. Hypocapnia will in turn~     obtained by a calibrated voluntary hyperventilation test.~      Direct visualization of microcirculation by confocal microscopy is now considered the gold~     standard for exploring the microcirculation.~   "
77746|NCT02549365|"~     The UK Departments of Health now recommend annual influenza vaccination for all children 2-7~     years of age, with children over 7 years eligible for vaccination if in certain higher risk~     clinical categories. Though data are available documenting the safety and immunogenicity of~     LAIV in this age group, there are little data to assess efficacy and immune correlates in UK~     children, and in particular atopic children. This study will enrol 200 children (and at least~     200 unvaccinated household sibling controls), many with a history of asthma or recurrent~     wheezing, and allow an assessment of efficacy, safety and immune correlates in these~     children, and how this varies with prior administration of pandemic influenza vaccine and/or~     LAIV.~   "
77747|NCT02549352|"~     The objective of the trial is to compare the short term efficacy of LEO 43204 gel with~     vehicle gel in AK on the balding scalp when applied topically once daily for 3 consecutive~     days as field treatment~   "
77748|NCT02549339|"~     The objective of the trial is to compare the short term efficacy of LEO 43204 gel with~     vehicle gel in AK on face or chest when applied topically once daily for 3 consecutive days~     as field treatment~   "
77749|NCT02549326|"~     Obesity is associated with lower total serum 25-hydroxycholecalciferol (S-25OHD)~     concentration. However, the impact of obesity on free S-25OHD is inadequately studied. A~     direct assay for free 25OHD was introduced recently.~      The aim of the study was to evaluate differences in vitamin D metabolism between young adults~     with severe childhood-onset obesity and normal-weight controls. Half of the obese subjects~     and controls will receive placebo and the other half will receive vitamin D3 50 µg daily for~     12 weeks.~   "
77750|NCT02549313|"~     The position of the head of the patient influences the cerebral venous return and cerebral~     perfusion pressure (CPP). In our daily practice, it is almost routine to prescribe a~     Trendelenburg position 30 ° in all brain-damaged patients. However, this is based only on~     precarious bibliographic databases. It has been shown to decrease the Intracranial Pressure~     (ICP) in Trendelenburg position relative to the horizontal, with varying effects on PPC.~     Effects on sylvian objectified by Doppler velocities and cerebral oxygenation seem unaffected~     by changes of position of the head of the patient. But the whole of the literature on this~     subject has significant bias.~   "
77751|NCT02549300|"~     The purpose of this study is to investigate the effects of connective tissue massage and~     lifestyle modifications in adolescents tension type headache, pain severity, pain duration,~     pain frequency and quality of life and pressure pain threshold rates. The patients will be~     accepted to study according to 'The International Classification of Headache Disorders-III'~     criteria. Including criteria are; being between 10-19 ages adolescents, suffering from~     tension type headache at least for 6 months, pain severity between 4-7 on visual analog~     scale. Excluding criteria are; current pregnancy, having any history of cancer, traffic~     accident, head trauma and any kind of neurological disorder. Patients will be divided into~     two groups randomly. The investigators plan to receive 30 patients to the study. 15 of them~     will be in control group, 15 in study group. Control group will just receive some advices~     including life style modifications, like using right glasses, not smoking, true posture~     habits and regular and quality sleep habits. In addition to life style modifications, the~     other group will be treated with connective tissue massage. Connective tissue massage will be~     applied on basic part, lower thoracic, scapular, inter scapular and neck regions, 5 times a~     week, totally 20 sessions in a month. Each session lasts approximately 20-30 minutes.~     Patients detailed medical history and demographic data will be recorded. Pain severity,~     duration, frequency, analgesic usage, connective tissue evaluation of back, range of motion~     of neck, pressure pain threshold for pain sensitization measurements and quality of life will~     be evaluated before treatment and after 4 weeks of treatment.~   "
77752|NCT02549287|"~     The purpose of this study is to conduct an effectiveness trial of the SafeCare model for~     parents with substantiated maltreatment. SafeCare, a behavioral parenting program will be~     compared to supportive case management (SCM), which is a process oriented service aimed at~     building rapport, providing family support, crisis management, and provision of referrals to~     additional services. The SafeCare model is a promising intervention for child maltreatment,~     but has not been broadly compared to usual services across a variety of service setting, and~     it has not been evaluated with respect to client outcomes of well-being, or service delivery~     burden, satisfaction, and perceived effectiveness. The study aims are as follows:~      (1) Compare SafeCare to SCM on parent and child outcomes including parenting skill, parenting~     stress and emotional well-being, parent-child relationship, parent and child well-being, and~     child adaptive behavior. (2) Compare SafeCare to SCM on how families and providers perceive~     each intervention, specifically with regard to burden, satisfaction, and program impact. (3)~     Compare SafeCare to SCM on ability to reduce child welfare re-reports. (4) Examine~     variability in SafeCare effects across sites and client characteristics.~   "
77781|NCT02548910|"~     Major liver resection is associated with substantial intraoperative blood loss. Blood loss in~     elective liver surgery is a significant factor of perioperative morbidity and mortality, as~     well as possibly long-term oncologic outcome. The purpose of this study is to use whole blood~     phlebotomy to decrease the central venous pressure, resulting in a state of relative~     hypovolemia. It is hypothesized that this intervention will lead to a decrease in blood loss~     at the time of liver resection.~   "
77753|NCT02549274|"~     The prevalence of non-specific neck pain is 12.1 / 1000 patients / year. Their support is~     most often based on analgesics combined with physical therapy. More recently authors have~     advocated the use of self-rehabilitation, that is to say, the use by the patient himself of~     physiotherapy exercises to perform at home regularly. However, if there are currently many~     studies on the effectiveness of self-rehabilitation for low back pain, there are few data on~     neck pain.~      In this context we have chosen to implement a prospective, randomized study, on the~     effectiveness of self-rehabilitation in patients with chronic neck pain.~   "
77754|NCT02549261|"~     Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located~     in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical~     efficacy has been shown in adult with head and neck cancer. The study assessed the efficacy~     and safety of the combination of Nimotuzumab administered concomitantly with~     chemoradiotherapy in patients with NSCLC .There is a tolerance trial of Nimotuzumab in~     Combination With Radiochemotherapy treatment before the randomization,double~     blind,muti-center sites trial of this treatment.~   "
77755|NCT02549248|"~     Nanoparticles (NP) are particles whose length, width and height are less than 100 nanometres.~     Over the past decade, industrial applications of NP have increased dramatically. Despite~     their widespread use, their true impact on human health remains unknown and poorly studied.~     NP exposure in humans primarily occurs via inhalation through the respiratory system. The aim~     of this study is to estimate the relationships between the nanoparticle load in the lung and~     bronchi and some interstitial lung diseases. In the aftermath of human exposure to asbestos,~     the pathological consequences of environmental exposure to nanomaterials could be evaluated~     upon a mineralogical analysis of pulmonary samples.~   "
77756|NCT02549235|"~     The purpose of this trial is to evaluate the morphological characteristics of the uterus with~     three-dimensional ultrasound (3DUS) at the time of embryo transfer in women undergoing~     IVF/ICSI treatment and correlate it to clinical outcomes. The uterus will be assessed in the~     3D coronal plane and measurements including the fundal wall thickness, fundal wall~     indentation and interostial distance will be performed to assess whether they correlate with~     clinical pregnancy rate, miscarriage rate and live birth rate.~   "
77757|NCT02549222|"~     This study is a prospective, non-randomized sequential cohort, open label, multi-center,~     non-inferiority, Phase IV surveillance study following transfusion of INTERCEPT PCs. The~     patient population will be hematology-oncology patients, including those undergoing~     hematopoietic stem cell transplant (HSCT), expected to require one or more PC transfusions.~      For each participating center, the study will start with a brief pilot run-in period with a~     group of at least 5 patients exposed only to conventional PCs. The purpose of this pilot~     run-in is to evaluate study logistics and data collection methods within each study center.~     Data from the pilot phase will be included in the data listings but not included for the~     treatment comparison.~      After the pilot run-in period, the study will be conducted in two sequential patient cohorts:~     1) the Control cohort during which study patients will receive only conventional PCs, and 2)~     the INTERCEPT cohort during which patients will receive only INTERCEPT PCs. Patient~     enrollment at each Center will be monitored to target similar numbers of patients into the~     Control and Test Cohorts within each center. Within each Center, patient enrollment will be~     stratified in four categories: (1) chemotherapy only; and by use of conditioning regimens for~     hematopoietic stem cell transplantation (HSCT) in (2) myeloablative conditioning, (3)~     non-myeloablative conditioning, and (4) reduced intensity using the Center for International~     Blood and Marrow Transplant Research (CIBMTR) criteria. To ensure both Test and Control~     cohorts have a similar allocation ratio (±10% per category) among the conditioning regimen~     strata, enrollment caps will be set for the Test cohorts, hence no Test patients will be~     enrolled to a stratum once the cap for the given stratum is met.~   "
77758|NCT02549209|"~     This is a single-arm, open-label, multi-center phase II study for subjects with measurable~     advanced or recurrent endometrial cancer using pembrolizumab in combination with carboplatin~     and paclitaxel chemotherapy. As this combination of agents has not been tested in this~     subject population, the first six subjects enrolled will constitute a safety run-in cohort.~   "
77759|NCT02549196|"~     This is a Phase II, ascending dose study of CPC-201 in patients with dementia of Alzheimer's~     type to determine the optimal dose titration schedule.~   "
77760|NCT02549183|"~     Clinical study to estimate the optimal frequency for stimulation of the spinal cord to~     achieve relief from back pain.~   "
77761|NCT02549170|"~     This is a Phase III, prospective, multicenter study with two study parts (epochs) to evaluate~     the efficacy, safety, and tolerability of HYQVIA/HyQvia (IGI, 10% with recombinant human~     hyaluronidase (rHuPH20) administered subcutaneously) for maintenance therapy to prevent~     relapse (Epoch 1) and GAMMAGARD LIQUID/KIOVIG (immunoglobulin G intravenous (IGIV) 10%~     administered intravenously) for the treatment of CIDP (Epoch 2). This study will enroll adult~     subjects with a confirmed diagnosis of CIDP and who have remained on a stable dosing regimen~     (monthly equivalent dose of 0.4 to 2.4 g/kg body weight (BW) with a dosing interval of 2 to 6~     weeks) of IGIV therapy for at least 12 weeks prior to screening. In this double-blind,~     placebo-controlled phase of the study (Epoch 1), eligible subjects will be randomized in a~     1:1 ratio to receive either HYQVIA/HyQvia or 0.25% albumin placebo solution with rHuPH20~     every two, three, or four weeks in a double-blind fashion for a period of 6 months or until~     relapse. Subjects who relapse during Epoch 1 will enter Epoch 2 to receive IGIV treatment for~     a period of 6 months.~   "
77782|NCT02548897|"~     The purpose of this study is to investigate brain signals related to freezing of gait (FoG),~     a symptom of Parkinson's Disease, that can lead to dangerous falls. The investigators~     hypothesize that uncovering these signals can lead to better deep brain stimulation~     interventions.~   "
77783|NCT02548884|"~     The purpose of the study is to compare two different techniques (pancreatic sphincterotomy~     (PS) and double wire technique (DGW)) regarding the risk of post-ERCP pancreatitis (PEP) and~     the success of cannulation in difficult cannulation. For the study, the difficult cannulation~     is de-fined as situation when the common bile duct has not been cannulated in five minutes,~     after five attempts or after two pancreatic guide wire passages or when any of those limits~     is exceeded. The two techniques, the PS and the DGW, will be compared in random fashion. The~     primary end-point is the risk of PEP .~   "
77784|NCT02548871|"~     The purpose of this study was to determine the impact of TOP® on sexual health behavior.~   "
77762|NCT02549157|"~     The research aims to assess the relationship between treatments for a range of~     urogynaecological problems (pelvic floor dysfunction, cancers) and patient reported values,~     psychological states, and quality of life. The impact of treatments on the patients' health~     outcomes will be measured, using specific urogynaecological outcome measures (for either~     pelvic floor dysfunction or cancer), and patient reported measures of general health and~     quality of life. Patients' psychological states and values will be measured by validated self~     report instruments for these areas. Researchers will obtain consent for participation from~     patients. Following consent, baseline measures will be taken at the patients' routine~     appointment about 4weeks prior to undergoing treatment (e.g., surgery or physiotherapy for~     pelvic floor dysfunction, or surgery for a urogynaecology cancer). These measures will be the~     routinely collected physical data obtained by medical staff, and patient reported measures of~     their general health (GHQ28), psychological state (HADS; PVQII), and quality of life~     (EuroQual5D, WHOQoLBREF, QRS, QLQC30). These questionnaires should take about 30 minutes to~     complete, in total. The patients will then undergo their treatment (physiotherapy programme~     or surgery), which will not be affected in any way by this research. Researchers will obtain~     consent for participation from patients. Following consent, baseline measures will be taken~     at the patients' routine appointment about 4 weeks prior to undergoing treatment (e.g.,~     surgery or physiotherapy for pelvic floor dysfunction, or surgery for a urogynaecology~     cancer). These measures will be the routinely collected physical data obtained by medical~     staff, and patient reported measures of their general health (GHQ28), psychological state~     (HADS; PVQII), and quality of life (EuroQual5D, WHOQoLBREF, QRS, EORTC QLQC30). These~     questionnaires should take about 30 minutes to complete, in total. The patients will then~     undergo their treatment (physiotherapy programme or surgery), which will not be affected in~     any way by this research. About four weeks post treatment, patients will receive their usual~     appointment, and routinely collected physical data will be obtained by medical staff, and~     patients will complete the measures as described above. With the patient's consent, the above~     evaluation will be repeated at every follow-up appointment that the patient has (i.e. after~     3months, and then at yearly intervals, for 5 years). The impact of treatments on objective~     routine health measures taken by medical staff, and on patient reported measures of health,~     quality of life, personal values, and psychological functioning, will be documented at each~     measurement point. Additionally, relationships between psychological states/values and both~     objective and subjective ratings of how treatments have impacted the patients will be~     established.~   "
77763|NCT02549144|"~     In this study the investigators aimed at measuring the effect of a two-week~     high-fat/high-cholesterol (HFHC) normocaloric diet on HDL particles biochemical composition~     and HDL function compared to a two-week low-fat/low-cholesterol (LFLC) normocaloric diet.~   "
77764|NCT02549131|"~     The purpose of this randomized controlled prospective trial is to guide physicians on the~     most effective evidenced based skin closure during a cesarean section for the obese gravida,~     defined as a BMI of 40 or greater. The study will compare two closure methods: subcuticular~     sutures and surgical staples.~   "
77765|NCT02549118|"~     The aim of this study is to assess whether tenoxicam is as effective as pethidine for~     analgesia during the first stage of labor.~   "
77766|NCT02549105|"~     A Comparison Between Lidocaine-Prilocaine Cream (EMLA) Application And wound Infiltration~     with Lidocaine For Post Caesarean Section Pain Relief : A Randomized Controlled Trial.~   "
77767|NCT02549092|"~     The primary objective of this study is to examine the effect of Levodopa-Carbidopa Intestinal~     Gel (LCIG) relative to that of OMT on non-motor symptoms associated with Parkinson's disease~     (PD).~   "
77768|NCT02549079|"~     The present study investigates the levels of certain soluble factors in the blood of patients~     with severe burn injury. Serum levels of different soluble factors will be correlated with~     the clinical outcome, presence of sepsis, the area of burn, and other clinical parameters in~     order to make a statement regarding their use as biomarkers in the prediction and monitoring~     of burn patients.~   "
77769|NCT02549066|"~     Cardiac surgery with cardiopulmonary bypass (CPB), especially when oxygen delivery is low, is~     associated with acute kidney injury. Unpublished data shows that renal oxygen delivery is~     compromised during CPB due to low hematocrit and redistribution of blood flow away from the~     kidneys. We wish to study if increased CPB flow can improve renal oxygenation.~      Patients who develop cardiac failure after weaning from CPB will be treated as per our~     departments routine with the inotropic agent milrinone, and measurements will be made before~     and after treatment.~   "
77770|NCT02549053|"~     The aim of this study was to determine whether the prevalence of Human PapillomaVirus (HPV)~     was increased in patients with Barrett esophagus compared with controls in a prospective~     study. Secondary objective was to identify, if present, the type of Human PapillomaVirus~     (HPV) associated in Barrett esophagus.~   "
77771|NCT02549040|"~     This study aims to evaluate and compare the relative bioavailability of different MK-1439~     experimental nano formulations (NFs) with that of a MK-1439 film coated tablet.~   "
77772|NCT02549027|"~     The purpose of this randomized, double-blind, placebo-controlled, 5-period crossover study is~     to assess the effect of single oral doses of MK-1064 on latency to persistent sleep (LPS) as~     measured by polysomnography (PSG) in healthy young male participants, and to evaluate the~     safety and tolerability of single oral doses of MK-1064 and MK-6096 in healthy young male~     participants. The primary efficacy hypothesis is that at least one dose of MK-1064 is~     superior to placebo in decreasing LPS in healthy male participants as assessed by PSG.~   "
77773|NCT02549014|"~     The purpose of this randomized, double-blind, placebo-controlled study is to evaluate the~     safety, pharmacokinetics and pharmacodynamics of rising, single oral doses MK-1064 in~     healthy, young, male participants. The primary pharmacokinetic hypothesis is that at least~     one dose of MK-1064 that is generally safe and well tolerated produces an average MK-1064~     plasma concentration from 0 to 4 hours of ≥2.2 μM. Since this is an early Phase I assessment~     of MK-1064 in humans, the study protocol allows for modifications to the outlined dose,~     dosing regimen and/or clinical or laboratory procedures, if required to address study~     objectives and/or to ensure appropriate safety monitoring of participants.~   "
77774|NCT02549001|"~     The purpose of this study is to determine whether P-3058 nail solution is a safe and~     effective treatment for onychomycosis.~   "
77775|NCT02548988|"~     The purpose of this study is analyze the immediate effect of selective neuromuscular~     electrical stimulation of vastus medialis obliquus (VMO) in the electrical activity of VMO~     and vastus lateralis (VL) and in the isokinetic performance of women with patellofemoral pain~     syndrome.~   "
77776|NCT02548975|"~     This study will evaluate several potential risk factors for postoperative delirium in cardiac~     surgery patients. The risk factors will include use of specific preoperative, intraoperative,~     and/or postoperative medications. Other risk factors investigated may include exposure to~     cardiopulmonary bypass, surgical technique, and or duration of surgery.~   "
77777|NCT02548962|"~     Phase 1 will be an open-label, dose finding, multicenter study of ibrutinib in combination~     with pomalidomide and dexamethasone in subjects with relapsed/refractory multiple myeloma.~      Phase 2b will be conducted as a randomized, double-blind, multicenter study of ibrutinib or~     placebo, in combination with pomalidomide and dexamethasone in subjects with~     relapsed/refractory multiple myeloma.~   "
77778|NCT02548949|"~     On 6 Feb 2014, Pristiq was approved for the treatment of Major Depressive Disorder(MDD) in~     Korea. In accordance with the Standards for Re-examination of New Drug, it is required to~     conduct a PMS for 600 patients by 5 Feb 2020. Post marketing surveillance is required to~     determine any problems or questions associated with Pristiq after marketing, with regard to~     the following clauses under conditions of general clinical practice. Therefore, through this~     study, effectiveness and safety of pristiq will be observed.~   "
77786|NCT02548845|"~     In 2014, the Spanish Sociedad Española de Oncología Médica (SEOM) algorithm for the treatment~     of hyponatraemia secondary to to syndrome of inappropriate antidiuretic hormone (SIADH) in~     oncology patients was developed. Since it is hypothesised that the adherence to the SEOM~     algorithm is not 100%, the current retrospective non-interventional study will investigate~     the perceived and actual adherence of participating centres to the SEOM algorithm and its~     impact on patient outcomes~   "
77787|NCT02548832|"~     Dyslipidemia, is a cardiovascular risk factor of great importance whose prevalence has~     increased over the last decade. Part of the components of metabolic syndrome and consensus so~     far contemplated to increased triglycerides and reduced HDL-C as part of the elements for~     classification, which includes mixed dyslipidemia.~      Currently fibrates, such as bezafibrate, are drugs whose utility in treating~     hypertriglyceridemia is fully proven, besides reducing the risk of coronary disease. However,~     although this treatment is safe, it is not without risks; with increased prevalence of~     adverse effects as the dose thereof is increased or joins combination with a statin drug for~     the treatment of mixed dyslipidemia long term.~      Among the alternative therapies is berberine, which to reduce cholesterol and triglycerides~     may be useful in combination with the bezafribrato in the treatment of mixed dyslipidemia and~     as an option with lower cost and lower frequency of adverse events.~   "
77788|NCT02548819|"~     A single-center registry to prospectively evaluate the safety of non-cardiac/non-thoracic~     magnetic resonance imaging (MRI) in patients with implanted cardiac devices (pacemakers and~     implantable cardioverter defibrillators).~   "
77789|NCT02548806|"~     The purpose of this study is to determine the pharmacokinetic dose proportionality of 50 μg~     and 100 μg Clonidine and comparative bioavailability of clonidine with that from the~     Reference drug, Catapres® 100 μg oral tablets following single dose administration in healthy~     subjects.~   "
77790|NCT02548793|"~     Prompt delivery of cardiopulmonary resuscitation (CPR) is a crucial determinant of survival~     for many victims of sudden cardiac arrest (SCA), yet bystander CPR is provided in less than~     one third of witnessed SCA events. A number of barriers to bystander CPR training have been~     identified including time and cost of the training course. Since the large majority of arrest~     events occur in the home environment, studies have suggested that providing CPR training to~     family members of hospitalized cardiac patients may serve as a useful approach to address an~     environment in which bystander CPR is frequently not provided. Utilizing an existing~     in-hospital program to train adult family members, the investigators will assess the skills~     of those who learn CPR through two different educational methods: a mobile app and video~     self-instruction (VSI).~   "
77791|NCT02548780|"~     The primary purpose of the study is to evaluate the pharmacokinetic profile, safety, and~     efficacy of LifePearl™ microspheres loaded with Doxorubicin in the treatment of unresectable~     HCC.~   "
77792|NCT02548767|"~     It is not known whether consumption of excessive amounts of sugar can increase risk factors~     for cardiovascular disease or diabetes in the absence of increased food (caloric) intake and~     weight gain, nor whether the negative effects of sugar consumption are made worse when~     accompanied by weight gain. This study will investigate the effects of excess sugar when~     consumed with an energy-balanced diet that prevents weight gain, and the effects of excess~     sugar when consumed with a diet that can cause weight gain. The results will determine~     whether excess sugar consumption and excess caloric intake that lead to weight gain have~     independent and additive effects on risk factors for cardiovascular disease or diabetes, and~     will have the potential to influence dietary guidelines and public health policy.~   "
77793|NCT02548754|"~     Atrial fibrillation (AF) is the most common cardiac arrhythmia. In previous experimental~     studies, the investigators found that low-level vagus nerve (VN) stimulation (LLVNS), at~     voltages substantially below that which slowed the sinus rate, significantly suppressed AF~     inducibility and decreased AF duration. The investigators subsequently developed a~     non-invasive neuromodulatory therapy, in which LLVNS was delivered to the auricular branch of~     the VN located at the tragus, the anterior protuberance of the outer canine ear (low level~     tragus stimulation; LLTS). The anti-arrhythmic effects of LLTS were similar to those of LLVNS~     delivered to the cervical VN trunk. More recently, in a proof-of-concept study in humans, the~     investigators showed that in patients with drug-refractory AF undergoing AF ablation, LLTS~     for just one hour significantly shortened the AF duration and decreased inflammatory~     cytokines.~      The overall objective of this proposal is to translate in ambulatory patients with paroxysmal~     AF the results of previous studies showing acute suppression of AF and inflammation in~     anesthetized canines as well as humans, in order to examine the long-term therapeutic effects~     of this approach. The investigators hypothesize that intermittent (1 hour daily) LLTS for 6~     months may result in long-term decrease of AF burden and suppression inflammatory cytokines~     in patients with paroxysmal AF. Patients will be randomized to either active or sham LLTS.~     LLTS will be delivered through a transcutaneous electrical nerve stimulation (TENS) device~     for 1 hour daily over a 6-month period. AF burden will be defined as the percent of time~     spent in AF over a 2-week period, assessed by noninvasive continuous ECG monitoring at~     baseline and at 6 months. In addition, blood samples will be collected from patients at~     baseline, and at 3 and 6 months, for cytokine measurement. These investigations will~     establish the first evidence of the long-term effects of LLTS on AF suppression in patients~     with paroxysmal AF and may provide the basis for a potential expansion of the therapeutic~     targets of this treatment modality beyond AF.~   "
77794|NCT02548741|"~     This study is designed to investigate the effects of metformin, a commonly prescribed first~     line medication for diabetes and recommended for prediabetes, on the levels of the~     potentially tissue damaging reactive product (MG) in the blood and its cleared counterpart in~     the urine (IMZ). The study will involve patients with elevated HbA1c randomized to receive~     either metformin or a similar inactive placebo pill and a group of sex and age matched~     volunteers without diabetes. Study participants will be recruited from the University of~     Arizona Medical Center, South Campus clinics (Endocrine clinic, family medicine clinic and~     general medicine clinic). Eighty patients with HbA1c >6.0% will be randomized to receive~     either metformin or a similar inactive placebo for 6 weeks. The response of these patients~     will be compared to 40 patients normal HbA1c <5.6% who will not receive either study~     medication. Investigators will compare the plasma MG and urine IMZ concentration/content~     between the 3 groups before and after the 6-week intervention. It is hypothesized that plasma~     MG level in the metformin treatment group will be less than in the group taking the placebo~     pills, while there will be no significant difference in MG level between the metformin~     treatment group and the volunteers without diabetes.~   "
77795|NCT02548728|"~     Purpose: The purpose of this research study is to learn whether oxytocin treatment decreases~     use of and cravings for opioids (narcotics) in people who have been using opioids heavily for~     long periods of time and are unable to stop on their own.~      Participants: Patients meeting DSM-IV-TR criteria for opioid dependence.~      Procedures (methods): Subjects will have standard medications available for withdrawal~     symptoms from opioids and standard psychosocial interventions available in the inpatient~     setting. In addition, subjects will self-administer intranasal test treatments 3 times daily.~   "
77796|NCT02548715|"~     Patients that require treatment for cancers of the head and neck often require a combination~     of surgery and/or radiation and chemotherapy. Hypothyroidism is one of the most common~     complications, and has been associated with post-operative complications such as wound~     healing problems, fistula formation, and decreased quality of life and survival. Several~     studies have examined hypothyroidism after radiation to the head and neck, but few have~     examined this after non-thyroid head and neck surgery. Head and neck resection is theorized~     to devascularize the thyroid, thus resulting in post-operative hypothyroidism.~      Synthroid is a synthetic thyroid hormone often used in cases of patients with proven~     hypothyroidism and after surgical thyroid removal. It's use has been in effect and studied~     for over fifty years.~      Treatment algorithms for hypothyroidism are well published. However, treatment of subclinical~     hypothyroidism (elevated TSH with normal or near-normal T3/T4) is controversial. The rate of~     subclinical hypothyroidism after non-thyroid head and neck surgery is high (up to 20%), and~     is associated with post-operative complications as noted above.~      Therefore the investigators propose a double blinded randomized controlled trial comparing~     outcomes of patients that develop subclinical hypothyroidism after head and neck surgery, who~     are given a standardized dose of synthroid treatment versus those treated with placebo. The~     main outcomes to be examined are post-operative complications (wound healing issues, fistula~     formation), survival, and quality of life measures.~   "
77797|NCT02548702|"~     The Fit4Life intervention aims to engage inactive patients with type 2 diabetes in a~     community-based sport intervention, with the aim being that all participants complete 1 x 30~     min session of physical activity/exercise per week across the 12 months they are involved in~     the intervention (total study duration 3 years).~      The aim of the Fit4Life intervention is to slow the progression of disease symptoms and to~     improve quality of life in those diagnosed with type 2 diabetes. The aim of this research~     study is thus to evaluate the effectiveness of the intervention in achieving these aims. The~     hypothesis is that involvement in the Fit4Life programme will increase physical activity,~     reduce type 2 diabetes disease symptoms and enhance self-reported quality of life in male and~     female patients aged 35-64.~   "
77798|NCT02548689|"~     This study will investigate whether subjects who suffer from hair loss have increased levels~     of PAI-1 compared to age-matched control subjects. The level of PAI-1 expression will be~     determined in subjects without hair loss and in subjects with non-scarring hair loss,~     including androgenetic alopecia, telogen effluvium and alopecia areata.~   "
77799|NCT02548676|"~     Glaucoma is one of the leading causes for blindness in industrialized countries. It is~     characterized by a progressive loss of retinal ganglion cells, morphological changes in the~     optic nerve head and a characteristic loss of visual field. It has been speculated for a long~     time that vascular factors may also contribute to the pathogenesis of the disease. This~     concept has been supported by several epidemiological studies showing that small retinal~     vessel calibre are associated with the disease. In the recent years tremendous enhancements~     in the field of optical coherence tomography has been achieved. These developments made it~     possible to visualize the retinal vasculature in a full depth manner without the application~     of an intravenous marker. The proposed study tests the hypothesis that patients with glaucoma~     show altered vascular morphology compared to healthy subjects. This is of importance because~     it may clarify the degree of vascular involvement in glaucoma.~   "
77800|NCT02548663|"~     This project assessed muscle oxidative metabolism and fatigue in patients affected by~     amyotrophic lateral sclerosis (ALS) undergoing to three months of individualized~     cardiovascular and strength training. Muscle oxidative metabolism and strength will be~     assessed by non-invasive methods, such as near-infrared spectroscopy (NIRS) and~     mechanomyography (MMG). NIRS is a technique giving indications on the capacity of oxygen~     extraction of muscles during exercise. MMG allows analyzing the pattern of motor unit~     recruitment and related fatigue. The investigators will also assess the effects of training~     on pain tolerance and quality of life (QoL) by the Brief Pain Inventory and the McGill~     Quality of Life questionnaires, using the validated Italian versions. Patients will be~     assessed longitudinally before (time T0) and after three months of individualized training~     (time T1). After one month of de-training (time T2) the investigators will assess the~     hypothetic persistence of any treatment-related effect. The effect of three~     months-osteopathic treatment (osteo) on pain and QoL will be assessed as well.~   "
77801|NCT02548650|"~     Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 receptor inhibitor, more frequently~     clopidogrel, represents the standard of care for the long-term secondary prevention of~     atherothrombotic events in patients with myocardial infarction (MI) or peripheral arterial~     disease (PAD). However, rates of ischemic recurrences remain high. Vorapaxar is a~     protease-activated receptor (PAR)-1 inhibitor, which exerts potent inhibition of~     thrombin-mediated platelet aggregation. Patients with diabetes mellitus (DM) are known to be~     at increased risk of recurrent atherothrombotic events, which translates into worse outcomes,~     despite the use of standard of care therapy. This is in part due to the hyperreactive~     platelet phenotype, which characterizes DM patients, and to inadequate response to oral~     antiplatelet agents, including clopidogrel. Therefore, vorapaxar is an attractive treatment~     option for DM patients with a prior MI. The pharmacodynamic (PD) effects of vorapaxar in DM~     patients and how these may differentiate from non-DM patients has not been explored. Further,~     the role of vorapaxar as part of a dual antithrombotic treatment regimen combined with~     clopidogrel (and stopping aspirin) represents another important area of clinical interest.~     The proposed prospective, parallel-design study conducted in patients post-MI or with PAD~     with and without DM will aim the assess the pharmacodynamic effects of vorapaxar in addition~     to standard DAPT with aspirin and clopidogrel as well as in combination with clopidogrel only~     following aspirin withdrawal.~   "
77802|NCT02548637|"~     Researchers at the John Wayne Cancer Institute (JWCI) at Providence Saint John's Health~     Center (PSJHC) are trying to examine whether acupuncture reduces joint pain in patients being~     treated with aromatase inhibitor (AI) therapy for breast cancer and whether the reduction in~     pain happens by lowering inflammation.~   "
77803|NCT02548624|"~     The primary objective of the study is to examine the effectiveness of the Zephyr BioPatch in~     measuring position changes of a non-patient subject in a lab setting and to examine the~     effectiveness of the Zephyr BioPatch in measuring position changes of hospitalized patients.~   "
77804|NCT02548611|"~     Use of high loading doses of clopidogrel (antiplatelet drug) just before coronary~     interventions is associated with improved outcomes after coronary stenting. However the onset~     of platelet inhibition after clopidogrel loading takes 2 to 4 hours and its action if very~     variable. A way to overcome this limitation is loading with a more potent antiplatelet drug~     such as prasugrel. Therefore in the current study the investigators want to compare loading~     with 60 mg prasugrel (potent antiplatelet drug) and loading with clopidogrel (standard drug)~     in patients undergoing elective coronary intervention.~   "
77805|NCT02548598|"~     This is a cross-sectional, non-interventional study, consisting of three study arms, (1) Full~     Characterization (AIMS-Full), (2) Surgery Arm (AIMS-OR), and (3) Mucus Collection (AIMS-M).~     Participants will be recruited and enrolled in either AIMS-Full or AIMS-OR (based on~     participant availability). Participants who complete the initial characterization study~     (either AIMS-Full or AIMS-OR), may also go on to participate in the AIMS-M arm, which focuses~     mainly on sample collection. Participants who choose not to participate in either~     characterization arm are able to enroll directly into AIMS-M for sample collection only.~   "
77806|NCT02548585|"~     A Phase 1/2, multiple dose study with 6 cohorts of ascending doses designed to evaluate the~     efficacy, safety and pharmacokinetics (PK) of MEDI0382 in patients with Type 2 Diabetes~     Mellitus (T2DM).~   "
77807|NCT02548572|"~     Several studies have shown that TES in RP patients may help to slow the progressive~     deterioration of this degenerative disease. The end point of this clinical trial is to slow~     or stop disease progression with weekly treatment using TES for 1 year.~   "
77808|NCT02548559|"~     This study evaluates the effects of cannabidiol (CBD) for the treatment of anxiety in adults~     certified for medical marijuana. Participants will use a sublingual (under-the-tongue)~     tincture of whole plant derived CBD three times daily for four weeks in addition to their~     normal treatment regimen. Participants' clinical state will be assessed weekly during the~     treatment period. In addition, cognitive function and measures of quality of life, sleep, and~     general health will be assessed at baseline and the post-treatment final visit.~   "
77809|NCT02548546|"~     The primary aim of this study is to establish the practicality of using two novel imaging~     modalities for the assessment of biomechanical properties of the aorta.~   "
77810|NCT02548533|"~     The purpose of this study is to assess the efficacy of skin anesthesia using fractional laser~     assisted delivery of articaine hydrochloride 40 mg/ml and epinephrine 10 µg/ml solution~     (AHES) compared to standard anesthesia with topical eutectic mixture of lidocaine 25 mg/g and~     prilocaine 25 mg/g cream (EMLA cream) prior to ablative fractional laser treatment of acne~     scars and traumatic scars.~   "
77811|NCT02548520|"~     In this study the investigators wanted to assess vitamin D status and possible consequences~     of low plasma 25-hydroxyvitamin D levels in a population of healthy mothers and their~     infants, in the community of Aarhus, Denmark.~   "
77812|NCT02548507|"~     Background :~      Nocturnal leg cramps (NLC) are defined as painful involuntary contractions of the lower limbs~     occurring during prolonged periods of rest, typically during the night. They may cause severe~     pain and sleep disturbance, and are particularly common among older adults, though they can~     occur in all decades of life. They are frequently unreported to physicians. To the~     investigators' knowledge, no epidemiological studies have been conducted in Switzerland, but~     in a general population survey carried out in the UK (n=233), the overall prevalence of NLC~     was 37% and the disorder was more prevalent in older subjects (>80 years old: 54%). Of those~     who experienced NLC, 40% had cramps three or more times per week and 6% nightly. Another~     study performed in older US veterans (n=515) showed that 56% suffered from NLC.~      The precise cause of these cramps is unclear. Most NLC occurring in adults appear to be~     idiopathic, but potential contributing factors include low levels of certain minerals,~     extracellular fluid volume depletion and prolonged sitting or inappropriate leg position~     during sedentary activity.~      Research question :~      What are the prevalence and the main features of NLC in patients consulting primary care~     physicians (PCPs) in Geneva, and how do PCPs treat this affection?~      Primary objective :~      To compute the prevalence of NLC in patients consulting PCPs in Geneva, explore its main~     features (number, duration, severity and sleep disturbance) and assess how PCPs treat this~     affection.~      Study design :~      Prospective observational study using questionnaire and daily log completed by patients.~   "
77813|NCT02548494|"~     The management goals of diabetic ketoacidosis (DKA) in the pediatric type 1 diabetes (T1DM)~     population are fluid and electrolyte repletion, insulin administration, and correction of~     acidosis in order to stabilize the patient. Traditionally, a rapid-acting insulin IV infusion~     is begun immediately and continued until the acidosis is corrected and hyperglycemia~     normalized. Once the acidosis is corrected, patients are able to be transitioned to a~     subcutaneous insulin regimen.~      The role that a subcutaneous long-acting insulin such as glargine has in the acute treatment~     of DKA has not been extensively studied. While giving glargine during the treatment of DKA is~     becoming more common place, few studies have examined the potential risks and benefits of its~     use. This study will investigate the effects of early administration of glargine during DKA~     in patients with newly diagnosed TIDM.~      The design of this study is a prospective, double-blind study of children ages 2-21 who are~     admitted to the hospital in DKA with a diagnosis of T1DM. The control group will receive all~     traditional methods of treatment for DKA, including a placebo subcutaneous injection. The~     study group will receive the same treatment, but will be supplemented with a subcutaneous~     glargine injection.~   "
77814|NCT02548481|"~     Every year in France, from 100 000 to 145 000 people are affected by a stroke. 75% patients~     survived with aftereffects, in particular aphasic disorders.~      A sketch of a new tool called BESTA aiming to a rapid handover to the acute phase post stroke~     had been worked out. After a meeting, 13 multidisciplinary experts have discussed, adjusted~     and a new complete tool (BESTA) had been created in order to evaluate the different states of~     aphasia.~      The goal of this study is the validation and the standardization of this new BESTA tool.~   "
77827|NCT02548299|"~     This study is a multi-dimensional therapeutic lifestyle program that offers cooking and~     nutrition education as well as email-based health coaching to diabetic patients in an~     underserved Cleveland community. This is an innovative project as it is one of the first~     focused efforts within this community to improve diabetes control and prevent diabetes~     progression through cooking and nutrition as well as to systematically measure both clinical~     and behavioral outcomes.~   "
77815|NCT02548468|"~     This phase I trial studies the side effects and the best dose of donor lymphocyte infusion~     when given together with reduced intensity conditioning regimen before partially matched~     donor stem cell transplant in treating patients with stage IIB-IV mycosis fungoides or Sezary~     syndrome. Giving chemotherapy and low-dose total-body irradiation followed by high-dose~     cyclophosphamide before a donor peripheral blood stem cell transplant helps stop the growth~     of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer~     cells. Sometimes the transplanted cells from a donor can make an immune response against the~     body's normal cells (called graft-versus-host disease). Removing the T-cells from the donor~     cells and giving them before transplant may stop this from happening. Additionally, giving~     tacrolimus and mycophenolate mofetil before and after transplant may also stop this from~     happening.~   "
77816|NCT02548455|"~     The primary intent of this study is to assess the safety of the model 1457Q Quartet LV lead~     at 3 months in a patient population indicated for cardiac resynchronization therapy.~   "
77817|NCT02548442|"~     Development and Clinical Evaluation of the Stemina Metabolic Biomarker-Based Test to Diagnose~     Autism Spectrum Disorder in Early Childhood.~   "
77818|NCT02548416|"~     Atelectasis is common during and after general anaesthesia and a number of interventions have~     been suggested in order to prevent their formation. The use of Positive End Expiratory~     Pressure (PEEP) during general anaesthesia has in recent years been questioned.~      The investigators hypothesize that the use of PEEP as a single intervention improves~     oxygenation and prevents atelectasis as investigated by computed tomography compared to a~     control group with zero PEEP.~   "
77819|NCT02548403|"~     Optimal bowel preparation is essential for colonoscopy efficacy and safety. Mucosal~     visualization during colonoscopy is often limited by residual stool, bubbles, bile,~     intraluminal fluid, and debris, which increase the risk of missing flat adenomas or other~     small lesions.Therefore, intestinal preparation is necessary to remove residual materials~     prior to endoscopy.~      A combined agent, low-dose PEG with ascorbic acid (PEG-Asc), is one low-volume solution~     commonly used in Korea (Coolprep®; TaeJoon Pharmaceuticals, Seoul, Korea). However,~     practitioners have noted an increased incidence of bubble formation with this preparation~     method.~      To the investigators knowledge, no previous study has assessed colon preparation in patients~     administered simethicone.~      The purpose of this study was to compare the quality of bowel preparation and compliance~     between PEG-Asc and PEG-Asc with simethicone. The effectiveness of adding simethicone as an~     antifoaming agent to improve bowel cleansing for colonoscopy was evaluated in terms of bowel~     preparation scale and bubble score, and the compliance of both patients and endoscopists was~     also investigated using a questionnaire.~   "
77820|NCT02548390|"~     This is an open-label, Phase I/Ib, dose escalation study of intravenous RXDX-107 administered~     to subjects with advanced solid tumors. The study is designed to explore the safety, maximum~     tolerated dose (MTD), pharmacokinetics, pharmacodynamics, and preliminary clinical activity~     of RXDX-107 and to define a recommended Phase 2 dose (RP2D)~   "
77821|NCT02548377|"~     The purpose of the trial is to investigate, if remote ischemic preconditioning reduces the~     risk of complications in patients undergoing resection of head and neck cancer and immediate~     reconstruction with autologous free tissue transfer.~      Remote ischemic preconditioning is a treatment, which is carried out by inducing brief~     episodes of upper arm occlusion using an inflatable tourniquet.~      Blood samples will be taken during the operation and postoperatively to evaluate the effects~     of remote ischemic preconditioning. These blood samples will be analyzed for clotting~     properties and markers of inflammation.~      Furthermore, effects on the blood supply of the transferred tissue flap will be measured by~     infrared thermography.~      Effects on surgical complication rates will be obtained by clinical follow-up and patient~     chart review.~   "
77822|NCT02548364|"~     To study the effect of calcifediol on left ventricular remodeling, mineral metabolism, plasma~     levels of several prognostic biomarkers and on endothelial function after an anterior~     myocardial infarction.~   "
77823|NCT02548351|"~     The primary objectives of this study are to evaluate the effect of Obeticholic Acid treatment~     compared to placebo on 1) histological improvement and 2) liver-related clinical outcomes in~     patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.~   "
77824|NCT02548338|"~     The investigators are selecting sixty (60) with breast cancer diagnoses where the surgical~     treatment is indicated.Furthermore the investigators divided in two groups : 1) surgical~     treatment using regular electric scalpel ; 2) surgical treatment using argon plasma~     coagulation scalpel. Our primary goal is to measure the bleeding during the surgery using the~     weight of the surgical tissues used. Secondary we'll evaluate the immediate post operative~     outcomes, like infection, hematomas and seromas. All these variables will be evaluated by a~     doctor using our standard clinical record and it will be measured using reliable parameters,~     for exemple: if the investigators clinically detect a hematoma then we'll perform an~     ultrasound to take the real extension; if the investigators clinically pick an infection~     we'll measure the extension of the hiperemia; and if the investigators clinically pick a~     seroma we'll drain and quantify it. Secondary the investigators going to evaluate and measure~     (centimeters) the terminal damage caused on the surgical specimens (samples) using the~     microscope.~   "
77825|NCT02548325|"~     The aim of this study is to evaluate the prevalence of hepatitis B in Vallés Occidental.~     Also, describe the stage of the disease, and whether if they are under medical treatment or~     not.~   "
77826|NCT02548312|"~     Financial ties with industry are common among doctors, academics and institutions. This trial~     aims to investigate the influence of different types of industry-linked activities on~     readers' perceptions of clinical reviews. Two clinical reviews have been selected on medical~     topics and study participants (practicing doctors) will be sent one review each. The reviews~     will be identical except for the inclusion of one of four different permutations of competing~     interest statements. Participants will be asked to rate the one review they are sent based on~     the study outcomes (confidence, interest, importance and likeliness to change practice). The~     study focus is on educational articles as these are intended to guide patient care and convey~     the authors' interpretation of selected data.~   "
77828|NCT02548286|"~     The purpose of this study is to compare the safety and pharmacokinetics of CKD-330~     (fixed-dose combination of Candesartan Cilexetil 8 mg and Amlodipine 5 mg) with~     coadministration of the two separate drugs in healthy male volunteers.~   "
77830|NCT02548260|"~     Proximal interphalangeal joint injuries of the fingers may be treated in various ways and no~     treatment has been shown to be superior. The investigators wish to study the effectiveness of~     syndactyly versus digital splint when comparing joint mobility. The investigators also wish~     to study the effectiveness of finger compression in reducing edema and therefore allowing a~     greater arc of motion.~   "
77831|NCT02548247|"~     Investigation of the effects of a four week daily consumption of Orafti® Inulin on bowel~     motor function in subjects with constipation.~   "
77832|NCT02548234|"~     The study purpose is to compare the efficacy of mirror therapy and bilateral arm training on~     movement strategies of the affected upper extremity and functional outcome in chronic stroke~     patients.~   "
77833|NCT02548221|"~     The physiologic basis for relief from dyspnea after therapeutic thoracentesis remains poorly~     understood. Improvement of the heart and lung function may contribute to the dyspnea relief.~     But there is no data support this phenomenon. Transthoracic echocardiogram (TTE) is a~     non-invasive viewing of the heart, which can quickly assess the heart function through~     real-time images. The investigators performed thoracentesis on patients with large-volume~     pleural effusions, and utilized TTE to access the change of heart and lung function before~     and after this medical procedure.~   "
77834|NCT02548208|"~     The study is a single-center, double blinded, randomized controlled trial aimed to~     investigate the effects of focused extracorporeal shockwave therapy (fESWT) on Delayed Onset~     Muscle Soreness (DOMS) of the non-dominant biceps brachialis muscle in healthy voluntary~     adults.~   "
77835|NCT02548195|"~     To evaluate of adjuvant therapy using oxaliplatin and gemcitabine (GEMOX regimen) versus~     capecitabine alone chemotherapy in patients who underwent curative surgery for intrahepatic~     cholangiocarcinoma (ICC) -- a randomized control study.~   "
77836|NCT02548182|"~     The investigators are planning to conduct a pilot RCT of young obese population to evaluate~     the effect of smartcare with or without financial incentives for 12 weeks. Participants will~     be randomly assigned to a three-arm of control, smartcare, and smartcare plus financial~     incentives group.~   "
77837|NCT02548169|"~     The primary objective is to confirm clinical safety and feasibility of combining the~     antigen-loaded Dendritic Cell (DC) vaccine with chemotherapy including folinic acid,~     oxaliplatin, irinotecan and 5-Fluorouracil (5FU) (FOLFIRINOX) and nab-paclitaxel/gemcitabine~     in patients with pancreatic cancer.~      The secondary objectives of this trial are to determine preliminary clinical efficacy based~     on response rates, overall survival and progression free survival compared with historic~     control, and surgical conversion rate as defined as percent of locally advanced~     (unresectable) patients achieving resectability within 6 months of treatment initiation.~     Also, to identify vaccine immunogenicity by measuring acquired, T cell-mediated immune~     activating events post-vaccination and to correlate clinical response with acquired immune~     responses.~   "
77838|NCT02548156|"~     The aim of this study is to assess the impact of formulation differences on fluoride~     retention clearance with US levels of fluoride (1150 ppm of fluoride) by evaluating and~     comparing between treatments the concentrations of fluoride and calcium ions in saliva over~     60 minutes after a single brushing with US marketed fluoridated dentifrices and following a~     dietary acid challenge post 60 minutes of brushing with study treatment.~   "
77839|NCT02548143|"~     The purpose of this study, PerSept 3, is to evaluate LR769 for the prevention of excessive~     bleeding and achievement of hemostasis in congenital hemophilia A or B patients who have~     inhibitors to Factor VIII or Factor IX , are aged 6 months to 75 years, inclusive; and who~     are undergoing elective surgical or other invasive procedures. Administration of LR769 will~     be performed just prior to surgery/procedure and will be repeated during and after the~     surgery/procedure to achieve and maintain adequate hemostasis as determined by the~     investigator's judgment.~   "
77840|NCT02548130|"~     The goal of this observational study was to evaluate the impact of the adoption of the MELD~     system to prioritize patients on the waiting list for OLT on survival for 700 consecutive~     liver transplantations. Survival was evaluated on the waiting list, one month, and one year~     after the transplantation. Another goal was to look at blood losses and transfusion~     requirement after the adoption of the MELD score. The hypothesis was the MELD system will~     ameliorate the survival rate on the waiting, but the post-OLT will be worse. Blood losses and~     transfusions could be worse with the MELD system.~   "
77841|NCT02548117|"~     Hypogonadism (low testosterone) is becoming an increasingly recognized problem that affects~     numerous men in the United States. Symptoms may be always feeling tired, lower sex drive, and~     loss of muscle mass. Treatment typically involves testosterone in either injections or a~     topical gel form.~      However, administration of testosterone is not without side effects of its own. Testosterone~     supplementation therapy is known to cause a variety of side effects including high blood~     pressure and high lipids (fats) and an increased proportion of red blood cells. Side effects~     of increased red blood cells can include an increased risk of developing a blood clot.~      The increase in the red blood cells is related to dihydrotestosterone (DHT - a male sex~     hormone) activity. It is normal for the testosterone to become DHT. DHT has various effects~     on the body including growth of the prostate gland, baldness, and others and DHT levels have~     been linked to elevated red blood cell counts in men on testosterone.~      Finasteride is an FDA approved medication used in the treatment of benign prostatic~     hypertrophy (BPH) in men with enlarged prostate to improve symptoms and to reduce the risk of~     the need for surgery. Finasteride may prevent elevations in or reduce elevated red blood cell~     levels in men on testosterone.~   "
77857|NCT02547909|"~     Endometriosis is defined as the presence of endometrial glands and stroma outside of the~     uterus.Endometriosis affects 5%-15% of women in the reproductive age. Deep endometriosis is~     mostly defined as a single endometrial nodule, located in the vesico-uterine fold or close to~     the distal 20 cm of the large bowel. Current guidelines recommends that laparoscopy with~     histology should be done to diagnose endometriosis. Probe-based confocal laser endomicroscopy~     (pCLE) has been used as a GI tract endoscopy additive tool in recent years, providing in-vivo~     cellular-level imaging, a concept known as optical biopsy. considering the rectal bleeding~     that occurs in patients suffering from bowel endometriosis, usually with a normal mucosa seen~     at standard endoscopy (personal data), we hypothesized that there might be histological~     architectural changes in the vessels or the mucosa/sub mucosa in bowel endometriosis.~   "
77842|NCT02548104|"~     Recently, more distal approach to femoral nerve branches (saphenous) in the adductor canal in~     the medial compartment of the thigh have shown to provide comparable anesthesia and analgesia~     without quadriceps muscle weakness than traditional femoral nerve blocks (FNB) after total~     knee arthroplasty (TKA). Adductor canal block (ACB) has the unique advantage of providing~     localized analgesia to the peripatellar and intra-articular aspects of the knee joint without~     reducing the patient's ability to perform a straight leg raise. However, it does not~     adequately address the incisional pain component on the anterior surface of the knee~     innervated by anterior femoral cutaneous nerve. This pain may be improved by addition of the~     anterior femoral block (AFB). Additionally, the ACB does not provide analgesia to the~     posterior aspect of the knee, which is commonly moderate to severe after surgery. This pain~     may be decreased by addition of the genicular block, also known as the iPACK block~     (interspace between the popliteal artery and the capsule of the knee). There is no study that~     has evaluated the potentially analgesic benefits of the AFB or the iPACK block combined with~     ACB after TKA. Therefore, the investigators designed this randomized, prospective, and~     double-blinded study to assess our hypothesis that the addition of the AFB and/or iPACK block~     to the ACB will improve analgesic effects, decrease pain scores, deceased opioid requirement,~     and as well as facilitate early recovery and improve patient satisfaction with pain~     management in patient after TKA.~   "
77843|NCT02548091|"~     The purpose of this study is to determine whether Non Invasive Ventilation are effective in~     prevention of reperfusion pulmonary edema after pulmonary artery angioplasty. Our hypothesis~     is that administration of Non Invasive Ventilation during the procedure and systematically in~     post procedure period is a protective factor against the development and severity of~     reperfusion pulmonary edema.~   "
77844|NCT02548078|"~     The purpose of this study is to assess the safety and reactogenicity of a single IM dose of~     the GSK3390107A (ChAd3 EBO-Z) vaccine, overall and in children aged 1 to 5, 6 to 12, and 13~     to 17 years, separately.~      Considering the risk of exposure to Ebola and the potential (based on animal data) for the~     investigational GSK3390107A (ChAd3-EBO-Z) vaccine to afford at least partial protection, all~     children in the study will receive the investigational GSK3390107A (ChAd3 EBO-Z) vaccine. The~     children in the Group GSK3390107A+Nimenrix will receive the investigational GSK3390107A~     (ChAd3-EBO-Z) vaccine at Day 0 of the study, whereas the children in the Group~     Nimenrix+GSK3390107A will receive Nimenrix at Day 0 (as a control). At Month 6, the children~     in the Group Nimenrix+GSK3390107A will receive the investigational GSK3390107A (ChAd3-EBO-Z)~     vaccine (provided that no safety concerns are raised), whereas the children in the Group~     GSK3390107A+Nimenrix will receive Nimenrix.~   "
77845|NCT02548065|"~     The present randomized, controlled double blind trial aims to evaluate the efficacy and~     tolerability of balneotherapy with mineral water named Debole of Vetriolo in 100 patients~     with primary Fibromyalgia Syndrome (FS).~   "
77846|NCT02548052|"~     GSK2981278 is a highly potent and selective inverse agonist of retinoic acid receptor-related~     orphan receptor gamma (ROR gamma) that is under development for topical treatment of plaque~     type psoriasis suitable for topical therapy.~      This is the first study to administer GSK2981278 to subjects with psoriasis. This~     proof-of-concept study will evaluate the safety, tolerability and initial efficacy of a range~     of concentrations of GSK2981278 ointment with repeated topical applications in adult subjects~     with psoriasis. Results of this study will provide first clinical information on the drug's~     safety and efficacy in psoriasis and inform the selection of concentration of GSK2981278~     ointment to be evaluated in subsequent clinical studies.~      This is a Phase 1, single center, test field-randomized, vehicle- and positive- controlled,~     subject- and evaluator-blind study. All subjects will receive all 6 treatments on 6 test~     fields, for intra-individual treatment comparison. For every subject, the manner of~     assignment of each treatment to a particular test field will be according to a randomization~     scheme. Thus, the test fields within each subject, and not the subjects themselves, will be~     randomized.~      The study will consist of screening, followed by a treatment period of 19 days, and a~     follow-up visit at Day 27 (+/-2) for subjects who will consent for biopsy. During the~     treatment period, subjects will receive all of these treatments: GSK2981278 ointment 0.03%~     weight by weight [w/w], 0.1% w/w, 0.8% w/w, 4% w/w, GSK2981278 vehicle, and betamethasone~     valerate 0.1% cream. The test fields on which these treatments will be applied will be~     identified on stable plaque(s) on the upper extremities, thighs and/or trunk. A blinded~     evaluator (an investigator or designee) will perform the measurements and assessments whereas~     an unblinded study staff member (not an evaluator) will perform biopsy collection.~   "
77847|NCT02548039|"~     The purpose of this study is to match the genetic component and clinical attributes of~     anovulatory patients with response to clomiphene treatment.~      By improving our understanding on patient-specific clomiphene response will allow~     optimization of treatment, reduction of side-effects and shorten the time-to-pregnancy.~   "
77848|NCT02548026|"~     The purpose of this study was to determine the effects of low vs. high eating frequency (EF)~     on biomarkers of health and subjective appetite.~   "
77849|NCT02548013|"~     This study is to compare the maternal and neonatal outcomes in the patients with PPROM who~     are managed at home versus those managed at hospital, half the patients will be managed at~     home and the other half will be managed inpatient.~   "
77850|NCT02548000|"~     This study aims to verify the effects of resistance training on neuromuscular, vascular and~     functional adaptations of elderly diabetics type 2. Half of participants will be the~     intervention group that will perform resistance training, while the other half will be the~     control group that will perform stretching sessions.~   "
77851|NCT02547987|"~     The purpose of this study is to determine whether the combination of docetaxel and~     carboplatin is an effective treatment for patients with triple negative breast cancer.~   "
77852|NCT02547974|"~     The purpose of this study is to assess the safety, reactogenicity and immunogenicity of the~     investigational GSK Biologicals' GSK3277511A vaccine in adults~   "
77853|NCT02547961|"~     The purpose of this study is to evaluate the safety and efficacy of HER2-CAR-T cell Infusion~     for advanced HER2 positive breast cancer.~   "
77854|NCT02547948|"~     The purpose of this study is to evaluate the safety and efficacy of CD19-targeting CAR T~     Cells infusion for B Cell Lymphoma.~   "
77855|NCT02547935|"~     The purpose of this clinical research study is to determine whether dapagliflozin alone or in~     combination with saxagliptin can decrease albuminuria and improve glycemic control in~     patients with Type 2 diabetes, albuminuria and renal impairment (CKD). The study is planned~     to randomize a total of 450 patients (150 patients per treatment arm).~   "
77856|NCT02547922|"~     The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment~     regimen of two doses of anifrolumab versus placebo in adult subjects with active~     proliferative lupus nephritis (LN).~   "
78651|NCT02537431|"~     The primary objective of this study is to establish the effect of KRN23 treatment on~     improvement in XLH-associated osteomalacia as determined by osteoid volume (osteoid~     volume/bone volume, OV/BV).~   "
77858|NCT02547896|"~     It will be evaluated the clinical efficacy of Diclofenac 50mg (NSAID) compared to its~     association with Codeine 50mg (opioid) administered in 50 patients requiring extraction of~     two third molars. After assessing the research parameters, a comparative data analysis, along~     with the proper application of statistical tests, will provide the basis for an evaluation of~     both efficiency medications used.~   "
77859|NCT02547883|"~     In patients ≥ 75 years, there is no evidence that statins in primary prevention are~     associated with a decreased mortality and recent US recommendations consider statins in~     people only between 40 and 75 years. Moreover, statins are associated with numerous side~     effects impacting quality of life of those people and represent a high cost for the French~     healthcare system.~      The aim of the present study is to evaluate cost/effectiveness ratio, in real life, of statin~     cessation in people ≥ 75 years treated in primary prevention.~   "
77860|NCT02547870|"~     The purpose of this study is to compare the single‐dose pharmacokinetics of rilpivirine (RPV)~     after intramuscular (IM) injection of rilpivirine long‐acting parenteral formulation (RPV‐LA)~     and 'aged' RPV‐LA, in healthy adult participants.~   "
77861|NCT02547857|"~     Pelvic ultrasound is frequently performed in the ED in non-pregnant women to assess for~     ovarian pathology, though its use has not been described in the medical literature. This~     observational study aims to describe its use in clinical ED practice.~   "
77862|NCT02547844|"~     To compare the lipidomic profile in patients with HIV-1 with viral suppression changing~     efavirenz + emtricitabine + tenofovir (Atripla) to rilpivirine + emtricitabine + tenofovir~     (Eviplera®) versus a group of patients that continue with Atripla®.~   "
77863|NCT02547831|"~     This is a prospective, multicenter observational study under the umbrella of the ISG (Italian~     Sarcoma Group) evaluating local progression-free survival at 3 years of patients affected by~     extra-abdominal primary fibromatosis managed with front-line conservative approach and~     treated only in case of demonstrated progressive disease.~      All patients included will be placed on wait and see approach and then shifted to treatment~     in case of documented radiological progressive disease.~      For patient primarily evaluated for suspected desmoid tumor, a core-needle biopsy (eventually~     under CT/ultrasound guide) will be obtained for histological diagnosis and mutational~     analysis of CTNNB1 exon 3 (gene encoding Beta-catenin). If incisional biopsy or surgical~     procedure has done elsewhere, samples will be requested for histological confirmation and~     mutational analysis (centralization at the investigators Institution).~      In case of progression at 3 months, defined as tumor growth documented radiologically (by~     contrast enhanced MRI) by Response Evaluation Criteria in Solid Tumors (RECIST), administered~     treatments will be proposed and then registered in the clinical database.The choice of the~     treatment and eventually the possibility of continuation of  surveillance only will be at~     the discretion of Institution's Multidisciplinary Sarcoma Committee or as part of clinical~     trials with the consent of patient.~   "
77864|NCT02547818|"~     This is a global Phase III, randomized, double-blinded, placebo-controlled study for subjects~     with evidence of early AD. The protocol is designed to determine whether ALZT-OP1 combination~     treatment (ALZT-OP1a + ALZT-OP1b) will slow down, arrests, or reverse cognitive and~     functional decline, in subjects with evidence of early stage Alzheimer's disease (AD).~   "
77865|NCT02547805|"~     Evaluate the safety, tolerability, and efficacy of 28 days of treatment with ALLN-177 for~     reducing urinary oxalate excretion in patients with secondary hyperoxaluria and kidney~     stones.~   "
77866|NCT02547792|"~     This is a phase 1, single-center, placeb-controlled, double-blind study. The purpose of this~     study is to determine the safety and immunogenicity of an oral vaccine tablet to prevent~     seasonal influenza B tested at two dose levels (low and high dose). The study will enroll 27~     subjects in the low dose cohorts (3 sentinel open label subjects followed by 24 subjects~     (randomized 2:1 to vaccine vs placebo, respectively). Subsequently, 27 subjects will be~     enrolled in the high dose cohort in a similar manner as to the low dose cohort. Safety and~     immunogenicity will be evaluated at Day 28. Long term safety follow-up will be evaluated~     through 1 year post vaccination.~   "
77867|NCT02547779|"~     The administration of intravenous fluids is ubiquitous in the care of the critically ill.~     Commonly available isotonic crystalloid solutions contain a broad spectrum electrolyte~     compositions including a range chloride concentrations. Recent studies have associated~     solutions with supraphysiologic chloride content with hyperchloremia, metabolic acidosis and~     renal vasoconstriction, acute kidney injury and renal replacement therapy, and increased~     mortality but no large, randomized-controlled trials have been conducted. SMART-SURG will be~     a large, cluster-randomized, multiple-crossover trial enrolling critically ill patients from~     the non-medical ICUs at Vanderbilt University from October 2015 until April 2017. The primary~     endpoint will be the incidence of Major Adverse Kidney Events in 30 days after enrollment~     (MAKE30 is the composite of death, new renal replacement, or persistent renal dysfunction at~     discharge).~   "
77868|NCT02547766|"~     Heart failure remains a major cause of morbidity and mortality. Many patients with heart~     failure receive support from a left ventricular assist device (LVAD) at some point in the~     course of their disease. Some of these LVAD patients experience a durable recovery after~     ventricular unloading with an LVAD, which may be associated with inhibition of inflammatory~     cytokines. This small pilot study aims to determine the biologic and clinical efficacy of an~     interleukin-1 receptor antagonist (Anakinra) at inducing myocardial recovery in patients~     supported with left ventricular assist devices.~   "
77884|NCT02547558|"~     To evaluate the pulmonary gas exchange response to a therapeutic high dose of inhaled~     indacaterol (300 mcg) in 20 outpatients with stable symptomatic COPD B and D GOLD 2011~     groups.~      Measurements on a single day before and after 60 and 120 minutes of indacaterol will include~     arterial PO2, PaCO2 and pH. AaPO2; SaO2 (by pulse oximetry) and oxygen and carbon dioxide in~     exhaled breath, systemic arterial pressure and heart rate will also be measured/calculated.~     Cardiac output will be directly measured by bio-impedance.~   "
77885|NCT02547545|"~     This is a cohort study. This study is to develop a predictive model of the side effects after~     chemotherapy, exploreing the potential risk factors of the side effects such as~     myelosuppression and chemotherapy realted vomit after the chemotherapy, so that it could help~     to alleviate patients' fear and anxiety about the side effects and the toxicity of~     chemotherapy. The potential risk factors were measured at baseline.~   "
77869|NCT02547753|"~     The literature is rich in studies that explore the type and frequency of oral abnormalities~     in transplanted recipients, but it is scarce in studies that provide scientific evidence on~     the risk of complications after invasive interventions on those patients. Within this~     context, the aim of our study is to evaluate the post-exodontic socket repair in kidney~     transplant recipients compared to a control group and see if some indicators in the~     population of transplanted people (complete blood count, cluster of differentiation 4 (CD4+)~     level, serum concentration of immunosuppressive drugs) can help to provide for the host~     response face a invasive procedures. Therefore, 30 kidney transplant recipients over six~     months and 30 healthy non immunosuppressed adults will be submitted to a maximum of 3 simple~     extractions, always by the same surgeon. Laboratory tests will be evaluated preoperatively~     and include: blood count and coagulation - for both groups - and urea, creatinine, CD4+ and~     cluster of differentiation 8 (CD8+) lymphocytes T and serum levels of immunosuppressive drug~     - only for the study group. Researchers will evaluate the patient in the postoperative 3, 7,~     21, 30 and 60 days. The presence, or absence, of post-exodontic complication and delay, or~     not, of socket repair will be the results of interest in this study and will be compared~     between the groups. The data will be evaluated by ANOVA, chi-square. Logistic regression~     analysis will be used to evaluate the influence of modifying factors such as smoking and~     presence of diabetes.~   "
77870|NCT02547740|"~     Glaucoma is the leading cause of irreversible blindness worldwide. This study aims to test a~     new method that may allow earlier diagnosis of glaucoma and better ways to monitor if it is~     getting worse. There is scientific evidence that the macula, the central part of the retina,~     can be involved in very early stages of glaucoma. Glaucomatous damage to the macula is very~     prevalent and is often missed using conventional clinical tests.~      Relatively little is known about progression of early glaucoma damage and its effects on the~     macula. This project investigates the nature of progressive damage to the macula and proposes~     new methods to improve accuracy to detect clinically significant progression.The study will~     evaluate the nature of damage to the macula's structures through OCT imaging and eye function~     via visual field tests.~   "
77871|NCT02547727|"~     A four-site intradermal rabies booster vaccination in HIV - infected patients who have ever~     received primary rabies vaccination could improve their immune response to this kind of~     vaccine.~   "
77872|NCT02547714|"~     The purpose of this study was to assess the efficacy and safety of secukinumab at Week 16~     based on psoriasis area and severity index (PASI) 75 in subjects who had inadequate response~     to cyclosporine A.~   "
77873|NCT02547701|"~     Pediatric patients affected by mild-to-moderate distal subungual onychomycosis (DSO) or~     affected by white superficial onychomycosis (WSO), due to dermatophytes, will be treated~     topically with P-3058 nail solution according to the appropriate treatment schedule.~   "
77874|NCT02547688|"~     Preliminary data show that high flow nasal air has been shown to reduce promote heat exchange~     due to evaporation of nasal mucus by the air flow resulting in heat loss. It is unclear~     whether unidirectional nasal airflow is well tolerated in healthy individuals. The central~     hypothesis of this proposal is that dry high flow nasal air will be sufficiently tolerated in~     healthy adults.~   "
77875|NCT02547675|"~     To provide access to rociletinib for patients with advanced or metastatic EGFR-mutant NSCLC~     who have been treated previously with EGFR directed therapy and have evidence of a T790M~     mutation (T790M+).~   "
77876|NCT02547662|"~     This phase II trial studies how well pomalidomide, ixazomib citrate, and dexamethasone work~     in treating patients with previously treated multiple myeloma or plasma cell leukemia.~     Biological therapies, such as pomalidomide and dexamethasone, use substances made from living~     organisms that may stimulate or suppress the immune system in different ways and stop cancer~     cells from growing. Ixazomib citrate may stop the growth of cancer cells by blocking some of~     the enzymes needed for cell growth. Giving pomalidomide, ixazomib citrate, and dexamethasone~     together may be more effective in treating multiple myeloma.~   "
77877|NCT02547649|"~     This study is designed to assess the effect of two different formulations of pneumococcal~     polysaccharide vaccine on safety and immunogenicity of V114 in healthy adults 50 years of age~     and older.~   "
77878|NCT02547636|"~     This study will evaluate the clinical specificity of the FilmArray NGDS Warrior Panel.~   "
77879|NCT02547623|"~     The study is a prospective, randomized, parallel-design, multicenter trial in patients ≥40~     years of age undergoing cataract surgery. Patients who meet all inclusion and no exclusion~     criteria will be randomized to 1 of 2 treatment groups~        -  A single 5 mcl anterior chamber injection of IBI 10090, 103.4 mcg/mcl dexamethasone,~          equivalent dexamethasone dose: 517 mcg at the conclusion of cataract surgery or;~        -  Prednisolone acetate ophthalmic suspension 1% eye drops administered 1 drop 4 times~          daily (QID) for 3 weeks Safety will be assessed by adverse events (AEs), slit lamp~          biomicroscopy, fundus examination, intraocular pressure (IOP), visual acuity, and~          specular microscopy endothelial cell count.~   "
77880|NCT02547610|"~     In this prospective study, we will recruit newly diagnosed esophageal cancer patients and~     perform MR/PET before and after chemoradiation therapy. In MR, new image sequences will be~     added to the conventional sequences, such as high resolution image, DWI, DCE, cine imaging.~   "
77881|NCT02547597|"~     There are few data regarding anti-anginal effects between beta-blockers with and without~     vasodilating property. Beta-blocker without vasodilating property is generally known to have~     unfavorable effects on glucose and lipid metabolism. Therefore, the investigators compared~     carvedilol and atenolol on anti-anginal and metabolic effects in patient with stable angina~     pectoris.~   "
77882|NCT02547584|"~     This pilot study aims to assess the impact of anxiety on the cardiac substrate remodeling in~     female patients with paroxysmal and persistent atrial fibrillation (AF).~   "
77883|NCT02547571|"~     The purpose of this study is to compare diet, type of bowel preparation and time of~     colonoscopy to determine if one method is better than the other and, if they are the same,~     identify the one which is the most convenient for the patients.~   "
77886|NCT02547532|"~     In the context of the increasing evidence of the pathogenetic role of microbiome in COPD, our~     aim is to determine the total and specific bacterial and viral load in sputa from patients~     with COPD due to AATD and to correlate these findings with cellular, biochemical and~     immunological characteristics of sputa. These quantitative data obtained from sputum will be~     analyzed in the context of the clinical and physiological parameters of the patients.~   "
77887|NCT02547519|"~     Type 1 diabetes (T1D) results from an autoimmune destruction of the insulin-producing beta~     cells within the pancreatic islets of Langerhans. This process is identified by circulating~     islet autoantibodies to beta cell antigens, and is mediated by a lack of immunological~     self-tolerance. Self-tolerance is achieved by T cell exposure to antigen in the thymus or~     periphery in a manner that deletes autoreactive effector T cells or induces regulatory T~     cells. Immunological tolerance can be achieved by administration of antigen under appropriate~     conditions. Administration of oral insulin in islet autoantibody-negative children who are~     genetically predisposed for T1D offers the potential for inducing immunological tolerance to~     beta cells and thereby protect against the development of islet autoimmunity and T1D.~   "
77888|NCT02547506|"~     The central goal of the proposed study is to generate essential pilot data necessary to~     support an established line of research leading to future extramural grant submissions. The~     aims of the current study are two-fold: 1) to compare cardiorespiratory fitness (CRF) and~     gait endurance across three groups of people: (1) individuals with Parkinson Disease (PD) who~     participate in boxing on a regular basis, (2) individuals with PD who participate in exercise~     other than boxing on a regular basis and (3) healthy controls of the same age who exercise on~     a regular basis and 2) to examine the relationship between CRF and motor symptoms of PD~     (bradykinesia, tremor and postural instability). Forty-five participants (15 for each group)~     who participate in exercise on a regular basis (at least 120 minutes of exercise per week for~     the past 3 months) will be recruited for this cross-sectional study. In a single testing~     session, participants will perform the following tests: (1) clinical performance measures and~     (2) a CRF assessment. A one-way ANOVA with appropriate post hoc tests will be used to examine~     differences in dependent variables across the three exercise groups. Relationships between~     CRF and clinical performance measures will be evaluated with Pearson's correlation~     coefficients.~   "
77889|NCT02547493|"~     Is pneumococcal conjugate vaccine (which induces a T-dependent humoral response) more~     efficient than pneumococcal polysaccharide vaccine (which induces a T-independent humoral~     response) in RA patients treated with abatacept, biotherapy targeting T-cells? The~     investigator propose to conduct a prospective, multicenter (11 centers), randomized,~     open-label study.~      The patients are going to be randomized in 2 groups: patients of the first group will be~     vaccinated with the polysaccharide pneumococcal vaccine (Pneumo23®/Pneumovax®) whereas~     patients of the second group will be vaccinated with conjugate pneumococcal vaccine~     (Prevenar13®).~   "
77890|NCT02547480|"~     The primary purpose of the study is to evaluate the pharmacokinetic profile, safety, and~     efficacy of LifePearl microspheres loaded with irinotecan in the treatment of liver~     predominant mCRC by chemoembolization.~   "
77891|NCT02547467|"~     The aim of this study is to assess the causes of death in patients with septic shock in~     French intensive care units. It is an epidemiologic and descriptive study .~   "
77892|NCT02547454|"~     This observational trial will examine the efficacy and safety of Mircera for renal anemia in~     participants with stage III-IV CKD in daily clinical practice. Mircera will be prescribed by~     treating physician and followed for approximately 36 months.~   "
77893|NCT02547441|"~     This study evaluates the safety and efficacy of once-daily application of CLS001 topical gel~     compared to vehicle gel in subjects with severe papulopustular rosacea.~   "
77894|NCT02547428|"~     This is a Phase IIb, randomized, double-blind, multicenter, 2-period, 2-treatment, crossover~     study to evaluate safety, efficacy, and duration of efficacy of CTN SR BID target total daily~     dose (TDD) 400 mg compared with placebo in adults with ADHD.~   "
77895|NCT02547415|"~     Medically unexplained chronic pain - without identifiable somatic origin - is yet an~     insufficiently known and explored field in children and adolescents by international clinical~     works. This research aims to characterize somatic, psychological, psychopathological and~     environmental (particularly attachment styles and family functioning) processes trough an~     observational study with three pain management centers.~      The study concerns children and adolescents from 7 to 17 years old, suffering of medically~     unexplained chronic pain and their parents who are referred to a pain center. It is composed~     of a somatic, psychological and family functioning assessment on the one hand and~     psychopathological and attachment evaluation on the other hand.~   "
77896|NCT02547402|"~     This is an exploratory study in a small, well controlled group of healthy subjects to explore~     the effect of CXA-10 on pravastatin and Vytorin® (combination of simvastatin and ezetimibe).~   "
77897|NCT02547389|"~     Improving medical compliance and health-related quality of life (HRQoL) among people with~     epilepsy (PWE) has become the focus of various treatment programs and behavioral~     interventions which continue to be challenging to both patients and health care~     professionals.~      In order to design an effective intervention on the management of epilepsy, the drug~     management of epilepsy by community health workers was evaluated.~   "
77898|NCT02547376|"~     Soft tissue sarcomas (STSs) are a rare group of cancers that can arise in any 'soft' tissue~     but commonly involve muscles, fat and nerves. Even following surgery and radiotherapy over~     50% of tumours will recur or spread and at present, there is no reliable test that allows~     doctors to predict in which patients this will occur.~      DNA that is not inside cells (cell-free or cfDNA) is present in very small quantities~     circulating in blood. In cancer patients some of this cfDNA comes from cancer cells. Analysis~     of cancer-derived cfDNA in patients with other cancers has shown that the quantity and~     characteristics of cfDNA changes with stage of disease and treatment. The researchers plan to~     investigate the abundance and persistence of cancer-derived cfDNA in STS patients at various~     stages of disease to investigate the potential role of these characteristics as biomarkers.~      Selection of the genetic characters to be tracked in the patients' cfDNA is an important~     consideration. An established hallmark of a cancer cell is the ability to undergo an~     unlimited number of cell divisions. In normal human cells protective structures on the ends~     of chromosomes called telomeres provide a mechanism to limit the number of times a healthy~     cell can divide. This limitation has to be overcome in cancer cells for a tumour to form.~     This occurs by the activation of one of two telomere maintenance mechanisms (TMM) - either an~     enzyme called Telomerase or a mechanism known as Alternative Lengthening of Telomeres (ALT).~     In many sarcomas the activation of either TMM is associated with genetic changes (mutations)~     in a small number of genes. As these mutations are not present in normal cells but mark an~     essential feature of cancer cells (and their capacity for unlimited cell division) they are~     likely to be reliable markers of the presence of STS cells.~      The investigators plan to develop sensitive, quantitative assays to detect TMM associated~     mutations in tumour derived cfDNA in the blood of patients with STSs, and track these~     mutations overtime. They will establish the amount of cancer-derived cfDNA in STS patients at~     the time of surgery, and persistence of this cfDNA during follow up visits following tumour~     resection and in the events of local tumour recurrence or spread (metastatic disease). Once~     these basic parameters are established analysis will be broadened to include other genes that~     are commonly mutated in STSs with a view of identifying other genetic characteristics that~     may also aid identification of patients at high risk of recurrence or spread. In summary all~     of the assays described above should facilitate better monitoring of patients with STS, and~     allow earlier treatment if STS recurs following surgery.~   "
77901|NCT02547337|"~     Type 1 diabetes is the major type of diabetes in the young. The pathophysiology still needs~     clarification in order to reach feasible means of preventing the disease. This study aims in~     defining the differences in pancreatic and intestinal blood flow between subjects with and~     without type 1 diabetes and validating the methodology to achieve this. Earlier animal~     studies have demonstrated changes in pancreatic islet blood flow using microspheres. The aim~     of this study is to test and validate a method for the assessment of islet perfusion in~     humans using molecular imaging. The investigators hypothesize that glucose-stimulated~     pancreatic perfusion is enhanced specifically in islets in healthy subjects and that this~     increase is mostly suppressed in subjects with type 1 diabetes.~      Positron emission tomography (PET) is a non-invasive imaging technique, which can be used to~     study flow and metabolism of different organs. Using radiowater ([15O]H2O) and PET, cellular~     perfusion can be measured directly and noninvasively. Recently, diffusion weighted magnetic~     resonance imaging (DWI) has also been applied as a complimentary method for the assessment to~     quantitate changes in pancreatic blood flow.~      In the study 10 healthy subjects and 10 subjects with type 1 diabetes will be imaged on two~     separate days. Pancreatic and intestinal perfusion are first measured with [15O]H2O and~     combined PET/magnetic resonance imaging before and 5 and 15 minutes after intravenous glucose~     infusion. On the second day, PET imaging is replaced by dynamic DWI conducted in the same~     time schedule and with intravenous glucose stimulation.~   "
77902|NCT02547324|"~     This is a prospective, single-blinded, randomized-controlled study comparing a new method~     (slump-sitting) with the conventional method (forward erect bending) of performing lumbar~     spine flexion X-rays.~   "
77903|NCT02547311|"~     Adolescents and emerging adults with type 1 diabetes (T1D) experience significant struggles~     with their diabetes management resulting in worsening diabetes health and increased~     complications. This population's declining well-being occurs during a time when they should~     be at their healthiest and enjoying multiple exciting life transitions. Their worsening~     diabetes management is complicated by the fact they are also learning how to become more~     independent from their family in preparation for eventually leaving home. Furthermore, the~     number of people under 20 years of age diagnosed with T1D has increased dramatically over the~     past 10 years giving rise to increased concern about providing care to this population.~      The Team Clinic Intervention is an innovative clinical care approach to address the medical~     and developmental needs of adolescents with T1D and their families. A group medical~     appointment format will be used for routine diabetes clinic visits in middle school and high~     school adolescents with T1D. Parents of these patients will be participating in their own~     group during these clinic visits. The Team Clinic model incorporates developmentally tailored~     peer support and novel learning tools, (e.g. games, physical activity, and/or interaction~     through Internet resources, e.g. blogs, forums) into the shared medical appointment design.~      The goal of Team Clinic Intervention is to improve medical and psychological outcomes in~     adolescents with T1D and their parents. The study will investigate, in a randomized~     controlled trial, the efficacy of a novel clinical care model that addresses the unique~     developmental strengths and weaknesses of the T1D adolescent population. The Team Clinic~     format streamlines clinical care delivery to this often-challenging patient population~     without placing additional burden on youth, families, or clinics because the intervention~     will be completed during routine diabetes care visits. Moreover, the Team Clinic approach~     maximizes the benefits of peer support by delivering care in a group format to address the~     sense of isolation that teens and families coping with chronic illness often feel.~      If successful, the Team Clinic Intervention will not only positively impact adolescents with~     T1D and their families, but it could be used as a model of care for other adolescents with~     chronic medical conditions struggling to remain involved and invested in their medical care.~     Team Clinics may be one approach to successfully engaging adolescents in their diabetes care~     prior to their transition away from home, which will help them remain invested and active in~     their medical care through adolescence and young adulthood.~   "
77904|NCT02547298|"~     Patients who are already scheduled to have a gynecologic, urologic or uro-gynecologic~     procedure involving cystoscopy (a lighted scope is used to look inside the bladder) under~     anesthesia will be approached to participate in the study. Once prospective study subjects~     are consented, they will be requested to complete the study questionnaires.~      At the time of the procedure, during the cystoscopy, patients will undergo hydrodistension~     (stretching the bladder with fluid). Photographic images of the bladder will be collected, to~     be later analyzed by examiners. Patients who have positive findings for interstitial cystitis~     during cystoscopy with hydrodistension, will be notified of the findings after the procedure.~      They will be asked to fill out an additional, previously completed questionnaire at the time~     of a follow-up visit, during a phone interview or responding to the questionnaire via a~     secure web site. These patients will be treated for interstitial cystitis by their primary~     providers as clinically indicated.~   "
77905|NCT02547285|"~     The proportion of people aged 60 and over in the French population has increased from 18% in~     1970 to over 22% in 2010.~      One major problem in the elderly is falling. About half of these falls cause a minor injury~     and between 5% and 25% will cause a more serious injury such as a fracture or a sprain~     (Alexander et al., 1992; Nevitt et al., 1991).~      It therefore seems essential to study the locomotion of seniors to limit the maximum risk of~     falling into a public health measure.~      Two factors may be involved:~        1. The first corresponds to factors related to natural aging topics~        2. The second is the environment that is a real problem for seniors (Rolling showers,~          presence of works ....) And especially the port of inappropriate footwear.~      Indeed, most of the elderly, institutionalized or not, do not wear proper shoes. It is this~     parameter that will be highlighted in our study.~   "
77906|NCT02547272|"~     Nasal colonization with S. aureus is a risk factor for infection with this bacterium. A~     methodologically well conducted study of S. aureus bacteremia showed that 80% of S. aureus~     bacteremia with are due to the strain isolated in the nasal level. However, as part of a~     study coordinated by the CHU of Saint-Etienne, less than 50% of infections in prosthetic~     orthopedic devices have been linked to nasal carriage . Outside of exogenous infections,~     intestinal colonization with S. aureus could be an alternative source of endogenous~     infections with the waning of orthopedic surgery. In the general population, considering that~     about one third of the subjects were colonized with S. aureus nasal level and 1 in 5 in the~     intestine However the proportion of exclusive intestinal porting is not well known .~      This study will analyze, among ICU patients, porting S. aureus nasal and rectal level. It~     will better clarify the relationship between nasal and rectal ports and the risk of~     developing an infection.~   "
77907|NCT02547259|"~     Currently there is uncertainty on how schizophrenic patients feel pain. Pain has several~     components including cognitive behavior which allow humans to perceive it as a negative~     emotion. It is difficult to say precisely what are the differences in cognitive processing~     between the emotional component of pain and painless another negative emotion (eg fear).~     However, pain and negative emotion have some neural networks together and there are many~     common ways between emotional processing (pain or negative) and storing information (limbic~     system).~   "
78164|NCT02543918|"~     The purpose of this study is to compare the body's immune response when vaccines are given~     alone versus when vaccines are given along with the study drug called ixekizumab. The~     vaccines protect against pneumonia and tetanus. This study will last about 6 weeks with~     follow-up at 12 weeks.~   "
77908|NCT02547246|"~     Bulimic patients suffering from binge eating or craving a pressing need to eat, with a~     sense of unease and anxiety, relieved by food intake. The phenomenon of craving bulimia may~     be considered appropriately by using paradigms developed in the framework of embodied~     cognition theories.~      In bulimic, a study with 20 bulimic patients proved an automatic attraction (unconscious) for~     food in these patients, as measured by reaction time.~      Moreover, a therapeutic explored in bulimia (particularly on reducing craving), is repeated~     transcranial magnetic stimulation (rTMS). Studies have shown that a single session of rTMS to~     the dorsolateral prefrontal cortex left (DLPFC) reduces significantly the food craving among~     bulimics, 24 hours after stimulation. But the therapeutic efficacy of TMS on bulimia to more~     than 24 hours has not yet been demonstrated, and the psycho-cognitive underlying mechanisms~     have not yet been explored.~   "
77909|NCT02547233|"~     The objective of the trial is to compare the short term efficacy of LEO 43204 gel with~     vehicle gel in AK on face or chest when applied topically once daily for 3 consecutive days~     as field treatment.~   "
77910|NCT02547220|"~     To evaluate the efficacy of Cinryze® given for the treatment of acute antibody-mediated~     rejection (of renal allograft) (AMR) in kidney transplant recipients as measured by the~     proportion of subjects with new or worsening transplant glomerulopathy (TG) at 6 months after~     treatment initiation.~   "
77911|NCT02547207|"~     The purpose of this study is to characterize left ventricular acute hemodynamic and~     electrical responses during cardiac resynchronization therapy (CRT) with different Multipoint~     Pacing (MPP) settings, and assess the relationship between electrical activation patterns and~     hemodynamic measurements during these pacing settings.~   "
77912|NCT02547194|"~     The health-related quality of life questionnaire EQ-5D has been collected in connection~     with several interventional and observational studies where the no-touch vein harvesting~     technique in CABG has been used. The results of the questionnaires will be compiled and~     reported in this study.~   "
77913|NCT02547181|"~     This Study is being done because the investigators would like to know if pain and hand~     function after having a boxer's fracture differs between being treated with supportive~     splinting or without splinting, but with behavioral modifications.~   "
77914|NCT02547168|"~     Lung resections for pulmonary malignancies offer the best chance of survival for patients,~     but these procedures carry a significant burden of post-operative morbidity and mortality.~     Patients are particularly at high risk for post-operative atrial fibrillation (a condition~     involving irregular heart rhythm). Atrial fibrillation with symptoms can increase the risk of~     stroke - a blockage in a major blood vessel in the brain, which can potentially result in a~     disability or even death. The objective of this study is to establish the feasibility of~     using ambulatory heart rate monitoring to determine the total incidence of atrial~     fibrillation in the peri-operative period before and after anatomic lung resection for~     malignancies. The study will also investigate the correlation between atrial fibrillation and~     rates of stroke and other adverse events, as well as serve to identify the patients that are~     at a higher risk of developing atrial fibrillation.~   "
77915|NCT02547155|"~     The purpose of the study is to compare the risk of being unable to urinate shortly after~     surgery, also called acute post-operative urinary retention (POUR) between spinal and general~     anesthesia in women who undergo outpatient pelvic organ prolapse with stress urinary~     incontinence surgery.~   "
77916|NCT02547142|"~     Palliative care physicians and nurses are trained to help reduce suffering and improve~     quality of life in patients under their care. Their services also include other components~     such as referral to dietitians, social workers and community resources, to assist patients in~     their homes. In addition to this, they may also administer interventions to make patients~     more comfortable, assisting them and their families in making important decisions and~     providing support, during that time.~      At present, palliative care is provided to esophageal cancer patients on an as-needed basis,~     through the referral of a heath care professional or the patient's request. This study aims~     to assess the impact of the integration of early palliative care combined with appropriate~     medical care in the metastatic esophageal cancer population, so that patients can benefit~     from these services at an earlier stage. It is hoped that this will improve quality of life,~     symptom management, depression and anxiety, as well as survival.~   "
77917|NCT02547129|"~     What is the difference in the outcomes of patients treated with an articulating antibiotic~     spacer versus a static articulating spacer in the setting of two stage exchange for infected~     total knee arthroplasty?~   "
77918|NCT02547116|"~     Methicillin-susceptible (MSSA) and Methicillin-resistant (MRSA) Staphylococcus aureus (SA)~     are two of the most important infectious pathogens in CF, with 69% of CF patients having lung~     infection with MSSA or MRSA in the last year. Wolter and co-workers recently demonstrated~     that a specific morphologic subtype of MSSA and MRSA, small-colony variant Staph aureus~     (SCV-SA), is associated with greater decline in lung function and worse clinical outcomes.~     SCV-SA is already recognized for its ability to contribute to persistent infection, likely~     due to SCV-SA's ability for intracellular growth, as well as its increased antibiotic~     resistance compared to normal-colony SA. To investigate the epidemiology and clinical~     significance of SCV-SA in CF, and explore the hypothesis that SCV-SA may require unique~     antibiotic treatment strategies to optimize clinical response, the investigators will perform~     the following:~        1. Characterize the epidemiology of SCV-SA infection in both an adult and pediatric CF~          population and investigate the clinical significance of SCV-SA infection in CF by~          comparing clinical characteristics and outcomes of CF patients with SCV-SA compared to~          those with to normal-colony MSSA/MRSA.~        2. Characterize the unique microbiologic characteristics of SCV-SA infection in CF by~          evaluating antibiotic susceptibility profiles and molecular characteristics of SCV-SA in~          a two large CF patient populations.~        3. Perform a 16-patient pilot study of a novel treatment for SCV-SA infection in CF,~          utilizing low dose rifampin in combination with standard anti-SA antibiotics.~      These investigations will delineate the role of SCV-SA as a pathogen in CF and provide~     guidance to optimize treatment strategies of MSSA/MRSA CF lung infection.~   "
78040|NCT02545530|"~     The majority of chronic hemodialysis patients need a combination of several antihypertensive~     drugs for adequate BP control. The primary objective of this study is to evaluate whether~     transdermal clonidine can improve blood pressure control or decrease oral antihypertensive~     agents type or dosage and the secondary objective is to observe incidence of adverse~     reactions of transdermal clonidine in chronic hemodialysis patients.~   "
77919|NCT02547103|"~     This pilot study aims to evaluate effectiveness, safety, and cost-utility of chlorhexidine~     gluconate (CHG)-soaked cloths compares to mupirocin ointment and exit site usual care (normal~     saline) with aseptic technique in prevention of PD-related infection. It is a pilot study,~     double-blind, stratified randomized controlled trial. Participants will be randomized to~     three arms mupirocin, usual care, or CHG-soaked cloths in a ratio of 1:1:1. They will be~     followed at 1,3,6,9, and 12 months or until PD-related infection, catheter removal, or death.~     The primary outcome is PD-related infection. Secondary outcomes are safety, adverse events~     related to treatments such as skin irritation, rash etc. Other outcomes are hospitalization~     due to PD-related infection, technical failure,change of modal of dialysis, adherence to~     medication, death due to PD-related infection. Costs include providers and patients expenses.~     Utility is assessed using the EuroQol (EQ), five-dimensional (5D), five-level (5L) version.~     The results of this study are anticipate nephrologists and health care professional involving~     to PD in decision making for a plan to prevent PD-related infection. In addition, the results~     will lead to clinical guideline development a prevention of PD-related infection.~   "
77920|NCT02547090|"~     Background:~      Posterior spinal fusion (PSF) in children with cerebral palsy (CP) carries a high risk of~     complications and mortality. Complication rates have been reported as high as 45%, and~     infection rates typically reported at 15%. Efforts to improve efficiency by reducing~     operative time and blood loss could decrease these risks. The purpose of this study is to~     investigate the impact of utilizing two attending surgeons on blood loss, operative time, and~     complications in this population.~      Methods:~      This is a prospective, matched cohort analysis with a consecutive series of patients with CP~     who underwent PSF, with two attending surgeons, in 2012. These are matched with a control~     group that had a single-surgeon team (operative dates 2008-2010), assisted by a resident, PA,~     or RN-FA. The groups are compared using paired Student T-tests and chi square tests~     (significance set a p<0.05).~   "
77921|NCT02547077|"~     The purpose of this study is to determine whether the use of 2-octylcyanoacrylate during~     repair of linear cutaneous surgery wounds improves scar cosmesis compared to wound closure~     with 5-0 fast absorbing gut.~   "
77922|NCT02547064|"~     The GlideScope® videolaryngoscope usually visualize glottis better than the conventional~     laryngoscope. Under the visualization of glottis by GlideScope®, the insertion of~     endotracheal tube, however, is challenging.~      The goal of this study was to determine which of two stylet (70° vs 90°) was better, as~     determined by time to intubation.~   "
77923|NCT02547051|"~     The purpose of this study is to see whether participants with persistent developmental~     disfluency who report fluctuational disfluency due to vocal cord tension on a day to day~     basis of can achieve a more normalized fluency by identifying dietary allergen responses and~     subsequently eliminating these dietary triggers from their daily consumption.~   "
77924|NCT02547038|"~     Reverse hybrid therapy achieves a higher eradication rate than bismuth quadruple therapy~     remained unanswered.~   "
77925|NCT02547025|"~     In this study, the investigators develop a personalized treatment according to culture-guided~     antibiotics plus high-dose proton-pump inhibitor and bismuth to treat refractory H pylori~     infection.~   "
77926|NCT02547012|"~     From the profiles of antibiotic susceptibility data following eradication therapy,~     tetracycline, amoxicillin and levofloxacin are all good candidates of antibiotics used in the~     rescue treatment.~   "
77927|NCT02546999|"~     In Norway, about 60% of all children with cerebral palsy (CP) are being treated with~     botulinum toxin A (BoNT-A) at 6 years of age, mainly in the legs. Despite this widespread use~     of the drug, the evidence for a positive effect on walking is insufficient. Moreover, large~     variation in effect is seen by clinicians. The main objective of the present study is to~     investigate whether injections with BoNT-A in the calf muscles make walking easier in~     children with spastic CP within 6 months, reflected by reduced energy cost during walking.~   "
77928|NCT02546986|"~     The purpose of this study is to determine whether the combination therapy of CC-486 (oral~     azacitidine) and pembrolizumab provides improved patient outcomes compared to pembrolizumab~     alone in patients with previously treated locally advanced or metastatic non-small cell lung~     cancer.~   "
77929|NCT02546973|"~     A national study of a three year cohort consisting of all patients diagnosed with anal cancer~     in 2011- 2013 with data retrieval from three national registries: Cancer Registry, Patient~     registry and Cause of Death Registry all within the Swedish Board of Health and Welfare. All~     out- and inpatient visits with diagnoses, admission dates and discharge dates will be~     requested including.~      Patient documentation from the concerned hospitals will be collected and data on the details~     of the treatment collected retrospectively in a standardised fashion using a clinical record~     form.~      Comorbidity will be calculated using data from the Patient Registry using all main and~     co-diagnoses 2 years prior and then at least two years after treatment cessation.~      Detailed questionnaires will be sent out once at 2-3 years and a second time at about 6 years~     after index treatment.~   "
77930|NCT02546960|"~     The purpose of this study is to evaluate the safety, tolerability of different doses of~     JNJ-63871860 (ExPEC4V) in participants greater than or equal to (>=)18 years of age and to~     evaluate the dose-dependent immunogenicity of ExPEC as measured by enzyme-linked~     immunosorbent assay (ELISA).~   "
77942|NCT02546804|"~     Periodontal Disease is a ubiquitous in nature affecting about 80% population of India. The~     Periodontal Disease is a multifactorial but the dental plaque is considered as main~     etiological agent.The dental plaque, a adhesive bacterial coating accumulate around and in~     between teeth, if not removed by effective daily brushing and flossing, plaque can cause Gum~     infection and tooth loss. Though, many scientific periodontal procedures are available to get~     the treatment but because of lack of man power and poor socioeconomic condition it is not~     possible for every group of population in our India.~   "
77943|NCT02546791|"~     This is a retrospective, multicenter, descriptive analysis of patients with a diagnosis of~     chronic myeloid leukemia, treated with dasatinib for at least 45 days. The study will include~     100 patients treated in different public centers in the Mexican Republic.~   "
78041|NCT02545517|"~     The aim of this study is to evaluate the long-term (up to approx.10 years) persistence and to~     assess the boostability of immune responses in subjects who received a primary series of~     accelerated or conventional rabies PrEP IM regimen.~   "
77931|NCT02546947|"~     Mortality in Acute Respiratory Distress Syndrome (ARDS) is high (40 to 60 %). Protective~     mechanical ventilation is the cornerstone of the ARDS therapeutic strategies. Recently, a~     prospective multicenter study demonstrates that short-term infusion of neuromuscular blocking~     agents (NMBA) reduces hospital mortality. However, the mechanisms through which NMBAs could~     improve survival remain speculative and the dose of NMBA needed to observe a beneficial~     effect is still debated. In hypoxemic ventilated patients, continuous cisatracurium infusion~     with an objective of no response at orbicularis oculi to train-of-four (TOF) stimulation and~     an objective of two responses had similar effects on respiratory parameters. In their study,~     Papazian and colleagues used cisatracurium with an initial standard dose of 15 mg followed by~     a continuous infusion of 37.5mg/h, based on previous results of studies with patients~     monitored for paralysis. Atracurium and its stereoisomer cisatracurium are non-depolarizing~     neuromuscular blocking drugs, both used in anaesthesia and intensive care units.~      The aim of this study was to compare in ARDS patients a dose adjustment of~     continuous-atracurium intravenous infusion with an end point of one or two response at~     orbicularis oculi to TOF stimulation, and a dose adjustment to achieve clinical goals of~     protective ventilation without monitoring of TOF stimulation.~   "
77932|NCT02546934|"~     ABX Plus Cisplatin Versus Gemcitabine Plus Cisplatin in Triple Negative Breast Cancer (TNBC)~   "
77933|NCT02546921|"~     This first in human study of the new therapeutic antibody MOv18 IgE in patients with advanced~     cancer seeks to demonstrate the potential for the use of this IgE antibody as an example of~     the use of the IgE class of antibodies for the treatment of cancer.~   "
77934|NCT02546908|"~     The purpose of this study is to document prostate cancer (PC) management including diagnosis,~     prognosis, treatment, and care in real-world practice.~   "
77935|NCT02546895|"~     Head and neck cancers account for the sixth leading cause of cancers worldwide. The annual~     incidence of Head and neck cancers is more than 650,000 the patients each year. Head and neck~     cancers are associated with smoking, alcohol consumption, human papilloma virus (type 16 and~     18) and previous exposure to radiation.~      So far, most of clinical and research data about head and neck cancers, such as the etiology,~     pathogenesis, prognosis factors and associated factors, treatment outcomes, are from Western~     countries. However, due to various environmental factors, for example race, genetics,~     geographical factors, general hygiene and health care system differences, the possibility of~     differences of disease characteristics between Western and Asian people should be considered.~      For several decades, there have been many studies about treatment modalities (surgery,~     chemotherapy, and radiation therapy), complications and side effects for head and neck~     cancers in the West. Many institutions tried to improve the survival rate and resolve the~     toxicity of chemotherapy and radiation treatment for head and neck cancer patients. However~     there has been little information about the characteristics of head and neck cancers,~     effectiveness of treatment (survival rate, recurrence, and complication rate), and prognosis,~     particularly in Korean as well as in Asian patients.~      Therefore it is necessary to evaluate and analyze the features of head and neck cancers such~     as etiology, pathogenesis, risk factors, prognostic factors, treatment outcomes in a site~     specific cohort (South Korea) separately. It could be helpful to improve the treatment~     outcomes of head and neck cancers overall, to design race or site specific treatments for~     head and neck cancers, and to develop management strategy common in Asia as well as the West.~      The purpose of this study is~        1. To establish the prospective tumor registry about patient's information,~          treatment-related morbidities, treatment outcomes and quality of life, in addition to~          the prospective collection of patient samples (blood and tumor tissues).~        2. To establish the predictive model for treatment outcomes and treatment-related~          morbidities.~        3. To develop the biomarkers as predictive and/or prognostic factors.~   "
77936|NCT02546882|"~     The purpose of this study is to observe whether the transplantation of autologous stromal~     vascular fraction (SVF) in adipose tissue is safe and its effect on improving the texture and~     contracture of skin grafting.~   "
77937|NCT02546869|"~     This multi-center, single-arm study is designed to evaluate clinical experience of~     participants (or caregivers) administering lebrikizumab at home in participants with asthma.~     Eligible participants will receive four doses of subcutaneous (SC) lebrikizumab every 4 weeks~     (q4w) up to Week 12. Primary analysis visit occurs at Week 13. After study treatment, all~     participants will complete a 12 week safety follow up. All participants will get training for~     the administartion of lebrikizumab using the device.~   "
77938|NCT02546856|"~     Introduction: Heart Failure (HF) generates multiple hospital admissions and mortality, which~     are reduced with the administration of Beta-Blocker (BB), Angiotensin Converting Enzyme~     Inhibitor (ACEI), Angiotensin II Receptor Blocker (ARB) and Mineralocorticoid Receptor~     Antagonist (MRA) drugs (Level of Evidence A). The effect is dose-dependent. Nevertheless,~     dosages are suboptimal. European Guidelines 2012 recommend close monitoring and up-titration~     of drugs by HF nurses. Trials are needed to evaluate their effectiveness and safety.~     Objective: To compare doses achieved by patients of BB, ACEI, ARA II and ARM in 4 months ( %~     relative to target doses) in the intervention group (HF nurse) and in the control group (~     cardiologist), adverse events, Left Ventricular Ejection Fraction (LVEF), New York Heart~     Association (NYHA), 6 min. walking test, quality of life, Nt-proBNP, readmissions and~     mortality. Hypothesis: Non-inferiority. Design: Multicenter randomized controlled trial. New~     (de novo) HF patients with LVEF ≤ 40%, NYHA II-III, without contraindications to BB of 17~     Spanish hospitals will be included. Intervention: The cardiologist prescribes drugs and,~     driven by protocol, the HF nurse implements the up-titration. In the control group doses are~     decided by the cardiologist clinical support and education being provided by nurses.~     Variables: age, sex, education, psycho-social level, Cardio Vascular Risk Factors (CVRF),~     NYHA, LVEF, ischemic cardiopathy., N-terminal pro B-type natriuretic peptide (Nt-proBNP),~     6min. walking test, Creatinine/Glomedular Filtration Rate (GFR), Potassium (K), haemoglobin,~     Blood Preassure (BP), Heart Rate (HR), mg./drug, European Heart Failure Self-Care Behaviour~     Scale (EHFScBS), Minnesota Living with Heart Failure questionnaire (MLHFQ), European Quality~     of life Scale (EQ-5D). Expected Results: If our hypothesis were confirmed, evidence would be~     provided on the effectiveness of this healthcare management, that could be economically~     evaluated in future studies. A qualitative study also will be undertaken to explore barriers~     and facilitators to implementation~   "
77939|NCT02546843|"~     This randomized study prospectively evaluates our experience with administration of~     cisatracurium and rocuronium antagonized by sugammadex and evaluates the effects of various~     depths of neuromuscular blockage on providing optimal surgical conditions during laparoscopy~     with low-pressure capnoperitoneum.~   "
77940|NCT02546830|"~     The aim of the study is to assess the use feasibility of the FreeO2 system so as to deliver~     automatically oxygen in the post anesthesia care unit in a patient population admitted for~     major abdominal and thoracic surgery.~      The investigators' hypothesis is that FreeO2 system will provide a better control of the~     oxygen saturation and reduce postoperative hypoxaemia.~   "
77941|NCT02546817|"~     To assess the real-world safety/effectiveness of Eliquis in Korean venous thromboembolism~     (VTE) patients and patient characteristics that are associated with bleeding among patients~     taking Eliquis. To identify factors that might be associated with the safety and~     effectiveness profile in Korean VTE patients.~   "
78042|NCT02545504|"~     The primary objective of this study is to compare the efficacy of andecaliximab (formerly~     GS-5745) versus placebo in combination with modified fluorouracil (5-FU), leucovorin (LV),~     and oxaliplatin (OXA) (mFOLFOX6) as measured by overall survival.~   "
77944|NCT02546778|"~     Nowadays increasingly quest for improved physical appearance, gradually developing the~     medicine of beauty, where the radio fits as an additional tool in helping some aging~     processes and maintenance of body shape. The aim of this study was to evaluate and compare~     the changes in the thickness of adipose tissue and blood levels of some biochemical markers~     of sedentary and active women who underwent radio frequency technique via ultrasound imaging~     and laboratory tests. Seven (7) sessions were held, each lasting 20 minutes each, 22~     volunteers allocated into two groups, sedentary and physically active. Measures ultrasound~     image were collected at baseline, pre-treatment and post-treatment period period and serum~     biochemical parameters (lipid profile, liver and kidney) for the pre-treatment and~     post-treatment.~   "
77945|NCT02546765|"~     Investigators will assess the incidence and duration of postoperative delirium in patients~     ≥60 years old undergoing Coronary Artery Bypass Grafting (CABG), with/without valve surgery~     (aortic and/or mitral) based on different regimens for postoperative sedation and analgesia.~     Patients will receive either intravenous (IV) dexmedetomidine and IV acetaminophen or~     standard postoperative management using IV propofol with morphine or hydromorphine. The~     Confusion Assessment Method (CAM) will be used to assess delirium in these patients.~     Investigators also seek to compare postoperative (48 hours) analgesic requirements in~     patients with or without IV acetaminophen. Investigators will finally assess postoperative~     cognition in post-surgical patients up to one year post-discharge using a cognitive~     assessment scale.~   "
77946|NCT02546752|"~     This primary goal of this study is to assess whether patient whose parents watch a~     standardized digital video using the integrated digital approach during a routine office~     visit are more likely to accept a dose of HPV vaccine (1st, 2nd, or 3rd dose) compared to~     those not completing the program. The study team anticipates eligible patients in the~     intervention clinics to have higher rates of HPV vaccine acceptance (1st, 2nd, or 3rd doses)~     than patients in the usual care comparison clinics.~      Additionally, the study team is interested in determining the impact of the integrated system~     on clinical workflow by measuring the number of minutes of each patient office visit when~     using the system compared to the number of minutes of each visit in offices where the system~     is not used.~      Although this is a descriptive/exploratory aim, our expectation is that the THEO system will~     have minimal impact on patient flow.~   "
77947|NCT02546739|"~     This study aims to evaluate the safety, efficacy and duration of response of CD19 Chimeric~     Antigen Receptor (CAR) redirected autologous T-cells in patients with high risk, relapsed~     CD19+ haematological malignancies.~   "
77948|NCT02546726|"~     This study is intended for inactive, middle-aged adults with untreated pre-hypertension who~     live in the Urbana-Champaign area, who are interested in a comprehensive program designed to~     enhance physical activity & reduce blood pressure. All participants will be asked to engage~     in a program developed in accordance with American Heart Association's recommendations.~     Specifically, the program will encourage and support lifestyle behavior changes such as~     quitting smoking, eating heart-healthy food, and reducing excessive alcohol, in addition to~     weekly exercise. The exercise program will involve a 14-week aerobic training program (3~     weekly sessions, scheduled at study participants' convenience), and 2 pre- and 2-post-testing~     sessions.~   "
77949|NCT02546713|"~     The aim of this study is to evaluate the effect of abutment macro-design on soft and hard~     tissue responses. This trial is designed as a randomized controlled clinical study in which~     two groups of fourteen partially edentulous patients will have as part of their treatment one~     implant placed in the maxillary premolar region.~   "
77950|NCT02546700|"~     Phase II, randomized, double-blind, placebo-controlled, parallel-group clinical trial of~     lebrikizumab in participants with COPD and a history of exacerbations who are treated with~     inhaled corticosteroid (ICS) and at least one long-acting bronchodilator inhaler medication.~     This study will be conducted to assess the safety, efficacy, and patient-reported outcome~     (PRO) measures.~   "
77951|NCT02546687|"~     Esophageal resection becomes a routine surgical procedure in many medical centers. Usually~     reconstruction after esophagectomy is achieved by gastric pull-up with cervical or~     intrathoracic anastomosis. The only blood supply for this gastric tube is by right~     gastroepiploic arcade. Bad or borderline perfusion of gastric tube is the main reason for~     future anastomotic leaks or strictures.~      The investigators suggest to measure components of venous blood gases (O2, pH, CO2, lactate)~     from the area of future anastomosis before construction of gastric tube and just before~     creation of anastomosis ( after 15-30 minutes), compare the results of this analysis with~     systemic venous blood.~      The investigators suppose that elevation of acid features of blood (pH decreasing, lactate~     increasing etc.) as expression of tissue ischemia after gastric tube creation maybe the~     significant predictive sign for future anastomotic leaks or strictures.~      After operation the investigators plan to find relationship between the blood gas changes and~     rate of anastomotic leak and stricture.~      This is prospective study. Anticipated cohort of 50 patients~   "
77952|NCT02546674|"~     The main purpose of this study is evaluation of deep molecular response (MR4.5; BCR-ABL IS <~     0.0032%) after 24 months of therapy with nilotinib in newly diagnosed patients with chronic~     phase CML. Via the use of MR4.5 EUTOS ('European Treatment and Outcome Study for CML')~     laboratories adequate and reliable molecular monitoring as a key parameter for assessing~     molecular milestones is fostered. Furthermore this trial aims to investigate early prediction~     of outcome in newly diagnosed patients with nilotinib by assessing the individual decline of~     BCR-ABL transcripts. Quality of life will bemeasured via use of the EORTC CML-24~     questionnaire.~   "
77953|NCT02546661|"~     This is an open label, multi-drug, biomarker-directed, multi-centre, multi-arm, randomised~     Phase 1b study in patients with muscle invasive bladder cancer (urothelial) who have~     progressed on prior treatment. This study is modular in design, allowing evaluation of the~     safety, tolerability, pharmacokinetics and anti-tumour activity of multiple agents as~     monotherapy and as combinations of different novel anti-cancer agents in patients with muscle~     invasive bladder cancer.~      The study will consist of a number of study modules (substudies), each evaluating the safety~     and tolerability of a specific agent or combination~   "
77954|NCT02546648|"~     A placebo-controlled, factorial trial to assess the impact of rosuvastatin and tranexamic~     acid (TXA) in patients undergoing noncardiac surgery who are at risk of a perioperative~     cardiovascular event.~   "
77955|NCT02546635|"~     Part A: Food effect (a single oral dose of 500 mg AX-024.HCl under fasted and fed states)~     Eight (8) healthy male volunteers will receive a single dose of 500 mg AX-024.HCl in the~     fasted state (10 h overnight fast), and will return 2 weeks later to receive the same dose of~     AX-024.HCl following a meal.~      Part B: Multiple doses (a once daily dose of AX-024.HCl or Placebo for 10 days).~      Part B is a double-blind, dose escalating, placebo controlled, randomised, multiple dose~     study to assess the tolerability, safety and pharmacokinetics in 24 healthy male subjects.~     Subjects will be allocated to one of 2 dosing cohorts. Each cohort will have 12 subjects with~     9 subjects randomised to receive AX-024.HCl and 3 subjects randomised to receive placebo.~      There will be a data review following each dose level. Dose administration in the subsequent~     cohorts will only proceed after satisfactory data review on the blinded safety data and~     plasma PK data in the previous cohort.~   "
77956|NCT02546622|"~     This is a longitudinal, observational study of patients with Hemophilia A or B who are~     planning to switch to a newly approved coagulation factor replacement product, or who have~     recently switched factor products. The study will follow each patient for up to 1 year.~     Patients will be recruited at Hemophilia Treatment Centers (HTC) which are ATHN-affiliates.~     The primary outcome being studied is the development of inhibitor (i.e., antibodies to~     factor) at 1 year or 50 exposure days, whichever comes first.~      The study will be conducted at approximately 30 HTCs, with a planned enrollment of 600~     patients.The entire study duration is projected to be approximately 6 years.~      In addition, optional substudies will be included for some products, as Product-Specific~     Modules. These will be questionnaires to collect data for subjects receiving selected Factor~     products. For example, subjects receiving Eloctate will be approached to participate in the~     'Eloctate Product-Specific Module'; subjects receiving Adynovate will be approached to~     participate in the 'Adynovate Product-Specific Module'. Questions will be related to product~     use, perceptions of product use, and other post-marketing consumer data.~   "
77957|NCT02546609|"~     The goal of this study is to determine if NS-0200 can reduce the amount of liver fat in~     patients diagnosed with non-alcoholic fatty liver disease (NAFLD). This study will compare~     two doses of NS-0200 to placebo in NAFLD patients.~   "
77958|NCT02546596|"~     Preoperative radiotherapy in locally advanced rectal cancer increases the possibility of~     complete resection and anal sphincter preservation. However, a treatment period of from 5 to~     6 weeks is an obstacle of proper surgical intervention. Also, radiotherapy itself is~     confronting challenges for maximizing the therapeutic effect and minimizing the side effects.~     Electro-hyperthermia is appropriate treatment method to solve these kinds of problems. In~     this clinical trial, therapeutic effect of the high-frequency electro-hyperthermia is to be~     verified during preoperative radiotherapy for locally advanced rectal cancer. The ultimate~     goal is to establish a safe and effective treatment protocol.~   "
77959|NCT02546583|"~     Effective diuresis is the primary goal of most acute decompensated heart failure~     hospitalizations, but diuretic resistance is common and our ability to detect it is limited.~     Further, there are therapeutically distinct groups of diuretic-resistant patients. These are~     not easily distinguished using currently available methods, leading to trial-and-error based~     treatment that promotes lengthy hospitalizations.~      The aims of this study are:~        1. To develop inexpensive and efficient tools to predict diuretic response~        2. To understand the prevalence of therapeutically targetable mechanisms of diuretic~          resistance using endogenous lithium clearance~        3. To develop methodology to differentiate diuretic resistance mechanisms using~          common/inexpensive laboratory tests~        4. To provide proof of concept that mechanistically tailored diuretic therapy can improve~          natriuresis~   "
77960|NCT02546570|"~     The investigators will use multiple methods (including Oxytocin intranasal inhalation,~     neuroimaging, behavioral measures, peripheral hormone measurements) to examine how~     individuals' behavior, cognition, and brain function is impacted by the neuro-hormone~     Oxytocin. Specifically, the investigators plan to evaluate the influence of Oxytocin~     administration on affective processing in non-trauma exposed and trauma-exposed adults (both~     with and without posttraumatic stress disorder, PTSD).~   "
77961|NCT02546557|"~     The study is a voluntary study, initiated by B. Braun to collect clinical data for Optilene®~     suture concerning its key indication.~   "
77962|NCT02546544|"~     This is an international, multi-centre, single arm Bayesian designed phase 2 study to~     identify and determine the safety and activity of anti-IGF-1/IR inhibition in patients with~     relapsed and/or refractory ESFT. Approximately 40 patients will be recruited from 5-7~     European centres. Each patient will be treated with single agent linsitinib, 600 mg orally~     once a day for days 1-3, 8-10 and 15-17 on a 21 day cycle until disease progression or undue~     toxicity.~   "
77963|NCT02546531|"~     In pancreatic cancer, targeting the tumor microenvironment has become a promising therapeutic~     strategy. Focal adhesion kinase (FAK) pathway activation is essential for promoting a~     fibrotic and inflammatory tumor microenvironment, and FAK inhibitors have demonstrated~     reasonable anti-tumor activity in the preclinical setting. Furthermore, a maximal synergetic~     effect was achieved when a FAK inhibitor was given in combination with a PD-1 antagonist and~     chemotherapy in multiple pancreas tumor animal models. This supports the concept of using FAK~     inhibitors to reduce stromal fibrosis during checkpoint immunotherapeutic treatment.~     Therefore, these robust preclinical findings will be tested in the proposed phase I trial.~   "
77984|NCT02546258|"~     This is a prospective, open label, non-comparative clinical investigation to evaluate the~     performance of a Fungal Nail Treatment on the visual signs of onychomycosis.~      The Fungal Nail Treatment is a CE Marked Class I Medical Device and is commercially available~     as an over-the-counter product.~      The ability of the Fungal Nail Treatment to treat the visual signs of mild fungal toenail~     infections will be determined by a reduction in the surface area of the infection over time.~     This will be assessed through visual quantification of the infected area from baseline, as~     measured by image analysis, throughout the treatment period, where subjects will follow~     instructions for use on the product pack and self-treat for the duration of the investigation~     or until their condition has resolved. Both subject and podiatrist will assess the~     improvement of signs and symptoms of the target nail.~   "
78070|NCT02545140|"~     The primary aim of PRE-STARt Phase 1 is to pragmatically evaluate and refine a risk~     assessment tool to identify those children with chronic disease risk factors (including Type~     2 Diabetes).~   "
77964|NCT02546518|"~     Secretory otitis media (SOM) or middle ear effusion is a common finding affecting children in~     the age of 4-5 years. It is usually associated with 5-15 deci Bells hearing loss. Although~     spontaneous resolution with normalisation of hearing is the usual outcome, this can take~     several months. Secretory otitis media is the most common cause of hearing impairment in the~     paediatric age group. When the hearing loss caused by SOM is bilateral and persists for 3-6~     months or more, surgery with tympanostomy tube insertion under general anaesthesia is~     indicated. In Sweden, 10000 children undergo this operation annually. Although many children~     with unilateral or bilateral SOM improve in the summer, the problem usually recurs in the~     autumn or winter. The cost of SOM for the Swedish society was 600 million Swedish crowns~     2005.~      In two previous studies, the investigators concluded that the nonsurgical treatment method,~     that was developed to assist children with SOM equalising their middle ear pressure, could~     normalise the hearing level in 80 % of children with SOM of minimum duration of 3 months.~     These children avoided therefore grommet insertion.~      The investigators would like to assess the effect of this new treatment method on mainly the~     hearing threshold of children with SOM. The investigators expect that using the new method~     could help children with SOM avoid operation with grommet insertion.~   "
77965|NCT02546505|"~     Introducing Front-Of-Pack (FOP) nutrition labelling, providing simplified information on~     nutritional content at a glance, in order to help consumer make informed choices, has been~     identified as of major interest by public health specialists. In France, a recent report to~     the Minister of Health has proposed the introduction of a Front-of-Pack nutrition label, the~     5-Colour nutrition label. Existing studies on FOP labels mainly focused on assessment of~     consumers' acceptability/liking and understanding. If most of the studies on purchasing~     behavior, conducted in real supermarkets, suggested a positive effect of FOP labels on~     consumers' food choices, the impact of the 5-CNL has not been evaluated.~      The main objective is to evaluate the impact of a Front-of-pack nutrition label, the 5-Colour~     Nutrition Label on consumer purchases in a controlled environment close to real-world~     settings. Nutritional quality of the items purchased will be compared using the Food~     Standards Agency nutrient profiling system (FSA score). The study relies on a comparison~     across three independent samples :~        -  Control group: The current situation with current way brands show or not nutritional~          information on Front of Pack (FoP) - without consumer information~        -  Intervention n°1: Introduction of a Front-of-pack nutrition label (5-CNL) on selected~          categories of foods. No additional consumer information~        -  Intervention n°3: Introduction of a Front-of-pack nutrition label (5-CNL) on selected~          categories of foods. Additional consumer information specifically targeting nutritional~          information and explaining the 5-CNL will be performed (this information will consist in~          a concept shown to respondents before the shopping session).~      Participants are recruited in the street through quota sampling, based on criteria of gender,~     age and purchasing habits on the products categories selected for the introduction of the FOP~     nutrition label.~      The study relies on LabStores®, i.e. shopper laboratory stores, which are controlled study~     spaces in which a store is recreated in reality.The real lab store mimics a store environment~     with real shelves, product, and cash register, and presents several product categories in a~     realistic shopping environment. At the end of the shopping session, the respondents proceed~     to the cashier but don't actually pay for their purchases.~      The selected foodstuffs come from actual retailers' brand products available on the French~     market. Three categories of products were selected, based on expected variability in~     nutritional quality of the products and logistic criteria (exclusion of fresh products):~        -  Breakfast cereals~        -  Sweet biscuits~        -  Salty snacks The impact of the different labels on nutritional quality (FSA score,~          calories, lipids, saturated fatty acids, sugars, proteins, fibre, sodium) of the~          shopping cart is investigated using one way ANOVA. Pairwise comparisons among FOP labels~          are assessed by using Tukey's multiple comparisons tests.~      All tests of significance are two-sided, and a P value <0.05 is considered significant.~     Statistical analyses are performed using SAS software (version 9.3; SAS Institute Inc.).~   "
77966|NCT02546492|"~     This is an open label safety and feasibility trial using Acthar® in addition to the~     investigators center-specific standard therapy, which could include increase in maintenance~     immunosuppression, high dose IVIG (2 g/Kg), and/or Rituximab, in patients with CAMR.~   "
77967|NCT02546479|"~     Background:~      Scoliosis is a curving of the spine. It usually happens in girls when they are children and~     teens. Doctors often use x-rays to diagnose it. The x-rays give low radiation. This may~     increase the risk that those young women get cancer later in life. Researchers want to learn~     more about this risk. They will look data that has already been collected.~      Objectives:~      To study cancer risks of repeated low radiation from x-rays for scoliosis. Also, to study~     death risks related to certain scoliosis patient characteristics. These include causes, kinds~     of curvature, and kinds of treatment.~      Eligibility:~      Medical records of women from past scoliosis studies.~      Design:~      This U.S. Scoliosis Cohort includes more than 5,000 women who were diagnosed between 1912 and~     1965.~      Data were collected on these women in the 1980s and 1990s. These came from medical records,~     radiology log books, and x-ray films. Researchers found out where participants were,~     including if they were dead. Some women were given a follow-up questionnaire.~      Researchers want to find out where participants are today. They want to identify new deaths~     of participants. They want to find out their causes of death. This data will be added to~     other databases.~   "
77968|NCT02546466|"~     Background: Low back pain is a major public health problem that affects most people at some~     point in life, and results in major psychosocial, economic, functional and physical~     consequences that can last for days and months. Most cases are undiagnosed and become chronic~     non-specific low back pain. Studies showed that these patients presented changes in postural~     control, yet the information is inconsistent, as well as the effects of Functional Taping~     (FT).~      Objectives: The aim of this study will be to investigate the immediate and one-month~     follow-up effects of the use of Functional Taping to lumbar spine on pain intensity and~     postural control in patients with chronic nonspecific low back pain (CLBP).~      Methods: This study will be a sham-controlled and randomized clinical trial. Participants:~     One hundred and twenty participants (18 and 50 years) both genders. Interventions:~     Participants will be randomly allocated to receive three possible interventions: Functional~     Star-shape Taping, Sham Functional Taping (both interventions during seven days) and a~     Minimal Intervention (MI) (one session). Main outcome measures: Primary outcomes will be pain~     intensity and posturography to assess balance parameters. Low back pain related disability,~     global perceived effect of treatment and fear avoidance beliefs will be considered as~     secondary outcomes. Four measurements of static posturography will be conducted:~     pre-intervention, immediately after application of the tape, after seven days~     post-intervention (after removal of the tape) and after one month follow-up period. Secondary~     and primary outcomes will be assessed on three occasions: pre-intervention, seven days~     post-intervention and after one month follow-up period. All statistical analysis will be~     conducted following the principles of intention to treat, and the effects of treatment will~     be calculated using linear mixed models.~   "
77969|NCT02546453|"~     The search for genetic alterations in primary tumor by NGS techniques followed by the~     detection of these alterations in circulating tumor DNA and/or CTC/DTC present in peripheral~     samples (blood, cerebrospinal fluid, bone marrow, possibly urine) collected during several~     steps and after the treatment could be a tool to monitor the response during and after the~     treatment.~   "
77970|NCT02546440|"~     The main objective of the trial is to investigate whether oral treatment of patients~     suffering from cutaneous T cell lymphoma with dimethylfumarate is leading to a significant~     improvement of modified severity assessment tool (mSWAT) values in the skin after 24 weeks of~     treatment (primary endpoint). Secondary endpoints will be CTCL severity index, dermatologic~     life quality index, itching measured by a VAS and the blood involvement if applicable.~      Primary: safety and efficacy of DMF treatment in CTCL Secondary: CTCL severity index,~     Dermatologic Life Quality index, VAS for itching, blood involvement if appl.~   "
78071|NCT02545127|"~     This trial investigates the safety and efficacy of FE 202767 compared to placebo in~     increasing milk production in subjects with preterm delivery and inadequate milk production.~   "
77971|NCT02546427|"~     This is a phase I feasibility study to evaluate the feasibility of hypofractionated whole~     pelvis radiotherapy in 35 patients with biopsy-proven intermediate- to high-risk prostate~     cancer as defined by NCCN risk criteria. Patients will have >15% risk of lymph node~     involvement as defined by the Roach equation 2/3(PSA)+10(Gleason Score-6). Day 0 of the study~     will be defined as the time of first LHRH/agonist/antagonist injection of hormone therapy.~     Radiation therapy should begin within 8 weeks (+/- 1 week) after the date of the first LHRH~     agonist/antagonist injection. Patients will be followed at 6 weeks and then every 3 months~     for the first 24 months after completion of radiotherapy in a similar schedule to usual~     standard of care. A history and physical, PSA, testosterone and EPIC-26 questionnaire will be~     collected at each visit. Any toxicity according to CTCAE v. 4.0 criteria will be documented.~     An interim analysis for evaluating acute toxicity (≤90 days) will be performed after the~     first follow-up visit of the20th patient enrolled on protocol. The trial will be terminated~     if >30% acute grade 2 or >5% grade 3 or greater toxicity is observed as a result of radiation~     treatment by CTCAE v. 4.0 criteria. Grade 2 toxicity is defined as a minimal, local or~     noninvasive intervention. Grade 3 toxicity is defined as a severe or medically significant~     but not immediately life-threatening event requiring hospitalization or prolongation of~     hospitalization. Previous studies have demonstrated approximately 30% and 5% incidence of~     Grade 2 and Grade 3 or greater toxicity, respectively, with conventionally fractionated~     radiotherapy followed by brachytherapy.~   "
77972|NCT02546414|"~     To validate the PC/SD ratio to be used to predict the variceal haemorrhage in Chinese~     patients with hepatitis B virus (HBV)-associated hepatic cirrhosis.~   "
77973|NCT02546401|"~     The current study focuses on terms of use of Insulin Aspart, fast analogue of human insulin~     and commonly used in the treatment of type 1 diabetes, where it obtained the marketing~     authorization for this indication. In the patient who have an insulin pump, insulin Aspart is~     given daily like a pre-prandial bolus (just before the meal). However, many patients perform~     their bolus after the meal. However this insulin administration modality is not clearly~     studied in the literature.~   "
77974|NCT02546388|"~     The purpose of this research study to find out if a drug called OctreoScan or DOTATATE can~     help doctors diagnose people with cardiac sarcoidosis better.~      OctreoScan and DOTATATE are both approved by the U.S. Food and Drug Administration (FDA) to~     diagnose certain tumors.~   "
77975|NCT02546375|"~     The purpose of this study is to describe the efficacy and safety of bosutinib in patients~     with chronic myeloid leukaemia used in a real world setting~   "
77976|NCT02546362|"~     The objective of this pilot open trial is to investigate the efficacy and safety of e-TNS~     with the Cefaly(R) device in fibromyalgia.~   "
77977|NCT02546349|"~     It is recognized that eosinophilic airway inflammation is more likely respond to steroid~     treatment. However, in real-world practice, it is difficult to routinely assess airway~     inflammation using sputum induction because of technical and facility requirement. COPD~     (chronic obstructive pulmonary disease) is a heterogeneous disease and it remains a great~     challenge to identify patients who have eosinophilic airway inflammation and respond to~     steroid treatment well. A recent study demonstrated elevated plasma D-dimer was associated~     with acute inflammation and a significant predictor of pulmonary embolism in COPD exacerbated~     patients. D-dimer may potentially act as a marker of inflammation and a predictor of~     cardiovascular event in COPD patients. The investigators preliminary study demonstrated that~     exhaled nitric oxide (eNO) > 23.5 ppb is a good surrogate marker to predict eosinophilic~     airway inflammation in COPD patients who were newly diagnosed or untreated for at least 3~     months. There were significant correlations among sputum eosinophils, eNO and serum total~     immunoglobulin E (IgE). Particularly, eNO predicted sputum eosinophilia (> 3%) in COPD at a~     sensitivity and specificity of 62% and 71% respectively. Herein, the investigators test the~     hypothesis that eNO may act as a biomarker to determine treatment option for COPD.~   "
77978|NCT02546336|"~     Hip osteoarthritis (HOA) is a common cause of pain and disability in aging population.~     Conservative treatment is based on lifestyle modifications, physical therapy, analgesic and~     anti-inflammatory medications and intra articular injections. This Prospective Pilot Study~     aims at investigating the efficacy of Ultrasound-Guided Cooled Radiofrequency Hip Denervation~     as a treatment offered to patients with HOA.~   "
77979|NCT02546323|"~     The purpose of this study is to evaluate the effects of of rosuvastatin 20 mg compared to~     placebo for treating Chinese patients with subclinical atherosclerosis.~   "
77980|NCT02546310|"~     To determine if treatment with HTL0009936 will lead to changes in neural activity, measured~     using the fMRI BOLD signal and ASL, in brain areas that are associated with spatial and~     working memory, learning and executive functioning.~   "
77981|NCT02546297|"~     The purpose of this study is to determine which treatment is more effective and safer for the~     patients in COPD C group with bronchiectasis.The research results will help guide physicians~     to select appropriate individualized treatment and hopefully provide some evidence-based~     medicine proofs for revising guide.~   "
77982|NCT02546284|"~     This is a multicenter, open-label, repeat-dose, Phase 1 Dose Escalation Study to evaluate~     safety, pharmacokinetics, and clinical activity.~   "
77983|NCT02546271|"~     Gay Poz Sex (GPS) is an HIV prevention and sexual health promotion program for HIV-positive~     gay and bisexual men, which takes place in a group counselling format. All participants~     provided written informed consent at the outset of the study. Eligible participants filled~     out a 1-hour computer-assisted self-interview questionnaire. Subsequently, participants~     attended seven 2-hour group sessions, led by 2 peer facilitators, who were HIV-positive gay~     men, in groups of 5-8 men. Immediately and 3 months following the completion of the GPS~     program, participants were scheduled to attend a 1-hour session to complete the same~     questionnaire package. Participants received an honorarium and a list of community resources,~     including mental health or substance use counseling services, at the end of each assessment.~     Participants also participated in a program evaluation interview at the 3-month follow-up~     assessment.~   "
77985|NCT02546245|"~     The goal of the proposed research is to adapt and rigorously evaluate educational mobile~     games, designed as a downloadable mobile apps to be played on smartphones or tablets.~     Investigators will be partnering with Yogome for this project. Yogame is a company dedicated~     to creating educational games that aim to reinforce knowledge acquired in school and help~     children learn new things in an entertaining and fun way.~   "
77986|NCT02546232|"~     The purpose of the study is to investigate the molecular biology of the tumor in relation to~     treatment response to chemotherapy, in particular paclitaxel compared to the combination~     paclitaxel and carboplatin. The study is carried out in two different, separate cohorts:~      Cohort I: Patients with large primary breast cancer (> 2.0 cm) including locally advanced~     disease, are treated with weekly paclitaxel for 12 weeks, before continuing on anthracycline~     containing regimen for another 12 weeks before surgery. Patient are randomized 1:1 to receive~     carboplatin in addition to paclitaxel for the first 12 weeks of the treatment.~      Cohort II: Patients with metastatic disease, available for biopsies before and during therapy~     are included to receive paclitaxel for 24 weeks. Patients are randomized 1:1 to receive~     paclitaxel alone or paclitaxel in combination with carboplatin.~   "
77987|NCT02546219|"~     The overall objective of this preclinical study is to further the investigators mechanistic~     understanding of the role that the α4β7 and mucosal addressin cell adhesion molecule~     (MAdCAM-1) pathway plays in mediating eosinophil recruitment in EoE. To accomplish this, the~     investigators aim to (1) determine the baseline and dynamic patterns of α4β7 integrin~     expression on circulating and tissue eosinophils in EoE and in the setting of non-EoE~     esophageal eosinophilia (e.g., reflux esophagitis) and (2) determine the complete profile of~     eosinophil integrin molecules that may play a role in active EoE.~   "
77988|NCT02546206|"~     The aim of this study was to evaluate the effects of probiotic yoghurt on the development of~     gingival inflammation.~      Fifty-one periodontally healthy individuals were given standard oral hygiene instructions and~     randomly divided into two groups. The test group subjects (n=26) consumed probiotic yoghurt~     containing Bifidobacterium animalis subsp. lactis and the control subjects (n=25) natural~     yoghurt for 28 days. Following yoghurt consumption, mechanical plaque control was interrupted~     for the next 5 days in both groups. Gingival crevicular fluid (GCF) samples and clinical data~     (consisted of plaque and gingival indices, probing depth, bleeding on probing) were collected~     at baseline, after 28 and 33 days. Interleukin-1β levels were determined in GCF by ELISA.~   "
77989|NCT02546193|"~     Induction of labor, or causing labor to start before it otherwise starts spontaneously, is~     sometimes necessary as pregnancy progresses to ensure the safety of both mother and infant.~     Labor induction often begins with cervical ripening, in which various methods are used to~     prepare the cervix for contractions and labor. Cervical ripening is beneficial and decreases~     the need for cesarean section; however, it can be a lengthy process. By tradition, pregnant~     women are admitted to the hospital at the start of this process and remain inpatient until~     after the baby is born.~      There is increasing interest in allowing the mother to return to her own home during the very~     first part of this process. She may be more satisfied in a more comfortable environment with~     her family. Growing scientific evidence supports use of the Foley catheter as an approach to~     outpatient cervical ripening. The Foley catheter is a safe, effective method that is already~     used often in the inpatient setting. It does not cause increased health risks for either~     mother or baby. Previous research studies have shown that it is just as safe and effective~     when women return to their own homes with a Foley catheter and that women spend less time in~     the hospital before delivery. More information is needed before this becomes a standard of~     care. This research study will allow pregnant women to return home for the first night of~     their labor induction with a Foley catheter in place. In the morning they will return to the~     hospital and stay until after delivery. They will be compared to a group of women who remain~     in the hospital for their entire labor induction. The benefits to going home during labor~     induction may include increasing maternal satisfaction and optimizing the use of resources in~     the hospital.~   "
77990|NCT02546180|"~     This prospective randomized pilot clinical trial studied the effect on preoperative anxiety~     of watching a series of YouTube videos designed to create a virtual hospital experience for~     patients undergoing primary total hip and knee arthroplasty as compared to routine~     preoperative education.~      Hypothesis: Preoperative anxiety related to hip and knee replacement surgeries can be reduced~     by patient exposure to a virtual hospital inpatient experience delivered by a series of~     YouTube videos.~   "
77991|NCT02546167|"~     Open-label, single-center, pilot study to assess the safety and feasibility of infusion of~     autologous T cells expressing BCMA (B-cell maturation antigen)-specific chimeric antigen~     receptors with tandem TCR and 4-1BB costimulatory domains (referred to as CART-BCMA ) in~     adult patients with multiple myeloma (MM). CART-BCMA cells will be given as a split dose~     intravenous infusion over 3 days. The duration of active intervention and monitoring is~     approximately 2 years.~   "
77992|NCT02546154|"~     The objective is to monitor and quality assure the efficacy, including effects on quality of~     life, and safety of Monofer® in Chronic Kidney Disease and Inflammatory Bowel Disease patient~     populations when Monofer® is used according to the Monofer® label (Summary of Product~     Characteristics, SPC) in current clinical practice and where standard routines are being~     followed.~   "
77993|NCT02546141|"~     This study was designed to obtain information about the change in postprandial amino acids in~     blood over time, after consumption of different dairy products, in an elderly population and~     how this relates to gastric emptying rate and feelings of satiety.~   "
77994|NCT02546128|"~     To assess whether the addition of Extra-corporeal Shockwave Therapy (ESWT) to a structured~     home-exercise programme has any additional benefit to patients with tendinopathies~   "
77995|NCT02546115|"~     To assess whether the provision of a tension night splint (TNS) device has any additional~     benefit in patients with chronic plantar fasciitis, compared to routine care comprising~     physiotherapy & podiatry alone.~   "
77996|NCT02546102|"~     ICT-107 consists of dendritic cells, prepared from autologous mononuclear cells that are~     pulsed with six synthetic peptides that were derived from tumor associated antigens (TAA)~     present on glioblastoma tumor cells. This is a Phase 3 study to evaluate ICT-107 in patients~     with newly diagnosed glioblastoma. Subjects will be randomized to receive standard of care~     chemoradiation (temozolomide (TMZ) with either ICT-107 or a blinded control. Reinfusion with~     the pulsed dendritic cells should stimulate cytotoxic T cells to specifically target~     glioblastoma tumour cells.~   "
77997|NCT02546089|"~     To investigate whether a procedure of ultrasound-guided autologous blood injections (ABI),~     which includes a dry-needling component within the overall procedure, has any measureable~     clinical benefit over ultrasound-guided dry needling alone in patients with chronic plantar~     fasciitis.~   "
77998|NCT02546076|"~     Skin injuries due to trauma are relatively common, and patients are very concerned about~     scars caused by trauma and primary repair. Recently, the use of ablative and non-ablative~     lasers based on the fractional approach has become a novel strategy for the treatment of~     scars.~      The objective of this study is to compare the efficacy of dual-mode Er:YAG laser delivering~     pulses either with and without heat/coagulation in a cohort of patients with long~     keloid/hypertrophic scars.~      The main hypothesis is that ablative fractional laser without heat/coagulation is equivalent~     to laser with heat/coagulation in terms of scars volume reduction, while the secondary~     hypothesis is that ablative fractional laser without heat/coagulation is superior in terms of~     post-operative erythema and hypopigmentation reduction.~   "
77999|NCT02546063|"~     The standard method for determining the carbohydrate content of a meal in patients with~     diabetes mellitus is the weighing of individual foods. However, in daily life, the weighing~     is not practical at all times. Inaccurate estimation of meal's CHO content, leads to wrong~     insulin doses and consequently to poor postprandial glucose control. Fact is that even well~     trained diabetic individuals find it difficult to estimate CHO precisely and that especially~     meals served on a plate are prone to false estimations underlining an emergent need for novel~     approaches to CHO estimation.~      GoCarb is a computer vision-based system for calculating the carbohydrate content of meals.~     In a typical scenario, the user places a credit card-sized reference object next to the meal~     and acquires two images using his/her smartphone. A series of computer vision modules~     follows: the plate is detected and the different food items on the plate are automatically~     segmented and recognized, while their 3D shape is reconstructed. On the basis of the shape,~     the segmentation results and the reference card, the volume of each item is then estimated.~     The CHO content is calculated by combining the food types with its volumes, and by using the~     USDA nutritional database. Finally, the results are displayed to the user.~      A preclinical study using the GoCarb system indicates that the system is able to estimate the~     meal's CHO content with higher accuracy than individuals with T1D. Furthermore, the feedback~     gathered by the participants showed that the system is easy to use even for non-smartphone~     users.~      The aim of this randomized, cross-over pilot study is to investigate the benefits of an~     automated determination of the carbohydrate content of meals on glycemic control in subjects~     with type 1 diabetes mellitus with sensor-augmented insulin pump therapy.~   "
78000|NCT02546050|"~     OBJECTIVE: Investigate structural changes in the human gut microbiota and associated changes~     in metabolic markers in urine, saliva, blood and fecal samples following metformin treatment.~      DESIGN: An, 18 week, one-armed cross over intervention trial consisting of a 6-week~     pre-intervention period, 6-week intervention period and a 6-week post-intervention period. 25~     healthy young men will be included in the trial.~      INTERVENTION: Six-week Metformin treatment to young healthy men.~   "
78001|NCT02546037|"~     Primary Objective:~      The purpose of this study is to measure the amount of convection achieved with two different~     haemodiafilters designed for haemodiafiltration and clotting during haemodiafiltration~     treatment.~   "
78002|NCT02546024|"~     Depression is a common disorder, especially in old age, where it is associated with~     significant morbidity and mortality.~      This study will investigate whether there are features of individual patients with major~     depression that may predict positive treatment response. The study will invite 40 patients~     who have been diagnosed with major depressive disorder with onset after the age of 60 years~     to participate. Participants will be recruited from the Mental Health of Older Adults~     services at the South London and Maudsley NHS Mental Health Foundation Trust. Participants~     will receive usual treatment as set out in standard Care Pathways, used by the clinical care~     team. As part of the study, they will undergo a short battery of neuropsychological tests and~     a standard MRI brain imaging protocol. The neuropsychological tests and assessment of~     depression severity will be carried out twice (at Baseline and Week 12). Data will be~     analysed to investigate whether there are features specific to those patients who show a good~     response to antidepressant treatment after 12 weeks. Identification of such predictors may~     help to stratify treatment approaches in the future and lead to the early identification of~     individual patients who may require alternative treatment approaches to standard~     antidepressants.~   "
78003|NCT02546011|"~     The goal of this study is to compare the amount of time that the fetal heart tones are traced~     in babies just at or beyond viability using a traditional device compared to the Monica~     device.~   "
78004|NCT02545998|"~     The National Report of Asthma Deaths published in 2014 highlighted significant deficiencies~     in both primary and secondary care resulting in one of the highest mortality rates in Europe.~     A key recommendation in the report is the provision of an annual asthma review in primary~     care.~      Telehealthcare is an alternative means of service delivery incorporating the use of telephone~     and e-mail consultations which may improve access and quality of patient care. There is scant~     data on the role of teleheathcare in asthma care.~      This is a single-centre, primary care-based, randomized controlled trial to evaluate the use~     of telehealthcare to conduct the annual asthma review for adult patients with well-controlled~     asthma. This will be compared with standard care (face-to-face consultations).~      Telehealthcare will consist of a telephone consultation followed by an e-mail with an~     attached personalised asthma action plan and a link to a video demonstrating inhaler~     technique.~      Standard care will involve a face-to-face consultation in primary care. The two patient~     groups will be compared prospectively to determine whether there is a difference in the~     quality of care evaluated in terms of the patient experience/ satisfaction, health-related~     quality of life, asthma control and frequency of asthma exacerbations over a 6 month period~     after the asthma review.~      The data will be presented in the form of frequency tables, bar charts and pie charts.~     Non-parametric tests will be applied to determine whether there is a significant difference~     in the quality of care received.~   "
78005|NCT02545985|"~     The aim of this study was to assess the safety and the efficacy of the novel~     sirolimus-eluting Prolim® stent with a biodegradable polymer in the all-comers population.~   "
78006|NCT02545972|"~     This study investigates the use of tacrolimus extended release in stable patients who have~     undergone a heart transplant. All patients will receive the study medication free of charge~     for the 1 year duration of the study.~   "
78038|NCT02545556|"~     The purpose of this study is to evaluate the safety and efficacy of HepaSphere interventional~     therapy using digital subtraction angiography（DSA）combined with cryosurgery for liver cancer.~   "
78007|NCT02545959|"~     The goal of investigators is to study the kinetics of action of a single dose of~     intrathecally-infused rituximab upon cerebro-spinal fluid (CSF) biological targets in~     progressive MS patients. Various markers of central nervous system inflammation (osteopontin,~     Tumor Necrosis Factor α, IgG secretion) and neurodegeneration (neurofilament) are studied at~     multiple time-points, assuming that a definitive action upon CSF biological targets would be~     strongly predictive of a delayed clinical action.~   "
78008|NCT02545946|"~     Comparing the outcome of traditional incision and drainage with a larger skin incision with~     or without gauze packing of cutaneous abscess in pediatrics versus a new minimally invasive~     incision and drainage with two small incisions and a vessel loop transversing the incisions~     to keep them open.~   "
78009|NCT02545933|"~     Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 receptor inhibitor represents the~     standard of care for the long-term secondary prevention of atherothrombotic events in~     patients with myocardial infarction (MI). However, rates of ischemic recurrences remain high,~     which may be in part due to the fact that other platelet signaling pathways, such as~     thrombin-induced platelet aggregation, continue to be activated. Vorapaxar is a~     protease-activated receptor (PAR)-1 inhibitor, which exerts potent inhibition of~     thrombin-mediated platelet aggregation. It is approved for clinical use by the Food and Drug~     Administration for the reduction of thrombotic cardiovascular events in patients with a~     history of MI or with peripheral arterial disease. However, to date clinical trial experience~     with vorapaxar has been almost exclusively with the P2Y12 receptor inhibitor clopidogrel and~     the effects of vorapaxar in combination with antiplatelet therapy including prasugrel or~     ticagrelor, is largely unexplored. Further, the role of vorapaxar as part of a dual~     antithrombotic treatment regimen, in addition to a novel P2Y12 receptor inhibitor, with~     withdrawal of aspirin, represents another important area of clinical interest as it has the~     potential to maximize ischemic protection while reducing the risk of bleeding. The proposed~     prospective, randomized, parallel-design, open label, study conducted in a real world~     clinical setting of post-MI patients will aim to assess the pharmacodynamic effects of~     vorapaxar in addition to antiplatelet therapy with a novel P2Y12 receptor inhibitor~     (prasugrel or ticagrelor) with and without aspirin.~   "
78010|NCT02545920|"~     This is a prospective observational pilot study of patients under the care of the Royal Free~     Hospital with chronic kidney disease who have been established on regular thrice weekly~     haemodialysis treatments in a dialysis centre,to measure the changes in blood flow in the ear~     during haemodialysis.~   "
78011|NCT02545907|"~     This study evaluates the safety and efficacy of carfilzomib used in combination with~     thalidomide and dexamethasone in patients with relapsed AL amyloidosis. The trial begins with~     a dose escalation phase, in which the maximum tolerated and recommended dose will be~     determined. The trial will then open into an expansion phase in which the combination~     efficacy is assessed.~   "
78012|NCT02545894|"~     People with global aphasia (PwGA) post stroke have little to no meaningful communication~     abilities (ie limited comprehension, spoken language, reading and writing abilities).A~     proportion of PwGA will also have limited abilities to use any alternative means of~     communication e.g. gesture, pictures or computer devices. There is a suggestion in the~     literature that this is because of co-occurring cognitive deficits. The consequence is that~     these clients are unable to reliably communicate even their basic needs.This is commonly~     known as having no functional communication abilities. Such PwGA tend not to respond to~     standard speech and language therapy interventions.~      This research will investigate the effect of a new cognitive intervention designed to improve~     basic functional communication abilities. The treatment will be nonverbal and involve~     computer and paperbased tasks ordered hierarchically from basic to more complex tasks. Six to~     eight participants will take part. All their sessions will take place in their own home. For~     some this may be a care home. They will first complete a diagnostic communication assessment~     in order for baseline abilities to be established. Further formal language and cognitive~     assessments will be conducted over a period of 6 weeks. A relative/friend will complete a~     questionnaires about mood/communication. The PwGA will also be videoed interacting with the~     research student e.g. looking at a magazine, completing a jigsaw, answering questions and~     making choices non-verbally.~      The participants then receive the new intervention 3 times a week for 6 consecutive weeks.~     All intervention sessions will be videoed. Then participants will be reassessed over 2 weeks~     using the same assessments as prior to the intervention. The questionnaire with their~     relative/friend and videoed activity session will also be repeated. After a twelve week break~     the participant will be videoed interacting with the research student complete some of the~     assessments again and their relative will re-complete the questionnaires.~   "
78013|NCT02545881|"~     The purpose of this study is to develop, validate, and evaluate the correlation of novel~     magnetic resonance imaging (MRI) methods with prostate cancer aggressiveness and histological~     data obtained during prostatectomy.~   "
78014|NCT02545868|"~     This multicenter, randomized, open-label study will evaluate the immune response to vaccines~     (tetanus toxoid [TT]-containing adsorbed vaccine, 23-valent pneumococcal polysaccharide~     vaccine [23-PPV] either unboosted or boosted with 13-valent pneumococcal conjugate vaccine~     [13-PCV], influenza vaccine, keyhole limpet hemocyanin [KLH]) after administration of a dose~     of ocrelizumab (OCR) in participants with relapsing multiple sclerosis (RMS).~   "
78015|NCT02545855|"~     This is a prospective, randomized crossover study for evaluation of the efficacy and safety~     of long-term nocturnal high-flow nasal cannula therapy with the myAIRVO2® in stable COPD~     patients with stage 2-4 of the Global Initiative for Chronic Obstructive Lung Disease (GOLD)~     and hypercapnia who require home oxygen therapy (HOT). The total duration of subject~     participation will be 52 weeks, consisting of 12-week treatment period and 40-week~     continuation period. Subjects who satisfy all inclusion and exclusion criteria will be~     randomly assigned to one of two treatment arms, Arm A (week 1-6: the myAIRVO2® therapy plus~     HOT, week 7-12: HOT only) or Arm B (week 1-6: HOT only, week 7-12: the myAIRVO2® therapy plus~     HOT). All subjects will receive nocturnal high-flow nasal cannula therapy with the myAIRVO2®,~     in addition to their current HOT. After treatment period, the willing subjects can continue~     the myAIRVO2® therapy plus HOT for week 13-52 regardless of treatment arm assignment. The end~     of the study is defined as the treatment period or continuation period end date of the last~     participant, whichever is later. Subjects will primarily be assessed by the St. George's~     Respiratory Questionnaire for COPD Patients (SGRQ-C) at week 0, 6, 12, 24 and 52.~   "
78016|NCT02545842|"~     Primary Objective:~      To identify a best fasting plasma glucose (FPG) target for Chinese type 2 diabetes patients~     using insulin glargine which can provide the highest control rate of glycated hemoglobin~     (HbA1c) < 7%.~      Secondary Objectives:~      The control rate of HbA1c ≤6.5% achievement. The control rate of HbA1c <7.0% in patients~     achieving their FPG target. The percentage of HbA1c <7% without hypoglycemia. The percentage~     of patients achieving the FPG target without hypoglycemia. The percentage of patients~     achieving the FPG target and post prandial glucose (PPG) target (2-hour post breakfast <10~     mmol/L).~   "
78017|NCT02545829|"~     The purpose of this study is to investigate the bioequivalence after administration of~     HIP1302 and HGP1406 in healthy male volunteers.~   "
78018|NCT02545816|"~     After any acute brain injury, a primary pathophysiological response arises, enabling the~     brain to develop seizures and/or a status epilepticus (SE). These are frequently reported in~     patients admitted to the intensive care unit (ICU) with traumatic brain injury and brain~     injury caused by subarachnoid or intracerebral hemorrhage. Seizures can be presented without~     any clinical motor signs, which are then termed as nonconvulsive, and therefore remain~     frequently clinically unrecognized. As such, it is of great importance that these patients~     are diagnosed as early as possible since the increased metabolic demand and blood flow~     associated with an epileptic insult may further compromise the brain at risk. Thus far,~     continuous EEG (cEEG) is the only clinical instrument that is able to detect the development~     of early epileptic activity. Unfortunately, cEEG is not available in most ICUs and is~     labor-intensive, expensive and difficult to interpret for non-trained physicians. Therefore,~     a more simple and prognostic accurate EEG device is highly warranted to detect seizures in an~     early stage so that patients might benefit from a specific and early treatment. A validation~     study in comatose patients with an acute neurological insult will be conducted to provide~     evidence that simplified Bispectral Index EEG monitoring has the potential to detect~     epileptic activity as reliable as its gold standard, full EEG monitoring. Thereby, BIS EEG~     monitoring could possibly be used to facilitate the prognostication and management of~     epileptic seizures in this patient cohort which could eventually improve the clinical~     outcome.~   "
78019|NCT02545803|"~     Hypoxemia is commonly reported in patients admitted to the Intensive Care Unit (ICU) and may~     result from acute lung injury/acute respiratory distress syndrome (ALI/ARDS), sepsis, trauma~     and postoperative complications. In an attempt to preserve or increase the oxygenation,~     conventional mechanical ventilation is initiated in these patients. Unfortunately, patients~     frequently become refractory to standard ventilatory techniques and as such, gas exchange~     remains unaltered or becomes worse. High Frequency Percussive Ventilation (HFPV), on the~     other hand, is an advanced mode of ventilation which can be a salvage option in these patient~     cohorts as it has already been proven to improve gas exchange with success. The volumetric~     diffusive respirator (VDR-4; Percussionary, Corp., Sandpoint, ID) is the only commercially~     available system to deliver HFPV. This ventilator mechanically ventilates the lung by~     administering small successive subtidal volumes or percussions at unconventional high~     frequencies to reach an optimal diffusive oxygenation.~      Since it has been known that hypoxemia due to a reduced oxygenation results in secondary~     brain injury, it is conceivable that the cerebral tissue oxygenation might be impaired as~     well. It has been strongly suggested that a cerebral tissue oxygenation in the optimal range~     has an ameliorative influence on hypoxic events and in turn leads to a better clinical~     outcome. Thus far, no studies have been conducted to investigate if an improved oxygenation~     by means of a switch to HFPV automatically leads to an increment in the cerebral tissue~     oxygenation. With the use of Near-Infrared Spectroscopy (NIRS) technology, investigators will~     investigate whether this alternation of ventilation strategy is associated with a~     (beneficial) change of the cerebral tissue oxygenation.~   "
78020|NCT02545790|"~     This study is designed to learn more about children who have blockage of the left side of~     their heart. The goal is to determine how much the heart muscle has thickened before surgery~     and how it changes in the months after surgery. Investigators are also looking for blood~     tests that may help them predict which patients will have the most thickening pre-operatively~     and the best return towards normal after surgery. The findings of this study will help the~     investigators develop new tests to monitor affected patients and develop new therapies to~     help minimize heart thickening.~   "
78021|NCT02545777|"~     This research is based on spleen trapped by dampness and turbid which is the pathogenesis of~     gouty arthritis.It uses effective prescription of Endocrinology of Dongzhimen Hospital.In~     this study, the investigators use multi-center randomized parallel controlled clinical~     trials.The treatment groups are afforded oral traditional Chinese medicine~     decoction-tonifying spleen and descending the turbid decoction as well as soaking and wet~     wrapping.The control groups are afforded diclofenac sodium enteric-coated tablets as a~     positive control drug.The outcome is evaluated by condition of symptoms remission,pain relief~     time, recurrence rate and laboratory index to determine the efficacy of internal and external~     treatment.And the research will provide optimized diagnosis and treatment program. The~     investigators hope this research will also get tonifying spleen and descending the turbid~     internal and external treatment for gouty arthritis effective clinical treatment.~   "
78022|NCT02545764|"~     Childhood obesity is one of the most critical and accelerating health challenges throughout~     the world. It is a major risk factor for developing varus/valgus misalignments of the knee~     joint. The combination of misalignment at the knee and excess body mass may result in~     increased joint stress and damage to articular cartilage. A training programme, which aims at~     developing a more neutral alignment of the trunk and lower limbs during movement tasks may be~     able to reduce knee loading during locomotion. Despite the large number of guidelines for~     muscle strength training and neuromuscular exercises that exists, most are not specifically~     designed to target the obese children and adolescent demographic.~      The purpose of this study is to evaluate a training programme which combines strength and~     neuromuscular exercises specifically designed to the needs and limitations of obese children~     and adolescents and analyse the effects of the training programme from a biomechanical and~     clinical point of view.~   "
78023|NCT02545751|"~     Patients with esophageal cancer that had metastatic lesions after been treated with~     definitive surgery or chemoradiotherapy are being asked to participate in this study.~        1. To observe immunity-mediated tumor response after Stereotactic Body Radiation~          Therapy(SBRT) of a metastatic site in metastatic esophageal cancer patients.~        2. To induce the efficacy (effectiveness) of a new combination of therapy, SBRT and~          thymalfasin for heavily pretreated, metastatic esophageal cancer patients; This study~          will help find out what effects (good or bad) the combination of radiotherapy and~          thymalfasin has on metastatic esophageal cancer.~   "
78024|NCT02545738|"~     The purpose of the study is to determine the effect of Liraglutide on albuminuria in type 2~     diabetes.~   "
78039|NCT02545543|"~     This is a study to assess the immune (antibody) response and safety of a Seqirus split~     virion, inactivated Quadrivalent Influenza Vaccine (Seqirus QIV), in comparison with a US~     licensed 2015/2016 Quadrivalent Influenza Vaccine (comparator QIV) in a healthy pediatric~     population 5 through 17 years of age.~   "
78025|NCT02545725|"~     This study is collecting data on quality of life, (care)needs and socio-economic factors in~     colorectal (ex-)cancer patients via a written questionnaire completed by the patient~     him/herself. The collected data will be linked with the patient- and tumour characteristics~     available in the database of the Belgian Cancer Registry and with the facturation data~     supplying information about diagnostic techniques and performed treatments (available via the~     insurance companies).~      Based on the selection criteria, 1220 patients were finally selected from the database of the~     Belgian Cancer Registry. These patients received an invitation letter by regular mail, a~     detailed questionnaire and an informed consent.~      The questionnaire contains topics as sociodemographic, life style, comorbidity, satisfaction~     with the provided information, care needs, quality of life, anxiety and depression, financial~     situation etc.~      The patients were asked to complete the questionnaire and send it back, together with the~     signed informed consent, to the study-collaborators.~      After 2-4 weeks, a reminder was sent. At that time, a reply card was added. If a patient~     doesn't want to participate in this study, a reason can be mentioned on the reply card.~      The collected data are linked with the clinical data. The dataset will be coded before~     analyses will start.~   "
78026|NCT02545712|"~     The purpose of this study is to explore the quantity of excipient exposure in neonatal and~     young pediatric patients in a Danish Hospital. The focus will be on the preservatives~     ethanol, propyl glycol, benzyl alcohol, methyl-p-hydroxybenzoate and~     propanyl-p-hydroxybenzoate and the artificial sweeteners acesulfam potassium, aspartame,~     glycerol and sorbitol.~   "
78027|NCT02545699|"~     The purpose of this study is to compare the adenoma detection rate (ADR) of the G-EYE™~     colonoscopy with that of standard colonoscopy.~   "
78028|NCT02545686|"~     CPAP will be applied to normal volunteers inorder to understand CPAP's effects on breathing~     and chest wall motion.~   "
78029|NCT02545673|"~     The purpose of this study is to evaluate the effectiveness of a linkage to care intervention~     at achieving HIV viral suppression and intermediate outcomes of linkage/time to care, time to~     /receipt of opportunistic infection prophylaxis, and antiretroviral therapy (ART) among~     people testing HIV positive during home-based HIV counseling and testing (HBHCT) in rural~     Uganda.~   "
78030|NCT02545660|"~     During orthodontic treatment bacterial plaque readily accumulates on the teeth. This is~     because food easily accumulates around the braces and it is more difficult to clean when the~     braces are in place. The plaque accumulation can lead to demineralisation (white spots)~     developing on the teeth. This is the start of decay and can lead to permanent marks and~     fillings being required.Prior to the start of orthodontic treatment adequate oral hygiene is~     necessary.~      During orthodontic treatment, it is important that patients have an excellent level of oral~     hygiene to prevent plaque accumulating and demineralisation occurring. However, adequate~     tooth brushing can be difficult to perform as the bacterial plaque is not easily visible.~     Thus patients may not be able to see which areas need better tooth brushing.~      QLFD(Quantitative Light Induced Fluorescence Digital) is a noninvasive method that uses~     fluorescent light to illuminate the oral bacteria in plaque that are responsible for~     demineralisation. The purpose of this study is to use the QLFD camera to assess its ability~     to measure plaque accumulation and demineralisation before the start of orthodontic~     treatment. The study will also assess the QLFD camera as a tool to improve oral hygiene.~   "
78031|NCT02545647|"~     A Roux-en-Y Gastric Bypass (RYGB) is on the long term not always successful in every patient~     because weight regain can occur. An intervention to prevent weight regain in the future is to~     place a silicone band (non-adjustable) around the pouch of the RYGB (Banded-RYGB: BRYGB)~     which increases weight loss and decreases weight regain on the longer term. The question is~     whether primary application of a banded bypass gives a greater weight loss and / or prevent~     weight regain in the future versus a standard RYGB.~   "
78032|NCT02545634|"~     The study will examine the effect of a probiotic supplement (Lactobacillus helveticus R0052~     and Bifidobacterium Longum R0175) dissolved in a dairy product such as milk or ice-cream on~     symptoms of ADHD and anxiety in children. The main goal is to determine if probiotics might~     be useful as a treatment for anxiety and ADHD symptoms in children. A second goal is to~     examine the effects of probiotics on saliva cortisol levels. Finally, the investigators are~     also interested in the effects of the probiotics on children's digestive health.~   "
78033|NCT02545621|"~     RAGE (the receptor for advanced glycation end-products) is a marker of alveolar type I cell~     injury and a pivotal mediator of acute inflammation and innate immunity. RAGE pathway is~     highly regulated; the interaction of the transmembrane receptor with its various ligands~     (e.g. HMGB1, S100A12) ultimately leads to NF-kB activation and RAGE upregulation itself, but~     precise RAGE functions and intracellular pathways remain underexplored. During ARDS, monocyte~     and macrophage activation could modulate alveolar inflammation and repair.~      As RAGE is also expressed at the surface of monocytes/macrophages, we hypothesize that~     alveolar monocyte/macrophage activation may be mediated through a RAGE-TXNIP (thioredoxin~     interacting protein)-NLRP3/inflammasome intracellular pathway. The purpose of this~     observational prospective study is to compare alveolar monocyte/macrophage activation~     profiles (as assessed by Fluorescence-Activated Cell Sorting (FACS)) in mechanically~     ventilated patients with or without ARDS.~   "
78034|NCT02545608|"~     The purpose of this study is to determine the safety and efficacy of using Restylane Vital~     for skin rejuvenation of the dorsal hands. Assessment of improvement of skin structure will~     be done by a blinded evaluator.~   "
78035|NCT02545595|"~     This randomized double blind clinical trial focuses on patients with Body Masse Index ≥ 40~     kg/m2, undergoing scheduled surgery. Neuromuscular transmission monitoring at the adductor is~     performed using. Anaesthesia is induced with anaesthesic and maintained with curare. At the~     end of the procedure, patients with profound neuromuscular blockade receive either 1 mg/kg, 2~     mg/kg or 4 mg/kg Sugammadex based on ideal body weight. A complete reversal failure is~     defined by a Train Of Four ratio < 0.9 within 10 min after administration of Sugammadex or if~     recurarization occurs within 15 min after complete reversal success.~   "
78036|NCT02545582|"~     This registry will observe patients with symptomatic heart failure with implantable vagus~     nerve stimulation to provide insights into safety and efficacy during clinical routine.~   "
78037|NCT02545569|"~     The purpose of this evaluation is to receive the greatest benefit of new custom made hearing~     product technology and shell modification for the end customer and to continual improve the~     custom made hearing products.~   "
78043|NCT02545491|"~     Background: Responsive stimulation and/or enhanced nutrition interventions delivered to~     children through health programs shows improved cognitive, language, and motor, and the~     social-emotional status. This could benefit young children in Lebanon and worldwide to~     improve their developmental potential.~      Aim: This study aims to implement Care for Child Development (CCD) intervention for children~     aged 0-3 years within a supportive environment in Day Care Centers and to investigate its~     effectiveness on early child development.~      Methodology: CCD program will be implemented in 10 randomly selected daycare centers in~     Lebanon where three providers in each center will be trained (CCD-group). Another group of 10~     day care centers will serve as controls (WV-group). 228 Children in each group will receive~     either early stimulation based on CCD and education from the World Vision Infant and Young~     Child Feeding (WV-IYCF) project (CCD-group) or education from the WV-IYCF project (WV-group).~     Caregivers' knowledge and behaviors will be assessed before and after the intervention using~     a predetermined questionnaire and behavioral checklist. Early child development will be~     assessed using Ages and Stages Questionnaire-3 (ASQ-3) and Bayley Scale for infant~     Development (BSID-III).~      Expected Outcome: Implementation of CCD program in day care centers will be feasible and will~     lead to enhanced early child development. This study will serve as a prototype for program~     implementation throughout the country and the region.~   "
78044|NCT02545478|"~     The purpose of this investigation is to evaluate how early biomarkers of infection and~     inflammation perform in identifying patients at risk for poor outcome in sepsis and septic~     shock.~   "
78045|NCT02545465|"~     The aim of this study is to understand the treatment patterns in patients with Pulmonary~     Arterial Hypertension (PAH) or Chronic Thromboembolic Pulmonary Hypertension (CTEPH) during a~     switch of treatment to Adempas in real-life clinical practice.~      In addition, this study will describe patient demographics and reason for switching~   "
78046|NCT02545452|"~     To investigate the pharmacokinetic effect of a vaginally administered antimycotic~     (miconazole), antibiotic (clindamycin), spermicide (nonoxynol-9) or the concomitant use of~     tampons during the use of an intravaginal ring releasing anastrozole and levonorgestrel~   "
78047|NCT02545439|"~     This study will evaluate the impact of CYP3A4 induction on the single-dose pharmacokinetics~     of ALKS 5461.~   "
78048|NCT02545426|"~     Chronic kidney disease (CKD) is linked to elevated mortality rate, and cardiovascular disease~     is the main cause related to this outcome. The cardiovascular mortality among patients on~     conventional hemodialysis (CHD) is high, achieving up to 30 times more risk of death when~     comparing to individuals of same age on general population. Congestive heart failure can~     develop in 25% to 50% of patients, leading to a worse prognosis. CKD patients present~     anatomic and functional abnormalities on peripheral bed vases and also cardiovascular~     abnormalities that can cause myocardial ischemia. This last usually is transitory and lead to~     left ventricular dysfunction that can persist even after the end of dialysis session despite~     normal coronary perfusion. The prolonged dysfunction is called myocardial stunning (MS).~     Patients on CHD are subject to hemodynamic instability, myocardial ischemia and development~     of regional abnormalities of myocardial wall (ARPM´s). MS induced by intradialytic ischemia~     is a complication that can be minimized by applying techniques associated to more stability~     during the CHD, as cool dialysate or increasing the length of the therapy. The goal of the~     present study is to evaluate the behavior of cardiovascular system (trough hemodynamic~     performance during CHD, accessing MS by echocardiography technique, and biomarkers associated~     to MS). Finally, the investigators aimed to investigate the role of two different dialysate~     calcium concentration (2,5 and 3,5 mEq/l) in the genesis of MS during CHD. The elucidation of~     pathogenesis of MS during CHD might help us modified hemodialysis technique in order to~     prevent MS, and reduce the high cardiovascular mortality among CKD patients.~   "
78049|NCT02545413|"~     Irritable bowel syndrome (IBS) is the most common functional GI disorder in which abdominal~     pain and/or discomfort is associated with changes in bowel habit, and with features of~     disordered defecation. IBS affects 10-20% of the population and causes a marked reduction of~     quality of life in affected individuals.The high prevalence of IBS is accompanied by large~     societal economic burdens and negative effects on the quality of life in affected patients.~     It is divided into 3 types IBS-D diarrhea predominant, IBS-C constipation predominant, IBS-M~     mixed sub type.~   "
78050|NCT02545400|"~     This study aims to assess the frequency and severity of adverse events during Hepatitis C~     therapy with or without first generation protease inhibitors.~   "
78051|NCT02545387|"~     Patients with hepatitis C show impaired neutrophil function. It is not known whether this is~     a direct of an indirect phenomenon. Using bone marrow biopsies from patients with hepatitis C~     it is possible to see whether neutrophil granulocyte progenitors are already infected with~     hepatitis C.~   "
78052|NCT02545374|"~     Estimate in 6 months the impact of the telemedicine on the cure rate of the chronic wounds~     compared with the usual care(with or without CICAT-LR Network).~   "
78053|NCT02545361|"~     The purpose of this study is to evaluate the safety and to determine the Dose Limiting~     Toxicity (DLT) and the Maximal Tolerated Dose (MTD) of KAHR-102.~   "
78054|NCT02545348|"~     This is an obstervationnal study, to evaluate the good clinical practice of the use of the~     sentinel node biospy in early stage endometrial cancer. The collaborating centres with the~     OncoGynecology board of the King Albert II Institute of the Clinique Universitaire Saint-Luc~     will also particpate to the trial.~      Sentinel node biospy is not yet validated for endometrial cancer, even if lots of leading~     team in the world published very good result and that the first prospectives trials are~     already published with also excellents results. The investigators decided then to include~     this practice in their institutional guideslines and also to registred the procedure.~   "
78055|NCT02545335|"~     The aim of this study is to characterize neutrophil function in patients undergoing chronic~     hepatitis C triple therapy with protease inhibitors in comparison to dual therapy with~     peginterferon and ribavirin and with interferon free treatment regimen to thereby elucidate~     the possible mechanisms of protease-inhibitor associated infections.~   "
78097|NCT02544789|"~     Outcomes for children with relapsed/refractory (R/R) acute lymphoblastic leukemia (ALL) are~     dismal. Therefore, the investigators performed this multicenter, phase II study to evaluate~     the efficacy and , safety and pharmacokinetic of clofarabine in Chinese pediatric patients~     with R/R ALL~   "
78056|NCT02545322|"~     Aim of this study is the clinical evaluation of an image-guided adaptive radiotherapy~     concept. This involves the adaption of the radiotherapy treatment plan according to changes~     in tissues and variations in patients position and posture during a radiotherapy treatment~     course, based on repeat CT scans.~      It is investigated, if dosimetric improvements can be achieved using this approach and if the~     method using the software-package ReDeform can be implemented in clinical Routine.~   "
78057|NCT02545309|"~     SSC-CIP is increasing in patients after critical illness. Pathogenesis is still largely~     unclear. The investigators hypothesize that genetic variants of biliary transporter genes are~     frequent in patients with SSC-CIP. In approximately 140 patients and controls the rate of~     genetic variants in biliary transporter genes, gut permeability and gut microbiome as well as~     bone health will be studied.~   "
78058|NCT02545296|"~     HIV Point-of-Care tests in Babies Study (BABY) - Operational evaluation of HIV Point-of-Care~     tests for very early infant HIV diagnostics in infants born to HIV infected mothers in Mbeya,~     Tanzania.~   "
78059|NCT02545283|"~     This is a multicenter, double-blind, randomized, placebo-controlled study designed to compare~     overall survival in participants with relapsed or refractory AML treated with idasanutlin in~     combination with cytarabine versus participants treated with placebo and cytarabine.~     Participants will receive induction treatment with idasanutlin/placebo and cytarabine (Cycle~     1). Responding participants may continue to receive a maximum of further two cycles of~     consolidation (Cycle 2 and Cycle 3). Complete remission (CR), CR with incomplete platelet~     count recovery (CRp), overall remission rate (ORR), event-free survival (EFS), leukemia-free~     survival (LFS) and percentage of participants with an allogeneic hematopoietic stem cell~     transplant (HSCT) will also be compared between treatment arms. This study will include~     participants with and without TP53 wild type (TP53 WT) mutations.~   "
78060|NCT02545270|"~     It is of great importance to obtain optimal surgical conditions for the surgeon in order to~     increase patient safety. The effect of different interventions on surgical conditions has~     been assessed by various surgeon-assessed rating scales. A 5-point surgical rating scale has~     previously been tested in a proof-of-concept trial - but not validated - during radical~     retropubic prostatectomy by asking different surgeons to evaluate the surgical workspace~     using video sequences.~      In an ongoing study (The Hernia Study, Trial registration NCT02247466) performed by~     investigators group, investigators are using a 5-point scale to rate the surgical workspace~     during laparoscopic ventral herniotomy with or without neuromuscular blockade. This scale is~     based on previously used scales by already published studies and has a description connected~     to each point. To the authors' knowledge the scale has never been validated in a laparoscopic~     setting, where the intra-abdominal pressure during pneumoperitoneum can have a great~     influence on visualization. In fact, to investigators knowledge, no validated~     surgeon-assessed rating scale regarding the surgical workspace during laparoscopic surgery~     does exists.~      Purpose:~      Primary aim:~      To validate a 5-point rating scale by investigating the inter-rater agreement of evaluations~     of the surgical workspace at different intra-abdominal pressures. Using intra-abdominal video~     recordings.~      Secondary aims:~      To validate a 10-point rating scale by investigating the inter-rater agreement of evaluations~     of the surgical workspace at different intra-abdominal pressures.~      To test the agreement between the two rating scales. To assess which of the two rating scales~     has the highest inter-rater agreement To assess the intra-rater agreement of both rating~     scales.~      Hypothesis:~      Investigators hypothesize that the 5-point rating scale has an intra-class correlation~     coefficient (ICC) > 0.6., validated by video-sequences obtained during laparoscopic surgery.~   "
78061|NCT02545257|"~     The objective of this randomized controlled trial is to develop a coordinated,~     multiprofessional medication management model for home-dwelling aged in primary care and to~     study the effectiveness of this model. The main hypothesis is that the new model helps to~     identify aged people having potential risks with their medications and thus allows solving~     these risks.~   "
78062|NCT02545244|"~     The study was conducted to measure the effectiveness of Black Tea in reducing the deposits on~     teeth. It also compares the effect between use of black tea mouthwash and green tea mouthwash~     to that of chlorhexidine in reducing plaque deposition on teeth in a two weeks long clinical~     trial among adults of 18-40 years of age.~   "
78063|NCT02545231|"~     To compare low dose (1mg) pitavastatin and high dose (4mg) pitavastatin on neointimal~     hyperplasia and atherosclerosis progression by using optical coherence tomography (OCT) and~     near-infrared spectroscopy (NIRS) at 12 months follow-up and on clinical adverse~     cardiovascular events during 3-year follow-up.~   "
78064|NCT02545218|"~     The perineal body is commonly injured during labor. It is possible to perform a secondary~     repair, a perineorraphy, which aims to reduce the symptomatology after an improperly healed~     perineal tear. The aim of the randomized trial is to evaluate the results of such an~     operation compared with conservative treatment.~   "
78065|NCT02545205|"~     The overall purpose of this project is to establish the added value of training with the~     Hybrid Assistive Limb (HAL) exoskeleton system as part of regular rehabilitation intervention~     programs after stroke.~      The aim of this study is to explore if HAL training when combined with conventional training~     in the subacute stage after stroke may accelerate the recovery of independence in walking~     when compared to conventional training only and if recovery is related to stroke~     lateralization?~   "
78066|NCT02545192|"~     The investigators propose to make the first observations of LFMS treating a population of~     subjects with PTSD. A positive outcome for this study could translate directly into a new~     treatment modality for symptoms of PTSD in both acute and chronic situations. The~     investigator's goal is to demonstrate the safety and efficacy of LFMS as a possible aid in~     the treatment of PTSD.~   "
78067|NCT02545179|"~     Purpose:Effect of web-based daily care training on the quality of life of caregivers of~     children with cerebral palsy.~      study design: Single-blind clinical trial. study population: Caregivers of children with~     cerebral palsy. Inclusion criteria: caregiver -Mother of a child with cerebral palsy who~     spent most time on child care- Children with cerebral palsy aged 4 to 12 years old living in~     Alborz province that clinical diagnosis of cerebral palsy registered in their clinical~     records. Moderate and severe cerebral palsy (gross motor function levels 3 to 5). caregiver~     have facilities and basic knowledge of using Internet (Declared access to the Internet at~     least one hour a week). exclusion criteria: taking care of two or more children with~     disability. participated in previous face to face training programs.~      Sample size: 100. Intervention: Web-based daily care training. intervention time: 12-week.~     Outcome of the study: the quality of life of caregivers~   "
78068|NCT02545166|"~     This study will validate the sensitivity of a purine biosensor (SMARTChip) in detecting acute~     cerebral ischaemia in a group of patients undergoing elective carotid endarterectomy. The~     study will also investigate whether blood purine levels are indicative of future risk of~     stroke by comparing pre-operative blood purine levels in carotid endarterectomy patients~     (high risk group) and blood purine levels in a group of age and sex-matched controls.~   "
78069|NCT02545153|"~     Bile leak reduction from the common bile duct, as a result of glue appliance after~     cholangiotomy.~   "
78072|NCT02545114|"~     Hyponatremia occurs frequently in patients with acute brain injury in the days to weeks~     following injury, and may contribute to adverse outcome. In addition, hyponatremia can~     aggravate neurologic dysfunction, complicate neurological assessments, and contribute to~     neurologic symptoms such as gait dysfunction that can impair efforts at mobilization and~     rehabilitation. Strict normonatremia (serum Na levels between 135 and 145 meq/dl) is the goal~     in most patients with acute brain injury. SIADH is the most frequent cause of hyponatremia in~     patients with neurological injury; however, treatment with fluid restriction is often~     difficult or contra-indicated, for example in patients with subarachnoid hemorrhage (SAH)~     where intravascular hypovolemia can trigger vasospasms. The aim of this project is to test~     Tolvaptan, an ADH antagonist, as a treatment in selected patients with acute brain injury who~     have developed SIADH.~   "
78073|NCT02545101|"~     This is a retrospective chart review non-interventional study designed to collect real world~     data on the use and outcomes of tolvaptan for the treatment of patients with hyponatraemia~     secondary to syndrome of inappropriate antidiuretic hormone (SIADH) secretion.~   "
78074|NCT02545088|"~     The overall purpose of this project is to establish the added value of training with the~     Hybrid Assistive Limb (HAL) exoskeleton system as part of regular rehabilitation intervention~     programs after stroke.~      The main specific aims are:~      (i) to compare potential effects on functioning and disability of gait and mobility training~     long-term after stroke by comparing A) HAL-training combined with conventional rehabilitation~     interventions to B) conventional rehabilitation interventions without HAL and to C) no~     intervention.~   "
78075|NCT02545075|"~     The purpose of this study is to determine whether Ipilimumab will extend the life of chinese~     patients with Chemotherapy Naive Stage IV Melanoma more than Dacarbazine as well as to~     examine safety in this patient population.~   "
78076|NCT02545062|"~     T2D and cognitive impairment are two of the most common chronic condition found in persons 60~     years and older. Diabetes type 2 increases with age and studies suggest that the diabetes is~     one of the risk factor for cognitive impairment and dementia.~      Although there is much recent research showing that diabetics at every age have more~     cognitive impairment and dementia than non-diabetics, relatively little attention has been~     paid to the implications of this complication in the management of T2D in terms of screening,~     prevention, education and treatment adherence.~      There are now guidelines for periodic evaluation of patients with diabetes as early detection~     of complications of the disease, but so far there are no similar assessment and monitoring of~     cognitive function.~      In this study the investigators examine cognitive function in young diabetic patients (from~     20 to 55) using the MoCa test, that allows detection of mild cognitive impairment, and may be~     carried out during a visit, an annual advisory diabetes clinic.~   "
78077|NCT02545049|"~     The purpose of this study is to evaluate whether oral finerenone (study drug), in addition to~     standard daily therapy, is effective and safe in treating patients with type 2 diabetes~     mellitus and diabetic kidney disease, when compared to a placebo.~   "
78078|NCT02545036|"~     The annual report of USRDS shows than Taiwan has the highest prevalence of~     end-stage-renal-disease globally resulted in high prevalence dialysis rate. The major factors~     associated with chronic renal failure are age, diabetes, hypertension, chronic~     glomerulonephritis, metabolic syndrome, smoke, hepatitis C, painkiller and herbals. Chronic~     kidney disease may lead to various metabolic, cardiovascular and neurological diseases. And~     these possible prognostic factors associating with the disease progression and ultimately~     increase the morbidity and mortality. End-stage renal failure is an irreversible course often~     with clinical manifestations of edema, fatigue, anemia and uremic pruritus. Patients often~     use Chinese medicine or acupuncture to help them to ease the symptom.~      The aim of this study is to investigate the efficacy of combined Western medicine and~     traditional Chinese medicine daycare model for chronic kidney disease patients. The study~     approach to investigate whether combination of Western medicine and traditional Chinese~     medicine daycare model can improve the clinical symptoms and quality of life as well as the~     laboratory biochemistries data.~   "
78079|NCT02545023|"~     This phase I/II research trial studies supportive care questionnaires in gathering data on~     unmet needs and health-related quality of life in Latina breast cancer survivors after~     surgery, chemotherapy, or radiation therapy. Questionnaires that address unmet supportive~     care needs and health-related quality of life of breast cancer survivors may help doctors~     learn about barriers to cancer care that are linked to language, acculturation, knowledge~     about diagnosis and care, and financial concerns. Learning about unmet needs of breast cancer~     patients may help increase quality of life and decrease healthcare utilization and costs.~   "
78080|NCT02545010|"~     Background: Epithelial Ovarian Cancer is the most lethal amongst the gynecologic malignancies~     and is the fifth leading cause of cancer death in women in the United States.1 Despite~     initial high response rates, 50% to 75% of women who present with advanced disease suffer~     relapse and require re treatment2.The optimal treatment for platinum resistant ovarian cancer~     remains hotly debated. Combination chemotherapy is not favored due to its increased toxicity~     and lack of convincing benefit when compared to single agent chemotherapy.3,4 Recently, the~     addition of bevacizumab to single agent chemotherapy in the AURELIA study improved~     progression free survival (PFS) from 3.4 months to 6.7 months. Response rates were also~     improved from 11.8% versus 27.3% (p= 0 .001).9 Aim: To determine the maximal tolerated dose~     (MTD) of weekly paclitaxel in combination with LDWART. The recommended phase II dose (RP2D)~     will be based on the MTD in this Phase I study. Method: This study is designed as a~     prospective, single arm phase I study with 3+3 with dose de-escalation and cohort expansion.~     All patients will receive weekly paclitaxel at a pre specified dose of 80 mg/m2, 70 mg/m2,~     60mg/m2 or 50 mg/m2 via intravenous infusion according to institution specific standard~     practices. Cycles of chemotherapy will be administered weekly without interruption on Days~     1,8,15,22,29,36 for a total of 6 weekly cycles in combination with LDWART(Fig.1). LDWART will~     be given at 60 cGy fractions, twice daily for two days, with a minimum of 4 hours inter~     fraction interval, starting on day 1 of each cycle of weekly paclitaxel for 6 weeks.(Fig.1).~     Importance of proposed research: The combination of a LDWART with weekly paclitaxel may~     improve the efficacy of the current standard weekly paclitaxel in platinum resistant ovarian~     cancer patients. Potential benefits and risks: The combination may improve treatment~     response. Adding LDWART may increase treatment risks, but these will be monitored closely.~   "
78098|NCT02544776|"~     On the basis of the current study, amlodipine seems to be a promising drug on improving~     uterine, ovarian blood flow, size of pre-ovulatory follicle, midluteal progesterone level and~     pregnancy outcome in patients with pco.~   "
78099|NCT02544763|"~     This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The~     blinded phase only will be described in this record. Participants will receive 1 of 2 doses~     of GWP42003-P or matching placebo. The primary clinical hypothesis is that there will be a~     difference between GWP42003-P and placebo in their effect on seizure frequency.~   "
78081|NCT02544997|"~     Metastatic breast cancer (MBC) is an incurable disease and is needed to improve effective~     therapeutic strategies including targeted agents.~      Poziotinib is a panHER tyrosin kinase inhibitor (TKI) that showed stable activity with~     feasible toxicity for MBC patients as a salvage treatment strategy after failure of~     anthracycline and taxane in phase I trial. Poziotinib has rational benefit compared with~     other salvage agents, especially for patients with HER2 overexpression breast cancers.~     Additionally, a recent report showed that possible rational background for patients with HER2~     mutation-positive breast cancers.~      Based on this rationale, the investigators are to conduct phase II single-arm study of~     poziotinib for patients with MBC who showed refractoriness to conventional treatments as~     salvage treatment.~   "
78082|NCT02544984|"~     The purpose of this study is to determine if the prophylactic use of azithromycin will reduce~     the total number of days when unscheduled treatment is given outside of the home in a clinic,~     urgent care, emergency room or hospital setting between the respiratory illness season months~     (October 1-March 31) and subsequent 2 month follow-up (April and May)~   "
78083|NCT02544971|"~     Post-traumatic stress disorder (PTSD) is a common debilitating disorder that affects many~     individuals exposed to aversive events. The severity of PTSD symptoms is positively~     correlated with amygdala activation. More severe PTSD symptoms following exposure to~     stressful events, are associated with amygdala hyper-responsivity prior to exposure. A~     possible intervention for PTSD is Neurofeedback (NF) - a treatment method based on learned~     self-modulation of neural activity in response to feedback of neural signal. Previous work in~     our lab established a NF training procedure that utilizes the temporal abilities of EEG with~     the spatial advantages of fMRI. Further work based on this method using the amygdala BOLD~     signal (EEG-finger-print, EFP) has demonstrated a potential for improving the ability to~     self-regulate amygdala activity and to improve emotional regulation in a healthy population.~     The current study aims to investigate the potential of this method as a therapeutic~     intervention for PTSD.~   "
78084|NCT02544958|"~     To investigate the efficacy of Erbium:Yttrium aluminum garnet laser (Er:YAG) in the treatment~     of enlarged pores.~   "
78085|NCT02544945|"~     This is a cohort study of 16 women undergoing post-mastectomy chest wall radiotherapy for~     breast cancer comparing two ways of modifying the radiation beam with bolus (a 5mm rubber~     substance placed on the skin to modify the radiation beam). The hypothesis is that 3D printed~     bolus will conform more closely to the chest wall than standard 5mm-thick standard bolus and~     thus lead to less chance of underdose or overdose of the skin. Each patient will receive the~     standard dose of radiotherapy, but half the treatments will use standard bolus and half the~     treatments will 3D printed bolus (ie each patient will act as is their own control). The~     primary outcome is the comparison of the amount of air under the bolus for each technique.~     Secondary outcome is the amount of time it takes to set up the patient for radiotherapy.~   "
78086|NCT02544932|"~     Atrial fibrillation (AF) has been known to have several pathophysiologic mechanisms including~     endothelial dysfunction of heart and vessel. This study was designed to determine the~     efficacy of NOAC therapy in the prevention of endothelial dysfunction and progression of~     atherosclerosis of AF subjects.~   "
78087|NCT02544919|"~     To study the impact of pretreatment of living donor liver transplantation recipients with~     SMOF lipid on the incidence and severity of post-transplantation neurological complications~     in patients receiving tacrolimus based immunosuppression protocol~   "
78088|NCT02544906|"~     The use of propofol or dexmedetomedine for prevention of sevofurane emergence agitation in~     LDLT recipients~   "
78089|NCT02544893|"~     we aimed postoperative analgesic effects of using bupivacaine alone or added dexmedetomidine~     for ultrasound guided thoracic paravertebral block in thoracotomy~   "
78090|NCT02544880|"~     The investigators hypothesize that Tadalafil treatment, by lowering Myeloid Derived~     Suppressor Cells (MDSCs) and regulatory T cells (Tregs), can prime an antitumor immune~     response and promote a permissive environment that should increase the efficacy of anti-tumor~     vaccine in a setting of minimal residual disease.~   "
78091|NCT02544867|"~     An emerging body of epidemiological evidence suggests that various forms of sedentary~     behavior, including TV viewing, occupational sitting, and total daily sitting, may be~     associated with all-cause and cardiovascular mortality, overweight and obesity, type 2~     diabetes, depression and psychological well-being. Importantly, many of these associations~     were independent of participation in moderate to vigorous intensity physical activity. We~     propose a pilot study to assess the feasibility, acceptability and preliminary efficacy of~     two interventions targeting sedentary behavior. Since it is currently unknown what component~     of sedentary behavior exposure presents the greatest risk to health, we propose separate~     interventions to reduce overall sedentary time and to promote breaks in sedentary time.~   "
78092|NCT02544854|"~     By measuring plasmatic concentration of propofol at different intervals during surgery of~     children aged 1 to 12 years old and measuring Bispectral Index (BIS) as a surrogate for~     cerebral activity, the investigators aim to create a pharmacokinetic/pharmacodynamic model of~     propofol for children.~   "
78093|NCT02544841|"~     The purpose of the study is to determine the impact of the offer to participate in Safer Sex~     Intervention (SSI) (treatment) relative to the offer to participate in Female Sexual Health~     (control) on three self-reported sexual behaviors (condom use, other contraceptive use, and~     frequency of sex) six months after the end of treatment.~   "
78094|NCT02544828|"~     The objective of the present study is to determine the impact of intraoperative IV-iron~     supplementation on postoperative oxygenation profile by comparing the postoperative PaO2/FiO2~     ratio with or without IV-iron supplementation in old patients undergoing elective uni-limb~     arthroplasty surgery.~   "
78095|NCT02544815|"~     AHFS management is challenging and most of the used drugs has failed to decrease~     post-discharge mortality and readmission rates which represent the most important goal in~     AHFS.~      Digoxin processes many characteristics of a beneficial drug for heart failure, however recent~     publications has rose concerns about its safety profile and therefore decreasing its use.~      Whether digoxin is efficient and safe in short term treatment of acute heart failure is a~     question that should be studied.~   "
78096|NCT02544802|"~     The purpose of this study is to evaluate the safety and preliminary efficacy of autologous~     adipose-derived mesenchymal stem cells (ADMSCs) treatment for patients with primary~     osteoarthritis knee. Three intra-articular injections of autologous ADMSCs will be performed~     to subjects at a weekly interval.~   "
78100|NCT02544750|"~     This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The~     open-label extension phase only will be described in this record. All participants will~     receive the same dose of GWP42003-P. However, investigators may subsequently decrease or~     increase the participant's dose until the optimal dose is found.~   "
78101|NCT02544737|"~     Patients with esophageal cancer that had metastatic lesions after been treated with surgery~     or definitive chemoradiotherapy are being asked to participate in this study.~      Apatinib is a small-molecule vascular endothelial growth factors receptor (VEGFR) tyrosine~     kinase inhibitor, similar to vatalanib (PTK787), but with a binding affinity 10 times that of~     vatalanib or sorafenib.~      The purpose of this study is to determine what effects apatinib has on metastatic esophageal~     cancer. These effects include whether apatinib could shrink the tumor or slow down its growth~     and what side effects apatinib will have on the tumor.~   "
78102|NCT02544724|"~     NM-IL-12 is being evaluated as an immunotherapeutic with concomitant hematopoietic~     regenerating properties for treatment of relapsed/refractory DLBCL, an aggressive type of~     B-cell non-Hodgkin's lymphoma (NHL). Determination of the maximum tolerated dose (MTD) for~     NM-IL-12 is not planned in this study, rather, a pre-defined dose of 150 ng/kg will be~     explored; this dose is based on two safety and tolerability studies of NM-IL-12 in healthy~     volunteers.~   "
78103|NCT02544711|"~     Primitive malignant bone tumor or mixt tumor (compounded of soft tissues and bone) is a rare~     pathology particularly within the pelvis, the sacrum or the hip (between 25 and 80 new cases~     in France per year).~      The reference treatment is a surgical en bloc resection associated or not to a medical~     treatment. This surgery remains highly challenging because of the complex three-dimensional~     geometry of the pelvic bone and the proximity of important organs and neurovascular~     structures. The local recurrence rate is significantly increased when the resection does not~     respect a safe tissues margin (R0 margin).~      A new technology has been developed and used in different reference sites the Patient~     Specific Instrument (PSI), manufactured by 3D-Side. The PSI allows for a more secure and~     reliable surgical gesture, leading to more frequent R0 margins.~      The main objective of this study is to compare the efficiency of the PSI for bone tumor~     resections within the pelvis with respect to the reference method.~   "
78104|NCT02544698|"~     This study evaluates the safety of Pneumococcal 13-valent Conjugate Vaccine in Healthy People~     Aged 2 Months and Older.120 Subjects will be equally divided into 4 groups,including 18 years~     and older,2-5 years old, 2 months old and 3 months old. Subjects aged 18 years and 2-5 years~     old will receive one dose of PCV13 vaccine,while subjects aged 2 and 3 months will receive 3~     doses of PCV13 vaccine,injected at 2, 4, 6 months or 3、4、5 months respectively.~   "
78105|NCT02544685|"~     Febrile neutropenia (FN) is a major life-threatening treatment complication in cancer~     patients undergoing intensive chemotherapy. Endogenous flora is considered to be one of the~     main sources of infections during neutropenia. Competitive inhibition of gut mucosal~     colonization by pathogenic microorganisms using synbiotics could represent one of the~     potential options for its prevention. Synbiotics represent combination of two components:~     probiotics and prebiotics. Probiotics are live microorganisms, which in form of drugs or food~     supplements administered at a sufficient dose help to maintain health beneficial microbial~     balance in the digestive tract of a human or other host. Prebiotics are food ingredients~     nondigestible for our digestive enzymes, but can be fermented by bacteria in our bowel and~     this way selectively stimulate growth or activity of specific saccharolytic bacterial~     strains. These changes in composition of our microflora may bring benefits on host well-being~     and health. Based on the results of human and animal studies, probiotics probably can not~     only decrease the level of gut colonisation with pathogenic bacteria, but may also lead to~     reduction in the duration of neutropenia, accelerate the restitution of the intestinal mucosa~     and boost immunity. Despite a significant number of studies on probiotics still only little~     evidence of their safety especially in immunocompromised patients is available.~      To help find new options for increasing quality of healthcare for children cancer patients~     and also to evaluate safety of this new approach investigators designed double-blinded~     placebo controled multicenter study aimed to decrease the number of febrile episodes using~     prevention with synbiotic.~   "
78106|NCT02544672|"~     The objective of this study is to evaluate the functional benefits of a myoelectric~     Elbow-Wrist-Hand orthosis for persons with upper limb paralysis caused by a cerebrovascular~     accident (CVA).~   "
78107|NCT02544659|"~     This study is designed to evaluate long term efficacy of intravenous bisphosphonates for bone~     marrow edema in patients with SAPHO syndrome.~   "
78108|NCT02544646|"~     It has been hypothesized that the biomechanical properties of the optic nerve head and/or~     sclera play a role in the development of glaucoma. One approach of gaining insight into the~     biomechanical properties of the eye by the means of clinical studies is based on the~     Friedenwald equation, representing a pressure-volume relationship. This equation represents~     the so called ocular rigidity, which expresses the elasticity of the globe.~      In order to be able to solve the equation, measurements of fundus pulsation amplitude (FPA)~     with laser interferometry and dynamic contour tonometric assessment of the pulse amplitude~     (PA) have to be performed.~      In addition choroidal thickness will be assessed with OCT before and after trabeculectomy,~     since results in choroidal thickness measurements in patients with glaucoma are~     controversial.~      The focus of this study lies on the changes of ocular rigidity and choroidal thickness after~     surgical trabeculectomy in patients with primary open angle glaucoma (POAG) or~     pseudoexfoliation glaucoma (PEX).~   "
78109|NCT02544633|"~     MGCD265 is an orally administered receptor tyrosine kinase inhibitor that targets MET and~     other receptors. This study is a Phase 2 trial of MGCD265 in patients with locally advanced,~     unresectable or metastatic non-small cell lung cancer (NSCLC) that has activating genetic~     changes of the MET gene (mutation or amplification [increase number of gene copies]). Testing~     for tumor gene changes can be performed in tumor tissue or blood samples. Patients must have~     previously received treatment with chemotherapy. The number of patients to be enrolled will~     depend on how many enrolled patients experience tumor size reduction. MGCD265 will be~     administered orally, twice daily. The study is designed to evaluate whether the number of~     patients experiencing tumor size reduction is substantially higher than would be expected~     with other available treatments.~   "
78110|NCT02544620|"~     The purpose of this study is to evaluate feasibly of outpatient Total Knee Replacement, Total~     Hip Replacement and Unicompartmental Knee Replacement in a modern fast-track setup. The~     design is as an observational prospective study, evaluating patients that fulfil discharge~     criteria on the day of the surgery. The investigators will further evaluate safety aspects,~     such a early morbidity and mortality, as well as patient satisfaction.~   "
78111|NCT02544607|"~     Ketamine has been shown to decrease symptoms of anxious depression quickly. This decrease has~     been shown to last for up to one month. MRI technology will be used before and after ketamine~     for patients with depression to examine the extent to which certain brain areas predict~     ketamine's antidepressant effects.~   "
78112|NCT02544594|"~     This study compares standard treatment plus Extra-Corporal Life Support (ECLS) versus~     standard treatment alone in patients with cardiogenic shock due to myocardial infarction.~   "
78113|NCT02544581|"~     This is an exempt, retrospective study of a limited set of information obtained from~     patients' medical records at 10 to 12 substance abuse treatment programs combined with~     alcohol breath analyzer results during up to 3 years of aftercare monitoring. The study~     objectives are 1) to compare the compliance rates and likelihood of achieving sustained~     sobriety for aftercare patients in mandated (eg, impaired professionals) versus non-mandated~     monitoring programs and 2) identify components within patients' monitoring agreements that~     are significantly correlated with positive outcomes.~   "
78114|NCT02544568|"~     Meal composition is important for blood sugar levels in patients with diabetes. The aim of~     this study is to investigate if a meal composition of fat, protein and carbohydrate is~     important for the hormonal and inflammatory responses Patients with type 1 and type 2~     diabetes and healthy controls will be included in the study. At four different occasions the~     participants will receive lunch with the same amount of calories but different composition of~     fat, protein, carbohydrate and fiber. Blood samples will be taken before and after the meals.~     The participants will estimate their satiety. In addition participant will fill in~     questionnaires about their food habits and wellbeing.~      This study is the first study to compare both hormonal and inflammatory responses, as well as~     psychological aspect of the meals, after meals with different composition. Results from this~     study will help to make recommendation about meal composition which is beneficial for~     patients with diabetes type 1 and type 2.~   "
78115|NCT02544555|"~     There are two ways of approaching atherosclerotic chronic occlusive femoro-popliteal arterial~     lesion with guide wire. One is the intraluminal approach of passing guide wire through the~     atheroma, the other is the subintimal approach of passing wire through the subintima of the~     vessel.~      Either of these two interventional technique can be chosen depending on the character of the~     lesions they have their own pros and cons which affects the success of the intervention. The~     study is limited to retrospective studies to which interventional technique is better for~     post-procedural recurrence rate, however there is no prospective randomized controlled study.~   "
78116|NCT02544542|"~     This study will try to evaluate the effectiveness and safety of a new method for achieving~     mild hypothermia, i.e.,mild hypothermia therapy through rectum. Half of participants will be~     treated by the widely-used hyper-hypothermia blanket method, while the other half will be~     treated by the investigators' new method.~   "
78117|NCT02544529|"~     The purpose of this study is to test the hypothesis that myopia progression can be slowed or~     prevented by low dose Echothiophate Iodide.~   "
78118|NCT02544516|"~     In schizophrenia, dislocation of psychic functions involving a loss of contact with reality~     is frequently found. A fragmentation of motor and sensory perceptions could be held~     responsible (Fuchs, 2005). However, automatic integration between perception and action is~     the necessary condition to be in relationship with the world. Affordance is the~     experimental link between object perception and actions potentially associated (Gibson (1977,~     1979) explored by Stimulus Response Compatibility (SRC) paradigm. The existence of visual~     motor neurons leads us to postulate that the affordance effect can be assisted by a~     visuomotor priming of a hand in a position to grasp. With Tucker & Ellis sensory motor~     compatibility task, we study the capacity of affordance in schizophrenia, as well as the~     impact of perceptual motor priming on these affordance effects.~   "
78119|NCT02544503|"~     The purpose of this study is to identify and establish how the area of the brain that~     controls motor function (motor cortex) might serve as a new focus for treatment for stroke.~     The therapeutic intervention aims to identify protocols that improve motor performance after~     stroke.~   "
78120|NCT02544490|"~     The objectives are to:~        1. derive and validate a panel of miRNAs that are consistently differentially expressed in~          the plasma of patients with and without sepsis~        2. investigate the prognostic and predictive values of the panel of miRNAs to guide~          treatment~        3. investigate the roles of these differentially-expressed circulating miRNAs in immune~          modulation during sepsis~      The methodology involves sampling of blood from controls and subjects in the sepsis continuum~     at their earliest presentation in the emergency department longitudinally to hospitalization.~     The investigators will develop panels of miRNAs that are specific to early and late stages of~     sepsis, and correlate clinical, biochemical and microbiological outcomes with these miRNAs.~   "
78121|NCT02544477|"~     The primary objective of this study is to evaluate the effect of early application of nasal~     high flow oxygen therapy after pulmonary lobectomy on the incidence of postoperative~     hypoxemia~   "
78122|NCT02544464|"~     The objective of the present study is to determine the impact of intraoperative IV-iron~     supplementation on postoperative oxygenation profile by comparing the postoperative PaO2/FiO2~     ratio with or without IV-iron supplementation in old patients undergoing elective uni-limb~     total knee arthroplasty surgery.~   "
78123|NCT02544451|"~     Study 110 is a Phase 3, multicenter study in subjects aged 6 years and older with cystic~     fibrosis (CF) who are homozygous for the F508del-CF transmembrane conductance regulator~     (CFTR) mutation and who participated in Study 109 (NCT02514473) or Study 011B (NCT01897233).~     Study 110 is designed to evaluate the safety and efficacy of long term treatment of~     lumacaftor in combination with ivacaftor.~   "
78124|NCT02544438|"~     A Phase I/IIa, open-label, uncontrolled study to evaluate the safety and efficacy of~     Astarabine (BST-236) as single agent in patients with refractory or relapsed Acute Myeloid~     Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL) disease~   "
78127|NCT02544399|"~     After the age of 50, one in three women and one in eight men will experience at least one~     fragility fracture during the rest of their lives. It is currently recognized that physical~     activity has an osteogenic actions, especially when it includes the impact transmitted to the~     skeleton. In this context, the investigators propose a study to determine whether the regular~     practice of golf could be particularly beneficial for the skeleton, not only in the lower~     limbs, due to repeated impacts to the ground when it requires sustained walking, but also the~     upper limbs due to the impacts transmitted by the club at the time of striking the ball, as~     has been amply demonstrated with racquet sports.~   "
78128|NCT02544386|"~     In hemiplegic, there is very little data on the impact of neurological deficit on the~     microarchitecture independent of bone mineral density and composition of the bone marrow.~     Rare studies have shown the relationship between some micro-architectural parameters and~     severity of neurological deficit. There is no study in humans on the evolution of the~     parameters of the microarchitecture assessed by 3D micro-tomography in the early phase of the~     installation of neurological deficits after stroke, in terms of a bearing bone, tibia, that a~     non-load bearing bones, radius.~   "
78129|NCT02544373|"~     The objectives of this study are to determine the effects of obstructive sleep apnea (OSA) on~     cognitive function in patients with multiple sclerosis (MS); and to evaluate whether OSA~     treatment with positive airway pressure therapy could improve cognitive dysfunction in MS~     patients who have OSA.~   "
78130|NCT02544360|"~     The purpose of this study is to determine whether photoaging mobile app promoting poster~     campaigns are effective to reduce smoking prevalence among adolescents in Germany. This is~     measured via questionnaire.~   "
78131|NCT02544347|"~     The aim of the present study were 1) to determine the role of these adipokines in the~     pathogenesis of periodontal disease, inflammation and tissue destruction comparing with~     gingival crevicular fluid (GCF) levels of TNF-α, which has a known pro-inflammatory effect in~     periodontal disease, 2) to investigate the effect of non-surgical periodontal treatment on~     GCF vaspin and omentin levels in type 2 diabetic (T2DM) patients with Chronic Periodontitis~     (CP).~   "
78132|NCT02544334|"~     Rheumatoid Arthritis (RA) is a chronic and potentially severe autoimmune disease affecting 2~     million in the United States. The role of environmental factors in modulating autoimmunity~     pathogenesis has been clearly described and yet the specific mechanisms of action remain~     poorly understood. A growing body of evidence implicates microbiota of mucosal surfaces in~     the development of autoimmune disorders. Various studies have clearly linked RA to~     periodontal disease. The latter is linked to the red-complex that includes the oral bacterium~     Porphyromonas gingivalis. And yet there has not been a systematic analysis of the oral~     microbiota in RA to determine whether there are specific markers for P. gingivalis (and other~     oral bacteria) that are linked to RA.~      In this study, the investigators will characterize oral microbial composition (microbiome)~     and gene content (metagenome) of DNA isolated from oral samples obtained from patients with~     (i) early stage RA prior to biologics treatments and (ii) subsets of RA patients who are~     responsive or unresponsive to anti-TNF-alpha therapy. The innovative aspect of this study is~     going beyond the identification of oral bacterial species, to the level of strains and genes~     that are associated with these groups. The overall hypothesis is that oral microbial~     variation exists between individuals that influences development of autoimmunity and~     autoimmune disease.~   "
78133|NCT02544321|"~     Type 1 diabetes (T1D) continues to be a disease plagued by hyperglycemia, insulin resistance~     (IR), and increased cardiovascular disease (CVD) despite advances in insulin delivery and~     glucose monitoring. Therefore new approaches are needed. Bromocriptine (BC), a dopamine (DA)~     agonist, has long been widely used for treating Parkinson's disease and prolactinoma. Its~     recent approval in a quick release formulation, BCQR, for type 2 diabetes (T2D) is an~     exciting development, representing a novel mechanism for improving IR. BCQR has not been~     studied in T1D, but it's mechanism of action, mechanistic studies, and preliminary data~     support the proposed study of possible benefits of BCQR on insulin action, glycemic control,~     and the vasculature in T1D. This study has received an exemption from the FDA to study BCQR~     in adults with T1D and an IND approval (131360) to study BCQR in adolescents with T1D. This~     is a random-order, double-blind, placebo-controlled study of a 4 week intervention. Outcomes~     will include fasting and postprandial glucose, glycemic variability, insulin dosing,~     hypoglycemia frequency and awareness, sleep quality, and metabolic hormone levels.~   "
78134|NCT02544308|"~     The purpose of the trial is to establish whether adjuvant therapy with lenalidomide +~     dexamethasone after radiotherapy can improve progression free survival in patients with high~     risk solitary bone plasmacytoma compared with RT only.~   "
78135|NCT02544295|"~     The objective of this research is to develop original virtual reality scenarios and/or new~     virtual reality equipments to evaluate or diagnose pathologies, such as attention deficit~     disorders or neuropsychiatric pathologies, addiction, anxiety or depression or pathologies~     interfering with sleep/wake disorders.~   "
78136|NCT02544282|"~     In this prospective trial, Stage 1-3 patients having mastectomies or isolated lumpectomy with~     axillary node dissection will be randomly assigned to general anesthesia with opioids~     combined with a Pecs II block or to general anesthesia with opioids combined with a placebo~     Pecs II block. Participants will be followed postoperatively during their entire hospital~     stay to determine the effectiveness of Pecs II block and opioids versus placebo Pecs II block~     and opioids as postoperative pain treatment.~   "
78137|NCT02544269|"~     The study evaluates the hemodynamic effect of lumbosacral plexus blockades versus spinal~     anesthesia for hip replacement. Half of participants will receive lumbosacral plexus blockade~     and the other half will receive continuous spinal anesthesia.~   "
78138|NCT02544256|"~     The purpose of this study is to determine whether mild hypothermia causes reduction of~     vasoconstriction in microcirculation after clipping of aneurysms, and affects the blood flow~     in small diameter arteries at operating site (ischemia-hyperemia) and occurrence of~     vasospasms during the period of 14 postoperative days measured by transcranial Doppler.~   "
78199|NCT02543450|"~     In hemiplegic stroke patients, gait performance is affected by impaired walking endurance.~     Evidence has shown that higher exercise intensity improves cardiovascular fitness, while~     greater dose in task repetition benefits locomotor function. Therefore, the goal of this~     study is to examine the effect of a combined cardiovascular/task-oriented interval training~     programme on the walking capacity of chronic stroke individuals and the improvement in their~     participation.~   "
78139|NCT02544243|"~     Development of an active second-line treatment option for metastatic breast cancer patients~     previously pre-treated with anthracyclines and taxanes in neoadjuvant, adjuvant or palliative~     settings.For each randomisation arm, 100 patients will be included. The trial was performed~     as a 2-stage phase II study according to the optimal design by Simon with overall response~     rate as the primary objective.~      Study Design:~      Arm A Vinorelbine 25 mg/m2 d1, 8;Gemcitabine 1000 mg/m2 d1, 8 q 3 weeks Arm B Vinorelbine 25~     mg/m2 d1, 8;Cisplatin 25 mg/m2 d1, 2,3 q 3 weeks~   "
78140|NCT02544230|"~     The investigators retrospectively evaluated the efficacy of granulocyte transfusions as~     adjunctive treatment for severe infections in neutropenic fever unresponsive to antimicrobial~     therapy in hematological patients.~   "
78141|NCT02544217|"~     Mitochondrial Diseases are rare progressive, multi-system, often early fatal disorders~     affecting both children and adults. KH176 is a novel chemical entity currently under~     development for the treatment of inherited mitochondrial diseases, including MELAS~     (Mitochondrial Encephalomyopathy, Lactic acidosis, and Stroke-like episodes), Leigh's Disease~     and LHON (Leber's Hereditary Optic Neuropathy). KH176 is a potent intracellular redox~     modulating agent targeting the reactive oxygen species which are important in the~     pathogenesis of disorders of mitochondrial oxidative phosphorylation. After demonstrating a~     favourable safety profile in the pre-clinical testing, the safety, tolerability and~     pharmacokinetic and pharmacodynamic characteristics of the compound will now be evaluated in~     healthy male subjects in this trial~   "
78142|NCT02544204|"~     To investigate the efficacy of the administration of JVS-100 delivered via direct~     intramuscular injections on a 3 month and 6 month composite endpoint of wound progression,~     healing and limb loss in patients with severe peripheral arterial disease with non-healing~     chronic wounds who undergo an open bypass grafting or endovascular procedure for treatment of~     infrapopliteal disease and are dosed within 12 days and 3 months following the procedure.~   "
78143|NCT02544191|"~     Preliminary reports showed that hormonal treatment may improve the chance of retrieving~     viable testicular sperm from men with NOA. It was generally believed that gonadotrophin~     treatment would be ineffective in the presence of high plasma levels of endogenous~     gonadotrophin.The purpose of this study is to determine whether GnRHa(gonadotropin-releasing~     hormone agonist) combined with hCG(human chorionic gonadotropin) and hMG(human menopausal~     gonadotropin) are effective in the treatment of non-obstructive azoospermia.~   "
78144|NCT02544178|"~     The survival time and the number of long time survivors after radiotherapy in brain cancer~     patients have increased for the last decades. Therefore the topic of late-delayed neurotoxic~     effects of this therapy gains more and more importance. Among these side effects, the main~     and most frequent one is the leukoencephalopathy, a diffused and progressive damage of the~     white matter characterized by myelin loss, loss of axons and vascular lesions. The incidence~     rate assessment, as well as the occurrence time, is based on retrospective studies with low~     numbers of patients, but seems to reach 30 to 50 % of the patients according to the~     follow-up. The risk seems to be increased during the first two years after the radiotherapy,~     but persists for decades.~      To gain further insight in the radiation-induced leukoencephalopathy, the objective of this~     project is to study the onset and evolution of leukoencephalopathy in a 3-year prospective~     cohort of patients having undergone cerebral radiotherapy for glioma (stage 3-4), using~     specific cognitive tests, Magnetic Resonance Imagery (MRI) scans of the brain and predictive~     bio-markers of cognitive impairments.~   "
78145|NCT02544165|"~     The aim of this study was to investigate the difference in accumulation of AGEs (advanced~     glycation end-products) in the tissues of individuals who smoke in comparison with~     individuals who do not as well as of individuals who consume caffeine versus those who do~     not, and finally to examine the probable differences concerning participants' haemodynamic~     parameters.~   "
78146|NCT02544152|"~     A study of the efficacy and safety of Lubiprostone in subjects diagnosed with IBS-M/IBS-U.~   "
78147|NCT02544139|"~     This study assesses the specificity of Chagas Detect™ Plus (CDP) rapid test versus standard~     reference tests (e.g. RIPA or IFA) for Chagas diagnosis in the US.~      The Chagas Detect™ Plus Rapid Test is a rapid immunochromotagraphic strip assay for the~     qualitative detection of antibodies to Trypanosoma cruzi (T. cruzi) in human serum or whole~     blood samples. Reactive assay results are presumptive evidence of Chagas infection.~      This study will enroll males and females 18-70 years of age from areas non-endemic for Chagas~     infection. A fingerprick blood sample and a venous blood sample (for processing to serum)~     will be collected from each subject. Subject age, gender, and symptoms will be recorded. For~     this study, samples will have no personally identifiable information.~      CDP and reference tests will be performed by different operators who are laboratory staff~     members. These staff members, blinded to each other's results, will evaluate the samples from~     each method independently.~   "
78148|NCT02544126|"~     The purpose of this study is to investigate how working with a computer program may affect~     mood, feelings, overall health, and markers in blood in young adults with HIV.~   "
78149|NCT02544113|"~     This is a 24-month, Phase II, multi-center, two-arm, randomized controlled study of adult~     patients receiving a single organ liver transplant from a deceased donor; the purpose being~     to determine the efficacy of Thymoglobulin® induction and delayed initiation of CNI in the~     long-term preservation of renal function after liver transplantation. This study is based on~     the outcomes of an earlier phase 1 pilot study which was performed at the Cleveland Clinic.~      This study will be conducted at 3 centers, with 110 subjects randomized 1:1 into two groups:~     Group 1 will receive Thymoglobulin® induction, (4.5 mg/Kg, in 3 doses of 1.5 mg/Kg/dose) with~     delayed initiation of CNI to begin on Day 10 post LT. Group 2 will receive early CNI~     initiation (to be started no later than Day 2 post LT), and no Thymoglobulin® induction (or~     any other antibody).~      All subjects will also receive a maintenance immunosuppressive regimen consisting of~     corticosteroids and mycophenolate mofetil (MMF) according to standard of practice in~     orthotopic liver transplantation (OLT).~      Subjects will be consented pre-transplant. Participation may last up to 12 months post OLT.~     There are 15 study-related visits which will be completed during standard of care (SOC)~     visits.~   "
78209|NCT02543320|"~     The goal of this study is to learn how the brain processes pain and if using neurofeedback~     training can help teach patients ways to modify their own brain waves to decrease the~     perception of pain and improve quality of life.~   "
78150|NCT02544100|"~     The purpose of this study is to create a neonatal neurologic biological big data center named~     Neonatal Neurologic Intensive Care Network in China with neonatal systematic information,~     biological samples and genomics & genetic data on neonates born with neonatal severe~     encephalopathy. It also can predict brain injury as cerebral function monitoring through big~     data and recommend appropriate treatment. In addition, the following samples will be~     collected in a bio-bank in for future studies: blood, urine, and cerebrospinal fluid (CSF)~     samples.~   "
78151|NCT02544087|"~     The present study is designed to confirm the therapeutic effects of heat-clearing and~     blood-activating Chinese medicinal components in treatment of Acute Cerebral Infarction (ACI)~     and to investigate the therapeutic mechanisms of multi-target anti-inflammatory action~     involved from the standpoint of pathology, cell and molecular biology, as well as immunology.~   "
78152|NCT02544074|"~     The Self-Administered Gerocognitive Examination (SAGE) is a valid and reliable cognitive~     assessment tool used to identify both Mild Cognitive Impairment (MCI) and early dementia.~     SAGE's self-administered feature, pen and paper format, and four equivalent interchangeable~     forms allows it to be given in almost any setting, does not require any staff time to~     administer and makes it practical to rapidly screen large numbers of individuals in the~     community or in their home.This trial is being conducted to study the validity of SAGE in a~     digital format (eSAGE) for cognitive screening.~      The investigators will analyze the data to learn the correlations between eSAGE and gold~     standard neuropsychological testing designed to differentiate normal cognition from MCI and~     early dementia. The investigators will also find out whether the paper (SAGE) and electronic~     (eSAGE) versions of SAGE could be used interchangeably or not.~   "
78153|NCT02544061|"~     The purpose of this study is to determine the safety and tolerability of NM-IL-12 relative to~     standard of care (SOC; control) in subjects with open surgical wounds.~   "
78154|NCT02544048|"~     Background:~      People with malaria often show altered immune responses to many illnesses and vaccines. This~     means that the malaria might cause immune suppression. It is not clear how or which vaccines~     are impacted by malaria. It is also not clear if the impacts are such that people should be~     preemptively treated before they get vaccinations. Researchers want to see if there is a link~     between taking an antimalaria drug prior to getting vaccines and the immune response to those~     vaccines. To do this, they will study people who are taking part in certain NIAID studies.~      Objectives:~      To compare the proportion of PD1+ CD4 T cells among all T cells in vaccine immune responses~     in adults who have or have not received antimalarials prior to getting a Menactra vaccine.~      Eligibility:~      Healthy Malian adults who:~      Were previously enrolled in NIAID Protocol 13-I-N109 or 15-I-0044~      Reside in Bancoumana and neighboring villages~      Are not pregnant~      Design:~      Participants will be screened with a physical exam.~      Participants will get the vaccines listed below as part of Protocol 13-I-N109 or 15-I-0044.~     This study will follow their schedule.~      At each visit, participants will give a blood sample. They will also have a physical exam.~     Each visit will last 1 to 2 hours.~      At visit 1, participants will get a hepatitis vaccine.~      Two weeks later, participants may get the antimalarial drug Coartem . They will be chosen at~     random.~      Two weeks later, participants will get Menactra .~      Participants will have 5 follow-up visits after they get Menactra .~      The study will last up to 4 months.~   "
78155|NCT02544035|"~     Background:~      Play during childhood is an important part of healthy development, and children can learn~     many things when they play. Much of the time that children spend playing is with toys.~     However, children at different ages need different types of toys to engage in healthy play.~      Understanding children s play with toys is important to the National Institute of Child~     Health and Human Development (NICHD), and to the U.S. Consumer Product Safety Commission~     (CPSC). The CPSC rates toys that are currently available in the United States for children~     for age appropriateness. NICHD will share the findings of this study with CPSC to aid in~     their toy rating process.~      Objective:~      To categorize traditional and contemporary children s products and toys into age appropriate~     groups.~      Eligibility:~      Healthy children 6 months to 12 years old.~      Their parents.~      Design:~      Participants will be screened with a phone call with the parents.~      Participants will complete surveys online or on paper, and by phone. These will ask about~     demographic facts, behavior, thoughts on parenting and toys, and child development.~      Participants will have 1 study visit. The child will play with toys by himself or herself.~     Then they will play with their parent. A researcher will observe. The sessions will be~     videotaped.~      Children will share their thoughts about the toys by pointing at a smiley face scale.~      Parents will fill out a short survey. Then can choose to participate in a 1-hour focus group.~   "
78156|NCT02544022|"~     Background:~      People with neurofibromatosis 1 (NF1) who have plexiform neurofibromas (PNs) can have pain~     that affects their daily lives. This study aims to improve questionnaires that measure their~     pain, daily living, and physical functioning.~      Objectives:~      To examine and improve questionnaires about daily living for people with NF1 and PNs.~      Eligibility:~      People ages 5 and older with NF1 and a PN~      Design:~      Participants will be screened with medical history.~      This study will have 2 phases.~      Phase 1 participants will talk about existing pain assessment questionnaires and how PNs~     affect their life. They will have group discussions of up to 8 people of a similar age with~     NF1 and PNs, or the parents of children with it. These will last about 90 minutes. Children~     ages 5 to 7 and their parents will have one-on-one meetings instead. These will last about 45~     minutes. Discussions will be audiotaped. After the questionnaires have been changed,~     individual interviews will discuss the new wording, instructions, questions, and electronic~     format of the new forms.~      Phase 1 participants may be invited to Phase 2.~      Phase 2 participants will complete the new questionnaires. These may be pen-and-paper or~     electronic. The questionnaires will take about 30 minutes for adults and teens. Children will~     work one-on-one with a staff member and may need up to 45 minutes. A small group of~     participants will be complete the forms twice in clinic and 1 month later at home. Also, a~     small group who start a new pain treatment or have a dose increase in their treatment will~     complete the forms twice before the treatment change and 1 month later.~   "
78256|NCT02542696|"~     A 24-week, prospective, multi-center, open-label, Phase 3 study in L-Dopa responsive PD~     patients with motor fluctuations (OFF episodes), designed to evaluate the long-term safety,~     tolerability and efficacy of APL-130277.~   "
78157|NCT02544009|"~     Background:~      Many people regain the weight they lose through diet and exercise. This might happen because~     the weight loss slows their metabolism. This slowing is called metabolic adaptation. It may~     cause people to regain weight if they do not keep up high levels of exercise or major caloric~     restrictions. Researchers want to find the long-term effects of metabolic adaptation in the~     previous Biggest Loser study participants. They hope to learn the body s response to~     lifestyle changes that result in weight loss. They also want to see if certain changes can~     lead to longer-term success in maintaining weight loss.~      Objectives:~      To better understand the long-term metabolic changes caused by rapid weight loss achieved~     through diet restriction and vigorous physical activity.~      Eligibility:~      Former Biggest Loser research study participants (Protocol No. PBRC29008).~      Design:~      Participants will be screened with a phone interview.~      This study has 3 phases.~      Phase 1 will last at least 3 weeks. Participants will receive a physical activity monitor and~     wireless scale. These will send their daily weight and activity back to NIH.~      In Phase 2, participants will stay at NIH for 3 days. Their metabolism will be measured~     through:~      Their activity monitor~      Urine samples and daily body weight~      Medical review and physical exam~      Fasting for 12 hours each night for a blood draw the following morning~      DEXA: a low-dose x-ray of the body~      BIS: Electrodes on the hand/wrist and foot/ankle measure body water content.~      Phase 3 will last at least 3 weeks. Participants will:~      Continue to monitor their daily weight and activity~      Collect urine samples and send them back to NIH~   "
78158|NCT02543996|"~     Background:~      Studies show that rare genetic variants might lead to diseases. Researchers want to collect~     blood and tissue samples so they can study them and better understand diseases.~      Objective:~      To collect blood and tissue samples for studies to identify underlying causes of disease.~      Eligibility:~      People of all ages~      Design:~      Participants will have blood and/or tissue samples collected.~      Samples can be collected at the NIH Clinical Center. Participants doctors can collect the~     samples and send them to NIH. NIH staff can collect samples off site.~      For blood samples, blood is taken from an arm vein using a needle.~      Tissue collection may involve:~      Buccal smear: Cells are collected by scraping the inside of the cheek with a cotton swab.~      Saliva collection: Participants spit into a cup.~      Skin biopsy: A special needle takes a very small skin sample.~      Surgical waste tissue: If participants have surgery, NIH may receive samples of tissue that~      would routinely be removed.~      Umbilical cord or cord blood collection: If a participant has a baby, NIH may receive a~      small piece of the umbilical cord or blood from the cord once the baby is delivered.~   "
78159|NCT02543983|"~     Background:~      There are no good treatments for people considering suicide. Researchers want to study~     suicide with questions, blood tests, brain imaging, and sleep studies. They hope to better~     understand suicide, so they can help suicidal people.~      Objective:~      To understand what happens in the brain when someone has thought about or attempted suicide.~      Eligibility:~      Group 1: Adults ages 18 70 who have thought about or attempted suicide recently~      Group 2: Adults ages 18 70 who have thought about or attempted suicide in the past~      Group 3: Adults ages 18 70 who have depression or anxiety, but have never thought about~     suicide~      Group 4: Healthy volunteers the same ages.~      Design:~      Participants will be screened in another protocol. Adults who have recently thought about or~     attempted suicide must be referred by a doctor. They may do up to 3 phases of this study.~     Groups 2, 3 and 4 will do only Phase 1 and will not get ketamine.~      Phase 1: 1 week in hospital. Participants will have:~      Physical exam.~      Questions about thoughts and feelings.~      Thinking and memory tests and simple tasks.~      Blood and urine tests.~      Two MRI scans. Participants will lie on a table that slides into a metal cylinder that takes~     pictures. They will have a coil over their head and earplugs and do a computer task.~      Sleep test. Disks and bands will be placed on the body to monitor it during sleep.~      Magnetic detectors on their head while they perform tasks.~      A wrist monitor for activity and sleep.~      Lumbar puncture (optional). A needle will collect fluid from the back.~      Shock experiments (optional). Participants will observe pictures and sounds and feel a small~     shock on the hand.~      Phase 2: 4 days in hospital. A thin plastic tube will be placed in each arm, one for blood~     draws, the other to get the drug ketamine once. Participants will repeat most of the Phase 1~     tests.~      Phase 3: up to 4 more ketamine doses over 2 weeks.~      Participants will have follow-up calls or visits at 6 months and then maybe yearly for 5~     years.~   "
78160|NCT02543970|"~     The primary objective of this study is to confirm the safe and effective use of the Celluma3~     for the reduction in the appearance of periorbital wrinkles.~   "
78161|NCT02543957|"~     An Endoscopic retrograde cholangio pancreatography (ERCP) with cholangioscopy (endoscope to~     directly visualize the bile duct ) is a procedure (a small flexible tube that is inserted~     into the participants mouth to the participants stomach and into the participants liver to~     visualize the bile duct) that is usually performed in patients for the following purposes :~        1. The removal of all stones from the participants bile duct (if present).~        2. Acquiring a tissue sample biopsy from any common bile mass to examine (if present).~        3. Acquiring tissue sample biopsy from common bile duct narrowing (if present). However~          this procedure is associated with an increase risk of infection compared with the~          standard ERCP (ERCP without cholangioscopy). Previous studies have shown that despite~          the administration of antibiotics prior to these procedures, infection still occurs.~          This leads to a suspicion that other factors may be the cause in these infections.~          Factors such as age, race, gender and ethnicity have not been fully explored yet. This~          study aims to examine these factors in addition to others in patients who are undergoing~          ERCP with cholangioscopy as part of their routine medical care. This examination will~          allow us to bring out if any of the above mentioned factors may be involved in the~          development of an infection after ERCP with cholangioscopy.~   "
78162|NCT02543944|"~     Overall, this proposal seeks to improve treatment strategies for the significant public~     health problem of prescription opioid dependence by determining whether gabapentin, a~     non-narcotic pharmaceutical agent with minimal abuse potential and preliminary efficacy, will~     be effective in ameliorating withdrawal symptoms, craving and illicit drug use in~     prescription opioid dependent participants undergoing a 10-day detoxification from~     buprenorphine. In addition, the acceptability and feasibility of transitioning to depot~     naltrexone therapy will also be determined. If successful, this study would provide data to~     support further development of gabapentin as a pharmacological tool for improved outcomes~     during opioid detoxification as well as an integrated outpatient approach for treating~     prescription opioid dependence.~   "
78163|NCT02543931|"~     The purpose of this study is to find out whether turmeric dietary supplements that are~     available over the counter for general use in the United States are safe and useful when~     taken specifically for the treatment of rheumatoid arthritis (RA) and how the active~     principles in turmeric are broken down and metabolized by the body in individuals with RA.~   "
79753|NCT02523040|"~     This research study is studying a chemotherapy drug Lenalidomide as a possible treatment for~     one of three histiocyte disorders: Langerhans cell histiocytosis (LCH), Erdheim-Chester~     disease (ECD), or histiocytic sarcoma (HS).~   "
78165|NCT02543905|"~     Prostate cancer is the most common cancer in men in the United Kingdom (UK) with over 40,000~     men diagnosed each year. Prostate cancer (PrCa) can run in some families and research studies~     have identified several genetic changes that are thought to increase the risk of developing~     prostate cancer. This study aims to look at the potential risk of these changes in targeted~     screening. Some of these changes may cause a very slight increase in prostate cancer risk~     while others may cause a much larger increase in risk of developing prostate cancer. The~     investigators will invite men with a family history of prostate cancer for targeted prostate~     screening (Prostate Specific Antigen (PSA) testing and a biopsy of the prostate gland) and~     genetic profiling. This research will help us to determine what the risk of cancer is for men~     who have inherited these genetic changes and also increase our knowledge about the role of~     genetics in developing prostate cancer targeted screening. Some of these changes may cause a~     very slight increase in prostate cancer risk while others may cause a much larger increase in~     risk of developing prostate cancer.~      The investigators will invite men with a family history of prostate cancer for targeted~     prostate screening (PSA testing and a biopsy of the prostate gland) and genetic profiling.~     This research will help us to determine what the risk of cancer is for men who have inherited~     these genetic changes and also increase our knowledge about the role of genetics in~     developing prostate cancer.~   "
78166|NCT02543892|"~     This study will determine if PATH-wSP, a vaccine against a germ that causes pneumonia, is~     safe and induces immune responses in adults and toddlers. The study vaccine will be compared~     to placebo. First adults will receive a 2 injections of a lower dose of the vaccine or~     placebo, 28 days apart. If the lower dose is safe, then a higher dose will be tested. Once~     the safety is established in adults the lower and higher dose will be tested in toddlers,~     starting with the lower dose.~   "
78167|NCT02543879|"~     This is an open-label, multicenter, dose-escalation Phase 1/1b study in patients with acute~     myelogenous leukemia (AML)/MDS or non-Hodgkin Lymphoma (NHL), intended to investigate safety,~     pharmacokinetics, and the pharmacodynamic effects of FT-1101 administered via one or more~     intermittent dosing schedules alone and in combination with azacitidine. Once the MTD has~     been established for a treatment cohort, up to 20 additional patients may be enrolled in up~     to 4 expansion cohorts each of select populations of patients with either AML/MDS or NHL at~     the recommended dose for future studies to confirm safety.~   "
78168|NCT02543866|"~     This protocol will evaluate fecal microbiota transplantation (FMT) as a strategy to eradicate~     intestinal colonization of extended-spectrum resistant (ESC-R) Enterobacteriaceae in~     pediatric patients.~      FMT will be performed on subjects with a history of at least one infection due to ESC-R~     Enterobacteriaceae.~      This protocol aims to determine the feasibility, safety, tolerability, and potential efficacy~     of FMT in pediatric patients with a history of ESC-R Enterobacteriaceae.~   "
78169|NCT02543853|"~     The purpose of this study is to determine effect of veres needle entry and direct trocar~     entry on postoperative gastrointestinal functions.~   "
78170|NCT02543840|"~     This randomized program evaluation is undertaken in conjunction with the Department of~     Veterans Affairs Office of Mental Health Operations and the Quality Enhancement Research~     Initiative. It is designed to answer two related questions: (1) Can an evidence-based~     implementation strategy using the CDC's Replicating Effective Programs plus External~     Facilitation (REP-F)enhance the adoption of team-based care in VA General Mental Health~     Clinics, and (2) Does the establishment of such teams via implementation enhance Veterans'~     health status, satisfaction, and perceptions of care? The model for team-based care is the~     evidence-based Collaborative Chronic Care Model (CCM).~      In conjunction with a nation-wide roll-out of the VA's Behavioral Health Interdisciplinary~     Program team (BHIP) initiative, the investigators have structured a randomized, controlled~     program evaluation to answer these questions. Specifically, using a stepped wedge design the~     investigators will randomize 9 VAMCs that have requested support in establishing a BHIP to 1~     of 3 waves of REP-F support: immediate implementation support vs. 4-month vs. 8-month wait~     with dissemination of CCM materials (3 sites per wave). Fidelity and health outcome measures~     will be collected in a repeated measures design at 6-month intervals, and analyzed with~     general linear modeling.~   "
78171|NCT02543827|"~     The purpose of the study is to evaluate the efficacy and safety of a biological vaccine~     (MV140) in women with Recurrent Urinary Tract Infections (RUTI) compared with a placebo~     group.~   "
78172|NCT02543801|"~     This study evaluates two routinely used drug combinations for periarticular injection~     following total hip arthroplasty for pain control. One group will receive liposomal~     bupivacaine, bupivacaine, clonidine, epinephrine and ketorolac. The other group will receive~     ropivacaine, clonidine, epinephrine and ketorolac.~   "
78173|NCT02543788|"~     Patients with multiple sclerosis (MS) may show chronic signs of optic neuropathy (CON) that~     may follow acute optic neuritis (secondary form of CON, S-CON) or occur independently of any~     acute demyelinating lesion of the optic nerve (primary form of CON, P-CON). In both S-CON and~     P-CON, a long term progressive ganglion cell axonal loss occurs. This axonal damage could be~     secondary to retrograde atrophy of axons within plaques of demyelination or a primary~     progressive degeneration of ganglion cells, but the underlying physiopathology has not been~     fully questioned in the different profile types of CON.~      In this project, investigators aim at understanding the pathophysiology of S-CON and P-CON,~     i.e. secondary to demyelination or primary degeneration, in patients complaining of~     persistent visual complaints. In a first cross sectional study, 30 MS patients with mild to~     moderate P-CPON or S-CON and 30 age-matched control subjects will perform an extensive~     neuro-ophthalmological assessment including clinical examination, visual evoked potentials~     (pattern and low contrast), electroretinogram (pattern and multifocal ERG), OCT~     (peripapillary and macular volume scan segmentation protocols) and MRI of the optic nerve. In~     these patients with mild to moderate CON, investigators aim at differentiating patients~     showing predominant demyelination from those showing pure or predominant axonal degeneration.~     Visual function assessment and degree of axonal degeneration will be compared and correlated~     in the two types of underlying pathophysiology and in the group of control subject. In a~     following longitudinal study, the patients will be re-assessed a year later in order to~     evaluate the progression of CON in both profile types. Our hypothesis would be that visual~     function and progression is worse in the degeneration group as compared to the demyelination~     group. This study should help to find reliable measures of the pathophysiology of CON and~     correlate it with the long-term visual prognostic of the disease.~   "
78174|NCT02543775|"~     The primary objective of this study is to determine the feasibility of detecting the sentinel~     lymph node (SLN) in patients with early invasive cervical cancer using a combined~     radioisotope and blue dye technique.~      The investigators hypothesize that the sentinel lymph node (first node draining the~     tumour/cervix) for early stage cervical cancer represents the status of the regional lymph~     node basin (pelvic lymph nodes) and identification of a negative SLN would negate the need~     for complete pelvic lymphadenectomy.~   "
78175|NCT02543762|"~     To assess the feasibility and effectiveness of a program in L-IBD patients using CE targeted~     biopsies~   "
78176|NCT02543749|"~     The aim of this phase I/II trial is induction of anti leukemic T cell immunity in a clinical~     situation of minimal residual disease. This might be a strategy to immunologically~     eradicate the residual leukemia cells. Patients to be included are chronic phase bcr/abl+ CML~     (chronic myeloid leukemia) patients in stable cytogenetic and/or molecular remission.~      These patients can be included if they have:~        1. not achieved a CMR (complete molecular response) or~        2. achieved bcr/abl < 10% on qPCR (quantitative polymerase chain reaction) (=MCyR) (Major~          cytogenic Response), but less than a CCyR (complete cytogenic Response).~      Autologous DC (Dendritic cells), generated under GMP (Good manufacturing conditions)~     conditions, are used as a vaccine. These DC constitutively express all putative tumor~     antigens. In order to ensure sufficient presentation of distinct CML-related antigens,~     particularly in good responders to TKIs, DC are additionally pulsed with peptides from~     bcr/abl, WT-1 (Wilms Tumor Protein) and proteinase-3. Monitoring of T cell reactivity against~     these peptides can then serve as surrogate marker for anti leukemic immunity induced by the~     vaccine. Vaccination is performed with 10^7 DC i.d. (intra dermal) in weeks 1, 3, 5, 8, 11,~     14, 17, 20, 23 and 26. KLH (keyhole limpet hemocyanin) is used as an adjuvant for vaccine~     preparations in weeks 3, 5 and 8 (and 11).~   "
78177|NCT02543736|"~     Knee osteoarthritis (KOA) patients, have impairments in gait and balance. Accurate gait and~     postural balance analysis is needed to detect this impairments. Nevertheless methodological~     quality about the recording of gait and balance analysis in KOA patients is lacking in~     literature.~   "
78178|NCT02543723|"~     Oral chemotherapeutic agents (OCAs) are increasingly being used as an alternative to~     traditional intravenous chemotherapy, and factors promoting this trend include increased~     survival times requiring long-term therapy, acceptability among patients, convenience, and~     cost savings due to reduced hospital time. Although OCAs are commonly preferred by patients,~     adherence to these medications vary. Suboptimal medication adherence leads to loss of~     treatment efficacy, increased toxicity, and increased health care costs. Thus, it is critical~     to develop and test interventions that effectively improve adherence to OCAs. Although the~     medication adherence literature has been criticized for methodological issues, some~     components of interventions have had promising results on adherence such as electronic~     monitored adherence feedback, cognitive-education, nurse-based interventions, and~     technology-based or telehealth strategies. The investigators propose to unify components of~     these effective approaches in a novel way to assess the efficacy and feasibility of two~     telehealth-based strategies (electronic medication-event monitoring with feedback and~     tailored nurse coaching which includes cognitive-education) in an effort increase OCA~     adherence among cancer patients who are at high-risk for non-adherence in rural eastern North~     Carolina.~   "
78179|NCT02543710|"~     MoMaTEC2 aims to test, in clinically oriented studies, the applicability of already~     identified and promising molecular biomarkers, to promote individualisation of treatment for~     patients with endometrial cancer. Predominantly, but not exclusively, such biomarkers have~     shown to be interesting in retrospective analysis of our large prospectively collected~     MoMaTEC1 series.~      Part 1: Performance of a phase 4 implementation trial for optimised stratification of~     surgical treatment, specifically the performance of (para-aortic and pelvic) lymphadenectomy~     guided by validated biomarkers.~      Part 2: Performance of a phase 2b clinical biomarker study to evaluate the predictive~     potential of the biomarker stathmin for taxane treatment response in endometrial and ovarian~     cancer. In this study stathmin will be used as integrated biomarker.~   "
78180|NCT02543697|"~     Patients with tumors in both adrenal glands and slightly elevated cortisol (subclinical~     Cushings syndrome) are offered to go through an adrenal venous sampling to try to quantify if~     the overproduction of cortisol is from one adrenal, or from both sides. If it is one-sided,~     the investigators offer the patient operation.~   "
78181|NCT02543684|"~     The aim of the current study was to compare the effects of three ready-to-eat mixed meals,~     with a high fiber content and low glycemic index, on postprandial glycemic and insulinemic~     response in patients with Type 2 diabetes mellitus (T2DM).~   "
78182|NCT02543671|"~     The primary aim of the current study was to investigate whether the consumption of vitamin D3~     enriched, reduced-fat yellow cheese can counterbalance the expected decrease in serum~     25-hydroxyvitamin D concentration during winter in postmenopausal women in Greece, and in~     what degree it can contribute as a potential food-based strategy for the prevention of~     vitamin D deficiency. A secondary aim was also to investigate any potential effect of the~     intervention in several quality of life (QoL) indices in the population of postmenopausal~     women under study.~   "
78183|NCT02543658|"~     Acute pancreatitis with Intra-abdominal Hypertension have high mortality rate,~     intra-abdominal pressure mainly because of intestinal paralysis which due to edema,~     intestinal gas, fluid and other intestinal dysfunction.Neostigmine is an anti-cholinesterase~     drugs, can enhance intestinal peristalsis, promote flatus, defecation. This study will~     determine the efficacy of neostigmine in the treatment of acute pancreatitis with~     Intra-abdominal Hypertension.~   "
78184|NCT02543645|"~     This is a study to determine the clinical benefit (how well the drug works), safety and~     tolerability of combining varlilumab and atezolizumab. Phase l of the study will enroll~     patients with a number of tumor types; Phase ll will enroll only patients with renal cell~     carcinoma (RCC).*~      *Note: This Study was terminated prior to initiation of Phase II~   "
78185|NCT02543632|"~     Prospective, multi-center, post-market, non-randomized, nested-control, observational study~     of the CE marked CardioKinetix Parachute Implant System.~   "
78186|NCT02543619|"~     Forty healthy patients with including criteria who failed to infra alveolar nerve block~     injection (without lip numbness) have been randomly divided into two groups on a random basis~     and have received Gow-Gates or another inferior alveolar nerve block injection. Endodontic~     access cavity preparation has been initiated after complete anesthesia. If patients felt any~     pain during the steps of caries or dentin removal, Endodontic access cavity preparation or~     canal working length determination, treatment has been stopped and their pain has been~     measured by Heft Parker 170 mm Visual Analog Scale (Zero as no pain and 170 as maximum pain~     ).The data has been analyzed by Mann-U-Whitney and CHI- SQUARE tests.~   "
78187|NCT02543606|"~     Bioequivalence of Two Formulations of Esomeprazole 40mg~   "
90969|NCT02376452|"~     This study is designed to compare the efficacy and safety of two-weekly RAILIRI regimen with~     FOLFIRI regimen in the treatment of advanced colorectal cancer patients in the second-line~     setting.~   "
78188|NCT02543593|"~     Provoked vestibulodynia (PVD) is the most common form of vulvodynia and despite its high~     prevalence and important sexual, conjugal and psychological deleterious repercussions,~     effective evidence-based interventions remain limited. For a high proportion of women,~     significant pain persists despite the currently available treatments. Transcranial~     direct-current stimulation (tDCS) was shown to be effective in various chronic pain~     conditions. So far, only one case report study has shown significant pain reduction in women~     with vulvodynia. The main goal of this randomized controlled trial is to evaluate the~     efficacy of tDCS in women with PVD compared to sham tDCS. Forty women diagnosed with PVD, by~     a gynecologist following a standardized protocol will be randomized to either active or sham~     tDCS for ten 20 minute sessions of 2 mA stimulation over a 2-week period. Outcome measures~     will be collected at baseline, after treatment and at 3-month follow-up. The primary outcome~     is pain during intercourse assessed with a numerical rating scale (NRS). Secondary~     measurements focus on sexual function, vestibular pain sensitivity, psychological distress,~     treatment satisfaction and Patient Global Impression of Change (PGIC). The investigators~     expect that active tDCS treatment will significantly reduce pain during intercourse~     (post-treatment and 3-month follow-up compared to pre-treatment assessment). This trial will~     provide important information for determining the efficacy of a novel and promising~     intervention for women with PVD.~   "
78189|NCT02543580|"~     The purpose of this study is to evaluate the effects of single acupoint or two combination of~     acupoints stimulated with electroacupuncture on patients undergoing radical operation of~     breast cancer~   "
78190|NCT02543567|"~     The purpose of this study is to demonstrate the non‐inferiority of a heterologous prime‐boost~     regimen using Ad26.ZEBOV as prime and MVA‐BN‐Filo as boost administered at different doses at~     a 56‐day interval versus the same regimen with the recently released batches of Ad26.ZEBOV~     and MVA‐BN‐Filo in terms of humoral immune response against the Ebola virus (EBOV) GP~     (glycoprotein) as measured by enzyme‐linked immunosorbent assay (ELISA) at 21 days post~     boost.~   "
78191|NCT02543554|"~     Early mechanical ventilation, if delivered with injurious settings, can lead to pulmonary~     complications, such as acute respiratory distress syndrome (ARDS). Mechanical ventilation in~     the emergency department (ED) has been studied infrequently when compared to the intensive~     care unit; however, data suggests that ED-based mechanical ventilation has significant room~     for improvement and may also be a causative factor in ARDS incidence.~   "
78192|NCT02543541|"~     The goal of this research study is to find out if providing patients who are enrolled in~     phase 1 clinical trials with structured supportive care will enable them to continue in the~     Phase 1 trial longer and improve their quality of life by reducing or treating side effects~     and by providing emotional and social support to the patient and family. The structured~     supportive or palliative care intervention will be provided by a team of trained specialists~     which include doctors, nurses, social workers and spiritual care providers. The supportive~     care team will provide treatment to address symptoms, such as pain or anxiety, caused by the~     cancer itself or from the treatment. The team can make referrals to other specialists. Such~     as psychologists or nutritionist, if needed, and can help arrange for services to address~     home care needs.~   "
78193|NCT02543528|"~     This study is a prospective, randomized, double-masked, bilateral, dispensing, parallel-group~     clinical trial design. All subjects will participate in a 2-week daily disposable contact~     lens adaptation period prior to being randomized into one of the four extended wear lenses.~     The study has a total of 9 scheduled study visits and a total duration of ~197 days. The~     lenses will be replaced with a fresh pair after 6 nights / 7 days of wear.~   "
78194|NCT02543515|"~     Study type:~      Observational, prospective.~      Objectives:~      Primary:~      Identify psychosocial and clinical factors that predispose to the occurrence of pain~     following office hysteroscopy~      Secondary:~      Stratify risk factors for pain previous Cesarean section and pain score repeat C section and~     pain score post-menopausal and pain score type of delivery and pain score body mass index and~     pain score history of dysmenorrhea and pain score, abnormal uterine bleeding and pain score~     previous surgery upon uterine cervix and pain score Characterize women's psychosocial profile~     and pain score Establish anxiety as a factor influencing pain perception using (State-Trait~     Anxiety Inventory for Adults).~      Determine if there is a specified population who would benefit from procedure under~     anaesthesia~   "
78195|NCT02543502|"~     The main objective of this study is to evaluate the effect of treatment periodontal~     endothelium-dependent artery of the arm in patients with acute myocardial infarction with~     ST-segment elevation undergoing primary coronary intervention.~   "
78196|NCT02543489|"~     The purpose of this study is to compare the effect of post-operative ROM between Flex IM rod~     and Rigid IM rod, to collect bone morphology of Japanese lower extremity and to research the~     incidence of overhung with Flex IM rod.~   "
78197|NCT02543476|"~     This is a retrospective international, multi-center, non-interventional cohort study based on~     use of data derived from established medical records and secondary analysis of archival tumor~     samples. The study will collect data on patient and tumor characteristics, PD-L1 status,~     patterns of treatment, and clinical outcomes, in up to 600 adult patients with~     recurrent/metastatic SCCHN. SCCHN of interest for this study are defined as the diseases~     falling into specific ICD-10 or International Classification of Diseases, Ninth Revision~     (ICD-9) codes (Table 1), depending on anatomical sub-site of the primary tumor.~      For patient selection, the date of diagnosis of recurrent/metastatic disease will be used as~     the index date. The patient selection period extends from the 1st March 2011 to the 30th June~     2015. This allows for the inclusion of patients with tumor samples of approximately ≤ 5 years~     age, and ensures approximately 10 months follow-up for living patients recruited at last day~     of the enrollment window. All patients with a diagnosis of recurrent/metastatic SCC of the~     oral cavity (tongue, gum, floor of mouth, and other/unspecified part of the mouth),~     oropharynx, hypopharynx, or larynx during that period will be considered for inclusion in the~     study (Figure 1). Patients will be identified and followed up through their medical records~     until death or end of data collection in approximately 20 centers in the US, Asia and Europe.~      Patients' demographic, clinical characteristics, and medical history will be described.~     Clinical outcomes including PFS, best response, duration of response, and ORR will be~     described for the first line and second line of therapy (if any), and OS will be collected A~     mandatory archived tumor samples will be used to determine PD-L1 status. If a patient has~     more than one suitable tissue sample, the most recent sample will be used as the mandatory~     tissue sample. Where available, additional tumor samples obtained at any other time points of~     the disease will be also collected (optional).~      The enrolment target is up to 600 patients. Statistical analyses will be performed for the~     whole cohort, per PD-L1 status and for predefined subgroups.~   "
78198|NCT02543463|"~     The purpose of this study is to compare the effect of the large head in THA with a navigation~     system and without a navigation system.~   "
79754|NCT02523027|"~     This study will investigate the effect of two oral nutritional supplements (ONS) along with~     dietary counseling vs dietary counseling alone on growth among picky eating children from~     India, aged > 24 months to ≤ 48 months over a period of 90 days.~   "
78200|NCT02543437|"~     The purpose of this study is to explore the benefit of X3 polyethlene inserts with larger~     diameter heads used in the Japanese population. Range of Motion (ROM) and lift-off distance~     for both 28mm, 32mm and 36mm in patients will be examined intraoperatively by using the~     Stryker computerized tomography (CT) based Navigation system. Another aspect of this study is~     to observe wear resistance performance of X3 over historical liner existing highly~     crosslinked polyethylene.~   "
78201|NCT02543424|"~     Neurological pathologies cause important and permanent disabilities in every day life. These~     pathologies can follow stoke, affecting two people per one thousand each year or cerebral~     palsy, affecting two births per one thousand each year. To date, the diagnosis and the~     rehabilitation of motor and cognitive problems has been carried out separately by different~     domains. For example, physiotherapists have focused on motor problems and neuropsychologists~     have focused on cognitive functions. However, a number of studies have demonstrated a link~     between motor and cognitive abilities in adults and children. The present study has three~     main aims: (1) to better evaluate motor and cognitive problems in brain damaged patients (all~     ages), (2) to understand the link between motor and cognitive abilities in patients and~     healthy participants and, (3) to propose new types of therapies based on the link between~     motor and cognitive functions.~   "
78202|NCT02543411|"~     The primary purpose of this study is to investigate the effects of lidocaine on the total~     administered dose of fentanyl during sedation for endoscopic mucosal resection.~      The secondary purpose of this study is to investigate the effects of lidocaine on pain score~     related with endoscopic mucosal resection at time of 30 min, 6 hr, and 24 hr after procedure.~   "
78203|NCT02543398|"~     Following tooth extraction ridge preservation procedure have been suggested to limit bone~     resorptive dimensional changes to facilitate prospective implant placement. While this is~     particularly true for anterior teeth, no evidence is available to establish clinical~     guidelines in posterior sites, i.e. following molar extraction.~      This research project will answer the following question:~      What are the dimensional changes of the hard and soft tissues encountered following molar~     extractions with and without ridge preservation?~   "
78204|NCT02543385|"~     This study investigates the effect of low dose S+ketamine compared to placebo on cumulative~     morphine consumption at 24 hours in women undergoing open abdominal hysterectomy with~     remifentanil-propofol target controlled infusion. It compares the adverse effect profile in~     patients receiving S+ketamine as compared to those who did not. Participants are randomly~     distributed in two groups of 45 patient's each.~   "
78205|NCT02543372|"~     Background: Problem gambling is a public health concern with prevalence rates at 2 %. Problem~     gambling also severely affects concerned significant others (CSOs). Several studies have~     investigated the effects of individual treatments based on cognitive behavior therapy (CBT),~     but there is a shortage in studies on the effect of involving CSOs in treatment. This study~     aims to compare an intervention based on behavioral couples therapy (BCT) involving a CSO~     with an individual CBT treatment to determine their relative efficacy. BCT has shown~     promising results in working with substance abuse, but this is the first time it is used as~     an intervention for problem gambling. Both interventions will be Internet-delivered and~     participants will receive e-mail and telephone support.~      Method/Design: A sample of at least 100 couples will be randomized to either the BCT~     condition or the CBT condition. The participants will work through 10 modules over 12 weeks~     in a secure online environment, and receive support via email and over telephone. Repeated~     measures will be conducted weekly and at 3, 6 and 12 months follow-up. The primary outcome~     measure is gambling behavior, defined as time spent and money lost on gambling, as measured~     by timeline follow-back. Secondary outcomes include gambling related harm, alcohol~     consumption, relationship satisfaction and mental health for the gambler as well as for the~     CSO.~      Hypotheses: The investigators hypothesize that a) BCT will yield greater reductions on~     gambling measures than CBT, b) BCT will yield a lower drop-out rate compared to CBT, c) BCT~     will be superior to CBT on increasing relationship satisfaction, d) relationship functioning~     will mediate change in gambling behavior in the BCT group and e) reduction in gambling~     behavior will mediate change in relationship functioning in the CBT group.~   "
78206|NCT02543359|"~     Evidence-based treatments (EBTs) are available for treating Disruptive Behavior Disorders (~     DBDs) including Parent-Child Interaction Therapy (PCIT). Despite EBTs' potential to help~     children and families, they have primarily remained in university settings. Recognized field~     leaders have expressed concern over the discrepancy between treatment research and clinical~     practice, and have indicated that EBT implementation is a priority. Little empirical evidence~     exists regarding how effective commonly used training models are in changing clinician~     behavior, achieving full implementation (e.g., increasing treatment fidelity, integrating~     into service settings), and supporting positive client outcomes. This novel application will~     evaluate the effectiveness of three training models (Learning Collaborative,~     Train-the-Trainer, and Web-Supported Self-Study) to implement a well-established EBT in~     real-world, community settings.~      To accomplish this goal, the project will be guided by three specific aims:~        1. to build knowledge about training outcomes,~        2. to build knowledge about implementation outcomes, and~        3. to understand the impact of training clinicians using LC, TTT, and SS models on key~          client outcomes.~      Seventy-two of 243 possible (30%) licensed psychiatric clinics across Pennsylvania will be~     randomized to one of three training conditions:~        1. Learning Collaborative (LC),~        2. Train-the-Trainer (TTT), or~        3. Web-Supported Self-Study (SS).~      Data also will be collected on staff trained by clinicians in the TTT group given that the~     intention of a TTT model is for participants of that group to return to their organization~     and train others within the organization. The impact of training (clinician level) will be~     evaluated at 4 time-points coinciding with the training schedule: baseline, 6, 12, and~     24-months. Immediately after training begins, parent-child dyads (client level) will be~     recruited from the caseloads of participating clinicians (N = 288). Client outcomes will be~     assessed at four timepoints (pre-treatment, 3, 6, and 12-months). Implementation outcomes~     (clinic level) will be assessed at baseline, 6, 12, and 24-months after training. This~     proposal builds on an ongoing state-led initiative to implement, and ultimately sustain, PCIT~     statewide. Lessons learned from this project will directly impact future EBT implementation~     efforts in Pennsylvania and other states, helping to increase the use of EBTs in community~     settings nationwide.~   "
78207|NCT02543346|"~     Allergen challenge facilities have been utilized for many years in clinical drug trials~     studying onset of action, proof of concept, duration of action, and efficacy. Each facility~     has somewhat different design characteristics and pollen dispersal technologies. Facilities~     are located in disparate geographic areas and have populations of participants who are~     sensitized to allergens unique to that area. Therefore, facilities have operated as single~     sites with little effort to evaluate facility comparability or to attempt standardization~     across facilities. The purpose of this study is to compare the two sites and assess whether~     the sites are able to achieve similar symptom scores.~   "
78208|NCT02543333|"~     Validation of Structured Light Plethysmography (SLP) in patients with asthma, in patients~     with acute asthma; an observational study in healthy participants and during patients'~     clinical investigation of broncho-reversibility in the asthma groups.~   "
78210|NCT02543307|"~     Objectives: This quasi-experimental pre-post-study investigated the effect of newly developed~     Nurse-led Patient Pathways (NPP) designed to improve patients`, and health care~     professionals` as well as institutional outcomes.~      Intervention: In the IG patients were cared for under the three newly developed NPP. NPP are~     characterized by four principles: evidence-based nursing, patient and family centered care,~     comprehensive discharge planning beyond hospital discharge and nurses' responsibility for~     patients` processes. The principles support and strengthen patient and family preferences as~     well as formalize nursing activities, and therefore contribute to process transparency in~     relation to other health care professionals.~      Outcomes: Primary Outcomes were defined as quality of nursing care (nursing care index, NCI),~     and patient satisfaction (patient satisfaction with nursing care quality, PSNCQ). Secondary~     outcomes were defined as 1) nursing work environment (nursing work index revised, NWI-R; and~     nursing workplace quality, NWQ), and 2) institutional-related costs (length of hospital stay,~     LOS; nursing time and nursing costs). Additionally, nurses` and other health care~     professionals` experiences of intervention translation will be explored.~   "
78211|NCT02543294|"~     The goal of this clinical trial is to learn if heart function remains normal after stopping~     heart failure medication in patients who have received chemotherapy.~   "
78212|NCT02543281|"~     The purpose of this study is to better understand how adaptive cardiac resynchronization~     therapy (aCRT) might benefit patients. aCRT works by sometimes giving stimulation to only the~     left side of the heart, rather than to both sides, depending on how it senses the heart is~     functioning. CRT without the adaptive algorithm works by giving stimulation to both sides of~     the heart. aCRT has already been approved by the FDA and is being used in patients now, but~     it is not clear which patients it should be used in compared to normal CRT. This study will~     include patients who are already scheduled to get a CRT device. The investigators will then~     randomize patients to the aCRT study arm or to the CRT study arm. After 6 months, the~     investigators will assess the electrical activity of the patients' hearts. After this time,~     the patient and their doctors will be able to decide if they would like to change the type~     CRT they have been designated.~   "
78213|NCT02543268|"~     The purpose of this study is to compare the humoral immune response induced by 3 different~     batches of Ad26.ZEBOV as measured by enzyme - linked immunosorbent assay (ELISA) against the~     Ebola virus (EBOV) GP (Glycoprotein) at 56 days post prime.~   "
78214|NCT02543255|"~     This study evaluates the use of chemotherapy with cabazitaxel in addition to abiraterone~     acetate, prednisone, and leuprolide in neoadjuvant setting prior to radical prostatectomy in~     patients with high-risk prostate carcinoma. Half of the participants will receive treatment~     with abiraterone acetate, prednisone, leuprolide, and cabazitaxel, while the other half will~     receive only abiraterone acetate, prednisone, and leuprolide.~   "
78215|NCT02543242|"~     The rationale for the conduct of this study is that the Intone device (along with pelvic~     physiotherapy) can be used to help females suffering from urinary stress incontinence by~     using electrical stimulation and biofeedback during pelvic floor muscle training. This~     investigation is important because it can aid in the greater acceptance and development of~     non-surgical treatments for Stress Urinary Incontinence if these areas are looked into. The~     study results will address if the Intone device is beneficial and promotes long-term~     improvement in women that suffer from urinary incontinence.~   "
78216|NCT02543229|"~     The purpose of this first-in-human study is to evaluate the safety, pharmacokinetics (PK) and~     pharmacodynamics of OPT-302 administered as monthly intravitreal injections for 3 months with~     and without Lucentis™ in patients with wet age related macular degeneration (AMD). This study~     will be conducted in two parts: Part 1 will comprise an open label, sequential dose~     escalation and Part 2 a randomized dose expansion.~      OPT-302 is a soluble form of VEGFR-3 comprising the extracellular domains 1-3 of human~     vascular endothelial growth factor receptor (VEGFR)-3 and the Fc fragment of human IgG1. It~     functions by binding and neutralizing the activity of vascular endothelial growth factor~     (VEGF)-C and VEGF-D on endogenous VEGFR-2 and VEGFR-3.~      VEGF-C and VEGF-D promote blood vessel development (angiogenesis) by binding and activating~     VEGFR-2 and VEGFR-3. VEGF-C is also a potent inducer of vascular permeability or leakage.~     Angiogenesis and vascular leakage are key hallmarks of wet AMD. Approved therapies for wet~     AMD include Eylea™ and Lucentis™ which block the activity of VEGF-A, but not VEGF-C or VEGF-D~     which are alternate members of the same family of molecules.~      VEGF-C and VEGF-D can stimulate blood vessel growth and leakage through the same pathway as~     VEGF-A (via VEGFR-2), as well as through pathways that are independent of VEGF-A (via~     VEGFR-3). Published studies have also indicated that VEGF-C and VEGF-D play an important role~     in mediating resistance to therapies that block VEGF-A such as Lucentis™ and Eylea™.~      Combination therapy with OPT-302 an anti-VEGF-A agent provides a more complete blockade of~     the VEGF family. This strategy targets functional redundancy in the VEGF pathway and~     mechanisms of 'resistance' or sub-response to VEGF-A inhibition.~   "
78217|NCT02543216|"~     Interactions between genes and environment, are likely to be crucial in the development of~     the common diseases such as type 2 diabetes. It was recently shown that FADS1 and FADS 2~     genotypes are the strongest genes in a genome-wide analysis regulating serum fatty acid~     profile.The aim of this study is to test if subjects with the CC and TT genotypes of the~     FADS1 gene (rs174547) respond differentially to a diet supplemented with linoleic acid~     (substrate for FADS). We hypothesize that subjects with the TT genotype with more active~     desaturases will be more sensitive to dietary modification leading to more robust differences~     in serum FA profile, tissue inflammation and serum lipids.~   "
78218|NCT02543203|"~     Essential oils (aromatic oils extracted from plant parts) are routinely used by the public~     and are available on the market. Investigators are conducting this study because it is~     unknown whether the essential oils formulations will be safe and effective for improving~     quality of life in children with Autism Spectrum Disorder (ASD) by helping them relax and~     sleep.~      Children invited to participate in this study must be between 3-9 years of age and have been~     diagnosed with Autism Spectrum Disorder. Approximately 34 children and their families will be~     enrolled in the study.~      Participants will try two different fragrant oils in a double-blind randomized order. Each~     child will receive each treatment for 3 months, with a 1-month washout period in between~     during which no oil is used.~   "
78219|NCT02543190|"~     Short-term post-operative complications after colon and rectal surgery present a known major~     clinical and financial burden for patients and hospitals. Focused efforts to reduce~     readmissions after colorectal surgery is one potentially high-yield and broad approach to~     address this problem since post- operative complications are the strongest predictor of~     readmissions. We focus on decreasing readmissions after ileostomy surgery by using a~     previously published intervention that prevents dehydration in the outpatient setting and~     decreases acute renal failure complications. We plan to introduce the SWIFT post op program~     for ileostomy patients at one academic and two community hospitals which are part of a single~     health care system, and to then randomize patients to usual care in the setting of this new~     program versus an aggressive compliance surveillance and improvement strategy (CSIS) strategy~     using study personnel. Our primary study outcome is all-cause 30-day readmission, and our~     secondary outcomes include patient satisfaction (CAHPS scores) and a cost-benefit analysis.~     We seek to create a partnership between colorectal surgeons, inpatient nurse managers and~     wound ostomy continence nurses (WOCN) at the three sites, linking them with outpatient nurse~     practitioners and physician's assistants at the respective colorectal surgery clinics who~     facilitate care-transition after hospital discharge.~   "
78220|NCT02543177|"~     Aim of the study is the determination of the ideal timepoint for the treatment of patients~     with acute Non-ST-segment Elevation Myocardial Infarction (NSTEMI) and an acute or chronic~     kidney disease (CKD) with a GRACE score < 140. It should be determine if a prompt coronary~     angiography or the protection of the kidneys from the used contrast agent is more important~     for the outcome of the patients. Additionally it will be investigated if the ischemic~     precondition can help to prevent heart damages.~   "
78221|NCT02543164|"~     Objective of the study is to investigate the influence of beta-glucan enriched barley flour~     as constituent of bread on glycaemic response (GR) in healthy human volunteers. Glycaemic~     response will be measured as AUC of blood glucose after consumption of barley bread, and~     compared with white bread.~   "
78222|NCT02543151|"~     The purpose of this study is to describe SpyGlass choledochoscopy in patients with post~     orthotopic liver transplant (OLT) biliary strictures prior to endoscopic therapy and ductal~     changes after treatment stents.~   "
78223|NCT02543138|"~     Traditional closed thoracostomy exhibit certain shortcomings. Blind dissection is a lengthy~     process that is difficult for unskilled physicians, whereas the use of a traditional trocar~     is relatively likely to damage internal organs. In this study, investigators developed a new~     trocar and examined its usefulness.~   "
78224|NCT02543125|"~     To evaluate the efficacy and safety of nasal high frequency oscillatory ventilation(NHFOV) in~     preterms with respiratory disease syndrome(RDS) after extubation.~   "
78225|NCT02543099|"~     The purpose of this study is to assess the clinical efficacy and safety of policosanol on~     elderly patients with endothelial dysfunction~   "
78226|NCT02543086|"~     This is a single-center open label study conducted in multiple sequential cohorts using~     Induced Blood Stage Malaria infection in healthy volunteers to characterize the effectiveness~     of KAE609 against sexual and asexual blood stage forms of Plasmodium falciparum. This study~     is divided in 2 parts (Part A and part B). A total of 8 healthy volunteers per cohort will be~     enrolled. Based on the results of Part A, Part B will be undertaken to evaluate the effect of~     KAE609 following pretreatment with Piperaquine on sexual stage/gametocytemia and its activity~     as an inhibitor of onward transmission to mosquito vectors using experimental mosquito~     feeding assays.~   "
78227|NCT02543073|"~     Interstitial lung disease (ILD） is the late pulmonary complications after allogeneic~     hematopoietic stem cell transplantation (allo-HSCT) leading to high morbidity and mortality.~     At present, the treatment for ILD after allo-HSCT remains in discussion. In this study, the~     efficacy of mesenchymal stem cells (MSCs) combined azithromycin as well as glucocorticoid as~     the treatment of ILD will be evaluated in the recipients of allo-HSCT.~   "
78228|NCT02543060|"~     This study will evaluate the sensitivity of an assay and its ability to split a marketed~     stannous fluoride toothpaste versus a negative control.~   "
78229|NCT02543047|"~     Feasibility Study to Demonstrate the Safety of the Angioshield System to Provide Mechanical~     Support for Vein Grafts Used in CABG Surgery.~   "
78230|NCT02543034|"~     This study is a randomized, controlled, multi-centre, open-label, phase IV study.~      Total 81 patients will be enrolled in this study. Patients will be randomly assigned to~     Betafoam®, petrolatum gauze or Allevyn for donor site wounds after skin graft operation.~   "
78231|NCT02543021|"~     Patients with colitis require regular 'surveillance' colonoscopy as their risk of developing~     colon cancer is at least 2.5 times that of the general population. However, cancer in colitis~     develops as flat lesions called dysplasia, that can be easily missed at routine colonoscopy.~     As a result NICE guidelines for colitis surveillance recommend the use of a technique called~     chromoendoscopy (CE) in which a water-soluble blue dye is sprayed through the colonoscope to~     coat and highlight the lining of the bowel, making dysplasia easier to see. Although CE is~     accepted as best practice for surveillance it is time-consuming, technically difficult and~     requires expertise to interpret the appearances. For these reasons, its use is not widespread~     and the vast majority of patients still receive the inferior 'routine' colonoscopy without~     CE.~      New technology means that the video image obtained during colonoscopy can be digitally~     enhanced and coloured at the press of a button - termed virtual chromoendoscopy (VCE). This~     could make surveillance colonoscopy shorter, more comfortable and cleaner (resulting in a~     more 'dignified' experience) as well as cheaper and less technically difficult.~      The main objectives to be explored in this feasibility study (and the larger trial) were~     informed by a PPI meeting, which placed the ability to detect dysplasia at equal importance~     with the participant's experience of the procedure in terms of speed, comfort and dignity.~      This is primarily a feasibility study to assess patient experience, recruitment and retention~     rates to the investigators' specified trial design, to support the development of a larger~     crossover trial to compare VCE to CE during surveillance colonoscopy for colitis.~   "
78232|NCT02543008|"~     Comparison of the effects of physical activity (treadmill running) plus thoracic~     mobilization, physical activity only or a placebo intervention (only manual contact thoracic~     mobilization), on heart rate variability and pressure pain threshold.~   "
78233|NCT02542995|"~     The health of the public depends upon smoothly functioning physician offices that promote the~     health of both workers and their patients. This study targets ambulatory health care offices~     with rapid paced, chaotic environments. Investigators will measure adverse outcomes for~     providers and staff (e.g., stress and burnout), the impact these have on quality of care for~     hypertensive, diabetic and depressed patients, and identify areas where practice redesign to~     create healthy workplaces improves these outcomes.~   "
78234|NCT02542982|"~     This study investigated the combined effects of anodal tDCS and intensive motor training (MT)~     vs. sham stimulation with MT (control intervention) on grip strength, motor performance and~     functional use of the affected arm in population of chronic stroke patients.~   "
78235|NCT02542969|"~     The purpose of this study is to determine whether MGL-3196 alters the pharmacokinetics of~     rosuvastatin and/or simvastatin in healthy male subjects and female subjects not of~     child-bearing potential.~   "
78236|NCT02542956|"~     The purpose of this study is to identify the best pain management for patients undergoing~     abdominoplasty after massive weight loss or transverse rectus abdominis myocutaneous (TRAM)~     flap for breast reconstruction. The investigator is conducting this study to compare the~     effectiveness of a continuous infusion pain pump versus a locally injectable long-acting~     anesthesia (DepoFoam bupivacaine) versus standard injectable anesthesia (bupivacaine) for~     post surgical pain control. These drugs and devices are approved by the FDA (Food and Drug~     Administration) for the purpose of pain control after surgery, and have been used for this~     purpose before.~   "
78237|NCT02542943|"~     This study will investigate the longitudinal efficacy of two experimental oral rinses~     containing 1.5% weight/weight (w/w) dipotassium oxalate monohydride (KOX), formulated at pH~     4.5 and pH 7 respectively, for the relief of dentinal hypersensitivity (DH), compared to a~     placebo oral rinse, when used as an adjunct to twice daily brushing with a standard fluoride~     toothpaste.~   "
78238|NCT02542930|"~     Patients with Non-small cell lung cancer that had metastatic lesions after been treated with~     definitive surgery or chemoradiotherapy are being asked to participate in this study.~        1. To observe immunity-mediated tumor response outside the radiation field (abscopal~          effect) after chemoradiotherapy of a metastatic site in metastatic Non-small cell lung~          cancer patients.~        2. To induce the efficacy (effectiveness) of a new combination of therapy,~          chemoradiotherapy and thymalfasin for heavily pretreated, metastatic Non-small cell lung~          cancer patients;~        3. To explore the role of PET/CT scanning to assess tumor response/abscopal effect.~      This study will help find out what abscopal effects (good or bad) the combination of~     radiotherapy and thymalfasin has on metastatic Non-small cell lung cancer.~   "
78239|NCT02542917|"~     This trial will test, in a representative group of IBD patients, the acceptability of - and~     adherence to - the IBDoc test (a new home test for faecal calprotectin in the monitoring of~     inflammatory bowel disease (IBD)).~   "
78240|NCT02542904|"~     Crohn's patients receiving ileocolonic resection are randomized into extensive mesenteric~     resection group and local mesenteric resection group.~   "
78241|NCT02542891|"~     To compare the clinical impact and cost-effectiveness of blended Cognitive Behavioural~     Therapy (CBT) for adults with major depressive disorder (MDD) with treatment as usual (TAU).~     Within the French context the TAU is considered as the traditional face to face CBT.~   "
78242|NCT02542878|"~     This study evaluate the effect of the a low back self-application of myofascial release using~     a foam rolling on back muscles endurance measured by the Biering-Sorensen test.~   "
78243|NCT02542865|"~     This study will test the hypothesis that a fortified malt based food may improve immunity~     outcomes in 7-10 year old school age children.~   "
78244|NCT02542852|"~     Research ipotesis is to assess the efficacy and safety of a nucleos(t)ide sparing regimen of~     atazanavir/ritonavir 300 mg /100 mg QD + Dolutegravir 50 mg QD for the management of~     virological failure in HIV-1 infected patients.~      The Primary Objective is to explore the 24-week efficacy of a nucleos(t)ide sparing regimen~     of atazanavir 300 mg QD/ ritonavir 100 mg QD + Dolutegravir 50 mg QD for the management of~     virologic failure in HIV-1 infected, integrase inhibitor-naïve subjects.~   "
78245|NCT02542839|"~     Primary cervical dystonia (PCD) is the most common form of focal dystonia. PCD is frequently~     reported as a source of disability, decreased quality of life, and social stigma. Botulinum~     toxin (BoNT) is the gold standard treatment for PCD. The average duration of benefits from~     BoNT injections was about 9.5 weeks and BoNT treatment is known to provide only pure~     symptomatic benefits and does not seem to modify the disease pathophysiology.~      The investigator plans to use repetitive transcranial magnetic stimulation (rTMS) therapy as~     an adjunctive therapy in combination with BoNT injections as a novel approach to treat PCD.~     The primary goal of this study is to compare standard treatment with BoNT versus BoNT~     combined with a two week course of rTMS.~   "
78246|NCT02542826|"~     This is a multi-site collaborative study that will be done in the context of three Quebec~     hospitals' outpatient pulmonary rehabilitation programs: Montreal Chest Institute; University~     of Laval, and Hopital Sacre-Coeur Montreal. The objectives are two-fold. First, to determine~     the Minimal Clinical Important Difference in intensity ratings of perceived breathlessness~     for each of the 3-min constant rate shuttle walking (3-MWT) and stair stepping (3-MST)~     protocols in patients with chronic obstructive pulmonary disease (COPD). Second, to test the~     hypothesis that both the 3-MWT and 3-MST protocols are able to detect statistically~     significant and clinically-meaningful improvements in exertional breathlessness following an~     7-12 week outpatient rehabilitative exercise training program in COPD.~   "
78264|NCT02542592|"~     The study evaluates the pathophysiological effects of a single dose Methylprednisolone~     administered prior to total hip-arthroplasty (THA) surgery. The investigators examine the~     effect on immune signaling and recovery after surgery.~      Half of participants will receive intravenous Solu-Medrol 125 mg, while the other half will~     receive placebo.~      The investigators hypothesize that the group receiving Methylprednisolone will experience a~     positive modulation of the immune response and an enhanced recovery.~   "
78309|NCT02541994|"~     Patients in for treatment of benign intracranial hypertension will undergo two tests that are~     not routinely performed for these patients: central corneal thickness and axial length of the~     eye. The data obtained from these measurements will be assessed to see if the correlate with~     aspects of vision loss including visual acuity, visual field status, optical coherence~     tomography (OCT) results, and fundus photographs.~   "
78247|NCT02542813|"~     Intramuscular (IM) oxytocin is the gold standard prophylactic therapy for post partum~     haemorrhage (PPH). However, in resource-poor settings within the developing world, the~     stability and therefore effectiveness of prophylactic IM oxytocin is diminished by a lack of~     appropriate refrigeration facilities and availability of trained health care professionals~     (HCPs) to administer IM injections. This study will be the first investigation of oxytocin in~     humans via the inhaled (IH) route and is designed to evaluate the safety and tolerability of~     inhaled oxytocin and the five non-pharmacologically active components in the placebo, and to~     establish the PK characteristics of up to four fixed escalating doses of inhaled oxytocin. In~     this single blind ascending dose-escalation study, the systemic exposure from up to four~     proposed escalating inhaled fixed-dose levels (50 micrograms [mcg], 200 mcg, 400 mcg and 600~     mcg) will be compared with the systemic exposure following 10 international units (IU) of IM~     oxytocin in healthy premenopausal females.. A total of 15 subjects will be enrolled after~     screening sufficient number of healthy female subjects and the subjects will be assigned to~     one of the two treatment sequences. The total duration of this study is approximately 20~     weeks.~   "
78248|NCT02542800|"~     Schemas describe mental structures storing recurrent and organized pattern of information.~     Schemas may have a strong influence on the process of storing and retrieving new information~     into memory. Previous approaches in the cognitive neuroscience of memory have entirely~     focused on the individual dimension of preexisting schemas. In the real world though, much of~     the researchers' experiences and knowledge are collective or shared. Such social-cultural~     frameworks stored in collective memory may also reshape and reconfigure the construction of~     individual memories. Attempting to ascertain the influence of collective schema on the neural~     substrates of individual memories using cutting-edge brain imaging methods represents the~     challenge that MULTIBRAIN2 seeks to tackle. To achieve this goal, the researchers will record~     brain activity during MRI scanning sessions in a group of 24 participants while they are~     performing an encoding followed by episodic memory retrieval tasks on pictures of the World~     War II Memorial of Caen. This study will seek to identify brain areas of the prefrontal~     cortex encoding the organization of knowledge in collective memory using multivariate~     analyses of brain activity patterns, and then to understand how such regions might modulate~     the recruitment of the hippocampus during episodic memory retrieval using analyses of~     effective connectivity. The organization of knowledge in collective memory is measured in~     parallel through 1) the analysis of French social memory of World War II using a corpus of~     thousand of television and radio shows from the National Institute of Audiovisual, and 2) an~     internet task measuring the organization of shared individual knowledge about World War II.~     Once collected, these data will help us to understand how collective schemas may shape the~     organization of individual memories.~   "
78249|NCT02542787|"~     Phase II a Proof of concept study in Multiple Sclerosis (MS) patients with spasticity.~   "
78250|NCT02542774|"~     To evaluate the risk of cardiovascular events associated with medication use for controlling~     blood glucose, blood pressure and cholesterol levels in men and women with diabetes treated~     in primary care~   "
78251|NCT02542761|"~     The purpose of this study was to compare the functional performance of individuals with~     transtibial amputation using two types of prosthetic foot designs: carbon fiber vs.~     fiberglass composite.~   "
78252|NCT02542748|"~     Incidence of hypotension is high in parturients after spinal anesthesia. Ephedrine could be~     used to treat hypotension but lead to lower fetal pH as well. This study is to compare the~     effects of norepinephrine and ephedrine on hypotension in parturients.~   "
78253|NCT02542735|"~     Primary Objectives: To determine the incidence of type 2 diabetes in the south zone of the~     di@bet.es study (Andalusia and the Canary Islands) at 6 years follow-up. To determine the~     main risk factors associated with the incidence of type 2 diabetes and to check the role of~     diet and physical inactivity. To determine whether the interaction between diet fatty acids~     with the genetic variability of the fatty acid transport systems regulated by VEGFB influence~     the risk of diabetes and related diseases. To test in a general population the predictive~     value of some of the risk scores currently available: Finrisc, PREDIMED-clinical Score, etc..~      Secondary Objectives: To determine the incidence of obesity and metabolic syndrome in the~     south zone of the di@bet.es study. To determine the main risk factors associated with the~     incidence of obesity and metabolic syndrome: to check the role of diet, physical inactivity~     and certain polymorphisms in genes related to the handling of fatty acids Methodology:~     Prospective population-based cohort study where the incidence of type 2 diabetes, obesity and~     metabolic syndrome at 6 years follow-up will be determined in the sampling south zone of the~     di@bet.es study (1600 subjects aged 18 years baseline data from a randomized cluster~     sampling). Considering follow up losses in 25%, statistical power to detect as significant a~     relative risk of 1.5 (incidence = 10/1000 person-years) is greater than 85% (alpha = 0.05).~     Risk factor / exposure: alterations in glucose estimated from the baseline surveys, the~     presence of insulin-resistance (HOMA) score Finrisk / PREDIMED-clinical Score / adherence to~     Mediterranean diet transport and metabolism of fatty acids and genotypes of genes involved in~     the handling of fatty acids. Covariates: all collected in the baseline study.~   "
78254|NCT02542722|"~     It will be selected 1274 subject older than 40 years of the population of Cabra in order to~     realize a sociodemographic and habits (toxic, food, of physical activity) survey. It will be~     realized a physical exploration including anthropometry, blood pressure, oral glucose~     tolerance test, blood extractions (basal and after 120 ' of the OGTT). Several biochemical~     determinations will be realized (p.e. marker of fat intake and marker of inflammation) The~     proposed intervention consists of a series of clinical visits and phone calls programmed with~     the aim to change the dietetic and physical activity habits of people. The Pizarra study~     (financed with other grants and realised with the same methodology) will be use as cohort~     control. Though the basic aim of the project is to achieve a reduction of the of diabetes~     incidence with a hygienic - sanitary intervention, the ambition of knowing the major number~     of possible factors that can participate in this process constitutes a complex project~     capable of analyzing the problem from diverse points of view. Endocrinologists (of two~     Andalusian hospitals), clinical biochemists, geneticists and dietitians they join in this~     project to approach an integral way the etiopathogeny of the diabetes type 2.~   "
78255|NCT02542709|"~     The purpose of this trial is to study the effect of noninvasive brain stimulation in adults~     with post-traumatic stress disorder.~   "
78257|NCT02542683|"~     1. Compare physical activity and cognitive functions between children having cardiac~          surgery with an age-matched group of children undergoing non-cardiac surgery, as well as~          otherwise healthy siblings or best buddies (or age and gender-matched children if no~          siblings or best buddies available) before surgery and after surgery or six months~          following initial assessment.~        2. Determine the effects of a structured physical activity program for 6 months following~          surgery on cognitive functions and adaptive behavior in children following congenital~          cardiac surgery.~        3. Determine the effects of a structured physical activity program for 12 months following~          surgery on cognitive functions and adaptive behavior in children following congenital~          cardiac surgery.~        4. We will perform exploratory analysis to determine whether any effects of a 12-months~          structured physical activity program on cognitive functions and adaptive behavior~          persist beyond 12 months after cessation of the program.~   "
78258|NCT02542670|"~     Colorectal cancers (CRC) are the third most common human malignancy, and are also the leading~     cause of cancer related deaths worldwide. Early detection of premalignant lesions such as~     adenomatous polyps has decreased the risk of CRCs; however, cases which are initially~     undetected and progress to advanced CRC with distant metastasis are still unfortunately~     incurable. The development of CRC is a complex and heterogeneous process arising from an~     interaction between multiple etiological factors, including genetic factors and environmental~     factors such as diet and lifestyle. The challenges are to understand the molecular basis of~     individual susceptibility to colorectal cancer and to determine factors that initiate the~     development of the tumor, drive its progression, and determine its responsiveness or~     resistance to antitumor agents. Next generation sequencing(NGS)-driven genomic studies are~     already reporting novel features of cancer genomes beyond the traditional mutational~     categories. Recent advance in sequencing technology has enabled comprehensive profiling of~     genetic alterations in CRC.These methods are facilitating an increase in the efficiency and~     resolution of detection of each of the principal types of somatic cancer genome alterations,~     including nucleotide substitutions, small insertions and deletions, copy number alterations,~     chromosomal rearrangements,DNA methylation sequencing such as bisulfite-sequencing and~     microbial infections. Besides the microsatellite instability (MSI), some researchers reported~     novel mitochondrial mutations in the cancer genomes. NGS technology will help the~     investigators for understanding of entire CRC genomes and the obtained knowledge will lead to~     a better diagnosis and personalized targeted therapeutics for CRC management~   "
78259|NCT02542657|"~     This phase I/II trial studies the side effects and best dose of clarithromycin when given~     together with ixazomib citrate, pomalidomide, and dexamethasone and to see how well it works~     in treating patients with multiple myeloma that has not responded to previous treatment.~     Biological therapies, such as clarithromycin, pomalidomide, and dexamethasone, use substances~     made from living organisms that may stimulate the immune system in different ways and stop~     cancer cells from growing. Ixazomib citrate may stop the growth of cancer cells by blocking~     some of the enzymes needed for cell growth. Giving clarithromycin with ixazomib citrate,~     pomalidomide and dexamethasone may be a better treatment for patients with multiple myeloma.~   "
78260|NCT02542644|"~     Fuchs endothelial corneal dystrophy (FECD) is a progressive disease characterized by the loss~     of endothelial cells, thickening of Descemet's membrane and deposition of extracellular~     matrix in the form of guttae. This result in failure of the endothelium to support corneal~     deturgescence leading to corneal edema. Affected patients complain about blurred vision at~     early stages of the disease which can progress to blindness. The pathophysiology of the~     disease is still unclear, but several studies point towards a genetic susceptibility.~     Additional risk factors that have been identified are female sex, smoking and older age.~      While for a long time penetrating keratoplasty (PKP) was the only therapy available for~     affected patients, in the recent years less invasive methods such as descemet's membrane~     endothelial keratoplasty (DMEK) have been developed. In DMEK, only the Descemet's membrane~     and the endothelium is removed and replaced with the corresponding parts from a donor's~     cornea. For FECD, this brings the advantage that only the diseased part of the cornea is~     replaced. Graft detachment has been identified as the main complication following DMEK.~      In the investigators' study, an ultra high resolution OCT system will be used to detect graft~     detachment in patients with FECD after DMEK. With this technique, even small detachments can~     be visualized. The area of graft detachment will be evaluated at predefined time points after~     surgery and correlated to visual acuity. A follow-up of one year will be performed in order~     to investigate the predictive value of graft adherence status at several time points for~     visual outcome.~   "
78261|NCT02542631|"~     To compare glycemic control and treatment satisfaction using a novel bolus insulin patch~     (Finesse) versus a pen for initiating and managing bolus insulin dosing in patients with T2DM~     not achieving glycemic targets on basal insulin with/without anti-hyperglycemic agents.~   "
78262|NCT02542618|"~     Background: Major depression is a common mental disorder with serious consequences. The~     societal costs of depression are high. Despite the existence of empirically-supported~     psychological therapies, many patients do not benefit from these treatments and relapse and~     recurrence percentages are high. Improvement of existing treatments or development of new and~     better treatments is badly needed. Inquiry Based Stress Reduction (IBSR) is a promising~     verbal therapy focusing on the inquiry of thoughts and could be a next step in improving~     psychotherapy for depression.~      Objective: The objective of the current study is to assess the effectiveness of IBSR.~     Research to date has shown that IBSR is effective in reducing symptoms of anxiety and~     depression. The investigators want to know if IBSR is more effective in reducing symptoms of~     depression than the best psychotherapeutic treatment for depression at this moment, cognitive~     behavioural therapy (CBT). The investigators' secondary objective is to know more about the~     underlying mechanisms of change of these therapies.~      Study design: A randomized controlled intervention study.~      Study population: 88 patients with a mild to moderate depression as their principal~     diagnosis.~      Intervention: IBSR or CBT~   "
78263|NCT02542605|"~     Phase I, Randomized, Parallel-group, Double-Blind, Placebo-Controlled, Single Dose Study to~     Evaluate the Blockade of CGRP Receptor by AMG 334 in Preventing PACAP-38 Induced~     Migraine-like Attacks in Migraine Patients.~   "
78297|NCT02542150|"~     This study plans to learn more about how alcohol and its metabolite, acetate, affect the~     brain.~   "
78265|NCT02542579|"~     Diagnostic tests for Helicobacter pylori infection consist of noninvasive tests (i.e., urea~     breath test, serum antibody, stool antigen, urine antibody) and invasive tests (i.e.,~     histology, Giemsa stain, Warthin-Starry stain, Gram stain, culture, rapid urease test).~      Discrepancies between the tests may occur, and further induce problems for the diagnosis and~     treatment for H. pylori infection.~      Various types of microbiota can live together in a human stomach, and can be diagnosed using~     16S ribosomal ribonucleic acid (rRNA) pyrosequencing analysis based on multiplex polymerase~     chain reaction (PCR) method.~      With the progress of gastric atrophy, the numbers of gastric microbiota may increase due to~     the low acidity of the intragastric condition.~      As a consequence, H. pylori are derived out the stomach, and may show a negative findings on~     the H. pylori assays.~      The aim of this study is to evaluate how the composition of gastric microbiota differ~     according to the H. pylori test findings.~   "
78266|NCT02542566|"~     To test using a randomised control trial, whether conservative rehabilitation and protected~     weight bearing versus early weight bearing and accelerated rehabilitation affects patient~     outcomes post microfracture surgery of the knee.~   "
78267|NCT02542553|"~     The purpose of this study is to assess microbiologic concordance rates between right- and~     left-lung bronchoalveolar lavage cultures from patients with suspected ventilator-associated~     pneumonia, identify predictors of concordance, and evaluate the impact of discordant~     microbiology on clinicians' ability to prescribe appropriate antibiotic treatments, the~     investigators conducted a prospective observational study in the general intensive care unit~     of a large university hospital.~   "
78268|NCT02542540|"~     Children with osteogenesis imperfecta are described as extremely sedentary and therefore~     fatigable, which strongly impacts their daily activities. The physical rehabilitation of~     these children is a fundamental aspect of treatment.~      It has been shown that playing Wii console causes the same increase in energy expenditure~     than practicing moderate exercise, while ensuring user safety. This type of physical exercise~     with this type of fun game console might have a role in the treatment of OI children on the~     physical side but also on the psychological side.~   "
78269|NCT02542527|"~     This study is an early (during the product development process) feasibility study. It shall~     evaluate the device design concept with respect to device functionality of a new fluid filled~     breast pump in a small number of subjects.~   "
78270|NCT02542514|"~     The study is an open label, prospective, multicenter, phase II study which aims to define~     ibrutinib efficacy in patients with relapsed or refractory primary central nervous lymphoma~     (PCNSL) or intraocular lymphoma (IOL) as measured by the disease control (DC) rate (complete~     response (CR) + uncertain complete response (Ru) + partial response (PR) stabilized disease~     (SD)) after 2 cycles of treatment according to International study group for PCNSL (IPCG)~     criteria.~   "
78271|NCT02542501|"~     The intention of this study is to investigate how many patients with prostate cancer, planned~     to be treated with LHRH analogues without history of surgery or radiotherapy, are suffering~     from LUTS. In addition the effect of LHRH analogues on the improvement of theses primary LUTS~     symptoms over time will be investigated.~   "
78272|NCT02542488|"~     This study evaluates the use of the STOPBANG questionnaire to predict whether an obese~     pregnant woman has obstructive sleep apnoea. All participants will have a STOPBANG score~     calculated and then be tested with overnight oximetry to see if they have obstructive sleep~     apnoea.~   "
78273|NCT02542475|"~     To assess the effects of daily LFMS treatments for those suffering from affective or anxiety~     symptoms. We hypothesize a reduction in affective and or anxiety symptoms after active~     treatment over the period of one week, with improvement through the following week.~   "
78274|NCT02542462|"~     This is a prospective randomized clinical trial that aims to evaluate the potential effects~     of the first dose of rotavirus vaccines on gastrointestinal motility and anatomy and blood~     and stool cytokine responses. It will also assess the association between these outcomes and~     the pattern of the shedding of vaccine strain rotavirus in the stool. Infants will be~     randomized to one of four arms: monovalent rotavirus vaccine (Rotarix®, RV1) alone, RV1 with~     other recommended vaccines, pentavalent rotavirus vaccine (RotaTeq®, RV5) alone, or RV5 with~     other recommended vaccines. Data derived from the pilot study will be used to assess the~     feasibility of conducting a larger scale study.~   "
78275|NCT02542449|"~     This study evaluates whether supplementations with a highly bioavailable green tea extract~     may help obese women to counteract weight regain after a 3-month weight loss intervention.~   "
78276|NCT02542436|"~     This study will focus on participants in the United Kingdom (UK) to collect local data on the~     effectiveness and safety of bevacizumab (Avastin) in the treatment of metastatic colorectal~     cancer in normal clinical use.~   "
78277|NCT02542423|"~     According to literature data, Endocan can detect the onset of respiratory failure. The~     investigators aim to prove its value also for cardiac surgery patients.~   "
78278|NCT02542410|"~     The proposed pilot study will estimate the efficacy and safety of a novel therapeutic agent,~     cabergoline, with a clinical standard therapy, norethindrone acetate, for the treatment of~     endometriosis-associated pain in young women with endometriosis.~   "
78279|NCT02542397|"~     About half of all cancer patients seen in oncology clinics have pain at initial assessment;~     pain relief within a one-month period is seen in approximately one third of these patients~     and pain worsening in about one fifth. Risk factors for under-treatment of cancer pain~     include age older than 65 years, minority status, and inadequate pain assessment practices.~     There is a need for better methods of opioid drug/dose selection and identification of risk~     factors for worsening pain. Pharmacogenomic approaches offer insight into the genetic~     variables that impact the pharmacokinetic and pharmacodynamic behavior of opioids.~     Translating pharmacogenomic results into actionable prescribing decisions may ultimately~     enable a personalized approach to pain management, increasing the chance of significant pain~     improvement. Cancer outpatients with uncontrolled malignant pain will be offered a~     pharmacogenomic test through participation in the study. The results of this test will be~     used to modify their pain regimen, if applicable.~   "
78310|NCT02541981|"~     The outcome of heart transplantation has improved by years. The renal dysfunction is a major~     complication after heart transplantation.The natural course of renal function following~     orthotopic heart transplant is not clear in Taiwan. A retrospective study was conducted on~     patients who received a heart transplant at National Taiwan University Hospital between 1987~     and 2015.~   "
78280|NCT02542384|"~     The study schedule is comprised of a 14-day Screening Period, a treatment period and an~     observation period. All eligible subjects will be randomized into one of 3 treatment groups~     (1 of 2 dose levels or matched placebo). Study drug CR845 will be administered intravenously~     prior to surgery, and at specific time intervals post surgery. Additional rescue pain and~     anti-nausea medication will be made available. Post surgical changes in pain intensity,~     nausea and vomiting will be assessed.~   "
78281|NCT02542371|"~     The purpose of this study is to measure arterial 99mTc-Tilmanocept uptake using single photon~     emission computed tomography (SPECT/CT) scanning in HIV infected subjects known to have~     subclinical coronary atherosclerosis as assessed by contrast-enhanced coronary computed~     tomography angiography (CCTA).~   "
78282|NCT02542345|"~     This is a prospective, multicentric study conducted in order to evaluate if MRI~     coronarography is as powerful as Cardiac Multislice CT in detection of coronary abnormalities~     after coronary reimpantation in children over 5 yo, teenagers and young adults who underwent~     coronary reimplantation in childhood.~      Newborns suffering from transposition of the great vessels who underwent at neonatal age an~     arterial switch operation (ASO) with coronary reimplantation, may develop in time with~     growth, stenosis, twist or elongation of the reimplanted coronary artery, which may cause~     myocardial ischemia. As well, aortic root surgery such as the Ross procedure and abnomalous~     coronary artery from pulmonary artery (ACAPA) reimplantation may lead to the same~     complications. Functional ischemic tests in a combination of three minimum are positive in~     only 75% of the cases . Silent ischemia due to coronary abnormality is to be detected in~     those patients.~      In those patients, coronarography was recommended to be performed at least at 7 and 15 yo,~     without any clinical symptoms . It has also been recommended to examine those patients at 5,~     10 and 15 yo as growth is the main cause for coronary abnormality development. Cardiac CT has~     been proven to be as efficient as coronarography to depict coronary reimplantation~     abnormalities .~      Due to the invasiveness of angiography and to the development of cardiac CT, in our~     institution, the attitude is to performed cardiac CT instead of angiography with the same~     frequency in our patients.~      Coronaro MRI has been established as a valid technique for evaluation of coronary arteries in~     patients after ASO .~      The aim of this study is to evaluate if non contrast 3D MR coronarography is as powerful as~     Cardiac Multislice CT for the depiction of coronary anomalies.~      All patients, with prior ASO, Ross or ACAPA reimplantation, refereed for cardiac CT and~     eligible for MRI, over 5yo are included in this prospective multi centric study.~      Both examinations are performed on the same day after informed consent, from the patient or~     from both parents if minor.~      Cardiac CT is performed according to the usual protocol in our institution, and MR coronaro~     angiography is performed as follow: excluding any contra indication to MR, the study requires~     one or two maximum 3D true FISP sequence without IV contrast injection, with cardiac gating,~     and free breathing.~      3D images are evaluated blinded to the results of cardiac CT by two senior radiologists, with~     at least 5 years of experience in MR and CT cardiac imaging.~      Comparison of the results is consolidated afterwards. Other elements evaluated are tolerance~     and feasibility of the examination.~      The study is designed for four years and benefits from a grant from the Assistance~     Publique-Hopitaux de Paris.~   "
78283|NCT02542332|"~     This study evaluates whether doctors are familiar with the statistical background of lung~     cancer screening.~   "
78284|NCT02542319|"~     Randomized placebo-controlled double-blinded interventional trial to investigate the effect~     of oral magnesium supplementation on vascular calcification in subjects with chronic kidney~     disease. We hypothesize that oral magnesium supplementation will reduce vascular~     calcification in subjects with chronic kidney disease while not decreasing bone mineral~     density.~   "
78285|NCT02542306|"~     Bleeding is a common complication of cardiac surgery, especially aortic arch surgery~     involving moderate hypothermic circulatory arrest. Fibrinogen concentrate is increasingly~     used to treat coagulopathic bleeding in cardiac surgery, although its effectiveness and~     safety are unknown.~      Fibrinogen concentrate was administered to 54 patients when the fibrinogen level was below~     1.5 g/L after protamine reversal. Additionally, 30 patients were enrolled as the~     non-FC-treated group.~   "
78286|NCT02542293|"~     This is a randomized, open-label, multi-center, global, Phase III study to determine the~     efficacy and safety of durvalumab + tremelimumab combination therapy versus platinum-based~     SoC chemotherapy in the first-line treatment of patients with epidermal growth factor~     receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type advanced or metastatic NSCLC.~   "
78287|NCT02542280|"~     The investigator suggests that local endometrial injury using pipelle catheter performed in~     the follicular phase (cycle day 5, 6 or 7) of the stimulation cycle may improve the pregnancy~     rates among patients undergoing intrauterine insemination.~   "
78288|NCT02542267|"~     The objective of the ISR 14-04 study is to evaluate post-market safety and effectiveness of~     GORE® VIABAHN® Endoprosthesis for treatment of In-Stent Restenosis of the Superficial Femoral~     Artery.~   "
78289|NCT02542254|"~     This study evaluates the addition of RPL554 to standard reliever medications for chronic~     obstructive pulmonary disorder (COPD). All patients will receive the same six treatments in a~     randomised sequence:~        1. salbutamol,~        2. ipratropium,~        3. salbutamol + RPL554,~        4. ipratropium + RPL554,~        5. RPL554~        6. Placebo~   "
78290|NCT02542241|"~     The purpose of this study is to determine whether hypertonic saline solution is effective in~     the resuscitation of traumatized patients undergone abdominal damage control surgery~     regarding early closure of the abdominal wall.~   "
78291|NCT02542228|"~     This research is being done to construct a survey questionnaire, a quality of life tool, to~     determine the health, well-being, ability to perform daily activities, and physical, social~     and emotional functioning in participants with primary immunodeficiency disorders (PIDD).~     This quality of life (QOL) tool will help physicians understand the effects of PIDD on a~     person's health. These quality of life surveys are important tools for physicians to measure~     outcomes for satisfaction and effects of treatment.~   "
78292|NCT02542215|"~     To evaluate the efficacy, safety, and pharmacokinetics (PK) of liquid cobiprostone in~     preventing oral mucositis, when administered topically to the oral mucosa via spray for the~     duration of radiation and chemotherapy (RT/CT).~   "
78293|NCT02542202|"~     This pilot clinical trial studies the side effects and best dose of stereotactic body~     radiation therapy in treating patients with kidney cancer that has spread to other places in~     the body (metastatic) or has come back (recurrent). Stereotactic radiosurgery, also known as~     stereotactic body radiation therapy, is a specialized radiation therapy that delivers a~     single, high dose of radiation directly to the tumor and may kill more tumor cells and cause~     less damage to normal tissue.~   "
78294|NCT02542189|"~     The purpose of this study was to collect data on the prevalence and clinical significance of~     elevated cardiac troponin in a large registry of unselected patients with atrial fibrillation~     presenting to an emergency department.~   "
78295|NCT02542176|"~     The purpose of this study is to evaluate the effects of both chronic and acute grape~     ingestion in a population of men and women at higher risk for both type 2 diabetes and~     cardiovascular disease (metabolic syndrome).~   "
78296|NCT02542163|"~     Purpose: To conduct a pilot study to assess the feasibility of the NimbleHeart wireless~     telemetry vest in cardiac rehabilitation.~      Study Design: This is a prospective, single center, non-randomized, pilot trial evaluating~     the NimbleHeart chest harness system.~   "
78298|NCT02542137|"~     Patients with small cell lung cancer that had metastatic lesions after been treated with~     definitive surgery or chemoradiotherapy are being asked to participate in this study.~        1. To observe immunity-mediated tumor response outside the radiation field (abscopal~          effect) after chemoradiotherapy of a metastatic site in metastatic small cell lung~          cancer patients.~        2. To induce the efficacy (effectiveness) of a new combination of therapy,~          chemoradiotherapy and thymalfasin for heavily pretreated, metastatic small cell lung~          cancer patients;~        3. To explore the role of PET/CT scanning to assess tumor response/abscopal effect.~      This study will help find out what abscopal effects (good or bad) the combination of~     radiotherapy and thymalfasin has on metastatic small cell lung cancer.~   "
78299|NCT02542124|"~     In the proposed study, NM-IL-12 will be evaluated as immunotherapy to increase antitumor~     efficacy against CTCL, while reducing skin-related toxicity, when combined with low-dose~     TSEBT therapy. Determination of the maximum tolerated dose (MTD) for NM-IL-12 is not planned~     in this study, rather, a pre-defined starting dose will be explored; this dose is based on~     two safety and tolerability studies of NM-IL-12 in healthy volunteers.~   "
78300|NCT02542111|"~     This study is to evaluate the efficacy and safety of Bortezomib plus GDP in the treatment of~     non-GCB DLBCL patients.~   "
78301|NCT02542098|"~     The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and effectiveness~     of Hydrocodone Bitartrate (HYD) tablets in children with moderate to severe pain requiring~     around-the-clock opioid analgesics.~   "
78302|NCT02542085|"~     Study is a prospective, multicenter, randomized trial evaluating two laparoscopic incisional~     hernia repair methods: basic laparoscopic mesh repair (lap.) and a hybrid repair~     (laparoscopic mesh and fascial suturation).~      Patients are recruited prospectively from 10 Finnish Hospitals (Oulu, Jorvi, Hyvinkää, Kotka,~     Seinäjoki, Valkeakoski, Lahti, Kuopio, Kokkola, Loimaa).~      Patients are randomized to operative groups (lap. vs hybrid).~      Follow-up visits are scheduled at 1- and 12-month after surgery. Patients are evaluated for~     their clinical status and an ultrasound scan is performed. QoL-questionnaire and pain score~     (VAS) are reported.~      The primary end-points:~        -  clinically and/or radiologically detected seroma in 1 month control~        -  clinically and/or radiologically detected recurrent hernia in 1 year control~      The secondary end-points:~        -  peri-and postoperative outcomes/ complications, morbidity, mortality~        -  duration of hospital stay~        -  pain scale (VAS)~        -  Quality of Life (SF/Rand36)~   "
78303|NCT02542072|"~     The purpose of this study is to compare the subjective performance of comfilcon A lens~     against samfilcon A lens after 4 weeks of reusable lens wear.~   "
78304|NCT02542059|"~     In order to evaluate the difference in beta cell mass in patients with and without complete~     resolution of type 2 diabetes mellitus (T2DM) after Roux en Y gastric bypass (RYGB)~     investigators aim to compare quantitative PET imaging of the pancreas between these patient~     groups.~      These highly relevant data will provide investigators with more information on the possible~     role of beta cell mass in the mechanisms behind resolution of T2DM after bariatric surgery.~     This would be of great interest for the assessment of RYGB as an alternative therapy in~     patients with T2DM with a BMI <35, who currently do not meet the international guidelines for~     bariatric surgery.~   "
78305|NCT02542046|"~     Although positive oral contrast agents are used for the majority of abdominopelvic CT scans~     in the United States, the quality of bowel opacification has not been compared between the~     three major classes of positive oral contrast material (barium sulfate, ionic iodinated~     contrast material, and non-ionic iodinate contrast material). This is a retrospective single~     institution study of clinical records to show whether the uniformity of bowel opacification~     is different between the three main types of positive CT oral contrast material used in the~     United States (Barium sulfate, Diatrizoate, and Iohexol). The investigators will~     retrospectively identify 250 patients each who received oral barium sulfate, diatrizoate, and~     iohexol for CT scanning of the abdomen and pelvis (total 750 patients) and assess the quality~     of bowel lumen opacification by the positive oral contrast agents.~   "
78306|NCT02542033|"~     Primary objective of this study is to investigate the effect of sugar reduction (starting~     from glucose and sucrose, respectively) on postprandial glycemic response to apple juice by~     comparing the reference food item apple juice (control) with the test product (apple juice~     with low sugar content) in male humans with impaired fasting glucose (IFG) (5.6-6.9mmol/l~     resp. 100-125mg/dL) (Kerner and Brückel, 2012 (DDG recommendation)) Secondary objective of~     this study is to investigate the effect of sugar reduction on postprandial insulinemic~     response.~      Exploratory objectives are to investigate further characteristics of postprandial glucose and~     insulin response and insulin sensitivity, gastrointestinal side effects and safety aspects.~   "
78307|NCT02542020|"~     Human immunodeficiency virus (HIV) infection is a major global health issue with up to 40~     million people infected worldwide. Due to highly active antiretroviral therapy, mortality~     related to acquired immunodeficiency syndrome (AIDS) has been reducing in the last decades.~     However, liver disease remains as an important cause of severe complications and death.~      Hepatic fibrosis progression is the main responsible for liver-related outcomes in~     HIV-positive patients. Co-infection by hepatitis B (HBV) or hepatitis C virus (HCV) is highly~     prevalence in HIV patients. Chronic viral co-infection induces faster liver fibrosis~     progression compared to mono-infected HIV. However, published data have been reporting~     presence of significant liver fibrosis in HIV without HBV or HCV infection. This might be~     related to direct action of HIV in hepatocytes or association with others factors, such as~     non-alcoholic fatty liver disease (NAFLD). NAFLD is associated with metabolic factors, such~     as obesity and type-2 diabetes mellitus. However, antiretroviral drugs may induce abnormal~     body fat distribution (lipodistrophy) and insulin resistance playing an important role on~     this process. Liver biopsy has been historically considered as the gold standard to evaluate~     liver injury. However, this painful method presents several limitations. Therefore, several~     non-invasive methods for estimation of liver fibrosis, such as biomarkers (APRI, FIB-4,~     FibroTest and FibroMeter) and transient elastography by Fibroscan, have been developed as an~     alternative to liver biopsy. The diagnostic performance and prognostic value of biomarkers~     and transient elastography have been validated in patients with chronic liver diseases.~     However, few data are available in HIV patients, especially in those without chronic viral~     co-infection.~      Therefore, patients, medical doctors and scientific community will be beneficiated by the~     future application of non-invasive methods for estimation of liver injury in clinical~     practice in HIV patients.~   "
78308|NCT02542007|"~     To evaluate the safety, efficacy and deliverability of the Combo bio-engineered~     sirolimus-eluting stent versus the Nano polymer-free sirolimus- eluting stents in the~     treatment of patients with de novo stenotic lesions of native coronary artery.~   "
78322|NCT02541825|"~     This study evaluates the incidence of hepatic encephalopathy between covered stent of~     diameter of 7mm and 8mm in TIPS(transjugular intrahepatic portosystemic stent shunt ).Half of~     the participants will receive stent of diameter of 7mm ,while the other half will receive~     stent of diameter of 8mm.~   "
78311|NCT02541968|"~     Randomized controlled non-inferiority trial comparing therapist-guided Internet-based~     Cognitive behavioral therapy (ICBT), self-guided ICBT, and individual face-to-face (f2f) CBT~     for Obsessive-Compulsive Disorder (OCD) in adults.~      The primary objective is to evaluate whether ICBT is a non-inferior treatment option compared~     to the best possible available treatment for OCD, individual face to face (f2f) CBT. A second~     objective is to compare the efficacy of self-guided vs. therapist-guided ICBT. As this~     question has cost implications for the health system, a third objective is to carry out a~     health economic evaluation of both forms of ICBT, in relation to the gold standard f2f CBT. A~     fourth objective is to explore whether ICBT is equally suited for clinic-referred cases~     compared to self-referred patients. Finally, a fifth objective is to investigate whether~     genetic markers, in combination with clinical variables, can be employed to predict treatment~     outcomes with CBT in general.~      Research Questions:~      Q1: Is therapist-guided internet-based CBT (ICBT) for OCD non-inferior to face-to-face (f2f)~     CBT with regard to OCD symptoms, function and quality of life?~      Q2: Is entirely self-guided ICBT non-inferior to f2f CBT with regard to OCD symptoms,~     function and quality of life?~      Q3: Is ICBT a cost-effective treatment, compared to f2f CBT?~      Q4: Is there a difference in treatment outcome between self-referred and clinical referred~     patients?~      Q5: Can clinical variables and genetic markers be useful to predict which patients will~     benefit from CBT?~   "
78312|NCT02541955|"~     This is a Rheumatoid Arthritis (RA) study. The purpose of this research study is to determine~     in RA flare, whether musculoskeletal ultrasound (MSUS) inflammatory scores and/or disease~     activity scores improve with Acthar treatment.~   "
78313|NCT02541942|"~     This study is conducted globally. This study describes pharmacogenetic testing of saliva~     samples from patients who participated in the NN1731-3562 trial (adept™2) (NCT01392547). The~     objective is to determine the HLA (human leukocyte antigen) type and polymorphisms in the~     FVII gene in patients previously exposed to rFVIIa analogue.~   "
78314|NCT02541929|"~     Docosahexaenoic acid (DHA) is an essential omega-3 fish oil. DHA is critical to the structure~     and function of brain cells.~      DHA fish oil has been shown to be beneficial in cognition in several animal studies; however,~     this effect in human studies is not clear. It is not known how much dietary fish oil can get~     into the human brain. Thus, exploring fish oil delivery in human brains is critical for~     designing appropriate interventions.~   "
78315|NCT02541916|"~     The purpose of this study is to validate and test a tolerance gene expression profile for the~     identification of operationally tolerant liver transplant recipients, allowing for the~     successful withdrawal of immunosuppression without rejection in these patients.~   "
78316|NCT02541903|"~     Penile squamous cell carcinoma (PSCC) is a highly aggressive and relatively rare disease.~     Supportive evidence for the value of systemic therapy does not exist for this disease and~     there are no agents currently approved by regulatory agencies. This study will evaluate the~     drug Gilotrif in patients with metastatic progressive PSCC following chemotherapy. Gilotrif~     has shown supportive evidence in non-small cell lung cancer by inhibiting certain proteins~     that are also found in PSCC. The drug has the potential for some patients to exhibit a~     response contributing to a greater quality of life.~   "
78317|NCT02541890|"~     Aim is to study the effect of a work place intervention during a multicomponent~     return-to-work rehabilitation program on return-to-work. The intervention is compared with~     inpatient rehabilitation only, and participants will be recruited from the diagnostic groups~     dominating the sick-leave statistics, namely musculoskeletal disorders, common mental~     disorders (e.g. stress, depression and anxiety), and unspecific disorders including chronic~     fatigue.~   "
78318|NCT02541877|"~     To observe the clinical outcomes of the different valve sizing strategies treating type-0~     Bicuspid Aortic Stenosis (BAS) with self-expandable transcatheter aortic valve implantation~     (TAVI) valve, compared with those of a standard sizing strategy of normal Tricuspid Aortic~     Stenosis(TAS).~   "
78319|NCT02541864|"~     According the Maastricht IV consensus report publish in the Gut 2012, bismuth containing~     quadruple therapy was suggested to be the first choice for eradication therapy of~     Helicobacter pylori in the area with high clarithromycin resistance. Whether hybrid therapy~     or 14-day bismuth containing quadruple therapy can replace standard triple therapy as the~     recommended first-line treatment is unknown. The investigators compared the efficacy of~     14-day hybrid therapy and 14-day bismuth containing quadruple therapy in first-line~     treatment.~   "
78320|NCT02541851|"~     The acute pain remains unfortunately a major health problem in intensive care patients.~     Several factors, such as cancer, traumatic injuries, surgery, scars, diagnostic or~     therapeutic procedure, could contribute to an increase in the incidence or in the intensity~     of acute pain. The acute pain could impact on the prognosis of intensive care patients and on~     the patients perception of the quality of care.~      Moreover, the acute pain could lead to a long-term chronic pain syndrome. The chronic pain~     after intensive care admission could threaten the physical and psychological recovery after~     the stay in the intensive care unit (ICU).~      If many studies have been conducted to improve the management of the acute pain in the ICU,~     only few data exist on the incidence and the risk factors of the chronic pain after a stay in~     a surgical intensive care.~      The aim of the DOLOCHROREA study is to assess the incidence and the risk factors of 6-month~     chronic pain after a stay in our surgical ICU.~   "
78321|NCT02541838|"~     Type 2 diabetes results in a host of neuromuscular, muscular, and autonomic system~     impairments that accelerate age-associated limitations in functional independence and the~     risk of falls. Diabetic peripheral neuropathy (DPN) contributes to functional declines in~     balance and mobility because of limitations metabolic abnormalities. The constellation of~     impairments accompanying type 2 diabetes diminishes muscle function and performance including~     strength and power. Loss of strength at higher speeds of movement (deficit in power) occurs~     in neural activation of muscles, changes in muscle properties, and through in older~     individuals with DPN compared to older controls. Consequently, this deficit in speed~     dependent muscle power production leads to limitations in rapidly responding to sudden loss~     of balance stability to prevent falling. The goal of this pilot research program is to~     determine the feasibility and effectiveness of a mechanism-based therapeutic intervention fro~     improving balance and mobility functions and preventing falls in older adults with DPN. The~     investigators pan to use the results from this pilot study to design and implement a larger~     randomized control trial.~   "
78323|NCT02541812|"~     The purpose of this study is two-fold: first, to observe the effect of one session of~     repetitive transcranial magnetic stimulation (rTMS) on the error-prediction abilities of~     patients with obsessive compulsive disorder (OCD) as well as healthy individuals; and second,~     to observe the clinical effect of 10 sessions of rTMS in patients with OCD.~   "
78324|NCT02541799|"~     The investigators hypothesis is that patient comprehension of telemedicine-enabled research~     informed consent is not inferior to standard face-to-face research informed consent.~      The procotol will involve a prospective, randomized control trial to test the effectiveness~     of a telemedicine medium in obtaining research informed consent. Within a single emergency~     department, the investigators will conduct a simple, low risk randomized trial (single does~     of oral chlorhexideine to prevent hospital acquired pneumonia among adult patients with~     expected hospital admission). Prior to being approached for informed consent, potential~     participants will be randomized in a 1:1 allocation ratio to standard face-to-face consent~     vs. consent provided by audio-visual telemedicine. After standard clinical care, potential~     participants will be approached according to their allocation. Comprehension of research~     informed consent will be the primary outcome, and will be measured using the modified Quality~     of Informed Consent (QuIC) instrument.~   "
78325|NCT02541786|"~     Dexlansoprazole MR is the R-enantiomer of lansoprazole that is delivered by a dual delayed~     release formulation. It is effective for symptom control of patients with gastroesophageal~     reflux disease. However, its efficacy in the treatment of H.pylori infection remains unclear.~     This study was conducted to investigate whether the efficacy of single-dose dexlansoprazole~     MR-based triple therapy was non-inferior to double-dose rabeprazole-based triple therapy in~     the treatment of H.pylori infection.~   "
78326|NCT02541773|"~     The purpose of this study is to understand the behaviour of certain blood markers in patients~     with heart failure who undergo a cardiac device implantation procedure called cardiac~     resynchronization therapy (CRT). CRT is an effective treatment for heart failure, but up to~     30% of people do not respond and have poor outcomes (1,2). Despite extensive investigation,~     identifying these patients continues to be a challenge. The study intends to describe the~     changes in these blood markers before and after CRT and to examine any potential clinical~     value.~      The idea behind the study is that these blood markers alter in heart failure and change with~     CRT implantation. Furthermore the pattern of marker expression before implant and after may~     predict response and outcome.~   "
78327|NCT02541760|"~     Otitis media is one of the most common infections among children and is a complication in~     about 30% of common colds. The most common complication of acute otitis media is otitis media~     with effusion. Some studies have reported the effects of montelukast and mometasone nasal~     spray in treatment of otitis media with effusion. However, current information is inadequate~     in this issue. The aim of this study was to compare the effectiveness of montelukast and~     mometasone nasal spray in treatment of otitis media with effusion in children attending~     Koodakan hospital in Bandar Abbas, Iran.~   "
78328|NCT02541747|"~     This study aims to evaluate the effects of aroma massage to sleep quality of the nurses and~     staff during night shift.~   "
78329|NCT02541734|"~     The highly promising and innovative tracer on 111In-DTPA-AHX-Lys40-Exendin 4 has been applied~     to determine beta cell mass in healthy volunteers and patients with type 1 diabetes. However,~     the high retention of the tracer in the kidneys was leading to a kidney/pancreas uptake ratio~     of 41±23. This high renal uptake is complicating absolute BCM quantification by SPECT~     imaging. In order to reduce the kidney/pancreas uptake ratio, investigators propose a~     co-infusion with the plasma expander Gelofusine since it has been shown in several~     pre-clinical and clinical studies that Gelofusine can reduce the renal retention of several~     other, closely related tracers. When investigators are able to reduce the kidney/pancreas~     uptake ratio, these findings will improve the interpretation of clinical quantitative SPECT,~     having important implications for therapeutic decision making for patients with diabetes,~     insulinomas or congenital hyperinsulinism, and may also have a major impact on our~     understanding of the pathophysiology of these diseases.~   "
78330|NCT02541721|"~     The current study aims to investigate the effectiveness in clinical symptomatic control and~     tolerability of LabiaStick#01 in women with symptomatic non-hypertrophic chronic vulvar~     dermatoses.~   "
78331|NCT02541708|"~     Intravenous iron preparations have been shown to be superior to oral iron and have largely~     replaced the treatment of anaemia in Northern countries. However, the socio-economic and~     medical conditions in low resource countries greatly differ from those in northern countries.~     Patients' different access to medication supply, perception of medication need and compliance~     as well as the burden of concomitant disease like malaria, soil-transmitted helminths,~     schistosomiasis, HIV and red blood cells (RBC) genetic disorders may influence effectiveness~     and safety of iron substitution modality. The aim of the present study is to compare iv iron~     substitution by ferric carboxymaltose (Ferinject®) to per oral iron substitution in a low~     resource country~   "
78332|NCT02541695|"~     Although the existing diarrhoeagenic Escherichia coli (E. coli) challenge model is already~     suitable for dietary interventions in its current form, further characterization of the~     working-mechanism of the attenuated strain and further optimization of the study design will~     enable the investigators to better select those ingredients that affect the key~     pathophysiological processes. The aim of the CORAL study is to further characterize and~     increase the discriminative power of the diarrhoeagenic E. coli challenge model.~   "
78333|NCT02541682|"~     In this study, the investigators aimed to research the relationship between affective~     temperament with the severity of the symptoms of nausea and vomiting in early pregnancy. The~     investigators aimed to assess temperament differences between healthy pregnant women and~     pregnant women suffering from mild, moderate, and severe hyperemesis gravidarum.~   "
78334|NCT02541669|"~     The purpose of this study is to assess the pharmacokinetics and safety of single- and~     multiple-dose of TAK-491 in healthy Chinese participants.~   "
78378|NCT02541084|"~     This study aims at investigation of the caregiver burden of Wet Age-related Macular~     Degeneration (wAMD) patients and at the assessment of how much of caregiver burden could be~     reduced in transitioning from Pro Re Nata to proactive therapy especially in real-life rural~     settings where public transportations are not readily available.~   "
78335|NCT02541656|"~     A goal-directed fluid management is definitely beneficial in high risk surgery. The fluid~     administration can be directed by cardiac output monitoring which evaluate the response to~     repeated fluid challenge or by preload dependence indices. These indices are not well~     validated in laparoscopic surgery while pneumoperitoneum can alter venous return or pulmonary~     compliance.~      The aim of the study is to study the validity of pulse pressure variation to predict fluid~     response under laparoscopic conditions and to describe the effect of the pneumoperitoneum on~     the dynamic preload indicators, i.e. the pulse pressure variation, the plethysmographic~     waveform of pulse oximetry variation and the stroke volume variation.~   "
78336|NCT02541643|"~     To provide elotuzumab treatment for single-patient use.~   "
78337|NCT02541630|"~     A variety of mindfulness-based interventions, such as Mindfulness-Based Stress Reduction and~     Mindfulness-Based Cognitive Therapy have been shown to be beneficial for individuals~     experiencing mood and anxiety symptoms. The aim of this pilot study is to test the~     feasibility of using a similar intervention, known as Big Mind, for veterans with PTSD and~     other psychological symptoms.~      Big Mind is a method of self-exploration that utilizes a voice dialog technique to help~     individuals see the world and themselves from a variety of perspectives. The investigators~     hypothesize that this process will increase mindfulness and decrease self-referential~     thinking, which is associated with negative affect.~      To test the feasibility of using this method, veterans with PTSD will complete a four-week~     group Big Mind class with a total of four sessions. The investigators will use a single group~     design with pre and post-intervention measures to assess tolerability and acceptance of the~     intervention. Secondary outcome measures will evaluate symptom improvement and increased~     mindfulness.~      If this project demonstrates that using this intervention for veterans with PTSD is feasible,~     then more rigorous clinical trials will be warranted.~   "
78338|NCT02541617|"~     Outcomes study to test the hypothesis that patients first identified by community-based~     neurologists, implanted by a networked movement disorders center, and then managed by the~     same community-based neurologist will have clinical outcomes comparable to movement disorders~     centers.~   "
78339|NCT02541604|"~     This early phase, multicenter, open-label, single-arm study will evaluate the safety,~     tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy of atezolizumab in~     pediatric and young adult participants with solid tumors for which prior treatment was proven~     to be ineffective.~   "
78340|NCT02541591|"~     The primary objective of the Neuroprotect trial is to assess whether or not a new goal~     directed hemodynamic optimization strategy can reduce cerebral ischemia in post-cardiac~     arrest (CA) patients.~   "
78341|NCT02541578|"~     Physiological complexity of gait, a measure of the interaction of multiple control mechanisms~     for walking within a biological system, is decreased in persons with chronic stroke compared~     to those without disability. Thus, it is assumed that the quantification of gait complexity~     represents the adaptability and health of the individual. However, it is unknown if the level~     of gait-related complexity improves over time with recovery from stroke. Therefore, the~     primary purpose of this study is to determine if the physiological complexity of gait changes~     over the first six months post stroke within the contemporary healthcare environment.~     Secondary aims include 1) determining if there is a difference between the amount of~     physiological complexity of gait and lateralization of hemispheric damage after stroke and 2)~     exploring the relationship of complexity to lower extremity motor impairment, walking speed~     and balance. Sixty individuals within one month post stroke from the greater Indianapolis~     area will be recruited for this prospective, longitudinal outcomes study. Testing sessions~     will occur at intervals across the first six months post stroke: within 1 month, at 3 months,~     and at 6 months post stroke. During each testing session, participants will complete a~     2-minute walking task during which accelerometer signals from wireless inertial measurement~     units will be collected and converted to sample entropy to quantify the physiological~     complexity of gait. Additionally, measures to quantify lower extremity motor impairment,~     walking speed and balance will be collected and analyzed. Changes in complexity of gait from~     early to later stages of stroke recovery may serve as a foundation for prognosticating~     outcomes, such as predicting capacity for community mobility and/or risk of fall. The~     proposed study will meet a critical need to develop methods that differentiate among~     capacities for adapting movement patterns in individuals with neurological dysfunction. This~     work will ultimately build upon evidence that will assist therapists in tailoring~     interventions in such a way to optimize function.~   "
78342|NCT02541565|"~     This pilot phase I trial studies the side effects of pembrolizumab and combination~     chemotherapy in treating patients with previously untreated diffuse large B-cell lymphoma or~     grade 3b follicular lymphoma. Monoclonal antibodies, such as pembrolizumab and rituximab, may~     interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy,~     such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone,~     work in different ways to stop the growth of cancer cells, either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab~     together with combination chemotherapy may be with a better treatment for diffuse large~     B-cell lymphoma or follicular lymphoma.~   "
78343|NCT02541552|"~     Adductor canal block is commonly offered to provide pain relief following knee surgery with~     the hope that they cause less leg weakness than traditionally performed femoral nerve block.~     Infrequently, adductor canal blocks also result in leg weakness thereby potentially limiting~     the advantages of the technique. Investigators want to find out the effective dose for a 30%~     response (volume of local anesthetic which would result in clinically significant weakness of~     the leg)~   "
78344|NCT02541539|"~     This project aims to study the benefits of probiotics namely Lactobacillus casei Zhang (LCZ)~     in prevention of upper respiratory and gastrointestinal illnesses, which are found common~     among adults in Malaysia aged from 18 to 81 years.~   "
78345|NCT02541526|"~     The purpose of this study is to evaluate tolerability, acceptability and potential efficacy~     of 4 months of maintenance treatment with Mirtazapine as compared to placebo for patients~     with co-occurring amphetamine-type stimulant and opioid dependence (COATS) receiving~     buprenorphine maintenance treatment (BMT) in Kota Bharu.~   "
78346|NCT02541513|"~     The proposed study will evaluate the tolerability, acceptability and potential efficacy of~     paliparidone for the treatment of co-occurring opioid and amphetamine-type stimulant (ATS)~     dependence. In the proposed clinical trial, all patients will first discontinue illicit~     opioid and ATS and be inducted onto buprenorphine maintenance treatment (BMT) in the~     inpatient ward at the department of psychiatry before beginning to receive paliparidone.~     Tolerability and acceptability will be evaluated by assessing the rates of patient retention~     during treatment, patient satisfaction with treatment and adverse effects during treatment.~     The potential efficacy of paliparidone will be evaluated with regard to the primary outcome~     measure: reductions in illicit ATS use, based on urine toxicology testing and self-report.~     Secondary outcome measures include treatment retention, reduction in HIV risk behaviors and~     improvements in functional status.~   "
78347|NCT02541500|"~     The proposed study will evaluate the tolerability, acceptability and potential efficacy of~     minocycline for the treatment of co-occurring opioid and amphetamine-type stimulant (ATS)~     dependence. In the proposed clinical trial, all patients will first discontinue illicit~     opioid and ATS and be inducted onto buprenorphine maintenance treatment (BMT) in the~     inpatient ward at the department of psychiatry before beginning to receive minocycline.~     Tolerability and acceptability will be evaluated by assessing the rates of patient retention~     during treatment, patient satisfaction with treatment and adverse effects during treatment.~     The potential efficacy of minocycline will be evaluated with regard to the primary outcome~     measure: reductions in ATS use , based on urine toxicology testing and self-report. Secondary~     outcome measures include retention, reduction in HIV risk behaviors and improvements in~     functional status.~   "
78348|NCT02541487|"~     This is a cross-sectional comparison study of three maternal and fetal groups. Patients~     studied are women (and their fetus if they conceive) participating in the Reproductive~     Medicine Network's (RMN) FIT-PLESE investigation (funded, the NuPA and PAo arms) compared to~     control mothers who decline the intervention protocols and their fetuses if they conceive.~   "
78349|NCT02541474|"~     There is an urgent need to develop new care models for patients with long-term and complex~     needs. Our goal is services that are seamless, pro-active and person-oriented.~      Intervention:~      The Patient-centered health care team (PACT) is a service model for frail elderly patients~     with multiple long term conditions. PACT is a seamless and proactive health service model~     that aims to ensure safe early discharge and prevent hospital admissions for elderly frail~     patients. The four pivotal elements are are supported by theoretical and empirical~     underpinnings: 1) Goal-oriented person centered approach 2) Inter-disciplinary comprehensive~     geriatric team: 3) Pro-active care plan.~      Study Objective:~      1) To investigate whether the PACT model improves health-related quality of life and patient~     generated goals 2) carry out a health economic evaluation of PACT.~      Design:~      The evaluation model for complex interventions is our guiding evaluation framework. This is a~     non-randomized, matched control, before after study. The intervention unit, is the care~     organization, including four hospitals - municipality dyads. Two intervention dyads and two~     control dyads. Index patients from intervention hospitals will be matched age, sex and number~     of chronic conditions.~      Intervention group: Patients with emergency admission to the UNN internal medicine department~     in Tromsø and Harstad who are age > 65, have three or more long-term conditions, an emergency~     admission within the last year, and an informed consent is given by patient or next of kin.~     (Approved by ethics board 07.05.2015). The exclusion criteria are: Language barriers, and~     less than 3 months life expectancy.~      Controls: Recruited from the Nordlanssykehuset (Bodø) and UNN-Narvik internal medicine~     departments, matched to the index patient's sex, age, number of long-term conditions. Control~     patients will be subject to the same data-collection as intervention patients.~      Data collections: All patient data will be collected at baseline, 6 and 12 months. Outcomes:~     The primary outcome is the adjusted differences in the change of Quality of Life, measured by~     Short Form-36 (SF-36), physical health dimension between intervention and control groups at 6~     months after inclusion in study.~   "
78350|NCT02541461|"~     Nutritional status including changes of body composition is one of the most important~     clinical determinants of outcome after gastrectomy for gastric cancer. The laparoscopic~     gastrectomy is considered to be minimally invasive and to have favorable outcome that is~     widely used in South Korea. It was reported that several advantages of laparoscopic~     gastrectomy are the prevention of overt weight loss and enhanced recovery of muscle mass at 6~     months after surgery. But there have been no longitudinal studies evaluating changes in the~     body composition according to the different type of anastomosis of laparoscopic gastrectomy.~      This study will therefore evaluate which of these two surgical procedures is most effective~     for postoperative body composition in laparoscopic gastrectomy patients, by comparing whether~     there are any differences in the amount of weight lost, lean body mass, fat mass, and lipid~     profile. It will help to better define the influence of anastomosis on changes of body~     composition after laparoscopic gastrectomy. This information can then be used by physicians~     to better make a plan to the patient's body make up and medical comorbidities.~   "
78351|NCT02541448|"~     This study is designed to evaluate physician preference related to the use of the SURGIQUEST~     AIRSEAL® INSUFFLATION SYSTEM (AIS) at low verses high pressure for the management of~     pneumoperitoneum.~   "
78352|NCT02541435|"~     In Europe, breast cancer is by far the most common form of cancer diagnosed in women today,~     accounting for 29% of all cases. The 5-year survival rate is approximately 90%. Surgery is~     usually combined with radiotherapy (RT), anthracyclines, aromatase inhibitors and/or~     trastuzumab (Herceptin) which all have improved the life expectancy and survival in breast~     cancer patients.~      Unfortunately, RT is associated with a broad spectrum of cardiovascular diseases, which~     includes coronary artery disease, valvular dysfunction, congestive heart failure and stroke,~     and is the most common non-malignancy cause of death. During the last two decades, RT~     regimens for breast cancer have changed and the doses of radiation to which the heart is~     exposed are now potentially lower due to new and improved RT techniques. However, there are~     no data on whether these new regimes decrease the risk of cardiovascular disease.~      In this study the incidence and prevalence of cardiovascular diseases will be estimated 8 and~     15 years after both conventional and laser assisted breath controlled RT, and compared with~     cardiovascular diseases in the general female population. A further aim is to evaluate signs~     and prevalence of acute cardiotoxicity from RT with the use of cardiac magnetic resonance~     imaging, coronary fractional flow reserve, ECG and inflammatory and cardiac biomarkers and to~     investigate whether these signs can predict later cardiovascular disease. The importance of~     traditional cardiovascular risk factors (age, hypertension, hypercholesterolemia, smoking~     habits and physical activity, as registered before RT) will also be evaluated.~   "
78353|NCT02541422|"~     This will be a double-blinded study involving healthy non-alcoholic (self-reported)~     volunteers over the age of 21 to consume beer on hospital property in a safe environment to~     ensure immediate availability to medical attention and to security if needed. Volunteers will~     be recruited from residency programs, hospital employees, emergency medical personnel, and~     friends of study investigators. The volunteers will drink to a BAC of 0.1 as checked with a~     breathalyzer. They will wear a tag around their neck with their study number, which will be~     hole-punched with every beer consumed, which will be collected at the end of the night for an~     accurate count of beers consumed per person. They however will not be forced to drink anymore~     if they are uncomfortable with the amount of alcohol they are consuming and can withdraw from~     the study at any time. All participants will be required to be driven home by a sober driver~     once the participant's BAT is 0.02 or less. At the end of the night, the volunteer will be~     breathalyzed to determine BAC, and given 1 capsule per 3 drinks consumed of either 600 mg~     N-Acetyl-L-Cysteine or placebo capsules. In the morning, each participate will fill out a~     Hangover Symptom Score questionnaire, evaluating each hangover symptom on a 0 - 4 point~     Hangover Symptom Severity scale. A random number generator will be used to determine Placebo~     or NAC first, then the participant will be given the other treatment at their subsequent~     encounter. The study will be conducted over the series of many months, and data can be~     analyzed by self-control comparing the participant's hangover symptom severity as determined~     by the hangover symptom scale data when using NAC compared to placebo. The data will be~     analyzed using the numerical values of each category for hangover classification and compare~     the placebo data to the control data.~   "
78480|NCT02539706|"~     This study evaluates the effects of rocuronium injection pain to menstrual cycle phases.Half~     of participants will receive follicular phase, while the other half will receive luteal~     phase.~   "
78354|NCT02541409|"~     The primary objective of this pilot trial is to evaluate the feasibility of 12 weeks vs. 24~     weeks of field-based directly observed therapy (DOT) for HCV therapy in a resource-limited~     setting. The investigators will compare treatment completion rates among 50 persons~     chronically infected with HCV who will be randomized to receive either 1) 12 weeks of~     sofosbuvir (SOF) + ribavirin (RBV) + pegylated interferon alfa-2a (PEG); or 2) 24 weeks of~     SOF + RBV. Treatment will be delivered daily by field workers at a location of a participants~     choosing. Secondary objectives are 1) To compare the efficacy of SOF+RBV with or without PEG~     as measured by the proportion of subjects with sustained viral response at 12 weeks after~     discontinuation of therapy (SVR12); 2) To evaluate the safety and tolerability of SOF+RBV~     with or without PEG; 3) To assess the impact of SVR12 on insulin resistance.~   "
78355|NCT02541396|"~     To evaluate the safety and effectiveness of Wafermine administered with and without an opioid~     medication for acute pain following bunionectomy surgery.~   "
78356|NCT02541383|"~     The purpose of this study is to evaluate if the addition of daratumumab to Bortezomib,~     Thalidomide and Dexamethasone will increase the stringent complete response rate after~     consolidation therapy and increase the progression free survival after daratumumab~     maintenance therapy in transplant eligible participants with previously untreated Multiple~     Myeloma.~   "
78357|NCT02541370|"~     RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory~     into patient autologous or donor-derived T cells may make the body build immune response to~     kill cancer cells.~      PURPOSE: This clinical trial is studying genetically engineered lymphocyte therapy in~     treating patients with Relapsed and/or Chemotherapy Refractory Advanced Malignancies.~   "
78358|NCT02541357|"~     This study aims to test the effects of a Preoperative Relaxation intervention and an~     Intensified Surgery Patient Education on pre- and postoperative wellbeing and health in~     Patients Undergoing colorectal surgery.~   "
78359|NCT02541344|"~     In this trial, the investigational product , the active ingredients which has been proven to~     reduce postprandial glucose in healthy and diabetic patients, will be tested. The primary aim~     of this clinical study is to evaluate the possibility of the investigational product to~     reduce the rise of postprandial glucose AUC level in overweight Caucasian subjects with~     normal to prediabetic biomarkers (IFG/HbA1C), without prompting a disproportionate rise in~     insulin levels.~   "
78360|NCT02541331|"~     This study evaluate the efficacy of Mechanical Bacterial Lysate (PMBL - Ismigen®) to improve~     the asthma control level (ACT score) as add-on treatment to routine asthma treatment in~     children aged 6 to 16 with uncontrolled or partly controlled asthma. Half of the 150~     participants will receive Ismigen® and their current asthma therapy while the other half will~     receive Placebo and their current asthma treatment.~   "
78361|NCT02541318|"~     Among health problems of peri-menopausal women, sleep disturbances is very common complaint.~     The aim of this study is to realize the body constitution of the peri-menopausal women with~     sleep disturbance; and to evaluate the effects of Duo-in practice on this population to see~     if this intervention can decrease the dosage of hormone replacement therapy.~      Quasi-experimental design and convenient sampling are both adopted. Participants will be~     recruited from China Medical University, Tri-Service General Hospital, Taiwan Society of~     Health Promotion, and Dr. Chen's Obstetrics and Gynecology Clinic. One hundred of~     participants who are willing to try Duo-in exercise to improve their sleep quality will be~     randomly assigned into experiment group and control group. The experiment group will practice~     Duo-in exercise 20 minutes every day for 2 months; while there is no intervention in the~     control group. Then, after 2 weeks, the participants of experiment and control group will~     crossover. The experiment group has no intervention, but the control group will practice~     Duo-in exercise for 2 months. Chinese version of the Pittsburgh Sleep Quality Index (CPSQI),~     Body Constitution Questionnaire (BCQ), peri-menopausal disturbance scale, and peri-menopausal~     fatigue scale will be used in the assessment at each time point. According to previous~     experience, a total of 70 participants will completed the whole observation course.~     Generalized estimating equations (GEE) is applied to analyzed the repeated measurement of~     different time and groups.~      This study will provide the evidence for Duo-in exercise as complementary treatment for~     hormone replacement therapy for peri-menopausal women, and also for integration of Dao-in~     exercise into mainstream treatment for other patients with sleep disturbance.~   "
78362|NCT02541305|"~     Knowing the effects of proprioceptive exercise program in improving balance, gait and risk of~     falls in institutionalized elderly.~   "
78363|NCT02541292|"~     Facioscapulohumeral muscular dystrophy (FSHD) is the second most common muscular dystrophy~     with approximately 500 patients in Denmark. It is characterized by weakness and wasting of~     the facial muscles, the muscles in the shoulder region and of the legs.~      The primary aim of this study is to investigate possible links and order between inflammation~     and fat infiltration in the muscles in patients with FSHD.~      Approximately 15 patients with FSHD will be recruited for repeated MRI-scans during a year~     where the inflammation and fat infiltration in the muscles can be quantified.~   "
78364|NCT02541279|"~     The investigators determined the effectiveness of a group intervention for the treatment of~     shoulder pathologies.~   "
78365|NCT02541266|"~     This research is aimed at finding out what may influence the decision of patients to~     participate in trials involving imaging so that the investigators may improve our future~     studies so they are more patient focused and acceptable in regards to scan schedules.~   "
78366|NCT02541253|"~     1. Part 1 If study subject and legal guardians who decide voluntarily to participate the~          clinical trial, and sign the Informed Consent Form (In the case of study subject less~          than 7 years of age, written informed consent by study subject's legal guardians), study~          subjects eligible for participating this trial protocol were assigned to test group and~          receiving the test drug 1 times or 2 times according to age.~        2. Part 2 If study subject and legal guardians who decide voluntarily to participate the~          clinical trial, and sign the Informed Consent Form(In the case of study subject less~          than 7 years of age, written informed consent by study subject's legal guardians), the~          study subjects eligible for participating this trial protocol were assigned to test~          group or control group with the ratio of 4:1 and receiving the test drug 1 times or 2~          times according to age as below;~             -  6 m ~ 3 years~             -  3 years ~ 9 years~             -  9 years ~ 19 years~   "
78367|NCT02541240|"~     Health professional students experience high levels of psychological stress. Individuals with~     higher levels of resilience are better equipped to handle stress. The purpose of this study~     is to evaluate the effects of an 8-hour resilience curriculum on stress levels, resilience,~     coping, protective factors, and symptomatology on students enrolled in a doctor of physical~     therapy (DPT) program.~      Hypothesis: The curriculum will decrease stress levels, increase resilience, coping~     flexibility, protective factors (optimism, positive affect, and social support), and reduce~     symptomatology (negative affect, illness). Research on stress and its consequences~     experienced by physical therapy students in particular is limited. If the results of this~     study support this hypothesis, it may establish the benefit of adding a resilience component~     to the curriculum for students of physical therapy.~   "
78368|NCT02541227|"~     Investigation of clinical practices, safety and effectiveness of Cerebrolysin in routine~     treatment of patients with acute ischemic stroke.~   "
78369|NCT02541201|"~     This is a randomized, double-blind, single-center, two-arm, placebo-controlled clinical trial~     that examine the effect of the consumption of a plant sterols-enriched low-fat milk. Half of~     the participants will consume of 1.5g of plant sterols daily as provided by two servings of~     the plant sterols-enriched low-fat milk product for 3 consecutive weeks, while the other half~     will consume placebo low-fat milk.~   "
78370|NCT02541188|"~     Breast cancer are common on mediterranean basin. Epidemiological data suggest that breast~     cancer in young women (< 40years old) is more aggressive in the Maghreb countries~     comparatively to western countries. This aggressiveness could be associated with phenotypic~     and genotypic differences between this two populations.~   "
78371|NCT02541175|"~     This study is designed to prove new methods to enable the automated analysis of esophageal~     electrocardiography (eECG) signals in long-term measurements as well as the detection of~     atrial fibrillation. The investigators hypothesis is that eECG signals allow the reliable~     atrial and ventricular ECG signal distinction and the detection of atrial fibrillation.~     Therefore 14 patients with arrhythmias and 6 cardiac healthy subjects are asked to take part~     in this study. On each subject an esophageal ECG and a simultaneous standard surface ECG will~     be taken for about half an hour. Patient undergoing a cardiac catheter ablation during their~     current hospitalization will be further asked to allow access to the invasively obtained~     measurements (i.e. atrial potential map) to further improve the understanding of the eECG~     signals.~   "
78372|NCT02541162|"~     In a perspective of improvement of the global care of the patients, investigators wish to~     estimate, within the oncology department of Paris Saint Joseph Hospital, the impact of a~     clear, written and oral information, on the sexual satisfaction of the couples during~     treatments.~      Further to this study, the project will be to train and to sensitize the medical staff, or~     still to develop new activities to meet the needs better of patients and of partners.~   "
78373|NCT02541149|"~     This study aimed to investigate the clinical utility of Annexin A2 serum level as a novel~     diagnostic marker of hepatocellular carcinoma (HCC) and to correlate its level with alpha~     fetoprotein the current marker ofhepatocellular carcinoma (HCC).~   "
78374|NCT02541136|"~     Stress-related disorders have a profound impact on public health. The World Health~     Organisation (WHO) found major depressive disorder (MDD) to be one of the most important~     human health problems with a prevalence of about 10%. In the current proposal the aim is to~     investigate mechanisms of resilience against stress-related disorders and to examine changes~     in quality of life, health, brain structure and brain function in individuals performing a~     resilience programme. Therefore, the investigators will recruit forty healthy subjects from~     the hospital staff exposed to normal day-to-day stress and not participating already in a~     fitness programme. Half of the subjects will be randomised to a cognitive behavioural~     self-experience and exercise programme for 20 weeks carried out by experienced supervisors,~     coaches and trainers. Clinical psychological and psychiatric examinations will be carried out~     weekly and a range of sophisticated neuroimaging techniques - high angular resolution~     diffusion imaging (HARDI) and functional MRI (fMRI) - will be conducted before and after the~     resilience program in order to investigate its effectiveness on brain structure and~     function. The stress system will also be tested by examining cortisol awaking response (CAR)~     and daily rhythms of cortisol secretion. These techniques are all well established in our~     laboratories. The proposed research will likely stimulate the development of new prevention~     strategies for this common and important disorder, and in the future could be applied to~     other illnesses. Moreover, when successful it could be patented and offered for~     implementation in the daily routine of median to large companies.~   "
78375|NCT02541123|"~     The primary objective of the clinical trial is to evaluate the effect of time on levels of~     Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP)~     biomarker levels in a population of head injured subjects over the age of 18 presenting~     acutely with a Glasgow Coma Scale score 13-15 as well as in a group of uninjured control~     subjects.~   "
78376|NCT02541110|"~     Second trimester homocysteine & uterine artery doppler will be assessed& the cases will be~     followed up till delivery for development of preeclampsia, IUGR(intra-uterine growth~     retardation) & other obstetric complications.~   "
78377|NCT02541097|"~     This study will establish factors fundamental to the improvement in communication and quality~     of life for people with dementia known as primary progressive aphasia (PPA). PPA is a type of~     dementia in which language declines but other cognitive skills (including memory) are~     preserved in the first several years after the onset. This makes those in the initial stages~     of PPA excellent candidates for treatment and creates a window of time (2-7 years) whereby~     they can lead independent lives with minimal support. However, currently, no communication~     therapy is available to people with PPA due to the progressive nature of the disorder and~     lack of awareness of available options for professionals willing to treat it.~      Participants with PPA in our study will receive two kinds of therapy for the words they~     cannot recall spontaneously, and will be trained to maintain them through social interaction.~     The type of training will be based on the most successful interventions the investigators~     provided to people with PPA in our previous work. The investigators expect that successful~     re-learning of forgotten words and practicing them in a group setting will facilitate~     retention of communication skills leading to greater personal independence and~     increased/maintained quality of life for people with PPA. Our study represents natural~     combination of two novel approaches for PPA that ultimately will lead to lower demands on the~     health care system.~   "
78379|NCT02541071|"~     Intrusive memories of traumatic events are core features of posttraumatic stress disorder~     (PTSD) but little is known about the neurobiological formation of intrusions. The aim of this~     study was to determine whether the activity of the noradrenergic system during an~     intrusion-inducing stressor influences subsequent intrusive memories.~   "
78380|NCT02541058|"~     This study is being conducted to develop and evaluate a cell-free fetal DNA test (Ariosa~     Test) for non-invasive prenatal detection of 22q11.2 chromosomal deletion or duplication.~     Investigators will be evaluating subjects with abnormal U/S.~   "
78381|NCT02541045|"~     The aim of this study is to evaluate the efficacy of metadoxine as a therapy for patients~     with biopsy-proven non-alcoholic steatohepatitis.~   "
78382|NCT02541032|"~     The PREMIERS study is a proposal for conducting an adequately powered two center phase III~     randomized controlled trial to test whether intensive periodontal treatment reduces the risk~     of recurrent vascular events among ischemic stroke and TIA survivors. The study uses the~     resources in both states including established dental centers, Joint Commission Certified~     Stroke Centers, the Schools of Public Health, and the Institute for Partnerships to Eliminate~     Health Disparities. The proposal addresses specific issues with regards to recruitment of~     African-American and rural stroke/TIA patients advocating the use of culturally appropriate~     strategies to educate the study subjects regarding stroke, periodontal disease and the~     periodontal stroke link.~      The study proposes to utilize economic evaluation of the periodontal intervention from the~     budgetary perspective. The focus will be on the financial sustainability of providing~     aggressive periodontal therapy (with certain, although relatively low expenditures) in~     exchange for a reduction of uncertain recurrent vascular events that may require high cost~     emergency department utilization and/or inpatient care. The sustainability of the proposed~     intervention after the completion of the project is integrally linked to the health economic~     assessment to show the health care cost savings. By integration with a rural primary care~     center, with an African American majority and households with average incomes below the state~     average, the study ensures that the proposed intervention to reduce stroke disparity is~     applicable to this target population.~   "
78383|NCT02541019|"~     Despite the development of new drugs, nausea and vomiting after surgery (PONV) are still~     frequent. Antagonists 5HT3 receptors, such as ondansetron and palanosetron, are among the~     main characterized prophylactic agents in patients at high risk, however there are few~     studies comparing the efficacy of these drugs and no study that addresses women aged over 60~     years.~      In this prospective, randomized, double-blind study, 80 women nonsmokers, undergoing~     laparoscopic cholecystectomy will be divided into two groups, receiving during anesthetic~     induction intravenous ondansetron 4 mg (n = 40) or palonosetron 75 mcg (n = 40) prophylaxis~     of PONV.~   "
78384|NCT02541006|"~     The objective of this study is to compare the bronchodilator efficacy a of tiotropium~     inhalation via DISCAIR (18 mcg once daily) and SPIRIVA HANDIHALER® (18 mcg once daily) in~     patients with moderate to severe chronic obstructive pulmonary disease (COPD).~   "
78385|NCT02540993|"~     The purpose of this study is to evaluate whether oral finerenone (study drug), in addition to~     standard daily therapy, is effective and safe in treating patients with type 2 diabetes~     mellitus and diabetic kidney disease, when compared to a placebo.~   "
78386|NCT02540967|"~     The objectives of this study are to investigate the safety and effectiveness of Gadovist.~   "
78387|NCT02540954|"~     To compare the efficacy of 2 mg aflibercept administered by two different intravitreal (IVT)~     treatment regimens to subjects with neovascular age-related macular degeneration (nAMD)~   "
78388|NCT02540941|"~     The investigators will extract single cells and analyze the molecular composition of single~     cells as well as bulks using the latest protocols for single cell and bulk genomics analyses~     including genetic, epigenetic, transcriptomic and proteomic analyses using the latest~     available protocols. A broad list of such example protocols are listed below.~      The samples and their molecular characterization (including sequencing & molecular levels)~     will serve as the basis for development of methods for single cells analysis. The developed~     methods are aimed at genomic transcriptomic, epigenetic, or proteomics analysis of single~     cells and share the same structure: the measured feature will be translated to a DNA library~     which will represent the feature by a dedicated assay.~      This library alongside with proper mathematical analysis of the sequencing results will be~     performed in order to conclude the desired feature. The general structure of such protocols~     is described in our review paper (Single-cell sequencing-based technologies will~     revolutionize whole-organism science, E. Shapiro, T. Biezuner & S.Linnarsson, Nature Reviews~     Genetics 14, 618-630, 2013) which is attached to our proposal.~      In addition, the researchers will use sequencing based methods (existing and future~     developed) in order to compare single cells and bulks from different tissues and/or different~     time points from the same donor in order to measure genetic, epigenetic, transcriptomic, and~     proteomic diversity.~   "
78389|NCT02540928|"~     The purpose of this study is to determine whether a drug called AMG 319 has an effect on a~     patient's own immune response to head and neck cancer squamous cell carcinoma (HNSCC). This~     study is specifically for patients who are having surgery to treat their HNSCC~   "
78390|NCT02540915|"~     The Chest Wall and Spine Deformity Registry is a tool designed to assist spine surgeons to~     efficiently identify and track patients with chest wall and spinal disorders.~   "
78391|NCT02540902|"~     This will be a prospective single cohort investigation of the Columbus all polyethylene tibia~     (Aesculap AG, Tuttlingen, Germany) used in total knee arthroplasty (TKA) surgery. The aim of~     the project is to determine post-operative outcome of the all polyethylene tibia up to two~     years.~   "
78392|NCT02540889|"~     The main aim is to develop and test the clinical efficacy of a novel, web based,~     rehabilitation application. Listen-In will provide an effective speech comprehension training~     tool that patients with aphasia can use to practice independently. This will free up~     therapists time to provide additional assessment, supervision and functional intervention in~     a highly cost effective manner.~   "
78393|NCT02540876|"~     This pilot phase I trial studies how well ilorasertib works in treating patients with~     cyclin-dependent kinase inhibitor 2A (CDKN2A)-deficient solid cancers that have spread to~     other places in the body and usually cannot be cured or controlled with treatment (advanced)~     or have spread to other places in the body (metastatic) and cannot be removed by surgery.~     Ilorasertib may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth.~   "
78394|NCT02540863|"~     Objectives: The aim of this research is to compare the effectiveness of myofascial release~     therapy and exercise therapy on pain, quality of sleep, anxiety, trigger points, and joint~     sounds in individuals with temporomandibular disorders and myofascial pain-dysfunction~     syndrome.~      Material and Methods: A single-blind randomized clinical trial will be conducted in a~     university research clinic. Sixty-four subjects with temporomandibular disorders and~     myofascial pain-dysfunction syndrome will be randomly assigned to physical therapy group~     (myofascial release protocol and Rocabado exercise therapy) and control group (exercise~     therapy). Intensity of pain, quality of life, quality of sleep, anxiety, trigger points, and~     joint sounds will be collected at baseline, and forty-eight hours after the intervention~     phase.~   "
78395|NCT02540850|"~     The purpose of this study is to evaluate the performance of the SEPT9 gene methylation assay~     in Colorectal cancer (CRC) high-risk population in Chinese hospitals using the opportunistic~     screening method. The trial plans to evaluate a Chinese domestic SEPT9 assay kit produced by~     BioChain (Beijing) Science and Technology Corporation, who is a close partner of Epigenomics~     AG, the producer for Epi proColon 2.0 CE.~   "
78396|NCT02540837|"~     A higher number than expected of patients with hip fracture have only insufficient analgesic~     effect of a femoral nerve block, which is the nerve block commonly used for this group of~     patients. One of the possible causes of this failure to provide analgesia from a single nerve~     block could be the that other nerves are involved in transmitting the pain signal. One of the~     nerves that is believed to give off branches to the hip is the obturator nerve.~      With ultrasound it is possible to make a selective proximal nerve block of the obturator~     nerve.~      The aim of this trial is to test the analgesic effect of a femoral nerve block i combination~     with an obturator nerve block compared to femoral nerve block alone in a randomized and~     placebo controlled design.~   "
78397|NCT02540824|"~     RET fusions are present in 1% to 2% of unselected population of non-small cell lung cancer~     (NSCLC). Existing US Food and Drug Administration-approved inhibitors of RET tyrosine kinase~     show promising therapeutic effects in a non-small cell lung cancer patients. Apatinib is an~     oral multi-kinase inhibitors including RET fusions. This study is designed to evaluate the~     safety and tolerability of Apatinib in patients with RET fusion positive advanced NSCLC.~   "
78398|NCT02540811|"~     The safety and performance of dCELL® ACL Scaffold will be evaluated in 40 patients who have~     been implanted with the investigational product following a ruptured anterior cruciate~     ligament (ACL) of the knee.~   "
78399|NCT02540798|"~     This study will look at how pre-test anxiety levels affect the reproducibility of symptoms~     during routine urodynamic testing in women. Urodynamics is a test that assesses the function~     of the lower urinary tract, including the bladder.~   "
78400|NCT02540785|"~     The aim is to evaluate the short-term changes in ocular surface measures and tear~     inflammatory mediators after lenticule extraction (FLEx) and small-incision lenticule~     extraction (SMILE) procedures.~   "
78401|NCT02540772|"~     Confabulators consistently generate false memories without intention to deceive and with~     great feeling of rightness. However, there is currently no known effective treatment for~     them. In order to fill this gap, the aim of this trial was to design a neuropsychological~     treatment based on the current theoretical models and test it experimentally in two groups of~     confabulators: experimental vs. control. The treatment consisted of some brief material that~     patients had to learn and recall at both immediate and delayed moments. After both~     recollections, patients were given feedback about their performance (errors and correct~     responses). Pre-treatment and post-treatment baselines were administered. Confabulators in~     the control group performed the baselines without treatment, and were then offered the~     treatment after the second baseline.~   "
78402|NCT02540759|"~     The effect of various doses of Buglossoides oil on the accrual of eicosapentaenoic acid (EPA)~     in blood and circulating cells will be investigated.~   "
78403|NCT02540746|"~     The aim of this pilot study is to examine a brief manualized treatment, Emotional Regulation~     Group Skills Training (ERG ST), which has shown promise with high-risk youth presenting with~     a range of mental health concerns. The investigators will examine the effectiveness of a ERG~     ST group, as well as two additional components to which clients will be randomized: a~     motivational enhancement (ME) pre-treatment, and family skills treatment (FAM). This project~     will be the first to combine and test these modules as a transdiagnostic early intervention~     for youth in the early stages on mental illness. This pilot trial will answer the following~     questions: 1) What is the response rate to ERG ST compared to ERG ST plus FAM, and who~     benefits? 2) What is the response rate to a ME pre-treatment, and who benefits? 3) What is~     the acceptability of this treatment?~      The ME pre-treatment will consist of four weekly one and a half hour sessions. The 12-week~     ERG ST will consist of 12 weekly two-hour sessions with 4-12 youths per group. The 12-week~     FAM will consist of 12 weekly two-hour sessions, with 16-20 caregivers per group. This study~     will use a two-stage randomization design to allow for balanced groups if there is~     differential attrition after pre-treatment. The following are the four treatment~     combinations: ERG ST; ERG ST+FAM; ME+ERG ST; ME+ERG ST+FAM. Four subjects will be enrolled in~     the study and randomized. The primary outcome is to improve emotion dysregulation in~     participants. Emotion dysregulation will be measured using the Difficulties in Emotion~     Regulation Scales (DERS).~   "
78404|NCT02540733|"~     Diabetes mellitus (DM) plays an important role in the occurrence of the cerebral infarction~     (CI). Clinical studies have demonstrated that the CI patients with DM had a poor prognosis~     compared with those without DM. Previous magnetic resonance imaging (MRI) studies have shown~     that patients with DM had abnormalities in cerebral vessels, nerves and functions, similar~     with the findings in mice models. In this study, with multi-modal MRI technologies,~     investigators tend to observe structural and functional changes of the brain in both DM and~     non-DM CI patients and assess their neural rehabilitation using clinical scales in the~     following 6 months. Investigators also expect to find out dynamic changes of brain structure~     and function, to reveal the weights of factors including brain blood vessels, nerves and~     function remodeling related with stroke recovery, as well as the potential mechanism in CI~     patients with DM.~   "
78405|NCT02540720|"~     This study is performed to evaluate the efficacy and safety of various measures in the~     treatment of severe HSP in children.~   "
78496|NCT02539485|"~     The effect of heating precondition of streamlined liner of the pharynx airway (SLIPA) on~     respiratory mechanics and sore throat was investigated.~   "
78406|NCT02540707|"~     Background/Purpose: The overactive bladder syndrome (OAB) affects around 17 % of female~     population. Antimuscarinics can affect autonomic system, arterial stiffness and psychosomatic~     distress. However, there is no such research for the new drug- mirabegron (a β3-agonist).~     Thus, the aim of our study is to analyze the between-group differences in heart rate~     variability, cardio-ankle vascular index, ankle-brachial pressure index, psychosomatic~     distress, personality trait, family support and clinical outcomes between the mirabegron and~     the solifenacin groups.~      Patients and Methods: The investigators will perform a prospective randomized controlled~     study to recruit 150 female OAB patients at the outpatient clinic of Department of Obstetrics~     and Gynecology of National Taiwan University Hospital. All OAB female patients will be asked~     to complete Urgency Severity Scales, Overactive Bladder Symptoms Scores questionnaires,~     King's Health questionnaires, UDI-6 & IIQ-7, Patient Health Questionnaire, brief symptom~     rating scale (BSRS), Maudsley personality inventory (MPI) and adaptability, partnership,~     growth, affection, and resolve (APGAR) questionnaires, Sleep and Dietary habit Questionnaire,~     standard 12-leads electrocardiography (ECG), 5 minutes Holter monitoring, cardio-ankle~     vascular index (CAVI) test, bladder diary, 20-min pad test, urodynamic studies and~     measurement of urinary nerve growth factors level before and after 12 weeks' mirabegron~     versus solifenacin treatment. STATA software is used for statistical analyses.~      Possible Results: The investigators can answer that the between-group differences in heart~     rate variability, cardio-ankle vascular index, ankle-brachial pressure index, psychosomatic~     distress, personality trait, family support and clinical outcomes between the mirabegron and~     the solifenacin groups. The above conclusions should be important for pre-treatment~     consultation.~   "
78407|NCT02540694|"~     Rationale:~      Endosonography with mediastinal/ hilar nodal sampling is the test of choice to diagnose~     sarcoidosis stage I and II - in case tissue verification of noncaseating granulomas is~     indicated. However, the optimal endosonographic approach (endobronchial or transoesophageal)~     for mediastinal nodal sampling is under discussion.~      Secondly, which needle size or type provides optimal tissue sample quality for granuloma~     detection is unknown. The novel 25 Gauge (G) beveled ProCore needle, allows tissue~     acquisition of small core biopsies in addition to cytological aspirates.~      Hypotheses:~        1. Esophageal ultrasound guided (EUS-B) sampling of intrathoracic lymph nodes has a 14%~          higher granuloma detection rate compared to endobronchial ultrasound (EBUS) guided nodal~          sampling in patients with suspected sarcoidosis stage I/II.~        2. 25G ProCore needles provide superior sample quality compared to conventional 22G needles~          in patients with suspected sarcoidosis stage I/II.~      Study design:~      Investigator initiated, randomized clinical trial. Setting: International, multicenter~     (university and general hospitals)~      Study population:~      Consecutive patients with a clinical and radiologic suspicion of sarcoidosis stage I or II~     and an indication for tissue verification of non-caseating granulomas are eligible for~     inclusion.~      Intervention:~      EBUS vs EUS-B, simultaneously comparing the standard vs novel ProCore needles.~      Main study endpoints:~        1. The granuloma detection rate of endobronchial (EBUS) guided sampling of intrathoracic~          lymph nodes compared to esophageal (EUS-B using the EBUS scope) guided sampling in~          patients with suspected sarcoidosis stage I/II.~        2. Sample quality of conventional 22G vs. 25G ProCore needles in patients with suspected~          sarcoidosis stage I/II.~   "
78408|NCT02540681|"~     The aims of this study address an exploratory endpoint in the Major Extremity Trauma Research~     Consortium (METRC) Transtibial Amputation Outcomes Study (TAOS; NCT01821976) that is~     investigating prosthesis fit, alignment and condition of the residual limb. As there are no~     validated measures of fit and alignment (factors known to impact comfort, function and~     performance among amputees) the TAOS study includes a provision in the protocol for~     acquisition of photographs, video and radiographs in order to help develop uniform~     assessments of the residual limb. The goal of the ProFit study is to validate and refine the~     prosthetic assessment tool (ProFit) that was developed by an expert panel of certified~     orthotist prosthetistis (CPOs) in collaboration with orthopaedic trauma investigators, a~     measurement scientist and a biomedical engineer from the BADER consortium.~   "
78409|NCT02540668|"~     The purpose of this study is to look at how much warfarin gets into the blood stream and how~     long it takes the body to get rid of it when given both with and without lanabecestat.~     Another purpose is to evaluate the effectiveness of warfarin therapy to prevent blood clots~     when given with lanabecestat by measuring international normalized ratio (INR). INR measures~     the time it takes for blood to clot and compares it to an average. Information about any side~     effects that may occur will also be collected. The study will last about 5 weeks from the~     first dose to follow-up for each participant.~   "
78410|NCT02540655|"~     The purpose of the clinical trial is to study the therapeutic efficacy and safety of~     Stemchymal® infusions for polyglutamine spinocerebellar ataxia treatment by a randomized,~     double-blind, placebo-controlled study design. Eligible subjects will receive Stemchymal®~     through intravenous infusion.~   "
78411|NCT02540642|"~     Increased plasma homocysteine level is associated with macroangiopathy and nephropathy in~     type 2 diabetes. Also increased levels of serum homocysteine are associated with~     microalbuminuria which is associated with increased cardiovascular morbidity and mortality~     among the patients with type 2 diabetes. With B12 supplementation homocysteine level can be~     reduced .Type 2 diabetes as a metabolic syndrome may show improvement in glycaemic control~     with Vitamin B12 therapy as there is correction of hyperhomocysteinemia. In studies it is~     proved that combination of vit B12, folic acid and vit B6 are effective for~     hyperhomocysteinemia.There are no such separate trials on the use of vit B12 alone. This~     therapy may be used in large number of type 2 uncontrolled diabetic hyperhomocysteinemic~     patients.~      this study was planned with following objectives to study effect of Vitamin B12~     supplementation on glycaemic control in poorly controlled hyperhomocysteinemic type 2~     diabetic patients~        1. Glycaemic control measured by levels of glycosylated haemoglobin (HbA1c) at baseline and~          4 weeks~        2. Fasting blood sugar level at baseline and 4 weeks~        3. Serum homocysteine/ vitamin B12 levels at baseline and 4 weeks~        4. Serum lipid profile at baseline and 4 weeks~   "
78412|NCT02540629|"~     This study aims to improve the survival rate of out-of-hospital cardiac arrest patients by 2%~     through a bundle of three intervention measures including: 1) dispatcher-assisted CPR, 2)~     multi-tiered response team CPR, and 3) feedback CPR.~   "
78413|NCT02540616|"~     The goal of this study is to determine whether external neuromodulation using transcranial~     electrical stimulation (TES) can reduce the perception of self-motion that is experienced by~     patients with MdDS. Mal de debarquement is translated as the sickness of disembarkment, and~     refers to the chronic feeling of rocking dizziness that occurs after exposure to passive~     motion. A similar form of rocking dizziness can be experienced without a motion trigger in~     individuals with certain risk factors.~      Treatment for MdDS is limited and morbidity is high.The goal of the study is to determine~     whether TES can suppress the rocking dizziness of MdDS either as a standalone therapy or as~     an adjunctive therapy to other forms of neuromodulation such as transcranial magnetic~     stimulation. The investigators will determine the optimal treatment duration and stimulation~     parameters.~   "
78414|NCT02540603|"~     This investigation is designed to evaluate the performance (leak and comfort) as well as~     participant's overall acceptance of the investigative full face mask amongst OSA~     participants.~   "
78652|NCT02537418|"~     The purpose of this study is to find the highest dose of durvalumab or of durvalumab with~     tremelimumab that can be tolerated without causing very severe side effects when receiving~     standard chemotherapy and to see what effects the study drugs has on this type of cancer.~     Patients may receive durvalumab alone or in combination with tremelimumab.~   "
78415|NCT02540590|"~     Our overall goal is to characterize the role of the microcirculation in healing oral mucosa~     after routinely applied surgery intervention in order to facilitate treatment. Using Laser~     Speckle Contrast Analysis (LASCA), which provides blood perfusion data, the investigators~     will have the possibility to detect functional alterations in gingival microcirculation in~     case of wound healing. After periodontal surgery, by means of the detection of~     microcirculation as a prognostic and diagnostic factor, the investigators can follow-up the~     healing procedure and obtain data so as to design e.g. the incision line that takes~     microvascular anatomy into account, thus result in better wound healing later on.~   "
78416|NCT02540551|"~     Recently the investigators have shown that the SN procedure performed through the injection~     of tracers into the ovarian ligaments is feasible and promising in patients with clinical~     early stage ovarian cancer (OC). Injection of radioactive tracers resulted in the~     identification of SNs in all 21 patients. Before a multicentre prospective trial can be~     initiated, still some questions have to be answered, especially if a SN procedure still is~     feasable in patients with OC through injection of the tracers in the ovarian ligaments, when~     the ovarian tumour has already been resected, either during the same surgical procedure~     (ovarian tumour resected for frozen section with a malignancy as result) or at a second~     surgical procedure to complete the staging procedure (by laparotomy or laparoscopy).~   "
78417|NCT02540538|"~     The purpose of this study is to determine whether the HBAI20 vaccine is safe and more~     immunogenic than the HBVaxPro-10µg in people who have never been vaccinated with a hepatitis~     B vaccine and in people who have been vaccinated 6 times with hepatitis B vaccine but do not~     have a protective anti hepatitis B antibody titer.~   "
78418|NCT02540525|"~     1. OBJECTIVE:~           To determine the efficacy and safety of a single-incision mini-sling compared with a~          transobturator midurethral sling for stress urinary incontinence (SUI) treatment.~        2. METHODS:~      This prospective single-center randomized controlled trial will involve 100 women with a~     diagnosis of SUI. Primary outcomes were the objective and subjective cure rates, defined as~     negative cough stress and pad tests, and satisfaction rates. Quality of life assessed by the~     Incontinence Quality of Life Questionnaire and the Urogenital Distress Inventory Short Form,~     operation time, complications, and reoperation rates were also recorded. The efficacy was~     analyzed using a noninferiority test with a margin of 15%. For the noninferiority test, a P~     value >.05 rejects the noninferiority hypothesis of the mini-sling.~   "
78419|NCT02540512|"~     The purpose of the study is to test auricular (ear) acupuncture for the acute management of~     patient pain in the Emergency Department as an alternative and adjunct to standard medical~     treatment.~      Currently, physicians who practice medicine here in the United States only have~     pharmacological intervention at their disposal as the only available treatment tool they have~     for the treatment and management of pain, and as a result, painkiller misuse, overdose, and~     death has become the leading health epidemic in America. American healthcare is in desperate~     need of alternative and safer ways to prevent prescription painkiller overdoses and to better~     manage pain. If prescription painkiller dependencies can be avoided at the source,~     potentially many lives and healthcare dollars can be saved. Acupuncture is an alternative~     treatment that has been effectively used to treat pain for thousands of years in countries~     around the world. The National Institutes of Health (NIH) and the United Nations World Health~     Organization (WHO) have stated that acupuncture is a safe and effective treatment for the~     management of pain. Supported by many studies illustrating seventy-five to ninety-nine~     percent effectiveness in treating pain with an instantaneous drop in pain by twenty-five to~     eighty percent, acupuncture appears to be the safest and most effective option available to~     manage pain syndromes in the emergency department.~      Auricular acupuncture has demonstrated beneficial effects to reduce acute and chronic pain~     intensity. Specifically, for the thesis of this clinical trial, the investigators hypothesize~     that auricular acupuncture can be an effective alternative and/or adjunct treatment tool in~     the civilian emergency department for the acute management of pain.~      In order to test the safety and efficacy of using auricular acupuncture in the emergency~     department, people presenting to the emergency department with pain who are willing to~     participate in the study will be randomized into three separate groups:~        1. Standard medical group (tape on ear + standard medical drug)~        2. Standard medical group plus auricular acupuncture (acupuncture + standard medical drug)~        3. Auricular acupuncture group (acupuncture + placebo pill)~      The design of these groups will allow the investigators to best test the efficacy of~     auricular acupuncture versus the placebo effect and standard medical care as well as an~     adjunct to standard medical care. To accomplish the objective of this proposal, the~     investigators will pursue the following specific aims:~      Specific Aim 1: To prove the efficacy of auricular acupuncture over a placebo group in the~     management of pain syndromes. By having the acupuncture group and sham acupuncture group, the~     investigators will be able to effectively compare the difference in pain levels with a~     placebo-group.~      Specific Aim 2: To prove that auricular acupuncture is an effective alternative and/or~     adjunct to standard medical care in the Emergency Department.~      By testing the efficacy of acupuncture in conjunction with standard medical treatment, the~     investigators expect to see a potentiation of analgesic effects, and this will be noted by an~     increased reduction in pain between the standard medical plus acupuncture group versus the~     standard group and acupuncture group.~      Specific Aim 3: To prove that auricular acupuncture as an effective pain management~     alternative that decreases short-term prescription painkiller dependency.~      Through a series of follow up questionnaires and a medication diary that the investigators~     will give to the patient prior to discharge, the investigators will track the patient's need~     and use of additional pain medications post treatment. These surveys will give a good~     indication as to the effectiveness of auricular acupuncture to reduce a patient's dependency~     on painkiller drugs in the short-term setting.~   "
78420|NCT02540499|"~     Despite considerable advances in cancer treatment, patients with locally advanced lung cancer~     still face a poor chance of survival and a high risk of experiencing serious, life~     threatening treatment-related side-effects. These side-effects are poorly understood and~     difficult to measure: it is therefore challenging to design new treatment strategies aiming~     to decrease treatment toxicity and yet increase survival. At present, many patients present~     with tumours so large that only a low palliative dose of radiation therapy can be offered in~     order to keep the risk of side-effects to an acceptable level. In this project, named INHALE,~     the possibility of irradiating lung cancer patients while they hold their breath in deep~     inspiration (so called: Deep inspiration breath hold, or DIBH) will be investigated. In DIBH,~     the healthy lung tissue is pushed away from the tumour, and even when a large tumour is~     present, a high curative dose of radiation therapy can be offered. This technique is simple~     and is widely used to treat breast cancer patients in our institution as well as in other~     centres in the world. If positive, results from INHALE can be transferred easily and with~     minimal costs throughout Denmark and the rest of the world.~      DIBH has only sporadically been used in lung cancer patients to date, because of the~     assumption that this patient group, often having a poor performance status, could not comply~     with DIBH procedure. However, the investigators' experience has shown that the majority of~     lung cancer patients can comfortably hold short repeated DIBHs during treatment sessions~     throughout the eight weeks of their treatment course, even if they have a relatively poor~     lung function.~      The differences in side-effects between patients treated with the INHALE regimen and a large~     group of patients previously treated at our institution will be thoroughly investigated,~     using both follow-up CT images and a range of clinical parameters. INHALE is a unique study~     because of combining use of the highest level of technology to ensure high-quality treatment~     in DIBH and a thorough scientific investigation of follow-up data. INHALE will provide an~     improved understanding of how to assess and decrease treatment side-effects: consequently the~     investigators aim to test the hypothesis in a large clinical trial in order to improve~     survival of lung cancer patients.~   "
78421|NCT02540486|"~     Evaluating patients with type 2 diabetes either starting once daily basal insulin or~     requiring increased basal titrations in order to compare the LTHome web based tool with the~     usual standard of practice for insulin glargine dosing adjustment.~   "
78422|NCT02540473|"~     Physicians in general are at risk for burnout, and this risk is heightened among women,~     particularly mothers. In a randomized design, central hypotheses in this study are that~     mothers who attend our 12-week Relational Psychotherapy Mothers Group (RPMG) intervention~     will show significantly greater decreases in stress, depression, burnout, and associated risk~     biomarker indices, as compared to comparison controls (who would meet in unstructured~     gatherings, for an hour a week for 12 weeks). Additionally the investigators hypothesize that~     the gains would be maintained three months after the intervention is completed.~   "
78423|NCT02540460|"~     The purpose of this study is to investigate the population pharmacokinetics of LCB01-0371~     after a multiple oral dose in healthy male subjects.~      To investigate safety, tolerability of LCB01-0371 after a multiple oral dose in healthy male~     subjects.~   "
78424|NCT02540447|"~     The investigators tested the impact of purging the graft contents and mesenteric blood into~     the systemic circulation versus washing out this volume out of the circulation in living~     donor liver transplantation recipients.~   "
78425|NCT02540434|"~     The study aligns with the strategic plan of New York-Presbyterian Hospital (NYPH) to reduce~     allogeneic blood product use and decrease unnecessary laboratory costs. One of the NYPH~     Quality and Patient Safety Goals for 2013 was to improve the appropriate use of transfusion~     guidelines and reduce unnecessary red blood cell (RBC) transfusions. Further, this study will~     help to answer whether RiaSTAP is a more effective product to treat bleeding than~     cryoprecipitate. In addition, this trial will provide investigators with preliminary data to~     apply for future federal funding opportunities, such as the National Heart Lung and Blood~     Institute sponsored R21 grant (PAR-13-025) that encourages research grant applications from~     investigators who propose to study research topics in blood banking and transfusion medicine~     aimed at improving the safety and availability of the blood supply and the practice of~     transfusion medicine. The investigators anticipate future follow-on studies further~     investigating fibrinogen concentrate and other similar therapeutics in other perioperative~     populations, such as in postpartum hemorrhage or surgical ICU settings. Finally, this study~     involves the use of a safer therapeutic, fibrinogen concentrate, to improve patient care and~     patient safety. This product does not require the time-intensive process of thawing;~     therefore, delays in patient care can be avoided by having the product readily available in~     the OR.~   "
78426|NCT02540421|"~     Objectives: To identify factors associated with disease recurrence in patients with~     high-grade cervical intra-epithelial neoplasia (CIN) undergoing large loop excision of the~     transformation zone (LLETZ).~      Study Design: A case-control study that included 103 patients. Patients were included in the~     study if they had a history of surgery for conization by LLETZ for the histopathological~     diagnosis of cervical intraepithelial neoplasia grades II and III (CIN II and CIN III).~     Follow-up exams were conducted every six months with Pap smear collection and colposcopic~     examination with biopsy, when necessary, for a minimum period of twelve months. Cure was~     defined as a normal follow-up examination within 24 months. During follow-up, relapse~     occurred when cytology and/or biopsy results showed that CIN had returned after 12 months, at~     which time a new cervical conization by LLETZ was performed.~   "
78427|NCT02540408|"~     A pilot study from the investigators group suggests that the prevalence of chronic~     obstructive pulmonary disease (COPD) among dairy farmers is higher than in the general~     population. Most characteristics of COPD in dairy farmers (smoking habits, dyspnoea, quality~     of life, lung function, bronchial exhaled nitric oxide, systemic inflammation, arterial~     stiffness and exercise capacity) are largely unknown. Although immunization against organic~     dusts is suspected, the pathophysiology of COPD in dairy farmers is also unknown.~      This study therefore aims at (i) comparing the prevalence of COPD in dairy farmers and in~     subjects without any occupational exposure (control arm) through a vast COPD detection~     program in the Franche-Comté region; (ii) comparing several characteristics (smoking habits,~     dyspnoea, quality of life, lung function, bronchial exhaled nitric oxide, systemic~     inflammation, arterial stiffness and exercise capacity) between dairy farmers with COPD and~     patients with COPD without any occupational exposure; (iv) identifying etiological factors of~     COPD in dairy farmers (comparison of exposure and specific immunoglobulin E between dairy~     farmers with COPD and dairy farmers with normal pulmonary function tests); and (v)~     constituting a cohort of COPD patients and control subjects for further longitudinal studies.~      Data from selected patients (either current or former smokers) with mild COPD and from~     matched controls will also be analyzed in an ancillary study which objectives are to compare~     exercise tolerance, ventilatory constraints on tidal volume expansion and dyspnoea between~     asymptomatic mild COPD subjects, symptomatic mild COPD and healthy controls.~   "
78428|NCT02540395|"~     The main objective of the study is to demonstrate the utility and safety of the IFN-γ~     (Interferon Gamma) ELISPOT (Enzyme-linked immunosorbent spot) marker for the stratification~     of kidney transplant recipients into low and high IS (Immunosuppression) regimens. The~     enrichment study will test non-inferiority of low IS regimen compared to high IS regimen,~     assuming 10% of BPAR at 6-months in the control group, and allowing a non-inferiority limit~     of maximum 10%.~   "
78429|NCT02540382|"~     Investigators aim to compare the efficacy of 8 mm Fluency covered stent and bare stent in~     transjugular intrahepatic portosystemic shunt (TIPS) for the treatment of cirrhotic portal~     hypertension.~   "
78430|NCT02540369|"~     To describe the use of intravitreal aflibercept in routine clinical practice and to describe~     follow-up as well as treatment patterns in patients with wAMD or DME in routine clinical~     practice in Canada for a study population of treatment naive patients and those who have~     received prior therapy (anti-VEGF injections, laser, steroids, etc).~   "
78431|NCT02540356|"~     The purpose of this study is to evaluate the safety and tolerability of BAX69 monotherapy~     given either as intraperitoneal (IP) infusion (Single-Route Arm); or as IP infusion after~     intravenous (IV) infusion (IV+IP) (Double-Route Arm), and to determine the maximum tolerated~     dose (MTD) and recommended Phase 2 dose (RP2D) for each Arm separately, in subjects with~     refractory ovarian cancer and recurrent malignant ascites. In both Arms, the plasma~     pharmacokinetics (PK) of BAX69 will be characterized, and pharmacodynamics (PD) markers will~     be explored in plasma and ascites. Two expansion cohorts will further assess the tolerability~     of the RP2D and explore clinical signs of efficacy.~   "
78432|NCT02540343|"~     The aim of this study is to adapt and translate the Orebro Musculoskeletal Pain Questionnaire~     into German.~   "
78433|NCT02540330|"~     This is an open-label, non-randomized pharmacokinetic study of fulvestrant in women scheduled~     for mastectomy or lumpectomy. Eligible subjects will be identified with breast cancer or~     DCIS. The first subject of each of five groups will receive fulvestrant intramuscularly. The~     subsequent 5 subjects of each group will receive fulvestrant by intraductal instillation. All~     subjects will be monitored for systemic and local adverse events during the procedure, and~     following the procedure until mastectomy or lumpectomy. Subjects that receive fulvestrant~     will undergo serial blood draws to determine fulvestrant blood concentration levels.~   "
78434|NCT02540317|"~     Stress disorders in form of adjustment disorder and burnout syndrom are highly prevalent and~     cause substantial suffering. Prior evidence suggest that these disorders may be effectively~     treated with cognitive behavior therapy (CBT), but access to psychological treatment is~     limited. One possible solution is to provide therapy via the Internet, which has been shown~     to be effective for anxiety disorders and depression. In the present study, we will~     investigate the efficacy of Internet-based CBT (ICBT) for adjustment disorders and burnout~     syndrom in a randomized controlled trial (N=100). Participants will be randomized to active~     treatment (n=50) or a control condition on waiting list.~   "
78435|NCT02540304|"~     This study is evaluating the effectiveness of three evidence-based teen pregnancy prevention~     (TPP) programs in reducing sexual risk-taking behaviors of youth. The study is using an~     experimental design in which youth are randomly assigned to receive either TPP programming or~     services as usual.~   "
78436|NCT02540291|"~     This is an open label, multicenter, Phase 1 study of E7046 to assess the safety and~     tolerability of E7046 and to determine the maximum tolerated dose (MTD) and/or the~     recommended Phase 2 dose (RP2D) of E7046.~   "
78437|NCT02540278|"~     This study aims to determine if the Positive Prevention PLUS teen pregnancy prevention~     program has an impact on abstinence, birth control use, and likelihood of becoming pregnant.~   "
78438|NCT02540265|"~     The primary objective of this study is to evaluate the safety of N1539 in subjects with acute~     moderate to severe pain following unilateral bunionectomy.~   "
78653|NCT02537405|"~     The objectives of this study are to establish the bioequivalence between rivaroxaban tablet~     10mg and rivaroxaban granule formulation 10mg, and to assess the safety and tolerability of~     rivaroxaban 10mg in healthy adult male subjects.~   "
78439|NCT02540252|"~     Patients with non-traumatic lower limb amputation are characterized by; high age; majority~     being men; multimorbidity; and high mortality. The patients comorbidities are related to~     diabetes and cardiovascular disorders such as arteriosclerosis.~      Major surgery induces a surgical stress response that initiates a catabolic metabolism.~     Furthermore, the risk of systemic inflammatory response syndrome (SIRS) both before and after~     amputation is high (3) as the most prominent indication for amputation is gangrene, followed~     by non-healing or infected wounds. This leads to an impaired immune response and an increased~     insulin resistance that also includes a cascade of impaired appetite regulation, low dietary~     intake and reduced nutrient uptake form the intestine which increases inflammation, loss of~     muscle and risk of severe complications.~      Among healthy adults with a normal weight a slow speed of eating will result in a low~     nutritional intake due to faster satiety experience.~      Low appetite following major surgery is related to the regulation of hormone controlling the~     appetite. Especially older patients experience variations in appetite that affect their~     eating pattern such as eating speed and intake. It is therefore reasonable to assume that the~     speed of eating and the total nutritional intake among older patients, who are exposed to~     catabolic metabolism, are associated.~      The hypothesis is that major surgery induces a change in patients' current eating pattern~     that is measurable and can be identified as a surrogate measurement of the catabolic state~     that is related to inflammation.~      Eating Patterns are often described in clinical practice without engaging in nutritional~     assessment of the patient. Whether the speed of eating is an objective marker of the current~     nutritional status has not been established.~      This study investigates patients undergoing lower limb amputation and their nutritional~     status, eating pattern and inflammation and whether this is linked to the current degree of~     disease. The purpose is to describe the development in nutritional status before and after~     amputation and to investigate associations between patients eating pattern and nutritional~     status to inflammatory and metabolic biomarkers reflecting the degree of disease.~   "
78440|NCT02540239|"~     To evaluate the efficacy, visibility of low volume polyethyleneglycol-simeticone (2-LPEG-S)~     for colonoscopy.~   "
78441|NCT02540226|"~     Tranexamic acid (TXA) is a drug that is being used more frequently at the Hospital for~     Special Surgery to lessen the amount of blood loss after total knee replacement (TKR). It is~     an anti-fibrinolytic agent, which means that it promotes the formation of blood clots. TXA~     can be given either intravenously or topically (placed directly on the open wound) before~     wound closure. Patients with certain medical conditions have been found to have a high risk~     of thrombosis after being given intravenous TXA, which may lead to serious complications.~     However, to date, no high-risk patients have been identified for use of topical TXA. This~     study will look at thrombogenic markers (proteins found in blood that promote clot formation)~     after TXA is given either intravenously or topically. If the effect on these markers is~     similar between intravenous and topical use of TXA, then the safety of topical TXA should be~     questioned. Of note, these markers have never been measured after TXA has been given~     topically. As a result, this information would be important for the medical community.~   "
78442|NCT02540213|"~     This non-interventional, observational study investigates the efficiency, safety and~     acceptance of MIRCERA in participants, who received erythropoiesis stimulating agent (ESA)~     using a self-application system. For each participant, the investigator documents 9 months of~     treatment with Mircera with respect to efficacy, safety and acceptance.~   "
78443|NCT02540200|"~     Hip pain in young patients is difficult to diagnose and treat. However, with advanced imaging~     techniques and surgical method, the investigators are able to identify hip cartilage lesions~     as a cause for the hip pain. MR (magnetic resonance) arthrography is the best imaging~     modality to diagnose chondral lesions of the hip, but it occasionally miss the pathology,~     thus necessitating a more accurate and invasive means of diagnosis. Consequently, hip~     arthroscopy is increasingly used for both diagnosis and treatment for hip cartilage~     pathology.~      Microfracture is a means of stimulating bone marrow, and is a standard treatment for small~     chondral lesions. This procedure has shown to result in excellent functional and anatomical~     outcomes. Microfracture is now recognized as a standard treatment for cartilage lesions in~     the knee, and recently the indications of this technique extended to hip pathology.~      The BST-CarGel device (Piramal Life Sciences, Bio-Orthopaedic Division) is based on the~     patented technology for cartilage repair. BST-Gel comprised of the buffer~     beta-glycerophosphate and chitosan, which is a well-studied natural material that is~     biocompatible and appropriate for its use as a scaffold to assist in cartilage repair.~     BST-Gel is mixed with the patient's whole blood and delivered to a surgically prepared~     cartilage lesion in conjunction with bone marrow stimulation. The BST-CarGel/blood mixture~     solidifies in the cartilage lesion and provides a three-dimensional scaffold for the repair~     process. This product has shown to result in superior chondral lesion repair when compared to~     the bone marrow stimulation alone.~      The current study will collect data through standard of care practice when BST-CarGel in~     conjunction with a bone marrow stimulation technique is used for the treatment of focal~     cartilage lesions in the hip. In addition, these patients in the study group will be compared~     with the group o patients who undergo the bone marrow stimulation technique alone. The~     efficacy of BST-CarGel in conjunction with microfracture for cartilage lesions in the knee~     has been shown in previous studies. Additional research is required to expand knowledge and~     develop treatment guidelines for the treatment of the cartilage lesions in the hip using~     BST-CarGel. As the BST-CarGel improves the results of the bone marrow stimulation techniques~     without increasing the risks of the procedure, this device can be very beneficial in the case~     of cartilage lesions in the hip.~   "
78444|NCT02540187|"~     Haemophilia is a rare and serious congenital defect of blood coagulation due to a genetic~     mutation on a sexual chromosome. It affects quasi-essentially the men and it is responsible~     for bleeding. There are two types of haemophilia: Haemophilia A, (85 % of cases), due to a~     factor VIII (FVIII) deficiency and Haemophilia B (15 % of cases) due to factor IX (FIX)~     deficiency. According to the intensity of the defect, there are three forms of haemophilia:~     severe (FVIII or FIX lower than 1 %), moderate (factor level between 1 and 5 %), minor~     (factor level between 5 and 40 %). For a same level of factor VIII or IX, hemorrhagic~     manifestations are variable from one patient to the other. Moreover, several studies showed~     that haemophilic B patients bleed less and consume fewer anti-hemophilic concentrate that~     haemophilic A patients.~      The main inhibitors of the coagulation are antithrombin, Protein C-Protein S-Thrombomodulin~     system, and tissue factor pathway inhibitor (TFPI). TFPI is the specific and exclusive~     inhibitor of tissue factor pathway that is the main way by which plasmatic coagulation~     starts. TFPI is a potent direct inhibitor of factor Xa and Xa-dependent inhibitor of the~     VIIa-Tissue Factor (TF) complex. In hemophilic patient, the production of Xa by the~     amplification pathway being strongly altered because of factor VIII or IX deficiency,~     thrombin generation (via Xa) comes exclusively from TFPI regulated tissue factor pathway. We~     can thus say that if haemophilic patients bleed, it is also because of the presence of TFPI~     that inhibits at the same time Xa and the complex TF-VIIa as soon as factor Xa is generated.~   "
78445|NCT02540174|"~     This is a multicenter, interventional, randomized study among patients with a first lung or~     head & neck cancer who are still active smokers ± alcohol misusers.The study will aim to~     compare the systematic implementation of an addiction treatment program initiated at hospital~     and integrated to the initial cancer treatment program (Arm A), versus the as-usual~     procedure, which consists in recommendations to follow an addiction treatment program (Arm B)~   "
78446|NCT02540161|"~     The purpose of this study is to assess the activity of Sym004, a recombinant antibody mixture~     that specifically binds to EGFR, in patients diagnosed with recurrent glioblastoma whose~     tumor is EGFR amplified. This is a phase 2 study that will accrue patients with WHO grade IV~     recurrent malignant glioma (glioblastoma or gliosarcoma) in two cohorts to assess the~     efficacy of Sym004.~   "
78447|NCT02540148|"~     This randomized study will assess the effectiveness of externally applied micro current~     electrical stimulation on improving the visual acuity in subjects with vision loss from dry~     (non-neovascular) age-related macular degeneration (AMD) over a 6 week period.~   "
78448|NCT02540135|"~     This study plans to learn more about if fluorescein with intraoperative Magnetic Resonance~     Imaging (MRI) is as good as intraoperative MRI (iMRI) alone in detecting the presence of~     tumor tissue during surgery.~      Both fluorescein and intraoperative MRI have been studied and routinely used to aid the~     neurosurgeon in distinguishing normal brain from tumor, helping the neurosurgeon to safely~     resect more tumor tissue during surgery.~      This study will enroll patients with malignant high grade glioma who are going to have a~     surgery to remove their brain tumor.~      For half of the patients, fluorescein and intraoperative MRI will be used together during~     surgery. For half of the patients, only intraoperative MRI will be used during surgery. iMRI~     is used as final verification of complete, safe resection in both arms.~   "
78449|NCT02540122|"~     This is a pilot evaluation to assess the feasibility of using novel imaging process to~     characterize lens edge and limbal epithelial thickness profile; lens movement with gaze and~     blink; and conjunctival microvasculature including fractal analysis of microvascular~     perfusion maps and blood flow velocity.~   "
78450|NCT02540109|"~     This Phase II study aims to ascertain the effectiveness of HD-tDCS for adjunctive treatment~     of anomia in chronic aphasia post stroke. Furthermore, it will help explore factors such as~     alternate outcome measures, subject selection criteria, and benefits of extended treatment~     duration. These results will be compared to an existing trial using conventional non-targeted~     tDCS with the same design and outcomes. Patients will be treated with HD-tDCS while~     performing computerized anomia treatment. The basis behind this method is that language~     therapy is mediated by cortical areas that are most effectively activated during the training~     tasks, thus increasing electric stimulation in these areas may improve learning outcomes. To~     better understand the long term benefits of the adjunctive treatment, patients will be~     screened again four weeks and six months after study using the same anomia tests. If HD-tDCS~     shows promising results in increasing the learning outcomes of anomia treatment, a Phase III~     trial can be considered.~   "
78451|NCT02540096|"~     Stroke is a neurovascular event characterized by impaired blood supply to the brain due to~     rupture or obstruction of certain cerebral arteries, which often results in hemiparesis and~     can affect individuals of any age and sex, being prevalent in the elderly population.~      Among the main treatments available for stroke rehabilitation, most of them demands an~     appropriate structure and high-qualified personnel. Searching for more affordable treatment~     options, several studies suggest the use of mental practice with motor imagery as a potential~     therapeutic tool, since it can be performed at any place or any time the patient wishes,~     including their own homes.~      Motor imagery can be defined as the covert cognitive process of imagining a movement of your~     own body(-part) without actually moving that body(-part).~      Within this context, the objective of this study is to investigate the effects of mental~     practice for mobility, gait function and speed and muscle strength of the lower limb in~     subacute post-stroke hemiparesis.~   "
78452|NCT02540083|"~     The aim of this recruitment plan (ADAPT-Enrich) is to collect image and technical data on~     both digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM), along with~     other subject data including histology results from biopsy specimen examination and cancer~     classification data from initially asymptomatic women referred for clinically indicated~     breast biopsy based on suspicious DBT screening breast imaging results. These data will be~     included in a subsequent and prospectively planned pooled analysis described in a separate~     protocol (ADAPT-BIE) examining superiority of DBT to FFDM for breast cancer diagnosis and~     other performance measures.~   "
78453|NCT02540070|"~     Patients undergoing primary total knee replacement will receive either motor sparing knee~     block to be performed by anesthesia or periarticular local anesthetic infiltration at the end~     of surgery by surgeons to assess pain relief as well as capacity to ambulate early. The motor~     sparing knee block will be performed prior to surgery using ultrasonography and the effect of~     adding dexmedetomidine, an alpha 2 agonist to the injectate with regards to prolonging the~     duration of analgesia will be assessed.~   "
78454|NCT02540057|"~     We are investigating the use of the flexor carpi radialis and abductor pollicis longus~     tendons in the use of trapeziectomy and ligament reconstruction with tendon interposition.~     Previous studies have shown clinical equipoise, and we plan to do a randomized controlled~     trial to further assess.~   "
78455|NCT02540044|"~     This proof-of-concept randomized trial evaluates the effectiveness of using an on-line~     decision aid (ANSWER-2) in the decision making to start or switch biologic therapy in~     Canadian patients with rheumatoid arthritis.~   "
78456|NCT02540031|"~     Although adequate bowel preparation is essential for successful colonoscopy, the 23% of~     patients had shown inadequate bowel preparation. Inadequate bowel preparation may results in~     incomplete examination, increased patient's discomfort, decreased polyp detection rates,~     ultimately leading to repeated colonoscopies. One prior study showed that patients reporting~     their last rectal effluents as brown color or solid stool had a 54% chance of having fair or~     poor preparation. Thus, recent consensus guideline suggested consideration of additional oral~     preparation in patients presenting brown effluents on the day of colonoscopy. However, the~     data supporting additional oral preparation is still spares. Therefore, the investigators~     aimed to examine the impact of additional oral preparation on the quality of bowel~     preparation for colonoscopy in patients showing brown effluents on the day of colonoscopy.~   "
78457|NCT02540018|"~     The aim of this clinical trial is to evaluate the safety and efficacy of the novel Luminor®~     paclitaxel drug‐eluting balloon (iVascular, S.L.U., Barcelona, Spain) in inhibiting~     restenosis and in ensuring long‐term patency.~   "
78458|NCT02540005|"~     The main purpose of this study is to analyse the on-going coagulation process after aSAH. For~     investigation the investigators use the rotational thromboelastometry (ROTEM) which is a~     point-of-care test using a variety of activators to provide a targeted and a dynamic analysis~     of coagulation cascade. This is a prospective, observational clinical study done in 16 aSAH~     patients treated in Tampere University Hospital intensive care unit and 16 control patients~     (elective craniotomy due to non-ruptured intracranial aneurysm.~   "
78459|NCT02539992|"~     Randomized evaluation of the ShapeMatch Cutting Guide for primary total knee replacement~     (TKR) in a consecutive series of patients who meet the eligibility criteria.~   "
80811|NCT02509169|"~     An open-labeled, randomized, active-controlled phase II study to investigate clinical~     efficacy and immunoreaction using trans-catheter arterial embolization (TAE) combined with~     p53 gene therapy in treatment of advanced hepatocellular carcinoma (HCC).~   "
78460|NCT02539979|"~     A double blinded randomized controlled study comparing pre-procedural IV Paracetamol versus~     IV placebo (normal saline). The patients will be randomized to either receiving IV~     paracetamol or saline infusions before undergoing radiofrequency lesioning of two levels of~     medial branch nerves of the lumbar facets. The primary outcome will be potential differences~     in pain control. The secondary outcomes will be changes in quality of life (QoL) and~     activities of daily living (ADLs). We will also be comparing potential differences in the~     amounts of post-procedure pain medications taken by the patients in each wing of the study~   "
78461|NCT02539966|"~     The FANTOM II trial is intended to assess safety and performance of the Fantom Bioresorbable~     Coronary Scaffold in native coronary arteries.~   "
78462|NCT02539953|"~     One in ten patients on rivaroxaban therapy have dizziness and reductions in blood pressure.~     The investigators intend to monitor the ambulatory blood pressure of such patients in order~     to assess whether this is a true haemodynamic effect.~   "
78463|NCT02539940|"~     The aim of this observational study is to evaluate the outcomes and safety of the~     Paclitaxel-eluted balloon catheter ELUTAX SV for treatment of peripheral arterial disease~     (PAD) in below-the-knee vessels~   "
78464|NCT02539927|"~     Patients will be treated in accordance with the standard medical practice of the hospital~     where they have been recruited during their participation in this study. No additional~     assessments or tests will be required.~      SAGIT® is a new instrument developed by a group of acromegaly experts to help practicing~     endocrinologists to manage acromegalic patients and disease activity in their clinical~     practice and define acromegaly staging. It reports 5 elements: Signs and symptoms - S;~     Associated comorbidities - A; Growth hormone (GH) concentration - G; Insulin-like growth~     factor 1(IGF-1) concentration -I; Tumour size- T.~      The instrument has been pre evaluated during a qualitative pilot study. The purpose of the~     validation study is to define and validate the scoring of the SAGIT® instrument.~   "
78465|NCT02539914|"~     The purpose of this study is to determine whether it is feasible to use a virtual reality~     task for stroke rehabilitation for training motor and cognitive (attention and memory)~     domains based on the use of positive stimuli, and to evaluate the potential benefits in~     comparison to standard rehabilitation.~   "
78466|NCT02539901|"~     Cochlear implantation enables profoundly deaf children to acquire speech and develop their~     understanding of spoken language. However, there are significant interindividual differences~     in the results obtained with the implant. Given the lack of theoretical knowledge on acoustic~     predictors, cognitive and language to obtain optimum speech recognition with cochlear~     implants associated with a good communicative and language development of deaf children, the~     investigators intend to achieve a preliminary longitudinal study aimed to describe the~     cognitive, communicative and perceptive implanted deaf children.~      The main objective of our study is to describe the cognitive and communicative development of~     deaf children implanted from the pre-implant assessment to 18 months post-implantation, by~     addressing the following aspects:~        -  The psychomotor and cognitive development assessed using the Brunet-Lézine test;~        -  The development of preverbal communication, evaluated using the Early Social~          Communication Scale.~   "
78467|NCT02539875|"~     Although smoking prevalence is decreasing in Hong Kong, there are still 648,800 daily smokers~     10.8% (Census and Statistics Department, 2013) and half will be killed by smoking (Lam, 2012)~     which accounts for over 7,000 deaths per year (Lam, Ho, Hedley, Mak, & Peto, 2001). Smoking~     also accounts for a large amount of medical cost, long-term care and productivity loss of~     US$688 million (0.6% Hong Kong GDP) (Census & Statistics Department, 2001; McGhee et al.,~     2006) . Smoking is a highly addictive behavior and it is difficult for smokers with strong~     nicotine dependence to quit without assistance. On the other hand, reaching and helping the~     many smokers who have no intention to quit is a challenge, because they are unlikely to seek~     professional help from smoking cessation services.~      The Quit and Win programme provides an opportunity to reach and encourage a large group of~     smokers to make quit attempt and maintain abstinence. The Quit and Win model posits that~     smokers participating in the contest will have higher motivation to quit with incentives and~     better social support (Cahill & Perera, 2011). Studies have found that such quitting contests~     or incentive programs appeared to reach a large number of smokers and demonstrated a~     significantly higher quit rate for the quit and win group than for the control group (Cahill~     & Perera, 2008).~      Smoking cessation services in Hong Kong are under-used with more than half (60.9%) adult~     daily smokers who had never used smoking cessation services (Census and Statistics~     Department, 2013). Among these smokers only 9.6% were willing to use the services. Existing~     services mostly require self-initiation to seek the services but smokers general lack the~     will power of initiation. Active referral will help overcome the barriers of self-initiation.~     There is preliminary evidence that active referral of smokers to smoking cessation hotline~     services may increase likelihood of smoking abstinence at 12-month follow-up compared with no~     active referrals (Borland et al., 2008). A recent study has also reported that individuals~     who used the community-based referral were also more likely to quit than those who did not~     (43.6% vs 15.3%, P<0.001) (Haas et al., 2015).~      Therefore, the present study will examine (1) effectiveness of the active referral and AWARD~     approaches, (2) explore the use of CBPR model to build capacity and to engage community~     partners in taking on this important public health issue for sustainability in the community.~     In addition, process evaluation will be conducted to assess the effectiveness of the~     recruitment activity and how it is linked with the overall program outcomes.~   "
78468|NCT02539862|"~     The purpose of this study is to evaluate the effectiveness of the management of chronic~     primary insomnia patients by a computer program guidance of behavioral and cognitive~     therapies for insomnia (BCT-I).~   "
78469|NCT02539849|"~     FOS improve gut colonization by Faecalibacterium prausnitzii in patients with Crohn's disease~   "
78470|NCT02539836|"~     With the rapid development of society and economy, children's simple obesity is the rising in~     the world and has become a chronic disease which is one of the biggest public health~     challenges in the world. It is a serious threat to the health of children and their~     adulthood. The overweight and obesity is induced by the genetic and environmental factors.~     The environmental factors are very important, while the dietary factors are the driving~     factors of many chronic diseases including obesity. This study focus on the dietary~     intervention of childhood obesity to build healthy intestinal flora. The interventing food~     was based on a natural health food - fruit and vegetable fermentation liquid, and combined~     with other probiotic dietary factors, dietary fiber and oligosaccharides. The implementation~     of the study will help to reveal the fuction mechanism of intestinal bacteria in the obese~     children and normal children, and to construct healthy micro environment of intestinal flor.~     According to the positive effect factors, the study will propose a healthy diet and nutrition~     intervention model for obese children, which is significant to social health especially to~     children's health.~   "
78471|NCT02539823|"~     Despite the current available therapies for opioid-dependent patients, most patients relapse.~     This research project focuses on the development of a novel compound, cannabidiol, to~     modulate opioid craving in humans based on animal models showing its selective effectiveness~     to inhibit drug-seeking behavior. The development of a targeted treatment for opioid relapse~     would be of tremendous medical and public health value.~   "
78472|NCT02539810|"~     The ANDORRA study is a, multicenter, prospective, open, randomized, controlled blinded~     endpoint trial (PROBE) comparing two treatment strategies (renal artery stenting +~     standardized and optimized medical treatment [SOMT] versus SOMT alone) of 12 months duration~     in patients with confirmed resistant hypertension (RH) and angiographically proven grade III~     unilateral or bilateral atherosclerotic renal artery stenosis (ARAS) ≥ 60%.~   "
78473|NCT02539797|"~     This study will examine the benefits of transcranial direct current stimulation (tDCS), a new~     tool that is being developed as a safe and non-invasive neurostimulation method, for~     improving neurocognitive and social cognitive functions in schizophrenia. This procedure is~     non-invasive and painless and it results in increase or decrease of spontaneous neuronal~     firing in the brain. Its safety and beneficial effect on cognition has been demonstrated in~     healthy individuals and several clinical populations. In this pilot study, the investigators~     will examine the effect of tDCS on cognitive functions in 40 individuals with schizophrenia.~     Each participant will arrive for three visits, with approximately one week between each~     visit. During the first visit, participants will be interviewed about their psychiatric~     symptoms, personal life experiences, and emotional well being by a specially-trained~     interviewer. On each of the three visits, participants will receive one of three~     stimulations: a type of tDCS designed to increase neuronal firing, an alternative form of~     tDCS designed to decrease neuronal firing, and a sham tDCS (stimulation with no current).~     Immediately following the stimulation, participants will be asked to complete measures of~     mental abilities, including tests presented on a computer screen and paper-and-pencil tests.~     During each visit, participants will also undergo a standard measure of brain activity (EEG)~     while listening to tones. The first visit will last approximately five hours, and the other~     two visits will last approximately four hours each. The project will take approximately two~     years to complete.~   "
78474|NCT02539784|"~     Following the so call honey moon period, motor symptoms of Parkinson's Disease (PD) become~     difficult to control with dopaminergic treatments alone. Deep brain stimulation (DBS) of the~     subthalamic nucleus and internal globus pallidus helps to treat fluctuating parkinsonian~     patients restoring a decent quality of life. However, DBS need a long, complex and invasive~     surgery to succeed. Thus, there is a critical need to develop alternative treatments, more~     accessible and less invasive. Thoracic posterior spinal cord stimulation has been used for~     decades to treat chronic neuropathic pains. Safety and efficacy have already been~     demonstrated in neuropathic pain. Experimentally, SCS has also demonstrated to improve~     locomotor activity in two different rodents' models of parkinson's disease. The purpose of~     this study is to determine whether thoracic SCS is safe and could induce a benefit motor~     parkinsonian symptoms without any impact on cognitive function and axial disability.~   "
78475|NCT02539771|"~     Hypothesis is that the occurrence of nocturnal Vaso-Occlusive Crisis (VOC) and priapism in~     adults might be related to episodes of nocturnal desaturation secondary to a sleep apnea~     syndrome. Investigator hypothesize that chronic biological consequences of Obstructive Sleep~     Apnea (hypercoagulability, endothelial dysfunction ...) favour VOC and acute manifestations~     (nocturnal desaturation) favour nocturnal VOC.~      The confirmation of this hypothesis will lead investigator to propose a systematic screening~     of obstructive sleep apnea (OSA) in patients with nocturnal VOC. Moreover, systematic~     treatment of OSA in sickle cell patients could help significantly reduce the number and~     severity of nocturnal VOC.~   "
78476|NCT02539758|"~     Lowering intraocular pressure remains the mainstay of therapy in the management of glaucoma.~     The effect of ocular massage on intraocular pressure in patients with acute primary angle~     closure was the important thing.This was a prospective study, in which 20 eyes from 20~     patients had acute angle closure. When they went to the hospital, ocular massage was~     performed without any medication. Intraocular pressure was detected by Goldmann tonometer,~     and Lenstar LS900 optical biometry observed changes of anterior chamber depth before and~     after ocular massage. Anterior chamber depth, anterior chamber angle and ciliary body were~     observed by Ultrasound biomicroscopy after massage, and anterior chamber angle was also~     checked by gonioscope after massage.~   "
78477|NCT02539745|"~     This study investigated whether vitamin D receptor gene polymorphism is altered in primary~     open-angle glaucoma subjects carrying the risk allele and vitamin D deficiency is an~     important factor in the development of glaucoma. Primary open-angle glaucoma patients and~     age-matched people in the Han population were enrolled. Serum levels of 1a,~     25-Dihydroxyvitamin D3 were measured by enzyme-linked immunoabsorbent assay. Vitamin D~     receptor polymorphic analysis was studied by real-time polymerase-chain reaction high~     resolution melting analysis.~   "
78478|NCT02539732|"~     Several types of spontaneous breathing trials (SBTs) have been proposed to evaluate when a~     patient is ready to be weaned from the ventilator based on breathing pattern measurements.~     The T-piece technique allows clinicians to calculate breathing patterns accurately but many~     prefer to use minimal levels of assistance, which unfortunately modifies breathing pattern.~     The interest of Neurally Adjusted Ventilatory Assist (NAVA) is that tidal volume (Vt)~     supposedly represents what the patient really wants: without disconnecting the patient from~     the ventilator, it may be possible to determine what is the real need and whether the patient~     is able to maintain Vt without support. The aims of the study are as follows: to test whether~     the changes in Vt after the removal of a standardized level of NAVA assistance (ΔVt) can~     predict weaning outcome; to compare the proposed titration of effort in NAVA (occlusion) with~     Patient-Ventilator Breath Contribution (PVBC) and titration using the Pmusc/Eadi index (PEI)~     relating the pressure generated by the respiratory muscles (muscular pressure; Pmusc) to the~     electrical activity of the diaphragm (EAdi); to assess the effect of PEEP on the change in~     Vt; and to evaluate EAdi after extubation. Patients ventilated for at least 24 hours who are~     ready to undergo an SBT will be included. Patients younger than 18 years of age and/or who~     have a contraindication to NAVA catheter insertion and/or surgical patients expected to be~     extubated within 12 hours will be excluded. After a baseline inclusion period with the~     pre-enrollment mode of ventilation, the standardized NAVA level will be applied for 20~     minutes, during which both Patient-Ventilator Breath Contribution (PVBC) and PEI will be~     calculated. After the NAVA trial, a period of Continuous Positive Airway Pressure (CPAP) 5~     (2-3 minutes) followed by a period of CPAP 0 (2-3 minutes) (both with NAVA gain 0) will be~     performed in order to record the difference with Vt during standardized NAVA (ΔVt). At the~     end of this period, the patient will be switched back to the baseline settings for 30~     minutes-3 hours. After this period, the patient will perform an SBT with CPAP 0 or CPAP 5 for~     1 hour. At the end of the SBT, the attending physician will decide whether or not to extubate~     the patient according to standard criteria and blinded to the ΔVt results. Ultimately,~     patients will be classified as success or failure and the ΔVt will be compared between~     these two groups.~   "
78479|NCT02539719|"~     This is a Phase 1a/1b study of SC-003 as a single agent and in combination with ABBV-181 in~     patients with platinum-resistant/refractory ovarian cancer. SC-003 is an antibody-drug~     conjugate (ADC) comprised of a monoclonal antibody linked to a potent chemotherapy. ABBV-181~     is a humanized, recombinant, mAb that binds to cell surface expressed programmed cell death 1~     (PD-1).~   "
78481|NCT02539693|"~     Sacrococcygeal local anesthesia was shown to reduce the time spent in the operating room as~     well as in the recovery room. In addition, decreased hospital stay and postoperative~     analgesic consumption.~      Given the effectiveness of sacrococcygeal local anesthesia in pilonidal sinus surgery, it~     would be valuable to study the effect of the local anesthesia with 75µg/mL of clonidine~     versus 150µg/mL.~   "
78482|NCT02539680|"~     The aim of the present study is to study the expression of the various phosphate transporters~     in patients with normal or moderately impaired renal function or in patients on dialysis. In~     particular, the investigators want to clarify whether NaPi-IIb expression level decreases in~     CKD patients, which would render it a potentially inadequate pharmaceutical target in these~     patients.~   "
78483|NCT02539654|"~     The purpose of this study is to describe the pharmacokinetics (PK) of EXE844 Sterile Otic~     Suspension, 0.3% following a single bilateral ototopical dose in pediatric subjects,~     immediately after bilateral tympanostomy tube surgery.~   "
78484|NCT02539641|"~     The study evaluates the gastric emptying by scintigraphy in patients that had bariatric~     surgery (RYGB of gastric sleeve) comparing patients with successful and unsuccessful weight~     loss and in patients before and after the placement of a duodenal-jejunal bypass liner.~      Additional, after bariatric surgery gut hormones that influence the gastric emptying rate are~     determined.~   "
78485|NCT02539628|"~     The investigators believe sufficient spread to all nerves within the adductor canal—and~     thereby sufficient analgesia—can only be obtained by bolus injections and not by continuous~     infusions via a catheter. The aim of the study is to investigate whether an adductor canal~     block performed as repeated intermittent boluses provides superior pain relief to continuous~     infusion. The investigators hypothesize that adductor canal block performed as intermittent~     boluses via a catheter will reduce morphine consumption and pain as well as enhance~     ambulation and muscle strength compared with continuous infusion.~   "
78486|NCT02539615|"~     The purpose of this study is to measure the performance of the ForeCYTE Breast Aspirator for~     the collection and processing of Nipple Aspirate Fluid (NAF) specimens for cytology.~     Including collecting, processing and shipping samples, training staff, processing samples,~     sample interpretation and accurate and timely reporting in a manner resembling routine~     clinical use. The study will include a subset of patients who are known carriers of a BRCA~     germline mutation. NAF from this subset will be submitted for molecular testing in addition~     to cytology.~   "
78487|NCT02539602|"~     This trial evaluated the impact of N2K, a three-year quasi-experimental study to delay sexual~     initiation and increase condom and contraception use among high school students. The program~     was administered to treatment students beginning in the fall of 2012 (9th grade) and~     continued through the spring of 2015 (11th grade). The purpose of this study was to measure:~     1) the impact of N2K on sexual initiation at the end of the three-year program and 2) the~     impact of N2K on condom or contraception non-use at the end of the program.~   "
78488|NCT02539589|"~     The purpose of the study is to determine the impact of the offer to participate in Becoming a~     Responsible Teen (BART) (treatment) relative to the offer to participate in Healthy Living~     (control) on two self-reported sexual behaviors (condom use and frequency of sex) six months~     after the end of treatment.~   "
78489|NCT02539576|"~     The abacavir (ABC)/dolutegravir (DTG)/lamivudine (3TC) 600 milligrams (mg)/50 mg/300 mg~     fixed-dose combination (FDC) tablet is currently approved in the United States (US) and~     Europe. Although the pharmacokinetics (PK), safety and tolerability of ABC/DTG/3TC FDC~     tablets have been extensively studied in subjects not of Japanese heritage, these parameters~     have not been exclusively assessed in Japanese subjects. To support the marketing application~     in Japan, this single-dose, open-label study will characterize the PK, safety and~     tolerability of ABC/DTG/3TC FDC tablet in adult Japanese healthy subjects. A maximum of 12~     subjects will be enrolled such that approximately 10 evaluable subjects complete the study.~     The study will consist of a screening, treatment phase (single oral dose under the fasted~     state) and follow-up visit (within 7-14 days of the last PK sample collected). The total~     duration of the study for each subject will be approximately up to 48 days.~   "
78490|NCT02539563|"~     Labor patients who meet inclusion and exclusion criteria will be consented to be participate~     in this study to determine if the use of a peanut shaped birthing ball reduces the length of~     labor and reduces the incidence of cesarean section. Subjects will be randomized at the time~     of consent to either use the birthing ball or not use the birthing ball from the time of~     labor analgesia until complete cervical dilation.~   "
78491|NCT02539550|"~     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of~     PF-06266047 after first-time administration to healthy adult subjects.~   "
78492|NCT02539537|"~     French national multicentric phase III trial evaluating chemotherapy with Folfirinox or~     gemcitabine in locally advanced pancreatic carcinoma~   "
78493|NCT02539524|"~     The aim of this study is to investigate weather the breathing exercises of Yoga are effective~     in altering clinical impact, anxiety, depression and quality of life in Chronic Obstructive~     Pulmonary Disease patients.~   "
78494|NCT02539511|"~     Alcohol use disorders remain a significant public health problem. The pharmacological~     facilitation of behavioral treatment represents a promising strategy for addressing~     disordered drinking. Alcohol use disorders are recognized to be associated with various~     vulnerabilities that complicate the course of treatment and that may be amenable to glutamate~     modulators. The purpose of this randomized, double-blind, controlled trial is to test various~     glutamate modulators in conjunction with motivational enhancement therapy (MET) for alcohol~     use disorders.~   "
78495|NCT02539498|"~     Bone lesions are frequent in primary hyperparathyroidism (PHPT). Conventional measurement by~     Dual-Energy X-ray Absorptiometry does not provide enough information about the bone impact of~     excessive parathyroid hormone (PTH) secretion. High-Resolution peripheral Quantitative~     Computed Tomography (HR-pQCT) assesses separately cortical and trabecular bone sites as well~     as geometric characteristics of peripheral skeleton. In postmenopausal women, HR-pQCT has~     shown that decreased microarchitectural parameters are associated with reduced bone strength~     independently of BMD. The purpose of this study is to characterize the impact of PHPT in~     cortical and trabecular bone measured by HR-pQCT in postmenopausal women with PHPT followed~     for one year, in comparison with control postmenopausal women.~   "
78497|NCT02539472|"~     Mycosis fungoides (MF) is an epidermotropic cutaneous T cell lymphoma characterized by the~     accumulation of CD4+ T-lymphocytes in the skin. Early MF presents as erythematous patches~     and/or infiltrated plaques. The diagnosis of early MF is a major diagnostic challenge and the~     differential diagnosis with inflammatory dermatoses is often very difficult. The~     histopathological diagnosis is also difficult and delayed. Therefore, it is important to~     develop biomarkers and/or a combination of biomarkers in order to improve the early~     diagnostic of MF.~      In a previous trial, investigators included 490 patients in a study aiming at identifying~     skin biomarkers of early MF. Several activating and inhibiting KIRs were found to be~     interesting for the skin diagnostic of MF, mainly KIR2DL4 and KIR3DL2. Investigators later~     evaluated blood biomarkers in patients with erythrodermic MF and Sezary Syndrome (SS). This~     French institutional study demonstrated that the identification by PCR of a combination of 4~     blood markers (CD158k/KIR3DL2, PLS3/T-Plastin, Twist and NKp46) allowed a reliable diagnosis~     of lymphoma in erythrodermic patients. This previously published study interestingly showed~     that 30% to 50% of patients with early MF expressed at least one of these biomarkers in the~     blood (unpublished data). Other groups also recently showed that TOX can be a diagnostic tool~     for MF.~      The aim of this study is to establishing an accurate blood diagnosis for early suspected MF~     by demonstrating that newly identified biomarkers or their combination [5 cutaneous KIR~     receptor markers (KIR2DS1, KIR2DS3, KIR3DL1, KIR2DL4, KIR3DL2) and 5 blood biomarkers (TOX,~     Twist-1, PLS3/T-plastin, KIR3DL2, NKp46)] are differentially expressed by patients with MF~     and patients with inflammatory dermatoses closely resembling MF lesions.~      Statistical analysis will establish the best combination of blood biomarkers allowing the~     differentiation between the two groups of patients, combination that could represent a~     suitable diagnostic tool for early MF.~   "
78498|NCT02539459|"~     The purpose of this research study is to see if oral everolimus is tolerable and effective in~     the treatment of sporadic Angiomyolipomas (AMLs). AMLs are the most common non-cancerous~     tumor of the kidney. They are composed of blood vessels, muscle cells and fat~     cells.Everolimus is already an approved drug for several other diseases like kidney cancer,~     but is being studied now specifically to see if it is helpful for people with AML.~   "
78499|NCT02539446|"~     Inherent with intricate allocation of brain resource and attention shift,~     postural-suprapostural task is defined as postural control takes place while the other~     concurrent task is being performed. Recent studies have indicated that attentional focusing~     alters attention allocation in the brain as well as motor performance of a~     postural-suprapostural task. Also, most studies have demonstrated benefits of inducing an~     external focus relative to internal focus for motor performance. However, postural difficulty~     might be a critical factor for choosing an appropriate focusing strategy, and the strategy~     used in a particular difficulty level do not always generalize to other difficulty levels.~     Besides, despite a lot of studies have been done, current findings are confined to behavioral~     observations in young healthy adults for lacking direct neural evidence. With the uses of~     H-reflex, event-related potential and behavioral measures, the purpose of the 3-year research~     project is to investigate the differences in performance quality and intrinsic neural~     mechanisms of a postural-suprapostural task for older adults and patients with Parkinson's~     disease, by adopting external and internal strategies for suprapostural task under different~     posture difficulties. In the first year, the investigators will characterize suprapostural~     focusing effect on reciprocity of a postural-suprapostural task, with a special focus on~     modulation of motoneuron excitability in sitting and standing posture for healthy young and~     older adults using H-reflex technique. In the second year, the adaptive selection of~     suprapostural focusing strategy will be investigated for patients with Parkinson's disease by~     varying the standing surface (stable/unstable surface). In the third year, the investigators~     will investigate suprapostural focusing effect on brain resource allocation for patients with~     Parkinson's disease, in light of event-related potential and movement-related potential. The~     present project is expected to have significant contributions not only to gain a better~     insight to neural correlates of concurrent postural and motor suprapostural tasks with~     internal/external focusing strategy under different posture difficulty, but to optimize~     treatment strategy for older adults and patients with Parkinson's disease with balance or~     multi-tasking disturbances.~   "
78500|NCT02539433|"~     Imaging of neuroendocrine (NETs), such as carcinoids and pheochromocytomas (PHEOs), is~     suboptimal, limiting curative treatment. The investigators wanted to explore the use of PET~     and F-DOPA i.v. for the localization of these types of neoplasms. The investigators used a~     similar protocol as they had used for PET (Positron emission tomography) or FDG~     (Fludeoxyglucose) imaging in oncologic patients. F-DOPA, prepared according to United States~     Pharmacopeia (USP) guidelines, was approved by the North Shore University Hospital Radiation~     Safety Committee in 1989 and 1994 for the study of neurological diseases and used~     uneventfully.~   "
78501|NCT02539420|"~     Though BiPAP is an increasingly common tool used by pediatric critical care physicians and~     there is promising data suggesting a role for BiPAP in the management of status asthmaticus,~     more information is needed to more definitively clarify the extent of its benefit, as well as~     when during an asthma exacerbation and in whom it is the most beneficial. In this study,~     which is among the first randomized studies of BiPAP use for status asthmaticus in the~     pediatric population, the investigators hope to better elucidate these issues to help guide~     clinicians' future management decisions.~   "
78502|NCT02539407|"~     Concentrations and effects of anti-infectives in critically ill children are unpredictable~     and the risk of under-exposure may be associated with poor clinical outcomes. In addition,~     between-subject variability (BSV) is known to be substantial in critically ill children.~     Rationalisation of anti-infectives in children is therefore desirable.~      The investigators aim to investigate, using a population approach, the pharmacokinetics (PK)~     and pharmacodynamics (PD) of anti-infectives including PK/PD targets (fT(%) > minimal~     inhibitory concentration (MIC)) and PD endpoints (clinical outcomes) in critically ill~     children. Covariates The effects of covariates on anti-infectives PK and PK/PDs are~     investigated in order to better explain the BSV and to ultimately suggest individualized~     dosage regimens.~      It will be a prospective PK study including 11 anti-infectives antibiotics. Six blood samples~     were taken from each patient during dosing interval. The primary PK/ PD targets were~     anti-infectives concentrations above the MIC of the pathogen at both 50% (50% f T>MIC) and~     100% (100% f T>MIC) of the dosing interval. The investigators used skewed logistic regression~     to describe the effect of anti-infectives exposure on patient outcome.~   "
78503|NCT02539394|"~     The purpose of this study is to determine what effect intraoperative topical steroids have on~     reducing swallowing difficulty following Anterior Cervical Discectomy and Fusion surgery.~   "
78504|NCT02539381|"~     Visual impairment can affect up to 70% of stroke survivors, but many do not have their vision~     adequately assessed in hospital. An unidentified visual defect can cause significant problems~     for recovery and quality of life. The Stroke Vision app (an application currently scaled for~     a 10 Android tablet) has been developed to act as a screening tool for visual problems in~     stroke survivors; to help identify visual problems earlier and thereby improve rehabilitation~     outcomes. The app includes a suite of tests for assessing the patient's acuity, their visual~     fields and to aid in the identification of visual neglect / inattention. Furthermore, it~     includes educational information on visual stroke in order to better educate staff, patients~     and their carers. This study seeks to validate the novel digital assessments included in the~     Stroke Vision app against the current methods used for screening (clinical examination by~     confrontation field testing). Both screening measures will be compared with the gold standard~     methods for visual assessments, Octopus perimetry for fields and paper-based methods for~     visuospatial neglect~   "
78654|NCT02537392|"~     The purpose of this study is to determine whether daily oral supplements of vitamin B complex~     along with folic acid or supplements of iron plus folic acid given to women during~     peri-conception can reduce the risk of congenital heart disease when compared with folic acid~     alone.~   "
78505|NCT02539368|"~     This is a post-marketing observational study of patients with Inflammatory Bowel Disease~     (specifically, Crohn's disease or Ulcerative Colitis) who have been prescribed Inflectra~     (infliximab) or Remicade (infliximab) for treatment. Inflectra is a biosimilar medicine to~     Remicade, meaning it is a biologic medicine that contains the same active substance as~     Remicade (infliximab). The key study objectives are as follows:~        -  To characterize the population and drug utilization patterns of patients treated with~          Inflectra for Crohn's Disease (CD) or Ulcerative Colitis (UC) in the context of standard~          of care Remicade~        -  To assess the safety of Inflectra up to a 2-year follow-up period in the treatment of~          patients with CD or UC in the context of standard of care Remicade~        -  To assess the effectiveness of Inflectra in the treatment of patients with CD or UC in~          the context of standard of care Remicade~        -  To evaluate the immunogenicity profile of Inflectra in the treatment of patients with CD~          or UC~        -  To evaluate patient-reported outcomes (PRO) including quality of life (QoL), work~          productivity and healthcare resource utilization (HRU) in patients treated with~          Inflectra for CD or UC~   "
78506|NCT02539355|"~     Obesity is a risk factor for several common cancers, including those of the breast, colon,~     liver, and pancreas. Proposed molecular links between obesity and these types of cancer~     include systemic inflammation, hyperinsulinemia, and changes in the serum concentrations of~     sex steroid hormones and adipokines. All of these are strongly linked to low-grade chronic~     inflammatory processes in expanded adipose tissue. The objective of this proposal is to test~     the hypothesis that adipose tissue inflammation can be reduced by the foods we eat.~   "
78507|NCT02539342|"~     The purpose of this study is to determine if the administration of Caphosol rinse, at the~     start of chemotherapy, will prevent the development of mucositis (greater than or equal to~     grade 2 in children, adolescents and young adults. This is a randomized, controlled trial.~   "
78508|NCT02539329|"~     Sensory neuronopathies affect sensory neuron in the posterior spinal ganglion. They are~     responsible for pain, balance disorder (ataxia) and the use of hands. They depend on multiple~     etiologies. In a retrospective study, the investigators showed that the anti-FGFR3 antibody~     is a diagnostic marker of a subset of sensory neuronopathies. The investigators believe that~     other antibodies can be discovered in patients who remain seronegative changing.~      However, the study is retrospective and only a small number of patients could be identified.~     Several points therefore need to be clarified or confirmed in a second prospective study.~   "
78509|NCT02539316|"~     Parenteral nutrition (PN) is part of supportive care in oncology Pediatric when the patient's~     nutritional status justifies it and enteral is impossible. In the literature, hepatotoxicity,~     cholestasis type, standard emulsions of soy oil-based (type Médialipide®) is described in the~     context of a long-term PN especially in premature infants. It results in an increase in~     gammaGT. The most recent use of lipid emulsions containing Omega 3 (Smoflipid), was studied~     in the adult population and in the preterm in the PN on short and long, with the finding of a~     hepatoprotection. Investigators do not find a single retrospective study about it in~     Pediatric Onco-Hematology. No prospective studies have been performed in the population of~     Onco-Hematology. The objective of this study is to evaluate the impact of the use of~     SMOFlipid® in parenteral nutrition on early occurrence of cholestasis compared with~     Médialipides in a short-term use of parenteral nutrition in an Onco-Hematology pediatric~     population.~   "
78510|NCT02539303|"~     This is a feasibility pilot study to evaluate the impact of local delivery of Yamani-15/5~     (combination of L-Lactic acid 15% and D-Gluconic acid 5%) on vascular calcification of lower~     extremities in patients with severe peripheral arterial disease (PAD) who were deemed to have~     unreconstructable arterial disease and who have already been scheduled to undergo limb~     amputation (below knee or above knee amputation).~   "
78511|NCT02539290|"~     The purpose of this study is to determine whether preovulatory uterine flushing with~     physiological saline is effective in the treatment of unexplained infertility.~   "
78512|NCT02539277|"~     Study topic：A comparative effectiveness research on Jinyebaidu granule in treating patients~     with acute upper respiratory infection: A double blind, double dummy, randomized, controlled~     trial. It is a post-marketing clinical study to evaluate effectiveness, safety and~     cost-effectiveness on Jinyebaidu granule in treating acute upper respiratory infection.~      Objectives of Study：This study aims to evaluate effectiveness, safety and cost-effectiveness~     on Jinyebaidu granule in treating patients with acute upper respiratory infection.~      Study design：multi-center double-blind, double-dummy, randomized, controlled trial~   "
78513|NCT02539264|"~     In this study the investigators will analyze the influence of smoking, benzodizepine use, and~     obesity among patients with severe Obstructive Sleep Apnea (sOSA).~   "
78514|NCT02539251|"~     Early detection and intervention for developmental delays are crucial in promoting healthy~     child development, hence the need for formal screening. In the Arabic speaking population~     developmental screening tools are scarce in the native language and there is a need for such~     a tool for pediatricians and health care workers to use routinely.~      This study aims to translate, adapt and validate the newest version of ASQ (ASQ-3) to Arabic~     (A-ASQ-3) based on the previously published study showing that ASQ-2 was culturally~     sensitive.~      The previously translated A-ASQ-2 will be revised and updated to match the new ASQ-3, then~     revised by experts in child development. Questionnaires will be adapted and field-tested on~     15 subjects per age group (total of 75). For validity, the revised version will be tested on~     500 Lebanese children (100 children per age group) selected from all Lebanese governates.~      It is expected to generate a culturally adapted and validated Arabic tool for screening~     children for any developmental delay up to 3 years of age. This tool once published will be~     available for use by primary care providers and caregivers in Arabic speaking countries. It~     may be used to screen children for developmental delay as early as 7 months therefore~     prompting prevention of further delay by starting early intervention and promoting child~     development.~   "
78617|NCT02537886|"~     The Patient Centered Virtual Multimedia Interactive Informed Consent tool (VIC) will be~     developed as a patient-centered web-based mobile application and will be able to run on~     mobile devices. The development of VIC is to create a reusable infrastructure for integrating~     the informed consent process into clinical care and the clinical workflow in a way that~     enhances patient comprehension while improving the efficiency of obtaining patient consent.~   "
78515|NCT02539238|"~     Objectives: The primary objective of this project is to assess whether the implementation of~     a new cardiopulmonary resuscitation (CPR) training program (longitudinal training with~     real-time feedback) can improve CPR quality of healthcare providers compared with traditional~     training method. The secondary objective is to identify whether the implementation of the new~     training program will result in cost-effectiveness.~      Design: Randomized trial to compare new training program with tradition training method and~     cost-effectiveness alongside this trial~      Participants and setting: Paediatric healthcare providers in Emergency Department at Alberta~     Children's Hospital. Subjects will be enrolled in either intervention (new training program)~     or control (traditional training program) by random.~      Statistical analysis: Investigators will conduct chi-square test and independent t-test to~     compare the proportion of excellent CPR and 3 metrics of CPR quality of intervention group~     with control group at the end of 12-month interval. A multi-level logistic regression and~     linear regression models will be used to assess the effect of training method and time on~     proportion of excellent CPR and 3 metrics of CPR quality. Investigators will also conduct a~     full-economic evaluation in a health care system prospective. cost-effectiveness will be~     expressed as cost per increased CPR excellence according to incremental cost-effectiveness~     ratio (ICER). A one-way sensitivity analysis and a probabilistic sensitivity analysis will be~     conducted to deal with uncertainty in effects and costs.~      Conclusion: The new CPR training program will serve as an example of competency-based~     psychomotor skill training program and help healthcare providers to improve quality of CPR,~     and potentially improve the survival of children with cardiac arrest. The results of the~     studies might provide evidence to inform and update in resuscitation education guideline to~     change the way of CPR training and improve the cost-effectiveness of CPR training program.~   "
78516|NCT02539225|"~     The main purpose of this study is to evaluate the effectiveness of S-1 and oxaliplatin with~     or without ramucirumab as first line therapy in participants with metastatic gastric or~     gastroesophageal junction (GEJ) adenocarcinoma.~   "
78517|NCT02539212|"~     According to randomized controlled trial requirement, the therapeutic effectiveness of~     cooled-probe microwave ablation and radiofrequency ablation on early-stage hepatocellular~     carcinoma is compared to find a better approach for minimally invasive thermal ablation.~   "
78518|NCT02539199|"~     The purpose of this study is to investigate the effectiveness and safety of vaginally~     administered misoprostol (Misodel) versus per orally administered misoprostol (Cytotec) in~     induction of labour in nulliparous women.~   "
78519|NCT02539186|"~     The platelet rich plasma (PRP) is a new and potential treatment for patients with kinds of~     musculoskeletal disorders. Although few studies have showed beneficial effect of PRP for~     regeneration of peripheral neuropathy in animal study, the associated study in human is rare.~   "
78520|NCT02539173|"~     1. INTRODUCTION AND MAIN OBJECTIVES The incidence of diaphragmatic paralysis after an~          inter-block scalénique varies between 30 and 100% in the literature. Its clinical impact~          is mostly absent and paralysis regresses after the block lifted. When it is suspected,~          it can be diagnosed by a chest radio, showing an elevation of the dome.~           The objective of this study is to evaluate the incidence of diaphragmatic paralysis by~          measuring the thickness diaphragmatic as quantitative assessment of diaphragmatic~          contraction noninvasive ultrasound scan and feasibility of this measure in SSPI unit~          (post-interventional monitoring unit) with scan (ultrasound) in the usual way used for~          the block under ultrasound scan.~        2. STUDY TYPE Prospective, single-center clinical study routine care involving 50~          consecutive patients scheduled to undergo surgical procedures in the area of the~          shoulder or arm for which locoregional analgesia inter-block type scalénique or~          supraclavicular ultrasound scan is indicated below.~        3. START OF THE STUDY February 2014 with an expected duration of six months.~   "
78521|NCT02539160|"~     Patients with diabetes mellitus (DM) are at increased risk of atherothrombotic events.~     Importantly, DM is a key risk factor for the development of chronic kidney disease (CKD),~     which further enhances atherothrombotic risk. Clopidogrel is the most widely used platelet~     P2Y12 receptor inhibitor. However, despite its clinical benefit, patients with DM and CKD~     frequently experience recurrent atherothrombotic events. Ticagrelor is an oral, reversible,~     non-competitive P2Y12 receptor inhibitor with more potent and consistent platelet inhibition~     than clopidogrel. In large-scale clinical investigation, ticagrelor significantly reduced~     ischemic events to a greater extent than clopidogrel, a finding that was consistent also~     among DM patients. To date there has been no analysis on the efficacy of ticagrelor in DM~     patients according to CKD status. Moreover, although PD studies showed enhanced platelet~     inhibition associated with ticagrelor, it is unknown how this may be affected by CKD status.~     Ultimately, how PK/PD profiles of different ticagrelor dosing regimens may be affected by DM~     and CKD status is also unknown. The proposed study is aimed to show the impact of CKD status~     among patients with DM and CAD on PD and PK profiles of ticagrelor used at 2 doses (90mg bid~     and 60mg bid) in the setting of a prospective, randomized, cross-over trial.~   "
78522|NCT02539147|"~     Activation of caspase-4 and human caspase-5 (orthologs of caspase-11 in mice) in innate~     immune cells.~   "
78523|NCT02539134|"~     The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of~     multiple rising doses of TAK-935 in healthy participants.~   "
78524|NCT02539121|"~     In this study, a single blind randomized trial with third party evaluation is carried out in~     order to compare the postpartum blood loss when Ren Mai 6 point is stimulated and when this~     point is not stimulated.~      Investigators focus on measuring the volume of postpartum blood during the third stage of~     labor and during the first two hours after birth. A significant reduction in the volume of~     bleeding would imply a reduction in the rate of postpartum hemorrhage (PPH) (more than 500~     ml) and the rate of severe PPH (more than 1000 ml).~      The principal outcome of the study is the volume of postpartum blood, this volume is measured~     by the midwife who is responsible of the birth. Collection of lost blood is initiated~     immediately after birth of the baby by passing a blood collection drape under the woman's~     buttocks.~      The secondary outcomes are the influence of acupuncture in the placental expulsion time, and~     the influence of the predictor variables in the bleeding volume and in the placental~     expulsion time: primiparity or multiparity, number of gestation including abortions, doses of~     oxytocin during labor, maternal age, maternal weight in the beginning of the gestation,~     maternal ponderal gain during pregnancy, date of the last blood test during pregnancy and~     value of hemoglobin and hematocrit, spontaneous labor or induction by means of oxytocin or~     prostaglandins, spontaneous or artificial rupture of membranes, first stage of labor~     duration, second stage of labor duration, hours since rupture of membranes, hours since~     epidural analgesia, volume of serotherapy during labor, and newborn weight. Possible~     puerperal complications or security problems, the degree of Satisfaction of the Mother and~     the degree of ease with which the acupuncturist administered the treatment are also secondary~     outcomes.~   "
78668|NCT02537210|"~     The purpose of this study is to determine whether aminosalicylic acid (ASA) can be safely~     withdrawn in patients with long-standing clinical inactive UC.~   "
78525|NCT02539108|"~     The study will evaluate the safety and immunogenicity of the 2015-2016 formulation of Fluzone~     Quadrivalent vaccine, administered in a 1- or 2-dose schedule, in accordance with the~     Advisory Committee on Immunization Practices (ACIP) recommendations, in children 6 months to~     < 9 years of age.~      Objective:~        -  To describe the safety of the 2015-2016 formulation of Fluzone Quadrivalent vaccine,~          administered in a 1- or 2-dose schedule, in accordance with ACIP recommendations, in~          children 6 months to < 9 years of age.~      Observational objectives:~        -  To describe the immunogenicity of the 2015-2016 formulation of Fluzone Quadrivalent~          vaccine, administered in a 1- or 2-dose schedule in accordance with ACIP~          recommendations, in children 6 months to < 9 years of age.~        -  To submit available sera from each subject to Center for Biologics Evaluation and~          Research (CBER) for further analysis by the World Health Organization (WHO), the Centers~          for Disease Control and Prevention (CDC), and the FDA to support formulation~          recommendations for subsequent influenza vaccines.~   "
78526|NCT02539095|"~     The primary objective of this study is to confirm the superiority of intra-articular collagen~     injection in patients with knee joint pain compared to the control group. 100mm VAS is used~     to measure the pain of the subjects 24 weeks after the procedure.~   "
78527|NCT02539082|"~     The primary objective of this study is to evaluate the safety and efficacy of collagen~     injection in patients with plantar fasciitis~   "
78528|NCT02539069|"~     A clinical trial to evaluate the long-term efficacy and safety of Chondron (Autologous~     cultured Chondrocyte) administered through arthroscopy from the drug's 48 weeks efficacy and~     safety evaluation with 96 weeks follow-up in patients with knee cartilage defects.~   "
78529|NCT02539056|"~     A clinical trial to evaluate the long-term efficacy and safety of a CHONDRON (Autologous~     cultured Chondrocyte) for 48weeks, and additional 96weeks in patients with cartilage defects~     in their knees.~   "
78530|NCT02539043|"~     The aim of this study is to evaluate the effect of cavitation ultrasound focused on localized~     adiposity and its effects associated with stereodynamic lymphatic drainage. The investigators~     aim also to know if this procedure will influence the biochemical profile of the individuals~     concerned, as well as whether it will be found difference between the group that will receive~     focused ultrasound cavitation associated with stereodynamic drainage and the group will~     receive only focused cavitation ultrasound.~   "
78531|NCT02539030|"~     This study was designed to evaluate the efficacy and safety of a modified microfracture using~     collagen, and to compare them with those of a simple microfracture to prove the~     non-inferiority of the modified microfracture using collagen in patients with cartilage~     defects in their knees.~   "
78532|NCT02539017|"~     As a special type of breast cancer, the triple negative breast cancer has the characteristics~     of high recurrence rate (2 years after surgery), high distant metastasis rate, poor prognosis~     and short survival time. No matter at home or abroad, the clinical researches of the triple~     negative breast cancer are mainly focused on finding new drugs and new treatment strategies~     in order to reduce its recurrence and distant metastasis rate. The DC/CIK cell immunotherapy~     combined with chemotherapy in the clinical study of metastatic triple negative breast cancer~     has already confirmed benefit. This study is based on the theory that the optimal timing of~     cellular immunity is while the host tumor load is under the smallest state. Put forward the~     hypothesis that the DC/CIK cell immunotherapy combined with chemotherapy may improve the~     disease-free survival and overall surviva after the triple negative breast cancer operation.~     The investigators intends to use the RCT, observing the clinical significance of cellular~     immune adjuvant therapy of triple negative breast cancer in 340 patients with TNBC. Do the~     safety evaluation of cellular immunity in the adjuvant treatment of breast cancer treatment,~     explore the clinical strategies for breast cancer immunotherapy.~   "
78533|NCT02539004|"~     Urolithiasis is a universal problem, a large part of patients will be affected by multiple~     stones throughout their lifetime, with estimated recurrence rates of 75% within 20 years. The~     high recurrence rate requires an increasing amount of imaging follow-up. US-NCCT real-time~     fusion (Fusion) enables lesion assessment and follow up using both modalities as reference~     for each other. Our study proposes a novel approach for short term follow up of patients~     using Fusion instead of repeat NCCT exams.~      the goal of the study is to create an initial proof of concept that Fusion is effective for~     follow up of known urinary stones.~      the study is a prospective study on Patients with an obstructing ureteral stone found on a~     NCCT. Patients will undergo Fusion (using General Electric Logiq E9) after NCCT. The primary~     endpoint was the ability to locate the ureteral stone using US with guidance of the NCCT as a~     Road Map.~   "
78534|NCT02538991|"~     One out of three adult females suffer from daily urinary incontinence. Two thirds of urinary~     incontinence is physical activity-related stress urinary incontinence (SUI). If the~     first-line treatment for SUI, training of pelvic floor muscles, is insufficient, treatment~     options are suburethral sling operation or transurethral bulking injection. Randomized~     studies between TVT and Bulkamid® and the knowledge about cost-effectiveness and patient~     satisfaction is missing.~      This prospective randomized study compares TVT and Bulkamid®-injections in treatment of SUI.~     Main outcome measures are patient satisfaction, complications and effectiveness of the~     treatment in reducing urinary leakage. Secondary outcome measures are cost-effectiveness,~     pain during and after treatment and changes in Quality of Life and symptoms.~   "
78535|NCT02538978|"~     This is a prospective, double-blinded, randomized, placebo-controlled, multi-center, pivotal~     clinical study in which subjects are evaluated for prevention of major limb amputation in the~     treatment of non-reconstructable Rutherford Category 5 critical limb ischemia (CLI). Subjects~     will be randomized in 3:1 ratio (device treatment: placebo-control).~   "
78536|NCT02538965|"~     To determine the activity of lenalidomide in the treatment of pediatric subjects with~     relapsed/refractory AML (with second or greater relapse or refractory to at least 2 prior~     induction attempts) measured by morphological complete response defined as either a CR or CRi~     within the first 4 cycles of treatment.~   "
78669|NCT02537197|"~     This study examines the effect of regular naltrexone dosing on disordered gamblers. Gamblers~     will also be scanned pre- and post-treatment where we will investigate the functional changes~     to tasks designed to engage brain region associated with gambling and addiction. These~     changes will be correlated with treatment outcomes and urge scores.~   "
78537|NCT02538952|"~     Background: In Botswana, as in the rest of sub-Saharan Africa, undiagnosed TB or TB diagnosed~     late in the course of disease is thought to be the most common cause of death among~     HIV-infected persons.~      Interventions for Evaluation: The Xpert MTB/RIF assay for the GeneXpert platform (Xpert) has~     a TB diagnostic sensitivity of 82.4%, significantly superior to that of smear microscopy~     (44.6%). In line with WHO guidelines, the Botswana Ministry of Health (MOH) and CDC rapidly~     rolled out the Xpert device and a new Xpert-based diagnostic algorithm in service of 22 HIV~     care and treatment clinics. To maximize impact of the Xpert device in improving detection of~     active TB, Xpert rollout was preceded by strengthening of TB screening procedures by: (1)~     adopting the WHO-recommended 4-symptom TB screen for adults; (2) situating trained TB~     case-finding nurses in facilities; and (3) training health facility personnel in TB~     diagnostic algorithms. The combination of these strengthened TB screening procedures and~     rollout of the Xpert device is referred to as the Xpert package in this protocol.~      Key Evaluation Objectives: The protocol has two key objectives: (1) to evaluate whether the~     new MOH-recommended Xpert-based TB diagnostic algorithm for new adult HIV clinic enrollees is~     more sensitive than the pre-Xpert smear-microscopy-based algorithm in diagnosing~     culture-positive TB disease; and (2) to evaluate the impact of the whole Xpert package on~     all-cause mortality during the first 6 months of ART, among adult patients.~      Design: Stepped-wedge cluster randomized trial. Sample Size: 6,136 patients were~     prospectively enrolled to meet the first primary objective. A retrospective cohort of 10,131~     persons was also enrolled to meet the second objective. Projected power to meet both~     objectives is >80%.~      Time line: Prospective cohort enrollment started in July 2012 and was complete by March 2014.~     Retrospective cohort enrollment was complete by March 2015. Patient follow-up and data entry~     will be complete in March 2016 at which time analysis to answer the first two primary study~     questions will be possible.~   "
78538|NCT02538939|"~     Calcific tendinitis of the rotator cuff is a common cause of chronic pain of the shoulder.~     US- guided needling and lavage of the calcification is one of the therapeutic options after~     failure of conservative management with physiotherapy and anti-inflammatory drugs. The goal~     of this procedure is to remove the calcific deposit that is believed to cause the~     sub-acromial impingement. However, studies have shown that complete and rapid disappearance~     of the calcification deposit after irrigation is rare. The treatment is thought to promote~     the spontaneous resorption that occurs the weeks and months after the procedure. However, due~     to this slow process, time to complete recovery can be long. Moreover, it has been shown an~     association between the amount of removed calcium and improved outcome. Therefore, there is a~     need to find a way to remove quickly and completely the calcific deposit after irrigation.~     Sodium thiosulfate has been used successfully in the treatment of calciphylaxis and~     subcutaneous calcification deposit. The mechanism of action involves chelation of calcium~     into calcium thiosulfate salts which are much more soluble than other salts of calcium. Our~     hypothesis is that injection of sodium thiosulfate after irrigation of the calcification will~     help to dissolve the calcific deposit and thus prompt the disappearance of the calcification.~   "
78539|NCT02538926|"~     This phase II trial studies how well etoposide, prednisone, vincristine sulfate,~     cyclophosphamide, and doxorubicin hydrochloride with asparaginase work in treating patients~     with acute lymphoblastic leukemia or lymphoblastic lymphoma. Drugs used in chemotherapy, such~     as etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin~     hydrochloride, work in different ways to stop the growth of cancer cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. Asparaginase~     breaks down the amino acid asparagine and may block the growth of tumor cells that need~     asparagine to grow. Giving combination chemotherapy with asparaginase may work better in~     treating patients with acute lymphoblastic leukemia or lymphoblastic lymphoma.~   "
78540|NCT02538913|"~     Cancer treatments often cause acute toxicity during treatment, and late toxicity after~     treatments have ended. Bowel dysfunctions, incontinence (anal and urinary) and dysfunction~     are late side effects associated with cancer treatment in general, and patients treated for~     pelvic malignancies are at a higher risk. In Norway, the incidence of rectal cancer was 1329~     in 2010. Advances in the treatment during the past few decades have led to fewer local~     recurrences and increased long-term survival, and today the relative survival is 66% for~     women and 64% for men. More patients are having sphincter-preserving surgery with low~     colorectal or ultralow coloanal anastomoses, and low anterior resection (LAR) is done in 70%~     of the patients with curative surgery. Unfortunately, many patients experience altered bowel~     function after LAR. Frequent bowel movements, urgency, evacuatory difficulties and fecal~     incontinence are common and distressing complications. These functional disturbances are seen~     in up to 50-60% of the patients, and most frequent when surgery is combined with neoadjuvant~     therapy. Urinary incontinence and decreased sexual function is also common in both men and~     women following rectal cancer treatment.~      In many surgical settings, patients with higher preoperative physical fitness rehabilitate~     more quickly and have fewer operative complications compared with patients who are less~     physically fit. Additionally, specific strength training of the pelvic floor muscles builds~     up muscle volume, elevates the location of the pelvic floor muscles and pelvic organs, and~     closes the levator hiatus thus providing improved structural support for the pelvic floor as~     well as more optimal automatic function. The aim of the present trial is to investigate~     whether exercise training including pelvic floor muscle training during preoperative~     radiotherapy can reduce symptoms of bowel, urinary and sexual dysfunction and affect the~     physiology of the anal sphincter muscle after LAR. In addition quality of life,~     cardiopulmonary parameters and postoperative complications will be studied.~   "
78541|NCT02538900|"~     This proposed study will determine whether an exercise intervention that avoids continuous~     supervision and exercise-related ischemic pain improves walking performance at 52-week~     follow-up in people with PAD. Our intervention directly addresses two aspects of current~     practice guidelines that are major barriers to exercise for patients with PAD: 1) the~     recommendation for supervised exercise and 2) the recommendation for high intensity~     ischemic-pain inducing walking exercise.~   "
78542|NCT02538887|"~     The purpose of this study is to evaluate the FDA-approved Radio Frequency Surgical Detection~     System (RFDS) as a non-radiological means to ease the process of detecting retained sponges~     and reconciling sponge counts in the labor and delivery room (following vaginal birth).~   "
78543|NCT02538874|"~     The purpose of this study is to assess safety, to measure blood levels of drug, and to find~     out what the drug does to the body.~   "
78551|NCT02538770|"~     Viral respiratory infections are common and often require use of health care resources.~     Patients receive inappropriate bacterial antibiotics, which has many problems including~     side-effects, development of resistance and costs.~      A small portion of the infections leads to severe clinical manifestations including~     hospitalisations and deaths. The significance of influenza virus is well known and it is~     actively detected in all age groups. However, the benefits of detecting other respiratory~     viruses have mainly been studied among children but not among adults. The development of~     multiplex PCR technique has provided a new and sensitive method for diagnosing a large panel~     of viruses. To convince the economical benefits of the rapid viral diagnostic in adult~     infectious patient, more evidence is needed.~      In our randomized study, nasal and pharyngeal samples from the patients evaluated at the~     emergency clinic of internal medicine in the University Hospital of Oulu because of any~     respiratory symptom, chest pain or fever, will be collected. The samples will be tested for~     16 different respiratory viruses by using Anyplex TMII RV16 Detection. The adult participants~     will be randomized in two groups. In one group the results of the testing will be reported~     for the attending physician as soon as possible, and in the other group 7 days after~     sampling. The effect of this delay to patient care is monitored. Also the results of children~     and adults are compared as well as results of men and women. The hypothesis is that rapid~     viral diagnostics shortens the length of admission and diminishes the use of bacterial~     antibiotics. New information on the viral epidemiology among children and adults is provided~     and clinical manifestations of specific viral infections in adults are described.~      The estimated 1500 samples are also tested for 5 different respiratory bacteria by Anyplex TM~     II RB5 Detection. These results will be examined after completion of the study period. The~     benefits of rapid bacterial detection are evaluated in respect to the clinical course of the~     disease and considering the infection control aspects as well.~   "
78544|NCT02538861|"~     This is a prospective open label two arms clinical trial. ARM-A patients will receive the~     standard of care diagnostic test at Baptist Hospital Main (BHM), which includes Single Photon~     Emission Computed Tomography (SPECT) imaging, while ARM-B patients will be randomized~     sequentially into two groups; Group-1 will receive CT Angiography and CT myocardial perfusion~     with new Revolution CT scanner (General Electric Healthcare) while the Group-2 will receive~     SPECT imaging test; both groups of ARM-B at West Kendall Baptist Hospital (WKBH). The primary~     hypothesis is that the combined evaluation of CT angiography with CT myocardial perfusion is~     more efficient in detecting or excluding acute coronary syndrome resulting in early discharge~     and decrease length of stay of patients from the Emergency Department (ED) compared to a~     strategy with SPECT alone. The secondary hypothesis is that a strategy with CTA/CTP can~     reduce direct patient care costs and potentially improve patient outcomes in the same patient~     population when compared to a strategy with SPECT imaging alone.~      The main purpose of this study is to have a definite ED chest pain admission triage, which~     will help to reduce the length of stay and direct patient cost. This approach will reduce the~     economic burden in intermediate risk group patients as well. We had a Baptist statistician~     run the numbers. This study will provide important preliminary data to guide clinical~     implementation of CTP/CTA in clinical practice. We divided arm B into two groups as the CT~     protocol might be different at each hospital, so we want to reduce bias as a result of~     variation in clinical patterns in the different hospitals. Also, we kept 50 patients in arm A~     (Baptist hospital) to have a control group at the hospital level.~   "
78545|NCT02538848|"~     To investigate safety and tolerability of HTD4010 after single ascending doses (SAD) in~     healthy volunteers~   "
78546|NCT02538835|"~     This study evaluates the effect of metacognitive group therapy on depression compared to~     mindfulness groups and supportive groups. The participants, all with a history of depression~     and with current symptoms of depression, will be randomized to one of the three group~     interventions.~   "
78547|NCT02538822|"~     Aneurysms of the thoracic ascending aorta are a serious pathology which may threatens life by~     rupture or dissection. Their incidence is estimated at 10.4 per 100,000 people. At present,~     the only parameter for assessing the risk of complication is the maximum diameter of the~     aneurysm. The only way to avoid a complication is a surgical replacement of the aneurysmal~     aorta by a prosthetic tube. This procedure is performed by sternotomy and with extracorporeal~     circulation and its death rate ranges between 3% and 5%. Surgical repair is indicated when~     the diameter of the aneurysm exceeds 5.5 cm for degenerative atheromatous aneurysms or 5 cm~     in a patient with genetic disorder of connective tissue (Marfan disease or Ehlers-Danlos~     syndrome). However, there are aneurysms with diameter greater than the surgical threshold~     which remain stable. Conversely, complications have been described for aneurysms less than~     4.5 cm in diameter. The criterion of diameter appears therefore as inadequate to assess the~     risk of complication of an aneurysm of the ascending aorta.Multiple methods have been~     described in the literature. One of them relies on in vitro mechanical testing on healthy or~     aneurysmal tissue. Another method is the vivo analysis from imaging (CT, MRI or ultrasound).~     So far, no algorithm is robust enough for predicting the risk of complication better than the~     universally used criterion of diameter.~      The pathophysiology of these aneurysms has also been explored from histological studies. The~     investigators know that the microstructure of the aortic wall of an aneurysm is deteriorated~     with a degradation of elastin fibers and collagen that determine to a large extent its~     biomechanical behavior. Histological analysis appears inseparable from biomechanical~     analysis.~   "
78548|NCT02538809|"~     Bladder cancer is a well-recognized complication in spinal cord injury (SCI) individuals. The~     observed incidence rates in SCI individuals are considerably higher compared to the general~     population. Bladder cancer in SCI individuals tends to present at an earlier age compared to~     the general population. Furthermore, bladder cancer in SCI individuals is more commonly~     invasive and at a more advanced stage at the time of diagnosis compared to bladder cancer in~     the general population. Individuals with bladder cancer commonly present with hematuria and~     other urinary symptoms. The gold standard for diagnosis is cystoscopy. However in SCI~     individuals, hematuria may get attributed to catheter irritation or trauma or an urinary~     tract infection. Furthermore, the bladder wall commonly presents with various changes under~     cystoscopic examination masking the presence of a bladder wall mass. Thus, diagnosis of~     bladder cancer in SCI individuals can be complicate.~      There is a novel test available (GeneXpert® Bladder Cancer Detection, Cepheid International,~     Sunnyvale, CA, USA) for the measurement of mRNA bladder tumor markers in the urine. The~     diagnostic accuracy of this test has been investigated in non-SCI individuals with symptoms~     suspicious for bladder cancer. The test showed high sensitivity and specificity values and is~     thus a promising diagnostic or screening tool.. However, the diagnostic accuracy of the test~     has not yet been investigated in SCI individuals.~      The primary objective of the proposed study is to investigate whether urine mRNA tumor marker~     levels in spinal cord injury individuals with symptoms and findings suspicious for bladder~     cancer are a discriminator between individuals suffering from bladder cancer and those not~     suffering from cancer.~      Individuals presenting with symptoms suspicious of bladder cancer will undergo ultrasonic and~     cystoscopic examination of the bladder. An urine sample will be taken, and the bladder will~     be flushed for collecting a bladder fluid sample. In patients with bladder wall findings~     suspicious of cancer, a bladder wall biopsy will be taken, according to clinical standard~     practice. The bladder fluid and the bladder wall biopsy will be submitted for cytology and~     histopathology examination, respectively. Tumor mRNA levels will be measured in the urine~     sample.~   "
78549|NCT02538796|"~     Anorexia nervosa (AN) is a common psychiatric illness, with severe prognosis (5% mortality)~     that has changed little over in half a century. One of the forms is the restrictive anorexia~     nervosa (ANR). It consists of a phobia of weight gain and food with a massive food~     restriction. This pathology is studied in psychology but not using the theories of embodied~     cognition in which perception and action interact through sensorimotor processes. They are~     the source of attitudes (unconscious) towards certain stimuli and influence our~     interpretation (conscious).~   "
78550|NCT02538783|"~     This study aims to evaluate the effectiveness of financial incentives in improving and~     maintaining weight loss.~   "
78552|NCT02538744|"~     The investigators will assess the impact of treatment with doxazosin and modafinil, alone and~     in combination, on the subjective and reinforcing effects of cocaine in~     non-treatment-seeking, cocaine-dependent volunteers. The investigators will use a hybrid~     design in which participants will be randomized into two groups: placebo and doxazosin 8~     mg/d. They will remain in their assigned group for the duration of the study. After titrating~     doxazosin to the target dose, study procedures will be completed three times, once during~     treatment with each dose of modafinil (0, 200, and 300 mg/d), in pseudo-random order such~     that 200 mg precedes 300 mg).~   "
78642|NCT02537548|"~     This phase II trial studies how well retroperitoneal lymph node dissection (RPLND) works in~     treating patients with stage I-IIa testicular seminoma. The retroperitoneum is the space in~     the body behind the intestines that is typically the first place that seminoma spreads. RPLND~     is a surgery that removes lymph nodes in this area to treat testicular seminoma and may~     experience fewer long-term toxicities, such as a second cancer, cardiovascular disease,~     metabolic syndrome (pre-diabetes), or lung disease.~   "
78553|NCT02538731|"~     Very large bile duct stones are difficult to remove. Dilation-assisted stone extraction, also~     termed small endoscopic sphincterotomy plus endoscopic papillary large balloon dilatation, is~     safe and effective technique for the treatment of large CBD stones. However, in approximately~     5-10% of patients, the removal of large bile duct stones may be difficult. For this selected~     group of patients for whom all conventional endoscopic stone treatment devices have failed,~     laser lithotripsy technology has provided an approach to the fragmentation of difficult bile~     duct stones.~      A single-operator cholangioscopy (SOC) system (SpyGlass Direct Visualization System, Boston~     Scientific Corp., Natick, MA, USA) has overcome most of the conventional cholangioscopy~     limitations. The investigators aimed to evaluate the efficacy and safety of Spyglass-guided~     laser lithotripsy for difficult CBD stones not amenable to conventional dilation-assisted~     stone extraction therapy.~   "
78554|NCT02538718|"~     Ritodrine is the conventional and the only approved tocolytics in Korea(by KFDA), although it~     was withdrawn from the US market more than 10 years ago. As already known well, ritodrine has~     many side effects such as tachycardia, hyperglycemia, pulmonary edema and so on. When such~     complications of ritodrine appears, clinicians consider of using MgSO4 as substitute, but its~     use is off-the-label yet in Korea. Facing this discrepancy, the investigators want to compare~     the efficacy and safety of MgSO4 with ritodrine and prove that MgSO4 is not inferior to~     ritodrine as tocolytics. For the singleton and twin pregnancies between 24+0weeks and 34~     completed weeks whose uterine contraction is more than 4 during 20 minutes period with their~     cervical ripening is more than 25%, the investigators randomise them in Ritodrine group or~     MgSO4 group. Then, the investigators will check the change of their interval of uterine~     contraction, degree of pain and the appearance of any side effects or treatment failure sign.~   "
78555|NCT02538705|"~     The purpose of this study is to determine whether pl-vegf165 (Neovasculgen) is effective in~     the treatment of ulcers related to diabetic foot syndrome~   "
78556|NCT02538692|"~     The purpose of this study is to test the efficacy and safety of a traditional Chinese~     medication Tong-Xie-Yao-Fang for patients with diarrhea-predominant irritable bowel Syndrome~     (IBS-D).~   "
78557|NCT02538679|"~     Postoperative pain can pose significant challenges in the postoperative recovery of patients~     undergoing major colorectal surgery. Traditionally, opioids have played an important role in~     treating postoperative pain. It is well established that opioids are highly effective in~     relieving pain; however opioids are associated with numerous side effects that include~     nausea, vomiting, constipation, ileus, bladder dysfunction, respiratory depression, pruritus,~     drowsiness, sedation, and allergic reaction. These opioid side effects, which range in~     severity, can significantly interfere with discharge home following colorectal surgery.~     Significant interest exists in the use of local anesthetic based regional anesthesia~     techniques as a means to extend the analgesic window for patients undergoing colorectal~     surgery. Specifically, the use of the transversus abdominis plane (TAP) block as an adjunct~     in postoperative pain control has been widely reported in the anesthesia and colorectal~     surgery literature. Historically, the block was performed in a blind fashion with relative~     success and presently the block is typically performed either with ultrasound guidance or~     laparoscopic visualization. While TAP block has shown to be effective in post-operative pain~     control, the techniques used to place the block have not formally been compared.~      The investigators are purposing a prospective, patient-blinded, randomized study of patients~     undergoing major colorectal surgery to compare TAP block under ultrasound guidance versus~     laparoscopic visualization versus no TAP block. The investigators hypothesize that~     laparoscopic-guided TAP block is non-inferior to ultrasound-guided TAP block with respect to~     perioperative pain control and either technique is superior to no TAP. In addition the~     investigators will measure procedural time, any adverse events related to the block, overall~     postoperative analgesic requirement, analgesic duration, postoperative pain scores, length of~     postoperative hospital stay, incidence of postoperative ileus, and overall patient~     satisfaction between the three groups.~   "
78558|NCT02538666|"~     In this study, all patients must have already completed first-line chemotherapy to treat~     extensive-stage disease small cell lung cancer. The purpose of this study is to show that~     Nivolumab, or Nivolumab plus Ipilimumab followed by Nivolumab by itself, will prolong overall~     survival and progression free survival when administered as consolidation treatment in~     patients that are stable or responding after chemotherapy. Patients receiving treatment will~     be compared with patients taking placebo.~   "
78559|NCT02538653|"~     This study aimed at determining the 4-hours postprandial blood glucose and insulin responses~     to the ingestion of cereal product differing by their SDS content.~   "
78560|NCT02538640|"~     This is a laboratory-based research study conducted in two parts. Open cross-over design. 2~     test sessions per subject included in the study. It aims at determining the postprandial~     blood glucose and insulin responses to the ingestion of cereal product differing by their SDS~     content and GI in 20 healthy non-smoking voluntary subjects, aged from 18 to 45 years.~   "
78561|NCT02538627|"~     This is a Phase 1 open-label, dose-escalation trial using 3+3 design, evaluating MM-151~     co-administration with MM-121, MM-141, and trametinib at varying dose levels.~   "
78562|NCT02538614|"~     This study consists of 2 parts: Phase 1b and Phase 2. Phase 1b will evaluate the safety and~     tolerability of the combination of idelallisib with the anti-CD37 monoclonal antibody BI~     836826 in participants with relapsed/refractory chronic lymphocytic leukemia (R/R CLL), and~     establish the maximum recommended Phase 2 combination dose (highRP2D) as well as an alternate~     lower recommended Phase 2 combination dose (lowRP2D). Phase 2 will determine the rates of~     complete response (CR) and of minimal residual disease (MRD) negativity with the combination~     at the highRP2D and the lowRP2D in participants with R/R CLL.~      The Phase 2 portion of this study will not occur.~   "
78563|NCT02538601|"~     The purpose of this study was to test the efficacy of a CBT-based smoking cessation treatment~     enhanced with transdiagnostic skills for the management of anxiety and fear-based avoidance~     behaviors (CBT-A) relative to a standard CBT-based smoking cessation treatment (CBT-S) for~     smokers with elevated PTSD symptoms who were exposed to the 9/11 World Trade Center disaster.~     The investigators hypothesized that the CBT-A treatment would yield more favorable outcomes~     with regard to smoking abstinence as well as improvements in PTSD and respiratory symptoms~     over a 6-month follow-up period.~   "
78564|NCT02538588|"~     Comparison between two modalities of nebulization.~   "
78565|NCT02538575|"~     The purpose of this study is to determine whether the 6-minute walk test (6MWT) could be a~     prognostic factor for cystic fibrosis patients.~   "
78566|NCT02538562|"~     This study is designed to gather epidemiological data in Korea on HER2 incidence in gastric~     and gastroesophageal junction cancer as assessed by local laboratories in a real-life~     setting. No investigational products will be provided or evaluated.~   "
78603|NCT02538068|"~     This study plans to learn more about psychosocial factors that contribute to adopting~     physical activity. The goal of this study is to improve upon existing theories of behavior~     change in order to help other people become more physically active.~   "
78567|NCT02538549|"~     Behavioral activation (BA) is a low cost, evidence-based intervention that can be effective~     in treating depression and anxiety. We have developed a behavioural activation card game for~     clients receiving treatment through the Crisis Team and Traditional Case Management (TCM) in~     Kingston, ON. The game is designed to integrate behavioural activation tools into daily life~     while receiving points for completion of the each Activity Challenge, which are divided into~     4 areas (ACE4), with the goal to receive maximum amount of points in the timeframe of the~     study. Using a Randomized Control Trial (RCT) design, participants (n=40) will be assigned to~     one of two groups, with the intervention group receiving ACE4 and treatment as usual (TAU)~     and the control group only receiving TAU. Assessments will be carried out upon entry to the~     study and at the end of the intervention period (8 weeks). Assessments will be completed~     using the WHODAS 2.0 (World Health Organization Disability Assessment Schedule), HADS (The~     Hospital Anxiety and Depression Scale), and CORE (Clinical Outcome in Routine Evaluation). We~     hypothesize that the treatment group receiving the ACE4 intervention will show improvement in~     overall mental state. Analyses will be conducted using SPSSv16, an analysis of covariance and~     t-test, and a binary logistic regression analysis will be used to investigate factors that~     predict good outcomes. Results will be published in international journals and presented at~     conferences with an aim towards being applied to clinics in Pakistan.~   "
78568|NCT02538536|"~     This is a Phase 2, open-label, single-arm study of the safety and tolerability of PBI-4050~     800 mg daily oral administration in 40 adult patients with IPF.~   "
78569|NCT02538510|"~     This phase I/II trial studies the side effects of pembrolizumab and vorinostat in treating~     patients with squamous cell head and neck cancer or salivary gland cancer that has come back,~     has spread to other places in the body and/or cannot be removed by surgery. Monoclonal~     antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and~     spread. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Giving pembrolizumab together with vorinostat may be a better treatment for~     head and neck cancer or salivary gland cancer.~   "
78570|NCT02538497|"~     Postpartum depression (PPD) is a prevalent disorder. Studying the factors related to PPD will~     help to identify families at risk and provide preventive interventions. This can in turn~     improve the developmental trajectories for the children. Several previous studies have~     investigated risk factors for PPD. However, few studies have focused on cognitive~     vulnerability factors. The first aim of the present study is to explore a range of protective~     and risk factors, including cognitive factors, for PPD, parent-infant interactions and child~     development. The second aim of the study is to evaluate the effectiveness of The Newborn~     Behavioral Observation (NBO) as a universal preventive intervention delivered in routine~     practice. The NBO is a brief relationship-enhancing intervention that may reduce depressive~     symptomatology in mothers.~   "
78571|NCT02538484|"~     Assess the impact of dietary omega 3 free fatty acids and/or letrozole on obese,~     postmenopausal breast cancer patients.~   "
78572|NCT02538471|"~     Patients with metastatic breast cancer receiving at least one single agent chemotherapy and~     demonstrating stable disease or disease progression at two consecutive clinical/radiological~     assessments (at an interval of at least 2 weeks).~      Transforming growth factor-beta (TGFΒ) blockade will enhance response of irradiated tumors~     and improve the function of Dendritic and T cells. Patients will receive 300 mg/day of study~     drug administered via oral drug tablet every day for 14 days on and 14 days off (=28 day~     cycle). Radiation to a metastatic site will be delivered at a dose of 7.5 Gy, given~     consecutively on days 1-3-5.~   "
78573|NCT02538458|"~     Efficacy/Safety of 3% hypertonic saline inhalation (24H vs 72H) to treat acute bronchiolitis~     in infants.~   "
78574|NCT02538445|"~     Based on the theory of embodied cognition, which focuses on the influence of sensory and~     motor processes on cognition, researchers propose to study the influence of the action on~     memorization and inhibition in patients suffering from schizophrenia, using a directed~     forgetting paradigm. The directed forgetting paradigm is used, composed of two lists of~     action verbs. The instruction to forget is given at the end of learning the first list (To~     Be Forgotten (TBF)), following a simulation of a computer bug. Therefore a second list is~     presented to be learned and remembered (To Be Remembered (TBR)). A recognition task is~     performed at the end. The action verbs had to be encoded using four conditions: action~     performed, mimed, imagined action, action with a contextual word, reading the action verb~     only. 48 schizophrenic patients were included in this study. Patients were randomized to have~     10 participants per condition. 48 controls matched by age, gender, laterality and education~     are also included and randomized in the same modality. This study aims to show that the~     encoding of sensory-motor components, more than providing a context could improve the~     inhibitory capacities but also memory in schizophrenia, and possibly be used in remediation~     cognitive.~   "
78575|NCT02538432|"~     This is a phase II trial of (RQ-07) in advanced solid tumors in prostate, breast or non-small~     cell lung cancer.~   "
78576|NCT02538419|"~     The investigators will compare two alternatives designed to maximize adherence to continuous~     positive airway pressure (CPAP) therapy for obstructive sleep apnea (OSA) - peer-support~     administered in groups, versus individual education.~   "
78577|NCT02538406|"~     Colonoscopy( examining the colon with a flexible tube and a camera ) is usually done for~     screening purposes to find any precancerous lesions (polyps) at an early stage. During the~     colonoscopy the doctor will advance the colonoscope to the end of your colon and start~     examining the colon for any polyps. Withdrawal time is the period of time the doctor spends~     examining the colon. Doctors usually spend six minutes examining the colon after they reach~     the end of the colon. Studies have showed that spending more withdrawal time detects more~     lesions. The proposal to dedicating half of the withdrawal time during colonoscopy in~     examining the right side will increase the detection of polyps in the right side of the~     colon. There will be no other changes in the procedural aspect of the colonoscopy.~   "
78604|NCT02538055|"~     As many as 75% of people with diabetes report chronic pain. While cognitive behavioral~     therapy (CBT) improves pain and functioning in individuals with chronic pain, many rural and~     underserved communities lack resources for such programs. The investigators tested the~     hypothesis that a CBT-based program delivered by community health workers (CHW) can improve~     quality of life in individuals with diabetes and chronic pain.~   "
78578|NCT02538393|"~     The primary objective of the study is to~      • Investigate the relative bioavailability of sorafenib as 400 mg (4 x 100 mg) tablet for~     oral suspension formulation in comparison to 400 mg (2 x 200 mg) marketed tablet formulation.~      The secondary objectives of this study are to~        -  Evaluate the dose proportionality in sorafenib pharmacokinetics for sorafenib tablet for~          oral suspension formulation after administration of 200 mg (2 x 100 mg) and 400 mg (4 x~          100 mg) dose of sorafenib in fasted state~        -  Evaluate the effect of food on the pharmacokinetics of the tablet for oral suspension~          formulation after administration of a single dose of 400 mg sorafenib (4 x 100mg)~        -  Evaluate the taste and palatability of sorafenib (both formulations)~        -  Assess the safety and tolerability of sorafenib tablet for oral suspension in healthy~          male subjects~   "
78579|NCT02538380|"~     The purpose of this study is to compare EUS-B-FNA (using the EBUS scope)with EUS-FNA for left~     adrenal gland analysis in lung cancer patients.~   "
78580|NCT02538367|"~     A randomized, double-blind/open-label, placebo/active-controlled, single/multiple dose,~     parallel, phase 1/2a trial to evaluate the safety, tolerability, pharmacokinetics and~     pharmacodynamics of YH12852 in healthy subjects and patients with functional constipation~   "
78581|NCT02538354|"~     This study will evaluate if suppelementation of the diet with riboflavin in Crohn's disease~     patients will result in an increase in the amount of F. prausnitzii.~   "
78582|NCT02538341|"~     The VaricElla zosteR VaccinE (VERVE) trial evaluates the safety and effectiveness of the~     herpes zoster (shingles) vaccine, Zostavax, in patients over 50 years old with arthritis and~     other diseases who are using anti-TNF therapy and who have not previously received the~     vaccine.~   "
78583|NCT02538328|"~     Comparison of harmonic scalpel and ligasure devices in laparoscopic morbid obesity surgery~     especially in gastric bypass surgery patients.~   "
78584|NCT02538315|"~     While positron emission tomography/computed tomography (PET/CT) can assist in the diagnosis~     of Parkinson disease (PD), it can also potentially help monitor treatment options for PD. One~     such experimental therapeutic option for PD is fetal dopaminergic transplantation trials. A~     potential goal of such novel therapies is to replace deficient dopaminergic neurons in PD.~     Researchers at the University of Saskatchewan have been at the frontier of these exciting~     treatment options. [18F]FDOPA PET/CT imaging has been successfully used by some authors to~     monitor engraftment and assess efficacy of fetal dopaminergic transplant . This study also~     aims to utilize [18F]FDOPA PET/CT imaging to potentially aid in detecting alterations in the~     dopaminergic pathway from these innovative surgical treatment options.~      There are two main objectives of this study: 1) Evaluate the effectiveness of fetal~     dopaminergic grafts in patients with PD using FDOPA PET imaging pre and post-surgical~     implantation and a secondary longer term goal 2) Correlate the [18F]FDOPA PET/CT findings in~     early PD with post-mortem pathological analyses of PD~   "
78585|NCT02538302|"~     Nocturnal enuresis is among the most common disorders in children. The aim of current study~     was to compare the efficacy and safety of Minirin and oxybutynin for treatment of nocturnal~     enuresis in children in Bandar Abbas in 2014.~   "
78586|NCT02538289|"~     Dyspnea is a symptom that is growing in incidence, as respiratory and heart diseases are~     becoming more frequent. Patients suffering from dyspnea have a significant disabling due to~     chronic refractory dyspnea and crisis of irruptive dyspnea. Although there are several tools~     that may produce an improvement of symptom intensity, they are underused.~   "
78587|NCT02538276|"~     Cerebrovascular disease is a leading cause of death and the leading cause of serious~     long-term disability. Carotid artery stenting (CAS) and carotid endarterectomy (CEA) are~     alternative strategies for stroke prevention in patients with atherosclerotic carotid~     disease.The safety and efficacy of CAS compared to CEA still remains questioned, and CEA has~     been considered to the first-line treatment of carotid stenosis in worldwide. The purpose of~     this study is to compare the practice and outcomes of CAS and CEA in a real world setting at~     Public University Hospitals in Brazil.~   "
78588|NCT02538263|"~     Volume-targeted noninvasive ventilation (VT-NIV), a hybrid mode that targets a preseted tidal~     volume (VT) by automated adjustment of pressure support, could guarantee the delivered VT~     over pressure-limited noninvasive ventilation (PL-NIV) with fixed level pressure support.~     Whether VT-NIV is more effective in improving gas exchange in patients with acute hypercapnic~     respiratory failure (AHRF) as compared with PL-NIV remains unclear. Our aim was to verify~     whether in comparison with PL-NIV, use of VT-NIV was more effective in correcting~     hypercapnia, hence reducing the need for intubation and improving survival in patients with~     AHRF.~   "
78589|NCT02538250|"~     Required for Advisory Committee for Borderline Substances (ACBS) approval. Aim of this study~     is to access the palatability, compliance and GI-tolerance of Nutricomp® Drink Plus to show~     that it is acceptable for patients in the United Kingdom.~   "
78590|NCT02538237|"~     Aim: Use an ibuprofen mouthwash 2% irrigate subgingival in improving the progression of~     periodontal diseases can be evaluated. Materials and Methods: 22 patients with chronic~     periodontitis without any systemic disease who have had periodontal disease, and 2 molars~     that have periodontal pockets deeper than 4 mm on either side of the lower jaw have the~     clinical examinations. Interventions: For patients who participated in this study, subjects~     who received oral hygiene instruction and scaling root planing (SRP), After 2 weeks, They~     were divided into two groups as determined by randomization in this study, Experimental~     group: ibuprofen 2% mouthwash (made from the Faculty of Pharmaceutical Sciences, Islamic Azad~     University, Tehran), Control group: placebo, Subgingival Irrigation of ibuprofen 2% mouthwash~     with an insulin syringe 0.5 ml were rinsed, Clinical measurements including probing depth~     (PD), clinical attachment levels (CAL), Plaque Index (PI), and Bleeding Index (BI) were~     recorded and the patients were recalled per once every 2 weeks for 3 months is repetitive,~     and at the end of 3 months, were evaluated changes in clinical periodontal parameters. ®~   "
78616|NCT02537899|"~     SATURN investigates the promising role of NeuroAiD in patients with spinal cord injury and~     will provide important information on the feasibility of conducting larger controlled trials.~   "
78643|NCT02537535|"~     Cross-sectional observational study designed to identify and describe the care gap in~     guideline-oriented low density lipoprotein cholesterol (LDL-C) management in Canadian~     patients at high cardiovascular risk.~   "
78644|NCT02537522|"~     The objective of this study is to determine if corneal diameter and keratometry readings~     correlate to subjective comfort and lens fitting characteristics.~   "
78591|NCT02538224|"~     Objectives: The aim of the present clinical study was to evaluate the efficacy of doxycyline~     3% plus ketoprofen 2.5% as an adjunct to scaling and root planing in the treatment of chronic~     periodontitis(early-modearte). Material and Methods: 20 systemically healthy, chronic~     periodontitis patients were included in the study.The Patients were selected on the basis of~     having chronic periodontitis with periodontal pocket depths of more than 4mm on at least two~     teeth in mandibular molar area; Periodontal parameters (plaque, bleeding on probing and~     pocket depth) were recorded at baseline and every 15 days for 3 months. Oral hygiene~     instructions were given that included brushing twice- daily, (Using the Bass brushing~     technique for at least 2 minutes ), Randomly divided two groups,Test group: was treated by~     scaling and root planing Followed by local delivery of doxycycline 3%+ ketoprofen 2.5%, While~     the control group: was treated by scaling and root planing along with ketoprofen 2.5%; and~     was administered to the both groups every 15 days for 3 months, repeated. Every 15 days once~     periodontal parameters were assessed, and at the end of 3 months, evaluated the clinical~     parameters changes.~   "
78592|NCT02538211|"~     The purpose of this study is to evaluate if the intestinal microbiota influences rotavirus~     vaccine immune responses in healthy adult volunteers.~   "
78593|NCT02538198|"~     This is a Phase 2 study to assess the good and bad effects of maintenance therapy on patients~     who have been treated for myeloma and no longer show signs of this type of cancer.~   "
78594|NCT02538185|"~     The study is planned as a single-center, randomized, double-blind placebo-controlled,~     comparative Phase I, first-in-man study to assess the safety and tolerability of the~     NanoJect™ device, and the immunogenicity of the rabies vaccine Vaccin rabique Pasteur®~     delivered with the NanoJect™ device by ID route.~   "
78595|NCT02538172|"~     An open-label randomized controlled trial to adapt the duration of antiviral prophylaxis in~     D+/R- patients and in R+ patients receiving ATG according to the result of the T-Track® CMV~     assay. Investigators will include kidney and liver transplant recipients. Patients will be~     randomized during the first month post transplant.~      In the interventional arm, while the patient is on antiviral prophylaxis, CMI will be~     monitored every 4 weeks from the 2nd month after transplant. Measurement of CMV CMI will be~     done in real time by using the T-Track® CMV assay. The continuation of antiviral prophylaxis~     will depend on the result of the assay:~        -  T-Track positive (patient at lower risk): discontinuation of the antiviral drug~        -  T-Track negative (patient at higher risk): continuation of the antiviral drug until the~          maximal duration of prophylaxis (3 to 6 months) The standard arm will receive a standard~          fixed duration of antiviral prophylaxis (3 months for R+ thymoglobulin treated-patients~          and 6 months for D+/R- patients). Measurement of CMV CMI by both T-Track® CMV and the~          Quantiferon-CMV® assays will be done at the same time points of the interventional arm,~          but the result will not be known by the investigators.~      After discontinuation of prophylaxis, patients in both arms will be followed for the~     development of CMV replication at each visit using the local PCR assay and antiviral therapy~     will be administered in case of CMV infection according to local guidelines.~      The co-primary endpoints will be the incidence of CMV disease or antiviral-treated CMV~     replication during the first 12 months post transplant AND the duration of antiviral~     prophylaxis.~   "
78596|NCT02538159|"~     Clinical, prospective, single-center, national trial. open and randomized at 1: 1 to compare~     the rate of bacteremia associated between non-tunneled Central venous catheter and peripheral~     inserted central catheter.~   "
78597|NCT02538146|"~     An open label pilot study will determine the effect of the amino acid nutritional supplement~     acetyl-L-carnitine (ALC) on pain, quality of life, well-being, and serum pro-inflammatory~     mediator and oxidative stress levels in volunteers with chronic pancreatitis. The ALC is~     given to all participants for 3 months, and assessments will occur at intake and after 3~     months.~   "
78598|NCT02538133|"~     Vascular Prothesis Infection is a rare but an extremely serious complication. Diagnosis is~     often difficult (germs are found only in 50% of cases). Conventional imagery is often~     non-specific and difficult to interpret especially in early postoperative phase. Leukocytes~     isolated from the patient's blood are labeled with a radiopharmaceutical technetium~     99mTc-HMPAO.~      The aim of this study is to assess the overall diagnostic performance of scintigraphy (hybrid~     SPEC-CT) with labeled leucocytes in diagnosis of subdiaphragmatic vascular prothesis~     infection.~   "
78599|NCT02538120|"~     This study aims to see whether or not the diabetes 1 patients have a neurovascular~     microcirculatory dysfunction using various microvascular tests which have been previously~     validated.~      Microvascular responses will be assessed by Laser Speckle Contrast Imaging and expressed in~     Laser Speckle Perfusion Units (LSPU).~   "
78600|NCT02538107|"~     This observational study will investigate efficacy and safety of methoxy~     polyethyleneglycol-epoetin beta in participants with a kidney transplant. Data of each~     participant will be collected over 15 months of Mircera therapy.~   "
78601|NCT02538094|"~     This research is being done to determine whether transcranial direct current stimulation~     (tDCS) can improve certain mental abilities in individuals with multiple sclerosis or~     encephalitis. Participants will be asked to come in daily for two full weeks during which~     time they will undergo cognitive testing and Magnetic Resonance Imaging (MRI) brain scans. In~     this research, a very weak electrical current is administered to the surface of the scalp~     while participants complete cognitive tasks. The investigators' aim is to find out whether~     tDCS will improve task performance in adults with multiple sclerosis or encephalitis.~   "
78602|NCT02538081|"~     This study proposes to conduct a clinical trial comparison of olanzapine and the combination~     of a nicotinic cholinergic agonist, 3-[2,4-Dimethoxybenzylidene]anabaseine (DMXB-A) with a~     dopamine D2 receptor antagonist, the mechanism common to all antipsychotic drugs, to test the~     hypothesis that 7-nicotinic receptor agonism may be an additional necessary factor that~     enhances the efficacy of olanzapine that allows its slight superiority to risperidone. This~     trial would enroll patients taking olanzapine and record baseline measurements of clinical~     symptoms, cognition, metabolic parameters, and extrapyramidal side effects. The subjects~     would then be randomized to receive either risperidone or risperidone plus DMXB-A for 6 weeks~     and then would again have measurements of clinical symptoms, cognition, metabolic parameters~     and extrapyramidal side effects.~   "
78645|NCT02537509|"~     Spaced phototherapy sessions during winter as add-on therapy in combination with vitamin D~     supplementation or not, could be beneficial to improve disease LTC in AD patients~   "
78605|NCT02538042|"~     The central objective of the project is to evaluate the effect of incorporating smoking~     related contexts into very low nicotine content (VLNC) cigarette extinction trials on~     clinically relevant, smoking-related outcomes. Adult smokers interested in quitting smoking~     (N=80) will be interviewed and trained to take pictures where they smoke cigarettes.~     Following taking these pictures, participants will then be switched to smoke VLNCs while~     wearing a 21 mg/d nicotine patch (EXT) for three weeks. During this 3-week treatment period,~     half of the sample (n=40) will be randomly assigned to undergo six, 60-minute sessions of~     multiple context extinction (MCE+) during which they will view smoking-related environments~     and smoke their assigned cigarettes. The remaining 40 participants will undergo control MCE~     (exposure to nature environments; MCE-) and smoke their assigned cigarettes. At the end of~     the three weeks, participants will quit smoking and continue to wear the nicotine patch while~     being followed during a 10-week abstinence period. Participants will also complete a~     follow-up phone call 6 months after their quit day.~   "
78606|NCT02538029|"~     The primary aim of the proposed project is to characterize dual tasking (DT) deficits to~     improve motor, cognitive, and quality of life outcomes in individuals with Parkinson's~     disease (PD). Phase 1 of the intervention will involve an in-depth gait analysis on 15~     individuals with PD. This gait analysis will utilize the Computer Assisted Rehabilitation~     Environment (CAREN) system, a virtual reality system with a fully integrated 3-D motion~     capture system. The purpose of Phase 1 is to generalize characteristics of gait and postural~     control during specific DT conditions. Phase 2 (N=20) involves the clinical translation of~     these findings. This phase will involve creating a clinical intervention based on the~     objective information gathered the CAREN system. The intervention will take place 3x/week for~     a total of 8 weeks. Interventional groups will include: 1) DT clinical group (N=10) and 2)~     Single task group (N=10). Outcome measures will be used at the beginning and end of the~     intervention to assess the feasibility and efficacy of the intervention.~   "
78607|NCT02538016|"~     The goal of this research project is to establish that in short-term use, tolvaptan is a safe~     and potentially effective new therapy for cystinuria, by conducting a short-term pilot study~     of the safety and tolerability of this drug, and assess impact on urinary stone risk~     parameters, among adolescent and young adult patients with clinical cystinuria.~   "
78608|NCT02538003|"~     The purpose of this study is to assess safety, tolerability of LCB01-0371 after~     fasting/non-fasting food taken in healthy male subjects.~   "
78609|NCT02537990|"~     The purposes of this study are: 1. To identify and quantify the health utilities and quality~     of life experienced by patients who have been diagnosed with MDS and what are their~     predictors. 2. Measure the effects of patient related factors like frailty and comorbidity on~     quality of life and overall survival or toxicity to therapy. 3. Assess how quality of life~     changes over time and what are its predictors. This will be valuable information that may~     guide therapy, transfusion practices, etc., as MDS is a chronic, incurable disease that is~     often progressive.~   "
78610|NCT02537977|"~     Relapsed/refractory leukemia and lymphoma lack effective treatment. The cancer immunotherapy~     with chimeric antigen receptor (CAR) T cells provides a potent new approach for them. In this~     clinical trial, the investigators aim to assess the safety and efficacy of administering T~     cell expressing an anti-CD19 CARs to patients with chemotherapy resistant or refractory CD19~     positive B cell malignancy including leukemia and lymphoma.~   "
78611|NCT02537964|"~     This is a prospective, controlled; crossover study of daily bathing with no-rinse, 2%~     chlorhexidine gluconate (CHG) impregnated washcloths versus bathing with water/soap or water~     according to gestational age and weight (e.g. standard bathing). The trial will take place in~     the Neonatal intensive care unit (NICU).~      Baseline data ragarding bloodstream infections (BSI) and colonization with multidrug~     resistant orgnisms (MDRO) will be collected for 3-6 months prior to patient enrollment. In~     the preliminary phase of the study we will establish the safety of chlorhexidine bathing~     using Clinell ® Chlorhexidine wash cloths on three groups of patients: term infants admitted~     to the NICU; late preterm infants (34-37 weeks); preterm infants 30-34 weeks of gestation.~     Interim analysis for adverse events will be performed after each group of patients.~      In the subsequent phases of the study, all infants admitted to the NICU and enrolled in the~     study will be bathed three times a week with Chlorhexidine wash cloths during the initial~     6-months study period (intervention), followed by standard bathing during the second 6-months~     period, then again intervention period for 6 months and standard bathing for 6-months. Total~     study period- 3 years.~      Data collection will include all bloodstream infections as well as surveillance cultures~   "
78612|NCT02537951|"~     Small fiber neuropathy (SFN) is a common disorder, which has a profound negative impact on~     quality of life because of severe neuropathic pain. To reliably establish a diagnosis of SFN~     is challenging, since neurological examination and nerve conduction studies are often normal.~     Autofluorescent flavoprotein imaging (AFI) is an optical method through which neuronal~     activity in the termination area of small nerve fibers in the spinal cord can be quantified.~     Since the epidermis also contains a high density of small nerve terminals and since the~     number of intraepidermal nerve fibers is greatly reduced in patients with SFN, our hypothesis~     is that AFI intensity is reduced in patients with SFN. To support this hypothesis, a pilot~     study is required in which the investigators first need to confirm the precision of AFI in~     the epidermis of the third finger of 10 healthy volunteers. Secondly, lidocaine/prilocaine~     cream will be used as a negative control. Finally, the AFI signal will be measured after~     application of a 8% capsaicin patch, through which (temporarily) a selective reduction of~     small nerve fibers can be induced, mimicking SFN. Using this experimental design, the~     investigators will be able to test the reliability and validity of AFI for capsaicin-induced~     small nerve fiber degeneration. This would be a significant step in developing an objective,~     rapid and non-invasive diagnostic tool to diagnose patients with SFN, which may also be~     utilized as a biomarker in studies that assess the efficacy of novel treatments for SFN.~   "
78613|NCT02537938|"~     This study involves the use of an investigational drug called NGP 555. In each group of~     healthy subjects, 2 people will receive placebo and 6 people will receive NGP 555.~   "
78614|NCT02537925|"~     The purpose of this study is to determine whether celecoxib is effective in the treatment of~     nasopharyngeal carcinoma by concurrent chemoradiation with weekly nedaplatin.~   "
78615|NCT02537912|"~     The regulatory effects of the peanut skin extract (Sugarlock®) on body fat and blood glucose~     was demonstrated in a double-blind, placebo-controlled study. .~   "
78618|NCT02537873|"~     The overall goal of this project is to develop initial human data on effects of novel~     compounds on safety (interactions with cocaine) and efficacy (subjective response to cocaine~     and self administration data) in non-treatment seeking cocaine use disorder subjects. The~     compound to be studied will be the 5-HT2CR agonist lorcaserin. Lorcaserin and other 5-HT2CR~     agonists have been shown to reduce cocaine self-administration and cue reactivity in rodents.~     In addition there is human safety data in non-cocaine using subjects for lorcaserin as it is~     currently FDA approved for obesity, and safety data from a cocaine interaction study in~     rodents , but there is no human cocaine interaction/PK data and no PD data to support~     potential dosages for phase II clinical trials.~   "
78619|NCT02537860|"~     This prospective double-blinded clinical trial is intended to compare three nerve stimulator-~     guided paravertebral block injections versus five injections for elderly patients undergoing~     hernia repair regarding intraoperative hemodynamic stability and postoperative pain.~   "
78620|NCT02537847|"~     The aim of the investigators' study was to evaluate oral and non carbapenem antimicrobial~     agents which can be used in outpatient for the treatment of non-bacteremic acute~     pyelonephritis caused by Extended Spectrum Beta Lactamase Escherichia coli. This study was~     conducted to compare the clinical and bacteriological outcomes of patients with~     non-bacteremic acute pyelonephritis caused by Extended Spectrum Beta Lactamase Escherichia~     coli who were treated with intravenous (IV) carbapenems followed by oral sitafloxacin or IV~     ertapenem.~   "
78621|NCT02537834|"~     An open-label, multicenter study to evaluate 52-week long-term safety, tolerability and~     efficacy of Tofogliflozin with GLP-1 analogue treatment in type 2 diabetes mellitus.~   "
78622|NCT02537821|"~     Primary goal of this study is the analysis of HLA (Human leucocyte antigen) formation in~     severly burned patients. Potential HLA triggers in the treatment of severely burned patients~     are blood products, assist devices or temporary allogeneic skin. Besides that, inflammatory~     markers, such as WBC (white blood cell count), CRP (C-reactive protein), PCT (Procalcitonin)~     and two novel biomarkers (PSP (pancreatic stone protein), ST2) are to be investigated in~     severely burned patients.~   "
78623|NCT02537808|"~     The objective of this non-interventional study is to explore the safety, effectiveness and~     quality of life of lenalidomide / dexamethasone as first line treatment for~     transplant-ineligible patients with multiple myeloma in a real life setting.~   "
78624|NCT02537795|"~     In this study the investigators will use semi-structured interviews to qualitatively analyse~     patient and family member experiences with either deep brain stimulation or other forms of~     psychiatric neurosurgery.~   "
78625|NCT02537782|"~     Several attempts have been made to refine selection criteria for cardiac resynchronisation~     therapy (CRT) in heart failure patients with reduced ejection fraction (HFrEF). Previously~     proposed parameters probably do not sufficiently reflect the underlying mechanical~     dyssynchrony of the left ventricle (LV). Earlier work of our research group suggests that~     better candidate selection can rely on the direct observation or measurement of this LV~     mechanical dyssynchrony by means of non-invasive imaging. In this study apical rocking and~     other non-invasive measures of LV mechanical dyssynchrony will be applied to evaluate~     regional myocardial workload and metabolism, and determine their predictive value in CRT~     response.~   "
78626|NCT02537769|"~     The use of implantable left ventricular assist devices (LVAD) has increased over the last~     decade; partly because the newer continuous flow pumps feature a smaller design and better~     durability. These pumps have shown improved outcomes for those patients who don't qualify for~     heart transplantation and receive the LVAD device as a permanent therapy or a bridge to heart~     transplantation. Despite these improved outcomes, procedure related length of hospitalization~     for LVAD implantation is still 2 or 3 times that of other heart surgery treatments. One~     important reason for this is that many people experience right ventricular dysfunction after~     LVAD implantation. Treatment options for this are limited. Many LVAD patients with right~     ventricular dysfunction also have tricuspid valve regurgitation (TR). This is the failure of~     the tricuspid valve (TV) to close completely so that blood leaks backwards. Some recent~     studies suggest that correction of the TV during LVAD implantation has improved survival for~     those with severe regurgitation. However, this has not been evaluated for mild or moderate~     regurgitation.~      The goal of this study is to look at the clinical impact of surgical correction of mild to~     moderate TR in participants who are also undergoing LVAD implantation. The study will look at~     the degree of TR at various time points post-surgery, as well as any major cardiac adverse~     events, duration of hospitalization, and quality of life. The investigators hope to show that~     surgical correction of mild to moderate TR in LVAD patients will reduce right ventricular~     dysfunction and have a positive impact on health outcomes.~   "
78627|NCT02537756|"~     HPV vaccine coverage among adolescents in the US is suboptimal. This is particularly true~     among traditionally underserved adolescents. Few parent-targeted interventions have focused~     on the parental decision-making process. Self-persuasion, generating one's own arguments for~     engaging in a behavior, may be an effective means to influence parents' motivation to~     vaccinate their children. In a three-phase study, investigators are using quantitative and~     qualitative research methods to develop and refine a tablet-based self-persuasion~     intervention for parents who are undecided about the HPV vaccine. This clinical trial~     submission focuses on the second phase of the study. The results of the second phase will~     inform the third phase of the trial (also registered in clinical trials).~   "
78628|NCT02537743|"~     Evaluation of patient reported outcomes ( PRO) regarding typical ailments in the REAL LIFE~     Renal Cell Carcinoma population~   "
78629|NCT02537730|"~     Two week, Open Label, randomized, bilateral, crossover, 1 week of daily wear in each~     combination (lens / disinfecting cleaning system).~   "
78646|NCT02537496|"~     In this study the investigators aim at assessing and then enhancing neuroplasticity in the~     dorsolateral prefrontal cortex (DLPFC) and working memory - a key function of DLPFC - in~     patients with mild Alzheimer's disease (AD). The investigators will use Paired Associative~     Stimulation (PAS) paradigm to measure neuroplasticity and then a 4-week course of~     high-frequency repetitive Transcranial Magnetic Stimulation (rTMS) to the DLPFC to enhance~     cognitive function. Clinical and cognitive assessments will be done at baseline, one week,~     one month and 6 months after the rTMS course. Healthy controls will also be enrolled to carry~     out baseline cognitive assessments and a baseline measurement of neuroplasticity.~   "
78630|NCT02537704|"~     Obesity is the main modifiable risk factor for the development of chronic diseases in Mexico.~     Several randomized controlled trials have shown that intensive lifestyle programs are~     efficacious for the management of obesity. These programs include frequent sessions (14 or~     more contacts in the first 6 months) focused on diet and physical activity and use a behavior~     change protocol. In Mexico most primary care clinics and public hospitals apply traditional~     treatments for obesity management, which have limited effect on weight loss. This study would~     provide scientific evidence for an effective model for obesity management. Objective. The~     purpose of this study is to evaluate the effectiveness of the Group Lifestyle Balance~     Program for overweight and obesity management in adults, in primary care clinics and public~     hospitals from Sonora. This is a translational clinical study. Healthcare providers from the~     participating clinics will be trained with the Group Lifestyle Balance Program before its~     implementation. The primary outcome measurement is the change in body weight from baseline to~     6 months and 12 months. Changes in body mass index, waist circumference, systolic and~     diastolic blood pressure, depression, quality of life and stress scales will be measured in~     patients receiving the program before and 6 and 12 months after starting the program.~     Additionally, biochemical parameters (fasting glucose, total cholesterol, LDL-cholesterol,~     HDL-cholesterol, triglycerides, fasting insulin, Homeostatic Model Assessment- Insulin~     Resistance (HOMA-IR) and liver enzymes [Aspartate transaminase (AST), Alanine~     Aminotransferase (ALT)] will be evaluated from baseline to 12 months.~   "
78631|NCT02537691|"~     Prospective, single-arm, longitudinal, international, multicenter study in a real-world~     cohort of adult severe asthma participants being conducted to assess the relationships~     between asthma biomarkers and asthma-related health-outcomes for a period of 52 weeks.~   "
78632|NCT02537678|"~     Children who are exposed to traumatic events are at risk for developing PTSD and other mental~     health problems. Although effective treatments for childhood PTSD exist, service delivery~     approaches that are more accessible, efficient, and cost-effective are needed to improve~     access to evidence-based treatment. The proposed study furthers our pilot work and evaluates~     an innovative Stepped Care Trauma-Focused Cognitive Behavioral Therapy designed to optimize~     treatment in community settings and improve the value and efficiency of trauma-focused~     treatment for children compared to existing approaches, thereby reducing childhood PTSD and~     related societal impacts and costs.~   "
78633|NCT02537665|"~     To explore the effect of heating precondition of epidural catheter on the incidence of injury~     to blood vessel during epidural catheter placement.~   "
78634|NCT02537652|"~     Individuals who experience a stroke or transient ischaemic attack (TIA) are at heightened~     risk of subsequent vascular events, including heart attacks and secondary stroke/TIA. Blood~     pressure control is considered the most important contributor to positive health outcomes in~     stroke patients. The measurement of central blood pressure (cSBP) (the blood pressure which~     is being exerted at the heart), may provide clinicians with important diagnostic and~     prognostic information over and above that typically obtained from a peripheral blood~     pressure measure (the blood pressure in the arm). Central blood pressures may be better than~     traditional peripheral blood pressure measures as: i) peripheral blood pressure may not~     accurately reflect the effects of peak arterial blood pressure on centrally located organs,~     ii) central blood pressures may be 50 % superior to peripheral blood pressures when~     predicting cardiovascular events, and iii) information pertaining to central blood pressures~     may be more effective in the management of hypertension. While the validity of oscillometric~     devices which measure central blood pressures has been demonstrated, further study is~     required to determine precision under normal clinical operating conditions (i.e., reflective~     of the Hospital/GP practice setting). As such, this study will assess central and peripheral~     blood pressures of stroke patients when fasted and nonfasted, and when seated and supine. The~     study is interested in identifying the effect of the above parameters (fasted vs. unfasted,~     seated vs. supine) on central and peripheral blood pressures in stroke patients.~      Participants will take part in three separate assessment sessions, on three separate days,~     with a minimum 24 hour recovery between each session. Each assessment is expected to last 90~     minutes, with a minimum of eight blood pressures being taken from the left upper arm. As~     such, participants will be asked to give up 4.5 hours of their time to the study. During each~     assessment participants will be tested in a fasted and non-fasted state, and in a supine~     (lying) and seated position. All assessments will take place between 7 and 10am and will be~     undertaken following written informed consent.~   "
78635|NCT02537639|"~     The investigators would like to evaluate how well intensive care trainees without previous~     experience in transesophageal echocardiography are able to perform a transesophageal~     echocardiography study in the clinical setting after completing a simulator based training~     compared to conventional training.~   "
78636|NCT02537626|"~     This study evaluates the effect of applying low level laser light therapy to individuals with~     mild to moderate Alzheimer's disease to see if it may improve their memory, thinking and~     behaviors. Half of the participants will receive the real treatment with the laser device and~     the other half of the participants will receive a placebo treatment (not active laser).~   "
78637|NCT02537613|"~     This research study is evaluating a combination of two drugs, ibrutinib and obinutuzumab, as~     a possible treatment for Chronic Lymphocytic Leukemia (CLL).~   "
78638|NCT02537600|"~     The purpose of this study is to determine wether cobimetinib + vemurafenib combination~     treatment is effective in the treatment of BRAFV600-mutated melanoma patients with brain~     metastasis~   "
78639|NCT02537587|"~     The purpose of this study was to determine the effect of changing the amounts of resistant~     starch, whey protein and sugar on the blood glucose and insulin responses elicited by energy~     bars. The investigators also compared the glucose and insulin responses to the rates at which~     the food bars were digested in-vitro (in the test tube). The investigators thought increasing~     resistant starch and reducing sugar would reduce the glucose and insulin responses, and that~     adding protein would reduce glucose and increase insulin. The investigators also thought the~     glucose and insulin responses in people would be related to the rate of digestion of the food~     bars in-vitro.~   "
78640|NCT02537574|"~     This study will evaluate the safety, effectiveness and tolerance of low doses of oral~     naltrexone along with buprenorphine to treat opioid use disorder prior to the first injection~     of VIVITROL.~   "
78641|NCT02537561|"~     In this proposed study the investigators will combine gemcitabine and cisplatin with~     talazoparib to determine the recommended Phase 2 dose (RP2D) of this combination regimen.~     After determination of the RP2D patients with lung cancer whose tumors carry molecular~     alterations in DNA repair pathway genes will be enrolled to an expansion cohort to determine~     anti-tumor efficacy. Tissue samples of patients with confirmed partial response, complete~     response, and non-responders will be obtained for whole exome, and transcriptome sequencing~     to characterize the genetic alterations associated with response to therapy.~   "
78647|NCT02537483|"~     The primary objective of this study is to compare the efficacy, safety, and tolerability of~     IDP-120 Gel to IDP-120 Component A, IDP-120 Component B, and IDP-120 Vehicle Gel in subjects~     with moderate to severe acne vulgaris.~   "
78655|NCT02537379|"~     This post-marketing surveillance (PMS) study for Sovaldi® tablets (sofosbuvir, SOF)~     administered in combination with Copegus® tablets (ribavirin, COPE) will evaluate the safety~     and efficacy of SOF administered in combination with ribavirin under real world use in Japan.~     Among adult patients with chronic genotype 2 hepatitis C virus (HCV) infection and treated~     with SOF+ribavirin in routine clinical use, the primary objective of this study is to~     evaluate the incidence of adverse drug reactions (ADRs) under real world settings.~   "
78656|NCT02537366|"~     Crossover randomized controlled double blinded trial :~        -  The primary endpoint is the duration of Non Invasive Ventilation (NIV) session (minutes)~          with dexmedetomidine (DEX) or placebo.~        -  Secondary endpoints will be the sedation level as assessed by the Richmond Agitation~          Sedation Scale (RASS), the number of interventions to allow the completion of NIV~          session, the pain intensity level as assessed by visual analogue scale, the morphine and~          ketamine consumption during NIV sessions, the comparison of blood gas measurements~          before and after NIV sessions, the reproducibility of NIV cycles. The side effects of~          DEX will be notified.~   "
78657|NCT02537353|"~     The non-variceal upper gastrointestinal bleeding is defined as gastrointestinal bleeding~     located proximal to the angle of Treitz, whose cause is not related to esophagogastric~     varices or gastropathy of portal hypertension.~      Animal studies showed no absorption in the GIT and disposal within 48 hours of application,~     and no reported cases of obstruction. Recently, a prospective study involving 20 patients~     with upper gastrointestinal bleeding, showed that the application of hemospray ® promoted~     hemostasis in 95% of cases, confirmed by endoscopic revision 72h after application without~     any complication.~   "
78658|NCT02537340|"~     The hypothesis to be proven with this study is that the use of PET/MR on the initial staging~     of rectal cancers in patients with extramural vascular invasion detected by MR will detect~     more lesions than conventional work-up and will significantly impact on therapeutic decision,~     improving disease free and overall survival.~   "
78659|NCT02537327|"~     The aim of this study is to determine the incidence of recurrent caries around the different~     types of restorative materials (composites, amalgam, ceramics, crowns, etc.) and to better~     characterize recurrent caries lesions in terms of location and size of the lesions and type,~     material and age of the restoration.~   "
78660|NCT02537314|"~     The overall hypothesis of this proposal is that nutrient sensing in the foregut regulates~     metabolic hormone secretion and nutrient metabolism via enteric neural signals, and these~     mechanisms might be defective in obesity.~   "
78661|NCT02537301|"~     Group chat through the platform of mobile social networking provides an easily accessible,~     real-time and interactive channel for communication. With the help of mobile social app, a~     group of doctors with similar interests can share valuable cases, important papers and~     opinions through multiple media types (texts, images, and videos). It remains unknown what~     activities of Endoscopic Retrograde Cholangiopancreatography(ERCP) doctors on a group-chat~     platform are.~      In the beginning of 2013, a chatting group on Wechat (the most popular mobile social app in~     China), focusing on ERCP, was created. All the doctors who received and finished their ERCP~     training in Xijing Hospital of Digestive Diseases were invited to join in the platform. The~     contents in the chatting group were analyzed. The relationships between the chatting~     activities of ERCP doctors and the performance of ERCP (such as case volume, cannulation~     success rate and PEP etc.) were investigated.~   "
78662|NCT02537288|"~     The purpose of this study is to assess the electrocardiogram (ECG) effects of fedovapagon~     dose administration relative to placebo in healthy adult male and female subjects.~   "
78663|NCT02537275|"~     Investigators planned to investigate changes in visual function after wearing decorative~     tinted soft contact lenses with different pigment-free optical zone diameters.~   "
78664|NCT02537262|"~     Preoperative midnight NPO is a traditional method for preventing aspiration during general~     anesthesia. However, recent studies reported that drinking carbohydrate beverage, three hours~     prior the surgery helps reducing patients starving, uncomfortment, and fatigue without other~     complication. QOR 40 is developed for evaluating patients' recovery condition regarding~     physical, psychological, and social aspects. Enhanced Recovery After Surgery(ERAS) is a~     concept for reducing patients' hospital stay and helping recovery. Studies showed that~     drinking carbohydrate beverage made better recovery of bowel function and shorter hospital~     stay in colorectal surgeries. However, the effect of carbohydrate drink for laparoscopic~     surgery is not yet proved. Therefore, the investigators will show the effect of carbohydrate~     drinking through this study.~   "
78665|NCT02537249|"~     Dexmedetomidine is a selective α2 adrenergic agonist that can be considered analgesics,~     anxiolytic,and anti-stress effect . This randomized, double-blind placebo-controlled trial of~     intraoperative dexmedetomidine for improvement of quality of recovery and analgesia from~     surgery. Patients scheduled to undergo video-assisted thoracoscopic surgery (VATS) will be~     enrolled. Patients will be recruited before the date of their surgery and will complete the~     Quality of Recovery-40 (QoR-40) questionnaire before their surgery and at 24 and 48 hours~     post op. They will also complete clinically significant pains score and oxygenation from the~     postanesthetic recovery unit (PACU).~   "
78666|NCT02537236|"~     The positive patients to the Human Immunodeficiency Virus (HIV) with Highly Active~     Antiretroviral Therapy (HAART) present multiple alterations in their corporal composition and~     dyslipidemia, wich increase the cardiovascular risk.~      The investigators evaluated the efficiency of the combination of fish oil omega 3 fatty acids~     to different doses with the Therapeutic Lifestyle Changes (TLC) diet of the National~     Cholesterol Education Program on the profile of lipids and the corporal weight in patients~     with HIV treated with HAART.~   "
78667|NCT02537223|"~     This is a phase 1 study (the first step in testing a new drug or combination, to see how safe~     the drug and/or combination are) of investigational agent BYL719 in patients with locally~     advanced head and neck cancer (LA-SCCHN) in combination with standard radiation and~     chemotherapy (cisplatin).~      BYL719 is a new drug that is able to bind (attach to) and block a protein called PI3K-alpha.~     PI3K-alpha is part of an important pathway called EGFR/PI3K/Akt. A pathway is a series of~     chemical reactions among proteins in the cells that are involved in the support of normal~     cellular function. If the pathway is too active, due to changes in those proteins, the~     pathway can lead to tumor cell growth, survival and invasion. BYL719 has been shown to stop~     cancers in laboratory and animal studies.~      This study is the first time BYL719 will be combined with radiation and chemotherapy.~   "
78670|NCT02537184|"~     Objectives: To assess the beneficial and harmful effects of two recall intervals on caries~     incidence (primary outcome) in preschool children with high caries risk. The level of~     anxiety, oral health related quality of life (OHRQoL), time and cost (secondary outcomes)~     according to each interval will also be assessed. Methods: The sample will consist of 224~     children between 3-5 years of age, of both genders, with high caries risk according to the~     clinical criteria adapted from the Municipal Health Secretary of São Paulo. Children will be~     randomly allocated into two study groups: Group 1 (G1) - oral clinical examination +~     orientation for oral health and diet in return for 4 months; and Group 2 (G2) - oral clinical~     examination + orientation for oral health and diet in return for 8 months. An examiner~     calibrated and blinded to the study groups and the secondary outcomes will perform the~     clinical examinations, which consist of: gingival bleeding index, dental plaque index,~     detection of caries and its activity according to the ICDAS (International Caries Detection~     and Assessment System) and the clinical features of active and inactive caries lesions will~     be associated with the criteria discribed in ICDAS Commitee manual. An external dentist will~     conduct the assessment of the anxiety levels assessed by the Facial Image Scale, the OHRQoL~     measured by B-ECOHIS, the time and costs. All groups will be followed for an initial period~     of 16 months, totaling four follow-up visits for G1 and two follow-up visits to the G2. All~     analyzes will be performed by intention to treat (ITT) and considering the sensitivity~     analysis to assess the differences between the ITT analyzes and analyzes of complete cases.~   "
78671|NCT02537171|"~     The study is to evaluate the efficacy of Apatinib in patients with advanced or metastatic~     adenocarcinoma of stomach or gastroesophageal junction.~   "
78672|NCT02537158|"~     This study is a prospective non-randomized controlled study. The purpose of this study is to~     evaluate the validity and safety of sorafenib and transcatheter arterial chemoembolization~     (TACE) for microvascular invasion (MVI) in hepatocellular carcinoma (HCC) patients after~     radical surgery.~   "
78673|NCT02537145|"~     The aim of this pilot study is to determine the feasibility of Do-It-Yourself studies in~     pregnant women to detect changes in health parameters by assessing compliance and user~     experiences of participants. Besides, the measured health will be analysed to increase~     insight in physiological development in pregnant women.~   "
78674|NCT02537132|"~     The purpose of this study is to demonstrate that the adaptation to the Non Invasive~     Ventilation (NIV) at home is not worse when compared with an adaptation performed in~     inpatient settings.~   "
78675|NCT02537119|"~     Effectiveness of a technique of dynamic massage therapy in the hamstrings in patients with~     nonspecific low back pain.~   "
78676|NCT02537106|"~     Hyperosmotic solutions of 1.5% and 3% NaCl are equally effective for brain relaxation and~     microcirculation during brain surgery. The effect of 1.5% NaCl on postoperative natremia and~     natriuresis is less pronounced.~   "
78677|NCT02537093|"~     Specific Aims: This study aims to assess the acceptability of asynchronous~      telepsychiatry (ATP) and synchronous (STP) in rural Skilled Nursing Facility (SNF)~      population, in a 12-month randomized controlled trial. ATP relies on video recording of a~      psychiatric interview, where the video is later reviewed by a psychiatrist to make a~      psychiatric diagnosis and treatment recommendation to the primary treatment team.~      STP is real-time, face-to-face psychiatric assessment using video conferencing to come~      up with a psychiatric recommendation. People residing in SNFs generally rely on primary~      and consultant physicians to visit them and rarely have outpatient psychiatrist follow-up.~      SNFs offer more services than what is available to primary care office, and include 24-~      hours skilled nursing services, physical therapy, nutritional consultation, occupational~      therapy, social services, wound care, and psychiatric consultation when available. SNF~      residents are unable to live independently due to their multiple medical comorbidities~      and are therefore more medically ill than patients who are typically seen in primary care~      settings. The present study aims to demonstrate feasibility and to collect pilot data in~      SNFs. This study is funded by the UC Davis Behavior Health Center of Excellence grant~      via the California Mental Health Services Act (Prop 63). In a larger, future study, the~     investigators~      intend to demonstrate that ATP will be no different than STP in clinical outcomes but will~      be more accessible and cost effective.~   "
78678|NCT02537080|"~     The calcium channel blocker nimodipine dilates cerebral blood vessels and can pass through~     the blood-brain barrier, providing neuroprotective effects by selectively improving cerebral~     blood flow and inhibiting neuronal necrosis and apoptosis. Nimodipine significantly inhibited~     the production of tumor necrosis factor TNF-α and interleukin IL-1β, and also of nitric oxide~     and prostaglandin E2 from lipopolysaccharide-stimulated microglia. Abnormal cytokine networks~     are important in the development of nerve cell damage that leads to cognitive impairment.~   "
78679|NCT02537067|"~     The objective of this study is to evaluate the efficacy and safety of Chondron (Autologus~     Chondrocyte) in patients with cartilage defects in their ankle for 18 months~   "
78680|NCT02537054|"~     The purpose of this study is to determine whether Aflibercept (Eylea) is effective in the~     treatment of choroidal neovascularization and fibrovascular proliferation in patients with~     pseudoxanthoma elasticum (PXE) in terms of preservation or improvement of visual acuity.~   "
78681|NCT02537041|"~     SITUATION ON RESEARCH Diastolic heart failure (HF) or heart failure with preserved systolic~     function (SF) is the primary cause of heart failure in the elderly (over 2/3 of heart failure~     in patients over 60 years). Its main cause is hypertension. The diagnosis of diastolic heart~     failure is still controversial in clinical practice. It is based on ultrasound and biological~     criteria (or MRI). Basically, it is concerned patients making acute pulmonary edema with~     preserved SF and high BNP. It is now recognized that the primum movens of this type of HF~     is increased myocardial stiffness secondary to LVH. Noninvasive assessment of this parameter~     would allow a more accurate and reliable diagnosis because not dependent on load conditions~     unlike the ejection fraction (EF) and trans-mitral Doppler. However, the absence of~     non-invasive tool for the direct evaluation of the diastolic stiffness (so-called passive)~     prevents to date to use this diagnostic parameter.~      The investigators propose here to evaluate noninvasively myocardial stiffness in elderly~     patients with diastolic heart failure using a new imaging tool that uses an innovative~     ultrasonic technology, the ultrafast echo associated with its elastography function~     ShearWave Imaging (SWI). The investigators work for several years in collaboration with the~     Langevin Institute on this technology which was recently validated in experimental models.~     Its principle is based on the creation of a shear wave from a standard ultrasound and~     calculating the velocity of this wave with the high time resolution of the ultrasound probe,~     this being correlated with the speed myocardial stiffness.~      The human study was recently made possible by the development of a phased array probe having~     the opportunity to work with elastography mode (SWI).~      PURPOSE OF RESEARCH The goal will be to demonstrate the interest of the non-invasive~     evaluation by ultrafast echo (SWI) of myocardial stiffness in the diagnosis of diastolic~     heart failure in the elderly.~   "
78682|NCT02537028|"~     The primary purpose of this Phase 1b double-blind, randomized, placebo-controlled trial is to~     evaluate the safety, tolerability, pharmacokinetic (PK), and biological effect of MSC2364447C~     administered for 4 weeks in systemic lupus erythematosus subjects (SLE).~   "
78683|NCT02537015|"~     This study evaluates the long-term (9-months) safety of the Bimatoprost Ocular Insert in~     subjects with Glaucoma or Ocular Hypertension. All the subjects will receive Bimatoprost~     Ocular Insert and will wear it for approximately 3 months (12 weeks), then will have a that~     Insert removed and a new Insert placed for another 24 weeks (approximately 6 months).~   "
78684|NCT02537002|"~     The purpose of this study is the following:~        -  To determine the safety and tolerability of single ascending intravenous (IV) doses of~          PF-05230907 in healthy Japanese subjects.~        -  To characterize the PK profile of single ascending IV doses of PF-05230907 in healthy~          Japanese subjects.~        -  To characterize the PD profiles of single ascending IV doses of PF-05230907 in healthy~          Japanese subjects.~        -  To evaluate the immunogenicity of PF-05230907 in healthy Japanese subjects~   "
78685|NCT02536989|"~     The investigators will include those patients with adherent clot on gastric or duodenal~     ulcers after endoscopic confirmation After receiving well explanation and giving written~     consent, they are enrolled and will be allocated to 2 groups randomly. Those in the first~     group will receive intravenous omeprazole 40 mg stat and then 40 mg q12h. Those in the second~     group will receive intravenous omeprazole 80 mg stat and then 8mg/hr infusion. The patients~     in both groups will receive intravenous omeprazole for 3 days and then oral esomeprazole qd~     for further treatment of peptic ulcer.~      The investigators define rebleeding during admission and within 30 days as primary end points~     and define surgical intervention for ulcer bleeding, transfusion amount and hospitalization~     days after allocation as secondary end points.~   "
78686|NCT02536976|"~     There is a high prevalence of OAB symptoms among patients with Parkinson's disease and a lack~     of pharmacotherapies with an acceptable side effect profile. Specifically, available~     anticholinergic medications have a high risk of cognitive side-effects, which preclude their~     use in PD patients with CI. PD can also cause a number of non-motor symptoms that are likely~     to be adversely affected by the currently available anticholinergic agents. Mirabegron is the~     first pharmacologic treatment which may not exacerbate CI, constipation, orthostatic~     hypotension (OH), somnolence, and dry mouth in PD.~   "
78687|NCT02536963|"~     Amblyopia (lazy eye) and strabismus (misaligned eyes) are medical eye conditions that~     combine as the leading causes of preventable vision loss in children. They are irreversible~     if not detected and corrected by the age of seven, however half of all cases are missed~     because the conditions do not always manifest themselves and pediatricians are unable to~     reliably detect the conditions. The current health care system badly needs an accurate and~     effective approach toward detecting amblyopia and strabismus in preschool children.~      The study will be conducted in busy, ethnically and racially diverse primary care sites~     operated by the Kaiser Permanente system and compare the outcomes of testing with a Pediatric~     Vision Scanner with outcomes the current standard of care.~   "
78688|NCT02536950|"~     This is an open-label, non-randomized, pilot study to determine the safety and feasibility of~     the insulin-only bionic pancreas.~   "
78689|NCT02536937|"~     Primary Objective:~      To study the effect of mild, moderate, and severe renal impairment on the pharmacokinetics~     (PK) of eliglustat.~      Secondary Objective:~      To assess the tolerability of eliglustat tartrate given as a single dose in subjects with~     mild, moderate, and severe renal impairment in comparison with matched subjects with normal~     renal function.~   "
78690|NCT02536924|"~     Crisis Teams are now a well established part of the mental health system. These teams are~     effective in providing crisis management, treatment, referral, and educational services. We~     are testing a waiting room intervention for the patients attending a Crisis Team. As far as~     we are aware, no trial of a waiting room intervention has been reported in a psychiatric~     setting. This is a preliminary study using a Randomized Control Trial (RCT) Design. Patients~     (N =40) will be randomly allocated to either the treatment or the control group, and will be~     selected from the local Crisis Team. The treatment group will receive a waiting room~     intervention called, RESOLVE (Relaxation, SOLving problem and cognitiVe Errors), that is a~     short film, Plus Treatment As Usual (TAU), and the control group will receive only TAU.~     Patients in both groups will be assessed before and after the intervention, using the HADS~     (Hospital Anxiety And Depression Scale), CORE (Clinical Outcome in Routine Evaluation), (to~     measure psychopathology) and WHODAS (World Health Organization Disability Assessment~     Schedule) (for functioning). We hypothesize that the treatment group will demonstrate~     significant improvement in mental health and functioning, compared to the control group.~     Analyses will be conducted using SPSS v22, and will consist of a t-test or Chi Square test to~     measure the baseline differences, and a linear regression to compare the differences between~     the two groups at the end of the intervention. Results will be published in international~     journals and will be presented in local and international conferences.~   "
78691|NCT02536911|"~     Primary Objective:~      To study the effect of mild and moderate hepatic impairment on the pharmacokinetics (PK) of~     eliglustat.~      Secondary Objective:~      To assess the tolerability of eliglustat tartrate given as a single dose in subjects with~     mild and moderate hepatic impairment in comparison with matched subjects with normal hepatic~     function.~   "
78692|NCT02536898|"~     The main aim is to assess the effectiveness of introducing a standardized intervention~     program for treatment of patients with a fragility fracture as measured by changes in the~     fracture rates and the mortality.~   "
78693|NCT02536885|"~     Permanent and temporary cognitive impairment in the perioperative period is of great~     importance to patients. Hypoperfusion due to the intraoperative hypotension is often~     mentioned as a possible cause of postoperative cognitive dysfunction.~   "
78721|NCT02536521|"~     This prospective observational study aimed to identify the intraoperative variables to~     predict the hemodynamic change according to intra-abdominal pressure in the children~     undergoing laparoscopic surgery.~      The intraoperative variables includes Pulse pressure variation (PPV), systolic pressure~     variation (SPV), stoke volume variation (SVV), Pulse oximeter plethysmographic waveform~     amplitude (△POP),and pleth variability index (PVI).~   "
78722|NCT02536508|"~     Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects with~     Moderate to Very Severe Chronic Obstructive Pulmonary Disease~   "
78694|NCT02536872|"~     The concept of organisms living on or in the human body without causing overt signs of an~     infection is common in medicine and has been termed a microbiome. Urine from patients with~     Overactive bladder (OAB) grows different organisms from controls without OAB. However, it is~     not known if the bacteria that have been identified are innocent commensals or pathogenic~     organism responsible for the symptoms of OAB. Previous data suggests that treatment with~     antibiotics does lead to an improvement in overactive bladder symptoms in a large number of~     patients. On this basis the investigators now treat are patients with similar antibiotic~     regimes. If antibiotics improve symptoms it would be expected that they would return the~     microbiome back to how it is in patients without OAB. This study aims to identify the effects~     of antibiotics on the urinary microbiome and to identify/confirm if antibiotic treatments~     cause improvement in OAB.~   "
78695|NCT02536859|"~     This trial is conducted in Europe. The aim of this trial is to compare pharmacodynamic (the~     effect of the investigated drug on the body) and pharmacokinetic (the exposure of the trial~     drug in the body) properties of insulin degludec and insulin glargine 300 U/mL at~     steady-state conditions in subjects with type 1 diabetes mellitus.~   "
78696|NCT02536846|"~     The primary aim of this study is to investigate antipsychotic drug effects on healthy brain~     metabolism.~   "
78697|NCT02536833|"~     The purpose of this study is to assess the efficacy, safety, and tolerability of three~     different strengths of SM04690 injected in the target knee joint of moderately to severely~     symptomatic osteoarthritis subjects.~   "
78698|NCT02536820|"~     The Psychoneuroimmunotherapy (PNIT) is the study, modification and implementation of the~     interactions between the processes of adaptive behavior, neurological, endocrine and immune.~      Among its premises assuming homeostasis or physiological balance as an integrated process~     involving the systems above mentioned.~      Additionally, among the basics theme the re-mean is introduced, ie changing the direction,~     the function of a concept from a negative context carry a positive meaning, so that from the~     PNIT no disease is seen as a problem but as a situation to solve. The patient then transmits~     the importance of which will come.~      Primary objective:~      To investigate whether patients on PNIT have a higher proportion of patients achieving~     disease control (<7% in glycosylated hemoglobin (HBAC1) and quality of life compared with~     conventional treatment patients.~      Methodology:~      quasi-experimental, simple blind, simple blind, parallel, phase III clinical trial The~     investigators will follow a group of patients with type 2 diabetes mellitus durgin three~     months with an interim analysis a month after receiving the intervention (two visits) During~     each visit a trained PNIT physician assess the effectiveness, safety and quality of life of~     each patient.~      The investigators will include male or female patients aged 18 years-old with diabetes~     mellitus type II in any severity, uncontrolled (> 7% Glycosilated Haemoglobin (HbAc1)) and~     any treatment regimen included.~      The patients are not allocated by a random process and the investigators will have a~     convenience sample~      The investigators will perform an intention to treat analysis, patients will be analyzed~     according to the intervention received even if this was different from the one they were~     assigned.~   "
78699|NCT02536807|"~     Open gingival embrasures, also called black triangles, may occur after surgical~     intervention or tooth replacement by an implant. They are perceived as anaesthetic by most~     patients and causing functional and phonetic problems. The aim of the present study is to~     assess the effect of injection of hyaluronic acid for papilla augmentation next to an implant~     restoration in a clinical controlled double-blinded randomized trial with 6 months follow-up.~   "
78700|NCT02536794|"~     The main purpose of this study is to determine the anti-tumor activity of MEDI4736 in~     combination with tremelimumab in patients with metastatic HER2-negative breast cancer. Both~     MEDI4736 and tremelimumab are antibodies (proteins used by the immune system to fight~     infections and cancers). MEDI4736 attaches to a protein in tumors called PD-L1. It may~     prevent cancer growth by helping certain blood cells of the immune system get rid of the~     tumor. Tremelimumab stimulates (wakes up) the immune system to attack the tumor by inhibiting~     a protein molecule called CTLA-4 on immune cells. Combining the actions of these drugs may~     result in better treatment options for patients with breast cancer.~   "
78701|NCT02536781|"~     The purpose of this study is to compare the oral inflammatory reduction effect caused from~     orthodontic treatment of anthocyanin and placebo mouthrinse.~   "
78702|NCT02536768|"~     NOTE THAT THE STUDY IS LED BY SOUTH AFRICA NATIONAL DEPARTMENT OF HEALTH AND WORLD BANK WITH~     SUPPORT FROM BOSTON UNIVERSITY. The South Africa National Department of Health (NDOH) intends~     to launch its newly developed National Adherence Guidelines for Chronic Diseases (HIV, TB and~     NCDs) throughout South Africa in the coming year. Early implementation of the minimum~     package of interventions described in the Adherence Guidelines for HIV patients will take~     place at 12 primary health clinics and community health centres in four provinces starting in~     July 2015. To maximize the learning potential of this early implementation stage, NDOH will~     match the intervention clinics with 12 comparison clinics and randomly allocate intervention~     or comparison status within the pairs of clinics. This will allow the outcomes of the~     interventions to be evaluated using a cluster-randomized design and generate data on the~     costs of implementation and the potential need for adherence support for the other diseases~     addressed in the guidelines (tuberculosis, hypertension, and diabetes). This protocol is for~     the evaluation, which will generate information on the effectiveness of minimum package~     interventions and help improve the design, implementation, and budgeting of the guidelines.~   "
78703|NCT02536755|"~     Primary Objective:~      Evaluate long term skeletal response to eliglustat in adult patients who successfully~     completed one of the Phase 2 or Phase 3 eliglustat studies.~      Secondary Objective:~      Evaluate the safety of eliglustat (by [serious] adverse event [AE] continuous monitoring),~     the quality of life (Short Form-36 Health Survey [SF-36]) and biomarkers of Gaucher disease~     type 1 (GD1) (chitotriosidase, plasma glucosylceramide [GL-1] and lyso glucosylceramide~     [lyso-GL-1]) in adult patients who successfully completed one of the Phase 2 or Phase 3~     studies.~   "
78704|NCT02536742|"~     This international, multicenter, prospective single arm Phase II biomarker discovery clinical~     trial with the primary objective of assessing the association of PFS with gene mutations,~     gene copy number aberrations and gene signatures in post-menopausal women with hormone~     receptor positive, HER2-negative metastatic or locally relapsed breast cancer whose disease~     has progressed after prior adjuvant endocrine therapy or one line systemic treatment, i.e.,~     endocrine treatment or chemotherapy, administered for metastatic disease.~   "
78705|NCT02536729|"~     Objective: The primary objective of this study is to assess the quality of life of people~     treated with oral phosphate compared with polyethylene glycol + electrolytes to imaging~     procedures, according to the outcome variables reported by patients.~      Type of study: A non-interventional observational analytic prospective cohort study.~      Sample: We will include people who need bowel cleansing for the realization of imaging tests~      Exposures: - oral sodium phosphate normal regimen~        -  Oral sodium phosphate with modified diet~        -  Polyethylene Glycol + electrolytes~      Follow-up time: 8 days after the bowel preparation~      Outcomes: Boston Scale measure Safety Differences between groups in blood test (Sodium,~     Potassium, Calcium)~   "
78706|NCT02536716|"~     To compare platform-switched implants to platform-matched implants for replacement of a~     single missing tooth and their effect on: 1) Interproximal alveolar crest level in relation~     to implant platform. 2) Buccal implant recession. 3) Presence or absence of black triangle~     apical to the contact point. 4) Implant Success. 5) Adequate buccal tissue thickness.~   "
78707|NCT02536703|"~     To confirm the safety and efficacy of the Lotus™ Valve System in the Chinese population for~     Transcatheter Aortic Valve Implantation (TAVI) in symptomatic patients with severe aortic~     stenosis.~   "
78708|NCT02536690|"~     Propofol in combination with remifentanil or midazolam can result in synergistic or additive~     effect.~      The patients who are scheduled to undergo general anesthesia are enrolled in this study. 120~     patients will be randomly allocated to 3 groups(P, PR, PMR). The patients in group P will~     receive general anesthesia only with propofol and group PR and PMR will receive 0.25~     mcg/kg/min remifentanil infusion prior to propofol. The patients in group PMR will receive~     0.03 mg/kg bolus dose of midazolam 1 min after start of the remifentanil infusion. 'Success'~     is defined as loss of both verbal response and eyelash reflex in 2 min after propofol~     administration. When 'success', the next patient will receive the same dose(in 18/19~     probability) or 0.25 mg/kg lower dose(in 1/19 probability) of propofol. When 'failure', the~     next patient will receive 0.25 mg/kg higher dose of propofol at induction period.~   "
78709|NCT02536677|"~     EMPACT is the first attempt to comprehensively evaluate the current emergency care of acute~     chest pain from a regional representative sample in China.Findings will allow new~     opportunities to facilitate the clinical quality improvements and ultimately reduce the~     mortality and health care burden in patients with acute chest pain. It also will help to~     establish a regional network and database for further research and performance improvement.~   "
78710|NCT02536664|"~     It is a non-interventional study with a duration of approximately 24 months per participant~     to investigate the therapeutic efficiency, safety and treatment regimens of Rituximab~     maintenance therapy in daily routine in participants with previously untreated, relapsed or~     refractory cluster of differentiation 20 (CD20)-positive follicular lymphoma (FL) in clinical~     practice.~   "
78711|NCT02536651|"~     There are no validated patient-reported outcome measures to assess lower extremity function~     in Finnish language. The present study aimed to 1)translate and culturally validate the~     Finnish versions of the Visual Analogue Scale Foot and Ankle and the Lower Extremity~     Functional Scale, and 2) study the psychometric properties of these two questionnaires~   "
78712|NCT02536638|"~     The purpose of this research study is to compare the amount of protein excreted by the~     kidneys in a 24-hour period between patients who have a kidney infection and those who do not~     have a kidney infection.~   "
78713|NCT02536625|"~     NK (Natural Killer) cells are important in the fight against tumor, especially for the~     control of cancer metastasis. The purpose of this prospective study is to evaluate the impact~     on lymphocytes NK functions and development of an everolimus treatment in women treated for a~     metastatic breast cancer. In particular, the study of lymphocytes NK functions and~     development under everolimus treatment could permit to validate an early biomarker of the~     impact of everolimus on these NK cells.~   "
78714|NCT02536612|"~     The purpose of the study is to test feasibility and acceptability of a lottery to help women~     in Cape Town, South Africa to continue using long-acting reversible contraceptives to avoid~     unintended pregnancies, and to also use condoms to reduce sexually transmitted infections~     including HIV.~   "
78715|NCT02536599|"~     The aim of the study is to identify clinical and laboratory parameters, present at the time~     of initial evaluation that could help predict which children with cancer, fever, and~     neutropenia will be at risk for developing clinically documented infections and/ or~     complications.~   "
78716|NCT02536586|"~     The main purpose of this study is to evaluate the tolerability of an investigational drug~     known as LY3023414 in Japanese participants with advanced cancer or cancer that has spread to~     another part(s) of the body. The study will also explore the safety of the drug. It will~     measure how much of the drug gets into the blood steam and how long the body takes to get rid~     of it. It will investigate anti-cancer activity.~   "
78717|NCT02536573|"~     This is a prospective, randomized study of total hip arthroplasty with and without the use of~     Radlink surgical positioning software. The investigators are interested in discovering~     whether the use of the Radlink software will provide more accurate acetabular cup position~     when compared with surgeon estimates based on visual inspection of fluoroscopic images.~   "
78718|NCT02536560|"~     In this prospective observational cohort study the potential clinical consequences of~     antibiotic use in early life and perturbations in the gastrointestinal microbiota composition~     due to that antibiotic use are studied. It is hypothesized that altered microbiota may be an~     important underlying mechanism for impediments in the developing immune system.~      Differentiation will be made between a group of neonates who received antibiotics in the~     first week of life, and control infants who were not exposed to antibiotics in the neonatal~     period.~   "
78719|NCT02536547|"~     This study evaluates the respective values and combined CPIS (Clinical Pulmonary Infection~     Score), bronchoalveolar lavage (BAL), tracheal aspiration and pulmonary ultrasonography (LUS~     - Lung Ultrasound) for early diagnosis of ventilator- associated pneumonia (VAP).~   "
78720|NCT02536534|"~     Evaluate the correlation between activity level (monitored by Fitbit Flex remote activity~     tracker) and 6-minute walk distance (6MWD) (performed by investigator) in patients with~     Pulmonary Arterial Hypertension (PAH) or Chronic Thromboembolic Pulmonary Hypertension~     (CTEPH) over 6 months in routine clinical practice settings.~   "
78723|NCT02536495|"~     This phase I/II trial studies the side effects and best dose of selinexor and docetaxel and~     to see how well they work when given together in treating patients with squamous cell lung~     cancer that has come back or spread to other places in the body. Selinexor may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Giving selinexor together with docetaxel may work better in treating squamous cell~     lung cancer.~   "
78724|NCT02536482|"~     It is a study to assess the tolerance to a new commercially available infant formula in~     children affected by Cow`s Milk Allergy.~   "
78725|NCT02536469|"~     A phase Ib, dose escalation, multiple dose trial with HuMax-IL8 in patients with metastatic~     or unresectable, locally advanced malignant solid tumors.~   "
78726|NCT02536456|"~     China PEACE Millions Persons Project is a national screening project for cardiovascular~     disease in China. This Project was approved by National Health and Family Planning Commission~     (NHFPC), China and founded by Ministry of Finance, China in 2014.~      The specific objectives of the project are to:~        1. identify subjects at high-risk of CVD and provide counseling for medication and~          lifestyle improvements~        2. evaluate the feasibility of such screening methods for subjects at high risk of CVD, and~          to assess the effect of health counseling on CVD incidence rates and risk factors~          control~        3. inform future intervention and long-term follow up efforts for primary and secondary CVD~          prevention in China.~   "
78727|NCT02536443|"~     The Contemporary Modalities In Treatment of Heart Failure Registry (COMMIT-HF) is an~     observational study on an all-comer systolic heart failure population hospitalized in a~     highly specialized cardiovascular center. The aim of the study is to assess the clinical~     characteristics, treatment modalities and prognosis in this population.~   "
78728|NCT02536430|"~     The aim of this study was to determine whether combining an intraoral injection of a non~     steroidal anti-inflammatory drug (Ketorolac), in association with conventional inferior~     alveolar nerve block, would improve the success rate in teeth with irreversible pulpitis.~     Forty adult volunteers with including criteria has been randomly divided into two groups~     (n=20). All patients received standard inferior alveolar nerve block injection. After~     achieving the lip numbness, one group received a buccal infiltration of Ketorolac and the~     other one received a buccal infiltration of Normal Saline as placebo. Any pain during root~     canal treatment has been recorded using analog visual scale. The success was considered as~     none or mild pain during treatment. The data have been analyzed using Mann-U-Whitney and~     chi-squared tests.~   "
78729|NCT02536417|"~     The purpose of this study is to determine if melatonin administration to end-of-life patients~     is effective in preventing the development of delirium compared with those who do not receive~     this treatment. Delirium is a difficult to control symptom commonly seen in patients at the~     end-of-life. A person who is delirious is unable to think clearly and cannot make sense of~     what is going on around him/her.~   "
78730|NCT02536404|"~     The purpose of this study is to determine whether etrasimod (APD334) is a safe and effective~     treatment for ulcerative colitis after 52 weeks of treatment.~   "
78731|NCT02536391|"~     This Phase I, open-label, randomized, 3-period crossover study was designed to determine the~     relative bioavailability of ipatasertib administered as capsule and tablet formulations to~     healthy volunteers. In addition, the influence of food on ipatasertib exposure will also be~     determined. Participants will be randomized to one of six treatment sequences to receive~     three treatments of a single oral administration of ipatasertib in, 1) tablet formulation in~     the fasted state, 2) capsule formulation in the fasted state or 3) tablet formulation in the~     fed state. Pharmacokinetics will be assessed, and standard physical and clinical evaluations~     will be performed throughout the study. Time on study is expected to be 3 weeks.~   "
78732|NCT02536378|"~     The ROADSTER 2 Study is intended to evaluate real world usage of the ENROUTE Transcarotid~     Stent when used with the ENROUTE Transcarotid Neuroprotection System by physicians of varying~     experience with the transcarotid technique.~   "
78733|NCT02536365|"~     A common feature of ASD is over or under sensitivity to the environment and difficulty~     putting sensory information together in an orderly way, referred to here as sensory issues.~     Building on previous work, this study will test the efficacy of Sensory Integration Therapy~     (SIT), a non-invasive intervention to improve functional skills in children with ASD, in~     comparison to commonly applied ABA behavioral treatments, in the treatment of ASD symptoms. A~     total of 180 children with ASD and sensory issues in the greater New York City Metropolitan~     area will complete this study.~   "
78734|NCT02536352|"~     The purpose of this study is to determine whether fluoride supplementation during pregnancy~     is effective in extending the length of gestation and improving overall perinatal well-being.~   "
78735|NCT02536339|"~     This study will examine the safety and efficacy of pertuzumab in combination with high-dose~     trastuzumab in adult participants with HER2-positive MBC with CNS metastases and disease~     progression in the brain following radiotherapy.~   "
78736|NCT02536326|"~     The purpose was to evaluate 6-month outcomes of renal denervation(RDN) for the treatment of~     resistant hypertension in Chinese patients in a prospective cohort study.~   "
78737|NCT02536313|"~     The primary objective of this study is to evaluate the efficacy, safety, and tolerability of~     the treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination~     (FDC) ± ribavirin (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV)~     infection and prior treatment experience with a direct acting antiviral (DAA).~   "
78738|NCT02536300|"~     This study will optimize the safety and efficacy of chronic administration of idelalisib in~     participants with follicular lymphoma (FL) and evaluate the overall safety profile of~     idelalisib and the overall response rate (ORR) by Week 24.~   "
78739|NCT02536287|"~     The purpose of this study is to compare short-term and long-term efficacy of total~     parathyroidectomy with autotransplantation and total parathyroidectomy without~     autotransplantation for Secondary hyperparathyroidism.~   "
78797|NCT02535533|"~     This is a Phase 1 trial for safety and preliminary efficacy of the combination of axitinib~     and selenomethionine (SLM) for adult patients with advanced metastatic clear cell renal cell~     carcinoma (CCRCC). This will be a two part study consisting of a dose escalation and~     expansion study.~   "
78740|NCT02536274|"~     Aim of the study is to analyze systematically by using surface EMG the effect of the dynamic~     flexion orthosis Dynaflex® and the back bandage Lumbo Sensa® on the voluntary activation of~     the low back muscles and thereby on the muscles' stiffness.~      Patients have to pass a course with 6 different exercises in which they have to carry out~     certain activities of daily life under controlled conditions to examine, if the particular~     technical aid has a positive impact on pain-related activation of the back muscles.~   "
78741|NCT02536261|"~     The purpose of this study is to observe whether dopamine agonists can be safely withdrawn~     after the tumor volume and prolactin level of invasive prolactinomas involving the cavernous~     sinus have been effectively controlled through pharmacological treatment.~   "
78742|NCT02536248|"~     Inflammatory processes are increasingly being recognized as a critical step in the~     pathogenesis of both diabetes and heart disease and may constitute a biological link between~     the two diseases. Inflammatory cytokines increase vascular permeability, change~     vasoregulatory responses, increase leukocyte adhesion to endothelium, and facilitate thrombus~     formation by inducing procoagulant activity, inhibiting anticoagulant pathways, and impairing~     fibrinolysis. Leukocyte adhesion to arterial endothelial cells is thought to be an important~     step in the development of atherosclerosis, and adhesion molecules, such as intercellular~     adhesion molecule-1 (ICAM-1) and L-selectin, play key roles in this process. Therefore,~     identifying novel therapeutic approaches that would favorably affect inflammation,~     endothelial function, and glucose is of significant interest. Investigators have recently~     demonstrated that, relative to placebo, sitagliptin treatment resulted in a significant~     reduction in plasma levels of various inflammatory markers and cell adhesion molecules. The~     results also suggest that the beneficial effects of sitagliptin on both inflammation and~     endothelial function are most likely mediated by an elevation in plasma GLP-1 levels and~     global improvement of the glucose-insulin homeostasis. However, the mechanisms underlying the~     beneficial effects of sitagliptin on these markers remain to be fully elucidated. The~     proposed study will address this key issue.~   "
78743|NCT02536235|"~     Paracervical blocks are routinely used in first trimester surgical abortions and are a proven~     method for decreasing procedural pain. Even when paracervical anesthesia is used, an~     overwhelming majority of women still report at least moderate pain during a first trimester~     abortion procedure. Other than some non-pharmacologic modalities (music and visualization),~     only the addition of intravenous medication has been shown to reduce procedural pain. Applied~     topical heat is effective in alleviating pain in other medical subspecialties, and in~     gynecology has been shown to reduce pain from dysmenorrhea, but has never been studied for~     intraoperative pain control during first trimester abortion.~      The investigators plan to conduct a double-blinded, randomized, controlled trial~     investigating the utility of topical heat application as an adjunct to paracervical block in~     first trimester surgical abortions up to 12 6/7wks. The primary outcome is pain score,~     measured using VAS, at time of uterine aspiration. As secondary outcomes, the investigators~     will look at the effect of heat application on pain at time of speculum placement,~     paracervical block, tenaculum placement, cervical dilation and overall pain. Patient~     satisfaction will also be assessed. If found to reduce pain during abortion under local~     anesthesia, the use of heat could offer an inexpensive, safe and universally available~     adjunct to the paracervical block during this procedure.~   "
78744|NCT02536222|"~     The work will be conducted in six health posts in the regions of Matam (Kanel and Ranérou~     districts) and Louga (Linguère district), that were selected in 2014 on the basis of the~     malaria incidence rate, the heterogeneity of transmission between villages in the health post~     catchment areas, their proximity, and the availability of historical data from before 2014.~     Malaria elimination strategies were already implemented in the same health posts in 2014 and~     are still ongoing, thus this protocol aims to strengthen these activities. Seven health posts~     with similar characteristics but with a slightly lower incidence rate were chosen as~     controls. It will be implemented in all villages in the six intervention health posts and it~     will consist of investigating all passively detected cases (index cases) and conducting focal~     test and focal drug administration (FT/FDA) with dihydroartemisinin-piperaquine (DHAP) in all~     index case and neighboring households with a positive RDT. All household members in~     households with a positive RDT will be treated, regardless of their RDT results. Impact of~     the enhanced Step D on malaria incidence and prevalence will be evaluated using before-after~     comparison and compared to the change in the control health posts and the operational aspects~     will be assessed for subsequent scale up.~   "
78745|NCT02536209|"~     The purpose of this study is to investigate the pharmacodynamic effect of single doses of~     MT-8554 in healthy subjects.~   "
78746|NCT02536196|"~     The Keystone Heart TriGuard™ HDH is an aortic embolism deflection device intended to reduce~     the amount of embolic material that may enter the carotid, subclavian, and vertebral arteries~     during transcatheter heart valve implantation.~      The objective of the study is to assess the safety and efficacy of the TriGuard™ HDH embolic~     deflection device in patients undergoing transcatheter aortic valve implantation (TAVI), in~     comparison with an active control group of patients undergoing unprotected TAVI.~      Subjects with indications for TAVI and who meet study eligibility criteria will be randomized~     2:1 to one of two treatment arms: 1) Intervention: Embolic protection device (TriGuard™) with~     transcatheter aortic valve implantation or 2) Control: Unprotected transcatheter aortic valve~     implantation.~   "
78747|NCT02536183|"~     This study is looking to determine the maximum tolerated dose (MTD) and recommended phase 2~     dose (RP2D) of lyso-thermosensitive liposomal doxorubicin (LTLD) administered in combination~     with MR-HIFU in children with relapsed/refractory solid tumors, which may include but are not~     limited to rhabdomyosarcoma and other soft tissue sarcomas, Ewing's sarcoma family of tumors,~     osteosarcoma, neuroblastoma, Wilms' tumor, hepatic tumors, and germ cell tumors.~   "
78748|NCT02536170|"~     The aim of this study is to determine whether giving extra arginine, a simple amino acid, to~     patients with sickle cell disease seeking treatment for a pain crisis (vaso-occlusive painful~     events (VOE) will decrease pain scores, decrease the need for pain medications or decrease~     length of hospital stay or emergency department visit. Funding Source - FDA OOPD.~   "
78818|NCT02535260|"~     This study will assess the use of the new Clearblue Advanced Fertility Monitor in a home~     setting for three menstrual cycles or until pregnancy is achieved (whichever comes first) by~     female volunteers seeking to get pregnant.~   "
78749|NCT02536157|"~     Which splinting method produces the best outcomes (in range of movement, pain and function)~     in the non-operative treatment of stable volar plate injuries in adults?~      The volar plate is a ligament located at the middle knuckle (proximal interphalangeal joint -~     PIPJ) of the finger. It is commonly injured through hyperextension, for example a ball~     hitting the fingertip. Current treatment in the Hand Therapy Unit involves splinting the~     injured joint dorsally (on the back of the finger) into 20⁰ flexion (bent) using~     thermoplastic material. However, there is a potential risk of developing permanent stiffness~     of the PIPJ into straightening, once the volar plate ligament heals. To reduce this risk, the~     study aims to investigate if using a volar (on the front of the finger) gutter splint in 0⁰~     flexion (straight), which still prevents hyperextension, achieves better outcomes. There is~     no existing high-quality evidence comparing these two methods.~      This is a randomised controlled trial. For the purposes of this study, the current treatment~     of a 20° dorsal block splint will act as the control group. The intervention group will be~     the volar gutter splint group. A convenience sample will be used and all patients (over 16~     years old) presenting to the Mid Yorkshire Hospitals NHS Trust's Hand Therapy Unit will be~     invited to participate in the study, with consideration to inclusion/exclusion criteria.~     Participants will be randomised into one of two groups through the use of a random number~     generator. The outcomes assessed will be range of movement, pain and function. These will be~     measured at initial assessment, four and twelve weeks. These are all average normal time~     intervals that patients are seen. Each splint is worn for four weeks and participants will~     receive standardised advice, exercises and treatment.~   "
78750|NCT02536144|"~     This study is to determine the feasibility and safety of magnetic-controlled capsule~     endoscopy system in examination of human colon under the real time monitoring by colonoscopy~     in the clinical application.~   "
78751|NCT02536131|"~     Longitudinal Investigation of intestinal microbiome, fecal inflammation markers, stress and~     psychological variables in patients with irritable bowel syndrome and inflammatory bowel~     disease undergoing gut-directed hypnotherapy (GHT).~   "
78752|NCT02536118|"~     Medtronic is sponsoring the Micra Registry to further confirm safety and effectiveness of the~     Micra Transcatheter Pacing System (Micra system) when used as intended, in real-world~     clinical practice, following commercial release.~      The Micra Registry is conducted within Medtronic's Product Surveillance Registry.~   "
78753|NCT02536105|"~     The purpose of this study is to evaluate the association between blood drug levels and the~     corresponding scores of commonly used behavioral instruments based upon data collected~     following administration of three different methylphenidate hydrochloride extended-release~     drug products in children with ADHD.~   "
78754|NCT02536092|"~     To evaluate the safety and efficacy of the Cutera excel HR dual wavelength 755nm Alexandrite~     and 1064nm Nd:YAG laser for hair removal.~   "
78755|NCT02536079|"~     The NeST registry is a pro-active industry-academic collaboration to assess the use and~     safety of NeuroAiD in the real world setting. An online entry system was set up to allow easy~     data entry and retrieval of clinical information.~   "
78756|NCT02536066|"~     The postprandial blood glucose concentration is an important risk factor for development of~     cardiovascular diseases and diabetes. Previous studies have shown that one bout of moderate~     or light post-meal physical activity effectively blunts the postprandial increase in blood~     glucose after carbohydrate intake. Pre-meal exercise does not generate such effect. Thus, the~     effect of exercise on postprandial glycemia depend on the timing of exercise. Even very light~     physical activity decreases postprandial glycemia when performed in the postprandial period.~     The purpose of this study was to investigate whether such activity performed each day for 12~     weeks would influence blood variables related to glycemic control.~      METHODS 40 subjects being ethnic Norwegians or of South Asian origin were randomized into an~     intervention or a control group. They were previously diagnosed as hyperglycemic, or with~     high risk of type 2 diabetes according to Ramachandran's risc score.~      Control subjects were told to maintain their usual physical activity patterns during the~     study period, while the intervention subjects were instructed to undertake a minimum of 30~     minutes of daily post-meal physical activity in addition to their usual activity patterns.~      Venous blood samples were taken before and after the 12 week intervention period. Plasma was~     analyzed for HbA1c and for fasting and 2hour (OGTT) values of glucose, insulin and c-peptide.~     The subjects kept a physical activity diary, answered questionnaires and used accelerometers~     to determine the level of physical activity.~   "
78757|NCT02536053|"~     This study aims to:~        1. validate the Finnish version of the Musculoskeletal Tumor Society scale and the Toronto~          Extremity Salvage Score lower extremity sections and to~        2. assess the functional ability and health-related quality of life (HRQoL) of lower~          extremity sarcoma patients who have undergone limb salvage surgery.~   "
78758|NCT02536040|"~     This study is being conducted to test whether the use of diammine silver fluoride (also~     called silver diamine fluoride) hardens the cavity sufficiently so that it arrests.~   "
78759|NCT02536027|"~     The plasma level of neutrophil gelatinase-associated lipocalin (NGAL) in critically ill~     patients with AKI is not affected by continuous venovenous hemofiltration (CVVH). However, it~     remains unclear if this also applies to sepsis-induced AKI, as considerable evidence suggests~     that the pathophysiology of septic AKI is different from other causes of AKI.~   "
78760|NCT02536014|"~     Sympathetic activity could be increased during robot-assisted laparoscopic radical~     prostatectomy, which is performed in a steep trendelenburg position under CO2~     pneumoperitoneum.~      Stimulation of the sympathetic nervous system prolongs the QT interval and can increases the~     susceptibility to life threatening cardiac arrhythmias.~      Dexmedetomidine has sympatholytic effects and potential antiarrhythmic properties.~     Perioperative administration of dexmedetomidine is a potential preventive and treatment~     strategy for tachyarrhythmia. Thus the investigators decided to evaluate the effect of~     dexmedetomidine on heart-rate corrected QT interval during robot-assisted laparoscopic~     radical prostatectomy. Furthermore, the investigators evaluated the Tp-e, Tp-e/QT ratio and~     Tp-e/QTc ratio as well.~   "
78761|NCT02536001|"~     The purpose of this study is to compare anatomical differences, quality of life and sexual~     function and complications rate between apical support with one anterior vaginal mesh versus~     repair with two separate meshes.~   "
78762|NCT02535988|"~     Patients with colorectal cancer that had metastatic lesions after been treated with~     definitive surgery or chemoradiotherapy are being asked to participate in this study.~        1. To observe immunity-mediated tumor response outside the radiation field (abscopal~          effect) after chemoradiotherapy of a metastatic site in metastatic colorectal cancer~          patients.~        2. To induce the efficacy (effectiveness) of a new combination of therapy,~          chemoradiotherapy and thymalfasin for heavily pretreated, metastatic esophageal cancer~          patients;~        3. To explore the role of PET/CT scanning to assess tumor response/abscopal effect.~      This study will help find out what abscopal effects (good or bad) the combination of~     radiotherapy and thymalfasin has on metastatic esophageal cancer.~   "
78763|NCT02535975|"~     This is a prospective, randomized, double-blind, placebo-controlled study about the effect of~     metformin in patients with mild Graves' ophthalmopathy. Eighty patients with mild~     ophthalmopathy will be included. Each patient will be given either metformin (500mg PO three~     times a day) or placebo ( PO three times a day ) for 6 months and then followed for 6 months~     after withdrawal of treatment.~   "
78764|NCT02535962|"~     The purpose of study is to see if adding probiotics to corticosteroid treatment for children~     with PFAPA could improve the health and daily of patients through reduction in febrile period~     frequency and length, along with concomitant reduction of associated symptoms. Current~     standard of care incorporates the administration of corticosteroids; however, while limiting~     the symptoms associated with PFAPA, corticosteroid use has been shown to increase the~     frequency at which these symptoms occur. Investigators hypothesize that administration of~     probiotics along with corticosteroids will work to decrease the frequency at which the~     febrile episodes occur. Additionally, probiotics may decrease the maximal fever experienced~     during these episodes, amount of corticosteroid needed to control the symptoms, average~     length of the episodes, and the number of patients who ultimately undergo tonsillectomy due~     to unsuccessful treatment with medication.~   "
78765|NCT02535949|"~     The purpose of this study is to evaluate the effects of TXA on the immune system, its~     pharmacokinetics, as well as safety and efficacy in severely injured trauma patients.~   "
78766|NCT02535936|"~     The purpose of this study is to characterize the cortical connectivity changes in the brain~     of spastic diplegic children after Selective Dorsal Rhizotomy.~   "
78767|NCT02535923|"~     The goal of this project is to develop guidelines for the clinical tailoring of Cognitive~     Behavioral Therapy for Insomnia (CBT-I) for Veterans with psychotic disorders and insomnia,~     and to test the acceptability, feasibility, and preliminary efficacy of CBT-I for improving~     sleep-related functional outcomes in this population.~   "
78768|NCT02535910|"~     This study aims to compare the acute effect of consuming milk and butter fortified with~     either vitamin D3 or 25 (OH) D3 on serum/plasma vitamin D status in humans. In addition, the~     effect of vitamin D3 or 25 (OH) D3 in milk and butter on certain CVD risk markers and~     cognitive function will be examined.~   "
78769|NCT02535897|"~     The purpose of this study is to assess the effects of a protein-carbohydrate beverage on the~     absorption of an orally ingested bolus of L-carnitine, compared to flavoured water and~     carbohydrate-only controls, and to determine whether increasing plasma carnitine availability~     can impact upon insulin-stimulated muscle carnitine uptake.~   "
78770|NCT02535884|"~     The aim of the study is to prove the efficacy and safety of pallidal DBS in HD patients and~     to show superiority of DBS on motor function in the stimulation group compared to~     stimulation-off group~   "
78771|NCT02535871|"~     The primary objective of this study is to compare the efficacy, safety and tolerability of~     IDP-121 Lotion and vehicle in the treatment of subjects with acne vulgaris.~   "
78772|NCT02535858|"~     Anxiety is one of the major influences on relapse and substance abuse treatment dropout.~     Chemically dependent individuals need to be aware of their emotional state in situations that~     jeopardise their treatment. The current therapeutic resources still subjective and with~     limited treatment success. This research presents a developed virtual environment (VE)~     simultaneously connected to a physiological signals device acquisition that allows, through a~     biofeedback, the chemically dependents consciousness on their vulnerability front different~     situations of 'risk', without a direct assessment of the therapist. Developed in 3ds Max®~     software, the VE is composed of scenarios and objects that are in the habit of the chemically~     dependent individual's daily life. The interaction with the environment is accomplished using~     a Human-Computer Interface (HCI) that converts incoming physiological signals indicating~     anxiety state into commands that change the scenes. Anxiety is characterized by the average~     variability from both heart and respiratory rate of 30 volunteers undergoing stress~     environment situations. To evaluate the effectiveness of the VE as a biofeedback of~     chemically dependent's vulnerability front situations of risk, a total of 50 volunteers who~     were drug users, monitored by 10 therapists, were enrolled. Prior VE, the results~     demonstrated a poor correlation between the therapists' predictions and those of the~     chemically dependent individuals. After exposure to the VE, there was a significant increase~     of 73% in awareness of the risks of relapse by the chemically dependent individuals,~     confirming the hypothesis that the VE coupled to the biofeedback device may assist the~     therapist with treatment.~   "
78773|NCT02535845|"~     HPV vaccine coverage among adolescents in the US is suboptimal. This is particularly true~     among traditionally underserved adolescents. Few parent-targeted interventions have focused~     on the parental decision-making process. Self-persuasion, generating one's own arguments for~     engaging in a behavior, may be an effective means to influence parents' motivation to~     vaccinate their children. In a three-phase study, investigators are using quantitative and~     qualitative research methods to develop and refine a tablet-based self-persuasion~     intervention for parents who are undecided about the HPV vaccine. This clinical trial~     submission focuses on the third phase of the study (the second stage is also registered in~     clinical trials).~   "
78774|NCT02535832|"~     Muscle strength helps determine a person's quality of life and functional independence.~     Patients with rheumatoid arthritis often suffer from muscle weakness and a pre-diabetic~     condition called insulin resistance.~      By doing this study, the investigators hope to learn why patients with rheumatoid arthritis~     (RA) suffer from muscle weakness.~   "
78829|NCT02535104|"~     Ranpirnase in topical formulation is an antiviral drug being evaluated for the topical~     treatment of anogenital warts. The aims of this study is to evaluate the efficacy and safety~     of a topical formulation of ranpirnase in subjects with genital warts.~   "
78775|NCT02535819|"~     Cataract is the clouding of the lens of the eye, which initially prevents clear vision and~     eventually progresses to blindness if left untreated. Cataract remains the leading cause of~     blindness and an important cause of visual impairment across the globe. Cataract surgery by~     ultrasonic phacoemulsification is the most common surgery practiced in France (600 000/year)~      Two sub-categories of phacoemulsification coexist :~      Endocapsulars techniques represented by Divide-and-Conquer and Phaco-Chop ; and Supracapsular~     techniques mainly represented by Subluxation (similar to Tilt-and-Tumble) The corneal~     endothelium plays an important role in maintaining the dehydrated state and the transparency~     of the cornea. Some degree of endothelial cell loss invariably occurs in all types of~     cataract surgery but the amount of endothelial cell loss may varies with the type of surgical~     technique The aim of the study is to evaluate the density of the central corneal endothelial~     cells before and after cataract surgery comparing two phacoemulsification techniques~     (Divide-and-Conquer vs Subluxation)~   "
78776|NCT02535806|"~     This is a phase II study designed to investigate the combination of bortezomib with the~     mitoxantrone reinduction regimen used in the ALL R3 trial. The study will enroll patients~     with high risk ALL relapse including early bone marrow relapse and second or greater relapse~     of any kind. Patients with relapsed LL will also be eligible. Bone marrow evaluation will be~     performed after blood counts recover to assess the rate of CR (<5% bone marrow blasts) and~     MRD status in children following this regimen. Further treatment with or without HSCT will be~     at the discretion of the primary physician.~   "
78777|NCT02535793|"~     Allergy is a very common problem and can be a handicap in everyday life, specially when~     symptoms occur at work place. Some persons working with drosophila developed respiratory~     symptoms. Investigators tried to analyze if these manifestations could be due to a specific~     allergy to drosophila.~   "
78778|NCT02535780|"~     The primary aim of this study is to study how Repetitive Transcranial Magnetic Stimulation~     (rTMS) tailored to specific anorexia nervosa (AN) or bulimia nervosa (BN) brain activation~     alterations will promote recovery and to study how inhibitory tDCS (Transcranial Direct~     Current Stimulation) will reduce symptoms of body image distortion in a second sample of AN~     and BN groups.~   "
78779|NCT02535767|"~     The purpose of this study is to determine the highest tolerable dose of primaquine within~     0.75 mg/kg. A tolerable dose is defined as one in which:~        -  Two or fewer participants (< 30%) experience hemolysis;~        -  No participant experiences a drug-related serious adverse event; and~        -  No participant requires a blood transfusion.~   "
78780|NCT02535754|"~     Behaviour changes such as improving nutrition, increasing physical activity, and decreasing~     obesity are linked with lower mortality and morbidity and fewer cancers. Health promotion~     programs in the workplace are a promising way to reach a large segment of the population.~     This project evaluated the efficacy of three approaches - all of which were based on previous~     research and programs with demonstrated positive benefits - on cancer-related outcomes~     (healthy eating, physical activity, normal body weight) and work-related outcomes~     (absenteeism, presenteeism).~   "
78781|NCT02535741|"~     An open label, post-market, non-randomised, historical controlled, multi-centre study of the~     outcomes of the Triathlon Cruciate Retaining (CR) Total Knee System.~   "
78782|NCT02535728|"~     A prospective observational cohort study to assess the predictive value of preoperative~     frailty on postoperative quality of life in cardiac surgery patients.~   "
78783|NCT02535715|"~     ORAMED has developed an oral insulin that, in preliminary studies, has shown promise. In the~     present study investigators will perform a pharmacodynamic/pharmacokinetic study to evaluate~     this novel insulin preparation as a potential therapeutic option in diabetic patients.~   "
78784|NCT02535702|"~     Background:~      Abusing alcohol, drugs, and other substances can cause serious health problems. These~     substances also can affect brain function. Researchers want to learn more about brain~     function by using magnetic resonance imaging (MRI). This uses a magnetic field and radio~     waves to take pictures of the brain.~      Objective:~      To develop new ways to use MRI to study the brain.~      Eligibility:~      Healthy people 18 years of age or older.~      Design:~      Participants will be screened with a medical history, physical exam, and blood and urine~     tests.~      They will answer questions about their drug use and psychiatric history. They will be asked~     about family history of alcoholism or drug abuse.~      Participants will answer questions to see if they can participate in MRI.~      Participants will have MRI scans. The scanner is a metal cylinder in a strong magnetic field.~     Participants will lie on a table that slides in and out of the cylinder. A device called a~     coil may be placed over the head.~      Each sub-study will include up to 3 different MRI visits. Participants can be in multiple~     sub-studies. But they can have only 1 MRI per week and 20 per year.~      During MRI visits, participants may have urine collected. They may get another MRI~     questionnaire.~      Participants may have a clinical MRI brain scan. This may show physical problems in the~     brain.~      During some scans, participants may perform simple movement, memory, and thinking tasks.~      Participants may be connected to a machine to monitor brain activity during the scan. Small~     metal electrodes will be placed on the scalp. A gel will be placed in the space between the~     electrodes and the scalp.~   "
78794|NCT02535572|"~     This open label investigation further evaluates the safety, efficacy and potential mechanisms~     of action of a new form of electroconvulsive therapy (ECT). The investigators have recently~     completed preliminary open-label studies with FEAST, first at Columbia University, and then~     at the Medical University of South Carolina in Charleston (Nahas et al., 2013b). The~     investigators have published the outcomes of the first 17 patients studied. One patient~     withdrew from the study after a single titration session. After the course of FEAST (median~     10 sessions), there was a 46.1 + 35.5% improvement in Hamilton Rating Scale for Depression~     (HRSD24) scores compared to baseline (33.1 + 6.8, 16.8 + 10.9; P < 0.0001). Eight of 16~     patients met response criteria (≥50% decrease in HRSD24) and 5/16 met remission criteria~     (HRSD24≤10). Patients achieved full re-orientation (4 of 5 items correct) in 5.5 + 6.4 min~     (median time = 3.6 min), timed from when their eyes first opened after treatment. The~     investigators have now studied 18 more patients (see results below), and we are completing~     the study in the original IDE with another two more patients still to enroll.~      This work allowed us to refine the treatment. For example, the investigators selectively~     modified the electrode geometry to decrease interelectrode resistance. Additionally the~     investigators modified the titration schedule, now only administering a standard 800 ma~     ultrabrief pulse, and thus no longer titrating in the current domain.~      In this next proposed trial we will continue to gather efficacy and safety data, and compare~     these to a parallel non-randomized group receiving ECT standard of care.~      ECT is typically delivered in a dynamically adaptive manner, with each person having a~     different number of treatments, averaging between 8-12 treatment over 4-5 weeks. We thus have~     to use imprecise time points such as 'at the end of the acute treatment course' rather than~     specified dates or visits.~   "
78785|NCT02535689|"~     Background:~      Systemic lupus erythematosus (lupus) is an autoimmune disease that often involves many~     systems and organs of the body. Symptoms can include fever, joint pains, and rashes. Serious~     lupus can also damage organs like the kidneys, lungs, or brain. Drugs used for lupus can have~     serious side effects. Also, the drugs don t help some people. Researchers want to find new,~     more effective and safe treatments.~      Objective:~      To evaluate the safety and tolerability of the drug tofacitinib (study drug) in people with~     lupus.~      Eligibility:~      People ages 18 and older who have mild to moderate lupus and are not currently or haven t~     recently had certain lupus treatments.~      Design:~      Participants will be screened in another protocol.~      Participants will have 7 five-hour visits over about 3 months. They will fill out multiple~     questionnaires. They will have tests, including:~        -  Physical exam~        -  Blood and urine tests~        -  ECG/EKG: Soft electrodes are stuck to the skin to monitor the heart.~        -  Optional SphygmoCor: Cuffs are attached to the arm and thigh to measure blood pressure~          and flow speed.~        -  Optional Endopat: A thimble-shaped cup is placed on the finger to measure blood flow. A~          cuff is put on the arm to measure blood pressure and flow.~        -  Optional CAVI: ECG electrodes are placed on both wrists, a microphone placed on the~          chest, and a blood pressure cuff placed on each arm and leg to measure blood pressure~          and velocity.~      Participants will receive either the study drug or a placebo. They will take this twice a day~     by mouth for 56 days.~      Participants will be contacted by phone 4 times....~   "
78786|NCT02535676|"~     The aim of this study is to evaluate the therapeutic efficacy of tDCS (transcranial direct~     current stimulation) for treatment of negative symptoms in patients with schizophrenia. The~     proposed design is a clinical trial, randomized, double-blind, placebo-controlled study.~     Participants will receive ten sessions of active or sham stimulation in five consecutive~     days. 100 patients will be randomized into two groups (active tDCS vs sham tDCS) and will be~     assessed after the intervention: 2, 4, 6 and 12 weeks after. As objectives, the investigators~     expect to see a clinical improvement of negative symptoms through scales PANSS (Positive and~     Negative Syndrome Scale), Calgary, Auditory verbal hallucinations, SANS (Skills for~     Assessment of Negative Symptoms), and expect improvement on computerized cognitive tests.~     Another goal is to see improvement in biological markers related to schizophrenia, plasma and~     DNA will be stored.~   "
78787|NCT02535663|"~     To investigate the impact of consumption of dairy yogurt with rhamnogalacturonan (RG) in~     Korean citrus Hallabong peel polysaccharide on Natural Killer (NK) cell activity and~     circulating cytokine levels.~   "
78788|NCT02535650|"~     Platinum-based chemotherapy is now regarded a standard first-line treatment for patients with~     advanced urothelial carcinoma (UC). However, patients who failed to response or experienced~     progression after platinum-based chemotherapy have a grim prognosis and a standard salvage~     treatment is not available.~      UC is known to harbor multiple mutations. In the investigators' own high-throughput molecular~     profiling study, the most commonly observed mutations included TP53, FGFR3(fibroblast growth~     factor receptor 3 ) and HRAS. Since RAS signaling can be attenuated using selective farnesyl~     transferase (FTase) inhibitors, tipifarnib, a highly potent and selective inhibitor of FTase,~     was proposed to be an effective therapeutic approach in the treatment of UC.~   "
78789|NCT02535637|"~     The purpose of this study is to explore the effect maternal obesity and breastfeeding play on~     infant body composition. The investigators hypothesize in the first 6 months of life breast~     fed offspring from overweight / obese mothers will be fatter with greater trunk fat mass and~     accumulate fat at a greater rate than breast fed infants from normal weight mothers.~     Furthermore, the investigators postulate that circulating maternal milk adipocytokines will~     positively correlate to total fat mass at six months of age.~   "
78790|NCT02535624|"~     This study is designed to answer whether minimal invasive vessel clotting (angioembolization)~     or open surgery (retroperitoneal packing) is more effective for pelvic fractures with massive~     bleeding. Patients admitted at daytime (7am-5pm) are treated with angioembolization while~     patients admitted at nighttime (5pm to 7am) are treated with open surgery.~   "
78791|NCT02535611|"~     The researchers aim to investigate the effect of memantine on stroke outcome in a randomized~     double-blind placebo-controlled clinical trial.~   "
78792|NCT02535598|"~     This project aims to investigate factors that are important in affecting adherence in~     internet based Cognitive Behavior Therapy (CBT). It is hypothesized that two~     intervention-specific variables, Support and Content, are important factors and that~     maximizing the impact of these would result in improved adherence and potentially in the end~     also better outcome for participants in internet interventions.~   "
78793|NCT02535585|"~     The shoulder is the joint that most commonly suffers dislocation, and anterior instability is~     the most frequent form. Arthroscopic repair is the gold standard for the treatment of~     recurrent shoulder dislocation. The most commonly used technique is the attachment of glenoid~     labrum-ligament complex (GLLC) with knotted anchors. In 2001, Thal introduced the concept of~     tissue fixation using knotless anchors and its applicability for GLLC lesions. Some~     researchers have published studies using knotless anchors and have compared this technique to~     the use of knotted anchors, demonstrating similar reconstruction of labral height and~     functional outcomes, while the recurrence rate is still contradictory. To date, there are no~     prospective randomized controlled clinical trial comparing these two techniques of GLLC~     repairs.~      The researchers aims to compare clinical outcomes and imaging evaluation of patients~     undergoing GLLC repair arthroscopically with the use of absorbable knotless and knotted~     anchors.~   "
78795|NCT02535559|"~     This study evaluates the efficacy of Teens Against Tobacco Use anti-tobacco presentations on~     tobacco use susceptibility in 4th-8th grade. Classrooms are randomly assigned to either~     receive a series of two presentations or wait listed to receive them later in the school~     year.~   "
78796|NCT02535546|"~     Patients suffering from chronic obstructive pulmonary disease (COPD) commonly get~     exacerbations of their illness which have many potential triggers including infection. The~     most common cause of lung infection/pneumonia is an organism named Streptococcus pneumoniae.~     In Ireland a 13-valent pneumococcal conjugated vaccine (PCV-13) was recently introduced into~     the childhood vaccination programme. This study aims to investigate the carriage rate of S.~     pneumoniae in COPD patients over one year and to determine if isolates of S. pneumoniae found~     within the COPD population would be covered by the PCV-13 vaccine.~   "
78798|NCT02535520|"~     Optovue has implemented a motion contrast imaging software in RTVue XR, a split spectrum~     amplitude decorrelation algorithm (SSADA), for non-invasive imaging of ocular vasculature.~     Consented subjects will undergo a series of images of the back of the eye using an Optical~     Coherence Tomograpy (OCT) device, RTVue XR, in addition to the conventional images as part of~     clinical routine. SSADA images will be compared with conventional methods.~   "
78799|NCT02535507|"~     Various driver gene mutations have been identified in lung cancer. Among them, human~     epidermal growth factor 2 (HER2) was identified in about approximately 2% of non-small cell~     lung cancers.Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2~     receptors. This study is designed to evaluate the efficacy and safety of Pyrotinib in~     patients with HER2 positive advanced Non-small cell lung cancer.~   "
78800|NCT02535494|"~     This investigation is one of the first large-scale, prospective attempts to obtain data on~     the effectiveness of naloxone distribution among opioid-abusing populations at high risk of~     unintentional opioid poisoning. Specifically, opioid abusers will be recruited from drug~     detoxification sites as well as those accessing services at needle exchange programs. All~     participants (N=700) will receive the standard opioid overdose education and naloxone. One~     third of the participants will be randomized to receive additional in-depth psychosocial~     education focusing on recognition and prevention of opioid overdose, and appropriate use of~     naloxone. Another third of the participants will receive the extensive training and be~     required to engage a spouse, partner, relative, or friend in this supplementary intervention.~     The investigators plan to randomize individuals to each group [Treatment as Usual (TAU) vs.~     Extensively Trained (ET) vs. Extensively Trained with a Significant Other (ETwSO)] and,~     through continued follow up over one year, the investigators will compare self-reported~     overdose reversal attempts (with and without naloxone use), naloxone-related adverse events,~     and changes in patterns of heroin and other drug use.~   "
78801|NCT02535481|"~     Split thickness skin grafting is the normal standard of care for wound closure. However, this~     is an invasive procedure and associated with pain also there can be additional donor site~     morbidity. Epidermal grafting is an emerging clinical alternative that is gaining clinical~     practise. Epidermal grafting (EG) is an alternative method of autologous skin grafting that~     'harvests' a finer layer of skin than traditional Split thickness skin grafting (SSG). This~     potentially results in less pain and reduced donor site morbidity but only delivers several~     cell layers to the wound so may be less effective at healing a wound. It is not known if EG~     is an effective alternative to SSG.~      Further the mechanism to achieve wound healing may be different. EG promotes wound healing by~     expressing growth factors that accelerates wound healing and encourages keratinocyte~     migration. Whereas SSG is a transplant of several skin layers that integrated to the existing~     wound bed as a formal skin covering.~      The investigators wish to compare these two clinical practises; epidermal grafting and split~     thickness skin grafting in wound healing. Further to undertake a translational study to~     investigate the mechanism by which each technique achieves wound healing.~   "
78802|NCT02535468|"~     The purpose of this study is to demonstrate the safety and effectiveness of the T2Bacteria~     Panel by validating the clinical performance (i.e. estimated sensitivity and specificity) of~     the T2Bacteria Panel compared to blood culture results and/or known Bacteria positive status~     of prospectively collected clinical specimens and contrived (i.e. Bacteria-spiked) whole~     blood clinical samples.~   "
78803|NCT02535455|"~     Innovative approaches are needed to optimize the benefits of treatment as prevention (TasP)~     among HIV+ substance users, who experience profound health disparities that amplify onward~     transmission risk. This project will systematically develop, refine and conduct an open pilot~     to assess the feasibility and acceptability of a two-phase emotion regulation intervention~     that targets emotional barriers to HIV-related self-care among individuals who endorse active~     substance use. Emotional barriers such as shame and internalized stigma have been identified~     as barriers to optimal HIV care among individuals struggling with HIV and substance use. To~     effectively implement TasP, strategies for addressing these barriers are needed. Utilizing~     transdiagnostic approaches (e.g., positive affect-focused emotional regulation, mindfulness~     and self-compassion) investigators will develop, refine and pilot a two-phase emotional~     regulation intervention that requires only 5 face-to-face hours and can ultimately be~     implemented by a case-management-level staff person or trained peer educator. The first phase~     of the intervention will be a multicomponent in-person intervention targeting emotional,~     cognitive and behavioral barriers to HIV self-care behaviors among HIV+ substance users. The~     second phase of the intervention will extend the intervention benefits by sending~     personalized positive self-reappraisal text messages in response to text message queries~     about participants' mood. This phase will use an innovative personalized bi-directional~     platform, which will leverage an existing text message delivery system. This project will be~     instrumental in developing a relatively low-resource intervention strategy to address unmet~     emotional barriers to optimal HIV-care among individuals who are actively using substances.~     This work will provide the necessary pilot data for a subsequent grant submission to assess~     the preliminary efficacy of the intervention. The resulting intervention has the potential to~     address emotional barriers to self-care along the HIV care cascade: including retention in~     care, antiretroviral treatment adherence and persistence, and ultimately viral suppression.~   "
78804|NCT02535442|"~     The objective of this study is to evaluate the microbial consortia and the host inflammatory~     factors present in the nasal passages of patients during upper respiratory symptomology and~     when healthy using culture and molecular analysis techniques.~   "
78805|NCT02535429|"~     Massage therapy during 1 month and evaluation of depression, hyperventilation, anxiety and~     quality of life~   "
78806|NCT02535416|"~     Single doses of ARC-520 will be evaluated at varying infusion rates and by slow bolus push.~   "
78807|NCT02535403|"~     Cognitive behavioral therapy (CBT) is a well-documented and effective method for the~     treatment of children and adolescents with anxiety disorders. Lately there has been an~     increase in the development and use of internet-based CBT programs (ICBT), as a means to~     reduce costs and enhance accessibility of psychological interventions. ICBT has proven~     efficacious towards adults with anxiety disorders. Research in the field of ICBT with~     children and adolescents is still in its infancy though and to date, no program targeting~     anxiety disorders has been developed nor evaluated in Denmark. The primary objective of this~     study is to investigate the efficacy of a newly developed internet-based treatment program~     for adolescents with anxiety disorders. The effect will be examined in a randomized~     controlled trial comparing ICBT to a wait-list control condition.~   "
78830|NCT02535091|"~     This is a multicenter, open label study to assess the safety and pharmacokinetics of YKP3089~     as adjunctive therapy in subjects with partial onset seizures. Initially, subjects taking~     phenytoin or phenobarbital will be enrolled followed by additional subjects taking~     anti-epileptic drugs other than phenytoin and phenobarbital to further investigate long-term~     safety.~   "
81875|NCT02495259|"~     The purpose of this study is to compare three different standard of care methods of~     double-lumen endobronchial tube (DLT) placement in patients who are scheduled to have~     thoracic surgery in which lung isolation is required.~   "
78808|NCT02535390|"~     Major depressive disorder places a tremendous burden on workplace disability each year. Its~     diagnosis is based on the presence of characteristic symptoms that include disturbances in~     mood regulation, maladaptive beliefs, and behaviour. Impairment in neurocognitive functions~     (e.g., information processing speed, attention, memory, problem solving skills) is absent~     from current diagnostic criteria and off the radar in most clinical treatment settings, yet~     increasingly recognized as a primary cause of poor work functioning and outcomes. This~     disconnect between the root causes of poor vocational outcomes and targets of treatment has~     resulted in a failure to return to work following illness, job underproductivity, and~     work-related stress, which contribute to indirect costs to society each year. The~     investigators seek to expand scientific support for treating neurocognitive impairments in~     order to increase occupational productivity and reduce job-related stress associated with~     depression. The investigators developed a novel group cognitive remediation (CR) treatment,~     Action-Based Cognitive Remediation (ABCR). It builds on procedural learning skills with~     explicit work-related role-plays to facilitate immediate and salient abstraction of drill and~     practice remediation techniques. The activities were developed in collaboration with a~     community rehabilitation partner in this study through systematic interviews with job~     placement specialists and supervisors from employment sites used by the agency. The props~     match those used in work settings and include miniature versions of a cash register, filing~     system, conveyer belt, cleaning closet, garden nursery, and secretarial station. The~     activities capitalize on procedural learning skills through roleplays and props that simulate~     a work environment. ABCR maintains important aspects of drill and practice, strategic~     monitoring to enhance flexible problem solving approaches, and bridging. The role-plays~     follow computerized drill and practice exercise and therapists facilitate group discussions~     of how cognitive skills and flexibility in thinking from drill and practice can be effective~     while directly engaged in an everyday work environment. Thus, bridging used in ABCR is a~     tangible, procedural, and realistic. This approach to bridging differentiates the treatment~     from standard CR, where the discussion-based approach is limited by the auditory learning,~     memory, and abstraction deficits observed in depression.~   "
78809|NCT02535377|"~     Sperm freezing has been employed for decades for male fertility preservation in cases of~     foreseeable or unexpected loss of fertility to guarantee future paternity, and also as a~     complement of assisted reproduction techniques.~      Sperm quality after thawing is highly variable, even among consecutive samples from the same~     individual, with mean survival rates around 40%. To date, the molecular basis of the adequate~     resistance or intolerance to freezing/thawing protocols is unknown, and its knowledge can~     lead to improvement in the selection of the samples to be frozen and also in the adequate~     supplement of cryopreservation media. Microarray analysis provides a powerful tool to address~     the molecular explanation beyond this behaviour, yielding results about comparative messenger~     ribonucleic acid (mRNA)expression under the two different biological conditions: optimal and~     suboptimal survival.~      Then, the aim of the investigators' study is to determine the genomic profile of sperm~     samples depending on their survival resistance to cryopreservation, to determine genes~     involved in cryodamage sensitivity.~   "
78810|NCT02535364|"~     This single-arm, multicenter Phase 2 trial will treat adult patients who have relapsed or~     refractory B-ALL with an infusion of the patient's own T cells that have been genetically~     modified to express a chimeric antigen receptor (CAR) that will bind to leukemia cells that~     express the CD19 protein on the cell surface. The study will determine if these modified T~     cells (called JCAR015) help the body's immune system eliminate leukemia cells. The trial will~     also study the safety of treatment with JCAR015, how long JCAR015 cells stay in the patient's~     body, the extent to which JCAR015 eliminates minimal residual disease, and the impact of this~     treatment on survival.~   "
78811|NCT02535351|"~     Two randomized trials in the cytokine era clearly showed that cytoreductive nephrectomy (CN)~     had a role in metastatic renal cell carcinoma (mRCC) increasing life expectancy. The survival~     benefit of tyrosine kinase inhibitors (TKIs) including first-line sunitinib and pazopanib in~     mRCC has been demonstrated, but the majority of patients enrolled in the pivotal phase III~     studies had undergone nephrectomy.~      Therefore it is unknown if similar survival benefit could be achieved without CN with these~     new targeted agents.~      At the same time there is a need to better understand mechanisms of primary and secondary~     resistance to TKIs in mRCC patients and to identify eighter prognostic and predictive~     biomarkers to better define risk factors and potentially druggable targets.~   "
78812|NCT02535338|"~     This phase I/II trial studies the side effects and best dose of onalespib lactate when given~     together with erlotinib hydrochloride and to see how well they work in treating patients with~     EGFR-mutant non-small cell lung cancer that has come back (recurrent) or has spread to other~     places in the body (metastatic). Erlotinib hydrochloride and onalespib lactate may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
78813|NCT02535325|"~     This phase I trial studies the side effects and best dose of methoxyamine when given together~     with pemetrexed disodium, cisplatin, and radiation therapy in treating patients with stage~     IIIA-IV non-small cell lung cancer. Drugs used in chemotherapy, such as methoxyamine,~     pemetrexed disodium, and cisplatin, work in different ways to stop the growth of tumor cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors.~     Giving methoxyamine together with pemetrexed disodium, cisplatin, and radiation therapy may~     kill more tumor cells.~   "
78814|NCT02535312|"~     This phase I/II trial studies the side effects and the best dose of methoxyamine when given~     together with cisplatin and pemetrexed disodium and to see how well it works in treating~     patients with solid tumors or mesothelioma that have spread to other places in the body and~     usually cannot be cured or controlled with standard treatment (advanced), or mesothelioma~     that does not respond to pemetrexed disodium and cisplatin or carboplatin (refractory).~     Methoxyamine may shrink the tumor and may also help cisplatin and pemetrexed disodium work~     better by making tumor cells more sensitive to the drugs. Drugs used in chemotherapy, such as~     cisplatin and pemetrexed disodium, work in different ways to stop the growth of tumor cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Giving methoxyamine together with cisplatin and pemetrexed disodium may be a~     better treatment for solid tumors or mesothelioma.~   "
78815|NCT02535299|"~     Objectives: To investigate the treatment effect between insulin,metformin and Liraglutide; in~     Type 2 Diabetes in our hospital, in order to investigate the possible mechanism about~     telomere-telomerase system and Par-4.~   "
78816|NCT02535286|"~     The purpose of this study is to evaluate the safety and effectiveness of pembrolizumab in~     combination with ublituximab and TGR-1202, in patients with advanced CLL or Richter's~     Transformation.~   "
78817|NCT02535273|"~     Evaluate safety and efficacy of dexmedetomidine in minimally invasive spine surgery under~     local anesthesia sedation.Explore the appropriate concentration of dexmedetomidine, whether~     or not can reduce the amount of local anesthetics.~   "
78819|NCT02535247|"~     This is a multicenter, single-arm, open label 2-stage phase 2 study exploring monotherapy~     with the PD-1 antibody pembrolizumab (or MK-3475) given intravenously at a fixed dose of~     200mg every 3 weeks for up to 36 cycles for patients with relapsed or refractory Peripheral~     T-cell Lymphoma (PTCL), who have received at least 1 prior systemic therapy. The primary~     endpoint of the study is progression-free survival. Secondary outcomes are overall survival~     and response rate. Patients will be assessed for response with PET CT or CT every 12 weeks~     using the revised Cheson criteria. Correlative endpoints will be exploratory and assess PD-1~     expression on peripheral blood lymphocytes; peripheral blood T-cell and NK-cell functional~     assays; PD-1 and PD-L1 expression on tumor tissue; and tumor infiltrating lymphocytes as~     prognostic and predictive biomarkers.~   "
78820|NCT02535221|"~     This study proposes to prove that the efficacy of adjuvant endocrine therapy for the~     premenopausal HR positive breast cancer patients is non-inferiority to adjuvant chemotherapy~     assessed by ultrasound response rate.~   "
78821|NCT02535208|"~     The primary aim of this study is to determine the mean number of red blood cell (RBC)~     transfusions received by preterm infants cared for using restrictive Hgb guidelines in~     combination with splanchnic to cerebral oxygenation ratio (SCOR) assessment compared to the~     mean number of transfusions received by preterm infants cared for using liberal guidelines~     alone.~      This study is designed as a prospective randomized controlled trial. Preterm infants less~     than 30 weeks gestational age and 500-1250 grams in weight will be recruited and enrolled~     into the study during day of life 0 to 3. Study participants will be randomly assigned into~     two groups: a restrictive transfusion group and a liberal transfusion group. In the liberal~     group, RBC transfusions will be given to subjects when their Hgb level falls below defined~     values that are based on respiratory support status. In the restrictive group, RBC~     transfusions will be given to subjects either when their Hgb level falls below defined values~     based on respiratory status or, despite not having reached their Hgb trigger threshold, if~     they manifest symptoms judged by the clinical care team to be consistent with anemia (i.e.~     apnea, bradycardia, or desaturation episodes) and subsequently have a near-infrared~     spectroscopy (NIRS) evaluation that demonstrates an SCOR < 0.73.~   "
78822|NCT02535195|"~     The hypothesis of this study was that ginger supplement consumption can be introduced as a~     new therapeutic strategy for non-alcoholic fatty liver disease through the improved body~     antioxidant activity, reduced levels of inflammation and insulin resistance. A randomized~     double-blind study was designed to evaluate this hypothesis in order to examine the~     effectiveness of ginger supplement in patients with non-alcoholic fatty liver disease.~   "
78823|NCT02535182|"~     This is a an ancillary study designed to explore whether an additional cell signaling pathway~     (prenylation of Rap1) that was recently identified as being under beta-adrenergic control may~     be affected by beta-blocker use.~   "
78824|NCT02535169|"~     This study looks as how a health education intervention strategy effects health outcomes in~     overweight and obese adolescents.~   "
78825|NCT02535156|"~     Neurophysiological indices of self-monitoring were assessed in a group of patients with~     Schizotypal Personality Disorder (SPD) and a control group. Both groups were assessed after~     the administration of risperidone and placebo.~   "
78826|NCT02535143|"~     This study aims to test the hypothesis that there was a relationship between the consumption~     of energy drinks and the manual dexterity skills of final year dental students.~      Identification of baseline caffeine consumption and selection of sample Baseline caffeine~     consumption will be identified by distributing the caffeine consumption questionnaire to all~     the final year students of the Riyadh Colleges of Dentistry and Pharmacy. The study will~     recruit 60 students who are moderate caffeine consumers. To avoid the confounding effect of~     nicotine consumption, the study will only recruit non-smokers .female candidates taken oral~     contraceptives and Subjects with any history of renal disease will be excluded.~      All subjects will be required to prepare a box 2mmx2mmx2mm using a high speed handpiece (NSK,~     Japan) and a no.330 cutting bur. Each participant will be allowed two attempts to cut the~     cavity in each test both cavities will be selected for assessment. The ability of the~     participants to reproduce the dimensions (2mmx2mmx2mm) and the time taken to complete the~     task will be used as criteria to evaluate dexterity. The participants will be required to~     perform the test before and 30 minutes after energy drink exposure.~      Energy Drink Exposure Subjects will be given 330ml of an energy three hours after the last~     meal in the other hand the control group will be receiving a placebo drink .~      Dexterity outcomes will be compared before and after exposure to the energy drink using the~     paired t test. Outcomes will be compared between different groups and different time~     intervals using the two way, multiple measures ANOVA. All data will be analyzed using the~     SPSS ver.21 data processing software.~   "
78827|NCT02535130|"~     The purpose of this study is to compare the efficiency of nebulization and positive~     expiratory pressure combination~   "
78828|NCT02535117|"~     Hepatocellular carcinoma (HCC) is the fifth most common and the third leading cause of death~     from cancer worldwide1 . Hepatectomy is still the main effective treatment for HCC~     accompanying with well-preserved cirrhosis when liver transplantation is not feasible due to~     the lack of donors Recurrence of tumor within the liver remnant is also common, with a~     reported 5-year recurrence rate of 50-70%, in patients who have undergone curative~     hepatectomy. Management of recurrent HCC is still urgent and several treatments have been~     developed. Repeat hepatectomy is considered to be the first choice for recurrent HCC with a~     5-year survival rate of 19.4 to 56%. Unfortunately, repeat hepatectomy can be performed only~     in a small proportion of patients with HCC recurrence due to the poor functional liver~     reserve or because of widespread recurrence. With a 3-year survival rate of 62% to 68% after~     treatment, radiofreqency ablation (RFA) has been used as an effective treatment for recurrent~     HCC. The efficacy of RFA for recurrent HCC has been reported to be comparable to those~     achieved by surgery. Laparoscopic surgery was considered not to be a suitable treatment for~     recurrent HCC due to postoperative adhesions that can make laparoscopic surgical procedure~     more difficult and less safe. Recently, several studies reported that laparoscopic surgery~     for recurrent HCC in cirrhotic patients is a safe and feasible procedure with good short-term~     outcomes. By far, no study has been performed to compare the efficacy and safety of~     laparoscopic surgery with RFA for treatment of recurrent HCC.~   "
78831|NCT02535078|"~     This study is a Phase Ib/II, multi-center, open-label study of IMCgp100 as a single agent and~     in combination with durvalumab (MEDI4736) and/or tremelimumab in metastatic cutaneous~     melanoma. The purpose of this study is to characterize the safety, tolerability,~     pharmacokinetics (PK), pharmacodynamics, and anti-tumor activity of IMCgp100 in combination~     with durvalumab (MEDI4736, programmed death-ligand 1 [PD-L1] inhibitor), tremelimumab (CLTA-4~     inhibitor), and the combination of durvalumab with tremelimumab compared to single-agent~     IMCgp100 alone. The study will enroll patients who have metastatic melanoma that is~     refractory to treatment with an anti-PD-1 inhibitor as well as patients naive to therapy in~     the metastatic setting.~      Recent biologic evidence indicates that optimal responses to programmed cell death-1 (PD-1)~     directed therapy require the presence of CD8+ T cells in the tumor microenvironment and thus~     therapies such as IMCgp100 that recruit these effector cells to the tumor may overcome~     pre-existing resistance to checkpoint blockade. This emerging biology of checkpoint inhibitor~     resistance suggests the combination of IMCgp100 with checkpoint inhibition may have enhanced~     activity in patients with pre-existing resistance.~   "
78832|NCT02535065|"~     The Zenith® Low Profile AAA Endovascular Graft Clinical Study is a clinical trial to study~     the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft used in~     conjunction with the Zenith® Spiral-Z® AAA Iliac Leg Graft to treat abdominal aortic,~     aortoiliac, and iliac aneurysms.~   "
78833|NCT02535052|"~     This study will investigate the function of the immune system in people with chronic kidney~     disease (CKD) compared to people with normal kidneys. The investigators will use standard~     vaccines - the seasonal flu vaccine and pneumococcal polysaccharide (Pneumovax) vaccine - to~     examine how the immune system responds to challenge. All subjects will receive these~     recommended vaccines as part of routine care. Blood and urine samples will be collected and~     tested at different time points to look at how the immune response develops to these vaccines~     and if there are any differences between people with CKD and those without. This will help us~     understand how CKD affects the function of the immune system.~   "
78834|NCT02535039|"~     Postoperative cognitive dysfunction (POCD) refers to the patients in the central nervous~     system complications after general anesthesia and clinical manifestations of mental disorder,~     anxiety, personality changes, impaired memory, personality, social skills and cognitive~     function after surgery for this decline is called postoperative cognitive dysfunction.Due to~     the lack of effective clinical treatments, how to prevent and solve the postoperative~     cognitive dysfunction has become a difficulty and a focus of research in the field of~     anesthesia.Methylprednisolone is a new type of cortical hormone, because of its strong~     anti-inflammatory effect, less adverse reactions, is widely used in clinical~     anesthesia.Electric acupuncture as a kind of traditional treatments, after years of clinical~     application and achieved good curative effect in practice.In this paper by comparing brain~     oxygen saturation, blood biochemical indexes, Montreal cognitive assessment scale (MOCA) on~     cognitive function in patients with grade indexes, such as observation of methylprednisolone~     combined electric acupuncture treatment of elderly patients with general anesthesia early~     after the operation, the influence of cognitive function.~      Through comparing the operation of cerebral oxygen saturation, blood biochemical indexes,~     Montreal cognitive assessment scale (MOCA) on cognitive function in patients with grade~     indexes, such as observation of methylprednisolone combined electric acupuncture treatment of~     elderly patients with general anesthesia early after the operation, the influence of~     cognitive function.~   "
78835|NCT02535026|"~     This is a descriptive, prospective, observational and epidemiological study on participants~     recently diagnosed with breast cancer to evaluate the HER2 status by IHC and SISH procedures.~   "
78836|NCT02535013|"~     Investigators hypothesized that perioperative lung ultrasound would be beneficial in~     pediatric patients undergoing cardiac surgery compared to those who did not receive lung~     ultrasound.~   "
78837|NCT02535000|"~     Duloxetine as an analgesic agent in patients undergoing elective spine surgery: evaluation~     with fentanyl demand controlled by the patient. The primary objective is to evaluate the~     efficacy of duloxetine in fentanyl consumption during the postoperative period of patients~     undergoing elective spine surgery by intervertebral disc degeneration . Secondary endpoints~     were pain scores and the presence or absence of adverse effects such as headache, nausea,~     vomiting, itching, dizziness and drowsiness.~   "
78838|NCT02534987|"~     The study is a randomized controlled trial, with an Intervention Group and a Control Group at~     the University of Utah (U of U) and University of Wisconsin (UW). BU serves as the primary~     award and coordinating institution. The unit of randomization will be at the clinic level at~     each institution. UW will recruit all General Internal Medicine (GIM) Clinics and Department~     of Family Medicine (DFM) Clinics in Dane County as well as their East and West Urgent Care~     Clinics. U of U will recruit all affiliated primary care practices. The unit of randomization~     will be the clinic.~      The study biostatistician will receive a list of clinic sites that have agreed to participate~     in the study from the site PIs. Clinics will be randomized to either Intervention group or to~     a Control group stratified by clinic size. Both groups will receive a single 45 minute~     academic detailing session describing evidenced-based diagnosis and treatment for strep~     throat and pneumonia. The Intervention Group will also receive a demonstration of the iCPR~     tool during their academic detailing session. Providers and clinic staff will be invited to~     the academic detailing session. Any provider or staff that is unable to attend the session~     will receive written and electronic copies of the material. Individual providers will not be~     specifically recruited for participation and they will participate or not based on personal~     preferences as they would for any clinic quality improvement project. The iCPR tool will be~     turned on for providers in the Intervention group. This means that the best practice alerts~     will trigger for appropriate patients with suspected strep throat or pneumonia.~      We will collect and analyze data about the use of each element of the iCPR tool during~     patient visits, including which elements of the tool were used and how often. We will also~     collect data from the site EHRs about antibiotic and diagnostic test orders for strep throat~     and pneumonia from all clinics participating in the trial, both Intervention and Control~     groups.~      After one year of study implementation, we will run an Interim Primary Outcome Report~     comparing the antibiotic and diagnostic test orders between the Intervention and Control~     group clinics. This report will be in the aggregate and will not contain any~     personally-identifiable information. If there is a significant difference between the groups~     that meets our predetermined stopping end points, we will stop the randomized controlled~     trial.~   "
78850|NCT02534831|"~     Chronic obstructive pulmonary disease (COPD) is a common preventable and treatable disease~     characterized by progressive airflow limitation that is associated with an inflammatory~     response to noxious particles or gases.~      Manual therapy (MT) has been defined as a therapeutic intervention that uses the hands to~     provide treatment to the musculoskeletal and/or visceral systems. It includes techniques such~     as massage, myofascial release, muscle energy technique, ligament balance, joint mobilization~     and joint manipulation. The suggestion that MT could deliver long-term benefits to people~     with COPD was first put forward in 2009. Since then a number of small studies have reported~     medium term improvements in lung function and exercise capacity following repeated~     applications of MT intervention.~      Our aim is to measure the immediate effect on lung function of a single application of soft~     tissue manual therapy in patients with severe and very-severe chronic obstructive pulmonary~     disease.~   "
78839|NCT02534974|"~     Ventilation-associated pneumonia is the main site of healthcare-associated infections in the~     severe trauma patient, with a mean incidence rate of 35%. Ventilator-associated pneumonia~     increases morbi-mortality, length of stay in intensive care and overall management costs. As~     was recalled by the jury of the 2008 SFAR-SRLF consensus conference on the prevention of~     nosocomial infections contracted in intensive care, success in this preventive endeavour~     depends on a number of measures: orotracheal intubation route, maintaining tube cuff pressure~     between 25 and 30 cm H2O, maintaining a semi-seated position ≥30°, nasal and oropharyngeal~     care at regular intervals, striving to avoid unscheduled extubation, and use of a written~     sedation-analgesia algorithm allowing for early weaning from ventilation.~      Devices ensuring continuous pneumatic control of tube cuff pressure are more efficient in~     maintaining tracheal balloon pressure than intermittent adjustments using a hand-held~     manometer. In one study, these devices clearly facilitated diminution of microaspiration of~     gastric contents and of ventilator-associated pneumonia incidence density (9.7 vs. 22~     VAP/1000 days of mechanical ventilation; p = 0.005).~      The investigators are putting forward the hypothesis that by adjoining a device providing~     continuous pneumatic regulation of tube cuff pressure to an overall strategy aimed at~     ventilator-associated pneumonia prevention (including semi-recumbent position ≥30°,~     oro-nasal-pharyngeal care at regular intervals and reduced risk exposure) can decrease VAP~     incidence by 50% in severely traumatised patients whose condition necessitates mechanical~     ventilation of an expected duration exceeding 48h.~      Ours is the first large-scale study to evaluate the interest of an innovative technology~     bundle on decrease of ventilator-associated pneumonia incidence in one of the intensive care~     populations the most at risk, namely severe trauma patients, a population presently~     benefiting from the other recommended preventive measures.~   "
78840|NCT02534961|"~     This randomized prospective study aims to investigate whether prophylactic administration of~     antibiotics has an influence on inflammatory markers, liver function test results, or the~     incidence of post-procedural infection in patients with hepatocellular carcinoma (HCC)~     undergoing radiofrequency ablation (RFA).~   "
78841|NCT02534948|"~     Anxiety and depressive disorders are common in all regions of the world. Anxiety disorders~     are considered as third major psychological issue in Pakistan (Panhwer, 2014). Objective of~     the present study is to see the feasibility and effectiveness of social anxiety in females~     with the help of mindfulness and acceptance based therapy. It is hypothesized that women in~     the intervention group will have significantly reduced anxiety as compared to the women in~     the control group. A total of 60 females in the age range of 18 to 28 ages will be selected~     from Institute of professional psychology and private clinics from Karachi city. The~     participants will be recruited through the administration of Mini-Social Phobia Inventory~     (SPIN-mini). The participants will be randomly divided in interventions and control group and~     will receive the intervention of ten sessions of group therapy of MABT plan. Assessment will~     be conducted at the baseline and at the end of the intervention.~   "
78842|NCT02534935|"~     The purpose of this study is to investigate the immunogenicity, safety and tolerability of a~     new vaccine that might prevent meningococcal B disease. The study will be conducted in~     healthy toddlers aged between 12 and 24 months.~   "
78843|NCT02534922|"~     This trial is a Phase I open-label safety study of Prolanta™, a recombinant analog of the~     human prolactin protein with a single amino acid substitution to create an antagonist of the~     prolactin receptor. The Sponsor believes that blocking the prolactin receptor in patients~     with ovarian and other cancers will be effective as a monotherapy or in combination with~     other chemotherapies. This Phase I study will be conducted in Subjects with recurrent or~     persistent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.~   "
78844|NCT02534909|"~     To determine whether LFG316 can induce a hematological response, as measured by reduction in~     hemolytic activity, in patients with PNH.~   "
78845|NCT02534896|"~     This study is designated to evaluate the safety and efficacy of Sunpharma1505 in subjects~     with active rheumatoid arthritis who are experiencing a flare/exacerbation.~   "
78846|NCT02534883|"~     Misoprostol (Cytotec) 200ug vaginally will be given to patients 12 hours and 2 hours~     pre-operatively (before surgery) for a total of 400ug to ripen, soften or relax the cervix~     for dilation (opening). This is to assist with the insertion of a hysteroscope (the surgical~     instrument) into the uterus for all operative hysteroscopic procedures requiring dilation~     above 5 mm.~      Time required for cervical dilatation will be recorded. Start time will be when the smallest~     dilator is placed into the endocervical canal, and stop time recorded when the desired~     cervical dilation is achieved with the largest dilator. Depending on the procedure, desired~     dilation may range between 5-10mm. Time will serve as a surrogate for operative ease of~     dilatation.~      The investigators will compare the two groups in terms of medication, resistance, dilation~     time and size, side effects and surgical complications.~   "
78847|NCT02534870|"~     The purpose of this study is to assess the pharmacokinetics and safety of multiple oral doses~     of ABT-450/ritonavir/ABT-267 and ABT-333 when co-administered under non-fasting conditions in~     healthy Chinese adult participants.~   "
78848|NCT02534857|"~     In vitro fertilization (IVF) treatment is now commonly used to treat infertile couples.~     During IVF treatment, oocytes and sperm are routinely incubated overnight and this may lead~     to suboptimal culture conditions because of increased reactive oxygen species (ROS) produced~     by sperm in the standard incubation. High levels of ROS can adversely affect the quality of~     the embryos, result in hardening of the zona pellucida and impair the implantation capacity~     of embryos. Studies shows successful fertilization of an oocyte occurs 20mins after the~     gametes are put together. Sperm can penetrate through the cumulus cells within 15min, and 80%~     of oocytes can be fertilized when they are exposed to a large number of spermatozoa within~     1hr. As an attempt to avoid possible detrimental effects on the oocytes from long exposure to~     sperm, the brief incubation insemination protocol was developed. It implies that prolonged~     incubation of oocytes and sperm may not be necessary and may even be harmful. Some reports~     suggest that a sperm-oocyte exposure time of 1-6 h improves IVF outcomes. However, other~     studies report no such advantage with a short insemination time .~      A recent meta-analysis shows brief incubation of gametes was associated with significantly~     higher rates of clinical pregnancy , ongoing pregnancy and higher rate of implantation than~     standard incubation. But the rates of normal fertilization, good quality embryos and~     polyspermy were not significantly different compared with standard incubation. In a Cochrane~     meta-analysis, eight RCTs with 733 women were included, and showed similar results. But it~     only reported clinical pregnancy rate and ongoing pregnancy rate which were significantly~     higher in brief incubation group than standard incubation. However, the live birth rate,~     which is the important outcome parameter, was not reported in all these studies. It is~     uncertain whether brief incubation improves the life birth rate compared with standard~     incubation.~      The aim of this randomized double blinded study is to compare the live birth rate of IVF~     treatment following brief incubation of oocytes and sperm versus standard incubation. The~     hypothesis is that a brief incubation improves the live birth rate of IVF treatment.~   "
78849|NCT02534844|"~     This study evaluates the efficacy and safety of 2-hydroxypropyl-β-cyclodextrin (VTS-270) in~     patients with neurologic manifestations of Niemann-Pick Type C1 (NPC1) Disease. Approximately~     two-thirds of patients will receive the study drug, 2-hydroxypropyl-β-cyclodextrin (HP-β-CD),~     while the remaining study participants will receive sham control.~   "
78851|NCT02534818|"~     The purpose of this study is to assess whether lower fluorescein sodium dosage can perceive~     the same detection rate per patient and per lesion for the detection of gastric intestinal~     metaplasia.~   "
78852|NCT02534805|"~     To use the PatientBuddy App to reduce 30-day avoidable readmissions in cirrhotic patients~     using a patient and caregiver perspective.~   "
78853|NCT02534792|"~     Aim With this retrospective study, the investigators would like to evaluate and, if possible~     confirm, whether earlier revalvulation of the right ventricular outflow tract is better than~     late revalvulation. Up to now, no analysis is done to validate this policy change.~      Patient selection All patients registered in the database of paediatric and congenital~     cardiology of the University Hospitals in Leuven, with sufficient follow-up data, and who~     underwent transannular patching at repair will be included in the study.~      Methodology and statistical analysis All files will be reviewed for demographic,~     electrocardiographic, echocardiographic, and outcome data. Besides descriptive statistics,~     Cox regression will be performed to detect whether the time period between repair and~     revalvulation influences clinical outcome (defined as death, heart failure hospitalization,~     redo-revalvulation, implantation of automatic defibrillator, endocarditis).~   "
78854|NCT02534779|"~     This open-label study will examine the disintegration/disappearance time, safety, and~     acceptability of placebo vaginal inserts. Participants will use a placebo vaginal insert~     twice: first for an in-clinic disintegration/safety assessment, and a second time for an~     at-home acceptability assessment, with safety assessed at the following clinic visit.~   "
78855|NCT02534766|"~     MISSION is a new and novel way of delivering highly specialised Chronic Obstructive Pulmonary~     Disease (COPD) care and has the potential to change the way COPD care across the UK is~     delivered as well as services for other long term health conditions. The MISSION model has~     been piloted in asthma which is the subject of an ongoing research study. This is the first~     model of this type in COPD and the current research study aims to evaluate the outcomes of~     the project. This will be done in several different ways. The study is a mixed methods~     evaluation of the new service comparing outcomes before and after the clinic using~     retrospective data analysis and prospective qualitative interview. The study will be~     conducted at Portsmouth Hospitals NHS Trust and will recruit patients who attend MISSION COPD~     clinics as well as staff who attended MISSION clinics in a professional capacity.~   "
78856|NCT02534753|"~     This is a Phase 1, single-dose study to evaluate the pharmacokinetics of intravenous Ascorbic~     Acid.~   "
78857|NCT02534740|"~     This is a 2 part study. In part 1 of the study, 3 different formulations of the same dose of~     tafamidis will be compared. Subjects will be fasted for each test and every subject will test~     all 3 different formulations. After swallowing tafamidis, tafamidis blood concentrations will~     be measured periodically for 6 days. After 14 days, subjects will take a different~     formulation of tafamidis and tafamidis blood concentrations will be measured periodically for~     6 days. After another 14 days, the last formulation will be tested in the same way. In part 2~     of the study, depending on the results of part 1, either none, one or 2 of the formulations~     tested in part 1 will be tested comparing the same formulation when given either with or~     without food. Additionally, depending on the results of part 1 of the study, different doses~     of the formulations may be compared.~   "
78858|NCT02534727|"~     Background:~      Many people around the world get tuberculosis (TB) and non-tuberculous mycobacteria (NTM)~     infections. Sometimes medicine that treats these infections does not get to where the~     bacteria are in the lungs. Researchers want to find a way to tell if enough medicine is~     getting to where it is needed in the lungs. They will look at how much medicine is in your~     sputum (what you cough up) compared to how much is in your blood. They will also investigate~     a new test to quickly figure out what medicines are likely to treat TB effectively.~      Objective:~      To determine the relationship between the concentration of TB drugs in plasma and sputum over~     time.~      Eligibility:~      People ages 18 and older who have TB or NTM infection that is suspected to be drug resistant.~     They must be taking TB or NTM medicines.~      Design:~      Participants will be screened with medical history.~      Participants will be in the study for 2 8 days.~      Participants will give 3 or more sputum samples over at least 2 different days. They will~     cough sputum into a cup.~      Participants will have blood drawn 4 times a day on 2 different days.~   "
78859|NCT02534714|"~     The purpose of this study is to determine if there is correlation between Vitamin D~     deficiency and spinal disease/spinal fusion surgery.~   "
78860|NCT02534701|"~     To monitor the effect of the ERIC® device in combination with SOFIA™ Distal Access Catheter~     on artery recanalization and on clinical outcomes in stroke patients using data from clinical~     routine application (ERASER).~      To additionally evaluate the effect of the ERIC® device in combination with SOFIA™ Distal~     Access Catheter on the final infarct volume as determined by advanced image postprocessing~     methods in the subgroup of patients with acute middle cerebral artery stroke (ERASER+).~   "
78861|NCT02534688|"~     randomized controlled trial~      Eligiblility criteria Provisional diagnosis Clinical presentation Progressive dysmenorrhea~     Chronic pelvic pain Deep dyspareunia Evidences of endometriosis Endometriotic nodule~     Cul-de-sac nodularity Endometrioma detected by ultrasonography size < 4 cm~      Inclusion criteria Female age 18-45 yr Moderate to severe pelvic pain categorized by VAS >50~     Previous sexual intercourse~      Exclusion criteria Co-existing other genital tract disease associated pain Previous hormonal~     use within 3 months History of DMPA treatment failure WHO eligibility criteria 2009 for DMPA~     and LNG-IUS Category 3,4 Fertility desire in upcoming 1 year~      Primary objective To compare efficacy of pain control in endometriosis associated pelvic pain~     between LNG-IUS and DMPA~      Secondary objective To compare side effect, continuation rate, satisfaction and quality of~     life between LNG-IUS and DMPA in treatment of endometriosis associated pelvic pain~      Primary outcome Severity of pelvic pain Measured by VAS score 0 mean no pain 100 mean most~     pain~      Secondary outcomes Vaginal bleeding pattern Side effects of systemic progestogen Lipid~     profiles Weight gain Quality of life Measured by quesionaire SF36 Satisfaction Measrured by~     linket scale 0-4 0 mean very dissatisfied 1 dissatisfied 2 not satisfied and dissatiffied 3~     satisfied 4 very satisfied Continuation rate Endometrioma size reduction~   "
78862|NCT02534675|"~     The purpose of this study is to learn more about personalized cancer therapy including~     response to treatment and side effects. Information from the patient's medical record~     regarding the tests and treatments they have received, or will receive, for their cancer will~     be collected. Genomic testing on tissue from the primary tumor or metastases will be used to~     match therapy recommendations. Patients in which there is no appropriate matched therapy will~     receive systemic chemotherapy according to their treating physician's discretion. This~     information will be used to describe whether or not patients respond better when their~     physicians choose to treat them according to the genetic makeup of their tumor.~   "
78863|NCT02534662|"~     Objectives: Study to evaluate safety and feasibility of an endoluminal vertical gastroplasty~     (EVG) using an endoluminal-suturing device.~      Briefly, Vertical gastric plication is a novel surgical approach for reducing the stomach~     capacity. Anterior surface plication and greater curvature plication are variations of~     vertical gastric plication that reduce the gastric capacity through infolding of the anterior~     surface or greater curvature of the stomach, respectively. These approaches have been tested,~     with positive results.~      A transoral or endoluminal approach (ie, a procedure that requires no incision, because~     access is granted through the mouth) offers the potential for additional benefit to the~     patient, because the procedures continue to become more and more minimally invasive.~      Advances in endoluminal devices are now allowing clinicians the ability to begin exploring~     bariatric procedures performed via flexible endoscopy. Although these procedures may not be~     as effective as their surgical counterparts, these less-invasive options may relieve patients~     of the significant risks associated with surgery.~      Study duration and number of subjects A period of approximately 6 months is anticipated form~     the time the time the first patient is enrolled to the completion of the last patient.~      The participants will be followed as follow:~      Day (0): Procedure Day (+1): Clinical Follow up and discharge (i.e. if no adverse effects~     observed)~      1 month: Follow up endoscopy, Clinical assessment 3 month: Follow up endoscopy, Clinical~     assessment 6 month: Final assessment (Endoscopically and Clinical) On Parallel a nutritional~     specialist will monitor the patient on quarterly basis (1,3,6,12).~      Study procedures The intervention will be performed under general anesthesia with tracheal~     intubation. Endomina will be introduced into the stomach over guide wires and then fixed to~     the endoscope. The procedure will include the placement of 4-6 transmural anterior-posterior~     sutures after argon plasma coagulation of the tissue opposition areas in order to ensure~     persistence of the pouch reduction. Patient will be kept overnight after the procedure.~   "
78864|NCT02534649|"~     This is a biology driven, monocentric study designed to identify actionable molecular~     alterations in cancer patients with advanced disease.~      In this trial, high throughput analysis will be carried out using next generation sequencing,~     and immunological profiling.~      Patients included in the BIP study and for whom a targetable genomic alteration had been~     identified might be subsequently included in an early phase trials running at Institut~     Bergonie or another French hospital.~   "
78865|NCT02534636|"~     The purpose of this study is to establish if BMS-986165 is safe and effective at treating~     autoimmune diseases. BMS-986165 which has shown some promise in preclinical studies for~     inhibiting autoimmune conditions. This study will be the first time this drug is given to~     humans, and will be conducted entirely in healthy subjects. It will be run in 4 Parts. Part A~     will investigate single oral doses of drug. Part B will investigate giving the drug daily for~     14 days. Part C will investigate daily doses for 14 days in healthy volunteers with Japanese~     decent. Part D will investigate whether food, stomach acidity or giving the drug in a capsule~     makes a difference to the safety and potential use of this drug.~   "
78866|NCT02534623|"~     Transurethral resection of the bladder (TURB) is often performed as an outpatient procedure~     so high-quality postoperative recovery is particularly important. The aim of this study is to~     compare postoperative quality of recovery after spinal anesthesia (SA) and general anesthesia~     (GA) for transurethral resection of the bladder.~   "
78867|NCT02534610|"~     Evaluation of the efficacy of preemptive versus postoperative administration of etoricoxib in~     total knee arthroplasty (TKA).~   "
78868|NCT02534597|"~     This evaluation seeks to assess the impact of a training program on childcare center~     environments and child/caregiver wellbeing in El Salvador. Through a longitudinal, randomized~     control trial, over 200 childcare centers participating in the program will be assigned to~     various treatment arms receiving different components of the program. A community comparison~     cohort will also be enrolled.~   "
78869|NCT02534584|"~     This study is a service evaluation to assess the impact of compliance of Acute Kidney Injury~     care bundle (AKI-CB) on clinical and renal outcomes. The AKI care bundle is coupled with an~     interruptive electronic alert, which is triggered by the first attempt to order blood tests~     or medications on patients who have been identified as having AKI by the electronic~     recognition from serum creatinine results. The interruptive alert will warn the clinician~     about AKI and request them to complete the AKI care bundle. Once the AKI care bundle is~     completed, the clinician is able to request blood tests or medication. The clinician will be~     able to override the alert only after stating the reason. Education with respect to~     importance of AKI and the AKI-CB is provided every four months when junior doctors rotated~     through different specialities and also at clinical governance days. The investigators will~     compare AKI episodes, which have the AKI-CB completed early (defined as within 24 hours of~     availability of the blood results) with those who either had the AKI-CB completed late~     (defined as after 24 hours of availability of the blood results) or not completed at all. The~     AKI patients who either had the AKI-CB completed late or not completed will be considered as~     not having the AKI-CB completed for this analysis.~   "
78870|NCT02534571|"~     Acute upper gastrointestinal bleeding is a common medical emergency. Bleeding peptic ulcers~     and other non-variceal causes constitute to about 95% of all cases of bleeding. Endoscopic~     treatment stops active bleeding, reduces rate of further bleeding and leads to improved~     patients outcomes. Endoscopic treatment can be technically demanding especially with lesions~     in difficult anatomic positions and to endoscopists with less experience. TC-325 is a~     propriety mineral blend hemostatic powder used to compress external civilian and military~     traumatic injuries. Investigators reported the first endoscopic application of TC-325 in 20~     patients with actively bleeding gastro-duodenal ulcers. Investigators were able to stop~     bleeding in 19 of them. Subsequent case series from others reported a similar rate in the~     acute control of bleeding. To further define the role of TC-325 as a mono-therapy, a~     comparison to the current standard in endoscopic treatment is required. A non-inferiority~     randomized trial is being proposed to compare endoscopic use of TC-325 as a mono-therapy to~     current standards (i.e. hemoclips or thermo-coagulation with or without pre-injection with~     diluted epinephrine) in hemostatic treatment in patients with acute upper gastrointestinal~     bleeding from non-variceal causes. The non-inferiority primary endpoint is control of~     bleeding over 30 days from randomization. Other outcome endpoints include further endoscopic,~     angiographic or surgical treatments, hospitalization, blood transfusion and mortality.~     Investigators also compare ease of therapy measured by procedure time and a 10 cm visual~     analogue scale rated by endoscopists. Endoscopic application of TC-325 is a simple and less~     skill dependent technique. It may prove useful in bleeding from anatomically challenging~     sites of the gastro-duodenal tract.~   "
78871|NCT02534558|"~     The team integrates experimental analyses of clinical and basic medicine and transgenic mice~     models. miR-29a acts a potent protective factor against excessive fibrosis in myofibroblasts~     of subacromial bursa tissue. Gain of miR-29a stabilizes tendon and synovial tissue~     homeostasis that alleviates tissue stiffness and maintains function.~   "
78872|NCT02534545|"~     The primary objective of the study will be to determine whether remote limb ischemic~     conditioning (RLIC) compared with sham RLIC (placebo) treatment reduces the 12-month risk of~     recurrent IS in patients with a recent TIA or IS caused by stenosis of a major intracranial~     artery.~      After screening period, eligible patients will be randomly allocated into 2 groups. In~     addition, all participants receive an usual clinical therapy.~   "
78873|NCT02534532|"~     Question: Can atrial fibrillation (AF) cases in patients ≥ 65 years be easily detected in a~     primary healthcare environment using a smartphone device and iECG application as an~     opportunistic screening tool?~      Objectives:~      Detection of AF through cardiac rhythm abnormalities in patients ≥65 years old in an~     opportunistic screening program using a smartphone device/application~        1. Define the predictable value of the smartphone device with electrocardiogram (ECG)~          confirmation to detect AF in patients 65 years and older~        2. Correlate screened patients cardiovascular risk profile and those that register cardiac~          rhythm irregularities for a better description of the general characteristics of~          Colombian population~   "
78874|NCT02534519|"~     No health condition(s) are studied. Genetic background of blood groups is studied. U- and~     Stones(a)+ (Caucasian type) are used as proof-of-principle samples. Disease associations of~     all blood group genes investigated are very rare, e.g. < 1 among 1'000 Swiss individuals (see~     table 1), and are not to be expected in the course of this study.~      Genomic DNA of 2 U- samples were both provided as blinded reference material from New York~     and Vienna blood centres, respectively. Both donors are lost for follow up, and although~     there is no documented evidence for refusal of the respective donors to use their material in~     research projects, samples still lack informed consent.~   "
78875|NCT02534506|"~     The purpose of this study is to assess the safety and tolerability of BMS-663513 in subjects~     with advanced and/or metastatic malignant tumors.~   "
78876|NCT02534493|"~     A single-center, prospective, non-randomized study to evaluate the safety and efficacy of a~     novel carpal tunnel tissue manipulation device in treating symptoms and decreased physical~     function in subjects previously diagnosed with mild to severe carpal tunnel syndrome (CTS).~   "
78877|NCT02534480|"~     NGP 555 is a small molecule preventative therapy aimed at reducing Alzheimer's disease~     amyloid buildup by targeting Abeta 42 production.~   "
78878|NCT02534467|"~     An open-label (outcome assessor blinded) prospective crossover cohort study of children 6-16~     years assessing effects of Montelukast on moderate to severe atopic dermatitis.~   "
78879|NCT02534454|"~     The purpose of the phase 1 translational pilot study proposed here is to gather preliminary~     data investigating the efficacy of transcranial direct current stimulation (TDCS) and~     cognitive retraining to enhance nicotine replacement therapy for smoking cessation. The~     recent use of TDCS over task relevant regions to alter behavior holds incredible promise for~     use in cognitive retraining intervention protocols. Previous studies of cognitive retraining~     have focused on implicit training techniques. This proposed study will attempt to enhance~     these implicit training techniques through the use of TDCS during implicit retraining in~     order to increase learning of avoidance-related action tendencies towards tobacco. The~     objective of this pilot study is to establish the feasibility and obtain preliminary data on~     the effectiveness of using brain stimulation with cognitive retraining to reduce cigarette~     smoking in individuals with nicotine addiction.~   "
78880|NCT02534441|"~     The primary objectives of this study are to identify positivity rates to three novel~     surfactants (ingredients used in soaps, detergents, and other cleansers that serve to lower~     the surface tension of the skin and remove debris) and co-reactivity with other surfactants~     in patients with known surfactant sensitivity on skin patch testing. The investigators~     hypothesize that subjects who previously tested positive to known allergenic surfactants~     (cocamidopropyl betaine, stearamidopropyl dimethylamine, dimethylaminopropylamine, coconut~     diethanolamide, oleamidopropyl dimethylamine, and decyl glucoside) may demonstrate~     co-reactivity to the three novel surfactant sensitizers (sodium lauroyl sarcosinate,~     isostearmidopropyl morpholine lactate, and disodium lauroamphodiacetate) on skin patch~     testing.~   "
78881|NCT02534428|"~     The study is a sequentially recruited, cross-over-cohort, outpatient-based evaluation of the~     effectiveness of wool clothing, as compared to standard clothing, in reducing the severity of~     childhood atopic dermatitis over two consecutive six-week periods.~   "
78882|NCT02534415|"~     Aim of the study is to assess the therapeutic effects of topical hyaluronic-acid use on~     secondary wound healing of the free gingival graft donor site. The hypothesis of this study~     is that topical hyaluronic-acid gel has positive effects on secondary wound healing of free~     gingival graft donor site by reducing pain, burning sensation, and accelerating the healing.~   "
78883|NCT02534402|"~     In this study, prednisone dose, day/time administration will be controlled in a stable COPD~     patient population to determine its effect on peripheral whole blood gene expression. This~     data has never been collected in a COPD population using the investigators' chosen platform~     for gene expression (Affymetrix Human Gene 1.1 ST). Conducting this experiment is essential~     for achieving the broader aims of an already existing and related study titled Clinical~     Implementation and Outcomes Evaluation of Blood-Based Biomarkers for COPD Management study.~     As part of this existing study, blood is being collected from hospitalized and~     non-hospitalized COPD patients in order to develop a blood-based biomarker test for the~     diagnosis and prediction of acute exacerbation of COPD (AECOPD). The majority of these~     patients were administered prednisone as part of standard care for the treatment of AECOPD.~     As such, the effect of prednisone on gene expression needs to be ruled out.~   "
78896|NCT02534233|"~     Cryoablation (cryotherapy) is an established type of mucosal ablation for treatment of~     various conditions in the GI tract, including Barrett's esophagus and esophageal cancer. The~     purpose of this study is to assess the safety, feasibility and performance of cryoablation~     system (the C2 Focal Cryoablation Device in patients with BE and esophageal squamous~     dysplasia who need ablation therapy for clinical standard care. The new cryoablation~     treatment will be offered as an alternative to standard ablation therapies already in place~     (radiofrequency ablation, carbon dioxide cryotherapy).~   "
78897|NCT02534220|"~     The aim of this study is to evaluate the gingival margin stability with the use of~     oscillating-rotating toothbrushes compared to manual toothbrushes.~   "
78884|NCT02534389|"~     Neoadjuvant treatment with radiotherapy (RDT) and chemotherapy (CT) are the treatment of~     choice for rectal adenocarcinomas in stages II and III. This results currently in pathologic~     complete response in 10% to 30% of cases. The immune and inflammatory response is altered in~     these individuals and is directly related to response to therapy. Both the disease and the~     treatment of colorectal cancer have an impact on quality of life and nutritional status. In~     studies with cells and animal models the incorporation of fatty acids eicosapentaenoic acid~     (EPA) and docosahexaenoic (DHA) - derived from fish oil - has been shown to interfere in the~     process of inflammation, cell signaling and gene transcription enhancing the response to~     treatment. Are reported ability to restore the apoptosis of tumor cells, sensitization of~     tumor cells to chemotherapy, production of less pro-inflammatory cytokines and the~     preservation of normal energy and protein metabolism. The aim of this study is to verify if~     the daily consumption of 2.4 g EPA + DHA for adults in neoadjuvant therapy can promote~     changes on inflammatory and immunological markers of host response to tumor and if this~     response is altered by nutritional status. It is expected that supplementation can reflect in~     control of inflammatory and immune response in favor of tumor cell death contributes to~     pathological complete response and that it happens with preservation of nutritional status.~     Subjects will be randomized as to supplementation. All will be assessed in four moments~     during neoadjuvant therapy and immediate postoperative. Results will be presented by~     comparing the intervention group and control group at each moment.~   "
78885|NCT02534376|"~     There is evidence in human studies as well as animal studies that treatments to lower~     cholesterol can reduce the risk of dying from prostate cancer.To decide if~     cholesterol-lowering therapy can slow the growth of prostate cancer, the investigators would~     like to lower cholesterol prior to surgery and then measure the growth of prostate cancers~     cells when the prostate has been removed. The investigators will use the combination of two~     drugs that is approved by the U.S. Food and Drug Administration to lower cholesterol. The~     drug combination is commercially available with a doctor's prescription and sold as Vytorin®.~     It is known that maximal cholesterol-lower effects are seen after 2 weeks of treatment with~     Vytorin®. Therefore, study patients receive at least 2 weeks, but no more than 6 weeks of~     Vytorin® prior to surgery.~   "
78886|NCT02534363|"~     Cognitive enhancement is a primary goal in treating individuals with schizophrenia. Cognitive~     deficits are already present at the first break of the illness, seem to remain stable during~     early phases and noticeably influence daily functioning. Differences among antipsychotics in~     terms of cognitive effectiveness have turned out to be a topic of increasing research~     interest. The initially postulated superior neurocognitive effectiveness of second-generation~     antipsychotics (SGAs) compared to first-generation antipsychotics (FGAs) is currently under~     debate. Long-term studies would be of great value to evaluate the differential benefits~     exerted by antipsychotic drugs on cognitive performance. The aim of this study is to~     investigate the cognitive effects of aripiprazole, quetiapine and ziprasidone in~     first-episode psychosis at 1 year.~   "
78887|NCT02534350|"~     This study will evaluate the effect of presatovir on nasal respiratory syncytial virus (RSV)~     viral load in RSV-positive lung transplant (LT) recipients with acute respiratory symptoms.~   "
78888|NCT02534337|"~     The purpose of this study is to determine that Gemcitabine(GEM) plus oxaliplatin(OXA) (GEMOX)~     is superior to Oxaliplatin Plus Fluorouracil/Leucovorin(FOLFOX4) in prolonging~     progression-free survival（PFS） in patients with Advanced Hepatocellular Carcinoma.~   "
78889|NCT02534324|"~     The current guideline of asymptomatic severe hypertension (ASH) treatment in emergency~     department (ED) recommends through low level of evidence that the patients should not be~     rapidly decreased their BP in ED but instead receive oral antihypertensive treatment and~     close outpatient follow-up is needed. Unfortunately, there was some ambiguity in the time~     point of BP measurement in ED described in the past literature because high BP on ED~     admission may significantly decrease within hours without any medications. The importance of~     pre-ED discharge BP, which can still be critically high, that may affect the follow-up~     outcome has never been investigated. The study aim of this study is to evaluate the~     physicians' treatment strategies as well as immediate clinical outcomes between patients with~     severely- and moderately-elevated pre-discharge BP after management of ASH its in ED during~     the recent recommendation. The secondary outcome is to compare the BP at follow-up in these~     two groups.~   "
78890|NCT02534311|"~     The purpose of this clinical trial is to prospectively evaluate RA activity using the~     assessment of change in DAS28 under local conditions in Slovakia in participants who are~     treated with subcutaneously administered tocilizumab pursuant to the recommendations of the~     Ministry of Health of the Slovak Republic in order to better assess the disease activity and~     impairment of the joint function.~   "
78891|NCT02534298|"~     The objective is to study the relation between the reorganization of the central auditory~     system, and the psychophysical deficits in binaural hearing in subjects with single sided~     deafness.~   "
78892|NCT02534285|"~     The investigators hypothesize that the noise level in the operating theatre influences the~     patients' requirements of anesthetics. Study subject are patients undergoing abdominal~     surgery in combined general and epidural anesthesia. Analgesia is maintained by epidural~     injections of sufentanil and ropivacaine whereas general anesthesia is maintained using the~     inhalational anesthetic desflurane. Desflurane requirements are adjusted using~     neuromonitoring (BIS-Index). Intraoperative noise levels are recorded. Patients are~     randomized to receive hearing protections or not.~   "
78893|NCT02534272|"~     D.fragilis is an intestinal protozoon that feeds by phagocytosis of intestinal bacteria. The~     study aim to determine if the carriage of the intestinal parasite D.fragilis is associated to~     changes of gut microbiota in subjects presenting with or without intestinal symptoms.~   "
78894|NCT02534259|"~     The objective of this study is to develop methods for using forces measured on circular~     external fixators to predict the state of individual patient's healing of severe tibial~     fractures and defects.~   "
78895|NCT02534246|"~     The aim of this study is to evaluate and compare the diagnostic accuracy and specimen~     adequacy of two ultrasound biopsy needles. These are two existing FDA approved tissue biopsy~     regimens, with respect to diagnosis of solid pancreatic lesions.~   "
78933|NCT02533752|"~     Canadian WATCHMAN Registry is a multicentre (8 Centres) Canadian prospective, non-randomized,~     registry to enrol 100 consecutive patients undergoing LAA closure with the WATCHAN device to~     study the safety and effectiveness of the WATCHMAN device~   "
78898|NCT02534207|"~     This study will evaluate the relationship between basmisanil plasma concentrations and the~     occupancy of Gamma-Amino Butyric Acid A (GABAA) receptor subtypes containing an alpha5 (α5)~     subunit in healthy Japanese volunteers. Each participant will have two post-screening imaging~     sessions. In the first imaging session, participants will have a baseline Positron Emission~     Tomography (PET) scan. In the second imaging session, participants will receive a single oral~     dose of basmisanil, followed by two on-treatment PET scans at about 4 and 10 hours post-dose.~   "
78899|NCT02534194|"~     In the UK and worldwide many babies are born without carers knowing their gestation as the~     mothers will not have had good antenatal care. It is possible to estimate gestation but this~     requires a detailed clinical exam. The investigators wish to improve this by using software~     analysis to pick out features of the baby (face and foot) to try and estimate the gestation~     of the baby once it is born. The investigators will also look explore if the software can~     distinguish the normal face or a baby in discomfort.~      Good estimation of gestation can result in more targeted management of the baby. The~     investigators will capture the images of newborn babies, from a variety of gestations, and~     use this dataset to teach the software to estimate gestational age and level of discomfort.~   "
78900|NCT02534181|"~     The purpose of this study is to evaluate whether a nutritional strategy is effective in~     critically ill patients with cancer diagnosed with refeeding syndrome.~   "
78901|NCT02534168|"~     Pain assessment in infants and toddlers is quite challenging since children in these~     populations are nonverbal or preverbal and cannot describe the presence and severity of pain~     that they perceive. Over the last decade, advances in the field have included the development~     of behavioral scoring systems for the assessment of acute pain . However, although they have~     been validated, these commonly used methods of pain assessment are largely subjective and~     rely on a highly trained observer. An objective continuous measure of pain would be an~     important addition to standard behavioral painscores which require nurses to monitor the~     child's behavioral responses.~   "
78902|NCT02534155|"~     The study is comparing MitraClip® to Surgical therapy in high and intermediate risk patients,~     who should be older than 18 years, and shall evaluate safety and efficacy of MitraClip® vs.~     surgery in high or intermediate risk patients. The patients will be randomised (MitraClip® or~     Surgery). The Study Follow-Up includes 4 visits after procedure (hospital discharge, 1, 6, 12~     months post-procedure).~   "
78903|NCT02534142|"~     Approximately 40% of members with a positive fecal occult blood result do not continue to~     followup colonoscopy in Meuhedet. The purpose of this study is to identify the structural,~     process, carer and patient related causes of undertreatment and suggest appropriate~     organisational interventions. Using both quantitative and qualitative methods, the~     investigators will identify organisational and personal barriers to completion of followup of~     positive FOBT.~   "
78904|NCT02534129|"~     Phase II trial of the silibin containing cream, Difinsa53 to determine efficacy in delaying,~     ameliorating, or preventing radiation dermatitis in patients with breast cancer undergoing~     whole breast radiation.~   "
78905|NCT02534116|"~     The purpose of this study is to compare outcomes between incisional negative-pressure wound~     vacuum-assisted closure (VAC) therapy versus conventional dressings following abdominal~     surgery.~   "
78906|NCT02534103|"~     As considering the close relationship between systolic dysfunction and diastolic dysfunction,~     the EAS index e'/(a' x s') including systolic and diastolic function could be expected to~     predict hemodynamic changes during off-pump coronary artery bypass surgery(OPCAB). Exposure~     of the grafting site during OPCAB needs displacement of the heart, resulting in hemodynamic~     instability.~      Therefore the investigators are going to evaluate EAS index with preoperative Transthoracic~     echocardiography(TTE) and want to know the relationship between preoperative EAS index and~     intraoperative hemodynamic changes in patients undergoing OPCAB, in a prospective~     observational study.~   "
78907|NCT02534090|"~     Nowadays feeding intolerance (FI) is a common condition among preterm infants. It has been~     estimated that 16%-29% of premature infants admitted to neonatal intensive care units (NICUs)~     develop feeding intolerance at some point during their length of stay. The most frequent~     signs of FI are the presence of abdominal distension, abundant and/or bilious gastric~     residuals and vomiting suggesting an inability of the infant to further tolerate enteral~     nutrition, it increases with decreasing in gestational age (GA) and birth weight (BW). FI~     represents one of the most uncontrollable variables in the early nutritional management of~     these infants, and may lead to suboptimal nutrition, delayed attainment of full enteral~     feeding and prolonged parenteral nutrition supply.~      NIRS has been used in preterm infants to evaluate changes in cerebral perfusion and~     oxygenation. It provides real time insight into the oxygen delivery, presented as regional~     oxygen saturation rSO2 with lower values than SpO2 distal pulse-oximetry where is mostly~     measured as arterialized capillary bed (around 55% vs 98% Oxygen saturation in regional NIRS~     vs conventional pulse-oximetry). Light easily penetrates the thin tissues of the neonate~     through bone and soft tissue, particularly the thin capillary bed of the tissues; NIRS~     provides non-invasive, continuous information on tissue perfusion and oxygen dynamics.~      This technique uses principles of optical spectrophotometry that make use of the fact that~     biological material, including the skull, is relatively transparent in the NIR range.~      Dave et al. evaluated the abdominal tissue oxygenation with NIRS, and showed that preterm~     infants change their cerebral - splanchnic oxygenation ratios during feedings, mainly because~     an increasing in the splanchnic oxygenation.~      Gay et al. performed abdominal NIRS in premature piglets showing association of~     perfusion/oxygen changes with NEC spectrum.~      The investigators would like to evaluate the association between feeding intolerance and~     unchanged splanchnic regional saturation and variation in the cerebral splanchnic ratio.~      Innovation:~      FI diagnosis follows a subjective approach, where the clinician is worried in further risk of~     develop Necrotizing enterocolitis (NEC). This non-studied relationship (FI and NEC) lower the~     threshold for the diagnosis of FI. Furthermore, infants with FI diagnosis commonly are~     subject of stop or slow the progression of feedings, increasing the risk of intestinal villi~     atrophy, and increase the length of parenteral nutrition support, and also the length of stay~     in the NICU settings. If NIRS technology help the clinicians to detect true abnormalities~     objectively as a new monitor assessing adequate feeds progress decreasing failure to feed,~     and therefore diminishing the need for parenteral feeds and further complication associated~     with it.~   "
78908|NCT02534077|"~     To provide a mechanism for critically ill infants with parenteral nutrition (PN) associated~     cholestasis to receive Omegaven for compassionate use situations for which there are no~     satisfactory alternative treatments.~   "
78909|NCT02534064|"~     The purpose of this study is to evaluate the effect of daily consumption of one or two CALIN+~     pot(s) versus no intake of product, after 4, 8, 12 and 16 weeks, on the evolution of the~     serum concentration of 25-hydroxy vitamin D (25OHD) (D2 + D3) in postmenopausal women.~   "
78934|NCT02533739|"~     The purpose of these studies is to determine whether vestibular disorders could affect~     visuo-spatial cognition. Visuo-spatial cognition will be evaluated using a new questionnaire~     and a new computerized test using a digital tablet in different studies.~   "
78935|NCT02533726|"~     The purpose of this study is to test whether optimal patient turning, strictly every 2 hours~     with at least 15 minutes of tissue decompression, reduces the occurrence of hospital acquired~     pressure ulcers.~   "
78910|NCT02534051|"~     Clinics will be randomized to the use of the care pathway for obese pregnant women or~     standard care. Women who are (1) up to 20 weeks + 6 days gestation into their pregnancy, (2)~     are carrying one baby (not twins) that is healthy (no life threatening anomalies) and (3)~     have a Body Mass Index ≥ 30 kg/m², will be included. Data will be obtained from the Ministry~     of Health's Antenatal Records, charts, and for those in the intervention group, the care path~     (filled out by the practitioners - the participants' obstetrician, midwife, or family~     doctor). At the end of the study, practitioners will complete a survey, participate in~     structured interviews to understand barriers, facilitators, and motivators of using the care~     path.~      Primary Objective:~      To evaluate the feasibility of implementing and testing a clinical care pathway for obese~     pregnant women in a pilot cluster randomized controlled trial (RCT)~      Secondary Objectives:~      To obtain pilot data on A) process outcomes (steps of the pathway, e.g. what % of obese women~     receive a screen for diabetes) B) clinical outcomes (e.g. what % of obese women receive a~     diagnosis of diabetes), C) provider outcomes (e.g. Is the intervention acceptable, feasible &~     efficient? Barriers & facilitators to use, effectiveness? [Structured interviews])~   "
78911|NCT02534038|"~     Treatment of disinhibition syndrome in participants with Neurodegenrative Disorder.~   "
78912|NCT02534025|"~     Remote (upper arm) ischemic preconditioning in the donor of living donor liver transplanta to~     ameliorate the effect of reperfusion injury in recipients.~   "
78913|NCT02534012|"~     Elderly patients are usually presented with higher risk for developing cardiopulmonary~     complications after general anesthesia (GA). Bilateral paravertebral block (PVB) has been~     associated with favorable outcomes in patients undergoing ventral hernia repair. Hence,~     elderly patients undergoing major abdominal surgery may benefit from PVB anesthetic~     technique.~   "
78914|NCT02533999|"~     Given the large numbers of children who undergo tonsillectomy (by the time a child is 15~     years old, 13% of his/her peers will have had a tonsillectomy), the significant morbidity,~     and direct and indirect costs associated with absences for child from school or parent from~     work or other responsibilities, it is vitally important to identify surgical techniques which~     will minimize pain and serious negative outcomes. This study aims to compare a new surgical~     technique, PEAK® Surgery System, with electrocautery, one of the most commonly used methods~     for tonsillectomy with or without adenoidectomy in children 3 to 6 years old with a diagnosis~     of sleep-disordered breathing.~      In this project, the investigator will evaluate intra-operative outcomes including, surgery~     time and bleeding rates, and post-operative pain scores, bleeding rates, time to resumption~     of normal diet and activity, analgesic type and use, and frequency of emergent visits over 14~     days following surgery.~      The hypothesis is that there is no difference in outcomes between the traditional~     extracapsular electrocautery dissection method of tonsillectomy versus the newly introduced~     Peak® Surgery System.~      The long-term goal is to minimize pain and risk of bleeding and shorten the time to~     resumption of normal eating and activities in children undergoing tonsillectomy.~   "
78915|NCT02533986|"~     The main objective of this study is to investigate the effect of a 4-weeks intake of berry~     peel powder on fasting and postprandial glucose metabolism and inflammatory markers. The~     berry peel product will be compared with a placebo in a single-blind, cross-over design.~     Furthermore, inflammation-related peripheral blood mononuclear cells (PBMCs) genes~     expression, appetite and cognitive performance will be included as a pilot study.~     Investigators hypothesize that long-term consumption of polyphenols and fibres of berry peel~     will exhibit both direct and indirect actions in healthy overweight subjects by improvement~     of glucose-associated markers as well as ameliorating inflammation. Moreover, above metabolic~     markers will correlated with improvements in inflammation-related PBMCs genes expression,~     subjective appetite and cognitive performance after long-term consumption of berry peel as a~     source of polyphenols.~   "
78916|NCT02533973|"~     A phase 4 trial comparing the safety and efficacy of treatment with Xamiol® gel (calcipotriol~     50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)) once daily (as required) with~     Daivonex® scalp solution (calcipotriol 50 mcg/g) twice daily (as required) in Chinese~     subjects with scalp psoriasis~   "
78917|NCT02533960|"~     The Registry of Acute Stroke Under Novel Oral Anticoagulants-Prime (RASUNOA-Prime), an~     investigator-initiated study, is a German multicenter, prospective, observational registry.~     It is performed at about 50 certified stroke-units and supported by an unrestricted grant~     from different pharmaceutical companies to the Heidelberg University Hospital. RASUNOA-Prime~     is designed to assess the emergency management of acute ischemic and hemorrhagic stroke~     patients with atrial fibrillation (AF) under different anticoagulation schemes pre stroke:~     Non-vitamin K antagonist oral anticoagulants (NOAC), Vitamin K antagonists (VKA), and no~     anticoagulation.~   "
78918|NCT02533947|"~     Studies suggest that patients with hematological malignancies undergoing allogeneic~     hematopoietic stem cell transplantation (HSCT) are at risk for cognitive decline and~     long-term cognitive dysfunction. To address this issue, a randomized controlled intervention~     trial on the effect of physical exercise on cognition is conducted. In addition, the impact~     on psychological and physical health outcomes is evaluated. Results may benefit patients who~     suffer from disease- or treatment-associated cognitive change.~   "
78919|NCT02533934|"~     Retrospective/Prospective, open-label study using sofosbuvir based DAA therapy to treat~     HIV/HCV coinfected pre or post liver transplant participants~   "
78920|NCT02533921|"~     The purpose of this study is to improve outcomes for persons living with Parkinson's Disease~     (PD) and their family caregivers. The investigators hypothesize that outpatient~     interdisciplinary palliative care will improve patient-centered outcomes for PD patients at~     high-risk for poor outcomes.~   "
78921|NCT02533908|"~     This study analyzes the analgesic efficacy and adverse events of nitrous oxide 70% combined~     with basic analgetics compared to nitrous oxide 70% with fentanyl intranasal for~     analgosedation for short and painful procedures in children.~   "
78936|NCT02533713|"~     This is a randomized clinical trial to quantify the effects of exoskeleton-assisted gait on~     the musculoskeletal system and health-related quality of life.~   "
78970|NCT02533271|"~     The purpose of this study is to compare effectiveness of short-term radiotherapy with~     neoadjuvant chemotherapy(Experimental group) with preoperative long-term~     chemoradiotherapy(Control group) in locally advanced rectal cancer. The hypothesis is 3-year~     disease-free survival in Experimental group was non-inferior to that in Control group.~   "
78922|NCT02533895|"~     This is an un-blinded Phase 1 study in which 21 patients suffering from solid advanced~     paediatric malignancies (14 sarcoma and 7 non-sarcoma patients) are treated with AV0113, an~     anti-tumour immune therapy with autologous Dendritic Cells (DCs) loaded with tumour cell~     lysates, in order to investigate its safety and feasibility.~      For obtaining a clearer picture of AV0113's utility in the treatment of bone and soft tissue~     sarcoma, a long-term (LT) follow-up investigation of the 14 sarcoma patients, which will be~     treated using the AV0113 Dendritic Cell Cancer Immune Therapy (DC-CIT) technology is planned,~     in order to gather first evidence for a potential LT effect of DC-CIT with AV0113.~      Furthermore, a comparison of the 14 sarcoma patients treated with AV0113 DC-CIT with a cohort~     of matched historic control patients that were treated using standard of care will be~     conducted. It is planned to analyse 42 historic control sarcoma patients that will be matched~     for disease, recurrences, relapses etc.~   "
78923|NCT02533882|"~     This study will examine the effectiveness of two types of group exercise classes on the~     health and functional status in inactive adults age 18-65 with neurological conditions~     including Multiple Sclerosis, stroke, and spinal cord injury (SCI). Participants will be~     randomly assigned to one of three groups; Movement to Music, Adapted Yoga, or a waitlist~     group who will complete a home-based exercise intervention of either Movement to Music or~     Adapted Yoga.~   "
78924|NCT02533869|"~     This study focuses on the use of contrast enhanced low-dose CT imaging as a modality to~     differentiate between uncomplicated and complicated acute appendicitis. Differentiation~     between the two forms of acute appendicitis is important because according to recent studies~     their treatment differs. Complicated forms are still treated operatively, while uncomplicated~     forms can be treated conservatively with antibiotics. In the initial phase of the study,~     several optimized CT protocols will be created with a phantom model. The two best performing~     models will be selected for the second phase of the study, in which patients presenting with~     suspected acute appendicitis will be imaged with the two protocols. All patients~     participating in the study will be treated operatively, primarily with a laparoscopic~     appendectomy. Thus histological confirmation for the diagnosis can be achieved and compared~     with the CT images. The goal of this study is to optimize a well-performing low-dose CT~     imaging protocol to use in the diagnosis of uncomplicated acute appendicitis.~   "
78925|NCT02533856|"~     This is a randomized controlled trial to assess the relative effectiveness of providing~     Enhanced Transitions of Care (ETOC) to improve patient outcomes after discharge from the~     Emergency Department (ED). Patients who are being discharged from the ED and have had a~     previous ED visit or hospital admission within the Thomas Jefferson Hospital System (TJUH or~     Methodist) within the past 90 days will be eligible for enrollment in this trial. Patients~     who consent to enrollment will be randomized to discharge by usual care or discharge with~     ETOC as provided by the company BoardRounds.~   "
78926|NCT02533843|"~     Specific Aim: This prospective randomized study aims to compare the impact of three different~     catheter ablation approaches on long-term procedure outcome in terms of arrhythmia recurrence~     in persistent (PeAF) and long-standing persistent atrial fibrillation (LSPAF) patients. The~     three strategies to be evaluated are 1) ablation at sources guided by FIRMap (using~     RhythmView™ Workstation from TOPERA), 2) ablation at sources guided by FIRMap + conventional~     pulmonary vein antrum isolation (PVAI) and 3) Extended PVAI plus ablation of non-PV triggers~     and complex fractionated atrial electrograms (CFAE).~   "
78927|NCT02533830|"~     The aim of the present study was to evaluate the effect of chewing gum on the recovery of~     bowel function after cesarean section in women.~   "
78928|NCT02533817|"~     In the UK, people of black West African and Caribbean's tend to have healthier blood~     cholesterol and blood fat levels, as well as lower incidence of heart disease/heart attack.~     But rates of heart disease are now rising in young African-American populations with~     diabetes, for the first time exceeding the rate in their white European-American peers. One~     possible culprit is the increasing consumption of fructose which can lead to high blood fat~     levels. Fructose is a natural sugar found in fruits and table sugar but is also used the food~     industry as an ingredient and sweetener. Because fructose intakes are lower in the UK than in~     North America we are studying the effect of fructose intake in UK black West African and~     Caribbean people, to understand if fructose intake is indeed a reason for these ethnic~     differences.~   "
78929|NCT02533804|"~     The Lake Nona Life Project aims to examine the health and wellness of participants over the~     course of multiple years, focusing on the links between health and wellness, longevity,~     quality of life, and human performance.~   "
78930|NCT02533791|"~     Since its first outbreak occurred in 1976, Zaire Ebola virus have been associated with 14~     outbreaks reported up to 2014. The Zaire Ebola virus in 2014 causing the most serious~     outbreak was considered to be a new epidemic strain, with GP homology of the gene was only~     97.6%, compared to the GP gene of the strain in 1976. This investigational Ad5-EBOV vaccine~     was developed according to the 2014 epidemic Zaire strain and formulated as freeze-dry~     products which could be stored at 4℃.~      In 2014, a single center, double-blind, placebo control, dose-escalation phase 1 clinical~     trial was performed in Taizhou, China. Our findings show that the Ad5-EBOV vaccine is safe~     and robustly immunogenic. One shot of the high dose vaccine could mount glycoprotein-specific~     humoral and T-cell response against Ebola virus in 14 days. The investigators intent to~     evaluate the safety and immunogenicity of a booster dose of the recombinant Ebola adenovirus~     vector vaccine (Ad5-EBOV) in healthy adults after primary immunization in this add in study.~     The investigators expect that the boosting immunization with a same vaccine for primary~     immunization is possible and could confer a longer-lived protection when needed.~      The phase I trial has been unblind 28 days after the primary vaccination, but all the~     subjects are still kept blind as well as the laboratory staffs. Therefore, this booster~     vaccination trial will be conduct in single blind.~   "
78931|NCT02533778|"~     A prospective pilot study to evaluate the recanalization and safety of mechanical~     thrombectomy through a cerebral angiogram in patients with stroke symptoms last seen normal~     between 8 - 24 hours.~   "
78932|NCT02533765|"~     This is open-label, single-arm, two-stage phase II trial of olaparib in patients with~     relapsed/refractory metastatic germ cell cancer. The primary objective is to evaluate the~     preliminary activity of Olaparib in GCT tumors. The secondary objective is to evaluate the~     safety of Olaparib in patients with cisplatin-refractory GCT.~   "
78937|NCT02533700|"~     Peripheral T-cell Lymphoma (PTCL) is a heterogenic malignancy with poor outcome. Five-year~     PFS and OS for these patients received classic CHOP regimen (cyclophosphamide, vincristin,~     doxorubicin and prednisone) is less than 30%.High dose intensive chemotherapy doesn't~     demonstrate better response. At present, there is no standardized treatment protocol for this~     kind of lymphoma. So, clinical trials are encouraged by NCCN for those patients.~   "
78938|NCT02533687|"~     With this study, it is aimed to compare the operative results and complication rates in~     transurethral resection of the prostate (TUR-P) performed by resectoscopes with two different~     bipolar and a monopolar energy sources.~   "
78939|NCT02533674|"~     Prospective, open-label, dose-ranging, uncontrolled phase I study with escalating doses of~     PM060184 in combination with gemcitabine in selected patients with advanced solid tumors.~      The study objectives are:~      To determine the MTD and the RD of PM060184 in combination with gemcitabine in selected~     patients with advanced solid tumors.~      To characterize the safety profile and feasibility of this combination in this study~     population.~      To characterize the pharmacokinetics of this combination and to detect major drug-drug PK~     interactions.~      To obtain preliminary information on the clinical antitumor activity of this combination.~   "
78940|NCT02533661|"~     Accumulating data on early intervention for preterm infants in Western countries have~     demonstrated short- to medium-term benefits on enhancing child cognitive outcome.~     Furthermore, the cumulative plasticity of dopamine-related genes may interact with~     environmental intervention in influencing a child's behavior. However, rare studies have~     examined the long-term effect of early intervention for preterm infants in Eastern society~     and whether the genetic markers interact with environmental intervention in shaping child~     developmental outcomes. To meet the contemporary concept of family-centered intervention and~     to adapt the findings of our previous studies into program design, we have developed a~     family-centered intervention program (FCIP) for preterm infants with very low birth weight~     (VLBW, birth weight <1,500 g) in Taiwan and employed a multi-centered, randomized controlled~     study design to examine its short-term effects with respect to a usual care program (UCP) and~     its biosocial pathways.The FCIP contained ecologically pervasive child-, parent- and~     dyad-focused services that lasted from hospitalization until 12 months; the UCP contained~     child-focused services in hospitalization and phone calls after discharge. This three-year~     multi-centered study is therefore aimed to extend our research to examine the long-term~     effectiveness of FCIP on child and parent outcome compared to a usual care program (UCP) for~     VLBW preterm children in Taiwan at preschool age and to investigate if dopamine-related genes~     moderate intervention effect on child developmental outcome. A total of 270 VLBW preterm~     infants have been enrolled and randomly assigned to the FCIP and UCP, and their buccal cells~     samples have been collected for typing of dopamine-related genes. All infants and families~     will be examined at 3 and 4 years of age for child and parent outcomes. Child outcomes will~     include growth, health, cognition, language, motor function, and behavioral measures; parent~     outcomes will consist of parental stress and quality of life measures. The long-term effect~     of early intervention for preterm infants will provide important information to help~     medical/educational professionals and public policy makers develop and assess effective~     intervention for Taiwanese preterm children who are at risk of developmental disorders.~     Furthermore, the results will help reveal the gene and intervention interaction on child~     developmental outcome.~   "
78941|NCT02533648|"~     Our recent data in mice have demonstrated a key role of xanthine oxidase in~     hyperglycemia-induced by Reactive oxygen species production, and a preventive role of~     allopurinol (inhibitor of xanthine oxidase) on the keeping of mitochondria number and~     structure, in skeletal muscle of diabetic mice. The investigators want to initiate a clinical~     trial in order to evaluate the efficacy of allopurinol on the improvement of mitochondrial~     alterations, oxidative capacities and insulin sensitivity, in skeletal muscle of type 2~     diabetic patients.~   "
78942|NCT02533635|"~     This is a single-blind, cross-over pilot study to observe the safety and efficacy of~     Ganoderma tea on eczema patients.~   "
78943|NCT02533622|"~     Despite the known complications of immobility for ICU patients, compliance to mobility~     protocols is lacking in many institutions. Significant barriers have been described to~     compliance to up in chair and weight bearing orders in the ICU. Recent studies indicate that~     if progressive mobility is performed for acutely ill ICU patients they may have a reduced ICU~     length of stay, reduced overall hospital length of stay, incur lower hospital costs, and~     reduce the rate of some medical complications and increase functionality post ICU discharge.~      The current protocol seeks to understand whether or not the TotalCare® P500 Bed System and~     the Liko Lift can remove some of the barriers associated with progressive mobility~     compliance.~   "
78944|NCT02533609|"~     Acute kidney injury requiring renal replacement therapy is common in critically ill patients.~     The major causes of AKI are severe sepsis and septic shock requiring effective antibiotic~     treatment. Patients with sepsis on ICUs usually are haemodynamically instable so that renal~     replacement therapy is applied using continuous techniques. In recent years, the efficacy of~     renal replacement therapies has improved, namely by using regional citrate anticoagulation~     which improves filter lifetime and filter patency. At present, the extent of removal of~     antibiotic drugs using citrate-anticoagulated CVVHD in critically ill patients has not been~     investigated thoroughly. Thus, the investigators want to investigate~        1. whether and to what extent antibiotic drugs (piperacillin/tazobactam and~          imipenem/cilastatin) are removed during citrate-anticoagulated CVVHD per se~        2. whether filter patency during citrate-anticoagulated CVVD remains stable during a~          treatment period of 72 h~   "
78945|NCT02533596|"~     Therapeutic plasma exchange (TPE) is an established treatment modality for the acute removal~     of pathophysiological relevant mediators in various diseases. Adipokines have recently been~     found to play an important role in a variety of immunologic diseases. However, in many of~     these disease states cardiac and inflammatory involvement is common and biomarkers are~     routinely used for diagnosis or assessment of therapeutic success. The effect of TPE on~     biomarkers used in the clinical routine has not been investigated. The aim of this study is~     to determine adipokine and cardiac biomarker removal during TPE therapy.~   "
78946|NCT02533583|"~     The investigator assessed the feasibility and reliability of pulse oximetry plus clinical~     observation for detection the lung disease in neonates.~   "
78947|NCT02533570|"~     The purpose of this study is to evaluate the safety and tolerability of brentuximab vedotin~     in adults with active systemic lupus erythematosus (SLE).~   "
78948|NCT02533557|"~     The supraclavicular block can provide effective surgical anesthesia of the forearm and hand.~     There have been many different approaches to ultrasound-guided supraclavicular brachial~     plexus block (US-SCBPB) according to the needle injection site (e.g. corner pocket approach,~     cluster approach) or number of needling (single or double injection). Numerous studies~     demonstrates good results (e.g. faster onset time) when using double injections rather than~     single injection. But double injection does not guarantee complete sensory block because~     ulnar nerve tends to be spared by its anatomical location.~   "
78949|NCT02533544|"~     This is an open-label, single arm cohort study to see efficacy and safety of tenofovir~     disoproxil fumarate (TDF) in naïve chronic hepatitis B, retrospectively and prospectively~     both.~   "
78951|NCT02533518|"~     Diagnose lung cancer at an early stage is crucial for effective treatment. At these early~     stages, cancer is usually invisible in ambient white light when the endoscopic analysis of~     the bronchial mucosa. This lining is self-fluorescent at its illumination by blue light.~     These widely distributed autofluorescence methods detect early mucosal abnormalities. They~     are very sensitive but not specific to recognize the lung cancer. Thanks to European funding~     (EURIMUS), a new tool with fluorescent UV light has been developed.~      The purpose of this preliminary study is to verify the suitability for specific detection of~     cancerous tissue in Pneumology of this fluorescence method versus histological analysis of~     the tissue.~   "
78952|NCT02533505|"~     A Phase IV study evaluating changes in oxygen consumption and cardiac function in Subjects~     with Chronic obstructive pulmonary disease (COPD) with resting hyperinflation after~     administration of Symbicort pMDI 160/4.5 μg.~   "
78953|NCT02533492|"~     Total knee replacement is now one of the most popular reconstructive procedures for the~     elderly people to regain their functional capacity and life quality. However the reported~     incidence of postoperative infection or surgical site infection after total knee replacement~     has been around 1 to 2 percent. The cost and expenditure for treating periprosthetic~     infection are high and the results are often detrimental to the patients who suffered from~     the complication. To decrease the wound healing complication related to the contamination of~     bacteria, an antibacterial suture was used successfully in some clinical settings and in~     animal experiments. Whether the antibacterial suture material could be used in patients with~     total knee replacement has not been addressed in the past. The investigators therefore~     propose a prospective randomized double-blinded study to investigate the efficacy of an~     antibacterial suture material in total knee replacement. The inclusion criteria are patients~     with degenerative osteoarthritis without previous surgery to the index knee. Patients who~     have inflammatory arthritis such as rheumatoid arthritis, who have neurovascular disease of~     the lower extremities, who have history of liver cirrhosis or under hemodialysis for renal~     failure are excluded. One hundred and two patients will be randomized to study group (51~     knees) and control group (51 knees) in a period of 12 months. All cases will follow the~     standard protocol based on clinical pathway. Antibacterial suture material (Vicryl Plus,~     Ethicon) will be used in the study group and regular suture material (Vicryl, Ethicon) will~     be used in the control group. Preoperatively, the skin condition (digital photo and image~     analysis),laser Doppler study, inflammatory markers (CRP/ESR/IL-6), functional score (KSS:~     Knee Society Score; SF-12: Short Form 12), and VAS score will be assessed. Operative data of~     operation time, blood loss and wound classification are recorded. Postoperatively, the skin~     condition (digital photo and image analysis), skin temperature, inflammatory markers, KSS,~     and VAS will be assessed on 1st and 3rd postoperative day, 2 weeks, 4 weeks, and 3 months.~   "
78954|NCT02533479|"~     The aim is compare and correlate skeletal muscle and erythrocytes fatty acids (FAs) profiles~     in adult healthy human after caloric restriction and acute exercise in order to validate~     erythrocyte FAs profile as marker of changes in muscle fatty acid composition.~   "
78955|NCT02533466|"~     This exploratory study is designed to help develop a clinical model to measure the earlier~     stages of dietary acid medicated enamel loss. The study will use fluoride as positive control~     to explore the validity of this design.~   "
78956|NCT02533453|"~     As current study is conducted to provide additional information regarding safety and efficacy~     Bydureon, exenatide once weekly for injectable suspension, in the Korean population open~     label, non-comparative, multi-centre design is used.~   "
78957|NCT02533440|"~     This study is researching managing postsurgical pain by injecting both short-acting local~     anesthetics and EXPAREL® at the time of surgery and reviewing if it could reduce or eliminate~     the need for postsurgical opioids and improve clinical outcomes following the FAST dental~     implant surgery procedure. This approach is being compared to the current standard of care.~   "
78958|NCT02533427|"~     This study will evaluate the effect of sofosbuvir (SOF)/velpatasvir (VEL)/GS-9857 fixed-dose~     combination (FDC) + GS-9857 on the pharmacokinetics (PK) of a representative hormonal~     contraceptive medication, norgestimate/ethinyl estradiol (Ortho Tri-Cyclen® Lo (OC)) and will~     assess the effect of norgestimate/ethinyl estradiol on the PK of SOF/VEL/GS-9857+GS-9857.~   "
78959|NCT02533414|"~     In this study, it is aimed to evaluate whether use of a ureteral access sheath (UAS) during~     retrograde intrarenal surgery (RIRS) due to kidney stone has any effect on protecting the~     kidney functions by measuring blood and urine and Netrin-1 levels.~   "
78960|NCT02533401|"~     This study will evaluate the efficacy and safety of rituximab in combination with~     chemotherapy (fludarabine and cyclophosphamide) in participants with B-cell CLL.~   "
78961|NCT02533388|"~     Elderly patients have an increased risk of stress responses during extubation after general~     anaesthesia for an elective supratentorial craniotomy. How to decrease the stress responses~     during extubation after general anaesthesia remains challenging for the anaesthesiologist. In~     this study, we aimed to investigate whether transcutaneous electrical acupoint stimulation~     (TEAS) might decrease the stress responses and improve the quality of recovery in the elderly~     patients who underwent elective supratentorial craniotomy under general anaesthesia.~   "
78962|NCT02533375|"~     The primary objective is to investigate efficacy, safety and pharmacokinetics of adalimumab~     in Japanese subjects with generalized pustular psoriasis (GPP).~   "
78963|NCT02533362|"~     A 6 month safety, tolerability, efficacy and pharmacokinetic study with ANF-Rho to treat~     patients with chronic neutropenia.~   "
78964|NCT02533349|"~     Based on meta-analysis of prokinetics trials in laryngopharyngeal reflux disease (LPRD)~     (Glicksman et al. 2014), well designed study was performed in 4 articles. But, those studies~     had several problems including inclusion criteria, randomization methods, and placebo~     medication. They had similar results that prokinetics and proton pump inhibitor (PPI) had~     synergistic effect for management of LPRD. Therefore, the aim of study is to evaluate the~     efficacy of prokinetics as an additional medication to proton pump inhibitor by well designed~     randomized double blind case-control study.~   "
78965|NCT02533336|"~     Over one year period in an area with universal coverage of LLIN and ACT provision as the~     first-line treatment of malaria, the investigators intend to evaluate the impact of DL on~     malaria transmission as measured by the incidence of malaria parasitemia, the prevalence of~     moderate to severe anemia, and entomological parameters. Information on the relative~     cost-effectiveness estimates of DL and the community acceptability of DL will also be~     measured.~   "
78966|NCT02533323|"~     This prospective study was conducted to evaluate the efficacy and safety profiles of~     first-line combined gemcitabine, oxaliplatin, and Pegaspargase (P-Gemox) in newly diagnosed,~     nasal type, extranodal natural killer/T-cell lymphoma.~   "
78967|NCT02533310|"~     The aim of this study is to examine the efficacy of virtual reality exposure therapy as a~     treatment for specific phobia (spiders). A gamified virtual reality simulation of one-session~     therapy (VR-OST) will be compared to the gold-standard treatment in the form of traditional~     one-session phobia treatment (OST) using in-vivo stimuli. This study was powered to detect a~     non-inferiority margin of a 2-point difference between groups.~   "
78971|NCT02533258|"~     This is a post-marketing Surveillance study to observe INLYTA® treatment dosing pattern,~     safety and effectiveness in Taiwan real world routine practice. The primary objective of this~     registry is to monitor the dose adjustment of INLYTA® in real world routine practice. The~     secondary objectives include safety profile, objective response rate, and progression-free~     rate in real world routine practice.~   "
78972|NCT02533245|"~     The primary aim is to evaluate the short- and long-term effect of the 'Transplantoux'~     exercise training intervention in solid organ transplant recipients with matched control~     sample of transplant recipients in view of selected Patient Reported Outcomes (PRO), i.e.~     health-related quality-of-life (HRQOL), psychosocial and behavioral variables, using a~     quasi-experimental design.~   "
78973|NCT02533232|"~     This a randomized double-blind placebo controlled trial which aims to determine the~     beneficial effects of minocycline augmentation to clozapine in partial responders to~     Treatment Resistant Schizophrenia (TRS).~   "
78974|NCT02533219|"~     The primary objective of this study is to evaluate the utility of [18F]-DOPA PET to provide~     improved presurgical planning and distinguish between focal and diffuse forms of HI. The~     investigators will perform descriptive analysis, relying on visual analysis to diagnose and~     localize a focal lesion. Our findings will be compared to surgical histopathology to~     determine sensitivity and specificity or this technique. The investigators will also track~     patient surgical outcomes, specifically whether the patient is surgically cured or still~     requires medical management to control residual hypoglycemia.~   "
78975|NCT02533206|"~     Chronic sinusitis is one of the most common chronic diseases in North America, with over 5%~     of the Canadian population affected by the disease. Until now, treatment with surgery has~     been performed only in the operating room. Recently a smaller surgical procedure that is done~     in the clinic for some patients with chronic sinusitis with polyps has been found to result~     in symptom control that appears to be similar to that which occurs with sinus surgery.~     Performing the smaller clinical procedure has advantages including a shorter recovery time~     for the patient, a much lower cost to the health care system for the procedure, and a shorter~     patient wait time for the procedure to be done in comparison to sinus surgery performed in~     the operating room. To know with greater certainty that the procedure performed in the clinic~     is as good as the operating room sinus surgery, a large multiple investigator randomised~     clinical trial has been designed. However, before carrying out that trial, a practice run or~     internal pilot study of that trial is required to ensure that the trial can recruit patients~     at the rate that is anticipated and that the procedures to obtain the measurements being used~     for the larger study are adequate.~   "
78976|NCT02533193|"~     The purpose of this study is to investigate the clinical value of enhanced recovery after~     surgery protocal in laparoscopic hepatectomy by assessing its outcomes and hospital stay days~     comparing with traditional care .~   "
78977|NCT02533180|"~     The primary aim of this study is to determine whether a peripheral blood or graft lymphocyte~     phenotype of immune senescence or exhaustion is different between operationally tolerant and~     non-tolerant liver allograft recipients.~   "
78978|NCT02533167|"~     Early skin to skin contact has beneficial effects and is part of the Healthy Birth~     Initiative. Positive effects on breast feeding, cardiorespiratory status, blood glucose~     control, and temperature has been demonstrated. It is the standard of care for vaginal~     deliveries but surgery is a barrier in its initation in the operating room. This study is~     evaluating initiating skin to skin contact as soon as feasible in the operating room.~     Informed consent will be obtained from scheduled/non emergent cesarean sections who are of~     EGA.37 weeks who are ASA I-II and receiving the standard spinal anesthetic. Skin to skin~     contact will be initiated after delivery as soon as apgars and newborn assessment has been~     completed. Goal is a minimum of 60 minutes of skin to skin contact between the mother and the~     newborn, with the only interruption being upon movement from the OR table to the stretcher~     when leaving the OR. Subjects seen post delivery day 1 for assessments of pain and maternal~     satisfaction utilizing a sliding 100mm VAS assessment tool.~   "
78979|NCT02533154|"~     Benzalkonium chloride (BAC) is a preservative, which is a component of more than 70% of~     topical ophthalmic drugs. Although BAC is a preservative with an excellent antibacterial~     spectrum, it has also been shown to induce toxic effects to the ocular surface. Several~     studies have indicated that BAC may also have altering effects on the bacterial flora of the~     conjunctiva.~      Since dry eye syndrome (DES) is a very common and multifactorial disease of the ocular~     surface and the tear fluid resulting in tear film instability, inflammation of the ocular~     surface, symptoms of discomfort and visual impairment, there are many different preserved as~     well as preservative-free ophthalmic preparations of ocular lubricants for the treatment of~     DES. Unpublished data from our department shows differences between artificial tears for the~     treatment of DES with and without BAC in bacterial culture.~      Therefore, the aim of this study is to investigate the effect of artificial tear eyedrops~     with and without BAC on the conjunctival bacterial flora. For this 40 patients with mild or~     moderate dry eye syndrome with no use of artificial tears in the 4 weeks preceding the study~     will be recruited and treated either with the preservative-free Prosicca sine eyedrops or~     the BAC containing Prosicca eyedrops for one month. Conjunctival samples will be collected~     of one eye of each patient before and after the 1-month treatment period to compare the~     conjunctival bacterial flora of the two treatment groups.~   "
78987|NCT02533050|"~     The presence of Obstructive Sleep Apnea Syndrome (OSAS) has a high frequency in patients~     victims of a coronary artery disease (CAD) (myocardial infarction, revascularization). Unlike~     patients seen in a sleep Laboratory with an impact on daytime functioning, CAD apneic~     patients do not complain in their daytime functioning. The objective of this study is to~     explore whether the objective cognitive assessment measures may be a good marker of the~     efficacy of CPAP treatment given to non-sleepy apneic CAD patients.~      Coronary patients with an AHI between 15 and 40 / h will be treated (or not) after~     randomization with CPAP treatment. The expected results are: CPAP apneic coronary patients~     should have a positive impact on cognitive performance, particularly on attention span and~     working memory measured by improvement in the Paced Auditory Serial Addition Test score~     (PASAT score).~   "
79116|NCT02531347|"~     The purpose of the study is to compare antihypertensive treatment based on either~     conventional blood pressure measurements or telemedical home blood pressure measurements.~      Hypothesis is that telemedical treatment of hypertension is more effective in lowering blood~     pressure, is more cost-effective and provides better quality of life.~   "
78980|NCT02533141|"~     Statins are drugs representing the most commonly prescribed medication for the treatment of~     hypercholesterolemia. In a recently published study, discontinuation of statin therapy in~     patients after acute myocardial infarction was associated with a higher all-cause mortality~     (hazard ratio 3,45) and a higher cardiac mortality (hazard ratio 4,65). Increasing evidence~     suggests that statins also have vasoactive properties by up-regulating endothelial nitric~     oxide synthase (eNOS) with positive effects on endothelial function. Experiments with~     flow-mediated vasodilatation (FMD) showed these positive effects of statin treatment on~     endothelial function but also revealed that withdrawal of statin treatment transiently~     worsens endothelial function, independently of serum cholesterol levels.~      Consequently, this placebo controlled Phase IV crossover study wants to assess changes of~     endothelial function in terms of flicker induced vasodilatation before and during statin~     therapy as well as after statin withdrawal. For this purpose 20 healthy subjects will be~     treated with 40 mg/day of simvastatin for a period of 4 weeks. Flicker induced vasodilatation~     and retinal oxygen saturation will be measured with the Dynamic Vessel Analyzer system by~     Imedos at baseline, in the 4th week of simvastatin or placebo intake as well as 3, 7 and 14~     days after the end of intake.~   "
78981|NCT02533128|"~     Major adverse cardiovascular events (MACE) are a leading cause of serious complications and~     death following major noncardiac surgery. The heart biomarkers brain-type natriuretic peptide~     (BNP) and high-sensitivity troponin I/T (hs-TnI/T), may aid in estimating the risk of surgery~     - low values may permit identifying patients at a very low risk of postoperative~     complications, potentially helping to avoid unnecessary tests and delays prior to surgery.~      Recent studies suggest that the manner in which an anesthetic is conducted may have an~     important impact on postoperative outcomes. The combination of low blood pressure (BP) and a~     deep level of anesthesia despite a low dose of anesthetic - also known as a triple low -~     has been linked to increased complications and death following surgery. However, it is~     unclear whether triple lows actually cause postoperative complications or whether they are~     merely an indicator of a sick patient, who is in general more likely to suffer from~     cardiovascular events in the near future. To answer this question, in this study patients~     will be randomly assigned to groups with lower and higher blood pressures, and the~     postoperative rates of major adverse cardiovascular events and of relevant increases in~     hs-TnI (a marker of cardiac injury) compared.~      Another important question is that of the optimal blood pressure target during surgery.~     Currently there are no established methods of tailoring blood pressure management to the~     individual patient. In the study the investigators will perform ambulatory 24h BP~     measurements prior to surgery to measure the patients' average BP during sleep. In the~     analysis of the study data, the investigators will try to determine the relationship of~     preoperative biomarker levels, intraoperative BP (both in relation to fixed targets and to~     the patient's own night-time BP) and of anesthetic depth with the occurrence of major adverse~     cardiovascular events after surgery.~   "
78982|NCT02533115|"~     This study is a Phase IV Expanded Access Protocol (EAP) of CPX-351 in patients with secondary~     acute myeloid leukemia who are suitable for treatment with intensive chemotherapy.~   "
78983|NCT02533102|"~     This study is designed to first evaluate the effect of food on E7050's pharmacokinetic~     parameters following the administration of single 100 mg oral doses of E7050 tablet to each~     normal healthy participant in the study (Part A), and second to characterize E7050~     pharmacokinetics after single doses at 200 mg and 400 mg under fasted conditions (Part B).~     Part A will be a randomized, single-dose, open-label, three-treatment period crossover study.~     Part B is a nonrandomized, open-label, two-treatment sequential study design. Twelve~     participants in Treatment Period 1 will receive a single dose of 200 mg of E7050 under fasted~     conditions. Following review of safety data of the 200 mg dose level, an additional 12~     subjects will then receive a single dose of 400 mg of E7050 in Treatment Period 2.~   "
78984|NCT02533089|"~     Task shifting of less complex healthcare tasks to lay health workers (LHWs) is increasingly~     employed strategy to address the global shortage of skilled health workers. Despite~     availability of effective treatment, tuberculosis (TB) remains an important cause of~     mortality with 1.3 million lives lost globally to TB in 2012. The greatest proportion of new~     TB cases occurs in Africa and over 95% of TB deaths occur in low income countries (LICs). In~     response to the combined high TB burden and severe healthcare worker shortages in these~     settings, outpatient TB care is among the tasks commonly shifted to LHWs.~      LHWs are community members who have received some training but are not healthcare~     professionals. Randomised trials show LHWs improve access to basic health services and TB~     treatment outcomes, however, insufficient training and supervision are recognized barriers to~     their effectiveness.~      The investigators' goal is to improve TB care provided by LHWs in Malawi by implementing and~     evaluating a knowledge translation (KT) strategy designed to facilitate incorporation of~     evidence into LHW practice. The investigators will employ a mixed methods design including a~     pragmatic cluster randomized controlled trial to evaluate effectiveness of the strategy and~     qualitative methods to understand barriers and facilitators to scalability and sustainability~     of the program.~   "
78985|NCT02533076|"~     Cystinosis is a rare autosomal recessive disorder, characterized by the abnormal accumulation~     of cystine in the lysosomes. Cystinosis is mostly caused by mutations in the cystinosin gene~     (CTNS). The major mutation, which is present in almost 50% of the cystinosis patients, is a~     57-kb deletion. This deletion removes the first 9 exons and a part of exon 10 of the CTNS~     gene. Exon 10 of the CTNS gene is a upstream 5' region that encodes for the CARKL gene and~     also for the first two noncoding exons of the transient receptor potential channel, vanilloid~     subfamily member 1 (TRPV1) gene.~      TRPV1 belongs to the transient receptor potential (TRP) superfamily of cation channels. TRPV1~     is primarily expressed in sensory nerves and is activated by heating (>43°C) and a wide range~     of chemical stimuli. One of these chemical stimuli is capsaicin, the pungent ingredient in~     hot chilli peppers. The effect of binding of the exogenous ligand capsaicin with the TRPV1~     receptor is well known to provoke the release of a number of bioactive substances including~     calcitonin gene-related peptide (CGRP). These substances, in turn, act on target cells in the~     surrounding tissue such as mast cells, immune cells and vascular smooth muscle cells. The~     resulting response is characterized by redness and warmth (secondary to vasodilatation),~     swelling (secondary to plasma extravasation) and allodynia (i.e. hypersensitivity to heat and~     touch secondary to alterations in the excitability of primary sensory neurons).~      The present study wants to test the following hypotheses:~      (i) The DBF response to topical applied capsaicin is decreased in cystinosis patients,~     compared to matched control subjects.~      (ii) The skin sensitivity response after topical applied capsaicin is decreased in cystinosis~     patients, compared to matched control subjects.~      (iii) The temperature sensitivity is decreased in cystinosis patients, compared to matched~     control subjects.~   "
78986|NCT02533063|"~     This proposed prospective study will evaluate whether a novel exercise approach, seated~     vibration therapy, can improve function in the target population of older adults. Therefore,~     the primary aim of this pilot is to examine the effect of vibration therapy on muscle~     function (balance, muscle power and strength) and muscle mass.~   "
78998|NCT02532907|"~     This study is designed to obtain and store samples of serum and liver tissue in HCV (HepC~     Virus)-infected patients being treated with direct-acting antiviral (DAA) therapy, and to~     determine the effect of new DAA therapies on HCV-related responses in the liver and~     peripheral blood.~      The introduction of new DAAs regimens that do not include IFN provides unique and novel~     opportunities to examine whether successful treatment-induced eradication of viral antigen~     results in reconstitution of T cell immunity. serum and liver tissue samples will be~     collected and stored in hopes of improving treatment and outcomes for future patients.~   "
78988|NCT02533037|"~     This is a randomized controlled trial (RCT) regarding the conservative treatment of chronic~     ankle instability (CAI) with an impairment based rehabilitation program. Individuals with CAI~     have deficits in neuromuscular control and altered gait patterns. Ankle destabilization shoes~     are used clinically and may improve neuromuscular control by increasing lower extremity~     muscle activation, which may improve gait patterns. The investigators' purpose is to~     determine whether a 4-week rehabilitation program that includes ankle destabilization shoes~     (experimental) has beneficial effects on self-reported function and ankle gait kinematics~     compared to traditional rehabilitation without destabilization shoes (control) in CAI~     patients. In addition, the investigators will compare ankle strength and balance between CAI~     patients and healthy individuals with no history of ankle injury prior to the 4-week~     rehabilitation. The investigators hypothesize the experimental group will have greater~     improvement in self-reported function and frontal and sagittal plane kinematics during~     walking compared to the control group. In addition, the investigators hypothesize that~     patients with CAI will have a decrease in ankle strength and balance when compared to healthy~     individuals. The design is a single-blinded randomized controlled trial. Forty CAI patients~     will complete baseline self-reported function questionnaires and walking gait trials and then~     be randomized into control and experimental groups. Both groups will complete 4-weeks of~     supervised rehabilitation with or without destabilization shoes and then repeat the~     questionnaires and walking trials.~   "
78989|NCT02533024|"~     This study is to investigate the incidence of undiagnosed ulnar neuropathy in patients~     undergoing surgery. The investigators hope to determine if patients with ulnar neuropathy~     have changes in nerve conduction latency during surgery.~   "
78990|NCT02533011|"~     Present criteria used to define sepsis are non-specific, making it difficult to both~     distinguish sepsis from other diseases and to predict which patients are likely to become~     more severely ill. In standard care, patients at risk of becoming more severely ill are~     neither identified nor indicated for resuscitative efforts until they develop hemodynamic~     insufficiency or organ failure; after progression to severe disease, mortality increases~     significantly. The identification of risk patients can lead to earlier initiation of~     resuscitation therapies and potentially lead to reduced morbidity and mortality. This study~     aims to determine whether Heparin-binding protein (HBP), which is secreted from neutrophils~     during infection and a mediator of vascular leakage, can act as a biomarker for the~     progression to severe sepsis with circulatory failure.~      The objective of this study is to validate the utility of HBP to predict the development of~     delayed onset organ dysfunction in sepsis in patients and to compare the performance of HBP~     relative to currently used prognostic biomarkers in sepsis.~   "
78991|NCT02532998|"~     This is a Phase I, Randomized, Single-Blind, Crossover Study to Assess the Pharmacodynamics~     of AZD9977 following Single-Dose administration to healthy male subjects~   "
78992|NCT02532985|"~     The study will assess the gastrointestinal tolerability of multiple servings of a novel~     dietary fiber at three different dose levels in generally healthy men and women. Double-blind~     controlled, cross-over clinical trial with negative (no added fiber) and positive controls.~     Multiple servings over 24h, with data collection at 24 and 48h and 1 week wash-out between~     cross-overs. 45 randomized, generally healthy men and women, 18-54 y, BMI higher or equal to~     18.5 and smaller or equal to 39.99 kg/m2. Novel dietary fiber ingredient and positive control~     will be delivered in 240 ml beverages.~   "
78993|NCT02532972|"~     This is a research study to determine whether a cochlear implantation (CI) device can improve~     hearing in people who are deaf in one ear (known as single-sided deafness).~   "
78994|NCT02532959|"~     Analysis of exhaled breath samples using a high-speed gas chromatography medical device will~     identify Volatile Organic Compounds (VOC) that are specifically associated with SIRS and~     Sepsis.~      Primary outcome measures will include the assessment of the zNose Diagnostic Breath Analysis~     System, which includes high-speed gas chromatography, in the early detection of SIRS and~     Sepsis as compared with current SIRS and Sepsis evaluation methods.~   "
78995|NCT02532946|"~     This is a mixed methods study, incorporating a randomized controlled trial and a qualitative~     provider focus group, to evaluate contraceptive counseling aided by www.Bedsider.org in~     patients seeking first-trimester abortion. The primary outcome is the uptake of long-acting~     reversible contraception in women seeking induced abortion.~   "
78996|NCT02532933|"~     The overall purpose is to compare the kinematics and mechanics of medialized dome and~     anatomic resurfacing through measurement and simulation, and to correlate these findings with~     patient satisfaction and performance.~      Aim 1: Comparison of patellofemoral kinematics between dome and anatomic implant designs~     using stereo radiography and correlation with patient function as measured by Knee injury and~     Osteoarthritis Outcome score, Knee Society score, and strength.~      Hypothesis: the anatomic patellar implant will have significantly greater sagittal flexion~     than the dome implant.~      Aim 2: Comparison of dome and anatomic moment arm, quadriceps efficiency, patellar contact~     mechanics and loading through the use of subject-specific simulation.~      Hypothesis: quadriceps efficiency and moment arm will be greater for the anatomic patellar~     implant, while loading between the patellar and femoral components will be reduced.~   "
78997|NCT02532920|"~     Atopic dermatitis(AD) is one of manifestation in atopic march. The prevalence of AD is~     increased. In 1998, the investigators found the prevalence of AD about 15 % in Thailand. AD~     is diagnosed by clinical as Hanifin and Rajka criteria. There are 3 group of severity defined~     by SCORAD(Scoring Atopic Dermatitis) : mild (<25), moderate (25-50) and severe (>50). The~     natural history of AD was mentioned in 3 groups: complete remission, persistent and~     intermittent. Atopic march is the progression of atopic disease that has atopic dermatitis as~     the first manifestation then patients will have allergic rhinitis or asthma in the future.~     The investigators do a retrospective study to understand the natural history of AD as well as~     it associate with atopic march. That might be a predictive factor of AD and atopic march~   "
79024|NCT02532569|"~     A multi-center, open, phase 4 clinical trial to assess the long-term immunogenicity and~     safety of fourth administration of Boryung Cell-Culture Japanese Encephalitis Vaccine inj.~     and to conduct an exploratory investigation on vaccine interchangeability in Korean children~     aged 6 years who received primary 3 doses with ENCEVAC® or Japanese Encephalitis Vaccine-GCC®~     inj.~   "
78999|NCT02532894|"~     We plan to investigate the acute effects of inhaling e-cigarette vapor on cell function~     measured by microvesicles and endothelial progenitor cells. Micro vesicles are released upon~     either activation or apoptosis from different cell types such as platelets, leucocytes and~     endothelial cell. Endothelial progenitor cells are a type of stem cells that circulate in the~     blood with the ability to differentiate to endothelial cells. Endothelial progenitor cells~     are inversely correlated to cardiovascular risk factors.~      As a secondary endpoint we plan to investigate exhaled nitric oxide - a common inflammation~     marker used in asthmatic patients - after inhalation of electronic cigarette vapor.~   "
79000|NCT02532881|"~     The purpose of this study is to determine the effect of an internet-based preparation on the~     outcome expectancy and treatment credibility of rehabilitants concerning inpatient~     psychosomatic rehabilitation. Both study groups receive the usual written information for~     preparation (TAU). The patients of the experimental group have access to various videos on~     the study website until their inpatient rehabilitation begins, the patients of the placebo~     group receive no special treatment. The investigators hypothesize that the experimental group~     gains more positive outcome expectancy and treatment credibility compared to the control~     group.~   "
79001|NCT02532868|"~     The purpose of this study is to assess the safety and tolerability of MK-0457(VX-680), an~     Aurora kinase inhibitor, in participants with advanced solid tumors. Bioavailability of the~     oral formulation will also be assessed. The primary study hypothesis is that administration~     of MK-0457 is sufficiently safe and tolerated to permit further study.~   "
79002|NCT02532855|"~     The purpose of the study is to assess the effect of the addition of sitagliptin to metformin~     with or without a sulfonylurea compared with the addition of dapagliflozin to metformin with~     or without a sulfonylurea on hemoglobin A1c (A1C) over 24 weeks of treatment as well as the~     overall safety and tolerability of sitagliptin in comparison to that of dapagliflozin after~     24 weeks of treatment. The primary hypothesis is that the change from baseline in A1C in~     participants treated with the addition of sitagliptin is non-inferior compared to that in~     participants treated with the addition of dapagliflozin after 24 weeks of treatment.~   "
79003|NCT02532842|"~     The primary objective of this study is to explore hospitalization (number, length and reasons~     for psychiatric hospitalizations) in young, adult, newly diagnosed schizophrenia participants~     during the first 12 months of treatment with once monthly paliperidone palmitate in~     naturalistic clinical settings.~   "
79004|NCT02532829|"~     The HIPER-1 study is a single centre cross sectional study in which a total of 240~     participants (in different metabolic states and surgical models) will receive an Oral Mixed~     Meal Tolerance Test (OMTT). At baseline and after 30, 60 and 120 minutes the PYY levels,~     GLP-1 levels, glucose and insulin sensitivity will be measured. The primary endpoint of the~     study will be the area under the GLP-1 and Peptide - YY curves and insulin sensitivity~     following the OMTT.~   "
79005|NCT02532816|"~     The purpose of this study is to determine and compare the effect of higher nutrient-dense~     complementary foods and standard nutrient dense complementary foods on the catch-up growth~     and nutritional status of stunting children aged 12-23 months old in Indonesia.~   "
79006|NCT02532803|"~     Early cancers of the rectum can be removed safely through the anus without subjecting~     patients to major abdominal surgery in a procedure called TEMS (transanal endoscopic~     microsurgery). Patients undergoing TEMS can benefit from reduced mortality, impotence,~     hospital stay and avoiding a stoma that may be associated with pelvic surgery.~      Currently few of the patients eligible for TEMS are offered it for a variety of reasons that~     include uncertainties about the risk of leaving residual tumour and the increased risk of~     subsequent recurrence of cancer within the pelvis. Current UK guidelines state there is no~     role for imaging in assessing the malignant polyp. Conversely whilst retrospectively~     reviewing their MRI databank the investigators have found evidence that MRI can accurately~     judge the depth of these early tumours and thereby potentially identify patients for local~     excision.~      The investigators hope to prospectively test their hypothesis that an MRI scan can accurately~     gauge depth of tumour spread in an unselected group of benign and malignant tumours measuring~     between 20mm and 50mm in size.~      The investigators will identify eligible patients awaiting surgery / polypectomy and if they~     consent to this pilot study participants will undergo an MRI to assess their tumour which~     assesses safety at all levels of the rectal wall. The accuracy of MRI can then be established~     by reference to gold standard histopathology. Should MRI prove sensitive and specific then~     the investigators hope to change national guidelines to mandate MRI to standardise assessment~     and thereby increase the appropriate use of TEMS in the UK.~   "
79007|NCT02532790|"~     This study is performed to evaluate the efficacy and safety of various measures in the~     treatment of HSPN with mild proteinuria in children.~   "
79008|NCT02532777|"~     This study is performed to evaluate the efficacy and safety of various measures in the~     treatment of HSPN in children.~   "
79009|NCT02532764|"~     A randomized, double-blind, placebo-controlled study of single and multiple ascending doses~     of QR-010 in adults homozygous for ΔF508 Cystic Fibrosis.~   "
79010|NCT02532751|"~     The aim of this study is twofold; 1) to assess the psychometric properties of the Finnish~     version of the BODY-Q questionnaire, 2) to assess the effects of body contouring surgery~     using patient-reported outcome measures.~   "
79011|NCT02532738|"~     The investigators' preliminary study indicates that MSC is effective therapy in treating IBD.~     But the standard treatment is still lacking and the effect is not stable in IBD patients.~     This study is to explore the efficacy and standard strategy when using MSC in refractory IBD.~   "
79025|NCT02532556|"~     Blood is aided on its journey to the heart by the action of the muscles of the legs. Muscle~     contraction squeezes the deep veins of the leg and pushes blood upwards, back towards the~     heart. In immobilised patients, or those with blood vessel problems, the pumping process can~     be helped by machines that either squeeze or shock the muscles of the calf (e.g. intermittent~     pneumatic compression, electrical stimulating devices). Many are licensed for medical use,~     and some are common place in hospitals and outpatient departments.~      Objective: The most efficient way of electrically stimulating the calf muscles has not been~     identified. The investigators aim to investigate this using a matrix of electrical~     parameters, and measuring the outcome with vascular ultrasound of the leg.~   "
79012|NCT02532725|"~     Obesity is associated with many undesirable health effects and disease, and middle age is~     associated with increased risk for disease. Unfortunately, while others have looked at the~     effects of obesity, gender, and middle age, the combined effects of obesity and middle age on~     men's ability to do work in hot industrial environments have not been satisfactorily~     investigated.~      This small study evaluates the heat tolerance of lean and obese middle aged men both while~     exercising and resting and the ways in which each compensate for and dissipate increasing~     environmental heat and heat generated by the body while exercising.~      As obesity is a worldwide public health crisis and as populations in many industrialized~     nations age, it is important to understand the combined effects of obesity and middle age for~     men on their ability to safely work in hot environments. Such information will permit~     establishing and revising of safe work standards and inform public health outreach to the~     target population, itself.~   "
79013|NCT02532712|"~     This study is a Dose block-randomized, Double-blind, Placebo-controlled, Single and Multiple~     Ascending Dose Escalation, Phase I clinical trial to assess the safety, tolerability and~     pharmacokinetics of single-dose and multiple-dose oral administration of the investigational~     product, EC-18 (study drug) in healthy adult male volunteers.~   "
79014|NCT02532699|"~     This the first report undertaken to assess the effect of supplementation with oral~     gamma-aminobutyric acid (GABA), adenosine and antrosterol-containing AC mycelia on blood~     pressure among people with mild hypertension. Overall, AC mycelia consumption for 8 weeks~     could successfully reduce mean diastolic and systolic BP through the suppression of PRA that~     is linked to downstream suppresion of angiotensin II formation, which further decreases the~     sympathetic outflow that leads to hypertension. In addition to blood pressure lowering~     properties, AC mycelia also has beneficial effect in reducing oxidative stress,~     significantly. No adverse events were noted, suggesting that AC mycelia deserve its~     consideration as a candidate for safe alternative treatment to conventional anti-hypertensive~     medications.~   "
79015|NCT02532686|"~     Pharmacotherapy for schizophrenia has limitations such as residual positive and negative~     symptoms, cognitive deficits and intolerable side effects. Refractory schizophrenia is still~     a difficult clinical issue at present. According to the N-methyl-D-aspartate (NMDA)~     hypothesis, adjuvant NMDA-enhancing agents may have therapeutic benefit. DAAOI-2, a D-amino~     acid oxidase (DAAO) inhibitor, is a NMDA-enhancing agent. The aim of this project is to~     examine the effectiveness and safety of DAAOI-2 add-on treatment for treatment-resistant~     schizophrenia patients in a randomized, double-blind, placebo-controlled trial.~   "
79016|NCT02532673|"~     The purpose of this study is to determine whether HIV patients on Atazanavir who have~     Hyperbilirubinemia have different outcomes from those without Hyperbilirubinemia.~   "
79017|NCT02532660|"~     Evaluate the therapeutic effects of Escitalopram versus an association of Escitalopram +~     Trichilia catigua Dry Extract (LABCAT TCJUSS) in the average alteration on depression score~     measured by the Hamilton Scale (HAM-D).~   "
79018|NCT02532647|"~     A prospective, double-blind, randomized, placebo and active controlled, multi-center,~     parallel group study comparing remimazolam to placebo, with an additional open-label arm for~     midazolam, in ASA Grade III and IV patients (ASA status evaluated by an anesthesiologist not~     otherwise involved in the study) undergoing a colonoscopy for diagnostic or therapeutic~     reasons.~   "
79019|NCT02532634|"~     The purpose of this study is to compare the anti-emetic effect of ramosetron plus aprepitant~     and dexamethasone with palonosetron plus aprepitant and dexamethasone in patients receiving~     highly emetogenic chemotherapy.~   "
79020|NCT02532621|"~     This study is a prospective multicenter evaluation of the performance of the InterGraft~     System for anastomosis of a hemodialysis graft. The InterGraft System includes an arterial~     InterGraft (AIG) connector and a venous InterGraft (VIG) connector used with a standard~     arterial-venous (AV) graft. The study is intended to demonstrate that the 6 month cumulative~     patency of grafts connected with the InterGraft Connectors is similar to that of grafts~     connected using standard sutured anastomoses. In addition, the study will also include a~     separate cohort of up to 25 subjects in whom the VIG is used for the venous anastomosis,~     together with a standard sutured arterial anastomosis, in situations where the target artery~     is not suitable for use of the AIG.~   "
79021|NCT02532608|"~     In this study the investigators plan to systematically characterise infra-slow EEG~     oscillations during sleep, explore their relationship to the microstructure of sleep, and~     investigate its role in the physiology and pathophysiology of sleep by co-registration of~     Full band EEG with polysomnography during wake and sleep in healthy subjects, after sleep~     deprivation, and in patients with restless legs syndrome/periodic leg movements during sleep~     (RLS/PLMS).~   "
79022|NCT02532595|"~     Conflicting evidence exists regarding the recommendations from the Orthopaedic section of the~     American Physical Therapy Association for treatment of Achilles tendinitis. Trigger point dry~     needling is effective in reducing pain in several body regions, but no published (TDN)~     studies are found reporting the effect on Achilles tendinopathy. The purpose of this study is~     to investigate whether a treatment program performed including TDN, manual therapy and~     exercise will result in a significant improvement in pain, strength and function compared to~     a treatment program including manual therapy and exercise for Achilles tendinopathy. Subjects~     with Achilles tendinopathy that receive treatment including TDN, manual therapy and exercise~     will demonstrate a significant improvement in pain, strength and functional outcomes compared~     to the group that receives manual therapy and exercise.~   "
79023|NCT02532582|"~     The purpose of this study is to ultimately prevent injuries to nerves during surgical~     procedures. Living donor liver transplant or hepatectomy (removal of a piece of the liver)~     patients will receive an arterial line as standard of care. The arterial line helps monitor~     blood pressure along with the compression of important vessels during surgery. In addition,~     research participants will undergo neuromuscular monitoring using Somato-Sensory Evoked~     Potential (SSEP) or Evoked Potential Assessment Device (EPAD). During an operation,~     neuromuscular monitoring can tell doctors if the nerves being studied are working normally or~     if they are at risk for injury. This study will help investigators to understand what kind of~     monitoring is best to prevent nerve injuries during a surgical procedure.~   "
79046|NCT02532283|"~     The purpose of this study is to evaluate the Pharmacokinetic parameters of JNJ-63623872 in~     combination with oseltamivir in elderly participants (aged 65 to <= 85 years) compared to~     adults (aged 18 to <= 64 years) with influenza A infection.~   "
79026|NCT02532543|"~     This study is intended to provide statistically robust evidence that Symbios Demineralized~     Cortical-cancellous granule mix, Symbios OsteoGraf LD-300, and OsteoGraf/N-300 combined with~     Symbios OsteoShield Collagen Resorbable Membrane can adequately support the alveolus during~     ridge augmentation procedures, reducing the dimensional changes of both the alveolus and the~     overlying soft tissues. Additionally, a comparison between each material will be made,~     providing further evidence of each materials' ability to preserve the alveolus. It is~     intended to define in objective terms the response of the hard and soft tissues to ridge~     augmentation.~   "
79027|NCT02532530|"~     Delirium is an acute brain syndrome characterized by a disturbance in consciousness~     accompanied by periods of inattention and changes in cognition. Memory impairment, irrelevant~     speech and disorientation are commonly observed signs and symptoms. Episodes of delirium have~     been associated with a prolonged hospital stay, functional and cognitive dysfunction and even~     an increased mortality. Delirium is a common complication in the postoperative setting where~     the incidence increases with the risk of surgery. The estimated incidence of postoperative~     delirium after cardiovascular surgery is remarkable, ranging from 31% up to 51%. Diverse~     preoperative risk factors have been documented for patients undergoing cardiac surgery: age,~     pre-existing cognitive dysfunction, a history of alcohol abuse and the severity of illness at~     admission.~      An early diagnosis of postoperative delirium is of great importance to prevent long-term~     cognitive impairment. For this purpose, a highly specific diagnostic monitoring tool should~     be implemented during perioperative cardiac surgery care. Near infrared spectroscopy (NIRS)~     provides information on brain oxygenation by quantifying the regional cerebral oxygen~     saturation (SctO2) at the microvascular level. Recently, two studies showed that preoperative~     cerebral tissue oxygenation was lower in the cohort of patients that developed delirium~     postoperatively. Nevertheless, these studies did not investigate whether the onset of~     postoperative delirium coincided with a change of postoperative SctO2. A relationship between~     delirium and reduced cerebral blood flow has already been suggested. As such, the occurrence~     of a postoperative decrease of SctO2 might have been overlooked thus far. Hence,~     Investigators want to conduct a prospective, interventional study to determine the~     relationship between postoperative SctO2 and the onset of delirium after cardiac surgery.~   "
79028|NCT02532517|"~     The purpose of this study is to demonstrate effectiveness and safety of the CODMAN~     ENTERPRISE® Vascular Reconstruction Device and Delivery System.~   "
79029|NCT02532504|"~     The aim of this study is to deliver CBT based intervention called Change your life with 7~     Sheets of paper to women with mild to moderate postnatal depression (PND) through trained~     traditional birth attendants (TBAs). Participants will be recruited from low income area in~     Karachi Pakistan. Edinburg Postnatal Depression scale (EPDS) will be used to screen mothers~     having children between birth till 12 months. Group intervention will be delivered through~     trained TBAs.~   "
79030|NCT02532491|"~     This study compares the efficacy and effectiveness of two of the second-generation~     antipsychotics (SGAs) most used in our society in the treatment of schizophrenia~     (Aripiprazole and Risperidone) and the investigators do within an assistance program of~     early-stage psychosis individuals of the Community of Cantabria, clinical reference for the~     treatment of this disease in the Spanish Autonomous Community. Patients are included in a~     prospective naturalistic study, open flexible-doses and randomized into one of two possible~     patterns of treatment that includes the protocol.~   "
79031|NCT02532478|"~     The risk factors for stoma reversal failure have been rarely studied, which is probably one~     of the worst scenarios for a case who has a sphincter preserving procedure for a rectal~     cancer and is expecting to have regular bowel movements through a functional anus. Several~     studies have analyzed this particular issue and some have shown that up to 30% of 'temporary'~     stomas have never been closed. However these data have been criticized to be heterogeneous,~     since they have included patients with benign and malignant diseases, cases underwent~     elective or emergent anterior or low anterior resections or restorative proctocolectomy; and~     those with a colostomy or ileostomy, even an end stoma in some subjects. In addition, some~     studies have underlined some risk factors for the failure of stoma reversal, but they also~     have similar limitations as mentioned above. Finally, survival -to the best of investigators'~     knowledge- has never been separately studied in patients who cannot receive a stoma reversal~     procedure. Thus, current study aims to present a single-surgeon experience regarding the rate~     of diverting ileostomy takedown, the factors adversely affecting stoma reversal rate in~     patients underwent laparoscopic low anterior resection for rectal cancer, and accordingly to~     expose the fortune of these cases.~   "
79032|NCT02532465|"~     Endotracheal intubation is the gold standard for securing the airway. However, while managing~     patients with difficult airways, various supraglottic devices have been used as rescue airway~     devices. The aim of this study is to compare the fiberoptic view through the internal aspect~     of the i-gel versus the Air-Q LMA in pediatric patients. By examining the fiberoptic view~     through these two devices, the investigators will determine which device provides a clearer~     passage to the glottic opening and is therefore the preferred conduit to aid endotracheal~     intubation in difficult airways.~   "
79033|NCT02532452|"~     The purpose of this study is to demonstrate that viral specific T-cells (a type of white~     blood cell) can be generated from an unrelated donor and given safely to patients with viral~     infections.~   "
79034|NCT02532439|"~     Bone fracture occurrence is associated with an increasing of morbidity and mortality. Some~     factors of fracture occurrence have been highlighted. For example, some diseases or therapy~     are known to increased risk of bone fracture only in some patients. Accordingly, it is~     important for clinicians to identify patients at risk for bone fracture. Right now, various~     tools are available for the clinicians:~        -  clinical exam,~        -  bone mineral density assessed by Dual Energy X-ray Absorptiometry (DEXA),~        -  an algorithm based on interrogation, clinical exam and bone mineral density. However,~          prediction of bone fracture risk needs to be improved since only 50% of bone fractures~          can be predicted. DEXA provides information for fracture risk estimation, but it is~          unable to distinguish cortical part to trabecular part. It also fails to quantify the~          microstructural properties that influence bone strength. Bone microarchitecture,~          including the cortical compartment can now be assessed in vivo by the HR-pQCT. This~          technique allows access to several parameters: on the one hand the volumetric bone~          mineral density for the whole area measured as well as cortical and trabecular regions,~          and on the other hand, the thickness and cortical porosity and the number of trabecular,~          their orientation and distribution.~      Thus, the HR-pQCT allows realizing a virtual bone biopsy and provides information on cortical~     and trabecular bone microarchitecture. This is the only noninvasive way to assess cortical~     and trabecular bone microarchitecture.~   "
79117|NCT02531334|"~     This study is being conducted to evaluate the efficacy of TA-65, a purified extract of~     Astragalus root, on insulin resistance, oxidative stress, and inflammation in individuals~     classified with metabolic syndrome.~   "
79035|NCT02532426|"~     In addition to chronic airflow obstruction, patients with Chronic Obstructive Pulmonary~     Disease (COPD) suffer from skeletal muscle dysfunction which is a prominent and disabling~     feature and also an independent determinant of survival. Muscular impairment involves loss of~     muscle oxidative phenotype (OXPHEN: a slow-to-fast shift in fibre types and reduced oxidative~     capacity). Since hypoxia obviously is a key feature of COPD, the aim of this study is to~     elucidate the role of hypoxia in loss of muscle OXPHEN.~      Thus, OXPHEN and expression levels of its key regulators will be determined in the baseline~     biopsies for association with the degree of hypoxemia. In addition, expression levels of the~     key OXPHEN regulators will be measured in pre/post exercise biopsies.~   "
79036|NCT02532413|"~     The purpose of this study is to investigate antiviral efficacy of the combination treatment~     with Poly IC and Entecavir and compare with the efficacy of Entecavir mono-therapy for~     chronic hepatitis B.~   "
79037|NCT02532400|"~     To compare the efficacy and safety of neoadjuvant aromatase inhibitor plus ovarian~     suppression with chemotherapy in premenopausal patients with hormone receptor-positive breast~     cancer.~   "
79038|NCT02532387|"~     Standardize the approach to outpatient Pulmonary Embolism (PE) and Deep Vein Thrombosis (DVT)~     treatment.~   "
79039|NCT02532374|"~     The purpose of this study is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD,~     i.e., subjective effects) profiles, and the safety and tolerability of the~     nicotine-containing aerosol delivered by Platform 3 Liquid (P3L) system at three different~     nicotine levels in smoking healthy subjects in relation to Nicorette® inhalator.~   "
79040|NCT02532361|"~     The objective of this study is to describe the proportion of hysterectomy in patients that~     had undergone sterilization through hysteroscopic device placement and the patients that had~     undergone sterilization through tubal ligation.~   "
79041|NCT02532348|"~     HIV infection is associated with an immune activation and an inflammatory response - despite~     an active antiretroviral therapy - which may lead notably but not exclusively to~     cardiovascular diseases. It has been shown that the use of Protease Inhibitors (PI) instead~     of Non Nucleosidic Inhibitors (NNRTI) may increase the risk of myocardial infarction.~     Platelets may play a role in the occurrence of the inflammatory state: they contain big~     amounts of chemokines, growth factors, and adhesion proteins. Today, the contribution of~     platelets to the inflammatory state associated with HIV infection has been little studied.~     Thus, it has been shown that platelets in HIV patients are able to release interleukin~     (IL)-18. The group has shown with others that the platelet function could be altered during~     HIV infection. Inversely, it doesn't know how antiretroviral therapy interacts with~     platelets.~      The aim of the study is to evaluate, according to the antiretroviral therapy, the impact on~     the platelets activation markers.~   "
79042|NCT02532335|"~     OCAPUSH (EudraCT 2014-002313-33) is a double-blind placebo-controlled parallel-arms study of~     the effects of obeticholic acid on farnesoid X receptor expression in jejunum and on gut~     microbiota in morbidly obese patients and healthy volunteers. Obeticholic acid (OCA,~     6-ethyl-chenodeoxycholic acid, INT-747) is a semi-synthetic derivative of the major human~     bile acid chenodeoxycholic acid and will be administered orally at a dose of 25 mg/day during~     three weeks to 20 morbidly obese patients awaiting Roux-en-Y gastric bypass and to 20 healthy~     volunteers. On the days before the first and after the last dose faeces and blood are sampled~     for the analyses of bile acids and the gut microbiota. On the day after the last dose a~     push-enteroscopy is performed in conscious sedation for biopsy taking in the jejunum.These~     procedures are repeated 6 month after surgery in the morbid obese patients. Inclusion~     criteria are male or female gender, 20-65 years of age and morbid obesity (BMI >35 kg/m2)~     eligible for bariatric surgery. Exclusion criteria are liver diseases other that fatty liver~     disease, other significant morbidity, medications known to interact with OCA, pregnancy,~     uncertainty about safe and reliable contraception, and problems to understand or adhere to~     the protocol. The primary objectives of this pharmacodynamic trial are the study of the~     effect of OCA on the expression of FXR in the jejunum and small intestinal permeability, and~     on fecal bile acids and gut microbiota. The secondary objectives are the study of the effects~     of OCA on the genome-wide FXR DNA binding sites (cistromics) with the global gene expression~     profile (transcriptomics) in human jejunum.~   "
79043|NCT02532322|"~     Uncontrolled pain after posterior fossa surgery and associated negative side effects of~     conventional opioid therapy causes significant morbidity and mortality in infants and~     children. Intravenous (IV) acetaminophen has been shown to be effective in treating mild to~     moderate pain, and moderate to severe pain in conjunction with adjuvant opioids in children.~     However, it is unknown if IV acetaminophen is effective as analgesic adjuvant therapy in~     children undergoing posterior fossa surgery. In this prospective, randomized controlled~     trial, the investigators aim to determine whether the addition of IV acetaminophen for 24~     hours can lead to reduction in postoperative pain and opioid requirement after neurosurgical~     procedures of the posterior fossa compared with conventional therapy.~   "
79044|NCT02532309|"~     This is a 2-year, open-label, randomized study to evaluate the efficacy of Rosuvastatin~     dosing adjustment by LDL-C level compared to that of 5mg maintenance dose in chinese patients~     with Carotid Atherosclerosis.~   "
79045|NCT02532296|"~     Improving hospital-to-home care transitions can produce improvements in patient safety and~     health care outcomes, while decreasing medical costs. Most transitions research has examined~     strategies for older patients. This project, however, focuses on younger, high-risk patients~     within a safety net system. The proposed intervention is based on research that patient~     activation, as measured by the Patient Activation Measure (PAM), is correlated with risk for~     hospital readmission. The intervention seeks to increase PAM scores by employing a Transition~     Coach to coach patients, prior to and for 30-days after discharge, to (1) improve~     self-management skills through goal setting and goal attainment; (2) to enhance patient~     capacity to engage in trusting relationships with the Primary Care Provider (PCP), other~     medical specialists, family members of friends, and the Transition Coach; and (3) to improve~     ability to navigate the medical system.~      The investigators will conduct a randomized trial to determine; (a) if PAM scores can be~     increased in the 30-day after hospital discharge; (b) if increased PAM scores, in this~     setting, are correlated with changes in healthcare utilization patterns; and (c) if the~     intervention presents a viable strategy to change healthcare utilization patterns and reduce~     rehospitalizations.~   "
79047|NCT02532270|"~     The purpose of this study is to determine whether continuous non-invasive arterial pressure~     (CNAP) monitoring is beneficial to maintain maternal hemodynamic stability and improve the~     outcomes of maternal and fetal comparing with intermittent oscillometric non-invasive~     arterial pressure (NIAP)measurement during spinal anaesthesia for cesarean section .~   "
79048|NCT02532257|"~     The goal of this clinical research study is to learn if adding Imbruvica (ibrutinib) to~     Rituxan (rituximab) and Revlimid (lenalidomide) can help to control previously untreated~     follicular lymphoma (FL) and marginal zone lymphoma.~      This is an investigational study. Ibrutinib is FDA approved and commercially available for~     the treatment of patients with mantle cell lymphoma (MCL), chronic lymphocytic leukemia~     (CLL), and Waldenstrom's macroglobulinemia. Lenalidomide is FDA approved and commercially~     available for the treatment of multiple myeloma (MM), mantle cell lymphoma, and~     myelodysplastic syndrome (MDS). Rituximab is FDA approved and commercially available for the~     treatment of non-Hodgkin lymphoma (NHL).~      It is considered investigational to use ibrutinib, lenalidomide, and rituximab to treat FL~     and marginal zone lymphoma.~      Up to 60 participants will be enrolled in this study. All will take part at MD Anderson.~   "
79049|NCT02532244|"~     The goal of this study is to establish a genetic registry of patients with early-onset motor~     neuron and neuromuscular diseases. The investigators will collect samples from patients with~     a motor neuron or a neuromuscular disorder and their family members. The samples to be~     collected will be obtained using either non-invasive (saliva and buccal swabs) or minimally~     invasive (whole blood) means. The research team will then extract high quality genomic DNA~     from these samples and use it to identify and confirm novel gene mutations and to identify~     genes which regulate the severity of motor neuron/neuromuscular diseases.~   "
79050|NCT02532231|"~     The goal of this clinical research study is to learn if opdivo (nivolumab) can help to~     control AML. The safety of nivolumab will also be studied.~      This is an investigational study. Nivolumab is FDA approved and commercially available for~     the treatment of melanoma. It is considered investigational to use nivolumab to treat AML.~     The study doctor can explain how the study drug is designed to work.~      Up to 30 participants will be enrolled in this study. All will take part at MD Anderson.~   "
79051|NCT02532218|"~     The objective of this study is to evaluate the efficacy and safety of ARI-3037MO compared to~     placebo in reducing low-density lipoprotein cholesterol (LDL-C) levels in subjects with~     dyslipidemia.~   "
79052|NCT02532192|"~     The goal of this clinical research study is to find the highest tolerable dose of belinostat~     that can be combined with standard chemotherapy drugs (rituximab, cisplatin, cytarabine, and~     dexamethasone) in patients with relapsed or refractory DLBCL who are eligible for an~     autologous stem cell transplant (a transplant of the patient's own stem cells). The safety of~     the study drug will also be studied.~   "
79053|NCT02532179|"~     This is an open label trial of mouse allergenic extract administered by subcutaneous~     injection in adults with asthma and mouse sensitivity. The study is designed to evaluate:~        -  the safety of this therapy when given by injection~        -  biomarkers of the immune response and~        -  whether the therapy would be effective in treating allergic asthma.~   "
79054|NCT02532166|"~     The lichen planus is a mucocutaneous disease of unknown etiology with an incidence of 1-2%,~     that affects in 30-70% of cases either the mucosa of the mouth, or partly in combination with~     infection of the skin, the oral with his known premalignant potential in up to 2-3%~     predisposed to the development of an oral squamous cell carcinoma.In rare cases, there is~     also an manifestation of the lining of the esophagus, which can then be associated with~     symptomatic strictures of the esophagus.~      The value of moreover increasingly established endoscopic imaging procedures are investigated~     as well as data of the natural long-term outcome in esophageal lichen planus infestation~     especially in view of malignant transformation.~   "
79055|NCT02532153|"~     Every 40 seconds, someone in the world dies by suicide. There is a lack of effective and safe~     antisuicidal agents for preventing suicide attempts. This leads to the immense worldwide~     individual, financial, and societal burden of suicide—which is projected to rise in the~     coming decades—supporting the need for antisuicidal treatments.~      This treatment gap may be filled through understanding the neurobiology of suicide, which can~     guide the development of targeted antisuicidal treatments. Though some research has examined~     the neurobiology of suicidal ideation in the context of depression—implicating the orbital~     frontal cortex, anterior cingulate cortex, and striatum—the underlying pathophysiology and~     neurobiology of suicidal ideation as a separate construct from depression remains largely~     unknown. Therefore, the investigators propose to study the neurocircuitry of suicidal~     thoughts, regardless of whether or not depression is present.~   "
79056|NCT02532140|"~     • To evaluate the safety,tolerability and pharmacokinetics of single intravenous doses of WCK~     5107 alone and in combination with cefepime in healthy adult human subjects.~   "
79057|NCT02532127|"~     Cone Beam Computed Tomography (CBCT) is an emerging X-ray technology that has found wide~     applications in dentomaxillofacial imaging. The ability to provide high-resolution 3D images~     has resulted in a significant increase in the volume of dental radiology procedures. Although~     CBCT is associated with higher radiation risk to the patient than conventional dental X-ray~     imaging (intraoral or panoramic), it is considered to be 'low dose' imaging as defined by the~     High Level Expert Group (HLEG) with doses ranging from a few microsieverts (μSv) to~     millisieverts (mSv) per examination.~      This proposal is set to tackle important issues raised by the HLEG and the Multidisciplinary~     European Low Dose Initiative (MELODI) platform. In particular, as deduced by the name DIMITRA~     (Dentomaxillofacial paediatric imaging: an investigation towards low dose radiation induced~     risks), the project focuses on the uncertainties associated with radiation-induced health~     risks at low doses in paediatric dentistry and is a multidisciplinary effort to approach the~     involved risks from different yet interrelated perspectives: radiobiological~     characterisation, dosimetric quantification, epidemiological surveying and image quality &~     dose optimization. A unique Monte Carlo simulation (MC) framework will be used to accurately~     calculate organ doses in dental CBCT imaging, to quantify the radiation induced risk and to~     feed the radiobiology team with the appropriate data towards the identification, development~     and validation of biomarkers for radiation induced health effects. Furthermore, it will~     constitute the basis upon setting up a gender and age related epidemiology study. The balance~     between image quality and dose levels will be explored aiming at reducing the risk through~     image quality optimization.~      It is expected that DIMITRA`s outcomes and deliverables can be presented to a wider forum via~     a dissemination meeting, leading to further recommendations and potential future adaptations~     for the use of CBCT in paediatric dentistry.~   "
79103|NCT02531516|"~     The purpose of this study is to determine if apalutamide plus gonadotropin releasing hormone~     (GnRH) agonist in participants with high-risk, localized or locally advanced prostate cancer~     receiving primary radiation therapy results in an improvement of metastasis-free survival.~   "
79058|NCT02532114|"~     This phase I trial studies the side effects and best dose of niclosamide when given together~     with enzalutamide in treating patients with castration resistant prostate cancer that has~     spread from the primary site to other places in the body. Androgens such as testosterone can~     cause the growth of prostate cancer cells. Drugs like enzalutamide block androgens from~     driving tumor growth; however, when androgen receptor splice variants are present, these~     drugs may not be effective. Niclosamide may decrease the amount of androgen receptor splice~     variant present within tumor cells, thus promoting the anti-tumor effects of enzalutamide.~     Giving niclosamide together with enzalutamide may be a better treatment for prostate cancer.~   "
79059|NCT02532101|"~     Study reported that providing Oil Palm Phenolics to Nile rats blocked diabetes progression in~     this spontaneous diabetes model. The present study aims to determine the beneficial effects~     of Oil Palm Phenolics in uncontrolled insulin treated type 2 diabetic patients.~   "
79060|NCT02532088|"~     Study reported that providing Oil Palm Phenolics to Nile rats blocked diabetes progression in~     this spontaneous diabetes model. The present study aims to determine the beneficial effects~     of Oil Palm Phenolics in subjects with pre-diabetes.~   "
79061|NCT02532075|"~     The purpose of this study is to investigate the effects of performing a breathing muscle warm~     up before exercise in patients who have chronic obstructive pulmonary disease (COPD). The~     main aim is to see whether performing a breathing muscle warm up can improve distance walked~     in a 6 minute walk test and also decrease perceptions of effort and breathlessness.~   "
79062|NCT02532062|"~     This study aims to establish the ability of 4,000 IU oral vitamin D3 per day (in combination~     with a daily multivitamin) to safely convert vitamin D3-deficient subjects at increased risk~     of lung cancer to a vitamin D3-sufficient state, and to explore effects of vitamin D3~     supplementation in this population on markers of inflammation and lung cancer risk. Current~     and former smokers with chronic obstructive pulmonary disease (COPD) are at increased risk of~     developing lung cancer and represent the clinical population of interest for this study.~   "
79063|NCT02532049|"~     This is a clinical trial in which healthy volunteers will be administered one or two~     experimental malaria vaccines. ChAd Pfs-IMX313 will either be administered alone or with MVA~     Pfs25-IMX313 in a prime-boost regime.~      All vaccines will be administered intramuscularly.~      Group 1 will receive one dose of ChAd63 Pfs25-IMX313 at 5x10^9 vp.~      Group 2A will receive one dose of ChAd63 Pfs-IMX313 at 5x10^10 vp.~      Group 2B will receive one dose of ChAd63 Pfs-IMX313 at 5x10^10 vp and one dose of MVA~     Pfs25-IMX313 at 1x10^8 pfu eight weeks later.~      Group 2C will receive one dose of ChAd63 Pfs25-IMX313 at 5x10^10 vp and one dose of MVA~     Pfs25-IMX313 at 2x10^8 pfu eight weeks later.~      The study will assess the safety of the vaccinations, and the immune responses to the~     vaccination. Immune responses are measured by tests on blood samples.~      Healthy volunteers will be recruited in Oxford and Southampton, England.~   "
79064|NCT02532036|"~     TB040 is a clinical trial to investigate and compare the effects of a candidate Tuberculosis~     (TB) vaccine, MVA85A, administered by the aerosol inhaled route and the intramuscular route~     in healthy adult volunteers who are latently infected with Mycobacterium tuberculosis.~   "
79065|NCT02532023|"~     The aim of this study is to determine the effects of omega 3 fatty acid, curcumin and their~     combination or placebo for 2 months on the gene expression of COX-2, iNOS, TNF-α, IL-1β,~     IL-6, VCAM-1 and ICAM-1 in the peripheral blood mononuclear cell (PBMC) and serum levels of~     COX-2, iNOS, TNF-α, IL-1β, IL-6, VCAM-1, ICAM-1 and hsCRP of migraine patients.~   "
79066|NCT02532010|"~     The purpose of this study is to see if a medicine called pacritinib is both safe and~     effective as a study intervention for patients with AML in combination with either decitabine~     or cytarabine. Pacritinib is an experimental drug that is being studied to treat acute~     myeloid leukemia (AML). Decitabine and cytarabine are both FDA approved drugs that are used~     in treatment of AML. Pacritinib is being tested in clinical trials and has not been submitted~     to the U.S. Food and Drug Administration (FDA) for approval for any indications. Pacritinib~     is a drug that is designed to slow down the growth of leukemic cells.~   "
79067|NCT02531997|"~     The purpose of this study is to determine if hypnotic relaxation therapy is a more effective~     intervention for improving self-image in women who have been diagnosed with breast or~     gynecologic cancer when compared to progressive muscle relaxation therapy.~   "
79068|NCT02531984|"~     Bronchiectasis is characterized by a permanent and abnormal dilatation of a part of the~     bronchial tree. An accumulation of mucus in the respiratory tract ensues, resulting in~     frequent bacterial infections and eventual destruction of the lungs. Clinically, patients~     present with a chronic productive cough and episodes of acute respiratory exacerbations.~     Chronic respiratory failure can follow. Although its prevalence is largely unknown,~     bronchiectasis is considered to be a rare and orphan disease. There are numerous causes for~     this disease: sequelae of respiratory infections, immunodeficiency, genetic diseases like~     cystic fibrosis, primary ciliary dyskinesia….The focus of this study will be on non cystic~     fibrosis bronchiectasis in children.~      Due to a lack of pediatric clinical trials, the management of children with this disease is~     widely based on the management of adults or patients with cystic fibrosis or~     pan-bronchiolitis. The treatment is based on respiratory physiotherapy, prevention of~     infections, administration of inhaled corticosteroids and anti biotherapy for acute~     exacerbations.~      Recently, some studies have demonstrated the efficacy of a family of antibiotics, the~     macrolides, in the treatment of cystic fibrosis or pan-bronchiolitis in children. Indeed,~     taken 3 times a week during a long period of time, the macrolides, and specifically the~     azithromycin have shown some anti-inflammatory and tissue repairing properties, in addition~     to their antimicrobial properties.~      Moreover, several studies conducted in the adult population have shown that the use of~     azithromycin has led to significant reduction in the frequency of respiratory exacerbations~     as well as an improvement in the quality of life.~      The efficacy of azithromycin in these respiratory diseases has led to enlarge its use for the~     long term treatment of bronchiectasis. Yet, this type of treatment has no marketing~     authorization application.~      No studies have been conducted in children, but individual examination of patients with~     bronchiectasis treated with azithromycin suggests an improvement of their symptoms.~      Thus, the use of azithromycin in the treatment of bronchiectasis in children seems to be a~     promising therapy. However, its efficacy needs to be demonstrated by clinical trials led on a~     pediatric population with an adequate number of patients and a strong methodology in order to~     ensure validity and reliability of the results.~      Therefore the investigators decided to conduct a comparative, prospective multicenter~     randomized study in this population.~      This study intends to include 100 patients already treated by azithromycin for at least 6~     months. After inclusion, they will be randomized in two groups of 50 patients each. The first~     group will continue the treatment and the other one will discontinue it.~      The patients will be followed from the inclusion period (M0) until the onset of the first~     exacerbation for a maximum of 6 months (M6), with an intermediate health care visit after 3~     months (M3).~      In case of exacerbation, a health care visit will be scheduled; the patient will receive the~     appropriate treatment and he will be suspended from the study.~      The duration of follow up for each patient is dictated by the occurrence of the first~     respiratory exacerbation, a maximum of 6 months .The total inclusion period is 12 months and~     the total duration of the study is 18 months.~   "
79069|NCT02531971|"~     The study to be performed will utilize already FDA-approved marketed products in healthy~     adults for the purpose to generate data for establishing rate of drug delivery comparisons~     between RLD (reference listed drug) Duragesic ® TDDS (transdermal drug delivery system) and~     Generic Fentanyl TDDS in healthy adults and to ensure safety of individuals utilizing these~     types of products.~   "
79070|NCT02531958|"~     Recently, the United States Department of Agriculture (USDA) has recommended removal of the~     300mg/day limit on dietary cholesterol intake due to a lack of evidence supporting a~     connection between cholesterol intake and increased risk for cardiovascular disease (CVD).~     Previous work has shown that daily intake of eggs actually favorably alters many parameters~     associated with CVD risk. Conversely, emerging research suggests that choline, a nutrient in~     eggs, may be converted into trimethylamine oxide (TMAO) by the intestinal microbiota. TMAO is~     thought to increase the risk for CVD. Therefore, the purpose of this study is to determine a~     threshold of daily egg intake at which the risk for CVD is not negatively impacted in a~     young, healthy population.~   "
79071|NCT02531945|"~     The main objective of the study is to investigate the correlation between the measurement of~     the Cobb angle (angle of scoliosis) by conventional radiography and angle measured by surface~     topography.~      The device used in this research to the topography examination is three-dimensional~     morphometry device of AXS Medical society : the BIOMOD L.~   "
79072|NCT02531932|"~     The purpose of this study is to evaluate the safety and effectiveness of carboplatin compared~     to the combination of carboplatin and everolimus for the treatment of advanced~     triple-negative breast cancer (TNBC).~   "
79073|NCT02531919|"~     This pilot phase I trial studies the safety of long-term use of sodium bicarbonate in~     patients with cancer. Sodium bicarbonate may neutralize tumor acidity and as a result may~     inhibit the spread of the tumor to other parts of the body (metastases) and improve survival.~   "
79104|NCT02531503|"~     The purpose of this study is to determine the predicting factors for asthma remission in~     children.~   "
79074|NCT02531906|"~     This randomized pilot clinical trial studies the side effects of gabapentin and how well it~     works when given together with methadone hydrochloride and oxycodone hydrochloride in~     improving quality of life in patients with stage II-IV head and neck cancer during~     chemoradiation. Gabapentin, methadone hydrochloride, and oxycodone hydrochloride may help~     relieve moderate or severe pain caused by head and neck cancer during and after~     chemoradiation therapy.~   "
79075|NCT02531893|"~     Background:~      When children have severe irritability and temper outbursts, they can be so cranky or angry~     that it leads to problems at home, in school, and with friends. This is called Disruptive~     Mood Dysregulation Disorder (DMDD) and there have been no psychological treatments developed~     specifically for children with this problem. Researchers think two forms of therapy,~     Cognitive Behavioral Therapy (CBT) and Interpretation Bias Training (IBT), might help~     children with DMDD.~      Objective:~      To test two whether IBT and CBT can decrease severe irritability in children and youth.~      Eligibility:~      Children 8-17 years old with DMDD. Their symptoms must have started before age 10.~      Design:~      Participants will be screened with a review of their symptoms. Parents and participants will~     answer questions.~      Participants can do only one or both of these treatments if they wish. Those who wish to do~     both will start with IBT.~      Participants who do CBT will have 12-16 weekly meetings of research talk therapy. A parent~     will participate in part of the sessions.~      Participants will talk about what makes them irritable and how it affects them. They may be~     put in situations that might make them annoyed or irritable.~      Participants will rate how intense their irritability is. Parents and participants will~     complete rating scales, questionnaires, and interviews.~      Participants will do practice activities at home.~      Participants doing IBT will have up to 14 sessions over 10 weeks.~      Participants will view 15 faces, one at a time, on a computer. They will choose if the face~     looks happy or angry on a computer. Sometimes the computer gives feedback. Participants will~     complete some sessions at the NIH and some at home.~      Participants and parents answer questions about their progress.~   "
79076|NCT02531880|"~     Background:~      - The blood-brain barrier separates the brain from the rest of the body. Epilepsy is a~     neurological disease that causes seizures. It can affect this barrier. Researchers think a~     contrast agent called mangafodipir might be better able to show areas of the brain that~     epilepsy affects.~      Objective:~      - To see if mangafodipir is well tolerated and safe. To see if it can show, on an MRI, areas~     of the brain that epilepsy affects.~      Eligibility:~        -  People ages 18-60 who:~        -  Have epilepsy not controlled by drugs~        -  Are enrolled in protocol 01-N-0139~        -  Healthy volunteers~      Design:~        -  Participants will be screened with:~        -  Medical history~        -  Physical exam~        -  Blood and urine tests~        -  Participants will have up to 6 visits in 1 3 months. Those with epilepsy will have an~          inpatient stay lasting 2 10 days. Visits may include:~        -  Video-EEG monitoring for participants with epilepsy (not for healthy volunteers)~        -  An IV catheter put in place: a needle guides a thin plastic tube into an arm vein.~        -  Getting mangafodipir through the IV.~        -  5 MRI scans over a 10-day period: a magnetic field and radio waves take pictures of the~          brain. Participants lie on a table that slides into a metal cylinder. They are in the~          cylinder for 45 90 minutes, lying still for up to 10 minutes at a time. The scanner~          makes loud knocking sounds. Participants will get earplugs.~        -  A final MRI at least 2 weeks after receiving mangafodipir. Gadolinium is given through~          an IV catheter.~   "
79077|NCT02531867|"~     This is a multicenter study in Japan. Eleven sites which have already participated in the~     investigator-initiated clinical study (Early Access Program) will participate in this~     study.The objective of this study is to gain further information on the safety and efficacy~     of treatment with asfotase alfa.~   "
79078|NCT02531854|"~     -  Open label~        -  Enrollment in the order of confirmation of eligibility and HPV+ tumor status~        -  Prospective stratification based on 3 factors, epidermal growth factor receptor (EGFR)~          mutation status, performance status and first-line induction chemotherapy outcome;~        -  Randomization (2:1 ratio): (82 patients receiving the combination of pemetrexed plus~          ADXS11-001 vs. 42 patients receiving pemetrexed alone)~        -  Treatment Arm: Pemetrexed plus ADXS11-001 immunotherapy~        -  Control Arm: Pemetrexed only~        -  Positive control: pemetrexed chemotherapy~   "
79079|NCT02531841|"~     In the presently planned multicentre Phase III trial the two therapies will be compared:~     Patients will be randomized after intensified induction treatment with 4 cycles rituximab,~     methotrexate, cytarabine and thiotepa (MATRix) between first-line high-dose chemotherapy~     against conventional consolidating therapy with 2 cycles of conventional chemotherapy with~     R-DeVIC (rituximab, dexamethasone, etoposide, ifosfamide, carboplatin).~   "
79080|NCT02531828|"~     The aim of this study is validate the use of biopolymer from sugar cane molasses film~     (POLYSHAFT®) a product developed in Experimental Station research laboratories (UFRPE)~     comparing to polyurethane film, or similar, used as a bandage after surgical correction of~     hypospadias, as well as other procedures. The main objective of the study is to prove the~     hypothesis the POLYSHAFT® presents similar or better outcomes in terms of biocompatibility,~     when compared to the polyurethane film when used as a bandage.~   "
79081|NCT02531815|"~     This Phase 1 first-in-human single ascending dose study will be a randomized, double-blind,~     placebo-controlled investigation of the safety, tolerability, pharmacokinetics, and~     pharmacodynamics of PF-06741086.~   "
79082|NCT02531802|"~     The purpose of this study is to determine if the ETEC vaccine ETVAX with and without dmLT~     adjuvant is safe and immunogenic in adults, children, toddlers and infants in Bangladesh.~   "
79083|NCT02531789|"~     Current post-operative monitoring of patient recovery consists measuring two blood markers~     C-reactive protein (CRP) and White Blood Cell Count (WBC). However, these are slow to respond~     to the onset of infection. However, monitoring the absolute levels of the proteins in the~     three pathways of the complement cascade should provide a faster and better predictor of~     patient recovery. The investigators propose a pilot trial to measure concentrations of~     Complement Cascade (CC) activation biomarkers in the blood over a time course around~     operations of major abdomino-pelvic surgery involving a bowel resection. Further, analysis of~     the differential CC pathway activation should identify the onset of recovery complications~     before clinical symptoms present and potentially identify the causes allowing the clinicians~     to target therapies.~   "
79084|NCT02531776|"~     This study will focus on how different injection needles are perceived by patients. The~     needles differ in design and mechanical properties, and will be tested in people with Type 2~     Diabetes. The measured parameters during and after needle insertion are: penetration force~     through skin (measured with force gauge), pain perception (rated on visual analog scale, VAS,~     on a scale from 0 to 10), and skin blood perfusion at insertion site (measured with laser~     speckle contrast scanner). Furthermore, any skin reactions will be recorded.~   "
79085|NCT02531763|"~     BE FIT (Behavioral Economics Framingham Incentive Trial) is a pilot study to test the~     deployment of a social incentive intervention using the Framingham Heart Study (FHS)~     Offspring, Generation 3, and Omni cohorts to increase physical activity (PA). The~     investigators will leverage the strength of FHS by recruiting trios and nuclear families to~     test whether social connectedness increases PA. The investigators will utilize a randomized~     controlled trial design. The investigators will test a social incentive intervention strategy~     using a team-based design in which participants work together to jointly achieve their PA~     goals, and a social connectedness intervention.~   "
79086|NCT02531750|"~     Introduction This study will evaluate the effect on glucose, lipid and bone metabolism~     following conservative orthopaedic procedures in patients who suffered from acute Achilles~     tendon rupture. The sedentary rehabilitation period following these procedures may impact~     negatively upon glucose, lipid and bone metabolic pathways whereas the more physically active~     rehabilitation period instituted 8 weeks after the injury is hypothesized to impose positive~     metabolic effects.~      The study is addition to the on-going clinical trial, Non-operative Treatment of Acute~     Achilles Tendon Rupture: Early Controlled Mobilization Compared With Immobilization,~     ClinicalTrials.gov Identifier: NCT02015364.~      Perspective This study will establish whether the well-known effects on glucose, lipid and~     bone metabolism of a sedentary lifestyle can be observed already following 8 weeks of almost~     total abstain from physical activity in non-diabetic individuals, who suffered an acute~     Achilles tendon rupture. Thereby, we will add knowledge to the previous findings following~     strict bed-rest in healthy individuals on glucose and lipid metabolism and bone turnover. In~     a clinical perspective it is important to examine the extent to which individuals deteriorate~     in various metabolic pathways to better understand the pathophysiology behind these defects~     both in healthy individuals and in patients, who undergo bed rest or an equal reduction in~     physical activity as part of their rehabilitation.~      Study design The present study includes 50 cases, who are examined early following injury (<~     2 weeks) (baseline), 8 weeks (6 - 10 weeks) after injury and 52 weeks (40 - 64 weeks) after~     injury, respectively.~      Oral glucose tolerance test (OGTT) with ingestion of 75 g of glucose during a maximum of 3~     min from baseline (0 min). Plasma for glucose, insulin, C-peptide, NEFA will be drawn.~      The individual will bring in morning spot urine for measurement of suPAR, creatinine, albumin~     and orosomucoid.~      The individual will have drawn blood for measurement of HbA1c, total cholesterol, LDL~     cholesterol, HDL cholesterol, triglyceride, Na, K, creatinine, HgB, CRP, leukocytes, ALAT,~     alkaline phosphatase, Ca++, D vitamin, TSH, albumine and amylase. Also blood for BTM and~     plasma suPAR, IL6, TNFa and hsCRP will be drawn. Finally blood for lipid density profiling~     and lipid particle size will be drawn DXA of hip and lumbar spine including abdominal~     visceral and subcutaneous fat is done on a Hologic Discovery scanner.~   "
79087|NCT02531737|"~     The purpose of this study is to determine whether nintedanib (vargatef®) combined with~     docetaxel are effective in second line of treatment in patients with no squamous non small~     cell lung cancer refractory to first line chemotherapy.~   "
79088|NCT02531724|"~     Acute kidney injury (AKI) is a common complication after cardiac surgery. Mismatch in renal~     oxygen demand-supply may be an important pathogenetic factor. Levosimendan has been shown to~     improve renal blood flow, glomerular filtration rate and renal oxygenation in healthy~     controls after cardiac surgery.~      In order to investigate the effect of levosimendan in patients with AKI after cardiac~     surgery, the investigators plan a randomized placebo controlled trial. 30 patients will~     receive levosimendan or placebo. Renal blood flow and filtration fraction will be measured~     using infusion clearance technique of para-aminohippuric acid and Chromium~     ethylenediaminetetraacetic acid (Cr-EDTA) respectively.~   "
79089|NCT02531711|"~     The goal of this proposed research is to assess the preliminary efficacy of dietary~     interventions that change dietary fats in improving clinical outcomes related to lumbar~     radicular pain. After a two-week baseline, consented participants are randomized to one of~     two diets. Key foods consistent with the diet are provided for 12 weeks along with extensive~     dietary counseling and support from the study-provided materials. Participants are encouraged~     to follow the assigned diet for another 6 weeks without provision of food.~      Participants complete questionnaires at baseline, randomization, and after 6 weeks, 12 weeks,~     and 18 weeks on the diet. They provide blood samples at randomization (2 weeks) and after 12~     and 18 weeks on the diet.~   "
79090|NCT02531698|"~     This study is looking at a new vaccine that might prevent meningococcal disease, and will~     study the immune response elicited by this vaccine when given to healthy young children. The~     study will also look at the safety of the new vaccine as well as how it is tolerated.~   "
79091|NCT02531685|"~     Many infectious pathogens, like ETEC, initiate infection by first interacting with the gut~     mucosal surfaces of their human host. Consequently, vaccination strategies that can better~     stimulate protective mucosal immunity are needed if we are to effectively control the large~     number of intestinal pathogens that cause morbidity and mortality in humans. The LT toxin of~     ETEC is a unique antigen in that it also has inherent mucosal adjuvant properties for~     co-administered antigens. Thus, this protein has the potential to be both a stand-alone~     vaccine as well as a mucosal adjuvant for other co-administered vaccine antigens. The primary~     objective is to assess the safety and tolerability of dmLT vaccine when administered in three~     doses intradermally over a range of dosages in healthy adult subjects.~   "
79092|NCT02531672|"~     The purpose of this study is to use a new imaging drug called 11C-choline that is used with a~     PET/CT scan to see prostate cancer when it cannot be seen well on other scans, such as bone~     scans, CT or MRI.~   "
79093|NCT02531646|"~     The purpose of this study is to evaluate the imaging performance of Dual Energy and Digital~     Tomosynthesis (DE-DT) application against the commercially available predicate devices.~   "
79113|NCT02531386|"~     The objective of this study is the evaluation of system accuracy following ISO 15197:2013~     (E), clause 6.3 in which accuracy requirements and applicable test procedures for blood~     glucose monitoring systems intended for self-monitoring of blood glucose by patients are~     stipulated. In this study, system accuracy evaluation will be performed with CE-marked BGMS~     (BGMS = Blood Glucose Monitoring System) common among insulin pump users - Accu-Chek Aviva~     Nano and Accu-Chek Performa Nano (Roche Diagnostics), FreeStyle Lite (Abbott Diabetes Care),~     OneTouch Verio IQ (LifeScan) Contour Next Link 2.4 (Bayer Healthcare Diabetes Care) and~     Accu-Chek Mobile with three different reagent system lots for each BGMS.~      The study will be performed in 2 parts. Each part will comprise testing of 3 BGMS.~   "
79114|NCT02531373|"~     This study is designed to assess the effect of different dose levels of pneumococcal~     polysaccharide and adjuvant on the safety and immunogenicity of V114 in healthy adults and~     infants.~   "
79094|NCT02531633|"~     Sirukumab is a fully human anti-interleukin-6 (IL-6) immunoglobulin G1-kappa with a high~     affinity and specificity for binding to the human IL-6 molecule that may have therapeutic~     benefit in the treatment of giant cell arteritis (GCA) by interruption of multiple pathogenic~     pathways. Sirukumab inhibits IL-6-mediated signal transducer and activator of transcription 3~     (STAT3) phosphorylation, resulting in the inhibition of the biological effect of IL-6. This~     study will evaluate the efficacy and safety of sirukumab to characterize the benefit-to-risk~     profile of sirukumab in the treatment of active GCA. The study will be conducted in 2~     distinct parts (Part A and Part B) and consists of the following phases: Screening phase,~     Part A: 52-week double-blind treatment phase, Part B: 104-week extension phase with the~     option to receive open-label sirukumab based on disease status and a 16-week follow-up phase~     if applicable.~      Approximately 204 subjects with a diagnosis of GCA and active disease within 6 weeks of~     baseline will be randomized into Part A, the 52-week double-blind treatment phase, to receive~     one of two doses of sirukumab or placebo, each in addition to a pre-specified prednisone~     taper. The efficacy and safety of sirukumab in sustaining remission will be assessed at Week~     52. Subjects completing Part A of the study will be eligible to enter Part B, the 104-week~     extension phase, designed to investigate the long-term maintenance of remission and safety~     following cessation of sirukumab treatment and to assess long-term corticosteroid use.~     Subjects with active GCA at the end of Part A or those with new onset of GCA flare during the~     first 52 weeks of Part B will be eligible to receive open-label sirukumab. Subjects will need~     to have follow-up safety evaluations for at least 16 weeks after receiving the last dose of~     study drug, applicable only for those who are withdrawn prematurely from the study or whose~     open-label sirukumab treatment in Part B completes after Week 88.~   "
79095|NCT02531620|"~     This is a pilot study designed to evaluate a programme of rehabilitation for patients~     undergoing elective colorectal resection surgery.~   "
79096|NCT02531607|"~     This is a non-randomized natural history protocol in which patients undergoing surgery or~     endoscopy for suspected/ diagnosed pancreaticobiliary strictures are assigned to a) control~     (chronic pancreatitis, no pancreatic neoplasm, primary sclerosing cholangitis), b)~     non-carcinoma (bile duct stones, papillary stenosis, ), c) carcinoma non-pancreatic~     (ampullary and distal bile duct or cholangiocarcinoma) and d) pancreatic ductal~     adenocarcinoma (pancreatic cancer.~   "
79097|NCT02531594|"~     This study will test the efficacy of a cessation intervention for caregivers in a large,~     inner-city Pediatric Emergency Department. The investigators will randomize 750 caregivers~     who smoke who present to our Pediatric Emergency Department with their child who has a Second~     Hand Smoke exposure-related illness to either one of two conditions: 1) Screening, Brief~     Intervention, and Assisted Referral to Treatment (SBIRT); or 2) Healthy Habits Control (HHC).~     The Screening, Brief Intervention, and Assisted Referral to Treatment condition will include~     a brief form of the Clinical Practice Guideline: Treating Tobacco Use and Dependence,~     motivational interviewing, engaging and personalized materials on the effects of smoking and~     Second Hand Smoke exposure, immediate access to caregivers' choice of cessation resources~     (e.g., Quitline, smokefree.gov, or txt2quit), a 12-week supply of nicotine replacement~     therapy and weekly booster materials for 12 weeks. The Healthy Habits Control program will be~     used as an attention control in which caregivers will receive instruction on healthy~     lifestyle choices to improve the child's health.~   "
79098|NCT02531581|"~     Pulmonary embolism (PE) is a serious disease with frequent intra hospital mortality remains~     high. If anticoagulation is perfectly codified, the remainder of the initial management has~     been less studied.~      In particular, the conditioning Initial often involves systematic plasma volume of 250 to~     500 cc, by analogy to other situations. But this treatment option is not based on factual~     data. In the right ventricular dysfunction that often accompany severe EP, volume expansion~     may instead be harmful, according to the law of Frank Starling. A retrospective study has~     recently shown a benefit of diuretic therapy in patients hospitalized for severe normotensive~     EP.~      The proposed study is interventional, prospective, multicenter, randomized, require to~     include 60 patients.~      The main objective of the study is the comparison of the troponin normalization period Ic~     (biomarker of right ventricular dysfunction) in patients hospitalized in the initial phase of~     a serious normotensive EP, between the 2 groups diuretic and filling Vascular.~      The primary endpoint is the time in hours standardization of troponin Ic.~      The secondary endpoints will be:~        -  the period of normalization of Brain Natriuretic Peptide (BNP)~        -  changes in echocardiographic parameters of right ventricular dysfunction~        -  a composite endpoint: cardiovascular death / cardiogenic shock / use of amines / use of~          thrombolysis.~   "
79099|NCT02531568|"~     The purpose of this study is to evaluate the effects of MT-3995 on the PK of warfarin~   "
79100|NCT02531555|"~     Background: Aim of this randomized controlled parallel-designed study was to evaluate the~     effects of diode laser as an adjunct to mechanical periodontal treatment on clinical~     parameters and gingival crevicular fluid (GCF) volume of the residual pockets diagnosed~     following initial periodontal treatment in chronic periodontitis (CP) patients.~      Methods: A total of 84 residual pockets on single-rooted teeth in 11 CP patients were~     included and randomly assigned into 3 groups. Residual pockets were treated either only by~     mechanical treatment (Group M) (n=28), only by diode laser disinfection (Group L) (n=28) or~     by combination of these techniques (Group M+L) (n=28). Plaque index, gingival index (GI),~     bleeding on probing (BoP), probing depth (PD), clinical attachment level and gingival~     recession were assessed at baseline and 8 weeks after treatment of residual pockets. GCF~     samples were collected at baseline, 1 and 8 weeks after treatment.~   "
79101|NCT02531542|"~     Elderly people constitute the largest proportion of emergency room patients, representing 12%~     of all emergency room admissions. The need for diagnostic tests or therapeutic interventions~     is much greater in this patient population. Cardiovascular diseases and symptoms represent~     12% of the causes for emergency room admission, and patients suffering from cardiovascular~     disease are those whose emergency room visit lasts longest.~      The diagnostic approach in the emergency room in elderly patients admitted for acute dypsnoea~     is complex, and early identification of acute left-sided heart failure (ALSHF) is vital as it~     has an impact on prognosis. The clinical signs are difficult to interpret, and are~     non-specific, particularly at the acute phase and in elderly or obese patients. Indeed, some~     authors have reported up to 50% of diagnostic errors in elderly patients.~      Measure of the blood concentration of a natriuretic peptide allows a quick diagnosis.~     However, peptides suffer from several limitations, particularly in situations that are often~     encountered in elderly patients, such as sepsis, renal failure, acute coronary syndrome,~     pulmonary embolism, chronic respiratory failure, atrial fibrillation and high body mass~     index. Diagnostic performance deteriorates with increasing age, and there is a significant~     increase in this grey-zone in patients aged ≥75 years. In critical situations in elderly~     patients, assessment of natriuretic peptides serve mainly to rule out a diagnosis of left~     heart failure.~      Some authors have suggested using lung ultrasound in the initial work-up of acute respiratory~     failure, since some specific profiles are known to be related to the presence of interstitial~     oedema, reflecting impaired left heart function (e.g. presence of B lines). These studies~     were performed in the context of intensive or critical care, but data are sparse regarding~     the application of this approach in the emergency room.~      The hypothesis is that the diagnostic accuracy of a targeted and quick echographic approach,~     namely the READ method (Rapid Echography for Acute Dyspnoea), comprising targeted lung~     ultrasound combined with isolated measure of transmitral flow, would be superior to that of~     NT-proBNP assessment for the diagnosis of ALSHF in elderly patients (≥75 years) admitted to~     the emergency department.~   "
79102|NCT02531529|"~     To compare between the analgesic effect of dexmedetomedine infusion versus Fentanyl infusion~     during donor hepatectomy.~   "
79105|NCT02531490|"~     Paradoxical fetal and maternal results of studies have led to inconsistent use of~     antihypertensive drugs or no treatment at all in mild to moderate gestational hypertension in~     the Netherlands. However, none of the studies have taken the individual maternal circulatory~     state or the contemplated blood pressure response into account. Hypertension may be~     accompanied by high (hyperdynamic vasodilated profile), normal (normodynamic profile) of low~     (hypodynamic vasoconstrictive profile) cardiac output, and preeclampsia is not restricted to~     one circulatory profile. Therefore antihypertensive drugs should be viewed upon as correctors~     of the hemodynamic state rather than solely reducers of blood pressure. Without taking the~     maternal hemodynamic profile and condition into account, generic antihypertensive treatment~     can be expected to result in disappointing, inadequate and paradoxical results. The~     investigators hypothesize that in mild to moderate hypertension, personalized hemodynamically~     guided antihypertensive therapy (with target systolic and diastolic blood pressure~     <130/80mmHg), prevents the progression to severe hypertension and/or preeclampsia compared to~     no treatment, without the alleged side-effects.~   "
79106|NCT02531477|"~     Intra-Carotid delivery of propofol.~   "
79107|NCT02531464|"~     Family caregivers play a crucial role in cancer patients care, as they are their principal~     source of support. It is well recommended to provide them with the resources, information and~     support needed to maintain a good health, and to sustain their caregiving role. Recently,~     oncology centres have implemented systematic distress screening programs, but the focus has~     been limited to cancer patients, with little intervention on family caregivers. This study~     aims to address this gap. It will implement and test the effectiveness of a simple~     intervention integrating primary care and oncology care that transfers into practice the main~     recommendations of governmental authorities and experts to globally improve supportive care.~     The intervention includes systematic distress screening and problems assessment of family~     caregivers at diagnosis, and every two months, privileged contact with a nurse away from the~     patient to address caregivers distress and identified problems, and for caregivers~     experiencing high level of distress, liaison by the study nurse with their family physician~     to transfer information on their identified problems and level of distress and to facilitate~     shared follow-up. This intervention has been pilot-tested with family caregivers, health care~     providers and decision makers involved in lung cancer care, as well as with community-based~     family physicians, to ensure its feasibility and acceptability. This study findings may~     clearly improve patient and caregiver experience of cancer care, and reduce the burden of~     disease.~   "
79108|NCT02531451|"~     In this study, healthy human subjects (18-35 yrs) are be randomised to consume 1200 mg~     ibuprofen or 75 mg acetylsalicylic acid daily during a training period of 8 weeks. During~     these weeks, subjects perform 2-3 supervised strength training sessions (knee extensions).~     Before and after training, muscle volume is measured by MRI, and muscle strength is assessed~     by isokinetic and isoinertial ergometers. Muscle biopsies are obtained from m. vastus~     lateralis to study gene and protein expression of markers regulating muscle protein turnover~     and prostaglandin synthesis.~   "
79109|NCT02531438|"~     The purpose of this study is to evaluate the safety and efficacy of omadacycline as compared~     to moxifloxacin in the treatment of adults with community-acquired bacterial pneumonia.~   "
79110|NCT02531425|"~     Intratumoral plasmid IL-12 electroporation (IT-pIL12-EP) will be administered to~     approximately 10 patients with triple negative breast cancer (TNBC) with cutaneous or~     subcutaneous disease. Patients will receive one complete cycle of therapy, consisting of~     local injection of plasmid IL-12 (pIL-12) followed immediately by electroporation (EP), into~     accessible tumor lesions. IT-pIL12-EP will be administered in Days 1, 5, and 8 of the single~     28-day cycle.~   "
79111|NCT02531412|"~     Acute kidney injury frequently affects cancer patients. The main cause of acute kidney injury~     is ischemic damage caused by transient decrease in renal blood flow, followed by blood flow~     restoration and accompanying reperfusion injury (ischemia-reperfusion injury. Several~     studies, mainly in animal models have tried to establish spironolactone role on kidney injury~     induced by ischemia-reperfusion injury. It has been demonstrated in renal transplant~     recipients that the administration of spironolactone can prevent oxidative stress and is~     safe. The group of cancer patients with states capable of producing tissue hypoperfusion~     (hypovolemic shock, heart failure, major surgery, use of anesthetics) are at increased risk~     of developing acute renal ischemia-reperfusion injury.~      The investigators hypothesis is that spironolactone may be useful in preventing acute renal~     injury when administered during the first six hour of renal ischemia-reperfusion insult.~      The purpose of this study is to determine the utility of spironolactone administered after an~     ischemic renal insult (major surgery) to prevent acute kidney injury in critically cancer~     patients.~      Investigators propose a pilot study, randomized, double blind, placebo controlled trial,~     approved by the local ethical committee, to compare the efficacy of spironolactone to prevent~     acute kidney injury in patients after major surgery. Investigators will include 12 patients~     in spironolactone group (25mg daily for three days) and 12 patients in placebo group.~   "
79112|NCT02531399|"~     Neurovascular coupling or functional hyperemia is defined as an essential physiologic~     mechanism in the brain, which is necessary for the local adaption of blood flow to altered~     metabolic demands of the tissue. It has been shown that also in the eye, blood flow is~     considerably coupled to retinal neural activity. The current concept of functional hyperemia~     is that visual stimulation, as flicker light, effectuates increasing neural activity in the~     retina, which elevates the metabolic needs of the retinal tissue for oxygen and glucose and~     consequently induces dilatation and augmented blood flow in the retinal vasculature. In~     several studies, stimulation with flicker light has been shown to induce an increase of blood~     flow in major retinal arteries and veins as well as an increase of optic nerve head blood~     flow. Up until now, flicker induced changes in blood flow were measured solely in the major~     retinal arteries and veins with systems such as the commercially available dynamic vessel~     analyzer (DVA) by Imedos and with laser Doppler velocimetry (LDV).~      In the present study, the investigators propose to measure the response of total retinal~     blood flow to diffuse luminance flicker stimulation with bi-directional Fourier Domain~     Doppler Optical Coherence Tomography (FDOCT) as well as with Laser Speckle Flowgraphy (LSFG)~     in healthy subjects by assessing vessel diameter, blood velocity and blood flow of all~     retinal vessels. For comparative reasons, the investigators will furthermore assess the blood~     flow of major retinal arteries and veins with the dynamic vessel analyzer (DVA) and laser~     Doppler velocimetry (LDV).~   "
79118|NCT02531321|"~     The project is a two-arm prospective cohort and pharmacokinetic study comparing~     levonorgestrel and ethinyl estradiol pharmacokinetics in HIV-positive women taking~     antiretroviral regimens that include ritonavir to those in women who take regimens known not~     to interact with combined oral contraceptives. In addition, the prevalence of ovulation will~     be measured in each group. Participants will take a combined oral contraceptive containing~     levonorgestrel and ethinyl estradiol for 21 days, during which they will undergo twice-weekly~     serum progesterones. On the final day, they will complete a pharmacokinetic study. The~     investigators hypothesize that levonorgestrel levels, as measured by area-under-the-curve~     from 0 to 72 hours, will be increased in women on ritonavir, while ethinyl estradiol levels~     will be decreased and ovulation, defined by a serum progesterone of at least 3 ng/mL, will be~     unchanged.~      This study will be the first to evaluate the effects of ritonavir on the pharmacokinetics of~     a combined oral contraceptive containing the progestin levonorgestrel. In addition, no~     previous studies have rigorously assessed ovulation in women taking protease inhibitors and~     combined oral contraceptives. As a result, this study will provide new information~     correlating pharmacokinetic changes with effects on ovulation.~   "
79119|NCT02531308|"~     Evaluation of impact of metformin on 2 year progression-free survival (PFS) rate in subjects~     with previously untreated DLBCL when added to standard induction therapy. (R-CHOP)~   "
79120|NCT02531295|"~     The purpose of this study is to determine the safety and bioactivity of an herbal supplement~     called kansui, which contains several active ingredients such as ingenols that may have a~     role in helping clear HIV from the body. Kansui has been used in traditional Chinese medicine~     for centuries to treat various ailments such as for eliminating excess fluid in the abdomen~     or lungs, loosening phlegm from the chest, and relieving constipation. Based on preliminary~     in vitro data from our group, kansui extract powder is a potent activator of HIV~     transpcription in latently infected Jurkat cells. The investigators' hypothesis is that~     kansui extract powder prepared as tea will be safe and well-tolerated, elicit an in vivo~     immunologic response, and at the doses administered, increase HIV transcription in~     latently-infected cells among HIV-infected patients on suppressive antiretroviral therapy.~   "
79121|NCT02531282|"~     The study's primary objective is to test the hypothesis that a group-based health promotion~     intervention with patient education and practical exercises delivered at a Healthy Life~     Centre increases patient activation in people living with chronic pain. Due to many people~     living with chronic pain, interventions focusing on self-management and coping are on the~     agenda in primary care. This study will investigate whether a Healthy Life Centre in a~     municipality is a suitable setting for interventions targeting people living with chronic~     pain. Short and long term effect of an intervention developed in a health promotion and~     salutogenic framework will be investigated in a randomized clinical trial.~   "
79122|NCT02531269|"~     Using European data from patients included in the Named Patient Program (NPP) and from the~     early post-marketing authorization period, the present study aims to describe patient~     characteristics and to describe the effectiveness of Daclatasvir (DCV)-based regimens in~     Europe. This will be a retrospective cohort study of patients who received treatment with a~     DCV-based regimen in the following context:~        -  Patients enrolled within the European NPP in one of the following countries Austria,~          Denmark, Italy, Sweden, Spain, Switzerland, United Kingdom; or~        -  In those countries where DCV is commercially available (ie, Sweden, Germany, United~          Kingdom), patients who received DCV during the early post-marketing authorization period~      The results of this study will contribute to a better understanding of effectiveness of~     DCV-based regimens in a population that differs from population in the clinical trials, and~     therefore will provide additional valuable information to inform clinical practice.~      This study intends to estimate primarily the effectiveness of DCV-based regimens as measured~     by the sustained virologic response at post treatment follow-up visit week 12 (SVR12). As~     well as estimate the effectiveness of DCV-based regimens as measured by SVR12 after the end~     of Hepatitis C virus (HCV).~      This study intends also to describe as secondary objectives the characteristics (ie,~     demographic and clinical characteristics and treatment patterns of patients starting a new~     DCV-based regimens) of patients receiving DCV as well as the effectiveness of DCV-based~     regimens as measured by:~        -  On-treatment virological response at post treatment follow-up visit Week 4; and~        -  Virological response at the end of treatment (EOT); and~        -  The sustained viral response at post treatment follow-up visit Week 4 (SVR4) and post~          treatment follow-up visit Week 24 (SVR24); and~        -  The occurrence of virological failure (on-treatment and relapse).~      An exploratory objective will be to assess the concordance between SVR4 and SVR12 among the~     overall population treated with DCV.~   "
79123|NCT02531256|"~     Evaluation of LMA Protector~   "
79124|NCT02531243|"~     The purpose of this study is to learn whether a new family therapy using computer games with~     biofeedback might help people at clinical high risk for psychosis and their family members~     learn to experience less stress and have fewer mental health challenges.~   "
79125|NCT02531230|"~     The aim of the study is to assess the safety and efficacy of the Multi-LOC® peripheral stent~     system to treat de novo and restenotic lesions (no in-stent restenosis (ISR), no restenosis~     post drug coated balloon (DCB) after flow limiting plain old balloon angioplasty (POBA)~     and/or DCB dilatations in the superficial femoral artery (SFA) and popliteal segments (P1, P2~     & P3)~   "
79126|NCT02531217|"~     The purpose of this study is to assess the safety and tolerability profile of ATYR1940 in the~     treatment of adult patients with molecularly defined genetic muscular dystrophies.~   "
79127|NCT02531204|"~     The purpose of this study is to assess the bioequivalence between ASP1585 granules and~     ASP1585 capsules after repeated oral administration of ASP1585 granules or ASP1585 capsules~     under open-label conditions in non-elderly healthy male subjects. In addition, the safety of~     these products is assessed.~   "
79128|NCT02531191|"~     The objective of this study is to evaluate the bioequivalence of a new tablet versus a~     current tablet of ASP015K under fasting conditions after single oral administration in~     healthy male subjects.~   "
79129|NCT02531178|"~     This is a Phase 1, randomized, double-blind, placebo-controlled, multiple dose study designed~     to assess the safety, tolerability, pharmacokinetics, and immunogenicity of different dose~     levels of ABBV-257 given with methotrexate. ABBV-257 or placebo will be administered once~     every other week (EOW) for a total of 4 doses. Subjects will continue on their stable dose of~     methotrexate weekly throughout participation in the study.~      This study will be conducted in approximately 24 subjects in 3 dose groups, with 8 subjects~     per group. Within each group, 6 subjects will be randomized to receive ABBV-257 and 2~     subjects will receive placebo. Subjects participating in one dose group will be ineligible to~     participate in another dose group in the study.~   "
79130|NCT02531165|"~     Prospective, randomized, open-label, single-center, investigator-initiated trial, including~     patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary~     percutaneous coronary intervention (PPCI) within 12 hours of the symptom's onset. The study~     aims to compare platelet inhibition (pharmacodynamics and pharmacokinetics) of pre-hospital~     Ticagrelor in patients with STEMI according to two different analgesia protocols using~     Fentanyl or Morphine.~   "
79131|NCT02531152|"~     Primary Objective:~      To assess the local and systemic safety and tolerability of ascending repeated topical doses~     of SAR366234 monotherapy in patients with open angle glaucoma (OAG) or ocular hypertension~     (OHT) as compared to latanoprost.~      Secondary Objective:~      To assess the pharmacodynamic activity of ascending repeated topical doses of SAR366234 in~     patients with OAG or OHT as compared to latanoprost.~   "
79132|NCT02531139|"~     Anesthesia reduces blood pressure and cerebral blood flow is normally considered to be~     maintained despite marked changes in blood pressure. Vascular surgical patients are often~     elderly, have high blood pressure and atherosclerosis and in these patients cerebral blood~     flow may decrease if blood pressure is reduced during anesthesia. The purpose of this study~     is to assess the effect of blood pressure for preservation of cerebral blood flow during~     anesthesia in vascular surgery. The hypothesis is that in vascular surgical patients, during~     anesthesia, cerebral blood flow is higher with blood pressure maintained at a higher level~     than that used in normal clinical practice.~   "
79133|NCT02531126|"~     The purpose of the trial is to determine the safety and efficacy of RPC1063 in patients~     diagnosed with moderate to severe ulcerative colitis.~   "
79134|NCT02531113|"~     The purpose is to determine whether RPC1063 is effective in the treatment of Crohn's disease.~   "
79135|NCT02531100|"~     This study is designed to assess the safety and effectiveness of BonyPid-500TM implantation~     for intrabony peri-implantitis defects.~      BonyPid-500™ is a bone graft substitute, which contains an antibiotic drug - doxycycline, and~     is intended for filling and reconstruction of bone defects caused by peri-implantitis.~   "
79136|NCT02531087|"~     Osteogenesis imperfecta (OI) is a rare inherited disorder that causes bones to break easily.~     Individuals with osteogenesis imperfecta break bones often and may have other problems,~     including hearing loss, dental problems, pain and difficulty getting around. Before the~     genetic cause of OI was known, OI was classified into four types. Each type was based upon~     the symptoms and severity of OI. In most people with OI, the cause is a change in one of the~     genes that makes a protein called type 1 collagen. Some doctors now classify OI both on how~     severe it is as well as which gene is causing OI. When people classify OI this way, there are~     more than 10 types of OI. The current laboratory testing to determine OI subtype involves the~     collection of blood and/or skin cells.~   "
79137|NCT02531074|"~     This pilot study evaluates the use of a mobile application to improve weight loss in obese~     stroke patients. The investigators hypothesize that acute stroke patients who use the mobile~     application are more likely to achieve a minimum 5% weight reduction during the critical six~     months post-stroke, yielding considerable improvement in stroke risk factors.~   "
79138|NCT02531061|"~     Since biological disease-modifying anti-rheumatic drugs (bDMARDs) are available in rheumatoid~     arthritis (RA) strategy an emerging question is the definition of remission in RA. Today some~     criteria were already proposed and the last one was proposed in 2011.~      All these criteria integrated only clinical criteria without imaging assessment. In this~     context, ultrasound joint is daily performed without definition of remission. A discrepancy~     exists between clinical remission and persistence of active disease with ultrasound joint~     presence of a Doppler effect indicating inflammation and the risk of progression of joint~     damage. A definition of remission in RA could include erosions regression in subchondral bone~     (at best measured by high resolution peripheral quantitative computed tomography (HR-pQCT)).~      The main hypothesis is that the reduction of erosion size assessed by HR-pQCT will be~     observed only in the absence of local inflammation measured by Doppler ultrasound in the~     erosion.~      Tumor Necrosis Factor (TNF) blockers have strongly improved RA therapy outcome in terms of~     clinical improvement and structural damage (progression of radiographic lesions). Recent data~     showed that there could be joint bone rebuilt in case of inflammation suppression. HR-pQCT is~     a new technique emerging for bone erosions assessment in RA. Erosions size and volume could~     be reduced with anti-TNF, but with a large interindividual variability. There was no~     correlation between the activity of clinical or ultrasound synovium and evolution of erosion~     HR-pQCT.~   "
79139|NCT02531048|"~     Different neurological damage may alter the pain conduction systems centrally (spinothalamic~     pathway) or peripherally (small caliber sensory fibers A delta and C). The laser thermal~     stimulation selectively stimulates the pain pathways and generates nociceptive signals~     conveyed to the cortex. Registering these cortical responses constitute the technical laser~     nociceptive evoked potentials. If these tests are routinely used, their interpretation must~     remain cautious especially in the elderly.~   "
79140|NCT02531035|"~     This Phase 3 study is designed to demonstrate the net benefit of sotagliflozin versus placebo~     in patients with T1D.~   "
79141|NCT02531022|"~     This study will use a randomized, controlled trial to test the effectiveness of a home-based~     physical activity program using wearable devices and financial incentives. All participants~     in will establish a baseline step count during the first two weeks and then proceed to a~     16-week intervention period and 8-week follow-up period.~   "
79142|NCT02531009|"~     The primary objective of the study is to assess the change in systemic sclerosis~     (SSc)-associated gastrointestinal (GI) tract symptoms over a 1-year period in participants~     with SSc.~   "
79143|NCT02530996|"~     Systemic sclerosis (SSc; scleroderma) is a multi-organ systemic disease characterized by~     activation of immune cells, which results in vascular dysfunction (vasculopathy) and~     subsequent scarring (fibrosis). SSc has a higher than expect prevalence in the US military.~     On a national level there are 5,766 SSc patients (ICD-9 710.1) presently cared for in the~     Veterans Health Administration (VHA). While there is no cure for SSc, studies of therapeutics~     that can help slow disease progression are valuable to our Veterans. This proposal addresses~     the solicitation for projects with attention to SSc requested by President Obama after~     reviewing potential contamination of water at Camp Lejeune. This proposal is a~     patient-centered outreach for our Veterans with SSc to inform and prevent catastrophic~     endstage vascular abnormalities, including digital ulcers, pulmonary arterial hypertension~     (PAH) and scleroderma renal crisis in SSc. The study proposes a novel application of a~     therapeutic for this disease. A better understanding of the initiating insult and natural~     progression of SSc vasculopathy is needed in order to develop therapeutics with a goal of~     curing/treating the underlying disease. This project has the potential to impact not only~     Veterans with SSc, but also those with vascular abnormalities including digital ulcers, PAH,~     and renal crisis. This proposal represents a potential major therapeutic advance for our~     Veterans with SSc.~   "
79144|NCT02530983|"~     The Mayo Clinic Conduit Report Card Questionnaires have been created in order to have a~     consistent evaluation tools for patients undergoing esophagectomy or esophageal~     reconstruction in order to standardize and validate outcome measures. Data will be used to~     establish the validation of the Mayo Clinic Conduit Report Card Questionnaires. Data will~     also lead to the establishment of normal or expected scores for patients undergoing each~     type of esophagectomy procedure~   "
79145|NCT02530970|"~     The objective of the SECURE Study is to actively gather additional information on the use of~     the CorMatrix® CanGaroo ECM® Envelope in a post market observational study.~   "
79146|NCT02530957|"~     Tracheal intubation is a challenging procedure in Intensive Care Unit (ICU), associated with~     severe life threatening complications. To decrease these complications, preoxygenation is~     recommended. Non invasive ventilation (NIV) increase effectiveness of preoxygenation,~     applying a positive end expiratory pressure (PEEP). High-flow nasal cannula oxygen (HFNC)~     improves oxygenation by increasing end-expiratory lung volume and has a potential of apneic~     oxygenation. The association of NIV and HFNC for preoxygenation in hypoxemic ICU patients has~     never been evaluated. The aim of this study is to determine if HFNC combined to NIV could~     have therapeutic advantages over NIV alone for preoxygenation in the ICU patients intubated~     for hypoxemic acute respiratory failure.~   "
79147|NCT02530944|"~     The goal of this new lupus research study is two-fold: first, to understand the genetic~     associations found between people's DNA and this disease, and second, to apply this~     understanding to drug development efforts with the investigator's partners at Pfizer.~   "
79148|NCT02530931|"~     -  This prospective study aims to better characterize inner ear's perilymphatic structures~          with Magnetic Resonance Imaging using contrast media and delayed injection in patient's~          with Meniere's disease.~        -  MR Perfusion Imaging will be assess in both cochlea as well~        -  Primary auditory brain pathways will be evaluated through MR diffusion imaging~   "
79149|NCT02530918|"~     The purpose of this study is to test DS-7080a, a monoclonal antibody, as a new treatment for~     neovascular age-related macular degeneration (AMD) and diabetic macular edema (DME). The~     hypothesis of the study is that DS-7080a is safe and shows preliminary efficacy in patients~     with these conditions either alone or in combination with ranibizumab. This study is~     organized into 3 Parts: Part 1 Dose Escalation in AMD participants, Part 2 Dose Expansion in~     AMD participants, and Part 3 Dose Expansion in DME participants.~      In Part 1, participants will be enrolled into 3 sequential, ascending dose-level cohorts in~     non-randomized uncontrolled manner with the main purpose to determine the recommended dose.~      In Part 2, participants will be randomized to 1 of 3 arms of either monotherapy with DS-7080a~     or monotherapy with ranibizumab, which is an active control, or combination therapy of~     DS-7080a plus ranibizumab (ranibizumab will be administered 30 minutes prior to DS-7080a).~      In Part 3, subjects with DME will be assigned to 1 of 2 arms of either monotherapy with~     DS-7080a or monotherapy with ranibizumab. DS-7080a or ranibizumab will be administered 3~     times: on Baseline/Day 1, Day 29, and Day 57.~      Both Parts 2 and 3 will consist of 8 visits including a 14-day screening phase, an 84-day~     treatment period, and a 28-day follow-up period.~   "
79150|NCT02530905|"~     This is a first-in-human dose-titration and open-label extension study to assess safety,~     tolerability, and pharmacokinetics of SRP-4045 in advanced-stage Duchenne muscular dystrophy~     (DMD) patients with deletions amenable to exon 45 skipping.~   "
79151|NCT02530892|"~     The purpose of this study is to determine whether oocyte and embryo mechanical properties~     measured during in vitro fertilization can predict embryo development outcomes and clinical~     pregnancy.~   "
79152|NCT02530879|"~     This study will be a prospective, randomized, unblinded but controlled trial. Patients~     presenting to the Otolaryngology clinic who are diagnosed with laryngopharyngeal reflux~     disorder related dysphonia and meet inclusion criteria will be eligible to enroll in the~     study. Subjects will be randomized to one of three treatment arms, voice therapy, anti-reflux~     therapy, or a combination of voice therapy and anti-reflux therapy. Reflux symptom index~     (RSI) scores, reflux finding scores (RFS), voice handicap index-10 (VHI-10) scores, and~     consensus auditory perceptual evaluation-voice (CAPE-V) scores will be compared prior to~     initiation of therapy as well as at 1, 2, and 3 months following initiation of treatment.~   "
79153|NCT02530866|"~     This is a randomized clinical pilot trial designed to assess the feasibility of randomizing~     obese women with GDM to lower glycemic thresholds compared to standard care. Maternal and~     cord blood metabolic profiles, neonatal body composition, and maternal sleep quality and~     duration will also be compared between groups.~   "
79154|NCT02530853|"~     This is a randomized clinical trial with blinded, multi-center, involving the Federal~     University of in Rio de Janeiro(UFRJ), through the School of Nursing Anna Nery, as a~     proponent and research coordinator; and as a collaborative educational institutions, the~     Federal University of in Espirito Santo, represented by the Department of Nursing; and the~     Higher School of Sciences of the Santa Casa de Misericordia of Vitoria, developed by building~     doctorate thesis as a final product of the research.~   "
79155|NCT02530840|"~     In the IMPACT project, the investigators want to improve adherence and commitment to~     treatment.~   "
79156|NCT02530827|"~     Background: Several studies have reported increased resting energy expenditure (REE) in~     people living with HIV/AIDS possibly due to changes in body composition that occurs in HIV~     lipodystrophy syndrome.~      The aim of this study was to evaluate the influence of the use of lipid-lowering drugs in~     resting energy expenditure (REE) and total energy expenditure (TEE) in patients seropositive~     for HIV in treatment of lipodystrophy.~   "
79174|NCT02530593|"~     All patients presenting at participating hospitals during the recruitment period with a newly~     diagnosed colon cancer, regardless of stage and planned treatment, will be eligible for~     inclusion. They will answer a questionnaire on health related quality of life, physical~     symptoms, functional impairments and socioeconomic status at diagnosis and after 12, 36~     months. Clinical data including recurrence, survival, surgical treatment, oncologic result~     (pathology report) and adjuvant treatment will be collected from the Swedish ColoRectal~     Cancer Registry (SCRCR)~   "
79301|NCT02528942|"~     The proposed study is in the field of thoracic radiation oncology where radiation therapy is~     used to treat lung cancer. The primary objective of the early phase clinical trial will be to~     evaluate the safety of performing functional avoidance radiation therapy for lung cancer~     patients using 4D computed tomography (4DCT) ventilation imaging.~   "
79157|NCT02530814|"~     In the Lake Apopka, Florida area for over 50 years starting in the 1940s, organochlorine~     pesticides (OCPs) including 4,4'-dichlorodiphenyltrichloroethane (DDT), dieldrin, chlordane,~     toxaphene and more recently methoxychlor were sprayed on farmlands in order to control pests~     and to improve crop harvests. For most of those years, the farmworkers were exposed to the~     pesticides as part of their work. Because of their lipophilic (fat soluble) nature, these~     organochlorine pesticides (OCPs) are readily taken up into the body and not readily~     eliminated. Therefore, they can be detected in exposed individuals for many years after the~     exposure. There is some evidence that certain OCPs can cause or exacerbate medical problems~     in sensitive individuals. For example, exposure to some OCPs has been associated with~     development of Parkinsonism. Exposure to other OCPs has been associated with development of~     lupus erythematosus, an auto-immune disease. Other adverse effects of exposure to OCPs are~     endocrine disruption because some OCPs mimic estrogens and others mimic androgens, or may~     have mixed interactions with steroid receptors.~      In this research study the investigators aim is to test the blood from former farmworkers~     during the 1940s through the late 1970s who reside in the Lake Apopka area for OCPs and for~     the auto-antibodies. In addition, questionnaires will provide insight on their health status~     and health concerns.~   "
79158|NCT02530801|"~     Pterygium is a common eye disease. Its mechanism remains unknown but studies suggest that it~     is related to exposure to ultraviolet rays and ocular dryness. Pterygium affects vision by~     causing astigmatism and may encroach on cornea (transparent part of the eye) affecting~     vision. It could cause ocular irritation and can be cosmetically unacceptable especially when~     inflamed.~      Recurrence is the most common outcome of pterygium excision. Recurrence rates of pterygium~     vary from 10 to more than 80%. Recurrence can be detected first in the conjunctiva(skin of~     your eye), before advancing on to the cornea. Treating the recurrent pterygium before the~     cornea gets involved avoids repeat surgery, which is difficult and is associated with more~     scarring. To avoid repeated surgeries, the activity of a recurrent pterygium should be~     stopped before it progresses to true recurrence.~      Several studies attributed the recurrence pf pterygium to the increase of substances as~     vascular endothelial growth factor(VEGF) and fibroblast growth factor. Avastin (Anti-VEGF)~     and 5 fluorouracil(5FU) (antimetabolite) are medications that suppress the formation of VEGF~     and fibroblast growth factor.~      Studies have shown that the subconjunctival injection of 5 F and Avastin into the recurring~     pterygium has been both safe and effective in treatment of recurrent pterygium.~      In many cases, vascularization and inflammation were controlled by subconjunctival Avastin,~     providing evidence for a role of VEGF in pterygium formation. 5FU is widely used in~     ophthalmology because of its anti-scarring properties.~      The other option for treatment of recurrent pterygium is surgery. Recurrent pterygium is a~     challenging condition that usually resists conventional surgery and its rate of recurrence~     after surgery is high. Moreover, recurrent pterygium surgery is usually accompanied by~     scarring, more risk of intra and post- complications This study aims to generate data to~     inform further studies towards establishing Avastin and 5 fluouracil as treatment modality~     for recurrent pterygium.~   "
79159|NCT02530788|"~     This planned pilot study is a monocentric, prospective, double-blind randomized and placebo~     controlled clinical study. The SOS-LVAD Trial can be assigned to the clinical Phase III.~      The aim of the present trial is to provide the scientific rationale for a large multicenter~     clinical trial, investigating the effects of perioperative high dose selenium supplementation~     in high-risk cardiac surgical patients undergoing complicated open heart surgery with~     prolonged time on cardiopulmonary bypass (CPB) and LVAD Implant. The investigators~     hypothesize that the therapeutic strategy tested in this randomized trial may contribute to a~     faster independency from life-sustaining technologies in the ICU and a decrease of~     postoperative morbidity and mortality. Before proceeding to the large-scale, definitive~     trial, the investigators propose to conduct a pilot study of the definitive randomized trial,~     to determine the feasibility of the study protocol.~   "
79160|NCT02530775|"~     The purpose of this study is to determine whether instrumented lumbar fusion provides~     superior clinical outcomes in comparison to non-instrumented fusion in patients with static~     degenerative spondylolisthesis.~   "
79161|NCT02530762|"~     The study will assess the gastrointestinal tolerability of a single serving of a novel~     dietary fiber at three different dose levels in generally healthy men and women. Double-blind~     controlled, cross-over clinical trial with negative (no added fiber) and positive controls.~     Single dose, with 24 hours data collection and 1 week wash-out between cross-overs. 45~     randomized, generally healthy men and women, 18-54 y, BMI higher or equal to 18.5 and smaller~     or equal to 39.99 kg/m2. Novel dietary fiber ingredient and positive control will be~     delivered in 240 ml beverages.~   "
79162|NCT02530749|"~     Frailty as an adjunct to preoperative assessment of neurosurgical patients has never been~     evaluated. This study aims to determine if frailty predicts neurosurgical complications in~     brain tumor patients and enhances current perioperative risk models.~   "
79163|NCT02530736|"~     This study measures the 4 metre gait speed (4MGS) test in patients with Idiopathic Pulmonary~     Fibrosis (IPF). The investigators are interested to see whether usual walking speed in IPF~     patients changes following pulmonary rehabilitation and if it changes, what is the smallest~     change that is meaningful to patients.~   "
79164|NCT02530723|"~     Extending quality of life and attenuating functional decline is paramount in older adults.~     This study investigates the effects of low-intensity power-training in older women and its~     effects on functional outcomes.~   "
79165|NCT02530710|"~     Randomized, double-blind, placebo-controlled, dose-escalation study in healthy male and~     female volunteers. Subjects will be randomly assigned to 1 of 7 treatment cohorts (Cohorts 1~     - 7) of 8 subjects each, to receive either Q203 or placebo (6 active treatment : 2 placebo)~     in a fasting state.~      Dose escalation to the next cohort may be considered when at least 6 out of 8 subjects, in a~     cohort, completes all procedures and none of the subjects has a clinically significant~     adverse event (AE) that is being followed, or at the discretion of the PI if no drug-related~     serious adverse events (SAEs) have occurred.~      A food effect cohort will be enrolled to test administration of Q203 in a fed state, at 100~     mg dose level (this dose level may change based on PK analysis results). Subjects who~     received 100mg dose in a fasting state will return and receive the second dose, with food.~      Subjects will be followed up for AEs, SAE or pregnancy for 30 days postdrug administration.~   "
79166|NCT02530697|"~     Mucocutaneous leishmaniasis is endemic in the central region of Brazil and other countries~     worldwide. The standard treatment with meglumine antimoniate has a high rate of important~     adverse effects. This interventional study consists in a randomized clinical trial to access~     efficacy and safety of the association of miltefosine and pentoxifylline compared to~     meglumine antimoniate and pentoxifyline.~   "
79185|NCT02530450|"~     The purpose of this study is to determine if the use of continuous glucose monitoring in a~     practical outpatient clinic setting in children with poorly controlled diabetes will lead to~     improved blood sugar control.~   "
79302|NCT02528929|"~     To evaluate the effects of a gluten-free diet in irritable bowel syndrome.~   "
79167|NCT02530684|"~     It is critical to improve our understanding of knee osteoarthritis and to design better~     therapeutic options for this disease. The function of the knee during walking is an important~     factor in the development and progression of the disease. Many models of insoles that can be~     inserted in regular shoes with the objectives of improving the function of the knee are~     available on the market without prescription. Prior studies on these insoles failed to report~     clear benefits for the patients, mainly because the results varied strongly between persons.~     Walking is a complex tasks and it is well known that everybody develops his/her individual~     way of walking (ie., there are subtle but very important differences in the function of the~     knee). This observation and the fact that patient responses could vary between individuals~     suggest that using the same standard insoles with all patients might not be appropriated.~     This further suggests that care could be greatly improved if it was possible to identify~     patients that would respond positively to a model of insoles. Unfortunately, while several~     randomized controlled trials were conducted on these insoles for knee osteoarthritis, there~     is a paucity of data regarding their effects on the ambulatory function of the knee.~     Therefore, this study aims to improve the understanding regarding the effects of insoles~     freely available on the market in terms of knee mechanics during walking and its relation~     with quality of life. This study will test the hypotheses that (i) insoles have an effect on~     the static and dynamic lower-limb function and (ii) that benefits perceived by the patients~     are related to the mechanical effects produced by the insoles.~   "
79168|NCT02530671|"~     Background: Clinical studies have explored the relationship between toothbrushing and the~     development of recession, but relevant recession data for the multi-directional power~     toothbrush (PT) are lacking. The aim of this study was to evaluate the effect of brushing~     with either a multi-directional power toothbrush (PT) or an ADA (American Dental Association)~     reference manual toothbrush (MT) on pre-existing mid-buccal gingival recession (Pre-GR) over~     12 months~      Methods: This was a 12-month, prospective, single-blind, parallel-group, randomized~     controlled clinical study. Healthy participants without periodontitis but with at least 2~     teeth showing Pre-GR ≥2mm were randomized to a group either brushing with a MT or a PT. The~     primary outcome parameter was the change at sites with Pre-GR ≥2mm. All recession~     measurements were performed by one calibrated examiner at baseline, 6 and 12 months.~     Secondary outcomes were changes of recession at all buccal sites (with or without pre-GR),~     changes in the percentage of recession sites demonstrating a change of ≥1mm as well as~     changes in pocket probing depths.~   "
79169|NCT02530658|"~     The development of next generation sequencing (NGS) techniques, including whole genome (WGS),~     exome (WES) and RNA sequencing has revolutionized the ability of investigators to query the~     molecular mechanisms underlying tumor formation. Through the Pediatric Cancer Genome Project~     (PCGP), investigators at St. Jude Children's Research Hospital (SJCRH) have successfully used~     NGS approaches to evaluate more than 1,000 pediatric cancers ranging from hematologic~     malignancies to central nervous system (CNS) and non-CNS solid tumors. From these and related~     studies, it has become clear that genomic approaches can accurately classify tumors into~     distinct pathologic and prognostic subtypes and detect alterations in cellular pathways that~     may serve as novel therapeutic targets. Collectively, these studies suggest that by~     characterizing the genomic make-up of individual tumors, investigators will be able to~     develop personalized and potentially more effective cancer treatments and/or preventive~     measures.~      Despite recent advances, NGS approaches are not yet routinely used as part of clinical care~     due to their high cost and technical complexity, as well as the many challenges related to~     data analysis and translation to the clinical setting. The overarching goal of this protocol~     is to establish and test processes by which NGS technologies, including WGS, WES and RNA~     sequencing, can be offered to pediatric oncology patients undergoing treatment at SJCRH.~      This is a non-therapeutic study examining the feasibility, acceptance and impact of clinical~     WGS, WES and RNA sequencing in a pediatric oncology setting. Investigators anticipate a~     sample size of approximately 400 patients and 400-800 biological parents.~   "
79170|NCT02530645|"~     A pilot trial (N=60) will be conducted to test the feasibility and preliminary effectiveness~     of OnTrack (a smartphone application to self-monitor substance use and sexual behaviors among~     homeless young adults) plus a brief motivational intervention (BMI), in comparison to~     treatment as usual (TAU) at Covenant House New York (CHNY) for those with substance abuse~     problems and who engage in risky sex. Following referral, screening, and eligibility~     determination, 60 participants will complete informed consent and be randomly assigned to one~     of two conditions: 1) TAU or 2) OnTrack + BMI. All participants will be assessed at baseline,~     2 weeks, 4 weeks, and 6 weeks after baseline to evaluate alcohol consumption, marijuana use,~     HIV sexual risk behaviors, and other relevant variables.~   "
79171|NCT02530632|"~     Effects of different general anesthetics on peripheral microcirculation.~   "
79172|NCT02530619|"~     The purpose of this study is to evaluate the safety of alisertib and its effect, bad and/or~     good, on acute megakaryoblastic leukemia (AMKL) or myelofibrosis (MF). The study drug,~     alisertib, is an investigational drug. An investigational drug is one that has not been~     approved by the U.S. Food and Drug Administration (FDA). Alisertib has shown evidence in the~     lab that it may have an effect on a type of cell that produces platelets. This cell is called~     a megakaryocyte and it is known to be defective (doesn't work well) in both AMKL and MF.~   "
79173|NCT02530606|"~     This pilot clinical trial studies how well photoacoustic imaging works in detecting ovarian~     or fallopian tube cancer. Photoacoustic imaging is an imaging method that uses lasers to~     light up tissue, and then converts the light information into ultrasound images.~     Photoacoustic imaging can provide images of the structure of tissues, as well as their~     function and the levels of molecules, such as the flow of blood in blood vessels and the~     level of oxygen in the blood. Photoacoustic imaging may help doctors determine whether a mass~     is benign (non-cancerous) or cancerous based on the molecular differences between cancer and~     normal tissue. It may be more accurate and less expensive than other imaging methods, and~     does not expose patients to radiation.~   "
79303|NCT02528916|"~     Nociceptin/Orphanin is a novel opioid peptide system associated with inflammatory response.~     Currently is it uncertain as to the presence of absence of nociceptin in synovial fluid of~     patients. Nociceptin levels will be measured pre-operatively and post-operatively in plasma~     levels of patients receiving primary total knee arthroplasty. Nociceptin levels will also be~     measured in synovial fluid levels prior to surgical manipulation.~   "
79175|NCT02530580|"~     GABA (gamma-aminobutyric acid) is the main inhibitory neurotransmitter in the human brain.~     For years, drugs that enhance its effects (e.g., benzodiazepines such as diazepam/Valium)~     have been used to treat various diseases such as epilepsy, insomnia, anxiety or movement~     disorders. However, the use of these medications is often compromised because of their side~     effects, such as sleepiness, memory problems, and addiction.~      Therefore, effort has been made to develop drugs that act more selectively in the brain to~     exert the positive therapeutic effects and are devoid of the unwanted side effects. AZD7325~     is one of these drugs. It has been tested in more than 700 people and so far proved to be~     generally well tolerated. Positron emission tomography (PET) study in humans demonstrated~     that AZD7325 binds to GABA A receptors in the brain after a single dose. Early clinical~     studies have shown that it has less sedative and cognitive adverse events as compared with a~     benzodiazepine lorazepam.~      The investigators now wish to evaluate if effects of AZD7325 can be objectively measured in~     healthy volunteers and to establish which of the drug's outcomes could be utilised for~     further studies in patients with neurological diseases.~      The investigators are especially interested in the effects of AZD7325 on manual dexterity and~     skin sensation of the hand. This can be assessed by a number of simple non-invasive tests of~     object manipulation and detection of different sensory stimuli such as touch, vibration, or~     temperature. Recent studies show that healthy individuals who performed better in similar~     tasks had more GABA in relevant areas of their brain. If performance in these tasks in~     healthy volunteers can be improved by enhancing GABA effects in the brain with AZD7325, this~     would create the grounds for the use of this medication to treat symptoms of certain~     neurological disorders in which motor control and sensation of the hand is impaired (e.g.,~     polyneuropathy).~   "
79176|NCT02530567|"~     The objective of this research is to study the correlation between the portosystemic pressure~     gradient and azygos blood flow measured by MRI.~   "
79177|NCT02530554|"~     Pilot study to evaluate and compare activity of preoperative preparation with comparator~   "
79178|NCT02530541|"~     Pilot study to evaluate and compare activity of preoperative preparation with comparator~   "
79179|NCT02530528|"~     Pilot study to evaluate and compare activity of preoperative preparation with comparator.~   "
79180|NCT02530515|"~     Patient's immune systems are often damaged by chemotherapy or by CLL. Researchers want to~     learn if giving T-cells (immune cells) that have been expanded and specially processed in the~     laboratory (activated) will help CLL patients' immune systems recover after chemotherapy.~     This may help lower the chance of infections.~      The goal of this clinical research study is to learn if an activated T-cell infusion, when~     given with or without lenalidomide, can help to restore patients' immune systems when given~     after chemotherapy (rituximab and fludarabine with cyclophosphamide or bendamustine). The~     safety of this treatment combination will also be studied.~      Researchers also want to learn if the activated T-cells may also be able to kill cancer~     cells.~   "
79181|NCT02530502|"~     The purpose of phase I trial is to determine the safest, most effective dose of MK-3475~     (pembrolizumab), when used with radiotherapy and temozolomide for treating newly diagnosed~     patients with glioblastoma (GBM). Phase II trial will evaluate if MK-3475 used in combination~     with temozolomide and radiation followed by radiation and temozolomide to see if this is~     better than using radiation and temozolomide alone. Temozolomide binds to the~     deoxyribonucleic acid (DNA), changes it, and triggers the death of tumor cells. MK-3475 is an~     investigational drug, it is not currently approved by the Federal Drug Administration (FDA)~     for use in treating GBM but it is approved for treating melanoma. MK-3475 works by targets~     the local tumor immune-protection in solid tumors. It is hoped the addition of MK-3475 to the~     usual treatment for GBM will improve the current treatment.~   "
79182|NCT02530489|"~     The goal of this clinical research study is to learn if receiving atezolizumab and abraxane~     (nab-paclitaxel) in combination before surgery and atezolizumab alone after surgery can help~     to control breast cancer. The safety of this study drug combination will also be studied.~      This is an investigational stYou are being asked to take part in this study because you have~     breast cancer that has not responded to chemotherapy, and your doctor thinks it is unlikely~     to respond to additional standard chemotherapy when given before surgery.~      The goal of this clinical research study is to learn if receiving atezolizumab and abraxane~     (nab-paclitaxel) in combination before surgery and atezolizumab alone after surgery can help~     to control breast cancer. The safety of this study drug combination will also be studied.~      This is an investigational study. Atezolizumab is not FDA approved or commercially available.~     It is currently being used for research purposes only. Nab-paclitaxel is FDA approved and~     commercially available for the treatment of metastatic (has spread) breast cancer. The study~     doctor can explain how the study drug combination is designed to work.~      Up to 37 participants will be enrolled in this study. All will take part at MD Anderson.~      udy. Atezolizumab is not FDA approved or commercially available. It is currently being used~     for research purposes only. Nab-paclitaxel is FDA approved and commercially available for the~     treatment of metastatic (has spread) breast cancer. The study doctor can explain how the~     study drug combination is designed to work.~      Up to 37 participants will be enrolled in this study. All will take part at MD Anderson.~   "
79183|NCT02530476|"~     There are 2 parts to this study: Part 1 (dose escalation) and Part 2 (dose expansion).~      The goal of Part 1 of this clinical research study is to find the highest tolerated dose of~     the combination of selinexor (KPT-330) and sorafenib (Nexavar) that can be given to patients~     with FLT3-ITD and -D835 mutated acute myeloid leukemia (AML) or FLT3-mutated high-risk~     myelodysplastic syndrome (MDS).~      The goal of Part 2 of this study is to learn if the dose found in Part 1 can help to control~     the disease.~      The safety of the drug combination will also be studied in both parts of this study.~      This is an investigational study. Sorafenib is FDA approved and commercially available to~     treat hepatocellular cancer. Selinexor is not FDA approved or commercially available. It is~     currently being used for research purposes only. The combination of selinexor and sorafenib~     to treat FLT3-mutated AML and high-risk MDS is investigational.~      The study doctor can explain how the study drugs are designed to work.~      Up to 52 participants will take part in this study. All will be enrolled at MD Anderson.~   "
79184|NCT02530463|"~     The goal of this clinical research study is to learn if nivolumab and/or ipilimumab, with or~     without azacitidine, are safe to give to patients with MDS. Researchers also want to learn if~     the study drug combinations can help to control the disease.~      This is an investigational study. Nivolumab and ipilimumab are not FDA approved or~     commercially available for the treatment of MDS. Nivolumab and ipilimumab are each approved~     for the treatment of melanoma. Their use in MDS is investigational. Azacitidine is approved~     by the FDA for the treatment of MDS. The use of these drugs in combination is~     investigational.~      Up to 120 participants will be enrolled in this study. All will take part at MD Anderson.~   "
79186|NCT02530437|"~     The goal of Phase 1B of this clinical research study is to find a dose of Taladegib that can~     be given safely with the chemotherapy drugs carboplatin and paclitaxel and radiotherapy to~     patients with esophageal or gastroesophageal junction cancer.~      The goal of Phase 2 of this clinical research study is to learn if Taladegib given with~     chemoradiation can help to control the disease. The safety of this treatment combination will~     continue to be studied.~      This is an investigational study. Taladegib is not FDA approved or commercially available. It~     is currently being used for research purposes only. The study doctor can explain how the~     study drug is designed to work. The combination of carboplatin, paclitaxel, and radiation is~     a standard treatment for cancer of the esophagus and gastroesophageal junction.~      Up to 66 participants will be enrolled in this study. All will be enrolled at MD Anderson.~   "
79187|NCT02530424|"~     This is a multicenter neoadjuvant trial conducted under the sponsorship and overall trial~     management of the Fondazione Michelangelo in Italy.~      Women with a diagnosis of invasive unilateral non metastatic HER2-positive and ER-positive~     breast cancer suitable for neoadjuvant therapy.~      Patients in this study will receive: Trastuzumab+Pertuzumab+Palbociclib+Fulvestrant (HPPF)~      Trastuzumab 8 mg/kg loading dose IV, then 6 mg/kg IV q.3 wks (repeat for a total of 6~     administrations) Pertuzumab 840 mg loading dose IV, then 420 mg IV q. 3 wks (repeat for a~     total of 6 administrations) Palbociclib 125 mg po q.d. x 21 q. 4 wks (= 1 cycle; repeat for a~     total of 5 cycles) Fulvestrant will be given intra-muscle at the dose of 500 mg every 4 weeks~     (repeat for 5 times) with an additional 500 mg dose given two weeks after the initial dose~     (total administrations including the additional one = 6)~      The total duration of neoadjuvant palbociclib (5 cycles every 4 weeks) and fulvestrant (5~     administrations every 4 weeks plus the additional dose given two weeks after the initial~     dose) was selected to match as closely as possible the total duration of the six planned~     3-weekly administrations of trastuzumab and pertuzumab~      Definitive surgery will be performed not earlier than 14 days and not later than 28 days~     after the last dose of any of the drugs in the combination reported above~      After completion of the neoadjuvant and surgical treatment patients will receive irradiation~     as locally acceptable.~      Patients will also continue to receive systemic drug therapy including chemotherapy, and~     standard HER2 treatment until completion of full 1 year and endocrine therapy according to~     local guidelines at the Investigator's discretion.~   "
79188|NCT02530411|"~     A randomised double blind placebo controlled phase II study of fulvestrant with or without~     the addition of vandetanib as treatment for patients with metastatic breast cancer resistant~     to aromatase inhibitor therapy.~   "
79189|NCT02530398|"~     To evaluate the tolerance and safety of cinobufacini injection intraperitoneal treatment on~     digestive system cancer patients with malignant ascites, and propose dosage regimens for~     future clinical trials. The clinical trial is divided into two parts, including single and~     successive administration.~   "
79190|NCT02530385|"~     The purpose of this study is to study the impact of gut bacteria on weight. Fecal microbiota~     transplantation (FMT) transfers intestinal bacteria by a stool transplant from a healthy,~     lean person to a person with obesity.~   "
79191|NCT02530372|"~     The study will evaluate safety and effectiveness of the UriCap-F, a non-invasive urine~     collection device for women, in hospitalized patients who would otherwise be treated with an~     indwelling catheter, pads or diapers.~   "
79192|NCT02530359|"~     Patients with Septic AKI will be randomized in three arms, group PFD 1,200 will receive PDF~     600mg every 12 hrs per mouth, group PDF 600 will receive PFD 600mg in the morning and placebo~     equivalent at night and Group Placebo will receive placebo every 12 hrs, all for 7 days, all~     receive conventional treatment KDIGO guides. We analyze the recovery of renal function as a~     primary objective.~   "
79193|NCT02530346|"~     This study will help determine wether mechanical bowel preparation before a colostomy closure~     is necessary in pediatric population, in order to avoid surgery related complications~     (surgical site infection and anastomosis leakage).~      Half of the population will go through the mechanical bowel prep before colostomy closure and~     the other half won´t. Complications rate will be compared among both groups.~   "
79194|NCT02530333|"~     Anterior cruciate ligament injury programs are less successful in women's basketball than~     soccer players, yet the reason for this discrepancy is unknown. Thus, this study will recruit~     high school aged girl's basketball and soccer players, randomized teams into control and~     experimental groups, administer an ACL injury prevention program in the experimental group~     and compare the two groups on their lower extremity biomechanics before and after completion~     of the program. Biomechanical analyses will help determine the extent to which women's~     basketball and soccer players respond differently to a uniform injury prevention program, and~     whether this prevention program provides an adequate stimulus to improve lower extremity~     biomechanics during basketball-specific tasks.~   "
79195|NCT02530320|"~     This multicenter, open-label, phase II trial aims to assess the safety and efficacy of~     palbociclib in adult patients with Oligodendroglioma or recurrent oligoastrocytoma anaplastic~     with the activity of the protein RB preserved.~   "
79196|NCT02530307|"~     This is a randomized, double-blind, placebo-controlled parallel group outpatient study that~     will utilize standard stroke rehabilitation outcome measures, as well as fMRI techniques in a~     subset of subjects, to evaluate the effect of HT-3951 on motor recovery and behavior in~     medically stable subjects following ischemic stroke.~   "
79197|NCT02530294|"~     The study is a randomized, double-blind, vehicle controlled, parallel group study, designed~     to assess the efficacy and safety of DRM04 Topical Wipes, once daily, compared to vehicle in~     subjects with axillary hyperhidrosis.~   "
79198|NCT02530281|"~     The study is a randomized, double-blind, vehicle controlled, parallel group study, designed~     to assess the efficacy and safety of DRM04 Topical Wipes, once daily, compared to vehicle in~     subjects with axillary hyperhidrosis.~   "
79199|NCT02530268|"~     This prospective, non-interventional, research registry is designed to study the comparative~     effectiveness and comparative safety of approved treatments for PsA-SpA in a cohort of~     patients cared for by rheumatologists across North America. Secondary objectives include~     analyzing the epidemiology and natural history of the disease, its comorbidities, and current~     treatment practices.~   "
79304|NCT02528903|"~     This is a Phase 1, randomized, double-blind, placebo-controlled, single-ascending dose study~     in healthy volunteers to investigate the safety, tolerability, and pharmacokinetics (PK) of~     MHAB5553A.~   "
79200|NCT02530255|"~     A method of detecting amyloid in the retina has been developed. A specially designed retinal~     camera will directly visualze and record retinal amyloid and via image processing will~     generate a number: the retinal amyloid index (RAI). The amount of retinal amyloid correlates~     with cerebral amyloid and has a predictive value in Alzheimer's disease.~      Telomere attrition accounts for cellular aging and is felt to have a pivotal role in~     Alzheimer's disease. The investigators plan to screen individuals to select those having~     retinal amyloid then evaluate an oral telomerase activator to determine if its use can alter~     the RAI over time compared to placebo.~   "
79201|NCT02530242|"~     Modify the design of the CoSense device (Model C20112, currently cleared by the FDA for ETCO~     (end-tidal carbon monoxide) monitoring to improve accuracy and consistency under temperature~     conditions encountered in countries with high prevalence of SCD (Sickle Cell Disease).~   "
79202|NCT02530229|"~     The purpose of this study is to analyze pre- and intra-operative joint aspirates of native~     joints and joints with suspicion of periprosthetic joint infection (PJI) of the hip, knee and~     shoulder acquired in clinical routine. Joint aspirates are then analyzed with new diagnostic~     methods (microcalorimetry, PCR, alpha-defensin, etc.). Diagnostic speed and accuracy of these~     methods is compared to standard diagnostic methods in clinical routine, such as blood~     cultures of joint aspirates, cell count/differential, intra-operative tissue culture and~     histology and sonication.~   "
79203|NCT02530216|"~     Healthcare delivery now mandates shorter visits with higher documentation requirements,~     undermining the patient-provider interaction. Electronic health records (EHRs) have the~     potential to improve outcomes and quality of care in this pressured environment, and are~     endorsed by the Patient Protection and Affordable Care Act (ACA) and Health Information~     Technology for Economic and Clinical Health (HITECH) Act as an important mechanism to support~     value-based healthcare. However, EHR systems were principally designed to support the~     transactional needs of administrators and billers, less so to nurture the relationship~     between patients and their providers. The purpose of this research is to identify ways to use~     EHRs to support clinical gastroenterologists and their patients while meeting the meaningful~     use requirements of the HITECH Act.~      To improve clinic visit efficiency and meet criteria for meaningful use, investigators~     developed a patient-provider portal (P3) that systematically collects patient symptoms using~     a computer algorithm called Automated Evaluation of Gastrointestinal Symptoms (AEGIS). AEGIS~     utilizes computerized adaptive testing (CAT) to guide patients through questions drawn from a~     library of over 300 symptom attributes measuring the timing, severity, frequency, location,~     quality, and character of their GI symptoms, along with relevant comorbidities, family~     history, and alarm features. The system then automatically translates the patient report~     into a full narrative HPI available for use by GI providers in an EHR.~      In a cross-sectional study in the American Journal of Gastroenterology comparing AEGIS versus~     physician-documented HPIs, investigators found that blinded physician reviewers perceived~     that AEGIS HPIs were of higher overall quality, better organized, and more succinct,~     comprehensible, complete and useful compared to HPIs written by physicians during usual care~     in academic GI clinics. In the current study, investigators aim to evaluate~     computer-generated HPIs prospectively on a wider scale in diverse academic and~     community-based settings. Moreover, investigators aim to test an enhanced AEGIS intervention~     that ties patient HPIs to an individualized education prescription which guides the patient~     through a library of multi-media educational materials on GI symptoms, conditions, and~     treatments.~   "
79204|NCT02530203|"~     Patients will be randomized to control and spinal cord stimulation arm (SCS) to investigate~     the effect of SCS on the occurrence of post-operative atrial fibrillation in the five days~     after surgery.~   "
79205|NCT02530190|"~     The study is a randomized clinical trial examining the effectiveness of massage and~     intermittent pneumatic compression on recovery from a 161-km ultramarathon.~   "
79206|NCT02530177|"~     The purpose of this study is to see how many patients develop hair, skin and nail changes due~     to cancer treatments. The investigators would like to study the clinical factors, genetic~     markers, and impact on patients' health-related quality of life to learn more about who is at~     greater risk. We trust that the study will improve our understanding of how cancer patients~     feel about their skin, hair, and nail conditions. This information will help us determine the~     burden on breast cancer patients and survivors. It will also help us learn how to prevent~     these conditions and it may improve the way we treat them and counsel patients.~   "
79207|NCT02530164|"~     Major depressive disorder (MDD) is a common, recurrent, and frequent chronic disorder.~     Treatment is often challenging; an estimated 20-40% of patients do not benefit sufficiently~     from existing antidepressant interventions including trials of medication and psychotherapy.~     A 15-25% of patients manifest a chronic, treatment-resistant course of illness, resulting in~     a need for additional treatment options. Brain stimulation techniques are considered as a~     promising therapeutic approach in affective disorders like MDD. Transcranial direct current~     stimulation (tDCS) is a non-invasive brain stimulation method that has been largely~     investigated in experimental neurosciences and tDCS of the prefrontal cortex (PFC) has been~     proposed as novel treatment in MDD. In the largest 2x2 factorial randomized controlled trial~     in MDD to date, Brunoni et al. (2013) have shown that tDCS combined with an Selective~     Serotonin Reuptake Inhibitor (SSRI; sertraline) resulted in an antidepressant efficacy~     superior to placebo treatment, tDCS alone and sertraline alone.~      The purpose of this study is to explore the sustained efficacy and tolerability of repeated~     tDCS for the treatment of MDD. It is hypothesized that prefrontal tDCS in combination with an~     SSRI will provoke an antidepressant effect while antidepressant medication alone (sham tDCS)~     did not. This will be measured by the change from baseline in the Montgomery Åsberg~     Depression Rating Scale (MADRS) scores after 6 weeks of treatment.~      In this randomized, placebo-controlled multicenter trial (5 centers involved) patients with a~     diagnosis of MDD receive a 6-weeks treatment with prefrontal tDCS (anode over electrode~     position F3, cathode over F4, 5 sessions/week for 4 weeks followed by 2 sessions/week for 2~     weeks, 24 treatments in sum, 30min/day, 2mA intensity) or sham tDCS (frequency and duration~     correspondent active tDCS, ramp in and ramp out periods only without intermittent~     stimulation), as adjunctive treatment with a SSRI. Follow-up per patient is 3 and 6 months~     after the last tDCS treatment session. Before, during and after the treatment period~     different assessment scales will be conducted to record neuropsychological features and the~     course of the individual symptomatology.~   "
79208|NCT02530151|"~     The purpose of this study is to determine whether intraoperative (during surgery) morphine~     and clonidine hip injections are effective in postoperative pain management for patients~     undergoing hip arthroscopy.~   "
79209|NCT02530138|"~     Introduction: Currently, Nonalcoholic Fatty Liver Disease (NAFLD) is the most common liver~     disease in the world. The only approved treatment for it is lifestyle modification and weight~     loss; however, there is no evidence for patients with normal or low body mass index (BMI).~      The aim of this study is to evaluate the efficacy of symbiotic supplementation in NAFLD~     patients with normal or low BMI.~      Methods and analysis: In this randomized, double-blind, placebo-controlled clinical trial~     protocol, 21 cases and 21 controls will be individually matched based on age and sex. This 42~     patients with NAFLD will be supplemented twice daily for 28 wk with either a synbiotic or a~     placebo capsule. Both groups will be advised to follow an energy balanced diet and physical~     activity recommendations.~   "
79424|NCT02527343|"~     The purpose of this study is to evaluate the efficacy and safety of volanesorsen~     (IONIS-APOCIIIRx) given for 52 weeks in patients with Familial Partial Lipodystrophy.~     Patients will then be allowed to continue in a 2 year Open Label Extension of the study.~   "
79210|NCT02530125|"~     The purpose of this study is to evaluate pidilizumab and its effect, bad and/or good, on the~     immune system in relation to its ability to fight cancer cells. Many cancers can be brought~     to a phase called complete remission (no cancer is found) but have a chance that they may~     come back. Researchers are working to improve therapy and to find new drugs that lower the~     chance of disease coming back. This study uses a drug called pidilizumab. The drug targets~     our immune system. It can change how our immune system finds cancer cells. The drug may kill~     any remaining cancer cells that we cannot see with computed tomography (CT) scans. The drug,~     pidilizumab, is being studied in other cancers.~   "
79211|NCT02530112|"~     To identify outcome measures for cancer control in Head and Neck cancer patient populations~     at the University of Pennsylvania (HUP, PAH, Presby) by administering various functional~     outcome surveys and questionnaires about their reconstructive surgery. We hope to ultimately~     develop a QOL indicator that will reflect the impact of reconstructive surgery on patient's~     quality of life, and help with therapeutic interventions and explanation of expectations~     prior to surgery.~   "
79212|NCT02530099|"~     Often the less experienced as medical students are charged with the role as camera navigator~     and assistant during laparoscopic surgery. Camera navigation is generally considered an easy~     skill, but it requires specific psychomotor and visuospatial skills. Simulation-based~     training can improve surgical skills, but little is known on how to optimally structure a~     training program to acquire camera navigation skills. The objective of this trial is to~     examine if simulation-based laparoscopic camera navigation skills transfer to the operating~     room after practicing one of two fundamentally different laparoscopic tasks on a simulator.~     The first group practice a procedure on a virtual reality simulator, the second group~     practice camera navigation on a virtual reality simulator and the third group receive no~     training. All participants are tested as camera navigators and assistants during a procedure~     in the operating room.~   "
79213|NCT02530086|"~     A prospective randomized trial comparing non-operative management of small bowel obstruction~     due to adhesions with or without a naso-gastric tube (NGT).~   "
79214|NCT02530073|"~     The rationale for fetal therapy in severe congenital diaphragmatic hernia (CDH) is to restore~     adequate lung growth for neonatal survival.~   "
79215|NCT02530060|"~     The purpose of this study is to evaluate the pharmacokinetics (PK) of~     rilpivirine/Tenofovir/Emtricitabine (RPV/TFV/FTC) after a single-oral administration of~     Complera (the fixed-dose combination of RPV, FTC, Tenefovir disoproxil fumarate [TDF]) to~     healthy Japanese adult male participants.~   "
79216|NCT02530047|"~     The goal of this clinical research study is to find the highest tolerable dose of human~     mesenchymal stem cells with interferon beta (MSC-INFb) that can be given to patients with~     ovarian cancer and to test the safety of the MSC-INFb.~      This is an investigational study. MSC-INFb infusions for ovarian cancer is investigational.~      Up to 21 patients will take part in this study. All will be enrolled at MD Anderson.~   "
79217|NCT02530034|"~     The goal of this clinical research study is to find the highest tolerable dose of Hu8F4 that~     can be given to patients with advanced leukemia.~      This is the first study using Hu8F4 in humans.~   "
79218|NCT02530021|"~     There are many patients hospitalized for chest pain, which don't have high risk features that~     require invasive coronary angiography, but are considered intermediate risk and for which~     ischemic heart disease can not be excluded.~      The current management for these patients is to perform a non invasive test in order to~     classify their risk.~      Exercise ergometry is a commonly used non invasive test to detect ischemia. that test is~     non-invasive, and does not involve radiation or intra-venous contrast. The test is limited~     for many patients, because of un-ability to exercise, or because of non-interpetable Electro~     Cardio-Graphy (ECG).~      Heart rate variability is well known to be a marker of ischemic heart disease. Heart rate~     variability testing is a non-invasive ECG monitoring technique.~      The study design is to identify hospitalized patients who are candidates for non-invasive~     stress testing, and to monitor their heart rate variability for one hour prior to the stress~     test.~   "
79219|NCT02530008|"~     This is a cohort study of women with suspected or confirmed recurrent breast cancer, with~     accessible tumor by standard clinical biopsy, prior to starting a new therapy for recurrent~     metastatic disease. Study participants will be ascertained from the population of all persons~     greater than eighteen years of age receiving care at the clinical practices of the Rowan~     Breast Center (RBC) at the University of Pennsylvania. The overarching goal of this study is~     to identify the genetic and molecular markers of molecular evolution identified in patients~     who have progressed from a primary diagnosis of breast cancer to recurrent, metastatic~     disease. As an observational study, this study seeks to gather data regarding the molecular~     and genetic changes that a primary cancer undergoes as a patient's cancer recurs and~     ultimately progresses. We anticipate enrolling 50 women with recurrent breast cancer who meet~     eligibility requirements for this study. Participation in this study will include the~     following: a biopsy and blood collection, completion of the study questionnaire, an optional~     bone marrow aspiration, and repeat collection of blood, offer of a research biopsy and a~     optional bone marrow aspirate collection at each progression time point. The study~     participants' medical information will be updated and changes in disease status will be~     captured on a regular basis.~   "
79220|NCT02529995|"~     A Phase I, Open-Label, Two Parts Study to Assess the Safety, Tolerability,Pharmacokinetics~     and Preliminary Anti-tumour Activity of AZD9291 in Chinese Patients with Advanced Non-Small~     Cell Lung Cancer who have Progressed Following Prior Therapy with an Epidermal Growth Factor~     Receptor Tyrosine Kinase Inhibitor Agent~      Study Objective: 1, Primary Objective To characterise the pharmacokinetics (PK) of AZD9291~     and its metabolites (AZ5104 and AZ7550) after single then multiple doses of AZD9291~     administered orally once daily in Chinese patients with locally advanced or metastatic non~     small cell lung Cancer (NSCLC) who have progressed following prior therapy with an approved~     Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI) agent.~      2, Secondary objective(s) To investigate the safety and tolerability of AZD9291 when given~     orally to Chinese patients with locally advanced or metastatic NSCLC who have progressed~     following prior therapy with an approved EGFR TKI agent. To obtain a preliminary assessment~     of the anti-tumour activity of AZD9291 by evaluation of tumour response using Response~     Evaluation Criteria in Solid Tumours (RECIST) version 1.1.~   "
79221|NCT02529982|"~     Diabetes mellitus is the most common endocrine disorder, causes many complications such as~     micro- and macro-vascular diseases. Various kinds of antidiabetic drugs have been developed,~     but most of them have side effects. Recently, the use of natural plant products has gained~     more attention among scientists in order to prevent diabetic vascular complications. Curcumin~     is a natural yellow product derived from the turmeric rhizome which has shown to be non-toxic~     and exhibits various bio¬logical activities such as anti-oxidant, anti-inflammatory,~     anti-carcinogenic, and anti-diabetic effects. Curcumin is effective in reducing glycemic~     index and hyperlipidemia in rodent models and is relatively inexpensive and safe. Most of the~     studies conducted on animal model, and just a few of them are on human model. The present~     study was planned to evaluate the effects of curcumin supplementation on serum levels of~     glycemic control, lipid profile, inflammatory markers, and oxidative stress in patients with~     type 2 diabetes~   "
79222|NCT02529969|"~     Diabetes mellitus is the most common endocrine disorder, causes many complications such as~     micro- and macro-vascular diseases. Various kinds of antidiabetic drugs have been developed,~     but most of them have side effects. Recently, the use of natural plant products has gained~     more attention among scientists in order to prevent diabetic vascular complications. Curcumin~     is a natural yellow product derived from the turmeric rhizome which has shown to be non-toxic~     and exhibits various bio¬logical activities such as anti-oxidant, anti-inflammatory,~     anti-carcinogenic, and anti-diabetic effects. Curcumin is effective in reducing glycemic~     index and hyperlipidemia in rodent models and is relatively inexpensive and safe. Most of the~     studies conducted on animal model, and just a few of them are on human model. The present~     study was planned to evaluate the effects of curcumin supplementation on serum levels of~     lipid profile and inflammatory markers in patients with type 2 diabetes~   "
79223|NCT02529956|"~     To evaluate the safety of UCB4940 administered by iv infusion of a single ascending dose in~     subjects with mild to moderate plaque psoriasis.~   "
79224|NCT02529943|"~     Is there a relationship between changes in motor evoked potential latency intraoperatively~     and post-operative changes in walking function in patients undergoing spinal decompression.~   "
79225|NCT02529930|"~     This is an exploratory, open, prospective multi-centre study of VB10.16 immunotherapy in~     patients with high grade HPV16+ Cervical Intraepithelial Neoplasia (HSIL; CIN2/3). This study~     will recruit approximately 27-40 female patients with high grade cervical intraepithelial~     neoplasia (HSIL, CIN 2/3) at multiple sites in Europe.~   "
79226|NCT02529917|"~     Forty physically active men and women aged 18-45y will take part in an 8-week resistance~     training program, randomized (double blind) 1:1 into each of two groups. Twenty participants~     will be randomized to receive 60 g/d of hemp powder (containing approximately 40 g protein~     and 9 g oil) supplementation and 20 randomized to receive 60 g/d of soy supplementation~     (matched to the hemp for macronutrients and calories) during eight weeks of training. Each~     participant will complete testing before and after the intervention for assessment of body~     composition (lean tissue, fat, and bone mass), strength, central fatigue, markers of~     inflammation, and bone resorption. Over the 8-weeks of training, participants will train~     four-five days per week for 1-1.5 hours per session with exercises targeting all major muscle~     groups. The training will involve a two day split where different muscle groups are trained~     on two consecutive days (day 1 involves chest, back, and arms; day 2 legs, shoulders, and~     abdominals). Resistance training will provide the necessary stimulus for protein synthesis to~     optimize the effect of a protein-containing nutritional supplement. The hemp or soy powder~     will be consumed in two doses (i.e. 30 g powder containing 20 g protein per dose) immediately~     after exercise sessions and one hour after exercise. This dosing regimen is optimal for~     stimulating muscle protein synthesis and building muscle mass . On the one non-training day~     per week the two doses will be consumed with meals.~   "
79227|NCT02529904|"~     Influenza infection is related to significant morbidity and mortality in children. The~     trivalent inactive vaccine (TIV) has been documented to have poor immunogenicity in children~     and the live attenuated influenza vaccine (ATIV) although proven to have more efficacy is~     unable to be administered to children under 2 years old. The MF59 adjuvanted influenza~     vaccine as proven efficacy on reducing the rates of laboratory confirmed influenza, including~     in children.~      The study aims to assess early gene transcriptional responses to priming and boosting with~     MF59-ATIV in children aged 13-24 months and adults aged 18 - 65 years, and to establish~     correlations with haemagglutination inhibition (HAI) titers. It will be an open label study~     with 90 healthy children allocated to 3 groups (groups 1, 2 and 3) and 30 healthy adults~     allocated to group 4.~   "
79228|NCT02529891|"~     Exacerbations of the disease are a hallmark of Chronic Obstructive Pulmonary Disease (COPD),~     affecting the decline of pulmonary function, quality of life and increasing morbidity. The~     use of validated biomarkers could help to identify the etiology of exacerbation and to~     prescribe antibiotherapy when indicated.~      The analysis of exhaled air allows measuring different volatile organic compounds (VOC) which~     reflect local or systemic inflammation and oxidative stress. The relationship between the~     presence of some of these compounds and the exacerbation of COPD has never been studied.~      The aim of this study is to identify a cluster of VOC in COPD patients during an acute~     exacerbation of the disease, compared to a stable condition (3 months after discharge).~     Investigators also will seek for a relationship between VOC and the etiology of exacerbation~     (bacterial, viral, inflammatory).~   "
79229|NCT02529878|"~     The prognosis of metastatic gastric cancer is poor. Chemotherapy occasionally converts an~     initially unresectable gastric cancer to a resectable cancer. Previous studies showed~     patients with unresectable gastric cancer may obtain a survival benefit from chemotherapy and~     subsequent curative surgery. The key of conversion therapy of initially unresectable~     metastatic GC is the high response rate. Apatinib, a novel targeted inhibitor of VEGF~     receptor 2 (VEGFR2), shows significant antitumor activity in the patients with GC. The~     purpose of this study is to investigate the efficacy and safety of S1/Paclitaxel chemotherapy~     plus Apatinib in the conversion therapys of metastatic gastric cancer.~   "
79230|NCT02529865|"~     The purpose of this study is to evaluate the efficacy and safety of periurethral injection of~     autologous Adipose Derived Regenerative Cells (ADRCs) in male stress urinary incontinence.~   "
79468|NCT02526771|"~     The aim of this study is to compare the surgical outcomes of conventional lymph node~     dissection with unconventional lymph node dissection during resection of Intrahepatic~     cholangiocarcinoma.~   "
79231|NCT02529852|"~     There are 2 parts to this study: Part 1 (dose de-escalation) and Part 2 (dose expansion).~      The goal of Part 1 of this clinical research study is to find the highest tolerable dose of~     lenalidomide in combination with obinutuzumab and CHOP (cyclophosphamide, doxorubicin,~     vincristine, and prednisone) that can be given to patients with diffuse large B cell~     lymphoma.~      The goal of Part 2 of this clinical research study is learn if the dose of lenalidomide found~     in Part 1 can help to control the disease.~      The safety of this drug combination will be studied in both parts.~   "
79232|NCT02529839|"~     The purpose of this study is to evaluate the safety and efficacy of an immunoablative~     nonmyeloablative conditioning protocol for autologous bone marrow transplantation in patients~     with Multiple Sclerosis. Patients meeting inclusion and exclusion criteria will start an~     immunoablative nonmyeloablative conditioning regimen followed by autologous bone marrow~     transplantation. Patients will be followed for one year by a neurologist to evaluate the~     course of the disease after treatment.~   "
79233|NCT02529826|"~     Due to remarkable advances in cancer treatments, the investigators are witnessing a growing~     population of long-term survivors of childhood malignancies. However, fertility in adult life~     may be severely impaired by gonadotoxic therapies. Since prepubertal boys cannot produce~     spermatozoa, banking of testicular tissue prior to gonadotoxic treatment is a crucial step~     towards fertility preservation for this population. Several centers around the world are now~     cryopreserving testicular tissue for prepubertal boys in anticipation that future~     technologies will allow the utilization of the banked samples for fertility restoration.~      Testicular tissue cryopreservation has now emerged as the leading strategy for fertility~     preservation in prepubertal boys before gonadotoxic treatments. Fertility restoration can~     theoretically be obtained after allo-transplantation of testicular tissue fragments that~     preserve both the SSCs and the supporting microenvironment (spermatogonial stem-cell niche).~   "
79234|NCT02529813|"~     Any time the words you, your, I, or me appear, it is meant to apply to the potential~     participant.~      Sometimes researchers change the DNA (genetic material in cells) of donated T-cells (white~     blood cells that support the immune system) using a process called gene transfer. Gene~     transfer involves drawing blood from the patient, and then separating out the T-cells using a~     machine. Researchers then perform a gene transfer to change the T-cells' DNA, and then inject~     the changed T-cells into the body of the patient.~      The goal of this clinical research study is to find the highest tolerable dose of genetically~     changed T-cells that can be given to patients. Researchers want to learn if these genetically~     changed T-cells may be able to attack cancer cells in patients with advanced B-cell lymphoma~     or leukemia.~      This is an investigational study. The T-cell infusion using a gene transfer procedure is not~     commercially available or FDA approved. At this time, T-cell infusions using a gene transfer~     procedure are only being used in research.~      Up to 30 participants will be enrolled in this study. All will take part at MD Anderson.~   "
79235|NCT02529800|"~     To investigate the PK charateristics and the effect of food on the PK in healthy male~     volunteers who receive HIP1402 capsule in fed versus fasted condition~   "
79236|NCT02529787|"~     Comparative randomized, single dose, two-way crossover open-label study to determine the~     bioequivalence of Dexlansoprazole from Doxirazole 60 mg Capsules (Hikma Pharma,Egypt)and~     Dexilant 60 mg Delayed release Capsules (Takeda Pharmaceuticals America Inc., USA)~   "
79237|NCT02529774|"~     This adaptive seamless Phase II/III trial is to compare the efficacy and safety of adjuvant~     systemic chemotherapy (SCT) with or without hepatic arterial infusion (HAI) after complete~     hepatic resection for Chinese patients with metastatic colorectal cancer.~   "
79238|NCT02529761|"~     This multicenter prospective nonrandomized study is to evaluate the efficacy of TACE combined~     with sorafenib compared with TACE monotherapy in term of overall survival in~     intermediate-stage HCC.~   "
79239|NCT02529748|"~     Dermal transfer efficiency has been defined as the amount of material that moves from one~     surface to another following contact. The investigators propose to measure dermal transfer~     efficiency for the following pathways: (1) object to skin, (2) skin to skin, (3) skin to~     mouth, (4) clothing to skin, (5) gloves to skin, and (6) air to skin. First, the quantitative~     dermal transfer will be measured for the two selected test substances (lead, Tinopal) for~     each of these six pathways. The relative quantities of dermal transfer will also then be~     compared between the different transfer pathways (e.g., is skin to skin transfer greater or~     less than clothing to skin transfer?). And second, the pattern of transfer will be~     characterized semi-quantitatively (e.g., does dermal transfer occur consistently and evenly~     to the skin from different reservoirs?).~   "
79240|NCT02529735|"~     Non-invasive measurement of blood pressure is an instrument governed nursing routine care.~     The use of an automated oscillometric cuff is a common technique and validated if this is~     done on the arm with a suitable cuff, positioned opposite the brachial artery and up to the~     right atrium (the brachial site) . If cons-indication to use the brachial site, measurements~     are frequently performed at the ankle, calf or thigh. Among the blood pressure values~     measured on the 3 sites of the lower limb (thigh, calf or ankle), it may be a specific~     property of which the observed values are closest to the reference values (brachial).~      The objective of this study is to measure the non-invasive blood pressure values at three~     sites of the lower limb, to compare the reference value to determine which alternative site~     should be preferred when the reference measurement is not feasible .~      We want to determine the alternative site to obtain values as close as the measured values of~     the reference site. The three study sites are the thigh, calf and ankle. The reference site~     recommended for monitoring non-invasive blood pressureis the arm.~      It is also assessing the impact of certain parameters on the primary endpoint:~        -  Physiological parameters: gender, weight, height, age, systolic blood pressure~          reference, listed measures.~        -  A parameter related to measurement: discomfort felt when the blood pressure outlet.~        -  Exposure setting: smoking.~   "
79287|NCT02529124|"~     The focus is healthy ageing, i.e. delaying the deterioration in health status in older~     adults. Loss of lean tissue (skeletal muscle) mass, a process termed sarcopenia, or bone~     tissue mass, a process called osteopenia, is a consequence of aging per se, modified by~     nutrition and lifestyle behaviour.~      The aim is to conduct a study of body composition, physical activity, muscle function and~     ability to undertake activities of daily living in older Irish men and women and to~     investigate the effect of a six month period of nutrient support, or nutrient plus physical~     activity on lean tissue mass and function and bone mass in men and women aged 50 to 70 years.~   "
79241|NCT02529722|"~     IgA nephropathy (IgAN) is the most prevalent primary glomerular disease worldwide and an~     important cause of end stage renal disease. IgAN has an incidence of 8-25 new cases/year/per~     million age-related population in adults and 3-5/new cases/year/per million age-related~     population in children and progresses to need of renal replacement treatment in 5-15% at 10~     years and in about 20% at 20 years. The variability of the clinical course anticipates~     different treatment options. There is an absolute need of validated biomarkers to predict~     risk of progression and indication for treatment at early stages, when lesions can be~     reversible. This study aimed to evaluate IgAN progression and its histological and clinical~     correlates.~   "
79242|NCT02529709|"~     The purpose of this study is to see if a high-protein meal leads to a better postprandial~     (after a meal) blood lipid profile compared to a high-monounsaturated meal.~   "
79243|NCT02529696|"~     Maintenance of analgesia during a patient stay in the hospital has been an important area of~     investigation after demonstrating a direct correlation between level of sedation and~     mortality in the ICU setting. This study will investigate the use of accelerometers in~     determining patient sedation level.~   "
79244|NCT02529683|"~     One arm clinical trial of Nuvaring use for six months among 200 previously contracepting~     HIV-negative women (COCPs or DMPA) aged 18-35 in Kenya, where no vaginal rings are~     licensed/available for contraception or other indications. This was meant to be a formative~     research study to understand the predictors of acceptability and adherence to a contraceptive~     vaginal ring, and its immunoogical and microbiological effects over six months of product~     use.~   "
79245|NCT02529670|"~     Chronic axial low back pain is a public health problem and has a high socioeconomic impact.~     The dorsal ganglion of the second spinal nerve (GDL2) is a cluster of neuronal bodies~     responsible for sensory afferent inputs from more than 80% of the lumbar region. Low-level~     laser therapy (LLLT) is proven effective to help relieve pain. Thus, the aim of this project~     is to determine the effect of LLLT on GDL2 when applied to assist in the diagnosis and~     treatment of chronic axial low back pain. Methodology: 45 patients will be randomized into~     three groups: laser, radiofrequency and local anesthetic. The patient will be positioned in a~     prone horizontal position under anesthetic monitoring. The intervertebral foramen between the~     second and third lumbar vertebrae will be accessed by percutaneous puncture guided by~     fluoroscopy. In the local anesthetic group, injection of 1 ml lidocaine without~     vasoconstrictor will be applied in the tubes G20, 150 mm long and 5 mm active tip in contact~     with the target. In the radiofrequency group, neuromodulation will be held for 300 seconds at~     42oC. In the laser group, the laser Photon III® (DCM) will be applied through optic fiber~     crossing G18 cannulas, during 84 seconds. The pain score will be assessed by visual analog~     scale. Temperature will be measured and aspirate periganglionic sample, trans-operatively, to~     study Interleucins-1β and TNF-alpha assessed by ELISA and genetic evaluation trough RNA seek,~     RNA isolation and ATP quantification. The data will be evaluated for normality and subjected~     to appropriate statistical analysis, in order to seek representation, as same as the level of~     significance of the studied samples.~   "
79246|NCT02529657|"~     Each year, more than one million individuals worldwide are submitted to laminectomies, with a~     failure rate higher than 40%. Postlaminectomy epidural adhesion is implicated as a main cause~     of ''failed back surgery syndrome'' and associated with increased risk of complications~     during revision surgery. The postoperative epidural scar can cause extradural compression or~     dural tethering, which results in recurrent radicular pain and physical impairment. Several~     studies in the literature are signalizing that Low-Level-Laser-Therapy (LLLT) is proven to be~     an effective tool to assist the inflammatory process and wound healing, as well to prevent~     infection. Thus, the objectives of this project are to delineate and evaluate the LLLT~     effects in spinal surgery. A prospective randomized, controlled trial with a total of 48~     patients who underwent laminectomy, were divided into 2 groups. In the first group, 25~     patients received LLLT during the surgical procedure over dura mater, over subcutaneous and~     on the skin, as well as 24h and 72h post surgery. In the second group, 23 patients were~     induced to think they will be getting the same treatment, although the laser is not~     operating. In those groups, C reactive protein, Lactate Dehydrogenase and Creatine kinase~     were evaluated in the second and fifth days after surgery, digital temperature will be~     measured and scores in visual analogue scale will be used, 5 minutes pre and 5 minutes post~     Laser application. The drainage output was collected in the first three days following~     surgery in both groups. Interleukins were evaluated in interstitial infiltrate drained in 24h~     and 48h. The data was evaluated for normality and subjected to appropriate statistical~     analysis, in order to seek representation, as same as the level of significance of the~     studied samples.~   "
79247|NCT02529644|"~     The primary aim of this study is to fully test a culturally/religiously-tailored,~     church-based HIV screening intervention (TIPS) against a standard HIV information~     intervention on HIV screening rates at 6 and 12 months with adult African American church~     members and community members who use church outreach services. Our secondary outcome is to~     reduce sexual risk behaviors with this same population.~   "
79248|NCT02529631|"~     This trial compares two treatment methods:~        1. Orlistat 60 mg to be taken three times daily one capsule; indicated for weight loss in~          overweight adults. Important is also that it is taken along with a reduced-calorie and~          low-fat diet.~        2. Polyglucosamine tablets to be taken two times daily two tablets, taken with the two main~          meals with the highest fat content, indicated for weight maintenance and weight loss.~   "
79249|NCT02529618|"~     The purpose of this study is to assess a new screening tool for sideline evaluation of~     concussion injuries in athletes. iDETECT is a new technology that combines several elements~     of recommended concussion screening tools into a single, portable device.~   "
79250|NCT02529605|"~     This is a single dose, randomized, cross-over pharmacokinetic study in healthy volunteers~     (n=12) of two dietary supplement formulations. The Product B® IsaGenesis® formulation~     represents a newer reformulation of an existing product known simply as IsaGenesis®. Beyond~     some changes in the relative abundance of some of the constituents of the earlier IsaGenesis®~     formulation, the Product B® IsaGenesis® product has been formulated as a liquid-gel~     formulation (rather than a dried powder extract) which is theorized to enhance the absorption~     and bioavailability of the contained botanical constituents. The purpose of this study is to~     compare the two dietary supplement formulations relative to the absorption of two compounds~     contained within the supplement known as the flavonolignans silybin A and silybin B into the~     bloodstream after oral administration of capsules.~   "
79251|NCT02529592|"~     The objective of the present study is to specifically assess the effect of lipopolysaccharide~     (LPS) administration on the development of behavioral symptoms and the underlying~     contribution of inflammatory processes. In particular, the investigators will assess the~     development of subjective and objective behavioral symptoms. In addition, the investigators~     will determine whether some psychological trait or state can predict and/or modulate the~     LPS-induced inflammatory and behavioral responses.~      Twenty-five healthy subjects will be included. A placebo-controlled, double-blinded and~     cross-over design will be used. Subjects will receive an intravenous injection of endotoxin~     at 2 nanogram/kilogram (ng/kg) of body weight and an intravenous injection of sodium chloride~     as placebo of endotoxin injection at two different occasions.~      Prior to inclusion and randomization, subjects will come at the hospital and will receive a~     medical examination. Psychological variables that could affect the behavioral (or immune)~     response to LPS will be assessed at that time, using several self-assessment questionnaires.~      On the trial days, injection of endotoxin or sodium chloride will be performed and blood~     samples will be taken just before the endotoxin or sodium chloride injection and 1, 1.5, 2,~     3, 4, 5, 6 and 7.5 hours after the injection. Blood samples will be used to measure several~     inflammatory and immune markers. Urine samples will be taken before the endotoxin or sodium~     chloride injection and as late as possible after the injection. Subjects will wear T-shirt~     all day. Urine and T-shirt samples will be used for behavioral assessment and analysis of~     body odor compound.~      Self-assessment questionnaires assessing behavioral and psychological variables will be~     completed by participants just before the endotoxin or sodium chloride injection, three hours~     and 7.5 hours after the injection. A short questionnaire assessing sickness behavior~     (SicknessQ) will be repeatedly completed by participants from just before to 7.5 hours after~     the endotoxin or sodium chloride injection.~      Several behavioral tests will be used, including a motivation task, a test assessing~     behavioral response to negative and sickness stimuli. Analysis of gait and motion, as well as~     of social interactions, will be performed. Photographs will be taken for the further rating~     of the faces.~   "
79252|NCT02529579|"~     The aim of this study is to evaluate the safety and efficacy of iAPA-DC/CTL combined~     gemcitabine therapy on advanced pancreatic cancer.~   "
79253|NCT02529566|"~     Investigate the potential of tissue grafting that includes human mesenchymal stem cells in~     the repair and potential stabilization of the degenerative Lumbar disk and facet joint denovo~     and at the time of surgical reconstruction. Our hypothesis proposes that stabilization will~     help restore normal structure and function in the degenerative lumbar spine may decrease~     chronic low back pain associated with the biomechanical demise of the degenerative disk or~     facet and may improve the natural history of adjacent segment disease found after spinal~     surgery.~   "
79254|NCT02529553|"~     The main purpose of this study is to evaluate the safety of the study drug known as LY3076226~     in participants with advanced or metastatic cancer.~   "
79255|NCT02529540|"~     Two-month randomized trial comparing three groups.~   "
79256|NCT02529527|"~     Strong evidence supports that preconception care, or care to optimize a woman's health health~     prior to pregnancy, can improve birth outcomes. Preconception health counseling covers a~     broad range of topics, including: desire for pregnancy, obstetric history, nutrition,~     vaccinations, sexual health, chronic disease, substance abuse, mental health and~     contraception. Despite calls from public health organizations and experts in the field for~     universal access to preconception care, most US women do not receive any health counseling to~     prepare for pregnancy. Given that approximately half of US pregnancies are unintended, it is~     critical that routine primary care serve as a venue for the provision of this important~     service. From a patient's perspective, improving preconception health involves many health~     behavior changes. As such, patient engagement and education regarding preconception health~     must be a primary focus. Several preconception health promotion tools have been developed for~     patients to date; few are truly patient-centered and even fewer have been rigorously~     evaluated.~      This study presents MyFamilyPlan - a novel, web-based, patient centered preconception health~     education tool designed for women of reproductive age receiving primary care. MyFamilyPlan is~     truly innovative in two key ways:~        -  MyFamilyPlan is a web-based preconception health self-assessment. This will allow for~          the employment of skip logic to individualize the questionnaire and subsequent health~          recommendations for each patient.~        -  Recognizing that preconception care is relevant to all women at risk of pregnancy,~          MyFamilyPlan has been designed for utilization in a primary care setting.~      This preconception health education tool will be tested using a randomized controlled design.~     This study will measure whether or not exposure to MyFamilyPlan promotes the discussion of~     preconception health issues in primary care encounters (primary outcome). It will also~     evaluate whether the intervention affects participant self-efficacy in planning a healthy~     pregnancy, and relevant health behaviors (secondary outcome). The study proposed here will~     improve the quality of evidence for preconception health education tools. Should it~     demonstrate effectiveness, it will also result in a new tool that could be made more widely~     available to promote preconception health.~   "
79257|NCT02529514|"~     Baclo-Sleep trial aims to investigate the effect of baclofen on sleep after scheduled cardiac~     surgery.~   "
79258|NCT02529501|"~     The purpose of this study is to describe, in real-life conditions, the factors influencing~     the choice of anesthesia (spinal anesthesia or short general anesthesia) in outpatient~     surgery.~   "
79259|NCT02529488|"~     The purpose of this study is to investigate visual outcomes and assess safety at 12 months~     (330-420 days) post bilateral implantation of the AcrySof® IQ PanOptix™ Presbyopia-Correcting~     IOL.~   "
79260|NCT02529475|"~     -  This prospective study aims to better characterize inner ear's perilymphatic structures~          with Magnetic Resonance Imaging using contrast media and delayed injection in healthy~          subjects~        -  MR Perfusion Imaging will be assess in both cochlea as well~        -  Primary auditory brain pathways will be evaluated through MR diffusion imaging~   "
79261|NCT02529462|"~     This study evaluates the efficacy of NEUROPHARMAGEN pharmacogenetic test in the selection of~     the pharmacological treatments for patients with Major Depressive Disorder (MDD), both with~     and without psychiatric comorbidities. Patients will be randomly asigned to test-guided~     treatment prescription or to treatment as usual ina a 1:1 ratio; the results of the test will~     not be disclosed to the later until the end of the 3-month follow-up period. The study will~     compare the rate of treatment responders among both groups, based on patient-reported~     improvement collected by blind telephone interview.~   "
79262|NCT02529449|"~     The objective of this study is to assess pharmacodynamics, pharmacokinetics, and safety of~     ASP1941 in patients with type 1 diabetes mellitus when administered once daily (q.d.) for 2~     weeks.~   "
79263|NCT02529436|"~     Near 40% of French people aged 65 years and over and suffering from Alzheimer disease and~     associated disorders (ADAD) are exposed to antidepressants (AD) versus 13% of those without~     ADAD. If depression and anxiety disorders are comorbidities frequently associated with~     dementia, such level of AD exposure suggests an overuse of AD in this population.~      Hypothesis: Overuse of AD is frequent in patients with ADAD. It is possible to assess overuse~     associated with off label prescriptions (no validated indication and excess in prescription~     duration) Main objective: to assess the prevalence of AD overuse associated with off label~     prescriptions (no validated indication and excess in prescription duration) in patients aged~     70 years and over with ADAD.~      Secondary objectives:~        1. To assess the prevalence of AD prescribed for a non validated indication~        2. To assess the prevalence of AD prescribed with excess in prescription duration~        3. To assess the prevalence of psychotropic coprescription and notably the prevalence of~          the neurologic iatrogenic alerts as defined by the French National Authority for Health~        4. To assess factors associated to AD overuse Method: A transversal monocentric study in~          the geriatric day Bretonneau unit will be performed. Study will be proposed to all~          eligible patients (with non-opposition of the patient or of his legal representative to~          the collection of his personal data). Included people will have no supplementary~          clinical or complementary investigations. The geriatrician in charge will have to~          systematically collect the indication and the history of the AD treatment. At the end of~          the evaluation performed in the geriatric day unit, the geriatrician will have to~          conclude to the AD overuse or not associated with off label prescription. Doubtful case~          will be examined by a validation committee.~      Eligibility criteria: Patient consulting in geriatric day hospital with age ≥70 years and~     dementia according to DSMIV criteria, whatever its level and antidepressant prescription.~      Sample size Considering that 40% of people suffering from ADAD are prescribed antidepressant~     (data from French Health Insurance), the number of eligible patients consulting in the~     geriatric day swill be 65 in 6 months. If 10% of them are opposed to the collection of their~     personal data and if the overuse of AD is near 50%, precision of the result will be 12.8%~     (95%CI bilateral).~      Duration of inclusion: 6 months Duration of patient's participation: one day~   "
82216|NCT02490800|"~     First in human, open-label, sequential dose escalation and expansion study of oral BAL101553~     in adult patients with advanced solid tumors and adult patients with recurrent or progressive~     glioblastoma or high-grade glioma.~   "
79264|NCT02529423|"~     The study examines the feasibility and effectiveness of two different nutritional strategies~     (multi‐nutrient supplement and food‐related behavioural change) to prevent depression in~     high‐risk overweight European Union citizens. Interventions will last 12 months. Design is a~     two‐by‐two factorial randomized controlled prevention trial with four intervention groups:~        1. Control group (daily placebo supplements)~        2. Multi-nutrient supplementation group (daily multi-nutrient supplement)~        3. Food-related behavioural change group (food-related behavioural activation focusing on~          improving overall diet + placebo supplements)~        4. Multi-nutrient supplementation + food-related behavioural activation group (daily~          multi-nutrient supplement + food-related behavioural activation focusing on improving~          overall diet).~      Follow‐up assessment will be conducted at 3, 6, and 12 months for primary and secondary~     endpoints, and during intervention for compliance, adverse events and mediating~     variables.Data will first be analyzed according to the intention‐to‐treat principle, using~     (mixed model) analysis of covariance with primary and secondary endpoints, testing for the~     effects of the two nutritional strategies separately as well as combined.~   "
79265|NCT02529410|"~     100 pt multicentre study 50 pts randomised to triventricular pacemaker, 50 to biventricular~     pacemaker Feasibility study with 6 month outcome data~   "
79266|NCT02529397|"~     This study will examine the effects of providing subjects who have attention deficits, with~     or without a formal diagnosis of attention deficit hyperactivity disorder (ADHD), with~     Working Memory computerized training and explore whether this training is a feasible way to~     help them better engage in a weight loss treatment program, thereby enhancing weight loss~     results. Half of the participants will receive five weeks of online adaptive WM training~     concurrently while attending an in-person 24-week behavioral weight management program and~     half will receive five weeks of a non-adaptive form of cognitive training concurrently while~     attending a 24-week behavioral weight management program in person.~   "
79267|NCT02529384|"~     Breast cancer is the most commonly diagnosed cancer in women and its definite diagnose is~     still challenge for radiologist. This study is going to evaluate multi-b value diffusion~     weighted imaging in discrimination of breast benign and malignant lesions and explore the~     diagnostic effect of the combination of multi-parameter. At the same time, pathological~     specimens of patients will be collected. The relationship between magnetic resonance(MR)~     parameters and pathology biomarkers will be evaluated. Hope multi-b value diffusion weighted~     imaging can improve diagnosis for breast lesion and provide the basis for clinical treatment.~     The fundamental of pathology on MR signal change will be further expounded.~   "
79268|NCT02529371|"~     The study will evaluate device performance and user satisfaction in the UriCap-RM, an FDA~     cleared non-invasive urine collection device for men.~   "
79269|NCT02529358|"~     The study presents findings from a randomized clinical trial evaluating the effects of text~     messages encouraging short emotion regulation exercises on the course of psychopathological~     symptoms after inpatient treatment for depression. In this context, the study also compares~     the effectiveness of standardized versus personalized text messages.~   "
79270|NCT02529345|"~     The objective of this clinical investigation is to evaluate the clinical outcome (up to 12~     months) of treatment by means of stenting with the RoadSaver (Terumo) in subjects at high~     risk for carotid endarterectomy requiring carotid revascularization due to significant~     extra-cranial carotid artery stenosis.~   "
79271|NCT02529332|"~     Omega-3 supplementation has been shown to have neuroprotective and potentially~     anti-inflammatory properties in both central and peripheral nerve injuries. The investigators~     are studying to see if omega-3 supplementation will affect olfactory (smell) function in~     patients with olfactory dysfunction following endoscopic removal of pituitary tumors.~   "
79272|NCT02529319|"~     This proposal is aiming at modifying and improving persistent AF management guidelines by~     evaluating targeting DE-MRI detected atrial fibrosis during AF ablation and its related~     effect on procedural outcome.~      OBJECTIVES:~      Primary Objective: To examine the efficacy of targeting atrial fibrosis tissue during an~     ablation procedure in treating persistent AF. Results from the DECAAF study show that one of~     the most important predictors of ablation outcome was the degree of ablation of the fibrotic~     tissue; the more fibrotic tissue that was overlapped with scar during ablation, the better~     the outcome. These results were the impetus for the primary outcome of DECAAF II. Patients~     will be randomized to receive conventional pulmonary vein isolation (PVI) ablation or PVI +~     fibrosis-guided ablation. The investigators will follow patients longitudinally to assess the~     primary outcome identified as recurrence of persistent atrial arrhythmias (AA) (atrial~     fibrillation, atrial flutter or atrial tachycardia as defined by recent guidelines [2]). The~     investigators hypothesize that patients receiving fibrosis-guided ablation in addition to~     conventional PVI ablation will have fewer AA recurrences than those who receive PVI ablation~     alone.~      The investigators will also examine the efficacy of the fibrosis-guided ablation intervention~     on a number of secondary or exploratory outcomes including the individual components of the~     primary outcome (atrial fibrillation, atrial flutter and atrial tachycardia), symptomatic~     atrial arrhythmia, AF cycle length/regularity/termination, cardiovascular (CV)-related~     hospitalization, CV-related mortality, quality of life measurements (University of Toronto~     Atrial Fibrillation Severity Scale (AFSS), and AF burden.~      The safety of the two interventions will be evaluated by evaluating peri-procedural~     complications including stroke, peripheral vascular stenosis, bleeding, esophageal injury,~     cardiac perforation, heart failure, and death.~   "
79273|NCT02529306|"~     Many type 2 diabetic men have low serum testosterone levels. Our aim in this trial is to~     check if there is a correlation between serum or hair testosteron levels and serum or hair~     cortisol levels in type 2 diabetic men. We'll also examine whether there is a correlation~     between serum and hair testosterone levels and cortisol levels and serum inflammatory~     markers.~      If such correlation will be found- then it is possible that excess cortisol or an abnormal~     inflammatory status- may cause the low testosterone levels that seen in type 2 diabetic men.~   "
79274|NCT02529293|"~     This is a double-blinded, randomised, single-centre phase I pilot trial for exploring the~     feasibility of a pivotal clinical trial establishing bioequivalence between BioChaperone~     insulin lispro U-200 and BioChaperone insulin lispro U-100 in healthy subjects.~      Each subject will be randomly allocated to a sequence of four treatments, i.e. two single~     doses of BioChaperone insulin lispro U-200 of 0.2 U·kg BW-1 and two single doses of~     BioChaperone insulin lispro U-100 of 0.2 U·kg BW-1 on four separate dosing visits.~   "
79288|NCT02529111|"~     The interventional catheterization allows the percutaneous treatment of congenital heart~     diseases as the atrial septal defect (ASD). The examination is guided by the X-rays with~     stochastic side effects worrying at the child's. The software Echonavigator allows to merge~     the ultrasound image and fluoroscopic. This innovative software facilitates the procedures~     and reduce the irradiation time in some adult procedures.~      The aim of this study was to validate the image fusion in children.~   "
79289|NCT02529098|"~     This study will highlight differences in cortical activation between asymptomatic and~     symptomatic patients.~   "
79275|NCT02529280|"~     Increasing Access of Latinas into Breast Cancer Clinical Trials aims to develop and pilot~     test a multi-communications approach - using a culturally relevant computer video, a tailored~     booklet and a patient navigator (PN) - to empower Latinas to make informed decisions about~     breast cancer clinical trials (BCCTs). Latinos represent 15% of the U.S. population but only~     5.6% of participants in National Cancer Institute (NCI) treatment clinical trials, resulting~     in disparities in cancer outcomes and jeopardizing the generalizability of trial findings. In~     response, this study will develop and evaluate communication and health-system-change~     strategies to facilitate Latinas' access to BCCTs at the Cancer Therapy and Research Center~     at The University of Texas Health Science Center at San Antonio (CTRC-UTHSCSA). The~     CTRC-UTHSCSA, an NCI-designated Cancer Center located in South Texas, serves a culturally and~     ethnically diverse population that historically has low participation in clinical trials,~     especially among those with breast cancer, the No. 1 cancer killer of Latinas.~   "
79276|NCT02529267|"~     Intimate partner violence (IPV), also known as domestic abuse, is a leading cause of~     non-fatal injury in women worldwide. 1 in 6 women attending surgical fracture clinics have a~     history of IPV in the past year. Given the high prevalence and costs associated with IPV,~     there is a need to identify health outcomes associated with IPV, the incidence of new and~     worsening cases of IPV, and resource use among IPV victims. This prospective cohort study of~     women with fractures and dislocations will assess differences in injury-related outcomes~     (time to fracture healing, injury-related complications, and return to pre-injury function)~     between abused and non-abused women. This study will also determine whether a musculoskeletal~     injury can lead to new or worsening abuse by an intimate partner and how patterns of IPV~     change over time following musculoskeletal injuries.Finally, the proposed study will also~     inform the feasibility of a larger multinational cohort study.~   "
79277|NCT02529254|"~     The purpose of this study is to determine if video coaching is an efficient way of teaching~     surgical skills outside of the operating room for surgical residents.~   "
79278|NCT02529241|"~     To investigate pharmacokinetics, safety and tolerability of LCB01-0371, LCB01-0371-B after a~     single oral dose in healthy male subjects.~      To investigate safety, tolerability of LCB01-0371 after a single oral dose in healthy male~     subjects.~   "
79279|NCT02529228|"~     This study examines the effect of meal frequency and meal composition on risk factors of~     cardiometabolic disease.~   "
79280|NCT02529215|"~     Communication and teamwork failures are the leading causes of errors in healthcare settings.~     In situ mock code simulations are a potential means to train team-based skills using~     simulation within real clinical care environments where errors occur; however, debriefing~     discussions often focus on gaps in learners' clinical skills as opposed to team functioning.~     This study aims to determine whether learners who are pre-trained using just-in-time~     simulation regarding CPR quality and medication administration will exhibit improved~     performance with respect to these skills during in situ mock codes as well as improved team~     functioning.~   "
79281|NCT02529202|"~     The goal of this proposal is to profile the pharmacokinetics of dexmedetomidine in newborns~     ≥36 weeks post-menstrual age during therapeutic hypothermia for hypoxic-ischemic~     encephalopathy.~   "
79282|NCT02529189|"~     The mainstay treatment for reducing the symptoms of angina and long-term risk of heart~     attacks in patients with heart disease is stent implantation in the diseased coronary artery.~     Whilst this procedure has revolutionised treatment the incidence of secondary events remains~     a concern. These repeat events are due in part to continued enhanced platelet reactivity,~     endothelial dysfunction and a phenomenon called 'restenosis' i.e. the stent becomes blocked~     ultimately requiring another expensive and risky procedure. In this study it will be~     determined whether a once daily inorganic nitrate administration might favourably modulate~     platelet reactivity and endothelial function leading to a decrease in restenosis.~   "
79283|NCT02529176|"~     This is a randomized trial of a best-practice alert delivered via the electronic medical~     record (Apex) to physicians on the Medicine service at UCSF Medical Center over a six month~     period. The alert notifies physicians that their order for continuous cardiac monitoring~     (telemetry) for a given patient has exceeded the duration recommended by national guidelines~     and offers them the opportunity to discontinue monitoring if they feel it is clinically~     appropriate. Physicians will be randomized to either receive the BPA or not, with the~     anticipation that physicians in the intervention arm will discontinue unnecessary telemetry.~   "
79284|NCT02529163|"~     As of late Integrated Care Pathways (ICPs) have been shown to improve quality of care in the~     medical field with special attention given to mental health in particular. One aspect of~     metal health that has not seen the incorporation of ICPs is in the area of schizophrenia.~     Late life Schizophrenia (LLS) is defined as suffering from schizophrenia and being 50 years~     of age or older. The LLS-ICP study will look at the efficacy of an ICP in late life~     schizophrenia versus treatment as usual (TAU). Participants with LLS and having psychotic~     symptoms above a predefined threshold will be randomly assigned to a TAU group or an ICP~     group. The primary outcome measure will be reduction in symptom severity as measured by~     clinical global impression severity scale (CGI-S) and brief psychiatric rating scale (BPRS).~     If successful, this study will provide strong evidence to implement LLS-ICP across different~     inpatient and outpatient settings.~   "
79285|NCT02529150|"~     One in four deaths in the United States is due to cancer, and one in three women will develop~     cancer in her lifetime. Despite improvements in survival among other forms of cancer, ovarian~     cancer prognosis remains poor. Eighty percent of women with ovarian cancer will present with~     advanced disease (stage 3 or 4) where 5-year survival ranges from 18-34%.2 Among patients~     with stage III and IV epithelial ovarian cancer (EOC), recurrence rates are high.4 Therefore,~     interventions focused on preventing recurrence or slowing progression of EOC is a critical~     problem in the field. The investigators have submitted an R21 to NCI for a dose response~     exercise intervention trial to examine the dose response effects of aerobic exercise on~     biomarkers relevant to ovarian cancer progression and recurrence. The reviewers would like~     assurance that the investigators can recruit ovarian cancer patients into an exercise study~     and that these women will do the exercise protocol we plan to prescribe in our high dose of~     exercise.~   "
79286|NCT02529137|"~     The primary objective of this study is to show safety and effectiveness of the PDx for In~     Vitro Diagnostic (IVD) use as an aid to the pathologist to view, review and diagnose digital~     images of surgical pathology slides.~   "
79290|NCT02529085|"~     The present project aims to determine the underlying mechanisms for the switch from failure~     to thrive to excessive weight gain and hyperphagia with impaired satiety in PWS. The primary~     objective is to describe the evolution of circulating hormones involved in feeding and~     appetite regulation during the 4 first years of life. The secondary objective is to make this~     blood bank available for other research projects and particularly the investigation of~     hormones involved in hypogonadism.~      Over the last ten years, the age at diagnosis in PWS has fallen significantly and the~     majority of cases is now diagnosed during the 1st trimester of life giving the possibility to~     collect precise clinical data and serum samples at early stages. The investigators of the~     project are involved in the care of patients with PWS and have a devoted clinic and an~     organized network in their country through clinical networks or patient associations.~   "
79291|NCT02529072|"~     Patients will be randomized to one of two treatment arms - Group I and Group II. Group I will~     receive nivolumab monotherapy until surgical resection, and Group II will receive nivolumab~     alone and with DC vaccine therapy until surgical resection. During surgical resection blood~     and tumor samples will be assessed and compared. Following surgery, both groups will continue~     to receive DC vaccines (total of 8) and nivolumab therapy until confirmed progression.~   "
79292|NCT02529059|"~     This study aims to investigate whether substitution of Efavirenz (EFV) as the~     Tenofovir/Emtricitabine/Efavirenz (TDF/FTC/EFV) fixed-dose combination (FDC) Atripla, with~     Rilpivirine as the tenofovir/emtricitabine/rilpivirine (TDF/FTC/RPV) fixed-dose combination~     (FDC) Eviplera, leads to resolution of covert Central Nervous System (CNS) toxicity~     associated with EFV, continued virological suppression and immunological reconstitution and~     whether this is associated with an improvement in quality of life, sleep, anxiety/depression~     and neurocognitive function; the impact of switch on adherence will also be investigated.~   "
79293|NCT02529046|"~     In this trial, the investigators analyzed the effects of eight weeks of CLA supplementation~     associated with aerobic exercise on body fat and lipid profile in obese women.~   "
79294|NCT02529033|"~     The purpose of this study is to find out the Lidco Rapid ( monitoring tool gives cardiac~     output) is as equivalent in determining the hemodynamic assessment in cardiac surgical~     scenarios as the most often used pulmonary artery catheter, which is much more invasive than~     the Lidco Rapid. This will be accomplished through online surveys which have different~     cardiac surgery scenarios and will be distributed to cardiac fellowship trained~     anesthesiologists. The online based survey will include a specific scenario and details on~     the scenario represented in image format and a brief description of the patient to aid with~     their analysis of the situation.~   "
79295|NCT02529020|"~     The latest findings on the ergogenic effects of a dentistry-design, bite-aligning mouthpiece~     require additional research to assess its impact on anaerobic ability and ventilatory~     parameters. This study was aimed at determining the ergogenic acute effects of wearing a~     custom-made mouthpiece on oral airflow dynamics, Wingate Test performance parameters.~   "
79296|NCT02529007|"~     The study evaluates whether the use of a novel endoscopic cap (the endo-cuff) at the tip of a~     colonoscope improves the numbers of polyps detected during bowel cancer screening~     colonoscopy. Half the patients will have standard colonoscopy and half will have colonoscopy~     with the cap attached.~   "
79297|NCT02528994|"~     This study will test the effect of short-term, high-dose dietary serine supplementation on~     circulating levels of serine. Individuals with risk factors for type 2 diabetes will be~     recruited into the 2 week study. Effects of dietary serine supplementation on glycemic~     measures will also be explored.~   "
79298|NCT02528981|"~     Group B Streptococcus (GBS) is the leading cause of neonatal morbidity and mortality in~     Canada. It may be passed from a study participant colonized in the genital tract by GBS to~     their baby during vaginal birth. While approximately 10 to 30% of pregnant people harbour GBS~     in the vagina or rectum, the incidence of neonatal GBS disease is 1 to 2 infants per 1000~     births. The use of intrapartum antibiotics to treat colonized individuals with or without~     risk factors has led to a 70% decline in the incidence of early-onset GBS sepsis in the past~     decade. Despite this impressive decline, antibiotic resistance has become a major public~     health concern. Association between intrapartum antibiotic use and ampicillin resistance in~     E. coli isolated from neonates has previously been documented. Furthermore, while GBS has~     remained sensitive to penicillin, 20% are resistant to erythromycin and clindamycin, which~     are alternate drugs for patients allergic to penicillin. Alternative approaches are therefore~     needed to reduce the risk of GBS infection.~      We therefore propose to study the use of Lactobacillus rhamnosus GR-1 and Lactobacillus~     reuteri RC-14 (Lactobacillus fermentum RC-14) in the colonization status of GBS in pregnant~     people. Lactobacilli are part of normal gut and vaginal flora and have been widely used as~     probiotics to treat various conditions. In particular, these two strains have shown to be~     beneficial in the treatment of urinary tract infections and bacterial vaginosis. Our study~     design involves recruiting two hundred pregnant people (one hundred in each arm) through~     various midwifery practices in the GTA at the end of their first trimester of pregnancy.~     These individuals will be randomized to receive probiotics or placebo for twelve weeks of~     their pregnancies and will be cultured before delivery to determine their colonization~     status. The capsules with probiotics and placebo will be provided free of charge. The study~     design was chosen to minimize the cost and clients' visits to the clinic as vaginal/rectal~     swabs are routinely offered at 35-37 weeks of gestation.~   "
79299|NCT02528968|"~     Prospective, interventional study of pharmacokinetic (PK)-focused FVIII dosing discussions~     delivered as part of a patient education package.~      The study will capture severe haemophilia A patient reported outcome measures before and~     after PK-focused dosing discussions, including a standardised patient education package, that~     include personalised PK-guided dosing suggestions from a computational predictive device~     (myPKFiT®). The pragmatic study design recognises the CE marked myPKFiT® device is being~     implemented into routine care nationally and consequently only requires a single additional~     clinic visit for the purpose of consenting.~   "
79300|NCT02528955|"~     In patients with squamous cell carcinoma of the oral cavity, the oropharynx and larynx with~     >= pT3 and or pN+ postoperative radio - or radiochemotherapy is the standard of care.~     Postoperative radiochemotherapy is indicated in patients with multiple lymph node metastasis,~     lymph node metastasis with extracapsular spread and or R1/2 resection.~      Locoregional control rates are over 80% after surgery and radio(chemo)therapy. But many~     patients suffer from therapy-related long-term side-effects, like xerostomia, dysphagia,~     fibrosis, trismus etc.~      The aim of this study is to investigate if depending on primary tumor stage, quality of~     resection ( resection margin) and number of lymph node metastasis and performed neck~     dissection an adapted de-intensified dose- and target volume concept may be performed without~     reducing locoregional-control but with reducing radiotherapy-related side-effects.~   "
90970|NCT02376439|"~     This research studies the energy balance behaviors (usual eating, physical activity,~     sedentary) and non-shared experiences of siblings discordant for weight (one sibling is lean~     the other is overweight).~   "
79305|NCT02528890|"~     The incidence of early neonatal GBS (group B Streptococcus) infection in the Nazareth~     Hospital through the years 2006-2013 has been higher compared to the national average. On~     reviewing all the cases of infants with early GBS infection, revealed that some of these~     infants were born to mothers who are not included in any of the high-risk groups that need to~     have prophylactic antibiotic treatment before delivery. Therefore, the question was whether~     pregnant Arab women in the North district of Israel have a higher GBS carrier state rate than~     the general rate in Israel?~   "
79306|NCT02528877|"~     This phase I trial studies the side effects and best dose of ruxolitinib phosphate when given~     together with tacrolimus and sirolimus in preventing acute graft-versus-host disease during~     reduced intensity donor hematopoietic cell transplant in patients with myelofibrosis.~     Sometimes transplanted cells from a donor can attack the normal tissue of the transplant~     patient called graft-versus-host disease. Ruxolitinib phosphate may stop the growth of cancer~     cells by blocking some of the enzymes needed for cell growth. It may also reduce~     graft-versus-host disease by reducing inflammation and immune modulation. Giving ruxolitinib~     phosphate together with tacrolimus and sirolimus after transplant may prevent~     graft-versus-host disease.~   "
79307|NCT02528864|"~     The aims of this project are: (1) To establish a research platform in order to integrate~     multiparametric imaging and metabolomics data for uterine malignancy. (2) Identify potential~     surrogate biomarkers for early diagnosis of endometrial cancer by using multiparametric~     magnetic resonance imaging and metabolomics approach. (3) To develop surrogate biomarkers for~     uterine malignancy, in detecting tumor involvement of myometrium, cervix, and lymph nodes.~     The investigators propose a 3-year research project to prospectively collect data from 150~     female patients 20-80 years old, with clinically diagnosed or suspected to have uterine~     malignancy. An additional control group comprising 30 patients with normal endometrial tissue~     will be enrolled. Robust magnetic resonance (MR) imaging techniques including MR spectroscopy~     (MRS), diffusion-weighted imaging and chemical exchange saturation transfer (CEST) imaging~     will be applied. Biological samples (tissue, blood, urine) will be analyzed by detailed~     metabolomics approach (high-resolution MRS).~   "
79308|NCT02528851|"~     The aim of this study is to compare the cardiovascular and respiratory effects of higher~     versus equivalent CPAP pressures post-extubation from high endotracheal airway pressures~     (EAP), defined as at least 8 cm H2O (water), in the form of a randomized controlled~     cross-over trial. Endotracheal airway pressure (EAP) will be defined as mean airway pressure~     (MAP) [if on high frequency ventilation] or positive end-expiratory pressure (PEEP) [if on~     conventional ventilation] at time of extubation. Participants will be randomized to higher~     CPAP group (CPAP level 2cm H2O higher than the extubation EAP) or equivalent CPAP group~     (CPAP level equal to the extubation EAP) before undergoing crossover to the other arm. We~     hypothesize that higher CPAP levels, when compared to equivalent CPAP levels, do not~     adversely impact the cardiorespiratory status when a patient is extubated from high EAP.~   "
79309|NCT02528838|"~     The study is designed as a prospective, non-interventional, observational single arm study.~     Hundred-fifty patients over 18 with stable disease or at least partial response while on~     treatment with lenalidomide will be recruited from approximately 20 haematology/oncology~     sites in the Netherlands. Recruitment will continue until 150 patients have started the~     study. When this target is reached, all patients on lenalidomide will continue to be followed~     until the last patient has been followed for 36 months.~   "
79310|NCT02528825|"~     Smooth emergence is important for patient safety and satisfaction. Coughing during emergence~     is associated with detrimental effects like laryngospasm, sore throat, hoarseness, negative~     pressure pulmonary edema and bleeding at surgical site 1. Especially sore throat and~     hoarseness are most common complications after extubation 2,3 and closely related to patient~     satisfaction 4. Using double lumen tube (DLT) increase the incidence of hoarseness and airway~     injury than using single lumen tube for it has large size5,6. Various technique and drugs~     have been proposed for reducing coughing during extubation including smooth emergence 1,7-11~     and this is closely correlate with reducing sore throat and hoarseness 12. One of the~     proposed technique, the use of short acting opioids are prefered13-15 because it can be~     maintained during emergence with less respiratory depression. Remifentanil is a potent short~     acting opioid and several studies choose remifentanil combined with other anesthetic agents~     1,15,16. There is a study about the EC50 and EC95 of remifentanil in effect site Target~     controlled infusion(TCI) for preventing cough during emergence after thyroidectomy with~     propofol-remifentanil anesthesia 15 but no study about the proper dose of remifentanil for~     smooth DLT extubation.~      The purpose of this study was to evaluate the EC50 and EC95 of remifentanil in effect-site~     TCI for preventing cough during extubation of DLT in total TIVA with propofol and~     remifentanil.~   "
79311|NCT02528812|"~     In a randomized control trial and single blinded study, tender spots were identified in 150~     participants` plantar flexor muscles (gastrocnemius or soleus). Then participants were~     randomly assigned to one of five intervention groups (n = 30): 1) heavy rolling massage on~     the calf that exhibited the higher tenderness (Ipsi-R), 2) heavy rolling massage on the~     contralateral calf (Contra-R), 3) light stroking of the skin with roller massager on the calf~     that exhibited the higher tenderness (Sham), 4) manual massage on the calf that exhibited the~     higher tenderness (Ipsi-M) and 5) no intervention (Control). Pain pressure threshold (PPT)~     was measured at 30 seconds and up to 15 minutes post-intervention via a pressure algometer.~   "
79312|NCT02528799|"~     A randomized, double-blind, placebo-controlled, dose titration trial, stratified by Human~     Leukocyte Antigen (HLA)-DQ2.5 genotype in subjects with celiac disease.~   "
79313|NCT02528786|"~     The purpose of this study is to obtain blood samples from up to 14 participants who~     previously received namilumab in the previous study M1-1188-002-EM (PRIORA, [NCT01317797]) to~     correlate genetic markers with clinical outcomes.~   "
79337|NCT02528474|"~     Drug-coated balloon technology (DCB) has recently attracted considerable interest as a~     promising alternative treatment option, particularly in the setting of in-stent restenosis~     (ISR). Optical coherence tomographic finding of restenosis lesions in drug-eluting stents~     (DESs) after Balloon Angioplasty with Two Different Paclitaxel-Coated Balloons will be~     compared between two paclitaxel-coated balloon devices; Pantera Lux™ and SeQuent® Please.~   "
90971|NCT02376426|"~     The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and~     Ad26.ZEBOV administered as heterologous prime-boost vaccine regimens in healthy adult~     participants.~   "
79314|NCT02528773|"~     The investigators are conducting a study to learn more about the spread of HIV infection~     within different geographic regions and populations in San Diego County, with the goal of~     demonstrating that early use of HIV treatment can reduce the number of new infections in our~     community. At the study visits, participants will be examined by the study staff and asked to~     donate some blood. Participants will also be asked several questions about themselves, their~     background, behaviors, health, and the general geographic area in which they live. By~     collecting information about antiretroviral treatment choices that are made by study~     participants, the investigators will be better able to measure how effectively HIV treatment~     can interrupt (i.e., block) the spread of HIV. All of the information gathered at the study~     visits will be de-identified and analyzed. Study staff will use the information to better~     understand in which groups of people, and in what areas of San Diego, HIV is spreading most~     quickly. This information will be used to determine how well Antiretroviral Therapy (HIV~     treatment) by certain individuals can control the spread of HIV within the population.~   "
79315|NCT02528760|"~     1. All patients with chronic liver disease admitted in ICU (Intensive Care Unit) to be~          screened.~        2. Patients fulfilling criteria for feed intolerance to be included in the study.~        3. Patients to undergo routine biochemical and hematological testing including CBC, KFT,~          LFT, PT/INR, electrolytes baseline and daily along with ABG (Arterial Blood gas)~          analysis.~        4. Patients with ascites to be tested for presence or absence of SBP (Spontaneous Bacterial~          Peritonitis).~        5. Cultures to be sent as based on clinical parameter of the patient.~        6. All correctable causes for intra abdominal hypertension to be corrected including~          electrolyte imbalance, grade III ascites, intra abdominal infection.~        7. Symptoms- Absent bowel sounds (BS)= no BS detected by auscultation.~          Vomiting/regurgitation= any visible regurgitation of gastric contents; Diarrhoea= liquid~          stool > or =3 times/day; Bowel distension= suspected clinically and radiologically~          confirmed; Large gastric residual volume (GRV) of >or =500 ml/24 h on a single day or >~          200ml at any time of the day.~        8. Per abdomen findings to be checked daily including presence of bowel sounds, tenderness,~          development of abdominal distension, abdominal girth monitoring and abdominal pressure~          monitoring.~        9. Patients who develop feed intolerance will be included.~       10. Feed intolerance to be defined as per study definition (3 out of 5 symptoms).~       11. Measurement of GRV (Gastric residual volume) to be done at 4 hourly interval.~       12. Methods for measuring GRV by either gravity drainage by connecting a gastric tube to a~          drainage bag for 10min or by manual aspiration of content using a 50ml syringe.~       13. Once feed intolerance develop than every 6 hourly intra abdominal pressure monitoring~          and abdominal girth monitoring to be done (24)~       14. Intra bladder pressure to be measured using Foleys manometer technique (25).~       15. Pressure measured in cm of water to be converted into mm of Hg.~       16. X ray abdomen supine to look for bowel distension, defined as more than 3 cm for small~          bowel and more than 5 cm in large bowel.~       17. Development of intra abdominal hypertension based on intra abdominal pressure.~       18. Patient to be stratified according to the grade of intra-abdominal hypertension.~       19. After correction of all correctable causes, if feed intolerance persists, then patient~          to be randomized by block randomization method into 3 arms, metaclopromide group,~          erythromycin group or placebo group.~       20. Daily assessment of bowel sounds, abdominal pressure, abdominal girth every 6 hourly and~          gastric residual volume to be noted every 4 hourly.~       21. Response of therapy to be assessed at 24 hours in each arm.~       22. Response to be assessed by resolution of feed intolerance or initiation of entral~          nutrition.~       23. Metoclopromide to be given 10mg iv 8 hourly.~       24. Erythromycin to be given 70mg iv 12 hourly (26).~       25. Placebo arm to receive normal saline in 10ml syring twice daily.~       26. After 24 hours of treatment if symptoms do not resolve than rescue treatment will be~          given to each arm which may include continuation of prokinetics, add on prokinetic,~          flatus tube insertion for bowel decompression, upgradation of antibiotics or search for~          any other cause, as per the patient response.~       27. Therapy to continue for a total duration of 72 hours.~       28. If there is no response at 72 hours, than study stops.~       29. If patient responds to given treatment, study to continue for a total duration of 7~          days.~       30. Assessment to continue in each arm for a maximum period of 7 days.~   "
79316|NCT02528747|"~     This observational, multicenter survey is designed to assess the efficacy of oral ibandronate~     in adults with breast cancer and metastatic bone disease. Data on the use of ibandronate in~     clinical practice will be collected from Hungarian patients.~   "
79317|NCT02528734|"~     Monocentric observational study of needle exsufflation for pneumothorax in the ICU.~   "
79318|NCT02528721|"~     The Exalenz Dual Mode BreathID® Hp System comprised of IDkit: Hp™ TWO and the Dual Mode~     BreathID® Hp test device will be used to perform a urea breath test in the initial diagnosis~     and post treatment monitoring of H.pylori infection in adult patients and its results will be~     compared to biopsy results.~   "
79319|NCT02528708|"~     In this prospective, single-center, randomized, placebo-controlled, double-blind clinical~     trial, parturients with primary PPH are eligible for treatment with fibrinogen concentrate~     following both vaginal delivery and cesarean section complicated by an estimated blood loss~     (EBL) >1000 mL and an ongoing bleeding notwithstanding standard treatment measures (volume~     replacement, uterine massage, and uterotonic agents).~   "
79320|NCT02528695|"~     The metabolic function of different white adipose tissue depots in the body and its role in~     the development of type 2 diabetes (T2D) remains unclear. Several studies have used fluor-18~     fluorodeoxyglucose positron emission tomography with computed tomography (FDG PET/CT) to~     image the metabolic activity of different adipose tissues in lean and obese healthy subjects~     and in patients with T2D with or without euglycaemic hyperinsulinemic clamping, describing~     differences in metabolic activity of visceral adipose tissue (VAT), subcutaneous adipose~     tissue (SAT) and gluteal-femoral adipose tissue (GFAT). Recently, FDG PET/CT showed high~     glucose uptake in VAT and SAT under unintentional hypoglycaemic conditions in a non-diabetic~     patient. Evaluation of potential differences in FDG uptake in white adipose tissue between~     healthy volunteers and T2D patients and between VAT, SAT and GFAT in these subjects under~     hyperinsulinemic hypoglycaemic conditions would be of great value in further exploring the~     pathogenesis of insulin resistance in T2D.~   "
79321|NCT02528682|"~     Allogeneic stem cell transplantation (allo-SCT) is a potent treatment, and sometimes the only~     curative treatment for aggressive hematological malignancies. The therapeutic efficacy is~     attributed to the graft-versus-tumor (GVT) response, during which donor-derived CD8+ T cells~     become activated by recipient minor histocompatibility antigens (MiHA) presented on dendritic~     cells (DC). Consequently, these alloreactive donor T cells clonally expand, acquire effector~     functions and kill MiHA-positive malignant cells. However, in a substantial number of~     patients persistence and recurrence of malignant disease is observed, indicating that~     insufficient GVT immunity is induced. This is reflected by our observation that not all~     patients develop a productive CD8+ T cell response towards MiHA mismatched between the~     recipient and donor. We found that the PD-1/PD-L1 co-inhibitory pathway is involved in~     dampening MiHA-specific CD8+ T cell expansion and function post-transplantation. Therefore, a~     promising strategy to induce or boost GVT immune responses is pre-emptive or therapeutic~     vaccination with ex vivo-generated donor DCs loaded with MiHA that are exclusively expressed~     by recipient hematopoietic cells and their malignant counterparts. In contrast to pre-emptive~     donor lymphocyte infusion (DLI) with polyclonal donor T cells, this MiHA-DC vaccination~     approach has less risk of inducing graft-versus-host disease (GVHD) and the potency to induce~     more efficient GVT-associated T cell immunity. In addition, the potency of this DC vaccine~     will be further enhanced by interference with the PD-1/PD-L1 co-inhibitory pathway, using~     siRNA mediated PD-L1/PD-L2 silencing.~   "
79322|NCT02528669|"~     The purpose of this study is to create a platform that accurately measures and reports~     patient physical activity before a procedure, during the hospital stay, and after discharge~     from the hospital.~   "
79323|NCT02528656|"~     The physiological assessment in non-operative treatment on chest wall deformities, are still~     unclear today. These functional benefits outweigh the aesthetic benefits associated with~     anatomical improvement. The functional benefits, ventilation, hemodynamic and neurologic,~     have never been evaluated.~      Assessment of Effects on parasympathetic activity of the autonomic nervous system, global~     health criterion measured by noninvasive methods.~      Anatomic evaluation, between the initial and final assessment by objective measures 1) of the~     chest wall by MRI, and 2) of the heart by echocardiography.~      Noninvasive physiological assessment at rest and during exercise in respiratory function~     exploration flows and volumes, cardiac function by flow measurement, and overall metabolic~     function test effort (VO2max). Subjective assessment of functional gain between the initial~     and final balance sheet, based on EVA scales, valued by patients, parents and doctors.~   "
79324|NCT02528643|"~     The purpose of the study is to evaluate the efficacy of enzalutamide in subjects with~     advanced hepatocellular carcinoma (HCC) as measured by overall survival (OS).~      This study will also evaluate the safety of enzalutamide; pharmacokinetics of enzalutamide~     and the active metabolite N-desmethyl and Progression Free Survival (PFS) of enzalutamide as~     compared to placebo in subjects with advanced HCC.~   "
79370|NCT02528045|"~     The medical records of 16 eyes of 16 patients with macular hole retinal detachment or myopic~     traction maculopathy who received viterctomy including internal limiting membrane peeling and~     scleral shorting surgery were reviewed. Best-corrected visual acuity, axial length, retinal~     reattachment and macular hole closure, the shape of staphyloma determined by optical~     coherence tomography and 3-dimensional magnetic resonance imaging were assessed.~   "
79325|NCT02528630|"~     Background: Hand osteoarthritis (OA) is highly prevalent, affecting 55-70% of the population~     over 55 years with an age-related progressive increase. The OA of interphalangeal (IF) and~     carpometacarpal joints may have varying degrees of deformity associated with pain, decreased~     of grip and pinch strength, decreased range of motion and functional impairment. Systematic~     reviews and meta-analyzes have shown the beneficial effect of exercise for lower limb OA,~     however for hand OA exercise is still used based on recommendations based on clinical~     experience and low quality studies, not allowing a conclusion about the effects of exercise~     in pain, function and strength in hand OA patients.~      Objective: assess the effectiveness of progressive resistance strength training program on~     pain, function and strength in hand OA patients.~      Methods: diagnostic of hand OA according to American College of Rheumatology of at least~     1year, age over 50 years, both genders, pain in IF joints between 3-8 cm on a 10-cm numerical~     pain scale (NPS). Sixty patients who meet the eligibility criteria were randomized into~     exercise group (EG) and control group (CG). Both groups performed a session regarding joint~     protection and energy conservation before randomization. The EG performed a progressive~     resistance strength training program for intrinsic muscles of the hand for 12 weeks. The~     outcome measures were NPS; Australian/Canadian (AUSCAN) Hand Osteoarthritis Index and Cochin~     Hand Functional Scale for hand function; grip and pinch strengthening using the Hydraulic~     Hand Dynamometer and a pinch gauge dynamometer and satisfaction with the treatment using a~     Likert scale. A blinded evaluator performed the evaluations at baseline, 6 and 12 weeks after~     treatment baseline.~   "
79326|NCT02528617|"~     The purpose of this trial is to study the effect of Velaglucerase Alfa on skeletal bone~     development of children with Type 1 or Type 3 Gaucher Disease. In addition, the natural~     history and neurological status of children with Type 3 Gaucher Disease will be studied.~   "
79327|NCT02528604|"~     Comparison of (i) catheter ablation, (ii) electrical cardioversion and (iii) pacemaker~     implantation with AV node ablation for patients over 65 years of age with persistent Atrial~     Fibrillation.~   "
79328|NCT02528591|"~     The renal transplant patient is at high cardiovascular risk compared to the general~     population. The cardiovascular mortality represents one of the most important causes of late~     graft loss. Cardiovascular risk prediction tools applied to the general population, however,~     are caught failing on the population of kidney transplant and tend to underestimate the~     actual risk.~      Central blood pressure is the pressure imposed at large artery (aorta, carotid) and is~     directly related to the target organ (heart, kidney, brain). Central blood pressure could be~     a cardiovascular risk factor more robust and powerful than brachial blood pressure.~      Central blood pressure may in part explain the increased risk of cardiovascular disease in~     the population of kidney transplant patients. A cohort of 250 kidney transplant patients will~     be constituted with a measure of concomitant central hemodynamic monitoring to the annual~     review will be conducted. The main objective of this study is to describe the central blood~     pressure measured by oscillometric method in renal transplanted population.~   "
79329|NCT02528578|"~     The objective of the study is to evaluate in healthy volunteers, the influence of empathy on~     pain perception.~      It is widely accepted in the clinical management that the feeling of listening to the~     patients' pain would have a favorable influence on the pain, and conversely, the lack of~     listening would be aggravating.~      In this study, the volunteer will receive painful thermal stimuli in empathetic context (l,~     empathetic or non-empathetic) Two situations will oppose, one where the examiner neglect or~     minimize the suffering of the voluntary and the other or the contrary, the subject will~     receive empathy.~      The first part of the project is to verify that the pain is influenced by the empathetic~     context. The second part will be conducted functional MRI, which should isolate the brain~     regions affected by other people's empathy for pain.~   "
79330|NCT02528565|"~     The safety and efficacy of the Adhesix Bioring adjustable gastric band will be assessed in~     patients after failed RYGB.~   "
79331|NCT02528552|"~     This is a prospective, randomized double-blind, multi-center study to evaluate the efficacy~     of low level laser therapy over-the-counter at home device Theradome LH80 PRO, compared to~     SHAM for promoting hair growth in males diagnosed with androgenetic alopecia, and a usability~     study to assess subject ability to self-assess hair loss and understanding use of the device.~   "
79332|NCT02528539|"~     Introduction: Breast cancer women who are treated with axillary node dissection are at~     increased risk for lymphedema - the lifetime risk in these women is estimated at 15-50% and~     the risk can significantly increase with chemotherapy and radiation therapy~      Objectives:~        1. To evaluate the feasibility and effectiveness of implementing the integrative therapy~          program (ITP) intervention. ITP consists of self-management education in conjunction~          with acupuncture.~        2. To determine if ITP affects quality of life, self-efficacy, lymphedema knowledge, pain,~          and early detection and management of lymphedema.~      Design: the exploratory study aims to evaluate the feasibility and benefits of the~     integrative therapy program (ITP) intervention post-operatively for 18 months.~      Subjects: Women with breast cancer treated with axillary node dissection with normal baseline~     pre-operative bioimpedance (L-dex U400) score.~      Sample size: 30 subjects~   "
79333|NCT02528526|"~     The purpose of the study is to evaluate whether the novel anti-cancer drug OXY111A is safe~     and tolerated in patients with primary and secondary hepato-pancreato-biliary and~     gastrointestinal neoplasia as measured by exploring the maximum tolerated dose (MTD). At~     level of MTD, additional patients will be included aimed for assessing the efficacy profile~     in these neoplasia entities.~   "
79334|NCT02528513|"~     The purpose of this study was to evaluate effects, safety and cost of midazolam used alone or~     sequential use of midazolam and propofol/dexmedetomidine for long-term sedation in critically~     ill, mechanically ventilated patients.~   "
79335|NCT02528500|"~     This study will assess the initial feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch~     Endoprosthesis (TAMBE Device) in the treatment of Aortic Aneurysms Involving the Visceral~     Branch Vessels.~   "
79336|NCT02528487|"~     The present study aims to assess the prevalence and impact of comorbid psychiatric disorders~     among patients with chronic obstructive pulmonary disease (COPD) undergoing pulmonary~     rehabilitation (PR), in order to determine the effects of psychiatric comorbidity on exercise~     tolerance and physical activity post-PR and HRQoL, as well as to determine the processes by~     which these psychiatric disorders may impact on these patient behaviours.~   "
79338|NCT02528461|"~     The purpose of the study is to investigate how the liver is affected with regard to~     inflammation and fibrosis during Sofosbuvir based treatment regimes of chronic hepatitis C.~      In order to examine how the liver heals, we want to use blood samples to check for the~     occurrence of special liver inflammation cells (CD163 and CD206). To assess to which extent~     fibrosis disappear during treatment, we want to examine the liver with FibroScan (a type of~     ultrasound examination) and also preferably with extraction of a small tissue sample. We want~     to examine how the liver function as inflammation and scar tissue decrease, especially~     concerning the liver's ability to produce proteins. Furthermore, we want to examine with a~     gastroscopy, if the circulation of blood in the liver is improved after successful treatment~     with the expected result that potential varicose veins in the esophagus vanish.~   "
79339|NCT02528448|"~     The purpose of this study is to determine if chloride is nephrotoxic using 0,9% saline versus~     Plasma-Lytein in patients having primary hip replacement surgery. The outcome is found~     measuring bio markers, vasoactive hormones and salt regulation. And to measure syndecan as a~     marker for glycocalyx degradation.~   "
79340|NCT02528435|"~     Methotrexate is a cornerstone in the treatment of childhood leukemia. When given in high-dose~     as part of the initial phase of treatment, gastrointestinal toxicity is a known problem.~     However when children reach maintenance treatment with low-dose methotrexate this is not~     described as a significant challenge. Children with juvenile idiopathic arthritis are another~     patient group receiving low-dose methotrexate. Among these patients gastrointestinal~     intolerance is such a significant problem that treatment may be ceased. The aim of this~     project is to create a greater understanding of gastrointestinal intolerance associated to~     low-dose methotrexate treatment by investigating the differences between these two patient~     groups, investigating genetic and psychological factors.~   "
79341|NCT02528422|"~     Ghrelin (growth hormone release inducer) is produced in the stomach. The active form of~     Ghrelin is Acyl-Ghrelin. Acyl-Ghrelin stimulates the Ghrelin receptors. Ghrelin receptors are~     detected in the distal tubules in mice and animal studies have shown that Ghrelin increases~     the absorption of sodium in the renal tubules. Ghrelin infusion directly into the renal~     artery of rats increased sodium reabsorption in the distal nephron, presumably via the~     epithelial sodium channels (ENaC).~      The purpose of the study is to measure the acyl-ghrelin induced effects on GFR, tubular~     transport of sodium and water in different nephron segments and central and peripheral blood~     pressure in a randomized, cross-over, single-blind, placebo-controlled dose-response study.~   "
79342|NCT02528409|"~     The aim of the present study is to examine the efficacy and safety of vortioxetine vs placebo~     in adults with moderate to severe Binge eating disorder, as indicated by at least 3 binge~     eating days per week for the 2 weeks before the baseline visit.~   "
79343|NCT02528396|"~     This is a double-blind, randomised, controlled, two period crossover phase Ib trial using an~     individualized standard meal with a fixed nutrient ratio in subjects with type 1 diabetes~     mellitus to investigate postprandial blood glucose control with BioChaperone insulin lispro~     compared to Humalog®. The assessments will be conducted before and after a period of multiple~     daily dose administrations for 14 days. The meal tolerance test will be performed on day 1-3~     and on day 14 of each period. Furthermore the study aims at investigating Post-prandial~     glucose (PPG) profiles with BioChaperone insulin lispro and Humalog® when injected at various~     injection meal intervals (-15min, 0 minutes, +15 minutes).~      Each subject will be randomised to a sequence of two treatments, either BioChaperone insulin~     lispro-Humalog® or Humalog®-Biochaperone insulin lispro, and three different sequences of~     injection-meal intervals. A blinded to patient continuous monitoring of glucose (CGM) will be~     performed during the 14 day treatment periods.~   "
79344|NCT02528383|"~     Vagifem, is the most appropriate medication to treat bladder and vaginal symptoms such as~     vaginal dryness and urinary discomfort. The purpose of this research study is to see the~     benefit this three month vaginal estrogen tablet, Vagifem, has on the bladder, vaginal~     symptoms and health. The investigators also want to monitor whether the bones might be~     impacted by estrogen or its absence. If there is an effect on bones, it means that some~     estrogen may be absorbed from the tablet to affect other places in the body. The~     investigators are hoping to prove this is not the case. The investigators will also be~     measuring the quality of life of women participating in the study.~   "
79345|NCT02528370|"~     Observational non-randomized study with an intervention cohort from Hospital~     Galdakao-Usansolo with 119 patients and a control cohort from Hospital Cruces with 78~     patients. The inclusion criteria were: being hospital admitted at least twice in the previous~     year or at least three times in the 2 previous years. The cohorts were follow-up for 2 years.~     Several clinical measurements like pulmonary function, exercise capacity, health related~     quality of life, limitation in daily life activities and anxiety and depression were recorded~     in both cohorts. Telemonitoring and an organized education program were only and exclusively~     applied in the intervention cohort.~   "
79346|NCT02528357|"~     This is a first time in human (FTIH), open-label, non-randomized, multicenter study designed~     to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and~     preliminary clinical activity of GSK3174998 administered intravenously to subjects with~     selected advanced or recurrent solid tumors.~      This dose-escalation study will assess the safety, activity of GSK3174998 as monotherapy~     (Part 1), in combination with pembrolizumab (Part 2), and potentially in combination with~     additional therapies.~      The study will be conducted in 2 parts, each part consisting of a dose-escalation phase~     followed by a cohort expansion phase. Part 1 will evaluate GSK3174998 monotherapy, while Part~     2 will evaluate GSK3174998 in combination with pembrolizumab.~      GSK3174998 will first be evaluated as monotherapy in escalating doses. Once a dose of~     GSK3174998 has been identified that is both tolerable and demonstrates pharmacodynamic~     activity, enrollment of Part 2 may begin. In Part 2, escalating doses of GSK3174998 will be~     evaluated with fixed doses of pembrolizumab.~      The study will enroll up to approximately 264 subjects with different tumor types~     (approximately 144 subjects in Parts 1A and 2A [dose escalation]; approximately 120 subjects~     in Parts 1B and 2B [cohort expansion]). The maximum duration of treatment with GSK3174998~     plus or minus pembrolizumab will be 2 years or 35 cycles, whichever comes first. The~     follow-up period for safety assessments will be a minimum of 3 months from the date of the~     last dose. The post-treatment follow-up period includes disease assessments every 12 weeks.~   "
79347|NCT02528344|"~     The overall objective is to determine whether High Intensity Interval Training (HIIT) has~     potential to improve disease activity scores for Rheumatoid Arthritis (RA) patients. By~     reducing inflammation and modifying immune function HIIT may offer a substantial paradigm~     shift in RA care, especially in older persons with RA who experience aging~     related-immunesenescence, increased systemic inflammation and greater physical inactivity~     than young persons. Prior to embarking on a large scale trial of HIIT-induced disease~     modification, this pilot study aims to demonstrate that HIIT can produce measurable responses~     in disease activity scores and peak VO2in persons undergoing routine pharmacologic treatment~     for RA.~   "
79348|NCT02528331|"~     The purpose of this study is to evaluate the effectiveness of repetitive TMS (rTMS) delivered~     simultaneously with elements of cognitive behavioral therapy/exposure-response prevention~     (CBT/ERP) in adult subjects (greater or equal to 18 years old) with obsessive-compulsive~     disorder (OCD). This is an open label study that involves standard of care for OCD (CBT) and~     an investigational treatment modality (TMS). The investigators will compare the Yale-Brown~     Obsessive Compulsive Scale (YBOCS) scores before and after treatment to quantify clinical~     improvement. The side effects from TMS include, but are not limited to, headache, seizure,~     and general pain. CBT has minimal side effects other than mental discomfort during the~     exposure sessions. For safety concerns, pregnant women and subjects with seizure-related~     history will be excluded as well as other indicated conditions in the details protocol.~   "
79349|NCT02528318|"~     The primary objective of this study is to evaluate the safety and tolerability of lucinactant~     for inhalation, administered as an aerosolized dose in up to four escalating doses to preterm~     neonates 26 to 28 weeks gestational age who are receiving nasal continuous positive airway~     pressure (nCPAP) for respiratory distress syndrome (RDS) compared to neonates receiving nCPAP~     alone.~   "
79350|NCT02528305|"~     This pilot study aims to investigate whether 6 weeks of twice weekly High-intensity Interval~     Training (HIT) results in improvements in disease-specific measures, feelings of general~     well-being, physical fitness and cognitive function in patients with non-alcoholic fatty~     liver disease or non-alcoholic steatohepatitis.~   "
79351|NCT02528292|"~     This study will be an open label observational prospective study assessing the clinical~     efficacy of antiTNFα therapy and the alteration/impact on the synovial tissue, with specific~     regard to lymphoid aggregation, over a period of 12 months in patients with rheumatoid~     arthritis.~      Rheumatoid arthritis (RA) is one of the most important chronic inflammatory disorders in the~     UK. It affects approximately 1% of adults and causes considerable morbidity, substantially~     reduces quality of life and has a significant mortality. It results in large direct medical~     costs as well as extensive indirect social costs. Despite the significant therapeutic~     progress following the introduction of antiTNFα, a cure for RA is still elusive. At present~     the reasons for the variation in clinical response are not known. The main aim of this study~     is to test the hypothesis that there are distinct molecular and cellular phenotypes present~     within the synovial tissue that define specific disease subsets and provide characteristic~     prognostic implications. In particular, the aim is to assess the relationship between the~     presence of ectopic lymphoneogenesis (ELN) within the rheumatoid synovial membrane and~     response to antiTNFα therapy.~   "
79352|NCT02528279|"~     Malaria is a protozoan infection transmitted by anopheline mosquitoes. The most severe forms~     are caused by Plasmodium (P) falciparum and to a much lesser extent by P. vivax.~      Although the interest in research on malaria has increased during the last years, yet little~     research is conducted on the neglected malaria species P. ovale and P. malariae. P. ovale~     being first described in 1922, it still remains unclear whether it displays dormant~     pre-erythrocytic liver stages, so called hypnozoites, or not. Primaquine, the only marketed~     drug with liver stage activity at present, can cause severe hemolysis in glucose-6-phosphate~     dehydrogenase (G6PD) deficient persons and methemoglobinemia. Because G6PD is widely spread~     in Central Africa, it is important to explore whether additional intake of liver-active~     medication is really needed and on this account further research to investigating new~     treatment options with liver stage activity should be conducted.~      While, due to widespread resistance, treatment recommendations for P. falciparum and mixed~     infections have switched from chloroquine to the safer applicable artemisinin-based~     combination therapies (ACTs), World Health Organization (WHO) guidelines still suggest~     chloroquine as first line treatment for P. malariae and P. ovale mono infections. Further~     studies assessing alternative treatment options are largely missing.~      Summing up the current situation for both topics shows the need for further research.~     Therefore this study aims to assess the evidence and characterize the frequency of relapses~     in P. ovale infections with respect to differences between its subspecies as well as the~     effectiveness of the ACT artemether-lumefantrine in P. malariae and P. ovale mono- and mixed~     infections.~   "
79353|NCT02528266|"~     This study is conducted to clinically assess safety and performance of the Polyganics nerve~     capping device for the treatment of symptomatic neuroma. There is sufficient clinical~     experience with regard to the safety of the commercially available nerve guide, NEUROLAC®.~     This new nerve capping device is identical in material and manufacturing. The exception is in~     design, where NEUROLAC® has two open ends, the nerve capping device has one closed (sealed)~     end. This study will be conducted to obtain data on the clinical performance of the capping~     device's ability to isolate the nerve end, resulting in a reduction of pain of experienced~     from the symptomatic neuroma and prevention of the reoccurrence of a symptomatic neuroma.~   "
79354|NCT02528253|"~     This study will investigate the efficacy and safety of tanezumab 5 mg and 10 mg administered~     by subcutaneous injection seven times at 8 week intervals (56 weeks). The primary objective~     of this study is to evaluate the effectiveness of tanezumab 10 mg and 5 mg compared to~     placebo for the treatment of chronic low back pain. Secondary objectives are to evaluate the~     long-term safety and effectiveness of tanezumab 10 mg and 5 mg compared to placebo for the~     treatment of chronic low back pain. In addition, the study will evaluate the effectiveness~     and long term safety profile of tanezumab treatment for chronic low back pain compared to~     tramadol Prolonged Release (PR), a medication commonly utilized for the treatment of chronic~     low back pain.~   "
79400|NCT02527655|"~     The Men on the Move Study is a randomized, controlled, feasibility study designed to address~     the health problem of physical inactivity in older men.~   "
79355|NCT02528240|"~     This study evaluates the effect of leucocyte and platelet rich fibrin (L-PRF) during~     endodontic microsurgery (EMS) on patient's post-operative comfort and periapical bone~     healing. Also the influence of an occlusive membrane barrier in EMS on the periapical bone~     healing will be studied. The trial design is an open randomized controlled clinical trial~     with a 2x2 factorial design. Half of the participants will receive EMS with L-PRF~     (experimental group), the other half without (control group). The control and experimental~     group will be divided in 2 subsequent groups: half of the participants will receive an~     occlusive membrane during EMS, the other half not.~   "
79356|NCT02528227|"~     The purpose of this study is to adminster one of two education programs to parents of preterm~     infants in the NICU to evaluate language and cognitive outcomes of their infants.~   "
79357|NCT02528214|"~     Primary Objective:~      To evaluate the efficacy of dupilumab, compared with placebo, for reducing the use of~     maintenance oral corticosteroids (OCS) in patients with severe steroid-dependent asthma.~      Secondary Objectives:~        -  To evaluate the safety and tolerability of dupilumab.~        -  To evaluate the effect of dupilumab in improving patient-reported outcomes.~        -  To evaluate dupilumab systemic exposure and the incidence of treatment-emergent antidrug~          antibodies.~   "
79358|NCT02528201|"~     A clinical trial to assess the effect of celecoxib 200 milligrams (mg) once daily and 400~     milligrams (mg) once daily compared to diclofenac three times daily in the treatment of~     Ankylosing Spondylitis (AS) for 12 weeks. This will be used to confirm the results of a prior~     6 week trial.~   "
79359|NCT02528188|"~     The purpose of this study is to compare the long-term joint safety and efficacy (pain relief)~     of the investigational study drug, tanezumab compared to non-steroidal anti inflammatory~     drugs (NSAIDs) in subjects with osteoarthritis of the hips or knees.~   "
79360|NCT02528175|"~     This pilot study hypothesizes that hyperthermia delivered via magnetic resonance-guided~     focused ultrasound (MRg-FU) is technically feasible and can be safely used in combination~     with concurrent reirradiation and chemotherapy for the treatment of recurrent rectal cancer.~     Twenty recurrent rectal cancer patients who are not candidates for surgery will be recruited~     for hyperthermia treatment delivered via MRg-FU concurrent with reirradiation and oral~     chemotherapy.~   "
79361|NCT02528162|"~     Prospective observational cohort study of women with gestational diabetes (GDM) based on the~     'International Association of Pregnancy Study Groups' (IADPSG) criteria. The overall aim is~     to evaluate the knowledge regarding GDM of women with GDM and to evaluate the satisfaction of~     women with GDM about the education they receive (given in group or individually). Normal~     routine care is followed and evaluated.~   "
79362|NCT02528149|"~     Fibromuscular dysplasia (FMD) is localized structural defects in the arterial wall, whose~     innate or acquired character is still unknown. This segmental non atheromatous injury, leads~     to stenosis of the arteries of small and medium caliber. Renal arteries are the most commonly~     affected with 60-75% of total fibrodysplasia. Three histological subtypes have been~     described: intimal, medial and peri-medial. They are not mutually exclusive and can be~     observed in the same patient.~      This is a rare blood disease, occurring in children and young adults. In this young~     population with long life expectancy, these aneurysmal lesion are associated with 10% risk of~     rupture. To date, no data have shown in the literature that FMD is link to genetic causes, or~     if there is specific histopathologic lesions for non-atherosclerotic renal artery aneurysms.~      To answer these questions, Cardiovascular Surgery Unit of the University Hospital of~     Saint-Etienne, French national reference center for renal artery surgery, in association with~     the Reference Center for Rare Vascular Disease in Paris, designed the first study for~     pathological and genetic characteristics of dysplastic renal artery aneurysms in young~     patients.~   "
79363|NCT02528136|"~     Randomized comparison of different cardiotoxicity of carbetocin and oxytocin.~   "
79364|NCT02528123|"~     The purpose of this study is to validate the safety and effectiveness of treating myopia~     (short-sightedness) higher than -10D using small incision lenticule extraction (SMILE) with~     the VisuMax femtosecond laser.~   "
79365|NCT02528110|"~     The efficacy of HIPEC in prevention of local recurrence, distant metastasis or peritoneal~     metastasis in locally advanced gastric cancer is not definite. The hypothesis of the trial is~     that radical gastrectomy plus HIPEC is superior to only radical gastrectomy in terms of~     overall survival.~   "
79366|NCT02528097|"~     Spontaneous bacterial peritonitis (SBP) is a common and frequently fatal complication of~     end-stage liver disease with a mortality of up to 10% primarily due to the development of~     kidney failure. Current standard practice is to treat this infection with broad spectrum~     antibiotics and salt-poor albumin administration on day one and three of treatment. In this~     study the investigators test the hypothesis that the administration of a second dose of~     albumin at 48 hours only to patients with renal insufficiency is as effective at preventing~     kidney failure as administering the second dose to all patients at 72 hours. In addition, a~     kidney function determined approach to albumin dosing may lead to substantial cost and~     resource saving from decreased albumin use without compromising treatment efficacy.~   "
79367|NCT02528084|"~     To determine if patients who undergo a 6-week online yoga exercise treatment differ from~     those who undergo a 6-week online standard exercise intervention and patients who do not~     undergo any treatment (the control).~   "
79368|NCT02528071|"~     Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease which involves respiratory~     muscles and can lead at short term to respiratory failure. The occurrence of respiratory~     failure is associated with morbidity and an increased mortality. To date, respiratory muscle~     weakness is predicted from the reduction of vital capacity, maximal inspiratory force,~     nocturnal symptoms and hypercapnia. Even taken together, the predictive value of these~     indices is low.~      The investigators hypothesize that an endurance test of diaphragmatic work would be more~     sensitive to respiratory muscle involvement than maximal respiratory force.~      Consequently, the investigators assessed diaphragmatic performance through an isocapnic~     hyperventilation test (IHT) in patients at the onset of ALS and, then regularly up to the~     occurrence of respiratory failure. The investigators make the hypothesis that IHT will be~     altered earlier than maximal inspiratory force~   "
79369|NCT02528058|"~     The excised ILM from 7 eyes of 7 patients with MTM including 7 eyes with macular~     retinoschisis and 4 eyes with foveal detachment but without any retinal break underwent~     vitrectomy with induction of posterior vitreous detachment and ILM peeling was examined to~     evaluate ultrastructure with electron microscopy.~   "
79371|NCT02528032|"~     Many studies have shown the benefits of cardiac resynchronization therapy (CRT) with~     biventricular pacing in patients with heart failure with left ventricular dysfunction. CRT~     restores contraction coordination between different regions of the left ventricle, which~     yields a significant improvement in LV systolic function, symptoms, exercise tolerance and~     quality of life. In the longer term, treatment with resynchronization induces a reverse~     remodeling of the left ventricle and a decrease in mortality and morbidity (hospitalization~     for heart failure). Nevertheless, even if a majority of patients treated with CRT feel the~     benefit, some (up to 40% depending on the response criteria of CRT) do not experience~     significant improvement (nonresponders). Echocardiography and imaging have not so far~     demonstrated their added value to optimize delivery of CRT. Monocentric promising work on~     limited numbers of patients, however, were carried out. Meanwhile, equipment for delivering~     CRT evolves and new probes with four poles stimulation of the left ventricle are now used.~     The objective of this research is to validate new sequences of ultrasound processing~     estimating the CRT. These tools are based on usual echocardiographic examination of patients~   "
79372|NCT02528019|"~     Inhibition of dipeptidyl peptidase-4 (DPP-4) or sodium-glucose co-transporter type 2 (SGLT2)~     has been proposed as a therapeutic target for type 2 diabetes. However, how DPP-4 inhibitors~     or SGLT2 inhibitors exert protective actions for diabetic complications in addition to their~     glucose-lowering effects remains unknown.~   "
79373|NCT02528006|"~     For adductor spasmodic dysphonia, there is a need for establishing a new therapy under the~     present circumstance where no standard therapy has been established yet and existing~     therapies fail to provide permanent effect. Evaluation of the efficacy of type 2 thyroplasty~     using titanium bridges will expand the therapeutic options available for adductor spasmodic~     dysphonia and establishment of a standard therapy.~   "
79374|NCT02527993|"~     Obesity is increasing worldwide and consequently the need for efficient treatment~     opportunities. Roux-en-Y gastric bypass (RYGB) is one of the most commonly performed~     bariatric procedures used in the treatment of severe obesity. The surgery results in~     significant and sustained weight loss and has a beneficial effect on blood glucose~     regulation.~      However, some patients experience the syndrome postprandial hyperinsulinemic hypoglycemia~     years after the operation, with symptoms varying from mild dizziness to confusion, loss of~     consciousness and seizures. Larger insulin and glucagon-like peptide 1 (GLP-1) responses to~     an oral glucose load are believed to play a role in the syndrome, which is not yet fully~     understood. There are no current treatment guidelines beside dietary recommendations.~      The purpose of this study is to compare different pharmacological treatments on daily blood~     glucose variations as well as postprandial hormonal and autonomous changes in subjects with~     symptoms of postprandial hyperinsulinemic hypoglycemia after RYGB.~   "
79375|NCT02527980|"~     The proposed research will provide in-depth, longitudinal data, based on real-time reports,~     which will address key priorities for the FDA including, increased understanding of the~     relations between electronic cigarette (e-cig) use and 1) nicotine dependence, 2) reductions~     in combustible cigarette (CC) use, 3) attempts to quit CC use and the success of those~     attempts, and 4) health-related outcomes such as biomarkers of exposure and carcinogenicity.~   "
79376|NCT02527967|"~     Although there is evidence for reducing complication rate and improving recovery after the~     implementation of Enhanced Recovery After Surgery (ERAS) protocols into colorectal surgery,~     most published papers include patients undergoing open resections. The aim was to analyse~     factors affecting recovery and length of stay (LOS) in patients after laparoscopic colorectal~     surgery for cancer combined with ERAS protocol.~   "
79377|NCT02527954|"~     In this study, investigators assess, using Fluorescence in situ Hybridization (FISH) and~     Comparative Genomic Hybridization (CGH) arrays for Preimplantation Genetic Screening (PGS),~     the incidence of aneuploidies in spermatozoa and embryos from infertile men with and without~     microdeletions who undergo assisted reproduction in their clinics.~   "
79378|NCT02527941|"~     A non-randomized, interventional, longitudinal clinical study to quantify the impact of~     bacterial vaginosis treatment on HIV susceptibility and genital immunology in Kenyan women.~   "
79379|NCT02527928|"~     Invasive fungal infections (IFIs) are complications that happen in the hospital, usually in~     patients hospitalized for long periods in intensive care units (ICU) after invasive~     procedures, and in specific populations, such as cancer patients. The aim of this study is to~     determine the direct and indirect hospital costs with different formulations of amphotericin~     B (deoxycholate, lipid complex and liposomal) in different public and private hospitals in~     the city of Curitiba, Paraná, Brazil.~   "
79380|NCT02527915|"~     The purpose of this study is to assess whether electronic consultations between primary care~     providers and psychiatrists affects mental health services delivered in primary care~     settings.~   "
79381|NCT02527902|"~     The estimation of the cardiovascular risk in the general population must take into account~     small renal disturbances, as the microalbuminuria. Conversely certain parameters of the~     cardiovascular risk influence the evolution of renal diseases, for example the arterial high~     blood pressure.~      The measure of the activity of the autonomous nervous system, and especially the~     quantification of its variability, is a means to estimate the cardiovascular risk. The~     investigators formulate the hypothesis that the variability of the autonomous nervous system~     is an additional clinical element for the evaluation of the evolutionary risk of renal~     diseases.~      The aim of this study is to compare the variability of the autonomous nervous system during~     the various evolutionary stages of the renal disease.~      The renal disease studied will be IgA nephropathy (IgNA). IgNA is a histologically defined~     glomerulonephritis (rela biopsy) by the presence of deposits immunoglobulin A (IgA) in the~     renal mesangium (at list 1+) by immunofluorescence.~   "
79382|NCT02527889|"~     The purpose of the study is to evaluate the effect of resistive exercise on forearm blood~     flow and tissue oxygenation among breast cancer survivors with or at risk for breast~     cancer-related lymphoedema (BCRL).~   "
79383|NCT02527876|"~     The purpose of this study is to evaluate how physical activity levels change in young adults~     when they start a specific exercise program.~   "
79411|NCT02527512|"~     This study will evaluate the safety of povidone-iodine irrigation in pediatric spinal~     patients by collecting pre- and post-operative safety labwork. Furthermore, the efficacy of~     povidone-iodine and normal saline irrigation at reducing bacterial contamination of the~     surgical wound will be measured by collecting cultures before and after irrigation.~   "
79384|NCT02527863|"~     Tolvaptan is a selective vasopressin receptor antagonist (V2R) that increases free water and~     sodium excretion. Inhibition of V2R increases vasopressin concentration in plasma, which~     stimulates V1-receptors in the vascular bed and may change both central and brachial~     hemodynamics and plasma concentration of vasoactive hormones.~      The purpose of the study is to measure the effects of tolvaptan on renal handling of water~     and sodium, systemic hemodynamics and vasoactive hormones at baseline and during nitric oxide~     (NO)-inhibition with L-NG-monomethyl-arginine (L-NMMA) in patients with autosomal dominant~     polycystic kidney disease.~   "
79385|NCT02527850|"~     Low level laser therapy (LLLT) was shown to affect muscle performance and fatigue. The aim of~     this study is to investigated the effect of B-cure laser on muscle performance and recovery~     after intense exercise.~   "
79386|NCT02527837|"~     The purpose of this study is to investigate how the effect of infused sodium nitrite differs~     in hypertensives compared to healthy age and sex matched controls. The effects on renal~     handling of nitrite, nitrate, sodium and water, plasma concentrations of vasoactive hormones,~     peripheral (brachial) and central blood pressure will be evaluated.~   "
79387|NCT02527824|"~     This study will conduct a phase II study of triple combination with oxaliplatin, irinotecan,~     and S-1 as the first-line chemotherapy in patients with advanced biliary tract cancer.~   "
79388|NCT02527811|"~     1. Explore the efficacy of Ulinastatin use in improving post-operative pulmonary~          insufficiency and safety in pediatric patients undergoing scheduled CPB open heart~          surgery to treat Complex Congenital Heart Disease~        2. Explore the efficacy of Ulinastatin use in improving intraoperative hemodynamic~          instability as well as other post-operative organ recuperation and its impact on~          hospital stay & cost~   "
79389|NCT02527798|"~     This study will describe the safety of furosemide in premature infants at risk of~     bronchopulmonary dysplasia and determine the preliminary effectiveness and pharmacokinetics~     (PK) of furosemide. Funding Source - FDA OOPD~   "
79390|NCT02527785|"~     This study will conduct a phase II study of triple combination with oxaliplatin, irinotecan,~     and S-1 as the first-line chemotherapy in patients with advanced gastric cancer.~   "
79391|NCT02527772|"~     The purpose of this study is to determine that Liposomal Doxorubicin(LD) plus~     Gemcitabine(GEM) is superior to Oxaliplatin（OXA） Plus Fluorouracil/Leucovorin(FOLFOX4) in~     prolonging progression-free survival（PFS） in patients with Advanced Hepatocellular Carcinoma.~   "
79392|NCT02527759|"~     The purpose of this study is to examine the relative predictive ability of the derived~     monitoring instrument to determine post discharge instability and 30-day outcomes in patients~     discharged with HF. The primary hypothesis is that variables in the monitoring instrument,~     individually and combined, identify risk for 30-day outcomes. Clinical indicators of dyspnea,~     fatigue, orthopnea, dyspnea with exertion, daily weight, edema, heart rate, blood pressure,~     mental condition, medication adherence, and overall well-being will be reported by~     participants on a daily basis and considered indicators for 30-day outcomes of stability,~     re-hospitalization, or mortality.~   "
79393|NCT02527746|"~     A Phase I, dose escalation study to evaluation the safety and~     pharmacokinetics/pharmacodynamics of F-627 in female breast cancer patients who received up~     to 4 cycles of Epirubicin and Cyclophosphamide. 18 patients (6 patients each cohort) were~     assigned to three escalated dose cohorts of 80, 240 and 320 µg/kg.~   "
79394|NCT02527733|"~     The efficacy of anti-vascular endothelial growth factor (VEGF) therapy for branch retinal~     vein occlusion (BRVO) is shown, but its effect on retinal sensitivity is not fully~     investigated. The purpose of this study is to compare the changes in retinal sensitivity~     after ranibizumab therapy or combination therapy of ranibizumab and laser photocoagulation in~     eyes with BRVO.~   "
79395|NCT02527720|"~     The investigators plan to establish the efficacy of a novel breathing-based mindfulness~     training (BBMT, a much simplified, easy-to-use version of standard MM) for problem drinking,~     and test whether impulsivity mediates this effect among a sample of student problem drinkers~     (i.e., > 8 on AUDIT, the problem drinking Screening Test). The specific aims of this pilot~     study are as follows:~        1. to modify and further develop the easy-to-use BBMT program for directly targeting~          impulsivity to produce an indirect reduction in problem drinking among college students;~        2. to investigate the feasibility and preliminary efficacy of applying BBMT for reducing~          problem drinking with a pilot randomized controlled trial (RCT);~        3. to examine changes in impulsivity, as measured by both behavioral and self-report~          assessments, as one of the possible mediators in the effect of BBMT on problem drinking,~          with control for changes in perceived stress and anxiety.~   "
79396|NCT02527707|"~     A phase 2, open-label study to evaluate the safety, tolerability, pharmacokinetics, and~     pharmacodynamic activity of titrating-dose lonafarnib in combination with ritonavir in~     patients chronically infected with hepatitis delta virus~   "
79397|NCT02527694|"~     This study aims to compare the quality of emergency medical services cardiopulmonary~     resuscitation between flexible stretcher and standard stretcher during ambulance transport to~     hospital among out-of-hospital cardiac arrest patients.~   "
79398|NCT02527681|"~     The primary objective is to characterize the pharmacokinetics of single doses of ceftobiprole~     in neonates and infants aged ≤3 months. The secondary objective is to evaluate safety and~     tolerability of ceftobiprole in neonates and infants aged ≤3 months.~   "
79399|NCT02527668|"~     Young postmenopausal women with osteopenia / or women with osteoporosis and a FRAX score~     below pharmacologic treatment indication have limited treatment options in the prevention of~     osteoporosis/treatment of osteopenia. Further, there is a concern about long-term side~     effects of bisphosphonate treatment among young postmenopausal women, and hormone replacement~     therapy has been controversial. In a pilot study 20 microgram Calcifediol Hy.D improved~     several muscle related function in this target population within 4 months of treatment, which~     can help to prevent falls and associated bone fractures. Thus the main aim of this study is~     to test whether Calcifediol Hy.D at a daily dose of 20 μg / day improves muscle function~     (lower extremity test battery) compared with (1) placebo and compared with (2) 3200 Vitamin~     D3 IU per day, at 3 and 6 month follow-up. As a secondary and exploratory objective of this~     study, the investigators will compare the beforementioned doses on muscle strength and the~     quality of the bones, beside muscle mass, body composition and systolic and diastolic blood~     pressure measurements.~   "
79401|NCT02527642|"~     This is a randomized, controlled, single-center study in otherwise healthy infertile female~     subjects undergoing in vitro fertilization (IVF). The subjects recruited for this study will~     be among those patients who have been diagnosed with infertility and are planning to undergo~     IVF at the centers where this study is being performed. The patients will have undergone the~     usual informed consent procedure at the center.~   "
79402|NCT02527629|"~     Evaluation of decellularized human heart valves for aortic heart valve replacement in~     comparison to current valve substitutes.~      Safety endpoints include cardiovascular adverse events, time to re-operation, re-intervention~     and explantation.~      Efficacy endpoints include freedom from valve dysfunction and hemodynamic performance.~   "
79403|NCT02527616|"~     This is a single-blinded, randomised, crossover investigation comparing the investigational~     device using intra-coronary (IC) Adenosine infusion to the standard intra-venous (IV)~     infusion method used for obtaining FFR measurements. All subjects requiring on a clinical~     basis a pressure wire assessment of intermediate coronary artery stenosis(es) will be~     eligible to take part in the investigation.~   "
79404|NCT02527603|"~     To compare the results and efficacy of the self-assisted Boss-Holzach-Matter maneuver for~     anterior shoulder dislocation and the Spaso method performed by a physician.~   "
79405|NCT02527590|"~     The stimuli used in the evoked potentials are electrical or laser. They are started and~     synchronized with the collection of the EEG by signals TTL (transistor-transistor logic).~     Investigators propose to validate a pneumatic stimulator delivering the compressed air sync~     with the EEG. It has two advantages over existing stimuli: Is capable of inducing in patients~     an allodynic response, excessive, painful, in response to a stimulation painless rarely~     obtained with laser or electrical stimuli. Therefore, the pneumatic stimulation is a means to~     study allodynic evoked potentials unknown to date.~      It must be possible with a single stimulator to explore non-painful sensations and allodynic~     sensation , compare them with one device. The differences are the abnormal responses. This~     validation assumes evoked potential recording 1. somatosensory (low stimulation) then 2.~     allodynic (only in patients). The study therefore provides for the registration 100 potential~     for each of these two modalities in patients and only for the painless pneumatic modality in~     volunteers.~   "
79406|NCT02527577|"~     The indications liver cancer surgery currently booming due to the increase in surgical~     techniques and instruments for a more secure resection of liver tissue with a significant~     reduction in bleeding or surgical complications. This allowed to expand surgical indications~     in the most fragile patients so assuming optimized anesthetic care.~      So far, the technique of analgesia reference to this surgery remains administration of~     morphine analgesia via a device controlled by the patient (PCA) for epidural analgesia is~     against-indicated because of induced bleeding disorders by surgery.~      Rafi then McDonnell in 2007 have described a new technique of loco regional anesthesia, the~     abdomen of the Transversus Abdominis Plane (TAP) nerve block(TAP), which allows selective~     anesthesia of the abdominal wall. But parietal pain related muscular and nervous sagging~     surgical approach represent a significant share of post operative pain.~      This study proposes an evaluation of the abdomen transverse blocks in hepatectomy.~   "
79407|NCT02527564|"~     The purpose of this study is to evaluate the efficacy of suvorexant, added to existing~     medications, for treatment-resistant insomnia in individuals with bipolar disorder. The~     investigators hypothesize that participants receiving suvorexant for one week will experience~     significantly greater improvement in sleep duration compared to participants receiving~     placebo.~   "
79408|NCT02527551|"~     Fibromyalgia syndrome (FMS) is a common chronic musculoskeletal pain disorder of unknown~     etiology, characterized by generalized body pain, hyperalgesia and other functional and~     emotional comorbidities. Women are predominantly affected. Long term prognosis of FMS might~     be severe by its physical and psychological consequences. The etiology of FMS remains unknown~     but recent studies suggest a disorder of central pain modulation, neurotransmitters,~     sympatho-adrenal and hypothalamic-pituitary-adrenal system and peripheral muscles issues.~     Indeed, muscular abnormalities with a decrease of ATP and micro vascularization have been~     reported, inducing muscle weakness and local biochemical changes that participate to pain~     hyper sensitivity. Treatment of FMS is only symptomatic, often difficult, associating~     pharmacological and non-pharmacological therapies. Massages are largely used in FMS and are~     included in chronic pain management recommendations.~      Massages are recognized as haptic when the hands of the practitioner move on the skin of the~     patient; haptic massage is superficial if the pressure applied on the skin is similar to the~     weight of the hand and it's a deep haptic massage when the pressure applied is over the~     weight of the hand, allowing reaching deep muscle structure. Deep haptic massages are largely~     used for athlete to improve muscle recovery and treat tendinitis. All massages evaluate in~     FMS are superficial haptic massage; they are recognized as efficient on pain, anxiety and~     depression if they are performed at least on 5 weeks but these effects are transient et~     remain to be optimized. The efficacy of deep haptic massage has not been evaluated in~     pathological conditions. The investigators hypothesize that, in FMS patients, deep~     intramuscular maneuvers may solicit sensitive receptors, stimulating large caliber fibers A~     lemniscal conveyed by the way that bypass chronic pain information carried by the C fibers of~     the extra-lemniscal pathway: this is the Gate Control theory for inhibiting pain~     information.~   "
79409|NCT02527538|"~     The beach chair position for shoulder operation induces hypotension during general~     anesthesia. Hypotension is induced by decreased preload and contractility due to anesthesia.~     Masimo is a pulse oximetry which shows pleth variability index noninvasively. The pleth~     variability may predict the hypotension during beach chair position.~   "
79410|NCT02527525|"~     The incidence of type 1 diabetes (T1D) in young children (age <6 years) is rising. Disease~     management guidelines offered by the ADA and other diabetes care organizations place a high~     burden of responsibility onto these children's parents and caregivers to check blood sugar,~     administer insulin, and monitor diet and physical activity to maintain tight glycemic~     control. Unfortunately, this occurs at a vulnerable time in life when children's behavior is~     unpredictable, their T1D is difficult to control, parenting stress is elevated, and~     caregivers are strained by normal child caretaking routines. T1D education and support tends~     to be highly concentrated at diagnosis/during the inpatient stay, and requires rapid~     knowledge and skill acquisition on the part of parents. Not all families respond equally well~     to this teaching model, and many need more guided practice, problem-solving assistance, and~     behavioral supports than can be offered in a one-size-fits-all patient education approach.~     Our research will attempt to better meet the needs of individual families through a clinical~     behavioral stepped care intervention for T1D in parents of young children by using real-time~     glycemic control and [parental depression indices] to intensify management support when~     indicated. Primary caregivers of young children (<6 years) newly diagnosed with T1D will be~     randomized to either a 3-step stepped care (treatment) or usual care (comparison) condition.~     Stepped care components include: T1D management support delivered by trained lay parent~     consultants (Step 1), T1D parenting strategies and mealtime behavior management delivered by~     bachelor's level behavioral assistants (Step 2), and individualized diabetes~     education/management planning with a certified diabetes nurse educator and [consultation with~     a diabetes team clinical psychologist] (Step 3). Biomedical and psychosocial measurements~     (including A1c, depressive symptoms, mealtime behavior, parenting stress, quality of life)~     will occur at baseline and 3-month intervals for up to 15 months post-diagnosis. The results~     of this work will ultimately lead to a more practical approach to T1D education and~     management that can be translated more easily into a variety of clinical practice settings to~     support young children's T1D management.~   "
79412|NCT02527499|"~     The four purposes of this study are: 1) to examine the feasibility of combining modified~     ride-on cars with bimanual training (ROCBT) on mobility, socialization and motor function in~     toddlers with disabilities; 2) to quantify whether toddlers with disabilities are able to~     have more manual explorations and social interactions with ROCBT through observation and~     wrist-worn accelerometers; 3) to determine the critical factors of using the modified ride-on~     toy car on family perceptions and participation.~      Independent mobility is believed to be essential for perceptual-motor, cognition, language~     and social skill development. It is important to increase independent mobility in toddlers~     with disabilities and further enhance their development, especially socialization. Assistive~     and power mobility devices allow toddlers with disabilities to move independently within~     their environment and may increase the opportunities to explore and interact with people and~     environment. However, issues to consider before prescribing an assistive device include~     factors such as age, accessibly to community environments, cost, and social acceptance of the~     device and the adaptability of the device to growth. To address these limitations and meet~     toddlers' needs, the concept of using modified ride-on toy cars in therapy becomes a novel~     application. Study has demonstrated the use of toy cars enhanced a child's motivation,~     socialization and family participation. This study is further to combine the use of~     customized, modified ride-on toy cars with bimanual training, to enhance the independent~     mobility, manual exploration and socialization through low-cost, family-centered approach. It~     will also improve family's understanding of children's capabilities, which improve their~     development.~      Investigators will recruit 75 children with who are between 1 to 3 years old and diagnosed as~     motor delay (>1.5 sd). They will be randomly assigned to one of the following three groups:~     ROCBT treatment group, early mobility training group and regular therapy group. The whole~     study duration will be 18 weeks, including 9-week intervention and 9-week follow-up; the~     total amount of treatment will be equal for two groups. Standardized assessments are provided~     for a total of three times during the study, including the time before and after the~     intervention and in the end of the follow-up phase. The ROCBT and early mobility training~     programs will be administered by the therapist and include 120 minutes/per session, 2~     sessions/per week. The research team will visit the hospital once/per week to provide 60~     minutes videotaping and wearing wrist-worn accelerometers. The regular therapy group will~     continue their regular therapy without any additional car driving training. The research team~     will visit them once/per week for the assessments. The assessments include standardized~     measurements and behavior coding from the videotapes and accelerometers. The findings of this~     study will help to understand the feasibility and effectiveness of combining the low-tech~     modified ride-on cars with bimanual training on advancing children's mobility and~     socialization. They can be used in the clinic or school and are a low cost alternative or~     addition to other mobility devices. They may provide a novel therapeutic tool to improve~     mobility, socialization, family participation and development.~   "
79413|NCT02527486|"~     This is a multicenter, prospective observational cohort study, in which patients with chronic~     airway diseases including chronic obstructive pulmonary disease(COPD), asthma, asthma-COPD~     overlap syndrome (ACOS) will be recruited.~   "
79414|NCT02527473|"~     In an attempt to enhance OHCA survival by increasing bystander CPR rate, this study will~     assess the effectiveness of the new basic life support with dispatch assistance (DA-BLS)~     education program through a simulation experiment.~      This study aims to determine whether the new DA-BLS program for possible home bystanders is~     associated with improved CPR quality. We expect home bystanders who were trained with new~     DA-BLS education program to show better compliance with CPR instructions given by dispatcher~     via telephone along with improved CPR quality.~   "
79415|NCT02527460|"~     Background:~      HIV can sometimes cause HIV-associated neurocognitive disorder, or HAND. HAND is~     HIV-associated neurocognitive disorder. It can affect memory, thinking, or concentration. It~     can cause mood changes. HAND may be caused by HIV hiding in the central nervous system then~     causing inflammation. Researchers want to see if a drug for inflammation (Anakinra) can help~     people with HIV.~      Objective:~      To see if a drug for inflammatory diseases is safe for people with HIV-infection on~     antiretroviral therapy.~      Eligibility:~      Adults 18-61 years old with HIV who are enrolled in another study.~      Design:~      Participants will be screened with medical history, physical exam, and blood and urine tests.~      Participants will have up to 15 study visits over 16 weeks.~      At study visit 1, participants will have:~        -  Screening tests repeated.~        -  Brain magnetic resonance imaging (MRI) scans. They will lie on a table that slides into~          a metal cylinder in a strong magnetic field. They will get a dye inserted by a thin~          plastic tube in a vein.~        -  Lumbar puncture. The lower back will be numbed. A needle will collect fluid from between~          bones in the back.~        -  Tests of memory, thinking, and attention. Participants may also fill out forms and do~          tasks.~      Participants will learn how to inject the study drug. Over 8 weeks, they will give themselves~     the study drug at home every day. They will do up to 3 injections at once. They will write~     down their injections and any side effects.~      Participants will have 5 weekly visits while taking the study drug. They will answer~     questions and have blood drawn.~      At weeks 8 and 16, they will have a visit that repeats visit 1.~   "
79416|NCT02527447|"~     Background:~      -Acute myeloid leukemia (AML) is a cancer of the white blood cells. It can be fatal. Standard~     treatment involves intensive chemotherapy. Not all treatment works. AML that has not~     responded to treatment (refractory) or that has returned after treatment (relapsed) is~     high-risk even with treatment. Success of therapy is normally determined after 28 to 56 days.~     This study will see if a blood test on day 4 of therapy can help identify earlier those who~     will not respond.~      Objectives:~      -To see if a blood test on day 4 of therapy can help identify those who will not respond to~     treatment for AML.~      Eligibility:~      -People ages 18-70 who have refractory or relapsed AML and have had at least one previous~     therapy for it.~      Design:~        -  Participants will be screened with medical history, physical exam, and blood tests.~        -  Participants will have:~        -  Several blood tests.~        -  Bone marrow exams: a needle is inserted into the hip to take cells from the bone marrow.~        -  Echocardiogram: a small probe is held to the chest to take pictures of the heart.~        -  ECG: soft electrodes are stuck to the skin. A machine records the heart s signals.~        -  CT scans: they will lie in a machine that takes pictures of the body.~        -  Standard chemotherapy.~        -  Possible transfusions of blood products such as red blood cells or platelets.~        -  Participants will be expected to stay in the study typically for 2 3 months. This will~          include inpatient treatment. Inpatient stay normally will be 1 or 2 months.~   "
79417|NCT02527434|"~     A Phase II, Multi-Center, Open-Label Study of Tremelimumab Monotherapy in Patients with~     Advanced Solid Tumors~   "
79418|NCT02527421|"~     To evaluate the potential of DFD-01 (betamethasone dipropionate) Spray, 0.05% to suppress the~     hypothalamic-pituitary-adrenal (HPA) axis.~   "
79419|NCT02527408|"~     This study will address the feasibility of using wrist-worn fitness trackers to monitor~     hospital inpatients. The study is being conducted in the Intensive Care Unit where patients~     are closely monitored, in order to provide gold standard measurements of heart rate, and~     accurate estimates of sleep quality.~   "
79420|NCT02527395|"~     The purpose of this prospective study is to investigate how close Heat Pain Detection~     Threshold is associated with the area of secondary hyperalgesia, elicited by the clinical~     pain model Brief Thermal Sensitization.~      Furthermore we wish to investigate how close the clinical pain model: Pain during 1 min.~     heating of the skin (45 degrees celsius), and the psychological tests, Pain Catastrophizing~     Scale and Hospital Anxiety and Depression Scale are associated with the area of secondary~     hyperalgesia, elicited by the clinical pain model Brief Thermal Sensitization.~   "
79425|NCT02527330|"~     Heart failure from myocardial iron deposition is a severe complication for patients with~     hematological disorders who need repeated blood transfusions. Increased cardiac iron content~     impacts the contractility of cardiomyocytes and can also lead to myocarditis, pericarditis,~     and arrhythmias. The severity of cardiac dysfunction depends on the amount of iron deposited~     in the myocardium.~      Cardiovascular magnetic resonance (CMR) imaging is used as noninvasive method to evaluate the~     amount of iron in the heart. Myocardial T2* value has been shown to correlate well with~     biopsy-derived iron concentration in the heart, and myocardial T2* values less than 20ms~     (indicating elevated iron) were found to be associated with LV dysfunction and improve in~     concert with LV function during recovery. The majority of the recent studies about myocardial~     iron overload and the effect of iron chelation therapy were focused on patients with~     transfusion-dependent hematological disorder, especially beta-thalassemia major.~      The objective of this 3-year project is to evaluate myocardial iron deposition in patients~     with heart failure, induced by variable causes. With myocardial T2* imaging, the~     investigators will analyze the decreased signal intensity in the ventricular septum and~     quantitatively acquire the T2* value as marker for myocardial iron deposition. The first year~     is a cross-sectional study. The investigators aim to compare the severity of myocardial iron~     deposition of normal subjects and that of stable HF patients in recovery with normal or~     impaired ejection fraction (EF). Total 60 subjects will be enrolled, with 20 subjects in each~     group. In the 2nd and 3rd years, the investigators plan a prospective longitudinal study of~     40 subjects. Enrolled patients will be evaluated with cardiac T2* imaging at three time~     points, i.e., disease onset, 6 months and one year after treatment, and will be followed up~     until the end of this project (1.5~3-year follow up). In total 120 MR scans will be performed~     in the 2nd and 3rd years. The presence and severity of myocardial iron deposition will be~     correlated with the disease course, patient biochemistry data and clinical outcome.~   "
79426|NCT02527317|"~     This is a prospective, non-interventional, single arm study, which is examining doxorubicin~     and cyclophosphamide (AC) once every 2 weeks with lipegfilgrastim support in early breast~     cancer.~   "
79427|NCT02527304|"~     This pilot clinical trial studies adaptive staged stereotactic body radiation therapy (SBRT)~     in treating patients with spinal metastases that cannot be removed by surgery. SBRT is a~     specialized radiation therapy that delivers a single, high dose of radiation directly to the~     tumor and may kill more tumor cells and cause less damage to normal tissue. Adaptive SBRT~     uses information gathered during treatment to inform, guide, and alter future radiation~     treatments. Staged SBRT uses multiple treatments separated by 2-3 weeks. Giving adaptive~     staged SBRT may work better in treating spinal metastases that cannot be removed by surgery.~   "
79428|NCT02527291|"~     We hypothesized that the stress of cardiac surgery and cardiopulmonary bypass can cause~     reactivation of a latent CMV infection and that reactivation might be more prevalent in~     patients with complicated post-operative course. The study aims are:~        -  To study whether cardiac surgery is a trigger for latent CMV reactivation and to compare~          reactivation rate between sub groups of patient with complicated post-operative course~          and non complicated post operative course.~        -  To study the relationship between expression IL28 SNP rs12979860 and the risk of CMV~          replication in the non immunocompromised patient undergoing cardiac surgery.~   "
79429|NCT02527278|"~     The research questions are:~        1. What is the proportion of women undergoing hysterectomy after hysteroscopic~          sterilization or laparoscopic tubal ligation?~        2. What is the proportion of women undergoing salpingectomy, salpingostomy, or hysteroscopy~          after hysteroscopic sterilization or laparoscopic tubal ligation?~        3. What is the proportion of women who have a diagnosis of pelvic pain after hysteroscopic~          sterilization or laparoscopic tubal ligation?~   "
79430|NCT02527265|"~     Primary Objective:~      -To assess the safety and tolerability of Afrezza in children ages 4 to 17 years with type 1~     diabetes mellitus (T1DM).~      Secondary Objectives:~        -  To assess the ability to titrate the prandial and supplemental doses of Afrezza at each~          meal.~        -  To assess pharmacokinetics (PK) following a prandial dose of Afrezza in children ages 4~          to 17 years with T1DM.~   "
79431|NCT02527252|"~     The purpose of the current randomized clinical trial was to analyze the effectiveness of~     craniosacral therapy on disability, pain intensity, kinesiophobia, quality of life, isometric~     endurance of trunk flexor muscles, mobility, and oxygen saturation, blood pressure, cardiac~     index, and biochemical estimation of interstitial fluid in individuals with chronic low back~     pain.~   "
79432|NCT02527239|"~     Pompe's disease is a very rare condition which causes weakness of the respiratory muscles and~     may therefore cause symptoms of breathlessness or even respiratory failure, requiring the use~     of a ventilator at night. Recently a treatment for this condition has become available as~     well as a simple diagnostic test. However, we believe it is possible that there are patients~     with this condition who are presently undiagnosed attending respiratory clinics.~      We would like to complete an observational study of patients with respiratory muscle weakness~     of an unknown cause, who are attending respiratory clinics at two London centres, to~     determine whether patients attending these services have undiagnosed Pompe's disease.~   "
79433|NCT02527226|"~     This is a protocol to govern the prospective trial of facial nerve monitoring in patients~     undergoing parotidectomy with an eye towards interpreting if the facial nerve monitor~     provides useful information to operating surgeons and if the information provided by the~     facial nerve monitor can predict degrees of postoperative facial nerve paresis.~      Additionally, the study will determine if performing daily facial rehabilitation exercises~     provides a benefit in reducing time to recovery of temporary post-parotidectomy paresis.~   "
79434|NCT02527213|"~     To evaluate the efficacy of Sodium Thiosulfate (STS) compared to placebo, in reducing~     analgesic requirement in subjects with calcific uremic arteriolopathy (CUA) during an initial~     28-day treatment phase.~   "
79435|NCT02527200|"~     This trial is conducted globally. The aim of this trial is to investigate the effect of~     liraglutide for weight management in paediatric subjects with Prader-Willi Syndrome.~   "
79436|NCT02527187|"~     The main objective is to evaluate the concentration of allergen extract of Betula verrucosa~     that elicit a papule equivalent to that produced by a solution of histamine dihydrochloride~     10 mg / ml in size.~   "
79437|NCT02527174|"~     This is a Phase I clinical trial to determine the maximum tolerated dose (MTD) of the~     polo-like kinase-1 inhibitor volasertib which can be safely combined with idarubicin plus~     cytarabine induction chemotherapy for previously untreated patients with acute myeloid~     leukemia. (AML).~   "
79438|NCT02527161|"~     This is a prospective, non-randomized, longitudinal study of the clinical outcomes of~     participants that receive the Stryker Triathlon® Total Knee System for Total Knee~     Arthroplasty implanted using ShapeMatch® Cutting Guides.~      Health status and functional outcome measures will be recorded to quantify functional status~     of subjects before surgery and at each follow-up interval. This sub-study involved the~     assessment of the placement of the ShapeMatch® Cutting Guides intraoperatively and~     post-operatively.An assessment of post-operative patient outcomes compared to pre-operative~     status was also analysed.~   "
79439|NCT02527148|"~     This is a prospective, randomized, longitudinal study of the clinical outcomes of~     osteoarthritis patients treated by two different alignment philosophies for total knee~     replacement. In this study ShapeMatch® cutting guides will be compared to the conventional~     approach.~   "
79440|NCT02527135|"~     The purpose of this study is to determine whether regularly scheduled HIV sensitization text~     messages (SMS) are effective in increasing HIV testing rates among young women in Kenya.~   "
79441|NCT02527122|"~     Four concentrations of Dermatophagoides pteronyssinus and Dermatophagoides farinae allergen~     extracts, together with a positive and negative control, using 10 mg/ml histamine~     dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be~     tested in every patient in duplicate on the volar surface of the forearm..~   "
79442|NCT02527109|"~     The objective of the study is to examine the effect of Nifedipine, applied intra-anally~     through our drug delivery device, on rectal pain severity in anal fissure patients that are~     being managed with conservative treatment.~   "
79443|NCT02527096|"~     The principal objective is to evaluate the antiviral efficacy of 48 weeks treatment with the~     two-drugs combination dolutegravir(Tivicay®) and lamivudine(TEpivir®) in HIV-1 infected~     patients virologically suppressed with triple HAART.~   "
79444|NCT02527083|"~     Research suggests that the type of anesthesia used for surgery may affect intraoperative~     stress hormone levels. There is also data to support that an increased level of stress~     hormones leads to increased pain after surgery. The primary aim of this study is to determine~     the effect of anesthesia type on long term pain after hernia surgery. In this study, patients~     undergoing inguinal hernia repair will be randomized to an anesthetic group, either Total~     Intravenous Anesthesia (TIVA) maintained with propofol or Balanced Inhaled Anesthesia (BIA)~     maintained with sevoflurane. This will allow us to look at any differences in short and~     long-term pain after hernia repair depending on type of anesthesia received.~   "
79445|NCT02527070|"~     Photoplethysmography (PPG) is a simple uncalibrated optical method of monitoring variations~     in skin blood volume. The objective of the current study is to investigate a potential~     relationship between MRT (minimum rise time, in time units) a measure derived from PPG and~     the state of microvessels.~      This study includes a 1-2 hour single session per subject during which PPG and other~     microvascular and systemic variables will be monitored in response to non-invasive~     interventions that are known to elicit microvascular responses.~   "
79446|NCT02527057|"~     Esophageal carcinoma is a lethal disease, causing more than 400,000 deaths annually~     worldwide. Primary surgery results in microscopically positive resection margins (R1) in 25%~     patients, and the 5-year overall survival(OS) for such patients rarely exceeds 40%.~     Concurrent chemoradiation followed by surgery results in better survival than single-modality~     treatments, and thus National Comprehensive Cancer Network(NCCN) recommends concurrent~     chemoradiation as preoperative or definitive treatment for patients with stage II or III~     esophageal cancer. However, neoadjuvant chemoradiation may not be effective in some subgroup~     of these patients, and its toxicity can increase perioperative mortality and delay or~     preclude surgery. The ability to distinguish tumors that will respond or not respond to such~     therapy remains an urgent priority. Diffusion-weighted magnetic resonance imaging(DW-MRI) is~     based on the extent of mobility of water protons, as quantified by the apparent diffusion~     coefficient (ADC). The ADC is a measure of the extent of free diffusion of water molecules~     within tissues, which is mainly influenced by cell organization, size, and density. Cell~     death leads to a loss of cell membrane integrity and density and leads to increases in ADC~     values. The ADC has emerged as a potential biomarker of response to cancer therapy. However,~     no one has published findings regarding the potential correlation between changes in ADC and~     response of esophageal cancer to chemoradiation. Clarifying the potential predictive value of~     DW-MRI for predicting response to such therapy is important for the delivery of appropriately~     tailored treatment.~      Investigators hypothesized that DW-MRI can predict the success (or failure) of neoadjuvant~     chemoradiation in esophageal squamous cell carcinoma（ESCC）, hence identify patients at high~     risk of treatment failure from such therapy. Investigators will test this hypothesis with two~     specific aims: (1) assess the ability of ADC to predict pathologic response to treatment; and~     (2) assess the ability of ADC to predict disease-free survival and overall survival.~   "
79447|NCT02527044|"~     Assessing coronary graft functionality 6 months after in patients with complete arterial~     coronary artery bypass grafting.~   "
79448|NCT02527031|"~     Cardiac arrest (CA) affects approximately 40,000 people in France. It is still a major cause~     of death in a young population. Management of CA is defined by international recommendations,~     detailed by learned societies in each country. It includes several links that are~     interconnected for its optimisation. Despite all these improvements, no progress, or little~     has been made in the survival of CA victims over the past few years in industrialised~     countries, and the survival rate in France is 3% to 5%.~      Refractory cardiac arrest is defined as failure, after 30 minutes of specialised~     resuscitation. It used to be the standard to admit that there was no hope of spontaneous~     cardiac activity and satisfactory neurological recovery after this period, except in cases of~     CA with neuroprotection (intoxication, hypothermia).~      External circulatory support such as extracorporeal membrane oxygenation (ECMO) makes it~     possible to replace the circulatory activity of the myocardium and the respiratory activity~     of the lungs.~      In in-hospital cardiac arrest (CA) some teams use ECMO with an improvement in the survival~     rate of 20% in comparison to standard resuscitation. This use demonstrates the possibility of~     neurological recovery independent of the recovery of spontaneous cardiac activity which can~     be differed.~      These results encouraged the use of ECMOs in cases of out-of-hospital refractory cardiac~     arrests. Patients who are victims of CA are resuscitated for 30 minutes on the spot where the~     CA occurs. They are then transferred to a specialised centre. The significant improvement in~     survival noted in in-hospital CAs was not observed in the French series of studies concerning~     out-of-hospital CAs. This survival is currently estimated at 4%. This difference can be~     partly explained by the difference in time between the beginning of cardiac massage and the~     implementation of circulatory support by ECMO (low flow period). This time period is~     directly correlated to survival.~      To demonstrate the superiority of this strategy in terms of survival, investigators would~     like to conduct a randomised comparative study of two strategies: 1) installation of an ECMO~     between the 20th minute to the 30 minute of CA, directly at the site of the CA, by emergency~     physicians and/or specifically trained resuscitators 2) On-site resuscitation optimised with~     secondary transfer to the hospital for the implementation of support. The purpose is to~     increase by 5% to 20% the survival of victims of out-of-hospital refractory cardiac arrests~     with a good neurological prognosis.~      Main objective:~      The hypothesis is that pre-hospital ECMO will result in survival for 20% of the patients,~     considering that the percentage of survival with in-hospital ECMO is less than 5%.~      Main judgement criterion:~      Survival with good neurological outcome (CPC 1 or 2) on discharge from intensive care or at 6~     months~      Secondary judgement criteria:~      Success rate of the implementation of ECMO ECMO implementation time Immediate complications:~     haemorrhage, infection Number of organ harvesting The quality of survivors' neurological~     status according to the CPC neurological classification at D 28, 2 months and 1 year~     Predictive indicators of the prognosis during cardiac arrest via cerebral and biological~     monitoring Methodology, type of study: This is a prospective randomised study of current care~     Sample size (SS, power, risk): A total number of 105 patients in each group will make it~     possible to demonstrate at the alpha risk of 5% and a power of 1-β=90%, a significant~     difference in favour of early pre-hospital ECMO compared to the current practice with~     in-hospital ECMO.~   "
79449|NCT02527018|"~     Primary Endpoint: Quantify the hemodynamic changes in preeclampsia using the non-invasive~     Nexfin device.~      Secondary Endpoint: Determine if measurable hemodynamic changes are statistically correlated~     with B-type natriuretic peptide (BNP) levels.~   "
79450|NCT02527005|"~     Randomized controlled single blind prospective comparative study~   "
79451|NCT02526992|"~     Rheumatoid arthritis (RA) is the most common chronic inflammatory joint disease in adults and~     is characterized by chronic inflammation of the joints leading to their destruction,~     resulting in a major loss of function.~      The investigators propose a pilot study for studying changes in bone microarchitecture with~     High Resolution peripheral micro Computerized Tomography (HR-pQCT) in patients with RA~     treated with anti-TNF(Tumor Necrosis Factor), with the measurement of micro-architectural~     parameters in subchondral area near an inflammatory joint during the first 12 months of~     initiation of an anti-TNF therapy (Infliximab®, Etanercept®, Adalimumab®).~   "
79452|NCT02526979|"~     The purpose of the study is to evaluate the pharmacokinetics (PK) of mirabegron oral~     suspension after single dose administration in children with neurogenic detrusor overactivity~     (NDO) or overactive bladder (OAB).~      This study will also evaluate the safety and tolerability as well as the acceptability and~     palatability of mirabegron oral suspension after single dose administration in children with~     NDO or OAB.~   "
79453|NCT02526966|"~     The anti-hinge region antibodies would be a relevant biomarker of IgA nephropathy. Beyond a~     prognostic value (which could increase the risk of Renal Absolute), the longitudinal~     monitoring for these antibodies could be of interest: (1) in the monitoring of patients (in~     place including a possible repetition renal biopsy); (2) to guide treatment decisions and (3)~     in clinical research, as an outcome (in substitution for the occurrence of kidney failure) in~     therapeutic trials IgA nephropathy.~      This research project constitutes the first step in validating these antibodies biomarker of~     IgA nephropathy and its main objective is to study the performance of the blood levels of~     anti-hinge region antibodies in the diagnosis of progressive forms of histologically IgA~     nephropathy as defined by the Renal Risk Absolute.~      The secondary objectives of this project are to establish a bio-collection that will allow us~     to search for other prognostic factors (genetic, cellular and serum) of IgA nephropathy and~     to evaluate the performance of Renal Absolute risk by integrating Oxford score, the new~     international histological classification.~   "
95302|NCT02319720|"~     Management of chronic wounds with:~        1. Bone Marrow Aspirate Plus Cultured Cells Group~        2. Cultured Cells Alone Group~        3. Bone Marrow Aspirate Alone Group~        4. Control Group~   "
79454|NCT02526953|"~     The purpose of this study is to determine whether the combination of paclitaxel,~     capecitabine, mitomycin and intensity-modulated radiotherapy is more effective than the~     standard combination of capecitabine, mitomycin and intensity-modulated radiotherapy (IMRT)~     in patients with squamous-cell anal cancer.~   "
79455|NCT02526940|"~     Although combined antiretroviral therapy (cART) has dramatically improved quality of life and~     lifespan of HIV infected individuals, it still fails to eliminate viral reservoirs. The Gut~     Associated Lymphoid Tissue (GALT) is the largest reservoir of HIV-1, as it harbors most of~     HIV target cells as activated memory Cluster of differentiation (CD)4+/CCR5+ T cells.~     Intestinal T and B cells express α4β7 integrin, a gut mucosal homing receptor which binds to~     gp120 HIV-1 envelope facilitating the infection of intestinal T cells and the early~     establishment of the gut HIV reservoir. Intensive viral replication in the GALT leads to an~     early impairment of mucosal immunity, due to the severe CD4+ T cells depletion, that could be~     also explained by a lack of recruitment in the gut. Among T cells, interleukin-(IL-)17~     secreting CD4+ T cells (Th17) are particularly depleted during HIV infection. This depletion~     could be associated with HIV progression since these cells play a crucial role in the~     maintenance of mucosal immunity. A dysbalance of the Th17/Treg ratio may reflect the loss of~     the intestinal epithelial barrier integrity. These damages are responsible for an increase in~     microbial translocation, which is associated with immune activation and progression to AIDS.~     Several recent studies have shown that cART initiation during acute or early HIV-1 infection~     reduces HIV DNA reservoir size and improves immune reconstitution in blood. Post-treatment~     controllers, who started long-term cART early after HIV infection, have very low levels of~     HIV DNA in peripheral blood mononuclear cells, similarly to elite controllers. Unlike most~     HIV-infected individuals, they maintain an undetectable plasmatic viral load after several~     years of cART interruption, suggesting that a weak reservoir is a prerequisite to achieve a~     functional cure. By extrapolation, it could be hypothesized that the gut viral reservoir is~     also decreased and that mucosal immunity is restored when cART is initiated during primary~     phase of infection. The gut viral reservoir begins to form within the first days after HIV~     exposure, and grows during acute HIV infection. Similarly, intestinal T cells are depleted~     very early after infection, due to high viral replication, host immune response and bystander~     effects. Most studies also concluded that long-term and optimal treatment can't fully restore~     mucosal immunity. These observations led us to study the impact of time of cART start on the~     size of viral reservoir and on immune reconstitution in the gut. For this, we analyzed the~     virological and immunological characteristics of the rectal HIV reservoir of long-term~     treated patients regarding their blood CD4+ T cells count at the time of cART initiation.~   "
79456|NCT02526927|"~     The occurrence of anorexia nervosa (AN) during childhood or adolescence rapidly induces~     starvation, stop of growth and impaired mineralization of bone tissue together with an~     interruption of pubertal development. These consequences are initially reversible following~     food intake return but can lead to a more irreversible status with low height, osteoporosis~     and high fracture risk. The onset of the disease more and more early in life, with the first~     stages of puberty suggest that these consequences will be even more severe as bone resistance~     will be damaged by more profound effects on bone growth as well. It is therefore critical to~     evaluate these bone metabolism alterations in order to better manage these patients.~      At every age and in every clinical circumstance either physiologic or pathologic, high~     resolution peripheral quantitative computerized tomography (HRpQCT) provides an evaluation of~     bone microarchitecture that is more informative than the global quantitative assessment given~     by conventional Dual Energy X-ray Absorptiometry) DEXA, with a better estimate of clinical~     fracture risk.~      Here, we propose to measure cortical parameters, such as cortical thickness which plays a key~     role in bone biomechanical strength in young adults aged between 20 and 30 years-old, who had~     developed AN as early as the during the first stages of puberty but no longer present,~     compared to age-and sex-matched healthy volunteers. Other micro-architectural parameters will~     also be studied. In an exploratory phase, we will evaluate these bone microarchitectural~     parameters together with bone biological turnover markers and markers of sexual maturation in~     adolescents or young adults 20 years-old or less, undernourished and currently managed for~     AN.~   "
79457|NCT02526914|"~     The purpose of this study is to investigate the role of a one-time intranasal administration~     of the oxytocin, vasopressin, or placebo on prosocial decision making such as cooperation and~     competition in a healthy population of student controls.~   "
79458|NCT02526901|"~     The Born in Guangzhou Cohort Study (BIGCS) was established to investigate the short- and~     long-term effects of exposure in early life on health consequences in Guangzhou, China. Data~     are collected regarding environmental, occupational and lifestyle exposures as well as health~     outcomes in later life. Biological samples including blood and tissue samples are also~     collected from the participants.~   "
79459|NCT02526888|"~     The main objective of this study is to investigate whether repeated administration of a~     cardiac medication (diltiazem) can affect the pharmacokinetics (i.e., amount and time of~     presence in the blood) of ACT-541468~   "
79460|NCT02526875|"~     To Evaluate the Efficacy of the Timing of the Administration of a Telmisartan/S-Amlodipine~     (Telminuvo®Tab. 40/2.5mg) on 24-hour BP Control in Hypertensive Patients Inadequately~     Controlled by Telmisartan Monotherapy~   "
79461|NCT02526862|"~     This study aims to test direct application of the Non-Invasive Mechanical Ventilation -NIVM-~     mask or interface as the most efficient intervention to prevent Pressure Ulcers (PU),~     compared with other three usual preventive measures which consist in the use of three~     different medical devices.~   "
79462|NCT02526849|"~     The purpose of this study is to evaluate the effect of fecal microbiota transplantation in~     adults with slow transit constipation.~   "
79463|NCT02526836|"~     The aim of this study is to compare between complete mesocolic excision with central vascular~     ligation and conventional surgery of colon cancer regarding number of harvested lymph nodes,~     surgical outcome and complications.~   "
79464|NCT02526823|"~     Anthracyclines were basic drugs in lymphoma treatment. However, their dose accumulation~     related cardiac toxicity limits their clinical application, especially adriamycin. Adriamycin~     has been gradually replaced by epirubicin. Polyethylene glycol liposome doxorubicin (PLD) can~     go into tumor tissues through tumor angiogenesis and produces targeted killing effect to~     tumor tissues. PLD has potential advantages in the treatment of malignant tumors,including~     lymphoma.~   "
79465|NCT02526810|"~     The purpose of this study is to compare the blood glucose control, glycaemic fluctuation and~     oxidative stress for Type 2 Diabetes between two therapies, one is glargine combined with~     oral drugs and the other is continuous subcutaneous insulin injection.~   "
79466|NCT02526797|"~     To investigate whether multiparametric MRI (mp-MRI) in patients with low-risk prostate cancer~     can improve the selection of patients suitable for Active Surveillance and have a relevance~     in the ongoing monitoring.~   "
79467|NCT02526784|"~     The purpose of this trial is to compare the severity of ISRs (Injection Site Reactions)~     following degarelix subcutaneous (s.c.) administrations with two different injection~     techniques and intramuscular (i.m.) administration in patients with hormone dependent~     prostate cancer.~   "
95303|NCT02319707|"~     To compare the efficacy of three different protocols of third stage management in preventing~     PPH.~   "
79469|NCT02526758|"~     Chronic obstructive pulmonary disease (COPD) is a common disease , and characterized by~     progressive development of airflow limitation. Small airway disease (obstructive bronchitis)~     and lung parenchyma damage (emphysema) are the main mechanisms of chronic airflow limitation.~     Research shows that small airway resistance increased by 4-40 times in COPD patients, and~     become the main part of the airflow obstruction. Impulse oscillation system (IOS) is able to~     measure the total airway resistance, the central airway resistance and the peripheral airway~     resistance, which is now widely used to assess small airway function in COPD patients. While~     High resolution CT (HRCT) is easy to operate and its images are intuitive. Meanwhile it can~     measure the proportion of emphysema, the airway diameter and the thickness of airway wall.~     Both of these two tests have great significance in small airway evaluation. Chronic~     obstructive pulmonary disease with acute exacerbation (AECOPD) is an acute onset process,~     which is characterized by the aggravation of respiratory symptoms and deterioration of~     pulmonary function. However, the structural and functional changes of small airway in AECOPD~     are not clear. Inhalation drugs are the main treatment for stable COPD , and inhaled~     corticosteroid（ICS）+long-acting beta2-agonist（LABA） are used to treat patients with severe~     and severe airflow limitation. The particles in traditional inhalation drugs are larger and~     mainly deposited in large airways, and their effects on small airway function are relatively~     small.~      The objectives of the investigators study are COPD patients. The study is divided into two~     parts, that is the part of AECOPD patients and the part of stable patients . Patients with~     AECOPD are arranged to take HRCT and IOS test to assess the small airway changes.Patients~     with stable COPD are randomized to take either beclomethasone / formoterol (particle diameter~     for 1.4-1.5um) or budesonide / formoterol (3.2um) for three months. The structure and~     function changes of small airway in different stage will be evaluated and the efficacy of~     these two drugs is to be compared. This study is expected to highlight the investigators~     understanding on the role of small airways in COPD, and provide a guideline to clinical~     standardized treatment as well as evaluation of patients' conditions.~   "
79470|NCT02526745|"~     This study evaluates the safety and immunogenicity of live attenuated vaccine in adults aged~     50 years and older. Half of participants will receive high doses of the vaccine,while the~     other half will receive low doses of the vaccine in phase I clinical trial. At the phase II~     clinical trial, participants will be distributed equally to four groups(low、middle, high~     doses of the vaccine and placebo).~   "
79471|NCT02526732|"~     The aim of the study is to examine the influence of hepatic inflammation or damage on~     physical performance (maximal oxygen uptake, VO2max) depending on the histologic state of the~     liver. The study population are patients with fatty liver disease and non-alcoholic~     steatohepatitis (NASH). All study participants obtain an individual training plan with~     individual and group training sessions for a period of 8 weeks. At the beginning and end of~     the training phase a sport physiological examination is carried out. In the study group the~     effect of regular examinations is surveyed by surrogate parameters of liver inflammation.~   "
79472|NCT02526719|"~     The goal of nipple-sparing mastectomy (NSM) with immediate breast reconstruction is to~     reconstruct a breast mound with preservation a patient's natural skin envelope. Preservation~     of the nipple and areola complex during mastectomy and breast reconstruction is associated~     with improved quality of life and a better cosmetic result. However, this surgical technique~     relies on tenuous blood supply to maintain the nipple and areola. Therefore a certain~     proportion of women will actually lose their preserved nipple-areolar complex due to vascular~     insufficiency. Furthermore, some women may find out after a nipple-sparing mastectomy that~     cancer had invaded the nipple-areolar complex, and would require another operation to~     completely remove the cancer. Despite these devastating complications, there have been no~     controlled studies to investigate mechanisms to reduce the chance of their occurrence.~      Our research study will use a pre-operative minor procedure to enhance blood flow to the~     nipple-areola complex prior to standard nipple sparing mastectomy among eligible women~     undergoing mastectomy for breast cancer or risk reduction. A secondary objective is to test~     how many women actually have active cancer in their nipple at the time of this minor surgical~     procedure, prior to standard NSM. The investigators hypothesize that our innovative and novel~     nipple-delay procedure will reduce the risk of loss of the nipple due to vascular~     insufficiency and may be of benefit to identify the small proportion of women with~     nipple-areola complex involvement, in order to optimize the ultimate cancer ablation.~      For this study the investigators propose to undertake a Pilot RCT as the first step in the~     evaluation of a delay procedure prior to NSM, and the results will be used to determine the~     feasibility and inform the optimal design for a definitive RCT. This study question has the~     potential to set a new standard of care in the management of women seeking NSM for the~     management of their breast cancer.~   "
79473|NCT02526706|"~     The investigators aim to conduct a prospective clinical pilot study to investigate the use of~     VisionBlue staining administered during cataract surgery to 20 patients with history of~     trabeculectomy for glaucoma as a means to assess functioning of an existing filtering bleb.~     The investigators also aim to develop a standard classification system for assessing~     filtering bleb function during cataract surgery.~   "
79474|NCT02526693|"~     The Konan RAPDx (Konan Medical USA, Irvine, CA) is a newly patented pupillography device.The~     aims of this study are to assess the ability of the RAPDx to distinguish between healthy~     subjects and patients with confirmed glaucoma using standard testing sequences, assess the~     ability of the RAPDx to distinguish between healthy subjects and patients with confirmed~     glaucoma using a customized testing sequence developed for use at the Wills Eye Hospital~     Glaucoma Research Center and to determine the combination of demographic, clinical, and RAPDx~     testing parameters which allow for maximum sensitivity and specificity in discriminating~     healthy subjects from those with glaucoma.~   "
79475|NCT02526680|"~     To determine the impact of OrCam on health-related quality of life (HRQoL) in subjects with~     advanced glaucoma over 1 month and to assess health-related quality of life using the~     National Eye Institute Visual Functioning Questionnaire 25 (NEI-VFQ-25).~      To determine the tasks for which the subjects are using the OrCam device and patient~     satisfaction and to analyze qualitative data from weekly patient logs, in order to determine~     efficacy of OrCam.~   "
79476|NCT02526667|"~     Demonstrate the reduction of bacteria on the skin.~   "
79477|NCT02526654|"~     The main purpose of this study is to compare standard automated perimetry (SAP) using the~     Heidelberg Edge Perimeter (HEP) with the Octopus Visual Field (OVF) analyzer and determine~     test-retest reliability of both parameters in detecting glaucomatous visual field losses. A~     secondary outcome measure is investigation of novel imaging parameters of the optic nerve~     head and a new automated structure-function report.~   "
79478|NCT02526641|"~     Investigation of the effects of the new Abbvie direct acting anti-viral (DAA) treatment of~     chronic viral hepatitis C infection on the macrophage specific activation marker soluble~     CD163, portal hypertension determined by the hepatic venous pressure gradient (HVPG), and~     metabolic liver function determined by the galactose elimination capacity (GEC) test and the~     functional hepatic nitrogen clearance (FHNC).~   "
79479|NCT02526628|"~     The haemostatic balance and neurocognitive capability of men with Klinefelter syndrome is~     compared to healthy controls by using specific biochemical assays for coagulation and~     fibrinolysis and a selection of neuropsychological tests and brain fMRI. Furthermore, the~     effect of gonadal status and any effects of long- or short-term testosterone treatment on the~     above mentioned parameters are investigated.~   "
79507|NCT02526264|"~     Patients with colorectal cancer prior to stoma surgery are randomized to different~     preoperative education programs: (a) specific preoperative education, (b) standard~     preoperative education. Outcome measures are quality of life, period of hospitalization and~     complication rates.~   "
79480|NCT02526615|"~     The objectives of this study are to compare the effects of rosiglitazone and metformin on~     insulin stimulated glucose uptake in subjects with type 2 diabetes. Whole body, and skeletal~     muscle, heart and adipose tissue insulin stimulated glucose uptake is measured during~     euglycemic hyperinsulinemic clamp and positron-emission tomography scanning before and 26~     weeks after treatment in 48 newly diagnosed subjects with type 2 diabetes. Subjects will be~     randomized to receive either rosiglitazone or metformin or placebo, according to a simple~     randomization procedure with double blinding.~   "
79481|NCT02526602|"~     Urinary incontinence and impotence are typical disturbances after radical prostatectomy.~     Although, several surgical methods are developed to decrease these disturbances, 8% and 50%~     of the patients suffer from permanent urinary incontinence and impotence, respectively.~      Previously two studies have shown that endopelvic fascia preservation may decrease~     postoperative incontinence and impotence rates. Unfortunately these studies are retrospective~     decreasing their reliability.~      The present study is prospective and randomized clinical trial. The investigators are going~     to randomize 180 patient to preservation and opening the endopelvic fascia groups. Functional~     and oncological results are followed up to 1 year after surgery.~   "
79482|NCT02526589|"~     Traditionally the watertightness of urethrovesical anastomosis after robotic radical~     prostatectomy is controlled by cystogram. However, clinical observations and one previous~     study showed that patients with anastomotic leakage have red coloured urine. If the~     investigators can verify this finding, the most of the cystograms can be avoided. In this~     study the investigators estimate urine colour after cystogram and take a picture from urine~     collecting pag. Later on the pictures are digitally analyzed and compared to cystogram~     finding.~   "
79483|NCT02526576|"~     This phase two, randomized, double-blind study is designed to demonstrate the enhanced~     efficacy of SVF-enriched autologous facial fat grafts, in relation to standard, non-SVF~     enriched, facial fat grafts by evaluating volumetric retention and contour of the engrafted~     region over the course of one year.~   "
79484|NCT02526563|"~     The primary investigators in this study plan to investigate serum concentrations of~     ropivacaine in pediatric patients who already receive as standard of care a continuous wound~     catheter after an iliac crest alveolar bone graft harvest for completion of a previous cleft~     palate repair.~      The goals of this study are 1) to determine serum concentrations (free, unbound) of~     ropivacaine 2) To evaluate pain scores during the perioperative period to determine efficacy~     of wound catheters for postoperative analgesia for iliac crest bone graft harvest.~   "
79485|NCT02526550|"~     This study was undertaken to assess the immunogenicity and safety of a booster dose of a live~     attenuated chimeric Japanese Encephalitis vaccine (JE-CV) after primary vaccination with~     SA14-14-2 in Thai children aged 1 to <5 years. In addition, to assess the impact of the~     duration interval after primary vaccination on subsequent booster response.~   "
79486|NCT02526537|"~     Currently, whether adjuvant therapy should be applied to Stage Ib non-small cell lung cancer~     (NSCLC) patients who received radical resection remains controversial. There is still no~     clear evidence that the postoperative adjuvant chemotherapy or other treatments can improve~     the survival rate for patients with stage Ib NSCLC. Tyrosine Kinase Inhibitors (TKIs) such as~     Gefitinib and Erlotinib are widely accepted as the first-line therapy for Epidermal growth~     factor receptor (EGFR) gene mutation late stage NSCLC patients. However the effect is largely~     uncertain for early stage patients who received surgery. The investigators aim to evaluate~     the effect of postoperative adjuvant use of Gefitinib for high risk stage Ib EGFR sensitive~     mutation NSCLC patients.~   "
79487|NCT02526524|"~     The purpose of the study is to compare the glycemic effects of delayed-release metformin (Met~     DR) to placebo in subjects with type 2 diabetes mellitus (T2DM) over 16 weeks. The study is~     designed to evaluate several doses of Met DR (600 to 1500 mg once daily in the morning [qAM])~     compared to placebo. A single-blind reference treatment of 2000 mg metformin~     immediate-release (Met IR) per day administered as equal divided doses (1000 mg Met IR BID)~     will also be included.~   "
79488|NCT02526511|"~     This pilot clinical trial studies perfusion magnetic resonance imaging in diagnosing patients~     with kidney tumors. Diagnostic procedures, such as perfusion magnetic resonance imaging, may~     help find and diagnose kidney tumors and predict and monitor a patient's response to~     treatment.~   "
79489|NCT02526498|"~     This phase II trial studies how well accelerated partial breast irradiation (APBI) using~     high-dose rate (HDR) brachytherapy works in treating patients with breast cancer that has not~     spread beyond the breast or the axillary lymph nodes (early-stage) after surgery. Radiation~     therapy uses a type of energy to kill cancer cells and shrink tumors. Brachytherapy is a type~     of internal radiation therapy that provides radiation inside the breast to any remaining~     tumor cells next to the space where the tumor was removed, and is given over a shorter amount~     of time than standard radiation therapy. Giving accelerated partial breast irradiation (APBI)~     using high-dose rate (HDR) brachytherapy may reduce the overall time that radiation is~     delivered to the tumor cells.~   "
79490|NCT02526485|"~     The purpose of this research is to identify genomic markers that can predict heparin-induced~     thrombocytopenia (HIT), which is a very serious side effect to heparin. Heparin is commonly~     used to prevent blood clots and the investigators may be able to identify genomic markers~     which can be used to prevent heparin use in people who will get HIT.~   "
79491|NCT02526472|"~     One thousand, six hundred forty-eight IVF patients undergoing ET with fresh embryos,~     randomized to receive mTVET (n=828) or UGET (n=820). The transfer in uteri of 1-2 embryos on~     day 2-3 of culture was performed using a soft catheter either under trans-abdominal US~     guidance (UGET group) or after measurement of uterine cavity by transvaginal US and~     calculation of the discharge site (mTVET). Mai outcome measures was the clinical pregnancy~     rate (CPR), secondary outcomes were the implantation rate (IR), and the patient's discomfort~     during ET procedure.~   "
79492|NCT02526459|"~     The study design is a prospective, single institution, randomized control trial in which the~     introduction of a birth plan is the intervention and a comparison of the rate of Caesarean~     sections between participants in the control group (no birth plan) and the experimental group~     (birth plan) is the primary outcome.~   "
79493|NCT02526446|"~     This proposed study is to evaluate the effectiveness of a self-administered acupressure~     intervention on caregiver stress and associated distress symptoms of fatigue, insomnia and~     depression in Chinese family caregivers of an elderly family member.~   "
79494|NCT02526433|"~     Post-natal depression (PND) is anticipated to affect 12.9% of new mothers with at least~     75,000 cases per year in the UK alone. However, despite this, there is currently a worrying~     lack of support for new mothers, with data suggesting that 64% of healthcare trusts in the UK~     do not have a strategy for treating PND, and flaws in the current pharmacological and~     psychological treatment models. Consequently, research into promising psychosocial~     interventions such as music is critical to developing new paradigms for treating PND.~      This project is an ambitious programme of research that investigates links between the mental~     health of women in the later stages of pregnancy and first 9 months post birth and their use~     of psychosocial interventions including music.~   "
79495|NCT02526420|"~     A Phase 2, open-label dose-finding safety study of individualized monthly VRS-317 dosing for~     five months in adults with GHD.~   "
79496|NCT02526407|"~     Post-natal depression (PND) is anticipated to affect 12.9% of new mothers with at least~     75,000 cases per year in the UK alone. However, despite this, there is currently a worrying~     lack of support for new mothers, with data suggesting that 64% of healthcare trusts in the UK~     do not have a strategy for treating postnatal depression, and flaws in the current~     pharmacological and psychological treatment models. Consequently, research into promising~     psychosocial interventions such as music is critical to developing new paradigms for treating~     postnatal depression.~      This project is an ambitious programme of research that investigates the effects of music on~     postnatal depression through two phases: a questionnaire study and an intervention study.~     This record is for the intervention study. The questionnaire study has a separate record. We~     are accepting host hospital sites for both.~   "
79497|NCT02526394|"~     The trial includes groups receiving various combinations of meningitis C and pertussis~     containing vaccines, to be administered concomitantly in adolescents due their school leaving~     booster vaccinations (as per UK routine immunisation schedule at 13-17 years of age).~     Immunogenicity and reactogenicity will be assessed.~   "
79498|NCT02526381|"~     Clinical study on patients with turbid phlegm and blood stasis syndrome and Qi -Yin~     Deficiency syndrome of coronary artery disease (CHD) compared with normal cases will be~     launched. Detection of lipid metabolism, inflammation medium, endothelial cell injury, blood~     coagulation function evaluation of the relationship between disease and biochemical basis,~     detect plasma metabonomics and the gene expression profile chip, with phlegm - lipid~     metabolic disorder, stasis - microcirculation disorder, alternating knot - inflammation~     mediated and other system related to the biological basis. With Danlou Tablet for treatment,~     the investigators can observe result/effect index of turbid phlegm and blood stasis syndrome.~     Through comprehensive comparison of multi-level, multi-targets and multi-date biological~     index to discuss its sickness-syndrome-prescription corresponding relation and its biological~     basis.~   "
79499|NCT02526368|"~     This is a pilot study evaluating pre-surgical patients with histologically confirmed~     localized prostate cancer who receive infusion with hyperpolarized pyruvate (13C) injection~     and undergo metabolic MR imaging with endorectal coil within 12 weeks of subsequent radical~     prostatectomy.~   "
79500|NCT02526355|"~     The prevalence rate of maternal depression in Pakistani women and its effect on the growth~     and development of young children and child mortality is very high.~      The main objective of this study is to increase access to evidence based psychological~     interventions for mothers who have children of age 0 to 30 months, consistent with her~     values. The study will be a 2 (conditions) into 3 (Time) single blind randomized controlled~     trail. Depressed mothers will be randomized either to intervention arm or control arm.~     Intervention will include text messages based on Learning Through Play Plus (LTP plus CBT).~   "
79501|NCT02526342|"~     Aim of the study is to prove the utility and safety of the negative pressure wound therapy~     (NPWT) in the postoperative management of free flaps.~      The quantitative assessment of the entirety of clinical main relevant parameters like edema~     formation, microcirculation, macrocirculation and wound healing should create a better and~     comprehensive understanding of the NPWT effects in this field.~   "
79502|NCT02526329|"~     This phase I trial studies the side effects and best dose of donor regulatory T cells in~     treating patients with graft-versus-host disease affecting the liver or gastrointestinal~     organs (visceral) within 100 days (acute) after undergoing a stem cell transplant.~     Graft-versus-host disease occurs when donor immune cells infused in a stem cell transplant~     attack the gut, skin, liver, or other organ systems of the patient. Regulatory T cells are a~     type of immune cell that may be able to reduce the attack of the donor's immune cells on the~     patient's normal cells and help treat graft-vs-host disease.~   "
79503|NCT02526316|"~     The study will include 10 patients with HPV-associated ano-genital cancer (cervical, vulvar,~     vaginal, penile, anal) or HPV-associated head and neck cancer, who are planned to receive a~     cisplatin-based chemotherapy (alternatively a carboplatin-based chemotherapy may be selected~     by investigators choice). Patients will receive P16_37-63 peptide (100 µg) combined with~     Montanide® ISA-51 VG subcutaneously once a week for four weeks, followed by a 4 week rest~     period (1 cycle). The vaccination is to be started one week before the initiation or~     continuation of the cisplatin-based chemotherapy. Concurrent radiation is allowed and should~     be documented. The vaccination schedule will be repeated up to a total of 3 cycles (= 6~     months) or until progression or intolerable toxicity. If chemotherapy is withheld (e.g. for~     toxicity), vaccination treatment can be continued.~   "
79504|NCT02526303|"~     The purpose of this study is to determine the safety and efficacy of anticoagulation in the~     treatment of non-occlusive portal vein thrombosis in patients with liver cirrhosis.~   "
79505|NCT02526290|"~     In this study, the safety and effectiveness of the Oculeve Intranasal Lacrimal~     Neurostimulator after 180 days of use in participants with aqueous tear deficiency will be~     evaluated.~   "
79506|NCT02526277|"~     The purpose of this study is to assess whether the MMF07 Foot Massager and/ or heat therapy~     may improve symptoms of restless legs syndrome (RLS). It will also assess the effect of the~     MMF07 Foot Massager and/ or heat on quality of life and sleep in people affected by RLS.~     Participants will be randomly assigned to one of four treatment groups;~        1. MMF07 Foot Massager device~        2. Heat therapy~        3. Heat therapy and the MMF07 Foot Massage device~        4. Neither heat nor MMF07 Foot Massager device (no treatment group)~   "
79599|NCT02525055|"~     The investigators conducted an initial safety and characterisation study in healthy adult~     volunteers, utilising a unique clinical quarantine facility in London, UK.~   "
79508|NCT02526251|"~     The purpose of this cohort study is to map, during one year in an e-health setting, patients~     having Inflammatory Bowel Disease (IBD) with mild to moderate activity in relation to~     dysbiosis (gut bacteria) and inflammation burden measured by disease activity questionnaires~     (HBI and SCCAI) and Fecal Calprotectin (FC) on any smart phone. And Secondarily how dysbiosis~     defined by a dysbiosis index (DI) ranging from 1-5 is related to changes in disease activity~     and FC under different treatments scenarios. Is a certain DI or specific bacteria probes~     related to increase or reduced relapse rate. Moreover change in above mentioned~     parameters/indices will also be correlated to QoL and a fatigue score.~   "
79509|NCT02526238|"~     This is a double blinded, randomized control trial with a pretest-posttest control and~     interventional group design. The assessor is blinded to all assessments and evaluations. All~     patients with subacute stroke undergo in-patient or out-patient rehabilitation are screened~     initially by a series of screening test. Suitable patients are assigned randomly to two~     groups respectively. Group 1 is the experimental group for Transcranial Magnetic Stimulation~     (TMS) and trunk rotation; Group 2 is the control group with only trunk rotation training and~     placebo stimulation.~   "
79510|NCT02526225|"~     The aim of this study is to evaluate the safety and effectivity of Ginkgo diterpene lactone~     meglumine injection tn the treatment of acute ischemic stroke~   "
79511|NCT02526212|"~     The primary goal of this research is to improve the effectiveness of buprenorphine~     maintenance treatment (BMT) within primary care.~      Investigators propose that providing BMT as part of a group medical visit (instead of an~     individual visit) will improve treatment outcomes for patients with persistent opioid abuse,~     because members become accountable to the group, are exposed to beneficial habits of others~     (i.e. positive deviance), and can receive efficacious behavioral interventions concomitantly~     with medical management~   "
79512|NCT02526199|"~     To extend the duration of peripheral nerve blockade after major foot and ankle surgery the~     investigators randomize the postoperative treatment with either perineurial sciatic nerve~     blocks with 0.5% Bupivacaine-Epinephrine with or without Dexamethasone.~   "
79513|NCT02526186|"~     We will conduct a randomized controlled trial to determine whether the addition of~     battlefield auricular acupuncture to standard of care is effective for control of postpartum~     pain for mothers in the immediate post-partum period. Post-partum patients (DoD~     beneficiaries) 18 years or older, regardless of gravida/parity, who plan to have a childbirth~     in a hospital setting will be offered the opportunity to participate in the study through PCM~     referrals and posted advertisements. After a minimum of 6 hours post-vaginal delivery or 24~     hours post caesarean section subjects will be given treatment according to their~     randomization group. Subjects will be assessed on pain control, overall satisfaction with~     pain management, and the amount of pharmacological pain medications used. Safety of measures~     will also be assessed to include infection rates, syncope, vertigo, and hypotension.~   "
79514|NCT02526173|"~     The investigators will examine the beneficial impacts of applying of dHACM on the preserved~     neurovascular bundles (cavernosal nerves) and the prostate bed during robotic assisted~     laparoscopic prostatectomy. Such application can result in promotion of soft tissue healing~     and reduction of inflammation at the operative site and thus an acceleration of return of~     potency regulating cavernosal nerves.~   "
79515|NCT02526160|"~     The primary efficacy objective of this study is to establish the effect of KRN23 treatment~     compared with placebo on increasing serum phosphorus levels in adults with XLH.~   "
79516|NCT02526147|"~     This evaluation is part of a five country project to evaluate the benefits and costs of the~     use of two alternatives to food transfers: vouchers and cash (hereafter referred to as~     alternative modalities). The project will generate information on how outcomes such as~     household food expenditure and dietary diversity, relevant to both beneficiaries and WFP,~     change following the introduction of these alternative modalities; how benefits and costs of~     these are, relative to food transfers, distributed across and within households; and what are~     the critical operational issues that need to be addressed for these alternatives to be~     successfully implemented. More specifically, the project will answer seven questions:~        1. Do households benefit from receipt of the alternative modalities?~        2. Are these benefits greater, or less, when transfers are made using alternative~          modalities compared to food transfers. How does this vary across outcomes (such as~          nutrition, livelihoods, gender dynamics and intra-household resource allocation) that~          are of especial interest to WFP?~        3. How does the distribution of benefits differ across households when transfers are made~          using alternative modalities compared to food transfers?~        4. How does the distribution of benefits differ within households when transfers are made~          using alternative modalities compared to food transfers? Do certain household members~          (women, young children) benefit more from one type of modality? How do these modalities~          affect decision-making processes within the household?~        5. Why are these differences observed? How do the reasons for these differences affect the~          study's ability to generalize from these evaluations?~        6. Does the delivery of alternative modalities cost less than food transfers? What accounts~          for these cost differences? Are some costs (such as transport) really lower or are they~          transferred to beneficiaries? Within the household, who bears these additional costs?~        7. What is the benefit: cost ratios associated with these different modalities from the~          perspective of WFP? Is there a conflict between the modality preferred by WFP and the~          modality preferred by beneficiaries?~      These objectives will be accomplished through household survey data collection among a panel~     of households before and after transfer of alternative modalities. In addition, select~     countries will involve the collection of anthropometric, biomarker and cognitive testing.~   "
79517|NCT02526134|"~     The purpose of this study is to estimate the rate of patients in whom a significant change in~     the area to be irradiated will be observed between the assessment before and after laying the~     evaluation of Trustees.~   "
79518|NCT02526121|"~     The purpose of this study is to evaluate the effect of iron depletion with phlebotomies on~     blood triglyceride concentration, in subjects with hypertriglyceridemia and iron overload,~     compared with a dietary intervention alone.~      All subjects in this study will follow dietary and lifestyle counseling in a period of 3~     months.~      A randomized group will receive phlebotomies every 3 weeks in this period.~   "
79519|NCT02526108|"~     The purpose of this study is to assess the energy expenditure and intensity of a High~     Intensity Functional Training (HIFT) session in overweight and obese adult men and women.~   "
79520|NCT02526095|"~     This retrospective study aims at evaluating the outcomes of gastrointestinal stromal tumor~     after surgery.~   "
79521|NCT02526082|"~     The Helsinki Businessmen Study (HBS) is a clinico-epidemiological longitudinal study started~     in 1964. It also included a 5-year randomized, controlled multifactorial primary prevention~     trial of cardiovascular diseases between 1974-1980. The cohort is being actively followed-up~     through national registers since the 1980, and since 2000 with regular questionnaire surveys.~     Latest in 2015. Also clinical and laboratory studies have been performed in random~     subcohorts. Follow-up is ongoing with new hypothesis-generating research questions.~   "
79695|NCT02523794|"~     The purpose of this study is to evaluate the efficacy of electro-kinetically modified water~     (EMW) beverage, consumed twice daily (BID) for 3 months in the management of endometriosis~     associated pain, and to evaluate the effect of EMW consumption on analgesic use for~     endometriosis associated pain.~   "
79522|NCT02526069|"~     Study Objectives:~      This study aims to assess the feasibility and acceptability of an application utilising~     Acceptance and Commitment Therapy in young people with type 1 diabetes.~      Primary Research Questions:~      Is an ACT based application feasible and acceptable to young people with type 1 diabetes.~      Study Design:~      Patients will use the app for four weeks and then be invited to attend an interview~     discussing the acceptability, usability and feasibility of the app. Clinician's will also be~     invited to take part in a workshop where they interact with the app and provide feedback.~      Consent for will be obtained through the app. Additional consent for the recording of~     interviews will be obtained in paper format and stored in a secure locked cabinet at~     Edinburgh University.~      Quantitative data will also be collected on well-being, psychological flexibility, and data~     usage.~      Data Collection~      Qualitative feedback:~      Interviews will be recorded and transcribed using unique identifiers.~      Outcome measures and data usage patterns:~      Data will be collected on a password protected database which can only be obtained via a~     password protected and encrypted server from University of Edinburgh.~      Data Analysis:~      Phase 1:~      Framework analysis and interpretive phenomenological analysis will be utilised to create~     themes from the qualitative feedback.~   "
79523|NCT02526056|"~     This study is a usability design with qualitative and quantitative aspects. In one part, with~     patients, physical strain and designs facets will be investigated and in another part with~     physiotherapists, the therapeutic relevance and design features will be explored.~      For this reasons 13-15 elderly people have to play an exergame, during their game playing~     process, different measurements will be done. Additional 13-15 physiotherapists will also~     playing the exergame, they will be asked about their opinions about the game.~   "
79524|NCT02526043|"~     The purpose of the study is to observe the curative effect and safety of laparoscopic versus~     open liver resection for hepatocellular carcinoma.~   "
79525|NCT02526030|"~     The selection of antipsychotic in early stages of the illness is mainly determined by its~     clinical effectiveness. Second generation antipsychotics (SGAs) are the first line drug~     treatment for individuals suffering from schizophrenia. It is clear that SGAs are not a~     homogeneous group and clinical effects and profile of side effects differ between SGAs.~     Differences among antipsychotics in terms of effectiveness have turned out to be a topic of~     increasing research interest, although comparisons between the different SGAs are scarce. In~     first episode of psychosis, SGAs have shown a higher treatment effectiveness compared to~     first generation antipsychotics (FGAs) (findings primarily driven by Haloperidol). Less~     evident seems to be the notion that some of the SGAs might be more effective (in terms of~     treatment discontinuation) than others. Most of the medium-term randomized studies have shown~     similar rates of all-cause treatment discontinuation in first episode patients treated with~     different SGAs. It may be concluded that more randomized controlled trails should be~     accomplished to determine the position of frequently used SGAs in clinical practice.~     Investigators undertook this study with the major objective of comparing the clinical~     effectiveness of three widely utilized SGAs (Aripiprazole, Ziprasidone and Quetiapine) in the~     acute treatment of first-episode non-affective psychosis individuals at 3 years of follow-up.~   "
79526|NCT02526017|"~     This is a phase 1a/b single-arm, open-label study to evaluate safety, tolerability, PK, and~     clinical benefit of Cabiralizumab in combination with nivolumab in patients with selected~     advanced cancers.~   "
79527|NCT02526004|"~     Antimicrobial resistance is a significant challenge facing global healthcare. The unnecessary~     use of antibiotics is a key driver in the development of antibiotic resistance. Cystic~     Fibrosis (CF) represents a unique disease model to study bacterial resistance and to explore~     therapeutic strategies for same, as chronic lung infection overlaps with acute lung~     exacerbation's caused by a multitude of organisms. With time, chronic polymicrobial infection~     develops, with the most dominant infecting organism being Pseudomonas aeruginosa. In acute CF~     infections, empiric intravenous antibiotics are usually given for two weeks. Recurrent~     infections and treatments result in increasing antimicrobial resistance, and alterations in~     pathogen host interactions in the lung and gut flora. Next-generation DNA sequencing~     technology now offers DNA-based personalised diagnostics and treatment strategies. Enhancing~     our knowledge of the microbiome allows the use of stratified targeted antibacterial therapy~     that can be compared with standard empirical antibacterial therapy currently used. Cystic~     Fibrosis Microbiome-determined Antimicrobial Therapy Trial in Exacerbations: Results~     Stratified (CFMATTERS) will provide a randomized multi-centre controlled trial of~     microbiome-derived antimicrobial treatments versus current empirical therapy.~   "
79528|NCT02525991|"~     Phase IV, multinational, multicentre, open-label, non-randomized, clinical trial conducted in~     Europe (Spain, Germany, Finland, Norway, Romania and Austria) to evaluate the safety profile~     of ADASUVE® in agitated patients with schizophrenia or bipolar disorder when~     self-administered outside of a hospital setting without the supervision of a healthcare~     professional. The Study will aim to include approximately 500 patients who have been~     previously treated with ADASUVE® in the last 6 months prior to screening or recently treated~     during the planned recruitment period of 6 months with a 'positive outcome' ('ADASUVE®~     responder') according to Clinical Global Impressions (CGI-I) scale, from a total of about~     30-34 centers. All patients will be followed up for a maximum of 6 months from baseline,~     during which it is expected that a new episode of agitation will occur.~   "
79529|NCT02525978|"~     The purpose of this study is to understand if there is a relationship between the way that~     emotions are regulated by the brain and the way that heart rate is regulated by the brain.~     The study also seeks to understand whether having depression changes the way that emotions~     and heart rate are regulated.~   "
79530|NCT02525965|"~     Before the surgery, the investigators predict the risk of microvascular invasion (MVI)~     presence for the early-stage hepatocellular carcinoma according to the nomogram the~     investigators have created. Patients with a high risk of microvascular invasion were randomly~     chose to give the treatment of a wide resection margin, which establish an individualized~     anti-recurrence program based on the high-grade evidence-based medicine.~   "
79531|NCT02525952|"~     The aim of this study is to establish a selection criteria of hepatectomy for patients with~     multiple hepatocellular carcinomas based on the NDR Scoring System~   "
82600|NCT02485769|"~     A Phase 1, Randomized, Double Blind, Sponsor Open, Placebo Controlled, Sequential Group,~     Multiple Ascending Dose Escalation Study To Evaluate The Safety, Tolerability, And~     Pharmacokinetics Of Orally Administered PF-06650833 In Healthy Subjects~   "
79532|NCT02525939|"~     A placebo-controlled, randomized, double-blind, parallel group, phase III multicenter study~     in subjects recently hospitalized for ACS and with the appropriate genetic profile. Subjects~     will provide informed consent before any study-specific procedures are performed. Subject~     enrollment may begin in the hospital and will continue following release from the hospital.~     Screening procedures may be performed at the time of the index ACS event or anytime~     thereafter, with the condition that randomization must occur within the mandated window (4-12~     weeks after the index event). Subjects will be assessed based on their medical history. Those~     who are likely to qualify will undergo Genotype Assay testing to evaluate genetic~     determination for the presence of AA genotype.~   "
79533|NCT02525926|"~     Pulmonary hypertension is a rare condition that leads to right ventricular dysfunction and~     premature death. Only modest improvements of outcomes have been observed with the current~     available advanced specific drug therapy. Pulmonary hypertension advanced therapy is also~     expensive and leads to frequent adverse effects, sometimes serious. Results from a pilot~     study, the first-in-man experience of pulmonary artery denervation, demonstrated a clinical~     improvement in 13 patients with severe pulmonary hypertension despite optimal medical~     management. However this single non-randomized study requires confirmation.~      The investigators propose a prospective multi-center, randomized, single-blinded trial. Its~     main objective will be to assess, in patients with uncontrolled pulmonary hypertension~     despite optimal medical management, the efficacy of pulmonary artery denervation in reducing~     mean pulmonary artery pressure (mPAP) at six months, compared to continued medical treatment~     following a simulated (sham) procedure.~      The principal evaluation criteria will be the mPAP change (in mm Hg) as measured by right~     heart catheterization.~      The study will run for 18 months and it will be necessary to recruit 50 patients.~      All adult patients (with the exception of pregnant women and individuals unable to receive an~     appropriate information and to give their free and informed consent) with uncontrolled~     pulmonary arterial hypertension despite optimal medical management will be invited to~     participate, in the absence of any exclusion criteria.~      The investigators will also measure changes in clinical, biological, echocardiographic and~     hemodynamic prognostic markers in both groups.~   "
79534|NCT02525913|"~     The purpose of this study is to build a device that will consistently ablate (destroy or~     remove) cavitary breast tissue after a formal breast cancer resection in order to mimic the~     tissue that is now irradiated after breast cancer lumpectomy. The device would be easier to~     handle, perform the ablation in less time and by so ablating this margin would avoid the need~     in many for reoperation to obtain negative margins and based on preliminary data avoid the~     need for radiation. This would be especially important in poor and rural patients and would~     lead to decreased costs of treatment in patients with favorable breast cancer.~   "
79535|NCT02525900|"~     Prospective, randomized study comparing local wound infiltration with local anesthetic (LA)~     versus single injection TAP blocks (ssTAP) with LA versus continuous TAP block (TAP caths)~     catheters with LA for treatment of postoperative pain after total abdominal hysterectomy~     (TAH).~   "
79536|NCT02525887|"~     This observation will look at patient care decisions of the primary healthcare provider~     utilizing the results of the DNA testing of patients' metabolic pathways using 2C19, 2C9,~     2D6, 3A4, Factor II, Factor V and MTHFR and VKORC1. Findings of the data collection will be~     published to optimize the benefits of pharmacogenomics testing and publish health outcomes.~   "
79537|NCT02525874|"~     The primary objective of the study is to evaluate the effect of BG00012 on lymphocyte subset~     counts during the first year of treatment in subjects with relapsing-remitting multiple~     sclerosis (RRMS). A secondary objective is to evaluate the pharmacodynamic effect on absolute~     lymphocyte counts (ALCs) and immunoglobulins (Igs) during the first year of treatment.~   "
79538|NCT02525861|"~     The purpose of the study is 2-fold: (1) to further evaluate the safety and potential~     immunogenicity of GLASSIA following IV administration via in-line filtration; and, (2) to~     assess the effects of GLASSIA augmentation therapy on the levels of A1PI and various~     biomarkers in the epithelial lining fluid (ELF) following intravenous (IV) administration at~     a dosage of 60 mg/kg Body weight (BW)/week active A1PI protein for 25 weeks in subjects with~     emphysema due to congenital A1PI deficiency.~   "
79539|NCT02525848|"~     To evaluate the efficacy of pre-empetive administration of Aprepitant, Versus Gabapentin~     prophylaxis for reducing the incidence of postoperative nausea and vomiting in Laproscopic~     gynacological surgeries.~   "
79540|NCT02525835|"~     This pilot study will test the hypothesis that a low sodium diet will decrease sodium (23Na)~     magnetic resonance imaging-determined skin sodium concentrations in patients with systemic~     lupus erythematosus (SLE) and improve blood pressure and inflammation~   "
79541|NCT02525822|"~     The primary objective of this study is to compare the safety and efficacy of once daily~     application of IDP-123 Lotion to Tazorac Cream, 0.1%, Vehicle Lotion, and Vehicle Cream in~     subjects with moderate to severe acne vulgaris.~   "
79542|NCT02525809|"~     The total hip replacement, with over 120,000 cases per year in France, provides short term,~     excellent functional results and a significant improvement in quality of life, in almost all~     cases. However, observation showed that the dislocation is not a rare complication (2-4%) and~     the lifetime of the implants is limited due to aseptic loosening.~      The evaluation process used in this study will be the extent of penetration of the metal~     femoral head in the cup and micro mobility metal back by radiostereometric analysis (RSA)~     whose precision provides early results (2 3 years), long before wear and migration are~     measurable by conventional radiological means. The main objective will be to compare, 2 years~     after the intervention, the penetration of the metal femoral head in 3 types of inserts: two~     dual mobility inserts, one at tripod attachment (Novae E®), the other press fit pure~     (Sunfit®), and a fixed insert (Quartz®).~      This is a randomized controlled trial. 105 patients will be enrolled (35 in each group).~     Patients will be included in each of the two participating centers (Amiens, Caen). The~     analysis will be made in RSA D7 + 2, 6 months 1, 12 months 1 24 months 1. An assessment will~     be made to 3 years if the analysis requires it to 2 years.~      Analysis of pictures will be centralized in Caen and performed with specific software after~     transferring images via a secure network.~   "
79543|NCT02525796|"~     This study will evaluate whether blocking the mineralocorticoid receptor, alone, or in~     combination with the calcimimetic cinacalcet, can lower parathyroid hormone and calcium~     levels in primary hyperparathyroidism.~   "
79544|NCT02525770|"~     Total hip arthroplasty (THA) is one of the most effective medical procedures. Except for the~     few early complications (acute infections and dislocations), the patient made a PTH can be~     assured of a significant improvement in its function and its short-term quality of life.~     However, clinical studies and records have shown that the lifetime of these implants was~     limited. The main cause of failure is the aseptic loosening influenced by many factors,~     foremost of which is due to periprosthetic osteolysis debris. This is a major concern for~     orthopedic surgeons loosening leads, in most cases, the recovery, the importance of~     osteolysis is a major cause of difficulties and poorer results.~      The main objective of the study is to compare, 2 years after the intervention, the~     penetration of the femoral head in the polyethylene and X3 in the acetabulum in N2VAC®~     conventional polyethylene.~   "
79545|NCT02525757|"~     The goal of this clinical research study is to learn about the safety of adding MDPL3280A to~     standard chemotherapy (a combination of carboplatin and paclitaxel) and radiation in patients~     with lung cancer.~      You are being asked to take part in this study because you have non-small cell lung cancer~     (NSCLC) that is unresectable (cannot be removed by surgery) and has not spread.~      This is an investigational study. MPDL3280A is not FDA approved or commercially available. It~     is currently being used for research purposes only. Paclitaxel, carboplatin, and the~     radiation therapy are all FDA approved for the treatment of lung cancer. The use of these~     drugs in combination is considered investigational.~      Up to 40 participants will be enrolled in this study. All will take part at MD Anderson.~   "
79546|NCT02525744|"~     This study evaluates a new formulation of LY900014, a drug that lowers blood sugar. It is~     administered by injection under the skin of the abdomen. The study will be conducted in~     healthy people to investigate how quickly and how much LY900014 is absorbed and the effect of~     different doses of LY900014 on blood sugar levels. Side effects and tolerability will be~     documented. The study will last for about 8 to 9 weeks for each participant, including~     screening and follow up. Screening is required within 28 days prior to entering the study.~   "
79547|NCT02525731|"~     The TEACH patient cohort will characterize a clinic sample of HIV-infected patients on~     chronic opioid therapy (COT) by describing basic demographics and health status, including~     characteristics of pain (severity and interference), aberrant behaviors/misuse of COT,~     substance use and trust/satisfaction with providers. In addition, data on a subset of~     participants will be used to supplement analysis of secondary outcomes for the TEACH~     randomized controlled trial (RCT), an intervention study directed at COT providers (outlined~     in a separate Clinical Trials Protocol Registration and Results (PRS) summary).~   "
79548|NCT02525718|"~     Subjects are being asked to participate in this study because they will be undergoing~     unilateral (one) or bilateral (two) mastectomy surgery with immediate reconstruction~     involving insertion of a tissue expander.~   "
79549|NCT02525705|"~     The purpose of this study is to evaluate the prevalence at 3.5 months of age of dumping~     syndrome in children operated at birth for oesophageal atresia type III et IV.~   "
79550|NCT02525692|"~     ONC201 is a new drug candidate that kills cancer cells but not normal cells in laboratory~     studies and has been previously evaluated in a phase I clinical trial in advanced cancer~     patients. This clinical trial will enroll patients with recurrent glioblastoma or recurrent~     WHO Grade IV gliomas with the H3 K27M mutation.~   "
79551|NCT02525679|"~     The aim of this study is to investigate the safety and tolerability of BI 655130 in healthy~     male subjects following single rising low, medium and high doses.~   "
79552|NCT02525666|"~     Investigation of a bilateral inguinal hernia repair using one large self-fixating mesh~     covering both groins. Health outcomes are assessed using different questionaires with focus~     on urinary symptoms (with ICIQ-MLUTS score), the recurrence rate, postoperative pain~     measurement, and Quality of Life assessment with EuraHS-QoL and chronic pain monitoring for~     12 months.~   "
79553|NCT02525653|"~     The purpose of this study is to test the safety and effectiveness of albumin-bound paclitaxel~     plus gemcitabine in patients with advanced squamous cell lung cancers. The investigators~     would like to determine the percentage of patients with squamous cell lung cancers who~     experience shrinkage of their tumors following treatment with this regimen. This combination~     of drugs is not a standard therapy for patients with squamous cell lung cancers. However,~     each of these drugs, when given alone or with other chemotherapies, is FDA-approved for the~     treatment of this disease.~   "
79554|NCT02525640|"~     Single sided deafness (SSD) refers to asymmetrical hearing loss, where there is a significant~     worsening of hearing in one ear compared to the other.~      In Cambridge, the investigators see large numbers of patients with SSD caused by vestibular~     schwannomas, due to their affiliation with the Neuro-Otology Department, with over 100 new~     SSD patients being referred every year.~      Only a small number of studies have explored hearing handicap for those with SSD, and music~     appreciation has not been investigated, to the best of the investigators knowledge, in this~     patient group.~      In the limited number of studies conducted on those with single sided deafness, often only~     one or two outcome measures have been used, or the patient group has been small. The~     investigators have a large group of patients with a wide range of aetiologies who have~     completed several questionnaires as part of their treatment in the single sided deafness~     clinic and the investigators would like to analyse these data.~      At present there are different devices available on the NHS for the management of SSD and~     many studies have explored benefits of Bone Anchored Hearing Aids (BAHA). There is an~     under-representation of studies looking specifically at CROS aid devices which is relevant~     given the cost differences involved between devices.~      Study goals and objectives~        -  To find out what factors drive hearing handicap in SSD patients by analysing the results~          of several different well validated hearing handicap questionnaires~        -  To find out whether or not it is possible to change hearing handicap in this patient~          group by looking to see if there is an improvement in questionnaire scores post~          treatment.~        -  The investigators will also look at a sub-group who will be fitted with both traditional~          wired CROS aids and more up-to-date wireless aids which have been funded through a~          research grant, in order to assess whether these are more beneficial.~        -  The investigators will use a new questionnaire developed in-house to further explore the~          impact of single sided deafness on music appreciation.~   "
79555|NCT02525627|"~     Prospective, singlecentre, randomized clinical study; series of patients with a 5-years~     patient evaluation period.~   "
79556|NCT02525614|"~     The objective is to investigate the Clinical, Radiographic, Roentgen Stereophotogrammetric~     behaviour and patient outcome when using the Triathlon total knee prosthesis in a prospective~     randomized clinical trial.~   "
79557|NCT02525601|"~     The objective is to investigate the Clinical, Radiographic, Roentgen Stereophotogrammetric~     behaviour and patient outcome when using the Triathlon total knee prosthesis in a prospective~     randomized clinical trial.~   "
79558|NCT02525588|"~     Comparison of conventional UHMWPE (ultra-high-molecular-weight polyethylene) with X3 highly~     cross-linked polyethylene in a CS (condylar stabilizing) fixed bearing total knee prosthesis~     by means of RSA and clinical evaluation.~   "
79559|NCT02525575|"~     For suicidal individuals, minimizing future risk and fostering recovery are critical public~     health concerns, especially among Veterans, as very few effective interventions exist. This~     proposal tests a novel group psychotherapy treatment that combines emotion regulation skill~     based, and psychoeducational approaches, with suicide safety planning development and~     implementation.~      Project Life Force (PLF), a novel suicide safety planning group intervention has been~     designed to fill this critical gap and provide a mechanism to develop and enhance suicide~     safety planning over time. PLF, a 12-session, group psychotherapy intervention, combines~     Dialectical Behavioral Therapy (DBT) skill based and psychoeducational approaches, to enhance~     suicide safety planning development and implementation. Veterans revise their plans over~     several weeks while learning distress tolerance, emotion regulation, and friendship~     building/interpersonal skills to incorporate into their safety plans and also receive lessons~     on gun safety and minimizing access to lethal means. Sessions are augmented with 1) training~     in the use of a suicide safety planning mobile App to promote accessibility and maximize~     implementation, and 2) didactic information to bolster recovery, including fostering improved~     connection with the treatment team, and Veteran's family.~   "
79560|NCT02525562|"~     Provide outcomes information with regard to surgical and implant performance and patient~     clinical outcomes of the patients who are eligible for either a Total Knee Arthroplasty (TKA)~     replacement surgery or Partial Knee Resurfacing (unicompartmental knee arthroplasty, UKA)~   "
79561|NCT02525549|"~     The purpose of this study is to compare the safety and bioequivalence of Perrigo's product to~     an FDA approved product for the treatment acne vulgaris.~   "
79562|NCT02525536|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic (PK)~     profile of trebananib (AMG 386) after intravenous administration in adult Japanese~     participants with advanced solid tumors.~   "
79563|NCT02525523|"~     A Phase III, multi-centre, double-blind randomised controlled trial in subjects with chronic~     antibiotic refractory pouchitis.~      Subjects will undertake a <2 week screening period to provide baseline data and be assessed~     for eligibility. At the Baseline visit (Day 1) eligible subjects will be randomised on a 1:1~     basis to either a) 240 mg alicaforsen enema or b) matching placebo.~      Study drug will be administered once nightly (on going to bed) up to and including week 6.~     Following the Day 1 Visit, subjects will return to the clinic for safety and efficacy~     assessments at Week 3, 6, 10, 18 and 26.~      Subjects may receive certain permitted medications as per Entry Criteria, which must remain~     at stable doses throughout the trial. Introduction of any new medication for pouchitis, or a~     dose change to an existing concomitant medication for pouchitis, other than those detailed in~     the protocol, will not be permitted.~      Clinical symptoms associated with pouchitis will be recorded daily by the patient in a diary~     card.~      Subjects will undergo endoscopic examination of their pouch (during Screening, and at Weeks 6~     and 10). Where technically feasible, each endoscopy will provide at least one biopsy sample~     for histopathology.~      In addition to endoscopic, histopathologic and symptomatic assessments, Quality of Life will~     be assessed.~      Bloods for routine assessment, including haematology and biochemistry will be taken. Bloods~     and stool samples will be collected to evaluate relevant biomarkers.~   "
79564|NCT02525510|"~     To protect kidney function during the transplantation process by comparing mild hypothermia~     in the deceased organ donor before organs are recovered and pulsatile perfusion of the kidney~     after recovery and prior to transplantation.~   "
79565|NCT02525497|"~     This study is a randomized, multi-center，crossover study of a domestic FM peritoneal dialysis~     machine and Baxter HOMECHOICE.It aims to verify safety, effectiveness and manipulability of a~     domestic peritoneal dialysis machine.~   "
79566|NCT02525484|"~     This is a Phase I, open-label, randomized, four-treatment period, four-sequence, single-dose,~     crossover pharmacokinetic study to determine the bioequivalence of pirfenidone after~     administration of tablet and capsule dosage forms under both fed and fasted conditions.~   "
79567|NCT02525471|"~     The purpose of this study is to determine the safety and tolerability of RNS60 in patients~     with Amyotrophic lateral sclerosis (ALS). Investigators will also measure the impact of RNS60~     on several markers of neuro-inflammation, measured by blood biomarkers and positron emission~     tomography (PET) imaging.~   "
79568|NCT02525458|"~     One of the major challenges in orthodontic treatment is long-term stability. Because~     removable retainers are worn for at least one year, bacteria and fungi may accumulate on the~     retainers in the form of multi-species plaque biofilms. This may result in increased~     incidence of proximal dental caries or oral candida infection. Thus, incorporation of~     antimicrobial activity in orthodontic acrylic resin to achieve plaque biofilm reduction is~     highly desirable. An antimicrobial and antifungal quaternary ammonium methacryloxy silicate~     molecule (QAMS) has been synthesized by sol-gel reaction and incorporated into orthodontic~     acrylic resin. The QAMS-copolymerized acrylic resin demonstrated contact-killing properties~     against single-species biofilms in previous in vitro studies and has received US FDA 510(K)~     clearance for marketing. The objective of the present randomized clinical trial is to~     determine the in vivo antimicrobial efficacy of the QAMS-containing orthodontic acrylic by~     using removable retainers that are worn by recruited subjects to create 48-hour multi-species~     plaque biofilms. The null hypothesis tested is that there is no difference in the~     antimicrobial activities between QAMS-free and QAMS-containing orthodontic acrylic resin on~     oral biofilms grown in vivo in human subjects.~   "
79569|NCT02525445|"~     The purpose of this study is to investigate if it is possible to influence the participants'~     expectations to improve outcome, in this particular setting the relaxing effects of one~     single acupuncture treatment with genuine or sham needles combined with positive or neutral~     communication regarding expected relaxing effects.~   "
79600|NCT02525042|"~     The main objective is to identify in the candidate regions of differentially expressed genes~     by comparing the transcriptome of dendritic cells derived from circulating monocytes between~     cases and controls. Cases and family controls will be matched on the presence of HLA-B27 and~     depending on haplotype association studies to correlate the differences of gene expression~     and genetic variations with susceptibility to AS.~   "
79601|NCT02525029|"~     The purpose of this study is to determine the maximum tolerated dose (MTD) of Pregnyl® when~     given in combination with standard immunosuppressive therapy in pediatric and adult patients~     with high-risk (Arm 1) or refractory/dependent (Arm 2) aGVHD.~   "
79570|NCT02525432|"~     The purpose of this study is to determine the effect of intravenous infusion of autologous~     bone marrow mononuclear cells (BMMNC) on brain structure and neurocognitive/functional~     outcomes after severe traumatic brain (TBI) injury in adults. The primary objective is to~     determine if the intravenous infusion of autologous BMMNC after severe TBI results in~     structural preservation of global gray matter (GM) volume and white matter (WM) volume and~     integrity; as well as select regions of interest in the corpus callosum. THe secondary~     objectives are to determine if autologous BMMNC infusion improves functional and~     neurocognitive deficits in adults after TBI; reduces the neuroinflammatory response to TBI;~     evaluate spleen size and splenic blood flow over time using ultrasound and corresponding~     changes in inflammatory cytokines; and infusion related toxicity and long-term follow-up~     safety evaluations.~   "
79571|NCT02525419|"~     This study systematically quantified the effects of intermittent fasting and caloric~     restriction (IFCR) on total and regional (abdominal) body composition (lean mass and fat~     mass), blood lipids, toxins, oxidative stress biomarkers, energy expenditure, and substrate~     utilization in 43 overweight/obese middle-aged men (n=22) and women (n=21). Participants were~     enrolled in the study as a single cohort and participated in an 12-week trial consisting of~     two consecutive phases: 1) 1-week baseline, weight maintenance control phase (C), and 2)~     11-week weight loss IFCR phase. During the 1 week C phase, volunteers were required to~     maintain their body weight by consuming their normal food intake; however, during the 11 week~     IFCR, subjects were instructed to consume 75% of their normal intake to result in a 1-2 lb of~     body weight loss per week. At the conclusion of the 12 week weight loss study, all 40~     participants (3 drop-outs) were invited to enroll in a 12 month follow up study. If they~     agreed to participate, groups were balanced so there were similar numbers of men and women~     and were weight-matched. The two groups (n=37, 3 dropped prior to allocation) included: 1) a~     modified version of the 12 week weight loss intervention that consumes whole foods along with~     2 meal replacements (rather than 3) (MR; n=19) or 2) a whole foods diet similar to the~     Therapeutic Lifestyle Changes diet recommended by the National Institute of Health (TLC, n=~     18) and asked to follow these nutritional guidelines ad libitum for the duration of 12~     months.~   "
79572|NCT02525406|"~     The goal of the study is to identify factors that enhance productivity and increase value~     delivered by hospitals drawing on concepts used in industry for quality and productivity in~     production and operations management literature. The investigators intend to look at surgeon~     experience, patient characteristics and pre-admission testing on operating room productivity.~   "
79573|NCT02525393|"~     Patients were randomized in 3 groups: two intervent groups and a control group. The first~     group received two weeks of daily session of repetitive Transcranial Magnetic Stimulation~     (rTMS, 10 sessions) and, at least 6 months after, two weeks of daily transcranial Direct~     Current Stimulation (tDCS, 10 sessions); the second group received 10 daily session of tDCS~     and, after at least 6 months, 10 sessions of rTMS; the control group received 10 daily~     session of sham tDCS.~      Physiatric evaluations (ARAT scale), neuropsychological assessment and ERP (P300) were~     performed before (1 week) and after (1 week) the end of each treatment. Furthermore, all~     patients underwent follow-up neuropsychological assessment 6 months after the end of each~     stimulation period and follow-up physiatric evaluation at 3 and 6 months after the end of~     each stimulation period.~   "
79574|NCT02525380|"~     Safety and efficacy of doxorubicin-eluting-bead embolization in patients with advanced~     hepatocellular carcinoma.~   "
79575|NCT02525367|"~     In Parkinson's disease, Multiple Sclerosis and depressed patients treated with~     electroconvulsive therapy, cognitive dysfunction is prevalent. However, treatment of these~     dysfunctions is in its infancy.~      The purpose of this study is 1) to assess the feasibility of a randomized controlled trial~     using an online computerized intervention for training cognitive abilities in the three~     patient groups and 2) to estimate the effect of the online training on objectively and~     subjectively measured cognitive functions.~      The investigators hypothesize that patients using online cognitive training will improve more~     on cognitive functions, as compared to patients using an active control condition.~   "
79576|NCT02525354|"~     Epidemiological studies have shown obesity to be a risk factor of asthma. Research evidence~     of obesity and atopic(ie. allergic)-related respiratory diseases, has been less clear. The~     purpose of the present study was to test the hypothesis that the relationship between obesity~     and atopic-related respiratory disease in premenopausal women is mediated by a dietary~     imbalance of omega 6 and 3 polyunsaturated fatty acids.~   "
79577|NCT02525341|"~     The purpose of the study is to examine the short and long term effects of Hatha yoga compared~     to the current recommended exercise program in promoting physical function, alleviating~     osteoarthritis (OA)-related symptoms, fear of falling, and improving mood, spiritual health,~     physical activity level, and quality of life in older adults with knee OA, and to determine~     the effect sizes for use in power calculations to design a larger efficacy clinical trial.~   "
79578|NCT02525328|"~     Constitutional thinness (CT) is a recently defined entity as a differential diagnosis of~     anorexia nervosa (AN), considered to be the most frequent cause of low body mass index (BMI)~     in young women. CT subjects present no AN psychiatric traits, preserved menses, no biological~     signs of undernutrition and balanced energy metabolism despite a Body Mass Index (BMI) <17 kg~     / m².~      CT familial aggregation, low body mass without a hormonal explanation, and specific appetite~     regulation profile suggest a specific genetic profile in these subjects.~      Objective: A family linkage study in order to identify genes involved in the constitutional~     thinness phenotype by using genome wide scan (GWAS) techniques Studied population: Fifty~     families including at least one well phenotyped CT index case (grade 2 or 3 of thinness~     according WHO classification). Blood or saliva is sampled for DNA extraction.~      Perspectives: Revealing eventual abnormalities could lead to a more precise diagnosis of~     constitutional thinness and new hypothesis in understanding extreme bodyweight mechanisms.~   "
79602|NCT02525016|"~     Intravenous lidocaine is efficient for management of post operative pain in abdominal~     surgery. As previously published in literature the investigators use it during bariatric~     surgery.~      Nevertheless plasmatic concentration of lidocaine is unknown in this population, despite a~     widespread use.~      Investigators propose in this work to bring an objective proof that administration of~     lidocaine based on a modified body weight is safe.~      Intravenous administration concerned the peri operative period. A total of six samples are~     taken for each patient.~      Investigators get approbation of local ethic committee for this work.~   "
79579|NCT02525315|"~     Auditory hallucinations are common (present in 60-70% of cases) and extremely debilitating.~     Behavioral disorders associated with them can have serious social repercussions. However, in~     25% of cases the usual antipsychotic drug treatments are incompletely or totally ineffective.~      Fifteen subjects will be included after collection and signed their informed consent.~      The rTMS treatment is made of 4 sessions of 13 minutes spread over two days, at a frequency~     of 20 Hz and an intensity of 80% of motor threshold at rest. These constants are used to stay~     below the risk of occurrence of seizures, the only serious side effects identified.~     Furthermore the rTMS treatment is almost painless: tension headaches are the main side~     effects and make amends with simple analgesics. rTMS is devoid of neurocognitive effects. The~     LEFT stimulation site will be established through a anatomofunctional imaging before~     treatment (between D-7 and D0).~      Treatment efficacy will be evaluated daily during treatment (days 1 and 2) and during the~     first 2 weeks of starting treatment.~   "
79580|NCT02525302|"~     This study, HALO-DMD-03, is a follow-on study to HALO-DMD-01 and HALO-DMD-02, and allows~     continued open-label access to HT-100 for subjects who have completed these studies.~     HALO-DMD-03 will provide safety and strength and function data on continuous long-term~     dosing. Data from this study will be used to inform the safety, tolerability, and dose~     selection for a future trial of HT-100 in boys with Duchenne Muscular Dystrophy (DMD).~   "
79581|NCT02525289|"~     To investigate different strategies of body positioning associated to early corporal~     mobilization and verify the impact int the time and quantification of thoracic and~     mediastinal drainage, pulmonary complications and time of intensive care units in hospitals~     stay. After first six hours post extubation in the first postoperative day and after~     evaluation and inclusion in the study, patients were randomized in three groups for receiving~     different strategies of body positioning associated to early mobilization with help of bed~     Hill Rom (Hill Rom Batesville@): Group 1: Control (GC n=33); Group 2: Continuous Lateral~     Rotation Group (TRCL n=34); Group 3:Positioning in sitting and Orthostatic (ORT n=34).~   "
79582|NCT02525276|"~     The main objective of this study is to investigate the role of female sex hormones in~     relation to insulin resistance in a controlled human experimental model of menopause and to~     explore whether exercise and/or hormone treatment (HT) can compensate for loss of endogenous~     sex hormone production by maintaining insulin sensitivity and metabolic activity at a level~     equivalent to what is seen in premenopausal women.~      Loss of ovarian function is associated with an increased incidence of metabolic disease~     including metabolic syndrome, type 2 diabetes and cardiovascular disease. This increased~     disease incidence seems to be related to changes in body composition including decreased~     skeletal muscle mass and increased visceral fat mass as well as decreased whole body fat~     oxidation and energy expenditure. Regular physical activity decreases general mortality among~     other things by increasing fat free mass and insulin sensitivity and hereby prevents~     metabolic syndrome and cardiovascular disease - conditions seen with an increased incidence~     after menopause and could therefore be a possible treatment.~      In the present study the Investigators will assess the role of sex hormones in a model of~     menopause where healthy women are undergoing planned bilateral oophorectomy due to risk of~     hereditary ovary cancer. The use of this model makes it possible to control the time point~     for loss of ovarian function and hereby investigate the timeframe and possible contributing~     factors in a strictly controlled model. 48 premenopausal women will be included in the study.~     The study is conducted in women who have already been offered surgical oophorectomy. The~     first 2 months the study will be an observational cohort study. Hereafter the patients will~     be allocated to one of four groups (n=12) in a randomized controlled trial, addressing the~     effects of 6 months of exercise with or without HT. Type of surgery has been decided before~     inclusion based on medical indications. The women will be offered HT according to national~     guidelines, but the choice is up to them. Randomization applies only to the training~     intervention.~      Firstly the Investigators aim at investigating the role of endogenous female sex hormones and~     HT in relation to insulin resistance, whole body fat oxidation and -energy expenditure,~     changes in visceral fat mass and fat free mass after oophorectomy. Secondly, the~     Investigators wish to study the molecular mechanisms behind the oophorectomy-induced insulin~     resistance with a focus on insulin signaling in skeletal muscle and fat tissue. Lastly, the~     investigators aim to explore whether exercise and/or HT can compensate for loss of endogenous~     female sex hormone production by maintaining IS and metabolic activity, hereby preventing~     future incidents of metabolic disease in relation to menopause.~      All in all, this project will contribute with new knowledge concerning the question of how~     endogenous female sex hormones affect insulin sensitivity and metabolic functioning and how~     exercise may be used as a disease preventive modality for middle-aged women.~   "
79583|NCT02525263|"~     A Phase II, Open-Label Safety and Efficacy Study of an Autologous Neo-Kidney Augment (NKA) in~     Patients With Type 2 Diabetes and Chronic Kidney Disease (RMTX-CL001). NKA is made from~     expanded autologous selected renal cells (SRC) obtained from the patient's kidney biopsy. All~     enrolled subjects will be treated with up to two injections of NKA at least 6 months apart.~   "
79584|NCT02525250|"~     This project is a framework for developing new therapeutic strategies for acute myeloid~     leukemia(AML)based immunotherapy.~      the role of NK cells was demonstrated in AML and especially GVL effect (graft versus~     leukemia) during allogeneic transplantation in these patients. However, it has been shown~     that the phenotype of NK cells and their cytotoxic functions were altered during this~     malignancy. In addition, in these patients, impaired NK function is associated with relapse.~      lenalidomide it would have a beneficial effect on NK cells of AML patients? Does it have a~     role in leukemic cells in this malignancy? what is its effect on the production of~     pro-inflammatory cytokines? In vitro data show an effect of lenalidomide on the phenotype of~     NK cells from healthy donors and patients with LAM, and despite these phenotypic changes, the~     cytotoxic capacity of NK is not altered.Lenalidomide also induces a significant increase in~     the production of TNF-alpha (tumor necrosis factor) by NK.~      It also seems to have an effect on leukemic blasts of AML. So, the investigators hope this~     study confirm these results in vivo in peripheral blood cells in patients treated with~     lenalidomide.~   "
79585|NCT02525237|"~     The purpose of this study is to evaluate the efficacy and safety of Apatinib combined with~     S-1 as first-line therapy for patients with advanced gastric or gastroesophageal junction~     adenocarcinoma.~   "
79586|NCT02525224|"~     Healthy skin has been equated with a healthy diet leading to the inside out approach to~     skin health. Since the skin is the barrier to the external world, healthy skin should lead to~     overall better health. Conversely, the skin derives its nutrition from the internal body~     requiring the consumption of nutritional supplements for optimal health. This research~     attempts to examine skin attributes and improved appearance achieved after consumption of a~     state-of-the-art dietary supplement.~   "
79611|NCT02524899|"~     This is a study to assess the efficacy augmenting cognitive remediation therapy (CRT) with a~     pharmacological agent for individuals with schizotypal personality disorder (SPD). Impaired~     cognition, along with functional and social skill deficits, is a core feature of~     schizophrenia and schizophrenia spectrum disorders. A better understanding of the cognitive~     and functional impairments in schizophrenia-related conditions, as well as the identification~     of interventions that can reduce these impairments, are vital to improving outcomes for~     individual with these disorders.~   "
79717|NCT02523508|"~     Previous studies have shown that peripheral muscles weakness or inhibition is related to~     spinal disorders. Passive mobilization and manipulation are likely to reverse such muscle~     weakness. The purpose of the study was to assess the effect of spinal mobilization on the~     maximal muscle strength of the hip flexors and motor function.~   "
79587|NCT02525211|"~     The acute pain care, in particular after breast cancer surgery must be early and quickly~     effective, because a severe postoperative pain increases the risk of chronic pain and exposes~     to a risk of important embarrassment for the realization of simple daily movements.~      Associated to conventional analgesics administered by systemic way, a local anesthesic~     (ropivacaine) can be continuously infused (Continues Cicatricial Perfusion CCP) in the~     operating wound by a multi-drilled catheter by means of a elastomeric diffuser set up in the~     surgical unit by the surgeon at the end the surgical procedure.~      Besides the control of the postoperative acute pain, the local anesthesic could intervene in~     the prevention of the chronic pain, the early recovery, the reduction of the neuropathic~     pains and the decrease of needs in morphine after mastectomy.~      The duration of hospitalization being lower than 48 hours for this type of surgery, the~     investigators envisage an immediate follow-up in the Units of Care then at home, what will~     require a training of the hospital actors and at home (patient, family, visiting nurse,~     general practitioner).~      Although proposed for several years, the CCP after breast surgery is still a little spread~     technique and few works had evaluated the pain at rest and at mobilization after mastectomy,~     the early rehabilitation, and to spread its use towards home, that is why we propose a~     randomized double-blind study ropivacaine / placebo in patients after mastectomy.~   "
79588|NCT02525198|"~     There is a dearth of research which takes a multi-compound approach to dietary interventions,~     in humans, aimed at improving outcome measures of cognition. Animal research in particular~     points towards fatty acids and flavonoids having a potentiating effect on each other, and~     possibly even being synergistic. Thus, study products will be administered in the present~     trial comprising both of these compounds, with a view to investigating their potential~     effects on cognition in older adults with mild cognitive impairment (MCI) or subjective~     memory impairment (SMI).~   "
79589|NCT02525185|"~     Cardiac resynchronisation therapy (CRT) has been documented to be a powerful treatment in~     patients with severe congestive heart failure. However, 30-40% of patients receiving a CRT~     are non-responders. In this study the investigators will use a previously validated method to~     estimate myocardial segment work non-invasively by speckle-tracking echocardiography and~     blood pressure. Since segments which shorten in systole perform positive work, whereas~     segments which lengthen do negative work, the investigators will calculate wasted work as~     negative work in percentage of positive work. The main purpose of the study is to determine~     if wasted work can predict response to CRT.~   "
79590|NCT02525172|"~     The purpose of this study is to assess anti-recombinant human acid α-glucosidase (anti-rhGAA)~     antibody titers after treatment with immune modulation therapy in patients of Pompe disease.~   "
79591|NCT02525159|"~     Breast cancer is a public health problem in Mexico and its incidence rises when the woman is~     still premenopausal. Estrogen metabolism has been linked to breast cancer. Several studies~     reported that high concentrations of 2 hydroxyestrone (2OHE1) in urine have a protective~     effect for this neoplasia, whereas high concentrations of 16 alpha-hydroxyestrone (16αOHE1)~     in urine have the opposite effect, further has been reported that women with a ratio of~     estrogen metabolites 2OHE1:16αOHE1 in urine (REMU) less than 0.9, have ten times the risk of~     developing Breast Cancer than those women with an RMEU equal or more than 0.9. Other studies~     have showed that the active compounds of cruciferous vegetables, indole-3-carbinol (I3C) and~     its dimer, 3'3'diindolylmethane (DIM) induce benign pathway of metabolism of estrogens~     producing 2OHE1. Several studies, evaluate the pharmacokinetics and effect of I3C~     supplementation, finding that 300 to 600 mg of this compound are well tolerated and able to~     promote formation of 2OHE1 in women when supplemented for one month. In the case of DIM, only~     a pilot study has explored its effect in postmenopausal women with personal history of breast~     cancer in early stages, reporting an increase in the concentrations of 2OHE1. The purpose of~     this study was to evaluate the effectiveness of supplementation with DIM to increase urinary~     RMEU in premenopausal women at risk of Breast Cancer (RMEU less than 0.9). A clinical,~     randomized, double-blind study was performed with women attending on the urogynecology~     service of Institute National of Perinatology. Subjects were premenopausal women over 34~     years who were healthy. The inclusion criteria's was had a RMEU less than 0.9 and were~     excluded for any medical condition, medication, or dietary or lifestyle habit that might~     interfere with estrogen metabolism. Patients were randomly assigned to one of two groups: one~     received orally at a daily dose of 75 mg of DIM for a period of 30 days and other group~     received orally at a daily placebo for a period of 30 days. All urine samples were collected~     from the women before DIM or placebo ingestion, after 30 days of DIM or placebo ingestion and~     finally after another 30 days once suspended supplementation. Analysis of the 2OHE1 and~     16αOHE1 were determined using a commercially kit ESTRAMET™. The change in metabolites median~     concentrations and RMEU was assessed through the Wilcoxon test and these differences between~     groups through U Mann-Whitney test.~   "
79592|NCT02525146|"~     The purpose of this study is to determine whether a modified form of the ARTAS~     (Antiretroviral Treatment and Access to Services) intervention, adapted for HIV patients who~     have fallen out of care, can be successful in re-engaging patients in care and reducing HIV-1~     viral load.~   "
79593|NCT02525133|"~     This is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled~     efficacy and safety study of postoperative pain in adults who are scheduled for unilateral~     inguinal hernioplasty via open laparotomy (tension-free technique).~      Patients will assess their postoperative pain intensity (PI) using an 11-point numerical~     rating scale (NRS) from 0 hour through 72 hours postoperatively.~      The expected maximum study duration for each patient will be up to 60 days, including a~     maximum 30-day screening period, the day of surgery and implantation, and a 30-day post~     implantation period including treatment and follow-up.~   "
79594|NCT02525120|"~     The primary objective of this study is to compare the early clinical outcomes following~     non-surgical treatment with Triojection® to surgical discectomy. Early is defined as less~     than or equal to 6 months.~   "
79595|NCT02525107|"~     140 SCD patients [70 on Hydroxyurea] will receive Omega-3 capsules whereas another 140 SCD~     patients [70 on Hydroxyurea] will receive placebo and will be recruited from the Sultan~     Qaboos University Hospital [SQUH] haematology specialty clinics. Patients will be randomized~     in a 1:1 ratio to receive placebo or Omega-3 for 52 weeks. The aim is to investigate the~     therapeutic potential of omega-3 fatty acids in the prevention of vaso-occlusive crisis in~     Omani patients with sickle cell disease[SCD].~   "
79596|NCT02525094|"~     To assess the efficacy and safety of MEDI9929 in adult subjects with Atopic Dermatitis~   "
79597|NCT02525081|"~     The aim of this study is to explore effects of long term treatment with ACE-inhibitor on the~     small vessel function assessed by coronary flow reserve (CFR) by transthoracic~     echocardiography and flow mediated dilation in normotensive patients with small vessel~     disease (CFR<2.2) and Angina Pectoris but no obstructive coronary artery disease.~   "
79598|NCT02525068|"~     A multicentre prospective, randomised, phase II interventional study in mCRPC patients~     previously treated with 1‐2 lines of chemotherapy and at least 12 weeks of abiraterone with a~     safety run‐in and single stage phase II expansion cohort.~   "
79603|NCT02525003|"~     Vitamin D3 is synthesized in skin exposed to ultraviolet-B-irradiation of sunlight. However,~     in Northern Europe, including Finland, exposure to sunlight is limited or non-existent in~     winter. Between November and March, dietary or supplementary vitamin D intake is essential to~     maintain adequate serum 25-hydroxyvitamin D (S-25(OH)D) concentrations. There are only a few~     natural dietary sources of vitamin D. Fish and egg yolks contain significant amounts of~     vitamin D3 (cholecalciferol), and some wild mushrooms are a source of vitamin D2~     (ergocalciferol). Thus, vitamin D fortification of certain foods has been accepted as one~     strategy to improve vitamin D status of these populations. Vitamin D3 is currently mostly~     used in fortified products in Europe, although the production of plant-derived vitamin D2~     would be more cost-effective. Data on the impact of food-derived vitamin D2 on S-25(OH)D3 are~     limited. An important consideration is whether food-based sources of vitamin D2 are effective~     in raising S-25(OH)D or whether they have a negative impact on S-25(OH)D3. The investigators~     investigated the bioavailability of vitamin D2 from UVB-radiated baking yeast in bread in~     terms of efficacy of raising total S-25(OH)D) as well its possible effects on S-25(OH)D2,~     S-25(OH)D3, serum parathyroid hormone (S-PTH) and serum calcium concentrations compared with~     D2 and D3 supplementation in a randomized placebo-controlled trial in young healthy females~     during winter in Finland.~   "
79604|NCT02524990|"~     The purpose of this operations research study is to evaluate women's interest in and~     compliance with using a semiquantitative multi-level dipstick pregnancy test at home for~     medical abortion follow-up.~   "
79605|NCT02524977|"~     Study objective was to improve decision-making and thromboprophylaxis for patients with~     Atrial Fibrillation (AF) by developing and implementing a computerized decision support tool~     for individual patient-level decision-making about oral anticoagulant therapy. To accomplish~     these goals, the investigators studied the incremental impact of adding a quality-improvement~     (QI) intervention to an educational package (for practice staff and clinicians) using a~     computerized aid, the Atrial Fibrillation Decision Support Tool (AFDST) for individual~     patient-level decision-making about oral anticoagulant therapy in patients with non-valvular~     AF. The decision support tool incorporates individual patients' risk factor profiles for~     ischemic stroke and bleeding and provides a recommendation for treatment based upon the~     projected quality-adjusted life expectancy gained or lost with the addition of either oral~     anticoagulant therapy or aspirin compared with no thromboprophylaxis.~   "
79606|NCT02524964|"~     Approximately 60 patients with ST-segment elevation myocardial infarction successfully~     treated with primary percutaneous coronary intervention will be enrolled and randomized to~     receive the sodium tanshinone IIA sulfonate in addition to standard therapy or the same~     volume/day of normal saline.~      The primary endpoint is the variation in LV end-diastolic volume index (LVEDVi) assessed with~     cardiac magnetic resonance imaging (MRI) at baseline and 6 months.~   "
79607|NCT02524951|"~     This is a Phase I, open-label, dose escalation study. MSI-1436 will be administered as a~     single intravenous infusion twice a week for 3 weeks on a 4-week cycle.~   "
79608|NCT02524938|"~     Type 2 diabetes mellitus (T2DM) is associated with an increased risk of kidney failure, with~     high levels of glycohaemoglobin (HbA1c) presenting a sharper decline in renal function and an~     increase in the risk of mortality and end-stage renal disease (ESRD). Polyphenols may improve~     renal insufficiency in patients with diabetes with chlorogenic acids (CGA) one of the~     principle polyphenol groups in the diet - coffee/tea, stone fruits (especially plums/prunes)~     and some vegetables (artichoke, chicory). CGA (3-4 cups of coffee) has been associated with~     25% lower risk of T2DM and a favourable reduction of HbA1c, blood pressure, and oxidative~     stress levels. This randomised controlled trial, therefore, aims to evaluate the effect of~     high CGA food on glycation and oxidative stress in T2DM subjects with early renal~     insufficiency (glomerular filtration rate of 35-60 mL/min) as well as progression of renal~     insufficiency and the risk of cardiovascular diseases.~      The study will have two phases - phase I, an interventional study of 3 months followed by~     phase II, an observational study of 21 months.~      In phase I, subjects will be randomized into 2 groups: CGA-enriched diet group, or control~     (habitual) diet group. The treatment group will be provided with a chlorogenic acid-rich food~     (coffee) with instructions to achieve an intake of 400 mg per day (equivalent to 3-4 coffee~     cups per day) for 12 weeks. The control group will receive a conventional coffee low in~     chlorogenic acid.~      Participants will attend three sessions during phase I; baseline, 6 weeks, and 12 weeks. At~     baseline, general information, medical history, dietary habits and medication use will be~     recorded and a Food Frequency Questionnaire completed. Urine and blood samples will be~     collected and blood pressure, waist circumference, height and weight recorded. Participants'~     diet over the previous 3 days will be assessed by estimated food diary analysis.~      In phase II, written dietary recommendations will be provided at three time points (months 6,~     12 and 24) - treatment group to achieve a CGA-rich diet (total polyphenol intake of at least~     1g per day, and at least 400mg per day of CGA) and standard dietary advice for the control~     group. Anthropometric/dietary data will be collected as well as blood and urine samples to~     assess markers of renal function, glycation and oxidative stress, and proteomic markers of~     cardiovascular disease, coronary artery disease and diabetes.~   "
79609|NCT02524925|"~     A prospective randomized clinical study, with cross-sectional comparisons and correlations~     was conducted from May 2012 to July 2015 with a sample of 231 patients who have undergone~     hepatectomy or pancreatectomy, randomized into 2 groups. In group A was applied~     postoperatively the protocol Fast-track, while in group B the conventional postoperative~     care. Demographic and clinical data were collected. In 170 patients, Neuropeptide Y (NPY),~     Adrenocorticotropic hormone (ACTH)/Cortisol plasma levels were measured by ELISA method: a)~     at the day of patient's admission, b) the operation day, c) the 3rd postoperative day or~     prior to discharge.~   "
79610|NCT02524912|"~     Methadone maintenance treatment (MMT) has been one of the most effective treatment choices~     for opioid addicts to reduce their heroin use, criminality and spread of HIV. In Taiwan, MMT~     has been introduced since 2006. To date, more than 30,000 opioid addicts have ever~     participated in MMT, but only around 10,000 retains in treatment. Outcomes of the~     ever-treated MMT patients remain unclear. It is crucial to trace the opioid addicts'~     treatment career, outcomes and unmet treatment needs for the service providers to modify~     treatment strategy to help these individual to maintain abstinence. Moreover, understanding~     of the determinants for these subjects' long-term outcomes is important for policy makers to~     implement realistic policies to motivate the service providers and patients.~      From the results of previous research, the research team found that early dropout, defined as~     stayed in-treatment less than one month, of MMT participants were 14.4%. The rate of~     maintaining in treatment at 3rd , 6th, and 12th month were 65.7%、51.3% and 33.8%,~     respectively. Average treatment days for 12-month is 186.9±141.2. This result showed that the~     effectiveness of the MMT was varied among different facilities. On the other hand, the~     quality of the MMT can be improved largely through different dimensions. Besides, if one~     participant can enhance its motivation in staying in-treatment, it could reduce 15% early~     dropout. Above all, the result also showed that though the quality of life was recorded as~     improved after MMT, it appeared to be significantly lower than their healthy counterparties.~     The assessments of health outcomes after participating MMT are rare, but in need. It is~     necessary to make some modification to improve the effectiveness. Moreover, the evaluation of~     the needs shall not limit to patients, but also extend to their family members.~      Therefore, in this study, the research team plans to probe the dimensions from physical,~     psychiatric, to social conditions by assessing patients and their family members after~     treated by MMT for five years. The research team would like to know more about the outcomes~     of those who attended MMT five years ago, their physical and mental health conditions, also~     health status of their family members.~   "
79718|NCT02523495|"~     Through clinical observation and data statistics, conclude the clinical outcome of target~     therapy in metastasis colorectal cancer and explore some biomarkers that relate to target~     therapy.~   "
79612|NCT02524886|"~     Rationale: Tardive dyskinesia and dystonia (TDD) are severe side effects of dopamine blocking~     agents, particularly antipsychotics. Deep brain stimulation (DBS) has shown to be effective~     in the treatment of TDD in psychiatric patients, but only reported in case reports and small~     clinical trials and with little attention to possible psychiatric or cognitive complications~     or positive effect on psychiatric symptoms.~      Objective: To assess whether treatment with DBS can reduce or resolve TDD and if DBS can~     induce beneficial or side-effects in particular psychiatric symptoms.~      Study design: A delayed onset double blind randomised controlled trial. Study population:~     Adult patients with a current or previous psychiatric disorder and antipsychotic induced TDD~     with a stable psychiatric status during the past 6 months.~      Intervention: All patients will be treated with DBS in the posteroventrolateral GPi. The~     groups will be randomised into immediate stimulation or delayed stimulation after 3 months.~      Main study parameters/endpoints: Primary objective, improvement on the movement rating scales~     BFMDRS. Secondary objectives improvement on the quality of life measured on the SF-36,~     psychiatric stability as measured on the BPRS and the MADRS and cognitive effects as measured~     on the MATTIS Dementia Rating Scale, Nederlandse Leestest voor Volwassenen (NLV), 15 word~     test, Facial Expression of Emotion S+T (FEEST), Groninger Intelligentie Test woordopnoemen~     (GIT), category and letter fluency test, Trail Making Test part A and B and the Stroop colour~     and word test~   "
79613|NCT02524873|"~     Whether patients with a functional genotype of a protein important in blood pressure~     regulation respond better to a drug therapy class/combination of therapy classes that target~     that specific pathway using the Geneticure panel for high blood pressure~   "
79614|NCT02524860|"~     The purpose of this study is to evaluate the effectiveness of Focal-Fusion Bx at detecting~     clinically significant prostate cancer in a standard clinical environment.~   "
79615|NCT02524847|"~     This is a single-arm, open-label, multicenter study of the efficacy of UVADEX® (methoxsalen)~     Sterile Solution in conjunction with THERAKOS® CELLEX® Photopheresis Systems in pediatric~     patients with steroid-refractory aGvHD. The study is composed of Screening, Treatment, and~     Follow-up Periods.~   "
79616|NCT02524834|"~     This is an early feasibility study that investigates the outcome of selected patients with~     complex thoracoabdominal aortic lesions who are suitable for endovascular (within the vessel)~     repair with a physician-modified Medtronic Thoracic Valiant stent graft. The Medtronic~     Valiant System includes a Valiant Thoracic Stent Graft, a self-expanding, tubular end~     prosthesis which is modified/customized by the Investigators to fit the patient's anatomy.~     The device is constructed by making a taper in the larger proximal thoracic device and~     attaching it to a smaller distal thoracic device. The Viabahn branches for the visceral~     vessels are sutured to holes made in the tapered section. The modified Valiant stent graft is~     advanced to the lesion site endoluminally via the iliac/femoral artery. Access for delivery~     of extensions to the device will be delivered through the left subclavian artery. Upon~     deployment, the stent graft self-expands at the target location, where it is designed to~     exclude the lesion by restoring blood flow through the stent graft lumen.~   "
79617|NCT02524821|"~     The purpose of this study is to determine the effect of Gelesis100 on the absorption of~     metformin both with and without a meal.~   "
79618|NCT02524808|"~     This is an observational prospective study. Patients diagnosed with advanced epithelial~     ovarian cancer (stage IC or higher) since 2008 will be asked to participate in this study by~     signing an informed consent. Tumour samples will be reviewed to confirm the diagnosis and to~     select the best regions for tissue sampling to perform the following molecular studies:~     array-based Comparative Genomic Hybridization and Next Generation Sequencing. Detected~     mutations will be analysed by Sanger sequencing. FISH probes will be designed and tested on~     the samples.~   "
79619|NCT02524795|"~     Omega-3 fatty acids have been considered anti-inflammatory lipids based on data from~     epidemiological studies of Greenland Eskimos whose diet is rich in fish, sources of~     polyunsaturated fatty acids.~      Fatty acids from the omega-3 family [mainly the α-linolenic acid, eicosapentaenoic (EPA) and~     docosahexaenoic (DHA)], as well as those of the omega-6 family [represented mainly by~     linoleic acid and arachidonic acid (AA)] are essential for the synthesis of eicosanoids,~     prostaglandins, leukotrienes, thromboxanes and other oxidative factors, major mediators and~     regulators of inflammation.~      Systemic lupus erythematosus (SLE) is an inflammatory autoimmune disease characterized by the~     loss of balance of cellular immunoregulation and increased levels of circulating inflammatory~     mediators.Thus, omega-3 supplementation could represent additional therapy for individuals~     with SLE.~      The aim of this study was to investigate the effects of omega-3 fatty acids on circulating~     levels of inflammatory and biochemical markers in women with SLE.~   "
79620|NCT02524782|"~     A Phase 1, combined Single Ascending Dose (SAD) and Multiple-ascending Dose (MAD) study to~     evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of~     MEDI4166 in Subjects with Type 2 Diabetes Mellitus (T2D).~   "
79621|NCT02524769|"~     The medical field is beginning to adopt treatments that alter an individual's microbiome to~     improve patient health; however, this approach has not been adopted for treatment of lower~     urinary tract symptoms (LUTS). Here, the investigators propose the first step in development~     of such a therapy. If the investigators hypothesis is correct, the investigators could change~     the first line of treatment for hypoestrogenic women and develop future therapies that~     modulate bacteria in the bladder to improve not only LUTS but also treatment response. This~     could lead to the first treatment for lower urinary disorders that incorporates a person's~     individual microbiome.~   "
79634|NCT02524600|"~     Cardiological examination is one of the major directions in nuclear medicine for detection of~     myocardial ischemia in patients with suspected coronary artery disease. In Caen, they~     constitute 20% of the activity of nuclear medicine. It is evaluating a new versatile~     innovative technology (IQ-SPECT) for performing rapid nuclear cardiological examinations (4~     minutes) and quality on a SCINTI-CT camera for correcting the mitigation. This technical~     solution IQ-SPECT was made available to the nuclear medicine department in August 2011. To~     date, apart from the work on heart ghosts and one publication in abstract form in 2009, no~     other study have been published.~      The goal of the study is to study the technical performance of the innovative technology~     IQ-SPECT during a SCINTI-CT imaging in patients suspected of coronary disease .~   "
79622|NCT02524756|"~     The aim of this study is to assess:~        1. Evaluation of the feasibility of laparoscopic nerve sparing radical hysterectomy type~          III/C1 as regard surgical technique, blood loss and operative time.~        2. Evaluate patients' outcome as regard bladder function.~      in order to preserve the function of the bladder and the rectum, it is necessary to modify~     the traditional procedures, so as to identify the precise anatomical information directing~     the technique for optimal preservation of bladder function at the time of radical~     hysterectomy.~      The laparoscopic technique offers several well-known advantages. Under the magnified view of~     the laparoscope, the anatomy can be clearly visualized to allow for the meticulous and~     precise dissection of the para-cervical structures and areolar tissue, including the blood~     vessels and the nerves.~      Laparoscopic identification (neurolysis) of the inferior hypogastric nerve and inferior~     hypogastric plexus is a feasible procedure for trained laparoscopic surgeons who have a good~     knowledge not only of the retroperitoneal anatomy but also of the pelvic neuro-anatomy as~     this qualification could prohibit long-term bladder and voiding dysfunction during~     nerve-sparing radical hysterectomy~   "
79623|NCT02524743|"~     The purpose of this study is to determine whether efficacy of different doses of lidocain and~     acetaminophen for the prevention of rocuronium injection pain and frequency of withdrawal~     movements during the general anesthesia induction period.~   "
79624|NCT02524730|"~     The purpose of this study is to collect basic function, radiographic and patient satisfaction~     data for observation and analysis.~   "
79625|NCT02524717|"~     The purpose of this study is to characterize the pharmacokinetics of JNJ-56021927 in~     participants with mild and moderate hepatic impairment.~   "
79626|NCT02524704|"~     The goal of this feasibility study is to evaluate the ability of Electrical Impedance~     Tomography (EIT) for providing regional and quantitative information about the extent and~     nature of bronchial obstruction in patients with cystic fibrosis. It is not being conducted~     to diagnose, treat, prevent, or cure any kind of disease. In electrical impedance tomography~     low amplitude, low frequency current is applied on electrodes, and the resulting voltage is~     measured and used to computed the electrical properties of the interior of the chest as they~     change in time. The computed properties are used to form an image, which can then be used for~     monitoring and diagnosis.~   "
79627|NCT02524691|"~     The study is designed to establish the level of agreement between the ROM Plus test and the~     diagnosis of ROM as defined by the patient's clinical course, with respect to a population of~     pregnant women who present to the clinical site with signs and symptoms suggestive of ROM.~   "
79628|NCT02524678|"~     The purpose of this study is to assess the safety, tolerability, PK and PD of URC102 in~     healthy subjects.~   "
79629|NCT02524665|"~     One of the main success factors in acne therapy is user compliance with treatment, product~     cost, availability and ease of use. Poor compliance may translate into decreased efficacy~     (either not improving symptoms well enough or not improving symptoms fast enough),~     tolerability issues or adverse effects (eg, erythema, dryness, or peeling of the skin), a~     lack of understanding of the instructions for use, or product cost/availability. Whatever the~     reason, poor compliance translates to decreased efficacy and increased frustration on the~     part of the user.~      The current study will evaluate and compare the efficacy and tolerability of 2 over the~     counter, topical product lines for the treatment of acne: MAXCLARITY II Foam Cleanser (2.5%~     benzoyl peroxide [BPO]) plus Foam Treatment (2.5% BPO) and (0.5% Salicylic Acid) Toner Foam~     compared with MURAD Clarifying Cleanser (1.5% salicylic acid [SA]) plus Exfoliating Acne~     Treatment Gel (1% SA) and Skin Perfecting Lotion.~   "
79630|NCT02524652|"~     Early rehabilitation after anterior cruciate ligament reconstruction is of paramount~     importance and requires optimal pain control based on a multimodal concept, including~     injection of local anaesthetics. Regarding this latter, different options have emerged~     recently such as the adductor canal block, performed before the surgery by the~     anaesthesiologist or the infiltration of the articulation performed by the surgeon at the of~     the intervention. No trial has compared these two approaches. As practice of medicine should~     be based on evidence, we decided to undertake this randomised controlled trial where we~     compared the adductor canal block with the local infiltration analgesia technique in terms of~     pain and functional outcomes~   "
79631|NCT02524639|"~     The purpose of this pilot study is to generate data to assess feasibility of study~     design/procedures and for formal sample size estimation for a larger multicenter study of the~     efficacy and safety of sirolimus in infants with medically-unresponsive congenital~     hyperinsulinism (HI) due to inactivating mutations of adenosine triphosphate-sensitive~     potassium (KATP) channels.~   "
79632|NCT02524626|"~     Hypothesis:~      Electrical stimulation of the abdominal vagus nerve has anti-inflammatory effects which lead~     to a faster postoperative recovery after abdominal surgery.~      Aims:~      In the present study, the investigators want evaluate the anti-inflammatory effect of~     peroperative electrical stimulation of the vagus nerve. In addition, the investigators want~     to determine whether vagus nerve stimulation leads to a faster postoperative recovery. To~     this end, the following aims are formulated:~        1. to determine whether vagus nerve stimulation leads to an improvement in gastrointestinal~          transit using radiological testing~        2. to evaluate whether electrical stimulation of the vagus nerve leads to clinical~          improvement (daily questionnaire)~        3. to show that electrical stimulation of the intra-abdominal vagus nerve reduces the~          inflammatory response to abdominal surgery~   "
79633|NCT02524613|"~     Bone marrow biopsy is a frequently performed procedure to diagnose and evaluate hematologic~     diseases. It is estimated that over 700,000 bone marrow procedures (BMP's) are performed~     annually in the U.S. Most of them are performed by practicing hematologists/oncologists in~     their offices or hospitals. However, a significant number are performed by~     hematologists-in-training (H-I-T's) in teaching hospitals. However, the incidences of~     complications associated with bone marrow biopsy are largely unknown. This study has two~     goals:~        1. The first goal is to objectively determine by CT and clinical assessment, the actual~          risk to patients of the bone marrow biopsy and the rate of pelvic injury in an~          unselected group of hematology patients requiring a bone marrow biopsy, as performed by~          hematologist-in-training.~        2. The second goal is to determine the quality of bone marrow biopsies obtained, using the~          lateral angulation technique.~   "
79635|NCT02524587|"~     The total hip replacement, with over 120,000 cases per year in France, provides short term,~     excellent functional results and a significant improvement in quality of life, in almost all~     cases. However, the observation has shown that the lifetime of the implants is limited due to~     aseptic loosening. One of the factors associated with these failures is a peri-prosthetic~     osteolysis wherein the polyethylene wear debris (PE) have been implicated. Several solutions~     have been proposed: change the friction torque (hard-hard pairs using ceramic or metal on the~     two components of the couple) or improving quality polyethylene. Improving the resistance of~     polyethylene wear is the primary objective evaluated in this study.~   "
79636|NCT02524574|"~     In patients with heart failure, the drive to the effort has demonstrated its safety and its~     interest. Patients with heart failure, endothelium-dependent peripheral vasodilatation is~     impaired by decreased activity of endothelial NO synthase. The rehabilitation training~     significantly improves peripheral endothelial function, and this improvement is correlated to~     the increase in exercise capacity. The impact on coronary endothelial function remains poorly~     documented, especially in non-ischemic dilated heart disease.~      The main objective of this study is to investigate the effectiveness of cardiac~     rehabilitation on the restoration of coronary endothelial function in cardiac failure patient~     evaluated with Tomography Positron Emission 15O-H2O.~   "
79637|NCT02524561|"~     Combined estrogen and progestin therapy has been shown to increase mammographic density and~     incidence of breast cancer in randomized trials. The investigators propose to examine the~     effects of now commonly used low-dose combined hormone therapy (HT) regimens on breast~     density, rates of abnormal mammogram, and circulating estrogens in the ongoing,~     already-funded Kronos Early Estrogen Prevention Study (KEEPS). KEEPS is a randomized clinical~     trial with a primary goal of examining the effects of low-dose transdermal versus oral~     estrogen combined with cyclic micronized progesterone on progression of subclinical~     atherosclerosis in recently menopausal women. Prior studies of low-dose HT have been of short~     duration and small size. By determining the effects of low-dose hormone therapy on the~     breast, the proposed ancillary study will add important information about the estimated~     balance of risks and benefits associated with low-dose HT and will help guide future research~     trials.~   "
79638|NCT02524548|"~     The purpose of this study is to determine whether weekly SMS reminders are effective in~     improving medication adherence of adjuvant aromatase inhibitors in women with breast cancer.~   "
79639|NCT02524535|"~     Regardless of age, the quality of hospital care, the confidence that the young can have in~     the health care team, joining parents are pivotal elements and influence followed. Family~     support is all the more important as 14% of young people realize a new suicidal act within~     three months of hospitalization for attempted suicide, and that the essential predictors~     appear to be the young age and quality of intra-family relationships.~      The main objective of this study is to determine, through the construction of an instrument~     to quantify the therapeutic alliance, defined by the characteristics of the mobilization of~     the entourage and the mutual commitments in the care of nursing teams and the entourage, the~     role of early therapeutic alliance with the entourage of suicidal youth 13-40 years, whether~     primosuicidants or repeat offenders, on short and medium term recurrences and early~     mortality.~   "
79640|NCT02524522|"~     This study evaluates the influence of alveolar recruitment maneuver, protocolized liberation~     from respiratory support and monitoring of Integrated Pulmonary Index on the duration of the~     mechanical ventilation and the number of pulmonary complications in the early postoperative~     period after cardiac surgery.~   "
79641|NCT02524509|"~     The purpose of this study is to evaluate safety and efficacy of Chondron(autologous cultured~     Chondrocyte) by comparing between Chondron implantation and Microfracture.~   "
79642|NCT02524496|"~     Due to the lack of other drugs to treat gastroparesis Janssen and FDA approved the~     compassionate use of cisapride to treat patients who had no other effective therapy. For this~     observational study, 3 patients who had already been prescribed cisapride by outside~     physicians, were followed to determine the effectiveness of cisapride on their gastric~     emtpying.~   "
79643|NCT02524483|"~     Background: Outcomes from the investigators' recent exploratory investigation suggested that~     a high dosage of challenging physical therapy exercises can result in clinically relevant~     improvements in the postural balance and walking speed of individuals with MS.~      Objective: The investigators anticipated that the promising results were due to the novel~     challenging postural balance and mobility exercises. The purpose of this investigation was to~     test this notion by evaluating the mobility and postural balance improvements that could be~     achieved in a cohort of individuals with MS who participated in a therapeutic protocol that~     consisted of activity based exercises, and a cohort of individuals with MS that participated~     in the challenging physical therapy protocol.~   "
79644|NCT02524470|"~     To assess the feasibility and usability of the Vital Signs Patch (VSP) System in the~     in-patient hospital setting to monitor vital signs using a patch, brain, gateway, and~     console. The VSP System will be incorporated into the study site's Information Technology~     infrastructure.~   "
79645|NCT02524457|"~     The purpose of the study is to describe the molecular mechanisms related to an increased~     visceral fat mass and changed T-cell homeostasis. the project is expected to add new~     knowledge to the field of metabolic diseases after menopause and increase the focus of how~     lipid affects the development of metabolic disease in relation to the menopausal transition.~   "
79646|NCT02524444|"~     Randomized controlled single blind prospective comparative study.~   "
79647|NCT02524431|"~     The purpose of this study is to try to identify the cause of damage to the drainage system of~     the eye (the trabecular meshwork). Damage to this system may cause elevation in the pressure~     within the eye and thereby damage to the optic nerve and the vision.~   "
79648|NCT02524418|"~     This is a prospective evaluation of the clinical utility of the new cholangioscopy platform~     SpyGlass DS. The aims of this study are to prospectively document the clinical utility and~     technical aspects of ERCP with cholangioscopy and/or pancreatoscopy in the diagnosis and~     management of pancreatic-biliary disorders.~   "
79668|NCT02524145|"~     The purpose of this study is to determine the mechanisms of chronotropic incompetence~     (inability to increase heart rate with exercise) in patients with heart failure and preserved~     ejection fraction (HFpEF). The investigators will test both central command regulation and~     cardiac beta-receptor sensitivity over control of heart rate.~   "
79649|NCT02524405|"~     The main objectives for this study are:~        1. To investigate novel, non-invasive ocular measurements including optical coherence~          tomography and eye tracking in a cross-sectional study of participants with various~          neurodegenerative dementias against standard cognitive assessments and brain imaging~          measures; and~        2. To assess the potential utility of ocular assessments for early detection in the~          pre-dementia, i.e. the so-called Mild Cognitive Impairment (MCI) stage, across the~          common neurodegenerative dementia syndromes and, Vascular Cognitive Impairment (VCI) due~          to small vessel disease (SVD).~        3. To determine the prevalence and relevance of amyloid uptake on PET scanning across the~          dementias most commonly associated with amyloidosis. Specifically we aim to examine~          correlations with amyloid uptake status in patients symptomatic from the most common~          proteinopathies (ie amyloid, tau, synuclein) combined in varying degrees with the most~          common vasculopathies (ie small vessel disease) using multimodal structural and~          functional imaging, cognitive behavioral, and gait and balance measures, taking into~          account genetic risk markers (particularly apolipoprotein E genotypes) and fluid~          biomarkers ( eg cytokines, oxidative stress, lipidomics).~   "
79650|NCT02524392|"~     A randomized controlled trial comparing independent medical evaluation (IME) to treatment as~     usual (TAU). Participants will be individuals reaching six months uninterrupted sickness~     absence. Treatment as usual (TAU) is normal follow-up by a general practitioner (GP).~   "
79651|NCT02524379|"~     The purpose of this study is to determine the safety of using oral Glyburide (DiaBeta) in~     patients with acute traumatic cervical spinal cord injuries (SCI).~   "
79652|NCT02524366|"~     We propose a randomized non-blinded comparison of standard vs. transcorporal approach for~     placement of an artificial urinary sphincter in male patients with stress urinary~     incontinence after radiation and radical prostatectomy for prostate cancer. In the United~     States, the artificial urinary sphincter (AUS), manufactured by American Medical Systems, is~     the gold standard surgical treatment for stress urinary incontinence (SUI) in men. The cuff,~     which is the portion of the device that encircles and occludes the urethra, is typically~     placed directly around the urethra (i.e., standard placement). The cuff can erode into the~     urethra. Transcorporal placement has been introduced as a method to reduce the risk of~     erosion. Transcorporal placement involves tunneling the cuff through the erectile bodies so~     as to protect the dorsal aspect of the urethra. This approach has never been compared to~     standard placement in a randomized fashion. In our randomized trial, no additional procedures~     beyond the normal care protocol will be required of the patients. We will conduct the study~     through our established, IRB-approved multi-institutional network of surgeons. Success will~     be assessed via objective and subjective methods; complications will be tallied in a~     standardized fashion. Outcomes will be measured at two years.~   "
79653|NCT02524353|"~     Countless studies are performed to quantify the severity of heart disease and its influence~     on the respiratory system, checking that their heart conditions and the surgical process~     determine pulmonary complications, one of the most common causes of morbidity and mortality~     in the postoperative period of cardiac surgery . After surgical procedures, there is a~     reduction of the residual volume (RV), total lung capacity (TLC), vital capacity (VC) and~     functional residual capacity (FRC), leading to the formation of atelectasis, with alterations~     in the ventilation-perfusion ( V / Q), the partial pressure of carbon dioxide in arterial~     blood (PaCO2) and partial pressure of oxygen in arterial blood (PaO 2).~      Pulmonary function is impaired in the postoperative period of cardiac surgery, due to various~     factors common to this major surgery that will drive the patient to develop respiratory~     complications such as atelectasis and pneumonia. Physical therapy plays an important role in~     the treatment of patients undergoing cardiac surgery, both in the preoperative period and~     postoperative, in order to prevent or minimize the respiratory complications.~      Follow-up studies on cardiac rehabilitation quantify the quality of all the activities~     necessary to ensure to patients with heart disease patients the best physical , mental and~     social conditions so that consequently they are able , with its effort to regain a normal~     position in the community and lead a active and productive life over time, therefore, the~     clinical changes resulting from an extensive cardiac surgery are already highly dedicated~     described in literature but which daily life factors or rehabilitation interventions that the~     patient will take in the late postoperative period that really assisted in his complete~     recovery and inclusion into society they are still not well elucidated , so it is appropriate~     to carry out this project due to the fact exposed to up.~      The project to be developed whose main justification clarify issues related to the return or~     preservation of the individual feature that undergoes extensive cardiac procedure , as well~     as incidence of mortality after 12 months of the procedure. The current literature does not~     expressed clearly, possible impacts on functionality and return the daily activities of the~     individual in the late postoperative period , since such malfunctions in the immediate post~     operative period are already fully understood.~   "
79654|NCT02524340|"~     The best treatment plan for Juvenile Idiopathic Arthritis (JIA) is often complicated.~     Patients and clinicians often don't know what is the best treatment strategy for a given~     patient at a given time. The purpose of this study is to develop a method to analyze data in~     situations where the treatment and disease state change over time. The researchers will~     develop a web-based package that will use the methods developed in this study. The package~     will be easy to use and allow dissemination of the methods to the public.~   "
79655|NCT02524327|"~     The first aim of this study is to compare two methods of administration of intravenous~     anesthetics to obtain the same level of depth (bispectral index between 40 and 60): manual or~     automated and to determine a mid-term (6 months) influence of the frail phenotype on~     self-sufficient elderly patients after general anesthesia.~   "
79656|NCT02524301|"~     The place of opioid system in anorexia nervosa (AN) physiopathology is still unclear.~     Conflicting results were published on cerebral spinal fluid or peripheral levels in anorexia~     nervosa. However, no data have been reported on opioid cerebral activity. Diprenorphine is a~     ligand with non-selective binding to opiate receptors µ, κ and δ capable to assess the~     interaction between endogenous opioids and their receptors.~   "
79657|NCT02524288|"~     The purpose of this study is to assess the contraceptive efficacy of the Etonogestrel (ENG) +~     17β-Estradiol (E2) vaginal ring in women between 18 and 35 years of age based on the number~     of in-treatment pregnancies as expressed by the Pearl Index (PI). The study will also assess~     the safety and tolerability of the ENG-E2 vaginal ring.~   "
79658|NCT02524275|"~     This phase II trial studies the side effects and how well docetaxel and capecitabine work in~     treating patients with squamous cell (thin, flat cells) carcinoma of the head and neck that~     has come back or spread to others places in the body. Drugs used in chemotherapy, such as~     docetaxel and capecitabine, work in different ways to stop the growth of tumor cells, either~     by killing the cells, by stopping them from dividing, or by stopping them from spreading.~   "
79680|NCT02523989|"~     The purpose of this study is to explore the relationship between arsenic methylation and~     blood metals in children with developmental delays and its correlation with health related~     quality of life.~   "
79659|NCT02524262|"~     Atrophic gastritis with hypochlorhydric milieu is a risk factor for gastric cancer. Microbes~     colonizing the acid-free stomach oxidize ethanol into acetaldehyde, a group 1 carcinogen. The~     aim is to assess gastric production of acetaldehyde and its inert condensation product,~     non-toxic 4-methyltiazolidine-2-carboxylic acid (MTCA), after alcohol intake under treatment~     with slow-release L-cysteine or placebo.~      Patients with biopsy-confirmed atrophic gastritis, low serum pepsinogen and high gastrin-17~     are studied. On separate days, patients will be randomly assigned to receive 200 mg~     slow-release L-cysteine or placebo, then have intragastric instillation of 15% (0.3 g/kg)~     ethanol. After intake, gastric concentrations of acetaldehyde, ethanol, L-cysteine and MTCA~     are analysed for 4 hours.~      Expected results show mitigated exposure of the gastric mucosa to acetaldehyde.~   "
79660|NCT02524249|"~     Caffeine is routinely used in the management of apnea of prematurity. Extremely low birth~     weight (ELBW) infants are at higher risk of mortality and various neonatal morbidities such~     as bronchopulmonary dysplasia (BPD) for which caffeine has been shown to be beneficial in~     very low birth weight (VLBW) infants. The investigators' previous unpublished retrospective~     studies and recently published retrospective studies demonstrated that early caffeine given~     within 48 hours of age tended to decrease the incidence of death and BPD in ELBW newborns.~     Retrospective design can be biased as newborns with mild lung disease may have received~     caffeine early for extubation. There are several studies on pharmacodynamics and~     pharmacokinetics of caffeine. The data regarding cumulative dosage of caffeine, caffeine~     levels and BPD outcome is deficient.~      Primary objective of this study is to test the hypothesis that early caffeine given within 24~     hours of life will decrease incidence of mortality and BPD in ventilated ELBW newborns.~      This study will also test an additional hypothesis that higher caffeine dosage and caffeine~     levels are associated with decreased mortality and postnatal morbidities in studied newborns.~   "
79661|NCT02524236|"~     The primary objective of this study is to compare the efficacy and safety of a single~     injection of 50 U and 100 U doses of BoNT-A for the treatment of BPH-associated LUTS.~   "
79662|NCT02524223|"~     Human PapillomaVirus (HPV) are ones of the main causal agents of sexually transmitted~     diseases. Numerous HPV genotypes such as 16, 18, 31 or 45 are considered to be at high risk~     of oncogenicity especially for the anal and cervical mucosa. At the present time, no~     recommendations exist on the risk related to HPV during Medically Assisted Procreation (MAP)~     procedures. The main objective of this prospective multicentric cohort study is to evaluate~     the prevalence of transmission of HPV via the semen during MAP program. Secondary objectives~     are to evaluate (1) the prevalence of HPV DNA in the sperm fractions of men enrolled in MAP,~     (2) the efficacy of spermatozoal pellet preparation procedures to eliminate HPV, (3) the~     correlation between HPV and male infertility and (4) the correlation between HPV and success~     rate of procreation. Results could contribute to revise guidelines of MAP procedures and HPV~     vaccination policy.~   "
79663|NCT02524210|"~     Dabigatran etexilate is a novel oral anticoagulant. It is indicated in venous thromboembolic~     prevention in orthopedic surgery and has recently shown greater efficiency and tolerance as~     anticoagulants in preventing thromboembolism in atrial fibrillation. However, it increases~     the risk of gastrointestinal bleeding compared to standard treatment (AVK) [3]. In these~     circumstances the risk / benefit of dabigatran could be improved by combining it with gastric~     protectors such as inhibitor drugs proton pump (IPP).~      Investigators want to evaluate the pharmacokinetic and pharmacodynamic effects of~     co-administration of these two IPP (omeprazole, rabeprazole) with dabigatran in healthy~     subjects.~   "
79664|NCT02524197|"~     To assess the safety and tolerability of orally-administered CR845 in patients with~     osteoarthritis (OA) of the hip or knee. The study drug is being tested to reduce OA pain, and~     will be taken twice a day for two weeks, with four different doses (strengths) being tested.~     From screening period to follow up examination, the study is expected to last for up to 38~     days per participant.~   "
79665|NCT02524184|"~     Obesity and metabolic disease result when energy intake consistently exceeds energy~     expenditure. One appealing new target for treatment is the activation of brown adipose tissue~     (BAT), an organ recently found to be functional in adult humans. Brown adipocytes selectively~     express uncoupling protein 1 (UCP1), which renders the inner membrane of mitochondria leaky,~     thereby diverting chemical energy from ATP generation to heat production. Interest in BAT has~     been spurred by the recognition that in addition to classical BAT depots, other~     brown-fat-like cells are present in the subcutaneous white adipose tissue (WAT) in animals~     and also in humans.These cells have structural and functional properties that resemble brown~     adipocytes, and they are referred to as beige or 'brite' (brown-in-white) adipocytes.~     Interestingly, browning of WAT can be induced in animals and humans by physiological stimuli~     such as cold exposure, which increases adrenergic tone, and by exercise, which selectively~     drives WAT browning through irisin, an exercise-induced myokine. In addition b-adrenergic~     drugs and other pharmacological agents,such as prostaglandins, can induce browning of white~     adipose tissue. More recently, one study showed that treatment of C57BL/6 mice with~     phosphodiesterase inhibitor sildenafil (12 mg/kg/d) for 7 d caused 4.6-fold increase in~     uncoupling protein-1 expression and promoted establishment of a brown fat cell-like phenotype~     (browning) of WAT in vivo. Therefore, the investigators hypothesized that sildenafil can~     promote browning of white adipose tissue and improves insulin sensitivity in human adults.~   "
79666|NCT02524171|"~     The purpose of this study is to determine whether Moral Reconation Therapy (MRT) is effective~     for reducing risk of criminal recidivism and improving other health-related outcomes~     (substance use, mental health, housing, and employment problems) among justice-involved~     Veterans entering residential mental health treatment programs in the Department of Veterans~     Affairs (VA).~   "
79667|NCT02524158|"~     Chronic low back pain (CLBP) is a prevalent condition among VA patients, but many current~     treatment options have limited effectiveness. In addition to chronic pain, people with~     chronic low back pain experience increased disability, psychological symptoms such as~     depression, and reduced health-related quality of life. This randomized controlled study will~     examine the impact of yoga therapy for improving function and decreasing pain in VA patients~     with chronic low back pain. Although not every VA patient with chronic low back pain will~     choose to do yoga, it is an inexpensive treatment modality that is increasingly appealing to~     many VA patients. If yoga is effective, it could become an additional low-cost option that~     the VA can offer to better serve Veterans with chronic low back pain.~   "
79669|NCT02524132|"~     In this research project, the investigators addressed if incorporating physical movements~     with preschoolers will help increase their ability to retain concepts learned in preschool~     such as letter, sound and number recognition. Movement plays an important role in the brain.~     Exercise shows many benefits for the brain to help maintain clearer thought, improve memory,~     and increase activity in the brain, especially the areas involved in memory, attention, and~     language. The following research includes an eight week study of the implementation of~     movement breaks with one preschool class, while using another class as a control group.~     During the two weeks of baseline data, data was collected from every student in both groups~     on their letter recognition with both upper and lower case, letter sound identification, and~     number recognition for numbers 0-10. The group that implemented movement breaks had~     three-five minute scheduled times to stop for movement. Data was collected and compared~     between the two groups to find differences in their academic performance.~   "
79670|NCT02524119|"~     The purpose of this study is determine whether the combination therapy with LEE011 and~     chemoembolization in patients with locally advanced Hepatocellular Carcinoma not amenable to~     curative therapies will provide greater efficacy than chemoembolization alone with a~     tolerable safety profile.~   "
79671|NCT02524106|"~     B-HIVE is a Phase 3, double blind, placebo-controlled, randomized, parallel group study,~     designed to compare the efficacy and safety of bococizumab 150 mg subcutaneously every 2~     weeks to bococizumab placebo subcutaneously every 2 weeks for LDL-C lowering in HIV-infected~     subjects.~   "
79672|NCT02524093|"~     Depression and anxiety are common in MS and often go untreated. Even symptoms which do not~     meet the threshold for a psychiatric diagnosis can have a significant impact on quality of~     life. Positive Mental Training (PosMT) is a 12 week programme which aims to help people~     overcome the negative thinking and feelings that come with worry and low mood and become more~     positive, confident and resilient. To find out if Positive Mental Training is helpful in MS~     the investigators are running a randomised controlled trial. The initial study is a pilot~     tiral, the primary function being examination of the feasibility and acceptability of this~     treatment in MS. Though sample size is small and consequently it may not be powered to detect~     a significant change in symptoms in association with the treatment, this will also be~     examined.~   "
79673|NCT02524080|"~     If patients get to optimal level of healthcare directly it will prevent suffering for both~     patients and their relatives and moreover save a lot of resources. In the project Care at~     the right care level (CRC) the Emergency Medical Services (EMS) will triage patients who are~     in need of primary health care to the Primary Care (PC) instead of to the Emergency~     Department (ED). This intervention should be implemented with the same medical safety as with~     traditional care in the ED and the patient and their relatives should experience~     corresponding confidence to the healthcare provider. To prepare this intervention this~     patient group and their care needs have to be identified by a retrospective journal review~     and a guideline has to be developed. To evaluate the patients' and their relatives'~     experience of the intervention, finally interviews will be implemented. This project is~     expected to provide answers whether it is possible to triage non-urgent patients to another~     care level with the same medical safety and that the patients experience the same confidence~     in healthcare. And further it will answer the question, if the care providers around the~     patient manage to collaborate.~   "
79674|NCT02524067|"~     This study examines the effect of an intervention consisting of dynamic circadian light and~     sound therapy, as well as systematic information on sleep pattern, agitated behavior and~     functioning level.~   "
79675|NCT02524054|"~     The purpose of this protocol is to develop and test aerosol furosemide, as a treatment that~     has the potential to significantly improve symptom management and enhance the quality of care~     for patients with intractable dyspnea.~   "
79676|NCT02524041|"~     Based on the evidence that periostin is specifically involved in intra-cortical remodeling~     control, our working hypothesis is that assessment of its concentration in the serum would be~     helpful in identifying patients with severe cortical porosity, a critical parameter in bone~     fragility. Periostin expression by osteoblasts and osteocytes is part of the bone cortical~     response to anabolic stimuli such as mechanical strain or intermittent increase in~     parathyroid hormone. However, it remains unknown whether this expression may participate as~     well to mechanisms that will lead to exaggerated intra-cortical remodeling and subsequent~     bone loss.~      In rare clinical situations in which trans-iliac bone biopsies will be necessary to better~     understand their bone status in addition to densitometry and biological bone markers~     assessment, specific analyses using immune-staining techniques will be performed on the bone~     sample. Data from routine follow-up every six months will be also collected in this specific~     sub-group.~      High resolution peripheral quantitative computerized tomography (HR-pQCT) gives the~     opportunity of performing a virtual bone biopsy providing information on trabecular and~     cortical microarchitecture in vivo. These microarchitectural parameters allow a more accurate~     evaluation of the alteration of the bone structure and therefore of the fracture risk as~     compared to current tools used in clinical practice such as densitometry. However, the~     availability of such HRpQCT facilities is limited and there is on-going development on the~     best way of measuring porosity for example. The definition of a biological profile including~     key proteins such as periostin and sclerostin involved in porosity mechanisms is therefore of~     great interest. A better understanding of the relationship between bone matrix components and~     parathyroid hormone effects also appears as critical. Follow-up of routine evaluation~     parameters reflecting bone status in a subgroup of specific patients could also provide new~     and additional information.~   "
79677|NCT02524028|"~     The fMRI study is a prospective study with the objective of evaluating the effects of the~     autonomic central nervous system on the regulation of heart rate in patients with atrial~     fibrillation (AF). This study will compare a functional MRI (fMRI) scan in patients prior to~     a direct current cardioversion (DCCV) to a second fMRI scan taken post DCCV. In addition,~     this study will compare functional MRI (fMRIs) to a control group of heart healthy,~     age-matched patients who will also receive two fMRI scans spaced about one week apart.~      Our expectation is that at the end of this study, the investigators will have greater insight~     into the role of the central nervous system and more specifically the autonomic nervous~     system in modulating AF. The investigators expect that understanding the interaction between~     the central nervous system and cardiac arrhythmias will lead to the development of novel~     therapies that preserve and restore normal sinus rhythm. This study will serve as a pilot~     study with the goal of obtaining additional grant funding and expanding the study once~     differences in volumes of activation are demonstrated.~   "
79678|NCT02524015|"~     The purpose of this study is to see if a specific physical therapy intervention speeds~     recovery from stroke-related pusher syndrome.~   "
79679|NCT02524002|"~     The goal of the study is to see if the addition of a carbohydrate- and protein-enhanced gel~     during labor speeds labor and reduces the rate of cesarean delivery.~   "
79681|NCT02523976|"~     In this single-center, open-label, no control,prospective clinical trial, a total of 30~     Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL) patients will be~     enrolled. Dasatinib 100 mg per day will be given orally along with combination chemotherapy~     starting day 8 of induction chemotherapy. Dasatinib will be given continuously (if it's~     tolerable) for 2 years since achievement of complete remission (CR) as part of consolidation~     chemotherapy and maintenance therapy.Patients can receive allogeneic hematopoietic stem cell~     transplantation (HSCT) or autologous HSCT whenever possible during their first CR. Otherwise,~     they will finish the consolidation chemotherapy. The purpose of current study is to determine~     the clinical efficacy and tolerability of combination therapy of Dasatinib with multi-agent~     chemotherapy in newly-diagnosed Ph+ ALL.~   "
79682|NCT02523963|"~     The purpose of this study is to identify the effects of family work shop for children with~     developmental delays.~   "
79683|NCT02523950|"~     The purpose of this study is to evaluate the safety and efficacy of staged and combined~     phacoemulsification with intraocular lens implantation and Descemet membrane endothelial~     keratoplasty (DMEK) to treat cataract patients with corneal endothelial dysfunction. Surgical~     and postoperative complications, visual acuity and corneal endothelial cell density are~     evaluated.~   "
79684|NCT02523937|"~     The purpose of the study is to evaluate the performances of Soluble Fibrin assay for~     exclusion of Pulmonary Embolism and Deep Venous Thrombosis. Secondary objectives are to~     determine the threshold value from the ROC curves, the possible interest in the positive~     diagnosis of Venous Thromboembolism (VTE), and to verify the absence of influence of age on~     the SF results.~   "
79685|NCT02523924|"~     This pilot study aims to investigate the diagnostic utility of 18F-DCFPyL, a novel~     low-molecular weight PSMA PET/CT imaging agent, in men with an elevated PSA following radical~     prostatectomy.~   "
79686|NCT02523911|"~     The purpose of this study is to investigate Suprep bowel preparation, with and without the~     anti-gas medication simethicone, in terms of efficacy and patient tolerability in the~     preparation of patients undergoing routine colonoscopy for colorectal cancer screening.~   "
79687|NCT02523898|"~     Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility which~     affects 12-21% of the population.Several studies performed evaluate the possible benefit of~     metformin alone or in combination with clomiphene (CC)as first-line treatment for infertility~     in women with PCOS have reported conflicting results. These conflicting results may be due to~     the presence or absence of insulin resistance(IR).Metformin decreases IR .However there is~     not a single randomized clinical trial with metformin in IR PCOS patients. Therefore, the aim~     of current study is to compare CC with coadministration of metformin and with CC with~     coadministration of placebo in IR PCOS patients to induce ovulation.~   "
79688|NCT02523885|"~     To investigate exposure to nonsteroidal antiinflammatory drugs (NSAIDs) during outpatient~     management at the early stage of community-acquired pneumonia (CAP) requiring hospital~     consultation. Non-interventional observational study.~   "
79689|NCT02523872|"~     The specific aim of this study is to gather data on fluid balance, intravenous medication~     administration, electrolyte balance, and diuretic and dialysis use in patients with acute~     respiratory failure who might benefit from a strategy designed to limit fluid administration.~   "
79690|NCT02523859|"~     This study investigates the use of remimazolam as a sedative/hypnotic in general anesthesia.~     Remimazolam or propofol will be administered together with fentanyl/sufentanil/remifentanil~     as opioid analgesics and a neuromuscular blocker.~      In total, 530 patients will be randomized. This group of 530 patients will be split randomly~     into 2 groups as follows:~      • 106 patients will be randomized to induction with propofol plus fentanyl or sufentanil or~     remifentanil and a neuromuscular blocker. Throughout maintenance, the patients will receive~     propofol and remifentanil until weaning from the mechanical ventilation on the ICU or PACU~     within 24 hours after induction.~      Afterwards, sedation with propofol as study medication has to be ended. If necessary, the~     sedation is to be continued with the hospital's own supplies (propofol or other sedative).~      • 424 patients will be randomized to induction with remimazolam 6.0 mg/kg/hr together with~     fentanyl or sufentanil or remifentanil and a neuromuscular blocker. Throughout maintenance,~     the patients will receive remimazolam and remifentanil until weaning from the mechanical~     ventilation on the ICU or PACU within 24 hours after induction.~      The primary endpoint is successful sedation is defined as a Narcotrend index of 60 or less~     during at least 85% of the maintenance time and no rescue sedative medication administered.~     The maintenance starts at arrival at the operation theater and ends with the completion of~     the last skin suture.~   "
79691|NCT02523846|"~     The purpose of this study is to improve IV-Patient Controlled Analgesia (IV-PCA) technique~     for postoperative analgesia. Investigators are comparing between patient re-education and the~     background morphine infusion among patients who fail to achieve satisfactory analgesia using~     IV-PCA Morphine after laparotomy.~   "
79692|NCT02523833|"~     Hypersensitivity pneumonitis (HP) is a syndrome with variable clinical presentation in which~     lung inflammation is caused by inhalation of specific organic antigens or low molecular~     weight particles in previously sensitized individuals. Systemic symptoms may or may not be~     present. Chronic HP represents the final stage of the disease, caused by prolonged exposure~     to a particular antigen, leading to pulmonary fibrosis. In chronic HP, pulmonary function~     tests (PFTs) commonly present a restrictive ventilatory pattern, with decreased diffusion of~     carbon monoxide (DLCO). Some patients can also have obstructive disorders with expiratory~     flow limitation, due to obstruction of the small airways typically caused by bronchiolar~     involvement in this pathology. However, PFTs are relatively insensitive for detecting small~     airway involvement when there is concomitant interstitial fibrosis. First, conventional PFTs~     may be normal in patients with small airway involvement, since they contribute to less than~     30% of the total airway resistance. In addition, damage to the small airways in HP is~     generally occurring parallel to areas of focal fibrosis - even when small airways are~     involved, these regions can be completely ignored, since they are excluded from ventilation.~     In summary, traditional PFTs are not sufficiently sensitive to detect diffuse small airway~     involvement in these diseases. In these cases, other functional tests, such as forced~     oscillation technique (FOT) and high resolution computer tomography (HRCT) scans of the chest~     with expired studies, could be used for this purpose.~      This will be a cross-sectional study, which will include the following evaluations in 28~     patients with HP recruited from our clinic:~      - Clinical variables: (A) demographic and anthropometric data; (B) Clinical data: Onset of~     symptoms and time of diagnosis~      C) Dyspnea score:~      D) Smoking: * Current or former smoker * Smoking history (number of cigarettes smoked per day~     and for how long);~        -  Spirometry with forced and slow maneuvers before and after bronchodilator (salbutamol);~        -  Plethysmography to measure lung volumes;~        -  Diffusion capacity of carbon monoxide (DLCO);~        -  High-resolution chest CT with expiratory scans;~        -  Six-minute walk test;~        -  Cardio-respiratory test using a maximal incremental treadmill.~        -  Forced oscillation technique (FOT).~   "
79696|NCT02523781|"~     It is known that preeclampsia is a risk factor for cardiovascular diseases, diabetes, chronic~     hypertension, nephropathy and thromboembolism. The study's aim, subsequent to these~     informations, is to help prevent those consequences. Information tools have been known to~     enhance retention of information given orally. The objective of this study is to assess the~     knowledge and satisfaction of women after an episode of preeclampsia after reading an~     explanatory pamphlet on preeclampsia. The investigators also want to change their perception~     on cardiovascular risk, their risk of recurrence and preeclampsia's medium to long-term~     consequences and the ways to prevent them.~   "
79697|NCT02523768|"~     IgA nephropathy (IgAN) is a histologically defined glomerulonephritis (renal biopsy) by the~     presence of deposits immunoglobulin A (IgA) in the renal mesangium (at least 1+) by~     immunofluorescence. The clinic allows excluding secondary forms (10-15%). Recurrence of this~     condition on the renal graft is time-dependent and confirmed in 25 to 50% of 10 years~     post-transplant.~      The primary immunosuppressive induction regimens currently used in kidney transplantation are~     the anti-lymphocyte globulin (GAL) whose main target is human T lymphocytes (ATG, polyclonal)~     and monoclonal anti-CD25 antibodies (α chain of the interleukin receptor 2 in the surface of~     T lymphocytes). Due to their potent and prolonged immunosuppressive properties, the ATG may~     prevent or delay the recurrence on renal transplant.~      The aim of this study was to evaluate the influence of induction therapy (ATG versus~     Basiliximab) in the cumulative incidence at 5 years of (IgAN) recurrence after a first kidney~     transplant.~      This is a prospective, multicenter, randomized, open trial with a follow-up period of 5 years~     old.~      Patients in the ATG arm will receive 5 antilymphocyte globulin infusions Fresenius® (rabbit~     immunoglobulin antilymphocyte human T-Fresenius® said ATG) from Day 0 to Day + 4~     post-transplant (day 0 one dose of 4mg / kg, day 1 one dose of 4mg/kg, day2 one dose of~     4mgkg, day 3 one dose of 3 m/kg and day 4 and one final dose of 3 mg/kg) and the patients in~     the anti-CD25 arm will receive 2 doses of 20 mg of basiliximab (Simulect®) pn day 0 and day 4~     after the graft. The maintenance immunosuppressive therapy is left to the discretion of the~     center.~      The primary endpoint will be the clinical and histological recurrence of IgAN defined by the~     presence of mesangial deposits of IgA (at least 1) by immunofluorescence on a biopsy of the~     graft triggered by the onset of proteinuria 1g/j and/or microalbuminuria greater than 300 mg~     / day.~   "
79698|NCT02523755|"~     With an efficient epidural analgesia the physiological effects of pain are disabled during~     labor. Pain may cause an increase of minute volume, oxygen consumption and a decrease of~     paCO2 (Arterial CO2 pressure). The study will evaluate the lung function before and after~     labor with and without epidural analgesia. With more efficient breathing, the occurence of~     atelectasis should be reduced; this effect will be investigated in these settings for the~     first time with the electrical impedance tomography, which is a completely non-invasive~     measure.~   "
79699|NCT02523742|"~     Recently, we have shown functional resonance imaging (fMRI) that variations in signal induced~     by a language task were significantly lower in a semantic region of the left hemisphere~     (comprised of that part pars triangularis of the inferior frontal gyrus and the temporal gyri~     medium and angular) in schizophrenic patients compared with controls matched for age, sex,~     level of education and handedness.~      Investigators wish to test the hypothesis that functional modification of the hemispherical~     specialization is specific language and also specific for schizophrenia.~   "
79700|NCT02523729|"~     Human milk is the most optimal food to provide all infants' needs before eating solid food.~     However, underproduction of milk is a common and concerned problem for breastfeeding women.~     In this case, proper milk-making foods reveal their importance on lactation. In many European~     countries, ancient wisdom clams that non-alcoholic malt beverage could facilitate the~     secretion of breast milk. This study estimates the effects of non-alcoholic malt product~     during first three months of lactation.~   "
79701|NCT02523716|"~     To determine if exposure of older volunteers, age 50-70y, who are healthy, but not physically~     active, to 7 days of mild hypoxia (15% oxygen, equivalent 2440m) will improve cardiopulmonary~     functional capacity.~   "
79702|NCT02523703|"~     Multiple sclerosis (MS) is an inflammatory disease of the central nervous system, beginning~     most often in subjects aged 20-40 years. In France, thanks to recent studies reported during~     general states of MS in 2006, the prevalence is estimated at 65.5 / 100,000 population (96.3~     / 100,000 women and 41.9 / 100,000 men) and incidence at 7.91 per 100,000. In Lower Normandy,~     the incidence of MS is estimated to 4.45 / 100,000 inhabitants or 60 new cases per year.~      The primary objective of this pilot study is to assess the levels of glutamate and aspartate~     (excitotoxicity markers) and their repercussions on the clinical and radiological outcome in~     40 patients experiencing an event demyelinating central nervous system.~   "
79703|NCT02523690|"~     ICU acquired muscle weakness is a significant problem in patients recovering from critical~     illness. This trial will evaluate the safety and efficacy of a drug in improving muscle~     weakness in critically ill patients.~   "
79704|NCT02523677|"~     The purpose of this study is to examine relationships among lifestyle behaviors (i.e.,~     physical activity, sleep), cognitive function (i.e., memory, processing speed, and executive~     function), and quality of life in breast cancer patients and survivors across time. The~     investigators will compare the strength of these relationships across age cohorts and time~     since treatment and diagnosis. Participants will complete a battery of questionnaires and a~     set of cognitive tests on an iPad app specifically tailored for this study. A subset of~     participants will also wear an accelerometer for seven days. Data will be collected at~     baseline and 6-month follow-up.~      This research is critical to identifying potentially important approaches to improving health~     outcomes and quality of life in breast cancer patients and survivors. Previous research~     provides evidence of the influence of lifestyle behaviors on cognition and quality of life in~     healthy aging populations. However, despite data indicating cancer's negative impact on~     lifestyle behaviors, cognition, and quality of life, very few studies have investigated~     interactions among these factors in cancer patients and survivors.~   "
79705|NCT02523664|"~     To investigate which neuronal correlates underlie cortisol-induced enhancement of memory~     retrieval in PTSD and BPD.~   "
79706|NCT02523651|"~     The purpose of this study is to evaluate the safety of clinical injection of allogeneic human~     dental pulp stem cell(DPSC) in local infected periodontal tissue and determine whether~     injection of allogeneic DPSC is a effective way in the treatment of chronic periodontal~     disease.~   "
79719|NCT02523482|"~     The study objectives are: to validate the subsets of Screening Tool of Older People's~     Prescriptions (STOPP) and Screening Tool to Alert Right Treatment (START), or STOPP/START~     criteria, and Beers criteria applicable to HAD by comparing their performance when applied to~     clinical and HAD for the same patients, and, using clinical data, to compare the performance~     of the full STOPP/START and full Beers criteria with each other.~   "
79720|NCT02523469|"~     The purpose of the study is to define the safety and tolerability of this drug combination.~     The study will also define the response rate of patients with advanced and unresectable~     NSCLC.~   "
79707|NCT02523638|"~     Polycythemia Vera (PV) is a disease of bone marrow stem cells that manifests in a drastic~     increase of red blood cells and frequently also of white blood cells. The thickening of the~     blood in relation with a modified function of the cells has several consequences like~     increased blood pressure, pruritus of the skin, fatigue, disturbed blood circulation in the~     brain as well as fingers and toes and an increased risk of arterial and venous thrombosis~     (thrombosis is the formation of a blood clot in a vessel); like stroke, cardiac infarction,~     deep vein thrombosis in the legs. In case of a strong increase of platelets there is an~     additional risk of bleedings. As the disease progresses the size of spleen and liver~     increased in most cases and the bone marrow shows signs of fibrosis. In some cases of PV a~     progression at a later time point to a leukemia (increased formation of white blood cells)~     can occur.~      The aim of this study is to assess the ease of AOP2014 self-administration using dedicated~     questionnaires.~        -  To assess safety and tolerability: adverse events (AEs), laboratory parameters,~          electrocardiogram (ECG) throughout study.~        -  To assess maintenance of the blood efficacy parameters Hct (Hematocrit), WBC (white~          blood cells) and PLTs (platelets) and spleen size (comparing values at Visit P7 vs.~          values at Visit P1).~        -  To assess the feasibility of AOP2014 self-administration: defined as the ability of the~          patients to use the pen as a self-administration tool (ease of handling, safety,~          tolerability and efficacy).~   "
79708|NCT02523625|"~     Giant cell arteritis (GCA) is an inflammatory disease causing new, unaccustomed headache in~     the elderly and which can lead to blindness in 20-30% of untreated cases. The study group~     have previously shown that ultrasound is a viable non-invasive alternative to temporal artery~     biopsy in diagnosing GCA. However, there is significant variation in ultrasound assessment~     (measuring a dark halo around the abnormal blood vessels) between sonographers in different~     centres, requiring a labour intensive and time consuming training programme. The study group~     propose to standardise the training programme, and use ultrasound and clinical evaluation to~     define changes occurring over time and with treatment in patients with a diagnosis of GCA~     made based on ultrasound changes alone. The study group will explore the use of algorithms to~     automate or semi-automate image interpretation.~   "
79709|NCT02523612|"~     Routine screening mammography has increased the non-palpable suspicious lesion detection~     rate, requiring histopathological evaluation. The discovery of atypical lesions on the breast~     biopsy is associated with two interrelated risks:~        1. The risk of underestimating the severity of the lesion biopsied currently leads~          systematically to achieve a surgical resection for these patients while a breast cancer~          (BC) will finally identified at surgery in 10 to 25% of cases. Thus, unnecessary~          surgeries will be performed in 75 to 90% of cases (no cancer).~        2. These breast lesions confer long-term increase in the subsequent risk of breast cancer~          (cumulative incidence of 15 to 25% at 25 years). Thus, women identified with atypical~          lesions are then followed using clinical and mammographic annual evaluation.~      The goal would be to get a model to assess the risk and no longer operate those patients at~     high risk of BC. Several groups have attempted to identify predictors of concurrent or~     secondary BC associated with the discovery of an unusual lesion at biopsy. However, they are~     often focused on a subtype of atypia (eg atypical metaplasia, atypical ductal hyperplasia,~     atypical lobular hyperplasia) and no prediction model has been validated in prospective~     multicenter. Based on a large retrospective study at Gustave Roussy, a prediction model~     (Nomat) has been developed, common to all atypical lesions, which can predict the presence of~     a BC at excision surgery (risk of concurrent BC). This model is based on the age of the~     patient, the disappearance of radiographic abnormalities (microcalcifications in general)~     after the biopsy and initial radiological lesion size. This model has good performance with~     an area under the curve (AUC) of 0.72. In previous series, with a BC high-risk threshold of~     20%, negative predictive value was 90%, and this model would have prevented the surgery in~     51% of patients (low risk patients by model). It is essential to validate this model by~     forward-looking and in different centers to ensure its relevance.~      This is a multicenter prospective validation of the model on 300 patients operated for~     atypical lesions in 21 centers. All patients with atypical breast lesions have a routine~     surgery. The clinical data, imaging and histological data will be collected prospectively.~     The main objective of this study is to validate the model Nomat.~   "
79710|NCT02523599|"~     This is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled~     efficacy and safety study of postoperative pain in adults who are scheduled for unilateral~     inguinal hernioplasty via open laparotomy (tension-free technique).~      Patients will assess their postoperative pain intensity (PI) using an 11-point numerical~     rating scale (NRS) from 0 hour through 72 hours postoperatively.~      The expected maximum study duration for each patient will be up to 60 days, including a~     maximum 30-day screening period, the day of surgery and implantation, and a 30-day post~     implantation period including treatment and follow-up.~   "
79711|NCT02523586|"~     The intent of this study is to determine the difference in pharyngeal oxygen concentration in~     patients who have a natural airway (not intubated) using commonly available oxygen delivery~     systems.~      The investigators will test the hypothesis that oxygen concentration during the period of~     inspiration (FiO2) in the pharynx is dependent on oxygen delivery system design, even at high~     flow (15 liters/minute) oxygen delivery. Specific measurements include oxygen concentration~     at subjects' lips and pharynx when breathing 100% oxygen and room air via a simple mask,~     non-rebreather mask, OxyMaskTM, and anesthesia mask with headstrap and Jacson Rees circuit.~      A mean difference of 10% pharyngeal FiO2 between any of the masks will be considered~     clinically important. The expected standard deviation of the within-subject FiO2 is 3.5%.~     With a significance criterion of 0.05, 10 subjects would provide more than 90% power to~     detect a mean difference of 10%.~   "
79712|NCT02523573|"~     Bronchoscopy with bronchoalveolar lavage (BAL) is at risk for worsening hypoxemia in patients~     with acute respiratory failure (ARF). High-flow nasal cannula oxygen (HFNC) improves~     hypoxemia in ARF patients . We investigated its efficacy and tolerance in intensive care unit~     patients admitted for ARF requiring BAL.~   "
79713|NCT02523560|"~     Applying modern technology of data collecting, monitoring, transmitting and analyzing in~     order to implement a novel (hybrid) model of comprehensive home-based cardiac rehabilitation~     in heart failure patients.~   "
79714|NCT02523547|"~     Open-labeled, Prospective, Randomized, Multi-center, Interventional, Phase IV study.~   "
79715|NCT02523534|"~     This is an electrogram mapping study that tests the ability of a new signal processing~     technique called electrogram morphology recurrence mapping to locate drivers in participants~     with atrial fibrillation. This study will also test the hypothesis that there are~     non-invasive markers that can predict driver location. Electrogram mapping will be performed~     in participants undergoing ablation for persistent atrial fibrillation. These participants~     will have a cardiac MRI and 12-lead ECG prior to the ablation procedure.~   "
79716|NCT02523521|"~     The purpose of this study is to determine the effects of a physical activity program for~     children with Bronchopulmonary Dysplasia.~   "
79737|NCT02523248|"~     The aim of this randomized control study is to evaluate the effect of tonsillectomy with or~     without uvulopalatoplasty in treating adults with moderate to severe sleep apnea.~   "
79721|NCT02523456|"~     Rationale: Early detection and timely interventions are important determinants of clinical~     outcome in people with acute illness. Adverse outcomes including unplanned transfer to~     intensive care (ICU), cardiac arrest and death are usually preceded by acute physiological~     changes manifesting as alterations in vital signs. Usage of early warning scores (EWS) based~     on bedside vital sign observations may help early detection, improve outcome of patients and~     reduce healthcare cost.~      EWS which are effective in predicting deteriorating patients developed in high income~     countries have been shown to lose sensitivity and specificity when applied to a low income~     setting. It is imperative to explore the usefulness of EWSs in Sri Lanka. If the results are~     positive, widespread adaptation of these scores can significantly contribute to improved~     patient outcome, better utilization of ICU services and cost effective healthcare provision.~      Objectives: To describe the demographic characteristics of cardiac arrest patients and the~     availability of physiological variables for calculation various EWSs in DGH, Moneragala To~     validate an early warning score suitable for patients at DGH, Moneragala To examine the~     effectiveness of the selected EWS at improving pre-defined patient outcomes~      Proposed methodology:~      Study I: All clinical variables and patient characteristics of past two years collected~     retrospectively from BHTs. Vital signs and laboratory measurements 24 and 48 hours before~     cardio respiratory emergency and at admission to hospital will be extracted. The availability~     of variables required for the calculation of various EWSs will be noted.~      Study II: All consecutive inpatient admissions for three months to all units except intensive~     care unit at DGH, Moneragala will be included to the study, prospectively. Data will be~     collected from bed head tickets using pre-defined data sheets by nominated medical/ nursing~     officers daily. Demographic details and physiological data will be recorded on admission to~     ward. Physiological data for seven EWS will be collected twice daily by these medical/nursing~     officers.~      Study III: Training will be given for the staff to identify patients getting worse using the~     newly validated EWS. The outcome of this will be measured with information obtained from~     Study II.~      Ethical clearance obtained from the Ethics review Committee of the Faculty of Medicine,~     University of Colombo (EC-15-034).~   "
79722|NCT02523443|"~     The purpose of this study is to learn whether patient-controlled epidural analgesia (PCEA) is~     a better method for managing pain after liver resection compared to patient-controlled~     analgesia (IV PCA). Currently, the standard pain control method for liver resection patients~     is IV PCA. There is not enough data on how epidural (PCEA) relieves pain and movement on a~     day to day basis after liver resection.~   "
79723|NCT02523430|"~     The purpose of this study is to evaluate the safety and efficacy of HepaSphere interventional~     therapy using digital subtraction angiography（DSA） for nasopharyngeal carcinoma.~   "
79724|NCT02523417|"~     The purpose of this study is to evaluate the safety and efficacy of HepaSphere interventional~     therapy using digital subtraction angiography（DSA）for breast cancer.~   "
79725|NCT02523404|"~     The purpose of this study is to evaluate the safety and efficacy of HepaSphere interventional~     therapy using digital subtraction angiography（DSA）for lung cancer.~   "
79726|NCT02523391|"~     The purpose of this study is to compare the pharmacokinetics of capsule and tablet~     formulations of TA-8995 in healthy male subjects aged 18 to 55 years.~   "
79727|NCT02523378|"~     The goal of this research study is to learn how easy participants think it is to complete a~     symptom questionnaire.~   "
79728|NCT02523365|"~     The purpose of this study is to evaluate the safety and efficacy of HepaSphere interventional~     therapy using digital subtraction angiography（DSA） for cervical carcinoma.~   "
79729|NCT02523352|"~     Aim of this study is to better understand pathophysiology of the alteration of respiratory~     mechanics and cardiovascular function in obese volunteer subjects. The investigators plan to~     test this hypothesis with a physiological, interventional study conducted on volunteers by~     using Electrical Impedance Tomography in a group of patients and magnetic resonance imaging~     (MRI) in another group.~   "
79730|NCT02523339|"~     The purpose of the study is to test if oxygen saturation in retinal vessels is correlated~     with clinical parameters, such as visual acuity, central retinal thickness and presence of~     neovascularization. Retinal oximetry is performed with fundus camera based oximeters. The~     study will not entail change in treatment of the disease.~   "
79731|NCT02523326|"~     Objective The aim of this study was to test a protocol for the extraction of high quality~     genomic DNA from saliva samples obtained with mouthwash and taken from patients with~     periodontal disease.~      Materials and methods Saliva samples were taken from 60 patients, then stored at room~     temperature. DNA extraction was carried out at distinct post-sampling times (10, 20 and 30~     days). Evaluation of genomic DNA was performed with spectrophotometry, electrophoresis, and~     PCR genotyping and sequencing.~   "
79732|NCT02523313|"~     This is a prospective, double-blind placebo-controlled, multicenter, randomized phase II~     trial testing the adjuvant immunotherapy with Nivolumab plus Ipilimumab Placebo or Nivolumab~     plus Ipilimumab versus Double Placebo Control as a post-surgical/post-radiation treatment for~     stage IV melanoma with no evidence of disease (NED).~   "
79733|NCT02523300|"~     To explore the potential prognostic effect of glucocorticoid on the postoperative~     aorta-related adverse events after aortic dissections patients underwent thoracic~     endovascular aortic repair (TEVAR), glucocorticoid (30mg/kg) will be intravenously given~     within 2h after TEVAR.~   "
79734|NCT02523287|"~     The purpose of this protocol is to generate a set of data that will be analysed by integrated~     systems biology approach, for validation in subsequent clinical trials or in animal models.~      240 healthy participants (18-45y) will be enrolled, 228 will be administered a dose of Fluad~     on Day 0, 12 will receive a placebo on Day 0.~   "
79735|NCT02523274|"~     The purpose of this research study is to evaluate the effects of combining physical exercise~     with a resveratrol supplementation on the physical function of older adults.~   "
79736|NCT02523261|"~     Mechanical thrombectomy (TM) is now validated through 4 randomized controlled trials of high~     scientific level as the reference treatment of cerebral infarction associated with proximal~     cerebral occlusion (MR CLEAN, ESCAPE 2014, 2015). These studies have shown for the first time~     a major decrease (-35%) of disability related to severe cerebral infarction and reduction in~     mortality. These studies only used thrombectomy devices called stent retriever for obtaining~     recanalization rates ranging from 58-72% for the 2 largest studies (MR CLEAN, ESCAPE 2014,~     2015). This criterion recanalization is important because it largely determines the~     functional prognosis of patients with severe cerebral infarction (Khatri, 2014).~      These results are exciting but we can do even better. Indeed, already new thrombectomy~     devices are available with a special interest for ADAPT (A Direct Aspiration First Pass~     Technic). This distal suction system, with a high level of endovascular navigability,~     provides high recanalization rates (> 90%), low morbidity, with a synergistic effect with~     stent retriever (Turk A, Kowoll 2014 and 2015). To date, these technic (ADAPT) has never been~     assessed in a randomized controlled trial.~      We have previously conducted a comparative observational study between two recanalization~     strategies by thrombectomy using first-line ADAPT or the most widely used stent retriever.~     The interventional neuroradiologist could, in case of recanalization failure with the~     Solitaire system, used another thrombectomy material left to the operator's choice. 244~     consecutive patients on two centers (Rothschild Foundation, and Foch Hospital, France)~     admitted for a cerebral infarction associated with proximal occlusion were included. This is~     so far the largest series of patients with ADAPT system. The complete recanalization rate was~     84% with ADAPT versus 68% with stent retriever (P = 0.006). Unpublished data, Oral~     presentation at the European Stroke Organization, April 2015). Our research aims to show that~     a first line strategy of recanalization by thrombectomy using a distal suction system (ADAPT)~     is superior that the use of a stent retriever.~   "
79738|NCT02523235|"~     Currently, continuous adductor canal and popliteal-sciatic nerve blocks are used commonly for~     lower extremity post-operative pain control, specifically for total knee arthroplasty and~     foot/ankle surgery, respectively. A perineural catheter used to infuse local anesthetic for~     postoperative analgesia may be placed at various locations along the target nerves.~     Investigations of single-injection peripheral nerve blocks suggest that the onset of the~     block might be faster with one location over the other; but, the success rates are~     equivalent. However, remaining unknown is whether there is an optimal location to place a~     perineural catheter as part of a continuous peripheral nerve block.~   "
79739|NCT02523222|"~     This will be a quasi-experimental study comparing blood glucose values 30 minutes after~     feeding alone or feeding + 40% dextrose gel in newborns at risk for transient neonatal~     hypoglycemia.~   "
79740|NCT02523209|"~     While the duration of renal transplant function has increased over the last decade kidney~     transplanted patients (KTP) still exhibit a fracture risk 4 times higher than in the general~     population. Fracture risk remains increased despite the improvement of immunosuppressive~     therapies (IST) that allowed the reduction of steroid administration. Potential explanations~     for this could be 1) that Chronic Kidney Disease (CKD) induces renal osteodystrophy that~     occurs before kidney transplanted, impairs bone metabolism and promotes bone fragility ; 2)~     that kidney transplanted patients are older and older (14% of kidney transplanted patients~     were older than 70 in 2011 in France), ageing being a major risk factor for fractures 3) IST,~     besides steroid, may have deleterious effects on bone and 4) that secondary~     hyperparathyroidism, a risk factor of fractures, persists after kidney transplanted . Thus,~     the pathophysiology and epidemiology of bone fragility of kidney transplanted patient remains~     insufficiently characterized. Despite these data, and contrarily to what is done for patients~     candidates for cardiac transplantation, there is no general consensus for performing bone~     evaluation before kidney transplanted . Thus it's necessary to individualize the management~     of bone fragility and prevent fractures according to strategies that remain to be defined,~     provided that patients at risk are better detected.~   "
79741|NCT02523196|"~     This study plans to learn more about a new test to look at liver function, the HepQuant-Shunt~     (HQ-Shunt). The HQ-Shunt is being evaluated for safety and effectiveness as an alternative to~     Hepatic Venous Pressure Gradient testing in patients with liver disease.~   "
79742|NCT02523183|"~     Many families of children with medically refractory epilepsy are choosing to use medicinal~     cannabinoids (MCBD) as an adjunctive alternative treatment option. The safety, tolerability~     and efficacy of these products are not known. The primary objective of this study is to~     determine how the use of MCBD affects children with medically refractory epilepsy in an~     observational study. Measures of evaluation to be used will include: laboratory values,~     developmental measures, seizure diaries and serial electroencephalographic (EEG) recordings.~   "
79743|NCT02523170|"~     A multicentre phase II study to determine the safety and efficacy of EUS-guided nCLE in~     patients with suspected cystic tumours of the pancreas in whom endoscopic ultrasound-guided~     fine needle aspiration (EUS-FNA) is clinically indicated. Patients will be recruited~     sequentially to undergo nCLE as part of their routine diagnostic evaluation, followed by~     standard surveillance. This part of the study will recruit 60 patients.~   "
79744|NCT02523157|"~     The Wellbeing in Pregnancy (WiP) project is an online pilot randomized controlled trial which~     aims to evaluate an intervention to improve women's emotional wellbeing in pregnancy.~   "
79745|NCT02523144|"~     Sedation Techniques for children undergoing transthoracic echocardiography (TTE).~   "
79746|NCT02523131|"~     The main study objective is to determine whether day and night automated closed loop glucose~     control combined with pump suspend feature will improve glucose control and reduce the burden~     of hypoglycaemia compared to sensor augmented insulin pump therapy alone.~      This is an open-label, multi-centre, multi-national, single-period, randomised, parallel~     group design study, involving a three-month period of home study during which day and night~     glucose levels will be controlled either by a closed loop system combined with pump suspend~     feature (intervention group) or by sensor augmented insulin pump therapy (control group).~      It is expected that up to 100 subjects, aiming for 84 randomised subjects [42 youth (6 to 21~     years), and 42 adults (22 years and older)], with type 1 diabetes will be recruited through~     paediatric and adult outpatient diabetes clinics in each of the investigation centres.~     Subjects who drop out within the first four weeks of the intervention may be replaced.~     Participants will all be on subcutaneous insulin pump therapy and will have proven~     competencies both in the use of the study insulin pump and the study CGM device.~      Subjects in the intervention group will receive appropriate training in the safe use of~     closed loop insulin delivery system and pump suspend feature. All subjects will have regular~     contact with the study team during the home study phase including 24/7 telephone support. The~     primary outcome is between group differences in the time spent in the target glucose range~     from 3.9 to 10.0 mmol/l (70 to 180mg/dl) based on CGM glucose levels during the 12 week free~     living phase. Secondary outcomes are HbA1 at the end of treatment period, the time spent with~     glucose levels above and below target, as recorded by CGM, and other CGM-based metrics.~     Safety evaluation comprises assessment of the frequency of severe hypoglycaemic episodes.~   "
79747|NCT02523118|"~     The purpose of this observational study is to find the best measures to define how well a~     person with eosinophilic disorder is doing. People with eosinophilic esophagitis (EoE),~     eosinophilic gastritis (EG), and eosinophilic colitis (EC) normally undergo endoscopy and/or~     colonoscopy (scope down the throat or up the bottom) where tissue specimens are collected for~     microscopic analysis. Treatments are then decided based on how the tissue looks. We are~     aiming to compare different tissue components such as inflammatory cell types with clinical~     symptoms. We want to see if scores on standard questionnaires can give us an idea how well~     the person is doing.~   "
79748|NCT02523105|"~     This study evaluates the use of brain activity monitoring for early identification of~     pharmaceutical treatment efficacy and development of depression deterioration events.~   "
79749|NCT02523092|"~     The objective is this study is to test whether use of Acthar gel in the context of~     sarcoidosis will lead to improved symptoms and lung function and correlate with decreased~     levels of predictive blood biomarkers, like chemokine ligand 9 (CXCL9).~   "
79750|NCT02523079|"~     The aim of the study is to compare the implementation and effectiveness of group and~     self-help based cognitive behavioral treatment for insomnia (CBT-I) delivered by occupational~     health services (OHS) in a randomized and controlled design (RCT) among different types of~     shift workers.~   "
79751|NCT02523066|"~     Clinical Study to Evaluate the Performance of Magna Ease Heart Valve in Chinese patients.~   "
79752|NCT02523053|"~     The aim of this study is to confirmed the role of intraoperative controlled release~     5-Fluorouracil therapy in the prevention of recurrence after surgery for HCC patients with~     high risk of preoperative prediction of microvascular invasion.~   "
79755|NCT02523014|"~     This phase II trial studies how well vismodegib and focal adhesion kinase (FAK) inhibitor~     GSK2256098 work in treating patients with meningioma that is growing, spreading, or getting~     worse. Vismodegib and FAK inhibitor GSK2256098 may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth.~   "
79756|NCT02523001|"~     The purpose of this study is to test the hypothesis that the function and/or regulation of~     urinary aquaporin 2 in hypercholesterolemic humans is affected by standard statin therapy, as~     compared with diet alone~   "
79757|NCT02522988|"~     The purpose of this randomized-controlled, crossover pilot trial is to evaluate the~     feasibility, acceptability and effects of a non-deceptive (open-label) administration of~     placebo pills for treating cancer related fatigue (CRF). If significant effects are found,~     the investigators will later determine if the presence of a COMT Val18Met genotype variant~     predicts placebo responses.~   "
79758|NCT02522975|"~     This study is aimed to comprehensively establish the biosimilarity/bioquivalence in EPIAO®~     and EPREX® in terms of 52-week comparisons in efficacy,safety and immunogenicity.The targeted~     population is anaemia patients with chronic renal disease who are naive to epoetin treatment~     and not yet on haemodialysis.~   "
79759|NCT02522962|"~     This project comprises a two-arm randomized controlled trial (RCT) complemented by~     qualitative research on innovative group-based intervention for people with Multiple~     Sclerosis (MS) performed in the primary health care and organized in collaboration with the~     services provided by a hospital's outpatient clinic. The RCT will be conducted by Nordland~     Hospital Trust, Bodø (NLSH), in collaboration with UiT The Arctic University of Norway (UiT)~     and the Norwegian Centre for Integrated Care and Telemedicine, University Hospital North~     Norway (NST). The overall purpose of the RCT is to demonstrate whether high-intensity~     individualised group-based core stability training (GroupCoreSIT) performed by~     physiotherapists (PTs) in the primary health care has effect on balance, walking and~     activities of daily living (ADL) in people with MS compared to standard care. Changes in~     quality of life and costs will also be studied to conclude whether the intervention is~     cost-effective. The qualitative study contains three parts. The first part aims to~     investigate users' experiences from participating in the new group intervention and in~     standard care. The researchers will particularly focus on reflections regarding content,~     feasibility, potential changes in ADL, self-management, and continuity of care. The second~     part will investigate how the PTs act and interact with the group while conducting the~     intervention, particularly how individualization is carried out, and the PTs' reflections~     from participating in the education and performance of the intervention. The third part~     explores health professionals' reflections regarding coordination of care in people with MS.~   "
79760|NCT02522949|"~     This study evaluates the performance of ColdZyme® mouth spray on prevention and alleviation~     of induced rhinovirus upper respiratory tract infection in healthy volunteers. Half of~     participants will receive ColdZyme® mouth spray while the other half will receive placebo.~   "
79761|NCT02522936|"~     This is a randomized placebo controlled trial of the use of Biotene versus no treatment in~     women receiving oral oxybutynin for overactive bladder. The primary outcome will be rate of~     discontinuation of oxybutynin at 6 month.~   "
79762|NCT02522923|"~     This study is a randomized controlled trial conducted at two clinical sites. The purpose of~     this study is to determine whether patients with musculoskeletal injuries do better by seeing~     a primary care provider first versus seeing a physical therapist first. Target enrollment is~     150 subjects.~   "
79763|NCT02522910|"~     This study part will be conducted in an open-label, non-randomized, Phase I conventional 3+3~     dose-escalating design to define the safety, tolerability, pharmacokinetics, and MTD of BAY~     1000394 (Roniciclib) given in a 3 days on / 4 days off schedule in combination with docetaxel~     in subjects with second- or third-line NSCLC.~   "
79764|NCT02522897|"~     The purpose of this study is to determine if additional panretinal photocoagulation of~     ischemic areas following retinal vein occlusion (RVO) may reduce the rate of recurrence and~     allow longer treatment intervals in anti-Vascular Endothelial Growth Factor (VEGF) treatment~     following the trea-and-extend scheme.~   "
79765|NCT02522884|"~     This is a prospective, multi-center, single-arm, non-blinded study designed to investigate~     the safety and efficacy of the Tack Endovascular System in subjects with post-balloon~     angioplasty (post-PTA) dissection(s) type(s) A through F in the superficial femoral and~     proximal popliteal arteries ranging in diameter from 2.5mm to 6.0mm.~   "
79766|NCT02522871|"~     A prospective, phased-pivotal, international randomized trial to evaluate the effectiveness~     of the OCS™ Liver to preserve and assess donor livers intended for transplantation.~   "
79767|NCT02522858|"~     Dexmedetomidine is a selective α2 adrenergic receptor antagonist, which has little effect on~     respiratory suppression used as sedative agent. Also, dexmedetomidine has been reported to~     prolong the anesthesia time when used with patients undergoing spinal anesthesia. However,~     dexmedetomidine has sympathetic effect which can cause hypotension and bradycardia dose~     dependently. Therefore, this study is aimed to evaluate the effectiveness of premedication of~     anticholinergic agents on vital sign in patients undergoing spinal anesthesia.~   "
79768|NCT02522845|"~     This study will be looking at the effect of compression therapy in patients having endovenous~     treatment for truncal incompetence of their varicose veins using either radiofrequency~     ablation (RFA) or endovenous laser therapy (EVLT). Patients will be randomised to either the~     compression group (group A) or the no compression group (group B).~      The pain scores, compliance, quality of life scores, occlusion rate at 6 months as well as~     the cost effectiveness of each intervention will be assessed.~   "
79769|NCT02522832|"~     A GMP rhinovirus was manufactured according to GMP and then characterised in human volunteers~     in the human viral challenge model.~   "
79789|NCT02522572|"~     The primary objective of this study is to conduct a proof of concept pilot study that will~     provide a preliminary evaluation of the safety of plerixafor alone or in combination with~     bortezomib on plasma cell mobilization, Human Leukocyte Antigen (HLA) antibody levels and~     toxicity profile in sensitized patients awaiting kidney transplantation.~      The secondary objective of this study is to conduct additional analyses of the study regimen~     on HLA antibody levels using multiple different assays and statistical analysis.~   "
79770|NCT02522819|"~     This project is focused on the treatment of obstructive sleep apnea in the acute phase of~     stroke. Stroke is a frequent pathology with a high morbidity and mortality rate. Although it~     has now been proved that obstructive sleep apnea syndrome (OSAS) is a risk factor of stroke,~     on the other hand, there is evidence that 50 to 70% of patients in the acute phase of stroke~     have obstructive sleep apnea (OSA) based on an apnea-hypopnea index (AHI) of ≥ 10. OSA is~     associated with worse functional outcomes and higher mortality in the post-stroke period.~     Profound hemodynamic fluctuations and hypoxia generated by sleep apnea are likely to~     aggravate cerebral ischemia, particularly in the acute phase of stroke in the potentially~     reversible ischemic penumbra. Continuous Positive Airway Pressure (CPAP) is the primary~     treatment for obstructive sleep apnea.~      Yet, to our knowledge, there have been very few studies aimed at demonstrating the value of~     CPAP in the treatment of obstructive sleep apnea in the acute phase of stroke. Only one~     randomised trial has provided the means to document neurological improvement at mid term (1~     month) in a targeted population.~      Before undertaking a comparative study evaluating the efficacy of CPAP in the acute phase of~     ischemic stroke, it is worth evaluating the feasibility and tolerance of introducing CPAP at~     the very early stage of ischemic stroke. Therefore, the purpose of our study is to evaluate~     the feasibility of CPAP in the treatment of OSA in the acute phase of ischemic stroke.~   "
79771|NCT02522806|"~     In spite of all progress realized in the field of assisted reproduction the pregnancy rate by~     In vitro fertilization (IVF) in France, across indications, is only 23% after IVF cycle.~      Different causes may account for these failures and that, during all stages of pregnancy.~      Recent studies have investigated an essential step in fecundation : uterine receptivity. Some~     teams have shown that a lot of immunological factors would have very significant in this~     step, by them possible expression in this process. Other studies looked at genes modulation,~     essential to implantation, with endometrium manipulation, simple, such as endometrial biopsy~     (EB). The last findings published on this subject, but after 2 IVF failures, are most~     encouraging because the pregnancy rate for these teams after just endometrial local injury~     (EB after 2 IVF failures) is well above their usual pregnancy rate. Some teams have focused~     on immunoassay of endometrial biopsy, in order to profile uterine receptivity and suggest~     with results, suitable treatment for each patient (ongoing study).~      EB is quick, easy, make in a simple consultation and with a low cost, contrary to~     immunological study, which depend of ultra-specialized laboratories and therefore with an~     important cost.~   "
79772|NCT02522793|"~     1. Purpose and objective: Determine spectroscopic differences between tumor, dysplasia, and~          normal cutaneous tissue as assessed by histopathologic diagnosis. If successful, the~          optical measurements could be used to survey for and delineate the extent of~          malignancies in a noninvasive manner.~        2. Study activities and population group: Competent adults with a clinically suspicious~          skin lesion who are undergoing a biopsy as part of their routine care. For those who~          agree to participate, the sterilized portable optical spectroscopic probe will be used~          to measure diffuse reflectance on the lesion of clinical interest.~        3. Data analysis and risk/safety issues: The optical spectrometer does not breach any skin~          defense barrier. As this study involves noninvasive optical measurements of tissues, no~          significant safety concerns are anticipated. Qualitative analysis will be performed to~          describe whether there is correlation between spectroscopy measurements and pathologic~          diagnosis. A variety of correlative statistics will be explored to determine if there~          are relationships found that can justify a larger study~   "
79773|NCT02522780|"~     The purpose of this trial is to investigate the safety and efficacy of mesalamine 2 g~     extended release granules (sachet) once a day (QD) for maintenance of clinical and endoscopic~     remission in subjects with UC. The duration of treatment for each subject will be 6 months.~   "
79774|NCT02522767|"~     The purpose of this trial is to investigate the safety and efficacy of mesalamine for the~     induction of clinical and endoscopic remission in subjects with active, mild to moderate UC.~     Subject will receive 4 g extended release granules (sachet) once daily.~   "
79775|NCT02522754|"~     A study to compare multiple dosage regimes of a protesomal intranasal vaccine.~   "
79776|NCT02522741|"~     The purpose of this study is to evaluate the efficacy of an evidence-based post-traumatic~     stress disorder (PTSD) intervention adapted to focus on parenting-related impairment for~     mothers receiving preventive services. The study intervention is adapted from Skills Training~     in Affective and Interpersonal Regulation (STAIR). The investigators expect that the adaption~     (Parenting STAIR) has the potential to prevent child maltreatment as well as improve maternal~     and child well-being by reducing the effects of maternal PTSD and depression on parenting.~      The investigators plan to recruit mothers with high levels of trauma-related symptoms from~     preventive service agencies, and invite them to participate in the study. This study is a~     single group design, and data will be collected pre-treatment, post-treatment, and 12-week~     follow-up.~   "
79777|NCT02522728|"~     The objective is to investigate the Clinical, Radiographic, Roentgen Stereophotogrammetric~     behaviour and patient outcome when using the Triathlon total knee prosthesis in a prospective~     randomized clinical trial.~   "
79778|NCT02522715|"~     This phase I/II trial studies the side effects and best dose of cabazitaxel when given~     together with enzalutamide in treating patients with prostate cancer that has spread to other~     places in the body (metastatic) and has not responded to treatment with hormones or no longer~     responds to treatment with hormones (hormone-resistant). Drugs used in chemotherapy, such as~     cabazitaxel, work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Androgen can cause~     the growth of prostate cancer cells. Hormone therapy using enzalutamide may fight prostate~     cancer by blocking the use of androgen by the tumor cells. Giving cabazitaxel together with~     enzalutamide may work better in treating metastatic, hormone-resistant prostate cancer.~   "
79824|NCT02522117|"~     Renal insufficiency is a priority disease in the health system, which may require renal~     replacement therapy based on kidney transplantation, which is considered as therapy of~     choice. During the procedure of kidney transplantation, the body is subjected to~     ischemia-reperfusion damage that generates late complications related to graft function.~      Recently the anti-inflammatory and immunomodulatory effects of statins have been emphasized,~     which could be beneficial in kidney transplantation.~   "
79779|NCT02522702|"~     The aim of the study is to develop a computer program which is able to distinguish between~     adenomatous and non- adenomatous polyps on the basis of optical features of the polyps. Still~     images of polyps (< 10 mm of size) will be collected during routine colonoscopy procedures.~     All polyps will be resected endoscopically so that histopathological diagnoses (gold~     standard) can be notified.~      In the validation phase of the study a computer program will be established which aims to~     distinguish between adenomatous and non- adenomatous polyps on the basis of optical features~     derived from still images. The program will operated using the the random forest learning~     method. Afterwards, in the testing phase of the study, still images of 100 polyps (not used~     in the validation phase) will be presented to the computer program. The establishment of a~     well- functioning computer program is the primary aim of the study.~   "
79780|NCT02522689|"~     It is aimed to evaluate the treatment results, rates of success and complications, and injury~     given to the kidney by measuring preoperative and postoperative blood and Cystatin C levels~     in patients with kidney stones smaller than 2 cm who will undergo either ultra-mini~     percutaneous nephrolithotripsy (PCNL) or micro PCNL.~   "
79781|NCT02522676|"~     It is aimed to evaluate the treatment results, rates of success and complications, and injury~     given to the kidney by measuring preoperative and postoperative blood urea, creatinine,~     Cystatin C and Netrin-1 levels and urine Cystatin C and Netrin-1 levels in patients with~     lower pole or renal pelvis stone(s) undergoing either one of the treatment modalities~     including conventional percutaneous nephrolithotripsy (PCNL), mini PCNL, ultra-mini PCNL,~     micro PCNL, retrograde intrarenal surgery (RIRS) and extracorporeal shock wave lithotripsy~     (ESWL).~   "
79782|NCT02522663|"~     Aortic Valve Replacement (AVR) surgery for aortic valve disease continues to increase in~     numbers. With better surgical techniques and equipment, also older patients can be operated~     on, resulting in an growth of the older population. AVR is characterized by high rates of~     hospital readmissions, resulting in suboptimal care planning and higher health care costs.~     Hence, it is important to develop strategies to reduce hospital readmissions following AVR.~     The purpose if this study is to develop and test the efficacy of a 24/7-phone support in the~     reduction of readmissions after AVR treatment. Secondary outcomes are a reduced level of~     anxiety, less depressive symptoms and a better health related quality of life.~   "
79783|NCT02522650|"~     This cross-over study is designed to test the hypothesis that amiloride will reduce urinary~     protein excretion and protect the kidney from rapid progression in proteinuric kidney~     disease.~   "
79784|NCT02522637|"~     International guidelines for pulmonary rehabilitation describe pathways dedicated to moderate~     COPD patients looking at the work setting, programs and frequency of training sessions in an~     outpatient program of rehabilitation. However, a new population of respiratory patients is~     growing: these are more serious and older patients, with several comorbidities and recurrent~     hospitalizations. In this population no guidelines are available to describe the optimum~     prescription in terms of frequency, intensity, type and timing (FITT) of rehabilitation. In~     this kind of patients, only few studies are available on the overtraining risk. The aims of~     the current study are:~        1. To detect and compare the response in terms of endurance of two endurance training~          programs with different time-frequencies (1 session / day versus 2 sessions / day)~          during 30 days of in-hospital admission to a pulmonary rehabilitation center~        2. To compare the effectiveness in terms of effort tolerance, dyspnea, peripheral and~          respiratory muscle strength, quality of life and psychological and functional impact of~          the disease.~   "
79785|NCT02522624|"~     The overall purpose of the study is to better understand how the investigators previously~     developed decision support (DS) tool can help people make decisions about health insurance~     plans available through the federal exchanges created by the Affordable Care Act (ACA). The~     investigators will evaluate the DS tool compared to the federal government website. The~     investigators will also evaluate the feasibility of disseminating this tool. There are two~     primary aims to be completed in this project: (1) examine the reach and effectiveness of the~     health insurance DS tool; and (2) collect stakeholders' feedback to improve the likelihood of~     implementation of the DS tool.~   "
79786|NCT02522611|"~     Background:~      Cancer-induced bone pain (CIBP) is common in people with cancer. Bone cancer can also lead to~     anxiety, depression, and reduced mobility and quality of life. Researchers believe a research~     drug called resiniferatoxin (RTX) may be able to help.~      Objective:~      To learn whether RTX is safe and can reduce cancer induced bone pain.~      Eligibility:~      People ages 18 and older with CIBP that is not relieved by standard treatments~      Design:~      Participants will have up to 6 outpatient visits over about 7 months. These will include:~      Medical history~      Physical exam~      Blood and urine tests.~      Thermal testing: a disk placed on the skin to test ability to sense temperature in and around~     the area of pain~      Chest x-ray~      EKG: stickers are placed on the chest to measure heart signals~      ECG: measures electrical activity of the heart~      Participants will have 1 inpatient visit lasting 2-4 days. This will include:~      Catheter inserted into a vein in the arm. They are given anesthesia, sedation, and x-ray~     contrast.~      A needle is passed through the skin of the back to inject the RTX.~      Participants will keep a log of the pain medications they take after surgery.~      Participants will be called 1 week and 2, 3, and 4 months after the injection.~      Participants will be mailed surveys and questionnaires to complete 2, 3, and 4 months after~     the injection.~   "
79787|NCT02522598|"~     VVZ-149 is a novel analgesic drug candidate that shows a potential analgesic activity~     inhibiting GlyT2 and 5HT2A simultaneously. These target receptors have been known to play~     important roles in induction and transmission of pain signals. There have been many efforts~     to develop selective drugs to treat pain, but usually unsuccessful due to the lack of~     efficacy or limitations of single-target approach for new drug discovery. VVZ-149 is expected~     to be a dual-target drug, demonstrated having a potential synergism between GlyT2 and 5HT2A~     to maximize an antinociceptive effect in the in vivo animal models. In Phase 1 conducted~     among healthy subjects, safety and tolerability were confirmed. Phase 2 was designed as a~     randomized, double-blind, parallel-group, placebo-controlled trial to evaluate the efficacy~     and safety of the analgesic drug VVZ-149 injection.~   "
79788|NCT02522585|"~     The objective of this study is to evaluate the outcome of cervical intraepithelial neoplasia~     grade 2 (CIN-II) patients followed up without treatment for 24 months according to p16 and~     ki-67 immunohistochemical staining and to the expression of NK cell receptors.~   "
79790|NCT02522559|"~     Herbs and spices offer one potential solution to the recent decline in children taking school~     lunch because they can increase the palatability of foods without adding salt and fat.~     However, there is currently limited evidence on how to successfully integrate herbs and~     spices into the school lunch menu. Developing evidence-based methods to teach school~     cafeteria workers to prepare healthy and tasty vegetable dishes with the addition of herbs~     and spices is a research priority. The investigators hypothesize that herbs and spices can be~     used to increase acceptance, intake, and participation in the school lunch program among 6th~     - 12th grade students from Central Pennsylvania.~   "
79791|NCT02522546|"~     Pneumococci are bacteria which can cause serious and potentially life threatening illnesses~     like meningitis and blood poisoning.~      Pneumococcal vaccines (PCV) have been given in the national immunisation schedule since~     2006.Carriage studies allow assessment of how the strains in the nose change over time, in~     that by clearing some strains away which other strains take up those niches in their place~     both in children and in their close/household contacts. This helps to inform the best use of~     the vaccines available and for future vaccine development and which strains would be useful~     to include.~   "
79792|NCT02522533|"~     Frailty has been associated with poor acute and long-term outcomes after major surgery. We~     recently determined that nearly 70% of patients undergoing major thoracic surgery are~     pre-frail or frail. We are interested in assessing whether a strength training intervention~     for frail or pre-frail patients has an impact on surgical decision making and on surgical~     outcomes.~   "
79793|NCT02522520|"~     Colorectal cancer is one of the most common cancers in Denmark, annually 4,200 men and women~     are diagnosed and approx. 2000 patients die of their colorectal cancer. As with other~     cancers, the risk of colorectal cancer increases with age, and the median age at diagnosis is~     71 years. Improved treatment has increased the number of survivors with an expected 5-year~     survival rate of 50-60%. Characteristic of this group of patients is that at the time of~     diagnosis they often live with comorbidities and have limited leisure time physical activity.~      There is evidence that rehabilitation in the form of physical exercise for cancer patients~     after their initial treatment has a positive effect on a number of physical and psychological~     parameter such as health-related quality of life, physical capacity and physical function,~     fatigue, anxiety and depression. However, the most frequently studied diagnosis group is~     women with breast cancer. Until now only few studies have evaluated the effects of physical~     activity among colorectal cancer patients receiving chemotherapy~      The purpose of this study is: to examine the effect of two different training initiatives -~     12 weeks progressive, high-intensity training versus low intensity exercise intervention - on~     physical, emotional and social habitus, in sedentary patients with colorectal cancer during~     adjuvant chemotherapy.~      The hypothesis of the study are: 1. That both interventions will show a positive association~     between increased physical capacity (measured by aerobic capacity VO2-peak / peak oxygen~     uptake) and improved physical function, reduced fatigue and anxiety in the included sedentary~     colorectal cancer patients undergoing adjuvant chemotherapy.~      Participants: Patients undergoing adjuvant chemotherapy for colorectal cancer who have~     self-reported physical activity level below the national recommended levels (less than 150~     min/week of moderate leisure time physical activity, and exercises at least 20 minutes of~     strenuous physical activity twice a week).~      Benefits and risks of participating: Possible benefits of the interventions: to reduce~     treatment related symptoms and side-effects, increase vitality and well-being and promote~     lifestyle changes among sedentary colorectal cancer patients receiving adjuvant chemotherapy.~     At participation in the interventions minor sports injuries may occur.~   "
79794|NCT02522507|"~     Despite the strong business case of hiring people with disabilities, a significant proportion~     of youth with disabilities leave high school and neither work nor continue their education~     and are unprepared to meet the demands of a work environment. Although youth with~     disabilities have much to gain from employment readiness programs, they are often excluded~     from, or have limited access to school and community vocational programs. One encouraging~     approach to address gaps in vocational programming is through peer mentoring, which may~     facilitate a smoother transition to adulthood by offering support to enhance coping skills.~     Despite the increase in online communities, little is known about their impact on vocational~     mentoring for youth with physical disabilities and their parents. The purpose of this study~     is to develop, implement and assess the feasibility of an online peer mentor employment~     readiness intervention for youth with physical disabilities and their parents to improve~     their self-efficacy, career maturity and social support.~   "
79795|NCT02522494|"~     Diabetes is common, it is expensive, and it is a chronic condition. Estimates put the~     prevalence of diabetes at almost 20 percent in VA patients. Poorly controlled diabetes leads~     to a number of complications including cardiovascular disease, blindness, amputation, and end~     stage renal disease. Adherence to medication regimens (as well as lifestyle factors such as~     diet and exercise) is important to achieve diabetes care goals. Adherence to recommended care~     is related at least in part to effective communication in medical encounters. This project is~     designed to test a video intervention to improve patients' communication behaviors. Providers~     will also receive a pamphlet with specific recommendation to improve communication skills.~     The project will assess the impact of the training programs on communication and outcomes.~     The study is designed to help make patient care more patient-centered, which is one of the~     six aims for improvement in the IOM Report, Crossing the Quality Chasm and is a goal of VA~     transformation efforts.~   "
79796|NCT02522481|"~     The purpose of this study is to assess the safety and efficacy of Lumason-enhanced dobutamine~     stress echo (DSE) in subjects having a suboptimal left ventricular endocardial border~     delineation (LV EBD) at rest and who are scheduled for coronary angiography.~   "
79797|NCT02522468|"~     The purpose of this randomized trial is to determine the superiority of utilizing radioactive~     seed localization (RSL) over wire-guided localization (WL) for palpable or non-palpable~     malignant lesions in patients undergoing breast conservation surgery (BCS).~   "
79798|NCT02522455|"~     This short pilot study is to assess the tolerance of preterm infants, born below 32 weeks~     gestation with respiratory distress syndrome, to flow-cycle ventilation, and see if infants~     require less overall pressure from the ventilator than the usual conventional settings used,~     with the aim of providing data to construct a larger trial looking at the longer term outcome~     of these infants using this type of ventilation in the future.~      Many preterm infants at these gestations require assistance from a ventilator due to the~     immaturity of their lungs. The lungs of preterm infants are susceptible to damage, especially~     if high pressures are needed or prolonged periods of ventilation. There is concern that if~     the infant's breathing pattern does not synchronise with the ventilator, this causes~     additional distress, longer duration of ventilation needed and increased risk of~     complications. Over the past 20 years, a different type of ventilation, known as flow-cycle~     ventilation, has been trialed, with limited use in preterm infants. This allows the baby to~     determine the duration of breathing in and out and how many breaths they require per minute.~     This would help babies to synchronise better with the ventilator, and consequently require~     less pressure from the ventilator.~      This pilot study is being conducted at St. Mary's Hospital, Manchester. All babies born under~     32 weeks gestation, with a stable respiratory effort, will be eligible for consideration for~     the study. The study will last no longer than 5 hours and involve the babies receiving~     different pressures from the ventilator in flow-cycle mode for 1-hour epochs. Blood gases~     after each epoch and continuous ventilator data will be downloaded to assess their tolerance~     on the different settings, before being returned to the usual conventional settings used on~     the unit. The babies will have continuous monitoring throughout as per standard neonatal~     intensive care.~   "
79834|NCT02521987|"~     The purpose of this study is to determine if there is a difference in pain perception by~     participants when the assistant port size varies by 50% (8 mm to 12 mm).~   "
79799|NCT02522442|"~     The primary objective outcome is the proportion of participants compliant (at least four~     hours of use per night for all nights) in the Auto Bilevel group compared to the continuous~     positive airway pressure (CPAP) group after 90 days of treatment during the investigation.~     Proportion will be calculated using the cumulative number of hours on therapy divided by the~     total number of days of the investigation for each participant. The mean and standard~     deviation of these mean therapy hours will then be calculated for each arm of the~     investigation. Participants with compliance of at least four hours will be classified as~     compliant and those with less than four hours will be classified as non-compliant. The~     null hypothesis will be rejected if the mean of the primary objective outcome for all~     participants in the BiPAP® Auto with Bi-Flex® therapy (auto Bilevel) arm is significantly~     greater than that for all participants in the CPAP therapy arm~   "
79800|NCT02522429|"~     Few neurological conditions are as scientifically mysterious and clinically, legally, and~     ethically challenging as disorders of consciousness. To date there exists no standard~     intervention for patients suffering from these devastating conditions. The present project is~     aimed at evaluating the potential of non-invasive Low Intensity Focused Ultrasound Pulsation~     (LIFUP) of thalamus (a key area for the consciousness network) as a neurorestorative~     stimulation for those patients. In this study, LIFUP will be performed during two sessions.~     The proposed experiment will involve behavioral and paramedical measurements just before and~     after each of the two LIFUP sessions in a small sample of patients (up to 15) in order to~     evaluate the feasibility of a full scale clinical trial. Outcome measures will be~     administered at discharge, 6 months and one year after injury.~   "
79801|NCT02522416|"~     Corneal topography allows the measure of the radii of curvature and of the thickness of the~     cornea. It is essential for diagnosis in ophthalmology and allows to highlight corneal~     irregularities such as a keratoconus, or too thin corneas which are a contra-indication for~     laser refractive surgery.~      Several types of corneal topographers are commercially available. Some as the Orbscan(r),~     operate by analyzing the image of the patterns of a Placido disk associated with a light~     slit, allowing the collection of thousands of points of the anterior and posterior surface of~     the cornea. More recent systems such as the Pentacam(r) are based on automatic rotary cameras~     which capture images of the whole anterior segment of the eye. The aim of this study is to~     compare two topographs, the Pentacam(r) and the Orbscan(r) and, more specifically, the~     central corneal pachymetry measurements measured pre- and postoperatively.~   "
79802|NCT02522403|"~     The patients with distal radius fracture treated with immobilization (cast) and percutaneous~     pinning it will be to able to participate in this randomized trial. The investigators will be~     able to determine if the laser acupuncture is a good therapy for the rehabilitation in this~     type of patients. And if they are more comfortable to begin his rehabilitation exercise after~     the application of this therapy~   "
79803|NCT02522390|"~     The primary objective of the planned Nutrition Research Cohort (NRC) n250 study is to develop~     and evaluate the open access Nutrition Researcher Cohort for gathering personal health data~     from nutrition researchers, including analytical methods, standards and operation procedures,~     data infrastructure, ethical and privacy aspects, and governance.~      Besides, the study aims to exploit and analyse data on food, nutrient and bioactive compound~     intake and exposure, biomarkers for food, health and/or disease and health and/or disease~     related measurements to study the relation between nutrition, health and development of~     disease (on individual level).~      In addition, data will be used to develop applications that visualise personal health risks~     based for example on (validated) recommendations and applications that predict individual~     health risks.~      The study is designed as an open, one-group, exploratory cohort study. The total NRC cohort~     will be composed of about 250 life sciences employees and students from different,~     predominantly European, countries. This allows optimal involvement of participants in shaping~     all aspects of the cohort and the ownership of data. We aim to recruit about in total 20 male~     and female scientists per participating country.~   "
79804|NCT02522377|"~     In this proof of concept study, the investigators plan to administer iv ketamine interleaved~     with ECT days.~      Patients with treatment resistant depression who are deemed to be eligible for ECT treatment~     will randomly be assigned to either ketamine or active placebo.~   "
79805|NCT02522364|"~     Postoperative atrial fibrillation and atrial flutter (POAF) is the most common complication~     after cardiac surgery requiring intervention or prolonged hospital stay.~      POAF is associated with higher mortality and higher risk of thromboembolic events.~      However, It is yet unknown whether a now event of postoperative atrial fibrillation is an~     indication of a chronic arrhythmic disease - a tendency towards developing recurrent atrial~     fibrillation or merely a response to the stress of surgery with not recurrence. This~     distinction is critical to determine the appropriate therapy. Since recurred events of atrial~     fibrillation (Paroxysmal atrial fibrillation) are associated with long term risk for stroke~     and thromboembolic evens patients with PAF are treated with long term anticoagulation.~     Missing the long term recurrence of arrhythmia may result in under-treatment and pose a~     significant risk of stroke.~      Bio-Monitor is a subcutaneous implanted device that automatically detects arrhythmias and~     stores electrocardiogram (ECG) recordings. It will enable the detection of atrial~     fibrillation over a period of years and allow correct diagnosis and appropriate treatment.~      The purpose of the study is to study the long term behavior of POAF, determine the likelihood~     of developing paroxysmal atrial fibrillation in patients with POAF and to define the risk~     factors for this eventuality~   "
79806|NCT02522351|"~     The aim of the trial is to identify any systematic effect of cohesiveness on the efficacy of~     swallowing in patients having dysphagia problems.~   "
79807|NCT02522338|"~     Cystatin C, a protease inhibitor produced by most nucleated cells, is freely filtered by the~     kidneys, and its plasma assay reflects the GFR.~      Compare, in HIV patients, the predictive performance of 11 formula to estimate GFR based on~     assay plasma cystatin C with that of the MDRD formulas.~   "
79808|NCT02522325|"~     This study will determine the initial efficacy of phendimetrazine as a pharmacotherapy for~     cocaine dependence. A rigorous, inpatient human laboratory study will be conducted in which~     the subjective, physiological and reinforcing effects of cocaine are evaluated during~     maintenance on placebo and phendimetrazine.~   "
79809|NCT02522312|"~     A retrospective analysis of Restasis® benefits in dry eye contact lens patients.~   "
79810|NCT02522299|"~     The purpose of this study is to evaluate specific alterations in immune cell mechanisms~     related to neutrophil function as detected by PI3Kdelta-dependent changes in messenger~     ribonucleic acid (mRNA) extracted from induced sputum in patients experiencing an~     exacerbation of COPD, with or without treatment with GSK2269557. The efficacy of treatment~     with GSK2269557 will also be measured using functional respiratory imaging (FRI) and~     spirometry. This is a randomised, double-blind, placebo-controlled, parallel-group study. The~     study consisted of Screening Phase (up to 3 days prior to Day 1), Treatment Phase (Days 1 to~     84) and Follow phase (7 to 14 days after last dose). The total duration of the study is 13-14~     weeks including the screening visit.~   "
79811|NCT02522286|"~     This study implements a simple evidence-based patient activation intervention - Ask 3~     Questions- augmented by a novel theory-based intervention - Open Communication - aimed at~     activating patients and healthcare providers. The goal of this project is to increase patient~     and physician's preparedness for more having more questions, expressing differing opinions,~     and working collaboratively in making medical decisions that are both informed and responsive~     to patients' needs and preferences.~   "
79812|NCT02522273|"~     A cardiotocograph (CTG) can be used in labour to assess the heartbeat and well-being of a~     baby. An abnormal CTG may be a sign that a baby has low oxygen levels (hypoxia) and is~     becoming distressed.~      In this situation a blood test can be taken from the scalp of the baby. A high lactate level~     in the blood indicates that urgent delivery is required to prevent long-term harm to the~     newborn.~      SensPoint is a new medical device that measures lactate. It has several potential benefits~     over the current method of measuring lactate in that it is a portable hand-held device~     (allowing for use in the delivery room), requires a much smaller volume of blood and produces~     results more quickly than the current method of measuring lactate.~      Before a new device is adopted into clinical practice, it is important that it is first~     confirmed that it is accurate and reliable for its intended use. This study will evaluate the~     ability of the SensPoint device to accurately and reliably detect lactate in fetal and~     umbilical cord blood by comparing its performance to the reference device currently in use.~   "
79813|NCT02522260|"~     This study on women with breast cancer during and after chemo- and hormonal therapy compares~     the effect of different physical training programs on physical and mental well-being and~     systemic inflammation mechanisms in blood. In a sub-group of participants, mitochondrial~     biogenesis and function and other molecular processes in skeletal muscle biopsies are~     studied. The women will be randomly allocated into three different intervention arms, a~     control arm with usual care and two different training arms. All participants will respond to~     questionnaires and have blood samples and taken and for a subgroup muscle biopsies before and~     after the exercise intervention. Participants will be supported to uphold exercise through~     collaboration with Friskis & Svettis and followed for 5 years. Some of the women will also be~     asked to participate in an in depth interview about the experiences of exercise during~     ongoing treatment. This study will contribute to increased knowledge about the type,~     intensity and frequency of training that patients with breast cancer benefit most from with~     regards to impact on physical and mental wellbeing. This knowledge is of great importance~     since experience shows that patients and relatives often seek information about~     rehabilitation, self-care and physical activity. The study will also contribute to the~     improvement of the patients´ quality of life, ability to return to work, and reduce social~     costs, but above all, increase the possibility for development and implementation of~     evidence-based rehabilitation of women with breast cancer during and after active treatment.~   "
79814|NCT02522247|"~     To compare the effect of uvulopalatoplasty with no treatment in treating adult OSA.~   "
79815|NCT02522234|"~     This study was a phase Ib study of the safety and pharmacokinetics/pharmacodynamics of F-627~     once per cycle as prophylaxis therapy to chemotherapy in women with breast cancer.~      The patients received the intravenous administration of the chemotherapy (docetaxol,~     doxorubicin and cyclophosphamide, 75 mg/m2, 50 mg/m2 and 500 mg/m2 respectively) on Day 1 and~     the subcutaneous injection of F-627 at 240 µg/kg and 320 µg/kg on Day 2 (approximately 24~     hours after chemotherapy) each cycle for up to 6 cycles.~   "
79816|NCT02522221|"~     TACT is a real world randomized controlled trial of tecarfarin, a novel vitamin K~     antagonist, vs. warfarin. The quality of anticoagulation control will be compared for the two~     groups of subjects who require chronic oral anticoagulation for a broad panel of indications.~   "
79817|NCT02522208|"~     This study will investigate cardiovascular parameters using echocardiographic and~     pharmacokinetics during a daily dose of BiDil and BiDil Extended Release (XR) compared to a~     study drug free day.~   "
79818|NCT02522195|"~     This study assessed the meal distribution across the day (energy and macronutrient intake)~     and its relationship to the nutritional status of nursing professionals.~   "
79819|NCT02522182|"~     The purpose of the ALLEPRE trial is to compare the benefit offered by a structured, intensive~     and fully nurse-led intensive secondary prevention intervention programme with that offered~     by standard of care in a high-risk population of patients admitted to hospital because of an~     ACS.~   "
79820|NCT02522169|"~     This clinical trail intends to evaluate interventions based on the Infliximab trough levels~     for an individualized therapy adaption for pediatric IBD-patients undergoing~     anti-TNF-alpha-therapy. Main aim of the individualized strategy is to attain and maintain~     early disease control in order to keep as many patients as possible in disease remission, and~     to avoid primary and secondary therapy failure.~   "
79821|NCT02522156|"~     Almost one-fifth of US adults are current cigarette smokers. To make further progress in~     lowering prevalence, it would help to increase the proportion of smokers attempting to quit.~     This application tests a novel approach to motivating smokers to quit, based on an~     empirically supported theory of anxiety. The approach uses guided imagery to increase~     smokers' sense of urgency about preventing the negative health consequences of smoking.~   "
79822|NCT02522143|"~     Study Aims/Objectives:~      This projects' Primary Aim is development of a Condensed DBT Stepped Care Model tailored to~     the unique requirements of students meeting sub-clinical diagnostic criteria for BPD~     (Borderline Personality Disorder) with its associated high rate of self-harm and suicide.~   "
79823|NCT02522130|"~     Different ways of reducing pain during IUD insertion have been explored. So a randomized~     study will be conducted to test their role~   "
79825|NCT02522104|"~     The use of hydroxyurea in sickle cell disease patients with glomerular hyperfiltration and~     renal failure requires a specific monitoring and dose adjustment in order to remain within~     the therapeutic interval while limiting the risk of toxicity or therapeutic failure. For this~     reason the investigators propose to compare the pharmacokinetic parameters of hydroxyurea in~     normal-renal function sickle cell patients to those of patients with glomerular~     hyperfiltration or moderate renal failure.~   "
79826|NCT02522091|"~     Investigators propose in this study to evaluate prospective memory (MP) in all its complexity~     as well as the processes, cognitive and brain, the underlying. Specifically, investigators~     propose to evaluate the evolution of the MP during normal aging and Alzheimer's disease (AD)~     to identify the cognitive and brain processes underlying this development. To do this, this~     study will have to include healthy subjects, 18 to 95 years, patients with Mild Cognitive~     Impairment (MCI) and patients with probable AD. All participants will undergo a series of~     examinations, both neuropsychological and brain imaging.~   "
79827|NCT02522078|"~     This study aims to verify whether the moisture of 400 µg of misoprostol pre uterine~     evacuation increases the dilatation of uterine cervix compared to dry misoprostol~   "
79828|NCT02522065|"~     The motor impairment produced by Parkinson's disease (PD) is a significant and debilitating~     part of the condition. Current methods to evaluate this impairment rely on subjective~     examinations. The investigators seek to develop an objective assessment of motor deficits by~     monitoring the participants natural interactions with a keyboard (on a computer or smart~     device). This approach provides a window to how the brain behaves during typical daily use of~     these devices, i.e. writing a report, sending an email or any other task performed on a~     digital device and thus has the potential to be used easily and regularly. (Importantly, the~     data gathered are non-sensitive and based only on timing information).~      PD participants will be recruited during outpatient visits to PD clinics throughout the~     Madrid metropolitan region. General entry criteria will be those patients who are scheduled~     to begin dopaminergic therapy, and own a home computer or laptop. The study will not impact~     on participants' standard clinical management other than by asking the participants to type~     for 15 minutes at each of 3 clinic visits, and installing the investigators proprietary~     software on their home computer. This software will collect keystroke data alone. (None of~     the actual information about what is being typed will be collected.) The keystroke data~     collected will be analyzed and compared with standard clinical metrics of therapeutic~     response, as well as the in-clinic typing data.~   "
79829|NCT02522052|"~     Rheumatoid arthritis (RA) is a chronic disease that affects ~1% of the population. A large~     proportion of patients with established disease have persistent high disease activity in~     spite of existing effective pharmacological treatment. Improved treatment is thus urgently~     needed, including alternative treatments in addition to optimal pharmacological therapy. The~     main purpose of this study is to investigate if a high intake of blue mussel (Mytilus Edulis)~     could decrease inflammation and disease activity in patients with established RA. A secondary~     goal is to identify novel biomarkers for blue mussel intake and metabolic responses to this~     diet, using a metabolomics approach with high sensitivity and specificity. A third goal is to~     look at genetic polymorphisms in relation to long chain polyunsaturated fatty acids (LCPUFA)~     and inflammatory markers.~   "
79830|NCT02522039|"~     Investigation of the effect on the pupillary constriction by latanoprost, dorzolamide,timolol~     in healthy subjects. The pupillary constriction is compared to no drug.~   "
79831|NCT02522026|"~     Between 2012 and 2014, a cohort of 90 COPD subjects of disease severity grades GOLD I-IV as~     well as 60 healthy control subjects (30 smokers and 30 non-smokers) have been examined~     regarding different clinical and blood/ sputum derived biomarkers at the investigators'~     research center. This observation study will follow-up/re-examine all available subjects~     regarding disease course and treatment changes after 3 years (+/-6 months) for the~     investigation of ncRNA/ transcriptome biomarkers for their potential to indicate disease~     progression. In addition, biobanking of respective biosamples for potential future COPD~     biomarker research will be conducted.~   "
79832|NCT02522013|"~     Post-dural puncture headache (PDPH) is the most common complication of lumbar puncture. Its~     clinical manifestations are pain in the forehead and the occipital region, or diffuse~     headache. The pain is dull or fluctuating, becoming worse when standing and better when lying~     down, and is often accompanied by symptoms including a stiff neck, tinnitus, hearing loss,~     photophobia, and nausea, which cause great suffering to the patients1. According to~     epidemiological data, approximately 10% to 30% of the patients who undergo lumbar puncture~     suffer from PDPH within 48 hours of the procedure.Currently, commonly used treatments for~     PDPH include rehydration, the administration of corticotropin, caffeine, or sumatriptan, and~     the application of an epidural blood patch. The efficacy of theophylline has been proven in a~     placebo-controlled study in which 17 PDPH patients received an intravenous (IV) injection of~     200 mg theophylline. The Visual Analogic Scale scores 4 hours after treatment were~     significantly different compared with those of the placebo group5. At present, the clinical~     application of theophylline has been replaced by aminophylline and doxofylline, and it is~     difficult to purchase theophylline in most hospitals in China and other countries.~      The Aminophylline for Patients With Post-Dural Puncture Headache trial, is a~     prospective,randomized,double-blind,placebo-controlled trial to evaluate the efficacy and~     safety of an IV injection of aminophylline on post-dural puncture headache.Eligible patients~     were randomized in a blinded fashion(1:1) to receive IV injection of aminophyllineor or~     sterile isotonic saline.The investigators estimate that this trial will demonstrate that an~     IV injection of aminophylline could be the preferred method for the clinical treatment of~     PDPH.~   "
79833|NCT02522000|"~     Functional dyspepsia (FD) is a heterogeneous disorder with multifactorial pathophysiology.~     Patients with FD have visceral hypersensitivity to mechanical and chemical stimuli. Several~     previous studies have described an increased chemosensitivity to oral capsaicin ingestion.~     Capsaicin is a natural agonist of TRPV-1 receptors present on afferent sensory neurons.~     Activation of the TRPV-1 receptor by capsaicin or other agonists results in the release of~     several neuropeptides (i.e. substance P, somatostatin). Besides, increased duodenal~     permeability and disruption of tight junction structure in FD patients compared to healthy~     volunteers has been reported in a recent study. In this observational study investigators~     will evaluate the role of the TRPV-1 neuropeptide pathway in patients with functional~     dyspepsia and healthy controls.~   "
79835|NCT02521974|"~     Sabin 2 will be withdrawn from routine use globally from April 2016 as per the SAGE~     recommendations at the time of writing this protocol. After this cessation of OPV2,~     stockpiles of mOPV2 will be maintained for potential use if necessary in response to a future~     outbreak. However, there will be a risk of cVDPV2 from Sabin 2 in settings of low population~     immunity. Research is ongoing to develop vaccines that are genetically more stable than the~     currently available Sabin 2-containing OPVs. To generate data on immunogenicity, safety, and~     genetic stability on the Sabin 2 vaccine (mOPV2) and as a future comparator for new polio~     vaccine research after the global switch from tOPV to bOPV, this study with mOPV2 is~     performed to evaluate safety, immunogenicity (humoral and intestinal) and genetic stability~     endpoints of mOPV2 in children aged 1 to 5 years and in infants approximately 18 weeks of~     aged vaccinated with bOPV-/IPV for better understanding of the stockpile use of this vaccine,~     and for comparison with any potential new polio vaccine with a type 2 component in the~     future.~   "
79836|NCT02521961|"~     This randomized clinical trial studies a support group program in improving quality of life~     in underserved urban Latina breast cancer survivors. A psychosocial support group program may~     help reduce distress and improve health-related quality of life in underserved urban Latina~     breast cancer survivors.~   "
79837|NCT02521948|"~     The purpose of this study is to evaluate the safety and performance of the MANTA Vascular~     Closure Device (VCD) to close the arteriotomy following percutaneous cardiovascular~     procedures utilizing large bore sheaths for purposes of supporting a CE Mark (Conformite~     Europeenne--European Conformity) and other regulatory submissions. The study will assess~     whether the MANTA VCD is safe and performs as intended for large-bore vascular closure after~     interventional procedures.~   "
79838|NCT02521935|"~     Purpose: To compare complete denture outcomes between conventional and digital denture~     fabrication processes.~      Participants: Sixteen edentulous adult patients in the University of North Carolina School of~     Dentistry Student Clinic who are seeking removable complete dentures.~      Procedures (methods): Two complete sets of dentures will be fabricated for each subject: one~     using the conventional process (A) and the other using a digital process (B). Variability~     will be assessed by the research team, the treating dental students, an independent~     prosthodontist, and the patients through quantitative measures. Case selection and results~     analysis will be evaluated with recognition of the Prosthodontic Diagnostic Index.~   "
79839|NCT02521922|"~     To assess the feasibility and usability of the VSP System in the in-patient hospital setting~     to monitor vital signs using a patch, brain, gateway, and console. The VSP System will be~     incorporated into the study site's Information Technology infrastructure.~   "
79840|NCT02521909|"~     The purpose of this study is to compare the accuracy of different apex locators. Before root~     canal therapy, dentists use a device called an electronic apex locator (EAL) to measure the~     root canal and to locate its opening at the tip of the tooth's root (called the apical~     foramen). A root canal is the space inside the root of a tooth. If the tissue within the root~     canal becomes infected, dentists may perform root canal therapy.~   "
79841|NCT02521896|"~     The study is intended to assess the safety and performance of the Vado™ Steerable Sheath in~     facilitating ease of access to the pulmonary veins (PV) for the treatment of paroxysmal~     atrial fibrillation and persistent atrial fibrillation (AF). The study will be a prospective,~     single-center, non-randomized investigation.~   "
79842|NCT02521883|"~     The aim is to investigate the safety and effectiveness of transcranial Direct Current~     Stimulation (tDCS) in patients with moderate to severe major depression compared to patients~     treated with conventional therapy. The tDCS will be used as add-on to conventional therapy.~      This is a randomized 2-arm parallel, double blind study comparing 2 groups of 60 patients.~   "
79843|NCT02521870|"~     This is a phase 1b/2, open-label, multicenter trial designed to evaluate the safety,~     tolerability, biologic activity, and preliminary efficacy of intratumoral SD 101 injections~     in combination with intravenous pembrolizumab in patients with metastatic melanoma or~     recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).~      Phase 1 of this trial is a modified 3+3 dose escalation study evaluating escalating or~     intermediate dose levels of SD-101 given with a fixed dose of pembrolizumab in patients with~     metastatic melanoma.~      Phase 2 of this study will consist of 4 expansion cohorts to further evaluate the efficacy~     and safety of SD-101 given in combination with pembrolizumab in specific melanoma and HNSCC~     populations: For each of the indications in melanoma and HNSCC 2 separate cohorts will be~     recruited, those who are anti-programmed death receptor-1/ligand 1 (anti-PD-1/L1) therapy~     naïve and those who have progressive disease (PD) while receiving anti-PD-1/L1 therapy.~   "
79844|NCT02521857|"~     This study will evaluate the impact of water consumption on the pharmacokinetics of ALKS~     5461.~   "
79845|NCT02521844|"~     This is a Phase 1A/B study consisting of three parts. Part A is a non-randomised, open-label,~     sequential evaluation of the safety, pharmacokinetics, maximum tolerated dose (MTD), and~     recommended dose (RD) of ETC-1922159 in patients with advanced or metastatic, or unresectable~     solid malignancies, for whom no approved treatment option or standard of care is available.~     Dose escalation, with the goal of identifying the MTD and RD, will be guided by an ordinal~     continual reassessment method (oCRM) model with a cohort size of one patient.~      Part A extension is a non-randomised, non-comparative, open-label evaluation of the safety~     and tolerability of ETC-1922159 together with the bone protective treatment (denosumab) in~     patients with advanced or metastatic, or unresectable solid malignancies, for whom no~     approved treatment option or standard of care is available.~      Part B will be a non-randomised, non-comparative, open-label evaluation of the safety and~     tolerability of the RD of ETC 1922159 in patients with advanced or metastatic, or~     unresectable solid malignancies, for whom no approved treatment option or standard of care is~     available, with a molecular phenotype that is expected to make them sensitive to PORCN~     inhibitor treatment.~      It is anticipated that the study will take approximately 42 months to complete (approximately~     30 months for Part A and Part A extension, and approximately 12 months for Part B).~   "
79867|NCT02521545|"~     The primary objective of the study is to assess the pharmacokinetic (PK) profile of BIIB061~     in the new oral formulation in the fasted state in healthy male and female volunteers. The~     secondary objective of this study is to evaluate the safety and tolerability of BIIB061 in~     the new formulation in this study population.~   "
79846|NCT02521831|"~     Significant concern regarding the safety of general anesthesia in children has arisen due to~     myriad animal studies suggesting neurotoxicity of commonly used anesthetic agents.~     Inflammation of the central nervous system after anesthesia may have a significant role in~     the pathogenesis of anesthetic-induced neural injury. To evaluate this hypothesis, the~     investigators propose to randomize healthy infants undergoing elective surgery to one of two~     anesthetics: 1) spinal anesthesia only; or 2) general inhalational anesthesia with~     isoflurane, laryngeal mask airway (LMA) or endotracheal tube (ETT), and single-shot caudal~     block. Primary endpoint will be serum inflammatory biomarkers and transcriptome analysis and~     secondary endpoint will be neurocognitive outcome at 6 months and 1 year.~   "
79847|NCT02521818|"~     This trial seeks to establish the feasibility of implementing a ketogenic, modified Atkins~     diet (MAD) to older adults with mild cognitive impairment (MCI) or early Alzheimer's disease~     (AD) living in the community. A secondary aim is to determine whether adherence to the MAD~     results in better cognitive test scores than adherence to a non-ketogenic control diet. A~     final aim is to determine the role of apolipoprotein E (ApoE) genotype in participants'~     response to the MAD. Participants will be randomly assigned to a 12-week trial of either the~     MAD or a placebo diet based on the National Institute on Aging's recommendations for senior~     nutrition.~   "
79848|NCT02521805|"~     A randomized cross-over meal study will investigate the effects of protein quality and a~     combination of dietary fibre and protein on appetite regulation.~      The study will use basic measures of ad libitum energy intake and visual-analogue scales of~     appetite (study A). A sub-study (study B) will additionally include blood collection from 15~     of the 40 participants to investigate biological markers targeted satiety.~      The study days will be conducted at least one week apart to eliminate carry over effects. In~     the sub-study, the study days will be at least two weeks apart due to blood collection.~   "
79849|NCT02521792|"~     Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease~     characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) that result~     in abnormal bone formation (heterotopic ossification or HO) in muscles, tendons, and~     ligaments. Flare-ups begin early in life and may occur spontaneously or after soft tissue~     trauma, vaccinations, or influenza infections. Recurrent flare-ups progressively restrict~     movement by locking joints leading to cumulative loss of function and disability. Mouse~     models of FOP have demonstrated the ability of retinoic acid receptor gamma (RARγ) agonists~     such as palovarotene to prevent HO following injury. This 36-month study will evaluate the~     long-term safety and efficacy of episodic treatment with palovarotene for flare-ups in FOP~     subjects who successfully complete two flare-up treatment periods (6 weeks duration) and two~     follow-up periods (6 weeks duration) in Study PVO-1A-202.~   "
79850|NCT02521779|"~     The purpose of this study was to determine the effect of different dietary fats (saturated or~     unsaturated) on postprandial endotoxemia and systemic low grade acute inflammation. The~     investigators hypothesized that meals rich in saturated or n-6 fatty acids would increase~     postprandial endotoxemia but meals high in n-3 fatty acids would decrease postprandial~     endotoxemia.Participants were recruited via email and randomized to treatment meal in this~     single-blind, cross-over study. Each test session participants reported to the laboratory~     right away in the morning. An indwelling catheter was inserted into the participant~     non-dominant arm by a qualified nurse and a baseline blood draw was taken. The participant~     was then provided with one of four test meals (a porridge-type meal containing a different~     dietary fat), which they ate in entirety within 15 minutes. The participants remained in the~     laboratory for the next five and a half hours and were not allowed to consume any food or~     drink except water. During this time, further blood draws were taken at intervals of one hour~     for a total of five hours after the consumption of the test meal. Collected blood was~     processed on-site and the serum fraction collected and tested for endotoxin, inflammatory~     biomarkers, and metabolites.~   "
79851|NCT02521753|"~     Polycystic ovary syndrome (PCOS) is the most prevalent endocrine disorder in reproductive age~     women. PCOS is usually characterized by an excessive androgen production, menstrual~     irregularities, and polycystic ovaries. Women with PCOS are often obese and have a varying~     degree of insulin resistance (IR). Weight reduction constitutes the initial treatment for~     these patients. Metformin has proven to be useful in IR and is frequently used in PCOS.~     However metformin use may be accompanied by gastrointestinal discomfort, and a high abandon~     rate. Other therapeutic alternatives such as magnesium and polyunsaturated fatty acids have~     been used in other IR states and may be useful in PCOS. The aim of this study is to asses the~     efficacy of these alternatives in obese PCOS patients.~   "
79852|NCT02521740|"~     Providing care for a disabled elderly may represent a risk for the health of the caregiver.~     The objective of the study is to assess the impact of caregiving in terms of clinical and~     biological markers in relation to disability and cognitive impairment.~   "
79853|NCT02521727|"~     The risk of CRC in families of patients with CRC is well established, but it is less~     well-defined for families of patients with adenomas. Screening recommendations to families~     when an index subject has an adenoma on colonoscopy are not clear. Previous studies~     demonstrating an increased CRC risk in close relatives of subjects with adenomas were mostly~     limited by the lack of a suitable comparison group, did not offer colonoscopy to all~     relatives or did not have verification on true status of adenoma history in the relatives. A~     systematic review has reported that most studies cited for risk of CRC in relatives with~     adenomas have not addressed the intended question. Currently International guidelines~     recommended screening colonoscopy in close relatives and at a younger age when there is a~     proband with an adenoma, however this recommendation has not been fully supported by all~     societies due to the lack of robust evidence. This gap in knowledge highlights the need of~     well-designed and adequately powered studies to estimate the risk of colorectal neoplasms in~     subjects who have first-degree relatives with adenomas.~      Up to 30% of average risk asymptomatic individuals 50 years or older will have at least one~     adenoma. Based on current guidelines, nearly half the population will be counseled to undergo~     a colonoscopy from 40 years old based on a positive family history of adenoma. This will have~     enormous burden on the healthcare system if screening is implicated in all these individuals.~     Secondly, not all adenomas carry the same risk. Large or villous adenomas are associated with~     a nearly 70% increased risk of CRC in first degree relatives (FDR) whereas small adenomas may~     be associated with a modest increased risk 19. It is therefore important to determine the~     risk of colorectal neoplasms in families of subjects with non-advanced adenomas to justify~     more intensive screening in these individuals. Investigators hypothesize that first-degree~     relatives of patients with non-advanced adenoma have an increased risk of both CRC and~     adenomas. Investigators aim to quantify this risk, and to identify other individual patient~     or neoplasm characteristics that may contribute to this increased risk. In addition,~     Investigators aim to determine molecular alteration profiles of colonic adenoma in siblings~     of patients with advanced neoplasm.~   "
79854|NCT02521714|"~     This study will evaluate the amount of drug that reaches the circulation when a subject takes~     the test (liquid) formulation compared to the reference (capsule) formulation. The study will~     also examine the effect of a high fat meal on the levels of drug in blood.~   "
79855|NCT02521701|"~     This Phase I study is to investigate the safety of two dose levels of NFL-101 in smokers.~   "
79856|NCT02521688|"~     Investigators have shown the presence of elevated proinflammatory cytokines in amniotic fluid~     in patients in preterm labor.However, there is limited and mostly negative evidence that the~     elevation of these mediators in gingival crevicular fluid (GCF), and amniotic fluid are~     associated with pregnancy complications in periodontitis patients. Thus this case control~     study will be conducted to~        1. To determine the level of proinflammatory cytokines in gingival crevicular fluid in~          women with spontaneous preterm delivery with chronic periodontitis.~        2. To investigate the expression of macrophage inflammatory protein-1α in placental~          tissues.~        3. To assess the possible correlation between chronic periodontitis and preterm delivery.~   "
79857|NCT02521675|"~     There is no specific recommendations on the adjustments of the insulin treatment in the event~     of physical activity (PA) in T1D patients treated on insulin pump therapy. Patients often~     prefer additional carbohydrates intake rather than the reduction of their insulin doses~     because of the lack of specific algorithms.~      The DIABRASPORT 2 study aims to demonstrate that using algorithms DIABRASPORT, during a week~     of physical activity (PA), the incidence of hypoglycaemia is not different from that obtained~     during a week of rest without physical activity.~      It is a multi-center European, controlled, randomized, cross-over, study, in 100 T1D patients~     practicing an occasional AP.~      25 centers involved in this study.~      After agreeing to participate in the study, patients will read the information leaflet, ask~     questions to the investigator physician and they will date and sign the consent form. The~     investigator physician will do the same.~      They will be then drawn randomly via the electronic CRF (eCRF) to determine the order in~     which they will realize the rest vs DIABRASPORT sessions.~      The study will take place in 5 weeks:~      During the weeks Baseline and Diabrasport, patients will have to make 3 physical activity of~     30 to 60 minutes separated by at least 24 hours:~        -  moderate activity 3 hours after lunch~        -  intense activity 3 hours after lunch~        -  activity moderate 90 min after lunch They will use their usual algorithms (Cho intake or~          adjustment of the dose of insulin) during the week Baseline and they will use the~          Diabrasport algorithm during the week Diabrasport.~      Patients will be equipped with a holter Glycemic iPro2, Medtronic, whose data are hidden.~      During the week of rest, patients should do no physical activity during the week. They will~     be equipped with the Glycemic holter.~      Patients will have to fill a food survey the days they practice PA. Between each period, the~     patient must respect a period of wash-out for one week at least, during which he will be~     asked to not practice physical activity.~      Validation of algorithms simple, easy to implement, adaptable by patients, could help to~     improve balance metabolic and practice of sport among the T1D.~   "
79858|NCT02521662|"~     A randomised trial to determine whether e-cigarettes (with and without nicotine) combined~     with nicotine patches and behavioural support can assist smokers in remaining abstinent for~     at least six months.~   "
79859|NCT02521649|"~     An open, dose-ranging, multiple dose, multi-centre study in patients with Stage I-III or~     Stage IV gastric cancer. Twelve patients in each of 5 treatment groups were to receive three~     injections at weeks 0, 2 and 6 with provision for a single booster injection in an extension~     study period.~   "
79860|NCT02521636|"~     Investigators propose to conduct a prospective, randomized, controlled, multicenter assessing~     the interests of an antibiotic protocol guided by serum procalcitonin (PCT) on morbidity and~     mortality in patients with chronic obstructive pulmonary disease (COPD) hospitalized in~     intensive care unit (ICU) for acute exacerbation with or without associated pneumonia. The~     main objective is to show in patients hospitalized in intensive care for acute exacerbation~     of COPD with or without pneumonia, safety, defined as a lack of difference in mortality at 3~     months, an antibiotic strategy guided by the PCT in the ICU.~   "
79861|NCT02521623|"~     An increasing number of women undergo an immediate breast reconstruction, where the~     mastectomy and the breast reconstruction are performed in the same surgery. To aid survival~     of the mastectomy skin flaps, and to provide better aesthetic results acellular dermal~     matrixes (ADMs) are used to reinforce the breast. There are several different types of ADM~     available for this purpose. In this randomized clinical trial, the following study will~     investigate two different types of ADM (Strattice™ and SurgiMend®) in an immediate breast~     reconstructive setting. Sixty patients will be allocated on a 1:1 ratio to receive either~     Strattice™ or SurgiMend® ADM. Patients scheduled for immediate breast reconstruction with ADM~     at pt. of Plastic and Reconstructive Surgery at Aarhus University Hospital, Aarhus, Denmark~     will be offered participation. In total, 60 patients will be included. Outcome parameters of~     interest are complication rate, patient satisfaction, aesthetic result and cost of the~     procedure. Satisfaction and aesthetic result will be measured at 4 and 12 months post~     surgery.~   "
79862|NCT02521610|"~     This randomized, double-blind, placebo-controlled, ascending-dose, parallel-group study will~     evaluate the pharmacodynamic effects, pharmacokinetics, safety, and tolerability of one week~     of RG7625 dosing in healthy male and female volunteers. Each participant will receive a~     single dose of RG7625 or placebo followed by one week of dosing with the same treatment. Each~     participant will also receive intradermal administration of 4 recall antigens at Screening~     and on Day 7 of treatment to assess study drug effects on delayed-type hypersensitivity~     (DTH).~   "
79863|NCT02521597|"~     To evaluate the residents' efficacy in diagnosing acute otitis media among febrile children~     presenting with respiratory symptoms using a smartphone otoscope attachment compared with a~     classic otoscope.~   "
79864|NCT02521584|"~     Study the effect of ischemia time on patient and graft survival.~   "
79865|NCT02521571|"~     The Resilience Alliance is a skill-based staff development intervention for child protective~     staff that focuses on improving job satisfaction, resilience, optimism and social support,~     while decreasing attrition, stress reactivity and burnout. The investigators believe that the~     intervention will enhance the capacity of child welfare workers to care for themselves, which~     will result in them providing better care for the children and families involved with the~     child welfare system.~      The Resiliance Alliance will be implemented in two child protective offices, Manhattan Zone C~     and Brooklyn Zone B. Staff from two additional offices (Staten Island Zone A and Brooklyn~     Zone C) will serve as a control group. A web-based survey will be administered in the group~     receiving the Resiliance Alliance intervention prior to intervention, at completion of the~     intervention, and 3 months post completion. The control group will be given a two-part~     training (3 hours in total) on secondary traumatic stress. The control group will then be~     asked to complete the same survey as the intervention group.~   "
79866|NCT02521558|"~     The current study will examine the use of a mobile electronic application used to deliver~     cognitive rehabilitation to patients with mild cognitive impairment due (MCI) due to~     Alzheimer's disease (AD), and patients with mild AD. Patients will be given a specific~     cognitive rehabilitation program on their mobile device (iPad) with specific tasks for them~     to complete. The goal of this study is to determine if a) patients are able to use and adhere~     to a cognitive rehabilitation program delivered to their mobile device and b) to determine if~     patients can improve their language, attention, and memory by completing cognitive~     rehabilitation tasks assigned to them.~   "
79905|NCT02521051|"~     This research study is evaluating two drugs, alectinib and bevacizumab, as possible~     treatments for Advanced Non-Small Cell Lung Cancer (NSCLC).~   "
79868|NCT02521532|"~     Acute consumption of dietary nitrate (as beetroot juice) has been shown to increase exercise~     and decrease systemic blood pressure in multiple populations, including COPD. The chronic~     effect of dietary nitrate in obstructive sleep apnea syndrome (OSAS) has not been reported.~   "
79869|NCT02521519|"~     This study compares the efficacy of medial branch block (MBB) vs. paravertebral deep~     intramuscular (PDI) injection for pain relief in chronic low back pain. Based on~     randomization in first intervention session, one side receives MBB and the other side takes~     PDI and in second session the pattern reverses.~   "
79870|NCT02521506|"~     Diabetes mellitus is one of the most prevalent disease in the western world. The control of~     glucose levels has a big impact in the prevention of diabetes complications. The measure of~     glucose levels in capillary blood with glucometers is the gold standard to measure and~     control the glucose levels. Nowadays the glucometers become to more precise and sophisticated~     devices. One of the most notables advance is the inclusion of software that cam predicts~     glucose trends. This software has not be tested in routine clinical practice.~   "
79871|NCT02521493|"~     This phase III trial studies response-based chemotherapy in treating newly diagnosed acute~     myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome. Drugs~     used in chemotherapy work in different ways to stop the growth of cancer cells, either by~     killing the cells, by stopping them from dividing, or by stopping them from spreading.~     Response-based chemotherapy separates patients into different risk groups and treats them~     according to how they respond to the first course of treatment (Induction I). Response-based~     treatment may be effective in treating acute myeloid leukemia or myelodysplastic syndrome in~     younger patients with Down syndrome while reducing the side effects.~   "
79872|NCT02521480|"~     To determine whether real TMS is more effective than sham TMS in reducing pain following~     surgery~   "
79873|NCT02521467|"~     Free gingival grafts are important to increase zone of attached gingiva and root coverage.~     This case series reveals role of platelet-rich fibrin (PRF) as adjunctive therapy in palatal~     wound healing. The superior healing observed at the PRF membrane sites supports its use in~     accelerating soft-tissue healing. PRF membrane as a palatal bandage is an efficacious~     approach to protect the raw wound area of a palatal donor site to reduce healing time and~     patient discomfort.~   "
79874|NCT02521454|"~     Successful policing requires rapid and unbiased decision-making, well-developed emotion~     regulation skills, and psychological resilience. However, law enforcement officers (LEOs) are~     frequently exposed to intensive work-related stress and trauma, and consequently, are at~     elevated risk of adverse mental health outcomes. These mental health issues in turn are some~     of the primary mechanisms underlying other- and self-directed violence among LEOs. The~     excessive use of force by LEOs, including unjustified shootings, frequently captures national~     headlines and is considered by many to be one of the most serious and divisive human rights~     issues in the United States. Previous research suggests that LEOs can be impacted by various~     factors when making rapid decisions while using firearms, including a lack of careful~     consideration of contextual factors and unconscious racial stereotypes. This is especially~     true when their cognitive and emotional resources are compromised due to factors such as~     stress. Similarly, key precursors to suicide among LEOs include chronic stress, exposure to~     trauma, alcohol misuse, and depression. The substantial personal, social, and economic costs~     of LEO stress, including unjustified shootings and suicide, suggest a clear need for~     innovative and novel prevention programs to promote well-being and reduce violence. Given its~     demonstrated impact on many of the precursors to self- and other-directed violence among~     LEOs, one possible approach is an adapted Mindfulness-Based Stress-Reduction (MBSR) program,~     developed specifically for LEOs. Therefore, the primary objectives of this proposal are to:~     (1) assess the feasibility of recruitment, adherence to program intervention, and compliance~     with assessment instruments, and (2) determine the impact of an adapted MBSR program~     (Mindfulness-Based Resilience Training; MBRT) on precursors to other- and self-directed~     violence, and in promoting psychological resilience and emotion regulation among LEOs. There~     is promising preliminary evidence suggesting that mindfulness is an effective strategy for~     LEOs to decrease stress and its negative outcomes, enhance resilience and emotion regulation,~     and ultimately reduce other- and self-directed violence. The proposed project will test the~     impact of MBRT using a pilot feasibility randomized controlled trial (RCT). This research~     will generate important information on the feasibility of recruitment, adherence to program~     intervention, and compliance with assessment instruments, and data obtained through the~     proposed study will build on the investigators existing work to provide support for a larger~     RCT examining the efficacy of MBRT in reducing violence.~   "
79875|NCT02521441|"~     This was a randomized, open-label, active-controlled, dose-finding, phase II study to~     evaluate the efficacy and safety of 2 doses of F-627 compared to Filgrastim in women with~     breast cancer receiving myelotoxic chemotherapy.~      Subjects would be randomized to one of three arms, which were 10 mg/dose of F-627, 20 mg/dose~     of F-627 or Filgrastim, in an equal ratio.~   "
79876|NCT02521428|"~     The purpose of this retrospective observational study is to describe the sequence of~     ICU-therapies that are limited and to compare characteristics and the decision making process~     in surgical ICU-patients.~   "
79877|NCT02521415|"~     This single center, randomized control, double blind trial will prospectively examine the~     feasibility of intranasal, sub-dissociative (IN) ketamine versus intranasal fentanyl for pain~     control in the pediatric emergency department setting. The investigators hypothesize that IN~     ketamine may provide a safe and effective alternative to IN fentanyl for children with~     suspected, isolated extremity fractures.~      Eighty children ages 3-17 years with a suspected, isolated extremity fracture that requires~     analgesia will be randomized to receive IN ketamine or IN fentanyl upon presentation to the~     emergency department and will be followed for 2 hours for efficacy and 6 hours for safety.~   "
79878|NCT02521402|"~     The main purpose of this study is to see if there is clinical benefit of using Biovance in~     reduction of the recurrence of keloids when used to revise them. It will also assess the~     postoperative complications.~   "
79879|NCT02521389|"~     This single center first in human (FIH) study will comprise 2 parts; Part 1 will consist of 3~     sequential dose groups (Groups A, B and C) and Part 2 will consist of 1 dose group (Group A).~     There will be an option to include 2 additional dose groups in Part 1 (Groups D and E) to~     assess alternative dose levels or formulations, if required.~      In each study part, each subject will receive a single dose of investigational medicinal~     product PWT-143 in each of 2 study periods (total of 2 single doses).~   "
79880|NCT02521376|"~     The primary objective of this study is to evaluate the pharmacokinetics of entospletinib~     (ENTO) and/or its metabolites (if applicable) in participants with impaired hepatic function~     (stratified by smoking status, as appropriate) relative to matched, healthy controls.~   "
79881|NCT02521363|"~     The purpose of this study is to test the safety and feasibility of placing and removing a~     small device that contains anti-cancer drugs in a breast tumor of patients who plan on having~     breast surgery without treatment prior or patients who plan on receiving standard~     preoperative chemotherapy prior to their breast surgery. This device may be able to predict~     what types of treatment work best against an individual's breast cancer. With this device,~     the investigators hope to be able to personalize treatment choices based on an individual's~     type of breast cancer.~   "
79882|NCT02521350|"~     In the last few years, acute renal injury (AKI) definition has been significantly changed. In~     the light of the data obtained from multicenter international studies, acute renal injury was~     redefined according to RIFLE, AKIN and KDIGO criteria. The common criteria of all three~     criteria in acute renal failure is the increment of level of creatinine as 0.3 mg/dL or 50 %~     increment of respective basal value of serum creatinine.~      In the current study, older than 40 years patients with no specific gender, who will stay at~     least one night in hospital will be included and cardiovascular and urological surgery~     patients and patients with known renal insufficiency will be excluded. It was aimed to~     measure serum creatinine levels in all included patients at baseline and up to 24h after~     surgery and will be determined acute kidney injury incidence and risk factors according to~     new criteria.~   "
79883|NCT02521337|"~     Preterm birth is defined as a birth occurring before the completion of 37 weeks gestation.~     The incidence of preterm birth in Israel in the last years is around 7-8%.~      Despite various diagnostic modalities as well as newly therapeutic approaches the incidence~     of preterm birth remains unchanged and is considered to be the leading cause of neonatal~     morbidity and mortality.~      In the last decade, small RNAs have emerged as an important player in both physiological and~     pathophysiological responses. These single strands, non-coding regulatory RNA molecules are~     responsible for post transcriptional regulation of target genes. Hence, may provide a new~     opportunity for biomarkers discovery in the field of preterm birth.~      The main objective of this study is to identify a distinctive expression profile of maternal~     circulating RNAs that will be used as biomarkers for preterm birth.~   "
79884|NCT02521324|"~     The current study is designed to evaluate the effect of device guided breathing (DGB) on~     sleeplessness. Healthy subjects with mild to moderate sleeplessness that wish to improve~     their sleep quality will be included in this study. The subjects will receive a belt type~     breathing sensor, download the app on their smartphone, and will be required to perform DGB~     at their home setting for 2 weeks after a baseline period.~   "
79885|NCT02521311|"~     The main purpose of this study is to assess clemastine as a remyelinating agent in patients~     with acute optic neuritis.The study will also evaluate the tolerability of clemastine,~     originally approved as first-generation antihistamine, in patients with optic neuritis. Study~     procedures will include assessments for evidence of remyelination in the anterior visual~     pathway and in the brain using electrophysiologic techniques and magnetic resonance imaging.~     If they are on one, patients in this study can remain on their standard disease modifying~     treatment during the course of the study. However, patients cannot participate in any other~     investigational new drug research study concurrently.~   "
79886|NCT02521298|"~     This study investigates the treatment effect on lateral elbow tendinopathy of strength~     training in combination with cortico-steroid injection, dry-needling or placebo in a~     double-blinded randomized controlled trial.~   "
79887|NCT02521285|"~     This randomized phase II trial studies the safety of and how well aspirin works in preventing~     Barrett's esophagus from returning after it has been successfully eliminated by~     radiofrequency ablation. Studying samples of tissue from patients with Barrett's esophagus~     for the levels of a specific protein that is linked to developing Barrett's esophagus may~     help doctors learn whether aspirin can prevent it from returning after it has been~     successfully treated.~   "
79888|NCT02521272|"~     The aim of the study is to investigate respiratory parameters of a person in the simulated~     avalanche snow and consequent use of the measured data for development of a~     mathematical-physical model of breathing during increasing hypercapnia in the avalanche.~   "
79889|NCT02521259|"~     This study evaluates the association between the depth of general anesthesia and the~     occurrence of EA. The investigators hypothesized that optimal level of anesthetic depth could~     decrease the incidence of EA in children undergoing strabismus surgery compared to the deep~     level of anesthetic depth.~   "
79890|NCT02521246|"~     The purpose of this study is to evaluate the non-inferiority clinical efficacy of two~     different drug associations in the essential hypertension control.~   "
79891|NCT02521233|"~     The purpose of this study is to evaluate the non-inferiority clinical efficacy of two~     different drug associations in the essential hypertension control.~   "
79892|NCT02521220|"~     Some studies have reported improved vascular function with the supplementation of L-arginine~     in participants with cardiovascular disease (CVD). Several clinical studies have also begun~     the investigation of L-arginine supplementation in participants with peripheral artery~     disease (PAD). This is particularly important as currently there are limited options~     available to medically manage intermittent leg pain resulted from PAD. Although some of these~     short-term clinical trials suggested that oral L-arginine improved walking distance or~     improved walking speed in participants with PAD, these results were not consistent. Further,~     only 1% of the oral supplemented L-arginine is available for the NO production as the rest is~     metabolised by the body. A better way to provide the body with substrate to produce NO is~     therefore needed. The natural amino acid and food component, L-citrulline has been suggested~     to be a good candidate for this purpose.~      L-citrulline, named after watermelon citrullus vulgaris from which it was first isolated, is~     a natural precursor of L-arginine. Studies have shown that L-citrulline is metabolised by the~     body to a lesser degree compared to L-arginine and hence is an effective precursor of~     arginine in peripheral tissues, including endothelial cells. Oral L-citrulline~     supplementation also eliminates some of the unwanted effects associated with oral arginine~     supplementation and it is well tolerated without known side effects. In addition,~     L-citrulline is a supplement that is available over-the-counter. Thus, oral supplementation~     of L-citrulline may be a new intervention strategy in participants with PAD.~      The investigators hypothesize that the oral food supplement L-citrulline, unlike L-arginine,~     reverses endothelial dysfunction. In a multinational, multicenter, double blinded,~     randomised, placebo-controlled cross-over trial the effects of L-citrulline in peripheral~     artery disease will be investigated.~   "
79893|NCT02521207|"~     The study will compare the study drug to an already marketed formulation of prescription~     strength ibuprofen (Brufen® the reference product) by looking at how the drug is taken up by~     the body and also by performing a specialist procedure called an endoscopy (or more~     specifically, a gastroscopy). The safety and tolerability of the study drug will also be~     assessed.~      The study will consist of 2 parts involving up to 54 healthy male and female subjects.~     Subjects will be randomly assigned to receive either the study drug or reference product.~     Part 1 will be a cross over study in which up to 10 subjects will receive a single dose of~     800 mg study drug OXP001 or Brufen® on Day 1, then a single dose of 800 mg study drug OXP001~     or Brufen® on Day 4. Part 1 will assess bioavailability and involve an interim decision on~     progression to Part 2. In Part 2, up to 44 subjects will receive a dose of 800 mg OXP001 or~     Brufen® three times daily for 7 days in order to assess pharmacokinetics and stomach~     irritation using endoscopy.~   "
79894|NCT02521194|"~     The goal of this research study is to learn if inpatient occupational therapy can help~     patients in the Palliative Care Unit (PCU).~   "
79895|NCT02521181|"~     The two doses of sodium bicarbonate being tested are 0.5 and 0.8 mEq/kg-lean body weight~     (LBW) per day. Sodium bicarbonate, also known as baking soda, may help prevent kidney failure~     in people with chronic kidney disease. However, the dose to prescribe in order to test this~     possibility in a clinical trial is uncertain. The BASE pilot clinical trial will help~     determine the best dose of sodium bicarbonate to prescribe in a future study that will test~     the long-term safety and efficacy of sodium bicarbonate as a treatment to preserve kidney~     function in individuals with chronic kidney disease.~   "
79896|NCT02521168|"~     A condition of decreased serum T3 level in children after cardiac surgery using~     cardiopulmonary bypass has been commonly recognized as euthyroid sick syndrome (ESS). This~     syndrome has been closely associated with low cardiac output syndrome after heart surgery.~     The unique characteristics of pediatric patients with congenital heart disease (CHD) in~     Indonesia have caused ESS to arise in the population even before surgical managements.~     Thyroid hormones increase cardiac function, respiration and diuresis. Increased myocardial~     function occurred through the improvement of mitochondrial effectiveness as the body energy~     source by utilizing effective energy substrates, lactate and pyruvate. Prevention of~     decreased serum thyroid hormones level by T3 supplementation could be clinically beneficial.~     Intravenous T3 unit dose is very expensive and inapplicable for daily use. In adult studies,~     oral T3 was found to be effective for the prevention of decreased serum T3 levels; similar~     study on pediatric population, however, has not been elucidated.~   "
79897|NCT02521155|"~     The purpose of the investigators' study is to assess effectiveness of community based oral~     health literacy intervention promoting positive oral hygiene self-care behavior among~     Montreal's Punjabi immigrants.~   "
79898|NCT02521142|"~     Age-related macular degeneration (AMD) is the leading cause of severe and irreversible visual~     loss and classified blindness in the elderly throughout Europe and the US. Among these~     patients, about 6%-8% are afflicted with the advanced stages of AMD, which are responsible~     for the most severe visual loss. There is now convincing evidence that vascular endothelial~     growth factor (VEGF) is a major trigger for the formation of pathological choroidal vessels,~     responsible for the development of the neovascular form of AMD. Today, the gold standard for~     vascular imaging of the retina and diagnosis of CNV is angiography using fluorescein (FLA) or~     indocyanine green (ICG), which involves injection of the dye into a vein of the arm. In the~     recent years tremendous enhancements in the field of optical coherence tomography have been~     achieved. These developments made it possible to visualize the retinal vasculature in a full~     depth manner without the application of an intravenous marker. The proposed study tests the~     hypothesis that visualisation of CNV lesion size with non-invasive OCT angiography is not~     inferior to FLA/ICG angiography in treatment naïve and previously treated AMD patients.~   "
79899|NCT02521129|"~     The purpose of this study is to evaluate the effectiveness and safety of a new biopsy track~     ablation device for liver biopsy.~   "
79900|NCT02521116|"~     To date two different instruments are commercially available to measure retinal oxygen~     saturation and retinal vessel diameters: Dynamic Vessel Analyzer (DVA) and Oxymap. Retinal~     oxygen saturation analysis is based on spectroscopic evaluation of retinal fundus images. Up~     to now no data comparing both instruments for the measurement of retinal oxygen saturation~     and vessel diameter are available in the literature.~      Study objectives: To compare retinal oxygenation and retinal vessel diameters in healthy~     subjects and patients with diabetic retinopathy or retinal vein occlusion between 2~     commercially available systems (DVA, Oxymap T1)~      Study design: Open pilot study~      Study population:~      30 healthy volunteers, age 18-80 years 30 type 2 diabetic patients with mild or moderate~     non-proliferative diabetic retinopathy, age 18-80 years 30 patients with retinal vein~     occlusion, age 18-80 years~      Topically administered medication:~      Tropicamide (Mydriaticum Agepha®, Agepha, Vienna, Austria), dose: 1-2 drops per study day~     for dilation of the pupil Oxybuprocainhydrochloride combined with sodium fluorescein~     (Thilorbin®, Alcon Pharma GmbH, Freiburg, Germany), dose: 1 drop in one eye for measurements~     of intraocular pressure Nonylacidvanillylamide combined with~     Nicotinic-acid--ß-butoxyethylester (Finalgon®, Boehringer Ingelheim RCV GmbH & Co KG, Vienna,~     Austria): topical on the earlobe~      Methods:~      Dynamic vessel analyzer Oxymap T1 Blood pressure and pulse rate measurement Applanation~     tonometry Oxygen and carbon dioxide partial pressure measurement in arterialized blood from~     earlobe~      Main outcome variables:~      Difference of oxygen saturation of retinal vessels between DVA and Oxymap T1~      The motive for this investigation is to compare data between 2 commercially available~     instruments for the measurement of retinal oxygen saturation and retinal vessel diameter in~     healthy subjects as well as in patients with ocular disease associated with altered retinal~     oxygenation. Comparative data from both systems are currently not available. Data from this~     study will allow the comparison of studies performed with different systems. All oxygen~     measurement procedures are non-invasive and painless. Hence, the risk/benefit ratio appears~     to be acceptable.~   "
79901|NCT02521103|"~     This study is a prospective, open-label, post-market, non-randomized, multi-center clinical~     evaluation of the Triathlon TS Total Knee System with Triathlon Tritanium Cone Augments for~     revision total knee arthroplasty (TKA) in a consecutive series of patients who meet the~     eligibility criteria. The revision rate of the Triathlon Tritanium Cone Augments is expected~     to be less than 2.8% for aseptic loosening of either the Femoral or the Tibial Cone Augments~     at 2 years postoperative.~   "
79902|NCT02521090|"~     This phase I/II trial studies the side effects and best dose of epidermal growth factor~     receptor bispecific antibody (EGFRBi)-armed autologous T cells and how well it works in~     treating patients with glioblastoma that have come back or does not respond to treatment.~     EGFRBi-armed autologous T cells coated with antibodies (proteins used by the immune system to~     target and kill foreign objects such as cancer cells) may have great ability to seek out,~     attach to, and destroy glioblastoma cells.~   "
79903|NCT02521077|"~     This is a parallel-track, randomized study will observe whether intravenous ascorbic acid~     reduces the reported fatigue in women receiving adjuvant or neo-adjuvant chemotherapy for~     early stage breast cancer.~   "
79904|NCT02521064|"~     Children with Crohn's disease can be effectively treated by remaining on a single-formula~     diet for 8 continuous weeks. This dietary therapy is known as exclusive enteral nutrition~     (EEN). It is just as effective as steroid treatment, which is what's traditionally used for~     the initial treatment of Crohn's disease. It is not clear why EEN is an effective treated.~     One possibility is that it changes the bacteria in our intestines, which allows the intestine~     to heal. It is also unclear whether EEN can be used to treat ulcerative colitis, a disease~     that is very similar to Crohn's disease. The purpose of our research project is to determine~     whether EEN can be used to treat ulcerative colitis, and understand how the intestinal~     bacteria changes while on EEN. Investigators will compare the results to patients who have~     either Crohn's disease or ulcerative colitis, and are receiving standard treatment for their~     disease (steroids). This is a pilot study, meaning that the goal of this study is to~     determine whether a larger study is feasible. Investigators will measure patient recruitment~     rates, whether patients are able to perform the treatment as requested, whether there are any~     safety concerns, and whether investigators are able to collect the bloodwork and stool~     samples without difficulty.~   "
79906|NCT02521038|"~     Patients with acute coronary syndrome (ACS) require platelet inhibition after treatment.~     P2Y12 receptor blockage is a well-known, proved method of urgent and effective blockade of~     the platelet activation, and is applied to the current practice protocol. Ticagrelor is a~     well-performing P2Y12 receptor blocking agent which is used in these patients. In the same~     matter, it is essential to prescribe the exact dosage to optimize efficacy within the safety~     limits. However current studies are based on Western countries, whereas there has been no~     Ticagrelor patient registry in East-Asia. Thus it is reasonable to study the use of~     Ticagrelor in a large registry of Korean ACS patients.~      The BK registry is a Prospective, Open-label, Multi-center, Real world, Registry, with~     prospective registration of patients receiving the medication, Ticagrelor. All subjects are~     to be followed up for 18 months after diagnosis and treatment for ACS.~      The purpose of this study is to observe and register clinical data including Major Adverse~     Cardiovascular Endpoints and any total bleeding occurrence in Korean ACS patients treated~     with Ticagrelor during 18 month follow-up. Also, the purpose includes to determine compliance~     of Ticagrelor during post-approval commercial use and to determine prescription pattern of~     Ticagrelor during post-approval commercial use.~   "
79907|NCT02521025|"~     In the present study, the investigators will assess the impact of two different feeding~     patterns (continuous vs intermittent) on insulin sensitivity and muscle mass following~     bedrest.~   "
79908|NCT02521012|"~     Depression affects 350 million people worldwide. In the light of the global disease burden~     statistics, the efficacy of current treatments for depression appears insufficient. Thus,~     research on novel treatment interventions and predictors for good treatment response are~     warranted. Earlier prospective follow-up studies and intervention studies suggest that~     several bio-psychosocial factors, including high serum concentrations of vitamin D, are~     related to better treatment outcomes. In this follow-up study with randomized clinical~     vitamin D supplementation trial on patients with depression, the investigators aim to~        1. clarify how a six-month intervention with vitamin D supplementation affects treatment~          response, recovery, and the biological pathways related to depression. This aims to~          finding potential sub-groups getting benefits from vitamin D supplementation. In~          addition, the investigators want to~        2. investigate and characterize factors related to recovery from depression and working~          ability in depression patients in the long-term. The investigators are especially~          interested in the bio-psychosocial factors and the aims include examining both the~          individual's positive resources.~      The trial will start with a six-month double-blinded randomized controlled trial with vitamin~     D supplementation. The aim is to recruit altogether 3028 patients with non-psychotic,~     unipolar depression, aged 18-65 years, who are referred to the recruitment sites for~     treatment for depression. The participants will be randomized to low (10 µg/day) or high (100~     µg/day) vitamin D supplementation group. Clinically necessary antidepressant treatments will~     continue during the intervention as needed. After six months of intervention, the~     participants will be followed up at 18 months and at 5 years.~      Several measurements will be conducted during the intervention and follow-up period.~     Participants will fill a variety of clinical questionnaires and questionnaires with~     background information. All participants give blood samples for biomarker analyses at time~     points 3, 6, 18 months and 5 years. Clinical interviews of mental disorders (e.g. SCID) and~     anthropometric measurements (e.g. weight, height, blood pressure) will be carried out.~   "
79909|NCT02520999|"~     Rapid infusion of blood is needed occasionally for control massive bleeding. For rapid~     infusion, external pressure can be used. The investigators will study correlation between~     external pressure and hemolysis and deformability of red blood cell.~   "
79910|NCT02520986|"~     In a randomized clinical trial of 114 women undergoing Treatment for condyloma acuminata, two~     surgical methods, the carbon dioxide laser Ablation and the excision by electrocoagulation,~     will be compared. The primary outcome of the study is the cosmetic result judged by the~     Patient 6 weeks after Treatment using a 11-step visual analogue scale (VAS), secondary~     outcomes are intervention time, operative complications, subjects and users satisfaction,~     postoperative pain and recurrence of genital warts.~   "
79911|NCT02520973|"~     Pregnant women who develop active Tuberculosis (TB) are at increased risk of poor maternal~     and infant outcomes. Our data from South Africa show that up to 3% of HIV-infected pregnant~     women have active TB , many with advanced disease, contributing to the 40% of maternal~     mortality associated with TB or HIV in South Africa . Screening for TB in pregnant women in~     this setting is therefore essential to reduce maternal mortality. Symptom-directed screening~     for TB has been recommended by the World Health Organization and by the South African~     National Department of Health; however, no implementation framework is in place to~     operationalize the guidelines. Symptom-based testing is an efficient process that limits use~     of diagnostic tests, but may miss many cases. In Soweto, we found that 0.7% (700/100,000) of~     HIV-infected women had active TB when a symptom-based strategy was employed once, but in~     Klerksdorp we found that 3.3% (3,300/100,000) had active TB when universal testing,~     regardless of symptoms, was performed; most TB cases were newly diagnosed among women who~     reported no symptoms .~   "
79912|NCT02520960|"~     Prospective observational multicentric study evaluating the efficacy of considering unipolar~     signal modification during radio frequency catheter ablation of patients with symptomatic~     paroxysmal atrial fibrillation in France between November 2013 and January 2015. All~     procedures were conducted according to the standard clinical care and current guidelines.~     Pulmonary vein isolation was guided according to force (at least 10 grams) and application~     vector (perpendicular to the wall) developed until the atrial unipolar electrogram recording~     became a complete positive signal. Patients were discharged from hospital free of any~     anti-arrhythmic drugs. Recurrence of arrhythmias at 12 months (primary outcome) was assessed~     by continuous 48-hour Holter at 1, 3, 6, 9 and 12 months post-catheter ablation.~   "
79913|NCT02520947|"~     213 patients undergoing elective on-pump coronary artery bypass grafting (CABG) were enrolled~     into this prospective-clinical trial.After hundred and sixty three patients were excluded due~     to various reasons, 50 patients were randomized to BIS (bispectral index) and MAC (minimum~     alveolar concentration) groups. In BIS group (Group B, n=25), desflurane was titrated within~     40 to 60 BIS values and in MAC group (Group M, n=25) within 0.7 to 1.3 MAC. Primary end point~     of the study was to investigate the difference of desflurane consumption between groups.~   "
79914|NCT02520934|"~     evaluate the combination therapy with Miglustat and enzyme replacement therapy (ERT) on~     Gaucher disease~   "
79915|NCT02520921|"~     To compare treatment with enteric coated aspirin twice a day (100 mg in the morning and 100~     mg in the evening) versus enteric coated aspirin 100 mg once per day on a composite end-point~     of ischemic events in diabetic patients with acute coronary syndrome.~      It is expected that aspirin taken twice a day will reduce the occurrence of new ischemic~     event after acute coronary syndrome in diabetic patients.~   "
79924|NCT02520804|"~     The purpose of this study is to determine Acute kidney injury incidence between sterofundin~     and normal saline ; Resuscitation shock patients~   "
82613|NCT02485600|"~     This is an open-label, postmarketing, observational study to document health outcomes, in~     Canadian patients with advanced Parkinson's disease and long-term treatment with Duodopa~     (levodopa/carbidopa intestinal gel).~   "
79916|NCT02520908|"~     Epidermotropic T-cell lymphomas (ETCL), i.e. mycosis fungoides (MF) and its leukemic variant,~     Sézary syndrome, are the most frequent subtypes of cutaneous T-cell lymphomas. MF typically~     runs an indolent course in its early stages. By contrast, advanced-stage ETCLs share a very~     bad prognosis: Patients usually show early relapses after chemotherapy, prolonged complete~     remissions exceptionally occur and quality of life is severely affected. Several publications~     have reported durable responses following allogeneic hematopoietic stem cell transplantation~     (HSCT) in advanced-stage ETCLs. This study aims to investigate the role of allogeneic HSCT in~     treating advanced-stage ETCLs. An observational, prospective, multicenter, controlled study~     will compare the outcomes of patients who receive reduced-intensity conditioned allogeneic~     HSCT from a sibling or 10/10 HLA-matched unrelated donor to those of patients who receive~     standard of care in patients with advanced-stage ETCL with poor prognostic features, will be~     performed. Patients are included at the time of donor search irrespective of the results, and~     compared on a donor versus no donor basis. It is an observational study since no intervention~     is made except the comparison of outcomes of groups that receive usual care (HSCT if donor~     available, or not).~   "
79917|NCT02520895|"~     RIPAL is a prospective cohort study, which main goal is to define T and B immune repertoire~     diversity and magnitude in patients with non-Hodgkin lymphoma of high and low grade and~     chronic lymphocytic leukemia before and after treatment, and to evaluate the association of~     these parameters with clinical patient data and outcomes.~   "
79918|NCT02520882|"~     This is an open-label positron emission tomography/computed tomography (PET/CT) study to~     investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-Aca-BBN(7-14) in~     glioma patients. A single dose of 111-148 Mega-Becquerel (MBq) 68Ga-NOTA-Aca-BBN(7-14) will~     be injected intravenously. Visual and semiquantitative method will be used to assess the~     PET/CT images.~   "
79919|NCT02520869|"~     All patients will go through an ICSI (intracytoplasmic sperm injection)cycle Monitoring: COH~     (controlled ovarian hyperstimulation) will be monitored by transvaginal sonography, and then~     the dose of gonadotropin will be adjusted according to the follicle size and number.~      Triggering ovulation: when three or more follicles reach >18mm, endometrium triple line >8mm,~     both the gonadotropin and agonist injections will be stopped and 10,000 IU of hCG(human~     chorionic gonadotropin ) will be given.~      Egg collection : 34-36 hour after hCG injection, embryo transfer :48-72 hour after oocyte~     retrieval. Luteal phase support: with 100 mg progesterone injection IM daily until the day of~     the pregnancy test pregnancy test: 15 days after the embryo transfer. Semen collection and~     preparation Semen samples will be collected by masturbation in clean containers, usually~     after 2-3 days of abstinence. Each sample will be allowed to liquefy for at least 20 min at~     37 °C.~      Semen analysis:~      Basic sperm parameters including sperm count, concentration, motility and morphology will be~     evaluated according to World Health Organization guidelines. After the initial assessment,~     ejaculates will be divided into three aliquots. An aliquot of each sample will be used to~     assess sperm DNA damage, the second aliquot will be processed by direct swim-up technique (n~     30) or zeta test technique (n 30) this will be followed by assessment of DNA damage again in~     each sample to measure the difference in DNA damage after processing in each technique then~     spermatozoa from the third aliquot will be morphologically analyzed manually using Spermic~     stain and a light microscope and will be scored according to WHO~   "
79920|NCT02520856|"~     Hypertrophic cardiomyopathy (HCM) is an autosomal dominant disease characterized by~     unexplained hypertrophy of the left ventricle, often with predominant involvement of the~     interventricular septum, and characterized by myocyte disarray and fibrosis.~      HCM is the most common familial heart disease with strong genetic heterogeneity, demonstrated~     over the past 20 years. Mutations in 11 or more genes encoding proteins of the cardiac~     sarcomere are responsible for (or associated with) HCM.~      However, 30-40% of sporadic and familial cases of HCM are still genetically unlabelled. In~     addition, secondary HCM caused by Fabry's disease or amyloidosis, may mimic primary HCM and~     may be under diagnosed. This may result in a delay in accurate diagnosis and instauration of~     specific treatment, with possible clinical consequences for the patients.~      For these reasons, we decided to apply a new diagnostic strategy for patients with newly~     diagnosed HCM, including the whole exome sequencing (WES) technology.~      If correctly applied, this new technology has the potential to strongly reduce the diagnostic~     wavering leading to earlier diagnosis and genetic counseling in sarcomeric HCM and rarer~     forms of secondary HCM including Fabry's disease and amyloidosis, and also specific therapy~     set-up in secondary forms of HCM. It should also allow identifying new genes responsible for~     HCM.~   "
79921|NCT02520843|"~     Crohn's disease is a chronic inflammation of all or part of the digestive tract,  from the~     mouth to the anus . .~      Cell therapy is a new and promising approach for the treatment of inflammatory disease~     including Crohn's disease and fistulas.~      Adipose tissue seems to be an ideal source for cell therapy. This is a prospective, open,~     non-comparative, single center, phase I-II clinical trial. It will involve 10 patients and~     will be conducted over a period of 28 month.~      This protocol is designed to evaluate, in patients with Crohn's disease and fistula-in-ano~     refractory to conventional medical and surgical treatment, the safety and efficacy of local~     microinjection of autologous adipose tissue and SVF from microaspirate .~      The main objective is to assess tolerance and security. The secondary objective is to~     evaluate the effectiveness of this technique~   "
79922|NCT02520830|"~     Diets rich in fruits and vegetables have been linked to favorable cardiovascular outcomes in~     epidemiological studies.~      Dietary intervention studies with certain micronutrients have shown promising effects on~     surrogate parameters of vascular risk including blood pressure, endothelial function and~     cholesterol levels. Wild blueberries have gained attention due to their high content of~     phytochemicals and particularly anthocyanins. Whether wild blueberries can improve vascular~     function and health when given over relevant time periods and in relevant populations is not~     known. Therefore, it is the overall hypothesis of the study proposal that chronic consumption~     of wild blueberries can improve endothelial function, a prognostically validated surrogate of~     cardiovascular risk.~   "
79923|NCT02520817|"~     Minimal hepatic encephalopathy (MHE) can have a far-reaching impact on quality and ability to~     function in daily life and may progress to overt Hepatic Encephalopathy. Patients with MHE~     were missed in clinical follow up and are more exposure to work accident. The aim of the~     present study was to assess the effects of oral supplementation of antioxidant and zinc~     gluconate Versus Lactulose inTruck driver cirrhotic patients with MHE.~   "
79925|NCT02520791|"~     This phase I trial studies the side effects and best dose of anti-inducible T-cell~     co-stimulator (ICOS) monoclonal antibody MEDI-570 in treating patients with peripheral T-cell~     lymphoma follicular variant or angioimmunblastic T-cell lymphoma that has returned after a~     period of improvement (relapsed) or has not responded to previous treatment (refractory).~     Monoclonal antibodies, such as anti-ICOS monoclonal antibody MEDI-570, may block cancer~     growth in different ways by targeting certain cells.~   "
79926|NCT02520778|"~     This phase Ib trial studies the side effects and best dose of osimertinib and navitoclax when~     given together and to see how well they work in treating patients with previously treated~     epidermal growth factor receptor (EGFR)-positive non-small cell lung cancer that has spread~     to other places in the body or has not responded to previous treatment with initial EGFR~     kinase inhibitor. Osimertinib and navitoclax may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth. Giving with osimertinib together with navitoclax~     may work better in treating EGFR-positive non-small cell lung cancer.~   "
79927|NCT02520765|"~     This study is designed to assess the accuracy of Body Mass Index ,Waist Circumference ,Waist~     Hip Ratio or Waist Height Ratio as a predictor of ovarian response in women undergoing ICSI.~   "
79928|NCT02520752|"~     Drg-drug Interaction (DDI) study to assess the effect of INC280 on the pharmacokinetics of~     midazolam and caffeine in patients with cMET-dysregulated advanced solid tumors~   "
79929|NCT02520739|"~     The Mediterranean diet, in which olive oil is the main source of fat, has shown to be~     protective for chronic degenerative diseases. These diseases, such as cardiovascular, cancer,~     and neurodegenerative, and even the aging process, are linked to oxidative stress and~     inflammation. Recently, the Prevention through Mediterranean Diet Study has provided for~     first time evidence of the benefits of the Mediterranean diet on the primary prevention of~     cardiovascular disease.~      Olive oil, besides its high content of a healthy fat, the monounsaturated (MUFA) one: the~     oleic acid, has minor components with bioactive properties. The minor components of virgin~     olive oil are classified into two types: the unsaponifiable fraction, defined as the fraction~     extracted with solvents after the saponification of the oil, and the soluble fraction which~     includes the phenolic compounds. The content of the phenolic compounds (polyphenols) of an~     olive oil depends of the variety of the olive fruit, the cultivar, the climate, the ripeness~     of the olive, and the type of processing. Virgin olive oils obtained from the first press of~     centrifugation of the olives are those with high phenolic content. On November 2011, the~     European Food Safety Authority released a claim concerning the benefits of the daily~     ingestion of olive oil rich in phenolic compounds, such as the virgin olive oil. Due to this,~     the need to optimize the olive oil processing in order to obtain high phenolic content olive~     oils is one of the current goals in terms of increasing the nutritional value of an olive~     oil. To obtain an optimized olive oil with high phenolic content (OHPCO) has been one of the~     achievements within the frame of the NUTRAOLEOUM Project.~      However, the healthy properties of the new olive oils (OHPCO and FOO), according to the~     Evidence Based Medicine must be tested in proper clinical randomized trials. New olive oil~     products need to be tested in front of the parental ones (i.e. virgin olive oil obtained by~     common procedures) in order to ensure that their healthy properties are highlighted. This is~     the purpose of the NUTRAOLEUM Study. In order to be able to obtain future health claims from~     EFSA or FDA, for the products, the investigators will also examine the bioavailability in~     humans of the active principles (phenolic compounds and triterpenes) of the olive oils, as~     well as possible basic mechanisms involved in the potential health benefits of the olive oils~     tested.~   "
79930|NCT02520726|"~     This is a randomized, double-blind, placebo-controlled study to determine whether~     administration of sertraline to patients who exhibit acute stress disorder secondary to~     severe burns can contribute to the prevention of post-traumatic stress disorder (PTSD).~   "
79931|NCT02520713|"~     This research study is evaluating the use of specialized testing of solid tumors including~     sequencing. The process of performing these specialized tests is called tumor profiling. The~     tumor profiling may result in identifying changes in genes of the tumor that indicate that a~     particular therapy may have activity. This is called an individualized cancer therapy (iCat)~     recommendation. The results of the tumor profiling and, if applicable, the iCat~     recommendation will be returned.~   "
79932|NCT02520700|"~     Photodynamic therapy (PDT) uses visible light to treat a premalignant condition, called~     actinic keratosis, which results on chronically sun exposed skin such as on a balding scalp.~     A cream is applied containing aminolaevulinic acid or methyl aminolaevulinate and this is~     converted in the cells to the photodegradable product protoporphyrin IX (PpIX). Visible light~     causes the degradation of PpIX resulting in the production of reactive oxygen species and~     then cell death in the actinic keratosis. In conventional PDT a lamp is used to supply the~     visible light. The main draw back to treatment is pain. Recent studies have shown that~     daylight can be used as the source of visible light and is as effective as conventional PDT.~     Patients find this form of treatment less painful and therefore preferable. The reduction in~     pain seen in daylight PDT appears to be related to the fact that no significant quantity of~     PpIX accumulates prior to exposure to the light source and small quantities of PpIX are~     activated continuously during daylight exposure. The drawback of performing daylight PDT in~     Ireland is the climate, both in terms of cloud cover and temperature. The typical daylight~     treatment times is 2 hours and it would be difficult for patients to stay outside in winter,~     spring and autumn. This study investigates the use of an artificial white light source, a~     Maquet PWD 50SF theatre-light, as an alternative.~   "
79933|NCT02520687|"~     High blood pressure in pregnancy affects around 10% of pregnancies, and is associated with~     serious adverse outcomes for both mother and baby. Treatment options for the management of~     high blood pressure in pregnancy are currently limited. Studies in non-pregnant individuals~     have shown that supplementation with dietary nitrate, using beetroot juice, can significantly~     lower blood pressure and improve blood flow. This study aims to investigate whether~     supplementation with dietary nitrate (via beetroot juice) can improve blood pressure~     regulation in pregnant women with chronic high blood pressure, and will also determine~     whether this can improve blood flow across the placenta.~   "
79934|NCT02520674|"~     The purpose of this study is to assess the accuracy and reliability of smartphone~     ophthalmoscopy compared to slit-lamp biomicroscopy in glaucoma screening for potential~     community screening programs.~   "
79935|NCT02520661|"~     The emergency department (ED) is a common source of acute illness care for older adults. Many~     older adults who are discharged home from the ED return within 30 days due to numerous~     challenges faced during the ED-to-home transition. Unless programs to improve the ED-to-home~     transition are identified, the health and financial costs will only increase as the older~     adult population doubles by 2040. This study will apply Coleman's Care Transitions~     Intervention to the ED-to-home transition by adapting the program to account for the unique~     aspects of the ED setting. The research will evaluate the process, ED use, and cost outcomes~     of a community-based, paramedic-coordinated Care Transitions Intervention. Upon completion,~     this study will provide empiric evidence regarding this innovative approach to help the~     rapidly growing older adult population remain healthy and independent after an ED visit.~   "
79936|NCT02520648|"~     The purpose of this trial is to investigate the immediate effects of neuro-lymphatic~     treatment, thoracic vertebral and costal articulatory in terms of back pain levels, cervical~     and dorsal flexibility, sense of body comfort and satisfaction with the treatment received.~   "
79937|NCT02520635|"~     The primary purpose of the study is to evaluate the efficacy and safety of supra-early~     post-surgery chemotherapy versus standard TEMODAL® regimen in treatment of patients with~     newly diagnosed glioblastoma multiforme. The secondary purpose is to assess the efficacy of~     supra-early post-surgery chemotherapy in release brain edema.~   "
79938|NCT02520622|"~     The primary aim is to determine the impact of using digital photographs on a mobile device~     versus printed photographs on skin self-examination rates. The ease-of-use and overall~     satisfaction with the two exam modalities will be evaluated. Secondarily, the impact on~     melanoma thickness at detection, melanoma detection, biopsy, and office visit rates will be~     evaluated. The study involves patients in the Pigmented Lesion Clinic that have received~     total body photography for skin monitoring.~   "
79939|NCT02520609|"~     Background:~      Metabolism refers to the many chemical pathways by which various compounds, including food,~     are processed and used in the body. People with non-alcoholic fatty liver disease (NAFLD)~     have too much fat in their liver cells, but what causes it is unclear. One explanation is~     that people with NAFLD process food and metabolize it differently than people without NAFLD.~     Researchers want to compare how food is metabolized in people with and without NAFLD.~      Objective:~      To better understand how food intake influences the development and progression of NAFLD.~      Eligibility:~      People ages 18 and older with NAFLD or with a non-NAFLD metabolic syndrome~      Healthy volunteers ages 18 and older~      Design:~      Participants will be screened with medical history, surveys, physical exam, and blood tests.~     This will have ultrasound of the abdomen. This uses sound waves to image internal organs.~      Participants will stay at the Clinical Center for 2 nights.~      They will fast he first night.~      On the second day they will:~      Have their metabolism monitored in a metabolism research room for 24 hours~      Have a catheter inserted into an arm vein for several blood tests~      Drink an Ensure Plus for breakfast~      Have solid meals for lunch and dinner~      Have several urine tests.~      The final morning, they will:~      Have more blood tests.~      Have a DXA test to measure the fat in the body. They will lie on their backs for 15-25~     minutes while an x-ray machine is positioned over areas of the body.~   "
79940|NCT02520596|"~     Red raspberries are a rich source of (poly)phenolic compounds, the main components being~     anthocyanins and ellagitannins. There is growing evidence linking consumption of these~     compounds with beneficial effects on human health. However, the mechanisms involved remain~     poorly understood principally because of a limited understanding of the bioavailability of~     ellagitannins and anthocyanins. This study aims to explore the identity and amounts of the~     phenolic metabolites of anthocyanins and ellagitannins in human plasma and urine following~     acute ingestion of raspberries. For this purpose ten healthy volunteers were feed 300 g of~     blended raspberries containing in total 293 μmol anthocyanins and 250 μmol ellagitannins. All~     urine excreted over 48 h after the ingestion of raspberries was collected and blood samples~     were collected before (0 h) and after raspberry consumption up to 24 h. Metabolites were~     identified and quantified by ultra high performance liquid chromatography-mass spectrometry~     (UHPLC-MS).~   "
79941|NCT02520583|"~     To determine the effect of probiotic supplementation on the inflammatory response and~     subsequent performance following a muscle damaging exercise bout, a double-blind, randomized~     placebo controlled two-factor repeated measures design will be employed. The dependent~     variables for this study will include measures of performance as well as markers of~     inflammation in a single limb model. Participants who qualify for study participation will~     have their height, weight, and body composition assessed (skin fold) followed by baseline~     measurements for determination of isometric and dynamic strength. Initial limb will be~     determined randomly. Following baseline testing, participants will randomly be assigned to~     ingest either a probiotic or placebo. Supplementation will begin at least 24 hours post~     baseline testing. Twenty-one days after initiating supplementation, participants will again~     complete performance testing followed by an exercise bout known to elicit muscle damage and~     produce an inflammatory response. Participants will then repeat performance testing 24, 48,~     and 72 hours post muscle damaging bout. Blood samples for determination of markers of~     inflammation will be taken throughout study duration. Following a 3-week wash-out period (21~     days), participants will repeat the experiment following the alternate supplement regimen~     with the contralateral limb.~   "
79942|NCT02520570|"~     1. Investigate the application of ulinastatin(UTI) in real practice clinic.(eg:population~          character, usage and dosage, course of treatment,etc )~        2. Analysis the incidence of adverse drug reactions /adverse events of ulinastatin, collect~          the main clinical manifestations, treatment, outcome, influence factors; provide~          evidence for improving the recommended medication plan of ulinastatin.~        3. Evaluate the safety of ulinastatin , obtain scientific conclusion , and provide evidence~          for appropriate medication to administration department of health authority.~   "
79943|NCT02520557|"~     The purpose of this study is to understand if people with certain genes are predisposed to~     develop severe skin reactions after they are administered Eslicarbazepine Acetate. Currently~     there is no information that suggests that certain individuals who use Eslicarbazepine~     Acetate are predisposed to develop severe skin reactions. However, previous research has~     shown that seizure medicines like carbamazepine (Tegretol®) and oxcarbazepine (Trileptal®,~     Oxtellar XR®) are more likely to cause severe drug related skin reactions in some people of~     Asian ancestry who have specific genes. These are genes found in an area of chromosomes~     called the Major Histocompatibility Complex. This association is called a genetic risk~     factor. The study objective is to compare information that is obtained from individuals with~     a history of seizure disorders who develop severe skin reactions while using Eslicarbazepine~     Acetate to a group of patients who also have a history of seizure disorders and do not have a~     history of a severe skin reaction after using Eslicarbazepine Acetate.~   "
79944|NCT02520544|"~     The aim of this register is to determine the Accolade/Accolade II stem and Trident/Tritanium~     cup survivorship over years.~   "
79945|NCT02520531|"~     Single-centre, prospective, randomized comparative study to compare the maximum flexion and~     Chair Raise achievement ratios of the Scorpio PS and and the Scorpio NRG PS. Documentation of~     all complications.~   "
79946|NCT02520518|"~     Th mechanism of action of dapagliflozin is via sodium-glucose co-transporter 2 (SGLT2)~     inhibition. Sodium-glucose co-transporter 2 inhibition is associated with moderate weight~     (fat) loss, in addition to other health benefits, including decreased blood pressure,~     decreased inflammation, and decreased oxidative stress. It is unclear as to whether these~     health benefits are due to SGLT2 inhibition per se, or as a secondary effect of weight loss.~   "
79947|NCT02520505|"~     This is a prospective randomized control, crossover trial to determine if supraovulation with~     clomiphene citrate and intrauterine insemination is more efficacious than expectant~     management in women with stage III or IV endometriosis who have recently undergone operative~     laparoscopy.~   "
79948|NCT02520492|"~     In patients at risk of increased intracranial pressure (ICP), ICP measurements require~     invasive transducers, usually with insertion of a catheter into the cranium, or through a~     spinal tap. These invasive modalities involve risks and pain and they can be done only in~     specialized care units, with a high associated cost.~      A novel method for detecting changes in ICP has developed recently. The auditory hair cells~     emit sounds and electric signals in response to sound, which can be easily detected and~     measured non-invasively with the help of a microphone probe placed in the external ear canal~     or regular electrodes. Indeed, the cochlear aqueduct connects the cerebrospinal fluid (CSF)~     spaces to the inner ear in such a way that ICP and inner-ear fluid pressure equalize within~     seconds.~      A symptom of intracranial pressure (ICP) was observed in glioma patient due to a combination~     of causes: the inflammatory reaction around the tumor, the mass effect of the tumor,~     secondary vascular changes, a change in the flow of CSF.~      The evaluation of intracranial hypertension by increased ICP (invasive) is not used in the~     monitoring of intracranial tumors. It is then detected by using routine clinical signs, in~     combination with a standard imaging method (MRI), but still subjective.~      The measurement of noninvasive ICP could allow earlier detection of relapse, and evaluate~     whether the increase in ICP precedes tumor clinical worsening and / or imaging.~   "
79949|NCT02520479|"~     A phase 2 study was conducted of sandwich protocols, with earlier RT after an initial 2 of~     P-CHOP (Pegaspargase, cyclophosphamide,vincristine, doxorubicin and dexamethasone ), followed~     by further two consolidation cycles,to explore the appropriate mode of combined modality~     therapy (CMT) in early stage ENKTL.~   "
79950|NCT02520466|"~     The aim of the present study is to investigate whether the ingestion of a cocoa~     flavanol-containing drink compared to a flavanol-free drink, improves coronary vasomotion and~     platelet function in patients with overt coronary artery disease acutely (after 2 hours)~   "
79951|NCT02520453|"~     Adjuvant Durvalumab vs Placebo for 1 year after complete resection of esophageal cancer~     following neoadjuvant CCRT.~   "
79952|NCT02520440|"~     The gastrointestinal dysfunction occurs frequently during the intensive care unit (ICU) stay~     and is associated with a worse prognosis.~      The gastrointestinal failure (GIF) is diagnosed based on symptoms such as bowel distension,~     ileus, diarrhea, digestive bleeding, or intestinal ischemia. A GIF score based on has been~     demonstrated to be correlated with outcome, with higher scores indicating higher risk of~     death. However, GIF may be occult or clinical signs can go undetected in critically ill~     patients due to the frequent use of analgesic, sedative or neuromuscular blocking agents,~     acute neurologic diseases, or delirium.~      Citrulline is a potential biomarker for small bowel function in critically ill patients with~     maintained renal function. Normal plasma citrulline levels (12-55 µmol/L) are determined by~     the balance between gut synthesis and kidney degradation.~      GIF is involved in the pathogenesis of multiple organ dysfunctions and failures (MOF) through~     various mechanisms, and it is often associated with high intra-abdominal pressure (IAP). IAP~     greater than 12 mmHg, may lead to abdominal compartment syndrome (ACS) and MOF, including~     cardiac, respiratory and kidney failure. Studies have suggested that GIF can be the~     consequence rather than the cause of MOF.~      The aim of this study is to investigate if plasma citrulline levels is associated with a~     clinical diagnosis of GIF, and may predict the development of MOF.~   "
79953|NCT02520427|"~     The purpose of this First-in-Human Phase 1 study is to determine if AMG 330 given as a~     continuous IV infusion is safe and tolerable in adult subjects that have relapsed/refractory~     Acute Myeloid Leukemia, and to determine the maximum tolerated dose and/or a biologically~     active dose. The study will be conducted in multiple sites and test increasing doses of AMG~     330. The safety of subjects will be monitored by intensive assessment of vital signs,~     electrocardiograms, physical examinations, and laboratory tests.~   "
79954|NCT02520414|"~     The purpose of this study is to determine the safety and feasibility of using the Symphion~     system in an office setting.~   "
79955|NCT02520401|"~     This studies aims to investigate the effect of a probiotics in peri-implantitis patients as~     an adjunct to non-surgical therapy.~   "
79956|NCT02520388|"~     This Phase 3 pivotal efficacy trial will examine the effects of HLD200 (methylphenidate) in~     patients aged 6-12 years with ADHD in a naturalistic setting. Following a screening/washout~     period (Visit 1), subjects will randomized to double-blind placebo or HLD200 for a period of~     3 weeks (Visits 2-5) before assessing clinical study endpoints at last study visit.~   "
79957|NCT02520375|"~     The aim of this study is to determine the impact of a prebiotic toothpaste and mouthrinse in~     periodontitis patients as an adjunct to scaling and rootplaning.~   "
79958|NCT02520362|"~     This is a prospective open cohort study with annual assessment and reporting of descriptive~     findings and a final report at the end of the study to address all study objectives. The~     study period will include 10 years of data accumulated in each data system. The study start~     date is the denosumab international birth date, 26 May 2010. The data end date will be 10~     years after the international birth date, 25 May 2020.The primary data sources will be the~     following:• US Medicare, including Parts A, B, and D• United HealthCare• Scandinavian~     national health registry databases, including data from Denmark, Sweden, and Norway. Data~     will be collected for postmenopausal women overall, women with Postmenopausal Osteoporosis,~     and patients who receive Prolia for unapproved indications. Among women with Postmenopausal~     Osteoporosis, exposure cohorts will be established based on exposure to denosumab or~     bisphosphonates. Nine adverse events of special interest will be identified using validated~     algorithms based on inpatient and outpatient diagnosis and procedure codes, and, for some~     AESI, medication codes or laboratory data. Selected AESI (osteonecoris of the jaw and~     atypical femoral fracture) will be confirmed by medical chart review.~   "
79959|NCT02520349|"~     The proposed research is a longitudinal human lab study to examine how measures of abuse~     liability and product appeal vary by e-cigarette device type, and how these lab assessments~     may predict subsequent e-cigarette and other tobacco use behavior at 1,3, and 6 months. An~     additional aim is to evaluate e-cigarette safety and tolerability among smokers by device~     type.~   "
79960|NCT02520336|"~     Assess postpartum diabetes screening in GDM patients with initiation of a reminder system in~     the postpartum period~   "
79961|NCT02520323|"~     The objective of this study is to determine the presence of bacterial species, and the~     immunologic and molecular mechanisms of granuloma formation that might be involved in the~     pathogenesis of sarcoidosis. The investigators will collect peripheral blood and~     bronchoalveolar lavage fluid samples to isolate bacterial DNA and blood monocytes and~     lymphocytes. Specimens will be obtained from patients with sarcoidosis, with non-sarcoid lung~     disease, and healthy volunteers to directly compare the bacterial species present and the~     characteristics of cells thought to be involved in granuloma formation.~   "
79962|NCT02520310|"~     The objective of the study is to confirm the reproducibility of the evidence of safety and~     efficacy of AVJ-514 System technology in Japanese subjects who have been deemed difficult for~     mitral valve surgery by the local site heart team.~   "
79963|NCT02520297|"~     The primary objective is to evaluate the analgesic efficacy of TRV130 for moderate to severe~     acute pain in patients presenting to the emergency department (ED) with a suspected/known,~     unilateral, closed long bone fracture.~   "
79964|NCT02520284|"~     This study will evaluate the efficacy, safety, and tolerability of GS-5745. It will consist~     of 3 parts: Induction Study (Cohort 1), and Maintenance Study (Cohort 2), and an Extended~     Treatment Phase.~   "
79965|NCT02520271|"~     Ostrobothnia Depression Study (ODS) was conducted in the South Ostrobothnia hospital district~     of Finland during 2009-2014. ODS is a naturalistic, open label, non-randomized follow-up~     study on depression and related substance use disorders (SUD). The study focuses on several~     aspects concerning the relation of depression and SUDs, the efficacy of selected assessment~     and treatment protocols, characteristics and genetics of the participants and the use of~     related biomarkers in clinical practice. The misused substance in focus is alcohol. In this~     study, dual diagnosis (DD) is defined as the simultaneous presence of clinically diagnosed~     major depressive disorder (MDD) and alcohol use disorder (AUD). The study was approved by the~     local ethics committee. Written informed consent was collected from all participants.~   "
79966|NCT02520258|"~     Experiments have shown that some artificial sweeteners like those in diet soda can cause~     changes in how the body responds to and uses sugar. These changes increase the chance of~     obesity, type 2 diabetes, and other metabolic diseases. In this study, the investigators plan~     to see if the most common artificial sweetener, aspartame (brand name Equal, NutraSweet),~     causes these changes. The investigators believe that if metabolic changes are observed in a~     person who consumes aspartame, then removing all aspartame from the diet might lead to a~     reversal of the changes and a normalization of test results.This would impact sweetener~     additives in our foods and thus decrease the incidence of obesity, diabetes, and the~     metabolic syndrome.~   "
79967|NCT02520245|"~     This study has been designed to collect long-term follow-up information for patients who~     received REGN2810 in other clinical studies and to allow re-treatment for eligible patients.~   "
79968|NCT02520232|"~     Alzheimer's disease (AD) is an irreversible, progressive brain disease. It is the most common~     form of dementia and the major cause of functional dependence in the elderly. Since there is~     currently no cure for Alzheimer's disease, a growing number of scientists pointed out the~     interest to use non-pharmacological alternative therapeutic approaches in order to slow down~     the decline of physical and cognitive resources and improve quality of life of patients with~     Alzheimer's disease. Several narrative and meta-analytical reviews suggest that regular~     practice of physical activity delays the occurrence of cognitive decline and slows down~     Alzheimer's disease progress when compared with sedentary people. Despite the growing~     interest of the scientific community for the positive effects of chronic exercise on mental~     health and cognitive functions, the clinical reality of this phenomenon remains to be clearly~     established, more particularly in aged people suffering from neurodegenerative diseases.The~     first aim of this research project is to test if chronic exercise reduces and even~     compensates for a cognitive decline in both patients with prodromal Alzheimer's disease~     (i.e., no dementia) and aging people with no pathology of central nervous system. The second~     aim of this research project is to examine whether an increasing of cerebral blood flow~     induced by chronic exercise can explain this positive effect.~   "
79969|NCT02520219|"~     The aim of this study is to evaluate anti-tumor safety and efficacy of endostar®（Human~     recombinant endostatin injection）combined with traditional GDP~     （gemcitabine+dexamethasone+cis-platinum）chemotherapy for newly diagnosed or relapsed~     PTCL(aggressive peripheral T-cell lymphomas) patients in phase II clinical study.~   "
79970|NCT02520206|"~     The investigators propose to conduct a translational study on the regulation of~     S-adenosylmethionine synthesis and cellular methylation reactions during chronic~     inflammation. Development of in vitro cell models may reveal the regulatory mechanisms by~     which specific inflammatory mediators cause metabolic changes and alter DNA methylation~     status. Metabolic and pharmacological studies in the in vivo models will enable us to better~     understand the regulation of inter-organ homeostasis of S-adenosyl methionine and help~     identify tissue specific biomarkers for methylation and epigenetic modifications in different~     stage of chronic inflammation. The clinical study in human subjects will help distinguish the~     impacts of autoimmune rheumatic disease, degenerated joint disease, or specific medication~     use on significant clinical and biochemical markers in folate and vitamin B6 metabolic~     pathways.The Investigators hope the present study can identify specific clinical markers for~     potential epigenetic changes in patients suffering from chronic inflammation, which will~     contribute to better clinical management of these diseases in humans.~   "
80020|NCT02519543|"~     In a previous study by Dr. Calkin, the principal investigator of this study, persons with~     bipolar disorder and either type II diabetes or insulin resistance were found to experience~     more severe symptoms of bipolar illness and a lower response to treatment, compared to~     persons with bipolar disorder who did not have type II diabetes or insulin resistance. To~     further explore these findings, the investigators have developed this study to see if adding~     metformin, a drug used to improve the body's use of insulin, may also help improve the~     symptoms of bipolar illness.~   "
79971|NCT02520193|"~     The purpose of the present study is to compare usual care in terms of mobilization performed~     to intubated ICU patients to a standardized program designed to deliver early mobilization at~     least 5 days a week.~      This study has a before / after design with a control group during the experimental phase.~     The first phase of the study corresponds to an observational phase during which every act of~     mobilization performed to the included patients is going to be documented. During this first~     study period, total duration of mechanical ventilation is going to be recorded for all the~     patients included.~      At the end of this first study period, the participating ICU are going to be randomized~     (Cluster randomization) in two groups either observational or experimental. The corresponding~     strategy is going to be applied to all the patients included during the second study period.~     During this second period, total duration of mechanical ventilation is also going to be~     recorded for all the patients included.~      The study hypothesis is that applying a protocolized early mobilization strategy increases~     the number of ventilator free-days during the 28 days after intubation in ICU patients.~   "
79972|NCT02520180|"~     Purpose The TARGET All comers trial is a prospective, multicenter, randomized, two-arm,~     non-inferiority, open-label study with 1656 patients at 20 centers in Europe. The study is a~     real world, all comers study.~   "
79973|NCT02520167|"~     This study will pilot and assess feasibility of a prenatal intervention for obese pregnant~     women based on the Diabetes Prevention Program (DPP). Intervention group participants will~     meet with a clinic dietitian for 15 minutes at every prenatal appointment to complete a~     DPP-based curriculum and receive breastfeeding education. Control group participants will~     receive usual prenatal care. Outcomes include reach and dose of the intervention, gestational~     weight gain, dietary intake, physical activity, and breastfeeding in the first 6 weeks~     postpartum.~   "
79974|NCT02520154|"~     The goal of this clinical research study is to learn about the safety of giving the~     combination of pembrolizumab, carboplatin, and paclitaxel to patients with high-grade~     epithelial non-mucinous ovarian, primary peritoneal, or Fallopian tube cancer. Researchers~     want to find out how the disease responds to therapy with pembrolizumab.~      This is an investigational study. Pembrolizumab is FDA-approved and commercially available~     for the treatment of certain types of melanoma. Its use in patients with ovarian cancer is~     investigational. Carboplatin and paclitaxel are both FDA-approved and commercially available~     for the treatment of advanced ovarian cancer. The study doctor can explain how the study drug~     combination is designed to work.~      Up to 30 participants will be enrolled in this study. All will take part at MD Anderson.~   "
79975|NCT02520141|"~     The goal of this clinical research study is to learn if ramucirumab can help to control~     biliary cancer. The safety of this drug will also be studied.~   "
79976|NCT02520128|"~     IMRiS is a phase II trial which aims to assess the feasibility, efficacy and toxicity of~     Intensity Modulated Radiotherapy (IMRT) in three different cohorts of patients with primary~     bone and soft tissue sarcoma and to demonstrate whether IMRT can improve on current clinical~     outcomes.~      Cohort 1 of the trial is now closed to recruitment.~   "
79977|NCT02520115|"~     This pilot research trial studies folate receptor in diagnosing ovarian cancer using serum~     samples from patients with a newly diagnosed pelvic mass or previously diagnosed ovarian~     cancer. Studying samples of serum from patients with ovarian cancer in the laboratory may~     help understand the use of folate receptor induction as a clinical tool in initial diagnosis,~     surveillance, and recurrence.~   "
79978|NCT02520102|"~     Primary Objective:~      Measure the proportion of patients who develop binding and neutralizing antibodies in the~     blood after treatment with sargramostim following induction/reinduction chemotherapy.~      Secondary Objectives:~        -  Assess the time after treatment at which the antibodies develop and the level of~          antibodies is measured after the first dose.~        -  Measure the levels of immunoglobulin protein.~        -  Assess the impact of any immune response on safety and the duration of low white blood~          cell count.~   "
79979|NCT02520089|"~     Patients with humeral shaft pseudoarthrosis is going to be treated with a standard protocol~     with a locking compression plate and bone autograft, and other group of patients treated with~     platelet rich plasma.~      Posteriorly all the patients it will evaluated radiographically and with functional scales~     for a period of one year.~   "
79980|NCT02520076|"~     Islet transplantation is a relatively new procedure used in people with difficult to control~     Type 1 diabetes. Insulin producing cells (islets) are isolated from a pancreas donated by the~     next of kin of a person who is brain dead. After the cells are prepared, the islets are~     transplanted into the recipient's liver and produce insulin. Patients who receive an islet~     transplant take medication that suppresses their immune system and prevent rejection of the~     islet tissue.~      The investigators have also learned that there is general inflammation at the time of the~     transplant that is not fully controlled with our standard medications. The investigators~     believe this inflammation may cause some islet cell death around the time of transplant. Due~     to this islet death around the time of transplant, most recipients need 2 or 3 separate~     transplant procedures.~      The investigators are studying the use of Alpha-1 Antitrypsin (AAT) in islet transplant to~     decrease the amount of cell death caused by general inflammation. In this study, the~     investigators hope to decrease the need for more than one transplant procedure by controlling~     inflammation, before and after transplant, with Alpha-1 Antitrypsin (Aralast NP).~      Alpha-1 Antitrypsin is a protein made in healthy humans that helps to prevent tissue damage~     during times of inflammation. Alpha-1 Antitrypsin is obtained from healthy plasma donors.~     There have been studies in Islet Transplant in monkeys using this medication and it has shown~     to protect the islets from inflammation.~      This study involves using Alpha-1 Antitrypsin in addition to our current Standard of Care~     medications used in Islet Transplant.~   "
79981|NCT02520063|"~     This study will test how well a new combination of three drugs (Letrozole, Everolimus, and~     TRC105) is tolerated and how well it works in Stage 2 and 3 breast cancer when given prior to~     definitive surgery. Letrozole blocks the estrogen receptor expressed by many breast cancers~     while everolimus blocks signals that drive cancer cells to grow. TRC105 is an investigational~     drug that blocks the formation and growth of blood vessels that feed the cancer and promote~     its growth. The goal of this study is to investigate the safety and efficacy of this~     multitargeted approach in breast cancer.~   "
79982|NCT02520050|"~     The American Diabetes Association (ADA), among other medical societies, is strongly~     recommending medical nutrition therapy (MNT) for prevention and management of type 2~     diabetes. However, the ADA recognized that there is no one size fits all diet and thus~     recommends that MNT should be conducted through a consultation with registered dietitians~     (RD). Previous studies have shown that using diabetes-specific nutritional formulas, as an~     integral part of the MNT, lowers postprandial blood glucose levels. Through our experience~     from the Joslin's Weight Achievement and Intensive Treatment (Why WAIT™) program, applying~     MNT within a structured dietary intervention protocol has the best impact on blood glucose~     values and body weight. Meanwhile, the frequent use of health coaching during dietary~     intervention proved to be effective in managing diabetes and inducing weight loss. However,~     no study compared those three intervention methods in a randomized clinical study.~      The aim of this study is to evaluate the effect of different models of conducting medical~     nutrition therapy on the glycemic control in patients with type 2 diabetes.~   "
79983|NCT02520037|"~     Fluids are generally administered to patients in order to improve circulation. However,~     fluids do not always improve circulation and fluids have side effects. Unfortunately, it is~     difficult to predict whether fluid administration improves the circulation, i.e. it is~     difficult to predict fluid responsiveness The overall aim of this observational study is to~     investigate if analysis of spontaneously occuring extra systoles can give the answer: The~     second beat in the extra systole - the post ectopic beat - is a normal sinus beat but it has~     experienced the compensatory pause, i.e. this beat is associated with increased filling time~     and in turn associated with increased filling. As such, the post ectopic beat shows how the~     heart responds to increased filling. Therefore, the hypothesis of this study is that the~     hemodynamic response to the increased filling at the post ectopic beat (compared with sinus~     beats) can predict fluid responsiveness~   "
79984|NCT02520024|"~     This project proposed to demonstrate the effectiveness, costs, and benefits to participation~     and community living self-directed care programming within a financially sustainable Medicaid~     managed care environment. The study examined outcomes associated with the implementation of a~     novel self-directed care (SDC) approach being implemented in Delaware County, Pennsylvania in~     which consumers were able to access a set amount of renewable funds per year and direct how~     they were spent, both to purchase the types and amounts of rehabilitation and treatment~     services they desire (and from whom they choose) and to purchase a broad-range of~     individualized resources and services that are generally outside of Medicaid funding (e.g.,~     health club memberships, yoga classes, support in taking care of bills).~   "
79985|NCT02520011|"~     The purpose of this two-stage Phase 2 study is to assess the clinical response (Complete~     Remission) to FLAM compared to AM treatment in refractory or relapsed AML patients with~     demonstrated NOXA BH3 priming of ≥ 40% by mitochondrial profiling in bone marrow.~   "
79986|NCT02519998|"~     The purpose of this study is to prospectively collect a comprehensive, multi-modality set of~     diagnostics on patients who have had a concussion, repeating some of these tests serially~     over time, so that the investigators may then in the future perform retrospective data mining~     to determine if there were a biomarker or risk calculator that could be used to guide~     return-to-play and other medical decisions.~   "
79987|NCT02519985|"~     The purpose of this study is to evaluate the repeatability and reproducibility of corneal~     (including corneal, epithelial, stromal, and LASIK flap thickness) and anterior segment~     measurements using the ArcScan Insight 100 very high-frequency digital ultrasound~     arc-scanner.~   "
79988|NCT02519972|"~     Screening with the use of low-dose computed tomography (LDCT) reduces mortality from lung~     cancer. Relatives with family history of lung cancer are at increased risk of lung cancer~     compared to those without a family history in pooled analysis. A prospective trial using LDCT~     of lung to screen the relatives with family history of lung cancer is needed.~   "
79989|NCT02519946|"~     Pediatric heart transplant patients have a high-risk cardiovascular profile affecting their~     long-term outcomes and survival. Currently, no effective cardiovascular preventative care is~     provided for this pediatric population, in part, due to the fact that clinic-based programs~     are not easily accessible to children and their families. However, tele-health has been show~     to improve medical outcomes by making care more accessible to these patients. This study aims~     to meet the urgent need for an effective and sustainable delivery of preventative care to~     pediatric heart transplant patients using a diet and exercise intervention program delivered~     live over the internet direct to these patients' homes.~   "
79990|NCT02519933|"~     A well-functioning vascular access is essential for effective hemodialysis. The native~     arteriovenous fistula (AVF) is the preferred vascular access because of the lower thrombosis~     and infection risks compared to either synthetic arteriovenous grafts or central venous~     catheters. Brachiocephalic arteriovenous fistula (BCAVF) and transposed brachiobasilic~     arteriovenous fistula (T-BBAVF) are recommended when there is either a primary failure or no~     suitable vessels for the forearm fistula. However, BCAVF is frequently cannulated at the~     antecubital fossa, the risks of stenosis and thrombosis are high, which will compromise~     proper BCAVF function and survival. T-BBAVF is not only technically challenging, but also~     associates with severe arm swelling and pain. Thus, the investigators introduced a novel~     modified Non-transposed brachiobasilic arteriovenous fistula (mNT-BBAVF) for long-term~     hemodialysis patients. To confirm its efficacy, a prospective clinical study would be carried~     out.~   "
79991|NCT02519920|"~     This study was to test an appropriate dose of fluorescein sodium which can provide high image~     quality to ensure endoscopy examination and have no yellow dye in the skin by a randomized~     blinded controlled trial.~   "
80021|NCT02519530|"~     Investigators are carrying out a study to assess the immediate and long-term effects of a~     positive youth development program (the Teen Outreach Program) on high school youth in~     Florida. This study will answer the following questions: What is the impact of the Teen~     Outreach Program on sexual activity and positive youth development at the end of the program~     and 10 months after the program?~   "
80117|NCT02518269|"~     The study is designed to compare three articulation options in terms of osteolysis, patient~     satisfaction, clinical and radiographic outcomes (Oxford Hip score (OHS) and Harris Hip score~     (HHS)) and safety.~      In addition, the purpose of the study is also to evaluate the safety and effectiveness of~     patients who received G7 Acetabular system in conjunction with Echo BiMetric stem in primary~     total hip arthroplasty.~   "
79992|NCT02519907|"~     Phantom limb pain (PLP) is a frequent consequence of amputation, and it is notoriously~     difficult to treat. Amputation usually follows traumatic injuries or surgery following~     vascular diseases, diabetes, osteomyelitis or tumours in cases where the loss of the limb is~     required for the survival of the patient. The loss of a limb or other body parts is usually~     followed by the sensation that the lost body part is still present and can be felt. These~     phenomena are called, respectively, phantom awareness and phantom sensation. In 50-80% of~     amputees neuropathic pain develops in the lost limb also referred to as phantom limb pain~     (PLP). PLP can be related to a certain position or movement of the phantom limb, and might be~     elicited or worsened by a range of physical factors (e.g. changes in the weather or pressure~     on the residual limb) and psychological factors (e.g. emotional stress). It is well known~     that most treatments available for PLP today, such as pharmacological, surgical, anaesthetic,~     psychological and other, are ineffective.~      Today it is believed that phantom limb pain may be related to changes in the cortex of the~     brain. There is evidence that these changes may be modulated - or even reversed - by~     providing sensory input to the stump or amputation zone. For example, cortical reorganization~     and alleviation of phantom limb pain has been observed in amputees following intense use of a~     hand prosthesis. However, there is no consistent knowledge on which type of peripheral~     sensory feedback may be effective in affecting the cortical plasticity or on how to best~     apply the sensory feedback.~      The aim of the proposed research is to create natural, meaningful sensations through~     providing non-invasive sensory feedback (i.e. surface electrical stimulation) and the~     effectiveness to alleviate phantom limb pain and restore the cortical neuroplastic changes.~   "
79993|NCT02519894|"~     Introduction :~      Due to Chronic kidney disease is a public health problem, which is important increased in~     both developed and developing countries . And sodium intake restriction was related to the~     reduction of blood pressure and urine protein which is one of the important risk factor in~     chronic kidney disease. One of the problem in sodium restriction failure in Thai population~     with CKD nowadays is lack of knowledge and problem unawareness.~      The study hypothesis :~      Intense knowledge about sodium reduction and immediate feedback of the sodium intake could be~     simultaneously modifying the behavior to reduce sodium intake , blood pressure and also GFR~     reduction rate~      Objectives :~      To compare the effect of dietary salt restriction on glomerular filtration rate (GFR) between~     CKD patients receiving strict controlled combined with immediate individual feedback (DISC~     Progrram) and those receiving standard education.~      Study design :~      Multicenter, open labeled, parallel, randomized controlled trial~      Sample size : 600~      Primary outcome : GFR reduction (CKD-EPI)~      Secondary outcome :~        -  Achievement rate of Na intake < 2 g/day (Urine Na < 90 mEq/day)~        -  Blood pressure difference~        -  Proportions of patients with BP reached the target (130/80 mmHg)~        -  Number of anti-hypertensive drugs use to achieve BP target~        -  Urine albumin/creatinine ratio~        -  Major Adverse Cardiac Events (MACE)~        -  Cardio-ankle vascular index (CAVI)~        -  ankle-brachial index (ABI)~      Documentary Proof of Ethical Clearance :~      This project has been reviewed and approved by the Comittee on Human Rights Related to~     Research Involving Human Subjects , based on the declaration of Helsinki~   "
79994|NCT02519881|"~     This study was designed to evaluate the efficacy and safety of a modified microfracture using~     collagen, and to compare them with those of a simple microfracture in patients with cartilage~     defects in their ankles.~   "
79995|NCT02519868|"~     High blood pressure, also referred to as hypertension, affects about 65 million people in the~     United States alone. Approximately 25 percent of people with hypertension cannot control~     their high blood pressure, despite the use of multiple medications. Recently, new evidence~     has demonstrated that the carotid body (CB) plays a role in essential refractory~     hypertension, possibly due to a deregulated, enhanced activity of this organ. Animal studies~     showed that CB de-afferentiation, through carotid sinus nerve denervation, leads to a~     long-term stable drop in blood pressure in spontaneously hypertensive rats. De-afferentiation~     may be performed either by injecting local anesthetics or by electrical stimulation. Both~     techniques are daily used in the operating theater to anesthetize nerves for a wide range of~     surgical procedures. We hypothesize that blocking CB with local anesthetics will result in a~     drop of the blood pressure in refractory hypertensive patients. We also want to test the idea~     that stimulating the CB with an electrical current will mislead the CB and will also result~     in a drop of the blood pressure.~   "
79996|NCT02519855|"~     The study evaluated immunogenicity, safety, and tolerability of ZOSTAVAX™ Vaccine (V211)~     administered concomitantly versus nonconcomitantly with Quadrivalent Influenza Virus vaccine~     (inactivated) in participants ≥50 years of age. The primary hypotheses tested 1) the~     noninferiority of concomitant versus nonconcomitant vaccination with regard to Varicella~     zoster virus (VZV) Geometric Mean Titer (GMT) antibody responses, 2) the acceptability of~     geometric mean fold rise in VZV antibody response after concomitant vaccination, and 3) the~     noninferiority of concomitant versus nonconcomitant vaccination with regard to influenza~     virus strain-specific GMT antibody responses.~   "
79997|NCT02519842|"~     The purpose of this study is to evaluate the efficacy and safety of fosaprepitant (MK-0517)~     plus ondansetron versus ondansetron alone for the prevention of chemotherapy-induced nausea~     and vomiting (CINV) in pediatric participants scheduled to receive chemotherapeutic agent(s)~     associated with moderate or high risk of causing emesis (vomiting), or chemotherapy agent(s)~     not previously tolerated due to vomiting. The primary hypothesis is that a single dose of~     fosaprepitant in combination with ondansetron provides superior control of CINV compared to~     ondansetron alone as measured by the percentage of participants with a Complete Response (no~     vomiting, no retching, and no use of rescue medications) in the delayed phase (>24 to 120~     hours) following initiation of emetogneic chemotherapy in Cycle 1.~   "
79998|NCT02519829|"~     Patients undergoing primary hip arthroplasty will be randomized to receive either monocryl~     closure of fascial and dermal layers with dermabond and tegaderm covering versus standard~     vicryl closure of fascia layer and staple closure for skin. Short term wound complications,~     pain and patient and surgeon-rated cosmetic scar appearance will be measured. The~     investigators will also measure operating room time and costs associated with dressing~     changes and wound-related procedures (e.g. staple removal).~   "
79999|NCT02519816|"~     Phase II multicenter, Canadian only study - open to 25 subjects. Study open to subjects with~     steroid-refractory or dependent chronic graft vs host disease.~      Series of 6 aphereses and 28 re-infusions over 24 weeks. Primary endpoint is FFS at 24 weeks.~     Primary objective is to measure the efficacy of CARE (Continuous Alloreactive T-Cell~     depletion and Regulatory T-cell Expansion)~   "
80144|NCT02517918|"~     This is a prospective open-labeled phase I trial based on a dose escalating study design~     assessing two dose levels of sirolimus when prescribed in combination with metronomic~     cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) followed by an expansion~     cohort once the Maximum Tolerated Dose (MTD) is established.~   "
80000|NCT02519803|"~     Title: A Prospective Household observational cohort study of Influenza, Respiratory Syncytial~     virus and other respiratory pathogens community burden and Transmission dynamics in South~     Africa (The PHIRST Study) This study will improve understanding of the community burden of~     influenza, RSV, pertussis, tuberculosis and pneumococcal infection in South Africa. It will~     also provide data on the carriage prevalence of meningococcus and diphtheria. The data~     generated from this study will also provide important information on the transmission~     dynamics of influenza, RSV, pertussis and pneumococcus in the community allowing to better~     strategize interventions (including targeted vaccination strategies) and evaluate their~     potential impact. Moreover, there is an absence of prospective data on tuberculosis infection~     from high tuberculosis burden countries. The data generated will both inform modelling of~     transmission, sample size for prevention studies and surveillance assessing the impact of the~     National Tuberculosis Control Program.~   "
80001|NCT02519790|"~     The purpose of this study is to explore the way the antidepressant concentration (amount of~     medication) in the blood changes due to the physiological changes in the body (i.e., changes~     in metabolism, hormones and body fluid) during pregnancy and postpartum and the impact of~     genetic factors on the degree of these changes. Changes in antidepressant concentration are~     important to monitor, as decreases in antidepressant concentration may lead to less than~     therapeutic drug levels, which may cause an increase in mood symptoms or recurrence of~     depressive episodes. Increases in antidepressant concentration have the potential to lead to~     increased side effects. The study team is hoping to better understand the course of these~     changes across pregnancy and postpartum and how an individual's genetic makeup impacts these~     changes with the goal of developing guidelines to optimize antidepressant treatment of~     pregnant women.~   "
80002|NCT02519777|"~     People infected with HIV often have cognitive dysfunction even if they are on antiretroviral~     therapy (ART) and have undetectable viral loads. The purpose of this study is to evaluate if~     the addition of maraviroc (MVC) and dolutegravir (DTG) (which are two antiretroviral [ARV]~     medications) to participants' existing ART regimens will improve participants' neurocognitive~     performance.~   "
80003|NCT02519764|"~     The main objective of this study is to evaluate the impact of a hydration protocol at~     thirst compared to other not at thirst hydration protocols on the changes in serum sodium~     in runners of the Ultra Trail Mont-Blanc (UTMB) in 2015.~   "
80004|NCT02519751|"~     Creatine (methyl-d3) dilution (D3-creatine) is a novel technique for the estimation of muscle~     mass. The method uses a dose of deuterium-labelled creatine to determine total skeletal~     muscle mass via estimation of total body creatine pool size.The aim of this study is to~     compare estimates of total body skeletal muscle mass by D3-creatine dilution method and whole~     body Magnetic Resonance Imaging (MRI) in an athletic population.~   "
80005|NCT02519738|"~     Granulation tissue, or excess tissue, forms around gastrostomy tube sites and is a common~     problem seen in the pediatric surgery population. There is no standard treatment that has~     been identified in clinical practice to treat granulation tissue effectively. Clinicians~     prescribe treatments of varying nature to help treat this condition. By conducting this~     study, the investigators hope to identify if there is any difference in the treatment groups~     and if there is any superiority for one treatment over the other. The three arms in the study~     are Silver Nitrate treatment, treatment with Kenalog, and Washcloth abrasion. Treatments will~     continue over a period of three weeks, and the progress will be followed using surveys and~     photographs.~   "
80006|NCT02519725|"~     The purpose of this study is to assess the influence of an ICU diary implemented during the~     ICU stay on the psychological well-being of patients and families after ICU discharge.~   "
80007|NCT02519712|"~     The purpose of this study is to test a method of bone marrow transplantation that results in~     only temporary donor immune function. In other words, the donor immune cells are given in a~     way that will allow them to attack leukemia briefly before being destroyed by their own~     immune system, or rejected. The investigators want to test whether temporary donor immune~     function is enough to improve the odds of achieving a remission without exposing the patient~     to the toxicities of a full bone marrow transplant. To do this, the investigators will use~     standard chemotherapy for AML followed by an infusion of donor stem cells. The donor will be~     a family member who is haploidentically, or half matched, to the patient such as a child or~     sibling. Chemotherapy designed to treat AML should not be strong enough to prevent them from~     rejecting the donor stem cells. The investigators will then follow the patient to see how~     long the donor stem cells stay in them. The study will test whether this process is feasible~     and can result in improved chances of obtaining a remission.~   "
80008|NCT02519699|"~     The optimal levels of mean arterial pressure that must be achieved in septic shock are~     subject of debate. Studies tried to correlate blood pressure increase in patients with septic~     shock with microcirculation. However, there are few studies that specifically assessed septic~     shock patients with previous arterial hypertension. The main objective of this study is to~     evaluate the effect of increased blood pressure level in the microcirculation of these~     patients and compare them with patients without arterial hypertension.~   "
80009|NCT02519686|"~     The purpose of this study is to determine if the trendelenberg (TD) position (position in~     procedures that involves placing the patient at an angle so that their head is lower than~     their feet on the procedure bed) in select patients undergoing colonoscopy is superior than~     the left lateral (LL) position (patient laying on their side, traditionally used for~     colonoscopies) in terms of decreasing time necessary to pass the colonoscope through the left~     colon, and decreasing the difficulty of the procedure.~   "
80019|NCT02519556|"~     Atopic dermatitis (AD) is an immune disorder, characterized by chronic skin inflammation or~     relapsing, whose prevalence is increasing worldwide. Its exact etiology remains unknown. The~     hypothesis that an appropriate early stimulation of the intestinal flora contributes to the~     establishment of the immune system balance has led to the use of probiotics in the prevention~     and treatment of AD in several clinical and experimental studies.~      Therefore, the objectives of this study will evaluate the clinical efficacy of the mixture of~     probiotics (Lactobacillus and Bifidobacterium) in children with AD through the SCORAD~     (scoring atopic dermatitis) and to evaluate the effects of this medication in the following~     laboratory parameters: skin prick test, total serum immunoglobulin E (IgE), inflammation~     composite (interferon gamma [ɣ - IFN], interleukins [IL1-β, IL-4, IL-6, IL-8] and tumor~     necrosis factor alpha) and immune tolerance composite (IL-10, IL-17 and transforming growth~     factor beta [TGF - β]).~   "
80010|NCT02519673|"~     In refractive surgery, stromal ablation depth is fundamental because it determines the~     thickness of the residual posterior wall. The posterior wall is an essential element that~     guarantees the refractive stability and the long term prevention of corneal ectasia after~     corneal refractive surgery. A minimum thickness of more or less 300 microns is universally~     accepted. Its calculation is based on well-known formulas, such as Munnerlynn ones.~      With the excimer laser platform last generation WaveLight® Allegretto® EX-500 of Alcon, a new~     treatment option called wavefront optimized is offered for myopia, astigmatism and~     hyperopia. The ablation profile has been developed to save stromal tissue consumption and to~     favor the quality of vision, by optimizing connections between the optical zone and the~     transition zone of the photoablation. Alongside the theoretical formulas, evaluation of the~     depth of ablation may be defined by differential ultrasonic pachymetry or by topographical~     analysis pre and postoperatively. The latter is currently the method of reference to assess~     the corneal thickness.~   "
80011|NCT02519660|"~     Needle-related procedures are among the most common sources of pain and distress for children~     in the health care setting. More than 50% of children reported pain during these procedures.~     The necessity for pain management during these procedures is well established. Topical~     anesthesia has been shown to be effective in managing needle-related pain. Eutectic mixture~     of local anaesthetic (EMLA) cream is the topical anesthetic most used. The application of~     this mixture of lidocaine and prilocaine reduce pain during needle procedures in children. To~     be effective EMLA cream must be applied for at least 60 minutes before needle procedure. This~     is the major limitation for its use in emergency settings.~      Ralydan patch is a drug delivery system designed to release local anaesthetics (lidocaine and~     tetracaine) through the skin. There is evidence of pain relief after 30 minutes from its~     application. Only one randomized controlled trial compared the two topical anaesthetics in~     children during venipuncture and showed that Ralydan patch led to superior analgesia than~     EMLA cream, even if in this study the two anaesthetics were applied only for 35 minutes~     before needle procedure. No differences were found in success rate of the procedure and vein~     visibility. In adult patients, Ralydan and EMLA were equally effective in pain relief after~     60 minutes from application.~      To the best of the investigators' knowledge there is no published study that compared needle~     procedure success rate in children and pain relief effectiveness of lidocaine/tetracaine~     patch and lidocaine/prilocaine cream, at time of their maximum analgesic effect.~      The aim of this study is to compare Ralydan patch and EMLA cream at time of their maximum~     analgesic effect (30 minutes vs 60 minutes), regard to needle procedure success rate at the~     first attempt and pain relief in children.~   "
80012|NCT02519647|"~     Intubation with an unchanneled videolaryngoscope mandates the use of a stylet. The Gliderite~     is a stylet specially designed for videolaryngoscopes. The investigators aim to compare the~     efficacy of a new designed bougie for intubation in patients with simulated difficult~     airways.~   "
80013|NCT02519634|"~     Shock wave lithotripsy (SWL) is recommended for kidney stones < 20 mm. However, the stone~     clearance of lower pole calculi after SWL is limited, thus leading to an extended indication~     for mini-percutaneous nephrolithotripsy (PCNL) even for stones between 10 and 20 mm in many~     centers. This trend is further promoted by introduction of super-mini PCNL (SMP), which is~     postulated to be less invasive compared to mini-PCNL due to the miniaturized instruments.~     However, this issue remains controversial.~      On the other hand, improvements in endoscopy technology have made retrograde stone removal~     more attractive. This has led to an increasing use of RIRS as a primary treatment although it~     is recommended only as 2nd-line option by current guidelines. However, the treatment of~     symptomatic lower pole calculi is a challenge for RIRS because of lower clearance rates.~      The purpose of this study is to evaluate the efficacy and safety of SMP and RIRS for the~     treatment for symptomatic lower pole calculi renal calculi measuring 10-20 mm.~   "
80014|NCT02519621|"~     This study is designed to assess the efficacy and economics of two NPWT branded devices of~     wound healing outcomes. It is also designed to assess the effectiveness of negative pressure~     and negative pressure with continuous irrigation on multiple parameters of wound healing. It~     is a single-center, open-label, active controlled, parallel-group trial that aims to~     determine the efficacy of Quantum with simultaneous irrigation in the treatment of diabetic~     foot ulcers. Specifically, eligible participants will be randomized to receive either PRO~     negative press therapy with simultaneous irrigation; or PRO negative pressure therapy without~     irrigation; or KCI Ulta negative pressure therapy.~   "
80015|NCT02519608|"~     This is an investigator-initiated, prospective, single-centre, randomised, phase II,~     open-label study, testing the superiority of ticagrelor, as compared to clopidogrel, in~     modulating on-P2Y12 treatment platelet reactivity, endothelial dysfunction and inflammation~     in chronic obstructive pulmonary disease (COPD) patients receiving scheduled percutaneous~     coronary intervention (PCI) for stable coronary artery disease. Subjects that meet the~     inclusion criteria and have provided informed consent will be randomly assigned in a 1:1~     fashion to one of the two dual antiplatelet therapy (DAPT) regimen: aspirin + clopidogrel~     (standard of care) vs. aspirin + ticagrelor (experimental arm).~      DAPT with aspirin and clopidogrel for at least 6 months (preferably 12 months) is the current~     gold-standard for patients receiving PCI and drug eluting stent implantation for SCAD. No~     data supports a different strategy and/or approach in COPD patients undergoing PCI.~     Ticagrelor, a new P2Y12 inhibitor, showed a significantly higher platelet inhibition as~     compared to clopidogrel. Recently, ticagrelor administration has been associated with a~     positive effect on endothelial function and a modulation of proinflammatory signalling. These~     actions are mediated by a significant influence of adenosine uptake. Higher platelet~     reactivity, chronic inflammatory response, heightened endothelial dysfunction characterized~     COPD patients with concomitant coronary artery disease (CAD). The investigators speculated~     that COPD patients undergoing PCI for stable CAD (SCAD) had a risk profile similar to that of~     acute coronary syndromes (ACS) patients. Accordingly, COPD patients undergoing PCI for SCAD~     may obtain a stronger benefit by ticagrelor as compared to clopidogrel. The aim of this study~     is to evaluate whether ticagrelor, is superior to clopidogrel, in reducing endothelial~     dysfunction , platelet reactivity (PR) and inflammation profile of patients with stable CAD~     and COPD. Ticagrelor will be administered according PLATO trial and international guidelines~     (180 mg as loading dose, 90 mg x 2 daily as maintenance dose). As suggested by international~     guidelines, the control group will be patients with current gold standard treatment for SCAD~     treated with PCI (aspirin + clopidogrel 75 mg daily). The evaluation of endothelial~     dysfunction, PR and inflammation profile will be repeated after 30 days and will be compared~     to baseline values.~   "
80016|NCT02519595|"~     There is a wide variation of published IV ketamine dosing regimens used for procedural~     sedation in children in the Emergency Department (ED). The purpose of the study was to~     compare the efficacy, duration of sedation and adverse events between the three commonly~     administered doses of IV ketamine (1 mg/kg, 1.5 mg/kg and 2 mg/kg) using the traditional~     administration method of 30-60 second infusion for ED sedation in children.~   "
80017|NCT02519582|"~     Phase II trial evaluating the safety and efficacy of oral appliqued niclosamide in patients~     who are progressive with metachronous or synchronous metastases of colorectal cancer among~     the previous therapy (Nikolo). Monocentric open-label clinical trial of phase II. All~     patients received 2 g p.o. niclosamide daily until progression (according to RECIST) or~     unacceptable toxicity or discontinuation of study for other reasons.~   "
80018|NCT02519569|"~     A considerable proportion of bereaved individuals experience chronic and disabling grief~     (so-called complicated or prolonged grief). Complicated grief is associated with severe~     mental and physical health problems as well as impaired social and occupational functioning.~     Interventions based on cognitive-behavioral therapy and applied via the internet have shown~     to be efficacious for this condition, but have not yet been adapted and evaluated in Norway.~     The aim of the current study is to adapt an internet-based cognitive-behavioral intervention~     for complicated grief and evaluate its effectiveness as a pilot study.~   "
80022|NCT02519517|"~     Investigators studied 15 patients scheduled for pulmonary resection through thoracotomy.~     Initial tidal volume (VT) 10ml kg-1 was reduced to 8ml kg-1 after one lung ventilation (OLV)~     and the rate adjusted to maintain partial pressure of arterial carbon dioxide (PaCO2) 30-35~     mm Hg. Data were obtained at: T1, 15 min post establishing OLV with normocapnia, T2, 15 min~     post establishing OLV with hypercapnia (PaCO2 7.98kPa (60mmHg) and 9.31kPa (70mmHg) and pH~     >7.1), and T3, 15 min after resuming OLV with normocapnia. One-way repeated measures analysis~     of variance (ANOVA), with post hoc Dunnet´s test were used for analysis. A P value < 0.05 is~     considered statistically significant.~   "
80023|NCT02519504|"~     The purpose of this study is to learn about Duarte galactosemia (DG). This study will examine~     the possible effects of Duarte galactosemia (DG) in children, and determine whether dietary~     exposure to milk in infancy or early childhood is associated with developmental outcomes of~     school-age children with Duarte galactosemia (DG).~   "
80024|NCT02519491|"~     Accessing the arteries of the heart through the blood vessels of the wrist is becoming~     increasingly popular. By obtaining access via the artery in the arm as opposed to the groin,~     there is less risk of complications and improved patient satisfaction. However, using the~     wrist can cause blockage of the artery after the procedure. If there is too little blood flow~     from a second artery that supplies the hand, this could result in significant injury.~     Therefore, it is important to test these blood vessels in the wrist prior to having this~     procedure. The best way to evaluate these arteries involves the use of ultrasounds but this~     takes a long time and is expensive. Therefore, the artery is usually evaluated with a~     clinical test known as the modified Allen's test, which relies on the doctor watching the~     flushing of the hand during compression of the artery. Currently smart phones with cameras~     are able to assess blood flow by passing light through the skin and watching differences in~     brightness. This may be a better way to assess the arteries in the hand as it is less~     subjective than simply watching the flushing of the hand. This study aims to assess the~     ability of an iPhone application in determining whether there is sufficient blood flow~     through the arteries of the wrist and comparing it to the clinical test commonly used.~   "
80025|NCT02519478|"~     The purpose of the study is to determine the effectiveness of the helmet-less tackling~     training (the HuTT Technique) intervention to reduce head impacts in high school football~     players and to gain an understanding of the neurocognitive effects of repetitive head impacts~     in football. The investigators hypothesis is that the HuTT Technique will result in a reduced~     frequency and magnitude of helmet impacts than the control group measured by a head impact~     measurement system. Also, the investigators hypothesize the HuTT Technique group will~     demonstrate less changes in neurocognitive scores in the mid and post season evaluations~     compared to the control group. Head impacts will be measured using the SIM-G impact monitor~     made by Triax Technology. The SIM-G impact monitor measures the location, magnitude, and~     direction of every head impact in real time and is stored on a protected cloud-based system.~     The sensor is worn by each athlete in a headband or skullcap. Neurocognitive function will be~     measured using the Immediate Post-concussion Assessment and Cognitive Testing (ImPACT) test.~     The test is used as a tool to determine baseline neurocognitive function and is used in~     comparison if an athlete was to be injured to ensure he/she returns to baseline. ImPACT~     measures memory (verbal, visual, working), processing speed and reaction time using a variety~     of tests. Subjects will be recruited from local high school football teams and will include~     freshman, sophomores and juniors. Since the study is expected to run for 2 years, seniors~     will not be eligible for participation. The target is to recruit at least 150 total subjects.~     All subjects will be equipped with a new helmet that is fitted to their head and a headband~     that will be used to hold the head impact telemetry sensor. In addition, all subjects will~     take an ImPACT test preseason, midseason and postseason. At the conclusion of each season,~     all of the impacts from the SIM-G impact monitor system and ImPACT test scores will be~     analyzed. The relevant outcome measures to be analyzed include head impact frequency,~     location, magnitude, symptom scores, memory, visual motor speed and reaction time composite~     scores. Statistical analysis will be used to determine if the HuTT intervention minimized~     head impacts and neurocognitive decline compared to the control group.~   "
80026|NCT02519465|"~     The aerosol associated with noninvasive ventilation (NIV) and high flow therapy with nasal~     interface have been employed in an attempt to relieve respiratory distress and optimize the~     deposition of drugs by inhalation.~      Some studies report the effects of NIV association with fogging in healthy subjects,~     asthmatics and COPD 7.8, but studies evaluating the association between high flow nasal mist~     interface and therapy are scarce and most are found in vitro and animal models. The objective~     of this study is to evaluate the deposition of the aerosol scintigraphy using the high flow~     nasal interface system with vibrating mesh nebulizers using in healthy adults.~   "
80027|NCT02519452|"~     The purpose of the study is to evaluate the pharmacokinetics and safety from the mixture of~     daratumumab and rHuPH20 prepared immediately before administration via Subcutaneous (SC)~     delivery (Part 1) and CF (co-formulated daratumumab and rHuPH20 preparation) administration~     via SC delivery of daratumumab (Part 2).~   "
80028|NCT02519439|"~     A follow-on, two-year open-label extension study of ganaxolone as add-on therapy in adult~     patients with drug-resistant partial-onset seizures~   "
80029|NCT02519426|"~     The study evaluates and validates a new classification proposed by Juodzbalys and Daugela in~     2013 predicting the complexity of impacted mandibular third molars surgical extraction,~     comparing it with other two, scientifically approved (Pell and Gregory, Winter)~     classifications.~   "
80030|NCT02519413|"~     The primary objective of the study is to retrospectively investigate changes in lymphocyte~     counts and lymphocyte subtypes, with a focus on CD4+ and CD8+ T cells, in participants on~     Tecfidera therapy for at least 6 months. The secondary objective is to investigate changes in~     lymphocyte subtypes other than CD4+ and CD8+ T cells.~   "
80031|NCT02519400|"~     A total of 24 healthy Korean male subjects will receive a single oral dose of amitriptyline,~     25 mg. Subjects will be enrolled in this study based on their cytochrome P450 2D6 and~     cytochrome P450 2C19 genotypes, and serial blood sampling will be done for plasma~     concentrations of amitriptyline, nortriptyline, and their metabolites. Various~     pharmacodynamic markers related to the adverse event of amitriptyline will be measured~     serially during the study.~   "
80032|NCT02519387|"~     This is a phase IV, open-label and single-arm study of patients with non-malignant pain due~     to osteoarthritis, rheumatoid arthritis, low back pain and joint/muscle pain, who were not~     responding to non-opioid analgesics. The primary objective was to assess the efficacy of~     buprenorphine transdermal patch for pain control among these patients.~   "
80033|NCT02519374|"~     Assessment of the digestive tolerability of the PROMITOR® .~   "
80141|NCT02517957|"~     On the basis of Xiashi skin surgery clinical experience, this project adopts the multicenter,~     randomized, double-blind, controlled trial of design type. Objective, normative evaluation of~     traditional Chinese medicine cool blood latent town effectiveness of therapeutic regimen in~     the treatment of eczema, security, and control of the relapse of situation, provide~     high-level evidence-based basis for traditional Chinese medicine treatment of eczema, aims to~     form suitable for popularization and application of traditional Chinese medicine in the~     treatment of eczema.~   "
80034|NCT02519361|"~     Aging cause specific changes in the immune system. Processes like immunoessence and~     inflammaging offend the functioning of the immune cells and expose the elderly patient to~     infections that can lead to morbidity and death.~      Protein translation regulation offers a strategic advantage to the immune cells, because it~     enables rapid activation or termination of synthesis of specific proteins, required for~     inflammation or its resolution. Translation initiation depends on recruitment of eukaryotic~     initiation factor eIF4F complex.~      The aim of the current study is to investigate the involvement of the translation initiation~     factors (eIF4E and eIF4G) in the process of recovery from acute infection in elderly patient~     admitted to the internal department with an acute infection.~   "
80035|NCT02519348|"~     This is a multicenter, open-label, stratified, randomized study to evaluate the safety,~     tolerability, antitumor activity, PK, pharmacodynamics, and immunogenicity of MEDI4736~     (Durvalumab) in combination with tremelimumab, MEDI4736 monotherapy or tremelimumab~     monotherapy in subjects with unresectable hepatocellular carcinoma.~   "
80036|NCT02519335|"~     Cardiopulmonary bypass and arrest of the heart during cardiac surgery are necessary to allow~     the surgeon to perform heart operations. However, these processes can cause injury to the~     heart which may worsen post-operative outcomes. In fact, the effects of these injuries may~     continue after surgery, and lead to a long-term decrease in heart function. Neonates and~     young infants are at particular risk for this occurrence.~      While much research has been done in adults looking for medicines that might protect the~     heart during surgery, few studies have been conducted in neonates and young infants. The~     investigators are testing Dexrazoxane, which has proven to be cardio-protective in pediatric~     cancer patients, in the hope that it may lessen cardiac injury during and after congenital~     heart surgery, and thereby improve outcomes in the neonatal and young infant population.~      In order to accomplish this, the investigators must first determine how Dexrazoxane can be~     safely administered to young children with congenital heart disease. Therefore, the~     investigators are performing a pilot study of 12 children to assess:~        1. how Dexrazoxane at 3 different doses is metabolized in the body of a child age 0-6~          months during and after congenital heart surgery, and~        2. the safety of Dexrazoxane use in the neonatal and young infant population undergoing~          cardiac surgery.~   "
80037|NCT02519322|"~     You are being asked to take part in this study because you have melanoma that is metastatic~     (has spread) and you are going to have surgery to remove the disease.~      The goal of this clinical research study is to learn if giving nivolumab alone or in~     combination with ipilimumab before and after surgery can help to control metastatic melanoma.~     The safety of these drugs will also be studied.~      This is an investigational study. Ipilimumab and nivolumab are FDA approved and commercially~     available to treat metastatic melanoma. It is investigational to give the drugs in~     combination before and after surgery. The study doctor can explain how the study drugs are~     designed to work.~      Up to 38 participants will be enrolled in this study. Up to 32 will take part at MD Anderson.~   "
80038|NCT02519309|"~     The primary purpose of this research is to demonstrate the therapeutic effects of~     implementing a well-formulated low carbohydrate lifestyle program over 2 years in patients~     with type 2 diabetes, pre-diabetes, and metabolic syndrome.~   "
80039|NCT02519296|"~     In this article, the investigators report the design and protocol of a functional magnetic~     resonance imaging study (fMRI) of the treatment of Danish veterans with PTSD with Prolonged~     Exposure Therapy (PE). In total 30 Danish veterans will be recruited, who meet the ICD-10~     diagnostic criteria for PTSD, and treated with PE. A group of controls will be recruited~     consisting of age-appropriate same sex veterans who have participated in international~     missions similar to the patient group~   "
80040|NCT02519283|"~     Approximately 20-30% of patients presenting with acute heart failure are discharged from the~     ED. Compared to patients discharged from the hospital, they more frequently return to the ED~     and hospital for further management. While inpatient discharges are often enrolled in~     transitions programs and have their care tailored to evidence-based recommendations, ED~     discharges do not. The investigators propose to evaluate current standard ED discharge to an~     ED-based intervention which will transition patients to outpatient follow-up on~     guideline-recommended therapy.~   "
80041|NCT02519270|"~     A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and~     Pharmacokinetics of Multiple Intravenous Doses of IGN002 Administered Weekly to Subjects with~     Refractory Non-Hodgkin Lymphoma (NHL)~   "
80042|NCT02519257|"~     Atherosclerosis is an inflammatory process in which immune mechanisms interact with metabolic~     risk factors to initiate, propagate, and activate lesions in the arterial trees and is known~     as the main cause of coronary artery disease (CAD). Recently, there are more and more studies~     highlighted the potential importance of adipose tissue in relation to inflammation effects on~     CAD pathogenesis. However, it remains unclear whether Thy-1, adiponectin or any other~     inflammatory mediators in mediastinal adipose tissue contribute to CAD. In this study, we aim~     to analyze the expression of inflammatory mediators' expression via in vitro assay (3T3-L1~     cell culture) and in vivo assay (human adipose tissues).~   "
80043|NCT02519244|"~     The purpose of this study is to investigate whether a wearable robotic exoskeleton can help~     people with multiple sclerosis (MS) to walk again.~   "
80044|NCT02519231|"~     Studies indicate that bleeding irregularities and dysmenorrhea are common reasons for copper~     IUD method discontinuation. Some evidence suggests that non-steroidal anti-inflammatory~     medications (NSAIDs) can help improve bleeding during Cu-IUD use. However, these studies did~     not examine NSAID use with the TCu380A specifically, nor did they evaluate readily available~     NSAIDs such as over-the-counter naproxen. For this reason, the investigators propose a pilot~     trial in which new TCu380A users complaining of heavy or prolonged menstrual bleeding or~     spotting after 1 month of use are randomized to naproxen or placebo to be taken the first 7~     days of menstruation for three consecutive cycles, and then observed for one cycle without~     treatment.~   "
80045|NCT02519218|"~     The purpose of this study is to collect outcomes data in patients implanted with the Ellipse~     IM HTO Nail System.~   "
80046|NCT02519205|"~     The purpose of this study is to determine how the length of a triage shift (i.e. 4 vs., 8~     vs., 12 hours) affects fatigue levels among triage nurses in the Emergency Department (ED).~   "
96220|NCT02307708|"~     The purpose of the study is to compare the treatment by wearing shoes inclined at~     kinesitherapy because it is the first treatment offered by primary care physicians in chronic~     Achilles tendinopathy.~   "
80047|NCT02519192|"~     This study hopes to determine if a negative pressure dressing is superior to a traditional~     dressing for speeding fistula closure after laparotomy. This study has a broad variety of~     implications. Patient safety is a paramount concern: Investigators hope to identify a~     superior method of wound management which minimizes risk for skin breakdown, sepsis, and~     morbidity. In addition, patient satisfaction would be improved with a method for faster wound~     healing. Finally,implications exist in the realm of a cost-benefit analysis, for example,~     although the VAC method is more costly, it may save money if it speeds healing and prevents~     the need for reoperation. Alternatively, if the VAC method is not shown to be beneficial,~     physicians can avoid using a more costly device with no proven benefit.~   "
80048|NCT02519179|"~     The objective this research is to conduct a within-subject, experimental study that will~     describe mothers' feeding practices during typical bottle-feeding conditions and will examine~     whether removal of visual cues related to the amount of milk/formula in the bottle will alter~     these feeding practices. The investigators hypothesize that mothers will show higher levels~     of infant-directed feeding practices and lower levels of mother-directed feeding practices~     when using opaque, weighted bottles compared to when using standard, clear bottles. The~     investigators also hypothesize that infants will consume less breast milk or formula when fed~     from opaque, weighted bottles compared to when fed from standard, clear bottles.~   "
80049|NCT02519166|"~     In this prospective observational study, the investigators tried assess the presence of~     biofilm on chronic wound samples coming from a large cohort study of patients, whilst~     cross-referencing the clinical, bacteriological and wound care observations.~   "
80050|NCT02519153|"~     Urolithiasis is one of the most common urological diseases. The risk of urolithiasis is~     estimated to be between 5% and 12% all over the world with increased incidence in male rather~     than female (2:1) respectively . Ureteral stones account for 20% from all urinary tract~     stones, more than 70% of the ureteral stones found in the lower third of the ureter . The~     incidence of urinary stones has been increasing day by day. Medical expulsive therapy (MET)~     of ureteral stones is the investigators' concern in this study. Stone location, size, number,~     ureteral spasm, mucosal edema or inflammation and ureteral anatomy are the factors affecting~     passage of the ureteral stones. So, MET is based on mechanism that stone passage is~     facilitated by the relaxation of ureteral smooth muscle , increasing hydrostatic pressure~     proximal to the stone and decreasing exciting edema . There are many oral medication could be~     used as MET such as adrenergic blockers, calcium channel blockers, prostaglandin synthesis~     inhibitors, glyceryl trinitrate and steroid treatment . Calcium-channel blockers and~     adrenergic α-antagonists are the main that has been proposed to enhance stone passage as~     expulsive medical therapy. Cyclic nucleotides are degraded by phosphodiesterases enzymes~     (PDEs). So using of PDE inhibtors may play role in relaxation of smooth muscle of the ureter.~     A study was done for evaluation of three PDE5 inhibtors, sildenafil , vardenafil and~     tadalafil, they found that PDE5 inhibitors can reverse the tension of isolated human ureteral~     smooth muscle via cGMP-mediated pathways.~   "
80051|NCT02519140|"~     This is a study to determine how the viscosity (thickness) of an FDA approved gel made by~     Cook medical affects the ease in which endoscopic mucosal resections (EMR) - a type of~     endoscopic surgery performed for localised cancer - can be performed when the gel is injected~     submucosally. The lifting characteristics of the gel will be assessed by height and diameter~     and ease with which the subsequent EMR dissection can be performed. These characteristics~     would be assessed on excised human stomachs and colon, which are harvested during routine~     sleeve gastrectomy surgeries or colectomies, in an ex-vivo manner.~   "
80052|NCT02519127|"~     This study is testing the effectiveness of a dietary intervention by means of measuring the~     change in RQ upon a hyperinsulinemic euglycemic clamp challenge and by means of measuring the~     kinetic responses of multiple PF markers (including RQ) to an acute mixed meal challenge~     before and after a 6-week dietary intervention. The challenges will be applied to investigate~     whether the kinetic response is a better measure for health and wellbeing when compared to~     fasting (baseline) levels. In addition, several measures that reflect perceivable benefits~     like mood, quality of life, sleep quality, cognitive and physical performance will be~     assessed in a first exploratory attempt to link (changes in) PF to consumer perceivable~     benefits.~      Subjects will be randomly allocated to a low glycemic load diet or a 'Western' diet for 6~     weeks. Before and after the intervention several measurements will take place. The low~     glycemic load diet will be high in polyphenols, protein, vegetables, pulses, fibres and nuts,~     and low in glycemic carbohydrates. All these dietary factors have been shown to improve~     glycemic control and/or to reduce metabolic syndrome risk factors.~   "
80053|NCT02519114|"~     The aim of this phase 2 study is to demonstrate that KIR-ligand mismatched haploBMT with~     post-transplant cyclophosphamide will improve progression free survival in poor risk multiple~     myeloma patients.~   "
80054|NCT02519101|"~     Continuous noninvasive blood pressure monitoring may help to avoid intraoperative Hypotension~     or Hypertension~   "
80055|NCT02519088|"~     The study evaluates the patient related risk and predictive factors concerning perioperative~     homologous blood cell transfusion (erythrocyte concentrate ) in THA patients in one EndoCert~     max-certified orthopedic hospital in Germany.~      A patient oriented preoperative decision-making algorithm (a personalised Patient Blood~     Management or pPBM App) will be developed as a new patient-safety blood-sparing strategy.~      The aim is to increase the patient safety by using the pPBM App and to reach a more efficient~     management of resources.~   "
80056|NCT02519075|"~     Prospective exploratory study specifically investigating the diagnostic and predictive role~     of 11C-Choline PET/CT and DWI MRI for response assessment in patients affected by HCC and~     candidate to TARE. A minimum number of 20 patients will be considered for the analysis.~   "
80057|NCT02519062|"~     This is a retrospective study that involves the revision of clinical, instrumental and~     pathologic data of an estimated cohort of maximum 130 patients with NSCLC treated with~     surgery with radical intent at our center.~   "
80058|NCT02519049|"~     Prospective exploratory study specifically investigating the role of 11C-Methionine PET/CT~     imaging in patients affected by Malignant Pleural Mesothelioma (MPM) and candidate to~     pleurodesis.~   "
80059|NCT02519036|"~     This study will test the safety, tolerability, pharmacokinetics and pharmacodynamics of~     multiple ascending doses of IONIS-HTTRx administered intrathecally to adult patients with~     early manifest Huntington's Disease.~   "
80060|NCT02519023|"~     Laparoscopic and Robotic assisted hysterectomy is a surgical procedure that is a minimally~     invasive way in which to remove the uterus, which has less scarring and fewer complications.~     However, this procedure, much like its open-surgical counterpart, is often associated with~     significant post-operative pain. To augment this pain there are many different analgesic~     techniques available to offset pain. Ultrasound-guided transversus abdominis plane (TAP)~     block is one such procedure involving the injection of a local anesthetic into the plane of~     the transversus abdominal muscle where the terminal branches of nerves lie. A similar, yet~     different analgesic approach is that of direct injection of local anesthetic into the~     incision by the surgeon during or just after surgical procedures. These two approaches have~     both been proven to decrease post-operative pain in patients for many procedures, but never~     compared to one another.~   "
80061|NCT02519010|"~     Comparative randomized, single dose, two-way crossover open-label study to determine the~     bioequivalence of Amlodipine / valsartan from Amlodipine/Valsartan 10/160 film coated tablets~     (Pharmacare, Palestine) and Exforge 10/160 film coated tablets (Novartis Pharma, USA).~   "
80062|NCT02518997|"~     Reading to children is believed to be beneficial to cognitive and mental development.This~     study will examine the response of premature Neonatal Intensive Care Unit (NICU) infants to~     bedside reading by measuring changes in heart rate, blood pressure, breathing and oxygen~     levels. The investigators will follow rates of common preterm health issues while in the~     hospital and time to hospital discharge. Effects of bedside reading on parental stress and~     infant bonding will be measured and compared to usual rates of these indicators to determine~     if reading to babies reduces stress and enhances bonding.~   "
80063|NCT02518984|"~     Given the advances in Atrial Fibrillation (AF) management and the availability of new~     European Society of Cardiology (ESC) guidelines, there is a need for the systematic~     collection of contemporary data regarding the management and treatment of AF in the member~     ESC countries. It is now nearly 10 years since the last European registry of AF management~     was undertaken (as part of the ESC Euro Heart Survey programme), and a new registry was~     needed.~   "
80064|NCT02518971|"~     The study aims to evaluate the efficacy of prophylactic tamsulosin in reducing the incidence~     of postoperative urinary retention in primary total knee and hip arthroplasty patients.~   "
80065|NCT02518958|"~     This is a dose escalation protocol to determine the feasibility of co-administration of~     RRx-001 and nivolumab. Immune surveillance is an endogenous mechanism to cause remission of~     neoplastic growth. Epigenetic agents like RRx-001 are associated not only with enhanced gene~     transcription and restored expression of silenced genes but also with increased expression of~     pro-inflammatory mediators, upregulation of PD-L1 on tumor cells and de-repression of~     antigens that promote immune recognition of tumors. It is hypothesized that RRx-001, will~     prime or sensitize to immune checkpoint therapy targeting PD-1 interaction with nivolumab.~   "
80066|NCT02518945|"~     This is a single center, prospective, randomized, double blinded placebo controlled study~     conducted I patients with type 1 diabetes.The aim of this study is to examine the additive~     effects of GLP-1 agonist and SGLT2 inhibitor in patients with type 1 diabetes in terms of~     possible improved glycemic control, reduced glycemic variability, reduced insulin dosages,~     additional effects of weight loss and blood pressure reduction.~   "
80067|NCT02518932|"~     To asses the modulating properties of the cleaved pentapeptide product of GLP-1 amide.~   "
80068|NCT02518919|"~     The role of Adjunct therapies such as Child Life therapy and Music listening during~     Procedural Sedation and Analgesia(PSA) for children during painful procedures has not been~     studied in the Emergency Department (ED). The investigators hypothesize that there will be a~     reduction in sedation medication dosage without change in sedation efficacy by addition of~     music therapy and Child Life to standard sedation protocol in children 3-15 years of age who~     undergo PSA for painful (orthopedic procedures, laceration repair, incision and drainage)~     procedures in a Pediatric emergency Department (PED).~   "
80069|NCT02518906|"~     Specialized treatment of personality disorders (PD) in youth has been neglected for a long~     time, because these disorders were not diagnosed before the age of 18. Since 2013 the age~     threshold has been dropped in the Diagnostic and Statistical Manual (DSM)-5, and such change~     is also announced for the International Classification of Diseases (ICD)-11. There is broad~     consensus from both scientific evidence and clinical experience that specialized early~     interventions in adolescents with PD are urgently needed.~      In the last decades a number of specialized psychotherapeutic treatment programs have been~     developed. Despite their conceptual differences, many of the treatment models have shown~     significant effects in the treatment of PD in adults. However, the treatment of adolescents~     with PD remains difficult and further enhancement and development of treatments is needed.~      Given the different therapeutic approaches available, the present project aims to go beyond~     the comparison of integral therapeutic models in the classical outcome study design. While~     outcome research is important to build on the evidence of the effectiveness of an~     intervention, it contributes little to its understanding and refinement. The aim of the~     present multi-center project is to compare two therapeutic methods used in routine care:~        -  Adolescent Identity Treatment (AIT)~        -  Dialectic Behavioral Treatment for Adolescents (DBT-A)~      Treatments will be performed at different study centers and compared using the same measures~     of outcome. The main outcome will be psychosocial functioning.~      Additionally, the psychotherapy process will be investigated to explore specific and~     unspecific mechanisms of the therapeutic process, its outcome and mediators.~   "
80070|NCT02518893|"~     The purpose of the study is to describe service members' experiences as participants in~     health research, including their reasons for deciding for or against research participation.~   "
80071|NCT02518880|"~     To understand the cardiovascular reactions of the human body to changing conditions of~     gravity is an important aim of space science. In this context, cardiac output (CO) is a key~     value to estimate the human cardiovascular system.~      The main objective of this experiment is to determine the effects of parabolic flight on~     intravascular volume, and how these changes modulate the complex haemodynamics induced by the~     parabolas.~   "
80145|NCT02517905|"~     This is a Phase 3, randomized, double-blind, placebo-controlled study in subjects scheduled~     to undergo elective bilateral third molar extraction under local anesthesia. At least one~     lower mandibular third molar must involve full or partial bony impaction confirmed by visual~     or radiographic evidence.~   "
80072|NCT02518867|"~     Transcranial magnetic stimulation (TMS) has opened new potential avenues for the treatment of~     neuropsychiatric diseases via the effects of modulation on neuroplasticity. Repetitive TMS~     (rTMS) is a non-invasive method of stimulation neural pathways in the brain of conscious~     subjects through the intact scalp. The investigators hypothesize that excitatory rTMS applied~     over the motor cortex would increase motor cortex activity and result in an increase in the~     inhibitory input through the corticospinal tract to the spinal cord, thus reducing alpha~     neuron hyperactivity and consequently clinical spasticity. In this study, the investigators~     will apply the stimulation on the legs motor cortex area, which can cover supplemental motor~     area (SMA). Therefore, not only the spasticity, but also the motor control of legs both can~     be modulated by stimulation. Theta burst stimulation is a condition of rTMS which was~     designed by the co-investigator. It has controllable, consistent, long-lasting, and powerful~     effects on motor cortex physiology and behavior. The investigators therefore design this~     protocol using theta burst stimulation on the motor cortex of the patients of cerebral palsy.~     The investigators expect that there would be an effect on the reduction of spasticity after~     rTMS on the brain of children with CP, thus improving the motor control of legs.~   "
80073|NCT02518854|"~     Metabolic syndrome (MetS) is highly prevalent all over the world. MetS is largely~     under-diagnosed in children and adolescents. Obesity and hypertension are two important~     requirements for criteria of MetS. With early detection and early intervention of MetS in~     children and adolescents will enable better care to reduce the heavy burden of health care~     all over the world.~      Investigators intend to recruit 150 children and adolescents age 6 to 18 yr with~     overweight/obesity or prehypertension/hypertension and 50 normal age-matched controls to~     reach the following research goals:~      1) To identify biomarkers as risk factors; 2) To characterize that impact of vascular~     assessment in preMetS children; and 3) To examine the relationship among biomarkers, vascular~     assessment parameters, and metabolic phenotypes.~   "
80074|NCT02518841|"~     The investigators will compare Achilles tendon stretching with a new product called a~     ThermaWedge™ device, a foam wedge designed to help with certain foot stretches and exercises,~     in the treatment of chronic plantar fasciopathy. There will be 2 groups each of 25 - 30~     participants who have chronic plantar fasciopathy, which is a common cause of foot pain.~     Exercises will be done for 6 weeks and then each group will do the other exercise protocol~     for another 6 weeks. Participants will fill out the Foot and Ankle Disability Index scale and~     numerical analog pain scale and the Global Rating of Change Scale prior to any treatment,~     weekly during treatment and post treatment. The investigators' hypothesis is that use of the~     ThermaWedge™ device will result in decreased pain and disability when compared to achilles~     tendon stretching.~   "
80075|NCT02518828|"~     The primary objective of this pilot trial is to determine whether inpatients presenting to~     the Emergency Department (ED) with symptoms suggestive of Acute Heart Failure (AHF), who~     receive supplemental oxygen adjusted at either a high (SpO2 range ≥96%) or low (SpO2 range~     90-92%) oxygen saturation level, leads to greater reduction in N-terminal-proBNP (NT-proBNP)~     at 72 hours.~   "
80076|NCT02518815|"~     This study examined whether 20 minutes of prewarming prior to gynecological laparoscopic~     surgery prevented inadvertent post-operative hypothermia. Treatment group received prewarming~     using a forced air body warming, control group received no active warming system. Both groups~     were then warmed with forced air warmer intraoperatively.~   "
80077|NCT02518802|"~     This randomized phase III trial is studying gefitinib and synchronous pemetrexed/cisplatin~     chenmotherapy to see how well it works compared to pemetrexed/cisplatin chenmotherapy alone~     in treating patients who have undergone surgery for stage II-IIIA(N1-N2) lung adenocarcinoma~     with EGFR activating mutation in Asian population.~   "
80078|NCT02518789|"~     By observing the difference of plasma homovanillic acid concentrations and brain electrical~     consciousness monitoring Narcotrend index, study the possible mechanism of influencing~     Etomidate induced myoclonus with Dexmedetomidine pretreatment during general anesthesia~     induction period.~   "
80079|NCT02518776|"~     Multiple sclerosis (MS) is an inflammatory disease of the central nervous system responsible~     for physical disability but can also cause cognitive disturbances annoying social and~     professional life of patients with the disease. Various studies have shown that there was a~     breach of episodic memory, working memory, attention and executive functions regardless of~     the form of disease, disability or duration of disease progression.~      The main objective of this study is to investigate the influence of emotional components and~     executive processes on the components retrograde and anterograde episodic memory (thanks to~     an original paradigm based on the emotional valence of the memory) in MS patients~   "
80080|NCT02518763|"~     The vitamin D deficiency (25OHD) is very common and affects about 80% of the population of~     French osteoporotic women over 50 years [5]. It contributes significantly to bone fragility~     and consequently the risk of fracture. To remedy this deficit, it is necessary to provide a~     suitable and sustainable supplementation. Changes in vitamin D deficiency ranging from~     undetectable to a 25OHD value very close to 30ng / ml lead to differences in therapeutic~     regimens, specific to each clinician in the absence of precise data in the literature. No~     consensus on supplementation dosages and methods have been proposed so far. Also, given the~     frequency of vitamin D deficiency including osteoporosis observed in the population, it~     became necessary to establish a single, uniform regimen for all patients with osteoporosis~   "
80094|NCT02518581|"~     The present study is an exploratory trial to establish a feasible DLW (doubly labelled water)~     protocol for implementation in clinical trials conducted at Profil Institut für~     Stoffwechselforschung, investigating treatment options for overweight and obesity in~     populations with and without diabetic comorbidity. The study aims at the practical validation~     of a 1-2-week DLW protocol in overweight and obese type 2 diabetic subjects.~      Total Energy Expenditure (TEE) values as assessed by DLW will then be compared to (1) TEE as~     calculated based on individual anthropometric measurements (including body composition) using~     the Müller formula and the AEE (activity related energy expenditure) based on reported work~     place and leisure time activities and (2) TEE as calculated from measured REE (resting energy~     expenditure) as assessed by indirect calorimetry and the AEE based on information recorded by~     the subjects in a physical activity diary and corresponding pedometer counts. Moreover, TEE~     assessments will be repeated once (separated by 2-4 weeks) to determine intra-subject~     variability / re-test reliability of the measurement.~   "
80081|NCT02518750|"~     This is a phase-II study to evaluate the efficacy of a salvage regimen in children with~     relapsed T-cell ALL or lymphoma. Peg-asparaginase, mitoxantrone, intrathecal triples (IT)~     (intrathecal methotrexate/hydrocortisone/cytarabine) (ITMHA) and dexamethasone are commonly~     used drugs to treat relapsed or refractory acute lymphocytic leukemia or lymphoma (ALL). In~     this study, the investigators want to know if adding three drugs called panobinostat,~     bortezomib and liposomal vincristine (VSLI) to this regimen will result in remission (no~     signs or symptoms of leukemia or lymphoma).~        -  Panobinostat has been approved by the FDA for treating adults with multiple myeloma, but~          it has not been approved for use in children and has not been given together with the~          other drugs used in this study. It has not been widely studied in children.~        -  VSLI has been approved by the FDA for adults with relapsed or refractory ALL, but has~          not yet been approved for treating children with leukemia or lymphoma.~        -  Bortezomib has been approved by the FDA for treating adults with a cancer called~          multiple myeloma and adults with relapsed mantle cell lymphoma; it has not been approved~          for treating children.~      PRIMARY OBJECTIVE:~        -  To estimate the complete remission (CR) rate for patients with T-cell lymphoblastic~          leukemia and lymphoma in first relapse.~      SECONDARY OBJECTIVES:~        -  To evaluate minimal residual disease (MRD) levels at end of each block of therapy.~        -  To describe the toxicities of vincristine sulfate liposome injection (VSLI) when used in~          combination with chemotherapy and bortezomib.~   "
80082|NCT02518737|"~     The bone tissue of the human adult body is in a constant process of break-down (resorption)~     and rebuilding (formation), a process called bone remodeling. The extent to which bone~     remodeling happens varies during the day, especially a decrease in the bone resorption is~     observed after eating.~      The overall purpose of this study is to examine the possible role of the hormone~     Glucose-dependent Insulinotropic Polypeptide (GIP) in Bone Remodeling. GIP is released from~     cells in the gut after eating, and previous studies have shown an effect of GIP on bone~     tissue. In addition, it has been observed that the risk of bone fracture is 60% higher in~     women with a mutation in the GIP receptor, when compared to women with a normal functioning~     GIP receptor.~      In the present study humans with a mutation in their GIP receptor is compared to humans with~     a normal functioning GIP receptor. The study population will be examined during a meal~     stimulation test, where blood will be sampled regularly. The blood samples will be examined~     for markers of bone resorption among other markers of bone remodeling, GIP and other gut~     hormones.~      The hypothesis for the present study is that GIP secreted after meal ingestion inhibits bone~     resorption. Thus it is expected that the decrease in resorption is less pronounced in the~     humans carrying the GIP-receptor mutation, compared to humans with a normal functioning GIP~     receptor.~   "
80083|NCT02518724|"~     In order to examine the effect of RIPC on skeleton muscle exertional damage and on aerobic~     and anaerobic physical performances, 30 healthy volunteers will undergo a series of different~     physical tests twice; once without intervention and a second time with RIPC intervention or~     placebo (false) intervention.~   "
80084|NCT02518711|"~     The goal of this study was to investigate the effectiveness of a behavioral teacher program~     addressing symptoms of Attention-Deficit Hyperactivity Disorder (ADHD) in the classroom.~   "
80085|NCT02518698|"~     The goal of the study is to provide a detailed description of treatments for CRPC (Castrate~     Resistant Prostate Cancer) patients with bone metastases and the resource utilization and~     costs associated with that diagnosis and subsequent treatments.~   "
80086|NCT02518685|"~     The purpose of this clinical research trial is to study safety and effectiveness of the~     TransPyloric Shuttle System (TPSS) for weight reduction in patients who are considered~     medically obese.~   "
80087|NCT02518672|"~     Monoglyceride of DHA (DHA-MAG) is a lipid compound for which intestinal absorption would~     increase the ratio DHA / arachidonic acid (AA) and promote the synthesis of specific~     metabolites involved in the resolution of inflammation.~      The PREMDIC project, initiated at the Centre Hospitalier Universitaire de Sherbrooke, is a~     randomized double-blind study for people with cystic fibrosis (CF) and aims to evaluate~     whether daily supplementation monoglyceride of DHA (a fatty acid omega-3 family) will reduce~     lung inflammation and improve pulmonary function.~   "
80088|NCT02518659|"~     Hypomagnesemia is a severe side effect of longterm use of all available proton-pump~     inhibitors (PPIH). It develops due to intestinal malabsorption of Mg2+.~      This study investigates the application of dietary inulin fibers in users of proton-pump~     inhibitors with such a hypomagnesemia. To this end, repetitive short-term trials of 14 days~     of orally administered inulin, separated by a wash-out period of 14 days each were performed~     in cases of PPIH and controls. This study was not blinded or randomized.~   "
80089|NCT02518646|"~     Currently, two ICU delirium prediction models are available: the PRE-DELIRIC model and the~     early prediction model (E-PRE-DELRIC). However, the use of these prediction models is not yet~     implemented as standard in clinical practice, as it is unknown which delirium prediction~     model can best be used to predict delirium in ICU patients.Therefore the main aim of this~     study is to compare the performance of the PRE-DELIRIC model and the E-PRE-DELRIC model.~   "
80090|NCT02518633|"~     Dysfunctional adipose tissue predisposes to cardiovascular disease. Similarly, the risk of~     cardiovascular disease appears to be increased in subjects with obstructive sleep apnoea.~     Reduced adipose tissue oxygen availability has been described in obesity and may also be a~     mechanism in obstructive sleep apnoea. Hypoxia induces inflammation and fibrosis in adipose~     tissue which are factors contributing to cardiovascular risk. The investigators hypothesize~     that adipose tissue's oxygen uptake is reduced in subjects with obstructive sleep apnoea by~     comparing in vivo AT oxygenation and blood flow in tissue of control subjects.~   "
80091|NCT02518620|"~     The objective of this study is to evaluate the long-term efficacy and safety of ALX-0061~     administered subcutaneously (s.c.) to subjects with active Rheumatoid Arthritis (RA).~   "
80092|NCT02518607|"~     This study is to assess the safety and tolerability aspects of oral MGB-BP-3, a treatment for~     Clostridium difficile infections.~   "
80093|NCT02518594|"~     This protocol outlines a randomized trial of 630 women evaluating the use of micronized~     vaginal progesterone or pessary versus control (placebo) to prevent early preterm birth in~     women carrying twins and with a cervical length of less than 30 millimeters.~   "
80096|NCT02518555|"~     This randomized phase II trial studies how well ibrutinib works when given together with~     vaccine therapies in treating patients without clinical signs or indications that raise the~     possibility of a particular disorder or dysfunction (asymptomatic) who have high-risk chronic~     lymphocytic leukemia or small lymphocytic lymphoma. Ibrutinib may stop the growth of cancer~     cells by blocking some of the enzymes needed for cell growth. Vaccines, such as pneumococcal~     13-valent conjugate vaccine, trivalent influenza vaccine, and diphtheria toxoid/tetanus~     toxoid/acellular pertussis vaccine adsorbed, may help the body build an effective immune~     response to kill cancer cells. Giving ibrutinib together with vaccine therapies may be a~     better treatment for chronic lymphocytic leukemia or small lymphocytic lymphoma.~   "
80097|NCT02518542|"~     Achalasia is an esophageal motility disorder, which leads to clinical symptoms such as~     dysphagia, regurgitation, chest pain and consecutive weight loss.~      Although conventional treatment such as laparoscopic Heller myotomy (LHM) and balloon~     dilatation (BD) can provide sufficient symptom relief in many patients, both interventions~     have their individual drawbacks. Additionally, treatment after failed LHM or BD can be~     challenging and in few might even lead to esophagectomy.~      Per oral endoscopic myotomy (POEM) and prolonged dilatation (PRD) are two novel~     endoscopically performed therapeutic options for achalasia and other esophageal motility~     disorders. Both not only appear to provide good results, when performed as initial treatment~     but also might be an excellent option after e.g failed LHM.~      The purpose of this study is to evaluate the long-term efficacy of four different treatment~     options, such as POEM, PRD with stent-fixation, PD and conventional LHM for achalasia in an~     individualized treatment setting.~   "
80098|NCT02518529|"~     Open-label, multicenter study to assess 250µg/0.2ml G17DT injection at weeks 0, 2 and 6. At~     or after week 20 and up to and including week 44. Subjects who raised antibodies to G17DT~     were given an additional dose of 125µg/0.1ml or 250µg/0.2ml G17DT between weeks 20-44 (study~     duration 52 weeks).~   "
80099|NCT02518516|"~     Statins are a class of cholesterol lowering medications that are prescribed for the~     prevention and treatment of cardiovascular disease. The purpose of this study is to determine~     if there is an excess risk of acute kidney injury (AKI) with high potency statins compared to~     low potency statins.~      The investigators will carry out separate population based cohort studies using~     administrative health care databases in nine jurisdictions in Canada, the US, and the UK.~     Cohorts will be defined by the initiation of a statin, with follow-up until hospitalization~     for AKI. Analyses will be done separately for groups of patients with and without chronic~     kidney disease. The results from the separate sites will be combined in a meta-analysis to~     provide an overall assessment of the risk of AKI in new statin users.~   "
80100|NCT02518503|"~     Statins are a class of cholesterol lowering medications that are prescribed for the~     prevention and treatment of cardiovascular disease. The purpose of this study is to determine~     if there is an increased risk of new diabetes when exposed to high potency statins, compared~     to low potency statins, among patients who had a recent cardiovascular event or procedure.~      The investigators will carry out separate population based cohort studies using~     administrative health care databases in eight jurisdictions in Canada, the US, and the UK.~     The cohort will be defined by the initiation of a statin, with follow-up until a diagnosis of~     incident diabetes or a prescription for insulin or an oral antidiabetic medication. The~     results from the separate sites will be combined in a meta-analysis to provide an overall~     assessment of the risk of new onset diabetes in subjects starting a statin.~   "
80101|NCT02518477|"~     This study will examine whether lymphedema after breast cancer surgery can be reduced. In a~     randomised controlled design the aim is to investigate whether an early intervention with~     progressive resistance training and close monitoring of arm swelling can reduce the incidence~     of lymphedema after breast cancer surgery.~   "
80102|NCT02518464|"~     This is a prospective, open-label, single-arm pilot study treating 40 subjects to assess the~     hypothesis that P2Y, G protein-coupled 12 (P2Y12) inhibition with Brilinta/ticagrelor (90 mg~     by mouth (PO) twice a day) reduces episodic and/or chronic migraine headache symptoms in~     patients with right to left shunt. Headache frequency while on Brilinta/ticagrelor will be~     compared with the documented baseline for each subject. If the Brilinta/ticagrelor therapy~     was effective (> 50% reduction in monthly headache days), the subject could elect to continue~     therapy for an additional two months (56 days), while continuing to complete daily headache~     logs.~   "
80103|NCT02518451|"~     This was a randomized, single-blind, two-period, two sequence cross-over study under fasting~     condition, with a one-week wash-out period, to compare the pharmacokinetic profiles and~     bioavailability of two formulations (the test and reference) of valsartan 160 mg film-coated~     caplets.~   "
80104|NCT02518438|"~     This double-blind, randomized trial examined whether tramadol wound infiltration decreased~     postoperative pain following cesarean delivery under general anesthesia or reduced the need~     for analgesics in the immediate postoperative period. Patients in the tramadol group consumed~     significantly less morphine at all time intervals than those in the control group. The~     investigators suggest that the use of wound infiltration with tramadol may be a useful~     technique in patients who undergo cesarean section under general anesthesia to reduce~     postoperative pain, improve recovery, and facilitate early contact of mothers with their~     babies.~   "
80105|NCT02518425|"~     In a retrospective analysis of already existing clinical assessment data from patients with~     functional voice disorders the following aspects will be sampled, encoded and analysed:~     Outcomes pre and post treatment of~        1. subjective voice symptoms measured by Voice Handicap Index (VHI-9i),~        2. perceptual voice symptoms according to Grading-Roughness-Breathiness-Asthenia-Strain~          Scale (GRBAS Scale),~        3. instrumental acoustic analysis parameters Jitter (%), speaking voice profile: mean and~          range of speaking pitch and intensity, max. intensity and mean pitch of calling voice,~          singing voice: min./max. and range of pitch and intensity, maximum phonation time,~          Dysphonia Severity Index (DSI).~   "
80142|NCT02517944|"~     Patients with familial hypercholesterolemia (FH) at high cardiovascular risk may suffer from~     silent micro-infarctions (MI) before clinical coronary heart disease manifestations because~     of the lifetime exposure to elevated serum LDL-cholesterol levels.~      The study aims to demonstrate the higher prevalence of silent myocardial infarction in a~     population of asymptomatic patients with familial hypercholesterolemia at high cardiovascular~     risk in comparison to control patients using Cardiac Magnetic Resonance sequences of delayed~     gadolinium enhancement.~   "
80106|NCT02518412|"~     The purpose of this study is to investigate transcranial direct current stimulation (tDCS) as~     a cognitive enhancer for patients with Alzheimer disease.~      Transcranial direct current stimulation (tDCS) is a neuromodulation technique, that are~     applied to the brain by using two electrodes. These electrodes are placed on the scalp. The~     current is low intensity, usually 1-2 milliampere. tDCS may affect cognitive functions by~     increasing cortical excitability. tDCS is regarded as a safe treatment approach. In the~     present study, participants will undergo six stimulations. The effect of all stimulations~     swill be measured with neuropsychological testing before the first (pre) and after the sixth~     tDCS stimulation (post).~   "
80107|NCT02518399|"~     The purpose of the study is to investigate whether long-term heat therapy (i.e. 8 weeks of~     hot tub 4-5x per week) improves biomarkers of cardiovascular health in young, healthy,~     able-bodied individuals. Although exercise is a potent means of improving cardiovascular~     health, many patients are unable to exercise effectively, and thus there is high demand for~     novel therapies to better manage cardiovascular risk in these patients. If successful, this~     study will set the groundwork for heat therapy to be used as an alternative treatment in~     patients who have limited exercise capabilities for the prevention of cardiovascular disease.~   "
80108|NCT02518386|"~     Acute self poisoning is a leading cause of suicide attempts and leads to frequent emergency~     department visits. However, the exact epidemiology of acute self poisoning is not known. The~     description of the clinical pathway and the characteristics of patients with acute self~     poisoning could lead to an improvement in emergency care.~      The Investigators will conduct a 48h observational study in emergency services in France.~     Investigators primary objective is to gathered epidemiological clinical and treatment data~     during emergency dispatch, prehospital care and inhospital emergency care.~   "
80109|NCT02518373|"~     This Phase 2 study was an open label, single-center 18-week study to compare basal and meal~     stimulated plasma gastrin levels before and after treatment with 3 intramuscular injections~     of 250 µg G17DT, with and without the concomitant administration of Omeprazole.~   "
80110|NCT02518360|"~     Determine the improvement in nonspecific low back pain patients with osteopathic techniques~     (Body Adjustment Protocol) and know changes in stabilometric measures analyzed with a~     stabilometric platform (Footscan®).~   "
80111|NCT02518347|"~     The proposed study aims to examine the hypothesis that strawberry supplementation will lower~     serum biomarkers of inflammation and improve knee function in patients with symptomatic~     osteoarthritis (OA).~   "
80112|NCT02518334|"~     Many studies have reported that alcoholic beverage consumption, especially in the form of~     wine, reduces the risk of developing type 2 diabetes by as much as 40%. This association~     suggests that wine consumption may somehow improve the body's ability to control its blood~     glucose concentration. Indeed, it has been reported that when wine is consumed immediately~     prior to ingestion of glucose, the release of insulin is enhanced and blood glucose~     concentration is lowered. The mechanism of wine's effects on blood glucose concentration is~     unknown, but is likely related to its ethanol or antioxidant content. In this study, the~     investigators plan to test whether wine or plain ethanol (vodka) ingestion alters the control~     of blood glucose in subjects who have diabetes or pre-diabetes.~   "
80113|NCT02518321|"~     Toileting is a private activity of daily living. Geriatric rehabilitation patients are often~     unable to toilet themselves independently, leading to embarrassment and loss of self-esteem.~     Relationships with their caregivers may also become strained. Furthermore, improper toileting~     hygiene can lead to skin irritation, breakdown and infection.~      Technology-assisted toilets (TATs) clean and dry the anal and vaginal regions using a stream~     of water and a fan. They can therefore potentially eliminate the need for patients to be able~     to wipe themselves. TATs are operated using wall-mounted remote controls. This study will~     examine the potential benefits of TAT use in geriatric rehabilitation patients.~      Forty patients aged ≥65 years referred for treatment of physical impairments to the Geriatric~     Rehabilitation Unit (GRU) of the Elisabeth Bruyère Hospital (EBH) will be recruited for this~     study. Participants will have a bowel movement on two occasions, once using toilet paper and~     once using the TAT. The Psychosocial Impact of Assistive Devices Scale (PIADS), a validated~     questionnaire, will be used to analyze participants' toileting experience. Participants will~     be visually evaluated for cleanliness before and after each testing session.~      The investigators hypothesize that participants will report that, in comparison with use of a~     standard toilet, toileting using the TAT: 1) is easier to use, 2) improves psychological~     well-being and 3) is more effective at cleaning than regular wiping techniques.~   "
80114|NCT02518308|"~     This pilot clinical trial studies how well a mindfulness-based stress reduction (MBSR)~     intervention works in reducing anxiety in patients who have undergone treatment for~     gynecologic cancer but no longer have any sign of disease. Gynecologic cancer is cancer of~     the female reproductive tract, which includes the cervix, endometrium, fallopian tubes,~     ovaries, uterus, and vagina. Side effects from treatment for these cancers may include~     anxiety, fatigue, depression, and sexual function changes. Mindfulness training uses~     meditation and yoga to help patients focus on breathing, bodily sensations, and mental~     awareness. This may help decrease patients' stress and anxiety and improve their quality of~     life, and may also help their immune system.~   "
80115|NCT02518295|"~     The purpose of this study is to assess that two β-galactosidase Producing Probiotic Strains~     help improve lactose digestion in subjects with lactose maldigestion.~   "
80116|NCT02518282|"~     A measurable degree of heart muscle tissue injury is expected in patients undergoing heart~     valvular surgery. The level of this injury can be measured by cardiac biomarkers in blood~     samples. Those biomarkers are used to diagnose an acute myocardial infarction.~      Postoperative myocardial infarction (MI) is a frequent and important complication after~     cardiac surgery with high morbidity and mortality. Therefore it is very important to~     recognize any cardiac event in patients who undergo cardiac surgery. Different diagnostic~     tools can be used to the diagnosis of acute myocardial infarction; however few is known about~     the value of high-sensitivity cardiac troponin T (hs-cTn) to diagnose a MI after heart~     valvular surgery.~      The aim of this study is to determine the upper reference limit of high-sensitivity troponin~     T concentration to consider the diagnosis of acute myocardial infarction in patients~     undergoing heart valvular surgery.~   "
96503|NCT02304016|"~     The purpose of this study is to determine if patients with third and fourth degree obstetric~     lacerations benefit from a short course of pelvic floor physical therapy in the immediate~     postpartum period.~   "
80118|NCT02518256|"~     The ovarian surface, the Fallopian tubes, the uterine cavity and the peritoneal cavity all~     together form a communicating compartment. The physiologic function of the ciliated lining of~     the tubes is to transport the egg, after ovulation, into the uterine cavity. Thus, making it~     very likely that exfoliated cells from pathologic changes of the ovarian surface and~     Fallopian tube lining will be present in a lavage from the uterine cavity.~      The proof of concept that malignant cells from the upper genital tract get transported even~     into the lower genital tract was recently published by Kind I. et al. Liquid-based cervical~     cytology allows not only cytological evaluation but also collection of DNA. A panel of genes~     that are commonly mutated in endometrial and ovarian cancers was assembled with new~     whole-exome sequencing data from 22 endometrial cancers and previously published data on~     other tumour types, including mutations in the TP53 gene. This panel was used to search for~     mutations in 24 endometrial and 22 ovarian cancers and identified mutations in all 46~     samples. With a sensitive massively parallel sequencing method, it was possible to identify~     the same mutations in the DNA from liquid Pap smear specimens in 100% of endometrial cancers~     (24 of 24) and in 41% of ovarian cancers (9 of 22).~      In the current project the investigators will study the specificity and sensitivity of the~     lavage of uterine cavity and proximal tubes as a test to differentiate between malign and~     benign ovarian tumours. The investigators aim to detect cells from EOCs or genetic material~     from those cells in the lavage.~   "
80119|NCT02518243|"~     All over the world the increasing prevalence of chronic disorders and its impact on~     functional decline is challenging the sustainability of health care systems. Older~     individuals also frequently experience the reversible frailty syndrome, which overlaps with~     chronic diseases, increasing incidence of disability.~      Building a global system aiming to take in charge all causes leading to loss of autonomy is a~     rather complicated task involving numerous Information and Communication technologies (ICT)~     solutions which are not always easy to use in everyday life.~      The SafEE (Safe Easy Environment) project aim is to improve the safety, autonomy and quality~     of life of older people at risk.~      The SafEE2 project develop non pharmacological therapeutic through diferent ICT (stimulation~     aromatherapy automatic fragrance ...) .~      The goal of this study is to validate the acceptability, sensitivity and efficacy of the~     systems.~   "
80120|NCT02518230|"~     This study is a single center, prospective cohort crossover study comparing mechanically~     ventilated neonates and infants on Neurally Adjusted Ventilatory Assist (NAVA) and~     synchronized intermittent mandatory ventilation with pressure control plus pressure support~     (SIMV(PC) + PS) modes.~      This design will allow for direct comparison of two commonly used ventilator modalities in~     the neonatal intensive care unit (NICU) to determine if one mode is superior to the other~     with regards to respiratory mechanics and estimated energy expenditure.~      It is hypothesized that neonates and infants will have improved respiratory severity score~     (MAP X FiO2) utilizing NAVA compared to the SIMV (PC) + PS mode but will have increased~     estimated energy expenditure.~   "
80121|NCT02518217|"~     This randomized controlled trial will evaluate patterns of use and health outcomes of the~     ShapeUp Empower online program with and without financial incentives for program engagement.~   "
80122|NCT02518204|"~     The purpose of this study is to evaluate the concurrent validity between the Brain~     Performance Test (BPT) subtests and corresponding conventional in-person neuropsychological~     assessments (NP).~   "
80123|NCT02518191|"~     This prospective randomized controlled study is conducted to analyze the effect of Goserelin~     on ovarian function in women with breast cancer in China.~   "
80124|NCT02518178|"~     This is a three arm cluster randomized controlled trial where the unit of randomization is~     the immunization camp. Immunization camps are the sole provider of vaccinations in our study~     area and have catchment areas of several villages. The 96 immunization camps will be~     randomized evenly to one of three arms:~        1. control arm; where near field communication (NFC) stickers will be placed on existing~          immunization booklets. These stickers can be scanned using a mobile phone with an~          installed application whereby information can be entered onto the phone and then scanned~          onto the sticker~        2. pendant only; where the same NFC technology will be placed into a pendant that is worn~          by the infant, and~        3. pendant as described above with voice reminders sent 15 days, 1 day prior, and the day~          of the scheduled immunization camp dates.~   "
80125|NCT02518165|"~     This study was designed to evaluate the chronic effects of a proprietary spearmint extract~     over 90 days of supplementation on aspects of cognitive performance (cognitive function and~     active reaction time), subjective mood, and sleep quality in healthy men and women.~   "
80126|NCT02518152|"~     The present study is designed to evaluate the combined efficacy of Platelet Rich Fibrin (PRF)~     and 1% Alendronate (ALN) with open flap debridement (OFD) in treatment of intrabony defects~     in chronic periodontitis patients.~   "
80127|NCT02518139|"~     The purpose of this study is to measure the safety and tolerability of TD 4208, an~     investigational drug being developed to treat people with moderate to very severe COPD,~     compared to tiotropium.~   "
80128|NCT02518126|"~     To see if there is a relationship between the level of LIF in IUGR fetuses and compared to~     the level of LIF in AGA fetuses~   "
80129|NCT02518113|"~     The main purpose of this study is to evaluate the safety of the study drug known as LY3039478~     in combination with dexamethasone in participants with T-cell acute lymphoblastic leukemia or~     T-cell lymphoblastic lymphoma (T-ALL/T-LBL).~   "
80130|NCT02518100|"~     This feasibility study evaluates the use of the Vital Signs Patch (VSP) System to take and~     monitor specified vital signs. It will be used in parallel with the normal equipment the~     study site uses to take and monitor vital signs.~   "
80140|NCT02517970|"~     The objective of the proposed research is to conduct a within-subject experimental study that~     will assess the effect of environmental distractions on a mothers' ability to recognize and~     feed in response to infants' feeding cues. Investigators hypothesize that mothers will spend~     significantly more time looking at their technology compared to looking at their infant,~     which will be negatively associated with the mothers' responsiveness to her infant. This will~     have a positive association with infant intake during the feeding. Investigators also~     hypothesize that mothers will show less sensitivity when distracted when compared to when~     they are not distracted.~   "
80131|NCT02518087|"~     Our project intends to reduce cardiac surgery associated - acute kidney injury (CS-AKI) in~     non emergent patients with the use of an increased adsorption membrane (oXiris®) connected to~     the cardiopulmonary bypass (CPB) circuit, besides evaluating the inflammatory response by~     quantifying inflammatory mediators during and after cardiac surgery with CPB. Our study is a~     randomized and controlled multicentre trial that includes recruiting centres with a long~     experience in cardiac surgery with CPB.~      The primary endpoint of the project is to evaluate the ability of oXiris® to reduce the~     incidence of CS-AKI in patients undergoing non emergent cardiac surgery with an expected CPB~     time of more than 60 minutes (doble valve replacement or valve replacement plus coronary~     artery bypass graft). With the goal of reducing by 10% (from 25 to 15%) the risk of CS-AKI~     during the first postoperative week a sample size of 340 patients has been calculated.~      Secondary endpoints are two; first, to evaluate the effect of using oXiris® on survival,~     clinical course and removal capacity of cytokines and lipopolysaccharide (LPS) during and~     after CPB; and second, to assess the predictive value for CS-AKI of some new biomarkers, such~     as uNAD (urinary nicotinamide adenine dinucleotide).~   "
80132|NCT02518074|"~     The investigators objective is twofold. Investigators propose to study how the vestibular and~     auditory information interact in the construction of coherence between the staff and~     extrapersonal space.~      Furthermore, investigators want to investigate whether, even in the absence of gravity, the~     auditory spatial information allocentric provide a framework for spatial reference.~   "
80133|NCT02518061|"~     This is a retrospective study that involves the revision of clinical, instrumental and~     pathologic data of an estimated cohort of maximum 145 patients with glioma treated with~     surgery with radical intent at our center.~   "
80134|NCT02518048|"~     The purpose of this study is to evaluate the anti-psoriatic effect of LEO 90100 aerosol foam~     compared with Betesil® medicated plaster~   "
80135|NCT02518035|"~     Effort to reduce post-surgical scar is especially important for microtia patients. Even the~     scar lies posterior to ear auricle, but hypertrophic scar contracture may limit the ear~     auricle projection. If the scar is hypertrophic and conspicuous, this stigmata will~     accompanies the child for many years.The main objective aim of this study is to examine~     whether post-operative use of silicone gel can improve scar formation for microtia~     reconstruction scars.~   "
80136|NCT02518022|"~     The purpose of this study is to show that during and after drinking beer a treatment strategy~     by insulin bolus and reduction of basal rate reduces the rate of hyperglycaemia without an~     increase of hypoglycaemic events compared to a treatment strategy according to the standard~     recommendation without insulin Bolus.~   "
80137|NCT02518009|"~     Gender dysphoria (DSM-5) or transsexualism (ICD10) is a condition in which a person's feeling~     of gender identity is not congruent with the physical body. The hormonal treatment includes~     inhibition of one's own sex hormone production followed by treatment with testosterone or~     estrogen levels that are normal for the opposite sex. Seen as experimental model, this is a~     process that provides an opportunity to study the sex hormone dependent influences that~     explain differences in morbidity in men and women respectively. The differences that are~     especially significant but not well known is 1) metabolic changes in the regulation of~     glucose homeostasis and lipid metabolism 2) regulation of vascular function and structural~     effects on the heart and arteries 3) regulation of skeletal muscle mass and fat tissue 4)~     morphological and functional effects on discrete areas of the brain.~      Therefore, the investigators will follow these patients for a year to study how the heart,~     blood vessels, brain, and risk factors for cardiovascular disease affected by altered sex~     hormone patterns and studying what happens in the muscles and fat in both the short and long~     term with respect to particular gene expression and epigenetic changes and link it to~     metabolic changes and body composition.~   "
80138|NCT02517996|"~     Interstitial cystitis/Painful bladder syndrome (IC/PBS) is a chronic debilitating condition~     that severely impacts between 2.7 and 6.5 percent of women in the United States. Despite its~     public health importance the pathogenesis of IC/PBS is not well understood and there is no~     consensus on the optimal treatment approach for this condition. Hydrodistention is the most~     commonly used therapy for this condition; but it is limited by severe immediate postoperative~     bladder pain and its short duration of action. It has been postulated that hydrodistention~     works by disrupting the sensory nerves within the bladder that may be contributing to bladder~     pain. Recent evidence has provided support for the use of preemptive pudendal nerve block as~     a way to blunt immediate postoperative pain. The investigators hypothesize that preemptive~     pudendal nerve block prior to hydrodistention will result in lower postoperative pain after~     hydrodistention compared to placebo. This is a prospective double- blinded randomized study~     and patients will be randomized to receive preemptive bilateral pudendal nerve block with~     either 1% lidocaine or placebo. Bladder pain will be compared at baseline, 2 hours, 2 weeks,~     6 weeks and 3 months using the Visual Analog Scale, O'Leary-Sant questionnaire and the Pelvic~     Pain Urgency and Frequency questionnaire.~   "
80139|NCT02517983|"~     World Health Organization (WHO) considers chronic respiratory disease (CRD) as one of its~     four priorities. These diseases include asthma and rhinitis, chronic obstructive pulmonary~     diseases (COPD), occupational lung diseases, sleep apnoea syndromes, pulmonary hypertension,~     bronchiectasis and interstitial lung diseases. They constitute a serious public health~     problem in all countries throughout the world, in particular in low and middle income~     countries and in deprived populations. Hundreds of millions of people of all ages, in all~     countries of the world, are affected by chronic respiratory diseases. More than 50% of them~     live in low and middle income countries. Over 90% of deaths and the complete inability, due~     to CRDs occur in countries with low or middle incomes.~      The main causes of CRD are: tobacco smoke, occupational factors, indoor air pollution and~     outdoor air pollution, allergens, sequelae of respiratory infections such as tuberculosis.~      More than 30% of the population of Ho Chi Minh City (HCMC) could develop a CRD. In fact, 15%~     of children and 7% of adults could become asthma and 6% of the population could become COPD~     due to smoking. Children exposed to fumes from biomass burning, early in their life, seem to~     have a higher risk to develop COPD. The high level of air pollution in HCMC could aggravate~     asthma / COPD. Populations combining the rural risk (exposure to smoke from biomass) and the~     urban risk (smoking, pollution) may develop COPD much earlier (before age 40). Among the 9~     million people in HCMC, 50% of the population is rural origin. Within this population,~     parasites could play a protective role against the risk of allergic asthma and consequently,~     the better control of helminthiasis among urban population, may result in allergic diseases~     such as asthma and anaphylaxis. Finally, the sequelae of tuberculosis (incidence is~     200/100000) could participate to the morbidity of COPD / CRD.~      Study granted by the ARES-CUD (Comission universitaire au développement)~   "
80143|NCT02517931|"~     This study evaluates sphenopalatine ganglion block (SPGB) for the treatment of postdural~     puncture headache (PDPH) in the emergency department (ED). Half of the patients will receive~     a true nerve block with lidocaine and bupivacaine. The other half will receive a placebo~     nerve block.~   "
80146|NCT02517892|"~     This is a prospective study to identify molecular mechanisms of acquired resistance to~     targeted therapies in patients with unresectable or metastatic cancer.~      This is a protocol to study clinical characteristics and biopsy tissue of patients with~     oncogene-driven cancer who have had previous clinical response to targeted therapy and~     subsequently experience progression of disease. The tissues and other specimens will be used~     to carry out laboratory studies to explore the molecular basis of acquired resistance to~     targeted therapies.~   "
80147|NCT02517879|"~     All households in three zones in Zambia's Eastern Province were invited to attend a community~     point distribution of insecticide treated bed nets (ITNs). Households were then randomized to~     different intervals for a community health worker (CHW) hang-up visit.~   "
80148|NCT02517866|"~     The purpose of this study is to evaluate the efficacy and safety of azilsartan medoxomil~     (AZM) in Asian adult participants with both essential hypertension and type 2 diabetes.~   "
80149|NCT02517853|"~     The aim of this study is to evaluate the efficiency of the Neuroestimulation of the Posterior~     Tibial Nerve for the treatment of this syndrome.~      A multicentric, prospective, randomized study will be performed in patients affected with~     severe LARS symptoms. Patients will be randomized in two groups:~        1. Control group- placebo~        2. Treatment group: neuroestimulation of the posterior tibial nerve~   "
80150|NCT02517840|"~     The rise in life expectancy implies an increased number of nonagenarian patients who need~     evaluation for critical lower limb ischaemia (CLI). The study goal is to evaluate whether~     revascularization techniques in these patients fulfill a set of security and efficacy~     criteria generated from surgical results in a validated historical cohort.~   "
80151|NCT02517827|"~     The endovascular therapy prevailed in nearly all regions of peripheral artery disease over~     open surgery techniques. However, in treatment of the common femoral artery vascular surgery~     is still the gold standard of therapy. One-year patency rates are between 90% and 95%. Today,~     only in selected cases an endovascular procedure for common femoral artery diseases is~     recommended.~      The primary objective of this study is to compare the performance of directional atherectomy~     and drug-coated balloon angioplasty over vascular surgery in common femoral artery lesions in~     a prospective, multi-center, randomized clinical trial.~   "
80152|NCT02517814|"~     Vitamin D deficiency could be a high risk for cardiovascular diseases. It has been recently~     reported that vitamin D deficiency is another cause of heart failure and cardiomyopathies. It~     was found that vitamin D supplementation improved the heart function. The purpose of this~     study is to evaluate patients with idiopathic cardiomyopathies and determine whether vitamin~     D supplementation in cases where there is a deficiency, improves heart functioning.~   "
80153|NCT02517801|"~     Anthocyanins are the most common polyphenols in berries and red wine, along with other~     flavonoids, phenolic acids, minerals and vitamins. Anthocyanins are extensively metabolized~     and they are transformed into glucuronides and phenolic acids. The investigators have~     recently shown that the acute consumption of blueberries leads to an increase in~     endothelium-dependent vasodilation measured as flow-mediated dilatation (FMD) in young male~     volunteers. There were significant correlations of these effects with the plasma~     concentration of phenolic acids and anthocyanin metabolites. Therefore, the present study~     aims at understanding to which extent the anthocyanins contained in berries are related with~     positive effects in endothelial function. A large part of the absorbed anthocyanin circulate~     in the blood in as methyl, glucuronyl and sulfate metabolites, as well as phenolic acids. The~     formation of these metabolites begins right as early as 2h after consumption due to~     metabolism at the small intestine and a second plasmatic peak occurs around 6h due the~     metabolism of colonic bacteria. Whether and which metabolites are associated with biological~     effects and the mechanisms underlying this effect remains unclear.~   "
80154|NCT02517788|"~     Phase I study aiming at:~        -  establishing the pharmacokinetic profile of interferon beta-1a after i.v. administration~          of the formulation BioPartners IFN beta-1a without albumin (HSA-free solution in~          pre-filled syringes) at 18 MIU;~        -  investigating the possible impact of albumin on pharmacokinetic profile by comparing 3~          different i.v. formulations: BioPartners IFN beta-1a without albumin (HSA-free solution~          in pre-filled syringes), BioPartners IFN beta-1a with added albumin (HSA+), and Rebif®~          from Merck-Serono, a registered IFN beta-1a solution containing HSA;~        -  establishing the steady state pharmacokinetic profile of BioPartners IFN beta-1a in~          HSA-free solution after 4 subsequent s.c. doses of 18 MIU given at 48 hour intervals~          against Rebif® using the same regimen.~   "
80155|NCT02517775|"~     Accumulating evidence from epidemiological and human intervention studies indicates that the~     cardiovascular health benefits of diets rich in fruits and vegetables are (in part) related~     to their (poly)phenol content. Cranberries are rich in (poly)phenols compounds, in particular~     anthocyanins, but also phenolic acids. At present, a small number of randomized controlled~     trials investigating the effects of berry (poly)phenols on validated surrogate markers of~     cardiovascular disease risk has shown promising results. However, to date, very few human~     studies have specifically investigated the effects of cranberry (poly)phenols on~     cardiovascular function in healthy subjects. To our knowledge, no study has investigated the~     time and intake-dependent effect of cranberry consumption on vascular function in healthy~     subjects. This information is necessary for the planning of long-term studies aiming to~     assess the potential beneficial effects of cranberries, using optimal amounts at optimal time~     points. Therefore, this study aims to investigate the potential role of cranberry~     (poly)phenols in the modulation of vascular function by monitoring changes in vascular~     function together with the major (poly)phenol derivatives/metabolites in plasma and urine.~   "
80156|NCT02517762|"~     The purpose of this study is to investigate acute low back pain, its origin, mechanisms, the~     cause of pain, evaluation of treatments and development. Employees from a large local~     manufacturing company are sent for a complete orthopedic and pain evaluation immediately~     after onset of acute low back pain. Thereafter, the included patients are allocated either to~     the advice to stay as active as possible in spite of the pain or to adjust their activity to~     the pain. Pain intensity and physical activity are followed prospectively over seven days~     using a diary and a pedometer.~   "
80206|NCT02517086|"~     The objective of this study is to evaluate the effect of elastic compression, functional~     compressive bandaging (ECF) and active exercises in the bloodstream of the upper member~     ipsilateral to the surgical procedure for the treatment of breast cancer.~   "
80157|NCT02517749|"~     This is a multicentre randomised controlled trial evaluating global health related quality of~     life outcomes in patients with malignant pleural effusions. Patients will be randomised to~     receive either chest drain and talc pleurodesis or indwelling pleural catheter and talc~     pleurodesis. Patients will be followed up for 3 months post intervention~   "
80158|NCT02517736|"~     The objective of the study is to determine the efficacy and toxicity of sorafenib in~     metastatic uveal melanoma.~      The main objective is to determine the non-tumor progression rate 24 weeks after initiation~     of treatment with sorafenib at a dose of 800 mg / day~   "
80159|NCT02517723|"~     Narrative Exposure Therapy (NET) is an evidence-based trauma-focussed treatment, suitable for~     survivors of prolonged and repeated exposure to traumatic stress and childhood adversity.~     Patients with Borderline Personality Disorder (BPD) often suffer from a comorbid~     Posttraumatic Stress Disorder (PTSD) caused by multiple traumatic events. Therapeutic aims~     are the reduction of PTSD-Symptoms in these patients via activation of associative neural~     networks related to traumatic experiences and habituation of fear and the placement of~     traumatic experiences in a reconstructed, detailed and consistent autobiography. This~     practice enables the processing of and coping with painful memories and the construction of~     clear contingencies of dangerous and safe conditions, generally leading to significant~     emotional recovery. The investigators assume that using NET the reduction of PTSD symptom~     severity is greater compared to treatment by Dialectical-Behavioral Therapy (DBT).~   "
80160|NCT02517710|"~     Prospective single blinded trial comparing standard synthetic suture material to a synthetic~     barbed suture in closure of uterine incision, during Cesarean section procedures.~   "
80161|NCT02517697|"~     The objective of the study is to investigate effects of inorganic sodium nitrite on the~     cardiometabolic and hormonal disturbances observed in a targeted population of~     overweight/obese adults with metabolic syndrome and hypertension, at risk for insulin~     resistance and endothelial dysfunction.~   "
80162|NCT02517684|"~     The purpose of this study is to determine whether a top-down treatment approach, prescribing~     infliximab (IFX) and azathioprine (AZA) at diagnose, yields better outcome in comparison to~     the usual step-up treatment approach, starting with prednison and AZA or exclusive enteral~     nutrition (EEN) and AZA, in moderate-to-severe pediatric Crohn's disease (CD) patients.~   "
80163|NCT02517671|"~     The purpose of this study is to assess the effects of 35 EECP sessions on cardiopulmonary~     training performance in healthy volunteers. Data from this study will be used to generate~     sample size and power calculations for feasibility of future EECP studies. The results of~     this study could provide evidence that can help active duty and Department of Defense~     beneficiaries optimize physical conditioning, endurance and overall health.~   "
80164|NCT02517658|"~     The study will involve parents filling out a survey before & after watching a teaching tool~     video (https://www.youtube.com/watch?v=rIH63jqvlio) in addition to standard post-op teaching.~     The parents randomized to the video arms will watch the video while their child is in the OR~     and then either take the post survey immediately after or wait to take the survey until just~     prior to discharge. Parents not in the video arms of the study will also be asked to complete~     a survey pre and post standard pain management teaching.~   "
80165|NCT02517632|"~     The aim of this investigation is to evaluate the impact of exercise in a cardiac~     rehabilitation program on functional capacity, clinical markers, quality of life and~     biomarkers in patients with chronic chagasic cardiomyopathy.~   "
80166|NCT02517619|"~     The purpose of this study is to evaluate the safety and efficacy of ocular iontophoresis with~     dexamethasone phosphate ophthalmic solution EGP-437 using the EyeGate® II Drug Delivery~     System (EGDS) compared to prednisolone acetate ophthalmic suspension (1%) in patients with~     non-infectious anterior segment uveitis.~   "
80167|NCT02517606|"~     Chronic nonspecific low back pain is an important health condition with a high prevalence~     worldwide and it is associated with enormous direct and indirect costs to the society.~     Clinical practice guidelines show that many interventions are available to treat patients~     with chronic low back pain, but the vast majority of these interventions have a modest effect~     in reducing pain and disability. A biomechanical approach that has been raised is that a~     weakness of the hip abductors, extensors, and lateral rotators musculature (posterolateral~     complex - PLC) would lead to excessive contralateral pelvic drop during weight-bearing~     activities such as walking, running, climbing up or downstairs, generating an overload in the~     lumbar area. Although the strengthening of the hip PLC is largely used in clinical practice~     for treating patients with hip and knee injuries, there is still a lack of evidence regarding~     patients with low back pain. Therefore, questions remain about the efficacy of the hip~     dynamic stabilization as an additional intervention to conventional treatment in a well~     design trial with statistic power.~   "
80168|NCT02517593|"~     The primary aim of this study is to determine if the addition of an individual polygenic risk~     score (PRS), in addition to the standard National Cancer Institute's Breast Cancer Risk~     Assessment Tool (BCRAT) or Tyrer-Cuzick (IBIS) score, will aid women at risk of breast cancer~     in making a decision to take (or not take) medications to prevent breast cancer~   "
80169|NCT02517580|"~     This study is a single arm, single center clinical trial that aims to evaluate the effect of~     8 weeks of vitamin K2 replacement (360 mcg/day) on the progression of arterial stiffness in~     stable renal transplant patients.~   "
80170|NCT02517567|"~     The purpose of this study is to evaluate the tear film evaporation of symptomatic soft~     contact lens wearers in the absence of contact lens wear and after at least 8 hours of~     contact lens wear.~   "
80171|NCT02517554|"~     The goal of this research is to evaluate the relative advantage of remote counseling over~     usual care in community health practices without access to genetic services. We will evaluate~     ability of remote telemedicine, referred to going forward as TeleGenetic services (phone or~     videoconferencing), to increase uptake of genetic testing and identification of genetic~     carriers compared to usual care. Secondly, we will evaluate the advantages of~     videoconferencing over telephone for delivery of remote genetic services and the short-term~     and longitudinal outcomes of TeleGenetic services in socio-demographically diverse patients~     in community practices.~   "
80172|NCT02517541|"~     The aim of the study is to obtain an understanding of relevant parameters affecting the~     performance of ostomy products.~   "
80173|NCT02517528|"~     This is a Phase 3, open-label, multicenter study evaluating the efficacy and safety of ABT~     450/r/ ABT 267 and ABT-333 coadministered with ribavirin (RBV) for 12 weeks in HCV genotype~     1b, treatment naïve and Interferon (IFN) (alpha, beta or pegIFN) plus RBV~     treatment-experienced Asian adults with compensated cirrhosis.~   "
80174|NCT02517515|"~     This is a study to evaluate ABT 450/r/ABT-267 and ABT-333 in treatment-naïve and~     treatment-experienced Asian adults with subgenotype 1b chronic HCV without cirrhosis.~   "
80175|NCT02517502|"~     The purpose of this study is to determine if a high dose of DHA begun prior to and continued~     during neo-adjuvant chemotherapy (chemotherapy given prior to surgery) is likely to prevent~     or lessen chemotherapy induced cognitive dysfunction.~   "
80176|NCT02517489|"~     Mortality of severe Community-Acquired Pneumonia (CAP) has not declined over time and is~     between 25 and 30% in sub-groups of patients. Corticosteroids (CTx) could down-regulate~     pulmonary and systemic inflammation, accelerate clinical resolution and decrease the rate of~     inflammation-associated systemic complications. Two recent meta-analyses suggest a positive~     effect on severe CAP day 28 survival when CTx are added to standard therapy. However they are~     based on only four trials gathering less than 300 patients, of which only one was positive.~     Recently published guidelines do not recommend CTx as part of CAP treatment. Therefore a~     well-powered trial appears necessary to test the hypothesis that CTx - and more specifically~     hydrocortisone - could improve day 28 survival of critically-ill patients with severe CAP,~     severity being assessed either on a Pulmonary Severity Index ≥ 130 (Fine class V) or by the~     use of mechanical ventilation or high-FiO2 high-flow oxygen therapy.~      A phase-III multicenter add-on randomized controlled double-blind superiority trial assessing~     the efficacy of hydrocortisone vs. placebo on Day 28 all-causes mortality, in addition to~     antibiotics and supportive care, including the correction of hypoxemia.~      Randomization will be stratified on: (i) centers; (ii) use of mechanical ventilation at the~     time of inclusion.~   "
80177|NCT02517476|"~     The aims of the randomized-controlled, multicenter EFFORT trial are to assess the effects of~     early nutritional therapy in regard to effectiveness, safety and costs when applied to the~     heterogenous, polymorbid medical inpatient population. EFFORT will not only answer the~     question about overall benefit or harm, but using a physio-pathological mechanistic approach,~     it also will explore and provide conclusive answers about whether, why, how, and in which~     patient populations nutritional therapy does and does not works.~   "
80178|NCT02517463|"~     This was a prospective, open-label, single-drug, uncontrolled, observational clinical study.~      Women attending the Family Planning Association of Hong Kong (FPAHK) for emergency~     contraception within 120 hours of UPSI were recruited. Subjects were recruited from both the~     Birth Control Clinics and Youth Health Care Centres of the FPAHK.~      Depending on the timing in relation to ovulation in the current menstrual cycle at the time~     of presentation, the women were classified into two groups:~      Group 1: pre-ovulatory Group 2: post-ovulatory~      After counseling and obtaining informed consent, eligible subjects received a single dose of~     ulipristal acetate 30 mg (ellaOne®) under direct supervision. A baseline blood test for~     hormonal profile (LH, oestradiol and progesterone) and ultrasound scan for ovarian follicle~     assessment were carried out by a designated doctor or research nurse at the clinic visit.~      The subjects were advised not to have further acts of coitus before the return of~     menstruation. They were given a diary chart to record vaginal spotting and bleeding, possible~     side effects and further acts of intercourse, if any, and the contraceptive method used. A~     follow-up appointment were be arranged about 1-2 weeks after the expected next menstruation.~     Any events of unplanned pregnancy and adverse effects were recorded for analysis.~   "
80179|NCT02517450|"~     This study tested the effectiveness of an adventure-based training programme in promoting the~     psychological well-being of primary schoolchildren. A randomised controlled trial was~     conducted, with 56 primary school pupils randomly assigned to the experimental group~     participating in the adventure-based training programme and 64 to the attention placebo~     control group.~   "
80180|NCT02517437|"~     The purpose of this study is to determine whether the combination of suprascapular and~     axillary nerve blocks is non-inferior to the conventional interscalene block (ISB) in~     providing pain relief during the first postoperative day to adult healthy patients (age > 18)~     undergoing ambulatory shoulder surgery.~   "
80181|NCT02517424|"~     The purpose of this study is to evaluate the safety and efficacy of vaporized cannabis in~     participants with chronic, treatment-resistant posttraumatic stress disorder.~   "
80182|NCT02517411|"~     Chronic Obstructive Pulmonary Disease (COPD) is a lung disease that is characterized by~     incompletely reversible airflow obstruction. It is projected to be the fifth leading burden~     of disease worldwide by the year 2020. Pulmonary dysfunction reduces exercise capacity in~     COPD patients, and it has been previously shown that COPD patients suffer deterioration in~     their quality of life. The objective of this study is to examine the effects of a physical~     therapy intervention in stable patients with COPD.~   "
80183|NCT02517398|"~     The main purpose of this Phase I study is to test MSB0011359C (M7824) at different dose~     levels to see if it is safe and well tolerated when given once every 2 weeks. Phase I means~     the study drug has not previously been given to humans or has only been given to a limited~     number of people, although it has been extensively studied in animals. Based on this~     information, it is hoped to find out which dose could be best for the treatment of patients.~     There are two parts of this research study: a dose-escalation part and an expansion part.~     Dose escalation means that the first people taking part in the study will receive low doses~     of the study drug, and as more people take part, the additional participants will receive a~     higher dose. This is done to find the safest dose for the study drug. Expansion means that~     after the dose-escalation part of the study has looked at the safety and effectiveness of~     different doses, many more people will be invited to take part in the study and will receive~     the study drug at the safest dose. Additional purposes of the study are to find out whether~     the study drug has anti-cancer effects and how the study drug is processed by the body.~   "
80184|NCT02517385|"~     Primary Objective:~      To assess safety of Phosphatidylcholine paste 600 mg (ESSENTIALE® paste) oral 3 times a day~     for 12 weeks in patients with gastrointestinal symptoms in acute and chronic liver diseases.~      Secondary Objectives:~      To assess effectiveness on symptomatic improvement in patients with gastrointestinal symptoms~     in acute and chronic liver diseases.~      To monitor compliance.~   "
80185|NCT02517372|"~     This study is a single-centre, open-label, dose escalation , safety, tolerability and~     pharmacokinetics (PK) study in healthy male and female subjects. The study include a~     screening day and a 5-day dosing period. Subjects will be enrolled in sequential cohorts and~     each cohort will include 8 subjects. there will be 24 subjects total included in the study.~     The duration of the clinical part of the study will be approximately 2 months.~   "
80186|NCT02517359|"~     RV6153 is a new medicine being developed for possible treatment of asthma and smoking related~     lung disease (also known as chronic obstructive pulmonary disease - COPD).~      The main purpose of this study is to investigate the safety, tolerability, pharmacokinetics~     and pharmacodynamics of single and repeat doses of RV6153~   "
80187|NCT02517346|"~     The purpose of this study is to compare the effectiveness of telemonitoring versus standard~     follow-up on CPAP treatment compliance in Obstructive Sleep Apnea Syndrome (OSAS).~   "
80188|NCT02517333|"~     The importance of play and physical activity include its many benefits on positively~     improving health and well-being, enhancing children's and young people's thinking and~     performance in school, improving their sleep and enabling confidence and skill building~     (Janssen and LeBlanc, 2010; Budde et al., 2008; Sallis and Patrick, 1994). However, children~     with movement difficulties (MD) and physical disabilities are at risk of decreased physical~     activity and subsequently decreased physical fitness and overall health and well-being as a~     result. To build upon current findings and to follow-up on a continuing study, looking at the~     impact (responses) and recovery during and following acute exercise at different intensities~     in children and adolescents with and without movement difficulties, this next phase aims to~     provide an intervention to improve fitness levels and health measures and to strategically~     provide a pathway for longer term participation in physical activity in young people.~     Implement and evaluate a pathway to sport for 14+ year old young people who do not regularly~     participate in sport due to Neurodevelopmental conditions, young people presenting with poor~     coordination and movement, and even children and adolescents with special educational needs.~     The pathway hopes to promote engagement, participation, inclusion and confidence (EPIC) in~     sport within local schools and the community through 1) targeted recruitment, 2) confidence~     and skill building (EPIC Club), 3) connection to sport ('Have a go days') and 4) exit to long~     term participation.~   "
80189|NCT02517320|"~     The purpose of this study is to evaluate the efficacy of MT-3995 in subjects with diabetic~     nephropathy, compared with placebo, using urine albumin- to-creatinine ratio (UACR) in the~     first morning void urine sample as an indicator.~   "
80190|NCT02517307|"~     The purpose of this study is to learn more about what causes insulin resistance. It has been~     suggested that proper breakdown of fat into energy (oxidation) in the body is important to~     allow insulin to keep blood sugar in the normal range. The investigators want to know if~     having one of the fatty acid oxidation disorders could have an influence on insulin action.~     Fatty acid oxidation disorders are genetic disorders that inhibit one of the enzymes that~     converts fat into energy. The investigators will study both normal healthy people and people~     with a long-chain fatty acid oxidation disorder.~   "
80191|NCT02517294|"~     Comparison is made between standard nasotracheal tubes and a specially designed nasotracheal~     tube during nasotracheal intubation in children undergoing general anesthesia for dental~     surgery.~   "
80192|NCT02517281|"~     The aim of the study is to do a descriptive analysis of the cutaneous toxicity observed in~     patients treated using targeted therapies in order to have a better understanding of the skin~     pathophysiology.~   "
80193|NCT02517268|"~     This randomized clinical trial studies accelerated recovery pathway for discharge after~     surgery in patients with pancreatic cancer. A standardized accelerated recovery pathway may~     improve outcomes after surgery following complex abdominal operations resulting in a shorter~     length of stay in patients with pancreatic cancer. It may also help patients to mobilize more~     quickly and return to the home setting, decrease hospital-acquired infectious complications,~     and increase potential cost savings. It is not yet known whether an accelerated recovery~     pathway is better than a standard recovery pathway for discharge following surgery in~     patients with pancreatic cancer.~   "
80194|NCT02517255|"~     Atherosclerotic disease is responsible for one third of all deaths annually and is a major~     cause of comorbidities. While atherosclerosis is by itself a benign disease, it often leads~     to complications such as acute myocardial infarction with ST-segment elevation. Rescue~     angioplasty is indicated if thrombolytic therapy fails. However, the benefits in reducing~     mortality and the amount of myocardium effectively saved are not well established. The~     development of new tools, including cardiac magnetic resonance imaging to identify myocardial~     area at risk and infarcted increased diagnostic accuracy. However, unlike the context of~     primary angioplasty, little is known about the relation between coronary epicardial and~     microvascular flow after rescue angioplasty and myocardial salvage. The objective of this~     study is to evaluate whether there is a relation between these flows and myocardial salvage~     identified by Magnetic Resonance Imaging (MRI). At the end of this research, the~     investigators hope to contribute to a better understanding of coronary flow and its relation~     to the amount of heart muscle saved after rescue angioplasty. This is an important~     information that can help understand which cases benefit most from rescue angioplasty.~   "
80195|NCT02517242|"~     This is a prospective, intervention, randomized, phase IV study. Patients will be included~     with 60 years or older, both sexes, with HbA1c >8.5% using oral antidiabetics agents and~     insulin and then we will be randomized by use syringe or pens device to use insulin NPH and~     regular. All patients will receive a blood glucose monitor, lancet tapes, capillary blood~     glucose tests (3 tests/day). HbA1c will be measured at baseline, 3 and 6 months. Patients~     will see monthly.~   "
80196|NCT02517229|"~     The scientific goal of this experiment is to evaluate changes in balance control in response~     to microgravity during reactive balance tasks. For that purpose, kinematic and neuromuscular~     parameters under microgravity are compared to normal gravity conditions. To induce postural~     responses among the test subjects, an electromagnetic maneuverable postural platform will be~     used in order to randomly elicit perturbations. Postural reactions will be quantified by~     means of mechanical and electromyographic data. In Addition, peripheral nerve stimulation~     will be used to assess the spinal excitability by means of H-reflex recordings. H-reflex~     measurements were chosen as they allow reliable information about inhibitory and facilitatory~     mechanisms taking place at the spinal level.~   "
80197|NCT02517216|"~     Weightlessness profoundly modifies many physiological systems and especially the nervous~     system and the vestibular system. The changes in the nervous system are based in part on~     brain plasticity mechanisms, that is to say on modifications of neurons and their~     connections. They are the source of some of the behavioral response observed in the parabolic~     flight or in astronauts. For example, it is commonly observed that in the second and third~     days of parabolic flight campaigns with 3 flights, fewer participants are prone to motion~     sickness during the first day. Similarly, during their first trip into space, astronauts~     suffer 2/3 for 2 or 3 days of space sickness - special form of motion sickness - while this~     proportion is much lower in the second trip.~      The hypothesis of this study is that short-term weightlessness as well as changes in the~     level of gravity experienced during parabolic flights, induce neuroplascity phenomena in~     brain regions involved in the integration of vestibular, visual and proprioceptive.~      The goal is to objectify these plasticity phenomena, and assess their changes over time,~     using methods of Magnetic Resonance Imaging (MRI). A standard MRI will give an anatomical~     image of the brain. For this study, a variant called diffusion MRI (Diffusion Tensor Imaging~     - DTI) will visualize nerve bundles and their journey in the brain. The total duration of~     this review will be about ¾ hour.~      The results of this study will be compared with those of an ongoing study of 12 astronauts~     who have the same MRI scans taken before and after a trip to the International Space Station.~     Investigators can then evaluate the effect of duration of exposure to weightlessness on the~     phenomena of neuroplasticity.~   "
80198|NCT02517190|"~     From previous parabolic flight campaigns completed by our research group investigators~     gathered data showing important changes in neuro‐endocrine and also immunological changes.~     This experiment now will complete the data set‐up obtained during the MARS500 study on how~     these respective individuals will re‐act to highly physically and emotionally challenging~     situations during a parabolic flight.~      This add‐on experiment to MARS500 will enable answering to the following questions i) if the~     stress response systems - when compared for two conditions but in the same individuals - do~     react uniformly and ii) if those subjects prone to have adequate stress response pattern will~     show gradually less immune modulation effects.~      The understanding of the complex interactions of stress and immunity under chronic and acute~     stress conditions might help to enable adequate health and immune monitoring and might as~     well suggest suitable countermeasures for the prevention of the unwanted immunological~     effects during long‐term confinement and space missions.~   "
80199|NCT02517177|"~     As a direct consequence of exposure to microgravity, astronauts experience a number of~     physiological changes which can lead to serious medical implications. Most immediate and~     significant is the headward shift of body fluids and the removal of gravitational loading~     from bone and muscles, resulting in progressive changes of the cardiovascular and~     musculoskeletal systems. The cardiovascular systems is subject to rapid changes which has~     been demonstrated in studies of short term (shuttle) and long term missions to Skylab and~     MIR.~      Our main hypothesis is that there is a linear relationship between the gravity level (0G,~     0.16G, 0.38G, 1G, 1.8G) and the cardiovascular parameters (heart rate (HR), heart rate~     variability (HRV), blood pressure and blood pressure variability (BPV) as well the spectral~     analysis of HRV and BPV.~   "
80200|NCT02517164|"~     Every year, nearly 30% of people aged over 65 fall at least once and about 15% fall at least~     twice. These falls can have serious consequences that are a significant threat to the~     independence and well-being of older people. From an economic perspective, the cost of~     medical care related to falls and resulting injuries is very high and continue to grow with~     the aging of the population. Therefore falls prevention is a public health priority.~      Many data suggest that cognitive, common disorders in the elderly, is a major risk factor for~     falls and the elderly often have difficulty managing their parallel postural stability and~     other situations requiring attentional resources. Furthermore, the data used to evoke a role~     of vitamin D in the risk of falls in the elderly. Indeed, vitamin D has beneficial effects on~     muscle and on the human brain and several recent studies have shown the existence of positive~     relationship between serum 25 hydroxyvitamin D and cognitive function. These different~     actions may explain the beneficial effect of vitamin D supplementation on the risk of falling~     for practicing daily oral doses of vitamin D in the range of 700-1000 IU.~      Our goal in this study is to confirm the existence of a link between vitamin D status and~     some areas of cognitive functions, and analyze the roles played by vitamin D deficiency and~     cognitive impairment in the occurrence of falls. The study will also seek the existence of a~     threshold level of 25-hydroxyvitamin D below which may arise cognitive disorders. The~     prospective follow-up of patients for 2 years will study the effect of correcting the vitamin~     D deficiency (initial correction and regular supplementation) on cognitive function, balance,~     walking and the occurrence of falls.~      The study will be conducted in 150 subjects aged 50 years and over and fell in 150 subjects~     aged 50 and over at risk of falling. These patients will be enrolled in the Emergency~     Services, Orthopedics, Geriatrics, and Rheumatology of the University Hospital of Caen. All~     subjects will receive a dose of 25 hydroxyvitamin D, a comprehensive study of cognitive~     function, tests of balance and walking and assessment of activities of daily living and~     depression. All the examinations and tests will be carried out during the same half day.~     According to current recommendations, it will be prescribed a treatment with Vitamin D to~     subjects with a lowered rate of 25 hydroxyvitamin D (<30 ng / ml) to normalize the rate and~     will be advised doctors to prescribe regular supplementation vitamin D in order to maintain~     it in the standard rate (30 to 80 ng / ml). The effect of the correction of hypovitaminosis~     D, confirmed by controlling the rate of 25 hydroxyvitamin D, on cognitive functions, balance~     and walking will be analyzed 3 months and 9 months. During the two years following their~     inclusion in the study, subjects will be contacted by a phone call every 3 months during~     which will be recorded any falls they have been victims, as well as changes to their drug~     treatments, particularly case of regular intake of vitamin D supplementation.~      If our hypothesis were true, it would be appropriate to consider a new approach to prevention~     of fractures involving the correction of vitamin D deficiency, cognitive rehabilitation and~     cognitive-motor drive in subjects with cognitive impairment.~   "
80201|NCT02517151|"~     A phase 2, randomized, placebo controlled trial evaluating the effects of n intravenous iron~     supplementation on chronic fatigue in IBD patients with controlled disease.~   "
80202|NCT02517138|"~     The goal of this study is to objectively determine the perceived direction of the right-front~     by the subjects in weightlessness. The direction of the right-front has not been investigated~     to date with the measurements of the position of the eyes. The investigators will compare the~     intersection of the horizontal and vertical saccadic trajectories (jerky) with the apparent~     direction of the right-front indicated by the subjects when they look right front in the dark~     (LOOK) and that they indicate when they determine whether a visual target through the~     right-front apparent (PERCEPTION). Then, the investigators will compare these measurements~     between normal gravity and microgravity hypergravity during parabolic flight.~   "
80203|NCT02517125|"~     Head and Neck cancers are treated either with surgical resection followed by adjuvant~     radiotherapy, or with organ preservation strategies using definitive radiotherapy with or~     without concomitant chemotherapy. These treatments have long-time functional side effects and~     consequences on the quality of life. Transoral robotic surgery has been developing since 2006~     by Weinstein and O'Malley in alternative to open surgery, to decrease the morbidity of the~     large surgical approach. The da Vinci device had the FDA approval and the CE mark in 2009 for~     transoral surgery of head and neck cancers, using previous generations of da Vinci. The last~     generation da Vinci Xi has received the FDA approval for laparoscopic surgery in april 2014~     and the CE mark in june 2014 but has not been evaluated yet in transoral surgery. The~     objective of our study is therefore to study the feasibility of this transoral robotic~     surgery for head and neck cancers, using the da Vinci Xi.~   "
80204|NCT02517112|"~     3-D Ballistocardiography (BCG) recording was performed in microgravity during the Spacelab D2~     missions on a single astronaut. The results from this experiment have been published in the~     literature: the influence of respiration have been demonstrated and the signal processing~     methodology for the reconstruction of the displacement in one cardiac cycle have been~     developed. A 3D-BCG sensor has been developed and a collaboration to perform a sustained~     microgravity experiment onboard the Russian segment of ISS has been initiated. To be~     integrated in the PNEUMOCARD device, this new sensor needs to be tested in microgravity~     before implemented on ISS.~      The aim of the present parabolic flight study is to serve as a feasibility demonstrator and~     test bed in order to evaluate the feasibility of 3D-BCG in sustained microgravity and to test~     whether the sensitivity of the developed 3D-BCG sensor is appropriate~   "
80205|NCT02517099|"~     This is a single-centre, randomised-controlled trial, comparing management of preschool~     wheeze. It specifically aims to compare management of preschool wheeze using current clinical~     guidelines to management determined by eosinophilic inflammation and infection. Participants~     will be children aged 1-5 years who have recurrent wheezing and will be allocated to one of~     two treatment groups, either current clinical care or pathological phenotype based~     management. They will be asked to make 2 study visits to the Royal Brompton Hospital over the~     course of 4 months.~   "
80207|NCT02517073|"~     The mechanical ventilation strategy has changed over years worldwide. Several international~     researches have been conducted to study the association of the use of mechanical ventilation~     with clinical outcomes. In this prospective, multicenter, cross-sectional survey, the~     practice of mechanical ventilation among patients with severe brain injury will be~     investigated in 70 intensive care units in China.~   "
80208|NCT02517060|"~     The investigators measure brain responses of healthy participants while they perform~     evaluation tasks inside the fMRI. For each task the participants were primed with tactile~     stimuli. Results should demonstrate engagement of sensorimotor brain regions after priming,~     hence confirming embodiment theories.~   "
80209|NCT02517047|"~     Background: Pediatric asthma is the most common chronic illness among children and is~     associated with poor quality of life, activity restriction, school absences, and thousands of~     physician visits annually. The purpose of this study is to measure the effectiveness of using~     an innovative tracking system (CareTRx) for the self-management of asthma, including daily~     and rescue medication use, among children and adolescents with pediatric asthma.~   "
80210|NCT02517034|"~     This randomized clinical trial studies a geriatric assessment intervention in predicting~     chemotherapy toxicity and vulnerabilities (or weakness) in older patients with cancer.~     Assessing patients' functional status, comorbidities, psychological state, social support,~     nutritional status, and cognitive function before treatment may help identify~     vulnerabilities, improve care, and decrease chemotherapy side effects in older patients with~     cancer.~   "
80211|NCT02517021|"~     NEPA-15-18 is a clinical study assessing safety of pro-netupitant and palonosetron, two~     antiemetic drugs, given with oral dexamethasone. The objective of the study is to evaluate if~     pro-netupitant and palonosetron are safe when administered to prevent nausea and vomiting~     after administration of repeated cycles of chemotherapy.~   "
80212|NCT02517008|"~     This study measured the impact and cost-effectiveness of a low-cost, non-monetary incentive~     (mama kit) on rural facility delivery rates in Zambia.~   "
80213|NCT02516995|"~     Merge the data of ultrasound with that of the anatomical and functional MRI is necessary~     since the high dose rate Curietherapy is carried out under ultrasound guidance. The~     investigators will recruit prostate cancer patients to evaluate the quality of the data,~     their sensitivity to exam conditions (patient position, volume of endorectal probe, gold~     grains implanted before intensity modulated radiotherapy , IMRT) and to merge data from~     different sources with the purpose of estimating the opportunities of integration treatment~     plan for Curietherapy broadband.~      The nuclear magnetic resonance imaging provides precise anatomical study, but also provides~     access to a functional approach to the tumor mapping of water diffusion coefficient (DW-MRI),~     for dynamic imaging with injection contrast agent (DCE-MRI) and finally by spectroscopic~     imaging (IRMS). This multimodality imaging project is part of a multidisciplinary context,~     involving close collaboration between clinicians, medical physicists, and physicists of the~     teams participating in this project (Institut Gustave Roussy and U2R2M-CIERM hospital~     Kremlin-Bicetre).~   "
80214|NCT02516982|"~     The aim of this study is to determine the feasibility of using mobile technology for:~        1. Implementing the recommendations of the Antenatal and postnatal mental health: clinical~          management and service guidance NICE guideline for recognising depression (i.e., Whooley~          questions followed by a validated screening instrument such as the Edinburgh Postnatal~          Depression Scale) during pregnancy using iPad Air tablets in the waiting area of general~          practices, midwifery services, or hospitals during antenatal clinics; and~        2. Using a bespoke app running on pregnant women's own smartphones to monitor mood and~          symptoms of depression throughout pregnancy.~   "
80215|NCT02516969|"~     Comparison of 1-year local control in patients with operable, recurrent previously-irradiated~     squamous cell head-and-neck cancers with or without adjuvant SBRT.~   "
80216|NCT02516956|"~     This project aims to demonstrate that the best breakfast meal is the one able to improve the~     best postprandial hunger, satiety and adiposity regulators profile as well as the best~     reward-related gratification, due to hedonistic parameters. To do this, 4 different~     breakfasts will be tested and blood tests, food choices, and attentional components will be~     analysed.~   "
80217|NCT02516943|"~     Blood gas analysis were routinely monitor every 4 hours in our surgical cardiac intensive~     care unit (SICU). These luxury investigations waste the resources. Therefore we develop a~     pathological- based guideline for arterial blood gas analysis in patients after cardiac~     surgery. We test the guideline for its safety and efficacy.~   "
80218|NCT02516930|"~     This is a pragmatic, non-inferiority, randomized controlled trial comparing the effectiveness~     of two methods (crowdsourcing versus social marketing) for creating one-minute videos~     promoting condom use among MSM and TG in China. Crowdsourcing is the process of shifting~     individual tasks to a large group, often involving open contests and enabled through~     multisectoral partnerships.~   "
80219|NCT02516917|"~     This study aims to investigate the application of the Attention Training Technique in~     children with ADHD aged 7-11 years old. The research aims to investigate both the feasibility~     of this technique in this population as well as whether it can improve symptoms, behaviour~     and executive functioning.~   "
80220|NCT02516904|"~     A single ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of~     CD101 IV~   "
80221|NCT02516891|"~     The aims of this study are: 1) To identify more resistant the guidewire type to the retrieval~     maneuvers after the jailing.~      2) To determined anatomic and technical factors influencing the induced damage in the~     guidewire.~      Design of the study: prospective randomized study to compare 2 types of guidewire:~     hydrophilic and no hydrophilic. Patients and methods: Two hundred patients with bifurcation~     coronary lesions will be included. All of then will be treated by provisional side-branch~     stenting using the jailed wire technique. One hundred patients will be randomized to~     hydrophilic wires and another 100 patients to non-hydrophilic wires.~   "
80222|NCT02516878|"~     In this study, a 18-week, single-blinded, randomized controlled clinical trial will be~     conducted to evaluate the effectiveness, efficacy and safety of acupuncture on weight control~     in Hong Kong.~   "
80223|NCT02516865|"~     This project aims to test the feasibility of a practical physical activity intervention for~     postpartum women, incorporating the use of body weights worn during typical daily activities.~   "
80224|NCT02516852|"~     Animal source foods (ASF), such as meat and eggs, are rich in nutrients critical for growth~     and development. Yet, for poor children in developing countries, ASF consumption is limited~     by cost, inadequate caregiver knowledge, and lack of local production and physical~     availability. The impact of HH- and village-level livestock interventions on household~     dietary diversity and nutritional status in resource-poor communities is not well~     established. The objective of this study is to test the effectiveness of local egg production~     intervention on maternal and child diets and child nutrition status.~      This project takes place in the Luangwa Valley, Zambia in partnership with a local~     non-governmental organization, COMACO. Twenty communities will be assigned to the~     intervention, and 20 matched communities will be selected as controls. In each intervention~     community, an egg production facility will be built, owned, and operated by trained COMACO~     farmers.~      Households (HHs) in each community will be sampled twice annually for 1 year pre-intervention~     (baseline) and 1 year post-intervention to assess dietary diversity and nutritional status.~     Data analysis will test for a change in these outcomes from baseline in each intervention~     community compared to the matched control community.~   "
80225|NCT02516839|"~     The objective of this proposed study is to collect initial efficacy data on ROC and ROC + BWL~     compared to an active comparator (AC) and to BWL.~   "
80226|NCT02516826|"~     1. Stains have demonstrated consistent benefits to reduce cardiovascular events in several~          primary and secondary prevention trials. The suppression of plaque progression or~          regression may be a part of mechanism of clinical benefit. The intravascular ultrasound~          studies demonstrated that intensive statin therapy can regress or inhibit the~          progression of coronary atherosclerosis.~        2. Unregulated renin-angiotensin system is important in the pathogenesis of cardiovascular~          disease. Angiotensin receptor antagonists (ARB) have been reported to improve clinical~          outcomes in patients with heart failure, left ventricular dysfunction, myocardial~          infarction, and high-risk patients. Several small studies showed that ARBs were~          effective to inhibit the progression of coronary atherosclerosis by intravascular~          ultrasound examination.~        3. The combined therapy with statins and ARBs may be additive or synergistic effects on the~          atherosclerosis regression as well as to improve endothelial dysfunction and insulin~          resistance in addition to lowering cholesterol levels and blood pressure when compared~          with either monotherapy in patients.~        4. Serial computed tomography angiography (CTA) can be utilized to assess the effect of~          treatment on coronary plaque morphology. In addition to the assessment of luminal~          stenosis, CTA also allows characterization of plaque morphology.~   "
80227|NCT02516813|"~     MSC2490484A or M3814 is an investigational drug that is being evaluated for the treatment of~     subjects with locally advanced tumors. The main purposes of this study are to determine the~     safety, the tolerability and the efficacy of MSC2490484A in combination with radiotherapy and~     in combination with chemoradiotherapy (Radiotherapy + cisplatin).~   "
80228|NCT02516800|"~     Mutations in the SLC34A2 gene, that encodes the sodium phosphate co-transporter (NaPi-IIb),~     cause defect cell-uptake of phosphate, which leads to formation of calcium-phosphate~     concretions in the lungs as seen in Pulmonary Alveolar Microlithiasis (PAM). Extra pulmonary~     calcifications, including heart valve calcification, have previously been reported in~     patients with PAM.~      Calcific Aortic Valve Disease (CAVD) is a common disease in the elderly and is characterised~     by thickening and calcification of the aortic valve leaflets in the absence of rheumatic~     heart disease. CAVD is present in more than 25% of patients older than age 65 years and is~     associated with an increased risk of cardiovascular events. Currently, there is no effective~     therapy for the disease other than surgical aortic valve replacement. Both calcium and~     phosphate are the major components of calcific deposits in PAM and CAVD. Based on these~     preliminary findings, the investigators hypothesize that mutations in sodium phosphate~     co-transporters may play a role in both pulmonary and extra pulmonary calcifications.~      Two studies will be performed: 1. A retrospective cross-sectional study including patients~     with an age ≤ 65 years with CAVD from Denmark and Örebro, will be carried out. Genetic~     association analysis will be performed to investigate the incidence of common variants in~     five genes representing sodium phosphate co-transporters (SLC34A1, SLC34A2, SLC34A3, SLC20A1,~     SLC20A2) compared to healthy controls. Associated genes will subsequently be sequenced to~     identify possible causal mutations. 2. In a prospective study, aortic valve tissue will be~     collected from patients with AS undergoing surgical valve replacement. Molecular~     characterisation of the transporters will be conducted by determining the level of specific~     mRNA and protein by RT-PCR/qPCR, and Western Blotting, respectively. The localisation and~     visualisation will be investigated by immunostaining and confocal laser microscopy.~     Fibroblasts and endothelial cells will be isolated and grown in cultures with subsequent~     functional studies of the phosphate uptake.~   "
80229|NCT02516787|"~     Alongside a well-known physiological deconditioning, such as a decrease in muscle mass or~     bone demineralization, extended stays in weightlessness also cause cognitive dysfunction.~     However, the studies on this subject during space missions short or long term could not~     determine how these cognitive dysfunction resulted from a direct effect of weightlessness or~     a stress-related effect.~      Analysis of electro-encephalography (EEG) using a standardized mapping method is used to~     study the changes of operation of the cerebral cortex as the near infrared spectroscopy~     (NIRS) is a reflection of changes in the cerebral hemodynamics. Their combined use is a~     relatively simple and economical method for studying brain changes in an environment where~     the normal brain imaging techniques can not be used.~      The main objective of this experiment is to evaluate the alterations in brain cortical~     activity and brain oxygenation level induced by micro- and hypergravity conditions.~   "
80230|NCT02516774|"~     The hypothesis is that the particular richness of ATC's microenvironment in TAMs creates a~     unique opportunity for using Tumor Necrosis Factor blockade during chemotherapy and~     radiotherapy in order to counteract tumor resistance to therapy.~   "
80231|NCT02516761|"~     The idea of this study is the combination of these two techniques (low-impact aerobic~     exercise through functional movements and music therapy) that have proven to be effective~     separately. The main objective of this study is to test this combination to reduce widespread~     pain in fibromyalgia patients, improve their balance, influence on decreasing levels of~     depression and improve quality of life.~   "
80232|NCT02516748|"~     Accurate optical diagnosis of colorectal polyps could allow a resect and discard strategy~     with surveillance intervals determined based on the results of the optical biopsy. The~     investigators perform education to characterize the histology of diminutive and small~     colorectal polyps by using narrow band imaging (NBI). After education program, the~     investigators prospectively evaluate real-time optical biopsy analysis of polyps with NBI by~     15 gastroenterologists at a medical check up center.~   "
80233|NCT02516735|"~     The purpose of this study is to assess whether i-scan with magnification can reduce the~     biopsy number needed per patient for the detection of gastric intestinal metaplasia without~     the loss of corresponding diagnostic yield.~   "
80234|NCT02516722|"~     The objective of this study is to assess the safety, performance and initial effectiveness of~     the TIVUS™ System when used for pulmonary artery denervation through subjective and objective~     change in clinical parameters and haemodynamic evaluation. This is a prospective,~     multi-center, non-randomized, open-label clinical trail. The study will be conducted in up to~     5 centers and will recruit up to 15 patients diagnosed with PAH, functional class III who~     have stable PAH on a stable drug regimen of two pulmonary arterial hypertension specific~     medications.~   "
80235|NCT02516709|"~     Ongoing follow up for subjects implanted with the Linear Source String for prostate cancer.~   "
80236|NCT02516696|"~     This is a randomized, open-label, phase III study to investigate the efficacy of combination~     therapy with an induction phase utilizing a combination clarithromycin (Biaxin®),~     lenalidomide (Revlimid®), dexamethasone (Decadron®), in multiple myeloma patients who are~     newly diagnosed and require treatment when compared to patients who receive lenalidomide and~     dexamethasone alone.~   "
80237|NCT02516683|"~     Background: The incidence of postinfectious irritable bowel syndrome (PI-IBS) was reported to~     be in the range of 5-30%, but limited number of long-term follow-up results.~      Objective: To investigate the long term clinical course of PI-IBS after Shigellosis.~      Setting: A Shigellosis outbreak in a tertiary referral hospital with about 2,000 employees in~     Korea at 2001.~      Patients: A Shigella-exposed cohort of 124 hospital employees who had been infected by~     Shigella sonnei due to contaminated food in the employee-cafeteria in Gangnam Severance~     Hospital, Seoul, Korea, at December 2001. A control cohort of age and sex-matched,~     non-infected 105 contemporary hospital employees.~      Measurements: Questionnaire survey for bowel symptoms at 1, 3, 5, 8 and 10 years after~     outbreak.~   "
80238|NCT02516670|"~     This randomized phase II trial studies how well docetaxel works when given with or without~     ascorbic acid in treating patients with prostate cancer that has spread to other places in~     the body. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Ascorbic acid (vitamin C) is a water-soluble vitamin that may~     help inhibit the growth of cancer cells. It is not yet known whether docetaxel works better~     when given with or without ascorbic acid in treating prostate cancer.~   "
80239|NCT02516657|"~     The purpose of this study is to study the effect of a liraglutide, a glucagon-like peptide~     agonist, on post-meal blood glucose concentrations, glucagon levels, mean weekly blood~     sugars, and insulin doses in adolescents with Type 1 diabetes. Type 1 diabetes is an~     autoimmune disease that is usually diagnosed before the age of 20. Individuals with this~     disease are completely dependent on insulin for survival. While significant advances have~     been made in technological support for improving diabetes control, insulin remains the only~     effective treatment for Type 1 diabetes. Liraglutide is a long-acting glucagon-like peptide-1~     analog. This drug is approved for the treatment of Type 2 diabetes in adults. This study will~     test the effect of liraglutide on blood sugar control in adolescents with Type 1 diabetes.~   "
80240|NCT02516644|"~     The primary hypothesis of the investigators is that a virtual reality system combined with~     physical activity provided on a body weight support treadmill training would change clinical~     parameters of balance and mobility in people with Parkinson's Disease~   "
80241|NCT02516631|"~     The purpose of this study is to compare pharmacokinetics of two formulations of misoprostol~     following single dose administration in adult women being given misoprostol for cervical~     ripening and induction of labour.~   "
80242|NCT02516618|"~     The primary objective of the study is to assess the safety and tolerability of a single dose~     of subcutaneous (SC) or intravenous (IV) administered fasinumab in healthy Japanese subjects.~   "
80243|NCT02516605|"~     A multi-part study to assess safety, tolerability and efficacy of tropifexor (LJN452) in~     patients with primary biliary cholangitis~   "
80244|NCT02516592|"~     This study will investigate whether switching symptomatic COPD patients from a fixed-dose~     combination of salmeterol/fluticasone 50/500 µg b.i.d. to a fixed dose combination of QVA149~     110/50 µg o.d. leads to improved lung function and airflow. It will also assess the effect on~     symptom burden, breathlessness, and use of rescue medication after this switch.~   "
80245|NCT02516579|"~     In the context of the Risk Management Plan (RMP), as requested from Addmedica by the EMEA, to~     collect information about long-term safety of Siklos® (hydroxycarbamide) when used in current~     practices for the prevention of symptomatic vaso-occlusive complications in patients with~     Sickle Cell Disease.~   "
80246|NCT02516566|"~     The investigators aim to investigate the effects of positive end-expiratory pressure~     ventilation on intracranial pressure assessed by sonographic optic nerve sheath diameter in~     patients undergoing robot-assisted laparoscopic prostatectomy.~   "
80247|NCT02516553|"~     The aim of the phase Ia (dose escalation) part of this trial is to assess the Maximum~     Tolerated Dose (MTD) of BI 894999 administered at escalating doses in two treatment schedules~     (schedule A of continuous dosing, schedule B with two weeks on treatment followed by one week~     off in 3-week cycles) in patients with solid tumours. In the phase Ib expansion part, the aim~     is to further evaluate the safety profile of BI 894999 at the recommended dose and schedule~     in patients with solid tumours and to assess target modulation and the potential antitumour~     efficacy in patients with selected types of tumours. Once the MTD has been determined for~     both schedules in patients with solid tumours, the MTD will be determined as well in patients~     with diffuse large B-cell lymphoma (DLBCL), using the recommended schedule for solid~     tumours.The PK profile will be determined from the first cycle in all patients in both~     phases.~   "
80248|NCT02516540|"~     The hypothesis of this 3 year, prospective randomized multicenter efficacy trial is that a~     structured life-style intervention program with exercise training and mediterranean diet is~     effective regarding increased adherence to a mediterranean diet, reduction of body mass~     index, and increase of physical fitness.~   "
80249|NCT02516527|"~     The purpose of this study is to determine whether ipilimumab is effective in the treatment of~     select advanced (unresectable, metastatic, or recurrent) solid tumors in Chinese subjects.~   "
80291|NCT02515968|"~     The purpose of this study is to investigate whether propofol can improve quality of recovery~     compared to desflurane in patients undergoing robotic or laparoscopic gastrectomy.~   "
80292|NCT02515955|"~     The purpose of this study is to investigate the safety, tolerability and pharmacodynamics of~     JNJ-54175446 after multiple consecutive dose administrations~   "
80250|NCT02516514|"~     Current recommendations for the diagnosis of bacteremia based on the embodiment~     February-March blood cultures separated by a minimum interval of 30 minutes. Each blood~     culture comprises seeding a pair of aerobic and anaerobic vials inoculated each with 5 to 10~     ml of blood. The sensitivity and specificity of this technique depends essentially on the~     amount of blood removed since there is a direct relationship between the volume of blood~     inoculated into each flask and the efficiency of the technique. A preliminary study conducted~     at the University Hospital of Caen found that 14-30% of patients depending on the services~     had received only one blood culture. In addition, at least four blood cultures in 24 hours~     were taken for 10 to 20% of patients. The practice of a single blood culture reduces the~     sensitivity of the analysis due to insufficient total amount of blood collected. The practice~     of too many blood cultures increases the risk of false positive (presence of contaminating~     bacteria), generates extra work for healthcare personnel (and laboratory) and represents a~     significant cost for an unproven benefit.~      The investigators propose to evaluate a single blood culture sampling technique with seeding~     4 vials (2 aerobic and anaerobic 2).~   "
80251|NCT02516501|"~     Type of study: Pilot / phase I trial~      Study purpose To assess the impact of a dietary intervention during radio(chemo)therapy (RCT)~     on body composition changes~      Trial Treatment Patients will be split into a control group and intervention group 1. If~     willing to undertake a ketogenic diet for the duration of radiotherapy, patients are entered~     into intervention group 2.~        -  Group 1: On irradiation days irradiation after overnight fast + ketogenic breakfast~          consisting of 50-250 ml betaquick® (vitaflo, Bad Homburg, Germany) and 5-15 g Master~          Amino Acid Pattern (dr. reinwald healthcare gmbh+co kg, Schwarzenbruck, Germany).~        -  Group 2: Complete ketogenic diet plus 5-15g Master Amino Acid Pattern/day~        -  Control: No dietary intervention.~        -  All groups: Weight measurements and bioimpedance analysis (BIA) once per week, routine~          blood parameters and quality of life (QoL) questionnaire before, during and after RCT~      Endpoints~      Primary:~        -  Feasibility of the dietary intervention during RCT, measured by dropout rates~        -  Changes in body weight~        -  BIA phase angle and quantities derived from BIA variables~      Secondary:~        -  QoL~        -  Toxicities~        -  Blood parameters~        -  Grade of regression at time of surgery in case of rectum carcinomas~      Inclusion criteria~        -  One of the following tumor entities:~             -  Breast carcinoma~             -  Rectum carcinoma~             -  Head & Neck Cancer~        -  Histological confirmation of malignancy~        -  Signed written informed consent~        -  Karnofsky index ≥ 70~        -  Age between 18 and 75 years~        -  BMI between 18 and 34 kg/m^2~      Exclusion criteria~        -  Palliative patients, in particular with metastasis~        -  Type I diabetes~        -  Pregnancy~        -  Pacemaker and other metallic parts within the body~        -  Known defects in enzymes necessary for ketogenesis, ketolysis, fatty acid oxidation or~          gluconeogenesis~        -  Unable to speak or understand German~        -  Cognitive impairments or psychological disorders~        -  Renal insufficiency~      Planned accrual~        -  15 patients with colorectal and mammary tumor plus 5 patients with H&N cancer in~          intervention group 1~        -  15 patients with colorectal and mammary tumor plus 5 patients with H&N cancer in control~          group~        -  Minimum 5 patients of each tumor entity in intervantion group 2 Total: n ≥ 85 patients~      Study procedure~        1. Inclusion and full written informed consent.~        2. Baseline BIA measurement and blood work~        3. RCT with weekly BIA assessments; at least one blood withdrawal ± concurrent dietary~          intervention~        4. Final BIA measurement and blood work after radiotherapy~      Follow up For rectal carcinoma: Regression at time of surgery (c and p)~   "
80252|NCT02516488|"~     Comparison of confocal laser endomicroscopic in vivo diagnosis and ex vivo examination~     against surgical histopathology of cystic pancreatic lesions.~   "
80253|NCT02516475|"~     To study the effects of zinc supplement on anthropometric factors, Apelin and inflammatory~     markers in obese individuals, 50 obes person who referred to Diet and Nutrition clinic of~     Shahid Beheshti University of Medical Sciences will be randomly allocated to receive 50 mg~     zinc capsules or placebos for 15 weeks; both groups will be advised to adherence the~     investigators' diet . At the first and the end of the intervention,weight, body mass index~     (BMI), waist circumference, fat mass and lean body mass, concentration of zinc, albumin,~     hs-CRP, TNF-α and plasma apelin will be assessed and compared between groups.~   "
80254|NCT02516462|"~     Because a large proportion of the embryo's quality is dependent upon the egg, this~     investigation focuses on treatment of the oocyte during in vitro maturation (IVM). In typical~     IVF cycles, the egg is recovered when it is mature and ready to be fertilized. However, at~     this point the oocyte's quality has been set, and cannot be altered. Therefore, to have an~     impact on oocyte quality the use of in IVM is critical. Development of a successful IVM~     protocol for clinical use would not only provide an option for women of advanced maternal~     age, it would also reduce the cost of IVF due to fewer exogenous gonadotropins used for~     stimulation, and significantly lessen the risk of ovarian hyper-stimulation.~      The objective of this research study is to evaluate a newly developed oocyte maturation media~     system for human clinical use in assisted reproductive technology (ART).~   "
80255|NCT02516449|"~     The purpose of this study is to determine whether the use of shared decision making aids is~     more effective than usual care in improving asthma knowledge, lessening decisional conflict,~     and enhancing adherence to treatments and asthma control in adult patients with mild to~     severe asthma.~   "
80256|NCT02516436|"~     A randomized, double blind, active controlled study in approximately 40 opioid dependent~     subjects. Study duration is up to five days and includes a maximum of 3 days confinement in~     the clinic. Opioid dependent subjects who provide informed consent meet all entry criteria~     are eligible for enrollment into the study.~   "
80257|NCT02516423|"~     This randomized phase III trial compares ixazomib citrate, lenalidomide, dexamethasone and~     zoledronic acid with zoledronic acid alone to see how well they work when given after~     radiation therapy in treating patients with solitary plasmacytoma of bone. Ixazomib citrate~     may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~     Lenalidomide may help the immune system kill abnormal blood cells or cancer cells.~     Dexamethasone is a drug used in chemotherapy that may cause tumor cells to die. Zoledronic~     acid may prevent bone fractures and reduce bone pain, and may also improve survival. Standard~     treatment for this cancer is radiation therapy alone. It is not yet known whether ixazomib~     citrate, lenalidomide, dexamethasone and zoledronic acid or zoledronic acid alone is more~     effective, and whether adding these treatments after radiation therapy is more effective than~     radiation therapy alone in treating patients with solitary plasmacytoma of bone.~   "
80258|NCT02516410|"~     Study to evaluate the efficacy of VX-661 in combination with ivacaftor through Week 12 in~     subjects with cystic fibrosis (CF) who are heterozygous for the F508del mutation on the CF~     transmembrane conductance regulator (CFTR) gene and with a second CFTR mutation that is not~     likely to respond to VX-661 and/or ivacaftor therapy (F508del/not responsive [NR]).~   "
80259|NCT02516397|"~     The purpose of this clinical trial is to evaluate the safety and efficacy of a food~     supplement OMNIA compared to a placebo in reducing the body fat mass in 70 overweight~     subjects during 12 weeks treatment.~   "
80293|NCT02515942|"~     The purpose of this study is to evaluate the safety and efficacy of 12 (every 28 days)~     intravitreal (IVT) injections of CLG561 as a monotherapy and in combination with LFG316 as~     compared to sham in subjects with geographic atrophy.~   "
80260|NCT02516384|"~     Inflammatory bowel disease is a condition caused by gastrointestinal immune system~     dysregulation and affected by both genetic and environmental factors. Differences in~     intestinal bacteria exist between IBD patients and healthy controls, but the role of~     intestinal bacteria in the development and treatment of IBD remains largely unknown. Fecal~     microbiota transplantation (FMT) is the transfer of gastrointestinal bacteria from a healthy~     donor to a patient with altered microbial diversity with the intent of restoring a normal~     bacterial balance. Most studies focus on its use in treating Clostridium difficile (CDI), an~     infection characterized by dysbiosis. Given the role of dysbiosis in IBD, the investigators~     hypothesize that FMT may be beneficial in IBD. The purpose of this study is to prospectively~     examine the safety of FMT in the management of ulcerative colitis (UC).~   "
80261|NCT02516371|"~     This study aims to exam the subpopulation of lymphocytes and evaluate the clinico-pathologic~     correlations.~   "
80262|NCT02516358|"~     To quantify the local prevalence of diabetes mellitus in critically ill patients. To~     understand whether a correlation does exist between premorbid glycaemic control and glycaemic~     status in ICU. A subgroup analysis will be conducted to investigate whether a relationship~     does exist between Neuron Specific Enolase levels and glycaemic disorders.~   "
80263|NCT02516345|"~     This study aims to test whether incentives can motivate children to promote increased~     physical activity of a working parent while also increasing their own activity levels.~   "
80264|NCT02516332|"~     Coronary heart disease (CHD) is the leading cause of death in the United States; more than~     600,000 Americans suffer a fatal cardiac event each year. Traditional CHD risk factors such~     as high blood pressure, smoking, and elevated cholesterol do not fully account for the timing~     and occurrence of CHD events and individuals with elevated levels of anxiety appear to have a~     greater risk of cardiovascular events. The present study will examine the impact of aerobic~     exercise and Lexapro in the treatment of anxiety and cardiovascular biomarkers among~     individuals with CHD.~   "
80265|NCT02516319|"~     The purpose of this study is to 1) determine the feasibility of using Cardiox Liver Function~     Assessment System (LFA) to measure indocyanine green (ICG) clearance; 2) determine an~     adequate dose based on LFA technology and 3) determine an adequate time period for LFA~     determination.~   "
80266|NCT02516306|"~     The purpose of this study is to determine whether EV06 Ophthalmic Solution is safe and~     effective in improving distance corrected near vision in people who have presbyopia.~   "
80267|NCT02516293|"~     Due to the lack of information in the literature about the role of cardiac rehabilitation on~     Chagas heart failure, the aim of the present study was to evaluate the effects of a cardiac~     exercise program on functional capacity, cardiac function, respiratory muscle strength, body~     composition, biomarkers and quality of life among Chagas heart failure patients.~   "
80268|NCT02516280|"~     A pilot study was performed to investigate the feasibility of a large randomized controlled~     trial (RCT) to assess the effects of hyperbaric gaseous cryotherapy (HGC) on the change in~     knee flexion range of motion in the first two days after total knee arthroplasty.~   "
80269|NCT02516267|"~     The purpose of this study is to assess platelet aggregability by a point of care device~     (Multiplate®) to decrease the release time for coronary artery bypass graft (CABG ) in~     patients with acute coronary syndrome (ACS) in use of dual antiplatelet therapy.~   "
80270|NCT02516254|"~     The aim of this study is to evaluate the efficacy of daily intake of fortified bread with~     vitamin D on serum 25-hydroxyvitamin D level, glycemic and lipidemic status in healthy~     subjects compared to vitamin D supplement.~   "
80271|NCT02516241|"~     A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line~     MEDI4736 (Durvalumab) Monotherapy and MEDI4736 (Durvalumab) in Combination with Tremelimumab~     Versus Standard of Care Chemotherapy in Patients with Stage IV Urothelial Cancer~   "
80272|NCT02516228|"~     This study examines the safety and feasibility of suppressing epileptic discharges through~     inducing long term depression of the epileptic focus with transcranial electrical~     neuromodulation.~   "
80273|NCT02516215|"~     This is an observational clinical study, patients with systemic diseases will be enrolled~     according to the inclusion and exclusion criteria. 360 patients will received the examination~     of sublingual microcirculation by using sidestream dark filed video microscope. The~     microcirculation data includes total small vessel density, perfused small vessel density,~     microvascular flow index, and heterogeneity index. The patients will be divided into right~     groups according to their systemic diseases as follows: group 1 hypertension (60 patients),~     group 2 diabetes mellitus (60), group 3 hypertension and diabetes mellitus (60), group 4 end~     stage renal disease with hemodialysis (60), group 5 peripheral arterial occlusive disease~     (30), group 6 coronary artery disease (30), group 7 liver cirrhosis (30), and group 8 anemia~     (30).~   "
80274|NCT02516202|"~     This is a new application from the Menopause Strategies: Finding Lasting Answers for Symptoms~     and Health (MsFLASH) Clinical Trials network. Here we propose to conduct a large multicenter~     trial comparing two common treatments, a vaginal hormone tablet and an over-the-counter gel,~     with placebo to evaluate their effects on bothersome vaginal symptoms and sexual function,~     and to create a biorepository of specimens for future translational, mechanistic research on~     the etiology of vaginal symptoms.~   "
80275|NCT02516189|"~     The purpose of this study is to verify the effects of a strength training program on~     functional capacity, muscle performance and microcirculation in the elderly.~   "
80276|NCT02516176|"~     People who are living in the community following a stroke fall frequently. The ability to~     take a step in response to a balance disturbance helps to prevent falls but stroke survivors~     tend not to step with their paretic leg in these circumstances. This leaves them vulnerable~     to falls towards their paretic side. The purpose of this study is to train paretic limb~     stepping by having individuals stand sideways on a treadmill and respond to sudden~     accelerations of the treadmill.~   "
80277|NCT02516163|"~     This is a prospective, non-randomized, study of the clinical outcomes of participants that~     receive the Stryker Triathlon® Total Knee System for Total Knee Arthroplasty implanted using~     ShapeMatch® Cutting Guides.~   "
80278|NCT02516150|"~     This study will test the hypothesis that a BAC (blood alcohol content) of 0.1% will not~     significantly alter the anti-hypoglycemic effect of mico-dose glucagon in individuals with~     type 1 diabetes.~   "
80279|NCT02516137|"~     The purpose of this study is to find out if individuals with tight hamstring muscles who~     receive dry needling in addition to a standard stretching exercise program, show an~     improvement in hamstring tightness and function compared to individuals with tight hamstrings~     who receive either sham dry needling or no needling (blunt needle) in addition to a standard~     stretching program.~   "
80280|NCT02516124|"~     The purpose of this study is to assess the effectiveness of Autologous Hematopoietic Stem~     Cell transplantation (AHSCT) for early severe or rapidly progressive Systemic Sclerosis (SSc)~     as currently performed by different study protocols used across Europe in various EBMT~     centres through the careful recording and analysis of routinely collected clinical and~     biological data.~   "
80281|NCT02516111|"~     The present study is designed as a single-centre, randomized, controlled clinical trial to~     evaluate and compare the clinical efficacy of autologous PRF, 1% alendronate (ALN) and 1.2%~     atorvastatin (ATV) gel placement with open flap debriedement in treatment of intrabony~     defects in patients with chronic periodontitis.~   "
80282|NCT02516098|"~     Determine bioequivalence of two forumulations with hyoscine butylbromide 10mg sugar coated~     tablets.~   "
80283|NCT02516085|"~     The purpose of the study is to show that the intake of L-arginine and metformin improves~     muscle function and delays disease progression in patients with Duchenne's muscular~     dystrophy.~   "
80284|NCT02516072|"~     With an increasingly ageing population the incidence of peripheral arterial disease (PAD) is~     rising. With approximately one quarter of all PAD patients ultimately progressing to Critical~     Limb Ischaemia (CLI), increased demands are being placed on vascular imaging to accurately~     assess stenotic lesions. Early infrainguinal lesions (i.e. TASC A & B) can be treated with~     angioplasty+/- stenting and accurate assessment relies on the imaging gold standard of~     angiography.~      Patients with PAD often have concomitant co morbidities such as diabetes and chronic renal~     impairment placing them at increased risk of developing contrast induced nephropathy (CIN)~     when exposed to iodinated contrast media. High risk individuals with decreased eGFR <60ml/min~     have a risk of between 20-30% of developing CIN. They have increased morbidity and mortality~     risks with a greater need for dialysis and prolonged in patient hospital stays. Ideally, the~     investigators should be searching for ways to decrease the incidence of CIN. Animal studies~     and more recently pilot human trials have shown that subjecting a remote vascular bed to a~     brief ischaemic stress, followed by a period of reperfusion; in what has been termed remote~     ischemic preconditioning (RIPC), may confer a protective benefit against the development of~     CIN. This study aims to determine if RIPC can protect against CIN in patients undergoing~     elective peripheral angiography for infrainguinal disease.~   "
80285|NCT02516059|"~     Cystectomy with urinary diversion (ileal conduit, ileal orthotopic neobladder, catheterizable~     ileal pouch) is major abdominal surgery, which is associated with a high incidence of~     gastrointestinal complications.Perioperative techniques aiming at an early return of bowel~     function are to be pursued.~      Optimal postoperative pain management is one of the key factors leading to enhanced recovery~     after surgery. The perioperative use of an epidural analgesia for major abdominal surgery is~     established, not only because of its excellent analgesic properties, but also because it can~     accelerate the return of bowel function. However, epidural analgesia is associated with~     additional costs, need for close monitoring and nursing. In addition each supplemental day~     with an indwelling epidural catheter increases the risk of infection. So it is recommended to~     re-assess the risk/benefit ratio of an epidural analgesia after 4 days, if not sooner.~     Therefore, it is important to develop strategies that reduce its duration without impairing~     the benefits. Systemic analgesics with prolonged-release oral formulation like oral oxycodone~     (Oxycontin®) or combined drug mixture (oral oxycodone/naloxone (Targin®)) could be a valuable~     alternative pain treatment as a second analgesic step, starting on postoperative day (POD) 3,~     so that the epidural catheter could be removed earlier without impairing postoperative~     enhanced recovery including return of the bowel function. Both oxycodone and naloxone orally~     administered are a recognized and accepted treatment option.~      The objective of this study is to evaluate the implementation of an oral opioid with or~     without naloxone in the early postoperative period in patients undergoing open radical~     cystectomy with urinary diversion and intraoperative and early postoperative use of epidural~     analgesia. The investigators expect an unchanged early return of the bowel function and equal~     analgesia with a reduced length of stay of the epidural catheter (primary endpoint), thus~     potentially reducing epidural catheter associated complications and lowering costs (nursing~     and pain service).~   "
80286|NCT02516046|"~     This study is designed to test the relationship between ante-mortem 18F-AV-1451 Positron~     Emission Tomography (PET) imaging and tau neurofibrillary pathology associated with~     Alzheimer's disease (AD), as measured at autopsy.~   "
80287|NCT02516033|"~     Recently a combined approach of surgeon ablation in combination with endocardial ablation~     (hybrid ablation) has been introduced. This therapy has shown excellent results in patients~     with previous failed endocardial ablation for paroxysmal atrial fibrillation as well in~     patients with persistent atrial fibrillation. The investigators hypothesize that the severity~     of atrial remodeling in patients with atrial fibrillation can be measured by clinical~     factors, echocardiographic parameters, circulating biomarkers and genetic background, and~     that these factors can be used to identify a risk profile to predict failure of the hybrid~     ablation therapy in patients with atrial fibrillation. Aim of this study is to determine a~     risk profile based on clinical correlates, circulating biomarkers, and genetic background~     associated with failure of the hybrid ablation procedure, in a prospective single center~     registry setting. The investigators evaluate all consecutive patients who have agreed to~     undergo the hybrid ablation procedure because of atrial fibrillation. The investigators aim~     for a total of 250 participants. Extra study related procedures include blood sampling for~     biomarkers and genetic analysis, prolonged Holter monitoring for documentation of recurrences~     of atrial fibrillation/atrial flutter/atrial tachycardias, and a quality of life~     questionnaire. Total follow-up will be five years.~      Main study endpoint is failure of the hybrid ablation procedure in patients with atrial~     fibrillation, i.e. any (a)symptomatic atrial fibrillation/atrial flutter/atrial tachycardia~     >30sec without anti-arrhythmic drugs at one year of follow-up by ECG recording and 3-day~     Holter monitoring.~   "
80288|NCT02516020|"~     To compare the effectiveness of single step culture media and continuous uninterrupted~     culture media on blastulation rate~   "
80289|NCT02515994|"~     Randomized, double-masked, controlled, 2-arm parallel group, multi-site, 3-month dispensing~     study of Johnson & Johnson Vision Care, Inc. (JJVCI) Investigational contact lens, compared~     with a marketed, monthly replacement contact lens. Subjects will wear the JJVCI~     investigational contact lenses on a daily wear basis.~   "
80290|NCT02515981|"~     The New Hampshire Medicaid Wellness Incentive Program (WIP) will address both the health~     disparity and increased costs by providing incentivized health promotion programs to~     overweight or obese and/or tobacco-smoking Medicaid beneficiaries receiving services at New~     Hampshire's 10 regional Community Mental Health Centers (CMHCs).~   "
80294|NCT02515929|"~     Aim: To evaluate the effectiveness on tissue response of the new nutritional supplement made~     of Oligomeric Proanthocyanidins (OPCs) in induced gingivitis after 21 days of use.~      Material and Methods: A double-blind randomized controlled prospective clinical trial was~     carried out on 20 patients divided into an experimental group treated with the OPCs pill and~     a control group treated with placebo, after fulfilling the selection criteria. Patients had~     to come 4 times during the study to register the Silness and Loe and Gingival Bleeding index,~     plaque index, inflammatory crevicular fluid study (IL6) and changes in brightness of the~     gingiva. No complementary hygiene methods were allowed during the 21 days.~   "
80295|NCT02515916|"~     The purpose of this study is assess the effects of oncology treatment on ovarian reserve and~     also to better understand the experiences, thoughts and feelings of women scheduled to~     undergo chemotherapy/radiotherapy and seeking fertility preservation at Weill Cornell Medical~     College (WCMC).~   "
80296|NCT02515903|"~     Views for surgery method selection of intracerebral hemorrhage are still controversial. Since~     the application of neuroendoscopic technique in intraventricular hemorrhage was confirmed~     effective and safe, some investigators have attempted to use endoscopic strategies to~     evacuate intracerebral hematomas. Some significant advances have also been reported in~     endoscopic hematoma evacuation when compared to conventional craniotomy. However, it is still~     crucial to implement a prospective and controlled study to evaluate the efficiency and safety~     of endoscopic technique in the treatment of intracerebral hemorrhage. In this study, the~     investigators will exclusively select some patients with intracerebral hemorrhage in the~     basal ganglia region. This study will compare the efficacy and safety of endoscopic surgery~     versus stereotactic aspiration on neurologic outcomes for patients with intracerebral~     hemorrhage.~   "
80297|NCT02515890|"~     The purpose of this study is to determine the effects of pain on facilitating long-term~     auditory memory in the presence and absence of distinct intravenous anesthetics. The ability~     to identify previously presented words from a list will asses the degree of memory formation.~     In a subset of subjects, functional magnetic resonance imaging will be used to identify the~     neural correlates of memory inhibition or facilitation by the combination of pain and~     anesthetic used. The primary hypothesis is that pain will enhance memory formation, and that~     this will be mediated by additional neural pathways compared to those used to encode words~     not paired with pain. The study will occur over 4-5 visits and involves no long-term follow~     up.~   "
80298|NCT02515877|"~     The treatment of cervical tumors depends on the stage of the disease. In advanced forms~     (nodal and / or local extension to the vagina and / or parameters) , radiotherapy associated~     with curietherapy , plays a major role. Until recently this association was the standard~     treatment for advanced stage uterine cancer. With this combination, rates of local failures~     (evolutionary prosecution and local recurrences) were 20 to 50% in stages IIb and 50-75 % for~     stage III. More than 50% for patients with a cervical cancer locally advanced (FIGO stages II~     / IV) . The standard treatment, external radiotherapy followed by curietherapy allows expect~     survival rates at 5 years for approximately 30-45 %. For ten years, numerous studies have~     evaluated the addition of concurrent chemotherapy to radiotherapy in cancer of the cervix.~     More than 19 randomized trials have been published. A meta-analysis of these trials was~     undertaken to assess the role of radiochemotherapy in cancers of the cervix. The first~     meta-analysis published by the Cochrane Collaborative Group, taking into account 4580~     patient, shows an improvement in survival, both in terms of progression free survival and~     overall survival for patients treated with radio chemotherapy respectively 16% and 12 % (p <~     0.0001). The rate of metastasis is also decreased (p < 0.0001). Survival rates were~     significantly better when platinum salt was used ( p < 0.0001 ) . However, no clinical~     benefit of chemoradiotherapy has been demonstrated for tumors stages [1, 2] locally advanced,~     possibly due to small number of patients. The investigators have previously shown that~     antiviral agents used in preclinical models, Cidofovir® causes the selective~     radiosensitization of cells infected by the papillomavirus (HPV). This trial proposes to~     study a new concept to increase radiochemotherapy efficiency: the modulation of the~     expression of viral oncoproteins HPV virus by an antiviral agent.~   "
80299|NCT02515864|"~     A Placebo-controlled, Four Way Crossover Study to Investigate the Effect on QT/QTc Interval~     of a Single Dose of FYU-981, Compared with Placebo, Using Moxifloxacin as a Positive Control,~     in Healthy Male and Female Volunteers.~   "
80300|NCT02515851|"~     For patients undergoing open-reduction internal-fixaton (ORIF) of isolated distal radius~     fractures, administration of 66.5 mg of liposomal bupivacaine to operative field may decrease~     the need for post-operative narcotic pain medication.~   "
80301|NCT02515838|"~     A Multi-Centre, Phase II, Randomized, Double-Blind, Placebo-Controlled Study to investigate~     Efficacy and Safety of Sevuparin Infusion for the Management of Acute Vaso-Occlusive Crisis~     (VOC) in Subjects with Sickle-Cell Disease (SCD).~   "
80302|NCT02515825|"~     The purpose of this non-significant risk study is to collect performance information~     regarding the use of the CADence system under normal conditions of use. This is a~     prospective, multi-center study to capture information on CADence agreement with coronary~     angiograms, on subjects who are already scheduled for coronary angiography.~   "
80303|NCT02515812|"~     Cardiological examination constitute one of the major directions in nuclear medicine for~     detection of myocardial ischemia in patients suspected of coronary disease. In Caen, they~     constitute 20% of the activity of nuclear medicine. Systolic heart failure (HF) ischemic or~     nonischemic origin represents a new area of activity of the nuclear cardiology. This is HF~     stratification study based on cardiac adrenergic function after injection of a tracer:~     I-123-MIBG. The team Caen nuclear cardiology is one of two teams recognized internationally~     in the field of evaluating the cardiac sympathetic innervation in cardiomyopathies. Numerous~     publications from 1992 to the present day have reported encouraging results for the daily use~     of this tracer in the evaluation of patients with LV dysfunction IC. Recently, interest in~     using the MIBG has been shown as a prognostic marker of HF in a prospective study of 961~     patients. Typically, the camera used was an Anger camera with collimating Nai standard called~     parallel holes.~      The main objective is to validate the measurements of cardiac adrenergic function evaluated~     by cardiopulmonary mediastinal reports and sympathetic innervation scores VG after injection~     of I-123-MIBG in 80 patients with heart failure.~   "
80304|NCT02515799|"~     The purpose of this study is to evaluate the mucolytic activity of Tacholiquine® compared to~     saline (0.9%) in chronic bronchitis patients. Lung function parameters, biomarker profiles in~     sputum and serum, and clinical symptoms by standardized questionnaires [COPD activity index~     (CAT), Baseline Dyspnea Index (BDI) & Transition Dyspnea Index (TDI)and the St. George's~     Respiratory Questionnaire (SGRQ)] will be evaluated in response to Tacholiquine® vs. saline~     in chronic bronchitis patients.~   "
83540|NCT02473484|"~     The aim is to classify high grade glioma by matrix-assisted laser desorption/ionization mass~     spectrometry imaging (MALDI MSI). In order to provide more specific informations for the~     diagnosis and the prognosis of high grade glioma.~   "
80305|NCT02515786|"~     During normal breathing, the upper and lower airways performs the priming of inspired gas:~     humidification, heating and filtering from nose to the bronchios for adequate gas exchange~     occurs in the lungs. Many patients with severe or advanced cardiopulmonary conditions (cystic~     fibrosis, chronic obstructive pulmonary disease, pulmonary hypertension, advanced heart~     failure among others) may develop chronic respiratory failure and require treatment with~     oxygen therapy. High fractions of inspired oxygen have been associated with deleterious~     effects on the nasal ciliary beating and nose mucociliary transport. At home assistance, the~     patient with chronic respiratory receives oxygen via nasal cannula to the patient has been~     applied with and without humidification, however, does not know the effects of these two~     types of dry and humidified administration on the mucosa of the nose, airways and lungs. The~     investigators will assess the subject in use of home oxygen therapy at baseline, 12 hours, 7~     days 30 days, 12 months and 24 months.~   "
80306|NCT02515773|"~     A prospective, large, pragmatic, randomized trial to study the impact of METFORMIN and~     healthy lifestyle intervention (LIFE) vs. LIFE alone on patient-centered outcomes of body~     weight, SGA-adherence and satisfaction, psychiatric symptom burden (e.g. mood/anxiety), and~     Quality of Life.~   "
80307|NCT02515760|"~     Non-small cell lung cancer is characterized by aggressive growth and treatment resistance.~     New approaches include immunotherapeutic strategies but spontaneous immune responses against~     tumor antigens remain unclear. The aim of this study is to characterize localization and~     frequencies of spontaneously induced memory T cells specific for a panel of tumor-associated~     antigens in peripheral blood and bone marrow of non-small cell lung cancer patients.~   "
80308|NCT02515747|"~     The purpose of this study is to explore the role of lipoprotein(a) and apolipoprotein(a)~     phenotype in fatal and non-fatal cardiovascular disease (CVD) events risk in coronary disease~     patients divided on the basis of management strategy - medical, endovascular or open cardiac~     surgery.~   "
80309|NCT02515734|"~     This study is to verify the advantage of FOLFOXIRI plus cetuximab over FOLFOXIRI plus~     bevacizumab as the first-line therapy in metastatic colorectal cancer patients with RAS~     wild-type tumors.~   "
80310|NCT02515721|"~     Early detection of gastric intestinal metaplasia (GIM) intraepithelial neoplasia (IN), and~     gastric cancer are essential to improve patients' outcomes. This study aims to compare the~     diagnostic yield of GIM, IN and early gastric cancer (EGC) by iScan combined probe-based~     confocal laser endomicroscopy (pCLE) and iScan alone.~   "
80311|NCT02515708|"~     Normothermic machine perfusion (NMP) preservation is a promising method to decrease the~     complication of marginal donor livers compared to cold storage (CS). The aim of this project~     is to assess safety and feasibility of NMP in human liver transplantation. This will be a~     single center prospective cohort pilot study. Thirty-two livers with acceptable quality for~     transplantation will be preserved with NMP in 2-18 hours and transplanted. The follow-up~     period will be 6 months post-transplantation. The outcome will be compared to 100 historical~     patients transplanted in our program in the past 5 years (liver preserved using CS) with~     matched characteristics on age, Model for End-Stage Liver Disease (MELD) score, preservation~     time, etc.~   "
80312|NCT02515695|"~     Phase I study aiming at:~        -  assessing the absolute bioavailability, pharmacokinetic profile, and dose~          proportionality of interferon beta-1a (HSA-free solution in pre-filled syringes) after~          i.v. and s.c. administration as well as the pharmacodynamic profile to create the link~          with available surrogate markers investigated with both formulations used clinically,~          lyophilisate with HSA (HSA+) and solution without HSA (HSA-);~        -  gathering further information on safety and tolerability of interferon beta-1a over dose~          range,including local and systemic tolerance, body temperature, vital signs, and a~          battery of exploratory sickness behavior tests.~   "
80313|NCT02515682|"~     We propose to perform a 24-week randomized, double-blind a placebo-controlled trial among 207~     non-equol producing postmenopausal women with prehypertension to examine the effectiveness of~     equol (10mg and 20mg/d) on 24h ambulatory blood pressure, vascular function and other~     cardiovascular risks (lipid profile, glycemic control and inflammatory biomarkers) and~     explore the optimal dosage of equol.~   "
80314|NCT02515669|"~     The purpose of this study is to determine the safety and tolerability of BMS-986089 in boys~     with Duchenne Muscular Dystrophy with any genetic mutation.~   "
80315|NCT02515656|"~     POLYGYNAX® is a broad spectrum combination of nystatin, neomycin and polymixin B indicated~     for the local treatment of vaginitis due to sensitive germs and treatment of non specific~     vaginitis of adults. POLYGYNAX® has been marketed in France since 1969.~      Nevertheless, despite the well established use of POLYGYNAX®, there is no clinical study~     supporting the interest of the combinaison of antifungal and antibiotics agents versus~     antifungal agent alone.~      The aim of this project is to demonstrate that POLYGYNAX® is more effective than miconazole~     in the treatment of women experiencing symptoms of infectious vaginitis.~   "
80316|NCT02515643|"~     Endothelial dysfunction one-year after transplantation mainly depends on~     transplant-associated factors and only marginally on reduced renal function.~      OBJETIVES Primary objective Estimate the contribution of renal dysfunction to endothelial~     dysfunction in two cohorts of patients, living kidney donors and their transplant recipients.~      Secondary objectives~      To evaluate in both cohorts of patients before and after nephrectomy/transplantation the~     evolution of the following parameters:~        1. Renal function (iohexolGFR, proteinuria/microalbuminuria).~        2. Blood pressure (24 h ambulatory blood pressure measurement)~        3. Surrogate variables of subclinical atherosclerosis (carotid ultrasound, ankle-brachial~          index, pulse wave velocity).~      DESIGN Non-interventional, prospective, multicenter, longitudinal study of two cohorts:~     living kidney donors and their transplant recipients.~   "
80317|NCT02515630|"~     This study will evaluate the transfusion independence response rate in transfusion-dependent~     adults with myelofibrosis after treatment with momelotinib (MMB).~   "
80362|NCT02515045|"~     To compare the use of an injectable compound containing an antibiotic and an~     anti-inflammatory at time of cataract surgery to standard of care that is the use 3 different~     topical medications to prevent inflammation and infection after routine cataract surgery.~   "
80363|NCT02515032|"~     SF-C002 is a pilot study in patients with newly diagnosed NSCLC suffering from involuntary~     weight loss. The study is 12 weeks, double-blinded, placebo controlled and the main objective~     is to study the safety and tolerability of Nutrifriend Cachexia.~   "
80318|NCT02515617|"~     In France, despite the implementation of bundles to prevent Ventilator-Associated Pneumonia~     (VAP) in the last decades, the VAP incidence remains high above 10 per cent. In the last~     american recommendations of VAP prevention, the drainage of subglottic secretions (SSD) has~     been notified among the basic practices to prevent VAP. Nevertheless, the diffusion of SSD~     in ICUs remains limited. This situation is largely due to the initial overcost of the~     specific endotracheal tubes allowing SSD and to the unavailability of these devices in~     medical units in which patients are intubated before the ICU admission. So, this pragmatical~     cluster randomized and cross-over study evaluates the medico-economic impact of the~     subglottic secretions drainage in addition to VAP prevention bundles in ICU.~   "
80319|NCT02515604|"~     A randomised controlled trial assessing the efficacy of single versus repeated dose of~     vaginal misoprostol for the treatment of early pregnancy failure.~   "
80320|NCT02515591|"~     Validation study to use the disposable bronchoscopes in healthy volunteer research~     bronchoscopies to ensure adequate sample and cell yield.~   "
80321|NCT02515578|"~     Heart disease and strokes cause one in three deaths reported each year in the United States.~     Primary care practices need to implement new research findings that help decrease patients'~     risk for heart disease and stroke. This project will help to build primary care practice~     capacity for quality improvement and change management in small and medium size primary care~     practices in Colorado and New Mexico. This project will also help practices implement~     patient-centered outcomes research findings.~   "
80322|NCT02515565|"~     Acute respiratory infections are the fourth cause of hospitalization in elderly. Various~     studies have examined the impact of hospitalization in patients with respiratory pathology,~     showing the need of interventions in order to reduce the impact of hospitalization. The~     objective of this study is to examine whether a physical therapy intervention can reduce~     impairment in patients hospitalized due to pneumonia.~   "
80323|NCT02515552|"~     Fibromyalgia is a complex chronic illness affecting 6-12 million Americans. Self-management~     strategies play a key role in reducing symptoms and maintaining functioning. The proposed~     project offers a web-based self management tool that enables FM sufferers to identify~     significant linkages between their personal symptom levels and their personal self-management~     efforts over time in order to plan their own optimal approach to disease management.~   "
80324|NCT02515539|"~     The purpose of the study is to generate early US feasibility data of the CardiAQ™~     Transcatheter Mitral Valve Implant System.~      The study will enroll patients with moderate to severe mitral valve regurgitation who are~     considered high risk for mortality and morbidity from conventional open-heart surgery.~   "
80325|NCT02515526|"~     Protocol title: Effect of acute alcohol consumption on the activity of major cytochrome P450~     enzymes, NAT2 and P-glycoprotein.~      Objectives: The study is mainly conducted to evaluate the effect of acute alcohol consumption~     on the activity of the most important drug metabolising cytochrome P450 enzymes CYP1A2,~     CYP2C9, CYP2C19, CYP2D6, intestinal CYP3A4, hepatic CYP3A4, NAT2 and on the activity of the~     drug transporter p-glycoprotein (intestinal and renal).~      The study should also provide basis for a planned clinical study on interactions caused by~     chronic alcohol intake.~      Design: Single center, open-label, two-way, cross-over study with randomly allocated~     sequences Test-Reference or Reference-Test.~      The study is not a clinical drug study according to the German Drug Act.~      Clinical phase: Not applicable~      Volunteers: 16 healthy male and female subjects are planned for completion in accordance with~     the protocol, i.e. with evaluable/analysable data for all periods and treatments.~      Clinical centre: Department of Pharmacology, Clinical Pharmacology Unit (KPH), University of~     Cologne, Gleueler Str. 24, 50931Köln, Germany~   "
80326|NCT02515513|"~     The relationship between myopenia, nutritional status, and long-term oncologic outcomes~     remains poorly characterized in patients with anatomically resectable pancreatic cancer (PC).~     The investigators want to look at muscle properties in pancreatic cancer patients to~     determine possible therapeutic options toward better nutritional status. Patients with benign~     right upper quadrant pathology will be utilized as controls for the study.~      The researchers hypothesize that improving cancer cachexia in PC will improve the quality of~     life and ultimately increase overall survival. The long term goal of is to identify areas of~     intervention to prevent and/or improve cachectic events in PC in order to significantly~     improve clinical outcomes. The first step in this long term goal is to fully characterize~     cachexia in the condition of PC. This research is to understand and modify the local response~     within skeletal muscle leading to a clinically relevant persistent wasting and to understand~     and interrupt the systemic stimulus produced by the tumor local environment resulting in~     these muscle specific mechanisms.~   "
80327|NCT02515500|"~     The study is designed to evaluate the efficacy of a cigarette reduction intervention using a~     novel device called the Quitbit, a digital lighter paired with a smartphone mobile~     application, to enhance self-regulatory techniques for reducing cigarettes smoked per day~     toward cessation.~   "
80328|NCT02515487|"~     The main goal of this project is to identify and remediate the cognitive difficulties,~     including processing speed and attention deficits in individuals who have undergone~     chemotherapy treatment. Recent research has demonstrated objective cognitive deficits~     following chemotherapy and that it is not an emotional reaction to the cancer diagnosis as it~     was once considered. There are a large number of woman diagnosed and treated for breast~     cancer that experience chemotherapy induced cognitive deficits.~      Subjects who participate in the study will be evaluated for cognitive abilities prior to~     chemotherapy treatment and after completion of chemotherapy. Participants will then have the~     option to participate in the second phase of the study, which involves the use of a~     computer-based Brain Fitness Program for 12 weeks. This is followed by another cognitive~     evaluation.~   "
80329|NCT02515474|"~     Protection of Oddi's sphincter remains a huge argument especially in the long term~     complications like common bile duct stone recurrence or cholangitis after ERCP, which~     determined to destroy the sphincter of Oddi. The purpose of this study is to compare the~     long-term outcomes of ERCP sequential LC versus LCBDE for choledocholithiasis.~   "
80364|NCT02515019|"~     Electroencephalographic-based monitoring systems such as the bispectral index (BIS) may~     reduce anaesthetic overdose rates. The investigators hypothesised that goal-directed~     sevoflurane administration (guided by BIS monitoring) could reduce the sevoflurane plasma~     concentration (SPC) and intraoperative vasopressor doses during on-pump cardiac surgery in a~     prospective, controlled, sequential two-arm clinical study.~   "
80330|NCT02515461|"~     The investigators aim to investigate whether low energy shockwave therapy (LE-SWT) can~     preserve kidney function in diabetic patients. Participants in this study will receive LE-SWT~     treatment 6 times over 3 weeks. The treatment is non-invasive and has no known side effects.~     Previous studies have shown that LE-SWT induces angiogenesis. The investigators hypothesize~     that chromium-ethylenediaminetetraacetic acid (EDTA) renal clearance remains stable or~     increases in treated patients. Furthermore, kidney biopsy should show no signs of damage to~     the tissue and possibly neo-vascularization. In this project, the investigators shall also~     investigate LE-SWT effect on urinary markers of tubular damage and urinary nitric oxide~     indices. Patients' self-reported quality of life will be assessed using Short Form 36 version~     2 (SF-36v2) Health Survey.~      There is an 18-months follow-up on patients. Only patients between 18-65 years old with~     moderate chronic kidney failure from diabetes will be included.~      This project is an interventional prospective study. 30 patients with moderate kidney failure~     will be recruited from the Department of Endocrinology, Odense University Hospital, Denmark.~     LE-SWT treatment will be performed in the ambulatory of Department of Urology. Patients will~     be hospitalized for 1 day in the Department of Nephrology when kidney biopsy is taken (two~     times in study period).~   "
80331|NCT02515448|"~     Ventilator associated pneumonia (VAP) remains in the intensive care unit the infection~     associated with the highest morbidity and mortality.~      Respiratory infection with resistant organism are increasing in prevalence. Because of lack~     of alternatives, amino glycoside, old antibiotics family, can be used for several infection.~      Aerosolized Amikacin or Tobramycin are used in mechanically ventilated patients for~     respiratory infections. Gentamicin,which is effective against numerous multi drug resistant~     Gram-negative organism and Gram-positive like Staphylococcus aureus, could be a great option~     for nebulisation.~      The investigators assume that nebulisation of gentamicin allows to obtain a higher lung~     concentration while assuring a systematic toxicity much lesser than a parenteral~     administration.~   "
80332|NCT02515435|"~     The development of anti-angiogenesis drugs has led to renewed enthusiasm in lung cancer~     treatments. Apatinib, also known as YN968D1, is a tyrosine kinase inhibitor which selectively~     inhibits the vascular endothelial growth factor receptor-2 (VEGFR-2) and also represents mild~     inhibition to PDGFR, c-Kit and c-src tyrosine kinases. It is an orally bioavailable, small~     molecule agent which is thought to inhibit VEGF-mediated endothelial cell migration and~     proliferation thus blocking blood vessel formation in tumor tissues. Previous studies have~     identified that apatinib was well tolerated at doses below 750mg daily. In phase I/II study,~     investigators reported an objective response rate of 68%. In a phase III trial conducted in~     advanced pretreated gastric cancer, the median overall survival was significantly prolonged~     in the apatinib group compared with placebo group. Thus, in this trial, the investigators aim~     to investigate the efficacy and safety of apatinib in previously treated advanced~     non-squamous non-small cell lung cancer.~   "
80333|NCT02515422|"~     Aim: To assess the analgesic efficacy of subcutaneous infiltration of ketamine, either alone~     or as an adjuvant to bupivacaine, following CS and to compare their effects on postoperative~     pain scores and opioid consumption.~      Methods: Included patients were allocated to four treatment groups using computer-generated~     randomization number chart as follows; Group 1 (Ketamine, n=30) received subcutaneous~     infiltration of ketamine, Group 2 (Bupivacaine, n=30) received subcutaneous infiltration of~     bupivacaine 0.5%, Group 3 (Ketamine+Bupivacaine, n=30) received subcutaneous infiltration of~     ketamine+bupivacaine 0.5% and Group 4 (Placebo, n=30) received subcutaneous infiltration of~     placebo (0.9% saline solution). Patients, anesthetist, surgeon, and other medical and nursing~     staff were blinded to the contents of the medications. VAS scores at resting and on coughing~     and analgesic consumptions were compared.~   "
80334|NCT02515409|"~     The purpose of this study is to determine whether heated humidified high flow nasal cannula~     (HHHFNC) is effective as a treatment of obstructive sleep apnea syndrome (OSAS) compared to~     continues positive airway pressure (CPAP) treatments in children and to compare their~     adherence and compliance.~   "
80335|NCT02515396|"~     A Phase 1a, randomized, placebo controlled, two-way crossover study is to determine the~     effect of inhaled MMI-0100 compared to placebo following LPS challenge on inflammatory~     markers.~   "
80336|NCT02515383|"~     The goal of this research study is to learn if a symptom questionnaire used for adults at MD~     Anderson can be improved to better understand the symptoms experienced by 13-17 year old~     patients with cancer.~   "
80337|NCT02515370|"~     The main goal of the study is to support HIV-infected pregnant women initiated on PMTCT~     Option B+ during antenatal to adhere to lifelong ART and postpartum care visits through an~     enhanced group peer support intervention called friends for life circles.~   "
80338|NCT02515357|"~     Obstructive sleep apnea (OSA) is a sleep disorder characterized by recurrent episodes of~     partial or complete collapse of the upper airway during sleep, leading to pauses of breathing~     and arousals. Although previously considered as a local abnormality of the respiratory track,~     it is nowadays recognized as a systemic disease and an important cause of morbidity and~     mortality, since it is strongly associated with obesity (especially abdominal obesity) and~     cardiometabolic diseases, including cardiovascular diseases and diabetes mellitus.~     Interestingly, recent hypotheses support that the metabolic syndrome pathology, including~     insulin resistance, inflammation and oxidative stress may be involved in OSA pathogenesis.~     The modification of lifestyle habits, e.g. in terms of diet and physical activity, is~     currently explored as a mean of managing the disease in combination with the first line~     treatment, i.e., the application of continuous positive airway pressure (CPAP) during sleep.~     The available data support that weight loss, achieved through lifestyle modification,~     effectively reduces the severity of OSA and improves the associated cardiometabolic disorders~     in overweight or obese patients. However, studies exploring the potential effect of diet's~     quality or other lifestyle habits (such as physical activity) on OSA severity, besides weight~     loss, are currently lacking. Given that a Mediterranean dietary pattern, as well as other~     lifestyle habits adopted by the populations in the Mediterranean region, have been proven~     beneficial both for the prevention and the resolution of the metabolic syndrome and its~     associated cardiometabolic diseases, the aim of the present randomized, controlled,~     single-blind study is to implement an intensive intervention based on the Mediterranean~     lifestyle (hypocaloric diet and 7 group lifestyle counselling sessions) and to evaluate its~     potential benefits, compared with standard care (hypocaloric diet and written advice for~     healthy lifestyle), in a sample of patients with OSA.~   "
80365|NCT02515006|"~     Persistent insomnia is highly prevalent complaint in cancer survivors, but is seldom~     satisfactorily addressed. The adaptation to cancer care of a validated, cost-effective~     intervention may offer a practicable solution. The aim of this study was to investigate the~     clinical effectiveness of homeopathy for insomnia.~   "
80366|NCT02514993|"~     -  Analysis of patient data and computed tomography scan of polytraumatized patients~          thoracic spine fractures~        -  A concomitant sternal fracture was identified an indicator for an unstable thoracic~          spine fracture~   "
80339|NCT02515344|"~     Objective : to demonstrate that providing to GPs a list of their patients who are not~     compliant to colorectal cancer screening will 1) enhance patient participation to screening,~     and 2) decrease the proportion of cancer diagnosed outside the screening organisation. Design~     : Randomised controlled study, 3 parallel arms. Enrollment: GPs allocated in the 3 groups of~     the study will be all GPs 1) from the Loire-Atlantique and Vendée geographic area (1300 GPs~     on average) and 2) who have more than 100 patients in their patient list (based on data~     provided by the Healthcare Insurance System Services). Patients will be eligible to the study~     depending on their eligibility to the Faecal Occult Blood Test for colorectal cancer~     screening : 1) they should be older than 50 and younger than 74; 2) they should not have a~     personal history of colorectal cancer (or history of adenoma bigger than 1 cm) nor a family~     history of colorectal cancer. Main outcomes measures : Patient participation to colorectal~     cancer screening, and number of cancers screened in (versus diagnosed outside) the screening~     procedure.~   "
80340|NCT02515331|"~     The purpose of the present study was to determine whether LHW090 displays the clinical safety~     and efficacy profile to support further development in patients with resistant hypertension.~   "
80341|NCT02515318|"~     Chronic Obstructive Pulmonary Disease (COPD) is projected to be the fifth leading burden of~     disease worldwide by the year 2020. An acute exacerbation of COPD (AECOPD) is defined as an~     acute event characterized by a worsening of the patient's respiratory symptoms that requires~     a modification in the medication. AECOPD are frequent (mean of 1-4 exacerbations each year).~     It increases in frequency with the severity of the disease. The objective of this study is to~     examine whether a physical therapy intervention can reduce impairment in patients with COPD~     during hospitalization due to an acute exacerbation.~   "
80342|NCT02515305|"~     The purpose of this study is to compare the safety and efficacy of Perrigo's product to an~     FDA approved product for the treatment acne vulgaris~   "
80343|NCT02515292|"~     Purpose: Clinical assessment (anthropometric) and paraclinical (biochemical and immunological~     by dosing serum insuline growth factors IGF1 and IGF2 and their receptors) of neonates with~     intrauterine growth restriction (IUGR) and the integration in a multidimensional statistical~     model .~      Objectives:~        1. IGF1 and IGF2 evaluation of serum and IGF1 receptor, IGF2 receptor and IGF2 receptor~          gene expression in cord blood from newborns with intrauterine growth restriction (IUGR).~          (Prospective)~        2. Evaluation and monitoring of anthropometric, clinical (non-cardiac morbidity) and~          paraclinical. (Retrospective & prospective)~        3. Evaluation and monitoring of morphological and functional by echocardiography.~          (Prospective)~        4. Integrating multidimensional clinical and paraclinical parameters in a statistical model~          for evaluating newborn with intrauterine growth restriction.~   "
80344|NCT02515279|"~     This noninterventional, open-label study will observe the safety and tolerability of~     peginterferon alfa-2a in combination with ribavirin among Austrian participants treated for~     HCV infection according to routine practice.~   "
80345|NCT02515266|"~     Postnatal growth is a crucial in premature infants as it could be correlated with the~     long-term cognitive development. Optimal nutritional care is required to reduce the initial~     weight loss and further growth deficit.~      The quantitative objective is to achieve growth that is at least equivalent to that of the~     fetus (on average 15 g/kg.day (12-18 g/kg.day according to gestational age). Children often~     grow during difficult 10-15 first days of life, so they accumulate a delay that should~     compensate them secondarily. Therefore, optimum postnatal growth is rather 20 g/kg.day than~     15 g/kg.day.~      Individualized fortification of human milk (HM) has been proposed to optimize postnatal~     growth. Specifically, the lack of protein intake is responsible for sub-optimal postnatal~     growth in preterm infants.~      The objectives of this study are to determine the effectiveness of additional protein~     fortification (APF) in terms of short-term growth along with the proportion of extremely low~     birth weight (ELBW) infants requiring APF.~   "
80346|NCT02515253|"~     The purpose of this study is to assess whether prescribing a bra to participants results in~     an improvement in the Patient Global Impression of Change (PGIC) compared to participants who~     receive standard care alone.~   "
80347|NCT02515240|"~     The purpose of the study. To characterize the immune response to the pneumococcal vaccine in~     HIV positive individuals and to dissect the most appropriate timing and frequency of~     vaccination.~   "
80348|NCT02515227|"~     This study evaluates whether it is safe to administer a peptide vaccine in combination with~     pembrolizumab. This study will also evaluate the effects of the combination of the peptide~     vaccine and pembrolizumab on the immune system. The investigators will monitor these effects~     by performing tests in the laboratory on participants' blood, a lymph node, and tumor~     samples.~   "
80349|NCT02515214|"~     The use of bariatric surgery has risen subsequently over the last decade, especially in women~     of reproductive age. (Unplanned) pregnancies in this subgroup are not rare because of e.g. an~     increased fertility (because of the weight loss) and a possible ineffectiveness of~     contraceptives (because of a malabsorption in the intestine). Although a pregnancy after~     bariatric surgery is generally known as safe, there are a few studies that indicate that a~     pregnancy after a bariatric surgery is not always without complications, and that it should~     be considered as a high risk pregnancy. The research on pregnancy outcomes after this type of~     surgery is rather limited to a few small, mainly retrospective, observational case-control~     and cohort studies and a limited amount of case studies. For risk- and prognose related~     issues, e.g. the effect of bariatric surgery on fertility, timing of the pregnancy,~     development of complications during the pregnancy and pregnancy outcomes, large prospective~     cohort studies are needed. Besides, breast feeding practices and breast milk composition have~     scarcely been investigated in this population. The energy content of breast milk could~     possibly be influenced by a state of malabsorption after the procedure. Low amounts of~     vitamin B12 have also been noticed in the breast milk of women the surgery. The overall~     objective of this study is to establish a group of women at reproductive age (age 18-45) with~     a history of bariatric surgery and to generate an extensive database for future analysis. The~     final goal of the researchers is to develop guidelines or recommendations on how to manage~     pregnancies after bariatric surgery, based on large-scale prospective research.~      The study design is a multicentric observational and prospective cohort study. Participants~     will be followed from the moment of surgery until 6 months postpartum and they can be~     included on several time points (before surgery, after surgery (<12 months); after surgery~     (>12 months) or during the pregnancy). Both retrospective and prospective data concerning the~     medical background, fertility (menstrual cycle), lifestyle (e.a. food, physical activities,~     smoking, sleeping), blood samples, psychological factors (fear and depression), sexuality,~     quality of life and pregnancy outcomes will be collected. Data collection by the~     investigators will happen in a web-based database and by direct online registration by the~     subjects.~   "
80350|NCT02515201|"~     Clinical trial, that aim is evaluation of the use of taurolidine and heparin in the~     prevention of bloodstream infection in venous catheter in children with intestinal failure.~   "
80351|NCT02515188|"~     Sedation for catheter ablation of atrial fibrillation should be performed to achieve~     analgesia, immobilization, and maintenance of airway. Various anesthetic agents such as~     propofol, dexmedetomidine, and midazolam were investigated to achieve this goal. However,~     propofol and midazolam causes respiratory depression and dexmedetomidine occasionally~     accompanies hypotension or hypertension and bradycardia. Therefore, anesthetic agent that~     does not induce respiratory depression with stable hemodynamics is needed.~      Propacetamol (Denogan®, Yungjin, Seoul, Korea) is injectable prodrug of acetaminophen and 1st~     line drug for fever and pain. In a previous study, paracetamol reduced morphine consumption~     after surgery. And paracetamol does not cause respiratory depression. Thus, the investigators~     hypothesized that addition of propacetamol to previously used sedatives~     midazolam-remifentanil will reduce opioid consumption during the catheter ablation.~      Therefore, the investigators designed this study to investigate the role of addition of~     propacetamol to previous used midazolam-remifentanil sedation. This study will compare the~     opioid consumption and respiratory effect of propacetamol with placebo-control for catheter~     ablation of atrial fibrillation.~   "
80352|NCT02515175|"~     This study evaluates the reduction in viral shedding after vaccination with a new formulation~     of GEN-003 in subjects with genital HSV-2 infection. Two-thirds of the participants will~     receive GEN-003, one-third will receive placebo.~   "
80353|NCT02515162|"~     In a randomized clinical trial of 160 women undergoing conization for cervical dysplasia, two~     electrosurgical excision methods, Fischer Cone Biopsy Excison vs. Loop Excision Procedure,~     will be compared. The primary outcome of the study is dysplasia-free resection margin rate,~     secondary outcomes are intraoperative blood loss, time to complete hemostasis, intervention~     time, postoperative pain, intra- and postoperative complications, the resected cone volume~     and users satisfaction.~   "
80354|NCT02515149|"~     Randomised Controlled Trial to Assess Accuracy, Feasibility, Acceptability, Cost~     Effectiveness and Impact of Point of Care CD4 Testing on HIV Diagnosis, Linkage to Care and~     Time to Antiretroviral Therapy Initiation among HIV Infected Patients in Rural Western Kenya.~   "
80355|NCT02515136|"~     In a computerized experiment, visual stimuli will be presented to the parkinson's disease~     patients and to the controls. They will respond to each image by acting on the keyboard in a~     specific manner. Each participant will repeat that task 384 times per session. A break will~     be inserted every 12 tests so that participants can rest.~      The experiment consists of three sessions. Each image will be presented three times. For the~     first two presentations it is assumed that a link will be created between the image and the~     task, and the image and action. In the third presentation, the same task and the same action~     will be maintained or will be swapped. In this way, It can be checked whether associations~     thus generated will affect the performance of the participants when tasks and actions will be~     incongruent.~   "
80356|NCT02515123|"~     Early enteral feeding is a key component of the management of critically ill patients~     receiving mechanical ventilation. However, enteral feeding has been associated with serious~     complications such as gastro-esophageal reflux, with both overt and micro pulmonary~     aspiration, which potentially increases the risk to nosocomial pneumonia. Many critically ill~     patients experience poor tolerance of early enteral nutrition because of impaired gastric~     motility, which leads to a sequence of delayed gastric emptying, increased gastric volume,~     gastro esophageal reflux, vomiting, aspiration, and VAP. Early and adequate enteral feeding~     in ICU patients is correlated with decreased overall infections rates, ventilator and~     intensive care unit (ICU) days, costs, and mortality.~      This study is intended to assess the efficacy and safety of the E-Motion System (i.e.~     E-Motion tubeTM and E-Motion EPG 1000TM) in improving tolerance to enteral nutrition by~     inducing esophageal motion by means of electrical stimulation in ICU patients.~   "
80357|NCT02515110|"~     Single-arm, phase 2 study evaluating hypofractionated irradiation of breast and regional~     nodes in women with breast cancer. Patients will be grouped in 3 surgery-related treatment~     groups: 1) An intact breast following lumpectomy; 2) plans for loco regional external beam~     radiotherapy (EBRT) following mastectomy (with or without plans for reconstruction); and 3)~     plans for locoregional EBRT following mastectomy with reconstruction.~      Patients will be assessed for lymphedema, arm function, breast or chestwall pain, other~     EBRT-related adverse events, and, for patients who had a lumpectomy or mastectomy with~     reconstruction, cosmetic outcome.~   "
80358|NCT02515097|"~     Evaluate the safety and efficacy of a topical lotion when applied once daily to adult~     subjects with moderate to severe plaque psoriasis.~   "
80359|NCT02515084|"~     The purpose of the study is to evaluate the concordance between the 18F-PET/CT under~     thyrotropin stimulation and the diffusion-weighted Magnetic Resonance Imaging, in the~     detection of residual mass in 40 patients with partial response or relapsed differentiated~     thyroid carcinoma.~   "
80360|NCT02515071|"~     Acute consumption of dietary nitrate (as beetroot juice) has been shown to decrease systemic~     blood pressure in multiple populations as well as increase organ perfusion in areas of~     interest such as the pancreas and brain. Obstructive sleep apnoea syndrome (OSAS) is~     associated with high blood pressure, dysglycaemia and impaired vigilance. The effect of~     dietary nitrate in OSAS has not been reported.~   "
80361|NCT02515058|"~     The study is a 2-arm, parallel-design, randomized, prospective clinical trial designed to~     examine histologic wound healing following ridge preservation using bone allograft that has~     been prepared by either freeze-drying or via a non-freeze-dried solvent process.This entire~     protocol involves procedures that are standard care. All materials are FDA-approved materials~     being used in an FDA-approved manner. The test group subjects will have extraction sockets~     grafted with a cancellous non-freeze-dried bone allograft (called PUROS graft). This test~     group will be compared to an active control group using cancellous freeze-dried bone~     allograft (called FDBA). The null hypothesis is that there will be no significant difference~     in formation of new vital bone between treatment groups (primary outcome).~      Each subject will provide a single non-molar tooth site for study treatment. After tooth~     extraction, the graft material will be placed and covered by a resorbable collagen membrane.~     Following 3 months of healing, the dental implant will be place, at which time a core of bone~     will be removed from the site as part of the preparation for the implant. The core biopsy~     will then be evaluated for the primary histologic outcome of % vital bone formation and~     secondary histologic outcome of % residual graft material.~   "
80367|NCT02514980|"~     this study will be undertaken to evaluate the safety and analgesic efficacy of adding~     ketamine to bupivacaine in bilateral infra-orbital nerve block for relief of pain~     postoperatively following repair of cleft lip in children less than two years of age.~   "
80368|NCT02514967|"~     The purpose of this study is to evaluate the clinical efficacy of blisibimod as measured by a~     composite responder index in subjects who, despite corticosteroid use, continue to have~     seropositive, clinically-active Systemic Lupus Erythematosus (SLE) as defined by~     SELENA-SLEDAI score ≥10, and positive for anti-double stranded DNA and low complement (C3 or~     C4).~   "
80369|NCT02514954|"~     Each subject will be randomly allocated to a sequence of two treatments applied at two~     separate dosing visits. At each dosing visit subjects will be injected with individualised~     doses of either BioChaperone® Combo or Humalog® Mix 25 immediately before ingesting a~     standardised mixed meal [(t=0 min) start of the meal]. Insulin doses will be identical at~     both dosing visits of one individual and will be administered subcutaneously in the abdominal~     region. Subjects will be asked to consume a standardised meal (e.g. pizza) for dinner at home~     in the evening before each dosing visit. Subjects will attend the clinical site in a fasted~     state in the morning of each dosing day and stay at the clinical trial centre until 10-hour~     after dosing (standardised test-meal procedure has been terminated after 6h). The two dosing~     visits will be separated by a wash-out period of 5-15 days.~   "
80370|NCT02514941|"~     The purpose of this study is to evaluate pharmacokinetics of paracetamol, amoxicillin and~     talinolol in morbid adipose subjects before as well as shortly after and about one year after~     proximal Roux-en-Y Gastric Bypass (RYGB) and to measure messenger ribonucleic acid (mRNA)~     expression and protein content of duodenal and/or jejunal drug metabolizing enzymes (eg.~     cytochrome P450 isoenzyme 3A4 (CYP3A4), uridine diphosphoglucuronosyltransferase (UGTs)) and~     drug transport proteins (e.g. P-glycoprotein, MRP2, OATPB, PEPT) before and during the~     operation and about one year after proximal RYGB.~   "
80371|NCT02514928|"~     This study is performed to confirm whether resection of the nerve plexus on the right half of~     celiac and SMA associated with extended pancreatoduodenectomy could improve survival and~     relieve pain of pancreatic cancer patients.~   "
80372|NCT02514915|"~     The primary goal of this research study is to determine the efficacy of giving pre-operative~     radiosurgery to patients pending resection of a brain metastasis.~   "
80373|NCT02514902|"~     In the search for a novel marker of stroke that could be rapidly assessed in blood, the~     investigators developed a point-of-care (POC) lateral flow device (LFD) that rapidly (< 15~     min) detects levels of a biomarker that is released into blood following neuronal injury~     associated with stroke and traumatic brain injury. The protein's expression in human brain~     should serve as a useful biomarker of neuronal injury in stroke and traumatic brain injury.~   "
80374|NCT02514889|"~     Investigators from the University of California-Los Angeles (UCLA) and The Children's Clinic~     of Long Beach (TCC) are conducting a randomized, controlled comparative effectiveness trial~     of two government-sanctioned behavior change approaches to weight control with TCC's obese~     patients. The first approach is the calorie-counting calorie restriction (CC) approach used~     in the Diabetes Prevention Program. The second approach is the high-satiation/high-satiety~     approach represented by MyPlate.gov. The MyPlate nutritional goal is to double patient fruit~     and vegetable intake, legume intake, and whole grain intake. Both conditions stipulate 150~     minutes of moderate physical activity a week. Study participants will be 300 of TCC's obese~     patients, 76% of whom are expected to be Latino, 13% African American and 11% Other~     Ethnicities.~      The interventions will be implemented by trained community lifestyle change coaches with~     brief support from clinicians. The interventions will include two home visits, two group~     education sessions and seven telephone behavior change coaching sessions.~      Compared to the CC approach, the MyPlate approach is hypothesized to yield better 12 months~     patient-centered outcomes, particularly self-reported satiety.~   "
80375|NCT02514876|"~     This study will evaluate the efficacy of 2D forward-looking and 3D Intracardiac~     Echocardiography (ICE) to guide septal punctures during Atrial Fibrillation ablation~     procedures.~   "
80376|NCT02514863|"~     Electrical velocimetry (EV) is one of the latest adaptions of impedance cardiography showing~     diverging results. With electrode position being a suspected factor influencing measurement~     accuracy or reproducibility for impedance cardiography in general, no data is currently~     available on altering the gap of the two lower electrodes in EV. Reference values were~     determined using the non-invasive gold-standard cardiac magnetic resonance imaging (CMR).~   "
80377|NCT02514850|"~     This is a single centre, randomised, double-blind, double-dummy, 3-treatment, 3-period~     cross-over, euglycaemic clamp study in subjects with type 2 diabetes on stable insulin~     treatment. Each subject will be randomly allocated to a treatment sequence and will be~     administered single subcutaneous doses of 0.8 U/kg Biochaperone® Combo, 0.8 U/kg Humalog®~     Mix25 or simultaneous subcutaneous injections of 0.2 U/kg Humalog® and 0.6 U/kg Lantus®~     during three separate dosing visits.~   "
80378|NCT02514837|"~     A malignant tumor has higher temperature than normal tissue and the temperature of the tumor~     is dependent on the tumor growth rate. Thus tumor temperature is the universal indicator of~     tumor activity.~      The temperature changes begin in the stage of atypical hyperplasia and increased~     proliferation and this opens up the possibilities for detection of patients with high risk~     lesions.~      Microwave radiometer (RTM-01-RES) allows measurement of temperature changes of internal~     tissue at the depth of several centimetre and allows visualization of the temperature on the~     thermogram and temperature field.~      It is noninvasive and the measurement of internal temperature is based on receiving natural~     electromagnetic radiation from the tissue in the gigahertz (GHz) frequency range. The device~     is absolutely harmless and has no risk because it does not emit any radiation. It can be used~     repeatedly as a method of monitoring.~      Microwave radiometry has successfully completed seven clinical trials of more than 1000~     patients in different countries. Microwave device (RTM-01-RES) is used in more than 300~     medical centers in 30 countries.~      Medical technology of microwave radiometry is included in the nomenclature of medical~     services in the Russian Federation, the Ministry of Health and is part of the standard of~     care for patients with malignant tumors of the breast.~      This method of microwave radiometry is recommended by leading Russian mammalogists in the~     National guidelines of breast care.~      The investigators would like to use the device in clinics in Scotland and later United~     Kingdom (UK) for breast diagnosis and monitoring treatment.~      During 3 months the investigators aim to examine 150 patients with breast cancer and 150~     patients without cancer who will be the control group. The results of temperature measurement~     will be compared with the results of histology, in particular, tumour cellulants p53~     expression and other gene expression data for metabolic biomarkers and other tumor indicator.~     Statistical analysis of data will be performed. The device and initial training will be~     provided by RES Company (device producer).~   "
80379|NCT02514824|"~     This research study is studying a targeted therapy as a possible treatment for merkel cell~     carcinoma.~      - The name of the study intervention involved in this study is: MLN0128.~   "
80380|NCT02514811|"~     The Northwest Coalition for Adolescent Health (NWCAH) replicated the Teen Outreach Program~     (TOP) in five states across the pacific northwest including Idaho, Alaska, Montana, Oregon,~     and Washington. The purpose of this study is to measure: at the end of the program year, were~     TOP students less likely than control group students to report ever being pregnant or causing~     someone to be pregnant?~   "
80381|NCT02514798|"~     Patients affected with severe parenchymal pulmonary diseases, such as Chronic Obstructive~     Pulmonary Disease (COPD ), may experience dyspnea at rest due to increased work of breathing~     and reduced oxygenation. The delivery of high-flow humidified nasal oxygen (HFNC) has been~     shown to have a positive-end-expiratory pressure (PEEP) effect and is able to flush out CO2~     from the upper airways, reducing dead space ventilation. Furthermore it has been proven to~     reduce the respiratory rate shortly after its initiation. These multiple actions offer the~     potential of changing the respiratory pattern and reducing work of breathing, improving the~     efficiency of breathing.~      In this short-term, physiological, open, randomized, cross-over pilot study the investigator~     swill describe the effects of varying settings of high-flow nasal oxygen on respiratory rate,~     tidal volume, and diaphragmatic work of breathing in patients with severe COPD. The~     investigators will also describe changes in gas exchange and effects on the subjects' comfort~     and dyspnea and the breathing responses to varying setting of CPAP in the subject population.~   "
80382|NCT02514772|"~     The study objective is to identify potential safety risks of the transition from US-licensed~     Rituxan® or EU-approved MabThera® to GP2013 (proposed biosimilar product) as compared to~     continuous treatment with the originator product in terms of general safety and~     immunogenicity.~   "
80383|NCT02514759|"~     The Women's Clinic of Kansas City (TWC) replicated the Teen Outreach Program (TOP) across~     Kansas City, Missouri. The purpose of this study is to measure: one year after the end of the~     program year, what is TOP's impact on the treatment group's sexual activity and contraceptive~     use, relative to the control group, at one year following the program?~   "
80384|NCT02514746|"~     This study aims to understand the persistence of the Japanese encephalitis (JE) antibody~     response in previously vaccinated children. The proposed study is a phase 4 open-label trial~     enrolling up to 818 Bangladeshi children who had previously participated in a lot to lot~     consistency study (JEV05) of JE live attenuated SA 14-14-2 vaccine (CD-JEV).~   "
80385|NCT02514733|"~     This is a single center study that seeks to study the impact of donor age on recipient~     outcomes in older kidney transplant recipients.~   "
80386|NCT02514720|"~     The purpose of this study is to investigate the effects of nicotine metabolism on occupancy~     of [11C]-(+)-PHNO to DA 2/3 receptors in different brain areas during periods of abstinence~     and smoking during an abstinence. This will be a Positron Emission Tomography (PET) study and~     the radiotracer [11C]-(+)-PHNO (11C]-( + )-4-propyl-~     3,4,4a,5,6,10b-hexahydro-2H-naphtho[1,2-b][1,4]oxazin-9-ol) will be used.~   "
80387|NCT02514707|"~     Study Title: Outcomes of HIV infected individuals after ten years on antiretroviral treatment~     Short Title/Study ID: ALT cohort Protocol Version and Date: Version 1.0 June 2013 Clinical~     Phase: NA Methodology: Prospective observational study Study Duration: 01 January 2014- 30th~     June 2025 Study Centre(s): Single centre (Infectious Diseases Institute, Kampala, Uganda)~     Number of Subjects: Enrollment of 1,000 study participants. All patients discharged from the~     IDI Research cohort (10 years of follow up on ART) will be offered to participate in the~     study. Additional patients with similar characteristics will be enrolled from he clinic~     Diagnosis and Main Inclusion Criteria: HIV patients above 18 years and in their 10th year of~     ART Main Exclusion Criteria: ART started outside IDI Study Product, Dose, Route, Regimen: ART~     will be provided according to standard of care at IDI and according to the WHO and Ugandan~     guidelines Duration of follow up: 10 years Reference therapy, Dose, Route, Regimen: Not~     applicable Recruitment Schedule: 1 January 2014- 30 June 2015 Statistical Methodology: Time~     to event analysis (end of treatment, failure, death, switch, occurrence of drug toxicities)~     including Kaplan-Meier curves and Cox regression will be performed. Endpoints will be~     correlated with characteristics at ART start and at study enrollment. Possible confounding~     variables, if available, will be considered.~      GCP Statement: This study will be conducted in compliance with the protocol, the current~     version of the Declaration of Helsinki, and ICH-GCP as well as all national legal and~     regulatory requirements.~   "
80388|NCT02514694|"~     LEO 32731 (Study Drug) is an investigational drug which is being developed by LEO Pharma~     A/S (the Sponsor) for treatment of psoriasis. The aim (s) of this Study are to determine:~        -  The safety and tolerability of the Study Drug and any side effects that might be~          associated with it~        -  The Study will also measure how much of the Study Drug that gets into the blood and how~          long time it takes for the body to remove it.~   "
80389|NCT02514681|"~     The purpose of this study is to evaluate the efficacy and safety of pertuzumab, trastuzumab~     and chemotherapy as a pertuzumab retreatment compared to trastuzumab and chemotherapy in~     locally advanced or metastatic breast cancer patients for previously treated with pertuzumab~   "
80390|NCT02514668|"~     Primary Objective:~        -  Part A: To evaluate the safety of SAR650984 (isatuximab) in patients with~          relapsed/refractory multiple myeloma (RRMM).~        -  Part B: To evaluate the activity of SAR650984 (isatuximab) as assessed by overall~          response rate (ORR) in RRMM patients previously treated with daratumumab.~      Secondary Objectives:~        -  Part A:~        -  To determine the pharmacokinetics (PK) of SAR650984 (isatuximab) in patients with RRMM.~        -  Part B:~        -  To evaluate the safety of SAR650984 (isatuximab).~        -  To evaluate the efficacy of SAR650984 (isatuximab) as assessed by duration of response~          (DOR), clinical benefit rate (CBR) and progression free survival (PFS).~        -  To assess the pharmacokinetics (PK) of SAR650984 (isatuximab) and daratumumab at~          baseline.~        -  To evaluate the immunogenicity of SAR650984 (isatuximab).~   "
80391|NCT02514655|"~     Hypothesis: Nosten® device is able to reduce the time of underinflated balloon and removes~     excess pressure. This device may thus reduce the risk of ventilator-acquired pneumonia (VAP)~     and early tracheal lesions resulting from intubation with decreased discomfort, morbidity,~     and nursing workload.~      The main objective of the investigators is to show that Nosten® device is more effective than~     monitoring and manual inflation of the balloon of the tracheal tube to prevent VAP~     occurrence.~   "
80392|NCT02514642|"~     Ticagrelor is an oral, reversibly-binding, direct-acting P2Y12 receptor antagonist used~     clinically for the prevention of atherothrombotic events in patients with acute coronary~     syndromes (ACS). Guideline recommendations on the use of dual antiplatelet therapy (DAPT)~     have been formulated that ticagrelor 90 mg twice daily plus aspirin in preference to~     clopidogrel 75mg daily plus aspirin for patients who have an ACS with or without ST-segment~     elevation. However, few East Asian patients (or those of East Asian descent) have been~     included in these trials to assess the use of these drugs. In Korea and Japan, it has been~     reported that low doses of ticagrelor might have a more potent inhibition of platelet~     aggregation (IPA) than clopidogrel (75 mg once daily) in healthy subjects and patients with~     stable coronary artery disease, respectively. But it is still not clear whether a low dose of~     ticagrelor is superior to clopidogrel in a large population of Chinese ACS patients. A recent~     study on pharmacokinetics and tolerability of ticagrelor has found that maximum plasma~     concentration and area under the plasma concentration-time curve of ticagrelor (90 mg twice~     daily) and its active metabolite (AR-C124910XX) tended to be approximately 40% higher in~     healthy Chinese volunteers compared with Caucasian subjects. This data also suggested that a~     low dose of ticagrelor might be more appropriate for Chinese ACS patients. In view of a large~     diurnal variation with a single daily dose, a lower dose twice daily may be a better choice~     for Chinese patients. Therefore, the investigators performed this randomized, single-blind,~     crossover clinical trial to observe the efficacy and safety of low-dose ticagrelor (22.5 mg~     twice daily) in comparison to clopidogrel (75mg once daily) in Chinese patients with stable~     coronary artery disease.~   "
80393|NCT02514629|"~     The purpose of this study is to examine the effects of metformin, testosterone, or both, in~     males with obesity-related hypogonadism. This study will evaluate changes in insulin~     resistance, weight loss, body composition, testosterone levels,quality of life and erectile~     dysfunction.~      Obese men will receive diet and physical activity counselling, and be randomised to either~     testosterone, metformin, a combination of both or placebo~   "
80394|NCT02514616|"~     The investigational device that will be used in this trial is the EndoStim® Lower Esophageal~     Sphincter (LES) Stimulation System.~      The purpose of this trial is to evaluate the safety and the effectiveness of electrical~     stimulation therapy (EST) on the lower esophageal sphincter (LES) in the treatment of~     subjects with gastroesophageal reflux disease (GERD).~      The study population will consist of subjects diagnosed with pathological GERD as defined by~     abnormal pH and who complain of heartburn, regurgitation or both for > 6 months, on a daily~     PPI use.~   "
80395|NCT02514603|"~     The primary purpose of this study is to assess the tolerability of prexasertib in Japanese~     participants with advanced solid cancers.~   "
80396|NCT02514590|"~     The purpose of this study is to assess the effectiveness of the Stimwave Spinal Cord~     Stimulator (SCS) System for treatment of chronic pain utilizing high frequency (10,000 Hz)~     waveforms in comparison to traditional stimulation settings.~   "
80397|NCT02514577|"~     Evaluate the safety and efficacy of a topical lotion when applied once daily to adult~     subjects with moderate to severe plaque psoriasis.~   "
80398|NCT02514564|"~     This study evaluates the effects of different volumes of aerobic exercise training in~     cardiovascular parameters of patients with cardiovascular diseases enrolled in a cardiac~     rehabilitation program.~   "
80399|NCT02514551|"~     The main purpose of this study is to evaluate the efficacy of an alternative dose of~     ramucirumab in combination with paclitaxel in participants with second-line metastatic or~     locally advanced, unresectable gastric or gastroesophageal junction adenocarcinoma (GEJ).~   "
80400|NCT02514538|"~     Paracetamol's solubility is achieved by adding to the excipient sodium salts, either as~     bicarbonate, carbonate or citrate. As the relationship between salt and hypertension is well~     known, due to the sodium content it has raised a hypothesis that may interfere with the~     control of that risk factor.~      Therefore, the objective of this study is to evaluate the effect on blood pressure of~     effervescent paracetamol compared to non-effervescent, in hypertensive patients.~      This is a multicenter, randomized, controlled, crossover, open, phase IV clinical trial,~     which compares the effect of two different formulations of paracetamol (effervescent or~     non-effervescent tablets) in the blood pressure of hypertensive patients after 3 weeks~     treatment (coded EUDRACT 2010-023485-53). The washing time between the two periods is~     approximately 1 week (minimum 3 days)~   "
80401|NCT02514525|"~     To evaluate the efficacy and safety of the CryoBalloon Focal Ablation System for the~     treatment of previously-untreated (treatment naïve) Barrett's Esophagus (BE)~   "
80402|NCT02514512|"~     A research study into a new technology for adjustment of the radiotherapy beam to account for~     movement of lung tumours as the patient breathes during radiotherapy.~   "
80403|NCT02514499|"~     The overall goal of the proposed research is to evaluate the uptake of testing and~     longitudinal risks and benefits of multiplex testing for cancer susceptibility in BRCA1/2~     negative patients. This model will inform the selection of the outcomes and potential~     mediators and moderators of these outcomes, to inform the debate over utility, risks, and~     benefits of clinical incorporation of multiplex testing for breast cancer susceptibility.~   "
80404|NCT02514486|"~     This study will describe patient-reported symptom burden and concerns, quality of life (QOL),~     and health behaviors of breast cancer(BC) survivors who have completed initial treatments~     (e.g., surgery, chemotherapy, and/or radiotherapy), assess the feasibility of using a~     web-based platform to collect patient-reported outcome (PRO) data, and evaluate provider~     satisfaction following delivery of an electronic health record (HER)/EPIC summary of these~     PROs. Secondary aims will estimate differences in referral to available services between~     those providers exposed to the PRO summary and historical controls. BC survivors who have~     completed initial treatment and present within the first year following treatment for an end~     of treatment (EOT)/survivorship focused visit will be the focus of this study.~   "
80405|NCT02514473|"~     To evaluate the efficacy and safety of lumacaftor in combination with ivacaftor in subjects~     aged 6 Through 11 years with cystic fibrosis (CF), homozygous for the F508del CF~     transmembrane conductance regulator (CFTR) mutation~   "
80406|NCT02514460|"~     This is a randomized study comparing stent and plaque excision systems in treatment of lower~     limb (superficial femoral or popliteal artery) ischemia.~   "
80407|NCT02514447|"~     This is a study to investigate the potential clinical benefit of trilaciclib (G1T28) in~     preserving the bone marrow and the immune system, and enhancing chemotherapy antitumor~     efficacy when administered prior to topotecan in patients previously treated for~     extensive-stage SCLC.~      The study consists of 2 parts: a limited open-label, dose-finding portion (Part 1), and a~     randomized double-blind portion (Part 2). Both parts include 3 study phases: Screening Phase,~     Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first~     dose with study treatment and completes at the Post-Treatment Visit. The open-label portion~     enrolled 32 patients and the randomized portion will enroll approximately 90 patients.~   "
80408|NCT02514434|"~     The investigators will investigate the usefulness of ultrasonography versus non-contrast~     magnetic resonance imaging for surveillance of hepatocellular carcinoma through this~     prospective, randomized trial.~   "
80409|NCT02514421|"~     The purpose of this study is to see how well electrochemotherapy works at treating people~     with Stage III pancreatic adenocarcinoma. Electrochemotherapy is a treatment that combines~     electroporation and chemotherapy administration. Electroporation uses an electric current to~     produce holes in pancreatic tumor, which causes the tumor cells to die or take up a higher~     concentration of administered chemotherapy agent. This study will test the safety and look at~     the effect of electrochemotherapy in the treatment of stage III pancreatic adenocarcinoma.~     This study will also help to find the safest and most effective amount of electroporation~     voltage to apply to this type of tumor.~   "
80410|NCT02514408|"~     This pilot clinical trial studies the impact of radical cystectomy (surgery) on the expulsion~     (release) of circulating tumor cells into the blood stream in patients with bladder cancer.~     Significant surgery such as radical cystectomy may cause the expulsion of tumor cells.~     Studying the release of tumor cells into the circulation may help doctors understand the~     impact that radical cystectomy has on tumor metastasis and/or tumor recurrence.~   "
80411|NCT02514395|"~     Background:~      KOOS is a self -administered instrument which assesses the patient's opinion about the Knee~     associated problems. For now it is available in English & various other languages & is a~     complete instrument in itself.~      In India it has been translated in Hindi so far. However, each province in this country has a~     unique language. Maharashtra is the second largest state in India and Marathi is the regional~     language of the communication. Since KOOS is a self‐report measure, its translation in this~     local language was thought to be necessary. This disease specific measure which is originally~     designed for English speaking region when employed to non-English population needed to be~     translated with unique method to achieve a normative equivalence and linguistic validation.~      Methods: After taking permission from KOOS web manager T1, T2, T12, B1 & B2 versions were~     formatted according to the guidelines laid down by AAOS for cross cultural adaptation of~     health status measure. T12 version was sent for the field testing. Total 32 subjects who met~     the eligibility criteria were Included in this study.~      Results:~      Statistical analysis for reliability with test re‐test method suggested Perfect correlation~     (r =1) between day 1 & 2. A range of 0.83‐0.54 co‐relation co‐efficient (r) demonstrated the~     validity of KOOS and its subscales when compared against the 8 different domains of SF‐36.~     All this correlations were statistically highly significant. Sport and recreation subscale~     had many missing responses since many items in this subscale were not appropriate for the~     Maharashtrian cultural set-up. Participants additionally provided the information about other~     functional activities which were difficult to execute due to knee associated pain and~     disability.~      Conclusion: Marathi version of KOOS is proved to be a reliable & valid measure. Future scope:~     this study demonstrate a need to undertake the cross cultural adaptation since a constant~     pattern of impairment revealed in the execution of daily activities such as sitting on the~     floor and attending certain yoga postures etc.~      Key words: linguistic validation, disease specific self-report, KOOS, Marathi translation,~     quality of life.~   "
80412|NCT02514382|"~     This phase Ib trial studies the safety and best dose of wild-type reovirus in combination~     with bortezomib and dexamethasone and to see how well they work in treating patients with~     multiple myeloma that has returned (relapsed) or does not respond to treatment (refractory).~     A virus, called wild-type reovirus, may be able to infect cancer cells and slow the cancer~     growth and kill cancer cells. Bortezomib and dexamethasone may stop the growth of cancer~     cells by blocking some of the enzymes needed for cell growth. Giving wild-type reovirus~     together with bortezomib and dexamethasone may be a better treatment for multiple myeloma.~   "
80413|NCT02514369|"~     Some genetic polymorphisms are known to interfere with ARV metabolism and are therefore~     likely to explain some of the inter-individual variations (efficacy,toxicity,resistance)~     observed during ART. The most common form of human DNA variations consists of a change of a~     base in the nucleotide sequence of an individual at a given position, the single nucleotide~     polymorphism (SNP). Therefore,the purpose of this research will be the identification and~     characterization of the clinical impact of several SNPs in gene coding for transport proteins~     (e.g.ABCB1,ABCC1) and biotransformation enzymes (e.g.CYP3A4,CYP2B6) known to be involved in~     the pharmacokinetic pathway of selected ARV drugs for which the therapeutic response is~     difficult to predict. Aside,the influence of these SNPs on the response to treatment~     (CD4+cell,viral load) and on the toxicity will be evaluated. Plasma concentrations of ARV~     drugs correlate with therapeutic efficacy but also with the risk of toxicity and of~     virological failure, which is the basis of the therapeutic drug monitoring. However,given the~     intracellular location of HIV, analyzing intracellular drug concentrations is fundamental and~     the investigators will also focus of this new topic.~   "
80414|NCT02514356|"~     The purpose of this study 'SMS as an Incentive To Adhere' (SITA) is to test two novel~     approaches of using SMS messages (provision of information about electronically measured own~     adherence, as well as in combination with group adherence level) to improve adherence to~     anitretroviral (ART) and pre-ART prophylaxis among youth age 15-24 at an HIV clinic in~     Uganda.~   "
80415|NCT02514343|"~     This study evaluates the effect of 10% magnesium sulfate in the rehabilitation of the wrist~     mobility in patients with distal radius fracture treated with percutaneous pinning and~     plaster~   "
80416|NCT02514330|"~     The objective of the present study was to determine the effect of interval session running at~     high intensity with 1% or 10% gradient on the height of the drop jump. The cinematic~     variables concentric phase, eccentric and contact time were compared after the running~     session in both conditions in order to explain possible changes in the jump performance. The~     investigators theorize that the lower eccentric overload in the running to 10% inclination~     promotes higher deleterious effect on power performance of the lower limbs~   "
80417|NCT02514317|"~     The objective of the study is to evaluate in patients suffering from carpal tunnel syndrome~     resistant to medical treatment, clinical course after percutaneous treatment under ultrasound~     guidance. 40 patients will be included in the study. The following parameters will be~     evaluated: patient satisfaction, pain, functional disability, quality of life and time to~     return to work. The medico-economic aspect will be analyzed.~   "
80418|NCT02514304|"~     The purpose of this multicenter, two component observational and standardized case-control~     study is to evaluate risk factors of gastrointestinal (GI) bleeding with a prospective~     3-month and 12-month follow-up to examine outcomes and their possible causes.~   "
80419|NCT02514291|"~     The purpose of the study is to develop and evaluate a sleep intervention program for~     improving sleep and health in youth with epilepsy and their parents.~   "
80420|NCT02514278|"~     Standard treatment of rectal cancer is rectal excision with neoadjuvant radiochemotherapy. A~     new concept suggests organ preservation as an alternative to rectal excision in good~     responders after neoadjuvant radiochemotherapy to decrease surgical morbidity and increase~     quality of life. The rational is the fact that 15% of patients have sterilized tumours after~     radiochemotherapy for T3T4 rectal cancer. The French GRECCAR 2 trial is the first phase III~     trial investigating this strategy: patients with T2T3 low rectal carcinomas (size ≤4 cm)~     received 50 Gy with capecitabine and good clinical responders (≤2 cm) were randomized between~     local and rectal excision. The main findings were: the rate of complete pathologic response~     was higher after radiochemotherapy for small T2T3 than for T3T4 tumours (40% vs 15% ypT0) and~     good pathologic responders (ypT0-1) were associated with zero positive mesorectal nodes.~      The objective of the new trial is to increase the proportion of patients treated with organ~     preservation by optimizing tumour response. As compared to Folfiri, tritherapy Folfirinox has~     been shown to enhance the response rate. In patients with colorectal metastases, response~     rate and R0 resection were twice higher, resulting in improved survival. Folfirinox also~     increases response and chance of R0 resection rates in initially unresectable colorectal~     metastases, compared to standard or intensified bi-chemotherapy regimens. Adding two months~     of neoadjuvant chemotherapy (Folfirinox) before radiochemotherapy, the investigators expect~     to increase chance of organ preservation rate, as compared to radiochemotherapy alone.~   "
80421|NCT02514265|"~     This study is the second phase of the MAPP Network and is designed to conduct a prospective,~     observational study of men and women with UCPPS, referred to as the Symptom Patterns Study~     (SPS), enriched with pre-defined subgroups, with longer follow-up, in order to further~     investigate clinical and biologic factors associated with worsening and/or improvement of~     reported urinary and non-urinary symptoms.~   "
80422|NCT02514252|"~     The goal of this clinical research study is to learn if an investigational dose of fentanyl~     sublingual spray (FSS) can help to control pain in patients with advanced cancer when given~     in an outpatient and inpatient setting.~   "
80423|NCT02514239|"~     The primary objective of this trial is to determine the maximum tolerated dose (MTD) of BI~     836909 administered by continuous i.v. infusion in patients with relapsed and/or refractory~     multiple myeloma. If the MTD is not reached based on safety findings, a recommended dose for~     further development will be determined. This will depend on the safety data,~     pharmacokinetic/pharmacodynamics data and potentially preliminary efficacy data. Secondary~     objectives are to document the safety and tolerability of BI 836909, to perform~     pharmacokinetic and pharmacodynamic analyses and to evaluate relevant biological effects in~     terms of parameters of efficacy.~   "
80424|NCT02514226|"~     Background: Association between periodontal disease (PD) and chronic obstructive pulmonary~     disease (COPD) has been widely studied and the aspiration of periodontal pathogens is one of~     the most accepted causal mechanisms for pulmonary exacerbation. Bronchiectasis is clinically~     quite similar with COPD, including chronic administration of antibiotics, increased systemic~     inflammation and relatively similar clinical symptoms, but for the time being; there are no~     studies that have correlated this condition to PD. This study will evaluate if the scaling~     and root planning (SRP) associated with photodynamic therapy improves periodontal clinical~     parameters, halitosis, and the quantity of microorganisms associated with exacerbation of~     bronchiectasis in saliva, subgingival periodontal microenvironment, sputum and nasal lavage~     at baseline, after 3 months and one year of SRP. Methods/Design: Ninety patients with chronic~     periodontal disease and bronchiectasis will be enrolled in the study and they will be treated~     as follow:G1 control (n = 30) - supragingival scaling (SS) and dental hygiene orientation~     (DHO); G2 experimental (n = 30) - SRP + DHO; G3- experimental (n = 30) - SRP + PDT + DHO. The~     quantification of bacterial groups commonly associated with exacerbation of bronchiectasis (P~     aeruginosa, S. aureus) and periodontal diseases (P. gingivalis), will be evaluated in~     periodontal pockets, saliva, nasal lavage and sputum by quantitative PCR at baseline 3 months~     and one year after the SRP. G1 patients will receive SRP upon completion of the~     investigation. If the mean depth of probing of this group worsen (> 1mm) at 3 months they~     will be excluded from the study, treated (SRP) and the data will be described. Discussion:~     The results of this protocol will determine the efficacy of periodontal treatment in~     decreasing the total amount microorganisms in saliva periodontal pocket, sputum and nasal~     lavage, the most probable niches of bronchiectasis exacerbation, and reducing local~     inflammation and halitosis after 3 months and one year. It is expected an higher improvement~     in all parameters measured over 3 months and 1 year for G3~   "
80425|NCT02514213|"~     This is a phase I, open-label trial to evaluate the safety and immunogenicity of INO 5150~     alone or in combination with INO-9012 when delivered intramuscularly (IM) followed by~     electroporation (EP) in men with biochemically relapsed prostate cancer.~   "
80426|NCT02514200|"~     The purpose of this study is to determine whether individualized, topography-based corneal~     crosslinking for keratoconus can improve the optical outcomes of the treatment.~   "
80427|NCT02514187|"~     The purpose of this study is to evaluate technetium-99m (99mTc) pertechnetate produced by a~     cyclotron as a replacement for 99mTc pertechnetate obtained from a generator containing the~     parent isotope Molybdenum-99 (99Mo). 99mTc pertechnetate is currently used in nuclear~     medicine departments across the country. 99Mo is produced by a number of ageing nuclear~     reactors across the world and severe shortages of the isotope have occurred in the past few~     years. Cyclotron-produced 99mTc offers an alternative decentralized production method on a~     regional basis. Since the manufacturing process is different, the safety and efficacy of~     cyclotron-produced 99mTc pertechnetate must be evaluated in human subjects to enable its~     routine clinical use.~   "
80428|NCT02514174|"~     Continuous treatment until progression or occurence of intolerable Adverse Event (AE) or end~     of trial. The end of trial is one year after the last patient has entered the study.~   "
80429|NCT02514161|"~     The aim of this study is to assess if an intervention of manual therapy and motor control~     exercises combined with an inspiratory muscle training program is more effective than an~     inspiratory muscle training program alone in increasing the maximum inspiratory pressure in~     moderate smokers. In addition, the study pretends to evaluate the changes caused by the~     intervention regarding possible postural changes and thoracic diameter.~   "
80430|NCT02514148|"~     The purpose of this study is to know wich combination of treatments are the most effective in~     patients with chronic migraine. The study design is a simple blind randomized controlled~     trial (outcomes assessor). The study population: Men and women aged from 18 to 70 years old~     with chronic migraine for at least 12 weeks. Interventions: A combination of techniques~     during 6 weeks (6 sessions; 1 per week)~   "
80433|NCT02514109|"~     The diagnosis of sensory neuronopathy is difficult to establish because the only certainty~     criterion is based on the detection of specific lesions in the posterior spinal ganglion~     which is usually not possible. There is to date no clinical and electrophysiological criteria~     or validated biomarker for the diagnosis of this type of neuropathy. In a retrospective~     study, we analyzed the files of patients with peripheral sensory neuronopathy certain and~     established clinical and electrophysiological diagnostic criteria for sensitive neuronopathy.~     We therefore wish now validate these criteria and investigate possible associated antibodies~     on a prospective cohort of patients.~   "
80434|NCT02514083|"~     Background:~        -  Chronic lymphocytic leukemia (CLL) and/or small lymphocytic lymphoma (SLL) are tumors of~          abnormal B cells that often affect elderly patients. Studies have identified critical~          factors required for the growth of CLL cells. First, CLL cells survive because they~          receive signals through the B-cell receptor. Second, CLL cells benefit from interactions~          with other cells, especially T cells.~        -  Survival signals through the B-cell receptor can be reduced with ibrutinib, which is a~          pill taken daily by mouth. Ibrutinib has been approved by the U.S. Food and Drug~          Administration to treat CLL patients.~        -  T cells that interact with CLL cells can be removed by fludarabine, which is a drug~          given by vein and has been widely used to treat CLL. By adding a short course of~          fludarabine, we hope to complement the action of ibrutinib and restore a healthier~          immune system.~      Objectives:~      - To determine if ibrutinib and a short course of fludarabine can be used safely and~     effectively to treat CLL or SLL.~      Eligibility:~        -  Diagnosed with CLL or SLL requiring treatment~        -  No prior treatment for CLL or SLL~        -  Age greater than or equal to 18 years~        -  Not pregnant or breast-feeding women~        -  Adequate kidney and liver function~      Study Design:~        -  This is a phase II study of 32 patients.~        -  Participants will be screened with blood tests and physical exam for eligibility.~        -  Eligible participants will be treated with ibrutinib and a short course of fludarabine;~             -  Treatment is given in cycles. Each cycle is defined as 28 days. Treatment continues~               as long as it is effective and safe for participants.~             -  Ibrutinib is taken by mouth starting on the first day of cycle 1. Ibrutinib is~               continued daily.~             -  Fludarabine is given through vein on the first five days of cycle 3 and 4 only.~               Each infusion takes approximately 30 minutes.~             -  Participants will also take drugs that prevent infections and other complications.~        -  Participants under treatment will have clinic visits with tests including:~             -  Medical history~             -  Physical exam~             -  Blood and urine tests~             -  CT and PET scans: They will lie in a machine that uses a computer to take serial~               images of the body.~             -  For the PET scan, a radioactive sugar is injected into a vein for clear~               visualization of the body.~             -  EKG: To assess heart rhythm.~             -  Bone marrow and lymph node biopsies~        -  Participants should avoid grapefruit, Seville oranges, and grapefruit juice during the~          study. They also should avoid any live vaccines.~   "
80435|NCT02514070|"~     Background:~      - Metabolism is what the body does to turn food into energy. Omega-3 fatty acids are~     substances found in foods such as cold-water fish and shellfish that are essential for good~     health. Researchers want to see the effect of two fatty acids eicosapentaenoic acid (EPA) and~     docosahexaenoic acid (DHA) on metabolism. They may be beneficial to cardiovascular health.~      Objective:~      - To understand the effects of EPA and DHA on metabolism.~      Eligibility:~      - Healthy people ages 18 years or above with plasma triglyceride (a type of fat in the blood)~     levels of 100 mg/dL or higher~      Design:~        -  The study will last 20 to 24 weeks.~        -  Participants will have 4 visits to the NIH Clinical Center. These will include:~        -  Medical history~        -  Physical Fasting blood and urine tests~        -  CAVI tests: blood pressure is taken in the arms and legs, and the heart is monitored.~        -  Participants will take an EPA/DHA dietary supplement. They will take 4 gel capsules, 3~          times a day, for 6 or 7 weeks. Then they will not take the capsules for 8 to 10 weeks (a~          wash-out period). They will then take the capsules again for 6 or 7 weeks.~        -  Participants will keep a food journal.~   "
80436|NCT02514057|"~     Assessment of a new gastrointestinal symptom questionnaire in comparison to 2 well~     established and validated questionnaires that do not fully fit the requirements of an~     investigator concerned about gastrointestinal side effects in a patient without primary~     gastrointestinal disease.~   "
80437|NCT02514044|"~     The proposed study aims to evaluate safety and efficacy of combined dextroamphetamine~     (Dexedrine) and transcranial direct current stimulation with melodic intonation therapy for~     treatment of aphasia after stroke. The target population is patients with chronic speech~     deficits due to a left hemisphere non-hemorrhagic stroke. Findings from this proposed project~     will help in the design of future larger studies.The safety phase will use cross-over,~     placebo controlled and single-blinded design. 10 participants with post stroke chronic~     non-fluent aphasia will undergo two experiments. To study the safety and effect of combined~     dextroamphetamine, tDCS and MIT therapy the study will use a parallel-groups, randomized,~     sham and placebo controlled, and double-blinded design in which 48 participants with post~     stroke chronic non-fluent aphasia will be randomly assigned to receive either 1)~     dextroamphetamine therapy with active stimulation, 2) placebo medication with active~     stimulation, 3) dextroamphetamine therapy with sham stimulation or 4) placebo medication with~     sham stimulation for the same duration.~   "
80438|NCT02514031|"~     This is a study of ARQ-761 (beta-lapachone) with gemcitabine/nab-paclitaxel chemotherapy in~     subjects with advanced (metastatic, unresectable, or recurrent) pancreatic cancer that has~     not been treated with gemcitabine.~   "
80439|NCT02514018|"~     The re-activating nature of Varicella Zoster Virus (VZV) may allow life long boosting when~     used as a vaccine vector in conjunction with HIV to generate durable immunity systemically~     and at the mucosa. This study aims to characterize mucosal immunity before and after~     vaccination with a commercial live-attenuated varicella-zoster virus vaccine with respect to~     immune activation state, mucosal homing properties and VZV-specific effector immune responses~     in healthy women at low risk for HIV acquisition.~   "
80440|NCT02514005|"~     It is a randomized clinical trial comparing two treatments in patients affected by the~     patellofemoral syndrome (PFS). Our aim was to investigate the effectiveness of inclusion of~     trigger point dry needling into the management of idividuals with patellofemoral pain~     syndrome.~   "
80441|NCT02513992|"~     Ictal SPECT with intravenous injection in a cubital vein of a perfusion tracer is an~     established technique to localize the ictal onset zone during presurgical evaluation of~     refractory focal epilepsy. When seizures last less than 10 seconds, localizing information is~     often not obtained. Since it takes around 30 seconds before the tracer reaches the brain~     after intravenous injection, ictal hyperperfusion most likely has already switched to~     postictal hypoperfusion. In this study, we plan to inject the perfusion tracer in the aorta~     proximal to the cerebral arteries, which will allow a true ictal injection in patients with~     seizures of short duration.~   "
80459|NCT02513758|"~     Genital mucosa is the main way of HIV penetration. Many cells can be involved (epithelial~     cells, Langerhans cells) and antibodies may also play a critical role. The investigators'~     study aims to precise the role of each type of cells, the interaction cell-cell and~     cell-antibodies.~   "
96767|NCT02300571|"~     This observational study is proposed to observe the effect of high-dose, post-transplantation~     cyclophosphamide after a T cell-replete, HLA-matched PBSC graft from an HLA-identical or~     mismatched donor.~   "
80442|NCT02513979|"~     An angiotensin II type 2 receptor (AT2R) antagonist has been assessed for its efficacy in~     neuropathic pain with promising results. A considerable number of patients undergoing surgery~     under general anesthesia are hypertensive and receive drugs to control high blood pressure,~     including angiotensin II receptor antagonists. These drugs may attenuate the acute and/or~     chronic postoperative pain or decrease the analgesic requirements after surgery. The aim of~     the present study is to assess the early postoperative pain and analgesic requirements in~     patients treated with antagonists of the angiotensin II receptors for at least three months~     before surgery compared to normotensive patients.~   "
80443|NCT02513966|"~     There is a decrease in the amount of blood components used during cardiac surgery in the last~     four years. As the hemovigilance team of the investigators' Hospital the investigators want~     to find out the causes and effects of this decrease.~   "
80444|NCT02513953|"~     Objective:To present an extremely rare site of occurrence of endometriotic cyst in the layers~     of Broad Ligament.~      Patient:A 32 yrs.old woman,married 4 yrs.,presented to OB-GY Dept.with acute,gnawing pain in~     lower abdomen and history of sub-fertility.Diagnostic Laparoscopy and pelvic ultrasound were~     performed in emergency.Oblong cyst structure,41x21x23mm in the left adnexa,away from ovary~     and uterus was identified and excised by Four Port laparoscopic interventional surgery.~   "
80445|NCT02513940|"~     Torsades de pointes (TdP) is a potentially fatal ventricular arrhythmia associated with~     corrected QT (QTc) interval prolongation. More than 50 commonly used drugs available on the~     US market may cause QTc interval prolongation and TdP. While TdP occurs more commonly in~     women, 33-45% of all cases of TdP have occurred in men. Older age is a risk factor for~     drug-induced TdP in men, possibly due to declining serum testosterone concentrations.~     Available evidence shows an inverse relationship between QTc intervals and serum testosterone~     concentrations. In addition, experimental data, including those from the investigators'~     laboratory, suggest that both exogenous testosterone or progesterone administration may be~     protective against prolongation of ventricular repolarization and TdP. Specific Aim:~     Establish the influence of transdermal testosterone administration and oral progesterone~     administration as preventive methods by which to diminish the degree of drug-induced QT~     interval prolongation in men 65 years of age or older. Hypothesis: Transdermal testosterone~     administration and oral progesterone administration both effectively attenuate drug-induced~     QT interval response in older men. To test this hypothesis, transdermal testosterone, oral~     progesterone or placebo will be administered in a 3-way crossover study to men 65 years of~     age or older. QTc interval response to low-dose ibutilide will be assessed. The primary~     endpoints will be individually-corrected QT interval (QTcI) response to ibutilide, in the~     presence and absence of testosterone, and in the presence or absence of progesterone: 1)~     Effect on pre-ibutilide QTcI, 2) Effect on maximum post-ibutilide QTcI, 3) Effect on % change~     in post-ibutilide QTcI, and 2) Area under the QTcI interval-time curves.~   "
80446|NCT02513927|"~     Hypertension is one of the most common cardiovascular diseases, which is a major risk factor~     for stroke and cardiovascular events. Traditionally, cardiovascular risk stratification in~     hypertensive patients was based on the average blood pressure (BP) measured in the clinic.~     Accumulated data has shown that target-organ damage is related not only to 24-h mean~     intra-arterial BP, but also to BP variability (BPV) in subjects with essential hypertension.~     Growing evidence demonstrated that BPV has considerable prognostic value for all-cause~     mortality and cardiovascular outcomes, independent of average BP.~      At present, the normal range of BPV is not very clear. There are many studies about the~     effects of different kinds of drugs on blood pressure, but the clinical researches about the~     impacts of antihypertensive drugs on BPV are limited, and the conclusion is still~     controversial.~   "
80447|NCT02513914|"~     Pseudotumor cerebri, also called idiopathic intracranial hypertension (IIH), is characterized~     by elevated intracranial pressure, headache, and if severe, vision loss. IIH is difficult to~     treat. Medical management may not adequately resolve the symptoms, and surgical management~     (primarily through cerebrospinal fluid [CSF] shunting) has a high failure rate. Recently, a~     relationship between IIH and stenosis of the dural venous sinuses (the veins that drain blood~     from the brain) has been reported. In patients with IIH in whom there is stenosis of one or~     more dural venous sinuses, placing a stent in the venous sinus may improve patients'~     objective symptoms (such as visual loss and papilledema) and subjective symptoms (such as~     headache). This study will determine whether dural venous sinus stenting is as effective as~     CSF shunting (considered the standard surgical treatment) in treating IIH patients who have~     moderate vision loss and stenosis of the dural venous sinuses.~   "
80448|NCT02513901|"~     HIV replication can be effectively suppressed and acquired immunodeficiency syndrome(AIDS)~     can be prevented with highly active antiretroviral therapy (HAART). However, HIV-infected~     people must remain on treatment continuously to avoid viral rebound and progression to AIDS.~     HIV persistence is thought to stem primarily from the presence of integrated copies of the~     proviral genome within long-lived cells. Because active viral gene expression causes cell~     death due to viral cytopathic effects and the immune response, long-lived cells likely harbor~     transcriptionally silent, latent provirus. HIV-1 persistence in long-lived cellular~     reservoirs remains a major barrier to a cure. HDACi have the potential to activate (Kick)~     these latently infected cells. This will make the HIV infected cells visible to the immune~     system; the immune response and antiretrovirals(ARVs) will be able to attack and eliminate~     (Kill) the infected cells. The purpose of this study is to evaluate the safety and efficacy~     of multi-dose Chidamide in combination with antiretroviral therapy in HIV-infected adults~     with suppressed viral load.~   "
80470|NCT02513602|"~     The evaluation of the bone, using several techniques and on several aspects will be the~     purpose to study the possible impact of the kidney transplant (and, extensively, the~     pre-transplant dialysis, the organ replacement and the immunosuppressive therapy) could have~     on the bone metabolism and on the density of the bone where the implants are placed. The~     assessment on the bone density only in a retrospectively selected population that underwent~     the same surgical procedure will help the comparison of the data to get a satisfactory~     conclusion. The evaluation of other clinical and instrumental parameters in the test group~     makes the kidney-transplant patients bone quality clear, and will consequently demonstrate if~     implants are a feasible therapy for these patients.~   "
80449|NCT02513888|"~     PREVENT-WIN study has three components.~      The work plan will have the following S&T components. Component 1: Cross-sectional Study~      Cross-sectional study will be of 1.5 years where 400 women from rural will be screened~     randomly for the vitamin D deficiency and its determinants including duration of sun~     exposure.~      Component 2: Prospective Study~      This open-label randomized placebo-controlled trial would be done in 150 pre-diabetic women~     with vitamin D deficiency. The women will be recruited from cross-sectional study, out~     patient department and health camps and they will be followed up for 2 years. The women will~     be randomized into two groups; lifestyle modification counseling along with intervention with~     either vitamin D or placebo. The levels of vitamin D and blood glucose will be assessed~     periodically (every 6 months). In those having recurrent vitamin D deficiency, the course of~     vitamin D will be repeated. At the end of the study, incidence of T2DM in both groups will be~     compared.~      Component 3: Information Education and Communication (IEC) Activities:~      There is a paucity of IEC material on vitamin D deficiency in women residing in rural areas.~     IEC material will be developed and IEC activities through various modes like lectures,~     workshops, group discussions, leaflets/booklets distribution and audio video media shows~     (Hindi and English) will be used for educating health professionals, Medical and paramedical~     workers and various village level health functionaries like, Multi purpose workers, anganwadi~     workers, Accredited Social Health Activist under National Rural Health Mission of Government~     of India (ASHA). Besides this, Self Help Groups (SHGs) and women will be told about the~     benefits of balance diet, dietary intake of calcium, vitamin D, benefits of sun exposure and~     adverse health effects of vitamin D deficiency.~   "
80450|NCT02513875|"~     The work plan will have the following S&T components. Component 1: Cross-sectional Study~      Cross-sectional study will be of 1.5 years where 400 women from rural will be screened~     randomly for the vitamin D deficiency and its determinants including duration of sun~     exposure.~      Component 2: Prospective Study~      This open-label randomized placebo-controlled trial would be done in 150 pre-diabetic women~     with vitamin D deficiency. The women will be recruited from cross-sectional study, out~     patient department and health camps and they will be followed up for 2 years. The women will~     be randomized into two groups; lifestyle modification counseling along with intervention with~     either vitamin D or placebo. The levels of vitamin D and blood glucose will be assessed~     periodically (every 6 months). In those having recurrent vitamin D deficiency, the course of~     vitamin D will be repeated. At the end of the study, incidence of T2DM in both groups will be~     compared.~   "
80451|NCT02513862|"~     The purpose of this study is to determine whether autologous platelet rich plasma (APRP)is~     effective in reducing allogeneic blood transfusions during aortic surgery using deep~     hypothermic circulatory arrest.~   "
80452|NCT02513849|"~     Cancer of the gullet (oesophagus) is a lethal disease in which only 15% of patients survive 5~     years once diagnosed. It is more common in men than women, and men appear to have a worse~     prognosis. One suggestion for this gender difference is the sex hormone oestrogen, which~     exerts its effect via oestrogen receptors. The role of oestrogen in breast cancer is well~     described, and antioestrogen medication such as tamoxifen, which blocks oestrogen receptors~     are in widespread and effective use. The role of oestrogen receptors in oesophageal cancer~     however, is less well defined. Work conducted by the investigators, as well as another~     research group in Australia showed that antioestrogens including tamoxifen, reduce~     oesophageal cancer cell growth in the laboratory. To date, no studies have assessed the~     effect of tamoxifen therapy on oesophageal cancer growth in humans. The investigators propose~     a study to determine the effect of tamoxifen in patients with oesophageal cancer who aren't~     undergoing surgery or chemotherapy. Patients will receive tamoxifen tablets daily for 4 weeks~     after which time a biopsy (sample of cancer tissue) will be taken at gastroscopy (a flexible~     camera that is passed into the mouth through the gullet into the stomach). The biopsy will be~     compared with the biopsy taken at the time of diagnosis to determine if tamoxifen has had any~     effect on cancer cell growth. If this study shows that tamoxifen does slow cancer cell growth~     it could lead to a larger study of patients with oesophageal cancer taking tamoxifen for a~     longer time period to determine if there is any clinical benefit.~   "
80453|NCT02513836|"~     In this vital study, the investigators will develop an innovative Opioid Safety (Op-Safe)~     Program for use in pain clinics. The Op-Safe Program consists of two key components:~     Educating patients with an informative brochure and video developed by the Institute for Safe~     Medication Practices (ISMP) Canada, and a screening algorithm to identify unrecognized sleep~     apnea in patients taking opioids for chronic non-cancer pain.~   "
80454|NCT02513823|"~     This pilot study will examine the effectiveness of vitamin D supplementation on reducing~     blood pressure and improving endothelial function. Premenopausal African American women will~     be recruited. Potential subjects will have systolic and diastolic blood pressure measured~     following the American Heart Association Blood Pressure Guidelines. Any individual with an~     average blood pressure > 140/90 mmHg will be referred to their personal physician for follow~     up. Participants with blood pressure readings <140/90 mmHg will be consented and then~     instructed to record food intake for three days to estimate usual dietary intake at baseline~     and at the 10th week timepoint. At the baseline clinic visit a 10 week supply of vitamin D3~     supplements (2,000 IU/day; Nature Made ®) will be given to participants and log sheets~     provided to record supplement intake. For the baseline and the 10 week visits, participants~     will fast overnight and refrain from consuming any caffeinated products, vitamins, or~     medications that may affect vascular tone, and will refrain from smoking. Three successive~     systolic and diastolic blood pressure measurements and the average of the last two~     measurements will be calculated. Anthropometric and body fat distribution assessments will be~     performed. Height and weight will be measured. Percent body fat will be determined by~     bioelectric impedance (Tanita BF-350) by C Moore. Body mass index (BMI) will be calculated as~     weight in kilograms (kg) divided by height squared (m2). Pulse amplitude tonometry (PAT) will~     be measured with the EndoPAT 2000 (Itamar Medical Ltd) which records digital pulse wave~     amplitude (PWA) using fingertip plethysmography. A reactive hyperemia index (RHI) measures~     nitric-oxide dependent changes in vascular tone. Endothelial dysfunction is classified as a~     RHI < 1.67 with average normal endothelial RHI values ranging between 1.7 and 2.0. Blood will~     be drawn for measurement of serum 25(OH)D concentrations by chemiluminescence immunoassay(~     Abbott Architect). Vitamin D deficiency will be defined as serum 25(OH)D levels less than 20~     ng/mL (50 nmol/L) and vitamin D insufficiency as 21 to 29 ng/mL (50 to 80 nmol/L).~     Descriptive statistics, including means and standard deviations for continuous variables and~     frequencies and percentages for categorical variables, will be calculated for study~     variables. To answer the primary research questions, within subjects repeated measures~     analysis of variance (ANOVA) tests will be conducted to test if any differences in blood~     pressure, serum 25(OH)D concentrations, and RHI are statistically different after 10 weeks of~     supplementation with 2,000 IU/d of vitamin D. Furthermore, exploratory multivariate linear~     regression models will be constructed to determine relationships between vitamin D status and~     vascular function parameters (blood pressure, RHI) before and after adjustment for age and~     BMI.~   "
80455|NCT02513810|"~     DES are preferred over BMS for most patients, however prolonged dual antiplatelet therapy is~     required for patients treated with DES for prevention of late or very late stent thrombosis.~     which increases a risk of major bleeding. BioFreedom is a Biolimus A9-coated stent that~     consists of a stainless steel stent platform with a textured abluminal surface without use of~     any polymer in the coating. Biolimus A9 rapid release and polymer-free property may give~     BioFreedom the advantages of both DES and BMS that may require less duration of DAPT.~     BioMatrix Flex, Biolimus-eluting stent with biodegradable polymer, also demonstrated safety~     and efficacy. We will compare these two difference types of Biolimus A9-eluting stents with~     different duration of DAPT. With proven adequate and safe duration, we will compare between~     one versus more than six months of dual antiplatelet therapy after Biolimus A9-eluting stents~     implantation using different properties of BioFreedom and BioMatrix Flex.~   "
80456|NCT02513797|"~     This study is a prospective, multicenter, randomized (2:1) controlled study to evaluate the~     safety and effectiveness of the LARIAT System to percutaneously isolate and ligate the Left~     Atrial Appendage from the left atrium as an adjunct to planned pulmonary vein isolation (PVI)~     catheter ablation in the treatment of subjects with symptomatic persistent or longstanding~     persistent atrial fibrillation.~      This study will be conducted in two stages:~        -  Limited Early Stage (Stage 1): up to 250 subjects at up to 65 sites. (COMPLETED,~          transitioned to Stage 2)~        -  Pivotal Stage/ Phase III (Stage 2): up to 600 subjects at up to 65 sites. (ENROLLING)~          All subjects from both stages will be included in the primary analysis.~   "
80457|NCT02513784|"~     This is a randomized, open-label pilot study to assess whether treatment with chlorhexidine~     mouthwash can alter the esophageal and gastric cardia microbiome~   "
80458|NCT02513771|"~     The purpose of the study is to evaluate whether sitagliptin (Januvia is the brand name for~     sitagliptin) reduces inflammation and immune activation markers in HIV-infected men and women~     when compared to a placebo (inactive medication like a dummy pill). The study evaluated~     whether taking 100 mg of sitagliptin by mouth daily for 16 weeks is safe and effective for~     HIV-infected persons on antiretroviral therapy (ART) who do not have diabetes. Sitagliptin is~     a medication that is used to treat people with diabetes (high blood sugar) but also may~     reduce inflammation in the body.~   "
80460|NCT02513745|"~     Nowadays cataract patient's expectations are closer to those of refractive surgery patients.~     Patients want to be spectacle independent. However, fifteen to twenty percent of cataract~     surgery patients have from 1.00 to 3.00 diopters (D) of corneal astigmatism which makes~     achieving spectacle independence unlikely in this patients unless the astigmatism is treated~     at the time of cataract surgery. Option to treat this astigmatism include corneal or limbal~     incisions (LRIs), the use of toric intraocular lenses (IOLs) or LASIK. Regardless of the~     treatment of choice to correct the astigmatism at time of cataract extraction, a treatment~     plan has to be calculated preoperatively. This planning include: keratometry measurements and~     the use of a calculator to estimate the treatment and orientation of IOL and/or placement of~     the LRIs.~      New technology has been developed and is widely used. Among this technology, we have the~     VERION Image Guided System. This system encompasses a reference unit that takes a picture of~     the eye with the patient in the sitting position creating image of the patient's eye,~     capturing scleral vessels, limbus and iris features. It measures keratometry as well as the~     corneal diameter (limbus) and pupil size. The information captured is transferred~     automatically to its planner where IOL power calculation and astigmatism correction~     calculation are completed. Additionally, intraoperative wavefront aberrometry has been used~     in the last couple of years with increase success.~   "
80461|NCT02513732|"~     The objective of the study is to evaluate the safety and efficacy of XIENCE Xpedition~     Everolimus-Eluting 2.25mm Stent in real world practice in Japanese hospitals.~   "
80462|NCT02513719|"~     The objective of the study is to evaluate the safety and efficacy of XIENCE PRIME SV in real~     world practice in Japanese hospitals.~   "
80463|NCT02513693|"~     Basic requirement for safe performance of the robotic intra-abdominal surgery is a calm and~     clear surgical field after the introduction of a capnoperitoneum. That can be enabled by a~     neuromuscular blockade. Provision of standard neuromuscular blockade is a compromise between~     optimal surgical conditions (sufficiently deep block) and capability to antagonize the block~     rapidly at the end of the surgery. With rocuronium, it is possible to maintain deep~     neuromuscular blockade safely until the very end of the surgery, and unlike with spontaneous~     recovery or reversal of the block with neostigmine, administration of sugammadex at the end~     of the surgery will enable quick and consistent reversal of the block. Project is focused on~     comparison of the parameters of deep and standard neuromuscular blockade - surgical~     conditions (primary endpoint), quality of recovery and turnover time (secondary endpoints).~   "
80464|NCT02513680|"~     In today's society, the search for keeping up with the appearance with no visible signs of~     aging has become common. Therefore, many therapies to try to mitigate these senility markers~     are present in specialized clinics. Such therapies seek grounding in the theories of how the~     skin and its appendages respond to the aging process, causing this way, they can be created~     ways to slow or minimize wrinkles and other consequences of this natural biological process.~     However, this process can be accelerated by exposure to ultraviolet light such as to toxic~     substances as well as tobacco, among others. The low-power laser and light emitted diode~     (LED) characterized by being non-ablative light source, which means phototherapy which does~     not cause physical damage to the epidermis, as the case of CO2 laser ablative and other~     methods. This study has the purpose of comparing the effects of combined application of low~     level laser with LED and LED action alone in facial rejuvenation. For this, the analysis of~     these effects will be conducted through digital photography, blinded assessment and customer~     satisfaction questionnaire.~   "
80465|NCT02513667|"~     The purpose of this study is to see if Ceritinib can target ALK in non-small cell lung cancer~     and slow down cancer growth and prevent it from spreading.~   "
80466|NCT02513654|"~     This Pharmacokinetic (PK) study is going to provide supplemental PK data for supporting~     bipolar Phase III study for New Drug Application (NDA) filing according to regulatory~     requirement. The primary objective of this study is to evaluate the PK of lamotrigine~     following repeat dosing of lamotrigine dispersible tablet in healthy Chinese subjects. This~     study consisted of Screening Phase (Days-14 to 0), Open-label Phase (Days 1 to 51) and~     follow-up Phase (10-17 days after last dosing). After signing the informed consent and~     confirm the eligibility, subjects will start dosing with lamotrigine 25 mg dispersible tablet~     once daily at Day 1 and remain at this dose level for two weeks (Days 1-14), then will be~     titrated to 50 mg once daily at Day 15 and last for weeks 3-4 (Days 15-28), and then titrated~     to 100 mg once daily at Day 29 during weeks 5-6 (Days 29-42). The total duration of the study~     will be approximately 10 weeks including screening and follow-up phase.~   "
80467|NCT02513641|"~     The purpose of this study is to determine if 2-weeks of nightly exposure (7-12 hours) to~     moderate hypoxia (~2,400 meters or 7,500 feet) improves glucose metabolism in people with~     type 2 diabetes.~   "
80468|NCT02513628|"~     Early prognostication in resuscitated cardiac arrest (CA) patients, within the first day~     after admission in the intensive care unit (ICU), remains difficult. Optic nerve sheath~     diameter (ONSD) measurement could predict increased intracranial pressure. Preliminary works~     showed that ONSD measurement could be used to predict outcome in post-CA patients.~      The aim of this study was to assess the ability of bedside ONSD ultrasonographic measurement~     to predict survival and Cerebral Performance Category (CPC) score at hospital discharge in~     post-cardiac arrest patients treated with therapeutic hypothermia (TH).~   "
80469|NCT02513615|"~     Peritoneal dialysis (PD) is a type of kidney replacement therapy for patients with chronic~     kidney disease where the peritoneal membrane is used to filter the blood. Exposure to PD~     fluid results in scarring of the peritoneal membrane and increased blood vessel growth. This~     condition can progress even when peritoneal dialysis is stopped. Therefore, the investigators~     hypothesize glucose in the dialysis fluid may result in DNA modifications called epigenetic~     changes. These changes modify how genes are expressed and how cells function. The~     investigators want to study these epigenetic changes and the effect on peritoneal membrane~     scarring, blood vessel growth and peritoneal membrane function.~   "
80471|NCT02513589|"~     Evaluating an innovative molecular imaging technique to visualize inflammation of the~     atherosclerotic plaque in patients with a recent ischemic stroke (<15 days) with carotid~     stenosis> 50%, by performing a Positron emission tomography-computed tomography (PET-CT) with~     PBR06 18F, a tracer for Translocator protein (TPSO).~   "
97368|NCT02292745|"~     The purpose of this study is to investigate whether combining FOLFIRINOX chemotherapy and~     stereotactic radiotherapy in patients with locally advanced pancreatic cancer leads to an~     increase in survival.~   "
80472|NCT02513576|"~     Sternal instability caused by mediastinitis is one of the most feared complications for~     cardiac surgery team for generating large commitments and functional damages to patients.~     Biomechanically, the contraction of abdominal muscles such as transverse abdominal, produces~     forces that result in a corset-like action and anterior thoracic cage muscles too may~     assist in stabilizing the sternum. Thus, strengthening the abdominal muscles might contribute~     to the recovery of functional aspects. The aim was to evaluate whether contraction and~     strengthening the abdominal muscles could improve lung function and respiratory muscle~     strength in patients with sternal instability.~   "
80473|NCT02513563|"~     The purpose of this study is to find out what effects (good and bad) AZD1775 used in~     combination with carboplatin and paclitaxel will have on participants and their cancer.~   "
80474|NCT02513550|"~     The main purpose of this study is to evaluate the efficacy of ixekizumab dosing regimens in~     participants with plaque psoriasis.~   "
80475|NCT02513537|"~     The ESA is currently preparing a guideline on the management of postoperative delirium (POD),~     which attempts to reduce the impact of postoperative delirium and provide recommendations for~     prevention, diagnostics and treatment of delirium outside the intensive care unit. The~     guidelines are going to be published during 2015.~      While the guideline provides recommendations for daily practice, assessment of current~     practice and knowledge is of utmost importance, because the implementation and the~     measurement of a change in clinical practice will be dependent on these measurements.~      This Survey has been approved by the Scientific and Research Committees of the European~     Society of Anaesthesiology (ESA), the Media Committee of the ESA, as well as the~     institutional ethical committee of Charité - Universitätsmedizin Berlin.~   "
80476|NCT02513524|"~     High blood pressure is a risk factor for bad clinical events, such as heart failure, stroke,~     kidney failure and death. This risk is much higher in those with 'resistant' hypertension, in~     whom the blood pressure remains high despite more than 3 blood pressure medicines. Current~     estimates of the proportion of individuals with resistant hypertension may be an~     overestimate, since some of them are not actually adherent (i.e. not taking the medicines~     they are prescribed). Methods to detect non-adherence, such as asking the patient, counting~     pills, and getting records from pharmacy are not fool proof. Direct observed therapy (where~     patients are administered medicines under observation by a health care personnel) is quite~     useful to diagnose this, and is the standard of care in the Renal Hypertension Clinic, before~     more tests and interventions (such as CT scans, renal angiogram) are performed.~      In this study, the investigators will measure the proportion of patients with resistant~     hypertension who are non-adherent based on direct observed therapy, and follow them up to~     examine the impact of this diagnosis.~   "
80477|NCT02513511|"~     Awake intubation is a recommended safety procedure in specific cases where the intubation or~     ventilation before general anesthesia is at risk.~      Numerous techniques to allow awake intubation have been described, such as pure awake~     technique, local anesthetics or intravenous sedation for example.~      Hypnosis is used for various operating room techniques and surgeries. The investigators aim~     to analyze the feasibility of awake laryngoscopy and intubations on patients placed under~     hypnosis alone.~   "
80478|NCT02513498|"~     This phase II trial studies how well ixazomib citrate works in treating patients with chronic~     graft-versus-host disease. Chronic graft-versus-host disease is a complication of a donor~     bone marrow or blood cell transplant, usually occurring more than three months after~     transplant, in which donor cells damage the host tissue. Ixazomib citrate may be an effective~     treatment for chronic graft-versus-host disease.~   "
80479|NCT02513485|"~     The purpose of this study is to learn more about the changes that happen in the brain and the~     body when a person is depressed. This study will determine if the level of inflammation in~     the body is related to symptoms of depression, how well the person thinks, and how certain~     brain regions communicate.~   "
80480|NCT02513472|"~     This is an open-label, single-arm, multicenter, Phase 1b/2 study of eribulin mesylate in~     combination with pembrolizumab in participants with metastatic triple-negative breast cancer~     (mTNBC) previously treated with 0 to 2 lines of systemic anticancer therapy (cytotoxic or~     targeted anticancer agents) in the metastatic setting.~   "
80481|NCT02513459|"~     This is an open label, single group, long term safety extension trial to provide a long-term~     treatment option for subjects who responded to treatment with BI 655066/ABBV-066~     (risankizumab) in a preceding trial.~   "
80482|NCT02513446|"~     The primary objective of this trial is to investigate the effect of multiple doses of~     itraconazole on the pharmacokinetics of BI 1026706 given as single dose. The assessment of~     safety and tolerability of BI 1026706 is an additional objective of this trial. Furthermore,~     the pharmacokinetics of the metabolite BI 1072668 will be explored.~   "
80483|NCT02513433|"~     This study compares the clinical efficacy of newer local anaesthetic drugs Levobupivacaine~     and Ropivacaine with Bupivacaine in lumbar epidural anaesthesia for hip surgeries.~   "
80484|NCT02513420|"~     Levator Ani Muscle (LAM) avulsion occurs in 13-36% of women having their first birth. These~     damages by palpation and ultrasound of the pelvic floor can be detected. Avulsion of the LAM~     results in decreased muscle strength of the pelvic floor, enlarge the genital hiatus and~     promotes pelvic organ prolapse. The perineal muscle training is a proposal to combine the~     perineal massage with pelvic floor exercises in order to prepare the LAM in the last weeks~     before delivery, to withstand stretching which will be submitted during childbirth. No~     studies in the world that have explored the effect of the perineal muscle training on the~     avulsion of MEA.~      Objective: To quantify the proportion of primiparous that result with avulsion of LAM after~     their first birth among those performing perineal muscle training from week 33 of gestation~     and those with usual prenatal care.~   "
80485|NCT02513407|"~     This randomized pilot research trial studies how well Eat, Move, Live (EML) works in reducing~     chronic disease risk in medically vulnerable communities. Obesity, unhealthy diet, and~     physical inactivity are linked to increased cancer risk, especially hormone-related cancer~     (example, breast cancer). Improving healthy lifestyle practices, namely increasing physical~     activity and encouraging healthy eating behaviors may reduce the risk of getting cancer and~     chronic disease.~   "
80777|NCT02509611|"~     The study's purpose is to assess the effect of yoga on measures of oxidative stress (i.e.~     reduction-oxidation [redox] status); motor function; and psychosocial well-being, and the~     feasibility and acceptability of implementing a Hatha yoga program in PD subjects.~   "
80486|NCT02513394|"~     This is a prospective, two arm, international, multicenter, randomized, open-label Phase III~     study evaluating the addition of 2 years of palbociclib to standard adjuvant endocrine~     therapy for patients with HR+ / HER2- early breast cancer (EBC).~      The purpose of the PALLAS study is to determine whether the addition of palbociclib to~     adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for HR+/HER2-~     early breast cancer. Assessment of a variety of correlative analysis, including evaluation of~     the effect of palbociclib in genomically defined tumor subgroups, is planned.~   "
80487|NCT02513381|"~     This is a double blind randomised placebo-controlled study involving women with polycystic~     ovary syndrome (PCOS). The patients will be randomised either to Vitamin D 3200 IU or placebo~     for three months. The main hypothesis of this study is Vitamin D improves hormonal,~     metabolic and cardiovascular risk markers in women with PCOS.~   "
80488|NCT02513368|"~     The aim of the present study was to propose the employment of Bio-Oss® and Bio-Gide® at~     implant site in order to evaluate if the increased bucco-lingual bone thickness could enhance~     the stability of peri implant soft tissue, when compared to the grafting technique (~     bilaminar technique), performed in association with implant placement .~   "
80489|NCT02513355|"~     Research purpose:~      Degree of continuous intravenous pumping Endostar (human recombinant endostatin) combination~     chemotherapy regimens including cisplatin two medicine first-line treatment of advanced~     non-small cell lung cancer (with the exception of EGFR/ALK mutations) efficacy and safety.~   "
80490|NCT02513342|"~     Explore the efficacy and safety of the treatment of Endostar continuous intravenous injection~     pump combined DP scheme for first-line advanced lung squamous carcinoma and maintenance~     treatment., and explore the predicted biomarkers.~   "
80491|NCT02513329|"~     Vasomotor symptoms (VMS) affect up to 65% of breast cancer survivors and negatively impact~     their quality of life. The investigators aim to evaluate the benefit of SGB in symptomatic~     women with breast cancer who are on anti-estrogens and are seeking relief from moderate to~     very severe VMS that are adversely affecting health and wellbeing. Women with breast cancer~     on Tamoxifen, aromatase inhibitors (AIs) or Selective Estrogen Receptor Modulators (SERMS)~     with moderate to very severe VMS will be enrolled as participants in this study.~   "
80492|NCT02513316|"~     Study I: CROMIS-2 (AF) Prospective cohort study of patients anticoagulated after~     cardioembolic stroke An observational inception cohort study (n=1425) of patients throughout~     the United Kingdom (UK) - (79 hospitals) started on best practice oral anticoagulant (without~     prior use) for presumed cardioembolic ischaemic stroke due to non-valvular AF with follow up~     for the occurrence of intracerebral haemorrhage (ICH) and ischaemic stroke for an average of~     two years. The main baseline exposures (risk factors of interest) are the presence of~     cerebral microbleeds (CMBs) on magnetic resonance imaging (MRI), and genetic polymorphisms in~     candidate genes with potential functional relevance to ICH risk.~      Study II: CROMIS-2 (ICH) Observational and genetics study of intracerebral haemorrhage The~     investigators will also recruit 600 patients admitted to participating centres with ICH (with~     a target of at least 300 anticoagulant-related ICH cases) and collect DNA to increase the~     power of the genetic studies. The investigators will collect clinical and imaging data from~     these ICH cases to investigate risk factors associated with anticoagulant-related ICH~     compared to non anticoagulant-related ICH.~   "
80493|NCT02513303|"~     The objective of this study is to evaluate efficacy and safety outcomes following use of the~     Sirolimus-eluting Collagen Implant (SeCI) in subjects undergoing surgical creation of an AV~     fistula for vascular access (index procedure). Following successful creation of the AV~     fistula, the cohort randomized to the treatment group will receive the SeCI; the control~     group will not receive an implant. The primary hypothesis is that the proportion of subjects~     that meet requirements for fistula suitability for dialysis six months following the index~     procedure will be higher in the treatment group in comparison to the control group.~   "
80494|NCT02513290|"~     The purpose of this study was to verify whether there were differences in health-related~     quality of life of patients with allergic rhinitis treated with bilastine 20 mg compared to~     those treated with loratadine 10 mg.~   "
80495|NCT02513277|"~     People with learning (intellectual) disabilities have more health problems than the rest of~     the population; they are less likely to access help and have lifestyles that may increase~     their risk of getting diabetes (for example, poor diet and lack of physical activity). People~     with learning disabilities may also be prescribed drugs or have certain medical conditions~     (such as Down's syndrome) which can make their chances of getting diabetes greater.~      Diabetes is a long-term condition, which can cause damage to the eyes, heart, kidneys, nerves~     and feet. Impaired glucose regulation happens when sugar levels in the blood are higher than~     normal but are not high enough to be diagnosed with diabetes. People with impaired glucose~     regulation are more likely to develop diabetes, heart disease and stroke in the future. If~     people with impaired glucose regulation make changes to their lifestyle (diet and exercise)~     they can prevent or delay getting diabetes.~      The aim of this study is to screen people with learning disabilities for diabetes and~     impaired glucose regulation. The investigators also want to find out the best way to give~     people with learning disabilities some education around healthy lifestyles (for example,~     eating and exercise) to help with prevention of diabetes and cardiovascular disease.~     Therefore, the investigators also aim to develop a lifestyle education programme that is~     suitable for use in this population and test whether it is feasible and acceptable.~   "
80496|NCT02513264|"~     There is a need for people to take part in research studies to learn more about diseases and~     how to treat them. The Registry for Asthma Characterization and Recruitment 2 (RACR2) will~     create a database of participants with asthma and nasal allergies, or risk factors for these~     conditions, who are potentially eligible for future Inner City Asthma Consortium (ICAC)~     trials. The registry database will include assessments of various asthma and allergy~     characteristics to achieve a more efficient, selective recruitment of these participants for~     other protocols.~   "
80504|NCT02513160|"~     The primary objective of this study is to evaluate the efficacy of beclomethasone~     dipropionate administered via BAI at a dose strength of 40 or 80 mcg per oral inhalation (320~     or 640 mcg/day, respectively) compared with placebo treatment in patients with persistent~     asthma as assessed by the standardized baseline-adjusted trough morning (pre-dose and~     pre-rescue bronchodilator) forced expiratory volume in 1 second (FEV1) area under the effect~     curve from time 0 to 6 weeks (AUEC[0-6wk]).~   "
80497|NCT02513251|"~     Pain is defined as An unpleasant sensory and emotional experience associated with actual or~     potential tissue damage, or described in terms of such damage. In particular, chronic pain~     has significant impact on health care cost and socio-economic aspects of the society. It is~     clear that the development of effective chronic pain management is paramount in reducing the~     significant socio-economic burden of this common healthcare problem.~      One of the difficulties in measuring outcomes in chronic pain patients is the subjective~     nature of pain. The McGill Pain Questionnaire (MPQ) was developed in 1975 with the aim of~     quantifying the subjective pain experiences of patients. Since then it has become one of the~     major assessment tools in evaluation of chronic pain patients during the course of~     treatments. The Short Form McGill Pain Questionnaire (SF-MPQ) developed in 1987 has further~     refined pain descriptors into sensory and affective domains, and incorporating the Visual~     Analog Scale (VAS) for easier administration in hospitals and clinics. The validity and~     reliability of both the original English and translated versions of MPQ and SF-MPQ have been~     well demonstrated. The latest version of Short Form McGill Pain Questionnaire (SF-MPQ-2)~     included descriptive terms for neuropathic pain which expanded the scope of coverage on~     chronic neuropathic pain patients. It has also been evaluated in cancer pain patients.~     Translated versions of SF-MPQ-2 showed good reliability and validity. Therefore the~     investigators devised this study to (1) translate SF-MPQ-2 into Traditional Chinese-Cantonese~     (C-SF-MPQ-2) suitable for use in Hong Kong patients, (2) examine the validity, reliability~     and psychometric properties of this translated version in Hong Kong patients.~   "
80498|NCT02513238|"~     The current study aims to assess the safety and feasibility of the injection of autologous~     adipost tissue derived MSCs on radiation-induced salivary gland hypofunction and xerostomia~     in head and neck cancer participants. The project can potentially help to develop a~     clinically relevant treatment option for the growing number of patients suffering from~     xerostomia after radiotherapy. The development of new therapies is especially important,~     since only sub-optimal symptomatic treatments are currently available and the symptom of~     xerostomia greatly reduces the quality of life.~   "
80499|NCT02513225|"~     The goal of this research study is to evaluate the impact of a paraprofessional-delivered,~     culturally adapted, evidence-based intervention (EBI) on sexually transmitted disease (STD),~     substance use and poor mental/emotional health among American Indians (AI) through a~     Randomized Controlled Trial (RCT). These intertwining risks have produced marked disparities~     and have unique cultural and social determinants in Native communities. If aims are achieved,~     scientific knowledge and community-based practice will be advanced in areas vital to AI~     communities, and to STD and drug prevention science.~      Prior to this study, the investigators applied findings from research protocol (IRB#00005929)~     and adapted a brief intervention to reduce risk and increase protective behaviors for STDs,~     HIV/AIDS, substance use and poor mental/emotional health, and to promote STD screening. The~     specific aim of the current study is to compare the efficacy of the adapted brief~     intervention vs. a comparison condition on participants' condom use, STD screening and~     treatment-seeking behaviors, substance use and emotional/mental health outcomes at 3 and 6~     months post-intervention.~   "
80500|NCT02513212|"~     This study will determine the effects toothbrush type (power or manual) has on the safety and~     effectiveness of professional dentinal hypersensitivity treatment with a marketed~     oxalate-containing solution.~   "
80501|NCT02513199|"~     The purpose of this study is to develop better ways to treat liver cancer, known as~     hepatocellular carcinoma or HCC, while it is still in the liver. Many treatments exist to~     treat tumors in the liver when they are small but after they grow past a certain size, local~     therapies such as surgery, Trans-Arterial Chemo Embolization (TACE), or Radiofrequency~     Ablation (RFA) are not effective. The purpose of this study to test the combination of two~     known treatments - TACE and Stereotactic Body Radiation Therapy (SBRT) - to be used together~     to treat larger or difficult to access liver tumors. Each treatment has been shown to work~     well but has limitations. The study will combine the treatments in an organized sequence and~     monitor closely how effective this combination controls tumors.~   "
80502|NCT02513186|"~     Primary Objective:~        -  To determine the maximum tolerated dose (MTD) and recommended dose (RD) of isatuximab~          when administered in combination with bortezomib, cyclophosphamide, and dexamethasone~          (VCDI) based on the dose-limiting toxicity(ies) (DLTs) observed in patients with newly~          diagnosed multiple myeloma non-eligible for transplantation.~        -  To evaluate safety and preliminary efficacy (overall response rate and complete response~          rate) of isatuximab in combination with 2 bortezomib-based regimens (VCDI) and~          isatuximab with bortezomib, dexamethasone, and lenalidomide (VRDI).~      Secondary Objectives:~        -  To characterize the overall safety profile of isatuximab in combination with each~          bortezomib-based regimen, including cumulative toxicities.~        -  To characterize the pharmacokinetic (PK) profile of isatuximab and each combination drug~          in each isatuximab/bortezomib-based regimen.~        -  To evaluate the immunogenicity of isatuximab in combination treatments.~        -  To evaluate the preliminary efficacy of both bortezomib-based regimens in terms of~          duration of response and progression-free survival (VRDI cohort only).~        -  To assess the relationship between clinical effects (adverse event [AE] and/or tumor~          response) and CD38 receptor density.~   "
80503|NCT02513173|"~     Segmental stabilization exercise has been shown to be effective in the rehabilitation of low~     back pain (LBP). Due to the isometric nature of segmental stabilization exercise, manual~     therapists use various verbal instructions to elicit lumbar multifidus muscle contraction.~     The purpose of this study was to assess whether or not three verbal instructions would alter~     muscle thickness of the lumbar multifidus differently in asymptomatic individuals and~     patients with LBP.~      Three verbal instructions were selected for this study: (1) swell the muscle underneath the~     transducer, (2) draw your belly button in towards your spinal column, and (3) think about~     tilting your pelvis but without really doing it. Lumbar multifidus muscle thickness was~     determined using parasagittal ultrasound imaging. Measurements of muscle thickness were~     collected at rest and during verbal instructions from 21 asymptomatic adults and 21 patients~     with LBP. Percent changes of muscle thickness during contraction and at rest were compared~     between groups and across verbal instructions.~   "
80505|NCT02513147|"~     The purpose of this study is to assess changes in viral reservoir after changing IP/r to~     dolutegravir in HIV-1 infected patients maintaining undetectable viral load on Antiretroviral~     Therapy (ART).~   "
80506|NCT02513134|"~     Recently a prototype of a combination of an anterior segment OCT (VISANTE; Carl Zeiss Meditec~     AG) and an operating microscope (OPMI 200; Carl Zeiss Meditec AG) was introduced that allows~     measurements of the crystalline lens as well as the lens capsule itself after removing the~     crystalline lens of cataract patients intra-operatively. This device uses OCT technology to~     create high resolution B-scans (=images) of the anterior segment of the eye. The OCT was~     shown to be highly reproducible for ACD measurements pre-operatively 12 and small changes of~     the IOL/crystalline lens can be detected 13.~      In a previous study (EK-10-125-0710) that was recently published in the journal~     Investigative Ophthalmology & Visual Science it was shown that intra-operative measurements~     of the anterior lens capsule improve the refractive outcome theoretically.14 However, in this~     previous study conventional eye models were used for IOL power calculation and only the~     intra-operative measurement replaced pre-operative ACD measurements.~      Aim of this study is to observe, whether the postoperative refractive outcome could be~     improved theoretically by using both pre- and intra-operative measurements for retrospective~     IOL power calculation with new eye models.~   "
80507|NCT02513121|"~     This is an investigator initiated study being conducted in equal numbers at two sites, UC San~     Diego and Emory University. The purpose of this study is to understand the potential of a low~     sugar diet for the treatment of nonalcoholic fatty liver disease (NAFLD) in children. Forty~     boys with NAFLD will be randomly assigned to either an intervention group or a habitual diet~     control group. The intervention will be a low sugar diet for a period of 8 weeks. The effect~     of this dietary change will be assessed using advanced MRI testing to measure liver fat.~   "
80508|NCT02513108|"~     The purpose of this study is to provide information on safety of same day discharge after~     uncomplicated percutaneous intervention (PCI) for stable angina pectoris in Norwegian~     clinical practice. The investigators also think that is in patients interest to stay as short~     time as possible in hospital and this will be measured using standardised quality of life~     questionnaires.~   "
80509|NCT02513095|"~     Study EGL-4104-C-1502 is a phase 2, single-site, open-label, randomized, 2-arm parallel study~     of Ryanodex for the adjuvant treatment of exertional heat stroke (EHS) administered~     intravenously (IV), to current standard of care (SOC). SOC for the treatment of EHS is~     defined as effective body cooling, which should be implemented as quickly as available after~     diagnosis of exertional heat stroke.~   "
80510|NCT02513082|"~     This study aims to compare the effectiveness of adductor canal block and femoral nerve block~     in total knee arthroplasty in general anesthesia. Two block techniques were proved safe and~     effective in pain control after total knee arthroplasty. But some authors insist that~     quadriceps muscle power was decreased by femoral nerve block. The study design is a~     double-blind randomized controlled trial. Fifty patients planed to undergo simultaneously~     bilateral total knee arthroplasty are randomised to receive ultrasound-guided femoral nerve~     block on one leg and adductor canal block on the other, in addition to combined general~     anaesthesia. The primary outcome was comparative postoperative pain in either extremity at~     four, eight, 12, 24, 72 hours and 7days postoperatively. Secondary comparative outcomes~     included motor strength by cybex test.~   "
80511|NCT02513069|"~     The primary goal of the study is to evaluate the effectiveness of a combined tele-health and~     contingency management (CM) intervention that the investigators call mobile CM, or mCM, in~     promoting smoking abstinence in US Veterans. The mCM intervention will combine a mobile~     system to reward non-smoking, smoking cessation counseling, and smoking cessation~     medications. The primary aim is to evaluate how effective this intervention is in promoting~     smoking abstinence compared to telehealth interventions for smoking cessation.~   "
80512|NCT02513056|"~     The overall objective of this protocol is to evaluate the safety and utility of diagnostic~     MRI in Center for Medicare and Medicaid Services (CMS) beneficiaries with pacemakers and~     Implantable Cardioverter Defibrillators (ICD) and clinical need for MRI.~   "
80513|NCT02513043|"~     This pilot study is designed to obtain preliminary data on the safety, acceptability, and~     feasibility of direct-to-consumer telemedicine abortion.~   "
80514|NCT02513030|"~     The SIMPLE study was a large one, and lasted quite a few years due to its design as a~     randomized controlled trial and the follow up needed to reach an endpoint. The investigators~     aim to conduct an observational pilot study looking at frequency of positive findings during~     VF testing . The comparator will be the rate of findings during testing in the Simple trial.~     If the investigators will find an increased rate of findings (significantly higher than in~     the Simple trial ) it may set the stage for a randomized controlled trial of replacements ,~     along the line of the Simple trial , or to a recommendation to continue VF testing in all ICD~     replacements.~   "
80515|NCT02513017|"~     Research has shown that persons who have trouble sleeping and experience stress are at risk~     of developing heart diseases. Two treatments, called stimulus control instructions and sleep~     efficiency treatment, that do not involve sleeping pills, have been found effective in~     managing trouble sleeping. This study will be undertaken to find out if the two treatments~     are effective in improving sleep, and reducing stress and the risk of heart diseases. Persons~     with trouble sleeping may have a preference for either treatment. It is believed that if~     persons get the treatment they prefer, then they will be satisfied with the treatment and~     comply with it, and experience improvement in their sleep. This study will also examine the~     extent to which giving persons the treatment of their choice, as compared to giving persons~     treatment based on chance, will lead to higher satisfaction and compliance with treatment,~     and improved sleep. About 300 persons who experience trouble sleeping will be included in the~     study. They will be requested to complete a questionnaire and a sleep diary before and after~     they receive treatment, as well as 6 month and one year later.~   "
80516|NCT02513004|"~     This study is designed to test the hypothesis that the onset of the antiplatelet effect~     90mg-first-dose of ticagrelor will be more rapid and greater than 300mg-loading-dose of~     clopidogrel evaluated by P2Y12 reaction units measured by Verify NowTM P2Y12 assay at 1 hour~     in patients undergoing one-stop Hybrid coronary revascularization(HCR).~   "
80517|NCT02512991|"~     This study compares patients bound for Percutaneous Coronary Intervention (PCI) who were~     transported by either ground ambulance or emergency medical helicopter. The investigators~     describe long-term follow-up in relation to mortality and labour affiliation.~   "
80532|NCT02512796|"~     Gadolinium contrast agents are frequently administered for MRI imaging. Very little is known~     of its toxicity outside of patients with reduced renal function.~   "
80518|NCT02512978|"~     Based on accumulating evidences showing that hypothyroid status is associated with poor~     prognosis among acute myocardial infarction (AMI) patients, the study is designed to evaluate~     whether replacement treatment with levothyroxine could have beneficial effects on patients~     with AMI and hypothyroidism. This is a multicenter prospective computerized-randomized trial~     stratified by ejection fraction with a 1:1 ratio to levothyroxine group or standard therapy~     group.~   "
80519|NCT02512965|"~     The purpose of this study is to find out if SBRT is better than CRT at controlling pain in~     the spine 3 months after receiving treatment.~   "
80520|NCT02512952|"~     Background: To compare the effectiveness of open flap debridement (OFD) alone and OFD along~     with either Autologous Platelet Rich Fibrin (PRF) or Titanium Platelet Rich Fibrin (TPRF) in~     the treatment of intrabony defects (IBDs).~      Materials and methods: Study was conducted on subjects reporting to the Department of~     Periodontics, The Oxford Dental College and Hospital, Bangalore. 38 subjects with 90~     periodontal IBDs of moderate to severe periodontitis were selected and assigned to OFD alone~     (group I) or OFD with Autologous PRF (group II) or OFD with TPRF (group III). In each~     subject, a minimum number of two sextants were present with probing pocket depths (PPD) ≥5mm~     in at least three teeth.~   "
80521|NCT02512939|"~     This study will assess the next generation of blood tests for latent TB infection, which may~     be able to indicate how treatment is working as well as in diagnosis infection.~   "
80522|NCT02512926|"~     This study evaluates the use of carfilzomib in combination with cyclophosphamide and~     etoposide for children with relapsed/refractory solid tumors or leukemia. The medications~     cyclophosphamide and etoposide are standard drugs often used together for the treatment of~     cancer in children with solid tumors or leukemia.~      Carfilzomib is FDA (Food and Drug Administration) approved in the United States for adults~     with multiple myeloma (a type of cancer). However, this drug is not approved for the disease~     being treated in this study. Since carfilzomib has not yet been used in this setting to treat~     this condition, the investigators must first find the best dose to give. The investigators~     are looking for the highest dose of carfilzomib that can be given safely. Therefore, not all~     children taking part in this study will receive the same dose of the study drug in the first~     part of the trial.~   "
80523|NCT02512913|"~     The purpose of this research is to adapt and implement a pregnancy and postnatal smoking~     cessation intervention for couple that will begin early in pregnancy and have an additional~     postnatal component.~   "
80524|NCT02512900|"~     To evaluate the PK profile of a single-dose of 140 mg subcutaneous (SC) administration of~     MEDI9929 (AMG 157) in adolescent subjects with mild to moderate asthma.~   "
80525|NCT02512887|"~     Hypospadias is one of the most common congenital malformations of the genitalia in boys, and~     is typically managed by surgical intervention. During pediatric urological surgery, caudal~     anesthesia is one of the most common regional anesthetic techniques used. Also known as~     caudal block, it has been shown to be a safe and effective anesthetic technique in children~     with a low incidence of anesthesia-related complications.While the reported incidence of~     complications directly associated with caudal block is low, there is scarce and inconclusive~     evidence on the impact of caudal anesthesia on the incidence of surgical complications. As a~     result, the objective of this superiority, randomized controlled trial is to assess whether~     the use of caudal anesthesia, when compared to dorsal penile block, is associated with a~     higher rate of urethrocutaneous fistulas and glans dehiscence post hypospadias repair.~   "
80526|NCT02512874|"~     Frailty is a state of health with predisposition to adverse events, morbidity and mortality.~     Frailty consists of weakness, slowness, low physical activity, exhaustion, and wasting.~     Frailty is associated with increased hospitalizations and death in lung disease. It is~     unknown if pulmonary rehabilitation will improve frailty markers.~   "
80527|NCT02512861|"~     All pediatric patients who undergo cardiac surgery require analgesic medications for~     postoperative pain control and many require sedation to facilitate comfort with cares.~     Parasternal infiltration of local anesthetic for nerve blocks is a simple option to~     postoperative analgesia. The investigators hypothesize that Bupivacaine, a parasternal nerve~     block administered in pediatric patients undergoing cardiac surgery will reduce the~     requirement of Opioids and other pain medications as well as decrease postoperative pain~     scores. This is a prospective, double-blind, randomized controlled trial. Subjects are~     randomized to receive either 0.25% Bupivacaine or normal saline following their~     cardiothoracic surgery.~   "
80528|NCT02512848|"~     Investigators aim to collect endometrial sampling with Li Brush among target population who~     have risks for endometrial neoplasm, then Fractional curettage should performed with these~     participants, investigators intend to compare the pathological diagnosis results of cytology~     and fractional curettage to evaluate the sensitivity of Li Brush and investigators expect~     that the brush can be used for screening of endometrial cancer in the postmenopausal period~     in the clinic.~   "
80529|NCT02512835|"~     Social determinants of health (e.g. the income, education, and environment of patients) may~     exert greater influence on health outcomes than traditional clinical factors (e.g. lab~     results, diagnoses, and family history). Calls for integrating primary care and public health~     are therefore increasing, but merging these domains of care is logistically difficult.~     Research is lacking on the incremental benefit of adding public health data at the practice~     level-- in improving either health outcomes or care delivery. This proof of concept pilot~     will merge data from electronic health records (EHRs) with community vital signs, a set of~     metrics that describes key community resources that affect health. The investigators will~     identify resource poor communities, or cold spots, based on four variables (education,~     poverty, life expectancy, and access to healthy foods) at the census tract level - referred~     to as a community vital sign. The hypothesis is that patients coming from cold spots are more~     likely to have worse health outcomes and that clinicians will deliver better care if they~     know a patient's community context and his/her specific social needs. This study will involve~     12 primary care practices in Northern Virginia that care for more than 170,000 patients.~     Patient addresses will be geocoded for each practice and determine which patients reside in~     cold spots for each community vital sign. The variation for each community vital sign for~     each practice's patients will be calculated and a bivariate and regression analyses will be~     used to determine whether coming from a cold spot is associated with worse clinical quality~     metrics. 15 clinicians will be alerted when they see a patient from a cold spot, patients~     will complete a social needs survey, and clinicians will prospectively document through~     surveys whether such knowledge affects interpersonal interactions (such as time spent with~     patients and the use of clearer language) or clinical management (such as referrals to care~     coordination or community resources). By pragmatically integrating community vital signs into~     care, this innovative proposal will seek to understand which community data clinicians value,~     how these data might influence care, and how best to incorporate these data into clinical and~     population care.~   "
80530|NCT02512822|"~     To evaluate the efficacy of novel noninvasive RF technology for reduction of submental fat.~   "
80531|NCT02512809|"~     The investigators will quantify inflammatory biomarkers in cerebrospinal fluid (CSF) and~     serum of children with hydrocephalus who are undergoing ventriculoperitoneal shunt placement~     under isoflurane anesthesia.~   "
80533|NCT02512783|"~     This is a double blind, randomized, controlled study. The sedationist performing the sedation~     procedure will inject the appropriate amount of either a 1% Lidocaine solution or a placebo~     before the administration of Propofol. A research staff will observe the patient~     simultaneously with the induction of Propofol to determine the patient's pain level, as~     measured by the Face, Legs, Activity, Cry, Consolability (FLACC) scale. The purpose of this~     study is to determine the efficacy of premedication with 1% Lidocaine in decreasing the~     burning sensation caused by intravenous Propofol.~   "
80534|NCT02512770|"~     The aim of this study compares hemodynamic and respiratory changes and complications in~     children who undergoing endoscopy for esophageal balloon dilatation and endoscopy for only~     control.~   "
80535|NCT02512757|"~     This is a prospective, multi-center study to evaluate the diagnostic performance~     characteristics of the AminoIndex™ technology among patients at high risk for developing lung~     cancer as compared with standard lung cancer screening and diagnostic procedures including~     low-dose CT, high-dose CT, biopsy and histopathology.~   "
80536|NCT02512744|"~     Multicenter randomized trial centered on critically-ill tracheostomized patients, comparing~     two different decannulation protocols:~        1. based on capping trials to decide decannulation,~        2. based on the aspiration frequency to decide decannulation time. High-flow conditioned~          oxygen therapy will be applied to all patients through the tracheal cannula. In patients~          included in the suctioning frequency based protocol along the study period and in~          patients included in the capping trial protocol along periods out of capping trials.~   "
80537|NCT02512731|"~     Delayed graft function (DGF) is defined as requirement for dialysis in the first week~     following kidney transplantation. DGF is a common complication occurring in 39% of the~     deceased donor renal transplants at the investigators' institution with significant cost and~     outcome implications. The 3 major risk factors for DGF are donor graft characteristics,~     recipient factors and perioperative management. The most easily modifiable of these factors~     is perioperative management, in particular intraoperative fluid therapy. The investigators~     propose to compare the amount of fluid administered using the current standard of care with~     the fluid administered when optimizing the cardiac output (CO) using Esophageal Doppler~     Monitoring (EDM) to guide fluid therapy. EDM measures blood flow in the descending aorta,~     optimizing stroke volume (SV) and cardiac output (CO) by indicating when fluid administration~     fails to produce an increase in CO.~   "
80538|NCT02512718|"~     Children undergoing hematopoietic cell transplantation (HCT) for cancer or blood disorders~     frequently develop gastrointestinal, metabolic and infectious complications related to~     preparative high-dose chemotherapy and/or radiation-related toxicity. Parenteral nutrition~     (PN) with lipid emulsion is commonly required while gastrointestinal complications preclude~     adequate oral or enteral intake. PN and lipids may increase the risk of metabolic and~     infectious complications in HCT patients who are inherently immune compromised.~      Supplementation with omega-3 fatty acids has been linked to improvements in outcomes in~     several populations. Provision of fish oil lipid emulsion (FOLE), rich in omega-3 fatty~     acids, to children undergoing HCT is an innovative nutritional strategy that could mitigate~     the metabolic and inflammatory side effects of HCT and its treatment. With its potential to~     safely maintain essential fatty acid status, normalize blood lipids and alleviate the~     inflammatory response to illness, the use of FOLE may reduce the risk of infections,~     regimen-related toxicity, and other morbidities after HCT.~      A randomized, controlled pilot study is proposed to test the safety and tolerability of FOLE,~     compared to standard lipid emulsion, in 20 children during hospitalization for HCT. Results~     of this study will provide the preliminary data needed for a larger clinical trial examining~     the effect of FOLE on important clinical outcomes in this population. This novel approach to~     nutritional care of this high-risk group will advance clinical knowledge of the impact of~     FOLE, and will support further investigation into nutritional adjuncts to pediatric cancer~     treatment.~   "
80539|NCT02512705|"~     The Psychiatric Emergency Services (PES) is an under researched area of clinical practice,~     largely in the management of acutely agitated and violent patients. The goal of this pilot~     randomized clinical trial (RCT) is to assess the benefit of medically monitoring patients~     that present with extreme agitation and/or violent behaviour to PES. Placing them in physical~     restraints and immediately administering chemical restraint, will enable medical monitoring~     of these potentially medically unstable patients. Investigators believe that this practice~     will provide safer management of patients, reduce risk to staff and other patients, reduce~     risk of undiagnosed medical conditions that underly the agitation, and increase clinical~     management and quality of care. Patients that come into the Emergency Department that are~     agitated and violent, where verbal-deescalation will not suffice, will be randomly treated~     with either immediate placement in seclusion (current practice) or be placed in physical~     restraints and given chemical restraint (as outlined in the BETA project guidelines). The~     same time interval assessments will be performed on both groups of patients including;~     medical monitoring and agitation scale assessment. Data will also be collected on number of~     violent episodes, code whites, required increase in the use of physical restraints, length of~     intervention, and more. This assessment will enable a comparison between the current practice~     and the proposed practice to establish evidence based clinical guidelines for the management~     of acute agitation in PES, where de-escalation techniques are ineffective and the lack of~     medical monitoring is harmful to the patient and can negatively effect their outcome. In~     order to best assess the importance of medical monitoring for such patients, a pilot study~     must be performed to assess the feasibility of such a phase III RCT study.~   "
80540|NCT02512692|"~     The purpose of this study is to determine the safety and maximum tolerated dose (MTD) of 90 Y~     TARE (Y90) in combination with gemcitabine and cisplatin in patients with unresectable~     intrahepatic cholangiocarcinoma (ICC).~   "
80553|NCT02512523|"~     This is a randomized, double-blind, active control, parallel group, exploratory phase 4 study~     to compare the effect of teneligliptin versus sitagliptin on glucose variability when added~     on to metformin in patients with inadequately controlled type 2 diabetes mellitus.~   "
80554|NCT02512510|"~     The purpose of this study is to measure the effectiveness and safety of TD 4208, an~     investigational drug being developed to treat people with moderate to very severe COPD,~     compared to placebo, a treatment without activity.~   "
80565|NCT02512367|"~     There are few disease prevention programs or programs to manage somatic disorders in a~     psychiatric context. The aim of this study is to evaluate the impact in the medium term of a~     global program to promote dental health on buccodental hygiene in patients with schizophrenia~     and the ability of these patients to follow the intervention.~      This is an interventional trial, randomized in clusters. The participating establishments~     will be randomized to the intervention group (promotion program) or the control group~     (surveillance).~      For each patient, the study will last 12 months altogether and will include an initial~     evaluation of dental health, a 6-month education program for dental care (for patients in the~     intervention group) and a follow-up at 6 and 12 months after the start of the study. The~     follow-up will evaluate dental health and quality of life.~   "
80541|NCT02512679|"~     Many genetic diseases of lymphohematopoietic cells (such as sickle cell anemia, thalassemia,~     Diamond-Blackfan anemia, Combined Immune Deficiency (CID), Wiskott-Aldrich syndrome, chronic~     granulomatous disease, X-linked lymphoproliferative disease, and metabolic diseases affecting~     hematopoiesis) are sublethal diseases caused by mutations that adversely affect the~     development or function of different types of blood cells. Although pathophysiologically~     diverse, these genetic diseases share a similar clinical course of significant progressive~     morbidity, overall poor quality of life, and ultimate death from complications of the disease~     or its palliative treatment. Supportive care for these diseases includes chronic transfusion,~     iron chelation, and surgery (splenectomy or cholecystectomy) for the hemoglobinopathies;~     prophylactic antibiotics, intravenous immunoglobulin, and immunomodulator therapies for the~     immune deficiencies; and enzyme replacement injections and dietary restriction for some of~     the metabolic diseases. The suboptimal results of such supportive care measures have led to~     efforts to implement more aggressive therapeutic interventions to cure these~     lymphohematopoietic diseases. The most logical strategies for cure of these diseases have~     been either replacement of the patient's own hematopoietic stem cells (HSC) with those~     derived from a normal donor allogeneic bone marrow transplant (BMT) or hematopoietic stem~     cell transplant (HSCT), or to genetically modify the patient's own stem cells to replace the~     defective gene (gene therapy).~   "
80542|NCT02512666|"~     This research study is looking at a small device that measures white blood cell (WBC) counts~     by being placed against the finger nail for participants who are undergoing stem cell~     transplantation at Massachusetts General Hospital or have a hematologic malignancy and are~     being seen as an outpatient.~   "
80543|NCT02512653|"~     Biological Standardization of Cupressus arizonica Allergen Extract.~   "
80544|NCT02512640|"~     Ischemia-reperfusion injury resulted from pneumoperitoneum during laparoscopic surgery have~     been reported in some literatures. There are no studies investigating the time course of~     changes in oxidative stress markers in volume-controlled ventilation (VCV) and~     pressure-controlled ventilation (PCV) modes. The aim of this study is to compare the~     alterations in oxidative stress in two different ventilation strategies during gynecologic~     laparoscopic surgery.~      Methods:~      Fifty-two patients of ASA physical status I or II were randomly assigned to receive either~     VCV or PCV during laparoscopic gynecologic surgery. Blood gas analysis and ventilation~     variables were recorded 1 minute before (T1) and 1 hour after (T2) pneumoperitoneum. Blood~     samples for malondialdehyde (MDA) measurement were collected at seven points: 1 minute before~     (T1) and 1 hour after (T2) pneumoperitoneum; 30 minutes, 60 minutes, 90 minutes, and 120~     minutes after deflation (T3~T6); and 24 hours after deflation (T7).~   "
80545|NCT02512627|"~     This study aims to investigate and compare the intervention effects of combining exercise and~     cognitive training (either sequentially or simultaneously in a dual-task paradigm) in elderly~     with mild cognitive impairment. The investigators hypothesize that (1) both sequential and~     dual-task training can induce greater improvements in the outcome measures than single mode~     of training; (2) the improvement in cognitive functions and other outcomes may differ between~     the groups.~   "
80546|NCT02512614|"~     In March 2012, the investigators initiated a prospective, cluster-randomized, controlled~     field trial in Kisumu County, located in an area in western Kenya which has the highest~     under-five mortality rate in Kenya with 149 childhood deaths per 1,000 live births 9. The~     study was designed to evaluate the effectiveness of an antimicrobial hand towel (hereafter~     referred to as towel) in preventing diarrheal diseases, acute respiratory infections,~     self-reported fever, and skin infections in children <2 years old.~   "
80547|NCT02512601|"~     This study aims to evaluate whether, in a standardised cohort of patients with mild to~     moderate PTS, monitored for a sufficiently long follow-up period, quality of life measured by~     generic instruments and disease-specific instruments evolves favourably in this patient~     profile.~      Study objective: to evaluate the evolution of quality of life in general and in the specific~     context of the disease of patients who have experienced an episode of deep-vein thrombosis~     (DVT), are affected by post-thrombotic syndrome, are subject to compression therapy and~     receive an additional standard venoactive agent (sulodexide 15 mg twice daily during 6~     months).~   "
80548|NCT02512588|"~     This is a randomized, placebo-controlled, double-blind, multiple cohort, fixed-dose multiple~     crossover, dose-finding study of oral BTD-001 in adult patients with IH or Narcolepsy without~     cataplexy (Type 2).~   "
80549|NCT02512575|"~     This is a Phase I, first-in-human (FIH), randomized, single-blind, placebo-controlled, single~     ascending dose sequential group study in healthy male subjects. The objectives are to study~     the safety, tolerability, pharmacokinetics and effects on glucose homeostasis~     (pharmacodynamics) of AZD9567, an oral differentiated non-steroidal selective glucocorticoid~     receptor modulator (SGRM). The study will also assess the safety, tolerability,~     pharmacokinetics (PK) and pharmacodynamics (PD) of prednisolone 60 mg in comparison with high~     doses of AZD9567 and placebo.~   "
80550|NCT02512562|"~     This is an open-label, two-group, fixed-sequence study to evaluate the effect of ACH-3102 and~     Simeprevir on AL-335 pharmacokinetics in healthy volunteers.~   "
80551|NCT02512549|"~     This study is a randomized parallel group controlled trial which aims to study the effects of~     pulmonary rehabilitation intervention on exercise capacity and quality of life in patients~     with severe COPD as compared to standard medical care. The expected duration is one and a~     half years with effect from 1st July, 2015 and will include 80 patients, 40 in each arm.~   "
80552|NCT02512536|"~     Rotator cuff arthropathy is a cause of shoulder arthritis which is a common condition seen~     both in primary and secondary care. It is a painful condition, with significant disability.~     Specialist shoulder replacements have found acceptance within the trust, nationally and~     internationally although there are high complication rates. There is however a significant~     cost difference (fifty fold) between a reverse total shoulder replacement and a botox~     injection, and to date there have been no randomised control trials, or any registered,~     comparing the use of a botox injection for pain relief in cuff arthropathy versus no~     treatment. If there is a significant clinical difference in the pain outcomes between the~     two, this could result in significant savings to the NHS and the taxpayer as a whole. If high~     levels of pain relief could be predictably obtained using Botulinum A toxin injections then~     potentially patients could avoid the need for surgery.~   "
80555|NCT02512497|"~     The goal of this clinical research study is to learn if giving romidepsin before and after a~     stem cell transplant in combination with fludarabine and busulfan can help to control~     leukemia or lymphoma. Researchers also want to learn the highest tolerable dose of romidepsin~     that can be given with this combination.~      The safety of this combination and the safety of giving romidepsin after a stem cell~     transplant will also be studied.~      This is an investigational study. Romidepsin is FDA approved and commercially available for~     the treatment of CTCL in patients who have received at least 1 systemic (affecting the whole~     body) therapy before. Busulfan and fludarabine are FDA approved and commercially available~     for use with a stem cell transplant.~      The use of the combination of romidepsin, busulfan, and fludarabine to treat the type of~     leukemia or lymphoma you have is considered investigational.~      Up to 30 participants will be enrolled in this study. All will take part at MD Anderson.~   "
80556|NCT02512484|"~     Tuberculosis (TB) control remains a public health challenge. Many people in the UK do not~     have a general practitioner (GP) registration and their only interaction with the NHS is via~     Accident and Emergency (A&E) Departments of hospitals. This is often the case for those in~     hard to reach groups, who are also those often at highest risk of TB. This study seeks to~     assess whether A&E Departments are effective sites for the identification and onward~     management of TB, both in its latent and active forms.~   "
80557|NCT02512471|"~     The aim of this study is to determine the minimum effective volume of local anesthetic~     (ropivacaine 0.275% and 0.325%) required to produce an effective double-injection USG-SCB for~     surgical anesthesia in 90% of patients (MEV90) in young group (18-40 years) and in middle~     aged group (40-65 years) of patients scheduled for elective surgery of one upper limb distal~     to the shoulder.~   "
80558|NCT02512458|"~     This is a prospective, open-label, single arm translational study of cabazitaxel in bone~     Castration Resistant metastatic Pancreatic Cancer (mCRPC) patients. Patient will be treated~     with intravenous (iv) cabazitaxel 25mg/m2 every (q) 21days per standard clinical practice for~     up to 10 cycles or until disease progression or unacceptable toxicity or physician's decision~     or patient's consent withdrawal (whichever occurs first).~   "
80559|NCT02512445|"~     The goal of this project is to determine if a 6-session psychotherapy intervention will help~     Veterans feel less deployment-related guilt and less distress related to their guilt. Half of~     the participants will receive the guilt focused intervention and half will receive a~     supportive intervention.~   "
80560|NCT02512432|"~     To join established study put on by Addition Technologies, Inc. in the surgical implantation~     of asymmetrical INTACS segments to treat myopia and astigmatism in patients with keratoconus.~   "
80561|NCT02512419|"~     The aim of this study is to build upon our tailored print intervention by developing new~     text-delivered intervention materials to complement our print-based physical activity (PA)~     intervention. In Phase 1 we will conduct 6 focus groups with Mexican and Mexican American~     (MA) men to determine content, frequency, and types of text messages desired, and to identify~     cultural themes to incorporate into existing and new materials. Themes from the focus groups~     and sample text messages will be presented to a confirmatory focus group panel. Phase 2 will~     be a 6-month pilot randomized controlled trial with Mexican and MA men (N=60) to test the~     text-enhanced, Spanish language, individually tailored PA intervention vs. publicly~     available, Spanish language health education materials, including information on PA, diet,~     and stress management. This will be followed by post-intervention qualitative interviews to~     solicit suggestions for improvements to help further refine the program. The proposed pilot~     will support a future R01 to establish the efficacy of this multi-media, multi-level PA~     intervention for Mexican and MA men.~   "
80562|NCT02512406|"~     The purpose of this study is to learn more about how patients with Tourette Syndrome deal~     with sensory stimuli in their environment such as bright lights, loud noises, physical~     sensations such as shirt tags, etcetera. We will compare responses of patients with Tourette~     Syndrome to those without Tourette Syndrome.~      The study aims to better characterize sensory processing abnormalities by sensory modality:~     The investigators will use a measuring tool based on Dunn's 1997 model of sensory processing,~     the Sensory Profile, which will allow the investigator to characterize both registration and~     response to external stimuli, as well as to delineate which sensory modalities are affected.~     Identifying which sensory modalities are most affected may guide future research into the~     pathophysiology of sensory processing abnormalities in TS.~      The investigators also aim to correlate sensory processing abnormalities with the presence of~     Obsessive Compulsive Disorder (OCD), Attention-deficit/hyperactivity disorder (ADHD) , and~     autism spectrum disorders.~   "
80563|NCT02512393|"~     The purpose of this research is to study the effects of Transcranial Direct Current~     Stimulation (tDCS) on clinical pain, mobility disability, and pain sensitivity to gain a~     better understanding of the factors that cause pain and disability in people with knee~     osteoarthritis (OA). In particular, people from different ethnic and racial groups may~     experience OA pain differently which is why the focus will be on older Asian Americans and~     non-Hispanic whites. It is important to find a reason for such difference so that a better~     treatment can be found for all OA patients. In addition, the research study will examine if~     there is any ethnic differences in pain and mobility disability. The investigator hypothesize~     that Asian Americans will report greater pain and mobility disability than non-Hispanic~     whites, and that active tDCS will result in improvement in pain and disability compared to~     sham tDCS.~   "
80564|NCT02512380|"~     gastric cancer is a highly aggressive malignancy with a poor overall outcome. The purpose of~     this study is to evaluate the 5-year survival of neoadjuvant S1, oxaliplatin, and docetaxel~     (SLOT) versus S1, oxaliplatin(SOX) in patients with locally advanced, resectable~     gastric/esophagogastric junction (EGJ) cancer.~   "
80582|NCT02512146|"~     The study aims to determine the expression of the ionotropic glutamate receptors in colon of~     irritable bowel syndrome (IBS) patients and evaluate the relationship between the ionotropic~     glutamate receptors and IBS symptoms.~   "
80583|NCT02512133|"~     To compare the intraocular pressure (IOP) and number of glaucoma medications lowering of~     microinvasive glaucoma surgery (MIGS) with the implantation of the trabecular device Hydrus~     (Ivantis) as a solo procedure and 360° selective laser trabeculoplasty (SLT) to treat primary~     open angle glaucoma (POAG).~   "
80566|NCT02512354|"~     This research concerns the contribution of a new examination, high-throughput exome~     sequencing, in the diagnosis of the cause of polymalformative fetal syndromes. With currently~     available examinations, the causes of polyformative syndromes, which correspond to the~     association of several congenital malformations with varying degrees of severity in different~     organs, remain unknown in a large number of cases.~      High-throughput exome sequencing (HTES) is a diagnostic tool that allows the simultaneous~     analysis of all of the coding parts of DNA. This examination has already shown its superior~     diagnostic capability in every post-natal diagnostic context, in particulier in infants with~     malformations associated or not with intellectual deficiency. Its contribution has not yet~     been studied in a large number of fetuses with polymalformations. To investigate the~     usefulness of HTES, we propose to carry out the examination in 100 fetuses with~     polymalformations, as well as the usual examinations including chromosomal microarray~     analysis and possibly the study of specific genes that may explain these malformations. A~     blood sample will be taken from both parents to allow interpretation of the results.~   "
80567|NCT02512341|"~     The purpose of this preliminary clinical study is to assess the quality of a computational~     algorithm that automatically classifies murmurs of phonocardiograms (PCGs) as either~     pathologic (AHA class I) or as no- or innocent (AHA class III) in the pediatric population.~      Each patient is auscultated and diagnosed independently by a medical specialist by means of a~     standard mechanical stethoscope. Additionally, for each patient, a PCG is recorded using a~     Littmann 3200 electronic stethoscope and later analyzed using the computational algorithm. An~     echocardiogram is performed as the gold-standard for determining heart pathologies. The~     results of the computer aided auscultation (CAA) are compared to the findings of the medical~     professionals as well as to the echocardiogram findings.~      Hypothesis: The specific CAA algorithms used in this study are able to differentiate~     pathologic (AHA class I) from no- or innocent murmurs (AHA class III) in a pediatric~     population.~   "
80568|NCT02512328|"~     Feasibility of an newly programmed offline application for smartphones (SPA, APP) for~     colonoscopy preparation offering a 5 day guidance prior colonoscopy containing dietary- and~     behavioral recommendation.~   "
80569|NCT02512315|"~     The standard treatment strategy of locally advanced nasopharyngeal carcinoma (NPC) nowadays~     is concurrent chemoradiation (CRT) based on intensity-modulated radiation therapy (IMRT).~     However, distant metastasis remains the major cause of treatment failure, especially in~     patients with T1-4N2-3M0 diseases (N2-3 NPC). The investigators inferred that it was more~     appropriate to consider N2-3 NPC as a systemic disease instead of a local disease. NACT of~     sufficient intensity such as 4 cycles might be effective enough for control of the~     pre-existing micrometastases. Therefore, the objective of this phase 3 multicenter randomized~     controlled trial is to make a comparison between NACT of 4 cycles plus CRT based on IMRT and~     CRT alone in N2-3 NPC on distant metastasis, survival and adverse reaction.~   "
80570|NCT02512302|"~     The purpose of this research study is to determine the amount of medicine absorbed in the~     lungs following dosing via eFlow nebulizer and Seebri® Breezhaler® with and without activated~     charcoal in subjects with moderate to severe chronic obstructive pulmonary disease (COPD).~   "
80571|NCT02512289|"~     tDCS (transcranial direct current stimulation) and robot assisted therapy (RAT) will be used~     in chronic stroke patients to improve a variety of functions with upper limb.~   "
80572|NCT02512276|"~     The purpose of this cluster randomized controlled trial is to evaluate whether a novel~     tele-pharmacist-based intervention for patients with hyperlipidemia, hypertension, and~     diabetes improves medication adherence, disease control, and patients' understanding of their~     treatment.~   "
80573|NCT02512263|"~     The purpose is to assess the adherence and the efficiency of a home-based training program on~     muscular strength, endurance and the quality of life, fatigue, physical activity, anxiety and~     depression for colon cancer patient treated by chemotherapy.~   "
80574|NCT02512250|"~     The Swiss Hemophilia Registry will collect data on the prophylactic and therapeutic use of~     factor concentrates in patients with hemophilia and other severe bleeding disorders in~     Switzerland.~   "
80575|NCT02512237|"~     This is a 2-part, Phase 1 FIH study with Phase 1a designed to determine the maximum tolerated~     dose (MTD)/recommended Phase 2 dose (RP2D) in subjects with metastatic cancers with a human~     epidermal growth factor receptor 2 (HER2) test result that is in situ hybridization (ISH)~     positive (+) or immunohistochemistry (IHC) 3+ or 2+, and Phase 1b designed to assess~     anticancer activity and safety in three expansion cohorts: two different advanced breast~     cancer expansion cohorts (namely, for tumors that test as HER2 ISH positive or IHC3+ and for~     tumors that test as HER2 ISH negative with IHC 2+), and one advanced gastric cancer expansion~     cohort (for tumors that test as HER2 ISH positive or IHC3+).~   "
80576|NCT02512224|"~     Short-term outcomes of parenteral and enteral nutrition for patients unable to eat normally~     were compared and analyzed.~   "
80577|NCT02512211|"~     Spanish Validation of HAL and HEP questionnaire by double translation~     (English-Spanish-English), with a pilotage pediatric patients with hemophilia and adults and~     parents of children with hemophilia. The final validity will be obtained with a sample of~     60-100 patients with hemophilia~   "
80578|NCT02512198|"~     This is a randomised controlled study to evaluate the effect of providing prescribing~     feedback that includes individual patient data to General Practitioners (GP) in Scotland on~     high risk or low quality prescribing.~   "
80579|NCT02512185|"~     This study will examine the impact of modern treatments for metastatic Castrate Resistant~     Prostate Cancer (mCRPC) on several relevant 'geriatric' domains such as daily function,~     objective physical function, and falls. Additionally, the investigators study whether frailty~     is associated with worse outcomes, and whether it is possible to predict the risk of severe~     chemotherapy toxicity in older men.~   "
80580|NCT02512172|"~     This study is being done to test the safety and effectiveness of the combination of~     intravenous (IV) romidepsin and/or oral 5-azacitidine with IV MK-3475 in people with~     microsatellite stable (MSS) advanced colorectal cancer.~   "
80581|NCT02512159|"~     The aim of this study was to evaluate the efficacy of a handicraft topical device of negative~     pressure versus traditional healing treatment for skin ulcers in lower limbs; in patients~     with diabetes mellitus, venous stasis and arterial insufficiency.~   "
80584|NCT02512120|"~     Volume controlled ventilation(VCV) is a most common used ventilation mode during general~     anesthesia. But VCV can cause high airway peak pressure when patient under steep~     Trendelenberg position with pneumoperitoneum. Autoflow-VCV can reduce airway peak pressure~     and improve dynamic compliance. We will compare parameters(arterial blood gas analysis,~     airway compliance, etc) when each group applied VCV and autoflow-VCV during RALP.~   "
80585|NCT02512107|"~     The purpose of this study is to determine if a dried fruit and vegetable supplement (Juice~     Plus+) can alter the gut microbiome and improve gut permeability and inflammatory levels in~     an obese, stressed population.~      The microbiome and its component genes are long known as critical determinants of the~     nutritional value of the food we eat. Recently, it has become clear that the composition of~     this microbiome and its metabolites influences the host immune system, thereby altering host~     physiology. Both obesity and chronic stress have been shown to have an altered gut~     microbiome; both these conditions also lead to increased systemic inflammatory molecules that~     can lead to an increased risk for type 2 diabetes and other diseases caused by chronic~     inflammation.~      Juice Plus+ consumed by an overweight population combined with an eight week exercise regime~     showed decreased markers of protein/lipid oxidation (ox-LDL), total lipid oxidation (TOS) and~     lowered systemic concentrations of the inflammatory cytokine, TNF-α. As systemic cytokines~     are altered by the composition of the gut microbiome, this study proposes to determine if~     this decrease in inflammation by Juice Plus+ is due to a change in the species composition~     and metabolism of the microbiome. This question is particularly relevant for populations with~     high inflammatory loads resulting from excess weight in addition to increased psychological~     stress.~      The investigators propose to determine 1) how Juice Plus+ consumption alters the microbiome~     species composition and metabolism, 2) if there is an alteration in intestinal permeability~     with the consumption of Juice Plus+ and 3) do these alterations coincide with lower systemic~     markers of inflammation and oxidative stress among individuals who are psychologically~     stressed and overweight. The investigators will use a randomized, placebo-controlled design~     with a cohort of overweight, female, critical care health care professionals. Subjects will~     receive the supplements or placebo for sixteen weeks. At the end of 16 weeks, the cohort~     receiving the supplement will be randomized to also receive a meal replacement component or~     follow their normal diet for an additional 4 weeks. Stool and a fasting blood sample will be~     collected at the beginning of the study (baseline) and 8, 16 and 20 weeks later. At each time~     point, subjects will also consume a cocktail of glucose, mannitol and lactulose and a second~     blood draw performed to look at absorption of these molecules.~   "
80586|NCT02512094|"~     Since an increasing in population age, there was an increasing in geriatric patients. Most of~     elderly patients needed rehabilitation programs to regain their quality of life during their~     medical treatments. Barthel index is a functional measurement to evaluate rehabilitation~     improvement in chronically-ill patients and also used for evaluation of patient's self-care.~      Barthel index had been translated into many languages and validated in many medical~     conditions such as spinal cord injury, congestive heart failure, pneumonia, etc. However,~     Barthel index had not been translated into Thai language and validated to use in hip fracture~     patients.~      The purposes of this study were to translate the Barthel index into Thai language and to~     assess validity and reliability of Thai version Barthel index in hip fracture patients.~   "
80587|NCT02512081|"~     This will be an exploratory study, using semi-structured interviews to explore patients'~     experiences of undergoing investigations for Sciatica (leg pain referred from the lower~     back). Interviews will be analysed based on an Interpretative Phenomenological Approach~     (IPA).The end product of analysis will be a detailed account of patients' experiences~     supported by direct quotes.The intention is that this account will help health-care providers~     to understand patients' experiences and to plan and provide Sciatica care that is effective,~     evidence based and acceptable to patients.~   "
80588|NCT02512068|"~     The purpose of this study is to evaluate the efficacy and safety of SYR-472 when administered~     at a dose of 25 mg once weekly using placebo as a control in patients with type 2 diabetes~     mellitus complicated by severe renal impairment or end-stage renal failure and inadequate~     glycemic control despite diet and/or exercise therapy (if given) or despite treatment with~     one other antidiabetic drug in addition to diet and/or exercise therapy (if given); and to~     evaluate the long-term efficacy and safety of SYR-472 when administered at a dose of 25 mg~     once weekly to patients with type 2 diabetes mellitus complicated by severe renal impairment~     or end-stage renal failure.~   "
80589|NCT02512055|"~     Ketamine provides a safety zone for sedated but spontaneously ventilated children especially~     in remote conditions such as radiotherapy units where sedation is an essential practice for~     children to keep calm and motionless In this study, investigators planned to analyse ketamine~     doses needed and the recovery times in pediatric oncology patients undergoing repeated~     radiotherapy sessions.~   "
80590|NCT02512042|"~     This is a randomized, double blind, two-arm, parallel group, active controlled bioequivalence~     study, at multiple clinical trial sites designed to demonstrate bioequivalence of~     Brinzolamide 1% ophthalmic suspension (manufactured by Indoco Remedies Ltd. for Watson Pharma~     Pvt Ltd.), to Brinzolamide (Azopt®) 1% ophthalmic suspension of Alcon Laboratories, Inc. in~     the treatment of chronic open angle glaucoma or ocular hypertension in both eyes.~   "
80591|NCT02512029|"~     This study will evaluate imaging characteristics of 18F-AV-1451 in subjects with subacute~     traumatic brain injury.~   "
80592|NCT02512016|"~     The Motherhood and Pelvic health study (MAP), Bridging physical and cultural determinants of~     postpartum pelvic floor support and symptoms following vaginal delivery, uses mixed methods~     research to study the influences of intra-abdominal pressure, physical activity and strength~     on pelvic floor support and symptoms and the cultural context in which women experience those~     changes.~   "
80593|NCT02512003|"~     The FANTOM I pilot study is intended to assess safety of the Fantom Bioresorbable Coronary~     Scaffold in native coronary arteries.~   "
80594|NCT02511990|"~     This is a phase 1 clinical trial to evaluate the safety, pharmacokinetics and the~     antiretroviral effects of the highly neutralizing anti-HIV-1 monoclonal antibody 10-1074 in~     HIV-infected and HIV-uninfected individuals.~   "
80595|NCT02511977|"~     The control of biofilm around implants is critical to the success of the implant~     rehabilitation of edentulous jaw with overdentures, and it is the dentist's duty to inform~     and guide patients, and keep their maintenance in order to prevent pathological processes~     that can lead to the implanted component loss.The aim of the present retrospective~     longitudinal study was to evaluate through clinical periodontal parameters and radiographic~     images in dental implants rehabilitated with overdentures installed seven years ago.~     individuals who underwent the installation of dental implants for making full~     implant-supported upper and lower mucus dentures in the Department of Implant Dentistry,~     Faculty of Dentistry, University of Santo Amaro, São Paulo, Brazil, in 2007. The periodontal~     parameters such as probing depth, plaque index, bleeding index and mobility as well as~     radiographic examination, are key to determine the correct diagnosis in dental implants. The~     control of biofilm around the implants seems to be a decisive factor for maintaining tissue~     health. We believe that the maintenance appointments are fundamental, but more studies should~     be conducted to elucidate microbial and immunological factors in implants placed and due for~     some time.~   "
80596|NCT02511964|"~     The objective was to determine the effect of six running sessions of high intensity interval~     training (HIIT) at 1% and 10% incline on VO2max, peak of velocity (VPeak), and time limit of~     1% (TLim1%) and 10% (TLim10%) of inclination, as well as the influence of the specificity of~     training on performance in the different inclines.~   "
80597|NCT02511951|"~     The aim of this study is to investigate a new pancreaticojejunal (PJ) anastomosis procedure~     named One-layer duct-to-mucosa pancreaticojejunostomy in pancreatoduodenectomy, which could~     provide a feasible option to pancreatic surgeons for patients with pancreaticoduodenectomy.~   "
80598|NCT02511938|"~     This study will introduce healthy child menu items into 8 independent full service~     restaurants in San Diego County. The restaurants will be assigned either to receive new,~     healthy kids' menu items or to receive the new menu items in addition to marketing materials~     and staff trainings to support promotion of these new menu items. The primary outcome for the~     study is sales of kids' menu items. Additional customer observation and interview data will~     be collected, as well as manager interviews and restaurant environment assessments. Process~     evaluation measures will also evaluate the implementation of the intervention.~   "
80599|NCT02511925|"~     If patients acquire a new infection whilst in hospital this can cause significant morbidity,~     prolonged hospitalisation and even death. Indeed, there is much public concern about~     infections such as MRSA. Patients who require intensive care are probably at the greatest~     risk.~      Appropriate hand hygiene by healthcare workers can reduce infection rates and is a key goal~     of many patient safety initiatives. Worldwide, hand hygiene compliance has been estimated at~     only 38.7% despite the intervention being simple and cheap. Reasons for poor compliance~     include lack of time, skin irritation, lack of facilities, intensity of workload and~     forgetfulness. Furthermore, since cross infection may not be apparent for some days, staff~     may not associate their (lack of) actions with having caused harm.~      Measuring compliance levels enables staff to understand whether they could improve. Direct~     observation of staff is labour intensive and is not continuous or universal. We will monitor~     hand hygiene compliance with a newly developed electronic system (MedSense, General Sensing~     Inc.). We will use the data to provide feedback to the staff in several ways. We hypothesise~     that comprehensive personalised feedback will reduce healthcare associated infections. We~     will undertake the study in three intensive care units.~   "
80600|NCT02511912|"~     The objective of this study, is to assess the safety and performance of the V-Wave System~     when implanted in patients with severe chronic heart failure.~   "
80601|NCT02511899|"~     Investigation of the acute effects of a single dose of Careless™, a Mangifera indica fruit~     powder on cutaneous microcirculation and endothelial function.~   "
80602|NCT02511886|"~     This study will determine the maximum tolerated dose (MTD) of arbaclofen placarbil (AP) in~     the treatment of subjects with Alcohol Use Disorder (AUD). For every two subjects receiving~     AP, one subject will receive placebo.~   "
80603|NCT02511873|"~     This is a Phase II, 2 arm randomized crossover study. Subjects will be assigned to either~     active agent or placebo and then crossover to the other arm. This study is designed to~     evaluate whether Fycompa improves the quality of life in patients with small fiber~     neuropathy.~   "
80604|NCT02511860|"~     This is a study of women aged 18-65, to determine the physiological effects of consuming~     burdock root in supplement form. Burdock has long been used by herbalists for its diuretic~     and blood sugar lowering properties.~   "
80605|NCT02511847|"~     [Background]: Triple-negative breast cancer (TNBC) is defined by a lack of expression of both~     estrogen and progesterone receptor as well as human epidermal growth factor receptor 2~     (HER-2). TNBC is characterized by distinct molecular, histological and unfavorable clinical~     features despite the high rates of response to chemotherapy. Based on the above reasons, it~     is important to emergently develop novel therapies and/or treatment strategies to increase~     treatment efficacies and the survival rate of TNBC.~      [Rationale]: Overexpression of epidermal growth factor receptor (EGFR/ErbB1) and EGFR~     mutation have been reported in TNBC and may therefore be a valid target for anti-tumor~     therapy in TNBC. Afatinib (BIBW 2992) is an ErbB-family blocker that irreversibly inhibits~     signaling from all relevant ErbB-family dimers. Afatinib has demonstrated preclinical~     activity in triple-negative breast cancer cell lines and xenograft models of breast cancer,~     and clinical activity in phase I studies. Based on the assumption that uncontrolled~     ErbB-signaling is directly related to an increased oncogenic potential in TNBC, the studying~     afatinib in the neoadjuvant treatment of TNBC patients is important and provides a novel~     therapy.~      [Aims] The primary endpoint is to evaluate the pathologic complete response of the~     combination of afatinib and weekly paclitaxel in TNBC patients receiving neoadjuvant~     treatment. The secondary endpoints are to evaluate the clinical response and safety of~     afatinib with and without paclitaxel, and to explore the different afatinib-affecting~     downstream molecular pathways as well as potential biomarkers predicting the response of~     afatinib with and without paclitaxel.~      [Patients and methods]: Patients with TNBC (clinical T2-T3, N0-N1, M0; clinical T1-3, N1-2,~     M0; or any T4a tumor) and received neoadjuvant treatment will included in this open, label,~     multi-center phase II study. Our schema is as follows: (1) Afatinib 40 mg per day for 14~     days, then evaluation, every subject will go into the following phase no matter whether she~     had response or not (2) the following phase (the combination with afatinib and paclitaxel):~     Afatinib 40 mg per day, day 1 to day 21, in combination with paclitaxel 80 mg/m² on days 1,~     8, 15 in a 3-weekly course. In addition to the clinical assessment, we will evaluate the~     potential predictive biological markers of activity of Afatinib with and without paclitaxel~     and dynamic changes of molecular makers ([serum and tissue samples: before treatment, 2 weeks~     after treatment, and operation timing]; potential molecules, such as EGFR, EGFR-signaling,~     FGFR, FGFR-signaling, ERK, p53, NF-κB, and etc. were evaluated through the~     immunohistochemical stains, mutation analysis, mRNA [RT-PCR], single nucleotide polymorphism~     analysis, and FISH analysis). In addition, the genetic expression profiles will be compared~     between afatinib-responsive and afatinib-unresponsive samples.~      [Expected Results]: The promising clinical activity, tolerable toxicity, and potential~     biomarkers of afatinib with and without paclitaxel in TNBC patients receiving neoadjuvant~     setting will be demonstrated. The results from this study can be used to conduct a larger~     trial that would allow us to confirm or validate the hypotheses generated.~   "
80606|NCT02511834|"~     Post marketing surveillance (PMS) study. 200 patients will be enrolled in a prospective,~     multi center, randomized, two-arm, open label, and controlled, enrolling patients with multi~     vessel atherosclerotic coronary artery disease, scheduled to undergo Coronary artery bypass~     grafting (CABG) with arterial grafting of IMA to LAD, one saphenous vein graft (SVG) to the~     right territory and one or more SVGs to the left territory. Of all vein grafts, one will be~     selected randomly to receive treatment with VEST and another designated Control.~   "
80607|NCT02511821|"~     This pilot clinical trial studies an electronic monitoring device of patient-reported~     outcomes (PROs) and function in improving patient-centered care in patients with~     gastrointestinal cancer undergoing surgery. Electronic monitoring is a technology-based way~     of asking patients about the quality of life, symptoms, and activity using online surveys and~     an activity tracking watch may make it easier for patients to tell their doctors and nurses~     about any issues before and after surgery. Electronic systems of assessing PROs may increase~     the depth and accuracy of available clinical data, save administrative time, prompt early~     intervention that improves the patient experience, foster patient-provider communication,~     improve patient safety, and enhance the consistency of data collection across multiple sites.~   "
80608|NCT02511808|"~     The purpose of this study is to understand how certain interventions help people reduce or~     quit their drinking and how certain interventions may help best at certain points in time in~     the change process.~   "
80609|NCT02511795|"~     The purpose of this Phase 1b, multi-centre, dose escalation study is to find the maximum~     tolerated dose (MTD) of AZD1775 combined with olaparib in patients with refractory solid~     tumours~   "
80610|NCT02511782|"~     The aim of this study is to measure local inflammatory responses in patients undergoing an~     allogeneic stem cell transplant and attempt to define any set of biomarkers that are~     significantly altered in acute or chronic skin graft versus host disease.~   "
80627|NCT02511561|"~     This is a 1-month, multicenter, open-label study in subjects with unilateral otitis externa.~     Eligible subjects will receive a single dose of 6 mg OTO-201 to the affected ear. The study~     is designed to characterize safety, procedural factors and clinical effect of OTO-201~     administered in subjects with otitis externa.~   "
80628|NCT02511548|"~     The main objective of this study is to reach 80% circumcised men in a random sample of men~     living in the township of Orange Farm (South Africa).~   "
80629|NCT02511535|"~     Allergic patients especially those undergoing de-sensitization treatment have an altered~     immune responsiveness. The investigators aim to find out whether this influences immune~     responses to primary and booster vaccinations.~   "
80630|NCT02511522|"~     The purpose of this study is to see whether one dose of palliative radiation therapy directed~     to the liver in combination with standard BSC might help to reduce liver pain/discomfort due~     to cancer when compared to getting standard BSC alone.~   "
80611|NCT02511769|"~     The proposed study will determine whether the efficacy of WebMAP cognitive behavioral therapy~     (CBT) treatment study generalizes to pediatric sickle cell disease (SCD), and explore whether~     the intervention is feasible and acceptable to this population. Feasibility of~     multi-institutional recruitment from sickle cell centers will also be determined. The~     short-term goal is to produce preliminary data to apply for an R01 proposal to carry out a~     multi-institutional randomized controlled trial (RCT) of internet-delivered behavioral~     intervention in a large population of youth with SCD. The long-term goal of this research is~     to develop effective, easily accessible, behavioral pain interventions for youth with SCD to~     reduce the long-term impact of pain on function, quality of life, and health service use in~     this population.~      The design of this study is an experimental 2 (group) x 3 (time of measurement) randomized~     controlled trial design to test the acceptability and efficacy of the Web-MAP intervention in~     reducing pain and functional impairment in youth with sickle cell disease. (Figure 1)~     Subjects will be randomized to either the behavioral intervention or the online patient~     education control group. The treatment protocol will be implemented over 8 weeks in~     Internet-based treatment modules. The primary study outcome is pain and functional impairment~     measured at baseline, immediately post-treatment, and at 3-month follow-up.~   "
80612|NCT02511756|"~     The primary objective of this study is to investigate the anti-angiogenic effect of~     bevacizumab measured by CTP as a predictive marker for efficacy measured by progression-free~     survival (PFS) in mCRC patients under first-line bevacizumab-containing,~     fluoropyrimidine-based chemotherapy~   "
80613|NCT02511743|"~     The aim of this study was to evaluate knowledge and behavior of physicians regarding~     Hepatitis B Virus. The investigators designed a 30-item self-administered questionnaire~     assessing physicians' knowledge and behavior regarding chronic Hepatitis B Virus infection.~     These results provide data support for updating guidelines, continuing training, and even~     developing policies in medical insurance.~   "
80614|NCT02511730|"~     The purpose of this pilot is to provide credible performance estimate information in order to~     conduct subsequent reader studies.~   "
80615|NCT02511717|"~     Overactive bladder causes urinary frequency, urgency and in some cases urgency incontinence.~     This study is testing the efficacy of transcutaneous tibial nerve stimulation (using skin~     patch electrodes via a transcutaneous electrical nerve stimulation (TENS) machine) for the~     treatment of women with clinical symptoms of overactive bladder.~   "
80616|NCT02511704|"~     The purposes of this study are 1) to determine the pharmacokinetics of nicotine after~     multiple dose administration by electronic cigarette and 2) to compare the acute effects of~     multiple dose of nicotine administrated by electronic cigarette compared with those obteined~     by cigarette.~   "
80617|NCT02511691|"~     Based on PET (18-PSS232) and MRI, glutamate release after N-acetylcystein challenge will be~     monitored in human brains.~   "
80618|NCT02511678|"~     This study will evaluate the efficacy of cryoablation for palliation of painful metastases in~     patients with metastatic lesions involving bone who have failed, are not candidates for, or~     are not experiencing adequate pain relief from current pain therapies (e.g. radiation,~     analgesics).~   "
80619|NCT02511665|"~     This is a randomized, placebo-controlled, double-blind, window of opportunity study~     investigating the biological mechanism of metformin in prostate cancer.~   "
80620|NCT02511652|"~     The aim of the study is to compare the performance of two supraglottic airway devices (SGA),~     the new Ambu AuraGain and the LMA Supreme, in sixty female patients undergoing gynaecologic~     laparoscopy in the trendelemburg position.~      Primary outcome is the airway seal pressure. Secondary outcomes are ease of insertion,~     quality of ventilation, endoscopic view of the glottis, gastric tube passage and~     complications.~   "
80621|NCT02511639|"~     The purpose of this study is to compare maintenance Aromatase Inhibitors (AIs) + everolimus~     with Aromatase Inhibitors alone after 1st line chemotherapy in patients with HR+ metastatic~     breast cancer.~   "
80622|NCT02511626|"~     Endometriosis, one of the most common diseases of women during their reproductive period.,~     may present a chronic disabling disease with major impact on women's life. Therapeutic~     options are limited and recurrence of disease symptoms is frequent.~      The current study investigates the quality of life and several risk factors for the~     development of endometriosis as well as satisfaction with medical support in a minimum of 600~     women with different stages of endometriosis and the same number of control women matched for~     age (± 3 years) and nationality. To evaluate specific features of endometriosis-associated~     pain a second group of 100 women with chronic abdominal/pelvic pain not related to~     endometriosis is investigated. Recruitment takes place in different university clinics, and~     districts hospitals in Switzerland, Germany. And Austria. Control women i.e. women without~     any evidence for endometriosis presenting for annual routine gynaecological controls are~     collected at the same places.~      A composition of different internationally validated questionnaires as well as specific~     questions on dealing with endometriosis is used to collect information on the quality of life~     and potential risk factors for endometriosis. Questions on sexuality and partnership are also~     distributed to women's partners. All diagnosis of endometriosis and classification of ASRM~     (American Society for Reproductive Medicine) disease stages are based on woman's medical~     charts.~   "
80623|NCT02511613|"~     The purpose of this study is to evaluate anatomical and functional effect of combination~     therapy of Squalamine Lactate Ophthalmic Solution, 0.2% administered twice daily with monthly~     ranibizumab intravitreal injections in patients with choroidal neovascularization due to AMD.~   "
80624|NCT02511600|"~     The goal of this clinical research study is to compare Progel® (a type of surgical sealant~     that is made from human blood products) to the standard of care (talcum powder) to learn if~     one method is better than the other for preventing air leaks in patients having a pleurectomy~     decortication.~   "
80625|NCT02511587|"~     FSME-Immun® is registered for application into the muscle. This study investigates if~     application under the skin leads to a comparable immune response.~   "
80626|NCT02511574|"~     The aim of this study is to compare the effectiveness between the cervical pessary and the~     natural progesterone in reduction of preterm birth rates in pregnant women with a uterine~     cervical length of 25 mm or less evaluated by transvaginal ultrasonography.~   "
80631|NCT02511509|"~     Electroconvulsive therapy has been used in clinical practice since 1938, a number of~     randomized trials found significant differences favoring ECT in response rates between~     individuals with depression receiving real and sham ECT. Results of early studies performed~     on patients with schizophrenia weren't so clear, only few of these trials found appreciable~     differences between real and sham ECT in clinical outcome. The recent, more reliable studies~     have found that ECT is efficacious on different symptoms which might be present in the course~     of schizophrenia, for example, psychotic and affective ones, as well as suicidality. The~     serious complications of electroconvulsive therapy are rare, however, more frequent side~     effects may include cognitive impairment and postictal delirium. Thus, the researchers try to~     develop new, more effective and less harmful procedures of ECT, like bifrontal electrodes.~     The available studies revealed that bifrontal ECT has equal efficacy to bitemporal ECT with~     less cognitive impairment, but the literature examining this placement is limited to major~     depressive disorder and the results are inconsistent. In the worldwide literature there is~     lack of studies regarding the use of bifrontal ECT among patients with schizophrenia. It is~     interesting how bifrontal ECT would affect axial symptoms of schizophrenia, since the~     electrodes in this procedure are placed over the brain areas responsible for negative~     symptoms. This randomized, double blind study is going to assess whether the bifrontal ECT is~     more effective in the treatment of positive and negative symptoms of schizophrenia, has less~     harmful impact on the cognitive functions and decrease the frequency and severity of~     postictal delirium comparing to the bitemporal ECT. Moreover, as the first worldwide will~     assess the brain dopaminergic activity with the use of PET in the patients with schizophrenia~     after ECT and the impact of the ECT on the concentration of such neurotrophins as~     brain-derived neurotrophic factor-BDNF, neuron specific enolase-NSE and protein S100B.~   "
80632|NCT02511496|"~     This study evaluates the current situation and follow-up of chronic hepatitis C virus (HCV)~     infection in patients co-infected with human immunodeficiency virus (HIV) in Andalusia.~   "
80633|NCT02511483|"~     This study is a randomized, double-blind, placebo controlled clinical trial. The main purpose~     of this study is to determine if postsurgical pain ratings are improved with treatment with~     oral Propranolol, and if the effectiveness of treatment can be modified by the presence or~     absence of SNPs (Single Nucleotide Polymorphism) associated with Cathecol-O-MethylTransferase~     (COMT) and mu-opioid receptor (MOR1) activity. The treatment period will last for three days~     and the observation period will last for six months. Effectiveness of treatment will be~     assessed by means of morphine consumption through quantitative evaluation of IV-PCA (Patient~     Controlled Analgesia) morphine as primary outcome measure.~   "
80634|NCT02511470|"~     The purpose of this study is to determine if the use of a metronome improves chest~     compression rate and depth during cardiopulmonary resuscitation (CPR) on a pediatric manikin.~   "
80635|NCT02511457|"~     Measurement of the cardiac output is one of the important hemodynamic monitoring tools in~     cardiac surgery. It helps determine the type of medications needed to maintain optimal~     hemodynamic status in the entire perioperative period. Thermodilution method using pulmonary~     artery catheter is considered has the gold standard for the measurement of cardiac output.~     Investigators would like to compare the most popular minimally-invasive devices used to~     measure cardiac output using arterial waveform: LiDCO Rapid and TEE with the thermodilution~     method at various phases of the cardiac surgery.~   "
80636|NCT02511444|"~     The purpose of this study is to evaluate the test characteristics of a rapid intrapartum~     real- time polymerase chain reaction (RT-PCR) compared to the intrapartum GBS culture as the~     standard in preterm patients presenting with threatened preterm labor or with obstetric~     indications for preterm delivery.~   "
80637|NCT02511431|"~     Background:~      - Chronic hepatitis D is a liver disease caused by the hepatitis D virus. It can be severe~     and progressive. Most people with hepatitis D will develop scarring and damage to the liver.~     There is no FDA approved drug to treat chronic hepatitis D. Researchers want to know if the~     drugs lonafarnib and ritonavir can help people with chronic hepatitis D.~      Objective:~      - To find out if treatment of hepatitis D with lonafarnib and ritonavir is safe and~     effective.~      Eligibility:~      - People 18 years of age and older with chronic hepatitis D. They must not have HIV or other~     major illnesses.~      Design:~        -  Participants will be screened with medical history, physical exams, and blood tests.~        -  Participants will have 24 weeks of treatment. They will then have 24 weeks of follow-up.~        -  Participants will be in 1 of 6 treatment groups. Those in each group will receive~          different doses of the study drugs. Some groups will start with placebo but will receive~          treatment after 3 months of placebo.~        -  Participants will also take drugs to treat hepatitis B.~        -  Participants will have many visits. These will include:~        -  One three-day stay at the Clinical Center~        -  Physical exams~        -  EKG: small sticky patches will be put on the chest, arms, and legs to trace heart rhythm~        -  Ultrasounds of the abdomen~        -  Urine and blood tests~        -  Stool samples~        -  Eye exams~        -  Evaluations by a reproductive endocrinologist (women) or urologist (men). Men may~          provide a sperm sample (optional).~   "
80638|NCT02511418|"~     This study was done to determine whether Simvastatin (a medication commonly used to treat~     patients with high cholesterol levels in the blood increases blood flow to the kidneys and~     improves renal function in normal volunteers and patients with impaired renal function~     secondary to polycystic kidney diseases.~   "
80639|NCT02511405|"~     The purpose of this pivotal, phase 3, randomized, multicenter study is to compare VB-111 plus~     bevacizumab to bevacizumab in adult patients with recurrent Glioblastoma.~   "
80640|NCT02511392|"~     Objectives.-Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive stimulation~     methods that became widely used as therapeutic tools in neuropsychiatric research. The aim of~     this study is to Evaluate the therapeutic impact of different frequencies of repetitive~     transcranial stimulation (1HZ, 10HZ) in OCD patients. Material and Methods; Forty five~     patients of OCD were participated in the study. All patients fulfilled the diagnostic~     criteria of DSM-IV-TR. The mean age of the patients was 27.1+4.5 years. Each patient was~     subjected to the following: Yale-Brown obsessive compulsive scale (Y-BOCS), Hamilton Anxiety~     Rating Scale (HAM-A), and Clinical Global Impression - Severity scale (CGI-S). The patients~     were randomly classified into three equal groups using closed envelop: 1st group received 1~     Hz rTMS at 100% of the RMT, 2nd group received 10 Hz rTMS with intensity of 100% of the RMT~     and 3rd group was sham group received the sham stimulation with a total 2000 pulses every day~     for each group for 10 sessions. Follow up of the patients using the same previous scales~     after the end of sessions and 3 months later.~   "
80641|NCT02511379|"~     The purpose of this study is to evaluate the efficacy and safety of Systane® Balance~     following 90 days of QID (4 times/day) dosing among Indian subjects with dry eye. This study~     will be conducted in India.~   "
80663|NCT02511093|"~     The purpose of this study is to determine whether a team-based care (TBC) intervention,~     combining physician, nurse and pharmacist care improves BP control compared to usual care at~     6 months among outpatients with uncontrolled hypertension.~   "
80642|NCT02511366|"~     The appearance of intact macronutrients in the small intestine induces an intestinal brake; a~     negative feedback mechanism from different parts of the intestine to the stomach, the small~     intestine and to the central nervous system. These processes inhibit food processing,~     appetite sensations and food intake, and furthermore they increase feelings of satiety and~     satiation. Several studies showed that intraileal infusion of nutrients resulted in a~     reduction in food intake. However only acute effects were investigated in these studies and~     thus far it is not known whether repetitive (intermittent) infusion results in adaptation to~     repeated exposure and, thus, a lowered ileal brake response.~   "
80643|NCT02511353|"~     In western Kenya the prevalence of malaria in <5 year olds has fallen from 70% in 1997 to 40%~     in 2008, where it has now stagnated. Innovative approaches are needed to continue towards~     elimination. Ivermectin is a broad spectrum antiparasitic endectocide widely used for the~     control of onchocerciasis and lymphatic filariasis at a dose of 150-200 mcg/kg. Ivermectin at~     this dose has a potent, but short-lived effect for 6-11 days on mosquito survival,~     egg-laying, and parasite sporogony. Higher doses are needed to prolong its mosquitocidal~     effects. Previous studies have shown ivermectin is very well tolerated and safe even up to~     2,000 mcg/kg. This dose finding study will evaluate the transmission blocking effect of~     high-dose ivermectin to define the optimal dose for future use of ivermectin in combination~     with artemisinin-based combination therapy (ACT) for mass drug administration (MDA). It~     explores a research question of global relevance. A prolonged transmission blocking effect of~     ivermectin could have substantial consequences for malaria control in the next decades. The~     results are expected to inform national malaria control programs in malaria endemic~     countries, to inform WHO guidelines, and to contribute to the regulatory process.~   "
80644|NCT02511340|"~     Multi-center, single stage, phase II study to evaluate the efficacy and safety of Flumatinib~     in accelerated or blastic Phase chronic myelogenous leukemia patients.~   "
80645|NCT02511327|"~     Young infants are most vulnerable to severe disease and even death when infected with~     Bordetella Pertussis. The current vaccines and vaccination programs do not guarantee~     protection of neonates. During the last weeks of pregnancy, maternal IgG antibodies are~     transferred actively to the fetus. Administration of a pertussis containing vaccine during~     pregnancy offers protection through high titers of maternal antibodies transferred to the~     child. Since transplacental transport is immature, infants who are born prior to 37 weeks of~     gestation, might be vulnerable to pertussis infection even though maternal vaccination was~     administered, but specific data are lacking. The primary aim of this observational study is~     to measure whether vaccination during pregnancy offers protection to preterm born infants~     through higher titers of maternal antibodies, despite immature transplacental transport. Four~     cohorts of mother-infant pairs will be recruited: term versus preterm born infants, born from~     either vaccinated women or not vaccinated women. These mother-infant pairs are recruited~     according to the vaccination status of the mother and to the gestational age at delivery.~     Pertussis specific antibody titers (anti-Pertussis Toxin, anti-Filamentous haemagglutinin,~     anti-Pertactin titers) will be monitored in blood samples of the mothers at delivery to~     measure the possible influence of both gestational age and maternal vaccination status. In~     order to measure the decline of maternal antibodies in the first weeks of life, blood will be~     taken from cords as well as from infants at 8 weeks of age, before the first infant pertussis~     vaccine is administered.~      Pertussis antibodies to the same antigens will be measured in all infants after a primary~     series of acellular pertussis vaccines administered at 8,12 and 16 weeks of age and before~     and after a booster dose in the second year of life.~      In addition, cellular mediated immune responses will be evaluated in a subgroup of infants~     before and after a primary series of infants vaccines. A last goal is to measure whether~     vaccination during pregnancy could offer additional maternal antibodies through breast milk.~     Again a comparison is made between preterm and term born infants, born from either vaccinated~     or unvaccinated women. The amount of lactoferrin and pertussis toxin specific IgA in breast~     milk samples will be measured in samples taken at birth (colostrum), and at several time~     points afterwards as long as breastfeeding is continued.~   "
80646|NCT02511314|"~     The purpose of this study is to compare the use of an electronic incontinence identification~     system with nursing home support (Tena Identifi) versus usual care on the quality, resource~     use and outcomes of continence care for older residents of nursing care homes.~   "
80647|NCT02511301|"~     The purpose of this study is to determine if Cyrcadia's Circadian Biometric Recorder (CBR™),~     which is attached to soft biometric patches worn on the body, can improve early breast cancer~     detection along with mammography or as a stand alone device.~   "
80648|NCT02511288|"~     The goal of this project is to create a biological collection of blood samples from patients~     with advanced stage IIIB/IV non-small cell lung cancer (NSCLC) with clinical annotations.~   "
80649|NCT02511275|"~     Surgery plays a central role in kidney cancer management being the only therapy that offers~     the possibility of healing the patients. Currently, the partial nephrectomy is a standard~     technique because it meets the principle of nephron sparing surgery. A partial nephrectomy~     requires a control of the renal blood flow using a clamp, which can be parenchymal or~     vascular (pedicular). In France, most of the centers use pedicular clamping. It is well~     established that this technique results in warm ischemia of the entire healthy parenchyma and~     can lead to permanent kidney damages. Currently, no study evaluated the impact of parenchymal~     clamping on the healthy parenchyma.~      The aim of the investigators study is to evaluate the nephrotoxicity of the healthy~     parenchyma due to parenchymal clamping during partial nephrectomy. This assessment will be~     done through a microdialysis technique. The microdialysis probe is directly implanted in the~     healthy unclamped parenchyma and will allow us to measure in real time, during the surgery,~     the biological changes related to anaerobic metabolism of renal interstitial space. All those~     measures will be completed by urinary and plasmatic assessments. Oxidative stress will be~     assessed using four markers of tubular viability : Interleukin 18 (IL18), Kidney Injury~     Molecule-1 (KIM-1), Neutrophil Gelatinase-Associated Lipocalin (NGAL) and cystatin C and four~     parameters of anaerobic metabolism : lactate, pyruvate, glycerol and glucose.~      This is a prospective pilot study limited to 10 patients included over 12 months. Depending~     on the results, it will be further developed by a second study comparing parenchymal with~     pedicle clamping.~   "
80650|NCT02511262|"~     The objective of this Clinical Trial is to define the methods to be used to document that~     illumigene® Mycoplasma Direct meets its intended use claims, using the illumipro instrument,~     with throat swab samples collected from symptomatic patients.~   "
80664|NCT02511080|"~     Using the spot-on device for monitoring core body temperature during colon laparoscopic~     surgery and prevent non-therapeutic hypothermia.~   "
80665|NCT02511067|"~     The purpose of this study is to investigate the safety, tolerability and efficacy of~     Ranibizumab and Tocilizumab alone and in combination in eyes with Diabetic Macular Edema.~   "
80688|NCT02510768|"~     The study is designed to evaluate the efficacy of two formulations of a cross-linked~     tropoelastin matrix given the product codes ELAPR002f and ELAPR002g (collectively referred to~     as ELAPR or ELAPR002) for the treatment of Striae Distensae (SD) alba when administered as~     intradermal implants.~   "
97987|NCT02284659|"~     Objective: The aim of this study is to evaluate the FES effect on erectile function in men~     with erectile dysfunction.~      Expected Results: The hypothesis is that treatment with FES decrease erectile dysfunction.~   "
80651|NCT02511249|"~     While perinatal ischemic stroke is the most frequent form of childhood stroke, early~     determinants of outcome remain poorly understood. Two main structural biases limit the~     accuracy of most studies: heterogeneity of the population and short follow-up.~      Perinatal ischemic stroke includes several conditions that differ in pathophysiology and~     timing of occurrence. Yet, it is not surprising that risk factors and outcome depend~     primarily on the type of stroke. Age at evaluation also plays a major role after a neonatal~     insult. Even though the original lesion is static and focal in perinatal stroke, its~     consequences grow over time within the maturing brain and affect all fields of~     neurodevelopment.~      The objective of the AVCnn study was to delineate the determinants, clinical and imaging~     presentation, mechanism, and long term outcome of a category of perinatal stroke (neonatal~     arterial ischemic stroke: NAIS). This led to the AVCnn cohort, which now gives us the~     opportunity to regularly monitor a large cohort of children having suffered an NAIS.~   "
80652|NCT02511236|"~     The importance of reducing tobacco-associated health disparities between cannot be~     understated. Racial/ethnic minorities are less likely to quit, and tend to have elevated~     stress and depressive symptoms, which may contribute to cessation disparities. Cognitive~     behavioral therapy (CBT) for cessation addresses these concerns and has the potential to~     reduce/eliminate disparities. Preliminary research found racial/ethnic differences in~     baseline perceived stress and depressive symptoms. Following CBT, these differences were no~     longer present. Moreover, compared to Whites, African Americans exhibited blunted~     hypothalamic-pituitary-adrenal (HPA) axis functioning. This randomized controlled trial (RCT)~     will be the first to test the impact of CBT on smoking cessation disparities. The specific~     aims are to: (1) Examine the effects of CBT on perceived stress and depressive symptoms in a~     racially/ethnically diverse sample; (2) test the efficacy of CBT for eliminating smoking~     cessation disparities; and (3) examine physiological distress as an underlying mechanism for~     the effects of CBT on racial/ethnic minority smokers (exploratory). It is hypothesized that~     CBT will eliminate racial/ethnic differences in distress symptoms compared to the general~     health education (GHE) control group. A condition and race/ethnicity interaction on 7-day~     point prevalence abstinence (ppa) is also expected, with no racial/ethnic differences in~     cessation in the CBT condition only. It is also hypothesized that HPA functioning will~     mediate the effect of CBT on smoking cessation, particularly among racial/ethnic minorities.~     This study has implications for eliminating disparities in psychosocial factors related to~     cessation, and disparities in success. Addressing stress and depressive symptoms through CBT~     may facilitate cessation, particularly among racial/ethnic minorities.~   "
80653|NCT02511223|"~     This is an open label, single arm, phase II trial of Olaparib for PDAC patients with~     BRCAness. All study subjects will receive Olaparib in a dose of 300 mg p.o twice daily.~     Treatment will continue until progression, intolerable toxicity or as per patient preference.~      Primary objective:~      To determine the efficacy of Olaparib monotherapy in stage IV pancreatic ductal~     adenocarcinoma (PDAC)with BRCAness (BRCA-Breast Cancer susceptibility gene).~   "
80654|NCT02511210|"~     The researchers aimed to investigate that preoperative anxiety scores of patients who are~     informed about the anesthesia before surgery with using State-Trait Anxiety Inventory and~     Amsterdam preoperative anxiety and information scale tests together.~   "
80655|NCT02511197|"~     This is an open-label positron emission tomography/computed tomography (PET/CT) study to~     investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-PRGD2 in lung~     injury (LI) and pulmonary fibrosis (PF) patients. A single dose of nearly 111 MBq~     68Ga-NOTA-PRGD2 (≤ 40 µg NOTA-PRGD2) will be intravenously injected into patients with LI/PF.~     Visual and semiquantitative method will be used to assess the PET/CT images.~   "
80656|NCT02511184|"~     The purpose of this study has 2 phases, a Dose Finding Phase will determine the maximum~     tolerated dose . The Dose Expansion Phase will explore the safety, tolerability, and~     anti-tumor activity of the combination.~   "
80657|NCT02511171|"~     The aim of this research is to assess the acceptability of using a mobile folding screen for~     blinding parents of infant study participants in clinical trials of osteopathic~     interventions. The preliminary data of this acceptability study will inform future randomized~     controlled trials with infant participants where parental blinding is required. 30~     excessively crying infants will be randomly allocated to 2 groups, one group receives~     osteopathic intervention, the other group does not receive treatment. All infants are treated~     (or not) behind a mobile folding screen, so that parents are not aware of group allocation.~     After a 'treatment' period of 20 min, the screen is removed, and parents are asked to fill in~     an acceptability and blinding success questionnaire.~   "
80658|NCT02511158|"~     In this study we will examine patients who have undergone anterior cruciate and/or posterior~     cruciate ligament and/or multi ligaments reconstruction to determine the rate of re-injury,~     contralateral tear and functional outcomes at least two years after surgery.~   "
80659|NCT02511145|"~     Exploratory, mono-center, randomized, intra-individual, controlled trial involving healthy~     volunteers to compare the effect on MAL penetration into the skin following various~     mechanical penetration enhancement techniques.~   "
80660|NCT02511132|"~     Based on the limited accrual to Part 1 of this study, Gradalis is opening Part 2 of this~     clinical protocol to assess the safety of Vigil immunotherapy in combination with irinotecan~     and temozolimidetemozolomide. Part 2 will be conducted at the same centers as Part 1,~     studying intradermal autologous Vigil cancer vaccine (1.0 x 10e7 cells/injection; minimum of~     4 to a maximum of 12 administrations) in patients with metastatic Ewing's sarcoma Family of~     Tumors (ESFT) refractory or intolerant to at least 1 prior line of chemotherapy. Patients~     undergoing a standard surgical procedure (e.g., tumor biopsy or palliative resection) may~     have tumor tissue harvested for manufacture of investigational product. Patients meeting~     eligibility criteria including manufacture of a minimum of 4 immunotherapy doses of Vigil~     will be registered to receive: (i) oral temozolimidetemozolomide 100 mg/m2 daily (Days 1 - 5,~     total dose 500 mg/m2/cycle), (ii) irinotecan 50 mg/m2 daily (Days 1 - 5, total dose~     250mg/m2/cycle), orally or irinotecan 20mg/m2 daily (Days 1 - 5, total dose 100mg/m2/cycle),~     intravenously (iii) peg-filgrastim 100μg/kg (Day 6) subcutaneously (optional and may be~     administered at home), and (iv) Vigil 1.0 x 10e7 cells/injection, intradermally on Day 15 and~     every 3 weeks thereafter. One cycle = 21 days.~   "
80661|NCT02511119|"~     The aim of this study is to develop a predictive model of risk of developing melanoma. The~     investigators will used artificial intelligence techniques to analysed images patterns~     obtained by clinical and dermoscopic pictures. The investigators want to defined a new~     predictive risk model obtained from genetic information and image analysis of pigmented~     lesions. This model could help to discriminate more accurately those patients who are most~     likely to develop melanoma in a high-risk population.~   "
80662|NCT02511106|"~     To assess the efficacy and safety of AZD9291 versus Placebo, in patients with Epidermal~     Growth Factor Receptor Mutation Positive stage IB-IIIA non-small cell lung carcinoma,~     following complete tumour resection with or without adjuvant chemotherapy~   "
80666|NCT02511054|"~     Background:~      - Malaria is a severe infection caused by a parasite. People can get malaria if a mosquito~     that carries the parasite bites them. Although malaria does not occur in the United States,~     many people in Africa, Asia, and South America do get malaria. In some cases, malaria can~     cause death. In 2013 alone, 584,000 people died due to malaria. Researchers want to find ways~     to prevent and treat malaria.~      Objective:~      - To find out if combining live, infectious malaria parasites (known as Sanaria PfSPZ~     Challenge) and two FDA approved drugs that kill malaria parasites (pyrimethamine [PYR] and~     chloroquine [CQ]) is safe and can provide people protection against malaria. The Sanaria~     PfSPZ Challenge has been used in other studies without significant side effects.~      Eligibility:~        -  Healthy people ages 18-50 who weigh less than 170 pounds and are not pregnant or~          breastfeeding~        -  No history of hepatitis B, hepatitis C, or HIV infection~        -  Not currently enrolled in a clinical trial that involves a research drug or vaccine~        -  Have not traveled to an area with high malaria transmission within the last 5 years~        -  Never diagnosed with malaria in the past~      Design:~        -  Participants will be in 1 of 4 groups.~        -  Participants will receive a combination of injections and drugs. What combination they~          will receive will depend on what group they are in. This combination of injections and~          drugs may include:~             -  Injections of Sanaria PfSPZ Challenge (live, infectious malaria parasites) into a~               vein~             -  FDA approved antimalarial drug called chloroquine (CQ)~             -  FDA approved antimalarial drug called pyrimethamine (PYR)~             -  FDA approved antimalarial drug called Malarone~             -  The study will last approximately 3-7 months (depending on which group participants~               are in).~        -  There will be up to 68 study visits for three groups. One group will have up to 27 study~          visits. During the study visits, participants may have:~             -  Medical history review~             -  Physical exams~             -  Electrocardiogram (ECG): soft electrodes will be placed on the skin. A machine will~               record the heart s electrical signals to evaluate heart function.~             -  Blood and urine tests~             -  Medication given in the clinic under direct observation~             -  Injection of Sanaria PfSPZ Challenge into a vein~             -  Participants will receive a diary, thermometer, and ruler to record their body~               temperature and any symptoms.~   "
80667|NCT02511041|"~     Background:~      - A congenital disorder of glycosylation (CDG) affects the cells that make up the organs and~     tissues. In these cells, sugar molecules do not properly attach to other molecules, which are~     the basic building blocks of cells. Changes in sugars seen in people with CDGs may lead to~     allergies and can change people s ability to fight infections. Researchers want to see if a~     sugar supplement called N-acetylglucosamine can help people with CDGs who have detectable~     changes in their immune systems.~      Objective:~      - To see if N-acetylglucosamine can help cells to function in a healthy way in people with~     CDGs.~      Eligibility:~      - People at least 2 years of age who have a CDG and immune system changes.~      Design:~        -  Participants will be screened with a physical exam, medical history, and blood tests.~        -  One month later, participants will repeat the blood tests from the screening visit.~          Blood will be drawn on 2 different days in the same week.~        -  Participants will get N-acetylglucosamine supplements and instructions for how to take~          them. N-acetylglucosamine is a powder that can be added to food or drink.~        -  Participants will have a physical exam and blood tests every month during the study.~        -  After taking N-acetylglucosamine for about 4 months, participants will have more blood~          tests. They will get more N-acetylglucosamine supplements and a nucleoside supplement.~          The second supplement may be a powder or tablets that may be crushed and added to food.~          Participants will take both supplements for 5 months.~        -  After about 10 months in the study, participants will have 2 more visits in the same~          week for the same blood tests.~   "
80668|NCT02511028|"~     Background:~      - Contrast agents help things show up better on magnetic resonance imaging (MRI) scans.~     Researchers want to see if the drug ferumoxytol is a good contrast agent. They want to~     determine that it does not cause prolonged MRI changes in the brain and to see if it helps~     identify inflammation in multiple sclerosis~      Objective:~      - To learn how ferumoxytol can be used to image inflammation in multiple sclerosis (MS).~      Eligibility:~        -  Adults ages 18 70 who have MS.~        -  Healthy volunteers ages 18 70.~      Design:~        -  Participants will have 5 clinic visits over 6 months.~        -  Participants will be screened with a medical history, neurological exam, and blood draw.~          Full clinical measures will be obtained.~        -  Participants will have a 7 tesla brain MRI scan that may include gadolinium contrast~          agent. The MRI is a metal cylinder in a strong magnetic field. The participant will lie~          on a table that can slide in and out of the cylinder.~        -  During visit 2, ferumoxytol with be given through a catheter (a thin plastic tube) that~          is inserted with a needle into a vessel in the arm.~      <TAB>- Participants will then have a 7 tesla MRI scan of the brain..~        -  At each of the next 3 clinic visits, participants will have a 7 tesla brain MRI and have~          blood drawn. The MRIs may include gadolinium.~        -  Participants may have a full neurologic exam at these visits. At the final visit, full~          clinical measures will be obtained.~        -  Participants may have more MRI scans if a 6-month MRI shows ferumoxytol still in the~          brain.~   "
80669|NCT02511015|"~     Background:~      - Parkinson s disease is a disease of the nervous system that affects movement. People~     usually get it in their 70s or 80s. Early onset Parkinson s disease (EOPD) begins before the~     age of 50. Researchers think EOPD may be caused by a mutation in a gene. They want to study~     the genetic causes so they can find therapies for this disease.~      Objective:~      - To better understand the genetic causes of EOPD.~      Eligibility:~        -  Adults ages 18 80 with a history of EOPD. Their family members, who do not have~          Parkinson s disease, can join as controls.~        -  Healthy volunteers ages 18 80.~      Design:~        -  Participants with EOPD and their relatives will be screened with a review of medical~          records. Healthy volunteers will have medical history, physical exam, and blood drawn.~        -  Relatives may send blood samples to NIH to test for mutations in genes that are linked~          to Parkinson s disease. They may have a physical exam.~        -  Participants may be asked to return to clinic for another visit that can last up to 2~          hours.~        -  During this visit, participants will have blood taken from a vein in the arm via a~          needle stick.~        -  Participants may give a sample of their skin. The skin on the arm or leg will be numbed~          and a small skin punch biopsy will be taken with a special needle.~        -  Some cells from the blood or skin sample may be grown in a lab to establish cell lines.~          The cells may also potentially be genetically modified to make stem cells.~        -  Researchers may perform genetic analysis on the samples to compare them to EOPD patient~          samples.~   "
80684|NCT02510820|"~     This will be a controlled and randomized, single-masked, crossover study in which 48 subjects~     will use the Biofinity Contact Lens (comfilcon A) with each of the two lens care products~     ('solutions'), (Synergi and Biotrue Multi-purpose Solution) for one month each. Follow-up~     visits for each solution will take place at one week, two weeks and four weeks: with a~     one-week 'wash-out' period between the solutions. Key outcome measures for this study include~     biomicroscopic and subjective responses to the lens/solution combinations.~   "
80750|NCT02509962|"~     To study the effects of an increased salt intake on metabolic, cardiovascular and~     immunoregulatory functions in healthy men.~   "
97988|NCT02284646|"~     Purpose: to assess the efficacy of a physical training program in patients with ankylosing~     spondylitis (AS) in a randomized controlled study~   "
80670|NCT02511002|"~     Background:~      - Influenza is a common viral infection. But it can be deadly for some people. Researchers~     want to learn more about how the body fights this virus. They want to study this in people~     who have recently been infected with influenza. They hope this can help them create more~     effective influenza vaccines.~      Objective:~      - To learn about long-term changes in the body s immune system after influenza infection.~      Eligibility:~      - People who have completed a previous LID Clinical Studies Unit influenza challenge study~     and are willing to have samples stored for future research.~      Design:~        -  Eligible participants will be asked to visit the clinic every 3 months for 2 years.~        -  During each visit, participants will have blood drawn from an arm vein using a needle~          and a syringe.~        -  Participants will have a medical history and physical exam and vital signs performed.~          This will include blood pressure, heart rate, breathing rate, temperature, weight, and~          finger-measured blood oxygen. They will answer questions about any medicines taken and~          possible recent illnesses.~        -  If participants have symptoms of influenza, they may have a sample taken from the nose.~          A small <TAB>amount of salt water will be sprayed into the nostril with a squeezable~          container. The salt water will then run out of the nose and into the container. Or the~          inside of the nose will be wiped with a swab that is~      similar to a Q-tip.~      - Participants will complete a health questionnaire once a month on a secure website.~     Participants may also give their responses over the telephone.~   "
80671|NCT02510989|"~     Syndromic obesity are rare forms of obesity (1% of cases), involving severe obesity and early~     to multi organ involvement (mental retardation, dysmorphic, sensorineural damage and / or~     endocrine). To date, the genetic defects are identified in only 5% of cases (Prader-Willi~     syndrome, Bardet-Biedl syndrome, mutation of leptin or its receptor, the proconvertase-1,~     proopiomelanocortin or SIM-1 and TRKB genes, high resolution karyotype or abnormal DNA chips,~     ...). Precocity and severity of obesity are those for a little dependent genetic environment.~      The investigators aim is to identify new gene variants in subjects with syndromic obesity~     sharing common phenotypic features.~   "
80672|NCT02510976|"~     Controlled cross-over study of prucalopride 2 mg daily or placebo in gastroparesis~     (idiopathic or diabetic). Patients will be randomized to 4 week treatment with the first~     regimen (double-blind), followed by a 2-week washout and 4 week treatment with the second~     regimen in cross-over.~   "
80673|NCT02510963|"~     To determine the optimal time for the Tenofovir treatment of anti-Hepatitis B Virus (HBV)~     during the pregnancy among women with chronic HBV infection and high HBV DNA load. This is a~     randomized, open-label, three-arms, parallel-controlled clinical trial. Pregnant women with~     high HBV load and normal liver function will be treated with tenofovir during the middle or~     late stage of pregnancy, started from 24th gestational week, 28th gestational week and 32th~     gestational week through 1 month postpartum, respectively. The HBV DNA load at 40th~     gestational week of mothers, the intrauterine HBV infection rate of infants will be compared~     across the three groups.~   "
80674|NCT02510950|"~     The early clinical development paradigm for chemotherapeutic agents has significantly~     influenced the development of therapeutic cancer vaccines. However, there are major~     differences between these two classes of therapeutics that have important implications for~     early clinical development. Specifically, the phase 1 concept of dose escalation to find a~     maximum-tolerated dose does not apply to most therapeutic cancer vaccines. Most therapeutic~     cancer vaccines are associated with minimal toxicity at a range that is feasible to~     manufacture or administer, and there is little reason to believe that the maximum-tolerated~     dose is the most effective dose.~      In a recent article from the biostatistics literature, Simon et al. write that the initial~     clinical trial of many new vaccines will not be a toxicity or dose-ranging trial but rather~     will involve administration of a fixed dose of vaccine … in most cases the dose selected will~     be based on preclinical findings or practical considerations. Using several dose levels in~     the initial study to find the minimal active dose or to characterize the dose-activity~     relationship is generally not realistic.~      Consistent with these recommendations, the general philosophy of the phase 1 clinical trial~     is to facilitate a prompt preliminary evaluation of the safety and immunogenicity of the~     personalized synthetic long peptide vaccine strategy. The proposed clinical trial will test a~     fixed dose of vaccine. There is considerable experience with the synthetic long peptide~     vaccine platform. The synthetic long peptide vaccine platform has an excellent safety~     profile, and the optimal dose appears to be based on practical considerations (solubility of~     the peptide). The dose to be tested in the proposed clinical trial is consistent with other~     similar cancer vaccine trials that have been recently completed or are currently ongoing. The~     sample size (n=10) will provide a reasonably reliable estimate of the safety and~     immunogenicity of the vaccine.~   "
80675|NCT02510937|"~     Participation in the study will last for 3months, with a 1 month screening phase.~   "
80676|NCT02510924|"~     Airtraq sp has been proven effective for intubating patients presenting with difficult~     airway.~      The Airtraq sp allows visualisation of the tracheal inlet only for the intubator.~      By adding a smartphone with a dedicated app (Airtraq Mobile) to the Airtraq sp, the~     visualisation of the tracheal inlet is possible for all the airway providers.~      The investigators aim to demonstrate that the addition of the Airtraq Mobile app improves~     success rate of intubation (primary endpoint), as well as confort of the airway provider,~     shortens time for intubation and reduces injury to the patients.~   "
80677|NCT02510911|"~     Postoperative bowel paralysis is common after abdominal operations, including colectomy. As a~     result, hospitalization may be prolonged leading to increased cost. A recent randomized~     controlled trial from the University of Heidelberg showed that consumption of regular black~     coffee after colectomy is safe and associated with a significantly faster resumption of~     intestinal motility (Müller 2012). The mechanism how coffee stimulates intestinal motility is~     unknown but caffeine seems to be the most likely stimulating agent.~      Thus, this trial addresses the question: Does caffeine reduce postoperative bowel paralysis~     after elective laparoscopic colectomy?~      Patients after laparoscopic colectomy will receive either 100 mg caffeine, 200 mg caffeine,~     or 250mg corn starch (placebo) 3 times daily in identically looking gelatin capsules.~      The study is a randomized, controlled trial, with blinding of physicians, patients and~     nursing stuff (evaluating the endpoints).~      Primary endpoint will be the time to first bowel movement.~   "
80685|NCT02510807|"~     The literature has shown that supervised exercise programs for patients with PAD and who~     report intermittent claudication (IC) have improved health outcomes, but this is not locally~     available. Introducing the use of a pedometer may act as a method to encourage patients to~     continue on their independent exercise regimen. There is very little literature which has~     examined the effectiveness using pedometers as a measure of compliance within this~     population.~   "
80686|NCT02510794|"~     This is a Phase II clinical study to evaluate the efficacy, safety and pharmacokinetics of~     three different formulations of ranibizumab delivered via RPDS implant compared with the~     standard of care (SOC) intravitreal (ITV) injections of ranibizumab, in participants with~     subfoveal neovascular AMD.~   "
80678|NCT02510898|"~     The purpose of this study is to determine whether a 6-week writing to heal~     seminar/workshop/class, Transform Your Life: Write to Heal, raises resilience scores as~     measured by the Connor-Davidson Resilience Scale for people who have recently experienced an~     emotional or physical trauma.~      Eligible subjects will be adults who self-identify as having had a recent emotional upheaval~     or physical health challenge. Potential subjects will be recruited through the use of flyers,~     advertisements, and emails to the Duke Integrative Medicine email list. Subjects will~     complete pen and paper measures at baseline and immediately post-treatment, including: the~     Connor-Davidson Resilience Scale, the 10-item Perceived Stress Scale, The 20-item Center for~     Epidemiological Studies Depression Scale, the 22-item Rumination Response Scale, and a~     baseline questionnaire.~      The investigators aim to target a sample of 30 completers by enrolling 37 participants. The~     risks of participation in this study are minimal, and include temporary sadness after the~     initial writing experience.~   "
80679|NCT02510885|"~     The objective of this study is to image retinal vascular alterations in patients with retinal~     disease using the AngioVue OCT-A system and understand the information these images provide.~     The investigators will image study participants who have retinal diseases with the AngioVue~     unit (Optovue) and will collect relevant clinical data to understand the nature of the~     information contained in images obtained on AngioVue. This study being conducted under an~     abbreviated IDE. The investigators will analyze data using descriptive statistics. Risks~     related to light exposure will be managed by ensuring that the exposure to the AngioVue light~     source is well below maximum permissible limits for safe exposure.~   "
80680|NCT02510872|"~     Early detection of viable residual tumor or early neoplastic recurrence represents a real~     challenge in monitoring patients treated with concomitant chemoradiotherapy squamous cell~     carcinoma of the upper aerodigestive tract.~      The locoregional recurrence rate is indeed high (up 40%) over the first two years of this~     therapeutic method.~      The conventional imaging methods such as CT and MRI appear limited in terms of sensitivity~     because of the many post-treatment changes are fibrosis, tissue edema and the tissue~     distortion.~      PET-CT 18F-FDG proves to be a non-invasive, reliable for the detection of residual tumor and~     metastasis, even in the absence of clinical signs.~      To date, the acquired CT examination in the same time and in the same position that PET is~     performed without iodinated contrast injection, used for anatomical identification and~     attenuation correction of PET fused images. The patient usually has a second CT imaging,~     centered on the neck with contrast injection iodized within the radiology department.~      To date, no team has yet studied the interest of the PET-CT 18F-FDG coupled with a CT scan~     with contrast injection iodized in the diagnosis of early recurrence in head and neck~     malignancies while interest of the contrast agent injection has been demonstrated in ovarian~     neoplastic recurrence research, pancreatic and colon.~   "
80681|NCT02510859|"~     Malnutrition is currently a major factor of morbidity and mortality, which poses a major~     public health problem in developing countries but also, albeit to a lesser degree and for~     different reasons, for industrialized countries. It is recognized that in countries of the~     North, from 30 to 60% of hospitalized patients suffer from dénutrition.~      In any case, it is covered by an imbalance between the contributions and needs; the two main~     mechanisms are a delivery failure (fasting, ingesting difficulty ...) and / or increased~     requirements (hypermetabolism ...). In cancer patients the Aero-Digestive Upper Airways~     (VADS), this imbalance is even more pronounced than the two mechanisms exist and potentiate.~     Patients included in this study are a population at risk, because of their therapeutic~     containing at least radiotherapy. It is recognized that this form of therapy exposes dental~     complications, mucous, saliva. These complications have a deleterious effect on the~     nutritional status of patients.~      The diagnosis, treatment and prevention of dénutritions have an important place in the~     therapeutic strategies of this type of cancer because it is events whose incidence and morbid~     consequences are high and for which there are appropriate nutritional treatments in most cas.~     While the complete correction of malnutrition generally passes by the effective etiological~     treatment of the causal pathology, therapeutic efficacy of the latter is often conditioned by~     the nutritionnel state.~      In addition to these concepts, investigators wants to study the benefits of a diet followed~     during the irradiation phase of patients with head and neck cancers and New treaties. We~     propose a randomized, phase III, open, multicenter, to evaluate the impact of a dietary~     consultation at home on the life quality of patients with head and neck cancer including~     first therapeutic sequence involves radiotherapy more or less aware. The duration of the~     study is 24 months.~      The main objective is to evaluate the impact of a dietary consultation at home on the life~     quality of patients with head and neck cancer including first therapeutic sequence involves a~     more or less sensitized radiotherapy.~   "
80682|NCT02510846|"~     Profound multiple disabilities also called in French polyhandicap are defined by the~     combination of a deep mental disability and severe motor deficit with extreme restriction of~     autonomy. Life in institution for people with profound multiple disabilities induces~     emotional and educative deficiency and often conducts to behavioral disorders. These~     behavioral disorders also impact on quality of life and feelings of caregivers. An intensive~     multimodal educative program proposed to patients with profound multiple disabilities can~     improve their psychic well-being, reduce chronic pain and improve also quality of life and~     feelings of caregivers. The intensive multimodal educative program will be compared to the~     usual practice of educative program.~   "
80683|NCT02510833|"~     Parkinson's disease (PD), neurodegenerative and common from 50 to 60 years, is characterized~     by rigidity, bradykinesia and resting tremor that can interfere in the quality of life. To~     maintain or improve this, there is the physiotherapy. Problems in access, such as walking and~     financial difficulties, make home exercises target of interest. The study aims to assess the~     impact of a program of home therapeutic exercises, with individualized approach and remote~     monitoring by physical therapist, about signs and symptoms of Parkinson's disease and quality~     of life. This is a randomized controlled clinical trial, conducted at the Program~     Pró-Parkinson of the Clinics Hospital, Federal University of Pernambuco, Neurology Clinic.~     Will be included people of both sexes (50 years) with idiopathic PD, stages 1-3 in Hoehn &~     Yahr original; non-institutionalized and independent walking. It will be applied before and~     after 12 weeks of intervention (period ON of medication): Survey about Knowledge, Attitudes~     and Practice; Questionnaire of Accession; Unified Scale Evaluation of Parkinson's disease~     (UPDRS) - subscales II and III; and Parkinson's Disease Questionnaire 39 (PDQ-39).~     Participants will be randomized into two groups: Group continued intervention (GIC) and~     control group (CG). The GIC will have an meeting with individualized approach (physical~     therapist, patient and companion) for guidance on home physical therapy exercises, using the~     Manual Pró-Parkinson, then the participant will receive the manual with stretching exercises,~     mobility, balance and strength, which will lead to your home as a way to guide their~     activities; and receive weekly follow-up by phone calls (to remember the exercises, answer~     questions and encourage the continued practice). GC may be attend presentations on home~     exercises of the Pro-Parkinson's manual in the days of your query and have the same manual~     without remote follow-up by phone calls, usual service procedure. Exercises are oriented to~     be performed three times a week for 12 weeks and under the effect of anti-Parkinson~     medication. This study will contribute new evidence on the effects of a rehabilitation~     program available and inexpensive based on home exercises.~   "
80687|NCT02510781|"~     Docetaxel plus carboplatin and trastuzumab has been a standard treatment for patients with~     human epidermal growth factor receptor-2（HER-2）positive. The investigators witnessed a higher~     pathological complete remission(pCR) rate but no obvious increase in cardiac toxicity when~     used the anthracycline instead of carboplatin. The investigators expect to carry out a large~     sample size clinical research to optimize the existing therapeutic regimen~   "
80689|NCT02510755|"~     A broad group of disorders is associated with severe stress existence in children or~     adolescents. The most characteristic result, and one of the most serious being the state of~     post-traumatic stress disorder (PTSD), whose main source consists of physical or sexual~     violence, and to a lesser extent, accidents public road or natural disaster, whose child was~     the subject or witness. PTSD is associated with a deleterious effect on cognition and~     including the mnemonic operation. The painful reminder of the traumatic event is one of the~     most disabling symptoms. However, there are many other memory disorders that experimental~     studies gradually update. They maintain a close link with emotional regulation that disturbed~     you know if PTSD. However the majority of studies on emotion and cognition and their~     relationship with brain activity took adult subject. Work in adolescents are few on the~     morphological study, on rare neurobehavioral and reduced to two studies of functional~     neuroimaging. Contrary to what is observed in adults, morphological studies report~     consistently, no reduction in hippocampal volume. There is no study in the idle state. Two~     studies in functional MRI, the first highlighted in PTSD patients inhibition of the activity~     of the anterior cingulate cortex (ACC) to stimuli such as to evoke the trauma, a second~     reported increased activity in the prefrontal cortex Median (mPFC) in a inhibition. The~     objective task of our study is to evaluate the impact of psychological trauma on brain~     structures involved in the emotional component of the memory (amygdala, hippocampus,~     prefrontal cortex in particular). For this, the investigators will take in 33 adolescents,~     including patients with posttraumatic symptomatology and matched controls free of trauma age,~     several neuroimaging exams, anatomical and functional. The functional review will include~     some rest and another in activation during episodic memory task designed to assess the~     influence of self-perception on memory impairment observed in patients. The investigators~     will check, for each group of patients and controls, the involvement of cortical structures~     in relation to the regulation of emotional memory (CCA, amygdala and hippocampus). The~     anatomy of the hippocampus benefit specific imaging methods developed in the unit INSERM~     U923. Endocrine correlates of stress tests will be studied by a fully-traumatic by salivary~     cortisol sampling.~      This research will clarify the mechanisms involved in emotional and memory impairments~     secondary to psychological trauma, their relationship with self (judgment and self-esteem)~     and studying their morphological substrates. A longer-term goal is to offer help in the~     diagnosis and monitoring of young patients with posttraumatic symptomatology.~   "
80690|NCT02510742|"~     Hypothesis:~      Stimulation of the SPG at low frequencies (20 Hz)is believed to cause a physiological~     parasympathetic upregulation which increases VMCA, concentration and cephalic vessel~     diameter.~   "
80691|NCT02510729|"~     We hypothesized that LF stimulation of the SPG would increase parasympathetic outflow,~     activate sensory afferents and provoke a cluster-like attack.~   "
80692|NCT02510716|"~     The purpose of this study is to evaluate the feasibility, acceptability and preliminary~     efficacy of a Scheduled Gradual Reduction (SGR) intervention via SMS (short message service)~     text messaging plus SMS Support Messages in decreasing smoking in an older adult rural~     population. The SGR group (n=20) will receive a four-week SGR program delivered via SMS text~     messages plus SMS support messages. The control group (n=20) will receive SMS support~     messages to aid in quitting.~   "
80693|NCT02510703|"~     Type 2 diabetes is associated with early and diffuse abnormalities of endothelial function,~     especially in the coronary arteries, which are a factor of poor prognosis. Following acute~     coronary syndrome, the endothelial function abnormalities usually persist for several weeks~     before regressing. Their persistence 6-8 weeks after myocardial infarction is a poor~     prognostic factor. Investigators assume that global abnormalities of endothelial function in~     patients with diabetes may be additive with segmental abnormalities in revascularized~     myocardium, and contribute to worsening the prognosis in these patients. Furthermore, there~     is no published data showing any relationship between calcium score and endothelial function~     abnormalities in these patients. The investigators seek a relationship between calcium score~     and persistence of abnormalities of coronary endothelial function in these patients.~      The main objective of this study was to compare coronary endothelial function by quantitative~     method (TEP at 15O-H2O) in diabetic patients and nondiabetic following acute coronary~     syndrome.~   "
80694|NCT02510690|"~     This study aims to analyse the results of national data collected by the e-Dengue Information~     System in order to determine the factors associated with disease outcomes in all patients~     registered from January 2013 to December 2014.~   "
80695|NCT02510677|"~     The prognosis of patients with heart failure has improved due to recent breakthrough in~     medical treatment and cardiac resynchronization devices. However, there is no paraclinical~     parameter to assess response to cardiac resynchronization therapy (CRT). This is a major~     issue since about a third of implanted patients will not be improved by CRT. CZT SPECT allows~     to perform myocardial perfusion imaging in less than 4 minutes and is able to study~     myocardial perfusion, viability, left ventricular function, but also ventricular asynchrony.~      Using low-dose dobutamine gated SPECT and CZT camera, we aimed to assess left ventricular~     dyssynchrony in viable segments in patients with heart failure eligible for CRT.~   "
80696|NCT02510664|"~     The purpose of this study is to determine whether a newly developed intervention is feasible~     and acceptable to adolescents with type 1 diabetes and their families and diabetes care~     providers, and to evaluate trends in whether the intervention impacts important diabetes~     outcomes. The intervention involves diabetes care providers discussing and reinforcing~     individuals' and families' diabetes management strengths during routine, outpatient diabetes~     care appointments.~   "
80697|NCT02510651|"~     ORSHFS grafts yielded lower cell counts than NCECS but the M-K ratio and resultant~     repigmentation did not show significant difference with better healing of the donor site.~     Compared to cryoblebs, CO2 gave more homogenous pigmentation. The acral sites showed better~     results using combination of donor NCECS and recipient cryoblebs.~   "
80698|NCT02510638|"~     Dengue infection has been identified as the fastest spreading mosquito-borne viral disease by~     World Health Organization (WHO), which affects more than 2.5 billion people living in the~     subtropical and tropical regions. Malaysia is hyper-endemic with all four dengue virus~     serotypes circulating and responsible for the escalating number of cases over the years. As~     of 28 February 2015, there are 62 deaths secondary to dengue infection being reported in~     Malaysia; and the total number of dengue cases reported in the same period was 23,966 which~     is 46% higher than the same reporting period of 2014. Although dengue virus has been~     identified for so many years and plenty of research work has been carried out, it was proven~     that there are still many aspects that we are not too sure about the disease. Therefore, this~     multi-center, observational cohort study is designed to investigate the clinical course of~     hospitalized dengue infection in Malaysia. The study population of this study consists of~     male or female patients with dengue to be randomly sampled from hospitals in Malaysia. This~     study will be conducted in 2 stages whereby the 1st stage will only focus on the basic social~     and clinical data to describe the clinical course of dengue as general and the 2nd stage will~     collect the more detailed clinical and management data to describe the detailed clinical~     course, management and prognosis of dengue. All hospital participation in this study is~     voluntary, and approval will be obtained from National Institute of Health (NIH) and Medical~     Research Ethics Committee (MREC) prior to any recruitment.~   "
80699|NCT02510625|"~     The objective of this study is to investigate arthroscopic treatments of recurrent anterior~     shoulder instability. Functional outcomes of arthroscopic anatomic glenoid reconstruction~     with bone graft will be compared to the gold standard, arthroscopic Bankart repair. The~     investigators hypothesize that arthroscopic anatomic glenoid reconstruction with bone graft~     will provide better functional outcomes and decreased risk of recurrent~     dislocation/subluxation.~      This will be a single center, double blinded, randomized controlled trial performed in~     Halifax, Nova Scotia, Canada. The primary outcome measured will be the Western Ontario~     Shoulder Instability (WOSI) score. Secondary outcomes will be subluxation, re-dislocation,~     and range of motion. A minimum of 200 patients will be enrolled in the study as determined by~     sample size calculation. Routine radiographs as well as a pre-operative CT with 3D~     reconstruction and MRI are obtained for all patients. The patients will then undergo a~     clinical examination and complete a variety of functional and quality of life surveys.~     Randomization will be based on surgeon skill. Two groups (Bankart repair and anatomic glenoid~     reconstruction) will be selected with 100 subjects each. Postoperatively, patients in both~     groups will follow a standardized rehabilitation protocol. The patient will follow-up with~     the attending surgeon at 2 weeks post-operatively for a wound check. At the 3, 6, 12, and 24~     month visits the patient will again undergo the structured clinical examination conducted by~     a physiotherapist who is blinded to the patients' treatment group. The patient will also~     complete the questionnaires at each of these follow-up appointments. Complications, and~     subluxation/dislocation events will be documented at each follow-up evaluation. On the basis~     of a clinical examination and patient history, the surgeon will diagnose recurrent~     instability and categorize it as a traumatic or atraumatic subluxation or dislocation.~   "
80700|NCT02510612|"~     Dexmedetomidine's Sedative Effect on Diabetic Patient~   "
80701|NCT02510599|"~     The purpose of this study is to evaluate the effects of solithromycin on hepatic histology~     and biomarkers in patients with nonalcoholic steatohepatitis.~   "
80702|NCT02510586|"~     The aim of the present study is to evaluate the effect of sevoflurane postconditioning on the~     incidence of postoperative hyperperfusion syndrome following revascularization surgery in~     moyamoya patients.~   "
80703|NCT02510573|"~     The current study was designed to investigate the change of serum ficolin-3 levels and assess~     the prognostic predictive effect of serum ficolin-3 levels in the patients with severe~     traumatic brain injury.~   "
80704|NCT02510560|"~     The study will evaluate the effect of NTRA-2112 on intestinal malabsorption in preterm~     infants.~   "
80705|NCT02510547|"~     CrossBoss First is a single-blind randomized controlled trial that will randomize 246~     patients undergoing clinically-indicated Chronic Total Occlusion Percutaneous Coronary~     Intervention, to upfront use of the CrossBoss catheter vs. antegrade guidewire escalation~     strategy The CrossBoss First study has two primary objectives. The primary efficacy~     objective is to compare the procedure time required to cross the CTO or abort the procedure~     with a CrossBoss first vs. antegrade wire escalation strategy. The investigators hypothesize~     that upfront use of the CrossBoss catheter will be associated with shorter procedure time~     required for CTO crossing compared with an antegrade wire escalation strategy.~      The primary safety objective is to compare the frequency of procedural major adverse~     cardiovascular events (MACE) with upfront use of CrossBoss vs. a guidewire escalation~     strategy. The investigators hypothesize that upfront use of the CrossBoss catheter will be~     associated with similar incidence of MACE compared with an antegrade wire escalation~     strategy.~      The secondary endpoints are: (1) technical and procedural success4-6; (2) total procedure~     time (defined as the interval between administration of local anesthesia for obtaining~     vascular access and removal of the last catheter); (3) fluoroscopy time to cross the CTO and~     total fluoroscopy time; (4) total air kerma radiation exposure; (5) total contrast volume;~     and (6) number of wires, microcatheters, balloons, and stents used.~   "
80706|NCT02510534|"~     To determine the difference in clinical pregnancy rates with and without luteal progesterone~     support in a young reproductive aged population having undergone ovulation induction with~     combined clomiphene citrate and gonadotropin protocol with intrauterine insemination.~   "
80707|NCT02510521|"~     Type 2 diabetes is a major public health problem because of its increasing prevalence and~     morbidity and mortality that accompanies it. Therapeutic management of this pathology,~     lifestyle measures, dietary and physical activity are fundamental. Their observance is~     unfortunately too often insufficient, leading to a therapeutic climbing with first oral~     antidiabetic (OAD) then the use of insulin therapy.~      Yet there is now ample evidence that physical activity improves glucose control in these~     patients in particular improving insulin sensitivity after a training period but also after a~     single session of physical activity.~      Neuro-myo-electrical stimulation (NMES) is used in common clinical practice in physical~     therapy, patients with neurological or after orthopedic surgery in particular. In fact, this~     method enables improvement of volume and strength, even for denervated muscles. Recent~     studies have also shown the benefits of NMES in situations of cardiac or respiratory~     readjustments. In addition, NMES is used by top athletes supplements classical training in~     order to develop muscle strength or speed recovery.~      Investigators propose to test the impact of bilateral quadriceps NMES on insulin sensitivity~     in type 2 diabetic patients treated with OAD (excluding glitazone). To do this, investigators~     plan to assess their insulin sensitivity by the reference method of hyperinsulinemic~     euglycemic clamp before surgery, after a single session of bilateral quadriceps NMES and~     after a sequence of daily training 6 days a quadriceps NMES bilateral.~      Investigators hope to show an improvement in insulin sensitivity by this method, which would~     constitute an alternative to physical activity in the treatment of diabetes type 2. This~     procedure would be particularly interesting in diabetic subjects with type 2 counter-~     indications or an inability to perform a conventional physical activity.~   "
80708|NCT02510508|"~     The aim of this study is to determine whether a group format Community Reinforcement and~     Family Training (CRAFT) and Self-Directed CRAFT Delivery are more effective than~     non-intervention in terms of Concerned Significant Others (CSO) well- being and cost-~     effectiveness.~   "
80709|NCT02510495|"~     The purpose of this study is to determine how different endoscopic papillary balloon~     dilatation (EPBD) duration time affects the complications after endoscopic retrograde~     cholangiopancreatography (ERCP) in the treatment of common bile duct stones.~   "
80710|NCT02510482|"~     Calcified aortic valve stenosis (CAVS) is a progressive disease and nowadays, the cornerstone~     in diagnostics and follow-up is echocardiography. Cardiac biomarkers (such as cardiac~     troponins T and I and NT-pro-BNP) hold promise to fulfil a role in early recognition of~     complications concerning the aortic valve and decompensation. For this purpose, it is~     important to assess the normal biological variation (BV) of cardiac biomarkers in CAVS. The~     assessment of biological variation will contribute to a better understanding of fluctuation~     of cardiac biomarkers in subjects with stable CAVS. These data will improve monitoring of~     CAVS using cardiac biomarkers.~   "
80711|NCT02510469|"~     The purpose of this study is to assess the efficacy and safety of apatinib as maintenance~     therapy after adjuvant chemotherapy in progressive gastric cancer patients with positive~     exfoliative cancer cells.~   "
80778|NCT02509598|"~     Open label, non-randomized, multi-center, within-subject comparative study to evaluate the~     tolerability and the diagnostic utility of Lymphoseek with optional comparison to VBD in~     pediatric subjects with melanoma, rhabdomyosarcoma, or other solid tumor. Subject age will~     range from neonatal through 17 years.~   "
98000|NCT02284490|"~     This phase II trial is studying how well pemetrexed disodium works in treating patients with~     Lung Adenocarcinoma With Brain Metastases~   "
80712|NCT02510456|"~     This study seeks to enroll women with breast cancer undergoing neoadjuvant chemotherapy to~     evaluate the efficacy of an investigational imaging technology known as Diffuse Optical~     Spectroscopy Imaging (DOSI) in predicting patient response to chemotherapy treatment. DOSI is~     a noninvasive imaging method that uses harmless near-infrared light using a simple handheld~     probe held against the skin to predict tumor metabolic activity. It uses nonionizing~     radiation, requires no external contrast agent and uses low light exposure to human tissue.~     DOSI scans can be performed frequently at the bedside in settings such as a doctor's office~     or infusion center.~   "
80713|NCT02510443|"~     Using a very broad survey, the objective is to confirm the effectiveness of the Essure~     method, and to obtain more information on the conditions of use as well as on the methods~     used during the 3-month check-up, as well as the 12-month, 24-month and 5-year follow-up on~     patients.~   "
80714|NCT02510430|"~     Excessive sitting time (sedentary time) has been associated with risk of insulin resistance~     and other factors which may be relevant to breast cancer prognosis. This 8-week study tests~     different strategies for helping breast cancer survivors to modify their levels of sitting~     time. Participants will be assigned with equal likelihood to one of three groups (1) overall~     reduction in sitting time, (2) interruption of sitting time with standing breaks, and (3)~     usual care.~   "
80715|NCT02510417|"~     The primary purpose of the study is to evaluate whether most closely HLA-matched~     multivirus-specific T cell lines obtained from a bank of allogeneic virus-specific T cell~     lines (VSTs) have antiviral activity against three viruses: EBV, CMV and adenovirus.~      Reconstitution of anti-viral immunity by donor-derived VSTs has shown promise in preventing~     and treating infections associated with CMV, EBV and adenovirus post-transplant. However, the~     time taken to prepare patient-specific products and lack of virus-specific memory T cells in~     cord blood and seronegative donors, limits their value.~      An alternative is to use banked partially HLA-matched allogeneic VSTs. A prior phase II study~     at our institution using trivirus-specific VSTs generated using monocytes and EBV-transformed~     B cells gene-modified with a clinical grade adenoviral vector expressing CMV-pp65 to activate~     and expand specific T cells showed the feasibility, safety and activity of this approach for~     the treatment of refractory CMV, EBV and Adenovirus infections. However, the production~     process was lengthy, requiring 8-12 weeks, with exposure to biohazards (B95.8 EBV viral~     strain and adenovector), while antigenic competition between different viral components~     precluded increasing the spectrum of specificity beyond these three viruses.~      Investigator have overcome these limitations and in the current trial, they will evaluate~     whether rapidly generated, allogeneic most closely HLA-matched multivirus-specific VSTs,~     activated using overlapping peptide libraries spanning immunogenic antigens from CMV,~     adenovirus and EBV will be safe and produce anti-viral effects in allogeneic HSCT recipients~     infected with one of more of the targeted viruses that are persistent despite conventional~     anti-viral therapy. The study agent will be assessed for safety (stopping rules defined) and~     antiviral activity.~   "
80716|NCT02510404|"~     PIDD represent an expanding group of genetic disorders that compromise immunity against~     bacteria, viruses, and fungi. The most severe forms of PIDD cause profound susceptibility to~     opportunistic infections due to impaired or absent T-cell immunity. These diseases can be~     rapidly fatal unless treated via hematopoietic stem cell transplantation (HSCT). Chronic~     viral illnesses are a common presenting feature of many of these disorders, and studies have~     shown that survival of HSCT is profoundly impacted by the patient's pre-transplant disease~     status. Primary infections with viruses such as cytomegalovirus (CMV) and Epstein-Barr virus~     (EBV) are common, and respiratory viruses such as adenovirus also frequently cause infection.~     In patients with severe combined immunodeficiency (SCID), a prior study identified these~     viruses as the most common causes of mortality in the immediate period following HSCT. Though~     some forms of PIDD are amenable to HSCT without requiring conditioning chemotherapy, many~     forms require a variable degree of pre-conditioning to ensure that stable engraftment of the~     donor cells is achieved. The administration of cytotoxic chemotherapy used in the~     conditioning regimens can however increase the risk for regimen related toxicity and for some~     patients (especially those with active viral infections) this risk is particularly high,~     leading to high treatment related mortality rates. For these reasons, many such patients are~     not even considered candidates for HSCT or are delayed getting to HSCT and ultimately succumb~     to infection before they can receive the transplant.~      The primary objective of this study is to determine the safety of administering third-party~     multivirus-specific cytotoxic T lymphocytes (mCTL) from adult CMV seropositive donors to~     treat refractory viral infections in patients with primary immunodeficiency disorders (PIDD)~     prior to hematopoietic stem cell transplantation (HSCT).~   "
80717|NCT02510391|"~     This nonrandomized pilot study is investigating the efficacy of a modularized treatment for~     anxiety in children ages 3-7 years old. Eligibility is determined at a baseline assessment,~     followed by a second baseline assessment one month later. The treatment protocol,~     Parent-training Intervention for Preschoolers with Anxiety (PIPA), is flexible and allows for~     individualized treatments based on a treatment algorithm, ensuring that sessions address the~     most pressing clinical needs of each child. Treatment consists of weekly 60-minute sessions~     delivered over the course of 12 weeks. Symptom change is tracked weekly during brief phone~     assessments and a post-treatment assessment will occur following the final treatment session,~     approximately 12 weeks after starting treatment. Finally, all participants will complete two~     follow-up assessments, occurring 1-month and 6-months after the final treatment session.~   "
80718|NCT02510378|"~     Patients with rectal cancer and resectable liver metastases receive short course~     radiotherapy(5Gy/f x 5f) to the pelvis and XELOX consolidating chemotherapy al least 4 cycles~     after 2 weeks.~   "
80719|NCT02510365|"~     The study is designed to assess the safety and efficacy of functional neural regeneration~     collagen scaffold transplanted into acute spinal cord injury patients.~   "
80720|NCT02510352|"~     In accordance with national guidelines surgical repair of rotator cuff tear is the first-line~     strategy only in young patients, depending on tear size, fatty infiltration of rotator cuff~     muscles and articular status. In appropriate situations, a satisfactory result is expected in~     more than 80% of cases with a very good long-term outcome. On the other hand, the first-line~     strategy in older patients is conservative as the main objective is the treatment of pain and~     stiffness of the shoulder which can be achieved at least in the short-term with general and~     local medications and physiotherapy. In addition, poor prognostic factors such as massive~     tears and muscle fatty infiltration or atrophy, are more frequently present in those~     patients, leading to poor results of surgical treatment and a high risk of iterative tear~     after repair.~      Because of a lack of evaluation, there is currently no identified prognostic factor of~     medical treatment and on the other hand no clinical situation in which a surgical repair is~     mandatory. Therefore, investigator designed this study as an observatory with the follow up~     of patients with a symptomatic rotator cuff tear treated conservatively.~   "
80721|NCT02510339|"~     The goal of this project is to determine the incidence of intra-articular knee pathology~     following tibial shaft fractures as evaluated by intraoperative knee aspiration and physical~     exam, and to evaluate for chondral injuries following treatment with a suprapatellar tibial~     nail via MRI.~   "
80779|NCT02509585|"~     Prospective, open-label, within-patient, multi-center study of Lymphoseek in the detection of~     lymph nodes in subjects with known cancer of the cervix. All subjects will receive a single~     dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m.~   "
80722|NCT02510326|"~     The scaphotrapeziotrapezoid (STT) joint is a dome shaped joint in the radial wrist that is~     important in transfer of load from the thumb and radial hand to the scaphoid and the~     radioscaphoid and scaphocapitate joints. Arthritis in this joint is the second most common~     degenerative arthritis in the wrist, reported in 15% of wrist radiographs. The true incidence~     of arthritis in the STT joint however is unknown though we assume that most cases of~     arthritis are not clinically significant. Furthermore, the clinical and biomechanical~     significance of arthritis in this joint is unclear. The investigators' clinical impression is~     that the incidence of STT joint arthritis is inversely related to that of radiocarpal joint~     arthritis. In an ongoing study, we are examining the relationship between STT joint arthritis~     and radiocarpal joint arthritis on radiographs.~      We suggest that STT joint arthritis alters the biomechanics of the wrist by limiting movement~     of the scaphoid within the STT joint thereby protecting the wrist from radiocarpal arthritis~     by limiting instability of the scaphoid.~      The specific aims of this pilot study are to evaluate the movement of the arthritic scaphoid~     within the STT joint using a computer-generated model based on CT scan of the wrist and to~     compare this model with the already established model of the normal STT joint.~      The investigators' hypothesis is that there is significantly less motion in the arthritic STT~     joint.~   "
80723|NCT02510313|"~     The proposed study will test the effectiveness of the Strong Families, Thriving Children~     Sugira Muryango program as delivered by community based workers and aligned with the~     Rwandan social protection system. Sugira Muryango is a preventive, family-based model that~     uses home visiting and coaching to encourage responsive parent-child interactions and~     discourage violence and harsh punishment targeting families living in extreme poverty.~     Integration of scalable, cost-effective interventions into poverty-reduction and other social~     welfare programs has great potential as an effective means to promote child development and~     reduce familial violence and in a range of culturally diverse, low-resource settings.~   "
80724|NCT02510300|"~     This Registry will enroll adolescent and pediatric participants who received at least one~     Gilead Hepatitis C Virus (HCV) direct acting antiviral (DAA) while participating in a~     Gilead-sponsored chronic hepatitis C clinical trial. The primary objective of this Registry~     is to determine the long-term safety of anti-HCV regimens in the pediatric population.~     Secondary objectives of this Registry are to determine whether subsequent detection of HCV~     RNA in participants who relapse following sustained virologic response (SVR) represents the~     re-emergence of pre-existing virus, the development of resistance mutations, or whether it is~     due to re-infection, and to characterize resistance mutations and the persistence of~     resistance mutations in pediatric participants who did not achieve SVR. Once enrolled,~     participants will be followed for up to 5 years.~   "
80725|NCT02510287|"~     The analgesic approach in labor can be done in different ways, among which the neuraxial~     approach has shown the best analgesic results and fetal outcomes. Currently, programmed~     epidural intermittent bolus has been included in the neuraxial approach for a better~     distribution of the solution into the epidural space as compared with the continuous infusion~     strategy. In this study, the investigators seek to compare both strategies in 132 laboring~     women.~   "
80726|NCT02510274|"~     The objective of this study is to assess PK, safety and tolerability of a single oral dose of~     ASP3325 and to assess PD, PK and safety of repeated oral doses of ASP3325 administered t.i.d.~     before or just after each meal~   "
80727|NCT02510261|"~     The purpose of this study is to evaluate the safety and efficacy of long-term dosing with~     ALN-TTR02 (patisiran) in patients with transthyretin (TTR) mediated amyloidosis (ATTR).~   "
80728|NCT02510248|"~     This is a Phase 1, randomized, double-blind, placebo-controlled, first-in-human, 3-part study~     in which the safety, tolerability, and pharmacokinetics of orally administered AL-704 will be~     assessed in healthy adult subjects and in adult subjects with CHC infection.~      Part 1: Healthy adult subjects will receive one of 5 single ascending oral doses (SAD) of~     AL-704 ranging from 100 mg to 1,500 mg (Cohorts 1 to 5). Within each cohort subjects will be~     randomized to receive either AL-704 or placebo (n=8 per cohort; 6 assigned to AL-704 and 2~     assigned to placebo), in a fasted state.~      The planned dose-escalation scheme may be changed based on the emerging PK and safety data.~     Two additional cohorts (Cohorts 6 and 7) may be enrolled for evaluation of additional doses~     at the discretion of the Sponsor and Investigator, based on the emerging pharmacokinetic (PK)~     profile, and the presence of an acceptable safety profile.~      Part 2: To assess the food effect on pharmacokinetics, 8 healthy subjects from one full Part~     1 cohort who received a single dose of AL-704 or placebo in a fasted state, will receive the~     same single dose of AL-704 or placebo in a fed state in Part 2 after a washout period of 7-14~     days (depending on PK results). It is expected that Cohort 3 of Part 1 (600 mg dose) will be~     selected, however this depends on the evaluation of available PK and safety data from Part 1~     of the study.~      Part 3: The following cohorts of 10 adult subjects each, with CHC infection, will be~     evaluated. Subjects with CHC genotype 1 infection (Cohorts 8 to 10) and subjects with CHC~     genotype 3 infection (Cohort 11) will be randomized to receive AL-704 or placebo for 7~     consecutive days (n=10 per cohort, 8 assigned to AL-704 and 2 assigned to placebo) in a fed~     state. The treatment is anticipated to be administered in a once daily dose regimen or a~     twice daily dose regimen. The dose and dose regimen to be administered will be determined by~     the Sponsor depending on the PK and safety outcomes of previous cohorts.~   "
80729|NCT02510235|"~     Dry eye is a multifactorial disease of the tears and ocular surface that results in symptoms~     of discomfort, visual disturbance, and tear film instability with potential damage to the~     ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation~     of the ocular surface.~      Lubricin is a mucin-like glycoprotein originally discovered in synovial fluid, as a secreted~     product of cells that line the joint tissues, which is present at the surface of articular~     cartilage and it has been investigated on its roles at the ocular surface, in normal and~     pathologic conditions such as dry eye.~      The objective of the study is to assess the tolerability, safety and efficacy of Lubricin eye~     drops solution administered over 4 weeks versus sodium hyaluronate (Na-HY) eye drops solution~     in subjects with moderate dry eye.~   "
80730|NCT02510222|"~     This study is considered a pilot exploratory study. Intervention, prospective, double-armed,~     randomized, placebo-control clinical trial.~      The therapeutic effect of oral Magnesium sulfate on spasticity and constipation will be~     studied.~   "
80731|NCT02510209|"~     This study tested the extent to which TOP®, when replicated with fidelity, produced impacts~     on sexual risk-taking behaviors in the short term and the longer term.~   "
80775|NCT02509637|"~     Bronchiectasis is characterized pathologically by the abnormal and permanent dilation of~     bronchi caused mainly by the perpetuation of inflammation and impaired clearance of~     secretions. Physical therapy is essential in the treatment of these patients, using its~     various techniques and devices. The aim of this study is to evaluate the impedance of the~     respiratory system, by impulse oscillometry, after breathing exercises with chest compression~     or flutter in patients with bronchiectasis, considering that there are no results in the~     literature on the effect of these techniques in the small airways of these patients.~   "
80732|NCT02510196|"~     Teaching program population: Participants in Hadassah Ein Kerem ultrasound training day -~     Anesthesia residents Exclusion criteria: Refusal to participate, insufficient understanding~     of written English used in the questionnaires~      Stage 1 - training The aims and requirements of the teaching program will be explained to the~     participants at the start of the workshop. All participants will be given a sticker with a~     number and a questionnaire numbered about current ultrasound practice which is numbered~     according to participant number to allow for blinding. Anyone not wishing to participate can~     either remove their sticker or not return the questionnaire at the end of the session. The~     number on the questionnaire correlated to participant number. This will be recorded against~     the participant name to allow for further follow up. All participants will rotate normally~     throughout the sessions. At the end of the neuraxial session participants will be scored by~     the session leader according to their ability to adequately carry out the procedure. Scores~     will be correlated to participant number.~      Stage 2 - assessment of skill retention~      Following the training day participants will randomly be allocated into two groups. One group~     will receive regular reminders to use ultrasound for all neuraxial anesthesias they perform~     in the OR or labor ward. They will be reminded on a regular basis that ultrasound is a new~     tool to assist them in performing neuraxial ultrasound. The other group with be allowed to~     continue with their regular practice and will not receive reminders to use ultrasound for~     neuraxial anesthesia insertion. Two months after the initial training day all participants~     with be observed performing neuraxial anesthesia and re-assesed according to the original~     scoring system. Each participant will be assessed 3 times over a 6 month period.~   "
80733|NCT02510183|"~     This study is to evaluate the effect of preoperative acupressure application on Postoperative~     nausea and vomiting (PONV) in patients undergoing laparoscopic cholecystectomy in terms of~     being in high risk group for PONV.~   "
80734|NCT02510170|"~     In this study, measurements of fetal and maternal head circumference will be collected. This~     data will be presented in table or graph form. The effect of maternal head circumference on~     fetal head circumference will be evaluated and presented in either formula or graph form.~   "
80735|NCT02510157|"~     This study aims to investigate the possible clinical effect of dexamethasone on the action of~     sugammadex when it is administered to reverse deep neuromuscular blockade caused by~     rocuronium in laparoscopic cholecystectomies.~   "
80736|NCT02510144|"~     Propionibacterium acnes is the most common pathogen identified from a surgical site infection~     in the shoulder. Standard skin preps do not prevent this type of infection. Patients will~     undergo either a chlorhexidine or benzoyl peroxide prep in days leading up to surgery.~     Bacterial burden will be determined at the time of surgery.~   "
80737|NCT02510131|"~     To determine whether Hyacinth exercises are more effective than Kegel's exercise at improving~     pelvic floor weakness among women aged 55 and above with urinary incontinence.~   "
80738|NCT02510118|"~     The aim of this study is to evaluate the synergistic anti-tumor effect of ChangTai Keli based~     on chemotherapy for colon cancer patients by a randomized, parallel-group, double-blind,~     multicenter clinical study.~   "
80739|NCT02510105|"~     The study is intended to elucidate the pulmonary effects of Intrapulmonary Percussive~     Ventilation (IPV) with VDR4 ventilator of patients with ARDS, using computed tomography (CT).~   "
80740|NCT02510092|"~     This study evaluates in vivo intracoronary imaging using intravascular ultrasound and optical~     coherence tomography and safety and efficacy of new generation fully bioresorbable vascular~     scaffolds in four well defined systemic autoimmune (rheumatoid arthritis, mixed connective~     tissue disease, systemic sclerosis, systemic lupus erythematosus) and concomitant coronary~     disease patients.~   "
80741|NCT02510079|"~     The primary purpose of this research study is to determine the safety of injecting ones own~     Schwann cells to augment sural nerve autografts after a severe, non-lacerating injury to the~     sciatic nerve has occurred.~   "
80742|NCT02510066|"~     This study compares the effect of acupuncture and placebo acupuncture on advanced pancreatic~     cancer pain and then investigates its potential mechanism of peripheral blood.~   "
80743|NCT02510053|"~     To investigate pharmacokinetics(PK) and pharmacodynamics(PD) of Caspofungin in ICU patients~     after received a loading dose of 70mg followed by 50mg (35mg if Child-Pugh score is 7-9), 40~     patients will be recruited. Blood samplings for PK analysis will be collected on day 4 in~     this study. Caspofungin plasma concentrations are measured by using solid phase extraction~     and reverse phase high-performance liquid chromatography. Safety analyses will be taken daily~     during the treatment of Caspofungin. Tests for drug tolerance of fungi and efficacy~     assessment (clinical and mycological responses) will be taken every 3 days by clinical and~     mycological tests.~   "
80744|NCT02510040|"~     The purpose of this study is to describe clinical characteristics, treatments, and one-year~     outcomes of adults with convergence insufficiency, divergence insufficiency, or small angle~     hypertropia.~   "
80745|NCT02510027|"~     While there is broad consensus that HR-HPV detection is the best available primary screening~     test, there is no agreement about the most efficient and reliable triage procedure for HR-HPV~     positive women. Transient HR-HPV infections are very common, and the vast majority of these~     infections spontaneously regress after a year or two. Only a small fraction of cases will~     lead to persistent infection responsible for cervical neoplasia. The FRIDA Study is a large,~     population-based study that was designed to evaluate the performance and cost-effectiveness~     of different triage strategies for hrHPV-positive women in Mexico.~   "
80746|NCT02510014|"~     A multi-center, open-label, long-term safety study in which approximately 600 subjects~     diagnosed with opioid use disorder will be enrolled. Following a screening period, all~     subjects will receive run in SUBOXONE sublingual film followed by an initial injection of~     open-label high dose (300 mg) RBP-6000. The RBP-6000 monthly injection dose can be adjusted~     to low dose (100 mg), and back to high dose, based on the medical judgment of the~     Investigator. Subjects will participate in the study for either 6 or 12 months.~   "
80747|NCT02510001|"~     This trial is designed to try two new cancer drugs together for the first time. The~     investigators think that they might be effective in some types of bowel cancer. The first~     part of the trial will see what doses of the two drugs can safely be given together. Once the~     investigators have identified a suitable dose combination they will look at how effective~     treatment is in bowel cancers where either the RAS gene is mutated, or MET is over-active. In~     the trial the investigators will look at samples of blood, skin and tumour to check the drugs~     are working in the way expected. The trial will take place in three sites in the UK and 5~     sites in Europe. The trial is funded as part of the European commission's FP7 program.~   "
80748|NCT02509988|"~     The study aims to assess whether a nutritional drink taken before conception and continuing~     through pregnancy, assists in the maintenance of healthy glucose metabolism in the mother and~     promotes offspring health.~   "
80749|NCT02509975|"~     This is a prospective, pilot, open-label, uncontrolled, non-randomized safety and~     effectiveness study of OCL 503 in men with BPH.~   "
80751|NCT02509949|"~     Delirium, an acute change in mental status, is a serious medical complication among~     hospitalized patients. Syndrome of delirium involves agitation, sleep disturbance, affective~     disorders and cognitive disruptions.~      One vulnerable period for developing delirium is in the postoperative days. Postoperative~     delirium often initiates a cascade of adverse consequences including an increase in length of~     stay and hospital costs, and greater mortality. The investigators have observed that the~     incidence of postoperative delirium in patients after renal transplantation is about 20-30%~     in our hospital.~      Several studies have revealed that dexmedetomidine, as a widely used sedative during~     anesthesia, can decrease the incidence of postoperative delirium after cardiac surgery. The~     investigators aim to examine whether administration of dexmedetomidine can reduce~     postoperative delirium after living donor renal transplantation in adult patients.~   "
80752|NCT02509936|"~     This study seeks to evaluate the impact of an intensive home-based education intervention~     targeting severely stunted Guatemalan children for catch up growth and improved development.~     Half of the children in the study will receive standard of care, which includes micronutrient~     supplementation and a food ration. The other half of children in the study will receive, in~     addition to the above, home-based dietary assessment and individualized parental nutrition~     education.~   "
80753|NCT02509923|"~     The purpose of this study is to evaluate pharmacokinetics and pharmacodynamics of Z-215 (10~     mg, 20 mg, 40 mg) , compared with Rabeprazole Sodium (10 mg, 20 mg ) in Healthy Male~     Subjects. And to evaluate food-effect in Healthy Male Subjects administrated Z-215 20 mg.~   "
80754|NCT02509910|"~     This study examines the effect of an algorithm for GDT for patients undergoing major surgery~     under routine conditions.~   "
80755|NCT02509897|"~     To study the effects of normobaric hypoxic training on cardiorespiratory fitness, resting,~     postprandial and exercise activity energy expenditure, immunoregulatory functions and serum~     erythropoietin levels in relapsing-remitting multiple sclerosis patients.~   "
80756|NCT02509884|"~     Comprehensive diagnosis and treatment of Alveolar Echinococcosis : A single-center, long-term~     observational study of 312 Patients in Germany. Human alveolar echinococcosis (AE) is the~     most Iethal human helminthic infection and is one of the 17 neglected tropical diseases~     prioritized by the World Health Organization (WHO). Its incidence is low in endemic regions~     of Central and Western Europe (0.03-0.05/100,000), but morbidity and treatment costs are~     high. In this observational study, the investigators assessed the severity of the disease~     using the PNM staging system and report on the long-term results of specific AE therapy in an~     interdisciplinary team of clinicians.~   "
80757|NCT02509871|"~     This cross-sectional study of pathophysiology will bring additional informations on body~     composition of patients treated by adjuvant hormonal therapy for breast cancer. This is a~     complementary study of Metaca study (AU882).~   "
80758|NCT02509858|"~     We investigated the effect of the administration of small doses of thyroxine to healthy~     humans and patients with type 2 diabetes on postprandial forearm muscle glucose uptake,~     insulin sensitivity indices, lipid metabolism, in vitro glucose uptake and GLUT4 recruitment~     in the plasma membrane of monocytes.~   "
80759|NCT02509845|"~     The purpose of the clinical study is to evaluate the safety and bacterial impact of study~     drug (C16G2) administered in multiple oral gel doses to adolescent and adult dental subjects.~   "
80760|NCT02509832|"~     COOL AMI EU Pilot Trial: A Multicenter, Prospective, Randomized Controlled Trial to Assess~     Cooling as an adjunctive Therapy to Percutaneous Intervention in Patients with Acute~     Myocardial Infarction.~      Evaluate the retention of subjects after integrating therapeutic hypothermia using the ZOLL~     Proteus IVTM System into existing STEMI treatment protocols for subjects who present with~     acute anterior myocardial infarction.~   "
80761|NCT02509819|"~     The Intrepid Dynamic Exoskeletal Orthosis (IDEO) is a type of ankle foot orthosis designed to~     reduce pain and improve function for individuals with foot/ankle pain and/or weakness.~     Because the IDEO restricts ankle movement, the geometry and mechanics of the device must be~     designed to allow for a smooth roll-over as the patient walks with the IDEO. The heel wedge,~     while not physically part of the IDEO, is an integral part of the IDEO-heel wedge-shoe~     system. The goal of this research is to determine how heel wedge properties may contribute~     to the smoothness of roll-over during gait. Insight into the effects of heel wedge properties~     on roll-over will help optimize the design of the IDEO-heel wedge-shoe system and may~     produce guidelines for the customization of these features.~   "
80762|NCT02509806|"~     The purpose of this study is to assess the efficacy and safety of apatinib as maintenance~     therapy after first-line chemotherapy in Postoperative Recurrence / Metastasis Progressive~     Gastric Cancer.~   "
80763|NCT02509793|"~     The purpose of this research study is to see if tetrabenazine, which is commonly used to~     treat Huntington's Disease (HD), reduces the problems of impulsivity that are common in~     patients with HD. Investigators will also see how the medicine affects aspects of thinking~     and mood.~   "
80764|NCT02509780|"~     Vichy water is a type of spring water which traditionally comes from the famous spa town of~     Vichy, France. The springs which feed Vichy carry a high amount of dissolved minerals.~     Alkaline salts such as sodium bicarbonate are a primary ingredient in Vichy water, along with~     calcium and magnesium carbonates.~      Bicarbonates alkalinize urine, which is fundamental in preventing and/or diluting uric acid~     crystals. These are the main component of the uric acid stones or even oxalate stones, which~     generally  use  a crystal of uric acid as nucleus for stone formation. Cystine stones can~     also be treated by alkalinizing urine.~      Any disorder leading to a low urinary pH ( < 5.5 ) may predispose to stone formation. In this~     context , the solution of uric acid and the prevention and treatment of uric acid stones can~     be obtained by alkalization of the urine . The ideal alkalization is achieved when a urinary~     pH of 6-6.5 can be reached.~      The aim of this study is to evaluate the quantity of daily intake of the Vichy water~     necessary to obtain this alkalization of the urine. There are no data available in the~     literature about the relationship between the absolute quantity of Vichy water taken and the~     urinary pH ; nor about the possible influence of the Body Mass Index on this relationship.~   "
80776|NCT02509624|"~     This study will evaluate the pharmacokinetics (PK), safety, and tolerability of GS-4997 in~     adults with impaired hepatic function relative to matched, healthy controls. Each participant~     in the control group will be matched to a participant with impaired hepatic function by age~     (± 10 years), gender, and body mass index (± 20%).~   "
80765|NCT02509767|"~     This randomized clinical trial will study subcutaneous depot medroxyprogesterone acetate~     (DMPA sc) self-administration at two Planned Parenthood affiliates serving diverse patient~     populations. Prior studies demonstrate that DMPA self-injection is safe, effective, feasible,~     and acceptable for women and adolescents. A total of 400 female patients (ages 15-44)~     requesting DMPA will be randomized to self-administration of DMPA sc or clinic administration~     (usual care). Subjects will be followed for one year. The primary study outcome is DMPA~     continuation at one year by self-report in both study arms. Secondary outcomes include~     patient-reported satisfaction with treatment; satisfaction with home use; and costs~     associated with contraceptive care. The investigators hypothesize higher continuation rates~     among self-injection users compared to patients who receive standard care. Secondary~     exploratory hypotheses include higher patient satisfaction and lower costs associated with~     contraceptive care among self-injection users.~   "
80766|NCT02509754|"~     Atrial fibrillation (AF) and congestive heart failure (CHF) are two epidemics that share~     several physiopathological links. CHF patients present a significantly increased risk of~     developing AF and the related detrimental hemodynamic effects are even more relevant than in~     patients without CHF.~      Within CHF patients rate control is the most widely used strategy to manage AF, having proved~     non-inferior to rhythm control strategies. However, by this strategy, the hemodynamic effects~     of AF persist, not contrasting the natural evolution towards progressive left ventricular~     (LV) function, cardiac output , and symptoms worsening. Rhythm control strategy, instead, has~     shown, in the general population, advantages over rate control concerning survival, quality~     of life and thromboembolic events. The main limitation is that antiarrhythmic therapy used to~     achieve this goal has several side effects, and that transcatheter AF ablation has been~     assessed only in modest sample size studies.~      Available literature focusing on a direct comparison between two specific management~     strategies in patients with CHF and AF is limited to a small randomized study comparing~     pulmonary veins isolation to AV node ablation and biventricular PM implantation (PABA-CHF~     study). Additional indirect evidences may derive from meta-analyses of observational studies.~      The investigators therefore designed this multicenter, randomized controlled trial aiming to~     assess if, in recently diagnosed (less than 6 months) and optimally treated CHF patients with~     impaired LV function, AF catheter ablation is effective in improving LV function and clinical~     functional class, potentially driving to a reduction of device implantations (ICD/CRTs).~   "
80767|NCT02509741|"~     This research is aimed at verifying the effects of diets with high protein and low glycemic~     index (GI) on weight management among overweight or obese Chinese adult. Additionally, the~     investigators intend to verify the effects of two new approaches, including food replacement~     and Internet-of-things (IOT) monitoring on weight control.~   "
80768|NCT02509728|"~     To explore the effects of enteral choline and DHA supplementation on plasma choline and~     DHA-PC concentrations and metabolism, this randomized controlled study will assign 40 preterm~     infants to 1 of 4 groups: standard care, choline supplementation, DHA supplementation, and~     choline and DHA supplementation.~      After 7 days of supplementation, a single dose of stable isotope labelled choline will be~     administered and the kinetics of newly synthesized DHA-PC determined to assess plasma levels,~     uptake and distribution of choline and DHA.~      This study is designed to inform larger studies evaluating this approach of enteral~     co-application of choline and DHA on clinical important outcomes.~   "
80769|NCT02509715|"~     Effect of intraoperative nerve monitoring on voice quality during thyroid surgery~      Thyroidectomy is a quite often surgical procedure applied by both head and neck surgeons and~     endocrine surgeons.Recent advances in surgical and technological area achieve a remarkable~     decrease in the complication rates. In case of these advances, patients still have fear~     related with their voice. In this study, investigators aimed to investigate voice changes~     during thyroid surgery and effect of intraoperative nerve monitoring to the voice quality.~   "
80770|NCT02509702|"~     This study evaluates the effect of the SMS intervention 'Connected2Care' on the attendance~     rate to cervical cancer screening follow-up appointments.~   "
80771|NCT02509689|"~     A new technology called Global Z-Score Neurofeedback Technology (GZNT) has been identified~     that can overcome an existing barrier to the use of neurofeedback as a treatment technique in~     a military setting. Neurofeedback, or EEG Biofeedback, is a form of biofeedback that uses the~     brain's own electrical activity as the training parameter. With sufficient practice, the~     brain can learn to change its own activity through finely tuned feedback using computerized~     sounds, graphs and animations. Previous attempts at using neurofeedback as a treatment~     modality have been subject to a lack of standardization and have required significant~     expertise on the part of the provider. This new GZNT technology allows neurofeedback to be~     administered in a standardized and semi-automated fashion, which, if effective, will~     represent a significant advance toward providing this promising treatment modality to Service~     Members in a military or VA setting. This study will determine feasibility and preliminary~     evidence of efficacy for this neurofeedback technology in a pilot study of soldiers with~     medical issues associated with Traumatic Brain Injury (TBI). GZNT technology has the~     potential to provide a cost-efficient, non-invasive/non-pharmacological approach to recovery~     from impact and/or blast-induced brain injury, and holds promise to simultaneously address~     emotional symptoms that are often a part of the post-concussion symptom picture.~   "
80772|NCT02509676|"~     The purpose of this study is to investigate the effects of a 5-week dynamic stretching~     exercise training on muscle-tendon unit of gastrocnemius muscle.~   "
80773|NCT02509663|"~     The sinuplasty balloon offers a more physiological first of the sinuses which minimizes risks~     associated to traditional surgery. Its atraumatic characteristic also helps to reduce the~     risk of bleeding (so any use of Pack), limit scarring ransom, reduce the post-operative pain,~     ensure faster return to daily life activities (reduction of the average length of~     hospitalization). Patient's quality of life would be improved (SNOT-22 questionnaire) and~     reduction of post-operative pain score seams decrease on EVA.~      The economic impact of the sinuplasty balloon appears very favourable and fits into the~     strategy of development of the ambulatory practice.~   "
80774|NCT02509650|"~     The primary purpose of the protocol is to use next generation sequencing to identify~     pathogenic variants in genes involved in very rare skin diseases.~      The secondary purpose will be to study the genotype-phenotype correlation in order to~     re-evaluate the classification of these disorders. This work could help in the understanding~     of the physiopathology of very rare skin disorders.~   "
80780|NCT02509572|"~     The goal of this trial is to test a novel means of collecting patient-entered sexual health~     information for the provision of clinical decision support to increase the testing and~     detection of sexually transmitted infections (STI) in adolescent emergency department (ED)~     patients at high risk for STIs.~   "
80781|NCT02509559|"~     The main objective of the present study is to combine two lines of research, investigating~     the interaction between emotional processing and memory performance (on both behavioral and~     electrophysiological levels) and its modulation by ß-blockade.~      Concerning pharmacological manipulations with ß-blockers, there are no studies, which~     investigated the effects of propranolol on electrophysiological (ERPs) and behavioral~     measures of recognition memory along with their codependence on individual variations of~     adrenergic receptors' polymorphisms. Till now, also the findings about genetic influences of~     ADRB1 and ADRB2 on recognition memory for emotional contents are lacking.~      Therefore, the current investigation has been designed to replicate the former results which~     revealed reduced ERP correlates of recognition memory for emotional pictures due to~     administration of ß-blocker propranolol. Furthermore investigators goal is to test, whether~     there are any differences between carriers of genetic variants of the ADRB1 and ADRB2 in~     memory performance and/or changes in event-related potentials and in propranolol influences~     on the above mentioned processes.~      In conclusion, investigators hypothesize: (1) a memory advantage of emotionally arousing~     stimuli over emotionally neutral pictures; (2) more pronounced ERP components (EPN, LPP,~     old-new effect) associated with encoding and memory for emotional stimuli; (3) a reduction of~     electrocortical correlates of emotional recognition memory (old-new effect) caused by~     propranolol; (4) a potential impact of genetic variants of the ADRB1 and ADRB2 on the~     emotional information processing and memory formation alone, and on the propranolol~     modulation of those processes.~      Furthermore, investigators hypothesize additional pharmacodynamic effects of propranolol such~     as influence on skin- conductance, pulse waves, burdening heart frequency, pulmonary function~     and metabolomics, which might depend on the ADRB1 and ADRB2 genotype.~   "
80782|NCT02509546|"~     This phase I/II trial studies the side effects and best dose of 8-chloro-adenosine and how~     well it works in treating patients with acute myeloid leukemia that has returned after a~     period of improvement (relapsed) or has not responded to previous treatment (refractory).~     Drugs used in chemotherapy, such as 8-chloro-adenosine, work in different ways to stop the~     growth of cancer cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading.~   "
80783|NCT02509533|"~     To evaluate the VAC (Vacuum Assisted Closure) therapy in transplants of leg ulcers versus~     usual dressing method. The VAC Therapy system consists of:~        -  A unit delivering a precise under atmospheric pressure, controlled and regulated in the~          wound site,~        -  Consumables necessary for the implementation of the dressing,~        -  Collecting tanks exudates with gel. VAC therapy is a system using negative pressure. It~          is known to be efficient into care of chronic wounds and ulcerous wounds by increasing~          the cicatrisation.~      This system is systematically used into the dermatology unit of the CHU of Saint-Etienne~     after transplants of leg ulcers, but no data confirms the interest of this method compared to~     usual dressing method. This study will provide this data.~   "
80784|NCT02509520|"~     Elderly patients who experience a prolonged ICU stay are at high risk for developing post~     intensive care unit syndrome (PICS), a serious medical condition manifested by loss of muscle~     mass, weakness, malnutrition and neurocognitive decline. PICS often leads to chronic~     disability, prolonged mechanical ventilation and the need for costly extended stays in long~     term care facilities (LTCs). The investigators' preliminary study shows attempts at~     rehabilitating patients who have already developed PICS are minimally effective, resulting in~     only modest improvements in functionality. This project will determine the effects of~     mobility-based physical rehabilitation (MPR) combined with neuromuscular electric stimulation~     (NMES) and high protein supplementation (HPRO) early in a patients ICU stay on preventing~     PICS related musculoskeletal and functional deficits, and improving clinical outcomes.~   "
80785|NCT02509507|"~     This is a phase 1b/2, multicenter, open-label trial to evaluate the safety of talimogene~     laherparepvec injected intrahepatically into liver tumors with known progression alone and in~     combination with systemic IV administration of pembrolizumab, in subjects with non-HCC liver~     metastases from BC, CRC, GEC, melanoma, NSCLC, RCC, and subjects with HCC. The study consists~     of 2 parts and 2 groups, and Part 2 includes 2 stages. The objective of Part 1 is to evaluate~     the safety of intrahepatic injection of talimogene laherparepvec into liver tumors alone and~     in combination with systemically administered pembrolizumab for the non-HCC (Group A) and HCC~     (Group B) cohorts separately. Part 2 consists of 2-stage design to evaluate the efficacy and~     safety of talimogene laherparepvec in combination with systemic pembrolizumab. Efficacy and~     safety will be evaluated in each of the six non-HCC tumor types from Group A separately.~     Similarly, the efficacy and safety of the combination treatment will be determined for Group~     B HCC subjects.~   "
80786|NCT02509494|"~     The purpose of this study is the evaluation of the safety and immunogenicity of two candidate~     Ebola vaccines Ad26.ZEBOV and MVA-BN-Filo, in a heterologous prime-boost regimen.~   "
80787|NCT02509481|"~     The purpose of this study is to determine whether repeated ivermectin mass drug~     administrations to Burkinabé villagers, performed in three week intervals over the~     rainy-season, is well-tolerated and safe, and also effective in reducing local malaria~     transmission and thus clinical malaria episodes in treated village children.~   "
80788|NCT02509468|"~     The most recent classification, adopted by International Society for the Study of Vascular~     Anomalies (ISSVA) in 1996, and updated in Melbourne in 2014, divides these lesions into two~     broad categories: vascular tumors and vascular malformations. Vascular malformations (VMs)~     are subdivided into high-flow VM and slow-flow VM.~      Slow-flow VMs consist of congenital anomalies which may involve abnormal capillaries vessels,~     venous vessels, lymphatic vessels or combination of several of them. They can be superficial~     (involving cutaneous and subcutaneous tissues) and/or may have visceral involvement. They can~     be limited or diffuse, and are sometimes components of genetic hypertrophic syndromes.~      The diagnosis of slow-flow VMs is performed on physical examination (biopsy may be required~     for confirmation), and is completed with imaging (ultrasonography and magnetic resonance~     imaging (MRI)). Slow-flow VMs may be particularly voluminous; associated with underlying~     hypertrophy responsible for functional impairment; painful; associated with seepage or~     continuous cutaneous bleeding; complicated with visceral signs or hematologic disturbances~     (anemia, thrombopenia). Management requires dedicated multispecialty care. There are no~     guidelines for treatment, and management may include no intervention - but natural history of~     these VMs is progressive worsening -, compression by physical bandage, sclerotherapy,~     resection (when feasible),anti-inflammatory or anti-coagulation drugs.~      Case reports and series have provided evidence for supporting the need for a clinical trial~     of sirolimus by reporting successful treatment on several children with complicated vascular~     anomalies. The choice of sirolimus is rational. Mammalian target of rapamycin (mTOR) is a~     serine/threonine kinase regulated by phosphoinositide-3-kinase involved in cell mobility,~     cell growth and angiogenesis. Sirolimus inhibits mTOR, which induces inhibition of~     angiogenesis, in particular lymphangiogenesis, which has been demonstrated in several models.~   "
80789|NCT02509455|"~     To investigate whether an extended version of Valedo®Motion (termed Sensoro for brand~     management purposes), has the same trunk sway measures similar normal reference values of~     SwayStar. Offline data analysis of data obtained from Sensoro will be compared to data~     obtained by SwayStar, a highly accurate and widely accepted system for measuring balance~     control.~   "
80790|NCT02509442|"~     This study is about an experimental biomedical monocentric search concerning twelves patients~     presenting a infiltrative glioma of low rank OMS type II and realizing a surgery awakened on~     the site of the CHU of Montpellier.~      The objective of this search is to understand exactly how the electric impulses, delivered by~     the neurosurgeon to make a functional mapping of the brain during the surgery awakened by~     tumors infiltrates of low rank, propagate in this one and to identify the nervous networks~     inhibited by these electric impulses.~      Having verified the eligibility of the patients and having obtained their consent, they will~     be included in the study. Before the beginning of the surgery, the electroencephalography~     activity of the brain of every patient will be recorded. Before and after the surgical~     resection, the electrocorticography activity will be recorded.~      The collected data will then be analyzed, after the operation. Analyses will try to identify~     what we call potential evoked by the stimulation and which are small electric waves which~     appear after the electric stimulation was delivered.~   "
80791|NCT02509429|"~     The objective of this study is to assess the efficacy of an Artificial Pancreas system which~     includes a Control-To-Range algorithm, versus standard Insulin Pump Therapy with Threshold~     Low glucose Suspend feature. 24 Children aged from 7 to 12 will be recruted in 4 clinical~     centres. After a 2 week run-in period, they will attend two investigational sessions of 65~     hours in home-like settings. During each session, the CTR algorithm or the TLGS feature will~     be activated, depending on the randomization. The main endpoint is the time spent below~     70mg/dL between 22:00 and 07:00.~   "
80792|NCT02509416|"~     The establishment of a number of training programs in therapeutic endoscopy, standardization~     of the performance of endoscopic ultrasound (EUS) and endoscopy retrograde~     cholangiopancreatography (ERCP) and definition of competence is of paramount importance. The~     length of training and minimum number of procedures, requisite theoretical learning and~     methodology to define competence in EUS and ERCP are not well defined. The investigators~     research has demonstrated that individuals in training acquire skills at different rates and~     the number of procedures completed alone is a suboptimal marker for competency in a given~     procedure. Hence, emphasis needs to be shifted away from the number of procedures performed~     to performance metrics with well-defined and validated thresholds of performance. Multicenter~     prospective data are needed to help guide development of competency based medical education~     that define learning curves in EUS and ERCP and set evidence-based benchmarks required to~     achieve competence using a validated competency assessment tool.~      Hypothesis: The central hypothesis is that a validated EUS and ERCP competency assessment~     tool will allow for reliable and generalizable standardized learning curves, competency~     benchmarks and creation of a centralized national database that compares a trainee's~     performance amongst peers.~   "
80793|NCT02509403|"~     The purpose of this study is to assess the safety (absence of skin irritation) of a feminine~     hygiene product for perineal hygiene prior to undertaking a clinical effectiveness trial. The~     feminine hygiene towel or wipe is an anti-bacterial Natural Health Product solution.~   "
80794|NCT02509390|"~     Assessment of the evolution of fibrinogen plasma level within the first ten days after major~     trauma in order to determine prevalence of hyperfibrinogenemia (Fg > 4 g/L) and its time to~     onset.~   "
80795|NCT02509377|"~     Inclusion and exclusion criteria for fetal repair of MMC was established by the Management of~     Myelomeningocele Study (MOMS Trial) and these criteria are the standard of care throughout~     the United States. These criteria state exclusion for hypertension and diabetes which are~     known co-morbidities for obesity. Investigators plan to expand one exclusion criteria for~     open fetal repair surgery. Currently, an exclusion factor is a maternal BMI of 35.0 and~     greater.Investigators will maintain all other inclusion and exclusion criteria (including~     excluding for hypertension and diabetes) with the exception of expanding the BMI to include~     mothers with a BMI of 35.0 to 40.0. Co-morbidities of the research group will be compared to~     the comorbidities of the mothers published in the MOMS trial.~   "
80796|NCT02509364|"~     Idiopathic pulmonary fibrosis (IPF) is a highly heterogeneous and lethal pathological process~     with limited therapeutic options, which is the most common and severe of the idiopathic~     interstitial pneumonias (IIPs). During the past 20 years, the incidence of IPF increased~     significantly. Most of IPF patients show a median survival time of 2-3 years after diagnosis.~     Five-year survival rate is 30%-50%. It's difficult to diagnose in the early stage of IPF.~     Once the patients go to hospital, it's already in the late stage. Now there is no effective~     therapy except lung transplant for IPF in clinical application.~      Acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF) is a fatal condition with high~     mortality (over 80%). Its etiology and pathogenesis remain unknown. There is a lack of~     effective treatment for it. Based on the investigators' long-term clinical observation, most~     cases of AE-IPF initially got common cold and had coryza, more cough, nasal~     obstruction，rhinorrhea, sore throat, some patients had fever, headache, and etc. Some of~     these patients' condition developed very rapidly and then became very severe similar to the~     situation of acute respiratory distress syndrome (ARDS). Why these AE-IPF patients were so~     hypersensitive to cold? What were the immunologic and pathological mechanisms of their lung~     lesions after patients exposed to common cold? How to effectively offer interventional~     treatment for AE-IPF? All the above questions are yet to be explained clearly.~      In the investigators' previous retrospective study, the investigators found that there were~     some obviously imbalanced immune responses in IPF patients, including increased cluster of~     differentiation 4 (CD4) T cell population, immunoglobulin and complements. The investigators~     also found highly expressed inflammatory cytokines (IL-17, MIG and IL-9) and high detection~     rates of pathogens in AE-IPF patients, especially serum immunoglobulin M (IgM) antibody of~     some respiratory virus. These findings provide a strong suggestion that there are some~     imbalance of immunologic function in IPF and there are relationship between AE-IPF and~     infection, especially Cold virus infection might be a key trigger for AE-IPF.~   "
80797|NCT02509351|"~     -  Misoprostol reduces the uterine bleeding after cesarean delivery without harmful effects~          on either mother or baby.~        -  The aim of the this study is to address if there is any benefits 'regarding the~          intra-operative blood loss' from preoperative rectal administration of 400 mic of~          Misoprostol in addition to the routinely administrated 10 units of oxytocin~   "
80798|NCT02509338|"~     The main objective of the trial is to study the technical feasibility of the implantation of~     a new electrode Monocontact deep brain stimulation electrode in dystonia.~   "
80799|NCT02509325|"~     The purpose of the study is to investigate the feasibility of using the commercially~     available Parkinson's KinetiGraph Data Logger (PKG) to quantitatively assess motor~     fluctuations in Parkinson's Disease (PD) patients. A reliable and objective assessment of~     motor fluctuations would support the general neurologists in the referral of PD patients to~     the Deep Brain Stimulation (DBS) surgical centers and facilitate the DBS eligibility~     evaluation of PD patients usually done by the DBS specialists at the DBS surgical centers.~   "
80800|NCT02509312|"~     This is a randomized, double blind placebo trial to evaluate whether ketorolac given at the~     time of cord clamp has any impact on post-partum pain control. Patients will be randomized to~     either placebo or ketorolac prior to surgery. Those randomized to ketorolac will receive~     ketorolac at cord clamp and 3 additional doses 6 hours apart (total 4 doses/24 hours). Those~     in the placebo group will receive placebo medications during those time periods.~   "
80801|NCT02509299|"~     Chronic obstructive pulmonary disease (COPD) impacts negatively on the quality of life of~     patients. Several studies have shown that acute exacerbations (AEs) decrease health-related~     quality of life, pulmonary function and survival of COPD patients.~      The objective of the present study is to examine the effects of a physical therapy program on~     perceived health status in COPD patients hospitalized due to an acute exacerbation.~   "
80802|NCT02509286|"~     The trial is designed to investigate differences in outcome of patients with esophageal~     adenocarcinoma and junctional adenocarcinoma treated with perioperative (neoadjuvant +~     adjuvant) chemotherapy (FLOT) plus surgical resection versus neoadjuvant chemoradiation~     (CROSS) plus surgical resection.~   "
80803|NCT02509273|"~     Closed1 aims to compare the efficacy, safety and pharmacokinetics of clonidine~     (hydrochloride) to midazolam in the sedation of ventilated children and adolescents (0-18~     years) admitted to a paediatric intensive care unit (PICU) and requiring mechanical~     ventilation and sedation for at least 24 hours.~      In particular, the proportion of subjects with sedation failure at the maximum possible dose~     (defined within the study protocol) will be measured. Additionally, the safety and~     tolerability (including withdrawal effects) of clonidine compared to midazolam will be~     evaluated. A pharmacokinetic-pharmacodynamic relationship of clonidine for sedation in PICU~     will be established. Genetic polymorphisms of clinical relevance affecting pharmacokinetics,~     pharmacodynamics and metabolism will be also identified.~      Ad hoc paediatric parenteral formulations of clonidine hydrochloride and midazolam will be~     manufactured. At least 300 subjects will be enrolled from study centres in five European~     member countries (Czech Republic, Germany, Italy, the Netherlands, and Sweden).~      The clinical study will enrol critically ill paediatric patients who require mechanical~     ventilation and sedation.~      Subjects will be closely followed using standard PICU monitoring of vital functions~     (continuous assessment of heart rate and peripheral arterial oxygen saturation, intermittent~     assessment of systolic and diastolic blood pressure), intermittent assessment of pain and~     depth of sedation, documentation of parameters of mechanical ventilation and intermittent~     arterial blood gas analysis.~      The study will be conducted in compliance with the study protocol, Good Clinical Practice~     (ICH-GCP) and the applicable regulatory requirement(s). In addition, qualified PICU staff~     will be monitoring subjects around the clock, thus minimising reaction time in case of alarms~     or deterioration of clinical parameters.~      This project has received funding from the European Union's Seventh Framework Programme for~     research, technological development and demonstration under grant agreement n° 602453.~   "
80804|NCT02509260|"~     Many strategies have been attempted to reduce SSI rates. The Centers for Medicare and~     Medicaid Services introduced the Surgical Care Improvement Project infection project with the~     aim of reducing SSI incidence and morbidity. These measures include prophylactic intravenous~     antibiotics administered within 1 hour of skin incision, appropriate prophylactic antibiotic~     selection, discontinuation of prophylactic antibiotics within 24 hours after surgery,~     appropriate hair removal, and maintenance of perioperative normothermia. Despite the~     enforcement of these measures through quality reporting and pay-for-performance measures,~     significant controversy exists as to their overall effectiveness, especially in the high-risk~     colorectal surgical population. Laparoscopic surgery has been shown to improve SSI rates in~     the colorectal population; however, not all patients are appropriate candidates for this~     approach and the inability of promising interventions such as wound edge protection and~     gentamicin sponges to improve SSI rates following colorectal surgery mandate the~     investigation of novel techniques.~      The aim of the current study is to assess the clinical effectiveness of incisional NPWT to~     reduce SSI rates in open, re-operative colorectal surgery. The primary endpoint of this study~     is the occurrence of superficial SSI within 30 days after surgery and the secondary endpoints~     include length of hospital stay and cost effectiveness.~   "
80805|NCT02509247|"~     Wireless telemonitoring was used during the habituation phase of continuous positive airway~     pressure (CPAP) treatment in obstructive sleep apnoea (OSA) patients. Patients were allocated~     either to the telemonitoring group (n=50) or the usual care group (n=61). Nursing time,~     patient satisfaction and treatment efficiency and efficacy were compared between the groups~     at baseline and after one year treatment the CPAP adherence and treatment efficacy were~     recorded.~   "
80806|NCT02509234|"~     The purpose of the study is to evaluate patients with refractory childhood sarcomas, who have~     been treated with a combination therapy of trabectedin and irinotecan (within compassionate~     use), to determine, if this is a promising treatment option with acceptable toxicity and if~     the results warrant a prospective study.~   "
80807|NCT02509221|"~     Emergence delirium which is a phenomenon seen commonly in preschool kids anesthetized with~     Sevoflurane. Restless recovery from anesthesia may not only cause injury to the child or to~     the surgical site, but may also lead to the accidental removal of surgical dressings, IV~     catheters, and drains. is one of the The purpose of the study is to find whether duration of~     exposure to Sevoflurane has any effect on the incidence of Emergence Delirium.~   "
80808|NCT02509208|"~     The purpose of this European study is to demonstrate the safety and performance of the~     SurgiClot® dressing in the treatment of cancellous bone bleeding.~   "
80809|NCT02509195|"~     The purpose of this study is to identify the effects that ageing may have on the drug levels,~     the safety and the efficacy of Dolutegravir.~      These effects will be measured in people who are aged 60 or over and taking antiretroviral~     therapy for HIV infection.~      Dolutegravir is a newly licenced anti HIV medication, which belongs to a class of drugs~     called Integrase Inhibitors. It is taken with two other wellknown agents, Abacavir and~     Lamivudine, as part of a one tablet once a day regimen, called Triumeq. There is little data~     available on Dolutegravir in the context of older age. The HIV population is ageing and the~     investigators know that older age can significantly change the effects and side effects of~     medications, including that of antiretrovirals.~      The investigators aim to investigate the treatment outcomes in older people taking~     Dolutegravir including the tolerability, efficacy and safety of the drug.~      The study will also assess the quality of life (wellbeing of individuals) and cognition~     (mental abilities) of people aged 60 or over, taking Dolutegravir. The results from this~     study may inform treatment choices and monitoring in this population in the future.~      The duration of involvement in the study will be 6 months with an additional screening visit~     and a checkup visit 10 days after end of study visit.~   "
80810|NCT02509182|"~     The purpose of this study is to test the hypothesis that decreasing the inspired oxygen~     concentration during thoracic surgery requiring one lung ventilation will improve~     post-operative oxygenation.~   "
80812|NCT02509156|"~     The primary purpose of this study is to examine the safety and feasibility of delivering~     allogeneic human mesenchymal stem cells (allo-MSCs) by transendocardial injection to cancer~     survivors with left ventricular (LV) dysfunction secondary to anthracycline-induced~     cardiomyopathy (AIC).~      The secondary purpose of this study is to obtain preliminary evidence for therapeutic~     efficacy of allo-MSCs delivered by transendocardial injection to cancer survivors with LV~     dysfunction secondary to AIC.~   "
80813|NCT02509143|"~     Objectives: This study aims to assess the effectiveness, safety, and feasibility of intensive~     acupuncture treatments combined with standard antiemetic medication as compared with P6~     acupoint stimulation combined with standard antiemetic medication or with standard antiemetic~     medication alone, to prevent postoperative nausea and vomiting (PONV) in patients undergoing~     laparoscopic colorectal surgery.~      Background: PONV is one of the prevalent discomforts in the early phase of recovery after~     surgery. Evidence suggests that the stimulation of the P6 acupuncture point can reduce the~     occurrence of PONV. What remains unclear is whether a higher dose of acupuncture produces~     more benefits compared with P6 stimulation alone or whether acupuncture combined with~     standard antiemetic medication yields better outcomes. This study aims to assess the~     effectiveness and safety of different acupuncture regimen for the prevention of PONV:~     high-dose acupuncture treatments combined with standard antiemetic medication, P6~     acupuncture-point stimulation combined with standard antiemetic medication, or medication~     alone.~   "
80814|NCT02509130|"~     MISSION is a new and novel way of delivering highly specialised asthma care and has the~     potential to change the way asthma care across the United Kingdom (UK) is delivered as well~     as services for other long term health conditions. The MISSION model is the first model of~     this type and the current research study aims to evaluate its success and to compare the~     MISSION service to current care delivery. This will be done in several different ways. The~     study is a mixed methods evaluation of the new service comparing outcomes before and after~     the intervention using retrospective data analysis and prospective qualitative interview. A~     control arm of patients not exposed to, but eligible for, the new intervention will also be~     included. The study will be conducted at Portsmouth Hospitals National Health Service (NHS)~     Trust and will recruit patients who attended MISSION clinics, outpatient asthma clinics,~     staff who attended MISSION clinics in a professional capacity and patients from GP surgeries~     where MISSION clinics were held who did not attend.~   "
80815|NCT02509117|"~     The purpose of this study is to evaluate the safety, tolerability, PK and PD of PF-06751979~     following oral doses in healthy adult and healthy elderly subjects.~   "
80816|NCT02509104|"~     The primary objective of this study is to determine the bioavailability of a FDC capsule~     formulation of dutasteride and tamsulosin hydrochloride (0.5 milligram [mg]/0.2 mg) relative~     to coadministration of one dutasteride 0.5 mg capsule and one tamsulosin HCl 0.2 mg tablet in~     healthy male subjects in fed and fasted states. This is an open-label, randomized, single~     dose, two-way crossover study enrolling healthy male subjects, split into fasted (Cohort 1)~     and fed (Cohort 2) conditions. In both cohorts, one FDC capsule formulation of dutasteride~     0.5 mg/tamsulosin HCl 0.2 mg will be administered in one treatment period and the~     coadministration of dutasteride and tamsulosin hydrochloride in a different treatment period.~     Each subject enrolled will be allowed to participate in only one cohort (i.e, will receive~     treatment under fasted or fed conditions) and will participate in both treatment periods. The~     two treatment periods will be separated by a minimum washout period of 28 days. The total~     duration in the study for each subject will be approximately 2.5 months from screening to the~     final follow-up visit.~   "
80817|NCT02509091|"~     The therapy of bronchoalveolar lavage and local amikacin injection as one of the treatment of~     bronchiectasis developed in recent years.this study is aim to evaluate the Clinical Efficacy~     and Safety of Therapy of Bronchoalveolar Lavage and Local Amikacin Injection in Patients with~     Acute Exacerbation of Bronchiectasis.~   "
80818|NCT02509078|"~     This study evaluates whether giving a neuromuscular blocker (skeletal muscle relaxant) to a~     patient with acute respiratory distress syndrome will improve survival. Half of the patients~     will receive a neuromuscular blocker for two days and in the other half the use of~     neuromuscular blockers will be discouraged .~   "
80819|NCT02509065|"~     The current study is designed to determine the effect on mean glucose, hypoglycemia, glucagon~     usage, and insulin usage of adjusting upward the glucose target of the bi-hormonal bionic~     pancreas, and determine whether there is a target at which adequate glycemic control is~     achieved by an insulin-only bionic pancreas with minimal hypoglycemia.~   "
80820|NCT02509052|"~     This phase I/II trial studies the side effects and best dose of leflunomide in treating~     patients with multiple myeloma that has come back (relapsed) or has not responded to previous~     treatment (refractory). Leflunomide may stop the growth of cancer cells by blocking some of~     the enzymes needed for cell growth.~   "
80821|NCT02509039|"~     To determine the safety and tolerability of CC-122 when administered orally to adult Japanese~     subjects with advanced solid tumors or Non-Hodgkin's Lymphoma (NHL) and to define the maximum~     tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).~   "
80822|NCT02509026|"~     The purpose of this study is to study the benefits and risks of etanercept withdrawal in~     patients who have achieved a significant clinical response.~   "
80823|NCT02509013|"~     This is a prospective, multi-center, hospital-based observational study. The aim of the study~     is to evaluate the prevalence of chronic kidney disease in patients with stable coronar heart~     disease.~   "
80824|NCT02509000|"~     This study aimed to assess the impact of air filtration on indoor air quality and~     cardio-pulmonary health in residents living in high outdoor pollution settings in Beijing.~   "
80825|NCT02508987|"~     The aim of the study is to evaluate the effect of obesity on periodontally healthy or~     diseased tissues.Normal weight and obese subjects were analyzed in 6 groups. Clinical~     periodontal status was determined through plaque index, gingival index, bleeding on probing,~     pocket probing depth, clinical attacment level and radiographs.~      Oxidative stress is known to contribute to various diseases by affecting cellular functions~     through the oxidation of proteins, lipids and DNA. Oxidative stress can be assessed by~     measuring the products of oxidative damage found in proteins, lipids and DNA or reductions in~     total antioxidant capacity Malondialdehyde, protein carbonyl and total antioxidant capacity~     levels are biomarkers of oxidative stress in gingival crevicular fluid.~   "
80826|NCT02508974|"~     Malnutrition of patients on admission to hospitals are estimated to be as high as 60%,~     although the prevalence varies between countries. The impact of malnutrition on patient~     recovery and discharge is severe, with extensive cost implications. This study aims to assess~     the prevalence of at risk for malnutrition among adult patients admitted to hospital across 3~     countries on the African continent.~   "
80827|NCT02508961|"~     The study will be a pragmatic, single blind, randomised, controlled feasibility study,~     comparing 6 months of web-based physiotherapy plus usual care with usual care alone in pwMS.~     The study will recruit 90 pwMS from three UK Centres (30 from each centre); NHS Ayrshire and~     Arran, NHS Lothian, and Plymouth Hospitals NHS Trust.~      The aim of this study is to assess the feasibility of a randomised controlled trial examining~     the effectiveness of a six-month web-based physiotherapy programme and usual care compared to~     usual care alone, in people moderately affected by MS and to gather essential information for~     the planning of a definitive trial, which would evaluate both clinical and cost effectiveness~     of the intervention.~   "
80828|NCT02508948|"~     To further examine current intubation practice among critically ill patients who are in need~     of endotracheal intubation, the investigators plan to perform a prospective cross-sectional~     study of adult critically ill patients who needed endotracheal intubation at participating~     sites between August 1st, 2015 to August 1st, 2016. The investigators aim to describe the~     current intubation practice among the participating sites with a description of complications~     that may have surfaced during the peri-intubation period and to isolate predictive factors of~     these complications.~      In this study, the primary aim is to describe, through a prospective cross-sectional study,~     the current intubation practice of adult critically ill patients undergoing endotracheal~     intubations with secondary aims exploring complications that may emerge during the~     peri-intubation period and to isolate predictive factors of these complications. This~     information will generate hypotheses which will lead to further study with the ultimate~     impact of reducing patient-related outcomes such as morbidity and mortality.~   "
80829|NCT02508935|"~     Phase 4, multicenter, open-label, multiple-dose study of the pharmacokinetics (PK) and safety~     of XARTEMIS XR in postsurgical adolescent subjects aged 12 to 17 years with moderate to~     severe acute pain. The study will assess the safety of administering multiple doses of~     XARTEMIS XR in this population.~   "
80830|NCT02508922|"~     To build on a recent case study and open label trial, the investigators want to find out if~     vitamin D supplementation can influence behavioural and core symptoms of autism.~   "
80831|NCT02508909|"~     Groin lymph node dissection for melanoma patients is burdened by high post-operative~     morbidity, mainly related to wound. This is a prospective pilot trial investigated~     feasibility and postoperative outcomes of videoscopic ilioinguinal lymphadenectomy in~     patients with inguinal lymph node melanoma metastases.~   "
80832|NCT02508896|"~     Study AFF012 is a single blind, single-center, randomized, placebo-controlled, parallel~     group, phase I clinical trial of repeated administration by subcutaneous injection of a~     single dose of one of two different proprotein convertase subtilisin/kexin type 9 targeting~     AFFITOPE® vaccines or Placebo. This study will assess Safety, Immunogenicity and low density~     lipoprotein cholesterol-lowering activity of the two vaccines.~      72 healthy subjects are divided into three test groups (2 treatment groups, 1 placebo group),~     each consisting of 24 subjects. The subjects are randomized to receive either of two~     AFFITOPEs® (AT04A or AT06A, adsorbed to 1 mg aluminium oxyhydroxide) or placebo (1 mg~     aluminium oxyhydroxide).~      The study consists of 3 parts, part A, encompassing Visit 1 to Visit 8, covering 3 priming~     immunizations at a dose of 15μg at days 0, 28 and 56 and the immediate observation period~     extending to day 140; the prolonged observation period: part B, encompassing Visit 9 and~     Visit 10 at days 273 and 365; and part C consisting of 7 visits (V11 to V17). Study~     participants having received 3 priming vaccinations and having completed part B will receive~     in part C one boost immunization at a dose of 75μg, which will be applied one year after the~     3rd immunization (day 420). Probands will proceed directly from part A to part B and to part~     C. Continuation of parts B and C will be considered based on the part A results, primarily~     the immunological results. The following scenarios apply (provided that there is no safety~     issue). None of the two treatment groups exhibits a vaccine-specific antibody response over~     the placebo group at Visit 8 - this will lead to termination of the trial. One of the two~     groups fails to exhibit a vaccine-specific antibody response over the placebo group at Visit~     8 - this will lead to its discontinuation; the other treatment group and the placebo group~     will be continued.~   "
80833|NCT02508883|"~     This is a prospective and observational study to evaluate oncologic patients that presented~     upper gastrointestinal bleeding with the use of some prognostic scores.~   "
80834|NCT02508870|"~     This is a multicenter, open-label, Phase 1b study of atezolizumab (anti-programmed~     death-ligand 1 [anti-PD-L1] monoclonal antibody) in participants who have hypomethylating~     agent (HMA)-naïve myelodysplastic syndromes (MDS) and are International Prognostic Scoring~     System-Revised (IPSS-R) intermediate/high/very high-risk, or have MDS relapsed or are~     refractory (R/R) to prior HMA therapy. The primary objectives of this study are to determine~     the safety and tolerability of atezolizumab therapy in these participant populations,~     including treatment in combination with azacitidine.~   "
80835|NCT02508857|"~     Magnesium sulfate has been reported to improve postoperative pain, but evidence is still~     controversial. Some studies demonstrated benefits while others concluded that there is no~     efficacy. Aim: the aim of the study was to compare the effect of intravenous infusion of~     magnesium sulfate to ketorolac during laparoscopic gynecologic oncology surgeries. Methods:~     We designed a double-blind randomized controlled trial that compared intravenous magnesium~     sulfate to ketorolac and saline solution in postoperative pain, morphine consumption and~     opioid related side effects.~   "
80836|NCT02508844|"~     The purpose of the study is to investigate if the probiotics Vivomixx® can affect gestational~     weight gain, microbiota and pregnancy complications in pregnant obese women and birth weight~     body composition of their infants.~   "
80872|NCT02508376|"~     This is a phase I randomized, double blind clinical trial designed to evaluate the safety,~     tolerability and immunogenicity of the ID93 recombinant protein antigen alone or formulated~     with GLA-SE or AP10-602 adjuvant in 70 healthy adults 18-49 years of age. Subjects will~     receive a total of 3 doses administered intramuscularly on Days 1, 29 and 57. Subjects will~     be monitored for approximately 422 days (365 days following the third study injection),~     including safety laboratory analyses done just prior to and 7 days following each study~     injection. Blood samples will be obtained for immunological assays (Luminex, intracellular~     cytokine staining at Days 1 and 71, and antibody analysis at Days 1 and 85). The primary~     objective is to evaluate the safety and tolerability of 10 µg ID93 + 5 or 10 µg AP10-602~     compared to 10 µg ID93 + 5 µg GLA-SE and 10 µg ID93 alone following three consecutive~     intramuscular injections administered on Days 1, 29 and 57.~   "
80837|NCT02508831|"~     The case of patients with amputation of forearm on one side and arm on the other is~     particularly interesting to study because in this situation of handicap greater than a double~     amputation in forearm. We should bring a functional benefit to the patient with the~     transplant of forearm and this situation allows to have the best possible control to compare~     the result of the transplant of arm to that of forearm because it is realized at the same~     patient.~      Amputation of both arms deprives patients of an elbow what establishes a major factor of~     limitation of autonomy and makes patients totally dependent for the realization of the~     essential gestures of the current life requiring the prehension (dress, dressing, food,~     hygiene of the elimination). The various equipments are not always adaptable and usable.~     Psychologically, an amputation in arm is unanimously considered as an infringement very badly~     accepted of the physical integrity and establishes a major handicap factor of family,~     professional and social exclusion.~      The results of this study should allow a better appreciation of indications and modalities of~     care of biamputed patients with at least one lesion level above the elbow.~      This clinical research will determine the potential place of a reconstructive surgery as~     allograft in biamputed patients on the basis of functional results and assessment of~     disorders of the body schema perception.~   "
80838|NCT02508818|"~     There are no equivalent experiment setups to create comparable changes of gravitation such as~     during parabolic flights. To determine the initial orthostatic responses of the~     cardiovascular system under the gravitational conditions of mars and moon is an essential~     step for a better understanding of 1) the fundamental functions of the human cardiovascular~     system (basic research) 2) specific impact of partial-g on the human heart, lungs and vessels~     in a spaceflight-context 3) approaches for countermeasure development against orthostatic~     intolerance on moon and mars (applied research).~      Non-invasive measurement methods will be used to achieve the cardiovascular key values of the~     study: stroke volume (SV) and cardiac output determination by pulse contour analysis,~     impedance cardiography and inert gas rebreathing, beat-to-beat finger blood pressure~     measurement, heart rate and heart rate variability determination by ECG. All of these methods~     have proven their accuracy during parabolic flights. Nevertheless pulse contour analysis and~     impedance cardiography are known to provide only relative SV and CO values. Thus inert gas~     rebreathing gives us the possibility to calibrate these stroke volumes and cardiac outputs to~     absolute values. Success of this procedure was shown during former parabolic flights.~   "
80839|NCT02508805|"~     The purpose of the study is to assess the efficacy and safety of Neuromultivit (solution for~     injections) in treatment of vertebrogenic radiculopathy L5, S1 in comparison with standard~     therapy. The patients are randomised into two groups: standard therapy group and standard~     therapy plus Neuromultivit group.~   "
80840|NCT02508792|"~     Heart failure (HF) is an important public health problem being considered an emerging~     epidemic, therefore, strategies are essential to improve symptoms and to decrease the money~     expenditure on healthcare. Based on the knowledge about the syndrome of heart failure, new~     approaches are needed to decrease the symptoms, to enhance the quality of life of these~     patients and highlight the non-pharmacological therapies such as the use of phototherapy. The~     objective of this study is to study the effect of low level laser therapy in muscle function~     and tissue oxygenation of the lower limbs in patients with heart failure. It is a randomized,~     double-blind, including 20 individuals with heart failure, with stable, class II or III~     according to the New York Heart Association (NYHA). It will be evaluated the acute effects of~     a LASER intervention applied before a fatigue protocol throught muscle function and tissue~     oxygenation in the participants. Evaluations will be performed by an isokinetic dynamometer,~     near infrared spectroscopy (NIRS) and electromyography . It will be analyzed the~     concentration of oxyhemoglobin and deoxyhemoglobin, total hemoglobin concentration, the~     difference between these concentrations, muscular torque, fatigue index and muscle~     activation. The data will be subjected to distribution normality test and if they have normal~     distribution, the differences between the interventions will be checked by analysis of~     variance, considering significant ap <0.05. If the data is non-parametric distribution will~     be using the Mann-Whitney or Kruskal-Wallis. The SPSS 19.0 software will be used as a tool~     for data analysis. The investigators expected to find as outcomes of this study an increase~     in peripheral muscle function and tissue oxygenation and also a delay in the development of~     muscle fatigue in patients with HF submitted to acute intervention with LASER.~   "
80841|NCT02508779|"~     Ineffective management of blood glucose (BG) levels during preconception and pregnancy has~     been associated with severe maternal and fetal complications in women with type 1 diabetes~     (T1DM). Preconception care emphasizing stringent glycemic control in the preconception period~     and continued through early pregnancy can dramatically reduce these risks. However, the use~     of preconception care in the US has been disappointingly low due to a variety of~     organizational, provider, and patient centered factors. Furthermore, efforts to achieve tight~     glycemic control can increase the risk of severe hypoglycemia (SH) in T1DM women, potentially~     leading to serious health consequences. In this project, the investigators will test an~     education based Internet intervention (Bump2be or Blood glucose awareness training (BGAT) for~     users who might become pregnant) for use with T1DM women who are either actively trying to~     become pregnant (TP) or planning to become pregnant in the 12 months following their~     enrollment in this study (PP).~      The main objective is to examine Bump2be's feasibility and preliminary efficacy as an~     intervention for these women to better regulate their BG levels and to meet their~     diabetes-related clinical targets for pregnancy. More specifically, Bump2be will be tested in~     a randomized clinical trial in which 58 T1DM women who are either TP or PP will be recruited.~     As part of this pre-post study design, participants will be randomly assigned to either the~     Bump2be intervention (n=29) or the routine care group (n=29). Data collected will include~     frequency of extreme BG, consequences of extreme BG, average BG levels (HbA1c level),~     estimation of BG, detection of low and high BG, and psychological functioning (including fear~     of hypoglycemia, avoidance of hyperglycemia, well-being, and internal locus of control).~     Interviews with up to 10 trial participants will be conducted at the conclusion of their~     study participation, to enable further optimization of the intervention in preparation for a~     subsequent R01 submission. This will be the first study investigating the use of the Internet~     to improve detection and management of extreme BG levels in Diabetes mellitus type 1 (T1DM)~     women who are either TP or PP.~   "
80842|NCT02508766|"~     The primary purpose of this study was to examine the immediate effect of manual stimulation~     on the foot plant in static and dynamic balance in young healthy subjects. In addition, the~     secondary objectives of this study were: 1) to identify whether manual stimulation of the~     foot plant in healthy young subjects, carried out with an easily reproducible protocol with~     10 minutes duration, improves static balance, measured with Unipedal Stance Test; 2) to~     assess whether, manual stimulation of the foot plant in healthy young subjects, carried out~     with an easily reproducible protocol with 10 minutes duration, improves dynamic balance test,~     measured with Star Excursion Balance Test.~   "
80843|NCT02508753|"~     The purpose of the study is look at the possible side effects of two different doses of~     CXA-101/tazobactam, a low dose and a high dose, on participant's heart.~   "
80844|NCT02508740|"~     The purpose of this study is to characterize the effect of renal function on the PK of a 0.25~     mg single oral dose of bevenopran in humans and to assess the safety and tolerability of~     bevenopran in patients with varying degrees of renal impairment and in healthy subjects.~   "
80873|NCT02508363|"~     The investigators are testing different ways of following up with drivers who attend our~     health fairs to find the best way to make sure that taxi drivers go to important medical~     appointments and have a regular doctor to help with their health problems.~   "
80845|NCT02508727|"~     Cardiac exploration almost systematically requires the acquisition and / or calculating~     function indices. The ejection fraction (LVEF) is probably based index most widely used in~     all cardiac exploration methods. This relatively universal overall index has very many~     qualities. LVEF is widely used in clinical practice through the exploration and monitoring of~     all heart disease.~      Current progress in the management of various cardiomyopathies pass through the detection of~     early attacks. This testing often takes place upstream changes in LVEF that remains long~     normal or normalized. Sensitive indicators capable of detecting early abnormalities of~     regional functions are essential in addition to conventional echocardiography. Various~     studies have shown the contribution of these new markers in early detection of abnormalities~     of the cardiac function. The most widely used indicator in these studies because of its high~     sensitivity to analyze the movements of the heart is the tissue Doppler. Tissue Doppler~     however has limitations in particular its dependence on the incident angle, which makes it~     impossible to correct analysis of non-aligned in the axis of the ultrasonic beam components.~      A new way of exploring the regional function of the heart, speckle tracking, can analyze~     heart deformations along the principal axes of the heart. The advantage of this technique has~     been shown in various pathological situations. Currently, this technique is mostly used in~     longitudinal and transverse view 2D imposing multiple planes cuts. 3D potential of this~     technique is not currently known, acquisition of 3D technology is recent (2004) and dedicated~     software is confidential dissemination and unvalidated.~      The validated technique, 3D reference analysis of myocardial deformation is tagged MRI. In~     the 90s, studies have demonstrated the feasibility of this technique, the ability to access~     all of the myocardial deformation in space and to define normal values. The cost of the~     procedure, duration, limited accessibility and post-processing very time consuming limited~     the scope of the clinical benefits of this modality.~      Echocardiography has major advantages over MRI, particularly its high availability, low cost~     and flexibility of use. The ability to access with MRI as the 3D deformation of the heart is~     a new opportunity that it is essential to validate.~      The main purpose of the study is to compare the strain values obtained 3D ultrasound to those~     obtained by MRI tagged in a control group and a group of subjects with an anterior infarction~     sequela.~   "
80846|NCT02508714|"~     The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has~     led to a significant reduction in morbidity. However, the first generation of these devices~     had no positive impact on the mortality after PCI (compared to bare metal stents), which was~     greatly attributed to a somewhat increased incidence of late and very late stent thrombosis.~     Concerns about the role of durable polymers as a potential trigger of inflammation and~     finally adverse events also led to the development of DES with bioresorbable coatings, which~     leave after degradation of the coating only a bare metal stent in the vessel wall that does~     not induce an inflammatory response. While such bioresorbable polymer DES are increasingly~     used in clinical practice, data from head-to-head comparisons between bioresorbable polymer~     DES with a contemporary highly flexible new generation permanent polymer coated DES.~   "
80847|NCT02508701|"~     This is a study testing what type of message and access influences a young male to get the~     HPV vaccine.~      The investigators are conducting a 2 X 2 design~      These conditions are:~        -  Condition 1: Altruistic personal with direct recommendation inside-dorm~        -  Condition 2: Generic message with inside-dorm~        -  Condition 3: Generic message with outside-dorm HPV vaccine~        -  Condition 4: Altruistic personal with outside-dorm HPV vaccine~      The objectives of this study are:~      A. To examine the efficacy in encouraging young men to receive HPV shots at Time 1 within~     each of the four intervention conditions (altruistic/personal with direct recommendation vs.~     generic message) X (in-dorm vs. outside-dorm HPV vaccine).~      B. To examine the efficacy in encouraging young men to receive HPV shots at Times 2 & 3~     within each of the four intervention conditions (altruistic/personal with direct~     recommendation vs. generic message) X (in-dorm vs. outside-dorm HPV vaccine).~      2.1.1 List the clinical hypotheses. Objective A H A.1: At Time 1, college men who have~     immediate access to the HPV vaccination will take the vaccination at a higher rate than those~     who do not have immediate access to the vaccine.~      H A.2: At Time 1, college men who receive an altruistic/personal health message along with~     immediate access to the HPV vaccine will take the HPV vaccination at a higher rate than the~     men in the other three arms of the study.~      Objective B H B.1: At Times 2 & 3, college men who have immediate access to the HPV~     vaccination will take the vaccination at a higher rate than those who do not have immediate~     access to the vaccine.~      H B.2: At Times 2 & 3, college men who receive an altruistic/personal health message along~     with immediate access to the HPV vaccine will take the HPV vaccination at a higher rate than~     the men in the other three arms of the study.~   "
80848|NCT02508688|"~     The management of refractory hepatic hydrothorax is challenging and usually unsuccessful. The~     study will discuss the perioperative treatment, effectiveness, and morphology of~     diaphragmatic defects of hepatic hydrothorax in thoracoscopic mesh repair. Risk factors~     associated with increased three-month mortality in these critically ill patients will be~     studied.~   "
80849|NCT02508675|"~     The major aim of this project is to investigate the prevalence, recovery patterns and risk~     factors for health related quality of life functional, psychological, societal and economic~     outcome after trauma. Another aim is to validate the WHO Quality Of Life-bref (WHOQOL-Bref)~     questionnaire for the trauma population.~   "
80850|NCT02508662|"~     Objectives:~      Primary Objectives:~      To evaluate the anti-cancer activity of commercially available, targeted anti-cancer~     therapies used off-label for treatment in patients with advanced solid cancer with known~     genomic aberrations.~      Secondary Objectives:~      To determine outcomes of patients who were treated with matched targeted anti-cancer~     therapies based on known genomic aberrations.~      To obtain treatment related adverse events in patients with advanced solid tumor who were~     treated with off -label targeted therapies.~      To determine co-genomic aberrations that may contribute to treatment response or resistance~     mechanisms.~      To determine feasibility of detecting the genomic alterations in plasma, and the genomic~     evolution of circulating biomarkers.~   "
80851|NCT02508649|"~     This is a double-blind, randomised, placebo-controlled, two-part adaptive clinical trial. The~     trial is designed to investigate the efficacy and safety of multiple dosing regimens of~     selepressin and to confirm the efficacy and safety of one dosing regimen in treatment of~     adult patients with septic shock requiring vasopressor.~   "
80852|NCT02508636|"~     This is a phase II study to evaluate efficacy, safety, toxicity, and feasibility of the~     addition of enzalutamide to leuprolide for a total duration of 24 months in patients with~     very high-risk prostate cancer or pelvic node positive disease receiving radiotherapy. Very~     high-risk prostate cancer is defined as 2 or more of the following characteristics: 1)~     cT3a/b, 2) PSA ≥20 and <150, 3) Gleason 8-10, and 4) ≥33% core involvement.~   "
80853|NCT02508623|"~     The purpose of this study is to assess whether the add of Rifaximin in patients with liver~     cirrhosis and esophageal varices treated with a standard therapy with beta blockers, leads to~     a significant reduction of portal hypertension.~   "
80854|NCT02508610|"~     This is protocol is generated in response to the exploratory R21 from the National Institutes~     of Health/National Institute of Allergy and Infectious Diseases (NIH/NIAID) for US-Russia~     collaborative research in HIV/tuberculosis (TB). Given the exploratory focus of the protocol~     and the short time frame of funding (2 years) we will study TB in Irkutsk, in Eastern~     Siberia. Irkutsk is one of the hardest-hit areas in all of the Russian Federation for~     drug-resistant TB and poor TB outcomes. Specifically, the investigators will examine the~     factors of anti-TB drug pharmacokinetics, TB drug-resistance mutations and~     virulent/transmissible M. tuberculosis sublineages. This foundational work will inform future~     diagnostic strategies and therapeutic regimens.~   "
80874|NCT02508350|"~     The first objective of this study was to characterize the pharmacokinetics and~     pharmacodynamics of daptomycin with a daily dose of 12mg/kg in septic shock patient; the~     second objective is to identify the optimal dosing scheme for daptomycin among patients with~     septic shock and to enhance therapeutic outcomes.~   "
80875|NCT02508337|"~     The purpose of this study is to evaluate the clinical efficacy and safety of XG-102 (900µg)~     compared to vehicle in the treatment of subjects with inflammation and pain following~     cataract surgery.~   "
80855|NCT02508597|"~     Physicians play a critical role in reducing tobacco use by advising smoking patients to quit.~     After receiving such advice to quit smoking, patients were more likely to report trying to~     quit, quitting for at least 24 hours, making more quit attempts, and having more successful~     quitting outcomes compared with those who received no such advice. On the other hand, most~     physicians are not performing smoking cessation counselling, and miss the opportunities to~     advise patients to quit smoking. One of the common reasons is the lack of time. Physicians~     are busy and cannot afford even one minute to advice their patients to quit smoking. Other~     barriers include lack of training and experience, lack of knowledge and skills, no awareness~     about the benefits and effects of physicians' advice, no incentives and no support or~     requirement from hospital management that they have to do it.~      We designed a brief smoking cessation counselling model (AWARD) which takes only 10-20~     seconds. We will train the physicians to perform the AWARD cessation counselling model in~     clinic, and encourage them to participate in our brief smoking cessation intervention project~     using the randomized controlled trail (RCT) design and to train more peer physicians to~     perform brief smoking cessation counseling. We propose to investigate the effect of the~     training program on physicians' knowledge of tobacco cessation, practice of performing~     cessation counselling, and attitudes toward tobacco control policies.~   "
80856|NCT02508584|"~     M. A. suffers from hypogammaglobulinemia that has been complicated by refractory Mycoplasma~     hominis septic arthritis. He has been receiving the antibiotic valnemulin under Emergency~     Investigational New Drug (eIND) 114686 following many prior treatments with standard~     antibiotics. M.A. has also been receiving intravenous immunoglobulin (IVIG) replacement. The~     antibiotic and IVIG have been helpful, but not sufficient for cure. Antibodies have been~     shown to be critical for defense against mycoplasma. Hyperimmune serum against mycoplasma~     isolated from rabbit or goat has been effective in cases of chronic erosive arthritis in the~     setting of immune deficiency, and in some cases resulted in cures. The investigators propose~     to use M. hominis isolated from M. A. to vaccinate one transgenic cow (developed by SAB~     Biotherapeutics), purify human antibody after vaccination, test the purified antibody in~     killing assays to confirm potency, and then administer the purified human IgG to M. A. after~     FDA compassionate use IND application and local Institutional Review Board (IRB) approval.~   "
80857|NCT02508571|"~     This is randomized controlled trial investigating the effects of direct swallowing training~     and oral sensorimotor stimulation in preterm infants on oral feeding performance.~   "
80858|NCT02508558|"~     Previous studies have neglected two important aspects for the China National Space~     Administration. First, while biomechanical models are very sensitive to the characteristics~     of the subjects, data have been collected on subjects with biomechanical characteristics very~     different from those of typical Chinese astronauts. Second, pure video analysis techniques~     and kinematic data lack the necessary acceleration information important to understanding the~     forces exerted during movement and control of human motion. While some studies used force and~     moment sensors to aid in robot torque control and human joint work estimation, investigators~     are unaware of any studies performed in a microgravity environment that have combined the~     kinetic force and moment information with acceleration measurements to enable more reliable~     motion tracking without the need for acceleration estimation.~      This is why MICR0-G sensors and accompanying kinematic video system have been developed in~     order to provide for detailed analyses of the astronaut movement control strategy (joint~     forces and torques, kinetic and acceleration measurements). Knowledge of the joint torques~     permits us to calculate the joint and musculoskeletal dynamics required to execute the~     microgravity motions, as well to provide insight into the altered movement strategies in~     reduced gravity as compared to 1-G locomotion.~   "
80859|NCT02508545|"~     Parabolic flight is the only ground-based condition in which weightlessness (0G) can be~     created long enough for safely testing changes in human perception and behavior. In addition~     to the 0G period, parabolic flight generates equal duration periods of 1.8G, which present~     another unique opportunity to test the same responses to hypergravity and back to 1G.~      Cognitive function, together with good oculomotor control, eye-hand coordination, and spatial~     orientation perception, is a critical subsystem that is used by the CNS in the control of~     vehicles and other complex systems in a high-level integrative function. Evidence from space~     flight research demonstrates that the function of each of these subsystems is altered by the~     transitions in gravito-inertial force levels. These neuro-vestibular alterations,~     unfortunately, correspond to mission phases where physical and cognitive performance are~     particularly critical for crew safety and mission success. To date, there is only limited~     operational evidence that these alterations cause functional impacts on mission-critical~     vehicle (or complex system) control capabilities. However, the true operational risks will be~     estimable only after the investigators have filled the knowledge gaps and when the~     investigators can accurately assess integrated performance in off-nominal operational~     settings.~      Accurate perception of self-in-space motion and self-motion relative to other objects are~     critical to piloting, driving, and remote manipulator operations. Immediately after space~     flight, most crewmembers have reported some degree of disorientation/perceptual illusion,~     often accompanied by nausea (or other symptoms of motion sickness), and frequently manifested~     by lack of coordination, particularly during locomotion. Despite recent, intensive training,~     some Shuttle landings were outside of the desired performance boundaries. Scores indicating~     neurovestibular dysfunction in returning astronauts generally correlated with poorer flying~     performances, including a lower approach and landing shorter, faster, and harder. An~     underestimation of distance, coupled to an overestimation of tilt magnitude or misperception~     of the type of motion, could be at the origin of these poorer performances.~      This study should confirm that the unloading of the otoliths in weightlessness induces an~     alteration in the egocentric reference during space flight. Errors in egocentric localization~     might contribute at a higher level to the computation of misleading world-centered~     representations, and therefore be partly responsible for illusory sensations and motion~     sickness symptoms during space flight, and postural instability and oscillopsia after~     returning in a reduced or terrestrial gravitational force level.~      Beside their fundamental implications, the results of this study have also practical~     implications in the design of man-machine interfaces. Changes in judgment of distance in~     microgravity or in reduced gravity affect crew posture and reach, display orientation, and~     other visual cues, which should be considered in hardware and operations design.~   "
80860|NCT02508532|"~     This is a Phase 1, open-label, first-in-human (FIH) study designed to evaluate the safety,~     tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antineoplastic activity of~     avapritinib (formerly BLU-285), administered orally (PO), in adult patients with unresectable~     GIST or other relapsed or refractory solid tumors. The study consists of 2 parts, a~     dose-escalation part (Part 1) and an expansion part (Part 2).~   "
80861|NCT02508519|"~     The aim of the study is to investigate how effective is zonal acupuncture method compared to~     balance method to obtain a short coming pain relief effect, which takes place several minutes~     after needle insertion.~   "
80862|NCT02508506|"~     This study will evaluate the effect of various degrees of renal function on the~     pharmacokinetics and safety of ALKS 5461.~   "
80863|NCT02508493|"~     Cognitive dysfunction is a highly persistent, pervasive and progressive abnormality in young~     adults (i.e., 18-65 years) with MDD. It has also been shown that among adults with MDD who~     are gainfully employed, measures of cognition are a greater determinant of overall workplace~     performance than is total depression symptom severity. Several lines of evidence indicate~     that cognitive deficits that persist between episodes of depression are critical determinants~     of functional recovery in the workplace. The functional implications associated with~     cognitive impairment provide the impetus for systematic evaluation, measurement and~     assessment of the domains of cognition expected to be impaired in this patient population.~      To date, no measurement tool has been sufficiently validated and/or determined to be~     sensitive to the cognitive deficits in younger adults with MDD. Major limitations of~     available comprehensive psychometric tools include relative lack of availability, cost, lack~     of access to most healthcare providers, and above all else, the lengthy time to administer.~     Moreover, the need for a psychometrist to interpret the results adds to the complexity and~     the costliness of such an endeavor.~      It is imperative that any tool recommended for clinical utility be aligned with the busy~     nature of a high-volume clinical practice. The ideal gold standard tool for assessing the~     presence of cognitive dysfunction in MDD in the clinical environment should include, but not~     be limited to, features such as good conceptual coverage of cognitive domains affected in~     MDD, good sensitivity and reliability, and it should be relatively uninfluenced by culture~     effects and practice effects. The tool would also need to be brief, easy to administer and~     interpret, and complement busy clinical practice.~      This study is designed to validate a brief user-friendly tool capable of detecting deficit in~     cognitive performance among adults with MDD. Data will be gathered with the aim to determine~     whether the proposed tool identifies cognitive deficits in adults with MDD and differentiates~     the clinical MDD population from healthy controls.~      It is anticipated that the THINC-it tool will be free of charge and downloadable from the~     THINC-it website for use in the primary care and specialty setting. The THINC-it tool will be~     accessible via computers/tablets, will take 20 minutes to self-administer in a clinical~     setting, and the performance results will be immediately available.~   "
80891|NCT02508116|"~     This is a randomized, prospective, open label study to determine the cost-effectiveness of~     genotype-guided antiplatelet therapy. Patients undergoing percutaneous intervention (PCI)~     with stent implantation, will be randomized either to genotype guided dosing of antiplatelet~     therapy or usual care. The study utilizes a novel genotyping device, SpartanRx, to determine~     CYP2C19 genotypes from a buccal swab sample with 1 hour turnaround time.~   "
80864|NCT02508480|"~     We are conducting a randomized clinical trial (RCT) comparing the 10-week peer-led Photovoice~     program to services as usual (SAU) at a large publicly funded community mental health agency~     in Massachusetts. The control SAU condition will be enhanced with a 60-minute peer-led group~     educational session about understanding and coping with prejudice and discrimination. The~     10-session, peer-led Photovoice program, designed to empower individuals with serious mental~     illness (SMI) to confront public prejudice and discrimination and reduce personal stigma~     (self-stigma and perceived stigma), was developed and pilot tested at our Center, with~     primary contributions from staff with a lived experience of mental illness. Development of~     the Photovoice program was guided by an adaptation of the stress-coping model, informed by~     recent research and conceptualizations of the effects of stigma on people with SMI. The~     stress-coping model explicates the mechanisms by which public stigma about mental illness can~     lead to personal stigma, which in turn has a negative impact on the person's mental health~     and psychosocial functioning. This model also identifies critical factors that contribute to~     personal stigma or protect against it, as well as more vs. less adaptive coping responses,~     that are the primary focus of the Photovoice program.~   "
80865|NCT02508467|"~     This is a Phase 1, open-label, first-in-human (FIH) study designed to evaluate the safety,~     tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antineoplastic~     activity of BLU- 554 administered orally in patients with FGF19 IHC+ hepatocellular carcinoma~     (HCC). The study consists of 3 parts, a dose-escalation part (Part 1), an expansion part~     (Part 2) exploring a once daily (qd) dosing schedule at the recommended Phase 2 dose (RP2D),~     and a Part 3 expansion of the qd dosing schedule at the RP2D in TKI naive patients.~   "
80866|NCT02508454|"~     The Miami Heart Study at Baptist Health will be an observational, longitudinal and~     prospective cohort study in a target population of 4000 healthy subjects (40-65 years old)~     consisting of members from the Greater Miami Area (including eligible BHSF(Baptist Health~     South Florida) employees). Baseline examination will consist of (1) assessment for~     cardiovascular risk factors (including lifestyle and psychosocial factors); (2) screening for~     subclinical atherosclerosis using Coronary CT angiogram, Coronary Artery Calcium (CAC)~     testing, vascular 2D/3D ultrasound, endothelial function, arterial stiffness and (3) blood~     sampling for determination of traditional risk factors, advanced omics and biobanking.~     Participants will be followed yearly via telephone, email, or mail for change in health~     status with a focus on cardiovascular disease events, including acute myocardial infarction~     and other forms of coronary heart disease (CHD), stroke, and congestive heart failure;~     mortality; and for cardiovascular disease interventions.~      The Miami Heart Study at Baptist Health is expected to identify new imaging and biological~     factors associated with the presence and feature of earliest markers of subclinical~     atherosclerotic disease and provide opportunities for discovery/validation of novel~     biomarkers to identify these high-risk features. This is expected to lead to advances in~     understanding of evolution and progression of atherosclerotic cardiovascular disease starts~     with an ultimate goal of establishing more personalized, evidence-based approach to medical~     care.~   "
80867|NCT02508441|"~     This is a first-in-human, open-label, dose escalation and expansion, 2-part study to~     determine the safety, tolerability, and maximum tolerated dose of Andes-1537 for Injection in~     patients with advanced unresectable solid tumors that are refractory to standard therapy or~     for which no standard therapy is available.~   "
80868|NCT02508428|"~     The purpose of the study is to determine whether crosslinked Marathon and standard Enduron~     polyethylene liners show differences in survivorship due to wear-related revisions at minimum~     14-year follow-up and every 5 years after.~   "
80869|NCT02508415|"~     Obesity is an epidemic with increasing prevalence in the Asia Pacific region. The first~     Malaysian national estimate in 1996 of obesity was 5.8%. A systematic review reported a~     marked increase in obesity in 2003, 2004 and 2006 with 12.2%, 12.3% and 14.0% respectively.~      Periodontal disease is a chronic inflammatory disease which results in gingival inflammation,~     irreversible attachment loss, alveolar bone destruction and eventually tooth loss. Worldwide,~     the prevalence of periodontitis in the adult population is about 10-15%. Periodontal disease,~     through inflammation and destruction of the periodontium produces clinical signs and~     symptoms, some of which may have a considerable impact on quality of life (QoL).~      A positive association between obesity and periodontal disease was repeatedly demonstrated~     worldwide. Obese individuals have elevated levels of circulating TNF- α and IL-6 compared to~     normal weight individuals. These cytokines decrease after weight loss. Adipokines produced by~     adipose tissue could be one of the mechanisms mediating the association between obesity and~     periodontal disease. This suggests that obesity may have the potential to modify the host's~     immunity and inflammatory system.~      This project will extend the existing information on the association between obesity and~     periodontal disease including QoL aspect to a Malaysia population. It will also improve~     knowledge on the cellular and molecular mechanisms that underpin obesity-periodontal disease~     relationship. By extension, this study also will cast light on the effects of periodontal~     interventions for the subgroup population.~   "
80870|NCT02508402|"~     ABSTRACT:~      Objective: To evaluate the efficacy of dexamethasone on labor duration and to establish~     whether dexamethasone plays a role in shorting the duration interval between initiation of~     labor induction and beginning of the active phase in primigravida full-term pregnancy.~      Methods: case control study included 86 primigravidae with full term pregnancy classified~     into two groups: The participant of Group I will receive a prefilled syringe with two~     milliliters (8 mg) of Dexamethasone intramuscular, and the participants of Group II will not~     receive Dexamethasone or any other cervical ripening agent.~      Key Words: Dexamethasone;post-term pregnancy;induction of labor.~   "
80871|NCT02508389|"~     The purpose of the phase 2, GT-201 clinical study is to determine if GC4419 administered~     prior to intensity-modulated radiation therapy (IMRT) reduces the incidence, duration, and~     severity of radiation induced oral mucositis in patients who have been diagnosed with locally~     advanced, non-metastatic squamous cell carcinoma of the head and neck.~   "
80892|NCT02508103|"~     This research study will look at brain and symptom differences among women with severe~     premenstrual mood symptoms. One goal of this study is to look at the effects of taking a~     nasal spray containing oxytocin (a hormone made in the brain) on brain areas involved in~     emotion regulation while viewing pictures during a neuroimaging (fMRI) session. The~     investigators will also look at whether oxytocin improves premenstrual mood symptoms.~   "
80876|NCT02508324|"~     The purpose of this study is to determine the overall safety of adoptive immunotherapy when~     given after chemotherapy for AML/MDS. Adoptive immunotherapy means using an infusion of cells~     from a donor to help fight cancer. The donor cells will be either from the umbilical cord~     blood (UCB) of a newborn baby or they will be cells collected from a relative~     (haplo-identical cells).~      The 2 cohorts that were discussed - adoptive immunotherapy with either UCB or haplo-identical~     stem cells - will be analyzed separately.~      Preliminary data from other centers has suggested that adoptive immunotherapy with cells from~     a relative is an effective approach that may improve remission rates and survival in AML and~     MDS, because they exert anti-cancer effects of their own (so called graft vs leukemia~     effects) and possibly because they hasten recovery of cell counts from chemotherapy. The~     Investigators are interested in confirming these data, but also in testing umbilical cord~     blood cells for the same purpose. Preliminary data indicate that umbilical cord blood cells~     may have more powerful graft vs leukemia effects and cause fewer side-effects.~   "
80877|NCT02508311|"~     Spinal cord injury (SCI), especially involving the cervical and upper thoracic segments, can~     significantly compromise respiratory muscle function. Respiratory complications can ensue,~     including lung collapse and pneumonia, which are the primary cause for mortality in~     association with traumatic SCI both during the acute and chronic phases post-injury. Lesions~     at the level of the cervical or high thoracic spinal cord result in respiratory muscle~     weakness, which is associated with ineffective cough, mucus retention, and mucus plugging.~     Despite the fact that pulmonary complications are a major cause of morbidity and mortality in~     this population, there is a paucity of effective interventions in the SCI population known to~     improve respiratory muscle strength with pharmacologic interventions receiving little to no~     attention. The current objective of this study is to determine the effectiveness of 16 weeks~     of sustained release oral Albuterol to; (1) improve respiratory muscular strength, and (2)~     improve cough effectiveness.~   "
80878|NCT02508298|"~     This is a prospective longitudinal study that will evaluate if changes (pre and post therapy)~     in indocyanine green (ICG) retention test and liver stiff ness (LS) and spleen stiffness (SS)~     as measured by acoustic radiofrequency impulse (ARFI) correlate with changes in portal~     pressure as determined by the hepatic vein pressure gradient (HVPG) in patients with~     compensated hepatitis C virus (HCV) cirrhosis undergoing antiviral therapy.~   "
80879|NCT02508272|"~     Discovery of differences in the host response in patients with systemic inflammation and~     sepsis, and identification of novel, specific markers by using a longitudinal~     clinico-transcriptomic approach.~   "
80880|NCT02508259|"~     This study is designed to test the safety and efficacy of a single, intravenous dose of~     suramin in autism spectrum disorders (ASD).~   "
80881|NCT02508246|"~     This phase I trial studies the side effects and the best dose of WEE1 inhibitor MK-1775 when~     given together with docetaxel and cisplatin in treating patients with stage III-IVB squamous~     cell carcinoma of the head and neck that may or may not be able to be removed by surgery~     (borderline resectable). WEE1 inhibitor MK-1775 may block the growth of tumor cells by~     blocking some of enzymes that are needed for tumor growth and may also help docetaxel and~     cisplatin work better by making tumor cells more sensitive to the drug. Drugs used in~     chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of~     tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them~     from spreading. Giving WEE1 inhibitor MK-1775 with docetaxel and cisplatin before surgery may~     kill more tumor cells and shrink the tumor, allowing patients to undergo surgery to remove~     it.~   "
80882|NCT02508233|"~     Many recent randomised multi-centre trials have used the AOS and the involvement of the~     French-speaking population is limited by the absence of a French version. The goal of our~     study was to develop a French version and validate the psychometric properties to assure~     equivalence to the English original.~   "
80883|NCT02508220|"~     The study compares the short-term tinnitus reduction following a single oxytocin intervention~     with a placebo control condition.~   "
80884|NCT02508207|"~     To evaluate the clinical mechanisms of action in lung and extrapulmonary systems of VX-661 in~     combination with ivacaftor (IVA) (VX-661/IVA) in subjects with cystic fibrosis (CF) who are~     homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR)~     gene.~   "
80885|NCT02508194|"~     This study will be the first assessment of the efficacy of MEDI7510 for the prevention of~     respiratory syncytial virus (RSV) disease. It will also provide estimates of vaccine efficacy~     and of endpoint incidence in the placebo arm. It will also assess the safety and~     immunogenicity of concurrent dosing of MEDI7510 and IIV to expand on the observations made in~     the Phase 1b study of MEDI7510. It will also expand the safety database of participants dosed~     with MEDI7510. The study will also assess the immune response to MEDI7510 in Season 1 and~     Season 2.~   "
80886|NCT02508181|"~     The investigators enrolled pediatric patients who are undergoing strabismus surgery. The~     investigators insert either an I-gel or laryngeal mask airway Supreme and measure the~     intraocular pressures.~   "
80887|NCT02508168|"~     The purpose of this study is to determine the relative bioavailability of alogliptin 12.5~     milligram (mg) and immediate-release metformin 1000 mg when administered as individual~     tablets and as a fixed-dose combination (FDC) product.~   "
80888|NCT02508155|"~     The purpose of this study is to assess the safety, drug levels and effects on the body of~     MEDI7352, in subjects with painful osteoarthritis of the knee.~   "
80889|NCT02508142|"~     This study aims to assess the analgesic efficacy and safety of intravenous 20 mg~     Hyoscine-N-Butylbromide versus placebo for the treatment of abdominal colic associated with~     acute gastroenteritis in the emergency department.~   "
80890|NCT02508129|"~     Insomnia and hypertension are common health problems that often occur together and influence~     each other. This practical, low-cost, clinical trial will evaluate two behavioral treatments~     for insomnia (a brief intervention with therapist contact and a self-guided Internet~     intervention) compared to usual care. Participants will be recruited using the electronic~     health record in their primary care physicians' offices, and will be evaluated for sleep,~     blood pressure, and health outcomes after 9 weeks, 6 months, and 12 months.~   "
80921|NCT02507726|"~     This study evaluates the performance of a new 1-piece ostomy convex appliance in patients~     with enterostomy.~   "
80893|NCT02508090|"~     Genotype 1 CHC participants from Study SPC3649-207 with null response to prior~     pegylated-interferon alpha plus ribavirin will be enrolled into this 36-month extension~     study, designed to evaluate the long-term safety and efficacy after 12 weeks of miravirsen~     monotherapy. Due to the observational nature of the study, miravirsen will not be dosed as an~     investigational product.~   "
80894|NCT02508077|"~     This phase II trial studies how well fluorouracil, leucovorin calcium, and irinotecan~     hydrochloride (FOLFIRI) together with panitumumab work in treating patients with colorectal~     cancer that expresses the RAS and B-Raf proto-oncogene, serine/threonine kinase (BRAF)~     wild-type genes, has spread from the original site of growth to another part of the body~     (metastatic), resists the effects of treatment with prior cetuximab (or panitumumab) plus~     irinotecan hydrochloride-based therapy, and who have failed at least one subsequent~     non-anti-epidermal growth factor receptor (EGFR) containing treatment regimen. Drugs used in~     chemotherapy, such as fluorouracil, leucovorin calcium, and irinotecan hydrochloride, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Giving more than one drug~     (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as~     panitumumab, may block tumor growth in different ways by targeting certain cells. Giving~     FOLFIRI together with panitumumab may be an effective treatment for colorectal cancer.~   "
80895|NCT02508064|"~     This 2-part study will determine the bioavailability of BMS-626529 in healthy subjects from~     prototype low dose extended release formulations (Part 1) of BMS-663068 and prototype~     extended release multi-particulate formulations (Part 2) of BMS-663068 relative to 600 mg~     extended release tablet of BMS-663068.~   "
80896|NCT02508051|"~     Optimal patient care hinges on physicians remaining up to date with developing medical~     knowledge. With ever increasing clinical demands however, the ability of physicians to do~     this is compromised. While the structure of journal based reports requires the devotion of~     significant time to glean emerging medical findings, social media can grab an individual's~     attention and then direct them to external media sites, so as to obtain more specific and~     detailed information of emerging medical findings. If medical journals were to fully embrace~     social media, physicians would have a more time-cost effective means for staying up to date.~      Specific aims Using the investigator's experience as editors of two medical education based~     blogs, the Specific Aims of this project is to determine if a combined journal and social~     media-based education strategy will be more likely to continuously engage physicians. The~     investigators will specifically test whether physicians who access a medical journal blog~     will have better knowledge of the information contained in a journal, measured by CME-based~     questions of journal articles than they would if they only received links to the journal's~     site.~      Specifically, the investigators will randomize participants into 3 groups with all~     interventions done by e-mail: group 1 is the usual care group, and will receive no~     intervention except for a reminder every six months to take a test of journal-based~     Continuing Medical Education (CME) questions from 2 anesthesiology journals; group 2 will get~     e-mailed web links to different specific articles, including articles on which the CME~     questions are based, published in 2 anesthesiology journals Monday through Friday with a~     reminder to take the same test every six months; and group 3 will get e-mailed web links to~     blogs Monday through Friday based on the same specific articles as in group 2; each daily~     blog will focus on a specific article, including articles on which CME questions are based,~     the blogs will have web links to the articles on which they are based and every six months~     group 3 will get a reminder to take the same test. This will continue for 2 years' duration.~     Every six months, the investigators will assess knowledge of material contained in the two~     journals using CME material from the journals.~      The investigators hypothesize that those participants randomized to group 3, the group that~     will receive web links to blogs, will stay more informed, as measured by the test score of~     CME-based questions. The investigators expect that both groups 1, usual care, and 2, e-mailed~     links to articles, will have a similar low score as the investigators found in a preliminary~     study of anesthesiologists who were presented with a set of journal-based CME questions.~      Public Health Significance. This study will demonstrate the utility of journal based blogs as~     a support to physicians in their effort to remain up to date with developing medical~     knowledge.~   "
80897|NCT02508038|"~     This phase I trial studies the safety of transplantation with a haploidentical donor~     peripheral blood stem cell graft depleted of TCRαβ+ cells and CD19+ cells in conjunction with~     the immunomodulating drug, Zoledronate, given in the post-transplant period to treat~     pediatric patients with relapsed or refractory hematologic malignancies or high risk solid~     tumors.~   "
80898|NCT02508025|"~     Purposes of this research:~        -  To study similarities and differences in FCE performances between participants from~          different countries, jurisdictions, and evaluators.~        -  To study determinants of FCE performance.~   "
80899|NCT02508012|"~     Since their appearance more than a decade ago, anti-tumor necrosis factor (TNF) inhibitors~     have demonstrated beneficial activity in the treatment of inflammatory bowel diseases (IBD).~     However, more than one-third of patients present primary resistance, and one more third~     become resistant over time. One of the main factors associated with loss of response is the~     immunogenicity of anti-TNF biologics leading to the production of antibodies targetting the~     TNF inhibitor, namely anti-drug antibodies (ADAbs), that accelerate drug elimination from the~     serum and decrease its therapeutic activity. In this study the investigators propose a~     medico-economic evaluation of the mesurement of anti-TNF agents and anti-drug antibodies~     serum concentrations in the management of patients with inflammatory bowel disease treated~     with anti-TNFalpha inhibitors. 280 patients with Crohn's disease (CD) or ulcerative colitis~     (UC) will be included and randomized in 2 groups with or without drug and ADAbs monitoring.~     In the monitored group, in case of loss of response, the clinician will use biological~     informations to adapt the treatment following a simple treatment algorithm. In the~     unmonitored group, drug and ADAbs measurements will not be transmitted to the clinician.~     Clinical and economical benefits of the biological monitoring will be evaluated after a~     follow-up period of two years.~   "
80900|NCT02507999|"~     Goal directed therapy (GDT) is a technique, which employs a non-invasive cardiac output~     monitoring (NICOM) device to guide management of circulating blood volume and blood pressure~     during procedures. The purpose of this study is to determine whether the use of goal-directed~     therapy to optimize blood volume and cardiac output during the procedure can improve the~     outcome of patients undergoing endovascular treatment of a brain aneurysm.~   "
80901|NCT02507986|"~     The main objective of this study is to compare the incidence of detected atrial fibrillation~     (AF) in cryptogenic stroke patients by a single lead ECG device with the incidence of~     detected AF by a 7-Day Holter ECG.~   "
80902|NCT02507973|"~     The investigators will conduct an observational crossover study. The investigators aim to~     recruit 50 participants with severe Traumatic Brain Injury (TBI) requiring intracranial~     pressure (ICP) monitoring during their stay at the Neuro Trauma ICU at the R Adams Cowley~     Shock Trauma Center.~      Overall, participants will be monitored, on average, for approximately 6-8 hours during the~     study period. The investigators do not anticipate the need for prolonged monitoring during~     the duration of their hospital stay or post hospital period.~   "
80933|NCT02507570|"~     This is an open label study designed to examine the effects of Enzalutamide with concurrent~     administration of Radium Ra 223 dichloride in Castrate-Resistant (Hormone-Refractory)~     Prostate Cancer subjects with symptomatic bone metastases in both the pre- and~     post-chemotherapy setting.~   "
80903|NCT02507960|"~     In this study, investigators plan to deliver a 8 Gy Tumor Bed (TB) boost using the Gamma Pod™~     system followed by a conventional (50Gy in 25 fractions) or hypofractionated (40Gy in 15~     fractions) course of whole breast radiation. The clinical target volume receiving 8 Gy will~     be the surgical cavity as defined by the surgical clips and post-surgical changes + 5 mm. The~     planning target volume (PTV) will add 5 mm to the clinical target volume to account for~     geometric uncertainties.~   "
80904|NCT02507947|"~     SPECTAmel is a standardized, quality-assured molecular screening platform for tumor~     characterization and storage of human biological material (HBM) for the purpose of~     integrating new biomarkers into clinical trials and optimizing access of patients to~     therapeutic biomarker-driven clinical trials. HBM and clinical/pathological data are~     collected from consenting patients.~   "
80905|NCT02507934|"~     Dry eye is a multifactorial disease of the tears and ocular surface that results in symptoms~     of discomfort, visual disturbance, and tear film instability with potential damage to the~     ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation~     of the ocular surface.~      Lubricin is a mucin-like glycoprotein originally discovered in synovial fluid, as a secreted~     product of cells that line the joint tissues, which is present at the surface of articular~     cartilage and it has been investigated on its roles at the ocular surface, in normal and~     pathologic conditions such as dry eye.~      The objective of the study is to assess the tolerability, safety and efficacy of Lubricin eye~     drops solution administered over 4 weeks versus sodium hyaluronate (Na-HY) eye drops solution~     in subjects with moderate dry eye.~   "
80906|NCT02507921|"~     The investigators aim to assess type and frequency of HIV drug resistance in adults~     presenting to the Infectious Diseases Institute (IDI) in Kampala, Uganda, and compare this~     data to patients from the Swiss HIV Cohort Study (SHCS). This study is a single-site,~     cross-sectional study. The Investigators' goal is to perform viral load measurements in 2750~     HIV-infected patients who have been on ART for 6 months or more. Presuming a detectable viral~     load in 10%, resistance testing would then be performed in 250 patients on ART. All adult~     patients attending will be screened for enrollment. Furthermore, the investigators' goal is~     to perform resistance testing in 250 ART naive patients in order to detect transmitted~     resistance mutations. Investigators will therefore consecutively screen and enroll 250 ART~     naive patients who attend the clinic during the study period. For each participant, a case~     report form (CRF) form will be completed which includes social, as well as medical~     information. Investigators will ask each participant for permission to store plasma in case~     resistance testing must be repeated, and serum, in case of future research questions.~   "
80907|NCT02507908|"~     The objective of this observational laboratory study is to measure the correlation between~     5-hydroxyindolacetic acid (5-HIAA) in platelet rich plasma and 5-HIAA in 24-hours urine~     collection in adult patients with a serotonin-producing neuro-endocrine tumor. Plasma and~     urine of included patients are collected and 5-HIAA values are measured with LCMS-MS and~     analysed.~   "
80908|NCT02507895|"~     Currently the process for stroke recovery is slow with majority of its treatments focused~     around physical therapy. Among the many methods employed to facilitate recovery in stroke,~     the use of motor imagery (MI) training may be beneficial towards stroke rehabilitation.~      In the current study, we propose 2 aims. Our first aim is to determine the feasibility and~     efficacy of a novel brain-computer interface-assisted MI train program (BCI-MI) in patients~     with chronic ischemic stroke. This is designed as a proof-of-concept study that only require~     a single-session trial. If patients successfully activate the BCI-MI system without much~     difficulty, our second aim is to enroll patients into a 4-week training program using the~     BCI-MI. Both functional magnetic resonance imaging (fMRI) and transcranial magnetic~     stimulation (TMS) will be done to determine the effects of the 4-week training program.~     Subjects may potentially see improvements in walking gait as preliminary data from previous~     studies have demonstrated positive results.~   "
80909|NCT02507882|"~     Hepatocellular carcinoma (HCC) is the third leading cause of cancer deaths worldwide as well~     as in Egypt. Despite improvements in HCC therapy, the prognosis for HCC patients remains~     poor. Today molecular, genomic and epigenomic aberrations in tumors are being deeply~     investigated. Many biomarkers were associated to HCC onset, and they could be useful for~     clinicians, but all show some limitations and no one is so early to predict the HCC onset.~      It is estimated that 51.5% of HCC cases can be attributed to HCV infection. Moreover, there~     is a large occult reservoir of HCV caused chronic liver disease in approximately 9 % in the~     Egyptian with estimated 6 million HCV chronic infections and estimated 150 000 new infections~     per year. Among them, we have to mention the polymorphism of IL28B gene rs12979860 C/T. and~     rs 4803217. The IL-28B gene encodes interferon-lambda 3 (IFN-λ3), which belongs to the type~     III IFN family. IFN-λ interacts with a transmembrane receptor inducing a potent antiviral~     response. In experimental model of HCV type III IFN was able to inhibit viral replication.~     IL-28B polymorphisms are linked to the efficiency of the inflammatory process during HCV~     infection, and to the mechanisms that HCV adopts to escape by innate and adaptive immunity.~      During the last years, a number of studies have assessed the association between the IL-28B~     polymorphisms and risk of HCC and liver cirrhosis (LC) occurrence in various populations;~     however, results obtained are still inconclusive.~      Interestingly, some polymorphisms located at the 3' untranslated region (UTR) of IL28B, e.g.~     rs 4803217, seem to interfere with the binding of miRNA, to date recognized as important~     post-transcriptional regulators. In the last years miRNAs acquired a growing relevance as~     potential biomarkers for several diseases including cancer, and many researches are focusing~     on understanding their role in cancer.~      Thus the objectives of the current proposal are to determine through investigating a cohort~     of 405 patients, whether IL28B rs12979860 and rs4803217 polymorphisms are associated to the~     risk of HCC in chronic hepatitis C (CHC) patients and, above all, to identify their role as~     predictor marker of HCC in CHC, when associated to miRNAs modulation. Data obtained by our~     work could be helpful in HCC diagnosis, thus leading to the improvement of the patients~     prognosis. The proposed activities are going to be implemented through a partnership us as~     Egyptian Liver Research Institute and Hospital (ELRIAH)- Dakhlya- Egypt and Non- Egyptian~     Partners.~   "
80910|NCT02507869|"~     Despite awareness of the benefits of engaging in regular physical activity, at least 50% of~     adults in the US do not meet recommended guidelines for physical activity. One potential~     explanation for this lack of regular physical activity is that people often experience~     exercise as affectively unpleasant. Evidence suggests that the more positively people~     experience exercise (i.e., the better they feel while exercising), the more likely they are~     to engage in regular physical activity. This may be especially true for people in poor~     cardiorespiratory condition. In this randomized trial, investigators compared the effects of~     an affect-guided exercise prescription (intervention) to a heart rate-guided exercise~     prescription (control) on change in physical activity minutes among previously underactive~     adults. Investigators also tested whether the effect of the intervention was moderated by~     differences in cardiorespiratory fitness.~   "
80911|NCT02507856|"~     The multi-center, prospective PRODAST study is investigating patients with non-valvular~     atrial fibrillation (AF) who experienced an ischemic stroke or a transient ischemic attack~     (TIA) recently (≤ 1 week) both with and without previous oral anticoagulation. It consists of~     a baseline visit and a 3 months central follow-up for patients who were discharged with~     dabigatran, vitamin K-antagonists, antiplatelets only, or no oral antithrombotic treatment at~     all. Thus, data on the use of dabigatran and vitamin K-antagonists in routine clinical~     practice will be collected to describe how dabigatran is prescribed and used in the~     population of AF patients with recent cerebrovascular events and how these factors influence~     important outcome and safety events. The utilization of dabigatran will be assessed with~     regards to treatment persistence, compliance, proportion of patients discontinuing treatment~     and reason for discontinuation as well clinical endpoints such as major bleeding, stroke or~     systemic embolism. Due to the fact that patients will be treated according to local medical~     practice it is possible that medication will be changed during the observation period. In the~     follow-up, data from the first as well as from the second prescribed medication will be used~     in the study. To explore a long-term effect of anticoagulation, survival up to one year will~     be assessed.~   "
80912|NCT02507843|"~     This study evaluates vitamin D as an adjunctive treatment in patients with non-Cystic~     Fibrosis bronchiectasis, which are combined with vitamin D deficiency. Half of participants~     will receive vitamin D supplementation, while the other half will receive placebo.~   "
80913|NCT02507830|"~     Prospective observational study with mesh fixation using FDA approved synthetic glue,glubran~     2 and standard mesh fixation with stiches in primary inguinal hernia repair surgery. The~     investigators aim is to recruit 150 patients for the study.~      The outcomes The investigators would like to determine are : postoperative pain,recurrences~     and complication rates such as seromas.~   "
80914|NCT02507817|"~     During embryonic development, there are several cytokines such as: LIF (Leukemia inhibitory~     factor), ciliary neurotrophic factor (CNTF), epidermal growth factor family (EGF), neuregulin~     1 (NRG1) and transforming growth factor β (TGFβ) that were found are associated with~     neurogenesis and differentiation of brain cells.~      LIF is a cytokine that is essential for the development of the central nervous system, and~     has recently been shown in rats that maternal LIF stimulates placental ACTH~     (adrenocorticotropic hormone) that in turn promotes secretion of fetal LIF from nRBC~     (nucleated red blood cell ), which in turn promotes brain development of the fetus In other~     studies on rats a theory was proposed that LPS (lipopolysaccharide) and infection during~     pregnancy influence the normal development of the brain and may cause brain damage by~     altering placental ACTH thank in turn alters LIF secretion in the embryo which could be the~     cause of brain damage.~      Our hypothesis is that by treating the mother with Magnesium Sulphate we can protect the~     embryo's brain in one of two ways:~        1. Altering Placental ACTH~        2. Altering the number of receptors for LIF in the brain Women who are at risk for preterm~          labor prior to 32 weeks of gestation are treated with Magnesium Sulphate for~          neuroprotection, randomized controlled studies showed that if these women are treated in~          the 24 hours prior to labor with magnesium sulphate the risk for cerebral palsy and~          other severe motor problems are decreased.~      The mechanism for this decrease is unknown and that is the purpose of our study.~      The purpose of our research is to examine maternal LIF levels prior to birth and Maternal and~     cord levels after delivery and to see if levels are different if the mother was treated with~     Magnesium Sulphate. We will also check the placental ACTH level~   "
80915|NCT02507804|"~     The aim of the study is to design and evaluate a PROMs diary for cancer patients to self~     report side effects and experiences of their treatment, and thereby create a detailed account~     of treatment related adverse events and their impact on daily activities to share with the~     care team.~   "
80916|NCT02507791|"~     This study is evaluating the feasibility and efficacy of using Fitbit Charge HR devices to~     remotely track the physical activity of obese pediatric patients who are concurrently~     enrolled in a comprehensive weight loss intervention program. Patients will receive Fitbit~     devices and will be called weekly to review their average daily steps and heart rates.~     Patients will receive the Fitbit either at the beginning of classes or upon completion of~     classes. Patients will then be followed remotely and called weekly for 12 additional weeks~     after completing classes. The two groups will be compared to examine for differences.~   "
80917|NCT02507778|"~     The aim of this study is to quantify the spillage of tumor cells after biopsy in early lung~     cancer.~   "
80918|NCT02507765|"~     This pilot clinical trial studies stereotactic body radiation therapy (SBRT) and~     transarterial chemoembolization (TACE) in treating patients with liver cancer that cannot be~     removed by surgery. SBRT is a specialized radiation therapy that delivers a high dose of~     radiation directly to the tumor and may kill more tumor cells and cause less damage to normal~     tissue. Chemoembolization kills tumor cells by carrying drugs directly into blood vessels~     near the tumors and then blocking the blood flow to allow a higher concentration of the drug~     to reach the tumor for a longer period of time. SBRT may make TACE more beneficial by~     increasing blood flow to the tumor, which may allow more of the TACE chemotherapy to enter~     the tumor. Giving SBRT with TACE may work better in treating patients with liver cancer that~     cannot be removed by surgery.~   "
80919|NCT02507752|"~     This multicenter prospective observational study will evaluate the quality of life in~     participants with rheumatoid arthritis (RA) who are initiated with rituximab~     (MabThera/Rituxan). Participants will be followed for 6 months from initiation of treatment.~   "
80920|NCT02507739|"~     Mobilization, ambulation, during obstetrical work attitudes are naturally adopted by women~     since ancient times in many countries. The advent of the epidural in the 60s revolutionized~     the management of pain during childbirth. The consideration of such advance is to keep the~     laboring parturients lying down. Indeed at this time the use of high doses of local~     anesthetics charge of an engine block against formally allocate all up.~      In a matchless analgesic efficacy during childbirth, epidurals also offers the possibility of~     a secure obstetrical gesture because without general anesthesia, inhalation great purveyor in~     these women with full stomach. These advantages explain the considerable growth in the number~     of epidurals performed in obstetric work in France over the last thirty years. However, this~     analgesia technique will soon be implicated in the alterations of obstetric mechanics, its~     effects depend primarily on the nature and concentration of the products used.~      Evolution is then marked by a considerable reduction of concentrations of local anesthetics~     used with the addition of opioids, allowing to achieve an isolated analgesia without~     impairing motor skills, it involves the lower limbs or muscles pelvis, allowing the woman to~     mobilize.~      Ambulatory epidural and made its appearance in the early 90. Responding to women in labor~     demand wishing to receive effective labor analgesia without being confined to bed, she then~     puts to the test the dogmas and practices on how to provide analgesia that is both effective~     and safe. It is now well codified and used daily in some maternity hospitals.~      The mobilization of women during labor is a subject that motivates obstetric teams Caen~     University Hospital for many years. Motherhood has thus given the means for monitoring and~     ambulatory epidural analgesia protocol suitable for this technique.~      The introduction of this daily care protocol opens new possibilities of care delivery hoped~     more physiological and less iatrogenic.~      A critical evaluation of the changes possibly recorded on obstetric mechanics inherent~     question, motivating, for which the answers are now few and discordant in the literature.~      The investigators therefore propose a randomized study evaluating single-center relative to~     obstetrical work typically occurring in a bed, the mobilizations of repercussions out of bed,~     in terms of obstetrical mechanics and comfort of the parturient.~      Those will be objectified by a significant change in the working hours. This study included~     560 patients is scheduled to last 2 years. Positive effects could also have repercussions in~     terms of public health and even of health economics.~   "
80922|NCT02507713|"~     Amyotrophic Lateral Sclerosis (ALS) is a progressive and fatal neurological disease.~     Nonspecific symptoms lead to a delay in the diagnosis, only confirmed by the~     electrophysiologic study.~      Objectives.~        1. To establish the diagnostic value of ultrasonography in ALS.~        2. To evaluate the rate of muscle and nerve degeneration by ultrasonography in patients~          with ALS.~        3. To check the relationship between ultrasound, clinical variables and functional tests in~          patients with ALS.~      Methods. A longitudinal observational study in a consecutive sample of patients diagnosed~     with ALS will be realized. All the patients will be examined 3 times during 6 months and~     capabilities associated with ALS and muscle strength will be assessed. Bilateral and cross~     sectional ultrasonography of several muscles and also median and tibial nerves will be~     performed. All the images will be processed and analyzed for obtaining morphometric variables~     (muscle thickness and nerve area) and textural ones (echogenic variation, entropy,~     homogeneity, textural contrast and correlation). Frequency of twitches will be also recorded.~     After longitudinal study, a survival study will be performed in relation to functional and~     sonographic variables.~   "
80923|NCT02507700|"~     Popliteal block is a technique for providing postoperative pain management in children. In~     this randomized double-blinded study, the investigators evaluated the effects of preoperative~     popliteal nerve block on postoperative pain and analgesic requirement in children with~     cerebral palsy (CP) undergoing knee-anckle soft tissue surgery. The Wong Baker faces scale~     and skin conductance fluctuations will be assessed.~   "
80924|NCT02507687|"~     This study will evaluate the intraocular pressure-lowering effect and safety of Bimatoprost~     SR compared with selective laser trabeculoplasty in patients with open-angle glaucoma or~     ocular hypertension who are not adequately managed with topical IOP-lowering medication.~   "
80925|NCT02507674|"~     1. Purpose and Objective: The purpose of this study is to test the feasibility of rapid~          acquisition of point of care 3D ultrasound for pediatric appendicitis. The study will~          use a newly developed acquisition method and post-processing technique to create three~          dimensional image models of the abdomen.~        2. Study activities and population group. The study population will be a convenience sample~          of patients 18 years and younger with suspected appendicitis, whose clinical care~          (unrelated to the study) includes ultrasound and/or CT of the abdomen. The study~          intervention includes acquisition of research ultrasound images, which will not be used~          for clinical care, and comparison of these images with clinically obtained images. Other~          clinical data such as surgical and pathology reports will also be reviewed. If not~          evident from the patient medical record, the final diagnosis will be confirmed by a~          telephone call to the subject 2 weeks after the initial visit.~        3. Data analysis and risk/safety issues. This is a pilot study intended to determine~          feasibility and to refine image reconstruction algorithms. Research images will be~          compared to clinical images to determine the frequency of visualization of the appendix~          and whether the appendix was deemed normal or abnormal. Comparison of research images~          with final diagnosis will also occur. The research intervention, an ultrasound exam, has~          no known safety risks. The only risk to subjects is loss of confidentiality.~      This study is observational, not interventional, because the experimental ultrasound will be~     performed in all subjects and will not be used in the clinical care of patients~     (consequently, will not have the opportunity to affect clinical outcomes). Experimental~     images will be reviewed after completion of clinical care and will not be provided to the~     clinicians caring for the subjects. We are not measuring the effect of the ultrasound~     examination on the subjects' outcomes.~   "
80926|NCT02507661|"~     The purpose of this study is to evaluate esthetic outcome of implant supported single crowns~     after alveolar ridge preservation with beta three calcium phosphate with collagen type I in~     aesthetic region in upper jaw.~   "
80927|NCT02507648|"~     Comparative randomized, single dose, two-way crossover open-label study to determine the~     bioequivalence of Oseltamivir from Oseltamivir 75 mg capsules (Pharmacare PLC, Palestine) and~     Tamiflu® 75 mg capsules (Hoffmann-La Roche, Switzerland under license Gilead Sciences~     ,California ,USA after a single oral dose administration of each to healthy adults under~     fasting conditions.~   "
80928|NCT02507635|"~     The main purpose of the treatment of persistent allergic rhinitis is to improve symptoms and~     patients' quality of life and prevent the development of asthma. Therapeutic strategies also~     target a reduction of pro-inflammatory mediators released from activated cells, including~     mast cells and epithelial cells. The presence of allergic inflammation in nasal mucosa may~     increase the risk of asthma occurrence, especially in patients with persistent allergic~     rhinitis. H1 antihistamines are widely recommended in all types of allergic rhinitis,~     regardless of symptom severity or persistence. They control all of the symptoms, but to a~     lesser extent nasal congestion. New generation agents, such as levocetirizine and~     desloratadine, possess anti-inflammatory properties, reducing allergic inflammation.~   "
80929|NCT02507622|"~     The main goal of the study is demonstrate that e-Nose system function is not altered in~     weightlessness and more specifically that gas concentration measurements are the same in~     weightlessness and normal gravity.~   "
80930|NCT02507609|"~     The purpose of the study is to determine the relationship between the degree of neuromuscular~     block, the release of cytokines and clinical outcomes in elderly patients undergoing~     orthopedic surgery. Investigators hypothesize that deep neuromuscular blockade decreases the~     release of cytokine and the incidence of postoperative delirium in elderly patients~     undergoing orthopedic surgery, compared with moderate neuromuscular blockade.~   "
80931|NCT02507596|"~     A clinical and radiographic evaluation of Nano-crystalline hydroxyapatite silica gel in~     comparison with open flap debridement for management of periodontal intrabony defects.~   "
80932|NCT02507583|"~     This human Phase 1 trial is a continuation of a Phase 1 trial which enrolled patients with~     recurrent gliomas (#TJU-14379-101) and which was designed after a previously conducted Phase~     1 human trial at our institution. With certain modifications, it is intended to reproduce the~     safety results of the recurrent glioma previous trials as well as explore any objective~     clinical responses in newly diagnosed patients. Protocol 14379-101 is closed to accrual and~     Abbreviated Clinical Report is prepared for FDA submission. The safety profile for this~     protocol was quite favorable.~      This treatment involves taking the patient's own tumor cells at surgery, treating them with~     an investigational new drug (an antisense molecule) designed to shut down a targeted surface~     receptor protein, and re-implanting the cells, now encapsulated in small diffusion chambers~     the size of a nickel in the patient's abdomen within 24 hours after the surgery. Loss of the~     surface receptor causes the tumor cells to die in a process called apoptosis. As the tumor~     cells die, they release small particles called exosomes, each full of tumor antigens. The~     investigators believe that these exosomes as well as the presence of the antisense molecule~     work together to activate the immune system against the tumor as they slowly diffuse out of~     the chamber. Immune cells are immediately available for activation outside of the chamber~     because a wound was created to implant these tumor cells and a foreign body (the chamber) is~     present in the wound. In this trial, a dose escalation of the therapeutic agent will involve~     an increase in both biodiffusion chamber number as well as the time the biodiffusion chambers~     remain implanted. The wound and the chamber fortify the initial immune response which~     eventually leads to the activation of immune system T cells that attack and eliminate the~     tumor. By training the immune system to recognize the tumor, the patient is also protected~     through immune surveillance from later tumor growth should the tumor recur. Compared to~     treatment alternatives for tumor recurrence, including a boost of further radiation and more~     chemotherapy, this treatment represents potentially greater benefit with fewer risks.~   "
80934|NCT02507557|"~     Excessive fluid loss is often reported in gastrointestinal surgical patients due to~     preoperative fasting and bowel preparations. Insufficient fluid infusion may cause~     hypovolemia and tissue hypoperfusion, which may delayed postoperative recovery and even~     induce postoperative acute renal failure. The aim of this study is to compare the effects of~     Goal-directed fluid therapy (GDFT) strategy with that of the conventional fluid management on~     the morbidity and mortality of postoperative complications, length of postoperative hospital~     stay, and medical expense, so as to provide clinical evidences for optimized intraoperative~     fluid management for patients undergone gastrointestinal surgery.~   "
80935|NCT02507544|"~     TRX-818 is a new small molecule chemical entity being developed as a potential anti-cancer~     therapeutic by TaiRx, Inc. TRX-818 is a potent anti-cancer agent in numerous human cancer~     cell lines. The objectives of this study are to determine the safety profile of TRX-818~     including identification of dose limiting toxicity (DLT) and maximum tolerated dose (MTD) and~     determine the recommended dose and regimen(s) to initiate Phase 2.~   "
80936|NCT02507518|"~     Non small cell lung cancer is the first cause of cancer related death in France and is~     becoming an increasing health problem in developing countries.~      Recently for patient with no progression disease after first line chemotherapy, new therapies~     were validated in maintenance (bevacizumab) or switch maintenance treatment (erlotinib,~     pemetrexed) with improved survival.~      Until now, determination of efficiency of treatment is only based on morphological response~     (RECIST) and remains inappropriate to such cytostatic drugs for which there is no anatomical~     lesion modification.~      Nuclear Medicine and especially 18-FDG Positron Emission Tomography (PET) offers a~     biologically relevant tool for assessment of tumour response therapies.~      The assumption of the study is that FDG PET would allow to earlier detect a lack of response,~     thereafter, to modify an ineffective treatment. Indeed, nowadays the treatment is maintained~     up to evidence of progression disease.~      However, despite the increasing use of FDG PET for predicting therapeutic response, there are~     no validated criteria for judging response of maintenance therapy in non-small cell lung~     cancer.~      It seems necessary to determine standardized criteria response, earlier during the course of~     maintenance therapy in patient with non small cell lung cancer.~      The final aim is to optimize survival by an adapted metabolic imaging guided therapy.~   "
80937|NCT02507505|"~     The purpose of this study is to find out if two types of standard care anesthesia are the~     same or if one is better for people who have hip fractures.~   "
80938|NCT02507492|"~     The purpose of this study is to evaluate the effects of a once daily subcutaneous (SC)~     injection of RM-493, in subjects with POMC (propiomelanocortin) or other related rare genetic~     mutations, on body weight, metabolic function and blood pressure. Patients who respond during~     the initial 84 days of treatment can enter into long-term (2-year) extensions. The study drug~     (RM-493) will be administered in an unblinded fashion.~   "
80939|NCT02507479|"~     The study hypotheses is that the introduction of dose escalated thiotepa, in substitution to~     busulfan or melphalan, will reduce toxicity after allogeneic transplantation while improving~     disease eradication in patients with lymphoid malignancies not eligible for standard~     transplantation.~   "
80940|NCT02507466|"~     The overall objective of this subproject is to evaluate the individual and paired~     contributions of intensity and variability of stepping training on lower extremity (LE)~     function, health and community participation in patients with chronic hemiparesis~     post-stroke.~   "
80941|NCT02507453|"~     Parabolic flight is the only ground-based condition in which free-fall (0G) can be created~     long enough for safely testing changes in human perception and behavior. In addition to the~     0G period, parabolic flight generates equal duration periods of 1.8G, which present another~     unique opportunity to test the same responses to hypergravity and back to 1G.~      It is well known that performance decrements occur in astronauts during and after gravity~     level transitions. Illusions are commonly felt in orbit as well disorientation and perceptual~     limitations, mainly due to both psycho-physiological changes and adaptation and lack of~     familiar points of reference in the space environment. Studies performed during previous~     space missions showed several changes occurring in different gravity conditions, pointing~     out, for example, that colors and shadows were misleading, the depth and distance perception~     were weakened, and the linear perspective was lost. Visual perception is of primary~     importance for spatial orientation and object recognition because the static vestibular~     (otolithic) and proprioceptive signals are absent when free-floating. Consequently,~     astronauts become increasingly dependent on vision to perceive motion and orientation. All~     these factors play an important role in the adaptation of humans to spaceflight that needs to~     be analyzed to understand the underlying mechanisms that regulate human psycho-physiological~     adaptive process to changing gravity. Human psycho-physiological health has to be safeguarded~     and possibly improved when long-term human space missions are programmed in the near future.~      The primary objective of this experiment is to investigate if the SWI illusion is present in~     altered gravity environments. Since weight cannot be estimated in 0G, investigators have~     developed a procedure during which the subject is asked to estimate the objects' mass by~     shaking them rather than lifting them. Our results in 1G indicate that a size-mass illusion~     (SMI) is also present in 1G. Our hypothesis is that the previously observed alteration in 3D~     visual perception in 0G, particularly in the height of 3D objects, as well as the change in~     proprioceptive inputs, will be responsible for changes in the SMI in 0G and 1.8G compared to~     1G. In a separate proposal, investigators will also propose to perform this experiment using~     the ESA short-arm human centrifuge (SAHC), with subjects exposed to various centrifugal force~     levels, to further investigate the role of proprioceptive cues in the size-mass illusion.~   "
80942|NCT02507440|"~     To find out if the administration of the local pharyngeal anesthetic, lidocaine, in~     conjunction with Propofol during elective Esophagogastroduodenoscopy (EGD) is useful, safe~     and impacts the time of discharge of patient compared to placebo.~   "
80943|NCT02507427|"~     To evaluate the safety and efficacy of pelvic autonomic nerve monitoring and mapping during~     robot assisted laparoscopic radical prostatectomy for preservation of erectile function.~   "
80944|NCT02507414|"~     It is the hypothesis of this project that the Mesenteric Traction Syndrome (MTS) is a common~     event during upper gastrointestinal cancer surgery (UGC surgery) and that the induction of~     the syndrome is an important factor in provoking further peri- and postoperative~     complications and in worsening the surgical stress response (SSR). The characteristics of MTS~     is hypotension, tachycardia, and flushing.~      In order to uncover the role of MTS in cancer surgery and the effects on the oncological~     patients, the aim of the project is:~      1. To characterize MTS in patients undergoing three common forms of UGC surgery using a new~     objective methodology and by recording biomarkers suspected of playing a role in the~     pathophysiology of MTS and postoperative complication development.~      Three different interventions will be examined during this prospective trial:~        1. Continuous measurement of microcirculation on the forehead using Laser Speckle Contrast~          Imaging during surgery.~        2. Analyses of plasma samples obtained pre-, intra-, and one day postoperatively.~        3. Continuous measurements of haemodynamic variables during surgery.~   "
80945|NCT02507401|"~     The purpose of this study is to determine whether the mix of microbial species isolated from~     biofilm-clogged voice prostheses is specific to each participant, whether the microbes are~     orally-derived and whether the presence of specific species is a predictor of the frequency~     with which patients discard devices due to malfunction. The microbes isolated from discarded~     devices will be used to test the antimicrobial properties of newly-developed medical~     silicones.~   "
80946|NCT02507388|"~     The purpose of this study is to assess the systemic pharmacokinetics (PK) and safety of 2~     different doses of brolucizumab (3 milligrams (mg)/50 microliters (μL) and 6 mg/50 μL) when~     administered at 4-week intervals for a total of 3 intravitreal injections in subjects with~     neovascular age-related macular degeneration (AMD).~   "
80947|NCT02507375|"~     This study will assess the safety and tolerability, and make a preliminary assessment of~     activity, of a combination of pertuzumab and erlotinib in patients with locally advanced or~     metastatic non-small cell lung cancer (NSCLC) who have failed on at least one prior~     chemotherapy regimen. The anticipated time on study treatment is until disease progression or~     unacceptable toxicity, and the target sample size is less than 100 individuals.~   "
80948|NCT02507362|"~     the purpose of this study is to compare the efficacy and safety of a new method of corneal~     cross-linking that uses UV-A irradiation intensity of 9mW/cm2 for 7 minutes to well-known~     Accelerated corneal cross-linking (9 mW/cm2 UV-A irradiation for 10 minutes)~   "
80949|NCT02507349|"~     Fifteen minutes is the typical length of an outpatient medication management appointment for~     people with serious mental health conditions. These brief interactions with prescribers are~     frequently provider-driven with insufficient time focused on the patient's needs and personal~     recovery. Shared decision making is a strategy that could improve this interaction. This~     study examines how technology can be used in the care process to amplify the voice of the~     patient, support shared decisions, and improve treatment outcomes.~      Investigators will compare the effectiveness of Measurement-Based vs. Person-Centered Care on~     two primary patient-centered outcomes: the patient experience of care with medication~     treatment and the level of shared decision making. Investigators hypothesize that:~        1. Person-Centered Care will result in greater improvement in patient experience of care~          with medication treatment than Measurement-Based Care.~        2. Person-Centered Care will result in a greater level of shared decision making during the~          medication visit than Measurement-Based Care.~      The study team will collect information from patients, caregivers, and clinic staff at~     different points in time during the study. Patients will be asked to complete questionnaires,~     and additional data on their service use will be gathered. Some patients and providers will~     also be interviewed about their experiences with care. Investigators are especially~     interested to learn if and how these two approaches are perceived to change medication~     treatment, if patients are more satisfied and empowered in their care, and why and how~     providers perceive and adopt changes to their clinical care.~   "
80950|NCT02507336|"~     The study seeks to provide long-term follow-up and/or to offer continued maintenance~     thalidomide (THALOMID) therapy to those patients enrolled in 20030165. Patients will be~     followed until withdrawal of consent, or death.~   "
80951|NCT02507323|"~     This study has been designed as a randomized, double-blind trial to provide definitive~     evidence on the effects of ticagrelor and prasugrel on myocardial salvage in patients with~     anterior ST Segment Elevation Myocardial Infarction (STEMI) undergoing primary Percutaneous~     Coronary Intervention (PCI). This study will also measure the effects of ticagrelor vs.~     prasugrel on secondary endpoints listed above. This study design aims to test the hypothesis~     that ticagrelor will reduce myocardial infarct size as a proportion of the ischemic area at~     risk when compared to prasugrel.~   "
80952|NCT02507310|"~     Based on preliminary data and previous studies, we hypothesize that the ambient temperature~     experienced by an individual influences his or her food intake. Specifically, exposure to~     temperatures above the thermoneutral zone (TNZ) will decrease consumption in young adults in~     a sedentary situation. Researchers will execute a crossover randomized control trial~     specifically testing thermal exposure and its effect on individual female's food consumption.~   "
80953|NCT02507297|"~     The goal of this study is to understand the contribution of sleep-disordered breathing (SDB)~     to one of the most common and debilitating adverse pregnancy outcomes, perinatal depression.~     The study is a randomized trial to test the efficacy of positive airway pressure (PAP) on~     sleep and depression symptoms in perinatal women. Participants will be pregnant women with~     depression and sleep-disordered breathing. Participants will be randomly assigned to receive~     either PAP therapy (PAP group) or treatment as usual within obstetrics (TAU group). Mood and~     sleep assessments will be completed at baseline, after 1 week of enrollment, and monthly~     thereafter through 12 weeks postpartum. Cortisol will be measured using saliva collection at~     baseline and again 8 weeks later.~   "
80954|NCT02507284|"~     This study evaluates the tolerability, safety and activity of SRX246 in the treatment of~     irritability in patients with Huntington's disease. Two-thirds of all participants will~     receive SRX246, while the other third will receive a placebo.~   "
80955|NCT02507271|"~     The purpose of this project is to test the hypothesis that Speed of Information Processing~     (SIP) deficits in acquired brain injury (ABI) can be remediated. The majority of individuals~     with acquired brain injuries have speed of information processing deficits as part of the~     cognitive sequelae of the brain injury. Empirical research is expected to demonstrate the~     efficacy of computerized cognitive Speed of Information Processing (SIP) training in~     individuals with ABI.~      Study participants will be asked to attend two study visits over the course of approximately~     13 weeks. Participants will be randomly assigned to either the experimental or control group.~   "
80956|NCT02507258|"~     MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to~     evaluate the safety and efficacy of its total hip arthroplasty (THA) and resurfacing~     components marketed in the European Union (EU). These types of studies are required by~     regulatory authorities for all THA and resurfacing devices that do not have medium to~     long-term clinical evidence available at the time of gaining approval to market in the EU.~     This study has been designed in accordance with the medial device directives (MEDDEV) 2.12/2~     rev 2.~   "
81571|NCT02499237|"~     In contrast with bisphosphonates,discontinuation of denosumab results in gradual loss of bone~     mineral density gains. The investigators aim to evaluate whether in patients treated with~     denosumab, a single zoledronic acid infusion would prevent the anticipated bone loss.~   "
80957|NCT02507245|"~     The aim of this study is to assess the developmental patterns of lung function in children~     affected by growth hormone deficiency after one year of GH therapy.The assessment by specific~     questionnaires of quality of life and of parental stress index.Parameters will be evaluated~     at the time of the diagnosis and after 12 months of GH therapy.~   "
80958|NCT02507232|"~     The purpose of this study is to test the effectiveness and safety of the NovoTTF-200A device~     in patients with low-grade glioma when it's used by itself or used together with~     temozolomide. Researchers would also like to know whether the use of NovoTTF-200A, with or~     without temozolomide, is associated with fewer negative side effects on mental function that~     may be seen with other currently used treatment options.~   "
80959|NCT02507219|"~     The aim of this project is to determine whether the acute oral administration of Ibuprofen~     changes the activation pattern in the amygdala and other brain structures during functional~     magnetic resonance imaging. The investigators use a double-blind, randomized,~     repeated-measures design. Each of the 20 healthy control subjects will be tested three times~     and receive placebo, 200 mg or 600 mg dose of ibuprofen p.o. The study will consist of 4~     sessions: a baseline screening session and 3 testing sessions scheduled 1-2 weeks apart. Each~     of these individuals will undergo a multi-level assessment based on the RDoC approach that~     consists of (a) a standardized diagnostic assessment, (b) self-report questionnaires~     assessing the positive and negative valence domains as well as interoception, (c) behavioral~     tasks assessing reward-related processing, avoidance, and aversive processing, cognition, and~     interoception; (d) physiological measurements consisting of facial emotion expression~     monitoring, heart rate and respiration, (e) functional magnetic resonance imaging focusing on~     reward-related processing, fear conditioning and extinction, cognitive inhibition, and~     interoceptive processing, and (f) biomarker assessments.~   "
80960|NCT02507206|"~     The purpose of the study is to examine the effects of the administration of a drug called~     DAR-0100A on attention and memory in persons with schizotypal personality disorder (SPD).~     DAR-0100A has not been FDA approved, however in recent studies has been used to treat~     cognitive deficits, meaning problems in the way you organize your thinking, in people~     diagnosed with schizophrenia.~      Many people who carry a diagnosis of schizotypal personality disorder have trouble with~     attention and memory. Increasing the presence of a brain chemical called dopamine has been~     found to help people with schizophrenia with their attention and memory problems. This study~     will investigate whether the same is true for people with schizotypal personality disorder by~     using DAR-0100A, a drug that has been shown to help with the cognitive deficits of people~     with Parkinson's disease by increasing dopamine effects. Information collected in this~     experiment may lead to a better understanding of the brain mechanisms involved in schizotypal~     personality disorder and improve treatments for the psychological problems associated with~     this condition.~   "
80961|NCT02507193|"~     The primary objective of this study will be to evaluate the functional outcome of patients~     who present with a distal fibula fracture who were treated with either intermedullary nail~     (IMN) fixation or plate fixation.~   "
80962|NCT02507180|"~     This is prospective cohort study, in pregnant women who present with signs and symptoms of~     possible deep vein thrombosis. All patients will have the same method of assessment of their~     deep vein thrombosis (DVT) symptoms (the LEFt clinical decision rule will be applied and~     D-dimer test will be done) to determine if a compression ultrasound is required. All patients~     will be followed for a period of 3 months.~   "
80963|NCT02507167|"~     The purpose of this study is to evaluate the impact of genetic variants of OATP 1B3 or MRP 2~     on the systemic disposition of endogenously formed CCK-8 and to determine the influence of a~     single-dose of the transporter inhibitor rifampin (600 mg) on the systemic disposition of~     endogenously formed CCK-8. Endogenous CCK-8 secretion will be induced by a single-dose~     standardized liquid mixed meal.~   "
80964|NCT02507154|"~     This study aims to determine the safety and efficacy of expanded activated autologous NK~     cells administered after cetuximab in patients with EGFR-positive nasopharyngeal carcinoma or~     head and neck squamous cell carcinoma.~   "
80965|NCT02507141|"~     The purpose of this study is to get images (pictures) of oral lesions, which occur inside the~     mouth, before the patient's surgery using a special camera. These pictures will be used in~     our research to evaluate a new technology that uses a laser and takes pictures of the~     microscopic structure of tissue. The technology is called reflectance confocal microscopy.~     We would like to compare what the camera sees to biopsies (pathology) of the same area. We~     will evaluate the pictures obtained from the patient to determine whether this technology may~     be useful in the future. We hope this technology can be used as a tool for early diagnosis of~     oral cancers and for guiding surgery.~   "
80966|NCT02507128|"~     The investigators planned to evaluate the effects of liraglutide on no-reflow in patients~     with acute ST-segment elevation myocardial infarction (STEMI).~   "
80967|NCT02507115|"~     This project will develop an intervention delivered through text messaging to reduce alcohol~     consumption and high risk drinking among adults who are enrolled as students in community~     colleges.~   "
80968|NCT02507102|"~     This feasibility study will assess the effects of the Nativis Voyager therapy in patients~     with recurrent GBM who have either failed standard of care or are intolerant to therapy. The~     study will enroll and treat up to eleven subjects over six months. Safety and clinical~     utility will be evaluated.~   "
80969|NCT02507089|"~     This study aims to develop educational tools and platforms to promote the transfer of sleep~     health information to blacks to foster adoption of healthful sleep practices.~   "
80970|NCT02507076|"~     This pilot clinical trial studies isolated limb perfusion with melphalan in treating patients~     with stage IIIB-IV melanoma or sarcoma. Drugs used in chemotherapy, such as melphalan, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Heating a chemotherapy solution and infusing it directly into~     the arteries around the tumor may kill more tumor cells.~   "
80991|NCT02506803|"~     Gemcitabine plus nub-paclitaxel (GEMABR) regimen was recently presented at an international~     oncology meeting and represents a new standard regimen in the treatment of metastatic~     pancreatic cancer. Therefore, it was decided to consider the balance of safety and efficacy~     as a preoperative chemotherapy, the investigators use the NAC-GEMABR regimen includes only~     two cycles (three times weekly and one week rest) of GEMABR regimen.~   "
80971|NCT02507063|"~     The use of optic nerve sheath diameter (ONSD) measurements as a non invasive test for raised~     ICP has many potential benefits. This includes having assessments that can be made at the~     bedside instead of requiring patient transport to CT or MRI, which in itself can cause a rise~     in ICP. If ONSD represents an acute and sensitive measurement of elevated ICP, it may prove~     useful in the emergency department (ED) setting in the evaluation of shunts used for~     cerebrospinal fluid (CSF) diversion. The investigators hypothesize that ONSD will correlate~     with measured ICP and thus be a reliable tool for the bedside assessment of ICP. The~     investigators further hypothesize that ONSD changes will correlate with changes in ICP,~     making it a useful bedside tool for assessing ICP changes over time. This is a prospective,~     observational study using a convenience sample. Children who are 0 - 18 years old who have an~     invasive intracranial ICP monitoring device admitted to the hospital Pediatric Intensive Care~     Unit (PICU) are eligible for participation in the study. Children who are 0-18 years old who~     are determined to require a shunt revision following evaluation in the ED will also be~     included in the study. 10. After the invasive intracranial pressure monitoring device is~     placed, for every recruited patient, ONSD measurements will be taken and the ICP will be~     recorded 8 hours post placement and then repeated 3 times a day until the intracranial~     pressure monitoring device is removed.12. For ventriculoperitoneal (VP) shunt revision~     patients, the investigators will obtain a measurement just before surgery, immediately~     post-op, and then 12 hours, 24 hours, and 36 hours post-op. If the patient is otherwise ready~     for discharge prior to 36 hours, the measurement may be omitted or done early so as to not~     unnecessarily prolong the hospitalization~   "
80972|NCT02507050|"~     The aim of the study is to test whether, in patients with angina and flow limiting epicardial~     coronary artery disease, pre-treatment with Ivabradine, as opposed to beta blockers, will~     reduce post percutaneous coronary intervention induced microvascular dysfunction.~   "
80973|NCT02507037|"~     In this randomized controlled study, consecutive outpatients scheduled for elective~     colonoscopy were randomized into two groups. Group A patients (n = 150) used 2 L PEG before~     colonoscopy. Patients in group B (n = 150) were additionally advised to chew sugarless gum~     plus 2 L PEG, The overall quality of colonoscopy cleaning was evaluated using the Boston~     Bowel Preparation Scale by endoscopists who was blinded to the intervention. Difficulty of~     procedure, patients' tolerance, and adverse events were also evaluated.~   "
80974|NCT02507024|"~     The aim of this project is to develop a disease specific patient reported outcome measure~     (PROM) for patients with AAV (the AAV-PRO). Investigators are developing and validating a~     questionnaire to assess quality of life in patients with ANCA-associated vasculitis (AAV).~     Patients with AAV have inflammation in the small blood vessels leading to involvement of a~     range of organs and can suffer from ongoing disease activity or treatment side effects.~     Quality of life can be measured by patient reported outcome measures (PROMs).~   "
80975|NCT02507011|"~     The investigators will conduct a, randomized, phase 2, placebo-controlled, double-blinded,~     crossover trial of carvedilol in 26 PAH patients with World Health Organization functional~     class II or III symptoms and RV ejection fraction (EF) < 45% for 6 months.~   "
80976|NCT02506998|"~     The purpose of this study is to determine the changes of quality of life of patients with~     allergic rhinoconjunctivitis treated with standard medications plus Dialyzable Leukocyte~     Extracts (DLE). All patients will receive DLE in combination with current guide~     lines-suggested standard medication.~   "
80977|NCT02506985|"~     The trial is an open-label, randomized, trial examining novel biomarkers of thrombosis in~     patients managed with rivaroxaban vs. standard care following treatment of pulmonary embolism~     (PE) with catheter-guided alteplase. Patients >18 years old who present with PE and are~     managed with catheter-guided alteplase will be screened for study inclusion. Patient's~     meeting inclusion/exclusion criteria will undergo informed consent. Immediately following~     completion of alteplase infusion, patients will be randomized to receipt of rivaroxaban 15 mg~     oral bid for 21 days followed by 20mg oral daily or continuation on unfractioned heparin or~     low-molecular weight heparin with initiation of warfarin adjusted to INR of 2-3. Blood~     samples will be taken within 2 hours of CDT completion prior to receipt of study treatment~     (study day 1), at 8h-12h, 24h, 48h, 5d (or prior to hospital discharge), and at 30 day~     follow-up. Clinical endpoints, including bleeding, evidence of thrombosis progression, and~     death will be tracked during index hospitalization and at follow-up 30 days post-discharge.~   "
80978|NCT02506972|"~     The purpose of this study was to determine the impact of serving size and the addition of~     sugar on the glycemic response elicited by oatmeal compared to that elicited by cream of rice~     cereal.~   "
80979|NCT02506959|"~     The goal of this clinical research study is to learn if a combination of panobinostat,~     gemcitabine, busulfan, and melphalan and a stem cell transplant can help to control MM. The~     safety of this combination will also be studied.~      This is an investigational study. Panobinostat and melphalan are FDA approved for the~     treatment of MM. Busulfan is FDA approved for the treatment of leukemia. Gemcitabine is FDA~     approved for the treatment of lymphoma, breast cancer, and lung cancer. The use of these~     study drugs in combination is investigational. The study doctor can explain how the study~     drugs are designed to work.~      Up to 80 participants will take part in this study. All will be enrolled at MD Anderson.~   "
80992|NCT02506790|"~     This study evaluates the addition melatonin and metformin to toremifene in the treatment of~     locally advanced breast cancer. Third of patients will receive toremifene, other third will~     receive combination of melatonin and toremifene and other patients will receive combination~     of metformin and toremifene.~   "
80993|NCT02506777|"~     This study evaluates the addition melatonin and metformin to conventional chemotherapy FDC~     (Fluoruracil, Doxorubicin, cyclophosphamide) in the treatment of locally advanced breast~     cancer. Third of patients will receive FDCх6 cycles, other third will receive combination of~     melatonin and FDCх6 cycles and other patients will receive combination of metformin and FDCх6~     cycles.~   "
80994|NCT02506751|"~     This study will evaluate the safety and tolerability of synthetic T3, liothyronine. It will~     establish if there are changes in MS symptoms and if there is a positive effect on markers of~     neuronal health.~   "
81002|NCT02506647|"~     This is a Phase 1, exploratory, single dose, randomized, double-blind, two-way cross over,~     pilot, glucose clamp study to assess pharmacokinetic and pharmacodynamic effects of Gan &~     Lee's insulin glargine injection in comparison to the marketed Lantus (US) in subjects with~     type 1 diabetes mellitus (T1DM).~   "
80980|NCT02506946|"~     This project focuses on an at-risk adolescent and young adult population who may gain~     long-term health benefits from detection of risk factors at a young age. The primary aims of~     this proposal are: 1) To observe whether adolescents and young adults with Polycystic Ovary~     Syndrome (PCOS) are more likely to have elevated liver fat (>/=4.8%) than controls by~     studying liver fat deposition measured by magnetic resonance spectroscopy (MRS); 2) To assess~     the association of percentage liver fat with biomarkers of Non-alcoholic fatty liver disease~     (NAFLD), dyslipidemia, insulin resistance and body composition in PCOS and controls.~      In the proposed study, 40 adolescents and young adults with PCOS and 40 age-comparable~     control subjects will be evaluated for metabolic disturbances and elevated liver fat using~     noninvasive and state-of-the-art techniques including MRI, dual-energy x-ray absorptiometry~     and an oral glucose tolerance test in order to fully assess the metabolic and body~     composition differences between these groups. This research proposal represents a critical~     step in understanding the metabolic and cardiovascular comorbidities of PCOS and their~     relationship to NAFLD. The investigator hopes to use the results generated by this research~     proposal in order to lay the groundwork for the prevention and treatment of metabolic~     disorders in adolescents with PCOS. The overarching goal is to decrease and prevent lifelong~     morbidity associated with this common disorder.~   "
80981|NCT02506933|"~     This randomized phase II trial studies the safety and how well multi-peptide cytomegalovirus~     (CMV)-modified vaccinia Ankara (MVA) vaccine works in reducing CMV complications in patients~     previously infected with CMV and are undergoing a donor hematopoietic cell transplant. CMV is~     a virus that may reproduce and cause disease and even death in patients with lowered immune~     systems, such as those undergoing a hematopoietic cell transplant. By placing 3 small pieces~     of CMV deoxyribonucleic acid (DNA) (the chemical form of genes) into a very safe, weakened~     virus called MVA, the multi-peptide CMV-MVA vaccine may be able to induce immunity (the~     ability to recognize and respond to an infection) to CMV. This may help to reduce both CMV~     complications and reduce the need for antiviral drugs in patients undergoing a donor~     hematopoietic cell transplant.~   "
80982|NCT02506920|"~     The investigators wanted to study the postprandial lipemia after six oral fat tolerance test~     with varying amounts of saturated fat in young healthy subjects.~   "
80983|NCT02506907|"~     The overall aim of this work is to assess the relationship between stroke risk and~     hemodynamic compensation strategies, as measured using a novel 3.0 Tesla MRI protocol, in~     patients with symptomatic intracranial (IC) steno-occlusive disease. Recent studies have~     shown high two-year ischemic stroke rates in symptomatic patients with IC arterial stenosis.~     Therapy for IC stenosis patients includes revascularization with angioplasty, IC stenting, or~     bypass, however identification of patients most likely to benefit from these more aggressive~     interventions, rather than medical management alone, has been problematic. Accurate~     measurements of hemodynamic compromise are likely required to better define stroke risk and~     guide treatment decisions. Specifically, in IC stenosis patients with compromised cerebral~     perfusion pressure (CPP), the extent of hemodynamic compromise reflects the autoregulatory~     capacity of vasculature to increase arterial cerebral blood volume (aCBV) and/or develop~     collaterals to supplement cerebral blood flow (CBF). The prevalence of CBF collateralization~     and aCBV autoregulation has been hypothesized to correlate uniquely with stroke risk, however~     the extent of this correlation has been debated. The critical barrier to stratifying stroke~     risk rests with a lack of (i) methodology for measuring multiple hemodynamic factors with~     high specificity and (ii) noninvasive approaches capable of monitoring longitudinal~     progression of impairment. The investigators have demonstrated the clinical utility of~     relatively new, noninvasive MRI approaches for assessing cerebrovascular reactivity (CVR),~     aCBV, and collateral CBF. The investigators hypothesize that stroke risk can be more~     completely evinced from collective measurements of these parameters. Therefore, the~     investigators propose to implement a novel, validated hemodynamic MRI protocol to assess~     tissue-level impairment and compensation strategies in patients with IC stenosis. Using a~     collective approach combining measurements of collateral CBF, aCBV and CVR in multiple brain~     regions, in conjunction with a statistical model incorporating the above variables as~     possible prognostic factors, the investigators will quantify the extent to which two-year~     stroke risk is associated with hemodynamic compensation mechanisms. The noninvasive and~     multi-faceted scope of this investigation is intended to expand the diagnostic stroke~     infrastructure and elucidate new hemodynamic prognostic indicators of stroke in this~     high-risk population.~   "
80984|NCT02506894|"~     Two groups of women with preterm labor will be included. One will receive magnesium sulfate~     for neuroprotection and the other will receive placebo. Fetal middle cerebral artery Doppler~     indices will be measured before and after intake of either magnesium sulfate or placebo to~     find if any significant changes occur in fetal cerebral blood flow.~   "
80985|NCT02506881|"~     This is a randomized double-blind crossover study of pharmacokinetics, pharmacodynamics and~     safety of BCD-066 (darbepoetin alfa manufactured by CJSC BIOCAD, Russia) and Aranesp® (Amgen~     Europe B.V., Netherlands) in healthy volunteers. The purpose of the study is to demonstrate~     the equivalence of pharmacokinetics, pharmacodynamics and safety parameters after single~     subcutaneous or intravenous injection. Each drug will be administered to each volunteer at a~     dose of 1 µg per kilogram as a single subcutaneous or intravenous injection with an interval~     of at least 25 days.~   "
80986|NCT02506868|"~     The purpose of the study is to prove equivalence of efficacy and safety of BCD-066 and~     Aranesp® in treatment of anemia in end-stage chronic kidney disease patients on dialysis.~   "
80987|NCT02506855|"~     This study attempts to learn about the effectiveness of a modification to the Transversus~     Abdominis Plane (TAP) block that works by anaesthetizing the sensory afferents of the~     abdominal wall postoperatively using ultrasound guidance. The investigators want to see if~     regional blocks placed by the surgeon intraoperatively to assure regional anesthetic spread~     in the appropriate plane could reduce error and improve postoperative recovery.~   "
80988|NCT02506842|"~     The purpose of this study is to investigate the activity and safety of second-line adjuvant~     therapy with nab-paclitaxel plus gemcitabine (AG) versus oxaliplatin plus folinic acid and~     fluorouracil (OFF) for gemcitabine-refractory pancreatic cancer after curative resection.~   "
80989|NCT02506829|"~     The investigators plan to compare the impact of two approaches for smoking cessation on~     smoking abstinence, use of evidenced-based therapy, and quality of life among a diverse~     population of patients at the Manhattan campus of the VA New York Harbor Healthcare System,~     which serves a critical safety-net role for urban veterans. During hospitalization, all~     smokers will receive usual care. Patients will be randomized to one of two arms: financial~     incentives plus usual care vs. usual care alone, which includes referral to the state~     Quitline. All patients enrolled in the study will be offered nicotine replacement therapy.~     The investigators will conduct follow-up assessments at 2 weeks, 2 months, 6 months and 12~     months after discharge. The primary study outcome is smoking abstinence at 6-month follow-up,~     verified by salivary/urinary cotinine.~   "
80990|NCT02506816|"~     The primary objective of this study is to identify, in human tumour samples, biomarker~     changes associated to short exposure to AZD2281 as potential predictors of activity in~     Endometrial Carcinoma (EC).~      This is an exploratory study with a biological primary endpoint. Clinical efficacy or safety~     are not a primary objective of the study.~   "
80995|NCT02506738|"~     The aim of the study was to demonstrate the effectiveness of telemonitoring functional status~     and vital signs to early detect heart failure exacerbation, and to minimize readmissions and~     length of hospitalisations.~      Patients over 75 with heart failure were included after a hospitalisation due to heart~     failure exacerbation. Patients were assigned randomly into intervention or control. The~     intervention group comprised 47 patients who were assessed through telemonitoring, while 40~     followed traditional clinical pathways.~      Patients were followed-up for 3 months after discharge, collecting emergency visits and~     readmissions due to a new heart failure exacerbation. Those patients in the intervention~     group used a commercial telemedicine system: Careline H@me, which was provided by the company~     SALUDNOVA. They system was personalized by adding the functional status monitoring~     capabilities. Thus, the system collected vital signs (i.e. blood pressure, heart rate,~     respiratory rate, oxygen saturation, glucose, and weight); symptoms of decompensated heart~     failure (i.e. dyspnoea and orthopnoea); and functional status (i.e. part of the Short~     Physical Performance Battery, SPPB) and a brief questionnaire (i.e. Do you have the~     medication?) every 48 hours.~      Two staff geriatricians at the Hospital Universitario de Getafe accessed, during working~     days, a secured dedicated web-portal to assess the progression of their patients, evaluated~     through the monitored variables and the self reported symptoms. They reacted to the data, if~     needed, making a phone call or visiting the patient. Besides, patients could contact the~     geriatricians or attending the emergency room as usually.~      After completion, we analysed the results. First, we carried out a descriptive analysis of~     the data. Later, we analysed the effects of the intervention with telemedicine and the~     predictive values of the different measured variables through logistic regressions.~   "
80996|NCT02506725|"~     The goal of Quarenta Semanas is to remove risk factors for preterm birth by linking women to~     prenatal care in the first trimester; supporting, educating and empowering women in pregnancy~     to reduce maternal stress and interrupt social, psychological, attitudinal and biological~     risk factors for preterm birth; and providing evidence-based, quality care that identifies~     and intervenes medically to treat underlying chronic and emergent conditions associated with~     preterm birth.~   "
80997|NCT02506712|"~     The main objective is to quantify energy expenditure when using the SmartDrive system during~     manual wheelchair propulsion in external conditions (slope, straight line). For this two~     comparisons are performed:~      Comparison of energy expenditure with and without the use of a system SmartDrive 6 minute~     propulsion test.~      Comparison the risk of musculoskeletal disorders of the wrist during a 6 minute propulsion~     test.~   "
80998|NCT02506699|"~     For ten years, rTMS, repetitive transcranial magnetic stimulation of the motor cortex, has~     found its place in the treatment of drug-resistant neuropathic pain. Patients relieved by~     some sessions may thereafter receive a chronic invasive stimulation via electrodes implanted~     through a neurosurgical procedure. This is common practice at the University Hospital of Caen~     and in different CHU with the proper equipment rTMS. It seems permissible to provide in our~     center only a non-invasive technique for patients challenged with brain surgery, since~     according to the various meta-analyzes the analgesic efficacy of rTMS seems to be correlated~     to the repetition of sessions.~      Assessment centers and the treatment of pain allow a multidimensional assessment,~     bio-psycho-social of patients in order to optimize their management and experience~     efficiently analgesics first- and second-line.~      We propose a study evaluating the analgesic efficacy of rTMS, in relevant stimulation~     parameters reproduced according to a literature review, during 3 months after 5 active~     sessions separated by one week apart, in 15 patients with neuropathic pain chronic refractory~     to treatment of first and second line, followed by multidisciplinary center specializing in~     chronic pain Lower Normandy. The quality of life will also be assessed by validated scales,~     and the results will be compared to the literature data.~   "
80999|NCT02506686|"~     A prospective, open-label study investigated the pharmacokinetic profile of meropenem in~     patients with post-neurosurgical central nervous system (CNS) infection, especially its BBB~     penetration into cerebrospinal fluid (CSF).~   "
81000|NCT02506673|"~     Little is known about perioperative stress responses and possible anxiety mitigating factors~     like audiovisual aids or IV sedation. Most studies use surrogate markers and retrospective~     questionnaires, and are not based on real-time gathered data. Skin conductance measurements~     allow the sympathetic discharge to be evaluated down to fractions of a second and enable us~     to continuously monitor stress responses as skin conductance responses/per second during the~     perioperative management. In our study, the investigators propose to examine the effect of~     personal audiovisual equipment (audio/video goggles) on perioperative stress, pain, and~     overall experience in patients undergoing ambulatory meniscectomy under spinal anesthesia.~     Patients will be randomly assigned to either receive traditional sedation or light sedation~     in addition to audiovisual equipment. The investigators hope to determine outcome estimates~     of the use of this equipment on stress levels using skin conductance measurements, request~     for further sedation, postoperative pain levels and analgesic consumption, time to discharge~     readiness, and overall patient satisfaction, and collect thus far unavailable data on the~     stress response to perioperative stresses (such as IV insertion and spinal placement) in~     order to allow for power analyses for future studies.~   "
81001|NCT02506660|"~     Many patients undergoing ambulatory shoulder arthroscopy experience moderate to severe pain~     after surgery. Finding ways to minimize postoperative pain are ideal. Dexamethasone is a~     corticosteroid that is commonly used to prevent and/or treat nausea and inflammation. The~     addition of higher doses of dexamethasone to nerve blocks, which are injections of local~     anesthetics into the upper shoulder area, has been shown to prolong block duration and reduce~     pain. However, it is unclear whether the advantage of longer pain relief outweighs patient~     dissatisfaction with the prolonged feeling of a numb arm. Furthermore, recent studies have~     shown that systemic, intravenously administered dexamethasone may similarly reduce pain~     levels when compared with dexamethasone in the block. In our study, the investigators propose~     to examine the effect of low-dose IV versus block dexamethasone on interscalene block~     duration in patients undergoing shoulder arthroscopy. Most studies have used 4 mg or more.~     One study suggests that 1 mg may have the same effect as larger doses. Our aims are to~     determine whether the addition of low-dose dexamethasone to a local anesthetic in the block~     can prolong its duration, and whether there are differences in postoperative pain,~     consumption of painkillers, side effects, and satisfaction in patients who received IV or~     block dexamethasone. Patients (128 total) will be randomly assigned to either receive IV or~     block dexamethasone, and postoperative assessments (pain, painkiller use, side effects, block~     duration, satisfaction, complications) will be made via phone at 2, 3, 4 (if needed), and~     7-10 days after surgery. Results from this study will reveal whether patients prefer the~     longer-duration analgesia that may be obtained with low-dose dexamethasone in the block.~   "
81053|NCT02505971|"~     The purpose of this study is to assess the efficacy and safety of oral propranolol versus~     nadolol in patients with Infantile Hemangiomas (IH) in a randomized, controlled,~     double-blinded study.~   "
81003|NCT02506634|"~     Consecutive patients aged 18-65 years who go to the gastroenterology clinic presented with~     upper gastrointestinal discomfort would be included. All patients underwent upper endoscopy~     or an ambulatory 24-h pH(Potential Of Hydrogen) monitoring.Pathologic esophageal acid reflux~     was defined as the percentage total time for which a pH value < 4 was >4.2 % in the distal~     esophagus. Then, patients were treated with esomeprazole 20 mg twice daily for 28 days. The~     symptom scores were measured by the frequency score multiplied by the severity scores of the~     predominant symptom before and at the end of the treatment, and the  PPI test  was defined~     as positive if the overall scores of the predominant dyspeptic symptom in the fourth week~     decreased by >50 % compared with those of the baseline.~      GERD is defined by either 24-hour impedance-pH monitoring or positive PPI(proton pump~     inhibitor) test or positive result from endoscopy. The percentage of each symptom of GERD in~     the symptom questionnaire in Chinese outpatients in Gastroenterology department will be~     calculated. The symptom of the highest percentage will be the primary symptom.~   "
81004|NCT02506621|"~     Randomised crossover study comparing the sensitivity and specificity of 5 External loop~     recorders in detecting pacemaker detected Atrial fibrillation burden.~   "
81005|NCT02506608|"~     Phantom limb pain (PLP) is a frequent consequence of amputation, and it is notoriously~     difficult to treat. Amputation usually follows traumatic injuries or surgery following~     vascular diseases, diabetes, osteomyelitis or tumours in cases where the loss of the limb is~     required for the survival of the patient. The loss of a limb or other body parts is usually~     followed by the sensation that the lost body part is still present and can be felt. These~     phenomena are called, respectively, phantom awareness and phantom sensation. In 50-80% of~     amputees neuropathic pain develops in the lost limb also referred to as phantom limb pain~     (PLP). PLP can be related to a certain position or movement of the phantom limb, and might be~     elicited or worsened by a range of physical factors (e.g. changes in the weather or pressure~     on the residual limb) and psychological factors (e.g. emotional stress). It is well known~     that most treatments available for PLP today, such as pharmacological, surgical, anaesthetic,~     psychological and other, are ineffective. Today it is believed that phantom limb pain may be~     related to changes in the cortex of the brain. There is evidence that these changes may be~     modulated - or even reversed - by providing sensory input to the stump or amputation zone.~     For example, cortical reorganization and alleviation of phantom limb pain has been observed~     in amputees following intense use of a hand prosthesis. However, there is no consistent~     knowledge on which type of peripheral sensory feedback may be effective in affecting the~     cortical plasticity or on how to best apply the sensory feedback. The aim of the proposed~     research is to create natural, meaningful sensations through providing sensory feedback (i.e.~     surface or neural electrical stimulation) and the effectiveness to alleviate phantom limb~     pain and restore the cortical neuroplastic changes.~   "
81006|NCT02506595|"~     The purpose of this study is to obtain preliminary data of the efficacy of Exposure,~     Relaxation, and Rescripting Therapy for nightmares among active duty military personnel.~   "
81007|NCT02506582|"~     The purpose of this randomized, double-blind, placebo-controlled study was to determine~     whether jerusalem artichoke and fermented soybeans powder mixture is effective in the control~     of blood glucose level in subjects with prediabetes or newly diagnosed type 2 diabetes.~   "
81008|NCT02506569|"~     The investigation is designed to provide supporting evidence for the clinical safety of the~     Biotronik's new Implantable Cardioverter Defibrillator systems when used under specific 3~     Tesla MR conditions .~   "
81009|NCT02506556|"~     This is a phase II, exploratory, open-label, single arm study of BYL719 monotherapy, a~     selective phosphatidylinositol 3-kinase (PI3K) alpha inhibitor, in adult patients with~     advanced metastatic breast cancer progressing after first line therapy. Patients with~     advanced hormone receptor positive tumors will be required to have an alteration of the PI3K~     pathway. Those patients with advanced triple negative breast cancers are genetically~     unselected for this study.~   "
81010|NCT02506543|"~     The study is a randomized controlled trial of COMPASS, an intervention for adolescent girls~     in three refugee camps in Ethiopia. The study design will employ a two group wait-list~     cluster randomized controlled trial where girls will be invited to participate in the COMPASS~     program, assigned to groups of approximately 20 for the purposes of the program, complete a~     pre-test baseline assessment, and will then be randomized by group to the intervention or~     control condition. In addition, qualitative research will address additional questions of~     acceptability, processes of change and best practice.~      Groups in three refugee camps - Sherkole, Bambasi, and Tongo - will be randomized to~     determine whether the participants receive the intervention or are placed on the wait-list~     immediately following the baseline. Those that do not get the curriculum during the study~     will receive it following the endline phase of the study so as to not create tensions or~     jealousies.~      The intervention, the COMPASS program, will involve a structured intervention for girls~     between the ages of 13-19 that is intended to engage adolescent girls, those who are~     influential in their lives, service providers and other stakeholders, with the ultimate goal~     of co-creating environments in which girls are valued and safe. The program is centered on~     establishing or supporting community-supported safe spaces for girls where they can come and~     gather among themselves and participate in a structured life-skills curriculum.~   "
81011|NCT02506530|"~     This study will assess the benefit of LPG Cellu M6 in addition of intensive decongestive~     treatment in reducing secondary lymphoedema in breast cancer.~   "
81012|NCT02506517|"~     This is a phase 2 study (the second phase in testing a new drug) to see how useful an~     investigational drug called afatinib is in patients with advanced cancer with changes in the~     HER gene.~      Afatinib is a drug that is approved by Health Canada for the treatment of advanced lung~     cancer with changes in the HER gene. Afatinib works by attaching to and blocking a protein~     called HER from working. HER is an important protein that contributes to the growth of cancer~     cells.~   "
81013|NCT02506504|"~     In patients with severe Chronic Obstructive Pulmonary Disease (COPD), exercise tolerance is~     severely impaired due to a ventilatory limitation, levelling off the intensity of exercise.~     This reduces the physiological benefit of pulmonary rehabilitation. In these patients, it is~     then proposed to add an Inspiratory Pressure Support (IPS) in order to increase the intensity~     and the duration of every training session. In a preliminary study, the investigators showed~     that IPS applied during an exhaustive cycling exercise allowed to prevent the onset of~     post-exercise quadriceps fatigue evaluated by the endurance time to isotonic quadriceps~     contractions (TlimQ).~      The aim of this study is to determine the relationship between the prevention of~     post-exercise fatigue (TlimQ) and the change in training load (intensity x time x number of~     sessions) during a pulmonary rehabilitation programme. At the beginning of the training~     programme, 25 patients will be evaluated for TlimQ after a cycling exercise (70% maximal~     workload) with and without IPS in random order. The training load was then monitored at every~     exercise session of the programme.~   "
81014|NCT02506491|"~     This study is based on assess and contrast isometric and isokinetic core strength, static and~     dynamic balance, the number of falls, and functional autonomy in three different old women~     groups after a 22 weeks 1) Pilates-based structured exercise program, 2) muscular structured~     exercise program, and 3) nonexercising.~   "
81015|NCT02506478|"~     ED patients who are able to drink juice will be approached and asked their beverage~     preference.~   "
81016|NCT02506465|"~     The study objectives are to demonstrate the efficacy and safety of the Medi-Tate iTIND as~     compared to control group (catheter only).~   "
81017|NCT02506452|"~     The purpose of this study is to compare the wound closure outcomes of subjects receiving~     diabetic foot ulcer treatment with and without the use of Biovance®.~   "
81018|NCT02506439|"~     Randomised, placebo-controlled dose-response intervention study with vitamin D3 in pregnant~     women.~   "
81019|NCT02506426|"~     Chronic sinusitis is a disease involving severe swelling of your facial sinuses and nasal~     cavity. Chronic sinusitis is a common disorder and roughly 5% of adult men and women have~     chronic sinusitis in Canada. Surgery has shown to have benefits for people suffering from~     chronic sinusitis. There are two surgeries which have been shown to help people: 1)~     Endoscopic sinus surgery with septoplasty and 2) Septoplasty alone. Both surgeries have~     research which show they help improve quality of life and reduce symptoms. However, it is~     unknown which surgery is better.~      'Endoscopic sinus surgery with Septoplasty' uses special telescopes through the nostrils to~     make the nasal septum straight and open the facial sinuses without any incisions. The sinuses~     are opened using special microscopic instruments and the procedure takes approximately 90-120~     minutes.~      'Septoplasty alone' is a shorter (take approximately 25-30 minutes) and less invasive (do not~     open the facial sinuses) that might provide the same benefits compared to the larger and~     longer endoscopic sinus surgery.~      Currently, performing 'Endoscopic Sinus Surgery and Septoplasty' together is the standard of~     care, however, there is limited evidence to support just performing 'Septoplasty alone'~     provides similar results but it is shorter and has lower risks. This represents a significant~     gap in the investigators' knowledge, which adversely impacts a doctor's ability to counsel~     patients who have chronic sinusitis and elect to undergo surgery.~      The purpose of this study is to understand which surgery (endoscopic sinus surgery plus~     septoplasty OR septoplasty alone) is the most appropriate for people with chronic sinusitis.~     You are being asked to participate in this study because you have chronic sinusitis and are~     also going to have surgery to improve your quality of life.~   "
81020|NCT02506413|"~     This study aims to adapt and implement a district-led, policy-based, low cost Maternal and~     Newborn Health (MNH) intervention package using the MamaToto process, proven successful in~     Uganda, in rural Tanzania. The investigators hypothesize that the 'MamaToto Package' will be~     successfully implemented in the Misungwi District and will be effective in improving key~     maternal and newborn health indicators of study participants.~   "
81021|NCT02506387|"~     The primary objective of the registry is to investigate and follow all patients treated with~     the MitraClip System in Belgium. This information is intended to contribute to decision~     making with regards to MitraClip therapy selection in patients with mitral regurgitation: (a)~     by establishing the clinical value of the MitraClip therapy in the continuum of care; and (b)~     by providing practical information that will allow physicians to make therapeutic decisions,~     assist hospitals to make purchasing decisions, and assist insurers/government in making~     coverage decisions.~      In addition national data will be shared with European registries in order to increase the~     knowledge about the efficacy of this new technique.~   "
81022|NCT02506374|"~     This non-intervention qualitative study will use focus groups to assess the feasibility and~     acceptability of a proposed intervention for a future study. The focus group will discuss a~     potential biobehavioral family self-management intervention designed to improve sleep in~     persons with Alzheimer's disease (PAD) and their caregivers (CG).~   "
81023|NCT02506361|"~     This is a prospective、multicenter、non-comparative interventional case series. 800 breast~     cancer patients who have already received chemotherapy prior to this study will be enrolled~     in the group, including 400 patients received the anthracyclines followed taxanes~     chemotherapy, and the other 400 patients who have received regiments containing no taxanes.~     Three tumor tissue slices of all the enrolled patients will be collected for TOP2α assay.~     Meanwhile, 10 years followed-up survey will be conducted. The relationship of TOP2α~     expression and 5- year or 10-year disease free survival(DFS) and overall survival（OS）will be~     identified in this study.~   "
81024|NCT02506348|"~     In this study we test Diclofenac and Nepafenac and compared patients experience and comfort~     following administration of these ophthalmic drops.~   "
81025|NCT02506335|"~     Background: It is still difficult to predict the outcome in patients requiring Fontan~     Revisions and in those who have evidence of congestive hepatopathy and probable cirrhosis~     requiring major cardiac surgery including heart transplant. Over the years, many prognostic~     indices have been derived from laboratory results of blood tests, clinical and physiological~     variables (or some combination thereof), from liver imaging to liver histology, which has~     issues of sampling error, medical risks and technical difficulty. None of these have proved~     entirely satisfactory. Predicting morbidity or survival is particularly important when~     deciding about Fontan revisions versus the need for heart transplantation. What is needed~     here is a truly reliable test of liver function that can help predict outcome, on the basis~     of a single measurement within few days of a planned revision. For this purpose, it is~     desirable that the chosen tests of liver performance be safe, non-invasive, easy to perform,~     have a rapid turnaround for results, and be readily repeatable.~      Tests of hepatic elimination of various exogenous substances have been described, such as~     galactose elimination capacity (GEC), indocyanine green (ICG) clearance, lidocaine metabolism~     to monoethylglycinexylidide (MEGX), and other tests that rely on liver metabolic capacity.~     None of these metabolic or clearance tests achieved widespread acceptance or use, mostly~     because their performance and analyses were cumbersome.~      HepQuant,LLC has developed a platform of tests of liver function which include Systemic~     Hepatic Filtration Rate (HFR), Portal HFR, SHUNT, and Disease Severity Index (DSI)1,2.~     HepQuant tests specifically target the hepatic uptake of cholate and use a single noninvasive~     test of 90 minutes duration to quantify the systemic circulation, portal circulation, and~     portal-systemic shunt and to derive a DSI in intact human subjects. HepQuant tests can assess~     all stages and etiologies of liver disease. In chronic HCV patients HepQuant testing can~     predict which patients will respond to antiviral therapy and can measure the improvement in~     hepatic function that occurs after successful antiviral therapy. Patients who did not respond~     were followed for an average of 5 years and up to 8 years, and baseline HepQuant testing~     could predict clinical outcomes (CTP progression, variceal bleeding, encephalopathy, ascites,~     liver-related death) with 87% sensitivity and 71% specificity.~   "
81075|NCT02505685|"~     The purpose of this study is to evaluate the use of Dynamic PET/CT as a tool to assess~     disease response to anti-cancer therapy in Lung Cancer patients.~   "
81026|NCT02506322|"~     This efficacy study compares an adjuvant specific psychotherapy and an active control~     intervention for Bipolar Disorder under mood stabilizer to prevent relapse an maintain~     remission. Patients should be in their early (18-30 yr.) phase of illness without having~     suffered of to many affective episodes (below 6), already. In addition, psychological,~     social, and neurobiological mediators and moderators well be identified.~   "
81027|NCT02506309|"~     Mid-urethral slings (MUS) now represent a gold standard in the treatment of female stress~     urinary incontinence (SUI). Second generation trans-obturator slings (TOT) have proven to be~     as effective as retropubic tension-free vaginal tape (TVT) with fewer major complications. A~     third generation of the MUS inserted through a single vaginal incision (SIS) has become a~     means to overcome significant post-operative groin pain. Novel types of SIS with a more~     robust and adjustable anchoring mechanism can assure adequate long-lasting attachment to the~     obturator membrane (OM). Objective of this study was to compare an inside-out TOT with an~     innovative fixation SIS in randomized controlled trial on patients undergoing their primary~     surgery for urodynamic SUI.~   "
81028|NCT02506296|"~     Patients with type 2 diabetes have very variable endogenous insulin secretion. While some~     patients have relatively preserved endogenous insulin with marked insulin resistance others~     may develop the very severe insulin deficiency seen in type 1 diabetes. The impact of this~     variation on hypoglycaemia risk and treatment response in type 2 diabetes is unclear. This~     project aims to determine the impact of residual endogenous insulin secretion on glucose~     variability, hypoglycaemia risk and treatment response in insulin-treated participants with a~     clinical diagnosis of type 2 diabetes. The investigators will recruit participants from~     existing cohorts known to have severe insulin deficiency despite classical clinical~     characteristics of type 2 diabetes. The investigators will recruit other participants with~     insulin-treated type 2 diabetes and retained endogenous insulin secretion matched for~     glycemia and gender. The investigators will assess glucose variability (using continuous~     glucose monitoring system (CGMS)) and treatment response to a single dose of the glucose~     lowering therapy vildagliptin and compare responses between groups. This study will allow us~     to assess the potential utility of measuring endogenous insulin secretion in insulin-treated~     type 2 diabetes as a marker of hypoglycaemia risk and in determining likely response to oral~     therapy.~   "
81029|NCT02506283|"~     This study investigates the effects of cooling on the recovery and performance characteristic~     in young healthy subjects. The study is divided in two projects:~      Project A: investigates the effects of 20 min. post-exercise cooling on vertical jump~     performance and delayed onset muscle soreness and rated perceived exertion.~      Project B: investigates the effects of 20 min. pre-exercise cooling on maximal voluntary~     contraction of the right M. quadriceps femoris and delayed onset muscle soreness and rated~     perceived exertion.~   "
81030|NCT02506270|"~     The aim of the investigators' study is to investigate if the use of the AirSeal insufflation~     system impairs ventilatory parameters of patients less than a conventional system in patients~     undergoing robot-assisted laparoscopic cystectomy.~   "
81031|NCT02506257|"~     Randomized, double-masked, placebo-controlled, multiple center, parallel-group Phase 1 study~     to evaluate the safety and tolerability of 3 doses of preservative-free PHMB ophthalmic~     solution compared to placebo in healthy subjects~   "
81032|NCT02506244|"~     The purpose of this study is to investigate whether it is possible to identify a high-risk~     cohort suitable for screening for asymptomatic atrial fibrillation using claims data, and~     then engage those individuals in a mobile health technology-enabled home monitoring program~     in order to document previously undiagnosed atrial fibrillation, and provide clinical~     evidence of an outcomes benefit associated with this early detection.~   "
81033|NCT02506231|"~     The purpose of this study is to assess the impact of folinic acid (FA) -rescue following~     methotrexate (MTX) graft-versus-host disease (GVHD) prophylaxis on regimen related toxicity~     and transplantation outcomes after allogeneic hematopoietic cell transplantation (alloHCT) in~     a double blind randomized controlled trial.~   "
81034|NCT02506218|"~     This study will be conducted using standardized techniques to collect blood samples via an~     acute, randomized, cross-over design. Subjects will be provided all of their meals the day~     prior to testing and participate in 3 testing days with a minimum of 1 week break between~     testing days and a maximum time commitment of 7 weeks. A trained phlebotomist will place a~     catheter and collect blood samples from an antecubital vein using sterile techniques.~   "
81035|NCT02506205|"~     A handful of studies have examined the effects of the Lee Silverman Voice Treatment (LSVT)~     LOUD on hypokinetic dysarthria in English speakers with Parkinson's disease (PD). Although~     LSVT LOUD has been found to be effective on improving these speaker's vocal intensity and~     increasing their speech intelligibility as well as speech function with Phase I evidence, no~     study has investigated whether Mandarin-speaking individuals with dysarthria secondary to PD~     would benefit from LSVT LOUD. In the proposed study, speech data of Mandarin-speaking~     individuals with hypokinetic dysarthria before and after speech therapy will be audio~     recorded and analyzed in order to examine the effects of LSVT LOUD on the speech function in~     this population. The same speech data will be played to Mandarin listeners in order to~     investigate the speech intelligibility of this population. It is hypothesized that~     Mandarin-speaking individuals with hypokinetic dysarthria secondary to PD will demonstrate~     reduced vocal intensity, reduced speech intelligibility and impaired speech function before~     they receive LSVT LOUD. They will improve these speech characteristics following speech~     therapy and will present with short-term maintenance effects.~   "
81036|NCT02506192|"~     The primary objective of this clinical trial is to determine if treatment with an~     anti-inflammatory drug (delayed-release prednisone) improves the health-related quality of~     life (HRQOL) of veterans with Gulf War Illness (GWI). The primary outcome measure is a change~     from baseline of HRQOL with respect to physical functioning and symptoms. Secondary outcomes~     measures include changes from baseline levels of GWI-associated biomarkers of inflammation in~     peripheral blood, GWI-associated symptoms (chronic pain, fatigue, and cognitive impairment),~     and HRQOL with respect to mental functioning.~   "
81037|NCT02506179|"~     To evaluate the real-life effect after 1 year of adalimumab treatment on psychological~     distress/depression symptoms in moderate-to-severe Ulcerative Colitis (UC) patients.~   "
81038|NCT02506166|"~     The objective of ESCAPE-SCD Study is assessment of the effect of sleep apnea on sudden~     cardiac death risk and cardiovascular outcomes in patients with ischemic cardiomyopathy. The~     ESCAPE - SCD Study will address following specific study questions:~        -  Is obstructive sleep apnea (OSA) and/or central sleep apnea (CSA) an independent risk~          factor of sudden cardiac death (SCD) in patients with ischemic cardiomyopathy (ICM)~          indicated for ICD/CRT-D implant based on current European Society of Cardiology (ESC)~          Guidelines for primary prevention of sudden cardiac death?~        -  Can treatment of predominant (>50%) obstructive sleep apnea by appropriate Positive~          Airway Pressure (PAP) therapy decrease risk of sudden cardiac arrhythmic death in ICM~          patients?~        -  Can treatment of predominant (>50%) obstructive sleep apnea by appropriate PAP therapy~          improve cardiovascular outcomes in ICM patients indicated for ICD/CRT-D implant?~        -  Does obstructive sleep apnea represent a novel factor that may improve risk~          stratification of sudden cardiac death and advance identification of those patients that~          will benefit from ICD/CRT-D therapy?~   "
81039|NCT02506153|"~     This randomized phase III trial studies how well high-dose recombinant interferon alfa-2B or~     ipilimumab works compared with pembrolizumab in treating patients with stage III-IV melanoma~     that has been removed by surgery but is likely to come back or spread. High-dose recombinant~     interferon alfa-2B may help shrink or slow the growth of melanoma. Monoclonal antibodies,~     such as ipilimumab and pembrolizumab, may block tumor growth in different ways by targeting~     certain cells. It is not yet known whether high-dose recombinant interferon alfa-2B or~     ipilimumab is more effective than pembrolizumab in treating patients with melanoma.~   "
81040|NCT02506140|"~     Ticagrelor is a reversible and direct-acting oral antagonist of the P2Y12 (Purinergic~     receptor P2Y, G-protein coupled, 12) receptor for adenosine diphosphate, which provides~     faster, greater, and more consistent P2Y12 inhibition than Clopidogrel in patients with acute~     coronary syndrome, irrespective of the genetic variants affecting Clopidogrel metabolism. It~     is still undefined whether combination therapy of Ticagrelor and Aspirin is more effective~     than Clopidogrel and aspirin for minor stroke and transient ischemic attack (TIA). The~     primary purpose of the PRINCE trial is to evaluate the anti-platelet effects of a 3-month~     regimen of ticagrelor initiated with 180 mg loading dose followed by 90 mg twice/day combined~     with aspirin 100 mg/day during first 21 days versus a 3-month regimen of clopidogrel~     initiated with 300 mg loading dose of followed by 75 mg/day combined with aspirin 100 mg/day~     during first 21 days when initiated within 24 hours of symptom onset in high-risk transient~     ischemic attack or minor stroke.~   "
81041|NCT02506127|"~     This study will evaluate the effectiveness of intermittent Theta Burst Stimulation for~     patients with Major Depressive Disorder.~   "
81042|NCT02506114|"~     This is a multicentered, open label, randomized phase II trial of PROSTVAC or ipilimumab or~     the combination of PROSTVAC and ipilimumab as neoadjuvant therapy in patients with localized~     PC. Eligible patients will be randomized to PROSTVAC monotherapy (Arm A), ipilimumab~     monotherapy (Arm B), or combination therapy with both PROSTVAC and ipilimumab (Arm C), prior~     to RP. In arms A and C, PROSTVAC-V will be administered subcutaneously as the primary vaccine~     on Day 1, which will be followed 2 weeks later with a series of 2 PROSTVAC-F subcutaneous~     administrations, given 3 weeks apart. In arms B and C, ipilimumab will be administered twice,~     at a dose of 3mg/kg, 3 weeks apart. In the combination arm, ipilimumab administration will~     coincide with the PROSTVAC-F administration. In arm B, ipilimumab will begin on Day 1. In all~     three arms, RP will occur 21 days, or three weeks, following final treatment administration~     of PROSTVAC or ipilimumab. No further therapy will be administered on study following RP.~   "
81043|NCT02506101|"~     The objective of this study is to assess the effectiveness and safety of~     narrowband-ultraviolet B (NB-UVB) treatment in adult subjects with vitiligo.~   "
81044|NCT02506088|"~     The present research creates a partnership between researchers and a community agency to~     evaluate whether a sexual assault prevention program for high school students reduces~     perpetration of sexual violence among high school boys.~   "
81045|NCT02506075|"~     The primary objective of this study is to confirm and compare the effect of methods of~     transcranial direct current stimulation(tDCS) in the unilateral neglect of stroke patients~   "
81046|NCT02506062|"~     This trial will test the efficacy of brief periods of controlled limb ischemia (remote~     ischemic preconditioning, RIPC) as an effective treatment of patients with Raynaud's~     Phenomenon (RP).The hypothesis of this trial is that due to its vasoprotective effects, RIPC~     would be more effective than placebo in the treatment of both primary and secondary RP, as~     defined by decreased frequency, duration, and severity of attacks. This trial was also~     designed to monitor the tolerance of RIPC in a rheumatologic population. Patients will not be~     required to stop any current treatment for RP.~   "
81047|NCT02506049|"~     Humanitarian use device (HUD): Use of the fetoscopy instrument sets for selective laser~     photocoagulation in the treatment of Twin to Twin Transfusion Syndrome (TTTS).~   "
81048|NCT02506036|"~     This study is being done to test the feasibility and effectiveness of web-based~     social-cognitive training exercises in treating social-emotional deficits in patients with~     stroke or frontotemporal dementia (FTD).~   "
81049|NCT02506023|"~     The purpose of this study is to determine how female hemophilia A carriers respond to a~     medication called DDAVP (Desmopressin).~   "
81050|NCT02506010|"~     The purpose of this study is to conduct an oxygen saturation (SpO2) accuracy validation~     comparing prototype pulse oximeter oxygen saturation measurements directly to arterial blood~     saturation during non-motion conditions over the range of 60-100% SaO2 as measured by~     Reference CO-Oximetry. Additionally, the prototype pulse oximeter pulse rate measurements~     will be compared to 3-lead ECG heart rate measurements made via a multi-parameter monitor.~   "
81051|NCT02505997|"~     The purpose of this study is to evaluate the effect of repeated doses of oral delafloxacin on~     the pharmacokinetic (PK) profile of a single oral dose of midazolam.~   "
81052|NCT02505984|"~     The purpose of this study is to test a new treatment for preventing childbirth-related mental~     illness in postpartum mothers. The treatment is aimed at enhancing maternal bonding, reducing~     postpartum depression (PPD) and anxiety in mothers at risk, and promoting child development.~     To this end, the investigators will test the clinical utility of intranasal (IN) oxytocin~     (OXT) administered to mothers during the first postpartum days.~   "
81054|NCT02505958|"~     Objective: To show that a 1-2 day reduction of caloric intake can reduce the insulin~     resistance produced by several days of overnutrition. Approach: Healthy volunteers will be~     admitted to the Clinical Research Center and undergo a baseline euglycemic-hyperinsulinemic~     clamp study to assess their insulin resistance. Subjects will then start on an overnutrition~     program for 4 days consisting of 3 meals and 3 snacks containing ~6,000 Kcal/24hours. A~     second clamp study will be performed on day 5 to demonstrate the overnutrition induced~     increase in insulin resistance. Starting on day 5 the subject's caloric intake will be~     reduced to ~1,000 Kcal for 2 days (day 5 and 6). After that on the morning of day 7, a third~     hyperinsulinemic-euglycemic clamp will be performed to determine whether the reduced caloric~     intake did reduce insulin resistance and the volunteer will be discharged from the Clinical~     Research Center.~   "
81055|NCT02505945|"~     This study compares mechanical sphincter augmentation (LINX Reflux Management System) to~     double-dose proton pump inhibitors (PPIs) for the management of reflux symptoms related to~     gastroesophageal reflux disease (GERD).~   "
81056|NCT02505932|"~     To date, use of arthroscopic procedure to perform Latarjet procedure is still technically~     demanding. The benefits of arthroscopic procedure need to be evaluated compared to the~     mini-invasive approach. The aim of this study was to assess postoperative pain during the~     first week, and the positioning of coracoid bone block at the anterior aspect of the glenoid.~     At minimum 2 years follow-up, the recurrence of shoulder instability and functional~     evaluation of patients according to the Western Ontario Score Index (WOSI) were assessed.~   "
81057|NCT02505919|"~     A prospective multicenter randomized blinded study comparing Aquablation of the prostate with~     the AQUABEAM System and TURP for the treatment of Lower Urinary Tract Symptoms (LUTS). The~     primary endpoints for safety and effectiveness will be measured at 3 and 6 months,~     respectively, and subjects will be followed out to 3 years to collect long-term clinical~     data.~   "
81058|NCT02505906|"~     In summary, breast conserving therapy (BCT) is an effective, save and widely used treatment~     technique for early breast cancer. Radiotherapy has shown to give better local control and~     survival benefit and is an integrated part of BCT. The simultaneous integrated boost (SIB)~     technique is a new treatment technique in breast irradiation. In this technique the whole~     breast is irradiated simultaneous with boosting the tumour bed, as part of BCT. Late~     radiation-induced toxicity has not been investigated in patients treated with radiotherapy~     using this technique. Proposed study will study the late radiation-induced toxicity, describe~     patients-rated complaints, quality of life, survival and local control curves in patients~     treated for early breast cancer with breast-conserving surgery in combination with~     radiotherapy with the SIB technique as compared to sequential radiotherapy treatment.~   "
81059|NCT02505893|"~     This is a prospective phase 2, single-arm, mono-center pilot study. It has been designed to~     investigate whether giving the combination therapy consisting of minimal islet~     transplantation (1500 EIQ/Kg body weight), Thymoglobulin® (ATG), Rapamune® (rapamycin) and~     Neulasta® (pegfilgastrim) to patients with Type 1 Diabetes (T1D) at onset is safe and~     secondarily, if it will preserve insulin production. It will involve 6 patients with~     new-onset T1D. Each patient will be involved in the study for a screening period and a~     post-islet transplantation study period of 52±2 weeks, to include 1 treatment cycles of 12~     weeks, assessment during treatment and 5 follow-up visits scheduled at weeks 2±1 (14 days),~     4±1 (month 1), 12±2 (month 3), 26±2 (month 6) and 52±2 (month 12).~   "
81060|NCT02505880|"~     In adults, it is common to perform a number of superficial and non invasive surgeries under~     local anesthesia in order to limit the use of general anesthesia.~      Hypnosis is a nonpharmacological therapies that can be used during surgery to improve the~     patient comfort and experience. The benefit of this practice has been widely demonstrated in~     adults, decreasing perioperative anxiety, postoperative pain scores as well as nausea and~     vomiting.~      In pediatric surgery, hypnosis is an effective technique for the management of preoperative~     anxiety. It is used by many teams in their daily practice, particularly during anesthetic~     induction.~      For 2 years, the team of pediatric anesthesia and surgery of the Montpellier University~     Hospital also offers for selected short and superficial non-invasive surgeries, an~     intraoperative management under hypnosis in association with ocal anesthesia as an~     alternative to general anesthesia. If this clinical practice of hypnosis is fully accepted~     and recognized in our intraoperative surgical unit, to date, no studies have evaluated the~     benefits of this technique compared to general anesthesia.~      The objective of the study is to compare the impact of these techniques (hypnosis vs. general~     anesthesia) on postoperative experiences of children (rehabilitation time, anxiety, pain,~     nausea and vomiting, negative behavioral disorders).~   "
81061|NCT02505867|"~     The purpose of this study is to evaluate the effect of in-hospital diagnosis and treatment of~     sleep disordered breathing (SDB) on post-discharge mortality and readmissions in-~     hospitalized patients with acute heart failure syndrome and reduced ejection fraction~     (HFrEF).~   "
81062|NCT02505854|"~     The purpose of this study is to evaluate whether contribute with weight loss and improvement~     of blood sugar and lipemia in obese women.~   "
81063|NCT02505841|"~     The transversus abdominis plane (TAP) block is a regional anesthetic technique for post~     operative pain control after abdominal surgical procedures. Its effectiveness in children~     undergoing laparoscopic appendectomy has not been demonstrated. The investigators evaluate~     its analgesic efficacy over the first 24 post operative hours.~   "
81064|NCT02505828|"~     The aim of this study is to find markers that could differentiate infectious and inflammatory~     arthritis. The investigators want to find markers by differential analysis by compare~     synovial fluids of septic and inflammatory arthritis. The investigators will use for this~     analysis, proteomics, cytokine dosage and monocyte typing by flow cytometry analysis. The~     investigators will use one marker or a score with biological and clinical data to~     discriminate arthritis of infectious and inflammatory etiology.~   "
81076|NCT02505672|"~     Nasopharyngeal carcinoma (NPC) is usually treated with chemoradiotherapy. While the effects~     of this treatment on cochlear function is well characterized, its effect on vestibular~     function is not well studied.~      In this study the investigators will study the vestibular function of 50 patients undergoing~     chemoradiotherapy for NPC both before and after treatment in order to better define its~     effects. All patients will undergo a validated questionnaire (dizziness handicap index),~     posturography, audiometry and vestibular-evoked myogenic potentials.~   "
81065|NCT02505815|"~     Postoperative cognitive dysfunction (POCD) is a disease with restricted cognitive memory~     function and intellectual skills, which occurs after surgery with and without anesthesia. The~     POCD strongly depends on patient's age and the surgical operation type. The anesthesia~     procedure plays a pivotal role as well and regarding the current knowledge it is still~     uncertain which technique matches the lowest risk. Elevated stress level accompanied with~     regional anesthesia procedures are accused to cause POCD in elderly patients. The~     investigators address the question weather regional or general anesthesia leads to a~     pronounced POCD in dependence of stress incidence.~   "
81066|NCT02505802|"~     Botulinum toxin A (BoNT-A) injections are widely used to treat spasticity after stroke.~     Although this treatment is effective on muscle tone improvement, its effect on gait and~     ability of daily living on early stage of stroke adults remains uncertain.The purpose of this~     study is to determine whether an early calf muscle injection of low dose BoNT-A in severely~     affected patients within 6 weeks after stroke could help to hold back disabling muscle~     spasticity and improve walking dysfunction.~   "
81067|NCT02505789|"~     In many countries, numerous steps are taken to minimize the risk of infection from transfused~     blood products. Typically, blood banking organisations will screen for an array of infectious~     pathogens as part of their quality control protocol. While transmission of these tested~     agents via transfusion has become exceedingly rare, the risk of transfusion-transmitted~     infections for which testing is not currently performed continues to be a concern. Among~     these untested infectious agents is Epstein-Barr virus (EBV, also known as human~     herpesvirus-4). Most notably, infection with this virus in transplant recipients can give~     rise to a malignant disorder called post-transplant lymphoproliferative disease (PTLD), a~     life-threatening complication which is due to the uncontrolled expansion of EBV-infected~     cells. It is also associated with other complications such as hepatitis, hemophagocytic~     syndrome, etc. in transplant population. It is recognised that EBV infection can occurred in~     transfused immune suppressed graft recipients but the origin of the viral infection is still~     a matter of debate. It is a known fact that the EBV already present in the recipient's blood~     can undergo reactivation due to immune suppression. However, because it is known to occur~     more frequently in patients who are EBV-seronegative at the time of transplant, it is also~     accepted that primary infection contracted via an infected graft can be a source of virus.~     The question we are seeking to answer is whether immune suppressed graft recipients can~     acquire primary EBV infection via transfusion of blood products. EBV is present in the blood~     of most adults and cases of EBV transfusion-related infection have been reported. Transplant~     populations are generally transfused with very large volumes of blood products and our recent~     pilot study supports the possibility that transfusion-related EBV infection can be~     transmitted to pediatric hematopoietic stem cell (HSCT) recipients (Trottier et al, 2012).~     The aim of this study is to analyse the risk of EBV transmission through blood product~     transfusion in pediatric allogeneic HSCT patients.~   "
81068|NCT02505776|"~     This is a post-marketing surveillance study in Japan that will evaluate the safety and~     patient satisfaction with GLASH VISTA™ (bimatoprost cutaneous solution 0.03%) in the~     treatment of hypotrichosis of the eyelashes.~   "
81069|NCT02505763|"~     The main objective of the study is to assess the cost-effectiveness ratio of two management~     strategies of pleurisy in adults : a strategy by systematic thoracic ultrasound versus a~     strategy without thoracic ultrasound.~   "
81070|NCT02505750|"~     The investigators propose to conduct a randomised study on cT2, cT3a-b tumours less than 5 cm~     using two different techniques of radiotherapy boost following neoadjuvant chemoradiotherapy~     (nCRT) (CAP45): EBRT (9 Gy/5 fractions) or CXB (90 Gy/3 fractions). The endpoint will be~     organ preservation at 3 years without non-salvageable local pelvic recurrence. The proof of~     this concept will be of most benefit for all patients but especially for the elderly who~     usually are not fit for or keen to undergo major surgery.~      The hypothesis of this study is to determine whether the addition of an endocavitary boost~     with CXB after standard treatment with nCRT, increases the chance of rectum and anus~     preservation by 20%-unites in early rectal adenocarcinoma without locally progressive disease~     (organ preservation in control arm 20%, in experimental arm 40%).~      Main objective To demonstrate that neoadjuvant chemoradiotherapy in combination with a boost~     given with CXB (Arm B) is superior to the same neoadjuvant therapy plus a boost with EBRT~     alone (Arm A) in terms of rectum (organ) preservation without non salvageable local disease~     at 3 years post treatment start, or permanent deviating stoma.~      Study Design Open-label, phase III, prospective, multi-centre, international, randomised 1:1,~     2 arm study designed to evaluate the efficacy of a CXB boost versus an EBRT boost.~   "
81071|NCT02505737|"~     There is a critical need for treatments that address depression and barriers to mental health~     care in Parkinson's disease (PD). This randomized-controlled trial will evaluate a 10-session~     telephone-guided cognitive behavioral self-help program (TH-CBT) for depression in PD (dPD).~     72 people with dPD (and their caregivers) will receive either TH-CBT plus enhanced usual care~     (INTERVENTION GROUP) or enhanced usual care only (CONTROL GROUP). Groups will be compared at~     baseline, midpoint, endpoint, and 1 and 6 months post-treatment. Participants assigned to the~     control group with have the opportunity to receive the experimental intervention (TH-CBT)~     after the data collection period (e.g., after the 6-month follow-up evaluation). Given the~     public health impact of improved depression treatment in PD, the knowledge to be gained may~     be significant and the project could directly impact clinical practice.~   "
81072|NCT02505724|"~     This single-blinded randomized controlled trial assesses the efficacy of peer-coaching to~     teach novice surgical faculty an advanced laparoscopic skill.~   "
81073|NCT02505711|"~     The aim of this study is to evaluate the potential of reducing young child undernutrition in~     low-income countries through an integrated program that trains women's groups in agriculture,~     nutrition, child care and hygiene.~   "
81074|NCT02505698|"~     Three-dimensional functional Metabolic Imaging (3D MIRA) is a new infrared imaging technology~     using the Real Imager 8 (RI8) developed by Real Imaging. This technology generates 3D~     metabolic maps of the breast and based on sophisticated machine learning technology, provides~     objective risk assessment for the presence of malignant tumor in the breast. The procedure is~     non-invasive, comfortable and does not involve ionizing radiation. It is based on acquiring~     infrared images of the breast. Those images are processed and analyzed by computers to~     provide the objective risk assessment.~      The technology is intended to be used as a screening tool for breast cancer and emerges as~     highly useful in women for whom screening mammography is sub-optimal, such as women with~     dense breast. 3D MIRA is unaffected by breast density and is therefore ideal for evaluating~     patients with mammographically dense breasts.~      Real Imaging is continuously developing the technology including image acquisition hardware~     and objective analysis of the imaging biomarkers. To further improve and optimize this novel~     metabolic imaging technology, Real Imaging will introduce an improved imaging device.~      The purpose of this clinical study is to collect more imaging data in order to establish~     superiority of the newer device over the previous one.~      The investigators hypothesize is that the new device will be at least as good as the previous~     one.~   "
81077|NCT02505659|"~     Anterior cruciate ligament (ACR) rupture is a common lesion of sportsmen that leads to~     functional deficits which are difficult to overcome. To prevent from an unfavorable~     evolution, patients can either get a non-surgical treatment or an ACR surgery, which is very~     common. Knee functional performance level could impact on the postoperative outcome and it's~     of common knowledge that early re-education after an ACR rupture improves knee functioning.~      Patients with an ACR rupture enrolled in this study will be randomized either in an~     experimental group (with preoperative reeducation) or in a control group (without~     preoperative reeducation). Both groups will then have post-operative re-education (40~     sessions) based on HAS recommendations.~      The main aim of this study is to assess the impact of preoperative re-education on knee~     functional performance 4 month after surgical reconstruction of an ACR.~      Secondary aims are to determine the impact of the 4-week preoperative re-education on knee~     functional performance after an ACR rupture, before surgery and 7 months after surgery.~      Functional performance, muscular strength, proprioception and anterior knee laxity will be~     measured at inclusion (V0), 4-5 days before surgery (V1), 4 month (V4M) and 7 months (V7M)~     after surgery. Lysholme-Tegner scoring and IKDC2000 questionnaire will be added to the~     previous assessments.~   "
81078|NCT02505646|"~     Purpose:~      Fluid responsiveness in a context of circulatory failure can be predicted by different way.~     Dynamic criteria such as pulse pressure variation, stroke volume variation during an~     end-expiratory occlusion maneuver or a passive leg raising have been reported to predict~     fluid responsiveness. Only aortic velocity peak variation measured with transthoracic~     echocardiography during mechanical ventilation has been reported to predict fluid~     responsiveness in children. Besides some physician use a maneuver of abdominal compression to~     predict fluid responsiveness in children with circulatory failure. This strategy has never~     been formally evaluated.~      The investigators will study the diagnosis accuracy of the stroke volume variation induced by~     an abdominal compression to predict stroke volume variation after 10 ml/kg fluid load in~     children with circulatory failure.~      Thirty-eight pediatric patients under eight years old in circulatory failure, for whom the~     attending physician has decided a fluid load will be included. Hemodynamic parameters:~     arterial pressure, heart rate, stroke volume measured with echocardiography; will be~     recorded. This data collection will be performed before, after abdominal compression and~     after a fluid load of 10 ml/kg.~      Patients will be aposteriori sorted in two groups: Fluid responders and Fluid non-responders.~     Fluid responders are defined as patients that show an increase greater than 15 % in stroke~     volume. The diagnosis ability of the Stroke volume variation after an abdominal compression~     to predict fluid responsiveness will be investigate and receiving operative characteristic~     (ROC) curve will be built. The correlation between the variation of stroke volume during~     abdominal compression and during the fluid load will be studied. Other parameters such as~     arterial pressure and heart rate will also be investigated.~   "
81079|NCT02505633|"~     Ultrasound-guided supraclavicular brachial plexus block (US-SCBPB) has been a generalized~     regional anesthesia in upper extremity surgery. It is performed just above the clavicle, in~     which the neural cluster formed by the trunks or divisions of the brachial plexus is situated~     superolateral to the subclavian artery (SA).~      In many approaches, corner pocket approach [deposit local anesthetic (LA) at the intersection~     of the SA, neural cluster, and the first rib] and cluster approach (direct deposit LA into~     the neural cluster after penetration of the sheath of brachial plexus) has been well known~     methods. And single or multiple injection techniques has been used with the above approaches.~   "
81080|NCT02505620|"~     Obstructive Sleep Apnea Syndrome (OSAS) is characterized by repeated episodes of airway~     obstruction while sleeping. Upper airway obstruction while sleeping leads to a dramatic~     decrease in oxygen saturation and to hypoxemia finally, in which consequence the patient~     rapidly awake. Clinical signs are sleepiness and functional cognitive deficits. The Gold~     standard therapy is continuous positive airway pressure ventilation during sleep. However,~     the success depends strongly to the patient´s compliance. Surgical treatment is an~     alternative option, which could be considered if clinical success failed. A comparison of the~     cognitive function of both therapies is not yet analyzed. The study addresses the question~     which of this treatment options is favorable regarding cognitive function and outcome.~   "
81081|NCT02505607|"~     Overactive bladder (OAB) is a common, chronic condition, characterized by urinary urgency,~     with or without urge incontinence, usually with frequency and nocturia. Treatment adherence~     is a major barrier to management of OAB and drug continuation is poor. Many factors may play~     a role in non-adherence to medication management of OAB including drug cost, side effects,~     and a lack of understanding of the disease and treatment process.Studies show that recall of~     disease information and treatment is often suboptimal. Literature shows that providing~     written materials is an efficacious way to aid in recall. Based on known poor adherence to~     OAB medication treatment and the clear role patient education methods have on patient~     information recall, the investigators believe that improvement of participant education~     through use of a OAB care plan will improve participant understanding and treatment~     adherence.~      Through this randomized trial, the investigators plan to evaluate whether implementation of a~     OAB Care Plan improves understanding of disease and treatment options, treatment success, and~     satisfaction.~      This is a prospective, randomized, controlled study of OAB counseling in new patients~     presenting to the Urogynecology offices of Hartford Hospital. All new patients with a~     diagnosis of OAB will be offered participation. All consenting participants will be~     randomized 1:1 to one of two groups: 1) Standard Care group or 2) Care Plan group. In the~     Standard Care group, participants will be counseled as the physician routinely counsels~     patients about OAB, in the Care Plan group, participants will be counseled a printed~     Overactive Bladder Plan of Care information sheet. At the end of the visit, the participant~     will complete a Baseline Survey. The Baseline Survey includes basic demographic information,~     a physician satisfaction survey, and a OAB knowledge survey. The participant will return for~     follow up as directed by the physician.~      At the follow up visit, participants in both groups will complete a Followup Survey. The~     Followup Survey will be completed before the participant sees the physician. The Followup~     Survey assesses OAB knowledge.~      Eight months after the baseline visit, each participant's chart will be reviewed for final~     data collection. If a participant progresses to a treatment method where she is satisfied and~     would like to remain, this will be documented.~   "
81082|NCT02505594|"~     Obstructive sleep apnea (OSA) is a common disorder with major cardiovascular sequelae. A~     recent study confirmed that OSA is associated with impaired exercise capacity and increasing~     OSA severity predicts worsening exercise capacity, which is a marker of potential increased~     cardiovascular risk. However, potential mechanisms of decreased exercise capacity caused by~     OSA remain unclear. Several pathophysiologic mechanisms of OSA have been proposed and~     investigators hypothesize that endothelial dysfunction leading to exercise-induced right~     ventricular dysfunction and associated pulmonary hypertension is the potential mechanism for~     impaired exercise capacity in OSA.~   "
81083|NCT02505581|"~     Routine antibiotics for the intravenous and oral prophylaxis of colorectal surgery will be~     used.~      Experimental group: Patients undergoing elective colorectal surgery that involves, colonic~     resection.~      The antibiotic prophylaxis in this group will be composed of:~      An oral antibiotic pattern of ciprofloxacin (750mg / 12h, 2 doses) and metronidazole (250mg /~     8h, 3 doses) the day before surgery.~      Control group: Patients undergoing elective colorectal surgery that involves, colonic~     resection.~      The antibiotic prophylaxis in this group will be composed of:~      An intravenous antibiotic pattern of cefuroxime 1g and metronidazole 1,5gr during anesthetic~     induction.~      In both groups a second intravenous dose of cefuroxime (750mg) will be administered if the~     intraoperative time elongates more than three hours or there is an intraoperative bleeding~     over 1000cc.~      There won´t be a placebo treatment. Subject compliance will be evaluated according to the~     usual practice in surgical care field~   "
81084|NCT02505568|"~     The purpose of this study is to evaluate the efficacy of infliximab in induction regimen by~     assessing the mean decrease in Disease Activity Index for intestinal Behcet's disease (DAIBD)~     score of 20 or more in participants with active intestinal Behcet's disease who are~     refractory to conventional therapies.~   "
81085|NCT02505555|"~     The purpose of this study is to summarize our experience with and to evaluate the feasibility~     of transvaginal four-dimensional hysterosalpingo-contrast sonography using SonoVue~     (4D-HyCoSy) for assessment of fallopian tubal patency, women attending the fertility clinic~     are recruited. All of the patients are tried to be examined with 4D-HyCoSy,some of who~     undergone laparoscopy and dye. Then the results of 4D-HyCoSy and lap and dye are compared.~     All of the patients will be followed up. The complications of 4D-HyCoSy will be evaluated and~     the pregnancy outcomes will be recorded.~   "
81086|NCT02505542|"~     Patients receive study drug for one year (Part A). If, after the initial run-in phase, a~     sustained remission is reached they will be randomly split into one of three dose groups for~     another year (Part B). The maintenance of the sustained remission will be analyzed.~   "
81087|NCT02505529|"~     The UNCODE Study seeks to better identify the neurological causes of muscle weakness~     associated with advancing age. The main study consists of 4 laboratory-based testing sessions~     that involve testing muscle strength and physical and cognitive function as well as a battery~     of tests to 1) quantify brain excitability (using non-invasive transcranial magnetic~     stimulation), 2) modulate brain excitability (using non-invasive transcranial direct current~     stimulation), 3) spinal motor nerve firing characteristics, and 4) brain structure and~     function characteristics based on magnetic resonance images of the brain. Additionally, three~     option sub-studies are also available for enrollment. The first is a genetics sub-study where~     a cheek swab will be used to examine associations between certain genes and the physiological~     and functional measures obtained from the main study. The other two sub-studies are~     interventions. The first sub-study is a progressive resistance exercise training study where~     study participants will undergo 12-weeks of exercise training (3x/wk) and at the completion~     of the exercise training the measures obtained in the main study will be re-assessed. The~     other sub-study is a mental imagery sub-study where subjects are randomly assigned to perform~     a mental imagery training program consisting of imaging strong muscle contractions and~     mobility tasks (5x/wk) or to serve as a control (i.e., to not modify lifestyle) for 6-weeks.~     At the completion of the respective intervention period the measures obtained in the main~     study will be re-assessed.~   "
81088|NCT02505516|"~     patients om metformin from diabetic clinic were checked for bladder cancer~   "
81089|NCT02505503|"~     Some people experience a cramp-like leg pain during walking that is relieved only by rest.~     This is called intermittent claudication (IC) and it is a common symptom of peripheral~     arterial disease. Patients with IC struggle to walk, which in turn lowers their quality of~     life.~      The intensity of IC pain experienced during walking depends on several factors, including the~     type of footwear worn. For example, non-supportive shoes may make the calf muscles work~     harder during walking, leading to earlier and more-severe symptoms of IC.~      A member of the research team has developed a shoe that reduces the work done by the~     lower-leg muscles during walking. Preliminary data indicate that, when wearing these~     unloading shoes, people with IC were able to walk further without pain as compared with~     when wearing a normal pair of shoes. The current project aims to provide further information~     on the usefulness and acceptability of these shoes.~      Forty people with IC will complete a set of three walking tests on two separate occasions;~     once whilst wearing the unloading shoes, and once whilst wearing some normal shoes. The~     participants will then be given a pair of unloading or normal shoes to wear for two weeks,~     after which we will collect information on how acceptable the shoes were to wear via a survey~     of all participants and one-to-one interviews with a subset of participants.~   "
81090|NCT02505490|"~     The purpose of the study is to investigate the effect of television viewing on liking of~     food.~   "
81091|NCT02505477|"~     The purpose of this study is to attempt to treat cognitive and negative symptoms of~     schizophrenia, with the nutritional supplement N-acetylcysteine (NAC).~      Schizophrenia is a chronic mental disorder that affects approximately 65 million people~     worldwide, and causes significant disability and suffering. Patients with schizophrenia often~     hear voices and have persecutory delusions. Though these are the most recognizable features~     of the illness, the deficits most closely linked to disability are known as cognitive~     deficits and negative symptoms. Cognitive abilities refer to the ability to perform mental~     tasks that require focus and attention, and also include memory and verbal skills. Negative~     symptoms refer to a lack of interest in the world, and decreased social interactions. In our~     study, the investigators aim to improve these symptoms and deficits by targeting the~     glutamate system.~      Glutamate is the major excitatory neurotransmitter in the brain, and its regulation is~     abnormal in schizophrenia: glutamate levels are too low at some receptors, and too high at~     others. As well, free radicals surrounding glutamate receptors also interfere with their~     proper function. N-acetylcystine (NAC) is a safe and widely-available dietary supplement that~     may restore glutamate to its correct levels in the brain, and may also help protect the brain~     from antioxidant damage.~      In our study, patients with schizophrenia will be randomly assigned to receive either NAC or~     placebo for 8 weeks. Brain levels of glutamate and an important antioxidant, glutathione,~     will be measured before and after treatment, using a neuroimaging technique known as magnetic~     resonance spectroscopy. Cognitive and negative symptoms will also be assessed before, during~     and after treatment. The investigators hypothesize that glutamate and glutathione will be~     normalized in patients' brains, and that their negative and cognitive symptoms will be~     improved, too.~   "
81092|NCT02505464|"~     The focus of this research is to create a repository of ultrasonographic images and their~     corresponding medical data from pregnant women (the mothers of the fetuses that are imaged),~     focusing on fetal anomalies. These women will visit the obstetrical clinics at Regional One~     Health and the Le Bonheur Fetal Center.~   "
81099|NCT02505373|"~     Objective~      Attempted suicide is the main risk factor for repeated suicidal behavior. However, evidence~     of the effectiveness of follow-up treatments for these patients is limited. The authors~     evaluated the effectiveness of the Attempted Suicide Short Intervention Program (ASSIP), a~     novel brief therapy based on a patient-oriented model of suicidal behavior. The ASSIP~     consists of three sessions followed by regular letters for 24 months.~      Method~      In this treatment study, 120 patients were randomly assigned to either the ASSIP intervention~     or a control group that received a one-session clinical assessment. Both groups received in-~     and outpatient treatment as usual. Study participants also completed a set of psychosocial~     and clinical questionnaires every 6 months during a 24-month follow-up period.~   "
81197|NCT02504099|"~     The purpose of this study is to evaluate the safety and efficacy of~     ombitasvir/paritaprevir/ritonavir (OBV/PTV/r), with or without dasabuvir (DSV) coadministered~     with or without ribavirin (RBV) for 12 or 24 weeks in adult patients with genotype 1 or~     genotype 4 chronic HCV infection and treated early stage Hepatocellular Carcinoma with~     compensated cirrhosis.~   "
81093|NCT02505451|"~     Summary.~      Theoretical Rationale:~      The left ventricular myocardial performance results from a complex interplay between linear~     deformations (longitudinal, circumferential and radial) and twist/ untwist mechanics. These~     components of myocardial mechanics can be assessed, at rest and during stress conditions, by~     high resolution echocardiography using the 2D-strain technology and constitute good indexes~     of tissue intrinsic contractility / relaxation properties. Type 2 diabetes (T2DM) and~     metabolic syndrome (MS) are associated with an increased risk for cardiac diseases. While~     several clinical studies have reported, particularly in T2DM, a diastolic dysfunction~     (concept of diabetic cardiomyopathy), the existence of impaired regional myocardial~     function, with altered intrinsic contractility properties, remains largely unanswered,~     especially in the SM. Stress echocardiography is very interesting to reveal myocardial~     dysfunction, discrete or absent at rest. To the best of our knowledge, no scientific study~     is, however, today available on the kinetics of linear strains and twist/untwist dynamics in~     response to stress in T2DM as well as SM. The epicardial adipose tissue is the source of~     production of important pro-inflammatory cytokines that have the potential, through an~     exacerbation of oxidative stress, to impair coronary endothelial function, increase fibrosis,~     but also directly affect cardiomyocyte calcium homeostasis. An increase in epicardial adipose~     tissue is consensually reported in T2DM and SM and is clearly associated with coronary~     atherosclerosis. A link between cardiac adiposity and overall cardiac function, particularly~     diastolic, is now suggested but to our knowledge no study has challenged its association with~     myocardial dysfunction in T2DM as SM patients.~      Objectives and Methodology: - To investigate regional myocardial linear deformations and~     torsion, at rest and in response to a dobutamine stress, in asymptomatic T2DM and SM patients~     without clinical complications, - to study the links between expected regional myocardial~     abnormalities and inflammation, hyperglycemia and cardiac adiposity. A control group of~     healthy individuals matched for sex and age will also be included.~      All the subjects will benefit from a clinical, anthropometric and biological evaluation. In~     addition, conventional echocardiography (remodelling and global diastolic and systolic~     functions) complemented by a functional analysis by tissue Doppler imaging will be performed.~     Furthermore, 2D cine loops will be recorded in the apical 4, 3 and 2- chamber views for the~     objective assessment of myocardial longitudinal deformations as well as in the parasternal~     short axis (base and apex) for the evaluation of the circumferential deformations and basal~     and apical rotations and left ventricular torsion, at rest and under low dose of dobutamine~     (110 and 120 bpm).~   "
81094|NCT02505438|"~     Maintaining muscle mass and function is important in healthy ageing to maintain quality of~     life. Loss of muscle mass is major problem, as beyond the age ~50, muscle mass declines by~     ~1-2% a year. To prevent this loss, the investigators need to understand the mechanism~     regulating muscle mass as we age. In this project the investigators aim to determine these~     mechanisms using a new technique of heavy water ingestion, this allows measurement of~     multiple aspects of skeletal muscle mass metabolism e.g. protein synthesis, over long periods~     (6 weeks) as people go about their normal everyday activities. The investigators also aim to~     determine the influence of resistance exercise training on older muscle, as well as~     differences between men and women in muscle responses to exercise and nutrition HMB~     (beta-hydroxy-beta-methylbutyrate).~   "
81095|NCT02505425|"~     Advanced heart failure affects nearly 6 million Americans, and less is known about how this~     illness affects the 80% of heart failure patients who are 65 years and older because research~     tends to focus on younger patients. Older patients with heart failure and their family~     caregivers, rarely have access to palliative supportive care services because the disease is~     unpredictable and palliative treatment may not be provided until after other medical~     treatments have been tried. Investigators are studying whether palliative care provided when~     advanced heart failure patients are still well will result in better quality of life, mood~     and less symptom distress compared to usual or standard heart failure care.~      Specific Aims and Hypotheses:~      Specific Aim 1: Determine whether ENABLE: CHF-PC leads to higher advanced heart failure~     patient-reported quality of life (QOL) and mood (depression/anxiety); and lower symptom~     burden and resource use (e.g. hospital admissions and days, emergency visits) at 8 and 16~     weeks after baseline.~      • Hypothesis 1: Intervention participants will experience higher QOL and mood, and lower~     symptom burden and resource use at 8 and 16 weeks after baseline compared with those~     receiving usual HF care.~      Specific Aim 2: Determine whether ENABLE: CHF-PC leads to higher caregiver-reported QOL, mood~     (anxiety/depression), and self-reported health and lower caregiver burden at 8 and 16 weeks~     after baseline.~      • Hypothesis 2: Intervention caregivers will report higher QOL, mood, and self-reported~     health, and lower caregiver burden at 8 and 16 weeks after baseline.~   "
81096|NCT02505412|"~     Subtle myocardial deformation abnormalities in asymptomatic nf-1 patients: is cardiac~     screening needed?~   "
81097|NCT02505399|"~     Rotational atherectomy (RA) prior to angioplasty is the reference treatment for highly~     calcified atherosclerotic coronary lesions. It aims at fragmenting calcium deposits into~     microscopic particulates to allow less hazardous coronary revascularization and stenting. The~     main drawback associated with the procedure is the subsequent enhancement of platelet~     aggregation which promotes the distal embolization of micro-thrombi and atherosclerotic~     fragments. In order to limit these complications, a double antiplatelet therapy is required~     (generally Clopidogrel + Aspirin) when RA procedures are performed. Clopidogrel inhibits the~     protein P2Y12 which is a cornerstone in platelet aggregation. Ticagrelor is a new~     antiplatelet agent that provides faster and greater P2Y12 inhibition than Clopidogrel. It is~     currently indicated to reduce risk of cardiovascular events in patients hospitalized for~     coronary revascularization after an acute coronary syndrome. Ticagrelor has never been~     evaluated so far in stable coronary patients treated with rotational atherectomy prior to~     angioplasty.~   "
81098|NCT02505386|"~     In geriatric departments, physicians are faced with two difficulties, first the increasing~     number of infections caused by multiresistant bacteria, especially extended spectrum~     β-lactamase (ESBL) producing enterobacteria strains and second, the poor venous access~     frequently encountered in elderly population. Giving antibiotics subcutaneously would be an~     interesting alternative, all the more as intramuscular injection is contraindicated in case~     the of anticoagulant therapy. Unfortunately, few data are available about subcutaneous (SC)~     administration. Ertapenem is a recent long-acting parenteral carbapenem indicated especially~     in the treatment of ESBL infection. Its subcutaneously administration has been tested in~     several studies in Intensive Care Units (ICU) and internal medicine wards with promising~     results regarding clinical and pharmacokinetics data.~      An alternative to the IV Ertapenem administration is needed because of poor venous access and~     behavioural abnormalities commonly present in infected elderly population. Ertapenem is~     currently SC administrated in geriatric departments if no other option is available. Moreover~     elderly patients often present several comorbdities, polymedication, renal insufficiency,~     cachexia which may disturb antibiotics pharmacokinetics.~      The aim of the study is to obtain pharmacokinetic data of SC and IV Ertapenem administration~     in elderly population, obtain PK/PD parameters adapted to time-dependent antibiotics (T%>MIC)~     and descriptive data of occurrence of adverse effects and evolution of signs of infection.~   "
98053|NCT02283788|"~     A randomized, double-blind, placebo-controlled and open label active-controlled, 4 period~     crossover trial to evaluate the effect of eslicarbazepine acetate on cardiac repolarization~     in healthy adult men and women~   "
81100|NCT02505360|"~     We seek to compare biochemically and histologically the nasal cartilage and ear in the~     newborn cleft lip and slot carrier in order to improve the quality of care and patient~     comfort after surgery of cheilorhinoplasty which is the primary treatment slots .~      The concentration of hyaluronic acid as well as in type 1 collagen and 3 are assayed by~     immunohistochemistry and study of mRNA and then they are compared according to the type of~     cartilage.~      This comparison is done on nasal cartilage samples and atrial newborns holders of cleft lip~     and operated in the neonatal period.~      Given the difficulty and constraint of time it takes to reach the 20 subjects of our study ,~     we will also add to our population the stillborn babies before 25SA and newborns who die~     before the age of 28 days and having had an autopsy.~   "
81101|NCT02505347|"~     Distal biceps ruptures occur most commonly among young males in their third and fourth decade~     of life. These injuries are becoming more common, however, as the aging population is~     remaining active through sport or labour demands. Distal biceps tears or ruptures follow a~     heavy eccentric load being placed on a shortened or flexed muscle, and often require surgical~     repair. Functionally, distal biceps injuries cause impairment as this portion of the muscle~     is largely responsible for supination and flexion at the elbow. Currently there is no~     consensus regarding post-operative immobilization protocols, and little evidence is available~     regarding timeframe for early return to functional activities. Existing evidence on~     functional outcomes post distal biceps tendon repair (DBTR) is of low quality with small~     sample sizes, and no known RCTs exist comparing early mobilization to immobilization on~     functional return. Reported timeframes for immobilization range from early controlled motion~     on day 1 post-operatively to complete immobilization for 6 weeks.~      The primary study goal is to determine the effect of immobilization compared to unrestricted~     mobility post DBTR on early functional return to activities. It has been previously reported~     that those with DBTR related to a workers compensation injury returned to full duties in 3.95~     months, while those with a non-workers compensation related injury returned to full work~     duties in 1.35 months. In Alberta, near 100 WCB claims were made for DBTR in both 2013 and~     2014. Early mobilization of these repairs may allow an earlier return to modified and full~     work duties, thereby improving the functional quality of life of the individual as well as~     reducing the overall cost of disability payments.~      This study will assess the 1) time to return to pre-injury work level and 2) time to return~     to modified duties among those who have no movement restriction post-repair and those who are~     splinted for 6 weeks. Re-rupture rates between groups will also be assessed as will strength,~     range of motion (ROM) and quality of life. These findings will assist in developing a~     standardized protocol for immobilization to optimize functional and clinical outcomes while~     expediting return to work.~   "
81102|NCT02505334|"~     This trial is conducted in Asia. The aim of the trial is to compare the efficacy and safety~     of liraglutide 1.8 mg/day to liraglutide 0.9 mg/day in Japanese subjects with type 2 diabetes~     mellitus.~   "
81103|NCT02505321|"~     The adipose (fat) cells under the skin are where individuals store excess fat. The more~     excess fat they have, the more strain they put on these cells which then get bigger and~     don't work as well as they should. Having some fat under the skin is important. People who~     have a genetic defect which results in them having almost no fat under their skin have a very~     high risk of a condition called insulin resistance (where the body does not respond as well~     to insulin and blood sugar levels rise). This can lead to diabetes and heart disease despite~     them not being overweight.~      Scientists have only recently started to understand the importance of fat in insulin~     resistance and how people unable to store fat very well can have insulin resistance despite~     not being obese. The investigators have also recently discovered that small changes in a~     person's genetic code (their body's instruction manual) may also affect their ability to~     store fat and would like to explore this in more detail. To do this, they will recruit~     volunteers from the Exeter 10,000 study who gave permission to contact them about further~     research. The investigators will collect detailed body size measures and blood samples taken~     before and after a special drink that is high in fat (similar to a thick milk shake), then~     compare the results between people with and without the particular genetic changes of~     interest.~      Knowing more about these genetic changes and how fat cells work could help to improve~     understanding about why some people develop diabetes and heart disease despite a relatively~     normal BMI.~   "
81104|NCT02505308|"~     Defects in insulin secretion are central to the pathogenesis of type 2 diabetes (T2D) but the~     molecular basis and physiological consequences of those defects are poorly understood,~     impeding efforts to develop novel therapeutic approaches. Key questions remain unanswered,~     such as the extent to which T2D-associated islet dysfunction reflects endogenous defects in~     beta-cell mass or function, as opposed to disruption of external factors impinging on the~     beta-cells, such as incretins.~      Recently the investigators have identified several genetic variations (DNA changes)~     associated with the production and processing of insulin in non-diabetic individuals and now~     aim to explore in more detail the role of these genetic variations. Utilising a recruit by~     genotype approach, they will identify individuals with and without genetic variants of~     interest from existing databases of research volunteers. The investigators will collect~     detailed medical history and measurements, fasted and stimulated blood samples for the~     profiling of insulin-related hormones and metabolites. The resulting genetic and non-genetic~     data will be used to improve understanding of the role of genetic variation on insulin~     secretion and sensitivity defects that lead to the development of T2D.~   "
81105|NCT02505295|"~     Selenium is a trace element essential to human health.Selenium protection against cellular~     damage by oxygen radicals is accomplished through selenoproteins. Ischemic stroke is~     associated with the generation of oxygen free radicals resulting in a condition of oxidative~     stress. Supplementing stroke patients with antioxidant nutrients may improve survival.~   "
81106|NCT02505282|"~     Postural hypotension is common in older people, leading to falls, decline in function, and~     dependence. Available treatments have limited efficacy and tolerability; novel approaches to~     treatment are therefore needed. Decreased vascular health, stiffening of the arteries and~     consequent decreased vascular reactivity are thought to contribute to postural hypotension~     and are therefore therapeutic targets.~      Recent trial evidence has suggested that vitamin K may exert beneficial effects on vascular~     health particularly in respect to inhibiting calcification. Calcification increases vascular~     stiffness, decreases compliance and thus decreases the ability of blood vessels to~     autoregulate blood pressure and flow - which could contribute to postural drops in blood~     pressure. Worsened vascular health could also impact adversely on baroceptor function, which~     is needed for blood pressure autoregulation and which is disrupted in patients with~     orthostatic hypotension.~      Vitamin K intake is below recommended daily intake in 60% of adults in the UK. In animals,~     vitamin K supplementation may be able to reverse calcification of arteries, and in humans~     Vitamin K has been shown to arrest decline in carotid artery elasticity compared to placebo.~     High levels of circulating vitamin K were also associated with lower levels of CRP in the~     Framingham cohort, suggesting a possible role in the suppression of chronic inflammation that~     is known to accompany vascular disease. The recent ECKO study suggested that vitamin K may~     reduce falls and fractures; an intriguing question that follows on from this is whether this~     could be due to beneficial effects on vascular health and postural hypotension, leading to~     less dizziness and reduced falls.~      This cross-sectional comparative study aims to find whether there is a difference in the~     vitamin K status of patients with postural hypotension compared to those without postural~     hypotension and whether differences in vitamin K status are associated with other markers of~     vascular function in patients with and without postural hypotension. This could potentially~     lead to new treatments for the condition for which there is currently little of proven~     benefit.~   "
98248|NCT02281227|"~     To evaluate the effects of skin compression with an indicator at the needle entry point on~     radiation exposure time of fluoroscopically guided transforaminal epidural block in obese~     patients~   "
81107|NCT02505269|"~     Limited stage Hodgkin lymphoma is a highly curable disease, but standard treatment with ABVD~     chemotherapy and radiation can lead to late risks of secondary cancers, lung injury, heart~     injury, and others. This trial eliminates radiation therapy and reduces intensity of~     chemotherapy by incorporating the highly active FDA-approved targeted therapy brentuximab~     vedotin, an antibody-drug conjugate specifically against the lymphoma cells, combined with~     the standard chemotherapy drugs Adriamycin and Dacarbazine (AD).~   "
81108|NCT02505256|"~     Hyperplasia of Mammary Glands is a complex disease, and there is no consensus or guideline~     for the treatment of this disease. This study was launched to investigate into the problem~     that which patients should be diagnosed as hyperplasia of mammary glands and which patients~     should be treated.~   "
81109|NCT02505243|"~     The aim of this study is to evaluate RBV plasma concentrations when used in combination with~     newly developed DAA combinations. If possible, its correlations with SVR rates and incidence~     of anaemia will be assessed in HCV-patients.~   "
81110|NCT02505230|"~     This study will investigate the energy consumed from an entree with high- or low-volume~     vegetables incorporated into the entree or served along side of the entree, in normal weight~     adults.~   "
81111|NCT02505217|"~     Treatment of patients who have had a heart attack with drugs that prevent formation of blood~     clots has been shown to reduce the patient's risk of subsequent cardiovascular events such as~     heart attack, stroke, and death. Because new drugs have increased treatment options, the~     development of tests that can guide treatment should improve treatment selection and further~     reduce the risk of cardiovascular events as well as bleeding. This study is designed to~     assess the value of new tests. It is a prospective study that will enroll patients who have~     had a heart attack. Blood will be taken during hospitalization for a heart attack (1 day~     after their heart attack) and a second time 6 months later during an ambulatory clinical~     visit. Investigators will perform biochemical tests on the blood that assess the likelihood~     of making blood clots. One tablespoon of blood will be taken at each time. Taking this amount~     of blood poses no risk to the participant. Investigators will ask the participant whether~     they have had bleeding or cardiovascular events during the initial evaluation, the ambulatory~     follow-up at 6 months, and during a telephone interview 1 year after enrollment. During their~     1 year of participation, investigators will review medical records and record information in~     a manner that protects the identity of all participants. We hypothesize that the biochemical~     test results will be similar at baseline and 6 month follow-up and that these biochemical~     tests will identify patients at greater risk of cardiovascular events and bleeding. Treatment~     of participants will not be altered by their participation in this study.~   "
81112|NCT02505204|"~     Paravertebral block (PVB) combined with light intravenous sedation was associated with a~     short hospital stay, less post-operative nausea and vomiting and reduced analgesic~     consumption compared to general anesthesia for ventral hernia repair. Given the effectiveness~     of PVB in the ventral hernia repair, it would be beneficial to study the effect of PVB with~     versus without clonidine in elderly patients.~      Patients will be randomly allocated to one of 2 groups with 30 patients in each, using the~     sealed envelope technique. Group one will receive PVB with clonidine while group 2 will~     receive PVB with placebo.~   "
81113|NCT02505191|"~     A pilot phase I, randomised, open mono-center, two parallel group clinical trial~     investigating the pharmacokinetics of a prolonged-release formulation in comparison to an~     immediate-release formulation of St. John's wort extract Ze 117 in healthy male volunteers~     under fasting condition.~   "
81114|NCT02505178|"~     This study seeks to determine the feasibility and efficacy of a Problem Solving Therapy~     intervention for the treatment of late life depression (LLD). Participants diagnosed with LLD~     will participate in six sessions of Problem Solving Therapy, a form of talk-therapy, over a~     period of eight weeks. A Case Manager (CM) will lead the PST. The primary outcome measure is~     depression severity and will be measured throughout the study at weeks 0, 4, and 8. the~     secondary outcome measure is quality of life and will be measured at week 0~     (pre-intervention) and week 12.~   "
81115|NCT02505165|"~     The purpose of this study is to test the efficacy of a clinic-based intervention designed to~     reduce illness uncertainty for parents of children who have been recently diagnosed with~     cancer.~   "
81116|NCT02505152|"~     To evaluate the values of percutaneous transhepatic intrahepatic portosystemic shunt for~     treatment of portal vein occlusion with symptomatic portal hypertension after splenectomy.~   "
81117|NCT02505139|"~     A circulating tumor cell (CTC) count is an established prognostic factor in some malignancies~     such as metastatic breast cancer. However, the value of CTC in diagnosis and outcome~     prediction of metastatic nasopharyngeal carcinoma (mNPC) patients is not unknown. Through the~     observational prospective clinical trial, sensitivity, specificity, positive and negative~     predictive values of CTC in diagnosis of mNPC patients will be gained. Further, the value of~     CTC in outcome prediction of mNPC patients will be uncovered.~   "
81118|NCT02505126|"~     The study evaluates the efficacy of 1 week of tDCS (5 sessions) placebo in reducing alcohol~     consumption within the 24 weeks following the treatment in non-abstinent patients with~     alcohol use disorders versus placebo.~   "
81119|NCT02505113|"~     To observe the etiology, diagnosis, management and prognosis of cavernous transformation of~     portal vein.~   "
81127|NCT02505009|"~     Background and aims: Nucleos(t)ide analogues may suppress HBV DNA to undetectable level, but~     only about 30-40% remain sustained response 1-3 years after discontinued therapy. The~     investigators will try to improve the sustained response rate by given a course of HBV~     vaccination during the last 6 months on patients receiving a 3-year entecavir or tenofovir~     therapy.~      Rational: The host may response to HBV vaccine when HBV DNA and immune tolerance are~     suppressed during entecavir or tenofovir therapy.~      Patients: Patients who have been receiving entecavir or tenofovir therapy for at least 30~     months will be invited to this study. The case group will receive 5 Engerix-B injections~     during the last 6 months of entecavir or tenofovir therapy. Arm A-entecavir pretreated group:~     75 cases will be enrolled to receive Engerix-B injection and compared with histological~     non-vaccine treated controls; Arm B-tenofovir pretreated group: 50 patients will be~     randomized into case (vaccine) and control group according to age, gender, pretreatment HBV~     DNA level.~      Therapy: Both case and control groups will receive a 3 year or longer entecavir or tenofovir~     therapy. Patients will be screen at 24-30 months and enrolled at 30 months after entecavir or~     tenofovir therapy. They will receive 5 Engerix-B injections at 0,1st ,2nd,3rd and 6th month~     [30-36 +/-1 month post nucleos(t)ide therapy] post enrollment. Both drugs will be~     discontinued after completed therapy.~      Follow-up: Both groups will be monitoring by biochemistry, alpha-fetoprotein, quantitative~     HBsAg, HBV DNA levels and immunological parameter periodically for 2 years after therapy.~      Efficacy: Those patients with persistent normal ALT and HBV DNA lower than 1*100000 cps/mL~     after discontinued nucleos(t)ide analogues therapy will be considered to have sustained~     response. Patients with transient elevation of HBV DNA and ALT, but normalized spontaneously~     without further therapy will be defined as delayed response. Patients with persistent HBV DNA~     greater than 1*100000 cps/mL will be considered to have non-sustained response.~      Study duration: The enrollment will be completed in one year and keep on observation for~     additional 2 years.~      Expected goals of the study: HBV vaccine and nucleos(t)ide analogues combination therapy may~     decrease the HBV relapse rate at 1 and 2 year after completed therapy.~   "
81120|NCT02505100|"~     The threat of premature birth (MAP) is the leading cause of hospitalization during pregnancy~     complicated by preterm delivery in 5-10% of cases in developed countries. Psychological~     stress that encompasses anxiety and anxiety resounding including sleep quality can be a work~     of preacher and premature delivery.~      Preterm birth before 37 has an impact on the survival and health of the newborn. It is the~     leading cause of mortality and obstetric complications. It has a cost both for the newborn,~     the term parturient health but also the financial cost by the management before delivery and~     the consequences of a premature birth.~      The usual management of MAP is hospitalized with tocolysis, monitoring and rest. The~     hospitalization and invasive procedures contribute to increasing stress. It therefore seems~     necessary to seek to diversify and master reputable techniques for their effectiveness on~     mastering stress and improving sleep quality as hypnosis and feel relaxing.~      Hypnosis in obstetrics is used primarily to control pain, nausea and postpartum depression.~     It also reduces preoperative anxiety and during induction of anesthesia, as well as~     behavioral disorders during the first postoperative week. Hypnosis can play an important role~     in the prevention of preterm birth. In a non-randomized study, hypnosis combined with drug~     therapy has prolonged pregnancy of patients followed in high risk pregnancy.~      The relaxing touch brings relaxation and well being. In obstetrics, it has an influence on~     the anti-stress hormones and plays a role in reducing pain during childbirth.~      Few studies interested in hypnosis and relaxation therapies in pregnant women, especially in~     case of MAP. The published data relate to a small number of patients and a low level of~     evidence. Although there seems promising results, prospective studies are needed to conclude~     its effectiveness in improving the stress, pain or other parameters.~      Health workers trained in these techniques could observe during their production improved~     sleep disorders, stress, better communication between doctor and patient. Moreover, these~     treatments could induce an improvement in the overall care of patients, and therefore have an~     impact on the continuation of pregnancy.~      These findings are based on these hypothesis. There is a clinical gain the contribution of~     hypnosis and relaxing touch in women hospitalized for MAP before 32 weeks of gestation. This~     would, among other improvements in sleep disorders and stress, decrease pain, and acting on~     the extension of the term of pregnancy in women followed by these techniques and a decrease~     in hospitalizations of newborns premature neonatology and neonatal intensive care units.~   "
81121|NCT02505087|"~     The objective of this study is to determine whether the administration of N-acetylcysteine~     (NAC) improves oxidative stress. To determine this, the study will assess the impact of oral~     treatment on the balance between reduced and oxidized form of glutathione in erythrocytes of~     peripheral blood.~   "
81122|NCT02505074|"~     The Melody valve has historically been used for pulmonary valve replacements; however it has~     been more recently used in the mitral and tricuspid positions. This multi-center,~     retrospective, observational study will review the durability of the Melody valve inserted~     into the mitral or tricuspid positions.~      Patients who have undergone Melody valve insertion into either the mitral or tricuspid~     positions prior to December, 2014 will be eligible for the study. Basic de-identified patient~     demographics will be collected as well as select clinical data. Ventricular function and~     valvar function of the affected valve will be retrospectively reviewed both prior to surgery~     and following, as well as review of operative data. The investigators will also review the~     most recent follow up data and any subsequent re-interventions on the Melody valve. Data from~     all sites will be entered into an external REDCap database, using only de-identified data.~   "
81123|NCT02505061|"~     The four purposes of this study are: 1) to examine the feasibility of providing children with~     disabilities to explore the environment with a modified ride-on car; 2) to quantify whether~     children with disabilities are able to have more social interactions with a ride-on car; 3)~     to examine the progression of socialization during the intervention and follow-up phases to~     determine which factors might influence the learning curve; 4) to compare the effectiveness~     of using the modified toy cars through the hospital-based program and regular therapy program~     after intervention and follow-up phases to determine the critical factors on increasing~     independent mobility and socialization, including motivation, treatment executor, treatment~     environment and play programs. It can provide guidelines for the future intervention.~      Independent mobility is believed to be essential for perceptual-motor, cognition, language~     and social skill development. It is important to increase the independent mobility in~     children with disabilities and further enhance their development, especially motor and~     socialization. Assistive and power mobility devices allow children with disabilities to move~     independently within their environment and may increase the opportunities to explore and~     interact with people and environment . However, issues to consider before prescribing an~     assistive device include factors such as age, accessibly to community environments, cost,~     social acceptance of the device and the adaptability of the device to growth. This study is~     to use the customized, modified ride-on toy cars, to enhance the independent mobility,~     exploration and socialization through low-cost, family-centered approach. It will also~     improve family's understanding of children's capabilities, which improve their development.~     Investigators will recruit 60 children with who are between 1 to 3 years old and diagnosed as~     motor delay (>1.5 sd). They will be randomly assigned to one of the following two groups:~     hospital-based program group and regular therapy group.~      The whole study duration will be 18 weeks, including 9-week intervention and 9-week~     follow-up; the total amount of treatment will be equal for two groups. The hospital-based~     program will be administered by the therapist and include 120 minutes/per session, 2~     sessions/per week. In addition, the research team will visit the hospital once/per week to~     provide assessments. The regular therapy group will continue their regular therapy without~     any additional car driving training. The research team will visit them once/per week for the~     assessments. The assessments include behavior coding from the videotapes and the clinical~     assessments. The findings of this study will help to understand the feasibility and~     effectiveness of using the low-tech modified toy cars on advancing children's mobility and~     socialization. They can be used in the clinics and are a low cost alternative or addition to~     other mobility devices. They may provide a novel therapeutic tool to improve mobility,~     socialization and development.~   "
81124|NCT02505048|"~     The purpose of this study is to assess the efficacy of a PARP inhibitor, rucaparib, in~     progressing breast cancer patients and who are carrying a BCRAness profile defined by genomic~     signature or BRCA 1 or 2 somatic mutation, without known BRCA 1 or 2 germline mutation.~   "
81125|NCT02505035|"~     This is a large pragmatic, randomized controlled trial to test the real-world effectiveness~     of inpatient palliative care consultative services in improving a number of patient- and~     family-centered processes and outcomes of care among seriously ill hospitalized patients. The~     investigators hypothesize that improved patient-centered outcomes can be achieved without~     higher costs by simply changing the default option for inpatient palliative care consultation~     for eligible patients from an opt-in to an opt-out system. To test this hypothesis the~     investigators will conduct a clinical trial at 11 hospitals using the same electronic health~     record within Ascension Health, the largest non-profit health system in the U.S.~   "
81126|NCT02505022|"~     During this study the investigators will 1) collect measures of social cognition and social~     functioning in adolescents and young adults who are experiencing early symptoms of a major~     mental disorder; and 2) evaluate the predictive value and utility of a new role functioning~     assessment measure for individuals experiencing changes in their lives after an index episode~     of mental illness. This will happen in the context of providing treatment-as-usual to~     individuals who arrive seeking help with the early phases of mental illness.~   "
81128|NCT02504996|"~     Siatalgia is one of the main symptoms related to emergency department presentations. Patients~     with sciatalgia are seeking for immediate pain relief and little known regarding the pain~     management of these patients in emergency department. This study aim to trial the effect of~     intravenous paracetamol and morphine in patients presented with sciatalgia to emergency~     department.~   "
81152|NCT02504684|"~     Objective: Compare venous occlusion rates at a one-year follow-up comparing 1920-nm versus~     1470-nm laser treatment. Design: Non-randomized prospective study. Methods: Adult patients~     with varicose veins associated with great saphenous reflux were included. Procedures were~     performed between February and April of 2013. The 1470-nm laser ablation was performed in~     continuous mode, power being set between 8 and 10 W, while for the 1920-nm it was set between~     5 and 6 W. Checking for vein closure was performed during the thermal ablation procedure,~     LEED (linear endovenous energy density) being calculated after the procedure. Follow-up data~     were collected at the 7-day, 30-day, 3-month, 6-month and 1-year visits, and involved~     clinical and ultrasound evaluation, measurement of occlusion extent.~   "
81129|NCT02504983|"~     Transcatheter arterial chemoembolization (TACE) + sorafenib therapy has been demonstrated to~     exert a beneficial effective on time-to-tumor-progression (TTP) in patients with unresectable~     hepatocellular carcinoma (HCC) in some studies. However, the beneficial effect varies among~     studies conducted in different areas of the world. The objectives of this study are (1) to~     understand whether GALNT14 TT genotype patients respond better than do GALNT14 non-TT~     genotype patients when treated by TACE; and (2) to understand whether GALNT14 non-TT genotype~     patients can benefit from TACE plus sorafenib (Nexavar) combination therapy. Patients~     enrolled will be stratified by GALNT14 genotyping. The GALNT14 non-TT patients were then~     randomized into two subgroups to evaluate the safety, tolerability and efficacy of TACE plus~     sorafenib therapy.~      The primary endpoint of this study is the efficacy of TACE with or without sorafenib~     combination therapy evaluated by complete remission (CR).~      The secondary endpoints are:~        1. Time to partial or complete response (PR + CR).~        2. Time-to-tumor-progression (TTP) and the progression free survival (PFS).~        3. Overall survival (OS).~        4. Safety and tolerability of TACE plus sorafenib therapy.~   "
81130|NCT02504970|"~     The Anesthesia Quality Institute (AQI) is home to the National Anesthesia Clinical Outcomes~     Registry (NACOR), a data warehouse that has been designated as a Qualified Clinical Data~     Registry (QCDR) by the Centers for Medicare and Medicaid Services (CMS) for Physician Quality~     Reporting System (PQRS) reporting. With 20 million cases and growing, Anesthesia Quality~     Institute's clinical data provides an evidence-based rational that informs treatment choices~     and helps control treatment costs.~      National Anesthesia Clinical Outcomes Registry is intended for all anesthesia providers~     caring for patients. The registry provides participating providers with:~      Custom continuous performance monitors Performance gap analysis and patient outlier~     identification Access to improvement interventions to close performance gaps including~     patient care management tools, targeted education, resources and other evidence based~     interventions Registry and peer-to-peer benchmarks~   "
81131|NCT02504957|"~     Photodynamic therapy (PDT) is a palliative treatment for malignant biliary obstruction. The~     aim of this study is to assess the feasibility and safety of this technique in the context of~     a nationwide retrospective analysis.~   "
81132|NCT02504944|"~     The aim of the present study is to evaluate the safety and efficacy of propranolol 0.2% eye~     drops in treating preterm newborns with a precocious stage of retinopathy of prematurity~     (ROP). Preterm newborns (gestational age 23-32 weeks) with a stage 1 ROP will receive~     propranolol 0.2% eye drops treatment until retinal vascularization will be completed, but no~     more than 90 days.~      Propranolol concentrations will be measured on dried blood spots at the steady state (10th~     day). Cardiovascular and respiratory parameters will be continuously monitored. Blood~     samplings checking metabolic, renal and liver functions will be performed periodically, as~     well as cardiac function, in order to verify the treatment safety. Serial ophthalmological~     evaluations will be planned to monitor the efficacy of the treatment, the ROP progression and~     the possible complications.~   "
81133|NCT02504931|"~     The investigators propose to conduct a clinical trial to evaluate sertraline treatment~     efficacy in a large sample of military veterans with a dual diagnosis of PTSD and Alcohol Use~     Disorder who are receiving Cognitive and Behavioral Therapy as part of the VA-system's new~     dual diagnosis program. The study is designed as an efficacy trial of sertraline used as an~     adjunct to Cognitive Behavioral Therapy (CBT) in the treatment of PTSD/Alcohol dual~     diagnosis. There are two outcomes of interest, namely PTSD symptom improvement and also~     decreased alcohol consumption. The investigators are interested to know whether or not~     sertraline is superior to placebo in improving the symptoms of either one or both of these~     two disorders. Even though sertraline is a treatment of choice for PTSD, the investigators~     expect that the comorbid condition of alcohol dependence will complicate the treatment of~     PTSD and that the clustered subgroups will show differential treatment response with~     sertraline. The primary objective of the present study is to identify subgroups of alcohol~     dependent persons with PTSD who will either benefit or not benefit from treatment with~     SSRI's. The proposed study will enroll veterans with PTSD and dually-diagnosed alcohol~     dependence in a 12-week treatment providing sertraline vs. placebo medication as an adjunct~     to manualized CBT and will specifically test the hypothesis that subtypes of alcohol~     dependence can be used to predict which patients respond well and which subgroup responds~     poorly to SSRI treatment.~   "
81134|NCT02504918|"~     Background:~      - The disease malaria can cause very serious health problems. Researchers want to see if~     malaria affects the way T cells and vaccines work in the body. If it does, they may need to~     give malaria treatments before vaccines. They want to check the T cells in children who do or~     do not get antimalarial treatment.~      Objectives:~      - To study the effect of blood stage malaria on T cell suppression and vaccine responses. To~     describe markers of T cell suppression in children who do or do not receive antimalarial~     treatment.~      Eligibility:~      - Children ages 12 59 months living near Ouelessebougou in Mali. They must have no serious~     illness.~      Design:~        -  Participants will be screened with medical history and physical exam.~        -  Some participants will get a course of antimalarial tablets. Some will not. This will be~          decided at random.~        -  Participants will have monthly visits for up to a year. They will have blood tests at~          each visit.~   "
81149|NCT02504723|"~     Gastric variceal obturation is the current endoscopic therapy of choice for gastric variceal~     bleeding but is associated with a high rebleeding rate. Carvedilol is a potent non-selective~     β-blocker. The role of carvedilol in the prevention of recurrent gastric variceal bleeding is~     not studied. This study aimed at evaluating the efficacy of carvedilol as an adjunct to~     gastric variceal obturation in the secondary prophylaxis of gastric variceal bleeding.~   "
81150|NCT02504710|"~     This study will try to analyze the effect of the real-time kinematic feedback (KRTF) to learn~     manual therapy on peripherical joints comparing the results with the traditional teaching~     method.~   "
81235|NCT02503605|"~     Biosimilar drug marketing of recombinant FSH for the treatment of infertility is another step~     in simplifying fertility treatments, making them easier to manage and more accessible to~     patients. Taking in mind these arguments ,the study is proposed for determining equivalence~     in terms of biological effectiveness of an ovarian stimulation protocol with biosimilar~     recombinant FSH stimulation protocol vs. urinary FSH in oocyte donation program.~   "
81135|NCT02504905|"~     Background:~      - People with dystonia have muscle contractions they can t control. These cause slow,~     repeated motions or abnormal postures. People with dystonia have abnormalities in certain~     parts of the brain. Researchers want to study the activity of two different brain areas in~     people with writer s cramp and cervical dystonia.~      Objective:~      - To compare brain activity in people with dystonia to that in healthy people.~      Eligibility:~        -  Right-handed people ages of 18 60 with cervical dystonia or writer s cramp.~        -  Healthy volunteers the same ages.~      Design:~        -  Participants will be screened with a physical exam. They will answer questions about~          being right- or left-handed.~        -  At study visit 1, participants will:<TAB>~        -  Have a neurological exam.~        -  Answer questions about how their disease impacts their daily activities.~        -  Have a structural magnetic resonance imaging (MRI) scan. Participants will lie on a~          table that can slide <TAB>in and out of a metal cylinder. This is surrounded by a strong~          magnetic field.~        -  Do 2 simple computer tasks.~        -  At study visit 2:~        -  Participants will have transcranial magnetic stimulations (TMS) at 2 places on the head.~          Two wire <TAB>coils will be held on the scalp. A brief electrical current creates a~          magnetic pulse that affects brain <TAB>activity. Muscles of the face, arm, or leg might~          twitch. Participants may have to tense certain muscles or do simple tasks during TMS.~          They may be asked to rate any discomfort caused by TMS.~        -  Muscle activity in the right hand will be recorded by electrodes stuck to the skin of~          that hand.~   "
81136|NCT02504892|"~     Background:~      - Research has shown that the drug everolimus can stop cancer cells from growing. It is~     approved for people with advanced kidney cancer. Researchers want to see if it also helps~     people with two other types of kidney cancer.~      Objective:~      - To see if everolimus is safe and effective in people with Birt-Hogg-Dube Syndrome~     (BHD)-associated kidney cancer or sporadic (nonfamilial) chromophobe renal cancer.~      Eligibility:~      - People ages 18 and over with BHD-associated kidney cancer or advanced sporadic chromophobe~     renal cancer.~      Design:~        -  Participants will be screened with:~        -  Medical history, physical exam, and blood and urine tests.~        -  Computed tomography (CT) scan or magnetic resonance imaging (MRI) scan. They will lie in~          a machine that takes pictures of their chest/abdomen/pelvis.~        -  They may also be screened with:~        -  Another scan, of the brain or neck.~        -  Bone scan.~        -  Positron emission tomography scan with fludeoxyglucose (FDG-PET).~        -  Heart and lung tests.~        -  Tests for hepatitis.~        -  Participants will take a tablet once a day by mouth for up to a year. They will keep a~          diary of when they take the tablet and any symptoms.~        -  During the study, participants will have physical exams and urine and blood tests. They~          will have scans of the chest/abdomen/pelvis. They may have FDG-PET and bone scans.~        -  Participants will have tests for hepatitis and may have a tumor sample taken.~        -  Participants will have a follow-up visit 4 5 weeks finishing taking the drug. They will~          have a physical exam and blood tests. They may have scans and/or hepatitis tests.~        -  Participants will be called about every 3 6 months after the study ends to see how they~          are doing~   "
81137|NCT02504879|"~     Background:~      - The rare disease melorheostosis causes bones to thicken. This may lead to pain, and can~     affect bones, joints, and muscles. Researchers want to learn more about the disease and how~     it progresses.~      Objective:~      -To see what happens to people with melorheostosis over time and understand the causes of the~     disease.~      Eligibility:~        -  People 18 and over with melorheostosis.~        -  Their unaffected relatives.~      Design:~        -  All participants will have a medical history and physical exam.~        -  Participants who are relatives will give samples of blood or cheek cells.~        -  Other participants will be in the study for about 1 week.~        -  They will have blood and urine collected.~        -  Strength, walking, and range of motion will be measured.~        -  Participants may also have~        -  X-rays and scans.~        -  A pain and neurological evaluation.~        -  Their skin evaluated by a dermatologist.~        -  A small sample of bone taken.~        -  Nerve conduction studies. Small electrodes with to wires will be put on the skin. A~          metal probe will give a small electrical shock.~        -  Electromyography. A thin needle will be placed into the muscles.~        -  An ultrasound, which uses sound waves to examine the muscles and nerves. An ultrasound~          probe will be placed over the skin.~        -  A bone scan. They will get a small amount of radioactive fluid through a needle in an~          arm vein. This fluid travels to the bones. The bones will be photographed in a machine.~        -  Bone Densitometry, a low-level x-ray.~        -  Photographs taken.~        -  A small circle of skin removed with a surgical instrument.~        -  Questionnaires about their quality of life.~        -  Participants will be asked to return about every 2 years. At these visits, participants~          may have blood and urine tests and x-rays.~   "
81138|NCT02504866|"~     Background:~      - Traumatic brain injury (TBI) often causes problems with moving and balance, and thinking~     and emotions. Exercise can improve these things in people with other brain damage.~     Researchers want to look at the effect of exercise on these things in people with TBI.~      Objectives:~      - To study how head injuries affect the brain. To study if exercise can help some symptoms in~     people with TBI. These include problems thinking, balancing, and moving, and depression or~     anxiety.~      Eligibility:~        -  People age between 18 and 79 :~        -  Had a non-penetrating TBI at least 12 months ago.~        -  Are physically inactive, but can stand and walk without help.~      Design:~        -  Participants will be screened with medical history, physical exam, and blood and urine~          tests. They may have a balance test.~        -  Participants will be assigned to a high-intensity or a lower-intensity exercise program.~        -  The study is 6 months long. There will be 3 months with exercise on an elliptical~          machine and 3 months without exercise.~        -  Participants will exercise for 30 minutes on an elliptical machine, 3 days per week for~          3 months.~        -  Participants will also have 3 outpatient testing visits lasting approximately 8 hours,~          once every 3 months. This visit will include:~        -  Blood tests~        -  Tests for memory, attention, and thinking~        -  Tests of walking and balance~        -  Questionnaires~        -  An MRI: they will lie in a machine that takes pictures of their brain, while breathing~          regular air and air with more carbon dioxide~        -  Test of physical fitness.~   "
81151|NCT02504697|"~     The goal of this project is to improve lung cancer screening in high-risk individuals by~     identifying biomarkers of preclinical disease and disease risk that are measured in minimally~     invasive and non-invasive biospecimens. Existing biomarkers for lung cancer diagnosis as well~     as new biomarkers discovered specifically in this clinical setting will be examined.~     Biomarkers that identify individuals at highest risk for being diagnosed with lung cancer~     prior to the appearance of concerning symptoms could increase the utility of lung cancer~     surveillance and the efficiency of lung cancer chemoprevention clinical trials. Achieving~     these goals would improve the detection and treatment of early stage and incipient lung~     cancer, while restricting the risk of these procedures to those individuals who currently~     exhibit the early molecular warning signs of impending disease.~   "
81139|NCT02504853|"~     Background:~      - About 15 million Americans have a food allergy. Because there are no cures or effective~     prevention or treatment for food allergies, researchers want to learn more about them.~      Objective:~      - To learn more about the causes and effects of food allergy and related conditions.~      Eligibility:~        -  People ages 2 99 who have food allergy and/or a related genetic or other condition~        -  Their relatives~        -  Healthy relatives and volunteers~      Design:~        -  Participants will have at least 3 visits over 1 2 years, and then once a year for up to~          12 years. Each may last a day or longer.~        -  Participants will be screened with medical history, physical exam, and questionnaires.~        -  Participants may have the following:~        -  Blood tests~        -  Allergy skin prick tests: Drops of allergens are placed on the back or arm. The skin is~          scratched under each drop.~        -  Leukapheresis: blood is taken from a needle in one arm, passed through a machine, and~          returned through a needle in the other arm.~        -  X-rays~        -  Esophageal string test: One end of a string is taped to the cheek and the other end is~          packed into a capsule. When the capsule is swallowed, the string unwinds; it is left in~          for at least 1 hour.~        -  EGD and colonoscopy: Biopsies are taken from the gastrointestinal system.~        -  Tiny biopsies of skin~        -  Photographs of the body~        -  Collection of cells through:~        -  Swab of nose, inside of cheek, or skin~        -  Gentle skin scrape~        -  Tape stripping: piece of tape is put on the skin and pulled off.~   "
81140|NCT02504840|"~     Background:~      - Magnetic resonance imaging (MRI) has been used for decades to help diagnose and monitor~     neurological disorders like multiple sclerosis (MS). Researchers want to improve how MRI~     pictures are taken. They also want to learn more about using newer MRIs with stronger magnets~     to get better pictures than standard MRIs provide.~      Objectives:~      - To collect data that will help researchers better understand MS and related diseases.~      Eligibility:~        -  Adults 18 and older with MS or MRI findings that appear similar to MS, or with other~          neurological diseases that may look or act like MS.~        -  Healthy adult volunteers.~      Design:~        -  Participants will be screened with a review of their medical records.~        -  Participants will have a baseline visit. It will include a physical exam, medical~          history, and neurological exam. They may have blood tests.~        -  The study will last indefinitely.~        -  Participants may have MRIs. Some MRIs may include a contrast dye. For this, a needle~          will be used to guide a thin plastic tube into an arm vein.~        -  Participants may have up to 2 lumbar punctures per year. Skin will be numbed and a~          needle inserted between back bones will remove fluid.~        -  Participants may give saliva samples and have an eye exam.~        -  Participants may have evoked potential tests. These measure how the nervous system~          responds to different types of stimulation. Participants may sit in front of a TV and~          watch pictures on the screen. Or they may wear earphones that make a clicking noise or~          static. Or they may get a small electrical shock that may tingle and cause a hand or~          foot twitch.~        -  Participants may have tests of strength, spasticity, sensations, balance, and/or~          walking.~   "
81141|NCT02504827|"~     The purpose of this research study is to characterize the pharmacokinetics of intravenous~     ceftazidime/avibactam in patients with Cystic Fibrosis.~   "
81142|NCT02504814|"~     The study explores the changes in pressure, volume and in hypercapnia in patients with COPD~     and ILD. The investigators will use different application forms.~   "
81143|NCT02504801|"~     To test the hypothesis that nebulized Pulmicort Respules could reduce post operation~     pulmonary complication incidence in primary lung cancer patients with COPD. Compare~     post-operation pulmonary complication incidence in two treatment arms among primary lung~     cancer patients with COPD required single lobectomy from 3days before operation to 7 days~     after operation.~   "
81144|NCT02504788|"~     Whole brain radiotherapy (WBRT) has long been a practical and effective therapeutic modality~     for various settings of management in radiation oncology. For example, the indications for~     WBRT should include brain metastasis or metastases, the setting of prophylactic cranial~     irradiation (PCI) used mainly for patients with limited-stage small cell lung cancer, and~     even some patients with extensive-stage small cell lung cancer. The rationales for WBRT are~     essentially based on that it can target both microscopic and gross intracranial disease.~      In addition to providing rapid alleviation of neurologic symptoms and enhanced intracranial~     disease control, WBRT might also prolong the time to develop neurocognitive function (NCF)~     decline. However, paradoxically NCF decline can also occur due to a sequel of WBRT. In terms~     of the time course of WBRT-induced NCF decline, it might vary considerably according to the~     specific domains which are selected to be measured. Early neurocognitive decline occurs~     within the first 1 - 4 months after WBRT for brain metastases. The domains of early~     neurocognitive decline principally involve verbal and short-term memory recall.~      Since several decades ago, it has been understood that hippocampus plays an essential role in~     memory function. Not little evidence supports that radiation-induced damage to hippocampus~     should be strongly associated with NCF impairment. Furthermore, several studies have shown~     that isodose distribution in hippocampus is closely related to neurocognitive function in~     patients with benign or low-grade brain tumors. As a consequence, it is hypothesized that~     conformal hippocampal sparing during the course of WBRT (HS-WBRT) might provide significant~     preservation in terms of cognitive function.~      This prospective cohort study aims to explore and evaluate the impact of the delivery of~     HS-WBRT on the pattern of NCF change and the extent of NCF decline in patients receiving~     prophylactic or therapeutic WBRT. As compared with previous related and relevant studies, it~     will also be investigated whether neurocognitive functional preservation can be achieved via~     the integration of hippocampal sparing with the course of WBRT.~   "
81145|NCT02504775|"~     This will be a monocentric, single blinded, randomized, single-dose, two-periods,~     two-sequence, crossover bioequivalence study of two oral formulations in healthy participants~     under fasting conditions.~   "
81146|NCT02504762|"~     To evaluate whether an HCR strategy is more or less effective than conventional coronary~     artery bypass grafting (cCABG), in diabetic patients with multivessel CAD involving the left~     anterior descending artery (LAD), who do not present in the context of acute ST-elevation~     myocardial infarction (STEMI).~   "
81147|NCT02504749|"~     This study aims to compare the time to regain intestinal motility after general anesthesia~     versus spinal anesthesia for cesarean section.~      A double blinded randomized controlled trial was conducted at the Department of Obstetrics~     and Gynecology, Kasr El-Aini Teaching Hospital, Faculty of Medicine, Cairo University, Cairo,~     Egypt, between July 20 and November 20, 2015. In the study hospital, the total number of~     deliveries in 2012 was 15 167, 6244 (41.2%) of which were by cesarean; in 2013, the total~     number of deliveries was 16 057, 5200 (32.4%) of which were by cesarean.~   "
81148|NCT02504736|"~     To evaluate the effect of colesevelam on LDL levels and A1c in high-risk , dysglycemic South~     Asians (with diabetes, and/or with CAD and concomitant metabolic syndrome) whose LDL remains~     above target despite optimal statin use.~   "
81153|NCT02504671|"~     This is a randomised, Phase IIb, dose-adaptive, multicentre, double-blind, parallel group,~     placebo-controlled study with the primary objective to assess the efficacy of GSK3196165, in~     combination with methotrexate (MTX), in subjects with active moderate severe rheumatoid~     arthritis (RA) despite treatment with MTX. Approximately 210 subjects will be randomised into~     the study, following a screening period of up to four weeks. The total treatment period is up~     to 52 weeks, with a 12-week follow-up period after the last dose (Week 50). Subjects will be~     randomised (1:1:1:1:1:1) to placebo or one of five subcutaneous (SC) GSK3196165 doses, in~     combination with MTX (at a weekly dose between 15-25 milligram [mg]), previously received for~     at least 12 weeks, with a stable and tolerated dose and route of administration for >=4~     weeks. Escape therapy is provided at specified timepoints in the protocol for subjects that~     do not achieve adequate disease improvement.~   "
81154|NCT02504658|"~     This 4-week pilot study is designed to test the feasibility, adherence, and effectiveness of~     a cell phone text message program for lifestyle goal setting among adolescents with type 1 or~     type 2 diabetes. The study entails a small-scale randomized controlled trial with pre-post~     test of a mobile text message program.~   "
81155|NCT02504645|"~     This current Phase 3 study will evaluate the efficacy and safety of administration of~     subcutaneous (sc) IPP-201101 in patients with active SLE.~   "
81156|NCT02504632|"~     Study of platelet activation by severe aortic stenosis and its correction by Transcatheter~     Aortic Valve Implantation (TAVI)~   "
81157|NCT02504619|"~     CordIn™ is a cryopreserved stem/progenitor cell-based product of purified CD133+ cells~     composed of ex vivo expanded allogeneic UCB cells. The overall study objectives are to~     evaluate the safety and efficacy of CordIn™.~   "
81158|NCT02504606|"~     This clinical trial was evaluated to compare the safety and pharmacokinetics of Besylsartan~     with Amosartan, which was available commercially after single oral dose in healthy male~     subjects.~   "
81159|NCT02504593|"~     The investigators propose to implement a new mobile interface that automatically reads and~     troubleshoots malaria rapid diagnostic test (RDT) cassettes. This device, called a Deki~     reader (DR), will allow the investigators to establish an extensive quality assurance program~     of malaria diagnosis performed by trained community health volunteers (CHVs). The study will~     lease 10 DRs and rotate them amongst 200 CHVs performing community-based malaria diagnosis~     through rapid diagnostic testing. The study setting is Bungoma East subcounty and Kiminini~     subcounty in Kenya. The overall goal is to measure and improve the quality of malaria~     diagnosis by CHVs using malaria RDTs. The investigators aim for every CHW to exceed 90%~     sensitivity and specificity and zero operator errors within six months. There are no~     appreciable risks to the CHV associated with evaluation by the DR device. The investigators'~     analysis will focus on descriptive statistics of RDT use and accuracy amongst all~     participating CHVs.~   "
81160|NCT02504580|"~     A Phase 2, Randomized, Pilot Study to Investigate the Safety, Efficacy, Pharmacokinetics and~     Bioavailability of HTX-011, HTX-002, or HTX-009 Administered Via Injection and/or Topical~     Application Following Unilateral Open Inguinal Herniorrhaphy~   "
81161|NCT02504567|"~     This protocol aims at assessing the efficacy of performing catheter ablation for atrial~     fibrillation (AF) with laser catheters versus performing it with radiofrequency (RF)~     catheters. In order to study laser catheter ablation efficacy, MRI analysis of the lesions 3~     months after the procedure will be performed in both groups. MRI analysis will detect~     ablation gaps in the lesions encircling pulmonary veins. The primary endpoint will compare~     the number of gaps in the laser catheter and the RF group. The secondary endpoint of the~     study is recurrence of AF after 12 months. The target population of the study is patients~     with paroxysmal or persistent AF undergoing AF ablation.~   "
81162|NCT02504554|"~     This is an open-label clinical trial to investigate a combination therapy for treating~     gastrointestinal problems in children with autism spectrum disorders.~      The combination therapy includes beneficial bacteria.~   "
81163|NCT02504541|"~     Evaluation of safety of a concentration controlled testosterone enanthate QuickShot~     Testosterone regimen administered subcutaneously once each week to adult males with~     hypogonadism.~   "
81164|NCT02504528|"~     The purpose of this study is to establish the methodology of bronchial provocation tests with~     house dust mites in China, and to evaluate its safety and effects on upper and lower airways~     inflammation.~   "
81165|NCT02504515|"~     Patients will be randomly assigned to two separate groups. Both patient groups will be~     evaluated using the WHOQOL-BREF questionaire. Evaluations will be carried out just before the~     study begins and at intervals of six months during a period of one year for a total of three~     evaluations. Group one will be made up of patients who will begin homeopathy or acupuncture~     or anthroposophic medicine treatment and patients from group two will start homeopathy or~     acupuncture or anthroposophic medicine six months after the beginning of the study. Each one~     of these three research branches will be done independently (Homeopathy versus control;~     Acupuncture versus control; Anthroposophic Medicine versus control). Conventional medical~     treatment will be available for all patients in both groups. A data sheet will be filled out~     on each patient with data as to age, education level, marital status and the patient's own~     perception of their health status. During the interviews the interviewer will have no~     influence whatsoever over the respondents' answers. Integrative/complementary or traditional~     medicine doctors do not participate in the research and will not be informed about which~     patients are participating in this project, and as such the research will be blinded for~     these doctors. Minitab software, version 16, was used for sample calculation through the~     module Power and Sample Size. Sample calculation option for paired t-tests before and after~     intervention demonstrated the need to randomize 906 patients: 450 patients for homeopathy~     branch (225 patients in the homeopathy group and 225 patients in the control group), 228~     patients for acupuncture branch (114 patients in the acupuncture group and 114 patients in~     the control group), and 228 patients for anthroposophic medicine branch (114 patients in the~     anthroposophic medicine group and 114 patients in the control group).~   "
81166|NCT02504502|"~     Current lab reports are designed to communicate results from the laboratory to the provider;~     they are not designed to be accessible to patients. The investigators believe that a new type~     of genomic test report, tailored for patient- as well as provider-use, will enable patients~     to have access to information they can understand allowing them to be more involved in the~     management of their disorders, better navigate the health care system, and make more informed~     decisions about their health and health care in conjunction with their providers. This~     approach has the potential to improve outcomes from both the patient and provider~     perspectives.~      The investigators propose to study the research question, Can a genomic laboratory report~     tailored for both providers and families of patients improve interpretation of complex~     results and facilitate recommended care by enhancing communication and shared decision~     making?~   "
81572|NCT02499224|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and~     maximum tolerated dose (MTD) of YYB101, HGF-neutralizing humanized Mab, in advanced solid~     tumors patients who are refractory to standard therapy.~   "
81167|NCT02504489|"~     To compare the overall survival of NSCLC patients receiving 2nd- or 3rd-line systemic therapy~     with docetaxel + plinabulin (DP Arm) to patients treated with docetaxel + placebo (D5W) (D~     Arm) for advanced or metastatic disease.~      Secondary purposes of the study are:~        -  To compare the neutropenia (incidence of Grade 4 neutropenia [absolute neutrophil count~          (ANC) < 0.5 × 10^9/L]) on Day 8 (+/- 1 day) of Cycle 1), DoR, neutrophil count on Day 8~          (+/- 1 day) of Cycle 1, incidence of docetaxel dose reduction and/or docetaxel dose~          withheld in Cycle 2 due to neutropenia in Cycle 1, QoL (EORTC QLQ-C30 [item 30, average~          overall quality of life over all observable weeks]), ORR, and PFS in patients with NSCLC~          treated in the DP Arm to patients treated in the D Arm as 2nd- or 3rd-line therapy for~          advanced or metastatic disease.~        -  To compare the safety and adverse events profile of the DP Arm to D Arm.~        -  To compare dose intensity of docetaxel (percent dose administered compared to dose~          assigned) between the 2 treatment arms.~        -  To evaluate population pharmacokinetics in patients enrolled in the Western countries~          and China.~   "
81168|NCT02504476|"~     The purpose of this study is to find out the time it takes to absorb, distribute, breakdown~     and remove the drug from the body in healthy participants and subjects with schizophrenia and~     whether it causes any side effects.~   "
81169|NCT02504463|"~     This study will determine the pharmacokinetics (PK) of [14c]-samidorphan in healthy male~     volunteers.~   "
81170|NCT02504450|"~     To review records of patients treated with antipsychotics (including Adasuve, Geodon, Haldol)~     in order to evaluate outcomes.~   "
81171|NCT02504437|"~     The purpose of the present study is to evaluate the efficacy of the preconditioned autologous~     bone marrow mesenchymal stem cells for patients with ischemic heart diseases.~   "
81172|NCT02504424|"~     This study is designed to allow existing investigators continued access to the AeroForm~     Tissue Expander to treat patients while AirXpanders completes a marketing application and~     during the review process by FDA.~   "
81173|NCT02504411|"~     The purpose of the study is to compare the efficacy of device assisted colonoscopy (DAC) with~     standard colonoscopy (SC) in detecting adenomas in a randomized fashion.~   "
81174|NCT02504398|"~     Vaccine injections are a significant source of pain for infants. Altering the injection speed~     when administering vaccines may be an effective intervention and is feasible (cost neutral).~     At present, there are no data regarding impact of injection speed on vaccine injection pain~     in infants. The aim of this study is to address this knowledge gap and to compare the impact~     of slow and fast vaccine injection speeds on pain during routine infant vaccinations.~   "
81175|NCT02504385|"~     The subjet of this study is to explore the effect of using virtual reality environment at the~     clinic and at home (using Timocco) on the motor and participation abilities of children with~     DCD (Developmental Coordination Disorder).~      The study will examine the efficacy of using virtual reality gaming environment (Timocco) for~     treating children with DCD and the use of remote therapy, by shifting the focus of therapy~     from the clinic to the home environment, using the remote control system of Timocco for home~     practice.~   "
81176|NCT02504372|"~     In this study, participants with Stage IB/II-IIIA non-small cell lung cancer (NSCLC) who have~     undergone surgical resection (lobectomy or pneumonectomy) with or without adjuvant~     chemotherapy will be treated with pembrolizumab or placebo. The primary study hypothesis is~     that pembrolizumab will provide improved disease-free survival (DFS) versus placebo.~   "
81177|NCT02504359|"~     This phase Ib trial studies the side effects of combination chemotherapy and donor stem cell~     transplant followed by ixazomib citrate maintenance therapy in treating patients with~     multiple myeloma that has returned after a period of improvement and is likely to recur (come~     back), or spread. Giving chemotherapy before a donor peripheral blood stem cell transplant~     helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem~     cells) and cancer cells. When the healthy stem cells from a donor are infused into the~     patient they may help the patient's bone marrow make stem cells, red blood cells, white blood~     cells, and platelets. Giving ixazomib citrate after the transplant may improve the overall~     treatment outcome without causing additional toxicities.~   "
81178|NCT02504346|"~     Phase II, single-arm study to assess the safety and efficacy of AZD9291 (80 mg, orally, once~     daily) in second-line (or later) patients with EGFR mutation-positive, locally advanced or~     metastatic NSCLC, who have progressed following treatment with an approved epidermal growth~     factor tyrosine kinase inhibitor agent.~   "
81179|NCT02504333|"~     The purpose of this study is to assess the safety and efficacy of nab-paclitaxel (Abraxane)~     and gemcitabine followed by modified FOLFOX (AG-mFOLFOX) in patients with previously~     untreated, metastatic pancreatic adenocarcinoma~   "
81180|NCT02504320|"~     This study will assess the relative bioavailability, safety and tolerability following~     administration of 80 mg single oral doses of 4 febuxostat extended release (XR) formulations.~   "
81181|NCT02504307|"~     Prospective, single center, randomized and non-inferiority study, to include up to 60~     patients with de novo coronary artery disease. Patients will be followed at 30 days, 3, 6 and~     12 months. At 3 months all patients will be submitted to angiographic and OCT evaluation.~   "
81182|NCT02504294|"~     A phase 3b study for subjects receiving Epogen to compare a dosing algorithm between Hospira~     Epoetin and Standard of Care Epogen.~   "
81183|NCT02504281|"~     To determine whether there is higher incidence of skewed X chromosome inactivation(SXCI) in~     the recurrent miscarriage(RM) population compared with normal population, and screen the~     possible genetic sites that may lead to SXCI and RM by genome microarray analysis of the RM~     patients with SXCI and normal females with SXCI.~   "
81184|NCT02504268|"~     The purpose of this study is to determine if abatacept is effective in the treatment of early~     rheumatoid arthritis.~   "
81194|NCT02504138|"~     Renal ischemia/reperfusion (I/R)-induced injury is known to be associated with immediate and~     long-term hepatic dysfunction after liver transplantation. Protecting the liver against I/R~     injury and maintaining hepatic function during transplant surgery is therefore very important~     in order to improve post-operative outcome. This purpose of this study is to investigate~     whether propofol anesthesia done in both liver donors and recipients during living-donor~     liver transplantation is effective in reducing liver I/R injury via its antioxidant and~     antiinflammatory properties and improve post-transplant outcome compared to desflurane~     anesthesia.~   "
81185|NCT02504255|"~     Crohn disease (CD) usually evolves by surges interspersed by periods of unpredictable~     remission. the probability of recurrence of CD in a patient in remission is even stronger if~     it pre-exists endoscopic lesions of the intestinal mucosa.~      The mucosal healing exploration needs the realization of an ileo-colonoscopy under general~     anesthesia which is an invasive procedure, restrictive and expensive, thus prohibiting its~     too frequent repetition. we do not currently have noninvasive and reliable markers able to~     predict the occurrence of thrust of CD and allow the introduction of a more suitable~     treatment.~      Indeed, relapse prevention is the best way to avoid complications and formation of lesions~     that lead to the irreversible medical treatment failure and surgery.~      Since during the CD, it is the immunological changes that lead to inflammation and lesions,~     we make the assumption that the ability of certain markers immunological to predict a relapse~     of CD is higher than that of other in particular inflammatory markers.~      This work should help to identify the profile of patients with CD in remission but at high~     risk of recurrence. It will specify i) the potential new markers immunological, from the~     pre-clinical research, predict the onset of a recurrence of CD ; ii) the predictive interest~     of different inflammatory markers used in routine or during the CD evaluation ; iii) Finally,~     the stress and the management of stressful events in the occurrence of a relapse.~      This work also will specify the evolution of different markers at the moment of thrust~   "
81186|NCT02504242|"~     A Randomized, Subject-Assessor Blind, Multi-center, Comparative Clinical Trial to evaluate~     the efficacy and safety of Inject BMP in Patients Undergoing Transforaminal Lumbar Interbody~     Fusion.~   "
81187|NCT02504229|"~     This study evaluates the therapeutic effects of autologous dendritic cells co-cultured with~     cytokine-induced killer cells (DC-CIK) combined with S-1 ((Tegafur, Gimeracil, and Oteracil~     Potassium) and oxaliplatin adjuvant chemotherapy in locally advanced unresectable or~     metastaticgastric cancer. Half of participants will receive DC-CIK combined with S-1 and~     oxaliplatin adjuvant chemotherapy,while the other half will receive S-1 and oxaliplatin~     adjuvant chemotherapy served as controls.~   "
81188|NCT02504216|"~     The purpose of study is to test whether rivaroxaban added to standard of care treatment, when~     compared to placebo, has the potential to reduce the incidence of the clinical events related~     to the clots and complications of the heart and brain (CV death, MI, or stroke) or the legs~     (acute limb ischemia or major amputation) in patients who had undergone recent procedure(s)~     to improve the blood flow of their legs.~   "
81189|NCT02504203|"~     The purpose of this study is to determine whether BCG vaccination shortly after birth can~     reduce early infant mortality in a rural and an urban setting.~   "
81190|NCT02504190|"~     Lymphoma is a malignant blood disease sensitive to chemotherapy. In case of relapse after~     first-line treatment, high-dose chemotherapy conditioning followed by autologous~     hematopoietic stem cell transplantation (auto-HSCT) improves patient survival and reduces the~     risk of relapse. Auto-HSCT may also be indicated in the first line in case of aggressive~     lymphoma at high risk of relapse. BEAM (Carmustine, Etoposide, Aracytine and Melphalan) is~     the more frequently used high-dose conditioning regimen. Nevertheless, Carmustine is no~     longer available in Europe.~      The investigators have therefore chosen to replace Carmustine by Thiotepa and use the TEAM~     regimen as the new conditioning. Indeed, Thiotepa is approved by french national agency for~     the security of drugs (ANSM) for use as part of auto-HSCT conditioning regimen. The results~     of TEAM regimen in terms of efficacy and toxicity appear similar to those of BEAM. However,~     no study have been performed prospectively. Only small series and case reports have been~     reported.~      If the study confirms the results of retrospective studies, conditioning by TEAM could become~     a new standard in auto-HSCT for the treatment of lymphoma.~      This study is non-interventional, prospective with 3 centers.~      All included patients will receive, according to standard practice and drug label in France,~     the following diagram:~        1. Conditioning:~             -  Thiotepa 8 mg / kg to J-6~             -  Etoposide 100 mg / m² / 12 h for 4 days (J-5 to D-2)~             -  Aracytine 200 mg / m² / 12 h for 4 days (J-5 to D-2)~             -  Melphalan 140 mg / m² on day-1~        2. Transfusion graft: the day D0 with autologous peripheral stem cell transplant~        3. Care supports: Patients will be treated according to the usual procedures of centers~          participating in the study at the discretion of the investigator.~        4. Follow-up of patients will not be changed by the study.~      The main objective of the study is to evaluate the progression-free survival (PFS) of~     lymphoma patients treated with autologous stem cells after conditioning by TEAM~      Secondary objectives are:~        -  To evaluate overall survival;~        -  To assess the response to treatment;~        -  to evaluate the incidence of relapse;~        -  to assess the toxic transplant related mortality;~        -  to study transplant-related morbidity (infections, nutritional and gastrointestinal~          toxicity, immune reconstitution).~   "
81191|NCT02504177|"~     This study is to evaluated the interruption schedule of NOAC in patients who undergo atrial~     fibrillation ablation. The investigators will compare the bleeding complications were~     classified as major and minor bleeding, thromboembolic, vascular complications, Re-admission~     and increased in the length of hospital stay during the 30-day post-radiofrequency catheter~     ablation(RFCA) period among patients who interrupt NOAc 24hours before ablation and patients~     who stop NOAC in the morning of the procedure.~   "
81192|NCT02504164|"~     Endoscopic submucosal dissection is commonly performed under light to moderate sedation, and~     minimizing patient movement is of key importance for successful outcome. Propofol has widely~     replaced benzodiazepines as sedative drug of choice, and has been reported to enhance the~     quality of procedure in our past study. However, despite higher satisfaction scores of the~     endoscopists and faster post-procedural recovery, patient satisfaction scores were found to~     be higher in patients that received midazolam and meperidine instead of propofol and~     remifentanil. This seems to be due to the anterograde amnestic effects of midazolam rather~     than the quality of sedation itself. Investigator hypothesized that by premedicating the~     patient with low lose midazolam before receiving sedation for ESD with propofol and fentanyl,~     patient satisfaction would be enhanced without affecting endoscopic performance.~   "
81193|NCT02504151|"~     Cannabidiol (CBD) is a component of herbal cannabis that is present in varying concentrations~     in cannabis extracts. CBD has been shown to produce central effects including hypnotic,~     anticonvulsive, anxiolytic and neuroprotective effects.The investigators hypothesize that~     treatment with CBD will result in: 1) Improvement evidenced by a reduction in scores on the~     Positive and Negative Syndrome Scale for Schizophrenia (PANSS), 2) Improvement evidenced by a~     reduction in the Clinical Global Impression of Severity scale (CGI); Secondary Hypothesis: 1)~     Greater improvement in functioning as measured on the Patient Assessment of Own Functioning~     Inventory: (PAOFI) and the Quality of Life Scale (QLS) In this 2 period cross over design,~     subjects will be randomized in a 1:1 ratio to receive either: Order 1: CBD (Period 1)~     followed by placebo (Period 2) or Order 2: Placebo (Period 1) followed by CBD (Period 2)~     under double-blind conditions. The 2 study periods will be separated by a washout of at least~     2 weeks. During each period subjects will receive study medications (CBD [total 800mg/day] or~     placebo) for a period of 4 weeks.~   "
81195|NCT02504125|"~     A randomized, double-blind, single-center and controlled study comparing the efficacy and~     safety of intravenous administration of tranexamic acid to reduce blood loss in simultaneous~     bilateral total knee arthroplasty.~   "
81198|NCT02504086|"~     The purpose of this study is to evaluate the effect of online support for diabetes~     self-management for patients with Type II diabetes in the Vancouver region. Patients will be~     invited to receive 8 online video consultations (total 2.5 hours) with certified healthcare~     providers (video calls in a secure Website). Participants will also have access to the use of~     an online personal health record -- a place to store healthcare information for the patient~     and healthcare provider to view. Patients' ability to care for their diabetes will be~     measured at the beginning and the end of the study. Additional measures include glycaemic~     control, BMI, waist circumference, diabetes self-efficacy, computer and health literacy,~     patient satisfaction with care and perceived ease of use and perceived usefulness of the~     technology.~   "
81199|NCT02504073|"~     The goal of this study is to find out what clinical reasoning process physiotherapists~     undergo when observing hemiplegic patients gait.~   "
81200|NCT02504060|"~     This study is a randomized double-blind placebo-controlled clinical trail to evaluate the~     clinical efficacy and safety of 1.1 chemical drugs N-acetyl-D-glucosamine on Chinese IBS-D~     patients coming from thirty- six centers in Chinese. 720 IBS-D patients (360 for treatment~     group, 360 for placebo group) in this research are accord with the Rome III diagnostic~     criteria, screening/import period pain intensity scores of the NRS(numerical rating scale)~     week mean value are 3.0 plus and the days which at least more than one time a stool type are~     6 or 7 type over 2 days/week. Test cycle includes screening/import period (2 weeks), open~     treatment period (12 weeks), follow-up period (2 weeks). The main outcome measures are pain~     intensity (NRS score 11 point scale) and stool type ( Bristol type), and secondary endpoints~     included overall symptoms sensory scores, defecation frequency, abdominal distension,~     defecation urgency and quality of life parameters (IBS-QOL scale).~   "
81201|NCT02504047|"~     The administration of high-dose chemotherapy followed by the infusion of blood or bone marrow~     stem cells (stem cell transplantation) from a matched donor has become standard treatment for~     patients with high-risk or relapsed hematological cancers. Currently, donors are found for~     approximately 80% of people who require such treatment, although the chance of finding a~     donor is much lower in some ethnic communities. In the current study the investigators will~     offer patients requiring transplantation, but for whom well matched donors cannot be~     identified either from within the family or on the donor registry, a transplant from a~     half-matched (haploidentical) family member. A myeloablative conditioning regimen and~     un-manipulated peripheral blood stem cells will be used. Post-transplant cyclophosphamide,~     tacrolimus and mycophenolate mofetil will be used to prevent graft versus host disease~     (GVHD). The primary outcome measure will be 6 month survival free from graft failure, relapse~     and grade 3-4 acute GVHD. Other outcomes of interest will include the frequency of~     Cytomegalovirus (CMV) or Epstein-Barr Virus (EBV) requiring treatment, overall survival and~     progression-free survival.~   "
81202|NCT02504034|"~     To evaluate the values of portosystemic shunt and other interventional radiology approaches~     for treatment of symptomatic portal hypertension in patients with cavernous transformation of~     portal vein.~   "
81203|NCT02504021|"~     A randomized clinical trial for patients with end stage renal disease in which a family~     consultation condition is compared against a treatment as usual control condition on the~     hospital readmissions after 1 month as the primary outcome variable.~   "
81204|NCT02504008|"~     This is a randomized, double-blind, placebo-controlled, 24-week study to evaluate the~     efficacy and safety of AXS-02 in patients with CRPS-I.~   "
81205|NCT02503995|"~     This study aimed to investigate whether there are measurable differences in CHANS function in~     pregnant women who receive only standard antenatal care compared with those who additionally~     undertake a programme of regular physical exercise.~   "
81206|NCT02503982|"~     Valganciclovir is extensively used for cytomegalovirus (CMV) infection treatment and~     prophylaxis after solid organ transplantation (SOT). VGC dosing is problematic in children.~     valganciclovir has variable absorption and is renally excreted. Area Under the Curve (AUC)~     (0-24) of 40-60 mcg∙h/L is a predictive pharmacokinetic parameter of efficacy and safety.~     Dosing based on manufacturer recommendations is supra-therapeutic in most cases. A few~     published dosing algorithms result in AUC out of range.~      Objective: To prospectively validate a Valganciclovir administration dosing regimen and~     compare it to other dosing algorithms.~      Methods: Children after SOT at Schneider Children's Medical Center, the largest tertiary~     pediatric center in Israel, were prospectively studied, starting Dec 2014. The dosing regimen~     was derived from Seattle Children's Hospital guidelines; 14-16 mg/kg/dose. For impaired renal~     function, stratified dose reduction was used. Blood was withdrawn at steady state: 2, 5 and~     10 hours post dosing. Drug level was analyzed by high pressure liquid chromatography (HPLC).~   "
81207|NCT02503969|"~     The primary aim of this project is to examine the association between having a long-term~     condition (morbidity) and screening uptake for colorectal cancer. Whilst this project will~     consider all morbidity and co-morbidities, there will be a particular focus on common mental~     health disorders, such as depression and anxiety.~      The secondary aim of this project is to examine other factors that may influence uptake rate.~     Information on a wide array of potential factors is available for this project. These include~     demographics (age, gender, ethnicity), socio-economic status (deprivation, education status)~     and lifestyle (smoking status, drinking patterns, degree of exercise). In addition, any~     potential moderating effect of these factors on the association between morbidity and~     screening uptake shall be explored.~      In summary, the following shall be explored:~        -  Uptake rates by type of mental health disorder.~        -  Uptake rates by chronic physical health problems.~        -  Associations between uptake, morbidity (both physical and mental) and broader health~          determinants such as demographics, socio-economic status and lifestyle.~   "
81208|NCT02503956|"~     Assessing efficacy of punctal dilatation with insertion of perforated punctal plugs for the~     management of acquired punctal stenosis due to allergic conjunctivitis in otherwise healthy~     patients.~   "
81327|NCT02502409|"~     This study will examine two groups of subjects with factor IX (FIX) deficiency: 1) those with~     a current or history of inhibitors to FIX, and; 2) groups of two or more affected brothers,~     with or without inhibitors. The overall goal is to characterize the study groups in terms of~     their medical history, their patterns of bleeding, their care, quality of life, and~     complications including the development of joint disease, inhibitory antibodies to FIX, use~     of immune tolerance induction (ITI) and outcome.~   "
81209|NCT02503943|"~     Obesity is one of the characteristics of type 2 diabetes mellitus. Most of the obese diabetes~     patients are combined with dyslipidemia or hypertension. The clustering of diabetes, obesity,~     hypertension and dyslipidemia increases the risk of cardiovascular events for patients. GLP-1~     (glucagon like peptide-1) is a kind of incretin discovered in recent years. It was reported~     that beside its hypoglycemic and losing weight effects, activator of GLP-1 receptor could~     decrease blood pressure and improve lipid metabolism. Therefore, activation of GLP-1 receptor~     may become a new comprehensive treatment strategies for improving glucose and lipid~     metabolism, blood pressure level and cardiovascular complication. But, it is lack of~     evidence-based medicine proof on the relationship between GLP-1 and blood pressure or serum~     lipid. So, investigators designed a prospective, randomized, open-label, active control~     study, and try to evaluate the effects of activator of GLP-1 receptor (liraglutide) on~     lowering blood pressure, improving vascular function and lipid metabolism in overweight or~     obese type 2 diabetic patients with masked hypertension.~   "
81210|NCT02503930|"~     The concurrent performance of two tasks, i.e., dual tasking (DT), is a common and ubiquitous~     every day phenomena. For example, people frequently walk while talking on a cellphone or~     drive while talking to a passenger. Often, the performance of one or more of these~     simultaneously performed tasks may deteriorate when another task is carried out at the same~     time, even in healthy young adults. This reduction in performance is referred to as the DT~     deficit or DT cost and is typically much higher in patients with Parkinson's disease (PD)~     than in young adults or age-matched controls. In PD, this DT cost impairs the gait pattern,~     as manifested, for example, in increased gait variability, exacerbating instability and fall~     risk.~      In the proposed study, would be evaluated the effects of tDCS on dual tasking performance~     following tDCS.~      The researchers expect that stimulation of the Pre Frontal Cortex (PFC) (using tDCS) will~     increase DT performance and prefrontal activation.~   "
81211|NCT02503917|"~     This study will establish the feasibility and accuracy of localising and outlining the uterus~     on ultrasound images using both healthy volunteer and cervical patient cohorts. This will~     enable us to determine whether or not ultrasound will be a good option to ensure the correct~     patient position prior to radiotherapy for cervical cancer patients.~   "
81212|NCT02503904|"~     The principal aim of the present research is to compare two methods of antibiotic delivery:~     concomitant tumescent antibiotic delivery (TAD) and intravenous antibiotic delivery (IVAD)~     versus IVAD alone, (TAD+IVAD vs IVAD), with respect to the prevention of surgical site~     infections (SSI). The investigators hypothesize that TAD+IVAD will significantly reduce the~     incidence of SSI compared to IVAD.~      TAD is the subcutaneous infiltration of a dilute solution of antibiotic(s) in a solution of~     tumescent local anesthesia (TLA). TLA consists of a dilute solution of lidocaine (1gm/L),~     epinephrine (1mg/L) and sodium bicarbonate (10mEq/L) in 0.9% physiologic saline.~      A secondary aim of this study is to compare TAD+IVAD vs IVAD with respect to the prevention~     of post-operative venous thromboembolism (VTE).~   "
81213|NCT02503891|"~     M.M.A.TECH Ltd. product is an Acetabular Liner Family produced of an advanced polyimide -~     MP-1™.~      M.M.A.TECH Ltd. produces the Liners according to EN ISO 13485:2012 approved manufacturing~     process and supplies them to the customer.~      The aim of this study is to evaluate, in the frame of PMCF, the safety and performance of~     using AL-X MP1 Polyimide Acetabular liners in Total Hip Replacement surgery by clinical~     following up of patients for a period of 2 years .~   "
81214|NCT02503878|"~     Masimo Sedline brain function monitors are sensors (stickers) placed on a the forehead to~     monitor levels of sedation based on a bilateral 4-channel electroencephalogram (EEG). The~     purpose of this study is to observe the effectiveness of the Sedline monitor to detect the~     unilateral hemispheric EEG changes seen in Wada testing~   "
81215|NCT02503865|"~     Metabolic syndrome: aetiology, pathogenesis, diagnosis, clinical management and prognosis~   "
81216|NCT02503852|"~     The primary objective of this study is to evaluate the safety and feasibility of the Celution~     and Puregraft Systems in the processing and preparation of an autologous fat graft enriched~     with adipose-derived regenerative cells (ADRCs) in the treatment of early alopecia~     androgenetica.~   "
81217|NCT02503839|"~     Tuberculosis (TB) is a global challenge and for the increasing epidemic of multi-drug~     resistant (MDR)-TB there is restricted treatment options. This calls for research of new~     immune-modulating treatment strategies that can strengthen the patients immune system to~     better fight the TB bacteria. The pro-inflammatory, but still immunosuppressive mediator~     prostaglandin E2 (PGE2) is produced by cyclooxygenase-2 (COX-2) in inflamed infected tissue.~     Studies from both human and animal models show that COX-2 inhibitors (COX-2i) can improve the~     immune system and strengthen vaccines responses.~      Hypothesis~        1. A hyperactive COX-2/PGE2 signal system in active TB causes down-regulated immune~          responses that favour TB survival, but this can be abrogated by COX-2i.~        2. TB-specific immunisation with targeted antigens presented as a therapeutic TB vaccine~          and enhanced by COX-2i will improve immune-mediated host clearance of TB.~        3. Combinations of COX-2i and a therapeutic TB vaccine to conventional anti-TB chemotherapy~          offer new treatment modalities for TB, including MDR/XDR-TB.~      Approach to test the hypothesis~        1. Study design: 4-arm, open and randomized clinical intervention trial of patients~          starting treatment for active TB in specialized Norwegian TB centres and where two arms~          will receive the COX-2i etoricoxib with and without a TB vaccine, one arm vaccine only~          and the last arm serve as control receiving only standard anti-TB therapy. For safety~          precautions, only patients bearing sensitive TB strains are included and study arms will~          be sequentially introduced.~        2. In a mouse model examine in more detail the effects of reversion of chronic inflammation~          with COX-2i locally in tissue and the interplay with TB vaccine responses, immune~          regulation, correlates of protection and survival in a well-characterized model for~          TB-exposed mice.~   "
81218|NCT02503826|"~     Effective postoperative pain control is essential for patients and inadequate postoperative~     pain relief can cause mental and psychological sufferings. Despite the growing concern on~     postoperative pain management, acute postoperative pain is still poorly managed. Though~     numerous clinical practice guidelines for postoperative pain management have been published~     throughout the last decades, inadequate pain relief remain a big health care issue.~     Sufentanil has been used as satisfied pain control drug because of its strong potency of~     analgesia for a long while. But its use in patient controlled intravenous analgesia (PCIA)~     has not been clarified. And the dilemma of safety concern and insufficient dosage of~     analgesic is a common problem. Thus the investigators design this prospective randomized~     controlled double blinded trial to observe the efficacy and the optimal dose of sufentanil in~     PCIA in patients underwent moderate surgery for the purpose of providing reference in~     clinical practice.~   "
83877|NCT02469103|"~     The purpose of this study is to investigate the accuracy of second generation colon capsule~     (C2) in evaluating colonic mucosal inflammation of ulcerative colitis patients, using~     conventional endoscopy as the gold standard.~   "
81219|NCT02503813|"~     One required examination for declaration of death by neurological criteria is the apnea~     challenge test. The apnea challenge test evaluates the medulla brainstem respiratory center~     response to a rise in CO2. The current guideline requires arterial sampling of CO2 and~     therefore either arterial puncture or arterial catheter placement for the examination.~     Arterial catheter is an invasive monitoring device and is not without complications. Recent~     studies have demonstrated that there is a direct correlation between peripheral venous and~     arterial blood gas measures and that peripheral venous CO2 measures may be used as~     alternatives to arterial CO2 measure.The purpose of this study is to evaluate brainstem~     response during the apnea challenge test to a rise in venous CO2 and correlate it with the~     rise in arterial measured CO2. The objective of this study is to demonstrate a similar rise~     between the venous and arterial CO2 during the apnea challenge test and eliminate the~     necessity of arterial blood sampling for the sole purpose of apnea challenge test in the~     future.~   "
81220|NCT02503800|"~     The investigators wish to evaluate the association between tryptase values as well as c-Kit~     mutation and adverse effects in the course of immunotherapy. The investigators also intend to~     assess the effect of immunotherapy on tryptase levels.~   "
81221|NCT02503787|"~     The purpose of this study is to evaluate programming options in spinal cord stimulation for~     the management of chronic, intractable pain of the trunk and limbs.~   "
81222|NCT02503774|"~     The purpose of this study is to Evaluate the Safety, Tolerability, Pharmacokinetics,~     Immunogenicity, and Antitumor Activity of MEDI9447 Alone and in Combination with MEDI4736 in~     Adult Subjects with Select Advanced Solid Tumors~   "
81223|NCT02503761|"~     Newborns in the neonatal intensive care unit (NICU), especially premature ones with immature~     organ systems, frequently suffer nosocomial infections caused by microorganisms resistant to~     narrow-spectrum antibiotics like ampicillin and gentamicin and require introduction of new~     agents with a wider spectrum of activity.~      Meropenem has activity against wide variety of Gram-negative and Gram-positive bacteria. It~     is well tolerated by children and neonates, including preterm babies, and allowing~     monotherapy instead of combined therapy.~      Severe neonatal infections with increasing antibiotic resistance are major problems affecting~     morbidity and mortality in the NICU. Few number of new antibacterial agents entering the~     clinic and new agents for multi-drug resistant Gram-negative bacteria will unlikely be~     available in the near future.~   "
81224|NCT02503748|"~     In a participatory process involving urologists and former patients, the project team has~     developed an online information system (tutorial) for patients with localized prostate~     cancer. In this field test, relevant outcomes are measured and the tutorial will be tested~     for its clinical applicability.~   "
81225|NCT02503735|"~     Treatment protocol to see if people with hepatitis C (HCV) and chronic kidney disease (CKD)~     who are treated with Harvoni for 12 weeks have improvements in their kidney disease.~   "
81226|NCT02503722|"~     This phase I trial studies the side effects and best dose of sapanisertib when given together~     with osimertinib in treating patients with stage IV EGFR mutation positive non-small cell~     lung cancer that has progressed after treatment with an EGFR tyrosine kinase inhibitor.~     Sapanisertib and osimertinib may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth.~   "
81227|NCT02503709|"~     This phase I trial studies the side effects and best dose of onalespib and CDKI AT7519 in~     treating patients with solid tumors that have spread from the primary site (place where they~     started) to other places in the body (metastatic) or cannot be removed by surgery. Onalespib~     and CDKI AT7519 may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth.~   "
81228|NCT02503696|"~     The primary objective of this study is to gather stool samples from subjects with~     inflammatory bowel disease (IBD) to be added to a test set of stool samples that will be~     utilized to help select molecular markers and determine the optimal sensitivity and~     specificity values for the Exact IBD-ACRN surveillance test for colorectal cancer (CRC).~   "
81229|NCT02503683|"~     The purpose of this study is to evaluate the Safety, Tolerability, Pharmacokinetics and~     Pharmacodynamics of Subcutaneously Administered ALN-AAT in Healthy Adult Subjects and~     Patients with ZZ Type Alpha-1 Antitrypsin Deficiency Liver Disease.~   "
81230|NCT02503670|"~     The purpose of this study is to develop and pilot test HealthyDads.ca, a website for~     expectant first-time fathers who have known risk factors for depression.~   "
81231|NCT02503657|"~     This is a randomized, placebo-controlled, double-blind, 6-month study followed by a 6 month~     open-label extension phase to evaluate the efficacy, safety, and tolerability of MN-001 in~     moderate to severe IPF patients. MN-001 750 mg or matching placebo will be orally~     administered twice daily over a 26 week period in subjects with a confirmed diagnosis of IPF~     per the ATS )American Thoracic Society) 2011 Guidelines. Approximately 15 subjects are~     planned to be enrolled. This study will consist of two treatment arms, MN-001 and matching~     placebo. Randomization will occur in a 2:1 ratio (MN-001: placebo). Eligible subjects will~     consist of males and females ranging in age from 21 to 80 years old, inclusive.~      The study will consist of a Screening Phase (up to 3 months prior to Day1) followed by a 26~     week double-blind Treatment Phase, a 26 week Open-Label Extension (OLE) phase and a Follow-up~     Visit (within 4 weeks after the last dose).~   "
81232|NCT02503644|"~     Systemic sclerosis (SSc), or scleroderma is a connective tissue disease of autoimmune origin.~     It is a life-threatening orphan disease with severe physical and psychosocial consequences.~     IVA337 has a novel mechanism of action and this study is designed to compare IVA337 at two~     dose levels with a placebo control treatment. Patients will be unaware of the treatment they~     are receiving and will be randomized to one of three treatment arms , either IVA337 400mg~     bid, IVA337 600mg bid or placebo bid. They will receive drug for 48 weeks and during that~     time assessments will be made to monitor both the efficacy and safety of the treatment.~   "
81233|NCT02503631|"~     The primary objective of this study is to obtain de-identified, clinically characterized,~     stool and plasma specimens for use in assessing new markers for the detection of neoplasms of~     the digestive tract.~   "
81234|NCT02503618|"~     The scientific purpose of this study is to look at how substance use may relate to human~     immunodeficiency virus (HIV) infection among young black men who have sex with men in~     Atlanta.~   "
81236|NCT02503592|"~     This study will measure the effects of soft surgical techniques on vestibular function and~     quality of life in patients pre- and post-cochlear implant (CI) surgery. Additionally, the~     investigators will attempt to systematically evaluate the utility of different~     electrophysiological measures of vestibular system function in surgical ears.~      Vestibular system function in CI patients will be evaluated pre-surgically and twice~     post-surgically, at 3 months and again at 1 year post-surgery. Traditional test techniques -~     such as VNG, rotational testing, and air conduction VEMPs - will be compared to and~     cross-checked with newer techniques including video head impulse testing (vHIT) and bone~     conduction VEMPs.~   "
81237|NCT02503579|"~     This doctoral thesis has the aim to identify the role of Brain-derived neurotropic factor in~     the relationship between physical fitness/activity and executive functions in typically~     developing children and children with Autism Spectrum Disorder, Development Coordination~     Disorder , Attention Hyperactive Disorder.~   "
81238|NCT02503566|"~     Cardiac allograft vasculopathy (CAV) is characterized by marked intimal proliferation and~     concentric vascular thickening and fibrosis. CAV remains the leading cause of late morbidity~     and mortality in heart transplant recipients. Optical coherence tomography (OCT) is a new~     generation catheter-based modality that acquires images at a spatial resolution of 10-20 μm~     which is 10-fold greater than that of intravascular ultrasound (IVUS). OCT is currently the~     most sensitive imaging technique for early CAV detection. Recent studies proved that~     circulating human leukocyte antigen (HLA) directed donor-specific antibodies correlate with~     increased mortality and CAV. Contradiction of scientific results has been reported regarding~     increased resting heart rate and development of CAV. Larger prospective studies using more~     sensitive CAV detecting methods are required to enhance our understanding. Novel~     immunosuppressants, mechanistic target of rapamycin (mTOR) inhibitors, may attenuate CAV~     progression and may improve long-term allograft survival owing to favorable coronary~     remodeling.~      Aim of the study: Use OCT imaging for identification of patients with early rapid progression~     of CAV (rapid progressors) and to identify the critical risk factors responsible for CAV~     progression. The impact of conventional and heart transplant (HTx) specific risk factors,~     such as donor-specific antibodies or rapid heart rate will be studied in a prospective,~     national-level cohort study. The implication of OCT results will lead to adjustment of~     immunosuppressive therapy in one year after heart transplant to prevent further progression~     of the disease in CAV rapid progressors.~      Working hypotheses:~        1. Patients with rapid progression of cardiac allograft vasculopathy can be identified by~          increased titers of donor specific anti-human leukocyte antigen (anti-HLA) and/or~          antibodies against major histocompatibility complex (MHC) class I-related chain A (MICA)~          antibodies.~        2. Specific high-risk characteristics of anti-HLA antibodies can be identified that are~          associated with particularly high rate of CAV progression (vascular complement~          activation in biopsies, certain HLA haplotypes).~        3. Tachycardia in heart transplant recipients represents a risk factor for development of~          cardiac allograft vasculopathy.~        4. Influence of anti-HLA antibodies and increased heart rate is independent of already~          established risk factors of CAV.~   "
81239|NCT02503553|"~     Identifying and making a decision about the best health treatment or screening option can be~     difficult for patients. Decision aids can be used when there is more than one reasonable~     option, when no option has a clear advantage in terms of health outcomes, and when each~     option has benefits and harms that patients may value differently.~      Decision aids may be pamphlets, videos, or web-based tools. They make the decision explicit,~     describe the options available, and help people to understand these options as well as their~     possible benefits and harms. This helps patients to consider the options from a personal view~     (e.g., how important the possible benefits and harms are to them) and helps them to~     participate with their health practitioner in making a decision.~      Cerebral aneurysms are common and potentially very dangerous. However, there are important~     treatment choices that may prevent bleeding and stroke before aneurysm rupture.Current~     procedural options are clipping and endovascular coiling. The anatomy of most aneurysms is~     amenable to either treatment.~      The treatment decisions are not simple, since each choice has its own trade-offs. How the~     benefits and trade-offs are valued varies across different patients, and, therefore, the~     right treatment decision needs to include greater patient participation. This starts with~     better communication of the probabilities associated with the outcomes of each option in~     terms that can be understood by patients. Equally important is helping the patients clarify~     their own treatment goals, as well as legitimizing patients' partnership in the~     decision-making process. Tools (e.g., decision aids) to achieve shared decision-making, are~     lacking in this area of medicine. We propose to investigate the impact of such decision aids~     on patient satisfaction and the outcomes of cerebral aneurysm coiling and clipping.~      Aim 1. To determine whether structured decision aids offered to cerebral aneurysm patients~     are associated with increased patient participation in the decision making process as~     indicated by the OPTION score~      Aim 2. To determine whether structured decision aids offered to cerebral aneurysm patients~     are associated with improved quality of life and patient satisfaction outcomes immediately~     preoperatively, and 30 days postoperatively.~   "
81240|NCT02503540|"~     This interventional study will evaluate the retinal vascular dynamics associated with~     Intravitreal Aflibercept Injection (IAI) therapy in eyes with diabetic macular edema (DME) or~     macular edema secondary to retinal vein occlusion (RVO). Ultra-widefield fluorescein~     angiography and OCT angiography will be performed at multiple timepoints to assess the~     changes in retinal vascular leakage, ischemia, and vascular abnormalities throughout the~     study duration and compare these alterations to baseline.~   "
81241|NCT02503527|"~     The purpose of this study is to determine the efficacy and safety of a diabetes-specific tube~     feed in comparison to an isocaloric, isonitrogenous standard enteral formula in critically~     ill patients receiving insulin treatment for blood glucose management.~   "
81242|NCT02503514|"~     Purpose: Inflammatory bowel disease patients undergoing treatment with varying biologic~     agents will be evaluated for incidences of paradoxical immune reactions, the risk factors~     associated with those paradoxical immune reactions, and whether the paradoxical immune~     reactions and their associated risk factors differ based on formulation of biologic agent.~      Participants: All adults (≥18 year) with confirmed IBD on a biologic agent or with plans to~     initiate treatment in 1 month~      Procedures (methods): Subjects undergoing treatment with a biologic agent will be followed~     indefinitely for paradoxical immune reactions. Data will be collected at baseline as well as~     serum and plasma for banking. Subjects will be followed at 6 month intervals either via~     email, telephone interviews or at the time of clinic follow-up visits. In the event of a~     de-novo paradoxical reaction, specific information will be collected from sites in an event~     capture form, with data abstracted from routine clinical care for the paradoxical reaction.~     Subjects will continue to be followed every 3 months after the event via email, telephone~     contact to determine whether resolution and/or recurrence occurred, and to determine any~     changes in medical therapy. Serum and plasma will be re-collected at the time of first event~     for comparison to baseline samples and to samples from controls (those on biologics without~     study documented paradoxical immune reactions). At resolution of the event, patient will~     return to 6 month follow up schedule. Subjects can discontinue and/or fail a particular~     biologic treatment; therefore they will also be followed for paradoxical immune reactions, on~     any new biologic treatment they undergo while in the study.~   "
81243|NCT02503501|"~     This study evaluates the safety and effectiveness of intranasal (IN) glulisine in patients~     with amnestic mild cognitive impairment (aMCI) and probable Alzheimer's disease. Half of~     participants will receive IN glulisine, while the other half will receive IN placebo.~   "
81328|NCT02502396|"~     The primary objective of this study is to evaluate the practice patterns of rivaroxaban usage~     invenous-thromboembolism (VTE) and non-valvular atrial fibrillation (NVAF) in cancer~     patients.~      The secondary objectives are to evaluate outcomes such as recurrent VTE, stroke and bleeding~     for cancer patients on rivaroxaban.~   "
81244|NCT02503488|"~     The purpose of the current study is to examine the psychological well-being of youth within~     the context of participation in political violence during the 2015 election period in~     Burundi. In detail, the investigators are interested in fostering improved outcomes in a~     peace-building initiative aimed at youth in Burundi by reducing the mental health-related~     stress of the initiative's most severely affected participants. In addition, the~     investigators are interested in learning more about the youth experience of involvement in~     the Burundian political system in an effort to understand the links between youth engagement~     in political violence and past experiences of traumatic events.~   "
81245|NCT02503475|"~     The purpose of the Stanford Center for Back Pain is to investigate and characterize the~     mechanisms of four treatments for chronic low back pain. These interventions (research~     treatment) include real-time fMRI neurofeedback, mindfulness based stress reduction,~     cognitive behavioral therapy, and acupuncture treatment. The investigators plan to~     characterize both mechanisms of treatment effects and efficacy.~   "
81246|NCT02503462|"~     The purpose of this study is to assess whether a boosting by cobicistat results in similar~     concentrations of darunavir in the brain compared to a boosting by ritonavir.~   "
81247|NCT02503449|"~     The purpose of the study:1.Improve the understanding of the risk factors of pulmonary~     cryptococcosis;2.Improve the awareness of pulmonary cryptococcosis clinical and imaging~     manifestations;3.Grasp pulmonary cryptococcosis patients of clinical and imaging~     manifestations in different conditions;4.Learn about antibacterial activity of antifungal~     drugs for cryptococcosis in China.~   "
81248|NCT02503436|"~     The main objective of the proposed non-interventional study is to obtain real-world~     effectiveness, safety and treatment patterns data of patients with BRCAm+ (Breast Cancer~     Gene(s) mutation positive) platinum sensitive relapsed (PSR) ovarian cancer in German~     hospitals and outpatient practices treated with olaparib.~   "
81249|NCT02503423|"~     This is an open-label, dose-escalation Phase 1/2 study to assess the safety of ASTX660,~     determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and recommended~     dosing regimen, and to obtain preliminary efficacy, pharmacokinetic (PK), and target~     engagement data, in subjects with advanced solid tumors or lymphoma for whom standard~     life-prolonging measures are not available.~   "
81250|NCT02503410|"~     This study aims to compare the outcomes of a traditional, exercise-based rehabilitation~     intervention for chronic low back pain with the outcomes achieved by combining a traditional~     intervention with adjunct therapy delivered using an interactive gaming-based system for~     home-based therapy. 50 subjects with non-specific cLBP will be recruited in the study.~     Following baseline measures, study volunteers will be randomized to either the Usual Care~     alone group or to the Interactive Home-Based System group. In each group, an endpoint~     assessment session will be conducted at approximately 4 and 8 weeks post baseline measures.~   "
81251|NCT02503397|"~     This study evaluates auditory neural maturation by auditory brainstem evoked response in late~     preterm and term infants with in utero iron deficiency compared with neonates with normal in~     utero iron status.~   "
81252|NCT02503384|"~     Background: In mainland China, the development of pediatric liver transplantation (LT) has~     lagged behind that of adult LT during the past two decades, but it has been progressing~     immensely in recent years. Renji hospital(shanghai) is currently the largest pediatric~     transplant center in mainland China.~      Aim and method: This study is performed for establishment of key techniques for pediatric LT~     in mainland China, including the indications and timing for pediatric LT, the criteria for~     donor selections, living donor LT planning, prevention and treatment for posttransplant~     complications, long-term follow-up management et al.~   "
81253|NCT02503371|"~     Since its introduction in 1978, over 3.75 million babies have been born using in vitro~     fertilization (IVF). Maturing ovarian follicles lead to a large rise in estrogen to~     supra-physiological levels . This increase in estrogen has been shown to cause a~     hypercoagulable state, leading at times to arterial and venous thrombosis.(Thromboelastogram~     (TEG) is a point of care whole blood hemostatsis analyzer mimicking in vivo conditions and~     measuring visco elastic properties of the clot. The TEG shows effect of most of the~     components of hemostatsis: coagulation factors, fibrinogen, platelets and fibrinolysis.~     Components of TEG include R, reflecting coagulation factor cascade, alpha angle and K~     measurements reflecting fibrin function, MA reflecting mostly thrombocyte function,~     coagulation index (CI) measuring global hemostatic statis and LY30 measuring fibrinolysis.~      In this study the investigators would like to measure serum estrogen levels and (TEG) in~     parturients at the beginning and conclusion of an IVF simulation cycle and evaluate how it's~     influnence on coagulation parameters, and wheather or not a large sample size will effect~     primary outcomes.~      Secondarily the investigators would like to see if estrogen levels are predictors of~     coagulation parameters and see if age influences TEG parameters~   "
81254|NCT02503358|"~     This randomized phase I trial is studying the side effects and the best dose of selumetinib~     when given together with paclitaxel as a second line therapy in treating patients with stage~     IIIB-IV non-small cell lung cancer (NSCLC). Selumetinib may stop or slow the growth of tumor~     cells by blocking a protein called mitogen-activated protein kinase (MEK) that is needed for~     cell growth. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop~     the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Giving selumetinib together with paclitaxel may kill more tumor~     cells.~   "
81255|NCT02503345|"~     The purpose of this study is to evaluate the safety, tolerability, and efficacy of different~     doses of ALLN 177 for reducing urinary oxalate excretion in patients with secondary~     hyperoxaluria and recurrent kidney stones.~   "
81256|NCT02503332|"~     The primary objectives of the study are to assess the safety, tolerability and evidence of~     activity of multiple intravitreal (IVT) injections of APL-2 in subjects with Geographic~     Atrophy associated with Age-Related Macular Degeneration (AMD).~   "
81257|NCT02503319|"~     The purpose of this study was to evaluate that the tranexamic acid (TXA)Intravenous and oral,~     is equivalent oxytocin (OXY),intramuscularly, in reducing the blood loss in post partum~     period (mL) in patients at the end of pregnancy ( 37-42 w ) at low risk of post partum~     hemorrhage (PPH). The PPH means a blood loss equal to or greater than 500 ml after a vaginal~     delivery ( the bleeding is defined severe if it exceeds 1000 mL). PPH is called primary~     when blood loss arose within 24 hours after birth.~      This is a open-trial randomized, longitudinal, controlled that including 486 subjects .~   "
81258|NCT02503306|"~     Primary Objective:~      o To assess the change in percent of sexual attempts in which subjects are able to maintain~     an erection of sufficient duration to have successful intercourse between the run-in period~     and treatment period:~        -  The change in percent of sexual attempts in which subjects are able to insert the penis~          into the partner's vagina.~        -  The change in score on the erectile function (EF) domain of the International Index of~          Erectile Function (IIEF) questionnaire.~      Secondary Objective:~      o To evaluate the safety and tolerability of avanafil in patients with erectile dysfunction~     (ED).~   "
81259|NCT02503293|"~     A randomised, cross-over study to compare quality of life and satisfaction in primary~     immunodeficient patients treated with subcutaneous injections of Gammanorm® 165 mg/mL~     administered with two different delivery devices: injections using pump or rapid push.~   "
81260|NCT02503280|"~     Before initiating the full randomized study, a Pilot Safety Phase will be performed. In this~     phase the composition of cells administered via the Biosense Webster MyoStar NOGA Injection~     Catheter System will be tested. The randomized portion of the study will be conducted after a~     full review of the safety data from the pilot Phase by the Data safety monitoring board.~      Following the Pilot Phase of five (5) Fifty (50) patients scheduled to undergo cardiac~     catheterization and meeting all inclusion/exclusion criteria will be evaluated at baseline.~      Patients will be randomized in a 2:2:1 ratio to one of three Treatment Strategies.~   "
81261|NCT02503267|"~     The objective of the study is to investigate congenital disorders of glycosylation in~     congenital heart diseases without a clear molecular or genetic basis.~   "
81262|NCT02503254|"~     The overall goal of the study is to demonstrate the reduction of biomarkers of exposure~     (BoExp) to selected harmful and potentially harmful constituents (HPHCs) in adult smokers~     switching for 5 days from conventional cigarette (CC) to Carbon Heated Tobacco Product 1.0~     (CHTP 1.0) as compared to smokers continuing to use CC.~   "
81263|NCT02503241|"~     The goal of this interventional crossover study in morbidly obese intubated and mechanically~     ventilated patients is to describe the respiratory mechanics and the heart-lung interaction~     at titrated positive end-expiratory pressure levels following a recruitment maneuver with~     transthoracic echocardiography and electric impedance tomography imaging.~   "
81264|NCT02503228|"~     Patients who have a large enough defect in their knee cartilage will sometimes undergo~     surgery to transplant donor cartilage tissue into their defect in an attempt to repair the~     knee. The donor cartilage tissue must be fully tested for disease and contamination before it~     can be placed into a patient. This time, along with the time needed to coordinate the surgery~     and transport the tissue to the hospital, can be substantial. Cartilage tissue does not last~     for long outside a body and the fresher the tissue is, the more likely it is that the patient~     receiving the transplant will heal better.~      The MOPS was developed to preserve the cartilage tissue better than the currently standard~     preservation system is able to. Patients that are enrolled into this study will receive~     cartilage tissue that has been stored in the MOPS instead of the currently standard~     preservation system. Their surgical procedure will not change and be performed as per usual.~     The patient will then be followed for a period of two years in which their progress will be~     assessed using surveys and the healing and integration of the transplanted tissue will be~     assessed using diagnostic imaging and blood and urine samples.~   "
81265|NCT02503215|"~     To study the effects of compression stockings on sleep apnea in hemodialysis patients with~     diagnosed obstructive sleep apnea. The rationale of this study consists in the fluid shift~     theory, which consists in the nocturnal rostral fluid shift from legs, which causes upper~     airways edema.~      The aim of this study is to evaluate if compression stockings could improve such nocturnal~     volume redistribution and, therefore, improve obstructive sleep apnea.~   "
81266|NCT02503202|"~     The study will evaluate the safety and immunogenicity of 3 consistency lots and a high-dose~     lot of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in healthy adults. The primary purpose of this~     study is to demonstrate consistency in the immune responses of participants receiving 3~     separate lots of V920 (at release dose) through 28 days postvaccination. A subset of~     participants representative of all treatment groups will continue through 24 months~     postvaccination in the extension study for the evaluation of safety, and durability of immune~     response. Safety of the vaccines and matching placebo will be evaluated through 6 months~     postvaccination for all participants and through 24 months postvaccination for participants~     continuing in the study extension.~   "
81267|NCT02503189|"~     The purpose of this study is to investigate the superiority of KCT-0809 to placebo, and to~     evaluate safety in dry eye patients with Sjögren's syndrome~   "
81268|NCT02503176|"~     The purpose of this study is to evaluate of the long-term safety and efficacy of KCT-0809 in~     dry eye patients with Sjögren's syndrome.~   "
81269|NCT02503163|"~     The purpose of this study is to evaluate of the long-term safety and efficacy of KCT-0809 in~     dry eye patients with Sjögren's syndrome.~   "
81270|NCT02503150|"~     This trial is to compare the efficacy and safety of modified FOLFOX6 [mFOLFOX6, a specific~     chemotherapy regimen of Oxaliplatin ,5-Fluorouracil and Leucovorin] chemotherapy plus Antigen~     Pulsed Dendritic Cells (APDC，a kind of autologous tumor lysates pulsed human dendritic cells~     vaccine) with modified chemotherapy alone in patients with metastatic colorectal cancer.~   "
81271|NCT02503137|"~     This study will assess the safety, tolerability, and efficacy of SM04554 at concentrations of~     0.15% and 0.25%. Improved knowledge of the changes in hair counts and immunohistochemical~     analysis associated with androgenetic alopecia (AGA) before and after treatment with SM04554~     and compared to placebo may lead to a greater understanding of the underlying mechanisms of~     action of SM04554.~   "
81272|NCT02503124|"~     A randomized controlled trial comparing wake therapy (single night) followed by bright light~     therapy to treatment as usual.~   "
81329|NCT02502383|"~     Using a previously created weight management program for adolescents, the intervention will~     be implemented through school-based health centers (SBHC) and will be delivered by SBHC~     providers trained in Motivational Interviewing. Students at intervention school sites will be~     compared to students at control school sites. All students will have baseline, 1 year, and 2~     year follow-up to assess if students in the intervention school sites will have improved risk~     factor profile for metabolic syndrome, improved nutrition and increased physical activity~     when compared with students at control school sites.~   "
81273|NCT02503111|"~     Human papillomavirus (HPV) is the most common sexually transmitted infection worldwide.~     Infection by certain high-risk oncogenic types of HPV (HR-HPV) is the major cause of several~     cancers in men, notably squamous cell carcinoma (SCC) of the anal canal. Rates of anal~     infection with these HR-HPV strains and the resultant high-grade anal dysplasia and anal~     cancer are much higher in men who have sex with men (MSM) than in the general population.~     Co-infection with human immunodeficiency virus (HIV) further amplifies this burden, making~     the rates of anal SCC in HIV-positive MSM higher than the historic rates of cervical cancer~     prior to the adoption of routine cervical cytology screening. Despite these alarming~     statistics, there are no established protocols for optimal screening and treatment of anal~     HPV and cancer precursors, nor has there been any widespread rollout of organized screening~     programs anywhere in Canada. Further, not only does HPV directly cause significant disease in~     these men, but there is growing epidemiologic evidence that HPV infection may enhance sexual~     transmission of HIV. These significant knowledge gaps translate into fundamental deficiencies~     in care for HIV-positive MSM.~      The HPV Screening and Vaccine Evaluation in MSM (HPV-SAVE) study team will recruit a large~     group of MSM to carry out a number of different studies. One key component of recruitment~     entails the mailing of invitations with educational materials in an invitational package to~     subjects in order to determine who would be interested in having anal cancer screening. In~     this way, the investigators will reveal factors that are important in acceptance of~     screening.~      The HPV-SAVE team brings together community and internationally-recognized experts in HPV and~     HIV disease and mucosal immunology, to better define the optimal approaches for primary and~     secondary prevention and treatment of HPV-associated anal disease among HIV-positive MSM, and~     to explore biological mechanistic evidence regarding the potential role of HPV as a co-factor~     for HIV transmission. This will yield critical information which can lead to improvement in~     the health of MSM, and will provide a foundation on which to build further, large-scale~     screening and treatment trials on a national level.~   "
81274|NCT02503098|"~     This study will augment an existing mobile application for individuals with eating disorders~     by developing adaptive, tailored content targeting remediation of cognitive distortions. The~     adaptive application will be deployed and assessed for efficacy relative to the standard~     product in a randomized controlled trial.~   "
81275|NCT02503085|"~     The purpose of this study was to determine the rate and extent of absorption of Ibuprofen~     suspension formulations.~   "
81276|NCT02503072|"~     The goal of this study is to identify ways for implementing small prizes allocated by a~     drawing to improve adherence to antiretroviral medication in an HIV clinic in Kampala,~     Uganda. The study is called Rewarding Adherence Program (RAP).~   "
81277|NCT02503059|"~     Evaluate the 3-year survival of etanercept in patients over 60 years with psoriasis in~     moderate / severe plaque and the reasons that led to the abandonment. Besides factors that~     might have had a positive or negative influence on adherence to treatment and analysis of~     efficacy (PASI 75) and safety will be identified.~      All variables were collected through retrospective review of medical records of patients~     dermatology unit are made.~   "
81278|NCT02503046|"~     Periodontitis and Rhematoid arthritis are chronic inflammatory diseases which share common~     risk factors The purpose of this study is to determine if Pentraxin 3 and Porphyromonas~     Gingivalis levels play an important role in the progression of both the diseases.~   "
81279|NCT02503033|"~     The purpose of this study is to evaluate the safety and tolerability of HMPL-523 administered~     to patients with relapsed or refractory Hematologic Malignancies~      To determine the maximum tolerated dosage/recommended phase 2 dosage and characterize the~     dose limited toxicities associated with HMPL-523 when administered to patients with relapsed~     or refractory Hematologic Malignancies~   "
81280|NCT02503020|"~     Long-chain polyunsaturated fatty acids (LCPUFAs), arachidonic acid (AA omega-6; 20:4ω-6), and~     docosahexaenoic acid (DHA omega-3; 22:6ω-3), are required for the formation of non-myelinated~     cell membranes in the central nervous system, including in the retina, hence the great~     importance of them for appropriate visual and cognitive development.~      In this study, the investigators assessed anthropometric, visual, auditory, and psychomotor~     development in very preterm infants who had diets supplemented with different LCPUFA amount~     of AA to support the importance of sufficient AA values in formula.~   "
81281|NCT02503007|"~     Sustained high-intensity activity, such as survival training with little nourishment~     available, can result in a loss of muscle performance. This study will examine the effects of~     a nutritional supplement to maintain muscle and muscle performance during this period.~   "
81282|NCT02502994|"~     This study is designed to evaluate the safety and efficacy of a single injection of GEN0101~     in patients with recurrence of castration resistant prostate cancer.~      The subjects receive GEN0101 injection 4 times per two weeks (1st intratumoral injection and~     followed subcutaneous injection) and two weeks of observation as one cycle treatment period.~     Each subject receive two cycle treatment period.~      Low dose group: 30,000m NAU per injection of GEN0101 High dose group: 60,000m NAU per~     injection of GEN0101 Each group included minimal 3 subjects.~   "
81283|NCT02502981|"~     In stage 3 chronic kidney disease (CKD) the risk of death due to cardiovascular causes is~     high and greatly exceeds the risk of progression to end stage renal failure. This high~     cardiovascular risk is predominantly due to sudden cardiac death and heart failure,~     manifestations of left ventricular hypertrophy and fibrosis. Aldosterone appears to play an~     important role in the causation of this myocardial disease both by direct inflammatory and~     fibrotic myocardial effects and via increased arterial stiffness due to hypertrophy,~     inflammation, and fibrosis within the media of large arteries. Levels of aldosterone are high~     in CKD despite sodium overload and treatment with angiotensin-converting enzyme (ACE)~     inhibitor or angiotensin receptor blocker (ARB) drugs due to the twin phenomena of~     aldosterone escape and breakthrough. In a previous British Heart Foundation funded study,~     Birmingham investigators showed that the addition of the mineralocorticoid receptor blocker~     (MRB) spironolactone to background therapy with ACE inhibitors or ARBs caused reductions in~     the prognostically important parameters of arterial stiffness and LV mass. Because~     spironolactone therapy was also associated with significant falls in arterial pressure it~     remains possible that these effects were mediated simply by blood pressure reduction. In this~     multi-centre, randomised controlled study, the effects of treatment with spironolactone on LV~     mass and arterial stiffness in patients with stage 3 CKD on established ACE or ARB therapy~     will be compared to those of chlortalidone, a control anti-hypertensive agent. Early stage~     chronic kidney disease is highly prevalent and new, cost effective treatment strategies are~     required to reduce cardiovascular risk. This study is designed to provide the rationale for a~     larger study of morbidity and mortality with MRB therapy in early stage CKD.~   "
81284|NCT02502968|"~     This study evaluates the addition of BL-8040 to the standard consolidation therapy with~     cytarabine in the treatment of acute myeloid leukemia (AML) in adults. Half of participants~     will receive BL-8040 and cytarabine in combination, while the other half will receive placebo~     and cytarabine.~   "
81285|NCT02502955|"~     Today complex vascular and cardiological interventions are performed in severely ill~     patients.~      Autopsy is the reference standard for quality control for almost two centuries, but autopsy~     rates for patients dying in hospitals are decreasing rapidly.~      Virtual autopsy has shown to be a good alternative for classic autopsy.~   "
81337|NCT02502279|"~     General anesthesia lowers FRC thereby promoting airway closure and absorption atelectasis.~     Alveolar recruitment manoeuvers recruit collapsed alveoli, increase gas exchange, and improve~     arterial oxygenation.~   "
81286|NCT02502942|"~     Obstructive sleep apnea (OSA) is a common disorder characterized by recurrent collapse of the~     upper airway during sleep. OSA patients have a small upper airway that is kept patent during~     wakefulness by a compensatory increase in upper airway (UA) dilator muscle (e.g.~     genioglossus) activity. At sleep onset this compensation is reduced or lost, resulting in~     upper airway narrowing or collapse. Previous studies of upper airway muscle training showed~     variable results on OSA, but so far there has not been any practical, long-term, systematic~     upper airway muscle training developed or studied as the treatment of OSA. In theory,~     strengthening the upper airway muscle with exercise training in theory helps maintain a~     patent airway during sleep. Therefore, investigators aim to test the hypothesis: 1) UA muscle~     training can improve sleep apnea in some patients with OSA, including those already receiving~     treatment with PAP or oral appliance therapy. 2) Muscle training is a viable therapy for a~     definable subset of OSA patients. Investigators hypothesize that patients with OSA who have~     mild or moderately compromised upper airway anatomy will benefit the most. 3)There will be a~     positive association between the changes in muscle function and improvement in OSA severity.~   "
81287|NCT02502929|"~     The primary aim of the study is to compare the effect of three different interventions on~     lifestyle risk factors and biological risk factors for type 2 diabetes in depressed~     Cambodians. The three different interventions are lifestyle, lifestyle plus medication~     therapy management, and enhanced standard care.~   "
81288|NCT02502916|"~     The aim of this study is to evaluate the potential role of the enteral feeding systems on the~     bacterial colonization of premature infants during their NICU admittance and its evolution~     after 2 years, which is the age when the infant's gut starts to contain an adult-like~     microbiota.~   "
81289|NCT02502903|"~     Prospective, double-blind, randomized, placebo-controlled First-In-Human study with three~     sub-parts: Part A, a single ascending dose study (SAD) in normal human volunteers (NHVs),~     Part B, a multiple ascending dose study (MAD) in NHVs, Part C, a multiple dose (MD) study in~     patients with a complement-mediated disorder.~   "
81290|NCT02502890|"~     Asthma is a growing problem, especially in children. It causes frequent wheezing, shortness~     of breath, chest tightness, and cough. A cold that is caused by a virus (viral cold) can~     sometimes make asthma symptoms worse. This study will help investigators learn about the way~     colds are related to asthma attacks among children who need higher amounts of medications to~     control their asthma. Investigators want to learn why viral colds sometimes cause asthma~     attacks and other times do not by studying the immune system response in samples taken from~     the nose and blood.~   "
81291|NCT02502877|"~     The present study is a pilot study aiming to compare the variation in core temperature~     (measured through the non-invasive device Spot-OnTM3MTM) in patients submitted to neuraxial~     anesthesia for orthopedic procedures, during sedation with midazolam vs propofol.~   "
81292|NCT02502864|"~     The purpose of this study is to adjust the amount of docetaxel participants receive based on~     the level of docetaxel measured in their blood. This method of dose adjustment is called~     pharmacokinetic (PK)-adjusted docetaxel. The researchers believe that adjusting the dose of~     docetaxel using this method will lessen the side effects associated with docetaxel in cancer~     treatment.~   "
81293|NCT02502851|"~     The primary objective of this study is to evaluate the success of lesion preparation with~     either rotational atherectomy or cutting/scoring balloons as well as the long term effects of~     a hybrid sirolimus-eluting stent in an angiographically well-defined group of patients with~     complex calcified coronary lesions.~   "
81294|NCT02502838|"~     Pelvic organ prolapse (POP) is a common condition in women. Approximately 20% of women~     undergo surgical correction for POP in their lifetime. Overactive bladder symptoms (OAB) are~     often associated with POP in 25-69% of patients and POP has been shown to be an independent~     risk factor for OAB. There is scientific evidence that surgical repair of POP reduces or~     eliminates OAB in >85%. In addition, stress urinary incontinence (SUI) is also often~     associated with POP, either clinically evident or as a potential post-operative complication.~      The clinical decision as to include a surgical technique to treat SUI when repairing POP~     surgically is still a matter of controversy. Most surgeons at the institution will include an~     extra procedure, specifically a retropubic sling, if SUI is clinically evident. Some will not~     include it unless there is urodynamic or clinical evidence of potential SUI post-operatively.~     Finally, some will include it regardless of clinical or urodynamic findings based on the~     apparent high incidence of such SUI after prolapse repair. The Tension-Free-Vaginal Tape~     (TVT) has been observed to reduce OAB as well as produce de-novo OAB symptoms, so the effect~     of TVT on OAB is still unclear.~      The purpose of this study is to determine the effect of additional TVT surgery on OAB~     symptoms in patients undergoing POP repair. It is hoped that such data will better determine~     the effect of either surgical intervention strategy on OAB symptoms. This is a prospective~     cohort study comparing patients with OAB that undergo surgical repair of their prolapse with~     or without additional TVT surgery. The outcomes will be measured using pre- and~     post-operative validated questionnaires (PFDI-20, OAB-q short form).~   "
81295|NCT02502825|"~     The purpose of this study is to compare the diagnostic validity (sensitivity and specificity)~     and evaluate the safety of 2-min Tidal Breathing methacholine bronchial provocation tests~     with the Wright and Devilbiss646 nebulizers in asthmatic in Guangzhou.~   "
81296|NCT02502812|"~     Clopidogrel is a potent anti-thrombotic drug that inhibits adenosine diphosphate~     (ADP)-induced platelet aggregation. This is an open-label, randomized, single dose, three-way~     cross over, six sequence study to investigate the relative bioavailability of two 75~     milligrams (mg) clopidogrel tablet formulations (clopidogrel SB224326 test formulation 1~     [Clop F1] and clopidogrel SB224326 test formulation 2 [Clop F2]) compared with the reference~     product (innovator) in healthy human subjects. A total of 18 healthy human subjects will be~     randomized, such that approximately 14 evaluable subjects complete the study. Total duration~     in the study for each subject will be approximately 8 weeks from screening to the follow-up~     visit.~   "
81352|NCT02502084|"~     3NT flexible endoscope is a single-use disposable handheld endoscope that provides a means to~     visualize the nasal cavity and paranasal sinus space and deliver irrigation to treat the~     sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic~     procedures.~   "
98358|NCT02279784|"~     The aim of this study is to compare in patients with critical limb ischemia the efficacy of~     angioplasty with different paclitaxel-eluting balloon devices for below-the-knee lesions in~     terms of restenosis.~   "
81297|NCT02502799|"~     Individuals with ADHD are at markedly high risk for increased substance use and Substance Use~     Disorder (SUD). Given the strong evidence for the negative trajectory of individuals with~     co-occurring ADHD and substance use initiation, the goal of this study is to conduct a~     controlled examination of a brief, early intervention (BEI) for substance modified for~     adolescents with ADHD. Importantly, this intervention will address individuals who are at~     risk for problems with substance use, but do not yet meet criteria for severe SUD.~      Although brief interventions have been found to be effective in other populations, their~     efficacy in an ADHD population with emerging risk for substance use problems remains~     uninvestigated. This study aims to understand why some adolescents with ADHD and elevated~     risk for SUD respond to (BEI) and others do not. The investigators will test whether~     situational and individual characteristics predict substance use development and response to~     treatment. Further, this study will assess which types of additional treatment are most~     effective for youth who do not respond to the initial BEI. It is hypothesized that rates of~     adolescent substance use will be lower among adolescents who participate in study treatments.~   "
81298|NCT02502786|"~     The purpose of this study is to find out what effect an antibody called Humanized 3F8 (Hu3F8)~     and a drug called GM-CSF have on the patient and whether it can keep the patient in remission~     longer and/or prevent recurrence of the disease.~   "
81299|NCT02502773|"~     The primary purpose of the study is to evaluate whether the type of fluid (0.9% saline or 6%~     Hydroxyethyl starch 130/0.4) in the context of an individualized goal-directed fluid therapy~     is associated with a difference in morbidity and mortality within the first 14 days in~     patients at moderate-to-high risk of postoperative complications after abdominal surgery.~   "
81300|NCT02502760|"~     The purpose of this study is to determine if a program of physical activity, nutritional~     supplements and relaxation techniques is effective at decreasing post operative complications~     in frail colorectal cancer patients undergoing resection.~   "
81301|NCT02502747|"~     Study Objectives: To determine whether, in patients with large acute myocardial infarction~     undergoing primary or rescue angioplasty, the administration of subcutaneous Lenograstim~     [recombinant human Granulocyte-Colony Stimulating Factor (rhu G-CSF), Myelostim 34,~     Italfarmaco] associated with Myocardial Contrast Echocardiography and the intravenous~     infusion of sulphur hexafluoride (Sonovue, Bracco) determines an improvement:~        -  in regional and global contractile function, myocardial perfusion and infarct size~          assessed by cardiovascular magnetic resonance.~        -  Echocardiographic parameters of LV function~        -  in the serum profile of inflammatory and mobilizing cytokines and of biomarkers of~          myocardial damage and wall stress~   "
81302|NCT02502734|"~     This study will be conducted to evaluate the effect of once daily treatment with fluticasone~     furoate (FF) on lower leg growth in pediatric subjects with persistent asthma by using~     knemometry. Approximately 65 paediatric asthmatic subjects, aged 5 to 11 years (inclusive),~     will be screened to achieve 60 randomised and 50 evaluable subjects. Subjects meeting the~     eligibility criteria will enter the 2 week run-in period. After completing run-in period,~     each subject will be randomly allocated to one of two treatment sequences: inhaled~     fluticasone furoate followed by placebo or placebo followed by inhaled fluticasone furoate.~     Each treatment will be administered via the ELLIPTA™ dry powder inhaler. The two treatment~     periods will be separated by a two-week wash-out period. Subjects completing two treatment~     period will enter into 7 days follow-up period. ARNUITY™ ELLIPTA (FF) is approved in the US~     for adults and adolescents aged 12 and above.~      ARNUITY and ELLIPTA are a registered trademarks of the GlaxoSmithKline group of companies.~   "
81303|NCT02502721|"~     A randomized, open-labeled, oral dose, crossover design clinical trial to evaluate~     pharmacokinetics and safety between DWC20151 and DWC20152 in healthy male subjects.~   "
81304|NCT02502708|"~     This is a first-in-children phase 1 trial using indoximod, an inhibitor of the immune~     checkpoint pathway indoleamine 2,3-dioxygenase (IDO), in combination with~     temozolomide-based therapy to treat pediatric brain tumors. Using a preclinical glioblastoma~     model, it was recently shown that adding IDO-blocking drugs to temozolomide plus radiation~     significantly enhanced survival by driving a vigorous, tumordirected inflammatory response.~     This data provided the rationale for the companion adult phase 1 trial using indoximod~     (IND#120813) plus temozolomide to treat adults with glioblastoma, which is currently open~     (NCT02052648). The goal of this pediatric study is to bring IDO-based immunotherapy into the~     clinic for children with brain tumors. This study will provide a foundation for future~     pediatric trials testing indoximod combined with radiation and temozolomide in the up-front~     setting for patients with newly diagnosed central nervous system tumors.~   "
81305|NCT02502695|"~     This is a research study for participants who have been diagnosed with lung cancer and are~     receiving VATS (Video Assisted Thoracoscopic Surgery) lobectomy or segmentectomy. The overall~     objective of this study is to develop a database to collect data on participants who are~     undergoing VATS lobectomy or segmentectomy for lung cancer.~   "
81306|NCT02502682|"~     Clostridium difficile (C. diff.) infections, whether nosocomial or community borne, may~     present with profound diarrhea, especially in those patients receiving antibiotics. Based on~     a preliminary review of hospital data, the investigators have found that these symptomatic c.~     diff infections occur with a relatively high incidence at Delnor Hospital. Notwithstanding~     their high mortality, one recent study attributes a near quadrupling of hospitalization costs~     to c. diff infections. Chlorhexidine baths have been shown in multiple randomized trials to~     help reduce the incidence of highly virulent pathogens and hospital acquired infections.~     Further, several studies show a favorable effect of reducing the incidence of c. diff~     infections by using Chlorhexidine baths on ICU patients. Far fewer studies, however, have~     focused on the effects of these baths on general medical/surgical wards. This investigation~     seeks to study the effect of the daily use of 2% Chlorhexidine gluconate wipes in patients on~     the general medical/surgical wards who are exposed to antibiotics for a suspected or~     confirmed infection.~   "
81307|NCT02502669|"~     Double-blind, randomized, placebo-controlled, dose-ranging study to evaluate the efficacy and~     safety of once weekly, high dose oral finasteride compared to placebo for the treatment of~     severe nodulocystic acne in male subjects.~   "
81308|NCT02502656|"~     This study will evaluate the concordance of RAS mutation detection between the results~     obtained from circulating tumor DNA and those obtained with the standard method (testing~     from tumor tissue).~   "
81309|NCT02502643|"~     The purpose of this study is (1) The success rate of OK-432 pleurodesis after thoracic~     surgery that air leak over 48 hours (2)The side effects and treatments of OK-432 pleurodesis.~      [Methods] This study was a prospective, randomized, open-label, controlled study to evaluate~     the effectiveness of OK-432 pleurodesis of persistent air Leak after pulmonary Resection. The~     adult patient have persistent air leak >48 hours after thoracic surgery, will randomized to~     OK-432 pleurodesis (OK-432 group) or normal saline pleurodesis (NS group). The trial will be~     conduct from May 25, 2015 to May 25, 2018 in the Department of Surgery at national Taiwan~     University Hospital, a medical center. The study protocol was approved by the hospitals'~     Institutional Review Boards. A total of 80 cases, the subjects will be the hospital thoracic~     surgery ward and received outpatient programs. Eligible Subjects : adults (minimum age> 20~     years; maximum age ≦ 70 years old) patients with thoracic surgery and over48 hours of~     continuous air leak. The exclusion criteria include: penicillin allergy,primary pneumothorax,~     esophageal cancer, immune dysfunction, those who can not sign a consent form, and pregnant or~     lactating, other serious concomitant illness such as uremia or liver cirrhosis. Study steps:~     eligible Patients will randomize according to computer-generated random numbers, with 1:1~     ratio in sequentially numbered, sealed envelopes by a study nurse who was masked to the~     study. Randomization envelopes were opened, and randomization was performed by the study~     nurse after informed consent was obtain. Eligible inpatients were randomized to the OK-432~     group or the normal saline (NS) group，each group are 40 cases.~      All subjects were observed by the physician who was masked to the study， about air leak stop~     time, chest tube removal time, discharge time, outpatient chest X-ray, pulmonary function~     tests as necessary. cases if persistent air leak more than seven days, the attending~     physician determines whether pleurodesis again or surgery or other medical treatment.~     Finally, the researcher who do not know groups will collection data by air leak case record~     form including diagnosis, surgical site，the start and end time of the surgery, the use of~     antibiotics, discomfort problems (pain , stomach discomfort, cough, fever> 38 ℃, allergic~     reactions and respiratory discomfort), postoperative air leak time, air leak stop time ,~     chest tube removal time, discharge time, the data will be use SPSS20.0 version of the~     statistical software package, and T-test, pair T-test ，Anova ,linear correlation statistical~     methods for analysis.~      Outcome measures: OK-432 success rate, OK-432 side effects, air leak time, chest tube remove~     time, length of hospital stay.~   "
81310|NCT02502630|"~     (MWA) is the most recent development in the field of local ablative therapies. The aim of~     this study was to evaluate CT-guided percutaneous microwave (MW) ablation safety and efficacy~     in pulmonary metastases from colorectal cancer.~   "
81311|NCT02502617|"~     In anorexia nervosa (AN) it still remains to be clarified, which psychiatric symptoms are the~     direct consequence of malnutrition and adaptation to starvation and which are not. There is~     clinical consensus that depression/anxiety and cognitive impairments in AN mainly are~     sequelae to the malnutrition. However, this consensus is largely based on experimental~     starvation studies of healthy subjects back in 1940s and from famine- and food programs in~     the third world, whereas evidence from studies on AN is lacking.~      The main objective of the study is in the detail to elucidate the short-term changes in the~     psychopathological profile, depression, anxiety, and cognitive functions in relations to~     intensive nutritional rehabilitation with weight gain of 10-30% in a specialized medical~     stabilization unit. Secondarily, it is examined whether cortisol levels are associated with~     depression/anxiety symptomatology and cognitive impairments. The hypothesis is that an~     improvement in nutritional status over a short time leads to clinically significant~     improvements in psychopathology and cognitive functions, which remain 2-3 months after~     discharge, making the patients more accessible to psychotherapy.~   "
81312|NCT02502604|"~     Individuals with affective disorders (including post-traumatic stress disorder (PTSD) and~     major depressive disorder (MDD)) often experience declines in cognitive abilities such as~     memory and attention. Such difficulties can reduce functioning in important aspects of life,~     including at work or school. Little research has been conducted to investigate if cognitive~     dysfunction can be reduced in individuals with PTSD or MDD following a specific treatment.~     Thus, the investigators plan to determine the utility of a cognitive training program called~     goal management training (GMT) in reducing cognitive dysfunction in MDD/PTSD. GMT aims to~     assist participants in building skills in performing specific behaviours that rely on basic~     cognitive processes, allowing them to achieve an identified goal. 64 individuals with PTSD~     and 64 with MDD will be divided into two groups of 32, one GMT group, and one wait-list group~     that will receive GMT after study completion. The investigators predict that in comparison to~     the wait-list group, the GMT group will show greater improvements in cognitive functioning~     and everyday functioning following treatment and that these improvements will remain~     long-term.~   "
81313|NCT02502591|"~     Rectocoele or a posterior vaginal prolapse (bulge in the vagina) is a frequent gynaecological~     condition. It is repaired by repairing and reinforcing the support to the vaginal wall at the~     back. A small cut is made through the lining of the back wall of the vagina. The supports to~     the rectum are reinforced with stitches and the bulging part of the vaginal wall cut away.~     The wound in the vagina is then stitched up. Rectocoele repair is usually carried under a~     general anaesthetic with women reporting moderate to severe degrees of pain post operatively~     on sitting down.~      A Pudendal Nerve Block (PNB) is a common analgesic (pain killing) technique often used for~     women who need an instrumental delivery during childbirth. It is also widely used during a~     range of surgical procedures (operations) as a preventive analgesia to help reducing post~     -operative pain. The investigators would like to see if using this technique during routine~     rectocele repair will help with post - op pain.~   "
81314|NCT02502578|"~     The purpose of this study is to assess the safety and to examine the index of the efficacy~     after repeated dosing of CNT-01 in patients with idiopathic triglyceride deposit~     cardiomyovasculopathy.~   "
81315|NCT02502565|"~     An observational study to evaluate the prevalence of US changes of gout in the joints and~     tendons of patients with different degrees of asymptomatic hyperuricemia. The investigators'~     findings may support the extension of the spectrum of urate disease, and define a subset of~     patients that may benefit from early urate-lowering therapy.~   "
81338|NCT02502266|"~     This randomized phase II/III trial studies how well cediranib maleate and olaparib work when~     given together or separately, and compares them to standard chemotherapy in treating patients~     with ovarian, fallopian tube, or primary peritoneal cancer that has returned after receiving~     chemotherapy with drugs that contain platinum (platinum-resistant) or continued to grow while~     being treated with platinum-based chemotherapy drugs (platinum-refractory). Cediranib maleate~     and olaparib may stop the growth of tumor cells by blocking enzymes needed for cell growth.~     Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either~     by killing the cells, by stopping them from dividing, or by stopping them from spreading. It~     is not yet known whether giving cediranib maleate and olaparib together may cause more damage~     to cancer cells when compared to either drug alone or standard chemotherapy.~   "
81353|NCT02502071|"~     The purpose of this study is to determine whether alkalinization of urine uric acid by 2~     doses of sodium bicarbonate (1950mg) over 24-hours reduces precipitation and crystallization~     of urine uric acid over in adults with type 1 diabetes.~   "
81316|NCT02502552|"~     Prognostic factors in Inflammatory Bowel Diseases (IBD) are currently mainly based on~     clinical factors (disease extension, perianal involvement, need for surgery, use of~     immunomodulators…). All of immunological markers (or serological) of IBD have a diagnostic~     role in indeterminate colitis (ulcerative colitis vs crohn's disease) but they never have~     been considered as predictors of IBD course in adults. Among the most used, anti-neutrophil~     cytoplasm antibodies (ANCA) and Anti-Saccaromyces cerevisiae antibodies (ASCA) allow the~     distinction between ulcerative colitis (ANCA+/ASCA-) and Crohn's disease (ANCA-/ASCA+), and~     their combined use has a sensitivity and a specificity of about 85%. However, 10 other~     antibodies have been identified and recently evaluated individually in IBD and especially in~     pediatric Crohn's disease: anti-ompC, anti-I2, anti-flagellins, anti-glycan~     (anti-laminaribioside carbohydrate antibodies (ALCA), anti-mannobioside carbohydrate~     antibodies (AMCA), anti-chitobioside carbohydrate antibody (ACCA), anti-chitin and~     anti-laminarin), anti-goblet cells and anti-C.albicans specific mannans antibodies. These~     complementary tests improve the reliability of the diagnosis. In a previous cross-sectional~     work on a cohort of 195 IBD patients, the investigator showed a prognostic role of some of~     anti-glycan Abs and especially a correlation with a pejorative form of the disease both in~     Crohn's disease than in Ulcerative Colitis (UC) and a prediction of corticodependency in IBD.~   "
81317|NCT02502539|"~     Juvenile idiopathic arthritis (JIA) is a chronic disease characterized by persistent joint~     inflammation. The immune system disruption that leads to overproduction of pro-inflammatory~     cytokines (TNF-α, IL-1, IL-6) is a cascade of events on different levels—some molecular, some~     cellular, and some systemic. Our objective is to identify the mechanisms through which~     physical activity is liable to mediate inflammatory balance in autoimmune disease settings,~     and specifically in JIA patients.~   "
81318|NCT02502526|"~     The purpose of this study is to demonstrate that the Centurion® Vision System (CVS) used with~     the 45° Balanced Tip will result in less Cumulative Dissipated Energy (CDE) than the~     lnfiniti® Vision System (IVS) used with the 45° Mini-Flared Kelman (MFK) tip during cataract~     extraction surgery via phacoemulsification of cataract grades NII- NIV [Lens opacities~     classification system II (LOCSII)].~   "
81319|NCT02502513|"~     This pilot study aims to investigate the effects of a brief computerized intervention (the~     computer game Tetris) on intrusive memories and other posttraumatic stress symptoms~     following an emergency cesarean section. Patients who have undergone an emergency cesarian~     section will be randomly allocated to either the brief computerized intervention or usual~     care within the first 6 hours following the operation. Participants will be followed up at~     one week and one month. It is predicted that participants given the brief computerized~     intervention will develop fewer intrusive memories and less severe clinical symptoms than~     those who are not. This will inform the potential future development of a simple computerized~     intervention to prevent distressing psychological symptoms after a traumatic event such as an~     emergency cesarean section.~   "
81320|NCT02502500|"~     To assess the single dose pharmacokinetics (PK) of celecoxib in healthy subjects when~     administered alone and following multiple daily doses of AKB-6548.~   "
81321|NCT02502487|"~     This study will determine the effectiveness and safety of dorsal penile nerve block (DPNB) in~     men undergoing rigid cystoscopy.~   "
81322|NCT02502474|"~     Epidemiological study aiming to describe the carriage (nasal, throat, groin, rectal and~     colonic) of S. aureus in patients without chronic digestive disease who are going to have a~     colonoscopy for cancer screening. The carriage will be analyzed globally and the similarity~     of strains isolated from each site will be analyzed using molecular tools. The aim of this~     study is to better estimate the digestive reservoir of S. aureus to better prevent endogenous~     infections due to this bacterium.~   "
81323|NCT02502461|"~     Correct endotracheal tube (ETT) placement is important. Proper ETT position is achieved when~     the distal tip is in mid-trachea with the head in neutral alignment. Unrecognized tube~     misplacement is an uncommon but significant cause of hypoxemia and death during general~     anesthesia as well as in the care of critically ill patients.~      Hypotheses: A specific manoeuvre to palpate the inflated ETT cuff, with fingers anterior to~     the trachea, moving the ETT caudally then rostrally following intubation, will enable correct~     depth placement of the tip of the ETT within the trachea (more than 2.5cm above the carina~     with cuff below the vocal cords) more frequently than routine care. This will not cause~     tissue damage as measured by sore throat.~   "
81324|NCT02502448|"~     Impact of acute normovolemic hemodilution (ANH) using hydroxyethyl starch before initiating~     cardiopulmonary bypass (CPB) on whole blood viscoelastic profile after CPB has not been well~     established.~      Patients undergoing cardiac surgery employing moderate hypothermic CPB (n=40) are randomly~     allocated into one of two groups: in Group-ANH(n=20), ANH is applied by using a balanced~     hydroxyethyl starch (HES 130/0.6); and in Group-C, ANH is not applied.~      After weaning from CPB, intergroup differences of INTEM, EXTEM, FIBTEM and APTEM profiles are~     analyzed.~      As a primary outcome, inter-group difference between maxiaml clot firmness of EXTEM will be~     determined at 10 min after ANH in Group-ANH and that at control.~   "
81325|NCT02502435|"~     This study wishes to look at the 24-hour rhythm of certain fats in the blood stream. Recent~     studies in animals and healthy participants suggest that unusual eating habits may be~     connected to a change in the 24-hour rhythm of the blood fats the investigators wish to~     measure. The investigators will ask persons suffering from night eating syndrome, a condition~     where people eat additional meals throughout the night, to participate in this study. Healthy~     volunteers who are of the same age and gender, and have a comparable body-mass-index, a~     number calculated from a person's weight and height, will also be asked to participate.~      The aim is to learn how the 24-hour rhythm of the blood fats the investigators measure~     differs between the persons experiencing the night eating episodes and persons who do not.~   "
81326|NCT02502422|"~     Overinflation of laryngeal mask airway cuff increase side effect like hoarseness, vocal cord~     paralysis, sorethroat. The investigators will study correlation between laryngeal mask airway~     cuff volume and pressure and physical examination of head and neck.~   "
81351|NCT02502097|"~     A randomized, double-blind, placebo-controlled, crossover, dose escalation study of~     gefapixant (AF-219) in participants with Idiopathic Pulmonary Fibrosis (IPF) with persistent~     cough.~   "
81330|NCT02502370|"~     The utility of adjuvant chemotherapy in the management of Small Bowel Adenocarcinoma (SBA)~     remains unproven and awaits the results of a large, global, prospective, phase III,~     randomised, controlled trial. Across the 830 million population of North America and Europe,~     there are approximately 3,000 patients with stage I-III SBA every year who would be~     potentially eligible for such an adjuvant chemotherapy trial.~      Given the absence of good-quality and evidence-based data, it has been agreed that a trial~     considering adjuvant chemotherapy versus no chemotherapy was appropriate for patients with~     stage I-III SBA in whom the oncologist and patient feel that the benefit of adjuvant~     chemotherapy is uncertain. For those patients with stage I-III SBA who, with their~     oncologists, feel that the potential benefit of adjuvant chemotherapy is certain (and hence~     are not willing to accept randomisation to the 'no chemotherapy' arm), a randomisation~     between single agent fluoropyrimidine versus doublet fluoropyrimidine and oxaliplatin~     chemotherapy will be offered. Tumour stage will be used as a stratification factor. Those~     patients who do not consent to be randomised will be offered registration to allow collection~     of demographic, clinicopathological and survival data, thereby making optimal use of the rare~     patient population available. In addition, archival Formalin Fixed Paraffin Embedded (FFPE)~     tissue and contemporaneous venous blood samples will be collected from every registered~     patient to allow molecular profiling and future translational research. A questionnaire about~     underlying risk factors (e.g. Crohn's disease, coeliac disease, Lynch syndrome etc) will be~     completed along with the other collected data on all registered patients.~   "
81331|NCT02502357|"~     This is a randomized clinical trial comparing the severity of post-operative pain and use of~     pain medication in women who are and are not exposed to healing statements before undergoing~     vaginal hysterectomy with minimally invasive sacrocolpopexy. The investigators' hypothesis is~     that those who are read healing statements before surgery will require less post-operative~     pain medications and experience less severe pain than those who do not hear the statements.~   "
81332|NCT02502344|"~     This research would take medical interventions in subjects of insulin resistance without~     abnormal glucose tolerance, to see if there were different prevalence of abnormal glucose~     tolerance in different groups.~   "
81333|NCT02502331|"~     -  Number of doses and intervals: Two doses, 2 weeks apart~        -  Method of administration: Oral administration~        -  Volume of vaccine to be administered: 1.5 mL/dose~        -  Observational period: 4 weeks (2 weeks after each dose)~        -  Number of visits: 3 visits~             1. Visit 1: Screening and enrollment (1st dosing)~             2. Visit 2: 2nd dosing 2 weeks after 1st dose (14+3 days)~             3. Visit 3: 2 weeks after the 2nd dose (28+3 days), end of subject participation. This~               study will be carried out in healthy adults and children, at two sites, enrollment~               will be competitive between the sites. Subjects will be stratified according to age~               into adults (18~40 years of age) and children (1~17 years of age). According to the~               pre-generated randomization list, the participants will be randomized to the test~               or comparator groups (Visit 1) and will be given either the test vaccine or the~               comparator vaccine. For immunogenicity assessment, blood sample will be taken at~               Visit 1 (prior to vaccination), Visit 2 (prior to vaccination), and at the~               end-of-study Visit (Visit 3). For Safety assessment: the participants will be~               observed for 30 minutes post vaccination and instructed to record solicited adverse~               events that occur up to 6 days after vaccination on the participant diary card.~      This study is observer-blind: vaccine administrator and vaccine safety evaluator will be two~     distinct persons to avoid bias of safety assessment. Trial staff other than the vaccine~     administrator will remain blinded and will not handle the investigational product.~   "
81334|NCT02502318|"~     This is a national study that involves the participation of 600 lung cancer patients~     indicated that treatment is ablation of the pulmonary lobe. This technique is called~     lobectomy.~      Lobectomy may be performed in two different ways:~        -  Thoracotomy, which is the first reference approach and that is to make a large incision~          in the chest to pass between the ribs and spread the order to ablate the lobe.~        -  By video-thoracoscopy, which is a new surgical approach consisting in practice several~          small incisions in the chest wall to allow the introduction of a camera and special~          instruments to ablate the lobe.~      The mini-invasive nature of video-thoracoscopy has a positive impact on postoperative~     expectoration and ventilation. As a result, the incidence of postoperative respiratory~     complications including atelectasis, pneumonia and Acute Respiratory Distress Syndrome (ARDS)~     is reduced. These respiratory complications are responsible for prolonged stays in Intensive~     Care Unit (ICU) and overall hospitalisation. It also has an impact on recovery and quality of~     life when patients return home. The reduction in the incidence of complications should~     counterbalance the additional cost of video-thoracoscopy.~      This study aims to evaluate the effectiveness of these two techniques in relation to the~     quality of life and the costs they generate.~      Patients who agree to participate in the study were assigned to one or other of these groups~     (technical thoracotomy or video-thoracoscopy technique) by lot.~   "
81335|NCT02502305|"~     Aim of the study is to find out if the live online course is effective with regard to health~     promotion. Older adults receive support to initiate a health behavior (i.e., to enhance~     physical activity or to improve food habits).~      Motivation, confidence and self-management strategies are optimized to make sure participants~     are able to integrate the physical activity or healthy diet into their daily life.~   "
81336|NCT02502292|"~     In this study, the investigators evaluate an intervention aiming to increase participation~     and communication of older adults during primary care consultations with their General~     Practitioner(GP). The investigators are particularly interested in a Photo novel tool with~     this aim. Photo novels are picture stories, which have the advantage of using a familiar~     narrative format, thereby possibly increasing comprehension, personal involvement and~     motivation and self-efficacy to perform the relevant behaviors by offering role models (story~     characters that are similar to older adults themselves). The patient perspective on~     doctor-patient communication is underrepresented in most research. This study aims to~     incorporate the patient perspective in different ways: in addressing their needs and barriers~     during focus group discussions, in collecting their communication strategies and solutions to~     these barriers in the role play exercise, in involving them in developing the photo novel,~     and in studying their responses to the photo novel in the evaluation study the investigators~     describe in this research proposal.~   "
81339|NCT02502253|"~     Mild Cognitive Impairment (MCI) represents a group of persons who are at risk of incident~     dementia in the near-term. Persons with MCI who have deficits in short-term recall (amnestic~     MCI) are at significant risk of incident Alzheimer's disease (AD) (termed prodromal AD), and~     thus represent a worthy target for secondary prevention interventions.~      There is increasing evidence that risk factors for metabolic syndrome (such as prediabetes~     and type 2 diabetes) increase risk of incident cognitive impairment and possibly AD, and~     evidence that the neurons of the AD brain are in fact insulin resistant with diminished~     glucose uptake under physiological conditions. Thus, persons with MCI and prediabetes or type~     2 diabetes may be at particular risk of incident cognitive impairment and AD.~      A large clinical trial (ACCORD)1 demonstrated that tight control of peripheral blood glucose~     does not improve cognitive (or other health) outcomes in older persons with peripheral~     insulin resistance. Thus, there is a need to target cognitive outcomes in persons with MCI~     and metabolic risk factors, and a drug targeting insulin resistance with good~     blood-brain-barrier (BBB) penetrance can potentially accomplish these objectives. While there~     is a phase III study of intranasal insulin targeting this strategy, nutraceuticals offer a~     low-tech solution that would be more suitable to future secondary prevention trials in MCI.~      Bioactive Dietary Polyphenol Preparation (BDPP) is a combination of two nutraceutical~     preparations grape seed polyphenolic extract (GSE), and resveratrol that contain abundant~     concentrations of polyphenols. The investigators have found that oral BDPP administration was~     associated with improved cognition and brain plasticity long-term potentiation (LTP) in mouse~     models of metabolic syndrome and AD, as well as lowering brain amyloid and tau burden in an~     AD mouse model2-4. The investigators have demonstrated excellent absorption of oral BDPP in a~     small study in humans and similarly excellent CSF penetration of oral BDPP in rats, but it is~     crucial to demonstrate safety and CSF penetration of oral BDPP in humans to assess its~     potential as a treatment for MCI and prediabetes or type 2 diabetes.~   "
81340|NCT02502240|"~     Evaluation of the frequency and clinical characteristics of ALK rearrangements in~     Latin-American countries.~      Latin American countries are heterogeneous in terms of lung cancer incidence, ethnicity, and~     exposure to potential carcinogens. The discovery of the echinoderm microtubule-associated~     protein like 4-anaplastic lymphoma kinase (EML4-ALK) translocation as an oncogenic driver has~     led to the development of novel therapies with activity in vitro and in the clinic.~   "
81341|NCT02502227|"~     This study is a three-arm randomized controlled trial of a mindfulness stress reduction~     intervention, with the aim of dismantling the experience-monitoring and~     nonjudgmental-acceptance elements of mindfulness programs to determine the active treatment~     component. In addition to enhancing understanding of mechanisms underlying the effects of~     mindfulness interventions, identifying the therapeutic constituent(s) could inform~     development of targeted interventions as well as provide strategies to optimize adherence.~   "
81342|NCT02502214|"~     Preimplantation Genetic Diagnosis (PGD) for monogenic diseases is usually performed by~     multiplex PCR combining polymorphic microsatellites familial analysis and, where possible,~     couple-specific mutation detection. Single-cell multiplex PCR developments are costly and~     time-consuming. We propose to test and clinically validate a targeted next-generation~     sequencing approach for the PGD for cystic fibrosis. This technique would allow a PGD for~     probably almost every couple asking for it in our centre, without a previous couple-specific~     development (but only a preliminary familial analysis). It will be based on haplotyping using~     a large number of SNPs and mutation detection. A clinical validation will be performed by~     reanalysing non-transferable embryos obtained after PGD for cystic fibrosis, with couple's~     informed consent. Concordance of the results between PGD and reanalysis by NGS will be~     achieved and if validated, this technique may be applied to future PGD for cystic fibrosis in~     our centre. The same technique may then be applied for other PGD indications for which a~     set-up is often needed.~   "
81343|NCT02502201|"~     The purpose of this research study is to determine the effect of the environment on~     six-minute walk test performance in individuals with chronic obstructive pulmonary disease~     due to alpha-1 antitrypsin deficiency. The aim of the study is to determine the environmental~     impact on physical performance in this population to determine if any factors influence~     quality of life. This study was developed to evaluate the efficacy of the using the indoor~     six-minute walk test to determine eligibility for ambulatory oxygen therapy.~   "
81344|NCT02502188|"~     To evaluate the safety, tolerability, and pharmacokinetics of single and multiple doses of~     CC-90005 in healthy subjects and subjects with moderate to severe plaque-type psoriasis.~   "
81345|NCT02502175|"~     Patients with opioid use disorder seeking medication-assisted treatment will be recruited.~     Each participant will be allocated to one of the two study groups with the equal chance of~     receiving either opium tincture (OT) or methadone. Participants, clinical and research staff~     will not be aware of the medication that each patient receives. This study aims to test~     whether OT is as equally effective as methadone at retaining participants with opioid use~     disorder in medication-assisted treatment.~   "
81346|NCT02502162|"~     The investigators are testing treatment with low-dose naltrexone (LDN) for symptom relief of~     complex regional pain syndrome (CRPS). Study participants will be randomly assigned to~     receive either LDN or placebo for a period of several weeks. During this period participants~     will be asked to come to several visits, which will include sensory testing, physical~     assessments, and questionnaires.~   "
81347|NCT02502149|"~     The primary objective of the study is to compare the pharmacokinetic (PK) of recombinant~     coagulation factor VIII Fc fusion protein (rFVIIIFc) manufactured at the current scale of~     2000 L (2K) to the PK of rFVIIIFc manufactured at the 15,000 L (15K) scale in previously~     treated participants with severe hemophilia A. The secondary objectives are: to characterize~     the PK of rFVIIIFc manufactured at the 15K scale at the 15K baseline and after 13 weeks of~     treatment; to characterize the PK of rFVIIIFc manufactured at the 15K scale at 1000 IU/vial~     and 6000 IU/vial strengths; and to evaluate the safety of rFVIIIFc manufactured at the 15K~     scale.~   "
81348|NCT02502136|"~     The purpose of this study is to assess the differences of safety and efficacy of carbon~     dioxide insufflation instead of air during sedated or unsedated endoscopy.~   "
81349|NCT02502123|"~     This study will prospectively assess long term heath related quality of life in chronic~     migraine patients currently being treated with OnabotulinumtoxinA for injection (BOTOX®) as~     standard of care.~   "
81350|NCT02502110|"~     The study will select all recruited patients with paroxysmal atrial fibrillation will be~     randomly allocated to receive oral rosuvastatin 20mg/day or blank control from 7 days before~     ablation and last for 3 months. To observe the early relapse of atrial fibrillation and the~     changes of white blood cell count, hs-C reactive protein (CRP), interleukin (IL)-6 and tumor~     necrosis factor (TNF)-α, and the changes of safety indicators .~      This study assumes that the early atrial fibrillation (AF) recurrence will be decreased in~     patients with paroxysmal AF if rosuvastatin 20mg/d is received from 7 days before surgery in~     these patients who plan to undergo radiofrequency catheter ablation for consecutive 3 months.~   "
81354|NCT02502058|"~     The primary objective of this study is to determine if the use of a bone compaction process~     (osseodensification) (Densah™ bur: Versah Osseodensification Company™) to prepare dental~     implant sites, in human subjects, results in increased bone-ridge width, increased compact~     bone in the outer wall of the prepared sites, and dental implant stability.~   "
81355|NCT02502045|"~     Determine effect and duration of effect of timed therapeutic light compared to control light~     on parameters of circadian rhythmicity, physiologic plasticity, sleep, and global function in~     women with Alzheimer's Disease.~   "
81356|NCT02502032|"~     To investigate the effects of different doses of cisatracurium pretreatment on~     succinylcholine-induced fasciculations.~   "
81357|NCT02502019|"~     The primary objective of this pilot clinical investigation is to assess the reliability of~     the Surface Bleeding Severity Scale (SBSS) in a clinical setting. Secondary objectives of~     this clinical investigation are to collect initial data on the safety and efficacy of~     HEMOBLAST™ Bellows in abdominal and orthopedic lower extremity surgeries.~   "
81358|NCT02502006|"~     This research study will evaluate inter-individual variability in the response to the~     non-steroidal anti-inflammatory drugs (NSAIDs), celecoxib and naproxen, among healthy adults.~     It will also investigate what factors, like age, sex, or genetic background, cause this~     variability.~   "
81359|NCT02501993|"~     The primary objective is to determine the early diagnosis rate and mortality rate of the~     Nasopharyngeal Carcinoma (NPC) in the study population.~      The secondary objective is to determine the incidence of NPC in the study population.~   "
81360|NCT02501980|"~     All participants in the selected communities will be tested for HBsAg by using serum samples.~     Among those who are positive for HBsAg, further clinical work-ups including AFP test and~     ultrasonography for liver exam will be performed. High risk group will be selected according~     to the definition. HCC diagnosis will be determined according to imaging and/or biopsy~     result. Repeated check-ups will be performed in 6-months among HBsAg positive group and~     3-years among HBsAg negative group.~      All subjects in the control arm (control communities) will be followed by record linkage to~     Cancer Register and Population Register.~   "
81361|NCT02501967|"~     The purpose of the proposed project is to pilot-test in the clinic setting a computer-based~     clinical decision support system (CDSS) designed to optimize medication prescribing for older~     persons with multiple chronic conditions and polypharmacy.~   "
81362|NCT02501954|"~     To determine if treatment with cisplatin and radiation followed by carbo and taxol reduces~     the rate of recurrence when compared to sandwich therapy.~   "
81363|NCT02501941|"~     Hypothesis: Cortical spreading depolarizations are inhibited by the NMDA receptor antagonist~     Ketamine Aim 1: To demonstrate, in a group of patients with acute severe brain injury~     requiring surgery including traumatic brain injury and aneurysmal subarachnoid hemorrhage,~     whether use of continuous infusion of ketamine decreases frequency of occurrence of cortical~     spreading depolarizations.~   "
81364|NCT02501928|"~     The purpose of this study is to investigate the safety and tolerability of fesoterodine~     following once daily long-term treatment in Japanese pediatric neurogenic detrusor~     overactivity (NDO) subjects.~   "
81365|NCT02501915|"~     The Kinesio Taping (KT ) method was developed more than thirty years ago in order to cause~     sensory effects through the epidermis and dermis, generating a variety of physiological~     effects in other systems. Clinical effects are well known levels in muscle, neurological~     system, injuries, inflammation, edema, among other physiological effects are thus largely in~     the theoretical framework. Objectives: The aim of this study is to evaluate the~     Electromyographic (EMG), Electroencephalographic (EEG), muscle temperature and flexibility~     effects with the Rectus Femoral muscle KT application. Methods: This is a pilot study with~     six subjects in which they were divided into two groups, A and B. Group A received the~     application of KT from muscle Origin to Insertion and group B Insertion to Origin, with both~     groups taped the non-dominant limb and the dominant limb was used as control group. The first~     application was conducted at 0% and the second with 75 to 100% tension. Evaluations were~     performed before the first application, immediately and 24 hours later. After this last~     evaluation, was withdrawn taping, evaluated without taping, reapplied 75 to 100 % of rated~     voltage and in sequence. The sixth last review was conducted 24 hours after this last~     application. Before every application a specific vibration was performed on the patellar~     tendon in order to trigger a neurophysiological imbalance rectus femoral.~   "
81366|NCT02501902|"~     This is a Phase 1, open label, multi center, multiple dose, dose escalation, safety,~     pharmacokinetic and pharmacodynamic study of palbociclib in combination with nab-P, in~     sequential cohorts of adult patients with mPDAC, with MTD expansion cohort(s). Approximately~     30-60 patients are expected to be enrolled in the overall study.~   "
81367|NCT02501889|"~     This study investigates whether walnuts help to promote weight loss, associated with~     increased meal satiety and satisfaction, in 100 overweight and obese men and women who are~     participating in a 6-month behavioral weight loss intervention. Participants will be randomly~     assigned to a walnut-enriched reduced-calorie diet or a standard reduced-calorie diet. Body~     weight, risk factors for cardiovascular disease, and self-reported feelings relevant to~     satiety and appetite will be measured at baseline and 3- and 6-month follow-up. Also, the~     response of gastrointestinal tract hormones following meals with or without walnuts will be~     measured in a subset of study participants (n=20). Results from this study will contribute to~     understanding the role of nuts in weight control, including further knowledge of the~     mechanisms, and will expand knowledge of how nuts in the diet may contribute to the~     prevention and management of obesity.~   "
81368|NCT02501876|"~     In recent years, it has been observed that the type 2 diabetic patients (DM-2) have an~     increased risk of developing dementia, both vascular and Alzheimer's disease (AD). The term~     mild cognitive impairment (MCI) describes a transition state between normal cognitive~     function and dementia. The annual rate of conversion to dementia in MCI patients is around~     15% in the general population, regardless of the presence or absence of diabetes. At present~     it is not possible to identify which patients with MCI are most likely to progress to AD. On~     this basis, the main objective of this study is to evaluate whether the presence of diabetes~     and or the presence of its related genes favors the conversion of MCI to AD.~   "
81369|NCT02501863|"~     The postoperative analgesic effect of the continuous 3-in-1 femoral nerve block (FNB) with~     ropivacaine/fentanyl or with ropivacaine were compared in total knee arthroplasty.~   "
81370|NCT02501850|"~     Lipoprotein (a) [Lp (a)] is an independent cardiovascular risk (CVR) both in the general~     population and in patients with type 2 diabetes mellitus (DM-2). Until now no effective~     treatment is known to decrease the levels of Lp (a) levels and thus achieve a reduction of~     CVR. Among the new antidiabetic drugs are GLP-1Receptor agonists(GLP-1R). In addition to~     lowering blood glucose, these drugs have other beneficial effects. In our laboratory we have~     demonstrated that both native GLP-1 and various GLP-1R agonsits reduce the synthesis of Lp~     (a) in hepatocytes. The objective of the study is to test in humans the results observed in~     vitro. We will analyze whether treatment with GLP-1R agonists (Liraglutide, Exenatide or~     Lixisenatida) will reduce serum levels of Lp (a) in patients with DM-2.~   "
81371|NCT02501837|"~     The neuropeptide oxytocin (OXT) has been identified as a key modulator of human social~     behavior and it has been recently shown that OXT also contributes to pair-bonding in men.~     However, it is still elusive whether OXT has similar effects in women. In the present study,~     the investigators examine the effect of intranasal OXT on behavioral ratings of and neural~     responses to the male partner in female participants. In a second experiment, the modulatory~     effect of OXT on emotion regulation is investigated.~   "
81372|NCT02501824|"~     Anthroposophic therapeutic speech is a complementary method that indirectly influences~     breathing and uses specific vowels, consonants, syllables and metres depending on the~     indication. The aim of this study is to test the effectiveness of anthroposophic therapeutic~     speech in patients with asthma regarding clinical and physiological parameters, asthma~     control and quality of life.~   "
81373|NCT02501811|"~     This is a phase II, randomized, placebo-controlled clinical trial designed to assess~     feasibility, safety, and effect of autologous bone marrow-derived mesenchymal stem cells~     (MSCs) and c-kit+ cardiac stem cells (CSCs) both alone and in combination (Combo), compared~     to placebo (cell-free Plasmalyte-A medium) as well as each other, administered by~     transendocardial injection in subjects with ischemic cardiomyopathy.~   "
81374|NCT02501798|"~     This study aims at investigating the direct effects of methylphenidate on school performance~     of primary school children. Although behavioral effects of this frequently prescribed drug~     are thoroughly studied (and confirmed), the effects of methylphenidate on school performance~     are less clear. Recent overviews indicate that effects are mainly quantitative and~     subject-specific. To gain more insight in this issue, the current double blind placebo~     controlled crossover study investigates not only the effects of methylphenidate on school~     performance but also it's effect on related variables such as short term memory, motivation~     and behavior. 60 children with ADHD are included and tested twice (with medication and with~     placebo) at their primary school.~   "
81375|NCT02501785|"~     The purpose of this study is to understand the level of caregiver burden related to caring~     for a patient who goes home within the first 24 hours following surgery. As the caregiver~     they are providing care to a family member, friend, or neighbor. Even when not formally~     trained, the care they provide is important to the patient's recovery. Providing care in this~     manner can be stressful. This study will help us understand what aspects of the patient's~     recovery are most difficult for the caregiver.~   "
81376|NCT02501772|"~     For diabetic patient with persisted albuminuria under the intensive control on blood pressure~     and blood glucose, the non-invasive method of acupressure at Sanyinjiao (SP6) is easy to use~     and significantly effect on albuminuria reduction in patients of diabetic nephropathy.~   "
81377|NCT02501759|"~     This pilot clinical trial studies transrectal magnetic resonance imaging (MRI)-guided biopsy~     to see how well it works in identifying cancer in patients with suspected prostate cancer who~     are scheduled to undergo standard biopsy. Transrectal MRI-guided biopsy uses a thin needle~     inserted through the rectum into the prostate and takes a sample of tissue, guided by MRI.~     MRI uses magnets to take pictures of the prostate and may be able to identify cancer.~     Transrectal MRI-guided biopsy may be more accurate and cause patients less pain than standard~     ultrasound-guided biopsy. It is not yet known whether transrectal MRI-guided biopsy is more~     effective than ultrasound-guided biopsy in identifying prostate cancer.~   "
81378|NCT02501746|"~     Specific Aims: Bridging Income Generation with GrouP Integrated Care (BIGPIC) Over 80% of~     cardiovascular disease (CVD) deaths occur in low- and middle-income countries (LMICs).~     Diabetes, a major risk factor for CVD, is also responsible for substantial morbidity and~     mortality in LMICs. Elevated blood pressure (BP) increases CVD risk among individuals with~     diabetes and pre-diabetes; BP control is therefore a powerful way to reduce CVD risk.~     Cost-effective, culturally appropriate, and context-specific approaches are critical. Two~     promising strategies to improve health outcomes are group medical visits and microfinance.~     Both can increase quality of care, clinician-patient trust, self-efficacy, health savings,~     self-confidence, group cohesion, and social support. While these strategies have been~     successful in other contexts, their impact on CVD risk reduction among diabetics and~     pre-diabetics in low-resource settings is not known.~      In partnership with the Government of Kenya, the Academic Model Providing Access to~     Healthcare (AMPATH) Partnership has expanded its clinical scope of work to include diabetes~     and hypertension. AMPATH has piloted group care and microfinance initiatives among patients~     with chronic diseases with promising early results. Both strategies are feasible, as is~     integration of group medical visits into microfinance groups. However, the effectiveness of~     these strategies individually, and in combination, on improving CVD risk is not known.~      Thus, the objective of this proposal is to utilize a transdisciplinary implementation~     research approach to address the challenge of reducing CVD risk in low-resource settings. The~     central hypothesis is: group medical visits integrated into microfinance groups will be~     effective and cost-effective in reducing CVD risk among individuals with diabetes and at~     increased risk for diabetes in western Kenya, and that the key modifiable CVD risk factor to~     be addressed is BP. The research team hypothesize that group medical visits and microfinance~     may each reduce CVD risk, but the integration of group medical visits and microfinance will~     yield the largest gains. Also further hypothesize is that changes in social network~     characteristics may mediate the impact of interventions on the primary outcome, and that~     baseline social network characteristics may moderate the impact of interventions. To test~     these hypotheses and achieve the overall objectives, the following specific aims will be~     pursued:~      Aim 1: Identify the contextual factors, facilitators, and barriers that may impact~     integration of group medical visits and microfinance for CVD risk reduction, using a~     combination of qualitative research methods: 1) baraza (traditional community gathering) form~     of inquiry; and 2) focus group discussions among individuals with diabetes or at increased~     risk for diabetes, microfinance group members, and rural health workers.~      Subsidiary Aim 1.1: Use identified facilitators and barriers to develop a contextually and~     culturally appropriate integrated group medical visit-microfinance model to reduce CVD risk~     among individuals with diabetes or at increased risk of diabetes. This model's acceptability~     and feasibility will be assessed by conducting focus group discussions with patients,~     microfinance group members, and health workers.~      Aim 2: Evaluate the effectiveness of group medical visits and microfinance groups for CVD~     risk reduction among individuals with diabetes or at increased risk for diabetes, by~     conducting a four-arm cluster randomized trial comparing: 1) usual clinical care; 2) usual~     clinical care plus microfinance groups only; 3) group medical visits only (no microfinance);~     and 4) group medical visits integrated into microfinance groups. The primary outcome measure~     will be one-year change in systolic blood pressure (SBP), and a key secondary outcome will be~     change in QRISK2 CVD risk score, which has been validated for Black Africans.~      Subsidiary Aim 2.1: Conduct mediation analysis to evaluate the influence of changes in social~     network characteristics on intermediate factors and intervention outcomes and moderation~     analysis to evaluate the influence of baseline social network characteristics on~     effectiveness of interventions.~      Aim 3: Evaluate the incremental cost-effectiveness of each intervention arm of the trial, in~     terms of costs per unit decrease in SBP, per percent change in CVD risk score, and per~     disability-adjusted life year saved.~      This research project will add to the existing knowledge base on innovative, scalable, and~     sustainable strategies for reducing CVD risk in diabetes and other chronic diseases in LMICs~     and other low-resource settings. If proven to be effective, the investigators are poised to~     expand the approach beyond the trial, thus ensuring that this research will have a~     significant and positive health impact on a larger population.~   "
81379|NCT02501733|"~     This study is to average Forgotten Knee Score (FJS) of those patients receiving the Medacta~     GMK Sphere® knee at the two and five year time points. 70 subjects, enrolled at the data~     coordinating center in Medacta GMK Sphere® vs Posterior Stabilized study (WIRB Pro Num:~     20141994) and randomized to the Sphere arm, will have their data utilized for this study.~   "
81380|NCT02501720|"~     Post burn flexion contractures are common in pediatric age group. Release of contracture and~     coverage with full thickness skin graft (FTSG) is a widely used procedure for this problem.~     This procedure is routinely done under tourniquet control because bloodless operative field~     is essential to visualize important neurovascular structures in hand.~      Use of tumescent technique without a tourniquet is gaining acceptance because it avoids~     complications associated with tourniquet use, maintains a blood less surgical field and~     decreases operative time. Furthermore use of tumescent anesthesia often results in better~     surgical outcomes.~      Although the benefits of tumescent technique used in wide awake hand surgery are well~     documented, epinephrine at a concentration of 1:1 000,00 has also been used as a replacement~     for pneumatic tourniquet for release of hand contracture in infants and adults under general~     anesthesia. Thus epinephrine 1:1,000,00 in saline solution can be a potential replacement for~     a tourniquet in hand surgeries done under general anesthesia.~   "
81381|NCT02501707|"~     Severe radiation-induced lung injury (RILI) occurs in approximately 20% of the lung cancer~     patients, who are treated with curative chemoradiation. In this study the investigators want~     to evaluate the prognostic value of baseline cardiac function assessed with echocardiography~     for prediction of RILI.~   "
81382|NCT02501694|"~     Define responses to exercise on both arterial bruits and oxymetry in patients referred for~     suspected endofibrosis.~   "
81481|NCT02500407|"~     This is a Phase 1/1b dose-escalation study of BTCT4465A (Mosunetuzumab) administered as a~     single agent and in combination with atezolizumab in participants with relapsed or refractory~     B-cell NHL and CLL. The study will consist of a dose-escalation stage and an expansion stage~     where participants will be enrolled into indication-specific cohorts.~   "
82065|NCT02492776|"~     The purpose of this study is to compare the multiple dose pharmacokinetics (PK) of two~     gefapixant (AF-219) formulations; to assess the effect of omeprazole on the multiple dose PK~     of two gefapixant formulations; and, to assess the safety and tolerability of gefapixant.~   "
81383|NCT02501681|"~     Single-centre prospective randomized study will be included the patients who undergo elective~     cardiovascular surgery. Preoperative fluid deficit will be calculated by the formula as~     starvation period X 4 X weight. Patients will be divided into two groups: Group A (n=20);~     crystalloid as priming solution used in patients, Group B (n=20); colloids as priming~     solution used in patients. In addition to priming solutions, extracorporeal pump will be~     filled with 150 mL of Mannitol, 60 mL of NaHCO3 and 10000 IU Insulin. Standard anesthesia~     protocol will be administered to all patients. Ringer's Lactate will be given at first 30~     minute after induction. Ringer's Lactate as fluid maintenance will be administered at a rate~     of 100 mL/h except in extracorporeal circulation. Goal-directed fluid management will be~     performed by PVI (Pleth Variability Index). Cut off level of PVI will be accepted %15.~   "
81384|NCT02501668|"~     The investigators will evaluate the prevalence of lung cancer associated with interstitial~     lung disease (ILD) and idiopathic pulmonary fibrosis (IPF) utilizing the Korean Health~     Insurance Review and Assessment Service (HIRA) database, spanning the period from January~     2011 to December 2011. The database (HIRA-NPS-2011-0001) was based on random sampling of~     outpatients from whole population. Patients with ILDs, IPF, connective tissue disorder (CTD),~     and COPD were identified based on the International Classification of Disease-10 (ICD-10)~     diagnostic codes.~   "
81385|NCT02501655|"~     BACKGROUND: Mesh nebulizers (MN) have lower residual volume and increased inhaled dose~     compared to jet nebulizers (JN) per in vitro and animal models. The aim of this study was to~     compare radioaerosol deposition using MN and JN in healthy subjects, using 2-D planar~     scintigraphy. METHODS: A randomized trial in 6 normal subjects (4 female, 2 male) inhaled~     99mTc-DTPA with an activity of 1 mCi with the normal saline to a total dose of 4 mL with JN~     (Misty Max, Air Life, Yorba Linda, USA) oxygen flow of 8 L / min and 1.5 mL with MN (Aeroneb~     Solo with Ultra adapter; Aerogen Galway, Ireland). Scintigraphy was used to determine~     distribution of deposition and mass balance between compartments.~   "
81386|NCT02501642|"~     The proposed study will address a very important issue for the VA both currently and in the~     future -- the high percentage of OIF/OEF/OND Veterans who have been medically diagnosed with~     a mild traumatic brain injury (mild TBI) and experience distressing symptoms. Smart phone~     mobile applications have become a primary source of information and communication among large~     percentages of Americans, especially those of the OIF/OEF/OND generation. The proposed study~     is a 4-year randomized control trial investigating the utility of an interactive,~     self-management smartphone application, TBI Coach, one of a suite of mobile applications~     developed by VA. The primary goal of the proposed study is to evaluate the efficacy of TBI~     Coach for improving clinical outcomes in those with a history of mild TBI and to determine~     what aspects of TBI Coach are most useful to Veterans. An overarching goal of this line of~     research is to improve access among Veterans with mild TBI who still have symptoms months to~     years after injury.~      Objectives. The study will pursue the following objectives:~        1. Evaluate the efficacy of TBI coach for improving clinical outcomes among recipients of~          TBI Coach.~        2. Determine the aspects of TBI Coach most associated with positive outcomes.~        3. Obtain qualitative information on factors associated with use of TBI coach or with~          deriving benefit from use of TBI Coach that can be used to inform future modifications~          of the application and wide scale implementation.~   "
81387|NCT02501629|"~     The primary objective of the study is to determine the ability of reslizumab administered sc~     to produce a corticosteroid-sparing effect in patients with oral corticosteroid~     (OCS)-dependent asthma and elevated blood eosinophils, without loss of asthma control.~   "
81388|NCT02501616|"~     This is a phase 4, single center, randomized, open-labeled, cross-over design study. The~     primary objective of the study is to compare effect of dapagliflozine and metformin on~     endothelial function.~      Subjects are randomized to initial metformin or initial dapagliflozin group and maintained~     initial treatment for 8 weeks. During that period, dose of dapagliflozin is maintained~     10mg/day and metformin can be titrated upto 2000 mg/day. After 1 weeks of washout period, 8~     weeks' cross-over is followed.~   "
81389|NCT02501603|"~     For the gastric cancer, paclitaxel is recommended as salvage standard treatment. Afatinib is~     a novel, potent, small ErbB family blocker that covalently binds and irreversibly blocks~     signaling through activated EGFR, HER2 and ErbB4 receptors, as well as the~     transphosphorylation of ErbB3. The investigators suggest a randomized phase II trial of~     afatinib plus weekly taxol(paclitaxel) for previously treated EGFR positive gastric cancer~     patients. The aim of current trial is to evaluate the antitumor efficacy of afatinib for~     target enriched patients in gastric cancer.~   "
81390|NCT02501590|"~     Drawing on a vertical surface, such as a blackboard (rather than a horizontal surface) is~     often used by occupational therapists as a way of developing fine motor control and visual~     motor integration in children. While there is anecdotal evidence to support this~     intervention, preliminary results in healthy children showed no differences in graphical~     quality while drawing on vertical or horizontal surfaces. This however was not investigated~     in children with graphomotor impairments.~      The goal of this study is to determine whether movements produced on a vertical surface~     differ in their performance level and muscle activation patterns compared to movements~     produced on a horizontal surface. The investigators predict that the level of performance on~     the vertical surface will exceed the level of performance on the horizontal surface.~     Additionally, the investigators hypothesize that the proximal muscles will be more activated~     and fatigued (in longer tasks) while drawing on the vertical surface, while the distal muscle~     will be more activated and fatigued while drawing on the horizontal surface.~   "
81391|NCT02501577|"~     Placement of a supraglottic airway device Fiberoptical verification of pharyngeal position~   "
81392|NCT02501564|"~     Osteoarthritis (OA) pain treatment has limitations in terms of serious adverse effects and~     low efficacy. The investigators aimed to evaluate efficacy and safety of naproxen~     sodium/codeine phosphate combination in these patients.~   "
81393|NCT02501551|"~     This is a phase II trial of regorafenib in patients with metastatic melanoma harboring c-Kit~     mutations and/or amplifications of c-Kit gene copy number. The primary end point is disease~     control rate (DCR), and the secondary end points are safety, response rate (RR), progression~     free survival (PFS), and overall survival (OS).~   "
81506|NCT02500082|"~     The purpose of this study is to determine whether triheptanoin (UX007) is effective in the~     treatment of neurological symptoms related to citrate transporter deficiency (SLC13A5 gene~     mutation).~   "
81394|NCT02501538|"~     This is a pilot study. The investigators plan a cohort study of 10 patients with a diabetic~     foot ulcer (DFU). Study duration will be three weeks. Patients will be consented and undergo~     debridement as standard of care at day 0. Ankle-Brachial Index (ABI), Monofilament Sensory~     Test and Vibration Perception Threshold(VPT) test will be performed only at day 0. Tissue~     samples will be taken at this visit during standard of care wound debridement and these~     tissue samples of the wound would normally be removed as part of routine debridement. These~     tissue samples of the wound will be used for gene expression and bacterial~     analysis(research). The patient will then receive topical oxygen therapy using the TransCu O2~     device (research) with moist wound dressings for 21 days. Moist wound dressings are used as~     standard of care. Treatment will be initiated during Screening/Baseline visit(day 0) after~     routine wound debridement, and patient will receive instructions for home use of the device.~     The patient will be seen for routine wound debridement at days 7, 14, and 21 with a study~     window of 5 days., Digital photos of the wound, acetate tracing of the wound and vascular~     evaluations(SensiLase, Transcutaneous oxygen measurements, Hyperspectral imaging) will be~     performed at each study visit(research).Tissue samples will be taken during standard of care~     wound debridement at every study visit. Results of the data analysis from this project will~     be used to inform the design of a larger randomized clinical trial.~   "
81395|NCT02501525|"~     This study will include patients aged between 18 and 70 who will undergo retrograde~     intrarenal surgery (RIRS) due to renal stone(s). A total of 80 patients (male or female) will~     be recruited, and will be randomized into 2 groups consisting of 40 patients in each group.~     The first group of patients will undergo RIRS with a ureteral access sheath (UAS) positioned~     prior to surgery; and the second group will undergo RIRS without UAS. As use of UAS decreases~     the pressure in the renal pelvis during RIRS, it is aimed to evaluate whether using UAS or~     not affects the level of pain felt by patients in the postoperative period.~   "
81396|NCT02501512|"~     This study aims to extract and discriminate the signals of respiration, heart rate and~     swallowing from a standard ECG and EMG signal obtained using a special neonatal gastric tube.~     These signals will be compared with the standard monitoring signals in the neonatal intensive~     care unit (NICU). Further, they will be used to search for objectively quantifiable~     maturational coordination processes of respiration, heart rate and swallowing. Lastly, this~     study aims to identify changes in ECG/EMG-signals as a result of external stimuli (e.g.~     nursing interventions) in the NICU.~   "
81397|NCT02501499|"~     This is an exploratory, qualitative evaluation study of the Breastfeeding Buddies (BFB)~     program. The Breastfeeding Buddies Program is a peer-based education and support program~     offered through the Kitchener Downtown Community Health Centre. The KDCHC has received~     funding to undertake a qualitative exploratory study of the BFB program. KDCHC has partnered~     with researchers at the Manulife Centre for Community Health Research at Wilfrid Laurier~     University to plan and implement this study.~      The purpose of the evaluation study is to understand the perspectives and experiences of~     Breastfeeding Buddies (BFB) participants and volunteers. The evaluation will explore the~     process of implementation of the BFB education and support programs and assess the program~     impacts from the perspective of participants and volunteers. The methods in this study are~     qualitative because the BFB program has never collected qualitative data from program~     participants and volunteers. In the past, evaluation of the program has been limited to pre~     and post surveys. This qualitative study includes two components:~        1. Interviews 6-8 weeks after the participants due dates with consenting mothers who~          participated in the Me Breastfeed workshop - 10-12 mothers who were matched with a Buddy~          (optional for all workshop participants) will be interviewed and 10-12 mothers who did~          not seek a match (but did participate in the workshop) will be interviewed to explore~          what they learned, what was helpful and how the program can be improved.~        2. One focus group with 10-15 Breastfeeding Buddies volunteers to explore the experiences~          and perspectives of the BFB volunteers.~   "
81398|NCT02501486|"~     Rationale: Case reports describe suppression of the hypothalamic-pituitary-adrenal (HPA) axis~     caused by local corticosteroids, most often with inhalation corticosteroids. The exact~     prevalence is not known. Early recognition is important, because suppression of the HPA-axis~     can lead to significant morbidity and mortality. Suppression of the HPA axis might occur more~     often when a Cytochrome P450 3A4 (CYP3A4) inhibitor, e.g. ritonavir, is used next to the~     local corticosteroid, a combination often used by human immunodeficiency virus~     (HIV)-patients. Cortisol can be determined in hair. This non-invasive analysis could help in~     diagnosis of suppressed HPA-axis.~      Research questions:~      Primary objective:~        1. How often do inhalation or nasal corticosteroids lead to suppression of the HPA- axis in~          HIV-treated patients?~           Secondary objectives:~        2. Are other variables associated with the HPA-axis suppression?~        3. Are cortisol measurements in hair as reliable as serum cortisol or an~          Adrenocorticotropic hormone (ACTH) stimulation test to diagnose suppression of the HPA~          axis? Study design: cross-sectional explorative study Study population: adults treated~          for HIV and using an inhalation or nasal corticosteroid.~      Intervention: an ACTH stimulation test, cortisol measurements in blood and hair.~      Main study parameters/endpoints:~      Proportions of persons with a low morning plasma cortisol or low cortisol after an ACTH~     stimulation test. Correlation between cortisol in plasma and hair cortisol.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: Each person will be screened with a history and a short physical examination. A~     venous cannula will be inserted for obtaining blood for the plasma cortisol and for the ACTH~     stimulation test. An ACTH stimulation test has no major complications. A piece of hair is cut~     for cortisol hair analysis. The risks and burden are minimal, while the future benefits could~     be great since suppression of the endogenous HPA- axis can be associated with morbidities~     like hypertension or osteoporosis and can even lead to an adrenal crisis when the local~     corticosteroid is stopped.~   "
81399|NCT02501473|"~     This is a Phase 1/2 open label trial of G100 in patients with low grade NHL. G100 is composed~     of glucopranosyl lipid A in a stable emulsion and is a potent TLR4 (toll-like receptor-4)~     agonist. G100 will be administered by direct injection (intratumorally) into tumors of low~     grade NHL following standard low dose radiation therapy. Preclinical models and clinical~     studies in other cancers such as Merkel cell carcinoma have demonstrated that G100~     administered in this manner can alter the tumor microenvironment, activate dendritic cells, T~     cells and other immune cells and induce systemic anti-tumor immune responses. In this trial,~     the safety, immunogenicity, and clinical efficacy of G100 will be examined alone or with~     pembrolizumab.~   "
81419|NCT02501213|"~     While some authors recommend diuretics as the first treatment to initiate for symptoms caused~     by malignant ascites (MA), their prescription is variable. No randomized, controlled study~     has assessed their benefit in this context. According to literature, diuretics may bring~     relief in about 40% of cases, regardless of primary tumor.~      The purpose of our study is to assess the effectiveness of diuretic treatment according to~     Serum Ascites Albumin Gradient (SAAG) measured before treatment. Judgment criteria is the~     time elapsed between recurrent MA that requires paracentesis. The investigators will also~     examine whether SAAG and serum levels of renin and aldosterone can predict symptom response~     to diuretics.~   "
81400|NCT02501460|"~     This study is being conducted because low lean muscle mass is prevalent among childhood~     cancer survivors. Lean muscle is the non-fatty muscle tissue that makes up part of the body's~     lean body mass. Low lean muscle mass is associated with loss of overall body strength,~     declining mobility and eventually, loss of independence. Among childhood cancer survivors,~     low lean muscle mass may contribute to reduced physical functioning and a sense of fatigue~     with exertion, limiting ability to participate in adequate physical activity. Loss of~     strength and a sense of fatigue with repeated movement make it difficult to participate in~     daily activities.~      Although there have not been exercise intervention studies among childhood cancer survivors~     specifically designed to evaluate the effects of resistance training on muscle mass, studies~     among individuals with chronic disease, including survivors of adult onset cancers, indicate~     that resistance exercise improves muscle mass, muscle strength, mobility, vitality and~     physical activity levels. Resistance training (weight lifting) is a form of physical activity~     that is designed to improve muscular fitness by exercising a muscle or a muscle group against~     external resistance.~      The purpose of the study is to evaluate the effects of resistance training combined with~     either a protein supplement or a sports drink on changes in lean muscle mass in young adults~     who were treated for childhood cancer. The sports drink, for this study, is considered a~     placebo.~   "
81401|NCT02501447|"~     Stress is known to trigger acute pain crisis of sickle cell disease (SCD). SCD is an~     inherited blood disorder that afflicts about 100,000 people in the United States, and is~     among the most common lethal genetic diseases in the United States. Though worldwide in~     distribution, in the US it is most commonly found in African Americans. Its best known~     complication is severe, recurrent relentless pain, often known as pain crisis. Non-drug~     treatment for SCD pain such as cognitive coping interventions have been shown to be effective~     for reducing SCD pain intensity, but they are complicated, multifaceted, and time-consuming.~     A simple and cost-effective alternative such as guided imagery (GI) could reduce the effect~     of stress on SCD pain. GI is an intervention where patients listen to and view audio-visual~     recordings while being directed to visualize themselves being immersed in that scene or~     scenario. There are no published studies on the use of GI as a simple stress coping~     intervention or tracking stress in a systematic manner as a trigger for SCD pain.~   "
81402|NCT02501434|"~     A Blind-adjudication Multi-center Phase II Randomized Clinical Trial of Continuous Low-dose~     Intravenous Heparin Therapy in Coiled Low-grade Aneurysmal Subarachnoid Hemorrhage Patients~     with Significant Hemorrhage Burden.~   "
81403|NCT02501421|"~     The study is a single centre, phase I, double-blind, randomized, placebo-controlled trial~     that explored the safety and immunogenicity of 2 doses (Day 1 and Day 21) TB/FLU-04L~     tuberculosis vaccine versus matched placebo in BCG-vaccinated healthy adult subjects aged~     18-50 years.~   "
81404|NCT02501408|"~     Evaluate a new porosthetic device in lower limb amputees.~   "
81405|NCT02501395|"~     Kennedy disease is an inherited neuromuscular disorder that is characterized by progressive~     muscle wasting and weakness. It typically starts with muscle spasms and tremors in the arms,~     followed by muscle weakness and atrophy of muscles in the arms and legs. The facial and~     bulbar muscles are also involved. However, the muscle involvement pattern has not been~     investigated systemically in Kennedy disease.~      The primary aim of the study is to investigate the muscle involvement in patients with~     Kennedy disease using MRI. Secondary aims are to examine disease severity and to test MRI as~     a potential outcome measure for future clinical trials in Kennedy disease.~      Approximately 40 patients with Kennedy disease and 20 gender and age matched healthy~     voluntary controls will be recruited. The study consists of one visit per subject lasting 4-5~     hours.~   "
81406|NCT02501382|"~     The purpose of this study is to investigate the effects of hyperic oxygen treatment on the~     immune response in patients with necrotizing soft tissue infections~   "
81407|NCT02501369|"~     Cystic fibrosis (CF) is an illness that makes the lungs clog up with sticky mucus. There is~     no cure and so treatments are used to help make the illness easier to live with. The~     treatment can take lots of time and can feel not very nice sometimes. When children with CF~     become teenagers they need to learn to take charge of their treatment. This can be difficult.~     Teenagers with CF want to fit in with friends and can become more upset about their illness.~     Their parents have to learn to let their child take charge of their illness which can be hard~     for parents. These issues can put strain on parent-child relationships and this can make it~     harder for teenagers to stick to their treatment plans. A parenting program (called Teen~     Triple P) has been shown to help teenagers with other illnesses (such as diabetes) to be able~     to stick to their treatment plans. Parents are given a booklet to work through at home which~     helps them to build on the skills they already have. It aims to help families to support~     positive parent-child relationships, to manage difficult teenage behaviours, and to teach new~     skills and behaviours. So far no one has done any research to see if this program helps~     families of teenagers with CF. This research would like to see if the Triple P program can~     help teenagers with CF stick to their treatment plan. Helping teenagers stick to their~     treatment plan will help them to live happier and healthier lives.~   "
81408|NCT02501356|"~     To compare the effects of daily intake of the ISOThrive supplement vs. a placebo on the~     primary outcome measure of body weight and secondary outcome measures (hunger/satiety,~     health-related measures and self-reported quality of life) in a group of overweight but~     otherwise healthy adults.~   "
81409|NCT02501343|"~     The purpose of this study is to test the effect of increasing the body pH acutely with an~     alkaline medication (sodium bicarbonate, NaHCO3, sodibic) on glucose metabolism post meal in~     non diabetic subjects with normal renal function.~      The investigators aim to determine whether there is an acute reduction in venous blood pH~     following a typical Western-style (high acid load) breakfast in healthy men and women, and~     whether this effect is attenuated by the concurrent administration of an alkaline medication.~     The effect on glucose metabolism, hunger/satiety and arterial stiffness post meal will be~     assessed.~   "
81410|NCT02501330|"~     The objective of this surveillance is to collect information about~        1. adverse drug reaction not expected from the LPD (unknown adverse drug reaction)~        2. the incidence of adverse drug reactions in this surveillance~        3. factors considered to affect the safety and/or efficacy of this drug.~   "
81420|NCT02501200|"~     A randomized, open-label, 2-way crossover study to compare the pharmacokinetics and safety~     CKD-391 to coadministration Atorvastatin and Ezetimibe in health volunteers.~   "
81411|NCT02501317|"~     Introduction: Urinary incontinence is a condition that affects most women in her adult life;~     it is considered a public health problem and has a high negative impact on the quality of~     life. Physical therapy is considered as the first treatment option for this disease, these~     treatments are done with pelvic floor muscles exercises (kinesiotherapy) with or without the~     use of other resources such as biofeedback, electrical stimulation and vaginal cones.~     Rationale: The protocols used in the various studies on the treatment of urinary incontinence~     are made with only one type of therapy and have no change in the intensity of the exercises.~     The Active Perineal Rehabilitation protocol uses kinesiotherapy with biofeedback,~     electrical stimulation, vaginal cones and home exercises; it consists of 14 individual~     sessions that gradually evolve the intensity of exercises. Objective: To assess the~     scientific validity of Active Perineal Rehabilitation protocol for the treatment of urinary~     incontinence. Methodology: A multicenter, prospective clinical trial, controlled and~     randomized, the sample will be divided into a study group that will be treated with the~     Active Perineal Rehabilitation protocol, and a control group will be treated with the~     protocol already widely used.~      Keys Words: urinary incontinence, physical therapy, rehabilitation, pelvic floor, perineum,~     conservative treatment~   "
81412|NCT02501304|"~     This is a prospective, multi-center, single arm, feasibility study to evaluate the safety and~     effectiveness of the ReVENT Sleep Apnea System for the treatment of Obstructive Sleep Apnea.~   "
81413|NCT02501291|"~     Crohn's disease (CD) is a chronic gastrointestinal inflammatory disease characterized by~     relapse and progression. The incidence and prevalence of IBD are increasing in different~     regions around the world, indicating its emergence as a global disease. Though modern medical~     therapies including immunomodulators and biologic agents have revolutionized treatment of CD,~     the occurrence of steroids-dependence and resistance or intolerance to medical therapy is~     quite common. The limitation of present therapeutic management and the high expense of~     biologic agents leads to the treatment of CD become refractoriness. The occurrence rate of~     steroids-dependence and resistance or intolerance to thiopurine therapy is quite high during~     the course of CD. Approximately 38% of cases required surgery within 10 years. Therefore, the~     management of such refractory CD remains a great therapeutic challenge for clinicians.~      Thalidomide is an oral agent that has immunomodulatory, antiangiogenic and TNF(tumor necrosis~     factor)-a- suppressing effects. The potential role for thalidomide in the treatment of~     refractory paediatric and adult CD has been investigated in more and more small open-label~     studies and retrospective case series. Recently, a randomized controlled trial showed~     thalidomide improved clinical remission at 8 weeks of treatment and longer-term maintenance~     of remission in pediatric refractory CD. Gerich et al reported in a retrospective study that~     thalidomide improved long-term outcomes among 37 refractory CD adults followed up for a~     median of 58 months. However, the dose of thalidomide used in these studies ranged from~     50mg/d to 150mg/d, and the occurrence rate of side effects reported variously but all quite~     high. The side effects related to the dose of thalidomide were the major concerns of using it~     in CD. Moreover, the effect of thalidomide on endoscopic response including mucosal healing~     which is a more objective and important outcome in CD was rarely reported. Therefore the aim~     of this study is to investigate the efficacy on clinical and endoscopic response and the~     adverse effects of using low-dose thalidomide in active adult CD patients.~   "
81414|NCT02501278|"~     The aim of this study is to assess the potential benefit of the addition of immunotherapy~     with VGX-3100 and INO-9012 (i.e. INO-3112) to concomitant CRT or, to concomitant CRT and~     continued as adjuvant in patients with locally advanced cervical cancer.~      Safety run-in: To test the safety of CRT combined with immunotherapy with INO-3112. This~     safety run-in phase will include the first 3 patients treated in each of the two INO-3112~     combination arms who are exposed to at least two immunotherapy doses and evaluate whether the~     combination does not pose undue immediate risks to the patients further enrolled in the~     trial.~      Phase II:To demonstrate sufficient activity in the experimental combination arms to warrant a~     further phase III conclusive trial based on progression free survival (PFS) at 18 months~     assessed by RECIST by the local investigator. The efficacy will be assessed within each~     experimental arm while the standard arm will serve as a reference arm to check the~     reliability of the results.~   "
81415|NCT02501265|"~     The purpose of this study is to assess an adaptive approach to smoking cessation~     pharmacotherapy. The protocol is designed to compare adaptive vs. standard approaches to two~     common smoking cessation pharmacotherapies - Varenicline (commonly known as Chantix) and the~     Nicotine Patch. The investigators hypothesize that participants allocated to adaptive therapy~     will show significantly higher biochemically confirmed 30-day continuous abstinence at 12~     weeks post-Target Quit Day (TQD).~   "
81416|NCT02501252|"~     Rationale: Every year, 287,00 million women, and 3.1 million neonates continue to die, and~     the majority of these deaths have been identified as being avoidable. A proxy indicator of~     Millennium Development Goal (MDG) 5, birth with skilled attendance is low in Sub-Saharan~     Africa(47%) and the lowest (13%) is for Ethiopia, with the greatest number of maternal~     deaths. The Ethiopia health system has established a vast network of health infrastructure~     that extends to rural areas with the establishment of over 15,000 health posts and deployment~     of over 30,000 health extension workers throughout the country. Although these unprecedented~     situations made health services more accessible than ever, it is yet to be exploited for~     improving rural women's access to clean and safe delivery and postpartum care. Lack of usage~     of delivery care in the country is related not only to accessibility but also acceptability~     of the services. In fact, the vast majority of women with home deliveries saw institutional~     delivery as unnecessary and a non-customary practice. Therefore, instituting an~     innovative, culturally sensitive, and practically amenable strategy, deployment of CORNs for~     example might be the best remedy, in this case.~      Objective: To evaluate the effectiveness and acceptability of availing Home based Skilled~     Birth Attendance (SBA) Services through Community Reproductive Health Nurses (CORN) in rural~     communities of Ethiopia.~      Study design: Cluster Randomized Controlled Community Trial that will be conducted in four~     phases.~      Study population: Study participants will be all pregnant women who will give birth at home~     and health facility (including health post) during the study period.~      Intervention: The study will be conducted in four phases as discussed below. During the first~     (preparatory) phase, sensitization of relevant stakeholders and recruitment of trainees will~     be conducted. In the second phase, formative and baseline assessment as well as training of~     CORNs will take place. In the third phase, which will be actual intervention phase,~     deployment of CORNs in their respective study site will be done and in the final phase, final~     evaluation and dissemination of study findings will be done. The intension behind deploying~     CORNs to the grassroots level is just to give a backup skilled delivery and other MNH~     services to poor rural mothers who have difficult of accessing modern health facilities for~     various reasons; it has no any intention to promote or encourage home deliveries or replace~     institutional deliveries. Perhaps it will help to assimilate rural mothers to modern health~     facilities Main study parameters/endpoints: The main study end point is percentage of skilled~     birth attendance which is very low in local and national level. In addition secondary study~     parameters are percentage changes of maternal & related services uptakes. These include~     focused Antenatal; care (ANC), long term family planning, Prevention of Mother to Child~     Transmission of HIV (PMTCT) and postnatal care.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: the burden and risks associated with participation to the study is very minimal.~     To mention few; physical examinations (Leopold manoeuvre) or the routine investigations of~     pregnancy this will be anonymous except for the CORNs keeping the principles of shared~     confidentiality in mind. Similarly all questionnaires or medical charts will be kept~     confidential. All CORNs will obtain intensive training on ethical principles that will help~     to minimize any physical and physiological discomfort associated with participation, the~     risks associated with the investigation treatment.~      The study period and Budget: the study will be carried out in a total of 18 months which~     holds a period from the development of protocol to the terminal evaluation and submission of~     reports. The overall study budget will be 99, 987.95 USD (Ninety nine thousands, nine hundred~     eighty seven dollars and ninety five cents~   "
81417|NCT02501239|"~     The primary aim of this project is to conduct a randomized controlled pilot study evaluating~     the feasibility and potential effectiveness of a newly developed combined Health At Every~     Size and Acceptance and Commitment Therapy (HAES/ACT) treatment, known as Accept Yourself!~     compared to a commercial behavioral weight loss program, Weight Watchers (WW). Obese women~     (BMI ≥ 30) with Major Depressive Disorder will be randomly assigned to one of these two~     treatments. Depression, physical health, and other psychosocial outcomes will be assessed~     prior to treatment, at post-treatment, and at 3, 6, 9, and 12-month follow up assessments.~   "
81418|NCT02501226|"~     Background. Major Depressive Disorder (MDD) is highly prevalent and was associated with~     greater morbidity, mortality (including suicide), and healthcare costs. By 2030, MDD will~     become the leading cause of disability in high-income countries. Notably, among patients with~     a previous experience of a major depressive episode, it was indeed estimated that up to 85%~     of those patients will suffer from relapse. Two main factors were associated with a~     significantly higher risk of relapse: poor medication adherence and low self-efficacy in~     disease management. Interestingly, these issues could become the targets of psychoeducational~     programs for chronic diseases. Inded psychoeducational program for depression are recommended~     in international guidelines, but have not yet been proposed in France.~      Methods/Design: The investigators propose to evaluate the first French psychoeducational~     program for depression named ENVIE in a multicenter randomized controlled trial. Its aim is~     to educate patients on the latest knowledge on depression and effective treatments through~     didactic and interactive sessions. Patients will experiment the latest innovating~     psychological skills (from acceptance and commitment therapy) to cope with depressive~     symptoms and maintain motivation in behavioral activation. In total, 332 unipolar non-chronic~     (< 2 years) outpatients with moderate to severe depression, without psychotic features, will~     be randomly allocated to the add-on ENVIE program (N=166) or to a waiting list (N=166). The~     follow-up will last 15 months and include 5 assessment visits (enrollment, 3, 6, 9, 12, 15~     months).~      Discussion. If the proposed trial shows the effectiveness of the intervention, but also an~     increased remission rate in depressed outpatients at 15-months post-inclusion, in addition to~     improved treatment adherence in patients, it will further promotes arguments in favor of a~     wide dissemination of psychoeducational programs for depression.~   "
81421|NCT02501187|"~     Blepharoptosis, inferodisplacement of the upper eyelid, can be congenital or acquired.~     Acquired Blepharoptosis is usually aponeurotic, due to stretching or disinsertion of the~     levator aponeurosis. Treatment is surgical and can be performed by three common procedures -~     Levator advancement, Müller's muscle-conjunctival resection procedure and White line~     advancement. A number of reports inspected the possibility that Blepharoptosis repair~     procedures may cause deterioration in dry eye status. The investigators would like to assess~     whether there is a difference between the different procedures in their influence on dry eye~     status.~   "
81422|NCT02501174|"~     The aim of this study is to establish a common geriatric oncology medical database. The~     patients concerned are the patients having benefited from a geriatric oncology consultation~     in one of the participating centres. This database is designed with a view on the one hand to~     better describe to better understand this population and on the other hand to facilitate the~     conduct of future retrospective or prospective studies on this population. The constitution~     of this observatory of patients seen in consultation should facilitate the development of~     studies from the analysis of data collected, and occasional surveys by the rapid~     identification of cases. Data from this database could provide clinicians with valuable~     informative elements of descriptive epidemiology and concerning the organization of care in~     the geriatric oncology field.~   "
81423|NCT02501161|"~     This trial is conducted in Africa, Asia, Europe, North America and South America. The purpose~     is to compare long-term glycaemic control of insulin degludec/liraglutide (IDegLira) versus~     insulin glargine (IGlar) in insulin naïve subjects with type 2 diabetes mellitus inadequately~     controlled with oral anti diabetics.~   "
81424|NCT02501148|"~     The purpose of this study is to assess the safety and clinical performance of Paladin System~     in patients with carotid artery stenosis.~   "
81425|NCT02501135|"~     The purpose of this study is to retrospectively compare perioperative pain relief and safety~     in pediatric patients who have received a femoral nerve block with varying concentrations of~     local anesthetic.~   "
81426|NCT02501122|"~     The purpose of this study is to interrogate the Partners for Kids (PFK) and the pediatric~     health information (PHIS) databases in addition to our own perioperative Nationwide~     Children's data base to look at outcomes, resource utilization, and cost trends for~     adenotonsillectomy in the nationally versus locally. The investigators also want compare~     Nationwide Children's to other regional and national tertiary pediatric institutions.~   "
81427|NCT02501109|"~     The purpose of this study is to compare the rate and extent of absorption of Aripiprazole~     Oral Soluble Film 10 mg (Test) versus Abilify® 10 mg tablet (Reference) in healthy male~     volunteers~   "
81428|NCT02501096|"~     This is an open-label Phase 1b/2 trial of lenvatinib (E7080) plus pembrolizumab in~     participants with selected solid tumors. Phase 1b will determine and confirm the maximum~     tolerated dose (MTD) for lenvatinib in combination with 200 milligrams (mg) (intravenous~     [IV], every 3 weeks [Q3W]) pembrolizumab in participants with selected solid tumors (i.e.~     non-small cell lung cancer, renal cell carcinoma, endometrial carcinoma, urothelial~     carcinoma, squamous cell carcinoma of the head and neck, or melanoma). Phase 2 (Expansion)~     will evaluate the safety and efficacy of the combination in 6 cohorts at the MTD from Phase~     1b (lenvatinib 20 mg/day orally + pembrolizumab 200 mg Q3W, IV).~   "
81429|NCT02501083|"~     Muscular dystrophies are inherited disorders that affect skeletal muscle. Cardiac and~     respiratory function may be affected in this group of diseases. The investigators sought to~     analyze the long term cardiac and respiratory function in patients with muscular dystrophies~     recquiring home mechnaical ventilation .~   "
81430|NCT02501070|"~     This is a multicenter retrospective observational study with STEMI (ST Elevation Myocardial~     Infarction) patients who have been treated in the northern Galician Hospitals. The study~     tries to verify if the implantation of the PROGALIAM (Galician Assistance Program Acute~     Myocardial Infarction) has supposed a progress in the quality and expectancy of life of AMI~     patients in the north area of Galicia.~      The study will recruit STEMI patients according to the third consensus definition of~     myocardial infarction type I.~      It will include all patients who meet these criteria regardless of other demographic or~     clinical circumstances. There is not exclusion criteria defined for this population.~   "
81431|NCT02501057|"~     The purpose of this study is to compare the effects of interventions for drinking-reduction~     and antiretroviral therapy (ART) adherence among HIV-positive primary care patients. The~     interventions consist of brief meetings to discuss drinking and ART adherence enhanced with~     daily self-monitoring through the use of a smart phone application that tracks drinking and~     other aspects of health. These meetings will either be based on the Clinician's Guide, a~     brief intervention for heavy drinking in primary care settings advocated by the National~     Institute on Alcohol Abuse and Alcoholism, or Motivational Interviewing. Participants will be~     assessed at baseline, 30, 60, 90 days, 6 and 12 months after baseline. By the end of~     treatment (60 days) and throughout the follow-up period, alcohol use is expected to highest~     among participants who receive the Clinician's Guide alone, intermediate among participants~     who receive the enhanced Clinician's Guide, and lowest among participants who receive~     enhanced Motivational Interviewing.~   "
81432|NCT02501044|"~     Hemodialysis patients may experience drops in blood oxygen saturation during the hemodialysis~     treatment, which may lead to hypoxia in the tissues.~      The investigators hypothesize that:~        1. The cumulative number, severity, or other characteristics of such deoxygenation episodes~          may be a predictor of adverse outcomes in hemodialysis patients.~        2. There may be demographic, anthropometric, clinical, treatment prescription, lab~          analytical, and other parameters that correlate with the number and severity of~          deoxygenation episodes and, therefore, may be used for risk stratification. Further,~          some of these parameters may be modifiable.~   "
81433|NCT02501031|"~     The purpose of this study is to understand whether consuming flaxseed for approximately 50~     days may beneficially affect the level of certain hormones in the blood thought to be~     involved in the development of breast cancer. This study will address the first steps toward~     the development of possible breast cancer prevention strategies. Differences in hormone~     levels (from blood samples) will be compared between two groups of women - those in the group~     assigned to eating ground flaxseed daily and those in the control group (with no change in~     diet).~   "
81434|NCT02501018|"~     A prospective, open label, controlled, randomized, double arm, multi-center study to assess~     the efficacy and safety of CLBS12 in patients with critical limb ischemia (CLI) due to~     arteriosclerosis obliterans (ASO) with a single arm sub-study to assess the safety and~     potential efficacy of CLBS12 in patients with CLI due to Buerger's Disease (BD).~   "
81435|NCT02501005|"~     The BERLIN VT study is designed to evaluate the impact of prophylactic ventricular~     tachycardia (VT) ablation on all-cause mortality and unplanned hospital admission for~     congestive heart failure or symptomatic ventricular tachycardia/ventricular fibrillation (VF)~     when compared to VT ablation after the third appropriate implantable~     cardioverter-defibrillator (ICD) shock.~   "
81436|NCT02500992|"~     Transrectal Hybrid natural orifice translumenal endoscopic surgery sigmoidectomy has gained~     popularity. It is an appealing technique as a minilaparotomy in order to retrieve the~     specimen is avoided. Therefore less postoperative pain and a better cosmetic result are~     expected. The feasibility of the technique has been demonstrated.~      Still an open question is the risk of intraperitoneal contamination as in this procedure the~     colon has to be opened. This is the case for (a) retrieval of the specimen thru the opened~     rectal stump and (b) for intracorporeal insertion of the anvil of the circular stapler in~     order to fashion an anastomosis.~      In this study the bacterial contamination in the rectal stump as well as in the peritoneal~     cavity is assessed. The results are compared to bacteriological samples taken in a comparison~     group consisting of conventional laparoscopic assisted sigmoidectomies.~   "
81437|NCT02500979|"~     This study is designed to investigate the clinical efficacy and safety of pramlintide~     co-administered as a fixed-dose ratio with basal-bolus SC insulin, delivered simultaneously~     via 2 separate pumps, in subjects with type 1 diabetes who are failing to achieve the desired~     level of glycemic control using insulin therapy.~   "
81438|NCT02500966|"~     Cervical stenosis may occur in up to 19% after conization. It is a cause of infertility and~     amenorrhea. This study will test a new device named DUDA Device (Dispositivo Uterino para~     dilatar canal endocervical) placed just after the conization, in order to evaluate the~     safety, efficacy and quality of life.~   "
81439|NCT02500953|"~     The objectives of this study are to evaluate the safety and tolerability of a single and~     multiple oral dose of ASP3325 and to evaluate the effect of administration timing on the~     pharmacodynamics of ASP3325 orally administered three times a day.~   "
81440|NCT02500940|"~     The purpose of this study is to investigate the impact of different neoadjuvant chemotherapy~     schedules of cisplatin and 5-FU on acute toxicity, tumor response, and long-term survival in~     patients with advanced nasopharyngeal carcinoma~   "
81441|NCT02500927|"~     The purpose of this study is to determine the safety, the antitumor activity and the~     pharmacokinetics of ASP8273 in EGFR tyrosine kinase inhibitor (EGFR-TKI)-naïve patients with~     non-small cell lung cancer (NSCLC) harboring EGFR activating mutations.~   "
81442|NCT02500914|"~     This is a Phase 1a/1b study of SC-002 in patients with relapsed small cell lung cancer (SCLC)~     or large cell neuroendocrine carcinoma (LCNEC). SC-002 is an antibody-drug conjugate (ADC)~     comprised of a monoclonal antibody linked to a potent chemotherapy.~      The purpose of this study is to assess the safety and tolerability of SC-002 at different~     dose levels, to determine the highest dose of SC-002 that can be given to patients with SCLC~     or LCNEC, to evaluate the side effects of SC-002, and to assess the anti-cancer activity of~     SC-002.~   "
81443|NCT02500901|"~     This is a phase I study to determine the safety and feasibility of the combination of~     enzalutamide and niraparib in subjects with metastatic castration-resistant prostate cancer~     (CRPC).~   "
81444|NCT02500888|"~     The aim of this study is to evaluate, through a pilot study with about ten cases, if~     bilateral ventral capsulotomy by linear accelerator enable modification of~     obsessive-compulsive symptoms and quality of life in patients with severe and refractory~     obsessive compulsive disorder (OCD) and also investigate possible adverse effects /~     complications of the procedure.~   "
81445|NCT02500875|"~     The objective of this study is to evaluate the effectiveness of PTNi therapy versus PTN~     therapy without instillation in the treatment of infected surgical wounds. Investigators mean~     to verify differences of effectiveness between the different types of instilled substances,~     normal saline versus Amukine Med 0.5%.~   "
81446|NCT02500862|"~     Characterize potential biomarkers of sight-threatening eye diseases based on the information~     acquired in clinical practice at CEC, AIBILI~   "
81447|NCT02500849|"~     The purpose of the study is to evaluate the safety and feasibility of administering~     SB-728mR-HSPC after conditioning with busulfan.~   "
81448|NCT02500836|"~     Randomized, prospective, multi-center, double blind placebo-controlled parallel group study~     of a Placebo Topical Solution versus Cocaine HCl 4% Topical Solution for safety and efficacy,~     and Cocaine HCl 4% and 10% Topical Solution for Safety as an anesthetic prior to a diagnostic~     procedure or surgery on or through accessible mucous membranes of the nasal cavities. Both~     domestic (United States) and foreign sites are eligible, and both inpatient and outpatient~     settings are eligible.~   "
81449|NCT02500823|"~     Compelling epidemiological evidence indicates that alterations of mitochondrial DNA,~     including mutations and abnormal content of mitochondrial DNA (mtDNA), are associated with~     the initiation and development of cardiovascular disease. This study was undertaken to~     investigate whether mtDNA copy number in peripheral blood cells could be used as a risk~     predictor for coronary heart disease.~   "
81450|NCT02500810|"~     The purpose of this study is to determine whether monosialoganglioside are effective in the~     prevention of neurotoxicity induced by albumin-bound paclitaxel chemotherapy in lung cancer~     patients, and improve the quality of life of patients.~   "
81451|NCT02500797|"~     This randomized phase II trial studies how well nivolumab with or without ipilimumab works in~     treating patients with sarcoma that has spread from the primary site to other parts of the~     body or cannot be removed by surgery. Monoclonal antibodies, such as nivolumab and~     ipilimumab, may block tumor growth in different ways by targeting certain cells. It is not~     yet known whether nivolumab works better with or without ipilimumab in treating patients with~     metastatic or unresectable sarcoma.~   "
81452|NCT02500784|"~     The purpose of this study is to test the effects of long-term therapeutic doses of~     formoterol, on a) cerebrospinal fluid (CSF) tau levels, and Amyloid Beta protein 40/42 levels~     in the CSF, and b) cognitive function in people with mild to moderate Alzheimer' Disease~     (AD).~   "
81479|NCT02500433|"~     OBJECTIVE: To investigate whether VR videogames plus conventional therapy improves motor~     control compared with conventional therapy in children with cerebral palsy (CP).~      METHODS: Thirty participants with CP were included. A baseline (A0), a post-conventional~     intervention (A1), a post-experimental treatment (A2) and a two-month follow-up (A3)~     assessment were performed. Experimental intervention was based on videogames treatment~     (Kinect-Kbox360TM) added to their conventional physiotherapy. Motor and the process skills~     were evaluated by the Assessment of Motor and Process Skills (AMPS); balance by the Pediatric~     Reach test (PRT); gait speed by the 10-meters walk test (10MW); and running and jumping~     capacity by the Gross Motor Function Measure (GMFM).~   "
81480|NCT02500420|"~     Hypertrophic cardiomyopathy (HCM) is a primitive myocardic disease and the first of genetic~     cardiac diseases. The definition of HCM is an increase of the myocardial thickness of the~     left ventricle (LV) wall without any other causes of hypertrophy. It's characterized by an~     important heterogeneity of prognosis and clinical expression going from a asymptomatic state~     until the devastating sudden death occurring in a young person.The diagnosis of HCM is~     definite by a myocardial thickness greater or equal to 15mm (or 13mm if there is a familial~     history).This hypertrophy is often accompanied by other abnormalities detected by~     echocardiography: dynamic left ventricular outflow obstruction at rest or stress, mitral~     regurgitation …Now, the current challenge is to determine the prognosis factors of the~     disease that could help to identify the patients with high risk of sudden death. Some~     prognosis factors are knowed and used in the calculation of a new risk score. This risk score~     allows to estimate the risk of sudden death at 5 years and propose depending on the result,~     the implantation of a defibrillator for primary prevention.The physiopathological mechanism~     of HCM is very complex and still misunderstood. Myocardial fibrosis could be a major~     mechanism of the disease evolution. Indeed, fibrosis is responsible of scar areas where~     ventricular tachycardia may develop. Moreover, if the fibrosis is very extensive, it can be~     the responsible of a systolic or diastolic dysfunction of the left ventricle leading to heart~     failure.Myocardial ischemia caused by a microvascular dysfunction is now recognized as an~     important mechanism of the disease evolution. Acute ischemic events could be a trigger of~     malignant arrhythmia whereas chronic ischemia leads to fibrosis.Left ventricle function is~     long time preserved in HCM. Segmentary hypokinesia corresponding to extensive fibrosis~     appears at a very advanced stage of the disease. Exercice stress echocardiography permits to~     detect myocardial ischemia caused by microvascular dysfunction in the HCM before the fibrosis~     apparition. Moreover the investigators suggest to study the deformation parameters by speckle~     tracking or 2D strain witness of a contractile LV dysfunction before the apparition of~     segmentary hypokinesia.Magnetic resonance imaging (MRI) is now recognized as the more~     sensible technique to identify focal myocardial fibrosis resulting in areas of late~     gadolinium enhancement (LGE). LGE is frequent in HCM and his extension is correlated with the~     severity of the hypertrophy and the risk of sudden death. Myocardial ischemia is detected by~     hypoperfused defects in the perfusion sequences and as LGE, is correlated with the degree of~     hypertrophy. Some studies using stress MRI with vasodilatator agent show inductible~     hypoperfused areas correlated to the degree of hypertrophy. T1 mapping is a new hopeful~     sequence of MRI permitting to detect the diffuse and early myocardial fibrosis. Some studies~     show that T1 mapping values are reduced in the areas of LGE in HCM but also in areas without~     LGE which reflects the presence of new fibrosis.The objective of study is to compare these~     two imagery techniques in order to detect ischemia and fibrosis. These techniques are usually~     used in the diagnosis or the monitoring of the disease. The investigators propose to realize~     an exercise stress echocardiography to study: the segmentary kinetic of the left ventricle~     and the 2D strain and a stress MRI to study the LGE, the stress perfusion and the T1~     mapping.Actually the investigators consider that LGE is a risk factor of the disease~     (although not yet involved in the calculation of the risk of sudden death) and need to be~     study in each MRI realized for HCM. From the same way, the investigators suggest to follow~     patients to determine if the abnormalities detected by these two techniques and particularly~     2D strain abnormalities, stress myocardial ischemia and T1 mapping abnormalities are~     prognosis factors of the disease and appear more precociously than LGE.~   "
81453|NCT02500771|"~     This is a project to be funded by a Fast-Track Small Business Innovative Research to build~     and test the feasibility of a new software prototype called V-Motive which will facilitate~     the combination of two proven autism behavioral interventions: Applied Behavior Analysis~     therapy (ABA) and Video Modeling (VM). The investigators will conduct a Phase I feasibility~     analysis and Phase II pilot study of the V-Motive Prototype by observing a community therapy~     providers' use of the prototype in a therapy setting. Investigators will observe the users~     and record the success or failure of the performance of key functions of the software.~     Investigators will also administer surveys. The study will answer research questions about~     V-Motive's ability to perform its intended function: allowing interventionists to feasibly~     leverage video modeling within ABA therapy with a minimal amount of overhead and labor.~   "
81454|NCT02500758|"~     Despite the wide variety of products and antiseptic agents, no agent is ideal for every~     situation. The investigators would like to evaluate the difference in reducing bacterial~     load, using 4% chlorhexidine digluconate and 3% parachlorometaxylenol after a preoperative~     surgical scrubbing.~   "
81455|NCT02500745|"~     After obtaining a consent, bed side cardiac ultrasonography will be performed for cases~     undergoing transesophageal echocardiography to evaluate the correlation between left atrium~     volume and left atrial appendage flow velocity which can predict the thrombosis risk.~   "
81456|NCT02500732|"~     Objective: To determine if atomoxetine 40 mg bid in patients ≥18 years old with recurrent~     vasovagal syncope will better prevent syncope during tilt testing than placebo.~   "
81457|NCT02500719|"~     The purpose of the current study is to develop a better understanding of the brain mechanisms~     involved in psychological treatments for posttraumatic stress disorder (PTSD). This project~     will build on past research using script-driven imagery in our lab by investigating brain~     activity in areas activated during exposure to trauma-related cues. This project will also~     develop new knowledge concerning volitional control of those areas. The ultimate goal of this~     study is a better understanding of whether volitional control of these brain areas will~     improve therapeutic outcomes. This process will first be piloted in a sample of healthy~     controls. This will allow investigators to refine the methodology prior to recruiting a~     sample with PTSD.~   "
81458|NCT02500706|"~     This trial is conducted in Asia, Europe and North America. The purpose is to confirm efficacy~     in terms of glycaemic control of treatment with mealtime faster-acting insulin aspart in~     combination with insulin degludec in adults with Type 1 Diabetes Mellitus.~   "
81459|NCT02500693|"~     This trial is intended to evaluate the value of circulating tumor cells (CTC), in combination~     with unenhanced (without injection of contrast media) low dose (to limit the effective~     radiation dose below 1,5 mSv) chest computed tomography (LDCT) in the screening of Lung~     cancer (LC).~      LDCT screening was shown to reduce LC mortality in smokers and ex-smokers, older than 55~     years, with a history of more than 30 pack-years. LDCT however shows a close to 30% rate of~     false positive that require repeat follow-up and also invasive investigations, but also false~     negatives with metastatic LC being discovered between screening rounds.~      Migration of circulating tumor cells (CTC) is an early event of carcinogenesis and~     characterizes aggressive cancers. We recently showed that CTC can be detected with the ISET~     technique in a population at high risk for LC, i.e. COPD patients before LC was detectable on~     LDCT.~      The study will focus on patients at very high risk for lung cancer i.e. smokers and~     ex-smokers suffering Chronic Obstructive Pulmonary Disease (COPD).~      The study will enroll 600 participants who will undergo three rounds of screening at one year~     intervals, each round combining search for CTC on a blood sample and LDCT. Each participant~     will be followed for at least one year after the last screening round~   "
81460|NCT02500680|"~     The purpose of this study is to evaluate the safety, tolerance, and immunogenicity of~     MAS-1-Adjuvanted seasonal inactivated influenza vaccine (IIV) (MER4101) with hemagglutinin~     dose escalation compared to non-adjuvanted comparator IIV standard dose (SD) in healthy~     adults and high dose (HD) IIV in ambulatory elderly subjects.~      Hypothesis: Reduced HA dose IIV formulated in MAS-1 adjuvant (MER4101) has been shown under~     Phase 1A to be safe, tolerable and demonstrated a more robust and durable immune response to~     IIV over 6 months post-vaccination in healthy young adults 18 - 49 years of age compared to~     SD IIV. Under phase 1B the 9 µg/HA dose of IIV in 0.3 mL MAS-1 was safe and well tolerated~     and immunogenically comparable or superior to 60 µg/HA HD IIV control. It is anticipated that~     the increased dose of MAS-1 (0.3 mL vs 0.5 mL) at 9 µg/HA IIV and an increased dose of HA (15~     µg/HA vs 9 µg/HA) in the 0.5 mL dose of MAS-1 will be safe well tolerated and more robustly~     immunogenic in adults who are 65 years of age and older compared to HD IIV.~   "
81461|NCT02500667|"~     The present study is designed to assess the effects of Rifampin on the pharmacokinetics of~     N91115 in healthy subjects.~   "
81462|NCT02500654|"~     The purpose of the study is to evaluate if surgical treatment of peri-implantitis with enamel~     matrix derivative (Emdogain®, EMD) will have an additional effect on the healing outcome,~     changes in the peri-implant microflora and on the inflammatory response in the periimplant~     pocket at 12 months.~   "
81463|NCT02500641|"~     Comparison of the effects of Febuxostat and Allopurinol on Pulse Wave Velocity (PWV) after 36~     weeks of treatment.~   "
81464|NCT02500628|"~     Diseases caused by brain energy supply defects can be innate (fibromyalgia secondary to~     familial mitochondrial disorders) or acquired (tardive dyskinesia or weight gain associated~     with prolonged antipsychotic use). Patients with these possible mitochondrial disorders will~     provide a baseline resting heart rate sample, ingest low-dose metformin (500 mg), and then~     provide an additional sample 2 hours later.~   "
81465|NCT02500615|"~     This study examines the acute effects in ECIG users of the two primary vehicles in ECIG~     liquids, propylene glycol and vegetable glycerin. Thirty experienced ECIG users will use an~     ECIG in five conditions that will differ only by the propylene glycol:vegetable glycerin~     ratio: 100:0, 70:30, 50:50, 30:70, and 0:100 (device voltage, heater resistance, liquid~     nicotine concentration, puff number, and interpuff interval all will be held constant).~     Plasma nicotine concentration, subjective effects, and puffing behaviors will be recorded in~     each condition.~   "
81466|NCT02500602|"~     The proposed study will examine the efficacy of doxazosin in the treatment of PTSD and~     alcohol use disorder or substance use disorders.~   "
81467|NCT02500589|"~     Smoking is the leading cause of morbidity and mortality in the U.S. Interventions that~     increase successful quit attempts among depressed smokers with chronic medical illnesses are~     particularly important for the VA healthcare system because rates of tobacco use, depression,~     and chronic medical illnesses are significantly higher among Veterans compared to the general~     population. Providing smoking cessation services augmented with mood management to Veterans~     via telephone may increase access to, and utilization of, evidence-based smoking cessation~     counseling and decrease rates of smoking-related complications for Veterans with chronic~     medical illnesses and depression. Yet, the reach of smoking cessation telephone counseling~     has been limited among populations with mental illness. The investigators intend to combine~     the potency of co-delivered mood management and reach of telephone-delivered interventions by~     testing the telephone delivery of behavioral mood-management for smoking cessation among~     smokers with depression and chronic medical illness.~   "
81468|NCT02500576|"~     The goal of this clinical research study is to learn if pembrolizumab, an infusion of~     T-cells, chemotherapy (cyclophosphamide and fludarabine), and either high or low dose~     interleukin-2 (IL-2) can help to control metastatic melanoma. The safety of this drug~     combination will also be studied.~      T-cells are white blood cells in your body that are important to the immune system. The~     T-cells used in this study will be collected and grown in a separate study (MD Anderson~     Protocol 2004-0069)~      This is an investigational study. Cyclophosphamide is FDA approved and commercially available~     for the treatment of several types of cancer such as leukemia, lymphoma, and breast cancer.~     Fludarabine is FDA approved and commercially available for the treatment of B-cell chronic~     lymphocytic leukemia. It is considered investigational to give cyclophosphamide and~     fludarabine to treat melanoma.~      High dose IL-2 is FDA approved and commercially available for the treatment of metastatic~     melanoma and a type of kidney cancer. If you are assigned to receive low-dose IL-2, the drug~     will be provided by the supporting company Prometheus at no cost to you.~      Pembrolizumab is FDA approved and commercially available for the treatment of melanoma.~      T-cells are not FDA approved or commercially available. This therapy is currently being used~     for research purposes only.~      The study doctor can explain how the study drugs are designed to work.~      Up to 36 participants will be enrolled in this study. All will take part at MD Anderson.~   "
81469|NCT02500563|"~     This clinical trial will evaluate the stool of infants fed one of two infant formulas, which~     contain different types of proteins, or breast milk to determine if different proteins have~     an effect on the type of bacteria that enters and lives in an infant's intestine early in~     life.~   "
81470|NCT02500550|"~     The purpose of this study is to determine whether a repeat dose administration of ATIR101 is~     safe and effective when infused in patients with a hematologic malignancy following a T-cell~     depleted stem cell graft from a related haploidentical donor. All patients are planned to~     receive two ATIR101 doses of 2×10E6 viable T-cells/kg, unless the second dose is reduced or~     halted for safety reasons.~   "
81471|NCT02500537|"~     A post-market study of the Endo GIA™ Reinforced Reload with Tri-Staple™ Technology.~   "
81472|NCT02500524|"~     To assess the efficacy and safety of 10% Cocamide DEA and Lyclear creme rinse (permethrin1%)~     in the eradication of head lice. To assess the ability of each product to kill all viable ova~     and to assess patient acceptability of the product in use.~   "
81473|NCT02500511|"~     To determine the persistence of protective antibody levels for subjects who seroconverted~     after vaccination with NmVac4-A/C/Y/W-135-DT™~      Participants in trial # JN-NM-002, who seroconverted for serogroups A and C will be contacted~     and asked to provide a blood sample at 12-24 months after vaccination with~     NmVac4-A/C/Y/W-135-DT.~      Serum Bactericidal Assays will be performed to evaluated duration of protective antibody~     titer for NmVac4-A/C/Y/W-135-DT for all four serogroups. To determine if subjects who~     seroconverted with lower titers retain protective levels of antibody (titer ≥:8) at 12-24~     months after vaccination.~   "
81474|NCT02500498|"~     The study is a retrospective cohort study that utilizes medical records from the BiologicTx.~     Data accrual starts upon initial home infusion nurse visit until the most recent home~     infusion nurse visit. Infusion related adverse events are quantified as number of patients~     with adverse event over the total number of patients and number of event over total number of~     home infusion visits.~   "
81475|NCT02500485|"~     The purpose of the study is to investigate the potential interaction between multiple oral~     doses of SHR3824 and multiple oral doses of SP2086 in healthy adult volunteers.~   "
81476|NCT02500472|"~     This is a non-therapeutic, single-arm pilot clinical trial in adult healthy smokers to assess~     whether kava can alter NNK metabolism in humans.~   "
81477|NCT02500459|"~     Topotecan is an FDA-approved drug when given by intravenous infection. The purpose of this~     study is to determine if treatment with topotecan by an alternative method, direct delivery~     into the part of the brain where the tumor has spread, is safe and well tolerated. The~     Cleveland Multiport Catheter is a new, investigational device that will be used to deliver~     topotecan into tumor-infiltrated brain. A second purpose of this study is to determine~     whether the Cleveland Multiport Catheter can be used effectively and safely to deliver~     topotecan into tumor-infiltrated brain. This study will also examine how tumors responds to~     treatment with topotecan. This study will also look at the way topotecan is injected into~     tumors-infiltrated brain. A small amount of contrast dye (called gadolinium DTPA) will be~     added to topotecan before it is injected. Pictures will be taken of the brain with an MRI~     machine. This will allow the investigators to see where in the tumor-infiltrated brain the~     topotecan has been injected. This study will collect medical information before, during, and~     after treatment in order to better understand hot to make this type of procedure accessible~     to patients.~   "
81478|NCT02500446|"~     Several studies have suggested that despite suppressive combination antiretroviral therapy~     (ART) in people who are HIV-positive, in some individuals there may be on-going viral~     replication. Clarifying the extent of on-going viral replication on ART is important for the~     development of HIV-1 curative strategies and for reducing HIV-1 associated immune activation.~     The investigators hypothesize that treatment intensification with dolutegravir will inhibit~     residual virus replication in HIV-1 infected patients on ART. The primary objective of this~     study is to determine the effects of dolutegravir intensification on residual virus~     replication in circulating cluster of differentiation 4 (CD4+) T cells.~   "
81482|NCT02500394|"~     This study evaluates the impact of a biomarked guided intervention on the development of~     acute kidney injury in high risk surgical patients. Eligible patients are screened for marker~     of tubular stress in the urine; if patient specific results are above a pre-defined cutoff~     they are randomized into a standard care group or an interventional group in which patients~     receive intensified volume therapy.~   "
81483|NCT02500381|"~     The main objective of this study is to evaluate the efficacy of SRP-4045 and SRP-4053~     compared to placebo in Duchenne muscular dystrophy (DMD) patients with out-of-frame deletion~     mutations amenable to skipping exon 45 and exon 53, respectively.~   "
81484|NCT02500368|"~     This is a 1-week dispensing, double-masked, randomized, bilateral study comparing the test~     lens against the control lens.~   "
81485|NCT02500355|"~     Carpal Tunnel Release via Two Small Incisions Comparing With via Standard Incision And Under~     Endoscope.~   "
81486|NCT02500342|"~     Thyroid hormone is a key regulatory hormone for a range of physiological systems. An impaired~     function of the thyroid gland such as subclinical hypothyroidism (SCH) can affect quality of~     life. Older adults with subclinical hypothyroidism often report non-specific symptoms such as~     tiredness. In addition, muscle symptoms such as cramps, weakness and myalgia are more common~     in SCH than in healthy controls. At present, evidence is lacking about the benefits of~     thyroxine replacement in the elderly with SCH, as no large randomized clinical trials (RCT)~     on the full range of relevant clinical outcomes, including tiredness have been performed.~     Moreover, there is continued uncertainty about the long-term impact on health related quality~     of life of thyroxine treatment for SCH. The aim of the study is to examine, within a large~     RCT of elderly participants with subclinical hypothyroidism, the impact of thyroxine therapy~     on the association between subclinical thyroid disease (SCTD) and the level of physical and~     mental fatigue. The existing trial infrastructure (TRUST thyroid trial-Euresearch FP7;~     clinicaltrials.gov ID: NCT 01660126) will be utilized to collect information on the level of~     physical and mental fatigue by using the Pittsburgh Fatigability Scale at baseline and at 1~     year from 220 participants with persistent subclinical hypothyroidism randomized to either~     thyroxine or placebo.~   "
81487|NCT02500329|"~     This is a phase 4, single center, randomized, open-labeled study. The primary objective of~     the study is to compare effect of gemigliptin and acarbose on endothelial function.~      Subjects are randomized to gemigliptin or acarbose group and maintained intial treatment for~     4 weeks.~   "
81488|NCT02500316|"~     Protocol CP-4-004-EXT is designed as a long-term, open-label extension using single patient~     use, multi-dose, disposable pre-filled pen.~   "
81489|NCT02500303|"~     The purpose of this study is to explore the factors that influence limb fitting in those with~     diabetes compared to those without diabetes. The population without diabetes will usually~     present with peripheral arterial disease (PAD) and are similar in management following LEA.~     The impact that not walking with a prosthesis has long term on both populations will be~     explored. In general, previous research has used retrospective analysis of case notes which,~     although valuable, have fixed fields and only allow the researcher to look at associations~     between factors not at causation. Additionally, very few have followed a population over~     time. Therefore this study will be a prospective observational analysis of all those who~     undergo a LEA in one year from 01/03/14 to 28/02/15 within the Greater Glasgow & Clyde area~     with follow up at 6, 12 & 18 months from date of amputation.~   "
81490|NCT02500290|"~     This study aims to describe antiplatelet therapy in ACS in Andalusia and make an assessment~     of efficacy and safety of hospital use Prasugrel / ticagrelor vs. Clopidogrel and Prasugrel~     switching to / ticagrelor patients pretreated with clopidogrel.~   "
81491|NCT02500277|"~     This is a prospective study to assess the yield of pleural biopsy obtained with the routine~     flexible thoracoscopic biopsy forceps versus that obtained with a flexible cryoprobe during~     semirigid thoracoscopy~   "
81492|NCT02500264|"~     The aims of the study: To evaluate whether the use of a specific TENS technology can improve~     GERD symptoms and esophageal acid exposure.~   "
81493|NCT02500251|"~     This study is a prospective, open label, phase I/II pilot study.~   "
81494|NCT02500238|"~     Electronic cigarette use may be less harmful than cigarettes in adults, however, limited data~     exists examining passive electronic cigarette exposure and child health outcomes. The current~     study seeks to compare health-related outcomes among youth who reside with non-smokers,~     cigarette smokers, and electronic cigarette users. The investigators propose to conduct a~     small pilot study with 30 youth, ages 6-17 and a caregiver. Three groups of 10 parent-child~     dyads will be recruited: 1) control group: parents who are non-smokers/non-vapers, 2) smoking~     group: parents who are exclusive cigarette smokers, and 3) vaping group: parents who are~     exclusively ECIG users. Groups will be compared across the following variables: child lung~     function and biomarkers of nicotine.~   "
81495|NCT02500225|"~     The purpose of the study was to investigate the effects of etomidate or sevoflurane used in~     electroconvulsive therapy (ECT) on duration of seizure, hemodynamic response and recovery~     profiles.~   "
81496|NCT02500212|"~     Open-label, multicentre, randomized clinical trial to compare the pharmacokinetics of~     ENVARSUS® tablets and ADVAGRAF® capsules administered once daily in adult de-novo kidney~     transplant patients.~   "
81497|NCT02500199|"~     Part 1: to assess the safety and tolerability of pyrotinib and to define the maximum~     tolerated dose (MTD) of pyrotinib in patients with Human Epidermal Growth Factor Receptor 2~     (HER2)-positive advanced solid tumors (metastatic breast cancer, gastric cancer, or other~     solid tumors that have no targeted agent as standard of care).~      Part 2: to estimate the overall response rate (ORR) for patients with HER2-positive~     metastatic breast cancer (mBC) and HER2 mutant non-small cell lung cancer (NSCLC) treated at~     the RP2D (or MTD).~   "
81498|NCT02500186|"~     The objectives of this clinical study is to assess the effect of the amount of carbohydrate~     intake and meals differing in glycemic index (GI) in patients of type 2 diabetes mellitus~     treated with an SGLT2 inhibitor (Luseogliflozin), which inhibits glucose reabsorption from~     renal uriniferous tubule, on glucose variability by using continuous glucose monitoring~     (CGM), and to establish dietary therapy which reduces the risk of hypoglycemia in patients~     treated with SGLT2 inhibitors. In addition, blood and urine samples are collected for~     metabolome analysis that will be performed as an extension study of the clinical study.~   "
81499|NCT02500173|"~     To collect and analyze effects and side effects in patients undergoing radiotherapy.~      This study investigates how analysis of effects and side effects will influence outcome of~     patients. These retrospectively collected data allow to adapt and improve radiotherapy~     treatment regimens .~   "
81500|NCT02500160|"~     Patient-specific instrumentation (PSI) has been introduced in total knee arthroplasty (TKA)~     as a new technology for improving accuracy in restoration of the alignment and biomechanics~     of the lower limb. PSI in TKA refers to custom-made cutting jigs manufactured according to~     the patient's anatomic configuration of distal femur and proximal tibia based on preoperative~     magnetic resonance imaging (MRI) or computed tomography (CT) scans. MRI- and CT-based PSI~     systems are available from various manufacturers for preoperative planning. MRI offers~     precise visualization of articular cartilage without the risk of radiation exposure, but it~     is expensive and requires long scan times. In contrast, CT enables accurate identification of~     the contour of the femur and tibia at short scan times, but it does not provide information~     on the cartilage thickness and carries the risk of radiation exposure. As a result, there is~     a possibility of some discrepancy between the thickness of bone resection proposed by MRI- or~     CT-based PSI system and the actual thickness of bone cut. Although PSI has been the focus of~     study in many recent researches, there has been no clinical study comparing MRI-based and~     CT-based PSI systems in preoperative planning. Therefore the investigators questioned whether~     the MRI-based PSI that reflects the cartilage layer would provide more precision in TKA than~     the CT-based PSI. The purpose of this study was to investigate the accuracy of MRI-based PSI~     and CT-based PSI in predicting bone resection thickness in TKA.~   "
81501|NCT02500147|"~     This project, A double-blind placebo-controlled randomized clinical trial assessing the~     efficacy of metformin for hepatic fat in adolescents and young adults with polycystic ovary~     syndrome, proposes exploring the use of novel and noninvasive methodologies in an at-risk~     adolescent and young adult population with polycystic ovary syndrome (PCOS) who may gain~     long-term health benefits from early detection and treatment of non-alcoholic fatty liver~     disease (NAFLD). PCOS is a common condition that frequently presents in adolescence and young~     adulthood and is defined by elevated androgens (male hormones) in the blood leading to 1.~     hirsutism and acne and 2. menstrual abnormalities or amenorrhea. Affected individuals are at~     increased risk of developing insulin resistance (a precursor of diabetes), NAFLD and lipid~     (cholesterol) abnormalities.These features are all associated with the metabolic syndrome, a~     rising major public health concern. Recently, an association between PCOS and NAFLD has been~     noted but has only been superficially studied in the adolescent and young adult population.~     The susceptibility of certain PCOS patients to developing NAFLD is theorized to be due to~     having underlying insulin resistance, elevated androgen levels, and a genetic predisposition.~     Metformin is an insulin sensitizing medication widely used to treat type 2 diabetes mellitus~     that may have beneficial effects on insulin resistance-related conditions including PCOS and~     NAFLD. Although widely used in PCOS, its effect on NAFLD in this group has not been~     previously studied.~      The primary aims of this proposal are: 1) To determine whether PCOS with liver fat >/=4.8%~     treated with metformin for six months will have a decline in percentage liver fat compared to~     a placebo group. 2) To measure the association of the PNPLA3 I148M allele with NAFLD in PCOS~     at baseline (n=40). 2b) To measure the association of percentage liver fat with biomarkers of~     NAFLD, dyslipidemia, insulin resistance and body composition at baseline (n=40) and after a~     placebo-controlled intervention with metformin in PCOS with liver fat >4.8% (n=20).~      The goal of this research proposal is to explore the use of novel and noninvasive~     technologies in a young and at risk population. Dr. Sopher hopes to use the results of this~     research to lay the groundwork for the prevention and treatment of NAFLD and other metabolic~     disorders in adolescents and young adults with PCOS and to prevent lifelong morbidity~     associated with PCOS.~   "
81502|NCT02500134|"~     The limbus located between the cornea and the conjunctiva tissue, is important for not only~     providing a barrier frontier to prevent conjunctival tissue invasion into the cornea,~     containing nerves passing to the cornea, having blood and lymph vasculature for oxygen and~     nutrient delivery, but also the niche environment of limbal stem cells.~      So far, in vivo image systems are not able to visualize or identify the limbal stem cells~     directly. One alternative practical is to visualize the histological morphology of palisades~     of Vogt (POV), and to speculate the possible status of the stem cells accordingly. Slit-lamp~     biomicroscope can be used routinely for clinical examination of the limbal morphology.~     However, this technology does not allow for high resolution imaging of structural details and~     only up to 20% of patients can be identified. In vivo confocal microscopy has been used to~     visualize the POV and can provide cellular level resolution images, but the technique is~     limited by high magnification that restricts the area of the scan, and requires contact with~     the eye. Besides, both slit lamp biomicroscopy and in vivo confocal microscopy have the~     limitation of not being able to give an overall view of the dimension and structure of the~     whole palisades region.~      Anterior segment optical coherence tomography (AS-OCT) is a noninvasive, rapid and~     reproducible technique to evaluate the anterior segment and can also provide in vivo spatial~     information. The purpose of the study is to assess the role of aging and regions on the~     limbus.~   "
81503|NCT02500121|"~     This is a multi-institutional, randomized, placebo controlled, double-blinded phase II trial~     of maintenance pembrolizumab versus placebo after first-line chemotherapy in patients with~     metastatic urothelial cancer who have achieved at least stable disease on first-line~     chemotherapy.~   "
81504|NCT02500108|"~     The purpose of this study is to assess the risk of serious cardiac events, specifically~     ventricular tachyarrhythmia and sudden cardiac death (VT/SCD), associated with the use of~     domperidone in a population of patients with Parkinson's disease. The hypothesis for this~     study is that the risk of VT/SCD will be higher among domperidone users, especially at a~     higher dose.~      The investigators will conduct a retrospective population-based cohort study using health~     care databases in eight jurisdictions in Canada and the UK. The study cohort will be defined~     by the initiation of a new antiparkinsonian drug or a new diagnosis of Parkinson's disease.~     The results from the separate sites will be combined by meta-analysis to provide an overall~     assessment of the risk of VT/SCD in users of domperidone.~   "
81505|NCT02500095|"~     Background: Calorie restriction increases longevity in many species and attenuate the~     development of chronic disorders including type 2 diabetes, cardiovascular diseases and~     cancer. In mice reduced activity of insulin-like growth factor I (IGF-I) and/or insulin is~     associated with extended longevity. Growth hormone (GH) is the main regulator of IGF-I~     production, but the molecular mechanism whereby GH switches from IGF-I stimulation (protein~     anabolism) to fatty acid oxidation (fatty acid catabolism) as well as induction of insulin~     resistance during fasting remains enigmatic.~      Hypotheses: The changes of the global set of metabolites, induction of insulin resistance,~     and the shift in metabolism from protein anabolism to lipolysis together with the potentially~     favorable effect of calorie restriction during fasting depend on preserved fasting-induced GH~     secretion.~      Aim: The investigators wish to provide knowledge on changes in metabolites and shift in~     signaling pathways that take place at the transition to the fasting state among healthy~     overweight and obese subjects. Furthermore the investigators wish to determine the effect of~     GH on the adaption of the metabolism to a fasting state.~   "
81507|NCT02500069|"~     The appearance of intact macronutrients in the small intestine can result in the activation~     of an intestinal brake; a negative feedback mechanism from different parts of the intestine~     to the stomach, the small intestine and to the central nervous system. These processes~     inhibit food processing, appetite sensations and food intake, and furthermore they increase~     feelings of satiety and satiation. The researchers will investigate the effects of~     intraduodenal, intrajejunal and intralileal infusion of casein (protein) on ad libitum food~     intake, satiation and in vivo release of the gut satiety peptides CCK, PYY and GLP-1 and~     glucose and insulin.~   "
81508|NCT02500056|"~     The aim of the present study is to determine whether usage of mesh with larger pores,~     compared with mesh with smaller pores, would result in decreased rate of chronic pain after~     open inguinal hernia repair.~   "
81509|NCT02500043|"~     The purpose of this trial is to compare the effects of TAS-102 and best supportive care (BSC)~     with Placebo (an inactive drug) and best supportive care on metastatic gastric cancer.~   "
81510|NCT02500030|"~     Neuromuscular diseases (NMD) are characterized by a reduced maximum insufflation capacity~     (MIC), which contributes to increased morbidity and mortality from respiratory diseases.~     Techniques such as glossopharyngeal breathing (GPB) and insufflation using a manual~     resuscitation bag, or air stacking (AS), can be used to increase the MIC. These techniques~     employ different mechanisms, and the ability to learn the technique plays a key role in its~     proper implementation and effectiveness. The objective is compare the effects of AS and GPB~     on the MIC in patients with NMD.~      Children and adolescents with NMD who were users of non-invasive mechanical ventilation were~     recruited. Vital capacity (VC) and MIC were measured prior to and after the intervention with~     AS and GPB. Values were compared pre- and post-intervention and were considered statistically~     significant if p <0.05.~   "
81511|NCT02500017|"~     This is an 8-week randomized, double-blind, placebo-controlled, parallel, fixed-dose pilot~     clinical trial to test the effectiveness of melatonin treatment versus placebo on symptoms of~     Night Eating Syndrome (NES). The investigators will also look at the effect of melatonin~     treatment on weight, metabolic parameters and sleep parameters in individuals with NES.~   "
81512|NCT02500004|"~     To study BAT activity and energy metabolism in patients with cachexia induced by cancer or~     chronic disease.~   "
81513|NCT02499991|"~     Research shows that there are a plenitude of interventions that can be used to enhance memory~     for older adults; however, the evidence as to whether these interventions enhance memory for~     daily activities is equivocal. The purpose of this pilot study is to test a memory~     intervention that is potentially useful in everyday life. Objectives of the pilot study are:~     1) to examine the feasibility of the intervention (e.g., ease of use of materials provided);~     and 2) to gain preliminary evidence of the intervention's impact on recall of recent daily~     social events. Participants will be 20 cognitively healthy (i.e. not cognitively impaired)~     older adults, with 10 participants randomly assigned to either an intervention or control~     group, respectively. The study will consist of: a) a pre-training session; b) seven days of~     independent memory training; and c) a post-training session. The pre-training session will~     involve a test that measures recall of daily social events from the previous week. This will~     be followed by seven days of training for recall of daily social events. During the seven~     days, the intervention group will perform daily memory tasks using self-instructional~     materials given to them by the researcher, whereas the control group will use their own~     strategies for remembering social events that they are involved in during the week. The~     post-training session will occur after the seven days and will involve the same test as the~     pre-training session that measures recall of social events from the previous week. The~     hypotheses are that: a) recall of social events will be higher for the post-training test~     than in the pre-training test and; b) recall will be better for in the intervention group~     than the control group. The ease of use of the memory recall materials provided to the~     intervention group will be assessed in interviews.~   "
81514|NCT02499978|"~     This is a clinical research study to see if switching to Darunavir/Cobicistat ((PREZCOBIX™,~     DRV/COBI ) and Dolutegrivir (Tivicay®, DTG) in HIV-infected individuals with undetectable HIV~     viral load on nucleos(t)ide reverse transcriptase inhibitor (NRTI)-containing therapy will be~     effective in maintaining virologic suppression at 48 weeks of treatment.~   "
81515|NCT02499965|"~     The purpose of this study is to determine whether or not the pain of IV catheter insertion in~     the Emergency Department can be reduced significantly with the use of a rapid acting topical~     anesthetic spray and to determine whether or not healthcare providers who undergo such~     treatment are likely to endorse its use in their future practice.~   "
81516|NCT02499952|"~     This is an open label, multi-institutional, single arm phase II trial of pembrolizumab in~     patients with incurable platinum refractory germ cell tumors. No randomization or blinding is~     involved.~   "
81517|NCT02499939|"~     The primary purpose of the trial is to determine the preliminary efficacy of therapeutic~     ultrasound in the treatment of pain and sensory disturbance related to chemotherapy induced~     peripheral neuropathy.~   "
81518|NCT02499926|"~     This research study is investigating if consuming more of one amino acid (arginine)~     influences the digestion and absorption of another amino acid (lysine) due to competition in~     digestion, in a healthy adult population.~   "
81528|NCT02499796|"~     This study compares the short-term effects of a new humidification system (Hygrovent Gold)~     and two other humidification devices (heated and moisture exchanger and heated humidifier) on~     respiratory pattern and work of breathing, during invasive ventilation.~   "
81529|NCT02499783|"~     This study will evaluate the efficacy and safety of adalimumab induction and maintenance~     treatment in subjects with moderately to severely active Crohn's disease.~   "
81530|NCT02499770|"~     This is a study to investigate the potential clinical benefit of trilaciclib (G1T28) in~     preserving the bone marrow and the immune system, and enhancing chemotherapy antitumor~     efficacy when administered prior to carboplatin and etoposide in first line treatment for~     patients with newly diagnosed extensive-stage SCLC.~      The study consists of 2 parts: a limited open-label, dose-finding portion (Part 1), and a~     randomized double-blind portion (Part 2). Both parts include 3 study phases: Screening Phase,~     Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first~     dose with study treatment and completes at the Post-Treatment Visit. Approximately, 90~     patients will be enrolled in the study; 20 patients in the Part 1 and 70 patients in the Part~     2 portion.~   "
81519|NCT02499913|"~     Alcohol use and alcohol-related disorders are highly prevalent in soup kitchen users, and~     this population is overrepresented by minorities and disproportionately affected by~     alcohol-related morbidity and mortality. Contingency management is a behavioral intervention~     effective in reducing substance use, but few studies have evaluated the efficacy of~     contingency management in the context of soup kitchens or homeless programs. The~     investigators found that contingency management, using a twice weekly testing and~     reinforcement schedule, had benefits for decreasing drinking in individuals receiving~     services at a homeless shelter. This study will replicate and extend these earlier findings~     to a soup kitchen population using more sophisticated alcohol monitoring procedures to better~     assess the extent of drinking in this group and in response to a contingency management~     intervention reinforcing submission of negative breath samples. Specifically, 40 hazardous~     drinkers recruited from a soup kitchen will be randomly assigned to one of two conditions:~     alcohol monitoring or the same plus reinforcement for provision of daily negative breath~     alcohol samples. The interventions will be in effect for 3 weeks, and all participants will~     also wear transdermal continuous alcohol monitors during the intervention period. Objective~     and subjective indices of alcohol consumption will be evaluated and compared between and~     within the treatment conditions. This pilot project will provide information regarding the~     effect size of contingency management reinforcing negative breath samples in an important~     health disparities group, and results from this study will guide subsequent grant~     applications focusing on methods to decrease drinking in this underserved population.~   "
81520|NCT02499900|"~     The primary objective of this study is to compare patient medication satisfaction as measured~     by the Medication Satisfaction Questionnaire (MSQ) scores between the Copaxone 40 mg/mL three~     time a week (TIW) group and the Copaxone 20 mg/mL once daily (QD) group over 6 months of~     treatment.~   "
81521|NCT02499887|"~     The purpose of the proposed study is to determine whether the addition of inhaled~     corticosteroids to treatment with oral corticosteroids and albuterol would reduce repeat~     emergency department (ED) visits among patients treated for acute exacerbations of asthma and~     COPD discharged from the emergency department to home. The investigators hypothesize that~     patients treated with inhaled corticosteroids in addition to oral corticosteroids and~     albuterol will have lower rates of 30-day return visits to the emergency department than~     those patients treated with oral corticosteroids and albuterol only.~   "
81522|NCT02499874|"~     The purpose of the study is to measure the drug levels in your blood and to find out whether~     a reduced dose (400mg) of the anti-HIV medication Efavirenz is safe when taken during~     pregnancy.~      The study will recruit HIV infected women who take Efavirenz as part of their anti-hiv~     treatment and who are pregnant.~      Efavirenz has been shown to be safe in pregnancy and at the standard dose that everybody~     takes of 600mg once a day, it shows levels that are enough to treat HIV and give birth to a~     HIV negative baby.~      Efavirenz at a dose of 400mg once daily works against HIV too but this dose has not been~     given to HIV positive pregnant women.~      People with HIV may benefit from using a dose of efavirenz of 400mg instead of 600mg, as~     lower drug doses could have fewer side effects and be tolerated better.~      Dose reduction would also make the drug cheaper. This would allow more people to be treated~     and free up money for other important work in the fight against HIV such as education and~     prevention programs.~      However, it is not known whether 400mg of Efavirenz works as well as 600mg of Efavirenz~     during pregnancy and this is why the investigators are conducting this study, which aims to~     measure the amount of Efavirenz 400mg in HIV pregnant women's bodies when they are taking~     400mg of Efavirenz once a day.~   "
81523|NCT02499861|"~     This Phase I/IIa study will test the combination of the epigenetic drug decitabine with the~     isoflavone genistein in children with leukemias and solid tumors. For the phase I study, the~     maximum tolerated dose will be evaluated in pediatric patients with relapsed or refractory~     leukemia and solid tumors. For the phase II study, only patients with relapsed or refractory~     leukemias will be included. To further evaluate the treatment efficacy and gain further~     insight into action of these drugs, the DNA methylation levels before and after treatment for~     all participants, pharmacokinetics parameters such as through level for decitabine and~     through and peak level for genistein will be measured. Pharmacogenomics testing for~     decitabine will be performed prior to cycle 1 of treatment.~      Decitabine will be administered over a 24 hours infusion on day 1 of cycle (28 days) and~     genistein will be taken orally twice daily from day 2 to 21, followed by a 7 days rest~     period.~   "
81524|NCT02499848|"~     To Evaluate Safety, Tolerability and Potential Efficacy of PRX302 effect on clinically~     significant localised low to intermediate prostate cancer.~   "
81525|NCT02499835|"~     This randomized pilot trial studies vaccine therapy and pembrolizumab in treating patients~     with prostate cancer that does not respond to treatment with hormones (hormone-resistant) and~     has spread to other places in the body (metastatic). Vaccines made from deoxyribonucleic acid~     (DNA), such as pTVG-HP plasmid DNA vaccine, may help the body build an effective immune~     response to kill tumor cells. Monoclonal antibodies, such as pembrolizumab, may find tumor~     cells and help kill them. Giving pTVG-HP plasmid DNA vaccine and pembrolizumab may kill more~     tumor cells.~   "
81526|NCT02499822|"~     The purpose of this study is~        1. to compare the effects of nifedipine GITS and ramipril on blood pressure variability in~          subjects with elevated blood pressure variability.~        2. to assess whether the degree of treatment-induced changes in blood pressure variability,~          is related to the degree of regression (or progression) of organ damage in heart,~          kidneys and carotid arteries.~   "
81527|NCT02499809|"~     High intensity exercise can lead to muscle damage, resulting in muscle soreness, swelling and~     reduction in muscle strength. If the recovery is not sufficient or efficient it can increase~     the risk for injury and decrease the ability of the athlete to perform repetitive exercise~     and maintain overall performance.~      There are a variety of recovery aids which are being used by athletes, such as: the use of~     compression garments, massage, cold water immersion, sauna etc. Additional recovery strategy~     currently growing in popularity is the application of vibration.~      The evidences regarding the benefits of vibration therapy as a recovery aid are limited,~     specifically in athlete. Therefore, the proposed study will examine the use of vibration~     therapy as a recovery tool. The efficacy of this technique will be measure using functional~     and field tests.~   "
81531|NCT02499757|"~     The investigators' aim is to test the prediction that sweet taste perception enhances the~     ability of nicotine to induce neural plastic changes in brain reward circuits to increase the~     saliency, liking and brain reactivity to the sight and vaporized flavor of electronic~     cigarettes (e-cigarettes).~   "
81532|NCT02499744|"~     The investigators hypothesize that the Humidified High Flow Nasal Cannula(HHFNC) is effective~     and safe as primary respiratory support in neonate with respiratory distress syndrome(RDS).~     It is more convenient in HHFNC combined with kangaroo care.~   "
81533|NCT02499731|"~     Strong Hearts, Healthy Communities is a research study which aims to reduce cardiovascular~     disease (CVD), improve quality of life, and reduce CVD related health care costs in rural~     communities.~      The investigators' aim is to better understand how changes in lifestyle can affect the health~     of rural women and others in their communities.~   "
81534|NCT02499718|"~     Assessment of the effect and safety of noninvasive positive pressure ventilation for severe~     stable chronic obstructive pulmonary disease~   "
81535|NCT02499705|"~     The purpose of this study is to investigate the effects of dietary exposure to artificial~     sweeteners on taste sensitivity, preference and brain response in adolescents using fMRI,~     psychophysical measures, and questionnaires. The investigators hypothesize that dietary~     exposure to artificial sweeteners (sucralose) will decrease sensitivity to taste, shift~     preference of sweet and savory taste to a higher dose, and reduce brain response in amygdala~     to sweet taste compared to sucrose.~   "
81536|NCT02499692|"~     Prospective, multicenter, single-arm study, enroll 100 patients in no more than 10 sites~     across China, the primary endpoint is Technical success.~   "
81537|NCT02499679|"~     The objective of the HeartFlow ADVANCE Registry is to evaluate utility, clinical outcomes and~     resource utilization of FFRCT-guided evaluation in clinically stable, symptomatic patients~     with coronary artery disease (CAD) in order to further inform patients, health care~     providers, and other stakeholders about which technologies are most effective and efficient~     in the diagnosis and management of CAD.~   "
81538|NCT02499666|"~     The purpose of this project is to objectively assess the change (improvement) in exercise~     capacity in patients undergoing routine percutaneous coronary intervention (PCI) for chronic~     total occlusion (CTO)~   "
81539|NCT02499653|"~     This study aims to analyze the impact of a brief psychological support intervention in the~     promotion of the adherence to Non Invasive Ventilation (NIV) among people with Chronic~     Obstructive Pulmonary Disease (COPD). The investigators expect to see a positive impact of~     this intervention on both physical and psychological well-being, and consequently, a~     reduction of health costs.~   "
81540|NCT02499640|"~     The aim of the present study was to investigate the effects of cold water immersion (CWI)~     during post-exercise recovery with different durations and temperatures on heart rate~     variability (HRV) indices. 100 participants performed a protocol of jumps and a Wingate test,~     and immediately afterwards were immersed in cold water, according to the characteristics of~     each group (CG: control; G1: 5' at 9±1°C; G2: 5' at 14±1°C; G3: 15' at 9±1°C; G4: 15' at~     14±1°C). Analyses were performed at baseline, during the recuperative technique (TRec) by CWI~     and 20, 30, 40, 50 and 60 minutes post-exercise. The HRV indices average of all RR intervals~     in each analysis period (Mean RR), standard deviation of normal R-R intervals (SDNN), square~     root of the mean of the sum of the squares of differences between adjacent R-R intervals~     (RMSSD), spectral components of very low frequency (VLF), low frequency (LF) and high~     frequency (HF), scatter of points perpendicular to the line of identity of the Poincaré Plot~     (SD1) and scatter points along the line of identity (SD2) were assessed. Comparisons between~     groups and moments were performed using the technique of analysis of variance for repeated~     measures in two scheme factors. A significance level of p<0.05 was considered.~   "
81541|NCT02499627|"~     This is a single-arm, open-label, multicenter, phase 2 clinical trial aimed at evaluating the~     efficacy and safety of the combination of bendamustine and brentuximab vedotin as a first~     salvage therapy in patients with relapsed or refractory Hodgkin's lymphoma or PTCL.~      A total of 25 patients with PTCL, and 40 with Hodgkin's lymphoma are expected to be treated~     according to this treatment protocol.~   "
81542|NCT02499614|"~     Phase II, two arms, parallel, non comparative study with crizotinib in patients with ROS 1~     translocation or MET amplification or MET exon 14 mutation~   "
81543|NCT02499601|"~     The study objective is to demonstrate safety and feasibility of the CORolla® TAA during 12~     months of follow up, and to evaluate the performance of the therapy in relieving symptoms and~     restore diastolic function in patients with heart failure and preserved ejection fraction.~   "
81544|NCT02499588|"~     The primary aim of this study is to demonstrate the maintenance of healthy peri-stomal skin~     over a two month period in subjects who use ConvaTec Moldable Technology™ Skin Barriers as~     part of their standard protocol of care following surgery.~   "
81545|NCT02499575|"~     Exparel is an FDA-approved local anesthetic (bupivacaine), in a long-release formulation. In~     this study the investigators plan to determine the ability of Exparel to control~     post-operative pain in common first metatarsophalangeal (MTP) joint procedures (bunion~     surgery, 1st MTP fusion, and cheilectomy).~   "
81546|NCT02499562|"~     To explore the effective dose and safety of the effect of hydronidone and entecavir on~     hepatic fibrosis in chronic viral hepatitis B.~   "
81547|NCT02499549|"~     To assess the efficacy and safety of 10% Cocamide DEA using two treatment regimens in the~     eradication of head lice. To assess the ability of each treatment regimen to kill all viable~     ova and to assess patient acceptability of the product in use~   "
81548|NCT02499536|"~     The aim of this study is to find out relationship between PaO2/FiO2 and atelectasis finding~     on intraoperative lung ultrasound.~   "
81549|NCT02499523|"~     A prospective, interventional, monocentric, controlled and randomized study will compare a~     conventional surgical technique to a surgical technique with the assistance of the Acetabular~     Cup Orientation Guide (ACOG, Materialise) System during total hip replacement (THR).~   "
81550|NCT02499510|"~     The GoldenFlow (Lifetech Scientific, Shenzhen, China) is a novel woven-nitinol stent designed~     to have superior radial strength, flexibility and durability compared to standard nitinol~     stents for femoropopliteal lesions. This is a first-in-man study to evaluate the safety and~     efficacy of GoldenFlow woven-nitinol stent for intraluminal treatment of peripheral vascular~     disease in the femoropopliteal arteries.~   "
81551|NCT02499497|"~     This research study is studying the use of a targeted therapy called LY SARM, which is an~     investigational drug from a new class of molecules called Selective Androgen Receptor~     Modulators (SARMs) as a possible improvement in quality of life for participants who have~     undergone radical prostatectomy. Androgens are a group of hormones that play a role in male~     traits and reproductive activity.~      The names of the study interventions involved in this study are:~      - LY2452473~   "
81552|NCT02499484|"~     The primary objective of this research is to determine if the addition of topical GTN over 24~     weeks to a 12 week exercise programme improves clinical outcomes more than placebo GTN for~     people with Achilles Tendinopathy.~      Pain in the Achilles tendon is a common condition seen by physiotherapists and doctors. It~     affects people involved in sports and those who are not. It can limit the ability to walk,~     hop, jump and run. If the pain persists for longer than 3 months it can become extremely~     difficult to abolish. As a result, people with this common condition can suffer from~     prolonged pain and often the pain will persist and affect everyday activities.~      While this is an easy injury to diagnose, it is not so easy to treat. Many treatments do~     exist, but often just provide short-term relief until the pain returns. Specific~     strengthening exercises have been shown to be beneficial in treating this condition.~      The current project will study Achilles tendon pain in Irish adults at Connolly Hospital,~     Dublin, and will take place from 2015 to 2019. In this study, there are two groups of~     patients. Both groups will perform an exercise program for 12 weeks. Physiotherapists will~     instruct them on how to perform the exercises. Each group will be given an ointment to place~     on the sore tendon using an applirule. This ointment will be applied daily for 6 months. One~     group will use an ointment containing nitroglycerin, the other group will use an ointment~     with no active ingredient. This is called a placebo. The patients will apply the ointment~     daily for 6 months.~      The patients will be assessed at the start of the program and after 6, 12 and 24 weeks. Our~     main question is to see whether this exercise program when combined with a nitroglycerin~     ointment applied directly over the sore tendon can improve the outcomes and recovery time for~     people who suffer with Achilles tendon pain.~   "
81553|NCT02499471|"~     Rationale: During the last decades, research in possible therapies for existing obesity and~     developmental factors causing obesity has explosively increased. Recently renewed interest~     aroused for a tissue playing a possible role in both development and therapy for obesity:~     brown adipose tissue (BAT).~      To define the relation between BAT and thyroid hormone, the investigators set up the~     following research protocol. In this protocol BAT activity will be determined in subjects~     that underwent thyroidectomy for well-differentiated thyroid carcinoma.~      Objective: To study the effect of thyroid hormone and thyroid-stimulating hormone on brown~     adipose tissue activity.~      Study design: Determine BAT activity after thyroidectomy in well-differentiated thyroid~     carcinoma patients.~      Study population: Patients that underwent thyroidectomy for well-differentiated thyroid~     carcinoma, male and female, aged 18-65 years.~      Intervention: FDG-PET-CT-imaging ([18F]fluorodeoxyglucose positron-emission-tomography~     computed-tomography) of BAT activity will be performed under cold stimulation twice.~      For patients clinically withdrawn from thyroid hormone suppletion, the first occasion will be~     in a hypothyroid state within 4-6 weeks after thyroidectomy and the second measurement will~     take place in a euthyroid state 4 months after the start of thyroid hormone treatment.~      For patients receiving recombinant-thyroid-stimulating-hormone injections, the first occasion~     will be shortly after the injection in a state of high thyroid-stimulating hormone levels.~     The second measurement will be in a euthyroid state 4 months after the injection.~      Main study parameters/endpoints: The main endpoint of this study is the effect of thyroid~     hormone and thyroid-stimulating hormone on BAT activity in kBq (kilobecquerel) and SUV~     (standard uptake value). Secondary endpoints are the effects of thyroid hormone and~     thyroid-stimulating hormone on energy metabolism, body core temperature, skin surface~     temperatures and skin perfusion.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: The absorbed radiation dose from the FDG PET-CT scan after administration of 74~     MBq (megabecquerel) of 18F-FDG is 2.8 mSv (miliSievert).~   "
81554|NCT02499458|"~     Circulating tumor cells (CTCs) have prognostic value in several tumor types, and increasing~     evidence suggests that molecular characterization of CTCs can serve as a liquid biopsy to~     understand and address treatment resistance. The goal of this proposal is to demonstrate that~     CTCs can be accurately enumerated and characterized in metastatic clear cell renal cancer~     (CCRC) and can serve as prognostic/predictive biomarkers to improve treatment. The challenge~     surrounding CTC analysis in CCRC is that most CTC technologies (including the clinical~     gold-standard CellSearch®) depend in epithelial markers such as EpCAM that are expressed at~     low or heterogeneous levels in CCRC. Members of the research team have developed a novel CTC~     microfluidic technology that can effectively detect CTCs that are completely undetectable by~     CellSearch® because of very low EpCAM expression, as well as allowing for CTC recovery for~     downstream molecular characterization. The goal of this proposal is therefore to test the~     hypotheses that (1) The microfluidics CTC technology will have better sensitivity/specificity~     relative to the CellSearch in metastatic CCRC; and (2) Enumeration of CTCs in metastatic CCRC~     patients (n=66) will have prognostic value, while molecular characterization of CTCs for~     expression of biomarkers (VHL, VEGF, mTOR, HIF1/HIF2, AKT) related to CCRC etiology will be~     predictive of response/resistance to targeted therapies. Although CCRC is relatively~     uncommon, the lack of established adjuvant treatments and high cost of targeted therapies in~     the palliative setting makes the search for new prognostic/predictive biomarkers an important~     clinical goal.~   "
81555|NCT02499445|"~     In patients undergoing off-pump coronary artery bypass (OPCAB) surgery with different~     anesthesia regimens: remifentanil (0.75 mcg/kg/min) and propofol (TCI effect-site~     concentration 0.8-1.5 mcg/ml) (Group -RP); remifentanil (0.75 mcg/kg/min) and sevoflurane~     (end-tidal 0.8 vol%) (Group-RS), or sevoflurane (end-tidal 1.2-2.8 vol%)-sufentanil (TCI~     effect site concentration 0.35-0.75 ng/ml) (Group-SS), intergroup difference in the level of~     Troponin I (c-TnI) and creatinine kinase subtype-MB is determined before surgery (control),~     during vascular graft harvesting (harvesting), after completing graft construction~     (postgrafting), and one day after surgery (postoperative).~   "
81556|NCT02499432|"~     To further increase the access of evidence based psychotherapies for Veterans with~     Posttraumatic Stress Disorder, we propose to offer training and intensive consultation to~     community-based providers in Cognitive Processing Therapy for Posttraumatic Stress Disorder.~     However, we believe that many clinicians may not implement Cognitive Processing Therapy or~     take advantage of consultation after initial training. For this reason, we propose to examine~     the effectiveness of an enhanced training method, which would add Motivational Interviewing~     to the standard Cognitive Processing Therapy training. Motivational Interviewing is a form of~     collaborative discussion for strengthening motivation and commitment to change. We~     hypothesize that augmenting the standard Cognitive Processing Therapy training with these~     techniques will reduce providers' reluctance to fully implement the interventions.~   "
81569|NCT02499263|"~     This is a prospective, single country, multi-center study in Ulcerative Colitis (UC) patients~     treated with adalimumab. 200 subjects will be enrolled at approximately 20 sites. The~     baseline assessment should be performed prior to the first dose of adalimumab (Visit1). Study~     visits will be conducted at weeks 8, 16, 24, 32, 40, 48 and 56 in accordance with clinical~     practice. All subjects will have one Follow-up for safety approximately 70 days after the~     last dose of adalimumab~   "
81570|NCT02499250|"~     The purpose is to test whether daily ischemic conditioning of the arms over 30 days could~     reduce the frequency and severity of angina pectoris and improve the life quality of~     refractory angina pectoris patients.~   "
81557|NCT02499419|"~     Mitral valve prolapse (MVP) is a relatively common cardial problem in which one or more of~     the leaflets of the mitral valve prolapse during systole into the left atrium.~      The disease is very heterogeneous and can vary from a benign disease with almost no impact on~     the patient's life to a severe cardiac problem with many complications and high mortality~     rate.~      The purpose of the study is to see if the investigators can find a relation between the~     severity of the MVP to the exercise capacity of the patient. The investigators also want to~     see if they can find a difference between the exercise capacity of mild MVP patients and~     healthy people.~      To evaluate the exercise capacity of the subjects the investigators use Cardiopulmonary~     Exercise Testing (CPET). CPET is probably the best known way to get a full picture of the~     subject's functions during exercise. By combining gas exchange monitoring and ECG during a~     controlled exercise in which the subject reaches maximal effort, the test gives information~     about the cardiac, the pulmonary and the metabolic functions of the subject. This information~     can help identify if there is a problem to perform exercise properly and more specifically if~     the limitation is due to a cardiac, pulmonary or metabolic problem.~   "
81558|NCT02499406|"~     Uncontrolled pilot study examines feasibility, acceptability, and preliminary efficacy of~     Dialectical Behavior Therapy skills group for Veterans with suicidal ideation and emotion~     dysregulation.~   "
81559|NCT02499393|"~     New 2010 neonatal resuscitation guidelines state that offering therapeutic hypothermia (TH)~     should be a standard of care in managing neonates with perinatal hypoxic - ischemic insult~     and present with signs of moderate and/or severe hypoxic - ischemic encephalopathy (HIE) .~     Despite the evidence from several randomized control trial (RCT) proving its effectiveness,~     its effect is perceived insufficient or only modest. Thus today's research efforts are~     directed toward finding the new possibilities of enhancing the effects of hypothermia. List~     of agents with potential neuroprotective properties includes: erythropoetin, melatonin,~     topiramate, morphine, xenon, MgSO4. Given investigators previous experiences with preterm~     neonates exposed to MgSO4 prenatally or administered this drug after birth because of~     perinatal asphyxia, the investigators designed the trial which would evaluate the possibility~     of increasing the TH effect by combining this method with MgSO4. Until now there are several~     published studies evaluating the effectiveness of MgSO4 in the group of asphyxiated neonates,~     including one RCT. However, all of these studies were conducted before the era of TH~     Furthermore, irrespective of the potential benefits, safety of using MgSO4 during TH in the~     group of term neonates was not studied. It is particularly important in the light of the~     results presented by Mittendorf et.al. They studied the effects of prenatal aggressive~     treatment with MgSO4 on the outcome of preterm neonates showed that patients exposed to high~     doses of MgSO4 were at higher risk of severe intracranial bleeding. Other side effects of~     high serum magnesium levels are: vasodilatation, hypotension, cardiac arrhythmias,~     coagulopathy, and gastrointestinal disturbances. MgSO4 is a very attractive neuroprotective~     option,also because of its easy availability. Drug can be administered in the birth hospital~     while neonate is being prepared for the transport to TH center. Timing of the intervention is~     very important for neonates suffering from perinatal asphyxia. Both TH and administration of~     potentially neuroprotective drug should be started during therapeutic window. It is the~     initial potentially reversible phase of hypoxic insult lasting about 6 hours. If the~     long-term follow up shows that MgSO4 has an additive neuroprotective effect and no~     significant side effects in the group of asphyxiated neonates treated with TH this relatively~     simple and not expensive intervention may be introduced into clinical practice~   "
81560|NCT02499380|"~     The objective of this post-marketing study is to advance the understanding of the mechanism~     of action of the CE marked RePneu Coil by observing changes in lung physiology and cardiac~     performance in patients with emphysema treated with the RePneu Coils, when used as intended.~   "
81561|NCT02499367|"~     This is a single center non-blinded randomized non-comparative phase II trial. The first~     stage of the trial consists of five arms ( with induction treatment followed by nivolumab, 1~     with no induction treatment before nivolumab).~      For the second stage, the number of arms will be reduced based on the results obtained in the~     first stage.~   "
81562|NCT02499354|"~     The purpose of the study is to determine the relative effect size of standard IV and oral~     iron treatment of RLS with Iron deficiency anemia (IDA) and to determine the time course of~     treatment response.~   "
81563|NCT02499341|"~     The purpose of the study is the comparison between ketamine and tramadol, regarding the~     analgesia quality and efficiency, in patients receiving Patient Controlled Analgesia (PCA)~     morphine, after major upper abdominal surgeries such as hepatectomies, gastrectomies, Whipple~     procedures and peripheral pancreatectomies. The goal is to bring out an improved analgesia~     scheme, which can be applied to the clinical work and refine the analgesia provided for major~     procedures which require increased postoperative opioids doses. In the study, half of~     patients will receive continuous intravenous infusion of tramadol and Patient Controlled~     Analgesia morphine and the other half will receive continuous intravenous infusion of~     ketamine and Patient Controlled Analgesia morphine postoperatively after major upper~     abdominal surgery. The successful combination of different drugs targets at the improvement~     of the analgesia provided, the reduction of complications and the exploitation of the~     pharmacodynamic properties of each drug.~   "
81564|NCT02499328|"~     This multicentre, open-label, Phase 1b/2 study is designed as a 2 part study consisting of a~     dose-escalation, safety run-in Part A and a dose-expansion Part B~   "
81565|NCT02499315|"~     The purpose of the study is to find out if AMG 357 is safe and tolerated by women with~     Rhematoid Arthritis.~   "
81566|NCT02499302|"~     The general aim of this study is to investigate the effect of an individually tailored mental~     training program in adolescents developing chronic fatigue syndrome (CFS) after an acute~     Epstein Barr-virus (EBV) infection. Endpoints include physical activity (primary endpoint),~     symptoms (fatigue, pain, insomnia), cognitive function (executive functions) and markers of~     disease mechanisms (autonomic, endocrine, and immune responses).~   "
81567|NCT02499289|"~     Polycystic ovary syndrome (PCOS) has a heterogeneous clinical presentation comprising~     reproductive (hyperandrogenism, menstrual irregularity, anovulation, infertility, pregnancy~     complications), metabolic [insulin resistance (IR), increased type 2 diabetes mellitus (T2DM)~     and cardiovascular disease (CVD) risk factors] and psychological features (worsened quality~     of life and increased anxiety and depression) Whether prolonged fasting during Ramadan breaks~     the insulin resistance state of polycystic ovarian syndrome and subsequently improve the~     ovulation and spontaneous pregnancy will happen without ovarian stimulation.~   "
81568|NCT02499276|"~     Experimental animal data suggest that increasing breathing pattern variability in mechanical~     ventilation could be beneficial. Variable ventilation can be induced through the following~     modes: Neurally Adjust Ventilatory Assist (NAVA), Proportional Assist Ventilation (PAV) and~     Variable-Pressure Support Ventilation (V-PSV). These modes have not yet been compared to each~     other. Pilot observations in our department suggest a feasibility in patients.~      The objectives of the study are to compare the impact of PSV, NAVA, PAV and V-PSV on the~     variability of the breathing pattern, patient-ventilator asynchrony, risk of lung~     overdistension, gas exchange, and repartition of ventilation.~   "
81573|NCT02499211|"~     Using a cluster randomized controlled design, this study will evaluate effects of in-store~     healthy food marketing strategies on sales and purchase of specific healthier items in six~     product categories (milk, frozen entrees, beverage checkout coolers, salty snacks, bread and~     cheese); and examine the effects of changes in in-store food marketing environments on sales~     of healthier foods. If these strategies are found to be effective, they could be used widely~     to encourage healthy retail sales, complement food access initiatives, and reduce health~     disparities in obesity and other diseases. Supermarkets will be the unit of randomization,~     intervention, and analysis.~   "
81574|NCT02499198|"~     Smokeless tobacco users who are unable or unwilling to quit tobacco use may be exposed to the~     potent oral and esophageal carcinogen NNN not only from tobacco itself, but also via its~     endogenous synthesis from nornicotine. The proposed study will lead to an understanding of~     the endogenous formation of NNN from nornicotine in humans, and will also investigate the~     effect of the reduction of nornicotine content in smokeless tobacco on the extent of~     endogenous NNN formation. The knowledge gained in this study will lead to the development of~     recommendations for the regulation, or potentially elimination, of nornicotine in smokeless~     tobacco products in order to minimize exposure to NNN in the users of these products.~   "
81575|NCT02499185|"~     To validate the use of [TIMP-2]●[IGFBP-7] to predict AKI in patients undergoing major intra~     abdominal surgery.~   "
81576|NCT02499172|"~     This study, to be carried out immediately following an emergency, reactive cholera~     vaccination campaign in Nsanje District, Malawi, will be a cohort study to estimate the~     safety of killed oral cholera vaccine (OCV), in pregnant women as measured by ShancholTM, on~     pregnancy outcomes and birth defects. While limited evidence which suggests that the vaccine~     is safe in pregnant women, this setting will allow investigators to answer this question in a~     community where more than 100,000 people will receive vaccine with no restrictions on~     pregnancy status. In past cholera vaccine campaigns including clinical trials, pregnant women~     were excluded due to lack of safety data. However, in this campaign, the decision by the~     Ministry of Health is that the benefits of offering vaccine to all individuals regardless of~     pregnancy status far outweigh any theoretical risk. Here the investigators specifically~     propose to:~      Specific Objective 1: To conduct surveillance of pregnant women to detect adverse pregnancy~     outcomes within communities in Nsanje District, Malawi that received oral cholera vaccine in~     a reactive vaccination campaign that started on 30 March 2015. Through household surveying~     and enrollment of pregnant women with monthly follow-up visits, the investigators will~     determine the cumulative incidence of adverse pregnancy outcomes among vaccinated and~     unvaccinated women in Nsanje and Chikwawa Districts, Malawi.~      Specific Objective 2: To compare the cumulative incidence of pregnancy loss (miscarriage and~     stillbirth) of women who received oral cholera vaccine while they were pregnant to women who~     were vaccinated and became pregnant after the end of the final round of vaccination in Nsanje~     and Chikwawa Districts, Malawi.~      Specific Objective 3: To compare the incidence of newborn malformations in a cohort of~     infants that had fetal exposure to oral cholera vaccine compared to those without such~     exposure in Nsanje and Chikwawa Districts, Malawi.~   "
81577|NCT02499159|"~     This study is looking to evaluate the efficacy of liposomal bupivicaine (Exparel) on~     decreasing the amount of consumed pain medications.~      Patients will be randomly selected to received either Exparel or standard bupivicaine~     injection during surgery. Patients will be followed up to assess pain levels using a visual~     pain scale, and to assess how much pain medication was consumed.~   "
81578|NCT02499146|"~     As part of the global clinical development program for Palbociclib, studies are planned in~     cancer patients in China. An assessment of Palbociclib pharmacokinetics in Chinese patients,~     as required by the Chinese Health Authorities, is therefore warranted. In addition, safety~     and efficacy will be also evaluated.~      The single and multiple 125 mg oral dose pharmacokinetics of Palbociclib will be~     characterized.~   "
81579|NCT02499133|"~     Researches that focus on the perception of prosodic elements among adult who suffered~     traumatic brain injury (TBI), focus on their ability to decipher intonation in order to~     understand an additional meaning of a sentence. According to these researches, adults who~     suffer from TBI, with no signs of Aphasia, have difficulty perceiving and deciphering~     intonation (Marquardt et al., 2001; Angeleri et al., 2008). The current research asks to~     broaden the knowledge in this domain by examining the ability of adults with TBI to~     understand an additional prosodic element - focused stress.~      The ability to identify and understand focused stress in a sentence requires different~     abilities. First, a psychoacoustic ability in order to detect the stressed word. Second, an~     ability to understand the lexical grammatical meaning of the word as it negates other~     possible meanings (for example, in the sentence I'm eating a red apple the stressed word~     negated the option of a different color). Third, an understanding of the stressed word as it~     creates a different pragmatic/social meaning (for example, in the sentence mom, I asked for~     red, yellow and green candy the role of the stressed word is to mark the candy that the~     addressee didn't get).~      The aim of the study is to assess the ability of adults who had experienced TBI to grasp and~     understand the meaning of focused stress in the different contexts that were described above.~     An additional aim is to examine if differences in speech and cognitive abilities can describe~     some of the variation in the results.~      Thirty adults between the ages of 18-50 years will take part in this study, fifteen adults~     who had experienced moderate to severe TBI (0.5-3 years post injury) and fifteen healthy~     adults. Each participant with TBI will be matched to a healthy adult by gender, age,~     education and social-economic status. All of the participants will be Hebrew native speakers,~     with no learning disability, no neurological injury, proper speech abilities and no hearing~     impairment.~      The participants will undergo seven different tests in three different meetings (60 minute~     each), in a quiet room at Sheba - Academic Medical Center Hospital. The tests will include~     different cognitive and language examinations. The main test of the study will be The Hebrew~     Focused Stress Test (HFST). The HFST includes three subtests. The first subtest requires~     identification of the stressed word in a sentence based on psychoacoustic abilities alone.~     The second and the third subtests require understanding the meaning of focused stress in~     different contexts - lexical grammatical and pragmatic/social. The test includes forty eight~     recorded sentences. In each sentence one word is stressed. The participants will be asked to~     listen to the recordings and answer a closed question regarding the stressed word.~   "
81580|NCT02499120|"~     The purpose of this study is to determine whether the combination of palbociclib with~     cetuximab is superior to cetuximab in prolonging overall survival in HPV-negative,~     cetuximab-naive patients with recurrent/metastatic squamous cell carcinoma of the head and~     neck.~   "
81581|NCT02499107|"~     This study will compare the effects of commonly consumed carbohydrate sources such as~     potatoes, pasta and rice along with a fixed portion of meat on blood glucose, satiety and~     insulin levels among healthy body weight children. Healthy boys and girls, aged between 11 -~     13 years old, will be involved in this study.~   "
81582|NCT02499094|"~     The purpose of this study is to validate the effectiveness of using an integrated mobile~     sensing platform to deliver large-scale data-driven interventions to patients with~     depression.~   "
81583|NCT02499081|"~     The purpose of this study is to evaluate the effect of Ixazomib on inducing osteoblast~     activation as measured by bone markers and imaging in patients with relapsed/refractory~     myeloma.~   "
81584|NCT02499068|"~     The purpose of the study is to verify the clinical effectiveness of a managed home~     telemonitoring program in patients with severe COPD against usual clinical practice, as~     measured by the decrease in the number of exacerbations, number of hospitalizations, hospital~     days and emergency room visits in a 12 month period~      The primary endpoint of effectiveness is severe exacerbations avoided.~      The main hypothesis is that patients with severe or very severe COPD patients managed with a~     home telehealth program have better outcomes than patients managed according to usual~     clinical practice.~   "
81664|NCT02498028|"~     The aim of this study is to examine the clinical outcome after anterior cervical~     decompression and fusion, and cervical disc prostheses in general. Additionally these two~     surgical methods for degenerative diseases of the cercival spine are analyzed comparatively~     in order to see whether one procedure should be preferred.~   "
81585|NCT02499055|"~     Background. In Denmark, about 350,000 persons suffer from anxiety. Public health-care~     services plan to implement internet based self-help psychotherapy (IBT) to be an important~     alternative and supplement to ordinary face-to-face therapy. Meta-analyses indicate that the~     effect of IBT for anxiety disorders seems better than no intervention, and in some instances~     equal to 'usual therapy'. But studies have been characterised by small sample sizes, high~     risk for bias, including high dropout.~      Objective. The objective of this pilot trial is to assess the feasibility of conducting a~     larger confirmatory trial investigating the benefits and harms of an internet-based self-help~     therapy program, FearFighter™, compared with no intervention for persons with an anxiety~     disorder.~      Design. An investigator-initiated feasibility randomised clinical trial investigating~     internet-based therapy with FearFighter™ compared with no intervention for persons with an~     anxiety disorder. We will include 64 participants.~      Eligibility criteria. Inclusion criteria: age 18 or older; specific phobia, panic disorder,~     agoraphobia, or social phobia is the primary diagnosis according to the DSM-IV; and informed~     consent. Exclusion criteria: suicidal risk; ongoing episode of bipolar disorder or psychosis;~     concurrent psychological treatment for the anxiety disorder; unable to attend the~     intervention; or lack of informed consent.~      Intervention. The intervention group will use the program FearFighter™, a nine session~     cognitive behavioural self-help therapy program delivered over the internet during nine~     weeks. The control group receive no intervention for nine weeks.~      Outcomes. Feasibility outcomes are the fraction that are eligible, the fraction that are~     randomised, and the compliance in the intervention group. Clinical exploratory outcomes are:~     remission, Beck Anxiety Inventory, Symptom Check List-90R, WHO Well-Being Index, Sheehan~     Disability Scale, serious adverse events, and behaviour log from FearFighter.~      Time schedule. Participants will be included in the trial from July 2015. Results are~     expected in February 2016.~   "
81586|NCT02499042|"~     This Phase 2 study aims to determine the feasibility of paramedic titration of oxygen~     delivery in adult patients who have been resuscitated from OHCA.~   "
81587|NCT02499029|"~     Examine the effects of N-acetylcysteine on PTSD symptoms, craving and substance use in~     veterans with PTSD and comorbid substance use disorders.~   "
81588|NCT02499016|"~     Conventional laparoscopic appendectomy(CLA) is the current standard treatment. To obtain~     additional benefits such as a better cosmetic outcome, the investigators developed a surgical~     option termed suprapubic single-incision laparoscopic appendectomy (SSILA), which creates a~     non-visible scar, that was preliminarily shown to be feasible and safe in our previous~     retrospective studies To further evaluate the feasibility, safety and cosmetic results of~     this innovative approach, the investigators compared the outcomes of SSILA and CLA by~     performing a randomized controlled trial.~   "
81589|NCT02499003|"~     The purpose of this study is to evaluate the overall response rate of Obinutuzumab (GA101) in~     combination with Pixantrone in patients with relapsed aggressive B-cell lymphoma. 70 patients~     with diffuse large B-cell lymphoma, follicular lymphoma grade IIIB or transformed indolent~     lymphoma will receive up to 6 cycles of the described combination regimen. Follow up visits~     are scheduled for up to 3 years.~   "
81590|NCT02498990|"~     The primary hypothesis is to investigate whether a low calorie diet for 7 weeks followed by~     continuous lifestyle advice is an effective option to achieve an improvement in glucose~     control as measured by HbA1c after 52 and 104 weeks as compared to baseline values in obese~     type 2 diabetes patients on either tablet or insulin treatment. The secondary hypothesis is~     to investigate whether the weight reduction therapy also has significant impact on various~     anthropometric, clinical and metabolic parameters associated with obesity.~   "
81591|NCT02498977|"~     LIFT is prospective randomised marker-based trial to assess the clinical utility and safety~     of biomarker-guided immunosuppression withdrawal in liver transplantation. 'LIFT' aims to~     validate a biomarker test of operational tolerance to stratify liver transplant recipients~     before withdrawing immunosuppressive medication. Primary objective is clinical utility and~     risk/benefit ratio of employing a transcriptional test of tolerance to stratify liver~     recipients prior to immunosuppression withdrawal. Secondary objectives are: safety of~     biomarker-guided immunosuppression withdrawal; health-economic and quality of life impact of~     biomarker-guided immunosuppression withdrawal; improvement in drug-related co-morbidities;~     prevalence of tolerance over time; role of donor-specific anti-human leukocyte antigen (HLA)~     antibodies; identify mechanisms of liver allograft tolerance. It is a prospective,~     multi-centre, phase IV, biomarker-strategy design trial with a randomized control group in~     which adult liver transplant recipients will undergo immunosuppression withdrawal. The sample~     size is 148 patients.~   "
81592|NCT02498964|"~     High fidelity simulations provide a unique opportunity for teaching and evaluation of~     knowledge, clinical reasoning, decision making and teamwork. We have developed a series of~     novel cardiac based simulations that review difficult learning objectives of cardiac~     anesthesiology rotation. We hypothesized that residents who have completed a rotation in~     cardiac anesthesiology will perceive these simulations to be both mentally challenging and a~     useful tool in preparing them for their subsequent clinical experience and for their~     anesthesiology board. For the first time, we have used the NASA Task Load Index Scale in~     evaluating Neuro Cognitive Workload during Cardiac Anesthesia Based simulation scenarios~     .Residents who have completed the cardiac rotation at least once would be assigned the task~     in small groups either a group of 2 or group of 3.The module consists of 3 different~     scenarios. The scenarios include, weaning the patient off of cardio pulmonary bypass,~     management of severe protamine drug reaction and acute hypotension from malfunction of the~     coronary graft in a simulated operating room in real time.~        1. Setting up a Simulation Lab,almost similar to real cardiac operating rooms would have~          cardio-pulmonary bypass machine,transesophageal echocardiography images upon request,all~          emergency medications with various infusions pumps,defibrillator,real time monitors~          include EKG,SpO2,invasive arterial line,CVP,PAP,ETCO2,operating room surgical~          equipment,anesthesia machine with ventilator.~        2. Tasks Assigned to the residents~        3. Feed-back and Teaching Session~        4. At the end of each session residents are encouraged to reflect upon how they performed~          and learning gaps that they perceived and areas that they felt needed to improve upon.~        5. Feedback session would be followed by interactive teaching to reinforce the knowledge.~        6. Evaluation of Hypothesis using NASA TLX Scale. Immediately following the Simulation~          based training, residents would be given the paper based NASA TLX scale to assess the~          neurocognitive workload~   "
81593|NCT02498951|"~     This randomized phase II trial studies how well obinutuzumab works as maintenance treatment~     in patients with central nervous system lymphoma who have achieved the disappearance of all~     signs of cancer in response to treatment (complete response). Monoclonal antibodies, such as~     obinutuzumab, may kill cancer cells that are left after chemotherapy.~   "
81594|NCT02498938|"~     Chronic obstructive pulmonary disease and periodontitis are chronic inflammatory diseases.~     The study aims to determine if the genetic polymorphism of SERPINA1 gene in patients with~     COPD serve as a risk factor for developing periodontitis.~   "
81628|NCT02498496|"~     The purpose of this study is to assess whether administration of a bolus dose of MgSO4~     (magnesium sulfate) plus standard therapy is superior to standard therapy alone for the~     management of Acute Exacerbations of Chronic Pulmonary Obstructive Disease (AECOPD) in the~     emergency department. The investigators hypothesize that MgSO4 causes faster recovery of the~     bronchospasm, and a reduction of the dead space, translating to the following clinical~     outcomes : less hospitalisation, lower length of stay (LOS), better composite outcome of~     hospitalisation + LOS + readmission for AECOPD.~   "
81595|NCT02498925|"~     The prevalence of major depressive disorder (MDD) is relatively low in childhood (i.e.,~     1-3%), but increases substantially during adolescence. By the age of 18, approximately 15% of~     adolescents will have experienced at least one episode of MDD. A growing body of research~     implicates abnormalities in reward circuitry as playing a critical role in the development~     and maintenance of depressive symptoms in adolescents. Importantly, these reward-circuitry~     abnormalities have been linked to anhedonia (i.e., decreased pleasure or blunted reactivity~     to rewarding stimuli). Behavioral Activation (BA) represents a promising - and relatively~     simple to deliver - nonpharmacologic intervention for adolescent depression, which has been~     shown to be at least as effective as Cognitive Behavioral Therapy (CBT) with regards to~     symptom reduction and lowering the risk of relapse in adult samples. More recently, promising~     data have emerged from the application of BA to depressed adolescents. BA can be~     conceptualized as a treatment directly targeting anhedonia. More specifically, BA targets~     anhedonia through behavioral change strategies aimed at gradually increasing patients'~     exposure to and engagement with rewarding stimuli and positively reinforcing experiences.~     Given this treatment focus, BA may be particularly beneficial for adolescents struggling with~     relatively elevated levels of anhedonic symptoms. Accordingly, the present study will examine~     the role of anhedonia and reward functioning in predicting treatment response in BA. In~     addition, analyses will be conducted examining the reward-related neural and behavioral~     mechanisms underlying anhedonic symptom improvement in BA.~   "
81596|NCT02498912|"~     The purpose of this phase I study is to test the safety of different dose levels of specially~     prepared cells collected called modified T cells. In the screening part of this study the~     tumor was found to have a protein called MUC16. This protein is present on about 70% of~     ovarian cancers. The investigators want to find a safe dose of modified T cells for patients~     with this type of cancer that has progressed after standard chemotherapy. We also want to~     find out what effects these modified T cells have on the patient and their cancer.~   "
81597|NCT02498899|"~     The goal of this research study is to learn how patients view their doctor's compassion about~     supportive care and treatment options for advanced cancer patients.~   "
81598|NCT02498886|"~     At MRC Human Nutrition Research, the investigators have developed an engineered analogue of~     the ferritin-core for safe and effective iron supplementation. Iron hydroxide adipate~     tartrate (IHAT) is a tartrate-modified, nano-disperse Fe(III) oxo-hydroxide, formed in an~     adipate buffer, with similar functional properties and small primary particle size (~2 nm) as~     the iron found in the ferritin core; it better mimics iron absorption from food than the~     non-physiological bolus doses of ferrous sulphate currently used.~      This exploratory study will test the hypothesis that IHAT has equivalent bioavailability to~     ferrous sulphate but produces a less harmful post-ingestion rise in transferrin saturation.~     The design is a 3-arm (IDA, non-IDA and IDA-IHAT new manufacture), crossover, randomised,~     single-dose study.~      Primary endpoint:~      Relative bioavailability value of IHAT versus ferrous sulphate. This will be determined from~     the red blood cell incorporation of isotope-labelled iron 14 days following a single oral~     dose.~      Secondary endpoints:~      Serum iron at 0, 2, 4, 6 hours following a single dose of each iron compound. Transferrin~     saturation at 0, 2, 4, 6 hours following a single dose of each iron compound.~      Plasma 58Fe and 57Fe at 0, 2, 4, 6 hours. Pathogen growth using ex vivo assays in serum~     collected from each subject at 0, 2, 4 and 6 hours following a single dose.~   "
81599|NCT02498873|"~     In a competitive scenario, trainers and coaches seek to improve the performance of their~     athletes organizing macrocycles (year), mesocycles (months), and microcycles (weeks) training~     aimed at a specific moment of a competition. The organization variables, mainly the intensity~     of exercise in a training routine can stimulate important physiological pathways and uphold~     superior gains to VO2max, leading to a peak aerobic performance. However, due to lack of~     evidence, and the difficulty of control on a large scale, the effects of the intensity~     organization over a mesocycle periodization are still poorly investigated.~   "
81600|NCT02498860|"~     Two-Year Disease Free Survival Rate of Stage IB~IIIA adenocarcinoma after Adjuvant~     Chemotherapy with Pemetrexed and Cisplatin will be assessed. A total of 106 patients will be~     recruited for 12 months, and followed for two years, thus the duration of study will be 36~     months.~   "
81601|NCT02498847|"~     Knee osteoarthritis (OA) affects 27 million US adults and is a leading cause of pain and~     disability. Non-pharmacological interventions are recommended but are underutilized. Exercise~     reduces pain and improves physical function, but benefits tend to wane without a component to~     facilitate behavior change. Cognitive behavioral therapy (CBT) has long term benefits on pain~     and physical function in individuals with OA, but is not typically offered in clinical care.~     CBT could be taught in the context of clinical care by occupational therapists (OT). OTs help~     people manage chronic conditions by teaching behavioral strategies that promote health and~     function. The purpose of this study is to test the feasibility and efficacy of an~     OT-delivered cognitive behavioral therapy program to help people manage their knee OA.~   "
81602|NCT02498834|"~     The purpose of this study is to conduct a randomized controlled trial with English and~     Spanish-speaking adolescents to compare the effectiveness of an adolescent asthma question~     prompt list with a supportive educational video intervention with usual care.~      The hypothesis of this study is that by showing the parents and adolescents the educational~     video and then providing the adolescents with the one-page asthma question prompt lists to~     use during their visits will improve: (a) asthma control, (b) adolescent self-efficacy in~     managing asthma, and (c) adolescent quality-of-life.~   "
81603|NCT02498821|"~     The purpose of the study is to evaluate differences in the time and costs between Sherlock~     3CG® TCS and Chest X-ray to confirm the location of a Peripherally Inserted Central Catheter~     (PICC).~   "
81649|NCT02498223|"~     In order to reduce the physiological and biomechanical loads that the soldiers are exposed~     to, the investigators want to examine new approaches for distributing the carried loads~     according to measurements that are specific for each soldier (body composition and aerobic~     capacity). A functional index (LCI=load carriage index) will provide the commander a tool for~     better decisions in distributing the same total load among the same number of soldiers,~     according to each soldier's ability.~   "
82804|NCT02483104|"~     This is a Phase 1, open-label, multicenter, dose escalation study evaluating the~     tolerability, safety, pharmacokinetics and preliminary efficacy of veliparib in combination~     with carboplatin and weekly paclitaxel in Japanese subjects with ovarian cancer.~   "
81604|NCT02498808|"~     Neutrophils emerge as key immune cells in the initiation and perpetuation of immune responses~     in autoimmune diseases. They display marked abnormalities in phenotype and function in~     various autoimmune diseases, including systemic vasculitis, systemic lupus erythematosus~     (SLE) and rheumatoid arthritis (RA).~      These neutrophils are characterised by an extended life span, increased capacity to produce~     reactive oxygen species, active gene expression and release of extracellular traps.~     Consequently, there is a need for better understanding of neutrophil phenotype and functions~     in these conditions, as well as for identifying molecules capable of specifically~     manipulating neutrophil function. The investigators have recently discovered that interferon~     lambdas (IFN-λs), also known as interleukin 28 (IL28) and interleukin 29 (IL29), class II~     cytokines with previously studied anti-viral biological functions, specifically suppress~     neutrophil infiltration and interleukin-1β production and thereby, halt and reverse the~     development of collagen induced arthritis (CIA). The investigators propose to further~     investigate the cellular and molecular mechanisms behind this suppression and examine the~     translational potential of the investigators' finding by examining the IFN-λ receptor~     expression and function in neutrophils isolated from the blood of healthy donors and~     rheumatic patients (early rheumatoid arthritis and vasculitis).~   "
81605|NCT02498795|"~     The accomplishment of a treatment with Intratissue Percutaneous Electrolysis of additional~     form to the accomplishment of eccentric exercise's program in patients with chronic patellar~     tendinopathy is more effective than the accomplishment of an additional treatment with dry~     needling or eccentric exercise's program realized of isolated form.~   "
81606|NCT02498782|"~     The hypothesis is to evaluate if the treatment with Fexinidazole will lead to a better~     sustained clearance of the parasites at 6 months of follow-up when in comparison to placebo~     in patients with chronic indeterminate CD.~   "
81607|NCT02498769|"~     In this study, the investigators aim to determine whether injecting botulinum toxin into~     epicardial fat pads is efficacious and safe for decreasing postoperative atrial fibrillation~     (POAF) after cardiac surgery. The investigators will test the hypothesis that botulinum toxin~     injected into the epicardial fat pads reduces POAF and length of stay (LOS) without~     increasing adverse events. This will be a prospective randomized trial of 130 patients~     undergoing coronary artery bypass graft (CABG), valve surgery or CABG + valve surgery with~     cardiopulmonary bypass. Patients will be randomized to receive either botulinum toxin (50~     units per fat pad, n=65) or normal saline/placebo (1 mL per fat pad, n=65) injected into~     epicardial fat pads. All patients will receive standardized anesthetic, surgical, and~     post-surgical care. The primary outcome in this study will be time to occurrence of~     in-hospital POAF. Based on previous work and a pilot trial showing a pronounced reduction~     (relative risk reduction 77%) in POAF after injecting botulinum into the epicardial fat pads,~     the investigators anticipate a significant reduction in the risk for POAF with epicardial~     botulinum in this cohort, which includes valve surgery patients.~   "
81608|NCT02498756|"~     For investigators' current experimental clinical trial, patients are given 4 injections of~     ipilimumab, given 3 weeks apart x 4 injections with or without cytokine-induced killer~     therapy. Investigators propose to test this dual therapy in patients with melanoma who have~     known stage I, metastatic melanoma. Investigators hypothesize that this form of combinatorial~     immunotherapy will result in tumor stabilization or shrinkage, significant prolongation of~     progression-free, disease-free or overall survival compared to the use of ipilimumab alone~   "
81609|NCT02498743|"~     The objective of this study is analyze the influence of TV entertainment in children less~     than 3 years of age during echocardiography in order to achieve a complete and accurate test.~      This is an experimental study in children with suspected congenital or acquired cardiac~     disease. An examination room was prepared with a TV on the ceiling that was positioned in a~     way that would provide unobstructed viewing for children during the echocardiography~     procedure.~   "
81610|NCT02498730|"~     Our main objective will be to evaluate the chronic effects (12 weeks) of high-intensity~     interval training compared to moderate intensity (same total work) on reducing the symptoms~     of bipolar disorder, cortical changes, as well as on the VO2max. In addition, the~     investigators will establish what influence of gain to VO2max has on reducing symptoms.~   "
81611|NCT02498717|"~     This study will examine the initial efficacy and cost-effectiveness of using the~     cryocompression therapy model both pre-operatively and post-operatively in patients that have~     recently suffered a traumatic calcaneus or ankle fracture compared to the standard~     pre-operative RICE therapy procedures.~   "
81612|NCT02498704|"~     The purposes of this double-blinded, randomized controlled trial are (1) to determine if the~     addition of trigger point dry needling (TDN) to a standard stretching program results in~     greater improvements in hamstring flexibility versus stretching alone in a population with~     atraumatic knee pain; (2) measure length of time that flexibility gains are maintained, (3)~     assess resulting movement mechanics and (4) assess patient reported changes in pain. Findings~     will potentially lead to insights as to the benefit of applying this intervention to~     additional body regions.~   "
81613|NCT02498691|"~     Endometriosis is a benign gynecological disease, characterized by the presence of~     endometrium-like tissue outside the uterine cavity that affect up to 10-15% of women in~     reproductive age worldwide, with an extensive impact on women's wellbeing and their~     reproductive life. Endometriosis lesions are heterogeneous and three phenotypes of the~     disease are well recognized and are fundamentally different from each other: superficial~     peritoneal endometriosis (peritoneal implants), ovarian endometrioma (cyst ovarian~     endometriosis), and deeply infiltrating endometriosis (invasive nodules greater than 5 mm).~      The investigators performed a prospective multicenter comparative study to assess the~     maternal and fetal risks related to endometriosis during pregnancy, regarding disease~     phenotype, This study will evaluate with sufficient power the risk of prematurity and~     obstetrical complications associated with endometriosis according to disease phenotype.~      This study aims to provide new informations to pregnant women with endometriosis, guide the~     monitoring of pregnancy, optimize management strategies based on the nature of complications~     and ultimately to improve the health of women and their unborn child~   "
81614|NCT02498678|"~     The objective of this study is to assess the performance of acceleromyography as a method of~     evaluation of muscle relaxation after application of tetanus stimulation to obtain stability~     of responses before administration of neuromuscular blocking agents.~   "
81615|NCT02498665|"~     This is a multicenter, open label, Phase 1 dose-escalation study of DSP-7888 Dosing Emulsion~     administered to adult patients with advanced malignancies. Patients will be administered~     escalating doses of DSP-7888 Dosing Emulsion intradermally or subcutaneously in accordance~     with the following regimen: once weekly for four weeks during the Induction Phase, once every~     7 to 14 days for 6 weeks during the Consolidation Phase, and once every 14 to 28 days until a~     discontinuation criterion is met during the Maintenance Phase. Once RP2D is determined from~     either the intradermal or subcutaneous group, an additional 40 patients evaluable for~     response may be enrolled as an expansion cohort at this dose and route of administration to~     confirm safety and tolerability. Separate from the dose-ascending cohort and RP2D expansion~     cohort described previously, and once the intradermal dose-ascending cohort is completed, up~     to 20 MDS patients who are refractory to treatment with hypomethylating agents (HMAs) will be~     enrolled into an MDS expansion cohort. Of these 20 MDS patients, one-half will receive~     DSP-7888 at 10.5 mg according to the modified schedule employed in Phase 1 (every week for 4~     weeks, every 2 weeks until Week 24, and then every 4 weeks; [MDS Cohort 1]). The other half~     of the MDS patients will receive DSP-7888 at 10.5 mg in an alternative dosing schedule where~     DSP-7888 is administered every 2 weeks until Week 24, after which it will be administered~     every 4 weeks (MDS Cohort 2).~   "
81616|NCT02498652|"~     This is a Phase 2a, randomized, open-label, multicenter study to assess the pharmacodynamic~     (PD) effects of RDEA3170 administered in combination with allopurinol compared with~     allopurinol administered alone in adult subjects with gout.~   "
81617|NCT02498639|"~     Pilot interventional study, without drug, randomized 1: 1, open-label comparison of efficacy~     and safety between the technique of percutaneous balloon aortic valvuloplasty without rapid~     ventricular pacing vs valvuloplasty during rapid ventricular pacing (using a temporary~     pacemaker device with CE mark). It is expected to enroll 100 patients. Randomization is done~     through a dedicated computer program.~   "
81618|NCT02498626|"~     This study was designed to examine if venous saturations from the central venous line and~     from the venous side of the heart lung machine are interchangeable or not with mixed venous~     saturation from the pulmonary artery in children undergoing open heart surgery for correction~     of various congenital heart defects.~   "
81619|NCT02498613|"~     This phase II trial studies cediranib maleate in combination with olaparib in treating~     patients with solid tumors that have spread to other parts of the body or cannot be removed~     by surgery, including breast cancer, non-small cell lung cancer, small cell lung cancer, and~     pancreatic cancer. Cediranib maleate and olaparib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Cediranib maleate may also block the~     flow of oxygen to the tumor, and may help make the tumor more sensitive to olaparib.~   "
81620|NCT02498600|"~     This randomized phase II trial studies how well nivolumab works with or without ipilimumab in~     treating patients with epithelial ovarian, primary peritoneal, or fallopian tube cancer that~     has not responded after prior treatment (persistent) or has come back (recurrent). Monoclonal~     antibodies, such as nivolumab and ipilimumab, may block tumor growth in different ways by~     targeting certain cells.~   "
81621|NCT02498587|"~     This is a multi-centre, prospective, short period incidence observational study of patients~     in participating hospitals and intensive care units (ICUs) with SARI. The study period will~     occur, in both Northern and Southern hemispheric winters. The study period will comprise a 5~     to 7-day cohort study in which patients meeting a SARI case-definition, who are newly~     admitted to the hospitals / ICUs at participating sites, will be included in the study. The~     study will be conducted in 20 to 40-hospital/ ICU-based research networks globally. All~     clinical information and sample data will only be recorded if taken as part of the routine~     clinical practice at each site and only fully anonymised and de-identified data will be~     submitted centrally.~      The primary aim of this study is to establishing a research response capability for a future~     epidemic / pandemic through a global SARI observational study. The secondary aim of this~     study is to investigate the descriptive epidemiology and microbiology profiles of patients~     with SARI. The tertiary aim of this study is to assess the Ethics, Administrative, Regulatory~     and Logistic (EARL) barriers to conducting pandemic research on a global level.~   "
81622|NCT02498574|"~     A promising form of enhancing brain function non-invasively involves stimulating the brain~     using weak magnetic or electric currents. This method is becoming increasingly popular in~     both clinical and commercial circles; a number of portable, at-home devices are available on~     the commercial market for personal use. In this study, the investigators aim to determine~     factors associated with the enhancement of cognitive and motor learning following~     transcranial direct-current stimulation in healthy young adults. Understanding how~     participants respond to brain stimulation is critical to maximizing the effectiveness of~     stimulation and determining its potential as a performance-enhancing aid for mental tasks.~     Future developments of this study may also inform the capacity of brain stimulation to act as~     non-drug alternative to treatment for cognitive decline.~   "
81623|NCT02498561|"~     Obesity may affect periodontal health by inducing gingival oxidative damage through increased~     production in circulating reactive oxygen species (ROS). Previous studies have reported~     decreased glutathione levels in patients with periodontitis when compared to healthy subjects~     in gingival crevicular fluid (GCF), plasma and saliva. In the present study we hypothesized~     that high ROS levels in circulation may decrease glutathione levels in the GCF,plasma and~     saliva in obese patients with chronic periodontitis, whereas periodontal therapy could have~     positive effects on glutathione levels.~   "
81624|NCT02498548|"~     This project will characterize lower extremity eccentric muscle function among individuals~     who have undergone locomotor training after spinal cord injury and will evaluate the effect~     of downhill training at moderate speeds - targeted to rehabilitation eccentric function of~     the knee.~   "
81625|NCT02498535|"~     Prospective, randomized, placebo controlled, phase II clinical study of subjects crossing~     over from an approved inhaled antibiotic to inhaled nitric oxide as compared to a placebo~     control arm.~   "
81626|NCT02498522|"~     The aim of this work is to study the effect of metformin use for reducing early pregnancy~     loss in pregnant patients with Polycystic ovary syndrome (PCOS).~   "
81627|NCT02498509|"~     Clinical Trial to Evaluate the Efficacy and Safety of CKD-342~   "
81629|NCT02498483|"~     Infants do not routinely receive acetaminophen for pain control after circumcision. This~     study will determine if acetaminophen is effective at controlling infant pain after~     circumcision using nerve block and oral dextrose. Infants will undergo the routine~     circumcision procedure , and half will be randomly selected to receive half acetaminophen~     immediately at the end of the procedure. Afterwards, infant's vitals signs (heart rate,~     respiratory rate, oxygen saturation), NIPS (the neonatal infant pain scale), and salivary~     cortisol levels will be checked in regular intervals up to 4 hours. The NIPS is a validated~     pain scoring system based on the appearance of the infant. A reduction in NIPS for those~     infants who receive acetaminophen versus nothing will be our primary outcome to determine if~     our study is significant.~   "
81630|NCT02498470|"~     The registry study is to obtain the state of the percutaneous coronary intervention state~     treatment for coronary heart disease in the center of the first hospital of sun yat-sen~     unversity in a real world.~   "
81631|NCT02498457|"~     This study aim to observe the preventive effect and the long term safety of low calcium~     dialysis on coronary artery calcification in Maintenance hemodialysis (MHD) patients.~   "
81632|NCT02498444|"~     The purpose of this study is to test the efficacy of treprostinil in the perioperative~     non-fenestrated, extracardiac Fontan patients in order to reduce duration of chest tube~     drainage (in days).~      The Fontan operation is performed for patients with single ventricle physiology as the final~     palliation to create a series circulation, with passive systemic venous return to the~     pulmonary arteries and the single ventricle solely providing systemic output.~      Patients undergoing extracardiac Fontan tend to have elevation of Fontan pressures~     immediately following the operation with inflammation from surgery requiring additional fluid~     administration to maintain blood pressure. Increased Fontan pressures and fluid overload lead~     to prolonged chest tube drainage.~      The hypothesis is that treprostinil, a prostacyclin drug that dilates the pulmonary arteries,~     will improve immediate postoperative Fontan pressures. Treprostinil is not FDA approved for~     this use. Anecdotally and in a small case series, prostacyclin therapy has been shown to~     assist in transitioning patients off nitric oxide. The investigators believe that this~     improvement in hemodynamics will decrease duration of chest tube drainage resulting in a~     shorter length of hospital stay.~   "
81633|NCT02498431|"~     The investigators aim to evaluate circulating irisin levels alterations in patients with~     acute myocardial infraction and in patients with coronary artery disease subjected to~     percutaneous coronary intervention.~   "
81634|NCT02498418|"~     The primary objective is to demonstrate rifaximin 200-mg tablets (test) and Xifaxan® 200 mg~     tablets (reference ) are clinically bioequivalent with respect to the clinical cure rates~     when administered 3 times a day (TID) for 3 days in subjects with travelers' diarrhea.~   "
81635|NCT02498405|"~     The primary objective of this study is to determine if the Smartphone electrocardiogram (ECG)~     is an acceptable replacement for a standard ECG in the identification of ST Elevation~     Myocardial Infarction (STEMI).~      Toward this objective, this study involves the following:~        -  Obtain simultaneous recordings of a standard 12-lead ECG and the iPhone 12-lead~          equivalent ECG on patients presenting with chest pain in which the STEMI protocol was~          activated.~        -  Obtain simultaneous recordings of a standard 12-lead ECG and the iPhone 12-lead~          equivalent ECG on patients presenting to the Emergency Department for evaluation of~          chest pain, not necessarily presenting with STEMI.~        -  Reading of ECGs (standard 12-lead and iPhone) by three independent cardiologists, who~          are blinded to the initial clinical ECG readings, the type of ECG equipment used, and~          the patient's clinical information.~        -  Assess the operational feasibility of using the Smartphone to obtain 12-lead~          equivalent ECG recordings in patients suspected to have STEMI, and~        -  Determine the possibility of pooling the data obtained from this study with data from~          other institutions conducting identical studies, and developing a future IRB-approved~          protocol and statistical analysis plan to compare the sensitivity, specificity, positive~          predictive value and the negative predictive power of the iPhone ECG, using a paired~          standard 12-lead ECG as the gold standard.~      There will be no therapeutic interventions. A single research-related procedure will be~     required, i.e. an iPhone ECG. Effort will be made to ensure that the performance of this~     procedure will not delay any treatment and/or diagnostic procedures that are part of usual or~     specialized care that the patient requires. Effort will be made to enroll 1 STEMI patient for~     every 2 non-STEMI patients.~   "
81636|NCT02498392|"~     The purpose of this study is to evaluate the efficacy and safety and tolerability of~     JNJ-42165279 in participants with major depressive disorder (MDD) with anxiety symptoms who~     have had inadequate response to treatment with a selective serotonin reuptake inhibitor~     (SSRI) or serotonergic/noradrenergic reuptake inhibitor (SNRI).~   "
81637|NCT02498379|"~     This study is designed to assess the safety, biodistribution and dosimetry of the novel~     atherosclerotic imaging PET radiotracer, Cu[64]-25%-CANF-Comb.~   "
81638|NCT02498366|"~     In order to determine norm values for skeleton muscle disassembly due to physical exertion in~     healthy and trained population, and developing a prediction test for approval for~     rhabdomyolysis injuries to return to duty, 50 healthy subjects will undergo a series of~     different physical tests.~   "
81639|NCT02498353|"~     A randomized trial comparing weather preoperative short-course radiotherapy with local boost~     is better than conventional preoperative short-course radiotherapy for local advanced rectal~     cancer.~   "
81640|NCT02498340|"~     Glucose-6-phosphate dehydrogenase (G6PD) deficiency is prevalent and add a burden on families~     in Egypt and Middle East due to lifelong diet restriction, non-fava beans diet is main food~     for most families in the region and parents and doctors consider it as a prohibited food~     whatever the genetic or clinical phenotypes. The effective management is avoiding a spectrum~     of food and drugs causing oxidative stress. No data is available about the hazards of~     consumption of non-fava beans diet.~   "
81647|NCT02498249|"~     The aim of the present study is to assess the immediate effect of irradiation with low level~     laser therapy (LLLT) on the electromyographic activity of upper trapezius muscles and the~     amount of pain felt by patients with non-specific neck pain (NS-NP).A total of 20 patients~     with non-specific neck pain will be enrolled in a randomized, single-blind, crossover study.~     Each subject will receive two forms of treatment in random order: a single session of LLLT~     and placebo LLLT. In order to eliminate carry-over treatment effects, a one-week wash-out~     period will be respected between sessions. Surface electromyography will be used to determine~     nerve conduction velocity and activity in the upper trapezius muscles before and after~     treatment. The outcome measures will be determined by a numerical pain rating scale.~     Comparisons before and after irradiation with LLLT will determine the activity of the upper~     trapezius muscles and the level of pain. The data will be submitted to statistical tests~     considering a p-value of p < 0.05.~   "
81838|NCT02495740|"~     The effects of active commuting with an e-bike, as compared with a classic bike, on~     cardiorespiratory fitness and vascular health are largely unknown. To assess whether active~     commuting with an e-bike or a classic bike increases peak oxygen consumption (VO2peak) in~     untrained and overweight individuals.~   "
81641|NCT02498327|"~     Chronic Venous Insufficiency (CVI) is impaired venous return which results in lower limbs~     symptoms that include pain, swelling and dermatologic changes. CVI is a condition that~     affects both males and females, but is more prevalent in females due to the effect of~     progesterone on vascular tissue resulting in the dilation of veins. The predisposing factors~     for CVI include: female gender, long periods of standing, decreased physical activity,~     obesity, poor nutrition, metabolic syndrome, tight and restrictive clothing as well as~     advanced age, constipation, pregnancy and ascites. Conventional treatment may involve~     surgery, compression stockings, laser therapy, sclerotherapy and venoactive drugs, which are~     aimed at improving the appearance of varicose veins and decreasing pain and swelling.~      The combination of Red Vine, Butcher's Broom, Horse Chestnut and Vitamin B6 is an over-the~     counter herbal preparation, which is used to treat the symptoms associated with CVI. Studies~     done on each of the preparation's individual constituents demonstrate their efficacy in~     improving blood circulation, thereby alleviating symptoms associated with venous stasis. The~     individual extracts improve venous tone and blood circulation, however there are no studies~     on the combined effect of these individual ingredients and their efficacy on the quality of~     life of females affected by CVI.~      The aim of this study is to determine the efficacy of a combination of Red Vine Leaf extract,~     Butcher's Broom, Horse Chestnut and Vitamin B6 on the quality of life in female participants~     with CVI, using the Chronic Venous Insufficiency Quality of Life Questionnaire (CIVIQ-20).~   "
81642|NCT02498314|"~     In orthopaedic manual therapy translatoric grades of movement are used to determine the~     intensity of force applied during the mobilization. Different clinical effects are described~     for each translatoric grade of movement but there are not published studies evaluating these~     clinical effects.~      The objective of this trial is to determine if force magnitude during hip traction in resting~     position affects immediate and short-term outcomes (pain, physical function, hip muscle~     length and hip range of motion) in patients with hip osteoarthritis. For this purpose,~     investigators conduct a randomized clinical trial, double-blind (patient and physical~     therapist examiner). Participants entering the study were randomized into 1 of 3 treatment~     groups: grade I- grade IISZ mobilization, grade IITZ mobilization or grade III mobilization.~     Participants attend three sessions on alternate days (monday, wednesday, friday) and at the~     same hour. Measurements are taken prior to treatment, immediately after each session~     treatment.~      The participants are recruited from physiotherapy groups or referred by general practitioners~     and orthopedic surgeons.~      Participants were assigned to 1 of the 3 study groups through concealed allocation (sealed~     envelopes) and independent blocked randomization, using a random number generator.~      One physical therapist enroll patients in the study, while an independent research assistant~     performed the randomization and prepared the sealed envelopes, which are opened after~     baseline data collection by the physiotherapist performing the treatments. Participants are~     treated in a private treatment area and have no knowledge of treatments received by other~     participants.~      A second experienced orthopaedic manual therapist applies the standardized hip traction~     mobilization in resting position at either level of force, during 10 minutes. This amount of~     mobilization is consistent with clinical practice and previous studies in osteoarthritis~     patients.~      Two physiotherapists (third and fourth) with 5 years of experience, who were blinded to~     participant group, performed all measurements.The outcome measures are pain, physical~     function, hip muscle length and hip passive range of motion. Pain is registered with visual~     analogic scale (VAS), Pressure Pain Threshold ( PPT) and WOMAC pain subscale. Physical~     function is registered using Timed Up & Go test (TUG), the 20-Meter Walking Test (20MWT) and~     the physical function subscale of WOMAC index. The hip muscle length is measured using Ely´s~     test, Active Knee Extension test and modified Ober´s test. The passive hip range of motion is~     measured using inclinometer or goniometer.~   "
81643|NCT02498301|"~     The purpose of this study is to develop evidence on the relative efficacy of 2 rifaximin~     chemoprophylaxis regimens for the prevention of Travelers' Diarrhea (TD) in a deployed~     setting. An additional purpose is to explore the effect of chemoprophylaxis on microbial~     flora and antimicrobial resistance, and obtain parameter estimates to inform a~     cost-effectiveness model of chemoprophylaxis in prevention of TD. Information from this study~     will be used to develop management guidelines for the prevention of TD among deployed (United~     States (US) and United Kingdom (UK) military personnel.~      The study will be a multi-site, randomized, placebo-controlled, double-blind, clinical trial~     among deployed military personnel. The study will test 2 TD chemoprophylaxis regimens (once~     daily versus twice daily) of the same antibiotic, rifaximin, compared to a placebo.~      For the proposed chemoprophylaxis study described herein, cohorts of military personnel (US~     and UK) deploying/traveling overseas will be recruited prior to travel to participate and~     will undergo enrollment procedures as outlined in study appendices. Subjects who are eligible~     and agree to participate will be randomized to receive one of 3 regimens: (1) rifaximin 550~     mg daily; (2) rifaximin 550 mg twice a day; or (3) placebo, to be taken while deployed.~     Chemoprophylaxis will be maintained for duration of travel or a predetermined period of up to~     6 weeks and at least 2 weeks, which may include a period of up to 5 days of use after return~     to COO for deployments less than 6 weeks in duration. Clinical and laboratory data will be~     obtained before, during if available and after deployment/chemoprophylaxis.~   "
81644|NCT02498288|"~     This is an open-label, crossover, randomized, single dose, three treatments, three periods~     and six sequences, single dosage, balanced study to determine Bioequivalence of Isotretinoin.~     Bioequivalence will be compared between the reference medication one (T1) vs the test~     medication (T3): (T1 vs T3); and the reference medication two (T2), vs test medication (T3):~     (T2 vs T3). Finally, treatments T1 vs T2 will be compared statistically to determine if they~     are bioequivalent.~   "
81645|NCT02498275|"~     This is an exploratory study to characterize the ex vivo immune response to RO6871765 or~     RO7011785 stimulation of peripheral blood mononuclear cells (PBMCs) extracted from healthy~     volunteers and chronic hepatitis B (CHB) patients.~   "
81646|NCT02498262|"~     Using Virtual Reality and Robotics Technologies for Vocational Evaluation, Training and~     Placement (VR4VR) is a project that incorporates Virtual Reality into job training to~     increase job opportunities for people who have physical or mental disabilities. The~     investigators are using Virtual Reality and robotics for job evaluation, training and~     placement of people with disabilities. The investigators' goal is to assess and train people~     in a safe, adaptable, and fun virtual environment similar to a video game.~      This is an interventional study with three target populations: autism spectrum disorder,~     traumatic brain injury, and severe mobility and manipulation impairments. The prototype~     system allows for a wide range of environments with the vocational evaluator easily~     controlling the virtual experience, while the job seekers interact realistically.~   "
81648|NCT02498236|"~     This study will evaluate the effect of 8 doses of intranasal oxytocin or placebo on two~     proposed measures of target engagement in brain. The targets are (1) the suppression of a~     particular wave form (mu) on the electroencephalogram (EEG) while subjects observe a socially~     relevant form of motion and (2) pupil dilation will subjects identify faces showing different~     emotions.~   "
81663|NCT02498041|"~     This study evaluates the diagnostic accuracy, safety and acceptability of transnasal~     endoscopy (TNE) for a diagnosis of Barrett's esophagus (BE). This is a cross-over randomised~     trial, whereby patients receive two endoscopic procedures 2-4 weeks apart and will be~     randomised to receive either TNE or standard endoscopy followed by the other procedure.~   "
81650|NCT02498210|"~     Poor ovarian response (POR) is one of the major therapeutic challenges in in vitro~     fertilization. Several therapeutic approaches for POR have been explored; yet, a single~     effective strategy has not yet been established. Recently, a live birth was reported after~     ovarian cortex fragmentation and in vitro disruption of the Hippo signaling pathway and~     activation of Akt signaling. During IVM procedure increased mechanical stimulation of the~     ovarian cortex takes place. , with the consequent disruption of the Hippo signaling pathway.~     Our aim is to investigate whether the mechanical manipulation and triggering of ovarian~     cortex caused by IVM can cause ovarian follicular activation and recruitment by the~     mechanisms mentioned above. Thus stimulation in the following regular IVF cycle will result~     in improved ovarian response and increased oocytes yield~   "
81651|NCT02498197|"~     There is high prevalence of back pain and neck-shoulder pain among blue collar workers.~     Physical excessive exposures such as heavy lifting or working with a bended or twisted back~     are independent risk factors for back pain among workers in the construction industry.~     Participatory ergonomic initiatives increase the success of interventions aimed at reducing~     physical excessive exposures.~      The objectives are in two phases to; 1) determine which work-tasks in selected job-groups~     involve the highest load of the back and shoulders during a normal working day (using EMG,~     Actigraphs, Video). 2) investigate whether a participatory intervention can reduce physical~     workloads, drawing on information from objective measurements from phase 1.~   "
81652|NCT02498184|"~     This is a double-blinded, randomized, controlled study on the effect of perioperative~     acupuncture on pain after third molar extraction.~   "
81653|NCT02498171|"~     This study is aimed at evaluating single short spinal technique as a form of labour analgesia~     in a setting where more expensive and labor intensive techniques are not feasible.The study~     will examine the safety and efficacy of two drug combinations (intrathecal morphine+fentanyl~     vs intrathecal morphine+bupivacaine) through a randomized control trial.~      The investigators hypothesize that a single shot of either intrathecal morphine plus fentanyl~     or intrathecal morphine plus bupivacaine achieve analgesia and are safe in parturients~     experiencing normal labour.~   "
81654|NCT02498158|"~     Functional neural connectivity at rest of 3 groups (heat tolerant, heat intolerant and~     healthy subjects) will be assessed using the anatomical and functional MRI scans and~     compared.~   "
81655|NCT02498145|"~     This is a pilot human experimental study to evaluate whether the use of an e-cigarette~     affects lung function, exhaled CO levels, and quantitative tobacco cigarette consumption in~     active tobacco smokers. Subjects recruited from the Winchester Chest Clinic (WCC), Adult~     Primary Care Clinic (PCC) and the Smilow Cancer Hospital Smoking Cessation Service will be~     randomized to 1 of 2 groups: (1) nicotine patch and intensive counseling (standard care) plus~     nicotine e-cigarette; (2) nicotine patch and intensive counseling plus non-nicotine~     e-cigarette.~   "
81656|NCT02498132|"~     Elevated depressive symptomatology is a widespread public health concern and individuals with~     elevated depressive symptoms most frequently report such symptoms to primary care physicians~     (PCPs). PCPs have few evidence-based resources beyond antidepressant medication for treating~     elevated depressive symptoms, which results in negative outcomes for their depressed~     patients. Mobile technologies offer an ideal strategy to meet widespread treatment needs. The~     purpose of the proposed project is to\ customize Behavioral Activation (BA), a~     straightforward, empirically supported treatment for elevated depressive symptoms, for a~     mobile format (Moodivate) in order to address the currently unmet needs of PCPs and their~     patients with elevated depressive symptoms.~   "
81657|NCT02498119|"~     The purpose of this study is to determine whether an increase in lipid bodies in leukocytes~     will lead to an increase in eicosanoid production. The 2nd purpose is to determine if there~     is a significant correlation between lipid body formation and enhanced generation of both~     Lipoxygenase (LO) and COX derived eicosanoids. The 3rd purpose is, if lipid bodies are~     involved in arachidonic acid (AA) metabolism, then AA present in these lipid rich structure~     must be released by phospholipases and the free Arachidonic Acid (AA) must have access to the~     eicosanoid forming enzyme. The fourth objective is to determine the compartmentalisation of~     cPLA2 and MAP kinases including ERK1, ERK2, p85 and p38 are involved in AA liberation within~     lipid bodies.~   "
81658|NCT02498106|"~     The overall goal of this study is to investigate whether the daily administration of~     multivitamins, minerals and n-3 fatty acids will reduce aggression in long-term psychiatric~     inpatients and will thereby reduce costs of care.~   "
81659|NCT02498093|"~     Conventional rehabilitation after total hip arthroplasty (THA) does not seem to restore~     muscular strength or walking speed. Three-5 years after surgery patients are still not fully~     rehabilitated. This study evaluates the effects of maximal strength training on the muscular~     strength in leg press and abduction in patients undergoing THA. Aim of the study is to~     increase the patients physical function through evidence-based rehabilitation in clinical~     practice, with gradually less supervision.~   "
81660|NCT02498080|"~     Percutaneous transluminal angioplasty (PTA) of infra-popliteal arteries in patients suffering~     peripheral arterial occlusive disease (PAOD) provides good results in terms of limb salvage.~     During the last decade, drug eluting balloons (DEB) were found to be an effective tool for~     the treatment of atherosclerotic disease in several arterial districts. Aim of this study is~     to compare results of DEB PTA versus standard PTA of infra-popliteal district in patients~     with CLI, from a single-centre prospective randomized trial.~   "
81661|NCT02498067|"~     The investigators will develop a digital application (app)—rPlan dual protection (rPlan)—to~     be used in the clinic waiting room prior to a gynecological and/or contraceptive visit. The~     goal of this research is to develop the app and conduct a feasibility, acceptability and~     effectiveness assessment of rPlan to examine improvement in dual method use, enhancement of~     contraceptive adherence and continuation, increase of condom use and decrease of sexually~     transmitted infection (STI) and human immunodeficiency virus(HIV) infection. The research~     will consist of baseline activities as well as 6 week phone call and 12 week in-clinic survey~     and STI test, as well as a retrospective chart review.~   "
81662|NCT02498054|"~     A single visit & single arm study in 80 subjects with diabetes to determine if a short~     educational experience with a new blood glucose meter feature improves the ability of each~     subject to better classify glucose results into acceptable glucose ranges.~   "
81665|NCT02498015|"~     A total of 100 people with chronic HCV and recent injection drug use or recipients of opioid~     substitution therapy will be enrolled in 5 countries and 21 study sites. Participants with~     genotype 1a infection or cirrhosis will receive 12 weeks of open-label~     paritaprevir/ritonavir/ombitasvir and dasabuvir (3D), and twice-daily ribavirin.~     Participants with genotype 1b infection without cirrhosis will receive 12 weeks of open-label~     3D. The study consists of a screening phase (6 weeks), treatment phase (12 weeks) and~     follow-up phase (96 weeks) to evaluate treatment response and reinfection.~   "
81666|NCT02498002|"~     Obesity is a global concern with links to conditions such as diabetes. Historically, these~     conditions have been managed by reducing energy intake on a daily basis, which is often~     hampered by low adherence rates and compensatory reductions in physical activity.~     Intermittent fasting (IMF) has become popular as an alternative method of weight loss, where~     periods of normal eating are punctuated by days of fasting. However, despite its popularity,~     IMF is scarcely examined within the literature.~      This study will examine the impact of IMF on energy balance and the associated health~     outcomes relating to conditions such as diabetes. To achieve this, 36 lean adults and 36~     overweight/obese adults will be recruited, excluding those with conditions which may be~     adversely affected by fasting. Once enrolled, participants will complete a one month control~     phase, incorporating 12 days of diet and activity monitoring, to ensure their weight is~     stable before moving in to the intervention phase.~      The intervention phase will begin with a lab protocol designed to examine body composition,~     resting metabolic rate and metabolic responses to two successive meals. Once completed,~     participants will be randomised to one of three diets which are listed below. Comparing the~     changes seen with diets 1 and 2 will provide the first direct comparison of IMF against more~     conventional strategies, while diet 3 will allow us to ascertain the role of weight loss in~     mediating any effects of IMF.~        1. Daily calorie restriction - Reduce energy intake by 25% on a daily basis~        2. IMF with weight loss - Alternate between 24 hour cycles of fasting and feeding with 150%~          of normal intake when feeding~        3. IMF without weight loss - Alternate between 24 hour cycles of fasting and feeding with~          200% of normal intake when feeding~      All three diets will last for 20 consecutive days, with transitions between each 24 hour diet~     cycle occurring at 15:00 each day to allow at least one main meal per day. When fasting,~     participants will only be permitted water and black tea/coffee to eliminate energy intake.~     Once again physical activity and diet will be monitored for 12 days during the intervention~     to examine changes in energy expenditure and ensure compliance.~      Having completed all 20 diet cycles participants will return to the laboratory to repeat the~     protocol described earlier. Comparing these results against the values seen before the~     intervention will then allow the effects of IMF to be identified and compared.~   "
81667|NCT02497989|"~     The purpose of this study is to evaluate the impact of two interventions - Inter-Personal~     Communication [IPC] and Dedicated Service Outlets [DSOs] - in recruiting men aged 25-39 years~     for Voluntary Medical Male Circumcision (VMMC) services.~   "
81668|NCT02497976|"~     A Randomized, Double-blind, Placebo Controlled Trial of Certolizumab Pegol in Women with~     Refractory Interstitial Cystitis/Bladder Pain Syndrome~   "
81669|NCT02497963|"~     The purpose of this study is to determine the efficacy and safety of tubularized incised~     plate urethroplasty versus foreskin graft tubularized incised plate urethroplasty in primary~     hypospadias. This study only included patients with width of urethral plate ≤ 7 mm, width of~     glans ≤ 14 mm, and urethral plate depth shallow o moderate.~   "
81670|NCT02497950|"~     Evaluate real-world experience of HeartMate 3 (HM3) in post-approval setting.~   "
81671|NCT02497937|"~     This study is a single centre, randomised, double-blind, sponsor-unblinded,~     placebo-controlled, 2 by 2 crossover study in adults with heart failure. In blocking the~     TRPV4 ion channel and reducing pulmonary interstitial fluid, GSK2798745 may improve pulmonary~     function, respiration, and gas exchange as well as sleep-disordered breathing in patients~     with heart failure. Therefore, the current study is designed to investigate the effect of~     repeat administration of GSK2798745 on pulmonary gas exchange and pulmonary function.~      A sufficient number of subjects with heart failure will be enrolled so that 12 subjects~     complete the two study periods and critical assessments. Subjects will be randomised to~     receive either GSK2798745 or placebo once daily for a period of 7 days in one treatment~     period and alternate study medication in the second treatment period. Both the treatment~     periods will be separated by a washout period of at least 14-days.~      This study will consist of a Screening visit within 14 days of the start of Period I and two~     treatment periods wherein eligible subjects will be randomised to one of the two treatment~     sequences, a follow-up visit approximately 2 weeks after the completion of second study~     period. The total duration of the study is approximately 8 weeks from screening to follow-up~     visit.~   "
81672|NCT02497924|"~     This study will provide information regarding the metabolic pathway of GBT440, the need for~     evaluation of potential drug-drug interactions, and the need for studies in special~     populations. The administration of radiolabeled drug is necessary to fully characterize the~     rates and routes of elimination of GBT440, providing further quantitative information on the~     disposition of GBT440. The results from this study will permit a comprehensive comparison~     between animal and human routes of elimination and metabolic profiles of GBT440.~   "
81673|NCT02497911|"~     The study is a prospective randomized controlled trial comparing intraarticular catheters and~     adductor canal catheters for postoperative analgesia following a primary Total Knee~     Arthroplasty (TKA).~   "
81674|NCT02497898|"~     The purpose of this study is to study the safety and efficacy of chemotherapy usage followed~     by CIK transfusion in refractory and/or chemoresistant lymphomas.~   "
81675|NCT02497885|"~     The investigators aim to do serosurvey of healthcare-personnel who had participated in~     treatment of confirmed patients of Middle-East respiratory syndrome. The investigators~     collected the base-line (pre-exposure) serum of healthcare-personnel in a few centers, and~     will collect the post-exposure serum from about 25-30 centers in which confirmed MERS~     patients had been treated.~      The investigators will deduct the seroprevalence of MERS-CoV IgG among the healthy~     healthcare-personnel, and calculate the sero-conversion rate if possible. The investigators~     will subdivided the seroprevalence according to the degree of exposure and preparedness of~     personal protective equipment.~   "
81712|NCT02497391|"~     The purpose of this study is to determine if there is any difference in the way the body~     handles 3 types of evacetrapib tablets with different particle sizes. Information about any~     side effects will also be collected. This study will consist of 3 study periods. Participants~     will be dosed 3 times during the entire study. Each study period will consist of an inpatient~     stay for 3 days - the day before dosing (Day -1), dosing day (Day 1) and the day after dosing~     (Day 2). Then participants will be asked to return to the clinical research unit (CRU) daily~     for outpatient appointments up to Day 8. The overall length of this study is about 7 weeks~     from first dose to end of study. Screening will take place within 28 days prior to the first~     dose of evacetrapib and follow-up will take place 21 days after the last dose of evacetrapib.~   "
81713|NCT02497378|"~     The purpose of this study is to evaluate the tolerability and safety of JNJ-54767414~     (daratumumab) in Combination With Bortezomib and Dexamethasone (D-Vd) in Japanese~     participants with relapsed (the return of a medical problem) or refractory (not responding to~     treatment) multiple myeloma.~   "
81676|NCT02497872|"~     BACKGROUND: The most common complication of endoscopic retrograde cholangiopancreatography~     (ERCP) is pancreatitis. Precut sphincterotomy has been regarded as a risk factor. However,~     early precut may actually reduce post-ERCP pancreatitis risk. However, early precut as a~     preventive measure has not been compared to other preventive measures, such as pancreatic~     duct stent placement.~      AIM: To compare the efficacy of early precut sphincterotomy versus pancreatic duct stent~     placement in high-risk subjects undergoing ERCP.~      MATERIALS AND METHODS: This is a single-blinded, randomized trial that took place in two~     tertiary referral centers in Buenos Aires. ERCP subjects shall present at least one of the~     following risk factors: female sex, age less than 40 years, clinical suspicion of Sphincter~     of Oddi dysfunction, previous pancreatitis, common bile duct diameter of less than 8 mm. Only~     those who present a difficult biliary cannulation shall be randomized into two groups: those~     who receive early precut sphincterotomy or those in whom persistency of biliary cannulation~     is intended with subsequent pancreatic duct stent placement after cholangiography is~     achieved. The incidence of post-ERCP pancreatitis as well as other complications shall be~     compared.~   "
81677|NCT02497859|"~     The experiments in this study will assess if while following a reduced energy diet, eating a~     breakfast with higher protein quality will enhance weight loss compared to another breakfast~     with lower protein quality, but matched for energy density and macronutrient composition.~   "
81678|NCT02497846|"~     The purpose of this study is to evaluate the feasibility and acceptability of a TEOSYAL®~     PureSense Redensity [I] injection using MicronJet® needle in the treatment of crow's feet~     wrinkles.~      It is a monocentric, open-blind, prospective, pilot study. 3 injections sessions spaced with~     an interval of 3 weeks. The last visit will be performed 3 weeks after the last injection.~      Only, one group of 15 healthy volunteers will be included.~   "
81679|NCT02497833|"~     The aim of the study is to investigate the effects of retinoic acid on the HDL-PON1 activity~     and cholesterol efflux capacity in hypercholesterolemic subjects.~   "
81680|NCT02497820|"~     A randomised double blind dose non-inferiority trial of a daily dose of 600mg versus 300mg~     versus 100mg of enteric coated aspirin as a cancer preventive in carriers of a germline~     pathological mismatch repair gene defect, Lynch Syndrome. Project 3 in the Cancer Prevention~     Programme (CaPP3).~   "
81681|NCT02497807|"~     The purpose of this study is to characterize the functional and anatomical connectivity~     changes in Tourette syndrome and its relation with iron deficiency.~   "
81682|NCT02497794|"~     This study is a randomised controlled trial that included 150 pregnant women undergoing~     cesarean in Sisli Ethal Training and Research Hospital, Department of Obstetrics and~     Gynecology, Istanbul, Turkey. It was carried out in the period from October 1, 2015 to~     December 31, 2015. After operation, the participants are going to randomly assigned into two~     groups by using cards. The patients are going to randomized into two groups by using a sealed~     enveloped system.The patients in the study group, will chew one sugar less gum for 30 minutes~     in postoperative 3., 5. and 7. hours. The control group will be followed without chew gum.~     All patients will note the time of first rumbling of the stomach, first feeling of hunger and~     the first gas outlet.~   "
81683|NCT02497781|"~     This study will assess the safety, tolerability and efficacy of ceftazidime and avibactam~     (CAZ-AVI )versus cefepime in children from 3 months to less than 18 years old with~     complicated urinary tract infections.~   "
81684|NCT02497768|"~     The investigators want to understand how oral processing (chewing) of nuts affects particle~     size and the presence of lipid (fat) on the cut surfaces.~      The main objective of the study is to:~      Measure the size of nut particles that have been chewed sufficiently to be swallowed.~      The secondary objective of this study is to:~      Measure any changes in lipid content due to chewing and compare it to a prediction from a~     theoretical model.~      The investigators have developed a theoretical model for determining the release of nutrients~     from plant foods, specifically lipid (fat) from almonds. The model has been used to calculate~     the amount of lipid released from chewed almonds. The model shows that only about 10% of the~     lipid is immediately released. The investigators require information on the particle size~     distribution (number of particles of each size) for other chewed nuts to calculate the amount~     of lipid released for other nuts. This will allow us to check the validity of our model for~     other foods.~   "
81685|NCT02497755|"~     This is a pilot feasibility study of a mobile health tool (smartphone app) for primary care~     patients receiving treatment for depression or anxiety delivered in an integrated primary~     care-based behavioral health program.~   "
81686|NCT02497742|"~     Twice daily basic metabolic panel's or labs are common practice at Vanderbilt University~     Medical Center. However, it is unclear how often the second BMP each day is acted on. the~     investigators project aims to answer a few fundamental questions about the need for twice~     daily labs in patients hospitalized with acute/subacute-decompensated congestive heart~     failure who are being actively diuresed.~   "
81687|NCT02497729|"~     The use of a written, pre-procedure checklist and positioning the patient with the head of~     the bed elevated have been proposed as interventions capable of preventing complications~     during non-elective intubation and are used intermittently in routine care -- however neither~     have been examined in a prospective trial.~   "
81688|NCT02497716|"~     To characterize the pharmacokinetic profile of rivaroxaban administered as granules for~     suspension formulation and to document safety and tolerability~   "
81689|NCT02497703|"~     An exoskeleton robotic knee system for stroke rehabilitation is proposed in this study. This~     robotic system has been developed to facilitate functional motor recovery by practices~     walking with a one joint motor powered exoskeleton to reduce the muscle weakness in the shank~     and reduce the hyperextension in the knee joint. The robotic knee system is able to sense the~     gait pattern from the stroke patients and assist the walking and control the knee angle. The~     clinical trial will use repeated measurements to evaluate the effectiveness of the robotic~     knee system in gait rehabilitation post stroke.~   "
81690|NCT02497690|"~     This study will assess the effectiveness of post-cochlear implant or hearing aid fitting~     Aural Rehabilitative Therapy (ART) delivered by means of telemedicine technology.~   "
81714|NCT02497365|"~     This is a study comparing a new treatment for bacterial keratitis (also known as corneal~     ulcers) with the current standard of care. It is a randomized trial, and the investigators~     plan to test whether besifloxacin (a new antibiotic) in comparison to the current standard of~     treatment, fortified antibiotic drops (cefazolin and tobramycin).~   "
81691|NCT02497677|"~     Infant mental health is a significant public health issue as early adversity and expose to~     childhood stress has life-long consequences for the affected children. Helping families at~     risk correct their adverse effects on the infant has the potential to halt a negative spiral~     effect where vulnerable parents fail to cope with an at-risk child - which in turn, adds to~     the child's vulnerability, negatively affects the parents, and so forth. Over a four year~     period, an estimated 17.600 dyads will be screened in the City of Copenhagen using~     standardized screening instruments in detecting infant social withdrawal (ADBB) and maternal~     postnatal depression (EPDS). A sample of 314 eligible parent(s) will enter into a clinical,~     randomized control trial to test the efficacy of an 8 week group counseling program, Circle~     of Security Parenting (COS-P) compared to Care as Usual(CAU) in enhancing maternal~     sensitivity, child attachment and cognitive development. CIMHP is the first large-scale~     randomized controlled study to test the efficacy of COS-P in promoting parental sensitivity,~     child attachment and cognitive development in Denmark. Results will provide evidence~     regarding the efficacy of an American short term indicated parenting group program when~     implemented in a Scandinavian country.~   "
81692|NCT02497664|"~     Neo-adjuvant chemoradiotherapy (neo-CRT) is increasingly applied in the curative treatment of~     esophageal cancer, with the aim to downstage the tumor, to increase the rate of radical~     resections, and consequently to improve the survival rates. Due to improved survival, it will~     become increasingly important to minimize the radiation-induced toxicity among long-term~     survivors.~      In the management of locally advanced non small cell lung cancer (NSCLC), radiotherapy is the~     standard treatment modality. However, the dose that can be safely applied to the tumour is~     limited by the risk of cardiac and pulmonary complications, which even led to decreased~     survival in a randomised study, when a higher tumor dose was administered [1].~      Radiation induced pulmonary and cardiac toxicity are the most important late side effects~     after thoracic radiotherapy [2-4].~      The aim of this study is to reduce the radiation dose of heart (and lungs) in order to reduce~     the toxicity risk.~      In recent years, the active breathing control (ABC) technique has been introduced in the~     radiotherapy for left sided breast cancer patients, to minimize the radiation dose to the~     heart. These patients are irradiated in the inspiration phase, in which the distance between~     the heart and the breast is largest, while the lungs extend.~      Breath hold might also be beneficial for radiotherapy of esophageal and lung tumors. For~     these patients the expiratory phase might theoretically be more beneficial to reduce the~     heart dose. However, the inspiration phase might be better for the dose to the lungs, which~     consequently allows cardiac dose reduction.~   "
81693|NCT02497651|"~     The study aims to evaluate the effect of smoking on postprandial responses such as plasma~     glucose, secretion of gut - and pancreatic hormones and gastric emptying in healthy, heavy~     smoking men.~   "
81694|NCT02497638|"~     This study is a randomized trial examining the administration of a combination of biguanide~     metformin and atorvastatin (Lipitor) to men who are experiencing rising prostate-specific~     antigen (PSA) levels, despite having undergone radical therapy (surgery and/or radiation).~   "
81695|NCT02497625|"~     This study aims to evaluate the effectiveness of minimal intervention and therapeutic~     alliance in pain, specific and general disability, global perceived effect, empathy,~     credibility and expectation of improvement in patients with chronic non-specific low back~     pain~   "
81696|NCT02497612|"~     Primary Objective:~      To determine whether a single dose combination of OZ439 (Artefenomel)/FQ (Ferroquine) is an~     efficacious treatment for uncomplicated Plasmodium falciparum malaria in adults and children.~      Secondary Objectives:~      - To evaluate the efficacy of OZ439 (Artefenomel)/FQ (Ferroquine): .To determine the~     incidence of recrudescence and re-infection. .To determine the time to relief of fever and~     parasite clearance.~        -  To evaluate the safety and tolerability of OZ439 (Artefenomel)/FQ (Ferroquine).~        -  To evaluate the pharmacokinetics of OZ439 (Artefenomel)/FQ (Ferroquine).~        -  To explore in vitro drug resistance of P. falciparum infecting patients >14 years old in~          Vietnamese sites.~   "
81697|NCT02497599|"~     Intraoperative tumor localization and resection can be enhanced using intraoperative~     fluorescence imaging and radiodetection. Girentuximab specifically recognizes carbonic~     anhydrase IX expressed on > 95% of renal cell carcinoma (RCC). Therefore~     Indium-111-DOTA-girentuximab-IRDye800CW is a perfect dual-labeled antibody for dual-modality~     image-guided surgery in RCC.~      The aim of this study is to assess the feasibility and safety of intraoperative dual-modality~     imaging with Indium-111-DOTA-girentuximab-IRDye800CW in renal cell carcinoma patients.~   "
81698|NCT02497586|"~     Lung cancer is commonly characterised either with a surgical procedure or by taking a tissue~     sample with a needle. Unfortunately, these invasive approaches may be unsafe in many patients~     with lung cancer, who often have co-existing illnesses such as emphysema.~      Magnetic resonance spectroscopy (MRS) is a type of scan which offers the possibility of~     assessing tumour function by measuring concentrations of chemicals (metabolites) within the~     abnormal tissue. It is a well-established technique in imaging brain cancers. It has also~     been more recently studied in assessing prostate, liver and heart. There has been very little~     exploration of the potential role of MRS in lung cancer.~      The proposed feasibility study will recruit 15 patients with proven lung cancer to undergo an~     MRS scan. The reliability of the technique for metabolite measurement will be determined by~     comparing repeated scans from the same region in the same tumour. Further scans from~     different regions in the same tumour, normal lung around the tumour and tumour regions in~     different patients will be used to look for any patterns in the cancer metabolites which may~     indicate avenues for potential future research.~   "
81699|NCT02497573|"~     Around 50% of patients with locally advanced H&N cancer fail to achieve loco-regional~     control. Currently it cannot be predicted, during treatment, who will fall into this group of~     non-responders.~      This study is designed to assess the value of DW MRI as a predictive biomarker of response to~     radiotherapy in intermediate and high risk OPSCC.~   "
81700|NCT02497560|"~     This is a randomized, masked, placebo controlled study to assess the effect on a nutritional~     dietary supplement on menopausal signs and symptoms in perimenopausal women.~   "
81725|NCT02497222|"~     This study evaluates the use of RNS60 in the treatment of asthma examining regional~     improvements in inflammation using PET imaging. All subjects will be treated with both RNS60~     and placebo in a crossover design.~   "
81701|NCT02497547|"~     Up to 50% of postmenopausal women frequently suffer from atrophic vaginitis or vaginal~     atrophy with symptoms including vaginal dryness, irritation, burning, itching or discomfort.~     Vaginal atrophy is a consequence of the lining tissue of the vagina becoming thinner, drier,~     and less elastic due to lack of estrogen. In addition, vaginal atrophy is associated with an~     increased pH, which creates an environment more susceptible to infections.~      Menopausal hormone therapy is a common treatment for vaginal atrophy. However, menopausal~     hormone therapy has been shown to coincide with an increased incidence of breast cancer,~     heart attack and stroke. Some women experience adverse reactions such as uterine bleeding,~     perineal pain, and breast pain with menopausal hormone therapy. Many women are also reluctant~     to initiate estrogen treatment, due to a general negative view of menopausal hormone therapy~     in the society. There are also many contraindicated conditions like undiagnosed vaginal~     bleeding, thromboembolic disease, breast cancer, other estrogen-sensitive cancers, or liver~     disease. Women suffering from vaginal atrophy and presenting with these conditions have~     extremely limited options for effective therapy.~      Oxytocin is a peptide hormone, normally released into the circulation via the pituitary.~     Oxytocin has been shown in vitro to exert positive effects on the proliferation of human~     vaginal mucosal cells from postmenopausal women. Local application of oxytocin, in the form~     of a vaginal gel, Vagitocin, has been investigated in previous studies on postmenopausal~     women, as a new effective and safe option for the treatment of vaginal atrophy. Vagitocin~     appeared to reverse the manifestation of vaginal atrophy by stimulating vaginal mucosal~     growth, reducing symptoms of vaginal atrophy and increasing the patients' wellbeing and~     quality of life. Overall, treatment with Vagitocin was safe and well tolerated by the~     subjects in the studies.~      In this study, the clinical efficacy of Vagitocin as a potential treatment for postmenopausal~     women suffering from moderate to severe symptoms of vaginal atrophy, vaginal~     irritation/itching and vaginal discomfort and/or pain associated with sexual activity will be~     explored. In addition, the dose relationship and lowest effective dose of Vagitocin will be~     investigated.~   "
81702|NCT02497534|"~     The purpose of this project is to characterize measures of cardiac performance and~     neuromuscular physiology in FA patients using novel techniques, including echocardiography~     and magnetic resonance imaging (MRI), metabolic exercise testing, and neurophysiological~     outcomes.~   "
81703|NCT02497521|"~     The German ADPKD Tolvaptan Treatment Registry is a prospective, observational, multicentric~     study of patients suffering from ADPKD that are considered for tolvaptan treatment. All ADPKD~     patients that are evaluated for treatment indication, or that are planned to be treated with~     tolvaptan, or that are already treated with tolvaptan are eligible. This registry is designed~     to provide real-world data on treatment management of patients with ADPKD.~   "
81704|NCT02497508|"~     This is a prospective, single arm, phase II trial in previously treated patients with MPM who~     are considered candidates for immunotherapy and repeat thoracoscopies/transthoracic biopsies.~     Nivolumab will be administered 3 mg/kg q2 weeks by intravenous injection.~      The administration of nivolumab as monotherapy will improve DCR form 20% to 40% at 12 weeks~     when compared to DCR of patients treated with best supportive care based on historical~     controls.~   "
81705|NCT02497495|"~     Introduction: immersion cold water is a recuperative strategy commonly used, however, are not~     yet fully understood the real effects of this technique on specific conditions. Objective: To~     analyze and to compare the effects of the immersion cold water during the intense~     post-exercise recovery, using different times and temperatures on biological, clinical and~     metabolic variables. Method: 105 male subjects were divided into five groups: one control~     group (CG) and four recoveries (G1: 5' at 9±1 degrees Celsius; G2: 5' at 14±1 degrees~     Celsius; G3: 15' at 9±1 degrees Celsius; G4: 15' at 14±1 degrees Celsius). The volunteers~     were submitted an exhaustion protocol that consisted of a program of jumps and the Wingate~     test. Immediately after the exhaustion protocol, volunteers were directed to a tank with~     water and ice, which were immersed up to the height of the anterior superior iliac spine to~     the recovery procedure, during which blood samples were collected for later analysis lactate~     and creatine kinase (CK). Variables were collected prior to the exercise, 24, 48, 72 and 96~     hours after the end of it. Furthermore, the perception of pain and recovery of the lower~     limbs were also collected at specific moments by means respectively of the Likert scale of~     perceived effort and visual analogue scale pain. Appropriate statistical analysis was used to~     compare the groups and the moments, considering the 5% level of significance.~   "
81706|NCT02497469|"~     The purpose of this study is to evaluate the efficacy and safety of vedolizumab intravenous~     (IV) treatment compared to adalimumab subcutaneous (SC) treatment over a 52-week treatment~     period.~   "
81707|NCT02497456|"~     The purpose of this study is to evaluate the impact of follow-up counselling after HIV~     diagnosis through home-based HIV counselling and testing (HBHCT), on linkage to~     pre-antiretroviral therapy (pre-ART) care in Uganda.~   "
81708|NCT02497443|"~     • The goal of this study was to evaluate the safety and efficacy of autologous MSC~     application for the therapy of drug-resistant symptomatic epilepsy. Adult (18-60 years old)~     patients (pts) of both sexes suffering from refractory epilepsy with frequent (>5 events per~     month) seizures were included in this study. The pts were randomized to the standard~     treatment with anti-epileptic drugs (control group, 30 pts) or anti-epileptic drugs plus~     autologous mesenchymal stem cells (MSCs) (study group, 30 pts). The pts in the study group~     received one intravenous injection of ex vivo expanded MSCs (40-101 x 106 cells) and one~     subsequent endolumbal injection of neuroinduced MSCs (2.7 - 8.0 x 106 cells). Both the~     unfavorable reactions to MSC infusions and the clinical effects, including complications,~     were examined. The unfavorable reactions to the MSC injections included local pain or~     hemorrhage at the site of injection and systemic reactions of the central nervous system~     (CNS; i.e., hyperthermia, fatigue, and myalgia).The possible beneficial effects of therapy in~     the two groups of pts were examined based on clinical observations and electroencephalography~     measurements (prior and 12 months after the application of the MSC-based therapy). To~     determine potential changes in disease progression, the signs of cognitive impairment,~     behavioral disorders, and particularly, changes in seizure character and frequency were~     evaluated using the National Hospital Scale of Seizure Severity. The main points of disease~     monitoring were yes or no responses (to therapy), seizure frequency (per month), and~     remission of disease. Electroencephalography (EEG) recordings were performed to evaluate~     electrical alpha, beta, theta and delta waves based on standard and additional criteria. The~     paroxismality index, the peak frequency of EEG activity, the index of slow activity, and the~     summarized points of EEG pathology signs were calculated for each patient. All assessments~     were performed for the pts in the control and study groups, and the obtained data were~     compared to identify the potential differences between the two pts groups. Therapy was~     terminated when immediate unfavorable reactions to the MSC injections were observed. The~     final observation of each patient included clinical and EEG assessments at the time point of~     12 months (or more) after the application of the MSC-based therapy.~   "
81709|NCT02497430|"~     The ARIES GBS Assay is a real-time PCR based qualitative test designed to detect Group B~     Streptococcus (GBS) nucleic acid from Lim Broth enriched vaginal-rectal specimen swabs~     obtained from pregnant women between 35 - 37 weeks gestation.~   "
81710|NCT02497417|"~     The ARIES C. difficile Assay is a real-time PCR based qualitative in vitro diagnostic test~     for the direct detection of C. difficile nucleic acid in stool specimens.~   "
81711|NCT02497404|"~     The purpose of this study is to determine whether 5-Azacytidine priming before the~     conditioning regimen for subjects receiving a hematopoietic stem cell transplant is an~     effective treatment for high risk myeloid malignancies in complete remission (CR).~   "
81773|NCT02496598|"~     The purpose of this study is to evaluate the effectiveness of an experimental treatment,~     known as in vitro activation (IVA) of dormant ovarian follicles, for infertility in women~     diagnosed with primary ovarian insufficiency (POI).~   "
81715|NCT02497352|"~     To evaluate the effects of flaxseed supplementation on fasting blood sugar, lipid profile and~     anthropocentric measurements in subjects with metabolic syndrome, in a randomized,~     open-labeled, controlled pilot study, 44 subjects with metabolic syndrome will be received~     30g/d flaxseed with lifestyle modification or lifestyle modification alone for 12 weeks. Both~     groups will be advised to follow an energy balanced diet and physical activity~     recommendations. Parameters related to metabolic syndrome will be measured at the baseline~     and at the end of the study.~   "
81716|NCT02497339|"~     This study has the following objectives:~        1. To raise the awareness of female smokers about the harmfulness of tobacco towards their~          life issues~        2. To encourage female smokers to stop using tobacco~        3. To assess the effectiveness of mindfulness approach for smoking cessation in women~      We will use cluster randomisation. About 40 companies (5 smokers / company) involved in the~     study will be matched on the company characteristics (e.g. company size, the industry the~     company belongs to). Using random generator in Excel, random number will be first generated~     to each pair i.e. there will be 1-40 random numbers. For each pair, the two companies will be~     randomly assigned to 0 or 1. Companies who are assigned to 1 will be allocated to~     intervention . Interviewers (assessors) in the follow-ups will not be involved in the~     randomization process and be totally blinded to the group assignment (allocation~     concealment).~      Invitation letter will be sent to beauty and retail industries or other women-related~     industries by Lok Sin Tong. Health talks on smoking and its hazard will deliver to each~     company. For those who join the workshops after the health talks will fill in pre- and post-~     workshop questionnaires (Appendix 4-5). Women who attend the health talk will be recruited on~     site. Women will be screened by the criteria of eligibility form (Appendix 1) and all~     eligible women smokers will be asked to sign on informed consents (Appendix 2, 3) before they~     participate in the programs. After they consent to participate, they will fill in a baseline~     questionnaire (Appendix 6), and will be assigned to intervention or control group according~     to the allocation of their company. Some of the eligible women may miss the health talks and~     directly join the intervention program, because of this situation the intervention group will~     be further divided into Group A and B: women in Group A will attend health talks and~     intervention program, women in Group B will only attend intervention program.~      Intervention group (Mindfulness Smoking cessation program): Women in intervention group will~     be provided 2 sessions mindfulness training within 2 weeks. Each session will last for 2~     hours with 8-20 participants. For mindfulness training, it aims to understand women smokers'~     own life planning, stressors and their correlation with smoking; to help women smokers sit~     with negative affect and alleviate stress through mindfulness; to educate women smokers gain~     the self-control and replace the smoking habit; to teach women smokers how to prevent craving~     and relapse. The tentative agenda is shown below:~      Session 1 (Introductory) Contents~        1. Pre-questionnaire~        2. Introducing mindfulness and managing craving with mindfulness~        3. Understanding the components of craving and its management~             -  The relationship between habitual response and learned association~             -  The physiological and psychological withdrawal symptoms~        4. Mindfulness yoga practices~      Responsible person* Smoking Cessation Program in Workplace (SCPW) staff & Yoga teacher~      Session 2 (Advanced)~      Contents~        1. Knowledge about impacts of smoking on women's health~        2. Recapture the management of craving through mindfulness~        3. Mindfulness exercises~        4. Mindfulness yoga practices~      Responsible person* SCPW staff & Yoga teacher~      * SCPW staff would be responsible for the whole session except for the part stress reduction~     and self-control through mindfulness yoga. It would be held by the yoga teacher.~      Control group (Self-help smoking cessation booklet): Only the self-help booklet related to~     quitting will be provided to the participants.~      Evaluation: 1-month telephone interviews will be conducted for control group at 1- (Appendix~     97) and 6-month follow-ups will be conducted for both groups (after the last interventions)~     by trained interviewers (blinded to the group assignment). Participants who have reported~     abstinence in past 7 days from smoking at 6-month follow-ups will undergo a non-biochemical~     validation to check their quitting status. They will be invited to have biochemical~     validation tests (saliva cotinine test and exhaled CO test) at 6-month follow-up.~      In-depth face-to-face interview will be conducted by trained interviewers in 10 randomly~     selected participants in each group (in total 20 participants) to better understand their~     quitting process, quitting difficulty, and their own feeling and experience in the project.~   "
81717|NCT02497326|"~     Pain Associated with partial thickness burns (PTB) is very severe and distressing for the~     patients.Topical conventional treatment of superficial PTB wounds includes application of~     polyfax skin ointment plus lignocain gel twice a day after wound wash while deep PTB are~     treated with silvazine cream twice a day and prepared for grafting if not healed within 3~     weeks. Existing conventional therapy is un-comfortable and expensive for the patients. Search~     continues for a reliable, safe, cheap and effective treatment of burn.Topical use of heparin~     has been found effective in reducing pain associated with burn wounds. More over use of~     heparin topically in burn patients is easy to perform and cheap but at the moment, evidence~     of its effectiveness is weak. Current study is being conducted to verify clinical~     effectiveness of use of heparin in 2nd degree burns by comparing it with topical conventional~     treatment.~   "
81718|NCT02497313|"~     Accumulating evidence suggests that bile acids in our intestines may constitute essential~     components in the complex mechanisms regulating gut hormone secretion and glucose~     homeostasis. Thus, it is likely that modification of the enterohepatic circulation of bile~     acids can lead to changes in gut hormone secretion and consequently affect glucose~     homeostasis.~      The current study is a human interventional randomized controlled cross-over study including~     four study days for each participant. Metformin will be applied as a tool to reduce bile acid~     reuptake in the small intestine; thereby increasing bile acid concentration in the more~     distal parts of the gut where GLP-1-secreting L cell are abundant. Interestingly, metformin~     has been shown to reduce the active reabsorption of bile acids in the ileum and cause~     increased faecal elimination of bile acids. Clinical data has suggested that metformin causes~     an increase in the postprandial secretion of GLP-1 in humans including patients with type 2~     diabetes. Intravenous infusion of cholecystokinin will be used to elicit gallbladder~     contraction and emptying. The aim is to examine how (and if) modification of bile acid~     reabsorption can influence postprandial glucagon-like peptide-1 (GLP-1) secretion and glucose~     homeostasis in patients with type 2 diabetes.~      The investigators hypothesize that higher luminal concentrations of bile acids in the distal~     gut will elicit changes in gut hormone secretion. The current study will help to clarify this~     hypothesis and improve our general understanding of the association between bile acid~     circulation and signalling, gut hormone secretion and glucose metabolism.~   "
81719|NCT02497300|"~     Vascular endothelial dysfunction increases cardiovascular (CV) risk and contributes to the~     progression of chronic kidney disease (CKD). Mineralocorticoid receptor (MR) antagonists have~     been shown to improve endothelial function, as well as decrease CV mortality and proteinuria.~     The specific biochemical pathways that produce these pharmacological effects for MR~     antagonists, however, are poorly understood. This study investigates the effect of MR~     antagonism on endothelial function in patients with moderate (stage III) CKD using a~     randomized, controlled trial. Three specific aims are proposed: Aim 1: To determine if~     spironolactone improves endothelial function as compared to amiloride in patients with stage~     III CKD; Aim 2: To determine if oxidative stress is associated with changes in endothelial~     function by spironolactone compared to amiloride in patients with stage III CKD; and Aim 3:~     To determine if endothelial dysfunction contributes to albuminuria in patients with stage III~     CKD. The clinical relevance is to improve understanding of the mechanisms of kidney function~     decline in CKD in order to develop interventions to delay or prevent dialysis, which would~     translate into alleviating patient suffering, caregiver burden, and health care costs.~   "
81720|NCT02497287|"~     The purpose of this open-label, multicenter study is to assess the long term safety and~     efficacy of intranasal esketamine plus an oral antidepressant in participants with~     treatment-resistant depression (TRD).~   "
81721|NCT02497274|"~     The purpose of the protocol is to determine the impact of bariatric surgery on taste~     receptors and taste perceptions and to precise the factors implicated in taste alterations in~     50 obese patients before and 6 months after bariatric surgery (25 Roux Y gastric bypass and~     25 sleeve gastrectomy).~   "
81722|NCT02497261|"~     The purpose of this study is to determine if avoidance of peanut by children with positive~     allergy testing to peanut in the first 5 years of life increases the likelihood of developing~     a persistent peanut allergy by age 5 years. To answer this question, the investigators need~     to determine which children with positive allergy testing to peanut have reactions after~     eating peanut (allergic to peanut) and which are able to tolerate eating peanut (not~     allergic).~      The investigators plan to conduct double-blind placebo-controlled peanut challenges (gold~     standard for peanut allergy diagnosis) for CHILD study (http://www.canadianchildstudy.ca)~     participants who had positive skin prick testing to peanut at ages 1, 3 or 5 years (in other~     words, children who are sensitized to peanut, but may or may not be allergic to peanut) and~     who are avoiding peanut without ever having had a reaction or whose history suggests that~     they may have outgrown a known peanut allergy. These challenges will not change a child's~     ability to tolerate peanut, but will determine if children who are avoiding peanut are~     allergic to peanut (and need to continue avoiding peanut) or clinically tolerant to peanut~     (and may continue to eat peanut after passing the challenge).~   "
81723|NCT02497248|"~     Currently available antiarrhythmic drugs for the treatment of atrial fibrillation (AF) have a~     limited efficacy and often cause long-term side effects. Pulmonary vein isolation is the~     therapy of choice in drug-refractory patients. Recent studies have shown that ablation have a~     greater efficacy in patients in whom AF is maintained hierarchically and after ablation of~     rotors. The non-invasive identification of specific mechanism of AF maintenance in each~     patient could allow the selection of the most appropriate treatment.~   "
81724|NCT02497235|"~     The purpose of this study is to determine the brain cholesterol 24S-hydroxylase (CH24H)~     enzyme occupancy of TAK-935 after single oral dose in healthy participants using the positron~     emission tomography (PET) ligand [18F]MNI-792 and PET imaging and to determine the~     relationship of occupancy to TAK-935 exposure.~   "
81726|NCT02497209|"~     Aim: To collate data on Anogenital Distance (AGD) from several population studies to build an~     international database for Anogenital Distance (AGD) Primary objective: To build a database~     platform to promote and facilitate international collaboration on research related to AGD,~     endocrine disruptors and reproductive health.~      Study Design Observational study Outcome Measures Outcomes from varying projects based on the~     database~      Summary of eligibility criteria Population studies with subjects in whom data on AGD is~     available~      Procedures:~      An international AGD database will be set-up with an appropriate dataset for the research~     projects. This will be based on anonymised data from multiple population studies. In order to~     facilitate and provide a governance structure for the study, an international AGD consortium~     will be established.~   "
81727|NCT02497196|"~     This study investigates comparing the effects of transcranial Pulsed Current Stimulation and~     transcranial Direct Current Stimulation (tDCS) (Soterix ©) and their combination on~     neurophysiological outcomes on healthy subjects as well as on the clinical population for~     chronic visceral pain. The study also aims to evaluate the effects of these techniques on~     pain thresholds in healthy subjects as well as for chronic visceral pain patients.~   "
81728|NCT02497183|"~     Acute appendicitis is the most common cause of abdominal pain requiring surgical~     intervention.~      The gold standard test for the diagnosis of acute appendicitis is the CT scan. Despite its~     effectiveness, the test involves exposure to a high dose of radiation.~      Using ultrasound to diagnose this condition has been described extensively in the medical~     literature, and this test has a very high specificity (over 95%), however sensitivity of the~     test is not as good and varies between 40% and 90%. Major limitations of the Ultrasound test~     include operator dependency as well as factors such as body habitus of the patient, presence~     of technical disturbances (artifacts) caused by gas in the large intestine and inadequate~     cooperation from the patient during the exam. All of these factors may affect the ability to~     detect sonographic signs of appendicitis.~      The investigators believe that it is possible to reduce the amount of artifacts caused by the~     presence of gas in the intestine by filling of the colon with liquid suspension that is~     routinely given in the investigators' hospital before performing an abdominal CT and~     performing an additional ultrasound scan to those patients in which the initial ultrasound~     examination (without any preparation) proved to be equivocal or not diagnostic.~      The target population for the study is any patient who arrives to the emergency room with~     complaints of right lower quadrant abdominal pain and it is decided by the referring~     physician in the ER to start diagnostic workup for suspected appendicitis by performing an~     ultrasound, if the ultrasound exam proves to be equivocal or not diagnostic and it is decided~     that the patient needs to continue investigation by performing a CT scan, the patient will~     receive contrast material orally for approximately 180 minutes and prior to the CT the~     investigators intend to repeat the ultrasound. The investigators hypothesize that the repeat~     ultrasound will allow a statistically significant improvement in the detection rate of the~     appendix.~   "
81729|NCT02497170|"~     Translational study based on the American Association of Diabetes Educators 7 behaviors to~     manage Type 2 diabetes~   "
81730|NCT02497157|"~     The purpose of this study is to evaluate the efficacy and safety of fluorouracil (5-FU),~     levofolinate calcium (l-LV), oxaliplatin (L-OHP) and irinotecan hydrochloride hydrate~     (CPT-11) (FOLFOXIRI) plus bevacizumab in untreated metastatic colorectal cancer patients who~     harbor Uridine diphosphate (UDP)-glucuronosyl transferase 1A1 (UGT1A1) *1/*1, *1/*6 or~     *1/*28.~   "
81731|NCT02497144|"~     Decreased exercise capacity and quality of life, increased dyspnea and fatigue perception and~     hypoxemia during exercise is seen in patients with interstitial lung disease. Impaired~     ventilatory response, increased lung compliance, ventilation-perfusion mismatching and~     inadequate peripheral circulation causes decreased exercise capacity. Another important~     factor that induce decreased exercise capacity is peripheral muscle weakness. In literature,~     there is no study investigated effects of neuromuscular electrical stimulation on functional~     exercise capacity, respiratory and peripheral muscle strength, pulmonary functions, physical~     activity level, dyspnea and fatigue perception in patients with interstitial lung disease.~   "
81732|NCT02497131|"~     This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and~     safety of Brentuximab Vedotin (BV) as a single agent in relapsed/refractory CD30+ PTCL~     patients.~   "
81733|NCT02497118|"~     This study mainly to observe the anti angiogenic drugs Endostatin (Endostar) combined with~     vinorelbine and Cisplatin (NP) as neoadjuvant therapy in patients with non small cell lung~     cancer clinical efficiency and safety. Through anti angiogenesis therapy combined with~     neoadjuvant chemotherapy improve the treatment of neoadjuvant therapy in tumor response rate~     and the rate of resection, At the same time, the study before and after the anti angiogenesis~     therapy in patients with peripheral blood circulation endothelial cells(CECs), levels of~     Endothelial progenitor cells（EPC）, micro vascular density（MVD） and vascular endothelial~     growth factor(VEGF) expression level, to understanding the correlation between the clinical~     efficacy of anti angiogenesis therapy combined with chemotherapy and the change of all these~     markers. In order to find the reference basis for the prediction of the effect of curative~     effect. The changes of blood volume, blood flow and vascular permeability of the lung cancer~     before and after treatment with CT perfusion imaging are studied.~   "
81734|NCT02497105|"~     This study will assess the effectiveness of the ketogenic diet (high-fat, low-carbohydrate,~     and moderate protein) in treating epilepsy. Two study groups will be comprised of children~     with epilepsy (0-18 years of age) and whether or not they receive the ketogenic diet -~     epilepsy/ketogenic diet and epilepsy/non-ketogenic diet.~   "
81735|NCT02497092|"~     The purpose of this study is to determine whether certain intravitreal injection techniques~     cause less pain than others and would therefore be beneficial for the patient's well being.~   "
81736|NCT02497079|"~     The purpose of this study is to compare the diagnostic efficacy of nested and realtime~     polymerase chain reaction for Mycobacterium tuberculosis using EBUS-TBNA samples in patients~     with isolated intrathoracic lymphadenopathy.~   "
81737|NCT02497066|"~     The main objective of this protocol is to determine the effectiveness of using compounded~     topical pain creams for treating neuropathic, nociceptive, or mixed-pain syndromes. Since~     these compounded pain creams may be associated with burning or irritation at the application~     site, and possible systemic effects may present, the secondary objective is to determine the~     relative satisfaction with the creams. The investigators hypothesis is that the active pain~     creams may provide significant benefit compared to placebo cream.~      3.1 Specific Aims~        1. Specific Aim 1 will determine pain relief following treatment with the appropriate~          (based on specified pain) compounded topical pain cream or a placebo cream. The~          investigators hypothesis is that the compounded topical pain creams will provide greater~          pain relief than placebo creams.~        2. Specific Aim 2 will measure the patient satisfaction with the cream (compound or~          placebo). The investigators hypothesis is that the compounded topical pain creams will~          improve patient satisfaction, while the placebo cream will not result in a change in~          patient satisfaction with their pain treatment.~   "
81738|NCT02497053|"~     The prognosis of mesothelioma is generally poor. The median survival of patients with~     unresectable malignant mesothelioma ranges approximately between 6-12 months. Survival is~     poor because there is no curative treatment.~      Treatment options include surgery, chemotherapy and radiotherapy. Recently multimodality~     treatment regimens have been reported to prolong survival. Other new therapeutic approaches~     include immunotherapy, gene therapy, hyperthermic chemoperfusion of the pleura and~     photodynamic therapy, but the results have not yet been completely validated. Even with the~     introduction of this new therapeutic protocol, the response does not exceed 41%, with a mean~     survival of 12 months. The current standard of care for unresectable malignant pleural~     mesothelioma is pemetrexed/cisplatin. This regimen was compared to cisplatin alone in a study~     including 448 patients from 19 countries which was the largest trial to date among patients~     suffering from malignant mesothelioma. Results showed statistically significant increase in~     overall survival by about 30 % (12.1 months for pemetrexed /cisplatin versus 9.3 months for~     cisplatin alone. In addition, there was an improvement in lung function (forced vital~     capacity) in the pemetrexed /cisplatin arm in comparison to the cisplatin arm.~      Until now, however, there is no consensus on the number of cycles of pemetrexed/cisplatin in~     malignant mesothelioma and there are no approved predictive markers for response.~      Pemetrexed/cisplatin regimen is an expensive regimen and associated with considerable~     toxicity and so we need to rationalize its use in our Egyptian patients.~      Therefore, the investigators aim in this work to compare 4 cycles versus 6 cycles of~     pemetrexed/cisplatin in malignant mesothelioma and to identify a predictive marker for~     response.~   "
81739|NCT02497040|"~     Ninety American Society of Anesthesiologists (ASA) Physical Status classification system I-II~     patients were recruited for a randomised, placebo-controlled, double-blind study and were~     randomly divided into three groups to receive either 20 ml of 0.5% bupivacaine (Group B;~     n=30), 20 ml of 0.5% levobupivacaine (Group L; n=30) or saline as a placebo (Group C; n=30).~     Scalp block was performed 5 min before head pinning. The primary outcome of the study was~     mean arterial pressure (MAP) and secondary outcomes were heart rate (HR), visual analogue~     scale (VAS) scores, additional intraoperative and postoperative drug use. Postoperative pain~     was evaluated using a 10-cm visual analogue scale (VAS).~   "
81740|NCT02497027|"~     This is a randomized, control group design of pharmacogenetic implementation in a mental~     health population of subjects taking anti-depressants and/or anti-psychotics with a new or~     current primary or secondary diagnosis of Major Depressive Disorder (MDD) or Depressive~     Disorder Not Otherwise Specified (DDNOS).~   "
81741|NCT02497014|"~     The objective of the study is to investigate clinical outcomes following single versus dual~     stenting strategies for the treatment of true bifurcation distal left main coronary artery~     lesions.~   "
81742|NCT02497001|"~     Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort®~     Turbuhaler® in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease.~   "
81743|NCT02496988|"~     The purpose of this study is to determine whether combining of Temozolomide and~     cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with~     Advanced Malignant Gliomas. The effectiveness and safety of CIK cells for the treatment of~     Malignant Glioma is also evaluated.~   "
81744|NCT02496975|"~     This is a prospective, randomized, placebo-controlled study about Cyclosporine A (CSP) and~     traumatic brain injury (TBI). Cyclosporine A is a drug already marketed and available for~     other diseases, but is not approved by the Food and Drug Administration for treatment of~     traumatic brain injury. The effect of Cyclosporine A on chemicals produced following brain~     injury is being determined using doses no larger than those used for patients having organ~     transplant. It is also being given for a much shorter time period (3 days). It is not know if~     side effects seen in patients taking cyclosporine A will occur when it is given for only 3~     days. It is not known if patients with brain injury that are treated with cyclosporine A will~     have side effects like those seen in organ transplant patients.~   "
81745|NCT02496962|"~     This study aimed to investigate the effect of 48-h sleep deprivation on heart rate~     variability (HRV) in young healthy people and the protective effect of statin on arrhythmia~     and HRV.~   "
81746|NCT02496949|"~     to assess the safety, tolerability，PK and efficacy profile of two doses (600mg,800mg,BID) of~     Icaritin in advanced solid tumor patients in China~   "
81747|NCT02496936|"~     The influences of specific dietary fat sources on satiety, appetite and energy utilization~     remains unclear; evidence is lacking on whether responses vary according to acute intake. The~     researchers will use a controlled setting to determine whether the source of dietary fat is~     related to perceived satiety, satiety hormone responses, and energy expenditure by conducting~     experiments to evaluate short term (acute) effects.~   "
81748|NCT02496923|"~     Background:~      High risk patients with lung disease who undergo cardiac surgery are at significant risk of~     postoperative complications leading to prolonged hospital stay. One method of reducing the~     risk of lung complications is to treat patients with non-invasive ventilation or continuous~     positive airways pressure postoperatively. However, this often requires admission to a high~     dependency unit or intensive care, and is uncomfortable because of the need for a tight~     fitting mask, as well as being labour intensive and costly. Nasal high flow oxygen~     (Optiflow™) is a new alternative as it provides warmed humidified oxygen at high flow, and~     also has been shown to assist breathing and improve recovery. It is comfortable during use~     and indeed may be more comfortable than standard (dry) oxygen via a facemask (Hudson type) or~     nasal prongs. It may be administered on a normal ward, however its routine use in high risk~     patients with lung conditions such as asthma, chronic obstructive pulmonary disease, recent~     chest infections and heavy smokers has not been tested before.~      Aims/Objectives:~      The primary aim of this clinical trial is to determine if prophylactic nasal high flow oxygen~     (Optiflow™) therapy in cardiac surgical patients at high-risk of developing post-operative~     pulmonary complications is associated with shorter hospital length of stay.~      Methods:~      High risk adult patients who are scheduled to undergo cardiac surgery will be recruited with~     full ethical approval and informed consent. Before surgery, each patient will perform a 6-~     minute walking test under the supervision of a physiotherapist. This simple tests measures~     how far patients can walk in 6 minutes. Additionally, patients will undergo spirometry~     testing which is used to assess how well the lungs work by measuring how much air the patient~     inhales and exhales and how quickly they exhale. Patients will thereafter undergo surgery~     under general anaesthesia as they would normally. After the operation they will be looked~     after following our recovery protocols, incorporating pain relief, regular physiotherapy,~     early mobilisation and eating and drinking, and removal of chest drains and tubes as soon as~     possible.~      On arrival in the critical care area after their surgery, patients will be randomly assigned~     to receive supplemental oxygen via a soft facemask (Hudson Type) (standard group), or via~     high-flow nasal cannulae(Optiflow™) (intervention group). Patients will be administered~     oxygen for at least 24 hours after surgery.~      Patients who develop breathing difficulty will receive treatment based on their clinical~     need. On the fifth or sixth postoperative day they will repeat the walking test and~     spirometry. The investigators will use a short questionnaire to determine if there is any~     difference in how patients feel they recovered before they leave hospital and how quickly~     they returned to normal activities after discharge, and also to evaluate how they tolerated~     either the facemask (Hudson Type) or high flow nasal cannulae (Optiflow™).~      The investigators have used data from previous studies to calculate that a total of 74~     patients will be needed to take part, in order to evaluate whether high flow nasal oxygen~     (Optiflow™) leads to reduced length of hospital stay after high risk cardiac surgery compared~     with usual care oxygen therapy.~   "
81749|NCT02496910|"~     This is a Randomized, open-label, single-dose, 2-treatment, 2-period, 2-sequence crossover~     design.~   "
81750|NCT02496897|"~     This study evaluates the safety and immunogenicity of FP-02.2, a new therapeutic Hepatitis B~     vaccine, administered as an add-on therapy to entecavir or tenofovir.~   "
81751|NCT02496884|"~     DS-5565 (mirogabalin) is being studied as treatment for fibromyalgia pain. Because it is~     excreted through the kidneys, people who have reduced kidney function will not process the~     drug as well as with those with normal kidney function, so the dose must be reduced. This~     study will test two reduced dose levels for both moderately reduced and severely reduced~     kidney function. The study will test the hypothesis that the drug will be safe and~     well-tolerated in people who have both fibromyalgia and chronic kidney disease.~   "
81752|NCT02496871|"~     The purpose of this study is to compare two different weight management delivery methods,~     social media versus a traditional care model.~   "
81753|NCT02496858|"~     The aim of this study is to identify genetic loci,or gene variations contributing to the~     development of coronary artery disease (CAD) in Chinese young adults. Investigators will~     compare coronary angiogram results to genetic findings within young CAD patients.~   "
81754|NCT02496845|"~     VL#FIA3-30 is a preparation intended for topical use, applied on the penis, for the treatment~     of ED.~   "
81797|NCT02496286|"~     This study will evaluate the safety and efficacy of intraperitoneal administration of~     Bevacizumab to prevent the recurrence of malignant ascites. Ten patients will receive~     intraperitoneal Bevacizumab 200 mg in 250 ml of normal saline for infusion every two weeks~     for up to six weeks, or a maximum of three treatments.~   "
81755|NCT02496832|"~     Researchers are looking for better ways of diagnosing and treating pancreatic cancer. It is~     believed that looking for low levels of oxygen (hypoxia) in tumours may give a better~     understanding of how certain tumours grow or respond to certain treatments. This study will~     look at hypoxia in pancreatic tumours while participants are receiving treatment with the~     combination of gemcitabine and TH-302/placebo in the EMR 200592-001 clinical research study.~      This study will use positron emission tomography (PET) scans to look at hypoxia in tumours.~     PET is an imaging test that can be used to measure hypoxia in tumours. For this study, a~     radioactive tracer called Fluoroazomycin Arabinoside (FAZA) will be used to label areas of~     hypoxia in tumours. Determining the levels of hypoxia in tumour tissue using FAZA-PET scans~     and comparing these levels with the patient's response to treatment with gemcitabine and~     TH-302/placebo for pancreatic cancer may help the researchers to determine the relationship~     between hypoxia and response to this treatment.~      The main purpose of this study is to see how useful looking at hypoxia in tumours are when~     they are done at different centres.~   "
81756|NCT02496819|"~     Children with Autism Spectrum Disorder (ASD) are increasing each year. There are about 1 in~     160 children for the age group of 6-12 years old in Australia are diagnosed with ASD.~     Children with ASD have impairment in two common areas including: i) social and communication~     and ii) repetitive and stereotypical patterns of behaviours. These common features result in~     behavioural problems which negatively impact children's participation in school, activities~     of daily living and social engagement.~      Therefore, there is a need for effective interventions to overcome the behavioural problems~     in children with ASD.~      The purpose of the study is to investigate the effect of sensory integration (SI) and~     self-regulated learning versus an activity-based control programme in reducing behavioural~     problems in children with ASD that interfere with their daily livings, school, and social~     engagement.~      The study will adopt a randomized controlled trial design with three intervention groups: I)~     self-regulated learning, II) sensory integration and III) activity-based intervention as the~     control group.~   "
81757|NCT02496806|"~     Brown seaweeds are a rich source of phlorotannins, a characteristic class of polyphenols~     which are unique to seaweeds of this type and can comprise 5 to 15 % of the dried weight.~     Unlike other classes of polyphenols, there is a lack of knowledge regarding phlorotannins and~     their bioavailability and bioactivity. The purpose of this study is to investigate the~     absorption and metabolism of seaweed polyphenols in humans. As part of an EC project~     (SWAFAX), an acute clinical intervention will be conducted to investigate the metabolism/~     bioavailability of brown seaweed phlorotannins. Urine and plasma samples from 24 healthy~     volunteers that consumed a seaweed capsule containing polyphenols will be collected before~     and after the intervention. Data emanating from this project will provide strong scientific~     evidence for bioavailability and health promoting activity of a seaweed polyphenol extract in~     human volunteers.~   "
81758|NCT02496793|"~     The goal of this community randomized operations research study was to evaluate the effect of~     a peer-facilitated community support group intervention on uptake of maternal and neonatal~     child health (MNCH) and PMTCT services and on adherence outcomes in Zimbabwe.~   "
81759|NCT02496780|"~     Insulin replacement therapy may be effective in breaking the cycle of protein catabolism,~     undernutrition and overall clinical deterioration in pre-diabetic, insulin insufficient CF~     youth because of its potent anabolic effect. A significant number of CF patients might~     benefit from this therapeutic approach with a substantial impact on morbidity and mortality.~   "
81760|NCT02496767|"~     This study is to assess the effect of tirasemtiv versus placebo on respiratory function in~     patients with ALS.~   "
81761|NCT02496754|"~     Pituitary down regulation is widely used during in vitro fertilization (IVF) procedures. It~     can suppress the spontaneous luteinizing hormone (LH) surge, and can also make follicles~     growth evenly.~      At present, standard gonadotropin releasing hormone analogue (GnRH-a) long protocol is used~     in around 85% patients in the investigator's center. However, patients have to inject short~     term GnRH-a 0.05mg or 0.1mg daily for around 3 weeks in one IVF cycle.~      Long term GnRH-a, which is usually used in patients with endometriosis,has been shown to~     increase IVF outcome by altering endometrial receptivity. Moreover, it is also very~     convenient because patients do not have to inject GnRH-a daily. In order to make patients~     feel more comfortable during IVF treatment, the investigators have used a new ovarian~     stimulation protocol since the beginning of 2015. The investigators give patients long term~     GnRH-a (3.75mg) once at menstrual cycle D2, and begin the use of Gn to stimulate follicle~     growth around 30 days later based on the hormone levels and follicle size. In the pilot~     observational study of several patients, no LH surge occurred during ovarian stimulation.~      The aim of this randomized controlled study is to compare the efficiency of this new protocol~     and standard GnRH-a long protocol in the investigator's center.~   "
81762|NCT02496741|"~     This phase Ib, open-label, single-center, non-randomized clinical trial will evaluate the~     toxicity and efficacy of metformin and chloroquine in isocitrate dehydrogenase 1/2-mutated~     (IDH1/2MT) patients with a glioma, intrahepatic cholangiocarcinoma or chondrosarcoma.~   "
81763|NCT02496728|"~     The purpose of the study is to investigate the preservation or promotion of health in~     students during the college years.~   "
81764|NCT02496715|"~     This is a pivotal trial that will examine therapeutic equivalence (BE) of a new generic~     fixed-dose combination product containing fluticasone propionate 100 mcg / salmeterol 50 mcg~     (as xinafoate salt) and reference listed drug (RLD) Advair® Diskus 100/50 in adult patients~     with chronic but stable asthma as defined in the National Asthma Education and Prevention~     Program Expert Panel Report 3 (NAEPP 3) guidelines~   "
81765|NCT02496702|"~     This study evaluates the use of Playware technology for balance training. Falling among elder~     is a costly problem. Research shows that training can help prevent falls. Pilot studies of~     the use of Interactive Modular Tiles (IMT) show that the participants can highly increase~     their physical abilities.~      The interventions group will train using interactive modular tiles. The tiles include~     preprogrammed games that create playful training for the participants.~      The control group will receive usual care, which here refers to normal day activities.~      The intervention will be done 2 times a week for 12 weeks, each session lasting 1 hour and~     each participant receiving 13 minutes of training each time.~   "
98492|NCT02278042|"~     The purpose of this study is to investigate the acute and chronic effects of consumption~     fructose containing sugars and glucose in a real word setting when consumed in a manner and~     amount typical in the American diet.~   "
81766|NCT02496689|"~     This clinical trial is being conducted in Hypophosphatasia, a bone disorder caused by gene~     mutation(s) resulting in bone defects. These gene mutations cause low levels of an enzyme~     needed to harden bone. The purpose of this study is to provide access to treatment in a~     disease where no approved treatment exists. This is an experimental treatment provided under~     specific treatment guidelines in which safety endpoints will be collected.~   "
81767|NCT02496676|"~     Background:~      - X-linked immunodeficiency with magnesium defect, Epstein-Barr virus infection, and~     neoplasia syndrome is called XMEN syndrome. In this genetic condition, the cells have less~     magnesium than normal. This makes it hard for the body to fight infections. Researchers want~     to see if magnesium supplements can make it easier for the body to fight infection.~      Objective:~      - To see if magnesium supplements can strengthen the immune system and reduce the amount of~     Epstein-Barr virus in people with XMEN syndrome.~      Eligibility:~      - People ages 6 and older who have XMEN syndrome~      Design:~        -  Participants will be screened with:~        -  Medical history~        -  Physical exam~        -  CT scan: Participants will drink a contrast and may get dye through an IV in the arm.~          They will lie in a machine that takes pictures of the body.~        -  EKG: Small sticky patches on the body will trace heart rhythm.~        -  Blood tests~        -  The study has 2 parts.~        -  Participants doing both parts will participate for 1 year and visit the clinic about 15~          <TAB>times. These visits will include a physical exam and blood and urine tests.~        -  Participants doing only the first part finish in 6 months and have fewer visits.~        -  For study part 1, participants will take magnesium pills for 3 months and placebo pills~          for another 3 months.~        -  At 3 and 6 months, they will have physical exam, medical history, blood and urine tests,~          <TAB>and an EKG.~        -  If the magnesium pills are not helpful, participants will do study part 2.~        -  They will be admitted to the hospital for 4 5 days to get magnesium for 3 days through~          an arm vein.~        -  They will take magnesium pills for another 6 months.~   "
81768|NCT02496663|"~     This phase I trial studies the side effects and best dose of necitumumab when given together~     with osimertinib in treating patients with EGFR-mutant non-small cell lung cancer that is~     stage IV or has come back (recurrent) and who have progressed on a previous EGFR tyrosine~     kinase inhibitor. Monoclonal antibodies, such as necitumumab, may block tumor growth in~     different ways by targeting certain cells. Osimertinib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Giving necitumumab with osimertinib may~     be a better treatment for EGFR-mutant non-small cell lung cancer.~   "
81769|NCT02496650|"~     The objective of this randomized controlled study was to evaluate whether DEX addition to~     benzodiazepine therapy is effective and safe for AWS patients in the intensive care unit~     (ICU). Eligible participants were randomly assigned to intervention (D) and control (C)~     groups. In the group D DEX infusion was started in doses 0,2-1,4 μg/kg/hr and titrated to~     achieve target sedation level; symptom-triggered BZD administration (diazepam 10mg bolus)~     were used wherever DEX infusion was not enough. In group K BZD boluses (diazepam 10mg) were~     used to achieve target sedation level and to control AWS symptoms (symptom-triggered~     administration). The primary efficacy outcomes were 24-hour diazepam consumption and~     cumulative diazepam dose required over the course of ICU stay, secondary outcomes were length~     of ICU stay, sedation and communication quality, haloperidol consumption.~   "
81770|NCT02496637|"~     The proposed study is a randomized clinical trial investigating the effects of a weight gain~     and eating dysregulation prevention intervention among college freshmen women. It will~     compare Appetite Awareness Training (AAT) to a standard nutritional education group and a no~     treatment control group. Appetite Awareness Training approach to increasing eating regulation~     through training individuals to eat in response to their appetite cues rather than external~     or emotional cues.~   "
81771|NCT02496624|"~     The Guided Therapeutics (GTx) program at the University Health Network is a network of~     clinicians, scientists, and engineers focused on the development and translation of~     image-guided technologies focused on minimally-invasive, adaptive therapies. Technologies~     developed within the GTx program include a portable intra-operative cone-beam CT (in~     collaboration with Siemens) that has been evaluated in clinical trials for head and neck~     surgery. The intraoperative imaging has been integrated with tracking and navigational tools~     and optical imaging to provide a general surgical dashboard that is used to improve the~     accuracy of surgical resection.~      A recent addition to the GTx program is the development of the GTx OR, located within the~     general operating room of the Toronto General Hospital. The GTx OR houses 2 complimentary~     advance technologies: the Siemens Zeego and the Siemens Somotom Flash CT. The dual-energy~     Somatom Flash provides a gold-standard in CT imaging, while the Zeego provides excellent 3D~     Cone-beam CT with robotic placement for flexible integration within the operating~     environment. Together, the integration of these 2 components into a single OR enables~     critical evaluation of the limits of CT imaging technology for surgical guidance.~      This study will be conducted using solely the Cone-beam CT (Zeego) for percutaneous placement~     and localization of markers for resection of small pulmonary nodules during VATS.~   "
81772|NCT02496611|"~     Long-term weight loss maintenance is seldom achieved by individuals with obesity owing to~     numerous biological adaptations involving appetite, satiety, and energy expenditure in the~     post- weight loss setting. Following a loss in body weight, peripheral and central mechanisms~     convey a sense that energy reserves have dwindled, activating a strong counter response to~     increase caloric intake. Adolescents with severe obesity are not immune to the vexing issue~     of weight regain. Indeed, only 2% are able to achieve and maintain clinically-meaningful~     weight loss with lifestyle modification therapy. Therefore, novel treatment paradigms focused~     on long-term weight loss maintenance are urgently needed. Pharmacotherapy has the potential~     to prevent weight regain by targeting specific counter-regulatory mechanisms in the post-~     weight loss setting. One of the most promising candidates is the glucagon like peptide-1~     receptor agonist (GLP-1RA) class, which greatly enhanced weight loss maintenance following a~     short-term low calorie diet among adults with obesity. The rationale for focusing on GLP-1RA~     treatment (BYDUREON™) to prevent weight regain is supported by the multiple central and~     peripheral mechanisms of action targeted by this class of drug; many of which specifically~     address the biological adaptations known to induce relapse. The investigators have strong~     preliminary data demonstrating that GLP-1RA treatment reduces BMI in adolescents with severe~     obesity. Moreover, the investigators and others have shown that although meal replacement~     therapy (structured meals of known caloric content) can elicit robust short-term weight loss~     among adolescents with severe obesity, weight regain is a pervasive problem. Therefore, in~     this clinical trial, our innovative approach will utilize GLP-1RA treatment to target weight~     regain following short-term meal replacement therapy in youth with severe obesity.~     Participants who achieve ≥5% BMI reduction during the meal replacement phase will be~     randomized to GLP-1RA treatment or placebo for an additional 52 weeks while simultaneously~     engaging in lifestyle modification therapy. Importantly, this study will also allow us to~     examine the extent to which GLP-1RA treatment addresses mechanisms of weight regain,~     investigate other pleiotropic benefits of GLP-1RA, and identify predictors of weight loss~     response.~   "
81774|NCT02496585|"~     The purpose of this study is to find out what effects, good and/or bad, the drug nintedanib~     in combination with steroids, has on the lungs. Furthermore, such treatments' side effects~     will be studied together with quality of life. In addition, the investigators would like to~     determine whether they can find markers in the blood which predict worsening lung injury.~   "
81775|NCT02496572|"~     Multidrug resistant tuberculosis (MDR TB) is a growing problem and few people have access to~     adequate diagnosis and treatment. The current recommended treatment regimen for MDR TB has a~     minimum of 20 months duration with high toxicity. Scale up of MDR TB treatment is associated~     with high default rates, and experience in the Medecins Sans Frontieres (MSF) programme in~     Uzbekistan shows that the current standard treatment greatly limits the ability to scale up~     to meet the high rates of MDR TB in the region.~      Evidence from Bangladesh in 2010 showed that a 9-month short-course regimen could achieve a~     relapse-free cure rate of 88%. Several countries in West Africa started implementing similar~     regimens with similar outcomes. Evidence of effectiveness of this shortened regimen among~     regions with high second line drug use and resistance is still limited.~      The investigators propose an observational study under programmatic conditions to evaluate~     the effectiveness of a shortened course MDR TB regimen in the high MDR/extensively drug~     resistant (XDR) TB prevalence and high second-line drug resistance setting of Karakalpakstan,~     Uzbekistan.~   "
81776|NCT02496559|"~     Viral self-limiting infections in respiratory organs among children are common in primary~     care. Serious infections have low prevalence and are challenging to distinguish from~     self-limiting infections.~      Prescription of antibiotics in primary care is still high but stable since 2009 in Norway,~     and 90% of all antibiotics are prescribed in primary care.~      C-reactive protein (CRP) has been especially popular in Norway for point-of-care testing in~     primary care, but its role in ruling-out serious infections and the cut-off value for~     prescribing antibiotics has been discussed a lot.~      The aim of this study is to identify if pretesting with CRP of all children 0-6 year with~     fever or respiratory symptoms at Out-of-Hours Services will affect the prescription of~     antibiotics and the referral to hospital for children.~   "
81777|NCT02496546|"~     The aim of this trial is to assess the efficacy of LEO 32731 cream 20 mg/g compared with LEO~     32731 cream vehicle in adults with mild to moderate AD after 3 weeks of treatment.~   "
81778|NCT02496533|"~     This clinical trial design evaluates whether hand massage reduces anxiety levels in cancer~     patients as they undergo radiological examination to evaluate tumor response. Anxiety levels~     will be investigated before massage, after massage, and following the completion of the~     radiological exam. The Visual Analog Scale (VAS), a validated anxiety assessment tool, will~     be used to measure anxiety.~   "
81779|NCT02496520|"~     Phase I/II, open, prospective clinical trial, historically controlled. The objective is to~     evaluate the safety and, as a secondary measure, the efficacy of an experimental treatment~     based on a cellular therapy (vaccination with autologous dendritic cells pulsed with tumor~     lysate) in patients affected of metastatic or relapsed sarcomas or (Central Nervous System)~     CNS tumors.~   "
81780|NCT02496507|"~     The purpose of this study is to investigate whether a device that allows office workers to~     sit or stand whilst working can reduce their sitting time at work and improve their health~     over 8 weeks.~   "
81781|NCT02496494|"~     The purpose of this study is to evaluate the effects of conversion from cyclosporine to~     tacrolimus on the changes of cardiovascular risk profiles and serum metabolites in renal~     transplant recipients.~   "
81782|NCT02496481|"~     This study involves an emergency department (ED)-based intervention utilizing Motivational~     Interviewing (MI) techniques and patient-centered (e.g., tailored) print materials to promote~     the correct and consistent use of size-appropriate child passenger restraints (car seats,~     booster seats, and seat belts). This study is designed as a randomized pilot trial.~   "
81783|NCT02496468|"~     Despite its common occurrence, still little is known about pathomechanisms determining~     different wheeze and asthma trajectories and phenotypes in children, and those beginning in~     adulthood. Therefore, deciphering underlying determinants for different childhood and adult~     asthma phenotypes is urgently needed to develop personalized treatment approaches targeting~     distinct underlying mechanisms. Thereby, secondary prevention early in the disease process~     can also be achieved. The decoding of such mechanisms and their translation to the individual~     patient is the aim of the Disease Area Asthma Allergy of the 'German Centre for Lung~     Research' (DZL).~   "
81784|NCT02496455|"~     The purpose of this study to determine the association between postoperative pain after~     cesarean section and several single nucleotide polymorphisms in SCN9A sodium channels gene.~   "
81785|NCT02496442|"~     A. Synopsis~        1. This protocol comes to direct the experiment to be performed on the Aqueduct Automatic~          Continuous Irrigation system.~        2. The Aquaduct System is aimed at reducing risks to the patient by decreasing the~          irrigation fluid pressure he may be exposed to, reducing the procedure time and~          therefore the anesthesia time, reducing the manual handling of the sterile bags and the~          risk of contamination and more.~        3. In general since there is no new procedure suggested and the equipment does not actually~          come into contact with the human body in any direct way, there is no need to have a~          clinical study for the regulation purpose. The reason for performing this experiment is~          to demonstrate the new system and to find out the best way to operate it in order to~          improve the process and reduce risks.~        4. This information will serve the development of most suitable automation solution for~          achieving the long desired continuous irrigation.~        5. The experiment will be performed in the OR in MIS procedures, and will replace the~          standard gravitational manual method of performing the irrigation. The surgeons and the~          medical staff of the OR will be directed with the set up and operation of the system~          prior to using it. The experiment will be accompanied at all times with a knowledgeable~          representative of the research originator.~        6. A maximum of 30 procedures will be analyzed during a period of approximately one month.~          The surgeons and the medical staff will report their impression of using the system~          during the procedures and will recommend the best settings achieved.~      This information will be used to improve the system performance and design.~   "
81798|NCT02496273|"~     The purpose of this study is to evaluate the clinical safety and preliminary efficacy of CEA~     specific cytotoxic T lymphocytes induced by dendritic cells infected by recombinant~     adeno-associated virus with CEA gene in the treatment of stage IV gastric cancer patients.~   "
81786|NCT02496429|"~     The primary objectives of this study is to evaluate how professionals rate the reliability~     and usability of the reusable BrownieForSymphony pump set.and the current used Symphony pump~     set~      4.2 Secondary Objectives~      The secondary objectives of this study are:~        -  to evaluate the rate of usability problems with the BrownieForSymphony pump set~        -  to evaluate the pragmatic quality (task/goal fulfilment) of the BrownieForSymphony pump~          set~        -  to evaluate first impression of lactating woman regarding pumping with the~          BrownieForSymphony pump set~   "
81787|NCT02496416|"~     This study will examine the effectiveness of aquatic therapy on a range of MS-related~     symptoms such as cognition, mood, fatigue and quality of life (QOL).~   "
81788|NCT02496403|"~     This is a randomized trial of two group-based models of care for buprenorphine/naloxone~     (bup/nx) patients in Substance Use (SU) specialty treatment: Standard Medical Management~     (SMM) and Intensive Outpatient Treatment (IOT). The setting is a large outpatient SU~     treatment program, where a medical management model of care has not been empirically tested~     with bup/nx patients, and where a high prevalence of patients with co-occurring psychiatric~     and medical co-morbidities are treated. SSM includes brief weekly group-based visits~     consistent with previously studied medical models, and is drawn from primary care bup/nx~     research. IOT is a predominant model of care in specialty treatment, and incorporates~     psychosocial support, 12-step, educational and relapse-prevention based approaches. The~     investigators will recruit 300 adult patients inducted onto bup/nx, randomize them to either~     SMM or IOT, and conduct telephone follow-up interviews at 6 and 12 months. Study~     investigators will examine the impact of these treatment approaches on 90-day bup/nx~     adherence, opioid and SU abstinence, quality of life, and health care and societal costs.~     Further, investigators will examine whether the effect of IOT versus SMM on adherence and SU~     treatment outcomes is greater for those with medical or psychiatric co-morbidities. This~     innovative approach includes a focus on complex patients with psychiatric and medical~     co-morbidities in specialty care, adapting a care model previously only tested in primary~     care, a 12-month follow-up, no research-forced medication taper, an examination of health~     care and societal costs, and a combination of patient self-report and electronic medical~     record data. Through this approach, the proposed study will yield critically important~     findings on how best to treat complex prescription opioid dependent patients with an~     integrative behavioral services and medication treatment model in SU treatment.~   "
81789|NCT02496390|"~     Non-alcoholic fatty liver disease (NAFLD) occurs when excess fat is deposited in the liver.~     Almost all patients also have obesity and insulin resistance (the inability of the body to~     effectively use insulin). Obesity and NAFLD are intricately intertwined and are increasing in~     incidence. While weight loss is the most effective therapy for NAFLD, the investigators'~     efforts are failing and in the next generation it will become the most common cause of liver~     failure in Canada. Recently, researchers have focused on the potential use of altering the~     composition of bacteria in the gut (microbiome) to alter absorption of energy from food,~     deposition of fat and resistance to insulin. This study will determine if transplantation of~     bacteria from the stool of a healthy volunteer into an individual with metabolic syndrome and~     NAFLD (i.e. fecal microbiota transplant/FMT) can alter insulin resistance and reduce the~     amount of fat deposited in the liver. FMT is being studied to treat several clinical~     conditions and is now standard of care for the treatment of refractory Clostridium difficile~     infection. Investigators are proposing a randomized controlled pilot study of FMT in 21~     patients to determine the feasibility and to inform us of changes needed for a larger study.~   "
81790|NCT02496377|"~     Patients were recruited at the scheduled preoperative visit for hip or knee arthroplasty. If~     the haemoglobin (Hb) level was below 13 g/dl with no contraindication to iron supplementation~     the patients were randomized to the oral or intravenous (IV) group. The oral group received~     160 mg ferrous glycine sulfate daily during the month prior surgery, associated with 3~     epoetin alpha (EPO) injections (40 000 IU subcutaneous on day - 21, day - 14 and day-7). The~     IV group received ferric carboxymaltose 1000 mg IV in 15 minutes one month before surgery,~     associated with 3 EPO injections. Primary efficacy endpoint was the change in Hb level from~     the day of the preoperative visit to the day before surgery (day-1). Secondary endpoints~     comprised the Hb level on day 3 and 5 after surgery, allogenic transfusion during and after~     surgery, and the change in iron indices from the day of the preoperative visit to day - 1.~   "
81791|NCT02496364|"~     Lumbar degenerative disease surgery entails in a high blood loss, requiring often for blood~     transfusion. The cost and risks involved in the use of allogeneic blood have motivated~     research methods to reduce operative bleeding in these patients. One such method is the use~     of anti-fibrinolytic drugs, among which is tranexamic acid.~   "
81792|NCT02496351|"~     A growing body of literature indicates that up to 80% of amputees may have phantom limb pain~     (PLP). The first cause for limb loss is vascular disease. Usually, amputees who suffer from~     PLP are suboptimal treated. Therefore, many amputees are disabled by their chronic pain. The~     etiology and pathophysiology of PLP are poorly understood. Some studies suggest a~     somatosensory cortex reorganization. Transcutaneous Electrical Nerve Stimulation (TENS) is a~     analgesic technique. TENS apply a low voltage electrical current through the skin using~     surface electrodes in order to stimulate afferent nerve fibbers. Because of the lack of~     evidence to support any treatment for PLP, interest has turned to preventing it instead.~      The aim of this study is to assess if the early use of TENS in the immediately postoperative~     of major limb amputation due to peripheral vascular disease, should decrease the PLP~     incidence. TENS should interfere in the mechanism of PLP production to level of the pain~     fibers conduction.~   "
81793|NCT02496338|"~     The investigators conducted a clinical trial to evaluation the effect of a menopausal health~     training for Husbands of 45-60 years women on the women's quality of life and marital~     satisfaction during transitional period to menopause.~   "
81794|NCT02496325|"~     Objective: Description of a new transperineal technique of pudendal nerve block (PNB), under~     ultrasound-guidance.~      Methods : Successive inclusions after parental consent of 60 children undergoing perineal~     surgery under general anesthesia and pudendal nerve block. Data were collected from induction~     of anesthesia to second post-operative day (24 hrs. after admission in recovery room). Ease~     of PNB achievement was the primary objective evaluated. Efficiency in preoperative and~     postoperative period was also reported.~   "
81795|NCT02496312|"~     The purpose of this study is to provide relevant quantitative evaluation of apathy close to~     real life situation by means of a multimodal sensor system integrated.~   "
81796|NCT02496299|"~     It is a prospective double blind randomized study on the effect of dexamethasone added to~     bupivacaine with plain bupivacaine for caudal block in patient for herniotomy.~      96 patients between the ages 1-6 years will be randomly selected and divided into two groups;~     B and BD.~      Group B will receive 1ml/kg bupivacaine 0.25% (maximum volume 20mls) and group BD will~     receive a mixture of 0.2mg/kg dexamethasone in 1ml/kg bupivacaine 0.25% (maximum volume =~     20mls).~      Data taken will then be analyzed and interpreted.~   "
81799|NCT02496260|"~     Radiotherapy plays an integral role in breast cancer therapy. Multiple randomized studies~     have demonstrated decreased local-regional recurrence rates and decreased breast-cancer~     mortality. However, balanced with this survival benefit is the potential toxicity of the~     treatment itself. In particular, cardiac effects of radiotherapy have been a concern and an~     area of research for the past 20 years. From long-term follow up of patients with lymphoma,~     it is known that radiotherapy can lead to increased risk of myocardial infarction, valvular~     dysfunction, systolic and diastolic function abnormalities, and heart failure among~     cancer-survivors. Patients with breast cancer receive lower doses to smaller volumes of the~     heart, but they also have an excellent long-term survival, so it is crucial to study the~     effects of low dose radiotherapy. Indeed, a recent study suggests that these effects can be~     seen within the first 5 years after treatment, and that there is no dose threshold. This~     study aims to develop imaging and blood biomarkers of cardiac exposure, as a first step to~     identifying patients at increased risk for cardiac effects, so they can be targeted for close~     monitoring and early intervention, potentially with statins or ACE inhibitors. Additionally,~     by characterizing a time-course and radiation dose-volume relationship, potentially real-time~     modifications can be made to RT field design for patients sensitive to RT effects. Finally,~     this information can be incorporated into better designs of treatment plans for future~     patients.~   "
81800|NCT02496247|"~     This study will test the effectiveness of a weekly village distribution of canned herring for~     prevention of malnutrition in children aged 2-5 years old during a food-insecure time of the~     year in rural villages in Guinea-Bissau. The study will use community health workers to~     conduct the herring distribution, making this a test that will provide valuable information~     on what could become a practical food aid supplementation practice. The primary study~     hypothesis is that distribution of canned herring as a weekly food supplement to families~     with young children at the beginning of the rainy season will prevent a seasonal decrease in~     weight-for-age Z-score (primary variable) of children with mild to moderate malnutrition at~     baseline.~   "
81801|NCT02496234|"~     Cardiac surgery associated acute kidney injury (CSA-AKI) has been recognized as the second~     most common cause of hospital acquired AKI. The development of CSA-AKI is independently~     associated with an increased risk of in-hospital death. There are currently no biomarkers~     that could identify patients at higher risk for AKI and current risk predictor scores that~     are based on clinical and demographic information are inadequate. Therefore, a diagnostic~     test for predicting AKI risk in this clinical context would assist clinicians to optimize~     surgical strategy and postoperative care to prevent CSA-AKI occurrence and improve patient~     outcomes.~      The primary purpose of this study is to measure the association between baseline expression~     of senescence markers in blood using SenesceTest and the occurrence of CSA-AKI post surgery.~   "
81802|NCT02496221|"~     Albiglutide, a novel analogue of glucagon-like peptide-1 (GLP-1), has been developed and~     approved for the treatment of type 2 diabetes mellitus. The primary objective of this study~     is to assess if a single dose of albiglutide can affect cholecystokinin-induced gallbladder~     emptying. To make this assessment, each study participant will receive a dose of albiglutide~     and a dose of placebo followed by cholecystokinin (CCK) infusion and ultrasound measurement~     of the gallbladder.~      The study will be comprised of two periods and 20 subjects. The screening visit will occur~     within 42 days of the start of Treatment Period 1. The Treatment Periods will be separated by~     a washout period of a minimum of 42 days. Subjects will return for a follow-up visit after 28~     days following the last dose of albiglutide or placebo. The total duration of a subject's~     participation from Screening to Follow-up will be approximately 17.5 weeks.~      This study is a post marketing commitment to the United States Food and Drug Administration~     (USFDA).~   "
81803|NCT02496208|"~     This phase I trial studies the side effects and best doses of cabozantinib-s-malate and~     nivolumab with or without ipilimumab in treating patients with genitourinary (genital and~     urinary organ) tumors that have spread to other places in the body. Cabozantinib-s-malate may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~     Monoclonal antibodies, such as nivolumab and ipilimumab, may block tumor growth in different~     ways by targeting certain cells. It is not yet known whether giving cabozantinib-s-malate and~     nivolumab alone or with ipilimumab works better in treating patients with genitourinary~     tumors.~   "
81804|NCT02496182|"~     The Chronic Hypersensitivity Pneumonitis (HP), is an inflammatory disease who has an~     evolution to develop progressive interstitial fibrosis, who cause the death of the patient.~     Actually HP has been treated with Prednisone and occasionally with Azathioprine, but~     unfortunately the treatment with these drugs have not an effective result to treat the~     interstitial fibrosis.~      Pirfenidone has been studied over the world for the treatment of Fibrotic diseases, with~     positive results, and due to the Pirfenidone mechanism of action has anti-inflammatory and~     anti-fibrotic properties, the investigators propose to evaluate the addition of Pirfenidone~     to the actual treatment with Prednisone and Azathioprine in the treatment of patients with~     Pulmonary Fibrosis secondary to a Chronic Hypersensitivity Pneumonitis.~   "
81805|NCT02496169|"~     The purpose of this study is to evaluate the safety and efficacy of the eucaLimus Sirolimus~     Eluting stent system in patients with de novo coronary lesions.~   "
81806|NCT02496156|"~     This work is testing a shared medical decision making intervention for adolescents with type~     1 diabetes and their parents who are candidates for adding either an insulin pump or~     continuous glucose monitor to their treatment plan. The first half of the work consisted of~     the stakeholder driven design, construction and refinement of web-delivered multimedia~     decision aids for each of these decisions. The randomized controlled trial of that~     intervention began enroling participants in February 2015. A sample of 166 eligible~     adolescents who receive care at an operating entity of the Nemours Children's Health System~     will be enrolled and randomized to either Usual Clinical Practice alone or augmented by the~     Shared Medical Decision Making intervention. Primary outcomes include measures of engagement~     with the pertinent technology if it is chosen and measures of decision quality; Secondary~     outcomes include indices of metabolic control, quality of life and parent-adolescent~     relationships around diabetes management.~   "
81807|NCT02496143|"~     The purpose of this study is to determine if EC-18 is safe and tolerable in healthy subjects.~   "
81808|NCT02496130|"~     The goal of this study is to compare common methods of tissue extraction at the time of~     minimally invasive surgery.~   "
81809|NCT02496117|"~     Study design: Investigator initiated, single centre, feasibility study~      Main objectives are twofold:~        1. To investigate the feasibility of RNS in patients with therapy resistant hypertension,~          which is assessing the functional distribution of renal nerves using 3D imaging and~          differential pacing modalities.~        2. To investigate the blood pressure responses and cardiac excitable properties to RNS, and~          subsequently perform a RDN procedure, guided by 3D mapping by two different techniques~          e.g. RNS-checked RDN and RNS-guided RDN procedures.~      Study population: 40 patients (18 - 80 yr old)~   "
81810|NCT02496104|"~     Each year in France, 7 % of newborns are born preterm (before 37 weeks of gestational age~     (GA)). The investigators called very preterm infants those who were born before 33 weeks of~     GA. These very preterm infants have a higher risk of developing neurological complications~     like developmental disabilities or cerebral palsy. To date, early assessment of these infants~     is difficult and not reliable enough to detect those who are at risks of developing~     neurological issues. Now, the investigators need to identify earlier these infants to provide~     them interventions to improve their development (physical therapy for example). Consequently,~     the investigators are examining a study whose aim is to assess preterm infants habituation.~     Habituation is the newborn ability to become familiar with new environmental stimulations~     (noise, light…). This habituation allows the newborn to maintain his sleep even at onset of a~     noise or light. To study this phenomenon in infants born preterm near to corrected term~     (around 40 weeks of postnatal GA), will allow us to better understand neurological~     development of these infants. The investigators plan to compare habituation skills of preterm~     infants near to their theorical date of birth (40 weeks of GA) to a population of infants~     born at term. The investigators will also study the link between habituation abilities and~     sleep quality as well as neurodevelopmental outcome at the corrected age of two years old.~   "
81811|NCT02496091|"~     The study is designed as a retrospective and multi-center study. The study population is US~     individuals previously restored with titanium and gold-shaded titanium ATLANTIS abutments.~     The study includes retrospective data collection from the medical records and data collection~     from one prospective study visit with a clinical examination.The primary objective is to~     evaluate success. Success is defined as that the study implant and abutment are in situ and~     no Adverse Device Effects related to the study implant, abutment or adjacent peri-implant~     tissues are reported during the study.~   "
81812|NCT02496078|"~     The purpose of this study is to determine whether a regimen consisting of daclatasvir and~     asunaprevir is effective in treatment-naive patients with chronic hepatitis genotype 1b~     infection.~   "
81813|NCT02496065|"~     Surgery is the primary treatment modality for many types of cancer and the extent of surgical~     resection is directly related to patient survival. However, it is often difficult for~     surgeons to distinguish normal from neoplastic tissue or to detect metastatic disease or~     tumor-infiltrated lymph nodes. In some sites, surgical precision is also required to avoid~     damage to critical normal tissues. The purpose of this exploratory study is to evaluate the~     intra-operative and ex vivo fluorescence of BLZ-100 in tumor samples from subjects with~     breast cancer.~   "
81814|NCT02496052|"~     To estimate the efficacy and safety of dried biological amnion graft after hysteroscopic~     lysis of intrauterine adhesions.~   "
81815|NCT02496039|"~     6 month study of NUEDEXTA ® (Dextromethorphan Hydrobromide and Quinidine Sulfate) for the~     treatment of Pseudobulbar Affect (PBA) in Nursing Home Patients.~   "
81816|NCT02496026|"~     The objective of the study is to evaluate the effectiveness of transcranial direct current~     stimulation (tDCS) integrated with wrist robot-assisted treatment. In detail, the anodal~     stimulation on the impaired hemisphere will be used associated with a robotic treatment.~   "
81817|NCT02496013|"~     This is an open-label whole-body PET/CT study for investigation of radiation dosimetry,~     plasma pharmacokinetics, biodistribution, safety and diagnostic performance of 68Ga-NEB in~     healthy volunteers and patients with suspected infection. Changes of routine blood and urine~     tests and any adverse events will be collected from the volunteers. Adverse events will also~     be observed in the patients.~   "
81818|NCT02496000|"~     Randomized, double-blind, placebo-controlled, parallel group study.~   "
81819|NCT02495987|"~     This study aims to understand the role of metabolic tissues in the changes of the metabolism~     of pregnant women and whether this contributes to some women developing metabolic diseases of~     pregnancy such as gestational diabetes (GDM) or intrahepatic cholestasis of pregnancy (ICP).~     Samples of adipose tissue will be taken when pregnant women are having caesarean section or~     laparoscopic procedures.~   "
81820|NCT02495974|"~     The purpose of this study is to evaluate the effectiveness of enzalutamide in patients with~     metastatic castration resistant prostate cancer (mCRPC) in the clinical practice setting as~     measured by time to treatment failure defined as the time from baseline (treatment~     initiation) to treatment discontinuation of enzalutamide for any reason including disease~     progression, skeletal related events, treatment toxicity, patient preference, or death.~   "
81821|NCT02495961|"~     The prevalence of obesity and type 2 diabetes mellitus (DM) in children have been increasing~     in parallel at an alarming rate. In particular, the increasing prevalence of type 2 DM is~     attributable to genetic factors, clinical (waist circumference, adiposity and physical~     condition) and biochemical (insulin secretion and sensitivity, lipids and inflammation) risk,~     each of which represents an independent risk.~      As has already studied and published in the investigators' group, the child population of~     Toluca has greater expression of cardiovascular risk factors than their counterparts in~     Bogota, Colombia. The metabolic characterization of the young population of Toluca and Bogota~     with new biomarkers such as homocysteine and leptin is an activity that aims to provide more~     metabolic data affecting young people.~      Hypothesis:~      After six months of follow-up there will be a greater relative risk in Mexican population to~     have identified another component of metabolic syndrome compared to the young population of~     Colombia.~   "
81822|NCT02495948|"~     The purpose of this study is to evaluate cholesterol sorption by AIR OPTIX® AQUA lenses~     compared to ULTRA lenses after 30 days of wear.~   "
81823|NCT02495935|"~     This is a prospective, randomized, parallel group sham-controlled blinded clinical trial to~     assess the feasibility and efficacy of transcorneal electrical stimulation (TES) in the~     improvement of visual function outcomes in adults with amblyopia. The trial will assess the~     treatment effect of TES to Sham TES in the amblyopic eye of affected patients.~   "
81825|NCT02495909|"~     Objective and Hypotheses: This project has the overall objective of implementing and~     evaluating new approaches to reducing the current and future burden of urinary~     schistosomiasis in young children using the antihelminthic drug Praziquantel. The project~     aims to (1) determine the operational health benefits of treating schistosome infections~     early on re-infection and morbidity reduction, (2) determine if gut or urine microbiome~     structure (species diversity or abundance) is a risk factor for S. haematobium infection or~     morbidity, and (3) elucidate the factors and underlying mechanisms mediating the~     reduction/reversal of schistosome-related morbidity and resistance against~     infection/re-infection in young children.~   "
81826|NCT02495896|"~     This pilot phase Ib trial studies the side effects and best dose of recombinant EphB4-HSA~     fusion protein when given together with standard chemotherapy regimens in treating patients~     with solid tumors that have spread to other places in the body and usually cannot be cured or~     controlled with treatment (advanced) or have spread to other places in the body (metastatic).~     Drugs used in chemotherapy, such as recombinant EphB4-HSA fusion protein, paclitaxel~     albumin-stabilized nanoparticle formulation, gemcitabine hydrochloride, docetaxel, and~     cisplatin, work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. It is not yet~     known whether standard chemotherapy regimens are more effective with recombinant ephB4-HSA~     fusion protein in treating advanced or metastatic solid tumors.~   "
81827|NCT02495883|"~     Essential Tremor (ET) is the most common tremor disorder, currently affecting an estimated~     2.9 million Americans and leading to disability and decreased quality of life in 75% of~     cases. The pathophysiology of ET is poorly understood, with the source of the tremor~     remaining controversial since all studies show increased activity in the cerebellum~     (including mimicked tremor in controls), while animal models of ET using harmaline and a~     single human PET study implicate the inferior olivary nucleus in the brainstem.~      There is evidence from the investigator's laboratory that the use of resting-state functional~     magnetic resonance imaging (rs-fMRI) is useful for characterizing the abnormal tremor neural~     network in ET compared with controls. The goal is to identify the source of the tremor, which~     is hypothesized to remain active during rest.~      Current ET diagnostic criteria require the presence of postural and/or kinetic tremor, which~     are assumed to be different manifestations of the same tremor oscillator. This long-standing~     assumption may be incorrect based on several lines of evidence from the investigator's~     laboratory, and has major implications for understanding ET pathophysiology and treatment.~     The investigators will test the hypothesis that postural and kinetic tremors are generated~     through different neural mechanisms.~      Treatment of ET focuses on pharmacological agents of various mechanisms and rarely deep brain~     stimulation of the Vim thalamus. Despite the assortment of agents used to treat ET, only ~50%~     of patients benefit from a particular agent. Furthermore, the mechanisms of action on tremor~     are not generally known. Understanding the mechanisms of action of various tremor-suppressing~     agents is critical for future drug development. In this proposal, the investigators plan to~     study the effects of ethanol (the most efficacious tremor-suppressant currently available)~     and propranolol (a non-specific β-adrenergic blocker with proven efficacy and unknown~     mechanism of action) on the tremor neural network.~   "
81828|NCT02495870|"~     Cooking meat at low temperatures for prolonged times is widely used among chefs and in food~     service due to the possibility to obtain a consistent and appealing eating quality. The~     method is generally termed low-temperature long-time (LTLT) cooking. In LTLT cooking, meat is~     vacuum-packed and heated at temperatures between 50°C and 65°C in a water bath for several~     hours. LTLT has several benefits - improved tenderness and juiciness, less cooking loss,~     better vitamin retention and uncompromised food safety.~      A recent PhD thesis concluded that one of the mechanisms behind the changes in eating quality~     during LTLT cooking was due to the proteolytic degradation in the muscle tissue. The activity~     of proteolytic enzymes has shown to be dependent on heating temperature and time where the~     cathepsins were found to remain active during heat treatment. At 58°C the cathepsin B+L~     activity is increased compared to 48°C and 53°C and at 55°C compared to 25°C, 40°C and 70°C.~     A prolonged heating time of 17 hours at 58°C has also shown to increase cathepsin B+L~     activity. The proteolytic degradation results in the occurrence of peptides and amino acids~     such as tryptophan, tyrosine, leucine and histidine which could lead to a faster degree of~     satiety when consumed.~      According to the aminostatic hypothesis by Mellinkoff, a rise in plasma amino acids elicited~     by protein ingestion could assist in the suppression of food intake and the onset of satiety.~      The investigators therefore hypothesize that the ingestion of LTLT cooked pork would induce a~     faster satiety response due to the higher availability of peptides and amino acids prior to~     digestion. An acute meal study will elucidate this. LTLT cooking will be performed by the~     cook-chill method to mimic real life where meat is rapidly chilled after heat treatment,~     stored at 0-2°C and reheated and browned prior to serving.~   "
81829|NCT02495857|"~     The study is a prospective, multi-center, randomized, three-arm, parallel group, clinical~     study to evaluate the superiority of 3 weekly intra-articular (IA) doses of 2 mL of~     Investigational hyaluronate as compared to placebo injected into the target knee for the~     treatment of pain in subjects with Osteoarthritis (OA).The safety and effectiveness of the~     investigational product will also be compared with Euflexxa.~   "
81830|NCT02495844|"~     This study is to assess the efficacy, safety, and tolerability of the investigational drug~     UCB0942in adult subjects with drug-resistant focal epilepsy across multiple centers in~     Europe.~   "
81831|NCT02495831|"~     To evaluate if a single dose of safinamide 200 mg has an effect on the pharmacokinetics of~     diclofenamic acid, concomitantly administered as a single 50 mg diclofenac sodium dose, with~     respect to 50 mg diclofenac sodium administered alone.~   "
81832|NCT02495818|"~     The purpose of this study is to evaluate the effect of suprascapular nerve block guided by~     ultrasound combined with home exercises compared with placebo. Pain intensity, function,~     pressure pain threshold and goniometry were designed to be assessed in all patients.~   "
81833|NCT02495805|"~     The purpose of the study is to compare continuous femoral nerve block with continuous~     proximal adductor canal block for postoperative pain control and rehabilitation.~   "
81834|NCT02495792|"~     The purposes of this study are 1) to assess foot strike patterns initially, at six months and~     at one year between two groups of runners attempting to transition to a non-rearfoot strike~     pattern (NRFS) with and without the use of biofeedback technology, and 2) to prospectively~     compare injury incidence rates at one year between NRFS and rearfoot strike (RFS) runners.~   "
81835|NCT02495779|"~     This study is designed to investigate the acceptability, perceived need and uptake of~     short-term episodic Pre-Exposure Prophylaxis (PrEP) for HIV prevention among men who have sex~     with men (MSM). The overall objective is to determine the feasibility of a clinic-based~     Epi-PrEP implementation pilot project for 50 MSM (25/each of the 2 study sites) who report~     occasional condomless sex and who anticipate a period of high-risk while away from home (e.g.~     vacation) during the study period.~   "
81836|NCT02495766|"~     This study evaluates the effect of cryopreserved autologous adult bone-marrow mesenchymal~     stromal cells (BM-MSC) in patients with active multiple sclerosis, compared to placebo.~      Patients will be allocated to one of the 2 treatment arms (BM-MSC or placebo)and at month 6,~     the treatment will be crossed to receive the other product. The objective is to assess the~     safety of a single infusion BM-MSC, and to explore its efficacy in these patients.~      Patients will be evaluated at month 12 and will be followed-up for a total of 3 years.~   "
81839|NCT02495727|"~     Muscle size declines at around 0.5-1% per year after 50 years of age, with muscle strength~     declining up to twice as fast as muscle size. This may eventually lead to loss of~     independence if tasks of daily living become too strenuous to be performed safely. Short~     periods of bed rest cause very rapid loss of muscle size and strength, and studies using~     healthy older participants have shown that age increases vulnerability to this muscle loss.~     However, it is unlikely that healthy individuals would be faced with periods of bed rest~     unless suffering a severe illness. In light of this, recent evidence has shown that even just~     reducing walking to less than 1,500 steps per day for two weeks caused 4% loss of leg muscle~     in over 65 year olds. This amount of activity is roughly the equivalent of being housebound,~     something that may become more common into older age, for example due to prolonged bad~     weather, or minor injury or illness.~      This study will investigate what causes such stark muscle loss during two weeks of reduced~     activity, and the impact on skeletal muscle function and size, as well as balance, body~     composition, and other indicators of general health such as how the body responds to food or~     exercise. Importantly, exercise strategies that could reduce muscle loss during a period of~     reduced activity will also be investigated.~      In brief, three groups of 10 older men (aged 65-80 years) will undertake two weeks of reduced~     physical activity by limiting their daily steps to <1,500/day. All groups will then undertake~     a re-training exercise programme to ensure that any losses in muscle strength or size are~     regained. One of the groups will be a control, whereby they will undertake the step-reduction~     intervention and re-training, but no protective exercise before or during the step-reduction~     intervention. This group will allow us to achieve our primary objective of determining the~     influence of two weeks of reduced physical activity on muscle strength and size in healthy~     older males. The two other groups will undertake either four weeks of strength exercise~     training before the step-reduction intervention, or daily home based exercise 'snacking'~     during the step-reduction intervention. The potential protective benefits of the exercise~     interventions in reducing the impact of two weeks of reduced activity on muscle strength and~     size, and any effect on how muscle is re-gained afterwards, will be compared to the 'control'~     group.~   "
81840|NCT02495714|"~     HOPP Learning will be implemented in elementary schools in the Horten municipality and will~     assess the effect of a combined pedagogical approach, active learning, on a large student~     population. Students are to increase their amount of physical activity with learning, during~     a school day by one hour.~   "
81841|NCT02495701|"~     Arthroscopic hip surgery is performed with traction on the leg to allow the surgeon to~     perform the surgical procedure. A retrospective study has described neuropraxia, ankle joint~     pain and a skin burn after surgery (1). Moreover, it has been described that surgeons~     performing the procedure have a learning curve related to the number of complications~     described postoperatively. At the investigators' institution, hip arthroscopies have been~     performed since 2010 and the 3 surgeons have 4-12 years of experience. During the past years,~     changes have been made to secure the best possible comfort for the patient during the~     arthroscopic procedure. Hence, there is a rationale for investigating complications after hip~     arthroscopy in a setting that is less affected by the surgeon's learning curve and with the~     patient comfort in focus.~   "
81842|NCT02495688|"~     The purpose of this study is to compare general and regional anesthesia with regard to~     postoperative pain in patients who undergo surgery in a day surgery setting due to a~     displaced distal radius fracture.~   "
81843|NCT02495675|"~     This study evaluates the work of breathing among healthy subjects under various conditions of~     treatment with high flow nasal cannulas. Ten subjects will be included. The design of this~     study is a cross over of five treatment periods with different flow settings.~   "
81844|NCT02495662|"~     This study will investigate if liposomal prednisolone is effective in promoting arteriovenous~     fistula (AVF) maturation when administered to human subjects after surgical creation of a~     radio-cephalic AVF.~   "
81845|NCT02495649|"~     The purpose of this study is to evaluate the added value of PET-CT with [18F]FDOPA tracer for~     Assessment of the Myocardial Sympathetic Denervation in patients with or suspected with~     Parkinson's disease.~      The investigators expect to see normal values of uptake ratio of [18F]FDOPA , in patients~     with no synuclein underline pathology or previously known cardiovascular disease (no history~     of high blood pressure or take medications that influence the sympathetic system- exclusion~     criteria). Low values of uptake ratio is presumed to be found in patients diagnosed with~     Parkinson's disease or other synuclein pathology.~      The expected normal ratio of Heart/liver uptake values will be determined from scans of~     patients refered to [18F]FDOPA scan and were found to have normal [18F]FDOPA scan of the~     basal ganglia and no cardiovascular diseases.~   "
81846|NCT02495636|"~     The primary purpose of this study is to look at effects, good or bad, of combining two~     investigational anti-cancer drugs called MPDL3280A and CDX-1401. CDX-1401 is given in~     combination with a third agent, poly-ICLC, which is another investigational drug that is~     believed to work together with CDX-1401. All investigational drugs, MPDL3280A and CDX-1401 in~     conjunction with poly-ICLC, have been evaluated separately in prior studies; however, this is~     the first study assessing the combination therapy.~   "
81847|NCT02495623|"~     A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multi-Dose Study of the~     Effect of Two Dosage Strengths of SYN-010 Compared with Placebo on Breath Methane Production~     in Breath Methane-Positive Subjects with Irritable Bowel Syndrome with Constipation (IBS-C)~   "
81848|NCT02495610|"~     INPH is a chronic, progressive disease characterised by enlarged ventricles in the absence of~     elevated intracranial pressure. Patients often present with the Hakim triad comprising gait~     disturbance, dementia and urinary incontinence. Treatment consists of ventriculoperitoneal~     (VP) shunting reducing the cerebrospinal fluid (CSF) volume in the central nervous system~     (CNS); a generally safe and well tolerated procedure nevertheless invasive in nature and~     associated with surgical risk. The currently used diagnostic algorithms to predict surgery~     outcome by testing patients before and after a diagnostic spinal tap temporarily reducing the~     CSF volume in the CNS are of wide variability and limited validity. Developing measures to~     accurately diagnose and select patients for intervention is thus of great importance. The~     objective of this study is to define and validate a diagnostic algorithm for the selection of~     patients with symptoms compatible with iNPH for shunt surgery.~   "
81849|NCT02495597|"~     The investigators here compare lung function parameters (RV, RV/TLC and FEF75) with the~     results of the Lung Clearance index (LCI) . Further this study evaluates bronchial~     inflammatory markers in 20 patients with bronchiolitis obliterans at the age of 6 to 28 years~     compared with an age- and sex-matched control group. The investigators will perform a~     pulmonary function test (body plethysmography with DLCO) and compare the results with the~     LCI. Further we will measure the fraction of exhaled nitric oxide (FeNO) and draw a blood~     sample to determine the level of systemic inflammation. Finally induced sputum is collected~     and a cell count is performed, and cells and supernatants are analyzed for inflammatory~     markers. This study will set baseline markers for future interventional studies.~   "
81906|NCT02494843|"~     The purpose of this study is to characterise, in detail, the cardiac structure, function and~     perfusion of those on haemodialysis and haemodiafiltration, comparing the two modalities to~     ascertain if haemodiafiltration provides relative myocardial protection compared to~     conventional haemodialysis.~   "
81850|NCT02495584|"~     Vitamin D insufficiency has become a global concern, with low vitamin D status associated~     with bone disorders, cardiovascular disease and certain cancers. The United Kingdom (UK) and~     Ireland are at particular risk of vitamin D deficiency owing to the northerly latitude,~     increased use of sunscreen, decreased sun exposure and a high level of cloud cover. A recent~     survey in the UK showed that more than 50% of UK adults have insufficient vitamin D status,~     with lower levels noted in the winter months. Variations in vitamin D status have been known~     to vary between summer and winter, owing to our northern latitude (52-55°N) the Ultraviolet~     (UV)-B intensity in Northern Ireland is inadequate to promote the dermal synthesis of vitamin~     D during the winter months, causing us to rely on dietary sources. The aim of this~     intervention is to investigate the main effects of vitamin D3-fortified milk and supplemental~     vitamin D3 on vitamin D status and functional health outcomes during the winter, and how this~     intervention will affect subsequent dermal synthesis of vitamin D from UV exposure.~     Participants will be recruited from the local community. Blood samples will be collected from~     each participant at two timepoints (September/October and March/April). Pre- and~     post-intervention blood pressure, grip strength, height, weight, waist and hip circumferences~     will be measured, in addition participants will undergo a dual energy x-ray absorptiometry~     (DXA) scan to assess body composition and bone mineral density. Information on general~     health, lifestyle, physical activity, dietary intake and typical behaviours in the sun will~     be collected. Following the dietary intervention, a subset of participants will be invited to~     participate in a follow-up study, examining UV exposure during the summer months, when they~     will wear a personal wrist dosimeter for 1 month, complete a sun dairy and provide 2~     additional blood samples.~   "
81851|NCT02495571|"~     This study aims to assess the presence and the intensity of voluntary and cough reflex in~     patients with amyotrophic lateral sclerosis (ALS), comparing the results with the healthy~     control group. The assessment of the cough is fundamental to verify the mechanism of airways~     protection which is particularly compromised in ALS patients.~      Objective parameters of voluntary and reflex cough would be measured by the spirometer. The~     reflex of cough would be elicited by a solution of citric acid through an ultrasonic~     nebulizer.~   "
81852|NCT02495558|"~     The cough assessment is fundamental in the weaning process as it gives information on the~     possibility to expel food and secretion out from the airways. The majority of persons~     suffering from severe acquired brain injury are not able to cough voluntary due to severe~     cognitive deficit. In the present study, it would be evaluated the intensity of the reflex~     cough (RC) and the results would be correlated with weaning outcome.~   "
81853|NCT02495545|"~     The purpose of this Phase IIB randomized controlled trial is to evaluate the safety and~     efficacy of CSFD and to provide a preliminary clinical efficacy evaluation of the combination~     of CSFD and elevation of mean arterial pressure (MAP) in patients with acute spinal cord~     injury (SCI). The objectives of the trial are to evaluate (i) efficacy of reducing~     intrathecal pressure (ITP) by CSFD in patients with acute SCI; (ii) preliminary efficacy of~     combination of CSFD and elevation of MAP compared to elevation of MAP alone in improving~     neurologic motor outcomes in patients with acute SCI; and, (iii) safety of intensive CSFD in~     acute SCI patients.~   "
81854|NCT02495532|"~     Regional lymph node metastasis is a major determinant of local recurrence and overall~     survival rates in patients with colorectal cancer. Because of the poor prognosis associated~     with the presence of lymph node metastasis, stage III colorectal cancer patients should~     receive adjuvant treatment with chemo and / or radiation therapy according to the site of~     tumor. Several authors have investigated the use of revealing solutions for lymph node~     clearance in colorectal cancer. Most studies comparing conventional histopathological~     specimen examination to any lymph node clearing technique showed that the use of revealing~     solutions increases the mean number of lymph nodes harvested, usually in a statistically~     significant manner. It is still controversial the impact of the use of revealing solutions~     for upstaging of lymph node status and consequently for the indication for adjuvant therapy.~     Therefore will be conducted a randomized clinical trial to compares the performance of GEWF~     and Carnoy solutions for the histopathological examination of patients with colorectal~     cancer. The aim of this study is to determine the lymph node revealing solution with the best~     performance (increase in the mean number of lymph node harvested and lymph node upstaging) in~     patients with colorectal cancer.~   "
81855|NCT02495519|"~     Aggressive fibromatosis (AF, also known as desmoid tumor) is a fibroproliferative neoplasm~     that typically arises in the abdomen but can develop at other anatomic sites, most commonly~     in the extremities. These tumors have a relatively high local failure rate after primary~     treatment using surgery and/or radiotherapy, and although rarely giving rise to distant~     metastases, can be multifocal and, therefore, not surgically resectable. Moreover, tumor may~     recur adjacent to the site of surgical resection, underscoring the limitations of surgery in~     the palliative setting. Therefore, effective medical therapies for AF are needed to maintain~     quality of life and prolong survival.The goal of the current study was to better define the~     activity of imatinib in the treatment of AF and to determine the molecular basis for~     response/nonresponse~   "
81856|NCT02495506|"~     This study will investigate the effects of Leukocyte reduced cold-stored platelet~     transfusions used in treatment of immediate postoperative blood loss in patients undergoing~     thoracic surgery in combination with extracorporal circulation. Today platelet concentrates~     are stored at 22 degrees C .~      This is a prospective, randomized, unblinded, non-inferiority two-arm study. Aimn of study is~     to compare platelet function in bleeding patients transfused with leukoreduced platelet~     concentrates stored cold (4 degrees C) and in room temperature (22 degrees C). Patients with~     expected time on extracorporal circulation more than 120 minutes and/or medical platelet~     inhibitors will be included.~      Platelet function will be assessed by use of Multiplate Aggregometry, Thromboelastography~     (TEG) and/or Thromboelastometry (ROTEM). In addition post operative bleeding, and adverse~     events will be recorded.~   "
81857|NCT02495493|"~     Currently, for further improved survival outcome, new cytotoxic compounds such as irinotecan~     and docetaxel have been combined with 5-FU/cisplatin. However, triplet regimen often burdened~     with higher toxicity and serious neutropenic infection. Therefore, future trials in~     neoadjuvant and adjuvant settings need to incorporate new molecular agents which improve~     efficacy, but less toxicity.~   "
81873|NCT02495285|"~     The aim of volume replacement is to compensate a reduction in the intravascular volume e.g.~     during surgery and to counteract hypovolemia in order to maintain hemodynamics and vital~     functions. So far, there is only few data on the safety and efficacy of the products under~     investigation in children.~      The primary aim of this non-interventional observational study (NIS) is to collect further~     data of gelatine solutions in a large pediatric population during routine clinical practice.~   "
81874|NCT02495272|"~     The investigators are planning to determine the effect of the timing of oxytocin~     administration on the amount of blood loss, necessity for additional medical or surgical~     interventions.~   "
81858|NCT02495480|"~     A novel disposable sheathed gastroscope system has been shown to be safe and more efficient~     in clinical practice during gastroscopy. This novel disposable sheathed endoscope system~     could effectively prevent cross-infection by simply taking off the contaminated sheath after~     examination of a patient and placing a new sheath on the endoscope. In this way,~     investigators can save the endoscopic reprocessing time and also decrease the need for~     endoscopic cleaning and disinfecting equipment.~      Participants may think that placing a new sheath on the endoscope can decrease the success~     rate of cecal intubation in patients undergoing screening colonoscopy. With a new sheath on~     the endoscope during scope insertion can probably increases distension of the colonic lumen~     and loop formation. The probable adhesion may increase the discomfort of investigators and~     participants. But a previous clinical study by investigators' team showed that the~     participants' feeling were no significant difference (Z = -1.783, P = 0.075) between sheathed~     and conventional groups. No significant differences were observed in optical clarity, or~     pathology detection rate. There were no complications, and no microbial contamination was~     detected. Based on this study, investigators hypothesize that compared with conventional~     group, placing a new sheath on the endoscope does not significantly reduce the success rate~     of cecal intubation in average patients.~      The aim of the study is to compare the outcome of colonoscopy placing a new sheath on the~     endoscope versus the conventional method in average participants. The primary outcome is~     cecal intubation success rate. The secondary outcomes include cecal intubation time, maximum~     pain score during colonoscopy, overall pain score after colonoscopy and adenoma detection~     rate.~   "
81859|NCT02495467|"~     This study is designed to evaluate the efficacy and safety of MED2005, a topically applied~     glyceryl trinitrate (GTN) gel administered to the penis of male subjects self-diagnosed with~     erectile dysfunction (ED) immediately before sexual intercourse.~   "
81860|NCT02495454|"~     GA101-miniCHOP regimen for the treatment of elderly unfit patients with diffuse large B-cell~     non-Hodgkin's lymphoma.~   "
81861|NCT02495441|"~     The aim of the study is to demonstrate substantial equivalence of IGFBP-1/AFP tests with the~     predicate device Amnisure® in detecting pre labor rupture of membranes. 4 test kits are~     compared against a common referent standard (gold standard), which is clinical assessment.~   "
81862|NCT02495428|"~     The aim of this study was to determine the effect of Kinesio taping on lactic acid in an~     running anaerobic test.~   "
81863|NCT02495415|"~     This study addresses the hypothesis that intermittent treatment with fenretinide intravenous~     emulsion will induce objective responses in patients with relapsed or refractory Peripheral~     T-cell Lymphoma (PTCL) who have failed at least one prior systemic therapy and will result in~     acceptable toxicities.~   "
81864|NCT02495402|"~     To test the effectiveness of a single 20-30 minute motivational interviewing-based brief~     intervention for substance use within HIV/AIDS settings.~   "
81865|NCT02495389|"~     This study is for women diagnosed with urgency incontinence or overactive bladder (OAB). Some~     patients continue to have symptoms even while taking medication for OAB. The purpose of this~     study is to see if women who respond to a medication called mirabegron have different bladder~     bacteria than women who do not respond.~   "
81866|NCT02495376|"~     We propose to examine the effects of mindfulness based stress reduction (MBSR) on outcomes of~     health related quality of life, disease symptoms, and biological correlates of stress in a~     sample of young adults with cancer. The proposed work will serve as an essential foundation~     for launching a program of clinical stress reduction research with this traditionally~     underserved population and has the potential to lead to the discovery of specific, modifiable~     psychosocial, behavioral, and biological mechanisms from which to address the problem of~     health disparities with this group.~   "
81867|NCT02495363|"~     Examining the analgesic effect of ultrasound guided Pectoral Blocks on analgesic opioid~     consumption after surgical removal of breast tissue.~      This study's uniqueness is in the quantification of the analgesic effect of regional~     anesthesia on its influence to reduce the use of opioid substances, and the variety of side~     effects associated with them, which has yet to been described in literature.~   "
81868|NCT02495350|"~     In this study the investigators would like to evaluate how prelabor analgesic plan and actual~     labor analgesia effects the labor satisfaction, breastfeeding success, and whether or not it~     reduces postpartum depression.~      Although postpartum depression has been researched and reviewed, there is little information~     on how satisfaction during labor affects postpartum outcomes. The relationship between~     epidural analgesia is also complex, and there has yet to be found a valid correlation between~     the two parameters.~      In addition although an attempt has been made to evaluate relationship between breastfeeding~     and epidural analgesia, results are unclear and further research is needed.~   "
81869|NCT02495337|"~     This proposed collection of primary tumor cells lines will benefit esophageal cancer research~     within the University Health Network. This collection of gastro-esophageal tumor samples will~     be used to grow primary tumor cell lines, which will provide researchers with ready samples~     of various gastro-esophageal cancers. This will help to address the issue of access to these~     cell lines due to the limited number of patients with gastro-esophageal tumors, and high~     rates of contamination.~      Samples will be collected during surgery or Esophagogastroduodenoscopy(EGD). The surgeon will~     resect a sample for the research coordinator and/or fellow who will collect the sample and~     take it back to the lab for processing. Samples collected will be in excess of standard~     samples that are sent for pathology. The surgeon will make sure that excess samples will not~     affect pathological diagnosis~   "
81870|NCT02495324|"~     The purpose of this study is to evaluate the efficacy and safety of Fimasartan compared to~     Valsartan and Olmesartan(reference group) in patients with mild to moderate essential~     hypertension. Patients have 2 weeks of placebo run-in and wash out period, 2 weeks of taking~     required dose and 4 weeks of taking double dose.~   "
81871|NCT02495311|"~     The aim of this study is to assess the relationship between adenomyosis/myoma and lower~     urinary tract symptoms, sexual function and gastrointestinal symptoms.~   "
81872|NCT02495298|"~     The trial aims to evaluate the effectiveness of Fascial Manipulation on pain reduction,~     functional recovery and nerve conduction of patients with Carpal Tunnel Syndrome (CTS).~     Visual Analogue Scale (VAS), Disabilities of the Arm, Shoulder and Hand scale (DASH), Boston~     Carpal Tunnel Syndrome Questionnaire (BCTQ) and Electroneuromyography were assessed.~      The study is blind for the patient and the raters.~   "
81876|NCT02495246|"~     This is a clinical trial in which healthy volunteers will be administered two experimental~     Ebola vaccines: ChAd3-EBO-Z and Ad26.ZEBOV. Four groups of volunteers will be vaccinated with~     both vaccines one after the other in a prime/boost regimen.~      All ChAd3-EBO-Z doses are 1x10^11 vp and all Ad26.ZEBOV doses are 5x10^10 vp.~      Group 1 will receive a ChAd3-EBO-Z priming vaccine and an Ad26.ZEBOV boosting vaccine 28 days~     later.~      Group 2 will receive an Ad26.ZEBOV priming vaccine and a ChAd3-EBO-Z boosting vaccine 28 days~     later.~      Group 3 will receive a ChAd3-EBO-Z priming vaccine and an Ad26.ZEBOV boosting vaccine 56 days~     later.~      Group 4 will receive an Ad26.ZEBOV priming vaccine and a ChAd3-EBO-Z boosting vaccine 56 days~     later.~      The study will assess the safety of the vaccinations, and the immune responses to~     vaccination. Immune responses are measured by tests on blood samples.~      The ChAd3-EBO-Z and Ad26.ZEBOV vaccines are called viral vectored vaccines. They are made~     from viruses which are modified so that they cannot multiply. The viruses have extra DNA in~     them so that after injection, the body makes Ebola proteins (but Ebola does not develop), so~     that the immune system builds a response to Ebola without having been infected by it.~      Healthy volunteers will be recruited in Oxford and London, England. The study will be~     co-funded by GSK Biologicals and Crucell Holland BV.~   "
81877|NCT02495233|"~     The purpose of the Phase 1b part of the study is to evaluate the safety and tolerability of~     ASP2215 in combination with erlotinib and determine the recommended phase 2 dose (RP2D) of~     ASP2215. The purpose of the Phase 2 part of the study is to evaluate the objective response~     rate (ORR) of the RP2D of ASP2215 in combination with erlotinib.~   "
81878|NCT02495220|"~     The purpose of the present study was to evaluate the efficacy and safety of subtenon block~     (SB)anesthesia with dexmedetomidine in combination with bupivacaine versus intravenous~     dexmedetomidine for postoperative analgesia and emesis control in infants undergoing cataract~     surgery.~   "
81879|NCT02495207|"~     Evaluation of the effect of conventional and piezo-surgery on the secretion of Heat Shock~     Protein (HSP70) and on the vial bone cells at the peripheral bone cut sides after the removal~     of impacted mandibular third molars on both sides of the jaw.~   "
81880|NCT02495194|"~     The objective of this study is to determine whether horticultural therapy would improve the~     psychological well-being of the older adults. 70 healthy elderly were randomized into the~     active horticultural therapy or the waitlist control group. Sessions will be conducted weekly~     for 12 weeks, and monthly for 3 months. Participants would be assessed at 3 time-points: at~     the start, at 3-months and at 6-months.~      It was hypothesized that as compared to the waitlist control group, participants in the~     active horticultural therapy will have (1) lower depression and anxiety symptomatology; (2)~     higher life satisfaction; (3) feel more socially connected; and (4) improved cognitive~     functioning.~   "
81881|NCT02495181|"~     The purpose of this study is to compare the efficacy and safety of intravitreal Aflibercept~     monotherapy with the efficacy and safety of combined treatment with Aflibercept plus standard~     photodynamic therapy (PDT) with Verteporfin in age-related macular degeneration (AMD)~     patients with polypoidal choroidal vasculopathy (PCV).~   "
81882|NCT02495168|"~     A randomized multiple-dose, placebo-controlled, parallel group design consisting of a 2-week~     run-in period followed by a 6-week treatment period of the placebo, Test product (Budesonide~     80 mcg / Formoterol fumarate dihydrate 4.5 mcg), or Reference product Symbicort® inhalation~     aerosol.~   "
81883|NCT02495155|"~     In order to determine the acceptability of a breast cancer-specific cognitive behavioral~     therapy intervention, as well as to obtain preliminary data to assess efficacy in managing~     symptoms, the investigators will ask 45 breast cancer survivors with moderate insomnia,~     fatigue, and/or pain to use the investigators' internet-based intervention for 8 weeks and to~     complete patient-reported outcomes assessments before and after the 8 week intervention.~   "
81884|NCT02495142|"~     Bariatric surgery is associated with long-term weight loss, as well as short-term~     improvements in obesity-related medical comorbidities. However, a significant proportion of~     patients fail to lose sufficient weight, or experience significant weight regain. Although no~     robust predictors of response have been identified, pilot data that will be presented and~     reviewed suggest that surgery has profound effects on eating behaviors and psychosocial~     functioning, and that these factors may affect postoperative weight control.~      The present investigation capitalizes on the Longitudinal Assessment of Bariatric Surgery~     (LABS) consortium to conduct an in-depth examination of the psychosocial aspects of surgery~     among a geographically, ethnically, and racially diverse sample of men and women undergoing~     bariatric surgery. This project unites experts in the areas of psychopathology, eating~     behaviors and quality of life to conduct a naturalistic study using state-of-the-art~     assessment tools; to document the relationships among psychosocial factors; and to examine~     psychosocial predictors of surgical outcomes.~   "
81885|NCT02495129|"~     This study consists of three consecutive parts. Part 1 in primary Sjögren's syndrome (pSS)~     patients (n=2-6) and Part 2 in healthy voluteers (n=3) are feasibility studies to assess if~     the selected [Zr-89]-rituximab PET/CT method is a valid method to assess B cells in salivary~     glands of pSS patients. In Part 1 and Part 2 no IMP will be applied to the subjects. In Part~     3, pSS patients (n=12) will receive the IMP, VAY736. Posted information will be focused on~     Part 3.~      The overarching purpose of this study is to test a new drug (VAY736) for the treatment of~     pSS. In pSS, the salivary glands (the glands that produce saliva) and other organs are~     affected by inflammation. A certain type of white blood cells called B cells prominently~     infiltrate the salivary glands in pSS, whereas they are not present in healthy salivary~     glands. Scientific evidence suggests that B cells may be involved in the disease process in~     pSS and that eliminating B cells may benefit patients with pSS. This study will test a new~     imaging method and a new treatment for pSS. Both the imaging method and the treatment are~     specific for B cells.~   "
81907|NCT02494830|"~     This study is designed for descriptive pharmacokinetic characterization of ketamine and~     norketamine in serum, urine and feces after oral single dose administration of a new~     developed prolonged release tablet formulation containing 10, 20, 40 and 80 mg ketamine under~     fasting conditions and for descriptive pharmacokinetic characterization of ketamine and~     norketamine in serum, urine and feces after intravenous single dose administration of 5 mg~     ketamine solution for infusion within 30 min~   "
98531|NCT02277535|"~     This is a quality improvement research project evaluating if a targeted feedback email to~     clinicians impacts their nutrition delivery in the ICU.~   "
81886|NCT02495103|"~     Background:~      - There are no established treatments for people with certain advanced kidney cancers. These~     tumors often don t respond well to currently available treatments. Researchers believe that~     two drugs that treat other diseases metformin and vandetanib could help people with advanced~     kidney cancer.~      Objective:~      - To test the combination of metformin and vandetanib in people with advanced kidney cancer.~     Phase I of the study will determine a safe dose for the drugs. Phase II will test this dose~     in people with certain kidney cancers.~      Eligibility:~        -  For Phase I, people 18 and over with advanced kidney cancer~        -  For Phase II, people 18 and over with advanced hereditary leiomyomatosis and renal cell~          cancer (HLRCC), succinate dehydrogenase renal cell carcinoma (SDH-RCC), or advanced~          papillary renal cell carcinoma not related to a hereditary syndrome~      Design:~        -  The study will last many months.~        -  Participants will be screened with medical history and physical exam.~        -  Participants will take the study drugs by mouth every day.~        -  Participants will measure and record their blood pressure every day.~        -  Participants will have many tests:~        -  Blood and urine tests~        -  MRI, CT, PET scan, and other imaging tests: they will lie in machines that take pictures~          of their body.~        -  ECG: soft electrodes will be stuck to the skin. A machine will record the heart s~          signals.~        -  Bone scan~        -  Some participants may have a gynecology evaluation or photos of skin tumors taken.~        -  Participants will have an optional tumor biopsy.~        -  After they stop taking the drugs, participants may have medical history, physical exam,~          and blood tests. They will be contacted once a year by phone to find out how they are~          doing.~   "
81887|NCT02495090|"~     Hypospadias is the second most common malformation of the male genitalia and consists in a~     congenital hypoplasia of its ventral face. Hypospadias results from abnormal development of~     the penis that leaves the urethral meatus proximal to its normal glanular position. Meatus~     position may be located anywhere along the penile shaft, but more severe forms of hypospadias~     may have a urethral meatus located at the scrotum or perineum. Glandular and penile anterior~     represents approximately 70% of all the diagnosed cases.~      The frequency of family reached depend on the severity of hypospadias. The number of children~     which have hypospadias mutation discovered by classical technique is low. Families are often~     the cause of the discovery of new genes involved in sexual differentiation because they allow~     comparison of genomes of related persons, and detect more easily mutations.~   "
81888|NCT02495077|"~     During transplant surgery, there is a period of time when a donated kidney is removed from a~     donor's body and stored until the time of the transplant surgery. The storage procedure~     results in buildup of various proteins within the kidney that can injure the donated kidney~     after it is transplanted. One of these proteins is tumor necrosis factor-alpha (TNF-alpha).~      The purpose of this study is to evaluate whether taking infliximab, which blocks TNF-alpha,~     just prior to transplant surgery along with usual transplant medicines will protect the~     donated kidney from damage caused by TNF-alpha and help keep the transplanted kidney healthy~     for a longer period of time.~   "
81889|NCT02495064|"~     Radiation dermatitis is an acute effect of radiation therapy,Especially in the neck skin of~     head and neck squamous cell carcinomas' patients.The investigators wanted to confirm the~     benefit of mometasone furoate (MF) in preventing acute radiation reactions, as shown in a~     previous study.~   "
81890|NCT02495051|"~     The frequency of Barrett's esophagus (BE) has increased in adults in the last decades, but BE~     is rare in children. Esophageal atresia (EA), the most common congenital anomaly affecting~     the esophagus, predisposes the patient to severe and prolonged gastroesophageal reflux~     disease. Because gastroesophageal reflux disease plays a major role in the development of BE~     by causing repeated mucosal damage, development of BE is a concern even in children and young~     adults in this specific population. The aim of this study is to assess the prevalence of BE~     (gastric and/or intestinal metaplasia) in a population of adolescents/young adults who had~     been treated for EA in early infancy. All eligible patients received upper gastrointestinal~     endoscopy under general anesthesia with standardized esophageal staged biopsies. Histological~     suspicion of metaplasia was confirmed centrally.~   "
81891|NCT02495038|"~     BACKGROUND: The combinations of rocuronium and cisatracurium have a synergic effect. The~     investigators studied whether the prediction is possible to have a sufficient effect of~     reducing the dose when combining the two neuromuscular blocking agents through monitoring~     neuromuscular relaxation during surgery.~      METHODS: Each group were intubating dose group (Group I, n=27) combined Effective Dose (ED)95~     rocuronium and ED95 cisatracurium, small amount reducing group (Group S, n=27) reduced 10% of~     each ED95 and large amount reducing group (Group L, n=27) reduced 20% of each ED95. Before~     patients arrived in the operating room, rocuronium and cisatracurium were prepared by a nurse~     who was not involved in this study. Each study drug was administrated to the patient and~     timer was started with TOF-Watch® monitoring. Train-of-four (TOF) of the ulnar nerve was used~     as setting of 2 Hz per 12 sec. The investigators checked time to TOF ratio=0 (Onset), time to~     1st TOF ratio>25% (Duration 25%) and TOF 25-75% (recovery index) under total i.v. anesthesia~     (TIVA). One way ANOVA was used for statistical analysis (α=0.05, β=0.2).~   "
81892|NCT02495025|"~     The purpose of this research study is to test the effectiveness of telephone-based early~     childhood developmental screening and care coordination, compared to usual care in a primary~     care pediatrics clinic. Investigators randomized 152 participants to one of two study arms,~     with the intervention families receiving developmental screening over the phone, and control~     families receiving usual care with their pediatricians.~   "
81893|NCT02495012|"~     A Phase IIb clinical trial to investigate the safety and efficacy of antiplatelet~     thrombolysin injection for patients with ST Segment Elevation Myocardial Infarction (STEMI)~     before receiving PCI therapy, in order to provide evidence for Phase III design.~   "
81894|NCT02494999|"~     In order to evaluate immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine~     produced by Beijing Minhai Biotechnology Co., Ltd., a randomized, double-blind,~     parallel-controlled phase III clinical trial is planned to conduct in healthy infants aged 2~     months in China.~   "
81895|NCT02494986|"~     The purpose of this study is to provide continued access to rilpivirine (RPV) for~     participants who were treated with RPV in a clinical development pediatric study with~     rilpivirine and who, at the time of roll-over, experience and are expected to continue~     experiencing clinical benefit from RPV treatment.~   "
81896|NCT02494973|"~     Currently, no adjuvant study with hepatic arterial infusion in the adjuvant setting is~     opened. Recently, the results of a phase II study (NCT00268463, NSABP-C-09) assessing the~     potential benefit of systemic oxaliplatin and capecitabine alternating with HAI of FUDR,~     after resection of CRLM have been reported.~      The primary end point was 2-year survival. Fifty-five of 76 eligible patients were able to~     initiate protocol-directed therapy and completed median of six cycles (range, one to six).~     Three postoperative or treatment-related deaths were reported. Overall, 88% of evaluable~     patients were alive at 2 years. With a median followup of 4.8 years, a total of 30 patients~     have had disease recurrence, 11 involving the liver. Median disease-free survival was 32.7~     months. In conclusion alternating HAI of FUDR and systemic capecitabine and oxaliplatin met~     the prespecified end point of higher than 85% survival at 2 years and were clinically~     tolerable.~   "
81897|NCT02494960|"~     Traditional smoking cessation clinics and telephone quitlines are expensive and 'passive' as~     they require motivated smokers to visit the clinic or make a phone call to seek help.~     However, in most middle-resource countries, smoking cessation clinics are not well~     publicized. Most health care professionals (HCP) are not active in performing smoking~     cessation counselling to their patients. They are not aware of the available smoking~     cessation services or the benefits of such services and hence do not refer smokers to smoking~     cessation services. On the other hand, physicians play a critical role in reducing tobacco~     use by advising smoking patients to quit (Richmond, 1999). Physician's advice to quit smoking~     not only motivates smokers to quit but also increases their quitting confidence (Fiore et~     al., 2000; Ossip-Klein et al., 2000).~      Brief smoking cessation interventions have been shown to be effective with strong evidence~     from randomized controlled trials (RCTs), however, it is no evidence to show that longer~     interventions are more effective than shorter interventions. If carried out in routine~     clinical practice by all physicians and other HCP, brief interventions can potentially~     benefit a great number of smokers and increase smoking cessation rate. Therefore, we propose~     to examine the effect of a brief smoking cessation counselling intervention (10-20 seconds~     AWARD model) among patients using a randomized controlled trail (RCT) design in Guangdong~     province, China~      This project aims to evaluate the effect of physicians' brief smoking cessation intervention~     (AWARD model) in real busy clinic settings using a randomized controlled trial (RCT) design.~   "
81898|NCT02494947|"~     The primary purpose of this study is to investigate if systematic, high intensity,~     interval-based aerobic exercise training results in regression of lipid content of~     atherosclerotic coronary artery plaques, and in reduction of plaque burden in patients with~     stable coronary heart disease. Composition and morphologic characteristics of plaques will be~     studied by intra-coronary near-infrared spectroscopy (NIRS) and intravascular ultrasound~     (IVUS) in patients undergoing percutaneous coronary intervention.~   "
81899|NCT02494934|"~     The purpose of the study was to compare the effectiveness of cognitive behavioural therapy~     (CBT) and physical therapy (PT) on pain and psychosexual outcomes in women with provoked~     vestibulodynia (PVD).~   "
81900|NCT02494921|"~     This is a Phase Ib/II open label clinical trial in patients with metastatic castration~     resistant prostate cancer. The objective of the phase Ib portion of the study is to establish~     the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of docetaxel (75 mg/m2 IV~     q21 days) and prednisone (5mg orally BID) in combination with ribociclib in escalating oral~     daily doses in patients with metastatic CRPC with prior resistance to abiraterone and/or~     enzalutamide who have not undergone prior chemotherapy for metastatic disease. Up to three~     cohorts will be enrolled to determine the MTD and DLT profile of this combination during~     Phase 1b. Dose escalation will follow the standard 3+3 design. The dosing schedule is being~     chosen to allow patients to be exposed to the most efficacious dosing schedule of docetaxel~     (75 mg/m2 every 3 weeks). If there is excess toxicity observed with the treatment combination~     at the first dose level (dose level I), an alternative dosing schema may be pursued with~     weekly docetaxel treatment (35 mg/m2 weekly), which has demonstrated activity in mCRPC and~     decreased risk of cytopenias compared with every 3 week dosing schedule.~      The Phase II portion (N = 29) of the study is a single arm, two stage, open-label study of~     ribociclib (dosed at the RP2D) in combination with docetaxel and prednisone to determine the~     efficacy and further define the safety of the treatment combination. Patients will be treated~     with the combination of ribociclib plus docetaxel + prednisone for up to 9 cycles. If there~     is no evidence of radiographic or clinical disease progression after 9 cycles of protocol~     therapy, patients may continue on single agent maintenance ribociclib until the time of~     disease progression. Patients will have the option of starting maintenance ribociclib after 6~     cycles of docetaxel if stable disease or better on re-staging scans. The dose of ribociclib~     used during maintenance will be the same dose as that immediately preceding cessation of~     docetaxel treatment.~   "
81901|NCT02494908|"~     As seen in previous studies Diffusion Tensor Imaging (DTI) MRI is able to detect very subtle~     changes in brain tissue even after a very short timescale of hours resulting from performing~     a cognitive task and learning, We wish to explore and compare those changes to patients with~     idiopathic PD (IPD) and see if there are changes in the learning process and can we detect~     them using widely available noninvasive techniques such as MRI.~   "
81902|NCT02494895|"~     To compare the clinical outcomes of dual antiplatelet therapy with aspirin and ticagrelor vs.~     ticagrelor monotherapy at 3 months after PCI in patients with acute coronary syndrome.~   "
81903|NCT02494882|"~     The purpose of this study is to test the safety of a new combination of three oral drugs in~     Ph+ ALL. These drugs are dexamethasone, dasatinib, and ruxolitinib. All three drugs have been~     studied before in humans.~      This is a phase I study in which ruxolitinib dose will start low for the first patient~     together with dexamethasone plus dasatinib. If this dose does not cause a bad side effect,~     the ruxolitinib dose will slowly be made higher as new patients take part in the study. This~     will help the investigators find the right dose of ruxolitinib to give together with~     dexamethasone and dasatinib that will be used in future studies~   "
81904|NCT02494869|"~     This study is being done to look at the effect that different amounts of progressive exercise~     training has on risk factors associated with developing breast cancer. These risk factors~     include exercise capacity, body weight, and body composition, as well as the expression of~     certain genes and levels of inflammatory factors in your breast tissue.~   "
81905|NCT02494856|"~     The present clinical trial randomized compared the clinical efficacy of the naproxen~     associated or not with esomeprazol, for the removal of lower third molars. Onset, duration of~     postoperative analgesia, duration of anesthetic action on soft tissues, intraoperative~     bleeding, hemodynamic parameters, postoperative mouth opening and wound healing at the 7th~     postoperative day were evaluated. For this purpose, 50 healthy volunteers underwent removal~     of symmetrically positioned lower third molars, in two separate appointments (one to two~     months apart), under local anesthesia with either articaine 4% (1:200,000 adrenaline) in a~     doubleblind, randomized and crossed manner.~   "
81932|NCT02494505|"~     The main objective is to study if the mycophenolate could decrease the proportion of patients~     who relapse during the IVIG tapering period and after the IVIG withdrawal.~   "
81908|NCT02494817|"~     Though technology is integrated into the lives of our target population, use of any~     particular technology will depend on the content delivered, aesthetic appeal, and overall~     design. Based on the completion and analysis of data from Phase 1, the investigators were~     able to obtain feedback on HIV-negative male couples' attitudes toward the original content~     in the prevention toolkit modules. The research team, along with the web-developers, used~     this feedback to specifically tailor the content of the modules to fit the unique needs of~     the intervention's target population: at risk HIV-negative male couples. For Phase 2, the~     investigators conducted focus groups at each site to help identify strengths and potential~     areas for improvement of the prevention toolkit, which will be incorporated before piloting~     it in the intervention for Phase 3 of this project. After assessing the acceptability of the~     prevention toolkit, including the content of modules, aesthetic appeal, and overall design~     with HIV-negative male couples target population, the research team will pilot test whether~     the RCT with the prevention toolkit will help reduce HIV risk through formation and adherence~     to a sexual agreement, reduction in occurrences of condomless anal sex with casual sex~     partners, and increase testing behaviors among at-risk HIV-negative male couples. The~     interactive website, herein referred to as the HIV prevention toolkit will contain unique~     modules about sexual agreements and effective HIV prevention strategies.~   "
81909|NCT02494804|"~     The purpose of this study is to determine whether combining of Temozolomide and~     cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with~     Malignant Gliomas. The effectiveness and safety of CIK cells for the treatment of Malignant~     Glioma is also evaluated.~   "
81910|NCT02494791|"~     This study will maximize identification of women with Lynch Syndrome using an enhanced~     screening strategy to identify those at risk. These women will be referred to genetic~     counselling for testing and those found to have Lynch Syndrome will be asked to invite first~     degree relatives to participate and undergo genetic testing for Lynch Syndrome. Screening~     guidelines and risk reducing surgery options for participants found to have Lynch Syndrome~     will be reinforced by the study and adherence to these guidelines will be assessed annually~     for ten years following Lynch Syndrome diagnosis to assess the impact and cost-effectiveness~     of this enhanced screening approach.~   "
81911|NCT02494778|"~     The purpose of the study is to collect and assess long term data on the safety, tolerability,~     and efficacy of pridopidine in patients with Huntington's disease (HD).~   "
81912|NCT02494765|"~     At King Khalid University hospital approximately 1200-1500 MRI are done yearly on pediatric~     and neonatal patients. The investigating hospital is one of the pioneers in providing this~     service in the Kingdom (which was established about 10 years ago) to the patients of this age~     group. Only a small percentage of pediatric patients with age above 8 years accept the~     procedure to be done without anesthesia; and majority of MRI procedures are done under~     general anesthesia. The airway management of these patients is commonly accomplished with~     laryngeal mask airways (LMA).~      LMA are in practice of anesthesia since early 1980s. Pediatric and neonatal patients~     (including ex-premature) have also been benefited by the use of LMA. There are many~     advantages of LMA over endotracheal tube (ETT) in pediatric patients like ease of insertion,~     securing airway rapidly, avoidance of muscle relaxants, reduced incidence of sore throat,~     post-operative hoarseness and coughing at the time of extubation, greater hemodynamic and~     intra ocular pressure (IOP) stability.~      There are different types of pediatric LMAs available e.g. I-gel, ProSeal, LMA supreme, LMA~     classic, LMA unique, LarySeal and Ambu. These devices differ morphologically from each other~     (silicone, polyvinyl chloride or soft gel). Out of all this variety of LMAs only few are MRI~     compatible (do not produce any artifact in the MRI image), for example Ambu LMA and I-gel LMA~     and in King Khalid University Hospital (the investigating hospital) these two types are being~     used.~      On search of literature the investigators found only one study in adults in which such~     comparison has been made and there was no study comparing different LMAs on the basis of~     their spatial effects on anatomical structures of the neck and airway in pediatric patients~     with age 12 years or below.~      In this prospective randomized study, the investigators will compare the spatial relationship~     of I-gel Trademark (TM) and Ambu® AuraOnce (AO)TM on pediatric airway in pediatric patients~     undergoing 3-D MRI under general anesthesia (GA).~   "
81913|NCT02494752|"~     Contour deformity of face causes both functional as well as aesthetic problems for the~     patient. Fat being an autologous tissue source is considered as an ideal soft-tissue filler~     because it is abundant, readily available, inexpensive, host compatible, and can be harvested~     easily and repeatedly. However absorption of grafted fat is a major problem resulting in lack~     of consistency of final clinical outcome. Adipose tissue derived mesenchymal stem cells have~     the potential to enhance the viability of the grafted fat and the reliability of the final~     outcome of surgery. In the current study potential of mesenchymal stem cells will be studied~     by comparing two groups of patients requiring fat grafting for contour deformities of face.~     Control group will have fat graft with out enrichment with stem cells whereas experimental~     group will have their fat graft enriched with mesenchymal stem cells. Comparison will be made~     regarding viability of grafted fat in two groups.~   "
81914|NCT02494739|"~     The purpose of this study is to investigate the possible antioxidant and anti-inflammatory~     effects of yogurt enriched with polyphenols after 2-week consumption by healthy individuals.~   "
81915|NCT02494726|"~     The overall purpose of this study is to evaluate how effective Thromboelastography (TEG) is~     on identifying ischemic and hemorrhagic stroke patients at increased risk for bleeding after~     receiving tissue plasminogen activator (tPA), as well as on differentiating between patients~     in whom optimal thrombolysis has been achieved, and those whom it has not.~   "
81916|NCT02494713|"~     This is a study for men who have locally-advanced prostate cancer and are eligible to undergo~     prostatectomy. Standard treatment is prostatectomy alone, but there is a chance that cancer~     may spread to other organs in the future, even after the prostate is removed. If this were to~     occur, standard treatment would be androgen deprivation therapy (ADT; hormone therapy that~     blocks testosterone) plus chemotherapy. Clinical trials suggest that neoadjuvant treatment~     (treatment given before primary therapy) may prevent a recurrence. The purpose of this~     research study is to assess the safety and benefit of ADT plus chemotherapy given before~     prostate removal.~   "
81917|NCT02494700|"~     The goal of this clinical research study is to learn about the effectiveness of low dose~     radiation therapy in patients with low grade B cell lymphoma or mantle cell lymphoma~     involving the eye.~      This is an investigational study. It is investigational to treat B cell lymphoma or mantle~     cell lymphoma involving the eye with lower doses of radiation. Radiation therapy given in~     this study is performed using FDA-approved and commercially available methods.~      Up to 50 participants will be enrolled on this study. All will take part at MD Anderson.~   "
83878|NCT02469090|"~     A 12-week, prospective, multi-center, randomized, double-blind, placebo controlled, Phase 3~     study in L-Dopa responsive PD patients with motor fluctuations (OFF episodes), designed to~     determine the efficacy, safety and tolerability of APL-130277.~   "
81918|NCT02494687|"~     Gastroparesis is a digestive disorder in which motility of the stomach is either slowed or~     absent. The gastroparesis prevents normal digestion from occurring. The purpose of this study~     is to provide oral Domperidone offered under the U.S. Food and Drug Administration (FDA)~     expanded access program, to patients that, based on the treating doctor's assessment, could~     benefit from , a prokinetic effect for the relief of refractory gastroesophageal reflux~     disease with upper gastrointestinal (GI) symptoms, gastroparesis, and chronic constipation.~   "
81919|NCT02494674|"~     This is a 1-month study that will examine the use of podcasting and a wearable wrist-worn~     device to track calorie intake and promote weight loss. A podcast is a digital audio file~     that can be listened to on portable media players, like iPods, and personal computers. This~     study will run from July 14, 2015 to August 11, 2015. In this study, you will receive weight~     loss information delivered via twice weekly podcasts. You will also track each meal you eat~     by wearing a provided watch-like device.~   "
81920|NCT02494661|"~     The purpose of this study is to access the acceptability and potential utility of nutritional~     intervention videos in 1) changing knowledge and attitudes about healthy eating, 2) improving~     healthy food shopping practices, and 3) enhancing skills for stress reduction during food~     shopping among low-income Latina mothers.~   "
81921|NCT02494648|"~     Obstructive sleep apnea (OSA) syndrome affects up to 5% of the general population. The~     prevalence is multiplied by 13 in coronary artery disease (CAD) patients. Many studies have~     shown that OSA syndrome was the main risk factor for cardiovascular morbidity and mortality~     (RR = 9.1 [95%, 2.6 to 31.2]).~      If the value of treatment with Continuous Positive Airway Pressure (CPAP) in symptomatic CAD~     patients (daytime sleepiness and/or 2 clinical symptoms with Apnea Hypopnea Index (AHI) ≥ 20)~     appears to be established, treatment with CPAP in asymptomatic CAD patients (with AHI> 30)~     may be too demanding. Alternative treatments are rare and results are highly variable.~     Therefore, it would be interesting to suggest other treatment modalities with moderate~     coronary and/or minimally symptomatic OSA syndrome.~   "
81922|NCT02494635|"~     This research trial studies two types of tests, an ultrasound test and a biomarker test, to~     see how well they predict how aggressive (invasive) bladder cancer is in samples from~     patients with bladder cancer. The aggressiveness of a tumor means how likely it is to invade~     the body and spread. The ultrasound test uses a fluorescent dye and stimulates cells under a~     microscope to see how they respond. This may allow doctors to predict how likely the cancer~     cells are to spread in the body. The biomarker test uses laboratory testing of samples from~     patients to study genes and other molecules that may predict the cancer invasiveness.~     Comparing two different ways of predicting cancer aggressiveness may help doctors identify~     how well they work, and may eventually allow doctors to predict aggressiveness without~     needing to take a biopsy.~   "
81923|NCT02494622|"~     Schwannomas are benign tumors that can reach giant sizes. The diagnosis and treatment of~     these cases differ from those of small schwannomas. The aim of this study was to review the~     diagnoses and surgical approach characteristics of the giant spinal schwannomas (GSS) of~     patients who underwent surgery.~   "
81924|NCT02494609|"~     A Two-way Study to Evaluate the Potential Pharmacokinetic Interactions Between Sotagliflozin~     (LX4211) and an Oral Contraceptive Containing Norgestimate and Ethinyl Estradiol, in Healthy~     Premenopausal Women.~   "
81925|NCT02494596|"~     This study will evaluate the safety, tolerability, and pharmacokinetics of the combination of~     rhuMab 2C4(Perjeta) and capecitabine (Xeloda) in participants with advanced solid tumors that~     have progressed during or after standard therapy, or for which no standard therapy is~     available. Participants will be enrolled and evaluated for dose-limiting toxicities (DLTs) in~     escalating-dose cohorts in order to determine the maximum tolerated dose (MTD).~   "
81926|NCT02494583|"~     This is a study of pembrolizumab (MK-3475) as first-line treatment for participants with~     advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. Participants will be~     randomly assigned to one of the three treatment arms of the study: pembrolizumab as~     monotherapy, or pembrolizumab + cisplatin + 5-fluorouracil (5-FU) or capecitabine, or placebo~     + cisplatin + 5-FU or capecitabine. The primary study hypotheses are that pembrolizumab in~     combination with chemotherapy is superior to chemotherapy alone in terms of Progression-free~     Survival (PFS) and Overall Survival (OS) in participants with programmed death-ligand 1~     (PD-L1) Combined Positive Score (CPS) ≥1 and that pembrolizumab combination with chemotherapy~     is superior to chemotherapy alone in terms of OS in participants with PD-L1 CPS ≥10. Primary~     study hypotheses also are that pembrolizumab monotherapy non-inferior to chemotherapy alone~     in terms of OS in participants PD-L1 CPS ≥1 and is superior to chemotherapy alone in terms of~     OS in participants with PD-L1 CPS ≥1 and in participants with PD-L1 CPS ≥10.~   "
81927|NCT02494570|"~     A phase 2 multi-center investigation of efficacy of ABI-009 (nab-rapamycin) in patients with~     advanced malignant perivascular epithelioid cell tumor (PEComa)~   "
81928|NCT02494557|"~     Diabetic type 2 patients (DB2) has a higher prevalence of coronary artery disease (CAD) than~     non-diabetic persons. Presence of CAD results in murmurs arising from the filling of the~     arteries and can be detected by the CADScor System and can together with biological patient~     profile indicate the risk of presence of CAD in the patient. In the pilot study 100~     asymptomatic DB2-patients examined with CADScor System and biomarkers will be compared with~     computed tomography (CT) cardiography and single-photon emission computed tomography (SPECT)~     for assessing if combination of patient profile (gender, age etc) combined with above~     measures may give rise to new improved risk scoring method for he DB2-patient.~   "
81929|NCT02494544|"~     Patients will be consecutively enrolled by implant. Implant groups will be those who have~     undergone surgery with either a ConforMIS iTotal® CR TKA or an Off-the- Shelf (OTS) system.~      The patient will conduct functional testing and answer questionnaires.~      The results will compare the ConforMIS iTotal with an Off the Shelf Knee replacement.~   "
81930|NCT02494531|"~     The goal of this study is to improve the diagnosis of Alzheimer's disease (AD) at two~     different stages (MCI and dementia) in illiterate subjects, using FDG- fluorodeoxyglucose -~     and florbetapir F 18 -PET imaging. This study will compare amyloid load and cerebral~     metabolism dysfunction in literate versus illiterate MCI and AD patients.~   "
81931|NCT02494518|"~     The purpose of the study is to determine if performing different types of aerobic exercise~     (cycling) before upper extremity exercises will help to improve outcomes after stroke.~   "
81933|NCT02494492|"~     Uveitis is a leading cause of blindness in the children and young adult's populations. One~     third of etiology are idiopathic. The reference treatments are corticosteroids and~     immunosuppressive agents. They have significant side effects, and patient's compliance is~     often poor. In addition, some uveitis are more resistant. Also, in these situations of~     deadlock therapeutic, investigators propose a cell therapy by administering regulatory T~     cells (Tregs) in the vitreous of patients.~   "
81934|NCT02494479|"~     This study is designed to evaluate the efficacy and safety of Prurisol using three different~     oral daily dose regimens administered to subjects with active mild to moderate chronic plaque~     psoriasis.~   "
81935|NCT02494466|"~     Supraglottic airway equipment used during anaesthesia application can lead to airway~     reactivity or even larynx spasm in sensitive children.~      Montelukast Sodium, used in asthma treatment, is a cysteinyl leukotriene Type 1 antagonist~     which reduces leukotriene C4, leukotriene D4 and leukotriene E4 synthesis. The use of~     Montelukast Sodium in airway reactivity is known to reduce the need for bronchodilator and~     corticosteroids.~   "
81936|NCT02494453|"~     Patients with breast cancer receive low doses to smaller volumes of the heart, but they also~     have an excellent long-term survival, so it is crucial to study the effects of low dose~     radiotherapy. Indeed, a recent study suggests that these effects can be seen within the first~     5 years after treatment, and that there is no dose threshold. The investigators wish to~     develop imaging and blood biomarkers of cardiac exposure, as a first step to identifying~     patients at increased risk for cardiac effects. These patients can then be targeted for close~     monitoring and early intervention, potentially with statins or ACE inhibitors. Additionally,~     by characterizing a time-course and radiation dose-volume relationship, potentially real-time~     modifications can be made to radiotherapy (RT) field design for patients sensitive to RT~     effects. Finally, this information can be incorporated into better designs of treatment plans~     for future patients.~   "
81937|NCT02494440|"~     The purpose of the study to evaluate Five-Dimensional Ultrasound in automated measurement of~     the fetal femur length at third trimester of pregnancy.~   "
81938|NCT02494427|"~     Dental restorations (crowns, inlays or onlays) can be made conventionally or by CAD/CAM. The~     current literature is weak and does not separate the medical results of these two techniques.~     However, the efficiencies enabled by CAD/CAM could, for the price of an initial investment,~     improve service to the patient by reducing the time required for these restorations, and~     possibly lower care costs.~      The aim of the study is to compare immediate medical results and short-term prosthetic~     restorations made conventionally or by CAD/CAM in randomized patients, and evaluate economic~     impacts and organizational aspects.~   "
81939|NCT02494414|"~     Early prognosis of cardiac arrest - nearly 40000 new cases per year in France - has been~     extensively studied, highlighting a poor outcome (less than 8% at hospital discharge).~     However, little is known on mid and long-term prognostic factors and how these patients do~     survive from the event.~      Using a regional cohort, the aim of the study is to describe long-term survival rate of~     cardiac arrest survivors, and to assess the influence of treatment strategies on survival and~     functional outcome.~   "
81940|NCT02494401|"~     This Study is a collaborative project with partners (people with scleroderma and~     stakeholders) designed to refine an internet program for patients with scleroderma and to~     compare the internet program to an authoritative educational book (Taking Charge of Systemic~     Sclerosis [TOSS]). During a 16-week comparative effectiveness 16-week randomized controlled~     trial, the investigators will recruit up to 250 patients who will be randomized to either~     TOSS or authoritative book for patients, The Scleroderma Book: A Guide for Patients and~     Families.~   "
81941|NCT02494388|"~     The study is based on a multi-center approach of needle based confocal laser endomicroscopy~     (nCLE) combined with endoscopic ultrasound (EUS) and EUS-guided fine needle aspiration (FNA)~     to evaluate pancreatic cystic lesions (PCL), in order to obtain a correct histopathological~     diagnosis.After detection of PCL, certain morphological EUS features allow the discrimination~     of specific cyst types. Additionally, EUS-FNA is recommended as the first-line procedure~     whenever pathological diagnosis is required; however the procedure has its drawbacks, mainly~     represented by the relatively low negative predictive value in diagnosing pancreatic cancer.~     In this case a more precisely diagnostic tool is required; the potential role of CLE has been~     explored in gastrointestinal (GI) pathology showing good accuracy for predicting the final~     histopathological diagnosis based on immediate evaluation of tissue and vascular patterns.~     Although the clinical impact of nCLE for the decision making algorithms in cystic pancreatic~     neoplasm has not yet been described, the hypothesis is that EUS-nCLE could allow targeted~     tissue sampling of cystic pancreatic neoplasms resulting in more accurate diagnosis. The aim~     of the study is to describe the clinical impact of nCLE for the clinical decision management~     algorithm based on EUS, EUS-FNA and/or EUS-CLE imaging criteria for cystic pancreatic~     neoplasms, while evaluating also the feasibility and safety of nCLE examination.~   "
81942|NCT02494375|"~     The primary goal of the study is to determine whether insufficient sleep is associated with~     poor glycemic control in type 1 diabetic children. Secondary goals aim to determine whether~     salivary amylase could be an easily accessible and non-invasive biomarker of sleep loss and~     somnolence, and whether insufficient sleep is linked to body composition. Sleep~     characteristics, glycemic control, salivary amylase and body composition will be assessed 3~     times, at 3-4 months intervals, in 82 type 1 diabetic children.~   "
81943|NCT02494362|"~     The purpose of the study is to determine whether a novel computer gaming hand exercise~     regimen would improve hand and arm function and be feasible in people with hemiplegia after~     Stroke affecting the hand.~   "
81944|NCT02494349|"~     The purpose of this study is to investigate and compare the pharmacokinetic characteristics~     and safety/tolerability between JLP-1207(Solifenacin/Tamsulosin 5mg/0.2mg)and~     co-administration of Solifenacin and Tamsulosin between Solifenacin and Tamsulosin in healthy~     male volunteers.~   "
81989|NCT02493764|"~     This study aims to compare treatment with imipenem/relebactam/cilastatin (IMI/REL) as a~     fixed-dose combination (FDC) with piperacillin/tazobactam (PIP/TAZ) FDC in participants with~     hospital-acquired and ventilator-associated bacterial pneumonia. The primary hypothesis is~     that IMI/REL is non-inferior to PIP/TAZ in the incidence rate of all-cause mortality.~   "
81945|NCT02494336|"~     This is a prospective, double-blinded, randomized controlled study comparing the efficacy of~     trans-incisional rectus sheath block to laparoscopic guided rectus sheath block for pediatric~     single-incision laparoscopic cholecystectomy (SILC). umbilical hernia repair in children.~      Patients aged 10-21 years old undergoing SILC for cholelithiasis, cholecystitis, or biliary~     dyskinesia will be screened for study inclusion. Eligible patients and their~     parents/guardians will be approached and, if agreeable, consented for the study~     pre-operatively. Patients will be randomized to receive either trans-incisional rectus sheath~     block or intra-operative rectus sheath block under direct laparoscopic visualization. Both~     will be done by the attending pediatric surgeon. The patient, patient guardians, select~     research team members, and PACU staff will be blinded to the method of analgesic~     administration.~   "
81946|NCT02494323|"~     Seventy (70) subjects put on the Ness L300 System, a FES device for ankle dorsiflexion for~     patients with foot drop. Stimulation will be given through two different electrodes: the QFE~     which is a single channel stimulation, and the Segmented Electrode which is a dual channel~     electrode. The purpose of the dual channel stimulation is to enable a balanced dorsiflexion,~     with no inversion/eversion inclinations. Ankle elevation will be recorded both in a seated~     position and during gait. Subject preference will be recorded through BSW Questionnaire and~     Subjective Survey. Twenty first subjects will be stimulated with four different dual channel~     configurations. The configuration that shows to have an advantage over the others will~     continue to be evaluated on fifty additional subjects. Same procedure will be taken place, in~     addition ambulation tests will be performed.~   "
81947|NCT02494310|"~     A new mobile diagnostic and treatment unit is being developed by BCH to address the loss-to~     follow-up associated with the mobile screening program and demonstrate POC diagnosis by HRME.~     The mobile diagnostic and treatment unit will be equipped with the tools and infrastructure~     necessary to perform HRME, VIA, colposcopy, biopsy and treatment with cryotherapy. A team of~     a colposcopist, nurse, nursing assistant, and driver will staff the mobile diagnostic and~     treatment unit. The unit will travel to offer follow-up diagnostic and treatment services to~     women who have screened positive during a prior visit with the mobile screening unit. The~     mobile diagnostic and treatment unit will be constructed and maintained at BCH.~   "
81948|NCT02494297|"~     This study is designed to compile the reasons and specific indications for the prescription~     of Cyproterone Acetate combined with Ethinyl Estradiol by Health Care Providers. The primary~     objective of the study is to characterize the prescribing behaviors for Cyproterone Acetate~     combined with Ethinyl Estradiol in 5 European countries (Austria, Czech Republic, France, the~     Netherlands, and Spain), including:~        -  prescription indications for Cyproterone Acetate combined with Ethinyl Estradiol~        -  use of Cyproterone Acetate combined with Ethinyl Estradiol in accordance with the~          updated label~        -  concomitant use of Cyproterone Acetate combined with Ethinyl Estradiol and combined~          hormonal contraceptives~        -  second line treatment with Cyproterone Acetate combined with Ethinyl Estradiol for the~          indication acne~   "
81949|NCT02494284|"~     The purpose of this study is to compare short-term (6-month Dual Anti Platelet Therapy(DAPT)~     followed by clopidogrel monotherapy) vs. standard long-term dual antiplatelet strategies~     (24-month DAPT followed by aspirin monotherapy) on clinically relevant bleeding complications~     (Bleeding Academic Research Consortium(BARC) type 2, 3, or 5)31 in patients after~     zotarolimus-eluting stent implantation.~   "
81950|NCT02494271|"~     The purpose of this retrospective study was to evaluate the incidence of SSI after colorectal~     surgery under the general anesthesia by different general anesthetic technique: inhalation~     versus total intravenous anesthesia.~   "
81951|NCT02494258|"~     Rollover study supporting solid tumor and hematological disorder indications from Celgene~     sponsored CC-486 protocols eligible for participation in the study.~   "
81952|NCT02494245|"~     The aim of the study is to compare physical activity in stroke survivors who have undertaken~     a four month physical activity intervention using the STARFISH application with a control~     group receiving four months of usual care.~   "
81953|NCT02494232|"~     Thoracic traumas are frequent causes of emergency department admissions and the third most~     common cause of death from trauma. Although emergency management of major thoracic traumas~     that have high mortality and morbidity were discussed and well-understood in detail in the~     literature, there are limited information regarding diagnosis, emergency management,~     treatment and follow-up after discharge of patients with minor blunt thoracic traumas.~      The investigators aimed to investigate demographic data, physical examination findings, and~     the relationship between lung injury, emergency department final diagnosis, hospitalization,~     discharge and re-admission rates, effects of prescribed analgesics on pain and re-admissions~     of patients with a pre-diagnosis of minor blunt thoracic trauma on first admission.~   "
81954|NCT02494219|"~     Comparison of Immunochromatographic Test for rapid detection of group A streptococcal antigen~     with culture in Pediatric patients.~   "
81955|NCT02494206|"~     The purpose of this study is to assess the efficacy of QBX258, a compound developed by~     Novartis Corporation composed of two antibodies, in reducing arm volume excess in women with~     stage I-II breast cancer related lymphedema.~   "
81956|NCT02494193|"~     In deep carious lesions, presenting risk of pulp exposition, a treatment option is the~     partial caries removal of carious tissue followed by provisional restoration, while this~     approach is called indirect pulp capping. The aim of this double-blinding controlled~     randomized clinical trial is to evaluate the success of indirect pulp capping using only~     resin-modified glass ionomer, while the additional layer of calcium hydroxide was used as~     control. The sample of 112 molars and/or premolars (n=56), presenting deep carious lesions,~     from patients with age between 15 and 30 years treated in dental clinic at Department of~     Dentistry of Federal University of Sergipe. The selected carious lesions must be reached 2/3~     of dentin, observed in bite-wing radiography, without pulp involving and/or other factor that~     to compromise the evaluation. After detailed anamneses, the selected teeth will be~     radiographed e all carious tissue from surrounding walls will be removed. At the floor of~     cavity, the carious tissue will be partially removed using hand dentin excavators, remaining~     the caries-affected dentin and avoiding the pulp exposition. The removed carious tissue from~     the floor of cavity will be evaluated for presence of Lactobacilos e Estreptococos Mutans,~     while the remaining dentin will be evaluated for consistency, colour and humidity. Randomly,~     the cavity will be provisionally restored with: Control - dress and cement of calcium~     hydroxide followed resin-modified glass ionomer; or Experimental - only resin-modified glass~     ionomer. The distance between the base of restoration and the pulp cavity cap will be~     measured by bitw-wing radiography. The patients will be re-evaluated after 15 days, while the~     teeth with compromised pulp vitality will be excluded from the study. The remaining patients~     will be evaluated after 6 months. The distance between the base of restoration and the pulp~     cavity cap will be measured again, followed by provisional restoration removal. The remaining~     caries-affected dentin from floor of cavity will be fully removed and a bacteriological~     evaluation performed. The consistency, colour and humidity of this tissue will be evaluated~     too. Finally, the permanent restorations will performed.~   "
81957|NCT02494180|"~     The objective of the trial is to compare fentanyl and midazolam vs diazepam and pethidine in~     terms of the pain levels and post-operative side effects of TUGOR~   "
81958|NCT02494167|"~     This research study uses special blood cells called multiple tumor-associated antigen~     (TAA)-specific T cells (a new experimental therapy) to treat patients with acute myeloid~     leukemia (AML) or myelodysplastic syndrome (MDS) which has come back, or may come back, or~     has not gone away after standard treatment, including an allogeneic hematopoietic stem cell~     transplant (HSCT).~      The investigators have previously used this sort of therapy to treat Hodgkin or non-Hodgkin~     lymphomas that are infected with Epstein-Barr virus (EBV), the virus that causes infectious~     mononucleosis (mono or the kissing disease), Epstein Barr virus (EBV). EBV is found in~     cancer cells of up to half of all patients with Hodgkin and non-Hodgkin lymphoma. This~     suggests that it may play a role in causing lymphoma. The cancer cells infected by EBV are~     able to hide from the body's immune system and escape being killed. The investigators~     previously tested whether special white blood cells (called T cells) that were trained to~     kill EBV-infected cells could affect these tumors, and in many patients the investigators~     found that giving these trained T cells causes a complete or partial response.~      In several lymphomas and other types of cancer like AML or MDS, the cancer cells do not have~     EBV. The do however express other proteins that can be targeted in the same way. The~     investigators have been able to infuse such tumor-targeted cells into up to 10 patients with~     lymphoma who do not have EBV, and seen some complete responses. Importantly, the treatment~     appears to be safe. Therefore, the investigators now want to test whether the investigators~     can direct these special T cells against other types of cancers that carry similar proteins~     called tumor-associated antigens (TAAs). These proteins are specific to the cancer cell, so~     they either do not show up, or show up in low quantities, or normal human cells.~      The investigators will grow T cells from patients' stem cell donors in the laboratory in a~     way that will train them to recognize the tumor proteins WT1, NY-ESO-1, PRAME, and Survivin,~     which are expressed on most AML and MDS cancer cells. The cells will be infused at least 30~     days post-allogeneic stem cell transplant. In this study, the investigators want see whether~     these cells will be able to recognize and kill cancer cells that express these proteins.~     These donor-derived multiTAA-specific T cells are an investigational product not yet approved~     by the U.S. Food and Drug Administration~      The purpose of this study is to find the largest safe dose of donor-derived tumor protein~     multiTAA-specific T cells for patients with AML or MDS.~   "
81959|NCT02494154|"~     This study evaluates the work of breathing among patients under various conditions of~     treatment with high flow nasal cannulas. Sixteen spontaneously breathing patients with~     respiratory failure (hypercapnic or hypoxemic) will be included. The design of this study is~     a cross over of four treatment periods with different flow settings.~   "
81960|NCT02494141|"~     The proposed research will determine the effectiveness of curcumin for improving the health~     and function of arteries in children and young adults with autosomal dominant polycystic~     kidney disease (ADPKD). The study also will provide insight into how curcumin improves artery~     health by determining the physiological mechanisms (biological reasons) involved and offer~     exploratory evidence if curcumin can slow kidney growth. This will be done by comparing these~     measurements in children and young adults who are randomized to receive either curcumin or~     placebo for 1 year.~   "
81961|NCT02494128|"~     All parents in Sweden are offered group based parental support within Child Health Service~     (CHS) but only 40% participate. Nurses feel insecure in their group leadership and express a~     need for education in group leadership and group dynamics. Most CHC nurses do not have formal~     education or training in group leadership and the aim of this study was to evaluate a group~     based education program in group leadership for Child Health Care (CHC) nurses.~   "
81962|NCT02494115|"~     Physical embarrassment, pain and psychological impact linked to the body image distortion are~     often associated to these lymphedemas. Investigators decided to study new therapeutic method~     because of major discomfort due to these oedemas and doctors' difficulty to manage them.~      Subcutaneous drainage also called lymphocentesis seems to be an interesting technique. This~     local treatment consists in inserting in lower limbs several catheters draining into enclosed~     bags in order to evacuate lymph fluid and to lower local pressure.~      Very few studies have been published concerning this technique and are presenting only a~     small number of cases. They cannot allow clear conclusions of this technique's efficiency but~     show encouraging results.~      Investigators want to collect more data on this technique using a larger number of subjects~     in order to evaluate subcutaneous drainage effects on the comfort of palliative care cancer~     patients presenting lower limbs lymphedema. Investigators will consider as lymphedema,~     oedemas with no renal or cardiovascular identified cause and excluding anasarca.~   "
81963|NCT02494102|"~     The purpose of this study is to determine whether modafinil use in patients with obstructive~     sleep apnea will improve postoperative delayed emergence after general anesthesia.~   "
81964|NCT02494089|"~     Vulnerability to psychologic distress induced by in situ simulation.~      Objectives: Psychological evaluation at short and long term on working satisfaction, mental~     health, and acute stress after in situ simulation. Analysis of the stress vulnerability~     induced by simulation.~      Design: non interventional study.~      Primary outcome: Psychologic distress analysis with validated psychologic distress inventory~     (Job Satisfaction Survey (JSS), General Health Quality (GHQ), Impact of Event Scale Revisited~     (IESR), State-Trait Anxiety Inventory-A (STAI-A), State-Trait Anxiety Inventory -B (STAI-B)).~   "
81965|NCT02494076|"~     Asthma is a leading cause of emergency department (ED) visits for children. A novel way of~     treating asthma is the use of positive expiratory pressure (PEP). Positive expiratory~     pressure works by creating pressure in the lungs to keep airways open and to clear mucus from~     the lungs. PEP is already used in the treatment of asthma at the investigators institution,~     but studies evaluating the efficacy of PEP therapy in asthma exacerbations do not exist. This~     study plans to learn more about the use of PEP therapy in the treatment of asthma~     exacerbations in children in the emergency department. Specifically, the study aims to~     evaluate if PEP therapy reduces the severity of asthma exacerbations in children and if it~     reduces the need for additional therapies and admission to the hospital. This study will be a~     randomized control trial comparing children who receive standard therapy to those who receive~     standard therapy plus PEP therapy in the treatment of asthma exacerbations. Children age 2 to~     18 years presenting to the ED with moderate to severe asthma exacerbations will be included~     in the study. Reduction in clinical asthma severity will be measured by change in the~     Pulmonary Asthma Score (the respiratory severity score used at the investigators~     institution). The need for additional therapies and hospitalization will also be evaluated.~   "
81966|NCT02494063|"~     To evaluate whether a less radical surgical approach with sentinel lymph node biopsy is~     non-inferior to treatment with systematic pelvic lymphadenectomy.~      The null hypothesis is that the recurrence rate after SLN biopsy is non-inferior to the~     reference recurrence rate of 7 % (at the 24th month of follow-up) in patients after~     systematic pelvic lymphadenectomy, but that the less radical surgery is associated with~     significantly lower postoperative morbidity.~   "
82023|NCT02493322|"~     The purpose of this study is to evaluate the non-inferiority clinical efficacy of two~     different drug associations in the essential hypertension control.~   "
82064|NCT02492789|"~     This is an open-label, multicenter, non-randomized, dose escalation and tumor-expansion phase~     I trial to evaluate safety and tolerability of INCSHR01210 in patients with advanced solid~     tumors. The trial will enroll subjects with advanced solid tumor who have failed current~     standard anti-tumor therapies.~   "
81967|NCT02494050|"~     Anhedonia, characterized as (a) the diminished motivation to participate in activities,~     and/or (b) diminished enjoyment of a pleasurable activity are common symptoms among women~     diagnosed with mood disorders. This trial aims to test three treatments adapted to reduce~     anhedonia.~      The investigators will compare three treatment groups, specifically, two doses of Behavioral~     Activation treatment for anhedonia (i.e., 12 weeks vs. 8 weeks of BA) with an active~     comparator treatment, Bipolar Disorder Collaborative Care (12 weeks of BDCC). BA is a~     psychotherapy approach that helps participants to identify and modify environmental sources~     of their depression. BDCC is a supportive care approach that educates participants to~     optimize their medication initiation or their existing medication regimen. The time frame for~     this study will be between 12-14 weeks. Specifically, participants will be evaluated and~     enrolled within one week, then received up to 12 weeks of treatment (tracked through this~     time) and then complete two evaluations (one at week 8) and another at the end of treatment~     (an expected average of 12-14 weeks after enrolling into treatment).~      Primary analyses aim to compare the dose-mechanism change in BA relative to a standard~     medication optimizing protocol, BDCC. The secondary analyses are to evaluate individual~     differences in stated patient preferences for treatment, and group differences in treatment~     effect on anhedonia, side effects, and quality of life.~   "
81968|NCT02494037|"~     This study describes the three-year survival outcome of consecutively recruited advanced~     stage breast, colorectal, ovarian and pancreatic cancer patients receiving advanced~     integrative oncology (AIO) treatment at one of the participating North American advanced~     integrative oncology specialist clinics. This study also aims to describe AIO treatments~     recommended by naturopathic oncologists for these advanced stage cancer patients and pilot~     the collection and evaluation of health-related quality of life data on a subset of Canadian~     AIO-treated patients.~   "
81969|NCT02494024|"~     This study will evaluate the safety and tolerability (maximum tolerated dose (MTD) within the~     specified dosing range) of single intravenous (IV) infusion of C2N-8E12 in patients with~     progressive supranuclear palsy (PSP).~   "
81970|NCT02494011|"~     This study compared the effects of closed kinetic chain exercise and Russian current~     stimulation on pain, functional disability, wrist range of motion (ROM) and grip strength in~     patients with colles' fracture. Forty five patients with stable colles' fractures are~     randomly classified into three groups with fifteen patients in each group; Group I received~     traditional exercise in the form of; Mobilization, stretching exercises, range of motion~     exercises (passive and active) and edema control of the wrist joint. Group II stimulated by~     electrical Russian current in addition to traditional exercise. Group III received closed~     kinetic chain exercise (wall press, plyometric wall push up, Quadruped rhythmic~     stabilization, and Push up exercises) plus traditional exercise. All outcome measures~     including Pain, function, Wrist ROM, and grip strength were evaluated before and after the~     treatment program.~   "
81971|NCT02493998|"~     Mucopolysaccharidosis type IIIB (MPS IIIB, also known as Sanfilippo Syndrome Type B) is a~     severe neurodegenerative disorder. The purpose of this study is to learn more about the~     health problems in patients with MPS IIIB and how to measure these problems over time. It~     will particularly look at how the disease develops in young children. This is an~     observational study, so no experimental drug will be given. The results from this study will~     help us design future studies to measure whether these health problems get better when we~     give experimental drug for MPS IIIB.~   "
81972|NCT02493985|"~     The purpose of this study is to study the effects of carbon dioxide combined with head down~     tilt on cerebral physiology and anatomy. This paradigm will help establish a ground-based~     analog for spaceflight, and also evaluate the ability of non-invasive devices to monitor~     brain physiology.~   "
81973|NCT02493972|"~     This is a Multicenter prospective diagnostic study.~   "
81974|NCT02493959|"~     Peptide YY (PYY) is a gastrointestinal hormone released from the enteroendocrine cell upon~     food intake. The N-terminal truncated form, PYY3-36, exerts anorexic effects. In this study~     we want to investigate the kinetics of PYY1-36 and PYY3-36 and to examine whether a~     C-terminally degraded metabolite, PYY3-34, is formed after infusion of PYY.~   "
81975|NCT02493946|"~     The purpose of the protocol is to demonstrate the safety and the efficacy of a single~     injection of a new formulation of Clostridium Botulinum toxin type A haemagglutinin complex~     (BTX A HAC NG) to improve the appearance of moderate to severe glabellar lines (the lines~     between the eyebrows) and to assess the long term efficacy and safety of BTX-A-HAC NG after~     repeated injections.~   "
81976|NCT02493933|"~     To evaluate the effect of oral Phytoestrogen or Isosorbid mononitrate or N-acetyl cysteine as~     an adjuvant to clomiphene citrate on induction of ovulation and pregnancy outcomes in~     patients with PCOS. In this three-arm open RCT, 240 PCOS infertile women were randomly~     divided to 3 groups for induction of ovulation. Group A, [PE group, n= 80] patients received~     CC 100mg/d plus oral Phytoestrogen120 mg/ day and patients in Group B, [ISMN group, n=80]~     received CC 100 mg/d plus 20 mg Isosorbid mononitrate and Group C, [NAC group, n=80] patients~     received CC 100 mg/d plus NAC 1200 mg/day.~   "
81977|NCT02493920|"~     Lung protection should start in the delivery room where, from the first breaths, the preterm~     infant can be helped to clear the lung fluid and to recruit alveolar spaces and establish the~     functional residual capacity (FRC). Sustained lung inflation (SLI) applied at birth in the~     delivery room has been demonstrated to lead to clearance of lung fluid and achievement of a~     precocious functional residual capacity (FRC) both in animal and human studies. SLI~     associated to an adequate positive end expiratory pressure (PEEP) may help the efficacy of~     the respiratory effort in lung of preterm infants at risk for respiratory distress syndrome~     (RDS) and reduce need of mechanical ventilation (MV).~      Further studies are required to evaluate the clinical utility of this maneuver. The ability~     to monitor what happens to the lungs while applying different recruitment maneuvers in~     preterm infants would allow the definition of a procedure that allows optimal assistance to~     improve the FRC. One promising approach is provided by the forced oscillation technique~     (FOT). During forced oscillations, a small amplitude sinusoidal pressure stimulus is applied~     to the airway opening and the mechanical response of the respiratory system is studied by~     means of the total respiratory input impedance (Zin). Zin is a complex number that can be~     expressed as real part, called resistance (Rrs), and imaginary part, called reactance (Xrs).~     Particularly, it has been recently shown that Xrs measured at 5 Hz is very sensible to~     changes in the mechanics of lung periphery and provides accurate information about lung~     volume recruitment and derecruitment. The main purpose of this work is to apply FOT to the~     assessment of lung function in newborns submitted to SLI at birth. The investigators~     hypothesized that the application in the delivery room of the SLI in the preterm infant is~     effective in achieving a greater FRC and therefore a greater value of Xrs compared to a~     control group not treated with the SLI.~   "
84229|NCT02464527|"~     The purpose of the current study is to deliver the SSP procedure to children diagnosed with~     autism that do not have vocal language. The study will also aim to gather data in the natural~     environment using a voice recorder.~   "
81978|NCT02493907|"~     Cardiac resynchronization therapy (CRT) is a well-established treatment for patients with~     severe systolic heart failure (HF) and ventricular desynchronization. Despite the~     consistently observed structural and functional improvements as well as reductions in HF~     events and mortality in large multicenter randomized trials, 30% patients remain classified~     as nonresponders. Present evidences showed that QRS duration was the most effective parameter~     to predict responsivity of CRT in patients with severe HF. But some studies showed that QRS~     duration could be influenced by obesity and gender. Accordingly, the simple QRS interval~     width of body surface electrocardiograph should not be the most satisfactory parameter for~     screening patients suitable for CRT. Recent study showed that left ventricular electrical~     delay, as measured by the time from the onset of QRS to the LV electrogram peak (QLV),~     predicted CRT response. At long QLV intervals, atrioventricular optimization (AVO) can~     increase the likelihood of structural response to CRT. However, it is unclear whether it is~     suitable for Chinese patients. The investigators would like to validate this relation in a~     Chinese population and explore if a corrected QLV might do better to predict the responsivity~     of CRT.~   "
81979|NCT02493894|"~     Now a days, due to the change in lifestyle, the extended lifespan and the increase in the~     rate of the road accidents, the need for surgical operation of spinal instrumentation has~     been increased. And these surgeries are the most crucial part of neurological surgery wards.~     The everyday improvements in the quality of equipment used and advancements in surgical~     methods lead to best performance of these procedures and finally the higher quality of~     patients' lives. The procedures of Laminectomy and pedicular screw instrumentation lead to~     pain relief and better performance and developments in the quality of patients' lives.~      In addition to the above mentioned improvements, you must consider the fact that these~     activities are still accompanied by complications during and after surgical operation.~      Nerve root injury, Thecal sac tearing, injury to the spinal cord and the inappropriate~     sagittal balance are the most significant side effects during spinal surgery.~      One of the most important complications during and after these surgeries is perioperative~     bleeding that causes problems both for the patients and the surgeon.~   "
81980|NCT02493881|"~     The investigators hypothesized that, sometimes the posterior branch of the recurrent~     laryngeal nerve may also have motor function. The investigators aimed to evaluate motor~     function of the branches in the branching recurrent laryngeal nerves in this study.~   "
81981|NCT02493868|"~     The purpose of this study is to assess the efficacy of intranasal esketamine plus an oral~     antidepressant compared with an oral antidepressant (active comparator) plus intranasal~     placebo in delaying relapse of depressive symptoms in participants with treatment-resistant~     depression (TRD) who are in stable remission after an induction and optimization course of~     intranasal esketamine plus an oral antidepressant.~   "
81982|NCT02493855|"~     To evaluate the effect of ribavirin on second phase plasma hepatitis C virus (HCV)~     ribonucleic acid (RNA) decline in participants who receive ombitasvir/ABT-450/ritonavir and~     dasabuvir with full dose ribavirin, low dose ribavirin or without ribavirin for 2 weeks in~     treatment-naive HCV genotype (GT) 1a-infected adults.~   "
81983|NCT02493842|"~     Background:~      Phantom limb pain (PLP) develops in 50-80% of subjects who have a limb amputated. It is not~     well known what causes PLP to develop and the current treatments have been shown to be~     largely ineffective. Resent research, however, have indicated that cortical reorganizing~     occurring after amputation of the cortex areas related to the missing limb may be related to~     the development of PLP. Furthermore, the research indicated that by providing meaningful~     sensory input coming from the phantom limb the PLP may be alleviated and the cortical~     organization normalized.~      Aim:~      The CIP described in the current application, is part of a the EU-project EPIONE, which~     aims to investigate if and how cortical normalization and PLP alleviation can be induced by~     providing phantom limb sensations (sensations which seems to originate from the missing limb)~     in hand amputated subjects.~      Method:~      In the current study, which will take place at Aalborg University Hospital (AUH), 2-4 hand~     amputated subjects experiencing severe PLP will implanted with interneural nerve electrodes~     in the arm stump for up to one year.~      Therapy will be evaluated in two stages, first during a standardized four week phase where~     the subject receives daily therapy. If the therapy is shown to be effective, therapy may be~     reinitiated during a second longer therapy phase.~      During the therapy sessions, selective nerve stimulation will be performed. The amputee will~     experience this as sensations (movement, touch, temperature, vibration etc.) originating from~     the phantom limb. While implanted, we will investigate how well we can induce these~     sensations and we will provide a stimulation therapy, which consist of stimulation activities~     which requires the subject to focus on the evoked sensations. Prior to, during a and~     following therapy a series of assessments (standardized across all EPIONE partners to enable~     comparison) will be conducted to relate therapy with PLP, cortical organization, the mental~     state etc. of the subject.~      Expected outcome:~      The stimulation therapy is expected to alleviate PLP and induce cortical normalization. The~     experience we gain might be used for deriving clinical guidelines on how to treat PLP.~   "
81984|NCT02493829|"~     The study will be an open label, single arm, phase I study intended to identify the safety~     and tolerability of AML Cell Vaccine given to eligible MDS RAEB-2 and AML patients who have~     achieved a best response of complete remission or partial remission following their first or~     second course of standard induction chemotherapy.~   "
81985|NCT02493816|"~     Recessive dystrophic epidermolysis bullosa (RDEB) is a severe form of blistering skin disease~     caused by mutations in COL7A1 gene. This study aims to assess the safety of intradermal~     injections of gene-modified autologous fibroblasts in 5-10 adults with RDEB.~   "
81986|NCT02493803|"~     The aim of this research is to investigate the impact of dietary advice on the progression of~     tooth wear over 6 months using a randomised clinical trial design. Participants with severe~     tooth wear will be recruited. Half of those patients will receive a detailed dietary advice~     and the other half will be receive standard of care dietary advice. Moulds will be made of~     their mouths at the original appointment and 6 months later. These moulds will be scanned and~     superimposed to see if there is any difference in their level of tooth wear~   "
81987|NCT02493790|"~     Chronic Obstructive Pulmonary Disease (COPD) is a respiratory disease starting point~     characterized by multiple systemic effects as cognitive dysfunction. This one seems to have~     an impact in activity daily living, considered mainly as a cognitive-motor dual task~     situations. Yet to date, no study has specifically focused in the cognitive-motor performance~     in patients with COPD or on the effects during a rehabilitation program. The main objective~     of this work was to evaluate the impact of cognitive dysfunction in COPD, comparing~     performance between COPD patients and healthy subjects in a single and dual task~     cognitive-motor situation. The secondary objective was to assess the impact of a~     rehabilitation program on these performances.~   "
81988|NCT02493777|"~     This Phase 3 pivotal efficacy trial will examine the effects of HLD200 (methylphenidate) in~     patients aged 6-12 years with ADHD in a laboratory classroom setting. This study has a 6-week~     open-label treatment optimization period followed by a one week randomized, double-blind,~     placebo-controlled test phase.~   "
81990|NCT02493751|"~     This is a Phase 1b, open-label, multi-center, multiple-dose trial designed to estimate the~     maximum tolerated dose (MTD) and select the recommended phase 2 dose (RP2D) of avelumab~     (MSB0010718C) in combination with axitinib (AG-013736). Once the MTD of avelumab administered~     in combination with axitinib is estimated (dose finding portion), the dose expansion phase~     will be opened to further characterize the combination in term of safety profile, anti tumor~     activity, pharmacokinetics, pharmacodynamics and biomarker modulation.~   "
81991|NCT02493738|"~     Study Objectives:~        -  To evaluate the pharmacokinetics (PK) of orally administered Lozanoc under fasted and~          fed condition in healthy male subjects~        -  To compare the pharmacokinetics (PK) of orally administered Lozanoc and Sporanox under~          fed condition in healthy male subjects~        -  To evaluate the safety and tolerability of single oral dose of Lozanoc and Sporanox in~          Korean healthy male subjects~   "
81992|NCT02493725|"~     Guillain-Barré syndrome (GBS) is an immune-mediated polyneuropathy that usually follows an~     antecedent infection and causes acute neuromuscular paralysis. GBS is currently classified~     into the two major subtypes: a classical demyelinating type and axonal variant type. Whereas~     in Europe and North America demyelinating GBS is the major subtype, in East Asia and Central~     and South America, axonal GBS is found in 30~65% of patients. Although the pathophysiology of~     GBS has not been fully understood, major advances have been made in understanding the~     pathophysiology particularly for the axonal form of GBS. It is now established that axonal~     GBS is caused by molecular mimicry of human gangliosides by the Campylobacter jejuni~     lipo-oligosaccharides. Autoantibodies bind to GM1 or GD1a at the nodes of Ranvier, activate~     complements, and disrupt sodium channel clusters and axo-glial junctions, resulting in the~     nerve conduction failure and muscle weakness. C. jejuni infection induces production of~     antibodies, which cross-react with gangliosides on the human nerve axolemma, and activate the~     complements, resulting in formation of membrane attack complex (MAC). The pathology leads to~     axonal degeneration.~      The standard treatments for GBS are plasma exchange and intravenous immunoglobulin and the~     disease progression reaches its nadir within 4 weeks. However, during the acute phase, 18-28~     % of the patients require artificial ventilation and 4.1-6.3 % of the patients die of~     complications. Recovery takes several months or years, and 16.7-19.7 % of the patients still~     require aid to walk one year after onset. Because of such serious disability of GBS patients,~     an alternative novel therapy that can prevent death during acute phase or severe sequelae is~     needed.~      Eculizumab is a humanized monoclonal antibody of murine anti-human C5 antibody and~     specifically binds to the final activation complement component C5 and inhibits MAC formation~     by suppressing the cleavage reaction of C5 into C5a and C5b. The efficacy of eculizumab~     against GBS has been shown in a model of axonal GBS. At present, there are no animal models~     of demyelinating GBS. However, autopsy studies have shown that C3d and C5b-9 (MAC) are~     deposited on the Schwan cells, and therefore eculizumab can be effective also for~     demyelinating GBS.~      This clinical trial will be conducted to investigate the efficacy and safety of eculizumab~     for GBS to warrant future global clinical trials. Moreover, we also study the relationship~     between the efficacy and clinical subtypes of GBS, such as axonal or demyelinating form. Our~     trial will provide insights on whether the future global developmental plan should target the~     whole spectrum of GBS world-wide or focusing on Asia and South America.~   "
81993|NCT02493712|"~     IBD98-M-2002 is a phase 2a , Randomized, Double blind, Placebo-controlled of IBD98-M Delayed~     Release capsules in subjects with Mild to Moderately Ulcerative Colitis to investigate the~     clinical efficacy of IBD98-M delayed release capsules (in a fixed combination) over a 6-week~     treatment period and 2 weeks follow up.~   "
81994|NCT02493699|"~     The purpose of the present study was to determine whether teaching Karate techniques training~     leads to reduction in communication deficit of children with autism spectrum disorders.~   "
81995|NCT02493686|"~     Examination of the bone conduction of persons which according to the pure tone audiogram have~     a normal age related hearing threshold in the air conduction.~   "
81996|NCT02493673|"~     Obstructive sleep apnoea (OSA) is a highly prevalent sleep-related breathing disorder~     associated with adverse cardiovascular outcome. Underlying mechanisms are subject of debate.~     A causal relationship between OSA and systemic hypertension as well as peripheral endothelial~     dysfunction was shown, and there is accumulating evidence from physiologic and observational~     studies that cerebral autoregulation is insufficient to protect the brain from the nocturnal~     consequences of OSA. However, there are no data from randomised controlled trials proving a~     causal relationship between OSA and impaired cerebral vascular reactivity (CVR). The aim of~     this randomised controlled trial is to study the effects of a short-term CPAP withdrawal, and~     thus returning OSA, on daytime CVR and brain oxygenation to establish whether there is a~     causal relationship between OSA and cerebral vascular damage.~   "
81997|NCT02493660|"~     A pivotal study to assess the safety and effectiveness of the InSpace™ device implantation in~     comparison to surgical repair of full thickness Massive Rotator Cuff Tear (MRCT).~   "
81998|NCT02493647|"~     This study tests a 12-episode Internet-based, guide enhanced Love, Sex, & Choices (LSC) HIV~     prevention soap opera video series for smartphones or computers, in a randomized clinical~     trial among predominately at-risk African American urban women.~      The following hypotheses are to be tested: 1) The LSC treatment arm will show lower~     unprotected sex risk, meaning lower frequency of unprotected sex (vaginal + anal) with high~     risk partners at 6 months post intervention compared to an attention control arm 2) The LSC~     treatment arm will show higher participation in HIV testing at 6 months post intervention~     compared to the control.~      If effective, this video intervention could be rapidly implemented and brought to scale at~     low cost via the Internet, widely reaching young urban women with the goal of reducing HIV~     risk behavior and increasing HIV testing.~   "
81999|NCT02493634|"~     This is post-market clinical follow-up study on 25 consecutive patients in two centers to~     evaluate the safety and performance of magnetic resonance imaging conditional guide wire and~     the acceptability of identified risks in the clinical evaluation and to detect emerging risks~     on the basis of factorial evidence.The procedure will be done in patients with a clinical~     indication for cardiac magnetic resonance and conventional catheterisation.~   "
82000|NCT02493621|"~     The goal of this retrospective chart review is to evaluate if the implementation of lumbar~     plexus block placement for postoperative pain have improved conditions in the postoperative~     period for patients undergoing total hip arthroplasty when compared to the placement of~     epidurals for postoperative pain management.~   "
82001|NCT02493608|"~     The objective of this study is to compare scalpel vs. diathermy in abdominal wall incision in~     pregnant patients undergoing repeat elective cesarean delivery.~   "
82024|NCT02493309|"~     The purpose of this study is to determine whether an individuals cardio-respiratory fitness~     level can protect them from the negative metabolic impacts of prolonged sitting time.~      Overall, it is hypothesised that in individuals with high fitness, the unfavourable effect of~     prolonged sitting (build up of sugar, fat and insulin in the blood following a meal) will not~     be as substantial, nor will light activity breaks be as advantageous, compared to individuals~     with lower fitness as they have a smaller scope for metabolic improvement.~   "
82002|NCT02493595|"~     The study will seek to understand the effective use of a novel Microwave Radar Breast Imaging~     System in a Symptomatic Breast Care Clinic. The MARIA Imaging system uses low level~     non--ionising radiation (radio wave) signals to scan the breast tissue volume and to provide~     a visual image of areas of varying tissue permittivity value within the volume. These areas~     of varying permittivity can be shown as a two or three dimensional image and used in~     conjunction with the X-Ray mammogram and ultrasound scans to provide another level of~     diagnosis to the radiologist.The system works equally well in both dense and lucent breast~     types and can in particular provide insight into the diagnosis in dense tissue cases. The~     trial will accept symptomatic cases with suspected cancer, cysts or fibroadenoma.~      The trial will use the images produced by the MARIA system and compare them to the images~     obtained using X-Ray mammography. The results of the comparison will be assessed to~     understand the effectiveness of the MARIA image in assisting with the identification and~     location of suspected lesions for further specific analysis using Ultrasound/Biopsy.~   "
82003|NCT02493582|"~     The purpose of this study is to evaluate the safety and efficacy of Apatinib combined with~     cytokine-induced killer cell (CIK) vs Apatinib alone as the third line therapy for advanced~     lung adenocarcinoma patients with wild-type EGFR~   "
82004|NCT02493569|"~     The purpose of the study is to study the epidemic features and diagnosis of female breast~     cancer, especially the diagnosis and treatment of breast cancer.The disease-free survival~     (DFS) and the total survival time(OS) of the breast cancer patients will also be studied.~   "
82005|NCT02493556|"~     Introduction: The effects of Low Level Laser Therapy (LLLT) on exercise-induced muscular~     damage have been studied over the last years. Studies have been conducted on animals and~     humans in order to try to show the benefits of the intervention, but there is still~     conflicting evidence about its protective and therapeutic effects.~      Objectives: To describe the effects of LLLT on pain, strength and muscular inflammation after~     plyometric exercise.~      Methods: A randomized, double-blinded, placebo-controlled trial with participation of 20 male~     healthy volunteers will be performed. Healthy and physically active individuals, aged between~     18 and 35 years, with no history of injury on the lower limbs or contra-indications to~     maximal exercise performance will be included. A protocol of 10 series with 10 repetitions of~     the countermovement jump will be used to induce muscle damage at the lower limbs. Immediately~     before or after the exercise protocol, LLLT will be applied on one lower limb, while the~     other will receive placebo treatment. Phototherapy will be applied with an equipment of 810nm~     and a cluster with 5 diodes on 8 different points of the knee extensor muscle, totalizing a~     dosage of 240J. The placebo treatment will be held on the same way, but the equipment will be~     turned off. The volunteers will be evaluated at baseline (before the exercise protocol) and~     at follow-up of 24, 48 and 72 hours. The following outcomes will be evaluated: knee extensors~     isometric peak torque by Isokinetic Dynamometer, pain by Visual Analogue Scale and muscular~     tissue echo intensity by Ultrasonography.~   "
82006|NCT02493543|"~     The purpose of this study is to determine the autoantibody profiles after spinal cord injury~     and their role in spontaneous functional recovery.~   "
82007|NCT02493530|"~     This is a Phase 1, open-label, study of TGR-1202, a PI3K delta inhibitor, administered~     together with ruxolitinib in patients with myeloproliferative neoplasms (specifically:~     polycythemia vera, primary myelofibrosis, PPV-MF or PET-MF) and MDS/MPN.~   "
82008|NCT02493517|"~     The purpose is to compare the efficacy and safety of lanreotide autogel® 60mg, 90mg or 120mg~     with lanreotide 40mg PR in subjects with active acromegaly.~   "
82009|NCT02493504|"~     Arteriovenous fistula (AVF) is now the optimal method of obtaining vascular access for~     dialysis. Measures such as systemic anticoagulation have been proposed as means of increasing~     patency rates but enough evidence does not exist to support their use. The investigators~     aimed to evaluate the efficacy of preoperative heparin injection on patency of AVF during the~     first 24 hours after surgery and to determine whether such measure can be used to prevent~     early thrombosis of the vascular access.~   "
82010|NCT02493491|"~     The Neurogenic Dysphonia/Dysphagia Registry is designed to be purely observational (i.e.~     non-interventional, exploratory). Patient data collected from the registry is expected to be~     consistent with any information which can be obtained during usual care of patients with~     dysphonia/dysphagia treated with vocal fold augmentation.~   "
82011|NCT02493478|"~     Advanced airway interventions are common high risk, high stakes events for children in~     intensive care units (ICU) and emergency departments (ED), with risk for life and health~     threatening consequences.~   "
82012|NCT02493465|"~     This is a prospective, open label, single-center study, in kidney transplant recipients with~     stable renal function for 12 and 120 months after transplantation, that are in use use of~     calcineurin inhibitors, azathioprine, and prednisone. The prevalence of left ventricular~     hypertrophy will be investigated before and after conversion of azathioprine to everolimus.~      This study will evaluate as primary objectives: the prevalence of left ventricular mass~     hypertrophy in renal transplant recipients with azathioprine therapy. And assess the ability~     of everolimus to reduce left ventricular mass after conversion from Azathioprine, using~     sensitive methods such as MRI. And as secondaries objectives: Renal function (measured GFR)~     at 3 and 6 and 12 months after conversion, number and severity of episodes of acute rejection~     proven by biopsy, and the proteinuria at 3, 6 and 12 months after conversion.~   "
82013|NCT02493452|"~     This study in patients with IBS-C is a randomized, double-blind, placebo-controlled,~     parallel-group clinical trial with 12 weeks of study drug therapy.~   "
82014|NCT02493439|"~     This study aims to test the efficacy of an intervention focused on promoting positive~     emotions (Best Possible Self - BPS) to improve the psychological wellbeing of Romanian~     immigrants living in Spain. It is hypothesized that the BPS intervention will significantly~     improve a series of positive mental health outcomes, i.e., optimism, future expectancies, and~     affect, compared to the Control group.~   "
82025|NCT02493296|"~     The present study will investigate the effect of artificially stiffening the aorta by means~     of an aortic stent on central aortic haemodynamics (CAH). This study will determine whether~     aortic stenting inadvertently adversely impacts on CAH, thereby providing the rational for~     subsequent therapeutic intervention to reduce the associated cardiovascular risk.~   "
82015|NCT02493426|"~     Autism spectrum disorder (ASD) is a group of severe, life-long developmental disorders.~     Oxytocin (OT) is a neurohormone involved in both repetitive/rigid and social behaviors. This~     study is focusing on how a single dose of intranasal OT (IN-OT) affects cognitive rigidity~     and social perception tasks. Taking OT as a spray through the nose increases social and~     decreases repetitive behavior in some adults with ASD, and we are exploring if it helps~     children with ASD similarly. However, it is unclear whether every person with ASD has an~     abnormal OT level, and if OT affects restrictive or social behavior differently.~     Consequently, we aim to study whether OT treatment can be effective in treating subgroups~     with specific features of ASD. We will use approaches utilizing both behavioral and~     physiological responses to clarify the role of OT in ASD. We will develop a deeper~     understanding of the range of social and rigid behaviors and use that information to identify~     persons with ASD who would benefit from OT treatment. Potential subjects will be asked if~     they want to participate in two sessions in our clinical laboratory where they will get~     either single dose IN-OT or placebo. After receiving the substance, they will be asked to do~     a handful of tasks while we monitor heart rate, eye movements, and collect baseline and post~     intranasal blood, urine and saliva. The levels of hormones, metabolites and peptides related~     to or interacting with OT will be measures in the collected samples of blood plasma, urine~     and saliva. Additionally DNA will be extracted from the blood samples to study genes related~     to OT and ASD.~   "
82016|NCT02493413|"~     The purpose of the study was to analyze negative affectivity (NA) and social inhibition (SI)~     inquired by DS14 score in type D personality (distressed personality) to the relation of~     autonomic regulation of heart function (HRV) and immune response (T lymphocyte) among obese~     patients within coronary heart disease group (CHD). As stress is the key psychological~     activator of the hypothalamic-pituitary-adrenal axis (HPA axis) and therefore an important~     risk factor for diminished immune competency and prevalence of chronic conditions such as~     obesity, investigators chose exercise as the stress release intervention, especially as~     chronic stress may have a role in obesity, related to initiation or exacerbation of the~     condition. Abnormal regulation of the hypothalamic-pituitary-adrenal axis is additionally~     associated with chronic inflammatory conditions. Proinflammatory T-lymphocytes are present in~     visceral adipose tissue and may contribute to local inflammatory cell activation before the~     appearance of macrophages, suggesting that these cells could play an important role in the~     initiation and perpetuation of adipose tissue inflammation.~   "
82017|NCT02493400|"~     To investigate the effect of exercise or PAP prescription 3 months after completion of the~     study Should elderly patients with atrial fibrillation be offered physiotherapist group~     exercise or can physical activity on prescription (PAP) be used as an alternative? regarding~     level of physical fitness, physical activity, heart rate and health related quality of life~     (HR-QoL). Also if any of the investigated variables can predict the possible change in~     physical fitness.~   "
82018|NCT02493387|"~     Atrial fibrillation is the most common arrhythmia, and physical activity and exercise are~     sometimes avoided due to symptoms such as palpitations, fatigue and anxiety.~     Physiotherapist-led group based exercise as part of cardiac rehabilitation is rare for this~     group of patients, the method physical activity on prescription is used to encourage the~     patient to increase their physical activity level in order to reduce the risk of premature~     morbidity and mortality. However, mostly in this method you do not know the patient's ability~     to perform the prescribed amount of physical activity, and its effect on physical fitness has~     not been studied in patients with heart disease, neither has the effect of physiotherapist~     led group-based exercise in patients with atrial fibrillation. The aim was to investigate the~     impact of physiotherapy led group-based exercise compared to physical activity on~     prescription in patients with atrial fibrillation regarding the level of physical fitness,~     physical activity, heart rate and health related quality of life (HR-QoL).~   "
82019|NCT02493374|"~     This is a study of people with type 2 diabetes and high cholesterol between age 18 and 65.~     This study is trying to figure out if a partial bypass of the small intestine can reverse~     type 2 diabetes for people who require cholesterol lowering and who cannot tolerate the~     statin drugs.~   "
82020|NCT02493361|"~     This is a multicenter, Phase II, open-label, 42-patient single-arm trial of intratumoral~     pIL-12 EP in combination with pembrolizumab in patients with melanoma. Patients will be~     evaluated in 2 parts. Part A patients will be selected using a flow cytometric assay that~     quantifies intratumoral PD-1hiCD8+CTLA4+ exhausted lymphocytes in the tumor. Part B will~     enroll patients who have or are failing pembrolizumab at least 12 weeks after starting PD-1~     antibody alone or in combination, or, who have been selected using a flow cytometric assay~     that quantifies intratumoral PD-1hiCD8+CTLA4+ exhausted lymphocytes in the tumor.~   "
82021|NCT02493348|"~     Fibromyalgia is a chronic pain disorder associated with widespread pain that dramatically~     impacts patient's quality of life. Its exact cause has not yet been identified, however~     recent studies have indicated that fibromyalgia is associated with significant imbalance of~     the connectivity within brain networks associated with pain, decreased functional~     connectivity in the descending pain-modulating system, and increased activity in the pain~     matrix related to central sensitization. It has been suggested, therefore, that treatments~     that induce coherent neuronal activity, and/or stimulate synchronization of dysregulated~     brain circuitry, have significant benefits, improving pain management and enhancing patient's~     quality of life. Rhythmic Sensory Stimulation (RSS) is an example of a non-invasive treatment~     that is thought to indirectly stimulate neuronal coherence. The present research proposal~     aims to determine the effectiveness of Rhythmic Sensory Stimulation with 40 Hz sound on the~     treatment of fibromyalgia. The proposed treatment involves 30 minutes of daily rhythmic~     vibroacoustic stimulation at 40 Hz, 5 days per week, for 5 weeks. The treatment is~     self-administered by the patients at home with the Sound Oasis Vibroacoustic Therapy System~     (VTS) 1000 portable device. Measures of pain severity, fibromyalgia symptoms, sleep quality,~     and depression, will be compared before and after treatment between the treatment and control~     groups. The results of the present study will help to better understand the effectiveness of~     Rhythmic Sensory Stimulation to the treatment of chronic pain disorders, such as~     fibromyalgia, and contribute to the development of future studies to investigate the neural~     driving effects of therapies based on Rhythmic Sensory Stimulation.~   "
82022|NCT02493335|"~     The purpose of this study is to prove the superiority of a 48-weeks treatment with budesonide~     orodispersible tablets versus placebo for the maintenance of clinico-pathological remission~     in patients with eosinophilic esophagitis.~   "
82026|NCT02493283|"~     The objectives of the study are~        -  to evaluate pharmacokinetics, distribution in blood leucocytes, metabolism and~          methemoglobinemia after single-dose and repeated-dose administration of 100 mg of~          dapsone in healthy subjects genotyped for CYP2C9 and NAT2~        -  to evaluate serum through levels, distribution in blood leucocytes and methemoglobinemia~          after repeated-dose treatment with dapsone in patients with autoimmune bullous~          dermatoses before and after concomitant treatment with glucocorticoids~   "
82027|NCT02493270|"~     The aim of this prospective study is to verify the efficacy of smoking cessation on~     non-surgical periodontal therapy in adult subjects with chronic periodontitis.~      Smokers that were willing to quit received periodontal treatment and concurrent smoking~     cessation therapy. Periodontal maintenance was performed every 3 months. A calibrated~     examiner, blinded to smoking status, assessed periodontal status, gathered demographic and~     behavioural information with a structured questionnaire and measured air carbon monoxide~     concentration measurements.~   "
82028|NCT02493257|"~     The proposed study seeks to investigate the effect of intranasal capsaicin treatment in~     patient with Non-allergic irritant rhinitis (NAIR), as well as evaluate optical rhinometry~     (ORM) as a means to quantify symptomatic improvement in NAIR patients during and after~     treatment.~   "
82029|NCT02493244|"~     Tears play a vital role in vision. A thin layer of tears is always present to cover the~     surface of the eye for optimal comfort and vision. There are several layers to the tear film,~     and the outer most layer is comprised of lipids. This lipid layer prevents evaporation of the~     tears and may be disrupted in people suffering from symptoms of dry eye. Cleaning eyelids~     with Cliradex wipes have shown to be effective in reducing dry eye symptoms in some patients,~     and the purpose of this study is to evaluate the tear film lipid layer thickness before and~     after one months treatment with Cliradex Wipes.~   "
82030|NCT02493231|"~     Many anesthesiologists use the Remifentanil for reducing a surgical pain and stabilizing a~     vital sign. However, this drug induce postoperative hyperalgesia. Nowadays, many studies~     report that low-dose Ketamine prevents the opioid-induces hyperalgesia. Nefopam,which is~     non-opioid analgesic, has similar mechanism with Ketamine. It will be helpful for~     postoperative pain control, and reduce the needs of opioid.~   "
82031|NCT02493218|"~     Effective strategies to ameliorate the negative effects of stressful urban living are greatly~     needed. D-Stress Baltimore (DSB) is an evidence-based mindfulness-based instructional program~     of stress-reduction techniques, found to reduce mental health problems across many adult~     populations.~      The investigators propose to conduct a randomized controlled trial of the 12-week~     school-based DSB program compared with a 12-week school-based health education control~     program at Elev8 schools among 5th-8th graders to assess if DSB program is beneficial for~     mental health and behavioral problems among public middle-school students.~   "
82032|NCT02493205|"~     The Holding Area LINQ Trial is a clinical trial designed to compare the benefits in~     conducting impant procedures in the holding area of a hospital operating room vs cardiac~     catheterization/electrophysiology laboratory.~   "
82033|NCT02493192|"~     The study was performed at Gregorio Marañón Hospital birth centre. A Randomised Clinical~     Trial comparing the two methods of pain relief in the first time of labour was carried out.~     In this study, 110 women in the first stage of labour were allocated in two study groups by a~     randomised block design. One of them used the birth ball as a pain relief method,and the~     other one used pethidine and haloperidol injection.~   "
82034|NCT02493179|"~     The purpose of this study is to examine the efficacy of dose regimen of serratiopeptidase~     (serodase 5 mg) as a prospective, randomized, parallel, double blind Placebo- controlled~     study.~   "
82035|NCT02493166|"~     Multiple sclerosis (MS) is a chronic, inflammatory, neurodegenerative disorder of the central~     nervous system, with more than 2.5 million people in the world. It is the most non-traumatic~     cause of disability in young and middle-aged adults.~      Because the lesions are spread in the brains, there is a variety of symptoms. The most common~     symptom is the typical motor dysfunction. 66% of persons with MS, and even 81% of them after~     15 years, have problems with movements in one or both upper extremities.~      Also, 40 untill 70% of persons with Multiple Sclerosis have cognitive impairment. Although~     they are less visible, they can have a major determining influence on social or work-related~     domains. The most frequent cognitive dysfunctions are sustained attention, reduced speed of~     information processing, impaired memory and limited executive functions.~      When a combination, of motor and cognitive task, is asked, the execution of these tasks could~     be difficult with the foregoing in mind. For example problems during chatting while cooking,~     typing a report at a meeting or watching television while ironing.~      The dual-task paradigm assumes that the attention should be divided between two simultaneous~     tasks. A dual task cost (DTC) is a restriction in performance on each task, compared whit the~     separate task versus simultaneously.~      Research on dual tasking with persons with MS has already studied extensively, but not~     specific on the upper limb. In 2015 Learmonth, Pilutti and Motl published an primary research~     on the DTC. They combined the movements of the upper limb with a cognitive task. The research~     showed a difference between Persons with MS and the control group. At methodological level,~     there is lacking on the randomization of tasks. That is an important bias because of the~     learning effect of the tasks. They used only one task for the upper limb; this isn't enough~     to generalize the concept of motor interference in Persons with MS.~      The study has two research questions:~        -  Have Persons with MS a greater DTC compared with a healthy control group? The motor task~          is executed with the upper limb.~        -  Is there a difference on DTC in persons with MS depending on the motor task?~      This research is an observational case-control study in which individuals with MS will be~     compared to a healthy control group. They will be two moments of assessments. On the first~     day the general performance of the persons will be measured, by using clinical evaluation~     tests and questionnaires. On the second day they will be tests on the dual tasks, specific a~     comparison between single versus simultaneously performed tasks.~   "
82036|NCT02493153|"~     The investigators are very pleased to register the study entitled A prospective study for~     the effect of cholecystectomy to the liver in consideration of hepatic steatosis 3months~     after cholecystectomy with Ultrasound.~      This study deals with prospective ultrasound study about hepatic steatosis development 3~     months after cholecystectomy. This study was approved by the Institutional Review Board of~     the local institute. From Oct, 2013 to Jul, 2014, assessment of liver changes after~     cholecystectomy was carried out in 82 patients with gallbladder disease. In conclusion, the~     investigators thought that cholecystectomy might be considered as a risk factor for hepatic~     steatosis.~   "
82037|NCT02493140|"~     The purpose of this study is to assess the efficacy and safety of a cashew apple extract on~     weight management and associated metabolic risk factors in overweight/obese volunteers,~     versus placebo, after 12 weeks of treatment.~   "
82061|NCT02492828|"~     This will be a retrospective cohort study using national register linkage data (including~     prescription, inpatient, mortality, and socioeconomic data). The study period will be from~     May 29, 2013 to June 30, 2015. Patients will be followed from the start of treatment (index~     date) until their death, exiting the database, or until the end of the study period (June 30,~     2015).~   "
82038|NCT02493127|"~     Objectives:~      To determine the association between priming and measurements of hand function such as grip~     strength~      Primary null hypothesis:~      There is no difference in grip strength (best of three attempts) as a percent of the opposite~     hand between patients that complete the standard Pain Catastrophizing Scale (PCS) compared to~     patients that complete the positively adjusted PCS.~      Secondary null hypotheses:~      There is no difference in grip strength (last of three attempts) as a percent of the opposite~     hand between patients that complete the standard PCS compared to patients that complete the~     positively adjusted PCS.~      There is no difference in grip strength (best of three attempts) before and after completing~     the questionnaires between patients that complete the standard PCS compared to patients that~     complete the positively adjusted PCS.~   "
82039|NCT02493114|"~     This trial investigates the impact of curative lung cancer treatment on functional status and~     exercise tolerance. Furthermore this trial investigates possible underlying causes and~     consequences of deconditioning.~   "
82040|NCT02493101|"~     The purpose of this study is to determine the location of periostin and urine periostin level~     in patients with lupus nephritis and IgA nephropathy.~   "
82041|NCT02493088|"~     The prediction of dangerousness remains a delicate subject, relevant in current psychiatry.~     Scalable psychopathological elements identified in schizophrenia and mood disorders are~     considered as most at risk for crime committing. The French High Authority of Health (HAS)~     recommends to identify and prevent risk situations of violence and to develop research at~     this level. Some authors have worked on criminal career and became interested in risk factors~     for aberrant driving behaviors but also in environmental or clinical elements accompanying~     these phases. To our knowledge, no specific study about contextual elements before misconduct~     and which could lead to aberrant driving behaviors among individuals diagnosed with~     antisocial personality disorder has been described to date The investigators propose to~     follow individuals diagnosed with antisocial personality disorder in prison during 6 months~     in order to list their conduct disorders and contextual elements upstream of these~     misconducts. The investigators will also study the effect of contextual factors related to~     judicial steps on the appearance of aberrant driving behaviors.~   "
82042|NCT02493075|"~     The objective of the study is:Phase I: To validate or otherwise determine the~     Chinese-specific appropriate contact force during PVI in PAF.Phase II: To evaluate the~     effectiveness and safety of ablation guided by the appropriate contact force.~   "
82043|NCT02493062|"~     This study is to review how the uterus heals after having open fetal surgery. Open fetal~     surgery causes a scar perhaps two: one from the open fetal surgery and a second from delivery~     by cesarean section; rarely, the same area of your uterus was used for both open fetal~     surgery and delivery. From other studies of surgery performed on a uterus, some of the~     uterine scars do not heal well. This study's intervention uses sterile saline to spread open~     the inside of the uterus. The saline is slowly injected into the uterus using a catheter. An~     ultrasound is performed to take pictures of the uterus, its inside and the walls of the~     uterus. In this way, the healed areas from the uterine surgery can be seen with ultrasound~     and evaluated. This is performed at least 6 months after delivery.~      Primary Outcome:~      Measure the depth of the scar and location of the scar 6 months or longer after delivery.~   "
82044|NCT02493049|"~     The first major objective of this pilot trial is to demonstrate that it is possible to study~     myelin repair in relapsing-remitting multiple sclerosis (RRMS) patients with enhancing~     lesions on MRI by using advanced imaging techniques. To demonstrate that this is possible the~     investigators will recruit 24 RRMS patients who are being treated with standard disease~     modifying therapy (DMT) and have new lesions identified on clinically indicated brain MRI~     scans and measure myelin repair at 16 and 32 weeks using MRI measures of myelin repair. The~     second major objective is to determine how much repair occurs in participants treated with~     domperidone compared with those who are not treated. This will allow us to design larger~     trials to confirm that domperidone improves repair. The study will also confirm the safety~     and tolerability of domperidone in RRMS, determine circulating prolactin levels during dosing~     with domperidone 10mg three times daily in people with RRMS, and explore the impact of other~     clinical factors (such as age) on lesion repair.~      In addition, blood will be collected to test for metabolomics and the investigators will bank~     blood for future study of biomarkers that can help the investigators better understand MS.~     Metabolomics is an experimental test where changes in the pattern of the chemicals in blood~     cells are compared at different time points (during and after inflammation). There will be~     random changes but changes that are common in most study participants may help identify~     chemicals that signal stages in injury or repair. The investigators will also compare the~     pattern of change in those with the best repair to those with the worst repair. This may help~     identify a chemical that is associated with better or worse repair and help develop new~     treatment strategies. There are currently no blood tests that help in the diagnosis of MS,~     help determine which drug a person will respond to, or help determine a person's expected MS~     outcome. Any such tests would be considered biomarkers.~   "
82045|NCT02493036|"~     A Single-Dose, Open-Label, Extension Study to Evaluate the Sustainability of the Effects of~     SYN-010 in Patients with Irritable Bowel Syndrome with Constipation~   "
82046|NCT02493023|"~     Bronchoscopic diagnosis and staging of lung cancer must be gentle and quick, and requires~     optimal sampling precision.Electromagnetic navigation systems are promising for~     intraoperative guiding based on maps made of preoperative CT images. Navigation accuracy~     depends largely on correct alignment of preoperative images to the patient´s position in~     space during endoscopy. In this study, the accuracy of a new fast and automatic~     image-to-patient registration method during the initial phase of bronchoscopy is assessed in~     patients referred for lung cancer investigation.~   "
82047|NCT02493010|"~     The primary objective of the study is to examine the safety, usability and preliminary~     efficacy of a novel arousal-based biofeedback system in alleviating social anxiety. The~     investigators hypothesize that after 4 weeks of hour-long interventions, participants will~     show reductions pre- and post-intervention in their Liebowitz Social Anxiety Scale scores.~   "
82048|NCT02492997|"~     The octipolar applicator is intended for circumference reduction treatment by reduction of~     adipose size and enhancement of collagen synthesis as the result thermal and non-thermal~     collagen stimulation. This trial is intended to evaluate the effect of radio frequency (RF)~     and pulsed electromagnetic fields (PMF) treatment on circumference reduction.~   "
82049|NCT02492984|"~     An open-label, single-arm, post- authorization pragmatic clinical trial on the safety and~     efficacy of Xyntha (Moroctocog-alfa (AF-CC), Recombinant FVIII) in subjects with hemophilia A~     in usual care settings in China for approximately 6 months or or approximately 50 exposure~     days whichever occurs first~   "
82062|NCT02492815|"~     Observational study to evaluate the effectiveness and safety of ipilimumab, administered~     during the European expanded access programme (EAP) in pretreated patients with advanced~     (unresectable or metastatic) melanoma.~   "
82063|NCT02492802|"~     Posaconazole plasma concentration and inflammatory markers will be determined in all samples~     available from routine analysis.~   "
82050|NCT02492971|"~     Appropriate assistive devices are important factors for the activity participation of the~     disabled. These devices should be prescribed by the specialists based on their functional~     needs. However, most individuals in need of assistive devices locate in the household,~     school, or nursing institute, in which the professional interventions are not always~     available on demand. Consequently most assistive devices are used without thorough~     evaluation, therefore do not necessarily meet the exact needs of the individual. Hence an~     easy-to-access and easy-to-use assistive technology device indexing system based on the~     functional needs of the subjects is necessary. The goals of this two-year study are twofold:~     assistive technology indexing system application(APP) development and promotion. First, the~     multidisciplinary research team, composed of specialists from assistive technology,~     rehabilitation, computer science, and special education fields, is going to integrate and~     refine the current resources and develop an assistive technology indexing system App based on~     the functional needs of the disabled. Second, in cooperation with the disabled community and~     special schools, the team is going to promote the use of the App and evaluate its usability~     via System Usability Scale. This App will be beneficial to the individuals in need of~     assistive device application. It can also be used as an assistive device manual for the~     specialists. The App will guide the individuals step by step to the proper assistive devices~     based on their functional capacities. The complete system will include details of each~     assistive device and link up with the related service resources. With its registering~     function, the statistics collected via user clicks can serve as references for further design~     adjustments and assistive device related policy modifications. All together this App can~     provide comprehensive services to the disabled in need of assistive devices.~   "
82051|NCT02492958|"~     The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of a~     single dose of Staphylococcus aureus 4 antigen vaccine in Japanese adults aged 20 to <86~     years.~   "
82052|NCT02492945|"~     This study is to assess the safety and effect of polydeoxyribonucleotide(PDRN) on the lateral~     epicondylitis with ultrasonography-guided injection of the PDRN or dextrose solution.~      Condition: lateral epicondylitis~      Intervention Drug: polydeoxyribonucleotide, PDRN Drug: dextrose solution, 15% as~     prolotherapy, active control~      Phase 4~      Study type: Interventional~      Study design: Treatment, Parallel Assignment, Double Blind((Subject, intervention performer,~     Investigator, Outcomes Assessor), Randomized, Safety/Efficacy Study~      Official Title: Safety and Effects of PDRN(polydeoxyribonucleotide) Injection in Patient with~     elbow epicondylitis in randomized double-blind active-control comparative study~      Estimated Enrollment: 40~   "
82053|NCT02492932|"~     Two approaches are possible when the first finder needle attempt of the internal jugular vein~     cannulation fails; the needle can be turned slightly laterally or the puncture point can be~     moved slightly medially. This study is an ultrasonographic stimulation study to evaluate the~     success rate of turning the needle laterally and moving the puncture point medially, and to~     determine the proper angle or distance for the second try of internal jugular vein~     cannulation.~   "
82054|NCT02492919|"~     There is a growing incidence of sepsis and septic shock in people after surgery, for which~     there may be several reasons: more elderly people and more severe illnesses are entering~     operating theatres, more invasive systems are being used to take care of patients in~     intensive care units, etc... Sepsis and septic shock are the most prevalent illnesses which~     cause the highest mortality in intensive care units.~      The incidence of this illness is 500,000 / year in the USA, and 240-400 / 100,000 persons in~     Europe. So this is a subject of great interest in hospitals and also to the National Health~     System (to both health workers and the health authorities) as a lot of money is spent on this~     illness.~      Since the 19th century, ultraviolet rays have been known to be able to sterilize~     microorganisms (to kill them); yet no ultraviolet system machine has been on the market,~     until now, to control nosocomial infections.~      The Medixair system, which aims to do this, has recently come on to the market. It uses~     C-ultraviolet rays, which are the strongest kind of ultraviolet rays to kill microorganisms.~      Thus, it is of interest to know whether this system is good enough to lower infections in~     intensive care units. It is logical to believe that the the fewer the micro-organisms, the~     lower the possibilities of infection.~   "
82055|NCT02492906|"~     Due to scarce published articles about this subject, the researchers aim to study the volume~     measurements of the brain cortex of patients with primary severe knee osteoarthrosis and~     those with chronic knee pain compared to healthy and non-symptomatic volunteers, correlating~     the neuroimaging of cerebral volumetry with pain intensity, pain duration, knee function and~     pressure pain threshold.~   "
82056|NCT02492893|"~     People with HIV and a substance use disorder who are reentering the community from prison or~     jail face the dual risks of relapse and interruptions in adherence to antiretroviral therapy~     (ART) medication. This mixed-methods randomized controlled trial will compare the stress,~     substance use and ART adherence outcomes of participants in a 12-session, 90-minute weekly~     yoga group intervention with participants in a treatment as usual control group. All~     participants are re-entering the community, have HIV and experience substance use challenges.~   "
82057|NCT02492880|"~     This is a prospective, on-label, multi-center, non-randomized, exploratory, single-arm study~     to characterize the effects of programming features of the Boston Scientific Precision~     Spectra™ Spinal Cord Stimulator (SCS) System using the CoverEdge™ surgical lead.~   "
82058|NCT02492867|"~     This is a pilot study to improve local tumor control while maintaining the same rate of~     treatment toxicity by adapting therapy to the uninvolved lung and esophagus while continuing~     to adapt therapy to the tumor for patients with Stage II/III NSCLC.~   "
82059|NCT02492854|"~     The objective of this study is to compare the effectiveness of standard moist dressings and~     PICO single-use negative pressure dressings in post-operative lower extremity bypass~     patients. This study will compare the dressings' ability to decrease swelling, decrease~     post-operative infection, and improve mobility and quality of life measures.~      Subjects will be asked to participate in this study because they will undergo a lower~     extremity bypass using the ipsilateral great saphenous vein. Subjects will then be randomized~     to two post-operative treatment groups. One group will receive standard sterile gauze and the~     other will receive PICO single-use negative pressure dressings. Both groups will be assessed~     for study measures in follow-up visits as clinically indicated up to 1 year with the 30 day~     timepoint as the primary outcome for study measures.~   "
82060|NCT02492841|"~     Background: Dental caries is considered an oral health problem worldwide. In Chile the last~     national epidemiological study (2007) showed a national prevalence of dental caries in~     children 6 years (70.3%) and 12 (62.5%). Direct pulp capping is a preventive dental therapy,~     keeps the vitality of the tooth using some inductive materials mineralized tissue formation.~      Objective: The main objective of this study is to evaluate the effectiveness of two~     innovative direct pulp capping materials; Biodentine compared MTA and calcium hydroxide in~     the maintenance of pulp vitality in teeth permanent molars.~   "
82066|NCT02492763|"~     This is a multicenter randomized, double-blind, placebo- and active-controlled (liraglutide;~     Victoza®), parallel-group, clinical trial of MK-8521 in participants with type 2 diabetes~     mellitus (T2DM) with inadequate glycemic control while on a stable dose of metformin (≥1000~     mg/day).~      The trial will include a 1-week screening period; at least an 8-week antihyperglycemic agent~     (AHA) washout period, if required; a 14-week blinded therapy period (which includes~     single-blind run-in and double-blind therapy); and a 14-day post-treatment visit, 2 weeks~     after the last dose of investigational product.~      The primary hypothesis of the trial is that MK-8521 provides greater reduction in hemoglobin~     A1C relative to placebo after 12 weeks of once-daily administration in participants with T2DM~     with inadequate glycemic control on metformin monotherapy.~   "
82067|NCT02492750|"~     This partially randomized phase I/II trial studies the side effects and best dose of anakinra~     when given together with lenalidomide and dexamethasone in treating patients with early stage~     multiple myeloma. Biological therapies, such as lenalidomide and anakinra, may stimulate or~     suppress the immune system in different ways and stop cancer cells from growing. Drugs used~     in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. It is not yet known whether lenalidomide and dexamethasone are more effective with~     or without anakinra in treating patients with multiple myeloma.~   "
82068|NCT02492737|"~     The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics,~     pharmacodynamics and clinical activity of AG-881 in advanced hematologic malignancies that~     harbor an IDH1 and/or IDH2 mutation~   "
82069|NCT02492724|"~     Patients are candidates for single-level Artificial Disc Replacement between C3 and C7 who~     suffer from cervical symptomatic degenerative disc disease. A maximum of 200 cases will be~     enrolled into the study. An 18-month recruitment period is planned with a 4-year~     postoperative follow-up period for each subject. Thus, it is anticipated that the study will~     require a minimum of 5.5 years. Patients will be assessed preoperatively, intraoperatively,~     prior to discharge and again at 6 weeks, 6 months, 1 year, 2 years and 4 years~     postoperatively from the date of surgery.~   "
82070|NCT02492711|"~     The purpose of this study is to determine whether patients treated with margetuximab plus~     chemotherapy have longer progression free survival and overall survival than patients treated~     with trastuzumab plus chemotherapy.~   "
82071|NCT02492698|"~     The objective was to evaluate the effect of the consumption of dual probiotic strains~     containing Lactobacillus curvatus (L. curvatus) HY7601 and Lactobacillus plantarum (L.~     plantarum) KY1032 on weight loss, body adiposity and inflammatory markers including~     lipoprotein-associated phospholipase A2 (Lp-PLA2) activity in overweight subjects.~   "
82072|NCT02492685|"~     The investigators' study is a prospective study to evaluate the enhancement pattern of~     contrast-enhanced endoscopic ultrasonography and suggest the criterions for differential~     diagnosis between gallbladder polyps by using software program of quantitative analysis.~   "
82073|NCT02492672|"~     The current registry is being undertaken to assess the long-term (12 month) safety and~     tolerability of Venofer in the pediatric population with chronic kidney disease that requires~     intravenous iron maintenance therapy.~   "
82074|NCT02492659|"~     Since femtosecond laser was approved for cataract surgery by FDA in 2010, femtosecond laser~     assisted cataract surgery (FLACS) has demonstrated high precision of capsulotomy, reduced~     phacoemulsification power and time, and comparable refractive outcome in clinic.~      It is still unknown whether there are toxic substances produced due to photochemical or~     high-energy physical effect of femtosecond laser during FLACS.~   "
82075|NCT02492646|"~     The purpose of this study is to evaluate the influence of none-lubricated dry tube on the~     incidence of Postoperative Sore Throat (POST) after general anesthesia with endotracheal~     intubation.~   "
82076|NCT02492633|"~     The primary objective of this project is to evaluate the effectiveness of an enhanced~     intervention vs. a standard intervention to complement a comprehensive smoke-free policy, in~     a multi-site, privately managed affordable housing context.~   "
82077|NCT02492620|"~     It is the investigators hypothesis that participants treated with Ferric Citrate (FC) during~     the non-dialysis CKD stage (4/5) with sufficient duration prior to initiating RRT, will~     result in improved biochemical control of anemia (Hb, TSAT) and mineral metabolism (P, FGF23)~     and furthermore, will result in a reduced need for ESA and intravenous iron. The~     investigators further hypothesize that effective treatment of anemia and mineral metabolism~     with FC in the pre-dialysis and transition period will result in improved physical~     functioning, reduced hospitalization and reduced total cost of care when compared to~     participants receiving contemporaneously provided standard of care therapy.~   "
82078|NCT02492607|"~     A substantial number of DCIS lesions will never form a health hazard, particularly if it~     concerns slow-growing low-grade DCIS. This implies that many women might be unnecessarily~     going through intensive treatment resulting in a decrease in quality of life and an increase~     in health care costs, without any survival benefit.~      The LORD (LOw Risk DCIS) study is a randomized, international, multicenter, phase III~     non-inferiority trial, and aims to determine whether screen-detected low-grade DCIS can~     safely be managed by an active surveillance strategy or that the conventional treatment,~     being either WLE alone, WLE + RT, or mastectomy, and possibly HT, should remain the standard~     of care.~   "
82079|NCT02492594|"~     Invasive fungal infections (IFI) in immunocompromised patients pose a major challenge for~     diagnostics designed to permit timely onset of appropriate treatment. The aim of the current~     clinical-diagnostic studies, one in in pediatric and one in adult patients at high risk of~     IFI, is to test newly developed diagnostic approaches to invasive fungal infections in~     relation to established procedures. The studies will be performed in a prospective, blinded~     fashion, and represent a work package within the FUNGITECT grant supported by the European~     Commission. The studies will focus on analyses of blood-samples from patients with febrile~     neutropenia during treatment of acute leukemia or after hematopoietic stem cell~     transplantation.~   "
82080|NCT02492581|"~     USE-PACT is a cohort study of patients initiating Selincro® with one-year follow-up,~     performed using a random sample of prescribers. The aim of the study is to evaluate the use~     of Selincro in real-life and its impact on alcohol consumption at one year.~   "
82081|NCT02492568|"~     To evaluate the increase in Overall Response Rate (ORR) in the pembrolizumab alone arm~     compared to the pembrolizumab after SBRT arm at 12 weeks~   "
82082|NCT02492555|"~     The purpose of this study is to determine if the IBD patient doing home monitoring by web~     app's for disease activity (DA) and fecal calprotectin (FC) on demand (OD), compared with~     patients doing home monitoring scheduled interval combined with on demand(SI+OD) ( every~     3.month).~      Will home monitoring of DA and FC OD vs SI+OD reduce frequency of relapse in one year follow~     up? Is the frequent FC measurement in SI+OD test group predictive of an early recognition of~     relapse, and thus help change the naturel course of disease? Will home monitoring of DA and~     FC in OD vs SI+OD change the course of the disease in terms of disease activity, spread of~     the disease, hospitalizations and number of hospitalization days, required surgery and~     outpatient visits? Is there a difference in patients' compliance with treatment plan between~     OD vs SI+OD ? Is there difference in patients-adherence between OD vs SI+OD ?~   "
82083|NCT02492542|"~     The purpose of this study is to investigate the effect of electric stimulation on the pelvic~     floor function in cervical cancer patients with type III hysterectomy.~   "
82084|NCT02492529|"~     Unrandomized, unblinded, monocentric comparative Functional Magnetic Resonance Imaging study.~   "
82085|NCT02492516|"~     Amyotrophic lateral sclerosis (ALS) is a lethal degenerative disorder that upper motor and~     lower motor neurons are destroyed in brain stem and spinal cord. Riluzole is the only~     therapeutic option now. Recently several studies have shown that stem cell transplantation is~     safe and can be effective in reduction of disease progression and increase of quality of~     life.~   "
82086|NCT02492503|"~     Experience with substituting carboplatin for cisplatin is limited in advanced and recurrent~     cervix cancer and there has been no counterpart to GOG 158, which documented therapeutic~     equivalency of cisplatin/paclitaxel and carboplatin/paclitaxel for treatment of ovarian~     cancer, performed in a cervix cancer population.~   "
82087|NCT02492490|"~     The objective of this trial is to determine if autologous Stromal Vascular Fraction (SVF)~     derived Mesenchymal Stem Cell (MSC) infusion during and after kidney transplantation from~     Donation after Citizen Death (DCD) can effectively reduce the need for post transplant~     immunosuppressant and elevate GFR of allograft. The investigators will infuse autologous SVF~     derived MSC to the recipients during and after operation to assess the effect of SVF derived~     MSC and closely monitor renal function, dosage of immunosuppressant, acute rejection, and~     graft survival. 120 patients eligible for the study as described below will be enrolled, with~     60 patients in intervention group and 60 in control group.~   "
82088|NCT02492477|"~     The benefits and risks of flushing or not flushing the non-used PORT-A-CATH® in cancer~     patients and the time interval of eventual PORT-A-CATH® flushing are currently unknown. The~     manufacturers of PORT-A-CATH® recommend regular flushings every 4 weeks. In clinical~     practice, the intervals are usually at least three months. Regular flushing might lead to a~     decreased risk of PORT-A-CATH® thrombosis, but may also lead to an increased infection or~     thrombosis rate and patients discomfort. Therefore, this study investigates the safety of not~     flushing the PORT-A-CATH® for 6 or 12 months.~   "
82089|NCT02492464|"~     This will be a double-blind randomized clinical trial carried out on subjects with suboptimal~     control of LDL-cholesterolemia, following a Mediterranean diet, and treated with a red yeast~     rice extract (containing 10 mg monacolin K per daily dose) or placebo, in order to evaluate~     the middle-term effects on vascular health evaluated by non invasive methods (Vicorder(R)~     apparatus)~   "
82090|NCT02492451|"~     The investigators will try to assess the effect of endometrial injury preceding the~     intrauterine insemination cycle on the pregnancy rates compared to cycles with luteal phase~     support and the control group.~   "
82091|NCT02492438|"~     To assess the immunogenicity of the PCV13 (13 valent pneumococcal conjugated vaccine) vaccine~     as compared to the PPV23 (23 valent pneumococcal polysaccharide vaccine) vaccine in patients~     treated with chronic hemodialysis that are pre-immunized with the PPSV23 vaccine or are PPV23~     vaccine naïve by measuring the ELISA and OPA (opsonophagocytic assay) titers after 4 and 52~     weeks.~   "
82092|NCT02492425|"~     The purpose of this study is to evaluate the disease burden of hospitalized patients with CAP~     and HCAP in real life of China~   "
82093|NCT02492412|"~     The purpose of this study is to evaluate the efficacy and safety of HE10 eye drop for the~     patients with moderate to severe dry eye syndrome.~   "
82094|NCT02492399|"~     The purpose of this study is to determine whether the application of the extended myoectomy~     in patients with obstruction of the left ventricular output more efficient than standard~     myoectomy by Morrow.~   "
82095|NCT02492386|"~     In this prospective, unblinded, single-arm, single-center study, investigators would like to~     assess the feasibility and safety of the bioabsorbable everolimus-eluting stents in patients~     with erectile dysfunction and concomitant internal pudendal artery stenoses. A total of 15~     bioabsorbable vascular scaffolds (BVSs) are planned to be assessed and will be deployed in~     the internal pudendal artery, with a 1:1 ratio of both proximal and distal segments.~   "
82096|NCT02492373|"~     To investigate the benefit of the application of topical high potency steroid on the~     incidence of post inflammatory hyperpigmentation after laser treatment.~   "
82097|NCT02492360|"~     This study targets patients with cisplatin-induced peripheral neuropathy and will allow us~     to: a) study peripheral neuropathy in diverse human sensory neurons in ways that were not~     possible previously; b) gain insight on druggable targets to treat or prevent this~     devastating side effect of chemotherapy; c) provide a human cellular model that can be used~     for screening of drugs to determine if they are neurotoxic. The combination of patient~     information and in vitro measurements provides a highly relevant and clinically useful model~     for studies aimed to impact treatment selection for the individual cancer patient.~   "
82107|NCT02492230|"~     The objective of Left atrial appendage closure compared to standard antiplatelet therapy in~     patients with AF who underwent percutaneous coronary intervention (LLA-PCI) study is to~     evaluate the safety and efficacy of implantation of left atrial appendage closure compared to~     standard antiplatelet therapy for prevention of thromboembolic events and stent thrombosis in~     subjects with AF who underwent PCI.~   "
82108|NCT02492217|"~     To identify new candidate genes and proteins that are differentially expressed in responders'~     vs non-responders to anti-TNF alpha therapy at the several time points the investigators will~     use the transcriptomic and proteomic analyses. Demonstrate a link between gene expression and~     protein markers regarding prediction to anti-TNF alpha therapy efficacy.~   "
82098|NCT02492347|"~     Selective Serotonin Reuptake Inhibitors (SSRIs) are a group of antidepressants that suppress~     the re-absorption of a chemical called Serotonin in the brain, and improve mood. SSRI use in~     the treatment of mental health problems has increased greatly since their introduction in the~     1980's. When given in pregnancy they cause less fetal effects than other antidepressants.~     However they are still known to cause premature birth, heart defects and withdrawal symptoms~     in the baby. Withdrawal symptoms can occur in up to 30% of exposed babies, where as heart~     defects have been found to increase by 2-3 times against the normal rate of 1%. There is very~     limited information available, but it is also thought it may cause lengthening of a certain~     portion of the heart beat, the QT interval, which has been shown to lead to sudden death in~     adults. The QT interval will be looked at in this study, comparing babies exposed to SSRIs in~     pregnancy with unexposed babies.~      The study will be based in the United Kingdom (UK), at the Maternity Unit of a District~     General Hospital, and will be carried out over 12-18 months.~      A group of babies whose mothers took SSRIs whilst pregnant will have an Electrocardiogram~     (ECG) done when they are 2-3 days old. These will be compared with babies whose mothers did~     not, but whose babies were still in hospital because they were at risk of having an~     infection, but were found to be healthy.~      The study hopes to see whether there is a link between SSRI use in pregnancy and lengthening~     of the QT interval and if so, extra surveillance may be considered for this group of babies.~   "
82099|NCT02492334|"~     The study will test the efficacy of doxazosin, a long-acting and selective alpha-1 adrenergic~     antagonist, as compared to placebo in reducing PTSD symptomatology and alcohol use severity.~   "
82100|NCT02492321|"~     This is a Phase III multi-center, double-masked, vehicle-controlled, randomized, parallel~     group study evaluating the efficacy, safety and tolerability of EBI-005 as compared to~     vehicle given as a topical ophthalmic solution in each eye to subjects with moderate to~     severe allergic conjunctivitis (AC) three times daily for 4 weeks.~      Approximately 250 subjects at approximately 8 centers in the US will be screened and enrolled~     into the study.~   "
82101|NCT02492308|"~     The objective of this trial is to determine if autologous SVF derived MSC can effectively~     reduce the need for post transplant immunosuppressant in living-relative kidney~     transplantation. 120 patients eligible for the study as described below will be enrolled,~     with 60 patients in intervention group and 60 in control group.~   "
82102|NCT02492295|"~     Migraine headache is a frequent Emergency Department complaint. While first-line Emergency~     Department treatment for this condition is well-established, optimal second-line treatment~     options are not well-defined. First line Emergency Department treatments include~     Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), dopamine antagonists. Second line treatments~     that have been proposed include triptans, steroids, antiepileptics, benzodiazepines,~     magnesium and narcotics, but none have shown reliable Emergency Department efficacy (less~     than 50% in most studies). In the past ten years there have been several case series~     published on using low, sub-anesthetic doses of propofol for the treatment of refractory~     migraine. These case series have reported very impressive efficacy rates, especially in~     comparison to the published efficacy rates of other second-line treatments. Personal~     experience using this treatment modality has also yielded impressive clinical results. Most~     of the published series, however, have not been conducted in the Emergency Department.~      The Investigators propose to conduct a prospective, observational trial of low-dose propofol~     for the treatment of refractory migraine in the Emergency Department. Propofol is a~     frequently-used Emergency Department sedative, with a good safety profile when administered~     by experienced Emergency Medicine practitioners using appropriate monitoring. The primary~     outcome measurement will be reduction of pain after treatment, with secondary outcome~     measures related to the safety of treatment and continuation of pain relief after leaving the~     Emergency Department. Although the protocol will involve the use of low-dose propofol with~     the aim of achieving light-to-moderate sedation only, all patients will care for and monitor~     at a level appropriate for deep procedural sedation.~   "
82103|NCT02492282|"~     Closed loop system in intravenous anesthesia is more effective to maintain depth of~     anesthesia compared with manual system open, it is unclear what driver and variables to~     achieve this goal be more physiological; in the literature doesn´t exist studies showing that~     the closed-loop system for both hypnotic and opioid is better than the controlled~     pharmacokinetic models and open loop system (target controlled infusion-TCI) to maintain~     anesthetic depth. In addition, the infusion of the opioid lacks physiological controllers in~     closed loop. Thus, a system was designed for intravenous anesthesia in closed loop for~     propofol as hypnotic based on neuromonitoring bispectral index as anesthetic depth, and was~     integrated an additional closed system for remifentanil using hemodynamic variables and~     control algorithm associated with bispectral index.~      The purpose of this study is to determine the therapeutic effectiveness of a new system of~     administration of intravenous anesthesia in closed loop to maintain a depth of anesthesia~     compared to an open loop system TCI.~   "
82104|NCT02492269|"~     The overall goal of this project is to determine the role of anesthetic management in~     children undergoing cardiac surgery utilizing CPB in the setting of fast tracking and early~     extubation. An ideal anesthetic technique would ensure abolishing or diminishing stress~     response as would be evident by the stress markers levels and the level of two cerebral~     injury biomarkers (S 100 B and NSE). This should translate to better immediate postoperative~     outcome and hopefully improve both the short and the long term neurodevelopmental outcome in~     these children. The project is prospective, randomized and blinded study. The first and~     second aim of the study should be conducted over 2 year period. Our long term aim will be~     concluded when these children reach the school age.~   "
82105|NCT02492256|"~     Although circumferential pulmonary vein isolation (PVI) has been considered as the~     cornerstone for atrial fibrillation ablation, there has been a substantial recurrence rate.~     The investigators designed a prospectively randomized study to evaluate whether additional~     atrial ganglionated plexi ablation guided by the SUMO technology improves the clinical~     outcome in patients with persistent AF.~   "
82106|NCT02492243|"~     The trial will inform whether detection of ventricular arrhythmias by means of implantable~     loop recorder (ILR) can help to predict SCD in the large population of survivors of a~     myocardial infarction with preserved left ventricular function, EF>40%. This may improve risk~     stratification in these patients, and can inform on the clinical use of subcutaneous monitors~     to identify post-infarction populations in need for an intervention to prevent sudden death.~   "
82110|NCT02492191|"~     Introduction Day surgery is a well-established practice in many European countries, but only~     limited information is available regarding postoperative recovery at home though there is a~     current lack of a standard procedure regarding postoperative follow-up. Furthermore, there is~     also a need for improvement of modern technology in assessing patient related outcomes such~     as native software applications. This article describes the RAPP study protocol, a~     mixed-methods study to evaluate if a systematic e-assessment follow-up in patients undergoing~     day surgery is cost effective and improves postoperative recovery, health and quality of~     life.~      Methods and analysis This study is a mixed-methods study design that includes a multicenter,~     two-group, parallel, single-blind randomized controlled trial (RCT) and qualitative interview~     studies. One thousand patients >17 years of age who are undergoing day surgery will be~     randomly assigned to either e-assessed postoperative recovery follow-up daily in 14 days~     measured via smartphone app including the Swedish web-version of Quality of Recovery (SwQoR)~     or to standard care (i.e. no follow up). The primary aim is cost effectiveness. Secondary~     aims are improvements on postoperative recovery, health-related quality of life (QoL) and~     overall health; (b) to determine whether differences in health literacy have a substantial~     and distinct effect on postoperative recovery, health, and QoL; and (c) to describe day-care~     patient and staff experiences with a systematic e-assessment follow-up after day surgery.The~     primary will be measured at 2 weeks postoperatively and secondary outcomes b) at 1 and 2~     weeks and c) at 1 and 4 months.~   "
82111|NCT02492178|"~     The study aims at describing the pharmacokinetic properties of rectal artesunate in well~     characterized severely ill patients using intravenous artesunate as a comparator.~   "
82112|NCT02492165|"~     The purpose of this study is to describe the immunogenicity and safety of IMOJEV® in adult~     and pediatric populations in Vietnam and serve a bridging study to compare immunogenicity,~     reactogenicity, and safety data obtained with IMOJEV® in the Vietnamese population with data~     from other Asian pediatric populations.~      Primary objective:~      - To describe the safety profile of a single dose of IMOJEV®.~      Secondary objectives:~        -  To evaluate the immune response to JE 28 days after the administration of a single dose~          of IMOJEV® in healthy Vietnamese subjects aged from 9 months to 60 years.~   "
82113|NCT02492152|"~     The purpose of the study is to see whether the use of DIANATAL during active labor, reduces~     the rates of episiotomy and vaginal tears.~   "
82114|NCT02492139|"~     The overall purpose of this study is to evaluate the reliability and usability of the~     reusable BrownieForSymphony pump set in home use.~      The primary objectives of this study is to asses and compare the System Usability Scale (SUS)~     score of the BrownieForSymphony pump set and the current used Symphony pump set.~      Secondary Objectives~      The secondary objectives of this study are:~      to evaluate the rate of usability problems with the BrownieForSymphony pump set~        -  to evaluate the pragmatic quality (task/goal fulfilment) of the BrownieForSymphony pump~          set~        -  to evaluate perceived comfort during pumping with the BrownieForSymphony pump set~          Prospective Cohort Study (quasi Cross over design)~   "
82115|NCT02492126|"~     To determine whether contraction abnormalities in the esophagus plays a role in~     gastroesophageal reflux induced cough, and thus cough severity in patients with chronic~     cough.~   "
82116|NCT02492113|"~     The main purpose of this study is to define at the bedside the Titrated-PEEP level for~     obese patients that increases the likelihood of extubation and ventilator liberation.~      The investigators hypothesized that a titrated level of PEEP (Titrated-PEEP) during SBT~     will keep the lung recruited, maintain oxygenation, and decrease the work of breathing~     resulting in successful ventilator liberation. In addition, post-extubation the investigators~     hypothesize that these patients will require noninvasive ventilatory support in the form of~     CPAP at the level of titrated-PEEP used during the SBT.~   "
82117|NCT02492100|"~     This research study is evaluating the feasibility and impact of an intervention to improve~     sexual function in stem cell transplant survivors on participants' sexual function, quality~     of life, and mood.~      - It is expected that about 50 stem cell transplant survivors will take part in this research~     study.~   "
82118|NCT02492087|"~     The objective of this study is to investigate whether topical application of tranexamic acid~     into the uterine cavity and the surgical site intra-operatively can reduce blood loss and~     provide better surgical haemostasis in parturients with moderate to high risk for bleeding~     undergoing caesarean deliveries.~   "
82119|NCT02492074|"~     The study evaluates the gene-environment interaction of the COMT-genotype on the effects of~     the phytocannabinoids delta-9-tetrahydrocannabinol, cannabidiol or a combination of both on~     induction of psychotic symptoms, endocannabinoid levels in human body fluids, neuronal~     processing, and neural oscillations. In addition the effects of the phytocannabinoids on~     lipid levels in serum and cerebrospinal fluid, cognition, neuronal processing assessed by~     fMRI as well as D2-receptor availability assessed by [18F] desmethoxyfallypride.~   "
82120|NCT02492061|"~     This study aims at assessing the effect of a demand-creation intervention on couples' HIV~     counseling and testing (couples' HCT) uptake among married couples who have never tested~     together as a couple. The study is being implemented in 12 clusters; six intervention and six~     comparison clusters. A total of 1,538 couples will be enrolled into the study; 769 couples~     per arm. Couples in the intervention communities are invited to participate in small group,~     couple-focused or men-only, interactive sessions lasting 3-4 hours in which the advantages~     and fears associated with couples' HCT are discussed with invited couples to motivate them to~     consider testing together as a couple. The meetings are reinforced with testimonies from~     previously tested couples. At the end of the sessions, couples or men receive invitation~     coupons which they present to a designated health facility to receive couples' HCT services~     (couples are free to receive individual HCT or not to honor the invitation, if they are not~     interested in taking the HCT offer). In the comparison communities, standard of care health~     education activities including general adult community sessions are held but couples do not~     receive any invitations to test as a couple. Nevertheless, couples in the comparison~     communities have unlimited access to HIV counseling and testing services that are offered by~     the Rakai Health Sciences Program within the study communities. The investigators hypothesize~     that couples in the intervention arm will be more likely to test together than those in the~     comparison arm. The study objectives include: a) exploring the motivations for and barriers~     to couples' HCT uptake; b) assessing the effect of a demand-creation intervention on couples'~     HCT uptake among married couples with no prior couples' HCT experience, and c) exploring the~     effect of couples' HCT vs. individual HCT on linkage to and retention in HIV care.~   "
82121|NCT02492048|"~     This is multi-center prospective, longitudinal case series with comparison to historical~     controls.~   "
82140|NCT02491801|"~     The proposed study is planned to determine the potential role for regular fat dairy products~     in short-term metabolic control in younger and older adults and the metabolic flexibility in~     response to food components, which are areas that have not yet been explored. Subjects would~     be served with solid (cheese), semi-solid (yogurt) and liquid (milk) dairy products and skim~     milk (control) and water (non-caloric control) in three separate studies.~   "
82122|NCT02492035|"~     The Canadian hypertension education program recommends increased physical activity, adoption~     of the Dietary Approaches to Stop Hypertension (DASH) diet, and reduction in sodium and~     alcohol intake for treatment and prevention of hypertension. Objective: To describe patients~     participating in an interdisciplinary lifestyle intervention to reduce blood pressure in a~     family medicine primary care setting. Design: Descriptive study. Participants: The study aims~     to recruit 60 sedentary hypertensive patients to participate in a 6-month~     randomized-controlled trial. To be eligible, patients must be ≥18 years of age, sedentary~     (7-day measured steps/day and self-report), hypertensive (based on 24-h ambulatory blood~     pressure measurements [ABPM]), non-smoker, non-diabetic and without dyslipidemia.~     Intervention: Patients are recruited by health care professionals of the family medicine unit~     and are thereafter randomized to one of four intervention groups: 1) standard medical care~     (control), 2) improved diet (DASH diet), 3) physical activity, or 4) both improved diet and~     physical activity. Patients are evaluated (pre, mid and post intervention), monitored, and~     educated by the interdisciplinary health care team that includes a physician, a~     kinesiologist, a nutritionist and a nurse, depending on the intervention group. T-tests and~     descriptive statistics were used to analyse data. This study will document the efficacy of a~     primary care lifestyle intervention program on cardiometabolic and hypertension risk factors.~   "
82123|NCT02492022|"~     Quitting smoking is a big decision, a decision to achieve better health. Trying to quit~     smoking can be stressful. The prospect of dealing with withdrawal symptoms, fear or failure~     to change the routine, can also be sources of stress.~      Withdrawal from nicotine is characterized by symptoms that include anxiety, irritability,~     hunger and cravings for more tobacco. Nicotine creates a dependency so that the body develops~     a need for a certain level of nicotine at all times. Unless that level is maintained symptoms~     of withdrawal appear.~      For tobacco users trying to quit, symptoms of withdrawal from nicotine are unpleasant and~     stressful, but they are temporary.~      Research has demonstrated the relative effectiveness of pharmacotherapy treatments in smoking~     cessation but no studies have examined the effects of the probiotics on the withdrawal~     symptoms associated with the tobacco cessation during nicotine replacement therapy (NRT).~      The purpose of this study is to assess the effectiveness of two probiotic products during NRT~     for managing withdrawal symptoms associated with smoking cessation.~   "
82124|NCT02492009|"~     The proposed study is a pilot randomized controlled trial (RCT) of an electronic patient~     decision aid (PDA) for antidepressant use in pregnancy. The overall aim of this pilot RCT is~     to establish the feasibility of future large international RCT of the PDA's effectiveness.~   "
82125|NCT02491996|"~     The investigators proposed a desire satisfaction-targeted intervention for disordered~     gamblers (DTIG) due to the limitations of the abstinence-targeted intervention, which is~     based on the weak self-control relative to growing desire to gamble. This intervention model~     perceives loss of gambling control as a failure of strategy in which gambling is anticipated~     to fulfill various desires (i.e., desires for fame, money, and escapism). Therefore, the~     alternative behaviors to fulfill original desires directly become the main therapeutic~     purpose.~      Materials and Methods: Outpatients who were primarily diagnosed as gambling disorder by the~     DSM-V were treated by DTIG. This method usually comprised 1 or 2 sessions, 60 minutes in~     duration, delivered by a psychiatrist. Participants were examined : 1) Basic background such~     as gender, age,; 2) medical variables such as the onset age, the duration of the problem~     gambling, psychiatric complications, motivation to quit gambling; 3) assessment of severity~     (DSM-5, SOGS and G-SAS); 4) Short prognosis; 6 months-outcome after intervention (problem~     gambling/ control gambling/ abstinence).~   "
82126|NCT02491983|"~     This is an international, randomized, open-label, controlled, multicenter phase II clinical~     trial to investigate and compare the safety and efficacy of palbociclib combined with~     fulvestrant or letrozole in women with ER+, HER2- locally advanced or metastatic breast~     cancer.~   "
82127|NCT02491970|"~     The purpose of this study is to demonstrate superiority of Fluticasone/Formoterol~     (Flutiform®) to Fluticasone/salmeterol based on the small airway function by assessing the~     Impulse Oscillometic System (IOS) in uncontrolled asthma patients requiring ICS/LABA~     concomitant treatment.~   "
82128|NCT02491957|"~     The purpose of this study is to evaluate the safety and feasibility of LOFT Therapy in breast~     cancer survivors. In a previous study, the investigators found that many patients are more~     debilitated at diagnosis than previously recognized. Both chemotherapy and anti-estrogen~     therapy have a large effect. Within 6 months patients replace muscle with fat leading to a~     significant reduction in muscle power and endurance. Our data suggests that common exercise~     recommendations for at least 150 minutes of exercise a week would be far beyond many of our~     patients' physical ability after therapy, leading to the soreness, injury, frustration, and~     early discontinuation (or failure to initiate an exercise program in the first place). The~     degree of muscle loss seen in our patients is similar to that documented in US astronauts~     after long-term space flight. Our collaborator Dr. Yvonne Cagle, retired USAF flight surgeon,~     noted that the cosmonauts were in better shape (had less muscle atrophy) than the astronauts.~     This difference was more than could be explained by the rigorous Russian exercise program.~     The only key distinction was the compressive, penguin suits used by the Russians. This~     observation lead Dr. Cagle to develop a technique called low intensity, off~     loaded-compressive therapy (LOFT) to replicate the impact of the Russian penguin suits for~     patients who were debilitated, whether by space flight or by chronic conditions such as~     arthritis, Parkinson's disease, and multiple sclerosis. The LOFT method does not require~     excessive exertion or strain on the joints. In field observations, LOFT therapy improved~     muscle strength, muscle mass, endurance, sleep quality, and fatigue. This pilot study is the~     first to evaluate the safety, feasibility, and biologic impact of LOFT on breast cancer~     survivors.~   "
82141|NCT02491788|"~     The purpose of this study is to test the hypothesis that ingestion of the wake-inhibiting~     drug suvorexant 30 minutes prior to daytime sleep initiation in individuals working overnight~     shifts will significantly improve both objective (total sleep time, sleep efficiency, wake~     after sleep onset) and subjective (sleep quality) measures of daytime sleep.~   "
82142|NCT02491775|"~     The investigators propose to conduct a pilot feasibility study of single agent afatinib in~     patients with previously untreated metastatic EGFR (epidermal growth factor receptor) mutant~     adenocarcinoma of the lung (NSCLC = non-small cell lung cancer) with the sole purpose of~     characterizing the genomic landscape before afatinib and at the time of disease progression.~   "
82129|NCT02491944|"~     The Sponsor is developing the study drug, AZD9291, for the potential treatment of nonsmall~     cell lung cancer. Lung cancer has been the most common cancer in the world for several~     decades and represents 12.8% of all new cancer cases in 2008.~      The purpose of this study is to see how much AZD9291 is taken up by the body when dosed by~     mouth (tablet) compared to when the study drug is dosed once by injection directly into the~     vein (intravenously). The dose given directly into the vein will be radiolabelled. This means~     that the test drug has a radioactive component which helps us to track where the drug is in~     the body. This allows us to detect the differences between the tablet and the intravenous~     dose.~      The study will be performed in 12 healthy male subjects aged 18-65 years. On Day 1, subjects~     will be dosed with a single oral dose of 80 milligrams AZD9291 tablet followed by 100~     micrograms [14C] AZD9291 dosed as an intravenous microdose beginning 5 hours and 45 minutes~     after the oral dose has been administered. Subjects will remain in the study centre until~     after the 120 hour post-dose blood sample is obtained and will return to the clinic for~     further visits on Day 8, 10, 15 and 22 for pharmacokinetic and safety assessments.~   "
82130|NCT02491931|"~     Introduction: Glutamine (GLN) is the most abundant free amino acid in the body. It modulates~     immune cell function and is an important energy substrate for most cells (especially for~     enterocytes and lymphocytes) in critical patients. GLN levels significantly decreased during~     sepsis/critical illness leading to an increase in infectious complications, organ failure and~     mortality. Moreover, in cases of ischemia/reperfusion injury in the myocardium, GLN increases~     the levels of Adenosine triphosphate (ATP)/Adenosine diphosphate (ADP) ratio and prevents~     intracellular lactate accumulation. Recently, the perioperative effect of intravenous and~     oral GLN treatment been associated in lowering levels of cardiac injury markers such as~     Troponin-I (TROP-I) and the number of postoperative complications in patients who underwent~     Cardiopulmonary Bypass (CPB). The aim of the study was to analyze the oral dose of~     preoperative oral GLN treatment in patients who underwent CPB with extracorporeal circulation~     in Mexican patients.~   "
82131|NCT02491918|"~     This prospective, randomized, clinical trial looks to compare children undergoing congenital~     cataract surgery with intraocular lens (IOL) implantation in terms of visual axis obscuration~     as well as postoperative complications such as glaucoma, inflammation and IOL centration when~     IOL fixation is performed using two different techniques : 1) conventional in the bag IOL~     implantation with anterior vitrectomy, and, 2) posterior optic capture of the IOL through the~     posterior capsulorhexis without any vitrectomy. 61 eyes of 61 children randomized to~     receiving IOL implantation using one of the two techniques will be followed up until 12~     months postoperatively.~   "
82132|NCT02491905|"~     This study evaluates the safety and efficacy of HL tablet on reducing hepatic fat in~     non-alcoholic fatty liver disease patients. The patients are allocated to three groups; low~     dose, high dose, and placebo control group.~   "
82133|NCT02491892|"~     This study will evaluate the efficacy and safety of pertuzumab (rhuMAb 2C4) in participants~     with metastatic breast cancer which has progressed during or after standard chemotherapy and~     which is not amenable to curative therapy. Those who are maintaining a response to therapy or~     who have stable disease at the end of the formal study period will continue treatment until~     disease progression or unacceptable toxicity. Approximately 120 participants will be~     enrolled.~   "
82134|NCT02491879|"~     This study aimed to analyse the analgesic effect of ketoprofen gel in patients presented with~     mechanical low-back pain to the emergency department.~   "
82135|NCT02491866|"~     Objectives~        1. to develop and validate a Computerized Adaptative Testing (CAT) of self-perceived~          quality of care in Psychiatry.~        2. to analyze the implementation of this new measure in clinical practice : qualitative~          analysis of the relationship patient/professional.~   "
82136|NCT02491853|"~     This is a prospective observational multi-center multi-national study of the characteristics~     and outcomes of patients receiving implantable cardioverter-defibrillators (ICD) in the Arab~     Gulf region. A total of 1,500 patients will be enrolled. Data on baseline clinical~     characteristics, ICD programming parameters, inpatient outcomes, and clinical events such as~     mortality and ICD discharges over 1 year of follow-up will be collected.~   "
82137|NCT02491840|"~     Some subtypes of gastric and cardia tumors such as adenocarcinoma or gastric linitis with~     disseminated cells respond poorly to the pre-operative chemotherapy, and some of them do not~     respond to chemotherapy usually performed. Doing chemotherapy in these patients could delay~     their surgical management. The completion of chemotherapy for these patients would be a bad~     prognosis factor according to recent data from the literature. Therefore, the aim of this~     research is to find prognostic markers of sensitivity to chemotherapy usually performed. The~     investigators are going to use biopsies realized at diagnosis and select patients good and~     bad responders.~      Primary purpose:~      To study cardia and gastric tumors, molecular markers sensitivity to pre- and post- perative~     chemotherapy protocols (EOX protocol ... FOLFOX) or chemoradiation~      Secondary purposes:~        -  To assess the impact of patients' lifestyle (via a questionnaire) on the response to~          chemotherapy~        -  To study markers of cancer stem cells~        -  To correlate clinical and molecular markers with patient survival and quality of life~          questionnaires~        -  To characterize the expression levels (Met, Her2, FGFR2) and mutations (p53 ras) in~          frequently deregulated genes in gastric cancers.~        -  To characterize the level of expression of predictive candidate markers (ΔNp73, TAp73,~          HDAC4, mir140, EZH2, CXCL12, CXCR4, CXCR7) found in the literature.~        -  To correlate the abnormalities found in the with tumor stages (before and after~          chemotherapy) and with 5 years overall survival and progression-free patients~   "
82138|NCT02491827|"~     Purpose of the study is to answer the question whether confocal laser endomicroscopy (CLE,~     also named 'optical biopsy') might improve the results of medically necessary neurosurgery to~     prove practicability, safety and harmlessness of CLE during neurosurgical procedures~   "
82139|NCT02491814|"~     This study investigates the effects of commercially-available dairy (1% cow's milk and yogurt~     beverage) and non-dairy alternatives (almond and soy beverages) on satiety and post-meal~     blood glucose. Each participant will receive every treatment in this crossover design study.~   "
82143|NCT02491762|"~     This study evaluates the effect of breast reconstruction surgery on respiratory functions. 45~     patients elected for unilateral or bilateral breast reconstruction surgery will go through~     respiratory function examinations a month prior to the surgery, one month after surgery and~     three months after surgery.~   "
82144|NCT02491749|"~     Ultra-fast track anaesthesia (UFTA) aims at immediate extubation of cardiac surgical patients~     at the end of the operation. This study compares the effect of UFTA versus continued~     postoperative mechanical ventilation on the ICU length of stay (LOS).~      Methods. Fifty two elective adult patients were randomly allocated into UFTA and conventional~     groups by computer-generated random numbers. Redo operations, pre-operative intubation,~     uncontrolled diabetes, shock/LVEF <45%, PASP >55mmHg, creatinine clearance <50 ml min-1,~     haemodynamic instability, or those with concerns of postoperative bleeding were excluded.~     Pre- and intra-operative management was similar and Logistic EuroSCORE II was calculated for~     all. Intra-operatively, haemodynamic parameters, urine output, SPO2, arterial blood gas~     analysis (ABG), 5-lead ECG, operative- bypass- and cross clamp time, and opioid consumption~     were collected.~      Postoperatively, patients were compared during their ICU stay. Data were analysed by~     χ²/Fischer exact, unpaired student's t-test, univariate two-group repeated measures ANOVA~     with post hoc Dunnett's test, and Mann-Whitney U tests as appropriate. p<0.05 was considered~     significant.~   "
82145|NCT02491736|"~     The aim of this study is to analyse the effect of ketoprofen gel in children presented with~     ankle sprain to the emergency department.~   "
82146|NCT02491723|"~     It is acknowledged that IL-18, as a product of the inflammasome, is involved in host defence~     against viral and bacterial stimuli by modulating the immune response. The aim of this study~     was to determine IL-18 levels in serum of patients with Bronchiectasis and to investigate~     whether macrolide attenuate its levels.~   "
82147|NCT02491710|"~     Training is of great importance in laparoscopy. There are different commercially available~     trainers which are quite expensive and are used by trainees only inside the hospital.~      The aim of this study is to find out whether basic laparoscopic skills training using an~     inexpensive tablet-based laparoscopic box trainer leads to equal training results (=~     improvement of skills) compared to practicing with a conventional commercial box trainer.~     Furthermore, trainee satisfaction with this home-made alternative compared to the standard~     trainer will be assessed.~   "
82148|NCT02491697|"~     The prognosis of advanced breast cancer does not improve much recently although varies of~     adjuvant drugs have been tried.Dendritic cells co-cultured with cytokine-induced killer~     cells(DC-CIK) immunotherapy has been proved to improve survival in several cancers, but its~     role in advanced breast cancer stains unclear. The purpose of this study is to evaluate the~     efficacy and safety of DC-CIK immunotherapy combined with capecitabine versus capecitabine~     monotherapy for the treatment of advanced breast cancer.~   "
82149|NCT02491684|"~     A study to investigate if inhaled Interferon beta-1a is safe and tolerated, and can prevent~     or reduce the severity of asthma attacks when administered to asthma patients at the onset of~     symptoms of common cold or influenza~   "
82150|NCT02491671|"~     The effectiveness of tissue sealants to prevent Prolonged Air Leak (PAL) after lung resection~     procedures remains unproved. The investigators hypothesize that one of the main reasons for~     that is the heterogeneity of previously studied populations. Since currently the risk of~     postoperative PAL can be scored with a reasonable accuracy, the aim of this research is to~     investigate the effect of routine application of a novel tissue sealant in patients selected~     on the basis of a high risk of PAL estimated before surgery.~   "
82151|NCT02491658|"~     The purpose of this study is to investigate the safety and efficacy of umbilical cord derived~     mesenchymal stem cells (UC-MSCs) in patients with moderate to severe psoriasis vulgaris. Any~     adverse events related to UC-MSCs infusion will be monitored and the patients will be~     assessed by Psoriasis Activity and Severity Index (PASI) and Dermatology Life Quality Index~     (DLQI) in the baseline and after MSCs infusions.~   "
82152|NCT02491645|"~     Around 69-95% of children with Autistic Spectrum Disorder are known to have sensory~     processing abnormalities .Tackling these problems would help in better quality of life, both~     for the parents and the children. Sensory integration therapy, an individualized clinic based~     therapy have been shown to have a positive effect on those children with sensory~     abnormalities. Hence the investigators are doing this study , to primarily look into the~     efficacy and feasibility of home based sensory interventions in autistic children with~     sensory processing abnormalities.~   "
82153|NCT02491632|"~     The goal of this clinical research study is to learn about the effects of combining physical~     activity with dexamethasone to treat fatigue in patients with advanced cancer.~      This is an investigational study. Dexamethasone is FDA approved and commercially available~     for the treatment of tiredness, pain, and nausea. It is investigational to combine~     dexamethasone and exercise to treat fatigue in advanced cancer patients.~      The study doctor can explain how the study drug is designed to work.~      Up to 70 participants will be enrolled in this study. All will take part at MD Anderson.~   "
82154|NCT02491619|"~     The correlation between tooth inclination and bone thickness and the comparison between~     thickness measurements and buccolingual inclination before and after dental decompensation~     will be evaluated through tridimensional images in individuals with class III dentofacial~     deformities.~   "
82155|NCT02491606|"~     This study is a phase 2b, placebo controlled, randomized, blinded study of the efficacy of WR~     238605, a new primaquine analog, compared to placebo as chemosuppression of P. falciparum~     malaria in Nyanza Province, western Kenya.~   "
82156|NCT02491593|"~     The aim of this study is to compare the outcome of three (3) quantitative immunochemical~     faecal occult blood test in symptomatic patients.~   "
82157|NCT02491580|"~     Patients with previous malignancies have increasingly been accepted for renal~     transplantation. However, post-transplant malignancy risk and survival rates of these~     patients are unknown. Our aim was to assess if previous malignancies pose an unnecessarily~     high risk of post-transplant malignant tumours and if the organs as a resource are too~     limited for investment in this patient group.~   "
82171|NCT02491398|"~     This study is intended for Chronic Lymphocytic Leukemia patients who have already undergone a~     first or second treatment with drugs named bendamustine and rituximab. It will observe the~     results of this treatment and evaluate its efficacy and side effects.~   "
82172|NCT02491385|"~     The investigators try to find whether thoracic epidural analgesia (TEA) shortens the first~     gas-out time compared to iv-PCA and promotes earlier discharge after major upper abdominal~     surgery.~   "
82158|NCT02491567|"~     Hashimoto Thyroiditis (HT) and Graves Disease (GD) are known to be caused by abnormal immune~     response against self cells and tissues. Epigenetics is a novel field of biology studying the~     mechanisms by which the environment interacts with the genotype to produce a variety of~     phenotypes through modifications to chromatin that do not directly alter the DNA sequence. A~     very limited number of epigenetic studies have been published in patients with HT and GD so~     far. Therefore, the purpose of this study is to analyze DNA methylation status in White Blood~     Cells (WBCs) within the promoter regions of genomic sites that have been previously~     identified as susceptibility loci or sites for autoimmune thyroid disease, such as the CD40,~     FOXP3, CTLA4, PTPN22, CD25, and TPO genes.~   "
82159|NCT02491554|"~     This is a monocentric, randomized, controlled, 2 arms, interventional, observer-blinded~     feasibility trial.~      Patients suffering from essential tremor (ET) will be treated with Deep Brain Stimulation~     (DBS). For the implantation of the DBS electrodes and the DBS system (Activa INS, Medtronic)~     patients will randomized either to conventional stereotactic surgery of thalamic/subthalamic~     region with short anesthesia or to MR-tractography guided stereotactic surgery with target~     point of the dentato-rubro-thalamic bundle (DRT) in general anesthesia.~      Patients will visit the study center at screening, baseline/neurosurgery, six and twelve~     months after neurosurgery.~   "
82160|NCT02491541|"~     The purpose of this single-centre, randomized, double-blind, parallel control, phase 3 study~     is to evaluate the safety and immunogenicity of a rabies vaccine (Vero Cell) for human use in~     healthy Chinese subjects aged 10-60 years, according to the Essen methods (1-1-1-1-1)~     vaccination.~   "
82161|NCT02491528|"~     This is a multicenter, randomized, open, parallel group, active-controlled study. The study~     period is 25 to 26 weeks, including screening period of 1-2 weeks and treatment period of 24~     weeks.~   "
82162|NCT02491515|"~     In this study, the investigators would like to analyze the bone mineral density (BMD) , bone~     turnover makers, and fracture prevention effects of denosumab in Japanese patients under~     clinical practice. The participants are treated in the investigators hospital, who are under~     severe osteoporotic condition.~      The main objective of this study is to investigate effects of denosumab. The researchers also~     investigate the effects of Effects of previous osteoporotic therapy to denosumab treatment.~     In this study, the investigators analyse the determinants of subsequent BMD increase and~     fracture preventing effect by teriparatide.~   "
82163|NCT02491502|"~     This study evaluates the efficacy of the HIFU for the treatment of benign thyroid nodules~     with the FastScan version using assessment of patient experience and adverse event reporting.~   "
82164|NCT02491489|"~     Shoulder pain is one of the most common musculoskeletal conditions treated by physical~     therapists. One common treatment is passive glenohumeral joint accessory mobilization, which~     is the application of a therapist generated force to move the humeral head (ball) on the~     glenoid (socket) of the shoulder to improve motion and decrease pain. It is generally~     accepted that these mobilizations do not elicit active muscular contractions of the~     surrounding musculature. However, there is very little literature to support this assumption,~     and a preliminary PubMed search utilizing the terms shoulder, mobilization, and EMG~     returned zero relevant references. Therefore, the investigators plan to utilize surface~     electromyography (EMG), a non-invasive assessment tool, to objectively measure the activity~     of the rotator cuff muscles (the muscles that surround the shoulder and provide stability to~     the joint) during various grades(levels of force and amplitude of movement) of glenohumeral~     mobilization ( a standard of care treatment). It is also unknown if subjects pain levels~     impact the level of rotator cuff activity. To investigate these questions, the investigators~     will collect EMG data while performing mobilizations on a total of 20 subjects, divided into~     two groups: 10 pain free shoulders and 10 painful shoulders. Data analysis will then include~     descriptive analysis, estimates of effect size, and analysis for between group differences.~      The investigators hypothesize that there will be significant differences in muscular activity~     between groups related to the presence of shoulder pain.~   "
82165|NCT02491476|"~     The main objective of this study is to evaluate the feasibility of recording fast-ripples, a~     potential new biomarker of epilepsy, using the new micro-macroelectrodes developed by~     Dixi-Medical.~   "
82166|NCT02491463|"~     The purpose of this first time in human (FTiH) study is to assess the safety, reactogenicity~     and immunogenicity of 2 doses of the RSV investigational vaccine, when administered~     intramuscularly according to a 0, 1 month schedule, in healthy adults aged 18 to 45 years.~   "
82167|NCT02491450|"~     Comparative randomized, single dose, two-way crossover open-label study to determine the~     bioequivalence of Sofosbuvir from Heterosofir 400 mg F.C.T (Pharmed Healthcare Co., Egypt)~     versus Sovaldi 400 mg F.C.T (Gilead Sciences, Ireland) in Healthy Human Volunteers Under~     Fasting Condition.~   "
82168|NCT02491437|"~     The purpose of this randomized, two-arm and open label study is to demonstrate that the~     treatment of a daily dose of 3x10mg dydrogesterone orally is as effective and safe as the~     daily dose Crinone 8% intravaginal progesterone gel 90 mg for the luteal support in women who~     are unable to conceive a child and are undergoing IVF. The treatment will start on the day of~     oocyte retrieval and continue until pregnancy is negative or until week 12 gestation.~      Patients will be followed during treatment until 30 days after delivery to record any safety~     and tolerability data of the patient and their newborn (s).~   "
82169|NCT02491424|"~     Direct Skeletal Fixation of Prosthetic Limbs Following Trans-Femoral Amputation - Study of an~     Intraosseous Transcutaneous Amputation Prosthesis (ITAPTM).~   "
82170|NCT02491411|"~     This pilot trial studies how well dexamethasone and re-treatment with enzalutamide work in~     treating patients with prostate cancer that has spread to other places in the body~     (metastatic), does not respond to hormone therapy (hormone-resistant), and was previously~     treated with enzalutamide and docetaxel. Dexamethasone treatment may be able to reverse one~     resistance mechanism to enzalutamide therapy (overabundance of receptors for dexamethasone~     and other glucocorticoids inside cancer cells) and allow for renewed therapeutic sensitivity~     to enzalutamide. Androgens (a type of male hormone) can bind to androgen receptors found~     inside prostate cancer cells, which may cause the cancer cells to grow. Enzalutamide may stop~     the growth of prostate cancer cells by blocking the activity of the cancer cell androgen~     receptors. Giving dexamethasone prior to re-treatment with enzalutamide may be a treatment~     for prostate cancer.~   "
82173|NCT02491372|"~     This pilot research study aims to assess the effectiveness of an Acceptance and Commitment~     Therapy (ACT; Hayes Strosahl & Wilson, 2011) group based intervention at improving quality of~     life (QOL) and increasing Psychological Flexibility with survivors of Upper GI cancer~     following curative treatment. Participants will be invited to take part in an eight week~     intervention with outcomes being measured at baseline, midpoint, post-intervention and two~     month follow up. Outcomes will be compared with a randomised control group who will receive~     treatment as usual. Research has indicated that this population are under considerable~     psychological distress however within the UK there are currently no specifically tailored~     psychological interventions on offer to reduce this distress (Dempster, McCorry, Brennan,~     Donnelly, Murray & Johnston, 2012).~   "
82174|NCT02491359|"~     This pilot phase II trial studies how well carfilzomib works in treating patients with~     chronic graft-versus-host disease. Chronic graft-versus-host disease is a complication of a~     donor bone marrow or blood cell transplant, usually occurring more than three months after~     transplant, in which donor cells damage the host tissue. Carfilzomib may be an effective~     treatment for chronic graft-versus-host disease.~   "
82175|NCT02491346|"~     Poor glycemic control in critically ill patients can increase their mortality, while safe and~     efficient glucose control is laborious and time-consuming. The Space GlucoseControl which is~     installed with eMPC(enhanced Model Predictive Control) can get the blood glucose target range~     safely and effectively through regulating insulin dose rate. This study is a random~     controlled trial involving the patients with mechanical ventilation in intensive care unit in~     order to evaluate the difference of safety and efficacy of blood glucose control between SGC~     directed and conventional treatment. At last, the trial results can determine whether the~     Space GlucoseControl can control blood glucose safely and effectively in the patients with~     mechanical ventilation in intensive care units.~   "
82176|NCT02491333|"~     The objectives of this randomized controlled trial are to compare insulin sensitivity~     following true acupuncture + placebo metformin (Group 1) vs sham acupuncture + placebo~     metformin (Group 2) vs sham acupuncture + metformin (Group 3) in women with PCOS and IR.~   "
82177|NCT02491320|"~     This is a study protocol for a multicenter, randomized, and controlled trial. In this~     protocol, we present a randomized controlled trial comparing acupuncture pretreatment~     followed by letrozole vs letrozole alone in polycystic ovary syndrome (PCOS) women with~     anovulatory infertility. The high prevalence of insulin resistance (IR) in women with PCOS~     women is considered to be one of the major pathophysiological changes of PCOS, leading to~     anovulatiory infertility. A study has shown that electro-acupuncture could significantly~     improve insulin sensitivity. The effect of acupuncture pretreatment on anovulatory PCOS women~     followed by ovulation induction has not been investigated before. A total of 384 patients~     enrolled in this study will be randomized into one of two groups. The treatment group: a 16~     week acupuncture pretreatment followed by 4 cycles of letrozole and the control group: 4~     cycles of letrozole alone. The primary outcome is the live birth rate. We postulate that~     acupuncture pretreatment followed by letrozole results in a higher live birth rate when~     compared with letrozole alone.~   "
82178|NCT02491307|"~     This Study will evaluate the impact of a smartphone-based platform on a range of outcomes for~     medically-underserved patients with mood disorders (e.g. depression, anxiety, bipolar) cared~     for in a large statewide community health center. The primary goal of the Study is to reduce~     emergency room (ER) visits, hospitalizations, and to look at changes in service utilization~     by using the Ginger.io platform to enhance communication between behavioral health providers~     and their patients, increasing the early detection of exacerbations in mood disorders (e.g.~     depression, anxiety, bipolar) and proactive outreach. The secondary goal is to improve~     clinical & behavioral health outcomes.~   "
82179|NCT02491294|"~     Fuel for Fun: Cooking with Kids Plus Parents and Play (FFF), is an integrated research,~     extension, and education project targeting 4th grade students. Its long-term goal of reducing~     the risk of childhood obesity will be addressed by promoting healthful food and activity~     environments, policies and behaviors through: 1) building and testing the efficacy of a 4th~     grade comprehensive school- and family-based intervention, 2) applying it to an after-school~     setting to broaden its reach, and, 3) disseminating both versions through outreach.~   "
82180|NCT02491281|"~     This study is designed to evaluate the safety and tolerability of ascending single doses of~     LNA043 given intra-articularly into the human knee joint prior to its removal at total knee~     replacement surgery. In addition, this will help to establish the presence of LNA043 within~     the articular cartilage, assess pharmacokinetics and immunogenicity, and will allow~     exploration of biomarkers of hyaline cartilage repair.~   "
82181|NCT02491268|"~     Epidemiological, clinicopathological and animal studies show that vascular disease in various~     forms contributes to cognitive decline. Increasing age is the strongest risk for dementia~     irrespective of whether it results from a vascular etiology or neurodegenerative disease~     processes such as in Alzheimer's disease (AD). AD and vascular cognitive impairment, the two~     most common causes of dementia, represent two extremes of a spectrum of disorders; however, a~     number of entities, which possess varying degrees of neurodegenerative and vascular~     pathologies, occur in between. The pure forms of the disorders are preferred for convenience~     to label, treat or manage but conditions within the spectrum are the norm rather than the~     exception as dementia advances. Therefore, combinatorial therapy directed at both vascular~     and neurodegenerative aspects of dementia is a promising approach for the treatment of~     dementia in the elderly.~      Cilostazol acts as an antiplatelet agent and has other pleiotropic effects based on~     phosphodiesterase-3-dependent mechanisms. Increasing evidence suggests that cilostazol offers~     endothelial protection, via pleiotropic effects. Intriguingly, cilostazol has been shown to~     decrease amyloid beta (Abeta) accumulation and protect Abeta-induced cognitive deficits in an~     experimental model. In a pilot study of 10 patients with moderate AD (mean MMSE score, 11.9~     points) who received donepezil, cilostazol add-on treatment for 5-6 months demonstrated~     significantly increased MMSE score in comparison to baseline. Moreover, cilostazol was shown~     to be effective in preventing cognitive decline in patients with AD with cerebrovascular~     diseases, mild cognitive impairment (MCI), and mild dementia who received donepezil.~      These results highlight the need for a comprehensive prospective cohort study to analyze the~     effect of cilostazol on the preservation of cognitive function in patients with early-stage~     cognitive impairment, namely MCI.~   "
82182|NCT02491255|"~     The objective of this study is to confirm the safety and effectiveness of the Lotus™ Valve~     System in the Japanese medical environment for transcatheter aortic valve replacement (TAVR)~     in symptomatic subjects with calcific, severe native aortic stenosis who are considered at~     high or extreme risk for surgical valve replacement.~   "
82183|NCT02491242|"~     The objective of this study was to evaluate the efficacy and safety, and evolution of causes~     leading to change, of dual therapies based in Dolutegravir in patients requiring a change of~     virologically effective antiretroviral therapy.~   "
82184|NCT02491229|"~     The purpose of this study is to investigate whether a weight reduction with Hepafast in~     combination with raw food and vegetables for two weeks followed by a meal substitution with~     Hepafast and a calorie restriction in accordance with the Low Glycemic and Insulinemic Diet~     (LOGI) for 10 weeks is superior regarding improvement of non-alcoholic Fatty Liver Disease~     (NAFLD) compared to a conventional weight reduction in accordance with the LOGI diet without~     use of Hepafast for 12 weeks.~   "
82185|NCT02491216|"~     Acupressure has been used for thousands of years in China. Through applying pressure on the~     specific acupoints based on Traditional Chinese Medicine theory, acupressure could promote~     relaxation and wellness, balance yin-yang and treat diseases.~      The PI has been using acupressure to treat various diseases in the clinics of the School of~     Chinese Medicine, The University of Hong Kong. Acupressure has demonstrated significant~     efficacy in treating geriatric diseases, obstetric diseases, pediatric diseases, rheumatoid~     arthritis and various painful symptoms. When applying acupressure on the Head- Neck -~     Shoulder area, it could also help to improve insomnia, reduce pain, and regulate the mood of~     the patients.~      Frailty is a geriatric syndrome of growing importance in the medical field. Prevalence of~     frailty increases with age. As our life expectancy increase, there will be more elderly~     suffered from frailty in the later stage of their life. Although there is still a lack of~     universally accepted clinical definition for frailty, the syndrome is now commonly understood~     as decreased reserves in multiple systems, and lowered resilience to negative stress. Frailty~     could be initiated by single or multiple conditions including malnutrition, chronic diseases,~     lack of exercise, stress and physiological or social changes caused by aging. Its~     manifestation includes sarcopenia, anorexia, energy reduction, dysfunctional neuroendocrine~     system and a pro-inflammatory state. Frailty could affect the emotional state of the elderly,~     meanwhile, positive affect is protective against the functional and physical decline~     associated with frailty. There is limited treatment or medication for frailty. The~     investigators believe that acupressure could be a possible non invasive means to improve the~     general health conditions, including the emotional conditions of the frail elderly. In the~     past 2 years, the school of Chinese Medicine has been promoting acupressure as a health~     maintenance technique to the elderly, mostly frail elderly living in the community dwelling~     through seminars. It is in investigator's interest to run a prospective research to further~     understand the efficacy of acupressure in a wider range of frail elderly. The investigators~     would like to use a well-designed pragmatic randomized controlled trial (PRCT) to investigate~     if acupressure could help the frail elderly to improve their general quality of life~   "
82186|NCT02491203|"~     Stroke is a leading cause of death and long-term disability worldwide and its incidence is on~     the rise. Importantly, loss of arm function occurs in up to 85% of stroke survivors, with a~     significant long-term impact on activities of daily living, leisure activities and work. The~     capacity for recovery following a stroke depends on several factors, including the extent of~     the initial neurological damage, spontaneous recovery and rehabilitation, with possible~     recovery even years after the stroke. Unfortunately, accessibility of much needed~     rehabilitation services poststroke often remains limited, both in terms of intensity and~     duration, as reported in a recent report on post-stroke rehabilitation services in Quebec~     (Richard, 2013) Recent evidence suggests that homebased telerehabilitation (TR) is a viable~     approach for upper limb training post-stroke when rehabilitation services are not available.~     Similarly, the Canadian Best Practice Recommendations for Stroke Care update for 2013~     recommends home-based patient monitoring be used when frequent monitoring is needed and~     face-to-face visits are not available. Hence, The investigators have developed and propose to~     examine the use of a TR system that allows upper limb rehabilitation with ongoing off-line~     monitoring, to be used after usual poststroke rehabilitation is completed and services are no~     longer offered.~   "
82187|NCT02491190|"~     This project leverages digital health technology to support patient engagement and shared~     decision-making between families, patients, and providers. The investigators will start by~     finalizing the educational module and adding randomization for the trial (Aim 1). The~     investigators will then complete iterative user testing in the live system through~     measurement of educational module views and usability feedback interviews with 20 end users~     (Aim 2). The investigators will then conduct a randomized controlled trial to test the impact~     of the educational module on existing measures of patient engagement (Aim 3). The hypothesis~     is that parents who receive the educational module will have higher scores on shared~     decision-making, patient activation and overall patient experience.~   "
82188|NCT02491177|"~     This is a 2x2 factorial cluster randomized trial of two interventions to improve retention~     and adherence for women and infants on Option B+. The overall goal is to determine which~     intervention (or combination of interventions) maximizes antiretroviral therapy (ART)~     adherence and retention in care in the context of Option B+ and thus improves maternal and~     infant health outcomes.The proposed study will be conducted in rural Nyanza Province, Kenya~     at 20 low-resource primary health care facilities and associated communities supported by~     Family AIDS Care and Education Services (FACES), a President's Emergency Plan for AIDS Relief~     (PEPFAR)-funded HIV prevention care, and treatment program, ((AIDS) acquired immune~     deficiency syndrome, (HIV) human immunodeficiency virus) . The investigators will assess both~     process and outcome indicators using a 2x2 factorial design, in which equal numbers of~     clusters will be randomized to one of the interventions (community-based mentor mothers or~     theory-based mobile text messages), both interventions, or standard of care. The~     interventions will be added to fully integrated high quality HIV and antenatal, maternal,~     neonatal, and child health (ANC/MNCH) services already offered at these sites.~   "
82189|NCT02491164|"~     Critically ill patients are often ventilated in dedicated critical care units to provide~     respiratory support. Despite best practice patients can often develop a condition called~     adult respiratory distress syndrome (ARDS), which is characterised by deterioration in their~     respiratory function, and changes on chest x-ray. The correct management for ARDS is~     identifying the underlying condition causing the deterioration and identifying appropriate~     targeted therapy. One such cause is pneumonia, caused by a bacterial infection in the lungs~     of a ventilated patient. The patients may have been ventilated due to pneumonia but they may~     also develop pneumonia whilst ventilated. Ventilator associated pneumonia (VAP) has~     significant mortality.~      Despite all the clinical and laboratory data at the investigators' disposal there remains~     great difficulty in the accurate diagnosis of pneumonia and therefore treatment is often~     given empirically. Therefore, there is an urgent clinical need for accurate methods to~     diagnose the presence of bacteria deep in the lung in ventilated critically ill patients. As~     such, the investigating team have developed and synthesised an imaging agent called BAC TWO.~     BAC TWO will be instilled directly into the lungs of 12 patients to assess whether it can~     label gram-negative bacteria in the human lung.~   "
82190|NCT02491151|"~     Fluconazole is the first-line agent in the treatment of invasive candidiasis. Studies showed~     inappropriate drug exposure causes high mortality in critically ill patients. Under-dosing~     and ineffective fluconazole trough serum concentrations were found in a recent retrospective~     study. Variability in fluconazole exposure can be easily measured with therapeutic drug~     monitoring. For patient groups who are at risk for drug underexposure, therapeutic drug~     monitoring can be valuable regards decreasing mortality.~   "
82191|NCT02491138|"~     This study evaluates the efficacy of appearance-based interventions in promoting healthy~     sleep. One group of participants will receive standard information about sleep (control~     group), while the other group will receive information about how sleep affects their physical~     appearance (intervention group).~   "
82192|NCT02491125|"~     The study will investigate the effect of cereal based prebiotic fibres on intestinal health~     and functioning and host metabolism.~   "
82193|NCT02491099|"~     Primary Objective: To assess the activity of Afatinib in patients with persistent or~     recurrent uterine serous carcinoma overexpressing HER2/neu with the frequency of patients who~     survive progression-free for at least 6 months after initiating therapy. Secondary~     Objectives: To assess objective response rate and durable disease control rate. To assess~     overall survival. To assess the safety profile of Afatinib in uterine serous carcinoma~     patients.~   "
82194|NCT02491086|"~     Background About half of the daily smokers in Hong Kong have never tried and have no~     intention to quit smoking. 37.9% of daily smokers attempted to quit but failed. Nicotine~     replacement therapy (NRT) is a safe and effective pharmacotherapy to reduce withdrawal~     symptoms during early stage of tobacco abstinence and increase quit rate. However, the~     prevalence of using NRT in Hong Kong is lower than most of the developed countries. The~     proposed project aims to test if providing free NRT sampling to smokers can increase quit~     attempt and hence quit successfully.~      Methods Nurses and university undergraduate students will be trained, and will invite smokers~     at outdoor public places to participate in the randomized controlled trial, which randomized~     eligible smokers to intervention or control group. The intervention group will be provided~     with 1-week free NRT sampling and medication counselling, whereas the control group will only~     be advised to purchase NRT on their own. The primary outcome is the proportion of any~     self-reported quit attempt (no smoking for at least 24 hours) in the past month at 1- and~     3-month telephone follow-up.~      Discussions The findings will inform the feasibility and effectiveness of delivering free NRT~     sampling to increase quit attempt and abstinence. It will yield more information on smokers'~     adherence to the NRT sampling, side effect and safety issue of the usage. Moreover, it will~     guide a future larger trial to test the effect from the NRT sampling and translation to~     practice.~   "
82195|NCT02491073|"~     The purpose of this research study is to determine if the blood tests used to measure free~     thyroid hormone levels are affected by a drug called eslicarbazepine acetate. To determine if~     eslicarbazepine acetate interferes with these blood tests, blood samples will be analysed so~     that researchers can compare different types of lab tests that measure these thyroid~     hormones. Half of the people who participate in this study will already be taking~     eslicarbazepine acetate either as a study drug or as a prescription (Part 1) and the other~     half will be people who do not take eslicarbazepine acetate (Part 2).~   "
82196|NCT02491060|"~     The primary objective of this study is to compare the efficacy, safety and tolerability of~     IDP-121 Lotion and vehicle in the treatment of subjects with acne vulgaris.~   "
82197|NCT02491047|"~     This is a prospective, multi-national, multicenter, randomized, two arms, single blind,~     Standard of Care (SOC) controlled, with blinded central reading center study. This study will~     assess the safety and performance of BonyPid-1000™ in severe open tibial fractures (Gustilo~     IIIA and IIIB) when implanted as adjunct to SOC and compared to SOC alone.~   "
82198|NCT02491034|"~     The purpose of this project is to implement a Depression Education Intervention (DEI)~     designed to increase disease literacy, and dispel myths about depression and its treatment~     among Hispanic patients thus reducing stigma and increasing treatment engagement. This~     project will be conducted at one community health center whose patient population is majority~     Hispanic.~   "
82199|NCT02491021|"~     Admission to an intensive care unit (ICU) due to illness has been shown to have a dramatic~     effect on the human body and mind. Following discharge from an ICU, patients suffer from~     varying degrees of weakness and muscle wasting. It can take many months before their strength~     returns to something like before they were ill. This weakness can have important consequences~     on an individual, affecting their ability to perform routine tasks (e.g. housework,~     shopping), and whether they can return to work or not. Not surprisingly, this inability to~     perform activities they used to do prior to their illness can have knock on effects on their~     mental well being and confidence.~      What the investigators hope to see through this study is whether or not patients can recover~     their ability to perform exercise more quickly following an ICU admission if they undergo an~     exercise-based rehabilitation programme. The investigators also hope to see whether taking~     part in a rehabilitation programme has any affect on physical and mental well being.~      The investigators hope to use a simple exercise test on a bicycle to assess subjects ability~     to exercise shortly after leaving hospital. We will then repeat the test after a period of~     physiotherapy lead rehabilitation to see if they have received any benefit from the~     programme. The investigators hope to show that by undergoing an exercise-based rehabilitation~     programme subjects will recover their ability to exercise more quickly than those who do not.~      By means of questionnaires the investigators hope to see what effect the rehabilitation~     programme has had on participants physical and mental well being.~   "
82200|NCT02491008|"~     Thyroid hormone is a key regulatory hormone for a range of physiological systems, including~     the skeleton. Previous studies have suggested that subclinical thyroid dysfunction (SCTD) may~     be associated with deleterious skeletal effects. However, controversy persists on the~     clinical relevance of SCTD as well as on optimal thresholds for treatment. Available data~     have substantial limitations: 1) limited prospective data are available to assess the~     associations between SCTD and non-cardiovascular outcomes, such as fractures 2) lack of data~     from large RCTs to investigate the pathophysiological mechanisms of associations between~     thyroid hormone and bone loss. The aim of the study is to examine the relationship between~     subclinical hypothyroidism and thyroid hormone replacement in regard to skeletal fragility,~     bone mineral density (BMD), bone loss and metabolism, and the risk of fractures in elderly~     participants. The listed parameters will be assessed by dual energy X ray absorptiometry~     (DXA) and novel bone imaging techniques at baseline, at 1 year of follow-up. The study will~     be nested in the TRUST trial (clinicaltrials.gov ID: NCT01660126), and will make use of its~     study infrastructure to determine bone biomarkers from biospecimens at baseline, and at 1~     year of follow-up from 145 Swiss participants with persistent subclinical hypothyroidism~     randomized to either thyroxine or placebo in Bern and Lausanne.~   "
82201|NCT02490995|"~     The purpose of the study is to measure the interest of a movie explaining the path of the~     children in surgery, in order to reduce the anxiety of the children and his parents.~      This study is interventional, method randomized, controled, open-label, comparing two~     parallel arms: anesthesist explanations versus anesthesist explanations + a movie~     explanation.~   "
82202|NCT02490982|"~     The main goal of this investigator-initiated study is to evaluate the effectiveness and~     efficacy of Teriflunomide in a population of Relapsing Remitting Multiple Sclerosis (RRMS)~     patients treated in regular practice, over a period of at least two years, in the regular~     setting of a Multiple Sclerosis Clinic.~   "
82203|NCT02490969|"~     Registry of an interventional Study-proved Strategy (BIC-8) using Copeptin and Troponin for~     the Early Rule-Out of Acute Myocardial Infarction (AMI) in Patients with Suspected Acute~     Coronary Syndrome (ACS) and a low-to intermediate risk profile.~   "
82204|NCT02490956|"~     The purpose of this study is to evaluate diagnostic immunization protocol of rabies vaccine~     for diagnosis the patients with primary immunodeficiency disorders and study humoral and~     cellular immune response to rabies vaccine in patients with primary immunodeficiency.~   "
82205|NCT02490943|"~     Peginterferon-beta-1a (PEG) is an approved treatment for relapsing forms of MS that may cause~     injection related erythema. This is a randomized controlled cross-over trial of superficial~     hot and cold modalities to reduce injection site erythema caused by PEG.~   "
82206|NCT02490930|"~     A recent prospective multicenter study by Dr. Grossman demonstrated that 40% of patients with~     high grade glioma undergoing radiation and chemotherapy developed severe and persistent~     lymphopenia (CD4 counts <200 cells/mm3). This lymphopenia lasted for twelve months following~     radiation treatment and on multivariate analysis was associated with shorter survival. Our~     group has data that strongly suggests that this lymphopenia is secondary to the inadvertent~     radiation of circulating lymphocytes as they pass through the radiation beam. Investigators~     propose the use of FDA approved for multiple sclerosis, fingolimod to signal lymphocytes to~     leave the circulation prior to the initiation of radiation. It is a functional antagonist of~     the sphingosine-1-phosphate receptor (S1PR) pathway and prevents lymphocyte egress from~     secondary lymphoid organs.~      Oral fingolimod will be given 1 week prior to the initiation of concurrent radiation and~     temozolomide and will be discontinued immediately upon completion of the six weeks of~     therapy. The primary objective is to evaluate if fingolimod can be safely combined with~     radiation and temozolomide. Secondary endpoint is total lymphocyte counts (TLC) for the~     proposed study participants. Investigators expect that patients receiving radiation and~     temozolomide plus fingolimod have a recovery of lymphocyte counts to 80% of baseline within~     four months, reference to historical control in which sustained lymphopenia lasted for twelve~     months.~   "
82207|NCT02490917|"~     The main objective is to compare the efficacy of AMS800 ™ and ACT ™ devices for the Treatment~     of Female Stress Urinary Incontinence due to Intrinsic Sphincter Deficiency on social~     continence at 6 months.~      Continence is defined by the average number of pads used per day. The social continence is~     defined by (0-1) pad per day~   "
82208|NCT02490904|"~     Assess the impact of eplerenone (initiated within 2 hours prior to patient departure to the~     operating room and administered for 4 days during the post-operative period) on graft~     function evaluated by the measurement of glomerular filtration rate at 3 months - variable~     strongly associated with long-term graft survival.~   "
82209|NCT02490891|"~     The aim of the study is to measure tumoral angiogenesis modifications by RGD-K5 PET/CT before~     and after 2 cycles of chemotherapy in patients with lymphoma and a large tumoral mass~   "
82210|NCT02490878|"~     This randomized phase II study aims to investigate whether the addition of bevacizumab to~     standard corticosteroid therapy results in greater improvement in symptoms and less~     treatment-induced symptoms compared with standard corticosteroid therapy for patients with~     symptomatic brain radionecrosis following radiosurgery. It is hypothesized that the addition~     of bevacizumab to standard care corticosteroids will reduce treatment-induced toxicities and~     improve neurologic impairments in patients with brain radionecrosis following radiosurgery~     for brain metastases.~   "
82211|NCT02490865|"~     The study aims to determine the effects of nebulized RNS60 on selected biomarkers in the~     circulation.~   "
82212|NCT02490852|"~     This is a growth study of full-term infants. The growth of infants fed the investigational~     formula will be compared with infants fed a control formula. A breastfeeding arm will be used~     as reference.~   "
82213|NCT02490839|"~     Up to now, there is few randomized, large scale study prospectively and simultaneously~     comparing the efficacy, adverse effects and patient adherence of high-dose dual therapy~     (HDDT) and bismuth-containing quadruple therapy (BQT) as rescue regimens for H. pylori~     eradication.~      The aims of this study are:~        1. to compare the efficacy of HDDT, and BQT as rescue regimen in H. pylori eradication;~        2. to compare the patient adherence and adverse effects of these treatment regimens;~        3. to investigate factors that may influence H. pylori eradication by these treatment~          regimens.~   "
82214|NCT02490826|"~     The primary aim of this study is to develop software as a tool in speech and language therapy~     for the treatment of children (Portuguese and English) with phonologically based Speech Sound~     Disorders (SSD). Further, this project aims to test the effectiveness of this approach with~     two groups of preschool and school aged children with phonologically based SSD, with one~     group consisting of European Portuguese (EP) speakers and one group of British English (BE)~     speakers. Performance across the two groups will be compared. The total duration of the~     project will be 30 month.~   "
82215|NCT02490813|"~     Recently, there has been an increasing interest in using traditional Chinese medicine for~     food allergy. The Harvard group has successfully demonstrated the Food Allergy Herbal Formula~     - FAHF2 completely blocked peanut-induced anaphylaxis in a murine model, and currently being~     studied in human. Therefore, in collaboration with the Institute of Chinese Medicine, CUHK,~     the investigators have developed a more simplified Chinese herbal formula - X (CHFX),~     containing four food-grade Chinese herbs, Wu-mei (Fructus Pruni Mume); Ling-zhi (Gonoderma);~     Huang-bai (Cortex Phellodendron) and Zhi-su (Perilla frutescens).~      In the present study, the investigators would like to examine whether there is reduction in~     allergic symptoms in food challenge after administering the CHFX for 8 weeks. There will be~     pre- and post- CHFX food challenges and other related tests.~   "
82217|NCT02490787|"~     This trial is conducted globally. The aim of this trial is to investigate safety,~     pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the~     effect of the investigated drug on the body) of concizumab administered subcutaneously to~     haemophilia A subjects.~   "
82218|NCT02490774|"~     Investigation of pharmacological effects, drug blood levels and safety of an intrauterine~     system releasing the study drug BAY1007626 in comparison to Mirena and Jaydess in healthy~     young women treated for 90 days to determine the drug dose for further development~   "
82219|NCT02490761|"~     Unintentional weight loss and undernutrition are well described problems in elderly~     inpatients, occurring in around 23% to 62% of hospitalised elderly in developed countries.~     Not only are a large number of elderly patients undernourished at admission but a substantial~     proportion will lose weight and become malnourished during their hospital stay, putting them~     at increased risk of morbidity, mortality, poor clinical outcomes and prolonged length of~     hospital stay. However, as it is frequently impossible to correct undernutrition prior to~     hospital admission, every effort should be made to prevent weight loss and correct~     undernutrition during hospitalization. Therefore, screening and identification of predictors~     of patients at risk of weight loss and undernutrition at admission, and identification of~     modifiable factors (e.g. eating preferences and poor food hospital intake), where~     intervention might be helpful, are important aspects in the management of these patients.~      Before designing a food intervention study, there is a need to, firstly:~        1. describe hospital food intake, eating habits and preferences in elderly inpatients~          during hospitalization~        2. describe predictors of hospital food intake in elderly during hospitalisation~        3. compare energy and protein intake in elderly inpatients during hospitalisation with the~          United Kingdom Dietary Reference Values (DRVs)~      This study is a hospital based observational study. Eligible participants will be 125~     patients (aged ≥ 65 years old) admitted to the geriatric wards of 2 hospitals in the West of~     Scotland. Eligible participants will be seen 96 hours after admission in order to explain the~     study process and to obtain written consent. The researcher will record basic body size~     measurements and will ask the patient questions about living conditions, feelings, memory,~     health, eating habits, opinions about the hospital food service. Nursing staff will be asked~     about patient's functional activity. The researcher will also take pictures of a subset of~     patients' main meals (breakfast, lunch and dinner) on a single day, prior to and after~     eating. The researcher will meet each patient three times in total. The first time 4 days~     after admission; a second time, during the hospital stay and, finally, around the time of~     discharge to repeat some measurements including weight, BMI, skinfold, mid upper arm~     circumference, grip strength and calf circumference.~   "
82220|NCT02490748|"~     The purpose of this study is to determine whether combining of radiofrequency ablation (RFA)~     and cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with~     cervical cancer.~   "
82221|NCT02490735|"~     Chemotherapy is the main treatment method for patients with Esophageal Cancer. However,~     Relapse remains the major cause of treatment failure.Biological therapies such as CIK~     stimulate the immune system and stop tumor cells from growing. A series of studies reported~     that cytokine-induced killer cells (CIK) have a broad anti-tumor spectrum. The investigators~     suppose that CIK will improve the prognosis. Combining chemotherapy with biological therapy~     may kill more tumor cells. In this study, the patients will be treated with CIK cells after~     chemotherapy. The purpose of this study is to evaluate the efficacy of CIK for Esophageal~     Cancer.~   "
82222|NCT02490722|"~     The aim of this study is to investigate effects of interdisciplinary group based patient~     education in patients with low back pain.~      The patients will be recruited to four group based patient education lessons during a two~     months period. The study is a randomized controlled trial and the patients will be randomized~     to standard treatment or standard treatment and patient education. The patient education will~     be led by physiotherapists, nurses and physicians. The outcomes are functions, pain, quality~     of life, self-efficacy, and depression. The data are reported in questionnaires.~   "
82223|NCT02490709|"~     The purpose of this study is evaluation of the safety and the efficacy of transanal local~     excision in patients with cT3 rectal cancer which was downstaged into ycT0-1 after~     neoadjuvant chemoradiotherapy.~   "
82224|NCT02490696|"~     The purpose of the study is to compare the intratumoral biodistribution of FAZA and F-miso in~     patients with non-small cell lung cancer and correlate the results of PET scans with~     immunohistochemistry.~   "
82225|NCT02490683|"~     This study will test the effect of both Luna Rich X© and Reliv Now© against placebo pills or~     powder (control) on blood lipids. It will also explore the potential effects of these dietary~     supplements on inflammation markers and other biological and anthropometric measures. The~     study intervention will be 30 weeks in length. Twenty four subjects with 2 or more~     cardiometabolic risk factors will be randomized to participate in the study.~   "
82226|NCT02490670|"~     The purpose of this study is to compare two different preparations of an antibiotic called~     cephalexin to determine if they are essentially the same. The study has two periods.~     Participants will receive one preparation of cephalexin in each period. At least 7 hours will~     pass between the study periods. The study is expected to last about 2 days for each~     participant, not including screening or follow-up.~   "
82227|NCT02490657|"~     The inhaled Iloprost, approved for pulmonary hypertension, caused increase in oxygenation,~     and increase exercise tolerance in ARDS or chronic obstructive pulmonary disease. Inhaled~     iloprost has been researched in animal study, but not yet in human during one-lung~     ventilation. The investigators will enroll patients who diagnosed moderate to severe chronic~     obstructive pulmonary disease, preoperative pulse oximetry (SpO2) of below 95% at room air or~     PaO2 /FiO2 ratio< 150 mmHg after initiating one-lung ventilation. The primary outcome is~     pulmonary oxygenation expressed by PaO2 /FiO2 ratio. And secondary outcome is assessment of~     cardiac function including Tei-index during nebulizing iloprost. The investigators~     hypothesized inhaled iloprost will improve oxygenation and decrease the FiO2 in chronic~     obstructive pulmonary disease during one-lung ventilation.~   "
82228|NCT02490644|"~     One of the most important factor that affects the post op complication of the cardiac surgery~     is systemic inflammation. Valvular heart surgery requires cardiopulmonary bypass and~     cardioplegic arrest, which can arouse the ischemic/reperfusion injury causing myocardial~     damage and inflammatory response. These myocardial damage and inflammatory response can cause~     multi-organ failure or even death.~   "
82255|NCT02490293|"~     During the laparoscopic cholecystectomy for acute cholecystitis, most surgeons routinely use~     the postoperative antibiotics after surgery. However, there is no consensus regarding the~     actual need of postoperative antibiotics in these cases and the use of postoperative~     antibiotics remains controversial.~      Investigators will compare the surgical outcomes after laparoscopic cholecystectomy to the~     patients who has no evidence of systemic infection, according to the usage of postoperative~     antibiotics or not. The investigators expect that the routine use of postoperative~     antibiotics after laparoscopic cholecystectomy for acute cholecystitis gallbladder will have~     no effects on the postoperative morbidity.~   "
82229|NCT02490631|"~     Surgical site infection (SSI) following spinal surgery is a frequent complication and results~     in higher morbidity, mortality and healthcare costs. SSI following adult spinal surgery is a~     frequent complication that has been reported to occur in 0.7-12.0% of patients and result in~     higher postoperative morbidity, mortality and health care costs. Vanderbilt University~     Medical Center SSI rate is 7%. Treatment for SSI can be challenging often requiring revision~     surgery, long-term antibiotics, and prolonged hospitalization. The accurate identification of~     risk factors is thus important in the development of strategies to prevent these potentially~     devastating infections. This study proposes a randomized, controlled trial of neuro-spine~     patients of 2% chlorhexidine gluconate skin preparation cloths for the prevention of post op~     surgical site infections in spine patients.~      Use of CHG cloths the night before and morning of surgery (neckline to toes) will affect~     (decrease rates) of SSI compared to patients who receive routine standard of care (soap and~     water pre-op, day of surgery and daily post-operative).~   "
82230|NCT02490618|"~     The aim of this study is to determine the efficacy of the usage of a probiobitc lozenge in~     patients with residual bleeding pockets of ≥ 5mm 3 months following scaling and rootplaning.~     Simultaneously the additional benefit of subgingival application of probiotics via oil drops~     will be investigated.~   "
82231|NCT02490605|"~     The possible relationship between posture and instability of the masticatory muscles related~     to occlusion thus becomes the reason, the objective of this study. In this way, it will be~     possible to evaluate both postural alignment and postural balance in patients with signs and~     symptoms of temporomandibular joint disorder before and after the use of an occlusal plate.~     Our research will take place at the School of Odontology of the University of São Paulo in~     the clinics of the Occlusion and TMJ Services (SOA) and of the Envelhecer Sorrindo program,~     and the data will be collected in the Biophysics Laboratory of the School of Physical~     Education and Sports of the University of São Paulo. The population studies will be made up~     of 120 patients, 60 being part of the sample and the other 60 in the control group. All the~     patients in this study are over 20 years of age and are of both genders; the research~     criteria will be diagnosed by way of filling out the questionnaire of the RDC-TMD and~     complemented by way of diagnostic imaging via MRI of the temporomandibular joint. The study~     will be a clinical, randomized, controlled, prospective study and intervention. After the~     subjects' alignment is evaluated by way of photographs and their postural balance by way of a~     force platform, the group will the randomized; the sample group will receive an occlusal~     plate with criteria for occlusal stability (simultaneous, bilateral contacts with an absence~     of interference in the canine and anterior guides). The occlusal plate will be made from~     Vacuum Form acetate with a thickness of 1.5 mm; the simultaneous, bilateral, occlusal~     contacts and the canine and anterior guides will be obtained by way of autopolymerizable,~     acrylic resin with the mandible in a centric relationship. The occlusal plate will be~     controlled weekly. The control group will only receive orientation to do physiotherapeutic~     exercises seeking to correctly position the mandible in the resting position (maxillar teeth~     should be approximately 2 mm away from the mandibular teeth) while the tip of the tongue is~     positioned and accommodated on the roof of the mouth over the incisive papilla on the hard~     palate (without touching the teeth). The exercise will consist of repeatedly opening the~     mouth with the tongue cleaving to the roof of the mouth, 3 times per day, each period~     consisting of 3 sets with 15 repetitions. After 3 months, the two groups will be re-evaluated~     in terms of postural alignment and balance.~   "
82232|NCT02490592|"~     Compare the remineralizing effect of acidulated fluoride gel Flugel (1.23% FFA, DFL) and~     acidulated Fluoride Foam Flúor Care (1.23% FFA, FGM) in maxillary anterior permanent teeth of~     58 children aged 7 to 12 years of age.~      to verified the activity (visual scores) and the dimensional changes of whit spot lesions~     (with WHO probe and millimeter ruler), risk for caries (CAMBRA) and OHI-S (Simplified Oral~     Hygiene Index) of children.~   "
82233|NCT02490579|"~     The primary purpose of this study is to assess the responses of pregnant women and their~     social network to six videos about health in pregnancy. Our goal is to assess a)~     acceptability and b) understanding of core messages about healthy eating, exercise and weight~     gain during pregnancy. We will also assess c) non-clinical sources of health information~     during pregnancy.~   "
82234|NCT02490566|"~     Using technology alongside a pediatric chronic disease specialist and behavior specialist,~     the investigators are planning to help care for and coordinate the healthcare of children~     with chronic diseases, particularly childhood obesity, diabetes and asthma in Miami's most~     vulnerable communities. The University of (UM) Miller School of Medicine (MSOM) Pediatrics~     and TeleHealth departments propose to leverage information and communications technologies~     (ICT) in an innovative approach to improve the quality, access and efficiency of pediatric~     services for children and their families.~   "
82235|NCT02490553|"~     The ELISABET STUDY is across sectional Survey on a representative sample of two urban area~     conduct on a representative sample. The main objective of the project is to compare the~     prevalence of the obstructive ventilatory disorders (OVD) in the Urban Community of Dunkirk~     touched by the industrial pollution in relation to the one recovered in the Urban Community~     of Lille (CUDL) less industrialized.~   "
82236|NCT02490540|"~     There is accumulating evidence that inappropriate analgesia is asssociated with increasing~     risk of perioperative complications. The aim of the study is to compare intraoperative~     analgesia guided according to different methods of intraoperative analgesia monitoring, ANI~     and SPI respectively.~   "
82237|NCT02490527|"~     The purpose of this study is to gain insight into the side-effects of statin consumption, and~     assess the ability of epicatechin (a compound in dark chocolate) to counteract or reverse~     these changes. The investigators' prior research has shown that epicatechin can improve~     skeletal muscle structure and mitochondrial (which gives us energy) structure.~   "
82238|NCT02490514|"~     This open-label, non-randomized, retrospective-prospective, non-interventional study will~     evaluate the efficacy and safety of Mircera in patients with stage III-IV chronic kidney~     disease (CKD) not on dialysis. Patients will receive open-label treatment with Mircera for 12~     months at a dose to be determined by the investigator.~   "
82239|NCT02490501|"~     This is an open, randomized, rehabilitation-controlled study in subjects with complete~     Traumatic Spinal Cord Injury, where the active treatment consists of a surgical implantation~     of SC0806 (a biodegradable device with heparin-activated FGF1 and nerve implants).~   "
82240|NCT02490488|"~     The objective is to evaluate the efficacy and safety of masitinib in combination with~     gemcitabine in refractory ovarian cancer patients.~   "
82241|NCT02490475|"~     This study will evaluate the safety, tolerability, and pharmacokinetics of the combination of~     rhuMab 2C4 (Perjeta) and docetaxel (Taxotere) in participants with advanced solid tumors that~     have progressed during or after standard therapy, or for which no standard therapy is~     available. Participants will be enrolled and evaluated for dose-limiting toxicities (DLTs) in~     escalating-dose cohorts in order to determine the maximum tolerated dose (MTD).~   "
82278|NCT02489994|"~     Clinical Study to Evaluate the Performance of the ePrime System for the Treatment of~     Cellulite.~   "
82279|NCT02489981|"~     The safety of Spiriva® 2.5 µg Respimat® 60 puffs (hereinafter referred to as Spiriva®~     Respimat®) in patients with severe persistent asthma under the real-world use was not~     confirmed in clinical trials.~   "
82242|NCT02490462|"~     The Physical Therapy for children with Cerebral Palsy is of great complexity, in addition to~     improving the neuromotor components at the level of structure and body function, must empower~     them to carry out their activities and daily tasks and enable their social participation. In~     this way, the goals of Physical Therapy are related to promote the independence and~     functionality of the individual in situations of daily life. The participation of caregivers~     in the rehabilitation process can contribute to potentiate the gains obtained by physical~     therapy as well as to which they are incorporated into the day to day management of children~     with cerebral palsy. Objective: To assess whether Physical Therapy associated with the~     education of caregivers is effective in improving the functioning and quality of life of~     children with cerebral palsy. Hypothesis: The combination of Physical therapy with the~     education of caregivers improves in 15% the parameters analyzed against only 10% in those who~     are only Physical Therapy. Methods: 60 children with cerebral palsy after acceptance and~     signature in the term of informed consent will be randomly divided into 2 groups (G1:~     Physiotherapy and education of caregivers and G2: only Physical Therapy) to do 3 sessions of~     Physical Therapy and 1 weekly session of group education with duration of 45 min during 12~     consecutive weeks. The evaluation will be carried out by means of the System of~     Classification of Motor Function Gross (GMFCS), the evaluation of Motor Function through the~     scale GMFM-88 (Gross Motor Function Measure - 88 ) and the Activity and Participation will be~     evaluated by the Inventory of Evaluation of Pediatric Disability (PEDI). The analysis of the~     results will be carried out using the Statistical Package for the Social Sciences (SPSS)~     using descriptive statistics for social and demographic characteristics and inferential for~     normality of data (test Kolmogorov-Smirnov ), mean comparison test to check for differences~     between the groups and measures of association through the coefficient of correlation. The~     level of significance of 5% will be established~   "
82243|NCT02490449|"~     This study aim is to compare the efficacy of Dexlansoprazole MR intake before and after~     breakfast in patients with nonerosive reflux disease.~   "
82244|NCT02490436|"~     The purpose of this study is to determine whether the EGFR-inhibitor cetuximab is better than~     placebo for the treatment of neuropathic pain.~   "
82245|NCT02490423|"~     This study will determine whether a complex, data-driven protocol for assessing patient needs~     and providing nudges (reminders to be compliant with medication prescriptions) improves~     compliance with cardiovascular medications. This will be accomplished by performing a~     12-month clinical trial of patients with an indication for statin therapy. Participants will~     be randomized to either an intervention or standard-of-care arm and will be followed via~     passive electronic means to determine if they are compliant with medication prescriptions.~   "
82246|NCT02490410|"~     The purpose of this study is to compare the effects of different dose of whey protein~     intervention(in a daily dose of 0g, 10g, 20g) on lean body mass,body fat composition and~     muscular function state in the elderly with sacropenia.~   "
82247|NCT02490397|"~     The study tests if intense light could be a potential therapy in humans after myocardial~     infarction by inducing Per2.~   "
82248|NCT02490384|"~     This is a multicenter randomized study designed to determine if physical exam indicated~     cerclage reduces the incidence of spontaneous preterm birth <34 weeks in asymptomatic women~     with twin gestations and dilated cervix, diagnosed by pelvic exam between 16 to 23 6/7 weeks~     of gestation.~   "
82249|NCT02490371|"~     Stroke is the leading cause of function disability or impairment. Non-promising functional~     return from upper limb rehabilitation has been reported. With the technology advances,~     transcranial magnetic stimulation (TMS), which is a form of non-invasive direct brain~     stimulation, may act as an attenuator in regulating or modulating the cortical excitability~     in order to facilitate cortical re-organization and enhance behavioral performance. Various~     therapeutic exercise protocols have been investigated regarding their efficacy in promoting~     motor recovery of the affected upper limb for patients after stroke and the preliminary~     results were supportive. However, limited numbers of randomized control clinical trials have~     been published in investigating the priming or additive value of low frequency repetitive~     TMS (rTMS) with combination of structural motor training programs.~      Thus the objective of this study is: to determine the effectiveness of the combination of low~     frequency rTMS on contra-lesional M1 and a structured upper limb motor training program on~     restoring upper limb function among patients with stroke in sub-acute stage. It is~     hypothesized that the rTMS, when combined with a structured motor training program, confers~     additional therapeutic effects on upper limb motor function in subacute stroke patients, when~     compared with the motor training program alone.~      The objectives of this study is to determine the effectiveness of the combination of low~     frequent rTMS on contra-lesional M1 and a structured upper limb motor training program in~     restoring upper limb function among patients with subacute stroke.~   "
82250|NCT02490358|"~     This study will collect sputum samples from healthy smokers, COPD smokers and COPD ex-smokers~     to analyse biomarkers of inflammation~   "
82251|NCT02490345|"~     The specific aims of this research study are to use 600 mg gabapentin as an adjunctive~     treatment for acute postoperative pain control in order to reduce postoperative opiate~     consumption and improve postoperative pain control.~   "
82252|NCT02490332|"~     The prevalence of otitis media among Greenlandic children is one of the highest in the world~     and twenty per cent of schoolchildren have impaired hearing in the frequencies for normal~     speech. Yet, there are no national guidelines to ensure prevention and treatment of recurrent~     acute otitis media and chronic otitis media with effusion and impaired hearing in Greenlandic~     children. International studies from the developed part of the world have shown that otitis~     prone children may benefit from tubulation of the tympanic membrane. However, it is unknown~     if these results can be applied to Greenlandic children.~      This PhD project will conduct a randomised controlled trial comparing tubulation of the~     tympanic membrane, in Greenlandic children aged 9-36 months with recurrent acute otitis media~     and/or chronic otitis media with effusion, to conservative treatment. The children will be~     followed for two years. Outcome measures will include number of visits to health clinics,~     number of tympanic membrane perforations, number of episodes with acute otitis media~     according to medical records, Quality of life, measured by the validated questionnaires OM6~     and Caregiver Impact Questionnaire, number of episodes where per oral or intravenous~     antibiotics have been administered according to medical records and serious adverse events~      The trial will be conducted in collaboration with the Greenlandic health authorities and~     Copenhagen Trial Unit.~      With this trial the investigators hope to decrease the number of episodes with acute otitis~     media, the number of Greenlandic children with chronic perforations of the tympanic membrane~     and hearing impairment and increase quality of life.~      The results will add important knowledge to the effect of ventilation tube treatment also in~     an international aspect. There are to date only less than a handful of high quality studies~     concerning this issue on an international basis. The study will be among the first addressing~     this problem among populations with high risk of otitis media and is also of interest to~     other indigenous populations and the developing part of the world.~   "
82253|NCT02490319|"~     Radiation pneumonitis is the most common complication and the major dose-limiting toxicity~     associated with radiotherapy, which can cause poor quality of life or life-threatening~     symptoms and might hinder the tumor-controlling effects of radiotherapy. Consequently,~     establishing reliable predictors for the occurrence of RP is of great significance such that~     the therapeutic effects of RT can be maximized while minimizing its adverse effects. The aim~     of this study is to figure out the biological prediction models of radiation pneumonitis.~   "
82254|NCT02490306|"~     This is a prospective, open, multicentre trial that will enrol patients with clinical signs~     of stroke in the acute phase admitted for CT scan. Follow-up microwave measurements will be~     performed after the acute phase. The study assesses the diagnostic capability and safety of~     Strokefinder MD100.~   "
82256|NCT02490280|"~     The purpose of this study is to investigate how healthy youth and adults' cortisol levels and~     other hormone levels relate to anxiety levels while they participate in a behavioral task~     called the Trier Social Stress Task.~      Data from these healthy participants will also be compared to those of anxious youth and~     adults collected as part of the in the Principal Investigator's ongoing study titled,~     Child/Adolescent Anxiety Multimodal Extended Long-term Study (NA00035687).~   "
82257|NCT02490267|"~     The management of childhood glaucoma (CG), childhood cataract (CC) and other birth defects~     affecting the eyes requires frequent hospital attendances and often multiple surgical and~     medical interventions, and are often associated with poor vision. Chronic medical conditions~     and vision impairment can affect quality of life (QoL). The QoL of children with the above~     conditions has not previously been evaluated.~   "
82258|NCT02490254|"~     The investigators wish to establish a robust estimate of the incidence of inflammation inside~     the eye (uveitis) in children age 0-16 years in the UK, which hospitals children present to,~     where they are referred to, which treatment they receive during the first year after~     diagnosis, and how well they can see at the end of the first year.~   "
82259|NCT02490241|"~     Lithium, the gold standard for treatment of Bipolar Disorder (BD) and a common augmentation~     to medication therapy for Major Depression, is commonly continued in pregnancy due to its~     therapeutic benefit and more recent data that suggests the teratogenic effects of lithium are~     less than historically believed. Due to the increased elimination of lithium during~     pregnancy, lithium concentration decreases in the blood and women with BD are vulnerable to~     BD episode recurrence in pregnancy. Uncontrolled symptoms of BD in pregnancy increase the~     risk for postpartum exacerbation of BD and psychosis. Our study will investigate the~     pharmacokinetics (PK) of lithium prior to pregnancy, during pregnancy, and postpartum. Twenty~     women taking lithium in pregnancy or planning to become pregnant and continue lithium will be~     invited to participate in a study to measure repeated blood levels of lithium at six time~     points between preconception and 3 months postpartum. The data collected will inform the~     dose, timing of dose, and frequency of dosing of lithium that will lead to fewer untoward~     effects for the mother and baby. Change in elimination clearance of lithium will be~     correlated with symptom worsening to develop a dosing algorithm that will help maintain~     wellness for pregnant women with mood disorders.~   "
82260|NCT02490228|"~     To explore the minimally invasive and exhaustive treatment of female urethral canruncle by~     using trans-artificial-urethral resection of the canruncle. The investigators plant to~     recruit patients using this surgical method and study the effectivity of this method.~   "
82261|NCT02490215|"~     The acute respiratory distress syndrome(ARDS)has a high morbidity and mortality in patients~     admitted to intensive care units(ICUs). It represents a significant public health issue. No~     large nationwide, multicenters study of ARDS has been conducted in China. The purposes of~     this study are to analyse: 1)the incidence and outcomes of ARDS in ICU; 2) factors associated~     the mortality ; and 3) risk factors for development of ARDS .~   "
82262|NCT02490202|"~     Safety and efficacy study of SANGUINATE on reduction of delayed graft function (DGF) in~     patients who will be recipients of a donation after brain death (DBD) donor kidney.~   "
82263|NCT02490189|"~     To conduct a prospective, randomized trial to compare the efficacy of a group~     mindfulness-based intervention adapted for social anxiety disorder (MBI-SAD) versus cognitive~     behavior group therapy (CBGT).~   "
82264|NCT02490176|"~     Glucagon-like peptide-1 (GLP-1) is an incretin hormone that regulates plasma glucose, and~     GLP-1 analogues were recently introduced for the treatment of acute myocardial infarction.~     The investigators planned to evaluate the effects of liraglutide on haemodynamic parameters~     in patients with heart failure.~   "
82265|NCT02490163|"~     In a study performed in 2012, the investigators demonstrated that in ECP setting , the new~     automated device (Spectra Optia-MNC) released by Terumo BCT for MNCs collection based on~     intermittent flow is safe and ensures high-quality MNC collection and yield.(5, 6) More~     recently (in 2013), Terumo BCT released another automated system that allows to collect stem~     cells and MNCs basing on a continuous collection flow.(7, 8) The aim of this cross-over study~     is to compare yield (i.e. collection efficiency, CE) and quality (i.e. purity and~     contamination) of MNCs collected from patients undergoing ECP with two different automated~     systems: MNC and CMNC (Terumo BCT) processing 1.5 blood volumes during every collection~     procedure.~   "
82266|NCT02490150|"~     To evaluate if the administration of corifollitropin alfa on day 7 instead of on day 5 after~     pre-treatment with oral contraceptive pill results in a reduced total rFSH (recombinant~     follicle stimulating hormone ) consumption in a GnRH antagonist protocol in donors.~   "
82267|NCT02490137|"~     The purpose is to use MRI to investigate brain changes associated with playing a race car~     video game for 90 minutes in aging adults both with and without early signs of dementia.~   "
82268|NCT02490124|"~     Arterial vascular disease is the major cause of morbidity and mortality for Type 1 diabetic~     patients (DM1). Metabolic insulin resistance (metIR), even in the absence of hyperglycemia,~     conveys a 1.5 to 3-fold increased CVD risk in the general population. Metabolic Insulin~     Resistance (MetIR) has been repeatedly shown to be prevalent in adults and adolescents with~     DM1. MetIR in obesity and DM2 are accompanied by vascular insulin resistance (vasIR) which is~     characterized by impaired vasodilatory action of insulin on resistance or microvascular~     vessels. VasIR has not been systematically studied in DM1. We hypothesize that in young~     adults DM1 impairs both baseline and insulin-responsive vascular function throughout the~     arterial vasculature.~   "
82269|NCT02490111|"~     This study evaluates the efficacy and safety of DWJ1319 in the prevention of gallstone~     formation after gastrectomy in patient with gastric cancer. Two-thirds of the participants~     will receive DWJ1319, while the other will receive a placebo.~   "
82302|NCT02489682|"~     This study evaluates the effectiveness of a patient-centered short written informed consent~     form and a patient-centered short video informed consent in a randomized controlled trial~     (control = traditional informed consent ). Primary outcome measures include critical~     knowledge acquisition, risk and benefit judgments, and desired enrollment in a hypothetical~     clinical trial. The investigators hypothesized that the patient-centered patient-designed~     consent forms (video and written format) would do as well as or outperform the traditional~     consent form on the primary outcomes.~   "
82270|NCT02490098|"~     Current intensive insulin therapy in T1D involves prandial insulin boluses depending on the~     carbohydrate content of each ingested meal. Carbohydrate content of ingested meals is the~     main determinant of post-meal glucose excursion. Therefore, accurate carbohydrate counting is~     a critical aspect of managing postprandial blood glucose levels in type 1 diabetes in order~     to avoid too much or too little insulin resulting in hypoglycemia and hyperglycemia,~     respectively. Precision of carbohydrate counting is associated with better glycemic control.~     However, accurate carbohydrate counting is a challenging task for many patients with type 1~     diabetes. Recent developments of continuous glucose sensors and insulin infusion pumps have~     motivated the research toward closed-loop'' strategies to regulate glucose levels in~     patients with type 1 diabetes. In a closed-loop strategy, the pump insulin infusion rate is~     altered based on a computer generated recommendation that rely on continuous glucose sensor~     readings. A dual-hormone closed-loop strategy has also been recently proposed to regulate~     glucose levels. In a dual-hormone strategy, subcutaneous insulin delivery is accompanied by~     subcutaneous glucagon infusion. Postprandial meal glucose control with closed-loop strategy~     still needs some improvements. The objective of this study is to test in outpatient~     unrestricted settings whether, in the context of closed-loop strategy, conventional meal~     carbohydrate counting could be reduced to a simplified qualitative meal size estimation~     without a significant degradation in overall glycemic control in children and adult patients~     with type 1 diabetes. The investigators hypothesize that 1) dual-hormone closed-loop strategy~     with qualitative meal size estimation is equivalent to dual-hormone closed-loop strategy with~     CHO counting in terms of mean glucose; 2) single-hormone closed-loop strategy with~     qualitative meal size estimation is equivalent to single-hormone closed-loop strategy with~     CHO counting in terms of mean glucose;~   "
82271|NCT02490085|"~     The introduction of insulin pump therapy in patients with type 2 diabetes using multiple~     daily injections and poorly controlled can be considered in order to improve glycemic~     control. Recent developments of continuous glucose sensors and insulin infusion pumps have~     motivated the research toward closed-loop'' strategies to regulate glucose levels for~     patients with diabetes. In a closed-loop strategy, the pump(s) infusion rate is altered based~     on a computer generated recommendation that rely on continuous glucose sensor readings. This~     study confirmed the feasibility and potential of the closed-loop strategy to improve glycemic~     control while reducing the risk of hypoglycemia in patients with type 2 diabetes but did not~     target the population most likely to benefit from this strategy.The objective ot this study~     is to compare the efficacy of closed-loop strategy to multiple daily injections in regulating~     glucose levels for 24 hours in elderly adults with type 2 diabetes under intensive insulin~     therapy. The investigators hypothesize that closed-loop strategy will increase the time spent~     in the target range in adults with type 2 diabetes compared to multiple daily injections.~   "
82272|NCT02490072|"~     Dexmedetomidine is a selective α2 adrenergic agonist that can be considered a primary~     anesthetic, an adjuvant to propofol or inhalational anesthetics. Dexmedetomidine mediate its~     cardiovascular effect through activation of receptors in central and peripheral nervous~     system. The classic cardiovascular response of dexmedetomidine is the biphasic with initial~     shorten-increase in blood pressure followed by long-lasting decrease in BP and HR. There were~     several reports about these hemodynamic changs of dexmedetomidine, but not the evaluation of~     direct cardiac function of patients who was preexisted diastolic dysfunction. The purpose of~     this study is to evaluate the effects of dexmedetomidine as an anesthetic adjuvant in~     diastolic dysfunction by using the echocardiography.~   "
82273|NCT02490059|"~     The evaluation of solitary pulmonary nodules (SPN) requires a balance between~     procedure-related morbidity and diagnostic yield, particularly in areas where tuberculosis is~     endemic. Data on ultrathin bronchoscopy (UB) for this purpose is limited. In this prospective~     randomised trial we compared diagnostic yield and adverse events of UB with standard-size~     bronchoscopy (SB) in a cohort of patients with SPN located beyond the visible range of SB.~   "
82274|NCT02490046|"~     This is a study to explore the feasibility of using D-mannose, a commonly used food~     supplement, in persons with multiple sclerosis reporting recurrent urinary tract infections.~     Twenty persons with multiple sclerosis (10 patients using catheters and 10 not using~     catheters) reporting recurrent urinary tract infections will receive D-mannose 1.5 grams~     twice daily for 16 weeks duration.~      This will be explored through:~        1. Assessing compliance to a 16-week course of D-mannose~        2. Quantifying the number of prescriptions for antibiotics during the 16 weeks course of~          D-mannose~   "
82275|NCT02490033|"~     Catheter ablation is now routinely used in the management of heart rhythm disorders. One of~     the problems with the approach is that it has not been possible to determine whether the~     ablation catheter is in direct contact with the heart tissue or not. This is important~     because too much contact has safety implications and too little means that the therapy will~     be ineffective. Recently two different technologies have been developed to determine contact.~     Currently it is not know if one is superior to the other, and the objective of this trial is~     to determine whether there is a difference when treating a rhythm called atrial flutter.~   "
82276|NCT02490020|"~     Although donation after cardiac death(DCD) is the major source of renal transplantation in~     China, high incidence rate of rejection and delayed graft function(DGF) is existing due to~     the prolonged ischemia time. According to the previous single center study, mesenchymal stem~     cell (MSC) had an effect to prevent rejection and DGF after renal transplantation, but there~     was no perspective multicenter controlled study to confirm it. This perspective multicenter~     controlled study will focus on clarifying the key role of MSC applied via renal arterial or~     peripheral vein injection, to reduce the rejection and DGF after renal transplantation. The~     investigators have established GMP workshop and solid research foundation of transplant~     rejection. This study will provide a new reasonable way for immune induction of renal~     transplantation by DCD.~   "
82277|NCT02490007|"~     Aim To assess the possible food allergy-preventive benefit of using whole cell pertussis(wP)~     vaccination compared with acelluar pertussis vaccine(aP) for whooping cough vaccination in~     childhood.~      Background Whooping cough, caused by the bacteria, Bordetella pertussis, represents a~     significant public health burden in Australia and around the world. Acellular pertussis~     vaccination (aP) replaced whole cell vaccination against pertussis (wP) in the late 1990s.~     This replacement coincides temporally in an observed rapid rise in the occurrence of severe~     food allergy responses. Previous research has suggested that acellular pertussis vaccination~     results in the development of immunity that may predispose children to allergic responses. A~     retrospective case-controlled trial design, targeting cases of previously diagnosed allergy,~     and comparing case vaccination history to that of the whole population, is a powerful means~     of assessing the association between immunisation and allergy.~      Participant Groups 1000 allergy cases, 10,000 controls~      Project Design This is a retrospective individually-matched case-control study of Australian~     children born during the period of transition from use of wP vaccines to aP vaccines (year of~     birth 1997-1999 inclusive) and who are registered on the Australian Children Immunisation~     Register. Cases will be drawn from allergy clinics associated with tertiary teaching~     hospitals around Australia.~      Methods Cases: will be retrospectively identified from patient lists from allergy clinics~     around Australia, born during the period of pertussis vaccine changeover, and be confirmed to~     have IgE-mediated food allergy on the basis of 1) a documented history of consistent clinical~     symptoms following ingestion of an implicated food, and 2) evidence of sensitisation to that~     food via laboratory testing.~      Controls: Controls will be sampled from a de-identified database of children born during the~     transition from wP to aP vaccination appearing on the ACIR. Cases and controls will be~     matched by date of birth (+/-7 days), jurisdiction and socioeconomic decile.~      Expected outcomes: Following the study, investigators will be able determine if there is an~     association between the type of vaccination received and development of IgE mediated food~     allergy. If whole cell vaccination is found to have a protective association against the~     development of allergy, this will have profound impact on health policy in Australia and~     around the world.~   "
82280|NCT02489968|"~     Two independent study parts (i.e. Part A and Part B) are included in this trial. Part A will~     evaluate empagliflozin 10 mg + linagliptin and Part B will evaluate empagliflozin 25 mg +~     linagliptin. All analyses will be carried out separately for these study parts. The objective~     of Part A is to investigate the efficacy, safety and tolerability of the fixed dose~     combination (FDC) of empagliflozin 10 mg / linagliptin 5 mg compared with empagliflozin 10 mg~     plus FDC matching placebo administered orally once daily for 24 weeks in Japanese patients~     with T2DM who have insufficient glycaemic control after 16 weeks of treatment with~     empagliflozin 10 mg alone once daily. The study is designed to show superiority of the FDC of~     empagliflozin 10 mg / linagliptin 5 mg over empagliflozin 10 mg plus FDC matching placebo~     after 24 weeks of treatment. The objective of Part B is to investigate the efficacy, safety~     and tolerability of the FDC of empagliflozin 25 mg / linagliptin 5 mg compared with~     empagliflozin 25 mg plus FDC matching placebo administered orally once daily for 24 weeks in~     Japanese patients with T2DM who have insufficient glycaemic control after 16 weeks of~     treatment with empagliflozin 25 mg alone once daily. The study is designed to show~     superiority of the FDC of empagliflozin 25 mg / linagliptin 5 mg over empagliflozin 25 mg~     plus FDC matching placebo after 24 weeks of treatment. The 24 week treatment period will be~     followed by a 28 week extension treatment period to evaluate further efficacy and safety up~     to 52 weeks.~   "
82281|NCT02489955|"~     Adult patients with cystic fibrosis (CF) are treated with high dose antibiotics to reduce the~     long term damage to their lungs from infection. This would typically be with a two week~     course of intravenous antibiotics each time they have a chest infection (typically three to~     four times a year).~      The most effective and commonly used antibiotic in most cases is tobramycin. If this cannot~     be used because of previous side effects, allergy or a resistant infection then colomycin or~     amikacin are usually used. Each of these antibiotics are known to be toxic to both the~     kidneys and ear. As patients are living longer (into their forties), the total amount of~     these antibiotics they are receiving over their lifetime is increasing. This is now leading~     to increased complications such as kidney damage and hearing loss. Because of this, the~     investigators need to look at methods to accurately quantify damage and reduce potential~     kidney and hearing damage.~      The investigators intend to quantify kidney damage by measuring new protein markers within~     the urine and blood that signify kidney damage before more conventional and currently~     available methods are able to.In those patients treated with intravenous tobramycin the~     investigators will also look at an alternative method used to calculate the most appropriate~     dose of antibiotic for each participant. This dosing method is called 'area under the curve~     or AUC' dose monitoring. This method currently in clinical use in other countries is thought~     to more accurately reflect the most appropriate dose for each participant and thus reduce the~     chance of kidney and hearing problems. This 'AUC' method requires two rather than one dose~     level to be checked each time a dose calculation is made. Participants receiving tobramycin~     will be randomised to receive dosing by this method or the investigators' currently used~     method of 'trough' monitoring.~   "
82282|NCT02489942|"~     Study to investigate the safety and efficacy of long-term daily use of JARDIANCE® Tablets in~     Japanese patients with type 2 diabetes mellitus~   "
82283|NCT02489929|"~     Myelodysplastic syndrome (MDS) is a group of medical conditions derived from progressive bone~     marrow failure that result in ineffective production of blood cells. Depending on the~     severity, MDS reduces the quality of life to the point of being life-threatening. There is a~     probability of death at all stages of the disease, due to complications and co-morbidities,~     with progression to acute myeloid leukemia (AML) being the worst evolution. Azacytidine is a~     nucleosidic analog with original epigenetic mechanism of action that is widely used for~     treating a variety of myelodysplasic syndromes. Although generally well tolerated, severe and~     sometimes life-threatening toxicities were unexpectedly observed in some patients. Genetic~     polymorphism affecting cytidine deaminase (CDA), the liver enzyme responsible for azacytidine~     detoxification step, could be responsible for poor clinical outcome due to on the one hand to~     severe toxicities in deficient patients, and on the other hand on treatment failure in~     ultrametabolizer patients.This clinical study aims at correlating the values in CDA levels~     with the risk of drug-related toxicities and to the clinical response to azacytidine~     treatment.~   "
82284|NCT02489916|"~     The investigators do the clinical trial (patients with metastatic colorectal cancer treated~     with donafenib after failure of standard therapy) to assess safety and efficacy of donafenib~     in patients with metastatic colorectal cancer, progressing after all approved standard~     therapies.~   "
82285|NCT02489903|"~     The study is designed to explore the potential of the epigenetic agent RRx-001 to sensitize~     small cell and non-small cell lung cancer, ovarian cancer and high grade neuroendocrine tumor~     patients who previously responded and now have failed a platinum based doublet to the~     previously effective therapy.~   "
82286|NCT02489890|"~     Chemotherapy is the main treatment method for patients with Bladder Cancer. However, Relapse~     remains the major cause of treatment failure.Biological therapies such as CIK stimulate the~     immune system and stop tumor cells from growing. A series of studies reported that~     cytokine-induced killer cells (CIK) have a broad anti-tumor spectrum. The investigators~     suppose that CIK will improve the prognosis. Combining chemotherapy with biological therapy~     may kill more tumor cells. In this study, the patients will be treated with CIK cells after~     chemotherapy. The purpose of this study is to evaluate the efficacy of CIK for Bladder~     Cancer.~   "
82287|NCT02489877|"~     Multiple sclerosis is the most common autoimmune inflammatory disease of the central nervous~     system. It is known that your etiology has genetic and environmental causes. Several viruses~     have been implicated as triggers as well as perpetrators of this disease. Several studies~     make the correlation between Endogenous Retrovirus Type W (HERV-W) and the family~     Herpesviridae and activity in the pathogenesis of multiple sclerosis. The most important~     characteristics of the virus implicated in the pathogenesis of the disease is the fact that~     they have latency periods of exacerbation and they have, as their main biological~     environment, the central nervous system. The HERV-W, Epstein-Barr virus (EBV),~     cytomegalovirus, herpes virus type 6 and type 7 herpesvirus members are the most studied as~     causes of multiple sclerosis. It was found that these viruses are closely involved in the~     pathogenesis of MS, but it is believed that aren't the only responsible for its beginning. It~     is likely that this disease presents numerous triggers and more studies are needed to~     determine these interactions. In addition, a study comparing the activity of multiple~     sclerosis with the presence of these viruses was never realized.~   "
82359|NCT02488928|"~     EBUS elastography is a method to determine stiffness of lymph nodes, based on the minute~     deformation of the node by the beating heart. Whether EBUS elastography may further increase~     the sensitivity to predict the presence or absence of malignancy is unclear.~      We suggest to use EBUS elastography strain pattern analysis for this assessment and correlate~     these measurements with the final pathology outcome to determine NPV, PPV, sensitivity and~     specificity of this analysis to predict the presence or absence of malignancy in patients~     with (suspected) lung cancer in a prospectively obtained observational cohort study.~   "
82288|NCT02489864|"~     Appreciation of the central role for arterial vasodilatation in the pathogenesis of~     hepatorenal syndrome (HRS) has led to routine use of vasoconstrictors in combination with~     albumin as a medical therapy for HRS. Terlipressin have been explored but the optimal~     approach for such therapies has not yet been established. As compared with albumin, treatment~     with terlipressin and albumin is effective in improving renal function in patients with~     cirrhosis and hepatorenal syndrome. Our previous study showed that mean arterial pressure~     (MAP) is a predictor of hepatorenal syndrome occurrence in cirrhotic patients with ascites.~     The purpose of this study was to examine the role of targeting an early and substantial~     increase in mean arterial pressure in the prevention of type 2 HRS.~   "
82289|NCT02489851|"~     The Quadratus Lumborum block (QLB) was first described by Blanco in 2007. The main advantage~     of QLB compared to the Transversus Abdominis Plane block (TAP) is the extension of local~     anesthetic agent beyond the TAP plane to the thoracic paravertebral space. The wider spread~     of the local anesthetic agents may produce extensive analgesia and prolonged action of the~     injected local anesthetic solution.~      Previous studies showed that both TAP block and QLB may reduce morphine requirements in the~     postoperative period in patients who had cesarean section under spinal anaesthesia. However~     there are no published reports comparing the 2 techniques.~      The aim of this randomised controlled, double blinded study is to compare the analgesic~     efficacy of QLB compared to TAP block in patients who had cesarean section under spinal~     anesthesia.~   "
82290|NCT02489838|"~     To Calculate the amount radiation the lung receives in patients receiving Yttrium-90 for~     Liver Cancer.~   "
82291|NCT02489825|"~     Vertebroplasty itself is challenged regarding its clinical efficacy. While two randomized~     controlled trials (RCTs) with substantial methodological problems have led to an intense~     discussion another RCT with larger case numbers, more representative inclusion criteria and a~     more consistent and sound methodology has revealed results that mirror the investigators' own~     clinical experience. In their daily practice, the investigators have further advanced their~     treatment concept and routinely apply prophylactic augmentations with VP using an algorithm.~     Biomechanical studies support their approach, but clinical studies are rare so far.~     Prophylactic augmentation with balloon kyphoplasty has not shown convincing effects in a~     small pilot study. Given the above mentioned methodological and clinical disputes and the~     call for high-evidence studies about VP, the investigators aim at generating a reliable~     sample size calculation and preliminary results for a future multicenter RCT about~     prophylactic adjacent level augmentation with VP in single level osteoporotic compression~     fractures.~   "
82292|NCT02489812|"~     Music plays an important role reassuring helping reduce anxiety. Anxiety can be an~     interference factor in promoting oral health for children with high levels of anxiety tend to~     have negative behavior at the dentist. High oxygen levels and heart and respiratory~     frequencies are associated with high levels of anxiety. The objective of this study was to~     test the use of music in decreased cardiac and respiratory frequency of treated patients~     listening to music and being treated without hearing music.~   "
82293|NCT02489799|"~     Through close engagement with our patient and family member co-investigators, the~     investigators have developed a video-based advance care planning aid for cancer patients and~     their family members who are preparing for major surgery. In this study, patients are~     randomized to see either the intervention video (involving advance care planning-related~     content) or a control video (no advance care planning-related content) prior to surgery. The~     investigators hypothesize that the video will lead to more and better preoperative~     discussions between the patient and surgeon that are related to advance care planning. The~     investigators also hypothesize that seeing the advance care planning-related video will~     decrease perioperative anxiety and depression scores.~   "
82294|NCT02489786|"~     Digoxin is the primary cardiac glycoside in clinical use. Because of the narrow therapeutic~     index and risk of toxicity, therapeutic drug monitoring is highly recommended. In Egypt, most~     cardiologists give digoxin holiday for both atrial fibrillation and heart failure, it is not~     clear if the interrupted digoxin regimens are effective since serum digoxin concentrations~     might fall below the therapeutic range.~      Objective: To evaluate and compare the digoxin serum concentration and patient's quality of~     life in the continuous versus interrupted digoxin dosing regimens.~   "
82295|NCT02489773|"~     To confirm that Lucica ® Glycated Albumin-L is useful for the intermediate term (preceding~     2-3 weeks) monitoring of glycemic control in patients with diabetes.~   "
82296|NCT02489760|"~     To determine the safety and efficacy of switch effects to adalimumab in etanercept-treated AS~     patients.~   "
82297|NCT02489747|"~     The investigators performed a 12-week, randomized, double-blind, placebo-controlled human~     trial to evaluate the efficacy and safety of water extract from wheat Triticum aestivum L on~     cognitive and memory function. The investigators measured changes in cognitive function~     parameters, including CNT, WMT, K-MMSE, BCRS, PRMQ, PSS, SF-36 and BDNF~   "
82298|NCT02489734|"~     The purpose of this study is to determine whether the incidence of emergence delirium will be~     reduced when end-tidal concentration of sevoflurane decreases.~   "
82299|NCT02489721|"~     Most important peripherally inserted central catheter (PICC) and Midline complications are~     thrombosis and catheter related blood stream infections. No large prospective observational~     study are present in literature about these topics. The aim of this multicenter prospective~     observational study is to analyze all the complications due to PICC and Midline insertion.~   "
82300|NCT02489708|"~     This two phase study will develop and evaluate a Pediatric Emergency Department (PED)~     Decision Support System (DSS)-Electronic Medical Records (EMR) System to facilitate the~     identification of smokers and the delivery of a Second Hand Smoke (SHSe) exposure~     intervention to caregivers who bring their child to the PED.~   "
82301|NCT02489695|"~     Multicenter, single arm, phase II study using a A'Hern single-stage procedure in patients~     with locally advanced or metastatic papillary renal cell carcinoma (PRCC) in first-line~     treatment.~   "
82360|NCT02488915|"~     The study objective is to examine the recanalization efficacy of the EmboTrap device and its~     associated performance characteristics and to record associated clinical outcomes in a manner~     that facilitates relevant comparison of outputs with that of devices approved in the U.S. for~     clearing Large Vessel Occlusions.~   "
82303|NCT02489669|"~     The urine flow rate (UFR)-guided and the left-ventricular end-diastolic pressure~     (LVEDP)-guided hydration regimens have been proposed to prevent contrast-induced acute kidney~     injury (CI-AKI). The REnal Insufficiency Following Contrast MEDIA Administration TriaL III~     (REMEDIAL III) trial is a randomized, multicenter, investigator-sponsored trial aiming to~     compare these 2 hydration strategies in high risk patients.~      Patients with estimated glomerular filtration rate <45 ml/min/1.73 m2 and/or a high risk for~     CI-AKI (as defined according to both Mehran's score ≥11 and/or Gurm's score >7) will be~     enrolled. Patients will be divided in high (>12 mm Hg) and normal LVEDP, non-invasively~     estimated by transmitral flow velocity to annular velocity ratio (E/E' index). Patients in~     each group will be randomly assigned to 1) LVEDP-guided hydration with normal saline~     (LVEDP-guided group). The fluid infusion rate will be adjusted according to the LVEDP as~     follows: 5 mL/kg/hr for LVEDP <12 mmHg; 3 mL/kg/hr for 13-18 mmHg; and 1.5 mL/kg/hr for >18~     mmHg. 2) UFR-rate guided hydration (RenalGuard group). In this group, hydration with normal~     saline plus low-dose of furosemide is controlled by the RenalGuard system, in order to reach~     and maintain a high (>300 mL/h) UFR. In all cases iobitridol (an low-osmolar, non ionic~     contrast agent) will be administered. The primary endpoint is the composite of CI-AKI (i.e.,~     serum creatinine increase ≥ 25% and ≥ 0.5 mg/dl from the baseline value at 48 hours after~     contrast media exposure) and/or acute pulmonary edema.~   "
82304|NCT02489656|"~     This study is a prospective, randomized multicenter study conducted in Europe. It is designed~     to compare two double loop ureteral stents in terms of the quality of life in patients~     operated on a kidney stone and requiring the placement of a double loop ureteral stent at the~     end of the operation.~   "
82305|NCT02489643|"~     The aim of the study will be to evaluate the impact of this individualized practical training~     on efficacy (evaluated by Psoriasis Area and Severity Index (PASI) and Body Surface Area~     (BSA) score performed by a physician blinded to the study groups) and adherence (calculated~     as days wherein gel was applied and as BSA/weight of gel applied rate) to a 4 week long~     treatment with dovobet gel. On the other hand, the investigators will evaluate in both groups~     as demographic (as sex, age, job,..) or disease (as severity, duration, impact of quality of~     life,..) characteristics influence the adherence to the treatment.~   "
82306|NCT02489630|"~     This study investigates the use of low doses of ketamine, along with opiate pain medication,~     is more effective at controlling the acute pain of patients in the emergency department than~     opiate pain medication alone. In addition, this study examines whether patients treated with~     low doses of ketamine, along with opiate pain medication, will require less opiate pain~     medication to control their pain, and whether these patients are equally happy with their~     pain control as patients who receive only opiate pain medication.~   "
82307|NCT02489617|"~     This research study is studying a surgical intervention to rule out the presence of cancer in~     participants that have been diagnosed with flat epithelial atypia (FEA) or intraductal~     papilloma without atypia (IPWA) by core needle biopsy.~   "
82308|NCT02489604|"~     This is a randomized phase II non-comparative study. Patients with gastroenteropancreatic~     Neuroendocrine tumour (GEP-NET) G1-G2 with progressive disease, SSR positive and FDG negative~     will be enrolled in the study and will be randomly assigned to 2 different dosages (total~     activity of 25.9 GBq and total activity of 18.5 GBq).~   "
82309|NCT02489591|"~     Obstructive Sleep Apnea (OSA) is characterized by collapse of one or more pharyngeal~     structures during sleep (velum, tongue base, lateral walls, epiglottis). Structure-specific~     therapies for OSA have emerged as alternatives to positive airway pressure (PAP). Oral~     appliance (OA) therapy is increasingly being indicated for OSA treatment, although a complete~     response occurs in approximately 50% of patients. In general, OA devices are designed to~     maintain the mandible and/or tongue in a protruded posture during sleep, preventing upper~     airway obstruction. Limited studies in awake or sedated patients have demonstrated the~     effects of mandibular advancement on aspects of pharyngeal structure and function. The~     objective of the proposed research is to fully characterize upper airway collapse in OSA~     patients during natural sleep and use this information to understand why some patients appear~     to exhibit a large improvement in pharyngeal collapsibility whereas others do not.~   "
82310|NCT02489578|"~     The purpose of this study is to evaluate the disease burden of hospitalized patients with CAP~     and healthcare-associated pneumonia (HCAP) in real life of China .~   "
82311|NCT02489565|"~     The purpose of this study is to determine whether the telemedicine use in primary health care~     is effective in the accompaniment of stable coronary artery disease patients who were~     discharged from the tertiary health care clinics.~   "
82312|NCT02489539|"~     The purpose of the study is to assess the safety and effectiveness of the GORE® EXCLUDER®~     Conformable AAA Endoprosthesis to treat an infrarenal aneurysm located in the abdominal~     aorta. Performance of the GORE® EXCLUDER® Conformable AAA Endoprosthesis will be judged by~     separate performance goals.~   "
82313|NCT02489526|"~     The purpose of this Phase 2 study is to evaluate the efficacy and safety of an analgesic drug~     candidate, VVZ-149 Injections. The study is designed as randomized, double-blind, parallel,~     placebo-controlled study.~   "
82314|NCT02489513|"~     The study is designed to characterize the absorption, metabolism, and excretion of AG-120~     using radiolabeled drug in healthy adult male subjects to support its further development and~     registration.~   "
82315|NCT02489500|"~     Standard treatment for AL Amyloidosis is high-dose melphalan and stem cell transplant.~      This study will compare the safety and effectiveness of standard treatment with high-dose~     melphalan and stem cell transplant, compared with investigational bortezomib when used in~     combination with standard treatment with high-dose melphalan and stem cell transplant for AL~     amyloidosis.~   "
82316|NCT02489487|"~     A randomized single dose, drug-drug interaction study in healthy volunteers for VM - 1500~     given alone or in combination with Raltegravir or Darunavir in a 3 arm approach. The parallel~     design is used due to the long half life for VM-1500.~   "
82317|NCT02489474|"~     Some of the liver transplantation recipients experience postoperative acute kidney injury due~     to various causes including genetic factors. Prevention of postoperative acute kidney injury~     is essential for postoperative care in liver transplantation recipients. The aim of this~     study is to investigate the relationship between gene polymorphisms which have been known to~     be associated with postoperative acute kidney injury, and the occurrence of acute kidney~     injury after liver transplantation.~   "
82318|NCT02489461|"~     To evaluate the following safety and efficacy parameters for VM-1500:~        -  Decrease in viral load to non-quantifiable level (<50 copies/ml) at Week 12 (Stage I)~        -  Decrease in viral load to non-quantifiable level (<50 copies/ml) at Week 24 (Stage II)~        -  Decrease in viral load during 48 weeks of treatment~        -  Percentage of subjects with at least 10-fold (1 log10) decrease in viral load at Week 4~        -  Percentage of subjects with decrease in viral load to <400 copies/ml at Week 12~        -  Percentage of subjects who continued to receive the investigational treatment up to Week~          48~        -  СD4+ and СD8+ cell count change during 48 weeks of the study~        -  Percentage of subject who developed HIV-1 resistance to the investigational treatment by~          week 48~        -  Frequency of adverse events (AE) of different severity according to subjective~          complaints, physical assessment, vital signs, laboratory tests, ECG~        -  Frequency of adverse events of special interest, including of central nervous system~          (CNS) effects~        -  VM-1500 pharmacokinetic profile in selected subjects~   "
82319|NCT02489448|"~     The purpose of the study is to address the following hypotheses: (i) Anti-PD-L1 therapy with~     MEDI4736 administered concomitantly with weekly nab-paclitaxel followed by MEDI4736~     concomitant with ddAC neoadjuvant chemotherapy will induce higher pathologic complete~     response (pCR) rate (>55%) in triple negative breast cancer than historical pCR rates~     (30-40%) observed with chemotherapy alone. (ii) MEDI4736 can be safely co-administered at~     full dose with sequential with nab-paclitaxel (100mg/m2) and ddAC (60 mg/m2 and 600 mg/m2~     respectively).~   "
82320|NCT02489435|"~     The purpose of the study to assess safety and tolerability of VM-1500 and to determine main~     pharmacokinetic parameters of VM-1500 after multiple oral administration in adult healthy~     subjects.~   "
82321|NCT02489422|"~     This randomized pilot trial studies how well two supportive programs work for improving~     fatigue and depressive symptoms in patients with stage II-IV colorectal cancer undergoing~     chemotherapy. Possible mediators such as psychological stress, circadian disruption, and~     inflammation, will also be explored.~   "
82322|NCT02489409|"~     Endostatin has been widely applied for the clinical treatment of partial primary and~     metastatic solid tumors. Endostatin combined with chemotherapy has achieved favorable~     progression in the treatment of non-small cell lung cancer (NSCLC). However, the research~     about the efficacy of Endostatin on breast cancer has just started. Breast cancer is a~     highly-differentiated solid tumor, indicating that it is also an indicator for Endostatin~     therapy. Additionally, after chemo- and radiotherapy, the primary nidi of patients with~     advanced breast cancer may also lead to rapid development of tumors in other locations. So~     Endostatin combined with chemotherapy can also improve the prognosis of patients with~     recurrent metastatic breast cancer, but there is rare any report at home and abroad. To~     further explore the above research, this study designed a randomized, opened and controlled~     clinical study to observe the clinical efficacy of EndostarTM Injection combined with~     GP/NP/GX/NX in the treatment of recurrent metastatic breast cancer.~   "
82323|NCT02489396|"~     Rationale: Online-grocery shopping is predicted to be one of the hottest food trends of~     2014, as national retailers such as Amazon, as well as start-up companies, venture into the~     e- commerce grocery sector. Importantly, the online-grocery environment could be uniquely~     manipulated to promote healthier food purchasing and help with weight control. Since~     consumers tend to choose items listed first on menus and buffet lines, the order of food~     products displayed on the grocer's website may impact purchasing. Furthermore, it's possible~     that in an online-grocery environment, nutrition information could be made more salient to~     consumers. For example, previous research has demonstrated that label color influences~     perceptions of the healthfulness of foods. The FDA also recently proposed a redesign of~     foods' nutrition facts panels, which would highlight calorie content in a larger font.~     Although implementing this label change on all food labels could take years, e-commerce sites~     could change the format of the nutritional information they display much more quickly.~      Objectives: The proposed study intends to nudge consumers to make healthier grocery purchases~     through three distinct interventions: 1.) Manipulating the order of food items within grocery~     categories; 2.) Displaying product nutrition information in red or green; and 3.) Presenting~     calorie information in a larger font size. We propose to examine these concepts in adult~     consumers using a grocery e-commerce platform servicing socioeconomically and racially~     diverse communities in the northeastern U.S.~   "
82324|NCT02489383|"~     The treatment of asthma is based in clinical control. However, previous studies have been~     shown that patients that participate of the programs of regular or aerobic continuous~     exercise training (CT) presented improvements in the physical conditioning, and quality life,~     as well as decreased the levels of anxiety and depression, reduced the oxide nitric exhaled~     and leukocyte migration at the airways and reduced the airway hyperresponsiveness. The~     regular exercise also is important part in the rehabilitation of other lung disease as well~     as chronic obstructive pulmonary disease (COPD). Additionally, others studies have been shown~     the effects of high intensity interval training (IT) in the pulmonary rehabilitation of COPD~     patients, that after performed IT presented reduction of dyspnea, and increase the physical~     capacity. In this sense, the impact of IT in the asthmatic patients at the present moment is~     poorly studied, and necessity of the more investigation to prove the efficiency of this~     training model for asthma patients.~   "
82339|NCT02489188|"~     To date, detailed analysis of movement patterns in orthopaedic conditions are mainly~     performed in research projects. Because these tests are time consuming, they are not feasible~     in clinical routine or in standard examinations. Novel technologies allow capturing detailed~     movement patters within a few minutes. The aim of this regional study is to compare aspects~     of movement tasks measured using a mobile gait analysis system to those measured using~     laboratory based systems and to determine aspects of gait patterns relevant for different~     orthopaedic conditions. Moreover, the researchers will investigate if these relevant aspects~     can be altered using surgical treatment or manual therapy.~   "
82361|NCT02488902|"~     This was a randomised, double-blind, placebo-controlled study to compare the efficacy of a~     range four weekly doses of tafenoquine, and weekly mefloquine, with placebo as~     chemosuppression of P. falciparum malaria. Medications and placebo were matched and a~     double-dummy technique enabled blinding of tafenoquine versus mefloquine.~   "
82362|NCT02488889|"~     This laboratory study will examine if varenicline can reduce alcohol-induced smoking lapse in~     heavy drinking smokers.~   "
82325|NCT02489370|"~     Providing patients with chronic heart failure (CHF) access to remote monitoring, for example~     by telephone or telemonitoring using wireless technology, reduces deaths and hospitalisations~     and may provide benefits on health care costs and quality of life. Remote monitoring of~     patients with chronic heart failure can reduce pressure on resources, particularly for~     conditions like chronic heart failure, which exert a large burden on health services. These~     are conclusions of the Cochrane Systematic Review from 2010.~      In Norway the costs for treatment of chronic heart failure are vast, both concerning hospital~     treatment, daily use of medication over years, and loss of quality of life for patients and~     their family caregivers. Generally there is little knowledge about what is gained for the~     billions used. In Norway no telemonitoring services are established and hence no~     investigations have yet been published. Thus it seems that current evidence of effectiveness~     and quality is insufficient to recommend usage. The structure and funding streams in~     Norwegian health services are different from other countries and the conventional services~     that the intervention has been compared to in previous studies, are most likely~     heterogeneous. It is thus important to investigate Norwegian conditions.~      Advanced telemonitoring technology with electronic transfer of physiological data such as~     blood pressure and weight is currently being used in research and established routine~     services in several countries in Europe, amongst them the Netherlands, Germany and the United~     Kingdom.~      The proposed project intends to introduce such a strategy as an avenue for exploring~     promising new services that would not otherwise be available in Norway. The service consists~     of daily monitoring the patients' weight and blood pressure directly from their home;~     automatically and securely transmit the values to a server at the University Hospital of~     North Norway (UNN); and monitor the values by a trained nurse at the Heart polyclinic.~      The primary objective of this study is thus to explore whether, as compared to current care~     from the Heart Polyclinic, the introduction of home telemonitoring will reduce hospital~     readmissions and will, in addition, be cost-effective. This is in line with current~     directions of European telemonitoring programmes for patients with chronic heart failure.~     This result may define if the telemonitoring of heart failure patients is feasible for Norway~     or not at all.~   "
82326|NCT02489357|"~     This pilot phase II trial studies the side effects and how well pembrolizumab and cryosurgery~     work with short term androgen ablation to treat patients with prostate cancer that has~     traveled from the original tumor, through the body, and formed a small number of new tumors~     in other parts of the body (oligo-metastatic). Cryosurgery, also known as cryoablation or~     cryotherapy, kills tumor cells by freezing them. The process also incites an immune response~     within the ablated tumor. Giving monoclonal antibodies such as pembrolizumab which enhance a~     systemic anti-cancer immune response, may augment the effects of cryosurgery and increase~     tumor killing at distant (metastatic) sites.~   "
82327|NCT02489344|"~     Primary Objective:~      To assess the long-term safety of GZ/SAR402671 in adult male patients with Fabry disease who~     previously completed study ACT13739.~      Secondary Objective:~      To assess the long-term effect of GZ/SAR402671 on pharmacodynamic and exploratory efficacy~     endpoints in adult male patients with Fabry disease who previously completed study ACT13739.~   "
82328|NCT02489331|"~     Post marketing surveillance of safety and efficacy for Cholib in Korean patients under the~     New Drug Re-examination~   "
82329|NCT02489318|"~     The purpose of this study is to determine if the addition of apalutamide to ADT provides~     superior efficacy in improving radiographic progression-free survival (rPFS) or overall~     survival (OS) for participants with mHSPC.~   "
82330|NCT02489305|"~     The purpose of this study is to identify if there are self-reported or objective measures~     related to mood parameters that can predict near-term relapse (within 1 month or at another~     identified time point before meeting the criteria for relapse) or early symptomatic changes~     indicative of relapse prodrome in major depressive disorder (MDD).~   "
82331|NCT02489292|"~     The aim of the study is to assess the efficacy of HepaStem treatment in paediatric patients~     suffering from urea cycle disorders.~   "
82332|NCT02489279|"~     The purpose of this study is to evaluate the effects of different types of cognitive training~     on attention in adults with Attention Deficit Hyperactivity Disorder (ADHD) using mobile~     software on personal mobile devices.~   "
82333|NCT02489266|"~     Background:~      - One cancer therapy involves taking white blood cells from a person, changing them in a lab,~     and then giving the cells back to the person. These cells are called tumor infiltrating~     lymphocytes (TIL). Researchers want to grow some of the TIL cells with the drug Akti to see~     if they live longer than those grown without it.~      Objectives:~      - To see if TIL cells grown with Akti live longer than those grown without it.~      Eligibility:~      - Adults 18 70 with metastatic melanoma~      Design:~        -  Participants will:~        -  Be screened with tests including scans, x-rays, heart and lung tests, blood and urine~          tests, and a <TAB>possible colonoscopy.~        -  Have tumor surgery or biopsy.~        -  Have a large catheter inserted into a vein in the upper chest.~        -  Receive leukapheresis for 4 5 hours. Blood is removed through a needle in an arm. White~          blood cells <TAB>are removed. The rest of the blood is returned by needle in the other~          arm.~        -  The cells will be changed in a laboratory.~        -  Participants will check into the hospital and:~        -  For 5 days, get 1 2 chemotherapy drugs by catheter.~        -  For 1 3 days, get the changed cells by catheter.~        -  For several days, get 2 drugs to stimulate cells, one by injection, the other by~          catheter.~        -  For 7 12 days, recover in the hospital.~        -  After treatment, participants will:~        -  Take an antibiotic and antiviral for at least 6 months.~        -  Return to NIH for several 2-day visits for a few years. At each visit, participants will~          have lab tests, imaging studies, and a physical exam. At some visits, they may have~          leukapheresis or blood tests.~   "
82334|NCT02489253|"~     Familial hypercholesterolemia (FH) is a common inherited disorder with a frequency of 1 in~     500 in the UK. Our aim is compare the carotid and coronary artery atherosclerosis in~     monogenic FH and polygenic hypercholesterolemia with means of a carotid ultrasound, a~     coronary CT angiogram and biochemical biomarkers.~   "
82335|NCT02489240|"~     The investigators planned to research the effect of vitamin D supplementation on the~     incidence of contrast-induced nephropathy in patients undergoing coronary angiography.~   "
82336|NCT02489227|"~     This is a 3-part study comparing CHS-1420 to Humira in patients with chronic plaque~     psoriasis.~   "
82337|NCT02489214|"~     This open-label, one-center, noncomparative, two-stage phase 1B trial assessed the donafenib~     in advanced gastric cancer.~   "
82338|NCT02489201|"~     This open-label, one-center, noncomparative, two-stages phase 1B trial assessed the tyrosine~     kinase inhibitor donafenib tosylate tablets(400 mg/d,200mg bid) in patients with advanced,~     inoperable oesophageal cancer progressing after chemotherapy .~      The primary endpoint is the safety.The secondary endpoints are tumor response and~     progression-free survival.~   "
82536|NCT02486614|"~     The aim of this study is to evaluate the effect of regional citrate anti-coagulation on~     different pathways of the coagulation system in critically ill patients with acute kidney~     injury. This will form the basis for future studies where the investigators plan to focus on~     patients with premature circuit clotting despite optimal post-filtrate ionised calcium~     parameters.~   "
82340|NCT02489175|"~     Parastomal hernia (PSH) is one of the most frequent stoma complications with a high impact on~     patients' quality of life. Half of the stomas created each year are permanent and up to 50%~     of the patients will develop a PSH. PSH rates depend on the type of ostomy, ileo- or~     colostomy. End colostomy carries the highest risk for PSH (48%). PSH lead to recurrent pain,~     poor fitting appliance with leakage and therefore, skin irritation, and can also be~     complicated by strangulation or occlusion. The literature reports that 30% of patients with a~     PSH will require surgery. There are many different surgical procedures to repair PSH: primary~     fascia repair, relocation of the stoma or repair with various type of mesh. Despite the~     efforts done to improve the techniques, the incidence of recurrent PSH is up to 70% dependent~     of the used technique. Therefore, the idea of implanting a mesh at the time of initial stoma~     formation has lately been advocated. A new device, the KoringKM, which is a stomaplasty ring~     made of propylene, flexible and non-absorbable, was created. This study will try to prove~     that incorporation of the new stomaplasty ring at the time of stoma creation will diminish~     long-term PSH rate. This hypothesis will improve patient's quality of life and reduce costs~     associated with PSH.~      All patients requiring a permanent ostomy (ileostomy or colostomy) for a malignant disease~     and fulfilling the inclusion criteria are eligible to participate in the trial. The patients~     will be randomized 24 to 48 hours prior to surgery after given written informed consent. The~     implantation of the Koring will be perfomed by experienced surgeons (expertise based, best~     team approach) who have already implanted the Koring (e.g. participated in the observational~     study) and/or have reviewed the video documentation. The surgeon will fill out the first form~     with the data of the patient and of the surgical procedure. The surgical wound will be daily~     examined. A second form will be fill out during the 30 post-operative days visit. The~     patients will be asked to inform the surgeon and/or investigator if any side event or~     suspicion of infection occurs after hospital discharge. The next follow-up visits will be at~     one and two years including a clinical examination and an abdominal CT. At this moment, the~     3rd and 4th forms will be documented. All data will be anonymised and included in an Excel~     database.~   "
82341|NCT02489162|"~     The objective of the research is to determine whether the MyotonPRO has a valid and reliable~     application in facial, head and neck surgery. In addition, the study aims to compare this new~     technology with current electromyography.~   "
82342|NCT02489149|"~     To optimize the food security in quilombolas communities with high prevalence of food~     insecurity and obesity, the present study proposes to test a multi-sector intervention~     including agriculture sectors, health professionals and family members of communities, based~     on promotion of traditional food practices, health eating and enforceability of human right~     to adequate food.~   "
82343|NCT02489136|"~     Stress is a multiple variable and an inevitable aspect of life. Any change that affects the~     life of a person is a stressful agent, being possible to widely vary its nature and may be~     formed by several components, since psychosocial and behavioral factors, such as frustration,~     anxiety and overload. The goal is to assess the effects of laying on of hands on newborns and~     patients without direct physical contact. Newborns are allocated in two three groups: G1 -~     group submitted to imposition of hands by workers, for a period of 10 minutes; G2 group~     submitted to laying on of hands for 10 minutes; and adults are allocated three groups: G1 -~     group submitted to imposition of hands by workers, for a period of 10 minutes; G2 group~     submitted to laying on of hands for 10 minutes; in G3: group without intervention, for a~     period of 10 minutes.~   "
82344|NCT02489123|"~     This pilot clinical trial studies enzalutamide in treating patients with mantle cell lymphoma~     that has returned after a period of improvement (relapsed) or has not responded to previous~     treatment (refractory). Androgens can cause the growth of cancer cells. Antihormone therapy,~     such as enzalutamide, may lessen the amount of androgen made by the body.~   "
82345|NCT02489110|"~     Photozig and Stanford University are creating a new program for Hispanic dementia caregivers~     to help cope with caregiving, alleviate related stress, and enhance quality of life for~     caregivers, with funding from the National Institute on Aging. The program includes a new~     education online telenovela (Webnovela), online resources, handouts and a DVD (for users~     without Internet) on how to deal with caregiving stress and handle difficult situations.~   "
82346|NCT02489097|"~     The study is a substudy of the Enigma2 trial which aims at investigating the effectiveness~     and safety of nitrous oxide (N2O) in anaesthesia.The substudy focus is on postoperative~     cognitive disorders.~      Substudy Hypothesis: In patients undergoing anaesthesia for major surgery, administration of~     N2O will reduce postoperative cognitive disorders when compared with otherwise identically~     managed surgical patients not receiving N2O as a component of their anaesthesia.~   "
82347|NCT02489084|"~     Background of the study:~      Swallowing dysfunction and xerostomia are the most frequently reported radiation-induced side~     effects (RISE) after (chemo) radiation ((CH) RT) in head and neck cancer (HNC) patients and~     have a major impact on the general dimensions of quality of life (QoL). In~     radiation0oncology, normal tissue complication probability (NTCP) models based on dose-volume~     parameters being used to determine the risk of acute and late RISE. NTCP models containing~     genetic determinants of radiosensitivity, such as single nucleotide polymorphisms (SNPs), may~     improve model performance and thus enable more individualized radiotherapy. Information of~     the predictive value of SNPs or SNP signatures among patients with HNC is currently not~     available.~      Objective of the study:~      The main objective of this project will be to test the hypothesis that SNP profiles can~     improve the performance of predictive models for the most frequently reported late RISE, i.e.~     dysphagia, in HNC patients after curative (CH) RT. Secondary objectives will be improvement~     of NTCP models for HNC patients by adding SNP profiles predictive of (1) acute mucositis; (2)~     acute dysphagia; (3) salivary dysfunction; (4) acute xerostomia; (5) late xerostomia; (6)~     osteoradionecrosis; (7) hypothyroidism; (8) patient-rated HNC symptoms and ; (9) quality of~     life.~   "
82348|NCT02489071|"~     This study evaluates the feasibility and utility of two behavioural programs designed to~     reduce cognitive impairments secondary to brain tumors and/or their treatment. One-third of~     participants will complete training in either program, with the remaining third a wait-list~     control group.~   "
82349|NCT02489058|"~     This is an observational and sample collection study involving patients (alive or deceased)~     from several clinical trials who had received the investigational drug, olaparib in other~     research studies. There is no intervention given for this study.~      This research is being done to understand of the mechanisms involved in patients whose cancer~     responds well and whose cancer does not respond well to investigational drug, olaparib, to~     help better understand how olaparib works and to better identify patients who may benefit~     from this therapy.~   "
82424|NCT02488070|"~     This clinical trial studies gallium-68 (68Ga)-prostate specific membrane antigen (PSMA)~     (gallium Ga 68-labeled PSMA ligand Glu-urea-Lys[Ahx]) positron emission tomography~     (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI) in identifying~     prostate cancer that may have returned after a period of improvement (biochemical~     recurrence). 68Ga-PSMA is a radiopharmaceutical that localizes to a specific prostate cancer~     receptor, which can then be imaged by the PET/CT or PET/MRI scanner.~   "
82350|NCT02489045|"~     This is an open-label, non-randomized trial that will be conducted at two clinical sites,~     Thomas Jefferson University (TJU) and the Hospital of the University of Pennsylvania (HUP).~     Enrolled patients undergoing trans-jugular liver biopsy with hepatic vein pressure gradient~     (HVPG) measurements will receive a continuous infusion of Sonazoid® (GE Healthcare, Oslo,~     Norway) co-infused with 0.9% NaCl solution over a 5-10 minute time period. Ultrasound imaging~     will be performed using a Logiq 9 scanner with a 4C transducer (GE Healthcare, Milwaukee, WI)~     and the novel SHAPE (subharmonic aided pressure estimation) algorithm will be used to measure~     pressure values in the hepatic and portal veins. Data will be stored on a PC and compared to~     pressure-catheter measurements, Subjects identified in the initial examination as having~     portal hypertension (by HVPG results) will be monitored by SHAPE for up to 18 months. These~     subjects typically have surveillance Computed tomography (CT) or magnetic resonance imaging~     (MRI) scans every 6 months to screen for liver cancer, and at those times a repeat SHAPE~     examination will be performed (ideally within 1 month of their clinically indicated imaging~     follow up appointment). In patients who undergo more frequent screening (generally 3 month~     intervals), SHAPE exams will be performed at 6 month intervals. Any repeat trans-jugular~     liver biopsies performed in this population will also trigger a repeat SHAPE study. Results~     of blood test evaluations (performed every 3 months in this population), medication,~     concomitant imaging study or procedure (including endoscopies) will be noted (all blood tests~     and imaging are clinically indicated only and are not required by this protocol). The end~     point for this part of the study will be any one new complication (e.g., liver cancer) or a~     marked worsening in any complication, liver transplantation, death, or the end of this~     clinical trial (after 3 years). The investigators expect these patients will be monitored~     three times during the course of this clinical trial. The time to reach the end point will be~     noted if a new complication or a marked worsening in any complication occurs.~   "
82351|NCT02489032|"~     The goal of the proposed research is to complete the development of a web-based program to~     train Employee Assistance Program (EAP) and EAP-affiliated managed behavioral health~     organization (MBHO) practitioners to conduct screening, brief intervention, and referral to~     treatment (SBIRT) for problem alcohol use among working adults.~   "
82352|NCT02489019|"~     Hypotension is frequently encountered after induction of general anesthesia. It can be~     pronounced in elderly patients and can require administration of vasopressor agents including~     ephedrine and phenylephrine. Intraoperative hypotension, especially prolonged episodes, can~     contribute to an increase in morbidity and mortality in the postoperative period as suggested~     by some former studies. The investigators hypothesize that fentanyl can contribute to the~     decrease in blood pressure (BP) that is seen after induction of general anesthesia in older~     patients. This hypotension may be due to fentanyl blocking effect on the sympathetic nervous~     system.~      This study will be the first one to examine the effect of fentanyl administration on blood~     pressure in elderly patients with induction of general anesthesia prior to the start of~     surgery. If the study shows that fentanyl contributes to hypotension during this period, it~     may lead to a change in practice and better patient outcomes and mortality rates.~   "
82353|NCT02489006|"~     This is a study that will look at the effects and how useful investigational drug olaparib is~     as a neoadjuvant treatment (treatment given as to shrink a tumor before the main treatment)~     prior to surgery in patients with recurrent ovarian, primary peritoneal or fallopian tube~     cancer.~   "
82354|NCT02488993|"~     This study evaluates hepatic encephalopathy (HE) and liver-related hospitalization rates and~     duration of stay in patients with HE treated with rifaximin-α 550mg compared to patients~     receiving other therapies.~      This registry study aims to comprehensively and rigorously characterize the impact of~     rifaximin-α 550 mg on hospitalization, clinical safety and effectiveness outcomes, and~     quality of life in patients with HE in Europe and Australasia.~   "
82355|NCT02488980|"~     This was a placebo controlled, randomised, double-blind, double-dummy study of the efficacy~     of weekly tafenoquine compared with weekly mefloquine or placebo in the chemosuppression of~     P. falciparum in Nyanza Province, western Kenya.~   "
82356|NCT02488967|"~     This randomized phase III trial studies how well doxorubicin hydrochloride and~     cyclophosphamide followed by paclitaxel with or without carboplatin work in treating patients~     with triple-negative breast cancer. Drugs used in chemotherapy, such as doxorubicin~     hydrochloride, cyclophosphamide, paclitaxel, and carboplatin, work in different ways to stop~     the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. It is not yet known whether doxorubicin hydrochloride and~     cyclophosphamide is more effective when followed by paclitaxel alone or paclitaxel and~     carboplatin in treating triple-negative breast cancer.~   "
82357|NCT02488954|"~     Ulcerative colitis (UC) is an immune mediated chronic inflammatory bowel disease that results~     at least in part of an abnormal immune response to environmental factors including the~     intestinal microbiota. Thus, use of probiotics (microorganisms that are believed to provide~     health benefits when consume) may restore the gastrointestinal microbiota and reduce~     intestinal inflammation.~      Propionibacterium freudenreichii is used for the production of fermented food products~     (cheese). Some selected strains have strong anti-inflammatory properties. Use of cheese based~     on a monoxenic culture of anti-inflammatory strain of Propionibacterium freudenreichii may~     decrease disease activity during ulcerative colitis.~   "
82358|NCT02488941|"~     Background: Non-alcoholic fatty liver disease (NAFLD) is the most common cause of chronic~     liver disease in the western world and an important cause of morbidity and mortality~     including risk of cardiovascular disease. A ruling dogma is that a fatty liver is~     well-functioning. Recent studies imply the contrary but quantitative measurements of~     metabolic liver function have not been systematically investigated in NAFLD.~      Objectives: To study and quantify specific metabolic liver functions in varying degrees of~     NAFLD. Furthermore to map the coagulation system of patients with NAFLD.~      Methods: A human clinical study. Metabolic liver functions are studied by a series of~     functional tests (Galactose elimination capacity (GEC), Aminopyrine breath test (ABT),~     Indocyanine green plasma disappearance rate (ICG-PDR), Functional hepatic nitrogen clearance~     (FHNC)). Regional liver function evaluated by 2-[18F]fluoro-2-deoxy-D-galactose (FDGal)~     PET/CT is compared to fat infiltration assessed by Magnetic resonance imaging (MRI). Primary~     and secondary hemostasis, natural anti-coagulants and fibrinolysis are evaluated.~      Perspectives: To challenge the dogma, that hepatic metabolic function is not affected in~     NAFLD, improving the understanding of the relationship between the clinical degree of NAFLD,~     histology, metabolic functions, and imaging. Furthermore to disclose a proposed procoagulant~     imbalance in NAFLD.~   "
82449|NCT02487745|"~     The purpose of this clinical trial is to evaluate the effectiveness and economic benefits of~     a Wage Supplement Model of arranging long-term exposure to employment-based abstinence~     reinforcement.~   "
83379|NCT02475616|"~     This is a single-center, placebo-controlled, randomized, double-blind, dose-escalation study~     to evaluate safety, tolerability, and PK of a single oral (PO) administration of PCO371 in~     healthy adult males.~      Caucasian and Japanese subjects will be randomized to receive either PCO371 or placebo.~   "
82363|NCT02488876|"~     The aim of this study is to collect non-individual related blood samples for the compelling~     of a unique database of tissue samples to understand the inflammatory responds after cardiac~     surgery on an on-going basis. This includes especially protein analyses and genetic testing~     for certain neurotransmitters in the blood and tissues to understand disease markers related~     to heart disease. The study is designed as an openly recruiting biobank with the purpose to~     later serve multiple study purposes. Outcomes refer to protein analyses and genetic testing~     for neurotransmitters in the blood and tissues.~   "
82364|NCT02488863|"~     Musculoskeletal pain represents the leading cause of disability worldwide. It has been~     traditionally attributed to peripheral mechanisms, but peripheral damage, inflammation, and~     psychological factors have failed to significantly account for the presence, absence, or~     severity of chronic musculoskeletal pain (CMP). Recent studies show that individuals with CMP~     exhibit dysfunctional pain modulation supporting a significant central nervous system (CNS)~     contribution. However, the CNS mechanisms underlying these changes in pain modulation are not~     currently known, nor is their relation to clinical pain progression. The proposed pilot~     examines brain circuits recently described in predicting the transition from acute to chronic~     pain, in predicting clinical and experimental pain changes as well as physical performance~     and mobility changes in older persons with musculoskeletal pain over a one year period. The~     findings will provide novel and important information regarding the mechanisms underlying~     aberrant pain processing and its functional consequences in older adults with musculoskeletal~     pain. The information learned can be subsequently used to target treatment and prevention~     strategies in future studies of older adults. The central hypothesis is that increased~     functional and structural connectivity of cortico-striatal regions will be significantly~     associated with baseline clinical and experimental pain and decreased physical function in~     persons with CMP and will account for more rapid clinical pain and disability progression~     over time.~   "
82365|NCT02488850|"~     Rationale: An anatomical surgical resection is considered to be the standard of care in fit~     patients who present with early stage non-small cell lung cancer (NSCLC). However, surgery is~     less frequently performed in both elderly patients (aged ≥75 years), who represent the~     fastest-growing group of patients with stage I/II NSCLC, and in patients who have significant~     co-morbidity. Following the introduction of stereotactic ablative radiotherapy (SABR), an~     outpatient treatment that is typically delivered in between 3-8 fractions, the median~     survival of all elderly patients undergoing radiotherapy in The Netherlands increased by 9.3~     months. Randomized trials comparing SABR and surgery have yet to be completed and results of~     the ongoing ACOSOG Z4032 studies will not be available in the within 5 years. A recent data~     retrospective study comparing both modalities has raised interesting questions about the~     impact of local therapy on recurrence patterns. It was found that a better loco-regional~     disease control rate was achieved with SABR.~      Objective: To study the effect of surgery and SABR on both immunostimulatory (with primary~     endpoint CD8 positive cells) and immunosuppressive cells in peripheral blood in patients with~     early stage non-small cell lung cancer who are treated with either modality.~      Study population: 40 patients with cT1-2aN0M0 either cytologically or histologically proven~     NSCLC.~      Main study parameters/endpoints: To determine whether an increase in CD8 activity can be~     established after SABR in patients with early stage lung cancer and to compare this increase~     with that in patients undergoing a surgical intervention. Nature and extent of the burden and~     risks associated with participation, benefit and group relatedness: Only risks in~     participation are the risks with drawing blood. Subjects will not have any benefits. This~     pilot study will be used to generate information concerning both treatments useful for the~     decision to plan a future study in a larger series of patients.~   "
82366|NCT02488837|"~     The purpose of the study is to determine if non-invasive measurements of brain waves from the~     skin called electroencephalography (EEG) can predict whether the brain stimulator will help~     your symptoms. Our goal is to obtain these brain wave measurements with patients both awake~     and under general anesthesia, and then to evaluate which brain wave patterns are associated~     with clinical improvement to determine if they could be useful for predicting whether the~     surgery will work. If such predictive measures were established based upon the findings of~     this study, they could be used in the future to improve surgical outcomes in the following~     ways: (1) to help guide surgical targeting in the operating room awake or under anesthesia,~     (2) to guide post-operative programming in clinic, and (3) and to develop potential feedback~     systems for automatic programming of the brain stimulator system at home.~   "
82367|NCT02488824|"~     The ability to maintain normal body temperature (Tcore) is impaired in persons with~     tetraplegia: subnormal Tcore and vulnerability to hypothermia (<95 F) have been documented in~     this population after exposure to even mild environmental temperatures. However, no work to~     date has addressed the effect of subnormal Tcore on cognitive performance in persons with~     tetraplegia despite studies with able-bodied (AB) individuals that have documented~     progressive decline in various aspects of cognitive performance associated with the magnitude~     of the depression in Tcore. The investigators' study will confirm and extend their initial~     observations in persons with higher cord lesions who have subnormal Tcore to show that~     cognitive performance will be improved by raising Tcore to euthermic levels. This improvement~     should be associated with greater function and independence, reintegration into society, and~     an improved quality of life.~      Specific Aims: During exposure to 95 F for up to 120 minutes in the seated position, the~     investigators' aims are:~      Primary Specific Aim: To determine if a modest rise in Tcore to euthermic levels has a~     positive effect on cognitive performance (attention, working memory, processing speed, and~     executive function) in persons with higher-level spinal cord injury (SCI).~      Primary Hypothesis: Based on the investigators' pilot data: (1) 80% of persons with SCI will~     demonstrate an increase of 1 F in Tcore, while none of the AB controls will demonstrate such~     an increase; (2) 80% of persons with SCI will have an improvement of at least one T-score in~     Stroop Interference scores (a validated measure of executive function), while none of the AB~     controls will demonstrate a change in cognitive performance.~      Secondary Specific Aim: To determine changes in: (1) The average of distal skin temperatures;~     (2) Sweat rate; and (3) Subjective rating of thermal sensitivity.~      Secondary Hypothesis: Persons with SCI will have less of a percent change in average distal~     skin temperatures and sweat rate, and will report blunted ratings of thermal sensitivity~     compared to that of AB controls.~   "
82368|NCT02488798|"~     100 patients with postmenopausal bleeding were assessed with 2D vaginal ultrasound and 3D~     power Doppler ultrasound using the international endometrial tumor analysis group and office~     hysteroscopy with taking samples for histopathological analysis.~   "
82369|NCT02488785|"~     The goal of this study is to evaluate the impact of a comprehensive diabetes education and~     management program based on frequent communication with patients using teleconsultation, text~     messaging, and phone calls on diabetes related outcomes in Latino patients with type 2~     diabetes. The investigators hypothesize that the decline in hemoglobin A1c value between the~     baseline and the six-month visit will be at least 0.5 percent greater in the intervention~     group than in the control group.~   "
82388|NCT02488538|"~     Three hundred women with severe premenstrual syndrome will be divided into 3 groups using~     computer generated random numbers. Group 1 will receive COC containing drospirenone~     (drospirenone 3mg+Ethinylestradiol 0.03mg; Yasmin® ScheringAG, Egypt) daily for 21 days~     starting from the 3rd day of menstruation in addition to oral fluoxetine 20 mg daily. Group 2~     will receive COC containing drospirenone daily for 21 days starting from the 3rd day of~     menstruation in addition to a daily oral placebo similar in size, color and structure to~     fluoxetine . Group 3 will receive oral placebo similar to COC daily for 21 days starting from~     the 3rd day of menstruation in addition to a daily oral placebo similar in size, color and~     structure to fluoxetine.~   "
82370|NCT02488772|"~     Background The emergency department is a chaotic place with high levels of noise and light 24~     hours a day. Patients are often boarded overnight while they await tests or consultations~     scheduled for the morning. Sleep deprivation, high noise levels have been associated with~     negative patient experiences and outcomes in other clinical settings. Interventions to~     counter the effects of noise and light in the emergency department for patients staying~     overnight have not been investigated.~      Objective To determine if sleep and other aspects of the patient experience can be improved~     for patients boarded overnight in the Emergency Department with the use of a sleep mask and~     ear plugs.~      Methods A randomized control study will take place in the Emergency Department of Kingston~     General Hospital. Eligible patients will randomized to receive either sleep aids (sleep mask~     and ear plugs) or standard treatment (no sleep aids). The primary outcome will be sleep~     quality, assessed by Richards-Campbell Sleep Questionnaire. Secondary outcomes include~     patient satisfaction, hours of sleep, blood pressure, heart rate, new-onset delirium,~     patient's sense of feeling well-rested and patient overall sense of well-being. The primary~     analysis will be intention-to-treat comparing primary and secondary outcomes between the two~     groups in an unadjusted fashion. A secondary analysis will involve linear regression to~     explore the association between treatment group and Richards-Campbell Sleep Score,~     controlling for potential confounders.~      Importance Determining the feasibility and efficacy of sleep masks and earplugs for patients~     in the emergency department to improve sleep and the patient experience has never been done~     before. If found to be effective, this relatively low- cost intervention could be implemented~     in emergency departments across the country and around the world.~   "
82371|NCT02488759|"~     The purpose of this study to investigate the safety and effectiveness of Nivolumab, and~     Nivolumab combination therapy, to treat patients who have virus-associated tumors. Certain~     viruses have been known to play a role in tumor formation and growth. This study will~     investigate the effects of the study drugs, in patients who have the following types of~     tumors:~        -  Anal canal cancer~        -  Cervical cancer~        -  Epstein Barr Virus (EBV) positive gastric cancer~        -  HPV positive and negative squamous cell cancer of the head and neck (SCCHN)~        -  Merkel Cell Cancer~        -  Nasopharyngeal cancer (NPC)~        -  Penile cancer~        -  Vaginal and vulvar cancer~   "
82372|NCT02488746|"~     Prospective observational trial. A full thickness resection of gastric subepithelial tumors~     is performed after application of full thickness sutures underneath the tumor with the~     GERDX(TM) device. Hypothesis: This endoscopic method is feasible, effective and safe.~   "
82373|NCT02488733|"~     Bariatric surgery is efficient in both inducing adequate weight loss and the control of~     glycemia in obese patients affected by Type 2 Diabetes Mellitus (T2DM).~      Despite growing evidence suggesting that early performance of bariatric surgery on obese~     patients with T2DM offers the best opportunity to reach and maintain a remission of diabetes,~     no randomized clinical trials (RCT) have evaluated its efficiency in patients with new T2DM~     diagnosis.~      The aim of this RCT is to compare bariatric surgery, and in particular Laparoscopic Sleeve~     Gastrectomy (LSG), with conventional medical therapy (CMT) in patients with new T2DM~     diagnosis that are obese (Body Mass Index, BMI of between 30 and 42 Kg/m2), to be recruited~     at two Italian diabetology centres (Terni and Rome).~      The main objective of the present RCT is to investigate the efficacy of LSG as compared with~     CMT in inducing and maintaining both a resolution of T2DM (defined as HbA1c levels ≤6.0%,~     without active pharmacologic therapy or ongoing procedures) and the remission of T2DM through~     the evaluation of the criteria provided by the American Diabetes Association (ADA) at maximum~     follow-up of 6 years. The effects of the two treatments in terms of weight loss and the~     quality of life of the patient will also be taken into consideration.~      Any positive results of this study will include preventing microvascular and macrovascular~     complications connected with diabetes, without the necessity to take medication, and at the~     same time the loss of excess body weight and improved quality of life (QOL).~   "
82374|NCT02488720|"~     The LEARN study a multicenter, observational study will that will evaluate the rate of~     cognitive change in approximately 500 clinically normal older individuals who screen-fail~     for the A4 trial on the basis of their screening PET imaging not demonstrating evidence of~     elevated amyloid accumulation (Aβ negative) but meet all other A4 study eligibility criteria.~     This study will leverage the A4 infrastructure and maximize the data acquired in screening a~     large number of well-characterized older adults for the A4 trial.~      The LEARN observational cohort will provide a critical comparison group for the A4 placebo~     arm, and future trials in preclinical AD. Although accumulating longitudinal data suggest~     that older individuals with elevated Aβ burden are at increased risk of cognitive decline, it~     is important to demonstrate a differential rate of clinical decline between Aβe (Aβ~     elevated) and Aβne (Aβ not elevated) individuals on a standardized set of clinical~     outcomes. Over 2000 well-characterized, highly motivated older volunteers will screen fail~     for the A4 trial. The LEARN study will follow 500 of these individuals, matched as closely as~     possible to the two treatment arms, in this observation cohort. The LEARN study may~     selectively recruit from a specific range of SUVr that fall below the threshold for elevated~     amyloid in order to support analyses of the relationship of baseline SUVr to subsequent~     cognitive change and amyloid accumulation. The observational cohort will be followed for 168~     weeks with identical clinical/cognitive testing performed every 24 weeks, running parallel to~     the A4 treatment study.~   "
82375|NCT02488707|"~     A prospective study is planned for management of low rectal cancer with the aim of sphincter~     preservation and improving the oncological outcome of the patients, through comparing of both~     approaches minimally invasive techniques including transanal total mesorectal excision and~     laparoscopic intersphincteric resection.~   "
82376|NCT02488694|"~     This study aims to compare the efficacy of afatinib maintenance with pemetrexed maintenance~     following induction therapy with platinum/ pemetrexed in patients with metastatic epidermal~     growth factor receptor (EGFR) mutated non-small-cell lung cancer (NSCLC) progressing after~     first-line treatment with afatinib with respect to progression-free survival.~   "
82377|NCT02488681|"~     Medtronic is sponsoring the Micra Continued Access (CA) study to provide continued access to~     the Micra System while the marketing application is under review by the Food and Drug~     Administration (FDA).~   "
82389|NCT02488525|"~     Main objective of the study is to demonstrate that a prophylactic treatment with VWF factor~     concentrate after implantation of continuous-flow left ventricular assist device (CF-LVAD)~     reduces the frequency of clinically significant bleeding within 3 months after implantation~     in comparison to the usual care. Adult patients with functional defects of VWF measured after~     implantation of continuous LVAD are randomly assigned to prophylactic treatment.~   "
82450|NCT02487732|"~     To investigate pleiotropic effects of ticagrelor in addition to its antiplatelet effects in~     type 2 diabetic patients with non-ST elevation acute coronary syndrome by measuring~     inflammatory markers, circulating number of endothelial progenitor cells, brachial artery~     endothelial function, and arterial stiffness.~   "
82378|NCT02488668|"~     Phantom limb pain (PLP) is a frequent consequence of amputation, and it is notoriously~     difficult to treat. Amputation usually follows traumatic injuries or surgery following~     vascular diseases, diabetes, osteomyelitis or tumours in cases where the loss of the limb is~     required for the survival of the patient. The loss of a limb or other body parts is usually~     followed by the sensation that the lost body part is still present and can be felt. These~     phenomena are called, respectively, phantom awareness and phantom sensation. In 50-80% of~     amputees neuropathic pain develops in the lost limb also referred to as phantom limb pain~     (PLP). PLP can be related to a certain position or movement of the phantom limb, and might be~     elicited or worsened by a range of physical factors (e.g. changes in the weather or pressure~     on the residual limb) and psychological factors (e.g. emotional stress). It is well known~     that most treatments available for PLP today, such as pharmacological, surgical, anaesthetic,~     psychological and other, are ineffective.~      Today it is believed that phantom limb pain may be related to changes in the cortex of the~     brain. There is evidence that these changes may be modulated - or even reversed - by~     providing sensory input to the stump or amputation zone. For example, cortical reorganization~     and alleviation of phantom limb pain has been observed in amputees following intense use of a~     hand prosthesis. However, there is no consistent knowledge on which type of peripheral~     sensory feedback may be effective in affecting the cortical plasticity or on how to best~     apply the sensory feedback.~      The aim of the proposed research is to create natural, meaningful sensations through~     providing non-invasive sensory feedback (i.e. surface electrical stimulation) and the~     effectiveness to alleviate phantom limb pain and restore the cortical neuroplastic changes.~   "
82379|NCT02488655|"~     This study evaluates the efficacy of the HIFU for the treatment of breast fibroadenoma with~     the FastScan version using assessment of patient experience and adverse event reporting.~   "
82380|NCT02488642|"~     The purpose of this study is to assess the therapeutic efficacy and safety of isosorbide~     dinitrate-oxytocin in combination in the management of late intrauterine foetal death.~   "
82381|NCT02488629|"~     To evaluate the safety and efficacy of SCB01A in head and neck cancer.~   "
82382|NCT02488616|"~     Closed-loop strategy is composed of three components: glucose sensor to read glucose levels,~     insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required~     insulin dosages based on the sensor's readings.~      The main objective of this project is to compare the efficacy of single-hormone closed-loop~     strategy and sensor-augmented pump therapy to regulate glucose levels in outpatient settings~     for 5 consecutive days in adults with type 1 diabetes.~      The investigators hypothesized that single-hormone closed-loop strategy will increase the~     time spent in the target range compared to sensor-augmented pump therapy.~   "
82383|NCT02488603|"~     This is an educational intervention study for breast cancer patients who undergo tamoxifen~     treatment. The purpose of the study is to assess the impact of decision aids (DA) on the~     patients' decision-making process, compliance on drug, and knowledge regarding tamoxifen~     treatment. Patients will randomly assign to DA group or conventional group. Both groups will~     have baseline questionnaire surveys before starting tamoxifen treatment, and 4 weeks later~     follow-up questionnaire surveys.~   "
82384|NCT02488590|"~     The differential diagnosis of asthma and COPD is sometimes difficult. Recently, an overlap~     syndrome has been defined based on the concurrence of asthma and COPD characteristics. These~     characteristics are based on expert opinions and have never been investigated nor validated~     prospectively.~      The investigators assume that the management strategy, the symptom burden and disease~     progression will differ between asthma, COPD and ACOS. Therefore, the study wants to~     establish baseline criteria for an appropriate disease definition and evaluate the potential~     impact on treatment and symptom control.~   "
82385|NCT02488577|"~     Cases with stage T2 N0 low rectal cancer will undergo either Transanal minimally invasive~     total mesorectal excision or transanal minimally invasive locoregional resection.~   "
82386|NCT02488564|"~     It is a multicenter, open-label, two stage phase II trial, to assess activity, safety and~     potential early predictors of response in neoadjuvant setting. Patients with operable breast~     cancer (T1c and cytologically N1-2, or cT2-3, N0-N2, M0) or locally advanced breast cancer~     (T4a-d, N0-N2, M0) with overexpression or amplification of HER2 (AJCC 7th edition 2010) are~     included in the study.~      The primary objective is to evaluate the pathological complete response rate (pCR).~      The secondary objectives are:~        -  to evaluate the clinical response rate (RR).~        -  to evaluate the feasibility and systemic tolerance, with particular attention to cardiac~          toxicity.~        -  to evaluate the conservative surgery rate.~      Total duration of the trial is 36 months; planned treatment are 6 cycles of chemotherapy. At~     every cycle (every 21 days) will be administered:~      Day 1: Liposome-encapsulated doxorubicin, 50 mg/m2 IV 1 hour infusion; Day 2 and 9:~     Docetaxel, 30 mg/m2 IV 1 hour infusion; Day 2, 9 and 16: Trastuzumab 4 mg/kg for the first~     infusion loading dose, then 2 mg/kg/week for subsequent injections. Day -13 to 0: Metformin~     is administered as single agent. From day -13 to day -11, Metformin 1000 mg will be~     administered once a day; from day -10 Metformin 1000 mg will be administered twice a day~     continuously until end of the study treatment.~   "
82387|NCT02488551|"~     Background and Significance: Randomized Controlled Trials (RTCs) have demonstrated that~     evidence-based psychotherapies (EBPs), particularly Cognitive Behavioral Therapy (CBT), are~     highly effective in treating anxiety and depression, the most common mental health disorders~     in primary care settings. Mental health (MH) providers in VA~     Community-Based-Out-Patient-Clinics (CBOCs) are often located in rural areas and isolated~     from educational opportunities. Almost half of Veterans now use CBOCs. Studies have shown~     that the quality of delivery of EBPs (fidelity) impacts clinical outcomes. This study will~     test a computer-assisted tool (CALM Tools for Living) that increases fidelity to CBT in~     treating depression and four common anxiety disorders, including PTSD. Although results of a~     large RCT, the CALM study, suggested that the tool contributed to fidelity to the CBT~     protocol, this hypothesis has not been tested. This study will test the tool in primarily~     rural CBOCs in VA VISN16.~      Objective: To modify a computer-assisted CBT tool to meet the needs of CBOC MH providers and~     Veterans, to evaluate the impact on providers' fidelity to the CBT model and clinical~     outcomes, and to assess how best to support future implementation.~      Specific Aims/Hypothesis: (1) Engage CBOC MH providers in modifying the computer-assisted CBT~     tool such that its content is relevant and acceptable to Veterans and providers. The~     investigators hypothesize that the modified tool will be acceptable to both Veterans and~     providers. (2) Compare MH provider fidelity to CBT and clinical outcomes among providers who~     used the tool and those who did not. The investigators hypothesize that clinicians who use~     the tool will have a higher fidelity to CBT and clinical outcomes among patients will be~     superior. (3) Prepare for future implementation of the tool in the VA.~      Methodology: This study will use a Type III hybrid effectiveness design. Methods common to~     the field of Instructional Design and Technology (IDT) will be used to modify the tool.~     Thirty-four CBOC MH providers will be trained in CBT and randomized to use the tool or not.~     Both groups will receive external facilitation to encourage the full implementation of CBT~     into practice on the clinic level. MH providers will treat 10 patients each. Patients will be~     assessed at baseline, 3, 6, and 12 months. Provider fidelity to the CBT protocol will be~     measured, and finally, a tool kit for future implementation of the tool will be disseminated.~      Impact: The investigators expect the intervention to improve the technical quality of MH~     treatment in CBOCs and improve clinical outcomes among Veterans.~   "
82412|NCT02488226|"~     This project seeks to understand how the gaze behavior of infants and children with or at~     high risk for autism spectrum disorder (ASD) may be manipulated in the contexts of dynamic~     social and non-social scenes. The study explores not only the methods which may be most~     effective in aligning and teaching normative patterns of scene exploration, but also seeks to~     establish what behavioral characteristics may be most predictive of atypical scanning and~     atypical learning.~   "
82390|NCT02488512|"~     This is a prospective, single arm,single centre open-label, phase II study in relapsed or~     refractory DLBCL and MCL non-Hodgkin's lymphoma (NHL), not suitable to other therapies,~     included HDCT, or patients relapsed after high-dose chemotherapy (HDCT) with autologous~     stem-cell transplantation (ASCT), treated with peptide receptor radionuclide therapy with~     90Y-Dotatoc.~      Each patient will receive a maximum cumulative 90Y-DOTATOC activity of 11.1 GBq (300 mCi),~     divided into 4 cycles (1.8 - 2.8 gigabequerel (GBq) for each cycle) with an interval of 6 - 8~     weeks between cycles. The 90Y-DOTATOC will be slowly infused intravenously.~      35 patients will be enrolled in 36 months in two stages (18 patients in the first stage, if 2~     or fewer patients will show an objective response, the study will be closed).~   "
82391|NCT02488499|"~     This study investigates the effectiveness of a clinic-adapted version of the Coping Power~     program compared to individualized child and family treatment for children with disruptive~     behaviour and their parents.~   "
82392|NCT02488486|"~     This pilot study evaluates the effectiveness of a closed-loop administration of propofol and~     remifentanil guided by the bispectral index for short-term sedation after cardiac surgery.~   "
82393|NCT02488473|"~     Brief Summary: The aim of this trial is to investigate if dexmedetomidine prolongs the~     duration of an adductor canal block. By using healthy volunteers the investigators can~     perform a bilateral adductor canal block and thereby control for a systemic effect to clarify~     if the effect is actually peripheral or systemic. The investigators hypothesis is that~     dexmedetomidine as an adjunct to a local anaesthetic prolongs the duration of a peripheral~     nerve block by a peripheral mechanism.~   "
82394|NCT02488460|"~     Background~      Increased physical activity can improve cognition and academic skills. However due to~     economic concerns and increasing focus on standardized testing, PA in schools often receives~     little attention and physical education is reduced in many countries in favor of spending~     more time devoted to academic classes. This tendency is not compatible with the increasing~     evidence for the association between physical activity, fitness, cognitive and academic~     performance.~      Despite increasing evidence for the association between PA, fitness, cognitive and academic~     performance, very few longitudinal high-quality studies exists examining the effect of~     physical activity on academic performance (ref.). Furthermore, to the best of our knowledge~     only two studies have assessed academic outcomes following the integration of physical~     activity into the classroom with intervention participants scoring significantly higher in~     test sections compared to controls which makes generalizing from these results challenging.~      To promote policy changes that require more physical activity in school, empirical data are~     needed to study the effects of school-based physical activity programs. Therefore the~     investigators carried out a cluster randomized controlled trial conducted to examine the~     effect on math achievement and executive functions of classroom based PA in math.~   "
82395|NCT02488447|"~     The purpose of ths study is to evaluate changes in life quality of patients affected by~     rhinoconjuntivitis with or without asthma after immunotherapy treatment. It is an~     observational, prospective and comparative study before-after immunotherapy treatment with a~     one year follow-up.~   "
82396|NCT02488434|"~     The aim of the current study is to evaluate to effectiveness of sperm selection by using~     fertile chip in unexplained infertile couples on intracytoplasmic sperm injection (ICSI)~     cycles.~   "
82397|NCT02488421|"~     The purpose of this study is to determine and compare the persistence rate of newly~     prescribed apixaban, rivaroxaban, dabigatran and VKAs in patients with NVAF.~   "
82398|NCT02488408|"~     A Phase Ib/II multicentre open label study of BGb324 as a single agent in patients with AML~     or MDS or in a combination with cytarabine and decitabine in AML patients.~      BGB324 is a potent selective small molecule inhibitor of Axl, a surface membrane protein~     kinase receptor which is overexpressed in up to half of AML cases.~   "
82399|NCT02488395|"~     The ultimate goal of this project is to evaluate a possible new strategy to diagnose earlier~     Parkinson's disease, using the superior colliculus as a biomarker.~      Preliminary data from the investigator's group in a rat model of Parkinson's disease suggest~     that the superior colliculus, a sensory structure, show an early deficit in visual~     processing. The investigator's data also suggests that with the evolution of the disease,~     this structure presents a neuronal re-organisation leading which causes a sensory rebound~     after the introduction of the treatment. The light responses in the superior colliculus were~     faster, bigger in amplitude and lasted longer (Rolland et al., 2012). Those results raise an~     important question about the superior colliculus functional state in Parkinson's patients. If~     this structure have a similar neuroplasticity, the investigators could hypothesize that the~     superior colliculus may also present a sensory rebound when introducing the treatment. If~     this hypothesis is true, the accelerated and amplified light responses of this structure may~     explain the difficulties felt by the patients to inhibit reflexive saccades induced by the~     appearance of unexpected visual stimuli. Indeed, the superior colliculus is involved in the~     orientation of the head and eye toward any sudden changes in our environment (Wurtz and~     Albano, 1980) and the light responses of this structure are strongly correlated with the~     speed of the saccade (Marino et al., 2012).~      Therefore, the investigators want to test if a similar deficit could be observed in the~     superior colliculus of newly diagnosed PD patients. Data will be compared to matching~     controls.~   "
82400|NCT02488382|"~     The aim of this study is to evaluate the efficacy and tolerability of Lonquek which is a~     pegylated (long-acting) version of Filgrastim recombinant human G-CSF (G-CSF) in mobilizing~     sufficient number of stem cells for autologous stem cell transplantation in patients with~     lymphoma and multiple myeloma.~   "
82413|NCT02488213|"~     Randomized clinical trial with outpatient patients with type 2 diabetes mellitus treated in~     Endocrinology Division, Hospital de Clinicas de Porto Alegre. The study aims to carry out a~     nutritional counseling directed to offer benefits in metabolic control in diabetic patients.~   "
82414|NCT02488200|"~     The present study plans to delineate the clinical, biochemical, sociological and~     psychological factors. involved in dialysis preparation, and their impact on dialysis~     initiation (DI), modality choice and prognosis. In particular the following questions are to~     be answered.~        1. What factors influence unplanned DI?~        2. What factors influence choice of dialysis modality?~        3. What factors influence choice of dialysis access?~        4. Why do physicians start dialysis?~        5. What factors in the predialytic period and its immediate aftermath (the peridialytic~          period) influence prognosis?~   "
82401|NCT02488369|"~     This is a diagnostic prospective multicenter study. This study will be conducted in 32~     centers of the Société Française des Cancers et Leucémies de l'Enfants et de l'Adolescent~     (SCFE) in patients with non-Hodgkin lymphoma and treated according to recommendations of the~     SFCE for each type of non-Hodgkin lymphoma. All patients will have a PET / CT associated with~     conventional imaging time of remission assessment. Histological examination of residual tumor~     will be conducted whenever practicable in patients with pathologic residual image on~     conventional imaging and / or PET / CT. A central review of conventional imaging examinations~     and PET / CT will be performed independently from each other.~      Moreover, whenever possible, patients will have a PET / CT at diagnosis and an early PET / CT~     (between J8 and J28 according to the type of lymphoma and toxicities due to treatment). The~     results of the early PET / CT should not lead to treatment modifications.~      In case of residual tumor at remission assessment, therapeutics changes as recommended~     therapeutic protocols will be based on histologic findings and not on the results of PET / CT~     alone.~   "
82402|NCT02488356|"~     Safety and Efficacy of Litramine in weight loss.~   "
82403|NCT02488343|"~     Adherence is an active process wherein the patient acts in collaboration with the medical and~     paramedical staff in order to improve his/her health. Adherence to medication comprises of~     implementation and persistence and it is estimated to be around 50% in various chronic~     illnesses, including Multiple Sclerosis (MS). MS patients who fail to properly adhere to~     their DMTs regimen may be at increased risk for the development of new central nervous system~     lesions, exacerbations, increased disabilities and poorer quality of life. Plausible reasons~     for the low adherence rates in MS mentioned in the literature include patients' attributes,~     condition attributes and therapy related factors.~      The objective of this study is to develop a personal profile of adherence based in the~     factors mentioned above. In the first part of the study patients will be followed up and the~     profile My Multiple Sclerosis Perception Adherence Scoring System (MyMS_PASS) will be created~     and tested. In the second part, patients with non-optimal rates of adherence will receive~     tailored intervention in order to improve therapy to treatment. This work may serve as a~     model for the study of adherence to therapy and the development of interventions in MS as~     well as in other chronic diseases.~   "
82404|NCT02488330|"~     This extension study will provide continued onartuzumab and/or parent trial (P-trial)~     designated control treatments to participants with cancer who were previously enrolled in a~     company-sponsored onartuzumab P-trial and who derived benefit, as assessed by the responsible~     investigator, from the therapy administered in the P-trial. The study will also collect~     safety data with regard to administration of continued onartuzumab therapy.~   "
82405|NCT02488317|"~     Empowering Patients On Choices for Renal Replacement Therapy (EPOCH-RRT) study seeks to~     identify factors that matter the most to patients with kidney disease and study how they are~     impacted by different types of dialysis. The inclusion of patients, caregivers, and patient~     advocacy organizations as research partners will assure that the study addresses questions of~     greatest relevance to patients facing the need for dialysis.~      For Aim 3, the investigators are going to compare measures related to the decision-making~     process between patients receiving and not receiving a decision aid focusing on Peritoneal~     Dialysis and Hemodialysis.~   "
82406|NCT02488304|"~     The objective of this study is to detect BOS in an early stage by using the outcome~     parameters generated by Functional Respiratory Imaging (FRI). Robust and automated~     segmentation algorithms will be developed for these parameters, focusing on quantitative~     computed tomography (CT) image analyses to provide the physician a more sensitive diagnostics~     tool. The evolution of rejection over time will be monitored using non-rigid image~     registration methods.~   "
82407|NCT02488291|"~     The investigators study the efficacy of epidural sufentanil/ropivacaine for analgesia labor~     in primiparas so as to decrease perinatal complications of analgesia labor.~   "
82408|NCT02488278|"~     The GlucoMe device, in its original packaging, along with the user manual and QuickStart~     guide will be provided to the patient in a simulated home use environment. The patient~     labeling will be in the format intended for distribution.~      Ten (10) subjects identified as potential end users of the GlucoMe device will receive the~     user manual. An additional ten (10) subjects also identified as potential end users of the~     GlucoMe device will NOT receive the user manual. All subjects will be provided with a~     pre-test and post-test questionnaire and a list of tasks to complete, including applying and~     operating the device.~      The observer and user post-test questionnaire will collect information regarding device use.~     The device's use will be compared with identified risks to determine if the percentage of~     failures is within the study protocol success criteria. Additionally, measurable usability~     criteria for specific, critical steps will be evaluated.~   "
82409|NCT02488265|"~     Postural instability is a particularly incapacitating disorder, where loss of motor~     independence by Parkinson´s Disease (PD) patients marks a significant stage of disease onset.~     Evidence suggests that deficits in automatic motor control, sensory integration and attention~     are associated with lack of balance in PD. Physiotherapy, together with medication, plays an~     important role in the treatment of this state, although no consensus has been reached on the~     best treatment modality. The aim of this randomized controlled trial protocol is to evaluate~     the effects of balance training with rhythmical (BRT), which is a motor program to improve~     balance associated with rhythmical auditory cues (RACs)~   "
82410|NCT02488252|"~     This study aims to explore the effect of an adjuvant semi-individualized Chinese medicine~     treatment plan on type 2 diabetic patients with stages 2 to 3 chronic kidney disease and~     macroalbuminuria. This study will collect preliminary data on treatment effect, variance,~     recruitment rate and attrition rate for the planning of a subsequent clinical trial.~   "
82411|NCT02488239|"~     The objective of this Post Market Clinical Follow-up (PMCF) is to collect data on the~     performance of the Ingenio 2 CRT-P devices and to document that device-related events, device~     malfunctions or device deficiencies (DDs) do not increase safety risks in Ingenio 2 CRT-P~     devices (CRT-Ps), both in general and specific to the new features and hardware of the~     devices.~   "
82415|NCT02488187|"~     Comparison of Preoperative Automated Breast Ultrasound (ABUS) and magnetic resonance imaging~     (MRI) in Newly Diagnosed Breast Cancer Patients.~   "
83380|NCT02475603|"~     Clinical, Biochemical and Neurophysiological Consequences of Intraoperative Tourniquet During~     Total Knee Arthroplasty:~      WOMAC-Score Knee-Score Radiographic Evaluations and Scoring System Biochemical muscle biopsy~     analysis~   "
82416|NCT02488174|"~     Severe acute respiratory failure (ARF) requiring prolonged mechanical ventilation is the most~     common form of acute organ dysfunction in the hospital, and is often associated with multiple~     organ failure (MOF), high mortality, and functional impairment. Most studies on ARF have~     focused on patients in the intensive care unit (ICU) after they have been on mechanical~     ventilation for days and end organ damage is already established. The overall goal of this~     proposed project is to improve the outcomes of patients at high risk for developing severe~     ARF and prolonged mechanical ventilation in and outside of the ICU. The project aims to~     intervene early in high risk patients with an electronic medical records (EMR)-based,~     patient-centered checklist of common critical care practices aimed at preventing lung injury~     and hospital acquired adverse events that commonly lead to organ failure (Prevention of Organ~     Failure checklist -PROOFcheck). This application proposes a stepped-wedge, clustered~     randomized control trial to determine the utility of PROOFcheck to improve survival and~     reduce the duration of mechanical ventilation and multiple organ failure in patients~     identified as high risk for progressing to severe ARF and prolonged mechanical ventilation.~     The aims in the UH2 phase are: 1) to refine a previously validated Lung Injury Prediction~     Score into a pragmatic, EMR-based early prediction model to Accurately Predict Prolonged~     Ventilation (APPROVE), which will automatically identify patients anywhere in the hospital~     who are at high risk for developing severe ARF requiring mechanical ventilation >48 hours; 2)~     to incorporate PROOFcheck into the EMR to prompt clinicians on care practices to limit lung~     injury, prevent adverse events, and avoid additional organ failure; and 3) to establish the~     infrastructure for the proposed trial. The proposed pragmatic trial will harness the~     hospital-wide EMR to identify patients at high risk for prolonged mechanical ventilation with~     APPROVE for intervention with PROOFcheck. As such, the proposed trial aims to break out of~     the clinical silos by which care is currently organized in the hospital and bring~     patient-centered, context appropriate care to the acutely ill patient wherever and whenever~     the patient's condition requires it.~   "
82417|NCT02488161|"~     Coordinated multi-center project with several complementary goals in each one of the~     sub-projects included. Objectives: 1.To determine risk factors of death, or major~     complications in the short term; 2.To determine risk factors of death, tumor recurrence,~     major complications, readmission or deterioration of quality of life in the mid term;~     3.Evaluation of patient reported outcomes from before the intervention to the end of the~     follow-up. 4.To study the role of immunohisto-chemistry markers in the prediction of similar~     adverse results. This sub-project (coordinator) will approach the determination of risk~     factors of death, tumor recurrence, major complications, readmission and deterioration of~     quality of medium term life (1-2 years). Methodology. Design: prospective cohort study with 2~     years follow-up after the surgical intervention. Participant centers: 18 hospitals of 6~     Autonomous Communities of all Spain. Patients diagnosed of colorectal cancer surgically~     intervened. Variables: pre-intervention, those of the hospital admission, sociodemographic,~     immunohisto-chemistry and clinical parameters, that could be in relation to the outcomes to~     study. Statistic analysis: a derivation sample will be created where the possible predicting~     parameters will be identified, by cancer of colon or rectum. Predictive models will be~     created with a good discriminative capacity. A validation of those models will be performed~     in a validation sub-sample. Logistic and Cox regression models will be used. Simulation~     models for the prediction of discreet events in the long term will be used.~   "
82418|NCT02488148|"~     Arterial stiffening and endothelial dysfunction are correlates of advancing age contributing~     to the decline in cardioprotection with age. Arterial stiffness and endothelial dysfunction~     are emerging risk factors for cardiovascular disease and predict future cardiac events.~     Vascular function has long been a target for lifestyle interventions with several studies~     showing improvements traditional exercise modes. However, the impact of yoga on vascular~     function remains elusive. This study will determine the effect of a 12-week Bikram yoga~     intervention on arterial stiffness and endothelial function in healthy, middle-aged adults.~      The overall aim of this study is to determine the efficacy of Bikram yoga in improving~     vascular endothelial function and arterial distensibility in middle-aged adults with risk~     factors for coronary artery disease and to determine whether the heated environment plays a~     role in mediating these alterations in vascular function. The investigators propose to~     conduct a 12-week Bikram yoga intervention study in sedentary individuals in order to test~     the following hypotheses:~        1. Bikram yoga will elicit reductions in arterial stiffness and enhancements in endothelial~          function in sedentary, middle-aged adults.~        2. The postulated effects of Bikram yoga will be greater when practiced in a heated~          environment.~   "
82419|NCT02488135|"~     Nosebleeds that persist even after adequate traditional nasal packing may require aggressive~     treatment strategies to stop bleeding. Currently these strategies include a surgical approach~     to cut off blood supply to the vessel that is bleeding. FloSeal Hemostatic matrix is a gel~     like medical therapy that is inserted into the nose and is engineered to stop bleeding in~     severe cases, possibly avoiding the need for surgery. In this study the investigators will~     randomize patients to either receive FloSeal Hemostatix matrix or traditional nasal packing~     as a treatment for severe nosebleeds. The main outcome will be whether the investigators are~     able to stop bleeding with FloSeal or traditional packing alone and whether additional~     measures are necessary to stop the bleeding. The investigators will also perform a patient~     comfort survey and cost analysis. Even if FloSeal has equal effectiveness in treating~     nosebleeds as traditional packing, if it is much more comfortable for patients then it may be~     the favourable treatment.~   "
82420|NCT02488122|"~     Osteoporosis has become a worldwide concern an a matter of public health as osteoporosis is a~     major contributing factor associated with insufficiency fracture of the spine, wrist and~     proximal femur, and as a result, can diminish quality of life as well as increase direct and~     indirect healthcare costs.~      The pathophysiology of osteoporosis is based on two main factors; low bone mass and age~     associated architectural changes within the bone, high impact exercise in childhood can~     improve the peak bone mass and bone architecture. The evidence suggests that bone adaptation~     to increased load is optimal in early puberty (Tanner stages I and II) since around 30% of~     total body adult bone mass is accrued during this period.~      However, the optimal exercise program for increasing peak bone mineral content is still~     unclear. Therefore, the aim of this study is to assess if 15 minutes of high-impact exercise~     three times per week improve areal bone mineral density assessed by DXA of pre pubertal girls~     after a ten-month regimen compared to low-impact exercise. This information could highly~     impact the development of public health policies directed to pre pubertal girls.~   "
82421|NCT02488109|"~     The purpose of this study is to compare the efficacy, safety, and cost-effectiveness of lower~     calorie refeeding versus higher calorie refeeding in hospitalized adolescents with anorexia~     nervosa.~   "
82422|NCT02488096|"~     The purpose of this study is to determine if using MRI can improve cancer detection by~     identifying potential cancer targets prior to TRUS-guided biopsy in populations that have~     previous inconclusive results from TRUS-guided biopsies.~   "
82423|NCT02488083|"~     UltraShape Device for Thigh Fat and Circumference Reduction: Prospective, blinded, one arm,~     baseline-controlled clinical study for the evaluation of the UltraShape treatment for~     non-invasive fat and circumference reduction.~   "
82425|NCT02488057|"~     This study will examine the benefits of weight loss alone or in combination with a GLP1~     receptor agonist, liraglutide, on beta cell function in young adult Mexican American (MA)~     women with prediabetes. The Investigators have chosen to focus on MA women because MA women~     are at very high risk for progression to diabetes and have not traditionally been involved in~     weight management studies since they are thought to be difficult to recruit and retain in~     such programs. However, investigators have had particular success in working with young MA~     women using specifically developed ethnic and gender conscious programs. Because weight loss~     does not prevent all progression to diabetes, some participants will receive the diabetes~     medication, liraglutide, which has been shown to stabilize beta cell function. The study will~     also interrogate for polymorphisms of known T2DM genes to correlate with beta cell response~     to weight loss and liraglutide treatment. Additionally, this investigation targets serious~     health disparities in metabolic disease in a highly vulnerable, rapidly growing population,~     testing novel gender and culturally focused intervention strategies and identifying genetic~     biomarkers of response to a pharmacologic intervention that targets the pancreatic ßcell.~      These results will help to a) understand mechanisms of disease, b) personalize treatment~     through identification of a high risk group that may be amenable to specific therapy, and c)~     ultimately, sets the stage for an intervention trial to prevent diabetes, a major chronic and~     costly disease, in Mexican Americans.~   "
82426|NCT02488044|"~     A Phase 1/2 Open-label Study in Patients with Arginase I Deficiency to Investigate the~     Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous AEB1102. This study is designed~     to evaluate the safety and tolerability of IV administration of AEB1102 for the treatment of~     pediatric and adult patients with Arginase I deficiency and hyperargininemia. This study will~     be conducted in 2 parts: Part 1 (Single Ascending Dose Escalation) and Part 2 (Repeated~     Dosing). Each part will be preceded by a baseline assessment of arginine levels. All patients~     who participate in Part 1 may continue AEB1102 dosing in Part 2 if they qualify for continued~     dosing. A data safety monitoring board (DSMB) will provide independent review of study safety~     data and recommend whether the sponsor should continue the study as planned, modify the study~     protocol, or discontinue the study.~   "
82427|NCT02488031|"~     The purpose of this research study is to investigate how the brain and motor behavior changes~     both in individuals with spinocerebellar ataxia and healthy individuals, and to assess~     whether a therapeutic intervention reduces levels of uncoordinated movement and improves~     motor function in spinocerebellar ataxia (SCA).~   "
82428|NCT02488018|"~     The purpose of this study is to determine which of the Ethiopian honeys slowly/rapidly raise~     the blood glucose level.~   "
82429|NCT02488005|"~     Small bowel ultrasound (SBUS) is emerging as a well tolerated, non-invasive, radiation free,~     low cost measure to assess inflammatory bowel disease (IBD), and is being used as first-line~     imaging in Europe. SBUS findings have been shown to correlate with endoscopic findings, and a~     small number of recent studies have looked at change in bowel wall thickness (BWT) in~     response to anti-tumor necrosis factor (anti-TNF) therapy. However, the use of SBUS to detect~     response to anti-TNF therapy has not been tested in pediatric patients. The purpose of this~     study is to apply the use of SBUS to pediatric patients with Crohn's disease and to assess~     response to treatment with infliximab. The investigators will also measure C-reactive protein~     and fecal calprotectin at baseline, and additionally measuring IFX levels and anti-infliximab~     antibodies (ATI) at week 14 to assess change in biochemical response to infliximab treatment,~     as well as correlation between these markers with changes in patient reported outcomes via a~     weighted pediatric Crohn's disease activity questionnaire (wPCDAI) and changes in BWT. This~     study is novel in that it will be the first study in pediatric patients to use SBUS to assess~     response to IFX therapy, and will also be the first study to correlate SBUS findings with~     therapeutic drug monitoring (TDM). This study has the potential to propagate the use of SBUS~     in the pediatric population, as the use of TDM in concert with small bowel imaging~     post-induction will allow the investigators to tailor therapy early in the treatment course.~   "
82430|NCT02487992|"~     The purpose of this study is to evaluate the safety and efficacy of cytokine-induced killer~     cell (CIK) plus S-1 and Bevacizumab vs S-1 and Bevacizumab as Maintenance Treatment for~     patients with advanced colorectal cancer.~   "
82431|NCT02487979|"~     This phase II trial studies how well glembatumumab vedotin works in treating patients with~     osteosarcoma that has come back (recurrent) or does not respond to treatment (refractory).~     Monoclonal antibodies, such as glembatumumab vedotin, may find tumor cells and help kill~     them.~   "
82432|NCT02487966|"~     This is a two-site study that explores the effects of mirror therapy and transcranial Direct~     Current Stimulation (tDCS, Soterix ©) in a randomized factorial controlled trial in which~     patients will be assigned to one of four groups: active tDCS and active MT; sham tDCS and~     active MT; active tDCS and sham MT (which consists of using a covered mirror for the~     therapy); and both sham tDCS and sham MT (covered mirror).~   "
82433|NCT02487953|"~     The purpose of this research study is to determine whether combining electronic nicotine~     delivery systems (ENDS) with nicotine patch treatment will augment abstinence rates compared~     to either treatment alone.~   "
82434|NCT02487940|"~     The study will include 100 women with unexplained recurrent implantation failure undergoing~     IVF/ICSI cycle.~      Patients fulfilling the inclusion criteria will be randomised into two groups.~      Study Group:~      This group will include 50 women with unexplained recurrent implantation failure undergoing a~     trial of IVF/ICSI. This group will receive intravenous infusion of intralipid 20%, on the day~     of oocyte retrieval, a second dose on/ the following day of positive pregnancy test and a~     final dose 2-3 weeks later when attending for pregnancy scan.~      Control Group:~      This group will include 50 women with unexplained recurrent implantation failure undergoing a~     trial of IVF/ICSI. This group will receive intravenous infusion of placebo, on the day of~     oocyte retrieval, a second dose on/ the following day of positive pregnancy test and a final~     dose 2-3 weeks later when attending for pregnancy scan.~   "
82435|NCT02487927|"~     To evaluate the distribution of different types of difficult weaning and the predictive value~     of weaning relative factors.~   "
83107|NCT02479152|"~     The aim of this randomized out-of-hospital cardiopulmonary resuscitation study is to~     investigate haemodynamics generated by the standard mechanical external chest compression~     device (LUCAS™ 2) compared to a new version generating chest compressions and active~     decompression above the initial starting position of the suction cup (LUCAS™ 2AD).~   "
82436|NCT02487914|"~     Drug delivery is conducted through various methods such as injection, phonophoresis, and~     iontophoresis. Iontophoresis is defined as the noninvasive delivery of active ions through~     epidermis using direct current. The direct current has some disadvantages such as skin~     burning and limited time of application. Interferential current is a kind of alternating~     currents without limitations of direct current; so the purpose of this study was to~     investigate and compare the effects of Lidocaine, interferential current and Lidocaine~     iontophoresis using interferential current.~   "
82437|NCT02487901|"~     Ultrasonic bone osteotome has been utilized in various surgical field, but the use in~     neurosurgery especially in spine surgery is not widely spread. In the present study, the~     investigators are going to compare bony fusion rate after cervical laminotomy either with~     ultrasonic osteotome or conventional drill.~   "
82438|NCT02487888|"~     The purpose of this study is to evaluate the impact of genetic testing on healthcare~     decisions and patient outcomes for patients suffering from pain, cardiovascular problems,~     Arthritis, Type II Diabetes, and/or Mental Health disorders. Results of genetic testing will~     also be compared with the clinical outcome measures collected to discover novel genetic~     factors that may influence patient care.~   "
82439|NCT02487875|"~     Background: Individuals with COPD may present reduced peripheral muscle strength, which leads~     to impaired mobility. Comprehensive pulmonary rehabilitation (PR) should include strength~     training, in particular to lower limbs. Furthermore, simple tools for the assessment of lower~     extremity muscles' performance are required. Objectives: To assess the muscle strength of~     COPD patients by the sit-to-stand test (STST) as compared to the one-repetition maximum~     (1-RM), considered as the gold standard in non-laboratory situations, and to evaluate the~     responsiveness of STST to a PR program with specific strength training (SPR), compared to~     usual PR program (UPR). Methods: 60 moderate-to-severe COPD inpatients were randomly included~     into either the SPR or into the UPR. 30-sec STST, 1-min STST, 1-RM and 6MWT were assessed~     before and after PRs.~   "
82440|NCT02487862|"~     Psychological conditions, particularly psychosocial stress, have been implicated as risk~     indicators for periodontal disease. Minimal evidence in literature exists to assess the~     effect of stress reduction therapy (SRT) in the outcome of non-surgical periodontal therapy~     (NSPT). Hence, the present study was aimed at exploring the possibility of employing SRT in~     stressed subjects (assessed using questionnaire data and serum cortisol level) as an~     adjunctive intervention in the management of periodontal diseases.~   "
82441|NCT02487849|"~     The combination of optimal cytoreductive operation (according to Desktop II criteria), HIPEC~     with Carboplatin 800 mg/m² KOF (Körperoberfläche) and following platinum-based systemic~     chemotherapy should be executed In patients with platinum-sensitive recurrence of ovarian~     carcinoma. Condition for HIPEC is attainment of optimal cytoreduction (R0) and experts~     judgement of a complication-free prolongation of narcosis after finishing the surgery. HIPEC~     will be administered additionally to standard therapy. If HIPEC was executed the number of~     systemic given platinum-based chemotherapy decreases for one cycle.~      This regime should be investigated in terms of safety of performance, quality of life for the~     patients and consequences for the following systemic chemotherapy.~   "
82442|NCT02487836|"~     For many years, the treatment of jaundice due to head pancreatic adenocarcinoma is based on~     the endoscopic biliary stent. This technique has been shown to be preferable to a surgical~     shunt.~      Recently, adjuvant chemotherapy with FOLFIRINOX regimen (clinical trial) has revolutionized~     the treatment of metastatic pancreatic adenocarcinoma increasing overall survival in a major~     way. This design will also be developed in patients with neoadjuvant tumor called~     borderline (the limit of the resectability).~      However, several conditions (protocol) are required to consider the implementation of this~     design : age ≤ 75 years, PS 0 or 1, good hematological parameters and bilirubin ≤ 1.5 times~     the ULN.~      In addition, a randomized study showed that preoperative biliary stent treatment, despite a~     success rate of 94%, is associated with more complications than surgery fast (related gesture~     bladder).~      It would be interesting to analyze, prospectively, the fate of a series of patients with~     cancer of the pancreatic head with compression of the lower part of the bile duct, PS 0 or 1~     and for which the only limit to FOLFIRINOX design is jaundice or high risk of jaundice.~   "
82443|NCT02487823|"~     To determine the maximum-tolerated dose (MTD) of BKM120 when administered orally in~     combination with daily bicalutamide and LH-RH agonists to men with non castrate metastatic~     prostate cancer.~   "
82444|NCT02487810|"~     The purpose of this study is to determine whether there are systematic differences between~     the decisions patients make intuitively versus deliberatively about life-sustaining medical~     therapies.~      The targeted population is inpatients at the Hospital of the University of Pennsylvania with~     serious medical problems. The study will involve facilitated interviews with patients using a~     survey instrument developed in Qualtrics.~   "
82445|NCT02487797|"~     Oxytocin is a medication that is often used to strengthen contractions to overcome delayed~     labor progress. The primary aim of this study is to determine whether receiving a higher dose~     of oxytocin lowers the chance of needing a cesarean section when compared to a lower dose of~     oxytocin. Other aims include examining the relationship between dose of oxytocin regimen and~     length of labor, postpartum hemorrhage, intrauterine infection, umbilical cord gas, neonatal~     Apgar score <5 at 5 minutes, and need for neonatal intensive care.~   "
82446|NCT02487784|"~     The primary aims of this study are to compare the clinical and histologic results of bone~     regeneration with a cancellous block allograft versus MinerOss Cortico cancellous particulate~     allograft mixed with autogenous bone chips after 4 months of healing. Titanium reinforced~     hd-PTFE (Cytoplast) membrane GBR will be used to cover the bone grafts.~      Specific Aim 1: To compare the baseline to 4 month change in clinical ridge width and height.~      Specific Aim 2: To compare the histologic percent of vital and nonvital bone and trabecular~     space at 4 months.~      The primary outcome variable is the change in horizontal ridge width. The secondary outcomes~     are the change in ridge height and the percent histologic composition of the augmented site.~   "
82447|NCT02487771|"~     This is a continuation study to KUDOS (NCT00266825). The purpose of this study is to~     follow-up with participants on the original study to determine if the effects of increasing~     DHA intake during pregnancy increase cognitive development in 2 to 6 year-old children.~   "
82448|NCT02487758|"~     Ridge Preservation Comparing the Clinical and Histologic Healing of Flap vs. Flapless~     Approach to Grafting~   "
82451|NCT02487719|"~     Examination of iron supplements routinely used in pregnancy to compare these with one another~     regarding effectiveness in the prevention of iron deficiency.~      Determination of ferritin / hemoglobin every pregnant woman under the first routine check.~     Classification into one of three subgroups (group 1: iron sulfate, Group 2: iron polymaltose,~     Group 3: multivitamin- multimineral) depending on the measured values. Repetition of~     hemoglobin every 8 weeks, at the entrance to birth and postpartum day 1, additional provision~     of ferritin at the entrance to birth. In addition, registration of each child's birth weight~     and gestational age.~   "
82452|NCT02487706|"~     Data on the capacity of hemodialysis to remove dolutegravir (DTG) from plasma in patients~     with end-stage renal disease (ESRD) on hemodialysis (HD) are lacking. If DTG was removed from~     plasma by HD, it would be possible to have subtherapeutic drug concentrations at the end of~     HD sessions.~   "
82453|NCT02487693|"~     The purpose of this study is to determine whether combining of radiofrequency ablation (RFA)~     and cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with~     ovarian carcinoma.~   "
82454|NCT02487680|"~     It has previously been shown in healthy overweight subjects, that table water including a~     defined amount of amino acids and chromium can decrease the postprandial glucose. In this~     study, the effect of this table water on glucose excursions after a test meal containing a~     defined amount of available carbohydrates, protein and fat will be studied in healthy~     subjects. The study will be conducted in a cross -over design, double blinded and placebo~     controlled including 20 participants. The primary endpoint of the study is the incremental~     area under the curve for plasma glucose (iAUCgluc) within 180 minutes after ingestion of the~     meal.~   "
82455|NCT02487667|"~     In adulthood, limited mobility and pain are very common and often the first clear sign of~     functional decline. The loss of independent mobility is related to higher rates of functional~     disability and mortality; however, it is also susceptible to interventions through exercises.~     With aging, changes in peripheral and central nervous system also occur, which lead to~     degradation of the sensory receptors as well as a loss of muscle mass and coordination.~     However, both, structural and functional dysfunctions of the nervous system, can be mitigated~     by increasing physical activity.~      The aim of this study is therefore, to study the effects on pain and functional capacity of a~     therapeutic exercise training program in an adult people sample. The therapeutic exercise~     machines proposed in this trial have not been previously analyzed and provide insight into~     this field due to their design. The design of this new machines allows the adaptation to each~     concrete clinical situation by the adjustment of different parameters such as feedback, range~     of movement, time of repetition, intensity, speed and rhythm, which facilitate motor control~     training.~   "
82456|NCT02487654|"~     Atrial fibrillation (AF) is a common heart rhythm disorder which can significantly affect a~     patient's quality of life.~      Abnormal electrical activity from the 4 veins that drain into the left atrium (top left~     chamber of the heart), is the main cause of this condition. Catheter ablation and this~     involves making tiny burns within the left atrium that electrically disconnects these veins~     form the rest of the left atrium (pulmonary vein isolation). Abnormal electrical activity can~     be as a result of the nerves supplying the heart and destroying the collection of these nerve~     endings (ganglionic plexi ablation) can be helpful in eliminating the abnormal electrical~     activity. Catheter ablation for AF and study the affect of ganglionic plexi ablation on the~     success of this treatment option. All patients will be grouped by low or high preexisting~     scar. The investigators plan to recruit patients undergoing ablation with proportionate~     numbers in both existing scar groups. Patients will be randomly assigned into the two~     treatment groups each with different treatment strategies~        1. Pulmonary vein isolation alone~        2. Ganglionic plexi ablation alone There will be pre and post procedure tests as per~          optimal clinical practice. Some patients may require a repeat procedure if they have~          documented recurrence. This will be done after a minimum of 6 months. The redo-procedure~          will be pulmonary vein isolation for both groups with the ganglionic plexi arm receiving~          a lesions encircling the pulmonary veins. This will enable the study to report outcomes~          from 3 groups.~   "
82457|NCT02487641|"~     This study aim to evaluate the quality of fetal ultrasound in obese pregnant women. The~     hypotheses is that an early ultrasound will improve the quality of the ultrasound in obese.~   "
82458|NCT02487628|"~     The purpose of the study is to evaluate the safety and effectiveness of HQ® Matrix Soft~     Tissue Mesh for the Treatment of Inguinal Hernia. Half of participants will receive HQ®~     Matrix Soft Tissue Mesh, while the other half will receive ULTRAPRO® Partially Absorbable~     Lightweight Mesh.~   "
82459|NCT02487615|"~     Subclinical atherosclerosis is the atherosclerotic process identified before clinical~     symptoms and thus it can be a useful marker of future cardiovascular events. It can be~     evaluated by many methods. This study included the diagnosis of subclincal atherosclerosis by~     four different methods: coronary calcium score, carotid doppler ultrasound to quantify intima~     media thickness and carotid plaques, exercise stress test and ankle brachial index. Clinical~     data, anthropometric measures (body mass index, abdominal circumference), markers of~     inflammation (high sensitive - C reactive protein, TNF alfa and Lipoprotein Associated~     Phospholipase A2), fat tissue function (leptin, resistin and adiponectin), glucose metabolism~     (fasting plasma glucose, glycated hemoglobin and insulin) and genetics markers of~     atherosclerotic process were evaluated as biomarkers of subclinical atherosclerosis in a~     uneventful population.~   "
82460|NCT02487602|"~     The purpose of the study is to evaluate the gastrointestinal behaviour of a novel weight loss~     device in vivo to further understand the device's mechanism of action in aiding weight loss.~   "
82473|NCT02487433|"~     This study will evaluate the drug behavior and safety of a single dose of the 22 milligram~     tofacitinib (CP-690,550) modified-release formulation in 18 healthy volunteers when taken~     after eating a high fat meal (the effect of food). This will be compared to the drug behavior~     and safety of a single dose of the 22 milligram tofacitinib (CP-690,550) modified-release~     formulation when taken after a 10 hour fast.~   "
82614|NCT02485587|"~     The purpose of this study is to determine whether individualized biofeedback of arousal (skin~     conductance) is effective in the treatment of aggressive behavior problems in children and~     adolescents with either predominantly impulsive (reactive) and/or high callous unemotional~     traits (proactive) subtypes of aggression when compared to treatment as usual (TAU), and~     induces normalization when compared to a group of typically developing children receiving no~     intervention.~   "
82461|NCT02487589|"~     Fall incidents are the third cause of chronic disablement in elderly according to the World~     Health Organization (WHO). Recent meta-analyses shows that a multifactorial falls risk~     assessment and management programs are effective in all older population studied. However,~     the application of these programs may not be the same in all National health care setting~     and, consequently, needs to be evacuated by cost-effectiveness studies before to plan this~     intervention in regular care. In Italy structured collaboration between hospital staff and~     primary care is generally lacking and the role of Information and Communication Technologies~     (ICT) in a fall prevention program at home has never been explored.~      This is a two-group randomized controlled trial aiming to evaluate the effect of a home-based~     intervention program, delivered by a multidisciplinary health team, in preventing falls in~     elderly. The home tele-management program, previously adopted in our Institute for chronic~     patients, will be proposed to elderly people affected by chronic diseases at high risk of~     falling at time of hospital discharge. The program will involve the hospital staff and will~     be managed thanks to the collaboration between hospital and primary care setting. Patients~     will be followed at home for 6 months after hospital discharge. A nurse-tutor will be the~     case manager and telephone support, telemonitoring and tele-exercise will characterize the~     intervention program. People in the control group will receive the usual care. The main~     outcome measure of the study will be the percentage of patients sustaining a fall during the~     6-months follow-up period. An economic evaluation will be performed from a societal~     perspective and will involve calculating cost-effectiveness and cost utility ratios.~   "
82462|NCT02487576|"~     This human dietary intervention study with a cross-over design aims to investigate the effect~     of two different diurnal patterns of meal composition on peripheral circadian clocks and~     energy metabolism in healthy men.~   "
82463|NCT02487563|"~     Isolated thrombocytopenia is a common and severe complication of HSCT, which often leads to~     an increased risk of life-threatening hemorrhage, frequent requirement of platelet~     transfusions and extended hospital stays, representing a challenging clinical problem.~     Current treatments for thrombocytopenia after HSCT are frequently unsatisfactory in platelet~     recovery and for preventing potentially fatal bleeding complications. Therefore, it is urgent~     to explore an effective therapy to improve the outcomes of thrombocytopenia after HSCT.~     Previous studies have demonstrated that decitabine, a hypomethylating agent, may reduce~     platelet transfusions in myelodysplastic syndrome (MDS) patients. The investigators conducted~     an prospective clinical trial to evaluate the safety and efficiency of rhTPO and decitabine~     in the treatment of thrombocytopenia following HSCT.~   "
82464|NCT02487550|"~     The purpose of this study is to show if vaccination with autologous dendritic cells pulsed~     with tumor lysate in combination with Cytokine-Induced Killer Cell (CIK) can induce a~     measurable immune response in patients with renal cell carcinoma, and to evaluate the~     clinical effect of the regimen.~   "
82465|NCT02487537|"~     Epidemiological data suggest, that not only sugar-based, but also artificially sweetened soft~     drinks may play a role in the development of diabetes.~      Recent studies in animals and humans have shown, that artificial sweeteners (AS) influence~     metabolic responses after glucose ingestion, possibly alter the intestinal microbiome and~     even modulate incretin release.~      Data on human subjects are sparse and controversial, especially in a long-term manner. We~     therefore conduct a cross-over study to assess metabolic response to sweetened vs.~     non-sweetened soft drinks, which are consumed over a period of 4 weeks.~   "
82466|NCT02487524|"~     Investigators aim to identify the key phenotypes (biological, psychological, genetic)~     involved in the transition from acute to chronic neuropathic pain (NP) by comparison of the~     neuropathic pain phenotypes and genomics of patients developing NP or not under similar nerve~     injury conditions. The cohort is part of a previous prospective study of 1000 patients~     operated for breast cancer of whom 350 have surgeon defined intercostobrachial nerve~     resection during operation with or without persistent pain and additional 50 patients with~     pain, but no nerve resection during operation. Patients fill in questionnaires and a detailed~     sensory examination, cognitive tests, and a cold water test with autonomic nervous system~     monitoring are performed during the research visit. A selected group of patients undergo~     quantitative sensory testing (QST).~   "
82467|NCT02487511|"~     It is recommended as the first line treatment regimen to eradicate Helicobacter pylori (HP),~     7 or 14 days treatment of proton pump inhibitor (PPI) based triple therapy consisting of one~     PPI and two antibiotics, clarithromycin and amoxicillin. In the case of treatment failure, 7~     or 14 days of quadruple therapy (PPI＋metronidazole＋tetracycline＋bismuth) is recommended.~      This study aims to investigate which duration would be better for eradication of HP. The~     study design is a randomized controlled trial. The patients were randomly assigned to 7 days~     or 14 days treatment groups. Primary endpoint was the eradication rate of PPI based triple~     therapy. Secondary endpoints were to compare the rate of drug compliance and side effects in~     both groups.~   "
82468|NCT02487498|"~     The purpose of this study is to demonstrate that the efficacy of the combination product~     QVA149 is similar to the efficacy of the combination product umeclidinium/vilanterol on a~     pre-specified endpoint of FEV1 AUC0-24h while maintaining an acceptable safety profile.~   "
82469|NCT02487485|"~     The aim of the study is to provide insight into the impact of the immunosuppressant drug~     sirolimus, on the antidepressant effects of the prototypal rapid-acting antidepressant~     medication, ketamine.~   "
82470|NCT02487472|"~     The purpose of this study is to assess the burden of Herpes zoster (HZ) and post-herpetic~     neuralgia (PHN) among people ≥ 50 years old in France, in terms of healthcare resources used,~     medical direct and indirect costs, as well as pain severity and impact on quality of life.~   "
82471|NCT02487459|"~     This is an open-label, non-randomized study to evaluate the safety of two planned infusions~     of BPX-501 T cells after partially mismatched, related (haploidentical) HSCT in adults with~     hematologic malignancies.~   "
82472|NCT02487446|"~     The purpose of this study is to demonstrate that the efficacy of the combination product~     QVA149 is similar to the efficacy of the combination product umeclidinium/vilanterol on a~     pre-specified endpoint of FEV1 AUC0-24h while maintaining an acceptable safety profile.~   "
82497|NCT02487121|"~     This project examines the effects of differing schedules of extended care contact following~     weight loss treatment in order to prevent weight regain following treatment.~   "
82474|NCT02487420|"~     1. The investigators here want to test the hypothesis that a total period of 18 months of~          gradual open introduction of a certain egg product with regard to full egg tolerance~          induction is not inferior when compared to a total period of 30 months gradual open~          introduction of a certain egg product (see steps for the specific egg products) after~          tolerance for baked egg has been obtained.~        2. The investigators also want to define step-specific 'tolerance-failures' and study the~          relevance of specific IgE to specific egg components to predict failures at each step.~   "
82475|NCT02487407|"~     In the double-blind, cross-over part of the study, ODM-109 capsules and placebo capsules for~     ODM-109 will be administered for 2 weeks separated by a 19-23 days wash-out period. During~     each treatment period of the double-blind cross-over part, there will be a baseline visit~     (day 1) and 2 visits (5 ± 2 and 14 ± 2 days) after the start of study treatment. After~     completing the 3rd treatment period, the subjects will continue in the open-label follow-up~     part for 6 months. During the open-label follow-up, visits will be at 1, 3 and 6 months. An~     end-of-study visit will take place 14-25 days after the last study treatment administration~     for each subject. The study duration will be about 13-14 weeks for the double-blind~     cross-over part, and about 9-10 months for the entire study including the 6 months open-label~     follow-up.~      The number of randomised study subjects is planned to be approximately 54 in cross-over~     comparison. The maximum number of subjects will not exceed 70.~      Primary objective is to investigate the efficacy of oral ODM-109 on respiratory function in~     patients with amyotrophic lateral sclerosis (ALS).~   "
82476|NCT02487394|"~     The purpose of the study is to better understand the function of asthma and COPD, and~     response to therapy. There are two Phases to this study broken into two arms. In Phase I, our~     propose is to use discovery proteins and techniques to identify protein expression~     signatures. In Phase II, is to establish and validate the predictive value of protein~     signatures for treatment responses using inhaled corticosteroids.~   "
82477|NCT02487381|"~     The study evaluates the gene-environment interaction of the COMT-genotype on the effects of~     the phytocannabinoids delta-9-tetrahydrocannabinol, cannabidiol or a combination of both on~     induction of psychotic symptoms, endocannabinoid levels in human body fluids, neuronal~     processing, and neural oscillations. In addition the effects of the phytocannabinoids on~     lipid levels in serum and cerebrospinal fluid, cognition, neural synchrony and neuronal~     processing assessed by EEG and fMRI.~   "
82478|NCT02487368|"~     The needle stimulation pad is a self-care device, which has been promoted for pain control~     and well-being. The aim of the study was to test the efficacy of the pad for~     chronic/recurrent low back pain treatment.~      Patients with non-specific chronic or recurrent low back pain were selected from a large~     health insurance company database and advised to use the pad daily for two weeks; outcomes~     were assessed at baseline, weeks 2 and 14. Primary outcome measure was pain intensity at week~     2; secondary outcome measures included the Oswestry disability index (ODI), health-related~     quality of life (SF-36), the fear avoidance beliefs questionnaire (FABQ), analgesic~     medication consumption and safety.~   "
82479|NCT02487355|"~     The study will conduct to compare the efficacy of Magnesium sulphate & dexmedetomidine used~     as adjuvants to bupivacaine in caudal block to provide intra-operative anesthesia as well as~     post -operative analgesia in pediatric patients.~   "
82480|NCT02487342|"~     Comprising two experiments, the investigators assessed the metabolic, endocrine and~     appetite-related responses to acute (1-d, part 1) and daily mid-morning milk consumption~     (28-d, part 2) in adolescent males (15-18 y).~   "
82481|NCT02487329|"~     The purpose of this randomized clinical study was to evaluate the efficiency of Er,Cr:YSGG~     laser irradiation combined with a resin based tricalcium silicate material and calcium~     hydroxide (CH) in direct pulp capping for 3 months follow-up period.Sixty permanent vital~     teeth without symptoms and radiographic changes were randomly assigned to 4 groups (n=15): Gr~     1: The exposed area was sealed with CH paste, Gr 2: The treated area was sealed with CH paste~     following Er,Cr:YSGG laser irradiation at an energy level of 0,5 W without water and 45% air,~     Gr 3: Resin based tricalcium silicate material (TheraCal LC) was applied directly to the~     exposed pulp, Gr 4: TheraCal LC was applied following irradiation with Er,Cr:YSGG laser.~   "
82482|NCT02487316|"~     The purpose of this study is to determine the efficacy and safety of crizotinib combined with~     CHOP chemotherapy for patients with ALK(+) Systemic Anaplastic Large Cell Lymphoma.~   "
82483|NCT02487303|"~     This study will compare IV (intravenous) versus oral (PO) acetaminophen for postoperative~     pain after scheduled, elective Cesarean delivery. All patients will receive a standardized~     spinal anesthetic for operative anesthesia and will be randomized into one of three groups:~     (group 1) 1 gram IV acetaminophen every 8 hours for three doses, (group 2) 1 gram oral~     acetaminophen every 8 hours for three doses, or (group 3) no acetaminophen. This will be a~     randomized, open label study.~   "
82484|NCT02487290|"~     The study is a non-randomized, multi-center safety and feasibility trial of Aneufix ACP-T5 to~     treat patients with Isolated type II endoleak in the presence of a non-shrinking AAA sac~     following an EVAR procedure.~   "
82485|NCT02487277|"~     We will be conducting a Phase II study investigating PEGPH20 in combination with gemcitabine~     and nab-paclitaxel in patients with borderline resectable PDAC at the Helen Diller Family~     Comprehensive Cancer Center at UCSF. There are multiple definitions of borderline resectable~     PDAC including the MD Anderson definition and the criteria developed during the Consensus~     Conference sponsored by the American Hepato-Pancreato-Biliary Association, Society of~     Surgical Oncology, and Society for Surgery of the Alimentary Tract. Borderline resectable~     PDAC cases will be identified per the definition developed in the currently running~     inter-group pilot trial for borderline resectable pancreatic cancer (NCT01821612). Per this~     trial, borderline resectable PDAC is defined as presence of any one or more of the following~     on CT:~        -  An interface between the primary tumor and the superior mesenteric vein or portal vein~          (SMV-PV) measuring ≥ 180° of the circumference of the vessel wall~        -  Short-segment occlusion of the SMV-PV with normal vein above and below the level of~          obstruction that is amenable to resection and venous reconstruction~        -  Short segment interface (of any degree) between tumor and hepatic artery with normal~          artery proximal and distal to the interface that is amenable to resection and~          reconstruction.~        -  An interface between the tumor, and SMA measuring < 180º of the circumference of the~          vessel wall.~      This trial will be conducted in two parts. In Part I, pre-treatment EUS-guided core biopsies~     of the pancreatic tumor, CA 19-9 levels and functional MRIs including DCE-MRI and DWI-MRI~     will be obtained for the first fifteen patients enrolled. After a 1-week run-in period with~     PEGPH20 on days 1 and 4, patients will have repeat EUS-guided core biopsies, functional MRI,~     CA 19-9 level and baseline CT chest, abdomen and pelvis. Subsequently, patients will be~     started on treatment with PEGPH20, gemcitabine and nab-paclitaxel given weekly for 3 weeks,~     every 28 days. To evaluate the disease response to treatment, CA 19-9 levels will be checked~     monthly and restaging CT chest, abdomen and pelvis will be obtained every 8 weeks. If there~     is disease progression at any point in the study, patients will be taken off of study and~     alternative treatments will be offered. At the completion of 4 cycles of therapy, restaging~     CT scans will be obtained to determine resectability. If the patients are found to have~     resectable disease, an additional functional MRI will be obtained to evaluate the PDAC~     stroma. If the patients are able to have successful surgeries, tissue analyses will be~     performed on the resected pancreatic tumor. These patients will then proceed to get 2 cycles~     of adjuvant chemotherapy with gemcitabine and nab-paclitaxel. If the patients are deemed to~     be surgical candidates but are found to have unresectable disease in the operating room, an~     intraoperative core biopsy of the pancreatic tumor will be obtained for tissue analyses. At~     the time of initiation of therapy with PEGPH20, patients will be started on prophylactic dose~     of enoxaparin 1 mg/kg subcutaneous daily. This will be continued throughout the study~     participation.~      In Part II, an additional 21 patients will be enrolled, and will begin neoadjuvant therapy~     with PEGPH20, gemcitabine and nab-paclitaxel without the 1 week run-in of PEGPH20-only or the~     pre- and post-run-in EUS-guided biopsies.~   "
82486|NCT02487264|"~     A retrospective analysis of all patient presenting with multiple rib fractures to the~     emergency room of Penn State Hershey Medical Center between 2010-2012. Patient demographics,~     cause of fracture, outcomes, chronic medical conditions, vital signs, length of stay, pain~     levels and treatment, and sequelae will be recorded and analyzed.~   "
82498|NCT02487108|"~     The primary objective of this study is to evaluate the analgesic efficacy of hydrocodone~     bitartrate/acetaminophen immediate-release tablets at doses of 5.0 mg/325 mg, 7.5 mg/325 mg,~     and 10 mg/325 mg every 4 to 6 hours compared with placebo in treating patients with moderate~     to severe pain following bunionectomy~   "
82525|NCT02486757|"~     Irregular menstrual cycles are common in girls for several years after their first menstrual~     period. The cause of abnormal menstrual cycles during this time is not well-understood. The~     purpose of this study is to: 1) monitor girls during a menstrual cycle (with blood and urine~     sampling and serial pelvic ultrasounds) to identify those girls who do not ovulate (release~     of an egg from the ovary), and 2) determine whether cycles can be corrected by treating girls~     with a short course of low-dose estrogen and progesterone.~   "
83108|NCT02479139|"~     The purpose of this study is to establish the therapeutic range of ANT-1207 in the treatment~     of primary axillary hyperhidrosis.~   "
82487|NCT02487251|"~     Socioeconomic disparities in early childhood place low-income children at 1.5 to 2 times~     higher risk for obesity compared to middle- to upper-income children. Obesity interventions~     have turned toward the promotion of family mealtimes. Many families report barriers to~     regular mealtimes but barriers in low-income families are intensified. While most prevention~     efforts focus solely on nutrition education and knowledge, this project's approach is built~     on the premises that: 1) enhancing parents' abilities to implement healthy family mealtimes~     is critical to effective obesity prevention; and 2) inconsistent implementation of family~     meals is not due only to a lack of nutrition education or knowledge, but to the adverse~     effects of poverty on parents' capabilities to plan and execute mealtime. The investigators~     propose to test the main, additive and interactive effects of 6 intervention components~     reflecting differing levels of supports to increase the frequency of healthy family mealtimes~     and ultimately reduce childhood obesity prevalence. The investigators will test 6~     intervention components in a Screening Phase (N = 520), resulting in the implementation and~     evaluation of a final intervention model in the Confirming (N = 250) reflecting the most~     effective intervention components tested in the Screening Phase. The investigators~     hypothesize that providing low-income families with effective supports to enhance family~     capability to plan and implement family mealtimes will lead to increased frequency of~     mealtimes and to improvements in children's dietary quality and adiposity indices. Results~     will inform policy (e.g. where limited resources may be allocated for maximum benefit) and~     Extension efforts (e.g. supports most effective in promoting family meals).~   "
82488|NCT02487238|"~     The PediFETCh study is a pilot trial designed to assess the feasibility of fecal microbial~     transplants for the therapy of pediatric ulcerative colitis (UC) and pediatric inflammatory~     bowel disease-unclassified (IBD-U). Investigators will test the hypothesis that a protocol of~     twice-weekly retention enemas delivered over six weeks, using fecal transplant material from~     a healthy donor, will improve clinical and biological disease markers in patients with~     pediatric UC or IBD-U.~   "
82489|NCT02487225|"~     This is a single center randomized, double-blind, placebo-controlled study, to be conducted~     at Mayo Clinic, Rochester, Minnesota.~      The objective of our research is to determine whether inhibition of the tumor necrosis~     factor- alpha (TNF-a) pathway by Pentoxifylline reduces inflammatory markers in AP and~     whether it is safe, beneficial and well-tolerated in patients with acute pancreatitis AP. The~     study will have 2 groups of 75 patients each, all with AP, randomly assigned to either the~     drug or a placebo, which looks like the drug, for a period of 3 days or until the time they~     are discharged, if hospital discharge is within 7 days of admission. The levels of markers of~     inflammation of C-reactive protein (C-RP), Interleukin-6 (IL-6), Interleukin-8 (IL-8) and~     Tumor Necrosis Factor-alpha (TNF-a) will be measured at baseline and on 5 successive days or~     until the time of discharge, whichever occurs earlier.~      Subjects will be adult patients =18 years or older admitted to the hospital within 72 hours~     of diagnosis of acute pancreatitis (AP) as defined by at least two of the following: (1)~     amylase and/or lipase greater than 3x upper limit of normal, (2) characteristic~     cross-sectional imaging, (3) typical abdominal pain. Enrollment into the study should take~     place 24 hours of admission.~      Determination of group size was based on the previous pilot study to decrease any of the~     important adverse outcomes, providing for a dropout rate of 10% during the study. During~     2012, 263 patients with AP were admitted to this institution, which possesses the needed~     infrastructure for successful completion of clinical drug intervention trials.~   "
82490|NCT02487212|"~     The objective of this study is to evaluate the efficacy and safety of using ablative~     fractional laser- assisted topical corticosteroid delivery for the treatment of hypertrophic~     scar.~   "
82491|NCT02487199|"~     This study evaluates the efficacy and safety of ombitasvir/paritaprevir/ritonavir with or~     without dasabuvir in adults with hepatitis C virus (HCV) genotype 1a (GT1a) or genotype 4~     (GT4) infection and with severe kidney impairment or end-stage kidney disease.~   "
82492|NCT02487186|"~     The aim of this clinical study is to asses the effect of ultrasonic periodontal debridement~     associated to locally delivered doxycycline (20%) by PLGA microspheres on chronic generalized~     periodontitis treatment.~   "
82493|NCT02487173|"~     The primary purpose of this study is to validate the sensitivity and specificity of the~     Respirio Flu Test in detecting Influenza A, when used by subjects, as compared to the gold~     standard for detection, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).~      The secondary aims are to:~        -  validate the sensitivity and specificity of the Respirio Flu Test in detecting Influenza~          B , when used by subjects, as compared to the gold standard for detection, Reverse~          Transcriptase Polymerase Chain Reaction (RT-PCR).~        -  assess agreement (positive and negative) between Respirio Flu Test and Sofia® Influenza~          A+B Test in detecting Influenza A;~        -  assess agreement (positive and negative) between Respirio Flu Test and Sofia® Influenza~          A+B Test in detecting Influenza B;~        -  evaluate the correct interpretation of the Respirio Flu Test results by subjects with~          Influenza-like illness symptoms;~        -  evaluate the subjects' satisfaction with the convenience, comfort and ease of use of the~          Respirio Flu Test;~        -  evaluate the subjects' comprehension of the Respirio Flu Test labelling; and~        -  establish the minimum sample weight required to achieve a result with the Respirio Flu~          Test.~   "
82494|NCT02487160|"~     The purpose of this study is to evaluate the safety and performance of the SBL-3 intraocular~     lens.~   "
82495|NCT02487147|"~     This study will compare the efficacy of the Free Air Portable Air Powered Respirator (PAPR)~     system versus a N95 mask in preventing nasal detection of influenza following an exposure.~     The investigators hypothesize the use of the Free Air PAPR system will be superior to a N95~     respirator at interrupting the exposure of the study participants to aerosolized influenza~     virus particles.~   "
82496|NCT02487134|"~     Patients with at least two risk factors for incisional hernia undergoing abdominal surgery~     are eligible for inclusion. After accepting informed consent, patients are randomized into~     either closing the abdominal wall in a regular way with fascial sutures, or closing with~     fascial sutures together with placing a TIGR mesh as described. All patients are then~     monitored for signs of infection, wound rupture, incisional hernias, subcutaneous seroma as~     well as postoperative symptoms. All patients will be followed for at least 5 years. One year~     postoperatively, a computer scan is performed to detect asymptomatic incisional hernias.~   "
82499|NCT02487095|"~     Background:~      Chemotherapy damages cancer cell DNA so the cells die and the tumor shrinks. But it may stop~     working in some people over time. This is partly due to efficient DNA damage repair~     mechanisms used by tumor cells. VX-970 may stop cancer cells from preventing the repair of~     DNA damaged by chemotherapy. The purpose of this study is to see if using the chemotherapy~     drug topotecan along with the drug VX-970 will improve the response to chemotherapy.~      Objective:~      To study the safety and efficacy of VX-970 and topotecan in treating small cell lung cancer.~      Eligibility:~      Adults at least 18 years old with small cell lung cancer .~      Design:~      Participants will be screened with medical history, physical exam, blood and heart tests, and~     scans. Most of these tests are part of their routine care. Most of these tests will be~     repeated throughout the study.~      The study is set in 21-day cycles. Participants will get topotecan IV on days 1 through 5.~     They will get VX-970 IV on day 5 alone or on day 5 and day 2.~      Participants doctors will monitor them weekly for the first cycle, every 3 weeks after that.~      For Part 1 of this Study the doses of topotecan and VX-970 will be increased (according to~     the Protocol) to determine the maximum safe dose of the combination. The maximum safe dose of~     the combination is the dose at which no more than 1 in 6 people have an intolerable side~     effect.~      More participants will join in Phase 2. They will take the drugs at the maximum safe dose, on~     the same schedule as the drugs were taken in Phase 1.~      Participants will give samples of blood, hair, and tumor tissue (optional) at different~     times. They will discuss side effects at every visit.~      A month after stopping taking the drugs, participants will have a physical exam and blood~     drawn. They will have follow-up phone calls every 3 months.~   "
82500|NCT02487082|"~     The purpose of this study is to test the combined effect of melatonin and donepezil on~     improving sleep and behavior in children with Autism Spectrum Disorders. Melatonin is a~     natural neurohormone that helps regulate sleep and wake cycles. Donepezil is used to improve~     mental function for people with Alzheimer's disease. Children with Autism Spectrum Disorders~     are more likely to have problems sleeping than other children. This difficulty has been~     linked to daytime behavioral problems and family stress.~   "
82501|NCT02487069|"~     The purpose of this study is to compare the efficacy of allogeneic hematopoietic stem cell~     transplantation (allo-HSCT) from matched sibling donor (MSD),matched unrelated donor (MUD)~     and haploidentical related donors(HRD) in the treatment of hematologic malignancy.~   "
82502|NCT02487056|"~     The purpose of this study is to compose a national database of the etiologies, clinical and~     demographic characteristics, using diagnostic tests, precipitating and risk factors,~     management of from intensive care unit or coronary care unit to hospital discharge, length of~     stay in the intensive care unit and hospital, in-hospital mortality and discharge medications~     of hospitalized acute heart failure patients in Turkish population.~   "
82503|NCT02487043|"~     Despite improvements in oral health among children, children living in areas characterized by~     low socio-economic status still have a significant disease burden with regard to dental~     caries. Special efforts to prevent disease development in this group of children have been~     unsuccessful. Small children with extensive treatment needs often have limited abilities to~     cooperate and to provide quality dental care in this patient group, general aneaethesia (GA)~     may often be the treatment modality of choice. Preschool children treated under general~     anesthesia have significantly higher caries prevalence (deft and defs), apical parodontitis~     and infection due to pulpal necrosis. They also have significantly more emergency visits and~     previous use of treatment under sedation.~      This study aim to test the hypothesis, that a telephone based case management intervention~     for children with severe early childhood caries can prevent further caries development in~     preschool children who are treated under general anesthesia for severe early childhood~     caries.~   "
82504|NCT02487030|"~     The primary objective of this study was to evaluate the efficacy, safety, and tolerability of~     ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) with or without ribavirin (RBV)~     in Egyptian adults with chronic genotype 4 hepatitis C virus (HCV) infection.~   "
82505|NCT02487017|"~     Evaluation of DC-CIK cells combined TACE treatment for HCC~   "
82506|NCT02487004|"~     The purpose of this study is to determine whether the change of serum and dialysate sodium~     level during hemodialysis can influence on blood pressure and intradialytic weight gain in~     chronic hemodialysis patients.~   "
82507|NCT02486991|"~     Thirty patients will be treated: 15 with a coronally positioned tunnel technique plus~     intramucosal verticals with AlloDerm® (test treatment) and 15 with a coronally positioned~     tunnel technique alone with AlloDerm® (control treatment). The surgical procedure for the~     control sites will consist of a coronally positioned tunnel preparation that is a~     modification of a previous tunnel technique described by Allen AL (Allen AL, 1994a/1994b).~     This tunnel technique was modified to include coronal positioning of the soft tissue over an~     allograft (E.P Allen). The surgical procedure for the test sites will consist of a coronally~     positioned tunnel preparation (E.P. Allen) plus the use of mesial and/or distal intramucosal~     verticals, a modification of the vestibular incision subperiosteal tunnel access (VISTA)~     approach (Zadeh H, 2011). Each patient will provide at least one Miller Class I or II facial~     recession defect, ≥ 3 mm. Patients will be randomly selected by a coin toss to receive either~     the test or control treatment. Three exams for measurements will be performed per patient on~     total: preoperative, at week eight and 16 (4 months) postoperatively. The primary aim is to~     compare the percent root coverage obtained with acellular dermal matrix using the coronally~     positioned tunnel technique alone or with intramucosal verticals.~   "
82508|NCT02486978|"~     Consumption of carbohydrate containing foods or sugary drinks brings about changes to the~     blood glucose levels. After a meal or drink, blood glucose rises until it reaches a peak~     concentration usually after 30 minutes. When the body senses the increase in blood glucose, a~     hormonal process involving insulin takes place to ensure that the glucose is taken up from~     the blood for storage and where it is needed for energy in the body. This process then brings~     about a decrease in the concentration of glucose until it reaches approximately the starting~     concentration. The original concentration of glucose is attained approximately 2 hours after~     eating or drinking a carbohydrate food or sugary drink respectively in healthy people.~      Different carbohydrates and sugary drinks have different effects on blood glucose response~     depending on the amount as well as the type of carbohydrate. Those that give rise to a high~     glucose response compared to a reference carbohydrate (usually glucose) are said to be high~     glycaemic index (GI) foods and those with a lower glucose response compared to a reference~     carbohydrate (usually glucose) are said to be low glycaemic index (GI) foods.~      Research has shown that diets that give rise to a high glucose response are associated with a~     number of abnormalities like increased risk of metabolic syndrome. Metabolic syndrome mostly~     comprises of insulin resistance and glucose intolerance which gives an increased risk of type~     2 diabetes. It also gives rise to other conditions like high blood pressure (arterial~     hypertension), elevated blood insulin levels (hyper-insulinemia), elevated amounts of fat in~     the liver (fatty hepatosis) and elevated amounts of lipids in the blood (dyslipidemia). After~     type 2 diabetes become clinically apparent, the risk of cardiovascular disease also rises.~     Research has also shown that foods/drinks which raise blood glucose levels gradually (low GI)~     rather than rapidly (high GI) have health benefits which include reducing the risk of~     metabolic syndrome. Laboratory studies have shown that polyphenols found in fruits,~     vegetables and plant based foods have a positive effect on carbohydrate metabolism and can~     lower the blood glucose levels.~      This research will determine whether the presence of polyphenols in the diet has any lowering~     effect on the blood glucose levels and hence the glycaemic index of foods. This will be~     determined by asking volunteers to consume commercially available food supplements together~     with white bread and then determining the glycaemic response. The blood glucose response of~     bread will be determined initially as a control reference. All will be consumed in random~     order.~      Analysis will be done by measuring blood glucose response after consumption of the control~     reference meal and the test meal containing polyphenols and then determining the incremental~     area under the glucose curve.~      POMEGRANATE AND OLIVE STUDIES WILL BE TREATED SEPARATELY FOR PURPOSES OF PUBLISHING RESULTS.~     EACH STUDY WILL AIM TO HAVE AT LEAST 16 PARTICIPANTS.~   "
82509|NCT02486965|"~     Fibromyalgia affects 1.4 now 2.2% of the general population whose symptom is the presence of~     widespread pain in all four quadrants of the body. Currently, there is no causal treatment of~     fibromyalgia syndrome.~      The aim of this study is the evaluation of a specific training program on controls of pain in~     fibromyalgia patients by balancing the stress axis.~      The primary endpoint is the improvement in the Visual Analogue Scale VAS difference) measured~     during the test of the thermode (difference between the average VAS measured between the 10th~     and 40th second of P1 and the average VAS measured between the 10th and 40th of the second~     P3) between D0 (3rd consultation) and M24 (5th consultation - end of study visit), which will~     be compared in the two groups..Salivary cortisol is also tested.~   "
82510|NCT02486952|"~     Evaluation of efficacy, safety profile and tolerability of rituximab (MabThera) in~     combination with chemotherapy in the treatment of Diffuse Large B-Cell Lymphoma (DLBCL).~     Participants, who were not treated previously for DLBCL, will receive MabThera in combination~     with Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone (CHOP) or CHOP-like~     chemotherapy according to registered indication. Patients will be followed up for safety and~     efficacy evaluation in accordance with routine practice. The study will be non-interventional~     and by its design purely observational. All treatments prescribed during the observation~     period will be at the treating physician's discretion and will be prescribed according to~     package labeling, within approved indication and local approval status of respective drugs.~   "
82511|NCT02486939|"~     An Open-label, Safety Extension Study (OLSES) evaluating the longer-term safety and~     durability of response of subjects who completed 48 weeks of evaluations in the confirmatory~     safety and efficacy studies, CHS 0214-02 or CHS-0214-04, evaluating CHS-0214 in patients with~     rheumatoid arthritis (RA) and plaque psoriasis (PsO), respectively.~   "
82512|NCT02486926|"~     Sevoflurane is widely and frequently used in pediatric anesthesia due to its non-irritating~     airway properties, rapid induction and emergence. However, it is associated with emergence~     agitation (EA) in children. EA may cause injury to the child or to the surgical site and is a~     cause of stress to both caregivers and families. Various pharmacologic agents have been~     suggested to reduce EA. But the effect of remifentanil on EA is still controversial. This~     study was designed to compare the effects of remifentanil and remifentanil combining~     alfentanil on EA in children undergoing ophthalmic surgery with sevoflurane anesthesia.~   "
82513|NCT02486913|"~     The investigators will develop a risk report within the primary care electronic health~     record (EMIS) for patients attending for their National Health Service Health Check. The~     value of the report for reducing cardiovascular risk will be assessed qualitatively and also~     quantitatively in a non-randomised comparative trial.~   "
82514|NCT02486900|"~     The study aims to examine whether the neurofeedback method (based on functional magnetic~     resonance imaging [fMRI]) can help patients with alcohol dependence to control their urges to~     drink alcohol and thus to remain abstinent. Potential effects of neurofeedback on abstinence~     and drinking behaviour will be evaluated based on the comparison between a group of patients~     receiving multiple sessions of neurofeedback training and a group of patients receiving~     treatment as usual over the same period of time.~   "
82515|NCT02486887|"~     The main objective of the study is to evaluate the effect of telemonitoring on mortality and~     rehospitalization due to heart failure on patients with chronic heart failure which have~     follow an educational program compared to a conventional follow-up during 1 year.~      The secondary objectives of the study are :~        -  Evaluate the cost of health~        -  Qualitatively evaluate telemonitoring on uses~        -  Evaluate quality of life~   "
82516|NCT02486874|"~     PoreSkin, a human acellular dermal matrix (hADM) manufactured by Faculty of Medicine,~     Chulalongkorn University, is the first human dermal substitute developed in Thailand. It is a~     permanent dermal substitute aiming to reduce skin contracture. The objective of this study is~     to assess the safety and ability in achieving durable and cosmetic coverage of PoreSkin.~   "
82517|NCT02486861|"~     The OCT-FORMIDABLE register will include with a retrospective fashion all consecutive~     patients that perform OCT on culprit and not culprit plaque in any subset in patients with~     ACS. Clinical and OCT data will be included in the register according to the dataset.The~     primary endpoint will be the correlation of OCT characteristics with incidence of major~     adverse cardiovascular events (MACEs defined as the composite of death from cardiac causes,~     non- fatal MI, clinically driven target vessel revascularization (TVR), or re-hospitalization~     due to unstable or progressive angina according to Braunwald Unstable Angina Classification)~     and clinical baseline characteristics.~      In particular subanalysis will be performed in the following subgroups: culprit plaque, not~     culprit plaque in culprit vessel, not culprit plaque in different vessel.~      Secondary end-point will be to evaluate how OCT analysis changed interventional cardiology~     approach in culprit plaque definition and coronary stenting respect the coronary angiography~     alone.~   "
82518|NCT02486848|"~     5% topical minoxidil is the maximum dosage approved by the US FDA for the treatment of female~     pattern hair loss. While topical minoxidil exhibits a good safety profile, the efficacy in~     the overall population is relatively low i.e., 30-40% re-grow hair.~      The primary purpose of this study is to assess if a higher dosage of topical minoxidil dosage~     (15%) will increase the number of responders among female subjects that have been identified~     through IVD testing as non-responders to 5% topical minoxidil.~   "
82519|NCT02486835|"~     Cough is a life saving reflex, therefore it is important, especially in pediatrics, to calm~     cough spells without sedating the reflex. The intent of this study is to use a protective~     syrup with does not act as a sedative or as a potent mucolytic and measure its efficacy and~     safety versus placebo in children with moderate to severe night and daily cough. Cough is~     assessed with a validated parent questionnaire. The degree of disturbance of cough is~     followed immediately after one night administration of the study products and daily for 4~     nights, 3 days.~   "
82520|NCT02486822|"~     This study aims to compare the novel labour scale with the traditional WHO partograph in the~     management of spontaneous labour in primigravida in terms of maternal and neonatal outcomes~   "
82521|NCT02486809|"~     This study will assess the bioequivalence in healthy participants between a~     high-concentration formulation of lebrikizumab withdrawn from a vial and administered SC as a~     single injection by a needle and syringe, and a low-concentration formulation of lebrikizumab~     administered SC as a single injection via PFS-NSD.~   "
82526|NCT02486744|"~     This will be a prospective observational study of Acthar Gel in Non-Diabetic Hemodialysis~     [NDHD] patients receiving dialysis for ≤ 2 years. The project will aimed at providing~     proof-of-concept data that 80 U two times [2x] week Acthar for 6 months is a safe and~     effective therapy for NDHD. Effectiveness of lower dose 40 U 2X week will also be determined.~     Therefore the study will be a repeated measures design (Time x condition) comparison of~     improvement in renal function, nutritional status, quality of life and physical performance~     resulting from Acthar therapy.~   "
82527|NCT02486731|"~     Noonan and LEOPARD syndromes share, with variable severity, different clinical traits,~     notably craniofacial manifestations, cardiopathies, short stature, and juvenile cancers.~      The main genetic cause of these syndromes is missense mutation of the gene encoding the~     ubiquitous tyrosine phosphatase Shp2, found in more than half the patients with NS and in 80%~     of LS cases. Shp2 plays pivotal roles in development, growth, and metabolism by regulating~     key signalling pathways (Ras/Mitogen activated protein kinase (MAPK), Phosphoinositide-3~     Kinases (PI3K)/Akt) in response to growth factors/hormones. Deregulation of these signalling~     pathways has been causally linked to NS and LS pathophysiology.~      This project aims at better understanding hormonal sensitivity abnormalities in patients with~     Noonan syndrome (NS) or LEOPARD syndrome (LS) caused by mutations of the tyrosine phosphatase~     Shp2.~      To reach this goal, the investigators will take advantage of different tissues (fibroblasts ±~     adipocytes) from patients with NS / LS compared to healthy controls.~      All patients will have a skin biopsy and only patients about to undergo surgery will have a~     adipose tissue biopsy.~   "
82528|NCT02486718|"~     This is a Phase III, global, multicenter, open-label, randomized study to compare the~     efficacy and safety of 16 cycles (1 cycle duration=21 days) of atezolizumab (MPDL3280A)~     treatment compared with best supportive care (BSC) in participants with Stage IB-Stage IIIA~     non-small cell lung cancer (NSCLC) following resection and adjuvant chemotherapy, as measured~     by disease-free survival (DFS) as assessed by the investigator and overall survival (OS).~     Participants, after completing up to 4 cycles of adjuvant cisplatin-based chemotherapy, will~     be randomized in a 1:1 ratio to receive atezolizumab for 16 cycles or BSC.~   "
82529|NCT02486705|"~     The proposed pilot study is designed to test the feasibility, acceptability, and potential~     effectiveness of a mobile phone application (app) developed by the VA National Center for~     PTSD (VA NCPTSD) for use by family members of those with Posttraumatic Stress Disorder~     (PTSD). The primary objective of the proposed study is to assess whether family members of~     veterans with PTSD find the PTSD Family Coach app to be satisfactory and feasible to use.~     Secondary objectives are to determine if use of the app increases family members'~     self-efficacy and their ability to manage their own life stress, which may in part be the~     result of living with someone who has PTSD.~   "
82530|NCT02486692|"~     The purpose of this study is to evaluate the AboutFace peer education website for the purpose~     of reducing stigma and improving attitudes toward seeking mental health services among~     Veterans.~   "
82531|NCT02486679|"~     A randomized controlled trial comparing labor induction with vaginal PGE2 tablets and foley~     catheter for cervical ripening.~   "
82532|NCT02486666|"~     Background Enoxaparin is a commonly used low molecular weight heparin (LMWH) for the~     treatment of neonatal thrombosis that is monitored with anti-factor Xa (anti-Xa) levels.~     However, this therapeutic range of anti-Xa (0.5 - 1.0 u/ml) was extrapolated from adult~     studies. The burden of pain to neonates due to venipunctures and of resources to the health~     care system also warrants a evidence-based review to assess the utility of monitoring LMWH~     therapy with anti-Xa levels. Here the investigators describe the FiXET trial.~      Methods/Design This is a prospective pilot, feasibility and safety multicenter, randomized~     controlled trial to compare the approach of treating thrombosis in neonates with enoxaparin~     using weight adjusted fixed dose to variable dose titrated to maintain a pre-determined~     anti-Xa range (0.5-1.0 u/mL). The investigators plan to recruit 20 neonates over a 6 month~     period, who will be randomized prior to their first anti-Xa level being resulted. Key~     feasibility outcomes include screening/:recruitment ratio, monthly recruitment rate, and~     completeness of data collection. The investigators will also measure the safety outcome of~     bleeding as well as comment on efficacy of resolution of thrombosis as a secondary outcome.~      Discussion The administration of weight adjusted fixed dose of enoxaparin without anti-Xa~     monitoring has the potential to reduce pain from multiple venipunctures in neonates as well~     as resources used in their already complex care. The results of the FiXET trial will set the~     framework for a larger multicenter randomized controlled trial to compare the efficacy of~     administering enoxaparin to neonates without monitoring to the current conventional approach~     of routine monitoring with anti-Xa levels.~   "
82533|NCT02486653|"~     The purpose of this study is to determine if tamsulosin (FLOMAX) is effective in preventing~     post-operative urinary retention following abdominal surgery. Post-operative urinary~     retention is a common post-operative complication, occurring in up to 30% of patients~     undergoing abdominal surgery. It can be described as the inability to initiate urination or~     properly empty one's bladder following surgery. It is usually self-limited, but it requires~     the use of catheterization to empty the bladder in order to prevent further injury to the~     bladder or kidneys and to relief the discomfort of a full bladder. Tamsulosin is a medication~     that is commonly used in men with urinary symptoms related to an enlarged prostate. There is~     some evidence to suggest that it may also potentially be beneficial for preventing~     post-operative urinary retention. Therefore, in this research study, subjects scheduled for~     abdominal surgery will be randomly assigned to take either tamsulosin once-daily or placebo~     once-daily for one week leading up to surgery, and up to several days after surgery. Urinary~     function will be assessed and compared between these two treatments. The hypothesis is that~     tamsulosin will reduce the rate of postoperative urinary retention compared to placebo.~   "
82534|NCT02486640|"~     This study aims to evaluate potential predictors of adherence by investigating a~     representative cohort of MS patients in Germany treated with Betaferon~   "
82535|NCT02486627|"~     This is a randomized, multicenter, multinational, double-blind study comparing the efficacy~     and safety of plazomicin compared with meropenem followed by optional oral (PO) therapy in~     the treatment of cUTI, including AP, in adults.~   "
83381|NCT02475590|"~     Prospective randomized clinical trial aiming to compare laparoscopic Roux-en-Y gastric bypass~     (RYGB) and sleeve gastrectomy (SG) with primary outcome on excess weight loss, and secondary~     outcomes on nutritional status, glycolipid profile, quality of life and pain assessments.~   "
82537|NCT02486601|"~     This is a non-randomized pauci-centre, open-label phase II study. The treatment will consist~     in a chemotherapy by FOLFOX and nab-paclitaxel following modalities determined in the Brown~     University Phase I study.~      In neoadjuvant setting : 3 months of treatment~      Main criteria of Withdraw of the treatment: in case of tumor progression, non acceptable~     toxicity, or patient decision.~      Post-operative treatment (for 6 additional cycles) is recommended, but will depend on the~     result of the neo-adjuvant treatment and the ability of patients to receive adjuvant~     chemotherapy based on tolerance of neo-adjuvant treatment and general post-operative~     condition (i.e. adjuvant treatment if no progression during neo-adjuvant chemotherapy, less~     than 80% of residual viable tumor compared to initial tumor volume, acceptable tolerance and~     post-operative PS 0 - 2). Adjuvant treatment must be initiated within 8 weeks~     post-operatively.~   "
82538|NCT02486588|"~     In collaboration with Vitality/Discovery in South Africa, an RCT amongst adult enrolled in~     the lowest tier of Vitality's HealthyFood benefit will be conducted. We will compare the~     effect of various messaging, and financial incentive strategies on healthy food purchasing~     behaviors in this population.~   "
82539|NCT02486575|"~     More than 50 residents in surgical specialities (OB&G, General surgery and Urology) from a~     single university in Italy will be randomized into two groups, after a stratification based~     on residency year and laparoscopic/simulator experience. The first one will train to FLS~     (fundamentals of laparoscopic surgery) following pre-recorded instruction from course~     materials; the second one will be mentored by a proctor in single training section. The aim~     is to evaluate the best way to train residents applying for the very first time in an~     extensive way the fundamentals of laparoscopic surgery program in an Italian Institution.~   "
82540|NCT02486562|"~     iConquerMS™ is a research initiative developed by and for people with multiple sclerosis (MS)~     to contribute their health data and ideas to advance and accelerate research into MS.~   "
82541|NCT02486549|"~     The purpose of this study is to compare the supraclavicular block to interscalene block in~     patients undergoing arthroscopic shoulder surgery.~   "
82542|NCT02486536|"~     The aim of this study is to evaluate the ideal dose of PEG and timing of bowel preparation in~     patients referred for CE examination.~   "
82543|NCT02486523|"~     The objective of the research is to assess the effectiveness of adding a Household WASH~     component to the standard outpatient treatment of severe acute malnutrition.~      Study design: cluster-randomized controlled trial comparing two interventions:~        1. Control group: outpatient management of children diagnosed for severe acute malnutrition~          only~        2. Intervention group: outpatient management of children diagnosed for severe acute~          malnutrition + household WASH package~      2000 children, aged between 6 and 59 months, admitted to 20 OTP (Outpatient Therapeutic~     Program) centers for SAM will be included into the study and followed for 8 months (2 months~     of treatment, and 6 months after successful discharge).~   "
82544|NCT02486510|"~     Effect on HIV-1 cell reservoirs of the concomitant administration of intensive chemotherapy~     and the pharmacological blockade of CCR5 coreceptors: a pilot, open, randomized, and~     controlled clinical trial.~   "
82545|NCT02486497|"~     Human equilibrative nucleoside transporter 1 (hENT1) is a membrane transporter which is a~     predicting marker for gemcitabine chemotherapy. However, there is a limited evidence of it as~     an indicator for adjuvant gemcitabine chemotherapy. In this study, investigators try to~     investigate the role of hENT1 as a indicator of selection of adjuvant chemotherapy regimen~     between gemcitabine and 5-fluorouracil (5-FU).~   "
82546|NCT02486484|"~     Background/aims: Aflibercept is an approved therapy for neovascular macular degeneration~     (AMD), diabetic macular edema (DME), retinal vein occlusion and other retinal conditions.~     Ziv-aflibercept is also approved by FDA and is extremely cost-effective relative to the~     expensive same molecule aflibercept. In vitro and in vivo studies did not detect toxicity to~     the retinal pigment epithelium cells using the approved cancer protein, ziv-aflibercept.~     Ziv-aflibercept had no loss of anti-VEGF activity when kept at 4°C in polycarbonate syringes~     over 4 weeks. Similar to bevacizumab, compounded ziv-aflibercept would yield a tremendous~     saving compared to aflibercept or ranibizumab. Phase I studies and case reports did not~     report any untoward toxic effects but attested to the clinical efficacy of the medication.~     Our purpose is to ascertain the long-term safety and efficacy in various retinal diseases of~     intravitreal ziv-aflibercept.~      Methods: Prospectively, consecutive patients with retinal disease that require aflibercept~     (AMD, DME, RVO, and others) will undergo instead the same molecule ziv-aflibercept~     intravitreal injection of 0.05 ml of fresh filtered ziv-aflibercept (1.25mg). Monitoring of~     best-corrected visual acuity, intraocular inflammation, cataract progression, and retinal~     structure by spectral domain OCT to be done initially, one month, 6 months, 1 year, and 2~     years after injections.~      Anticipated Results: Analyze signs of retinal toxicity, intraocular inflammation, or change~     in lens status, together with best corrected visual acuity and central foveal thickness at 1~     month, 6 months, 1 year and 2 year. Anticipated Conclusions: Off label use of ziv-aflibercept~     improves visual acuity without ocular toxicity and offers a cheaper alternative to the same~     molecule aflibercept (or lucentis), especially in the third world similar to bevacizumab.~   "
82547|NCT02486471|"~     Cytological abnormalities of the Cervix uteri need to be clarified by colposcopy biopsy. To~     avoid bleeding after biopsy, monsel´s paste is a common used Agent. In a randomized clinical~     Trial the use of monsel´s paste after biopsy will be compared to no Intervention. The Primary~     outcome of the study is blood loss, secondary outcomes are pain, satisfaction of the patient~     and influence of Independent factors such as Age and Body mass index.~   "
82563|NCT02486263|"~     The overall purpose of the investigator's study is to evaluate the causes of and treatment~     for feeding difficulty in infants with Gastro-esophageal Reflux Disease (GERD). New~     treatments can be possible only if the cause is known. Many infants have GERD and feeding~     difficulties, such as sucking and swallowing problems, vomiting, or delayed emptying of the~     stomach. Some of these infants have difficulty in protecting their airway during feeding or~     during reflux, and as a result can breathe fluid into their lungs or hold their breath. Most~     GERD treatments are done based on experience, but there is no scientific proof that these~     methods work for infants. GERD and feeding difficulties can lead to longer hospitalization~     and more stress for the family.~      In this clinical trial, the investigators are developing new methods to help with diagnosis~     as well as defining better treatment strategies in relieving GERD and GERD complications.~   "
82615|NCT02485574|"~     The purpose of this study is to evaluation for the pattern of bone bridging of patients who~     undergo transforaminal lumbar interbody arthrodesis, the investigators hypothesize that auto~     local bone mixed with β-calcium phosphate + hydroxyapatite (OSTEON 2, Genoss) is not inferior~     to auto local bone only. In addition, the investigators will analyze anterior new bone~     bridging pattern between anterior bridging cage newly developed and grafted bone in anterior~     disc space.~   "
82548|NCT02486458|"~     The anticaries effect of professional fluoride application has been associated with the~     formation of calcium fluoride-like products (CaF2) on dental surface, which may function as~     a slow release fluoride reservoir. Among professional fluoride products, fluoride gel and~     varnish are the most important, and have different soluble fluoride concentrations, pHs and~     vehicles. Although the concentration of fluoride formed on enamel after the use of both is~     similar, the retention of these reaction products is unknown. Also, it is unknown the~     capacity of these reservoirs to enhance dental biofilm fluid with fluoride. Moreover, the~     effect of the varnish application time on these parameters is unknown. Therefore, the aim of~     this study is to compare the capacity of fluoride gel and varnish to form fluoride reservoirs~     on enamel and increase dental biofilm fluid fluoride concentration with time. Rapid~     biofilm-forming individuals will be selected to participate and divided into 4 experimental~     groups: 1. Negative control: no treatment; 2. Varnish 4 hours: fluoride varnish will be~     applied and kept on teeth for 4 hours; 3. Varnish 24 h: fluoride varnish will be applied on~     teeth and kept for 24 h; and 4. Gel: Fluoride gel will be applied on teeth. Microbiopsies of~     enamel will be obtained by a microbiospy technique to assess fluoride concentration before, 7~     and 28 days after the treatments. Dental biofilm will be collected before and 3, 7, 14 and 28~     days after treatments. Fluoride concentration on enamel and in the biofilm fluid will be~     determined by an ion-specific electrode. Data will be analyzed statistically comparing the~     groups and collection times.~   "
82549|NCT02486445|"~     This prospective outcome study is designed to assess the safety of rivaroxaban in the~     pre-diagnosis phase of DVT.~   "
82550|NCT02486432|"~     A Single Period Investigation to Assess the Tolerability of Healthy Subjects to Oral Sinemet®~     (Levodopa/Carbidopa) Doses Administered Using a Divided Dose Approach~   "
82551|NCT02486419|"~     The primary objective in this study is to examine the seasonal variation in genetic markers~     in the deep neck adipose tissue in humans.~      Human adipose tissue biopsies are taken from patients admitted for elective surgery in the~     neck. During the surgical procedure a subcutaneous adipose tissue biopsy is taken for~     reference.~   "
82552|NCT02486406|"~     The purpose of this three part study is to evaluate the pharmacokinetics (Part 1),~     safety/efficacy (Part 2), and long-term follow-up (Part 3) of ombitasvir (OBV), paritaprevir~     (PTV), ritonavir (RTV) with or without dasabuvir (DSV) and with or without ribavirin (RBV) in~     pediatric subjects with genotype 1 or 4 chronic hepatitis C virus (HCV) infection.~   "
82553|NCT02486393|"~     The investigators conducted a prospective study of 132 patients undergoing benign parotid~     surgery at our department. Their primary objective was to analyze the incidence of and~     contributing factors associated with temporary and permanent postoperative facial palsy with~     strictly standardized methods in facial nerve function evaluation. Also other complications~     occurring within 12 months of operation were recorded.~   "
82554|NCT02486380|"~     This investigation is to evaluate the performance, comfort and ease of use of the Simplus and~     Eson masks amongst Obesity Hypoventilation Syndrome (OHS) patients in an overnight study.~   "
82555|NCT02486367|"~     The central hypothesis of this study is that TAVR leads to platelet deposition and~     inflammatory cell activation that can be attenuated by the potent anti-platelet and/or~     pleiotropic effects of ticagrelor.~      This single center, prospective randomized trial addresses the following specific aims:~        1. To determine whether high-potency ADP receptor blockade reduces measures of platelet~          activation in patients after TAVR.~        2. To determine whether high-potency ADP receptor blockade mitigates the pro-thrombotic~          inflammatory response observed after TAVR.~   "
82556|NCT02486354|"~     This study was a single-arm, multi-center, prospective, phase 3 trial aimed to evaluate the~     efficacy and safety of icotinib in patients with locally advanced or metastatic NSCLC after~     failure of at least one platinum-based chemotherapy regimen.~   "
82557|NCT02486341|"~     Basal insulin is widely used in older patients with diabetes. Human insulin Neutral Protamine~     Hagedorn (NPH) has been proposed as basal insulin in older (75 years or older) frail and~     dependent patients due to its shorter action. However, no study has analysed the glycaemic~     profile in elderly subjects according to the basal insulin used, particularly in frail or~     disabled patients.~      The aim of this study is to measure intra-day glycaemic variability according basal insulin~     (human NPH or long acting analogues) in older (75 and older) frail or disabled patients with~     diabetes using continuous glucose monitoring system.~   "
82558|NCT02486328|"~     There are different sedation regimes for lower GIS endoscopy which can be administered by~     anesthesiologists and non-anesthesiologists. This study aims to compare the effects of~     propofol/remifentanil combination and midazolam/meperidine combination on early cognitive~     function following lower GIS endoscopies.~   "
82559|NCT02486315|"~     The Axxess™ Biolimus A9™ Eluting Coronary Bifurcation Stent System (AXXESS System;~     Biosensors, International, Morges, Switzerland) is a dedicated bifurcation stent, designed to~     cover the lesion at the level of the carina. Although deemed ideal for lesions involving only~     the proximal MV (1,0,0 according to Medina classification ref), this device may be used also~     in more complex bifurcation lesions when additional DES are required in the distal MV and/or~     in the SB. In the present registry the investigators report the performance and the efficacy~     of the self-expanding biolimus-eluting AxxessTM stent for the treatment of bifurcation~     lesions in a real-world population.~   "
82560|NCT02486302|"~     The purpose of this non-interventional study is to evaluate the efficacy of etanercept during~     routine clinical use over a maximum of 12 months in patients with rheumatoid arthritis,~     psoriatic arthritis, axial spondyloarthritis, or plaque psoriasis. In so doing, particular~     attention will be paid to the proportion of those patients who only attain the desired~     treatment goal after 12 weeks of treatment. The primary efficacy end point for the study is~     the proportion of patients who attain the desired treatment goal after 12 and 24 weeks,~   "
82561|NCT02486289|"~     A randomized, placebo controlled, double blind proof of concept study of NBMI in treatment of~     mercury intoxication.~   "
82562|NCT02486276|"~     To develop a pragmatic migraine model the investigators will induce headache in healthy~     volunteers and in patients with migraine without aura with a phosphodiesterase inhibitor~     (cilostazol). If the headache responds to sumatriptan, the model can be used to test new drug~     candidates.~   "
82564|NCT02486250|"~     This is a five year study conducted in cooperation with the Brain Health Registry (BHR), an~     internet-based registry which enrolls individuals in Northern California in order to~     facilitate clinical trials for the prevention of Alzheimer's disease (AD). The investigators~     goal is to validate the Brain Health Registry's online cognitive measures developed by~     Lumosity. Investigators will meet this goal by collecting data from the newly developed the~     BHR online cognitive screening battery along with standardized measures of memory, attention,~     executive functioning and speed of information processing currently used in clinical trials~     for Alzheimer's disease.~   "
82565|NCT02486237|"~     Retrospective, observational study to determine the prevalence of complications in Central~     American diabetic patients.~   "
82566|NCT02486224|"~     Kona Deep is bottled water extracted from a depth of 3000 feet off the cost of Kona, Hawaii.~     Kona Deep claims that this unique source provides water that is naturally free of pathogens,~     chemicals and pollutants and rich in nutrients and minerals that are readily absorbed by the~     body. The investigators wish to examine Kona Deep's claim that this water is beneficial to~     the human body by testing the impact of drinking Kona Deep on exercise performance and~     recovery. Subjects will be exercised to a safe level of dehydration and then will be~     rehydrated with Kona Deep water, or commercially available bottled spring water or Gatorade~     as controls. Subjects will perform a simple exercise to evaluate peak power performance. This~     measurement will be compared between rehydration methods for significant differences.~   "
82567|NCT02486211|"~     This study evaluates if amantadine will increase the rate of awakening in patients~     resuscitated from cardiac arrest but comatose (not following commands) after their~     resuscitation. Half of the participants will receive amantadine and the other will receive~     placebo.~   "
82568|NCT02486198|"~     The purpose of this study is to determine whether Monosialotetrahexosylganglioside sodium~     injection can relieve the neurotoxicity caused by oxaliplatin in GI cancer.~   "
82569|NCT02486185|"~     Background to the research: Sarcopenia is a geriatric syndrome defined by progressive~     generalised loss of skeletal muscle, mass, force and function.~      Problem statement and objectives: To validate a simple, reproducible, screening tool, which~     is easy to use in the general practitioner's surgery is one of the challenges of the future.~      The primary objective is to assess the sensitivity and specificity of the study screening~     test, the SARC-F, at a predetermined threshold of >= 4. A total score of >=4 is associated~     with poor physical performance and is also predictive of the clinical diagnosis of the~     disease. The secondary objectives are to assess the prevalence of sarcopenia in the study~     population, to carry out a subgroup analysis of statistical performance for the five~     questions tested by the SARC-F, to identify the main risk factors associated with the disease~     and to propose an algorithm, positioning the SARC-F at the heart of a systematic screening~     process for the disease.~      Materials and methods: This is a diagnostic, cross-sectional study with a descriptive and~     analytical epidemiological component to analyse the secondary endpoints. It will be carried~     out in usual care over a period of 6 months in a homogeneous population of 65-year-old and~     older patients from the community consulting in primary care. The subjects will undergo the~     screening test (SARC-F questionnaire) and then the reference clinical assessment (gold~     standard) in succession.~      Expected results: To demonstrate the statistical tests that the SARC-F questionnaire is a~     simple tool, appropriate for early screening of sarcopenia in primary care.~   "
82570|NCT02486172|"~     This is a pre-and-post study with a study duration of one year involving 7 diabetes centres~     in Hong Kong. A group of motivated patients with type 2 diabetes will be trained as peer~     supporters in two training workshops. Patients who may benefit from peer support program will~     be recruited as peers. In the one year study period, peer supporters are required to have 2~     face-to-face interviews and 12 phone calls. Clinical parameters and psycho-behavioral~     parameters of both peer supporters and peers will be evaluated at the baseline and at the end~     of the study.~   "
82571|NCT02486159|"~     Using Oligonucleotide Chip Analysis, investigators compared gene expression levels in~     allergic rhinitis patients before and after a series of acupoint herbal plaster and~     Acupuncture treatment.~      In the first year, Twenty-three participants with persistent allergic rhinitis each received~     four acupoint herbal plaster treatments, applied using the moxibustion technique, and~     clinical outcomes were evaluated using the Rhinitis Quality of Life Questionnaire (RQLQ).~     Peripheral blood samples were analyzed using an ImmunoCAP Phadiatop test, and patients were~     classified as phadiatop (Ph)-positive or -negative. Microarray results were examined for~     genes that were differentially expressed between (1) Ph-positive and -negative patients~     treated with herbal paste; and (2) before and after herbal paste treatment in the Ph-positive~     patient group.~      In the second year, Twenty-seven participants with persistent allergic rhinitis each received~     four acupoint herbal plaster treatments and 8 courses of acupuncture treatment over 4 weeks~     in the same time.~   "
82572|NCT02486146|"~     The purpose of this study is to establish the working protocols for a general biorepository~     with the specific aim of procuring tissues and bodily fluids from the human gastrointestinal~     tract from a diverse range of clinical patients at the UC Davis Medical Center. The~     establishment of a GI-specific biorepository will support future translational endeavors~     within the UC Davis campus by providing laboratories with readily available GI tissue and~     bodily fluid samples to test newly developed hypotheses with relative ease.~   "
82573|NCT02486133|"~     A switch strategy to investigate whether a dual therapy with Ritonavir-boosted (RTV)~     Darunavir (DRV) + Dolutegravir (DTG) over 48 weeks is non-inferior to a continuous standard~     of care therapy with RTV-boosted DRV in combination with 2 Nucleosidic Reverse Transcriptase~     Inhibitors (NRTIs) in HIV patients, who are on a stable antiretroviral therapy (ART) with~     RTV-boosted DRV in combination with 2 NRTIs.~   "
82597|NCT02485808|"~     The purpose of this study is to advance our understanding of people who experience urinary~     and bladder problems. We are interested in learning about people's experiences with urinary~     symptoms and how these symptoms will be managed. We want to understand the important~     differences among people and what factors affect urinary and bladder problems. After all of~     the information is collected, we will have a better understanding of how to improve the care~     and treatment for people who have urinary and bladder problems.~   "
82574|NCT02486120|"~     Background:~      - Suicide is one of the main causes of death for adolescents in the U.S. The most effective~     way to decrease suicide is by training doctors to recognize the risk factors in their~     clients. One risk factor for suicide is chronic illness. So pediatric genetic counselors come~     across high-risk clients. But the suicide risk assessment (SRA) practices of these counselors~     are not well known. Researchers want to study learn more about this.~      Objectives:~      - To describe the practices, attitudes, and beliefs of genetic counselors about SRA of~     adolescents.~      Eligibility:~      - Genetic counselors who see adolescents ages 10 21~      Design:~        -  A study will be open to a listserv for genetic counselors.~        -  Participants will take a survey on their own.~        -  The survey will be online on a secure website.~        -  Participants will give data about themselves. This can include age, gender, job, etc.~        -  The survey will be about 60 questions.~        -  The survey will take around 20 25 minutes.~        -  The questions are about participants experiences, practices, attitudes, and beliefs~          about SRA.~   "
82575|NCT02486107|"~     In case of cervical foraminal stenosis without central stenosis, there are several options;~     anterior discectomy and fusion (ACDF), tubular retractor assisted micro-foraminotomy (MTPF)~     and posterior percutaneous cervical foraminotomy and discectomy (P-PECD). P-PECD is a modern~     technique and there was no RCT with MTPF, although P-PECD showed not inferior result to ACDF.~     Nowadays MTPF and P-PECD are minimally invasive surgical techniques, but there was no~     comparative study.~      The primary object of the study is to compare radiological outcome (segment angle) after MTPF~     or P-PECD.~   "
82576|NCT02486094|"~     This study tests biopsy and tissue from patients who have been treated for primary rectal~     cancer at the Royal Marsden Hospital between 2011 and 2013, who have an mrTRG score at~     post-chemoradiotherapy MRI. It is a retrospective pilot study to determine the apoptotic and~     proliferative index count pre and post chemoradiotherapy.~   "
82577|NCT02486081|"~     Children with disabilities are frequently ignored by the general population, hence the~     development of movement evaluation and training devices for use in special education settings~     are relatively overlooked. Usually the performance of these children is not stable and~     contains variations. Hence in order to get a complete picture of their sport performance,~     simply measuring movement time and distance is definitely not representative. With the rising~     attention from government regarding fitness and social participation of the disabled in~     recent years, developing a special-designed individual evaluation & training plan is of great~     importance. To achieve this goal, a device which is able to record the complete process of~     movement, and contains algorithm that can pick up the movement characteristics of children~     with disabilities is needed. The purpose of this study is to design and develop a smart~     soccer ball system for use in children with intellectual disabilities(ID), and to compare the~     performance between children with ID and the typically developed.~   "
82578|NCT02486068|"~     The primary objectives of this trial are:~      In patients at high-risk for restenosis,~        -  To assess non-inferiority of the everolimus-eluting bioresorbable scaffold (BRS) to the~          everolimus eluting cobalt chromium metallic stent (EES) in target lesion failure (TLF)~          at 1 year~        -  To assess superiority of the BRS to the EES in TLF between 1 and 5 years~   "
82579|NCT02486055|"~     This is an open-label, Phase I study of the bioavailability and safety of BPM31510 in healthy~     subjects dosed 2 or 3 times daily for 4 days, after an initial cohort of 6 subjects receiving~     a single dose (pre-study cohort). The pre-study cohort subjects will receive 1600 mg as a~     single administration. Cohort 1 and Cohort 2 will consist of 10 patients each. The cohorts~     may be enrolled sequentially.~   "
82580|NCT02486042|"~     Retinopathy of prematurity (ROP) is a blinding disease affecting infants born prematurely.~     These infants do not have enough essential fatty acids to structurally support the retina,~     the nerve tissue in the eye which allows us to see. A recent study showed that giving omega-3~     (n-3) fatty acids to these infants soon after birth made them less likely to need invasive~     treatments for eye disease. This research trial will give young infants born prematurely n-3~     fish oil treatment and look at how this changes factors in the blood that promote disease.~     Detailed blood studies comparing infants with and without ROP will be performed and the~     infants will be followed over time to assess their eye development.~   "
82581|NCT02486016|"~     This is an Open-label, Non-Randomized, 3-way Crossover Bioequivalence Study to compare~     fentanyl release after heating of a brand name (Duragesic) and generic (Apotex and Mylan)~     fentanyl skin patches in healthy adults.~   "
82582|NCT02486003|"~     This study will assess the effectiveness of a portable goggle system in the diagnosis of mild~     traumatic brain injury (mTBI) in athletes.~   "
82583|NCT02485990|"~     This study will be looking at what dose of tremelimumab and olaparib is safe and effective in~     patients with persistent EOC (Epithelial Ovarian, Fallopian Tube or Primary Peritoneal~     Carcinoma).~   "
82584|NCT02485977|"~     The overall goal of this study is to evaluate agreement between cardiac MR parameters and~     well-established clinical and catheterization parameters of poor prognosis in patients with~     pulmonary hypertension. The identification of noninvasive cardiac MR techniques to evaluate~     myocardial disease in patients with pulmonary hypertension would be beneficial to society due~     to the potential to replace serial invasive cardiac catheterization procedures with a~     noninvasive imaging test.~   "
82585|NCT02485964|"~     To measure antigen-specific interferon-secretion by enzyme-linked immunospot (ELISPOT) assay,~     which measures antigen-specific interferon-secretion.~   "
82598|NCT02485795|"~     The purpose of this study is to evaluate the impact of genetic testing on healthcare~     decisions and patient outcomes in interventional pain management clinical care. Results of~     genetic testing will also be compared with the clinical outcome measures collected to~     discover novel genetic factors that may influence patient care.~   "
82599|NCT02485782|"~     Changes in volumetric hemodynamic parameters and fluid overload (Cardiac Index,Stroke Volume,~     Thoracic Fluid Content, Systemic Vascular Resistance) were measured using a impedance~     cardiography (ICG) (CardioScreen 1000 - Haemodynamic Measurement System, Medis. GmbH Ilmenau)~     beginning 15 min prior to midweek dialysis session and continuous measurement thereafter,~     with a 15-min period after the termination of hemodialysis. Fluid overload were measured by~     BCM Monitor Fresenius before hemodialysis.~   "
82586|NCT02485951|"~     Different techniques of deep anterior lamellar keratoplasty (DALK) have been introduced to~     create a uniform recipient bed, thereby reducing complications, such as interface~     irregularity and opacification encountered with conventional lamellar keratoplasty. The~     big-bubble technique provides a planned, safe, quick and consistent baring of Descemet~     membrane (DM) by injection of air deep into the stroma. Nevertheless, this technique has a~     long learning curve with a low success rate of big-bubble formation and a high rate of DM~     perforation when performed by surgeons in training. Different modifications to the original~     technique using intraoperative instruments such as corneal pachymetry, anterior segment~     optical coherence tomography (OCT), and femtosecond laser, have been used to increase the~     chances of achieving a successful DM detachment from the deep stroma by air injection. Even~     with these innovations, the rate of successful big-bubble formation did not reach 100%.~     Recently, the investigators described a modification to the original big-bubble DALK in which~     a 27-gauge needle was inserted into the stroma peripherally from the trephination site~     towards the limbus. The investigators found that air injection peripheral to the trephination~     can effectively and reproducibly separate the corneal stroma from the Descemet membrane (DM).~     This study was aimed to compare the success rate and complications of big-bubble DALK using~     central versus peripheral air injection performed by senior cornea fellows under the~     supervision of an experienced faculty member in an academic hospital.~   "
82587|NCT02485938|"~     Male subjects with cardiomyopathy secondary to Duchenne muscular dystrophy (DMD) meeting all~     inclusion and no exclusion criteria will be randomized. All subjects will be at least 12~     years of age. They will be randomized in a 1:1 manner to either intracoronary infusion of~     CAP-1002 in three coronary arteries supplying the three major cardiac territories of the left~     ventricle of the heart (anterior, lateral, inferior/posterior) or usual care. In the active~     treatment arm, all three major cardiac territories will be treated (infused) during a single~     procedure in an open-label fashion.~   "
82588|NCT02485925|"~     This is a prospective effectiveness and safety assessment of the study device during~     radiofrequency (RF) ablation treatment of patients with drug refractory symptomatic atrial~     fibrillation.~   "
82589|NCT02485912|"~     This is a clinical trial in which healthy volunteers will be administered two experimental~     Ebola vaccines: ChAd3-EBO Z and MVA-EBO Z. Two groups of volunteers will be vaccinated with~     both vaccines one after the other in a prime/boost regimen.~      All ChAd3-EBO Z doses are 2.5 x 10^10 - 3.7 x 10^10 vp and all MVA-EBO Z doses are 1.0 x 10^8~     pfu.~      All volunteers will receive a ChAd3-EBO Z priming vaccine and a MVA-EBO Z boosting vaccine 7~     days later.~      The site of administration of the MVA-EBO Z vaccine differs between the two groups:~      Group 1 will receive the MVA-EBO Z vaccine in the same arm as the ChAd3-EBO Z vaccine.~      Group 2 will receive the MVA-EBO Z vaccine in the opposite arm from the ChAd3-EBO Z vaccine.~      The study will assess the safety of the vaccinations, and the immune responses to~     vaccination. Immune responses are measured by tests on blood samples.~      The ChAd3-EBO Z and MVA-EBO Z vaccines are called viral vectored vaccines. They are made from~     viruses which are modified so that they cannot multiply. The viruses have extra DNA in them~     so that after injection, the body makes Ebola proteins (but Ebola does not develop), so that~     the immune system builds a response to Ebola without having been infected by it.~      Healthy volunteers will be recruited in Dakar, Senegal. The study will be funded by GSK.~   "
82590|NCT02485899|"~     The Phase 1/2 study (190-201) evaluated the efficacy and safety of doses up to 300 mg/every~     other week (qow) BMN 190 in patients with CLN2. The dose and regimen for this study (190-202)~     are based on the results of the 190-201 study. The rationale for this phase 2 extension study~     is to provide patients who complete the 190-201 study with the option to continue to receive~     continued BMN 190 treatment. The 190-202 study is an open label extension protocol to assess~     long-term safety and efficacy.~   "
82591|NCT02485886|"~     Inflammation mediated by macrophage infiltration plays a vital role in a diverse range of~     physiological conditions. In particular, recent evidence suggests this type of macrophage~     response is important for the disease pathology of pulmonary fibrosis. Because cysteine~     cathepsins are proteases that are highly expressed in antigen presenting cells such as~     macrophages, they serve as promising biomarkers. Employing non-invasive imaging agents~     68Ga-BMV101 that specifically recognize cysteine proteases in immune cells has the potential~     to not only aid early detection but also significantly aid efforts to monitor progression and~     patient response to therapy.~   "
82592|NCT02485873|"~     To obtain a better understanding on the comparative effectiveness of rivaroxaban and vitamin~     K antagonists (VKA) for stroke prevention in patients with non-valvular atrial fibrillation~     (SPAF) in a real-life setting~   "
82593|NCT02485860|"~     The management of pilonidal cysts is a skin excision and under deep skin. Scarring requires~     regular dressings (daily for 15 days and then every 48 hours) until complete healing. This~     healing is obtained on average in 68 days. Some patients have difficulties in healing with a~     final healing achieved on average in 95 days. Some teams use honey to promote wound cavitary~     wounds (wound infection, pressure ulcers, varicose wound). The acceleration of wound healing~     is due to antibacterial properties and hyperosmolarity to reduce secretions. ) The use of~     honey in pilonidal cysts is not evaluated and may accelerate healing.~   "
82594|NCT02485847|"~     The IRIS™ Registry (Intelligent Research in Sight) is the nation's first comprehensive eye~     disease clinical registry. The American Academy of Ophthalmology is developing it as part of~     the profession's shared goal of continual improvement in the delivery of eye care.The IRIS~     Registry will be a centralized system for ophthalmology practices to promote practice~     innovations and achieve clinical excellence.~   "
82595|NCT02485834|"~     This randomized phase II trial studies how well fludeoxyglucose F-18 (FDG)/positron emission~     tomography (PET) directed treatment improves response in patients with stomach or~     gastroesophageal junction cancer that has not spread past the stomach and is not responding~     to the usual treatment. PET scans are a different way to take pictures of cancer and can be~     used to look at how much energy (such as glucose) is being used by the cancer. Using PET~     scans early to monitor the success of treatment may allow doctors to measure response and~     change treatment accordingly.~   "
82596|NCT02485821|"~     To assess the effect of vaginal estradiol pretreatment before vaginal misoprostol on labor~     induction.~   "
82601|NCT02485756|"~     Previous studies have shown that women on anti-seizure medications are not informed about the~     pharmaceutical drug interactions between anti-seizure medications (antiepileptic drugs, AEDs)~     and certain hormonal contraceptive. The goal of this proposed study is to develop and assess~     the efficacy of an educational handout for participants on the ways AEDs and certain hormonal~     contraceptives can interact to alter effectiveness of the medications. Reproductive age women~     (18-45 years old) will be recruited from UCSD Health System Epilepsy clinics. If a patient~     agrees to participate, she will be given a knowledge exam prior to the clinic appointment to~     establish baseline understanding of hormonal contraceptive and AED interactions and then the~     participant will be randomized to receive the intervention (educational handout) or the~     standard of care (no educational handout). Those in participants in the intervention group~     will read an educational handout on hormonal contraceptives/AED interactions. Those in the~     standard care group will not receive this handout and the same knowledge exam will be~     re-administered to all of the participants after they have completed their appointments to~     check for knowledge comprehension and short-term knowledge retention. A same-day post-test~     questionnaire will evaluate participant's intention to discuss hormonal contraceptives/AED~     interactions with their gynecologist, neurologist or primary care physician.~   "
82602|NCT02485743|"~     This multi-centre, randomised controlled trial will be conducted over 24-weeks to evaluate~     the effect of a healthy diet supplemented with a product specifically developed (SATIN~     satiety products) to enhance feelings of satiety and reduce food intake after an initial~     weight loss period to assess weight maintenance. Participants will either receive the active~     SATIN product or a matched control product. The products contain ingredients which have been~     shown to positively affect satiety, satiation and/or body weight and are all accepted food~     ingredients approved for human consumption in Europe. They will be incorporated into~     different food matrices, e.g. drinks, shakes and cheeses. Corresponding control products~     without the active ingredients will be provided to participants allocated to the control~     group. The participants will be instructed in detail on how and when to consume the test~     products. Participants will be 300 adults (BMI >27kg/m2; Age>18years) who will be tested at~     three research sites (University of Liverpool, United Kingdom; University of Copenhagen,~     Denmark and University Rovira I Virgili, Spain). Recruitment will be divided between sites.~     Participants will attend assessments at one of the three research sites continually~     throughout the study period. The primary outcome will be weight maintenance after low calorie~     diet as assessed by weight, waist circumference, body composition (DXA), energy intake and~     subjective appetite assessments made at study test sessions. Secondary outcomes include~     assessing biomarkers of health outcomes (blood and urine indices), changes in physical~     activity as well as consumer benefits of the trial (assessed in a range of questionnaires) to~     determine diet efficacy.~   "
82603|NCT02485730|"~     The ALFA study is a long term, prospective, observational study of AD patients' adult~     children aimed at studying and characterizing key physio-pathological features of the~     preclinical phase of AD.~   "
82604|NCT02485717|"~     To assess the safety and efficacy of Natroba (spinosad) topical suspension versus placebo for~     the clinical cure of scabies after a single treatment. The trial will also assess the~     pharmacokinetics (PK) of spinosad and benzyl alcohol following a single dose of Natroba™ in~     pediatric subjects 4-16 years of age. These subjects will be a separate population of~     pediatric subjects.~   "
82605|NCT02485704|"~     To assess the safety and efficacy of Natroba (spinosad) topical suspension versus placebo for~     the complete cure of scabies after a single treatment.~   "
82606|NCT02485691|"~     Primary Objective:~      To compare the radiographic progression-free survival (rPFS) of chemotherapy (cabazitaxel~     plus prednisone, Arm A) versus AR-targeted therapy (enzalutamide or abiraterone acetate plus~     prednisone, Arm B) in mCRPC patients who have been treated with docetaxel and who had disease~     progression while receiving AR-targeted therapy within 12 months of AR treatment initiation~     (≤12 months, either before or after docetaxel).~      Secondary Objectives:~        -  To compare efficacy for:~        -  Prostate-specific antigen (PSA) response rate and time to PSA progression (TTPP).~        -  Progression-free survival (PFS).~        -  Overall survival (OS).~        -  Tumor response rate and duration of tumor response.~        -  Pain response and time to pain progression.~        -  Symptomatic skeletal event (SSE) rate and time to occurrence of any SSE.~        -  Health status and Health-related Quality of Life (HRQOL).~        -  To evaluate the correlation of a signature of resistance to AR-targeted agents with~          clinical outcome via the analysis of circulating tumor cell (CTC) phenotypes as well as~          expression and localization of proteins including AR isoforms in CTCs.~        -  To evaluate safety in the 2 treatment arms.~   "
82607|NCT02485678|"~     Comparison of the number of ER plus hospital visits that occurred during chemotherapy between~     the telephone intervention and control arms.~   "
82608|NCT02485665|"~     To evaluate the efficacy of postoperative pelvic floor muscle training using personalized~     extracorporeal biofeedback device among patients with post-prostatectomy incontinence~   "
82609|NCT02485652|"~     The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of HM61713~     in patients with T790M-positive non-small cell lung cancer (NSCLC) after treatment with an~     epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI).~   "
82610|NCT02485639|"~     The primary objective investigate the longevity of humoral immunity to influenza virus in~     humans. Our overarching hypothesis is that an understanding of how long-term humoral immunity~     to influenza virus is generated and maintained is essential for the development of a~     universal vaccine against influenza virus. The secondary objective is the longitudinal~     tracking of vaccine-induced B cells responses with special emphasis on broadly neutralizing~     HA stem reactive responses.~   "
82611|NCT02485626|"~     The purpose of this study is to evaluate the prevalence of (sub)clinical cardiovascular~     disease, cardiovascular risk factors and metabolic abnormalities among long-term breast~     cancer survivors treated with or without anthracyclines in order to identify patients at~     increased risk of developing cardiovascular disease.~   "
82612|NCT02485613|"~     Although the use of bortezomib has reported efficacy in amyloid light chain (AL) amyloidosis,~     the role of bortezomib with dexamethasone (BD) in the first-line treatment of patients with~     AL amyloidosis should be determined. In this study, the investigators evaluated the efficacy~     and safety of BD as the first-line treatment of patients with AL amyloidosis.~   "
82616|NCT02485561|"~     This is a study examining the effects of different educational-motivational materials about~     colorectal cancer screening on perceptions and intentions to get screened. Eligible~     participants will be randomized to one of three experimental conditions. All participants~     will be provided information about colon cancer and screening options based on the Centers~     for Disease Control and Prevention (CDC's) Screen for Life materials. Some participants also~     will be asked to read a personal narrative about colon cancer screening. This study will~     determine whether participant's perceptions about and colorectal cancer screening intentions~     and behaviors differ by which information they read. Participants will complete surveys~     before, immediately after, and one month after randomization. Participants can complete all~     study requirements through the study website: http://HealthStudy.wustl.edu~   "
82617|NCT02485548|"~     This study is a multicenter phase Ⅲ trial. The objective is to compare the efficacy and~     toxicity of cisplatin plus raltitrexed or 5-fluorouracil in concurrence with IMRT for~     patients with locoregionally advanced head and neck squamous cell cancer.~   "
82618|NCT02485535|"~     This phase I trial studies the side effects and best dose of selinexor when given after stem~     cell transplant in treating patients with acute myeloid leukemia that is at intermediate or~     high risk of spreading or coming back (intermediate- or high-risk), or myelodysplastic~     syndrome that is at high risk of spreading or coming back (high-risk). Selinexor works to~     stop cancer growth by blocking an enzyme, which may cause cancer cells to die and also kill~     cells that cause the cancer to grow, which commonly do not respond to regular chemotherapy.~   "
82619|NCT02485522|"~     Fecal Incontinence (FI) is a debilitating and common condition with a prevalence ranging from~     7-15% in community dwelling women. FI has an immense impact on quality of life and is~     associated with increased care giver burden, increased rates of institutionalization, and~     significant cost burden in older women. Traditionally believed to be primarily caused by~     child birth injury, recent studies show that the typical age of onset of FI is age 40 which~     is remote from child birth. Treatment options for FI are limited because the mechanism~     underlying FI in older women are poorly understood. The overriding goal of this project is to~     investigate the relationship between diet, stool metabolites and fecal incontinence.~   "
82620|NCT02485509|"~     A combined Phase Ib and IIa randomized, placebo-controlled, double-blind study of VM-1500 in~     healthy subjects and in patients with HIV-1 infection that are antiretroviral therapy naïve.~   "
82621|NCT02485496|"~     The purpose of this study is to evaluate clinical and technical success as well as safety and~     feasibility of the E-tegra Stent Graft System used in endovascular treatment of infrarenal~     aortic aneurysm.~   "
82622|NCT02485483|"~     The purpose of this study is to validate standardized questionnaires on depression for RA and~     to investigate the frequency of depression with RA. The study will include 2 parts, VADERA I~     and VADERA II. In VADERA I, 300 participants will be surveyed twice at an interval of 3~     months regarding their current emotional condition using standardized questionnaires. On the~     basis of the results of VADERA I, in VADERA II, the selected questionnaire will be used to~     assess the prevalence of depression with RA in approximately 1000 participants.~   "
82623|NCT02485470|"~     The goal of this study is to test, in a randomized controlled trial among head and neck~     cancer patients, the short and longer term effects of the MPACT (Maintaining Physical~     Activity during Cancer Treatment) program (infused with motivational interviewing and~     self-determination theory-based strategies) initiated at the time of concurrent chemotherapy~     with radiation (CCRT), on key outcomes such as functional mobility and quality of life, and~     ultimately physical activity. The central hypotheses is that in head and neck cancer patients~     undergoing CCRT, the MPACT program, as compared to usual care controls, will result in less~     acute decline, faster recovery, and better maintenance of these key outcomes.~   "
82624|NCT02485457|"~     The purpose of this study is to evaluate the ability of NICOM (Noninvasive cardiac output~     monitor) to detect stroke volume variation induced by leg raising or fluid expansion during~     surgery~   "
82625|NCT02485444|"~     This study compares oxytocin infusion to spontaneous follow-up for third-stage of labor at~     induced mid-trimester abortions. Patients will be randomized to oxytocin infusion or~     observation with no pharmacologic intervention. Primary outcome of the study is complete~     abortion rate within two hours of fetal delivery.~   "
82626|NCT02485431|"~     This is a Phase 1, single-center, single-dose, randomized, 5-period crossover study designed~     to assess the comparative bioavailability and food effect of deflazacort. A total of 45~     subjects will be randomly assigned to receive 1 of 5 treatment sequences. Each dosing~     sequence will be enrolled in parallel and all subjects will receive all 5 treatments in a~     crossover fashion.~   "
82627|NCT02485418|"~     Propofol has been used in adult populations to treat migraines as an abortive agent.~     Investigators plan to investigate its efficacy as an abortive agent in the pediatric~     population when administered as a safe low-dose infusion. Goals of the study are to:~        1. Evaluate efficacy of low-dose propofol infusion as an abortive agent in pediatric~          migraine headaches~        2. Evaluate effective and safe dosing limits in pediatric populations~        3. Evaluate duration of effect reached from a low-dose propofol infusion as an abortive~          agent~      Endpoints for the study will be:~        1. Number of enrolled patients~        2. Safety endpoints reached, including: cardiopulmonary depression, excessive somnolence~          Risks of the study are minimal due to the use of sub-anesthetic dosing of propofol under~          the guidance and supervision of a board certified pediatric anesthesiologist with the~          appropriate monitoring equipment and readily available emergency equipment.~          Investigators hope to demonstrate more rapid improvement and decreased side-effect as~          compared to standard care.~   "
82628|NCT02485405|"~     The purpose of this study is to analyse gut permeability and stress.~   "
82629|NCT02485392|"~     A single-blinded randomized clinical trial (RCT) designed to compare Single-Site~     robot-assisted with single-incision laparoscopic cholecystectomy. The study directly compares~     both surgical approaches in a cohort of 60 patients (30 patients in each arm) with benign~     gallbladder disease from the Department of Surgery at the Cantonal Hospital of Winterthur~     (Kantonsspital Winterthur) in Switzerland. The primary endpoint of the study is the surgeon's~     physical and mental stress load at the time of surgery and is assessed by validated Local~     Experienced Discomfort (LED) and Subjective Mental Effort Questionnaire (SMEQ) visual~     analogue scales. The secondary endpoints include costs of the procedure, intra-operative~     blood loss, operating time, intra-operative conversion rate and additional trocar placement,~     complications, length of hospital stay, Health-Related Quality of Life (HRQoL) and cosmesis.~     HRQoL and cosmesis will be assessed using the validated Gastrointestinal Quality of Life~     Index (GIQLI) and the Body Image Questionnaires (BIQ), respectively. The inclusion criteria~     cover most notably symptomatic cholecystolithiasis, chronic cholecystitis, benign gallbladder~     polyps and age ≥18 years. The exclusion criteria are, among others, acute cholecystitis,~     emergency cholecystectomy, previous extensive upper abdominal surgery and suspicion of~     malignant disease. Non-stratified block randomization (random block sizes 2 and 4) will be~     used to achieve balance in the allocation of participants to both treatments arms and prevent~     a premature decoding of the randomization scheme. Hereby, the patient will not be informed~     about the group assignment until the last outpatient follow-up and only after he/she has~     completed and returned all required questionnaires (GIQLI and BIQ). The operation will be~     performed according to the group assignment by senior surgeons only who have a wide~     experience in both robotic Single-Site and conventional single-incision laparoscopy. All data~     are recorded safely using the SecuTrialTM program. Sample-size calculations are based on the~     results of the previously mentioned experimental setup by Schatte et al, utilizing an~     estimated effect size of 0.8, at a power of 0.8 and an alpha-error level of 0.05, as well as~     considering a potential additional error margin of 10-15% of the calculations (G-Power 3.1~     software, Heinrich-Heine University Duesseldorf/Germany). The estimated total duration of the~     study is 1.5 years, including the scheduled 1-month and 1-year postoperative follow-up~     visits. The study will be carried out in accordance with principles enunciated in the current~     version of the Declaration of Helsinki, the guidelines of Good Clinical Practice (GCP) issued~     by International Conference on Harmonization (ICH), and Swiss regulatory authority's~     requirements.~   "
82674|NCT02484807|"~     The development of disease-targeted medication for the treatment of pulmonary arterial~     hypertension (PAH) has significantly improved within the last years, leading to the~     development of 10 approved agents. Combination treatment with Endothelin-Receptor-Antagonists~     (ERA) and Phosphodiesterase-Type-5-Inibitors (PDE-5-Inhibitor) has become increasingly~     important for the treatment of PAH. In a recent press release, the results of the AMBITION~     study reported that an upfront combination treatment immediately after diagnosis leads to a~     delayed disease progression [4]. Thus, the question if there is a clinically relevant~     pharmaco-dynamic drug-drug interaction is of rising interest.~   "
82630|NCT02485379|"~     Background: Prostate cancer is difficult to detect using ultrasound. As a result, in case of~     suspicion of prostate cancer based on digital rectal examination (DRE) or Prostate Specific~     Antigen (PSA) level, it is currently recommended to perform blinded systematically~     distributed biopsies with 10-18 samples obtained from predefined locations in the gland.~      These so-called systematic biopsies (SB) may lead to improper patient management by (i)~     missing clinically significant cancer, especially in the anterior half of the gland that~     tends to be undersampled, (ii) inducing chance detection of clinically insignificant cancer~     foci that may result in overtreatments, (iii) undersampling the tumor foci and thus~     underestimating their volume and aggressiveness.~      Multiparametric Magnetic Resonance Imaging (mp-MRI) has yielded promising results in~     detecting aggressive (Gleason ≥7) prostate cancers. Several monocenter studies showed that~     targeted biopsies (TB) based on mp-MRI findings could detect significantly more aggressive~     cancers, reduce the diagnosis of clinically insignificant cancers, and better evaluate the~     aggressiveness of detected cancers than SB. However, these monocenter studies only provide~     low-level evidence and three recent independent reviews of literature concluded that there~     was a need for a robust multicenter trial evaluating the diagnostic yield of TB as compared~     to SB. This is particularly important since many academic and private centers in France~     already perform mp-MRI before prostate biopsy in daily routine. Therefore the risk is that~     this approach becomes the norm without being properly evaluated and it is crucial and urgent~     to perform a controlled multicentric study to provide high-level evidence as to whether~     mp-MRI should or should not be obtained before prostate biopsy.~      One controlled multicentric study has been published recently in which SB and TB had been~     obtained by two different operators in 95 patients. TB yielded a significantly higher~     detection rate for all prostate cancers (69% vs 59%, p=0.033) and for clinically significant~     cancers (67% vs 52%, p=0.0011). However, this study was limited by the fact that patients~     with negative mp-MRI were not included.~      Research hypotheses: There is currently no robust multicenter trial comparing prostate TB~     based on mp-MRI findings versus the current standard of care (SB). We propose a multicentre~     prospective trial comparing the results of SB and TB performed in the same patients by two~     independent operators. Our hypothesis is that TB detects aggressive (Gleason ≥7) cancers in a~     significantly higher percentage of patients than SB.~      Main objective: To compare the percentage of patients with clinically significant cancer~     (using definition A, i.e. cancer with Gleason score ≥7) detected by SB versus TB.~   "
82631|NCT02485366|"~     Blood transfusion is nearly always needed during open heart surgery in children less than 15~     kg (35 pounds). The purpose of the red blood cells in the blood is to deliver oxygen to the~     organs and tissues of the body. Stored blood undergoes some changes that may make it less~     effective in achieving this goal. The purpose of this study is to see if restoring important~     energy molecules (ATP and 2,3,DPG) in stored red blood cells before they are transfused, with~     a rejuvenating solution (Rejuvesol), offers any advantages to children over standard blood~     transfusion. This is a Food and Drug Administration (FDA) approved process that is described~     by the American Association of Blood Banks for prolonging blood storage but not used for~     everyday transfusions. The investigators want to use this process to improve blood transfused~     to children undergoing heart surgery.~      Although Rejuvesol has been previously approved by the FDA, it is not routinely used to~     prepare standard blood transfusions to children undergoing surgery. Use of Rejuvesol in this~     study is considered investigational. This is a pilot study and data will be collected for~     future protocol development.~   "
82632|NCT02485353|"~     This is a pilot efficacy assessment clinical trial of vosaroxin and cytarabine for the~     treatment of adults 60 years of age or older with previously untreated acute myeloid~     leukemia. A total of 17 evaluable patients are planned to be treated on the study.~   "
82633|NCT02485340|"~     To develop a pragmatic migraine model the investigators will induce headache in healthy~     volunteers and in patients with migraine without aura with a long lasting Nitrogen Oxide (NO)~     donor. If the headache responds to sumatriptan, the model can be used to test new drug~     candidates.~   "
82634|NCT02485327|"~     Primary Objective:~      To characterize the within-subject variability in systemic exposure pharmacokinetic (PK) to~     insulin of a replicate single dose of Afrezza inhaled Technosphere Insulin (TI) in T1DM~     patients in a euglycemic clamp setting.~      To characterize the within-subject variability in the metabolic activity (pharmacodynamic~     [PD]) of a replicate single dose of Afrezza inhaled TI in T1DM patients in a euglycemic clamp~     setting.~      Secondary Objectives:~      To assess the PK characteristics of a replicate single dose of Afrezza inhaled TI in a~     euglycemic clamp setting.~      To assess the PD characteristics of a replicate single dose of Afrezza inhaled TI in a~     euglycemic clamp setting.~      To assess the safety and tolerability of a replicate single dose of Afrezza inhaled TI in a~     euglycemic clamp setting.~   "
82635|NCT02485314|"~     The Participation and Environment Measure for Children and Youth (PEM-CY) is the first~     instrument that combines parental assessment of children's participation in home, school, and~     community activities with qualities of each environment that are perceived to support or~     hinder participation. This combined format may help to clarify the relative impact of~     environmental factors (including the natural and built environment), compared to personal~     factors, on children's participation in specific settings. The aim of this study was to~     examine reliability and validity of Turkish version of the Participation and Environment~     Measure for Children and Youth (PEM-CY).~   "
82636|NCT02485301|"~     The purpose of this study is to assess the safety and immunogenicity of the investigational~     ChAd3-EBO-Z vaccine administered to approximately 3 000 adults in Africa as a single IM dose~     Considering the risk of exposure to Ebola and the potential (based on animal data) for the~     investigational ChAd3-EBO-Z vaccine to afford at least partial protection, all subjects in~     the study will receive the investigational ChAd3-EBO-Z vaccine. The subjects in the Group~     EBO-Z will receive the vaccine at Day 0 of the study, whereas the subjects in the Group~     Placebo/ EBO-Z will receive a placebo at Day 0 (as a control) and will receive the~     investigational ChAd3-EBO-Z vaccine at Month 6, provided that no safety concerns are raised.~     In addition, vaccinating all subjects in the study with the investigational ChAd3 EBO Z~     vaccine will allow an increase of the safety database of the investigational vaccine. In case~     the geographic range of Ebola virus Zaire (EBOV) transmission expands to encompass any of the~     regions where this trial is conducted, earlier administration of the investigational~     ChAd3-EBO-Z vaccine to the subjects in the Group Placebo/ EBO-Z will be considered in that~     region.~   "
82637|NCT02485288|"~     The purpose of the PaTH Network AF Clinician-Patient Partnership Cohort is to use clinical~     data from electronic health records (EHR) and patient reported outcomes (PRO) to answer~     questions of clinical importance to patients, providers, and other stakeholders.~   "
82638|NCT02485275|"~     Our study aims to explore the value of new imaging technique package in predicting early~     neurological deterioration (END) as well as 90-day unfavorable outcome in patients with acute~     ischaemic stroke.~   "
82703|NCT02484430|"~     This phase II trial studies how well sapanisertib works in treating patients with acute~     lymphoblastic leukemia that has returned after a period of improvement (relapsed) or has not~     responded to previous treatment (refractory). Sapanisertib may stop the growth of cancer~     cells by blocking some of the enzymes needed for cell growth.~   "
82639|NCT02485262|"~     Chronic Hepatitis C virus (HCV) infection is the leading cause of advanced liver disease~     worldwide. The virus successfully evades host immune detection and has highly restricted~     requirements for growth in vitro that for many years hampered efforts to find a safe,~     uncomplicated, and reliable oral antiviral therapy. Ten years after discovery, pegylated~     interferon-alpha and ribavirin (PR) treatment for 24-48 weeks became the standard of care~     (1-5). PR therapy offered limited performance and availability across the diverse spectrum of~     HCV disease and was fraught with excessive and often limiting side effects. The first direct~     acting agents (DAAs) were protease inhibitors (PIs) that were introduced in 2011 and could~     only be used only in combination with PR because of concerns for rapid PI viral resistance.~     Although the first generation PIs added increased efficacy to the PR regimen, they also added~     new side effects and untoward drug interactions (6-8). Sofosbuvir (SOF) is a potent~     nucleoside inhibitor (NI) that has recently been approved for treatment of HCV. The drug has~     low toxicity, high resistance barrier, and minimal drug interactions with other HCV DAAs such~     as PIs and anti-NS5A agents. SOF is safe and effective across different viral genotypes,~     disease stages, and special patient groups such as those co-infected with HIV. When used in~     combination with ribavirin or another DAA, SOF has revolutionized the HCV treatment spectrum~     and set the stage for nearly universal HCV antiviral therapy. Sustained virologic response~     (SVR12) for SOF plus ribavirin and pegylated interferon (PR) is 90% for genotype 1 and 85-94%~     for genotypes 2 and 3 (9-16). SOF plus simeprevir (protease inhibitor) showed a 94% SVR12 for~     genotype 1 (9-16). More so than any other anti-HCV drug developed to date, SOF offers the~     widest applicability for all infected patients yet can be given in a personalized regimen to~     maximize performance~   "
82640|NCT02485249|"~     To evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate~     ophthalmic solution, EGP-437, using the EyeGate® II Drug Delivery System (EGDS) in patients~     with macular edema (ME)~   "
82641|NCT02485236|"~     The study aims to compare the efficacy of Nasal High Flow Therapy (NHF) with low-flow oxygen~     supplementation in improving postoperative intermittent desaturations. If so, this mode of~     therapy would provide a cost effective, relatively easy to implement, and better tolerated~     treatment to Continuous Positive Airway Pressure (CPAP) for oxygen stabilization.~   "
82642|NCT02485223|"~     This is a pilot study (a small scale study testing procedures so that the investigators can~     apply this to a larger scale study). This study will test the accuracy of a new brain scan~     (Magnetic Resonance Imaging) technique in predicting the diagnosis of multiple sclerosis (MS)~     in patients where there is uncertainty about the diagnosis. For patients where there is a~     suspicion (but not definite) diagnosis of MS, an additional MRI brain scan will be offered.~     There will be no other research tests and the patient is followed up to see what the eventual~     diagnosis is. The investigators will then review the original brain scan to see if this~     predicted the diagnosis of MS or not.~   "
82643|NCT02485210|"~     The elimination of pathogenic microorganisms from the root canal system is one of the main~     points in order to have success in endodontic treatment. The objective of this study is to~     perform a randomized controlled clinical trial to compare the effectiveness of success in~     endodontic treatment of primary teeth when combined with photodynamic therapy. Will be~     selected 30 primary teeth of children aged between 3 and 6 years. The teeth will be divided~     into two groups: group I control, which will be applied the conventional endodontic treatment~     and group II to be held endodontic treatment with application of photodynamic therapy. In~     both groups will be made microbiological evaluations before and after endodontic treatment~     and clinical and radiographic evaluations will be conducted in the day, 1 month, 3 months and~     6 months after treatment comparing the treatment performed in both groups.~   "
82644|NCT02485197|"~     This is a small pilot aerobic training trial designed to examine differences between~     normal-high and low vitamin D levels and 7-days of aerobic training on local VO2 measured by~     non-invasive Hybrid Diffuse Optical Spectroscopy.~   "
82645|NCT02485184|"~     portal vein thrombosis may be a negative prognostic marker of variceal bleeding in liver~     cirrhosis. Compared with conventional endoscopic and pharmacological therapy, transjugular~     intrahepatic portosystemic shunt may further improve the outcomes of portal vein thrombosis~     in liver cirrhosis with variceal bleeding.~   "
82646|NCT02485171|"~     The main objective of this study is to evaluate the feasibility and acceptability of the use~     of the robot SAFEWALKER complement classical rehabilitation in a group of elderly patients~     over 70 years during the rehabilitation of post-fall syndrome.~   "
82647|NCT02485158|"~     The purpose of this study is to examine whether individual differences in acute responses to~     drugs co-vary across three drugs from different drug classes: alcohol, amphetamine and~     delta-9-tetrahydrocannabinol (THC). The investigators hypothesize that individuals who~     experience greater rewarding effects from one drug will also experience more rewarding~     effects from the other drugs.~   "
82648|NCT02485145|"~     Osteoarthritis (OA) affects over 30 million people in the United States and represents our~     nation's leading cause of disability. Data for the years between 1996-2005, indicate that OA~     raised overall health care costs by $185.5 billion annually. Largely as a consequence of this~     disease, the number of patients undergoing joint replacement surgery will quadruple over the~     next 17 years. Importantly, several recent studies have demonstrated that OA is an~     independent risk factor for cardiovascular disease . Presently investigators have no~     medications that alter the natural history of OA. Weight control, exercise and some physical~     therapy measures are the only interventions short of total joint replacement that alter the~     course of this disease. To make matters worse, investigators have experienced only setbacks~     in use of medications aimed at symptom control. Recognition of toxicities of non-steroidal~     anti-inflammatory drugs (NSAIDs) and narcotic-based analgesics has narrowed the presently~     available armamentarium for pain control in OA . Clearly OA is a major factor that demands~     better solutions as the health care system is redesigned.~      OA involving the hands represents a major part of the overall burden of this disease. In~     radiographic surveys about a quarter of the total US population has changes consistent with~     OA involving the hands. Among the elderly, radiographic hand OA has been found in over half~     of such individuals and as many as a quarter of them suffer from pain and functional~     incapacitation. The joints affected typically are the first carpometacarpal (CMC-1) joint,~     the distal interphalangeal (DIP) joints, and the proximal interphalangeal (PIP) joints .~     Therapeutic options include acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), and~     a variety of physical measures such as physical therapy, bracing, and heat and cold~     applications. To achieve some symptomatic benefit while limiting systemic toxicity, topical~     therapies have been developed which either act as counter irritants, seek to reduce substance~     P (capsaicin), or to deliver an NSAID locally through the skin. The leading example of the~     latter is Diclofenac sodium gel which was shown to reduce pain intensity and improve hand~     function in a double blind controlled trial. However none of these measures have proven~     sufficiently effective to meet patient needs. Topical polytherapy will be employed in this~     study to see if it will be effective against the pain of OA.~   "
82742|NCT02483910|"~     The purpose of this study is to test whether Direct Instruction - Language for Learning~     (DI-LL) is an effective way to teach language skills to children with autism spectrum~     disorder (ASD) and moderate language delay. Direct Instruction - Language for Learning~     (DI-LL) uses face to face instruction and specific lessons to teach children language skills.~     This method has been used previously in children with language delays, but it has not been~     carefully studied in children with autism spectrum disorder. This study will compare DI-LL~     and ongoing treatment as usual to treatment as usual (speech therapy, language services,~     etc.) alone.~   "
82649|NCT02485132|"~     Sulfonylurea are known to be associated with a risk of hypoglycaemia. However, little is~     known about the real frequency of asymptomatic or unreported hypoglycemia and their impact on~     glycemic control and quality of life among patients using sulfonylureas (SUs). The frequency~     of hypoglycemia is probably underestimated since self-monitoring of blood glucose (SMBG) fail~     to identify asymptomatic episodes, especially among patients with higher risk of hypoglycemia~     unawareness (longer diabetes duration, elderly, recurrent hypoglycemia, etc.). No previous~     studies have reported total hypoglycemia as measured by continuous glucose monitoring system~     (CGMS) in a large group of Canadians, therefore underestimating the true incidence of these~     events. As with age hypoglycemia perception is reduced and consequences can be increased due~     to frailty, elderly could be especially sensitive to the risk of hypoglycemia. Documentation~     of the total number of hypoglycemia is a relevant objective to really appreciate the~     potential impact of SUs in the Canadian context.~      The investigators propose a multicenter observational prospective study in order to study the~     incidence of hypoglycaemia measured by CGMS among patients with type 2 diabetes mellitus~     (T2DM) newly prescribed a SU. The investigators propose to perform a baseline testing~     (pre-initiation of the SU), at initiation (first week after the first dose of the SU) and~     after a 3 months follow-up of treatment, including medical history measures, quality of life~     and diabetes treatment satisfaction.~      In patients with T2DM not at goal (A1c >7.0 mmol/L), and newly prescribed a SU, the~     objectives and hypotheses of the study are to estimate the incidence rate of hypoglycaemia as~     measured by continuous glucose monitoring system (CGMS) over a total of 3 weeks period~     following the initiation of the SU.~   "
82650|NCT02485119|"~     The primary objectives of the Phase I study 15404 are to evaluate the safety, tolerability~     and pharmacokinetics of BAY94-9343 given once every 3 weeks in Japanese subjects with~     advanced, refractory solid tumors.~      The secondary objectives are to investigate the efficacy, biomarkers and immunogenicity.~   "
82651|NCT02485106|"~     This study aimed to investigate the effect of decontamination by rifaximin in severe~     alcoholic hepatitis patients. Patients who take corticosteroid or pentoxifylline will be~     randomly allocated to rifaximin group or control group.~   "
82652|NCT02485093|"~     Optimal pacing strategy for patients with SND is still unknown, although several publications~     in the past years demonstrated a deleterious effect of ventricular pacing. However, pacing~     has always been apical in these trials, and to which extent this absence of pacing is~     beneficial for patients with very long PR intervals is still to be found.~      The aim of this study is to compare ventricular septal pacing to no pacing in patients with~     SND.~   "
82653|NCT02485080|"~     The goal of this pilot study is to examine both efficacy and tolerability in patients with~     HCV genotype 1 and mild decompensation with Child-Pugh-Turcott score of 6 or lower. The CPT~     score is used to assess the prognosis of chronic liver diseases, as well as the required~     strength and treatment and necessity of liver transplantation. A higher CPT score denotes~     higher necessity of liver transplantation.~   "
82654|NCT02485067|"~     The primary purpose of this study is to assess the efficacy and safety of~     THVD-201(Combination of tolterodine and pilocarpine) in patients with Overactive bladder~     during the period of treatment, 12 weeks.~      This study also includes an open label extension period of an additional 12 weeks following~     the treatment to assess long-term efficacy and safety of THVD-201 in patients with Overactive~     bladder.~   "
82655|NCT02485054|"~     The transient visual disturbances (TVD) are defined by a short abnormality of visual~     function. Their etiology may be ophthalmological, neurological non-ischemic or of ischemic~     origin.~      The difficulty is to recognize an ischemic mechanism which imposes emergency cares.~      A clinical score could help the clinician to recognize the etiology of the TVD .~   "
82656|NCT02485041|"~     Healthy male volunteers were administered alone and in combination with dapoxetine 30mg~     mirodenafil 100mg for three times, respectively and the pharmacokinetic interaction was~     compared between the two drugs.~   "
82657|NCT02485028|"~     Healthy male volunteers were administered alone and in combination with dapoxetine 30mg~     mirodenafil 50mg for three times, respectively and the pharmacokinetic interaction was~     compared between the two drugs.~   "
82658|NCT02485015|"~     The purpose of this study is to evaluate the safety and efficacy of Apatinib combined with~     cytokine-induced killer cell (CIK) vs Apatinib as the third line therapy for patients with~     advanced gastric cancer.~   "
82659|NCT02485002|"~     This study will include patients aged between 18 and 65 who will undergo retrograde~     infrarenal surgery (RIRS) due to renal stone(s). A total of 60 patients (male or female) will~     be recruited, and will be randomized into 2 groups consisting of 30 patients in each group.~     The first group of patients will undergo RIRS with a ureteral access sheath (UAS) positioned~     prior to surgery; and the second group will undergo RIRS without UAS. As use of UAS decreases~     the pressure in the renal pelvis during RIRS, it is aimed to evaluate whether using UAS or~     not affects the kidney functions. besides the routine kidney function tests, namely urea and~     creatinine, neutrophil gelatinase-associated lipocalin (NGAL) (a more specific and early~     marker of kidney function) will be used to assess the differences in the kidney functions.~     Preoperative blood urea and creatinine levels and urine NGAL levels will be studied for all~     patients. After the surgery, blood urea and creatinine levels will be again studied as well~     as urine NGAL levels at postoperative 2nd hour, 72nd hour and 1st week.~   "
82660|NCT02484989|"~     Currently, there is little recent data on regional variations in treatment methods, neonatal~     units that provide retinopathy (ROP) treatment, facilities for treatment available at each~     unit including anaesthetic support for such preterm babies, facilities to transfer babies to~     units that offer treatment etc. While some parts of the UK have established neonatal networks~     and agreements among units for ROP treatment, in other parts, such arrangements are~     illdefined.~      The number of babies needing ROP treatment may be higher since the introduction of revised~     guidelines in 2008 as earlier treatment has been shown to be beneficial. Collecting~     epidemiological data through the British Ophthalmic Surveillance Unit (BOSU) on the incidence~     of treatable ROP, the treatment methods used and facilities for treatment will provide the~     foundation for effective planning of resources and manpower to deal with the additional~     demand.~   "
82661|NCT02484976|"~     BASIC fMRI is a prospective single center intervention trial using fMRI imaging in 9-11 year~     old obese male and females pre and post family-based behavioral treatment of 24 weeks~     duration to determine the relationship between impulsivity and central satiety responses.~   "
82754|NCT02483754|"~     The study was designed to employ MOCA to screen mild cognitive impairment (MCI) in military~     retirees and to analyze the associated risk factors. As such, MOCA was revised to be~     validated for the Chinese context.~   "
82755|NCT02483741|"~     Since there is an evidence that Manuka honey is an antibacterial agent, the present study~     aims to confirm this characteristic and assess its effect in improving healing and reducing~     postsurgical symptoms, if topically applied after the surgical removal of impacted mandibular~     third molars~   "
82662|NCT02484963|"~     All Cirrhosis liver patients (Child A/B/C) presenting to Institute of Liver and Biliary~     Sciences will be screened for sleep disturbance and excessive daytime sleepiness with Epworth~     sleep score/ Pittsburgh sleep quality index. 52 patients of clinical/ radiological/ biopsy~     proven cirrhosis (Child A/B) will be enrolled after ruling out possibility of psychiatric~     illnesses like depression and anxiety with the help of PHQ-9 / GAD-7 questionnares. Patients~     who are suffering with sleep disturbance as evaluated with Pittsburgh sleep quality index~     will undergo polysomnography and will be randomised to two groups after fulfilling all~     inclusion criterias. Patients in group (Group 1) will receive zolpidem 5mg at bed time daily~     and patients in control group will receive placebo at bed time daily. The treatment will be~     continued for 4 weeks. After 4 weeks enrolled patients will be reassessed with PSQI and~     polysomnography. All patients will be advised regarding sleep hygiene.~   "
82663|NCT02484950|"~     The primary objective of this study is to compare the clinical outcomes of arthroscopic~     rotator cuff repair with and without augmentation of mesenchymal stem cells (MSCs).~     Mesenchymal stem cells promote tissue regeneration by differentiating into adult cell lines~     and by supplying growth factors to their implanted environment. They have been shown to be~     effective in improving both overall healing and tendon integrity in rotator cuff repair. This~     study will follow 100 patients in the United States and track their clinical outcomes for at~     least one year post-operatively.~   "
82664|NCT02484937|"~     This study will demonstrate that functional improvement measures over a 6-month period for~     chronic low back patients under the care of Primary Care Provider (PCP), using a therapeutic~     plan formulated initially by the Pain Medicine Specialist (PMS), are equivalent to those~     under the care of the PMS only. Chronic low back pain patient will be initially be evaluated~     by the PMS. If no interventional pain therapy is required, a multimodal therapeutic plan~     (pharmacological and/or non-pharmacological) will be formulated to manage the chronic low~     back pain. Patients will be randomized into one of the two groups: Group 1 - Subjects will be~     treated monthly for the following 6 months by PMS, and Group 2 - Subjects will be treated by~     their own PCP for monthly visits for 6 months.~   "
82665|NCT02484924|"~     A retrospective real world analysis of bleeding events with ticagrelor compared to~     clopidogrel in ACS patients.~   "
82666|NCT02484911|"~     The purpose of the study is to mainly evaluate the efficacy and safety of aprepitant in~     combination with olanzapine ,palonosetron and dexamethasone for the prevention of~     chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly or moderately~     emetogenic chemotherapy.~   "
82667|NCT02484898|"~     The purpose of the Medtronic SEEQ™ Performance study is to build further evidence on the~     clinical and economic benefit of the Medtronic market-released SEEQ™ Mobile Cardiac Telemetry~     System/External Cardiac Monitor System (MCT/ECM).~   "
82668|NCT02484885|"~     Healthy volunteers aged 18-85 will undergo hyperpolarized 129-Xe MRI and pulmonary function~     testing for the development of tools to assess image signal to noise and reproducibility of~     spin-density and diffusion-weighted imaging.~   "
82669|NCT02484872|"~     Systemic inflammation is a potential prognostic factor in cancer. Inflammation scores as the~     Glasgow score have been tested in cancer and specifically in lung cancer patients. The aim of~     the study is to look at the prognostic and predictive value of inflammation during cancer~     evolution, on the risk of complications leading to ICU admission and the risk of death.~   "
82670|NCT02484859|"~     Functional endoscopic sinus surgery (FESS) is indicated in diseases such as chronic sinusitis~     refractory to medical treatment, nasal polyposis, mass lesions in the nasal cavity. The~     purpose of this study is to determine whether tramadol and metoprolol are as effective as~     remifentanil in providing controlled hypotension during FESS.~   "
82671|NCT02484846|"~     Fifty healthy, young participants (10 male, 40 female) completed two 3-hour study sessions~     that were at least five days apart. The first session was a baseline. The sleep intervention~     took place on the night prior to Session 2, where the amount of time in bed was manipulated~     to be 60-130% of the individual's habitual sleep time. Within both sessions, subjective~     (Stanford Sleepiness Scale, SSS) and objective (Psychomotor Vigilance Test, PVT) alertness~     were measured. During the middle of each session, a 40-minute ad libitum meal opportunity~     allowed participants to eat from eight different food items. Food healthfulness, caloric~     density, distribution and number of calories were measured and compared to alertness levels.~   "
82672|NCT02484833|"~     -  To investigate whether cetuximab alone (given until progression or cumulative toxicity)~          after 8 cycles of FOLFIRI + cetuximab results in a non inferior Progression Free~          Survival when compared with continuous FOLFIRI + cetuximab (given until progression or~          cumulative toxicity).~        -  To assess whether an improvement in the incidence of grade 3-4 hematological and~          non-hematological adverse events (AEs) can be achieved in the experimental arm~          (cetuximab alone after 8 cycles FOLFIRI + cetuximab) as compared to the continuous~          chemotherapy arm (FOLFIRI plus cetuximab)~        -  To explore the possibility of using liquid biopsies for molecular profiling as well as~          monitoring treatment activity in mCRC pts receiving cetuximab based therapy~   "
82673|NCT02484820|"~     In France, threatened preterm labour concerns 6.5% of pregnancies and is associated with a~     premature birth in 25.4% of cases.~      After 48 hours effective tocolysis, patients do not receive any further treatment while their~     risk of premature birth has risen from 6.5% to 25%.~      A pessary is a silicone ring encircling the cervix. It was initially used as medical~     treatment of genital prolapse but studies were also conducted for pregnant women in 2~     high-risk premature birth situations: cervical incompetence and twin pregnancies.~      The multicenter PECEP trial conducted by Goya and al. in asymptomatic short cervix patients~     between 18 and 22 weeks of gestation showed a significant reduction of premature birth before~     34 and 37 weeks of gestation. Thereby, the investigator assume that use of pessaries in~     patients presenting a resolutive threatened preterm labor will also be effective.~      To evaluate this hypothesis, the investigator designed a randomized prospective single-center~     open clinical trial comparing pessary associated with standard care (1st group) versus~     standard care only (2nd group) in patients experiencing an episode of resolutive threatened~     preterm labor.~   "
82756|NCT02483728|"~     The purpose of this study is to evaluate if metal patch testing in metal allergic patients is~     useful for predicting the development of allergic skin disease or systemic symptoms in~     patients who recieve a metal orthopedic implant.~   "
82675|NCT02484794|"~     Cognitive behavioural therapy (CBT) is the most empirically supported and researched~     treatment for eating disorders. A central component of CBT for eating disorders is~     self-monitoring which involves patients keeping a paper food record of their meals and~     associated thoughts, feelings, and behaviours and receiving feedback from a clinician to help~     target dysfunctional cognitions and behaviours. Given the issues associated with paper~     journals such as non-compliance, feelings of shame when used in public, and delayed feedback,~     researchers have developed an evidence-based smartphone application (Recovery Record) for~     eating disorder self-monitoring that links patients with their clinicians and offers~     additional features designed to enhance treatment.~      The current pilot randomised controlled trial (RCT) seeks to evaluate this smartphone~     application in a clinical setting alongside standard eating disorder outpatient treatment.~     Patients will be recruited from the Nova Scotia Health Authority Eating Disorder Outpatient~     Program and randomised to receive either standard treatment or standard treatment with the~     app (instead of the paper food record). The efficacy and acceptability of both treatments~     will be assessed and compared. Coping skill use and self-efficacy among patients will also be~     examined given the skill building focus of treatment and in-app capabilities to deliver~     real-time coping skill suggestions to patients.~      This pilot study will be the first to examine the efficacy and acceptability of a smartphone~     application in eating disorder clinical treatment and if successful, should provide~     preliminary support for the use of smartphone applications over traditional paper food~     journals as a self-monitoring tool for augmenting specialty eating disorder clinical~     treatment.~   "
82676|NCT02484781|"~     Total hip replacement surgery is a very successful operation with good long-term results. Hip~     resurfacing arthroplasty is offered as a treatment option for young and active patients with~     osteoarthritis of the hip. It has been proposed as a treatment option for younger patients~     because of claims that it preserves femoral bone stock and has better functional outcomes.~     The assessment of gait after hip replacement surgery may be able to determine functional~     differences between patients who have undergone total hip replacement / arthroplasty (THA)~     versus hip resurfacing.~   "
82677|NCT02484768|"~     The purpose of this study is to to establish proof-of-concept for efficacy of iron~     isomaltoside 1000 in subjects with Restless Legs Syndrome.~      The study is a randomised, comparative, double-blind study with a 3 months extension.~     Subjects with restless leg syndrome (RLS) will be randomised 2:1 to one of the following~     treat-ment groups:~        -  Group A (42 subjects): 1000 mg iron isomaltoside 1000~        -  Group B (21 subjects): Placebo infusion~      Furthermore, non-responders, who continue to meet entry requirements, will receive 1000 mg~     iron isomaltoside 1000 at week 6.~   "
82678|NCT02484755|"~     The USP8 gene and its downstream target, epidermal growth factor receptor (EGFR), is a~     potential therapeutic target of Cushing disease. The EGFR inhibitor, Gefitinib, has been~     shown to reduce the production of ACTH both in vitro and in vivo, especially in USP8-mutated~     corticotrophin adenomas. The investigators hypothesize that Gefitinib will suppress pituitary~     corticotroph tumor ACTH production and normalize urinary free cortisol levels in patients~     with USP8-mutated Cushing's disease. Gefitinib is an FDA approved drug used to treat~     non-small cell lung cancer. However, in this study, the drug will be used to treat~     corticotrophin adenoma.~   "
82679|NCT02484742|"~     The main purpose of this study is to learn about the effects of repeated exposure to sleep~     disruption (3 cycles of sleep disruption, each consisting of three days in a row where sleep~     is shortened and disrupted, followed by a single night of recovery sleep) on inflammation,~     mood, and pain processing (experiences/perceptions of pain). Purpose of this research project~     is to understand the mechanisms of how sleep disruption may change mood and the experience of~     pain. Understanding those mechanisms is important to develop interventions that may help to~     reduce the effects of sleep disruption on mood and pain.~   "
82680|NCT02484729|"~     This study will be a randomized, single-blind, placebo-controlled first-in-human study in~     healthy male subjects to assess the safety, tolerability and pharmacokinetics of single~     ascending doses of AZD9977. In Part B of this study the regional absorption of AZD9977 along~     the gastro-intestinal tract will be investigated using the IntelliCap® system in a~     non-randomized, open-label, fixed-sequence design. The study will be performed at a single~     study centre.~   "
82681|NCT02484716|"~     Timolol is a nonselective β-blocker commonly used in the treatment of glaucoma. Recently it~     has been used topically for the treatment of superficial hemangiomas. Because of its~     potential mechanism of action, it is possible that timolol could also be useful for the~     treatment of epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT). Moreover a case was~     reported in 2012 showing an improvement of nosebleeds with the use of topical nasal timolol.~     The aim of the study is to evaluate timolol nasal spray efficacy in HHT.~      The main objective of this trial is to evaluate, 3 months after the end of the treatment, the~     efficacy on the duration of nosebleeds of a 4 weeks timolol intranasal treatment in HHT~     patients with nosebleeds (>20 min/month). Secondary objectives are to evaluate the tolerance,~     the efficacy at 6 months after the end of the treatment, and the efficacy on anemia and on~     clinical parameters (nosebleeds, quality of life and blood transfusions).~      This is a prospective double blind phase II study, randomized versus placebo using an~     allocation ratio of 1:1. A total of 58 patients will be included. The product (solution with~     timolol at 0.5% or placebo) is self-administered by the patient with a posology of one spray~     (50 µL) in each nostril twice a day for 28 consecutive days.~   "
82682|NCT02484703|"~     This study will evaluate the safety, tolerability, efficacy, and pharmacokinetic and~     pharmacodynamic activity of 3 different dosages of RO5186582 compared with placebo. A total~     of approximately 46 participants will be enrolled, in order to have at least 32 evaluable,~     and will be randomly assigned to 1 of 4 treatments in a 1:1:1:1 ratio, with 9 children per~     treatment arm. The target ratio between 6-8 years and 9-11 years age groups is approximately~     1:1 in each treatment arm, with a minimum of 3 children per age group in each treatment arm.~   "
82683|NCT02484690|"~     This multiple-center, multiple-dose and regimen, randomized, double-masked active~     comparator-controlled, double-masked, five parallel group, 36-week study will evaluate the~     efficacy, safety, tolerability, and pharmacokinetics of RO6867461 in participants with CNV~     secondary to AMD.~   "
84386|NCT02462473|"~     The purpose of this study is to determine the number of Medication Treatment Modifications~     (MTMs) made by the clinician at every visit when antipsychotic medication plasma levels~     (AMPL) results are available compared to when AMPL results are not available.~   "
82684|NCT02484677|"~     Docetaxel, Cisplatin, 5-Fluorouracile (=TPF) is a mainstay for treating head and neck~     cancers, but elderly or fragile patients are often precluded because of the risk of severe~     toxicities associated with this protocol. DPD (Dihydro Pyrimidine Dehydrogenase) deficiency~     is a pharmacogenetic syndrome responsible for most of the severe/lethal toxicities showing in~     5-FU (5-Fluorouracile)-treated patients, and our institute has developed a strategy for the~     routine determination of Dihydro Pyrimidine Dehydrogenase (DPD) status prior to starting~     giving the 5-FU so as to roughly adapt drug dosage according to the Dihydro Pyrimidine~     Dehydrogenase (DPD) status. This project aims at developing a Bayesian strategy to further~     individualize 5-FU dosing to reach a target exposure of area under curve (AUC). To this end,~     100 patients with head and neck cancer and scheduled for a Docetaxel, Cisplatin,~     5-Fluorouracile (=TPF) regimen will be included.~   "
82685|NCT02484664|"~     The investigators will perform a two-center phase I trial of celecoxib (COX-2 inhibitor)~     administered at 200mg by mouth daily for 6 months. Up to 12 adult women with LAM will be~     recruited (between 4-8 at each site). The Specific Aims are:~      Aim 1: To investigate whether, in LAM patients, celecoxib is safe and well tolerated, and has~     evidence of clinical benefit.~      Aim 2: To investigate the potential value of a novel biomarker of LAM, quantitative~     measurement of the number of TSC2 mutant LAM cells per ml of blood, to assess disease~     severity.~   "
82686|NCT02484651|"~     The investigators hypothesize that an anesthetic protocol maintaining deep neuromuscular~     block throughout the entire surgical procedure followed by sugammadex reversal, would~     suppress EMG activity and result in improved anesthetic stability by reducing the variability~     of the Bispectral Index of the EEG, and be beneficial by reducing the total doses of the~     anesthetic drugs propofol and remifentanil required to maintain an adequate level of~     anesthesia (BIS between 40 and 60).~   "
82687|NCT02484638|"~     The purpose of this study is to investigate the pharmacokinetics (PK), efficacy, and safety~     of rVIIa-FP (CSL689). The study will enroll approximately 54 male subjects, 12 to 65 years of~     age, with hemophilia types A or B who have developed inhibitors to FVIII or FIX. The study~     consists of 3 sequential parts (Parts 1, 2, 3): The purpose of Part 1 (PK part) is to~     evaluate the PK of a single treatment of CSL689 (low dose or high dose) and compare with the~     PK of a single treatment of Eptacog alfa (low dose or high dose). In Part 1, CSL689 and~     Eptacog alfa will be given by the doctor at the study center. The purpose of Part 2~     (Dose-evaluation part) is to identify which of the 2 tested dose levels of CSL689 shows the~     best efficacy and safety in stopping acute bleeding events (this dose will be called the~     population best dose). The purpose of the final Part 3 (Repeated-dose part) is to confirm~     the efficacy and safety of the population best dose identified in Part 2. In Parts 2 and 3,~     subjects will self-administer a specified number of CSL689 infusions at home on-demand (ie,~     when a bleeding event occurs), will keep an electronic diary, and will visit the center at~     monthly intervals. This study is expected to last for up to 16 months for the subjects~     participating in all 3 parts, and up to 9 months for the subjects participating in Part 3~     only.~   "
82688|NCT02484625|"~     Dairy products have a potential to be healthy snack foods for children and are provided in a~     variety of food matrices. For instance, milk represents a fluid product, yogurt can be~     classified as a semi-solid food, and finally cheese is the example of the solid food. This~     experiment is aimed to examine the effect of dairy products with different food matrices on~     satiety and food intake in children. Dairy products will be compared with other non-dairy~     snacks popular among children including cookies and potato chips.~   "
82689|NCT02484612|"~     Acute exercise has been shown to affect subsequent energy intake in obese adolescents.~     Indeed, it has been shown several times that an intensive bout of exercise (above 70% of the~     individual maximal capacities) can reduce energy intake at the following meal in obese~     adolescents, with no modification of his appetite feelings.~      Although this results has been replicated several times, it remains unknown if those~     nutritional adaptations are due to post-exercise modifications of some gastro-peptides~     implicated in appetite control, as detailed in adults.~      The aim of this work is to question whether or not post-exercise energy intake is explained~     by appetite-regulating hormones that are affected by the exercise bout in both lean and obese~     youth.~   "
82690|NCT02484599|"~     The purpose of this study is to test the therapeutic effects of a computerized attention~     training for patients with Anorexia Nervosa (AN). The primary aim is to determine if a~     computerized attention training can modify attention towards food and ameliorate eating~     disorder symptoms and related difficulties, such as anxiety. The secondary aim is to explore~     underlying mechanisms that contribute to these improvements. The stability of potentially~     observed effects over a one-month period will also be determined.~   "
82691|NCT02484586|"~     The aim of this study is to assess the visual performance of multiple optimised prototype~     soft contact lens designs compared to commercially available contact lenses.~   "
82692|NCT02484573|"~     This study seeks to investigate whether non-selective beta blocker treatment decreases~     intestinal permeability in cirrhotic patients by altering the expression of genes encoding~     intercellular junction proteins.~   "
82693|NCT02484560|"~     Duchenne Muscular Dystrophy (DMD) is a X-linked genetic disorder primarily affecting males,~     resulting in an absence of dystrophin which ultimately leads to progressive muscle~     degeneration. Patients with DMD progressively lose functional abilities of movement, breath,~     and eventually the ability to circulate blood. Currently, there is no cure for DMD, although~     several strategies are being tested for treatment, none have yet proven to be sufficient.~     Children with DMD are generally divided into two groups based on severity or progression of~     the disease, non-ambulatory and ambulatory. Ambulatory patients are capable of walking~     independently while non-ambulatory patients cannot walk independently.~   "
82694|NCT02484547|"~     The primary objective of the study is to evaluate the efficacy of monthly doses of aducanumab~     in slowing cognitive and functional impairment as measured by changes in the Clinical~     Dementia Rating-Sum of Boxes (CDR-SB) score as compared with placebo in participants with~     early AD. Secondary objectives are to assess the effect of monthly doses of aducanumab as~     compared with placebo on clinical progression as measured by Mini-Mental State Examination~     (MMSE), AD Assessment Scale-Cognitive Subscale (13 items) [ADAS-Cog 13], and AD Cooperative~     Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version)~     [ADCS-ADL-MCI].~   "
82695|NCT02484534|"~     Cirrhotic patients are patients with high morbidity and mortality, it is very important for~     determining the prognosis of these patients. The importance increases when these patients~     waiting for a liver transplant. The Model for End-Stage Liver Disease (MELD) is a reliable~     measure of mortality risk in patients with end-stage liver disease. It is used as a disease~     severity index to help prioritize allocation of organs for transplant. MELD uses the patient~     values for serum bilirubin, serum creatinine, and the international normalized ratio for~     prothrombin time (INR) to predict survival.~      Blood tests that we use today in daily practice to evaluate the coagulation system (PT, PTT)~     do not check actually the functioning of the system, but examine the level of clotting~     factors and therefore only verify that the side of Anticoagulant of the equation and not the~     side of the procoagulant .~      To examine the coagulation system function tests have been developed, One of them is the~     thrombin generation. The purpose of the trial is to determine whether thrombin generation~     test can be a prognostic indicator in patients cirrhosis.~   "
82696|NCT02484521|"~     PPI is an objective measure to assess pre-attentive processes that have already been tested~     before in the case of schizophrenia. The investigators aim to assess through this instrument~     two main characteristics, that the investigators assume are of relevance which are the~     duration of illness and the type of pharmaceutical treatment, patients receive.~      The investigators believe these two main characteristics are critical to the ability of the~     patients in improvement of their PPI response to startle reflex.~   "
82697|NCT02484508|"~     Previous study showed that Guli capsule could suppress the adjuvant multiple arthritis; have~     inhibitory effect on carrageenan gelatinous and formaldehyde foot swelling; improve the~     symptom of osteoporosis patients; and improve pain and limited joint activities of rheumatoid~     patients.~      To further verify the clinical effect of Guli capsule in the treatment of knee~     osteoarthritis, the investigators perform this multi-center clinical study.~   "
82698|NCT02484495|"~     The purpose of the study is to evaluate the impact of a package of interventions including~     production and distribution of locally produced complementary foods (via so-called~     Grain-banks) and Micronutrient Powders (MNPs) supplementation, and optimized food based~     Complementary Feeding Recommendation, on growth and micronutrient status of infants and young~     children. The impact of the intervention package will be evaluated in a quasi-experimental~     matched-control cluster design in infants and young children between 6 - 29 months of age.~     The impact, outcome, and output indicators of infants/children will be assessed in~     cross-sectional samples at baseline, after 9 and 18 months. A total of60 pair clusters are~     selected in which 15 households per cluster will be identified from the eligible population.~     A total of 1800 children from intervention and match-controlled clusters, will be sampled in~     the target age groups. Qualitative and quantitative data will be collected to gather~     information on Knowledge, Attitude and Practice (KAP), Infant and Young Child Feeding~     practices, anthropometry and anemia, following the impact pathway developed for the study.~      Research questions to be answered in this program evaluation are:~        1. What impact does the extended pilot (implementation of local complementary food~          production and MNP) have on:~             1. Growth in children 17-29 months of age~             2. Infant and Young Child Feeding practices in children (6-23m), and~             3. Anemia status in children 11-23 m?~        2. What are determining factors for the impact/no impact related to:~             1. Immediate outcomes: skills and capacity; knowledge, attitude and practices; and~               improved access~             2. Intermediate outcomes: utilization; provision, and ensuring enabling environment~             3. Program performance as measured by program monitoring data on output and~               activities?~   "
82699|NCT02484482|"~     The purpose this study investigate the effect of food on the~     pharmacokinetics/pharmacodynamics and safety of CKD-519~   "
82700|NCT02484469|"~     Team-based learning (TBL) is a learner-centered, instructor-directed strategy for small group~     active learning in large group educational settings. When TBL is conducted correctly, the~     students' performances are equivalent or improved in comparison to either lecture-based~     formats or more traditional small group learning models.1 Nevertheless, few studies have been~     published regarding the insertion of innovative audiovisual tools in the TBL context. The~     Virtual Human Project is described as powerful sequences of three dimension (3D) computer~     graphics video of the human body that aids learning by facilitating an understanding in~     relation to a specific subject. The Virtual Human is composed by video sequences combining~     anatomy, physiology, and morphology in the context of various diseases. There are video~     sequences available for many disciplines, including dermatology and with capacity to produce~     anatomical structures by 3D printer. Despite the incredible potential applications of the~     Virtual Human, few studies have assessed its impact on medical education. The investigators~     did not find any study evaluating TBL with the insertion of iconographic educational material~     that assessed whether this intervention could change the learning progress of students. This~     is the aim of the present study, by comparing students tests scores after a TBL session with~     the VIrtual Human videos about leprosy or a standard TBL session, and to evaluate the~     student's satisfaction with the Virtual Human videos.~   "
82701|NCT02484456|"~     Background:~      - Drugs and talk therapy help treat depression, but these treatments usually take quite a bit~     of time to work. Ketamine is a fast-acting antidepressant, but it has side effects like~     unusual dreams and experiences. The drug AV-101 may have the same antidepressant effects but~     fewer side effects. Researchers want to see if it is effective and safe for people with major~     depressive disorder.~      Objective:~      - To see if the drug, AV-101 is safe and if it treats symptoms of major depressive disorder.~      Eligibility:~      - Adults ages 18-65 with major depression without psychotic features.~      Design:~        -  Participants will be screened under a separate protocol.~        -  Participants will stay in the hospital for 12-14 weeks.~        -  Phase 1 (2-7 weeks): participants will stop taking their medicines then not take any for~          2 weeks. They will have several scans and other procedures.~        -  Phase 2 (6-7 weeks): 2 weeks each of study drug and placebo once a day, with 2 weeks of~          no drugs in between.~        -  Participants will have:~        -  Physical exams~        -  Interviews~        -  Frequent blood collection. A needle will place a small plastic tube in the arm. Some~          blood samples will be taken through this tube.~        -  2 spinal taps (optional). The back will be numbed. A needle will insert a catheter~          between back bones. That will be left in for up to 30 hours. Spinal fluid will be~          collected through it.~        -  5 scans. Participants will lie in a machine with a magnetic field. The machine takes~          pictures of the brain and brain chemicals.~        -  At the end of the study, participants will have medical evaluation, questions, and blood~          tests. Some may continue treatment at the clinic.~   "
82702|NCT02484443|"~     This phase II trial studies how well dinutuximab works when given with sargramostim in~     treating patients with osteosarcoma that has come back after treatment (recurrent).~     Monoclonal antibodies, such as dinutuximab, may find tumor cells and help kill them.~     Sargramostim may help the body increase the amount of white blood cells it produces, which~     help the body fight off infections. Giving dinutuximab with sargramostim may work better and~     kill more cancer cells.~   "
82704|NCT02484417|"~     Background:~      - Respiratory syncytial virus (RSV) can cause respiratory infections. Some of these can be~     life-threatening, especially in young children, the elderly, and people with weak immune~     systems. Researchers want to study RSV infection in a hospital setting in healthy adults.~     They want to use what they learn to test new treatments or vaccines in the future.~      Objectives:~      - To study how the body responds to RSV.~      Eligibility:~      - Healthy volunteers ages 18-50~      Design:~        -  Participants will be screened under another protocol.~        -  Participants will have:~        -  Medical history~        -  Physical exams~        -  EKG. Heart rhythm is measured with small sticky patches on the chest, arms, and legs.~        -  Chest x-ray~        -  Pulmonary function tests. This measures how much air a person can move into and out of~          the lungs.~        -  Blood and urine tests~        -  Nasal washes and/or nasal swabs. For the wash, the nose will be rinsed with a sterile~          liquid. For the swab, the inside of the nostril will be rubbed with a cotton swab.~        -  Participants will have two, possibly three, follow-up outpatient visits, approximately~          1, 2 and 6 months after receiving the dose of RSV.~        -  Participants will stay in the hospital under isolation for 7 or more days after getting~          the virus.~        -  The average stay is 10 days. Participants cannot leave the isolation unit. They cannot~          have visitors.~        -  The virus should cause a mild to medium cold.~        -  Participants will fill out a symptom card every day in the hospital and for 1 month~          after.~        -  Participants will have 2 follow-up visits, 28 and 56 days after leaving the hospital.~        -  Female participants who are sexually active must remain abstinent or use an effective~          form of birth control for 1 month before and after getting the virus.~   "
82705|NCT02484404|"~     Background:~      - MEDI4736 is a drug that may help people s immune systems respond to and kill cancer cells.~     Olaparib is a drug that may inhibit repairing DNA damage of cancer cells. Cediranib is a drug~     that may stop the blood vessel growth of cancer cells. This study has two components. In the~     phase 1 component of the study, researchers want to investigate how well participants~     tolerate the combination of these drugs in treating advanced solid tumors, and in the phase 2~     part of this study, researchers want to study if the combination treatments are effective in~     ovarian cancer.~      Objectives:~        -  Phase 1 part of the study: To determine the safety of the combination of MEDI4736 with~          the drugs olaparib or cediranib.~        -  Phase 2 part of the study: To determine how effective this combination is in treating~          ovarian cancer.~      Eligibility:~        -  Phase 1 part of the study: Adults age 18 or older with advanced or recurrent solid~          tumors that have no standard treatment.~        -  Phase 2 part of the study: Adults age 18 or older with advanced or recurrent ovarian~          cancer that has no standard treatment.~      Design:~        -  Participants will be screened with medical history, physical exam, and blood and urine~          tests. They will have CT or MRI scans. For these, they will lie in a machine that takes~          pictures of their bodies.~        -  Phase 2 part of the study requests the participants to have tumor samples removed.~        -  Participants will get MEDI4636 through an IV. A small plastic tube will be inserted into~          a vein. The drug will be given every 2 weeks for 12 months.~        -  Participants will take olaparib or cediranib by mouth every day.~        -  Every 28 days will be 1 cycle. For cycle 1, participants will have 2 study visits. All~          other cycles, they will have 1 visit. At these visits, they will repeat the screening~          procedures.~        -  Patients will keep a drug and diarrhea diary.~        -  Patients on cediranib will monitor their blood pressure and keep a blood pressure diary.~        -  Participants who can become pregnant, or have a partner who can become pregnant, must~          practice an effective form of birth control.~        -  After 12 cycles, participants will have 1-3 months of follow-up.~   "
82706|NCT02484391|"~     This pilot phase II trial studies how well CPI-613 (6,8-bis[benzylthio]octanoic acid),~     cytarabine, and mitoxantrone hydrochloride work in treating patients with acute myeloid~     leukemia or granulocytic sarcoma (a malignant, green-colored tumor of myeloid cells [a type~     of immature white blood cell]) that has returned (relapsed) or that does not respond to~     treatment (refractory). 6,8-bis(benzylthio)octanoic acid is thought to kill cancer cells by~     turning off their mitochondria. Mitochondria are used by cancer cells to produce energy and~     are the building blocks needed to make more cancer cells. By shutting off these mitochondria,~     6,8-bis(benzylthio)octanoic acid deprives the cancer cells of energy and other supplies that~     they need to survive and grow in the body. Drugs used in chemotherapy, such as cytarabine and~     mitoxantrone hydrochloride, work in different ways to stop the growth of cancer cells, either~     by killing the cells, by stopping them from dividing, or by stopping them from spreading.~     Giving 6,8-bis(benzylthio)octanoic acid together with cytarabine and mitoxantrone~     hydrochloride may kill more cancer cells.~   "
82707|NCT02484378|"~     The purpose of this study is to assess the impact of ten intravenous infusions of 3 mg/kg CER~     001 vs. placebo, given at weekly intervals for ten weeks, on atherosclerotic plaque volume as~     measured by coronary IVUS, when administered to subjects presenting with Acute Coronary~     Syndrome (ACS) with significant plaque volume.~   "
82708|NCT02484365|"~     The preoperative evaluation including sampling blood in pediatric patients is hard to~     perform. However, the knowledge of the baseline cell blood count is important to prepare~     unexpected surgical bleeding etc.. The invasive procedure for blood sampling in small~     children is often failed and sometimes induces iatrogenic blood loss and parent's complaints.~     The Pulse Co-oximetry (Masimo) is recently developed device which can provide noninvasive~     hemoglobin value. However, the accuracy is controversial. There are studies in pediatric~     patients during surgery and in ICU. However, the comparison for preoperative evaluation is~     not analysed. Therefore, the investigators want to evaluate the accuracy for preoperative~     preparation in pediatric patients.~   "
82709|NCT02484352|"~     Intravenous form of oxycodone is recently used for the adjunct of anesthetic agents to avoid~     adverse effects of the stimulation of endotracheal intubation. The potency ratio of oxycodone~     to fentanyl is not absolutely defined. The aim of this study was to assess the optimal dose~     of intravenous oxycodone for attenuation of hemodynamic responses to laryngoscopy and~     endotracheal intubation.~      A prospective, randomized, double-blind study was conducted. Ninety one patients were~     randomly divided into 5 group based on the dose of oxycodone; 0, 0.05, 0.1, 0.15, 0.2 mg/kg.~     After giving each assigned dose of intravenous oxycodone, anesthesia was induced with~     thiopental and rocuronium. Heart rate (HR) and blood pressure (BP) was collected at baseline,~     before intubation, 1, 2, 3 minutes after intubation. The change of BP was calculated by~     (highest BP after intubation - baseline BP)/baseline BP.~   "
82710|NCT02484339|"~     Phase II open-label study to evaluate the efficacy and safety of Radium-223 dichloride in~     combination with external beam radiotherapy (EBRT) vs. external beam radiotherapy alone in~     the treatment of advanced castration resistant prostate carcinoma with limited bone~     metastases.~      To evaluate if time to radiological progression according to the Recommendations of the~     Prostate Cancer Clinical Trials Working Group published by Scher et al. (JCO 2008) (based on~     new lesions in bone scan and CT /MRI or death) of Radium-223 dichloride combined with EBRT is~     superior compared to EBRT alone.~   "
82711|NCT02484326|"~     The purpose of this study is to validate a practical risk score to predict the mechanical~     complication of ST-elevation myocardial infarction (STEMI).~   "
82712|NCT02484313|"~     Dairy products have a potential to be healthy snack foods for children. The purpose of this~     project is to investigate the short-term effects of Greek yogurt, a new popular dairy product~     on the regulation of glucose homeostasis, satiety and energy intake in normal weight and~     overweight/obese children.~   "
82817|NCT02482935|"~     The purpose of this study is to evaluate the amount of abemaciclib that reaches the blood~     stream and how long the body takes to get rid of it when given with and without food. In~     addition, the safety and tolerability of the study drug will be evaluated. Information about~     any side effects that may occur will also be collected. The study will last about 43 days for~     each participant, not including screening.~   "
82713|NCT02484300|"~     Our hypothesis is that oxidative stress induced during repeated apneas in obstructive sleep~     apnea (OSA) patients alters the neural control of breathing which destabilizes ventilatory~     control and exacerbates OSA. Thus antioxidant treatment has the potential to reduce OSA~     severity. Melatonin is a hormone which regulates sleep patterns, but it is also a potent~     antioxidant. Melatonin production is suppressed when the eyes register light so people with~     healthy sleep exhibit a peak in blood serum levels around 2am which then decreases towards~     morning. OSA patients exhibit lower melatonin levels with a later peak around 6am which then~     extends later into the day. This abnormal pattern is thought to compound difficulty falling~     asleep and daytime mental fatigue. Therefore the potential benefits of melatonin treatment in~     OSA patients are two-fold: most importantly via its antioxidant actions melatonin may reduce~     chemoreflex sensitivity, stabilize ventilatory control and reduce OSA severity; by~     normalizing sleep phase melatonin may also allow patients to fall asleep easier and wake more~     refreshed.~   "
82714|NCT02484287|"~     The purpose and/or hypothesis: To decrease the amount of external ventricular drain (EVD)~     related catheter infections by comparing the efficacy of Oklahoma University Medicine~     standard EVD catheters, both impregnated and non-impregnated, in three principle areas:~     incidence of infection, cost analysis, and average durations of placement, all while~     maintaining the standards of technique.~   "
82715|NCT02484274|"~     ID in children is the most frequent micronutrient deficiency in industrialized countries,~     including France. ID induces neurological impairment reducing cognitive, motor, and~     behavioral capacities in children in the short and long term.~      The purpose of this study is to evaluate the principal determinants of ID in France in~     two-year-old children and to improve strategies for prevention and screening.~      The main objective is to study the association between iron status in two-year-old infants~     living in France and the consumption of toddler milk formula after taking non-dairy iron~     ingestion, parental socioeconomic status and educational level into account.~      The secondary objectives are the following :~        -  to estimate the prevalence of ID and ID anemia in 2-year-old children living in France.~        -  to improve clinical tools for ID screening. to improve strategies for laboratory~          screening.~   "
82716|NCT02484261|"~     This study aims to monitor patients for relapse of the leukemia following allogeneic~     Hematopoietic Stem Cell Transplantation (HSCT) in order to identify patients early in~     relapse, with a low burden of disease, when interventions may be more successful by~     monitoring of peripheral blood lineage specific chimerism. Once disease has been confirmed,~     patients will initiate a novel combination of bortezomib and pravastatin.~   "
82717|NCT02484248|"~     This study is a double-blind, placebo -controlled, cross-over trial of ketotifen in children~     ages 8 through 17 inclusive that have a diagnosis of Functional Dyspepsia and have had~     continued pain despite acid reduction therapy in combination with montelukast. This study is~     147 days for subjects responsive to the ketotifen and 63 days for those who are not. The~     study includes scheduled visits including a physical, blood draws, and questionaires.~   "
82718|NCT02484235|"~     Obesity is a global health problem since it is associated with many cardiovascular and~     metabolic diseases, osteoarticular problems and some cancers. That is why it is a priority of~     the national health policies. Exercise is a mainstay in the treatment, but still the most~     effective method is sought. The resistance exercise and high intensity intervals (HIIT) have~     been shown to positively affect the outcome of the disease, increasing the oxidative capacity~     of the trained subjects. Therefore it is important to look if both together produce greater~     benefits or otherwise nullify its effects, such as suggested by recent publications in~     relation to the cellular response to different stimuli such exercise in skeletal muscle. The~     aim of this study is to evaluate the effectiveness of interventions exercise high intensity~     intervals, overload and combining them in the oxidative capacity of obese subjects.~   "
82719|NCT02484222|"~     The purpose of this study is to discuss the relationship between the result of fentanyl test~     and required dosage of morphine for children with OSAS after adenotonsillectomy；and to~     evaluate the ability of predicting requested dosage of morphine postoperatively.~   "
82720|NCT02484209|"~     1. Many patients with type 2 diabetes are not at glycaemic goal and require additional~          therapy in order to reduce vascular risk and improve symptom control~        2. Sulphonylurea therapy is a commonly prescribed 2nd-line glucose -lowering agent and its~          use is recommended in major clinical guidelines for diabetes and also in the recently~          presented IDF (International Diabetes Federation) guidelines for older people.~        3. Older people with diabetes are not a homogeneous group and as many as 25% are frail.~        4. Frailty is a PRE-DISABILITY state but may increase the 'vulnerability' of many older~          people to having a fall, admission into hospital, or perhaps increasing their risk of~          hypoglycaemia~        5. As a consequence of their glucose-lowering ability, sulphonylureas may increase the risk~          of hypoglycaemia in older people and those who have features of frailty may be at~          increased risk.~        6. The investigators therefore need to estimate the risk of hypoglycaemia in moderately~          frail older subjects with type 2 diabetes who are taking sulphonylurea therapy as this~          is a commonly prescribed class of agent used routinely in clinical practice~        7. Thus, this short term project wishes to assess the frequency of hypoglycaemia in~          subjects with some evidence of frailty with type 2 diabetes by a series of glucose~          monitoring techniques with excellent research team support to minimize any safety~          issues. An identical study at the Second University of Naples, Italy under the~          supervision of Professor Giuseppe Paolisso is planned and is the second study site for~          this PILOT project.~   "
82721|NCT02484196|"~     Endometriosis is a disease that affects different areas of individual functioning, including~     the area of sexual life. Women with endometriosis have an impairment of desire and sexual~     arousal, orgasmic capacity reducted because of the pain and deep dyspareunia. The aim of the~     study is to evaluate the effectiveness of surgery on dyspareunia in women with endometriosis,~     taking into account other variables involved in determining dyspareunia: the quality of the~     couple relationship, anxiety and depression, body image, coping strategies and resilience.~   "
82827|NCT02482805|"~     The purpose of this study is to determine whether power posing (i.e., holding poses~     associated with dominance and power), compared to submissive posing or rest, prior to~     exposure therapy for social anxiety disorder: 1) leads to a temporary increase in~     testosterone levels and/or 2) facilitates exposure therapy outcomes.~   "
82722|NCT02484183|"~     Pneumonia mortality rates in African countries like Malawi are high and increased further in~     children -exposed or infected with human immunodeficiency virus (HIV) as well as those that~     are severely malnourished or severely hypoxemic. Treatment innovations are needed. Bubble~     continuous positive airway pressure (bCPAP) improves oxygenation and ventilation and is a~     simple, relatively inexpensive adaptation of conventional continuous positive airway pressure~     potentially suitable for low-resource settings. bCPAP has been demonstrated to improve~     outcomes in neonates less than 1 month of age. Recently, a limited number of hospitals are~     using bCPAP to escalate pneumonia care for older African children failing standard treatment~     with antibiotics and oxygen. Supportive evidence for this approach is observational only.~     Quality randomized studies comparing bCPAP versus a standard-of-care control group that~     includes low-flow oxygen therapy and using a primary endpoint of mortality are not available~     in low-resource settings including high prevalence HIV countries like Malawi. Demonstrating a~     mortality benefit with bCPAP is needed to support further investment and scale up of bCPAP in~     the care of older Malawian children 1-59 months of age with World Health Organization (WHO)~     severe pneumonia complicated by HIV and/or malnutrition or severe hypoxemia.~      With the full support of the Malawi Ministry of Health and in collaboration with external~     experts from Lilongwe Medical Relief Trust and Cincinnati Children's Hospital Medical Center~     investigators plan to address this critical evidence gap by conducting a randomized~     controlled study determining bCPAP outcomes, compared to the currently recommended standard~     of care endorsed by the WHO and Malawi national pneumonia guidelines, in hospitalized~     Malawian children with WHO-defined severe pneumonia complicated by a co-morbidity ((1)~     HIV-infection, (2) HIV-exposure without infection, (3) severely malnourished) or WHO~     pneumonia with severe hypoxemia and without a co-morbidity. The investigators hypothesize~     that bCPAP will reduce the mortality of Malawian children with WHO-defined severe pneumonia.~   "
82723|NCT02484170|"~     30% mannitol cream has shown its ability to reduce the activation of the Capsaicin (TRPV1)~     (Transient Receptor Potential Vanilloid 1) receptor, a likely cause of the pain of~     post-herpetic neuralgia (PHN). This randomized placebo-controlled crossover study compares~     PHN pain one week before, for one week on the randomly assigned mannitol versus placebo cream~     and, after a three day washout, for one week on the other cream. Following this crossover~     study, participants receive mannitol cream for three months, and ,on request, for a further 9~     months. Pain levels will be checked to assess whether continued use of this cream~     significantly reduces the pain levels associated with PHN.~   "
82724|NCT02484157|"~     This study aimed to compare 2 activated clotting time analysers (Hemochron Jr vs. ACT Plus).~   "
82725|NCT02484144|"~     French study, multicentrique with the cooperation of several hospital centers . 700 patients~     (200 in the stage 1 and 500 in the stage 2). Every patient will complete questionnaires in a~     anonymous way.~   "
82726|NCT02484131|"~     The purpose of this study is to test the feasibility of the study protocol. The study~     protocol was designed to evaluate questions - Do educational materials improve dual x-ray~     absorptiometry (DXA) screening rates for women diagnosed with breast cancer and Does~     educational materials delivered by the participant's selected choice change DXA screening~     rates compared to the conventional mail method?.~   "
82727|NCT02484118|"~     The study purpose is to determine whether two different hemodialysis blood flow rates each~     meet national dialysis standards for urea clearance. Urea is used as the primary marker of~     dialysis adequacy. It is an experimental study with a crossover design of minimum 38~     participants. Participants will be selected from the accessible pool of end-stage renal~     disease clients at the Vancouver Community Dialysis Unit. The participants will dialyse at~     each pre-determined blood flow rate (320 mL/min and 380 mL/min) for two weeks each. Two forms~     of urea clearance data will be collected: one value that is routinely calculated by the~     dialysis machine and recorded on client treatment logs, and another that is calculated in a~     lab from blood samples.~   "
82728|NCT02484105|"~     Does comforting conversation during colonoscopy improve on patient satisfaction, compliance~     and pain management.~   "
82729|NCT02484092|"~     A Phase 1/2, Open-Label, Non-Randomized, Dose-Escalation Study of SPK-9001 in Subjects with~     Hemophilia B.~   "
82730|NCT02484079|"~     This study aims to investigate the comparative effectiveness between polyp removal with or~     without electrical current. The investigators want to include 800 polyps in the trial.~      It is known that polyps have the potential to develop to cancer if left in situ, but the~     investigators do not know the best way to remove them completely.~   "
82731|NCT02484066|"~     The purpose of this study is to evaluate the feasibility, efficacy and safety of~     transbronchial lung biopsy (TBLB) and bronchial brushing by using virtual bronchoscopic~     navigation (VBN) combined with endobronchial ultrasound (EBUS) and a Guide Sheath (GS) for~     the diagnosis of peripheral pulmonary lesions (PPLs) without radiographic fluoroscopy.~   "
82732|NCT02484053|"~     Rituximab is frequently used in adult and pediatric cancers, blood disorders, lymphoma (a~     cancerous growth made up of lymphoid tissue), graft-versus-host-disease (complication that~     can occur after a stem cell or bone marrow transplant), diseases of the immune system (the~     cells and substances that protect the body from infection) and rheumatologic conditions.~     Rituximab works by decreasing or temporarily eliminating a specific type of white blood cell,~     the B-lymphocyte. Overall, rituximab is generally well tolerated. The likelihood of an~     infusion-related reaction, or symptoms such as fever, chills, hives, low blood pressure or~     swelling, is very low, but highest during a patient's first infusion of rituximab and~     decreases with each additional dose. Adults commonly receive rituximab at a faster rate if~     they have done well with the first infusion, this study will help determine if the same~     approach is well tolerated in children.~      In this study, the investigators are testing a new method of administering rituximab which~     may reduce the time it takes to receive the medication. The initial ordered amount of~     rituximab will not change from the current standard of care (meaning what is usually done by~     doctors, and would likely be done if you were not on this study). The period of time over~     which rituximab is given is what is being studied.~   "
82733|NCT02484040|"~     The investigators compare two-week course of chemoradiation (33 Gy in 10 fractions with oral~     capecitabine) and conventional chemoradiation (50.4 Gy in 28 fractions with 5-FU and~     leucovorin) in this randomized trial.~   "
82757|NCT02483715|"~     Up to now, there is few randomized, large scale study prospectively and simultaneously~     comparing the efficacy, adverse effects and patient adherence of high-dose dual therapy~     (HDDT) and bismuth-containing quadruple therapy (BQT) as 1st-line regimens for H. pylori~     eradication.~      The aims of this study are:~        1. to compare the efficacy of HDDT, and BQT as 1st-line regimen in H. pylori eradication;~        2. to compare the patient adherence and adverse effects of these treatment regimens;~        3. to investigate factors that may influence H. pylori eradication by these treatment~          regimens.~   "
82828|NCT02482792|"~     The aim is to examine the effect of Norwegian Psychomotor Physiotherapy (NPMP) in employees~     with long-lasting musculoskeletal pain compared to employees receiving Cognitive Patient~     Education in combination with active individual physiotherapy (COPE-PT) on pain, function,~     quality of life and sick-leave~   "
82734|NCT02484027|"~     This study is randomized, open-lable, parallel-group and comparator-controlled. 456~     consecutive patients with acute ischemic stroke admitted within the first 72 hours after~     onset of symptoms will be studied. Those patients who will be randomly assigned to receive 2~     different treatment for the first 3 days of hospitalization(non-statin-therapy group) or to~     immediately receive rosuvastatin orally at a dose of 20mg daily (statin-therapy group). From~     the fourth day onward, rosuvastatin 10 mg daily will be administered in all patients. The~     total trial will be continued 12 months.~      mRS will be investigated at baseline, 3rd month, 12th month ;MMSE and Montreal tests will be~     investigated at baseline and 12th month. Laboratory data including serum lipids, Fg and~     hs-CRP.Among these, serum lipids will be tested at baseline, 8th day, 3rd month, 6th~     month,and 12th month; hs-CRP will be tested at baseline and 8th day, 3rd month; Fg will be~     tested at baseline, 8th day, 3rd month. Safety will be also assessed by adverse event reports~     and clinical laboratory data including CK-MB, renal and hepatic function at 3rd month, 6th~     month,12th month.~   "
82735|NCT02484014|"~     SEHER- Strengthening Evidence base on scHool-based intErventions for pRomoting adolescent~     health, seeks to develop and evaluate a school based adolescent health promotion intervention~     delivered by two different delivery agents viz. teacher-as-SEHER Mitra (TSM) and lay school~     counsellor called as SEHER Mitra (SM) in government-run secondary schools in Bihar, India.~     SEHER will implement a three armed clustered randomised trial (CRT) to evaluate the~     effectiveness and cost-effectiveness of these two models compared with the Tarang-Adolescence~     Education Programme (usual care) implemented by the State Government of Bihar. The hypothesis~     is that both interventions, compared to the control arm, will lead to a greater impact on~     school climate (school connectedness and relationship with teachers and fellow students). In~     addition, the interventions will increase the knowledge, attitude and awareness, and~     promoting healthy behaviours in youth on reproductive and sexual health outcomes, mental~     health and substance use, and gender related attitudes and violence. It is hypothesized that~     the addition of more resource intensive component (the SM arm) will be associated with the~     best outcomes.~   "
82736|NCT02484001|"~     This is a Phase III, multinational, open-label, non-controlled study with subjects under~     treatment in the double-blind BIA-2093-311 study (NCT01162460).~      Subjects will enter the open-label extension study after the preceding double-blind study was~     unblinded and they are attending their last Extension Phase Visit (EPV) of the double-blind~     study.~      For all subjects, the day of the last EPV of the double-blind study will also be the day of~     Visit 1 for the open-label extension study. All subjects will receive Eslicarbazepine acetate~     (ESL) under open-label conditions at Visit 1.~      The complete study duration including treatment with ESL under open-label conditions and~     follow-up is expected to last approximately 2 years (105 weeks).~      In case ESL as monotherapy will achieve MA prior to the end of 2017, the study may be~     discontinued prematurely within 42 days after achievement of MA.~   "
82737|NCT02483975|"~     Inhaled corticosteroids (ICS) have a number of known class effects including~     hypothalamic-pituitary-adrenocortical (HPA) axis suppression. Although the safety of inhaled~     Fluticasone Furoate (FF) on the HPA axis of adults and adolescent asthmatic patients has been~     established, it is important to assess the risk of suppression in children so as to establish~     whether this medicine can be safely used in this young population. This study aims to~     evaluate the effect of inhaled FF on the HPA axis of children 5-11 years of age (inclusive)~     with persistent asthma compared with placebo. Approximately 143 subjects will be enrolled.~     Subjects will enter a 7 to 14 day run-in period on oral montelukast 4 milligrams (mg) (5 year~     old subjects) or 5 mg (6-11 year old subjects) once daily. Eligible subjects will be~     randomized to receive once-daily FF inhalation powder 50 micrograms (mcg) or once-daily~     placebo inhalation powder in the morning via the ELLIPTA™ inhaler for 42 days. Subjects will~     continue to receive open label montelukast during the treatment period. All subjects will be~     provided albuterol/salbutamol inhalation aerosol, to use as needed to treat acute asthma~     symptoms throughout the study.~      ELLIPTA is a registered trademark of the GlaxoSmithKline group of companies.~   "
82738|NCT02483962|"~     Chronic Venous Insufficiency (CVI) occurs when the veins in the lower limbs can no longer~     sufficiently pump enough blood back to the heart. Symptoms may include: dull aching,~     cramping, itching or tingling in the calves, swelling, redness or any colour changes as well~     as thickening of the skin in the lower limbs. The most common indication of CVI is dilated~     veins known as varicose veins. CVI is a disorder found more commonly in females. Conventional~     treatments for CVI include vein ligation or stripping, elastic compression, valve~     reconstruction and sclerotherapy venous bypass. Amongst other treatment, exercise has also~     proven to be effective in improving CVI as it increases circulation, by increasing blood~     returning to the heart. A variety of herbal supplements have been proven to be safe and~     effective in the treatment of CVI. Red vine leaf extract has also been proven to be useful in~     the treatment of CVI. Previous studies on the red vine leaf extract have shown that it is an~     effective and safe treatment of CVI. Studies done on horse chestnut extract have stated that~     the extract increases venous tone and decreases capillary permeability. Butcher's broom~     extract has been proven to be effective in the treatment of CVI. There are currently no~     studies done on the combination of red vine leaf extract, butcher's broom extract, horse~     chestnut extract and vitamin B6.~      The aim of this study is to determine the efficacy of a combination of red vine leaf extract~     (360mg), horse chestnut extract (60mg), butcher's broom extract (35mg) and pyridoxine~     (vitamin B6) (3.2mg) in the treatment of symptoms associated with CVI, using a Venous~     Clinical Severity Score questionnaire (VCSS) .~   "
82739|NCT02483949|"~     To examine the effectiveness of a group-based lifestyle modification program followed by~     peer-led telephone counselling for type 2 diabetes (T2D) and cardiovascular disease risk~     reduction. The lifestyle modification program will support daily ambulatory activity and low~     glycemic index food intake among women with previous gestational diabetes mellitus (GDM).~   "
82740|NCT02483936|"~     The purpose of this study is to evaluate the non-inferiority clinical efficacy of two~     different drug associations in the essential hypertension control.~   "
82741|NCT02483923|"~     Ultrasound guided serratus anterior plane block may decrease acute postoperative pain and~     consumption of opioid after mastectomy.~   "
84430|NCT02461901|"~     This study evaluates whether patients with Clostridium difficile infection (CDI) who are~     treated with fidaxomicin have less contamination of their skin and surrounding environment~     with spores of C. difficile than patients treated with other drugs (metronidazole or~     vancomycin)~   "
82743|NCT02483897|"~     Corneal abrasions are associated with significant discomfort during a 24-48 hrs healing~     phase. Current practice guidelines discourage the use of topical anesthetics in treating~     these patients due to concerns that these medications may prevent proper corneal epithelial~     healing. These concerns are based primarily on decades old animal based research. However,~     recent evidence suggests topical anaesthetics are a safe and effective way of managing~     patient pain in the short term. This study will investigate the effect of topical 0.5%~     tetracaine on corneal healing and pain management in patients with corneal abrasions in the~     first 48 hours.~      This will be a prospective, double blind, randomized, controlled study of 260 adults with~     uncomplicated acute corneal injuries presenting to the tertiary acute care settings in~     Kingston. Patients will be randomly assigned to receive either 0.5% tetracaine or saline in~     addition to usual care as outpatients. They will be followed through the ophthalmology~     emergency eye clinic to assess healing at 36-48hrs. after the acute care visit. The primary~     outcome will be an assessment of pain as measured every 4 hours for 48 hrs. using a 10mm~     Visual Analogue Scale (VAS). Secondary outcomes will include assessments of corneal healing,~     use of adjunct pain medications, time lost from work/usual activities, quality of sleep,~     ability to read and the SF12 quality of life questionnaire.~      This study will better inform the safety and effectiveness of short-term tetracaine usage in~     patients with simple corneal abrasions for optimal treatment of patients in the future.~   "
82744|NCT02483884|"~     The aim of this study is to investigate safety and diagnostic performance of the 68Ga labeled~     PET tracer [68Ga]RM2 for detection and localization of primary prostate cancer confirmed by~     histopathology of the prostate as a standard of truth.~      This is an open-label, multi center PET/CT (positron emission tomography/computed tomography)~     non-randomized study. The study comprises 2 parts with an interim analysis after Part 1. In~     Part 1 a total of 30 subjects with biopsy-proven primary prostate cancer will be enrolled.~     Three strata of patients for the first part will be enrolled based on their pretreatment~     recurrence risk assessment according to the NCCN guidelines: 10 patients with low, 10~     patients with intermediate and 10 patients with high pretreatment risk of recurrence.~   "
82745|NCT02483871|"~     Patients will be treated in a dose escalation scheme to investigate a role for the addition~     of a statin in the treatment of estrogen receptor positive breast cancer. Patients will take~     oral rosuvastatin daily. The maximum number of patients evaluable for a DLT is 12. Dosing~     will be as follows: Cohort 1 - rosuvastatin 20mg, Cohort 2 - rosuvastatin 40mg. The patients~     will have a total of 4 blood draws and 4 breast biopsies. The breast biopsies will be~     collected to evaluate cholesterol metabolites and tumor microenvironment characteristics~     including gene expression profiling and metabolomics. Sampling will occur at study entry,~     week 4, week 8, and at the time of surgery in early stage patients or at week 16 for~     metastatic patients. Patients will begin endocrine therapy following the acquisition of week~     4 samples (blood and tissue biopsy).~   "
82746|NCT02483858|"~     This is an open-label, multi-center, non-randomized, dose escalation Phase 1 study evaluating~     safety, tolerability, PK (pharmacokinetics) and efficacy of PQR309 in the treatment of~     selected patients with advanced solid tumors.~   "
82747|NCT02483845|"~     Muscle biopsies of patients with Inclusion Body Myositis (IBM) have demonstrated a T-cell~     predominant inflammatory infiltrate, therefore, new agents targeting T -cell mediated cell~     death may be a novel treatment for IBM. Such an agent capable of preventing T-cell movement~     out of the vasculature, such as natalizumab, may be beneficial in IBM patients. Six patients~     will be recruited to participate in this phase I trial.~   "
82748|NCT02483832|"~     The main purpose of this study is to promote colorectal cancer (CRC) screening among~     individuals who have never been screened, with these individuals being members of a panel who~     participant in online studies. The primary study goals are to test effects of the matching~     between level of comparative risk feedback for colorectal cancer (CDC), that is, how one's~     risk compares to others, and message framing (Gain vs. loss frame) on CRC screening~     intentions and screening as well as mediators of effects in the context of people who obtain~     CRC risk feedback and framing messages online (i.e., Internet).~   "
82749|NCT02483819|"~     The purpose of this study is to evaluate the change of the hemodynamic profiles on bio~     reactance technique during TURP in elderly patients.~   "
82750|NCT02483806|"~     One lung ventilation (OLV) is essential during thoracic surgery. During OLV, intrapulmonary~     shunt can be increased resulting hypoxemia. Wang et al measured intrapulmonary shunt by~     transesophageal echocardiography. Although OLV technique had been advanced so far, hypoxemia~     during OLV reaches about 10% in spite of inspired oxygen fraction 100%. Applying~     PEEP(Positive End-expiratory Pressure) at dependent lung and CPAP at non-dependent lung can~     mitigate the hypoxemia. Above all, PEEP can be easily applicable. However, there are~     controversial studies whether it is supportive or not. In this prospective, cross-over study,~     the investigators are planning to investigate the effects of PEEP on intrapulmonary shunt,~     oxygenation and cardiac function as well.~   "
82751|NCT02483793|"~     The primary objective of this study is to evaluate the efficacy and safety tamsulosin in~     reducing stent discomfort in the pediatric population in the peri-operative period. The~     secondary objective is to compare the efficacy of tamsulosin with that of oxybutynin in~     reducing stent discomfort.~   "
82752|NCT02483780|"~     The proposed pilot community-based research project will examine the feasibility,~     acceptability, and potential efficacy of the Storytelling intervention compared with usual~     care in hypertension control among rural residents in 4 communities in Vietnam. This is a~     major clinical and public health problem in this developing country.~   "
82753|NCT02483767|"~     The study is a prospective randomized control clinical trial which is sponsored by the~     researchers. The purpose of this study is to determine the effectiveness of~     Gonadotropin-Releasing hormone agonist on ovarian function for premenopausal breast cancer~     patients during chemotherapy. The premenopausal breast cancer patients will be randomly (1:1)~     enrolled to receive standard chemotherapy with the GnRH agonist goserelin (goserelin group)~     or standard chemotherapy without goserelin (chemotherapy alone group). All patients are~     stratified according to age (<35years vs.36-44years), hormone receptor status (HR+ or ER+~     vs.HR- and ER-), chemotherapy regimen(3-4 cycles vs.6-8 cycles, and cyclophosphamide-based~     vs.noncyclophosphamide).The follow-up time will be at least 2years. The ovarian failure,~     follicle-stimulating hormone, estradiol and anti-Mullerian hormone, pregnancy outcomes and~     disease-free and overall survival will be compared between two groups to evaluate the~     effectiveness of protect against ovarian failure.~   "
82758|NCT02483702|"~     Blood transfusions are required for patients undergoing a craniosynostosis repair due to the~     significant amount of blood loss. Irradiated or non-irradiated transfusions have many risks~     involved including elevated potassium levels and graft versus host disease (TA-GVHD).~     Irradiated blood is able to destroy the leukocytes responsible for TA-GVHD, but it adversely~     causes elevated extracellular potassium due to hemolysis of the RBC's. When this blood is~     transfused, it may introduce too much extracellular potassium (> 6.5 meq/L) into the patient~     causing interference with the heart's conduction system significantly increasing the risk for~     hemodynamic changes, cardiac arrhythmias, and cardiac arrest. Hyperkalemia from rapid~     transfusions occurs much more frequently than TA-GVHD; however, both complications are~     under-reported.~      The study aims to evaluate the risk of irradiated versus non-irradiated blood in patients~     under the age of 6 months undergoing a craniosynostosis repair. This will be done by~     comparing the levels of extracellular potassium pre-transfusion, during transfusion,~     immediately after transfusion, and 30 minutes after the completion of transfusion. The~     investigators hypothesize that the patients who receive irradiated blood will have an~     increased extracellular potassium level compared to those who receive non-irradiated blood.~   "
82759|NCT02483689|"~     Patient will have usual appendectomy surgery with an injection of local or saline at incision~     site either before or after the incision at random.~      The clinical hypothesis of this trial is that pediatric patients who undergo a local~     anesthetic pre-incisional and/or post-incisional will reduce the amount of postoperative pain~     and therefore reduce the amount of analgesics required to keep the patient satisfied.~      Primary: To determine if local anesthetic reduces postoperative pain. Secondary: To assess~     the timing of local anesthetic injection affects postoperative pain.~   "
82760|NCT02483676|"~     Deficits in ankle control after stroke can lead to foot drop, resulting in inefficient,~     aberrant gait and an elevated falls risk. Using a novel ankle robot and newly invented~     adaptive control system, this study tests whether robotic-assisted treadmill training will~     improve gait and balance functions in chronic stroke survivors with foot drop impairment. It~     is hypothesized that, compared to treadmill training alone, integrating adaptive ankle~     robotics with treadmill training will reduce drop foot during independent overground walking,~     resulting in greater mobility, improved postural control, and reduced fall risk.~   "
82761|NCT02483663|"~     Scientists are examining the genetic and environmental influences on appetite and weight~     gain. The main purpose of this study is to look at how genetic and environmental factors may~     influence how the brain regulates appetite and food intake. Understanding how the brain~     regulates appetite and food intake may eventually lead to new ways to help people avoid~     obesity or lose weight.~   "
82762|NCT02483650|"~     The purpose of the Hyperbaric Oxygen Therapy Registry (HBOTR) is to provide real world~     patient outcome and side effect information from electronic health records submitted to a~     specialty specific hyperbaric registry as part of Stage 2 of Meaningful Use, including data~     provided to meet PQRS requirements via the registry's QCDR mission.~      Goals include understanding the value of HBOT among patients treated for a variety of~     conditions in relation to the frequency and severity of HBOT side effects. While randomized,~     controlled trials can establish the efficacy of treatments like HBOT, because they routinely~     exclude patients with co-morbid conditions common to those patients seen in usual clinical~     practice, the results of RCTs are usually non-generalizable. Real world data can be used to~     better understand the effectiveness of HBOT among typical patients, as well as the risks~     associated with treatment.~   "
82763|NCT02483637|"~     This study evaluates the safety of RejuvenAir Cryospray therapy to treat symptomatic chronic~     bronchitis patients with airflow restrictions.~   "
82764|NCT02483624|"~     This is a single center study of patients with inactive or mild SLE being performed to~     determine the safety, tolerability, and pharmacodynamics of DIM.~   "
82765|NCT02483611|"~     The magnesium sulfate and lidocaine have been increasingly used alone or in combination~     during anesthesia procedure to meet various objectives, such as reduction of pain, use of~     smaller anesthetic doses and stabilization of hemodynamic parameters.~      These medicines are often used in combination with neuromuscular blocking agents, which may~     contribute to the occurrence of residual block in some patients after anesthetic procedures.~     It was estimated that only 1-3 % of patients with residual block developing clinically~     apparent events. In a small proportion of patients, the consequences of residual blockade are~     very serious and even lethal. It is estimated that 40 % of patients with muscle paralysis~     come to the post-anesthesia care unit (PACU).~      Considering that: (a) magnesium sulfate and lidocaine are showing an increasing number of~     applications in various areas of medicine, (b) these medications stand out for their~     properties analgesic, anti-inflammatory, anti-arrhythmic, neuroprotective and capable of~     reducing the demand of anesthetics and opioids, (c) magnesium sulfate as lidocaine has been~     important part of the therapeutic arsenal to control a large number of diseases (d) the~     patient surgical surgery or potentially have benefited in particular from its effects, (and)~     these drugs have been used routinely in many medical services as well as adjuvants in~     anesthesia, (f) previous studies have shown that magnesium sulfate is able to prolong the~     duration of neuromuscular blockade by different types of muscle relaxants, with controversies~     about its effect on latency (g) the effect of lidocaine on the action of muscle relaxants in~     current literature have shown great controversy and (h) do not exist in the literature~     studies involving both drugs; the investigators aimed to investigate the effects of magnesium~     sulphate infused alone or associated with lidocaine on the neuromuscular blockade promoted by~     cisatracurium, as well as evaluate its possible hemodynamic repercussions. For this purpose~     the SM was infused in bolus, prior to tracheal intubation and continuously during the~     maintenance of general anesthesia; the Lidocaine, when associated and the Isotonic Solution~     were used in the same way and timeline as SM. As secondary objectives it has been proposed to~     evaluate if the Lidocaine with Magnesium Sulfate would be able to interfere with the~     hemodynamic stability of the patients in the study.~   "
82766|NCT02483598|"~     This study is to compare intestinal Cytochrome P450 3A4 (CYP3A4) activity in 9-18 month post~     weight loss surgery Roux-en-Y Gastric Bypass (RYGB) versus control subjects who have not had~     a weight loss surgery and are of similar age, gender, body mass index as the gastric bypass~     group. For this purpose, we will compare post-bariatric surgery patients with control~     subjects on alterations in systemic exposure of buspirone, a CYP3A4 substrate, when~     administered with grapefruit juice, a selective intestinal CYP3A4 inhibitor.~   "
82767|NCT02483585|"~     A Phase 3, Randomized, Double-blind, Placebo-controlled Study followed by open-label~     treatment phase. To evaluate the effect of AMG 334 compared to placebo on the change from~     baseline in monthly migraine days, in subjects with episodic migraine~   "
82788|NCT02483312|"~     This is a phase 1 study (the first stage in testing a new treatment to see how safe and~     tolerable the treatment is) which will include patients with acute myeloid leukemia (AML)~     that has either returned or has a more than a 70% chance of coming back and cannot have a~     bone marrow transplant.~      This study will see whether modifying a patient's AML cells to produce IL-12 and giving it~     back to the patient is safe and useful in patients with AML that cannot have bone marrow~     transplants.~   "
82768|NCT02483572|"~     Children with an intellectual disability often display severe destructive behavior (e.g.,~     aggression, self-injury) that pose risks to themselves or others and represent barriers to~     community integration. Destructive behaviors are often treated with behavioral interventions~     derived from a functional analysis, which is used to identify the antecedents and~     consequences that occasion and reinforce the destructive behavior. One treatment is called~     functional communication training (FCT), which involves extinction of destructive behavior~     and reinforcement of an alternative communication response with the consequence that~     previously reinforced destructive behavior. Results from epidemiological studies and~     meta-analyses indicate that treatments based on functional analysis, like FCT, typically~     reduce destructive behavior by 90% or more and are more effective than other treatments.~     However, many if not all of these studies have used within-subject experimental designs to~     demonstrate control of the treatment effects. Replication of the effects of FCT is typically~     shown on a subject-by-subject basis with relatively small numbers of patients (e.g., one to~     four patients). No study has demonstrated the effectiveness of FCT for treatment of~     destructive behavior across a large group of children.~      The goal of this study is to compare FCT (which is used clinically with the majority of the~     investigators' patients and is considered best practice for treating destructive behavior~     that occurs for social reasons [e.g., to access attention, preferred toys, or to escape from~     unpleasant activities]) to a waitlist control group across a large number of children with~     destructive behavior to evaluate the generality of FCT effectiveness. The investigators will~     evaluate rates of destructive behavior with each patient during a pretest baseline and again~     following FCT (approximately four months later) and/or the waitlist control duration (again,~     approximately four months later). All children assigned to the waitlist-control condition~     will be offered FCT services by the investigators' clinic at the end of the four-month~     waitlist period. These children will again be tested following four months of FCT (i.e.,~     posttest). Therefore, children assigned to the FCT condition will be tested twice (one~     pretest and one posttest), and children assigned to the waitlist-control condition will be~     tested thrice (one pretest, a second pretest following a four-month waitlist period, and one~     posttest).~   "
82769|NCT02483559|"~     The purpose of the study is to test the use of amber glasses at night as a method to block~     blue light from the eye, allowing the brain to produce a dim-light melatonin onset. The~     investigators hypothesize that blue-blocking will produce measurable benefits in subjectively~     and objectively rated sleep quality and mood as well as salivary melatonin levels during the~     night.~   "
82770|NCT02483546|"~     High fidelity Simulation has spread from anesthesiology to other disciplines such as internal~     medicine, pediatrics, and emergency medicine . Over the past decade, the use of simulation in~     medical education has increased exponentially. The term ''simulation'' spans a wide variety~     of formats, from the low-tech actor portraying a standardized patient to high-fidelity~     mannequin-based human patient simulation (HPS). HPS is able of both simulating realistic~     patient encounters and giving real-time, physiologically accurate feedback. Studies thus far~     show that use of simulation in training medical students and residents is helpful in~     strengthening students' knowledge and in evaluating their performance. Students appreciate~     simulation-based education as ''an opportunity to learn new skills in a safe environment .~   "
82771|NCT02483533|"~     LIPO-202-CL-23 is a follow-on study to evaluate the post-treatment safety and duration of~     clinical effect of LIPO-202 in subjects that completed either the LIPO-202-CL-18 or~     LIPO-202-CL-19 (parent studies). No risks related to treatment are anticipated as subjects~     will not receive additional treatment with LIPO-202 or Placebo for LIPO-202 in this follow-on~     study.~   "
82772|NCT02483520|"~     This clinical trial will test the FamTechCare intervention that uses multidisciplinary~     professional guidance based on in-home video monitoring to support family caregivers in~     managing challenging behaviors of persons with dementia (PWD). Families provide the majority~     of care for PWD at home. However the stress of caregiving is so significant that it increases~     caregiver morbidity and mortality. Stress is magnified by disruptive behaviors in PWD that~     frequently lead to nursing home placement. In-home video monitoring allows experts to assess~     behaviors of PWD and to identify antecedents, recommend specific interventions. FamTechCare~     uses new technology to link family caregivers to experts for guidance in managing disruptive~     behaviors, supporting continued care at home while reducing the negative effects of~     caregiving.~      Caregiver-PWD dyads (N=88) will be randomly assigned to intervention or control groups. Both~     groups will record behaviors during daily care for 3 months using a home monitoring unit.~     Notably, this new technology captures 3-5 minutes prior to the behavior, thus recording~     behavior triggers and precursors. Caregivers record care situations they select and upload~     videos to a secure site. The expert team will review intervention group videos weekly and~     will provide individualized feedback for improving care to caregivers in the home. The~     control group caregivers will receive a weekly phone call and advice from a nurse, but their~     recorded videos will be held for review and individualized feedback provided after 3 months.~      Study aims are to use observation to assist caregivers in behavior management. Effects on~     disruptive behaviors and caregiver burden and other negative outcomes will be compared.~     Investigators will evaluate ease of use and satisfaction, cost-efficiency, and factors~     influencing likelihood of translation into practice. This is the first study to test new~     technology for direct observation and immediate feedback to empower families to manage PWD~     behaviors at home while reducing caregiver stress and morbidity. Technology links caregivers~     to individualized expert guidance, acknowledging the importance and burden of their role.~     This study addresses NIH missions and the 2012 National Plan to Address Alzheimer's disease~     goals, integrating strategies to promote adoption and use of aging services technologies in~     interventions that will reduce negative caregiver outcomes, a growing public health problem.~   "
82773|NCT02483507|"~     Landmarks used to make a vascular puncture has long been based on the only knowledge of~     anatomy. This method assumes that the target vessel is in its expected position, permeable~     (non-thrombosed), and heavy enough to be catheterized. Any variations from these assumptions~     is likely to cause failures of puncture and complications. The development of ultrasound~     allowed to see the structures to achieve, whether before a puncture or in live for guiding~     the procedure. Visualization of vessels and adjacent structures has logically resulted in~     larger cases to a greater security of catheterization, improving the success rate, and~     decreasing complications. Several positions of the probe can be used to guide a puncture~     under ultrasound: the transversal approach in short axis, the long axis longitudinal approach~     and the oblique view approach.The aim of the study was to compare these three different~     ultrasound-guided approaches to peripheral vascular access in children. All children weighing~     less than 30 kg that should benefit from the introduction of an arterial catheter or central~     venous catheter introduced through a peripheral vein are eligible. Patients will be included~     after parent's and children's information and consent. The choice of the technique used~     (transverse, longitudinal or oblique approach) is determined by a randomization table.The~     puncture procedure is performed according to the usual protocols of the paediatric anesthesia~     unit of the investigators, under ultrasound guidance in a sterile manner. No time limit is~     required for the identification and implementation of the catheter. The position of the probe~     is dictated by the result of randomization and the Seldinger technique is used for the~     establishment of the catheter. Beyond two unsuccessful attempts, the procedure is considered~     as a failure. The anesthetist then uses the alternative technique of his choice. All~     anesthetists participating in this study exercised their main activity in the Montpellier~     University Hospital pediatric anesthesia unit. The laying of ultrasound-guided peripherally~     inserted central catheter and arterial catheter is part of the current activity of the unit.~   "
82774|NCT02483494|"~     Aim. To develop and examine the effectiveness of an APN-led telehealth rehabilitative~     programme as a transitional nursing therapeutic on readmission rates and health related~     outcomes amongst patients with Acute Myocardial Infarction (AMI) post discharge.~      Design. Randomized controlled trial with repeated measures.~      Methodology. A consecutive sampling of 172 patients with AMI will be recruited from a~     tertiary hospital in Singapore. Participants will be randomised into two groups. The~     experimental group (ALTRA) will receive APN-led telehealth rehabilitative programme upon~     discharge in addition to standard care. The control group will receive only standard~     follow-up care.~   "
82789|NCT02483299|"~     The purpose of this study was to determine whether combined treatment with liraglutide and~     metformin is more effective than metformin as monotherapy in the treatment of obese women~     with polycystic ovary syndrome (PCOS). We anticipated greater changes in body weight in~     patients on combined treatment than in those on monotherapy.~   "
84431|NCT02461888|"~     This study evaluates a new treatment combination of ixazomib with cyclophosphamide and~     dexamethasone in relapsed or refractory multiple myeloma. Participants will either receive~     ixazomib with cyclophosphamide and dexamethasone or cyclophosphamide and dexamethasone alone.~   "
82775|NCT02483481|"~     Sinusoidal obstruction syndrome (SOS) is a potentially fatal hepatic veno-occlusive~     disease-affecting children following bone marrow transplantation (BMT). SOS most likely~     develops secondary to sinusoidal endothelial damage and subsequent obstruction. The disease~     can be separated into mild, moderate, and severe forms; almost all patients diagnosed with~     severe SOS will die from this disease. Children with severe SOS suffer from multi-organ~     failure with signs and symptoms of portal hypertension (ascites, varices, edema), renal and~     respiratory failure . Although these children may be few and far between, the mere severity~     of the disease process and awful prognosis factors are valid reasons for more medical~     attention. SOS is usually diagnosed via clinical criteria and, despite available prophylaxis~     and treatment, children continue to die from this devastating disease.~      Quantitative shear wave ultrasound elastography with acoustic force radiation imaging is an~     emerging technology that uses ultrasound pressure waves to provide an estimate of tissue~     stiffness. This technique is promising for pediatric imaging because it is portable, quick to~     perform, relatively low cost and involves no ionizing radiation. Acoustic force radiation~     imaging and ultrasound elastography does not have any increased risks over conventional~     ultrasound imaging.~   "
82776|NCT02483468|"~     The primary objective of this study is to evaluate the effects of cognitive-behavioral~     therapy in combination with transcranial direct current stimulation in (1) improving pain and~     functionality, (2) reducing severity of opioid use disorders, and (3) reducing impairment in~     associated mental health areas (e.g., depression, anxiety, PTSD, sleep). The investigators~     will also determine the effects of treatment on neural activity in cognitive and limbic brain~     regions involved in pain regulation using functional magnetic resonance imaging (fMRI), and~     examine its relationship to opioid use severity.~   "
82777|NCT02483455|"~     This is a single-center, randomized, double blind, vehicle-controlled phase 2 study of~     subjects 8 years of age and older with Common Warts (Verruca vulgaris) who desire treatment.~   "
82778|NCT02483442|"~     Prospective, multicentre, cohort study assessing a diagnostic management strategy for~     suspected Pulmonary Embolism with independent central adjudication of outcomes~   "
82779|NCT02483429|"~     AVERT is a randomized controlled trial comparing video-oculography (VOG)-guided care to~     standard care to assess accuracy of diagnoses and initial management decisions for emergency~     department (ED) patients with a chief symptom of vertigo or dizziness suspected to be of~     vestibular cause. The trial will test the hypothesis that VOG-guided rapid triage (VRT) will~     accurately, safely, and efficiently differentiate peripheral from central vestibular~     disorders in ED patients presenting acute vertigo or dizziness, and that doing so has the~     potential to improve post-treatment clinical outcomes for these patients.~   "
82780|NCT02483416|"~     The study will take place over a period of 27 months. The recruitment phase will last~     approximately 24 months and each patient will participate for approximately 3 months.~      At the inclusion visit (D0), the investigator will ask the patient whether he would like to~     participate in the study and will obtain his written consent.~      Patients agreeing to participate will be randomised (3:1 ratio) and included in one of the~     following 2 groups:~      Group without `remote additional personalised nurse-led follow-up: patients will receive the~     healthcare given routinely by their medical team (100 patients).~      Group with `remote additional personalised nurse-led follow-up: patients will receive~     telephone calls from a nurse in addition to the healthcare given routinely by their medical~     team (300 patients).~      All the patients will be seen according to normal practice by the study medical team.~      Patients in the group with `remote additional personalised nurse-led follow-up will be~     contacted 8 times during the study (at D1, D7, D14, D21, D28, D44, D59 and D89). The nurse~     will make sure that the treatment takes place in good conditions; she cannot intervene in the~     medical care of the patient, nor give answer to the questions relative to the disease or to~     the treatment of the patient. The medical team remains the privileged contact of the patient.~   "
82781|NCT02483403|"~     Healthy elderly subjects male and female aged 65-85 will undergo MRI, lung function and~     exercise testing for the development of tools to quantify and validate longitudinal in vivo~     magnetic resonance imaging phenotypes of the aging lung.~   "
82782|NCT02483390|"~     The increasing awareness of the importance of palliative care has led, in Israel, to the 2005~     Law for the Rights of Persons with Terminal Illness. Still, problems of accessibility to~     palliative care remain unresolved. The use of e-health services is likely to expand the~     ability of the medical, psychosocial and nursing staff to reach patients who are either~     living in the periphery, are unable to make clinic visits or whose family members are~     housebound in order to be caregivers. This exploratory research is designed to explore the~     issues, barriers and advantages of e-health care through the perspective of the palliative~     care staff members, the patients themselves and their caregiving family members.~   "
82783|NCT02483377|"~     This research trial studies how well patient navigation and tailored treatment planning work~     in Latina patients with breast cancer. Patient navigation and tailored treatment planning may~     provide extra support by guiding patients through the healthcare system, remove barriers to~     care and provide ease of access to essential resources, encourage patient participation in~     their care, provide in-language summaries and plans for follow-up care, improve patient~     access to needed supportive care services and may improve general healthcare experience in~     Latina patients with breast cancer.~   "
82784|NCT02483364|"~     The purpose os this study is to evaluate the safety and effectiveness of HC-SVT-1001 in the~     surgical treatment of atrophic nonunion in long bones.~   "
82785|NCT02483351|"~     The purpose of this study is to determine the feasibility of conducting a large trial~     examining the effect on clinical outcome of a liberal red blood cell (RBC) transfusion~     strategy compared to a restrictive strategy (usual care) in patients with aneurysmal~     subarachnoid hemorrhage (SAH).~   "
82786|NCT02483338|"~     This study aims to evaluate the psychometric validity of FASS (Facial Summary Score Scale) to~     assess postoperative children pain.~   "
82787|NCT02483325|"~     Determine the efficiency of a myéloablative conditioning associating Fludarabine,~     Thymoglobuline, and intravenous Busulfan with adapted dose, according to a pharmacokinetics~     realized in the first day of administration (or J-6 of the conditioning) of the busulfan, in~     preparation for a allogenic transplant family or not family compatible HLA.~   "
82790|NCT02483286|"~     OBJECTIVES To determine the effects of 3 exercise interventions on sarcopenic indices among~     community-dwelling older adults with high osteoporotic fracture risks.~      MATERIAL AND METHOD The current study enrolled subjects who screened high risk of fall,~     osteoporosis/fracture by standardized questionnaires or FRAX. Subjects at the National Taiwan~     University Hospital Bei-Hu Branch (NTUHBB) were randomized into integrated care group (ICG,~     target n=50) and muscle training group (MTG, target n=50). Subjects from Lingko Chang Gung~     Memorial Hospital (LCGMH) were all assigned into X-box group (XBG, target n=30). All~     participants received a CD-ROM and a one education on osteoporosis, sarcopenia, frailty, fall~     prevention, nutrition, and coping strategy and another hour of professional led exercise~     program. ICG subjects received once weekly group exercise while MTG subjects received twice~     weekly machine-based resistence training on major muscle groups. XBG subjects rececived twice~     weekly exercise with X-box based programs. Major outcomes were muscle mass (measured by~     bio-impedance analysis), grip strength, walking speed, and lower leg extension power at~     baseline and after 12-weeks of intervention.~   "
82791|NCT02483273|"~     Study hypothesize that ocular microcirculation is reflecting cerebral perfusion. The purpose~     of this study is to evaluate ocular microcirculation in brain dead patients using side dark~     field (SDF) videomicroscope and compare it with microcirculatory parameters of healthy~     volunteers.~   "
82792|NCT02483260|"~     To provide an intravenous ribavirin therapeutic option for patients with a probable or~     suspected case of viral hemorrhagic fever, specifically Crimean-Congo hemorrhagic fever or~     Lassa fever.~   "
82793|NCT02483247|"~     This is an open label, multi-center, Phase 1/2 study of BBI503 administered in combination~     with selected anti-cancer therapeutics in adult patients with advanced cancer. The goal of~     the study is to determine the safety, tolerability, and RP2D of BBI503 in combination with~     each of the selected anti-cancer agents.~   "
82794|NCT02483234|"~     Purpose and rationale: To define the role of IL-17 as a mediator of structural bone lesions~     in psoriasis patients and patients with PsA. Primary Objective is the improvement of the~     PsAMRIS synovitis score baseline vs. week 24.~      Drug tested is Secukinumab 300 mg administered weekly for 4 weeks, then 4 weekly s.c. with a~     duration total of 24 weeks. Indication for this study is Psoriasis (Pso) and psoriatic~     arthritis (PsA).~   "
82795|NCT02483221|"~     Treatment of postoperative pain with hydromorphone (a strong analgesic) using~     patient-controlled analgesia with target-controlled infusion compared to conventional~     patient-controlled analgesia with morphine after elective cardiac surgery~   "
82796|NCT02483208|"~     The purpose of this study is to compare the pharmacokinetics of BAY81-8973 and Advate after~     intravenous administration.~   "
82797|NCT02483195|"~     The investigators propose to conduct a head-to-head, randomized clinical trial to compare the~     effectiveness of Minoxidil with Spironolactone and Finasteride in treating postmenopausal~     females with Androgenetic Alopecia (AGA).~   "
82798|NCT02483182|"~     This is a phase II, prospective, randomized, double-blind, parallel group,~     acyclovir-controlled clinical study to evaluate the safety, tolerability and preliminary~     therapeutic efficacy of ZEP-3 ointment 1.0% for the treatment of cold sores (Herpes~     labialis), following five consecutive treatment days with five times daily topical~     administration.~   "
82799|NCT02483169|"~     Through this study, the investigators are to prove that Cilostazol effectively prevent~     progression of intima-medial thickness in ischemic stroke patients with high risk of cerebral~     hemorrhage, along with no significant increase in the risk of occurrence of hemorrhagic side~     effects.~      The primary hypothesis of this study is; Cilostazol alone or with probucol will reduce the~     progression of intima-medial thickness compared to aspirin in the ischemic stroke patients~     with symptomatic or asymptomatic old cerebral hemorrhage.~   "
82800|NCT02483156|"~     Two Groups of Genotype 4 HCV Patients will participate through open-label randomized Study~     comparing Sofosbuvir tablet Plus Ribavirin tablet (Part A) versus single Dose (2 tablets) of~     EHCV containing Sofosbuvir, Ribavirin, and Natural anti-hemolytic (B) evaluating the safety~     and efficacy for both arms.~      Sponsor: Wadi El Nil Hospital~      Study Centers Planned: Approximately 2 sites in Egypt~   "
82801|NCT02483143|"~     Study objective:~      The purpose of this study was to compare the role of the prophylactic protocols~     N-acetylcysteine (NAC) plus normal saline, sodium bicarbonate (NaHCO3) plus normal saline and~     intravenous normal saline (NS) alone in the prevention of contrast-induced nephropathy (CIN)~     after computed tomography pulmonary angiography (CTPA) in emergency patients with suspected~     pulmonary embolism (PE).~      Materials and methods:~      This study was planned as randomized, double blind, placebo controlled clinical research.~     Patients presenting to the emergency department within a 1-year period, undergoing CTPA on~     suspicion of PE and having one or more risk factors for development of CIN were included in~     the study. The NAC group received 1 ml/3 mgr NAC+NS solution 1 h before CTPA and 1 ml/kg per~     hour for a minimum 6 h after CTPA. The NaHCO3 group received 132 mEq NaHCO3+NS solution for 1~     h before CTPA and 1 ml/kg per hour for a minimum of 6h after CTPA. The normal saline (NS)~     group received 3 ml/kg NS for 1 h before CTPA and 1 ml/kg per hour NS for a minimum 6 h after~     CTPA. CIN was evaluated as the primary outcome, and moderate renal injury (defined as a 100%~     increase in serum creatinine levels), severe renal insufficiency requiring hemodialysis or~     peritoneal dialysis) or in-hospital mortality as secondary outcomes.~   "
82802|NCT02483130|"~     A double-blind, placebo controlled, crossover study to determine whether a single dose of~     N-acetylcysteine (a nutritional supplement) can reduce brain glutamate levels in patients~     with a psychotic disorder. Secondary outcomes are to determine the pattern of alteration in~     brain perfusion and activity following a single dose of N-acetylcysteine.~   "
82803|NCT02483117|"~     The Clinical Impairment Assessment (CIA) assesses psychosocial impairment secondary to an~     eating disorder. The aim of this study was to create and validate a Spanish-language version~     of the CIA. Using a forward-backward translation methodology, we translated the CIA into~     Spanish and evaluated its psychometric characteristics in a clinical sample of 178 ED~     patients. Cronbach's alpha values, confirmatory factor analysis (CFA), and correlations~     between the CIA and the Eating Attitudes Test-12 and the Health-Related Quality of Life in~     ED-short form questionnaires evaluated the reliability, construct validity, and convergent~     validity, respectively. Known-groups validity was also studied comparing the CIA according to~     different groups; responsiveness was assessed by means of effect sizes.~   "
82805|NCT02483091|"~     To assess the feasibility of conducting a larger cluster randomized controlled trial to~     facilitate the effectiveness of a complex Knowledge Translation (KT) intervention, i.e.~     implementation of multimodal care, into chiropractic clinical practice, designed to improve~     the management of patients with Non-Specific Neck Pain (NSNP) disorders.~      To evaluate feasibility, the investigators will ascertain how well participating~     chiropractors and patients adhere to the study protocol and will solicit feedback from them~     about the overall usefulness of the content and format of the KT intervention. This study~     will determine planning for the main study and also the outcomes to be used as a primary~     outcome.~   "
82806|NCT02483078|"~     This is a Phase 2b/3, multi-center, two part study, designed to evaluate the efficacy,~     safety, and tolerability of PRO 140 in conjunction with existing ART (failing regimen) for~     one week and Optimized Background Therapy (OBT) for 24 weeks respectively. Study population~     includes treatment-experienced HIV-infected patients with CCR5-tropic virus who demonstrates~     evidence of HIV-1 replication despite ongoing antiretroviral therapy with documented~     genotypic or phenotypic resistance to ART drugs within three drug classes (or within two or~     more drug classes with limited treatment options).The options may be limited as a result of~     drug antiviral class cross-resistance or documented treatment intolerance.~   "
82807|NCT02483065|"~     People with dementia have complex medical, social, and psychological needs and can be~     exacerbated by physical illness and the complex relationships between health care systems,~     patients and their families or caregivers. They are a vulnerable and fragile population that~     differs significantly from the population without dementia. Therefore, the investigators~     propose the following objectives: 1. To describe the evolution of dementia patients admitted~     during the study period in two hospitals in the Basque Health Service-Osakidetza and~     complications associated with such admissions. 2. To compare with a control group (matched by~     type of pathology, age and sex and adjusting for other clinical variables (severity of~     dementia ...) the patient's condition before and after admission, in terms of quality of~     life, dependency, instrumental activities of daily living and severity of dementia. 3. To~     compare the length of stay, complications, mortality rate, the degree of dependency and~     quality of life of patients with dementia compared to those without dementia, matched by~     groups of pathologies, gender and age.~   "
82808|NCT02483052|"~     RejuvenAir System treatment will be performed during preoperative bronchoscopy 2 to 90 days~     prior to prescheduled lung resection in Subjects requiring lobectomy for removal of~     peripheral tumors. Treatment will be limited to areas of the bronchi within the lobe that~     will be removed, distal to the anticipated margin of resection. Treatment should be at least~     1 cm from the bronchial resection margins and away from the tumor bed. Treated airways will~     be inspected via bronchoscopy at the time of thoracotomy, and examined histologically~     following surgical resection. Subject participation will be from 1 to 90 days and enrollment~     is anticipated to take 3 months. Subject having a RejuvenAir procedure and not going on to a~     resection for any reason will be followed for a maximum of 90 days for safety and undergo~     bronchoscopic evaluation of the treated airways at 90 days (+/- 4 Days)) post treatment.~   "
82809|NCT02483039|"~     The primary objective is to evaluate the impact of an AKI Follow-up Clinic on major adverse~     kidney events (MAKE) in comparison to hospitalized patients surviving an episode of AKI who~     are not exposed to the AKI Follow-up Clinic intervention.~   "
82810|NCT02483026|"~     This study will examine the effect of providing a structured program of daily nutritional~     supplements for a 6 weeks of intervention prior to Sleeve Gastrectomy bariatric surgery on~     bone mass density status and formation of critical nutritional deficiencies years after the~     surgery.~   "
82811|NCT02483013|"~     Objective:The aim of this clinical study was to evaluate tooth color alteration (ΔE) and~     tooth sensitivity (TS) in patients that used two commercial brand-whitening dentifrices for~     four weeks. Sixty participants were selected in accordance with inclusion and exclusion~     criteria and randomly allocated in three groups (n=20): G1-Colgate Luminous White®, G2- Close~     up White Now® and G3- Sorriso® dentifrice (placebo). Then, participants received the~     instructions to use only the blinded supplied dentifrice and toothbrush to make the habitual~     oral hygiene, three times per day during four weeks. Evaluators assessed tooth color~     (CIEL*a*b system) and TS (VAS scale) at baseline and every week (assessment points 1, 2, 3~     and 4). Two-way ANOVA and posterior Tukey and Friedman test analyzed data (α = 0.05).~   "
82812|NCT02483000|"~     This phase I/II trial studies the side effects and best dose of anti-cluster of~     differentiation (CD)20 radioimmunotherapy (RIT), and to see how well it works when given~     before chemotherapy and stem cell transplant in treating patients with B-cell malignancies~     that have not responded to treatment or have come back after responding to treatment. CD20 is~     a protein found on the cells of a type of cancer cell called B-cells. Anti-CD20 RIT attaches~     radioactive material to a drug that is designed to target CD20, which brings radioactive~     material to the cancer cells to kill the cells. This may kill more tumor cells while causing~     fewer side effects to healthy tissue. Adding anti-CD20 to standard chemotherapy and stem cell~     transplant may be more effective in treating patients with B-cell malignancies.~   "
82813|NCT02482987|"~     The purpose of this study is to compare two barrier membrane products, Cytoplast (dPTFE) and~     BioXclude (human amnion chorion allograft), for their relative efficacies in dental socket~     preservation procedures, both when the socket is filled and overfilled with freeze dried bone~     allograft (FDBA).~   "
82814|NCT02482974|"~     This study aims to determine the safety and efficacy of conversion of sirolimus to everolimus~     in the maintenance treatment of LT recipients. Patients will be monitored every 12 weeks~     after the switch of treatment for 48 weeks. The laboratory tests including hematological,~     renal, hepatic, and metabolic parameters will be performed at each visit. Twenty-four-hour~     urine creatinine clearance and proteinuria will be determined from a 24-hour urine collection~     at baseline and week 48.~   "
82815|NCT02482961|"~     This study purposed to examine the adequate range of therapeutic concentration for Korean~     people by observing curative effects, side effects, blood concentration, etc. in treating~     CRAB-infected patients with colistin.~   "
82816|NCT02482948|"~     The purpose of this study is to compare how well two products, Active Leptospermum Honey~     (ALH) (MEDIHONEY® Gel) and Collagenase (Santyl®), in removing the nonviable (non living)~     tissue.~   "
82818|NCT02482922|"~     Purpose : Test the feasibility (acceptability, adherence) of a home-based interval exercise~     training (IET) and nutrition program, as well as its preliminary effects on resting heart~     rate, blood pressure, fasting glucose, HDL, cholesterol, weight and percent body fat, among~     primary care patients who have at least one risk factor for cardiovascular disease (CVD).~      Participants : 30 patients who receive care from the University of North Carolina (UNC)~     Family Medicine Center (FMC) and meet the inclusion criteria defined below (i.e. general FMC~     patients, not diagnosed with severe illness), will be enrolled to test the feasibility of the~     home-based interval exercise and nutrition program.~      Procedures (methods): A home-based IET and nutrition program will be piloted in 2 phases. In~     Phase I, 15 patients will be enrolled into the program, which will take approximately 3~     months. At baseline, data will be collected on age, height, weight, resting heart rate, blood~     pressure, fasting glucose, hemoglobin A1c, fasting lipids, cholesterol, insulin, percent body~     fat, cardiovascular fitness, and use a series of questionnaires to evaluate mood, sleep,~     hunger, and quality of life. At closeout, the investigators will measure patients' adherence~     to each component of the intervention. In Phase II, an additional 15 new patients will be~     enrolled in either the identical protocol, or a slightly modified intervention (if necessary~     based upon our results from Phase I). All patients will have the same variables measured at~     baseline during their study visit at 3, 6 and 12 months after enrollment into the study.~   "
82819|NCT02482909|"~     The purpose of this prospective randomized study is to compare the efficacy and safety of~     radiofrequency ablation and hepatic resection for small hepatocellular carcinomas with very~     homogeneous underlying conditions.~   "
82820|NCT02482896|"~     The study is a epidemiological, cross-sectional study in a mainly rural area of Denmark in~     Denmark. Life expectancy is shorter, morbidity is higher, and social problems more prevalent~     than in the urban areas of the country. The population study aims at examining complexities~     of environmental, hereditary, lifestyle, and social factors as determinants and predisposing~     factors for morbidity, health, and quality of life. The study will cover physical, mental,~     and social dimensions and examine family patterns and subgroups. The study will provide~     baseline information for later follow-up.~   "
82821|NCT02482883|"~     Subarachnoid haemorrhage (SAH) secondary to ruptured aneurysm represents 5 to 15% of all~     cases of stroke. The mortality rate of SAH is 40% and the risk of serious neurological~     sequelae among survivors is 10 to 20%.The causes of morbidity and mortality are mainly~     related to the initial damage induced by SAH and delayed cerebral ischaemia (DCI), which is~     generally secondary to cerebral vasospasm.~      Cerebral vasospasm is one of the main factors of poor prognosis after SAH, as it is~     associated with a 1.5- to 3-fold increase in the mortality rate during the 2 weeks following~     SAH in these patients.~      Despite a significant improvement in the time to management of this disease and the fact that~     the ruptured aneurysm is very often rapidly excluded by surgical or endovascular~     intervention, patients who survive the initial SAH remain at risk of severe complications~     over the following 2 weeks.~      Vascular stenosis of an arterial segment, called cerebral vasospasm, is observed in more than~     70 to 95% of cases on digital subtraction angiography between the 7th and 14th days after~     ruptured aneurysm. This angiographic vasospasm can be responsible for cerebral infarction in~     52 to 81% of cases.~      Despite 50 years of research, no clearly demonstrated effective treatment for vasospasm is~     currently available.~      This is a multicentre, randomized, comparative study, including 364 patients during the acute~     phase following ruptured aneurysm, in whom management is very often limited to control of~     complications, after exclusion of the aneurysm.~      The objective of this study is to validate the efficacy of transcutaneous trigeminal nerve~     stimulation for the prevention of vasospasm and limitation of the consequences of delayed~     cerebral ischaemia after SAH.~      This is an innovative project, as it comprises intervention in these patients prior to the~     development of complications and could limit the development of these complications. The~     prevention tool, based on external facial nerve stimulation, is a totally innovative,~     reversible and noninvasive technique. Use of nerve stimulation in this indication has never~     been previously reported and could radically modify the intensive care management of this~     disease over the years to come.~   "
82822|NCT02482870|"~     The investigators studied the efficiency of Macintosh laryngoscope and the King Vision video~     laryngoscope in adult patients scheduled for general anesthesia. Best Cormack-Lehane score~     obtained, glottic view time, intubation time, time to ventilation, correlation between the~     Mallampati classification and the Cormack-Lehane grades, and complications related to~     laryngoscopy and intubation has been investigated.~   "
82823|NCT02482857|"~     This is a single-center, open-label, randomized controlled trial. Patients with stable angina~     pectoris without use of dual antiplatelet therapy or anticoagulation therapy scheduled for~     coronary artery bypass grafting (CABG) at Karolinska University Hospital in Stockholm, Sweden~     will be eligible.~      This study investigates in patients having undergone CABG whether increasing the dose or the~     frequency of acetylsalicylic acid (ASA) treatment improves the efficacy of ASA regarding~     platelet inhibition compared to the standard dosing for cardiovascular prevention (75 mg once~     daily) in the first three months after surgery. Patients will be randomly assigned to~     postoperative ASA dose 75mg once daily, 75mg twice daily or 160 mg once daily. The study dose~     ASA will be started at hospital discharge and continued of three months. Blood samples for~     serum thromboxane B2 (TxB2) and other analyses will be taken before surgery, before~     discharge, and after one and three months. All available data will be collected~     prospectively. Informed consent will be obtained from patients meeting the inclusion criteria~     before the initiation of any study-specific procedures.~   "
82824|NCT02482844|"~     The replacement of the aortic valve by percutaneous approach (called TAVI) is a therapy which~     is booming in the management of aortic stenosis. It concerns patients who have a high~     surgical risk presenting comorbidity, for whom a classic approach by surgery of valvular~     replacement seems unreasonable. Beyond its feasibility, the implantation of a TAVI is less~     invasive and improves the patient's morbi-mortality. The appearance of a Left Bundle Branch~     Block (LBBB) is one of the most frequent complications of this procedure and represents an~     important risk of atrio-ventricular (AV) high grade conductive disorders requiring permanent~     pacing in 5 in 15 % of the cases in 1 year.~      De novo LBBB is associated with a more important morbi-mortality in post-TAVI situation.~     However, there are no predictive elements of these conductive disorders. Besides, the~     incidence and the deadline of appearance of this AV disorders are not established. It seems~     relevant to propose a new stratification based on ECG and endocavitary data. The monitoring~     of the conductive disorders is allowed by remote monitoring thanks to the implantation of a~     pacemaker or an implantable holter allowing to determine the incidence and the deadline of~     appearance of high grade AV conduction disorders.~   "
82825|NCT02482831|"~     This study aims to compare the sensory and motor block duration and the incidence of nerve~     injury after sciatic nerve block between diabetic and non-diabetic patients, and screen for~     the factors that may affect the block recovery.~   "
82826|NCT02482818|"~     The purpose of this study is to determine if Pregabalin, a medication used for the treatment~     of seizures and chronic pain, can be used to effectively treat people who suffer from~     non-asthmatic chronic cough (cough lasting over 8 weeks).~   "
82829|NCT02482779|"~     Health-related applications for smartphones represent a new and popular market for consumer~     oriented products. These applications are generally not considered medical devices and, as~     such, are not under the purview of the Federal Drug Administration. Some of these~     applications purport to measure vital signs, but do not have any published data to confirm~     accuracy of such measurements and their developers have not been willing to divulge the~     methods by which vital sign readings are produced.~      Use of unvalidated application derived data may contribute to patient harm as patients may~     make healthcare decisions based on the results these applications provide. This study aims to~     assess the accuracy of several such applications by comparing their findings to those of~     clinical vital sign monitors commonly used in the perioperative setting.~   "
82830|NCT02482766|"~     The primary hypothesis of this study is reduction in need of mechanical ventilation in the~     first 72 hours of life (excluding the transient tracheal intubation performed for surfactant~     administration and the mechanical ventilation for lung recruitment) in spontaneously~     breathing infants born at 24+0-27+6 weeks' gestation and failing nCPAP during the first 24~     hours of life who received an HFOV recruitment maneuver (IN-REC-SUR-E) compared to no~     recruitment maneuver (IN-SUR-E) just prior to surfactant administration followed by prompt~     extubation.~   "
82831|NCT02482753|"~     This study was to evaluate the efficacy and safety of Chidamide in combination with~     exemestane in postmenopausal patients with hormone-receptor positive advanced breast cancer.~   "
82832|NCT02482740|"~     The investigators design a phase 2, open labeled, randomized trial of Tamoxifen (20 mg/day)~     and Letrozole (2.5 mg) in treatment of squamous carcinoma of the cervix. Forty four patients~     with recurrent or persistent disease will be recruited, randomized, treated and followed~     three-monthly for 12 months. The primary end point is the treatment response rates. Secondary~     end points include survivals, ECOG performance status, quality of life and efficacy of~     biomarkers in predicting the responses. Candidate biomarkers including ER, PR, GPER and HPV~     genotype in paraffin cancer tissues as well as methylated genes in the blood will be studied~     in relation to the therapeutic outcomes.~   "
82833|NCT02482727|"~     Occlusion training, resistance exercise performed with a specialized venous tourniquet, leads~     to beneficial changes in muscle strength at low resistance and minimal stress on the nearby~     joint. This novel resistance training has the potential to greatly improve muscle strength~     gains in individuals who are unable, for medical reasons, to perform the high resistance~     exercises typically required to improve strength. Our study will examine the effect of this~     technique on strength recovery following distal radius fracture repair. The primary objective~     of the intervention is to achieve accelerated recovery of forearm, wrist and hand function as~     assessed using measures such as grip/pinch strength, validated questionnaires, and functional~     outcome testing. Occlusion training can potentially serve as a specialty intervention for~     rehabilitation patients, reduce the cost of care, and improve the treatment options for both~     patients and providers.~   "
82834|NCT02482714|"~     The primary purpose is the evaluation of life quality of Fibromyalgia patients. The~     investigators' main hypothesis includes the role of geographical, sociological, psychological~     and physical activity on life quality.~   "
82835|NCT02482701|"~     To confirm performance of the Captivator™ EMR device for resection of early neoplasia in~     Barrett's Esophagus.~   "
82836|NCT02482688|"~     Stroke is the number one cause of disability in the United Nations with about 1 million new~     cases each year. Following stroke, patients with perceptual and cognitive impairments have~     the worst prognostic outcomes. There is evidence to suggest that perceptual and cognitive~     symptoms can be alleviated by multisensory integration, which has the effect of enhancing~     motor, perceptual and cognitive processes. This research project will investigate for the~     first time the functional benefits that stem from multisensory stimulation of attention in~     stroke patients with perceptual and cognitive impairments. The research project will involve~     multisensory learning paradigms with stimulus and environmental parameters that optimally~     enhance perceptual learning and cognitive function. Multisensory learning paradigms will be~     tailored for patients with stroke to determine the perceptual and cognitive symptoms that can~     be alleviated, and fMRI will be used to evaluate the underlying neural substrates of the~     effects. The project will show whether multisensory stimulation provides an effective means~     of attentional rehabilitation after stroke and whether the effects generalize to everyday~     life, with long-term outcomes that improve functional independence in patients with stroke.~   "
82837|NCT02482675|"~     Cardiovascular disease (CVD) is the leading cause of death in the United States. Short-term~     increases in blood sugar, or postprandial hyperglycemia (PPH), affect blood vessel function~     and increase the risk of CVD. Greater intakes of dairy foods have been associated with a~     lower risk of CVD, but whether these effects occur directly or indirectly by displacing foods~     in the diet that might increase CVD risk is unclear. The health benefits of dairy on heart~     health are at least partly attributed to its ability to limit PPH and resulting PPH-mediated~     responses leading to vascular dysfunction. This provides rationale to further investigate~     dairy as a dietary strategy to reduce PPH and risk for CVD. The objective of this study is to~     define the extent to which dairy milk, and its whey and casein protein fractions, protect~     against postprandial vascular dysfunction by reducing oxidative stress responses that limit~     nitric oxide bioavailability to the vascular endothelium in adults with prediabetes.~   "
82838|NCT02482662|"~     Gestational diabetes mellitus (GDM) is an asymptomatic disease. Diagnosis is based on a oral~     glucose tolerance test (OGTT) requiring pregnant women to absorb 75g of glucose while fasting~     since midnight and to stay sober for another two hours. These OGTTs are poorly tolerated by~     pregnant women. As many OGTT are false positive according to self-monitoring blood glucose~     (SMBG), the investigators need now to determine the percentage of OGTT results that are false~     negative.~      The comparison of the two tests (OGTT and SMBG) in the same patient with normal results of~     OGTT will determine the exact percentage of false negative OGTT results.~      The opinion of women will also be taken into account. In the everyday clinic, many report~     that they prefer SMBG to OGTT because they do not have to be fasting, to drink non palatable~     drink and to attend a 2-hour visit in their schedule. However, no opinion study has yet been~     performed, the investigators will investigate formally what women think using a~     questionnaire.~   "
82839|NCT02482649|"~     The aim of this study is 1) to investigate clinical effects of equine-assisted activities and~     therapy (EAA/T) for treating attention-deficit/hyperactivity disorder (ADHD) and 2) to~     compare the clinical effect of EAA/T and drug therapy in children 6-13-years-of-age. This~     study is designed as a 12-week, prospective, open labeled trial, including 24 sessions of~     EAA/T. Forty six subjects will be enrolled and various clinical tests will be administered at~     baseline and after EAA/T or drug therapy.~   "
82840|NCT02482636|"~     This multicentre, parallel group, block randomised clinical trial aims to investigate the~     post booster antibody response in UK infants given a reduced priming schedule of~     meningococcal serogroup B vaccine and 13 valent pneumococcal conjugate vaccine. It will~     provide information about how best to include the meningococcal B vaccine (likely to be~     introduced late 2015) into the routine immunisation schedule.~      The UK Department of Health provides a routine vaccination schedule for children in the UK~     and are advised by the Joint Committee on Vaccination and Immunisation (JCVI). The Department~     of Health have announced that the meningococcal B vaccine (Bexsero) be introduced to the~     routine schedule as a 2+1 schedule. Cost effectiveness could also be improved by removing the~     current MenC conjugate vaccine dose given at 3 months of age. There is no published~     immunogenicity data for Bexsero when given at 2, 4 and 12 months of age (2+1 schedule) and~     with concomitant Infanrix/IPV/Hib which has now replaced Pediacel in the infant programme.~      This change to the schedule would result in three injections at 2, 4 and 12 months, and given~     previous reluctance among parents for three injections at one visit, an option to reduce~     PCV13 to a 1+1 schedule (priming dose at 3 months and booster at 12 months) will be assessed~     in this study.~   "
82841|NCT02482623|"~     Persons with dementia and their caregivers are often cared for in the community through home~     healthcare (HHC). While these patients and their caregivers need significant help and often~     have difficulty maintaining their quality of life, home healthcare clinicians are often~     unprepared to care for this population. This study will therefore examine the ability of an~     integrated, multi-pronged evidence-based practice intervention for home healthcare registered~     nurses, occupational therapists and physical therapists, the DSM-H, to improve the quality of~     care and quality of life for persons with dementia and their family caregiver. The~     investigators will enroll persons with dementia and their family caregiver upon admission to~     the HHC agency and examine their quality of life over 60 days following admission, comparing~     those who receive the intervention to those who serve as controls.~   "
82842|NCT02482610|"~     Cardiovascular disease (CVD) is the leading cause of death in the United States. Short-term~     increases in blood sugar, or postprandial hyperglycemia (PPH), affect blood vessel function~     and increase the risk of CVD. Greater intakes of dairy foods have been associated with a~     lower risk of CVD, but whether these effects occur directly or indirectly by displacing foods~     in the diet that might increase CVD risk is unclear. Further controversial is the extent to~     which dietary fat derived from dairy foods regulate the risk of CVD. The health benefits of~     dairy on CVD risk are at least partly attributed to its ability to limit PPH and resulting~     PPH-mediated responses leading to vascular dysfunction. This provides rationale to~     investigate full-fat containing dairy as a dietary strategy to reduce PPH and risk for heart~     disease. The objective of this project is to define the extent to which full-fat dairy milk~     compared to non-fat dairy milk protects against PPH-induced vascular dysfunction by reducing~     oxidative stress responses that limit nitric oxide bioavailability to the vascular~     endothelium in adults with prediabetes.~   "
82843|NCT02482597|"~     Whole-body periodic acceleration (WBPA) is a new, non-invasive, and promising therapy for a~     diverse and growing list of disorders including cardiovascular disease 6. During WBPA,~     patients lie in the supine position on a bed that is capable of translating back and forth~     parallel to the ground, along the head-to-foot axis of the patient. Thus, this treatment is~     best described as a form of passive exercise. The frequency of the translation (up to 180~     cycles/minute; cpm) as well as the distance traveled (2-24mm) by the bed can be adjusted by~     the patient or health care professional.~      The science behind the therapeutic effects of WBPA still remains largely unknown.~      The objective of this study is to determine if WBPA may be used as an effective way to reduce~     lactic acid concentrations during recovery after intense exercise more rapidly than~     previously established methods.~   "
82844|NCT02482584|"~     The purpose of the trial is to investigate the effects of three months' treatment with a~     CPAP-device versus control group on change in arterial stiffness in type 2 diabetes (T2D)~     patients with newly detected Obstructive Sleep Apnoea (OSA).~   "
82845|NCT02482571|"~     The primary objective of this research is to measure changes in neurochemical concentrations~     during stimulation of the primary visual cortex, in both conditions of normoxia (normal~     oxygen availability) and induced mild hypoxia (reduced oxygen availability).~   "
82846|NCT02482558|"~     The aim of this study is to investigate the effect of a one week high versus low glycaemic~     index dietary intervention on hepatic glycogen and lipid levels and blood hormone levels in a~     two way cross overs study and to see if there is any correlation between this and satiety or~     appetite.~   "
82847|NCT02482545|"~     Purpose: To evaluate the effects of replacing breakfast with a high protein, high fat, high~     fiber meal replacement in overweight individuals, on body composition.~      Participants: Healthy, overweight and obese individuals (ages 18-45 yrs) with no history of~     disease. Procedures (methods): In a randomized control intervention, subjects will complete 5~     different testing sessions (pre-screening, 2 baseline testing sessions, and 2 post testing~     sessions) as well as an 8 week intervention period. Pre-screening will include written~     informed consent, health history questionnaire, nutrition analysis, and baseline~     anthropometric measures. Baseline testing will be split into two sessions and include~     measurements of resting metabolic rate (RMR), body composition, blood and saliva hormones,~     mood, satiety, and health related quality of life questionnaires, and a cardiorespiratory~     fitness assessment.~      Subjects will be randomly assigned to treatment (8 week supplementation with meal replacement~     to be taken at breakfast) and control groups (continue normal eating habits) with 4~     electronic correspondences throughout the supplementation period. All measures will be~     repeated in two post-testing sessions.~   "
82848|NCT02482532|"~     The researchers will investigate if modified T-cells from a patients own system can be~     utilized to find and destroy metastatic melanoma tumor and thus improve patient outcomes.~   "
82849|NCT02482519|"~     Marrow adipocytes have been identified as a component of the bone marrow micro-environment.~     Evidence exists suggesting that marrow fat plays an important physiologic role in both bone~     mineral and energy metabolism in humans. The investigators will study the effects of acute~     weight gain and acute nutritional deprivation on energy homeostasis and bone mineral~     metabolism by examining marrow adiposity, peripheral fat depots and bone microarchitecture.~      The study will include two ten day inpatient study visits. Participants will eat a high~     calorie diet for 10 days, followed by a 13-18 day stabilization period at home, and then~     return for a ten day fast.~   "
82850|NCT02482506|"~     This is a randomized intervention study to examine the effects of the Moving Forward Guided~     Weigh Loss Intervention compared to a self-guided weight loss program on BMI and behavioral,~     biological, and psychosocial outcomes in overweight and obese African American women~     diagnosed with Stage I, II, or III breast cancer.~   "
82851|NCT02482493|"~     Total knee arthroplasty (TKA) is one of the most commonly performed orthopaedic procedures.~     Approximately 84,000 knee replacement procedures were recorded in the UK in 2012. The main~     goal of TKA is to relieve the disabling pain of arthritic disease.~      Patient satisfaction following TKA is related to quick recovery and return to daily~     activities. This can be dependent on the design of the implant used in the knee. Improvements~     in implant design and surgical technique mean many modern designs offer implant survival~     rates beyond 10 - 15 years.~      As cost pressure increases in the NHS the unit cost of implants is now being scrutinised,~     particularly with regard to cost effectiveness. The Press-Fit Condylar (PFC) Sigma implant~     can be used with either a conventional metal backed or alternatively an all polyethylene~     tibial component (part fitted to the shin bone), the latter considerably cheaper to~     manufacture. Four small prospective randomised trials and one large regional registry study~     with long follow up support the safe use of all polyethylene tibial components in TKA. The~     investigators will therefore undertake a prospective randomised controlled trial comparing~     the results of all polyethylene tibial components with those of conventional metal backed~     tibial components in patients aged 75 or over, comparing both clinical outcome and~     radiological survivorship.~      The type of knee replacement used for each patient (metal-backed or polyethylene) will be~     chosen at random once a patient has agreed to take part in the study.~      Data will be collected by means of follow-up appointments and questionnaires and clinical~     tests both before the operation 1 year, 2 years and 5 years postoperatively. This will allow~     us to see how both types of knee replacement perform over time and if one performs better~     than the other in terms of patients movement, pain and functional activities.~   "
82852|NCT02482480|"~     Study objetives : The aim of this study is to assess the impact of a combined therapy~     treatment (physical exercise, oropharyngeal exercises and dietary recommendations) on~     symptoms and quality of life in patients with OSAS, as an alternative or addition to~     therapeutic treatment with nocturnal CPAP.~   "
82853|NCT02482467|"~     Puberty and long-term ovarian function of patients with a ovarian prenatal cyst has not~     described to date.~   "
82854|NCT02482454|"~     The purpose of this study is to determine whether combining of radiofrequency ablation (RFA)~     and cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with~     cholangiocarcinoma.~   "
82855|NCT02482441|"~     This is an open-label Phase 1a/b dose-escalation study to assess the safety, tolerability,~     and PK of OMP-131R10 as a single agent for advanced solid tumors and in subjects with~     metastatic colorectal cancer.~   "
82856|NCT02482428|"~     The LFX453X2202 study tested the investigational drug LFX453 against placebo for safety,~     tolerability, and efficacy in treating genital warts in circumcised men, in parallel with an~     additional open label arm using imiquimod 5%.~      During the study the patients received either LFX453, placebo or active comparator and the~     tolerability and safety was assessed continuously through local tolerability assessments and~     adverse event recorded. Efficacy was clinical evaluations and lesion count. During the study~     biopsies were taken for analysis of pharmacokinetics and biomarkers. Blood samples were taken~     for safety, pharmacokinetics (PK), and biomarkers.~   "
82857|NCT02482415|"~     Health care systems are increasingly using outpatient care for patients with advanced cancer~     disease with complex needs, limited life expectancy, and need for palliative care. Family~     caregivers are centrally important, but are often insufficiently prepared for the caregiving~     role, and experience psychological distress and physical symptoms. We hypothesize that a~     psycho-educational intervention during ongoing palliative care will support family~     caregivers' wellbeing and decrease negative consequences of caregiving.~      The intervention, which has been developed in steps through a series of studies based on~     theoretical, methodological, and empirical work, was delivered in a group format 2013-2014.~     Family caregivers were invited to meet in a group for 2 hours once a week for 3 weeks. Each~     meeting had a specific topic presented by a member of the palliative care team (physician,~     nurse, and social worker). The meetings addressed multi-dimensional issues in dialogue with~     the participants.~      The overall aim of this ongoing project is to investigate short and long-term effects of the~     intervention delivered by health professionals at ten specialized palliative home care units.~     Multiple methods are now being used, including a randomized controlled trial (RCT). In total,~     270 family caregivers have been requested to answer a questionnaire at four time points: at~     baseline, upon completion and again 2 months after completion of the intervention, and 6~     months after the patient's death. The primary outcome variable is preparedness for~     caregiving, and the secondary outcome variables cover aspects of wellbeing including~     competence and reward, caregiver burden, health, anxiety and depressive symptoms, and grief.~     These data will be complemented with interviews.~      The project has the potential to contribute knowledge about the development of support for~     family caregivers, not only in specialized palliative care but also in other contexts such as~     elderly care and general home care services.~   "
82858|NCT02482402|"~     Trial Rationale/ Justification To assess efficacy and safety of inhaled Iloprost in treatment~     naïve patients with left heart failure and pulmonary hypertension, who are on the waiting~     list for orthotopic heart transplantation. As patients often show increasing hemodynamic~     values while waiting for a donor organ, the transplantation becomes infeasible at the time of~     identification of an appropriate donor organ when reaching the exclusion limits. Therefore,~     there is a high need of improvement and stabilisation of the patients' hemodynamic values as~     PVR, PAP and TPG. In a retrospective, non-controlled study inhaled Iloprost has already shown~     a beneficial effect on the hemodynamics as reduction of PVR, TPG and CI (Schulz 2010).~     Treatment with inhaled Iloprost could stabilize the hemodynamics and prevent the patients~     from being classified as ineligible by the time an appropriate donor organ is identified.~      However, the adverse event profile regarding frequency, time-dependency has to be further~     validated to show safety and tolerability of inhaled Iloprost in this indication.~      All patients can be transferred to a long-term medically supervised observation period with~     inhaled Iloprost therapy.~   "
82859|NCT02482389|"~     This protocol seeks to utilize a novel method of tumor bed boost delivery and to better~     understand breast cancer radiation response through the analysis of pre-and post-radiation~     breast tumor samples.~   "
82860|NCT02482376|"~     This protocol seeks to build on the favorable results of the investigators' phase I trial~     (Pro00015617) by extending the findings to a larger cohort of subjects.In this study, the~     investigators hypothesize that 21Gy (Gray) as a single fraction can be delivered~     preoperatively to a larger group of subjects (n100).~      The primary objective is to determine physician reported rates of good/excellent cosmesis at~     baseline and 6 months, 1, 2, and 3 years post-treatment as measured by the NRG cosmesis scale~   "
82861|NCT02482363|"~     Season of birth influences pregnancy for reasons that remain unclear however the answer may~     lie in the amount of sunshine pregnant women are exposed to. Sunshine, or ultraviolet light~     (UV) exposure is already known to have benefits for health on heart disease, strokes and~     depression. In pregnancy, relationships between sunshine exposure are evident in birth~     weight, preterm birth and risk of blood pressure complications. Vitamin D, the UV generated~     hormone, was thought to be responsible when low vitamin D levels were associated with these~     pregnancy complications. However, vitamin D replacement is ineffective at preventing these~     outcomes, and the investigators hypothesise that this is because it is the UV that is~     beneficial for pregnancy and it is working through a different pathway.~      A new understanding of skin function is central to this, with a 2014 study showing that~     exposing an adult to 20 minutes of low dose UV light lowered their blood pressure and~     improved blood flow. These investigators demonstrated this was a direct effect of UV on the~     skin and was mediated by nitric oxide, a chemical central to many aspects of pregnancy~     including blood pressure regulation and uterine activity.~      The investigators in this study have funding from Tommy's to investigate if a similar effect~     is seen in pregnancy on the circulation. The design is similar to the previously successful~     method and volunteers would be recruited from clinical areas during the second trimester. As~     both resting and warming for 20 minutes have the potential to have similar effects on the~     circulation, a control arm will expose participants to these without the UV.~      This pilot study would involve one visit and measurements taken would include heart rate,~     blood pressure, arteriography, ultrasound of the uterine arteries and blood measurements of~     nitric oxide levels. Arteriography is performed using a specialised arm cuff and is safe and~     non-invasive. A subset of these women would be invited to repeat this in the third trimester~     to investigate for a difference in effect at a later gestation.~   "
82862|NCT02482350|"~     Hemianopia refers to compromised vision in one half of the visual field, in either one or~     both eyes. Hemianopic Alexia (HA) is a reading disorder related to such impairment, usually~     caused by stroke or head injury. In order to read, participants have to move their eyes along~     a line of text three to four times per second. Such eye movements are called saccades. One~     makes use of peripheral visual information to the right (if reading from left to right, e.g.,~     in English) or to the left (if reading from right to left, e.g., in Arabic) of words. HA~     patients are deprived of much of this information. Patients with HA require far more~     saccades, which slows their reading significantly and often prevents them from reading~     efficiently for work or pleasure. It follows that the reading ability of those who read~     left-to-right would be compromised more by right-sided HA, and in those who read~     right-to-left by a left-sided HA. This study proposes to explore the rehabilitation of~     left-sided HA following stroke, in Arabic readers. An online treatment package has been~     developed in English (http://www.readright.ucl.ac.uk/). Currently, no assessment or treatment~     resources exist for the condition in right-to-left readers. The aim is to develop novel~     Arabic reading tests and rehabilitation material. The current project proposes to 1)~     translate this package into Arabic, 2) develop new Arabic reading test materials and 3)~     collect data from Arabic reading stroke patients in a Phase 2 clinical trial. The hope is to~     develop an effective, novel, and empirically supported reading treatment package for Arabic~     readers with HA.~   "
82863|NCT02482337|"~     The purpose of this study is to show that the Per-Oral Endoscopic Myotomy (POEM) procedure is~     an effective treatment for people with achalasia.~   "
82864|NCT02482324|"~     This is an open-labeled, cross-over design, pharmacokinetic study, to determine the~     pharmacokinetics of ALZT-OP1 (a combination drug therapy) designated as ALZT-OP1a and~     ALZT-OP1b, in both plasma and CSF, following co-administration of the active compounds, in~     healthy volunteers, aged 55-75, and in good general health.~   "
82865|NCT02482311|"~     This is an open-label, multi-centre, Phase Ib study of AZD1775 designed to assess the safety,~     tolerability, pharmacokinetics, and anti-tumour activity of AZD1775 monotherapy in patients~     with advanced solid tumours.~   "
82866|NCT02482298|"~     The purpose of this study is to determine whether ticagrelor is effective in reducing the~     number of days of pain, intensity of pain, and reducing the use of analgesics due to sickle~     cell disease~   "
82867|NCT02482285|"~     This study is looking at the feasibility of performing frailty assessments on elderly~     patients with advanced cancers~   "
82868|NCT02482272|"~     The purpose of this study is to compare efficacy and safety of continuing Lamivudine plus~     Adefovir or Adefovir versus switching to Entecavir plus Adefovir in patients with~     LAM-resistant chronic hepatitis B who have suboptimal response to Lamivudine plus Adefovir or~     Adefovir~   "
82869|NCT02482259|"~     This study is looking at the feasibility of performing frailty assessments on patients with~     advanced hepatocellular cancer.~   "
82870|NCT02482246|"~     Healthy parturients presenting for scheduled cesarean delivery will have blood drawn and~     measured for microparticles at baseline, immediately after delivery, and at several time~     points thereafter.~   "
82871|NCT02482233|"~     The purpose of this pilot randomized trial is to determine the feasibility of e-cigarettes~     and telephone counselling (compared to transdermal nicotine replacement and telephone~     counselling) as a harm-reduction tool that may lead to increased smoking cessation in the~     perioperative setting in smokers presenting for elective surgery at the San Francisco~     Veterans Affairs Medical Center. Secondary outcomes include acceptability of e-cigarettes~     over transdermal nicotine replacement, length-of-stay in the post-anesthesia care unit,~     hospital length-of-stay, postoperative complications within the first 30-days, and smoking~     status 8-weeks after randomization. This pilot study is designed to provide the preliminary~     data necessary to plan and fund a larger-scale randomized clinical trial that will assess the~     utility of e-cigarettes in achieving smoking cessation perioperatively. Our ultimate goal is~     to add to the limited existing data on the safety and efficacy of e-cigarette use in smoking~     cessation, specifically in the perioperative setting where the risks of continued smoking are~     great and the motivation to stop is high.~   "
82872|NCT02482220|"~     Acute exercise of high intensity has been shown to induced nutritional adaptations in obese~     adolescents. Indeed, several studies have shown that about 30 minutes of intensive exercise~     (above 70% of the adolescents maximal aerobic capacities) can favor reduced-energy~     consumption at the following meal with no modification of their appetite feelings. Although~     it is suggested that chronic physical activity programs can induce energy intake~     modifications, this has never been clearly studied. The aim of this work is to compare~     different physical activity programs (low vs. high intensity programs) in terms of energy~     intake, appetite feelings and appetite-regulating hormones, in obese adolescents.~   "
82896|NCT02481908|"~     The aim of this investigation was to assess the value of Systolic Time Intervals (STIs) as a~     method of detecting Left Ventricular Dysfunction (LVD) in patients admitted to the ED for~     Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) and whether STIs~     measured under Valsalva manoeuver (VM) could improve the distinction between patients with~     LVD and those without LVD.~   "
82873|NCT02482207|"~     Investigators recently demonstrated that coronary flow reserve (CFR) significantly improved~     after rosuvastatin therapy in hypertensive patients with average levels of serum cholesterol~     by measuring the change in CFR after 1 year treatment with rosuvastatin in the RESERVE~     (Rosuvastatin Effect on Coronary Flow Reserve in Hypertensive Patients) I trial. However, the~     absence of a placebo group made it difficult to exclude the possibility that lifestyle~     modification and antihypertensive medication also played a role in improving CFR in our~     previous study. In a double-blind, randomized trial, investigators try to examine the~     hypothesis that rosuvastatin added to lifestyle modification will be superior to lifestyle~     modification alone in improving CFR in hypertensive patients .~   "
82874|NCT02482194|"~     The conventional treatment of spinal cord injury (SCI) includes physical therapy and~     rehabilitation and in some cases may require surgical intervention. Although improved~     emergency care and aggressive treatment can help in preventing further damage and even~     restore minimal sensory functions, still a large proportion of patients suffer with prolonged~     disabilities. It led neurologists to search out for new treatment options for this otherwise~     debilitating disorder. Recent advances in research have developed a better understanding of~     stem cell biology especially their role in tissue repair and regeneration. Encouraging~     results in pre-clinical phase and limited human trials have proved that stem cells can be~     safely and effectively delivered to the injured site for regeneration of damaged tissue.~     Although a variety of cell types have been tried for their role in repair of spinal cord~     injury, majority of clinical trials employed stem cells taken from bone marrow especially~     mesenchymal stromal cells (MSC). Bone marrow MSCs are a good choice for regenerative~     therapies owing to advantages like ease of collection and ex-vivo culturing, immune tolerance~     and their ability to differentiate into a variety of cell types including neuronal lineage~     cells. Intravenous application or direct injection of MSCs into cerebrospinal fluid (CSF) via~     lumber puncture in animal models of SCI and brain trauma had shown that MSCs can migrate~     towards and integrate into injured spinal tissue and reduce cyst size and increase functional~     recovery. The literature indicates that acute, sub-acute and chronic injury can be a~     therapeutic target for MSC grafting. The mechanism of action may however vary among these~     conditions. In acute phase, MSC administration play anti-inflammatory role, while in~     sub-acute/chronic setting it may be used as neurostimulator and for cell bridging effect and~     possibly glial or neuronal cell replacement. The investigators propose a non-randomized,~     single group, open label, phase-I, interventional study to evaluate the safety and efficacy~     of intrathecal delivery of patient's own (autologous) bone marrow mesenchymal stem cells for~     treatment of spinal cord injury. This will include determination of functional recovery~     (neuro-muscular control and sensation) in the affected area and overall improvement in~     quality of life of the patients and also take into account any side effects, if observed.~   "
82875|NCT02482181|"~     The purpose of this study, is to investigate the value of diffusion weighted imaging on the~     differential diagnosis of solitary pulmonary lesions.~   "
82876|NCT02482168|"~     This study is a phase 1 open-label dose escalation study of the immuno-activating monoclonal~     antibody APX005M in adults with solid tumors. Study is intended to establish the maximum~     tolerated dose and the overall safety and tolerability of APX005M in 3 different~     administration schedules.~   "
82877|NCT02482155|"~     The main purpose of this study was to evaluate the pharmacokinetic (PK) profile of ibuprofen~     after oral administration of a single dose of MOMENT ACT ANALGESIC granules to healthy male~     and female subjects, under fasting conditions.~   "
82878|NCT02482142|"~     The study aim at:~      Investigating the impact of phosphorus ingestion on DIT of lean and obese subjects consuming~     high carbohydrate meal.~      Investigating the impact of phosphorus ingestion on DIT of lean and obese subjects consuming~     high protein-low phosphorus meal.~   "
82879|NCT02482129|"~     The purpose of the study is to determine whether topical ocular administration of LME636 60~     mg/mL is efficacious in resolving the ocular inflammation in the anterior chamber (AC)~     associated with acute anterior uveitis (AAU).~   "
82880|NCT02482116|"~     This research investigates the diagnostic accuracy of various diagnostic approaches for~     malaria and pneumonia in under-five children presenting to primary healthcare centres in~     Benin City, Nigeria.~   "
82881|NCT02482103|"~     This study is a national registry of patients treated with renal denervation (RD) in the~     Netherlands.~      The aim of the study is to collect data on safety of the procedure, predictors of the blood~     pressure lowering effect, sustainability of the effect and to assess the cardiovascular event~     rate in patients treated with renal denervation.~      This is a prospective observational study.~   "
82882|NCT02482090|"~     Adoptive T cell therapy with tumor infiltrating lymphocytes (TIL) has achieved impressive~     clinical results with durable complete responses in patients with metastatic melanoma. The~     TILs are isolated from patients own tumor tissue followed by in vitro expansion and~     activation for around 4-6 weeks. Before TIL infusion the patients receive 1 week of~     preconditioning chemotherapy with cyclophosphamide and fludarabine. After TIL infusion~     Interleukin-2 is administered to support T cell acitivation and proliferation in vivo.~      Recent studies suggest, that TIL therapy works in other cancers than Metastatic Melanoma,~     including Ovarian Cancer. In this study TIL therapy is administered to patients with~     metastatic Ovarian Cancer.~   "
82883|NCT02482077|"~     The purpose of this study is to assess the safety, tolerability, and efficacy of Sofosbuvir~     containing regimens in treatment-naive or treatment-experienced patients with HCV genotypes 2~     infection.~   "
82884|NCT02482064|"~     Ten patients who had had maxillectomy will be assigned to two groups employing two types of~     'temporary obturators. The obturators in the first group will be made from heat cure acrylic~     resin, whereas those in the second group from flexible resin.~      A comparison will be made between the two materials in terms of oral-nasal seal using the~     drinking water test as well as the mirror test.~   "
82885|NCT02482051|"~     The purpose of this study is to develop a new and very rapid diagnostic test for identifying~     a certain type of bacteria called Enterobacteriaceae in blood. Rapid identification of~     bacteria will assist in decreasing the use of antibiotics and help more patients survive~     bacterial infections of the blood.~   "
82886|NCT02482038|"~     This study is designed to look at the effect of the geko device on the circulation in lower~     limbs of participants with venous leg ulcers.~   "
82920|NCT02481596|"~     This study evaluates a family-focused mobile phone-delivered intervention, called FAMS~     (Family-focused Add-on for Motivating Self-care), in supporting adults with type 2 diabetes~     in their self-management relative to a control group. The goal of this study is to ascertain~     if family-focused content delivered to the patient can improve the patients' family support~     for diabetes self-care, self-efficacy, and adherence to diet and exercise recommendations.~   "
82921|NCT02481583|"~     The aim of this study was to characterise the pharmacokinetic properties and assess the~     safety of different formulations of levosulpiride in healthy Chinese volunteers.~   "
82887|NCT02482025|"~     Medication discrepancies, defined as unintentional differences found between patients'~     medical records and patients' reports of the medication they are taking, occur frequently~     after hospital discharge, predisposing to adverse drug events (ADEs), emergency department~     visits and readmissions. Resolving medication discrepancies - medication reconciliation - is~     mandated at every care transition, but little is known about intervention strategies to~     improve medication reconciliation in the post-discharge period, when patients may lack prompt~     access to primary care and are at high risk for ADEs. To address this gap, the investigators~     developed and pilot tested the Secure Messaging for Medication Reconciliation Tool (SMMRT),~     with a pharmacist communicating with Veterans to review medications and reconcile~     discrepancies after hospital discharge via Secure Messaging (SM), within My HealtheVet (MHV),~     VA's patient portal. The objectives of The SMMRT Trial are therefore~      To optimize the end-users' experience with SMMRT through usability testing and refinement of~     the tool; To conduct a randomized controlled trial (RCT) of usual care vs. usual care plus~     MHV Training vs. usual care plus MHV Training plus SMMRT to reduce hospital utilization; To~     evaluate how Veterans and staff perceived the impact of SMMRT on routine clinical practices~     and, specifically, on Veterans' interactions with their primary care providers.~   "
82888|NCT02482012|"~     Infants comprise a potentially vulnerable research population that received special~     consideration and protections under the US Code of Federal Regulations - Subpart D. Of the~     four categories of research involving children, 45 CFR 46.406 is of particular interest to~     researchers, ethicists, parents, and clinical staff members since it concerns the conduct of~     research with more than minimal risk without the prospect of direct benefit. Parents are~     the surrogate decision makers for infants. When asked about this type of research in studies~     pertaining to older infants and children, parent themes include: concerns of medical research~     and research-related risk, desire to advance generalizable medical knowledge and knowledge~     specific to their own child's disease. There are no data on parents' perceptions regarding~     this category of research that target the premature, late-preterm and term newborn~     populations.~      This study involves a questionnaire for both staff (nurses and physicians) and parents. The~     questionnaire represented 4 different infant scenarios in a random order. Respondents are~     asked to answer questions related to enrollment in a research study for each of the 4~     scenarios.~   "
82889|NCT02481999|"~     Evaluation of mechanisms and factors of anaesthesia on postoperative delirium and emergence~     agitation as well as on postoperative cognitive function in children aged 0,5-8 years~     scheduled for elective surgery. The depth of anesthesia in children for elective surgery aged~     0,5-6 years is monitored with intraoperative Narcotrend-Compact-M-Monitoring.~     Postoperatively the Pediatric Anesthesia Emergence Delirium Scores (PAED Score) [Sikich et~     al. 2004;Locatelli et al. 2013] is used to screen for the frequency of postoperative delirium~     in the post anesthesia care unit discharge of the child after surgery. Cognitive testings are~     performed in children of the study group (n= 470) and a control group (n= 80) with the~     parents support to evaluate deficits in children in their cognitive areas (POCD~     (Postoperative cognitive deficit)) at three different time points up to three months.~   "
82890|NCT02481986|"~     The Asthma Action at Erie Trial compares the current best practice in asthma self-management~     education (certified asthma educator services) to an integrated community health worker (CHW)~     home intervention in which the real-life challenges of patients and the health care system~     are taken fully into account. This trial will provide clarity as to the expected effect size,~     cost savings, and resources needed to integrate asthma CHWs into clinical practice.~   "
82891|NCT02481973|"~     Premenstrual syndrome (PMS) is related to the changes in the levels of hormones predominately~     progesterone, oestrogen and prolactin, during the luteal phase of the menstrual cycle. Both~     physical and psychological symptoms may occur from at least day 14 of the menstruation cycle~     and cease by day 4 of menstruation. The symptoms may interfere with a female's daily~     activities and have a negative impact well-being. There are a number of conventional~     pharmacological drugs which are used in the treatment or alleviation of the symptoms of PMS,~     however the drugs may have side effects and may negatively interact with other medications.~     Research has shown that homoeopathy is beneficial in relieving or decreasing the severity of~     PMS, however finding the individualised homoeopathic remedy can be difficult. Grant Bentley~     developed a system that helps find the most suitable remedy for each individual case. The~     Grant Bentley Method (GBM) uses homoeopathic case taking, photographs of the facial features~     and repertorisation to determine the dominant miasmatic group of the patient. This aids in~     the selection of specific homoeopathic remedy. There has been no research to show the effect~     of the GBM on PMS.~      This study aims to determine the effect of individualised homoeopathic treatment using the~     GBM, on females with PMS by using case studies and a daily self-grading PMS chart.~   "
82892|NCT02481960|"~     A study to demonstrate safety, and feasibility for intraparenchymal injection of irinotecan~     hydrochloride drug-eluting beads in the treatment of recurrent high grade glioma (HGG).~   "
82893|NCT02481947|"~     The purpose of this study is to evaluate a daily dose of BLI400 Laxative for safety and~     efficacy versus lubiprostone in constipated adults.~   "
82894|NCT02481934|"~     The purpose of this study is to determine wether activated and expanded autologous Natural~     Killer cells (NKAEs) are effective in the treatment of patients with multiple myeloma on~     second or later relapse. NKAEs are used in combination with anti-myeloma drugs such as~     lenalidomide or bortezomib.~   "
82895|NCT02481921|"~     The primary goal of this proposal is to improve the quality of care and outcomes for patients~     discharged with heart failure using an innovative multidisciplinary group intervention~     approach. Heart failure is a complex chronic illness where comprehensive patient-centered~     care is difficult and resource intensive. One potential solution is to use shared medical~     appointments (SMA), where a multi-disciplinary team of providers with expertise in nutrition,~     nursing, behavior and medication management join to manage heart failure. The investigators~     will enroll patients from Providence, Cleveland and Phoenix VA Hospitals who were within 12~     weeks of discharge from a heart failure hospitalization and randomized them to receive SMA~     intervention or usual care. Results from this project are expected to add an innovative~     intervention that could improve outcomes important for both the patient and the VA: health~     status, hospitalizations, and mortality.~   "
82897|NCT02481895|"~     Between 40% and 60% bipolar patients experience neurocognitive impairment not only during~     acute mood episodes but also during remission periods. These rates are quite similar to those~     reported as regards to functional impairment. In fact, it is estimated that only one third of~     patients achieve full social and occupational recovery and get back to their premorbid~     levels. Moreover, neurocognitive deficits, together with other clinical and sociodemographic~     variables are thought to contribute to functional impairment for bipolar disorder, similarly~     to that found in schizophrenia. Little is published with regard to neurocognitive remediation~     in bipolar disorder. The first open label study on bipolar disorder was published in 2010~     with positive results. Recently, a multicenter randomized clinical trial coordinated showed~     efficacy of an innovative intervention at improving functioning and reducing disability of~     bipolar patients. There is a need of investigating novel and creative ways to work on~     cognitive deficits including new technologies in order to reduce costs and increasing~     benefits for patients. No study addressing computerized cognitive training in bipolar~     disorder has been developed so far. This project aims to test the efficacy of an~     e-neurocognitive module as an adjunct to functional remediation in bipolar patients.~   "
82898|NCT02481882|"~     This study will provide information on cortical haemodynamics in MS patients to address the~     discrepancies reported in previous literature, allowing further insight into the role of~     haemodynamics in the disease. It will also instruct us as to the most effective scanning~     protocols for future research. Developing a suitable protocol for studying perfusion~     longitudinally may also enable identification of new therapeutic interventions to normalise~     any perfusion abnormalities in MS patients.~   "
82899|NCT02481869|"~     Patients who sustain broken ankles have a very high risk of developing arthritis soon after~     injury (within 2 years). This arthritis can cause increased pain and a decrease level of~     function, especially if the injury occurs at an early age. During and shortly after ankle~     injury, there is an inflammatory chemical process that takes place in the ankle that can~     cause damage to the cartilage in the ankle joint. The investigators want to use what is~     called Platelet Rich Plasma (PRP), which is produced from a small amount of the patient's own~     blood, to inject into the injured ankle to see if they can decrease the inflammation that~     happens after the injury and to see if they can decrease arthritis.~   "
82900|NCT02481856|"~     The trial is a phase II, randomised, parallel-group, double-blind, placebo-controlled~     multi-site trial conducted in Canada. Before the start of treatment, the subjects will~     undergo baseline birch and oak Environmental Exposure Chamber sessions. The treatment~     duration is 24 weeks. The subjects will undergo birch Environmental Exposure Chamber sessions~     after 8, 16 and 24 weeks of treatment and an oak Environmental Exposure Chamber session after~     24 weeks of treatment.~   "
82901|NCT02481843|"~     Prospective observational study in 40 adult critically ill patients. Patients were eligible~     if they were mechanically ventilated with an FiO2 ≤0.5 and PaO2/FiO2 ≥200 mmHg and~     hemodynamically stable with a hemoglobin ≥9 g/dL, no acute bleeding or need for blood~     transfusions, no renal failure, no chronic obstructive pulmonary disease. Twenty patients~     (hyperoxia group) underwent a 2-hour exposure to normobaric hyperoxia (FiO2 1.0), 20 patients~     were evaluated as controls. Serum erythropoietin (EPO) was measured at baseline, 24h and 48h.~     Serum Glutathione (GSH) and reacting oxygen species (ROS) were assessed at baseline (t0),~     after 2 hours of hyperoxia (t1) and 2 hours after the return to baseline FiO2 (t2).~     Sidestream dark field videomicroscopy was applied sublingually to assess the microvascular~     response to hyperoxia. Near infrared spectroscopy with a vascular occlusion test was applied~     at t0, t1, t2.~   "
82902|NCT02481830|"~     The purpose of this study is to compare the overall survival of nivolumab versus chemotherapy~     in subjects with relapsed SCLC.~   "
82903|NCT02481817|"~     The study is aimed at answering the questions; (1) How well do the most commonly used~     treatments in iSGS work? and (2) What quality-of-life trade-offs are associated with each~     approach?~      With the results of this trial, the investigators hope to provide information to iSGS~     patients: (1) Given my personal characteristics, conditions, and preferences, what should I~     expect will happen to me? and (2) What are my options, and what are the potential benefits~     and harms of these options?~   "
82904|NCT02481804|"~     This study aims to investigate if optimal personalized consultation by a dietician for a~     healthy diet focused on food which contains sufficient vitamins and minerals improves~     gastrointestinal symptoms as determined by an improved score in the gastrointestinal symptoms~     of the NET specific EORTC QLQ-GINET21 at end of study.~   "
82905|NCT02481791|"~     What is the optimal maintenance dose of remifentanil to ensure apnoea, during breath hold~     episodes in children having cardiac MR imaging with general anaesthesia?~   "
82906|NCT02481778|"~     Rationale:~      Radiation induced cardiac toxicity after treatment for intrathoracic tumours is a clinically~     relevant problem. So far, no clinical prediction models exist for cardiac toxicity. In~     particular, the relationship between radiation dose parameters and the risk of cardiac~     toxicity remains to be determined.~      Clinical prediction models for cardiac toxicity are difficult to obtain, e.g. due to long~     latency time. Therefore, objective surrogate markers, for cardiac toxicity such as NT pro BNP~     and hs-TNT, as obtained during and after treatment may be of great value.~      Objective:~      The main objective to find a correlation between the rise in NT pro BNP level and the~     radiation dose given to the heart.~   "
82907|NCT02481765|"~     Transcranial direct current stimulation (tDCS) is a method which enables noninvasive~     electrical stimulation of the cortex via electrodes placed on the subject's skull. High~     definition tDCS (HD-tDCS) allows for precise generation of electrical fields over selected~     cortical areas using multiple electrodes. The purpose of this pilot trial is to study~     feasibility, tolerability, and safety of HD-tDCS administered daily for a total of 20~     sessions in healthy adults and adults with Down syndrome.~      PRIMARY OBJECTIVES Part I: To assess feasibility and tolerability of HD-tDCS, administered up~     to 5 days per week for a total of 20 sessions in healthy adult subjects; Part II: After~     review of the safety data for Part I is completed and reviewed by the Data Safety Monitoring~     Committee and IRB, Part II will be initiated. To assess feasibility and tolerability of~     HD-tDCS, administered up to 5 days per week for a total of 20 sessions in adult subjects with~     Down Syndrome.~   "
84432|NCT02461875|"~     The aim of study is to compare the efficacy of GnRH antagonist rescue combined with~     cabergoline with cabergoline in the prevention of ovarian hyperstimulation syndrome in high~     risk patients undergoing ovarian stimulation for IVF-ET with long GnRH agonist protocol.~   "
82908|NCT02481752|"~     The purpose of this research study is to investigate the effect of a brief computer task~     (Approach Avoidance Task) on smoking cessation. The investigators will use a novel training~     protocol that works to target automatic thoughts and tendencies that occur outside of~     conscious control. Previous research suggests that these automatic tendencies may have a~     direct effect on certain health behaviors- like continuing to smoke despite having previous~     quit attempts.~      The investigators hypothesize that individuals in the AAT training condition will evidence a~     greater decrease in reaction times to avoid smoking-related stimuli & approach positive~     stimuli relative to those in the control condition. The investigators also expect that~     individuals in the AAT condition will exhibit superior outcomes on several quit-related~     variables as evidenced by an increase in motivation to quit smoking, an increase in number of~     days abstinent following a self-guided quit attempt, an increase in self-efficacy, and a~     decrease in urge to smoke compared to those in the SHAM training condition.~   "
82909|NCT02481739|"~     The aim of the investigators study is to know the results of the endometriosis surgery and~     particularly to highlight a benefit of this surgery on fertility.~   "
82910|NCT02481726|"~     Comparison of 68Ga-AlfatideII and 18F-FDG in differential diagnosis effectiveness towards the~     solitary pulmonary nodules of lung cancer or tuberculosis.~   "
82911|NCT02481713|"~     Purpose of study is to evaluate impact of brief motivational interviewing vs. feedback on~     learning styles in improving attendance to cognitive training~   "
82912|NCT02481700|"~     The aim of this study is to get a clear view on current practice of surgical third molar~     removal in Belgium and the association with morbidity and complications.~      For this prospective cohort study, patients who visit the outpatient department of Oral and~     Maxillofacial Surgery of the University Hospitals Leuven or hospitals affiliated with the~     Flemish Hospital Network will be participating. All included patients are referred from~     primary dental providers for the surgical removal of one or more third molars. Before~     participating, written informed consent will be recorded from all eligible subjects.~      Patients consult one of the oral and maxillofacial surgeons or residents working on the~     department of the University Hospitals Leuven for the removal of third molars. In the~     standard procedure, patients are not routinely clinically monitored after one week at the~     department.~      Pre-operative, operative and postoperative data will be collected through a questionnaire,~     extracted data from the patient's medical file and panoramic radiography. The surgeon's~     individual operation technique will be registered through a one-off questionnaire. The~     questionnaires are taken at the same time of consultation and includes a maximum of 8~     questions per time and are considered as non-invasive and a minimal burden for the patient.~     Postoperatively, patients record their recovery status and ability to resume daily- and work~     activities at day 3 and 7 by using a dairy system and, if necessary, revisit the outpatient~     department of oral and maxillofacial surgery.~   "
82913|NCT02481687|"~     Recently, Confocal Laser Endomicroscopy (CLE) has been developed as a novel technique that~     actually enables in vivo microscopic analysis of the gastrointestinal tract, during ongoing~     endoscopy. The potential role of CLE has been explored in pathology of both upper and lower~     gastrointestinal tract, showing good accuracy for predicting the final histopathological~     diagnosis, based on immediate evaluation of tissue and vascular patterns. Because of its~     minute scanning area, this techology is best used in conjunction with other red-flag~     techniques to screen the mucosa for areas of interest, which can then be examined by CLE for~     a histological diagnosis. I-scan technology (Pentax, Tokyo, Japan) is a new image-enhanced~     endoscopic technique that can achieve a virtual chromoendoscopy, but until now there have~     been no studies to determine the role of this technology in the evaluation of activity in~     inflammatory bowel disease. The study protocol is based on comparing imaging findings of~     p-CLE in conjunction with I-scan endoscopy with activity score and histological diagnosis of~     inflammatory bowel disease. CLE might have an important role in IBD patients management, by~     assessing the inflammation, dysplasia or response to treatment.~   "
82914|NCT02481674|"~     The purpose of this study is to evaluate the safety, tolerability, PK, and efficacy of~     VX15/2503 in subjects with late prodromal and early manifest Huntington's disease.~   "
82915|NCT02481661|"~     Anatomic segmentectomy may be a less invasive type of surgery than lobectomy for cT1aN0M0~     peripheral NSCLC and may retain more pulmonary function. It is not yet known whether anatomic~     segmentectomy is non-inferior to lobectomy in treating stage IA non-small cell lung cancer.~     The aim of this study is to investigate whether the outcome of anatomic segmentectomy is~     similar to lobectomy for peripheral stage IA (≤ 2cm)non-small cell lung cancer (NSCLC).~   "
82916|NCT02481648|"~     The investigators aim to evaluate the feasibility of a larger clinical trial assessing an~     exercise program during the teachable moment in patients with prostate cancer and measuring~     its effect on tumor apoptosis signaling, lipogenesis and steroidogenesis. Participants will~     be randomized between a 4-12 week exercise program or to standard of care only. Participants~     will be assessed at screening, baseline (day 0), throughout the trial intervention (days~     1-84), post-intervention visit (prior to radical prostatectomy) and final study visit~     6-months post-radical prostatectomy. At each assessment, physical, biological samples and~     psychosocial assessments will take place.~   "
82917|NCT02481635|"~     This is a phase 1 (the first phase in testing a new drug, to see how safe a new drug or new~     indication/population ) and phase 2 (the second phase in testing a new drug or new~     indication/population to see how effective the drug is) study of neoadjuvant (treatment~     before the main treatment) with gemcitabine and nab-paclitaxel (abraxane) and gemcitabine and~     radiation therapy before surgery and then gemcitabine and nab-paclitaxel after surgery in~     patients with pancreatic cancer that has grown to involve one of the major artery branches.~   "
82918|NCT02481622|"~     This non-interventional study aims to characterize the cells infected with HIV over time in~     different types of vagino-uterine tissue.~   "
82919|NCT02481609|"~     The purpose of this research study is to evaluate the use of NAC in the treatment of anosmia~     (a loss of the sense of smell). This drug is already approved by the Food and Drug~     Administration (FDA) for oral or pulmonary (lung) inhaled use for other medical conditions.~     However, there is research evidence that the medication may promote nerve recovery (help~     nerves work better after they are damaged). Since anosmia involves nerve problems, we believe~     the nasal spray may help treat anosmia. The medication has been in use for many years for~     other conditions, without safety problems.~   "
82922|NCT02481570|"~     The standard anesthetic care plan for people having adolescent idiopathic scoliosis surgery~     will be accompanied by a pharmacokinetic simulation of the administered drugs to suggest~     opportunities to adjust drug doses to achieve tolerable pain control after surgery, avoid~     respiratory depression and allow patients to respond quickly either during intraoperative~     testing or at the conclusion of surgery.~   "
82923|NCT02481557|"~     This study will assess sensitivity during a dental prophylaxis with or without the use of a~     potassium oxalate salt solution.~   "
82924|NCT02481544|"~     Psychosocial factors, including positive affect, finding meaning in the event, and managing~     emotional distress, influence prognosis following a heart attack or myocardial infarction~     (MI). Gratitude, typically defined as a feeling or attitude in acknowledgment of a benefit~     that one has received or will receive, is associated with higher levels of well-being, and~     people who are more grateful experience less stress, are less depressed, have higher levels~     of control over their environment, and more positive ways of coping. The present project will~     examine the potential benefits of a gratitude intervention (i.e., 8 weeks of gratitude~     journaling) to increase positive health behaviors, psychological health, and physical~     functioning in post-MI patients as compared to journaling about memorable events as well as~     care as usual alone. The investigators will study psychological and physical functioning at~     baseline, following 8 weeks of gratitude journaling or care as usual, and at 4-month~     follow-up.~   "
82925|NCT02481531|"~     This clinical trial will evaluate the growth, tolerance, and iron status of infants who~     consume an investigational infant formula containing a nutrient-rich whey protein compared to~     a previously marketed infant formula.~   "
82926|NCT02481518|"~     The purpose of this study is to determine whether magnesium preloading reduce incident of~     cisplatin induced acute kidney injury in head and neck cancer who receiving low dose~     cisplatin (40 mg/m2 weekly for 7 weeks).~   "
82927|NCT02481505|"~     This study evaluate the effect of 3 doses of Chloroprocaine HCl 1% (30, 40 and 50 mg) for~     spinal anaesthesia in adult patients undergoing short duration elective surgery of the lower~     limb. Patients undergoing elective short-duration lower limb surgery will be randomised into~     3 treatment groups (15 patients per group) to receive one of the 3 single doses of~     Chloroprocaine HCl 1%, i.e. either D1, D2 or D3, via intrathecal injection.~   "
82928|NCT02481492|"~     This is a prospect, randomized control trial to evaluate merits between flip and no flip~     technique in Shang Ring children circumcision.~   "
82929|NCT02481479|"~     Diabetes is associated with a substantially increased risk of heart failure, which is~     associated with substantial morbidity and mortality. Despite the development of new~     therapeutic strategies to improve glycemic control, recent clinical data from the saxagliptin~     assessment of vascular outcomes recorded in patients with diabetes mellitus-thrombolysis in~     myocardial infarction (SAVOR-TIMI) 53 study observed an unexpected finding of an excess of~     adjudicated heart failure hospitalizations. This excess occurred in the setting of~     pre-existing heart failure (HF) hospitalization and in those with elevated biomarkers for~     heart failure such as N terminal pro Brain type natriuretic peptide (NT-pro BNP). A wealth of~     preclinical data did not suggest a mechanistic basis for an excess of heart failure events,~     however these preclinical studies primarily focused upon prevention based strategies as~     opposed to regression studies once established heart failure was present. This proposal seeks~     to understand if and how dipeptidyl peptidase-4 inhibitors (DPP4i,specifically saxagliptin)~     may influence the development of heart failure, by evaluating changes in cardiac structure~     and function using cardiac magnetic resonance imaging (MRI).~   "
82930|NCT02481466|"~     The purpose of this study is to determine whether a dietary portfolio of cholesterol-lowering~     foods (viscous fibres, soy protein, plant sterols and nuts) further enhanced by increased~     levels of monounsaturated fatty acids (MUFA) and low glycemic index foods; together with a~     structured exercise program reduce the progression of carotid and coronary atheromatous~     lesions, Low density lipoprotein-cholesterol (LDL-C), and blood pressure, while reducing the~     number of individuals requiring statins.~   "
82931|NCT02481453|"~     Sporadic Inclusion Body Myositis (IBM) is the most frequent inflammatory myopathy in patients~     over 50. It is a slowly progressive, but today untreatable (notably by classical~     immunosuppressants) disease.~      Rapamycin used in organ transplantation blocks the activity of T effector cells, preserves T~     regulatory cells and induces autophagy (protein degradation), all parameters impaired during~     IBM.~      RAPAMI is a prospective, randomised, controlled, double blind, monocentric, phase IIb trial~     evaluating rapamycine against placebo.~   "
82932|NCT02481440|"~     The purpose of this study is to evaluate the safety and efficacy of intrathecal~     administration of allogeneic umbilical cord derived mesenchymal stem cells to patients with~     spinal cord injury.~   "
82933|NCT02481427|"~     Unicondylar knee arthroplasty (UKA) can be used as the treatment of knee OA isolated to a~     single compartment instead of TKA. Both UKA and TKA have been used for decades as a treatment~     of knee OA. However, operative indications for TKA and UKA overlaps, but they are not~     similar. Therefore, the outcome or survivorship of these procedures cannot be compared~     directly.~      Some advantages of UKA over TKA have been reported, including faster recovery time, reduced~     perioperative morbidity and mortality, a subjective preference of feeling more normal knee,~     lower cost and improved return to work and sport. On the other side national arthroplasty~     registers consistently report around a threefold increase in crude cumulative revision rate~     at 8 to 10 years for UKA compared with TKA 7-10.~      The aim of this study is to compare functional, clinical, patient satisfaction, and implant~     survival results of cementless UKA with those of cemented TKA at 2 months, 1, 2, 5 and 10~     years after the procedure. The study design is a multicenter, double-blind and randomized~     trial of knee replacement patients. The primary outcome is the Oxford Knee Score (OKS) and~     Knee Injury and Osteoarthritis Outcome Score (KOOS) at 2 year.~   "
82974|NCT02480894|"~     This is a Phase 1, open-label, single sequence, two-way interaction study in healthy male and~     female subjects. For the effect of maraviroc on the pharmacokinetics (PK) of BMS-626529 (the~     active moiety of BMS-663068), there is no formal hypothesis to be statistically tested. The~     purpose of this assessment is to estimate the effect of maraviroc on the PK of BMS-626529~     when coadministered in healthy subjects. For the effect of BMS-663068 on the PK of maraviroc,~     the hypothesis to be statistically tested is that BMS-663068 will not have a clinically~     significant effect on the PK of maraviroc when coadministered in healthy subjects.~   "
82934|NCT02481414|"~     This is a Phase II study to evaluate the efficacy and safety of a human papilloma virus (HPV)~     therapeutic vaccine called PepCan (HPV 16 E6 peptides combined with Candida skin testing~     reagent called Candin®) in adult females over a 12 month time period. As the results from the~     Phase I trial demonstrated some efficacy against non-16 HPV types, Candin alone will also be~     tested. Therefore, there will be two treatment arms: (1) PepCan and (2) Candin. Subjects~     found to be eligible for vaccination will be randomized in a double-blinded fashion at a 1:1~     ratio. Each participant will be receiving injections four times with three weeks between~     injections. Clinical and virological responses will be assessed at 6 and 12 months. Safety~     will be assessed from the time of enrollment to 12 Month Visit. Immunological assessments~     will be made at 4 time points (prevaccination, after 2 injections, 6 month after 4 injections~     and 12 months after 4 vaccinations).~   "
82935|NCT02481401|"~     Two Intensive Life Style Intervention Programs in Related Caregivers of Preschool Children~      Substantial strides have been made in the treatment of acute cardiovascular conditions, such~     as myocardial infarction and stroke, however, the global burden of cardiovascular disease~     (CVD) continues to rise at an alarming rate. Furthermore, despite the abundant data~     demonstrating a greater burden of CVD in racial/ethnic minorities, and many specific~     interventions aimed at changing risk factor patterns or behaviors in racial/ethnic~     minorities, health disparities persist. In the present study, the investigators seek to~     evaluate the impact of a multifaceted and comprehensive lifestyle intervention coupled with~     atherosclerosis imaging on reducing cardiovascular risk among minority adults living in~     Harlem, New York. The investigators believe that holistic, multi-dimensional individual and~     peer-to-peer intensive lifestyle interventions involving parents/caregivers of preschool~     children will be effective in producing favorable change in their behaviors, which will be~     sustained over time. The primary hypothesis of the study is that aggressive lifestyle~     interventions will be more effective in improving healthy behaviors and biological correlates~     in at-risk adult parents and/or caregivers of preschool children in Harlem, NY. In aim 1, as~     an initial pilot study, the investigators will identify the contextual factors, facilitators~     and barriers that may impact the implementation of a lifestyle intervention program for~     adults in Harlem, using qualitative research methods. In aim 2, the investigators will~     determine the impact of two intensive lifestyle interventions on promoting and improving~     healthy behaviors and biological parameters to lower cardiovascular risk, the impact of the~     knowledge of presence of atherosclerosis on health behaviors and the impact of these~     lifestyle interventions on atherosclerosis among approximately 600 asymptomatic at-risk~     adults. Finally, in aim 3, the investigators will evaluate the sustainability of the impact~     of the two intensive lifestyle interventions on healthy behaviors and biological parameters~     12 months after the intervention program ends.~   "
82936|NCT02481388|"~     The investigators aimed to evaluate the effects of cardiomegaly associated with inspiratory~     muscle weakness on tricompartmental distribution of chest wall volumes, on the thickness of~     the right hemidiaphragm and on the contraction speed of the respiratory muscles. As method of~     the present research, a pilot cross-sectional study was conducted with fourteen (14) patients~     with heart failure, functional class II and III, clinically stable, with cardiomegaly. Two~     groups were formed: one group with inspiratory muscle weakness (WG) (maximal inspiratory~     pressure - MIP <70% predicted MIP) and a control group without weakness (CG). The pulmonary~     and respiratory muscle functions were assessed by spirometry and manometer, respectively.~     Before and after maximal exercise test, optoelectronic plethysmography was performed to~     evaluate the distribution of volumes, the kinematics and the contraction speed of chest wall~     muscles. The high-resolution ultrasonography was also used before and after the maximum test~     for obtaining diaphragmatic thickness~   "
82937|NCT02481375|"~     Globally, the most common cause of anemia is thought to be iron deficiency anemia (IDA). This~     was assumed to be the major cause of anemia in Cambodia, because Cambodian diets, which~     consist mainly of rice, lack iron-rich animal food sources. However, our findings from a~     previous study in Cambodia (a Canadian government funded study investigating multiple~     interventions to improve food and nutrition security) showed that IDA is almost non-existent~     and challenges this assumption. In a cross-sectional survey of 450 women from rural Cambodia,~     only 1.0% had Hb and ferritin levels indicative of IDA (Hb <120 g/L and ferritin <15 μg/L). A~     national survey conducted by UNICEF in 2014 found similarly low rates of IDA (Dr. Arnaud~     Laillou, UNICEF Cambodia). Further, other micronutrients known to be associated with anemia~     were also low (<3%) including folate and vitamins B12 and B6.~      In addition, 54% of the Prey Veng women had a genetic Hb disorder (e.g., α-thalassemias),~     which are inherited diseases that can result in a defective Hb structure and/or impair Hb~     production, either of which can reduce Hb concentration and increase the risk of anemia.~     Further, genetic Hb disorders cause ferritin and soluble transferrin receptor (sTfR)~     concentrations to increase, which reduce the diagnostic sensitivity of these biomarkers to~     identify IDA.~      In 2011, the Cambodian Ministry of Health (MOH) recommended weekly iron and folic acid (IFA)~     supplementation for all women of reproductive age, consistent with WHO guidelines. However,~     if iron deficiency is not a major cause of anemia, then at best supplementation is a waste of~     valuable resources and at worst could cause harm. Further, the justification for provision of~     multiple micronutrients among this population has not yet been proven, despite the push from~     some organizations such as the WHO. There is an urgent need to conduct a trial to clarify~     whether iron or other micronutrient deficiencies are a major cause of anemia in Cambodia.~      Research Objectives:~        1. To compare Hb concentration (g/L) after 12-weeks of supplementation in women to~          determine if iron significantly improves Hb concentration, compared to a placebo;~        2. To compare Hb concentration (g/L) across the four groups (multiple micronutrients with~          iron, multiple micronutrients without iron, iron alone, and placebo) after 12-weeks; and~        3. To determine which of the hematological indicators (ferritin, sTfR, reticulocyte count~          and hepcidin) have the strongest diagnostic ability to predict responsiveness to iron~          therapy after 12-weeks using receiver operating characteristic (ROC) analyses.~      Methods: A 2 x 2 factorial randomized controlled trial will be conducted over 12 weeks. A~     total of ~800 women (18-45 y) with mild or moderate anemia will be recruited and randomized~     to 1 of 4 groups: multiple micronutrients with iron, multiple micronutrients without iron,~     iron alone or placebo. Blood will be collected at baseline and at 1 and 12 weeks after the~     intervention and assessed for Hb, hematological biomarkers, inflammation and genetic Hb~     disorders. The investigators will use a general linear model to measure differences in Hb~     concentration across the four groups after the intervention. Receiver operating~     characteristic curves will be used to determine the diagnostic ability of the multiple~     hematological indicators to predict responsiveness to iron therapy.~   "
82938|NCT02481362|"~     This study will examine differences in habituation to foods high in sugar and fat content~     versus those that are not, in normal weight women.~   "
82939|NCT02481349|"~     Objectives:~      Our specific aims are to:~      Primary Aim:~      Examine the feasibility of a couple-based and a caregiver yoga program in glioma patients~     undergoing radiotherapy (RT) and their partners.~      Secondary Aims:~      Establish the initial efficacy of the yoga programs in patients and their partners regarding~     quality of life (QOL) outcomes (i.e., fatigue, sleep disturbance, depressive symptoms,~     overall QOL and health care utilization).~   "
82940|NCT02481336|"~     To study the risk prediction of chemotherapy-induced peripheral neuropathy (CIPN) by the~     clinical bioinformatics and genomic profile.~   "
82941|NCT02481323|"~     Phase II pilot randomised, factorial, short term dose escalation, open label, blinded~     intermediary endpoint trial, in two hospital centres in the UK, of tolerability and safety of~     cilostazol, isosorbide mononitrate, both or neither in patients with small vessel disease~     manifest as symptomatic small subcortical stroke.~   "
82942|NCT02481310|"~     The purpose of this study is to evaluate the effects, good and bad of a new drug called~     ixazomib (also called MLN9708), when it is given along with a common treatment combination,~     called Dose-Adjusted EPOCH-R (DA-EPOCH-R, for short). This is a type of study called a phase~     I/II trial. In the phase I part, the dose of the study drug (ixazomib) will be adjusted~     (either up or down) to find the maximum (highest) dose that does not cause excessive (too~     many) harmful side effects. In the phase II part, this dose of ixazomib will be given at the~     maximum safe dose found in phase I. In both phase I and II, DA-EPOCH-R will be adjusted~     between cycles depending on how blood cell levels are affected between cycles. Ixazomib is~     considered investigational because it is not approved by the U.S. Food and Drug~     Administration (FDA). DA-EPOCH-R is a combination chemotherapy treatment developed over the~     last 14-15 years, and each of the drugs in this regimen is FDA-approved and considered part~     of the standard of care.~   "
82943|NCT02481297|"~     The goal of this clinical research study is to learn if lirilumab in combination with~     rituximab can help to control either CLL or SLL. The safety of the drug combination will also~     be studied.~   "
82944|NCT02481284|"~     The purpose of this study was to perform a quantitative perfusion study of the undermined~     abdominal skin in deep inferior epigastric artery perforator flap breast reconstruction~     patients in order to obtain more knowledge on perfusion dynamics. Laser Doppler perfusion~     imaging (LDPI) was used to evaluate this.~      Microcirculatory changes were monitored in the abdominal skin of 20 consecutive patients.~     Measurements were taken and recorded within four standardized zones covering the skin between~     the xiphoid process and the upper incisional boundary of the flap (zone 1-4; cranial to~     caudal).~   "
82945|NCT02481271|"~     This study aims to test the effects of a Preoperative Relaxation intervention and an~     Intensified Surgery Patient Education on pre- and postoperative wellbeing and health in~     Patients Undergoing Cholecystectomy.~   "
82946|NCT02481258|"~     The primary objective of the current study is to determine whether Ataciguat (HMR1766) slows~     progression of valve calcification in patients with moderate calcific aortic valve stenosis.~     Secondary and tertiary objectives are to determine whether Ataciguat slows progression of~     aortic valve function, reduces systemic inflammation, and prevents left ventricular~     dysfunction in patients with moderate calcific aortic valve stenosis.~   "
82947|NCT02481245|"~     We propose to test the hypothesis that bezafibrate, a pan-PPAR agonist, may be effective and~     safe for bipolar depression with the following specific aims:~      Aim #1. Proof-of-Concept Safety and Tolerability Aim: To assess the safety and tolerability~     of bezafibrate added to anti-manic medication for bipolar depression, especially with regard~     to worsening manic symptoms and suicidal ideation.~      We will conduct a phase IIa, 8-week, open pilot trial of bezafibrate added to FDA-approved~     anti-manic medication in 30 participants with bipolar depression. We will monitor changes in~     manic symptoms (Young Mania Rating Scale), suicidal ideation, cognitive functioning~     specifically in attention and verbal memory, and treatment emergent adverse events (SAFTEE).~     We will also monitor changes in the Framingham Cardiovascular Risk Score.~      Aim #2. Preliminary Assessment of Efficacy: To assess the antidepressant efficacy of~     bezafibrate added to anti-manic medication for acute bipolar I major depressive episodes.~      Hypothesis: The bezafibrate group will have a statistically significant decrease in the~     Montgomery Asberg Rating Scale (MADRS) Scores over 8 weeks. The results of this proof-of~     concept phase IIa study will help us to plan a placebo-controlled randomized trial. In~     summary, we propose an 8-week, proof-of-concept open pilot trial of an adjunctive pan-PPAR~     agonist, bezafibrate, for 30 patients with an acute bipolar I major depressive episode. The~     study may have a profound impact on the development of a novel treatment consistent with the~     mitochondrial dysregulation hypothesis of bipolar disorder and, to the best of our knowledge,~     will be the first proof-of-concept trial to assess a pan-PPAR agonist for bipolar disorder.~   "
82948|NCT02481232|"~     Safety Evaluation of freeze-dried Group ACYW135 Meningococcal conjugate vaccine in healthy~     people above 2-months-old~   "
82949|NCT02481219|"~     This study is designed to determine the optimal bowel preparation regimen for PillCam® COLON~     2 Capsule Endoscopy System (CCE) procedures in average risk patients.~      Patients will be randomized to receive one of two bowel preparation regimens prior to PillCam~     CCE.~   "
82950|NCT02481206|"~     A multi-center, prospective, randomized controlled clinical trial with 1:1 assignment of~     treatment and control. This study will evaluate the impact of wearable cardioverter~     defibrillator use on sudden cardiac death in incident hemodialysis patients. The study will~     enroll up to 2,600 subjects. A maximum of 200 sites in the USA will be used for enrollment.~   "
82951|NCT02481193|"~     The purpose of this study is to investigate the effects of different doses of cisatracurium~     pretreatment on succinylcholine-induced fasciculations and postoperative myalgia.~   "
82952|NCT02481180|"~     The purpose of this study is to assess the MTD, Pharmacokinetics and preliminary efficacy of~     T0001 in Rheumatoid Arthritis.~   "
82953|NCT02481167|"~     The purpose of this study is to identify age-related changes in chinese meibomian glands that~     may be associated with meibomian gland dysfunction (MGD).~   "
82954|NCT02481154|"~     This study evaluates the safety, pharmacokinetics, pharmacodynamics and clinical activity of~     AG-881 in Gliomas, that harbor an IDH1 and/or IDH2 mutation.~   "
82955|NCT02481141|"~     The aim of this pilot study is to assess the safety and preliminary efficacy of 5-ALA - SFC~     at doses up to 200 mg per day in subjects with type II diabetes.~   "
82956|NCT02481128|"~     Sentinel node biopsy is a well established tool for axillary staging in early breast cancer.~     So far the impact of a preoperative lymph node scintigraphy is unclear. This study aims to~     clarify whether a preoperative lymphoscintigraphy is of additional benefit in a prospective~     randomized multicenter study design.~   "
82957|NCT02481115|"~     The investigators hypothesize that critical care trained registered nurses and physicians can~     perform measurements of cognitive impairment in critically ill pediatric patients in a~     reliable and valid manner. To test this hypothesis, the investigators will incorporate an~     instrument (psCAM-ICU) to assess both components of consciousness, arousal and content, in~     critically ill pediatric patients at least 6 months to children 5 years of age, both on and~     off mechanical ventilation, and compare these assessments to those of the reference standard.~   "
82958|NCT02481102|"~     The objective of the Registry is to provide post market clinical outcome and potential health~     economics data and confirm the continued safety of the EpiAccess system.~   "
82959|NCT02481089|"~     Warburg effect is an important feature of tumors,and genetic variation is one of the main~     factors of individual differences to radiotherapy treatment response for nasopharyngeal~     carcinoma(NPC). Through the previous work investigators found that the p53 codon72 (Pro/Arg)~     was related to the prognosis of NPC; Using the method of proteomics, investigators discovered~     glycolysis related gene such as PGK1, ALDOA，was associated with radiosensitivity.Thus,with~     all the previous work,investigators hypothesize that the key gene polymorphisms in glycolytic~     pathway, such as p53 , influence the glycolytic pathway,which leads to differences in~     radiosensitivity of NPC. This projects will include 600 cases of patients with NPC to detect~     common glycolytic key genes polymorphisms. Besides,investigators correlate these factors with~     their radiosensitivity and prognosis.Then, prediction model will be established, and~     validation of the prediction model will be done. Using enzyme-labeling instrument ，comet~     assay and clonogenic assay，cytological experiments will further investigate the influence of~     key gene polymorphisms on the glycolysis efficiency and mechanism of radiation~     sensitivity.Thus,investigators could provide theoretical basis of individualized treatment~     for NPC.~   "
82960|NCT02481076|"~     The aim of this project is to find out if compression treatment can lower the incidens of~     surgical wound complications, such as infection and wound rupture, in patients with ankle~     fractures. The compression regime consists of a two-layered compression stocking applied~     after surgery and a massage boot applied both before and after surgery.~      The largest part of the study is the clinical trial, with which we aim to prove the~     hypothesis:~      * That the compression regime reduces wound infections from 10-40% to 5% on patients with a~     broken ankle (Either one side of the ankle, two or three sides (including the posterior part~     of the ankle))~   "
82961|NCT02481063|"~     This study evaluates the changes in muscles and tendons in the lower limb after an~     intervention of fatigue during 3 consecutive days between trained or not healthy subjects.~     One of the 2 groups received training by eccentric overload previously.~   "
82962|NCT02481050|"~     This is a Phase 2, open-label, single arm, multicenter, 2-stage study of eribulin mesylate~     administered biweekly at 1.4 mg/m2 intravenously for the treatment of participants with~     HER2-negative metastatic breast cancer previously treated with 2 to 5 chemotherapy regimens.~   "
82963|NCT02481037|"~     At least half of children with asthma have poor disease control, which can result in~     complications requiring emergency treatment and hospitalization. As asthma is one of the most~     common reasons for children to visit emergency departments (ED) and be hospitalized, this~     disease places a heavy burden on the health care system and families. While there is strong~     evidence that timely treatment with preventative therapies can substantially improve asthma~     control, reduce sudden worsening of symptoms, and lower rates of ED visits and~     hospitalizations, a significant proportion of children do not receive these therapies.~      The purpose of this study is to improve the prescription and use of evidenced-based~     preventative therapies for children with asthma with the goal to significantly improve their~     disease control and quality of life, while reducing unnecessary ED visits and~     hospitalizations. The investigators will achieve this by: i) installing a primary care~     clinical pathway for managing childhood asthma into clinicians' electronic medical record~     (EMR) to facilitate the use of best-evidence by practitioners, and ii) training chronic~     disease management (CDM) health professionals to provide targeted and timely asthma education~     to parents and children with asthma. The investigators will test this pathway and education~     project in a representative sample of 22 Alberta primary care practices, using a pragmatic~     cluster controlled trial methodology.~   "
82964|NCT02481024|"~     Background:~      Medication adherence following acute coronary syndrome (ACS) is often sub-optimal. Poor~     adherence is associated with increased risk of rehospitalisation along with higher rates of~     morbidity and mortality. After a cardiac event, transitioning from hospital into primary care~     can be problematic if it is not organised or coordinated properly. Patients can often find~     themselves unprepared and lacking the necessary information for self-management of their~     disease. The impact of care transition on medication adherence has not been studied in ACS.~      Objectives:~      This study will explore how an ACS patients' journey from hospital into primary care affects~     medicines use. Further, to understand how medicine information is communicated and how this~     influences patient beliefs about medicines.~      Methods:~      This is an interview study with recently hospitalised ACS patients discussing medication~     beliefs, communication of medicine information and the challenges when transitioning from~     specialist to primary care. Patients will be recruited from Guy's and St Thomas' NHS~     Foundation Trust and telephone interviews will be scheduled 3-4 weeks post-discharge. An~     inductive thematic analysis will be used to identify, construct and analyse patterns in the~     data and to develop a framework analysis. Analysis will be an iterative process conducted in~     parallel with data collection to highlight when data saturation has been reached.~      Dissemination:~      The primary objective is to develop a pharmacist-led behaviour change intervention to improve~     rates of medication adherence following an ACS. The in-depth patient data collected in this~     current study will contribute to the design and development of the intervention.~     Understanding the research topic from the patients' perspective is a necessity when designing~     an intervention targeting behaviour change.~   "
82965|NCT02481011|"~     The true incidence and risks of intracranial hemorrhage (ICH) in patients on various~     antithrombotic treatments remain unknown. Here a nationwide study is conducted to investigate~     the risk for and incidence rates of ICH in users and non-users of various oral antithrombotic~     drugs in Norway between 2008 through 2014.~      Hopefully, this study will contribute to a more responsible prescription pattern of~     antithrombotic medications.~   "
82966|NCT02480998|"~     This study evaluates the safety, tolerability and immunogenicity of IL-YANG quadrivalent~     vaccine versus IL-YANG trivalent vaccine after a single intramuscular administration in~     healthy Korean males and females 19 to < 65 years of age.~   "
82967|NCT02480985|"~     Damage to the pituitary gland is a frequently overlooked but potentially important~     complication of traumatic brain injury (TBI). Disorders of the pituitary gland can cause~     dysfunction of the thyroid, adrenals, ovaries and testes. These disorders may occur~     immediately or several months after TBI, may delay recovery and may have a significant~     negative impact on quality of life. TBI is the leading cause of disability and major~     permanent functional impairment among adults under 45 years of age. Hormonal deficits may~     contribute to common symptoms experienced by TBI survivors such as fatigue, poor~     concentration, depression and low exercise capacity. However, the association between~     hormonal deficits and disability remains uncertain. The primary objective of this pilot study~     is to assess the feasibility of a larger study that will evaluate the impact of pituitary~     disorders on neurological disability and functional recovery. The results of this study will~     provide key findings in the impact of pituitary disorders following TBI, which is a mandatory~     step prior testing the effect of hormonal replacement therapy in this population in costly~     clinical trials. If no relationship between pituitary disorders and disability is observed,~     the investigators' findings will prevent unnecessary, time-consuming and costly hormonal~     screening and will discourage potentially harmful hormonal therapy.~   "
82968|NCT02480972|"~     The purpose of this study is to assess degree of hepatic fibrosis using multiparametric MRI~     for investigating difference between normal or early fibrosis and advanced fibrosis.~   "
82969|NCT02480959|"~     The purpose of this study is to determine whether medial patellofemoral ligament~     reconstruction results in superior functional outcomes compared to medial retinacular~     plication surgery in cases of recurrent patellar instability.~   "
82970|NCT02480946|"~     Rheumatoid arthritis (RA) affects 1 percent of the population worldwide and up to 40 percent~     of patients don't respond to current treatments. MBS2320, the drug being tested in this~     trial, represents a new approach to treating RA, with the potential not only to reduce levels~     of inflammation but to also directly inhibit bone damage.The aim of this study is to test the~     safety of MBS2320 in healthy volunteers, to find out how MBS2320 levels change in the blood~     with dose, and to test the safety and compatibility of giving MBS2320 to patients with RA in~     combination with an existing treatment, methotrexate.~   "
82971|NCT02480933|"~     The aim of this study is to define silent breast cancer prevalence in both sexes and will be~     held by biopsies performed in imaging suspicious areas of the breast (ecography and~     mammography) in cadavers without known breast cancer.~   "
82972|NCT02480920|"~     This study will compose a national database of drug adherence and investigate the factors~     that affect drug adherence in patients taking new oral anticoagulation therapy in Turkish~     Population.~   "
82973|NCT02480907|"~     The purpose of the Supporting Carers of Children and Adolescents with Eating Disorders in~     Austria (SUCCEAT) - study is to compare Workshop, Internet-based and Conventional Parental~     Support Groups for carers of chilren and adolescents between 10 and 18 years in a randomized~     controlled trial for the first time in Austria.~   "
82975|NCT02480881|"~     This is an open-label, single sequence, 4-cycle, 4-treatment, drug-drug interaction (DDI)~     study in healthy female subjects on oral contraceptives (OC). There is no formal research~     hypothesis to be statistically tested. It is expected that coadministration of BMS-663068~     with OC will not affect the pharmacokinetics (PK) of either ethinyl estradiol (EE) or~     norethindrone (NE).~   "
82977|NCT02480855|"~     A vital question for society in general and primary health care in particular is early~     identification of persons at risk of sickness absence due to work-related stress. Even though~     both the individual and society can gain a lot from the prevention of absence, not the least~     since return to work is costly once a person is sick-listed. There is, surprisingly enough,~     no established method to do this. This project is a randomized controlled study of people~     with mental disorders and physical complaints consulting primary care. The purpose is to~     evaluate if a systematic use of early identification of work-related stress, combined with~     feedback at consultation, at the primary health care centers can prevent sickness absence~     among employed women and men with common mental disorders and subjective physical health~     complaints.~   "
82978|NCT02480842|"~     Introduction: physical therapy is essential in preventing motor and functional complications~     after breast cancer surgery. However, there is no prospective randomized study of different~     physiotherapy approaches in patients undergoing breast cancer surgery with immediate~     reconstruction. Objectives: to evaluate two physical therapy protocols in patients after~     breast cancer surgery with immediate reconstruction. A group with shoulder exercises with~     limited range of motion (ROM) at 90 degrees up to a month after surgery and a group with~     limited ROM only up to 15 days after surgery. Specific objectives: to evaluate shoulder ROM~     and pain one week before the surgery on average, and 07, 15, 30, 60, 90 and 180 days after~     surgery; assess motor function one week before the surgery on average, and 30 and 90 days~     after surgery; evaluate dehiscence and seroma 07, 15, 30, 60 and 90 days after surgery;~     associate incidence of seroma and dehiscence with preoperative risk factors and compare all~     variables (shoulder ROM, pain, motor function, seroma and dehiscence) between the two groups.~     Methods: women with breast cancer, who will be submitted to breast surgery (radical or~     conservative), followed by immediate reconstruction: alloplastic (tissue expander or breast~     implant) or oncoplastic (breast reduction or contralateral symmetrization) will be included.~     Patients that will be submitted to bilateral oncology surgery, reconstruction with autologous~     tissue or breast surgery without reconstruction will not be included. Patients will be~     recruited just after surgery scheduling and will undergo preoperative evaluation. At this~     moment, preoperative analysis will be conducted with personal data and medical history.~     Patients will undergo new assessments 07, 15, 30, 60, 90 and 180 days after surgery. All~     patients will receive standard physiotherapy treatment for women undergoing breast~     reconstruction from Physical Therapy Sector. The protocol consists of early exercise, limited~     to 90° of shoulder ROM, starting the day after the surgery and repeated 7 days after surgery.~     After 15 days of surgery, the patients will be randomized into two treatment protocols. One~     group will start to perform exercises with free shoulder ROM. Patients will be told only to~     limit the movement if they feel pain. The other group will keep shoulder exercises limited to~     90° up to 30 days after surgery. At that moment (one month after surgery), they will also be~     allowed to move the shoulder with no restriction. The evaluation of the presence of~     dehiscence and seroma will occur by inspection and palpation. Shoulder ROM will be~     investigated through active goniometry of flexion, extension, adduction, abduction, internal~     rotation and external rotation. The pain will be assessed with the Verbal Numerical Scale~     from 0 to10 and upper limb function through the DASH (Disabilities of the Arm, Shoulder and~     Hand Questionnaire) questionnaire.~   "
82979|NCT02480829|"~     Two Phase Multicenter Study to Evaluate Safety and Efficacy of the Amphora OAB system for~     treatment of urgency and frequency with or without urge incontinence caused by an overactive~     bladder.~   "
82980|NCT02480816|"~     The effects of consuming a sodium-bicarbonated mineral water rich in bicarbonate, sodium,~     chloride, lithium and silicon are studied in humans. The aim of this assay was to determine~     whether the consumption of this water as part of the usual diet, reduces cardiometabolic risk~     factors in adult men and women.~   "
82981|NCT02480803|"~     Both Continuous intrajejunal Levodopa Infusion (CLI) and Deep Brain Stimulation (DBS) are~     accepted therapies for the treatment of advanced Parkinson's disease (PD). To date, no~     comparative studies have been executed. The INVEST study is an open label randomised~     controlled trial with cost-effectiveness as primary outcome. Secondary outcomes will be~     quality of life, neurological impairments, among others.~   "
82982|NCT02480790|"~     Objectives of the study are: To estimate the incidence of venous thromboembolism (VTE) in a~     cohort of women with suspected ovarian cancer and evaluate changes in the coagulation system~     in case of benign or malignant disease. The impact of changes in the coagulation system on~     disease prognosis will be evaluated.~   "
82983|NCT02480777|"~     The primary purpose of this research study is to determine the safety of injecting ones own~     Schwann cells as a supplement along with nerve autograft (eg sural nerve) a few weeks after a~     severe injury to the sciatic nerve has occurred.~   "
82984|NCT02480764|"~     The purpose of this study is to evaluate the antihypertensive effect of azilsartan medoxomil~     compared with valsartan in Chinese participants with essential hypertension.~   "
82985|NCT02480751|"~     The purpose of this study is to determine the recommended dose of the sustained-release form~     of BPS (TRK-100STP low dose or high dose) in Japanese patients with CRF (Primary glomerular~     disease/nephrosclerosis).~   "
82986|NCT02480738|"~     This study is to investigate the effectiveness of computerized cognitive training, and~     corresponding neural substrates through multimodal neuroimaging assessment, in the elderly~     with normal cognition, subjective cognitive impairment, and mild cognitive impairment.~   "
82987|NCT02480725|"~     The study hypothesis is that that the deleterious effect of prions on the brain may be~     mediated (at least partially) by activation of serine proteases involved in the coagulation~     system. If this is true, then measurement of the activity of the coagulation system may be a~     marker of disease onset (in at higher risk individuals such as E200K* carriers) and for~     disease progression or activity in affected individuals. In addition, modulation of the~     coagulation system activity may be a potential tool for therapeutic intervention.~      *E200K- E200K mutation (Glu to Lys substitution) in the prion protein gene~   "
82988|NCT02480712|"~     The primary objectives of this study are to evaluate the efficacy, safety and tolerability of~     treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in participants with chronic HCV~     infection who were coinfected with HIV-1.~   "
82989|NCT02480699|"~     Chronic kidney disease (CKD) is characterized by a irreversible decrease of kidney functions.~     It is characterized by accumulation of solutes called uremic toxins. Uremic toxins levels are~     implicated in cardiovascular complications associated with CKD. Several protein-bound toxins~     have been implicated in the increased cardiovascular risk such as indoxyl sulfate (IS), p~     cresol sulfate (pCS) and more recently the indole acetic acid (IAA). All clinical studies are~     performed with a single measurement at baseline assuming that the toxin levels are stable~     over time. The variability of uremic toxins level is not known. Furthermore, little is known~     concerning determinants of serum toxins level.~   "
82990|NCT02480686|"~     This study will evaluate the efficacy and safety of NEUTRINO regimen in Chinese chronic HCV~     genotype 1b treatment-experienced patients.~   "
82991|NCT02480673|"~     The objective of this study is to evaluate the effect of the administration of 25 g of chia~     per day, for 90 days on the biochemical components of the metabolic syndrome in subjects with~     this condition~   "
83109|NCT02479126|"~     The primary objective of this research project is to describe the characteristics, diagnosis,~     management, and outcomes of patients with Interstitial Lung Disease (ILD) who received care~     at the Veteran's Administration Veterans Integrated Service Network (VISN) 6 Mid-Atlantic~     Health Care Network (VISN6) (includes North Carolina, Virginia and West Virginia) for up to 5~     years.~   "
82992|NCT02480660|"~     Purpose: To understand the baseline knowledge on the transition of care to adult providers in~     hospitalized adolescent patients and to test if an educational intervention given during an~     inpatient stay in a medium size academic pediatric hospital affects perception of knowledge,~     attitudes and participation in transition planning.~      Primary Research Question: Will a video-based educational intervention in an academic~     pediatric hospital affect perception of knowledge, attitudes and participation in transition~     planning to adult oriented health care of the hospitalized adolescent?~      Secondary Research Question: What is the baseline experience of the hospitalized adolescent~     in key elements of transitioning to adult oriented health care?~   "
82993|NCT02480647|"~     Randomized clinical trial the use of levonorgestrel releasing intrauterine system.~      Objectives: To evaluate and compare the efficacy of- levonorgestrel releasing intrauterine~     system l(LNG-IUS) in relation to the subdermal implant releasing etonogestrel (ENG) in the~     control of chronic pelvic pain and / or dysmenorrhea in women endometriosis.~   "
82994|NCT02480634|"~     This study will give comparison of the bone pain remission and the adverse reaction of~     Zoledronic acid combine with High dose fractionation radiotherapy(30Gy/10f) and Zoledronic~     acid combine with low dose fractionation radiotherapy(15Gy/5f) . The purpose of this trial is~     to prove whether Zoledronic acid combine radiotherapy can reduce radiotherapy dose in~     treatment of non-small cell lung cancer bone metastasis'pain relief or not.~   "
82995|NCT02480621|"~     This study is a randomized controlled trial assessing pain control in ankle fractures~     repaired with open reduction and internal fixation. Patients are consented and enrolled~     pre-operatively, and randomized to either control or liposomal bupivacaine with bupivacaine~     administered intra-operatively.~   "
82996|NCT02480608|"~     The study will test the tolerability and efficacy of the combination therapy~     Imatinib/Hydroxyurea (HU) in patients with chronic myeloid leukemia (CML) in first chronic~     phase (CP1) newly diagnosted or failing interferon-based therapy.~   "
82997|NCT02480595|"~     The ARCHYTAS Registry is a long-term, global, multicenter, non-randomized, prospective,~     registry designed to collect on-label data in real world clinical settings on patients~     undergoing endovascular repair with the latest generation Aorfix™ AAA Flexible Stent Graft~     System. Registry data will augment existing data from ongoing and prospective Aorfix™~     clinical trials for the purposes of publication, general product development and quality~     measures.~   "
82998|NCT02480582|"~     The current study will examine the effect of almond consumption (0.9g/kg dose) compared to an~     energy and weight matched comparator food or no food on measures of appetite control~     including appetite sensations, energy intake and food hedonics.~   "
82999|NCT02480569|"~     The investigators propose a single center prospective study that will assess two different~     strategies for measuring Fractional Flow Reserve (FFR) in patients undergoing~     clinically-indicated coronary angiography in whom FFR measurement is indicated. FFR will be~     measured with a non-side hole guide catheter (with the guide catheter both engaged and~     disengaged from the coronary ostium) and with a side-hole guide catheter (with the guide~     catheter both engaged and disengaged from the coronary ostium) to determine, whether~     measurements obtained with an engaged side-hole guide catheter are more accurate as compared~     with those obtained with the engaged non-side hole catheter.~   "
83000|NCT02480556|"~     to compare the blood loss during caesarean section between two different methods of~     separating the placenta after fetal extraction, keeping in mind that most blood loss occurs~     after placental separation.~   "
83001|NCT02480543|"~     A randomized clinical trial to assess the effectiveness of same-day cervical preparation with~     oral, buccal or vaginal Misoprostol, given 2-4 hours prior first trimester curettage.~   "
83002|NCT02480530|"~     The purpose of this research study is to improve statin medication adherence among Veterans~     with coronary artery disease with poor adherence to medications. The investigators are~     testing if newer technology pill bottle devices linked with individual feedback and/or social~     incentive strategies can improve medication taking behavior.~   "
83003|NCT02480517|"~     The Wave VI study is a, multicenter, prospective, double-blind, randomized, sham controlled~     feasibility study of the safety of renal denervation in patients with stage I and II~     hypertension who have an average office systolic blood pressure between 150 and 180 mmHg and~     have not been on any antihypertensive medications for at least six months.~   "
83004|NCT02480504|"~     A randomized clinical trial comparing the effect on weight reduction and cardiometabolic risk~     factors of intermittent energy restriction and a isocaloric continuous energy restriction in~     obese subjects.~   "
83005|NCT02480491|"~     Study of Cell Free DNA Content of Human Embryo Culture Medium as a Non-Invasive Tool for~     Embryo Assessment in intra cytoplasmic sperm injection Treatment Cycles.~   "
83006|NCT02480478|"~     Intrahepatic cholestasis of pregnancy is the most common liver disease in pregnancy. It is is~     a pregnancy-specific liver disorder with onset mainly in the third trimester of pregnancy.~     ICP is characterized by pruritus, elevated serum fasting bile salts and transaminases and an~     increased risk of adverse fetal outcomes. Serum autotaxin levels were found highly sensitive~     and specific biomarker to to differentiate ICP from other pregnancy-related liver disorders~     or pruritic dermatoses. The purpose of the study is to determine the diagnostic accuracy of~     serum autotaxin activity in cholestasis of pregnancy.~   "
83007|NCT02480465|"~     Efficacy and Safety of Lobeglitazone versus Sitagliptin in inadequately controlled by~     Metformin alone Type 2 Diabetes mellitus Patients with Metabolic syndrome.~   "
83037|NCT02480062|"~     Major barriers to controlling cardiovascular diseases (CVDs) in India and elsewhere are: low~     detection rates, inadequate use of evidence based interventions and low adherence with these~     interventions. Primary health care is the appropriate setting for improving the prevention~     and management of these chronic conditions. The investigators will develop and evaluate an~     innovative mobile health (mHealth) software application -'m-WELLCARE'- which provides a~     patient health profile, decision support for clinical care, monitoring and feedback for use~     in Indian Community Health Centers (CHCs). The investigators will conduct this research~     following the steps proposed by the medical research council (MRC) for evaluation of complex~     interventions. Technical development of m-WELLCARE will be conducted, user acceptability~     appraised and potential barriers overcome. m-WELLCARE will be evaluated in CHCs of two~     states, Haryana and Karnataka. The use made of m-WELLCARE, its impact on patterns of health~     care received and changes in risk factors achieved will be evaluated.~   "
83008|NCT02480452|"~     The overall goal of this research proposal is the early prediction of the emergence of CVI~     and its characteristics on the basis of neuroimaging data.~      The different steps that will be taken to achieve this goal will be:~        1. To characterize CVI deficits in children;~        2. To correlate the CVI characteristics with their motor profiles;~        3. To characterize brain lesions in children with CVI;~        4. To link the motor profile, CVI profile and brain metrics of the children.~      Over the last 10 years, 488 children with and without CP have consulted at the CVI clinic in~     Leuven. All these children had a comprehensive visual perceptual assessment, cognitive~     evaluation and an ophthalmological assessment. Summarizing these data results in a~     quantitative visual perceptual profile for each individual patient. The goal is to~     prospectively extend this database to a number of 600 children. The project's primary~     objective is to relate the presence of CVI to the motor profiles of these children.~      Of these 488 children, 300 have an MRI available. The goal is to analyze the retrospective~     MRI data of this clinical group and to prospectively extend this database by reassuring newly~     registered children will receive MRI with DTI. This will allow the investigation of the~     correlation between the brain metrics and the CVI characteristics in a large cohort.~   "
83009|NCT02480439|"~     The purpose of this study is to assess the relative bioavailability of a TAK-648 tablet~     compared with a TAK-648 oral solution, and to assess the effect of food on the~     bioavailability of a TAK-648 tablet in healthy participants.~   "
83010|NCT02480426|"~     To prospectively evaluate the efficacy of real-time 3D CT-image guidance and CO2 portography~     during transjugular intrahepatic portosystemic shunt (TIPS) creation.~   "
83011|NCT02480413|"~     The purpose of this prospective single center study is to investigate if a developed~     algorithm is more accurate than the pediatric emergency tape (Alpha 1 Werbedesign e.K.,~     Falkenberg, Germany). For this study 500 patients are required to collect anonymized data~     (length, weight, age, anaesthesia material used during anaesthesia) for achieving a power of~     80% during statistical analysis. The main hypothesis ist that the algorithm has a better~     accuracy than the pediatric emergency tape (53% are in a +/- 10% interval).~   "
83012|NCT02480400|"~     To evaluate the effect of visit number, patient expectation, and rater expectation of the~     efficacy of escitalopram treatment in fixed doses of 10 and 20mg, based on baseline severity~     in patients with MDD.~   "
83013|NCT02480387|"~     Target Population: Hepatitis C Treatment Naïve, non-cirrhotic, Chronic genotype 1 hepatitis C~     virus (HCV) infected adults that are co-infected with human immunodeficiency virus (HIV)-1and~     have HCV RNA < 6 x106 IU/mL~      Duration of Subjects will be treated for 8 weeks and followed for 24 weeks post- Treatment:~     treatment~   "
83014|NCT02480374|"~     This dose escalation study will determine a maximum tolerated dose and/or optimal biological~     dose of GEN-1 for carboplatin/paclitaxel combination in newly diagnosed ovarian cancer.~   "
83015|NCT02480361|"~     Postoperative ileus (POI) is a common problem after major abdominal surgery. Acupuncture is~     being accepted in the West as a treatment option for managing POI and various functional~     gastrointestinal disorders. Therefore, we conducted a prospective randomized pilot study to~     evaluate the effect of electro-acupuncture on POI and other surgical outcomes in patients who~     underwent gastric surgery for a later large-scale study.~   "
83016|NCT02480348|"~     The purpose of this trial is to evaluate the clinical safety and efficacy of the Polymer-Free~     Drug-Eluting coronary stent system for the treatment of de novo lesions in native coronary~     arteries with a reference vessel diameter (RVD) that allows use of stents between 2.25 and~     3.50 mm in diameter.~   "
83017|NCT02480335|"~     The aim of the study is to investigate whether bosentan added to usual care improves arterial~     stiffness after 3 months as measured as the pulse wave velocity (PWV) of the medium and large~     arteries corrected for blood pressure changes in patients with systemic sclerosis (SSc) with~     digital ulcers (DU). Patients will be randomized into a group with usual care and bosentan~     (n=20) or usual care only (n=20). PWV will be assessed at baseline, 3 months and 12 months.~   "
83018|NCT02480322|"~     Background: Obesity is associated with multiple diseases. Bariatric surgery is the most~     effective therapy for severe obesity that cannot only reduce body weight but also~     obesity-associated morbidity.~      Objective: The metabolic alterations associated with obesity and respective changes after~     bariatric surgery are incompletely understood.~      Design: In the longitudinal observational study, the investigator applied a 1H-NMR-based~     global, untargeted metabolomics strategy on human serum samples that were collected before~     and repeatedly up to one year after distinct bariatric procedures (sleeve gastrectomy,~     proximal and distal Roux-en Y gastric bypass; RYGB). For comparison, the investigator also~     analyzed serum samples from normal-weight and less obesity obese subjects that were matched~     for 1-year postoperative BMI values of the surgical groups.~   "
83019|NCT02480296|"~     The purpose of this study is to establish safety, tolerability, pharmacokinetics and~     pharmacodynamics of multiple doses of MYK-461 in human subjects. This is a randomized,~     double-blind, placebo-controlled, sequential group, multiple ascending (oral tablet) dose~     study in healthy volunteers aged 18-55 years.~   "
83020|NCT02480283|"~     This study plans to evaluate the effects of chronic cannabis smoking on lung health by~     evaluating its effects on pulmonary health, lung physiology and alveolar macrophage function.~   "
83038|NCT02480049|"~     Comparative randomized, single dose, two-way crossover open-label study to determine the~     bioequivalence of Montelukast fromAsmakast10 mg tablets (Man. by Minapharm Egypt for Novartis~     Pharma Egypt S.A.E (Sandoz), Egypt) and Singulair10 mg tablets (Produced by Global Napi~     Pharmaceuticals, Egypt under license from: Merck & Co. Inc., USA) after a single oral dose~     administration of each to healthy adults under fasting conditions.~   "
83039|NCT02480036|"~     The primary objective is to evaluate the tolerability (side effects) of the intraoperative~     radio therapy (IORT) (e.g., wound healing, infections, bone necrosis, nerve, spinal cord~     damage, and pathological fracture), and the secondary objective is to evaluate the~     effectiveness of IORT (i.e., pain relief, quality of life, narcotic use, and tumor response).~   "
83040|NCT02480023|"~     BMD at peripheral sites typically heel is measured by Ultrasound densitometry at Ain Shams~     Maternity hospital.~   "
83744|NCT02470832|"~     The study is being conducted to investigate the effect of itraconazole treatment in the~     pharmacokinetics of RG1662. It is also to evaluate the exposure of RG1662 vs. QTc response~     relationship and the safety and tolerability of RG1662 when given in combination with~     itraconazole in healthy subjects.~   "
83021|NCT02480270|"~     This study plans to learn more about the effect of oral antibiotics for an outpatient~     pulmonary exacerbation (respiratory illness) on sputum (mucus) bacterial infections, lung~     function, airway inflammation and quality of life. In this study subjects will perform~     pulmonary function tests, provide a sputum sample and complete a questionnaire at two~     separate clinic visits. If a subject is unable to cough up sputum in clinic he or she will be~     asked to breathe in a salt water solution to help cough up sputum. The first sputum sample~     will be obtained at the first visit (within 48 hours of starting antibiotics). Pulmonary~     function testing and the questionnaire will also be completed at this time. Subjects will~     complete a two week course of oral antibiotics at home. During these two weeks subjects will~     be asked to write down the times antibiotics are taken and airway clearance (vest treatment)~     is performed. Within one week of completing the antibiotic course subjects will return to~     clinic for a second visit. At that time a sputum sample will be obtained again and if~     subjects are unable to cough up sputum they will again be asked to breathe in salt water~     solution to help cough up sputum. Pulmonary function testing and the questionnaire will also~     be completed at this second visit. Sputum samples will be tested for infections with bacteria~     and viruses. Sputum samples will also be used to measure markers of airway inflammation~     (swelling). The investigators hypothesize that the use of two weeks of oral antibiotics for~     the treatment of a pulmonary exacerbation will result in a decrease in the amount of bacteria~     measured in sputum. Additionally the investigators hypothesize that treatment with~     antibiotics will lead to an improvement in lung function, a decrease in airway inflammation~     and an improvement in quality of life measurements.~   "
83022|NCT02480257|"~     The investigators aim to refine and pilot test an innovative group treatment model for~     adolescent depression and anxiety, Training for Awareness, Resilience and Action (TARA) in a~     sample of 14-18 year olds with depressive or anxious symptoms.~   "
83023|NCT02480244|"~     This is a cluster randomized trial (CRT) to assess the effectiveness of a culturally~     appropriate behavioral intervention to reduce obesity levels and ultimately the risk of~     developing diabetes type II in immigrant Latino farm workers. Randomization is at the farm~     ranch level. Individuals at intervention ranches will receive a multi-week curriculum at the~     work-site on diabetes, diet and physical activity and optional supplemental sessions in the~     evening and weekends. The investigators will adopt the intent-to-treat principle for the~     primary analysis. Individuals on control ranches will receive no health educational~     instruction. The primary outcome is BMI. The investigators hypothesize that intervention~     ranches will achieve significant improvement in obesity and diabetes risk factors as compared~     to control ranches.~   "
83024|NCT02480231|"~     Prospective randomized clinical trial comparing two methods of intra-operative tensioning of~     retropubic midurethral slings for stress urinary incontinence. Primary outcome is rate of~     abnormal bladder function. Secondary outcomes include validated quality of life scores,~     physical exam findings, and rates of immediate post operative voiding dysfunction.~   "
83025|NCT02480218|"~     Breast cancer is the most frequently diagnosed cancer in women with the majority receiving an~     endocrine therapy (ET) in the adjuvant setting. ETs dramatically reduce recurrence and~     improve survival but given the aging population and increased survivorship, there are growing~     concerns regarding the cognitive effects of ETs since estrogen is neuroprotective. A critical~     unanswered question is whether there are differences in cognitive decline between the two~     classes of ETs, selective estrogen receptor modulators (SERMs - tamoxifen) and aromatase~     inhibitors (letrozole and anastrozole), in older women at greater risk of hormone receptor~     breast cancer and cognitive decline. Before a large multicentre observational study can be~     undertaken the investigators are proposing a feasibility study to establish metrics on~     participation, retention and adherence rates and parameter estimates to inform sample size~     calculation required to detect cognitive differences between the two ET classes. A~     convenience sample of chemotherapy-naïve patients, aged 65 and older, with early stage~     disease, 25 on a SERM and 50 on an aromatase inhibitor, will be assessed cognitively at~     baseline and after one year.~   "
83026|NCT02480205|"~     There is currently a consensus that non-invasive ventilation (NIV) in preterm infants is~     preferred over intubation. There are two ways of delivering NIV in preterm infants, nasal~     continuous positive airway pressure (CPAP) or nasal intermittent positive pressure~     ventilation (NIPPV), where ventilator inflations are delivered intermittently over a fixed~     end-expiratory pressure. The synchronization in conventional mode is very difficult to obtain~     in premature infants. In all ventilation modes PEEP (end-expiratory pressure) is fixed.~     Considering that preterm infants are more likely to develop atelectasis, an active and~     ongoing management of the PEEP is very important to prevent de-recruitment.~      A new respiratory support system (NeuroPAP) was developed to address these issues~     (synchronization problems and control the PEEP). It uses the electrical activity of the~     diaphragm (EDI) to control the ventilator assist continuously, both during inspiration~     (principle of NAVA mode) and also during expiration (based on tonic Edi level).~   "
83027|NCT02480192|"~     Women going through the menopausal transition often experience adverse physical changes~     (e.g., hot flashes/night sweats, sleep difficulties, sexual concerns) in addition to~     emotional difficulties (e.g., depression, anxiety) that can significantly impact functioning~     and overall quality of life. To date, hormone therapy (HT) has been the most commonly used~     treatment to relieve symptoms of menopause. However, reports have questioned the safety of HT~     long-term (e.g., risk of heart attacks, strokes, cancer) in some women. Cognitive-behavioural~     therapy (CBT), has been proposed as a low-risk treatment for menopausal symptoms and received~     some initial support. The investigators developed a comprehensive non-pharmacological, CBT~     based treatment program for menopausal symptoms, published the treatment manual, and have~     initial evidence supporting its effectiveness with the investigators' published pilot data.~     The investigators' goal is to conduct a large randomized controlled trial of Cognitive~     Behavioural Group Therapy (CBGT) for the improvement of menopausal symptoms. The~     investigators hypothesize that participants will experience fewer and less intense/disruptive~     hot flashes/night sweats, reduced depression and anxiety and improvement in sleep~     difficulties, sexual concerns, and overall quality of life. The investigators also predict~     that these benefits will be maintained at follow up and there will be high satisfaction~     associated with the program by participants.~   "
83745|NCT02470819|"~     The primary objective is to examine the impact on progression-free survival of targeted~     therapy for breast cancer suggested by proteomic and genomic profiling.~   "
83028|NCT02480179|"~     The investigators plan to evaluate H.E.G. (Hematoencephalography) modality in brain~     modulation of appetite and food craving in a randomized controlled study. The H.E.G. will~     serve as the neurofeedback modality while the functional brain imaging will enable assessment~     and hopefully validation of changes brain activity related to food craving and self-control.~     H.E.G. is a relatively new neurofeedback technique which similar to fMRI, is based on changes~     in blood oxygenation level as a result of regional brain activation. The unique advantage of~     this technology regarding our enterprise is that it inheritably samples the two brain areas~     that are in our focus of interest: the superior orbito-frontal cortex (OFC) which Involved in~     self-control and reward processing, and the anterior cingulate cortex (ACC) which processes~     cognitive and emotional information. The investigators will combine HRV (Heart rate~     variability) biofeedback, which is a well-established treatment form in the investigators~     therapeutic sessions and will correlate functional neuroimaging with behavioral,~     anthropometric and laboratory data.~      The intervention name is: Measurements of blood flow changes within the brain and online~     visual feedback to the participant by a H.E.R. (Hematoencephalography) N.I,R (Near Infra Red~     sensor) sensor made by MindMedia, The Netherlands and a NEXUX4 Hardware, Bluetooth unit, Bio~     Trace Plus software made by MindMedia, The Netherlands.~      Hypothesis: The neurofeedback practice sessions are expected to facilitate improved control~     of blood flow to frontal brain areas, as a marker of brain activity in these areas~   "
83029|NCT02480166|"~     The primary objectives of this study are to describe the efficacy of:~        1. 8-week treatment of SOF/LED for treatment-naïve, non-cirrhotic, HCV genotype 6~        2. 12-week treatment of SOF/LED for all other HCV-6 populations~   "
83030|NCT02480153|"~     The study will assess the efficacy, safety, and immunogenicity of PF-06410293 and adalimumab~     in combination with methotrexate in subjects with moderately to severly active rheumatoid~     arthritis who have had an inadequate response to methotrexate.~      In an additional optional portion of the study, during open label Treatment Period 3 (TP3), a~     subset of subjects used a Prefilled Pen (PFP) to administer up to 3 injections of their study~     treatment (PF-06410293) at home.~   "
83031|NCT02480140|"~     Emerging research suggests the use of self-regulation (SR) strategies at improving functional~     regain in patients with brain injury. SR is proposed to produce an added effect to the~     effective constraint-induced movement therapy (CIMT). This study aimed to examine the~     efficacy of a self-regulated CIMT program (SR-CIMT) for function regain of patients with~     subacute stroke. It was hypothesized that participants receiving the combined treatment (SR~     and CIMT) would have a better functional regain.~   "
83032|NCT02480127|"~     Repeated implantation failure (RIF) is determined when failure of implantation occurred~     during at least three consecutive IVF attempts while at least one high-grade embryo was~     transferred in each cycle. Several methods have been suggested to improve the implantation~     rate in RIF patients. One of the most promising methods is local injury to the endometrium.~     It has been reported that the rates of implantation, clinical pregnancy, and live birth reach~     more than double in RIF patients with local endometrial injury than patients without it. The~     population of this study included all infertile couples attending the Royan Institute, who~     have at least three consecutive cycles of ART failure. Also this study is phase 3 randomized~     clinical trial. Based on the average menstrual cycle 30-28 days, endometrial and blood~     samples were collected from two groups of patients on day 21 of luteal phase of their~     spontaneous menstrual cycle. The intervention, but not the control group underwent prior~     biopsy treatment in follicular phase on days 8 or/and 11 to 13 of that same cycle but in~     these days blood sample in both groups were collected. To investigate the impact of local~     endometrial injury in increasing the rate of pregnancy in ART - treated RIF patients, the~     investigators will examine the changes of immunological factors involved in the implantation~     including some cytokines, growth factors ( in serum and endometrial biopsies) and the~     expression of TLRs and HOX genes ( in endometrial biopsies) obtained from both groups.~   "
83033|NCT02480114|"~     This randomized phase III trial studies how well gabapentin plus standard of care work~     compares to standard of care without Gabapentin in preventing inflammation of the mucous~     membranes (mucositis) in patients with stage III-IV head and neck cancer that are undergoing~     primary or subsequent (adjuvant) chemoradiation therapy. Radiation therapy to the head and~     neck may cause a burn involving the inside of the mouth, throat, and nasal passages,~     resulting in pain. Gabapentin may help prevent (or minimize) pain associated with~     radiation-induced mucositis in patients with head and neck cancer.~   "
83034|NCT02480101|"~     This is a single centre phase I, double-blind placebo-controlled study to assess~     reactogenicity, safety and immunogenicity of a live monovalent A/17/Anhui/2013/61 (H7N9)~     influenza vaccine in healthy male and female adults, 18 through 49 years of age .~   "
83035|NCT02480088|"~     Opioid-based intravenous patient-controlled analgesia (IV-PCA) offers excellent pain control,~     however, its use inevitably increases the incidence of postoperative nausea and vomiting~     (PONV). Ramosetron and palonosetron are commonly used 5-HT3 antagonists for the prevention~     and treatment of PONV. It is not clear which one has superior antiemetic efficacy for the~     prevention of PONV in patients using opioid-based IV-PCA. The antiemetic efficacy of 5HT3~     antagonists may be influenced by polymorphism of ABCB1, a drug-transporter gene. This study~     evaluates relative antiemetic efficacy of ramosetron and palonosetron in patients using~     IV-PCA after spinal surgery and impact of ABCB1 polymorphism on the antiemetic efficacy of~     the ramosetron and palonosetron. The incidence and intensity of PONV during postoperative 48~     h will be assessed. ABCB1 polymorphisms 3435C>T and 2677G>T/A will be evaluated in all~     patients.~   "
83036|NCT02480075|"~     The purpose of this study is to (a) evaluate the treatment approaches and changes in~     treatment regimens utilized by clinicians when genetic testing is performed in the clinic;~     and (b) create a patient data registry to identify genetic factors that influence treatment~     outcomes in pain management.~   "
83041|NCT02480010|"~     This study will evaluate the efficacy and safety of intravenous (IV) pertuzumab in~     participants with hormone-refractory prostate cancer who have had no previous chemotherapy.~     Participants will be enrolled in two stages, the first (Cohort A) at a lower 420-mg dose and~     the second (Cohort B) at a higher 1050-mg dose based upon observations in Cohort A. Up to 50~     participants may enter either cohort, for a total enrollment between 46 and 73 participants~     across 9 study centers.~   "
84433|NCT02461862|"~     Cross-sectional cohort study to evaluating pain and vital signs variations (blood pressure~     and radial pulse) during the placement of the intrauterine device.~   "
83042|NCT02479997|"~     This study aimed to compare detection rate between dual sentinel node staining method using~     mixture of indocyanine green (ICG) with radioisotope(RI), and RI only.~      To identify the first lymph node(s) along the lymphatic drainage pathway from the primary~     tumor in the breast cancer using RI only has several disadvantages such as invisibility,~     interference. As ICG can be visualized with a fluorescence imaging system, we expects dual~     sentinel lymph node staining method had better outcomes.~   "
83043|NCT02479984|"~     The purpose of this study is to evaluate the role of routine Staging Laparoscopy in patients~     with potentially resectable pancreatobiliary cancer.~   "
83044|NCT02479971|"~     A prospective, randomized study will be performed in patients undergoing laparoscopic sleeve~     gastrectomy (LSG) as bariatric procedure. The patients will be randomized into 2 groups:~     those patients undergoing an intra-abdominal lavage with normal saline (Group 1) and those~     undergoing an intra-abdominal lavage with a gentamicin-clindamycin solution (Group 2).~     Postoperative pain and C reactive protein will be investigated 24 hours after surgery.~   "
83045|NCT02479958|"~     Despite of the decline of dental caries, this disease is still common in polarized groups~     affecting children. Therefore, the aim of this randomized blind in vivo study was to compare~     the antimicrobial effect of two antimicrobial therapies in deciduous carious dentin. Thirty~     two patients aging from 5 to 7 years old had partial caries removal in deep carious dentin~     lesion in deciduous molar and were divided in three groups: 1. Control - chlorhexidine and~     resin modified glass ionomer cement (RMGIC); 2. LEDTB - antimicrobial photodynamic therapy~     (APDT) with LED (light emission diode) associated with toluidine blue orto dye solution and~     RMGIC; 3. LMB - APDT with laser associated with methylene blue dye solution and RMGIC. The~     patients were submitted to initial clinical and radiographic examination and demographic~     features were evaluated by biofilm, gingival, and dmft/dmfs indexes, besides clinical and~     radiographic follow up at 6 and 12 months after the treatments. The carious dentin was~     collected before and after each treatment and the number of Streptococcus mutans,~     Streptococcus sobrinus, Lactobacillus casei, Fusobacterium nucleatum, Atopobium rimae and~     total bacteria were established by quantitative PCR.~   "
83046|NCT02479945|"~     The investigators will compare tumor marker levels, including PSA, in samples taken from a~     peripheral upper limb vein and the internal iliac veins. These will be collected from~     patients who are scheduled for prostatectomy as part of their standard of care for prostate~     cancer. A selective internal iliac vein sampling procedure will be performed in~     Interventional Radiology. Venous samples will be correlated with prostatectomy specimens. The~     aim is to predict the side of the prostate containing tumor.~   "
83047|NCT02479932|"~     The aim of study is to compare skin-to-delivery time and postoperative morbidity between~     extraperitoneal cesarean and transpirational cesarean.~   "
83048|NCT02479919|"~     The purpose of the study is to test a new treatment of social cognition deficits in patients~     with schizophrenia or schizoaffective disorder by transcranial magnetic stimulation~     (theta-burst). The study will also identify clinical, psychomotor and cognitive variables~     that are the most sensitive to treatment, and estimate the most sensitive treatment target~     between patients.~   "
83049|NCT02479906|"~     The purpose of the present study is to evaluate the safety and efficacy of Brainsway Deep TMS~     (DTMS) for the treatment of PTSD.~   "
83050|NCT02479893|"~     Given the limited existing data regarding the advantages and limitations of the existing~     techniques in the removal of colonic polyps the investigators designed a prospective study in~     order to compare cold snare vs hot snare vs argon plasma coagulation for the compete removal~     of colonic polyps of the left colon up to a diameter of 0.8cm.~   "
83051|NCT02479880|"~     The primary objective of this study is to characterize the long term (ie, 96 weeks of follow~     up) bone safety profile of open-label tenofovir disoproxil fumarate (tenofovir DF) treatment~     in CHB-infected adolescents. This includes prospectively evaluating and comparing the bone~     mineral density (BMD) change between CHB-infected adolescents 12 to < 18 years of age treated~     with tenofovir DF in European treatment centers who are assigned to one of two schedules for~     renal and bone laboratory monitoring and BMD measurement.~   "
83052|NCT02479867|"~     Comparative randomized, single dose, two-way crossover open-label study to determine the~     bioequivalence of Cefadroxil from Duricef 1 gm Film Coated tablets(Smthkline Beecham~     Egypt,LLC affiliated co. to GalaxoSmithKline ) and Biodroxil 1 gm Film Coated tablets (Kahira~     Pharm &Chem .Ind. Co . for Novartis Pharma ) after a single oral dose administration of each~     to healthy adults under fasting conditions.~   "
83053|NCT02479854|"~     Comparative randomized, single dose, two-way crossover open-label study To investigate the~     bioequivalence of Montelukast from 5 mg chewable tablets(Sandoz, Egypt) and Singulair5 mg~     chewable tablets(Merck & Co. Inc. ), after a single oral dose administration of each to~     healthy adults under fasting conditions,~   "
83054|NCT02479841|"~     Chronic obstructive pulmonary disease (COPD) is a major cause of mortality and disability,~     and by 2020, it is expected to be the third leading cause of mortality worldwide. COPD is a~     major public health concern and has considerable impact on health and quality of life.~      For this study an evidence based self-management program is developed, the purpose of the~     study is to see if this self-management program, in collaboration between specialized health~     services and municipality health services, improves patients with COPD health-promoting~     competence, coping and quality of life, and reduces health service costs.The study has a RCT~     design.~   "
83055|NCT02479828|"~     This study evaluates the effect of fascia iliaca compartment block (FICB) in the management~     of acute post -surgical pain in hip fracture patients and in the appearance of chronic post~     -surgical hip pain, by means of von Korff Graded Chronic Pain Scale -modified for hip pain in~     Greek.~      Half of the patients will not receive fascia iliaca compartment block.~   "
83091|NCT02479360|"~     Neurofibromatosis 1 (NF1) is a common inherited condition that affects the skin, bone and~     nervous system. The complications of NF1 are widespread and can lead to varied difficulties~     dependent on the location of neurofibromas and their secondary complications. At present~     evaluation of the effect of treatments in NF1 is based on a clinician's neurological~     assessment, magnetic resonance imaging and positron emission tomography but it is apparent~     that imaging results do not always link with clinical and functional changes in an~     individual. This study aims to evaluate the reliability (stability) of a range of functional~     standardised outcome measures in adults with NF1.~   "
83056|NCT02479815|"~     The purpose of the study is to assess the safety of iron supplementation in MNPs. A~     quasi-experimental matched-control cluster design will be used in, purposely selected, 18~     intervention and 18 matched-control clusters of Oromia and South Nations Nationalities and~     People (SNNP) regions of Ethiopia. A total of 2340 infants 6-11 months of age, from~     intervention and non-intervention clusters will be enrolled and followed longitudinally for~     12 months. Morbidity data using standardized questionnaire, will be collected at baseline,~     and every two weeks for a period of 12 months~      Research questions to be answered in this study are:~        1. Is the provision of low dose iron-containing Micronutrient Powders (MNPs) to young~          children with or without iron deficiency safe, as assessed by their morbidity from~          infectious diseases?~        2. What is the impact of the provision of low dose iron-containing Micronutrient Powders~          (MNPs) to young children on (body) iron status? Morbidity data will be collected at~          baseline, and every two weeks in the same cohort of children.~      Body iron status will be assessed at baseline and endline as measured by serum ferritin,~     serum transferrin receptor, hemoglobin concentration, CRP and AGP.~      In addition data on the following outcomes will be collected in these children:~        1. Anthropometry (weight, height, MUAC) every 4 months~        2. Breastfeeding status and consumption of processed complementary food portions in the~          previous week -every 4 months~        3. Compliance to study intervention.~   "
83057|NCT02479802|"~     Pilot, phase II, prospective, open-label, uncontrolled study of plasma exchange with 5%~     albumin in 10 subjects having a definite, possible, or probable diagnosis of Amyotrophic~     Lateral Sclerosis (ALS).~   "
83058|NCT02479789|"~     Intra operative Nerve Monitoring ( IONM ) is rapidly becoming the standard of care for~     thyroid surgery to prevent injury to the recurrent laryngeal nerve. However the laryngo~     tracheal reflexes need to be adequately suppressed to permit proper utilization of intra~     operative nerve monitoring. Increasing the depth of anesthesia to achieve this often leads to~     side effects. Intravenous lidocaine infusion has been shown to be effective in blunting these~     reflexes. The planned study intends to look at the efficacy of intravenous lidocaine infusion~     in decreasing the amount of anesthesia medications needed to suppress the reflexes. Also the~     study looks at the analgesic and anti emetic properties of intravenous lidocaine infusion~     post operatively by measuring these outcomes.~      The study is designed as a double blinded randomized controlled trial with 30 subjects in the~     group who will receive intravenous lidocaine during surgery and 30 subjects in the group who~     will receive placebo. Blunting of the laryngo tracheal reflexes intra operatively will be~     recorded as the primary outcome. The amount of anesthesia medications, the post operative~     patient comfort level, pain control, usage of narcotic pain medications, nausea, vomiting~     will be recorded as secondary outcomes.~   "
83059|NCT02479776|"~     The bone marrow mononuclear cell fraction has been used as therapy after myocardial~     infarction and in dilated cardiomyopathy in adults. The absence of adult co-morbidities may~     enhance the potential effectiveness of pediatric stem cells.This study is a randomized,~     crossover, placebo controlled pilot study to primarily determine the safety and feasibility~     of stem cell intracoronary therapy in children. Secondary end points are MRI measurements and~     NTproBNP.~      Ten children (mean age 7.2 years, range 2.2-14.1, 6 male) with dilated cardiomyopathy (NYHA/~     Ross Classification 2-4) will be recruited. Bone marrow aspiration MRI and cell injection are~     performed under the same anaesthetic. Patients will be crossed over at 6 months.~   "
83060|NCT02479763|"~     In the investigators' institution, the failure rate for thoracic epidural blocks is 23.1%.~     This stems from the prevalence of trainee operators coupled with the non-specific nature of~     loss-of-resistance. In the current randomized trial, we will set out to compare conventional~     and epidural waveform analysis-confirmed loss-of-resistance. The investigators' research~     hypothesis is that loss-of-resistance combined with epidural waveform analysis will decrease~     the failure rate of thoracic epidural blocks.~   "
83061|NCT02479750|"~     This study evaluates the performance of ColdZyme® mouth spray on prevention of common cold~     symptoms on experimentally induced rhinovirus upper respiratory tract infection in healthy~     volunteers. Half of participants will receive ColdZyme® mouth spray while the other half will~     receive placebo.~   "
83062|NCT02479737|"~     Postoperative bleeding is a common consequence after heart surgery which can significantly~     impact outcomes and costs [Wynne R, Christensen MC, Dixon B]. When bleeding occurs, reliable~     postoperative blood evacuation of the pleural, mediastinal and pericardial spaces with chest~     tubes is imperative to facilitate pulmonary re-expansion and mediastinal decompression as the~     patient recovers. When postoperative blood evacuation is inadequate, retained blood~     complications can result (herein described as the Retained Blood Complications (RBC). RBC is~     the presence of post-operative pericardial and/or pleural fluid or blood that is diagnosed~     and may necessitate drainage in the acute or sub-acute setting. The need for treatment and~     interventions for these conditions represents an impediment to patient recovery and involves~     both resource and economic consumption for a heart program and the healthcare system at~     large.~      Clinically, Retained Blood Complications (RBC) can be recognized acutely or subacutely. When~     it presents acutely, it is usually fresh thrombus around the heart or lungs presenting as~     tamponade or hemothorax. When it presents subacutely, it results in bloody pleural or~     pericardial effusions. These effusions are often driven by the breakdown of remaining~     thrombus. Once RBC occurs, subsequent procedures may be needed to remedy it.~      A recent review of the literature indicated that additional procedures for RBC are~     demonstrated in approximately 15% to 20% of patients after heart surgery. In a prospectively~     collected United States Nationwide Inpatient Sample (NIS) data from 2010, RBC could be~     demonstrated in 17% of patients. In this analysis, mortality was doubled from 4% to 8%,~     length of stay was increased by 5 days, and average costs were 55% higher. Patients with RBC,~     therefore, represent an increased at risk population for complications and costs.~      Postoperative obstruction of conventional chest tubes with blood and other fibrinous material~     in the setting of postoperative bleeding contributes to RBC. (Shalli) In a recent study of~     postoperative cardiac surgery patients at the Cleveland Clinic, 36% of patients were found to~     have evidence of chest tube obstruction . Active Clearance with PleuraFlow has been shown to~     prevent chest tube clogging, and reduce RBC.~   "
83063|NCT02479724|"~     Comparison of Blood Pressures obtained with the Pulse Decomposition Algorithm and~     Intra-Arterial Catheters in ICU Patients~   "
83064|NCT02479711|"~     The aim of the present study is to evaluate the clinical performance of EQUİA restoration~     material in Class II cavities comparing with a resin-based composite / dentin bonding system.~   "
83103|NCT02479204|"~     The aim of the study is to investigate the safety of the concomitant administration of~     ACT-334441 with cardiovascular drugs.~   "
83104|NCT02479191|"~     The LUCY Study is a prospective, consecutively enrolling, non-randomized multi center~     post-market registry to evaluate the low profile Ovation ® Abdominal Stent Graft Platform~     when used in the endovascular treatment of female patients.~   "
84578|NCT02459964|"~     The goal of this clinical research study is to compare fentanyl nasal spray with a standard~     drug given by vein (hydromorphone hydrochloride) to help reduce pain related to cancer in~     patients coming to the emergency department.~   "
83065|NCT02479698|"~     Any time the words you, your, I, or me appear, it is meant to apply to the potential~     participant.~      The goal of this clinical research study is to learn if giving cytotoxic T lymphocytes (CTLs)~     can help to control BK viral infection and JC viral infection. Researchers also want to learn~     about the safety of giving CTLs to patients with BK and/or JC infection.~      CTLs are made from donated blood cells that are grown in the laboratory and are designed to~     kill viruses that can cause infections.~      This is an investigational study. The use of CTLs to treat BK infection and JC infection is~     not FDA-approved or commercially available. CTLs are currently being used for research~     purposes only.~      Up to 100 participants will be enrolled in this study. All will take part at MD Anderson.~   "
83066|NCT02479685|"~     This prospective randomized pilot study is aimed to verify if the operative time of a~     standard laparoscopic sacral colpopexy associated to subtotal hysterectomy for the treatment~     of POP could be further reduced using PKS BILL: bipolar laparoscopic loop (a laparoscopic~     loop using advanced bipolar energy) (Olympus Medical Systems Corp, Tokyo) and PKS PlasmaSORD~     (Solid Organ Removal Device) vs. conventional monopolar hook and conventional mechanic~     morcellator.~   "
83067|NCT02479672|"~     This is a prospective randomized clinical study to be performed in adult patients ages 18 and~     older who are undergoing surgical procedures requiring endotracheal intubation. Adult~     patients will be randomized to either the VideoTrac® laryngoscope or direct laryngoscopy and~     the time to intubation will be compared and recorded. Patients in both treatment arms will~     receive manual inline stabilization. The study hypothesis is that the time to endotracheal~     intubation will be decreased in the VividTrac® video laryngoscope group when compared to~     direct laryngoscopy.~   "
83068|NCT02479659|"~     This randomized evaluation measured the impact of two levels of support for the integration~     of infant and postpartum maternal HIV testing with routine immunization services in Southern~     Zambia on the number of postpartum maternal HIV tests, infant HIV tests, and 1st dose~     diphtheria, pertussis, and tetanus (DPT1) vaccines.~   "
83069|NCT02479646|"~     This is a single center, double-blind, randomized, comparative pharmacokinetic and~     pharmacodynamic study of MYL-1401H and Neulasta (from EU and US source) in Normal Healthy~     Volunteers.~   "
83070|NCT02479633|"~     Background: The aim of present clinical study was to evaluate the predictive values of~     baseline inter-dental papilla height (IPH), avascular exposed root surface area (AERSA) and~     inter-dental clinical attachment loss (CAL) measurements on complete root coverage (CRC) of~     single gingival recession (GR) defects treated with coronally advanced flap and connective~     tissue graft technique (CAF+CTG).~      Material and Methods: The study group included 65 females and 57 males, aged between 20 and~     42 years. A total of 122 recession defects without CAL and with an amount of CAL equal or~     smaller to the buccal CAL , located at upper and lower incisors and canines were treated with~     CAF+CTG. IPH, AERSA and CAL parameters were analyzed for possible correlation with CRC after~     6 months.~   "
83071|NCT02479620|"~     This is a prospective, multi-center, randomized pilot study to document the effects of~     adventitial delivery of dexamethasone after atherectomy-based revascularizations of lesions~     below the knee in symptomatic patients with critical limb ischemia (CLI).~   "
83072|NCT02479607|"~     The purpose of this study is to evaluate the effects of an interactive Information and~     Communication Technologies (ICT) -platform for use in a smartphone or tablet in patients~     treated with neoadjuvant chemotherapy for breast cancer. The hypothesis is that clinical~     management will be improved and costs reduced and safe and participatory care promoted, when~     patients report symptoms in an application which provides self-care advice and instant access~     to professionals.~   "
83073|NCT02479594|"~     In a randomized controlled study design, n = 58 treatments of patients with depression were~     to be conducted under a feedback-condition, in which the therapist would receive feedback~     five times within 20 treatment sessions. The competence-feedback includes detailed feedback~     about 14 different aspects of therapist behavior. The control group includes n = 58 further~     treatments within which therapists do not receive any competence-feedback (treatment as~     usual; TAU).~   "
83074|NCT02479581|"~     This study evaluates the enhanced recovery after surgery (ERAS) concept over conventional~     postoperative care in patients with heart valve disease undergoing cardiac surgery with~     cardiopulmonary bypass. Half of participants will adherence to the ERAS, while the other half~     will under the conventional postoperative care.~   "
83075|NCT02479568|"~     The primary aim is to examine both the acute and chronic effects of hesperidin consumption~     from 100% Florida orange juice in various doses on functional and systemic markers associated~     with cardiovascular disease (CVD) risks.~   "
83076|NCT02479555|"~     This is a prospective, multi-center, randomized pilot study to document the effects of~     adventitial delivery of dexamethasone after balloon angioplasty of lesions below the knee in~     symptomatic patients with critical limb ischemia (CLI).~   "
83077|NCT02479542|"~     The worldwide prevalence of open wounds is estimated to be approximately 200 million per~     year. Negative Pressure Wound Therapy (NPWT), the application of a controlled vacuum to an~     open wound cavity, has been clinically demonstrated in developed nations to speed the healing~     time of open wounds by a factor of two or more, and to aid in complete recovery with less~     scar tissue. Use of NPWT devices has not been feasible in an limited-resource settings due to~     cost, bulk, and requirement for consistent electricity. This study aims to follow up prior~     clinical studies that have established the safety and efficacy of simplified NPWT, by~     assessing changes in wound closure time and wound contraction rate when simplified NPWT is~     used in a limited-resource setting.~   "
83078|NCT02479529|"~     After cardiac surgery, vasoplegic syndrome is a hemodynamic state characterized by profound~     hypotension associated with a decrease in systemic vascular resistance. The care of this~     disease is based on the intravenous administration of a vasopressor, usually norepinephrine.~     During the recovery phase, weaning of norepinephrine, is an important step in which any lack~     of preload (blood volume) initial or secondary can be, and increase tissue malperfusion.~   "
83105|NCT02479178|"~     BIND-014 (docetaxel nanoparticles for injectable suspension) is being studied in patients~     with advanced urothelial carcinoma, cervical cancer, cholangiocarcinoma or carcinomas of the~     biliary tree and squamous cell carcinoma of the head and neck.~      Ferumoxytol imaging will also be investigated at US sites as an exploratory endpoint.~   "
83079|NCT02479516|"~     The investigators are adopting an intervention which has been tested in Canada to the~     Philippine setting. The program will be called Community Health Assessment Program in the~     Philippines (CHAPP). The main goal of CHAPP is to decrease diabetes and its complications by~     implementing a community-based program.~      The CHAPP intervention will be modified so that it will be applicable to the Philippine~     setting and other Low and Middle Income Countries. The initial plan for the program is that~     trained volunteers or health workers will be running the CHAPP sessions 2-hours a week in a~     community location for residents in the community. During the CHAPP session, volunteers will~     administer a questionnaire and do basic measures (assessing the weight, height, blood~     pressure, waist measurement). The questions can be entered into a laptop/tablet/cell-phone or~     written into a paper questionnaire depending on the abilities of the volunteer to use~     computers. Based on the data gathered, the volunteers will identify residents who have a high~     risk of developing diabetes (including long term complications of diabetes such as~     hypertension), educate them regarding what to do to avoid having diabetes (by doing exercise,~     improving their diet, and avoiding unhealthy lifestyle), and refer them to local health care~     when needed. Residents who have high risk of developing diabetes will be referred to have~     their blood sugar checked. Residents who have diabetes or complications of diabetes will be~     checked to see if they are being treated properly; if not they will be referred to the local~     doctor for treatment and medication. All the information regarding the CHAPP sessions will be~     sent to the Local Public Health Office or other designated local health centre so that they~     will be able to educate, monitor, and attend to residents who have diabetes or who have high~     risk of developing diabetes.~   "
83080|NCT02479503|"~     The study focuses on the antibiotic prophylaxis use in adult heart transplantation in France.~   "
83081|NCT02479490|"~     This is a multicenter prospective study that includes all patients with metastatic Renal Cell~     Cancer (RCC) pre- treated with VEGFR TKI in eight Italian cancer centers.~      Everolimus is formulated as tablets of 5-10 mg strength, blister-packed under aluminium foil~     in units of 10 tablets. Prednisone will be dispensed to patients at the dose of 5 mg twice~     daily (BID). Everolimus at dose of 10 mg (one 10 mg tablet or two 5 mg tablets). Both drugs~     will be self-administered orally, continuously from Day 1 (Visit 2) until progression of~     disease, unacceptable toxicity, death or discontinuation for any other reason.~      A treatment cycle consists of 28 days.~   "
83082|NCT02479477|"~     The quality of life and daily activities can be affected by muscleskeletal pain and one of~     the forms of assessment is through the SF-36 questionnaire. The investigators know that the~     working kinesitherapy is a way to improve the quality of life.~   "
83083|NCT02479464|"~     The Mayo Clinic psychiatric pharmacogenomic team has developed a pharmacogenomic algorithm~     that has been designed to improve the effectiveness and safety of antidepressant medications~     by providing guidance in medication selection and appropriate dosing. This algorithm has been~     incorporated into a new genotyping interpretative report. This report is now available from~     AssureRx. The pharmacogenomic algorithm is based on genotyping both copies of four~     informative genes. These four genes are: 1) the Cytochrome P450 2D6 gene; 2) the Cytochrome~     P450 2C19 gene; 3) the Serotonin Transporter gene (SLC6A4); and 4) the Serotonin 2A receptor~     gene (5HTR2A). Though this algorithm is not yet part of the universal standard of care, Mayo~     clinicians have found it helpful in guiding treatment decisions at Mayo Clinic Rochester.~   "
83084|NCT02479451|"~     This clinical trial examines whether nasal theophylline administration can improve olfaction~     and nutrition in hemodialysis patients.~   "
83085|NCT02479438|"~     The purpose of this registry is to evaluate information to determine which operations and~     treatments for gastroesophageal reflux disease or similar diseases of the stomach, esophagus~     or digestive tract are providing the most benefit including the long-term effects of~     treatment (or no treatment) and the progression of the disease over time.~   "
83086|NCT02479425|"~     Several studies were searched the preventive measures of bed sores. Although repositioning is~     the mainstay in most preventive measures, there is no evidence to recommend specific turning~     regimen.~      The aim of this study is to comparative the impact of the two points repositioning in lateral~     lying position on the right and left versus the traditional three points repositioning on the~     right, back, and left in the occurrence of bed sores.~      This study was conducted on 150 patients admitted to the critical care department of~     Alexandria Main University Hospital after obtaining an informed consent from their relatives.~      The investigators excluded patients who: have active or healed bed sores.~      Patients were randomly divided into two groups by allocated randomization:~        -  Group 1: traditional three points rotation.~        -  Group 2: two points rotation.~   "
83087|NCT02479412|"~     This study will be a randomised, double-blind, multiple dose (14 days), placebo-controlled,~     multi-center study to assess efficacy and safety of three dose levels of AZD7594, given once~     daily by inhalation, in patients with mild to moderate asthma.~   "
83088|NCT02479399|"~     The objective of this survey is to confirm the safety of Suglat Tablets~   "
83089|NCT02479386|"~     This study seeks to better characterize relationships between visual function and the~     progression (worsening) of geographic atrophy (GA) due to age-related macular degeneration~     (AMD). The study is also intended to generate new information on the relationship between~     genetics and GA progression. This is a global, prospective, multicenter, epidemiologic study~     enrolling participants with GA secondary to AMD. The study visits are scheduled to occur~     every 6 months. The anticipated duration of the study is up to 48 months. There is a planned~     interim analysis around the 2-year time window for the study.~   "
83090|NCT02479373|"~     This research is being done to see if resistance exercise (RE) is safe and has a positive~     effect on children and young adults with juvenile idiopathic arthritis (JIA).~      JIA is an inflammatory autoimmune disease that can cause severe impairment and disability.~     JIA can cause bone loss and decreased muscle strength. The medications used to treat JIA can~     also have negative effects on growth and development, strength, and ability to function. RE~     is performing movements in a slow and controlled fashion (i.e., no speeding up or using force~     in the lifting and lowering of the weight) to lessen force on the joints and tissues. This~     study will be using Ren-Ex exercise equipment to perform RE.~      Currently the American College of Rheumatology recommends exercise for patients with~     arthritis. This exercise includes range of motion exercise to protect joint mobility as well~     as low resistance and aerobic exercise (AE) to protect muscle mass, bone health, and fitness.~     However, a recent study showed no major differences in functionality or quality of life~     between patients who performed AE and those who did not perform AE. There is a need for more~     data on the impact of RE on children with JIA. Children and young adults aged 10 to 21 with~     juvenile idiopathic arthritis may join.~   "
83106|NCT02479165|"~     The aim of this randomized controlled study is to shed light on the analgesic properties and~     side-effect profile of an opiod-based regimen as opposed to an Ibuprofene based regimen.~   "
83092|NCT02479347|"~     The development of surgical site infections (SSI) in clean-contaminated surgery is regarded~     as being preventable. Known to be effective in the prevention of surgical site infection are~     the adequate sterilization of the surgical instruments, asepsis during operation, antibiotic~     prophylaxis where indicated, and certainly the preparation of the skin at the incision site,~     since the patient's skin is the principal source of bacterial contamination of the wound.~     This study aims to investigate the efficacy in prevention of surgical site infection in clean~     surgery, using two different standardized methods of skin preparation: povidone-iodine 10%~     aqueous solution from 1.5 liter bulk bottle, versus tinted 2% chlorhexidine in 70% isopropyl~     alcohol in a single-dose applicator. To reduce the variables involved, a single-center study~     will enroll a homogeneous population, undergoing breast cancer surgery.~   "
83093|NCT02479334|"~     This study aims to investigate the effect of spices on gene expression of pathways associated~     with glucose homeostasis, oxidative stress and inflammation, in the postprandial phase in~     healthy human subjects.~   "
83094|NCT02479321|"~     Crude incidence rate in Spain of hip fracture in people over 65 years was 511 cases per~     100,000 in 2002. About 30% of patients die in the first year. Cardiocirculatory complications~     during and after surgery partly explain this high morbidity and mortality. Most patients are~     frail and with multicomorbidity. Perioperative Goal-Directed Hemodynamic Therapy (PGDT) based~     on noninvasive continuous monitoring of blood pressure, heart rate, oxygen saturation,~     cardiac output, cardiac index, stroke volume and stroke volume index can reduce perioperative~     complications and improve survival. The objective of our study is to assess the efficacy of a~     goal-directed hemodynamic therapy during the perioperative period in reducing intraoperative~     complications, especially hemodynamic instability, postoperative complications and 1-year~     survival. Patients and Methods: non-randomized intervention study with a historical control~     and 1-year follow-up. Patients older than 64 years with non-traumatic hip fracture requiring~     surgical intervention. In the control group blood pressure, heart rate, oxygen saturation and~     clinical situation besides respiratory parameters were recorded at intervals of 15 minutes.~     In the intervention group PGDT based on noninvasive monitoring will be performed. The main~     outcome will be the percentage of patients with hemodynamic instability complications and the~     average of complications per patient. Secondary outcomes: intraoperative complications,~     postoperative complications and survival at 12 months of surgery.~   "
83095|NCT02479308|"~     This study will evaluate the effects of ALKS 5461 on QT intervals in healthy volunteers as~     well as evaluate the safety and tolerability of ALKS 5461.~   "
83096|NCT02479295|"~     This study compares the result of straight versus coiled Tenckhoff catheters for peritoneal~     dialysis patients. Recent meta-analysis of the peritoneal dialysis catheter type was in favor~     of straight catheters. The effects of straight versus coiled peritoneal dialysis catheters,~     however, are unclear. The investigators design an adequately powered randomized controlled~     study to evaluate the two types of double-cuffed peritoneal dialysis catheters. The primary~     objective is to assess whether straight peritoneal dialysis catheters can reduce the risk of~     catheter dysfunction that requires intervention. The investigators estimate that they would~     need to enroll 132 incident peritoneal dialysis patients in each group for the study to have~     80% power to detect a difference between 7% and 15% in the primary endpoint of catheter~     dysfunction requiring intervention.~   "
83097|NCT02479282|"~     Effect of natural cesarean section in comparison to traditional cesarean section on maternal~     and fetal recovery.~   "
83098|NCT02479269|"~     The purpose of this study was to investigate the effects of 8 weeks of aerobic exercise on~     serum concentrations of Brain Natriuretic Peptide and C - reactive protein in patients with~     cardiovascular disease. Patients were divided randomly into two groups: control and~     experimental aerobic group. This study was done with two - stage blood sampling: at the~     beginning and at the end of the treatment phase. All subjects were requested to avoid any~     exercise at least 48 hours before blood sampling. To study Brain Natriuretic Peptide and C -~     reactive protein changes, 5 milliliters of blood were taken from patient's brachial vein.~     Blood samples for subsequent measurements were frozen immediately and transported to the~     Hormone Laboratory for serum separation. The experimental group did the aerobic exercise~     programs for 8 weeks for 3 sessions per week and the control group did not receive any~     training. After completion of training, the final blood samplings were performed. Exercise~     intensity according to the heart rate remained stable until the last week. Brain Natriuretic~     Peptide and C - reactive protein levels were measured by ELISA tests. All statistical~     analysis were done using SPSS software (version 16) and at the significance level of p≤ 0.05~   "
83099|NCT02479256|"~     Comparison between Clomiphene citrate and Tamoxifen for induction of ovulation in women with~     PCOS.~   "
83100|NCT02479243|"~     Collateral circulation supports brain tissues to maintain blood perfusion in cerebral~     ischemic stroke and are of great benefit for a better outcome. A non-invasive approach~     relative to currently widely used digital subtraction angiography (DSA) is needed. ASL~     (arterial spin labeling) is a novel perfusion method without contrast agent injection and~     features both temporal and cerebral blood flow(CBF) information. The investigators applied~     multiple post labeled delay(PLD) time to pseudo-continuous Arterial Spin Labeling (3D pCASL)~     MRI and subtraction images were obtained to evaluate the collateral robustness and~     quantitatively assess the collateral perfusion in patients with unilateral middle cerebral~     artery atherosclerotic stenosis and the ability to predict future stroke recurrence.~   "
83101|NCT02479230|"~     This pilot clinical trial studies the safety of a dendritic cell vaccine when given with~     gemcitabine hydrochloride in treating patients with breast cancer that has spread beyond the~     breast and local lymph nodes to other organs in the body. The vaccine is made up of natural~     cells found in the blood, called dendritic cells, and peptides, or small fragments of protein~     which are loaded onto the dendritic cells. This combination may help activate the immune~     system against stromal cells, which are cells that help cancer cells survive in the body.~     Gemcitabine hydrochloride is a chemotherapy drug that is given before the vaccine to help~     shrink the tumor and control cells that may interfere with the activity of the vaccine.~     Interfering with the stromal cells that help support the growth of cancer cells may lead to~     the death of the cancer cells.~   "
83102|NCT02479217|"~     The primary objective of this study is to observe safety and tolerability of Xeloda as used~     in medical practice, alone and in combination with docetaxel.~   "
83110|NCT02479113|"~     Besides maternal hyperglycemia, a strong link between maternal pregravid weight/maternal~     triglyceride(Tg) levels and fetal growth/childhood obesity/metabolic syndrome in offspring~     has been demonstrated in largely Caucasian populations. This study aims to explore the link~     between maternal hypertriglyceridemia and offspring health in Asians.~   "
83111|NCT02479100|"~     The aim of this study is to determine if the addition of Contrast Enhanced Spectral~     Mammography (CESM) to standard diagnostic imaging, results in a decision regarding patient~     management - discharge, follow-up, surgery or treatment - being made sooner than it would if~     the patient had followed the standard course of investigations and review.~      The investigators also intend to compare CESM with MRI. Images and pathology results from~     patients who undergo both CESM ans MRI will be reviewed retrospectively for detection of~     abnormality and identification of type of abnormality, i.e. is it a cancer or not?~   "
83112|NCT02479087|"~     The purpose of this study is to assess the role of a FVIII/VWF complex concentrate (Emoclot)~     in successfully inducing immune tolerance (I.T.I.) in patients with Haemophilia A with~     inhibitors, including patients at high risk of failure.~   "
83113|NCT02479074|"~     In this study the investigators wish to explore the difference in 24 hr. cough counts~     measured using the Hull Automated Cough Counter (HACC), from baseline and after two weeks~     treatment with either montelukast or prednisolone in patients with an NO measurement of ≥30~     ppb at screening.~   "
83114|NCT02479061|"~     The purpose of this observational study is to determine the proportion of patients with a~     score greater than 3/10 to the questionnaire PALLIA-10.~      This questionnaire is a tool provided by the French Society for Palliative Cares, aiming at~     helping the providers of care to identify patients who would require palliative cares.~      According to the notice of the questionnaire, patients with a score greater than 3 would be~     taken in charge by a palliative care team. Considerong the 10 itmes of this questionnaire, it~     seems that a large majority of patients would have a score greater than 3 in the context of~     anti cancer centers.~      To date, palliative teams are not designed to take in charge such an amount of patients.~   "
83115|NCT02479048|"~     The primary goal is to characterize the acute effects of avocado intake on glycemic and~     satiety/ appetite responses in relatively healthy overweight / obese adults. The secondary~     goal is to investigate risk factors for cardio-metabolic disease.~   "
83116|NCT02479035|"~     The purpose of this study is to investigate the relative bioavailability and~     absorption/kinetic profile of red raspberry polyphenols consumed with a meal and further to~     determine the relationship of these findings on meal-associated metabolic- oxidative- and~     inflammatory- responses in relatively insulin sensitive and insulin resistant individuals.~   "
83117|NCT02479022|"~     This trial is conducted in Europe. The aim of the trial is to investigate the safety,~     tolerability, pharmacokinetics (the exposure of the trial drug in the body) and~     pharmacodynamics (the effect of the investigated drug on the body) of insulin 320 in healthy~     subjects.~   "
83118|NCT02479009|"~     Aim:~      The aim of this study is to analyze if fluoroscopy is as accurate as computed tomography in~     diagnosing displacement of acute scaphoid waist fractures.~      Primary null hypothesis:~      Fluoroscopy has comparable sensitivity, specificity, accuracy, positive and negative~     predictive values compared with computed tomography for the diagnosis of displacement of~     acute scaphoid waist fractures.~      Secondary null hypothesis:~      All fractures diagnosed as non-displaced and treated without surgery are healed on~     radiographs and discharged from care within 6 months of injury.~   "
83119|NCT02478996|"~     This study will evaluate, if an intensive individually adaptated training program via online~     supervision during neoadjuvant therapy will improve lung function and reduce pulmonary~     complications following esophagectomy for Barrett's cancer.~   "
83120|NCT02478983|"~     The investigators conduct this study to evaluate the clinical efficacy of size 1 and 1.5~     supreme LMA compared to proseal LMA for infants weighing <10kg.~   "
83121|NCT02478970|"~     The corneal endothelium plays an important role in regulating stromal hydration and~     maintaining the transparency of the cornea. For evaluating the cornea, the most important~     parameters are corneal endothelial morphology and central corneal thickness. The specular~     microscope does this. The image in specular microscope is obtained by the specular reflex at~     a regular, smooth-surfaced interface of two refractive indices, with the angle of the light~     passing into the cornea equal to the angle of reflection to the observer. To obtain a clear~     image, the endothelial apical surface must be smooth and uniform and the cornea must be~     transparent. Nowadays different types of specular microscope exist.~      The investigators propose to compare the endothelial cells with two specular microscopes: the~     Konan SP4000, which is the current model and used for standard of care, to the Nidek CEM-350,~     which is a newly marketed device.~      The investigators would like to evaluate the patients in the clinic and have assessments~     completed with both specular microscopes.~      Nidek will be loaning the specular microscope, NIDEK CEM-530, for the study.~   "
83122|NCT02478957|"~     This is a randomized, placebo- and active-controlled, 2-period crossover, 2 cohort study in~     adult patients with indolent systemic mastocytosis (ISM).~      The purpose of the study is to determine the efficacy and safety profile of PA101 delivered~     via eFlow high efficiency nebulizer in patients with ISM who are symptomatic despite using~     standard treatments.~   "
83123|NCT02478944|"~     Aims: Prospective evaluation of patients with a suspicion or diagnosis of Inflammatory bowel~     disease (IBD) to evaluate osophageal motility before and during therapy~      Material and methods: The investigators prospectively perform manometry in patients with or~     with symptoms consistent with IBD. The investigators evaluate esophageal motility with high~     resolution manometry before, during and after IBD therapy. Clinical data are also collected~     to find possible correlations. The study do not modify the planned IBD therapy, but observe~     motility findings.~   "
83188|NCT02478099|"~     To be able to evaluate the investigational imaging - 89Zr-MPDL3280A-PET and 18F-FB-IL2-PET -~     as complementary tools for selection of patients to be treated with MPDL3280A, within this~     treatment trial the investigators will assess safety, tolerability and anti-tumor activity of~     MPDL3280A in cancer patients, who have undergone investigational imaging.~   "
83486|NCT02474186|"~     1. To induce immunity-mediated tumor response outside the radiation field (abscopal effect)~          after chemo-radiation of a metastatic site in metastatic breast cancer patients.~        2. To monitor the induction of a T cell response.~        3. To explore the role of PET scanning to assess tumor responses/abscopal effect.~   "
83124|NCT02478931|"~     The purpose of this study is to learn more about personalized cancer therapy including~     response to treatment and side effects. Information about the tests and treatments a person~     received, or will receive, for their cancer will be collected from medical records to help~     the researchers determine whether or not patients respond better when their physicians choose~     to treat them according to the genetic makeup of their tumor. Optional research tests may be~     performed on tissue, body cavity fluid, blood or urine provided, discarded biological samples~     taken during routine care that would normally be disposed of and not saved, or on blood~     samples collected for this study. These research tests will be used to create a profile of~     the collected specimens which will describe unique characteristics about the genes involved~     in a person's cancer. The tests will also help researchers look for biomarkers that may help~     predict how people respond to treatment.~   "
83125|NCT02478918|"~     This is a quality improvement study to determine the impact of an automated telephone~     reminder on the quality of bowel preparation in patients undergoing outpatient colonoscopy.~   "
83126|NCT02478905|"~     The epidemiology and transmission dynamics of influenza in hospitals are only poorly~     understood, particularly with respect to subjects without symptoms of influenza infection~     (e.g. without fever, cough, sore throat, nasal congestion, weakness, headache, loss of~     appetite, or myalgia). Knowledge about whether asymptomatic subjects are able to transmit~     influenza is of major importance. If they do transmit influenza, vaccination of patients and~     healthcare workers (HCW) before start of the influenza season, the permanent use of masks by~     HCW during influenza season, and quarantine for previously exposed inpatients may be the only~     available measures to reduce the number of influenza transmission events from asymptomatic~     subjects in acute care hospitals. Closure of this knowledge gap would be of major benefit to~     infection prevention and control recommendations, and may in turn reduce morbidity and~     mortality associated with influenza in hospitals through improved patient management.~   "
83127|NCT02478892|"~     The study is a prospective, observational, case-control study evaluating the utility of~     endoscopic ultrasound for the identification of preneoplastic and neoplastic pancreatic~     lesions in patients at high risk for pancreatic cancer, specifically those with BRCA1/2~     mutations.~   "
83128|NCT02478879|"~     The purpose of this study is to determine which of two delivery methods of Parathyroid~     Hormone (PTH) is preferred by patients after 14 days of use for each.~   "
83129|NCT02478866|"~     BPI-9016M is a novel, highly potent and selective small-molecule inhibitor of c-Met/Axl~     kinase. In preclinical studies, it demonstrated strong activity in vitro and in vivo against~     c-Met/Axl kinase and its downstream signaling targets, and inhibited tumor cell growth. This~     first-in-human study is conducted to assess the maximum tolerated dose (MTD) and~     dose-limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary~     anti-tumor activity of BPI-9016M with single doses and multiple doses.~   "
83130|NCT02478853|"~     The prevention and control of lifestyle-related non-communicable chronic diseases, including~     diabetes, obesity and cardiovascular disorders, that share common risk factors, has now~     become a major focus of the World Health Organization. Lifestyle modification, like~     improvement of diet, physical activity and tobacco cessation, is the corner stone of diabetes~     and cardio-metabolic chronic diseases (CMCD) prevention and management. Under the leadership~     of decision-makers of our regional health Agency in order to improve accessibility and~     quality of care, our team has collaborated to the development and implementation of an~     integrated care framework for the prevention and management of cardio-metabolic chronic~     diseases in primary care. This new care framework is currently being implemented in the~     context of community health centers (fall 2014) and family medicine groups (spring 2015),~     with the support of a Quebec Ministry of Health grant. The current research proposal aims to~     evaluate the implementation of this new care framework and explore its impact in the primary~     care context. This project is very important as it will generate knowledge on new models of~     care integrating preventive and management interventions in primary care settings, in~     continuum with specialized health care services and their implementation in an entire region.~   "
83131|NCT02478840|"~     The overall objective is to evaluate the long-term efficacy of Lamazym i.v. treatment in~     patients with alpha-Mannosidosis previously enrolled in Lamazym trials and currently~     receiving the treatment according to the AfterCare Program.~   "
83132|NCT02478827|"~     Schizophrenia is associated with a wide range of symptoms impacting a number of different~     domains, including cognitive impairment. Given the array of cognitive deficits associated~     with schizophrenia and their relationship to daily functioning, numerous research groups have~     examined the impact of cognitive remediation on many aspects of cognition. However, it is~     currently unclear as to which domains of cognition should be targeted to produce the most~     widespread and durable benefits for schizophrenia patients. It may be the case that targeting~     lower-level cognitive processes that are important for higher-level and more complex aspects~     of cognition may produce the most widespread benefits in cognition and everyday functioning.~     Relatively few studies have examined the effects of working memory or processing speed~     training on individuals with schizophrenia, as most studies examine broad-based remediation~     programs. Thus, there is a need for targeted working memory and processing speed training~     studies to better understand the mechanisms of cognitive enhancement through training in~     patients. This study will aim to: 1) investigate near-transfer gains associated with working~     memory and processing speed training in schizophrenia patients, 2) investigate far-transfer~     gains associated with working memory and processing speed training (i.e., gains in other~     neurocognitive domains and social cognition), and 3) investigate real-world gains associated~     with training (i.e., gains in daily functioning). Towards this aim, 81 schizophrenia patients~     will be recruited and randomly assigned to a working memory training group, a processing~     speed training group, or a no training control group. Training will be completed at home for~     30 minutes per day, 5 days per week, for a total of 10 weeks. Neurocognitive, social~     cognitive, and daily functioning measures will be administered both pre- and post-training to~     detect training-related gains.~   "
83133|NCT02478814|"~     Protein requirements in active individuals have been suggested to be greater than the current~     recommended dietary allowance (RDA).~      Nutritional requirements for dietary amino acids in adults have traditionally been determined~     utilizing the nitrogen balance technique, which is prone to underestimating protein~     requirements. As a result, there is a need to re-evaluate recommendations in order to~     characterize how dietary amino acid needs may be modulated by physical activity.~      Recent studies using the minimally invasive indicator amino acid oxidation (IAAO) technique~     have suggested that protein requirements in young men are at least 50% higher than the RDA~     based on nitrogen balance data.~      The purpose of this study is to measure the protein requirement in active, young adult males~     using the IAAO technique in the presence of a variable intensity exercise stimulus.~   "
83407|NCT02475252|"~     In a prospective case-control study, the investigators compare the Objective Structured~     Assessment of Technical Skills (OSATS) scores in medical students and gynecologic experts~     performing a hysteroscopy on a training model for diagnostic hysteroscopy. The investigators~     hypothesize that OSATS on a hysteroscopy training model has construct validity to~     discriminate between experts and novices.~   "
83134|NCT02478801|"~     Protein requirements in individuals who participate in endurance-based exercise training have~     been suggested to be greater than the current recommended dietary allowance (RDA).~      Nutritional requirements for dietary amino acids in adults have traditionally been determined~     utilizing the nitrogen balance technique, which is prone to underestimating protein~     requirements. As a result, there is a need to re-evaluate recommendations in order to~     characterize how dietary amino acid needs may be modulated by physical activity.~      Recent studies using the minimally invasive indicator amino acid oxidation (IAAO) technique~     have suggested that protein requirements in young men are at least 50% higher than RDA based~     on nitrogen balance data.~      Therefore, the purpose of this study is to measure the protein requirement in endurance~     trained adults using the IAAO technique.~   "
83135|NCT02478788|"~     The main purpose of this study is to see the affects of the study medication called mixed~     amphetamine salts-extended release (MAS-XR) on brain function by taking brain pictures. The~     researchers also want to see if MAS-XR makes your child more or less likely to develop~     problems like acting out (i.e. periods of irritability, agitation, aggression).~      MAS-XR is approved by the United States Food and Drug Administration (FDA) to treat attention~     deficit hyperactivity disorder (ADHD) in adults, children and adolescents.~   "
83136|NCT02478775|"~     Excess maternal weight, especially obesity, influences almost every aspect of fertility, from~     conception to problems during pregnancy. The investigators will use novel statistical methods~     to clarify the hormonal changes behind reproductive health conditions. A better understanding~     of reproductive hormonal changes in obese women may offer a way to identify new treatments.~   "
83137|NCT02478762|"~     In a previous study, the investigators established the dosage of foetal glycated hemoglobin~     (FGH). It represents the mean of blood sugar 4-6 before the delivery. The investigators also~     compared the FGH of newborn of women with and without gestational diabetes mellitus (GDM) and~     determined that newborn of women with GDM had significantly higher FGH that newborn of women~     without GDM.~      In this study, the investigators want to compare the FGH of newborn of GDM women randomized~     to a group reaching the Canadian Diabetes Association recommended blood glucose objectives~     treatment (fasting: 5.3 mmol/L and 2-hour after meals: 6.7 mmol/L) to a group reaching lower~     blood glucose objectives (fasting: 4.8 mmol/L and 2-hour after meals: 5.9 mmol/L)~   "
83138|NCT02478749|"~     The purpose of this study is to determine the effect of arm retraction on the supraclavicular~     approach for subclavian vein catheterization in adults and children.~   "
83139|NCT02478736|"~     Postoperative delirium is an important problem in patients undergoing major cardiac surgery~     and associated with more complicated hospital course, increased hospital length of stay and~     total postoperative cost. A study shows that a low preoperative cerebral oximetry (rSO2) is~     associated with postoperative delirium after on-pump cardiac surgery. Another study showed~     that patients who underwent cardiac surgery with reduced cerebral blood flow (CBF) velocity~     in the left middle cerebral artery (MCA) preoperatively are at greater risk for postoperative~     cognitive dysfunction (POCD). Therefore, the investigators hypothesize that lower~     perioperative rSO2 and reduced preoperative mean flow velocity (MFV) of MCA are good~     predictors of the postoperative delirium in the patients undergoing the on-pump cardiac~     surgery.~   "
83140|NCT02478723|"~     A post market, observational study evaluating the treatment of 1st and 2nd molars indicated~     for root canal therapy and treated with the Sonendo GentleWave System and obturated with~     CPoint and BC Sealer in at least one canal.~   "
83141|NCT02478710|"~     The purpose of this study is to determine if administering inhaled antibiotics directly into~     the lungs in conjunction with intravenous (IV) antibiotics leads to better outcomes and~     decreased recurrence of ventilator associated pneumonia (VAP) when compared to IV antibiotics~     alone.~   "
83142|NCT02478697|"~     Previous findings indicate elevated risk for tobacco use among adults in California who are~     unemployed and seeking work. In a pilot study, tobacco use was associated with a longer~     duration of time out of work. This community-based participatory research study aims to~     deliver and evaluate the impact of a web-based job seeker tailored tobacco cessation~     intervention vs. a control group in the San Francisco Bay Area. This research investigates~     whether an employment-centered tobacco treatment intervention is efficacious in supporting~     abstinence and also associated with more timely engagement of employment.~   "
83143|NCT02478684|"~     Delayed cord clamping (DCC) from 30 to 60 seconds allows blood to continue to flow from the~     placenta through the umbilical cord to the infant, thus resulting in a placental transfusion.~     This transfusion may improve circulating volume at birth leading to a smoother postnatal~     transition and overall improved outcome for preterm infants. The average blood volume~     delivered with DCC up to 90 seconds in preterm infants has been estimated to be about 12 ml~     per kg with vaginal deliveries resulting in slightly higher transfusions compared to cesarean~     deliveries. Several several short-term benefits have been described including a reduction in~     the need for blood transfusions as well as a possible reduction in intraventricular~     hemorrhage and necrotizing enterocolitis. All mothers with threatened preterm delivery~     between 28 and 34 6/7 weeks will be approached for the study. Following consent, the infant~     will be randomly assigned to either a 30 or 60 second delay in cord clamping in the delivery~     room. If the infant is not breathing by 30 seconds, the cord will be clamped and the infant~     moved to a resuscitation area. The primary outcome is a 3 percent difference in the~     hematocrit at one hour (routinely obtained on all babies). With approximately 75 neonates in~     each group (30 and 60 second DCC), there is 80% power to detect a difference in the mean~     hematocrit of 3% using a two-sample t-test with a 0.05 two-sided significance level.~   "
83144|NCT02478671|"~     Subjects' radial artery diameters and plethysmography waveforms will be recorded by MRI and~     pulse oxymetry at varying levels of radial artery compression by the Terumo TR Band.~   "
83145|NCT02478658|"~     Study the circulatory levels of irisin in response to one session of high-intensity~     resistance training in a group of healthy subjects.~   "
83146|NCT02478645|"~     Many patients receiving opioid based analgesia after gynecologic laparoscopic surgery~     experience postoperative nausea and vomiting (PONV) despite prophylaxis and treatment with~     HT3 receptor antagonists. Although a high dose of ramosetron can cause adverse effects such~     as headache or dizziness, the minimal effective dose of ramosetron in a high-risk patients is~     unknown. The aim of this study is to determine the effective dose of ramosetron for~     prophylaxis of PONV in a high-risk patients receiving intravenous opioid-based~     patient-controlled analgesia after gynecological laparoscopic surgery.~   "
83147|NCT02478632|"~     The purpose of this study is to evaluate any change from baseline in bone mineral density~     (BMD) in subjects following the switch from a triple antiretroviral therapy (ART) regimen~     containing Tenofovir disoproxil fumarate (TDF) to the nucleoside reverse transcriptase~     inhibitor (NRTI) - sparing two - drug regimen of dolutegravir (DTG) + rilpivirine (RPV) in~     subjects participating in the parent studies 201636 and 201637 (SWORD-1 and SWORD-2).~      This open-label, parallel group, study is a sub-study which will recruit subjects who are~     receiving ART regimens which include TDF at the time of randomization to receive treatment in~     one of two identical parent studies 201636 and 201637 (SWORD-1 and SWORD-2). These are Phase~     III, randomised, open-label, multicentre, parallel-group, non-inferiority studies evaluating~     the efficacy, safety, and tolerability of switching to DTG plus RPV from current integrase~     inhibitor (INI)-, non NNRTI-, or protease inhibitor (PI)-based antiretroviral regimen in~     HIV-1-infected adults who are virologically suppressed, having HIV-1 ribonucleic acid (RNA)~     levels <50 copies per millilitre (c/mL). Randomisation in the parent studies will be~     stratified by baseline third agent class (INI, NNRTI, or PI), age group (< or =>50 years old)~     and participation in this Dual energy X-ray absorptiometry (DEXA) sub-study, therefore there~     will also be balance across the treatment arms in this sub-study both overall and with~     respect to baseline third agent class and age at entry.~      The study population will include approximately 75 evaluable subjects recruited from the~     Early Switch DTG + RPV treatment group of the parent studies 201636 and 201637, and~     approximately 75 evaluable subjects from the Late Switch group who continue their current~     antiretroviral therapy (CAR) through to Week 52 across both the 201636 and 201637 (SWORD-1~     and SWORD-2) studies. Subjects participating in study 202094 will have DEXA scans performed~     at Day 1 and at study Weeks 48, 100 and 148 in parallel with the corresponding scheduled~     visits in the parent studies.~   "
83148|NCT02478619|"~     The purpose of this study is to assess the effect of preoperative inspiratory muscle training~     in patients with grade III obesity undergoing bariatric surgery. It will be a double-blind~     randomized controlled clinical trial with volunteers allocated in two groups that will be~     compared according to postoperative evolution (pulmonary complications, lung function,~     strength and endurance of the respiratory muscles and respiratory system resistance).~   "
83149|NCT02478606|"~     This study investigates the influence of two different stretching techniques on the~     flexibility of the muscles that are in the posterior thigh, after a training period.~      The study will last for six weeks where the volunteers need to go to the lab twice for~     evaluation, and for four weeks, three times a week for the application of stretching~     training.~      Evaluation before and after the training period consists of applying hip and knee flexibility~     tests, evaluation of strength, muscle activation and muscle architecture. The Flexibility~     tests are: (1) Straight Leg Raise Flexibility Test (SLR), where the volunteer will be~     positioned supine on a stretcher. Then the appraiser will perform hip flexion keeping the~     knee extended and relaxed foot to the angle at which the person refer discomfort while the~     contralateral limb remain firmly leaning on the table; (2) Modified Passive knee extension~     (TEJ), where the volunteer will be positioned supine on a stretcher. The assessor shall~     determine the hip member to be rated at 90º and perform knee extension to the angle at which~     the person refer discomfort. The contralateral limb remain firmly leaning on the table.~      For the evaluation of muscle strength the volunteer had sat on equipment, makes five~     repetitions of bending and straightening the knee to familiarize yourself with the equipment~     and after will make other five replicates doing maximum strength.~      To evaluate the electrical activity will be the depilation of the skin with a razor and~     cleaning with an alcohol swab after adhesive electrodes will be placed for collection of~     muscle activity, the electrodes do not emit shocks.~      The muscle architecture will be assessed via a ultrasound , to its use the use of a water~     soluble gel to improve the machine's skin contact is required.~      For the intervention, the stretching will be held in both legs, where the volunteer will~     remain lying on a stretcher with fixed trunk with velcro straps and the researcher will carry~     out the elongation raising the leg drawn to the moment of discomfort the volunteer will refer~     and will remain for 30 seconds (s) in case he belongs to passive static stretching group, if~     the stretching group of proprioceptive neuromuscular facilitation, will be in the same~     position, but before the 30s of stretching, he you will have to push against during 6s to~     lower leg against the researcher.~      If he belongs to the control group, have only two trips to the laboratory for testing, will~     make an initial assessment and after four weeks will return to perform the tests again, in~     the period between assessments will not need to go to the lab because it does not make~     intervention elongation.~      It is possible that there discomfort during flexibility testing, strength testing and~     stretching training. After the tests can still experience muscle pain should disappear within~     48 hours. The risks of research are minimal, not exceeding those of a strength training~     session and stretching.~   "
83150|NCT02478593|"~     The overall goal of this research is to develop and test strategies to decrease potentially~     inappropriate medication use among the elderly.~   "
83151|NCT02478580|"~     Obstructive sleep apnea (OSA) and obesity is associated with increased perioperative~     morbidity and mortality. This group of patients is at risk of perioperative desaturations~     which can be worsened by perioperative sedatives and narcotics needed for surgery. OSA~     patients might also need to spend the night in intensive care for more frequent monitoring~     for any desaturations episodes especially if the patient will be requiring multiple~     intravenous narcotic boluses for pain control. Several studies have looked into the most~     appropriate way to manage these patients and some recommendations have been made to avoid~     outpatient surgery with close monitoring for first 24 hours after surgery specifically if~     patient will require intravenous postoperative narcotics.~      Nuvigil (Armodafinil) is a wake promoting agent (Cephalon inc., West Chester, PA) that's FDA~     approved for excessive daytime sleepiness in narcolepsy, shift work sleep disorder, and~     obstructive sleep apnea. The precise mechanism(s) through which armodafinil (R-enantiomer) or~     modafinil (mixture of R- and S-enantiomers) promote wakefulness is unknown.~      Nuvigil is longer acting product which is similar in action to Modafinil however is much~     cheaper. Nuvigil has not been previously studied for postoperative recovery. The~     investigators intend to study the effects of Nuvigil on postoperative recovery time and~     wakefulness in obstructive sleep apnea and obese patients.~   "
83152|NCT02478567|"~     Randomized crossover trial evaluating the impact of exercise training sequence of~     axioscapular and rotator cuff exercises in patients diagnosed with subacromial impingement~     syndrome.~   "
83153|NCT02478554|"~     Fetal growth abnormalities is one of the most common problems faced in modern obstetrics. The~     association between low birth weight and perinatal death as well as severe morbidity is well~     known. Since fetal weight cannot be measured directly, obstetricians use estimates of fetal~     weight obtained by utilizing various ultrasonographic measurements to diagnose growth~     abnormalities. Currently in clinical practice, the majority of fetal ultrasound centers~     employ population-based fetal growth curves that have been previously published and updated~     to estimate fetal weight percentiles. Up to 70% of neonates found to be below the 10%~     percentile for estimated fetal weight in population-based growth curves are actually~     constitutionally small; that is a neonate deemed small based on standardized growth curves~     but in reality have reached its appropriate growth potential in relation to its genetic~     predisposition.~      An equally difficult clinical scenario is fetal macrosomia. A recent meta-analysis revealed~     that the sensitivity and specificity of ultrasound detection of fetal macrosomia ranges from~     15-79%. When compared with neonates with normal birth weight, the odds ratio of emergency~     cesarean delivery and shoulder dystocia are increased significantly.~      Various ultrasound parameters have been tested in an effort to detect both fetal compromise~     prior to the development of permanent damage and allow differentiation between true fetal~     growth abnormalities and normal growth potential. Recent reports have introduced the concept~     of customized fetal growth curve which uses physiological variables to report an adjusted~     fetal growth assessment. To date, the use of customized fetal growth curves has not been~     evaluated prospectively. Furthermore, this strategy has not been compared to standard~     population-based fetal growth curves currently used in clinical practice to determine which~     would be the most ideal for use in clinical practice.~      The primary research question is: are customized fetal growth curves more accurate than~     population-based fetal growth curves at predicting abnormalities in fetal growth, defined as~     small-for-gestational age or large-for-gestational age at birth in newborns of high-risk~     pregnancies? Randomly, participants will be assigned to either having fetal growth reported~     by customized or population bases growth curves.~   "
83204|NCT02477891|"~     The objective of this study is to provide early access to daratumumab treatment and collect~     additional safety data while the medication is not commercially available or available~     through another protocol for subjects with multiple myeloma who have received at least 3~     prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent~     (IMiD) or whose disease is double refractory to both a PI and an IMiD.~   "
83154|NCT02478541|"~     High levels of fatty substances in the blood increase the risk of developing coronary heart~     disease and having a heart attack. The investigators know a lot about one of these fatty~     substances, cholesterol. However, there is another fatty substance in the blood called~     triglyceride. The investigators do not understand much about what regulates the rate at which~     the liver produces triglyceride and liberates it into the bloodstream after eating a meal(s).~     The investigators are developing new techniques to measure these processes in healthy people.~     Ultimately a deeper understanding of the regulation of this process might lead to the~     development of new treatments for fat accumulation in the liver and high blood fat levels and~     related disorders. The present study is an investigation of how these processes relate to~     various bodily characteristics such as thinness and fatness and the distribution of fat in~     the body.~   "
83155|NCT02478528|"~     Sleep disorders are a major public health issue, affecting 1 in 6 French. The medical impact~     at the individual level but also social and economic level (loss of productivity, morbidity,~     mortality) emphasize the need for one hand, to improve the investigators' understanding of~     these disorders in order to develop appropriate therapeutic tools and on the other hand, to~     increase the investigators' support abilities of patients with these disorders.~      The investigators' team of unity sleep from Strasbourg University Hospitals, in collaboration~     with the UPR 3212 CNRS team, is working on the development and adjustment of new concepts and~     tools to compensate the investigators' sleep debt in order to apply them to patients with~     sleep disorders and persons who face with sleep restriction.~   "
83156|NCT02478515|"~     Monthly intravitreal ranibizumab (IVR) during the first 6 month had great effect for macular~     edema with branch retinal vein occlusion (BVO) both in visual and anatomical outcome. It is~     expected that similar results could be obtained by less frequent IVR. The purpose of this~     study is to investigate if IVR by PRN is as effective as by monthly. In addition, the~     investigators are going to study the relationship between macular edema and the size and~     location of retinal non-perfusion area.~   "
83157|NCT02478502|"~     Germ cell tumors belong to the most chemosensitive malignancies. Paclitaxel in combination~     with ifosfamide and cisplatin (TIP) has become a common regimen for salvage treatment of germ~     cell cancer.~      Cabazitaxel may overcome resistance to docetaxel and paclitaxel and might have clinical~     activity in patients with metastatic and progressive germ cell tumors.~   "
83158|NCT02478489|"~     The specific aims of this pragmatic randomized controlled trial are to compare initiating~     injectable extended release naltrexone (XR-NTX) or oral naltrexone (PO-NTX) at the time of~     discharge from a medical hospitalization for patients with alcohol use disorder (AUD) on: 1)~     alcohol consumption and consequences, and 2) acute healthcare utilization (including hospital~     readmission and emergency visits) and cost-effectiveness. In exploratory analyses, the~     investigators will assess moderators of medication effects including demographic, behavioral,~     and genetic factors.~   "
83159|NCT02478476|"~     The presence of single nucleotide polymorphisms (SNPs) in genes involved in platinum and~     taxane metabolism and detoxification have been correlated to increased risk of severe adverse~     events (AEs) when patients receive these drugs. The investigators propose studies to validate~     a comprehensive panel of twelve SNPs in ovarian cancer patients that may predict AEs when~     treated with therapies that include platinum and taxanes. Using these results to stratify~     patients to different dosing regimens, routes of administration, or in recurrent cancer to~     aid in drug selection, may improve outcome and reduce costs for the management of drug~     related side effects while not changing standard of care. Since these differences can be~     detected from blood, the determination of genotypes can be done using a standard blood sample~     taken after ovarian cancer is confirmed on the patient's pathology report. These genetic~     differences can be detected by QPCR and Next Generation Sequencing.~   "
83160|NCT02478463|"~     Cabotegravir (CAB) long-acting (LA) is a promising candidate for human immunodeficiency virus~     (HIV) pre exposure prophylaxis (PrEP) due to its potent antiretroviral activity and~     infrequent dosing requirements. Currently, the CAB concentrations achieved in the anatomical~     sites associated with sexual HIV transmission following the proposed 600 milligram (mg)~     intramuscular (IM) PrEP dose are unknown. These data will enhance our understanding of CAB~     distribution to the anatomical mucosal tissue believed to be relevant to sexual HIV-1~     transmission and supplement the data to support future PrEP clinical trial development. The~     primary objective is to determine the PK concentrations of CAB following LA administration in~     plasma and in vaginal tissue (VT), cervical tissue (CT), and cervicovaginal fluid (CVF) in~     healthy women and in rectal tissue (RT) and rectal fluid (RF) in healthy men and women~     following a single 600 mg IM dose. This will be a Phase 1, open label study in healthy~     subjects to assess the pharmacokinetics of CAB LA in the plasma and mucosal locations~     associated with sexual HIV-1 transmission: VT, CT, CVF, RT and RF. The study will consist of~     a screening period, a 28-day oral lead-in phase at a dose of 30 mg per day followed by a~     14-42 day washout period, and a single dose of CAB LA 600 mg as an IM (intragluteal)~     injection with compartmental pharmacokinetic (PK) sampling for up to 12 weeks. Subjects will~     return for safety assessments and plasma PK sampling at Week 24 and Week 36 post-injection~     and undergo a follow-up/withdrawal visit at Week 52 post-injection.~   "
83161|NCT02478450|"~     This study is a non-randomized, open-label, partially blinded, sequential cohort,~     dose-escalation study designed to obtain preliminary data on the safety, tolerability, and~     early efficacy of Q-Cells® transplantation in subjects with ALS. Following an initial cohort~     receiving cell transplants unilaterally in the lumbar spinal cord, subsequent cohorts will~     receive escalating doses transplanted unilaterally in cervical spinal cord. Subjects and~     outcome measure assessors will be blinded to side of treatment. The study will be conducted~     at sites with extensive clinical experience with the care of patients with ALS.~   "
83162|NCT02478437|"~     This study is being done to determine whether cooled radiofrequency ablation (CRFA) on the~     medial branch nerves of the lumbar facet joint is effective for the treatment of low back~     pain. CRFA blocks the nerves that carry pain signals from joints in the lower back such that~     the brain does not receive the message that the low back is in pain. This technique is~     commonly performed by burning these nerves rather freezing them, but it is suspected that~     freezing them results in better pain relief. The CRFA blocks has been shown to effectively~     treat sacroiliac joint pain (a joint in the pelvis), which is another reason that it is~     suspected that CRFA will be effective when treating pain related to facet joints in the low~     back. We are performing this study in order to determine if that is the case.~   "
83163|NCT02478424|"~     Cannabidiol (CBD), a non-psychotropic ingredient of Cannabis sativa possesses potent~     anti-inflammatory and immunosuppressive properties. In a recent prospective phase II study~     (NCT01385124) 48 consecutive adult patients undergoing allogeneic hematopoietic cell~     transplantation were given CBD 300 mg/day starting 7 days before transplantation until day~     30, on top of standard GVHD prophylaxis consisting of cyclosporine and a short course of~     methotrexate. There were no grade 3-4 toxicities attributed to CBD. None of the patients~     developed acute GVHD while consuming CBD. With a median follow-up of 16 months, the~     cumulative incidence rates of grade 2-4 and grade 3-4 acute GVHD by day 100 were 12.1% and~     5%, respectively. Compared to 101 historical control subjects given standard GVHD~     prophylaxis, the hazard ratio of developing grade 2-4 acute GVHD among subjects treated with~     CBD plus standard GVHD prophylaxis was 0.3 (p=0.0002). Among patients surviving more than 100~     days, the cumulative incidence of moderate-to-severe chronic GVHD at 12 and 18 months were~     20% and 33%, respectively.~      The aim of this study is to explore the safety and efficacy of extended use of CBD until day~     100 in the prevention of acute and chronic GVHD.~   "
83164|NCT02478411|"~     Study designed to evaluate the functional and motor effects in critically ill subjects at ICU~     and hospital discharge with the incorporation of a mobilization program of cycloergometric~     physiotherapy sessions compared with conventional physiotherapy.~   "
83165|NCT02478398|"~     The purpose of this study is to assess the efficacy and safety of MK-3641 (short ragweed~     [Ambrosia artemisiifolia] extract, MK-3641, SCH 039641, RAGWITEK™) sublingual immunotherapy~     tablets in children aged 5 to 17 years with ragweed-induced allergic~     rhinitis/rhinoconjunctivitis with or without asthma. The primary hypothesis of this study is~     that administration of MK-3641 sublingual immunotherapy tablets to children 5 to 17 years of~     age, compared with placebo, will result in a significant reduction in rhinoconjunctivitis~     symptoms and medication use over the peak ragweed season (RS).~   "
83166|NCT02478385|"~     The main purpose of this study is to explore the impact of the birth environment on women's~     birth experience and relevant birth outcomes in the experimental Labour room compared to a~     standard Labour room.~   "
83167|NCT02478372|"~     The purpose of this study was to determine if the method of peri-operative analgesia used~     following total Knee Replacement surgery affected the progress towards rehabilitation goals~     and to determine whether the analgesia had any impact on long term outcomes.~   "
83168|NCT02478359|"~     Chronic obstructive pulmonary disease (COPD) is the third leading cause of the death in the~     US. The personal, social and economic costs of the disease are tremendous, with annual~     expenditures of nearly $50 billion, mostly from hospitalizations for exacerbations of COPD~     and associated sequelae. For the vast majority of patients, despite optimal pharmacological~     therapy, living with COPD is characterized by unrelieved dyspnea, physical inactivity,~     deconditioning, and an insidious downward spiral of social isolation and depression that has~     a profound impact on the lives of patients and their caregivers. There is mounting evidence~     that physical inactivity is significantly associated with more frequent hospitalizations and~     increased mortality in COPD even after adjusting for disease severity.~      While practice guidelines recommend regular physical activity for all patients with COPD,~     health systems are challenged in operationalizing an effective and sustainable approach to~     assist patients in being physically active. The investigators propose a pragmatic randomized~     controlled trial to determine the effectiveness of a 12-month physical activity coaching~     intervention (Walk On!) compared to standard care for 1,650 COPD patients from a large~     integrated health care system.~   "
83169|NCT02478346|"~     This study focuses on implementing Yellow 560 for the direct intraoperative visualization of~     Fluorescein Sodium stained intracranial lesions to facilitate extend of surgery, develop~     better treatment protocols, and improve the prognosis of a wide array of neurosurgical~     diseases. More specifically, for the patients who are undergoing surgical intervention for~     the treatment of their brain aneurysm, tumor, arteriovenous malformation or fistula, the~     investigators will inject the dye intraoperatively to assess for residual aneurysm, tumor or~     in general residual lesion which must be corrected.~   "
83170|NCT02478333|"~     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of~     ALS-008176 following oral administration of single ascending dose of ALS-008176 in healthy~     Japanese adult participants.~   "
83171|NCT02478320|"~     The goal of this clinical research study is to learn if ilorasertib (ABT-348) can help to~     control CDKN2A-deficient cancer. CDKN2A deficiency is a type of mutation (a genetic change).~     The safety of this drug will also be studied.~   "
83172|NCT02478307|"~     Up to 80% of Australians experience back pain and 10% have significant disability as a~     result. There is a critical need for the development and evaluation of innovative treatments~     that have the capacity to target the multidimensional nature of chronic low back pain. This~     study will compare the effects and mechanisms of Mindfulness Meditation, Cognitive Therapy,~     and Mindfulness-Based Cognitive Therapy for chronic low back pain. Results will ultimately~     lead to streamlined interventions designed to efficiently maximise benefit.~   "
83173|NCT02478294|"~     This cohort study aims to evaluate thoracoscopic left atrial appendage excision plus atrial~     fibrillation ablation versus oral anticoagulants for the prevention of stroke and non-central~     nervous systemic embolism in patients with atrial fibrillation and thromboembolism.~   "
83174|NCT02478281|"~     A Phase 1 trial to assess the single-dose safety, tolerability, and pharmacokinetic (PK) of~     Methylene Blue Injection, USP 1 mg/kg in healthy adult voluneetrs.~   "
83187|NCT02478112|"~     The benefit of dose escalation in radiotherapy (RT) for biochemical control of prostate~     cancer is a clearly established fact based on the results of different published prospective~     trials. This benefit, acquired with three-dimensional conformal radiation technique is~     counterbalanced by an increase in urinary and gastrointestinal toxicity. The joint progress~     of dose planning systems and multileaf collimators (MLC) technology have enabled the~     Intensity Modulated Radiation Therapy (IMRT). Recently the contribution of spacers~     positioned in the septum between the rectum and the prostate could improve the functional~     results of IMRT in terms of rectal toxicity.~      The aim of the investigators study is to assess the dosimetric gain from the contribution of~     the implantable BioProtect balloon on organs at risk.~   "
83505|NCT02473939|"~     The purpose of the study is to Evaluate the safety, tolerability, pharmacodynamics and~     pharmacokinetics of single inhaled doses of VR942 in healthy subjects (part 1) and repeated~     doses in mild asthmatics (part 2).~   "
83175|NCT02478268|"~     The purpose of this study is to determine whether magnetic resonance imaging (MRI) using~     inhaled hyperpolarized 129Xe gas, and conventional contrast can help visualize impaired lung~     function and detect changes over time in patients receiving treatment as well as those who~     don't. 129Xe is a special type of xenon gas and when inhaled during MRI may be able to show~     areas of abnormal thickening of parts of the lungs. These images combined with images taken~     with injected contrast agents or other types of MRI may provide a better way to look at lung~     structure and function in patients with IPF. The ultimate goal is to predict how a particular~     patient might respond to a particular therapy and to observe such responses earlier than~     conventional tests. The investigators anticipate that the images acquired in this study will~     provide more specific information about lung disease than standard lung function tests. The~     use of 129Xe MRI is investigational. Investigational means that these tests have not yet~     been approved by the US Food and Drug Administration and are being tested in research studies~     like this one. In addition, standard MRI with contrast is not typically done as standard of~     care for monitoring progression of IPF, therefore, its use in this study is also considered~     investigational.~      Healthy volunteers are being asked to participate in this study because the investigators~     need to develop a database of functional images that are representative of healthy lungs.~   "
83176|NCT02478255|"~     The purpose of this study is to determine whether magnetic resonance imaging (MRI) using~     inhaled hyper polarized xenon-129 (129Xe) gas, and conventional contrast can help visualize~     impaired lung function and detect changes over time in patients receiving treatment as well~     as those who don't. 129Xe is a special type of xenon gas and when inhaled during MRI may be~     able to show areas of abnormal thickening of parts of the lungs. These images combined with~     images taken with injected contrast agents or other special types of MRI such as conventional~     proton (1H) MRI may provide a better way to look at lung structure and function. The ultimate~     goal is to predict the degree of radiation-induced lung injury that will develop in a given~     patient for a given treatment plan. The investigators anticipate that these images will~     provide more specific information about lung disease than standard lung function tests. The~     use of 129Xe MRI is investigational. Investigational means that these tests have not yet been~     approved by the US Food and Drug Administration and are only available in research studies~     like this one. In addition, standard MRI with contrast is not typically done as standard of~     care for monitoring changes due to thoracic radiation therapy, therefore, its use in this~     study is also considered investigational.~      Healthy volunteers are being asked to participate in this study because to develop a database~     of functional images that are representative of healthy lungs.~   "
83177|NCT02478242|"~     Randomized study to evaluate the efficacy and safety of nafamostat mesilate use during~     continuous renal replacement therapy in acute kidney injury patients at a high risk of~     bleeding.~   "
83178|NCT02478229|"~     The study is a single centre, single arm, open-label, proof of concept study enrolling 20~     adult primary liver transplant recipients with genotype 1 HCV infection. Subjects will~     receive Sofosbuvir (SOF) and Ledipasvir (LDV) starting at time of liver transplantation (OLT)~     and continues for 12 weeks. Subjects will be receive 24 week post-treatment follow up.~   "
83179|NCT02478216|"~     The patients were allocated randomly to receive remote preconditioning group (RIPC group, R)~     or not (Control group, C) using sealed envelopes with the options inside the sealed envelope~     of R and C before anaesthesia induction. The registered nurse who did not participate in~     patient care and was blind to the study performed the all randomization process. All medical~     staffs who involved the patient care were blind to the study. All data were collected by~     trained observers who were blind to the study and did not participate in patient care~   "
83180|NCT02478203|"~     After Local Human Research Ethics Committee approval, emergency medical staff enrolled in~     this study. After watching a video about the intubation using Airtraq, Glidescope or direct~     laryngoscopy, they attempted to intubate a pediatric manikin in three different airway~     models.~   "
83181|NCT02478190|"~     Emergency Department (ED) patients with severe hyperglycemia will be randomized to two~     treatment goals: discharge glucose less than 600 mg/dL or less than 350 mg/dL.~      Randomization is stratified by whether the chief complaint is High Blood Sugar in the~     electronic medical record or other.~   "
83182|NCT02478177|"~     The Addressing Real-world Anticoagulant Management Issues in Stroke (ARAMIS) registry is~     designed to provide important and timely insight into the management of acute stroke patients~     who are on novel oral anticoagulants in community practice.~   "
83183|NCT02478164|"~     This research study is studying a chemotherapy as a possible treatment for recurrent~     glioblastoma that has not responded to bevacizumab. The name of the study drug involved in~     this study is Ponatinib.~   "
83184|NCT02478151|"~     This trial will examine the safety and feasibility of using the OrganOx Metra device to~     transport and store donor livers under normothermic conditions prior to transplantation.~     Participants will be followed for 3 months following transplantation and their outcomes~     recorded.~   "
83185|NCT02478138|"~     Cervical lymph node involvement, in head and cancer neck patients, is one of the most~     important prognostic factors. Currently patients undergo neck dissection removing some or all~     nodes and neck involvement is retrospectively determined. Sentinel lymph node (SLN)~     identification and biopsy has become clinical practise in other areas including breast, skin,~     and gastric cancer. The gold standard for detecting metastatic lymph nodes is pathological~     analysis, but the lack of an accurate or clinically accepted way to identify sentinel lymph~     nodes in the cervical region has motivated the usage of indocyanine green (ICG) and~     near-infrared fluorescence (NIR) imaging (Pinpoint, Novadaq, Waterloo). A prospective~     clinical trial using a commercially available NIR system and ICG injection around the tumour~     site will evaluate the ability to detect and biopsy sentinel lymph nodes in head and neck~     cancer patients.~   "
83186|NCT02478125|"~     Hypothesis: Treatment with Burixafor hydrobromide will effectively mobilize metastatic~     prostate cancer (PCa) cells (i.e. disseminated tumor cells; DTCs) into the blood from the~     bone marrow. It has been demonstrated that prostate cancer cells have been mobilized out of~     the bone marrow of mice utilizing an anti-CXCR4 strategy; making them more susceptible to~     chemotherapy.~   "
83506|NCT02473926|"~     This study plans to learn more about physical activity and physical function in sedentary~     older adults with type 2 diabetes.~   "
83189|NCT02478086|"~     Introduction:~      The preterm newborn of extremely low birth weight (PNELW), endures adverse nutritional~     conditions to mimic intrauterine growth. It´s known that amino acids contribute to protein~     synthesis, but also intervene in weight gain. Most newborns receive amino acids throw~     parenteral nutrition at a doses of 3.5gr/k/day, that doses its unable to reach the birth~     weight when discharged, so the weight its below the 10th percentile, which rises the risk for~     presenting alterations in neurodevelopment.~      Objective:~      To compare a higher doses of parenteral amino acids vs. standard doses, expecting an~     increased weight gain in the high amino acid doses group, meanwhile following the renal~     function security profile~      Methods:~      A randomize, single blind clinical trial, carried on, in the Neonatology Service of Unidad~     Medica de Alta Especialidad Numero 48 of the Instituto Mexicano del Seguro Social, in the~     city of Leon, Mexico. Between the period of 1st August 2012 to 31 January 2013. A standard~     doses of amino acids was administered (3.5gr) to a control group and a high doses (4gr) to an~     experimental group. Weight, urea, creatinine and blood urea nitrogen (BUN) were measured~     weekly. In the study were included all preterm newborns (PN) weighting less than 1500 grs and~     with less than 32 weeks of gestational age that match all the inclusion criteria. Statics~     Analysis: descriptive statistics were calculates, also chi2 test and Fisher Exact test were~     applied to categorical variables, t-student test to continuous variables, and ANOVA in~     multiple groups.~   "
83190|NCT02478073|"~     Antibiotic dosing in critically ill patients poses a challenge for clinicians due to the~     pharmacokinetic changes seen in this population. Piperacillin/tazobactam is often used for~     empirical treatment, and initial appropriate dosing is crucial for reducing mortality.~      Patients in the Intensive Care Unit (ICU), treated with piperacillin/tazobactam, had their~     plasma concentration of piperacillin determined 1-3 times weekly. Patients received~     piperacillin as intermittent bolus infusion 3 times daily or as continuous infusion (this was~     up to the treating physician). Time above the minimal inhibitory concentration (T>MIC)~     estimated for each patient was evaluated against clinical breakpoint MIC for Pseudomonas~     aeruginosa (16 mg/L). Pharmacokinetic-pharmacodynamic (PK-PD) targets evaluated were 100% f~     T>MIC (free piperacillin concentration maintained above the MIC throughout the dosing~     interval) and 50% fT>4xMIC (free piperacillin concentration maintained at a level fourfold~     the MIC for at least 50% of the dosing interval).~   "
83191|NCT02478060|"~     The purpose of this study is to evaluate the safety and tolerability of multiple~     administrations of Birch-SPIRE. To make a preliminary assessment on pharmacodynamic~     parameters and clinical outcomes.~   "
83192|NCT02478047|"~     The purpose of this study is to clarify whether distal-proximal point association is more~     effective than partial match point association by electro-acupuncture in the management of~     chemotherapy-induced nausea and vomiting .~   "
83193|NCT02478034|"~     In this study the effects of mineralocorticoid stimulation on social cognition will be~     investigated in healthy young individuals.~   "
83194|NCT02478021|"~     The effects of hydrocortisone on cognition will be investigated.~   "
83195|NCT02478008|"~     The purpose of the study is to evaluate the initial short and long-term safety and~     performance of the CardiAQ™ Transcatheter Mitral Valve Implantation System using the~     Transapical Delivery System.~      The study will enroll patients with moderate to severe mitral valve regurgitation who are~     considered high or extreme risk for mortality and morbidity from conventional open heart~     surgery.~   "
83196|NCT02477995|"~     Pertussis, diphtheria and tetanus are seriously infectious diseases in children. Since using~     of the adsorption diphtheria-tetanus-whole-cell pertussis (DTwP), it greatly reduced~     incidence of the three kinds of diseases. But the thallus of pertussis in the vaccine may~     cause more side reactions after vaccination. Since 2000, the basic immunization DTwP vaccine~     has been replaced by adsorption tetanus-diphtheria-acellular pertussis vaccine in American.~     In 1995, DTaP was successfully developed in China, and have been used in EPI at present.~     Because of effective immunity and little side reaction, DTaP has been widely recognized and~     accepted by the parents.~   "
83197|NCT02477982|"~     The primary objective of this study is to develop a descriptive and predictive~     pharmacokinetics model propofol disposition during cardiopulmonary bypass (CPB) in obese and~     lean patients.~   "
83198|NCT02477969|"~     This is a multicenter, randomized, double-blind, placebo-controlled, phase III clinical study~     that will enroll approximately 564 T2DM patients who before screening have inadequately~     controlled blood glucose （7.0%≤HbA1c≤10.5% at randomization）despite at least 8 weeks of~     metformin monotherapy at stable doses（≥1500 mg/day).~   "
83199|NCT02477956|"~     Bariatric surgery patients tend to have malabsorption of many micronutrients such as B12,~     Iron and vitamin D postoperative. So in this study, a monthly high dose of vitamin D3 is~     giving to patients with their routine supplements and followed up for 6 months.~      Hypothesis:Bariatric surgery subjects taking monthly high dose cholecalciferol supplements in~     addition to the standard vitamin D protocol will have a significant rise in serum vitamin D~     levels compared to the subjects taking only the usual vitamin D protocol.~   "
83200|NCT02477943|"~     This study is designed to collect data which will be used to correlate changes in EEG to mild~     TBI in sports concussion.~   "
83201|NCT02477930|"~     The purpose of this registry is to collect data on the clinical use of endoluminal vacuum~     (E-Vac) therapy to treat both upper and lower intestinal leaks and perforations.~   "
83202|NCT02477917|"~     The study was designed according to the draft of allergenic product regulation published by~     Spanish Regulatory Agency. The aim of the study is to evaluate the safety and tolerability of~     subcutaneous immunotherapy with Parietaria judaica pollen extract in patients with~     rhinoconjunctivitis with or without associated mild asthma. In addition, surrogate efficacy~     parameters will be evaluated: immunoglobulin level changes and skin reactivity.~   "
83203|NCT02477904|"~     This study will assess the effectiveness of the ketogenic diet (high-fat, low-carbohydrate,~     and moderate protein) in treating autism spectrum disorder (ASD). Three study groups will be~     comprised of children (2-21 years of age) based on whether or not they have ASD and receive~     the ketogenic diet - ASD/ketogenic diet, ASD/non-ketogenic diet, and non-ASD/non-ketogenic~     diet.~   "
83760|NCT02470624|"~     This is a multi-center registry study. The investigators will include 10,000 patients with~     confirmed acute ischemic stroke in China. The aim of the study is to survey current treatment~     situation in China and compare the effectiveness and safety between different intervention~     regimens.~   "
83205|NCT02477878|"~     A Phase I study of BPX-501 T cell infusion in adults with recurrent or minimal residual~     disease (MRD) hematologic malignancies post-allogeneic transplant. The treatment consists of~     increasing doses of BPX-501 T cell infusions to achieve a clinical response. AP1903 will be~     investigated for the treatment of aGvHD after BPX-501 T cell infusion to determine a dose~     that can mitigate GvHD and preserve the graft-versus tumor effect.~   "
83206|NCT02477865|"~     This is a phase III, multicenter, randomized, double-blind, placebo-controlled study planning~     to include approximately 387 T2DM patients who have received at least 8 weeks of treatment~     with diet control and exercise； have not received any glucose-lowering agents within the 8~     weeks prior to screening; and have inadequately controlled blood glucose.The subjects would~     receive PEX168 or placebo monotherapy for 52weeks in total.~   "
83207|NCT02477852|"~     The purpose of this study is to determine the better preoperative anti-tuberculosis treatment~     period of patients with spinal tuberculosis.~   "
83208|NCT02477839|"~     The purpose of this trial is to assess the effectiveness and the safety of Lacosamide~     administered as add-on therapy with 1 to 3 anti-seizure medications. This trial is for~     children aged 1 month to less than 4 years with epilepsy who currently have uncontrolled~     partial-onset seizures.~   "
83209|NCT02477826|"~     The purpose of this study is to show that Nivolumab, or Nivolumab plus Ipilimumab, or~     Nivolumab plus Platinum-Doublet Chemotherapy improves progression free survival and/or~     overall survival compared with chemotherapy in patients with advanced lung cancer.~   "
83210|NCT02477813|"~     It is a single-arm, open label clinical trial. Patients affected by relapsed or refractory~     small-cell lung cancer patients with MGMT promoter methylation are included in this study;~     they will be treated with oral Temozolomide 200 mg/m2 die for 5 consecutive days every 28~     days. Treatment will be continued until tumor progression, intolerable toxicity or patient~     refusal.~      A Minimax Simon 2-stage design will be used. - First stage: 9 patients If 1 or less responses~     will be observed, the trial will be ended.- Second stage: other 10 patients (for a total of~     19 subjects enrolled) If 5 or less responses will be observed in 19 patients, the treatment~     will not be considered active, while if 6 or more responses will be observed, the treatment~     will be considered sufficiently active to warrant further testing. Since the rate of~     methylation ranges from 20 to 48% the number of patients to be screened should be between 40~     and 95.~      The primary objective is to determine the overall response rate [ORR = CR + PR]; the~     secondary objectives are to determine the time to Progression (TTP), the overall Survival~     (OS), the toxicity and the correlation between response Rate (RR) and the level of MGMT~     promoter methylation and/or base excision repair (BER) genes alterations.~   "
83211|NCT02477800|"~     The primary objective of the study is to evaluate the efficacy of monthly doses of aducanumab~     in slowing cognitive and functional impairment as measured by changes in the Clinical~     Dementia Rating-Sum of Boxes (CDR-SB) score as compared with placebo in participants with~     early AD. Secondary objectives are to assess the effect of monthly doses of aducanumab as~     compared with placebo on clinical progression as measured by Mini-Mental State Examination~     (MMSE), AD Assessment Scale-Cognitive Subscale (13 items) [ADAS-Cog 13], and AD Cooperative~     Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version)~     [ADCS-ADL-MCI].~   "
83212|NCT02477787|"~     This is a single center, open label, random comparison phase 2b study. The primary objective~     of this study is, by random comparison, to assess the anti-leukemia effect of allogeneic,~     donor-derived natural killer (NK) cells infused after HLA-haploidentical hematopoietic cell~     transplantation (HCT) in patients with refractory acute myelogenous leukemia (AML).~      The secondary objectives of the study are to assess the side effects of donor NK cell~     infusion, effects of donor NK cell infusion upon HCT outcomes, as well as effects upon~     post-HCT immune recovery.~   "
83213|NCT02477774|"~     This is a single-blinded multi-institutional randomized controlled trial to evaluate the~     effectiveness of Arista hemostatic matrix powder (Arista® AH, C. R. Bard, Inc. Davol,~     Warwick, RI) in reducing drainage output in anterolateral thigh (ALT) free flap donor sites.~     Increased drainage from donor sites can lead to seroma formation with possible secondary~     infection, delayed hospital discharge, and additional home care needs for drain care. Arista~     is an inert plant based absorbable surgical hemostatic powder that can be easily applied to~     broad surgical fields to reduce bleeding and seroma rates. Therefore, its application to free~     flap donor sites may bear significant potential benefit.~      Specific Aim 1: The main hypothesis of the study is that the use of Arista in anterolateral~     thigh (ALT) free flap donor sites prior to closure will reduce postoperative drain outputs~     and time to drain removal compared to ALT donor sites closed without Arista.~      Specific Aim 2: This study will also evaluate the secondary hypotheses that Arista will~     reduce postoperative ALT donor site seromas and patient hospital length of stay.~   "
83214|NCT02477761|"~     The investigators aimed at evaluating the effects of a small non-glucidic nutrient preload on~     plasma glucose, insulin, C-peptide, glucagon-like peptide-1, and glucose-dependent~     insulinotropic polypeptide concentrations after the meal consumption and for 300 min after a~     75 g glucose ingestion in diet-controlled type 2 diabetic patients.~   "
83215|NCT02477748|"~     This study is a multi-center, randomized, double-blind, placebo-controlled, phase 3 study of~     MDX (1400 mg daily) for 10 weeks compared with placebo in adults with ADHD.~      The study will be comprised of Screening, Washout (if required), Treatment (total of 10~     weeks) and Follow-up periods. Approximately 750 patients will be enrolled and undergo initial~     eligibility assessments.~   "
83216|NCT02477735|"~     The purpose of this study is to investigate the prevalence of sleep disturbances in children~     with Chronic Otitis Media with Effusion (COME) and the effect of tympanostomy tube insertion~     (TTI) on sleep disturbances.~   "
83257|NCT02477202|"~     Combination-type oral contraceptives (COCs) have been shown to significantly reduce the risk~     of invasive epithelial ovarian cancer (IEOC); this protective effect may be achieved to a~     large extent through COCs ability to reduce cell proliferation in the fallopian tube fimbriae~     (FTF). The progestin-releasing Mirena® intra-uterine device (IUD) is an increasingly popular~     method of contraception, but it is not known if its use will reduce a woman's risk of IEOC.~     Mirena® use does not block ovulation in most women but it may release sufficient progestin to~     also reduce cell proliferation in the FTF. This study aims to evaluate the effects of the~     Mirena® IUD on cell proliferation in the FTF as a possible biomarker of protection against~     IEOC.~   "
83217|NCT02477722|"~     Exposure to life threatening, traumatic and stress inducing events in general is an~     inevitable part of military combat service . Among individuals exposed to a traumatic event,~     approximately 85-90 % will develop a stress response from which they will recover without~     need for any medical intervention whatsoever. However, roughly 10-15 % will continue to~     suffer from post-traumatic symptoms along with depression or anxiety disorders1, . The~     prominent symptoms of post - traumatic stress disorder (PTSD), consists of reliving the event~     via invasive and painful memories that include: images, thoughts or feelings, night terrors,~     and extreme emotional distress that arise when exposure to external or internal cues similar~     to or symbolizing aspects of the traumatic event. Following this distress, behavioral~     avoidance of situations that trigger unpleasant memories may develop. Such mental stress may~     lead to avoidance of social situations and hinder normal daily functioning in a variety of~     contexts2. The question arises as to what distinguishes between those who are exposed to a~     traumatic event and recover spontaneously and those who fail to resume daily life and develop~     PTSD. Attempts to find personality and environmental risk factors for the development of PTSD~     have yet to yield any unequivocal conclusions. This has lead the scientific community to look~     for neuro-physical risk factors as well . Furthermore, evidence that early diagnosis and~     treatment of the disorder helps reduce the severity of post-trauma symptoms -stresses the~     need for the accurate localization of neurological risk factors and new immediate and/or~     preventative interventions. The aim of the present project is to develop a brain oriented~     training method for early preventive interventions of PTSD.~   "
83218|NCT02477709|"~     This study assesses the tolerability of a single dose of gefapixant (AF-219) in participants~     with idiopathic pulmonary fibrosis (IPF). Six eligible participants will receive a single 150~     mg dose of gefapixant and undergo tolerability and PK assessments.~   "
83219|NCT02477696|"~     This study is designed to evaluate PFS endpoint for acalabrutinib vs ibrutinib in previously~     treated chronic lymphocytic leukemia.~   "
83220|NCT02477683|"~     The purpose of this study is to collect data to support decisions made by BioFire regarding~     assay development, panel composition, and intended use for the final FilmArray FI reagent~     pouch. The study will utilize whole blood and/or plasma obtained from pediatric patients~     under 3 years of age that present with acute fever.~   "
83221|NCT02477670|"~     The objectives of this 12-week study are to evaluate the efficacy, safety, and tolerability~     of AVP-786 as an adjunctive treatment compared with placebo in patients with residual~     schizophrenia.~   "
83222|NCT02477657|"~     Malignant ascites leads to significant morbidity in patients with terminal cancer.~     Paracentesis can provide relief, but repeat hospital visits, pain, and short duration of~     relief after paracentesis are detrimental to quality of life(QOL). Two devices are available~     as alternatives to paracentesis. The impact of either device on QOL has not fully been~     explored. A pilot nonrandomized trial measuring palliative care QOL and ascites symptom~     relief using validated survey instruments is proposed.~   "
83223|NCT02477644|"~     Randomized, Double-Blind, Phase III Trial of Olaparib vs. Placebo in Patients with Advanced~     FIGO Stage IIIB - IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or Peritoneal~     Cancer treated with standard First-Line Treatment, Combining Platinum-Taxane Chemotherapy and~     Bevacizumab Concurrent with Chemotherapy and in Maintenance.~   "
83224|NCT02477631|"~     The effect oral iron chelator Deferiprone on the Oxidative stress and on Iron Overload status~     in transfusion dependent, iron-overloaded low risk MDS patients;~      Primary Objective:~      • To evaluate the effect of Deferiprone on oxidative stress parameter - Reactive oxygen~     species (ROS).~      Secondary Objectives:~        -  To evaluate the effect of Deferiprone on other oxidative stress parameters~             1. Reduced glutathione~             2. Membrane lipid peroxidation~             3. External phosphatidylserine~        -  To evaluate the change from baseline to last visit in parameters of iron load.~             1. Serum ferritin (despite ongoing RBC transfusions during the study period).~             2. LIP~             3. LPI~             4. serum hepcidin~        -  To evaluate the change from one month preceding baseline visit to last month on study in~          transfusion requirements.~        -  To monitor safety measures:~             1. Adverse events (AEs).~             2. Number of discontinuations due to AEs~      Study design:~      Single-arm, open-label, multi-center study in 20 iron-overloaded patients with low risk MDS.~     All participants will be treated with deferiprone for up to 4 months. Patients will have~     complete blood count monitored weekly, and will visit the site monthly for assessments of~     safety and efficacy.~   "
83225|NCT02477618|"~     This is a randomized, double-blind, placebo-controlled trial, designed to evaluate the~     efficacy and safety of SAGE-547 administered as a continuous intravenous infusion to subjects~     in Super-Refractory Status Epilepticus (SRSE).~   "
83226|NCT02477605|"~     The purpose of this study is to compare the treatment day change between immediate~     postoperative and immediate preoperative intraocular pressure (IOP) between 27-gauge and~     23-gauge vitrectomy instruments.~   "
83227|NCT02477592|"~     The purpose of this study is to compare effectiveness of two substrate modification~     approaches in long-standing persistent atrial fibrillation patients, and hypothesized that a~     substrate-based, individualized substrate modification (ISM)approach should be superior to~     traditional stepwise ablation(SA). To the best of investigator's knowledge, this was the~     first study to evaluate the real substrate by means of electro-anatomic mapping and to~     perform true substrate modification in long standing persistent atrial fibrillation~     ablation(LPAF).~   "
83228|NCT02477579|"~     This study evaluates the safety and effectiveness of the a novel device called NovaCross to~     help cross Chronic Total Occlusion (CTO) lesions in coronary arteries.~   "
83229|NCT02477566|"~     To test whether long-acting Triptorelin on pituitary down-regulation can improve the clinical~     pregnancy rate and reduces the incidence of ovarian hyperstimulation syndrome (OHSS) in~     infertile high-risk patients with polycystic ovaries (PCOs) who underwent in vitro~     fertilization (IVF) or Intracytoplasmic sperm injection~   "
83258|NCT02477189|"~     This is a retrospective evaluation of all subjects who successfully received implantation of~     the Silicone Block for correction of soft tissue deformities of the penis. In addition,~     subjects will be sent a questionnaire to complete that will evaluate the subject's ongoing~     satisfaction with the implant and any adverse events that may not have been reported to the~     physician.~   "
83230|NCT02477553|"~     Experts believe that increasing the low uptake of screening for colorectal cancer (CRC)~     requires educating patients about all approved tests and helping them choose one that fits~     their preferences. As one motto puts it: The best test is the one that gets done. Screening~     tests range from more invasive and very sensitive for polyps and cancer (colonoscopy) to less~     invasive and less sensitive (e.g., fecal immunochemical testing (FIT)). But it is unclear how~     best to educate patients about the options and the tradeoffs involved. Some guidelines~     recommend that decision aids, a promising tool in this area, provide patients with detailed~     quantitative information, including baseline risk, risk reduction, and chance of negative~     outcomes. But this sort of comparative effectiveness data can confuse patients, especially~     those with limited mathematical ability. Previous studies have not measured the effect of~     providing quantitative information to patients with varying levels of ability or interest or~     asked them whether such data is essential for their decision-making.~      The investigators will conduct a clinical trial to determine the impact on patients who view~     a decision aid (DA) that includes quantitative information versus a DA without such data. The~     investigators will also seek to determine whether numeracy moderates the effect of~     quantitative information.~   "
83231|NCT02477540|"~     This clinical trial to study the Safety and Efficacy of Autologous Mesenchymal stem cells in~     critical limb ischemia.~   "
83232|NCT02477527|"~     Switch patients from Atripla to Stribild will be evaluated to see if patients have less sleep~     disturbances.~   "
83233|NCT02477514|"~     The purpose of this study is to assess the effect of steady-state tedizolid phosphate on the~     single-dose pharmacokinetics of midazolam and rosuvastatin in healthy, adult participants.~   "
83234|NCT02477501|"~     The purpose of the study is to determine if norepinephrine is more effective as a continuous~     intravenous (IV) infusion compared to continuous IV ephedrine associated with crystalloid~     loading for maintaining blood pressure during a spinal anesthetic for a cesarean delivery.~     Prevention of low blood pressure has been shown to decrease nausea and vomiting during and~     after cesarean delivery under spinal anesthesia. For elective cesarean delivery, all~     participants will receive spinal anesthesia with a local anesthetic and morphine. This study~     plans to enroll 120 pregnant women. Patients will be randomly assigned according to a~     computer generated system to be in one of two groups.~   "
83235|NCT02477488|"~     Gout has a strong association with the metabolic syndrome, and it is often seen in patients~     with renal insufficiency. Allopurinol is a medication intended to lower uric acid and~     therefore prevents gout attacks. Its metabolism is mainly renal, and some evidence shows that~     it is also dialyzable. The hypothesis is that allopurinol would be more efficacious to lower~     uric acid if it was given after dialysis only. The investigators will then switch~     administration of allopurinol to bedtime for dialysis patients currently taking that~     medication.~   "
83236|NCT02477475|"~     The objective of this investigation is to collect following data in patients given NEXIUM~     capsule (NEXIUM) in usual post-marketing use.~   "
83237|NCT02477462|"~     Primary biliary cirrhosis (PBC) is a progressive autoimmune disease of biliary epithelial~     cells resulting in biliary cirrhosis. PBC is characterized by a 90% female predominance, high~     titers of serum anti-mitochondrial autoantibodies (AMA) directed against the pyruvate~     dehydrogenase complex E2 subunit and evidence from both human and murine models suggests that~     T-cells, particularly cluster of differentiation (CD) 8+ T cells, are key to the destruction~     of bile ducts. However, clinical trials of classic immunosuppressive drugs including~     corticosteroids, azathioprine, methotrexate, and tacrolimus have been largely unsuccessful in~     altering the disease course. This is a single center, prospective, non-treatment study of the~     role of immune responses in PBC patients.~      Non-alcoholic fatty liver disease (NAFLD) and its more severe form, non-alcoholic~     steatohepatitis (NASH) are common, often silent liver diseases. NASH resembles alcoholic~     liver disease, but occurs in people who drink little or no alcohol. The major feature in NASH~     is fat in the liver, along with inflammation and fibrosis. NASH can be severe and can lead to~     cirrhosis and hepatocellular carcinoma. Ten to 20 percent of American have NAFLD with NASH~     affecting 2 to 5 percent of Americans.~   "
83238|NCT02477449|"~     Phase 1 study to investigate safety of istaroxime in healthy chinese volunteers.~   "
83239|NCT02477436|"~     This is an exploratory clinical study to presume the optimum usage and dosage for a~     therapeutic confirmatory study by evaluating the efficacy and safety of Avanafil 50mg, 100mg,~     200mg or placebo administered orally in patients with erectile dysfunction. In conclusions,~     Patients with erectile dysfunction (ED) were administered placebo, Avanafil 50mg, 100mg or~     200mg 30 minutes before sexual intercourse for 8 weeks.~   "
83240|NCT02477423|"~     The purpose of this study is to determine whether antibiotics given immediately after birth~     alter the development of the developing preterm infant's microbiome, which may further alter~     overall clinical outcomes.~   "
83241|NCT02477410|"~     The purpose of the study is to obtain a better understanding of how hydrolysed porcine~     proteins affect the human metabolism, including the effects on muscle protein synthesis,~     appetite and secretion of gastrointestinal hormones.~      It is hypothesised that hydrolysed porcine proteins will stimulate muscle protein synthesis,~     affect appetite and the secretion of gastrointestinal hormones similar to hydrolysed whey~     protein.~   "
83242|NCT02477397|"~     Study to investigate the effects of symptom-driven maintenance and reliever therapy in COPD.~   "
83243|NCT02477384|"~     The aim of this study was to conduct a prospective randomized trial to compare TIPS with 8mm~     expanded polytetrafluoroethylene(ePTFE)-covered stents and endoscopic variceal ligation plus~     propranolol for the prevention of recurrent esophageal variceal bleeding.~   "
83244|NCT02477371|"~     The FARGO trial is a prospective, randomized (1:1), multicenter study. The aim of the study~     is to assess the importance of fractional flow reserve (FFR) assessment prior to coronary~     artery bypass grafting (CABG) with respect to planning and guiding the revascularization~     strategy. The study compares an FFR-guided strategy to an angiography-guided strategy in~     patients planned for surgical revascularization.~   "
83259|NCT02477176|"~     The purpose of this 12-month, prospective, multicenter study is to investigate the effect of~     annular defect size and other risk factors on reherniation and associated costs in primary~     lumbar discectomy patients.~   "
83260|NCT02477163|"~     The purpose of this study is to determine the effect of multi-dimentional ayurvedic treatment~     in the patients of various types of chronic kidney disease.~   "
83245|NCT02477358|"~     In cases of permanent tooth avulsion, it is widely accepted that some necrosis always occurs~     after avulsion injury. If the pulp tissue does not revascularize or if endodontic therapy is~     not performed, the pulp space can become infected. Platelet rich fibrin (PRF) is a second~     generation platelet concentrate that allows the clinician to obtain fibrin membranes enriched~     with platelets and growth factors from an anticoagulant-free blood harvest. Clinical~     relevance of PRF and revascularization has been demonstrated in several case studies of~     avulsion. To date no human clinical trials have been performed evaluating the effectiveness~     of PRF on pulpal revascularization after reimplantation and its benefits in limiting~     inflammation. The following study consists of two phases: Phase 1: An in vitro model~     evaluating the effects of PRF in limiting inflammatory response of pdl cell cultures in the~     presence of an inflammatory mediators. Phase 2: An in vivo model utilizing mature teeth~     previously treatment planned for extraction, treating with PRF, reimplanting teeth and~     following for three to four months before extracting and performing histological analysis. If~     PRF is capable of promoting revascularization in mature teeth the potential benefits extend~     to limiting the need for endodontic therapy following mature tooth avulsion, potential for~     mature tooth transplantation in situations of congenitally missing teeth, and utilization of~     PRF in endodontic revascularization therapy.~   "
83246|NCT02477345|"~     This protocol involves the compassionate use of intravenous fish oil infusion, Omegaven. The~     protocol involves infants and children with parenteral nutrition-associated liver disease to~     enable the reversal of elevated serum liver enzymes and direct bilirubin (cholestasis).~   "
83247|NCT02477332|"~     This is a placebo and active-controlled phase 2b dose-finding study to evaluate efficacy and~     safety of QGE031 monthly subcutaneous injections as add-on therapy in patients with Chronic~     Spontaneous Urticaria.~   "
83248|NCT02477319|"~     identify and validate biomarkers that might reflect partial restoration of CFTR function and~     can be used to monitor disease progression, and ii) evaluate the mechanistic effects of CFTR~     modulators and other relevant therapies in individuals with CF~   "
83249|NCT02477306|"~     Comparative randomized, single dose, two-way crossover open-label study to determine the~     bioequivalence of Rabeprazole from Idiazole 20mg DR tabs (GSK, Egypt)and PARIET 20 mg DR tabs~     (JANSSEN, EGYPT) after a single oral dose administration of each to healthy adults under~     fasting conditions.~   "
83250|NCT02477293|"~     The purpose of this study is to evaluate the safety and effectiveness of~     Hyeonggaeyeongyo-Tang for chronic rhinitis according to pattern identification in Korean~     medicine.~   "
83251|NCT02477280|"~     Aim: The purpose of the study is to examine the effects of medication, placebo and~     expectation on objective and self-rated performance of ADHD core signs during the Quantified~     Behavior Test in patients with untreated ADHD and substance Use Disorders.~      Subjects: Participants are 40 consecutive patients remitted to a neuropsychiatric~     investigation at the Dependence Clinic Västmanland, Västerås, Sweden.~      Method: The study is a double-blind, randomized, placebo-controlled, cross-over study. The~     study is taken place during four hours on two investigating days, separated by a 4 days~     wash-out period.~      All patients participate on two occasions: In one session they receive the Methylphenidate~     (MPH) condition, and in the other session they receive the placebo condition. MPH and placebo~     conditions are counterbalanced across subjects such that half of the participants receive MPH~     first, and half receive placebo first. Neither the patient nor the research assistant is~     aware when the participant receive the MPH condition or the placebo condition.~      On each investigating day the participant accomplish Questionnaires (Visual Analogical~     Scales) concerning; (a) expectation, (b) self-rated performance, (c) exhausting exercise, (d)~     perceived help from the pill and (e) self-rated symptoms. In addition the participant~     completed A Quick Test of Cognitive Speed (AQT) and two separate Quantified Behavior Test~     Plus (QbTest) without medication vs MPH/Placebo. QbTest aims to provide objective information~     regarding core-symptoms of ADHD; hyperactivity on the basis of motor-activity measured with~     the camera, and inattention and impulsivity on basis of the CPT-test.~   "
83252|NCT02477267|"~     The primary objective of this study is to compare the bioavailability of a test formulation~     of Buprenorphine Naloxone Sublingual (SL) spray to that of a single dose of Suboxone®~     (buprenorphine and naloxone) sublingual film, under fasted conditions.~   "
83253|NCT02477254|"~     To study the 5-year immunogenicity against a quadrivalent HPV vaccine in patients with SLE~     and healthy controls.~   "
83254|NCT02477241|"~     Overactive Bladder syndrome (OAB) is a medical condition with symptoms of urgency, with or~     without incontinence, usually with frequency and nocturia, with no proven infection or~     obvious pathology 1. This study will explore the relationship between OAB, obstruction and~     the micro contractions as well as the brain areas involved in both normal desire to void and~     urgency, gaining a better understanding of the bladder pathophysiology and in the future~     allowing better strategy of treatment options for patients suffering from OAB.~   "
83255|NCT02477228|"~     Endoscopic sphincterotomy is now an established method for removal of common bile duct~     calculi and treatment of papillary stenosis, the sump syndrome and certain cases of ampullary~     carcinoma. It is also generally performed prior to biliary stent placement .Anatomical~     variations, papillary stenosis, impacted stones, ampullary tumors, duodenal diverticula, and~     post-gastrojejunostomy states are some of the reasons behind difficult common bile duct (CBD)~     cannulations . In these situations, the success of CBD cannulation can be enhanced slightly~     by using the various accessories designed for this purpose.The aim of this study is to~     prospectively compare conventional approach and needle knife fistulotomy in cannulation of~     ampulla of Vater during endoscopic retrograde cholangiopancreatography regarding~     procedure-related complications as failure of cannulations, bleeding and perforation and~     postoperative complication~   "
83256|NCT02477215|"~     This Phase I/II study is designed to first identify doses of MLN9708 and bendamustine that~     are associated with an acceptable adverse event profile when delivered together in 28-day~     cycles. Additionally, the study aims to assess the efficacy of the combination in patients~     with relapsed/refractory multiple myeloma. Responders (stable disease or more), will continue~     to receive up to eight cycles total in the absence of further progressive disease.~   "
83261|NCT02477150|"~     To study the safety and immunogenicity of a herpes zoster vaccine in patients with SLE.~   "
83262|NCT02477137|"~     The purpose of this study is to evaluate the effects of an interactive ICT-platform for use~     in a smartphone or tablet in patients treated with radiotherapy for prostate cancer. The~     hypothesis is that clinical management will be improved and costs reduced and safe and~     participatory care promoted, when patients report symptoms in an application which provides~     self-care advice and instant access to professionals.~   "
83263|NCT02477124|"~     The purpose of this study is to see if the transvaginal colposcope produces similar results~     to colposcopy for the screening of cervical cancer. In this study the investigators are using~     an investigational device called the transvaginal colposcope. The word investigational means~     that the device is still being tested in research studies and is not approved by the U.S.~     Food and Drug Administration (FDA).~   "
83264|NCT02477111|"~     INSIGHT is a postmarket clinical follow-up study in the European Union. The purpose of the~     study is to continue to evaluate the safety and effectiveness/performance of Incraft in~     subjects with abdominal aortic aneurysms requiring endovascular repair in routine clinical~     practice. Approximately 150 subjects will be enrolled and followed through 5-years~     postprocedure. Up to 25 sites in Europe may participate.~   "
83265|NCT02477098|"~     Rectus sheath block (RSB) is used for postoperative pain relief in patients undergoing~     abdominal surgery with a midline incision. It has proved to be effective in preoperative~     block, but it has not been previously compared with postoperative block. The aim of the~     present study is to evaluate postoperative pain, sleep quality and changes in the cytokine~     levels of patients undergoing gynaecological surgery with RSB performed preoperatively versus~     postoperatively.~   "
83266|NCT02477085|"~     Since it is a frequent intervention in Obstetrics, labor induction is rarely evaluated from~     national population-based cohorts. The study aims to assess the frequency of different~     induction methods used in France from a prospective population-based cohort of women with an~     induced labor. Maternal, fetal and neonatal outcomes will be compared between the different~     induction methods. Moreover the adhesion to national clinical guidelines concerning the~     induction of labor will be studied from this population-based cohort.~      Finally the women satisfaction will be assessed according to the induction method used.~   "
83267|NCT02477072|"~     Hypothesis: Optimal anticoagulation defined as an Activated Clotting Time (ACT) of 300 to 350~     seconds obtained by weight-adjusted doses of unfractionated heparin (UFH) will improve the~     hemostatic environment downstream from the vascular clamp, provide better blood flow in the~     distal bed following peripheral revascularization surgery.~      Objectives: This study is designed to assess the effects of an optimized regimen of UFH on~     the hemostatic environment downstream from the vascular clamp in major vascular surgery.~   "
83268|NCT02477059|"~     Hand osteoarthritis (HOA) which affects the interphalangeal joints and the~     metacarpophalangeal of the thumb is a common disease, the prevalence of which being about 30~     % of the population over than 70. Some forms of HOA are refractory to usual treatments~     (analgesics, NSAIDs, local injections) and can lead to a high disability. In vitro and in~     vivo studies showed that IL-6 is involved in the OA process. The aim of the present study is~     to assess the efficacy of an Interleukin-6-Receptor Inhibitor (tocilizumab) on pain and~     function in patients with refractory hand OA.~   "
83269|NCT02477046|"~     The Strategic Advisory Group of Experts on Immunization (SAGE) has set a plan to replace~     trivalent oral polio vaccine (tOPV) with bivalent OPV (bOPV) plus inactivated polio vaccine~     (IPV) in routine immunization globally, to be instituted in 2015-2016. At the community~     level, the impact of the change from tOPV + IPV to bOPV + IPV on Sabin virus fecal-oral~     transmission (duration of circulation, degree of genetic reversion) and the persistence of~     environmental contamination are unknown. Also unknown is the impact of the change from tOPV~     to bOPV on community circulation of Sabin 2 after a special immunization (SI) activity with~     monovalent oral poliovirus type 2 (mOPV2). Finally it is unknown at the level of an~     individual child if type 2 fecal shedding will be limited by cross-protection from oral~     vaccination with Sabin type 1 and 3.~      The investigators propose to measure at a community level transmission of Sabin 2 virus in~     Bangladesh, a low income country, where fecal-oral transmission and environmental exposures~     are high, comparing transmission in the setting of vaccination with tOPV+IPV vs. bOPV+IPV.~     The study will be conducted in 67 villages in Matlab, Bangladesh, using a cluster-randomized~     study design. Villages in Matlab will be randomly assigned to receive as part of routine~     immunization (RI) activities: (1) tOPV (6,10,14 weeks) plus IPV at 14 weeks; (2) bOPV (6,10,~     14 weeks) plus IPV at 14 weeks; or (3) bOPV (6,10, 14 weeks) plus IPV at 14 and 18 weeks.~     Community and environmental surveillance for Sabin 2 virus will be conducted in each village~     over the 9 month period of these RI activities. In addition, a SI activity with mOPV2 will~     occur 9 months into the study to model an outbreak response. For the 6 months following the~     mOPV2 challenge, the impact of the different vaccination regimens on Sabin 2 transmission in~     the community will be determined, as well as individual level protection (as measured by~     fecal shedding from days 7-70 after mOPV2 challenge).~   "
83270|NCT02477033|"~     During this project the safety, tolerability and effect on gut microbiota of oral~     administration of Butyricicoccus pullicaecorum was investigated in healthy human volunteers~     by a placebo-controlled cross-over randomized study.~   "
83271|NCT02477020|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of TAK-063~     compared with placebo in treatment of acutely exacerbated schizophrenia.~   "
83272|NCT02477007|"~     The main objective of this study is to evaluate the efficacy of two drugs: paracetamol and~     ibuprofen in association with morphine, compared with morphine alone on analgesia in children~     seen in the emergency department for a long-bone fracture and also to study the potential~     synergic effect of the association paracetamol and ibuprofen.~   "
83273|NCT02476994|"~     This will be a descriptive study designed to evaluate the propensity for hospitalized~     pediatric patients treated adequately with Clinolipid or standard of care for up to 90 days~     to develop Essential Fatty Acid Deficiency (EFAD). Additionally, this study design will~     evaluate the safety and efficacy of using Clinolipid in a pediatric population.~   "
83274|NCT02476981|"~     This randomised, double-blind study compared remifentanil and dexmedetomidine for monitored~     anaesthesia care (MAC) during minimally invasive corrections of vertebral compression~     fracture (vertebroplasty (VP) and kyphoplasty (KP)).~      In total, 80 ASA physical status I-III patients scheduled for VP and KP randomly received~     remifentanil or dexmedetomidine to maintain OAA/S scale ≤ 4 during the procedures. Multiple~     hemodynamic variables of patients were recorded and the frequency of oxygen desaturation,~     respiratory depression, intraoperative need for other opioids, recovery time, operator~     satisfaction score, and patients' overall pain experiences were also compared.~      The investigators are expecting that both remifentanil and dexmedetomidine appear to be quite~     safe for MAC during VP and KP. Thus, dexmedetomidine may be an alternative for MAC during VP~     and KP in elderly patients.~   "
83286|NCT02476825|"~     This is a randomized, single-blind, controlled, single centre bronchoscopy study designed to~     assess the effects of fluticasone propionate on airway gene expression and cellularity in~     healthy adult controls without asthma.~   "
83275|NCT02476968|"~     This is a prospective, open-label, single arm, multi-center study to assess the real world~     clinical effectiveness and safety of olaparib maintenance monotherapy as the capsule~     formulation (in line with the EU approved prescribing information) and will be conducted in~     platinum-sensitive relapsed high grade epithelial ovarian cancer patients (including patients~     with primary peritoneal and / or fallopian tube cancer) who carry germline or somatic BRCA~     mutations (documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or~     suspected deleterious [known or predicted to be detrimental/lead to loss of function]).~   "
83276|NCT02476955|"~     An Open-label Phase 1b Study of ARQ 092 in Combination with Carboplatin Plus Paclitaxel, in~     Combination with Paclitaxel, or in Combination with Anastrozole in Subjects with Selected~     Solid Tumors~   "
83277|NCT02476942|"~     This non-interventional study will prospectively collect detailed, high-quality documentation~     of bleeds, HRQoL, and safety in patients with hemophilia A with or without FVIII inhibitors~     treated according to local routine clinical practice (receiving FVIII replacement or~     bypassing agents as either episodic or prophylactic treatment). Actual patients will be~     enrolled from routine clinical practice in this observational study.~   "
83278|NCT02476929|"~     Introduction: Rhinitis, sinonasal polyposis (SP) and asthma are diseases whose pathogenesis~     is based on inflammation. This will determine the presence of disease, its evolution and its~     treatment. It is therefore very important to develop and validate methodologies that allow us~     to noninvasively detect inflammation of the airways. Thus, just as exhaled nitric oxide~     (FeNO) has been studied as an important non-invasive marker of inflammation of the lower~     airways, nasal nitric oxide (nNO) may be a good marker of nasal inflammation. Furthermore,~     the electronic nose is an electronic nanosensor device capable of detecting specific volatile~     organic compounds (VOCs) that can be used as a non-invasive biomarker of biochemical~     processes in different diseases whose pathophysiology is also based on inflammation.~      Objective: To determine reference values of nNO and different patterns of VOCs in healthy~     individuals, individuals with allergic rhinitis (AR) and non-allergic rhinitis and~     individuals with SP and asthma.~      Methodology: Prospective, controlled study. Four groups will be included: Healthy subjects,~     patients with AR, non-allergic rhinitis and patients with SP and asthma (n=252). Prick-test~     to pneumoallergens will be performed. Determination of FeNO, nNO, lung function tests,~     measurement of VOCs by the electronic nose and blood samples will be taken. Bilateral nasal~     endoscopy and sample collection using the technique of brushing of mucosa and the placement~     of filter papers, for the study of nasal cytology and mediators of inflammation.~   "
83279|NCT02476916|"~     Study AG348-C-003 is a multicenter study designed to evaluate the safety and efficacy of~     different dose levels of AG-348 in patients with PK deficiency.~   "
83280|NCT02476903|"~     Hip arthroscopy is a rapidly evolving procedure that has seen an exponential increase in the~     number of cases performed yearly. With hip arthroscopy still in its infancy in relation to~     knee and shoulder arthroscopy, there are still many questions yet to be answered. Axioms that~     were once thought to be true regarding indications and treatment for hip arthroscopy are~     continually being revised. As with the knee and shoulder before it, the hip is now graduating~     into treatment avenues that were otherwise thought to only be possible through an open~     surgical procedure.~      Viscosupplementation in patients post arthroscopy with known articular cartilage injury has~     been shown to be efficacious. The pathophysiology of hyaline degradation during the arthritic~     process within the knee has been studied, and with this understanding has grown the~     widespread usage of viscosupplementation. While questions still exist regarding the~     effectiveness of viscosupplementation in non-weightbearing joints, it appears the benefits~     seen in the weight bearing joints, such as the knee, are apparent~   "
83281|NCT02476890|"~     The primary objective of this study was to assess the effect of a single dose of gefapixant~     100 mg on cough reflex sensitivity to various challenge agents (capsaicin, citric acid,~     adenosine triphosphate [ATP], and distilled water) in healthy and chronic cough participants.~   "
83282|NCT02476877|"~     The prevalence estimates for specific mental disorders and illicit drugs have been separately~     reported in U.S. government surveys. Less is known about the rates for specific comorbid~     conditions, e.g., schizophrenia and substance abuse, major depression and substance abuse,~     bipolar disorder and substance abuse, and anxiety disorder and substance abuse. The effects~     that different demographic characteristics (ethnic background, family medical history, age,~     living conditions [e.g., living with a single parent]) have on the prevalence of comorbid~     mental illness and substance abuse also have not been considered. More should be known about~     the duration of substance abuse in different mental illnesses among those undergoing~     treatment, and whether specific types of drugs are associated with specific mental illnesses.~      In this study, Advanced Clinical Laboratory Solutions, Inc. will investigate the prevalence~     rates for the specific comorbid conditions and demographic relationships described above.~     This multi-site, proof-of-concept cohort study will analyze urine or oral fluid samples from~     1,000 subjects diagnosed with one of four mental illnesses (schizophrenia, major depression,~     bipolar disorder, or anxiety disorder) as determined by DSM-IV (The Fourth Edition of the~     Diagnostic and Statistical Manual of Mental Disorders). The samples will be analyzed for both~     prescription drug compliance and illicit substance abuse. Urine or oral fluid samples will be~     collected at three time points: 1) immediately after enrollment and obtaining informed~     consent, 2) randomly within 2 to 4 months of the study, and 3) at the end of the study (6~     months).~   "
83283|NCT02476864|"~     A study conducted in healthy adults to investigate if a new macitentan tablet leads to the~     same fate of macitentan in the body (time of onset, time of presence, amount in the blood) as~     the marketed macitentan tablet.~   "
83284|NCT02476851|"~     This study evaluates whether whole blood transferred through the new POLFA needle assembly~     meets supernatant hemoglobin acceptability standards.~   "
83285|NCT02476838|"~     The purpose of this study is to see if an investigational surgery that transfers tissue from~     a non-living donor to living individual will help restore greater function, appearance, and~     sensation to the hand and forearm areas of individuals who have suffered traumatic injury to~     the hand and forearm.~      This procedure is called a hand allotransplantation or hand transplant.~      This study will also collect data on how patients do during and after having a hand~     transplant from a nonliving donor. Recovery and outcomes will be observed through clinical~     exams, x-rays, blood and tissue tests, and other associated evaluations at all follow up~     visits.~   "
83287|NCT02476812|"~     Investigators will conduct a randomized controlled trial of a 30-day positive activities~     intervention, Positive Piggy Bank, compared to a Wait-List control group (Figure 2). Prior to~     their scheduled appointment to undergo epidural steroid injection, all patients meeting study~     criteria will be contacted by research staff to be invited to participate in this study.~     Those interested will be asked to arrive 45 minutes before their regularly scheduled~     appointment. At that time they will learn more about the study and provide informed consent~     if they choose to participate. Participants will then complete the study questionnaires and~     be randomized 1:1 to the Positive Piggy Bank condition (n=100) or the Wait List control group~     (n = 100). All participants will receive the usual treatment provided at the Back & Pain~     Center at the University of Michigan, Department of Anesthesiology (e.g., maintenance of~     medication regimen, standard office visits). Post-intervention (Day 30) and 2 months after~     that (Day 90), participants will complete the same questionnaires by mail. The primary~     outcome will be improved functional status, while secondary outcomes will be symptomatic~     (i.e., pain, fatigue and sleep) and related to mood and well-being. After the study period,~     the patients in the Wait List control will be offered the Positive Piggy Bank intervention~     and will be asked to complete one more set of questionnaires at 30 days by mail.~   "
83288|NCT02476799|"~     Rectus sheath block (RSB) is a kind of anterior abdominal wall block. It has postoperative~     analgesic effect for abdominal surgery with midline incision. Laparoscopic gynecologic~     surgery is accompanied by significant postoperative pain and usually IV-PCA is used to manage~     the pain.The purpose of this study is to investigate the analgesic effect of~     ultrasound-guided RSB to multi-port laparoscopic gynecologic surgery which has incision site~     at umbilical area. Patients will randomly assigned to two groups, RSB group and Control~     group. Each patients will assessed for time to first rescue analgesia, verbal numerical~     rating pain scores, number of rescue analgesic demands, and postoperatively opioids use by~     IV-PCA by a blinded investigator at 0, 1, 6, 12, 24 and 48 hours postoperatively.~   "
83289|NCT02476786|"~     Multiple neoadjuvant endocrine trials demonstrate that women with good prognosis tumors can~     be identified. These trials have also demonstrated that there are not adverse effects on~     overall outcome if women are treated with neoadjuvant endocrine therapy for several months~     prior to definitive treatment. A new standard of care needs to be defined for elderly women~     with good prognosis estrogen receptor (ER)+ tumors, since these women may benefit from~     endocrine therapy alone to treat their cancer without compromising local and distant control.~     The investigators hypothesize that endocrine therapy alone provides adequate local and~     systemic control of breast cancer in a subpopulation of women 70 or older with ER+ breast~     cancer and low Ki67 scores.~   "
83290|NCT02476773|"~     Na-GST-1 and Na-APR-1 are proteins expressed during the adult stage of the Necator americanus~     hookworm life cycle that are thought to play a role in the parasite's degradation of host~     hemoglobin for use as an energy source. Vaccination wtih recombinant GST-1 or APR-1 has~     protected dogs and hamsters from infection in challenge studies. This study will evaluate the~     safety and immunogenicity of co-administering Na-GST-1 and Na-APR-1 to healthy Brazilian~     adults living in an area of endemic hookworm infection.~   "
83291|NCT02476760|"~     The purpose of this study is to determine whether incretin-based drugs (used to treat type 2~     diabetes) taken either alone or in combination with other anti-diabetic drugs are associated~     with an increased risk of acute pancreatitis (AP) compared to other combinations of oral~     hypoglycemic agents (OHA).~      The investigators will carry out separate population based cohort studies using~     administrative health databases in six jurisdictions in Canada, the US, and the UK. Cohorts~     will be defined by the initiation of a new anti-diabetic drug when incretin-based drugs~     entered the market, with follow-up until hospitalization for AP. The results from the~     separate sites will be combined to provide an overall assessment of the risk of AP in users~     of incretin-based drugs and by class of incretin-based drugs.~   "
83292|NCT02476747|"~     The investigators will investigate the efficacy of EMR compared to CSP in treatment of small~     colon polp (6~10mm).~      One aim of this study was to investigate the necessity of EMR on resection of small colon~     polyp.~   "
83293|NCT02476734|"~     In this study the investigators would like to describe FDG-PET/CT responses in patients who~     are receiving CART-19 immunotherapy for Follicular Lymphoma (FL), Diffuse Large B-cell~     Lymphoma (DLBCL), and Mantle Cell Lymphoma (MCL) as part of UPCC #13413. Subjects will~     undergo two FDG-PET/CTs. One performed within 6 weeks of CART-19 infusion and a repeat scan~     at about 1 month after infusion.~   "
83294|NCT02476721|"~     The clinical presentation of acute pulmonary embolism ranges from mild dyspnea and cough to~     shock or sustained hypotension but it also may even be asymptomatic and diagnosed by imaging~     procedures performed for other purposes. (1) Depending on the clinical presentation, the case~     fatality rate for acute pulmonary embolism ranges from 1% up to 60%. Due to the often~     non-specific presentation, especially in mild to moderate acute pulmonary embolism PE is~     often underdiagnosed. Chest pain and shortness of breath are the two most common symptoms~     associated with pulmonary embolism, together these symptoms are responsible for approximately~     10 million emergency department visits in the United States of America (US) (2). The aim of~     this study was to determine the sensitivity and specificity of diagnosing pulmonary embolism~     (PE) at the emergency department (ED) of the University Hospital Basel and the investigators~     have therefore retrospectively analyzed all cases with excluded or proven PE in our~     institution in the last three years. Data sets from the institute of radiology, the institute~     of pathology and the ED are consistently available from January 2011 until the present day~     and were screened for pulmonary embolism in discharge reports. Data from the ED include all~     patients between January 2011 and December 2013 that presented to the ED and received either~     an ECG or any form of thoracic imaging. Particular attention was paid to patients with PE in~     the discharge report. The third set of data includes all patients with PE as cause of death~     or as a secondary diagnosis in the autopsy report. After comparing the three sets of data to~     each other the investigators tried to determine the sensitivity and specificity of PE~     diagnosis at the ED respectively the rate of missed diagnoses. A PE was seen as missed if it~     is detected 24h after the patient presented to the ED or if it was detected at another~     department after the patient was transferred from the ED.~   "
83295|NCT02476708|"~     This is an 8-week randomized, double-blind, placebo-controlled, parallel, fixed-dose pilot~     clinical trial of curcumin for the treatment of cognitive impairment in schizophrenia.The~     primary aim of this pilot trial is to provide an effect size estimate for the efficacy of~     curcumin in improving cognitive functioning in schizophrenia. Secondary goals are to~     determine the effect of curcumin over time on negative and positive symptoms, in association~     with inflammatory markers.~   "
83340|NCT02476123|"~     The purpose of this study is to characterize the safety and tolerability and determine the~     maximum tolerated dose (MTD) or the recommended fixed dose of the combinations of~     Mogamulizumab and Nivolumab in subjects with locally advanced or metastatic solid tumors.~   "
83296|NCT02476695|"~     This prospective and multicenter study is to determine the diagnostic performance (accuracy,~     specificity and sensitivity) of transient elastography (FibroTouch) for liver fibrosis~     assessment in chronic hepatitis B (CHB) patients using ROC analysis, and liver biopsy as the~     reference.~      Approximately 600 patients will be enrolled to guarantee 500 final statistical cases; and~     ≥100 cases are required for fibrosis stage S0/1, S2, S3 and S4 (compensatory stage of~     cirrhosis), respectively. For each stage, the case is assigned as equally as possible.~   "
83297|NCT02476682|"~     The purpose of this study is to determine the clinical utility of stool and blood methylation~     tests for detection of advanced mucosal neoplasia (AMN) and sessile serrated polyps (SSP).~   "
83298|NCT02476669|"~     Nasopharyngeal carcinoma (NPC) is an endemic malignancy in Southern China, Hong Kong, Taiwan,~     Singapore and Malaysia. It is highly associated with Epstein-Barr virus (EBV). Radiation~     therapy alone is indicated for early stage I to II diseases while concurrent chemoradiation~     is required for more advanced stage III to IVB diseases. Intensity-modulated radiation~     therapy (IMRT) is the standard radiation technique for NPC, in virtue of its superior target~     coverage and dose sparing to adjacent critical organs-at-risks.~      Plasma EBV DNA and other novel plasma biomarkers have been extensively investigated in NPC.~     Previous studies have proven their predictive and prognostic values in NPC diagnosis,~     surveillance and survival outcomes.~      We would like to investigate the roles of plasma biomarkers including plasma EBV DNA on~     treatment response evaluation, survival and prognosis on NPC, in the modern era of precision~     radiation therapy. This will provide important information on refining on the current edition~     of AJCC/UICC staging classification.~   "
83299|NCT02476656|"~     Objective of study is to explore expression of stress-related genes and inflammation in~     placentas and umbilical cord blood for women participating in group prenatal care compared~     with women receiving individual prenatal care.~   "
83300|NCT02476643|"~     This study aims to test, if a two-week integrative therapy in an internal medicine ward will~     improve symptoms, disability and quality of life in patients with inflammatory bowel disease~     or irritable bowel syndrome.a It shall further be tested, if those changes are associated~     with attitudes and experiences towards complementary and alternative medicine, anxiety,~     depression and stress perception as well as body awareness and responsiveness.~   "
83301|NCT02476630|"~     Oxygen concentration for patients undergoing cardiac catheterization and during admission to~     an intensive care unit is important outcome measure for clinical care. Currently, the tool~     used to monitor the oxygen concentration is a central venous access positioned in the~     superior vena cava or in the pulmonary artery to monitor the central venous oxygen saturation~     (ScvO2). However, it is invasive and not always possible due to a lack of a central line~     access. In this research study, the investigator would like use a noninvasive means for the~     ScvO2 by using the thenar tissue oxygen concentration (StO2). The primary aim for the study~     is to determine if the thenar StO2 correlates with ScvO2 and can serve as a noninvasive~     surrogate for ScvO2.~   "
83302|NCT02476617|"~     A study to evaluate immune restoration following removal of viral antigen in non-cirrhotic~     hepatitis C virus (HCV) genotype (GT) 1a treatment-naïve and pegylated-interferon~     (pegIFN)/ribavirin (RBV) treatment-experienced adults receiving treatment with~     ombitasvir/paritaprevir/ritonavir and dasabuvir coadministered with ribavirin (RBV) for 12~     weeks.~   "
83303|NCT02476604|"~     It is widely acknowledged that cardiovascular disease prevention requires intervention as~     early in the human lifespan as practical. A window of opportunity presents in early adulthood~     when students gain independence as young adults attending university. In a three-phase~     investigation, this study will evaluate the behavioral patterns of university students in the~     domains of diet, exercise, stress management, smoking and sleep (phase 1). Informed with~     information from phase 1, a pilot study (phase 2) will test the feasibility of performing an~     intervention in university students consisting of an 8-week period during which the students~     will receive up to six text messages (by phone or iPad) per week, tailored to address the~     behavioral issues that the student has identified as needing improvement and for which the~     student has indicated a desire to make change. Using lessons learned in phase 2, a~     randomized, controlled trial of the 8 week intervention (phase 3) will compare intervention~     subjects with controls for outcomes of behavior change, measures of anthropometric data, and~     serum markers of cardiovascular risk to test the impact of the intervention~   "
83304|NCT02476591|"~     To investigate the effects of the availability of daily patient-related charges on ordering~     patterns of health care ordering providers and cost containment in the Intensive Care Unit~     (ICU) setting.~   "
83305|NCT02476578|"~     The purpose of this study is to determine whether alerting primary care providers by email~     about low values of BMI, HbA1c% or cholesterol will affect treatment and improve overall~     survival and other health indexes of people older than 75 years.~   "
83306|NCT02476565|"~     The investigators plan to conduct a randomized trial comparing the efficacy of intubating the~     tracheal using an Aintree intubation catheter through either the LMA-S or I-gel supraglottic~     devices~   "
83307|NCT02476552|"~     This is an open-label study with 2 parts, plus an extension study following completion of~     Parts 1 or 2, that is being conducted in approximately 12 subjects (6 subjects in Part 1; 6~     subjects in Part 2) with cancer to examine the absorption, metabolism, excretion, and~     absolute bioavailability of niraparib.~   "
83308|NCT02476539|"~     The purposes of this study are to assess the safety, tolerability and pharmacokinetics of~     Hemay022. The secondary purpose of this study is to assess the efficacy of Hemay022 in the~     treatment of HER2-positive advanced breast cancer.~      The study will be conducted in two parts. Part one, trial will be conducted in 18-30 subjects~     to determine safety and tolerability of Hemay022 in patients with HER2-positive advanced~     breast cancer. Part two, approximately 27 additional subjects with HER2-positive advanced~     breast cancer, are included to better define the tolerability and preliminary efficacy of~     Hemay022.~   "
83309|NCT02476526|"~     The purpose of this study is to show that the use of low volume iso-osmolar non-ionic radio~     contrast medium (30 cc) in a thoracic CT Scanning procedure in a selected group of patients~     with chronic kidney disease (CKD) will avoid contrast induced nephropathy (CIN) in comparison~     to a similar group of patients with CKD who receive no contrast medium..~   "
83310|NCT02476513|"~     In this study,the investigators will evaluate participants that have clinical features~     associated with an increased risk of esophageal disorders.The investigators will also see if~     there is a positive association of esophageal disorders in men,40-60 with or without~     abdominal obesity in the diagnosis of the following diseases; Gastroesophageal reflux~     disease, Barrett Esophagus and Esophageal Adenocarcinoma. The investigators hypothesize that~     most obese patients referred for Esophagogastroduodenoscopy will exhibit esophageal~     disorders. Since currently the rates of obesity and adenocarcinoma of the esophagus have~     increased significantly over the past 15 years, the investigators hope to find biochemical~     markers (i.e. pro-inflammatory mediators) in the esophagus. The investigators hope these~     samples will lead us to a differential expression of molecular markers and inflammatory~     mediators in the varying degrees of esophageal disorder~   "
83311|NCT02476500|"~     In a prospective case-control study, 140 medical students (,novices') and 10 Senior~     gynecologists (,experts') will perform a Large Loop Excision of the Transformation Zone~     (LLETZ) on a Training model afte having undergone a Video Training session. Their~     LLETZ-Performance will be assessed using an Objective Structured Assessment of Technical~     Skills (OSATS) protocol designed for judging the surgical proficiency when performing a~     LLETZ. Using metrical and non-metrical data points, construct validity of the LLETZ training~     model to distinguish between experts and novices will be assessed. Secondary endpoints are~     differences in OSATS scores within the group of novices based on gender and handyness, as~     well as satisfaction of the novices with the learning experience.~   "
83312|NCT02476487|"~     Background: Staphylococcus aureus bacteremia (SAB) is frequently encountered in hospitals,~     with high rates of morbidity and mortality. Duration of antimicrobial treatment for SAB,~     other than in cases of Infective endocarditis (IE), recommended by different guidelines~     relies on risk stratification for relapse of infection rather than definite diagnosis of~     septic foci that eventually determine the relapse rate. In recently published studies~     fluorodeoxyglucose (FDG) PET CT was found to be a sensitive imaging test for identifying~     metastatic infectious foci in Gram-positive bacteremia, including SAB.~      Objectives: To examine the impact of using FDG PET CT in the diagnostic algorithm of non-IE~     SAB compared to standard treatment recommendations on treatment duration and clinical~     outcomes.~      Methods: A prospective interventional non-comparative cohort study conducted at Rambam Health~     Care Campus. Patients with SAB, defined as microbiologically and clinically, will undergo FDG~     PET CT 10-14 days following the first positive blood culture for diagnosis of septic~     extra-cardiac foci of infection. Patients with IE will be excluded. Short (2 weeks) versus~     long treatment (4-6 weeks) will be recommended for negative and positive PET CT tests,~     respectively. Patients will be followed-up for 1 year for relapse of infection and mortality.~      We will document the sensitivity and specificity of PET CT for detection of complications~     among patients with SAB. We will examine the percentage of patients in whom the use of PET CT~     changed treatment duration compared to standard recommendations. We will compare also, the~     relapse rate and 1 year mortality rate with data from previous studies and local data.~     Assuming a 15% rate of management changes compared to consensus recommendations, a sample of~     150 patients will achieve the required 95% CI.~      Significance: Our trial will serve for improving decision making in patients with non-IE SAB,~     shortening treatment duration in unnecessary cases and decreasing relapse rate by giving~     prolonged appropriate treatment for metastatic infection not identified by standard~     management algorithms. PET CT is assuming an increasingly important role in infection~     diagnosis and management. The current study will be the first to examine the role of PET CT~     in directing management of patients with SAB.~   "
83313|NCT02476474|"~     Laparoscopic Sleeve Gastrectomy (LSG) creates a vertical gastrectomy which results in a~     narrow and tubular shape of stomach. The line of resection starts at 3-6 cm. from pylorus~     (antrum) toward to the angle of His. The gastric antrum plays a major role in gastric~     emptying, particularly for solids. Hence, depending upon the starting point of gastric sleeve~     resection in each center, this can result in difference of the remaining gastric antrum which~     may affect gastric emptying time after this procedure.~   "
83314|NCT02476461|"~     The purpose of this study is to investigate whether percutaneous needle fasciotomy is as~     effective for treating Dupuytrens contracture as Xiapex. Immidiate treatment effect is to be~     investigated, as iskontracture size after 5 years. Contracture size after one and three~     years, and subjective hand function is also to be investigated.~   "
83315|NCT02476448|"~     This study evaluates 4 different methods to aid surgeons visualize ureteral jets on~     cystoscopy.~   "
83316|NCT02476435|"~     The purpose of this study is to assess the therapeutic efficacy of transcranial magnetic~     stimulation in patients with depersonalization disorder.~   "
83317|NCT02476422|"~     The study is designed to assess the efficacy and tolerability of diclofenac potassium soft~     gelatin capsules compared with ibuprofen tablets in patients with moderate to severe~     postoperative dental pain.~   "
83318|NCT02476409|"~     Patients who present to clinic or in the outpatient setting with worsening heart failure~     represent a unique opportunity for novel approaches to decongestion (removing fluid) that may~     more rapidly improve fluid status and symptoms as well as reduce the risk of hospitalization.~      In these patients with less severe congestion (fluid overload), combining the vasopressin~     antagonist tolvaptan with loop diuretics (or fluid pills like~     furosemide/bumetanide/torsemide) may represent a more effective strategy for decongestion. In~     addition, looking at patients' copeptin levels may help identify those who are more likely to~     respond to tolvaptan.~   "
83319|NCT02476396|"~     The purpose of the research is to understand structural plaque abnormalities that make a~     carotid plaque unstable and brake off (embolize) which would help to predict and treat~     individuals who are likely to suffer not only classic episodic major strokes but also~     cognitive impairment.~   "
83320|NCT02476383|"~     This study considers whether treatment effects in response to spinal manipulative therapy for~     individuals experiencing low back pain are dependent upon the context in which the~     intervention is provided. Half of the participants will receive spinal manipulative therapy~     with encouragement to interact with the provider and information to enhance expectations for~     the effectiveness of the intervention. The other half will receive spinal manipulative~     therapy with minimal interaction with the provider.~   "
83321|NCT02476370|"~     This study aims to test the effects of a Preoperative Relaxation intervention and an~     Intensified Surgery Patient Education on pre- and postoperative wellbeing and health in~     Patients Undergoing Herniotomy.~   "
83322|NCT02476357|"~     Patients undergoing groin or axillary Radical lymph node dissection (RLND) or completion~     lymph node dissection (CLND, after positive sentinel lymph node biopsy (SLNB) for melanoma or~     breast cancer were randomized in a controlled trial for surgical dissection technique.~     Harmonic scalpel dissection were compared with classic dissection in term of lymphocoele and~     oedema.~   "
83323|NCT02476344|"~     2 young candidates have tragically died during army pre-recruitment sorting series in 2006.~     As part of the classification and characterization of the physical aspects of the training,~     this experiment was requested.~      We aim at determining the characteristics of physical strains in sorting series, by objective~     and subjective parameters and evaluating the difficulty levels and intensity of those~     strains.~   "
83324|NCT02476331|"~     Bipolar disorder (BD) is characterized by extreme changes in mood and emotion dysregulation.~     Mood changes are episodic in nature, with distinct periods of mania, depression, and~     asymptomatic periods of euthymia. In addition to impairments in mood, cognitive impairments~     are a common feature of the disorder. These cognitive impairments persist during periods of~     euthymia and are associated with negative clinical and psychosocial outcomes. Specifically,~     individuals with BD show impairments in executive functions. Recent studies show that emotion~     regulation can be down-regulated by taxing executive functions, and it can be improved with~     working memory training, a specific component of executive functions. These initial studies~     show that emotion regulation is under executive control in healthy individuals; however, the~     nature of this relationship is not well understood in populations that are affected by~     impairments in both executive control and emotion regulation. Previous work on cognitive~     training has not targeted specific cognitive domains with an emphasis on understanding the~     underlying mechanisms that promote change. Moreover, well-controlled randomized control trial~     (RCT) studies are needed in order to provide high quality evidence to inform the efficacy of~     cognitive training interventions for psychiatric populations. The aim of the proposed study~     is to use a commercially available cognitive training program to study the effects of working~     memory training on cognitive, clinical, and psychosocial outcomes in patients with BD. We~     hypothesize that training working memory will lead to improvements in cognitive and emotional~     functioning, leading to downstream changes that will positively impact untrained outcomes,~     such as mood and community functioning.~   "
83325|NCT02476318|"~     A prospective, multi-center study to evaluate the safety and performance outcomes of the~     ArterX Vascular Sealant when used for prophylactic sealing of suture lines at the anastomosis~     between native vessel and synthetic vascular grafts.~   "
83326|NCT02476305|"~     Desmoid tumors (DT) are rare tumors (2-4 cases/million/year) that originate from~     musculoaponeurotic structures. Although they are benign tumors with no metastatic potential,~     DT are considered as locally aggressive tumors, with local invasiveness and tissue~     destruction, leading to pain, and disability. Surgery remains the keystone of therapy, but is~     limited by the anatomical situation of extra-abdominal desmoid (EAD) tumors (chest wall, root~     members). In patients where surgery is considered, negative-margin resection (R0) is~     recommended, but this frequently results in cosmetic/functional impairment. Moreover,~     prognostic impact of R0 resections remains controversial. The outcome after initial surgery~     depends upon several factors such as age, tumor site, and tumor size as demonstrated by~     recent data from the French Sarcoma Group.~      Alternative therapies to DT surgery for front-line or recurrence include NSAID's,~     anti-estrogens alone or in combination, -interferon, chemotherapy, targeted therapies or~     radiation therapy. All of these medical approaches however may fail to achieve long-term~     disease control and a number of patients suffer from irreducible pain, and disability from~     tumor volume.~      Cryoablation is a promising technique that is suitable for patients experiencing~     extra-abdominal DT. The procedure is based on repeated cycles of freezing/passive thawing of~     the tumor, leading to cell death. The technique has many advantages, among which: the~     accurate control of iceball under real-time MRI or CT-scan monitoring (that is not possible~     with other techniques such as radiofrequency), the lack of mutilation, the possibility of~     repeating the procedure. The cryoablation procedure has proven to be beneficial for the~     treatment of various tumors (liver metastases, breast, kidney). Recently, percutaneous~     cryotherapy has been reported in the treatment of EAD tumors poorly suited to surgery, with~     promising results.~      In the light of these encouraging data, it is believed that patients with extra-abdominal DT~     not amenable to surgery unless unacceptable surgical sequel and progressing after at least~     two lines of adequate medical therapy (tamoxifen, NSAID or chemotherapy), could benefit from~     the cryoablation procedure. Tumor cryotherapy-induced regression should allow symptoms~     relief, prolonged progression-free survival and a better quality of life.~   "
83327|NCT02476292|"~     The purpose of this study is to learn about the impact of vasculitis on employment and income~     in patients with different systemic vasculitides. All patients enrolled in the Vasculitis~     Clinical Research Consortium (VCRC) Patient Contact Registry, living in USA or Canada, and~     followed for more than 1 year since the vasculitis diagnosis will be invited via email to~     participate in this study, based on an online survey.~   "
83328|NCT02476279|"~     Background: Pancreatitis is the most frequent complication of endoscopic retrograde~     cholangiopancreatography (ERCP), accounting for substantial morbidity, occasional mortality,~     and increased health care expenditures. Until recently, the only effective method of~     preventing post-ERCP pancreatitis (PEP) had been prophylactic pancreatic stent placement~     (PSP), an intervention that is costly, time consuming, technically challenging, and~     potentially dangerous. The investigators recently reported the results of a large randomized~     controlled trial demonstrating that rectal indomethacin, a non-steroidal anti-inflammatory~     drug, reduced the risk of pancreatitis after ERCP in high-risk patients, most of whom (>80%)~     had received a pancreatic stent. Secondary analysis of this RCT suggested that subjects who~     received indomethacin alone were less likely to develop PEP than those who received a~     pancreatic stent alone or the combination of indomethacin and stent, even after adjusting for~     underlying differences in subject risk. If indomethacin were to obviate the need for PSP,~     major clinical and cost benefits in ERCP practice could be realized.~      Objective: To assess whether rectal indomethacin alone is non-inferior to the combination of~     rectal indomethacin and prophylactic pancreatic stent placement for preventing post-ERCP~     pancreatitis in high-risk cases.~      Methods: Comparative effectiveness multi-center non-inferiority trial of rectal indomethacin~     alone vs. the combination of rectal indomethacin and prophylactic pancreatic stent placement~     for the prevention of post-ERCP pancreatitis in high-risk patients. One thousand four hundred~     and thirty subjects at elevated risk for PEP who would normally receive a pancreatic stent~     for prophylaxis will be randomized to indomethacin alone or the combination of indomethacin~     and PSP. The proportion of patients developing PEP and moderate-severe PEP will be compared.~     In addition, the investigators will establish a quality-assured central repository of~     biological specimens obtained from study participants, permitting future translational~     research elucidating the molecular and genetic mechanisms of PEP, as well as the mechanisms~     by which non-steroidal anti-inflammatory drugs prevent this complication.~   "
83329|NCT02476266|"~     Parkinson's disease (PD) is a chronic neurodegenerative disorder that is characterized by a~     multitude of symptoms. Impairments in balance, muscle deficits and increased risk of falls~     are commonly experienced in PD.The purpose of this study is to investigate the effects of two~     different resistance training programs on improving balance and muscular strength to thereby~     reduce the risk of falls in those with PD. This study will randomize individuals to one of~     two groups, a power training group, or a strength training group. Both interventional groups~     will participate in 12 weeks of resistance training, two times per week for an hour each~     exercise session.~   "
83330|NCT02476253|"~     The purpose of the present study is to compare the adjunct treatment of metabolic or mixed~     severe acidosis in the critically ill using Sodium Bicarbonate as a buffer to increase the~     plasma pH vs no buffering therapy.~      The study is a randomized multiple center clinical trial with the outcome as a primary~     endpoint.~   "
83331|NCT02476240|"~     The purpose of this study is to evaluate the underlying mechanism and influence of externally~     vs. internally focused exercise on rehabilitation in Parkinson's disease. The upcoming~     exercise intervention methodology will aim to meet the requirements of a 1A silver ranking~     level, single blind, randomized control trial according to the criterion of the Cochrane~     Musculoskeletal Review Group~   "
83341|NCT02476110|"~     Hypothesis : At hospital discharge for home, the medical prescription of ONS according to the~     official criteria of SSNC and the legal regulations (completed prescription according to~     health's insurance and homecare delivery) dictates the compliance of the patient and the~     reimbursement of the ONS.~   "
83332|NCT02476227|"~     Catheter ablation in the treatment of atrial fibrillation (i.e. pulmonary vein isolation) is~     now the most effective method of prevention of arrhythmia recurrence. Use of 3D~     electroanatomical system is now a golden standard.~      Background hypothesis is that automatic algorithm collecting ablation points during pulmonary~     vein isolation (with certain catheter stability time, range of motion, and catheter-tissue~     contact force) prevents forming the gaps in the ablation line, thus preventing pulmonary vein~     reconnection and AF recurrence. The aim of the trial will be 1:1 comparison of the two~     methods of pulmonary vein isolation: with manual vs. automatic collection of ablation points~     using CARTO system and contact force catheter.~   "
83333|NCT02476214|"~     Prenatal care is defined as pregnancy-related health care services provided to a women~     between conception and delivery. Early, comprehensive prenatal care can promote healthier~     pregnancies and can reduce the risk of some adverse birth outcomes by detecting and managing~     preexisting medical conditions, by providing health behavior advice, and by offering a~     gateway into the health care system for socially disadvantaged women . The customary approach~     for prenatal care includes routine individual care, which is provided by nurses and~     physicians in healthcare clinics and hospitals. Since 1995, citizens of Israel, have been~     entitled to health care services according to the National Health Insurance Law . Israeli~     citizens are covered by National Health Insurance, and get maternal and child preventive~     services including prenatal care by local Mother and Child Health Clinics . The prenatal care~     is individual. A nurse meets with every registered pregnant women, assess the medical and~     emotional condition and provide guidance related to the pregnancy week of the woman.~      Since the 70, a number of group prenatal care intervention programs are described in the~     literature. Group prenatal care is designed to answer the recommended content for prenatal~     care for improving the quality of care and resulting in improved pregnancy outcome . The~     group prenatal care includes three important components: risk assessment. Guidance and~     support and combines them into the prenatal care22. Creation of the group provides a meeting~     place for pregnant women. A safe place for sharing and learning from each other and to build~     a community for mutual support .~      The investigators hypothesize that, relative to women who receive standard individual~     prenatal care, the women who receive group prenatal care will be more likely to:~        1. Report higher levels of satisfaction. The investigators also anticipate higher levels of~          staff satisfaction within the intervention group medical staff.~        2. Higher levels of knowledge about pregnancy related issues (e.g., health behaviors during~          pregnancy, tests during pregnancy).~        3. Higher levels of compliance for recommended prenatal care screening tests (e.g., GCT,~          first and second trimester screening, US)~        4. have better perinatal outcomes: better health behaviors during pregnancy (e.g.,~          nutrition, physical activity ext.'), better birth outcomes (e.g., preterm labor, low~          birthweight,), and better postpartum indicators (e.g., increased breastfeeding);~   "
83334|NCT02476201|"~     The purpose of the study is to assess prospectively at 6 months the percentage of responder~     patients implanted with a Cardiac Resynchronization Therapy (CRT-D) device and a Quartet Left~     Ventricular (LV) quadripolar lead and with the MultiPoint Pacing (MPP) feature activated.~   "
83335|NCT02476188|"~     The purpose of the study was to investigate the correlation between the nucleosome~     concentration and the rate of recanalization after thrombolysis. All patients were admitted~     to the Stroke Unit at the University Hospital Sainte-Anne where they received standard stroke~     care. The investigators included all patients treated or not by intravenous thrombolysis for~     anterior circulation stroke with or without vessel occlusion. Exclusion criteria were~     neoplasms, chronic inflammatory diseases and cytostatic therapy at the time of stroke and~     stroke-specifics symptoms that had started earlier than 4.5 hours before admission.~   "
83336|NCT02476175|"~     The objective is to evaluate the efficacy and safety of adding mirabegron to an~     antimuscarinic to treat urinary incontinence in children with Overactive Bladder that are~     refractory to antimuscarinics.~   "
83337|NCT02476162|"~     Second malignant neoplasms and cardiac late effects are primary drivers of serious~     non-recurrence morbidity and mortality in long term childhood cancer survivors. Cardiac late~     effects have been most prominently associated with exposure to high doses of anthracyclines~     or chest radiation. While increased recognition of late effects has resulted in risk-targeted~     therapy and reductions in use of high dose radiation and anthracyclines for many patients,~     these cardiotoxic exposures continue to be essential components of curative childhood cancer~     therapy. In addition, as survivors age they are increasingly susceptible to other general~     risk factors for cardiovascular disease recognized in the general population, such as~     hypertension, obesity, dyslipidemia, and diabetes.~      This study will evaluate a high blood pressure monitor (HBPM)-based intervention for the~     early detection of pre-hypertension and prevention of clinical hypertension in survivors of~     childhood cancer. Eligible and consenting participants will be randomized into one of three~     groups:~      GROUP 1: Instructed to measure blood pressure (BP) every day for 3 months. GROUP 2:~     Instructed to measure BP for 7 consecutive days once a month, for 3 months.~      GROUP 3: Instructed to measure blood pressure for 3 consecutive days each month, for 3~     months.~      The randomization to the above groups will be done using sequential assignment of newly~     recruited participants based on a randomly ordered list.~      PRIMARY OBJECTIVE:~        -  Evaluate the feasibility of High Blood Pressure Monitoring (HBPM) for three consecutive~          months using a remote blood pressure device provided to participants of the St. Jude~          Lifetime cohort (SJLIFE) protocol.~      SECONDARY OBJECTIVES:~        -  Assess compliance with use of HBPM by measurement frequency, evaluating overall and~          defined minimum use in each of the three different groups.~        -  Assess compliance with use of HBPM by cell phone status, evaluating those with and~          without a personal cell phone capable of connecting directly to the home blood pressure~          monitoring device via Wi-Fi or Bluetooth network.~   "
83338|NCT02476149|"~     In keratoconus (KC) corneal thinning and protrusion can cause myopia and irregular~     astigmatism, affecting vision. The biomechanical properties of the cornea is maintained by an~     intricate collagen network, which is responsible for its shape and function. In KC this~     collagen network is disrupted resulting in the cornea losing its shape and function.~     Keratoconic changes are focal and localised to certain regions of the cornea and the early~     detection of these changes is challenging. Screening methods include corneal topography~     (evaluation of anterior corneal surface curvature), tomography (assessing the morphological~     features of the anterior segment) and aberrometry (measuring the optical aberrations of the~     eye). More recent research suggests that the biomechanical destabilization of the cornea may~     precede topographic and tomographic evidence of KC. Management of KC depends on disease~     severity with severe cases being treated with keratoplasty and less severe cases with~     cornealcollagencrosslinking (CXL). CXL is an emerging technique, which aims to increase the~     biomechanical strength of the keratoconic cornea. Despite strong evidence of changes in the~     biomechanical properties in human corneas following CXL, there is a significant need for~     accurate measures of biomechanical changes in vivo pre and post CXL. Until recently technical~     limitations have restricted the ability to assess the biomechanical properties of the whole~     cornea in vivo. With the introduction of the CorvisST (Oculus) it is now possible to assess~     regional biomechanical behaviour of the cornea. The output from the device provides a variety~     of parameters to indicate the cornea's biomechanical strength. To date, the association~     between the deflection behaviours in various regions of the cornea in keratoconic eyes preand~     post CXL has not been studied. In order to effectively assess the clinical benefits of CXL~     such information is vital. The primary goal of this investigation is to investigate regional~     biomechanical properties of the keratoconic eye before and after CXL.~   "
83339|NCT02476136|"~     Anxiety disorders are common disorders, which pose a major burden to society and the~     individual. An anxiety disorder may be treated with medication, in particular with~     antidepressants such as the selective serotonin reuptake inhibitors (SSRIs). However, much of~     what is known about antidepressants is derived from research in depression rather than~     anxiety. In recent years, researchers have found that antidepressants are more effective for~     severely depressed patients than they are for patients with milder symptoms. It is possible~     that a similar relationship between symptom severity and antidepressant efficacy exists for~     anxiety disorders, but there is currently little evidence available to answer this question.~     As antidepressants are frequently prescribed to patients with mild or moderate anxiety, a~     clear understanding of their effectiveness across the severity range is vital to inform~     treatment decisions. Therefore, the purpose of this meta-analysis is to examine whether~     initial symptom severity affects antidepressant efficacy for anxiety disorders.~   "
83375|NCT02475668|"~     Study to evaluate the %SpO2 accuracy performance of the Nonin Medical pulse oximetry systems.~   "
83342|NCT02476097|"~     Rebound acid hypersecretion (RAHS), defined as an increase in gastric acid secretion above~     pre-treatment levels after PPIs therapy is observed within two weeks after withdrawal of~     treatment and could theoretically lead to acid-related symptoms such as heartburn, acid~     regurgitation, or dyspepsia that might result in resumption of therapy. A plausible~     physiologic theory for the rebound phenomenon suggests that long-term, elevated gastric pH~     caused by blockage of the proton-pumps stimulates compensatory gastrin release.~     Interestingly, Reimer et al. demonstrated the occurrence of RAHS in healthy volunteers who~     had received eight weeks of esomperazole. The clinical symptoms occured in a different~     prevalence compared with placebo treated patients at ten weeks after withdrawal and until the~     end of the study (twelve weeks). Twenty to twenty-two percent of patients displayed symptoms~     ten or twelve weeks after having discontinued PPIs while they occured in 1.7-7% of~     placebo-treated patients. Efforts should be pursued to restrict PPI therapy use to patients~     likely to benefit from it.~      In this context, we propose to investigate the benefit of a progressive decrease in doses of~     esomeprazole compared to a sudden discontinuation. This is a randomized, double-blind,~     placebo-controlled trial with 156 patients treated by esomeprazole 40mg since four weeks~     least, randomized to one week of placebo or one week of esomeprazole 20mg. We want to compare~     the prevalence of clinical gastrointestinal symptoms between patients with progressive~     discontinuation (one week of esomeprazole, 20mg, then discontinuation) or those with sudden~     discontinuation of esomeprazole 40mg.~   "
83343|NCT02476084|"~     The purpose of this study is to determine the kinetics of change in quantitative measures of~     joint inflammation by state of the art power Doppler vascular imaging and to identify~     biomarkers in biological samples (synovial biopsies, DNA, RNA, PBMC, serum, plasma, urine and~     stool samples) from parallel cohorts of RA patients undergoing different treatments. This~     will be achieved implementing MSUS assessments, standard laboratories techniques (such as~     ELISAs, gene profiling, transcriptome analysis etc.) and the novel CyTOF™ technology.~   "
83344|NCT02476071|"~     The study, funded by the Bill and Melinda Gates Foundation, will test a novel demand~     generation strategy, Stylish Man, to increase uptake of safe voluntary male circumcision~     (VMC) for HIV in Rakai, Uganda. With President's Emergency Fund for AIDS Relief (PEPFAR)~     funds, the Rakai Health Sciences Program (RHSP) provides VMC in Rakai District, Uganda. The~     investigators' ongoing 54 village Rakai Community Cohort Study (RCCS), with community HIV~     prevalence ranging from 6% to 42%, provides longitudinal data on rates of VMC coverage and on~     HIV incidence. The investigators have preliminary evidence that VMC is reducing HIV incidence~     in Rakai, but coverage remains suboptimal (as elsewhere in Africa), reducing program impact.~     The investigators' data suggest that VMC supply is not the limiting factor, but that there~     is a deficit in demand.~      Based on extensive qualitative research, the investigators have developed and piloted an~     innovative male-focused VMC demand generation strategy, the Stylish Man Program (SMP). The~     VMP strives to demedicalize VMC by de-emphasizing health-focused messages and instead~     stressing taking charge of your life. The SMP has two distinct but related elements: (1)~     mass media (MM) via radio and posters; and (2) community-level mobilization via the Stylish~     Man Event (SMEvent) which includes multimedia media (the Stylish Van, videos, music, health~     promoters) into which the investigators have embedded VMC promotion, and immediate access to~     services. In this study, the investigators will conduct a one year cluster randomized trial~     of MM plus SMEvents (intervention arm) compared to MM alone (control), in 20 RCCS~     communities, half randomzied to the intervention and half to the control arm.~      The primary outcome will be intent-to-treat community-level rates of VMC coverage by arm,~     ie., the percentage of non-muslim men in each arm who accept and adopt MMC. (Over 95% of~     Muslim men in Rakai already receive male circumcision in infancy.) As secondary outcomes, we~     will also monitor rates of key behaviors and HIV incidence, and compare them between arms and~     to rates observed in communities in each arm prior to study initiation.~   "
83345|NCT02476058|"~     The purpose of this study is to evaluate the safety and tolerability of JNJ-42847922 in~     participants with Major Depressive Disorder (MDD).~   "
83346|NCT02476045|"~     Open label, randomized, multicenter, phase II study to compare the efficacy, in terms of~     non-inferiority of progression-free survival (PFS), of maintenance with panitumumab alone~     (arm B) as compared to panitumumab with 5-fluorouracil (5-FU) and leucovorin (LV) (arm A)~     following induction treatment with 5-fluorouracil + leucovorin+oxaliplatin (FOLFOX-4) and~     panitumumab in patients with RAS wild-type, metastatic colorectal cancer.~      The study involves an induction phase with panitumumab as 1 hour intravenous infusion at the~     dosage of 6 mg/kg, given every two weeks, plus FOLFOX-4 chemotherapy as standard guidelines.~      Before start of FOLFOX-4 plus panitumumab, at the time of enrollment, patients will be~     immediately randomized electronically 1:1 to one of the two maintenance arms. Induction~     treatment with FOLFOX-4 plus panitumumab will continue until progressive disease,~     unacceptable toxicity or informed consent withdrawal, or for up to 8 cycles. At the end of~     induction treatment, in presence of complete or partial response, or stable disease,~     non-progressing patients will be allocated to one of the two pre-assigned maintenance arms:~      A) 5-FU/LV (De Gramont regimen) plus panitumumab given at 6 mg/Kg every two weeks until~     progressive disease, unacceptable toxicity or informed consent withdrawal B) Panitumumab~     alone given at 6 mg/Kg every two weeks until progressive disease, unacceptable toxicity or~     informed consent withdrawal Imaging studies (thorax and abdominal CT or MRI scan) will be~     performed at baseline (4 weeks prior enrollment) and every 8 weeks (4 cycles) during~     treatment.~   "
83347|NCT02476032|"~     The purpose of the study is to evaluate the efficacy of Sensi-StopTM strips (Procter &~     Gamble™) on the relief of dentinal hypersensitivity. In other words, do Sensi-StopTM strips~     (Procter & Gamble™) reduce or eliminate cold sensitivity in teeth? In addition, the~     investigators will evaluate whether there is a difference in the Sensi-StopTM strip (Procter~     & Gamble™) effectiveness when the product is placed by a dental professional compared to~     self-placement by the person with sensitive teeth. This product is not experimental.~   "
83348|NCT02476019|"~     The purpose of this study is to to evaluate the safety, tolerability, pharmacokinetics, and~     pharmacodynamics of ISIS-FGFR4RX.~   "
83349|NCT02476006|"~     Primary Objective:~      To provide patients with severe hypercholesterolemia at risk for subsequent cardiovascular~     (CV) events and not adequately controlled with currently available lipid-modifying therapy~     (LMT) access to alirocumab ahead of commercial availability and to document the overall~     safety and tolerability of alirocumab in this patient population.~      Secondary Objectives:~      To document the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels as~     well as non-high-density lipoprotein cholesterol (non-HDL-C), total cholesterol (total-C),~     high-density lipoprotein cholesterol (HDL-C), and triglyceride (TG) levels after 12 weeks of~     treatment.~      To document patient's acceptability of self-injection (Self Injection Assessment~     Questionnaire, SIAQ).~   "
83376|NCT02475655|"~     The purpose of this study is to evaluate the safety and tolerability of ruxolitinib in~     HIV-infected adults who are virologically suppressed and who are on antiretroviral therapy~     (ART).~   "
83350|NCT02475993|"~     The purpose of this study is to test a web-aided, mobile-based PHR (Personal Health~     Reporting) service to enhance SCD outpatient treatment after discharge from an acute care~     setting, such as Duke University Medical Center's Day Hospital. SMART is a new mobile~     application created by SickleSoft to increase patient involvement in their treatment and~     improve patient to doctor communication. SMART is a self-monitoring and management service~     for SCD patients and their treatment doctors. This study will test whether or not use of the~     SMART mobile application will help develop the type of patient-doctor relationships that lead~     to better health outcomes and a decrease in readmission to an acute care facility.~   "
83351|NCT02475980|"~     The purpose of this pilot study is to determine the feasibility of comprehensive~     contraceptive counseling intervention in a pediatric emergency department and to determine~     the impact of comprehensive contraception counseling on initiation of contraception among~     sexually active adolescents presenting to a pediatric emergency department.~   "
83352|NCT02475967|"~     In the trial cardiac patients will be provided with unrestricted access to the web-based~     eLearing platform for a one-month period.~   "
83353|NCT02475954|"~     When Veterans with Parkinson's disease (PD) suffer from depression, they are more likely to~     experience disease complications, interpersonal difficulties with caregivers, and poorer~     quality of life. Unfortunately, depression in Veterans with PD is inadequately treated at the~     current time. Treatment for depressed Veterans with PD will require the elimination of~     geographical barriers to care and approaches that address the unique aspects of PD. The~     proposed study will be the first to explore a novel and innovative, PD-informed psychotherapy~     package for depressed Veterans with PD and their Caregivers, delivered through video-to-home~     telehealth. If the results of this proposal are promising, a much needed treatment can be~     made available to Veterans with PD and their Caregivers across the country, regardless of~     geographical location.~   "
83354|NCT02475941|"~     The investigators will be looking at geriatric distal femur fractures. The investigators will~     prospectively enroll these patients and allow patients to either weight bear as tolerated or~     limit their weight bearing post operatively. The investigators will evaluate functional~     outcomes.~   "
83355|NCT02475928|"~     The purpose of this study is to evaluate the effect of zinc supplementation in the treatment~     for dysgeusia, progression disease and quality of life in patients with liver cirrhosis.~   "
83356|NCT02475915|"~     This study is a two-arm prospective 1:1 randomised controlled trial comparing the proportion~     of patients between:~      Group 1: vorinostat/hydroxychloroquine/maraviroc (VHM) co-administered with anti-retroviral~     therapy (ART) Group 2: ART only who are able to maintain HIV RNA < 50 copies/ml following~     treatment interruption. Subjects will be recruited from RV254/SEARCH 010, an acute HIV~     infection cohort conducted by the Thai Red Cross AIDS Research Centre in Bangkok, Thailand.~     The study will run for a minimum of 34 weeks from screening.~   "
83357|NCT02475902|"~     The participants will complete a series of balance assessments with a licensed physical (PT)~     or occupational therapist (OT) or qualified research assistant (RA) at Blue Marble Game Co or~     in their respective homes at the start of the study, at crossover and upon completion of the~     study. During this study a PT, OT, or RA trained in fall risk management will supervise the~     instruction and practice by participants of the home exercise programs during the initial 2-3~     hour introduction to the study activities. Participants will be asked to exercise 3/week for~     one month then crossover to the alternative exercise program and exercise 3/week for a second~     month.~   "
83358|NCT02475889|"~     It has been shown that RFA induced systemic tumor antigen-specific T cell responses in human~     carcinoma. However, there are insufficient studies on the immune modulation of tumor~     microenviroment (TME) outside of the ablation zone. In order to study how RFA modifies TME in~     human cancer patients, investigators performed a retrospective study of a unique cohort of~     patients who suffered from synchronous CRCLM.~   "
83359|NCT02475876|"~     Developmental changes in physiology during childhood influence drug dosing. Failure to~     account for these changes leads to improper dosing, which is associated with decreased drug~     efficacy and safety in children. Population physiologically-based pharmacokinetic (PBPK)~     modeling offers the opportunity to predict optimal drug dosing based on physiologic~     parameters adjusted for developmental changes.~      PBPK models are mathematical constructs that incorporate physiologic processes with drug~     characteristics and genetic variances to characterize the dose-exposure relationship across~     the age continuum. These models integrate drug-specific (e.g., metabolism, protein binding)~     and systems-specific (e.g., organ size, blood flow) information to predict the effect of~     different factors (e.g., age, genetic variants, disease) on drug exposure. By accounting for~     these factors and using data from clinical trials to confirm the modeling, PBPK models can~     reduce the number of children needed for clinical trials while maximizing dose-based efficacy~     and safety.~      This trial will evaluate a platform to prospectively validate population PBPK models in~     children. The study drugs, clindamycin and Bactrim (aka TMP-SMX), are ideal candidates to~     evaluate population PBPK models in children due to their differing physico-chemical~     properties and elimination pathways. In addition, a trial of clindamycin and TMP-SMX has~     broad clinical applicability, as both drugs are among the most commonly used agents to treat~     gram-positive infections in infants and children.~   "
83360|NCT02475863|"~     This study compares the clinical effectiveness of a new algorithm (model-based warfarin~     dosing) with standard practice (doctor's own judgement and intuition) designed to determine~     the most appropriate anticoagulant dose of warfarin in children after congenital heart~     surgery.~   "
83361|NCT02475850|"~     The aim of this pragmatic cluster-randomized trial is to determine the effectiveness of an~     evidence-based, patient-centered multifactorial fall injury prevention strategy in community~     dwelling older adults at risk of falls recruited from 86 primary care practices around the~     U.S.~   "
83377|NCT02475642|"~     The purpose of this study is to compare the efficacy and safety of PV isolation with~     continued antiarrhythmic drug treatment (PVI+ADT) to PV isolation without continued ADT~     (PVI-ADT) in patients undergoing treatment for symptomatic recurrent AF.~   "
83378|NCT02475629|"~     This Phase 3, single arm, multicenter study will evaluate the safety and effectiveness of~     ibalizumab in treatment-experienced patients infected with multi-drug resistant HIV-1.~   "
83362|NCT02475837|"~     The Objectives of this study are:~        1. To determine if vorapaxar safely improves arteriovenous (AV) fistula functional~          maturation when administered during the maturation process compared with placebo.~        2. To determine if vorapaxar safely improves AV fistula patency, allowing for secondary~          procedures to aid in fistula maturation compared with placebo.~        3. To determine if vorapaxar safely facilitates successful cannulation of AV fistulas for~          hemodialysis compared with placebo.~      This is a randomized placebo-controlled double-blind pilot trial. Study procedures will be~     conducted at Stanford University Medical Center, and standard-of-care (SOC) procedures will~     be conducted at Stanford and it's affiliated hospitals (Veteran's Affairs Palo Alto Health~     Care System and the Stanford Vascular Surgery Clinic at Valley Medical Center). The~     investigators expect to enroll 128 patients. Patients will be assigned to treatment groups~     with a 1:1 randomization in blocks of 4 at the conclusion of the AV fistula creation.~     Patients will be stratified based on fistula location (lower arm versus upper arm).~   "
83363|NCT02475824|"~     This is a single-center, prospective, randomized, double-blinded study of consecutive~     patients referred for ERCP. A recent study suggested that the addition of dexmedetomidine to~     the midazolam-meperidine regimen (MMD)provided better sedative efficacy and a superior safety~     profile during ERCP compared with a midazolam-meperidine regimen. Further study is warranted~     to compare an MMD regimen with propofol-based regimen.~      Randomization is performed by use of a computer-generated random allocations in a ratio of~     1:1 in balanced blocks of 4. A separate sedating nurse, who don't participate in the study,~     is the only person with knowledge of the sedation regimen. This separate nurse repeated the~     injection of propofol and completed questionnaires.~   "
83364|NCT02475811|"~     One hundred healthy women with singleton pregnancies in the 1st stage of labor will be~     included in the study, divided into two groups; Group A (n: 50 - women pregnant ± 34-37~     weeks) & Group B (n: 50 - women pregnant ± 37+1-40 weeks). A 3D volume model of the right~     fetal lung is generated & lung volume is calculated using VOCAL software. After child birth,~     neonatal respiratory functions will be assessed using APGAR score at (1, 5 and 10 min)~     together with occurrence of RDS and the further need for NICU admission and respiratory~     support measurements.~   "
83365|NCT02475798|"~     The purpose of this extended study is to collect confirmatory safety and effectiveness data~     on the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the~     commercially available Atrium iCAST™ covered stent in the treatment of aortoiliac and iliac~     aneurysms.~   "
83366|NCT02475785|"~     The purpose of this study is to determine if the Forsus Fatigue resistant Device appliance~     with direct skeletal mini plates anchorage is capable of achievement of skeletal mandibular~     effects while preventing the excessive proclination of the lower incisors at the end of the~     treatment when compared to the conventional Forsus Fatigue resistant Device appliance applied~     to the upper and lower dental arches in female patients with skeletal Class II malocclusion~   "
83367|NCT02475772|"~     Fifteen women with recurrent ovarian cancer will be treated by an intraperitoneal~     chemotherapy with cisplatin and doxorubicin in three escalating dosage schedules. The aim of~     the study is to evaluate the safety and tolerability of doxorubicin and cisplatin every 4~     weeks for three courses using a three-group, dose-escalation protocol with fixed~     dose-density. The time Frame for the assessment of the Primary outcome is therefore 12 weeks.~     Predefined toxicity criteria will be applied using CTCAE version 4.0 criteria. The study~     hypothesis is that local and systemic toxicity will increase with increasing dosage of~     cisplatin and doxorubicin during three repeated PIPAC courses with no CTCAE grade 4 and 5~     events in any treatment group.~   "
83368|NCT02475759|"~     Nutritional Prehabilitation Program and Cardiac Surgery Outcome in Pediatrics. A randomized~     controlled trial.~   "
83369|NCT02475746|"~     The purpose of this study is to evaluate the effect of itraconazole after multiple dose~     administration on the single dose PK of PF-06372865.~   "
83370|NCT02475733|"~     This study will assess the safety , efficacy and pharmacokinetics of ceftazidime avibactam~     and metronidazole versus meropenem in paediatric population (from 3 months to less than 18~     years of age )with complicated intra-abdominal infections (cIAIs)~   "
83371|NCT02475720|"~     According to the recent report using EGFR tyrosine kinase inhibitors (EGFR-TKI), there is all~     over survival of the EGFR gene mutation-positive NSCLC in a tendency to extension. However,~     the real situation and the reason are not clarified.This observational study collects the~     data of EGFR gene mutation-positive NSCLC approximately 2,000 from the medical record of~     approximately 20 facilities in Japan and observes the treatment reality of EGFR gene~     mutation-positive NSCLC.~   "
83372|NCT02475707|"~     This research study uses special blood cells called multiple tumor-associated antigen~     (TAA)-specific T cells (a new experimental therapy) to treat patients with acute~     lymphoblastic leukemia (ALL) which has come back, or may come back, or has not gone away~     after standard treatment, including an allogeneic hematopoietic stem cell transplant (HSCT).~      The investigators have previously used this sort of therapy to treat Hodgkin or non-Hodgkin~     lymphomas that are infected with Epstein-Barr virus (EBV), the virus that causes infectious~     mononucleosis (mono or the kissing disease), Epstein Barr virus (EBV). EBV is found in~     cancer cells of up to half of all patients with Hodgkin and non-Hodgkin lymphoma. This~     suggests that it may play a role in causing lymphoma. The cancer cells infected by EBV are~     able to hide from the body's immune system and escape being killed. The investigators~     previously tested whether special white blood cells (called T cells) that were trained to~     kill EBV-infected cells could affect these tumors, and in many patients the investigators~     found that giving these trained T cells caused a complete or partial response.~      In several lymphomas and other types of cancers like ALL, the cancer cells do not have EBV.~     They do however express specific proteins that can be targeted in the same way. The~     investigators have been able to infuse such tumor-targeted cells into up to 10 patients with~     lymphoma who do not have EBV, and seen some complete responses. Importantly, the treatment~     appears to be safe. Therefore, the investigators now want to test whether the investigators~     can direct these special T cells against other types of cancers that carry similar proteins~     called tumor-associated antigens (TAAs). These proteins are specific to the leukemia cell, so~     they either do not show up, or show up in low quantities, on normal human cells.~      The investigators will grow T cells from patients' stem cell donors in the laboratory in a~     way that will train them to recognize the tumor proteins WT1, PRAME and Survivin, which are~     expressed on most ALL cancer cells. The cells will be infused at least 30 days~     post-allogeneic stem cell transplant. In this study, the investigators want to see whether~     these cells will be able to recognize and kill leukemia cells that express these antigens.~     These donor-derived multiTAA-specific T cells are an investigational product not yet approved~     by the U.S. Food and Drug Administration.~      The purpose of this study is to find the largest safe dose of donor-derived multiTAA-specific~     T cells for patients with ALL.~   "
83373|NCT02475694|"~     The purpose of the present study is to visualize the inflammatory response and coagulation~     disorders during cardiac surgery in order to identify possible predictors for acute lung~     injury postoperatively.~   "
83374|NCT02475681|"~     This study is evaluating the efficacy of obinutuzumab in combination with chlorambucil~     compared with acalabrutinib in combination with obinutuzumab (Arm B) for the treatment of~     previously untreated chronic lymphocytic leukemia (CLL).~   "
83382|NCT02475577|"~     The study will test a hypothesis that the remote monitoring with text and email alerts sent~     to study subject and optional family/other caregiver (Intervention 1) will have a higher~     return on investment compared to remote monitoring with nurse researcher follow-up telephone~     communication to study subject (on Blue alerts) or study subject's healthcare professional~     (on Red alerts) (Intervention 2) and self-monitoring without intervention (Control).~   "
83383|NCT02475564|"~     This study aims to verify whether the use of 40 mg of resveratrol per day associated with~     monophasic contraceptive pill (levonorgestrel 0.15mg/ethinyl estradiol 0.03mg) reduces pelvic~     pain at the end of 2 months of treatment, compared to the use of the pill with placebo.~   "
83384|NCT02475551|"~     This study will assess the safety and efficacy of IdeS in the transplantation setting. Each~     patient will receive one dose of IdeS. If the crossmatch test is negative at the time of~     transplantation, the patient will be transplanted with a kidney from a deceased or living~     donor. The starting dose will be 0.25 mg/kg BW, given as a single intravenous infusion prior~     to surgery.~   "
83385|NCT02475538|"~     This study aims to examine the efficacy of electroacupuncture for tapering benzodiazepines in~     long-term users. All eligible subjects will be randomized in a ratio of 1:1 to (1)~     Electroacupuncture combined with gradual tapering; and (2) Placebo acupuncture combined with~     gradual tapering.~   "
83386|NCT02475525|"~     The study aims to evaluate the efficacy of an arginine enriched oral nutritional supplement~     in the prevention of wound complications in the the wounds of patients post lower limb~     revascularization.~   "
83387|NCT02475512|"~     Incontinence is a widespread problem in all health care setting. One of the main~     complications of incontinence is inflammation of the skin in the genital and anal region,~     also known as incontinence-associated dermatitis (IAD). IAD is a known risk factor of~     pressure ulcer development. Prevalence figures of IAD vary between 5.6% and 50%.~      The primary aim of this study is to compare the effectiveness of a 3-in-1 genital wipe versus~     standard care (traditional water and soap) for the prevention of IAD. The second aim is to~     perform a health economic evaluation of the 3-in-1 genital wipe versus standard care, and~     third to compare the cost of a 2-in-1 total body wash wipe versus standard care for total~     body wash. Other outcomes are the comfort and tolerance of both the nurses and participants.~      In this Randomized Controlled Trial, performed in 13 long-term care settings, the~     participants will undergo a 30 day study period. In the experimental intervention, the~     participants will be washed with body wash wipes and genital wipes. In the control group, the~     subjects will receive traditional care. IAD as well as Pressure Ulcer prevalence will be~     monitored. Subjective and objective time measurements will be performed.~   "
83388|NCT02475499|"~     The purpose of this study is to determine whether incretin-based drugs (used to treat type 2~     diabetes) taken either alone in or combination with other anti-diabetic drugs are associated~     with an increased risk of pancreatic cancer (PC) compared to sulfonylureas.~      The investigators will carry out separate population based cohort studies using~     administrative health databases in five jurisdictions in Canada, the US, and the UK. Cohorts~     will be defined by the initiation of a new anti-diabetic drug when incretin-based drugs~     entered the market, with follow-up until hospitalization for PC. The results from the~     separate sites will be combined to provide an overall assessment of the risk of PC in users~     of incretin-based drugs and by class of incretin-based drugs.~   "
83389|NCT02475486|"~     Despite the large therapeutic arsenal available since one decade allowing a strong reduction~     of inflammation process, rheumatoid arthritis (RA) patients claimed pain, fatigue, sleep~     problems and other quality of life outcomes. Fatigue reduction during TNF blockers therapy is~     lower than the strong reduction in RA disease activity. Furthermore, RA patients have higher~     prevalence of non-inflammatory pain than general population. Fatigue is a real major problem~     due to 50% of patients considered it as severe.~      This dissociation between disease activity and fatigue level suggests that fatigue is~     multifactorial. No consistent explanations for fatigue are currently available.~   "
83390|NCT02475473|"~     Study the responses of circulatory irisin to chronic high-intensity resistance training~   "
83391|NCT02475460|"~     The purpose of this study is to evaluate a less invasive implantation technique of the~     HeartMate 3 Left Ventricular Assist System (HM 3 LVAS) in 10 patients.~   "
83392|NCT02475447|"~     Kappa-opioid receptors mediate the sensation of itch in animals and humans. Asimadoline is an~     orally active, selective kappa-opioid receptor agonist and has demonstrated efficacy in~     several preclinical pruritus models. The purpose of this Phase 2 study is to evaluate the~     safety, tolerability and clinical efficacy of asimadoline in patients with pruritus~     associated with atopic dermatitis.~   "
83393|NCT02475434|"~     At present, widespread use of the human milk-based caloric supplement (cream) has not~     occurred, particularly in infants with bronchopulmonary dysplasia (BPD), and further data are~     needed to support its adoption as a standard care practice.~      The investigators hypothesize that infants who receive an exclusive human milk (HM)-based~     diet with the addition of a HM-derived cream caloric supplement (Cream group) will have a~     shorter length of initial hospital stay compared to infants receiving the standard regimen of~     an exclusive HM-based diet (Control group). The investigators hypothesize that the effects of~     the cream caloric supplement will be greater in the subgroup of infants who develop BPD so~     the relationship will be evaluated between Cream Supplement study group and postmenstrual age~     (PMA) at discharge and the incidence of BPD.~   "
83394|NCT02475421|"~     The study aims to evaluate the elimination and degradation of glucagon in patients with type~     2 diabetes compared to matched healthy subjects.~   "
83408|NCT02475239|"~     The standard treatment of posterior semicircular canal benign paroxysmal positional vertigo~     is the canalith repositioning procedure or the Epley maneuver. Based on the present~     literature, there is controversy on the efficacy of post-maneuver postural restrictions.The~     aim of this study was to conduct a randomized controlled trial to compare the treatment~     efficacy of post-maneuver postural restriction with CRP alone in patients with posterior~     semicircular canal benign paroxysmal positional vertigo.~   "
83409|NCT02475226|"~     Cases of traumatic and nontraumatic brain damage have high rates of morbidity and mortality.~     In this study of cases being treated in the ICU for a diagnosis of brain damage, it was aimed~     to evaluate the relationship between mortality and the distribution of reason for and~     resulting type of brain damage and to determine other factors affecting mortality.~   "
83395|NCT02475408|"~     Coronary artery disease and the benefit of bypasses:~      Despite considerable advances in medicine, cardiovascular diseases remain the number one~     cause of death globally, primarily consequence of myocardial infarction (MI). Coronary~     collaterals exert a protective effect by providing an alternative source of blood flow to a~     myocardial territory potentially affected by an acute coronary occlusion. Coronary~     collaterals represent pre-existing inter-arterial anastomoses and as such are the natural~     counter-part of surgically created bypasses. Sufficient coronary collaterals have been shown~     to confer a significant benefit in terms of overall mortality and cardiovascular events. In~     this regard, the concept of augmenting coronary collateral function as an alternative~     treatment strategy to alter the course of CAD, as well as to control symptoms, is attractive.~      Durable promotion of coronary collateral circulation:~      Before the advent of coronary artery bypass grafting, permanent augmentation of coronary~     collateral supply by a single structural modification has already been attempted. Bilateral~     ligation of the internal mammary arteries (IMA) was performed in CAD patients to alleviate~     angina pectoris and electrocardiographic (ECG) signs of ischemia. The prevalent in vivo~     function of natural IMA-to-coronary artery bypasses and their anti-ischemic effect has - for~     the first time - been recently demonstrated by our research group. The acute functional~     changes observed in response to temporary distal IMA balloon occlusion are expected to result~     in larger chronic structural adaptations of the IMA-to-coronary-artery connections when the~     distal IMA is permanently occluded. In contrast to the previously employed arteriogenic~     approaches in humans, the attractiveness of such an intervention lies in the potential~     durability of the effect.~      In a first step, catheter-based IMA occlusion ought to be conceptually investigated in the~     setting of the less frequently grafted right IMA among patients with ischemia in the right~     coronary artery territory.~   "
83396|NCT02475395|"~     The objective of the study is to evaluate the agreement in measurement of sperm concentration~     in human semen between lay users with TRAK and a recognized reference method. The study will~     also include the measurement of matched samples by TRAK when tested by healthcare~     professionals trained in use of the TRAK device.~   "
83397|NCT02475382|"~     The purpose of this study is to provide treatment with nivolumab, a fully human monoclonal~     antibody, to subjects who have relapsed after treatment with a minimum of 1 prior systemic~     treatment for advanced or metastatic squamous (Sq) or non-squamous (non-Sq) non-small cell~     lung cancer (NSCLC) , Stage IIIB/IV and whose physicians believe that nivolumab treatment is~     appropriate.~   "
83398|NCT02475369|"~     The purpose of this protocol is to conduct a pilot study to investigate whether pancreatic~     enzyme supplementation will improve symptoms in individuals with celiac disease who suffer~     persistent symptoms despite a gluten free diet. This protocol specifically aims to:~        1. Evaluate the efficacy of pancreatic enzyme supplementation for reduction of~          gastrointestinal symptoms in patients with celiac disease on a gluten free diet.~        2. Assess the ability of fecal elastase levels to predict response to pancreatic enzyme~          supplementation in patients with celiac disease on a gluten free diet.~   "
83399|NCT02475356|"~     The primary objective in this study is collecting post-marketing information on the safety.~     Thus, it includes information under the routine clinical practice on adverse events (AEs) and~     adverse drug reactions (ADRs) including expulsion and abnormal bleeding that occur within the~     first 12 months Mirena insertion.~      The secondary objective(s) in this study is/are collecting information on Mirena~     effectiveness, such as periodic blood loss and Quality of life (QOL), use of analgesic and~     dysmenorrhea pain as far as these are recorded under routine clinical practice.~   "
83400|NCT02475343|"~     This study aims to use Schiotz tonometer to evaluate the corneal biomechanical properties.~     The administration of Schiotz tonometer is according to the routine protocol which is use to~     measure intra-ocular pressure. The results obtained from Schiotz tonometer will be compared~     with results obtained from ORA and/or Corvis.~   "
83401|NCT02475330|"~     This single arm Phase II trial will investigate the feasibility of dietary flaxseed (FS)~     supplementation in subjects receiving definitive chemoradiotherapy for non-small cell lung~     cancer (NSCLC). Subjects will ingest FS for a period of approximately 8 to 9 weeks during the~     course of radiation treatment. Study participation and surveillance will last approximately 6~     months. Subject specimen collection will include: blood, urine, and buccal swabs at 5 time~     points.~   "
83402|NCT02475317|"~     The purpose of this study is to assess the relative potency of multiple oral doses of LUM001~     and SHP626 administered for 7 days as assessed by fecal bile acid excretion in overweight and~     obese adult subjects. This study is designed to address the relative potency question for the~     first time in the same.~   "
83403|NCT02475304|"~     The purpose of this study is to investigate, whether FP187 is effective in the treatment of~     mild to moderate psoriatic arthritis.~   "
83404|NCT02475291|"~     Fractional flow reserve (FFR) is a pressure-wire-based index that is used during coronary~     angiography to assess the potential of a coronary stenosis to induce myocardial ischemia.~     Recent ESC guidelines referred to the usefulness of FFR extensively when noninvasive stress~     imaging is contraindicated, non-diagnostic, or unavailable. However, FFR requires additional~     manipulation with maximal and stable hyperemia by intravenous adenosine. More routine use of~     FFR for all angiographically significant stenoses would add considerable time, cost, and~     complexity to each PCI procedure and might also increase the risk of catheter-related~     complications such as coronary dissection and perforation. Although the guideline mentioned~     that FFR may not be useful in very high grade lesions (angiographically >90%) which always~     have an FFR <0.80, it have not been revealed yet proper criteria to predict FFR <0.80~     obtained by angiographic parameters including degree of stenosis, lesion location and vessel~     size. It would be valuable to find more precise criteria available by conventional~     angiography for discrimination of functional stenosis in way to reduce the risk of additional~     procedure. For the purpose, the investigators will perform FFR in the lesions with~     significant stenosis (>70% diameter stenosis by visual estimation) and compare the~     angiographic parameters and FFR values in the study.~   "
83405|NCT02475278|"~     The purpose of this study is to collect serum samples to evaluate serologic assays and to~     establish proficiency panels for serologic assays used for assessment of post vaccination~     immune response after intramuscular (IM) vaccination with Norovirus GI.1/GII.4 bivalent~     virus-like particle (VLP) vaccine.~   "
83406|NCT02475265|"~     Decreased bone strength is a common and serious medical problem present in many women with~     anorexia nervosa. Women with decreased bone strength are more likely to suffer broken bones~     than women with normal bone strength.~      This study will investigate whether the use of transdermal estrogen can improve bone mineral~     density (BMD) and bone microarchitecture in women with anorexia nervosa anorexia nervosa when~     used for 6 months.~   "
83425|NCT02475018|"~     The purpose of this study is to determine whether YiLi Xinhuo Shuhua Milk is effective in~     reducing the serum cholesterol in human with hypercholesterolemia.~   "
83426|NCT02475005|"~     The purpose of this study is to test the efficacy of a new app to help adolescents with~     chronic or reoccurring headaches self manage pain.~   "
83410|NCT02475213|"~     The purpose of this study is to evaluate the safety of enoblituzumab (MGA271) in combination~     with Keytruda (pembrolizumab) when given to patients with B7-H3-expressing melanoma, squamous~     cell carcinoma of the head and neck (SCCHN), non small cell lung cancer (NSCLC), Urothelial~     Cancer and other B7-H3 expressing cancers. The study will also evaluate what is the highest~     dose of enoblituzumab that can be given safely when given with pembrolizumab. Assessments~     will also be done to see how the drug acts in the body (pharmacokinetics (PK),~     pharmacodynamics) and to evaluate potential anti-tumor activity of MGA271 in combination with~     pembrolizumab.~   "
83411|NCT02475200|"~     The Phoenix Post-Approval Registry is a prospective, multi-center, single arm registry~     sponsored by Volcano Corporation to evaluate the short and long term performance and clinical~     outcomes of the Phoenix Atherectomy System.~   "
83412|NCT02475187|"~     Measurement of thrombogenic properties by TEG and MEA and observation of thrombotic events~     over 2 years in 220 patients with hip fracture.~   "
83413|NCT02475174|"~     Evaluate the effect of Manual Lymphatic Drainage (MLD) massage in arterial and venous~     circulation of the upper limb ipsilateral of women submitted after axillary lymphadenectomy~     breast cancer.~   "
83414|NCT02475161|"~     The purpose of this study is to assess the effects of daily administration of rabeprazole on~     the single-dose pharmacokinetics of JNJ-42847922 in healthy participants.~   "
83415|NCT02475148|"~     The purpose of this study is to investigate the safety and tolerability of JNJ-54175446~     versus placebo after single oral dose administration (ascending dose levels), to determine~     the maximal tolerated dose (MTD) or the safety and tolerability at exposures resulting in~     full target engagement for at least 24 hours in all participants (whichever comes first), to~     characterize the pharmacokinetics of JNJ-54175446 in plasma, cerebrospinal fluid (CSF) and~     urine and to investigate the effect of food (high fat/high calorie) on the pharmacokinetics~     of JNJ 54175446 after single oral dose administration.~   "
83416|NCT02475135|"~     The purpose of this study is to evaluate the pharmacokinetics and relative bioavailability of~     Emtricitabine (FTC) and Tenofovir alafenamide (TAF) when administered as a fixed-dose~     combination (FDC) with darunavir (DRV) and cobicistat (COBI)~     (darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) relative to~     administration as an FDC with Elvitegravir (EVG) and COBI~     (Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide), under fed conditions in~     healthy subjects (Panel 1); evaluate the single-dose pharmacokinetics and relative~     bioavailability of DRV, COBI, FTC and TAF when administered as an FDC (D/C/F/TAF) or as~     separate agents (D+C+FTC/TAF), under fed conditions in healthy subjects (Panel 2) and to~     evaluate the impact of food (fasting or high-fat breakfast) on the single-dose~     pharmacokinetics of DRV, COBI, FTC, and TAF when administered as an FDC (D/C/F/TAF) in~     healthy subjects (Panel 3).~   "
83417|NCT02475122|"~     Portal hypertension (PHT) that leads to esophageal varices is clinically present, at the time~     of diagnosis, in 60% of cirrhotic patients (Groszmann NEJM 2005). Variceal bleeding is a~     life-threatening complication. The yearly incidence of the first variceal bleeding in~     cirrhotic patients is estimated to 4%. This risk increases to 15% when medium or large~     varices are initially present, (D'amico Baillieres Clin Gastroenterol 1997); Therefore, for~     patient with medium or large varices a primary prophylaxis treatment with nonselective~     beta-blockers must be instituted decreasing risk of bleeding approximately by half (d'amico~     Hepatology 2005).~      The method to evaluate the efficacy of beta blockers treatment is the hepatic venous pressure~     gradient (HVPG). HVPG < 12 mmHg or a decrease of HVPG of 20% after beta blocker treatment~     reduce dramatically the risk of bleeding (Feu F. Lancet 1995). But a good response (HVPG < 12~     mmHg or reduction > 20%) to beta blockers was observed only in almost 30 % of patients. In~     non responder patients, the variceal bleeding incidence is estimated to 24 % at 2 years.~      In this situation, alternative treatments to beta-blockers have been suggested: endoscopic~     ligation, which was shown to be as effective as beta blockers in primary prevention, and more~     recently carvedilol (Reiberger, Gut 2012).~      So, HVPG monitoring may provide critical information for patients. However, because of its~     technical requirement and its invasivity, HVPG measurement is not feasible in clinical~     practice . So, there is a general consensus to continue indefinitely beta blockers treatment~     without control of hemodynamic efficiency (merkel J. Hepatology 2009).~      Previous studies have suggested the interest of azygos blood flow measurements for evaluating~     hemodynamic changes in the esophageal collateral vessels of patients with portal hypertension~     (Bosch J. Hepatology 1985 ). More recently Magnetic Resonance Imaging (MRI) has been reported~     to be an efficient technique to assess azygos blood flow (Gouya Radiology 2011) in cirrhotic~     patients. Its feasibility is obviously higher than HVPG measurement.~      However, in the same way that HVPG, a large-scale implementation in clinical practice of~     azygos blood flow measurement by MRI requires to specify minimal absolute threshold, or~     relative post-therapeutic decrease, related with no variceal bleeding.~   "
83418|NCT02475109|"~     The objective of this study is to assess the safety and tolerability of topical ocular~     PAN-90806 in patients with proliferative diabetic retinopathy.~   "
83419|NCT02475096|"~     This pilot-study aims to evaluate the effect size and feasibility of internet-delivered~     cognitive behavior therapy (ICBT) for children (age 8-12 years) with pain-predominant~     functional gastrointestinal disorders (e.g. irritable bowel syndrome, functional abdominal~     pain and functional dyspepsia according to the Rome III criteria). The main component~     investigated in this study is exposure for gastrointestinal symptoms and for feared stimuli~     and situations. Children will participate along with one of their parents in the treatment.~     The parents will also receive specific modules with information on how to support their child~     in the treatment.~   "
83420|NCT02475083|"~     The aim of this study was to investigate the therapeutic effect of virtual reality associated~     with conventional physiotherapy on balance during gait and the occurrence of falls in~     patients after stroke.~   "
83421|NCT02475070|"~     The aim of the study is to assess if vildagliptin and dapagliflozin have dissociated effects~     on glucagon secretion after a mixed meal ingestion in metformin-treated subjects with type 2~     diabetes and whether this is associated with effects on glucose homeostasis.~   "
83422|NCT02475057|"~     The purpose of this study is to test whether Degarelix is associated with less endothelial~     dysfunction (an intermediate in the development of cardiac disease) and cardiovascular~     biomarkers compared to LHRH agonists.~   "
83423|NCT02475044|"~     The purpose of this study is to investigate the role of psychosocial factors in creating~     Persistent Post-concussive symptoms (PPCS). The researchers investigate three hypotheses: (a)~     Do pre-injury psycho-environmental deficits predict a higher level of PPCS? (b) Do~     socio-demographic and personal pre-injury deficits relate to (1) a more negative attribution~     for the child injury by their parents and (2) embracing of a more permissive and~     authoritarian parenting; and do these factors mediate the symptoms' preservation? (c) Does~     Cognitive-Behavioral Therapy (CBT) benefit to reducing PPCS emotional and behavioral~     symptoms?~   "
83424|NCT02475031|"~     The purpose of this study is to determine whether continuous transversus abdominis plane~     (TAP) block is superior to single shot TAP for postoperative pain after laparoscopic donor~     nephrectomy~   "
83427|NCT02474992|"~     The purpose of this randomized controlled trial is to compare a social network-based~     behavioral intervention known as microclinics to standard HIV clinical care alone in helping~     patients receiving HIV care on Mfangano, Remba and Ringiti Islands, Kenya remain adherent to~     clinic appointments. The study is designed to evaluate the effectiveness of microclinics on~     reducing gaps in clinical care, HIV viral load and HIV-related stigma, compared to standard~     HIV clinical care alone. By doing this research study, the investigators hope to learn~     whether microclinics are a useful social strategy for improving delivery of HIV treatment in~     rural Kenya.~   "
83428|NCT02474979|"~     Pressure ulcers (PU) cause pain and discomfort to affected patients, as well as considerable~     costs for society. The present study will evaluate the effect of the Continuous Bedside~     Pressure Mapping (CBPM)- system on PU prevalence and incidence. A RCT including 180 patients~     will be conducted in a geriatric setting in a Swedish University hospital~   "
83429|NCT02474966|"~     The blood-brain barrier (BBB) is a specialized interface allowing a unique environment for~     neuro-glia networks. BBB dysfunction is common in brain disorders. The Transcranial Magnetic~     Stimulation (TMS) is a non-invasive method of stimulating cortical motor neurons with the use~     of rapidly changing electromagnetic fields generated by a coil placed over the scalp. The~     objective of this study is to evaluate the safety and effects of the deep TMS (dTMS) on~     barrier integrity in patients with malignant glial tumors. BBB permeability will be~     quantified using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI). Permeability~     change will be compared between two DCE-MRI scans performed immediately after real and~     sham rTMS, randomly assigned within one week of each other.~   "
83430|NCT02474953|"~     This study is investigating the pharmacokinetic profile (i.e. the way the product is~     processed by the body) of a proprietary curcumin formulation compared to an unformulated~     curcumin product. Subjects will take a single dose of either the proprietary formulation or~     comparator product and the blood levels of curcumin and curcumin metabolites will be measured~     over a period of 48 hours.~   "
83431|NCT02474940|"~     People with Multiple Sclerosis (MS) often have pain and/or fatigue. Unfortunately, available~     treatments provide inadequate relief for the majority of these individuals. There remains an~     urgent need for additional treatment options for MS-related symptoms. The purpose of this~     study is to see if alternative treatments that involve self-hypnosis training, neurofeedback~     training and/or mindfulness meditation training, or a combination of some of these treatments~     can help decrease pain and fatigue in people with MS. A subject must have a diagnosis of MS,~     have chronic pain and/or fatigue, and be at least 18 years old to participate, among other~     criteria.~   "
83432|NCT02474927|"~     The clinical trial is a Phase II open label, single-arm pilot study to evaluate the safety~     and efficacy of combination therapy with carfilzomib, plasma exchange and intravenous~     immunoglobulins for AMR after lung transplantation and elucidate important clinical and~     immunologic phenotypes and mechanisms associated with these outcomes.~   "
83433|NCT02474914|"~     pancreaticoduodenectomy (PD) is the standard operation for treatment of patients with benign~     and malignant pancreatic and periampullary diseases. Despite improved surgical technique and~     postoperative care, the mortality rate after PD is high reaching up to 30%, due to high~     incidence of postoperative complications . Pancreatic fistula (PF) is the one of the most~     frequent complications of PD and the major contributor to postoperative morbidity The aim of~     this study to evaluate the effect of the perioperative octreotide use after PD for prevention~     of the postoperative pancreatic fistula. The secondary outcomes are overall postoperative~     complications, mortality and the cost benefit relationship of the use of the perioperative~     octreotide.~   "
83434|NCT02474901|"~     The goal of this study is to determine if there is a difference in shedding (primary~     objective) and in immunogenicity and safety (secondary objectives) between HIV-positive and~     HIV-negative children and young adults who are receiving the quadrivalent live-attenuated~     influenza vaccine (QLAIV).~   "
83435|NCT02474888|"~     The aim of the investigators' study is to evaluate whether monitoring serum rituximab levels~     could be an interesting tool in the follow-up of ANCA-associated vasculitis patients.~      All consecutive patients, hospitalized for a new diagnosis of ANCA-associated vasculitis or~     the relapse of a known ANCA-associated vasculitis, in which the decision to start an~     induction regimen with rituximab has been taken, will be included.~      Serum rituximab levels (along with serum anti-rituximab antibodies levels) will be determined~     (at M+1 and M+3) and the correlation with clinical outcome at M+6 will be analyzed.~   "
83436|NCT02474875|"~     Education of pain physiology is described as an educational session or sessions describing~     the neurobiology and neurophysiology of pain, and pain processing by the nervous system.~     There is compelling evidence that an educational strategy addressing neurophysiology and~     neurobiology of pain can have a positive effect on pain, disability, catastrophization, and~     physical performance in chronic musculoskeletal pain disorders. Although pain physiology~     education has been studied in patients with chronic low back pain, chronic whiplash, and~     chronic fatigue syndrome in combination with widespread pain, studies in fibromyalgia (FM)~     are limited to a 2013 study with limited results.~      The investigators propose a study with a higher dose of education of pain physiology (i.e. a~     higher number of educational sessions and total education time) to study if this generates a~     larger treatment effect in patients with fibromyalgia.~   "
83437|NCT02474862|"~     This study is a randomized control trial (RCT) evaluating a Prenatal Walking Program (PWP) in~     comparison to a Postpartum Prep Program (PPP) comparison group for pregnant women~     experiencing depressive symptoms. In addition to assessing changes in depressive symptoms,~     the investigators will examine other key maternal outcomes (maternal functioning, pain,~     anxiety, stress, fatigue), as well as infant outcomes including birth record data (gestation,~     weight, Apgar scores, etc) and careful, in-person assessment of infant neurobiological~     functioning at 30 days postpartum.~   "
83438|NCT02474849|"~     This study will compare nicotine delivery, heart rate, puffing parameters and product~     satisfaction in healthy subjects either using several different types of electronic~     cigarettes or smoking a conventional cigarette.~   "
83458|NCT02474550|"~     This study was designed to review clincal outcomes of Diffuse Large B Cell Lymphoma (DLBCL)~     treated with R-CHOP chemotherapy in the era of pegylated-filgrastim. The investigators will~     prospectively collect clinical data and treatment outcome of patients with DLBCL who use~     prophylactic pegylated-filgrastim.~   "
83439|NCT02474836|"~     Allergen extracts are complex mixtures of proteins and contain varying amounts of allergenic~     and non-allergenic components. Many factors such as the variability, differences in~     extraction process and subsequent handling of allergens can affect the final composition,~     potency, and stability of allergen preparations. Genetic diversity of affected people adds~     another level of complexity. In order to control variability and to achieve consistency and~     reproducibility for optimal safety and sensitivity/specificity, it is essential to~     standardize the amount of allergen used in prick tests. Therefore, the system for biological~     standardization mainly used in Europe still is the biological calibration of in-House~     Reference Preparations (IHRP). The method has been adopted by the Nordic Council on Medicines~     as the Nordic Biological Unit, Histamine Equivalent Potency (HEP) or Skin Prick Test (SPT)~     value. The aim of this procedure is to estimate the biological activity of allergen extracts.~     The activity of an allergen extract is defined as 1 SPT per ml, when the extract provokes a~     specific skin reaction with a wheal of the same size as a wheal provoked by reference~     histamine at a concentration of 10 mg/ml, when both solutions are administrated using the~     same technique (prick testing) on at least 20 individuals who are sensitized to the allergen~     concerned.~      The present study aims to standardize the allergen extracts of Artemisia vulgaris, Platanus~     acerifolia, Dermatophagoides farinae by using this method.~   "
83440|NCT02474823|"~     A previous pilot study on the use of self neck grasp, ESAP (Easy Sleep Apnea Predictor),~     showed a positive maneuver (unable to wrap hands completely around neck) to be 100%~     predictive of sleep apnea in a sleep clinic population. The investigators now would like to~     compare ESAP to other tests used to diagnose and screen for Sleep Apnea in type 2 diabetics.~     The tests will included Home Sleep Testing, sleep questionnaires Berlin and STOP-BANG and~     polysomnogram (PSG). Patients with type 2 diabetes in the Bassett Endocrine Clinic who are~     scheduled for a routine evaluation will be recruited to undergo; a Home Sleep Test along with~     two sleep questionnaires PSG. The screen test wil be compared to the results of the gold~     standard diagnostic test the PSG for their predictive value os OSA in the type 2 diabetic~     population.~   "
83441|NCT02474810|"~     Central venous catheters (CVCs) are used for vascular access by approximately 56% of our 380~     hemodialysis (HD) patients at the Capital Health Renal Program. The major complication of~     these catheters includes thrombosis and infection. Catheter locking solutions such as~     recombinant tissue plasminogen activator (rt-PA), Alteplase (Cathflo®) are used to treat and~     prevent clotting of the catheter during HD treatments and during the interdialytic period.~     Evidence to guide the use of rt-PA is limited. This quality assurance project will compare~     the effectiveness and cost of an intensive versus a standard catheter dysfunction protocol~     for rt-PA in HD patients.~   "
83442|NCT02474797|"~     Diaphragmatic dysfunction is associated with sepsis severity and pejorative prognosis. Aim of~     this study is to assess diaphragmatic function with the Diaphragmatic Thickening Fraction~     (DTF) ultrasound measure in patients with severe sepsis or septic shock, mechanically~     ventilated or not, hospitalized in ICU in order to determinate diaphragmatic dysfunction~     frequency, its prognosis value and its associated factors.~      This is a prospective pilot study in a 14-bed medical and surgical ICU including 50~     consecutive patients with severe sepsis or septic shock. The expected duration of study is 18~     months.~      DTF is measured each day as follow: the probe is placed in an intercostal space between mid~     axillary line and anterior axillary line, 0.5cm to 2 centimeters below the costodiaphragmatic~     sinus. DTF measure is performed in B-mode using the following formula: TF (%) =~     [(end-inspiration thickness - end-expiration thickness)/(end-expiration thickness) x 100]. A~     DTF < 20% indicates a diaphragmatic dysfunction.~      The investigators will collect potential factors for which DTF Ultrasound Measure could have~     a prognosis value (intubation, successful or failed weaning from mechanical ventilation),~     potential risk factors (age, sex, tobacco, alcohol etc.) and potentials associated factors.~      The investigators expect measure of DTF allows identifying patient with severe sepsis or~     septic shock with diaphragmatic dysfunction. It would also estimate diaphragmatic dysfunction~     frequency with ultrasound measure and warranting its use routinely at the bedside. The~     investigators expect that DTF helps to characterize degree of severity of septic patient and~     can be a new index able to predict intubation in this population.~   "
83443|NCT02474745|"~     The objective of this randomized clinical trial is to assess and compare the effectiveness of~     directed closed-glottis (Valsalva) pushing (pushing while holding one's breath) vs. directed~     open-glottis pushing (pushing during a prolonged exhalation) during the second stage of~     labor. The study hypothesis is that open-glottis pushing results in better maternal and~     neonatal outcomes, in particular for maternal pelvic floor and continence function.~   "
83444|NCT02474732|"~     FDA requires that the user's guide be provided with any over-the-counter (OTC) medical~     device. It is beneficial to demonstrate that the user's guide for a new medical device is~     broadly comprehensible where the device will be provided without prescription and direct~     physician counseling. Therefore, a population of subjects will be tested to determine whether~     they can properly use the BeActive Brace device after reading the user's guide.~   "
83445|NCT02474719|"~     The aim of this study is to demonstrate the efficiency of an adapted and alternate~     peritoneal dialysis scheme in terms of sodium extraction and purification compared to an~     adapted conventional peritoneal dialysis scheme.~   "
83459|NCT02474537|"~     This is a phase I, multi-center, open-label, single oral dose, parallel group study to~     evaluate the pharmacokinetics and safety of INC280 in non-cancer subjects with impaired~     hepatic function and non-cancer subjects with normal hepatic function.The study population~     will be healthy male and postmenopausal or sterile female subjects who meet all of the~     inclusion and none of the exclusion criteria. Subjects will be assigned to groups according~     to their hepatic function: normal (Group 1), mild (Group 2), moderate (Group 3), and severe~     (Group 4) impairment. This study consists of a two-staged design with interim analysis. In~     Stage 1, subjects in Groups 1, 2 and 3 will be enrolled. Upon completion of Stage 1, an~     interim analysis will be conducted. Depending on the results of the analysis, either the~     study will conclude with no further enrollment or Stage 2 will commence with enrollment of~     Group 4.~      A minimum of 6 evaluable subjects per group will be enrolled.Once enrolled in the study,~     participants will be confined to the facility for 4 days, given a single dose of INC280 and~     monitored for pharmacokinetic and safety assessments.~   "
83446|NCT02474706|"~     Background Information: Infections caused by extended-spectrum β-lactamase (ESBL)-producing~     Escherichia coli are becoming increasingly common owing to incorrect use of antibiotics and~     cross-transmission in healthcare establishments. These give rise to major problems in~     standard clinical practice: penicillins and cephalosporins cannot be used, and resistance to~     the other classes of antibiotics normally used, such as fluoroquinolones or cotrimoxazole, is~     very frequently observed. The current therapeutic strategy involves the use of a carbapenem,~     which represents the last effective solution on an individual level. However, the growing use~     thereof is contributing, collectively, to the development of resistance due to the production~     of carbapenemases, which will become a major public health problem, with a potential~     therapeutic dead-end. This observation is particularly worrying due to the very small number~     of antibiotic agents currently in development.~      Infectious disease specialists and microbiologists are thus examining alternative agents to~     carbapenems in the management of infections caused by ESBL-producing E. coli. One of the~     avenues which could be developed is the use of known agents, already on the market, which are~     active in vitro on ESBL-producing E. coli, but which are not currently recommended for this~     indication in standard practice due to the lack of conclusive studies. Cefoxitin, an~     antibiotic belonging to the cephamycin group, could thus represent an alternative of~     particular interest in the treatment of infections caused by ESBL-producing E. coli, and help~     limit the use of carbapenems.~      The implementation of a prospective, randomized, non-inferiority study on ertapenem and~     cefoxitin is of the most interest from a methodological perspective. It will enable~     recommendations to be drawn up, with a high level of evidence, very long-awaited in the~     field.~      Primary objective: To evaluate the bacteriological non-inferiority of cefoxitin versus~     imipenem in the treatment of non-severe urinary tract infections (other than cystitis) caused~     by ESBL-producing E. coli susceptible in vitro to cefoxitin.~      Secondary objectives:~        -  To evaluate the clinical non-inferiority of cefoxitin versus imipenem in the treatment~          of non-severe urinary tract infections (other than cystitis) caused by ESBL-producing E.~          coli susceptible in vitro to cefoxitin.~        -  To evaluate the impact of cefoxitin and imipenem on the emergence of multiresistant~          bacteria in the gut flora.~   "
83447|NCT02474693|"~     The Centers for Disease Control and Prevention conducted an observational cross-sectional~     study to obtain information about the amount of sodium consumed from various sources~     (including sodium from processed and restaurant foods, sodium inherent in foods, and salt~     added at the table and during cooking) and to examine variability across population~     subgroups. Data collection will include an observational component as well as a sub-study~     designed to refine the accuracy of estimates of total sodium intake and discretionary sodium~     intake.~      Information was collected in three distinct geographic regions: 1) Minneapolis/St. Paul,~     Minnesota, 2) Birmingham, Alabama, and 3) Palo Alto, California. Over a two-year period, a~     study center in each location recruited 150 participants (total N=450). Overall, an~     approximately equal number of adults ages 18-74 years by approximately 10-year age groups in~     each sex-race group, including whites, blacks, Hispanics, and Asians. A sub-study was~     conducted among a subgroup of 150 of these participants (50 per site). University of~     Minnesota serves as a study coordinating center.~   "
83448|NCT02474680|"~     This is a non-randomized, single-case design of pharmacogenetic implementation in a mental~     health patient population of subjects taking antipsychotics and/or antidepressants.~   "
83449|NCT02474667|"~     A Multicenter, Prospective, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study of~     BB3 to Reduce the Severity of Delayed Graft Function in Recipients of a Deceased Donor~     Kidney.~      The major objective is to demonstrate the safety and efficacy of BB3 in reducing the severity~     of delayed graft function (DGF) in recipients at high risk of DGF after receiving a deceased~     donor renal allograft.~   "
83450|NCT02474654|"~     Study question: Is there an ideal combination of intraoperative long acting analgesics~     (periarticular infiltration (PI), femoral nerve block (FB) and intrathecal opioids (IO)) to~     optimize post-operative functional recovery, decrease overall narcotic consumption and enable~     faster 'readiness to discharge' for patients undergoing primary total knee replacement (TKR)?~   "
83451|NCT02474641|"~     Hypofractionation with simultaneous integrated boost has been investigated in a few trials~     and appears to be safe and feasible.~      Investigators initiated this multicenter two-armed phase III prospective trial to analyse the~     non-inferiority of hypofractionation with simultaneous integrated boost in patients with~     early breast cancer in comparison to standard fractionation.~   "
83452|NCT02474628|"~     Intervention studies do not account for high within-individual variation potentially~     compromising the magnitude of an effect. Repeat administration of a treatment allows~     quantification of individual responses and determination of the consistency of responses. The~     investigators aim to determine the consistency of metabolic and exercise responses following~     repeated administration of sodium bicarbonate (SB). Design and Methods: 15 physically active~     males will complete six cycling capacity tests at 110% of maximum power output (CCT110%)~     following ingestion of either 0.3 g∙kg-1Body Mass of SB (4 trials) or placebo (PL, 2 trials).~     Blood pH, bicarbonate, base excess and lactate will be determined at baseline, pre-exercise,~     post-exercise and 5-min post-exercise. Total work done (TWD) will be recorded as the exercise~     outcome.~   "
83453|NCT02474615|"~     Thirty teeth twelve patients, two female and a male, who had persistent periradicular lesions~     were selected to participate in this study. The lesions were diagnosed with cone-beam~     computed tomography (cone-beam CT; Model i-Cat 17-19, Imaging Sciences International LLC).In~     patients with two teeth to be treated, a tooth was retroobturado with PBEA cement,~     (experiment) and another tooth was retroobturado with MTA cement (control).~      There was significance for the two cements on the repair of wounds. Key words: Apicoectomy;~     Oral Surgery; Biocompatible Materials; Dental Cements; Translational Medical Research~   "
83454|NCT02474602|"~     The effects of phototherapy has been widely studied by some research groups. The~     investigators know that there are positive results with light application to improve muscle~     performance and delay fatigue. However, there are few studies showing its´ effects on~     muscular training. Therefore, the aim of this study was to assess the effects of phototherapy~     applied at different times during 12 weeks of strength training. For such, 48 volunteers,~     healthy male, from 18 to 35 years old were recruited to perform a strength training protocol~     for the anterior muscle of the thigh development. Volunteers performed the training protocol~     twice a week for 12 weeks. There were assessed isometric peak torque in isokinetic~     dynamometer, 1-repetition maximum test in the leg extension and leg press machines and~     bilateral thigh perimetry.~   "
83455|NCT02474589|"~     Multicenter, double-blind, placebo controlled, Phase 3 study to determine the safety and~     tolerability of oral tecovirimat, an anti orthopoxvirus compound, in subjects.~   "
83456|NCT02474576|"~     The efficiency of percutaneous aponeurotomy in the treatment of Dupuytrens disease is well~     known. However, the duration of the clinical improvement after aponeurotomy is not well~     known.~      This study aims primarily at measuring the incidence rate of local relapse of~     Dupuytrens-induced finger flessum, within two years following treatment by percutaneous~     aponeurotomy in Dupuytrens.~   "
83457|NCT02474563|"~     The purpose of this study is to assess the 2-year progression-free survival rate.~   "
83460|NCT02474524|"~     This project is a component of a broader research program referred to as Self-Management and~     Recovery Technology (SMART): Use of online technology to promote self-management and recovery~     in people with psychosis, which has been funded by the Victorian Department of Health Mental~     Illness Research Fund (MIRF33). The overall research program is examining the therapeutic~     potential of using online (Internet-based) educational and multimedia resources in mental~     health services. It involves the development of a website which can be accessed via an~     internet browser on a desktop computer, tablet computer, or smartphone. It consists of a~     series of educational modules containing textual information, exercises, audio, and video~     clips designed to promote self-management and recovery in people with a history of persisting~     mental illness.~      This particular project (SMART-Therapy) involves a randomised controlled trial examining the~     use of a discrete 8-session psychosocial intervention delivered in addition to routine care~     which utilises these online materials. The intervention will involve a mental health worker~     meeting with the participant with a tablet computer (e.g. iPad) on which online materials can~     be viewed, and used to guide an interaction with the participant.~      The randomised controlled trial will include 148 participants, who will be randomised to~     receive one of two interventions: (a) meeting with a support worker using the SMART website~     to guide interaction (health intervention), or (b) meeting with a support worker delivering a~     social interaction-based control condition (social intervention). In each condition, there~     will be 8 x 50min face-to-face sessions over 3 months. Assessments will be completed~     pre-randomisation, and at 3, 6 and 9 months.~      The primary hypothesis is that participants randomised to the health intervention will show~     greater improvement in personal recovery than participants randomised to the social~     intervention, and that these improvements will be maintained at follow-up (6 and 9 months~     following intake).~   "
83461|NCT02474511|"~     The purpose of this study was to investigate whether general anesthesia will affect the~     postoperative recurrence and metastasis of malignant tumor.~   "
83462|NCT02474498|"~     To clinically evaluate the treatment of mandibular class II furcation defects with enamel~     matrix derivative (EMD) and/or a bone substitute graft make of beta tricalcium~     phosphate/hydroxyapatite (βTCP/HA).~   "
83463|NCT02474485|"~     AbsorbISR is a randomized, controlled trial, single center, prospective, not blinded to~     evaluate two strategies of in stent restenosis treatment: Implantation of drug eluting~     bioresorbable stent scaffold Absorb® vs. balloon angioplasty with drug eluting balloon~     Sequent Please®.~   "
83464|NCT02474472|"~     The primary objective of the study is to compare the efficacy of standard local anesthetic~     bupivicaine and liposomal bupivicaine in postoperative pain control both in magnitude and~     duration in patients undergoing sternotomy, thoracotomy, thoracoabdominal, and laparotomy~     incisions.~   "
83465|NCT02474459|"~     The purpose of this study is to test the use of a clinical decision support tool for~     postoperative care of Parkinson's disease patients who are treated using deep brain~     stimulation (DBS). The central hypothesis is that the use of a DBS clinical decision support~     system for individual patient management will enable considerable time savings and reduced~     burden on patients and caregivers.~   "
83466|NCT02474446|"~     The investigators want to make sure that people get the right dose of Vitamin D treatment.~     They will therefore investigate how skin colour, body mass index, ethnicity, vitamin D~     binding protein and genetic variation affect the response to a standard course of vitamin D~     in young adults, as a prelude to further studies in younger children.~   "
83467|NCT02474433|"~     This is a randomized trial, assessing Misoprostol efficacy in cervical preparation several~     hours prior to hysteroscopy, comparing the different routes of administration (PO/PV/buccal).~     Initial cervical dilatation will be assessed, as well as surgical ease of dilatation, time~     required to achieve dilatation and patient preference.~   "
83468|NCT02474420|"~     This is a randomized, open label, two arms superiority trial of a representative population~     of patients with a primary diagnosis of transfusion dependent thalassemia with evidence of~     moderate cardiac iron overload, defined as an average T2* MRI parameter at the mid~     inter-ventricular septum between 10 and 20ms.~   "
83469|NCT02474407|"~     This is a multi-center, open-label, crossover, pharmacokinetic, bioavailability study~     involving adolescents and adults with refractory (drug-resistant) epilepsy~   "
83470|NCT02474394|"~     This study is designed to compare the effects of the McGrath Series 5 video laryngoscope and~     Macintosh laryngoscope on intraocular pressure during laryngoscopy.~   "
83471|NCT02474381|"~     The vascular pathologic basis of diabetic foot include arterial obstruction and~     micro-circulation defects.The latest technology of arterial reconstruction can only rebuild~     blood flow of anterior,posterior tibial artery and peroneal artery.Endothelial progenitor~     cells have been proved to integrate into damaged vascular endothelium and improve~     vasculogenesis in vitro and in animal experiment.Therefore endothelial progenitor cells are~     supposed to improve the micro-circulation status of diabetic foot patients.In this trial,the~     investigators recuit diabetic foot patients with infrapopliteal arterial obstructive~     disease,treat them with autologous endothelial progenitor cells after intraluminal~     intervention,and observe the therapeutic efficacy comparing to single intraluminal~     intervention.~   "
83472|NCT02474368|"~     This research study seeks to gain new knowledge about the addition of a carefully targeted~     boost dose of radiation as a possible treatment for recurrent or metastatic head or neck~     cancer. The name of the study intervention involved in this study is stereotactic body~     radiotherapy, which is a way of delivering radiation in a more precisely targeted way and~     with a higher dose than conventional radiotherapy.~   "
83473|NCT02474355|"~     The aim of this study is to assess the efficacy and safety of single agent AZD9291 in a real~     world setting in adult patients with advanced or metastatic, epidermal growth factor receptor~     (EGFR) T790M mutation-positive Non-Small Cell Lung Cancer (NSCLC), who have received prior~     EGFR-tyrosine kinase inhibitor (TKI) therapy.~   "
83474|NCT02474342|"~     The purpose of this study is to evaluate safety and efficacy of Autologous Adipose Tissue~     Derived Mesenchymal Stem Cells injection in patient with Rotator Cuff disease.~   "
83484|NCT02474212|"~     To evaluate the pharmacokinetics of the thromboprophylactic agent enoxaparin in postoperative~     cardiac surgery patients by comparing plasma anti-Xa activity when enoxaparin is administered~     either as a continuous intravenous infusion or subcutaneous bolus once daily.~      After informed consent, 80 elective on pump CABG patients with a clinical indication for~     post-operative thromboprophylaxis will be studied in the Tampere University Hospital Heart~     Central. The study will consist of two independent parts. In the first part of the study~     twenty elective CABG patients will be randomised to receive subcutaneous enoxaparin~     (Klexane®, Sanofi-Aventis) 40 mg thromboprophylaxis every 24 hours for three days. Another~     twenty patients will be randomised to receive the same dose of enoxaparin (40 mg) daily as~     continuous intravenous infusion for three days (72 hours). In the second part of the study~     twenty elective CABG patients will be randomised to receive subcutaneous enoxaparin~     (Klexane®, Sanofi-Aventis) 0,5 mg/ kg twice a day. Another twenty patients will be randomised~     to receive enoxaparin 1 mg/kg daily as continuous intravenous infusion for three days (72~     hours).~   "
83475|NCT02474329|"~     Background: Long-term management of Parkinson's disease (PD) does not reach its full~     potential due to lack of knowledge about disease progression. The Real-PD study aim to~     evaluate the feasibility and compliance of usage of wearable sensors in PD patients in real~     life. Moreover, an explorative analysis concerning activity level, medication intake and mood~     will be done.~      Methods: Overall, 1000 PD patients and 250 physiotherapist will be enrolled in this~     observational study. Dutch PD patients will be recruited across the country and an assessment~     will be performed using a short version of the Parkinson's Progression Markers Initiative~     (PPMI) protocol. Moreover, participants will wear a set of medical devices (Pebble~     Smartwatch, fall detector) and they will use a smartphone with The Fox Insight App (Android~     app), 24/7, during 13 weeks. Primary measures of interest are: 1) physical activity, falls~     and tremor, measured by the axial accelerometers embedded in the Pebble watch and fall~     detector; and 2) medication intake and mood reports measured by patients' self-report in the~     Android app. To measure motor impact, an assessment will be performed by physiotherapists who~     are all Unified Parkinson's disease rating scale - (MDS-UPDRS) certified.~      Discussion: Management of PD patients is complex and appears to be a challenging task for~     health care professionals. The main reason is the lack of knowledge in the disease pattern.~     This issue could be solved by a long term follow-up of patients' during their everyday life,~     and wearable medical devices can act as a way to collect data about every day life~     activities. Therefore, the Real-PD study will be a first contribution in increasing the lack~     of knowledge in disease progression, developing a new medical decision system and improving~     PD patients' care.~   "
83476|NCT02474316|"~     This is a prospective, randomized, multicenter, open-label study. After more than 24 weeks NA~     treatment, HBeAg positive CHB patients who achieved HBV DNA<1000copies/ml but HBeAb negative,~     will be randomized (1:1) into 2 study arms as follows:~      Arm A: Peginterferon alfa-2a 180μg /wk plus NA 1 piece qd for 48 weeks Arm B: Entecavir 0.5mg~     qd for 48 weeks~   "
83477|NCT02474303|"~     Recent breakthroughs in antiretroviral (ARV)-based prevention provide new opportunities to~     rethink HIV prevention and treatment strategies, especially for key populations such as~     Female Sex Workers (FSWs). Antiretroviral (ARV)-based prevention of HIV transmission has the~     potential to have a profound population-level impact on the course of the HIV/AIDS pandemic.~     Several recently completed randomized controlled trials of HIV Pre-exposure Prophylaxis~     (PrEP) have shown efficacy at reducing HIV acquisition in high-risk populations. How to~     translate these trial results into population-level effects is the next critical step. PrEP~     demonstration projects, in collaboration with local stakeholders and at sites of routine~     care for high-risk populations provide an opportunity to move promising research results into~     actual public health benefits. With these key features in mind, the investigators propose an~     HIV PrEP demonstration project in FSW in Dakar, Senegal, West Africa. The objective of the~     proposed demonstration project with Tenofovir DF/Emtricitabine (TDF/FTC) among Female Sex~     Workers (FSW) in Dakar Senegal is to build a sustainable HIV PrEP program for FSW in Dakar,~     Senegal while demonstrating the feasibility of providing daily oral PrEP with Truvada~     (TDF/FTC) for 12 months to the enrolled FSW at Ministry of Heath run clinics (Pikine, Mbao,~     Rufisque and Diamniadio Health Centers). Critical milestones for this demonstration project~     with be feasibility, uptake, acceptability, use of TDF/FTC PrEP and programmatic retention of~     FSWs in Dakar MoH clinics. The investigators have assembled an expert team from RARS,The~     University of Washington, and Westat that have had greater than 2 decades of collaboration on~     HIV related projects in FSWs in Senegal. The investigators expect the results of this project~     will show that Senegal provides a unique opportunity to assess acceptability, feasibility,~     uptake and effectiveness of oral HIV PrEP at reducing HIV transmission in a high-risk FSW~     population.~   "
83478|NCT02474290|"~     The purpose of this study is to evaluate the efficacy of sorafenib for prophylaxis of~     leukemia relapse in allogeneic stem cell transplant (Allo-HSCT) recipients with FLT3-ITD~     positive acute myeloid leukemia (AML).~   "
83479|NCT02474277|"~     The aims are to identify predictive indicators of hospitalized elderly medical patients' need~     for rehabilitation and to validate (known group validity) the Chair Stand Test~   "
83480|NCT02474264|"~     This study evaluates the effect of BRCA1&2 mutations on cardiovascular diseases by to~     comparing the endothelial function of male BRCA mutation carriers with that of age matched~     non-BRCA mutation carriers.~   "
83481|NCT02474251|"~     The 'Amyloid Cascade Hypothesis' posits that the accumulation of a peptide, amyloid beta~     (Aβ), in the brain is the initiating event in Alzheimer's disease (AD), however, the~     mechanisms involved are not well understood. Recent studies support the hypothesis that Aβ~     dynamics in the brain are influenced by the sleep-wake cycle, with increases in the~     production of soluble Aβ during wakefulness and decreases during non-rapid eye movement~     (NREM) sleep, and more specifically on NREM stage 3 (also called slow wave sleep [SWS]).~     These changes produce a consistent diurnal pattern in the cerebrospinal fluid (CSF) that has~     been documented in murine models and in humans. By better understanding this sleep-wake~     relationship the investigators hope to identify how sleep disorders accelerate the~     progression of AD in the elderly (which has been demonstrated by multiple epidemiological~     studies) and, in turn, identify novel therapeutic targets for AD prevention.~      The purpose of this study is to elucidate how soluble amyloid beta (Aβ) levels in the brain~     are influenced by the sleep-wake cycle in humans, and to test the directionality of this~     relationship through sleep disruption experiments. The investigators will test two models.~     The first model will test how, prior to amyloid deposition, brain soluble Aβ levels may be~     relatively increased in the elderly by two mechanisms: a) loss of total sleep time and SWS~     that occur with normal aging; and b) sleep disturbances such as Sleep Disordered Breathing~     (SDB) or insomnia that are common in late life (Aim 1). The second model will test how~     stage-specific sleep disruption may lead to increased CSF Aβ42 levels (Aim 2). A group of~     adults with diagnosed severe SDB and good continuous positive airway pressure (CPAP)~     compliance will be used to test this model sleep deprivation experiments using therapeutic~     CPAP vs. sham CPAP.~      This project will be the first to explore the protective effect of SWS on Aβ42 dynamics in a~     group of cognitively normal elderly subjects as well as the effect of acute sleep disruption~     by CPAP withdrawal on CSF Aβ42 levels in a well characterized clinical sample of severe~     obstructive SDB patients on treatment with CPAP. The results from this study will improve our~     understanding of the nature of the Aβ diurnal pattern and the brain consequences of full~     night sleep disruptions as well as sleep disruptions during specific stages of sleep.~   "
83482|NCT02474238|"~     No single type of laser or set of laser parameters is appropriate for all type of irides.~     Pure Nd:YAG laser iridotomy is very effective in the light color irides. It was considered as~     the gold standard for iridotomy. It, however, is less effective and causes some complication~     such as iris hemorrhage especially in patients with dark iris.~   "
83483|NCT02474225|"~     The introduction of additional fluid into the vitreous cavity by intravitreal therapy would~     be expected to cause an immediate rise in the intraocular pressure. This transient,~     short-term intraocular pressure elevation (lasting up to 30 minutes) after intravitreal~     anti-vascular endothelial growth factor therapy has been well describe. The investigators aim~     to study the prevalence of the sustained intraocular pressure elevation associated with~     intravitreal injection of anti-vascular endothelial growth factor agents.~   "
83485|NCT02474199|"~     This research study is for liver transplant recipients and their respective living donors.~      The purpose of this study is:~        1. To see if it is safe for liver recipients to receive one dose of donor reactive T~          regulatory cells (Tregs)~        2. To see if the Tregs allows a liver recipient to take less, or completely stop~          medications normally taken after receiving an organ transplant.~   "
83487|NCT02474173|"~     This phase Ib trial studies the side effects and best dose onalespib when given together with~     paclitaxel in treating patients with triple negative breast cancer that has spread to other~     places in the body and usually cannot be cured or controlled with treatment (advanced).~     Onalespib works by blocking proper processing of proteins that are important for cancer~     growth. This results in inability of these proteins to work properly. Paclitaxel kills breast~     cancer cells by interfering with their ability to divide. Giving onalespib together with~     paclitaxel may be better in treating patients with breast cancer.~   "
83488|NCT02474160|"~     This research trial collects and stores tissue and blood samples from patients with cancer.~     Collecting and storing samples of tissue and blood from patients with cancer to study in the~     laboratory may help scientists create new and better models to learn about cancer and to test~     new cancer drugs.~   "
83489|NCT02474147|"~     The purpose of this study is to~        1. Compare effects of two isocaloric meals (processed meat hamburger vs. vegetarian~          sandwich) in response to the postprandial period by using functional brain imaging of~          reward circuitry implicated in food motivation and energy balance in patients with type~          2 diabetes (T2D), obese subjects and healthy controls.~        2. Characterize some of the pathophysiological mechanisms of action of different meals in~          obese and T2D subjects vs. in healthy controls (serum concentrations of glucose, FFA,~          IRI, C-peptide, gastrointestinal hormones, oxidative stress markers)~   "
83490|NCT02474134|"~     The purpose of this study is to compare the safety, tolerability, and blood levels of two~     interferon beta-1b products, Betaferon and PF530, in healthy volunteers.~   "
83491|NCT02474121|"~     This study will continue to evaluate the performance of the MarrowStim™ PAD Kit to treat~     subjects with critical limb ischemia (CLI) caused by severe PAD.~   "
83492|NCT02474108|"~     This study evaluates the safety and efficiency of surgical prevention of atrial fibrillation~     in patients with valvular heart disease and left atrium enlargement~   "
83493|NCT02474095|"~     This randomized pilot clinical trial studies alternate schedules for acupuncture-like~     transcutaneous electrical nerve stimulation (ALTENS) in treating dry mouth (xerostomia)~     caused by radiation therapy (RT) in patients with head and neck cancer. ALTENS is a procedure~     in which mild electric currents are applied to certain acupuncture points on the body and may~     help relieve dry mouth caused by RT and improve quality of life. It is not yet known whether~     giving ALTENS more frequently works better than standard ALTENS in treating dry mouth caused~     by RT.~   "
83494|NCT02474082|"~     This is a randomized, controlled, multicenter, open-label study with blinded assessment of~     the efficacy of subcutaneous secukinumab compared to Fumaderm®, in 200 adults with moderate~     to severe plaque type psoriasis who are candidates for systemic therapy. The study consists~     of 2 periods: a screening period of at least one week and up to four weeks, and a treatment~     period of 24 weeks. During the screening period eligibility of the patients is confirmed.~     Eligible patients are randomized 1:1 to treatment arm A or B at week 0. Patients in treatment~     arm A receive secukinumab administered at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20 and are~     followed up for assessments of the study endpoints until week 24. Patients in treatment arm B~     receive daily doses of Fumaderm® p.o.. Safety and efficacy measurements of secukinumab and~     Fumaderm® will be performed throughout the study and up to week 24.~   "
83495|NCT02474069|"~     This study is designed to support the optimal use of secukinumab by providing data to refine~     guidance on dosing flexibility in patients with psoriasis. The purpose of the study is to~     explore the effects of dosage interval shorteng to achieve PASI 90 at week 32 for patients~     who had less than almost clear skin at week 16.~   "
83496|NCT02474056|"~     We hypothesis that in various situation when the effective blood volume decreased the venous~     volume flow characteristics change according to the fluid resuscitation~   "
83497|NCT02474043|"~     The goal of this study is to evaluate the effectiveness of a brief, computerized behavioral~     intervention for promoting screening for hepatitis C and reducing risky behavior for people~     who inject drugs (PWID).~   "
83498|NCT02474030|"~     This study was conducted with an aim to know how individual attributes associated to~     intraoral Pain Tolerance Threshold. The hypotheses were that the Pain Tolerance Threshold~     associated to age, sex, prosthodontic oral condition evaluated by the Eichner Index, and~     psychological state evaluated by the Profile of Mood States.~   "
83499|NCT02474017|"~     To confirm the robustness of the CRC749 inhaler.~   "
83500|NCT02474004|"~     In the past it was shown, that medial partial meniscectomy (MPM) leads to an increase of the~     knee adduction moment (KAM) during walking. Other researches found out that an increase of~     the KAM is an important factor contributing to degeneration joint disease of the knee~     (osteoarthritis). Today, medial menicus repair (MMR) is favoured by many knee surgeons,~     because preserving as much of the meniscus as possible is assumed to delay degenerative joint~     disease.~      The investigators hypothesize significant differences in knee adduction moments between~     patients treated with partial medial meniscectomy vs. patients treated with medial meniscus~     repair (hypothesis 1; major hypothesis). Additionally, it is hypothesized that: the mentioned~     groups differ with respect to other kinetic and kinematic key parameters of gait (hypothesis~     2) and that the knee adduction moment correlates with the clinical outcome as determined by a~     typical knee score (hypothesis 3).~   "
83501|NCT02473991|"~     The aim of this prospective longitudinal study was to investigate the relationship between~     placental thickness during the second and third trimesters and placental and birth weights.~   "
83502|NCT02473978|"~     In this study the investigator would like to examine hemodynamic cerebral blood flow and~     brain function by the use of Invos cerebral oximetry in women undergoing cesarean section~     delivery.~      This study is a purely observational study, it will not have any clinical intervention nor~     will it interfere with standard cesarean delivery protocols in any way.~      The investigator's primary objective is to evaluate how anesthesia influences cerebral blood~     flow perfusion during cesarean section deliveries.~   "
83503|NCT02473965|"~     This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the~     efficacy and safety of Immune Globulin (Human), 10% Caprylate/Chromatography Purified~     (IGIV-C) as a corticosteroid (CS)-sparing agent in subjects with CS-dependent Myasthenia~     Gravis (MG).~   "
83504|NCT02473952|"~     The primary objective is to evaluate whether IGIV-C improves MG symptoms as compared to~     placebo in subjects with MG.~   "
83507|NCT02473913|"~     The goal of the proposed study is to evaluate the efficacy and safety of silymarin (milk~     thistle) in children and adults with trichotillomania. The hypothesis to be tested is that~     silymarin will be more effective and well tolerated in children and adults with~     trichotillomania compared to placebo. The proposed study will provide needed data on the~     treatment of a disabling disorder that currently lacks a clearly effective treatment.~   "
83508|NCT02473900|"~     The purpose of this study is to investigate the bioequivalence after administration of~     HIP1403 and HGP0919 in healthy male volunteers~   "
83509|NCT02473887|"~     The purpose of this study is to give children with gastroenteritis with persistent vomiting~     flavored intravenous ondansetron orally. The investigators test the palatability of the drug~     and check the serum level of ondansetron at 4 hours .~   "
83510|NCT02473874|"~     The purpose of this study is to obtain skin spectroscopic data from two imaging systems.~      Comparison groups:~        -  Skin Spect dermoscope~        -  Spatially modulated quantitative spectrometer~   "
83511|NCT02473861|"~     This study is a randomized control cross over trial of exercise training during or after~     taxane-containing chemotherapy treatment for breast cancer. Forty-three women with stage~     I-III breast cancer will be randomized to immediate or delayed thrice weekly exercise~     training for 8-12 weeks. The immediate exercise group will exercise during taxane~     chemotherapy and the delayed group will start exercise 2 weeks after completion of treatment.~     This design will allow for an assessment of the effects of exercise vs usual care during~     treatment, plus a comparison of the training response during vs. after chemotherapy.~   "
83512|NCT02473848|"~     The substance ingenol mebutate (IM) is registered in Switzerland and many countries worldwide~     for the treatment of actinic keratosis (AK). There is no data on the use of IM in organ~     transplant recipients, a population highly affected by AK and skin cancer at large. The~     investigators want to study the use of IM against AK in this high-risk group of patients and~     assess its safety. The investigators are hoping to prove that IM is safe to use in AK of~     organ transplant recipients, allowing its use in the clinical routine treatement of AK also~     in this subset of patients with AK.~   "
83513|NCT02473835|"~     Overweight and obesity are major problems and their complications such as cardiovascular~     disease and type 2 diabetes mellitus pose great burdens on healthcare systems. There is~     accumulating evidence to support obesity being a chronic inflammatory disorder mediated in~     part by the expansion of adipose (fat) tissue.~      In addition to adipocytes (fat cells), adipose tissue contains a whole range of other cell~     types including some immune (white blood) cells. The relative proportions of immune cell~     subpopulations and interactions between the different cell types within adipose tissue may be~     important in the development of type 2 diabetes.~      Previous research by the investigators has suggested that there may be important differences~     in the activation status of certain immune cells located in adipose tissue with increased~     overweight and the production of leptin - an appetite regulating hormone. Properties of~     adipose tissue and inflammatory cells located within it may therefore be sensitive to changes~     in our nutritional status.~      The purpose of the present study is to investigate changes in T cell activation in adipose~     tissue alongside other immunometabolic properties before and after a short period of dieting~     compared to changes in blood.~      Participants will include males aged between 35-55 years old who meet the criteria for~     inclusion. After taking some preliminary measurements and monitoring of normal daily~     activities, participants will reduce their calorie intake to 50 % of their normal~     intake/requirements for 3 consecutive days and will attend 1 session of Laboratory testing~     before and 1 after this period which will take place in the Physiology Laboratories at the~     University of Bath.~      It is hoped that investigating immunometabolic responses within adipose tissue following an~     acute nutritional challenge will help lead to a better understanding of the development of~     diseases associated with being overweight and ultimately help in the development of more~     effective methods for prevention and treatment.~   "
83514|NCT02473822|"~     This is a non-interventional study to retrospectively validate the technical use TLS (Tape~     Locking Screw) in the anterior cruciate ligament. The investigators goal is to test the~     validity of the technique and its positive influence on the resumption of sporting activities~     in relation to the existing literature.~   "
83515|NCT02473809|"~     The purpose of this study is to test whether liraglutide, a drug approved and widely used in~     the treatment of type 2 diabetes, has an effect on bone mass and bone cell function. Type 2~     diabetes may cause multiple complications, and it is well known that patients with type 2~     diabetes have a higher risk of fractures. If Liraglutide can be demonstrated to have a~     positive effect on bone, this may be one among other factors to consider before the decision~     about specific treatment of type 2 diabetes is made for the individual patient.~   "
83516|NCT02473796|"~     Melghat is poorly developed tribal area in India with very high child mortality &~     malnutrition prevalence (grossly inadequate medical facilities). Important health problems.~     Malnutrition , Pneumonia, Tuberculosis, Anaemia, Malaria, Diarrhoea, Premature and L. B. W.~     babies, Neonatal sepsis, Feeding problem, Birth asphyxia. The investigators developed a Home~     Based Child Care (HBCC) model to reduce neonatal mortality rate (NMR), infant mortality rate~     (IMR), under 5 mortality rate (U5MR) and severe malnutrition(SM) in this region.~      Melghat.~      Need of project :~      Melghat is known for highest U5MR in Maharashtra. Overall aims and importance of the~     research:. The results obtained in this area will be applicable for reducing children~     mortality and malnutrition in other parts of Melghat and all other tribal areas of India.~      Methodology: RCT-Home based child care (HBCC) by trained village health workers .(ARI,~     Diarrhoea, Malaria clinically & Neonatal care) in 19 villages. Strengthening of existing~     government ICDS and health system.~      Melghat.~      Need of project :~      Melghat is known for highest U5MR in Maharashtra. Overall aims and importance of the~     research:. The results obtained in this area will be applicable for reducing children~     mortality and malnutrition in other parts of Melghat and all other tribal areas of India.~      Methodology: RCT- (HBCC) by trained village health workers .(ARI, Diarrhoea, Malaria~     clinically & Neonatal care) in 19 villages.~   "
83517|NCT02473783|"~     Objectives:~        1. To evaluate the relationship between improvement of Hamilton Depression Rating Scale~          (HAMD) score and basal SERT availability (binding potential) for the prognosis of MDD~          subjects being treated with Sertraline HCl~        2. To evaluate the SERT availability by means of I-123-ADAM SPECT imaging study for~          assisting in detecting MDD~        3. To evaluate the relationship between basal HAMD score and basal SERT availability for~          MDD subjects~        4. To evaluate the relationship between basal HAMD somatic subscale score and basal SERT~          availability for MDD subjects~        5. To evaluate the relationship between change of SERT availability and change of HAMD~          score for MDD patients being treated with Sertraline HCl~   "
83541|NCT02473471|"~     The purpose of this study is determine the effect the Microosteoperforation (MOPs) using the~     miniscrew on the rate tooth movement. Moreover, measurement of the level of the pain and~     pain's interference, the level of satisfaction and comfort using this protocol. Finally root~     resorption associate with this technique will be evaluated.~   "
83518|NCT02473770|"~     Background:~      - Disasters like earthquakes, floods, and oil spills can give people health problems. Workers~     who respond to a disaster (like police and firefighters) are directly exposed to contaminants~     during the emergency response. So they could be at the greatest risk for these problems.~     Researchers want to gather data about these workers before and right after they go to a~     disaster. They hope this will help them understand the health effects of disasters.~      Objectives:~      - To answer questions about the health effects of disaster exposures. To create a participant~     registry and collect biological samples and health data.~      Eligibility:~      - People at least 21 years of age who are sent to a disaster area for an emergency response.~      Design:~        -  Participants will have 1 study visit.~        -  Participants will answer questions about:~        -  Contact information~        -  Health, lifestyle, emotions~        -  Medical history~        -  Disaster response activities~        -  Things they are exposed to in the environment~        -  Participants may have blood collected from a vein in the arm.~        -  Participants may give biological samples. These may be urine, saliva, cheek cells, nail~          clippings, or hair.~        -  Participants will have a short physical exam. They may have their hip and waist measured~          over their clothes. The amount of oxygen in their blood may be measured by a sensor on a~          finger or ear.~        -  Participants may have a lung function test. They will take a deep breath and exhale~          strongly.~        -  Participants will be asked to agree to be contacted later to update contact data and~          learn about future studies.~   "
83519|NCT02473757|"~     Background:~      - Gene therapy is a way to treat or prevent disease using genes. It is monitored very closely~     by regulators because there can be long-term, unexpected side effects. NIH is required to try~     to contact people who have been treated with gene therapy at least annually for up to 15~     years. This is to see if they have had any bad side effects. This trial does not include any~     therapy and is only for patients previously treated on gene-therapy trials at the NCI~     Experimental Transplantation an Immunology Branch who are no longer enrolled on their~     original gene therapy clinical trial.~      Objective:~      - To collect of long-term follow-up data on people who have been in gene transfer studies.~     This follow-up is required by regulators.~      Eligibility:~      - People age 18 and older who have been in a previous NCI Experimental Transplantation and~     Immunology Branch gene therapy research study.~      Design:~        -  After they get the genetically modified cells, participants will:~        -  Have blood drawn 3, 6, and 12 months later.~        -  Have an annual clinic visit for the next 4 years. They will have a physical exam. They~          will answer questions about any signs of neurological, autoimmune, or blood disorders,~          or any new cancers. Blood <TAB>may be drawn.~        -  Be called or emailed annually for the next 10 years. They will answer health questions.~          Blood samples may need to be taken.~        -  Participants will be asked for their current address and phone number. They will also be~          asked for the address and phone number of 1 or 2 people who will know their whereabouts.~          One of these should be a family member if possible,~        -  At the time of the participant s death, researchers will request permission from their~          family for an autopsy.~   "
83520|NCT02473744|"~     -  Background : Edema of lower extremities is a concern ranging from 19 % to 60% of~          palliative cancer patients. Lymphedema decreases mobility, induces pain, impacts daily~          activities, esthetic and behavior. Usual treatment is based on diuretics and~          physiotherapy but is often unsuccessful. In case of conventional treatment failure, in~          palliative care, subcutaneous drainage can be discussed with the patients. The technique~          is simple, easy to use but remains off the record. Since 2004, 23 cases were reported~          with various methods. All the cases reported were undertaken with various technical~          approaches and efficacy criteria.~        -  Purpose : Investigator hypothesize that the subcutaneous drainage of edema (SDO) is~          effective in case of refractory lymphedema of the lower limbs in palliative care and~          leads to an improvement in QOL in terms of behavioral and autonomy.~   "
83521|NCT02473731|"~     The purpose of this study is to evaluate the activity and safety of KTN3379 in head and neck~     cancer patients and to explore downstream molecular pathways to identify tumor response and~     resistance mechanisms by evaluating various biomarkers before and after treatment.~   "
83522|NCT02473718|"~     The purpose of the study is to determine if a protocol that assesses patients' daily fluid~     intake and output can decrease the overall amount of fluid patients receive during the first~     five days in the ICU. The study will also determine if decreasing overall fluids can decrease~     adverse events associated with mechanical ventilation, such as ventilator-associated~     pneumonias.~      The protocol will include daily ultrasounds and blood draws to evaluate fluid balance.~     Ultrasound will be used to measure changes in the diameter of the inferior vena cava with~     respiration.~   "
83523|NCT02473705|"~     The purpose of this research study is to study the effect of fish oil and bicarbonate (baking~     soda) on exercise. In this study fish oil, bicarbonate or both will be compared to placebo to~     see if study participants increase exercise capacity.~   "
83524|NCT02473692|"~     The present research will pilot-test a new state-of-the-art Internet-based intervention~     targeting adherence facilitation and optimization of medication use, and will be evaluated to~     assess its utility in facilitating adherence and optimization of medication use for acute~     migraine pharmacotherapy. This is not an interventional study and will instead be an~     observational assessment of the feasibility of an online program (a proof-of-concept study).~     The two principal objectives of this study include: (a) examination of the feasibility and~     user usage patterns of an Internet-based intervention designed to potentially enhance~     adherence to medication use recommendations, and (b) determination of the efficacy of the~     Internet-based intervention in potentially increasing knowledge of abortive medication-use~     guidelines and in improving adherence to those guidelines. To meet the objectives of this~     study, a website has been specifically developed including a series of supplemental~     text-based headache materials and a series of videos based social learning theory and~     modeling principles (as opposed to the stereotypical 'talking-heads' mode of information~     delivery).~   "
83539|NCT02473497|"~     This is an open label expanded access protocol for the treatment of up to approximately 40~     adult or pediatric (defined as age <18 years) patients with tumors harboring either a~     chromosomal translocation or activating mutation involving the ALK or ROS1 gene or an~     activating genetic alteration involving the cMET gene who cannot swallow the crizotinib~     capsule but may be able to derive benefit from treatment with an alternative oral formulation~     of crizotinib.~   "
83525|NCT02473679|"~     Cardiac arrest occurs frequently and the outcome after out-of-hospital resuscitation is often~     fatal. Disturbing is that more than half of the surviving patients suffer from permanent~     impairment of cognitive functions, such attention, memory and executive functioning. With all~     the efforts to achieve a high quality initial resuscitation management the time delay between~     cardiac arrest and the beginning the initial resuscitation maneuver is the main reason for~     the still poor outcome. To shorten this fatal time delay, current efforts of national and~     supranational health authorities aime at the non-medically trained lay person, who should~     carry out basic life support directly on the scene supported by the use of public available~     semi-automatic defibrillators (AED).~   "
83526|NCT02473666|"~     Study the influence of transfusion related Patient Blood Management Program actions on~     transfusion-related outcome measures and cost.~   "
83527|NCT02473653|"~     Immune-based therapies (vaccines) are a new focus of clinical investigation. These therapies~     try to assist a patient's immune system (a system in our bodies that protects us against~     infection) in killing tumors. One form of such therapy is the dendritic cell combined with~     HER-2/neu (a type of protein over-expressed in some cancers) vaccine. Dendritic cells are~     immune cells that can tell your immune system to fight infection. In laboratory testing,~     these cells may also help the immune system attack tumors such as breast, kidney cancer or~     skin cancer. The purpose of this research study is to determine if it is both possible and~     safe to administer this vaccine to patients with any HER2+ cancer.~   "
83528|NCT02473640|"~     A Phase 1b/2a, Multi-Center, Open-Label, 2-Period, Fixed-Sequence Study Evaluating the Effect~     of Esomeprazole on SYN-004 Degradation of Ceftriaxone In Healthy Adult Subjects with a~     Functioning Ileostomy~   "
83529|NCT02473627|"~     This is an open-label, cross-over, fixed-sequence study. All subjects will receive the same~     treatment in two study periods. The study is designed to test whether DS-1971a has any effect~     on the activity of various enzymes involved in the metabolism of medicines, using test~     medications. These will be given without and then with DS-1971a to see if DS-1971a has any~     effect on the blood levels of the test medicines.~   "
83530|NCT02473614|"~     We are trying to determine the therapeutic effect of the music glove and conventional hand~     exercise program to patients with spinal cord injuries. All participants will be randomized~     into two groups: AB and BA. They will all exercise at least 3 times a week for 3 weeks with a~     minimal 3 hours exercise time per week. Participants will receive the other intervention at~     their 3 week post therapy follow up visits. Clinical evaluations will be performed at~     baseline 1 and 2 (3 to 10 days apart), post therapy after first intervention, 3-week post~     therapy follow up, post therapy after second intervention, and 3-week post second~     intervention follow up visits.~   "
83531|NCT02473601|"~     Observed the muscle relaxation of mivacurium in patients with liver cirrhosis.Clear of~     mivacurium in patients with liver cirrhosis without muscle relaxant accumulation and delayed~     recovery phenomenon~   "
83532|NCT02473588|"~     A group of engineers at Michigan State developed a novel waveform analysis technique (Long~     Time Interval Analysis [LTIA]) that attempts to estimate cardiac output non-invasively.~     Retrospective comparison of LTIA to invasive techniques (e.g. thermodilution) suggest~     acceptable agreement. Thus, a prospective trial of LTIA is warranted. This study compares~     LTIA to a validated measure of cardiac output - esophageal Doppler monitoring.~   "
83533|NCT02473575|"~     The purpose of this study is to determine whether caffeine gum improves the performance of~     runners completing free timed mass participation 5 km runs in the United Kingdom (UK)~   "
83534|NCT02473562|"~     The effect of varenicline, an alpha4beta2 nicotinic receptor partial agonist on excessive~     daytime sleepiness in Parkinson's disease will be studied in a randomized, double blind,~     placebo-controlled clinical trial with a within-subject crossover design.~   "
83535|NCT02473549|"~     Many individuals are often left with problems moving their arm and hand, months to even years~     after a stroke. Recent progress in research suggests the application of non-invasive brain~     stimulation, such as transcranial direct current stimulation (TDCS), in conjunction with~     rehabilitation exercises can further improve a person's ability to move after stroke.~     However, the problem is that this doesn't work for everyone, and researchers do not know why.~     One reason may be that TDCS is currently applied using a one-size-fits-all approach.~     Researchers apply the same type of TDCS to everyone, assuming the stroke affects everyone in~     the same way. But, researchers know this is not the case. For example, each person will~     likely have different amounts of damage to brain regions that control movements. A better~     understanding of how the stroke uniquely affects a person's brain will help us to know which~     is the correct type of TDCS to apply for that person. Therefore, the objective of this~     research is to determine whether the amount of damage to brain regions that control movements~     can predict which type of TDCS will be more effective to help a person improve their ability~     to move. Participants will undergo 1 session of magnetic resonance imaging, and three~     sessions of TDCS.~   "
83536|NCT02473536|"~     Stereotactic Ablative Radiation Therapy (SABR): 5 fractions of 8 Gy or 3 fractions of 12Gy~     fro kidney tumor and tumor thrombus~   "
83537|NCT02473523|"~     Researchers at St. Jude Children's Research Hospital want to investigate the feasibility of a~     yoga intervention for adolescents receiving treatment for lymphoma or leukemia. Adolescents~     who participate in the program may experience improved physical and psychosocial measures.~     Improvements in these areas may increase participation in meaningful activity and improve~     quality of life.~      Adolescents diagnosed with cancer may experience more fatigue, anxiety and pain during~     treatment. Yoga is considered a complementary alternative medicine (CAM) that has been~     implemented into some pediatric oncology rehabilitation programs and has been shown to be~     beneficial in both inpatient and outpatient settings. It may decrease anxiety and increase~     quality of life and hamstring flexibility in teens.~      PRIMARY OBJECTIVE:~        -  To determine the feasibility of yoga intervention for adolescents during lymphoma and~          leukemia treatment.~      OTHER PRE-SPECIFIED OBJECTIVE:~        -  To obtain pilot data regarding efficacy of yoga on pain, quality of life, fatigue and~          physical performance.~   "
83538|NCT02473510|"~     This prospective annual release study is designed to evaluate the safety of 3 new influenza~     virus vaccine strains to be included in FluMist Quadrivalent for the 2015-2016 influenza~     season~   "
83583|NCT02472925|"~     This is a 3-arm, multi-center, patient-randomized, field evaluation of the Way to Cure~     behavioral interventions on medication adherence in HCV.~   "
83542|NCT02473458|"~     Stroke is one of the most important causes of mortality and disability both in developed and~     developing countries. The only food and drug administration (FDA) approved therapy for acute~     stroke is recombinant tissue plasminogen activator (rtPA). But narrow therapeutic window has~     limited the usefulness of thrombolytic therapy. Therefore, finding effective neuroprotective~     drugs for the patients for whom thrombolysis is contraindicated or not feasible seemed to be~     mandatory in the world of cerebrovascular medicine.~      Licorice, extracted from root of a plant scientifically known as Glycyrrhiza glabra, is used~     in food industries. Certain medical properties has been contributed to licorice and~     specifically to its active chemical components such as flavonoids and glycyrrhizic acid (GA).~     GA has been revealed to assert its anti-inflammatory effect by suppression of NF-κB, a key~     component of lipopolysaccharide-induced inflammatory response. Neuroprotective~     characteristics of GA has been widely investigated in recent studies.~      In the present study, the investigators verified the efficacy and safety of oral~     administration of two different doses licorice extract in the patients with acute ischemic~     stroke, in a double-blind randomized controlled trial.~   "
83543|NCT02473445|"~     A long-term extension study to assess the safety, tolerability and efficacy of cysteamine~     bitartrate delayed-release capsules (RP103) in children with inherited mitochondrial diseases~     who previously enrolled into study RP103-MITO-001 (NCT02023866).~   "
83544|NCT02473432|"~     This study, part of a larger research project (The Retornus Study), is aimed to evaluate new~     strategies to optimize rehabilitation outcomes in dysphagic stroke patients. Main objective~     is to assess effectiveness of neuromuscular electroestimulation (NMES) in combination with~     respiratory muscle training (RMT) in the treatment of oropharyngeal dysphagia in subacute~     stroke patients.~   "
83545|NCT02473419|"~     The objective of this research is to use functional magnetic resonance imaging (fMRI) with a~     neuropsychological task to test the prefrontal mechanism of action of the medical food~     Vayarin.~   "
83546|NCT02473406|"~     Infected pancreatic necrosis and its related septic complications are the major cause of~     death in patients with acute pancreatitis, therefore prevention of pancreatic infection is of~     great clinical value in the treatment of AP.~      Immunosuppression and disorders characterized by decreased HLA-DR expression and unbalanced~     CD3/CD4+/CD8+ T cells of PBMC are thought to be associated with the development of pancreatic~     infection. Thymosin alpha 1 has been shown to have immunomodulatory properties and its~     effects in preventing pancreatic infection was not well studied. To evaluate the effects of~     TA1 use in the early phase on preventing pancreatic infection, immunomodulation and clinical~     outcomes in patients with AP,we aimed to design this study.~   "
83547|NCT02473393|"~     To assess safety, efficacy and pharmacokinetics of multiple dosesin patients with Bacterial~     Enteritis caused by Clostridium difficile infection(CDI) or Enteric infection.~   "
83548|NCT02473380|"~     Intraoperative surgical fluorescence microscopy is a useful technique for the surgical~     resection of glioma. However the accuracy of this method is limited by its too low~     sensitivity. Fluorescence spectroscopy has the potential capacity to overcome the current~     limitations of conventional fluorescence guided surgery by increasing the sensitivity: in a~     pilot study on brain tumor biopsies, fluorescence spectroscopy was shown to measure~     two-peaked 5-ALA-induced protoporphyrin IX (PpIX) fluorescence emission spectrum which~     clearly enables to distinguish the solid component of glioblastomas from low grade gliomas~     and infiltrative component of glioblastomas. This innovative method could become in future a~     useful tool for real-time diagnosis of brain lesions (initial diagnosis or follow-up post~     resection to check for residual dysplasia) and real-time assessment of resections margins~     during surgery. However, those preliminary ex-vivo results have to be confirmed in a~     feasibility in-vivo study on human.~   "
83549|NCT02473367|"~     In order to define the safe windows for co-dosing of metal-cation antacids with once daily~     administered raltegravir, this study will evaluate the effect of both calcium carbonate and~     magnesium/aluminum hydroxide antacids on the pharmacokinetics of raltegravir, due to dosage~     of 1200 mg raltegravir in HIV-infected participants already taking 400 mg raltegravir twice~     daily as part of their HIV treatment regimen.~   "
83550|NCT02473354|"~     Purpose of the Study: (1) To classify an individual subject's ventilatory response in terms~     of respiratory depression to a bolus of remifentanil under normoxic and hyperoxic conditions.~     (2) Measurement of specific respiratory parameters to predict the opioid-induced respiratory~     depression (OIRD) response.~   "
83551|NCT02473341|"~     Severe Alcoholic hepatitis, defined by modified Maddrey's Discriminant Function (DF) ≥32, is~     associated with significant morbidity and mortality.(1,2) Of the various treatment modalities~     evaluated for treatment of Severe Alcoholic hepatitis, corticosteroids have been the most~     extensively studied.(1) Five out of 13 randomized controlled trials, and four out of 5~     meta-analysis have shown a survival benefit with corticosteroids, especially in patients with~     DF ≥32 and/ or encephalopathy.(1-4) However, the role of corticosteroids in Severe Alcoholic~     hepatitis still remains controversial.(5-6) Corticosteroid therapy is not considered the~     ideal option by most authors because their beneficial effect seems to be confined to a highly~     select minority group in which the inhibitory effect of corticosteroids on liver inflammation~     is not outweighed by side effects such as weakened defence against infections, anti-anabolic~     effects, and possible ulcer promoting effects.(6) Corticosteroids are usually contraindicated~     in those with DF > 54 or MELD >24 (7) .Also corticosteroids are contraindicated in those with~     renal failure, gastro-intestinal bleed, pancreatitis and active sepsis. Therefore, there have~     been constant efforts to evaluate new therapies for Severe Alcoholic hepatitis (SAH). In a~     recent trial, combination of glucocorticoids plus N-acetylcysteine was found to improve one~     month survival in patients with Severe Alcoholic hepatitis, compared with glucocorticoids~     alone. However, the 6 month survival similar in both the groups.(8) Human colostrum and~     bovine colostrum are rich in protein, immunoglobulin, lactoferrin and growth factors. Recent~     studies suggest that colostrum components, immunoglobulin and growth factor benefits~     physically active person as well as in the treatment of autoimmune disorders. It is used for~     the treatment of a wide variety of gastrointestinal conditions, including non-steroidal~     anti-inflammatory drug-induced gut injury, Helicobacter pylori infection, immune deficiency~     related diarrhea as well as infective diarrhea.(9,10,11) It has also been sucessfully used to~     significantly decrease the level of Endotoxemia - lower levels of Lipopolysaccharides.~      We plan to compare the efficacy of bovine colostrum versus Placebo (Pasteurized milk powder)~     alone in treatment of severe alcoholic hepatitis. Bovine Colostrum is rich in protein,~     immunoglobulin, lactoferrin and growth factors. Recent studies suggest that Colostrum~     components, immunoglobulin and growth factor benefits physically active person and in~     treatment of autoimmune disorders. It is used for the treatment of a wide variety of~     gastrointestinal conditions, including non-steroidal anti-inflammatory drug-induced gut~     injury, H pylori infection, immune deficiency related diarrhea as well as infective~     diarrhea.(9) The guidelines by American College of Gastroenterology (10) and other authors~     (11) have suggested that a combination of Corticosteroids and other drugs, which have~     different mechanisms of action, may be more beneficial for reducing mortality in severe~     alcoholic hepatitis. Hence, the investigators plan to compare the efficacy of combined~     therapy of Corticosteroids and Bovine colostrum versus Corticosteroids alone in treatment of~     severe alcoholic hepatitis.~   "
83584|NCT02472912|"~     Double-Blind, 3-Way Parallel Study to Compare the Pharmacokinetics, Safety and Tolerability~     of BMO-2 to EU and US Sourced Humira® Administered as a Single Dose (40 mg) Subcutaneous~     Injection in Healthy Adults.~   "
83585|NCT02472899|"~     The study aims to identify immune biomarkers in peripheral blood for identifying Alzheimer's~     disease (AD). Blood samples from subjects with AD will be compared to age-matched controls~     without cognitive symptoms, as well as healthy younger subjects.~   "
83552|NCT02473328|"~     The goal of antiretroviral therapy should be maintaining undetectable plasma viral load, only~     present condition to prevent the progression of the disease, improve immune restoration and~     prevent the emergence of viral resistance mutations. In addition to the individual benefit,~     antiretroviral treatment reduces the transmission of HIV from an infected person to sexual~     partners. There is to date no alternative strategy to antiretroviral treatment and~     antiretroviral therapy, even extended, does not allow viral eradication.~      The need to maintain antiretroviral therapy for life raises the long-term safety concerns of~     it, even with the latest molecules. Also, one of the key issues in clinical research is~     whether after reaching undetectable viral load, antiretroviral treatment can be reduced in~     order to reduce exposure to molecules. Indeed, this treatment of maintenance could~     potentially need a smaller antiviral potency. On the other hand, reduction of antiretroviral~     treatment reduces costs, an important consideration in light of new global recommendations of~     treatment for all patients with T-cells CD4 below 500 / mm3.~      The alleviation of antiretroviral therapy is to either reduce the number of molecules by~     making monotherapies or dual therapy, or to realize or intermittent treatment is to reduce~     the doses of molecules such as randomized ENCORE -1 showing the equivalence of a dose of~     Efavirenz 400mg instead of 600mg in naive patients.~      Atalow study has the sense to lower the dose of Atazanavir / Ritonavir in combination with~     two NRTI to reduce exposure to this molecule and its cost while maintaining an undetectable~     viral load.~   "
83553|NCT02473315|"~     Whole body cryotherpy (WBC) is a well-tolerated procedure that implies patients' exposition~     at a temperature of approximately -110 degrees.~      A considerable increase in the popularity of WBC has occurred in rheumatologic patients,~     despite a lack of evidences of its efficiency.~      Because of its interesting anti-inflammatory properties, the investigators think that WBC~     could be an alternative treatment to classical NSAIDs (Non Steroidal Anti Inflammatory Drugs)~     and corticosteroids, in patients suffering from axial spondyloarthritis.~      This is a proof of concept study.~   "
83554|NCT02473302|"~     Colorectal Cancer is, in non-smokers for both sex, first cause of cancers mortality in~     Western country.~      The main risk factors associated with colorectal cancer depend of lifestyle, and processed~     meat and red meat could be involved in carcinogenesis by cytotoxic and genotoxic compound~     linked to lipid peroxidation and nitrosation.~      The aim of this study is to study the impact of the daily consumption of beef, processed or~     not, on lipid peroxidation induced heme iron ; and to study the impact of the daily~     consumption of ham, processed or not, on the nitrosilation induced heme iron.~   "
83555|NCT02473289|"~     The purpose of this study is to evaluate the efficacy of sirukumab as adjunctive treatment to~     antidepressant therapy (monoaminergic antidepressant) where sirukumab (administered as a 50~     milligram (mg) subcutaneous (SC) injection at Day 1, Day 28 and Day 56 during the 12- week~     double-blind treatment period) is compared to adjunctive placebo based on the change from~     baseline to 12-week endpoint in depressive symptoms as measured by the total score on the~     Hamilton Depression Rating Scale (HDRS), in participants diagnosed with Major Depressive~     Disorder (MDD) who have had a suboptimal response to the current standard oral antidepressant~     therapy and have a screening high sensitivity C-Reactive Protein (hsCRP) >=0.300 milligram~     per deciliters (mg/dL) (International System of Units (SI) 3.00 mg/L). A cohort of subjects~     with hsCRP <0.300 milligram per deciliter will also be enrolled to allow a better~     understanding of the relationship between CRP and clinical changes.~   "
83556|NCT02473276|"~     Neuraxial analgesia (most commonly continuous epidural or combined spinal epidural) is the~     most effective modality available for pain relief during labor. Accidental dural puncture~     (ADP) with a large bore epidural needle and the resulting post-dural puncture headache (PDPH)~     is one of the most significant sources of anesthesia-related morbidity in parturients.~      Epidural blood patch (EBP) is the gold standard for treatment of PDPH, and although almost~     always effective, can result in another ADP, as well as low back pain and lower extremity~     pain. For this reason, effective measures to prevent PDPH when ADP occurs would be highly~     valuable. One small study in which 50 women were randomly allocated to receive 2 epidural~     injections of morphine or saline, demonstrated a beneficial effect of epidural morphine in~     decreasing the incidence of PDPH.~      This study aims to determine the efficacy of 2 doses of neuraxial (either epidural (EPID) or~     intrathecal) preservative-free morphine (PFM) to prevent headache after ADP in parturients.~   "
83557|NCT02473263|"~     The purpose of this study is to determine whether an aggressive strategy of severe sepsis~     patients since pre hospital care, including early antibiotics administration, hemodynamic~     optimization, and opotherapy when indicated, could reduce mortality~   "
83558|NCT02473250|"~     This study is for subjects with a diagnosis of bipolar disorder who have depression at the~     time of recruitment. It involves brain imaging with an MRI (magnetic resonance imaging) and~     PET scan (positron emission tomography) and treatment with an antidepressant. The medication~     involves adding an SSRI (either celexa/citalopram or prozac/fluoxetine) to a mood stabilizer.~   "
83559|NCT02473237|"~     Chronic Obstructive Pulmonary Disease (COPD) secondary to biomass exposure constitutes a~     chronic respiratory condition frequently excluded from large clinical trials. Biomass~     exposure COPD have some histopathologic, clinical, radiological and functional differences~     with tobacco smoke COPD. However, until now, there are no evidence in this patients about the~     clinical response to bronchodilators routinely used in tobacco smoke COPD.~      Primary objective: To compare changes in walked meters from baseline on six minute walking~     test (6MWT) to 23:45 hours after one dose of indacaterol vs tiotropium in patients with~     moderate to severe COPD secondary to biomass exposure.~      Secondary objectives: To compare changes in pulmonary function (inspiratory capacity, Forced~     Expiratory Volume in first second (FEV1) milliliters, FEV1 through) from baseline (-10~     minutes) to 23:45 hours after one dose of indacaterol vs tiotropium in patients with moderate~     to severe COPD secondary to biomass exposure.~      This will be an open label study, double blinded, cross over and conducted at specialized~     respiratory care center (National Institute of Respiratory Diseases), to compare the acute~     effects of ultra long acting bronchodilators used in tobacco smoke exposure COPD. Unicentric~     study.~      Ethics Committee approbation: C 22-12~   "
83586|NCT02472886|"~     The primary objectives of this study are to evaluate the antiviral efficacy, safety, and~     tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) with or without~     ribavirin (RBV) in adults with chronic hepatitis C virus (HCV) infection.~   "
83560|NCT02473224|"~     This is a phase I, randomized, double blind, as well as partially blinded (for Cohort 4),~     placebo-controlled safety, illness, and infection study of a new experimental human challenge~     stock of the Norovirus genogroup II, genotype 2 (GII.2) isolate designated Snow Mountain~     virus (SMV). The study duration is 24 - 36 months. The primary objectives are to: 1) evaluate~     the safety and reactogenicity of the GII.2 Snow Mountain norovirus challenge stock and 2)~     determine a safe and optimal challenge dose of GII.2 Snow Mountain norovirus to achieve~     illness in a high proportion (= / > 75%) of subjects.~   "
83561|NCT02473211|"~     For those chronic hepatitis C patients, who are interferon-ineligible or intolerant, there is~     a burning need for the development of pan-oral interferon-free regimen. The investigators~     examine the efficacy and safety of sofosbuvir, a NS5B nucleotide polymerase inhibitor and~     daclatasvir, an NS5A replication complex inhibitor in Chinese treatment-experienced cirrhosis~     patients with chronic G1b infection.~   "
83562|NCT02473198|"~     The main objective of the study is to determine if intrarticular injection with liposomal~     bupivicaine (Exparel) provides better postoperative pain relief and functional outcome~     following total knee replacement (TKR) than the current standard New England Baptist Hospital~     regimen of femoral nerve block combined with intraarticular injection of a standard~     bupivicaine solution.~   "
83563|NCT02473185|"~     Aim: The purpose of the study is to examine the effects of medication, placebo and~     expectation on objective and self-rated performance of ADHD core signs during the Quantified~     Behavior Test in patients with untreated ADHD.~      Subjects: Participants are 40 consecutive patients remitted to a neuropsychiatric~     investigation at the Dependence Clinic Västmanland, Västerås, Sweden.~      Method: The study is a double-blind, randomized, placebo-controlled, cross-over study. The~     study is taken place during four hours on two investigating days, separated by a 4 days~     wash-out period.~      All patients participate on two occasions: In one session they receive the Methylphenidate~     (MPH) condition, and in the other session they receive the placebo condition. MPH and placebo~     conditions are counterbalanced across subjects such that half of the participants receive MPH~     first, and the other half of the participants receive placebo first. Neither the participant~     nor the research assistant is aware when the participant receive the MPH condition or the~     placebo condition.~      On each investigating day the participant accomplish Questionnaires (Visual Analogical~     Scales) concerning; (a) expectation, (b) self-rated performance, (c) exhausting exercise, (d)~     perceived help from the pill and (e) self-rated symptoms. In addition the participant~     completed A Quick Test of Cognitive Speed (AQT) and two separate Quantified Behavior Test~     Plus (QbTest) without medication vs MPH/Placebo. QbTest aims to provide objective information~     regarding core-symptoms of ADHD; hyperactivity on the basis of motor-activity measured with~     the camera, and inattention and impulsivity on basis of the CPT-test.~      The Quantized Behavior Test (QbTest) can be included as part of an neuropsychiatric~     investigation. QbTest measures the three core signs of ADHD, hyperactivity, inattention and~     impulsivity. QbTest is a computer-based test that combines a test of attention ability with a~     movement analysis based on an infrared measurement system. The test results are presented in~     a report and compared with norm data fromm a group of the same sex amd age who do not have~     ADHD.~   "
83564|NCT02473172|"~     This study evaluates the impact of the assisted mode of mechanical ventilation on diaphragm~     efficiency in mechanically ventilated critically ill patients. Participants will be~     randomized to the neurally adjusted ventilatory assist (NAVA) mode or to the pressure support~     ventilation (PSV) mode.~   "
83565|NCT02473159|"~     Near-infrared (NIR) fluorescence imaging using indocyanine green (ICG) has been used for~     breast cancer surgery such as sentinel lymph node (SLN) mapping and breast cancer~     localization.~      In this study, our hypothesis are as following:~        1. As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure~          better outcome.~        2. indocyanine green (ICG) permitted accurate preoperative and intraoperative detection of~          the SLNs as well as nonpalpable benign brest lesion in patients with breast cancer.~   "
83566|NCT02473146|"~     Purpose : The main objective of this study is to assess the efficacy and tolerance of the~     addition of repeated doses of low doses (3mg/m2) of Gemtuzumab Ozogamicin (GO) in addition~     with standard doses of Ara-C in previously untreated patients aged 60 to 80 years with de~     novo acute myeloblastic leukemia (AML) and non adverse cytogenetics. The main end point for~     efficacy is 2 years-event free survival. The secondary efficacy endpoints are CR/Cri rates,~     cumulative incidence of relapse and overall survival. The secondary endpoints for safety are~     early death rate (before day 30 and 60), grade 3 to 5 adverse events and severe adverse~     events, cardiac toxicity and quality of life. Additional secondary endpoints are treatment by~     covariate interactions with respect to biological characteristics present at diagnosis (CD33~     positivity, cytogenetic, molecular abnormalities) or after treatment (Minimal residual~     disease levels). This study is an exploratory study. Patients will be allocated at inclusion~     with a 2/1 ratio either to receive treatment with GO and cytarabine or Idarubicin and~     cytarabine in a 3+7 regimen similar to the backbone ALFA 1200 scheme used concurrently by~     the ALFA group as treatment of AML patients aged >60 years.~      Primary objective. The primary objective is to assess the efficacy of two doses of Gemtuzumab~     ozogamicin (GO) during induction and one dose of GO during first consolidation in combination~     with Cytarabine in elderly patients with AML in the non adverse cytogenetics-risk group.~   "
83567|NCT02473133|"~     In patients with locally advanced stage III non-small cell lung cancer, the probability of~     local control remains low (about 17% at 1 year). Concomitant radio-chemotherapy is the~     standard treatment. An increase in total radiotherapy dose (from 66 to 74 Gray) has been~     proposed to improve local control, with contradictory results.~      Relevant FDG-PET scan images can be acquired during radio-chemotherapy, with a demonstrated~     prognostic impact and recently in a multicentre prospective study. A significant reduction in~     FDG uptake / volume (metabolic response) suggests that the radiotherapy target volume could~     be reduced during radiotherapy possibly improving organs at risk tolerance. Conversely, a~     lack of metabolic response may justify treatment intensification before the end of~     radiotherapy. The investigators hypothesis is to investigate the individual tumour~     heterogeneity on FDG-PET during radio-chemotherapy to reduce the volume to a biological~     target that could receive a higher total dose (personalized dose redistribution).~   "
83568|NCT02473120|"~     The purpose of the study is to determine the frequency ESR1 mutations by Digital PCR in~     patient with metastatic breast cancer.~   "
83587|NCT02472873|"~     The purpose of this study is to evaluate the efficacy of aspiration and sclerotherapy during~     laparoscopy using 95% ethanol for the treatment of endometriomas, compared to the standard~     cystectomy treatment - a prospective case control study.~   "
83588|NCT02472860|"~     The investigators will conduct a randomized placebo-controlled trial of a computerized~     intervention targeting cognition in 30 teens with autism spectrum disorder.~   "
83803|NCT02470065|"~     This is a multicenter, randomized, 1:1, non-comparative phase II trial. Patients with early~     stage NSCLC will be randomized between ARM A: neoadjuvant afatinib followed by surgery and~     ARM B: immediate surgery with curative intent.~   "
83569|NCT02473107|"~     The present study aims to evaluate the impact of detecting active initial caries lesions in~     primary teeth regarding effectiveness, cost-effectiveness, applicability (acceptability and~     satisfaction) and quality of life. For this, 248 children 3-6 years with complete primary~     dentition will be examined and treated in a mobile dental unit, which will temporarily be~     parked in public schools of Sao Paulo. The caries detection will be conducted using the~     International Caries Detection and Assessment System (ICDAS) and, depending on allocation, an~     adjunct criterion for caries activity assessment. Children will be randomized in two groups~     according to the caries threshold to be detected: Group A (only advanced lesions will be~     detected and treated, independently of their activity status) and Group B (all caries~     lesions, including initial ones, will be detected and all active lesions will be treated).~     After this, the treatment plan for each child will be made according to strategies mentioned~     above. Data concerning the cost-effectiveness of the procedures, acceptability / satisfaction~     of children and quality of life will be collected after diagnosis, after the end of treatment~     and 12 and 24 months from the initial examination. For comparison between groups, multilevel~     regression analyses will be performed. The primary outcome will be sites which need of~     operative treatment during the follow-up periods and the secondary outcomes will be the~     cost-effectiveness of each strategy, the acceptability / satisfaction of the child and the~     impact on quality of life.~   "
83570|NCT02473094|"~     A phase II, randomized study of placebo versus metformin in association to chemotherapy with~     capecitabine and radiation in the neoadjuvant treatment of locally advanced (T3-4N0M0 or~     TxN1-2M0) rectal carcinomas.~   "
83571|NCT02473081|"~     The purpose of this study is to determine whether the telephone-delivered Minimal~     Psychological Intervention (MPI) could improve diabetes' depressive symptom and~     diabetes-related immediately , as well as HbA1c level in the long-term.~   "
83572|NCT02473068|"~     Patients who are suffering from a variety of respiratory conditions benefit from continuous~     positive airway pressure (CPAP) which is a form of Non-Invasive Ventilation (NIV). Some~     patients find the temperature of the breathing gas difficult to tolerate. The aim of this~     study is to compare comfort of healthy volunteer participants while being given CPAP at~     different temperatures.~   "
83573|NCT02473055|"~     90 preterm infants were randomly assigned to kangaroo care (skin-to-=skin, chest-to-chest)~     group (n=50) or control (remained in incubator, prone (n=40) for a pretest period of 2- 3~     hours, then fed, then KC group was placed in KC and control group remained in incubator for a~     2-3 hr test period. EEG measures of sleep, HR, and RR were taken. .~   "
83574|NCT02473042|"~     The goal of this clinical research study is to learn if light electrical stimulation to the~     wrist area during surgery is feasible in women having breast surgery.~   "
83575|NCT02473029|"~     The study aims at measuring the sensitivity and specificity of a series of imaging signs~     (recorded by magnetic resonance angiography, vascular tomodensitometry, vascular~     ultrasonography, retina angiography and retina optic coherence tomography) for the diagnosis~     of Horton disease, the gold standard being the result of temporal artery biopsy.~   "
83576|NCT02473016|"~     A placebo-controlled, single-blind study to evaluate the safety and preliminary efficacy of~     nasal carbon dioxide for the symptomatic treatment of classical trigeminal neuralgia.~   "
83577|NCT02473003|"~     Excessive tiredness (fatigue) is a common problem in cancer patients and can affect quality~     of life negatively. There is limited knowledge about the physical mechanisms that cause~     fatigue, and there is no medical treatment. Physical activity can reduce the inconvenience,~     but the investigators need to learn more about the type and intensity of exercise that works~     the best as well as how to motivate patients to exercise. The overall aim, is to evaluate the~     efficacy and cost-effectiveness of individually tailored high (H) and low/medium (LM)~     intensity physical training, with or without behavioural medicine (BM) support strategies,~     during adjuvant oncological treatment on; Cancer Related Fatigue (CRF),Quality of Life (QoL),~     mood disturbance, adherence to the cancer treatment, adverse effects, disease outcome, return~     to a daily life after completed treatment and return to work. The investigators will also~     describe changes in inflammatory markers and cytokines related to physical training and gene~     expressions following training to investigate whether these serve as mediators for the~     effects of physical training on CRF and QoL. This will be evaluated in newly diagnosed~     breast, colorectal and prostate cancer patients during adjuvant therapy at three different~     centres in Sweden; Uppsala, Lund/Malmö and Linköping. A 2x2 factorial design will be used,~     600 patients will be randomised to H, H+BM, LM or LM+BM. Patients will train two times per~     week during 6 months. This project will give; new knowledge about aspects for individuals to~     gain improved well-being and quality of life, facilitated return to work, and possibly~     reduced risk of cancer recurrence. This in turn would result in lower burden on the health~     care system, reduced societal costs and have a positive impact on public health.~     Implementation of the results into clinical practice will be facilitated by the close~     collaboration between researchers and clinicians, and the fact that the study is performed in~     clinical settings.~   "
83578|NCT02472990|"~     The loss of ability to walk in many children with DMD (Duchenne muscular Dystrophy) is a~     pejorative event. Biomechanical and morphological unknowledge about the loss of the walk~     ability in children with DMD is an obstacle in reeducative, pharmacological or surgical~     therapeutic targets.~   "
83579|NCT02472977|"~     The purpose of this study is to determine whether the combination of Ulocuplumab and~     Nivolumab is safe and effective in the treatment of pancreatic cancer and small cell lung~     cancer.~   "
83580|NCT02472964|"~     A multicenter, double-blind, randomized, parallel-group, Phase III study of the efficacy and~     safety of Hercules( Myl 1401O, Mylan Trastuzumab) plus taxane versus Herceptin® plus taxane~     as first line therapy in patients with HER2-positive metastatic breast cancer.~   "
83581|NCT02472951|"~     Scientific evidence for the dietary treatment of type 2 diabetes is insufficient. The~     investigators hypothesize that a lower carbohydrate content in the diabetic diet than the~     recommended 55 E% will decrease the postprandial glucose excursion, decrease insulinotropic~     factors like incretin hormones and decrease their insulinotropic effects due to their glucose~     dependency. This will reduce postprandial insulin concentration, resulting in an improved~     insulin sensitivity and glucose metabolism. This clinical study will examine in diabetic,~     prediabetic and healthy subjects the acute effects of short term highly controlled dietary~     low carbohydrate intervention on metabolic pathways with respect to insulin action,~     pancreatic islet function, lipid metabolism, incretin hormones, low grade inflammation in~     plasma and novel measures of fatty acid metabolism.~   "
83582|NCT02472938|"~     The primary objective of the study is to assess the early efficacy of treatment with BG00012~     (dimethyl fumarate) 240 mg twice daily (BID) in the brain of newly diagnosed and~     naive-to-treatment patients with relapsing-remitting multiple sclerosis (RRMS). The Secondary~     objectives are to establish the time course of the beneficial effect of BG00012 240 mg BID~     over 24 weeks and to evaluate the safety of BG00012.~   "
83589|NCT02472847|"~     The goal of the current proposal is to investigate the effects of a cannabinoid drug on the~     memory of extinguished fear in humans and the brain circuitry important for the recall of~     extinction learning. The investigators findings will translate previous discoveries from~     animal studies to humans and increase their understanding of the neurobiological mechanisms~     supporting retention of extinction memory. This proof-of-concept study is a critical~     translational first step towards the development of cannabinoid modulators as an adjunctive~     strategy to exposure-based therapies to augment extinction learning and prevent the return of~     fear memories in patients with post-traumatic stress and other anxiety disorders.~   "
83590|NCT02472834|"~     Patients with end stage renal disease (ESRD) usually have high levels of urea that may~     interact with blood proteins and change their structure by a process known as carbamylation.~     Evidence suggests that high levels of carbamylated proteins may be linked to adverse outcomes~     in dialysis patients. This is a randomized, open-label study to evaluate the effects of amino~     acid supplementation on levels of carbamylated proteins in ESRD patients. Secondary~     objectives will be to determine whether this intervention can modify intermediate markers of~     inflammation, cardiac stress, and erythropoietin responsiveness in this population. Sixty~     ESRD patients on dialysis will be randomized into two groups of 30 patients each. Group 1~     will receive intravenous supplementation with an FDA-approved amino acid solution (250 mL of~     NephrAmine®, 5.4% amino acids) during regular dialysis sessions (3 times weekly for 8 weeks);~     Group 2 will be treated according to standard-of-care (no amino acid supplementation). During~     the 8 weeks of therapy and for 4 weeks of follow-up, blood will be drawn from patients'~     existing hemodialysis access ports (~20 mL once per month) to measure levels of carbamylated~     albumin, amino acids, selected biomarkers, and standard laboratory values. Patients~     randomized to Group 1 will have fluid volume equivalent to the amino acid therapy removed by~     ultra-filtration to avoid net fluid gain. All patients will be monitored for safety (adverse~     events) and for changes in hemodynamics and dialysis prescription.~   "
83591|NCT02472821|"~     Farm and rural youth have frequent exposure to hazardous noise on the farm and~     recreationally, and have an increased prevalence of noise-induced hearing loss (NIHL). There~     is a lack of programs to prepare this high-risk population to use hearing conservation~     strategies. This randomly-controlled trial of innovative community-based interventions is~     designed to compare effectiveness and sustainability of approaches to increase youths' use of~     hearing conservation strategies. Consistent use of hearing conservation strategies is~     expected to reduce rates of NIHL and other negative effects of high noise exposure, and~     improve quality of life in this high-risk and underserved group.~   "
83592|NCT02472808|"~     This trial compares the yield of cTBNA (conventional Transbronchial Needle Aspiration) versus~     the EBUS-TBNA (Endobronchial Ultrasound guided TBNA) for obtaining cytology when they are~     combined with endobronchial biopsy and transbronchial lung biopsy and rapid onsite~     examination (ROSE) of the obtained smears in the diagnosis of suspected sarcoidosis patients~     visiting our hospital for evaluation of mediastinal lymphadenopathy.~   "
83593|NCT02472795|"~     International trial to evaluate the biological activity and safety of ACT-334441 in lupus~     patients.~   "
83594|NCT02472782|"~     This is a study aiming to investigate a possible correlation between the parameters affecting~     the physicians' therapeutic choice with the patients' overall adherence to osteoporosis~     treatment. Secondary end-points include correlation between the parameters affecting the~     physicians' therapeutic choice and the patients' quality of life as well as the evaluation of~     the whole osteoporosis treatment approach of orthopedic surgeons in Greece (diagnostic means,~     use of diagnostic and treatment guidelines, methodology of follow - up).~   "
83595|NCT02472769|"~     Two different dose levels will be evaluated in two different birth weight categories,~     compared to placebo with regards to safety and tolerability.~   "
83596|NCT02472756|"~     This is a Phase 4, open, prospective, non-interventional, multicenter trial for previously~     treated adult participants with relapsed/refractory follicular lymphoma (FL). Eligible~     participants with FL will receive 6-8 infusions of induction standard regimen of rituximab~     plus chemotherapy. Participants with complete or partial remission at end of induction will~     be assigned to maintenance therapy with rituximab once every 3 months for a maximum of 2~     years or until relapse. The choice of the treatment regimen will be established on a per~     center basis, according to the standard in use in the country and in the center, and each~     center will use the same regimen through the study. Participants will be followed up for~     safety and efficacy evaluation in accordance with routine practice.~   "
83597|NCT02472743|"~     Digital (finger) ulcers are common in patients with systemic sclerosis (SSc) and causes much~     pain and affects how patients use their hands. Our current treatments for digital ulcers are~     often not effective and have may have significant side effects (because they increase blood~     flow to the ulcer to try and help healing).~      Light-based treatment has been successfully used to treat chronic diabetic, pressure and~     venous ulcers. The investigators wish to investigate whether light-based treatment is a safe~     and effective treatment for digital ulcers in patients with SSc.~   "
83598|NCT02472730|"~     The purpose of this study is to identify if performing diagnostic colonoscopy with a small~     plastic cap attached to the camera will improve performance of colonoscopies by physician~     trainees.~   "
83599|NCT02472717|"~     Exploratory, double-blind randomized, placebo-controlled, Phase II study to evaluate the~     effect(s) of short-term administration of liraglutide, a GLP-1R (glucagon-like peptide-1~     receptor) agonist on joint and skin inflammation in patients with active Psoriatic Arthritis.~   "
83611|NCT02472561|"~     The purpose of this study is to understand the effects that a three month lifestyle-based~     mobile health (mHealth) peripheral artery disease (PAD) prevention program will have on~     improving physical activity, fitness, important PAD risk factors and quality of life (QOL) in~     patients with PAD.~      By testing a novel mHealth intervention focused on lifestyle modification, this trial will~     address a critical evidence gap in the care of PAD patients. PAD patients are not eligible~     for cardiac rehabilitation and therefore struggle with unhealthy lifestyles, and these~     patients currently have no lifestyle-based care strategies to help them. The results of this~     study have the potential to lead to new sustainable and resource-efficient, lifestyle-based~     preventive care strategies for patients with stable PAD.~   "
83600|NCT02472704|"~     Patients with lymphocytic enteritis (LE), HLA-DQ2/8+, negative celiac serology and clinical~     and histological response to a gluten-free diet (GFD) do not fulfil the diagnostic criteria~     of coeliac disease (CoD). At present it remains unclear whether they suffer from coeliac~     gluten sensitivity (CGS) or non-coeliac gluten sensitivity (NCGS). There are specific tissue~     markers of CoD such as anti-transglutaminase deposits (tTG) and intraepithelial lymphocytes~     expressing T-cell receptor (TCR) gamma/delta+.~      Aim: To demonstrate the existence of CGS in these patients despite having negative celiac~     serology.~      Methods: Double-blind randomized clinical trial of gluten vs placebo rechallenge for 6 months~     in patients with LE on a GFD. Inclusion criteria: >18 years, initial presentation with GI~     symptoms, HLA-DQ2/8+, negative celiac serology, good clinical and histological response to~     GFD. Patients were randomised to gluten (20 g/day) and placebo (maltrodextrin) (identical~     powder sachets mixed with meals). Clinical symptoms were analysed using visual analogue~     scales. Quality of life (GIQLI), adherence to diet, serology, and histological changes~     including gamma/delta+ IEL and tTG deposits were evaluated.~   "
83601|NCT02472691|"~     This is a prospective, open-label, single-arm multi-center phase II study aiming to evaluate~     the safety and feasibility of the addition of Lenalidomide (investigational drug) to the~     standard therapy of Azacitidine and DLI (standard of care) as first salvage therapy for~     relapse of MDS, CMML and AML with MDS-related changes (sAML, with 20%-30% bone marrow blasts,~     formerly RAEB-T) after allo-SCT. The starting dose of Lenalidomid is 2.5 mg per day for 21~     days with a 7 day rest. The study incorporates 2 interim safety analyses after 10 and 20~     patients in order to find the optimal and safe dose of Lenalidomide.~   "
83602|NCT02472678|"~     Patients with a neuroendocrine tumor (NET) frequently suffer from physical as well as~     psychosocial complaints. Patients may experience various symptoms from tumor burden and~     secreted hormones by the tumor. They also can have complaints due to their anti-cancer~     treatment and accompanying side effects.~      Adequate information is an essential aspect of supportive care. Patients need for information~     and care remain frequently unnoticed. The aim of the current study is to test the~     effectiveness of a web-based tailored information and support system to support patients'~     information and care needs. Key features of this website are patient self-screening of~     physical and psychosocial problems, tailored patient education on reported problems and~     self-referral to professional health care. The investigators expect that the website is a~     highly suitable medium to provide tailored information and support.~   "
83603|NCT02472665|"~     Multicenter, prospective, non-controlled study in a pediatric cohort (<6 years-old) with~     severe Von Willebrand Disease (VWD).~   "
83604|NCT02472652|"~     Sexual dysfunction is highly prevalent in schizophrenic patients, affecting up to 80% of men~     and women. Antipsychotic induced sexual side effects may be a barrier to treatment~     compliance. Antipsychotics such as Risperdal Consta and Invega Sustenna are known to have~     higher rates of causing prolactin elevations that may be implicated in sexual dysfunction.~     The basic premise of this study is to identify patients who believe they have experienced~     sexual dysfunction on Risperdal Consta or Invega Sustenna and switch to the alternative long~     acting injectable antipsychotic, Abilify Maintena which tends to lower prolactin levels.~     Measures of sexual sexual functioning using the self rated 5 item Arizona Sexual Experience~     Scale (ASEX) as the primary outcome measure will be made over a 3 month period to determine~     if such a switch is helpful.~   "
83605|NCT02472639|"~     The purpose of this study is to evaluate patient satisfaction and quality of life in patients~     with ileostomy managed with or without the novel Ostom-i Alert device.~   "
83606|NCT02472626|"~     This phase I/II trial studies the side effects and the best dose of~     6,8-bis(benzylthio)octanoic acid (CPI-613) when given together with cytarabine and~     daunorubicin hydrochloride and to see how well it works in treating older patients with newly~     diagnosed acute myeloid leukemia. CPI-613 may kill tumor cells by turning off mitochondria~     (small structures in the cancer cells that are found in the cytoplasm [fluid that surrounds~     the cell nucleus]). Mitochondria are used by cancer cells to produce energy and are the~     building blocks needed to make more tumor cells. By shutting off mitochondria, CPI-613 may~     deprive the cancer cells of energy and other supplies that they need to survive and grow.~     Drugs used in chemotherapy, such as cytarabine and daunorubicin hydrochloride, work in~     different ways to stop the growth of cancer cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Giving CPI-613 together with~     cytarabine and daunorubicin hydrochloride may kill more cancer cells.~   "
83607|NCT02472613|"~     This is a multicentre, single Blind ,randomized controlled clinical trial in ischemic~     post-stroke depression patients.The participants will be allocated randomly in either of the~     two groups: verum acupuncture plus placebo medication group or sham acupuncture plus true~     medication group. On the hypothesis that acupuncture intervention could produce the same~     therapeutic effects as antidepressants. The investigators also hypothesized that acupuncture~     would be associated with minimal side effects.~   "
83608|NCT02472600|"~     This investigator initiated,international, multicenter open-label, randomized controlled~     trial aims to assess whether a 5 day course of oral nonabsorbable antibiotics (colistin~     sulfate 2 million IU per os 4x/day and neomycin sulfate 500 mg (salt) per os 4x/day )~     followed by fecal microbiota transplantation (administered either via nasogastric~     administration or via capsules) is effective at eradicating intestinal carriage of~     beta-lactamase producing Enterobacteriaceae (ESBL-E) and carbapenemase producing~     Enterobacteriaceae (CPE). compared to no intervention (current standard of care) in adult~     non-immunosuppressed patients .~   "
83609|NCT02472587|"~     The purpose of this study is to determine the percentage of women, among those attending our~     institute in order to do Pap test, suffering of chronic pelvic pain. To such purpose the~     patients will be submitted to questionnaires.~   "
83610|NCT02472574|"~     The purpose of this trial is to determine the optimal dose of rt-PA in the treatment of~     intracerebral hemorrhage (ICH) using a combination of minimally invasive surgery and clot~     lysis with rt-PA。~   "
83612|NCT02472548|"~     Administration of DPX-RSV(A), a Respiratory Syncytial Virus vaccine containing Respiratory~     Syncytial Virus (RSV) SHe antigen and DepoVaxTM adjuvant to healthy adults ≥50-64 years of~     age.~   "
83613|NCT02472535|"~     A 12-week, open-label, dose-escalating, phase 2 study to evaluate the effects of MBX-8025 in~     patients with Homozygous Familial Hypercholesterolemia (HoFH).~   "
83615|NCT02472509|"~     It is well established that hemolytic diseases predispose patients to the development of~     pigment gallstones. Gallstones are noted in at least 5% of children under the age of 10~     years, increasing to 40-50% in the second to fifth decades. The co-inheritance of Gilbert's~     syndrome increases the risk of cholelithiasis four to five-fold.~      In patients with chronic hemolysis, total bile lipid concentration is decreased and the total~     bilirubin to total lipid ratio is increased. This suggests that the conjugating capacity of~     hepatocytes is surpassed by the excessive amount of bilirubin resulting from hemolysis.~     Increased bilirubin monoconjugate and unconjugated bilirubin can precipitate in bile and form~     complexes with inorganic ions, mostly calcium, and develop into stones.~      Patients with hemolytic disorders can also develop biliary sludge, a suspension of~     precipitated particulate matter in bile dispersed in a viscous, mucin-rich liquid phase . The~     chemical composition of the precipitates correlates well with the composition of the~     associated stone and sludge often stands as a harbinger of future stone development.~      There is strong data suggesting a benefit in treating cholelithiasis with UDCA and also in~     preventing gallstone development in various high risk scenarios.~      There are several proposed mechanisms for the positive effect of UDCA in primary prevention~     of pigment stones. Mucoglycoproteins are present in significant amounts in black pigment~     stones and contribute to the matrix of gallstones. UDCA suppresses the secretion of protein~     and decreases the levels of various proteins in bile . It has also been suggested that~     increased colonic bile salt may solubilize unconjugated bilirubin and may prevent calcium~     complexing.~      There is no published data at present on the role of UDCA in prevention and treatment of~     cholelithiasis in hemolytic diseases. The investigators hypothesise that UDCA can be of~     benefit to patients with hemolytic disorders in the primary prevention of pigment stones,~     possible resolution of biliary sludge and existent stones, and reduction of symptomatic~     episodes of cholelithiasis.~   "
83616|NCT02472496|"~     The Korean Coronary Overlapping Stenting Registry is a multicenter database which includes~     percutaneous intervention using drug-eluting stents from cardiovascular centers in eight~     affiliated hospitals of The Catholic University of Korea~   "
83617|NCT02472483|"~     The purpose of this study is to determine whether a Cognitive and Behavioral group Therapy~     (CBT) + Mindfulness Based Cognitive Therapy (MBCT) decreased relapses and hospitalizations~     and improved outcomes (depressive and manic symptoms, self-esteem, and quality of life) in a~     large sample of refractory bipolar I patients on mood stabilizers.~   "
83618|NCT02472470|"~     Youth depression is a debilitating disorder that exacts enormous social, economic and~     personal cost. Unfortunately, treatments which are conventionally used to treat adult~     depression have often modest to no efficacy in youth and have side effects. Thus, there is a~     tremendous imperative to develop new treatments for youth depression. Investigators propose~     to examine the efficacy of a short form of repetitive transcranial magnetic stimulation~     (rTMS) for youth depression and examine its biological targets. This will be the first study~     examining the efficacy of a short rTMS protocol in youth diagnosed with depression who fail~     responding to or are intolerable to antidepressants. If the results are positive,~     investigators will have identified a novel treatment that may be both more efficacious,~     better tolerated and more acceptable treatment for youth depression. Finally, identifying the~     biological mechanisms leading to treatment efficacy will lead to more personalized treatments~     for youth depression and will be groundbreaking vis à vis understanding the mechanisms~     involved in this illness.~   "
83619|NCT02472457|"~     Crohn disease (CD) is an idiopathic, chronic, relapsing and remitting inflammatory condition~     of the gastrointestinal tract with a high risk for complications and need for surgical~     interventions, particularly in children. Immunomodulators and biologic therapies are~     effective at inducing and maintaining remission in pediatric CD, yet there is no proven~     strategy for reducing exposure to medications once sustained remission has been achieved.~     Diet has been proven to impact disease activity in CD and may allow for sustained drug-free~     remission. The primary objective of this study is to determine whether pediatric CD patients~     in long-standing remission remain in remission longer after stopping medications if they~     follow the Crohn's Disease Exclusion Diet (CDED). The hypothesis is that subjects on the CDED~     will have longer time-to-relapse as opposed to those on an unrestricted diet.~   "
83620|NCT02472444|"~     Taste perception plays an important role in maintaining nutritional balance. Gustatory evoked~     potentials (GEP) can be detected in response to an intermittent stimulation of the gustatory~     receptors by a primary flavour. GEP are non invaisve, painless and safe.~      The aims were to establish a reliable recording of GEP in Humans and to determine~     physiological variations of the gustatory evoked cerebral activity, by recording gustatory~     evoked potentials in different physiological situations (different intensities of taste~     solutions, after feeding or fasting, with different taste...). Healthy volunteers were~     included in this study. GEP were recorded in 9 cortical sites by EEG sensors (10/20 system),~     in front of the primary and the secondary gustatory cerebral areas, referenced against ear~     lobes.~   "
83621|NCT02472431|"~     Autologous adipose-derived regenerative cells (ADRC) extracted using Celution 800/CRS System~     (Cytori Therapeutics Inc) from a portion of the fat harvested from the patient's front~     abdominal wall. ADRC will be administered one-time intracavernosally. This is a single arm~     study with no control. All patients receive cell therapy.~   "
83622|NCT02472418|"~     Crossover study of DFN-15 dose A versus DFN-15 dose B versus Placebo in the treatment of~     migraine headaches.~   "
83623|NCT02472405|"~     This study aims to determine if the 595nm Pulsed dye laser, the combined 595/1064nm Multiplex~     laser or no treatment results in a better outcome in the quality of the surgical scar using~     the multiplex cynergy laser, starting treatment the day of suture removal.~   "
83624|NCT02472392|"~     The purpose of this study is to examine the toxicity of using allogeneic stem cell~     transplantation for treatment of subjects with relapsed or refractory ES and~     rhabdomyosarcoma. This is a nanrandomized two-arm study is designed to determine the safety~     and incidence of graft versus host disease (GVHD) in patients with relapsed, refractory~     Ewings sarcoma receiving related and unrelated, allogeneic stem cell transplants.~   "
83625|NCT02472379|"~     UCLA researchers looking for healthy females (age 60+) to participate in a study~     investigating how writing about your experiences may be related to your health.~      Once a week for 6 weeks, participants will write about their experiences and fill out online~     questionnaires. Participants will also come to the UCLA campus for blood draws and to fill~     out questionnaires 3 times: once prior to the 6-week writing period, once immediately after~     the 6-week period, and once 2-months after the writing period.~   "
83626|NCT02472366|"~     A phase 4 trial evaluating the effect and safety of ILUVIEN in chronic DME patients~     insufficiently responsive to available therapies.~   "
83627|NCT02472353|"~     The goal of this study is to determine if co-administration of metformin and doxorubicin in~     breast cancer patients receiving neoadjuvant or adjuvant therapy will reduce the number of~     patients who develop a significant change in left ventricle ejection fraction (LVEF).~   "
83628|NCT02472340|"~     In recent years, evidence has shown that mitochondrial dysfunction plays an important role in~     the development of age-related muscle decline that may lead to frailty.~      During aging, there is a progressive reduction in the cell's capacity to eliminate its~     dysfunctional elements by autophagy, as evidenced by the accumulation of oxidative damage and~     mutations in mitochondria and by the decrease in autophagic flux. In fact, it has been~     demonstrated that dysfunctional mitochondria can be specifically targeted for elimination by~     autophagy, a process that has been termed mitophagy.~      A major challenge in the clinic today is in the lack of validated tools, including~     biomarkers, to assess the decline in mitochondrial health associated with an impairment in~     muscle function. In the present study, the investigators will employ a battery of established~     and exploratory tests (clinical, physiological and molecular) to assess in vivo mitochondrial~     function and more specifically, the levels of mitophagy and autophagy, in the muscle of~     healthy and pre-frail elderly.~      It is anticipated that the results of this study will facilitate the rapid translation of~     interventions targeting mitophagy and autophagy for the improvement of muscle function.~   "
83629|NCT02472327|"~     Patient satisfaction after an unplanned cesarean section was studied and in the previous~     study it was noted that there were common themes that lead to patient dissatisfaction. The~     four common themes were: lack of trust regarding the indications for surgery, communication~     issues, loss of control, and fear during the situation. The purpose of this second phase of~     this study is to try and improve patient dissatisfaction by offering additional emotional~     support prior to the c/s with the hope of decreasing the trust issues toward physicians,~     decreasing the communication barriers, and decreasing the fear and loss of control. The~     additional emotional support that will be received prior to the cesarean section will be~     scripted based upon the findings of the investigators' prior study - the patient will be~     asked four questions and each question addresses the four themes that were noted in the~     previous study.~   "
83630|NCT02472314|"~     The purpose of this study is to compare the effect of liposomal Bupivacaine infiltration into~     the shoulder to continues nerve block with Bupivacaine on postoperative pain control and~     functional outcomes.~   "
83631|NCT02472301|"~     To determine if 12 months of legume-based complementary foods is effective in reducing or~     reversing EED and linear growth faltering in a cohort of Malawian children, aged 12-35 months~     to see if these improvements are correlated with specific changes in the enteric microbiome.~   "
83632|NCT02472288|"~     This study aimed to evaluate the effectiveness of adjuvant electroacupuncture therapy for the~     post-stroke patients with urinary retention under conventional treatments, compared with sham~     electroacupuncture.~   "
83633|NCT02472275|"~     This phase I trial studies the side effects and best dose of multitargeted tyrosine kinase~     inhibitor PLX3397 (PLX3397) when given together with radiation therapy and antihormone~     therapy in treating patients with prostate cancer that is at intermediate or high risk of~     spreading. Multitargeted tyrosine kinase inhibitor PLX3397 may stop the growth of tumor cells~     by blocking some of the enzymes needed for cell growth, and may also help the radiation~     therapy work better. Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens~     can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide~     acetate, goserelin acetate, or degarelix, may lessen the amount of androgens made by the~     body. Giving multitargeted tyrosine kinase inhibitor PLX3397 with radiation therapy and~     antihormone therapy may be a better treatment for prostate cancer.~   "
83634|NCT02472262|"~     To determine if 6 months of legume-based complementary foods is effective in reducing or~     reversing EED and linear growth faltering in a cohort of Malawian children, aged 6-11 months~     to see if these improvements are correlated with specific changes in the enteric microbiome.~   "
83635|NCT02472249|"~     Dr Rajan is investigating a new method to improve local treatment of liver cancer. There is~     evidence that a drug, norepinephrine (NE), has the ability to shrink down normal liver blood~     vessels, but leave tumor vessels wide open. In patients with primary liver cancer, NE will be~     injected directly in the artery that nourishes the liver and the tumor. Real time blood flow~     will be measured using an advanced CT scanner to demonstrate the NE effect on blood vessels.~     If Dr Rajan's hypothesis is confirmed, this drug has great potential to benefit patients~     during local delivery of chemotherapy in the liver artery, diverting it away from normal~     liver and towards the tumor, resulting in less complications and improved tumor kill.~   "
83636|NCT02472236|"~     To assess the effect of PEX168 doses on the pharmacokinetics of digoxin in healthy~     subjects.To provide a scientific basis for clinical drug combination of PEX168.~      To assess the safety of single doses of digoxin administered with and without PEX168~   "
83637|NCT02472223|"~     The primary aim of this pilot study is to generate data needed to design a definitive trial~     to compare the safety and efficacy of standard care with artificial tears vs. Betadine 5% (5%~     povidone-iodine) for the treatment of pink eye due to adenovirus. There is currently no FDA~     approved treatment for pink eye, a common and highly contagious eye infection caused by~     adenovirus. Standard care as recommended by the American Academy of Ophthalmology and~     American Optometric Association is instillation of artificial tears to relieve symptoms and~     possibly reduce the virus population. Betadine 5% is a commercially available, broad-spectrum~     antiseptic ophthalmic solution used for over 50 years to prepare the patient's eye and~     surrounding area for eye surgery. Because Betadine 5% kills bacteria and viruses, it may be~     useful in treating adenoviral conjunctivitis. Betadine 5% is inexpensive, safe, widely~     available, and immune to the development of bacterial/viral resistance. Betadine 5% has the~     potential to significantly impact the clinical management of pink eye worldwide.~      This pilot study has received funding from the National Eye Institute. Participants who meet~     eligibility criteria will be randomized using a masked randomization packet to receive~     one-time, in-office treatment with either artificial tears or Betadine 5%.~      Patients who agree to study participation will answer questions about their pink eye~     symptoms, medical and ocular history, have an eye examination and be tested to confirm pink~     eye due to adenovirus using a FDA approved point of care immunoassay. Participants testing~     positive for adenovirus will have a tear sample taken to measure viral load by qPCR.~     Randomization and a one-time treatment with either (standard care) artificial tears or~     Betadine 5% will be done on the first visit. Follow-up visits are at 1,4,7,14 and 21 days. At~     each visit, symptoms of pink eye are asked, a standardized study eye examination is given by~     the masked clinician and a sample of tears is taken to assess viral load by qPCR.~   "
83660|NCT02471924|"~     Spinal anesthesia is the main technique for caesarean section. This anesthesia is followed by~     a hypotension in 40% to 90% despite preventing tools. Hypotension is responsible of foetale~     and maternal suffering. It would be interesting to have a tool that could detect patient who~     are at risk to have hypotension.This study consist in measuring variations of under aortic~     velocity peak (ΔITVAo) which estimate the modification of the cardiac output by Trans~     thoraciq echography.~   "
83638|NCT02472210|"~     Most Parkinsonism related pain can be assigned to one or more of five categories:~     musculoskeletal pain, neuritic or radicular pain, dystonia associated pain, primary or~     central pain, and akathitic discomfort. In PD pain tends to affect the side of the body that~     was initially, or more severe affected by the motor symptoms. Botulinum toxins are an~     effective treatment modality for a growing number of neurological conditions. They have been~     studied for a variety of conditions associated with PD including dystonia, jaw tremor,~     apraxia of eyelid opening, camptocormia, dyskinesias, freezing of gait, sialhorrea,~     overactive bladder and constipation. There are no studies for the use of Botulinum Toxin for~     pain in PD. The investigators will perform a double-blind, randomized cross-over study~     evaluating the efficacy and safety of an individual pattern of BTXA injections targeted at~     painful muscles vs. placebo injection.~   "
83639|NCT02472197|"~     Intrauterine pathologies are currently treated by hysteroscopic resection. In this surgical~     procedure, the intrauterine pathology is resected by a transcervical approach in several~     fragments using a mono or bipolar cove after distension of the uterine cavity and by~     endoscopic control. The main risks of this surgery are: uterine perforation and OHIA~     (operative hysteroscopy intravascular absorption) syndrome. Hysteroscopic morcellators are~     new intrauterine devices, recently appeared on the French market.~      In comparison to classical resectors, morcellators have several theoretical advantages:~        -  A smaller instrument diameter with potentially a lower risk of uterine perforation and~          cervical laceration during the dilatation procedure,~        -  The use of physiological serum, eliminating the risk of neurological toxicity of~          glycine,~        -  The risk of electrical accident is canceled (internal or external burns due to leakage~          current),~        -  A decreased risk of air embolism, due to the absence of bubbles' production,~        -  The instrument is always under visual control, the perforation risk by the active~          instrument is therefore very limited,~        -  The vision is not obscured by the fragments or by the bubbles,~        -  The treatment of pre-ostial pathologies, not always easy in classical resections, could~          be facilitated,~        -  the absence of thermal effect, and therefore a potentially lower endometrial aggression,~          is interesting in women with reproductive desire,~        -  Absence of chips management, limiting the entry and exit movements in the uterine~          cavity, improving the vision, reducing the infectious and traumatic risks, specially~          uterine perforation and air embolism,~        -  Morcellation could preserve tissues for histological analysis of possible malignancy~          (compared to techniques using heat, coagulation, vaporization),~        -  Easy learning in comparison to the time-consuming learning of classical hysteroscopic~          resection,~        -  Generated additional cost could be partly amortized by reducing operating time and~          complications.~      It seemed useful to study this new technology.~      The primary purpose was to compare the time of hysteroscopic treatment of uterine polyps~     between a hysteroscopic morcellator the UNIDRIVE S III / DrillCut-X II-GYN-Shaver (Integrated~     Bigatti Shaver IBS), Storz®, and a conventional resectoscope.~      The secondary purposes were to compare the efficiency, complications and comfort of these~     techniques.~   "
83640|NCT02472184|"~     This study will look at the optimal order in which to perform concurrent office hysteroscopy~     and endometrial biopsy in female patients who present for evaluation of abnormal uterine~     bleeding at a fibroid and endometriosis treatment center.~   "
83641|NCT02472171|"~     The overall goal of the research study is to determine whether a high-fat meal causes~     postprandial (after meal) inflammation, and whether eating n-3 polyunsaturated fatty acids~     (PUFAs) or blueberries that are rich in anti-inflammatory polyphenols suppress the~     inflammation in healthy people.~   "
83642|NCT02472158|"~     The purpose of this study is to compare the use of chlorhexidine-gel-impregnated dressing and~     the transparent polyurethane film dressing as coverage of the site of insertion of central~     venous catheter, in the evaluation of catheter colonization in critically ill adults~     patients.~   "
83643|NCT02472145|"~     The primary objective of study Part A is to assess the safety of talacotuzumab (formerly~     CSL362) monotherapy and confirm the recommended Phase 2 dose (RP2D) in participants with~     acute myeloid leukemia (AML) for whom experimental therapy is appropriate. The primary~     objective of study Part B are to assess complete response (CR) rate and overall survival (OS)~     in participants with AML who are not eligible for intense induction chemotherapy and who are~     randomly assigned to receive decitabine plus talacotuzumab at the RP2D or decitabine alone.~   "
83644|NCT02472132|"~     Central venous catheter (CVC) is an essential tool in the management of both medical and~     surgical patients. Establishing venous access is critically important and is sometimes~     technically challenging. Among the many indications for point of care ultrasound (POCUS),~     ultrasound-guided venous catheter placement is well described and increasingly used. This~     study was designed to evaluate the utility of peri procedural transthoracic echocardiography~     (TTE) as a tool for positioning CVC and for ruling out complications.~   "
83645|NCT02472119|"~     Celiac disease is one of the most common forms of food intolerance (prevalence 1/200). The~     disease occurs in genetically predisposed individuals after ingestion of foods containing~     gluten. Celiac patients can suffer from severe malabsorption syndrome, mainly characterized~     by diarrhea and weight loss. The only therapeutic approach currently recognized is a~     life-long gluten-free diet.~      Specific regions of gluten molecule become recognizable by lymphocytes and activate them, due~     to changes made by tissue transglutaminase. These changes consist in the conversion of~     specific residues of glutamine into glutamic acid. The consequence is an increased binding~     affinity between gluten and histocompatibility molecule (HLA-DQ2), localized on the surface~     of the antigen presenting cells (APC); the exposure of the fragments of modified gluten on~     the surface of APC is a phenomenon that eventually activates T lymphocytes.~      Recent studies on modified gluten confirmed the hypothesis that it is possible to block the~     presentation of gluten to lymphocytes by means of lysine ethyl ester binding exclusively to~     those gluten regions responsible for lymphocyte activation.~      The enzymatic treatment is performed directly on flour instead of extracted gluten,~     maintaining the same anti-inflammatory effectiveness.~      The procedure uses a food-grade enzyme, the microbial transglutaminase (mTGasi) isolated from~     Streptoverticillium mobarensis, able to catalyze the formation of intermolecular~     cross-links that modify the functional properties of the products.~      Objective of the study is to validate the ability of the enzyme treatment of wheat flour with~     mTGasi and lysine ethyl ester to block the toxic effect of gluten in celiac patients.~   "
83646|NCT02472106|"~     This study is designed to monitor the safety and performance of the V8 balloon when used as a~     postdilatation balloon in self-expanding Transcatheter Aortic Valve Implantation (TAVI)~     device procedures. The study product is CE marked for balloon aortic valvuloplasty (BAV), and~     is being investigated for an expanded intended use.~   "
83647|NCT02472093|"~     The aim of the investigators study was to measure reductions in chronic pain in female~     patients with Fibromylgia comparing individual proprioceptive rehabilitation treatments with~     perceptual surfaces to a group exercises rehabilitation. Fibromyalgia is a generalized~     chronic pain condition that is usually accompanied by fatigue, sleep disturbance and~     psychological and cognitive alterations.~   "
83661|NCT02471911|"~     This study evaluates the addition of selinexor (KPT-330) to RICE chemotherapy in the~     treatment of relapsed and refractory aggressive B-Cell Lymphoma, with the goal of improved~     response rates (as compared to RICE chemotherapy alone).~   "
83648|NCT02472080|"~     Radioiodine refractory differentiated thyroid cancer is a rare tumor and therapeutic options~     are limited in this setting. Molecular targeted therapies have recently been developed for~     progressive disease and demonstrated clinical activity, especially with anti-angiogenic~     agents.~      For patients with contra-indication to these agents or in case of progression or toxicity~     during treatment, chemotherapy is usually proposed but this strategy has not been validated~     by prospective data.~      The investigators propose to conduct an open single arm phase 2 study to evaluate response~     rate according to RECIST 1.1 with GEMOX regimen (gemcitabine - oxaliplatin combination) for~     advanced radioiodine refractory differentiated thyroid cancer patients after anti-angiogenic~     agents or in case of contra-indication to anti-angiogenic therapy.~   "
83649|NCT02472067|"~     The main objective of this pilot project is to demonstrate the effectiveness of a~     psychologically-based physical therapy (PBPT) intervention for the prevention of disability~     in Active Duty Service Members who sustained a musculoskeletal injury (MSI) during deployment~     in support of combat operations on a carrier. This intervention is intended to optimize~     recovery and restore function in injured Active Duty Service Members.~      The three aims necessary to accomplish the main objective are:~        1. Demonstrate the feasibility of implementing PBPT on board a carrier;~        2. Document and compare risk factors related to disability from MSI aboard two carriers;~        3. Demonstrate the effectiveness of the PBPT intervention in a comparative effectiveness~          trial~   "
83650|NCT02472054|"~     The purpose of this project is to study the number of surviving patients until hematopoietic~     stem cell transplantation (HSCT) after first line treatment of hemophagocytic~     lymphohistiocytosis (HLH) by Alemtuzumab~   "
83651|NCT02472041|"~     This study evaluates the comparison of two of re-expansion pulmonary physiotherapy in~     patients with chest tube. The study group received intermittent positive pressure~     intervention and the control group received incentive spirometry intervention associated with~     manual operation.~   "
83652|NCT02472028|"~     The purpose of the study is to test the hypothesis of slowing the progression of White Matter~     Lesions (WML) by lowering blood pressure (BP) in patients with cognitive complaints and a~     moderate to high grade of WML on brain MRI.~   "
83653|NCT02472015|"~     Telemedicine may facilitate adequate treatment of Neuropsychiatric symptoms (NPS) by~     identifying underlying causes and tailoring a treatment plan (pharmacological or~     non-pharmacologic treatments including provision of staff education and support, training in~     problem solving, and targeted therapy directed at the underlying causes for specific~     behaviors).~   "
83654|NCT02472002|"~     MES-HT is a pilot multicenter prospective study conducted in transplant patients who~     developed severe coronary vasculopathy. A preparation of autologous mesenchymal cells of bone~     marrow is administered by endomyocardial injection, guided by the Noga® cardiac mapping~     system.~      The main objective is to determine the effect of the administration of autologous mesenchymal~     cells of the bone marrow by intramyocardial injection on myocardial perfusion in cardiac~     transplant patients with severe coronary vasculopathy.~   "
83655|NCT02471989|"~     The aim of this study is to determine the effects of a low Fermentescible Oligosaccharides~     Disaccharides Monosaccharides and Polyols (FODMAP) diet in patients with documented~     refractory GERD on proton pump inhibitor (PPI) therapy.~   "
83656|NCT02471976|"~     Rationale: Medicalized end of life rose profound society questions and debates. Major Laws~     and scientific society recommendations emerged from those reflections. These texts help~     withholding/withdrawing life-sustaining treatments allowing a palliative approach and to~     favor comfort treatments for end of life patients.~      Main Objective: To evaluate the impact of a procedure to support reflection on the level of~     therapeutic involvement for surgical patient (who undergone surgery or not) in ICU after~     having identified vulnerability criteria early.~      Secondary objectives: To assess the usual care of the control group and the impact of the~     procedure according to ICU type (medical, surgical, mixed); the characteristics of surgical~     patients concerned by a palliative strategy; the impact of an incentive approach on length of~     mechanical ventilation and length of stay in the ICU; To measure the extent of information~     collected concerning the collegial process; the impact of the procedure on caregivers'~     satisfaction; To count the number of identified conflicts Study type: Prospective,~     controlled, cluster randomized study of routine care Purpose: Study the implementation of the~     Act Leonetti released on 22 April 2005 calling for a compassionate approach and palliative~     care for patients at end of life.~      Inclusion criteria: Surgical patients (who undergone surgery or not) hospitalized in ICU~     during the study period Non-inclusion criteria: Patients hospitalized less than 24h;~     non-surgical patients; patients who don't need ICU care or surveillance; minors; brain-dead~     patients (at the time of admission) Primary endpoint: Rate of deaths with palliative strategy~     (withholding or withdrawing treatments) Randomization process: each center is randomized~     adjusting on type of ICU (medical, surgical, mixed) and number of annual hospitalization~     volume.~        -  Control group: ICU usual care~        -  Intervention group: vulnerability criteria lead to reflection on level of therapeutic~          involvement, with the help of a written guide.~      Number of patients: 2750 surgical patients Number of centers: 45 Study design: usual data~     will be collected in a secured web-based Case Report Form (CRF) at ICU admission and each~     time therapeutic strategy will change. Additional data will be collected for the intervention~     group according to the initial presence or the later apparition of predefined criteria, a~     standardized reflection procedure will start helped by the implementation of a guide for~     collegial approach and decision making.~      Length: 30 months~   "
83657|NCT02471963|"~     Empagliflozin may lead to improved vascular and endothelial function in the macro- (pulse~     wave reflection) and microcirculation (retinal circulation) and improve cardiovascular risk~     factors, imparticular by effectively controlling hyperglycemia, arterial hypertension and~     obesity.~   "
83658|NCT02471950|"~     There is no clinical way of assessing the depth of anaesthesia while patients are on the~     heart-lung machine. A new method of measuring the depth of anaesthesia using brainwaves~     called the Bispectral index (BIS) has been developed and its use in cardiac surgery is now~     widespread. However BIS is also altered by patients body temperature. As cooling is common~     during heart surgery the use of BIS to measure the depth of anaesthesia during heart-lung~     bypass remains controversial. This study aims to find out what depth of anaesthesia is~     produced according to BIS during heart lung bypass using a standard anaesthetic technique~     that utilises the anaesthetic isoflurane.~   "
83659|NCT02471937|"~     Streptococcus agalactiae (GBS) is the leading cause of neonatal septicaemia, meningitis, and~     pneumonia in the industrialized world. Early onset (EOD) and late onset (LOD) diseases are~     defined in neonates by their occurring within or after the first week of life, respectively.~     Molecular epidemiological studies have identified a capsular serotype III clone, referred to~     as CC-17 by Multi Locus Sequence Typing, as accounting for the vast majority of neonatal~     invasive diseases and for almost all cases of meningitis in LOD.~      The investigators working hypothesis is that host-environmental interactions may contribute~     to the colonization and persistence of the hypervirulent CC-17 GBS in the neonate. In this~     project the investigators will determine if reciprocal interactions between the intestinal~     microbiota and the innate and adaptive immune system may specifically facilitate the~     colonization of the neonate by the hypervirulent GBS CC-17 clone.~   "
83663|NCT02471885|"~     Cancer survival has improved steadily due to earlier detection and treatment. Despite the~     established efficacy of anthracycline chemotherapy, its damaging effects on the heart~     (cardiotoxicity) limits treatment and confers acute and long term adverse cardiovascular~     consequences. Protective strategies for the heart (cardioprotection) with iron binders~     (chelation), heart rate (beta blockade) and blood pressure (renin angiotensin inhibition)~     medications have demonstrated promise in adult cancer patients, but these treatments are~     typically prescribed only after significant changes in heart chamber size and pumping ability~     are detected by imaging investigations (myocardial dysfunction).~      Furthermore, these conventional therapies are constrained by important side effects that~     affect bone marrow, blood pressure, and the kidneys.~      Remote ischaemic conditioning (RIC) protects the heart by activating cell survival pathways~     through brief repeated inflations and deflations of a blood pressure cuff to limit blood flow~     temporarily (noninjurious ischaemia). These innate survival mechanisms prevent part of the~     cellular injury that occurs during the ischaemia reperfusion cascade during a heart attack~     (myocardial infarction). Ischaemia reperfusion injury also shares common biochemical pathways~     with anthracycline cardiotoxicity, and thus RIC may be a novel form of nonpharmacological~     cardioprotection that can be applied when undergoing anthracycline chemotherapy.~      The investigators propose a pilot single centre randomised controlled trial to investigate~     the effect of RIC on reducing heart muscle damage (myocardial injury) in~     anthracycline-treated cancer patients. The investigators will assess subclinical myocardial~     injury using high-sensitivity blood tests (troponin T levels) and advanced imaging~     techniques, monitor heart rhythm disturbances (cardiac arrhythmia) and analyse metabolic~     changes in urine and blood during chemotherapy, at specified time points, and follow up to 5~     years after completing chemotherapy treatment).~   "
83664|NCT02471872|"~     The BREATHE (Behavioral Research of Environment and Air Pollution Through Education) study is~     a pilot randomized control trial comparing the efficacy of a classroom-based intervention to~     no intervention in helping middle-school students understand and make behavioral decisions~     about air pollution. This study is designed to evaluate the effectiveness of the~     classroom-based intervention on knowledge of air pollution, understanding of air pollution~     sources, and behavioral choices made to reduce both contributions to air pollution and~     personal exposure to air pollution.~      It has been well established that pollution is a racial and economic issue. Low-income areas~     with populations of predominantly people of color tend to be those with the highest rates of~     pollution and the largest particulate exposure. Creation of and exposure to this pollution is~     a key issue for the health of inhabitants of these areas, and of those in the broader~     surrounding areas. By developing, and assessing the effectiveness of, the investigators hope~     that the BREATHE study will give the investigators insights into how to better combat this~     higher exposure and reduce the health risks for those in high pollution areas.~      The study will take place in 4 visits over a period of 12 months. The hypothesis is that the~     classroom-based intervention will be effective in leading to behaviors that will reduce~     exposure to air pollution.~   "
83665|NCT02471859|"~     This is a Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending, Single- and~     Multiple-Oral Dose, Safety, Tolerability, and Pharmacokinetic Study of GDC-3280 in Healthy~     Subjects.~   "
83666|NCT02471846|"~     This study will evaluate the safety, tolerability, and pharmacokinetics of the combination of~     GDC-0919 and atezolizumab in participants with locally advanced, recurrent, or metastatic~     incurable solid malignancy that has progressed after available standard therapy or for which~     standard therapy is ineffective, intolerable, or inappropriate. Participants will be enrolled~     in two stages, including a dose-escalation stage and an expansion stage.~   "
83667|NCT02471833|"~     The purpose of this study is to determine if Telmisartan, an FDA approved blood pressure~     medication, may also have beneficial effects on Alzheimer's disease prevention in African~     Americans, who are at high risk for Alzheimer's disease.~   "
83668|NCT02471820|"~     This study is to assess the efficacy and safety of lenalidomide in combination with~     adriamycin and low dose dexamethasone in newly diagnosed patients with symptomatic multiple~     myeloma as well as to collect information regarding the effect of this regimen on~     angiogenesis and bone remodeling of the study population.~   "
83669|NCT02471807|"~     The study is a multi-center, prospective, early feasibility study to measure individual~     patient clinical outcomes and effectiveness, evaluate the safety and function, provide~     guidance for future clinical study designs and development efforts of the Edwards FORMA~     Tricuspid Transcatheter Repair System.~   "
83670|NCT02471794|"~     The primary aim of this study is to examine the feasibility of implementing an evidence based~     patient engagement strategy, known as personalized health planning (PHP), in the context of a~     a shared medical appointment (SMA) for individuals with type II diabetes in a primary care~     setting.~   "
83671|NCT02471781|"~     The Zenith TX2 Low Profile TAA Endovascular Graft extended study is to collect confirmatory~     safety and effectiveness data. The Zenith TX2 Low Profile TAA Endovascular Graft is indicated~     for the treatment of patients with a descending thoracic aortic aneurysm or penetrating ulcer~     and has an anatomy suitable for repair.~   "
83672|NCT02471768|"~     Abstract~      Objectives:~      Primary: To study the association between central aortic blood pressure indices and coronary~     artery disease in patients undergoing elective angiography. Secondary: (a) To study whether~     any association exists between central aortic pressure indices and the incidence of major~     adverse cardiovascular events (MACE) in the same patients during a 6 month follow up period.~     (b) To study whether any association exists between the central aortic pressures and~     peripheral pressures.~      Methods: The investigators conducted a prospective observational study in consecutive~     patients undergoing coronary angiography. Central and peripheral pressures were invasively~     recorded and coronary artery disease (CAD) classified into obstructive and non-obstructive~     group. CAD severity was graded using the Gensini score and subjects were divided into~     tertiles. Patients were followed up and the role of central aortic pressure indices in the~     prediction of cardiovascular events were analysed.~   "
83673|NCT02471755|"~     This trial aimed at exploring the efficacy as well as safety of electro-acupuncture for MT~     symptoms.~   "
83674|NCT02471742|"~     Nipple areolar-complex (NAC) sparing mastectomy, extending the concept of skin-sparing~     mastectomy, allows to leave the nipple-areola complex intact and to provide a better cosmetic~     result. Large operable T2-T3 breast cancer (BC), treated with neoadjuvant chemotherapy, may~     theoretically appear suitable for this surgical option, alternative to conventional~     mastectomy or breast conserving surgery in case of unfavorable size of the breast, when a~     good response to neoadjuvant chemotherapy has been achieved.~   "
83841|NCT02469571|"~     Background Sepsis is a common disease leading to high morbidity and mortality. Gut microbiota~     and/or gut permeability may play a crucial role in the development of organ dysfunction.~      Hypothesis The ingestion of a multispecies probiotic in early sepsis is able to modulate gut~     microbiota and/or gut permeability.~   "
83675|NCT02471729|"~     Management of chronic heart failure (CHF) is a major public health problem. It is associated~     with high mortality, frequent hospitalization and represents a large cost to the health care~     system. Both pharmacological and non-pharmacological intervention haven't shown to be~     effective in reducing morbidity and mortality of these patients when able to modulate the~     activity of neuro-hormonal systems among them the sympathetic nervous system. Recent data~     have emphasized the potential role of sympathetic renal denervation in patient with~     hypertension. CHF per se but even more CHF associated with comorbity lead to significant~     increase level of sympathetic tone. This is largely induced by autonomic dysfunction such as~     chemo or baroflex abnormalities. These patients usually suffer from conditions which do not~     allow upgrading and adapting drugs to their sympathetic condition. Hence CHF patient with~     chronic kidney disease, anemia or both have markedly high sympathetic activity and cannot be~     exposed to higher level of RAS Blockers or beta blocker due to their renal dysfunction, they~     thus remain with an elevated sympathetic activity worsening symptoms and prognosis. Chronic~     heart failure affects around 100 million people worldwild imposing a significant burden on~     health care system throughout the world. Even though symptoms are improved by heart failure~     therapy, they remain significantly disabling for many patients. Chronic over activation of~     the sympathetic nervous system is a major component of heart failure and involves efferent~     and afferent pathways between brain and many organs. A new therapy directly targeting nerve~     traffic-renal artery denervation- has been shown to be effective in drug resistant~     hypertension, with an average drop in blood pressure of 33/12 mm hg.~      The cardiologists team of the private hospital Arnault Tzanck is willing therefore to conduct~     a study in 12 patients with chronic systolic heart failure undergoing bilateral renal~     denervation with an intensive protocol of observation and assessment compring a 3 day~     hospital stay post procedure 3 and 6 months of regular outpatient follow-up.~   "
83676|NCT02471716|"~     This is a phase 1/2 single arm, open-label, safety, tolerability, and PK study of FPA008 in~     PVNS/dt-TGCT patients. Patients will be enrolled into either Phase 1 (dose escalation) or~     Phase 2 (dose expansion) of the study, but not both.~   "
83677|NCT02471703|"~     This is a prospective, consecutive series, multicenter clinical study of clinical outcomes~     following total hip arthroplasty with the SMF stem.~   "
83678|NCT02471690|"~     The protocol describes a double-blind study to evaluate the Pharmacokinetics and safety of a~     new formulation of oritavancin by adjusting infusion time, concentration and~     reconstitution/administration solutions, of a single 1200 mg intravenous (IV) infusion of~     oritavancin~   "
83679|NCT02471677|"~     The purpose of this randomized controlled trial (RCT) is to compare a single injection of~     corifollitropin-alfa versus daily injections of follitropin beta regarding the number of~     oocytes retrieved, hormonal profile and follicle development in patients with high response~     undergoing ovarian stimulation for in vitro fertilization treatment using a~     gonadotropin-releasing hormone (GnRH) antagonist protocol combined with GnRH agonist trigger~     and cryopreservation of all embryos.~   "
83680|NCT02471664|"~     To evaluate safety and feasibility of Mitral Loop Cerclage(MLC) Annuloplasty with CSTV for~     repair of functional mitral regurgitation.~   "
83681|NCT02471651|"~     Laser photocoagulation and intravitreal anti-vascular growth factor injections are commonly~     used treatment options for individuals with diabetic macular edema. However, some patients~     continue to experience persistent diabetic macular edema and poor vision despite continued~     laser and/or anti-vegf therapy. Recent clinical trials suggest that due to inflammatory~     mediators dexamethasone intravitreal implant (0.7mg) may be a good alternative therapy for~     individuals unresponsive to laser photocoagulation or intravitreal anti-vascular growth~     factor injections. The purpose of this research study is to compare the effectiveness of~     using a dexamethasone steroid implant versus monthly intravitreal anti-VEGF injections for~     research participants with persistent diabetic macular edema (DME).~   "
83682|NCT02471638|"~     To assess the safety and performance of the PQ Bypass System to access, deliver guidewires~     and implant stent grafts for a percutaneous fem-pop bypass.~   "
83683|NCT02471625|"~     The purpose of this research study is to evaluate whether data made by the ClearView System~     can be used to detect whether someone has a traumatic brain injury and how severe the injury~     is.~   "
83684|NCT02471612|"~     To compare APACHE II and P-POSSUM scoring system in emergency laparotomy.~   "
83685|NCT02471599|"~     The effect of tonsillectomy therapy on IgA nephropathy is still controversial.Few~     prospective,randomized investigations have examined how tonsillectomy affects the shortterm~     and longterm renal outcome of IgA nephropathy.This is A prospective,randomized ,controlled~     study to explore the longterm effect of tonsillectomy for patients with IgA nephropathy.~   "
83686|NCT02471586|"~     To demonstrate the safety and efficacy of an OCT guided strategy for stent implantation.~   "
83687|NCT02471573|"~     To compare the effectiveness of freeze-all and subsequent frozen embryo transfer (freeze all~     protocol) with fresh embryo transfer (fresh ET).~   "
83688|NCT02471560|"~     The primary objective of the study is to determine if dimethyl fumarate (DMF) causes changes~     in the abundance and diversity of commensal microbiota. The secondary objectives of this~     study are as follows: To identify if there are differences in the gut microbiota composition~     between patients that do or do not develop gastro intestinal (GI) adverse events (AEs), both~     pre- and post DMF treatment and to examine if the resolution of GI AEs in DMF treated~     patients is reflected in the gut microbiota.~   "
83689|NCT02471547|"~     Transurethral Resection of Bladder Tumor (TURBT) is the initial treatment procedure for~     urinary bladder cancer. Recurrence rate during the first year ranges between 15-38% in case~     of low-intermediate disease. Current literature advocate using intravesical instillations of~     Mitomycin-C (MMC) immediately post TURBT in order to reduce the rate of recurrence.~      During the last decade, heated intravesical instillations have emerged as additional players,~     in the treatment of recurrent disease. By most cases, the heated intravesical instillations~     are given either by microwave hyperthermia (synergo®) or by conductive heat bladder wall~     thermo-chemotherapy (BWT).~      Previous reports suggest up to 59% reduction rate in recurrence following thermo-chemotherapy~     upon recurrent disease. These outstanding reduction results haven't convinced significant~     amount of urologists worldwide to use the intravesical instillation close after endoscopic~     resection as TURBT, probably due to the fear of MMC adverse effects in an operated area or~     the fear of complications due to perforated bladder. Preliminary results have suggested~     favourable outcome when MMC is used prior to TURBT [see publication]. To the investigators'~     knowledge no previous study has prospectively examined the effect of preliminary heated~     intravesical installation with BWT.~   "
83690|NCT02471534|"~     The purpose of this study is to evaluate predictability of an abdominal compression-induced~     change of blood pressure for fluid responsiveness in children.~   "
85177|NCT02452099|"~     The main aim of the study was to evaluate the clinical impact of different DMSO~     concentrations in cryopreservation mixture (5%, 7.5%, 10%) on reconstitution of hematopoiesis~     after autologous hematopoietic stem cell transplantation.~   "
83691|NCT02471521|"~     The purpose of this study is to find an optimal inspiratory pressure to provide adequate~     tidal volume and prevent gastric insufflation in pediatric patients.~      The children under 5 years old are randomly assigned to muscle relaxation group and~     non-relaxation group. For muscle relaxation group, routine anesthesia induction is performed~     with muscle relaxant and mask ventilation is started by pressure-controlled mechanical~     ventilation. Gastric auscultation and abdominal ultrasonography are performed simultaneously~     during mask ventilation to detect inflow of air. Initial inspiratory airway pressure is 10~     cmH2O and increased gradually by 2 cmH2O until gastric insufflation is detected by either of~     two methods. Tracheal intubation is done after detection of gas.~      For non-relaxation group, mask ventilation is performed in a same manner, without muscle~     relaxant. After detection of gas by any of the two methods, rocuronium 0.6 mg/kg is~     administered and tracheal intubation is performed.~   "
83692|NCT02471508|"~     Adolescent idiopathic scoliosis (AIS) is a prevalent disease that caused a lateral curvature~     on spine. Spine curvature increases in youths as puberty progresses. The recommended~     treatment for AIS is different depends on the spine deformity condition. For mild scoliosis~     (Cobb's angle ≤ 20°), only periodic observation is suggested. For scoliosis cases that the~     Cobb's angle ≤ 40°, a rigid brace treatment is recommended. A rigid brace that made by rigid~     plastic material restrict nearly all movements of the wearers, which caused irritation.~     Flexible brace is an alternative option, however, the efficiency of such treatment is~     questionable in terms of controlling the spine curvature progression.~      Biofeedback has proven to be effective for a number of physical, psychological and~     psychophysical problems. The basic aim of biofeedback therapy is to support a patient in~     realizing his/her self-ability to control specific psychophysiological processes.~      In this study, a biofeedback embedded tank-top with a specialized design for adolescents as a~     treatment option for AIS patients by monitoring the daily posture of the wearers.~   "
83693|NCT02471495|"~     This multicenter, prospective, single-arm, phase 3 study will assess the proportion of~     disease-free patients, starting from administration of the first study treatment to at least~     12-months after the first treatment, and up to 2 years (the latter only in patients choosing~     to participate in longer-term disease-free-survival data collection).~   "
83694|NCT02471482|"~     This study is intended to see the effect of Mozart music on oxygen content of brain of~     premature infants once they achieve corrected gestation of 28-32 weeks and are clinically~     stable. Each baby is its own control. Difference of Oxygenation of brain will be measured~     during period with and without music. In addition behavioural response of baby will be~     recorded during intervention~   "
83695|NCT02471469|"~     The primary aim is to show whether a reduction in tumor related mRNAs and a panel of selected~     miRNAS can be used to personalize enzalutamide therapy.~      Furthermore the aim is to explore the relation between drug exposure and the decrease in the~     selected biomarkers and treatment response.~   "
83696|NCT02471456|"~     Most patients undergoing coronary artery bypass grafting (CABG) will require long saphenous~     vein (LSV) harvesting from the leg. This has been reported to be associated with a~     significant morbidity (leg swelling, pain, infection, bruising, wound discharge) in up to 50%~     of patients. Endoscopic vein harvesting (EVH) which has been reported to be associated with a~     reduction in these complications was implemented within the investigators' service in 2012.~     Although some initial reports of concerns regarding graft patency when the LSV is harvested~     by EVH, NICE and European Cardiology Society (ESC/EACTS) guidelines 2014 supported the use of~     the EVH technology. Last year a service evaluation in the investigators' department showed~     significant cost benefit of EVH as compared to open vein harvest (OVH) in a matched group (50~     EVH and 50 OVH patients). The purpose of this study is to evaluate this group further to~     assess the incidence of MACCE (Major adverse cardiac and cerebrovascular event) and patient's~     quality of life (QOL) at least 1 year after their surgery. MACCE will be assessed by~     contacting the patient's GP and/or Cardiologist and QOL questionnaire (SF12v2) will be sent~     to patients along with a patient information sheet. It is estimated that data collection~     would be completed within 3 months of start.~   "
83697|NCT02471443|"~     To determine the quality of life following the radical excision of recto-vaginal~     endometriosis.~   "
83698|NCT02471430|"~     This study is a prospective, open-label, randomized, two-arm, dose-escalation exploratory~     pilot clinical trial involving HIV-1 infected participants treated with suppressive~     combination antiretroviral combination therapy (cART). The study will test whether combined~     treatment with the histone deacetylase inhibitor panobinostat and the immunomodulatory~     cytokine Interferon-alpha2a can reduce the residual reservoir of HIV-1 infected cells that~     persist during treatment with currently available antiretroviral drugs.~   "
83699|NCT02471417|"~     Acute consumption of dietary nitrate (as beetroot juice) has been shown to improve exercise~     capacity in athletes, healthy adults and subjects with both peripheral vascular disease or~     COPD. Many patients with dilated cardiomyopathy have reduced exercise capacity, The~     investigators hypothesized that acute nitrate consumption might increase incremental shuttle~     walk test (ISWT) distance in dilated cardiomyopathy subjects compared to a placebo beetroot~     juice.~   "
83700|NCT02471404|"~     This study is being carried out to see if dapagliflozin and dapagliflozin plus saxagliptin as~     an addition to metformin is effective and safe in treating patients with type 2 diabetes when~     compared to glimepiride (sulphonylurea) as an addition to metformin treatment.~   "
83712|NCT02471248|"~     A novel interactive exoskeleton robotic system with embedded force and motion sensors will be~     developed to facilitate walking of stroke patients with hemiparesis. The robot will~     synchronise with the gait pattern of the stroke patient to provide assistance in ankle~     dorsiflexion during swing phase. It is hypothesised that the robot can facilitate stable and~     longer walking distance for stroke patients with drop foot problem. It can be applied on~     unilateral side, which is suitable for stroke patients with hemiparesis. The whole system~     design is lightweight, compact, comfortable, and user-friendly in hospital or at home~     settings.~   "
83713|NCT02471235|"~     This study assessed whether a short course pulmonary rehabilitation programme with periodic~     reinforcement exercise training and phone call reminders would help to increase physical~     activity in COPD patients and also decrease readmissions for AECOPD.~   "
85216|NCT02451592|"~     The purpose of this study is to determine the risk factors for fungemia in a population of~     patients diagnosed with hematologic malignancies and eligible for chemotherapy.~   "
83701|NCT02471391|"~     This research will test the combination of two new drugs, called ibrutinib and ABT199, taken~     together in the treatment of Mantle Cell Lymphoma. Other studies have indicated the potential~     for these drugs to be used in the treatment of participants with Mantle Cell Lymphoma. In~     this study, the investigators will test the combination of the two drugs together, in order~     to determine what effects (good and bad) it has on mantle cell lymphoma.~      This study has two phases. The first phase is the Primary Evaluation Phase and will closely~     monitor the effects of ibrutinib and ABT199 for a period of 13 months. Participants who~     complete 13 months of treatment and continue benefiting from the study treatments will be~     allowed to continue both drugs until progression or intolerance in the Continuation Phase.~     The purpose of this phase is to provide patients with continuing access to both ibrutinib and~     ABT199. Patients will receive routine care from clinician, who will record any sideeffects~     that may be experienced.~      This is one of the first trials in the world to study the combination of ibrutinib and ABT199~     together. Therefore the effectiveness of the combination of the study drugs will be assessed,~     as will how they affect mantle cell lymphoma and how it develops resistance to the~     treatments. The investigators also do not know whether combining the two drugs together will~     cause unexpected side effects. Therefore, the study will monitor patients closely and perform~     scans, blood tests, bone marrow biopsies and other tests at regular intervals.~   "
83702|NCT02471378|"~     Background:~      - Malaria is a disease that affects many people in African countries. It is caused by germs~     that are spread by mosquito bites. It can be fatal if not diagnosed and treated right away.~     Children younger than 5 and pregnant women are most at risk to get malaria. Researchers want~     to create a vaccine that will prevent malaria infection during pregnancy.~      Objectives:~      - To create a vaccine that will prevent malaria infection during pregnancy. To assess~     possible vaccines using in-vitro tests with parasites taken from pregnant women.~      Eligibility:~      - Pregnant women ages 15 25~      Design:~        -  The study site is an area in Mali, West Africa.~        -  Participants:~        -  Will have blood drawn.~        -  Will give consent for the blood sample to be used for future research.~        -  May have a physical exam.~        -  Participants who have malaria or anemia will get treatment.~   "
83703|NCT02471365|"~     Background:~      - In a lifetime, a person may encounter tens of thousands of chemicals used as ingredients in~     the products they buy. It s not easy to measure them because the companies that sell the~     products don t have to tell the exact chemical ingredients. Researchers want to compare how~     existing methods (e.g., surveys and models) measure exposure to chemicals in personal care~     and household products.~      Objective:~      - To test and improve the ways that studies gather data about contact with chemicals found in~     consumer products.~      Eligibility:~      - Healthy women volunteers ages 35 74 who use at least 15 consumer products a day.~      Design:~        -  Participants will be screened with medical history, pregnancy test, smoking test, and~          blood sample. They will answer questions about their homes and products they use.~        -  Participation will last about 30 hours over 12 days.~        -  Researchers will:~        -  Place air samplers inside and outside participants homes for 10 days. One sampler will~          need to be plugged into an electrical outlet. It will make a low, continuous sound while~          in operation.~        -  Collect house dust samples and record all consumer products in the house.~        -  Visit the house daily to collect samples.~        -  Participants will:~        -  Give a blood sample at a clinic twice.~        -  Collect all urine voids for 10 days. They will label it and put it in a special cooler.~        -  Wear 4 small devices that measure air pollution, chemicals, location, and activity.~        -  Record what they eat and what consumer products they use. They will write these in a~          diary and <TAB>photograph them on an iPhone provided to them.~        -  On day 2 of the study, they will collect a duplicate sample of what they eat.~        -  Take iPhone videos of their use of certain products.~        -  Answer questions about chemical ingredients in their personal care products.~   "
83704|NCT02471352|"~     Background:~      - Skin disease can have many causes. It can have widespread consequences, and in rare cases~     can lead to death. Researchers want to determine the causes of various types of skin diseases~     and find a way to treat them.~      Objectives:~      - To determine the causes of various skin diseases and find ways to treat them.~      Eligibility:~        -  People ages 2 and older who have:~             -  A skin disease or at risk of developing a skin disease OR~             -  A family member of persons with a skin disease~        -  Healthy volunteers ages 2 and older~      Design:~        -  Participants will be screened under a separate protocol.~        -  Participants may take a survey about how their skin condition affects their quality of~          life.~        -  Participants will have a medical history and a physical exam including a detailed skin~          exam. Pictures will be taken of their skin to document any skin disease.~        -  Participants will have specimens collected. This may include:~             -  Several teaspoons of blood taken at each visit~             -  Stool samples~             -  Nail and body fluid (like saliva) samples~             -  Cheek swabs. The inside of the cheek will be scraped for about a minute in each~               direction to collect cells.~             -  Collection of skin samples with:~                  -  A swab (like a Q-tip)~                  -  Gently scraping skin to remove the outer layers of cells~                  -  Applying and removing 1-inch pieces of tape~        -  Participants may have up to 4 skin biopsies in 12 months, with 4 separate biopsies taken~          each time.~             -  An area of skin will be numbed with an injection.~             -  A piece of skin the size of a pencil eraser will be removed using a small~               instrument.~             -  A flat scar usually develops at the biopsy site.~   "
83705|NCT02471339|"~     Background:~      - People with neurofibromatosis type I (NF1) and plexiform neurofibroma (PN) tumors often~     have chronic pain that his hard to control. People usually take medicines for the pain, but~     they may not work well and might cause side effects. A new strategy called Acceptance and~     Commitment Training (ACT) may help these people cope with chronic pain. ACT focuses on things~     like values and living in the moment.~      Objective:~      - To see if Acceptance and Commitment Training improves pain coping in people with NF1 pain.~      Eligibility:~      - People age 16 34 who have NF1, 1 or more PN tumors, and pain that interferes with their~     daily functioning.~      Design:~        -  Participants will be screened with a physical exam, medical history, and questions about~          their pain.~        -  Participants will fill out questionnaires about their pain and feelings. Their heart~          rate will be measured via ECG.~        -  Participants will be divided into 2 groups randomly. One will wait 8 weeks.~        -  The other will start training right away.~        -  Participants will have 2 two-hour sessions with an ACT trainer. They will learn~          techniques for setting goals based on personal values and other ways to cope with pain.~          They will get a workbook and a CD to take home for practice.~        -  Participants will do practice exercises at home between sessions. They will get weekly~          emails with a practice exercise. They will join video chat sessions via home computer~          with their trainer.~        -  All participants will return to NIH after 8 weeks for questionnaires and an ECG. The~          wait group will then start training. They will return 8 weeks later for questionnaires~          and an ECG.~        -  Six months later, they will complete questionnaires from home by computer.~   "
83706|NCT02471326|"~     Background:~      - A combination of daily drugs (called cART) can keep human immunodeficiency virus (HIV) very~     low for a long time. But cART can lose effectiveness and cause permanent side effects. If~     treatment stops, HIV levels go up again. Researchers want to see if a new product can control~     HIV levels when a person is off cART.~      Objective:~      - To see if the new product VRC01 is safe and can control the HIV level in the blood when a~     person is not taking cART.~      Eligibility:~      - Adults ages 18-65 with HIV who are willing to interrupt their treatment for at least 24~     weeks.~      Design:~        -  Participants will be screened with:~        -  Physical exam~        -  Medical history~        -  Heart tests~        -  Blood and urine tests.~        -  Their HIV drugs may be switched. They will keep taking them until a few days after Visit~          1.~        -  Visit 1: Repeat screening procedures.~        -  Participants will also have genetic testing and leukapheresis. For this, blood will be~          removed through a needle in one arm and circulated through a machine that removes white~          blood cells. The rest of the blood is returned through a needle in the other arm.~        -  They will get the first study drug dose through a thin tube in an arm vein for about 1~          hour.~        -  For 24 weeks, participants will have 16 visits. They will have blood drawn every visit.~          At some visits they will repeat the screening procedures and get another VRC01 dose.~          They may have another leukapheresis.~        -  Four weeks after the last dose, participants will restart their cART. For 20 weeks, they~          will have monthly visits to repeat the screening procedures and discuss new symptoms.~   "
83707|NCT02471313|"~     Background:~      - Treatment for liver cancer can include surgery, transplant, and chemotherapy. It can also~     include other minimally invasive tumor treatments such as transarterial chemoembolization~     (TACE). TACE treatment for liver cancer helps control the cancer but is not considered a~     cure. Researchers want to learn more about the effects of TACE on liver tumors and~     surrounding tissue. To do this, they will use a positive emission test (PET) and a~     radioactive tracer called [18F] FMISO.~      Objectives:~      - To see if [18F] FMISO is useful for evaluating what happens to liver tumors and surrounding~     tissue after TACE.~      Eligibility:~      - People age 18 and older with liver cancer who have been approved to have TACE.~      Design:~        -  Participants will meet with a study researcher to see if they can take part in the~          study.~        -  Participants will have TACE under a separate NCI protocol or at a hospital other than~          the NIH Clinical Center.~        -  Before and after TACE, participants will have a CT and MRI of the abdomen. For these~          scans, they will lie in a machine that takes pictures of their body. They will also have~          blood tests and a physical exam.~        -  The [18F] FMISO imaging study will be performed at NIH only.~        -  Participants will have an intravenous catheter placed in their arm (if they do not have~          one). The [18F] FMISO tracer will be injected.~        -  Participants will have PET-CT scans. Each scan will take about 30 minutes.~        -  Some participants will also have [18F] FMISO and PET-CT scans before TACE.~        -  As part of standard care for TACE, participants will have CT and MRI scans at regular~          intervals. This will evaluate tumor response.~   "
83708|NCT02471300|"~     Background:~      Research shows that restricting calories has a positive effect on immune cell health in~     healthy people. Researchers want to learn if it will help people with asthma. They want to~     better understand how the body s immune response and lung function responds to short-term~     calorie restriction. For this, they want people to fast (no food or drink except water) for~     24 hours.~      Objective:~      To explore the benefits of calorie restriction in people with asthma.~      Eligibility:~      Healthy people ages 18 to 60 who have a history consistent with asthma and prior~     documentation of airflow obstruction or wheezing.~      Design:~        -  Participants who have taken part in asthma research at NIH will be screened with a~          telephone interview. All other participants will have a medical history, blood tests,~          and physical exam.~        -  Eligible participants will return to the NIH Clinical Center one morning for 2 hours.~          They will be fed breakfast. They may have blood and urine tests.~        -  Participants will then fast for 24 hours.~        -  Participants will return to the Clinical Center the next morning for 4 hours. They will~          have blood drawn. They will eat breakfast and then repeat blood draws 2.5 hours later.~          They will have a urine test.~        -  Blood and urine tests will be done at the end of the fast and after the meals to confirm~          that the participant fasted for the full 24-hour period.~        -  Participants will have lung function tests and exhaled gas measurements. A machine will~          measure the volume of air they can breathe out. Some gases in the breath increase with~          inflammation. Participants will breathe into a machine that analyzes the gases in their~          breath.~   "
83709|NCT02471287|"~     Background:~      Research has identified some of the genes involved in inherited eye diseases. But for many of~     these diseases, the genes are not yet known. Researchers want to try to find these genes.~     They also hope to learn more about how symptoms differ in people with similar gene changes.~      Objective:~      To learn more about genes involved in eye diseases.~      Eligibility:~      People who have a known or suspected inherited eye disease, and their relatives.~      Design:~        -  All participants will have a medical history, physical exam, and eye exam. They may have~          blood taken.~        -  Participants with an eye disease may have eye cell samples taken using a swab or biopsy~          procedure.~        -  Participants may have a skin biopsy. A (Omega)-inch piece of skin will be removed.~        -  Participants may have blood drawn and the red blood cells removed. The remaining serum~          will be made into an eye drop solution for the participant.~        -  Participants may provide samples of tears, urine, saliva, stool, hair, or inner cheek~          cells.~        -  Participants may have a retina test. They may also have a test that uses light to~          measure retina thickness.~        -  Participants may have an eye movement test. Electrodes will be placed on the skin next~          to both eyes.~        -  Participants may have a fluorescein angiography. A dye will be given through an~          intravenous line in the arm. A camera will take pictures of the dye as it flows through~          the eyes blood vessels.~        -  Participants may have microperimetry. They will sit at a computer screen and press a~          button when they see a light.~        -  Participants may have an eye movement test. They will wear contact lenses or goggles and~          watch a series of spots on a computer screen.~   "
83710|NCT02471274|"~     To evaluate the effect of mild, moderate, or severe hepatic impairment on the~     pharmacokinetics (PK) of a single dose of 400 mg sotagliflozin (2 x 200-mg tablets) compared~     with healthy, demographically-matched subjects.~   "
83711|NCT02471261|"~     Elastography as Gouty Arthropathy Outcome (EGO), a pilot study.~   "
83714|NCT02471222|"~     This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group~     study of ADS-5102 extended release (ER) capsules, an investigational formulation of~     amantadine, dosed once daily at bedtime for the treatment of walking impairment in MS.~     ADS-5102 is designed to be administered once daily at bed time, ADS-5102 achieves higher~     plasma amantadine concentrations in the early morning, sustained throughout the afternoon,~     and lower concentrations in the evening when patients are sleeping. ADS-5102 is designed to~     deliver its primary treatment effect during the day, and potentially reduce the adverse~     events of immediate-release amantadine when the patient is asleep.~   "
83715|NCT02471209|"~     To evaluate the effects of sevoflurane on hepatic blood flow (HBF) and hepatic arterial~     buffer response (HABR) in infants with obstructive jaundice by Doppler ultrasound.Twenty-five~     infants with biliary atresia (1-3 months-of-age) scheduled for a Kasai procedure were~     enrolled. portal vein blood flow (PBF), hepatic arterial blood flow (HABF) and hepatic blood~     flow (HBF) were measured by Doppler ultrasound before induction, and after inhalation of 2~     and 3% sevoflurane.~   "
83716|NCT02471196|"~     This study evaluates the effect of ORM-12741 on agitation/aggression symptoms in Alzheimer's~     disease. Two thirds of the patients will receive ORM-12741 and one third will receive~     placebo.~   "
83717|NCT02471183|"~     This study enrolls patients with pulmonary arterial hypertension (PAH) treated with inhaled~     treprostinil. During the study, the treatment with inhaled treprostinil will be tapered off~     and simultaneously replaced with an oral treatment (selexipag) targeting the disease in a~     similar way. The purpose of the study is i) to investigate the safety and tolerability of~     oral selexipag in patients who transition from inhaled treprostinil, ii) to investigate the~     effects of oral selexipag on PAH severity and exercise ability before and after transition,~     and iii) to gain new information about the patients experience taking oral selexipag compared~     to inhaled treprostinil. Study participants may stay in the study until the FDA has granted~     marketing authorization.~   "
83718|NCT02471170|"~     The purpose of this study is to collect blood samples to detect potential markers of~     pancreatic cancer in the blood and link these findings to medical and health information.~     Information from this study may help to provide insight into the detection of pancreas cancer~     in the blood before it can be found by other methods or provide a method of monitoring the~     status of pancreatic cancer throughout a treatment course. Another purpose of this study is~     to collect blood to create a biobank.~   "
83719|NCT02471157|"~     An observational trial to determine whether preoperative hormonal status predicts outcomes of~     oncologic surgery.~   "
83720|NCT02471144|"~     This is a multicenter, randomized, double-blind, placebo- and active-controlled (etanercept~     in single blinded arm) study in pediatric subjects aged 6 years to less than 18 years with~     severe chronic plaque psoriasis. Approximately 160 subjects aged 6 years to <18 years will be~     enrolled, of which at least 30 will be 6 years to <12 years old. It is expected that subjects~     will be enrolled at approximately 70 study sites worldwide.~   "
83721|NCT02471131|"~     Atrial fibrillation (AF) is the most common cardiac arrhythmia with a lifetime risk of~     developing AF of 1 in 4 people aged over 40. Stroke remains the most feared complication of~     AF with an increase in risk by 5-fold, and is the leading cause of morbidity and mortality.~     The left atrial appendage (LAA) is the origin for more than 90% of the emboli in non-valvular~     AF. The WATCHMAN™ Left Atrial Closure Device (WATCHMAN Device, Boston Scientific) reduces the~     risk of stroke by closing off the LAA. During hybrid procedures for AF, LAA occlusion with~     epicardial devices is known to be difficult and not free of risks.It thus will be interesting~     to study the safety and feasibility of endocardial WATCHMAN Device implantation in a hybrid~     ablation approach.~   "
83722|NCT02471118|"~     This is a Canadian randomized, double-blind, placebo-controlled, multicenter study designed~     to evaluate the clinical efficacy and safety of adalimumab versus placebo when used to treat~     subjects with a diagnosis of osteoarthritis of the knee, and with clinical features of~     inflammation, whose pain persists despite receiving maximum tolerated doses of conventional~     therapy.~   "
83723|NCT02471105|"~     This cross-over study will investigate the efficacy and safety of BIMMD and TUDPF in a~     clinical setting.~   "
83724|NCT02471092|"~     The purpose of this study is to develop and test modified milk protein products to determine~     the effects of amino acids on food intake, satiety, insulin secretion and glucose control by~     insulin-independent action in healthy adults.~   "
83725|NCT02471079|"~     Rationale:~      The number of breast cancer (BC) patients at risk for long-term radiation-induced health~     problems is increasing, as their outcome is improving due to intensified treatment regimens,~     such as new systemic approaches and radiotherapy. Therefore, identifying BC survivors with~     the highest risk for radiation-induced health problems is crucial for developing strategies~     for primary and secondary prevention, which may contribute to healthy ageing.~   "
83726|NCT02471066|"~     The management of functional psychogenic movement disorders (FNPMD) is challenging for~     neurologists and psychiatrists and only comprehensive multidisciplinary treatment programme~     can be worthwhile for these patients (Moene et al 2002). Recent functional magnetic resonance~     imaging studies have demonstrated abnormalities in motor control at cortical level,~     hyperactivity of limbic system and disturbance of connectivity between these two systems~     leading to a lack of self-agency, (Voon et al 2010,2011).Two recent studies suggested a~     possible therapeutic effect of transcranial magnetic stimulation (TMS) in FNPMD (Dakotakis~     2011, Garcin, 2013).~      In this protocol our objectives are twofold :~        1. to compare the effect of 5 consecutive daily sessions of rTMS on FNPMD in a double-blind~          randomized controlled study~        2. to study the effect of 3 weekly hypnosis sessions combined with rTMS in FNPMD~   "
83727|NCT02471053|"~     As the numbers of cancer survivors grow, the long-term adverse effects of cancer therapy are~     becoming increasingly apparent. Most prominent are the toxic effects on the heart~     (cardiotoxicity) which may lead to cardiac dysfunction and increased risk of cardiovascular~     disease (CVD). The investigators hypothesize that an individualized aerobic training program~     for cancer patients receiving active treatment will be both feasible and safe and will result~     in improvements in overall levels of physical activity and quality of life.~      Feasibility will be assessed by evaluating the recruitment, adherence and attrition rates,~     along with program safety. Efficacy will be assessed by evaluating changes in health-related~     outcomes.~   "
83728|NCT02471040|"~     This study is designed to examine the value of infusing BHB in type 1 diabetic subjects~     during experimentally induced hypoglycemic episode in conjunction with testing of cognitive~     function. This will lay the basis for subsequent trials exploring the novel use of~     therapeutic doses of oral ketone formulations that are currently under commercial~     development, which could serve as adjunct therapies to protect the brain from hypoglycemia in~     type 1 diabetic subjects experiencing recurrent hypoglycemia.~   "
83729|NCT02471027|"~     This study is a registration study.The main research: the curative effect of neoadjuvant~     chemotherapy in the treatment of ⅠB2 and ⅡA2 locally advanced cervical cancer.Research group:~     the neoadjuvant chemotherapy in combination with cervical cancer radical hysterectomy.Control~     group:cervical cancer radical hysterectomy directly.Main observation indexes is overall~     survival and disease-free survival.~   "
83730|NCT02471014|"~     Pneumococcal infections are a leading cause of adult and childhood hospitalization and death.~     It has been shown that obese individuals are at higher risk for this bacterial infection. As~     a result, investigators will vaccinate obese individuals to see if they are offered the same~     level of protection from the vaccine as normal-weight individuals. The vaccine used for this~     particular bacterial infection is called Pneumovax 23.~      The purpose of this study is to compare how body mass index affects protection that the~     vaccine provides against these bacteria.~      Primary Hypothesis: Levels of protection from the vaccine are no different in pre- and post-~     vaccination in healthy BMI individuals and obese individuals.~   "
83731|NCT02471001|"~     In the last few years, anaesthetic agents, Isoflurane used in heart surgery have shown some~     benefits to reduce the risk of heart muscle damage. Many research studies have been conducted~     to reveal the benefit relationship between Isoflurane and the risk of heart muscle injury~     during heart surgery. However, there is a knowledge gap regarding the optimal level of~     Isoflurane concentration to confer the benefit of heart muscle-protective properties.~     Therefore, this study is conducted to answer that question by measuring the Isoflurane~     concentration in the blood vessels. It also assesses whether Isoflurane concentration in the~     blood is correlated to the oxygenator exhaust level of Isoflurane in the heart-lung machine.~   "
83732|NCT02470988|"~     The purpose of the study is to investigate the process of symptom change in Cognitive~     Behavioural Analysis System of Psychotherapy (CBASP), and how the individual components of~     the therapy affect this change in individuals with chronic depression.~   "
83733|NCT02470975|"~     Children with newly diagnosed cancer and their parents will be contacted and invited to~     participate. Upon agreement, children will be interviewed, both parents will fill out~     questionnaires and be additionally interviewed. Using a 3-wave longitudinal design, mainly~     self-reported parental we-appraisals and we-disease-appraisals, couple dyadic coping (DC) and~     parent-child DC during a course of 12 months will be examined. Additionally, during brief~     separate interviews, the parents' speech will be coded for we-appraisals and expressed~     emotion regarding the other partner and the child. Findings will provide information on how~     family variables affect child QoL over 12 months.~   "
83734|NCT02470962|"~     This study evaluates the function of the heart in young patients with muscular dystrophy type~     Duchenne or Becker. Participants have their hearts examined at regular intervals by~     ultrasound (echocardiography) and cardiac magnetic resonance imaging.~   "
83735|NCT02470949|"~     This project will investigate the influence of experimentally manipulated perceived social~     standing on eating behavior and obesity risk.~   "
83736|NCT02470936|"~     A randomized controlled trial of a technology-based lifestyle intervention vs. usual care~     among men with low-risk prostate cancer to determine the acceptability and feasibility of the~     intervention and the effect of the intervention on behavior change related to exercise, diet,~     and not smoking.~   "
83737|NCT02470923|"~     The objective of the study is to assess the effect of in-hospital intensive counseling and~     NRT (nicotine replacement therapy) vs. usual care, on smoking cessation or enrollment to~     smoking cessation behavioral intervention.~      This is prospective randomized clinical trial. The study population will include smokers~     subjects admitted to internal medicine departments at Soroka University Medical Center.~      The study population will be divided randomly into three arms according to intervention~     intensity (ratio 1:1:1).~   "
83738|NCT02470910|"~     This research study is evaluating whether a standard prostate MRI examination can improve~     radiation therapy planning for prostate cancer.~   "
83739|NCT02470897|"~     This phase I/II trial studies the side effects and best dose of stereotactic body radiation~     therapy while using intensity-modulated radiation therapy (IMRT) planning to help avoid~     radiation to normal tissue in patients with prostate cancer. Stereotactic body radiation~     therapy is a specialized radiation therapy that sends x-rays directly to the tumor using~     small, high doses of radiation over several days and may cause less damage to normal tissue.~     This treatment schedule allows for a higher dose of radiation to be administered over a~     shorter overall treatment period in comparison to standard radiation therapy.~   "
83740|NCT02470884|"~     A prospective multi-center, single arm feasibility study to assess the safety and performance~     of the Boston Scientific Fully Absorbable Scaffold.~   "
83741|NCT02470871|"~     The purpose of this study is to investigate the pharmacokinetics (PK) and safety of rVIIa-FP~     (CSL689) in a total of 10 to 16 male or female adults with inherited coagulation factor VII~     (FVII) deficiency. Subjects will receive a single dose of their routine FVII replacement~     product (ie, either recombinant activated coagulation FVII [rFVIIa, eptacog alfa (activated)]~     or plasma-derived FVII [pdFVII]) as a comparator, and will then be randomly assigned to a~     single low dose or a single high dose of the study product CSL689 (8 subjects per CSL689 dose~     level). Serial blood samples for PK analysis will be taken up to 24 hours after the eptacog~     alfa (activated) or pdFVII injection, and up to 48 hours after the CSL689 injection. Subject~     safety will be routinely monitored throughout the study.~   "
83742|NCT02470858|"~     The study is designed to test the hypothesis that the addition of a protease inhibitor to~     dual NS5a-NS5B nucleoside prodrug analog will enhance antiviral efficacy and hence shorten~     the treatment duration to 3 weeks.~   "
83743|NCT02470845|"~     The aim of this study is to investigate the efficacy and safety of Tian Jiu in the treatment~     of allergic rhinitis compared with placebo and waitlist patients in Hong Kong.~   "
83746|NCT02470806|"~     The aim of this study is to compare the clinical efficacy of two types of NPWT systems;~        -  tNPWT systems that has successfully completed a coding verification request with CMS and~          has the following capabilities (e.g., range of negative pressure, connective tubing,~          canister, foam or gauze filler, and approved for home use) and,~        -  a portable, canister-less, battery operated, disposable single-use NPWT system (PICO) to~          see if there are any observed differences with regard to the clinical efficacy of the~          two devices.~   "
83747|NCT02470793|"~     To assess and compare the complications and results of different lamellar endothelial~     keratoplasty techniques and its variations.~   "
83748|NCT02470780|"~     This study investigates the effect of treating Small Intestinal Bacterial Overgrowth (SIBO)~     in patients with Parkinson's Disease (PD). It will test the hypothesis that treating SIBO~     with the antibiotic rifaximin will improve motor complications in previously SIBO-positive PD~     patients.~   "
83749|NCT02470767|"~     describe the sociodemographic and clinical characteristics of patients diagnosed with~     non-valvular atrial fibrillation (NVAF) at risk of stroke or systemic embolism on~     anticoagulant therapy who have changed their therapeutic regimen, due to any clinical~     situation, based on the doctor's routine clinical practice and are currently on treatment~     with a direct oral anticoagulant (DOAC)~   "
83750|NCT02470754|"~     The purpose of this study is to learn more about nicotine exposure and the safety of~     electronic cigarettes (EC). It will focus on the areas that are thought to most closely~     relate to the addictive potential of EC, namely: (1) EC as nicotine delivery devices,~     covering issues of nicotine intake and pharmacokinetics, temporal patterns of use and~     titration of nicotine; and (2) subjective effects of EC use, including relationship of use to~     reward, withdrawal and craving.~   "
83751|NCT02470741|"~     PLUM evaluates the drug letrozole as a treatment for uterine fibroids. This study is a~     randomized, blinded, placebo-controlled trial of oral letrozole among premenopausal women~     with symptomatic uterine fibroids. Participants will be randomly assigned in a 1:1 ratio to~     either oral letrozole 2.5mg/day for 6 months (Group A) or intermittent dosing with letrozole~     2.5mg/day and an identical placebo capsule (Group B).~   "
83752|NCT02470728|"~     Pain is a symptom that drives hospital admissions, and pain management is required by most~     patients during their hospital stay. Further, the use of medications such as opioids can lead~     to upward-spiraling doses, especially among chronic pain patients whose resource utilization~     rates are high. Many initiatives aim to reduce the costs of these high-resource utilizing~     patients. One exciting aspect of improving the management of pain is that this may help~     prevent patients from ever becoming high-cost in the first place. The purpose of this study~     is to examine the impacts of an early intervention pathway, in comparison to the current~     standard of care, for the treatment of pain in opioid tolerant patients. It is hypothesized~     that patients randomized to the early intervention pathway, in comparison to the control,~     will lead to decreased costs of care, a reduction in opioid usage within 3 and 6 months, and~     decrease in hospital readmission rates.~   "
83753|NCT02470715|"~     The primary aim of this study is to identify drivers of cancer by performing comprehensive~     genetic, proteomic, and metabolomic characterization of patient samples as a basis for~     understanding the underlying cause of disease.~   "
83754|NCT02470702|"~     This protocol describes a double-blind study to evaluate the safety and pharmacokinetics of~     multiple IV doses of 1200 mg ORBACTIV (oritavancin) in healthy subjects.~   "
83755|NCT02470689|"~     Epidermolysis bullosa simplex type Dowling-Meara (EBS-DM) is one of the most severe subtypes~     of EBS. Blisters and erosions of the skin and mucous membranes upon minor trauma are the~     consequence of dominantly inherited mutations in either the keratin 5 (K5) or keratin 14~     (K14) gene, which encode proteins constituting the intermediate filament (IF) network in~     basal keratinocytes . Autosomal dominant mutations lead to a conformational change and an~     increased self-aggregation of the protein. Upon stress, aggregates present in the periphery~     of the cytoplasm, subsequently leading to the disintegration and collapse of the IF network.~     Clinically, patients suffer from blistering of the skin and mucous membranes upon minor~     trauma, resulting in an impaired life quality due to pain and pruritus . In vitro studies on~     Dowling-Meara keratinocytes revealed a significant upregulation of the pro-inflammatory~     cytokine interleukin-1beta (IL-1ß). Apart from paracrine effects of IL-1ß upon wounding (e.g.~     attraction of lymphocytes, activation of dermal fibroblasts), IL-1ß also activates~     keratinocytes via the cjun N-terminal kinase (JNK) stress pathway. The activation of this~     pathway leads to the activation of a number of transcription factors and the enhanced~     transcription of a number of genes, like matrix metalloproteinases, kallikreins, but also~     IL-1ß itself and K14 . Interestingly, this state of activation is constitutive and was also~     found in keratinocytes from non-lesional sites. It seems that the upregulation of IL-1ß and~     K14 in the presence of dominant Dowling-Meara mutations, results in a positive feedback loop,~     potentially aggravating the EBS-DM phenotype. This was strongly corroborated by the fact that~     when impairing IL1ß signaling, using IL-1ß neutralizing antibody (IL-1Ab) or the small~     molecule diacerein, expression levels of IL-1ß and K14 decreased and keratinocytes were much~     less susceptible to heat shock in vitro . Furthermore, activation levels of JNK widely~     correlated with expression levels of K14 and IL-1ß. (Wally V et al, 2013). These findings led~     to the hypothesis that blocking IL-1ß will also lead to an amelioration of the EBSDM~     phenotype in effected patients. Based on previous in vitro findings diacerein was chosen to~     be topically applied in a pilot study with five patients suffering from EBS-DM. In that study~     , each participant received 1% diacerein-cream for one armpit, and placebo for the other~     (randomized withdrawal). The number of blisters was reduced significantly (left: -78%; right:~     -66% of baseline) within two weeks and remained significantly below the initial level even~     during withdrawal in four patients. These findings pointed to a relevant effect of diacerein~     and provide important information for our confirmative study.~      Diacerein is a component of the rhubarb root, which is reported to block the release of~     active IL-1b by inhibiting plasma membrane-bound IL-1 converting enzyme . Diacerien is~     already approved for systemic application in osteoarthritis . In general, small molecules~     (SM) are low molecular weight compounds with biological functions that can influence~     molecular processes. They allow a symptomatic treatment, offering a short-term benefit for~     patients in terms of an amelioration of the phenotype. Although this kind of treatment does~     not correct genetic alterations, it can still be highly beneficial by damping down disease~     symptoms, thereby increasing life quality and minimizing secondary manifestations.~      It is important to emphasize that besides dressings, there are currently no other treatments,~     therefore, investigators do not prevent an accepted treatment for the patient and there is no~     risk for the participant. The treatment will be given only to the armpits although the~     disease can involve other areas, so stopping dressings in the armpits during the study does~     not risk the patient. Should there be any deterioration of the patient, whether it is related~     to the treatment with diacerein or not, investigators will stop the use of diacerein.~   "
83756|NCT02470676|"~     The purpose of this randomized control trial is to determine whether cervical pessary plus~     vaginal progesterone is superior to vaginal progesterone alone in decreasing preterm delivery~     rate, and improving perinatal outcome, among women presenting with an asymptomatic~     mid-pregnancy short cervix, in singleton and twin gestations.~      All women with singleton or twin pregnancies undergoing routine ultrasonography up to 24~     completed weeks of gestation (for examination of fetal anatomy and growth) and diagnosed with~     cervical length of ≤25 mm in singleton, or ≤38 mm in twins, will be invited to participate in~     the clinical trial.~      Women who meet eligible criteria will be invited to participate in the clinical trial.~      Women will be randomly assigned into one of the following groups: group A (vaginal~     progesterone) or group B (vaginal progesterone + pessary).~      Follow-up visits for ultrasound assessment of fetal growth and cervical length will be~     carried out every two weeks until 37 weeks of gestation.~   "
83757|NCT02470663|"~     Patients diagnosed with, or in risk of osteoporosis regularly take calcium dietary~     supplements, although their contribution to BMD maintenance, prevention of bone loss or~     reduction of the risk of fracture is questionable. Freshwater crayfish rely on amorphous~     calcium carbonate (ACC), a thermodynamically instable and very rare biomineralized polymorph~     of calcium carbonate, as the main mineral in the exoskeleton and in their temporary storage~     organ, the gastrolith. The study hypothesis is that amorphous calcium carbonate (ACC) will~     have an advantage over calcium carbonate in improving BMD of pediatric IBD patients with~     reduced BMD. The investigators will include children 10-18 years old with IBD and reduced~     bone density to recieve regular calcium or amorphic calcium for 12 months with follow up of~     bone density and confounders as disease activity and medications.~   "
83758|NCT02470650|"~     The main objective of this study is to know the efficiency (costeffectiveness) at 48 weeks of~     initiation of antiretroviral treatment. three strategies of treatment.~   "
83759|NCT02470637|"~     Primary Objective:~      To assess the dose-response pattern of the glucose consumption (GIR-AUC0-end) of 3 different~     single doses of Afrezza inhaled Technosphere insulin and of 3 single doses of subcutaneous~     (SC) insulin lispro in a euglycemic clamp setting.~      Secondary Objectives:~      To assess the dose proportionality of insulin exposure (INS-AUClast) of 3 different single~     doses of Afrezza inhaled Technosphere insulin and of 3 single doses of SC insulin lispro in a~     euglycemic clamp setting.~      To assess the pharmacodynamic (PD) characteristics of 3 different single doses of Afrezza~     inhaled Technosphere insulin and of 3 single doses of SC insulin lispro in a euglycemic clamp~     setting.~      To assess the pharmacokinetic (PK) characteristics of 3 different single doses of Afrezza~     inhaled Technosphere insulin and of 3 single doses of SC insulin lispro in a euglycemic clamp~     setting.~      To assess the safety and tolerability of 3 different single doses of Afrezza inhaled~     Technosphere insulin.~   "
83761|NCT02470611|"~     In the past few years, studies have evaluated the effect of systemic use of sodium~     alendronate, especially in the treatment of structural bone defects caused by periodontal~     diseases. This study evaluated the effects of non-surgical periodontal treatment associated~     with the topical application of 1% sodium alendronate on clinical and topographical~     parameters. Chronic periodontitis patients were recruited for the present study and were~     monitored at 3 and 6 months after baseline examinations. A placebo gel was used as control.~   "
83762|NCT02470598|"~     The aim of this study is to observe the effect of adapted APD (aAPD) on maintenance and/or~     improvement of the hydration status of more than 250 PD patients, and to observe the~     tolerability of the therapy over a long period.~   "
83763|NCT02470585|"~     The focus of this study is to evaluate the efficacy, safety, and tolerability of veliparib in~     women with previously untreated, Stage III or IV, high-grade serous, epithelial ovarian,~     fallopian tube, or primary peritoneal cancer.~   "
83764|NCT02470572|"~     A multi-site, randomized-read order, retrospective, paired-design evaluation of the Omnyx™~     Integrated Digital Pathology (IDP) system with de-identified and previously signed-out cases~     from all major organ systems. Pathologist will read and diagnose cases on a conventional~     light microscope and on the Omnyx™ IDP system for Whole Slide Images (WSI) with a randomized~     read order. College of American Pathologists (CAP) cancer protocol checklists will be used to~     capture diagnostic reporting.~      Diagnoses rendered by site Reading Pathologists will be captured on CAP checklists and~     compared directly to the Ground Truth (GT) diagnosis for both modalities.~   "
83765|NCT02470559|"~     This phase I trial studies the side effects and best dose of activated T-cell therapy when~     given together with low-dose aldesleukin and sargramostim in treating patients with ovarian,~     fallopian tube, or primary peritoneal cancer that is stage III-IV, has not responded to~     previous treatment, or has come back. Activated T cells that have been coated with~     bi-specific antibodies, such as anti-cluster of differentiation (CD)3 and anti-human~     epidermal growth factor receptor 2 (HER2), may stimulate the immune system in different ways~     and stop tumor cells from growing. Aldesleukin may stimulate white blood cells to kill tumor~     cells. Colony-stimulating factors, such as sargramostim, may increase the production of blood~     cells. Giving activated T-cell therapy with low-dose aldesleukin and sargramostim may be a~     better treatment for ovarian, fallopian tube, or primary peritoneal cancer.~   "
83766|NCT02470546|"~     Primary aim:~      -To assess the effect of metformin use on the treatment of minimal hepatic encephalopathy in~     patients with liver cirrhosis.~      Secondary aim:~      -To evaluate if metformin is a safety drug in patients showing liver cirrhosis.~   "
83767|NCT02470533|"~     Rationale:~      This study will compare head to head in patients with hepatocellular carcinoma (HCC)~     ineligible for surgery or radiofrequency ablation, the standard treatment arm, transarterial~     chemoembolization with drug-eluting beads (TACE-DEB), with the experimental arm, stereotactic~     body radiation therapy (SBRT). The investigators hypothesis is that the time to progression~     is more favorable after SBRT than after TACE-DEB. The expected time to include the required~     patients for this trial will be four years.~      To the best of the investigators knowledge this study will be the first in the world that~     will compare both techniques in a randomized trial.~      Objective:~      To assess the time to progression after TACE-DEB and after SBRT in a comparable population of~     patients diagnosed with HCC.~      Study design:~      Randomized, prospective, open-label, and phase II study.~      Study population:~      Patients diagnosed with HCC, Child-Pugh grade A, one to three tumors, cumulative diameter ≤~     6cm, and ≥ 18 years old.~      Intervention:~      Patients with HCC will be randomized to receive the standard treatment, TACE-DEB loaded with~     doxorubicin or the experimental arm, SBRT.~      Main study parameters/endpoints:~      The primary endpoint of this study will be time to progression, defined as time from~     randomization to radiological progression.~      Secondary endpoints will be:~        -  Time to local recurrence~        -  Response rate (complete and partial response)~        -  Overall survival~        -  Toxicity~        -  Quality of life.~   "
83768|NCT02470520|"~     The aim of this study is to measure plasma levels of essential vitamins, trace elements and~     amino acids in critically ill patients with severe AKI. In patients who are treated with~     continuous renal replacement therapy, we plan to evaluate whether there are any additional~     losses of nutrients into the filtrate.~   "
83769|NCT02470507|"~     The immune response to kidney damage during acute kidney injury (AKI) is an important~     contributor to the prolonged lack of renal function and progression of kidney injury. Most~     data related to intrarenal and interorgan pathways in AKI stem from animal research with~     sometimes conflicting results. Accurate evaluation of these processes in humans and~     identification of early diagnostic tools are critical for the development of strategies to~     prevent and attenuate AKI-related morbidity and mortality in patients.~      The aim of this study is to evaluate immune function and miRNA expression in hospitalised~     patients with and without AKI.~   "
83770|NCT02470494|"~     The EarLens System is an assistive hearing device that is intended to provide amplification~     for the treatment of patients with sensorineural hearing impairment. The purpose of the~     proposed study (Extended Investigation under the Continued Access Policy) is to continue to~     allow access to the investigational medical device with the collection of device utility and~     clinic process-flow data while the marketing application is under review at the FDA.~   "
83771|NCT02470481|"~     The purpose of this study is to conduct full psychometric testing of the Early Arthritis for~     Psoriatic Patients (EARP) questionnaire in Australian, Korean and Chinese populations~   "
83772|NCT02470468|"~     The purpose of the study is to compare efficacy of DCVAC/LuCa + chemotherapy +/- immune~     enhancers vs. chemotherapy alone in patients with stage IV NSCLC, as measured by progression~     free survival (PFS).~   "
83773|NCT02470455|"~     The study was conducted to find out any possible effect of Atorvastatin on glycemic~     parameters in prediabetic patients.~   "
83774|NCT02470442|"~     The purpose of this study is to characterize the airway responses to desflurane during~     maintenance of and emergence from anesthesia in children whose airways were supported with~     laryngeal mask airways (LMAs).~   "
83775|NCT02470429|"~     The purpose of this study is to compare SYSTANE® HYDRATION to Hyabak 0.15% based on total~     ocular surface staining scores (TOSS) at Day 42.~   "
83776|NCT02470416|"~     Little is known about the prevalence of small bowel polyps in patients with sporadic~     Duodenal/Ampullary polyps. The investigators aim to investigate the prevalence of small bowel~     polyps in patients with sporadic (ie not related to FAP or PJS) duodenal/ampullary adenomas~     by performing small bowel capsule endoscopy and comparing the results to those acquired from~     a control cohort undergoing VCE for accepted indication at our centre.~   "
83777|NCT02470403|"~     A 12-week study to assess LIK066 effect on body weight in diabetics, prediabetics and~     normoglycemic patients with elevated body mass index (BMI)~   "
83778|NCT02470390|"~     A partially randomized, open-label, 3-way crossover, single-center, systemic and CSF PK and~     bioavailability study in healthy volunteers.~   "
83779|NCT02470377|"~     The goal of this study is to determine whether external neuromodulation using repetitive~     transcranial magnetic stimulation (rTMS) can reduce the perception of self-motion that is~     experienced by individuals with mal de debarquement syndrome (MdDS). Mal de debarquement is~     translated as the sickness of disembarkment, and refers to the chronic feeling of rocking~     dizziness that occurs after exposure to passive motion. Treatment for MdDS is limited and~     morbidity is high. The goal of the study is to determine whether rTMS can suppress the~     rocking dizziness of MdDS and to determine whether imaging and electrical biomarkers can aide~     in more effective targeting. The investigators will make correlations between functional~     magnetic resonance imaging (fMRI), electroencephalography (EEG), and specific clinical~     features to determine whether functional connectivity between particular hubs in the brain~     correlate with clinical improvement.~   "
83780|NCT02470364|"~     The purpose of this study is to translate and culturally adapt the MGQOL-15 (health-related~     quality of life scale for myasthenia gravis) for use with French-speaking patients in France~     and to evaluate its psychometric properties to ensure reliability and validity.~   "
83781|NCT02470351|"~     This study aims to describe in depth the CNS, CNS HIV reservoir and CNS viral rebound in~     consenting SEARCH 019 subjects prior to, during and after the SEARCH 019 study intervention~     (VHM + ART or ART only), at 1) baseline, 2) end of study intervention and start of ART~     interruption, 3) viral rebound (if occurring) or mid-way during observed ART interruption,~     and 4) at the end of ART interruption. Study SEARCH 026 itself does not employ any~     therapeutic interventions. However, consenting subjects will participate in lumbar puncture,~     non-contrast MRI + MRS, and neuropsychological testing at at least three and at most four~     time points. Any of the 15 subjects to be enrolled in SEARCH 019 may consent to study SEARCH~     026 participation and hence a maximum of 15 subjects may enroll. As this is a sub-study, data~     will be shared from study SEARCH 019 and no interventions (venipunctures) will be repeated~     unnecessarily.~   "
83782|NCT02470338|"~     This study is to show that the investigators believe the Modified Brostrӧm Procedure (MBP)~     can be completed without a routine ankle arthroscopy. Routine ankle arthroscopy, if~     determined not to be necessary in all cases, is a waste of resources in terms of operating~     room, surgeon, and staff time as well causing an increase in hospital financial expenses.~     Most importantly, this procedure is morbid. Ankle arthroscopy forces a patient's foot into~     distraction for up to one hour, exposes the patient to potentially longer anesthesia exposure~     that is unnecessary, increases infectious risks, and requires exposure at the portal sites~     near superficial nerves.~   "
83783|NCT02470325|"~     A clinical trial is planned to study the effects of cannabis on dystonia and spasticity in~     children with neurological diseases. The clinical trial will include 40 children divided into~     two groups: children with spasticity and dystonia due to cerebral palsy, and children with~     spasticity and dystonia due to genetic neurodegenerative diseases. Each group will be~     randomly divided into two arms and will receive Avidekel cannabis oil 6-to-1 ratio of CBD to~     THC or enriched Avidekel cannabis oil 20-to-1 ratio of CBD to THC. During the study, various~     variables will be collected including: medication intake, spasticity, dystonia score, pain~     scale, restlessness scale, quality of life measures, safety tests, side effects, and an~     addiction test. The investigators hypothesize that cannabis consumption will reduce dystonia~     and spasticity in children with motor disability related to genetic neurodegenerative~     diseases and cerebral palsy and as a result improve motor function, non-motor functions and~     quality of life.~   "
83784|NCT02470312|"~     The goal of this registry/observational study is to collect data on the clinical utility of~     MediGuide™ system in cardiac resynchronization therapy (CRT) implantation and~     electrophysiology (EP) procedures.~   "
83785|NCT02470299|"~     There is a move towards personalized medicine in cancer care, and significant effort is~     underway to evaluate new targeted therapeutics for the treatment of ovarian cancer. One way~     to identify potential new drug targets is by screening a drug library to determine whether~     drugs in the library target key kinase or enzymatic sites in cellular signaling pathways.~     Previous preclinical work and pilot studies demonstrated that ketorolac (a type of~     non-steroidal anti-inflammatory drug) inhibits GTPase activity in ovarian cancer cells~     retrieved from the post-operative peritoneal cavity.~      The purpose of this study is to confirm that this inhibitory effect is ketorolac driven and~     not a specific effect of the post-operative peritoneal compartment.~   "
83786|NCT02470286|"~     This study is a block-randomized, double-blind, placebo-controlled, single/multiple-dose,~     dose-escalation, Phase I clinical study to investigate the pharmacokinetics and~     safety/tolerability of SA001 in healthy male volunteer.~   "
83787|NCT02470273|"~     The purpose of this study is to calculate the sensitivity and specificity of a novel imaging~     device and associated software algorithm in detecting early stage melanoma versus nevi of the~     skin. The instrument, which was invented by the PI, for the purposes of this study, will be~     loaned to three external (to Rockefeller) institutions and used on patients who are scheduled~     for biopsy of pigmented lesions. The purpose of correlating the output screening result of~     the novel device and the output diagnosis of the gold standard histology analysis procedure~     is so that these two diagnoses can be compared to generate the number of true positives, true~     negatives, false positives and false negatives for the novel device. The purpose of~     disseminating the device to the external institutions is to achieve the appropriate power~     such that the specificity can be evaluated at 99% sensitivity. The rationale for the power~     needed in the study is that in order to be clinically useful, the device needs to be~     extremely sensitive (i.e. 99%) because false negative diagnosis is a dangerous situation,~     leading to potential progression of melanoma, the most deadly form of skin cancer.~   "
83788|NCT02470260|"~     Pre-diabetes, type 2 diabetes, and their related conditions, adiposity and insulin~     resistance, are more prevalent in minorities Northern Manhattan compared to the general~     population of the United States. Despite knowledge of the main biologic determinants of these~     conditions (high caloric intake and sedentarism) the prevalence of these conditions continue~     to increase. In addition, these conditions can cause mental health problems including~     increased depressive symptoms and cognitive impairment. Thus, the investigators decided to~     conduct a community based study of middle aged Hispanic men and women aged 50 to 64 years at~     baseline in order to:~        1. Document the prevalence and incidence, of pre-diabetes, diabetes, overweight, obesity,~          and associated conditions (e.g. dyslipidemia, hypertension).~        2. Study how social determinants of health (SDOH) affect these conditions.~        3. Study the consequences of these conditions on aging and mental health outcomes,~          including cognitive impairment.~   "
83789|NCT02470247|"~     Diagnostic imaging for vascular investigations and endovascular procedures frequently require~     the use of contrast medium. Besides contrast medium-induced hypersensitivity, an acute kidney~     injury can appear: the contrast-induced nephropathy (NPCI).~      NPCI is associated with an increase of patients' morbidity and mortality. One of the~     conventional methods proposed to limit this NPCI is an oral administration of~     N-acetylcysteine (NAC) associated with hydration performed 12 hours before and 12 hours after~     the injection. However, in some patients this method cannot be performed due to a high risk~     of heart failure although they are generally at high risk of NPCI.~      Recently, it has been shown, in a randomized trial, that remote ischemic preconditioning~     (several cycles of upper-arm ischemia-reperfusion with a pressure cuff inflator) associated~     with hydratation and NAC reduced the occurrence of NPCI after a coronary angiography as~     compared with NAC and hydration only. .~      We hypothesized that the use of RIPC in patients at high risk of NPCI and who cannot receive~     NAC and hydratation (e.g. patients with aortic stenosis and eligible for Transcatheter Aortic~     Valve Implantation (TAVI)) could be promising.~   "
83790|NCT02470234|"~     To assess the pharmacokinetics of a single dose of Aptensio XR® (methylphenidate~     hydrochloride extended-release) capsules under fed conditions in male or female children 4 to~     under 6 years of age with ADHD.~   "
83791|NCT02470221|"~     This study is aim to assess the effect of goal-directed intraoperative fluid therapy on~     patient's postoperative incidence rates of complications, length of hospitalization and~     hospitalization cost.~      This is an observational study followed cohort study design, due to the two therapies were~     not randomized assigned to the two cohorts. The details are described as follow.~   "
83792|NCT02470208|"~     The purpose of this study is to evaluate the ability of the T-SPOT.CMV assay to determine~     immune competence against CMV infection in stem cell transplantation.~      To determine the utility of the T-SPOT.CMV assay used before transplantation to determine~     immune competence against subsequent CMV reactivation and to determine the utility of the~     T-SPOT.CMV assay used after transplantation to determine immune competence against subsequent~     CMV reactivation.~   "
83793|NCT02470195|"~     Difficult airway management is a crucial point that may influence outcomes of patient in this~     critical situation. Education for this topic is of main importance for resident of~     anesthesiology. Procedural simulation workshop allows participant to use device dedicated to~     difficult airway management. Investigators included this workshop to a state education~     program of anesthesiology resident in second year and compared to their homonym in another~     state where no specific organized workshop is integrated to the education program.~   "
83794|NCT02470182|"~     The purpose of this study is to learn more about breathing disorders during sleep. The~     investigators want to learn how breathing sounds made during sleep relate to breathing~     disorders during sleep.~   "
83795|NCT02470169|"~     Four hundred and fifty women with endometriosis will be divided into 3 equal groups using~     computer generated random numbers: Group 1 will have up to 4 stimulated intrauterine~     insemination (IUI) cycles, group 2 will have up to 4 unstimulated cycles, women who do not~     become pregnant after the 4 cycles in groups 1 and 2 will be advised to have regular~     intercourse at the expected time of ovulation. Group 3 will be the control group will be~     advised to have regular sexual intercourse at the time of ovulation for 4 months~   "
83796|NCT02470156|"~     This 12-month randomized trial is designed to evaluate the impact of low intensity~     (quarterly) versus high intensity (monthly) wellness coaching programs on women's success~     achieving individual health goals related to active living and healthy eating and changes in~     these health behaviors over time.~   "
83797|NCT02470143|"~     The pilot study will investigate the usability of a mobile cycling application in a cardiac~     patient population during a one month study period.~      The application's effectiveness regarding ability to reduce fear and increase motivation to~     exercise will be assessed.~   "
83798|NCT02470130|"~     Resident in advanced medical training participated to high fidelity simulation education~     program in Lyon. Alternatively 1 or 2 resident act during a scenario while the others observe~     in a teletransmission closeby room. Debriefing follows the critical scenario in witch~     resident are involved. The investigators are testing the effects of five minute of~     conversational relaxation before the debriefing on the anxiety level and memorization of key~     points each scénario on participant and observer.~   "
83799|NCT02470117|"~     This study evaluates the efficacy of alginate-based reflux suppressant and~     magnesium-aluminium antacid gel for treatment of heartburn in pregnancy. Half of the~     participants will receive alginate-based reflux suppressant, while the other half will~     receive magnesium-aluminium antacid gel.~   "
83800|NCT02470104|"~     The investigators hypothesize that children receiving human milk will maintain a greater~     diversity of helpful bacteria in their gut and have lower levels of inflammatory proteins in~     the blood compared with children not receiving human milk.~   "
83801|NCT02470091|"~     This phase II trial studies how well denosumab works in treating patients with osteosarcoma~     that has come back (recurrent) or does not respond to treatment (refractory). Monoclonal~     antibodies, such as denosumab, may block tumor growth in different ways by targeting certain~     cells.~   "
83802|NCT02470078|"~     The purpose of this study is to evaluate whether pharyngeal electrical stimulation in~     addition to standard care can enhance swallowing recovery in severely dysphagic stroke~     patients post extubation compared to sham treatment plus standard care.~   "
83804|NCT02470052|"~     This is a multicenter,single-arm,open-label study designed to evaluate improvement of lung~     function and safety after treatment with OL-BF-001 for severe emphysema.~      OL-BF-001 consists of a bronchial valve, deployment catheter, loader and airway sizing kit. A~     bronchial valve is a small, umbrella-shaped, one-way valve that is placed inside the airways~     of one lung. It is used to redirect air from the less healthy to the more healthy parts of~     the lung. This helps to reduce over-inflation and may improve overall lung function and~     quality of life for people living with emphysema.~   "
83805|NCT02470039|"~     This trial is conducted in Europe. The aim of this trial is to compare NNC0123-0000-0338~     (insulin-338) in a tablet formulation and insulin glargine in combination with metformin with~     or without DPP-4 inhibitor in subjects with type 2 diabetes currently treated with oral~     antidiabetic therapy~   "
83806|NCT02470026|"~     This study investigates influences of nordadrenergic activity on cognition in patients with~     major depression regarding influences of early life stress.~   "
83807|NCT02470013|"~     The aim of this study is to assess the benefit of a 3-month intervention with oral~     nutritional supplements (ONS) in older ambulant patients with reference to functional~     limitations and quality of life as well as the consumption of health care resources.~   "
83808|NCT02470000|"~     Myofascial pain syndrome (MPS) is characterized by single or multiple trigger points (TrP) in~     taut bands within the affected muscles. Chronic MPS over neck is prevalent and responsible~     for markedly loss of work-day and a reduction of quality of life.~      Intravascular laser irradiation of blood (ILIB) involves in vivo illumination of the blood by~     low-level laser light through an optical fiber inserted in a vein. Researches disclosed that~     ILIB reduced blood viscosity, enhanced erythrocyte deformity, and increased oxygen saturation~     in blood. However, no research studies the effectiveness of ILIB to treat MPS.~      Real-time sonoelastography (RTS) and shear wave velocity (SWV) are used to detect the~     stiffness of skeletal muscles. RTS is displayed as a color-coded graphic to represent the~     relative stiffness of structures. For a given material, faster SWV indicates the greater~     stiffness. To our knowledge, only one research using RTS and SWV to study MPS.~      To elucidate the effectiveness of ILIB to treat chronic MPS over neck, and the validity of~     RTS and SWV for MPS, we conducted this study.~   "
83809|NCT02469987|"~     Double-blind, single-dose, three-treatment, parallel group design PK comparability study of~     MYL-1402O solution manufactured for Mylan compared to US and EU marketed Avastin® solution~     (bevacizumab).~   "
83810|NCT02469974|"~     To determine the safety of the approach of giving RUXOLITINIB before and after an autologous~     stem cell transplant, as measured by graft failure or death.~   "
83811|NCT02469961|"~     The standard hospital procedure calls for the patient to undergo Interscalene block under~     ultrasound with or without nerve stimulation guidance prior to going to operating room (OR).~     The block utilizes a 40 ml mixture of 0.5% Ropivacaine and Lidocaine 1.5%. At this time the~     patient receives preliminary sedation with Midazolam 1mg IV and Fentanyl 50 mcg IV. The~     participant is then brought to the OR and prolonged sedation is initiated, randomly using~     either Dexmedetomidine or Propofol.~      The primary objective of the present study is to use Dexmedetomidine for sedation, and~     compare the outcomes with Propofol sedation. The investigators will enroll 50 patients for~     this study.~      Our hypothesis is that Dexmedetomidine will cause fewer episodes of intermittent apnea, and~     reduced need for supplemental medication for sedation, compared to Propofol~   "
83812|NCT02469948|"~     Stroke may result in lower extremity spasticity, which interfere with motor voluntary~     function and activities of daily living. Botulinum toxin type A (BTX-A) has been shown to~     improve lower extremity spasticity of stroke patients. There are no researches to compare the~     efficiency of BTX-A injection by different guidance methods in the deep muscles of lower~     extremity for stroke patients. The aims of investigator's study were to compare the~     effectiveness of BTX-A injection by different guidance methods (palpation of anatomical~     landmarks, ultrasonography direct) in deep spastic muscles of lower extremity for stroke~     patients with varus spasticity and spastic claw toes , and to study the correlation between~     muscles spasticity and elastic properties by the sonoelastography/acoustic radiation force~     impulse imaging and follow the change of elastic properties in spastic muscles after BTX-A~     injection. We will enroll 80 hemiplegic stroke patients with varus spasticity / spastic claw~     toes and duration more than 6 months. Under different guidance methods (palpation of~     anatomical landmarks, electric stimulation, ultrasonography direct and indirect methods),~     BTX-A will be injected to the flexor digitorum longus and posterior tibialis muscles. If the~     patients have moderate hallucis spasticity, flexor hallucis longus muscle will be injected.~     The BTX-A dose is 50 units for each muscle. Outcome measures include Modified Ashworth Scale,~     Brunnstrom stage, muscle power, range of motion, the visual analog scale of pain, Stroke~     Impact Scale, Barthel index and lower extremity function tests, balance test, Goal Attainment~     Scale, sonoelastography and acoustic radiation force impulse imaging. All the assessments~     will be performed before BTX-A injection and followed up at 1 months, 2 months, 3 months and~     6 months after injection. After performing all the assessments, investigator will investigate~     the efficiency of BTX-A by different guidance methods.~   "
83813|NCT02469935|"~     Aims: To prospectively investigate the accuracy of surgeon-performed ultrasound for the~     detection of gallstones.~      Methods: 179 adult patients, with an acute or elective referral for an abdominal ultrasound~     examination, were examined with a right upper quadrant ultrasound scan by a radiologist as~     well as surgeon. The surgeons had undergone a four-week long education in ultrasound before~     participating in the study. Ultrasound findings of the surgeon were compared to those of the~     radiologist, using radiologist-performed ultrasound as reference standard.~   "
83814|NCT02469922|"~     Open multicentric study assessing predictive value of 18-FDG PET (SUV max) at 20 Gy during~     radio-chemotherapy, on the loco-regional control after 2 years~   "
83815|NCT02469909|"~     The investigators propose to examine the feasibility and safety of immediate (single stage)~     decannulation in adult patients in a controlled randomized trial. Patients who will be found~     fit for decannulation after an otolaryngologist and intensive care specialist assessment will~     be randomized into two groups: immediate decannulation and gradual decrease in cannula size.~     Both groups of patients will be monitored after decannulation and in the outpatient clinic~     for any complications following the procedure.~   "
83816|NCT02469896|"~     This research study is being done to find out if tocilizumab, also known as Actemra™, can~     help with Amyotrophic Lateral Sclerosis (ALS). The investigators also want to find out if~     tocilizumab is safe to take without causing too many side effects.~      Currently ALS has no cure and 2 modestly effective treatment to slow the progression of the~     disease. Although not the initial cause of ALS, the immune system plays a role in the death~     of motor neurons. The immune cells that participate in this process are stimulated by a~     substance called interleukin-6 (IL-6) whose effect is blocked by tocilizumab and thus, may~     slow the death of motor neurons and slow the disease.~   "
83817|NCT02469883|"~     This study is conducted to assess the maximum tolerated dose (MTD) and dose-limiting toxicity~     (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of~     Sinotecean.~   "
83818|NCT02469870|"~     The evaluation of the program efficacy will be conducted via a randomized control study with~     136 parents of children aged 3-8 who have autism. Investigators will test whether, compared~     to a content comparison group (CC), administration of the APT program over a 3-week~     intervention period (a) improves child behaviors, (b) increases perceived quality of life,~     (c) decreases parental stress, (d) increases positive parenting practices, and (e) increases~     parent knowledge of evidence-based support practices.~   "
83819|NCT02469857|"~     The purpose of this study is to determine whether AB103 is safe and effective in the~     treatment of patients with necrotizing soft tissue infections receiving standard of care~     therapy.~   "
83820|NCT02469844|"~     Epilepsy is disabling and costly to patients and the health service. Nearly 400,000 people in~     England suffer from epilepsy. About 40% of these patients are known to have seizures~     predominantly in sleep. All seizures pose risk to the individual both physical and~     psychological. Nocturnal seizures pose extra risk as the diagnosis may be missed or delayed.~     Patients with nocturnal seizures are also thought to be at particular risk of sudden~     unexpected death in epilepsy (SUDEP), especially if their seizures are unobserved. In~     patients with poor seizure control, the risk of SUDEP has been found to be as high as 9 per~     1,000 patient years. Previous studies show that many seizures are associated with changes in~     the Autonomic Nervous System (ANS) tone. The ANS tone can be assessed using heart rate~     variability parameters (HRV). A few studies suggest that ANS tone changes tend to precede the~     onset of epileptic seizure related surface electroencephalographic (EEG) changes, suggesting~     that ANS tone changes could be used in seizure alarm or intervention systems. This~     prospective study intends to focus on seizures from sleep and study HRV parameters in the~     immediate preictal state of the seizure and compare these with resting HRV parameters in the~     same patient with the aim of finding HRV metrics which could help to identify the presence of~     seizures in longterm electrocardiographic (ECG) recordings, or help predict seizure~     occurrence, or provide information about the current risk of seizures. This study will also~     investigate whether there are differences in the alterations of HRV parameters between~     different forms of epilepsy and whether seizure lateralisation has an impact on HRV~     parameters.~   "
83821|NCT02469831|"~     The investigators aim to investigate the differences between deep continuous muscle~     relaxation and moderate blockade during low-pressure (8 mmHg) laparoscopic cholecystectomy in~     respect to metabolic changes and respiratory mechanics.~   "
83822|NCT02469818|"~     Shoulder dislocation is a common clinical presentation in the emergency department,~     comprising about 50 percent of all major joint dislocations. In the standart management of~     shoulder dislocations physicians generally need to see pre and post reduction x ray graphics.~     Ultrasonography is harmless way of evaluating shoulder and may be used in the management of~     the shoulder dislocations instead of the x ray evaluations.~   "
83823|NCT02469805|"~     Four hundred and fifty women with mild male factor infertility will be divided into 3 equal~     groups using computer generated random numbers: Group 1 will have up to 4 stimulated IUI~     cycles, group 2 will have up to 4 unstimulated cycles, women who do not become pregnant after~     the 4 cycles in groups 1 and 2 will be advised to have regular intercourse at the expected~     time of ovulation. Group 3 will be the control group will be advised to have regular sexual~     intercourse at the time of ovulation for 6 months~   "
83824|NCT02469792|"~     Autologous adipose-derived regenerative cells (ADRC) will be extracted using Celution 800/CRS~     System (Cytori Therapeutics Inc) from a portion of the fat harvested from the patient's front~     abdominal wall. Patients will undergo knee arthroscopic surgery followed by one-time~     intraarticular ADRC administration (directly into anterior cruciate ligament). This is a~     single arm study with no control. All patients receive cell therapy.~   "
83825|NCT02469779|"~     The goal of this research study is to learn how middle and high school students react to an~     interactive website called ASPIRE ( A Smoking Prevention Interactive Experience) and health~     information online and what their preferences are when using ASPIRE.~      Researchers hope to use the results of this study to design more effective online health~     programs to provide middle and high school students with up-to-date information about tobacco~     use, meditation, and general health and well-being.~   "
83826|NCT02469766|"~     This study will be conducted to compare the success and complication rates of ureteroscopy,~     and shockwaves lithotripsy for treatment of upper ureteric stones ≤1 cm.~   "
83827|NCT02469753|"~     Ankylosing spondylitis (AS) is a frequent chronic inflammatory rheumatic disease that affects~     the axial skeleton, starting in the sacroiliac joints and spreading to the spine in most~     patients. Non-steroidal anti-inflammatory drugs (NSAIDs) are the primary treatment for AS.~     Even if the use of anti-TNF agents has demonstrated good clinical efficacy in controlling~     inflammation, in contrast to other conditions such as rheumatoid arthritis and psoriatic~     arthritis, anti-TNF treatment has failed to demonstrate any benefit on the structural~     progression of AS, some data even suggesting that it may accelerate the formation of~     syndesmophytes that seems to be an independent process of TNF. Conversely, NSAIDs inhibit~     ossification phenomena independently of their anti-inflammatory properties, owing to a~     specific action on bone formation via prostaglandin inhibition.~      Several features suggest that a continuous NSAID therapy is needed, in addition to anti-TNF~     treatment, to prevent syndesmophyte formation in AS patients.~   "
83828|NCT02469740|"~     Usage of antiplatelet agents and cardiac procedures such as coronary angioplasty has~     dramatically improved the morbidity and mortality associated with coronary artery disease. In~     patients with a coronary stent, dual antiplatelet therapy is recommended. Aspirin is the main~     antiplatelet agent used. For many years, clopidogrel was the second antiplatelet of choice.~     Recent studies have revealed new antiplatelet drugs that can substitute clopidogrel, one of~     which is ticagrelor. The degree to which ticagrelor reduced the overall mortality compared to~     clopidogrel in the PLATO trial suggested that ticagrelor possibly has a pleiotropic effect~     and that the reduction in mortality is not simply due to its antiplatelet effects. The~     ticagrelor molecule resembles adenosine. Adenosine has been shown to be cardioprotective.~      The aim of this project is to study the effects of ticagrelor on the arterial system using a~     noninvasive method. The study will employ the measurement of peripheral endothelial function~     of patients who undergo percutaneous coronary intervention who are on ticagrelor vs.~     clopidogrel using a cross over trial design.~   "
83829|NCT02469727|"~     The Primary Goal is to conduct a 5-10 week randomized controlled trial (RCT) of the Fitbit~     Flex, a popular, affordable, wearable physical activity tracking device, and the Fitbit~     mHealth app. The target population will be childhood cancer survivors 14-18 years old~     recruited from Seattle Children's Hospital. For the intervention group, peer influences will~     be engaged via a private, social network (e.g. a Facebook group) customized for survivors.~     Measurements will be completed (1) at baseline, prior to randomization, and (2) during the~     final week of the intervention period (follow-up measure). This study will provide initial~     proof of concept and allow for further customization of the intervention for childhood cancer~     survivors in anticipation of a future, larger proposal to study physical activity and related~     outcomes over a multi-year period.~   "
83830|NCT02469714|"~     The health care needs of people with serious mental illness are exacerbated by ethnic health~     disparities. Latinos with serious mental illness show significant health problems compared to~     other ethnic groups. Therefore, this project is to develop a meaningful peer-navigator~     program for Latinos with serious mental illness using community-based participatory research~     (CBPR). Investigators are currently working with seven Hispanic/Latinos with a mental illness~     that have formed a Consumer Research Team (CRT) that will guide this project. This project~     will identify and define the problem by conducting a mixed methods research thru qualitative~     interviews with various stakeholders defined by the investigator's CRT group. The qualitative~     findings will then be cross-validated in a quantitative survey by 100 Hispanic/Latinos with~     mental illness. This information will then be used to design an intervention using an~     integrated care model for Peer-Navigators. Feasibility, accessibility , acceptability and~     impact of the peer-navigator program will be then evaluated in a randomized control trial~     (RCT) with 100 Latinos with serious mental illness who will complete measures of physical~     health, mental health, service use and engagement at baseline, 4, 8, and 12 months.~     Investigators expect to show physical health improvement with the greater engagement observed~     in the peer navigator group. Investigators expect a similar improvement in mental health and~     quality of life as physical health concerns are diminished.~   "
83831|NCT02469701|"~     Nivolumab releases the inhibition of the immune system against human cancers. Dramatic and~     sustained activity has been observed in advanced lung cancer. Ablation may stimulate the~     immune system by exposing new tumor antigens. Since tumors that express PD-L1 may be more~     likely to respond to nivolumab, if ablation increases PD-L1 expression (which has not been~     studied) this treatment may enhance the activity of nivolumab at both the treated site and in~     other, non-treated, tumors. Ablation is already an FDA approved treatment for cancer.~     Nivolumab was recently FDA approved for second line treatment of advanced squamous cell~     NSCLC. The goal of the study will be to determine if the combination of nivolumab and~     ablation has higher systemic activity than previously reported with nivolumab alone.~   "
83832|NCT02469688|"~     Examine safety and immunological response for ASP4070 when vaccinated in patients with pollen~     allergy~   "
83833|NCT02469675|"~     Most neurological injuries such as spinal cord injuries (SCI) and amyotrophic lateral~     sclerosis (ALS) spare a portion of nerve circuitry. Strengthening spared nerve circuits may~     be an important method to improve functional recovery.~      In this study, the investigators aim to use non-invasive magnetic and electrical stimulation~     to strengthen motor circuits between the brain and hands. Magnetic stimulation will be used~     over the motor cortex (scalp). Two methods of electrical stimulation will be compared:~     stimulation of the median nerve at the wrist; or direct stimulation of the cervical spinal~     cord across the skin on the back of the neck. Several different combinations of magnetic and~     electrical stimulation will be compared to find the conditions that best strengthen nerve~     circuits between the brain and hands - Fire Together, Wire Together.~      PLEASE NOTE, THIS IS A PRELIMINARY STUDY. This study is testing for temporary changes in~     nerve transmission and hand function. THERE IS NO EXPECTATION OF LONG-TERM BENEFIT FROM THIS~     STUDY. If we see temporary changes in this study, then future studies would focus on how to~     prolong that effect.~   "
83834|NCT02469662|"~     The objectives of the study are to confirm safety and performance of the Zimmer Nexel Total~     Elbow when used in primary or revision total elbow replacement.~   "
83835|NCT02469649|"~     Use of dipole density mapping to identify activation in complex supraventricular~     tachycardias.~   "
83836|NCT02469636|"~     Use of dipole density mapping to identify activation in complex supraventricular tachycardias~   "
83837|NCT02469623|"~     Use of dipole density mapping to identify activation in complex supraventricular~     tachycardias.~   "
83838|NCT02469610|"~     It is well known that chest surgery patients suffer from high level pain in the perioperative~     period. The transition to thoracoscopic approaches reduced surgical pain. The proper pain~     control technique for thoracoscopic approaches is still under debate. One of the most popular~     methods for pain control is these procedures is the Intercostal block. The Intercostal block~     is usually based upon topical analgesic. In this study the investigators will try to examine~     the effect on pain control of the timing of Intercostal block of 100 mg BUPIVACAINE. The~     study is a prospective comparative study. The cohort will be divided into two groups. In the~     control group patients will have Intercostal block after surgery and in the study group the~     intercostal block will be given in the beginning of the surgical procedure. All other~     analgesic treatment during and post-surgery will be the same in both groups. The study will~     evaluate pain level in the days after the surgery, analgesic medication consumption and~     relevant morbidity.~   "
83839|NCT02469597|"~     The purpose of this study is to assess if administration of an early single dose of a~     diuretic (furosemide) to children with moderate to severe bronchiolitis can reduce~     extravascular lung water in an effort to reduce respiratory rate, retractions, intubations,~     and length of stay.~   "
83840|NCT02469584|"~     A descent of the anterior vaginal wall is the most common form of female pelvic organ~     prolapse (POP). Although anterior colporrhaphy (AC) is accepted worldwide as a standard~     procedure, its exact steps are not well standardized.~      We developed a small stitch anterior colporrhaphy (SSTAC) in an effort to increase the~     strength and durability of AC~      Objectives~      The aim of this pilot study is to demonstrate the feasibility and complication rate of the~     SSTAC and to assess the anatomical and functional outcomes after this method of cystocele~     repair.~   "
83842|NCT02469558|"~     Obesity and type 2 diabetes are a pandemic disease leading to a high morbidity and mortality.~     Probiotic modulation of gut flora is a possible therapeutic mechanism.~      The aim of this study is to investigate and compare thoroughly the effect of a multispecies~     probiotic on glycaemic control, gut microbiota and gut permeability in patients with~     metabolic syndrome and diabetes.~   "
83843|NCT02469545|"~     The aim of the study is to determine the influence of supplementation of probiotic~     Lactobacillus Plantarum 299V vs. placebo of probiotic during antidepressant monotherapy with~     SSRI (Selective Serotonin Reuptake Inhibitor) in patients with major depression.~   "
83844|NCT02469532|"~     This is a prospective, multi-center, observational registry to document the baseline, 24-hour~     and 30-day inflammatory response and procedural outcomes out to 12 month follow-up after~     femoropopliteal angioplasty or atherectomy-based revascularization procedures.~   "
83845|NCT02469519|"~     This trial hopes to prospectively evaluate the impact of one versus two courses of antenatal~     steroids on the incidence of major neonatal morbidity in pregnant women with pre-labor~     premature rupture of the membranes.~   "
83846|NCT02469506|"~     Rationale: Situations such as fractures of the lower extremity can necessitate a prolonged~     period of immobilization in otherwise healthy individuals. Long-term immobilization of the~     lower extremity has shown to cause significant reductions in skeletal muscle mass, already~     occurring during the early stages of disuse. Accordingly, feasible strategies for attenuating~     this loss of muscle during disuse need to be pursued. Local neuromuscular electrical~     stimulation (NMES) offers such a potential strategy but, as yet, remains untested during~     prolonged muscle disuse in a clinical setting.~      Objective: To investigate whether twice daily local (gastrocnemius/soleus) NMES attenuates~     muscle loss during 2 weeks of unilateral ankle immobilization.~      Study design: Randomized, parallel (two groups) study design.~      Study population: 30 adults (18-65 y) with any form of closed ankle fractures needing~     surgical treatment.~      Intervention: Twice daily neuromuscular electrical stimulation (NMES) or no intervention.~      Main study parameters/endpoints: Primary: Calf muscle (gastrocnemius) cross sectional area~     (CSA) as determined by CT scan. Secondary: type I and II muscle fiber CSA and SC content,~     intramuscular triglyceride content and mRNA and protein expression of anabolic signaling~     proteins.~   "
83847|NCT02469493|"~     The purpose of this study is to compare the preventive effect of electroacupuncture and sham~     acupuncture on acute chemotherapy-induced nausea and vomiting and then investigate its~     potential mechanism by using functional Magnetic Resonance Imaging (fMRI).~   "
83848|NCT02469480|"~     Iron deficiency has a high prevalence in colorectal cancer patients ranging at ca. 60%. About~     70% of these patients suffer from iron deficiency anemia (IDA) which adds both physical and~     cognitive impediments to an already straining chemotherapy. Moreover, a chronic disease like~     cancer often results in a reduced availability of iron for the body. In clinical practice~     iron substitution is usually administered orally. Due to low resorption rates, frequent~     gastric side effects and thus poor patient compliance a parenteral substitution seems to be a~     better option in terms of efficacy. In the framework of a randomized multicenter clinical~     trial ('FerInject') a comparison of efficacy parameters of parenteral vs. oral iron~     substitution will now be conducted in order to identify the best treatment form for clinical~     practice in oncology. Furthermore detailed quality of life-data (QoL) will be collected in~     both treatment arms for effect comparison.~   "
83849|NCT02469467|"~     The purpose is to evaluate the tolerability, safety and efficacy of VS-505 when given with~     meal for 8 weeks to hemodialysis patients with hyperphosphatemia~   "
83850|NCT02469454|"~     This study aims to assess whether there is change in the growth and development of newborns~     whose mothers will have a etonogestrel (ENG) releasing implant inserted in the first 24 to 48~     hours of delivery compared with those with standard implant insertion (6 week postpartum).~   "
83851|NCT02469441|"~     The aim of the study is to investigate if postoperative coffee intake decreases the time~     until first bowel movement in elective colorectal surgery with primary anastomosis.~   "
83852|NCT02469428|"~     The purpose of this protocol is to assess whether epigenetic factors in healthy individuals~     make a person more or less responsive to lung inflammation following ozone exposures.~   "
83853|NCT02469415|"~     The goal of this clinical research study is to learn if pacritinib, either alone or in~     combination with azacitidine or decitabine, can help to control MDS.~      The safety of this drug and drug combination will also be studied.~   "
83854|NCT02469402|"~     Formula contains significantly higher total protein concentrations than breast milk.~     Therefore formula-fed infants have a significantly higher total protein intake in the first~     few months compared to exclusively breast-fed infants.~      The aim is to examine the nutritive efficacy and safety of a modified infant formula with a~     reduced protein content and improved protein quality in a prospective, double-blind,~     controled, randomized study. Primary outcome measures are weight gain and growth of young~     infants under 12 weeks of dietary intake of the new infant formula. Metabolic effects of the~     qualitative and quantitative changes in the protein content of the new formula will be~     recorded. Two groups of healthy bottle-fed infants will be compared. The treatment group will~     be fed for 3 months with an infant formula with decreased protein content. At the same time~     the protein body of the new formula is modified by enrichment with bovine alpha-lactalbumin.~      A control group receives a isocaloric conventional infant formula and a protein body~     consisting of whey protein and casein in a ratio of 60:40, without specific accumulation of~     alpha-lactalbumin over the same time-period.~      A group of breastmilk fed infants will serve as a reference group. In regular anthropometric~     controls growth and thriving of the study participants is documented and compared between the~     different groups.~   "
83875|NCT02469129|"~     The purpose of this research study is to determine the feasibility of using positron emission~     tomography (PET) imaging technology to image cancer with [18F]FluorThanatrace ([18F]FTT), a~     new radioactive tracer compound that has been developed that images poly(ADP-ribose)~     polymerase 1 (PARP-1) activity.~   "
83888|NCT02468960|"~     Study aim : To compare a novel strategy of lesion preparation with noncompliant balloons~     before implantation of BVS (Bioresorbable Vascular Scaffold).~      Hypothesis: Predilatation with non-compliant balloons could facilitate optimal deployment of~     BVS. By achieving good scaffold apposition a need for post-dilatation could be significantly~     reduced. This is expected to result in better short- and long-term outcomes.~   "
83855|NCT02469389|"~     The goal of this project is to evaluate an innovative psychosocial intervention package that~     will incorporate evidence-based treatment strategies to target the affective-motivational~     deficits, negative expectancies, and behavioral skills deficits that are central to the~     maintenance of negative symptoms. The intervention - called EnCoRE (Engaging in Community~     Roles and Experiences) - will include strategies aimed at teaching Veterans with~     schizophrenia and negative symptoms ways to (1) overcome deficits in anticipatory pleasure,~     (2) increase intrinsic motivation for goal-directed activities, (3) reduce expectancies for~     failure, and (4) perform skillfully in new social situations, all of which can impact~     implementation of new skills and behaviors. Rather than develop a new set of intervention~     strategies, the investigators will include within EnCoRE evidence-based strategies for these~     treatment domains. In addition, the investigators will collect qualitative information both~     from Veterans concerning their perceptions of the strengths, weaknesses, and barriers to~     participation in EnCoRE, as well as from a sample of mental health providers who work with~     Veterans with schizophrenia and negative symptoms, in order to inform a larger scale~     implementation trial should EnCoRE prove effective here.~   "
83856|NCT02469376|"~     Arterial and venous thrombi play an important role in various vascular diseases such as~     myocardial infarction, stroke, transient ischemic attacks (TIA) and pulmonary embolism. These~     thromboembolic disorders are the leading causes of morbidity and mortality worldwide. A~     non-invasive method for the quantitative and effective detection of thrombi in the whole body~     has not yet been established. In spite of the available techniques, 30% to 40% of ischemic~     strokes cryptogenic (undetermined cause, the source of thromboembolism is never~     identified). Possible causes of cryptogenic stroke atherosclerosis include in the aortic arch~     or intracranial arteries. A plaque in the arch or other large vessels could be an important~     source of cryptogenic strokes, however, are those difficult to detect by routine methods. The~     approach of thrombus targeted molecular imaging could identify potentially troublesome~     plaques early on before they become a dangerous rupture. The hypothesis is that the~     radiotracer 18F-arterial GP1 and venous thrombi using positron emission tomography (PET) can~     be made visible. The primary goal is the potential applicability of the substance as a PET~     tracer for diagnosing thrombi.~   "
83857|NCT02469363|"~     During laryngoscopy and endotracheal intubation, stimulation of supraglottic regions leads to~     an increase in the plasma catecholamine concentrations due to the activation of the~     sympatho-adrenal system. Prevention or reduction of this increment is important for~     hemodynamic control. Therefore, various methods such as providing adequate depth of~     anesthesia and shortening the time of laryngoscopy were used. On the other hand; alternative~     laryngoscopy devices and techniques have recently started to be used.~      In this randomized single blind study, the aim is to compare the hemodynamic responses of~     four different laryngoscopy techniques with Macintosh laryngoscope, McCoy laryngoscope, C-Mac~     videolaryngoscope and McGrath videolaryngoscope in patients with normal predictive airway.~   "
83858|NCT02469350|"~     In this study the investigators aim to assess the feasibility and acceptability of a serious~     game to rehabilitate gait and balance disorders in 10 patients with Parkinson's disease~     previously operated for deep brain stimulation of the sub thalamic nucleus.~   "
83859|NCT02469337|"~     The aim of the study is to investigate whether preoperative interventions such as~     carbohydrate drinks, Dichloroacetate and exercise would inhibit or reverse the changes in~     molecular mechanisms regulating muscle carbohydrate oxidation and postoperative muscle~     insulin resistance in patients undergoing major abdominal surgery.~   "
83860|NCT02469324|"~     The current study is a two condition randomized controlled trial for women who are pregnant,~     interested in becoming pregnant, or pregnant within the last year. The conditions include a~     brief Cognitive Behavioral Therapy and a brief Compassionate Mind Training intervention.~     Participants in each condition will complete a 45 minute didactic exercises and readings~     followed by an email with exercises to continue practicing for a total of 2 weeks. After 2~     weeks, participants will receive post-baseline assessment measures (e.g., depression,~     anxiety, affect, self-reassurance, self-attacking, self-criticizing, self-compassion).~     Participants will be recruited through a women's clinic in the United Kingdom by Michelle~     Cree, M.S. and through listservs by Yotam Heineberg, Psy.D. The researchers will also invite~     individuals in their social networks through email and through the Amazon Mechanical Turk~     System.~   "
83861|NCT02469311|"~     Subjects in the study were randomized to a treatment group using Chlorhexidine cloths or a~     standard-of-care group who only had a bath with antibacterial soap and water. Both groups~     received standard infection control practices during admission.~   "
83862|NCT02469298|"~     Study 201682 is a Phase IIa, randomized, double blind, placebo-controlled four arm outpatient~     study evaluating the safety, tolerability and clinical effect of danirixin or danirixin +~     oseltamivir combination in comparison to placebo or oseltamivir twice daily for 5 days in~     otherwise healthy adults with laboratory confirmed influenza infection. Danirixin is a~     selective and reversible C-X-C Chemokine Receptor 2 (CXCR2) antagonist that inhibits~     neutrophil transmigration and activation to areas of inflammation. The study endpoints are~     intended to test the hypothesis that inhibition of neutrophil activation by approximately~     50-60% (as previously measured by cluster of differentiation [CD11b] expression in response~     to chemokine [C-X-C motif] ligand 1 [CXCL1] stimulation ex vivo in human studies) will not~     impact safety parameters or worsen clinical manifestations of disease, disease-related events~     of interest, or viral load, and may possibly improve these parameters when administered~     within 48 hours of symptom onset. The aim of this exploratory study is to obtain data on the~     safety, tolerability and clinical effect of GSK1325756 (danirixin [DNX]) alone or in~     combination with oseltamivir (OSV) in otherwise healthy adults with acute, uncomplicated~     influenza prior to future evaluation in hospitalized patients with complicated influenza. The~     primary objective is to assess safety and tolerability of DNX with and without a~     neuraminidase inhibitor through the evaluation of AEs, SAEs, clinical laboratory tests, vital~     signs, and electrocardiogram (ECG) parameters. Safety assessments will also include an~     assessment of disease related events (DREs) of interest and associated antibiotic use. The~     Influenza Intensity and Impact Questionnaire (FluiiQ™) will be used in the study to document~     patient reported outcomes (PROs). The screening visit in Australia will be composed of a~     pre-screen for influenza infection with an influenza rapid antigen test followed by a screen~     for the remaining eligibility criteria for those subjects with a positive result on the~     influenza rapid antigen test. FluiiQ is trademark owned by Measured Solutions for Health~     Private Limited.~   "
83876|NCT02469116|"~     In this study the investigators will be using an AUC of 6 based on creatinine clearance using~     the Carboplatin dosing formula used for Gynecologic Oncology Group protocols.~      Given that myelosuppression was significant using the docetaxel dose of 75 mg/m*2 in the~     SCOTROC trial, the prophylactic use of pegylated G-CSF in this Phase II trial is warranted.~     The expectation would be that patients will be able to receive their cycles in a more timely~     fashion, with less delays, thereby allowing for improved outcomes and decreased~     hospitalizations due to myelosuppression.~   "
83863|NCT02469285|"~     High consumption of red meat is related to cardiovascular diseases. Red meat containing more~     unsaturated fat than normal red meat may have a beneficial impact on plasma lipid and fatty~     acid profile in humans. Furthermore, consumption of red meat and especially processed red~     meat is considered harmful to colon health. However, consumption of fruit and berries rich in~     antioxidants and flavonoids may provide protection when red meat is consumed.~      The study aims to answer whether the fatty acid profile of pork when modified towards more~     unsaturated fat will affect plasma fatty acids and lipids in adult volunteers. The effects of~     pork with a modified fatty acid content is compared with conventional pork with lower~     unsaturated fat content. Fatty acid composition of pork is modified by altering the~     composition of animal feed.~      The other arm of the study investigates the effects of consuming berries together with red~     meat on gut metabolism. The study focuses on how berries affect the formation of fecal~     compounds known to be related to high red meat consumption, such as N-nitroso compounds.~   "
83864|NCT02469272|"~     Nonalcoholic steatohepatitis (NASH) is common, may progress to cirrhosis and is predicted to~     become a leading indication for liver transplantation in the near future. Though often~     associated with obesity and the metabolic syndrome, our current understanding of disease~     development is limited and there are few therapeutic options. Imbalance of gut bacteria is~     suspected to play a key role driving the progression of fatty liver disease and there is hope~     manipulation of these bacteria may be beneficial. This study will determine if fecal~     microbiota transplantation, using stool from lean donors, is an effective and safe treatment~     for NASH.~   "
83865|NCT02469259|"~     This study will investigate the effects of oxytocin on alcohol-related behaviors, social~     abilities, and physiological startle responses in healthy individuals and patients with~     posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD) using a randomized,~     placebo-controlled, dose-tiered, between-subject study design. Specifically, the~     investigators will determine if intranasal administration of a single dose of the pro-social~     neuropeptide oxytocin decreases alcohol-related approach bias and cravings, enhances social~     abilities, and decreases physiological hyperactivity. The investigators will also determine~     the optimal dose to achieve these effects and will explore psychosocial predictors of~     responses to oxytocin. The proposed work has the potential to yield a novel pharmacological~     treatment for AUD and PTSD, both leading causes of disability in the US Military for which~     currently available treatments are inadequate.~   "
83866|NCT02469246|"~     This study will evaluate the efficacy, safety, and tolerability of switching~     abacavir/lamivudine (ABC/3TC) to emtricitabine/tenofovir alafenamide (F/TAF) versus~     maintaining ABC/3TC in HIV-1 infected adults who are virologically suppressed on regimens~     containing ABC/3TC.~   "
83867|NCT02469233|"~     Mental illness is often severe, chronic and difficult to treat. The sleep disturbance~     commonly experienced by individuals with a severe mental illness reduces capacity to function~     and contributes to key symptoms. This study seeks to determine if an intervention to improve~     sleep can improve functioning and reduce symptoms and impairment. We will conduct this study~     in community mental health centers to ensure that the results contribute to closing the~     worrisome gap between research and practice and to ensure that the findings are generalizable~     to the real world.~   "
83868|NCT02469220|"~     The study examines the effect of a low FODMAP diet in patients with UC in remission but still~     having GI symptoms (IBS in IBD). 15 patients will be on watchful waiting. 15 patients will be~     on low FODMAP diet. 15 patients with recieve FODMAPs in their diet.~   "
83869|NCT02469207|"~     This study aims to use tissue from deceased organ donors to investigate organ physiology,~     developmental biology, as well as the development of future regenerative cellular therapies.~     It will investigate function and immune response to stem cells as well as their generation~     from adult cells and generation of induced pluripotent stem cells (iPSCs).~   "
83870|NCT02469194|"~     In general, the toxicity of radiation therapy and chemotherapy exhibits a strong~     dose-response relationship. However, patients receiving similar doses still exhibit a range~     of toxicity responses due to a variety of factors, including comorbid conditions, disease~     (cancer) specific factors, and inter-individual genetic variation. A very small percentage of~     patients experience side effects that are either extremely severe or extremely mild compared~     to the majority of patients for the dose of radiation or chemotherapy given. Currently, the~     reasons for this are not entirely clear, but likely relate to patient specific factors such~     as immune response, cell/tissue repair capacity and other factors that fundamentally rely on~     rare genetic variations at loci involved in these responses. For example, patients with~     homozygous deletions in DNA damage response genes such as ATM are uniquely sensitive to DNA~     damaging agents. Many patients with severe, homozygous mutations in such genes have other~     sequela that lead to medical recognition of the syndrome prior to therapy. The investigators~     hypothesize that patients with unusually severe toxicity from therapy that do not exhibit~     classical signs of homozygous mutation syndromes are heterozygous for nonfunctional or~     hypofunctional alleles at these loci, such that the defect is only uncovered under the~     relatively acute, severe stress on that pathway by radiation or chemotherapy. Conversely,~     patients with very mild reactions could exhibit rare variants/combinations of variants that~     make them uniquely resistant to chemotherapy or radiotherapy toxicity.~      The purpose of the study is to better understand these mechanisms with the eventual goal of~     developing predictive markers that will allow us to help individually tailor cancer therapy~     is in future patients. Will accomplish these goals by studying a variety of factors from a~     single vial of blood. These will include circulating proteins and hormones, circulating cells~     and the levels and sequences of white blood cell DNA or RNA using a variety of techniques~     including but not limited to determination of cytokine/hormone levels, proteomic analysis,~     immunocytochemical assays, whole exome sequencing and qPCR.~   "
83871|NCT02469181|"~     The purpose of this study is to evaluate the impact of ERT on LV diastolic function and flow~     in patients with Fabry's cardiomyopathy using diastolic stress echocardiography, LV vortex~     flow and CMR.~   "
83872|NCT02469168|"~     The purpose of this investigation is to evaluate the safety, tolerability, preliminary and~     long-term effectiveness of utilizing the ReCell Autologous Cell Harvesting Device (ReCell)~     combined with widened split-thickness skin graft (STSG) mesh onto the dermal regenerate~     INTEGRA™ Meshed Bilayer Wound Matrix (MBWM) for healing of full-thickness wounds.~   "
83873|NCT02469155|"~     The study will evaluate the antipsychotic efficacy of ITI-007 in a randomized, double-blind,~     parallel-group, placebo- and active-controlled, multi-center study in patients diagnosed with~     schizophrenia having an acute exacerbation of psychosis.~   "
83874|NCT02469142|"~     Incarcerated inguinal hernia is one of the common acute abdomen abdominal surgery, often~     prone to intestinal necrosis and acute peritonitis.Using traditional tension hernia~     reparation, the recurrence rate were as high as 30%. In recent years, biological materials~     especially acellular matrix materials (Acellular Dermal Matrix, ADM) in resisting the~     infection, has become a research hotspot. In the project, the investigators try to address~     the role of ADM in incarcerated inguinal hernia patients.~   "
83889|NCT02468947|"~     The investigators want to assess the effectivity of different sample volumes in blood~     cultures.~   "
83879|NCT02469077|"~     Chronic Pain (CP) management has increasingly utilized long-term opioid analgesic therapy, a~     change associated with increased opioid abuse (via greater exposure in vulnerable~     individuals), non-pain health consequences (hormone changes, falls), and a dramatic rise in~     opioid-related overdoses and deaths. Treatment strategies that minimize the need for chronic~     high-dose opioids are sorely needed. This project will test the novel hypothesis that~     effective pain relief can be achieved at lower opioid analgesic doses by increasing levels of~     endogenous opioids (EOs).~   "
83880|NCT02469064|"~     Respiratory muscle training (RMT) is considered a therapeutic strategy to improve respiratory~     muscle strength in mechanically ventilated (MV) patients and facilitates ventilator weaning.~     RMT aims at improving strength and endurance of respiratory muscles . However, scarce~     research exists regarding evaluation of RMT in MV patients and additionally studies differ in~     methods, RMT protocols and subjects included. There are not reports about Colombian studies~     evaluating RMT effects on MV patients. The aim of this study is to evaluate the effectiveness~     of respiratory muscle training in increasing respiratory muscle strength and improving~     weaning outcomes in MV patients who required ventilatory support for more than 48 hours at an~     Intensive Care Unit of an IV level Hospital in Cali during the period 2014-2015~   "
83881|NCT02469051|"~     This study aims at combining inspiration breath-hold myocardial perfusion SPECT with coronary~     CT angiography.~   "
83882|NCT02469038|"~     While peripheral venous cannulation is among the most common procedures performed in clinical~     settings, it is estimated that PIV insertion fails for 6 million patients annually. Failure~     to establish peripheral venous access in the emergency department is a costly problem,~     leading to delays in diagnostics and treatment and requiring alternative sites for vascular~     access. These alternative methods can lead to higher complications rates, decreased patient~     satisfaction, and increased utilization of nursing and physician time. Complications from PIV~     failure also pose a significant financial burden to the healthcare system.~      Ultrasound guidance has been shown to greatly improve the process of localizing vessels for~     cannulation. In a healthcare climate that is increasingly focused on outcomes and~     cost-effectiveness, ultrasound-guided peripheral venous cannulation has become not only a~     viable but often the preferred method in patients with difficult venous access. Nevertheless,~     studies to date on ultrasound-guided peripheral venous cannulation have revealed some~     shortcomings, such as premature failure and low first attempt success rates.~      The purpose of our study is to assess whether ultrasound-guided cannulation of a AccuCath~     catheter, which has a coiled tip guidewire, is superior to ultrasound-guided cannulation of a~     conventional peripheral IV catheter across clinical outcomes relevant to the emergency~     department setting.~   "
83883|NCT02469025|"~     Lower limb osteoarthritis is a major health problem in the westernized countries. The current~     gold standard treatment is joint replacement. However clinical guidelines recommend physical~     therapy as first option for these patients. Manual therapy has reported good reports in~     function, range of motion and pain in patients with hip osteoarthritis. The main aim of this~     study is to test the effects of a manual therapy protocol based on manual traction~     mobilization of the hip joint in an end range position and compare them with the effects~     achieve with the same protocol based on manual traction mobilization of the hip joint in a~     resting position. The investigators will use the caudal traction mobilization described by~     Kaltenborn. The study will test the effects of both treatments in passive range of motion,~     function and pain after three weeks of treatment, three weeks after finalizing the treatment~     and six weeks after.~   "
83884|NCT02469012|"~     The present study evaluates neurocognitive performance as well as measures of mood, quality~     of life, and fatigue in patients with chronic hepatitis C infection. In a prospective~     longitudinal study design, included patients are monitored before, during, and in the~     long-term follow-up of interferon-free antiviral treatment (Sofosbuvir +/-Daclatasvir +/-~     Ribavirin or Sofosbuvir/Ledipasvir +/- Ribavirin). Main study goals are to compare post~     therapy results of sustained virologic responders to corresponding pretreatment values as~     well as to historic interferon-treatment patients without virological response. It is~     expected that HCV-associated neuropsychiatric symptoms and neurocognitive impairment is - at~     least in part - reversible by the successful application of modern IFN-free antiviral~     medication.~   "
83885|NCT02468999|"~     Research in animals and first experiments in humans indicate that insulin action in the brain~     regulates peripheral insulin sensitivity. One major organ might be the liver. Previous~     studies in humans showed that the human brain is an insulin sensitive organ in lean but not~     in overweight/obese persons. Therefore, this study will include lean versus overweight/obese~     persons.~      In this study, insulin action will be introduced by intranasal insulin administration in lean~     and overweight humans. As a control, placebo spray will be administered. To mimick the known~     spill over of small amounts of intranasal insulin into circulation, a small bolus of insulin~     will be administered over 15 minutes following placebo spray application.~      Peripheral insulin sensitivity will be assessed by hyperinsulinemic-euglycemic glucose clamp~     and glucose uptake and endogenous glucose production will be assessed by tracer dilution~     technique. Autonomous nervous system activity will be addressed by heart rate variability.~     Involved brain areas will be addressed by fMRI before and after nasal insulin application.~   "
83886|NCT02468986|"~     Heart disease is the major contributor of early death in rheumatoid arthritis (RA) and is not~     influenced by traditional risk factors. Blood vessel dysfunction has been associated with~     heart disease and complications such as heart attack. The vessel dysfunction is thought to be~     mediated in part to inflammation. RA patients have evidence of vessel dysfunction seen on~     ultrasound that improves after medications are given.~      The purpose of this study is to evaluate patients with controlled or uncontrolled rheumatoid~     arthritis to determine if there is a difference in the protein expression in the cells that~     line the blood vessels compared to healthy people.~   "
83887|NCT02468973|"~     Medical students from zefad medical school volunteer to assist patients with chronic diseases~     to make lifestyle changes.~      Each student will work closely with a family doctor who finds patients who need and want it~     accompanied by a change he introduced them and guide him on health status, medication and~     change the desired objectives.~      In the program students will receive guidance on healthy lifestyle and support a patient to~     perform health changes in theoretical and practical. Training sessions will be held~     periodically, close supervision and guidance, counseling and cross-fertilization and updates~     from the scientific literature.~   "
83890|NCT02468934|"~     The purpose of this study is to determine if electrical stimulation (small levels of~     electricity) can safely and effectively reduce pain following total knee replacement. This~     study involves a device called the SPRINT System. The SPRINT System delivers mild electrical~     stimulation to nerves in the leg that received the knee replacement. The SPRINT System~     includes a small wire (called a lead) that is placed through the skin in the upper leg. It~     also includes a device worn on the body that delivers stimulation (called the SPRINT~     Stimulator).~   "
83891|NCT02468921|"~     The aim of the study is to investigate the influence benign non-toxic goitre and the surgical~     treatment hereof on the voice function before and 6 months following surgery.~   "
83892|NCT02468908|"~     This is a randomized, double-blind, placebo-controlled, single ascending (SAD), and multiple~     ascending dose (MAD) study conducted at a single clinical site within the UK. Healthy male~     and female subjects (on non-child bearing potential) will be enrolled to investigate single~     inhaled doses of molgramostim at 3 dose levels (Part 1) and multiple inhaled doses at 2 dose~     levels (Part 2). The 2 doses in the multiple ascending dose regimens will be administered~     once daily (QD) for 6 consecutive days. The clinical indication for inhaled molgramostim is~     the treatment of respiratory diseases such as aPAP, bronchiectasis and cystic fibrosis. The~     Clinical trial will involve 42 healthy participants. The trial is expected to last~     approximately 4 months.~   "
83893|NCT02468895|"~     Adult patients with suspected or confirmed idiopathic inflammatory myopathy (IIM) will be~     recruited. Patients will be approached, consented, have baseline demographics, diagnostics~     and disease activity measures recorded, and blood taken. The collection of data and~     biological material will mirror usual clinical practice as far as possible. Subjects will~     ideally attend further visits at 3, 6 and 12 months to have bloods taken, outcome measures~     recorded and questionnaires completed.~      In addition, blood, muscle biopsies and imaging undertaken as part of usual care will also be~     collected for research purposes to measure a number of biomarkers for the assessment of~     diagnostic accuracy and clinical utility evaluation. As per usual practice, a muscle biopsy~     will be performed at baseline, and a further biopsy offered at 6 months to assess treatment~     response. A magnetic resonance (MR) muscle protocol will also be performed as per usual~     clinical practice, and a gadolinium-enhanced MR heart scan offered. Both these scans will be~     repeated at 6 months. An existing electronic database entry system will be used for data~     entry and capture on an anonymised basis.~      The study will thus be based around diagnostic evaluations and outcome measures to improve~     quality of care in IIM.~   "
83894|NCT02468882|"~     Population studies associate a higher intake of cruciferous vegetables with a reduced risk of~     cancer. Studies identified PEITC and several active isothiocyanates in watercress extract~     that may have significant anticarcinogenic activity. Potential anticarcinogenic mechanisms~     include: preventing carcinogen activation by inhibiting phase I enzymes such as cytochrome~     P450s, by increasing cells' resistance through detoxification/antioxidant enzymes, by~     inhibiting cell cycle progression and/or by inducing apoptosis.~      These findings are justifiably interesting for the primary care setting and cancer primary~     prevention. Yet, these cellular effects of watercress supplementation may further prove~     useful in the modulation of cancer progression and disease recurrence. The present clinical~     trial of nutritional supplementation in cancer, intends to further explore the effects of~     therapeutic diets supplemented with nutraceuticals via watercress that may prove useful in~     DNA damage modulation, as well as in the global disease prognosis.~   "
83895|NCT02468869|"~     The goal of the proposed study is to assess the potential of information structuring for~     improving discharge communication. Specifically, the investigators aim to examine the~     advantages of an information-structuring skills training for physicians (compared to an~     empathy skills training) on discharge communication and associated patient outcomes, such as~     patients' information recall and adherence to physician recommendations. The investigators~     hypothesize that patients receiving structured discharge information from their trained~     physicians will be able to recall more information and show higher adherence to~     recommendations relative to controls (i.e., patients receiving discharge information from~     doctors trained in empathy skills).~   "
83896|NCT02468856|"~     Sleep deprivation slows reaction time, reduces vigilance and impairs judgment and information~     processing. Chronic effects include metabolic dysfunction, cardiovascular disease and cancer.~     Sleep deprivation affects quality of life when it causes errors in judgment, whether these~     occur behind the wheel of an automobile or in a hospital. Armodafinil, a non-amphetamine~     wakefulness promoting medication, indicated for excessive sleepiness associated with~     obstructive sleep apnea, narcolepsy, and shift work sleep disorder is used to mitigate the~     effects of sleep deprivation.~      This study will characterize the effect of armodafinil on driving simulator performance. The~     effects of armodafinil compared to placebo will be studied in a double blind crossover trial~     involving 10 healthy subjects with serial assessments at baseline and after extensive sleep~     deprivation. Using simultaneous electroencephalogram (EEG) recording during simulated driving~     and neurocognitive assessments of vigilance, the relationship between brain activity and~     cognitive performance will be established.~   "
83897|NCT02468843|"~     Deep brain stimulation (DBS) is an effective surgical therapy for select Dystonia patients~     who are refractory to medications or who have generalized symptoms (e.g. patients with~     Early-Onset Primary Dystonia(DYT1) mutations and other dystonia subtypes). DBS patients~     typically experience significant improvement in disabling symptoms; however, detailed~     programming is always required, and stimulation-induced side effects commonly emerge.~     Clinicians may empirically vary voltage, pulse width, frequency and also the active contacts~     on the DBS lead to achieve observed optimal benefits.~      The majority of DBS patients undergo repeat surgeries to replace the implantable pulse~     generator (IPG) every 2.5 to 5 years. It has been demonstrated that, in dystonia patients,~     that higher settings are required for adequate symptomatic control, and that neurostimulators~     have a considerably shorter life when compared to neurostimulators from patients with~     essential tremor or Parkinson's disease. Additionally, several smaller studies have suggested~     that alternative pulse stimulation properties and pulse shape modifications can lower IPG~     battery consumption.~      Newer patterns of stimulation (regularity of pulses and shapes of pulses) have not been~     widely tested in clinical practice, and are not part of the current FDA device labeling.~     Novel patterns of stimulation do however, have the potential to improve symptoms, reduce side~     effects, and to preserve the neurostimulator life.~      The current research proposal will prospectively study biphasic pulse stimulation paradigms~     and its effects on dystonic symptoms. The investigators aim to demonstrate that we can tailor~     DBS settings to address dystonia symptoms, improve the safety profile, characterize distinct~     clinical advantages, and carefully document the safety and neurostimulator battery~     consumption profile for biphasic stimulation.~   "
83898|NCT02468830|"~     The objective is to evaluate the efficacy and safety of mirabegron to treat urinary~     incontinence in children with Overactive Bladder that are refractory and/or intolerant to~     antimuscarinics.~   "
83901|NCT02468791|"~     The purpose of this study is to evaluate biosimilarity between test product MabionCD20® and~     the reference product - MabThera® (rituximab) and to demonstrate comparative safety and~     tolerability of a single course of treatment of MabionCD20® and MabThera® in patients with~     moderate to severe active rheumatoid arthritis.~   "
83902|NCT02468778|"~     The HeartMate PHP System is a temporary (<6 hours) ventricular assist device indicated for~     use during high risk percutaneous coronary interventions (PCI) performed in elective or~     urgent, hemodynamically stable patients with severe coronary artery disease and depressed~     left ventricular ejection fraction.~   "
83903|NCT02468765|"~     Cognitive and emotional disorders are often encountered in multiple sclerosis (MS) cases:~     depressive and bipolar disorders are twice as frequent as in general population.~      Cognitive disorders, (particularly attention and dysexecutive disorders), appear in early~     stages of the disease's evolution, in cases of lightly or moderately disabled patients, with~     a recent evolution, with a minor form of the disease, even in Clinically Isolated Syndromes~     (CIS). Emotional disturbances are essentially linked to mood disorders of depression-type.~      Last ten years, emotional processing in multiple sclerosis cases was investigated in various~     trials, especially regarding the recognition of facial and emotional expressions. These~     studies reported data, supporting an impairment of the perception of emotion, particularly~     those with negative valence.~      The objective of this study is to investigate the link between recognition of facial and~     emotional expressions and depression in multiple sclerosis cases.~   "
83904|NCT02468752|"~     Primary objective:~      - Assessment of venous gas emboli load post diving when breathing normobaric oxygen compared~     to air.~      Secondary objectives:~        -  Assessment of flammatory activity in blood post diving~        -  Assessment of fluid markers of central nervous system injury in blood post diving~        -  Assessment of DCS frequency~        -  Comparison of TCD and TTD consistency in venous gas emboli measurements~   "
83905|NCT02468739|"~     Monosialotetrahexosyl ganglioside (GM1) protect breast cancer patient from taxanes-related~     neurotoxicity.~   "
83906|NCT02468726|"~     In order for flexible sigmoidoscopy to be a successful screening procedure, the bowel must be~     free of solid matter so the endoscopist has a clear view, increasing the chance of detection~     of abnormalities. This is achieved through the use of bowel cleansing preparations, which are~     administered prior to the procedure. Enemas are the preferred method as they clear the lower~     bowel more quickly than oral formulations and do not require dietary restrictions.~      The medical device being tested in this clinical investigation is NER1008, an enema which~     contains PEG3350 (polyethylene glycol 3350). PEG3350 is an osmotic agent, which holds the~     water content in the rectum and sigmoid colon, consequently increasing stool volume,~     resulting in rectal distension and subsequent distal colon emptying. The increased colonic~     luminal content stimulates the motility, propulsive transportation and rectal evacuation of~     the distal colon content.~      This study is designed to assess the performance of NER1008 in bowel cleansing and compare~     this with the performance of Fleet® enema, which is widely used for this purpose.~   "
83907|NCT02468713|"~     Fish oil is a rich source of omega-3 fatty acids, especially eicosapentanoic acid and~     docosahexaenoic acid, and it is not used widely in parenteral nutrition because fish oil~     emulsions have not been commercially available until very recently. The Objective of this~     study is to to evaluate the effect on blood lipid profiles of omega-3 enriched total~     parenteral nutrition in healthy Korean male subjects. This study is designed as a randomized,~     open-label, 2-treatment, 2-way crossover trial. Blood samples will be collected every 1 hour~     from 0 to 12 hours after starting an intravenous infusion for triglyceride, glucose, and~     insulin.~   "
83908|NCT02468700|"~     The objective of the study was to evaluate the efficacy and safety of OTX-DP (dexamethasone~     insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the~     treatment of the signs and symptoms of dry eye disease~   "
83909|NCT02468687|"~     The study will evaluate if the N-methyl-pyrrolidone (NMP) can be safely administered to~     humans at doses, which induce measurable immunological and anti-tumour effects in patients~     with myeloma who are resistant to or intolerant of lenalidomide and bortezomib.~   "
83910|NCT02468674|"~     A 24-week off drug extension parallel group study assessing the durability of effect on~     skeletal muscle strength and function following a 6-month double-blind placebo-controlled~     study evaluating bimagrumab in older adults with sarcopenia~   "
83911|NCT02468661|"~     The purpose of this study is to determine the maximum tolerated dose (MTD) or recommended~     phase II dose (RP2D) of INC280 in combination with erlotinib in the Phase Ib of this study,~     and to assess the anti-tumor activity and safety of INC280 alone, and in combination with~     erlotinib, versus platinum with pemetrexed in the Phase II of this study, in adult patients~     with EGFR mutated, cMET amplified, advanced/metastatic non-small cell lung cancer with~     acquired resistance to prior EGFR TKI.~   "
83912|NCT02468648|"~     Background:~      - Chronic hepatitis C is a serious liver disease. Current treatments have side effects. New~     drugs have been developed, but they work better in some people than others. Researchers want~     to learn why.~      Objective:~      - To learn why new hepatitis C drugs sometimes don t work. Also, to learn if these drugs are~     safe and how well they work in people with different virus strains.~      Eligibility:~      - Adults age 18 and older who are infected with hepatitis C virus genotypes 1-4 and who have~     either never been treated or treated previously with an interferon regimen (with or without~     ribavirin) that failed to clear the virus.~      Design:~        -  Participants will be screened with medical history and physical exam. They will have~          blood and urine tests and complete questionnaires.~        -  Participants will have a Fibroscan an ultrasound that measures liver stiffness and other~          liver scans. They will have an electrocardiogram.~        -  Eligible participants will have a liver biopsy.~        -  Participants will be admitted to the Clinical Center. They will have a physical exam and~          blood tests, and complete questionnaires.~        -  They will take the first study drug dose as a tablet taken once daily.~        -  Participants will take the drug at home for 12 weeks.~        -  Participants will have 6 study visits. They will have blood and vital signs taken, and~          complete questionnaires.~        -  At week 4, participants will have another liver biopsy.~        -  After their last drug dose, participants will have 5 follow-up visits. They will have~          blood and vital signs taken, and complete questionnaires. They will discuss their~          medications and side effects. They may have another Fibroscan.~   "
83913|NCT02468635|"~     Chronic obstructive pulmonary disease (COPD) is characterized by the obstruction is not fully~     reversible airway, where the severity of the disease and the prognosis is not determined~     solely by changes in lung function. Pulmonary rehabilitation is a multidisciplinary program~     of care for patients with chronic respiratory diseases, individually designed to optimize~     physical and social performance and autonomy of these patients, promoting improvement in~     functional exercise capacity, quality of life, reducing dyspnea, frequency and duration of~     hospitalizations and reduce the frequency of exacerbations of the disease. The overall~     objective of the research is to evaluate the effects of pulmonary rehabilitation program on~     exercise capacity, lung function, quality of daily life and reduction of dyspnea in patients~     with COPD. A study type randomized, open-label trial following the recommendations of the~     CONSORT (Consolidated Standards of Reporting Trials) will be held. The study will be~     conducted at the Clinic Physiotherapy Course of the School with a sample of 58 patients. The~     intervention will be performed sessions three times a week for 16 weeks (8 weeks for~     assessment and 8 weeks for adaptation and (pulmonary rehabilitation training). The PR~     (pulmonary rehabilitation) will last 60-120 minutes each.O group A (control) will receive~     treatment of traditional pulmonary rehabilitation and without resistive training for upper~     limb (UL) and group B will receive the same treatment control with additional training of~     upper limb strength.~   "
83914|NCT02468622|"~     Despite the fact that migraine is a common disorder, the pathogenesis is still not fully~     elucidated. Studying transcriptomic and biochemical changes during induced and spontaneous~     migraine-attacks will enhance our understanding and may point to new targets for drug~     development.~   "
83915|NCT02468609|"~     To investigate the diagnostic value of ultralow-dose computed tomography in the detection of~     pulmonary nodules and lung parenchym alterations (e.g. emphysema) compared to~     standard-dose-CT.~   "
83916|NCT02468596|"~     The QTRAC method is an electrophysiological technique that assesses peripheral nerve axonal~     excitability, using computerized analysis of the muscular response of musculus abductor~     pollicis brevis, to series of electrical stimulations of the median nerve.~      Because of its high sensitivity to small changes in axonal excitability, QTRAC may help~     improve the follow-up of patients suffering from peripheral neuropathy caused by~     anti-myelin-associated-glycoprotein antibodies (anti-MAG neuropathy), as axonal excitability~     is early affected in this disease.~      The main aim of the study is to compare QTRAC results in anti-MAG neuropathy patients, with~     QTRAC results in healthy persons (matched for sex and age).~      A secondary aim is to determine whether or not the disease's clinical severity (measured by~     quantitative clinical scores) is correlated with the results of the QTRAC and could be~     predicted by a model based on the several parameters measured in the QTRAC exploration.~      100 anti-MAG neuropathy patients will undergo a QTRAC exploration and a thorough neurological~     examination with clinical scoring. The results will be compared with data (matched by sex and~     age) from the reference database on healthy subjects, that is provided with the QTRAC~     software.~      The investigators expect to prove that QTRAC results are modified in anti-MAG neuropathy~     patients, and that the clinical severity of the disease can be predicted by a combination of~     QTRAC-measured parameters.~   "
83917|NCT02468583|"~     This study was a double-blind, randomized, parallel group, proof of concept study comparing~     FX006 to Kenalog®-40 (triamcinolone acetonide injectable suspension, USP) in patients with~     post-traumatic osteoarthritis of the knee.~   "
83918|NCT02468570|"~     Phase 3 substudy enrolling approximately 100 subjects, aged ≥ 18 to ≤ 70 years old, with PKU~     who are concurrently participating in the 165-302 study.~   "
83919|NCT02468557|"~     This study will evaluate the safety, pharmacodynamics, pharmacokinetics (PK), and efficacy of~     single agent idelalisib and in combination with chemotherapy in adults with metastatic~     pancreatic ductal adenocarcinoma. This study will also define the the maximum tolerated dose~     (MTD) of idelalisib in combination with chemotherapy.~   "
83920|NCT02468544|"~     This is an open-trial pilot study in which adult methadone maintenance treatment patients who~     are living with HIV but are not engaged in HIV primary care (i.e., missed appointments,~     non-adherence to medication) will be recruited to participate in a HIV primary care~     engagement study. The purpose of this study is to develop and test the feasibility and~     acceptability of a mobile phone-based health (mHealth) text messaging intervention to improve~     engagement in HIV primary care among substance abusing populations with HIV.~   "
83921|NCT02468531|"~     Acute lung injury (ALI) is the vital complication of Stanford type A aortic dissection. It is~     confirmed that Xenon has the significant protective effect on important organs and has no~     suppression on the cardiovascular system. Furthermore, our earlier trial has already~     clarified that static inflation with 50% Xenon during cardiopulmonary bypass could attenuate~     ALI for Standford A acute aortic dissection. However the protection effect was restricted for~     the limited time. Aimed to enhance the protection effect of Xenon, we designed this~     randomized trial that anesthesia with 50% xenon one hour before and after CPB and pulmonary~     static Inflation with 50%,75% and 100% Xenon during CPB respectively.~   "
83922|NCT02468518|"~     This study will be conducted to observe any change in aerobic bacterial pattern on the skin~     of arsenicosis patients before and after administration of vitamin E (200 IU) capsules.~   "
83923|NCT02468505|"~     Young adults who have Autism Spectrum Disorder (ASD) without co-occurring intellectual~     impairment face a fairly unique set of challenges as they transition out of secondary school.~     These students are often quite capable of succeeding in higher education and many of them~     have interest in pursuing advanced degrees, but the nature of their disability and associated~     deficits (e.g., poor time management and poor self-regulation) may impede success.~     Individualized, appropriately timed, and developmentally sensitive transition and support~     services may promote optimal outcomes for these young people. The goal of this project is to~     develop a comprehensive program to promote successful transition of students with ASD from~     high school to post-secondary education.~   "
83924|NCT02468492|"~     The purpose of this study is to evaluate the affect that platelet rich plasma has on the~     molecular an cellular functioning of the knee joint.~   "
83925|NCT02468479|"~     Chest/abdominal wall varices and spider nevi are two common presenting signs of liver~     cirrhosis. Their prognostic values remain unclear.~   "
83926|NCT02468466|"~     The purpose of this study is to examine the effectiveness of a community-based~     depression-screening program for suicide prevention among middle-aged adults, the~     investigators conducted a quasi-experimental intervention study, using a parallel cluster~     design with communities at municipal level as the unit of allocation and individuals as the~     unit of analysis.~   "
83927|NCT02468453|"~     This is a multi-center, multi-cohort, prospective, open-label study of VELOS for treatment of~     vascular skin disorders. The plan is to enroll up to 60 subjects from up to 3 centers in the~     US and worldwide. The purpose is to collect data from the use of VELOS.~   "
83928|NCT02468440|"~     Treatment care of end-stage renal insufficiency is an important public health issue. The~     balance between patients waiting for a kidney transplant and available graft raises~     questions. Because of the non-adherence, risk of graft loss is increased to 7 times so in~     this trial patients will experiment an educational therapy's program as soon as they register~     on the transplant list.~   "
83929|NCT02468427|"~     In a prospective, randomized Trial, the investigators compare Hands-on teaching and frontal~     teaching using a Training Video for learning how to perform an assisted delivery by vacuum~     extraction on a pelvic Training model. Objective Structured Assessment of Technical Skills~     (OSATS) scores are the primary outcome. The investigators hypothesize that Hands-on Training~     is superior to a video-teaching with regard to the OSATS scores achieved by the Trainees.~   "
83930|NCT02468414|"~     The objectives of this study are to assess safety and to evaluate the biologic activity of~     TARGTEPO treatment in Peritoneal Dialysis patients~   "
83931|NCT02468401|"~     There is a pressing need to find effective strategies for the prevention of contrast induced~     nephropathy in patients with advanced renal dysfunction. The current study was designed to~     assess the efficacy of a new protocol for preventing contrast induced nephropathy in patients~     with advanced renal dysfunction undergoing coronary interventions~   "
83932|NCT02468388|"~     The purpose of this study is to evaluate the clinical effect of chewing gum containing~     maltitol, on re-mineralization of early caries following daily chewing for 6 months by school~     children, compared to a xylitol gum, gum base and a no gum group.~   "
83933|NCT02468375|"~     The purpose of this study is to measure the treatment satisfaction after switching to~     mirabegron in patient with Overactive Bladder(OAB) who were unsatisfied with efficacy of~     antimuscarinic therapy or adverse event.~      Patient will take the mirabegron 50mg/day for 12 weeks, and the satisfation of the therapy~     will be measured with Treatment Satisfaction Questionnaire(TSQ), Global Response~     Assessment(GRA), OAB-q short form, OAB Symptom Score and Willingness to continue Questions.~   "
83934|NCT02468362|"~     Through a double blinded study, patients with low rectal cancer will be randomized into two~     equal groups to compare between the 5 year disease free survival as a primary outcome~     measure.~   "
83935|NCT02468349|"~     The proposed research aims to compare Left ventricular remodeling outcomes among patients~     with AMI and elevated NT-pro-B-type natriuretic peptide receiving telemedicine-guided post-MI~     treatment vs. non-telemedicine guided treatment.~   "
83936|NCT02468336|"~     The objective of this study is to demonstrate that the investigational device, AngioDefender,~     is comparable to the established procedure referred to as 'brachial artery ultrasound~     imaging' in their abilities to quantify flow-mediated vasodilation of the brachial artery.~   "
83937|NCT02468323|"~     This study aims to compare the quality of perioperative antiemesis of palonosetron and~     ondansetron in patients undergoing cesarean section~   "
83938|NCT02468310|"~     Introduction Maternal and neonatal mortality continue to be to be prominent public health~     issues in sub Saharan Africa including Ghana, with slow progress made towards attainment of~     Millennium Development Goals (MDG) 4 & 5. Studies have identified poor quality of maternal~     and child healthcare as a major challenge to the prevention of neonatal and maternal deaths.~     Effective interventions are required to make significant inroads in these areas.~      Objective To evaluate the effect of a SMS text messaging intervention to support clinical~     decision making by frontline health care professionals on neonatal and maternal mortality.~      Methods We propose to conduct a randomized controlled trial in the Eastern region of Ghana,~     involving 8 intervention and 8 control districts. The intervention consists of text messaging~     of standard protocols for maternal and neonatal care to front line health care providers in~     the region. A total of 17,040 pregnant women who are receiving care (including antenatal,~     delivery and post-natal) at any of the hospitals in the selected districts in the region will~     be monitored through monthly aggregate data on outcome measures such as neonatal and maternal~     deaths from eclampsia, postpartum haemorrhage, puerperal sepsis, birth asphyxia, low birth~     weight and neonatal sepsis. Cord sepsis will also be included as neonatal sepsis for this~     study. Also, a quality of care assessment in four sampled districts to measure adherence to~     the safe motherhood protocol will be conducted. Stata software package.55 and MLwiN software~     version 2.2456 will be employed in data analysis. Descriptive analysis will be carried out to~     explore baseline characteristics of study groups while logistic regression will be applied to~     evaluate the effect of the intervention. A two-tailed statistical significant level of 0.05~     will be used.~      Expected outcome We hypothesize that the intervention will improve both maternal and neonatal~     service delivery and health outcomes in the intervention areas.~   "
83939|NCT02468297|"~     This randomized , double-blind, parallel-arm clinical trial was designed to study the~     efficacy and safety of the Electronic Acupuncture Shoes treatment on chronic low back pain~     patients.~      Chronic low back pain patients, aged 20-60, of both gender were recruited. As the primary~     outcome measure to assess the efficacy, 0-10 numerical rating scale was used. Secondary~     outcome measure included the speed of pain-relief.~      The number of samples in the experimental group and the control group ratio of 1 : 1 , is~     expected to total effective sample number is 60 . Experimental group will receive a six-week~     Electronic Acupuncture Shoes treatment and a week back to the clinic three times , subject~     to a total of 18 treatments , each course of about one hour . Subjects will take NSAID~     placebo in the first week of the course of treatment . After the second week of NSAID placebo~     on disabled.~      Control subjects will also accept the six- week treatment , control subjects will be equally~     back to the clinic three times a week , each group will be given to the subject of one hour~     each shoe pseudo electrotherapy treatment group and control group run by entering from the~     test day in the first week of the course , each taking ibuprofen 400mg, taken three times a~     day , the second week after the NSAID drugs on disabled.~   "
83940|NCT02468284|"~     The purpose of this trial is to look at how much a new trial drug get into body, such as when~     the drug concentration in your body reaches peak and how high the peak value is.~   "
84014|NCT02467322|"~     All consecutive patients admitted in ILBS from MAY 2015 to DECEMBER 2016. Decompensated~     cirrhosis patients will be randomized into Group 1: MVP (Moderate Volume Paracentesis) of~     less than 5 litres with iv albumin at a dose 8 gms/l of ascitic fluid Group 1: MVP (Moderate~     Volume Paracentesis) of less than 5 litres without albumin .~   "
83941|NCT02468271|"~     There is an increasing demand for researchers and regulatory bodies to use robust outcome~     measures in clinical trials which have evidence of validity, reliability, and responsiveness.~     There is currently little agreement on the core clinical endpoints that should be used in~     bronchiectasis. The importance of improving endpoint outcome measurement is well recognised~     and groups in other conditions have focused on activities to achieve consensus on a core set~     of outcomes for clinical trials. The Bronch-UK collaboration has explored the current~     evidence for clinimetric properties of commonly used outcome measures in bronchiectasis (e.g.~     forced expiratory volume in one second [FEV1], health related quality of life [HRQoL], and~     pulmonary exacerbations). The results of this extensive rigorous literature review of 68~     papers clearly demonstrate that whilst there was good evidence for validity for key outcome~     measures in bronchiectasis there is little information available on their reliability (during~     periods of clinical stability) or response to treatment (effect sizes).~      The aim of this study is to explore the clinimetric properties of a range of outcome~     measures, in order to make recommendations for their use in clinical trials in~     bronchiectasis.~   "
83942|NCT02468258|"~     Patients & Methods: Eighty infertile women were randomly categorized into: Group EF (n=40)~     had EF after oocyte retrieval and Control group (n=40) did not have EF. All women were~     subjecte to the standard down-regulation regimen followed by controlled ovarian hyper~     stimulation . Oocytes were retrieved 34-36 h after hCG administration and aspirated FF was~     collected and centrifuged at 600 rpm for 10 min and 5-ml sample of supernatant was obtained~     for ELISA estimation of tumor necrosis factor-α (TNF-α), granulocyte colony-stimulating~     factor (G-CSF), leptin and anti-Mullerian Hormone (AMH) levels in both groups. The remaining~     amount was used for EF in EF group and was discarded in control group. Pregnancy was~     diagnosed by measurement of β-HCG level and confirmed by transvaginal sonography as clinical~     pregnancy~   "
83943|NCT02468245|"~     This study is being conducted by Bassett Healthcare Network in coordination with Bassett~     Cancer Institute. Patients prescribed oral chemotherapies will be approached to consider~     consent to this study. This study will try to establish if nursing interventions can help~     improve patients' adherence to taking their oral chemotherapies as prescribed by their~     doctor. Oral chemotherapies are emerging as a growing treatment of choice for many cancer~     diagnoses. Adherence to the prescribed treatment plan is very important to gain the best~     response to these types of treatments. The study will examine if nursing intervention via~     weekly phone calls may help improve adherence to oral chemotherapy treatment plans.~   "
83944|NCT02468232|"~     The purpose of this study is to assess the effect of LCZ696 at a target dose of 200 mg b.i.d.~     compared to enalapril 10 mg b.i.d., in addition to the background heart failure (HF)~     treatment, on delaying time to first occurrence of either cardiovascular (CV) death or HF~     hospitalization events in Japanese patients with stable chronic heart failure (CHF), New York~     Heart Association (NYHA) classes II-IV and reduced ejection fraction (left ventricular~     ejection fraction (LVEF) ≤ 35%).~   "
83945|NCT02468219|"~     This study will evaluate hemodynamic and functional changes resulting from valve intervention~     in patients with severe aortic stenosis undergoing valve replacement (AVR) or transcatheter~     aortic valve implantation (TAVI), and their influence on the pathophysiological mechanisms~     involved in cardiovascular rehabilitation.~   "
83946|NCT02468206|"~     The purpose of this study is to study the efficacy of endoscopic cyanoacrylate injection~     versus balloon-occluded retrograde transvenous obliteration in the prevention of gastric~     variceal rebleeding and improvement in survival.~   "
83947|NCT02468193|"~     The study aim is to investigate the efficacy and safety of Osilodrostat in patients with~     Cushing's syndrome due to causes other than Cushing's disease in Japan.~   "
83948|NCT02468180|"~     The purpose of this study is to study the efficacy of endoscopic cyanoacrylate injection~     versus balloon-occluded retrograde transvenous obliteration in the prevention of gastric~     variceal bleeding.~   "
83949|NCT02468167|"~     The purpose of this study is to study the efficacy of endoscopic cyanoacrylate injection~     versus balloon-occluded retrograde transvenous obliteration in the management of acute~     gastric bleeding.~   "
83950|NCT02468154|"~     Assess whether by placing a custom made splint with heel in the immediate postoperative~     period until removal of the cast, the rate of pain, the number of healthcare interventions to~     maintain the off-loaded heel position and number of pressure sores in children wearing lower~     limb plaster casts is reduced.~   "
83951|NCT02468141|"~     To determine efficacy and safety of Sipjeondaebo-tang for Cancer patients suffering from~     anorexia after chemotherapy. Sipjeondaebo-tang will be administered for 4 weeks, 3 times per~     day after a meal. Changes of FAACT scale, Anorexia VAS, Weight, BMI, Clinical laboratory test~     such as ACTH, Cortisol, Chrelin, IL-6, ESR, CRP will be measured and analyzed.~   "
83952|NCT02468128|"~     This is a randomized, double blind, placebo-controlled, single dose study to assess the~     safety, efficacy and pharmacokinetics of intramuscular sebacoyl dinalbuphine ester (SDE) for~     post-hemorrhoidectomy pain management.~   "
83953|NCT02468115|"~     A phase 2 a study to assess the safety profile and the effect of VIS410 in healthy subjects~     after inoculation with influenza A virus (H1N1).~   "
83954|NCT02468102|"~     This prospective cohort study will provide information about:~      Characteristics of Rivaroxaban use in patients who are prescribed Rivaroxaban for the first~     time compared to patients who are prescribed standard of care for the first time.~      The occurrence of intracranial haemorrhage, gastrointestinal and urogenital bleeding, and the~     occurrence of non-infective liver disease.~   "
83955|NCT02468089|"~     A Minimum of 150 consecutive patients of decompensated cirrhosis of any etiology, presenting~     to the Institute of Liver and Biliary Sciences hospital with a diagnosis of difficult to~     treat SBP will be included and randomized into two treatment groups.~      Group A - Carbepenem+albumin Group B - Carbepenem+albumin+GMCSF.~   "
83956|NCT02468076|"~     This phase-2 study aims to evaluate feasibility, safety and efficacy of thermal ablation of~     biliary obstructive malignancies by means of radiofrequency ablation (RFA, ELRA, StarMed)~     during endoscopic retrograde cholangio-pancreaticography (ERCP) with primary intent to obtain~     palliative biliary drainage via stenting~   "
84015|NCT02467309|"~     The purpose of this study is to determine whether deficiency of Vitamin D has association~     with outcomes of children with bacterial meningitis.~   "
83957|NCT02468063|"~     The consecutive patients admitted to Intensive care unit of Hepatology department of ILBS and~     full filling all the eligibility criteria will be enrolled in 1:1 ration by the process of~     randomization.- The study is an open level study. The investigators will strictly follow the~     randomization table to give therapy as per the intervention arm.~        -  Intervention:-the therapeutic intervention is vasopressor i.e. noradrenaline alone and~          terlipressin along with noradrenaline to maintain the MAP >65mm Hg.~        -  Intervention arm~             -  Arm (A) - Noradrenaline~             -  Arm (B) - Noradrenaline + low dose terlipressin~   "
83958|NCT02468050|"~     The breast cancer screening and diagnostic period is associated with heightened symptoms of~     anxiety and depression. Physical exercise has been found to effectively decrease these~     symptoms in healthy and diseased populations. This study aims to determine if a pre treatment~     exercise intervention can minimize symptoms of anxiety and depression in women undergoing~     screening for breast cancer.~   "
83959|NCT02468037|"~     High tissue iron is a risk factor for diabetes even within the broad normal range of normal~     human values. In order to demonstrate the benefits of reducing iron on glucose homeostasis~     and to better define the parameters for larger clinical trials, the investigators will~     subject individuals with prediabetes (impaired glucose tolerance, IGT) or early type 2~     diabetes to phlebotomy in order to reduce serum ferritin concentrations and determine the~     effect on glucose homeostasis as revealed by oral and frequently sampled intravenous glucose~     tolerance testing.~   "
83960|NCT02468024|"~     To Determine if SAbR improves survival over SR in High Risk Operable Stage I NSCLC~   "
83961|NCT02468011|"~     Previous studies reported that myoelectrical activity increased during whole body vibration~     (WBV). The investigators hypothesized that the change in soleus muscle length does not affect~     the whole body vibration induced soleus reflex muscle activity but the change in ankle angle~     affects the whole body induced soleus reflex muscle activity. The purpose of this study is to~     test this hypothesis.~   "
83962|NCT02467998|"~     The goal of the Negative Pressure Wound Therapy Registry (NPWTR) for Wounds is to provide~     real world patient data from electronic health records submitted to meet Stage 2 Meaningful~     Use in order to understand the effectiveness and safety of various NPWT devices and methods~     among patients with chronic wounds and ulcers. Randomized, controlled trials to establish~     product efficacy routinely exclude patients with the co-morbid conditions common to patients~     seen in usual clinical practice and thus the results of these Randomized Controlled Trials~     (RCTs) tend to be non-generalizable. Little is known about the effectiveness of NPWT among~     typical patients. Patient registries are also ideal for assessing long term safety issues in~     these devices.~   "
83963|NCT02467985|"~     Patients undergoing laparoscopic surgery suffer in 30-85% of cases of referred pain in the~     shoulder in the first days following their intervention. Pain can be disabling and may even~     delay the discharge of patients. Several techniques have been proposed to reduce this~     problem. Promising strategies include the reduction of CO2 insufflation flow, lung~     recruitment maneuvers and active aspiration of intraperitoneal air at the end of surgical~     procedure to force gas discharge. The investigators wish to perform a randomized controlled~     trial with 160 women, who will assess the effect of a combined approach, combining for the~     first time lung recruitment maneuvers and aspiration of pneumoperitoneum in the Trendelenburg~     position at the end of surgery and flow of insufflation reduces carbon dioxide (CO2) forming~     the pneumoperitoneum during surgery, on the intensity of shoulder pain postoperatively. In~     the control group the evacuation of the pneumoperitoneum will be done by opening the trocars~     and external abdominal pressure at the end of surgery. No study to our knowledge has tested~     the active aspiration maneuvers gas after laparoscopic surgery in gynecology. The study will~     be preceded by a pilot study in 15 participants, who will be assigned to the control group to~     determine the basic rate of referred pain in the shoulder in our people and improve test~     management.~   "
83964|NCT02467972|"~     The addition of fructans or unripe banana flour to frozen meals can change the hormonal~     parameters related to hunger and satiety, improve the bowel movements and increase in colonic~     bacteria population measured by microbiological determinations (qPCR). The inulin no can~     change bowel movements and increase in colonic bacteria population measured by~     microbiological determinations (qPCR)~   "
83965|NCT02467959|"~     The aim of the study is to evaluate the diagnostic yield and accuracy of bedside emergency~     physician performed ultrasound in the diagnosis of acute appendicitis.~   "
83966|NCT02467946|"~     Treatment outcome with ABVD in elderly patients remains inferior to adults. Moreover,~     Bleomycin-induced lung toxicity in the elderly has been reported as high as 46%. For these~     reasons, questions arise whether ABVD could be still considered the standard treatment in HL~     patients aged > than 60. Regimens containing other alkylators such as CHOP proved even~     superior to ABVD, with a 3-y PFS of 67%. Frontline treatment of advanced-stage HL with~     Brentuximab Vedotin (BV) in association with AVD (Doxorubicin, Vinblastine, Dacarbazine)~     proved very active in a pioneer study, reporting the preliminary results of a phase 1~     multicentre trial, in which the percentage of patients achieving CR was as high as 92%. For~     all these reason the investigators decided to test the association of an alkylator with an~     innovative mechanism of action and a very safe toxicity profile in the elderly such as~     Bendamustine (Be) with BV in untreated elderly HL patients.~      The combination of BV and Be, investigated in this study, might represent an innovative~     treatment alternative for HL patients older than 60 years of age, especially for those of~     them in whom ABVD chemotherapy, the current standard front-line treatment, is not suitable.~     However, even when ABVD is given as upfront treatment for elderly HL patients, it is~     associated with substantial dose reduction, treatment delay, toxicity, and treatment-related~     mortality, with treatment outcomes remaining much inferior to those obtained in younger~     patients. This drug association is expected to be safe, well-tolerated and to demonstrate~     higher efficiency compared with ABVD. In this setting, it is expected that this therapy could~     be offered to the large majority of elderly patients with a full treatment completion reached~     in up to 80% of these patients.~      Thus, the aim of this study will be to assess safety and efficacy of the above association.~   "
83967|NCT02467933|"~     Abusive prescribing exposes patients to unnecessary health risks and results in wasteful~     public expenditures. This study will evaluate an innovative approach to fighting abusive~     prescription: sending letters to suspected inappropriate prescribers warning them that they~     are outliers compared to their peers and have been flagged for review. The study will target~     high prescribers of Seroquel (Quetiapine), an atypical antipsychotic. Using claims data, the~     investigators will assess the effect of the letters on prescribing of Seroquel, receipt of~     Seroquel by patients, substitution behavior by prescribers and patients, and health outcomes~     of patients.~   "
83968|NCT02467920|"~     Efficacy and Safety of Basal Insulin Glargine Combination with Exenatide bid vs Switching~     Premix Human Insulin to Aspart30 in T2DM with Inadequate Glycaemic Control on Premixed Human~     Insulin and Metformin: a Randomized, Open, Parallel trial.~   "
83969|NCT02467907|"~     This study is to assess safety as defined by the frequency and severity of gastrointestinal~     (GI) perforation/fistula, GI-vaginal fistula and genitourinary (GU) fistula in participants~     treated with bevacizumab 15 milligrams per kilogram (mg/kg) in combination with paclitaxel~     and carboplatin, all repeated every 3 weeks, for recurrent, persistent or metastatic cervical~     cancer. In addition, this study will include evaluation of the overall safety profile of~     bevacizumab in combination with paclitaxel and carboplatin in this setting, assessment of GI~     perforation/fistula, GI-vaginal fistula and GU fistula events over time, and evaluation of~     efficacy.~   "
83970|NCT02467894|"~     A two-group randomized clinical trial testing whether group-based care will help improve~     blood pressure control in adult and adolescent patients with chronic kidney disease and~     hypertension.~   "
83971|NCT02467881|"~     Diabetes Prevention Program translational efforts, such as the Group Lifestyle Balance~     Program (GLB), have been shown to be effective in reducing weight and modifying diabetes and~     CVD risk factors in a variety of diverse community settings. Although one of the two primary~     goals of these DPP translation programs focuses on increasing physical activity levels, few~     published DPP translation studies reported results on change in physical activity with only~     one study reporting activity levels from an objective measurement instrument. In order to~     completely understand the role that physical activity plays in making healthy lifestyle~     change, it is critical that we validate the impact of activity using a valid and reliable~     objective measure. In addition, current studies suggest that decreasing time spent sitting~     may have a positive health impact separate from the effects of participating in planned bouts~     of moderate intensity activity. Therefore, we propose to examine the impact of a modified~     version of the GLB program, which will focus on decreasing sedentary/sitting behaviors. The~     results of this project will provide information regarding best options for physical activity~     within lifestyle intervention programs, focusing both on verifying the current role of~     physical activity in lifestyle intervention using an objective measure and on examining an~     alternative intervention option for translation efforts.~   "
83972|NCT02467868|"~     This is a Multicenter, Double-Blind, Randomized, Comparative Efficacy and Safety Study of~     MYL-1401H and Neulasta (Pegfilgrastim) in Stage II/III Breast Cancer Patients Receiving~     Neoadjuvant or Adjuvant Chemotherapy.~   "
83973|NCT02467855|"~     The purpose of this study is to evaluate blood pressure (BP) goal attainment in adult~     participants with essential hypertension.~   "
83974|NCT02467842|"~     All participants will receive a single dose of their assigned vaccine on Day 0. They will be~     followed up for immunogenicity and safety through Day 21 post-vaccination. The serious~     adverse events are collected for 6 months post-vaccination.~   "
83975|NCT02467829|"~     The aims of this study are to investigate what effect altering handle height of posterior~     walkers has on forces through the walker, posture, efficiency, stability, speed, turning and~     comfort, and to obtain data which helps therapists understand the bio-mechanics involved~     during use and if this alters depending on age, posture or strength. All participants will~     have cerebral palsy. This will allow informed prescription of walkers and identify potential~     for redesign to improve efficiency, promote strengthening or improve posture to maximise~     children's potential to continue functional walking into adulthood.~   "
83976|NCT02467816|"~     This study will evaluate an innovative school lunch intervention that is designed to increase~     school meal participation and improve dietary intake among middle and high school students.~   "
83977|NCT02467803|"~     Fractures of the proximal humerus and the humeral head are most common injuries and the~     management is challenging. Functional therapy with short immobilization, followed by an~     accelerated physiotherapy protocol, is a simple, convenient, noninvasive, and efficient~     management option. This prospective randomized study is aim to assess the function of the~     upper extremity of patients who will be assigned to nonoperative treatment of a proximal~     humeral fracture. The primary objective is the Constant score. Secondary objectives are the~     Disabilities of the Arm, Shoulder, and Hand (DASH) instrument, measurement of shoulder range~     of motion (ROM), pain and depression level with Beck Depression Scale.~   "
83978|NCT02467790|"~     To compare and analysis pharmacokinetics of PEX 168 in patients with renal insufficiency or~     normal renal function who were administrated subcutaneously single dose PEX168.To evaluate~     dose adjustment of PEX168 administered in patients with renal insufficiency and provide a~     scientific basis in patients with renal insufficiency of rational drug use.~   "
83979|NCT02467777|"~     Comparison of forced air and conductive warming devices in outpatient orthopaedic surgeries.~   "
83980|NCT02467764|"~     The hip or knee is a validated treatment of end-stage osteoarthritis, and these interventions~     commonly make a significant improvement in the quality of life of patients. Infection can~     occur in 1-5% of cases. Diagnosis is often difficult, but the knowledge of infected or not~     infected character directly influences the surgical conduct. It is therefore recommended that~     the positive or negative diagnosis is made in the most reliable way possible, but no single~     element only allows a low diagnosis. The concomitant use of several clinical, radiological~     and aggregated into a composite score history could help facilitate this preoperative~     approach during reoperation on prosthetic joint~   "
83981|NCT02467751|"~     Metabolic profile in women of different body composition with polycystic ovary syndrome.~   "
83982|NCT02467738|"~     This pilot clinical trial studies cesium Cs 131 brachytherapy in treating patients with head~     and neck cancer that has come back (recurrent) and can be removed by surgery. Brachytherapy,~     also known as internal radiation therapy, uses radioactive material placed directly into or~     near a tumor to kill tumor cells. Radioactive drugs, such as cesium Cs 131, may carry~     radiation directly to tumor cells and not harm normal cells. Permanently implanting cesium Cs~     131 into the wound bed after surgery may help treat microscopic cancer cells that may be in~     the tissue after surgical removal of the tumor.~   "
83983|NCT02467725|"~     The purpose of the study is to determine if a dynamic embryo microenvironment impacts embryo~     development and reproductive potential in comparison to static culture.~   "
84144|NCT02465632|"~     This is a randomized, double-blind, multiple-site, placebo-controlled, parallel-group study,~     designed to compare the efficacy and safety of generic Clindamycin 1%/ Benzoyl peroxide 5%~     topical gel (Glenmark Generics, Ltd), and the marketed product BenzaClin® Topical Gel,~     Clindamycin 1%/ Benzoyl peroxide 5% (Valeant Pharmaceuticals, US) in the treatment of acne~     vulgaris.~   "
83984|NCT02467712|"~     It is generally accepted that the fungal infection on a joint prosthesis is to be treated in~     two surgical time: implant removal and prosthetic reconstruction. The service took the option~     for over 10 years to treat bacterial infections in joint replacement by a change in time. In~     four recent cases the diagnosis initially suspected of bacterial infection has been restated~     on intraoperative bacteriological examinations fungal infection. It is therefore a~     potentially harmful side effect of the chosen treatment option, but 4 patients in question~     were all cured of their fungal infection after a postoperative antifungal therapy. The~     objective of this study is to report these cases for discussion on the therapeutic choices in~     fungal infections on joint replacement.~   "
83985|NCT02467699|"~     The knee prosthesis is a validated treatment for end-stage osteoarthritis, and this~     intervention usually provides a significant improvement in the quality of life of patients.~     However, a significant percentage of patients (up 30%) say disappointed with the outcome of~     the intervention. One hypothesis that could explain these poor results might be poor~     adaptation of the implants to the patient's anatomy, resulting in a non-physiological~     kinematics for the patient. Multiple studies try to obtain an individual adaptation of the~     intervention according to multiple criteria. The measurement of the kinematics of the knee~     before surgery could participate in this process.~   "
83986|NCT02467686|"~     The purpose of this study is to evaluate the Cimicifuga racemosa effects on the sexuality of~     women with Breast cancer using tamoxifen or aromatase inhibitor through questionnaires.~   "
83987|NCT02467673|"~     The study aims to asses the effects of micronized (MIC) and nanoparticulate (NANO)~     transdermal hormone therapy (THT) on blood pressure, ultra-sensitive C-reactive protein~     (CRP), and cardiovascular risk factors in postmenopausal women.~   "
83988|NCT02467660|"~     1. Telephone Eligibility Screening~        2. Baseline Visit, includes online questionnaires, physical measures, cognitive tasks,~          voice recordings, physical recordings of brain waves, heart rate, breathing rate, and~          sweat during computer tasks, collect saliva samples and respond to handheld device that~          rings randomly for the two days following the visit~        3. Randomized to receive (a) an internet-based Mindfulness Meditation program, (b) an~          internet-based Health & Wellness Education program, or (c) no training. IF assigned to~          receive a training program, participants complete weekly one-hour online trainings and~          daily home practice for 6 weeks~        4. Endpoint Visit (same as Baseline), scheduled 8 weeks after Baseline~        5. All participants receive Meditation and Education programs after the Endpoint Visit~        6. Online questionnaire follow-up 6 months after the Endpoint~   "
83989|NCT02467647|"~     To investigate the efficacy of the combination of Thalidomide and Huang-Lian-Jie-Du-Tang on~     the patients with multiple myeloma in maintain therapy.~   "
83990|NCT02467634|"~     A fellow eye controlled study of HUCNS-SC sub-retinal transplantation in subjects with~     bilateral GA AMD. All subjects will be assigned to HUCNS-SC transplantation.~   "
83991|NCT02467621|"~     Stress ulcer prophylaxis (SUP) is standard of care in the intensive care unit (ICU), however~     the quantity and quality of evidence is low and potential harm has been reported.~      The aim of the SUP-ICU trial is to asses the overall benefits and harms of SUP with proton~     pump inhibitor in adult critically ill patients in the ICU.~   "
83992|NCT02467608|"~     Assess the Efficacy of HUEXC030 as Add-on Excipient to Eradicate Anti-Tuberculosis Drugs~     Induced Hepatic Injury ( ATDH ) in Subjects with Pulmonary Tuberculosis~   "
83993|NCT02467595|"~     This study aimed to compare the effect of no muscle relaxants and reduced-dose rocuronium on~     the anesthetic induction and emergence with fentanyl in children undergoing~     adenotonsillectomy.~   "
83994|NCT02467582|"~     Following complete resection of their primary tumor, potentially eligible stage II or stage~     III colon cancer patients will undergo central PIK3CA testing. Patients with somatic~     mutations will be 2:1 randomized to daily aspirin 100 mg versus placebo for a total of 3~     years or until disease recurrence, patient death or withdrawal of consent, whichever occurs~     first. Patients will be followed up for 10 years from the date of surgery.~      The intake of aspirin or placebo is independent of adjuvant chemotherapy, and does not impact~     on the indication to give (or not to give) adjuvant chemotherapy.~   "
83995|NCT02467569|"~     The purpose of this study is to assess the pharmacokinetics，safety and tolerability of~     Hemay020 and to determine the recommended dose for future Phase II study as well as to obtain~     preliminary information on the efficacy of Hemay020 in subjects with solid tumors. The study~     will be conducted in two parts. Part one, testing will be done on up to 16-31 subjects to~     determine the safety and tolerability of Hemay 020 in patients with advanced solid tumors.~     Part two, another 16-24 subjects with advanced or metastatic NSCLC, will be added to the~     trial to better define the tolerability and preliminary efficacy of Hemay020.~   "
83996|NCT02467556|"~     A ten week open label study intervention to evaluate the outcome for a psychological~     intervention combined with physiotherapy and medication with memantine-morphine in 10 CRPS~     patients.~   "
83997|NCT02467543|"~     Dysmenorrhea (painful menstruation) is a common gynaecological disorder that is prevalent in~     more than 50% of women during their reproductive years. Primary dysmenorrhea describes cyclic~     uterine pain without any identifiable or underlying causes. Menstrual pain results as a~     consequence of endometrial ischemia, high levels of prostaglandins and other inflammatory~     mediators. Conventional treatment for primary dysmenorrhea consists of non-steroidal~     anti-inflammatory drugs and oral contraceptives, which may have adverse effects. Viburnum~     opulus (Cramp bark) is a homoeopathic remedy well indicated for the treatment of~     dysmenorrhea. While there are studies using Viburnum opulus in its herbal form, there is no~     research assessing its efficacy in the homoeopathic form.~      The aim of this study is to determine the efficacy of Viburnum opulus 3X in the treatment of~     primary dysmenorrhea as measured with the modified Short Form McGill pain questionnaire~     (SF-MPQ-2) and visual analogue scale (VAS) respectively.~   "
83998|NCT02467530|"~     This is an intervention study of the effects of food preparation on the gut bacteria in~     patients with end stage renal disease on peritoneal dialysis. This is a dietary intervention~     consistent of consuming low amounts of advanced glycation end products (AGEs), the products~     of protein and sugar interaction during food processing and preparation using high direct~     heat.~   "
83999|NCT02467517|"~     The primary outcome is to compare the analgesic efficacy of intravenous ketamine treatment to~     that of a placebo in patients with refractory neuropathic pain.~      The secondary outcomes are:~        1. - To compare the additive analgesic efficacy of prior administration of magnesium~          sulfate to that of placebo and ketamine only, on the effectiveness of intravenous~          ketamine treatment,~        2. - To study the evolution time of pain and analgesia after the intravenous administration~          of ketamine and placebo,~        3. - To study the correlation of the analgesic response to administered products~          respectively ketamine, ketamine and magnesium sulfate, placebo.~   "
84000|NCT02467504|"~     Rheumatoid arthritis (RA) is an immune-mediated inflammatory disease, characterized by~     symmetric poly-arthritis usually involving the small joints of the hands and feet. In~     addition, various extra-joint manifestations may develop. Several immunomodulating agents~     have been attempted in the treatment of RA without achieving satisfactory results.~     Dysfunction of regulatory T (Treg) cells has been detected in diverse autoimmune diseases,~     which can be promoted by interleukin-2 (IL-2). The investigators hypothesized that low-dose~     IL-2 could be a novel therapy in active RA patients. This clinical study will test the~     efficacy and safety of low dose IL-2 treatment in RA. The investigators perform a~     single-centre, double-blind pilot trial with hrIL-2 in RA. The investigators evaluate the~     effectiveness and safeness of low-dose hrIL-2 for RA by randomized controlled study (hrIL-2~     (N = 30) + Methotrexate (MTX)+ Loxoprofen versus placebo+MTX + Loxoprofen group (N = 30)).~   "
84001|NCT02467491|"~     The purpose of this study is to explore the feasibility and acceptability of a new physical~     activity technology (Jintronix) based on TV screen, virtual games and motion sensing cameras~     among pre-disabled older adults.~   "
84002|NCT02467478|"~     Type 2 diabetes is a national epidemic. Diabetes has undesirable effects on blood vessels~     which may contribute to heart disease. Endothelial Progenitor Cells (EPCs) are found in the~     blood. Research has shown that improving the survival of these special blood cells may~     decrease the harmful effects of diabetes on blood vessels and reduce or reverse heart~     disease. Linagliptin is an Food and Drug Administration (FDA) approved prescription medicine~     used along with insulin or with oral medications to lower blood sugar in people with Type 2~     diabetes. It is in a class of diabetes medication called Dipeptidyl peptidase-4 (DPP-4)~     inhibitors. DPP-4 inhibitors have been shown to increase EPCs in patients with Type 2~     diabetes.~      Hypothesis: Both type 2 diabetes and Chronic Kidney Disease (CKD) are associated with poor~     stem cell number and function. Poor viability and function of EPCs in CKD and diabetes The~     investigators hypothesize that use of Linagliptin (along with Insulin) may help reduce~     cardiovascular risk by improving EPC survival and function above and beyond adequate glucose~     metabolism control~   "
84003|NCT02467465|"~     The plantar fasciitis (PF) is the most common cause of pain on the underside of the heel.~     About 10% to 20% of the population suffer once during their lifetime. PF concept began to~     describe at the end of XX century through the discovery of new clinical and histopathological~     signs of the plantar fascia. The difficulty of diagnosis, understanding and treatment of PF~     require us to develop new treatment avenues to improve the approach and the understanding of~     it. Dry needling (DN) as a treatment of myofascial pain syndrome (MPS) and myofascial trigger~     points (MTP) of muscle associated with the pathology, it may be a good treatment strategy, as~     demonstrated in the treatment of MPS in other body regions such as the neck, shoulder or the~     lumbar spine.~   "
84004|NCT02467452|"~     The purpose of the study is to demonstrate the triple combination of beclometasone~     dipropionate + formoterol fumarate + glycopyrronium bromide is effective in term of quality~     of life in COPD patients (Chronic Obstructive Pulmonary Disease).~   "
84005|NCT02467439|"~     The primary purpose of this research is to assess the benefit of an unaware intervention~     package for identifying high risk persons who are unaware of their HIV infection status.~     This intervention package includes screening for acute HIV infection, contract sexual partner~     referral, and peer referral.~   "
84006|NCT02467426|"~     This is an observational study of isolated thoracic perfusion with subsequent hemofiltration~     to lower the concentration of the cytotoxic drugs as a locoregional therapeutic strategy in~     malignant pleural mesothelioma.~   "
84007|NCT02467413|"~     The primary objective of this study is to evaluate the efficacy of BAC patients with~     Alzheimer's disease or vascular dementia.The secondary objective of this study is to evaluate~     the safety of BAC patients with Alzheimer's disease or vascular dementia.~   "
84008|NCT02467400|"~     This study is designed to answer the question as to whether the sympathetic nervous system is~     an important determinant of bone metabolism in humans.~   "
84009|NCT02467387|"~     A phase IIa study to assess the safety and preliminary efficacy of intravenous dose of~     ischemia-tolerant Allogeneic Mesenchymal Bone Marrow Cells in subjects with non-ischemic~     heart failure.~   "
84010|NCT02467374|"~     The purpose of this study is to find out more about how the brain stores emotional learning~     in obsessive-compulsive disorder (OCD). In particular, we would like to understand how human~     beings learn not to fear. We are also interested in learning about how behavioral therapy~     (BT) for OCD affects emotional learning in the brain. We hope this study will help us~     understand why people with OCD cannot control unwanted fear and to develop better treatments~     for adults with OCD. Patients will be randomly assigned (like the flip of a coin) to receive~     12 weeks of BT or 12 weeks of waitlist, followed by 12 weeks of BT. We are seeking~     individuals 18-60 with OCD and individuals with no psychiatric history. Participation~     includes a diagnostic evaluation, 12 weeks of BT or 12 weeks of waitlist followed by BT,~     questionnaires, and up to six (6) MRI scans. You may receive up to $500 for your~     participation and reimbursement for parking.~   "
84011|NCT02467361|"~     This is an open label, multi-center, Phase 1/2 study of BBI608 administered in combination~     with immunotherapy in adult patients with advanced cancers. The goal of the study is to~     determine the RP2D of BBI608 in combination with each of the immunotherapeutic agents.~   "
84012|NCT02467348|"~     All consecutive patients admitted in ILBS from MAY 2015 to DECEMBER 2016.ACLF (Acute on~     chronic Liver Failure). ACLF will be randomize into~      Group 1: MVP (Modest Volume Paracentesis) OF Less than 5 liters with IV albumin at a dose 8~     gms/L of ascitic fluid~      Group 2: MVP (Modest Volume Paracentesis) of Less than 5 liters without albumin~   "
84016|NCT02467296|"~     Currently, the recommendations for sodium intake restriction for patients with heart failure~     are mostly based on expert consensus and observational evidence, whereas smaller randomized~     studies have actually suggested that strict dietary sodium reduction may be harmful in heart~     failure. In the present clinical trial pilot study, the investigators plan to collect data on~     enrollment rates, compliance, outcomes, and safety of a 12-week dietary intervention in heart~     failure patients, with prepared food containing two different levels of sodium (1,500 mg and~     3,000 mg) daily, followed by a 12-week surveillance for safety and effectiveness. The goal is~     to inform the design of a fullscale clinical trial that will provide more definitive evidence~     for dietary sodium recommendations in heart failure.~   "
84017|NCT02467283|"~     Current concepts of the causes of periodontitis implicate a bacterial infection as the~     primary cause of the disease. Several bacterial species residing in a biofilm on tooth~     surfaces are closely associated with periodontitis. Chronic periodontitis (CP) is initiated~     and sustained by bacterial plaque, but host defense mechanisms play an integral role in its~     pathogenesis.~      Gene expression profiling is a powerful means of generating comprehensive genome-level data~     sets on diseases such as cancer, asthma, rheumatoid disorders and periodontitis, and provides~     significant insight information for these diseases. Gene expression profiling may provide an~     evidence for involving genes in the pathogenesis of CP and generate further information other~     than clinical signs and symptoms of CP.~      The aim of this study was to identify gene-expression patterns of patients with chronic~     periodontitis by whole-transcriptome gene-expression analyses.~   "
84018|NCT02467270|"~     The purpose of this study is to compare and characterize the efficacy and safety of ponatinib~     in participants with resistant chronic myeloid leukemia (CML) in chronic phase (CP) in a~     range of doses.~   "
84019|NCT02467257|"~     The purpose of this study is to determine whether Gum Arabic is effective as fetal hemoglobin~     inducing agent for sickle cell anemia patients.~   "
84020|NCT02467244|"~     The aim of this study is to evaluate plasma adiponectin level, insulin resistance,~     cardiovascular risk and their correlation (if any) in patients with hypothyroidism and also~     to investigate the effect of levothyroxine on these parameters. The study may explore the~     lacunae in present treatment protocol and can suggest the possibilities of add-on therapies~     for a better management.~   "
84021|NCT02467231|"~     Women of reproductive age who will receive treatment for cancer that includes chemotherapy~     may participate in a study measuring ovarian function over time. Eligible women are asked to~     complete a questionnaire, a menstrual diary, a brief physical examination, an ultrasound, and~     a blood test before, during and after cancer treatment.~   "
84022|NCT02467218|"~     Fibromyalgia (FM) is a chronic pain condition affecting several millions of Canadians.~     Although the etiology and pathophysiology are poorly understood, there is a well-recognized~     association between muscular pain in fibromyalgia and muscular hypoperfusion, hypoxia,~     abnormal muscle metabolism and oxidative stress. Currently there is no cure for FM.~     Pharmacological and non-pharmacological strategies are directed to control symptoms such as~     pain, fatigue, non-restorative sleep and depression.~      Hyperbaric oxygen therapy (HBOT) is an intermittent inhalation of 100% oxygen in a hyperbaric~     chamber at a pressure higher than 1 absolute atmosphere. Physiological effect of HBOT is~     based on a dramatic increase in the amount of dissolved oxygen carried by the blood which~     enables oxygenation of ischemic areas with compromised circulation. It also activates~     oxidant-antioxidant system, stimulates angio- and neurogenesis, modulates inflammatory~     response, induces brain neuroplasticity and possesses analgesic effect.~      While some interventions offer benefit for some patients, additional treatment alternatives~     are needed for patients with FM in whom currently available options are either ineffective or~     poorly tolerated. Given its physiological effect, HBOT could be considered as a potential~     therapy for treatment of underlying muscular hypoxia, optimizing oxidant- antioxidant system~     and controlling FM symptoms. The results from this study could therefore provide new~     information supporting the basic science underling the pathophysiology of this disease and~     stimulate novel therapies for patients suffering with FM.~   "
84023|NCT02467205|"~     The overall aim of this randomized control trial study is to investigate the effectiveness of~     a six-month, community based, pedometer supported, walking programme, along with an education~     programme incorporating behavioural change techniques on steps count and sedentary time,~     disease activity, functional capacity and cardiovascular risk of people within the first five~     years of being diagnosed with RA.~   "
84024|NCT02467192|"~     Diagnosis of pneumonia in the elderly is difficult because of the poor sensitivity and~     specificity of clinical signs as well as images from chest radiography (RT). New diagnostic~     tools such as thoracic low-dose computed tomography (CT), which exposes the patient to a weak~     dose of irradiation, could improve diagnosis. Moreover, low-dose CT could provide additional~     accuracy in the etiological clarification of pneumonia in elderly people.~      As a first step, the investigators aim to perform a 1 year (12 months of inclusion + 3 months~     of follow-up) prospective study including the Divisions of Internal Medicine, Rehabilitation,~     Geriatrics and Radiology of the University Hospitals of Geneva. In this study, patients >65~     years old with a clinical suspicion of low respiratory tract infection (LRTI) will be~     included. They will be prescribed antimicrobial therapy. Both chest radiography and low-dose~     thoracic CT will be performed within the first 72 hours after admission, as will blood tests~     and a nasopharyngeal swab.~      The clinician's diagnosis, both before and after the results of the CT, will be compared at~     the end of the study to the adjudication committee's diagnostic opinion which will have~     access to all available clinical, laboratory and chest X-ray data and which will be~     considered the gold standard. At the end of the study, all the CT images will be~     blind-reviewed by two experts in radiology. The impact of CT scanning in the diagnosis of~     pneumonia will be assessed, both for its sensitivity and specificity in this population.~      During the first 12 months of the study, all patients will undergo a systematic~     nasopharyngeal swab at admission and at discharge, from which eluates will be conserved.~     During the next 12 months, virological and bacteriological polymerase chain reactions (PCR)~     will be performed, using new diagnostic tools, in order to determine the etiological~     diagnosis in this population and to evaluate the impact of the new tools in the management of~     pneumonia for this population.~      Analysis of these data will allow clinical, radiological and microbiological correlation.~   "
84025|NCT02467179|"~     The purpose of this study is to compare standard manual and robotically controlled catheter~     ablation of the cavo-tricuspid isthmus (CTI) as a treatment for atrial flutter. Ablation of~     the CTI is standard treatment for patients with a history of atrial flutter, and those~     undergoing ablation for atrial fibrillation. Both manual and robotic catheter manipulation~     are used in standard clinical practice at The University of California, San Diego (UCSD) for~     ablation.~   "
84145|NCT02465619|"~     The study will be conducted on patients admitted to Department of Hepatology from MARCH 2015~     to DECEMBER 2016 at ILBS, New Delhi.All patients presenting to ILBS fulfilling the inclusion~     criteria will be included in the study and will be categorized and evaluated. The patient~     will followed over a period of 3 months.~   "
84026|NCT02467166|"~     The purpose of this study is to determine if the use of Circa™ temperature monitoring system~     during ablation procedures will reduce the risk of esophageal lesions or damage. Esophageal~     lesions caused by ablation could later develop into a potentially fatal atrio-esophageal~     fistula, which is hole between the upper chamber of the heart and the esophagus. Although~     development of atrio-esophageal fistula following atrial fibrillation ablation is extremely~     rare, the complication is severe and potentially life-threatening. Therefore, monitoring of~     esophageal temperatures has been adopted to prevent the development of esophageal lesions.~     The Circa™ temperature monitoring system allows cardiac electrophysiologists to monitor and~     thereby limit temperatures as well as duration of ablation in the esophagus throughout the~     procedure.~   "
84027|NCT02467153|"~     This study aims to determine whether vitamin D3 supplementation is any more effective in~     improving musculoskeletal function when combined with exercise training compared with~     exercise training alone.~   "
84028|NCT02467140|"~     A clinical study evaluating acute and chronic pain following laparoscopic inguinal hernia~     repair comparing the ProGripTM self- fixating mesh with tack fixation.~   "
84029|NCT02467127|"~     To date there are conflicting data concerning a correlation between plasma vitamin D levels~     and headache.~      The aim of this study was to evaluate plasma vitamin D levels in patients with headache~     admitted to the Center of Headache of Pugliese Ciaccio Hospital.~   "
84030|NCT02467114|"~     Attention can be defined as the preparedness to rapidly and accurately respond to stimuli~     coming from the investigators environment and to effectively select between relevant and~     irrelevant information. According to a current model, visual attentional control is based on~     two separate groups of brain regions, so called brain networks. These networks control~     different attentional aspects (e.g., spatial/non-spatial attention) and they interact with~     each other. A disruption of these interactions can lead to attentional disorders such as~     hemispatial neglect. Patients with hemispatial neglect have difficulties directing their~     attention to the left visual field and they act as though the latter does not exist.~      To date, the interactions between the two attentional networks are poorly understood. The aim~     of this study consists in further clarifying different aspects of these interactions and~     their influence on visual perception in healthy participants and in patients with hemispatial~     neglect. Transcranial magnetic stimulation (TMS) will be the principal method applied in this~     study. TMS is a painless and non-invasive method, with which the activity of brain areas can~     be influenced temporarily. This allows us to draw conclusions regarding the functions and~     interactions of these brain areas.~      This study is designed to have a significant impact on the basic understanding of attentional~     control in the human brain and it can benefit the comprehension and treatment of attentional~     disorders, such as hemispatial neglect.~   "
84031|NCT02467101|"~     The purpose of this study is to determine the efficacy of treatment with intralesional~     injection of corticosteroids on the treatment of Frontal Fibrosing Alopecia (compared with~     placebo), between three months, six months and baseline.~   "
84032|NCT02467088|"~     Premenstrual Syndrome (PMS) is a group of physical, mental and behavioural symptoms that~     occur cyclically through the luteal phase of the menstrual cycle and resolve within three~     days of the onset of menstruation. Many women are affected by the physical and psychological~     symptoms of PMS. The symptoms of PMS can change behaviour and wellbeing of women which has an~     impact on families, social life and work. Research has shown that women with PMS reported~     additional days missed at work compared to women that do not suffer with PMS. A study done by~     Brohi et al. (2011) showed that PMS is a common problem that occurs in 81.25% of women and~     has an adverse impact on a woman's quality of life. Conventional treatment is limited, not~     always effective and is associated with many side effects. Research using individualised~     homeopathic treatment, known as the homeopathic similimum, in PMS has shown to be well~     tolerated as well as have a positive impact on the symptoms of PMS although further research~     is warranted in this regard. There have not been any studies done on homeopathic treatment in~     Indian females in South Africa.~      The aim of this study is to determine the effect of individualised homeopathic treatment on~     females of Indian origin who are suffering with symptoms of PMS, using observational studies.~   "
84033|NCT02467075|"~     This double-blinded placebo-controlled study will examine the incidence and significance of~     contrast-induced acute kidney injury following IV iodine-based contrast material~     administration in subjects with stage IIIB or stage IV chronic kidney disease.~      Subjects will be scheduled for clinically indicated CT of the abdomen and/or pelvis to~     evaluate for suspected intra-abdominal infection. Subjects will be randomized to receive~     either weight-based low-osmolality iodinated contrast material or saline. The primary outcome~     measure will be the incidence of stage II AKI by AKIN (Acute Kidney Injury Network) criteria.~   "
84034|NCT02467062|"~     The aim of the investigator is to implement 4D FLOW MRI technique into a clinical setting and~     evaluate the blood flow pattern and wall sheer stress in patients with aortic and/or aortic~     valve diseases.~   "
84035|NCT02467049|"~     In the prevention of thrombosis related to catheter placement it is important to have a right~     position of the catheter tip. Therefor we want to assess which technique is the most~     successful in the placing of a PICC.~   "
84036|NCT02467036|"~     The purpose of this study is to evaluate whether a behavioral weight loss group in~     conjunction with a prescribed breakfast can help children between 8 and 12 years of age~     change their behaviors to help them lose weight and become healthier.~   "
84050|NCT02466854|"~     The BleeMACS (Bleeding complications in a Multicenter registry of patients discharged with~     diagnosis of Acute Coronary Syndrome) registry is an international observational database of~     bleeding outcomes for patients who are discharged with diagnosis of ACS and underwent~     Percutaneous Coronary Intervention (PCI), including myocardial infarction or unstable angina.~      BleeMACS registry enrolls a total of more than 15,000 patients, including data from 16~     hospitals in 11 countries: North America (Canada), South America (Brazil) Europe (Germany,~     Netherlands, Poland, Spain, Italy, Macedonia, Greece), and Asia (Japan and China).~      The end-point of this study is to characterize patients at high risk of bleeding and to~     develop a risk score to accurately predict the risk of major bleeding within the first year~     after discharge from the hospital for an ACS.~   "
84146|NCT02465606|"~     The primary objective for this study is to evaluate the safety of lebrikizumab compared with~     Topical Corticosteroids (TCS) alone in patients with persistent moderate to severe Atopic~     Dermatitis (AD) that is inadequately controlled with TCS.~   "
84037|NCT02467023|"~     The purpose of this research study is to see if electrical stimulation of the leg muscles~     will improve strength in patients receiving mechanical ventilation in the intensive care unit~     (ICU). ICU care frequently results in chronically critically ill (CCI) patients. Some CCI~     patients develop persistent inflammation/immunosuppression and catabolism syndrome (PICS),~     and they have morbid long-term outcomes. CCI patients with PICS often develop severe limb~     muscle atrophy, weakness and accelerated protein catabolism. Limb muscle dysfunction in PICS~     is due to many factors including sepsis/inflammation, proteolysis, apoptosis, and inactivity.~     Despite the seriousness of limb muscle weakness in CCI patients receiving mechanical~     ventilation, little is known about exercise strategies to treat this problem. There is~     limited knowledge about how strength training impacts inflammation and catabolism in CCI~     patients. In addition, an assessment of the effect of exercise on markers of inflammation and~     protein catabolism on muscle samples obtained with biopsy techniques and venous blood samples~     will be performed. This project will further understanding of how treating CCI-related muscle~     weakness with strength training cannot only improve muscle function, but also potentially~     blunt the inflammation and catabolism of PICS.~   "
84038|NCT02467010|"~     Bortezomib and cyclophosphamide in combination with dexamethasone has already demonstrated~     high response rates in refractory multiple myeloma. Low dose continuous cyclophosphamide,~     also called metronomic scheduling, minimize toxic side effects and eliminate the obligatory~     rest periods. Combining cyclophosphamide with bortezomib might target distinct aspects of a~     myeloma functionality.~      The objectives of the present study are whether patients with refractory or relapsed multiple~     myeloma after reinduction with bortezomib, cyclophosphamide and dexamethasone will benefit~     from maintenance therapy with bortezomib and cyclophosphamide with acceptable side-effects.~     Recently two studies have shown with thalidomide that maintenance therapy might improve EFS~     and one study also the OS.~   "
84039|NCT02466997|"~     Multicentric French parallel double-blind randomized versus placebo study~   "
84040|NCT02466984|"~     Subcutaneous (SC) route has become a standard of care of many drugs administration in~     palliative medicine. A preliminary study showed that, although it was widely adopted among~     palliative care practitioners for routinely prescribed medications, standards of proof are~     still lacking for many molecules. Among them, metoclopramide is a largely employed drug for~     nausea and vomiting treatment, particularly in palliative care and oncology. Therefore, the~     investigator aim to study absorption and efficacy of subcutaneous administration of~     metoclopramide.~   "
84041|NCT02466971|"~     This randomized phase II trial studies radiation therapy and cisplatin with triapine to see~     how well they work compared to the standard radiation therapy and cisplatin alone in treating~     patients with newly diagnosed stage IB2, II, or IIIB-IVA cervical cancer or stage II-IVA~     vaginal cancer. Radiation therapy uses high energy protons to kill tumor cells and shrink~     tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the~     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Triapine may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth. It is not yet known whether radiation therapy and~     cisplatin are more effective with triapine in treating cervical or vaginal cancer.~   "
84042|NCT02466958|"~     The purpose of this study is to examine the effects of levomilnacipran (FETZIMA) compared to~     placebo for the treatment of depression in older adults.~   "
84043|NCT02466945|"~     The aim of this clinical trial is to evaluate the tolerance and efficacy of a dental gel in~     patients with dentinal hypersensitivity.~   "
84044|NCT02466932|"~     This study evaluates the effects of birth weight (BW) on ocular anterior segment parameters~     in preschool children using the Galilei Dual-Sheimpflug Analyzer (GD-SA). Children were~     measured by GD-SA and relationships between all anterior segment parameters obtained by this~     device and birth weight were analyzed.~   "
84045|NCT02466919|"~     The study aims to evaluate H. pylori eradication rate in diabetic patients by using novel~     10-day levofloxacin-based concomitant therapy compared with conventional 10-day sequential~     therapy.~   "
84046|NCT02466906|"~     This study is to investigate the efficacy and safety of rhGM-CSF as adjuvant immunotherapy~     for patients with resectable stage III colon cancers.~   "
84047|NCT02466893|"~     Intravenous (IV) tissue plasminogen activator (tPA) administration has been shown to be safe~     and effective for treatment of AIS within 3 hours of symptom onset, and newer evidence has~     shown potential benefit out to 4.5 hours. Mechanical thrombectomy for AIS patients has been~     shown in clinical trials to be safe up to 8 hours after symptom onset. Recent trials~     utilizing advanced imaging to identify patients with large vessel occlusions amenable to~     intra-arterial thrombectomy (IAT) have shown superiority endovascular therapy over medical~     therapy to result in improved patient functional outcomes. Pilot data utilizing the ADAPT~     approach has shown superior technical results with similar functional outcomes while lowering~     procedure time and device costs versus traditional stent retriever as a first line therapy~     approaches~   "
84048|NCT02466880|"~     This study aims to evaluate a culturally appropriate, low cost and sustainable management~     plan for patients with type 2 diabetes mellitus (T2DM). Various randomized controlled trials~     confirmed that T2DM can be delayed with lifestyle intervention and programmes which promote~     improvements in diet, increased physical activity and weight loss. Translation of lifestyle~     intervention to real-life settings however remains a major challenge.~      The investigators therefore propose a diabetes management trial for T2DM patients using~     telemedicine. This project's innovations include the use of information technology to deliver~     messages to the physicians while similarly involving family members of diabetics to manage~     the patient's condition collectively. This creates a sense of well-being, empowering the~     individual as well as the community to be responsible for their own health and well-being~   "
84049|NCT02466867|"~     This is an open label, multi-center, multi-application pharmacokinetic study in pediatric~     subjects with tinea corporis.~   "
84086|NCT02466386|"~     To evaluate the long-term safety of SPD489 administered as a daily morning dose (5, 10, 15,~     20, and 30 mg/day) in preschool children diagnosed with Attention-deficit/Hyperactivity~     Disorder (ADHD). Participants will be enrolled into this study from antecedent study~     SPD489-211 (NCT02402166) or SPD489-347 (NCT03260205) (roll-over participants) or through~     direct enrollment (direct enrolled pariticpants).~   "
84051|NCT02466841|"~     Compression of the ulnar nerve at the elbow (cubital tunnel syndrome) is the second most~     common compressive neuropathy of the upper extremity (carpal tunnel is the most common).~     Patients who fail conservative treatment (activity modification, splinting, medications) are~     offered cubital tunnel release. There are multiple techniques to decompress the ulnar nerve~     at the elbow, but the ideal release has not been determined. These techniques vary from~     simple decompression of the nerve (in-situ release, endoscopic release), to decompressing the~     nerve and moving it anteriorly to take tension off the nerve (subcutaneous transposition,~     sub-fascial transposition, sub muscular transposition), and removing part of the medial~     epicondyle (medial epicondylectomy). Each procedure has purported benefits and also potential~     complications. Simple in-situ release has the benefit of shorter operative times and less~     surgical dissection, however, the nerve may subluxate post-operatively and cause persistent~     pain. Procedures to move the nerve (subcutaneous transposition, sub-fascial transposition,~     sub muscular transposition) prevent subluxation and take tension off the nerve, however, they~     require more dissection, larger incisions, and also partially devascularize the nerve. Medial~     epicondylectomy prevents subluxation and decompresses the nerve, but some patients may have a~     prolonged recovery and persistent pain from removing part of the bone.~      The purpose of this study is to prospective evaluate patients undergoing cubital tunnel~     release according to the standard practice and preference of their surgeon. The investigators~     plan to compare the different techniques at standard post-operative intervals.~   "
84052|NCT02466828|"~     Glioblastoma multiforme (GBM) is the most common primary malignant brain neoplasm in adults.~     Despite recent diagnostic and therapeutic advances, including aggressive surgical resection~     and chemoradiation, the prognosis of GBM has improved only slightly over the past two~     decades, with median survival of approximately 15 months. Tumor hypoxia is a feature of GBM~     that contributes to poor outcome through multiple mechanisms such as 1) overexpression of~     enzymes that play roles in temozolomide resistance, the main chemotherapeutic agent in GBM~     and 2) increase expression of cancer stem cells which are more resistant to radiation.~     Hypoxic tumour regions are associated with higher rates of progression and recurrence.~      In this study the investigators will use an advanced MRI technique called qBOLD to~     non-invasively measure oxygenation in GBM and obtain targeted biopsies. The investigators~     take advantage of physical characteristics of Ferumoxytol (Feraheme®) which is an iron~     supplement, and utilize two recent technical advances not previously used in human tumours to~     quantitatively measure oxygenation in GBM.~      Prior knowledge of hypoxia can assist in prognostication and individualization of treatment~     planning with special focus on hypoxic regions by targeted radiation dose or regimen~     modulation; consideration of more intensive chemotherapy regimens; more aggressive and~     targeted surgical resection and closer short-term clinical and imaging follow-ups.~   "
84053|NCT02466815|"~     The purpose of this study is to assess the relative bioavailability of 2 prototype G-025~     tablets compared with the current G-018 tablet.~   "
84054|NCT02466802|"~     This is a phase 1 study of sildenafil in combination with regorafenib in patients with~     progressive advanced solid tumors. A modified 3+3 dose escalation design will be conducted~     for the dose escalation of the treatment combination: additional patients will be enrolled at~     the MTD until a total of 12 patients have been treated at the MTD.~   "
84055|NCT02466789|"~     The purpose of this study is to improve the investigators ability to diagnose von Willebrand~     Disease (VWD), a common inherited bleeding disorder. This study will look at a new screening~     blood test used to determine if a person has VWD. This new screening blood test can determine~     a diagnosis more rapidly than current blood tests. Also this test could be available at local~     hospital labs rather than require samples to be sent to bigger more specialized labs.~   "
84056|NCT02466776|"~     The purpose of this study is to determine the optimal skin closure technique (staples versus~     subcuticular suture) at the time of cesarean delivery in Class III obese women with body mass~     index (BMI) of >/= 40kg/m2.~   "
84057|NCT02466763|"~     In 1985, the United States Food and Drug Administration (FDA) approved multichannel cochlear~     implants (CIs) for adults with profound hearing loss; and in 1990, implantation was approved~     for children. Since then, this procedure has become the standard of care for patients with~     severe-to-profound sensorineural hearing loss. Successful outcomes are dependent not only on~     extrinsic factors, but also on intrinsic factors that cannot always be modified by the CI~     team. Significant predictive factors for hearing outcomes in patients with CIs have been~     previously reported. These include, but are not limited to, duration of deafness, level of~     preimplant speech recognition, pre/postlingual status, and the coupling of device electrodes.~     Recipient age does not appear to have a significant impact on hearing outcomes in elderly~     candidates.~      Earlier studies have found that, because of its dimensions and proximity to the spiral~     ganglion cells, the scala tympani (ST) is the preferred location for CI electrode placement.~     A number of recent studies have proposed that intraoperative factors may be important~     determinants of electrode location and possibly of audiological outcome. Preliminary reports~     suggest that intracochlear electrode position- specifically, placement within the ST-is~     associated with improved audiological outcomes. Additionally, different surgical techniques~     have been proposed to minimize trauma during electrode insertion and to increase the~     likelihood of placement within the ST - namely round window and anteroinferior cochleostomy~     electrode insertion.~      Currently, the best surgical approach for electrode insertion is highly debated, fueled by a~     lack of strong evidence to support one method over another. While a number of CI centers have~     begun to utilize a round window approach, many large volume centers in the United States and~     world wide continue to routinely employ cochleostomy electrode insertions. With an increasing~     number of patients being implanted with greater degrees of residual hearing, such data will~     become critical towards reducing intracochlear injury and optimizing patient outcomes. To the~     investigators' knowledge, no clinical study has prospectively investigated the relationship~     between surgical insertion technique, intracochlear electrode location, and postoperative~     hearing outcomes. To this end, the investigators are initiating a multicenter prospective~     randomized controlled double-blinded study comparing round window and cochleostomy cochlear~     implant electrode insertion.~   "
84058|NCT02466750|"~     This study is being conducted to collect safety and immunogenicity data for the WEE vaccine,~     TSI-GSD 210. Enrollment in this protocol is offered for personnel who enter areas where this~     virus is used in research or is endemic (an area where this disease process is found to occur~     frequently).~   "
84059|NCT02466737|"~     Although there is no doubt that the presence of lymph node metastases worsens prognosis of a~     patient, unambiguous evidence to support lymph node dissection is still lacking. For many~     solid tumors, the role of lymph node dissection is yet controversial, and may depend on the~     tumor type and the stage of patient presentation for diagnosis. Axillary surgery for breast~     cancer is now considered as staging procedure that does not seem to influence breast cancer~     mortality. Women with breast cancer have benefitted greatly from a series of carefully~     performed randomized controlled trial focusing on axillary surgery. The objective of INSEMA~     is to show that less axillary surgery is better, in that oncological outcomes are the same~     and less surgical intervention will result in fewer surgical complications.~   "
84060|NCT02466724|"~     Colorectal cancer (CRC) is a common and life threatening condition that will affect one in~     thirteen individuals. Colonoscopy is the most commonly used procedure to identify colorectal~     malignancies or precancerous lesions at an earlier stage, which affords an opportunity for~     cure. However, low level of bowel cleanliness hinders polyp detection and therefore can limit~     colonoscopy effectiveness. Historically, the majority of the studies have focused on~     pharmacological factors to optimize bowel preparation quality. Recently, non-pharmacological~     factors have been found to have significant increases in bowel preparation quality. The~     purpose of this study is to evaluate the effectiveness of web-based instructions vs. the~     historical phone/letter instructions given to patients planning to have a colonoscopy.~   "
84061|NCT02466711|"~     The purpose of this study is to evaluate the effects of relamorelin (RM-131) on gastric~     volume, motor and sensory effects in healthy patients.~   "
84062|NCT02466698|"~     Clostridium Difficile infections (CDIs) are treated initially with antibiotic therapy and~     supportive care, with surgical intervention reserved for patients with significant systemic~     toxicity or perforation. Severe CDI may be refractory to medical management and require~     surgical intervention, carrying a mortality of approximately 40%.~      Mortality associated with CDI increases significantly as the severity of the infection~     increases. In patients failing medical management, earlier operation is associated with~     decreased mortality. However, the lack of validated tools to predict the necessity for~     surgical intervention, combined with the significant morbidity associated with total~     colectomy significantly reduces the likelihood of patients receiving early surgical~     intervention. The purpose of the proposed study is to assess the addition of intestinal PEG~     lavage via nasojejunal tube to usual care in the treatment of adult patients with severe CDI~     who have no immediate indication for surgical intervention.~   "
84063|NCT02466685|"~     The goals of this study are to evaluate the efficacy of JNJ-18038683 in an 8 week trial to~     ameliorate the cognitive deficit and reduce residual depressive symptoms in 60 stable bipolar~     outpatients receiving treatment for depression. JNJ-18038683 will be studied and compared~     with placebo as adjunctive treatment to standard pharmacologic treatment for bipolar~     disorder.~   "
84064|NCT02466672|"~     This study will measure the effect of anemia on the outcomes of hospitalized children with~     severe pneumonia.~   "
84065|NCT02466659|"~     To determine the effectiveness of alternate occlusion therapy for the treatment of IXT among~     patients aged 3 to < 11 years old.~   "
84066|NCT02466646|"~     The purpose of this study is to determine whether full-mouth disinfection is effective in the~     initial periodontal treatment of generalized aggressive periodontitis on clinical parameters~     and gingival crevicular fluid interleukin-1β (IL-1β) and interleukin-17 (IL-17) levels~     compared with conventional initial periodontal treatment and full-mouth initial periodontal~     treatment.~      The investigators' hypothesis is to test whether full-mouth disinfection in the initial~     periodontal treatment of generalized aggressive periodontitis enhance the clinical and~     biochemical parameters in comparison to conventional initial periodontal treatment and~     full-mouth initial periodontal treatment.~   "
84067|NCT02466633|"~     To increase the potential for timely detection and treatment of cardiac events, hospitals~     have implemented a number of different cardio-respiratory monitoring methods for at-risk~     patients. The goal of this study is to compare different monitoring methods to determine the~     most efficient method to monitor hospitalized patients - the method that will lead to the~     quickest response to critical heart rhythms. The investigators will then test the efficiency~     of this monitoring method by implementing it in a new patient care unit.~   "
84068|NCT02466620|"~     The purpose of this study is to study the validity, reliability and practicality of the~     different weight estimation methods (parent estimation method, Mercy method, Broselow tape,~     original and update APLS) in Thai children.~   "
84069|NCT02466607|"~     The electroretinogram (ERG) is a diagnostic test that measures the electrical activity~     generated by cells in the retina in response to a light stimulus. Typically, an ERG is~     recorded with white flash when the pupil is dilated. RETeval Visual Diagnostic Device~     (RETeval) generates an array of color flashes, which allows studying whether color flash~     would be a useful diagnostic tool.~      Full pupil dilation is required to obtain a response from the whole retina. However, this~     requirement often limits a patient's flow in the clinic and increases the overall time~     patients spend at the eye practitioner. RETeval provides the possibility of recording ERGs in~     un-dilated pupils therefore making the whole exam easier and shorter. These results need to~     be compared to the classic, fully dilated ERG and evaluated for efficiency.~      The purpose of this research study is to use the RETeval device to measure the eye's~     electrical response and how it changes with different stimuli such as changing flash color or~     pupil dilation.~   "
84070|NCT02466594|"~     This study evaluates the impact of active thermoregulation on free flap microcirculation~     following free flap transfer. Thermoregulation is performed by passive warming, active~     warming (water circulation based device) and active cooling. Changes in microcirculation are~     assessed using combined laser Doppler flowmetry and remission spectroscopy.~   "
84071|NCT02466581|"~     This is an international (Nordic) trial designed to compare the safety and efficacy of active~     conventional therapy (ACT) and three biologic treatments (Certolizumab-pegol, Abatacept or~     Tocilizumab) in subjects with early rheumatoid arthritis (RA). The global aim of this study~     is to assess and compare two alternative de-escalation strategies in patients who achieved~     low disease activity during first-line therapy in the NORD-STAR study.~   "
84072|NCT02466568|"~     The purpose of this study is to find out what effects (good and bad) a tumor vaccine~     (GM.CD40L) used in combination with Nivolumab will have on participants and their cancer.~     Another purpose of the study is to find out the maximum tolerated dose of nivolumab in~     combination with GM.CD40L vaccine. Investigators also want to find out if the combination of~     GM.CD40L and nivolumab can boost the immune system of participants like you, and how their~     immune system reacts, both before and after the treatment.~   "
84087|NCT02466373|"~     This study is developed for assessing the pharmacodynamic and pharmacokinetic properties of~     intravenous (IV) clonidine in critically ill patients on the ICU, and to estimate the optimal~     dosing strategy for IV clonidine.~   "
85217|NCT02451579|"~     A double-blind, placebo controlled study conducted at a single study site. Evaluating the~     role of systemic antihistamine therapy in the reduction of adverse effects associated with~     topical 5-aminolevulinic acid photodynamic therapy.~   "
84073|NCT02466555|"~     The purpose of this study is to investigate the effects of the BEATS Music Therapy Program on~     the self-efficacy, trust, knowledge, and adherence of young adult patients with sickle cell~     disease during transition.~      Primary Hypotheses:~      Compared to baseline, young adult patients with sickle cell disease who receive the music~     therapy interventions will report:~        1. Higher sickle cell self-efficacy as measured by the Sickle Cell Self Efficacy Scale~          (SCSES),~        2. Higher trust in health care providers as measured by the Wake Forest Trust in the~          Medical Profession Scale, and~        3. Higher sickle cell disease knowledge as measured by the Seidman Sickle Cell Knowledge~          Quiz.~      Secondary Hypotheses~      1. Compared to the one year prior to the study period, young adults with sickle cell disease~     who receive the music therapy interventions will have a higher rate of adherence to clinic~     appointments during the one-year study period.~      Additional Questions~        1. Do music therapy interventions influence attendance to scheduled blood transfusions?~        2. Do music therapy interventions influence the rate of hospital utilization as measured by~          Emergency Department visits, Acute Care Clinic visits, and admissions during the study~          period compared to the previous year?~        3. Do music therapy interventions influence adherence to hydroxyurea therapy for patients~          receiving hydroxyurea as measured by change in mean corpuscular volume (MCV) during the~          study period?~        4. Do music therapy interventions influence adherence to iron chelation therapy for~          patients receiving iron chelation therapy as measured by ferritin count during the study~          period?~   "
84074|NCT02466542|"~     This study aims to compare the quality of perioperative analgesia of esmolol in patients~     undergoing mastectomy.~   "
84075|NCT02466529|"~     Spinal muscular atrophy (SMA) is an autosomal recessive disorder characterized by~     degeneration of motor neurons in the spinal cord and caused by mutations of the survival~     motor neuron 1 (SMN1) gene.~      The investigators will conduct a systematic review of the contents and activities collected~     via a comprehensive case report form. Patients who fulfilled diagnostic criteria for SMA type~     1 will be reviewed retrospectively.~   "
84076|NCT02466516|"~     This study will evaluate the safety and tolerability of GS-4997 alone or in combination with~     Simtuzumab (SIM) in adults with Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages~     F2-F3. Participants will be randomized in a 2:2:1:1:1 ratio to 1 of 5 study treatment arms.~   "
84077|NCT02466503|"~     The objective of this pivotal study is to evaluate the relative bioavailability of Synflutide~     HFA 250/25 Inhaler and SeretideTM 250 EvohalerTM in healthy volunteers with charcoal block.~   "
84078|NCT02466490|"~     Fimasartan (FMS) is an AT1 receptor antagonist indicated for once a day administration,~     currently approved for the treatment of essential hypertension in Corea and Mexico. As the~     safety and efficacy of FMS was initially demonstrated in Korea only, it was necessary to~     address the potential for ethnic factors to have an effect on the drug´s efficacy and safety~     in the Mexican population. To address this need, a cohort of 272 Mexican subjects with grades~     1-2 essential hypertension were sequentially treated on a treat to target basis (target:~     sitting Diastolic Blood Pressure (sDBP) <90 mmHg) with 60 mg FMS once a day (8 weeks), either~     120 mg FMS or 60 mg FMS+12.5 mg HCTZ once a day (randomized 4 week treatment period) and 120~     mg FMS once a day (during 12 weeks) for a total treatment period of 24 weeks.~   "
84079|NCT02466477|"~     Evidence exists supporting the ability of genetic variations to influence patient drug~     response and side effects. Previous studies utilizing an open-label design have shown~     significant improvement in major depressive disorder (MDD) patient outcomes following use of~     the GeneSight Psychotropic (GEN) test. The first objective of this trial is to utilize a~     double-blinded, randomized clinical trial design to replicate previous findings of~     improvement in clinical outcomes in MDD subjects whose medication therapy was guided by GEN~     testing. Another objective is to determine the added benefit of Enhanced-GeneSight (E-GEN)~     compared to GEN for the pharmacogenomic guidance of treatment selections. Furthermore, this~     trial intends to develop an evidence-based case for the value of GEN and E-GEN to Canadian~     healthcare payers.~   "
84080|NCT02466464|"~     The purpose of this study is to compare a new treatment for nosebleeds to the treatment that~     has been used for many years.~   "
84081|NCT02466451|"~     Observational longitudinal study in children operated at birth on diaphragmatic hernia and/or~     oesophageal atresia : assessment of lung function parameters; assessment of quality of life~     and cognitive development; assessment of stress parenting and strategies of adaptation.~   "
84082|NCT02466438|"~     Severe infection is one of the main causes of disease in hospitalized children and can be~     deadly. With the lack of novel antibiotics approved in children and the emergence of drug~     resistant bacteria, there is a critical need to optimize dosing of existing antibiotics.~     Piperacillin-tazobactam is an antibiotic frequently used for treatment of severe infection in~     children in Canadian hospitals. To optimize this antibiotic's efficacy despite the rise of~     antibiotic resistance, alternative dosing strategy is commonly used in adults, which consists~     of prolonging the time during which the drug is infused (4 hours instead of 30 min). Children~     clear piperacillin-tazobactam from their bodies at a slower rate than adults, consequently~     extended-infusion strategy cannot be directly extrapolated from adult to children. We believe~     that younger children need piperacillin-tazobactam infusions that are shorter compared to~     adults to achieve appropriate concentrations.~   "
84083|NCT02466425|"~     The study is designed to evaluate the efficacy and safety of SHP465 in the treatment of ADHD~     in children and adolescents (aged 6-17 years). The primary objective of this study is to~     evaluate the efficacy of SHP465 administered as a daily morning dose compared to placebo in~     the treatment of children and adolescents (6-17 years of age inclusive) diagnosed with ADHD.~   "
84084|NCT02466412|"~     The primary objective of this clinical study is to evaluate the pharmacokinetic (PK) profile~     of nicotine (rate and amount of nicotine absorbed) after single use of the Carbon Heated~     Tobacco Product 1.1 Menthol (CHTP 1.1 M), a potential Modified Risk Tobacco Product, compared~     to menthol cigarettes (mCC) in healthy smokers.~   "
84085|NCT02466399|"~     This is an open-label, randomized, multi-center, active-controlled parallel-comparison of~     POLAT-001 to latanoprost ophthalmic solution in patients with ocular hypertension and primary~     open-angle glaucoma.~   "
84486|NCT02461160|"~     The purpose of this study is to characterize the safety, tolerability and plasma~     pharmacokinetic (PK) profile of TAK-915 when administered as single and multiple oral~     suspension doses at escalating dose levels in healthy participants, including elderly~     participants.~   "
84088|NCT02466360|"~     Non-specific chronic lower back pain is a common pathology which is a real public health~     problem. Around 84% of the population could have non-specific chronic lower back pain at~     least once in their lives and 8% of that non-specific lower back pain could become chronical~     (pain that would last at least 3 months). This proportion of patients represents 85% of the~     costs related to this pathology.~      Physical activity practice is involved in medical care for plenty of chronical diseases and~     particularly for chronic lower back pain. In 2003, World Health Organization pointed out the~     poor adhesion of patients with chronical diseases to medical prescriptions and the~     after-effects it could have on illness evolution. Therefore, adhesion to physical activity~     practice for patients with chronic lower back pain is one of the most challenging matters for~     medical teams.~      The aim of this study was to identify the brakes and levers of physical activity practice for~     these patients. Sixteen individual interviews and four focus groups have been carried out on~     patients with chronic lower back pain who were taken care of either by a rachis functional~     restoration program or by primary care.~   "
84089|NCT02466347|"~     The objective of this pivotal study is to evaluate the relative bioavailability of Synflutide~     HFA 250/25 Inhaler and SeretideTM 250 EvohalerTM in healthy volunteers without charcoal~     block.~   "
84090|NCT02466334|"~     It has previously been shown that nitroglycerine induces cluster headache attacks in episodic~     cluster headache patients (ECH patients) in bouts but not in remission phase. Furthermore,~     plasma concentrations of calcitonin gene-related peptide (CGRP) have been shown to be~     significantly higher during, but not before and after, an attack.~      The attack appears around 20-40 min after nitroglycerine infusion with vasodilatation. During~     this latency period preceding the attack, no increase in CGRP plasma concentrations is seen.~     CGRP induces migraine attacks in 65% of migraine patients, and CGRP antagonists as well as~     monoclonal antibodies against CGRP are effective in migraine treatment.~      Based on the above the investigators hypothesize the following:~        1. Provoking ECH patients in bout with CGRP triggers cluster headache attacks~        2. Provoking ECH patients in remission with CGRP does not trigger cluster headache attacks~        3. Provoking chronic cluster headache patients with CGRP triggers cluster headache attacks~          more often than in ECH patients.~   "
84091|NCT02466321|"~     The purpose of this study is to obtain outcomes data on the Anatomical Shoulder™~     Inverse/Reverse System by analysis of standard scoring systems and radiographs.~      Outcome data will be collected using the following standard scoring systems of which summary~     statistics will be provided:~        -  Constant and Murley Score to evaluate clinical parameters such as range of motion,~          power, level of pain and functional ability.~        -  SF-12 Physical and Mental Health Summary Measures (SF12 Questionnaire) comprising of~          twelve questions to assess the subject's physical and mental health status which must be~          answered by the patient.~   "
84092|NCT02466308|"~     ZetrOZ's Ultrasonic Diathermy device (sam(R) Professional System) is intended for use as a~     portable and wearable medical device which, when applied to various areas of the body applies~     Low Intensity Therapeutic Ultrasound (LITUS) to deep tissues. This device is FDA-cleared for~     pain reduction, treatment of muscle spasm and joint contracture, and increasing local~     circulation. This study will look at the use of therapeutic ultrasound to relieve pain and~     enhance tendon extensibility for individuals with tendinopathy over a 6 week time period.~   "
84093|NCT02466295|"~     The purpose of this study is to investigate whether the pressure controlled ventilation can~     reduce gastric insufflation compared to the volume controlled ventilation in patients who~     were mechanically ventilated with the i-gel.~   "
84094|NCT02466282|"~     It is well-known that non-optimal stent implantation associated with under-expansion or~     incomplete strut apposition during percutaneous coronary intervention (PCI) leads to a higher~     incidence of restenosis and stent thrombosis. OCT-guided PCI with metallic stent has~     previously been shown to be safe and feasible, resulting in better clinical outcomes compared~     with angiography-only guided PCI. Everolimus-eluting bioabsorbable vascular scaffold (BVS;~     Abbott Vascular, Santa Clara, CA, USA) was made from a bioabsorbable polylactic acid backbone~     which is coated with a more rapidly absorbed polylactic acid layer that contains and controls~     the release of the antiproliferative drug, everolimus. BVS has a number of proposed~     advantages over current metallic stent technology. These include elimination of chronic~     sources of vessel irritation and inflammation, which can reduce the potential risk of late~     scaffold thrombosis after complete scaffold bioresorption. Although the current generation of~     the Absorb BVS have larger strut thickness of 150 μm compared with 80 μm of strut of Xience~     stent, the acute recoil of the polymeric device was similar to that of metallic stent.~     However, operators tented to use dilating devices less aggressively because of the concerns~     about limitation in elongation-at-break of polylactide. Previous studies reported 20-30% of~     under-expansion or malapposition with BVS, which would increase the risk of adverse events~     including late stent thrombosis. OCT-guidance may improve more optimized scaffold placement~     and also better outcomes. Therefore, investigators will compare OCT guidance and~     angiography-only guidance for PCI with BVS regarding incomplete scaffold apposition and~     neointimal scaffold coverage. Investigators are also going to compare these two strategies~     regarding clinical outcomes with verification of the cut-off value by OCT-acquired uncovered~     scaffold rate.~   "
84095|NCT02466269|"~     A new surgical approach, denoted as the supratemporalis approach, was designed to treat~     diacapitular condylar fractures of the mandibular condyle.This approach prevented facial~     nerve injury and did not increase the frequency of other complications. Therefore, the~     investigators suggest this surgical procedure as a routine and safe approach to diacapitular~     condylar fractures, which can also be applied to temporomandibular joint（TMJ）and to the~     zygomatic arch.~   "
84096|NCT02466256|"~     This randomized clinical trial compares subjective performance during Intraocular lens (IOL)~     implantation, as well as incision enlargement and anterior segment morphology on OCT when IOL~     implantation was performed during microcoaxial phacoemulsification through a 2.2mm incision~     using one of three injectors :~      Manual screw type (Monarch III), Manual plunger type (Royale) and motorised injector~     (Autosert). Further, the investigators also looked at incision integrity by comparing ingress~     of trypan blue from the ocular surface into the anterior chamber.~   "
84097|NCT02466243|"~     The purpose of this study is to evaluate the safety, tolerability and efficacy of JBT-101 in~     adult subjects with skin-predominant, dermatomyositis (DM) that is refractory to at least 3~     months treatment with hydroxychloroquine.~   "
84142|NCT02465658|"~     The presence of co-existence of cervical elongation in women of uterine prolapse may decrease~     the patients' satisfaction of uterine-preservation surgery for uterine prolapse, and~     additional surgery, such as Manchester surgery, may be needed to solve the problem.Thus the~     aim of this study is to investigate the risk factors of co-existence of cervical elongation~     in uterine prolapse.~   "
84098|NCT02466230|"~     This study utilizes resting state fMRI, arterial spin labelling imaging, diffusion tensor~     imaging, structural MR-imaging, and MR-spectroscopy of GABA and Glutamate to probe the~     antidepressant mechanisms of repetitive transcranial magnetic stimulation (rTMS). The above~     imaging modalities will be acquired before and after an open-label 5 week course of rTMS for~     depression in currently depressed individuals with treatment resistant depression. Changes in~     functional, structural, and neurochemical markers will be investigated in rTMS responders and~     nonresponders to elucidate mechanisms of plasticity that correlate with treatment response.~     Additionally, functional, structural, and neurochemical signatures at baseline that correlate~     with subsequent treatment response will be investigated.~   "
84099|NCT02466217|"~     The family of inflammatory/autoimmune systemic diseases (IAD) form a continuum from pure~     inflammatory diseases to pure autoimmune diseases, encompassing a large panel of inflammatory~     diseases with some autoimmune components, and vice versa. Cross phenotyping of patients with~     IAD should be heuristic and help revise the nosography and the understanding of these~     diseases.~   "
84100|NCT02466204|"~     A prospective, randomized, controlled study to explore the efficacy and safety of using~     either corifollitropin alfa 150 mcg or daily recombinant follicle stimulation hormone (FSH)~     300 international unit (IU) for the stimulation treatment of subjects undergoing controlled~     ovarian stimulation prior to IVF.~      The study is designed as a non-inferiority trial. The sample size for this trial of 400~     subjects, in both groups, being treated for one IVF cycle is based upon the primary endpoint~     of the number of oocytes retrieved.~   "
84101|NCT02466191|"~     Pendular nystagmus corresponds to an enduring to and fro eye oscillation without resetting~     quick phases. The most common causes of acquired pendular nystagmus (APN) are multiple~     sclerosis (MS) and focal brainstem lesions (oculopalatal tremor, OPT). Based on~     pathophysiological hypothesis, pharmacological treatments of acquired nystagmus have been~     thoroughly proposed over different publications of cases, series, reviews or expert opinions.~     Acquired pendular nystagmus underwent the most rigorous treatment trials, leading to the~     proposal of gabapentin or memantine as valuable drugs. Whether gabapentin and memantine are~     effective in APN associated with OPT remains unclear, since none of the previous studies has~     evaluated the effect of these medications in a group of OPT patients. However, this is an~     important issue in prospect to a clinical use of these medications. In the current study, the~     investigators aim is to evaluate the effect of gabapentin and memantine on the mean velocity,~     amplitude and frequency of pendular nystagmus, as well as on visual acuity and~     vision-specific health-related quality of life score, in a group of OPT patients~   "
84102|NCT02466178|"~     The purpose of this study is to evaluate the ability of the Serene RF System to effectively~     improve the appearance of dynamic glabellar lines and sustain the effect for a minimum of 3~     months.~   "
84103|NCT02466165|"~     Multiple Sclerosis (MS) is the most common chronic inflammatory neurological disorder in~     young adults. Due to heterogeneous symptoms, MS patients are often more inactive than healthy~     controls, resulting in an inactivity related physiological profile. In healthy people,~     physical inactivity can contribute to the development of an increased cardiometabolic risk~     state including the combined presence of cardiovascular risk factors (increased cholesterol,~     elevated blood pressure, body fat, glucose intolerance/insulin resistance, inflammation and~     reduced heart function/autonomic control). In other populations, these secondary health~     complications can be, in part, reduced by physical exercise, which is often used as the~     primary treatment strategy. Since the impact of exercise on cardiovascular risk factors in MS~     is unknown the present project first aims to explore this in a pilot trial and a controlled~     research setting (during 12 weeks). A better understanding of the above described risk~     factors and underlying physiological mechanisms will reduce the incidence of preventable~     comorbidities in MS and will further improve the multidisciplinary treatment of MS patients~     and MS rehabilitation in particular. Interestingly, the investigators already reported an~     elevated prevalence of impaired glucose tolerance in MS, but it is not clear whether the~     cardiometabolic state in MS is also impaired. Therefore, in a second part, the researchers~     will explore whether MS patients present a higher risk to develop cardiovascular diseases, as~     measured by the assessment of various cardiovascular risk factors, compared to healthy~     controls.~   "
84104|NCT02466152|"~     This study will assess the systemic exposure and pharmacokinetic parameters of GSK2894512~     following twice daily topical administration of 1% and 2% cream in adult subjects with AD,~     and will provide information about the systemic safety as well as local safety and~     tolerability following twice daily application to up to 35% body surface area (BSA) of~     affected skin of subjects with AD. It will be an open-label, sequential study consisting of 2~     cohorts. A cohort of 6 subjects (Cohort 1) will apply GSK2894512 (cream, 2%) to affected skin~     on an area ranging from 15 to 35% of the total BSA for 20 days plus a final dose on Day 21.~     Cohort 2 will consist of 6 subjects that will apply 1% cream. Cohort 2 will follow the same~     procedures as Cohort 1.~   "
84105|NCT02466139|"~     The investigators conduct a prospective observational study on consecutive patients being~     admitted to a tertiary care-centre with infective endocarditis. The investigators' primary~     aim is to identify baseline clincal, laboratory and microbiological predictors of in-hospital~     events, mortality and 6-month mortality.~   "
84106|NCT02466126|"~     The purpose of this study is to determine the effectiveness of a brief cognitive behavioral~     therapy (bCBT) intervention for Veterans with depression delivered by mental health providers~     located at VA Community Based Outpatient Clinics (CBOC's) associated with the Houston and~     Oklahoma City VAMCs.~   "
84107|NCT02466113|"~     Whether patients with stage II colon cancer should receive adjuvant chemotherapy or not is~     still on debate.MicroRNA(miRNA) is a promising tool. Investigators invented a tool consisting~     of 6 miRNA(miR-21、miR-20a-5p、miR-103a-3p、miR-106b-5p、miR-143-5p and miR-215) that was~     effective to identify one should accept adjuvant chemotherapy or not. Here investigators~     randomly assign patients to be assessed by classical pathological features or the miRNA tool~     of determining who should accept chemotherapy. Disease free survival and overall survival are~     the end points of observation.~   "
84162|NCT02465398|"~     The purpose of this study is to obtain outcomes data on the Anatomical Shoulder Fracture~     System by analysis of standard scoring systems and radiographs.~      Outcome data will be collected using the following standard scoring systems:~        -  Constant and Murley Score~        -  Oxford Shoulder Score~        -  EQ-5D (EuroQol)~   "
84108|NCT02466100|"~     This study proposes to evaluate, among adults with advanced heart failure (HF) and their~     health care providers, the effects of a communication intervention designed to improve~     patient-provider communication about goals of care (GoC). Patient activated GoC conversations~     can result in providers' better understanding their patients' preferences for end-of-life~     care. GoC conversations that occur over time may allow patients and providers to consider a~     wider range of options earlier in the HF illness trajectory. Preliminary data suggests that~     the proposed GoC intervention increases the occurrence and quality of patient-provider~     communication about end-of-life care for advanced COPD. The proposed study will test the~     effects of the GoC intervention compared to usual care, using a randomized, 2-group (N = 80,~     n = 40/arm), repeated-measures design. Measures will be taken at a patient's baseline study~     entry and after the next scheduled clinic visit. Specific Aim 1 is to evaluate change in~     number of GoC conversations between patient and provider between the two groups. Specific Aim~     2 is to examine whether the intervention increases patient quality of life, referrals to~     palliative care, advance care planning, decreases depression and anxiety. Specific Aim 3 is~     to describe the feasibility, acceptability, perceived benefits, burden, and implementation~     success of the intervention in the heart failure clinic setting. Patients will be randomized~     to the GoC intervention or to receive usual care. Patients in the GoC intervention group,~     telephone coaching by a research nurse to help patients role-play talking with their HF~     providers. Both patients and their providers, will be provided with summaries of~     individualized, patient-centered information about patient preferences for communicating~     about end-of-life care and patient self-identified barriers to and facilitators of~     communication about end-of-life care with tips on how to initiate goals of care discussions.~     Providers of patients in the intervention group will also be provided with patient-specific~     prognostic information based on the Seattle Heart Failure Model. The GoC intervention will be~     tested in a real-world clinic setting. This intervention is expected to be relatively~     cost-effective and easily translated into general cardiology practice in the future. The~     study is expected to make significant contributions to provision of earlier access to~     palliative care in the advanced HF disease trajectory.~   "
84109|NCT02466087|"~     The objective of this project is to test the hypothesis that magnesium supplementation will~     decrease depressive symptoms in adults.~      This study takes place over 12 consecutive weeks. While the investigators will follow the~     volunteers for the full 12 weeks volunteers will only take magnesium supplements for 6~     consecutive weeks. Volunteers will be randomly assigned to start the supplement at week 1 or~     week 7. Volunteers will take two supplement two times a day for a total of 248 mg elemental~     magnesium daily in the form of magnesium chloride. This amount of magnesium is less than the~     tolerable upper limit of 350 mg per day. The supplements will be provided. Volunteers will be~     asked to maintain their normal diet for the 12 weeks of the study.~      The primary outcome measure is the PHQ-9 questionnaire, a validated measure of depression.~     Secondary measures include the GAD-7 for Anxiety and side effects.~   "
84110|NCT02466074|"~     This study will evaluate how improved cerebral blood flow affects the way in which newly~     formed MS lesions evolve and whether tissue repair is improved. Patients with multiple~     sclerosis (MS) will be treated with acetazolamide in daily divided doses and obtain MRI to~     determine how much and in which regions of the brain cerebral perfusion improves as well as~     the extent to which tissue integrity is improved in these areas.~   "
84111|NCT02466061|"~     This randomized, controlled study evaluates the efficacy of weigh loss interventions in~     endometrial cancer survivors, using novel technology-based weight loss platforms. This is a~     multi-site, pilot feasibility study which will provide preliminary data to support a larger~     NIH funded, mult-center trial.~   "
84112|NCT02466048|"~     This study was designed to investigate the safety and efficacy of SurgiFill™, a bone grafting~     material, in patients with spinal fusion.~   "
84113|NCT02466035|"~     Lactobacillus GG (LGG) is able to exert long lasting effects in children with atopic~     disorders. Nutramigen LGG accelerates tolerance acquisition in infants with cow's milk~     allergy. The mechanisms of these effects are still largely undefined. The effect of LGG could~     be related at least in part by the immunoregulatory role played by LGG. This probiotic can~     balance the generation of cytokines possibly involved in IgE- or non-IgE-mediated cow's milk~     allergy Interleulkin (IL)-4, IL-5, IL-10, IFN-γ , TGF-β, and TNF-Υ), which can contribute to~     modulation of inﬂammatory processes. The investigators have demonstrated that children with~     IgE-mediated CMA produce significantly higher level of IL-4 and IL-13 in response to cow's~     milk protein, and that tolerance is associated with a marked reduction of IL-13 production~     and a concomitant increased frequency of IFN-γ releasing cells.~      Epigenetics studies the heritable (and potentially reversible) changes of the genome~     inherited from one cell generation to the next which alter gene expression but do not involve~     changes in primary DNA sequences, highlighting the complexity of the inter-relationship~     between genetics and nutrition. There are three distinct, but closely interacting, epigenetic~     mechanisms (histone acetylation, DNA methylation, and non-coding microRNAs) that are~     responsible for modifying the expression of critical genes associated with physiologic and~     pathologic processes. The profile of epigenetic modifications associated with Th lineage~     commitment, coupled with the sensitivity of the early developmental period, has led to~     speculation that factors that disrupt these pathways may increase the risk of allergic~     diseases. Specifically, effects on DNA methylation and endogenous histone deacetylase~     inhibitors acting on specific pathways (Th1 and T regulatory cell differentiation) may favour~     Th2-associated allergic differentiation. MicroRNAs are another structural components of an~     epigenetic mechanism of post-transcriptional regulation of messenger RNA translation. It has~     been recently identified a specific Th2-associated microRNA (miR-21) that is critical for the~     regulation of Th cell polarization. It has been previously demonstrated an inverse DNA~     methylation pattern of cytokines involved in Th2 response (IL-4, IL-5) compared with~     cytokines involved in Th1 response (IL-10, INF- y) in children with CMA acquiring oral~     tolerance, with the most pronounced effects in those treated with Nutramigen LGG. The current~     study will prospectively evaluate the effect of Nutramigen LGG and other commercially~     available hypoallergenic formulas on epigenetic mechanisms that may be related to tolerance~     acquisition.~   "
84114|NCT02466022|"~     Dexmedetomidine has demonstrated benefits both in sedation, and post-operative pain control,~     with less respiratory depression than other common sedatives. Traditionally, dexmedetomidine~     has been used with a large loading dose and infusion, which has been known to cause~     dose-dependent negative side-effects (Abdallah et al., 2013). Single dose dexmedetomidine~     produces less negative side-effects, but still effective sedation and reduced post-operative~     pain (Jung et al., 2013). There is evidence for its benefits with general anesthesia but only~     a few studies exist investigating its benefits when administered for sedation purposes with~     spinal anesthesia, and no studies primarily examine post-operative opioid consumption. The~     investigators hypothesize that single dose dexmedetomidine for procedural sedation will~     reduce opioid consumption after total knee arthroplasty (TKA).~   "
84115|NCT02466009|"~     The purpose of the study is to measure high grade (3-5) toxicity of regorafenib and to~     monitor the impact of treatment with regorafenib on the quality of life in older adults with~     metastatic colorectal cancer.~   "
84116|NCT02465996|"~     Functional dyspepsia might have impaired gastric mucosal dysfunction and Puyuanhewei may be~     helpful to improve the symptoms of FD.~   "
84117|NCT02465983|"~     This is a study in which pancreatic cancer patients receive a combination therapy with~     CART-meso cells and CART19 cells administered at 3 days after one dose of cyclophosphamide.~     CART-meso cells are patients' own T cells that were modified in the laboratory to express a~     receptor specific to the mesothelin protein. CART19 cells are patients' own T cells that were~     modified in the laboratory to express a receptor specific to a protein called CD19. The CD19~     protein is expressed on white blood B cells. CART19 cells are expected to attack the B cells~     and impede the antibody response against CART-meso cells. The investigators hypothesize that~     this combination therapy may prolong the duration of CART-meso cells in the body.~     Additionally, one dose of cyclophosphamide may enhance engraftment and persistence of CART~     cells.~   "
84118|NCT02465970|"~     Drug-resistant partial epilepsy has a heavy impact on quality of life and sometimes on life~     expectancy itself. Only a minority of patients may benefit from a curative epilepsy surgery.~     Neurostimulation, which can be an effective add-on treatment, is currently mainly represented~     by vagus nervus stimulation. Transcranial direct current stimulation, a non -invasive~     technique already used in other areas of neurology, may be efficient on some partial~     epilepsies, in particular through the individual configuration of stimulation, made possible~     by recent technological advances.~      Main goal : To study the effect of transcranial electrical stimulation on the frequency of~     seizures in patients with drug-resistant partial epilepsy.~      Hypothesis : Reduction of 50% or more in the frequency of occurrence of seizures within 24~     hours following an individually configured TDCS session: responders in real TDCS vs placebo~     stimulation.~   "
84119|NCT02465957|"~     Phase II study to determine the effects of aNK infusions in combination with ALT-803 in~     patients with stage III (IIIB) or stage (IV) merkel cell carcinoma (MCC).~   "
84120|NCT02465944|"~     This study will be conducted to evaluate the safety, tolerability and efficacy of~     intravenously administered FFP104 or placebo over 15 days (3 total doses) in subjects with~     moderate to severely active Crohn's Disease~   "
84121|NCT02465931|"~     The Decisional Capacity and Informed Consent in Fragile X Syndrome (FXS) project is for the~     Eunice Kennedy Shriver National Institute of Child Health & Human Development,~     1R01HD071987-01A1, and will provide the first comprehensive description of decisional~     capacity of individuals with FXS; identify individual, family, and experiential factors~     associated with variability in decisional capacity; determine the validity of caregiver and~     expert ratings; and develop evidence-based guidelines for categorizing decisional capacity of~     individuals with FXS. RTI will develop a methodologically rigorous and conceptually grounded~     decision aid using digital technology to enhance participation of individuals with FXS in the~     consent process.~   "
84122|NCT02465918|"~     Motor cortex stimulation (MCS) is a form of brain stimulation for patients with neuropathic~     pain not responsive to medication. An electrode is placed on the surface of the brain and~     connected to a programmable battery in the chest.~      The strength of stimulation can be individually adjusted by changing the voltage of~     stimulation. A too high voltage will produce side effects (e.g. seizures) while a too low~     voltage will not provide pain control.~      The aim of this study is to analyze the optimal stimulation timing parameters in patients~     already implanted with MCS and have received good pain relief. The investigators wish to~     cyclize on/off MCS in order to save the battery life of the stimulator and also decrease~     stimulus habituation. The investigators hope to determine these timing parameters while~     maintaining optimal pain relief.~   "
84123|NCT02465905|"~     Prospective study Main objective: to evaluate the efficiency and the security of two~     protocols of immunotherapy (raw milk versus heated milk) in a cohort of children with~     persistent Immunoglobulin E (IgE) mediated CMA (IgE-CMA).~      Secondary objectives: to determinate if the enumeration of casein-specific IL-4- and~     IL-13-secreting T cells could be a valuable biomarker of successful immunotherapy.~   "
84124|NCT02465892|"~     This study aims to explore whether cancer patients can benefit from completing the~     Pillars4Life online coping program. This randomized control trial will have half its subject~     completing the program and the other half receiving standard care in order to measure whether~     the program is beneficial in dealing with stress, anxiety, and particularly chronic pain that~     often accompany a cancer diagnosis.~   "
84125|NCT02465879|"~     There is accumulating evidence that early treatment leads to better outcomes for patients~     with inflammatory arthritis (IA). Triage, which is the process of identifying the urgency of~     a patient's disease state efficiently and correctly, may facilitate early referral to a~     rheumatologist. Several studies have suggested that placing allied health professionals~     (occupational therapists, physical therapists, nurses, etc.) in a triage roll may reduce wait~     time for patients with suspected IA. The goal of this investigation will be to demonstrate~     the system-level impact of an Arthritis Society extended role occupational therapist (OT) or~     physical therapist (PT) working in a triage role in improving access to rheumatologists for~     people with IA. In this study two groups will be observed: intervention and usual care as~     determined by historical chart review. Wait times will be compared between both groups.~   "
84126|NCT02465866|"~     This study will compare the relative bioavailability of hydrocodone, acetaminophen, and~     promethazine in CL-108 (hydrocodone 7.5mg/ acetaminophen 325 mg/ promethazine 12.5 mg)~     manufactured by Charleston Laboratories, Inc. to hydrocodone in Vicoprofen (hydrocodone 7.5~     mg /ibuprofen 200 mg), promethazine 12.5 mg, and acetaminophen in Ultracet (tramadol HCl 37.5~     mg/acetaminophen 325 mg) under fasted and fed conditions.~   "
84127|NCT02465853|"~     Hemiplegic shoulder pain (HSP) is one of most complications after stroke. HSP would impede~     rehabilitation programs and the motor recovery of affected upper extremity. HSP was~     associated with impaired daily life activities and prolong hospital stay after stroke.~     Therefore, effective managements is important in stroke patients with HSP. Rotator cuffs~     injuries are related to HSP. Clinically, hyaluronic acid (HA) is used for rotator cuff~     injuries. Previous researchers reported that HA could provide pain relief, improved motion,~     and increased daily activities. In this study, fifty subacute stoke patients will be~     enrolled. These patients will be allocated into group A and B randomly. The patients in group~     A received HA injection while patients in group B received normal saline injection. Patients~     from both groups received injection for 3 times each on the 1st, 2nd, 3rd week. All the~     patients will still receive rehabilitation programs of physical therapy and occupational~     therapy. Each patient will receive physical, sonographic examinations, and stroke Specific~     Quality of Life Scale (SSQOL). The aims of this study are to investigate the benefits of HA~     injection on pain relief, motor function recovery, and life quality in subacute stroke~     patients with HSP before and after HA injection.~   "
84143|NCT02465645|"~     After successful screening of patients based on inclusion criteria, we will measure the~     baseline Hepatic Venous Pressure Gradient. At day 1 patients will undergo complete blood~     investigation including complete haemogram, kidney function test, liver function test,~     prothrombin time, AFP (Alfa Feto Protein) level, chest x ray, ultrasonography, fibroscan.~     Routine complete physical examination will be done.~   "
84670|NCT02458768|"~     The objective of this study was to demonstrate the non-inferiority of IVFM HP Inj. by~     evaluating its efficacy versus Menopur® Inj. in infertility women undergoing the in vitro~     fertilization and embryo transfer (IVF-ET) among the assisted reproductive technologies.~   "
84128|NCT02465840|"~     Hand injury is one of common occupational or traumatic injury at outpatient clinic of~     rehabilitation department. The motor or sensory deficits after hand trauma including bony~     fracture,tendon / nerve injury, joint stiffness, motion restriction, sensory impairment, or~     pain lead to impaired upper extremity function, ability for daily activity, or quality of~     life. Rehabilitation is a kind of therapy for disability after hand trauma. It could provide~     pain control, improvement of joint motion, stiffness reduction, preventing secondary trauma.~     The investigators consider that there are some deficits in hand function and range of motion,~     pain after injury, and some attenuation of brain functional MRI (fMRI) for hand motor~     control. Therefore, optimal and early intervention of rehabilitation programs may have some~     benefits for their hand functional outcome and improve the brain activities in fMRI images~     for the hand motor control.~      The aims of this study are to compare the differences in hand motor control area of brain~     functional MRI (fMRI) between normal subjects and hand injury patients before treatment and~     to investigate the improvement in brain fMRI activity and functional outcome after early~     rehabilitation in hand injury patients.~      The investigators will collect 40 patients with hand trauma after operation and 10 normal~     subjects in this study. The 10 normal subjects were allocated in the control group. These 40~     patients were randomly divided into 2 experimental groups: 20 patients in group A and 20~     patients in group B.~      In group A and B, the patients will perform immobilization and Kleinert programs~     respectively. All patients will perform rehabilitation regimen with 2-3 sessions per week for~     3-6 months. Before and after rehabilitation, all patients will receive physical examinations,~     brain fMRI, and DASH questionnaire for daily activity.~   "
84129|NCT02465827|"~     The investigators aimed to evaluate the efficacy of selective low volume ultrasound-guided~     blockades of the saphenous and obturator nerves on dynamic and rest pain 24-hours~     post-operatively for patients undergoing unilateral primary total knee arthroplasty.~   "
84130|NCT02465814|"~     The study is performed to assess the efficacy of Vilaprisan (BAY1002670) in patients with~     uterine fibroids compared to placebo and ulipristal. It is also aimed to evaluate the safety~     of vilaprisan in subjects with uterine fibroids. Further, data on population pharmacokinetic~     (PK)/ pharmacodynamic (PD) relationship for vilaprisan in subjects with uterine fibroids will~     be supplemented.~   "
84131|NCT02465801|"~     The purpose of this study is to evaluate the dosages of recombinant human serum~     albumin/granulocyte colony-stimulating factor fusion protein by injection for preventing~     neutrophilic granulocytopenia among chemotherapy patients.~      Conduct Pharmacokinetics (PK) study on recombinant human serum albumin/granulocyte~     colony-stimulating factor fusion protein with recombinant human granulocyte~     colony-stimulating factor injection as a control.~   "
84132|NCT02465788|"~     The objective of this post marketing study is to further explore a variety of treatment~     parameters in order to optimize the optical (laser) and electrical (RF) treatments over the~     various skin types, when using a combination 755 nm alexandrite laser together with a bipolar~     RF energy system, for the purpose of hair reduction.~   "
84133|NCT02465775|"~     Prospective, blinded, one arm, baseline-controlled clinical study for the evaluation the~     performance of the UltraShape treatment for non-invasive fat reduction by compare control and~     treated flanks.~      Study subjects will undergo UltraShape treatments on one randomized flank using the~     U-Sculpt/VDF Transducer. The second flank will not be treated (control). Both flanks (treated~     and control) will be compared to baseline, as well as, one to each other~   "
84134|NCT02465762|"~     Prospective, blinded, one arm, baseline-controlled clinical study for the evaluation of the~     UltraShape treatment for non-invasive fat and circumference reduction.~      Study subjects will undergo UltraShape treatments on the flanks area using the U-Sculpt/VDF~     Transducer - 60 subjects.~   "
84135|NCT02465749|"~     The purpose of this study is to investigate the role of continuous oxygen therapy combined~     with blue light deprivation in prevention and control of retinitis pigmentosa, in order to~     find a new strategy of treatment for retinitis pigmentosa.~   "
84136|NCT02465736|"~     The primary objective is to compare docetaxel plus cisplatin (DP) versus vinorelbine plus~     cisplatin (NP) in neoadjuvant chemoradiotherapy, in terms of the overall survival and~     toxicity in patients with Stage IIB or III squamous cell esophageal carcinoma.~   "
84137|NCT02465723|"~     The purpose of this study is to find out if special blood tests and imaging scans can help~     evaluate the effects of the radiation the patient receives as part of standard treatment. The~     patient will undergo either stereotactic or conventional radiation treatment as determined by~     the treating doctor. Previous evidence suggests that blood flow to tumors is affected by the~     amount (dose) of radiation that it receives. This effect may be seen as soon as 1-2 hours~     after the radiation is given. This study will evaluate if these changes can be seen and~     measured by performing a special type of scan called Intravoxel Incoherent Motion (IVIM)~     diffusion-weighted Magnetic Resonance Imaging (MRI) and a blood test. IVIM MRI is a research~     exam which is similar to a standard MRI exam, with only a slight difference in the technical~     parameters used to acquire the images.~   "
84138|NCT02465710|"~     The issue of whether utilizing the mesh in the surgical treatment of pelvic organ prolapse~     remained undetermined.Thus, the aim of this study is to analyze clinical outcome of women who~     underwent pelvic organ prolapse surgeries with and without mesh implantation in the~     Department of Obstetrics & Gynecology of National Taiwan University Hospital.~   "
84139|NCT02465697|"~     Borderline Personality Disorder (BPD), a prevalent psychiatric disorder found in~     approximately 2% to 6% of the population and 20% of hospitalized psychiatric patients, has~     proven quite treatment resistant. This study is designed to determine whether patients with~     BPD can be trained to improve their ability to regulate their emotions and whether this leads~     to changes in how their brans regulate emotion.~   "
84140|NCT02465684|"~     There is obviously a lack of evidence regarding the risk-benefit ratio of a thigh tourniquet~     in unicondylar knee arthroplasty (UKA). This refers to many possible outcome criteria like~     operating time, blood loss, quality of prosthesis fixation in the bone, adverse events,~     radiographic result, clinical score outcome, easy of rehabilitation etc. It is not~     appropriate to rely on findings from the field of total knee arthroplasty.~      It is the aim of the current study, to clarify the role of a thigh tourniquet during UKA with~     regard to component fixation quality, component positioning and sizing, clinical outcome and~     rehabilitation process.~      Patients scheduled for routine UKA implantation due to osteoarthritis or osteonecrosis in the~     medial compartment will be considered for participation.~      Patients are then randomized for surgery with or without tourniquet. After an anteromedial~     Quad-Sparing approach the UKA procedure itself is then carried out, as suggested by the~     manufacturer. For both groups puls lavage and meticulous drying is applied before cementing.~      The following outcome parameters are assessed: 1)radiographic cement mantle thickness,~     2)component position & sizing, 3)diolucencies, 4)score outcome and 5)parameters of early~     Rehab.~   "
84141|NCT02465671|"~     The current study was designed to investigate the change of plasma thrombospondin-1 levels~     and assess the prognostic predictive effect of plasma thrombospondin-1 levels in the patients~     with acute intracerebral hemorrhage.~   "
84147|NCT02465593|"~     This phase Ib/II study is a prospective, open-label, single arm, nonrandomized study of~     PEP503(radio-enhancer).~      There are 2 portions in this study.~        -  Escalation phase (Part Ib): A 3 + 3 dose escalation study design will be adopted in this~          phase to identify the recommended injection volume of PEP503 for intratumor injection.~        -  Expansion phase (Part II): Following the confirmation of the recommended volume of~          intratumor injection, 18 additional patients will be enrolled at the recommended volume~          level to evaluate for efficacy.~   "
84148|NCT02465580|"~     Dysfunction of regulatory T (Treg) cells has been detected in diverse autoimmune diseases,~     which can be promoted by interleukin-2 (IL-2). In a previous small sample trail performed by~     the investigator's group, the investigators found that the Low-dose IL-2 was effective and~     well tolerated in active SLE, and the effect was associated with selective modulation of CD4+~     T cell subsets.~      This clinical study will confirm the efficacy and safety of low dose IL-2 treatment in SLE.~      The investigators perform a single-centre, double-blind pilot trial with hrIL-2 in SLE.The~     investigators evaluate the effectiveness and safeness of low-dose hrIL-2 for Systemic lupus~     erythematosus by randomized controlled study (hrIL-2 (N = 30) versus placebo group (N = 30)).~   "
84149|NCT02465567|"~     This is a randomized, double-blind, multi-center, parallel-group study to assess the efficacy~     and safety of PT010 relative to PT003 and PT009 on COPD exacerbations subjects with moderate~     to very severe COPD.~   "
84150|NCT02465554|"~     The purpose of this study is to develop new approaches for screening astronauts for~     cardiovascular risk during deep space missions.~   "
84151|NCT02465541|"~     This randomized clinical trial studies how well gentle yoga and dietary counseling lifestyle~     change effects physical function and quality of life of endometrial cancer survivors. Gentle~     yoga and dietary counseling may help improve physical function and quality of life for stage~     I-II endometrial cancer survivors.~   "
84152|NCT02465528|"~     This is Proof-of-Concept (POC) study to assess the preliminary antitumor activity and safety~     and tolerablity using ceritinib (LDK378) in the treatment of life threatening tumors that are~     characterized by ALK genetic alteration (and/or overexpression in some diseases).~   "
84153|NCT02465515|"~     Albiglutide is an analogue of glucagon-like peptide-1 (GLP-1), used to treat type 2 diabetes~     This study will test whether albiglutide affects the occurrence of major cardiovascular~     events such as heart attacks or strokes and other important medical outcomes in persons with~     type 2 diabetes, when used alone or added to other diabetes treatments.~   "
84154|NCT02465502|"~     To determine the efficacy (as measured by progression-free survival [PFS] rate at 8 weeks) of~     regorafenib in subjects with metastatic colorectal cancer (CRC) whose disease is refractory~     to standard therapies and who were never exposed to antiangiogenic therapy.~   "
84155|NCT02465489|"~     The purpose of this study is to look at the pharmacokinetics of a new formulation of~     deferiprone (deferiprone extended release tablets) under fed and fasting conditions.~   "
84156|NCT02465476|"~     The investigators want to demonstrate that a new organization with telemedicine could~     rationalize the treatment pathway of patient suffering from rare skin disease. A diagnosis~     and a personalised treatment pathway could be performed before the consultation in the~     hospital.~   "
84157|NCT02465463|"~     Clostridium difficile infection (CDI) has increased worldwide in both frequency and severity.~     It is the leading cause of hospital acquired infection in developed countries and has been~     associated with at least 14,000 deaths per year in the United States. With 3 million cases/~     year, the annual cost for treating the infection is exceeding 3 billion dollars. It can also~     have a profound negative impact on quality of life.~      The investigators believe that patients who are at high risk of relapse after a first CDI~     episode would benefit from early fecal microbial transplant (FMT). The proposed study will~     produce preliminary data regarding safety and efficacy and potential for cost effectiveness~     for the use of early fecal transplant in those patients with their first episode of~     non-refractory CDI who are predicted to have a high rate of recurrence based on previously~     published risk factors. The investigators will be better prepared to test the efficacy of~     this approach in a future multicenter clinical trial in a randomized controlled fashion.~      The purpose of this study is to compare the effectiveness and safety of early fecal~     transplant using donor stool from a healthy person in a group of patients who are diagnosed~     with their first episode of Clostridium difficile infection and are predicted to have a high~     chance of the infection returning against a similar group of patients who receive current~     standard of care for treatment of C.difficile.~      The investigators hypothesize:~        -  that clinical remission rates at 12 weeks as noted by absence of clinical symptoms~          and/or negative C.difficile stool polymerase chain reaction (PCR) will be greater in the~          experimental arm compared to the control arm~        -  that patients in the experimental group will have a low microbial diversity prior to FMT~          but will exhibit a high microbial diversity after the FMT that resembles the respective~          donor~        -  that the microbial diversity will be diminished in both groups at the time of~          enrollment, but the experimental group will exhibit a higher microbial diversity~          compared to the control population at 12 weeks~        -  that patients in both groups will exhibit poor quality of life at the time of~          enrollment, however, the experimental group will demonstrate higher quality of life~          compared to the control group at follow up after completion of treatment~        -  that costs incurred by the experimental group will be less than the control group~   "
84158|NCT02465450|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and~     efficacy of JBT-101 in adult subjects with cystic fibrosis (CF).~   "
84159|NCT02465437|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and~     efficacy of JBT-101 in adult subjects with diffuse cutaneous systemic sclerosis.~   "
84160|NCT02465424|"~     The purpose of this study is to determine which Health Related Quality of Life (HRQoL) tools~     patients with medullary thyroid cancer (MTC) find most helpful. The study will compare a~     generic cancer QoL tool with those developed for thyroid cancer patients and neuroendocrine~     tumour (NET) patients. The study will also evaluate clinicians' opinions on the clinical~     usefulness of the QoL tools.~   "
84161|NCT02465411|"~     A keystone in preventing diabetic complications in patients with type 1 diabetes is good~     glycaemic control. Frequent self-measurements of blood glucose (SMBG) levels have been an~     essential part of insulin dosing before meals. However, in recent years continuous glucose~     monitoring (CGM) has become a treatment option to inform the patient when glucose levels may~     be too high or low.~      In some countries, including Sweden, CGM is reimbursed only when combined with continuous~     subcutaneous insulin infusions (CSII) in patients with very poor glycaemic control or a~     history of repeated severe hypoglycaemia in adults with type 1 diabetes. This is based on~     existing clinical trial data showing a beneficial effect on HbA1c when CGM is combined with~     CSII. However, despite the fact that the majority of adults with type 1 diabetes are treated~     with multiple daily insulin injections (MDI), studies on the effect of CGM in patients with~     type 1 diabetes treated with MDI are sparse. Therefore, the investigators initiated the~     CGMMDI trial, an ongoing, cross-over clinical trial including 161 MDI patients receiving CGM~     over 6 months, followed by conventional therapy over six months, with a four-month wash-out~     period in-between treatment. Evaluations include glycaemic control, hypoglycaemia, quality of~     life, fear of hypoglycaemia, treatment satisfaction, physical activity, and safety.~      From a research or regulatory standpoint, long-term data on treatment effects are expected to~     a greater extent today than in previous years, due to various reasons, e.g., to evaluate any~     sustained beneficial effects over time, or long-term patient safety. Accordingly, follow-up~     of treatment in an extension phase after randomized diabetes trials have become more common~     over time, especially where many novel glucose-lowering treatments are concerned. Therefore,~     the aim of the current study is to evaluate long-term effects of CGM in patients with type 1~     diabetes treated with MDI. Patients who consent in an extension phase over 1 year of the~     CGMMDI trial will receive CGM, and evaluations will be performed on sustained glycaemic~     control effects, hypoglycaemia, glycaemic variability, quality of life, fear of~     hypoglycaemia, treatment satisfaction, physical activity, and safety.~   "
84163|NCT02465385|"~     Video capsule endoscopy is an important procedure that can be used by doctors to find~     abnormalities in the small intestine, especially those that can cause bleeding. The procedure~     uses a tiny wireless camera to take pictures of the digestive tract. The camera sits inside a~     vitamin-sized capsule that a person can swallow. As the capsule travels through the digestive~     tract, the camera takes thousands of pictures that are transmitted to a recorder worn on a~     belt around a person's waist or over his/her shoulder. However, abnormalities can be missed~     partly because the normal dark liquids present in the intestine can prevent abnormalities~     from being recorded, hiding them from the physician who reviews the video.~      The current method used to clear these dark liquids from your small intestine is to follow a~     clear liquid diet and drink approximately 2 quarts of polyethylene glycol (Golytely®) the day~     before the video endoscopy and take simethicone (a medication used to treat symptoms of gas~     such as uncomfortable or painful pressure, fullness, and bloating) the morning of the test.~      Some of the current preparations to clear these dark liquids are not able to entirely prevent~     abnormalities from being missed and most have an unpleasant taste or involve drinking a lot~     of fluid.~      Linaclotide (Linzess®) is a medication approved by the Food and Drug Administration (FDA) for~     the treatment of constipation and irritable bowel syndrome. It is not approved by the FDA for~     use as an aid for clearing dark liquid from the small intestine prior to a video endoscopy.~      A recent presentation at a medical meeting proposed using one-dose of linaclotide (Linzess®)~     to improve cleansing of the small intestine for capsule endoscopy preparation to supplement~     fasting and clear liquid diet.~      This report claimed a noticeably better quality of small intestine cleansing and a 20%~     shorter transit time for the capsule by taking one dose of linaclotide one hour before~     patients swallowed the video capsule.~      The purpose of this study is to assess the use of one dose of linaclotide in terms of the~     total time it takes the capsule to move through the small bowel, and image quality as~     compared to the current method. The results of this study will be compared to previous~     patients who drank the preparation that is currently used~   "
84164|NCT02465372|"~     The purpose of this project is to develop a Comprehensive School Physical Activity Program~     (CSPAP) training protocol, and test the feasibility, acceptability, and effectiveness of its~     delivery in an elementary school setting.~   "
84165|NCT02465359|"~     The investigators are using self administered subcutaneous IG in patients with CIDP who~     require IVIG. Safety, efficacy, and patient satisfaction will be examined.~   "
84166|NCT02465346|"~     Treatment of acute stroke must be fast. The aim of this trial is to show feasibility, safety~     and clinical benefit of a strategy of diagnosis and treatment directly at the emergency site~     for hyperacute treatment and transfer to the most appropriate target hospital. The effects on~     reduction delays until different stroke treatments will be assessed. First estimations of~     cost-effectiveness will also be performed.~   "
84167|NCT02465333|"~     Plantar heel pain is the most common problem of the foot. Plantar fasciitis is the leading~     cause of this pain, accounting for 11-15% of all foot symptoms seeking professional care, and~     occurs in 10% of the US population. The cause of heel pain can be from bone, soft tissue,~     nerve, or systemic disease. The second most common cause of heel pain is fat pad atrophy,~     followed by a combination of both fat pad atrophy and plantar fasciitis. [1-4] Fat pad~     displacement may be seen in the heel as well.~      Current treatments for plantar fasciitis include stretching and external support with~     orthotics with the goal of reducing local pressure as well as tissue breakdown.[5] However,~     patient compliance with extrinsic devices is challenging, and they may experience increased~     friction, irritation and breakdown at a different location on the foot due to thickness of~     the device in the shoe. Also, the patient must replace the device as soon as it breaks down~     but the breakdown often goes unnoticed. Failure of conservative management may lead to~     treatment with steroids or surgical intervention by endoscopic plantar fasciotomy, open~     fasciotomy or excision of bone spurs. Injection of steroids can instigate or exacerbate~     pre-existing heel fat pad atrophy. Autologous fat grafting to the heel may reduce plantar~     pressures, and thus serve as a treatment for heel pain. Autologous fat grafting is currently~     under investigation for a myriad of clinical scenarios.[6-19] Even though autologous fat~     grafting is not yet an established therapeutic approach for the cited indications, some of~     the reported results have been intriguing.[19] The variable resorption of fat, however, is an~     important confounding factor in all these studies. Currently the literature reports fat~     retention rates ranging from 25% to 80%.[20]~      The specific aim of this study is to assess the adipose stem cell characteristics in patients~     undergoing autologous fat grafting for heel fat pad atrophy and correlate these~     characteristics with fat retention. Data from this study will help determine the~     characteristics of the adipose stem cells in this population and open the door to additional~     studies. This pilot study will also help build new collaborative efforts between Foot and~     Ankle Specialists, Plastic Surgery, and Adipose Stem Cell Biologists, combining biomechanical~     expertise with fat grafting and basic science expertise.~   "
84168|NCT02465320|"~     The purpose of this study is to determine if COL-1077 (10% lidocaine vaginal bioadhesive gel)~     will be effective as an acute-use anesthetic and can decrease the pain intensity associated~     with gynecologic procedures using endometrial biopsy as a representative procedure.~   "
84169|NCT02465307|"~     Delirium, as a common complication of hospitalization, poses significant health problems in~     hospitalized patients. Though about a third of delirium cases can benefit from intervention,~     detecting and predicting delirium is still very limited in practice. A common~     characterization of delirium is changes in activity level, causing patients to become~     hyperactive or hypoactive which is manifested in facial expressions and total body movements.~     This pilot study is designed to test the feasibility of a delirium detection system using~     movement data obtained from 3-axis wearable accelerometers and commercially available camera~     and facial recognition video system, in conjunction with electronics medical record (EMR)~     data, to analyze the relation of whole-body movement as well as facial expressions with~     delirium.~   "
84170|NCT02465294|"~     The purpose of this study is to evaluate the addition of two different probiotic~     interventions to a comprehensive behavioral lifestyle intervention on body weight loss and~     overall health in overweight adults.~   "
84171|NCT02465281|"~     The objective of the preliminary study is:~        1. To identify correlations between brain lesions and sensorimotor impairments in stroke.~        2. To identify possible patterns between brain lesions and sensorimotor impairments that~          might increase our understanding in stroke recovery and guide further tailor-based~          neuro-rehabilitation~   "
84172|NCT02465268|"~     The purpose of this research study is to determine if an investigational dendritic cell~     vaccine, called pp65 DC, is effective for the treatment of a specific type of brain tumor~     called glioblastoma (GBM) when given with stronger doses of routine chemotherapy.~   "
84173|NCT02465255|"~     Acute abdominal pain is a frequent symptom in children admitted to the emergency department .~     In the past the fear of masking a surgical condition has justified withholding analgesia in~     patients with acute abdominal pain. By the 2000s, some clinical trials established that~     opioid analgesia before surgical consultation does not affect diagnostic accuracy or outcome~     in children with acute abdominal pain. Despite this, acute abdominal pain is still~     undertreated in this setting. Published paediatric trials studied the effect of opioid~     analgesia administered by parenteral route or by mouth. To the best of our knowledge no study~     investigated the effectiveness of sublingual analgesia.~      The purpose of this randomized controlled trial is to assess the effectiveness of three~     different drugs (ketorolac, tramadol, paracetamol), administered by the sublingual route, in~     children complaining of acute abdominal pain.~   "
84201|NCT02464891|"~     This study evaluates the effect of CCX168, a C5aR Antagonist, Oral Administration on Ex Vivo~     Thrombus Formation and Disease Activity in ten patients with diagnosis of Atypical Hemolytic~     Uremic Syndrome with or without genetic abnormalities in the complement system or~     thrombomodulin, on stable chronic extracorporeal or peritoneal dialysis therapy since at~     least 6 months.~   "
84174|NCT02465242|"~     Traumatic brain injury (TBI) is a major cause of morbidity and mortality in the US. The CDC~     states that 1.7 million people sustain a traumatic brain injury each year, with death~     occurring in 52,000 of these injured patients. It is also estimated that 275,000 yearly~     require hospitalization. The costs of TBI can be devastating to our society, with the 2010~     economic cost estimated to be approximately $76.5 billion. 90% of this cost involves fatal or~     hospitalized brain injured patients. Furthermore, survivors of traumatic brain injury have~     high rates of institutionalization, readmission, and disability.~      The prediction of prognosis in severe TBI is a difficult problem for physicians. Prognosis~     evaluation in the acute phase of care varies widely among physicians caring for these~     patients[3]. With prognosis often in doubt, physicians have difficulty leading families and~     patients toward the most appropriate treatment which often leads to expensive testing and~     patient management. The Brain Trauma Foundation has recommended several early indicators of~     prognosis in severe TBI, including age, hypotension, CT scan features, Glasgow Outcome Scale~     score, and pupillary diameter with light reflexes. Pupillary diameter and light reflexes have~     been extensively studied, however accurate measurements of these prognostic factors have not~     been performed due to a lack of standardized measuring procedure.~      A new device has been validated to measure both pupil size and reactivity using infrared~     pupillometry. This device has also been studied to create the Neurological Pupil Index (NPi)~     as a measure of pupillary reactivity. The NPi has been shown to correlate with intracranial~     pressure readings, however there are no studies correlating the pupillometer findings with~     outcome measures in TBI. This study will prospectively evaluate the pupillometer readings of~     pupillary size and reactivity (NPi) to test the hypothesis that the NPi is a realiable~     predictor of 30-day outcomes in patients with severe TBI.~   "
84175|NCT02465229|"~     Biliary strictures present a diagnostic and therapeutic challenge to clinicians due to~     unsatisfied accuracy of sampling modality. The major problem is very difficult to discern~     malignant from non-malignant strictures, such as patients with primary sclerosing cholangitis~     (PSC). With the poor prognosis and high mortality rate of advanced stage of~     hepatopancreaticobiliary malignancies, early and accurate diagnosis impacts patients' outcome~     and possible surgical candidacy. Therefore, a pre-operative determination of malignancy to~     help plan appropriate treatment is highly desirable.~      Before 2000s, several diagnostic modalities, including laboratory tests, ultrasonography~     (US), computed tomography (CT) scan, cholangiography by percutaneous transhepatic~     cholangiography endoscopic (PTC) and endoscopic retrograde cholangiopancreatography (ERCP),~     and brushing cytology disclosed 13% to 24% false positive rate for suspicious malignant hilar~     strictures. Compared to recent studies, ERCP brushings still suffer from low sensitivity~     (41.6% ± 3.2% (99% CI)) and negative predictive value (58.0% ± 3.2% (99% CI)). In order to~     increase diagnostic accuracy, at least two sampling methods, including brushing cytology,~     biopsy, and fine-needle aspiration is therefore recommended. One article showed multimodal~     tissue-sampling (Brushing + Biopsy + Fine-needle aspiration) increased the sensitivity for~     diagnosis of malignant biliary stricture to 62%. However, no any literature demonstrate the~     best sequence of combined sampling modalities to yield the highest diagnostic accuracy.~     Besides, the role of stricture dilation before or after different tissue sampling modality is~     still uncertain.~      In this study, the investigators want to compare stricture dilation before or after~     multimodal tissue-sampling, including brush cytology, intraductal suction and forceps biopsy~     for the diagnosis of malignant biliary stricture and also assess which kind of the sequence~     of combined tissue-sampling modalities could offer the highest diagnostic accuracy.~   "
84176|NCT02465216|"~     The purpose of this study is to evaluate the safety and immunogenicity of ID93 + GLA-SE~     vaccine when administered to adult pulmonary Tuberculosis (TB) patients, following successful~     completion of TB treatment with confirmed bacteriologic cure, in preparation for a future~     Phase 2b prevention of TB recurrence trial in the same population.~   "
84177|NCT02465203|"~     Follow-up for viral activity, changes in liver function and safety in patients with no SVR24~     in feeder studies~   "
84178|NCT02465190|"~     This is a case-control study embedded in a surveillance system to determine the effectiveness~     of antenatal maternal influenza vaccination against laboratory-confirmed influenza-associated~     hospitalised illness in infants <6 months of age.~   "
84179|NCT02465177|"~     Unhealthy alcohol use is present in up to 38% of the 4 million patients admitted to an~     American intensive care unit (ICU) each year in the US. Despite the high prevalence of~     unhealthy alcohol use in ICU survivors, routine interventions targeted at reducing alcohol~     consumption, alcohol-related consequences, and illness related to alcohol are not currently~     part of the multidisciplinary approach to critical care. Although screening, brief~     intervention, and referral to treatment (SBIRT) has been described in several healthcare~     settings, it fails to address common characteristics of medical ICU survivors including high~     rates of alcohol use disorders, cognitive dysfunction, psychiatric comorbidities, and~     intimate involvement of friends and family. This study uses a qualitative approach to further~     understand the needs of medical ICU survivors with unhealthy alcohol use. The investigators~     hypothesize that there are common, modifiable barriers to improving alcohol-related outcomes~   "
84180|NCT02465164|"~     The purpose of this study is to compare if using a Cook Cervical Ripening Balloon in~     conjunction with low dose oxytocin is more effective at shortening labor induction times than~     the Cook Cervical Ripening Balloon alone. After obtaining consent, patients will be randomly~     divided into a Balloon with oxytocin or Balloon only group. The Balloon will be placed by~     either Resident or Attending Physicians and left in place for 12 hours (protocol) in both~     groups or until it falls out. After either 12 hours or the Balloon falls out, oxytocin will~     be used for the remainder of the induction per current hospital protocol. Time to delivery,~     mode of delivery, average number of hours Balloon remained in place, non-reassuring fetal~     heart tracings, adverse outcomes (ie fetal malpresentation, postpartum hemorrhage) will be~     recorded.~   "
84181|NCT02465151|"~     The primary objective of this trial is to identify how much protein is required at breakfast~     to promote positive whole body protein balance over the following 9h period.~   "
84182|NCT02465138|"~     Determine if IV ketorolac is an effective agent in the prevention of post-ERCP pancreatitis.~     Determine if IV ketorolac provides improved post-procedure analgesia.~      Determine if systemic mediators of inflammation are reduced in patients receiving IV~     ketorolac following ERCP.~   "
84183|NCT02465125|"~     BACKGROUND~        -  Vascular surgical patients often receive red blood cell (RBC) transfusions in the~          peri-operative period~        -  RBC transfusion may lead to improved outcome but on the other hand the intervention may~          be harmful~        -  Danish Health and Medicines Authority recommends transfusion of RBC at hemoglobin below~          5 mmol/L while local clinical guidelines recommend transfusion of RBC to maintain~          hemoglobin levels above 6 mmol/L~        -  A large randomized clinical trial is needed to evaluate the efficacy and safety of RBC~          transfusion in patients undergoing vascular surgery.~        -  A trial examining the effect of RBC transfusion on tissue oxygenation is used to test~          the trial-design and feasibility for a trial evaluating post-operative mortality and~          morbidity.~   "
84184|NCT02465112|"~     TERAVECT is a phase III randomized study of patients with digestive neuroendocrine tumors~     after complete surgical resection of liver metastases treated with In111-Pentetreotide-based~     adjuvant radiotherapy.~      In this study, targeted radionuclide therapy is used at an earlier stage of the disease.The~     objective is to target residual tumor cells and/or micrometastases which escaped surgical~     resection. Given the poor prognosis associated with recurrence, this treatment should prevent~     relapse.~   "
84185|NCT02465099|"~     The OSTEOVUE™ Spine Dissector is a new ultrasonic energy device, specifically designed for~     soft tissue removal from vertebral surfaces. The aim of the present study is to compare blood~     loss in multilevel PSF surgeries in patients with adolescent scoliosis (idiopathic or~     neuromuscular) done with ED or with UD. Blood loss will be estimated by major intraoperative~     surgical Stage (1 and 2) and postoperatively (until discharge). Additionally, the study will~     assess the possible influence of the device use in secondary perioperative outcomes.~   "
84186|NCT02465086|"~     The purpose of this study is to investigate the correlation and the causality direction~     between mastering linguistic tests and second-order reasoning tasks in the autistic~     population. Linguistic tests include two types of tasks: 1. Mastery of multiple embeddings or~     recursion and 2. Mastery of dialogue particles. Second-order tests include standard~     false-belief tasks.~   "
84187|NCT02465073|"~     Determine the effect on wound treatment outcomes using a novel antimicrobial wound gel~     (NXTSC) for the treatment of infected wounds as the sole topical treatment of microbial~     infection at the wound site.~   "
84188|NCT02465060|"~     This phase II MATCH trial studies how well treatment that is directed by genetic testing~     works in patients with solid tumors or lymphomas that have progressed following at least one~     line of standard treatment or for which no agreed upon treatment approach exists. Genetic~     tests look at the unique genetic material (genes) of patients' tumor cells. Patients with~     genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more~     from treatment which targets their tumor's particular genetic abnormality. Identifying these~     genetic abnormalities first may help doctors plan better treatment for patients with solid~     tumors, lymphomas, or multiple myeloma.~   "
84189|NCT02465047|"~     Background: Epilepsy and nonepileptic attack disorder (NEAD) are chronic conditions that~     cause many patients to experience a great degree of stress in their everyday lives. Patients~     have also reported stress as the commonest trigger of their seizures, and animal studies~     suggest that stress can make seizures worse. A self-help intervention that would help people~     manage the stress they experience could therefore improve their quality of life and have~     positive effects on the frequency of their seizures.~      Research Question: The study evaluates whether a self-help intervention in the form of a~     brief booklet can improve the quality of life and reduce the levels of stress of people who~     experience seizures. In addition, the study will explore the associations between seizure~     severity and frequency, physiological and self-reported stress, and anxiety and depression.~      Design: The researchers are recruiting patients attending the Outpatient Neurology Clinic at~     the Royal Hallamshire Hospital and measure their quality of life and stress levels before,~     one month and two months after they have been given the self-help stress reduction booklet.~     The researchers will measure the changes in quality of life and stress levels using~     questionnaires and saliva samples.~   "
84190|NCT02465034|"~     The purpose of this study is to examine how different areas in the brain interact with each~     other and how using brain imaging and brain stimulation approaches can influence these~     interactions.~   "
84191|NCT02465021|"~     The goal of the proposed research is to investigate the effects of novel snack products~     differing in macronutrient composition, fibre and sugar content on post-prandial glycemia and~     short-term appetite control in healthy adults.~   "
84192|NCT02465008|"~     The purpose of this study is to determine whether levobupivacaine is effective in the acute~     postoperative pain treatment in periprosthetic breast augmentation~   "
84193|NCT02464995|"~     The purpose of this study is to demonstrate the effectiveness of bronchial thermoplasty in a~     severe asthmatic population with frequent exacerbations.~      This will be a single center randomized and controlled study. Thirty subjects with severe~     asthma (Gina 4 and 5) with frequent severe exacerbations (four or more bursts of systemic~     corticosteroids >3 days each in the previous year) will be randomized 1:1 to either the~     thermoplasty group (bronchial thermoplasty and medical management) or control group (medical~     management only).~   "
84194|NCT02464982|"~     Mammary reconstruction replaces total skin transplant, which may causing patient discomfort.~     It is a simple, painless and reproductible technology that avoids consequences and~     complications related to transplant. Tattoo helps patients to return faster to the normal~     life and close more easily the cancer episode.~      The study purpose is to measure the patient's esthetic satisfaction degree on 1year areola~     tattoo realized following standard care.~   "
84195|NCT02464969|"~     To assess the safety and descriptive efficacy of apixaban in pediatric subjects requiring~     anticoagulation for the treatment of a VTE.~   "
84196|NCT02464956|"~     No treatments exist for Age-related Macular Degeneration (AMD) when there is cell loss such~     as in late wet AMD or dry AMD. The differentiation of RPE cells from patient derived iPSC~     will offer valuable source of tissue for transplantation in these forms of AMD and may form~     basis for a future treatment option in terms of cell transplantation.~   "
84197|NCT02464943|"~     The Zenith® Dissection extended study is to collect confirmatory safety and effectiveness~     data on the Zenith® Dissection Endovascular System in the treatment of acute, complicate Type~     B aortic dissection.~   "
84198|NCT02464930|"~     The primary purpose of this study is to test new methods to diagnose BE in time before it~     turns into advanced cancer. Once BE is diagnosed, the current standard of care is to monitor~     the disease so that complication such as cancer can be diagnosed early. The two new methods~     the investigators are evaluating are: a) blood test and b) brush test of the food pipe. The~     investigators will collect blood, bile and cells from the food pipe and stomach and measure~     for a biomarker called microRNA (miRNA). In the future, measurements of microRNA biomarkers~     could help the doctors figure out which patients are at increased risk for cancer of the~     esophagus.~   "
84199|NCT02464917|"~     The purpose of this study is to compare umbilical cord gases in subjects receiving oxygen at~     10L/min via simple facemask to subjects receiving room air in those presenting for scheduled~     cesarean sections.~   "
84200|NCT02464904|"~     Can neoadjuvant intrapleural cryotherapy be safely performed in patients with malignant~     pleural mesothelioma and will it trigger substantial systemic and local pro-inflammatory~     changes, resulting in the induction of anti-tumor immunity?~   "
84202|NCT02464878|"~     Patients meeting the study entry criteria will receive 1-3 infusion(s) of in vitro cultured~     islets. Patients will receive three times a week AAT infusions in the peri-transplant period~     for three weeks.~   "
84205|NCT02464839|"~     This study was designed to demonstrate the prevalence of onychomycosis in hallux valgus~     patients. Additionally, all the prevalence of tinea pedis, the pattern of clinical~     manifestations, risk factors and coexistence foot deformities with hallux valgus were~     observed and recorded.~   "
84206|NCT02464826|"~     This study was designed to demonstrate the efficacy of this product in non-dermatophyte~     (Scytalidium dimidiatum) onychomycosis and chronic paronychia treatment in Thai patients.~   "
84207|NCT02464813|"~     This study aims to evaluate the incidence of longterm pain after spinal fusion surgery in~     children and adolescents. In the second part of the study a randomized double-blind clinical~     trial will be conducted. We compare the effect of pregabalin versus placebo on postoperative~     pain and oxycodone consumption. We will also be able to evaluate the effect of pregabalin on~     neurophysiological monitoring during surgery.~   "
84208|NCT02464800|"~     The medical records of 393 eyes of 326 patients with severe proliferative diabetic~     retinopathy were reviewed. Higher cutting rate instruments (5000 cut per minute) were used in~     174 eyes and conventional instruments in 219 eyes (2500 cut per minute). The visual outcome~     and incidences of intraoperative and postoperative complications were compared.~   "
84209|NCT02464787|"~     Skin Carotenoid Scores (SCS) are a biomarker of overall antioxidant status. This study~     extends an earlier study in which an increase in skin carotenoid scores (SCS) was observed in~     subjects who increased their intake of fruits and vegetables. The scores were determined~     using the Raman Spectroscopy. In that study subjects were assigned to one of four groups~     based on their baseline SCS. For unknown reasons, the groups with the highest and lowest~     baseline SCS failed to show an increase whereas the two intermediate groups did. One possible~     explanation might be that intakes varied more than expected and was not obvious due to~     self-reporting of intake of fruits and vegetables with different contents.~   "
84210|NCT02464774|"~     RATIONALE: Triple-negative breast cancer (TNBC) is an aggressive subtype shown to have a high~     risk of locoregional recurrence (LRR) and distant metastasis (DM). The equivalent impact of~     breast-conserving therapy (BCT) and mastectomy on disease-free survival in patients with~     early breast cancer has been established by a number of large randomized controlled trials~     and meta-analysis. However, ongoing dispute exists on whether TNBC is a good candidate for~     BCT.~      PURPOSE: This prospective, randomized, open, single-center Phase III clinical study is~     conducted to compare efficacy and safety of breast-conserving therapy and mastectomy in~     treating Chinese patients with early TNBC.~   "
84211|NCT02464761|"~     An estimated 10 percent of primary breast, prostate, lung, thyroid and renal cell tumors~     metastasize to the spine. The majority of these tumors are detected before surgical~     intervention is required and most patients receive radiation therapy for symptomatic relief.~     Complete pain control, duration of pain control, high recurrence rates and soft tissue~     complications make radiation a less than ideal treatment. Also, pre-operative radiation~     therapy is a significant negative predictor for surgical outcomes. To improve the treatment~     options for patients with advanced cancer with spinal lesions the research team investigated~     a new minimally invasive therapy known as photodynamic therapy (PDT) that targets metastatic~     spine lesions with limited side effects. PDT involves the use of a photo-activated~     chemotherapeutic agent, given intravenously that when stimulated by non-thermal~     wavelength-specific light allows for selective ablation of tumor tissue. The light is~     delivered to the spine through small fiber optic cables using a diode laser. By combining~     canine and porcine studies the investigators have strong evidence to support that PDT is both~     safe and effective for the treatment of metastatic tumors in the spine. PDT is targeted,~     repeatable, minimally invasive and has limited local and systemic side effects. Its use would~     enhance the treatment options for patients with advanced stage cancer. The goal of the~     present study is to demonstrate that PDT can be safely and effectively given to treat spinal~     metastases in patients with advanced stage cancer who have multiple lesions or who have~     failed radiation or surgical intervention. The effectiveness of this treatment will be~     determined through clinical and radiographic endpoints along with recurrence and survival.~     The investigators intend to demonstrate that PDT is a minimally invasive method with low~     morbidity and mortality by which spinal tumors can be ablated and later stabilized through~     vertebroplasty, optimizing quality of life and providing effective treatment.~   "
84212|NCT02464748|"~     Motor neurone disease (MND) is a rare but debilitating neurological condition that causes~     paralysis of the body's muscles leading to severe disability and eventually death. Patients~     often struggle to travel the long distances to specialist clinics to receive the care they~     require whilst this expert care is often unavailable in the community. Telehealth has the~     potential to enable a specialist team to monitor the health and wellbeing of patients and~     their carers whilst they are at home. This could improve the patient's health, improve the~     quality of life of both patients and their carers, and lead to more effective use of health~     resources.~      This is a randomised controlled pilot study that will involve 40 patients who are cared for~     by the Sheffield Motor Neurone Disease care centre and their main informal carer (a total of~     80 participants). Half of the participants will use the telehealth system for a minimum of~     six months and maximum of eighteen months and information will be collected from patients,~     carers and their care team. This will include collecting clinical outcome measures, health~     resource use and the opinions and experience of using the system. All participants will~     continue to receive their usual care.~      This is a pilot study. It aims to determine the feasibility and acceptability of the~     telehealth system to patients, carers and their health care providers. It also aims to~     determine how a larger trial could successfully evaluate the clinical and cost-effectiveness~     of the system.~   "
84213|NCT02464735|"~     Mechanically ventilated patients in the Intensive Care Unit (ICU) are highly susceptible to~     sleep disruption. Several studies in the last 15 years have demonstrated an extremely poor~     sleep quality and abnormal sleep pattern evaluated by polysomnography (PSG) devices (the gold~     standard method for evaluating sleep quality and quantity). Discontinuation of mechanical~     ventilation should be considered as soon as possible when a patient's condition starts to~     improve. A patient's ability to be weaned from the mechanical ventilator can be assessed~     using two step approaches including a Rapid Shallow Breathing Index (RSBI) calculation then a~     spontaneous breathing trial (SBT) to determine the likelihood of success or failure before~     considering endotracheal extubation. The rate of weaning failure from the first SBT attempt~     has been reported to be 35-55%. The reason for weaning failure may be complex and~     multifactorial. An association between sleep disruption and weaning outcome has never been~     studied. The goal of this study is to look for an association between poor sleep quality and~     failure of a weaning attempt.~      This study is an observational, physiological study investigating sleep quality and quantity~     in patients who will be weaned by recording standard PSG (from 17:00 to 08:00) at night~     before a weaning attempt. Sleep characteristics of patients failing or passing the weaning~     attempt will be compared. In addition, we will compare sleep patterns before and after~     endotracheal extubation.~   "
84214|NCT02464722|"~     During endoscopic sinus surgery (ESS), epinephrine local injection and controlled hypotension~     is essential in order to increase the visibility in the operative field and reduce the risk.~     This study is comparing of dexmedetomidine and remifentanil before epinephrine local~     injection for controlled hypotension during ESS.~   "
84215|NCT02464709|"~     This study compares two photosensitizing creams' BF-200 ALA's (aminolevulinic acid, Ameluz®)~     and MAL's (methyl 5-aminolevulinate, Metvix®) efficacy on actinic keratoses in natural~     daylight photodynamic therapy (NDL-PDT). The participants' facial skin or scalp will be~     randomized in two sides and one side is treated with BF-200 ALA and the other side with MAL.~     Result of the treatment is assessed with clinical examination 12 months after treatment. The~     investigators will also compare delayed skin reactions after treatment and cost-effectiveness~     of both photosensitizer creams.~   "
84216|NCT02464696|"~     The goal of this clinical research study is to learn whether using early non-invasive~     positive pressure ventilation (NIPPV), a method of delivering oxygen using a mask, or high~     flow oxygen (using a tube with 2 prongs placed in the nostrils) is better at improving the~     amount of oxygen in your blood, reducing shortness of breath, and the need for intubation~     (placement of a tube in the windpipe) in patients with cancer and hypoxemia (a low level of~     oxygen in the blood).~      This is an investigational study. Both NIPPV and high flow oxygen are FDA approved for~     hypoxemia. Comparing these procedures in reducing shortness of breath and the need for~     intubation is investigational.~      Up to 366 participants will be enrolled in this study. All will take part at MD Anderson.~   "
84217|NCT02464683|"~     Tuberculosis (TB) is the second largest infectious disease that causes death in the last 4~     centuries in all the world. Observational studies found an association between vitaminD and~     TB, suggesting a potential therapeutic role of vitaminD supplementation in patients with~     active tuberculosis. The hypothesis is that the administration of vitaminD is associated with~     changes in the levels of cytokines in patients with tuberculosis treated with first-line~     drugs. The aim of this study is to evaluate the effect of vitaminD supplementation on the~     clinical course, the time of negative smears and cultures, and the effect on the immune~     response in patients with pulmonary tuberculosis (TBP).~   "
84218|NCT02464670|"~     This study evaluates whether INO-4212 and its components INO-4201 and INO-4202 administered~     intramuscularly (IM) or intradermally (ID) followed by electroporation (EP) will be well~     tolerated and immunogenic.~   "
84219|NCT02464657|"~     The goal of this clinical research study is to find the highest tolerable dose of nivolumab~     that can be give in combination with idarubicin and cytarabine in patients with MDS and AML.~     The safety and effectiveness of this drug combination will also be studied.~      This is an investigational study. Nivolumab is not FDA-approved or commercially available.~     Idarubicin is FDA-approved and commercially available for the treatment of patients with AML.~     Cytarabine is FDA approved and commercially available for treatment of patient with AML. The~     use of these drugs in combination is investigational. The study doctor can explain how the~     drugs are designed to work.~      Up to 75 patients will take part in this study. All will be enrolled at MD Anderson.~   "
84220|NCT02464644|"~     Hereditary Hemorrhagic Telangiectasia (HHT) affects 1 in 5,000 people. The purpose of this~     study is to provide data regarding the frequency of common health conditions and the~     tolerability of therapies in HHT by using a questionnaire.~      This will be filled in by both people with HHT, and controls who will be members of the~     general population without HHT.~      The questionnaire has been designed primarily for web based entry, but can also be circulated~     in paper format on request~   "
84221|NCT02464631|"~     In this prospective randomized trial, A Minimum of 300 consecutive patients of decompensated~     HCV (Hepatitis C Virus) related cirrhosis, presenting to the Institute of Liver and Biliary~     Sciences hospital will be included and those patients meeting the entry criteria received~     treatment with 400 mg of Sofosbuvir, administered orally once daily, and Ribavirin~     administered orally twice daily, with doses determined according to body weight(600 mg daily~     in patients with a body weight of ≤60 kg,800 mg daily in patients weighing >60 and ≤80 kg,~     and1000 mg daily in patients with a body weight of >80 kg). Based on the treatment duration,~     patients would be randomized in either of the 3 treatment groups -~        -  Group 1 - Sofosbuvir + Ribavirin x 24 weeks~        -  Group 2 - Sofosbuvir + Ribavirin x 36 weeks~        -  Group 3 - Sofosbuvir + Ribavirin x 48 weeks~   "
84222|NCT02464618|"~     Non-attendance to out-patient endoscopic procedures is high among underserved blacks. The~     overall goal of this proposal is to evaluate the effect of directly involving a social~     contact (chosen by the patient) on completion and quality of out-patient endoscopy~     recommended for the patient by his/her primary care physician, or after scheduling by the~     gastrointestinal endoscopist.~      Improved adherence and better quality of procedures are postulated with involvement of social~     contacts.~   "
84223|NCT02464605|"~     This Study will evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of~     a single intravenous infusion of SEL-037 (pegsiticase), a pegylated uricase, in subjects with~     elevated blood uric acid levels. Uricase is an enzyme that converts uric acid to the readily~     soluble allantoin that is then excreted.~   "
84224|NCT02464592|"~     The purpose of this study is to evaluate the diagnostic yield and safety of transbronchial~     lung biopsies (TBLB) with cryoprobe versus conventional forceps in patients with diffuse lung~     disease.~   "
84225|NCT02464579|"~     The objective of this study is to measure the breastfeeding success for all preterm and term~     newborns in our department of neonatology during the hospital stay and at the age of six~     months.~   "
84226|NCT02464566|"~     With low carbohydrate dietary approach for both arms, the investigators will examine the~     effectiveness of 12-weeks intensive lifestyle intervention program provided in individual~     sessions in primary health care obesity clinic in Jeddah with aim to achieve 5% reduction of~     baseline weight for experimental participants in comparison with active comparator group~     (only one health education session).~   "
84227|NCT02464553|"~     In this prospective multi-centre double-blind trial the effect of the X-ray examinations~     controlled periradicular therapy should be examined in (approximately 300) adult patients~     with low back pain pain caused by foraminal stenosis radiculopathy or spinal stenosis.~      A periradicular therapy (PRT) is a special radiological, low-risk therapy for chronic back~     pain caused by wear and tear of the cervical, thoracic, and lumbar spine or a herniated disc~     or disc bulge. Partially pain might also radiate to the hips or extremities and cause~     radicular symptoms.~   "
84230|NCT02464514|"~     The hyperghrelinemia of children with PWS provides a unique model by which to explore the~     hormonal and metabolic effects of orexigenic hormones in normal and pathologic conditions. An~     important question to be addressed by this proposed research includes the macro-nutrient~     regulation of ghrelin and PYY in obese children and children with PWS. As ghrelin antagonists~     are considered potential future anti-obesity agents, it is essential to gain understanding of~     the developmental, nutritional and hormonal regulation of this important orexigenic hormone~     in children.~   "
84231|NCT02464501|"~     The purpose of this study is to assess the safety and efficacy of paclitaxel administration~     using the occlusion perfusion catheter (OPC) for the prevention of restenosis in~     infrainguinal de novo, restenotic femoropopliteal and infrapopliteal stenoses and occlusions,~     and in-stent restenosis.~   "
84232|NCT02464488|"~     Several new oral direct anticoagulants have been recently marketed. However, only a few,~     limited, studies have provided data about the pharmacology of new oral direct anticoagulants~     in older persons. This study try to better define wether the pharmacology of each of these 3~     drugs (dabigatran, rivaroxaban and apixaban) is actually significantly different in very~     older patients (over 80) and to which extend. The investigators also try to characterize the~     main determinants (age, weight, renal function, co-morbidities, etc) of the variability~     observed between individuals in their response to he drugs studied. The method employed is a~     population pharmacokinetic/pharmacodynamic study.~   "
84233|NCT02464475|"~     Recent evidence suggested that the anterior insula cortex seems to be the main site of~     interoception. Several studies showed an association between change in insula function and~     interoception, bodily perception and consciousness in subjects with chronic pain. Although~     osteopathic research has been demonstrated to be effective in reducing pain, studies~     exploring the effect of osteopathy on interoception are lacking. Therefore, the aim of the~     present study is to explore the extent to which osteopathic treatment could modify~     interoception parameters both measuring brain functional connectivity and clinical~     questionnaires.~   "
84234|NCT02464462|"~     The purpose of this study is to investigate the effect of vitamin D3 and calcium~     supplementation in attenuating type 2 diabetes mellitus outcomes in ethnic diverse, diabetic~     patiens.~   "
84235|NCT02464449|"~     This study will evaluate a new approach for back pain care management using artificial~     intelligence and evidence-based cognitive behavioral therapy (AI-CBT) so that services~     automatically adapt to each Veteran's unique needs, achieving outcomes as good as standard~     care but with less clinician time.~   "
84236|NCT02464436|"~     hRPC is a cell therapy for retinitis pigmentosa. This is a first-in-human, dose escalation~     study in which participants with retinitis pigmentosa will receive a single subretinal~     injection of hRPC cells in one eye to evaluate safety and tolerability.~      Participants will be followed for one year to evaluate the safety and tolerability of hRPC~     Additional testing will seek to establish any preliminary efficacy from hRPC.~   "
84237|NCT02464423|"~     Like most of sub-Saharan Africa, Rwandan youth are the epicenter of the AIDS epidemic,~     accounting for 40% of new infections. Antiretroviral (ART) adherence is a global health~     priority, but Rwandan youth are more than twice as likely to be on second line therapy than~     adults, and with a median population age of 18.7 years old, adherence is essential for~     Rwanda's future. Resources to provide youth-centered medical and psychosocial care are~     limited in Rwanda, and young people with HIV face many obstacles to adherence, namely the~     long-term consequences of genocide, depression, and gender-based violence, as well as~     logistical issues, negative attitudes, and insufficient parent/caregiver support. Preliminary~     data underscore the utility of culturally-adapted, trauma-informed cognitive behavioral~     therapy (TI-CBT) in reducing depression and traumatic distress among youth and adults in~     Rwanda. This project proposes a 2-arm randomized controlled trial (RCT) to test and compare~     the efficacy of adherence-enhanced Trauma Informed Cognitive Behavioral Therapy (i.e.,~     TI-CBTe) to usual care in increasing ART adherence among Rwandan youth from two clinics~     caring for the largest number of youth with HIV in Rwanda. This proposal answers a compelling~     need for innovative programs to increase ART adherence among HIV+ youth. If effective, the~     study will build Rwanda's capacity to provide much needed services; and, involvement by the~     Rwanda Biomedical Center will ensure wide dissemination.~   "
84238|NCT02464410|"~     The high rate of adverse events, including overdose, resulting from opioid pain medication~     use threatens the quality and safety of pain care in the Veterans Health Administration (VHA)~     and elsewhere and is a critical public health problem in the United States. Pain is a highly~     common condition among VHA patients, and opioid therapy constitutes a primary mode of pain~     treatment.~      This study seeks to address this issue by conducting a randomized controlled trial of a brief~     conversation to improve opioid safety among Veteran patients receiving long-term opioid~     therapy. Veterans receiving opioid therapy for pain in primary care will be recruited and~     randomized to receive either a single session motivational intervention focused on safe~     opioid use or an equal attention control condition. The primary hypothesis is that the~     motivational intervention will improve opioid safety, decrease risk behaviors, aberrant~     opioid use, and total quantities of opioids prescribed relative to the control condition.~     Study findings will inform efforts to ensure the safety and well-being of Veteran patients~     with pain.~   "
84239|NCT02464397|"~     The purpose of this study is to compare vascular healing of the stented segment after~     deployment of titanium-nitride-oxide coated cobalt-chromium OPTIMAX™ bio-active stent (BAS)~     and SYNERGY™ everolimus-eluting stent (EES) in patients with acute coronary syndromes~     requiring percutaneous coronary intervention.~      Patients treated with BAS will be treated with DAPT for at least 4 weeks after the procedure~     followed by aspirin alone, while patients in the EES group will be treated with DAPT, at~     least for 6 months post procedure. In addition, this study will collect initial information~     about the safety and effectiveness of the BAS in comparison with EES group at 30 days, 6~     months, and 12 months.~   "
84251|NCT02464241|"~     The purpose of this study is to investigate which clinical colour vision assessment fits best~     for preschool children and school children. The investigators are going to investigate~     children with a known colour vision affecting ocular disease, as well as healthy children~     without colour vision deficiency. The goal is to compare the usability and validity of three~     different clinical tests for colour vision assessment which are already well established in~     adults but not yet in children.~   "
84240|NCT02464384|"~     Multicenter, prospective, open-label, cohort study. Primary objective: Determination of the~     predictive value of US alone and in combination with cartilage biodegradation markers on~     radiographic progression (change in Ratingen score)~      Secondary objectives:~        -  Correlation of ultrasound synovitis score and clinical disease activity score~        -  Determination of the sensitivity of ultrasound erosion detection compared to MRI~        -  Assessment of the value of including tenosynovitis assessment for predicting~          radiographic progression~        -  Assessment of the predictive value of ultrasound synovitis score at baseline for the~          need to install biologic DMARDs~   "
84241|NCT02464371|"~     ICU acquired muscle weakness (IAMW) is a common disease that is associated with high~     morbidity and mortality. Patients with septic shock are particularly at risk.~      The diagnosis of IAMW is clinical and based on the rating of the Medical Research Council~     score (MRC score). A MRC score lower than 48 defines the IAMW. But this evaluation is only~     usable in sufficiently awaken patients.~      Several studies have highlighted the role of microRNAs in regulating physiological processes~     and diseases related to the skeletal muscles. To date, no study was interested in IAMW.~      The aim of this study is to compare the microRNA detection kinetics on the appearance of~     IAMW.~      In septic shock patients, the kinetics of nine microRNAs will be compared between two groups:~     those with IAMW (IAMW + group) and those without IAMW (IAMW - group).~   "
84242|NCT02464358|"~     HPV infections are prominent among college-aged women. Although HPV vaccines decrease women's~     risk for cervical cancer, vaccination rates remain inadequate. This study explored the~     utility of an Information-Motivation-Behavioral Skills intervention in promoting HPV~     vaccination knowledge, motivation, and behavioral skills among college aged women.~   "
84243|NCT02464345|"~     The investigators have developed a new integrated therapy, namely a Healthy Approach to~     weIght management and Food in Eating Disorders (HAPIFED). HAPIFED is an enhanced behavioral~     weight loss therapy integrated with CBT for the management of EDs. HAPIFED uses CBT to treat~     ED behaviors and body image distress, whilst simultaneously emphasize a healthy lifestyle,~     the role of food and physical activity in mood regulation, and revised but clinically~     meaningful goals for weight loss. The investigators propose a randomized controlled trial~     (RCT) that will compare HAPIFED to CBT-E in people with obesity and either BN or BED. The two~     main aims will be to reduce symptoms of ED and to improve weight management. The RCT will be~     conducted in Sydney and in São Paulo with a one year follow-up.~   "
84244|NCT02464332|"~     Many types of cancer are primarily treated with surgery and patient survival is directly~     related to the extent to which the tumor is able to be removed. It is often difficult for~     surgeons to distinguish tumor tissue from normal tissue, and failure to surgically remove a~     cancer-affected lymph node or residual cancer at the surgical margin reduces a patient's~     chance of survival. Moreover, damage to adjacent normal tissue during surgery can result in~     significant morbidity. The investigators hypothesize that BLZ-100 will improve surgical~     outcomes by allowing surgeons to visualize the edges of the tumor and small groups of cancer~     cells that have spread to other sites in real-time as they operate. This is a safety study to~     assess the safety of BLZ-100 in patients with soft tissue sarcoma undergoing surgery.~   "
84245|NCT02464319|"~     Primary Sjögren's Syndrome (pSS) is an autoimmune disorder characterized by~     keratoconjunctivitis sicca and xerostomia. In addition, various extraglandular manifestations~     may develop. Several immunomodulating agents have been attempted in the treatment of pSS~     without achieving satisfactory results. Currently, there is no approved systemic treatment~     for pSS. Dysfunction of regulatory T (Treg) cells has been detected in diverse autoimmune~     diseases, which can be promoted by interleukin-2 (IL-2). The investigators hypothesized that~     low-dose IL-2 could be a novel therapy in active pSS patients. This clinical study will test~     the efficacy and safety of low dose IL-2 treatment in pSS. The investigators perform a~     single-centre, double-blind pilot trial with hrIL-2 in pSS. The investigators evaluate the~     effectiveness and safeness of low-dose hrIL-2 for primary Sjögren's Syndrome by randomized~     controlled study (hrIL-2 (N = 30) versus placebo group (N = 30)).~   "
84246|NCT02464306|"~     A prospective study to assess the efficacy and safety of fidaxomicin in Solid Organ~     Transplant (SOT) recipients (heart, lung, kidney, liver, kidney-pancreas, and pancreas) with~     a first-episode of Clostridium difficile infection (CDI).~   "
84247|NCT02464293|"~     This is a pilot study to see whether mindfulness-based cognitive therapy, which is a type of~     psychological therapy, is able to improve the psychological wellbeing of people who have the~     gene for Huntington's disease.~   "
84248|NCT02464280|"~     The investigators propose tomosynthesis as a imaging method in between of x-ray and CT. The~     expected value of this project is the definition of proven indications for tomosynthesis,~     which allow replacing CT. Specific goals are the early detection of pulmonary consolidations~     / parenchymal changes as well as the monitoring of patients with ostesynthetic implants.~   "
84249|NCT02464267|"~     The aim of this study is to develop a reliable and valid instrument to measure symptom~     management (experience and / or management strategies) during exacerbation episodes in CF~     patients. For the development a sequential exploratory two phase mixed-method study will be~     applied. In a first step, up to 25 CF patients will be interviewed: approximately 15 CF~     patients who experienced at least one episode of exacerbation in the past year and~     approximately CF 10 patients who are currently experiencing an exacerbation. The latter group~     will be interviewed up to 3 times during and after the antibiotic treatment. The instruments~     initial item list will be developed on basis of the interviews. Up to five health~     professionals will rate the items' relevance. In a further step, items' clarity and relevance~     will be assessed by cognitive debriefing interviews with no more than 10 patients. In the~     last step (part III), the instrument's preliminary construct and concurrent validity and~     reliability will be tested in a larger sample up to 150 patients experiencing exacerbation.~     Patients will be asked to complete the newly developed questionnaires and a set of other~     questionnaires at one time point. For part III, ethic approval will be asked at a later date~     (2015).~   "
84250|NCT02464254|"~     The investigators will conduct a 1-year prospective and randomized study to evaluate the~     initial efficacy of positive affect vs. an educational control to motivate physical activity~     in older adults with high burdens of chronic disease.~   "
84281|NCT02463851|"~     The GOLD FORCE trial investigates the differences between treatment with a Contact Force~     single-tip catheter against the PVAC GOLD multielectrode catheter in cardiac ablation~     procedures in patients with paroxysmal atrial fibrillation.~   "
84252|NCT02464228|"~     This Phase II studyis designed to investigate the antitumor activity in terms of objective~     response rate (ORR) of tipifarnib in 18 subjects with advanced Peripheral T-Cell Lymphoma~     (PTCL). The total number of patients could be extended to 30 pending on the degree of~     response observed at an interim analysis. Tipifarnib will be administered until disease~     progression then followed approximately every 12 weeks for survival until either death or 12~     months after accrual of the last study subject, whichever occurs first.~   "
84253|NCT02464215|"~     The purpose of this study is to evaluate the effect and safety of laparoscopy-assisted D2~     radical surgery for distal advanced gastric cancer.~   "
84254|NCT02464202|"~     The aim of this study lies in comparing the outcome of the proposed technique in a large~     sample size group to the outcome of the conventional tooth autotransplantation method and to~     provide sufficient evidence for improving the long-term success rate of the tooth~     autotransplantation procedure.~   "
84255|NCT02464189|"~     The aim of this study is to assess the knowledge, the attitudes and the practices of parents~     of asthmatic children.~   "
84256|NCT02464176|"~     This study will investigate the ability of systemic dexamethasone to prolong the sensory~     block duration for lumbar plexus nerve blockade.~   "
84257|NCT02464163|"~     The purpose of this study is to investigate the safety and immunogenicity of a recombinant~     hemagglutinin (rHA) influenza vaccine derived from A/Anhui/1/2013 (H7N9) administered at 3~     dose levels in adjuvanted (SE) rHA formulations and 1 dose levels in an unadjuvanted rHA~     formulation.~   "
84258|NCT02464150|"~     Up till 30 participants with celiac disease on a glutenfree diet are asked to consume gluten~     containing cookies for 3 days.~      Questionnaires and sampling of blood is done before, during and after.~   "
84259|NCT02464137|"~     single-modality phase I dose escalation toxicity study for first-line curative treatment of~     head and neck squamous cell carcinoma.~   "
84260|NCT02464124|"~     Hepatic encephalopathy (HE) is a reversible neuropsychiatric syndrome associated with chronic~     and acute liver dysfunction. It is characterized by cognitive and motor deficits of varying~     severity.~      Treatment options include lactulose administered orally or by nasogastric tube or enema,~     non-absorbable antibiotics, and protein-restricted diets.~      Nitazoxanide is an oral agent indicated for the treatment of infectious diarrhea caused by~     Crytpsporidiumparvum and Giardia lamblia. Basu and colleagues presented a pilot prospective~     study at the 2008 American Association for the Study of Liver Diseases meeting showing~     clinical improvement in HE among cirrhotic patients who received nitazoxanide and lactulose.~   "
84261|NCT02464111|"~     Research goals include evaluating the relative impact of maternal nutritional status versus~     recent dietary intake on breast milk micronutrient composition, and evaluating the impact of~     a maternal lipid based nutrient supplement (LNS) on breast milk micronutrient composition.~   "
84262|NCT02464098|"~     Diarrhea is a common problem in the pediatric population. Children with cancer are especially~     at increased risk for gastrointestinal infection-related morbidity and mortality due to their~     ongoing immunosuppression. However, the epidemiology of diarrheal illnesses in~     immunocompromised children is poorly understood. In the past, many or most cases of~     gastroenteritis have gone undiagnosed, largely due to a lack of sensitive diagnostic tests~     and a presumption that a large proportion of cases are due to treatment, rather than~     infections. The availability of new diagnostic tests that detect many gastrointestinal~     pathogens simultaneously offers the first opportunity to gain a comprehensive picture of the~     causes of infectious diarrhea in children with cancer.~      Researchers at St. Jude Children's Research Hospital want to learn about the epidemiology of~     diarrheal diseases in pediatric oncology patients utilizing broadly multiplexed, automated~     PCR.~   "
84263|NCT02464085|"~     The main goal of this program of research is to advance our understanding of how the severely~     damaged brain changes over the first 12-months post stroke. The investigators will determine~     'who recovers', 'who does not recover', and 'why'~   "
84264|NCT02464072|"~     This study evaluates the metabolic and clinical results of two well recognized and accepted~     surgical techniques in the management of severe hyperparathyroidism in patients under regular~     dialysis treatment.~   "
84265|NCT02464059|"~     This proposal will evaluate a potential mechanism of increased risk of lung function~     impairment, cathelicidin levels, as well as determine if vitamin D replacement can alter this~     pathway. This study will improve the understanding of factors which can lead to chronic lung~     disease. If effective, this application would also provide the justification to study vitamin~     D as a therapy to improve lung health.~   "
84266|NCT02464046|"~     The primary purpose of this study is to investigate the effect of JNJ-42847922 (change versus~     placebo) on sleep efficiency (SE) measured by polysomnography (PSG) after single and multiple~     dose administration to participants with insomnia disorder without psychiatric comorbidity.~   "
84267|NCT02464033|"~     The objectives of this study is to:~        -  Evaluate the tolerability of a combination therapy with Diamyd, vitamin D and etanercept~        -  Evaluate how the above mentioned treatments influence the immune system and endogenous~          insulin secretion~   "
84268|NCT02464020|"~     The goal of this study is to assess if oral vancomycin can restore the normal bile acid~     metabolism of people with Primary Sclerosing Cholangitis and Inflammatory Bowel Disease.~     Study participants will provide blood and stool samples in order to evaluate the bile acid~     metabolism before a short course of vancomycin and then again after to assess for change. The~     investigators will also assess the blood and stool of healthy people, and people with IBD~     (without PSC) as a control group.~   "
84269|NCT02464007|"~     In this EffTox dose escalation study, up to 3 dose levels will be tested. The optimal dose~     (OD) of rSIFN-co will be determined using the EffTox design. Additional subject cohorts will~     not be enrolled until all subjects at the current dose level complete 28 days without DLT.~     The optimal dose (OD) will be determined by evaluation of safety in each cohort and disease~     response by RECIST 1.1 at 8 weeks. Once the OD is determined, enrollment will continue until~     at least 9 subjects total are accrued at the OD. Pharmacokinetics of rSIFN-co will be~     conducted for all tested dose levels to characterize dose proportionality.~   "
84524|NCT02460666|"~     The purpose of this study is to evaluate the effects after 6 months of supervised weekly~     Tai-Chi-Chi versus Health Education and Wellness classes on reduction of depressive symptoms~     and improvement in resilience, health functioning, quality of life, cognition, sleep, fMRI~     neural correlates of working memory, and brain structure.~   "
84270|NCT02463994|"~     The purpose of this study is to find out whether a brief course of radiation therapy given to~     one area affected by the cancer will improve the chances of responding to immuno-therapy in~     the form of a medicine called MPDL3280A, an antibody against PD-L1. PD-L1 is expressed on~     lung cancers and is known to block the effects of the body's immune system in attacking the~     cancer. Blocking this PD-L1 has been shown to improve the body's immune cells to attack and~     kill the cancer cells in non-small cell lung cancer. The goal of this study is to see if~     prior treatment with radiation will allow improved recognition of the cancer by the body's~     immune cells in the presence of MPDL3280A.~   "
84271|NCT02463981|"~     The aim is to test whether rtfMRI-based neurofeedback training on anterior insula impacts~     pain empathy.~   "
84272|NCT02463968|"~     Chikungunya is a mosquito-borne viral illness that leads to chronic joint pain in~     approximately one half of patients. The mechanisms leading to long term arthritis in humans~     has not been well established. There is some evidence from animal studies that activated~     macrophages with persistent viral infection may play a role in chronic arthritis however~     these mechanisms have not yet been identified in humans. It is hypothesized that activated~     macrophages harboring persistent active chikungunya virus are responsible for chronic~     arthritis and joint pain in patients. The focus of this proposal is to evaluate synovial~     fluid and blood for direct viral persistence and activated macrophages that may clarify the~     mechanism of inflammatory injury. The results of this study will be directly applicable to~     tailoring trials of therapeutics.~   "
84273|NCT02463955|"~     EXPLORE is a first-in-human study of single port transdiaphragmatic thoracoscopy using a~     flexible gastro-intestinal endoscope under two-lung ventilation with controlled capnothorax.~   "
84274|NCT02463942|"~     In Slovenia, tick-borne encephalitis and Lyme borreliosis are both endemic diseases with high~     incidence rates and they are both transmitted by a bite of infected Ixodes ricinus tick. In~     clinical practice, tick-borne encephalitis is confirmed by demonstration of tick-borne~     encephalitis antibodies in serum of a patient with compatible clinical presentation and~     cerebrospinal pleocytosis. Patients with Lyme meningitis or meningoradiculitis also have~     cerebrospinal pleocytosis, however the presence of borrelial antibodies in serum does not~     attest Lyme neuroborreliosis.~      Patients with tick-borne encephalitis and positive borrelial antibodies in serum, but not~     fulfilling criteria for Lyme neuroborreliosis, are often being treated with antibiotics in~     several European countries due to the possibility of double infection. The investigators~     hypothesise that such patients do not benefit from antibiotics. Such an approach may appear~     safe regarding the possibility of borrelial infection, however it can also be associated with~     detrimental consequences such as antibiotic related adverse reactions, negative~     epidemiological impact on bacterial resistance, and intravenous catheter related~     complications.~   "
84275|NCT02463929|"~     The purpose of this study is to investigate the effect of diphenhydramine on the prevention~     of sevoflurane induced emergence delirium/ agitation in pediatrics. The Investigators~     hypothesis is that it reduce the incidence of sevoflurane induced emergence delirium/~     agitation.~   "
84276|NCT02463916|"~     The purpose of this study is too determine the effects of exercise on the gut microbiota and~     immunological markers in patients with inflammatory bowel disease and rheumatoid arthritis.~   "
84277|NCT02463903|"~     The purpose of the present study is to develop, implement and evaluate a stress management~     program aiming to improve emotional well-being, health-related quality of life and to reduce~     readmission to hospital in patients with chronic heart failure (CHF).~      Method: A randomized controlled study design will be employed in which the intervention~     consists of Coping Effectiveness Training (CET), a manual-based group intervention based on a~     cognitive transactional theory of stress and coping. The purpose of CET is to improve skills~     to appraise stress, teach a number of techniques to cope with stress, and to give an~     opportunity to interact with other people with similar experiences of living with CHF. The~     control group will receive standard health care. The intervention group will receive seven~     weekly sessions of CET. Self-assessments of; emotional well-being, depression and anxiety,~     illness perception, health-related quality of life, coping strategies and social support will~     be performed before the intervention, directly after the intervention, six weeks, six months~     and one year after the intervention period as well as measuring readmission to hospital. In~     addition, the participants in the intervention group will fill in an anonymous written~     evaluation, with closed and open ended questions, directly after the intervention.~   "
84278|NCT02463890|"~     Sleep apnoea affects more than 20% of people over 65 years and is largely underdiagnosed. It~     does multiply tenfold the occurrence of vascular events, particularly stroke. While~     Continuous Positive Airway Pressure (CPAP) is currently the Gold standard treatment to~     prevent cerebrovascular and cardiovascular events, with a major clinical benefit, long term~     adherence to CPAP is a significant problem and search for alternative treatment is essential.~      The investigators hypothesize that long-term exercise training would allow to reduce~     significantly sleep apnoea syndrome severity. Thus, in this study, the investigators will~     compare evolution of Apnoea Hypopnea Index (AHI) in an exercise trained group performed~     through in a national based non-profit organization (Fédération Française d'éducation~     Physique et de Gymnastique Volontaire (FFEPGV)) using a medical established program~     (NeuroGyV) during nine months against a control group receiving only standard dietetic and~     physical activity counseling.~   "
84279|NCT02463877|"~     The purpose of this study is to determine the feasibility of surgical techniques involving~     minimal entry into the living body approach for tumor reduction and treatment in which highly~     concentrated anticancer drugs are put directly into the abdomen through a tubes (HIPEC), and~     to determine if this approach may improve short-term postoperative outcomes, including the~     development of complications related to surgery within the first 30 days after surgery.~      Participation in this study is entirely voluntary. Approximately 30 subjects will take part~     in this single-center study and all will be enrolled at University of California San Diego.~   "
84280|NCT02463864|"~     This study will help to determine whether frail older medical inpatients will benefit from~     targeted exercise sessions performed twice daily while in hospital. Half of the patients will~     complete targeted strengthening, balance and endurance exercises and the other half,~     stretching and relaxation exercises. The exercise sessions will be assisted and supported by~     a senior physiotherapist.~   "
84282|NCT02463838|"~     This study will expand and evaluate an existing pilot program to improve care for frequent~     users of acute emergency and inpatient services by providing care coordination and management~     for eligible San Francisco Health Plan members. SF Health Plan's Community-Based Care~     Management pilot program (Program) known as CareSupport serves vulnerable SF Health Plan~     members who are high utilizers of hospital inpatient and emergency departments and at~     extremely high risk for mortality and morbidity due to factors such as housing instability,~     mental illness, and addiction. Care managers, called community coordinators, are trained~     bachelor-level social workers or outreach workers and each have a panel of 30-35 members who~     they directly engage in the community where the members tend to live or congregate (shelters,~     bus stops, coffee shops, community agencies, and by cell phone) to help them improve their~     health and navigate through the health care and social services systems. The number of San~     Francisco Health Plan members who would be eligible for Care Support services far outstrips~     the capacity the San Francisco Health Plan to provide these additional services, and the~     investigators will thus evaluate the intervention using a randomized trial design.~   "
84283|NCT02463825|"~     Amyotrophic lateral sclerosis (ALS) is a neuromuscular disease that results in rapid decline~     in normal muscle function and tone leading to difficulties with mobility, eating, drinking,~     breathing, sleeping, and communicating. The disease is progressive and no cure currently~     exists. Most people diagnosed with ALS succumb within 3 to 5 years. The only approved~     treatment to slow the progression of ALS is called Rilutek® (riluzole) which has only a~     modest effect and has been shown to increase survival by a few months.~      Muscular dysfunction present in people with ALS is caused by nerve breakdown and a~     dysfunction in the communication between the muscles and the nerves. The area where these~     communications occur is called the neuromuscular junction. Some recent studies have focused~     on using different medications to enhance communication at the neuromuscular junction with~     the goal of improving muscle function as a result. This approach is unproven but may help to~     slow the progression of the disease.~      Pimozide is a medication that has been demonstrated to enhance communication at the~     neuromuscular junction in fish and mice. This study will look at whether Pimozide may help to~     slow the progression of ALS and how much medication needs to be taken to have an effect.~   "
84284|NCT02463812|"~     Surgery puts a lot of stress on the body, and during recovery from surgery, the body uses a~     lot of energy to help with healing and getting stronger. Often, sugars are given before~     surgery to help give the body an energy boost. Lipid solutions can also be used as an energy~     source and are commonly used as supplements in patients needing long-term nutrition from an~     intravenous route (e.g., total parenteral nutrition) when they can not eat by mouth for a~     medical reason. Intralipid, a solution of lipid molecules from soybeans and eggs, is commonly~     used for patients who need nutrition and energy supplements. The investigators wish to test~     whether giving Intralipid immediately after surgery can improve recovery from major surgery.~   "
84285|NCT02463799|"~     This clinical trial studies the effect of radium-223 when added to sipuleucel-T for treating~     castrate-resistant prostate cancer that has spread to the bone. Sipuleucel-T is an autologous~     cellular immunotherapy designed to stimulate an immune response against prostate cancer. It~     has been suggested that the immune response may be strengthened by radiation therapy.~     Therefore this study is testing whether radium-223 added to sipuleucel-T increases the immune~     response and anti-tumor effect against prostate cancer.~   "
84286|NCT02463786|"~     Heart failure (HF) remains to have a poor outcome. Even though recent advances in HF led to a~     reduction of morbidity and mortality, improvement in outcome is much less than expected based~     on large randomized trials. Various reasons may be responsible, such as complexity of disease~     and comorbidities, inadequate diagnosis and inappropriate treatment. So far, little attention~     has been paid on patients seen in primary care. Also, HF care mainly focuses on the~     individual patient-doctor relationship. However, the increasing complexity prevents~     individual physicians from covering all aspects of care. Consequently, multiple stakeholders~     are involved, including both general practitioners and specialists. Still, the relative role,~     the interaction between them and the processes included are hardly defined. These aspects may~     not only be relevant for patient care, but also for the setup of health care systems. Whereas~     multidisciplinary team should resemble a seamless system across primary and hospital care,~     there is a scarcity of research considering how these disease management programs perform, in~     what form they should be offered, and what care and support patients and caregivers would~     benefit most.The INTERACT-in HF (Improving kNowldege Transfer to Efficaciously RAise level of~     Contemporary Treatment in Heart Failure) study is set up to determine and assess relevant~     factors of the quality of HF care. The study evaluates processes of HF care, role of relevant~     care givers and interactions between them. It collects data from individual patients to~     assess characteristics and management of contemporary HF patients. This is performed in~     different countries (the Netherlands, Belgium and Germany) to analyze decision making with~     respect to diagnostics and treatment.Cross-sectional mixed-methods are used. Patients and~     their caregivers are interviewed. The patient is the central starting point. Then, the~     treating GP, cardiologist and HF nurse are interviewed. In parallel, retrospective data based~     on records from these patients are reviewed to verify data from interviews and to determine~     characteristics of them. Retrospective data of additional patients are collected to complete~     the picture of the current situation. These data will be used to define bottlenecks that~     prevent best clinical practice to be used in daily care at all levels, comparing practice in~     different countries.Thus, the proposal aims to better understand HF care, which will lead to~     a better care and finally to improved outcome.~   "
84287|NCT02463773|"~     This is a proof of concept study where we aim to study the correlation between the use of a~     simple bedside ultrasound measurement of diaphragmatic muscle excursion with established (but~     time consuming) measurements made to optimize an important setting on the mechanical~     ventilator (positive end expiratory pressure or PEEP) in intubated adults with acute~     respiratory distress syndrome (ARDS) in the medical ICU.~   "
84288|NCT02463760|"~     The purpose of the study is to investigate imaging findings, which can help us to predict~     factors contributing to abdominal aortic aneurysm growth and rupture.~   "
84289|NCT02463747|"~     Neutropenic fever is a life threatening condition that is not rare in patients suffering from~     hematologic disorders, and of paramount importance to early and effective treatment. In this~     trial we concentrate on hospitalized patients with hematologic malignancies who develop~     neutropenic fever.~      In recent years, several studies were conducted to examine possible changes in the~     conventional empirical treatment, assuming that administration of the antibiotics in a~     prolonged infusion would allow for a greater fT > MIC that will lead to a better efficacy.~      These studies were carried out in different populations and there is only limited information~     about the importance of continuous infusion therapy in patients with hematologic diseases~     with neutropenic fever.~      Research goals: The main goal is to compare between two groups of hematologic patients with~     neutropenic fever, The first group will receive antibiotic therapy in extended infusion, and~     the second (control) group will receive the treatment in a fixed time.~   "
84290|NCT02463734|"~     The purpose of this research is to develop the DQoL-OC, a unique questionnaire to evaluate~     the quality of life of people aged 60 or above providing care for a family member with~     Alzheimer's disease or other related dementia at home in the UK.~      This questionnaire is aimed at allowing researchers, health and social professionals, as well~     as the older family carers themselves, to quantify the impact caring in different aspects~     life, for the purposes of economic evaluation or implementation and evaluation of~     interventions. The results from this study will also help us to understand better the aspects~     that affect carers' quality of life and well-being, which may guide future policies and the~     support provided to older family carers in the future.~      The DQoL-OC is being developed in two parts. The first part is now completed and was carried~     out through focus groups with older family carers for discussions about important aspects~     related to their quality of life and well-being in order to create the items of the new~     questionnaire. Its preliminary version contains 100 questions about the practical aspects of~     care and caregiving, carers' feelings and concerns and satisfaction with life and with the~     caring role.~      The second part of the DQoL-OC development is currently being carried out and aims to~     evaluate its validity and reliability for use with older family carers and to reduce it into~     a smaller number of items. About 300 older family carers are invited to answer individually~     the DQoL-OC and other similar questionnaires for these purposes. About 25 participants taking~     part in this study are invited to answer the same questions with an interval of two weeks in~     order to allow us to compare the results and its stability over this period of time.~   "
84291|NCT02463721|"~     Several studies have pointed out changes in the epidemiology of the causative bacteria in SBP~     and bacterascites and in their susceptibility to antibiotics. In particular, the development~     of beta-lactamase enzymes, which confer resistance to clavulanate, or extended spectrum~     beta-lactamases in Escherichia coli. The potential emergence of enterococci,~     methicillin-resistant S. aureus, or fluoroquinolone-resistant bacteria, following norfloxacin~     prophylaxis, is also a cause of concern since they may be associated with a higher risk of~     therapeutic failure.~      The microbial etiology of SBP remains relatively constant; however, the antibiotic resistance~     rate especially for third-generation cephalosporins (including cefotaxime and ceftazidime),~     ciprofloxacin, and ofloxacin increased dramatically~   "
84292|NCT02463708|"~     This project will conduct a retrospective clinical database review and a one-time research~     interview to evaluate outcomes among a sub-set of caregivers (CGs) who were enrolled in the~     Behavioral Health Laboratory (BHL) Caregiver Outreach and Telehealth Education Program~     (COTP). The investigators will recruit CGs whose Care Recipients (CR) met criteria for~     clinically significant cognitive impairment and/or dementia and who received care management~     services through the COTP.~   "
84293|NCT02463695|"~     The pathophysiology of vertigo is complex and usually requires specialist involvement. During~     the diagnostic process, patients commonly undergo tests which assess the integrity of the~     gaze and posture stabilisation mechanisms involving the inner ear (vestibular system), the~     visual systems and the subconscious neural pathways that interconnect them. Whilst these~     tests are useful they fail to provide information concerning the neural connections to the~     cortex and therefore neglect the perceptual aspects of disequilibrium.~      At present the possibility of routine examination of these higher projections remains elusive~     as no practical alternatives to the expensive functional magnetic resonance imaging systems~     exist. However, recently a novel method of recording cortical vestibular evoked potentials~     (CVEPs) has been described.~      CVEPs utilise an existing method used to interrogate cortical projections from the auditory~     system in which sound waves stimulate the inner ear and the resulting electrical responses~     from the brain are recorded. The recent breakthrough is in the realisation that these~     responses also contain information from the balance organs and therefore are a direct measure~     of cortical processing of the vestibular inputs.~      Current evidence shows that CVEPs are present in the normal population and absent in patients~     with no vestibular function. The primary aim for this study is to extend the patient cohort~     to include those who have a vestibular injury but retain residual function. Patients going~     through standard testing will have also have CVEPs on both ears providing seminal information~     into the effect of injury to the peripheral vestibular system on the cortical pathways.~     Furthermore, by following the cohort through their complete management pathway it will be~     possible to ascertain if the CVEP can be used to predict rehabilitation outcome success.~   "
84294|NCT02463682|"~     This is a feasibility study of an artificial pancreas (AP) system with our previously~     validated Zone-MPC and Health Monitoring System (HMS) algorithms (ClinicalTraisl.gov:~     NCT01929798) integrated into the Diabetes Assistant (DiAs) system.~   "
84295|NCT02463669|"~     The purpose of this study is to determine if splenomegaly on point-of-care ultrasound (POCUS)~     is an accurate and user-friendly surrogate to the heterophile antibody test and Epstein-Barr~     Virus (EBV) serologies to diagnose acute mononucleosis infection in patients presenting with~     sore throat to the Emergency Department (ED).~   "
84296|NCT02463656|"~     Focal dermal hypoplasia (FDH) is a rare genetic disorder of ectodermal dysplasia caused by~     mutation in the Porcupine Homolog (Drosophila) (PORCN) gene which results in skin, hair, limb~     and eye abnormalities. Short stature and underweight have been noted in the majority of these~     patients. Since the pituitary gland arises from ectodermal tissue, the investigators suspect~     that pituitary deficiencies may contribute to poor linear growth. This study will examine the~     nutritional, gastrointestinal and endocrine mechanisms that may account for linear growth~     stunting and low weight that is observed in FDH. The investigators will utilize standard~     clinical tools including a bone age xray, glucagon stimulation test to evaluate growth~     hormone status, baseline laboratory analysis of hormone and nutritional/gastrointestinal~     markers, food diaries, symptom diaries, and growth charts.~   "
84297|NCT02463643|"~     The purpose of this study is to evaluate the efficacy and safety of Z-215 (10 mg, 20 mg, 40~     mg) , compared with Rabeprazole Sodium 10mg in patients with erosive esophagitis of Grade A~     to D as defined by the LA classification grading system.~   "
84298|NCT02463630|"~     Posterior compression - distraction reduction technique （CDR） in the treatment of Basilar~     invagination associated with atlantoaxial dislocation~   "
84299|NCT02463617|"~     This study aims to characterize the nature of impulsivity in Parkinson's Disease (PD).~   "
84300|NCT02463604|"~     This study evaluates the efficacy of remote ischemic preconditioning on preventing contrast~     medium-induced nephropathy in a population of high risk patients undergoing coronary~     angiography. Half of participants will receive a preconditioning procedure while the other~     half will receive a sham procedure.~   "
84301|NCT02463591|"~     The purpose of this study is to investigate whether Prothrombin Complex Concentrate (PCC) is~     effective in reversing the anticoagulant effect of Dabigatran, as assessed by two modified~     skin-bleeding tests.~   "
84302|NCT02463578|"~     Exploratory study of anti-pneumococcal immune response in patients with Anti-neutrophil~     cytoplasmic antibody (ANCA)-associated vasculitis (AAV) immunized according to new vaccine~     recommendations (i.e. with a combined vaccine schedule (13-valent conjugate pneumococcal~     vaccine -PCV13- followed by a 23-valent non-conjugate pneumococcal vaccine -PPV23- 8 weeks~     later).~   "
84303|NCT02463565|"~     Food provision and consumption were assessed for all hospitalized patients over a 24h-period~     survey. This study is a part of a control quality programme and is performed every 4 years~     since 1999.~   "
84304|NCT02463552|"~     This study aims to evaluate the effects of prior use of non-steroidal anti-inflammatory~     Naproxen on risk and level of tooth sensitivity caused by in-office bleaching procedures.~   "
84305|NCT02463539|"~     Descriptive study of the residual anti-pneumococcal immunity in patients with Anti-neutrophil~     cytoplasmic antibody (ANCA)-associated vasculitis (AAV) who have previously gone through~     pneumococcal immunization.~   "
84306|NCT02463526|"~     Participants will be initially assessed for their suitability for inclusion in the study and~     will undergo a physical screening of the affected shoulder and cervical spine by an~     experienced physiotherapist. After, participants will be attended 72 hours after data~     recording of the baseline measures (range of motion with a goniometer, pressure pain~     threshold with a algometer, and peak force with a dynamometer) for four sessions per week~     with 24 hours of interval between sessions. At each experimental week session, each~     participant will receive one of the two treatment conditions (MWM or sham) and then will~     repeats the assessment. In the following week, there will be a crossover condition of each~     individual and 24 hours after the last treatment session, the examiner will do the last~     assessment.~   "
84307|NCT02463513|"~     Approximately 10% of the world's population have a particular genetic makeup (known as the TT~     genotype) that may increase their risk of having higher blood pressure. Previous work~     conducted by the investigators research group at the University of Ulster, in collaboration~     with clinical colleagues from across Northern Ireland, in premature CVD patients and~     hypertensive adults generally has demonstrated that a dietary level of riboflavin (1.6mg/d)~     decreases blood pressure, specifically in those with the TT genotype. To date, the blood~     pressure lowering effects of higher doses of riboflavin in individuals with the TT genotype~     is not known. The aim of this study is to investigate whether supplementation with riboflavin~     at a low dose supplemental level (10mg/d) can decrease blood pressure more effectively than~     the dietary level (1.6mg/d) by optimising riboflavin status and normalising MTHFR activity.~     This aim will be achieved by conducting a double-blind placebo-controlled intervention study~     over a 16 week period.~      Participants will be recruited from cohorts screened for the methylenetetrahydrofolate~     reductase (MTHFR) C677T polymorphism. Those identified with the TT genotype (homozygous for~     the polymorphism) that wish to participate in this research will be asked to attend a~     baseline and week-16 appointment and will be asked to take a daily riboflavin (1.6 or 10mg/d)~     or placebo capsule for the duration of the study. At each appointment a blood sample will be~     taken and blood pressure, height, weight and waist circumference will be measured. If the~     results of this study show that intervention with a higher dose of riboflavin can lower blood~     pressure more effectively in individuals with the TT genotype this will have important~     implications for those responsible for the management of blood pressure. The findings will be~     of particular relevance in populations with a higher prevalence of the polymorphism.~   "
84308|NCT02463500|"~     This will be a continuing, prospective study of diabetic foot ulcers and infections, risk~     factors and clinical outcomes and a limited data set conducted by the investigator through~     the establishment of a data and tissue repository in the uT Southwestern Department of~     Plastic Surgery. in addition, subjects consented for this research will be asked about~     inclusion in a recruitment database to be used in the recruitment of subjects for future~     research on diabetic foot complications.~      about 250 patients are seen for diabetic foot ulcers and infections each year.~   "
84309|NCT02463487|"~     The investigators plan a randomized clinical trial of 150 patients with infected~     diabetes-related lower extremity wounds to compare the clinical and economic effectiveness of~     negative pressure wound therapy with continuous irrigation and negative pressure wound~     therapy without irrigation.~   "
84310|NCT02463474|"~     This research study will test whether a series of video clips with breast cancer information~     improves knowledge of breast cancer, breast cancer treatment and living with breast cancer.~     Questionnaires will be completed to learn if the videos are helpful and pleasant to watch.~   "
84311|NCT02463461|"~     The primary objective of the proposed study is to investigate the agreement levels of modern~     and well-established actigraphy devices against PSG in healthy as well as patient populations~     for multiple sleep parameters across two study sites (Qatar and New York City).~   "
84312|NCT02463448|"~     This is a prospective, open-label, Phase 1, single center study evaluating the safety and~     efficacy of Autologous Muscle Derived Cells as a treatment for chronic Underactive Bladder.~   "
84313|NCT02463435|"~     Obesity is a worldwide epidemic with increasing prevalence, specially severe obesity (Body~     Mass Index (BMI) ≥ 35 kg/m2). It is a multifactorial disease that involves genetic and~     environmental factors that lead to increased mortality from cardiovascular disease, diabetes,~     cancer, among others and impairs life quality. Most research on severe obesity focuses on~     surgical alternatives and their results, thus this clinical trial aims to evaluate the effect~     of a non-pharmacological approach based on nutritional intervention and supplementation with~     a functional food, the olive oil. It will analyze the effectiveness of interventions on:~     weight loss, improvements on body composition and inflammatory profile (TNF-alfa,~     interleucins 1, 6 and 10, adiponectin), insulin resistance and serum lipids control, changing~     eating habits and physical activity practice, modification on bone mineral density and~     sarcopenia, and reduction of cardiovascular risk and other diseases. Also, it will be~     investigated the influence of polymorphisms (Pro12Ala of PPAR-γ gene, -174G>C of IL6 gene e~     Trp64Arg of ADRB3 gene) on nutritional intervention effectiveness with and without olive oil.~     This research looks for improving severely obese patient's care and contributing to effective~     results by reducing costs and risk treatment. The investigators believe that this~     informations will contribute significantly to the scientific field, expanding the knowledge~     about severe obesity.~   "
84334|NCT02463149|"~     This project examined the effectiveness of Youth Chef Academy (YCA), a classroom-based~     experiential culinary and nutrition literacy curriculum for middle-school students. The~     primary study hypothesis was that students assigned to YCA would demonstrate greater~     improvement in F/V and whole grain consumption compared to students in the control group.~     Eight classrooms in eight public K-8 schools participated in the project. Classrooms were~     assigned to intervention or control condition in a non-randomized manner. YCA was delivered~     by project staff to all of the students in the four intervention classrooms. Students~     completed a survey to assess primary and secondary outcomes at baseline, six-week curriculum~     completion, and at twelve-week curriculum completion (YCA extended twelve-week curriculum~     cohort).~   "
84314|NCT02463422|"~     According to a recent report from the Centers for Disease Control, most children with ASD do~     not receive a diagnosis and begin receiving treatment until well after their 4th birthday,~     which is unfortunate given that many connections between brain cells have already been~     established by that age. This program will test a model called Get S.E.T. Early (S=Screen,~     E=Evaluate, T=Treat) in both San Diego and Phoenix, designed to detect, evaluate, and treat~     ASD within the first 2 years of life. In this proposal 7,500 toddlers from the general~     population will be screened in San Diego and Phoenix (total 15,000) using the CSBS IT~     Checklist (Wetherby & Prizant, 2002) at well baby check-ups using a triple screen approach~     wherein toddlers are screened at three ages starting at 12 months. Investigators predict that~     providing screening tools with clear cut-off scores and guidelines for automatic referral for~     both evaluation and treatment will result in dramatically lowering mean age of detection in~     Phoenix from 4-5 years down to 1-2 years. Investigators also predict that using repeat~     screening at 12, 18, & 24 months in combination with automatic referral options via~     technology (i-Pads) will result in an increase in the number of ASD toddlers detected by 24~     months relative to a single time point screen using traditional paper screens.~   "
84315|NCT02463409|"~     This study will test an investigational drug, theophylline, in children with~     pseudohypoparathyroidism type 1a (PHP1a). This study involves a 3 day visit to the Vanderbilt~     Clinical Research Center.~   "
84316|NCT02463396|"~     The primary aim of this study is to investigate clinical effectiveness of mindfulness~     training versus treatment as usual (TAU) in adults with Attention Deficit Hyperactivity~     Disorder (ADHD). The secondary aim is to assess whether mindfulness training is~     cost-effective compared to TAU in adults with ADHD from a societal perspective.~   "
84317|NCT02463383|"~     Postmenopausal women, stratified by a peroxisome proliferator-activated receptor gamma-2~     (PPARG) polymorphism, were given the following treatments in a random order with a 5w~     wash-out period: a 400mg ibuprofen tablet or a placebo tablet; both treatments were followed~     after 30min by a single acute dose of 0.4g alcohol per kg bw. Serum estrogen levels were~     measured before and at three timepoints after alcohol intake. It is hypothesized that the~     acute decrease in estrogen sulphate and other markers of estrogens after alcohol intake is~     modulated by ibuprofen and by PPARG genotype.~   "
84318|NCT02463370|"~     Submucosal resection of the nasal septum (SMR) could be performed under local anesthetic~     infiltration performed through ten injections in addition to general anesthesia which was~     associated with less postoperative pain and shorter hospital stay.~      However, the local infiltration technique is time-consuming and requires a large number of~     facial injections. This gave rise to the idea of reducing the number of injections while~     retaining the effectiveness of the local anesthetic technique.~      Decreasing the number of injections could be achieved by blocking the superior maxillary~     nerve (V2) and the infra-orbital nerve since it would result in anesthetizing the surgical~     area as well after induction of general anesthesia.~      The purpose of this prospective double-blind clinical trial was to compare the effectiveness~     of four versus ten local anesthetic injections in terms of postoperative pain relief. The~     secondary objective was to compare patients' and surgeons' satisfaction between the two~     techniques.~   "
84319|NCT02463357|"~     Acute Mountain Sickness (AMS) is a well-documented syndrome that affects 42% of~     non-acclimatized individuals traveling to altitudes above 10,000 feet. Decreased barometric~     pressure, which leads to low blood oxygen levels, is the primary casual factor of AMS.~     Symptoms of AMS are characterized by headache, nausea, vomiting, dizziness, fatigue and~     difficultly sleeping. Moreover, when people travel to high altitude, cognitive performance~     and endurance exercise capacity are impaired. Therefore, the goal of this research is to~     identify effective pharmacological agents that will help reduce the symptoms of AMS and~     improve physical and cognitive performance at high altitude.~      The investigators will study the efficacy of the dietary supplement, quercetin, the drugs~     nifedipine (extended release) and methazolamide taken together, the drug metformin, and the~     drug nitrite in reducing symptoms of AMS and improving cognitive and exercise performance at~     high altitudes.~   "
84320|NCT02463344|"~     The purpose of his study is to evaluate the long term safety and tolerability of MA09-hRPE~     cellular therapy in patients with advanced dry Age-Related Macular Degeneration (AMD) from~     one to five years following the surgical procedure to implant the MA09-hRPE cells.~   "
84321|NCT02463331|"~     The gold-standard treatment of Autoimmune hepatitis (AIH), with prednisone alone or in~     conjunction with azathioprine can reach resolution of the disease in 70-80% of the cases in~     US. However, in Brazil the response to these treatments seems to be worse, approximately 35%~     in five years. Because of the side effects of the gold-standard treatment and the need for an~     alternative option for the no responsive patients, news drugs must be evaluated for this~     proposal. Chloroquine diphosphate is an antimalarial drug that has been used for the~     treatment of rheumatological diseases for at the least five decades. Chloroquine was used as~     a single drug for up to two years for the maintenance of AIH remission in an open study.~     There was a 6.49 greater chance of relapse in the historical controls when compared with~     patients treated with chloroquine (72.2% x 23.5%; p = 0.031). The aim of this study was to~     investigate whether chloroquine in conjunction with prednisone can be used as an alternative~     treatment of AIH in a randomized study, and to evaluate its side effects.~   "
84322|NCT02463318|"~     The purpose of this study is to investigate the gene expression and activity of SIRT1, and~     forkhead box O3 pathway by means of investigating target genes MnSOD and catalase in multiple~     sclerosis and healthy subjects. Also, we investigate the effect of melatonin on interaction~     between SIRT1 activity and target genes MnSOD and catalase in multiple sclerosis and healthy~     subject .Additionally, we evaluate effect the probable effect of melatonin treatment on gene~     expression and activity of above-mentioned genes in peripheral blood mononuclear cells of~     healthy subjects-treated with H2O2.~   "
84323|NCT02463305|"~     This study plans to learn more about the effects that creatine monohydrate has on disease~     activity in ulcerative colitis. Creatine is a substance that is naturally produced by the~     body and is found in foods, such as meat and fish. Creatine helps to provide energy to some~     body tissues, such as the colon. In the colon, this energy allows cells to form a tight~     barrier between molecules in digested food and bacteria and the body's infection-fighting~     cells within the colon underneath this barrier. If the barrier becomes leaky molecules may~     pass through and lead to inflammation. This leakiness may contribute to the colon~     inflammation seen in ulcerative colitis.~   "
84324|NCT02463292|"~     This study aims to evaluate the psychosocial situation of adult congenital heart disease~     (CHD) patients in terms of health-related quality of life, mental health, academic~     achievement, and employment status. By assessing a wide variety of medical (e.g., disease~     severity) and psychosocial (e.g., life events, coping strategies, personality) risk factors~     it will be possible to better understand the variables that influence psychosocial outcome of~     young adults with congenital heart disease. This will further improve the understanding of~     the lifelong consequences of a congenital heart malformation. Factors that proof to be~     predictors of favorable outcome represent a resource of resilience and therefore should play~     an important role in the care of CHD patients. By implementing those results in patient care~     the investigators aim to achieve an improved psychosocial outcome among adult congenital~     heart disease (ACHD).~      Hypothesis 1: It is expected that perceived health status, health-related quality of life and~     psychological adjustment will not differ between the patient and the control group. However,~     academic achievement and employment status are expected to be poorer in young adults with~     congenital heart disease compared to healthy controls.~      Hypothesis 2: It is assumed that parental socioeconomic status, problems in emotional~     regulation and impaired social support will be related to a negative psychosocial outcome and~     health-related quality of life. Moreover, the investigators hypothesize that disease severity~     is associated with academic outcome and employment status.~   "
84325|NCT02463279|"~     The goal of this study is to evaluate basic usability and confirm expected safety and~     effectiveness of SinuSys Dilation System when used to dilate frontal recess and sphenoid~     sinus ostia in patients with chronic rhinosinusitis.~   "
84326|NCT02463266|"~     The SUpporting Seniors Receiving Treatment And INtervention (SUSTAIN) program is a~     telephone-based clinical service designed to help identify and manage behavioral health~     issues among PACE/PACENET enrollees. The purpose of the current project is to a) explore~     moderators of treatment response among beneficiaries in the SUSTAIN Clinical Program and b)~     to evaluate the sustained clinical effects of the program.~   "
84327|NCT02463253|"~     This is a single-center, prospective, non-randomized, observational study to evaluate~     specific proteogenomic biomarker panels for acute rejection (AR) and chronic allograft~     nephropathy/interstitial fibrosis and tubular atrophy (CAN/IFTA) in blood, urine and kidney~     tissue (biopsy) in kidney transplant recipients. Proteogenomic profiles will be routinely~     monitored over one year after enrollment.~   "
84328|NCT02463227|"~     The purpose of this study was to evaluate the safety, tolerability, pharmacokinetics (PK),~     and antiviral activity of an antibody (called VRC01) in HIV-infected adults whose HIV was~     well-controlled with HIV medicines. The study examined whether VRC01 controlled or delayed~     the return of HIV viremia when the participants' HIV medicines were briefly stopped during~     the study.~   "
84329|NCT02463214|"~     This study involves sampling bone marrow transplant patients, hospital workers and the~     patient room for microbes using swabs and other techniques. We send these samples to the~     laboratory, where they will use state-of-the art technology to identify and relate the~     microbes to each other. This study also involves putting copper, nickel, or titanium into~     some hospital rooms, and seeing whether these metals influences the growth of microbes. Some~     equipment in the hospital room, such as faucets and soap dispensers will be replaced by~     sensor-based (e.g. touchless) controls.~   "
84330|NCT02463201|"~     The prevalence of childhood obesity has increased at an alarming rate over the last decades,~     both globally and in Denmark. There are a number of serious sequelae related to obesity, such~     as hypertension, hypercholesterolemia, fatty liver and prediabetes. Obesity is found to be a~     risk factor for obstructive sleep apnea (OSA). OSA in childhood is known to be associated~     with cardiovascular complications, neurocognitive problems and reduced quality of life. The~     correlation between obesity and OSA is still poorly understood. Early detection and~     intervention is of great importance as the health consequences related to OSA as well as~     obesity are severe. Adenotonsillectomy is recommended as first-line therapy in children with~     OSA. However, only around 25% of obese children benefit from this treatment compared to~     around 75% of normal-weight children suggesting that there might be other structural factors~     predisposing to OSA in obese children.~      In this study the investigators aim to clarify the impact of obesity in the development of~     OSA. The prevalence of OSA in obese children will be investigated. Furthermore the purpose is~     to assess the effect of weight loss on OSA.~   "
84331|NCT02463188|"~     The goal is to adapt and refine an innovative, developmentally-appropriate universal health~     promotion intervention to reduce insufficient sleep among adolescents aged 14 to 16, while~     engaging teens in the adaptation process to maximize the relevance, appeal, and effectiveness~     of the program for diverse school settings.~   "
84332|NCT02463175|"~     Surgery for scoliosis correction, the abnormal curvature of the spine, is a major procedure~     often undertaken in adolescents. In adult anesthesia, there is a large volume of literature~     debating how to optimize fluids administered during surgery, as both too much fluid and too~     little fluid are associated with worse outcomes. The investigators will compare fluid~     administration based on the measured amount of blood pumped by the heart during each heart~     beat (goal-directed therapy), against standard anesthetic management. The main outcomes are~     a) post-surgical kidney dysfunction, b) prevalence of intraoperative hypotension, c) volumes~     of administered fluids, and d) length of hospitalization.~   "
84333|NCT02463162|"~     The Canadian population is aging and more people are living with advanced chronic diseases.~     At the end of life (EOL), the use of invasive medical treatments in hospitals is increasing~     and associated with worse outcomes. Advance Care Planning (ACP) may help improve care at EOL~     to be the way patients want it. ACP is a process where people think about the various options~     related to future health care decisions and they may communicate with a verbal or written~     plan of what care they would want in the EOL. Also, they may nominate a substitute decision~     maker if they become unable to speak for themselves. A national poll found that few Canadians~     have thought about or made an ACP.~      Alberta Health Services has developed two videos (Videos) to help with decision making about~     ACP and goals of care designations(GCD). GCD are medical orders of care that (a) serve as a~     communication tool for HCP to assist in rapid decision making; and (b) guide HCP and patients~     regarding the general intent and locations of care, and interventions that are to be~     provided. This study will compare ACP behaviours and GCD preferences for participants who~     have seen the Videos with those who have not and measure the change in those behaviours and~     preferences at 1, 2 and 3 months. It will also look at the impact of the Videos on health~     care costs and service use. Participants from five patient groups (metastatic lung cancer,~     colorectal cancer, gynecological cancer, renal failure, and heart failure) were selected as~     representative of where ACP should ideally be occurring, and where data on ACP implementation~     is presently most lacking, and as venues in which this research is most feasible. Collecting~     information about patients' ACP and GCD preferences may help improve AHS decision making~     tools and more generally help healthcare leaders plan ways to better engage patients in the~     ACP process.~   "
84335|NCT02463136|"~     Adolescents are particularly vulnerable to psychological problems, partly because of dramatic~     changes in the brain, along with changes in social interactions patterns as they move from~     childhood towards adulthood. One of the most common problems is anxiety, which affects up to~     1 in 4 adolescents. Moreover, paediatric anxiety predicts lifelong persistent mental health~     problems, which are estimated to cost the UK taxpayer £8.6 billion annually. Young people~     with anxiety experience intense fears and worries, leading to problems with friendships, poor~     school performance, and long-term mental health difficulties. Research investigating how and~     why some young people develop anxiety is therefore critically needed so that strategies for~     early intervention can be developed.~      This research will test the hypothesis that using a novel training intervention, - which~     teaches participants to change the way that their brain responds to emotional stimuli - will~     allow the investigators to influence response strategies while they are being established and~     possibly reduce the risk for anxiety in the long run. To achieve this, the investigators will~     test 50 adolescent females (aged 14-17 years) varying in anxiety levels to investigate~     whether brain responses in emotion regulation regions can be up/down regulated using~     fMRI-based neurofeedback.The rationale behind this research approach is that successful~     changes in brain response may then provide the participant with an additional, 'bodily'~     feeling of how respond to an emotional stimulus in real life situations, thereby paving the~     path towards the development of effective, age-appropriate intervention approaches.~   "
84336|NCT02463123|"~     Estimation of energy requirements is essential for adequate nutritional support in ICU.~     Indirect calorimetry being the golden standard of resting energy expenditure estimation is~     not available in most intensive care units. Different predictive equations have been~     developed, but not evaluated in cardiac population and have low accuracy in compare to the~     indirect calorimetry. The aim of present study is to develop cardio-specific equation for~     resting energy expenditure estimation.~   "
84337|NCT02463110|"~     Primary purpose:~      To evaluate the evolution in time of the antiaggregant platelet effect of sertraline (SSRI)~     compared to placebo in depressive patients with ACS (Acute Coronary Syndrome) and treated as~     recommended by a double antiplatelet therapy, aspirin and clopidogrel.~      Hypothesis:~      The benefits of SSRIs observed in depressive patients with ACS are related to an antiplatelet~     effect.~   "
84338|NCT02463097|"~     This study is a single-arm, multi-center, Home and Hotel Clinical Investigation in subjects~     with type 1 diabetes on insulin pump therapy. The purpose of this study is to demonstrate~     that the closed loop algorithm that is built into the 670G insulin pump is safe as part of~     the overall system.~   "
84339|NCT02463084|"~     This study compares the effects of a one-month diet high in saturated fat (SF), glycemic~     index (GI), and salt (Na+) to a diet low in these nutritional parameters on memory and other~     cognitive functions, on MRI measures of brain structure, function, and perfusion, as well as~     on blood and cerebrospinal fluid levels of amyloid-beta (Aβ), insulin, lipids (total~     cholesterol, HDL, LDL, oxidized LDL, and triglycerides), cytokines, apolipoprotein E (ApoE),~     apolipoprotein J, cortisol, soluble low density lipoprotein receptor-related protein (sLRP),~     and glucose in middle-aged adults (45-65 years of age) with normal cognition or mild~     cognitive impairment.~   "
84340|NCT02463071|"~     This study is a randomised, double-blind phase III long-term study to evaluate efficacy and~     safety of 12 weeks and 52 weeks of AZD0585 administration compared to placebo in patients~     with hyperlipidemia accompanied by hypertriglyceridemia .~   "
84341|NCT02463058|"~     Israel ministry of defense is examining a new protective undergarment of GORE company~     (chempark fabric) for the police forces. The goal of this research is to perform a~     comparative experiment in order to evaluate the physiological strain induced by a BC~     protective undergarment under exercise-heat stress conditions.~   "
84342|NCT02463045|"~     This study evaluates the safety and tolerability of TOP1288 rectal single and multiple~     ascending doses in healthy subjects and multiple doses in subjects with ulcerative colitis.~   "
84343|NCT02463032|"~     The purpose of this study is to determine if GTx-024 at different dosages (9 mg or 18 mg) is~     effective and safe in the treatment of patients with metastatic or locally advanced ER+ and~     AR+ breast cancer in postmenopausal women.~   "
84344|NCT02463019|"~     This open-label study is an roll-over extension of a randomized trial Efficacy of Tenofovir~     Disoproxil Fumarate in Chronic Hepatitis B Patients with High Viral Load but Slight~     Aminotransferase Elevation (NCT01522625).~      After finishing the 3-year therapeutic trial, all patients receive open-label TDF for another~     3 years. All patients undergo liver biopsy to evaluate the stage of fibrosis after the 3-year~     open-label therapy. During the 3-year period, patients were followed up every 12 weeks for~     the biochemical, serological, virological parameters, and adverse reactions.~      The primary outcome is the progression of liver fibrosis. Safety issues such as change of~     renal function and bone mineral density are 2nd outcomes.~   "
84345|NCT02463006|"~     Till date, no study has been reported in the literature where porous bioactive glass was used~     for the management of periodontal osseous defects. In this context, the present study is~     designed to assess the efficacy of the porous variant of bioactive glass and compare with~     that of nonporous variant using cone beam computed tomography.~   "
84346|NCT02462993|"~     Background: Aloe vera is considered to be the most promising and high-ranking agent as an~     all-purpose herbal plant amongst herbal agents used in dentistry. This study was designed to~     evaluate the clinical and microbiological effectiveness of locally delivered aloe vera gel as~     an adjunct to scaling and root planing in the treatment of chronic periodontitis.~   "
84347|NCT02462980|"~     Use of the AcQMap High Resolution Mapping and Imaging System to map persistent atrial~     fibrillation to identify potential mechanistic targets for ablation.~   "
84361|NCT02462798|"~     Iron deficiency anaemia is a major problem for women worldwide. Cereal foods are a major~     source of iron, but much of this is not bioavailability due to it being bound by the high~     amounts of phytate present in cereals. Destruction of phytate by the phytase enzyme can~     release iron and increase its bioavailability. In a human cell model of iron uptake,~     sourdough fermentation, which included activation of phytase, the enzyme that breaks down~     phyate, led to improved iron bioavailability. This clinical trial will attempt to demonstrate~     that this concept also works in humans~   "
84348|NCT02462967|"~     Study GT 026 is a Phase 2, multicenter, parallel group, North American, randomized, placebo~     controlled, double blind study. This study will enroll subjects with portal hypertension~     (HVPG greater than or equal to 6 mm Hg) who also have a liver biopsy with cirrhosis (Ishak~     stage 5 or 6), presumably due to NASH, excluding subjects with medium and large varices and~     those with decompensated cirrhosis.~      Subjects with portal hypertension and cirrhosis will be randomly assigned (1:1:1 ratio) to~     receive 1 of 3 treatment assignments including placebo, GR MD 02 in a dose of 2 mg/kg lean~     body mass, or GR MD 02 in a dose of 8 mg/kg lean body mass administered every other week over~     a 52 week period for a total of 26 intravenous infusions. The primary endpoint analysis is~     the baseline adjusted change in HVPG at 1 year (53 55 weeks) in subjects treated with placebo~     as compared to subjects treated with GR MD 02 (2 mg/kg/week or 8 mg/kg/week).~      An esophagogastroduodenoscopy (EGD) with evaluation for varices, HVPG, and liver biopsy will~     be performed before the first infusion and after the final 26th dose of IMP. Additionally,~     subjects will undergo a FibroScan (if available) prior to the first infusion, at Infusion~     Visit 13, and 14 to 28 days following final 26th infusion, an MBT (if available) will be~     performed at screening, at Infusion Visit 13, and 14 to 28 days after the final infusion, and~     blood will be collected for assessment of biomarkers.~      All subjects are to attend 2 postdose visits: the first will occur 14 to 28 days after the~     final dose administration and a second will occur 14 days following the first postdose visit.~      Subjects will be offered enrollment into a subsequent separate study, an open label extension~     study, if there is adequate tolerability and no safety issues or signs of clinical~     progression that would recommend discontinuation.~      Subjects who do not enroll in the open label extension study will be contacted via telephone~     every 6 months for 2 years and annually thereafter for a total of 4 years.~   "
84349|NCT02462954|"~     The purpose of this study is to evaluate the safety of ContraGel versus the~     hydroxyethylcellulose (HEC) Universal Placebo gel when used with the Caya diaphragm during~     two 7-day periods of daily use, the first without intercourse and the second with~     intercourse.~   "
84350|NCT02462941|"~     Heart transplants save the lives of nearly 500 children in heart failure per year. Columbia~     is one of the largest pediatric heart transplant centers in the world, averaging 25~     transplants per year, and providing ongoing care to nearly 250 children with transplanted~     hearts. After transplant, children are at increased risk to develop sudden onset of~     abnormally fast heart rates. This research project will study adenosine, a medication that is~     routinely used to slow fast heart rates in non-transplanted children (i.e. normal hearts),~     and its effects on the transplanted heart. Adenosine is often not used in patients with~     transplanted hearts because, based on prior limited research in adult patients, the standard~     adult dose may have a longer medication effect, producing a slower heart rate for an~     undesirable period of time. However, the current alternatives to adenosine treatment are~     either inappropriate for the pediatric age range, or have increased risk of unwanted side~     effects. This research project will answer two questions: is adenosine safe to give a child~     who has had a heart transplant, and will it be effective in treating the fast heart rate?~      All pediatric heart transplant patients undergo regular heart testing, known as a cardiac~     catheterization, one or more times per year. Three days before testing, participants will be~     asked to stop a regular medication, dipyridamole, because it slows the breakdown of adenosine~     in the body, and may increase its effects. (Of note, all patients that are on dipyridamole~     are also on aspirin, which gives a second line of heart protection, and will not be stopped.)~     After regular cardiac catheterization, all patients will already have intravenous (IV) access~     to give medication. Also, this setting allows the opportunity to have a back-up pacing~     catheter in the heart, ensuring that there will not be a longer than desired effect from the~     medication. Adenosine will be given per a low-dose protocol until either the medication~     effect is seen or the maximum dose is reached. There will be no difference in procedure~     recovery period time, and patients will resume regular home medications after finishing the~     test. As Columbia is one of largest pediatric heart transplant centers in the world, studying~     the effects of adenosine at low doses will benefit the investigators population greatly,~     either to find a new recommended medication dose, or to provide evidence that this medication~     is truly inadvisable for the investigators patients.~      The initial study was completed with all 80 patients enrolled and tested. Subsequent testing~     is now ongoing on patients in whom dipyridamole was stopped prior to their initial testing~     with a repeat study without discontinuing the dipyridamole. We anticipate re-testing about 30~     of the 80 patients.~   "
84351|NCT02462928|"~     This is a safety and efficacy study of abicipar pegol in patients with neovascular~     age-related macular degeneration.~   "
84352|NCT02462915|"~     In our study, we compared the ventilation performance of i-gel to the endotracheal tube~     during laparoscopic surgery.~      The lungs were ventilated at tidal volumes (8mL/kg) using volume controlled. After that, we~     wanted to observe the respiratory parameters, such as leak fraction, leak volume, tidal~     volume, peak airway pressure and mean airway pressure.~      In our hypothesis, the i-gel may be used reasonable alternative to tracheal tube during~     volume controlled ventilation in laparoscopic surgeries.~   "
84353|NCT02462902|"~     300 consecutive patients with cirrhosis of any aetiology admitted with features of sepsis and~     sepsis induced hypotension to the intensive care unit, the emergency department and the step~     down units of Institute of Liver and Biliary Sciences, New Delhi, who fulfil the inclusion~     criteria.~      This study will be a single centre prospective randomized comparative trial. Patients will be~     randomized into two groups. Group A will receive crystalloid, 0.9% sodium chloride solution~     (total of 30ml/kg over 30 minutes) and Group B will receive colloid, 5% albumin (250 ml over~     15 minutes).~   "
84354|NCT02462889|"~     This is a prospective, single-blind, randomized study to evaluate intravitreal aflibercept~     injection (IAI) versus sham as prophylaxis against conversion to neovascular age-related~     macular degeneration (AMD) in high-risk subjects.~   "
84355|NCT02462876|"~     This study will assess the long term safety and performance of the GORE® VIABAHN®~     Endoprosthesis for the treatment of patients with Popliteal Artery Aneurysms.~   "
84356|NCT02462863|"~     The purpose of this research study is to determine if the nutrients arginine and fish oil~     will reverse or improve diabetes and to find out what additional good or bad effects a~     combination of arginine and fish oil may have. Both arginine and fish oil are common~     nutrients taken by normal people on a frequent basis. However, they have not been used in~     combination in the proposed doses to reverse diabetes once it is established. This study has~     been approved by the Food and Drug Administration (FDA investigational new drug [IND] 12191).~   "
84357|NCT02462850|"~     The purpose of CLCT-006, a multi-center open-label study, is to evaluate the safety of CL-108~     (hydrocodone 7.5 mg/APAP 325 mg, promethazine 12.5 mg) for the treatment of moderate to~     severe acute pain (flare) associated with osteoarthritis of the knee or hip under actual~     conditions of use.~   "
84358|NCT02462837|"~     The objective of this pilot study is to assess whether Myrbetriq™ will improve post-operative~     ureteral pain and discomfort, reduce bladder storage symptoms and increase quality of life~     following ureteral stenting.~   "
84359|NCT02462824|"~     The purpose of this study is to determine the effects of a home-based exercise intervention~     on walking ability in people with peripheral artery disease. In 200 patients with peripheral~     artery disease (PAD), the investigators are conducting a randomized controlled trial to~     determine whether a patient-centered home-based exercise program improves walking ability,~     physical activity, mobility, pain, and social functioning, compared to a usual care group.~   "
84360|NCT02462811|"~     The objectives of this study are to compare the occurrence and severity of opioid-induced~     nausea and vomiting (OINV) associated with CL-108 to Norco®, and to demonstrate the efficacy~     of CL-108 when compared to placebo for the relief of moderate to severe pain In patients with~     moderate to severe pain following bunionectomy (osteotomy with fixation of the head of the~     first metatarsal bone).~   "
84362|NCT02462785|"~     Helping individuals with diabetes to control their blood sugars through self-management is an~     important goal, and counting carbohydrates (CHO) remains a key part of diabetes education and~     management. There is very little research examining CHO counting education with adolescents~     who have type 1 diabetes (T1DM). The purpose of this pilot study is to evaluate a newly~     developed internet-based teaching module of CHO counting for adolescents, ages 12-17 years,~     with T1DM and who do not regularly CHO count and require instruction. A secondary aim is to~     assess feasibility for a future, larger-scale clinical trail. An effective web-based CHO~     counting tutorial could be used to strengthen current diabetes education programs and may~     serve as a basis for developing other teaching modules. Advantages of web-based teaching~     include convenience, increased accessibility, and the ability to review and reinforce~     teaching concepts through repetition. It may also encourage adolescents to take the~     initiative for their own diabetes care, beginning with a self-directed, active learning~     experience.~   "
84363|NCT02462772|"~     The CAPRISA 014 trial aims to assess the safety and acceptability of the long-acting (LA)~     injectable antiretroviral agent, cabotegravir LA (GSK1265744), in HIV uninfected women in~     KwaZulu-Natal, South Africa.~   "
84364|NCT02462759|"~     The primary objective of Part 1 of this study is to assess the safety and tolerability of~     Nusinersen in participants with SMA who are not eligible to participate in the clinical~     studies ISIS 396443-CS3B (NCT02193074) or ISIS 396443-CS4 (NCT02292537). The secondary~     objective of Part 1 of this study is to examine the pharmacokinetics (PK) of Nusinersen in~     participants with SMA. The primary objective of Part 2 of this study is to assess the~     long-term safety and tolerability of Nusinersen in participants with SMA who participated in~     Part 1 and completed their End of Part 1 Evaluation assessments. The secondary objective of~     Part 2 of this study is to examine the PK of Nusinersen in participants with SMA who~     participated in Part 1 and completed their End of Part 1 Evaluation assessments.~   "
84365|NCT02462746|"~     The purpose of this project is to study the effect of dietary supplementation with a natural~     health product (NHP) with a focus on its effects on its levels in breast milk.~   "
84366|NCT02462733|"~     Self-control has become a strong predictor of academic success and life outcomes. Early~     childhood development research indicates that greater self-control can lead to better health,~     greater wealth, and less propensity to engage in criminal activity. This study seeks to~     assess the strength of the play-based Tools of the Mind (TOM) program in improving~     preschoolers self-control. It will compare TOM to an alternative play-based program, called~     Playing to Learn (PTL), implemented in most YMCA Canada childcare settings across the~     country. This study hypothesizes that measures of self-control and other measures of social~     behavior and academic success in preschoolers after two years in the TOM program will be~     greater than measures of self-control and other measures of social behavior and academic~     success in preschoolers in the PTL program after two-years.~   "
84367|NCT02462720|"~     The purpose of this study is to evaluate pain the patient experienced following treatment of~     varicose veins with Varithena® compared to radiofrequency ablation.~   "
84368|NCT02462707|"~     The purpose of this study is to determine the recommended Phase 2 dose for PF-03084014~     single-agent administration in Japanese patients with advanced solid tumors. Pharmacokinetics~     and the overall safety profile of PF-03084014 will also be evaluated.~   "
84369|NCT02462694|"~     Suicide is a pressing problem in the US military, with evidence of increased risk for suicide~     particularly among soldiers serving in Iraq and Afghanistan. To date, there are very few~     studies that empirically evaluate treatment efficacy to prevent suicide. One treatment that~     has been shown empirically to decrease suicidal behavior is Dialectical Behavioral Therapy~     (DBT), although these studies have been limited to patients with borderline personality~     disorder (BPD). The current proposal aims to examine the efficacy of DBT in reducing suicidal~     behavior more broadly in a diagnostically heterogeneous group of veterans with high risk~     suicidal behavior. One of the difficulties in doing research in suicide prevention is that~     serious suicidal behavior is a relatively rare event, and alone is not a satisfactory target~     for treatment studies. It is extremely important, therefore, to identify intermediate~     symptoms that are closely associated with high risk suicidal behaviors, as targets for~     treatment. One critical area our proposal addresses is validating new treatment models for~     suicide in veterans; DBT has been empirically validated to reduce suicidal behavior in~     individuals with BPD, but has not been tested more broadly to target suicidal behaviors. The~     second critical area which our proposal addresses is exploring new suicide risk assessment~     measures. While the investigators do not specifically propose to develop new screening tools,~     the investigators do propose to identify potentially important domains that specifically~     differentiate ill high risk suicide veterans from low risk. This information will be useful~     in future efforts to modify the DBT approach to be more effective for the broader diagnostic~     group of high risk suicidal veterans.~   "
84370|NCT02462681|"~     This study aims to investigate the safety and the analgesic efficacy of adding Ketamine to~     bupivacaine 0.25% in thoracic PVB in patients undergoing modified radical mastectomy.~   "
84371|NCT02462668|"~     This study is to investigate the efficiency and safety of fibreoptic bronchoscopy assisted~     intubation during noninvasive positive pressure ventilation in respiratory failure patients.~     Half of the participants will receive preoxygenation with noninvasive ventilator and~     fibreoptic bronchoscopy intubation during NIPPV. While the other half using usual~     preoxygenation(bag-mask ventilation ).~   "
84382|NCT02462525|"~     This is a Phase 1/1b, open-label, dose-escalation study designed to evaluate the safety,~     pharmacokinetics, and to determine the recommended Phase 2 dose of ABBV-838 in subjects with~     relapsed and refractory multiple myeloma.~   "
84383|NCT02462512|"~     For patients with thyroid gland nodule, fine-needle aspiration biopsy has been proved to be~     an efficient tool for thyroid cancer diagnosis. However, it is somewhat an invasive procedure~     and is subject to sampling and analysis uncertainties. Thus, improved, more reliable criteria~     for determining which nodule should be be aspirated are needed. Ultrasound elastography has~     been shown to be useful in the differential diagnosis of breast and prostate cancers.~     Ultrasound elastography also may discriminate malignant from benign nodule.~   "
84384|NCT02462499|"~     The aim of the study is to determine the efficacy and safety of treatment with the drug~     eplerenone in patients with chronic central serous chorioretinopathy.~   "
84372|NCT02462655|"~     Familial hypercholesterolemia (FH) is an autosomal codominant single-gene disorder caused by~     mutations in the LDL receptor gene that disrupt the normal clearance of LDL particles from~     the plasma compartment. Heterozygous patients present a 2- to 3-fold raise in plasma~     LDL-cholesterol (C) concentrations, tendinous xanthomatosis and premature atherosclerotic~     coronary heart disease (CHD), usually occurring between the age of 35 and 55 years. Since the~     mid-1970s, LDL-C has been removed from the blood of patients using plasmapheresis, and this~     technique has been shown to improve the life expectancy of FH homozygotes. LDL apheresis~     selectively removes LDL particles but not immunoglobulins and other beneficial proteins,~     thereby overcoming a potential drawback of the traditional plasmapheresis method. LDL-C is~     effectively reduced by more than 60% immediately after LDL apheresis, although LDL levels~     rebound rapidly.~      Dextran sulfate adsorption is a commonly apheresis technique used in familial~     hypercholesterolemia patients. In this apheresis plasma is separated from red blood cells and~     passed over columns of cellulose beads containing dextran sulfate which binds apolipoprotein~     B (apoB) by a highly selective electrostatic binding mechanism. Since LDL, very-low density~     lipoprotein (VLDL), and Lipoprotein (a) all contain apoB, dextran sulfate adsorption~     apheresis selectively reduces these lipoproteins while having little effect on the non-apoB~     containing HDL particles. In clinical practice, LDL apheresis reduces the rate of future~     cardiovascular events and has been postulated to have additional effects on potentially~     pro-atherogenic factors. Some proteins have been identified with adhesive characteristics to~     lipoproteins, rheological, immunological and inflammation relevant proteins16-19 that~     influence microcirculation as well as the inflammatory response. However, no studies have yet~     to investigate the impact of LDL apheresis on the expression of different genes involved in~     cardiovascular disease.~      The main objective of the present research project is to investigate the impact of the LDL~     apheresis dextran sulfate adsorption system on the messenger ribonucleic acid (mRNA)~     expression of genes involved in cardiovascular disease using microarrays analysis in 9 FH~     homozygotes.~   "
84373|NCT02462642|"~     The Indian Ayurvedic herb Brahmi (Bacopa monniera) has been used to improve cognitive~     functions in Indian sub-continent for many years and previous intervention studies have shown~     positive effects of Brahmi on cognitive performance in adults. However, the studies are~     conducted on various fractions and extracts and there is high likelihood of variability of~     composition amongst the fractions/extracts tested in these studies. Furthermore, although the~     findings of the previous studies overlap to some extent, they are not consistent and there is~     a need to replicate these findings.~      Further, even though Brahmi has been studied for its chemical composition and its therapeutic~     benefits as a whole, there are still severe gaps with respect to the complete composition of~     the Brahmi plant or its extracts. No published data exist on the Pharmacokinetics (PK)~     properties of Brahmi components. Hitherto, the evidence and the mechanistic details are still~     speculative and the biological activity is still phenomenological. Because of this severe~     knowledge gap, this study will try to repeat the findings on cognitive performance and at the~     same time also explore the plasma levels of its components in order to initiate the~     understanding of ADME aspects and its linkages to the biological effect.~   "
84374|NCT02462629|"~     Many types of cancer are primarily treated with surgery and patient survival is directly~     related to the extent to which the tumor is able to be removed. It is often difficult for~     surgeons to distinguish tumor tissue from normal tissue or to detect tumor cells that have~     spread from the original tumor site, resulting in incomplete removal of the tumor and reduced~     patient survival. In some sites, such as the brain, it is critical to avoid damage to normal~     tissue around the tumor to prevent adverse effects of surgery on function. The investigators~     hypothesize that BLZ-100 will improve surgical outcomes by allowing surgeons to visualize the~     edges of the tumor and small groups of cancer cells that have spread to other sites in~     real-time as they operate. This is a safety study to assess the safety of BLZ-100 in~     pediatric patients with central nervous system tumors.~   "
84375|NCT02462616|"~     This is a large-scale, community-based, cross-sectional study to evaluate environmental and~     genetic risk factors for cardiovascular autonomic neuropathy in general Chinese population.~   "
84376|NCT02462603|"~     Open-label study with 30-day run-in phase and adaptive design component to include more~     subjects if deemed appropriate by investigators.~   "
84377|NCT02462590|"~     Probiotics are commercially available live bacteria thought to have health benefits when~     ingested. A literature review of probiotic studies in the intensive care unit (ICU) found~     that in patients who receive probiotics, there is a 25% reduction in lung infection, known as~     ventilator-associated pneumonia (VAP). There is also an 18% reduction in the chance of~     developing any infection in the ICU. However, the studies reviewed were small and not well~     done. Therefore, whether probiotics are really helpful or not is unclear. Before a large~     carefully performed study is done to evaluate the effects of probiotics in critically ill~     patients, a pilot trial was needed. The Investigators completed a multicenter pilot RCT for~     which the primary outcomes relate to feasibility. Feasibility goals were met. 1) Recruitment~     for the Pilot was achieved in 1 year; 2) Adherence to the protocol was 96%; 3) There were no~     cases of contamination; 4) The VAP rate was 15%. This study is very important in the ongoing~     search for more effective strategies to prevent serious infection during critical illness.~     Probiotics may be an easy-to-use, readily available, inexpensive approach to help future~     critically ill patients around the world.~   "
84378|NCT02462577|"~     This study investigate the effect of addition morphine to locally instillation bupivacaine on~     developing chronic neuropathic pain acute postoperative pain after breast cancer surgery and~     on the probability of developing chronic neuropathic pain.~   "
84379|NCT02462564|"~     Objectives to investigate the incidence and associated factors for early postoperative~     cognitive dysfunction in the patients with peritoneal surface malignancies undergoing~     cytoreductive surgery and hyperthermic intraperitoneal chemo-therapy(CRS-HIPEC).Methods fifty~     patients aged 18-65 yr were included in the research and were grouped base on the score of~     neuropsychological assessments which had done in the ward at 7 day before and after the~     surgery. The investigators monitored various indicators in the perioperative period, such as~     age, body weight, sex, education, duration of operation, intraoperative blood loss,~     cardiovascular events, amount of fluid infused per hour. Meanwhile, the concentration of~     serum amploid A (SAA),IL-1beta,TNF-alpha,HMGB1,S100b,cortisol and Abeta40 were measured at~     the various stage of the operation and 24 hours after the operation, and the differences of~     data between postoperative cognitive dysfunction(POCD) and Non-POCD groups were analyzed.~   "
84380|NCT02462551|"~     The purpose of this study is to determine the efficacy and any possible side effects of focal~     electrically administered seizure therapy (FEAST) as a treatment intervention for patients~     with recurrent and treatment resistant depression.~   "
84381|NCT02462538|"~     This is an open label pilot study of combining BV in a licensed indication with imatinib in~     patients with ALCL. It is intended as a window of opportunity trial in which the study~     drugs will be given as an initial substitute for conventional chemotherapy with the intention~     to achieve a remission enabling the patients to proceed to autologous or allogeneic stem cell~     transplantation, if eligible.~   "
84387|NCT02462460|"~     The purpose of this study is to create a rapid scan of the pancreas and ovaries that could be~     used in the future to screen patients at risk for pancreatic or ovarian cancers. Currently,~     Magnetic Resonance Imaging (MRI) examinations of the pancreas and ovaries can last 30-45~     minutes each. The investigators hope to create a rapid pancreatic and ovarian MRI evaluation~     that can be used as a screening tool that is completed in approximately 15 minutes. They will~     compare different tools available on modern MRI scanners to see which one reliably offers~     high quality images of the pancreas and ovaries.~   "
84388|NCT02462447|"~     Men with and without prostate cancer will have a PET/CT scan that measures the level of the~     amino acid sarcosine. PET is a scanning method that uses short lived radioactivity.~   "
84389|NCT02462434|"~     This study evaluates maternal psychological distress and the impact of early palliative care~     team consultation on maternal anxiety and depression symptoms, coping, and quality of~     life/family functioning in the care of neonates born with single ventricle physiology. Half~     of the participants will receive early palliative care team consultation, while the other~     half will receive usual care (no or late palliative care intervention). The investigators~     hypothesize maternal stress, anxiety, and depression will be lower in the palliative care~     intervention group compared with the control group, and maternal coping mechanisms and~     perceived quality of life and family functioning will improve at the pre-discharge~     assessment.~   "
84390|NCT02462421|"~     Sodium-dependent glucose transporter-2 (SGLT2) inhibitors are a new class of anti-diabetic~     drugs, which increase urinary glucose excretion thereby promoting weight loss and decreasing~     plasma glucose levels. We hypothesize that the pharmacodynamic response to SGLT2 inhibitors~     (specifically canagliflozin) varies among individuals, and that a proportion of this~     inter-individual variation can be explained by genetic variation. This is a pilot study in~     healthy, non-diabetic subjects in whom glucose and other related metabolites in the urine and~     plasma will be measured before and after administration of a single dose of canagliflozin.~     This will allow us to characterize the inter-individual variation in the pharmacodynamic~     response to canagliflozin as well as determine if changes in glucose and other related~     metabolite levels are associated with variants in various candidate genes.~   "
84391|NCT02462408|"~     The lateral parasagittal in-plane is the current conventional approach in ultrasound-guided~     infraclavicular brachial plexus block. However this technique is less popular because~     brachial plexus at the infraclavicular level runs deeper compared to its course proximally,~     often give rise to impaired needle visualisation due to its steep angle of needle trajectory~     to the ultrasound beam. A new posterior parasagittal in-plane approach was introduced to~     improve needle visibility. This approach proved feasible from our case series hence the~     investigators would like to compare it with the conventional method in this study~   "
84392|NCT02462395|"~     Cluster headache is a primary headache that chiefly affects young men, and is less common~     than migraine. This disease can have devastating consequences due to the pain intensity (it~     is also called suicide headache), to the side effects of the drug preventive therapies, and~     to the resistance of some subtypes of the headache to all existing medications.~      Recent studies suggest that cluster headache could be associated with a decrease of the~     activity of frontal areas involved in descending pain control, in particular the subgenual~     anterior cingulate cortex. The aim of this pilot study is to activate these areas with a~     non-invasive neurostimulation technique, called transcranial direct current stimulation, as a~     preventive treatment for cluster headache sufferers.~   "
84393|NCT02462382|"~     Arthroscopic rotator cuff repair is a common and painful procedure routinely performed on an~     outpatient basis. Postoperative pain control regimens can include narcotic pain medicine,~     non-steroidal anti-inflammatory medications and regional anesthesia such as an interscalene~     block (ISB). Regional blocks such as ISB can safely provide complete pain relief for the~     shoulder and upper extremity for eight to twelve hours1. However, the shoulder is still very~     painful when the block wears off. The purpose of this study is to:~        1. Examine the efficacy of continuous infusion scalene block ropivacaine catheters during~          the first two days after arthroscopic rotator cuff repair.~        2. Examine narcotic consumption after continuous infusion scalene block ropivacaine and~          placebo catheters after arthroscopic rotator cuff repair.~        3. Evaluate for any continued pain relief benefit of continuous infusion scalene block~          ropivacaine catheters during the three days after the infusion catheters have finished.~   "
84394|NCT02462369|"~     This study compare the effects on microalbuminuria improvement in type 2 diabetes mellitus~     (T2DM) treated with saxagliptin or glimepiride.All patients received metformin and/or~     acarbose, and randomly receive saxagliptin (5mg/d) or glimepiride (1-4mg/d).~   "
84395|NCT02462356|"~     This study evaluate multiple-portal VATS and uniportal VATS lobectomy for NSCLC, half of~     participants will receive multiple VATS, while the other half will receive uniportal VATS~     lobectomy.~   "
84396|NCT02462343|"~     All measurements are performed on two consecutive days at the beginning of a pulmonary~     rehabilitation program in a randomized cross-over study design. On the first day, each~     patient is randomly assigned to perform either the 2 minute walk test or the 6 Minute walk~     test. On the second day each patient performs the test that was not performed on the first~     day. All walk tests are performed by the same investigator on the same track and time of day,~     following the 2002 guidelines of the American Thoracic Society.~      Patients wear a mobile pulse oximeter that continuously records heart rate and oxygen~     saturation during testing. Baseline values of oxygen saturation, heart rate and ratings of~     perceived exertion on the modified Borg scale (0 to 10) for dyspnea and leg fatigue are~     recorded at rest after 10 minutes of sitting.~   "
84397|NCT02462330|"~     Stem cell therapy is an emerging treatment for cardiovascular disease but the best cell type~     and delivery method remain to be determined. Pre-clinical studies demonstrated improvement of~     cardiac function by Mesenchymal stem cells (MSC) therapy in particular by their paracrine and~     immunosuppressive properties. Investigators initiated the MESAMI program by the bicentric~     pilot phase and highlighted the safety and feasibility of intramyocardial injections of MSCs~     from bone marrow in patients with chronic ischemic cardiomyopathy and left ventricular~     dysfunction, guide by the NOGA-XP system. The MESAMI program continues with the phase 2,~     multicenter, double-blind, randomized, placebo-controlled trial.The aim of this phase 2 study~     is to demonstrate a functional improvement, measuring peak VO2, at 3 months between the cell~     therapy group and the placebo group.~   "
84398|NCT02462317|"~     Stroke is the first cause of motor impairment and disability in adults. Then the main~     objective of rehabilitation during the first six months following stroke is to facilitate~     motor recovery. Many post-stroke hemiplegics develop spasticity which is responsible for an~     increase of disability. Then antispastic drugs are frequently prescribed to the patients even~     during the post-stroke recovery phase. Until recently most of french patients were treated by~     oral tablets of baclofen. Now the number of patients receiving intramuscular injections of~     botulinum A toxin is increasing. However in the literature, these drugs have been tested in~     post-stroke spasticity during the chronicle phase, after the sixth month and their action on~     motor recovery remain largely unknown. Then it is necessary to evaluate more accurately the~     effects of its drugs on motor recovery. The main criterion of its study is the time course of~     Fugl-Meyer Motor Assessment (FMA). Spastic patients with a single stroke, since less than two~     months, will be included in the try. They receive at the same time oral tablets for five~     months and intramuscular injections. Patients are randomized in three arms planned with a~     distribution balanced by group of 5 patients with a 2 -2- 1 model: botulinum toxin and~     placebo baclofen (120 patients), oral baclofen and placebo botulinum toxin (120 patients),~     placebo baclofen and placebo botulinum toxin (60 patients). The FMA score will be assessed~     before treatment start, one month and three months later. Spasticity, functional abilities,~     capacity in the activities of daily life, pain and quality of life will be also assessed~     during the study with Tardieu score, Rivermead Motor Assessment scale, Barthel index, Rankin~     score, Visual Analogic Scale and Reintegration to Normal Life Index respectively. A positive~     difference of 12 points in the time course of FMA in the botulinum toxin group in comparison~     with the baclofen group will be considered as the minimum relevant effect. 300 patients have~     been planned to be included in 20 centers during the 2 years of trial.~   "
84399|NCT02462304|"~     Objectives:~      To compare the efficacy of monotherapy with anti-Vascular Endothelial Growth Factor~     (ranibizumab or bevacizumab) with combined therapy with anti-Vascular Endothelial Growth~     Factor and end-point-management grid laser photocoagulation for diabetic macular edema.~      Study design:~      Open-label non-randomized interventional study.~      Study overview:~      This study aims to look at the efficacy of treating diabetic macular edema (DME) with either~     anti-Vascular Endothelial Growth Factor(anti-VEGF) monotherapy, compared with combination~     therapy with anti-VEGF and End-Point-Management (EPM) grid laser photocoagulation, over a~     period of 6 months.~      Various sites from across Asia (Japan, South Korea, Hong Kong) will participate. Depending on~     the availability of EPM laser, sites can either contribute to the 'Anti-VEGF monotherapy'~     arm, or to the 'Combination therapy' arm.~   "
84400|NCT02462291|"~     Alzheimer's disease (AD) is the most frequent form of dementia, causing high level of~     disability with elevated social costs. Alternative solutions to the standard pharmacological~     therapies have been studied in order to reduce the use of medications that frequently~     generates side effects and worsen patients' quality of life. A recent alternative treatment~     for AD is the Environmental Ecological Therapy (EET) that, with the use of therapeutic~     gardens, seems to reduce behavioral disorders (BD). However, the effectiveness of this~     approach is still mater of debate. Therefore, the aim of this trial will be to analyze the~     effects of EET, in people with severe AD.~   "
84401|NCT02462278|"~     This study evaluates the safety and usability of a continuous temperature sensor for women.~     Data will compare the date of ovulation identified by the continuous temperature sensor to~     that of transvaginal ultrasound and serum progesterone levels. Subjects will also compare~     sensor results to once-daily oral temperatures and urine luteinizing hormone (LH) status.~   "
84402|NCT02462265|"~     The study will be a prospective open-label single-center study in previously treated patients~     with Acute Myeloid Leukemia (AML) or Acute Lymphoid Leukemia (ALL). Treatment efficacy and~     safety of the combination of Oshadi D (DNase in Oshadi carrier) and Oshadi R (RNase in Oshadi~     carrier) with Salvage Chemotherapy will be evaluated. Oshadi D and Oshadi R were shown to~     have anti-tumor activity and good safety profile.~      Patients will receive Oshadi D and Oshadi R oral treatment combined with salvage~     chemotherapy. Patient will be evaluated throughout the study for safety and tolerance to~     multiple dose regimens of Oshadi D and Oshadi R.~      Efficacy will be determined by percentage of bone marrow blasts assessment at day 28 post~     therapy initiation.~   "
84403|NCT02462252|"~     An open label single arm study to assess efficacy and safety of BL-8040 on top of standard~     immunotherapy regimen of hATG, cyclosporine and steroids in patients with Hypoplastic MDS and~     AA over the course of a six month (180 day) treatment period.~   "
84404|NCT02462239|"~     Bladder cancer is the fifth most common cancer in Canada and there has been relatively little~     progress in altering its clinical course over the last three decades. One of the major~     problems identified in the management of this disease, is under staging of muscle invasive~     disease which can lead to suboptimal treatment and outcomes. PET-CT has the potential to more~     accurately stage MIBC than standard CT by detecting pelvic adenopathy and/or distant sites of~     disease that may not be found on standard imaging. In the former situation, more aggressive~     therapy with extended lymph node dissection and/or neoadjuvant chemotherapy prior to~     cystectomy can be offered. While in the latter situation patients can be spared the morbidity~     of a cystectomy performed in a setting of metastatic disease. This study will address whether~     PET-CT adds a clinically meaningful difference in care.~   "
84405|NCT02462226|"~     The purpose of this research study is to conduct a randomized clinical trial to evaluate the~     efficacy of the web-based The-Optimal-Lymph-Flow ™ system for managing chronic pain and~     symptoms related to lymphedema focusing on primary outcomes of pain reduction, secondary~     outcomes of symptom relief, limb volume difference by infra-red perometer, body mass index,~     quality of life related to pain.~      Recruitment includes 120 patients who will be randomized according to pain/aching/soreness,~     and tenderness. Participants in the intervention group will be provided the web-based~     The-Optimal-Lymph-Flow ™ intervention and encourage to access and learn about the program~     during the 1-4 weeks of the study. Participants in the control group will receive the~     web-based arm precaution program. All the participants will have monthly online assessment of~     pain and symptoms at 4 and 8 weeks post-intervention as well as two in-person research~     visits, that is, prior to intervention and 12 weeks post-intervention.~   "
84406|NCT02462213|"~     Cardiac amyloidosis describes a process by which abnormally folded proteins infiltrate the~     heart tissue. Given the insidious nature of this disease process, diagnosis is often too late~     for a meaningful intervention. Advances in the treatment of the amyloidoses have improved~     outcomes for patients with these conditions. The focus of this study is to identify the~     involvement of the heart, most closely associated with mortality, so that aggressive~     management can be instituted improving prognosis.~   "
84443|NCT02461732|"~     The purpose of the study is to determine whether a novel integrated cognitive-behavioral~     treatment for posttraumatic stress disorder (PTSD) and substance dependence (i.e., Treatment~     for Integrated Posttraumatic Stress and Substance use; TIPSS) is more effective than~     cognitive-behavioral treatment for substance dependence alone with regard to PTSD symptoms~     and substance use quantity and frequency.~   "
84407|NCT02462200|"~     The investigators propose a randomized controlled superiority trial of standard~     breast-conserving surgery (BCS) versus BCS with cavity shave margins (CSM). The main~     objectives of this trial will be to evaluate prospectively the impact of routine standardized~     CSM on margin status following primary surgery for early stage breast cancer (Stage 0 - II),~     on post-operative patient satisfaction and cosmetic outcomes, and on general intraoperative~     time and operative costs. A parallel group format will be implemented to compare this~     modified surgical therapy - BCS with CSM - with BCS alone, which is the current standard of~     care.~   "
84408|NCT02462187|"~     This is a randomized, double-blind, vehicle-controlled, ascending dose study to assess~     safety, tolerability and efficacy of a topical nitric oxide releasing compound in subjects~     with external genital and perianal warts. Eligible subjects will be treated with a topical~     gel (active or vehicle) for up to 12 weeks.~   "
84409|NCT02462174|"~     To find alternatives to caudal analgesia that could be more safe and effective and to~     demonstrate the analgesic efficacy of topical ketamine.~   "
84410|NCT02462161|"~     This pilot clinical trial will examine the effects of intranasal insulin aspart on cognition,~     daily function, blood and cerebral spinal fluid markers of Alzheimer's disease, and amyloid~     deposition in the brain. Participants will be randomly assigned to receive insulin aspart or~     placebo during a 12-week treatment period.~   "
84411|NCT02462148|"~     This study will look at the efficacy of dexamethasone for prolongation of peripheral nerve~     blocks.~   "
84412|NCT02462135|"~     This study sought to investigate the changes in objective memory performance (including~     immediate recall and delayed recall), subjective memory complaints and degree of depression~     in older adults with mild cognitive impairment after Virtual interactive memory training~     (VIMT).~   "
84413|NCT02462122|"~     Safety and Efficacy of IDP-118 in the treatment of plaque psoriasis~   "
84414|NCT02462109|"~     Nodding Syndrome is an enigmatic neuropsychiatric syndrome affecting children and adolescents~     mostly in Eastern Africa. The symptoms of Nodding Syndrome and catatonia seem to overlap. The~     researchers' objectives in this study were to investigate the presence and types of catatonic~     symptoms in children with Nodding Syndrome and observe their response to one or two doses of~     lorazepam, the first-line treatment for catatonia.~   "
84415|NCT02462096|"~     This study is designed to evaluate the safety and technical feasibility of the ReLeaf~     Catheter System in the creation of one or more tissue leaflets in the femoral and/or~     popliteal vein in subjects with chronic venous insufficiency and who meet the protocol entry~     criteria.~   "
84416|NCT02462083|"~     The objective of this study is to evaluate the long-term safety of IDP-118 Lotion.~   "
84417|NCT02462070|"~     The objective of the study is to evaluate the safety and efficacy of a topical lotion.~   "
84418|NCT02462057|"~     The Vitality HealthyFood benefit is a three-tiered incentive program designed to encourage~     healthier food choices amongst members of Discovery Health's Vitality program. Once enrolled~     in the benefit, participating members can receive 10%, 15%, or 25% cash-back on the healthy~     foods they purchase at selected grocers. And, while overall enrollment in the program is~     high, there is particular interest in increasing enrollment in the benefit amongst Vitality~     members with diabetes. One presumed barrier to enrollment in the benefit amongst members with~     diabetes is a misperception of the particular relevance of the benefit and healthier food~     choices for their personal health. Improved messaging regarding the HealthyFood benefit and~     its particular salience for individuals with diabetes may be an effective means of increasing~     activation of the benefit in this population. The proposed study will be a collaboration~     between Discovery Health/Vitality and researchers at the Perelman School of Medicine at the~     University of Pennsylvania. In the proposed RCT, Vitality members with diabetes will be~     randomised to different types of messages regarding the HealthyFood benefit. The~     investigators will then compare the effectiveness of these different messaging strategies at~     increasing activation of the HealthyFood benefit amongst Vitality members with diabetes.~   "
84419|NCT02462044|"~     Computed tomographic angiography (CTA) is an important prognostic tool with regard to the~     detection of coronary artery stenoses. Both iodine delivery rate (IDR; the amount of iodine~     delivered to the patient per second) and iodine concentration are decisive factors in the~     opacification of arterial vessels.~      There remains to be some debate in the literature about whether the use of high iodine~     concentration contrast media is beneficial compared to lower iodine concentrations.~      To date, there have not been any studies comparing intracoronary attenuation using~     concentrated contrast media lower than 300 mg I/ml at coronary CTA. For a reliable comparison~     of CM with different iodine concentrations, adapted injection protocols insuring an identical~     IDR (in g iodine per second) are mandatory. The investigators hypothesize that usage of lower~     iodine concentrations, while maintaining identical IDR and total iodine load, will result in~     comparable diagnostical intra-vascular attenuation in CTA.~   "
84420|NCT02462031|"~     To Evaluate the safety, tolerability and pharmacokinetic property after KD101 multiple oral~     dosing in the fed state in obese or overweight subjects.~   "
84434|NCT02461849|"~     KIT is a receptor tyrosine kinase that binds to stem-cell factor (SCF), activating a series~     of downstream effector pathways. KIT is an established therapeutic target in cancer with~     activating mutations of KIT, such as gastrointestinal stromal tumors (GIST), and significant~     benefit is achieved with various small molecule inhibitors of KIT such as imatinib mesylate.~     Moreover, there is increasing evidence implicating KIT mutations as tractable therapeutic~     targets in melanoma. Additional information is required to characterize the functional role~     of low-frequency mutations in KIT and to determine whether amplification of wild type KIT is~     a real driver that can be targeted therapeutically. Except GIST and melanoma, other solid~     cancers were reported to have KIT mutation even in low frequency. A molecular profiling of~     the tumors of patients referred to the phase I clinic at the M.D. Anderson Cancer Center~     showed KIT mutation in 7 patients in total of 431 patients (2%).~      Hence, the investigators planned this study to apply the molecularly targeted agent, imatinib~     to various types of cancers harboring KIT mutation or amplification.~   "
84444|NCT02461719|"~     The purpose of this clinical Study is TJCS Eye Drops 0.05%(Cyclosporine ophthalmic~     nano-emulsion) group and Restasis Eye Drops 0.05%(Cyclosporine ophthalmic suspension) group~     12 weeks after treatment, each treatment group comparisons for evaluation of efficacy and~     safety in Moderate to Severe Dry Eye Disease.~   "
84421|NCT02462018|"~     Cerebral palsy (CP) is the most common neuromuscular disorder among children, resulting from~     a non-progressive injury during early brain development which leads to impairment of movement~     and posture.~      Muscle weakness and spasticity associated with CP limit the joint range of motion and~     negatively impact ambulatory ability. Most ambulatory children with CP are prescribed with~     ankle-foot orthoses (AFOs) to improve ankle position and stability and to maintain muscle~     range. Nevertheless, AFOs may also restrict desired motions and may exacerbate muscle~     weakness and atrophy.~      During the last years a novel method is being used for treating upper motor neuron drop foot,~     by means of dynamic orthoses, namely Functional Electrical Stimulation (FES).~      These FES devices cause dorsiflexion of foot by stimulating the peroneal nerve and activating~     the tibialis anterior muscle. Most of the studies of FES devices were conducted on adult~     population. These studies showed improvement in laboratory and functional gait parameters.~     There are relatively few studies on children with hemiplegic or diplegic CP with favorable~     results. There is no solid evidence whether the improvements seen in laboratory setting of~     children with CP, are reflected on functional ambulation in daily life. In addition, there~     are no defined parameters which could predict the response to FES among those children.~      The aim of this study is to determine whether using FES device (WalkAide; Innovative~     Neurotronics, Austin, TX, USA) improves daily motor function and gait parameters in children~     with spastic hemiplegic or diplegic CP. additionally, we aim to define clinical and~     biomechanical parameters that can predict a favorable response to using the FES device.~   "
84422|NCT02462005|"~     A total of up to 250 patients from an all-comers patient population with infrainguinal~     atherosclerotic disease who are implanted or scheduled for an implant with a Ranger Drug~     coated balloon.~      Interim analysis will be carried out for every 50 subjects enrolled.~   "
84423|NCT02461992|"~     An open-label, single dose pharmacokinetic study of Xyntha (Moroctocog Alfa (AF-CC),~     Recombinant Factor VIII) in male Chinese subjects with hemophilia A~   "
84424|NCT02461979|"~     Previous data have suggested that vitamin D levels may influence cancer development. In~     particular, several single nucleotide polymorphisms have been described in the Vitamin D~     receptor( VDR gene), and some polymorphisms are associated with tumor occurrence. For~     instance, VDR polymorphisms have been related to cancers of the breast, prostate, skin,~     colon-rectum, bladder and kidney, although with conflicting observations . VDR polymorphisms~     have also been investigated in the context of some chronic liver diseases, such as chronic~     hepatitis B, primary biliary cirrhosis and autoimmune hepatitis . In a recent published~     study, VDR polymorphism may be used as a molecular marker to predict the risk and to evaluate~     the disease severity of HCC in patients with chronic hepatitis B.~      A significant association of VDR (ApaI) polymorphism with the development of HCC in chronic~     HCV infection may help to identify those who are at high risk of developing HCC.~   "
84425|NCT02461966|"~     Hepatocellular carcinoma is multifactorial in etiology and complex in pathogenesis, the blend~     of risk factors differs in different parts of the world, and this may explain in part the~     diverse biologic characteristics of HCC in different populations .~      Exposure to aflatoxin is an additional risk factor for the development of HCC, through damage~     of DNA in liver cells and mutation in p53 tumor suppressor gene . A previous study showed~     that aflatoxin B1 has a considerable role in the development of HCC among Egyptians .~      Clinical studies have shown that AFB1 selectively targets at the third base position of codon~     249 of the human p53 gene, a known mutational hotspot in human hepatocellular carcinoma (HCC)~     . A significant association between aflatoxin exposure and HCC has been reported in~     hyperendemic areas . A synergistic interaction between AFB1 exposure and viral hepatitis B~     (HBV) infection on HCC risk has been reported in several epidemiologic studies.~      Aflatoxin exposure may be associated with advanced liver disease in chronic hepatitis C (HCV)~     patients. Levels of AFB1-albumin/albumin were significantly related to ultrasono-graphic~     hepatic parenchyma scores in anti-HCV-positive subjects .~   "
84426|NCT02461953|"~     This study is a prospective, randomized, controlled multicenter clinical study. The aim of~     the study is to investigate whether the combination of maintenance hemodialysis (MHD) with~     hemoperfusion (HP) could improve the clearance rate of middle and large molecule uremic~     toxins so as to improve the quality of life of MHD patients and reduce their mortality rate.~   "
84427|NCT02461940|"~     A randomized controlled trial conducted on 688 sexually experienced adolescents, with 337~     participants assigned to the routine program, and 351 to the new intervention developed from~     an assessment of their needs. All participants will complete a self-administered~     questionnaire and an interview on their knowledge of sexually transmitted infections~     (STIs)/Human Immunodeficiency Virus (HIV), self-efficacy, skills in negotiating for sexual~     abstinence or condom use, and sexual behaviors at baseline and at 6- and 12-months' post-~     intervention. All will be tested for STIs. Participants in the intervention group will~     receive 4 individual counseling sessions on STIs/HIV knowledge, life skills, secondary~     abstinence, safer sex and healthy relationships over 1 year. They will also be referred to~     counselors for proactive social and emotional support delivered through electronic media and~     other means. The control group will receive the usual counseling session at first and~     follow-up clinic visit.~   "
84428|NCT02461927|"~     The investigators will compare 3 treatment groups (ketamine plus naltrexone vs. ketamine~     alone vs. placebo) for treating major depressive disorder (MDD) and alcohol use disorder~     (AUD) in an 8-week randomized, double-blind, placebo-controlled, between-subjects trial.~     First, prior to the double-blind trial, the investigators will conduct an open-label trial~     that will include 5 patients with comorbid MDD and AUD to test safety and efficacy of~     repeated ketamine treatment (0.5 mg/kg; once a week for 4 weeks; a total of 4 ketamine~     infusions) with a follow-up of 4 weeks. Second, after reviewing the safety and efficacy of~     repeated ketamine treatment from the open-label trial, the investigators will conduct an~     8-week, randomized, double-blind, placebo-controlled trial that will include 60 patients with~     comorbid MDD and AUD to test safety and efficacy of repeated ketamine treatment (0.5 mg/kg;~     once a week for 4 weeks; a total of 4 ketamine infusions) plus naltrexone with a follow-up of~     4 weeks. The 4-month follow-up session will also occur.~   "
84429|NCT02461914|"~     To assess the effect of PEX168 doses on the pharmacokinetics of warfarin in healthy~     subjects.To provide a scientific basis for clinical drug combination of PEX168.~      To evaluated the impact of pharmacodynamics coadministrated hypodermic PEX168 and warfarin in~     healthy subjects.~      To assess the safety of single doses of warfarin administered with and without PEX168~   "
84435|NCT02461836|"~     Pancreatic cancer is one of the deadliest tumor types of the alimentary system. Resection is~     the only curable method to treat pancreatic cancer. However, even if radical resection is~     achieved, the 5-year survival rate is still low because of tumor recurrence. It's reported~     adjuvant radiation can prolong survival and improve quality of life after surgery. For R0~     (microscopic negative margin) resection patients with advanced stages (T3 or N1), the value~     of adjuvant radiation is still in debate. It's warranted to explore the role of adjuvant~     radiation for patients after radical resection of pancreatic cancer with advanced stages (T3~     or N1) in large, prospective, and randomized cohorts.~      The application of Stereotactic Body Radiation Therapy (SBRT) makes radiation less harmful~     and more flexible. It is hoped that adjuvant SBRT may benefit post-operative patients with~     advanced stages and one day adjuvant SBRT combined with chemotherapy become the standard of~     care for pancreatic cancer patients.~   "
84436|NCT02461823|"~     Investigate the influence of the crown tye Porcelain fused to metal or Zirconia on~     periodontal health.~   "
84437|NCT02461810|"~     The purpose of this study is to compare the safety and effectiveness of the SpineJack® with~     the Kyphx Xpander® Inflatable Bone Tamp and support a non-inferiority finding for the use of~     SpineJack® VCF treatment system versus Balloon Kyphoplasty.~   "
84438|NCT02461797|"~     Recently, a critical role in the development of allergic rhinitis (AR) has been attributed to~     the nasal epithelium. The airway epithelium forms a physical barrier, protecting the nasal~     mucosa and underlying organs from damage from contact with exogenous particles. The nasal~     epithelial barrier is primarily determined by the integrity of the airway epithelium, in~     which epithelial cells are connected to each other by complex network structures like tight~     junctions (TJs), ultimately sealing off the paracellular space. TJs consist of different~     transmembrane proteins including occludin, tricellulin, the claudin family, and junctional~     adhesion molecules. TJ form intercellular homodimers/heterodimers between neighboring cells.~     Scaffold adaptor proteins like cingulin and the zonula occludens family connect the~     transmembrane proteins to the actin cytoskeleton.~      Disturbed TJ function can facilitate the entrance of foreign pathogens and antigens into the~     submucosal layer, giving raise to allergic sensitization via increased access of allergens to~     the dendritic cells and/or inducing persistent inflammation via activation of mast cells and~     other inflammatory cells residing in the upper airways. Chronic disorders like allergic~     asthma, inflammatory bowel disease and atopic dermatitis have been linked to defective or~     altered TJ function. Recently, an impaired epithelial barrier function was found in patients~     with chronic rhinosinusitis with nasal polyps (CRSwNP), suggesting changes in TJ arrangement~     in the nasal cavity. CRSwNP presents a similar inflammation of the sinonasal cavities as~     found in AR patients, i.e. a Th2 cytokine driven inflammation with tissue eosinophilia.~     Nevertheless, the role of TJs and its regulation has not been investigated in AR.~   "
84439|NCT02461784|"~     Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal~     tract which includes Crohn's disease (CD) and ulcerative colitis (UC) which peak in incidence~     (rate or frequency) during the reproductive years. An increasing number of young people will~     face challenging decisions regarding medical management of this chronic disease during a~     period of time when they are still completing schooling, establishing their career, and/or~     are building a family.~      Treatment options for IBD consist of immunosuppressive therapy, such as immunomodulators~     (azathioprine and methotrexate). Methotrexate (MTX) is a folic acid antagonist (a substance~     that interferes with or inhibits the action of another). It is thought that MTX works by~     decreasing the inflammation in the gastrointestinal tract. MTX has been studied for many~     years and in used as treatment in not only IBD, but also in conditions such as rheumatoid~     arthritis and lupus. However, due to concerns about the safety of MTX, particularly in~     regards to fertility and pregnancy has limited its current use.~      Participants are invited to take part in this research project to determine whether the~     treatment of IBD patients with MTX is associated with an increased risk for infertility.~     Investigators will recruit 75 male IBD patients under MTX treatment for their IBD as well as~     75 healthy male controls for a total of 150 patients at the University of Wisconsin Hospital~     & Clinics.~   "
84440|NCT02461771|"~     The objective of this study is to provide initial safety, tolerability and pharmacokinetics~     information of intravitreal administration of APL-2 in order to support further development~     into larger Phase II studies for treatment of patients with AMD.~   "
84441|NCT02461758|"~     Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal~     tract which includes Crohn's disease (CD) and ulcerative colitis (UC). A recent~     epidemiological investigation estimates that nearly 4 million people worldwide are affected~     and approximately 1.4 million of these cases occur in the United States. IBD can lead to~     debilitating symptoms, hospitalizations, decreased quality of life, frequent procedures~     and/or surgery. Treatment options consist of immunosuppressive therapy, such as systemic~     corticosteroids, immunomodulators (thiopurines and methotrexate) and/or biologics, such as~     tumor necrosis factor alpha (TNF) agents or an integrin inhibitor, vedolizumab. They can~     achieve clinical remission and decrease the risk of complications, but also increase the risk~     for opportunistic infections, including influenza.~      Multiple studies have shown lower influenza vaccine responses in patients with IBD compared~     to healthy individuals; IBD patients treated with TNF agents or combination therapy (TNF~     inhibitors and immunomodulators) are very likely to mount a poor immune response. Influenza~     serum antibody concentration correlates with protection from infection following vaccination.~     Therefore, increasing influenza antibody responses in patients with IBD would appear to be~     critical to improving protection from influenza. A high dose (HD) influenza vaccine~     containing four times more hemagglutinin was licensed based on its ability to induce higher~     antibody concentrations compared to standard dose (SD) in adults 65 years or older.~   "
84442|NCT02461745|"~     This is a Phase IV, open-label, multi-center study to evaluate the real world sustained~     virological response rate, subject adherence, and subject reported outcomes during and after~     treatment of non-cirrhotic genotype 1 chronic hepatitis C subjects aged 18 years and older,~     with VIEKIRA PAK (ombitasvir, paritaprevir/r, dasubuvir), with or without ribavirin.~   "
84577|NCT02459977|"~     Basiliximab has been a routine induction therapeutic agent even for well-matched living~     kidney transplantation(KT) with tacrolimus-based immunosuppression in Korea. As tacrolimus is~     a different drug from cyclosporine, the investigators study the usefulness of~     tacrolimus-based immunosuppression without basiliximab in well matched living KT.~   "
84445|NCT02461706|"~     The main goal of this study is to provide treatment with cannabidiol (CBD) to children with~     drug resistant epilepsy through a Physician Expanded Access Investigation New Drug protocol.~     As the controlled therapeutic use of CBD in children is novel, the primary objective of this~     study is to evaluate the safety and efficacy of CBD when administered as adjunctive therapy~     in children that have exhausted the majority of FDA approved antiepileptic drug treatment~     options.~   "
84446|NCT02461693|"~     The purpose of this project is to examine the effect of expectancy on mood and alertness~     after consumption of caffeine treatment or placebo control pill, given that participants~     know their probability for receiving the caffeine versus placebo pill. Participants will be~     randomly assigned a probability (ranging from 0-100%) of receiving caffeine vs. placebo, and~     this probability will be revealed to them before consumption of the assigned pill and~     subsequent cognitive testing. At the time of consumption, neither study staff administering~     the intervention nor participants will know for certain which pill is given to each~     participant. Pill assignment will depend on pre-determined randomization probabilities, which~     will be provided and assigned by the study statistician. By revealing participants'~     individual probability of receiving the caffeine pill, we will induce positive or negative~     expectancies regarding likelihood for receipt of the caffeine pill. These experimental~     manipulations will: 1) estimate the effect of expectancy on cognitive and affective outcomes,~     and 2) allow for a more direct estimate of the effect of the caffeine pill under real-world~     conditions than would a conventional randomized trial.~   "
84447|NCT02461680|"~     Flexors tendon injuries are frequent and serious with a potential of definitive functional~     aftereffects. In the case of partial injury, the treatment is debated. There are 2 techniques~     of possible repair, the direct suture and the tangential resection. The investigators have~     already demonstrated that this last technique was favorable for injuries going to 50 %. In~     the case of partial section between 50 and 75 %, the investigators think that the technique~     of tangential resection compared with the direct suture would not increase the risks of~     secondary breaks, would authorize even an immediate mobilization and would decrease the~     secondary complications.~      The main objective is to highlight that the tangential resection is not lower than the~     classic technique on the clinical plan The secondary objectives are to highlight the~     non-inferiority of the tangential technique in clinical terms (pains, dexterity,~     complications), radiologics (MRI, ultrasound) and functional (function, go back to leisures~     and professional activities)~   "
84448|NCT02461667|"~     This is a 9 month randomised controlled clinical comparing the clinical efficacy of~     1%metformin and 1%alendronate in chronic periodontitis subjects.~   "
84449|NCT02461654|"~     In this prospective observational trial the effect of the Disc FX microinvasive therapy~     should be examined in (approximately 150) adult patients with low back pain.~   "
84450|NCT02461641|"~     This study was designed to determine the heal rate of diabetic foot ulcers at 4 weeks, and~     complete closure at 8 and 12 weeks of patients treated with either NuShield or Affinity~     compared to standard care alone.~   "
84451|NCT02461628|"~     The overall objective of this study is to evaluate the public health impact of targeted~     antimalarials subsidies through scale-up by determining the community-wide effects of~     targeting an antimalarial subsidy through a partnership between Community Health Volunteers~     (CHVs) and the private retail sector. The primary hypothesis to be tested is that offering a~     fixed-price voucher that reduces the cost for ACT purchase in the retail sector conditional~     on a positive malaria test (targeted subsidy) can improve uptake of testing for malaria and~     will increase the proportion of fevers tested for malaria before treatment. The study will be~     carried out in two sub-counties in Kenya with similar malaria burden but different access to~     health services; the investigators will use a cluster-randomized design to assign community~     units (CUs) in each sub-county to either an intervention or control arm. CHVs will be trained~     to use malaria rapid diagnostic tests (RDTs) to diagnose malaria in household members with~     documented or reported fever; households in intervention CUs will be informed of the~     intervention and encouraged to contact the CHV for any febrile illness in the home. There are~     minimal risks associated with receiving an RDT. Households with a positive RDT will be given~     a serialized voucher that will entitle the holder to purchase a quality assured ACT in the~     retail sector at a reduced, fixed price. The primary and secondary outcome measures will be~     compared at baseline and 12 months post-baseline through population-based surveying.~     Population-based surveying conducted at 6 months and 18 months post-baseline will provide~     additional information. The primary aim is to determine whether there is significant~     difference between the 2 study arms in the proportion of clients with fever who are tested~     prior to any treatment after adjusting for relevant covariates.~   "
84452|NCT02461615|"~     The major goal of this study is to establish a National PAP Registry to help make reliable~     new research tests available to doctors to improve the diagnosis of PAP, increase awareness~     and knowledge of PAP, and give patients a 'seat at the table' in planning and conducting PAP~     research including the clinical testing of several new potential therapies.~   "
84453|NCT02461602|"~     ELITE (Eliminate Thromboembolism: Improving Anticoagulation in Non-valvular Atrial~     Fibrillation Patients) is a two year research project to assess warfarin management issues~     faced by atrial fibrillation (AF) patients in ambulatory settings.~   "
84454|NCT02461589|"~     This trial is conducted globally. The aim of this trial is to investigate dose-finding of~     semaglutide administered subcutaneously once daily versus placebo and liraglutide in subjects~     with type 2 diabetes~   "
84455|NCT02461576|"~     Compare the clinical performance of the Xpert® HIV-1 VL to another FDA approved HIV-1 RNA~     quantitative assay using frozen and fresh specimens from known HIV-1 positive individuals.~   "
84456|NCT02461563|"~     This study will evaluate safety, pharmacokinetics (PK), and the ability of MK-1075 to~     suppress viral load (VL) in HCV-infected participants during 7 days of once daily dose~     administration. The primary hypothesis is at a once-daily dose that is sufficiently safe and~     well tolerated in HCV-infected participants, the mean maximum HCV RNA (log10 IU/mL) reduction~     is at least 3 log10 IU/mL as compared to baseline following multiple dose oral administration~     of MK-1075 in HCV genotype 1 (GT1) and genotype 3 (GT3) infected participants.~   "
84457|NCT02461550|"~     The investigators are investigating the use of a new cancer treatment called Irreversible~     Electroporation (IRE). This treatment delivers electrical energy between two needles placed~     in a cancer. The electrical energy causes cells to die. While this has been used in patients~     for different applications, the investigators are trying to understand how safe and well it~     works in colon cancer that has spread to the lung. Once the irreversible electroporation~     procedure is completed during the operation, the surgeon will then remove the cancer~     according to standard procedure. As part of the study, they will be measuring safety of the~     electrical energy delivered and will be reviewing the resected specimen under the microscope.~   "
84458|NCT02461537|"~     This trial compares outcome of two treatment strategies for patients with high-risk AML who~     failed to achieve or maintain a complete remission with standard therapy. Patients will be~     randomized between two strategies. The standard strategy is aimed at achieving a complete~     remission by aggressive salvage chemotherapy using high dose cytarabine and mitoxantrone, .~     The alternative is a less toxic disease-control strategy of disease monitoring and, if~     necessary, low-dose cytarabine or mitoxantrone prior to allogeneic transplantation, which~     should be performed as soon as possible.~   "
84459|NCT02461524|"~     The purpose of this trial is to evaluate the safety and effectiveness of the Endurant Evo AAA~     (Abdominal Aortic Aneurysm) Stent graft system for endovascular treatment of subjects with~     infrarenal abdominal aortic or aortoiliac aneurysms.~   "
84460|NCT02461511|"~     To Assess the impact of therapeutic education on:~        -  the occurrence of long term diabetes complications .~        -  balance of his diabetes~   "
84461|NCT02461498|"~     Existing practice in emergency departments (ED) in the United Kingdom (UK) for managing~     patients taking warfarin after a blunt head injury is variable with little research that~     supports the most appropriate way to manage these patients. The investigators aimed to~     undertake research in order to understand the range and frequency of outcomes following head~     injury in this group of patients and to develop robust clinical guidance for how they should~     be optimally managed in the future.~   "
84462|NCT02461485|"~     First experimental study (Proof Of Concept) to investigate bowel function parameters on which~     a fermented milk product with probiotics alone or in association with fibers has a potential~     effect.~   "
84463|NCT02461472|"~     A large-scale, community-based, cross-sectional study was conducted to explore the extent to~     which risk factors associated with diabetic cardiovascular autonomic neuropathy (DCAN) in~     general Chinese population. A total of more than 2000 diabetic participants were recruited by~     using multiple stages sampling (first cluster sampling and then simply sampling). Data~     involved in demographic information, clinical biomarkers such as glucose and lipids profiles,~     medical and therapy history were collected. Every participants was complete DNA extracted and~     genotyped. Diabetic Cardiovascular autonomic functions were measured by using short-term~     heart rate variability (HRV) to evaluate the outcome of DCAN. Univariate and multiple~     variables analysis have been performed to examine potential environmental and genetic risk~     factors of CAN. In addition, clinical risk model, simply screening model and nonlinear system~     model such as artificial neural network was created, respectively.~   "
84464|NCT02461459|"~     The purpose of this study is to characterize the developmental phenotype of ASD and ID and~     identify biomarkers using advanced MRI methodology predictive of ASD and ID presence and~     severity in pediatric patients with TSC. In addition, this study will be establishing~     infrastructure for the collection and storage of human bio-specimens, including genetic~     material, from TSC patients and their family members with ASD.~   "
84465|NCT02461446|"~     The purpose of this study is to determine cross-sectional and longitudinal medical,~     behavioral, and cognitive differences between PTEN ASD and other groups, as well as to~     identify cognitive, neural systems, and molecular biomarkers specific to PTEN ASD. In~     addition, this study will be creating and maintaining a biorepository and linked phenotypic~     database for PTEN ASD.~   "
84466|NCT02461433|"~     The purpose of this study is to determine whether application of an incisional wound Prevena~     trademark (TM) dressing (applies negative pressure to wounds) in the obese (BMI ≥30) surgical~     patient will reduce surgical site infections (SSI) when compared to the standard of care~     dressing.~   "
84467|NCT02461420|"~     The purpose of this study is to comprehensively characterize PMS using standardized medical,~     cognitive, and behavioral measures and to track the natural history of the syndrome using~     repeated longitudinal assessments. In addition, this study will be aiming to identify~     biomarkers using neuroimaging, including diffusion tensor imaging and identify genetic~     factors which contribute to diverse phenotypes in patients with PMS.~   "
84468|NCT02461407|"~     The purpose of this study is to compare the effects and safety of Anlotinib with placebo in~     patients with Gastric Cancer.~   "
84469|NCT02461394|"~     The user performance evaluation shows whether people with diabetes are able to obtain~     accurate measurement results with a blood glucose monitoring system. In this study, user~     performance evaluation will be performed for Contour Plus (Bayer Healthcare Diabetes Care),~     Accu-Chek Active (Roche Diagnostics), Accu-Chek Performa (Roche Diagnostics) and OneTouch~     Select Simple (LifeScan) following ISO 15197:2013, clause 8.~      The study will be performed in 2 parts. Each part will comprise testing of 2 BGMS.~      For each BGMS, measurement procedures for user performance evaluation will be performed with~     1 test meter and 1 reagent system lot by the study subjects.~      The same meter and an additional test meter will be used for double measurements performed by~     study personnel (with the same reagent system lot used by subjects).~   "
84470|NCT02461381|"~     This study aimed to estimate sensitivities and specificities of diabetic cardiovascular~     autonomic neuropathy (DCAN) diagnostic tests using the Bayesian approach without a gold~     standard in another independence dataset.The reference the values for the short-term HRV were~     calculated in the investigators' previous study (including 371 healthy subjects). This study~     dataset contained 200 diabetic patients who completed both the short-term HRV test and~     Ewing's test. Simultaneous inferences about the population prevalence and the performance of~     each diagnostic test were possible using the Bayesian approach without a gold standard.~   "
84471|NCT02461368|"~     The investigators compared the results of the ultrasound-guided anterior and posterior~     approaches to administer glenohumeral steroid injections to patients with primary adhesive~     capsulitis of the shoulder joint by a single experienced provider.~   "
84472|NCT02461355|"~     This is a randomized, crossover design trial that will compare how anodal transcranial direct~     current stimulation (tDCS) versus sham tDCS administered during multiple sessions of~     scripting therapy affects the acquisition and retention of trained scripts.~   "
84485|NCT02461173|"~     Four hundred and fifty women with unexplained infertility will be divided into 3 equal groups~     using computer generated random numbers: Group 1 will have up to 4 stimulated IUI cycles,~     group 2 will have up to 4 unstimulated cycles, women who do not become pregnant after the 4~     cycles in groups 1 and 2 will be advised to have regular intercourse at the expected time of~     ovulation. Group 3 will be the control group will be advised to have regular sexual~     intercourse at the time of ovulation for 6 months~   "
84473|NCT02461342|"~     A large-scale, community-based, cross-sectional study was conducted to explore the extent to~     which genetic, environment and its interactions associated with cardiovascular autonomic~     neuropathy (CAN) in general Chinese population. A total of more than 2000 participants were~     recruited by using multiple stages sampling (first cluster sampling and then simply~     sampling). Data involved in variables of genetic, environment were collected. Every~     participants was complete DNA extracted and genotyped by using single nucleotide polymorphism~     (SNP). Cardiovascular autonomic functions were measured by using short-term heart rate~     variability (HRV) to evaluate the outcome of CAN. Genetic analysis were employed to evaluate~     genetic variants, environmental risk factors and its interactions for CAN.~   "
84474|NCT02461329|"~     The purpose of the study is to determine whether volume therapy with a solution of gelatine~     has negative impact on coagulation, platelet function, renal function in comparison with~     crystaloid solution (Ringerfundin).~   "
84475|NCT02461316|"~     Evaluation of safety profile and tolerability of MabThera (rituximab) in combination with~     chemotherapy (fludarabine and cyclophosphamide) in the treatment of Chronic Lymphocytic~     Leukemia (CLL).~   "
84476|NCT02461303|"~     Klinefelter syndrome is characterized by primary testicular failure and progressive~     infertility. The objective of this study is to determine if sperm are present and can be~     observed in semen samples of adolescent and young adult Klinefelter patients and to determine~     whether the presence of sperm correlates with physical and/or clinically obtained hormone~     measures of pubertal development.~      This study was designed in order to answer the following questions:~        1. Is it possible to retrieve sperm for cryopreservation from semen samples of adolescent~          and young adult Klinefelter patients?~        2. Does the presence of sperm correlate with the physical and/or endocrine measures that~          are assessed during routine clinical evaluations of pubertal development in the KS~          patient population?~        3. If sperm retrieval is possible, what is the optimal age at which sperm retrieval should~          be attempted?~   "
84477|NCT02461290|"~     The primary objective is to evaluate the safety profile and tolerability of rituximab in~     combination with different chemotherapy regimens.~   "
84478|NCT02461277|"~     The aim of this study was to compare the functional capacity of exercise by six-minute walk~     test before and after thoracic surgical procedure in subjects who have undergone the~     Fast-track protocol with those who were under conventional care. Researchers want to find out~     if Fast-track is a strategy to enhance functional capacity after thoracic surgery.~   "
84479|NCT02461264|"~     Patients with acute hematological disease (acute leukemia, aplastic anemia, hematopoietic~     stem cells autologous or allogeneic ...) and hospitalized in an intensive care unit~     hematology require compensation of anemia and thrombocytopenia by blood transfusions of red~     blood packed cells (RBP) or platelet concentrates (PC).The AFSSAPS (Agence Française de~     Sécurité Sanitaire des Produits de Santé) recommendations (2002) specify the need to~     transfuse 2 RBP in case of symptomatic anemia usually for a hemoglobin between 6 and 10 g /~     dL. These recommendations allow to transfuse a single RBP for very elderly patients or in~     cases of associated heart disease (heart failure). A recent development (2012) on~     post-transfusion pulmonary edema overload recommends transfusion unit by unit for high risk~     patients.~      More recently, a Swiss team has historically compared transfusion policies in 2 139 patients~     with hematological malignancies. The first group received 2 RBP transfusion in case of~     symptomatic anemia or hemoglobin level <6 g / dL. The other group only received 1 RBP at each~     transfusion. In total 2212 units in 1548 transfusions were performed and the 1 RBP~     transfusion policy has resulted in a 25% decrease in the number of RBP used without any~     complication. In a prospective single-center pilot study, we showed that transfusing a single~     RBP was possible without increasing the side effects of anemia, without complications and~     allow an overall reduction in consumption of red blood cell units.~      Several meta-analyzes reported in intensive care or bleeding situations that a restrictive~     use of transfusions significantly reduces cardiac events, bleeding, bacterial infections and~     mortality. The number of patient to be treated to prevent one death is 33.~      The main objective is to demonstrate in a randomized trial that the restrictive strategy~     (transfusion of a single unit at each transfusion) is not inferior to the liberal strategy~     (transfusion of 2 unit at each transfusion) in terms of severe complication. Transfusion are~     performed in case of hemoglobin level <8g/dL.~      Key secondary objectives are to reduce the number of RBP used and the cost of hospitalization~     with a comparison of complications/mortality in the 2 groups.~   "
84480|NCT02461251|"~     This is a prospective, randomized and controlled study to find out if a rotational~     thromboelastometry(ROTEM) guided treatment protocol reduces the need for blood transfusions~     in major obstetric haemorrhage compared to standard care of clinical decision making,~     conventional coagulation tests and massive transfusion protocol. Secondary aim is to find out~     if ROTEM can predict the incidence of thromboembolic events in this patient group.~   "
84481|NCT02461238|"~     The purpose of this study is to assess whether fruit and vegetables vouchers combined with~     educational support may increase fruits and vegetables consumption of children aged 3 to 10~     living in vulnerable families in Saint-Denis, France.~   "
84482|NCT02461212|"~     The purpose of this study is to see if the HepaFat-Scan (a special sequence of images done in~     a MRI) can accurately detect the amount of fat in the liver.~   "
84483|NCT02461199|"~     During this prospective observational study, the investigators collect the information about~     the outcomes of fecal microbiota transplantation in patients with blood disorders, performed~     to eradicate gut colonization with multidrug-resistant (MDR) bacteria.~      Patients with blood disorders are characterized by poor diversity of gut microbiome, affected~     by repeated chemotherapy and antimicrobial treatments. This makes them vulnerable to~     colonization by pathogenic bacteria carrying genes responsible for antibiotic resistance. In~     case of gut mucosa injury and severe immune suppression, these colonizing bacteria may cause~     severe systemic infections. As the bacteria are secreted with the stool, the colonized~     patients become an epidemiologic threat to the others.~      Fecal microbiota transplantation (FMT) was shown to be very efficient in treatment of~     relapsed and refractory Clostridium difficile infection and became a standard treatment. In~     home institution, the investigators use FMT not only in case of Clostridium difficile~     colitis, but also in case of gut colonization with multidrug-resistant (MDR) bacteria. This~     is based on assumption that physiological gut flora may outcompete the pathogenic bacteria~     similarly as in case of Clostridium difficile and lead to loss of colonization. The procedure~     is performed in all patients colonized, who qualify according to listed inclusion and~     exclusion criteria .~   "
84484|NCT02461186|"~     Emerging resistance to artemisinins and their partner drugs severely threatens the treatment~     of falciparum malaria in Myanmar with artemisinin combination therapies. To inform drug~     policy, it is crucial to evaluate alternative antimalarial treatments.~      The investigators here propose a randomized clinical trial comparing parasite clearance~     parameters and efficacy of 3 days arterolane-piperaquine with standard treatment with 3 days~     dihydroartemisinin (DHA)-piperaquine in adult patients with uncomplicated falciparum malaria~     in Myanmar stratified for the presence of K13 mutation in the infecting parasite strains.~   "
84487|NCT02461147|"~     Initial cholecystectomy with intraoperative cholangiogram, followed if required by ERCP, has~     been implemented at the investigators institution as the standard management strategy for~     patients at intermediate risk of common bile duct stone migration, following a randomized~     controlled trial previously published by the same investigators team. The aim of this study~     is to prospectively analyze the outcomes of this strategy.~   "
84488|NCT02461134|"~     Chronic graft versus host diseasre (GVHD) is a serious reaction that might occur in a person~     (the host) who has received cells or organs (graft) from another person because the graft~     attacks the host's cells. Currently there are no approved therapies for chronic GVHD in the~     USA, and patients with chroninc GVHD are treated with immunosuppressant drugs. T-lymphocytes~     (a type of white blood cells) are likely to play a role in the development of chronic GVHD.~     Due to the capacity of ponesimod to block the traffic of T-lymphocytes, ponesimod may be a~     new therapeutic approach to treat chroninc GVHD.~      The main objective of this study is to assess the effectiveness and safety of several doses~     of ponesimod in subjects with chronic GVHD who did not respond to standard available~     treatments.~   "
84489|NCT02461121|"~     Patients with de novo AML enrolled in the study. Patient who has a HLA-identical donor is~     assigned to receive NST therapy with GVHD prophylaxis and who has no HLA-identical donor is~     assigned to receive MST therapy without GVHD prophylaxis.~   "
84490|NCT02461108|"~     The investigators hypothesize that monetary incentives and messaging, such as making~     nutritious foods relatively less expensive than less nutritious foods and framing the price~     difference in a positive or negative way, will influence purchasing behavior of households.~   "
84491|NCT02461095|"~     Patients with PFPS demonstrate quadriceps and hip musculature weakness, altered lower~     extremity (LE) kinematics, and decreased LE flexibility. Psychosocial factors have also been~     identified as an important factor in patients with PFPS. The authors hypothesize that an~     ordered approach addressing each of these impairments sequentially will result in greater~     improvement in PFPS symptoms. The results of the investigators pilot study assessing the~     feasibility of using a sequential approach showed a full randomized controlled trial is~     warranted, the authors now plan to proceed with a full trial. The objective of this study is~     to assess the efficacy of a sequential approach in the treatment of Patellofemoral Pain~     Syndrome.~      Methods: Patients will be randomized to a sequential treatment approach using a PFPS~     treatment algorithm (PFPS Algorithm) designed by the authors or typical physical therapy~     care. Due to the constant evaluation necessary no blinding will be performed. Patients will~     attend therapy two times per week for six weeks. Pain, Anterior Knee Pain Scale (AKPS), and~     Global Rating of Change (GROC) will be measured at evaluation and discharge, 3 month~     follow-up and 6 month follow-up.~   "
84492|NCT02461082|"~     The purpose of the study is to examine the effectiveness of different methods for the~     treatment of dysphagia in Parkinson's disease (PD). More than 80% of patients suffering from~     PD develop dysphagia during the course of their disease leading to malnutrition, loss of life~     quality, weight loss and pneumonia, which is the leading cause of death in these patients. So~     far, only a few specific treatment approaches have been investigated in PD patients with~     swallowing disorders. The investigator want to compare a 4-week expiratory muscle strength~     training (EMST), transcranial magnetic stimulation (TMS), and combination of both with a sham~     therapy. Dysphagia severity before and after intervention is measured by flexible endoscopic~     evaluation of swallowing (FEES). For the evaluation of changes in cortical swallowing~     processing the investigators apply magnetoencephalography (MEG).~   "
84493|NCT02461069|"~     This is an exploratory study, which allows analysis of multiple immune parameters derived~     from peripheral blood mononuclear cells (PBMCs) from patients with relapsing remitting~     multiple sclerosis before and during immune-modulatory treatment with dimethyl fumarate in~     comparison to PBMCs from healthy subjects.~   "
84494|NCT02461056|"~     Intravenous form of ibuprofen is recently approved by FDA and reports are rare on the~     co-administration with opioids. The investigators searched whether intravenous~     ibuprofen-hydromorphone combination is synergistic, additive, or infra-additive on~     postoperative pain using combination index (CI), dose reduction index (DRI) and isobologram.~   "
84495|NCT02461043|"~     Esophageal cancer is a highly aggressive malignancy with a poor overall outcome.~        -  Five year survival rate after radical esophagectomy is modest at about 40%.The patients~          with regional lymph node metastases have worse outcome than those without lymph node~          metastases.~        -  No standard postoperative adjuvant chemotherapy has ever been established.~   "
84496|NCT02461030|"~     This study aim is to determine the efficacy of two Oral Hygiene Regimens in the reduction of~     dentin hypersensitivity on subjects undergoing non-surgical periodontal treatment, over a~     period of 8 weeks.~   "
84497|NCT02461017|"~     The endotracheal tube (ETT) leak test (LT), or audible leak test is a widely performed~     assessment to verify appropriate tube size in neonates, infants and children. However, many~     factors are known to influence the audible leak test. Even though the test is widely~     performed, the accuracy has not been evaluated.~   "
84498|NCT02461004|"~     A randomized, open-label, 2-way crossover study to compare the pharmacokinetics and safety~     CKD-391 to coadministration Atorvastatin and Ezetimibe in health volunteers.~   "
84499|NCT02460991|"~     This is a prospective, multicenter study that will be conducted at up to 40 centers in the~     United States and Outside United States (OUS). Participants in the study will be randomly~     assigned to receive either ONCO-DOX or sorafenib treatment. This study will evaluate the~     study participants' outcomes (medical condition) after being treated with ONCO-DOX and~     compare it to those treated with sorafenib alone.~   "
84500|NCT02460978|"~     The purpose of this study is to determine if adding dapagliflozin to insulin is a safe and~     effective therapy to improve glycemic control in patients with type 1 diabetes.~   "
84512|NCT02460822|"~     This research project addresses critical gaps in cancer symptom management through the~     creation of a mobile chemotherapy symptom management application. This application will~     assess for the presence and severity of common chemotherapy side-effects and provide~     personally tailored symptom-related video and narratives to enhance self-management of cancer~     and treatment-related symptoms. This study will examine patient acceptance and use of this~     mHealth application (called MyChemoCare) in a prospective trial of cancer patients (n=60) who~     are receiving chemotherapy for colorectal cancer at the University of Michigan Comprehensive~     Cancer Center.~   "
84501|NCT02460965|"~     Rationale: Hallucinations occur in many patients with different kinds of diseases, including~     psychiatric, neurological and perceptual impairment. The origin of these hallucinations is~     only partly understood. This prevents correct prediction of treatment response and hampers~     the development of new, more effective treatment strategies.~      Different subtypes of hallucinations resulting from different neuropathology may exist across~     diagnostic entities, and be responsive to different treatment strategies. Understanding the~     origin of these subtypes with use of fMRI and EEG can help to make rational treatment~     decisions on an individual basis and enhance the development of innovative treatment~     paradigms.~      Objective: The primary objective is to find specific abnormalities on resting state fMRI~     related to the pathophysiology of different subtypes of hallucinations. Secondary objectives~     are to find EEG connectivity measures that are related to the pathophysiology of different~     subtypes of hallucinations, reveal correlating patterns of EEG and fMRI that underlie the~     experience of hallucinations across different disorders, and to examine the frequency of~     spontaneous synchronized burst activations in auditory and visual cortices using fMRI.~      Study design: The investigators intend to examine neural correlates of hallucinations over~     different disorders using resting state EEG, fMRI and sMRI in an observational study.~      Study population: A total of 140 hallucinating patients will be included, 20 of each of the 7~     different diagnostic groups. As a control group, 140 non-hallucinating patients with the same~     disorder of similar severity will be included.~      Main study parameters/endpoints: The main study endpoint is the difference in resting state~     correlates as measured with fMRI between hallucinating and non-hallucinating participants and~     between hallucinating individuals of different subtypes, namely: connectivity within the DMN~     and connectivity of the DMN to sensory cortices and the hippocampal-amygdala complex.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: Participation in the study will entail an MRI scan of 40 minutes and an EEG~     measurement of 5 minutes. Total visit time, including preparations, will be approximately 2,5~     hours. The risks associated with participation and the benefits to the individuals are~     negligible. The potential benefit to society in the future is considerable if the findings~     lead to optimization of treatment strategies and treatment response.~   "
84502|NCT02460952|"~     The purpose of this study is to investigate the prevention of Pulmonary Embolism in Patients~     who With General Anesthesia Operation in Perioperative Period.~   "
84503|NCT02460939|"~     The purpose of this study is to investigate the changes of the pulmonary vessel disease and~     its metabolism of small molecules.~   "
84504|NCT02460926|"~     This study has compared quadrant scaling and root planing (Q-SRP) versus intensive treatment~     performed within 24 hours (FM-SRP) in terms of acute phase responses following treatment of~     periodontal disease. The primary aim was to compare the differences in CRP acute increase~     following FM-SRP versus Q-SRP therapy (24 hours after therapy). Secondary outcomes included~     changes in a broad array of inflammatory and endothelial injury markers between groups.~     Patients were randomly assigned to either FM-SRP and Q-SRP. Data indicated that non-surgical~     periodontal therapy performed within 24 hours induced greater perturbations of systemic~     inflammation compared to conventional treatment.~   "
84505|NCT02460913|"~     Inadequate pain management is a common problem encountered in ED settings. Pain relief~     medications use is often limited by their side effects. Evidence suggests that non~     pharmacologic pain relief techniques such as acupuncture can play a central role to treat~     pain in acute conditions, but their application is still scarce.~   "
84506|NCT02460900|"~     The single greatest health behavior change that could improve cardiovascular morbidity and~     associated mortality is to assist people living with HIV/AIDS who smoke to quit. The~     investigators will use a factorial design to evaluate the most promising behavioral and~     pharmacologic treatments aimed at achieving maximal efficacy for smoking cessation among~     people living with HIV/AIDS who smoke. Results of this study will provide crucial, real world~     evidence of the best way for healthcare providers to help smokers living with HIV/AIDS quit~     smoking.~   "
84507|NCT02460887|"~     The purpose of this study is to verify that induction gemcitabine and cisplatin plus~     intensity-modulated radiotherapy (IMRT) is non-inferior to concurrent weekly cisplatin plus~     IMRT for patients with locoregionally advanced nasopharyngeal carcinoma (NPC).~   "
84508|NCT02460874|"~     Primary Objectives:~      Pilot Portion: To determine the feasibility and safety of administering oral glyburide to~     non-diabetic patients receiving stereotactic radiosurgery (SRS) for newly diagnosed brain~     metastases.~      Randomized Portion: To determine the number of patients with newly diagnosed brain metastases~     who have an increase in edema as measured on volumetric FLAIR imaging and the number of~     patients that require dexamethasone administration (or any corticosteroid administration with~     the purpose of treating cerebral edema) from the day of SRS to one month follow-up MRI in the~     group receiving glyburide versus placebo.~   "
84509|NCT02460861|"~     This project is about the detection of occult tumor cells in surgical margins of radical~     prostatovesiculectomy by analysing the methylation status of Glutathione S-transferase P 1~     (GSTP1). After gland excision specimens are obtained from 9 defined areas of the prostatic~     fossa. The biopsies are divided into two parts. One part used for histopathological analysis~     and the other part for moleculargenetic analysis. Results will be correlated e.g. with tumor~     stage, Gleason Score and prostate specific antigen (PSA).~      The prostate-cancer-negative control group with bladder cancer.~   "
84510|NCT02460848|"~     Cash transfer, aims to strengthen food security for vulnerable households by giving families~     enough purchasing power to consume an adequate and balanced diet, maintain a good standard of~     hygiene, access health services, and invest in their own means of food production in addition~     to their children's growth and development.~      While cash transfer to vulnerable households has shown a long-term positive impact on growth~     and on malnutrition-related mortality in children aged 0-5 years, there is little conclusive~     evidence their effectiveness in Sub-Saharan Africa that cash transfer has a direct effect on~     the Community-based Management of Acute Malnutrition (CMAM). Here, the investigators will~     perform a cluster-randomized trial to investigate during 6 months the effects of~     unconditional cash transfers on the management of severe acute malnutrition (SAM) in children~     from 6 to 59 months according to the national protocol in the Democratic Republic of Congo.~   "
84511|NCT02460835|"~     This is a pilot single arm study with the primary endpoints of feasibility and preliminary~     estimates of safety and efficacy. This protocol builds on over 25 years of experience with~     high dose liver RT (Radiation Therapy), and in particular adaptive RT aimed at adjusting the~     global radiation dose based on a patient's measured sensitivity to treatment. This current~     protocol uses functional imaging and specialized radiation planning techniques to spare~     highly functional portions of the liver to preserve function. The investigators feel this~     will further improve the safety and efficacy of RT for all patients by customizing treatments~     to each. If this approach is promising, the investigators will proceed to a phase II~     randomized study of standard versus spatially and dosimetrically adapted RT.~   "
84522|NCT02460692|"~     This study will involve treating low back pain associated with nerve injury with oral~     delta-9-tetrahydrocannabinol (Δ9-THC) or whole plant cannabis for eight weeks. Research~     subjects will consume either oral Δ9-THC (dronabinol), vaporized 3.7% Δ9-THC/5.6% CBD, or~     placebo. An analysis will then be determined to assess the risk--benefit ratio of dronabinol~     and vaporized 3.7% Δ9-THC/5.6% CBD .~   "
84513|NCT02460809|"~     This study assesses telerehabilitation in people with chronic stroke using a combination of~     noninvasive brain stimulation and finger tracking training. Telerehabilitation allows~     patients to train in their own home which also allows for longer training periods than what~     is currently allowed clinically. Noninvasive transcranial direct current stimulation (tDCS)~     uses two surface electrodes connected to a small battery that will be attached to the head.~     This will be used to modulate neuronal excitability. With sensors attached to fingers and the~     wrist, the patient will move the joints to track a target displayed on a screen. The combined~     treatment will be applied in two experiments. The first will be on 3 patients coming to our~     lab and the second on 3 patients in their home, both under supervision. We will integrate the~     two components and test the resulting and novel treatment system for technical feasibility~     and safety, which will set the stage for future efficacy studies under federal grant support.~     We hypothesize that the developed system will be safe and feasible.~   "
84514|NCT02460796|"~     BACKGROUND: Motor symptoms associated with Parkinson's disease may impair one's independence~     and ability to perform daily activities consequently decreases quality of life. Hippotherapy~     has been shown as an effective treatment to improve function in daily activities and quality~     of life in other neurological populations, thus a study was conducted to assess the effects~     of hippotherapy in people with Parkinson's disease.~      METHODS: Nine volunteers formed the treatment group which participated in a ten-week~     hippotherapy program, and nine individuals formed the control group (attended a ten-week~     series of lessons on Parkinson's disease). Outcome measures included 30-second chair stand~     (as a measure of strength-endurance), gait velocity (during 10m walk test) and health-related~     quality of life.~   "
84515|NCT02460783|"~     Background:~      - Insulin removes sugar from the blood to use for energy. Insulin resistance means that cells~     may not respond to insulin normally. It can lead to serious diseases. Researchers want to see~     how diet affects insulin resistance, weight, and brain chemicals related to Alzheimer s~     disease.~      Objectives:~      - To compare two forms of diet and their effects on insulin resistance and the brain.~      Eligibility:~      - Women ages 55 70 with insulin resistance.~      Design:~        -  This study requires 6 clinic visits over 9 12 weeks. Participants must fast before~          visits.~        -  Visit 1, screening:~        -  Medical history, physical exam, and blood and urine tests.~        -  Participants will get a wrist device to wear for 4 days.~        -  Visit 2:~        -  Weight and waist measurement.~        -  Blood drawn.~        -  Questionnaires and thinking tests.~        -  Lumbar puncture. Skin will be numbed and a needle inserted between bones in the back~          will remove <TAB>fluid.~        -  Participants will drink a nutrition shake. Blood will be taken 12 times over 4~          <TAB>hours through a thin tube in <TAB>the arm.~        -  Brain MRI. Participants will lie on a table that slides in and out of a cylinder in a~          strong magnetic field. <TAB>They will have a coil on their head and may do tasks.~        -  Participants will get advice about healthy eating and be randomly put in one of 2~          groups. One group will get <TAB>nutrition shakes to drink.~        -  Visits 3 5:~        -  Weight and waist measurements, vital signs, blood draw, and questionnaires.~        -  Between visits, participants will get a call or email to check how they are doing.~        -  Visit 6: Repeat of visit 1.~        -  Participants will wear the wrist device for 4 more days, have a follow-up contact, then~          the study is finished.~   "
84516|NCT02460770|"~     Left Ventricular Assist Devices are commonly used to assist failing hearts as a bridge to~     transplantation or for long-term support. The purpose of the MESenchymal stem cell therapy~     and Left Ventricular Assist Device program is to improve heart function with stem cell~     therapy and attempt to wean patients from HeartMate Left Ventricular Assist Device.~   "
84517|NCT02460757|"~     In this study the investigators examine the glottic width and the respiratory flow at rest in~     patients with various lung disease. The investigators postulated that a positive expiratory~     pressure is created through the narrowing of the glottic width in patients with~     hyperinflation.~   "
84518|NCT02460744|"~     The investigators at PGIMER have been practicing hypofractionation radiotherapy with a dose~     of 35Gy/15#/3wks to the chest wall in post mastectomy and 40Gy/16#/3wks in breast~     conservation in breast cancer patients for the last 4 decades. It is also a routine practice~     in UK and few centers in Canada. Hypofractionation reduces treatment time to half while~     maintaining cosmesis and gives control rates equal to conventional fractionation. As breast~     cancer is a leading cancer in females and radiation therapy is an important part of its local~     management, hypofractionation help the radiation centers worldwide to meet the growing need~     for radiation in breast cancer, particularly in developing countries where resources are~     limited. It also reduces the financial burden on the patient and family.~      In this study the investigators want to reduce the treatment duration from 3 weeks to 2~     weeks. The study will include 20 patients with breast cancer post mastectomy or after breast~     conservative surgery to be treated with a radiotherapy dose of 34Gy in 10 fractions over 2~     weeks. Patients will be assessed for acute radiation toxicity weekly during treatment and~     after one month of completion of treatment.~   "
84519|NCT02460731|"~     This is a phase 1, multi-center, open-label study of the safety, tolerability,~     pharmacodynamics, and preliminary efficacy of young (<30 years of age) healthy male donor~     plasma transfusions in patients with PSP. Up to 10 subjects will receive once monthly 4-unit~     transfusions of young healthy male donor plasma for 6 months.~   "
84520|NCT02460718|"~     It is unclear whether peer coaching is effective in minority populations living with diabetes~     in hard-to-reach, under resourced areas such as the rural South. We examined the effect of an~     innovative peer coaching intervention plus brief education vs. brief education alone on~     diabetes outcomes.~   "
84521|NCT02460705|"~     Currently enrolling only patients with Ulcerative Colitis. Enrollment and experimental~     treatment of patients with Crohn's Disease stopped for a safety evaluation.~      This is a prospective, open label pilot study in which patients with symptoms of Inflammatory~     bowel disease will receive FMT therapy delivered via colonoscopy.~      The investigators hypothesize that FMT is a safe and effective treatment for patients with~     inflammatory bowel disease. The aims are:~        1. To determine if symptoms of inflammatory bowel disease can be successfully treated by~          Fecal Microbial Transplantation.~        2. To determine if endoscopic appearance of colon or ileum improves following treatment by~          Fecal Microbial Transplantation.~   "
84523|NCT02460679|"~     Open label study with EPI-589 and ALS subjects~   "
84525|NCT02460653|"~     1. To determine the lowest nasal cannula flow rate in which upper airway deadspace is~          reduced. Hypothesis - The lowest flow rate of high flow nasal cannula (HFNC) will reduce~          upper airway (extrathoracic) deadspace and improve respiratory efficiency by reducing~          transcutaneous CO2 and/or lower respiratory rate.~        2. To determine the lowest nasal cannula flow rate in which regional distribution (as~          defined by EIT) of ventilation changes. Hypothesis - Moderate to high flow rates will~          create positive pressure that leads to improved regional distribution of ventilation.~   "
84526|NCT02460640|"~     Single-center study in order to assess whether the tap block can make extremely beneficial in~     terms of reducing the acute and chronic pain as well as for use of opioids and side effects~     related to it in patients undergoing surgery to minimally invasive partial nephrectomy.~   "
84527|NCT02460627|"~     More than half of the patients suffer from intensive pain 1-2 days after arthroscopy in the~     knee. Walking function and physical activities are affected by this intensive pain although~     local anaesthetic is given in the joint and soft tissue.~      The patients are often discharged on the same day as the arthroscopy takes place depending on~     their ability to walk with or without assistive technology.~      It is a well-known fact that the patient is given a dose of morphine, analgesics or an ice~     pack on a painful knee to reduce pain intensity. The aim of the project is to study whether~     pain intensity and analgesics can be additionally reduced by giving local anaesthetic by~     means of an adhesive tape placed on the skin instead of giving morphine, analgesics or ice~     pack on a painful knee.~      The researchers plan to include a cohort of 180 patients: 60 patients having a meniscus~     sutured, 60 patients having meniscus tissue removed surgically, 60 patients having mucous~     fold removed surgically.~      This study is planned to be a pilot study in order to complete a future large medical science~     study.~   "
84528|NCT02460614|"~     The purpose of this study is to compare the immediate effects of retrograde rhinopharyngeal~     clearance with nasopharyngeal aspiration in children admitted with acute viral bronchiolitis.~     The investigators selected children, up to 12 months old, admitted for acute viral~     bronchiolitis. Patients were divided in aspiration group (AG), submitted to nasopharyngeal~     aspiration, and clearance group (CG), submitted to retrograde rhinopharyngeal clearance with~     physiological solution (0.9%) instillation (RRC) technique. In both groups children were~     evaluated three times in the same day in order to verify cardiorespiratory parameters,~     clinical score of respiratory dysfunction and adverse effects.~   "
84529|NCT02460601|"~     The study aims to verify the efficacy and safety of Qizhiweitong granule on Chinese patients~     with functional dyspepsia diagnosed by the Rome III criteria. It includes two subtypes of~     functional dyspepsia, postprandial distress syndrome or abdominal pain syndrome.~   "
84530|NCT02460588|"~     Acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF) is a major event of IPF with an~     annual incidence between 5 and 10% and is responsible for the death of one third of IPF~     patients. When AE-IPF occurs, it is associated with poor survival with an overall mortality~     at 3 months upper of 50%. To date, no treatment has been proved to be effective in AE-IPF but~     the efficacy of cyclophosphamide (CYC) on survival has been suggested, mainly by~     retrospective series and needs to be confirmed. This confirmation is mandatory to improve~     prognosis of AE-IPF but also to avoid unsuspected deleterious effect as it as been shown with~     immunosuppressor in stable IPF.~   "
84531|NCT02460575|"~     Phase I double blinded randomized trial of the safety and tolerability of Lactobacillus~     reuteri DSM 17938 given for five successive days in healthy children. Sixty children will~     receive study product at a treatment to placebo ratio of 2:1 and followed for 3 months for~     safety outcomes.~   "
84532|NCT02460562|"~     The purpose of this study is to determine whether a novel material of S-PRG fillers~     containing in a daily-used resin denture base and their capability of fluoride release and~     recharge to elevate the salivary fluoride level and prevent dental caries in Thai middle-aged~     patients between 35-60 years of age who wear the resin denture.~   "
84533|NCT02460549|"~     The purpose of the study is to build and assess the feasibility of a therapeutic education~     program, constructed in collaboration with the urologists of the University Hospital of Saint~     Etienne. The aim of this therapeutic education program is to delay the onset or to reduce the~     amplitude of the development of insulin resistance and side effects of androgen deprivation~     therapy in patients treated with androgen deprivation in the context of an evolutive prostate~     cancer.~   "
84534|NCT02460536|"~     Attention biases in threat processing have been assigned a prominent role in the etiology and~     maintenance of anxiety disorders. Attention Bias Modification Treatment (ABMT) utilizes~     computer-based protocols to implicitly modify biased attentional patterns in anxious~     patients. This is a double-blind randomized controlled trial of ABMT for clinically anxious~     10-18 year-olds. Participants will be assessed using clinical interviews and parent- and~     self-rated questionnaires before, in the middle and after twelve sessions of ABMT or control~     groups, and again at ten-week follow-up. Outcome measures will be anxiety symptoms and~     depression as measured by gold standard questionnaires as well as structured clinical~     interviews with youth and their parents. Attentional threat bias, Attentional control and~     interpretation of ambiguous information will also be measured to explore potential mediators~     of ABMT's effect on anxiety. The investigators expect the findings to inform pathways to~     treatments for anxious children and to provide initial information on mechanisms of ABMT~     efficacy.~   "
84535|NCT02460523|"~     Evaluation of the best line of treatment of borderline CBD stones associated with gallbladder~     stones whether by conservative treatment or endoscopic stone extraction as regard complete~     clearance rate of the CBD stones followed by laparoscopic cholecystectomy. The secondary~     outcomes are overall complications related to each approach, technical difficulties and~     conversion rate during laparoscopic cholecystectomy and cost benefit relationship of each~     line of treatment.~   "
84569|NCT02460081|"~     Study PDA-002-DFU-003 is a Phase 2, multicenter, randomized, double blind,~     placebo-controlled, dose range finding study in subjects who have diabetic foot ulcer (DFU)~     with peripheral arterial disease (PAD). The study will enroll approximately 24 subjects. This~     study will investigate the hemodynamic effects, clinical efficacy, and safety of 3 monthly~     intramuscular (IM) injections of PDA-002 in subjects who have DFU with PAD.~   "
84570|NCT02460068|"~     This Phase 3, open-label, triple arm study aims to evaluate the overall survival (OS) of~     fotemustine versus the combination of ipilimumab and fotemustine or the combination of~     Ipilimumab and nivolumab in patients with metastatic melanoma with brain metastasis.~   "
84536|NCT02460510|"~     Patients with ALF (Acute liver Failure) would undergo a detailed clinical evaluation.~     Information would be collected regarding the onset and duration of symptoms, etiology, and~     severity of disease, other baseline clinical features, demographic characteristics, routine~     biochemical and hematological investigations. Patients would also be screened for the~     assessment of raised intracranial hypertension by either clinical or neuroimaging or by ONSD~     (optic nerve sheath diameter) and TCD (Transcranial doppler ultrasonography). Patient found~     to be having risen ICP (Intra Cranial Pressure) would be randomized in the two groups of the~     study. The group A would receive intravenous mannitol 20 to 30 minutes every 4 hourly where~     as those in the group B would be given 3% hypertonic saline as continuous infusion at a rate~     of 25ml /hr and titrated q4 hrs per sliding scale to achieve a target serum sodium level of~     144-155 mmol/L .Both the groups would receive other supportive measures such as head end~     elevation, oxygen supplementation, dextrose infusion to maintain normoglycemia standard~     medical treatment.~   "
84537|NCT02460497|"~     The purpose of this study is to characterize the effect of Minoxidil 2% Solution and~     Botanical Hair Solution Regimen in women with thinning hair and female pattern hair~     loss/androgenic alopecia (Ludwig I and II).~   "
84538|NCT02460484|"~     Autologous human umbilical cord blood (hUCB) stored at Cord Blood Registry will be given to~     children who have suffered from a Perinatal Arterial Ischemic Stroke. The aim is to determine~     if hUCB infusion is safe, if late functional outcome is improved, if hUCB treatment improves~     physiologic response in the child's SSEP & EEG, and the effect of hUCB infusion in altering~     anatomic findings on MRI.~   "
84539|NCT02460471|"~     Phase II prospective study or Palliative Radiotherapy of 25 Gy in 5 fractions, Intensity~     Modulated, for frail patients with incurable head and neck cancer. Comprehensive Quality of~     life (QLQ-C30, head and neck module, QLQ C15 PAL) and toxicity data (CTCAE v 4.0) collected.~   "
84540|NCT02460458|"~     A 5 - year International Registries and Prospective Study on VWD Type 3, aimed to assess~     number, types and risk factors for bleeding and the efficacy and safety of VWF concentrates~     used to treat VWD patients .~   "
84541|NCT02460445|"~     AIMS To study the effects of the decrease in iron tissue depots after scheduled bloodletting~     on insulin sensitivity, carbohydrate metabolism, classic and non-classic cardiovascular risk~     factors in patients with functional hyperandrogenism (polycystic ovary syndrome & idiopathic~     hyperandrogenism) on standard treatment with combined oral contraceptives (COC) according to~     usual clinical practice.~      METHODOLOGY~      Open label, controlled, parallel, prospective study of 12 months of duration, with 2~     randomized arms of follow-up:~      i) Intervention Group: Patients with functional hyperandrogenism on standard COC treatment~     randomly allocated to perform scheduled phlebotomies from the third month of treatment to the~     end of the study (3 times with a 3-month interval between them).~      ii) Control Group: Patients with functional hyperandrogenism on standard COC treatment~     randomly allocated to follow-up without bloodletting.~      The whole group of patients will undergo a comprehensive anthropometric and hormonal~     assessment, evaluation of classic cardiovascular risk factors (insulin sensitivity and~     carbohydrate metabolism after a standard oral glucose test- 75 g), lipid profile, ambulatory~     and office blood pressure monitoring, proinflammatory profile, oxidative stress status,~     autonomic function assessment, and iron-related metabolism parameters at baseline, after~     3-month COC treatment and after reduction of iron tissue depots plus OC in the Intervention~     Group of patients, and throughout follow-up under treatment with COC in the Control Group of~     patients. If a significant relationship between circulating hepcidin levels and elevated~     ferritin concentrations is observed, a study of the potential influence of~     mutations/polymorphic variants of hepcidin gene on ferritin values will be performed as well.~   "
84542|NCT02460432|"~     The purpose of this study is to compare the effectiveness and safety of Niti-S Mira-Cover III~     Biliary Stent with Comvi Biliary Covered Stent for the treatment of malignant biliary~     obstruction.~   "
84543|NCT02460419|"~     This multicenter, randomised, phase 3 study is to evaluate the survival benefit of~     maintenance capecitabine plus best supportive care versus best supportive care for metastatic~     nasopharyngeal carcinoma patients after disease controlled with TPC palliative chemotherapy.~   "
84544|NCT02460406|"~     This study is aimed to investigate effectiveness of progressive functional strength training~     protocol (functional squat system with virtual reality in leg press, plyometric exercises,~     exercises with Bosu ball & heel-rise exercises) on Body Functions and activity in children~     with unilateral spastic Cerebral Palsy (CP) by applying current guidelines. According to~     literature, there are studies that investigate the effects of functional strength training in~     children with CP. But there is no randomized controlled trial, explore the effects of~     progressive functional strength training protocol on body functions and activity on~     unilateral spastic CP. Hypothesis of this study is that progressive functional strength~     training protocol improves performance-related physical fitness, gross motor function,~     dynamic, balance, muscle tone and muscle strength in unilateral spastic CP.~   "
84545|NCT02460393|"~     This study is a randomized, double-blind and placebo-controlled trial with healthy subjects.~     There are 6 Groups as follows: 5mg, 15mg, 30mg, 50mg, 75mg, 100mg, and each group includes12~     people. A single subcutaneous injection will be administrated starting from the low dose~     group (in accordance with 5mg, 15mg, 30mg, 50mg, 75mg, 100mg administered subcutaneously).~     Pharmacokinetics and pharmacodynamics data will be collected; drug metabolism and~     pharmacokinetics characteristics will be analyzed. Drug safety and tolerance for subjects~     will be evaluated.~   "
84571|NCT02460055|"~     The purpose of this study is to conduct a randomized clinical trial to compare the incidence~     of dysphagia in patients receiving general anesthesia with and without an endotracheal tube~     for Upper gastrointestinal endoscopy. If the incidence of dysphagia is found to be increased~     following endotracheal intubation for this procedure it could influence the investigators~     practice as anesthesiologists and may mandate the future routine use of laryngeal tracheal~     application of lidocaine at the time of intubation for example.~   "
84572|NCT02460042|"~     The aim of the study is to assess the safety and efficacy of the paclitaxel-releasing balloon~     catheter SeQuent® Please OTW to treat de novo and restenotic lesions in peripheral arteries.~     It is the intention of this trial to treat suitable target lesions with drug coated balloon~     (DCB) only.~   "
84546|NCT02460380|"~     Polycystic Ovary Syndrome (PCOS) affects 5 to 10% of women of reproductive age. It is~     characterized by a cluster of hyperandrogenism, hyperinsulinemia, menstrual dysfunction,~     hirsutism and infertility. Although the pathogenesis of PCOS is unknown, accumulating~     evidence suggests that transforming growth factor-β (TGF-β) dysregulation may be implicated.~     TGF-β is the prototype member of the TGF-β superfamily of proteins. TGF-βs exert a diverse~     range of biological functions regulating cell proliferation, angiogenesis, fibroblast~     activation and tissue fibrosis. PCOS ovaries show all the hallmarks of TGF-β upregulation,~     including increased collagen deposition in ovarian stroma and theca, supported by increased~     vascularity. Consistent with this, The investigators recently showed that TGF-β1 is increased~     in serum of PCOS women while its circulating receptor soluble endoglin (sENG) is decreased,~     resulting in greater TGF-β1 bioavailability. PCOS patients also have decreased vitamin D~     levels, and vitamin D treatment has been previously shown to improve various clinical~     parameters in PCOS women, including glucose intolerance, hypertension and androgen levels.~     Interestingly, vitamin D has been shown to decrease TGF-β1 levels in several diseases where~     TGF-β1 is elevated, including myelofibrosis. Therefore, the investigators hypothesize that~     vitamin D treatment of PCOS women will result in a decrease of serum TGF-β1 levels~     concomitant with improvement in clinical disease parameters. In addition, the investigators~     hypothesize that improvement in clinical disease parameters will correlate with changes in~     TGF-β1 bioavailability. Our aim in the present study is to investigate the effects of vitamin~     D treatment on serum TGF-β1/sENG levels in PCOS women, and assess whether changes in~     TGF-β1/sENG levels following vitamin D treatment correlate with clinical disease in these~     women. For this end, PCOS patients who are vitamin D-deficient will be treated with vitamin D~     and their serum levels of TGF-β1 and its sENG receptor will be measured before and after~     treatment. In addition, clinical disease parameters will be recorded before and 4 months~     after treatment, including serum glucose and insulin levels, serum androgen levels, and blood~     pressure.~      The proposed study aims to identify a putative link between vitamin D and TGF-β1 in the~     context of PCOS, and provide a novel molecular explanation for the beneficial clinical~     effects of vitamin D on PCOS patients.~   "
84547|NCT02460367|"~     This is a Phase 1/2 trial using indoximod, an inhibitor of the immune checkpoint pathway~     indoleamine 2,3-dioxygenase (IDO), in combination with Tergenpumatucel-L immunotherapy and~     Docetaxel to treat subjects with advanced Non-Small Cell Lung Cancer (NSCLC). From a~     practical standpoint, a successful tumor immunotherapy will likely require a combination~     treatment with additional therapeutic interventions that both activate an immune response and~     remove redundant mechanisms of tolerance maintenance. This clinical trial utilizes the~     combination of the chemotherapeutic agent, docetaxel, plus two investigational methods of~     cancer immunotherapy: the first, tergenpumatucel-L, is intended to educate the human immune~     system to recognize the abnormal components found in lung cancer cells, resulting in an~     immune response intended to destroy or block the growth of the cancer; and the second, the~     IDO inhibitor Indoximod, will overcome tumor-induced immune suppression.~      The goal of this study is to assess the progression-free survival (PFS) and overall survival~     (OS) rates in this patient population. This study will provide a foundation for future trials~     testing indoximod combined with tergenpumatucel-L.~   "
84548|NCT02460354|"~     The purpose of this study is to determine whether metformin can increase urine concentration~     (osmolality) and decrease the amount of urine in patients with congenital nephrogenic~     diabetes insipidus (NDI).~   "
84549|NCT02460341|"~     This project investigates the effects of a single dose of ondansetron on brain function in~     healthy adults. The investigators hypothesize that there will be a dose-dependent reduction~     in activation of the insula and somatosensory brain regions associated with the use of~     ondansetron.~   "
84550|NCT02460328|"~     -  Evaluate about age of resolution in immune defect in 22q11.2 Deletion Syndrome~        -  Incidence of immunodeficiencies in 22q11.2 Deletion Syndrome~   "
84551|NCT02460315|"~     Approximately 10-15% of all patients with gallstones have coexisting common bile duct (CBD)~     stones. However CBD stones can also be formed in the absence of gallbladder stones. The~     current standard of treatment for calcular obstructive jaundice is endoscopic removal of the~     stones. Endoscopic sphincterotomy (ES) is widely accepted as the treatment of choice for~     patients with CBDS. Stone extraction is successful in up to 97% of patients The time interval~     between ERCP and laparoscopic cholecystectomy (LC) is a matter of debate that may vary from~     days to months. Some retrospective and other prospective studies have investigated this issue~     without sharp clue or definite conclusion This study planned to compare early LC (within~     admission) versus late LC (after 1 month) after ERCP as regard technical difficulties and~     surgical outcomes.~   "
84552|NCT02460302|"~     Atrophic vaginitis affects the majority of post-menopausal women. It is characterized by~     dryness and inflammation of the vagina, with thinning of the vaginal tissues. Atrophic~     vaginitis is caused by the decreased effect of estrogens post menopause. Traditionally, local~     estrogens have been used to treat atrophic vaginitis~      Studies have shown that there are progesterone receptors in vaginal tissues. The use of~     progesterone to treat atrophic vaginitis has not yet been studied. However, its use has been~     studied in other populations including as a fertility medication in pregnant women.~      There is a significant group of women who cannot use, choose not to use, or do not respond to~     estrogenic therapies. The goal of this study is to evaluate the efficacy of vaginal~     progesterone in the treatment of urogenital atrophy, compared to placebo. This study is a~     randomized, double-blind, placebo controlled trial. The ultimate goal is to expand the~     treatment options for patients with symptoms of vaginal atrophy.~   "
84553|NCT02460289|"~     The purpose of this study is to characterize the effect of Minoxidil 5% Foam and Botanical~     Hair Solution Regimen in men with thinning hair and male pattern hair loss/androgenic~     alopecia (Norwood III & IV).~   "
84554|NCT02460276|"~     In this trial, patients with mantle cell lymphoma will be included, treatment with~     lenalidomide, rituximab and ibrutinib will be administered in an induction phase for up to 12~     cycles, cycle length 28 days. Patients with complete remission, partial response or stable~     disease will enter a maintenance phase with treatment with ibrutinib and rituximab until~     progression of disease.~      The primary objective is to evaluate overall response rate, based on PET and CT.~   "
84555|NCT02460263|"~     The purpose of this study is to evaluate the Tablo Hemodialysis System when used In-Center by~     trained individuals and In-Home by trained Subjects.~   "
84573|NCT02460029|"~     The aim of this study is the visualization of the mesh surface and the confirmation with MRI~     scan at 1 month and 13 months after standardized retromuscular incisional hernia repair with~     the visible CICAT mesh (Dynamesh®).~   "
84574|NCT02460016|"~     This study will assess the safety, tolerability, pharmacokinetics (PK) and anti-viral effect~     of single dose of AK0529 in infants hospitalized with respiratory syncytial virus (RSV).~   "
84575|NCT02460003|"~     This study evaluates the effectiveness of physiotherapy program in the treatment of cluster~     headaches. Half of participants will receive a program of physiotherapy and usual drugs,~     while the other will receive an exercise program and usual drugs.~   "
84556|NCT02460250|"~     According to the French Biomedicine Agency annual report on retrieval activities and~     transplants, 1,164 liver transplants were performed in 2011 and 1,161 in 2012. If the amount~     of brain death donors and retrieved liver grafts appears relatively stable, it remains~     clearly insufficient compared to the increasing number of patients on the waiting list for~     liver transplantation (2,462 in 2011). The median time on the waiting list before liver~     transplantation which was established from the cohort of patients registered between 2007 and~     2011 (excluding patients registered for emergency transplantation and for living~     related-donor transplantation) increased significantly from 4.4 months between 2007 and 2009~     to 6.6 months between 2010 and 2011. In order to compensate for the lack of liver grafts,~     donors acceptance criteria were broadened. For example, alternative transplantation lists~     were created with liver grafts coming from so-called marginal donors. However, despite~     these efforts, livers were retrieved on only two out of three brain death donors, i.e. in~     1,572 and 1,589 organ donors in 2011 and 2012, respectively. This is unfortunately not enough~     to meet the increasing needs in liver grafts and a growing number of patients wait each year~     for transplant. Strategic lines of improvement were defined in order to meet the 2012-2016~     transplant perspective which targets 5,700 transplants carried out in 2015 (+5% every year,~     all transplants included, with 5,023 transplants in 2012).~      According to the last consensus conference on liver transplantation of the HAS (French High~     Authority of Health) the assessment of the degree of macrovacuolar and microvacuolar~     steatosis determines the possibility to retrieve the graft or not. Liver steatosis consists~     in an accumulation of fatty droplets in hepatocytes. Its prevalence is high, ranging from 16%~     to 31% in the general population, and increases up to 46% in heavy drinkers and to 50-80% in~     the obese population. Steatosis results mostly from alcohol consumption and from metabolic~     syndrome (obesity, type 2 diabetes, hypertriglyceridemia) called non-alcoholic fatty liver~     disease (NAFLD), and is more rarely secondary to viral hepatitis or exposure to certain~     medications. NAFLD involves up to 30% of the population in Western countries and its~     prevalence is increasing. NAFLD may lead to asymptomatic steatosis, but also to~     steatohepatitis or advanced fibrosis including cirrhosis and its complications Accordingly,~     the improvement of liver grafts selection based on objective quantitative criteria which~     takes into account the degree of liver steatosis appears crucial to increase the number of~     hepatic transplants.~   "
84557|NCT02460237|"~     This study will pilot test a culturally appropriate human papillomavirus (HPV) self-test~     intervention among women from Ohio Appalachia in order to determine the feasibility of HPV~     self-testing as a potential cervical cancer screening strategy. The intervention group will~     receive culturally appropriate materials and the control group will receive standard~     materials with their HPV self-test device.~   "
84558|NCT02460224|"~     This study is to characterize the safety, tolerability, pharmacokinetics (PK),~     pharmacodynamics (PD) and anti-tumor activity of LAG525 as a single agent and in combination~     with PDR001 to adult patients with solid tumors. The study consists of a dose escalation~     phase (I) to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D)~     for LAG525 as a single agent and in combination with PDR001, and a dose expansion phase (II)~     which will characterize treatment of LAG525 as a single agent and in combination with PDR001~     at the MTD or RP2D.~   "
84559|NCT02460211|"~     Each patient who is admitted for preoperative preparation for elective open heart surgery at~     Intermountain Medical Center will be invited to participate in this study. After a written~     informed consent is obtained, patients meeting inclusion/exclusion criteria will be~     randomized 1:1 to the treatment arm or placebo/control arm. Those randomized to the treatment~     arm will receive three 50,000 unit oral doses of vitamin D3 supplementation. The first dose~     will be given the evening before surgery. The second and third doses will be given either~     orally or per NG tube on the mornings of post-op days 1 and 2. Blood will be obtained at the~     following time periods: 1) At baseline pre-procedure 12 to 18 hours before planned surgery;~     2) Post-operative day 1, 12 to 24 hours after surgery; 3) 48 hours after surgery; 4) 72 hours~     after surgery; 5) At discharge (estimated to be between 5-8 days after surgery); and 6) At~     the 6-month follow-up visit (post-surgery). Plasma levels of 25(OH) vitamin D will be~     measured on each sample.~   "
84560|NCT02460198|"~     In this study, participants with previously-treated locally-advanced unresectable or~     metastatic mismatched repair (MMR) deficient or microsatellite instability-high (MSI-H)~     colorectal carcinoma (CRC) will be treated with pembrolizumab (MK-3475, KEYTRUDA®)~     monotherapy. There will be two cohorts in this study: Cohort A and Cohort B. For Cohort A,~     participants are required to have been previously treated with standard therapies, which must~     include fluoropyrimidine, oxaliplatin, and irinotecan. Enrollment into Cohort A has been~     completed. For Cohort B, participants are required to have been previously treated with at~     least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or~     fluoropyrimidine + irinotecan +/ - anti-vascular endothelial growth factor (VEGF)/ epidermal~     growth factor regulator (EGFR) monoclonal antibody.~   "
84561|NCT02460185|"~     Evaluate the effects of the practice of maternal physical exercise on the term of pregnancy~     as a method to enhance spontaneous labor.~   "
84562|NCT02460172|"~     Study designed to compare the Zip Surgical Skin Closure device vs. conventional staples for~     wound closure following bi lateral knee replacement surgery.~   "
84563|NCT02460159|"~     This study will assess the safety and tolerability of Ezetimibe (EZ) 10 mg/Atorvastatin~     (Atora) 10 mg and EZ 10mg/Atora 20 mg fixed-dose combination (FDC) in Japanese participants~     with hypercholesterolemia uncontrolled with monotherapy of Ezetimibe 10 mg or Atorvastatin up~     to 20 mg. There is no formal hypothesis for the study.~   "
84564|NCT02460146|"~     The main purpose of this trial is to demonstrate the safety, tolerability and~     pharmacokinetics (PK) of CXA-10 and its metabolite(s) administered as multiple ascending oral~     doses over 14 days to healthy obese male volunteers.~   "
84565|NCT02460133|"~     This pilot study is crucial to determining whether treating individuals who are at high risk~     for transmission or re-infection will impact HCV reinfection rates. It will establish the~     feasibility of DAA treatment in corrections facilities, as well as delineate the underlying~     immune basis of HCV cure and reinfection.~   "
84566|NCT02460120|"~     The Archimedes System is an image-guided navigation system used to access tissue samples in~     the lungs. This study is being conducted to confirm the performance of the Archimedes System~     in patients who are scheduled for standard bronchoscopy to diagnose highly suspicious lung~     cancer or metastatic disease. Navigation to and sampling of the patient's lung cancer tumor~     is conducted.~   "
84567|NCT02460107|"~     The purpose of this study is to determine whether botulinum toxin A is effective in the~     treatment of neuropathic pain in patients with diabetic peripheral polyneuropathy.~   "
84568|NCT02460094|"~     The purpose of this study is to evaluate the safety and tolerability of multiple ascending~     intravenous infusions of BMS-986168 and to assess the pharmacodynamics of BMS-986168 on~     cerebrospinal fluid (CSF) extracellular tau (eTau) concentrations in patients with~     Progressive Supranuclear Palsy.~   "
84576|NCT02459990|"~     Assess Fetal Mortality and Malformations in Women treated with antihypertensive medication~     during preganancy. Mother - Child pairs will be analysed in a cohort selected from the UK in~     the CPRD database. Years covered are 1997 to 2014. Aim is to assess the risk of~     Antihypertensive treatment in women.~   "
84579|NCT02459951|"~     Relevant to patients with spastic hemiparesis in the hand and upper limb, this pilot project~     proposes to measure the effects of botulinum toxin injections through observation of~     performance on a functional task known as 'hand as a holder'. This task requires the person~     with hemiplegia to insert an object into the affected hand and hold it independently.~      The project aims to demonstrate reliability and validity of a digital video method that will~     be used to measure 'insertion time'. It also aims to establish initial statistical support~     for improved object insertion time into the hemiplegic clenched fist after Botox A~     injections.~   "
84580|NCT02459938|"~     The purpose of this study is to determine whether glucagon administered by microneedle patch~     is comparable to glucagon administered by injection pen in the treatment of insulin-induced~     hypoglycemia.~   "
84581|NCT02459925|"~     The MOMS Partnership aims to create MOMS Zones in New Haven neighborhoods where the hardest~     to reach families live. These MOMS Zones will have two unique features: (1) a MOMS Hub to~     deliver centralized mental health and family economic success services to the hardest to~     reach families living in New Haven's most impoverished neighborhoods, as measured by actual~     socio-economic status as well as by access to resources; (2) a neighborhood workforce of~     Community Mental Health Ambassadors (CMHAs--mothers who themselves live in New Haven). The~     MOMS Workforce Program and MOMS Mental Health Program will be offered at all three Hubs.~   "
84582|NCT02459912|"~     Men with low-risk, clinically localized, unilateral prostate cancer will be treated with~     unilateral nerve-sparing cryoablation and evaluated for the rate of potency, cancer control~     and health related quality of life outcomes after treatment.~   "
84583|NCT02459899|"~     The primary objective of this study is to define the dose leading to desirable efficacy, as~     measured by the change in hemoglobin A1C (A1C) between Baseline and Week 12.~   "
84584|NCT02459886|"~     The primary objective of the study is to evaluate the safety and tolerability of a range of~     single BIIB054 doses, administered as a single intravenous (IV) infusion, in healthy~     participants and participants with early Parkinson's disease (PD). Secondary objectives of~     the study are to assess the serum pharmacokinetics (PK) profile of BIIB054 after single-dose~     administration and to evaluate the immunogenicity of BIIB054 after single-dose~     administration.~   "
84585|NCT02459873|"~     Children with low executive function, working memory and attention skills in childhood not~     only do poorly at school, but also go on to do poorly on social, health, and financial~     indicators in adulthood.~      The rate of executive function disorders in children is vastly underestimated at 17% , even~     when taking into account two of the more widely known disorders of Attention Deficit~     Hyperactivity Disorder (11%) and Fetal Alcohol Spectrum Disorders (6%), but children of lower~     socioeconomic status are especially vulnerable due to reduced resource availability.~      As executive function, working memory and attention skills are central to success in later~     life, if children with low skills can be given targeted training to improve the skills they~     fall short on, there is potential to both improve their short-term academic performance, and~     influence long-term achievement. In fact, poor executive function skills and poor attention~     and working memory is a large predictor of poor performance even in typically developing~     children who are doing poorly academically.~      Hypothesis 1. Those with lower working memory will also have lower problem solving skills and~     lower indices of other executive functioning skills such as reasoning/problem solving.~      Hypothesis 2. Children that start with lower WM and PS will show the highest gains in~     training related performance, and such high gains on WM and PS will lead to better~     performance post-intervention compared to baseline measures of cognitive function.~      Hypothesis 3: Those who make the largest gains in WM and PS with training will show more~     retention of training gains at 6 months compared those who show lower gains.~      Aim 1. Assess working memory (WM) and processing speed (PS) skills in children and their~     inter-relationships with executive functioning skills Aim 2. Examine change in cognitive~     function in WM and PS after intensive training in WM and PS, during and immediately~     post-intervention Aim 3. Examine long-term retention of training effects on WM, PS, and~     executive functions.~      The purpose of this study is to establish an effective and targeted working memory and~     processing speed intervention in children ages 7-10 with low to average executive function~     skills, by utilizing home-based computer games specifically designed to appeal to children.~      Following institution approved consents, 60 low socioeconomic status children from Los~     Angeles will be recruited and enrolled in the study and be asked to play specific fun, but~     targeted cognitive computer games for 10 weeks.~      The results of this pilot study will establish a protocol for feasibility of improving~     executive function skills in children with underdeveloped skills and inform on sufficiency of~     sample sizes, length of interventions, and directly impact computer-based intervention~     research and cost-effective techniques in children's cognitive development within the next~     3-5 years.~   "
84586|NCT02459860|"~     The purpose of this study is to determine whether individually-administered Problem Solving~     Treatment is effective in managing depressive symptomatology in 250 primarily~     Spanish-speaking Latino patients ≥55 years of age or older with high medical comorbidity. The~     aim is to test if Programa Esperanza improves: a) problem solving skills and behavior~     activation; b) depression-related outcomes; and b) physical functioning compared to enhanced~     usual care over the course of one year.~   "
84587|NCT02459847|"~     The objectives of this pilot study are to: (1) evaluate acute effects of biofeedback and~     mindfulness training on pain, anxiety, and stress during a hand therapy visit and (2) gain~     understanding of patient perceptions, preferences, and experiences with mind-body~     interventions.~   "
84588|NCT02459834|"~     Diabetes remains one of the most important unmet prevention and treatment challenges, and the~     prevalence of diabetes continues to grow. Some functional food ingredients may hold promise~     as potential therapies for diabetes. One such functional food is allulose, which is a c-3~     epimer of fructose. Allulose is a non-caloric sugar found naturally in small amounts in foods~     such as dried fruits, brown sugar and maple syrup. Previous research has found that catalytic~     doses of fructose and allulose have been shown to decrease the postprandial glycemic~     responses to high glycemic index meals. Fructose, in exchange for other carbohydrates, has~     also been found to decrease HbA1c levels. Whether the effects of fructose and allulose are~     equivalent is of particular interest, as allulose represents a non-caloric alternative to~     fructose. The minimum 'catalytic' dose at which improvements in carbohydrate metabolism are~     observed also remains to be determined for each of the sugars in people with and without~     diabetes. This study is an acute randomized controlled dose-finding equivalence trial to~     assess the effect of fructose and allulose at 2 dose levels (5g and 10g) compared with~     control (0g) on the glucose and insulin responses to a 75g oral glucose tolerance test (OGTT)~     in healthy and type 2 diabetes participants.~   "
84599|NCT02459691|"~     The purpose of the study is to develop a culturally adapted intervention (CAI) program to~     improve weight and physical activity in overweight or obese adult Latinos at high risk for~     developing type 2 diabetes and/or cardiovascular disease (CVD) and to rigorously evaluate the~     effectiveness and implementation potential of the CAI program.~   "
84600|NCT02459678|"~     This study seeks to evaluate the readiness of HIV-infected pregnant women in Zambia to~     initiate, adhere to, and be retained in care under the Ministry of Health's Option B+ policy.~     Under a 3-phased research study the investigators will: (1) conduct formative research~     regarding readiness to start lifelong ART in the pregnant population; (2) translate the~     results of formative research into a readiness assessment tool and an enhanced adherence~     package for pregnant women eligible for Option B+ and (3) conduct an individual randomized~     trial of the enhanced adherence package.~   "
84589|NCT02459821|"~     Multiple sclerosis (MS) is the most common non-traumatic cause of neurologic disability in~     young adults,affecting mobility and ambulation in the majority of patients. At least 50% of~     individuals with MS will require an assistive device to ambulate within ten years of~     diagnosis. Impaired mobility is one of the top three factors associated with inability to~     continue working. In addition,impaired mobility and the inability to walk functionally~     translate into significant costs for personal assistance, medical complications, and lost~     wages because of unemployment. Clearly,maximizing the ability to ambulate, as well as perform~     safe and effective transfers,is a fundamental goal in the management of individuals with MS.~     None of the currently available MS disease-modifying medications have been shown to stop or~     reverse gait disability. Repetitive locomotor training is an innovative approach in gait~     disturbances in patients with MS. Only scant data on this issue is available and all the~     studies have been performed by means of treadmill training or robot assisted gait training~     (RAGT) approaches. The recent introduction of a robotic device to gait rehabilitation showed~     a significant improvement in gait ability in patients with neurological disease due to the~     possibility of being trained under a graduated body weight support condition and being being~     guided to reproduce a physiologic gait pattern.~      In 2010 a novel device called GE-O System was developed. It enables patients to repetitively~     practice walking on the floor and also climb up and down stairs. To date, the effectiveness~     of this novel device has not yet been evaluated in patients with MS. The aims of the study~     are as follows: to evaluate the effectiveness of a specific gait training program consisting~     of the GE-O System in patients with MS in improving balance and walking ability,reducing~     fatigue,the frequency of falls,the fear of falling and disability in activities of daily~     living and finally,improving quality of life.~   "
84590|NCT02459808|"~     Constipation is a common condition among patients with Guillain-Barré Syndrome. It is~     believed, that the constipation is caused by autonomic neuropathy. However, the severity of~     the constipation, and its relation to autonomic function have not previously been studied.~   "
84591|NCT02459795|"~     The purpose of this study is to compare safety and efficacy of Perrigo's drug compared to an~     FDA approved drug in the treatment of actinic keratosis.~   "
84592|NCT02459782|"~     Peribulbar anaesthesia for ocular surgery depends on the spread of local anaesthetic throught~     the orbit to be successful and has a relatively high failure rate. This study will examine a~     novel ultrasound guided approach to peribulbar anaesthesia which should extend the depostion~     of local anaesthetic by using a dual quadrant injection technique. The study will assess the~     feasibility of this technique, how successful it is and whether any obvious safety issues~     arise with its use.~   "
84593|NCT02459769|"~     The purpose of this study is to test preliminary efficacy, as well as acceptability and~     feasibility, of a dyadic exercise intervention, the current study will randomize LGBT cancer~     survivors and their non-professional caregivers as dyads to either an individual or a dyadic~     Exercise for Cancer Patients (EXCAP) intervention. The primary outcome assessed will be~     psychological distress. Analyses will involve pre-post comparisons of outcomes across the~     study arms, testing the hypothesis that a 6 week, daily, dyadic exercise intervention will~     result in greater improvements in psychological distress than an individual intervention.~   "
84594|NCT02459756|"~     Regular consumption of fruits and vegetables may improve human health and reduce the risk of~     chronic diseases, such as heart disease, certain cancers and type 2 diabetes, but the active~     components and the underlying mechanisms are poorly understood. Berry fruits are abundant in~     anthocyanins and this study aims to test the hypothesis that ingestion of an anthocyanin-rich~     blackcurrant beverage will improve markers of cardiovascular health (health of blood vessels,~     inflammation and platelet function). Further, the study will investigate the anthocyanin~     bioavailability from the blackcurrant beverage.~   "
84595|NCT02459743|"~     In this prospective multicentric study, the University of Pavia together with the Fondazione~     IRCCS Policlinico San Matteo, Pavia and the IRCCS Fondazione Maugeri, Pavia, Italy will~     provide a systematic analysis of gene mutations in hematological malignancies by using NGS~     techniques. Patients with a conclusive diagnosis of haematological malignancies according to~     WHO criteria referred to the Rete Ematologica Lombarda clinical network (REL,~     www.rel-lombardia.net) will be enrolled. The investigators will analyse genomic DNA extracted~     from hematopoietic cells at different time points of patient disease. The study contemplates~     the use of molecular platforms (Next Generation Sequencing, NGS) aimed at the identification~     of recurrent mutations in myeloid and lymphoid neoplasms, respectively. Screening of gene~     mutations by NGS will be prospectively implemented in the context of REL clinical network.~     Patient samples will be analyzed at diagnosis and sequentially during the course of the~     disease at specific timepoints. The researchers will analyze the correlations between somatic~     mutations, specific clinical phenotypes (according to the WHO classification) and disease~     evolution. This will allow to: 1) identify new recurrent genetic mutations involved in the~     molecular pathogenesis of hematological malignancies; 2) define the role of mutated genes,~     distinguishing between genes which induce a clonal proliferation of hematopoietic stem cells,~     and genes which determine the clinical phenotype of the disease; 3) identify mutations which~     are responsible for disease evolution; 4) define the diagnostic/prognostic role of the~     identified mutations, and update the current disease classifications and prognostic scores by~     including molecular parameters. A systematic biobanking of biological material will be~     provided.~   "
84596|NCT02459730|"~     This study evaluated the clinical and microbiological long-term effects of 1.25% CHX~     associated with GIC applied in primary molars using Atraumatic Restorative Treatment (ART)~     technique. Randomized controlled trial was conducted on 40 children with carious lesions that~     received ART either with GIC containing CHX or GIC only. Survival rate of restorations was~     checked at 3 days, 3 months and 1 year after their placement when the unstimulated saliva~     samples were collected for microbiological assessment of mutans streptococci (MS) counts.~     Data were analyzed using ANOVA/Tukey or Kruskal-Wallis/Mann-Whitney tests (p <0.05).~   "
84597|NCT02459717|"~     Constipation is the most frequent (prevalence, about 60%) dysautonomic non motor symptom~     affecting Parkinson's disease (PD) patients. Unfortunately, limited treatment options have~     been investigated and are now available for the management of constipation in PD. Preliminary~     data have suggested that probiotics could be help improving bowel habits but high-quality~     randomized trials are required in this area. Therefore, the investigators designed a~     randomized trial to evaluate whether the use of a fermented milk containing multiple~     probiotics strains and prebiotic fiber have a beneficial effect on constipation in PD~     compared to placebo.~   "
84598|NCT02459704|"~     The aim of this study will be evaluate clinically the use of the Semilunar Coronally~     Positioned Flap (SCPF) for the treatment of gingival recessions, with or without Enamel~     Matrix Derivative (EMD). Thirty patients will be assigned in two groups. Half of patients~     will receive EMD associated to SCPF, while the other half, will receive SCPF alone.~   "
84601|NCT02459665|"~     This is a pilot study to prepare for larger clinical trials. Sixty HIV-negative,~     non-pregnant, sexually active women aged 18-45 with bacterial vaginosis (BV) by Amsel~     criteria and/or Trichomonas vaginalis (TV) on wet mount or by culture will be treated using~     oral metronidazole for 7 days. After successful treatment, and when they are free of vaginal~     candidiasis, other curable sexually transmitted infections (STIs) and urinary tract infection~     (UTI)), they will be randomised to 4 different vaginal microbiome (VMB) maintenance~     interventions (15 per group) within 3 days of completing oral metronidazole treatment: 1)~     Behavioral 'vaginal practices cessation and safer sex' counselling only (control); 2)~     Behavioral counselling plus 500mg metronidazole pills twice per week for two months; 3)~     Behavioral counselling plus Ecologic Femi vaginal capsule, once per day for 5 days~     immediately after oral metronidazole treatment followed by thrice weekly, for two months; 4)~     Group 4: Behavioral counselling plus Gynophilus vaginal tablet, once every 4 days for two~     months. In all 3 biomedical intervention groups, vaginal product use may be ceased~     temporarily during menstruation. Participants will be asked to adhere to the interventions~     for 2 months, and VMB assessments will take place before (screening and enrolment visits),~     during (Day 7, Month 1 and Month 2 visits), and after the interventions (Month 6 visit).~   "
84602|NCT02459652|"~     Multicenter Prospective Phase II Study for Neoadjuvant S-1 and Concurrent Radiotherapy for~     Borderline Resectable Pancreatic Cancer~      RATIONALE: Borderline resectable pancreatic cancer is frequently related to a positive~     surgical margin and has a poor prognosis after resection. Neoadjuvant chemoradiation with~     intensive local effect may lead to substantial local control and prolongation of survival in~     borderline resectable pancreatic cancer.~      PURPOSE: This phase II trial assess efficacy and safety of neoadjuvant S-1 and concurrent~     radiotherapy for borderline resectable pancreatic cancer.~   "
84603|NCT02459639|"~     Using a comprehensive prospective clinical study design, the investigators intend to compare~     changes in health-related markers in patients with chronic widespread pain (CWP), undergoing~     one of two intervention packages of multimodal health care, namely anthroposophical~     integrative care (AIC) or standard care (SC), respectively. AIC combines evidence-based~     conventional care with complementary/alternative (CAM) treatments. As markers, the~     investigators will use indicators of drug utilization and sick leave, as well as constructs~     mirroring possible changes in psychological and existential factors and genomic stability~     (such as telomere length and telomerase levels).~   "
84604|NCT02459626|"~     StiffMAP-HFpEF trial is an investigator initiated, observational, single-center study that~     will evaluate whether fibrosis quantification by cardiac MRI correlates with left and right~     ventricular stiffness derived from pressure-volume analysis, aiming to clarify if cardiac MRI~     is a valid, non-invasive method to assess diastolic function in patients with Heart Failure~     with preserved ejection fraction.~   "
84605|NCT02459613|"~     Intraluminal thrombi adherent to cardiac valves or atria share a common pathophysiology~     involving the aggregation of activated platelets with phosphatidylserine (PS) expression on~     the outer layer of the thrombus. They also share common complications, i.e. damages to the~     underlying myocardium and embolic risk related to thrombus fragmentation. The diagnostic~     work-up, currently relying on morphologic imaging alone (mainly echography), lacks~     sensitivity and does not allow to differentiate between active (renewal and growth activity)~     and quiescent (scarred) thrombus. It is therefore highly desirable to develop a new approach~     able to non-invasively provide insight on the biological activity of thrombi and to detect~     embolic events in a single exam.~      Annexin V is a 36 kDa endogenous glycoprotein which binds PS with nanomolar affinity.~     Radiolabeled Annexin V has been shown to provide molecular imaging of PS expressed by~     apoptotic cells or activated platelets. The ability of the imaging agent to bind mural~     thrombus has been established in vivo in a murine model of abdominal aortic aneurysm and ex~     vivo in human. It has been also shown that radiolabeled Annexin V allowed in vivo detection~     of vegetations and secondary pulmonary emboli with high sensitivity in various animal models~     of infective endocarditis.~      A radiolabeling kit of annexin V complying with GMP requirements has been developed~     (rhAnnexine V-128, Advanced Accelerator Applications - Atreus) and is currently available.~     AnniE is a single centre, proof of concept, interventional, open, non-randomized study aiming~     at evaluating the sensitivity of 99mTc-Annexin V-128 in the detection thrombus in comparison~     with reference imaging in patients presenting with either: 1/ infective endocarditis or 2/~     atrial thrombus. The safety of the 99mTc-Annexin V-128 will be assessed in a first phase (10~     first patients enrolled). Data in relation with safety of the imaging agent will be reviewed~     by an independent Data and Safety Monitoring Board (DSMB); in case of positive answer, the~     study will continue with a second phase. The data gathered in all patients (n=120) will be~     used to determine outcome measures.~   "
84606|NCT02459600|"~     Assessment of refraction measurements in children under general anesthesia, with or without~     cyclopelgic eye-drops~   "
84607|NCT02459587|"~     This study is a randomized controlled trial (n = 500) of a new single-session intervention,~     called Crisis Line Facilitation (CLF), compared to an enhanced usual care condition on~     utilization of the Veterans Crisis Line and other mental health services as well as suicide~     attempt(s). All participants will be recruited during an inpatient psychiatric stay for the~     treatment of a recent suicidal crisis and be re-assessed at 3-, 6- and 12-months post~     baseline. If successful, the proposed study will provide key data on the potential efficacy~     of a brief tool to improve the utilization of an existing resource, the Veterans Crisis Line,~     to reduce suicidal behaviors in VHA patients.~   "
84608|NCT02459574|"~     A streamlined AF ablation procedure done without PV mapping as a daycase is more effective~     than anti-arrhythmic drugs at reducing all hospital episodes for recurrent atrial~     fibrillation.~   "
84618|NCT02459444|"~     The inspiratory muscle training (IMT) is a feasible and safe strategy for patients and~     athletes, your goal is to recondition the respiratory muscles, providing optimization of lung~     capacity, either for high performance sport as to support metabolic wear caused by illness.~     It is generally agreed the positive impact of the application of a TMI Protocol on maximal~     inspiratory pressure (MIP), this benefit encourages individuals sick since weaning from~     mechanical ventilation (MV), to the optimization of physical performance in cardiac and / or~     pulmonary rehabilitation. The TMI is based on the principles: the burden imposed on the~     muscle; the specificity of training; the reversibility of the gain and muscle atrophy.~   "
84619|NCT02459431|"~     Randomized controlled trial to determine the efficacy of different needles sizes (22G and~     21G) used in endobronchial ultrasound guided transbronchial needle aspiration~   "
84620|NCT02459418|"~     Comparative PK study after single SC application of Afolia and the reference product (US~     Gonal-f®). Objective: To demonstrate equivalence within 80%-125% margin of the reference~     product for the area under the curve (AUC) of Afolia.~   "
84706|NCT02458287|"~     This study is a multicenter, randomized study in subjects with high cholesterol receiving~     statins to assess the efficacy to lower LDL-C, the safety, tolerability and actual use of~     bococizumab and an autoinjector (pre-filled pen).~   "
84609|NCT02459561|"~     The management of obesity is challenging and obesity surgery is by far the most effective~     treatment currently available. Recent medical research indicates that it also improves the~     management of blood glucose levels in people with type 2 diabetes. Obesity surgery carries~     different risks and benefits and it is important to balance these by choosing the right~     procedure for each patient. Therefore new effective strategies to prevent and reduce obesity~     and its complications such as type 2 diabetes mellitus are needed. This study is designed to~     see whether a new device called the EndoBarrier Gastrointestinal Liner helps patients manage~     their blood sugar levels and lose weight. It is a randomised, placebo controlled trial which~     compares the potential of the EndoBarrier device with conventional drug therapy, diet and~     exercise for obesity related type 2 diabetes, and their effectiveness on metabolic state~     (HbA1c reduced by 20% and blood pressure below 135/85), weight loss, and quality of life. It~     will further evaluate whether any other conditions that may be related to obesity could~     become less severe and collect information about complications to determine the safety of the~     device. The study will also perform various measurements and tests to understand the~     underlying mechanism of the device. After an initial screening visit to determine patients~     eligibility, they will be invited for 14 subsequent visits. Patients will be randomised into~     either having the EndoBarrier device or standard medical therapy treatment for 12 months~     followed by another 12 months follow-up period. They will also be routinely seen by~     specialist dietitian who will provide dietetic support throughout the study.~   "
84610|NCT02459548|"~     The objective of the study is to compare the results of a follow-up and treatment coordinate~     and interactive program performed by the General Practitioners (GP) for Obstructive Sleep~     Apnea (OSA) patients treated with positive continuous pressure (CPAP) vs. usual control by~     sleep specialists from the sleep unit.~      METHODOLOGY: DESIGN: Randomized comparative study. It will include patients with diagnosis of~     severe OSA that should start treatment with CPAP. Participating center is Hospital~     Universitario Araba in Vitoria-Gasteiz (Spain). These patients will be randomized to two~     monitoring groups : 1 monitoring in the sleep unit; 2: monitoring in primary care~     consultations by the General Practitioners (GP), once the OSA diagnosis has been made and it~     was indicated the treatment with CPAP.~      Patients will be carried out in both groups the same follow-up visits in two study arms:~     basal, 1 month, 3 month and 6 months. PRIMARY OUTCOME: To compare the objective CPAP~     compliance treatment in the two study groups, so that use >= 4h/day is defined as good~     adherence to the treatment. SECONDARY OUTCOMES: 1)To evaluate the level of patient's~     satisfaction by visual-analogical scales and quality of life tests; 2) to establish the~     clinical improvement by somnolence and sleep scales; 3) To determine the numbers of CPAP~     complications, type, severity and duration; 4) To figure-out the level of take care of the~     CPAP machine, substitutions and complements, assistance and technical incidents; 5)~     Cost-effectiveness analysis.~   "
84611|NCT02459535|"~     Epidemiological data suggest, that not only sugar-based, but also artificially sweetened soft~     drinks may play a role in the development of diabetes.~      Recent studies in animals and humans have shown, that artificial sweeteners (AS) influence~     metabolic responses after glucose ingestion, possibly alter the intestinal microbiome and~     even modulate incretin release.~      However, it is unclear, if these findings are valid for all kinds of AS, as they are~     chemically different. Furthermore, data on human subjects are sparse and controversial.~      The investigators will therefore conduct 7 consecutive single oral stimulations with glucose~     or AS alone or a combination. Three different AS will be tested.~   "
84612|NCT02459522|"~     This study aimed to evaluate the reference values for the short-term heart rate variable~     (HRV), estimate the performance of cardiovascular autonomic neuropathy (CAN) diagnostic tests~     in the absence of a gold standard, and assess CAN prevalence in our cross-sectional dataset.~   "
84613|NCT02459509|"~     The purpose of the study is to determine if 4mcg/kg of intranasal dexmedetomidine is better~     than 2mcg/kg in successfully sedating a child prior to induction of anesthesia.~   "
84614|NCT02459496|"~     Basic treatment of type 2 diabetes should focus on diet, physical activity and lifestyle.~     Nevertheless, in early and late stage of T2DM, lifestyle intervention is mostly substituted~     by pharmacological intervention, although lifestyle modification and dietary treatment would~     be favourable.~      The researchers therefore investigate dietary strategies such as low-carb and very-low calory~     diets regarding their potential to improve metabolism and body weight in (mostly) long-term~     T2DM patients.~   "
84615|NCT02459483|"~     The purpose of this study is to assess the effectiveness of a nurse telephone interview in~     the management of cancer patients treated by oral chemotherapy. This is a multicenter~     prospective randomized controlled pragmatic interventional trial conducted in collaboration~     with two oncology care facilities. Eligible population consists of all patients suffering~     from advanced cancer and treated by oral chemotherapy except hormonotherapy. 184 patients~     will be enrolled in the study. The experimental group will receive a standard followed by a~     medical oncologist, hematologist or radiation therapist as part of routine care, and~     telephone interviews by a nurse every 14 +/- 2 days for 6 months. The control group will~     receive a standard followed by a medical oncologist, hematologist or radiation therapist as~     part of routine care.~      The effectiveness of the intervention will be evaluated by a toxicity score of the 9 most~     common side effects of oral cancer (oral mucositis, hand-foot syndrome, diarrhea, nausea,~     vomiting, pain, asthenia, rash and anorexia) officers from NCI CTCAE v4.0-(Common Toxicity~     Criteria for Adverse Events) and turned into a single composite criterion (sum of 9 Toxicity~     grades).~   "
84616|NCT02459470|"~     The aim pf this prospective study is to investigate the ability of stroke volume variation~     (SVV) and pulse pressure variation (PPV) to predict fluid responsiveness in patients~     undergoing kidney transplantation.~   "
84617|NCT02459457|"~     The purpose of this study is to determined the best scheme in paclitaxel and~     cisplatin，paclitaxel and fluorouracil，paclitaxel and carboplatin concurrent with radiotherapy~     for patients with local advanced esophageal Squamous Cell Carcinoma.~   "
84621|NCT02459405|"~     Anastomotic leak is a devastating complication of colorectal surgery. There is no widespread~     means of assessing the viability of a laparoscopic anastomosis. The investigators described~     recently the feasibility of microvascularisation assessment with near-infra red technology~     (NIR).~      The aim of this study is to look at the implementation of this technique in a wider~     prospective series of patients undergoing colorectal resection.~   "
84623|NCT02459379|"~     This is a prospective registry evaluating the safety of performing magnetic resonance (MRI)~     scans on patients who have cardiac implanted electronic devices (CIEDs). This includes~     pacemakers and implantable cardioverter defibrillators (ICDs). This is not a a new device~     approval or new MRI scanner approval, only for a registry of patients who need to have an MRI~     scan who already have an FDA approved CIED that is not currently labeled for use in~     conjunction with an MRI scan. This registry is very similar to the previously approved~     MagnaSafe Registry that is now closed to new enrollment.~   "
84624|NCT02459366|"~     The objective of three-year research is to investigate the relationship between thoracolumbar~     fascia tissue characteristics, lumbopelvic asymmetry, core muscle contractility,~     proprioception and standing balance in different ages of asymptomatic participants and~     patients with CMLBP.~   "
84625|NCT02459353|"~     Dapagliflozin improves glycemic variability in subjects with type 2 diabetes mellitus when~     added to insulin therapy. The primary objective of this study is to assess the effect of~     dapagliflozin on glucose variability compared to placebo after 12 weeks of treatment in type~     2 diabetic patients with inadequate glycemic control on insulin.~   "
84626|NCT02459340|"~     The main goal of the proposed project is to assess treatment-induced changes of~     electrophysiological and psychophysiological correlates of the capacity to regulate emotion,~     executive functions, and clinical measures in individuals with (complex) posttraumatic stress~     disorder, dissociative disorders, or borderline personality disorder in naturalistic~     inpatient and outpatient settings.~   "
84627|NCT02459327|"~     This study tests a comprehensive approach to the promotion of school readiness in low-income~     families, beginning shortly after the birth of the child, through enhancement of positive~     parenting practices (and when present, reduction of psychosocial stressors) within the~     pediatric primary care platform. The investigators do so by integrating two evidence-based~     interventions: 1) a universal primary prevention strategy (Video Interaction Project [VIP]);~     and 2) a targeted secondary/tertiary prevention strategy (Family Check-up [FCU]) for families~     with infants/toddlers identified as having additional risks. VIP provides parents with a~     developmental specialist who videotapes the parent and child and coaches the parent on~     effective parenting practices at each pediatric primary care visit. FCU is a home-based,~     family-centered intervention that utilizes an initial ecologically-focused assessment to~     promote motivation for parents to change child-rearing behaviors, with follow-up sessions on~     parenting and factors that compromise parenting quality.~      Two primary care settings serving low-income communities in New York City, NY and Pittsburgh,~     PA will be utilized to test this integrated intervention in hospital-based clinics, providing~     information about translation across venues where one of the two interventions has been~     previously used alone.~      The investigators plan to test the VIP/FCU model in a randomized trial of 400 families~     utilizing parent surveys, observational data on parent-child interactions, and direct~     assessments of children's development, at key points during intervention follow-up. Analyses~     will address questions of program impact for the integrated program across all families and~     by key subgroups.~      The largest single contribution made by this study is to test whether an integrated primary~     and secondary/tertiary prevention strategy implemented in pediatric primary care can produce~     impacts on early school readiness outcomes, including social-emotional, pre-academic, and~     self-regulation. As such, this study has the potential to provide the scientific and practice~     communities with information about an innovative approach to promoting school readiness~     skills among low-income children.~   "
84628|NCT02459314|"~     This was a multicenter, prospective, randomized, double-blinded, controlled-trial study in~     hypercholesterolemic volunteers (serum LDL-C > 130 mg/dL). Eligible subjects were randomized~     to receive either plant sterol and soluble fiber-enriched soymilk or plain soymilk 360 mL/day~     (2 packages a day) for 8 weeks. Venous blood samples were collected from the eligible~     subjects during pre-treatment (screening period; day -7), every 2 week after treatment (at~     the end of week 2, 4, 6 and 8) to test for lipid profiles and fasting blood sugar (FBS).~   "
84629|NCT02459301|"~     The purpose of this study is to test the safety of a new drug, IPH2201, to see what effects~     it has on this type of cancer.~   "
84630|NCT02459288|"~     A 4 week-duration cross-over study on Ticagrelor and Clopidogrel for the Acute Coronary~     Syndrome (ACS) and Chronic Kidney Disease (CKD) subjects, focusing on the platelet inhibition~     and safety observation.~   "
84631|NCT02459275|"~     The main objective of this project is to asses for safety, feasibility and effectiveness of~     an aggressive feeding protocol, PEP uP (Enhanced Protein-Energy Provision via the Enteral~     Route Feeding Protocol) in increasing protein and energy delivery to critically ill surgical~     patients. Our hypothesis is that an aggressive feeding protocol, PEP uP will be safe,~     acceptable, and effectively increase protein and energy delivery to critically ill surgical~     patients.~   "
84632|NCT02459262|"~     Part A: The primary objective is to evaluate the safety and tolerability of a potential~     vaccine against Group B streptococcus.~      Part B: To evaluate the long term safety profile of the GBS-NN vaccine up to one year~     following the first dose.~   "
84633|NCT02459249|"~     The objective of this study is to evaluate the effect of a healthy-habits intervention~     tailored to the cultural, economical and social context of the target population in~     cardiometabolic parameters, for a population with no access to specialized health services.~     The intervention was designed considering environmental and economic context like~     availability of food and physical activity spaces; cultural factors like social and culinary~     traditions; individual food preferences. It encompass a selected set of behavioral and~     nutritional strategies aiming to achieve control of metabolic disorders involved and to~     reduce the risk for diabetes.~      The investigators' study is a nine-month clinical intervention with randomized allocation,~     and parallel assignment. For the first six months, the participants in the control group will~     receive the treatment from the primary care service by the Health Minister as implemented by~     the local health center, and for the intervention group participants will receive a treatment~     to improve the quality of the diet and promote the practice of physical activity. Both groups~     will be reevaluated at third, sixth and ninth-months follow-up. The physician and the~     nutritionist of the study will be give the recommendations for diet and advice on exercise,~     mainly by suggesting moderate-intensity activity, such as brisk walks for at least 150~     minutes/week.~   "
84634|NCT02459236|"~     There is a significant unmet medical need for rapidly acting treatment of subjects with~     severe major depressive disorder (MDD) who have not adequately responded to antidepressant~     therapy. Alternative therapies require weeks to achieve full efficacy, may have significant~     side effects, and still fail in a high percentage of subjects. Rapid reduction of severe~     depression by pharmacological therapy is important to reduce the need for hospitalization and~     risk of self-harm and mortality. CERC-301, a highly selective, orally bioavailable,~     N-methyl-D-aspartate (NMDA) receptor subunit 2B (NR2B), also referred to as Glutamate NMDA~     receptor subunit epsilon-2 (GluN2B) antagonist, would be a therapeutic breakthrough if it~     provides rapid onset of antidepressant effects and an effect size similar to that seen with~     experimental intravenous NMDA modulators.~   "
84635|NCT02459223|"~     Present study was designed to evaluate the efficacy of the nutritional intervention, in the~     SAM (Severe Acute malnutrition)children by monitoring various Anthropometric,Biochemical~     ,Hormonal and Enzymatic parameters before and after the nutritional intervention~     treatment.This study was also intended to study possible functional role of gene HRI (heme~     regulated inhibitor) as a molecular marker for the early detection of iron deficiency anemia~     in malnourished children similarly present study has also tried to find anthropometric marker~     and different correlations among study parameters.~   "
84636|NCT02459210|"~     The purpose of this study is to test the feasibility of a modification of CET (Cognitive~     Enhancement Therapy) to address symptomatic and functional difficulties associated with~     Clinical High Risk for Psychosis (CHR).~      Cognition for Learning and for Understanding Everyday Social Situations (CLUES) is designed~     to improve cognitive functioning (e.g., memory, attention, planning, etc.) in order to~     improve school, work, and social functioning. CLUES includes the following:~        1. Computerized cognitive remediation (exercises) to improve cognition.~        2. Social-cognitive skills group designed to teach participants to act wisely in social~          situations.~        3. Individual coaching sessions designed to enhance translation of skills learned from~          computer exercises and the group into real life.~      CLUES is based on Hogarty and Greenwald's Cognitive Enhancement Therapy (CET), which was~     designed for treating individuals with schizophrenia. Research on CET for individuals with~     schizophrenia has found that CET appears to have helped participants improve cognition and~     social and work functioning.~      This study will investigate the feasibility of CLUES for young people who are showing signs~     of clinical risk for psychosis.~      Part 1: Preliminary open label trial of CLUES (n=8) to examine preliminary evidence of target~     engagement (change in cognition and social cognition), to refine assessment and recruitment~     approaches, to further optimize the treatment manual, and to ascertain feasibility and~     tolerability.~      Part 2: Preliminary randomized controlled trial of CLUES vs supportive therapy (ST) +~     computer games to explore preliminary evidence of efficacy of CLUES vs. the control treatment~     (n=30).~   "
84637|NCT02459197|"~     The purpose of this clinical trial conducted in patients suffering from chronic pain is to~     study the relationship between individual patients' profile and their analgesic response~   "
84638|NCT02459184|"~     Social processes that impact the health of individuals have been labeled the social~     determinants of health (SDOH). These are the conditions in which people are born, grow,~     live, work and age. These circumstances are shaped by the distribution of money, power and~     resources at global, national and local levels. Perhaps the most important SDOH is income~     security, a person's actual, perceived and expected income. Our objective is to carry out a~     pragmatic randomized controlled trial that evaluates the impact of an income-focused health~     promoter.~   "
84639|NCT02459171|"~     This study seeks to determine the incidence and transmission of avian influenza viruses in~     humans exposed to poultry. Enrolled subjects will be selected from five different rural areas~     (villages) in the Nile delta region in Egypt where poultry are commonly raised. From those~     study sites, 2400 healthy subjects will be monitored for 6 years with annual follow up visits~     to measure sero-prevalence and exposure variables, and more importantly, biweekly or weekly~     visits to measure incidence of infection, measure secondary transmission rates, monitor~     symptoms, and assess immunological response.~      Primary Objectives:~        -  To estimate the incidence of avian influenza (AI) in poultry-exposed human populations.~        -  To estimate sero-prevalent of AI in poultry-exposed human populations.~        -  To investigate potential risk factors associated with AI human infections in~          poultry-exposed individuals.~        -  To investigate secondary infection risk for household contacts.~      Secondary Objectives:~        -  To characterize the antigenic and genetic makeup of AI viruses infecting humans.~        -  To monitor the pathogenicity and disease severity of AI viruses causing human infections~          and the associated immune response.~        -  To investigate the serologic response following confirmed influenza virus infection.~   "
84640|NCT02459158|"~     This study is a randomized, open-label phase I study. The primary objective of this study is~     to assess the pharmacokinetic (PK) profile of ME1100 in subjects with mechanically ventilated~     bacterial pneumonia (MVBP). The secondary objective of this study is to assess the safety and~     tolerability of ME1100 for the treatment of subjects with MVBP to assess the safety and~     tolerability of ME1100.~   "
84641|NCT02459145|"~     The general consensus in sports medicine demonstrates a graduated return to activity protocol~     for individuals with post-concussion syndrome. This is commonly practiced but there is~     insufficient literature to indicate evidence-based practice. This study will provide evidence~     of the effectiveness of the clinical gradual return to exercise protocols beginning after~     diagnosis of post-concussion syndrome through standardization and measurement of outcomes.~   "
84642|NCT02459132|"~     This study evaluates the impact of a supervised 12-week high-intensity aerobic interval~     exercise program (versus a self-directed exercise usual care group) on traditional and novel~     cardiovascular disease risk factors and surrogate markers of cardiovascular- and~     overall-mortality in a population-based sample of testicular cancer survivors.~   "
84643|NCT02459119|"~     This study will test how well Regorafenib controls disease progression in urothelial cancer~     (cancer occurring in the urinary bladder, ureters, or renal pelvis) following previous~     therapy with chemotherapy.~   "
84644|NCT02459106|"~     The purpose of this study is examine the effect of fat tissue-released miRNA on skeletal~     muscle and if abnormal fat tissue-released miRNA contributes to insulin resistance in obese~     individuals. This information will be important for our understanding of how the body's sugar~     metabolism is regulated and why people who are obese become insulin resistant and are more~     likely to develop type 2 diabetes.~   "
84645|NCT02459093|"~     A comparison of the type of suture used for cesarean skin incision approximation and the~     subsequent rate of wound complications has not been widely studied. Investigators seek to~     compare poliglecaprone 25 and polyglactin 910 suture used in a subcuticular skin closure in~     Pfannenstiel incisions during cesarean birth and determine the subsequent wound complication~     rates (SSI, hematoma, seroma, wound separation).~   "
84646|NCT02459080|"~     The purpose of this study is to measure the effectiveness and safety of TD 4208, an~     investigational drug being developed to treat people with moderate to very severe COPD,~     compared to placebo, a treatment without activity.~   "
84647|NCT02459067|"~     To determine the safety, tolerability, maximum tolerated dose (MTD) and efficacy of~     ImmuniCell® in patients with melanoma, renal cell cancer (RCC) or non-small cell lung cancer~     (NSCLC). The study is an adaptive design that has 3 stages: Stage 1 - dose escalation, Stage~     2 - efficacy, and Stage 3 - confirm efficacy in one of the tumor types.~   "
84648|NCT02459054|"~     The primary objective of the study is to evaluate whether the 50cc TAH-t can safely support,~     and provide probable benefit to, transplant-eligible pediatric patients (aged 10 - 18 years)~     and can safely and effectively support transplant-eligible adult patients (aged 19 - 75~     years) at imminent risk of death from biventricular failure without experiencing permanent~     disabling, stroke-related deficits.~      The study will be conducted as a three-arm trial of the 50cc temporary Total Artificial Heart~     (TAH-t) as a bridge to transplant:~        -  The Primary Pediatric Arm of the trial will evaluate the safety and probable benefit of~          the 50cc TAH-t for transplant-eligible patients 10 through 18 years of age.~        -  The Primary Adult Arm of the trial will evaluate the safety and efficacy of the 50cc~          TAH-t for transplant-eligible patients 19 through 75 years of age.~        -  The Secondary Arm will capture pediatric and adult subjects who did not meet enrollment~          criteria for a Primary Arm, but meet the less restrictive Secondary Arm enrollment~          criteria, in order to further characterize the use of the device.~   "
84649|NCT02459041|"~     The study protocol is based on a multi-center semi-quantitative approach of EUS elastography~     data in combination with contrast-enhanced EUS, consisting of measuring SR and SH for focal~     pancreatic masses and lymph nodes, as well as several parameters of CE-EUS based on~     time-intensity-curve (TIC) analysis. A number of parameters must be taken into consideration,~     as the ROIs are still manually selected by the user. The aim of the study is to establish an~     EUS based diagnostic algorithm in patients with pancreatic masses and lymph nodes, with~     negative or inconclusive cytopathology after EUS-FNA, based on previously published results~     and cut-offs of elastography and contrast-enhancement. The proposed algorithm of sequential~     use of real-time elastography, followed by contrast-enhanced EUS could be a good clinical~     tool to help select the patients with possible pancreatic adenocarcinoma or malignant lymph~     nodes, in the setting of patients with negative EUS-FNA results.~   "
84650|NCT02459028|"~     Background:~      Chronic pain is one of the most burdensome potential consequences of a physical disability,~     such as spinal cord injury (SCI). Estimates of the incidence of chronic pain in SCI range~     between 65 - 80%. A recent pilot-study of a computer-based tailored positive psychology~     intervention showed a significant reduction in pain intensity, pain interference, pain~     catastrophizing and depression and an enhancement of subjective well-being and control over~     pain in persons with chronic pain secondary to a physical disability.~      Study Objective:~      Objective 1: To determine the efficacy of a tailored positive psychology intervention (T3P)~     in a community-based, single-blind, randomized, controlled, parallel group trial on~     subjective well-being and pain in individuals with chronic pain secondary to SCI.~      Hypothesis 1: T3P will result in (1) greater immediate and long-lasting increase in~     subjective well-being, and perceived control over pain and (2) greater immediate and~     long-lasting decrease in depression, pain intensity, pain interference and catastrophizing,~     relative to an active control treatment.~      Specific aim 1: To increase the understanding of the mechanisms underlying T3P by determining~     potential mediation effects.~      Hypothesis 2: (1) Pain catastrophizing and pain control mediate the effect of T3P on pain~     intensity, and (2) positive and negative affect mediate the effect of T3P on life~     satisfaction and depression.~      Objective 2: To identify for whom T3P is most effective by exploring potential moderator~     effects.~      Study Design:~      The proposed study is a single-blind, randomized, controlled trial with a parallel group~     design to determine the effects and mechanisms of T3P in a Swiss community sample of persons~     with chronic pain secondary to SCI.~   "
84651|NCT02459015|"~     The purpose of this clinical investigation is to confirm the medium- and long-term safety and~     performance of the chitosan-based nerve guide (Reaxon® Nerve Guide) in comparison to an~     autologous nerve graft to bridge nerve defects in the finger.~   "
84652|NCT02459002|"~     The goal of this study is to learn about the quality of life (QOL) in participants with~     advanced lung cancer.~   "
84653|NCT02458989|"~     This study looks at the difference in surgical scar outcomes between two different surgical~     incision methods during thyroid surgery: scalpel vs electrocautery. Patients who are already~     scheduled for thyroid surgery with Dr. Sam Wiseman, Endocrine Surgeon at St. Paul's Hospital,~     and that meet the eligibility criteria for this study will be invited to participate. After~     signing the informed consent form, participants will be randomized into either one of the two~     incision methods, but will not know which one they receive. There will be two follow-up time~     points: one at 6 and another at 12 months post-operative. At these time points the research~     team will send a letter to the participant asking them to rate the appearance of their~     surgical scar. They will also be asked to take a picture of their scar and send it back to~     the research team, so that the research team can make an assessment of their surgical scar.~     The study concludes when the 12 month follow-up is complete.~   "
84654|NCT02458976|"~     This prospective pilot study will investigate whether use of a pulsed dye laser (PDL) prior~     to surgical excision can improve the appearance and symptoms of scars. The primary outcome~     measurement for the study is the quality of the scar in areas pre-treated with PDL vs.~     control (cryogen spray only). For this study, subjects who are scheduled for a dermatologic~     surgical excision will have half of the surgical area pre-treated with PDL and the other half~     pre-treated with cryogen spray.~   "
84655|NCT02458963|"~     The purpose of this study is to compare the efficacy of in vitro fertilization (IVF) versus~     gonadotropin therapy in infertile women having clomiphene citrate (CC) resistant polycystic~     ovarian syndrome (PCOS).~   "
84656|NCT02458950|"~     This study is aimed to determine clinical characteristics of patients with anorexia nervosa~     and outcome of treatment at Sirirraj Hospital.~   "
84721|NCT02458092|"~     The purpose of this study is to determine whether an investigational malaria vaccine is safe~     and induces an immune response against malaria when tested in adults living in the United~     States.~   "
84781|NCT02457299|"~     This multi-center, randomized prospective clinical trial involves esophageal cancer patients~     who are surgical candidates. Patients will be randomized either to the one stage or the two~     stage esophagectomy procedure. Surgical, oncology outcomes, quality of life and cost analysis~     from both types of procedure will be reviewed and compared.~   "
84657|NCT02458937|"~     Although uncommon in the general pediatric population, osteonecrosis (ON) is prevalent in~     children and adolescents with cancer, particularly among those that have had chronic exposure~     to glucocorticoids and among those having undergone allogeneic hematopoietic stem cell~     transplantation. Patients with hematologic disease are also at risk for developing ON.~      Hip Core Decompression (HCD) is a widely used surgical procedure with several studies~     reporting positive results; however, most are subject to criticism because of the limited~     sample size or the absence of appropriate functional outcome measures.~      The objective of this pilot study is to observe and collect information on several functional~     outcome measures and assess if Hip Core Decompression (HCD) potentially improves functional~     outcomes in children, adolescents and young adults with osteonecrosis.~      PRIMARY OBJECTIVE:~        -  To describe functional outcomes of children, adolescents, and young adults with~          osteonecrosis of the femoral head following hip core decompression surgery. Parameters~          assessed will include pain, functional mobility, endurance, quality of life, and gait~          patterns pre-operatively and post-operatively over time.~   "
84658|NCT02458924|"~     Patients with schizophrenia have abnormal skin flush response to niacin, but the niacin skin~     test accuracy is not well studied in these patients. The study evaluated the niacin skin test~     accuracy in adult hospitalized schizophrenia patients and their first degree relatives,~     bipolar disorder patients, and healthy controls.~   "
84659|NCT02458911|"~     The purpose of the study is to obtain data regarding safety and efficacy of drug-eluting~     balloon luminor 14 & luminor 35 in the treatment of infrainguinal occlusive lesions~     (superficial femoral artery (SFA), popliteal artery (PA) and tibial arteries (ATs)) and~     restenosis from prior endovascular procedures in this sector.~   "
84660|NCT02458898|"~     This is a prospective randomized controlled trial investigating the impact of educational~     bidirectional text message reminders on gluten free diet adherence among adolescents and~     young adults with celiac disease age 12-24. Participants will complete a series of online~     questionnaires assessing quality of life, patient activation, celiac symptoms, and self~     reported dietary adherence at the beginning and end of the study. Participants will also have~     their blood drawn to measure Tissue Transglutaminase IgA (TTG IgA) antibody and Deamidated~     Gliadin Peptide IgA (DGP IgA) at the beginning and end of the study. Lab draws can be done~     locally, and are at no cost to the participant. Patients are randomized to the intervention~     or control group based on enrollment TTG IgA. Intervention group receives 45 unique text~     messages over the 3 month study. A gift card is provided for participation in the study.~   "
84661|NCT02458885|"~     Aim of investigators is to conduct a registry of acute myocardial infarction including a~     broad network of critical care / coronary care unit throughout Argentina to increase the~     knowledge about treatments, timing of reperfusion therapy and outcomes, both in-hospital and~     during short-term follow up.~   "
84662|NCT02458872|"~     This is a pragmatic, paired, cluster-randomized controlled trial evaluating the impact of a~     safety huddle-based intervention on physiologic monitor alarm rates on pediatric inpatient~     units.~   "
84663|NCT02458859|"~     Randomised Controlled Trial of PICO (a portable Negative Pressure Wound Therapy) versus~     standard care in patients with chronic and sub-acute wounds. Sample size 100 patients to~     investigate Time to healing, health economic and patient reported outcomes.~   "
84664|NCT02458846|"~     Amblyopia (lazy eye), is the leading treatable cause of vision loss in childhood. Uncorrected~     refractive errors (ie farsightedness) can lead to difficulties in school. Unfortunately, many~     children do not receive vision screening until they have already developed irreversible~     vision problems. This has led to the development of a variety of screening protocols and~     devices that attempt to identify patients at risk for vision problems early in life. This~     study aims to compare the leading vision screening devices/protocols to a new device, The~     Pediatric Vision Scanner, and compare their ability to detect vision problems against a gold~     standard eye exam.~   "
84665|NCT02458833|"~     This study aims to test the effectiveness of a community-based, peer-mentored intervention to~     improve home food preparation practices in families with young children.~   "
84666|NCT02458820|"~     Non-convulsive seizures (NCS) following cardiac arrest are common and are associated with~     worse neurologic outcomes and increased mortality. More prolonged seizures (status~     epilepticus) are associated with worse outcomes. Earlier diagnosis and treatment of seizures~     may lead to earlier termination of seizures and decreased seizure burden.~      This study will evaluate whether bedside intensive care unit (ICU) provider interpretation of~     a type of EEG called DSA EEG can be used by non-neurologists to diagnosis seizures more~     rapidly than continuous EEG's routinely read by neurologists.~   "
84667|NCT02458807|"~     The World Health Organisation predicts that lung disease will be the World's third largest~     killer in the future. This research project is looking to see whether the concept of a home~     hospital using the latest gadgets and iPad technology, can help patients stay well and out~     of hospital.~      Portsmouth Hospitals Trust is collaborating with a Company based in the United Kingdom (UK)~     who has developed a test to predict when people with lung diseases, such as; asthma, COPD and~     bronchiectasis, who regularly have chest infections, are about to become poorly with another~     infection - a form of early warning system. The investigators hope that the test will~     eventually be able to be used by the patient at home daily, to help self-manage their~     condition. The test measures whether bacteria are present, in sputum, and in what quantity.~     This information can be used by the patient's healthcare team to consider providing treatment~     earlier, thus controlling the infection sooner and reducing the patient's symptoms so that~     patients can stay at home rather than being regularly admitted to hospital.~      Part of this early warning system that has been developed by the UK Company includes the~     daily measurement of a number of indicators of health. These are usually only measured in~     hospital or by a General Practitioner, but new devices have been made that are simple enough~     for everyone to use at home.~      The investigators will include 30 participants, with non-Cystic Fibrosis (CF) chronic~     respiratory conditions who will be asked to take daily measurements of their blood pressure,~     temperature, weight and how well their heart and lungs are working with easy-to-use devices.~     They will also measure their physically activity with an activity tracker and report their~     wellness and whether they have taken medication daily. Participants will also be asked to~     collect a sample of sputum and urine each morning. Taking the samples and measurements should~     only take between 5-15 minutes each day to carry out.~      The sputum and urine will be tested at the hospital and will be recorded and analysed, so~     that the researchers can learn what happens well before a person with these conditions falls~     sick and needs hospitalisation.~   "
84668|NCT02458794|"~     The Ambu-Aura GainTM is a new extraglottic airway device which brings together features of~     both the LMA ProSealTM (high seal cuff, gastric access and bite block - to facilitate~     ventilation, airway protection and airway obstruction, respectively) and the LMA UniqueTM~     (single use - prevention of disease transmission). In the following randomized, crossover~     study, the investigators test the hypothesis that ease of insertion, oropharyngeal leak~     pressure, fiberoptic position and ease of gastric tube placement differ between the Ambu-Aura~     GainTM and the LMA SupremeTM in paralyzed, anesthetized patients.~   "
84671|NCT02458755|"~     Purpose: Intracranial atherosclerosis is a common condition in Korean population consisting~     over 25% of ischemic stroke etiology. American Stroke Association and Korean Stroke Society~     recommend antiplatelet and statin for the treatment of intracranial atherosclerosis. Besides~     lowering blood cholesterol levels statin also stabilize atherosclerotic plaque and eventually~     lower the risk of ischemic stroke. However, little evidence resides on the effect of statin~     treatment on intracranial atherosclerosis. Recent advance in high-tesla magnetic resonance~     imaging enables direct imaging of intracranial atherosclerotic plaque and further assessment~     of treatment efficacy of statin in stabilization of intracranial atherosclerotic plaque~     became possible.~   "
84672|NCT02458742|"~     Pain after transurethral resection of prostate is considered mild to moderate severity from~     detrusor muscle spasm and traction from urinary catheter. Numerous pain relieve methods have~     been studied including spinal opioids, spinal anesthesia with local anesthetic and~     dexmedetomidine, periprostatic nerve blockade with bupivacaine and mixing of prilocaine with~     distilled water irrigation while undergoing a procedure. Most of patients having this~     procedure are in elderly period, thus many anesthetists avoided spinal morphine which may~     cause respiratory depressant effect postoperatively. Although previous studies showed~     effectiveness of spinal morphine 25-200 mcg, some patients suffered from neuraxial opioid~     side effects.~      The aim of this study is to demonstrate efficacy of local anesthetic with intrathecal~     morphine 50 mcg providing pain relieve after transurethral resection of prostate compare to~     spinal anesthesia with sole local anesthetic.~   "
84673|NCT02458729|"~     The aim of this study was to conduct a prospective, randomized, double-blind study and assess~     the efficacy of and safety for thromboprophylaxis of rivaroxaban in total knee arthroplasty~     patients when tranexamic acid is used for bleeding prophylaxis.~   "
84674|NCT02458716|"~     This phase I trial studies the side effects of cytoreductive prostatectomy in treating~     patients with newly diagnosed prostate cancer that has spread from the primary site to other~     places in the body. Cytoreductive prostatectomy is a type of surgery that removes the~     prostate and as much of the tumor as possible. When combined with hormone therapy, robotic~     assisted radical prostatectomy (RARP) or conventional open retropubic radical prostatectomy~     (RRP) may prolong survival in patients with prostate cancer that has spread.~   "
84675|NCT02458703|"~     Pulmonary arteriovenous malformations (PAVMs) are a rare vascular condition affecting the~     lungs. PAVMs lead to low blood oxygen levels, yet are very well tolerated by patients. This~     study will examine the exercise capacity of PAVM patients using formal cardiopulmonary~     exercise tests performed on a stationary bicycle, and whether this is affected by the~     presence of concurrent airflow obstruction, such as due to asthma.~   "
84676|NCT02458690|"~     The objective of this randomized controlled trial is to evaluate whether the investigators~     modernized IMPACT intervention for depression (eIMPACT), delivered before the onset of~     cardiovascular disease (CVD), reduces the risk of future CVD. Participants will be primary~     care patients who are depressed but do not have a history of CVD. Half of the participants~     will receive standard depression treatment in primary care (usual care), and the other half~     will receive one year of eIMPACT, a collaborative stepped care program including~     antidepressants and computerized and telephonic cognitive-behavioral therapy. To evaluate~     change in CVD risk, the investigators will measure artery function using ultrasound before~     and after the 1-year treatment period. It is hypothesized that patients who receive the~     eIMPACT intervention will have greater improvements in artery function than patients who~     receive usual care.~   "
84677|NCT02458677|"~     This single ascending dose study is to determine safety, tolerability, pharmacokinetics and~     immunogenicity of PRX003 in approximately 40 healthy subjects.~   "
84678|NCT02458664|"~     We collect prospectively and retrospectively, patients' demographic, pathological, surgical,~     therapeutic and prognosis informations in a database. After patient's consent to collect~     tumoural samples of their colorectal cancer after resection.~      We will then be able to evaluate the impact of HSP110, a chaperon protein, on their~     prognosis. Other proteins (to be determined) will also be study, after.~   "
84679|NCT02458651|"~     The purpose of this observational study is to describe patient and disease characteristics as~     well as treatment patterns in Chinese patients with unresectable stage IIIB or IV non-small~     cell lung cancer (NSCLC). In addition, this study characterizes the clinical outcomes for~     various populations of patients defined by clinical and tumor characteristics, treatment~     patterns, and hospital category defined by city tier and geographic region.~   "
84680|NCT02458638|"~     The primary efficacy objective for this study is to evaluate non-progression rate (NPR) at 18~     weeks in participants with advanced solid tumors treated with atezolizumab, defined as the~     percentage of participants with complete response (CR), partial response (PR), or stable~     disease (SD) as assessed by the investigator according to Response Evaluation Criteria in~     Solid Tumors (RECIST) Version (v) 1.1, or according to disease-specific criteria for prostate~     cancer and malignant pleural mesothelioma.~   "
84681|NCT02458625|"~     This study is aimed to compare the efficacy of two mode of iron administration to treat post~     partum anemia - a single dose of intravenous iron sucrose versus a single dose of iron~     sucrose and 6 weeks of treatment with oral iron supplement.~   "
84682|NCT02458612|"~     The purpose of this study is to investigate the effects of mirror therapy combined with upper~     extremity strengthening training on upper extremity function in children with unilateral~     spastic Cerebral Palsy (CP): a single blind randomized controlled trial. In the literature,~     there was no randomized controlled trial. According to literature, there are few studies that~     investigate the effects of mirror therapy in children with CP. But there is no randomized~     controlled trial, explore the effects of mirror therapy combined with upper extremity~     strength training on upper extremity functions in unilateral spastic CP. Hypothesis of this~     study is that mirror therapy combined with strength training improves upper extremity~     function and muscle strength in unilateral spastic CP.~   "
84683|NCT02458599|"~     This study is designed to investigate whether protein supplementation can improve recovery of~     muscle function following a strenuous combination of both endurance and resistance exercise.~     It will specifically investigate the effect of protein supplementation on the recovery of~     strength, power and endurance exercise performance, along with measures of damage and~     inflammation of the muscle.~   "
84684|NCT02458586|"~     Epidemiological data and studies in animal models suggest, that polyunsatured fatty acids~     (PUFA) rather than mono-unsatured fatty acids (MUFA) are associated with lower hepatic lipid~     content (HCL) and may facilitate a decrease of HCL in case of non-alcoholic fatty liver~     disease (NAFLD).~      The investigators therefore conduct an interventional trial in subjects with normal glucose~     metabolism, but increased HCL, fulfilling criteria for NAFLD.~      The study will compare two dietary interventions in parallel design, one containing mainly~     PUFA (canola oil), one containing only MUFA (olive oil). The intervention of 8 weeks is~     accomodated by dietary counseling. Metabolic outcome variables will be assessed with MR~     spectroscopy (liver fat) and euglycemic hepatic clamp (glucose metabolism/insulin~     sensitivity).~   "
84685|NCT02458573|"~     The investigators hypothesized that sympatholytic effect of epidural analgesia would~     attenuate the hemodynamic instability and decrease in the splanchnic blood flow caused by~     pneumoperitoneum during laparoscopic surgery. This study is to compare the effect of epidural~     analgesia and intravenous analgesia on postoperative bowel movement in patients undergoing~     laparoscopic gastrectomy.~   "
84686|NCT02458560|"~     The purpose of this study is to assess the safety and device success of the Edwards CENTERA~     Transcatheter Heart Valve (THV) System in symptomatic adult patients with severe aortic~     stenosis.~   "
84687|NCT02458547|"~     Despite many previous studies, whether anesthetic technique will significantly affect overall~     patient outcome, morbidity and mortality in elderly hip fracture patients is controversial.~     Due to old age, poor patient condition and emergent clinical settings, patients undergoing~     surgical procedures for hip fracture management are often subject to poor postoperative~     outcome and high mortality rates. While many studies have reported that regional anesthesia~     leads to improved postoperative outcome after hip fracture surgery, others have concluded~     otherwise. Moreover, because the majority of these previous studies are retrospective cohorts~     or systemic reviews, there is a need for randomized clinical trials to provide high quality~     evidence. This study aims to compare patient outcome between three different anesthetic~     techniques in elderly patients undergoing surgery for hip fracture management by evaluating~     proinflammatory cytokines, chemistry lab testing and clinical outcome between general~     anesthesia with either desflurane or propofol-based TIVA and spinal anesthesia with~     bupivacaine.~   "
84688|NCT02458534|"~     The purpose of this study is to evaluate whether the McGrath MAC videolaryngoscope is~     superior when compared to the C-MAC videolaryngoscope and the Macintosh laryngoscope for~     novice users in manikin.~   "
84689|NCT02458521|"~     The overall objective of this project is to determine the efficacy and tolerability of TMS~     for mild Traumatic Brain Injury (mTBI) with PTSD symptoms and correlate treatment response~     with anatomical and biological factors unique to each service member (SM). Exploratory work~     will be done to look at the neuronal and biological changes that may occur over the course of~     TMS treatment.~   "
84690|NCT02458508|"~     Glioblastoma (GBM) accounts for approximately 50% of all glioma and among these tumors, are~     the most malignant. The cells of origin of glioma are still undefined, but the most putative~     target cells include astrocytes, neural stem cells, and oligodendrocyte precursor cells. The~     current standard of care for patients with newly diagnosed GBM includes temozolomide and~     radiotherapy . Melanocortins are peptides with well-recognized anti-inflammatory and~     neuroprotective activity. Of the five known melanocortin receptors (MCRs), only subtype 4 is~     present in astrocytes and it is expressed predominantly in the brain. No data are currently~     available on MC4R gene polymorphisms and gliomas or their relationship with radiotherapy or~     chemotherapy.~      Aim. Given the association of MC4R with antiinflammatory activity, neuroprotection, induction~     of neural stem/progenitor cell proliferation in brain hypoxia, and prevention of astrocyte~     apoptosis, the aim of this study is to retrospectively evaluate the possible~     prognostic/predictive role of the MC4R SNPs on GBM therapy.~   "
84691|NCT02458495|"~     A significant percentage of persons with diabetes fail to properly take their prescribed oral~     hypoglycemic agents (OHA) and insulin. Non-adherence to medications among diabetes patients~     is associated with poor health outcomes including suboptimal glycemic control,~     diabetes-related complications, elevated health costs and increased risk of hospitalization~     and mortality. Given the substantial impact of non-compliance on the health of patients,~     prior studies have sought to draw links between medication adherence and patient factors.~      Research shows that web-based interventions that support patients' medication-related~     knowledge, motivation and skills effectively improve compliance.~      The purpose of this study is to evaluate the impact of a patient web portal (PWP)-delivered~     medication adherence promotion intervention on medication adherence and glycemic control~     among patients with type 2 diabetes (T2DM). The intervention aims to (1) increase~     self-reported adherence to glucose lowering agents (GLAs) and (2) improve diabetes health~     outcomes (decreased HbA1c) by increasing patients' medication adherence-related knowledge,~     motivation and skills.~      This research will greatly enhance the investigators' understanding of medicine compliance~     and the factors that effectively improve adherence among high-risk patients with diabetes.~     Knowledge gained from this work may inform future internet-based patient portals that support~     disease management and medication adherence more broadly.~   "
84692|NCT02458482|"~     The objective of this randomized control trial is to investigate the efficacy of an adjunct~     positive airway pressure (PAP) nebulizer device known as AccuPAP in the treatment of~     moderate-severity acute asthma exacerbations in children ages 6 - 17 years in comparison with~     an institutional standard continuous dual-therapy nebulizer treatment.~      The investigators main goal, more specifically, is to determine if the additional positive~     airway pressure provided by the AccuPAP device when used in treating children with~     moderate-severity asthma exacerbations provides a more optimal delivery of bronchodilator~     therapy when compared to institutional standard protocol nebulizer delivery mask which does~     not employ the use of positive airway pressure in medication delivery. The investigators have~     determined that the change in a study-validated Acute Asthma Intensity Research Score (AAIRS)~     which will be considered statistically significant for a patient is 2 points or greater after~     the first treatment has been completed.~   "
84782|NCT02457286|"~     Metformin is being compared to exercise and diet modifications. The researchers are~     interested in learning if the addition of metformin to lifestyle modifications is more~     helpful in treating the condition or disorder. Although metformin is FDA approved to treat~     type 2 diabetes, it is not FDA approved for the treatment of Non-alcoholic fatty liver~     (NAFLD) and is considered investigational for the purpose of this study.~   "
84693|NCT02458469|"~     The purpose of this study is to look at the effect of exciting using drugs to target a~     specific pathway in the body, that relies on a natural chemical the body produces called~     'serotonin', in patients with spinal cord injury (SCI) during sleep. During this part of the~     study participants will be asked to take buspirone (Buspar) (15-50mg per day), trazodone~     (100mg per day) and a placebo in a random fashion, each for a 2 week period (drug period) of~     time followed by two weeks without drugs (washout period). The drugs will not be taken all at~     the same time, but each will be taken separately for two weeks followed by a night study to~     look at the effect the medication/placebo pill has on the way the body responds during sleep.~   "
84694|NCT02458456|"~     The aim of this project is to conduct a randomised controlled trial to assess the effect of~     performing isometric exercise using a handgrip dynamometer on blood pressure.~   "
84695|NCT02458443|"~     Recent meta-analyses suggest isometric resistance training (IRT) may be superior to aerobic~     exercise for lowering blood pressure. The investigators intend to conduct the largest,~     longest, prospective, double-blind randomized controlled trial using isometric resistance~     training to reduce blood pressure to reduce hypertension.~   "
84696|NCT02458430|"~     Balance and gait problems cause severe impairments for people with Parkinson's disease In~     some Parkinson's disease patients the investigators see a loss of acetylcholine in the brain.~     In previous studies the investigators have shown that this loss of acetylcholine is related~     to impaired balance and gait function in Parkinson's disease. In this study the investigators~     will take a closer look at this finding.~   "
84697|NCT02458417|"~     The purpose of this study is to assess the efficacy and safety of ReCell grafting after CO2~     laser abrasion with superficial full surface ablation, fractional laser treatment and~     conventional (deep) full surface CO2 laser ablation, to assess the practical aspects and the~     patient reported outcome and to assess the cellular composition of the graft.~   "
84698|NCT02458404|"~     This study will help determine the effect of varied estradiol levels on the uterine lining in~     healthy humans that are not undergoing a stimulated in vitro fertilization (IVF) cycle.~   "
84699|NCT02458391|"~     The purpose of this study is to investigate which number of lymphedema therapy~     treatments/week best reduces upper extremity swelling, increased arm function, and reduces~     the most lymphedema symptoms.~   "
84700|NCT02458365|"~     Male-to-female intimate partner violence accounts for 26% of violence-related injuries in~     women presenting in hospital emergency departments and 33% of all female homicides.~     Adolescence provides an excellent window of opportunity for the prevention of intimate~     partner violence. Patterns of relating in intimate relationships are still relatively~     undifferentiated and open to influence. However, the evidence supporting traditional,~     school-based programs for the prevention of teen dating violence is mixed. A major problem~     with existing programs is that they are one size fits all, making it difficult to meet the~     diverse needs of students—boys and girls, individuals who are dating and those who are not,~     individuals who have experienced dating violence as a victim, perpetrator, or both, and those~     who have not. Perhaps most importantly, these interventions neglect individual differences in~     readiness to use healthy, non-violent ways of relating to stay violence-free. In Phase I the~     objective was to use expert system technology to integrate best practices for teen dating~     violence prevention with the Transtheoretical Model of Behavior Change (TTM), the stage~     model, to develop an interactive, multimedia computer-administered change program that~     delivers individualized intervention sessions and exercises tailored to stage of change and~     other individual characteristics. In Phase II, the objective was to complete development of~     the intervention package and assess its efficacy in a randomized clinical trial involving~     3,901 teens from 20 Rhode Island high schools randomly assigned to intervention or~     comparison. Among youth exposed to risk for dating violence, efficacy was assessed by~     comparing the intervention and comparison groups on dating violence perpetration and~     victimization at follow-up. Among youth not exposed to risk for dating violence, efficacy was~     assessed by comparing intervention and comparison on peer violence perpetration and~     victimization.~   "
84701|NCT02458352|"~     The aim of the study is to compare the CACS obtained from standard dose CT to the CACS~     obtained from ultra-low-dose scans. Additionally, the usefulness of ultra-low-dose CT for AC~     of myocardial perfusion SPECT will be assessed.~   "
84702|NCT02458339|"~     The goal of this clinical research study is to establish the maximum tolerated dose (MTD) of~     direct administration of methotrexate into the fourth ventricle of the brain in patients with~     recurrent malignant brain tumors including medulloblastoma, primitive neuroectodermal tumors~     (PNET), atypical teratoid/rhabdoid tumors (AT/RT), and ependymoma.~      Methotrexate is designed to block cancer cells from dividing, which may slow or stop their~     growth and spread throughout the body. This may cause the cancer cells to die.~   "
84703|NCT02458326|"~     Fibromyalgia and migraine are diseases with high prevalence in women between the age group of~     30-60 years, which seem to share the same pathophysiological mechanism; both originate from~     neuroendocrine disorders of the hypothalamic-pituitary axis in the central nervous system,~     and are therefore closely related. In addition to the strong relationship with migraine,~     fibromyalgia can also be associated with sleep disorders, chronic fatigue and psychological~     disorders. The combination of these factors decreases the quality of life and contributes to~     increased sedentary this population. It is known that physical exercise promotes positive~     changes in pain pathophysiological pathway to increase the release of endorphins~     neuroendógenas, improving the symptoms of fibromyalgia.~      The objective of this study is to analyze whether the application of an aerobic exercise~     program may result in the reduction of the frequency, duration and intensity of migraine~     attacks in women with fibromyalgia. For this, a clinical trial will be conducted randomized~     double-blind clinical trial comparing two groups of women diagnosed with fibromyalgia and~     migraine. Initially, all answer questionnaires assessing quality of life, impact of headache,~     level of depression and anxiety, sleep quality, physical activity level, and; will be held~     ergospirometry for research in exercise tolerance. The experimental group will implement the~     protocol consists of heating, aerobic exercise according to the heart rate established for~     training by spirometry and slowdown; and the control group will hold the heat on low speed~     and heart rate will next baseline. Both groups will be followed for 12 weeks, with a~     frequency of three weekly meetings lasting 30 minutes and re-evaluated every 4 weeks. At the~     end of the protocol, the groups will have their results were compared and statistically~     analyzed.~   "
84704|NCT02458313|"~     Obesity is a serious and growing health problem in the United States. Obesity is associated~     with health problems such as type-2 diabetes and cardiovascular disease, leading to decreased~     quality of life and increased mortality. Given the health and quality-of-life effects of~     obesity, developing effective treatments clearly is an important goal.~      This study plans to learn more about the effects of an investigational new drug (DMXB-A~     (3-(2,4-dimethoxybenzylidene anabaseine)) and its effects on obesity. The study drug has~     similar effects to nicotine. Since nicotine has been found to affect appetite, the~     investigators are interested in studying effects of the study drug, which has some~     similarities to nicotine, on how your brain responds to such things as pictures of food. The~     study drug has not been approved by the Food and Drug Administration (FDA), and is considered~     experimental.~   "
84705|NCT02458300|"~     The objective of this study is to evaluate the clinical response of children diagnosed with~     acute bronchiolitis, relative to a chest physiotherapy protocol. Comparing this treatment~     with standard care of the nursing staff and auxiliaries of infants patients aged 1 month to 2~     years.~   "
84707|NCT02458274|"~     The main long-term complication of lung transplantation is chronic lung allograft dysfunction~     (CLAD). Bronchiolitis obliterans syndrome (BOS) is the most frequent presentation of CLAD.~     BOS leads to a progressive loss of lung allograft function, with recurrence of dyspnea and~     airflow limitation. In some advanced cases, patients need a lung re transplantation. The~     mechanisms of BOS are not completely elucidated, and there are no early markers or specific~     treatment available for this condition.~      Microparticles (MPs) are submicron plasma membrane fragments released into the vascular~     compartment or the pericellular space in response to cell activation, injury or apoptosis.~     Broncho alveolar and circulating MPs may reflect cellular insults of the lung allografts.~     Therefore, MPs could be viewed either as biomarkers or as effectors of the chronic~     inflammatory or procoagulant processes leading to bronchiolitis obliterans syndrome.~      The investigators plan to include 60 patients before lung transplantation at our centre in~     Strasbourg (France). Follow-up will be requested at the base of usual care (spirometry, blood~     sampling, bronchoscopy with broncho-alveolar lavage [BAL]). The investigators will measure at~     one month, one, two and three year post transplantation, the total concentration of MPs in~     plasma and BAL and characterize their phenotype.~      The investigators objective is to demonstrate correlation between total MPs concentration in~     broncho-alveolar lavage fluid (BALF) and the occurrence of bronchiolitis obliterans syndrome~     at three years post lung transplantation.~   "
84708|NCT02458261|"~     This prospective, multi-center study aims to determine the pharmacokinetics and~     pharmacodynamics of extended-infusion cefepime in continuous renal replacement therapy~     (CRRT).~   "
84709|NCT02458248|"~     Chronic kidney disease, which affects an estimated 300,000 people in Ireland and over 50~     million people in the developed world, is responsible for a considerable burden of premature~     mortality and morbidity. All patients with chronic kidney disease are recommended low salt~     diets, i.e. less than a teaspoon of salt per day (which is <5-6g of salt, which contains~     <2-2.3g of sodium). The average intake in the general population is double the recommended~     intake, between 1-2 teaspoons per day, which is considered 'moderate' intake. In patients~     with hypertension, reducing from moderate (average) to low intake is associated with a small~     reduction in blood pressure. However, achieving this low target salt intake is difficult, and~     can have a negative knock-on effect on other healthy dietary factors and kidney hormones. In~     addition, there is no convincing research to show that patients with chronic kidney disease~     and normal blood pressure benefit from low salt intake. In fact, the small amount of research~     that does exist shows that the change in kidney function is the same in people who consume~     low salt diets (<1 teaspoon) and moderate (1-2 teaspoons=average intake) salt diets.~     Moreover, there are some small studies that report that low-salt diets may increase the risk~     of death due to heart disease. Given that all patients with chronic kidney impairment are~     recommended a low-salt diet, it is important that we confirm that this recommendation truly~     benefits patients. In this randomized controlled trial, we hope to determine whether~     recommending a low salt intake, compared to average/moderate intake, is associated with a~     slower rate of decline in kidney function in patients with chronic kidney impairment. The~     results of this study will provide information to guide future research that will have~     critical implications for management of patients with chronic kidney disease.~   "
84710|NCT02458235|"~     The goal of this study is to determine whether post-transplant consolidation with azacitidine~     combined with donor lymphocyte infusion (DLI) is a safe and effective approach for the~     prevention of relapse in pediatric and young adult patients with hematologic malignancies who~     have undergone hematopoietic stem cell transplantation (HSCT).~   "
84711|NCT02458222|"~     Aphasia is a language impairment experienced by about one third of stroke patients. This~     often devastating condition is treated by speech and language therapists (SLTs). There is~     evidence that language games delivered at the right intensity are an efficacious means of~     improving communication for people with post stroke aphasia. However, it is unclear which~     mechanism of language facilitation used in a game works best. This study will provide~     evidence for the active ingredient of a game, together with measures of efficacy,~     feasibility and enjoyment compared to standard aphasia therapy.~   "
84712|NCT02458209|"~     This is an open label, single dose, randomized, parallel group study in healthy adult~     subjects to assess the comparability of bococizumab administered in a prefilled syringe vs.~     prefilled pen and comparability between drug substance manufactured at Pfizer Andover vs.~     Boehringer Ingelheim Pharma.~   "
84713|NCT02458196|"~     This is an open-label randomized controlled trial to compare the efficacy of Prednisone alone~     and combination therapy of Prednisone and Mycophenolate mofetil in IgG4RD patients.~   "
84714|NCT02458183|"~     The objective of this study is to assess the immunogenicity and safety of the DTaP-IPV~     combination vaccine compared with those of separate DTaP and IPV vaccines administered to~     healthy infants at 2, 4, and 6 months of age.~   "
84715|NCT02458170|"~     The purpose of the project is to examine what kind of molecular mechanism which causes~     inflammatory joint diseases. This examination is carried out by a collection and analysis of~     synovial tissues for patients without inflammatory joint diseases compared to the experienced~     equivalent biopsies from patients with inflammatory joint diseases.~   "
84716|NCT02458157|"~     The objective of this pilot trial is to assess the feasibility of forced fluid removal in~     patients admitted to the intensive care unit (ICU) with high-risk AKI and severe fluid~     overload. The intervention will use furosemide infusion and/or continuous renal replacement~     therapy (CRRT) to achieve and maintain a neutral cumulative fluid balance. The intervention~     will be compared to standard of care as reflected in the kidney disease improving global~     outcome (KDIGO) guidelines.~   "
84717|NCT02458144|"~     Aim of the present investigation is to analyse the amount of muscle trauma in relation to the~     surgical approach and to the individual postoperative functional recovery. The investigation~     will compare the MIS (minimally invasive surgery) anterior approach with the MIS~     anterolateral approach to the hip.~   "
84718|NCT02458131|"~     The number of youth with type 2 diabetes is predicted to quadruple by 2050, with a~     disproportionate increase among minority youth. The research proposed in this Career~     Development Award will use community-based participatory research methodology as well as~     novel strategies (peer education and mobile health technologies) to design, implement and~     evaluate a diabetes prevention intervention for at-risk ethnic minority youth in an urban~     community with high disease burden.~   "
84719|NCT02458118|"~     The purpose of this study is to assess pancreatic perfusion in patients with chronic~     pancreatitis at rest and after secretin stimulation and compare this to published data on~     pancreatic perfusion in normal subjects.~   "
84720|NCT02458105|"~     The overarching aim of the research project is to investigate whether Acceptance & Commitment~     Therapy (ACT) is an efficacious psychotherapeutic method of treatment for inpatients~     suffering from acute psychosis.~      The method will be applied in two ways. Firstly, as an individual treatment for patients.~     Secondly, as an integrated part of the daily work on an inpatient ward, administered by~     nurses and assistant nurses trained in the method.~   "
84722|NCT02458079|"~     Treatment for severe alcoholic hepatitis patients not eligible for steroid therapy is a~     dilemma. Pentoxyfilline has been shown to have no improvement in outcomes as per current~     studies and liver transplantation is with great risk of recidivism in this difficult to treat~     cohort of patients. Dysbiosis forms the central role in severe alcoholic hepatitis patients~     and modulation of gut microbiota by way of healthy donor fecal transplantation could prove to~     be a novel way to treating these patients who are ineligible for standard therapy. This study~     utilizes correction of dysbiosis in severe alcoholic hepatitis and surveys outcomes with the~     same with respect to survival and liver disease severity scores.~   "
84723|NCT02458066|"~     Twenty-four (24) clusters, each containing between 250-300 houses were selected throughout~     Bioko Island to be sprayed with either a long lasting pyrethroid insecticide, K-Othrine SC~     62.5, or a bendiocarb insecticide, FICAM. Parasite prevalence in children aged 2-14 was~     measured before and after the application of insecticide.~   "
84724|NCT02458053|"~     The purpose of this study is to determine the effect of a spousal support enhanced weight~     loss program on weight loss among African American men.~   "
84725|NCT02458040|"~     This study is a meta-epidemiological study which aim is to quantify the clinical benefit of~     the biomarker-based strategy compared to conventional strategy across all drugs with such a~     strategy.~   "
84726|NCT02458027|"~     The objectives of this trial are to investigate whether the effects of hemp protein on~     glycemic and appetite control are insulin-dependent by measuring 1) blood glucose, insulin~     and appetite for one hour following consumption, 2) blood glucose, insulin and appetite~     following a fixed energy meal to determine the second meal effect of hemp protein versus~     soybean protein and a non-protein control.~   "
84727|NCT02458014|"~     The goal of this clinical research study is to learn if Blinacyto (blinatumomab) can help to~     control ALL with positive MRD. The safety of this drug will also be studied.~      This is an investigational study. Blinatumomab is FDA approved and commercially available for~     the treatment of ALL. It is considered investigational to use blinatumomab to treat ALL~     patients with MRD. The study doctor can explain how the study drug is designed to work.~      Up to 40 participants will be enrolled in this study. All will take part at MD Anderson.~   "
84728|NCT02458001|"~     Women affected by gynaecologic cancers are often not aware of sexual consequences of cancer~     and its treatment. Most do not receive appropriate advice or help to recover sexual function,~     and the impact on their sexuality may be profound. Despite this several potential therapies~     can be effective in helping recovery. A major challenge is informing and involving the~     patients in an appropriate and sensitive manner, and a further issue is the delivery of such~     therapies in busy and medically driven gynaecologic oncology clinics. It will use and adapt~     existing evidence based therapies for improving sexual function after cancer treatment and~     develop a model for delivering these in the NHS (United Kingdom National Health Service)~     setting. The model of 'stepped care' is adapted from that used nationally and successfully in~     the Increasing Access to Psychological Therapies (IAPT) programme. Assessment allows for~     'stepping up and down', i.e. calibrating the type of help a woman receives according to need~     and her response to treatment already given.This study will develop and evaluate a 'stepped'~     system of interventions using elements of best available evidence, adapting existing~     interventions to help women recover their sexual feelings and activity, starting with simple~     methods, moving on to new talking treatments for more complex cases. The investigators~     address all gynaecologic cancers on the principle that sexual difficulty is the problem the~     investigators are treating, not the cancer of origin. Ongoing clinical assessment will be~     vital for the success of the stepped care model. The investigators will deliver training and~     supervision to enhance the skills needed by the Clinical Nursing Specialist (CNS). An~     important part of this study will be characterising the range of women and their willingness~     to participate in psychosexual help. One-to-one follow up interviews will inform the level of~     input required for any subsequent Randomised Control Trial (RCT). The investigators will use~     internationally recognised rating scales for rating sexual function, assess how illness and~     treatment affect mood and self esteem. The investigators will also measure the overall~     cost-effectiveness to the public sector of providing this treatment, compared to costs of~     subsequent use of health and social services. This pilot study will assess the feasibility of~     conducting a full scale investigation of a stepped therapy and indicate the potential~     benefits to the patients, their partners, and to the NHS generally.~   "
84729|NCT02457988|"~     A prospective series comparing care incorporating home monitoring and liver care coordination~     to conventional care for patients with cirrhosis.~   "
84730|NCT02457962|"~     To collect and analyze specimens that will correlate with clinical outcomes such as acute and~     late toxicities, quality of life, local control, and survival of patients treated with~     photon/proton therapy.~   "
84731|NCT02457949|"~     This study evaluates whether altering the timing and frequency of social assistance~     disbursement reduces drug related-harms that increase on the days surrounding monthly~     synchronized government social assistance cheque issue.~   "
84732|NCT02457936|"~     Depression one of the leading causes of disability worldwide. Individuals suffering from~     depression typically exhibit impairments in various mental abilities, such as the ability to~     effectively direct and control attention and the ability to switch between thinking about~     different things and concepts (commonly referred to as cognitive flexibility).~      Mindfulness meditation training is a technique which involves focusing one's awareness on the~     present moment, while calmly acknowledging and accepting one's feelings, thoughts, and bodily~     sensations. It has been well documented to improve depressive symptoms and prevent recurrence~     of depressive episodes, yet little is known about how mindfulness does so and what are the~     underlying mental mechanisms involved. Here the investigators propose to examine the efficacy~     of an 8-week mindfulness training program in improving the ability to direct and control~     attention, as well as in cognitive flexibility.~      Individuals diagnosed with recurrent depression will undergo an 8-week mindfulness training~     program. Participants' depressive symptoms as well as their performance on measures of~     attention and cognitive flexibility will be examined. Participants will be assigned to~     mindfulness training or a wait-list control group. Half of the participants will be examined~     before and after the mindfulness training program and the other half will be tested 8-weeks~     apart and then begin their training.~   "
84733|NCT02457923|"~     Using a community-based, cluster randomized controlled trial design (cRCT) the investigators~     will examine the impact of an integrated m-health package -(M- SAKHI) for mothers on~     appropriate infant feeding practices, starting in the first / second trimester of pregnancy~     to 24 months after delivery, to improve child feeding practices and child growth, and reduce~     the prevalence of undernutrition in their children. This will result in two treatment groups.~     The clusters for the trial will be villages under the administrative area of ASHAs~     (Accreditated Social Health Activists). Villages with a population of 1000- 2000 (ranging~     from 751 to 2000) with 1 ASHA will be randomized to receive intervention (intervention~     villages) or continue existing delivery of care (control villages). The data will be~     collected using a longitudinal design because the investigators want to study the impact of~     intervention on the mothers starting at pregnancy until her infant is 24 month old.~   "
84734|NCT02457910|"~     This partially randomized phase Ib/II trial studies the side effects and best dose of~     taselisib when given together with enzalutamide and to see how well they work in treating~     patients with androgen receptor positive triple-negative breast cancer that has spread to~     other places in the body. Taselisib is a PI3K inhibitor. The PI3K pathway is involved is~     cancer growth. Androgen may cause the growth of tumor cells. Enzalutamide may stop the growth~     of tumor cells by blocking the androgen receptor from working. Giving taselisib with~     enzalutamide may be a better treatment for patients with breast cancer.~   "
84735|NCT02457897|"~     Background:~      - Insulin receptor mutation causes high blood sugars and sometimes diabetes complications.~     Researchers want to see if thyroid hormone helps.~      Objectives:~      - To see if thyroid hormone treatment changes how the body handles sugar in people with~     insulin receptor mutation and improves blood sugar in people with diabetes.~      Eligibility:~      - People ages 12 65 with an insulin receptor mutation.~      Design:~        -  Study part 1:19-day clinic stay. Participants will be monitored for 4 days. Then for 15~          days they will take a thyroid hormone pill 3 times a day. Participants will have:~        -  Blood tests.~        -  Heart rate and skin temperature monitored.~        -  All their food provided.~        -  Two 5-hour sessions in a special room. They will wear special clothes and sometimes sit~          still.~        -  Two small tubes inserted in veins. One will deliver tiny amounts of sugar and fat with a~          non-radioactive tracer. Participants will also drink water with a tracer. The other tube~          will collect blood.~        -  A sweet drink. Participants may have finger stick blood sugar tests.~        -  Glucose-monitoring device inserted into body fat for two 24-hour periods.~        -  Adults may have samples of fat and muscle taken.~        -  Heart ultrasound.~        -  PET-CT scan in a machine. An intravenous catheter will be placed in an arm vein. A small~          amount of radioactive substance will be injected.~        -  DEXA scan of body fat and bone density.~        -  Participants with poorly controlled diabetes will then take thyroid hormone at home for~          6 months. They will have blood drawn and sent to the study team monthly.~        -  After about 3 months, they will have an overnight visit. After 6 months, they will have~          a 4-day visit.~   "
84736|NCT02457884|"~     Diabetic macular oedema (DMO) is a sight-threatening problem for diabetic patient who has~     swelling in macula. Patients with DMO can receive laser treatment and achieve good acuity~     finally. However, some patients still have difficulties in reading even after proper~     treatment.~      In this project, the investigators aimed to explore the effectiveness of different training~     paradigms in improving reading performance in patients with DMO.~   "
84737|NCT02457871|"~     The specific study aims are to: 1) examine differences between an Ecological Nursing Case~     Management (ENCM) treated group and a comparison group on self-efficacy, SM behaviors, and~     health status to establish effect sizes needed for a future large randomized controlled~     trial; 2) explore the dose-response of specific elements of the ENCM intervention; and 3)~     examine moderating effects of gender and perceived stress on the intervention effect. This is~     a two-group randomized experimental study with repeated measurements. Clients in the~     treatment group (n=25) will receive the individualized ENCM and those in the comparison group~     (n=25) will receive usual clinic care. Data will be collected at baseline, 1, 3, and 6 months~     to capture the immediate, short and longer term effects of the intervention.~   "
84738|NCT02457858|"~     In this study, the investigators hypothesize that the addition of antioxidant BMX-010 to~     perfusion solution, digestion solution and culture medium during islet isolation process, can~     lead to greater preservation of islet mass and metabolic function, such as improved islet~     yield, viability, and functional potency.~      This pilot study will involve up to 10 participants from the islet transplant waiting list at~     the Clinical Islet Transplant Program. All participants will receive islets isolated with the~     medication BMX-010. This is to assess the primary safety of BMX-010 on pancreata and islets.~     BMX-010 will be used only in the islet isolation process, and will not be given to~     participants as medication.~   "
84739|NCT02457845|"~     This study is a clinical trial to determine the safety of injecting G207 (a new experimental~     virus therapy) into a recurrent or progressive brain tumor. The safety of combining G207 with~     a single low dose of radiation, designed to enhance virus replication and tumor cell killing,~     will also be tested. Funding Source - FDA OOPD~   "
84740|NCT02457832|"~     The purpose of this research study is to learn more about brain activity when individuals~     with and without Parkinson disease (PD) move their lower limbs. The investigators also want~     to see if and how two different types of partnered dance affect brain activity in individuals~     with and without PD. Testing will take place at the Atlanta VA Medical Center and at Emory~     University. The investigators expect to enroll about 140 people for this study over a~     five-year period.~   "
84741|NCT02457819|"~     This is an open label 26 week extension study for subjects who completed SEP360-202.~   "
84742|NCT02457806|"~     To compare the efficacy of Kovacaine Mist administered bilaterally to that of Kovacaine Mist~     administered unilaterally with respect to global profound pulpal anesthesia in target teeth~     numbers 4-13.~   "
84743|NCT02457793|"~     This is a two-stage dose-escalation study to assess the safety, tolerability and effects of~     oral dosing of cobimetinib and GDC-0994 administered in combination in patients with~     histologically confirmed, locally advanced, or metastatic solid tumors for which standard~     therapies either do not exist or have proven ineffective or intolerable.~   "
84744|NCT02457780|"~     Many responders to the World Trade Center (WTC) disaster continue to experience significant~     mental and physical health problems. Two of the most common health problems, post-traumatic~     stress disorder (PTSD) symptoms and respiratory illness, often occur together. Mental health~     conditions, such as PTSD, make physical illnesses worse and interfere with treatment. The~     primary goal of this study is to test a mind-body treatment designed to reduce both PTSD and~     respiratory symptoms.~   "
84745|NCT02457767|"~     In this study the investigators measure and optimize the patients waiting time in the~     preanesthetic assessment by integrating an interactive mobile device. The aim of this study~     is to observe whether the patients mean waiting-time is reduced by the use of a special~     mobile application (Anaest-App) and, as a result , raises patient-satisfaction.~   "
84820|NCT02456792|"~     The purpose of this study is to compare the efficacy of in vitro fertilization (IVF) versus~     laparoscopic ovarian drilling (LOD) in infertile women having clomiphene citrate (CC)~     resistant polycystic ovarian syndrome (PCOS).~   "
84746|NCT02457754|"~     Several studies have shown a high association between physical fitness and present and future~     health. Two of the main epidemics of the industrialized world are obesity and osteoporosis,~     diseases that could be prevented with early interventions from childhood. Both, physical~     activity and physical fitness have shown an association with these diseases, but tools for~     assessing them in early ages are still in development. Moreover, there is a lack of physical~     fitness reference values in preschool children and the relation of pathologies with physical~     fitness in these ages is still to be demonstrated. Therefore, through a simple and precise~     methodology displayed in the school and adapted for the younger we intend to: Provide a~     combination of safe and precise field tests to evaluate health related physical fitness in~     preschool children. Analyze body composition, risk of overweight, obesity and low mineral~     density and their relation with physical activity. The evaluation of these health-related~     physical fitness variables in early ages is of great interest to clinic and public health.~   "
84747|NCT02457741|"~     This study will test the validity of a new approach to assess alveolar recruitability at the~     bedside in comparison to direct measurements of lung volume and derecruitment.~   "
84748|NCT02457728|"~     Fixation of mesh and peritoneal closure during TAPP repair using n-butyl cyanoacrylate.~   "
84749|NCT02457715|"~     This is a parallel group, single institution, prospective clinical study. The purpose of this~     study is to assess whether the Jawbone Up 24, a consumer based accelerometer, can be a~     feasible tool to study physical activity in cancer patients and patients with Amyotrophic~     Lateral Sclerosis (ALS).~   "
84750|NCT02457702|"~     The researchers will recruit patients with liver disease at Parkland Hospital. Patients will~     fast overnight, and the next morning will receive an oral mixture of [U-13C3]glycerol (25~     mg/kg) plus unlabeled glycerol (25 mg/kg). The total dose of glycerol will be 50 mg/kg in 100~     milliliters of water. The taste is slightly sweet. Blood will be drawn at 60 min and 120 min~     after the ingestion. Blood glucose will be isolated and analyzed by NMR. The presence of~     [5,6-13C2]- and [4,5-13C2]glucose indicates preserved mitochondrial function. The researchers~     anticipate that patients with severe liver disease will show a decrease in mitochondrial~     function and will inform biosynthetic function of liver mitochondria.~      After the first 6 successful exams (see power analysis, below), healthy volunteers (age-,~     gender-, and race-matched) will be studied at the AIRC and subject to the same protocol.~   "
84751|NCT02457689|"~     CUT*HIVTHER 001 is a randomised placebo-controlled Phase I/II study aimed at exploring the~     safety and immunogenicity of two different modes of delivery of a GTU® DNA plasmid vaccine~     (GTU®-multiHIV B clade) in HIV infected volunteers on antiretroviral therapy (ART):~        -  Transcutaneous (TC) delivery to enhance intramuscular delivery and~        -  Electroporation (EP) enhanced intramuscular delivery Participants will be randomised~          1:1:1 to TC:EP:saline for the purposes of analysis. Half the saline group will receive~          TC saline and half will receive EP saline.~           30 HIV infected male and female volunteers aged 18-45 years, who have been on ART for at~          least 6 months with 2 or more HIV plasma viral load measurements < 50 copies HIV RNA/ml~          prior to enrolment.~      The investigational HIV-1 vaccine GTU®-MultiHIV B clade encodes for a MultiHIV antigen which~     is a synthetic fusion protein consisting of full-length polypeptides of Rev, Nef, Tat, p17~     and p24 and containing more than 20 Th and CTL epitopes of protease, reverse transcriptase~     (RT) and gp160 regions of the HAN2 HIV-1 B clade.~      Vaccine is provided in sealed vials at 2mg/ml, and a single 1ml IM injection of 2mg~     GTU®-MultiHIV DNA IM (into the thigh) is required to deliver a 2mg dose. Individuals in Group~     2 will receive a further 0.4mg GTU®-MultiHIV DNA in 0.2ml administered by TC, a novel~     needle-free method of vaccine delivery.~   "
84752|NCT02457676|"~     This study on children with fetal alcohol spectrum disorder (FASD) aims to (i) characterize~     their self-regulation deficits, a process important for controlling emotions and behavior,~     (ii) describe brain structure and function underlying self-regulation, and (iii) determine~     whether training to improve self-regulation abilities changes brain and behavior. Individuals~     with FASD have a high risk of cognitive and social deficits, which reflect their difficulties~     in self-regulation and may lead to mental health concerns in adulthood. Importantly, early~     intervention improves long-term outcome. However the full extent of self-regulation problems~     in FASDs is unknown and the underlying neuroanatomy has not been fully described.~     Furthermore, information on how to best treat children with FASDs is lacking. Thus, the~     investigators propose three studies with a sample of 8-12 year old children, 40 with FASDs~     and 20 typically developing controls. In Study 1, the participants will be evaluated on~     cognitive and social self-regulation abilities using clinical and experimental tests. In~     Study 2, the participants will undergo a 1-hour MRI scanning session to obtain measures of~     their brain structure and function. In Study 3, FASDs will be randomly assigned to an~     immediate or delayed treatment group. The immediate group will undergo 12-weeks of therapy~     with the Alert Program for Self Regulation®. On conclusion of training, all will repeat~     Studies 1 and 2 and following this retest, the delayed treatment group will undergo training.~     The investigators will evaluate change in cognitive and social behavior and in brain~     structure and function by comparing performance and neuroimaging findings before and after~     the intervention. The investigators expect Alert training to significantly improve behavior~     and alter brain regions important for self-regulation. The findings will yield important~     information for improving self-regulation in FASDs and mitigating the development of mental~     health challenges.~   "
84753|NCT02457663|"~     In this prospective, multi-center study, 200 patients from four participating Texas burn~     hospitals will be enrolled from admission to discharge. The clinical research study team will~     collect approximately 11 serum samples and clinical data related to sepsis and infection~     predictors from severely burned adult patients, ages 18-80 years old. All serum samples from~     participating sites will be shipped to the lead site, University of Texas Medical Branch. The~     University of Texas Medical Branch will then validate previously identified biomarkers while~     simultaneously identifying novel biomarkers through discovery proteomics.~   "
84765|NCT02457507|"~     Background: Older diabetic people are at greater risk of cognitive decline than non-diabetic~     people. Vitamin B12 deficiency in older people is associated with cognitive impairment and~     Alzheimer's disease. Vitamin B12 deficiency may therefore contribute to cognitive decline in~     older diabetic people.~      Objective: To determine whether the correction of mild vitamin B12 deficiency in cognitively~     normal older diabetic people reduces the incidence of cognitive decline.~      Design: randomized, double blind, placebo controlled trial Subject: Cognitively normal~     diabetic outpatients aged 70 years or older with plasma vitamin B12 150-300 pmol/L in medical~     and family medicine/ general outpatient clinics.~      Procedure: After excluding those with clinical manifestations of vitamin B12 deficiency and~     without family member who can reliably inform on cognitive functioning (personal contact at~     least once a week), eligible patients will be invited to participate in this clinical trial.~     After obtaining written consent, research assistant (RA) will record demographic and clinical~     information from the subjects and perform neuropsychological tests - 1. Clinical dementia~     rating scale (CDR), 2. neurocognitive test battery (see below) 3. Chinese Mini mental state~     examination (MMSE), 4. Geriatric depression scale (GDS). Fasting blood will be taken for~     serum methylmalonic acid (MMA). Those with cognitive impairment and significant comorbidities~     will be excluded.~      264 eligible subjects will be randomly assigned to take either two Vitamin B12 500 microgram~     or two identical looking placebo tablets once daily for 27 months.~      All subjects or family caregivers are reviewed in the research clinic every 12 weeks in which~     the research assistant performs a pill count and dispenses the trial tablets. At 9 monthly~     intervals, the subjects will have neurocognitive test battery repeated at research clinic.~     CDR will be repeated at month 18 and 27. At month 9 and 27, fasting serum MMA and vitamin B12~     will be repeated.~   "
84754|NCT02457650|"~     Background:~      Autologous T cells engineered to express a T cell receptor (TCR) targeting NY-ESO-1 will be~     infused back to patients with NY-ESO-1- expressing malignancies. The patients pretreated with~     a lymphodepleting preconditioning regimen will be monitored after infusion of anti-NY-ESO-1~     TCR-transduced T cells for adverse events, persistence of anti-NY-ESO-1 TCR-transduced T~     cells and treatment efficacy.~      Objectives:~      To evaluate the safety and the efficacy of anti-NY-ESO-1 TCR-transduced T cell-based~     immunotherapy for patients with NY-ESO-1- expressing malignancies.~      Eligibility:~      Patients older than one year of age, who have relapsed or refractory malignancies that~     express both NY-ESO-1 and human leukocyte antigen (HLA)-A2 molecules.~      Patients must have adequate organ functions.~      Design:~        -  Peripheral blood from patients will be collected for isolation of peripheral blood~          mononuclear cells (PBMCs), which will be transduced with a lentiviral or retroviral~          vector encoding an HLA-A2 restricted anti-NY-ESO-1 TCR gene.~        -  Patients will receive a lymphodepleting preconditioning regimen to prepare their immune~          system to accept modified T cells.~        -  Patients will receive an infusion of their own modified T cells. They will remain in the~          hospital to be monitored for adverse events until they have recovered from the~          treatment.~        -  Patients will have frequent follow-up visits to monitor the persistence of modified T~          cells and efficacy of the treatment.~   "
84755|NCT02457637|"~     Acute on chronic liver failure (ACLF) is a distinct entity encompassing the acute~     deterioration of liver function, culminating in multiple organs failure and high short-term~     mortality. Currently, there are differences in definitions and descriptions between western~     and eastern types of ACLF, especially in the definition of chronic liver disease and its~     precipitating events. The CANONIC (EASL-CLIF Acute-on-Chronic Liver Failure in Cirrhosis)~     study put forward CLIF-SOFA (chronic liver failure-sequential organ failure assessment)~     scores as the clinical diagnostic criteria of ACLF in 2013. Although the Asian Pacific~     Association for the Study of the Liver (APASL) reached a consensus for diagnostic criteria of~     ACLF in 2008, which is however based on expert opinion, rather than prospectively collected~     and validated data. To clarify the eastern type of ACLF (HBV related) and establish whether~     the eastern and western (alcoholic related) types of ACLF are homogenous, the investigators~     are launching this prospective multicenter clinical trial. The investigators are going to~     identify three key points: (1)Whether HBV and non-HBV ACLFs are belong to a homogenous~     disease entity which share the same diagnostic criteria, disease grades classification and~     prognostic model; (2) Whether acute deteriorating patients from cirrhosis or from mild~     fibrosis (S1-S2) belong to a homogenous entity? (3)To clarify if there are heterogenous~     groups in APASL criteria diagnosed ACLF patients.~      13 Chinese national wide liver centers each of whose total beds are around 500 have been~     included. Extra liver centers may join later. Continuous hospitalized chronic liver disease~     patients of various etiologies (including both cirrhotic and non-cirrhotic) with acute~     decompensation (AD) or acute hepatic injury (ALI) (aminotransferase > 3NL(normal level)) will~     be recruited from January to December 2015. Biochemical parameters, organ failure, mortality~     and liver transplantation rate will be collected and evaluated at day 1,4,7,14,21 and 28~     after enrollment. Considering there will lack of liver biopsy in most of the patients, both~     CT and FibroScan as supplementary methods will be used for differentiating non-cirrhotic~     patients, especially hepatitis patients with mild fibrosis, from cirrhotic patients. The~     patients will be continuously followed up once a month until the 24th month after hospital~     discharging. During follow-up, patients will be hospitalized again whenever they have new ALI~     or AD. Similar data will be collected reference to their prior admission and follow-up will~     restart. Through continuous collection, the investigators will acquire data about the~     patients from stable chronic liver disease to deterioration of the disease. Then these data~     will be analyzed according to the questions that the investigators hope to resolve.~   "
84756|NCT02457624|"~     Experienced endoscopists will perform endoscopy during the study period and the detection~     rate of gastric premalignant lesion, correlation between endoscopic and serologic diagnosis~     of premalignant lesions and inter-observer agreement rate will be analyzed before and after~     the education.~   "
84757|NCT02457611|"~     The primary objectives of this study are to determine the antiviral efficacy, safety, and~     tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with~     acute genotype 1 or 4 hepatitis C virus (HCV) and chronic human immunodeficiency virus~     (HIV)-1 co-infection.~   "
84758|NCT02457598|"~     The primary objectives of this study are to evaluate the safety, tolerability,~     pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of tirabrutinib~     (ONO/GS-4059) in combination with other targeted anti-cancer therapies in adults with~     relapsed or refractory B-cell lymphoproliferative malignancies.~      This study consists of two parts: Dose Escalation and Dose Expansion. During the dose~     escalation phase, participants will be sequentially enrolled in a standard 3 + 3 dose~     escalation study design, to receive oral tirabrutinib combined with idelalisib entospletinib~     +/- obinutuzumab. The Dose Expansion Phase will enroll additional participants with a single~     B-cell lymphoproliferative malignancy disease type to further evaluate efficacy, safety,~     tolerability, PK, and pharmacodynamics.~   "
84759|NCT02457585|"~     Clinical study of anti-tumor necrosis factor therapy in patients with Takayasu arteritis.~      This study is single arm (anti Tumor necrosis factor therapy only) clinical trial. Enrolled~     patients will be 11~   "
84760|NCT02457572|"~     Pulse pressure variation (PPV) is a well-known dynamic preload indicator to predict fluid~     responsiveness. However, its usefulness in open-chest conditions has been equivocal. The~     investigators evaluated whether PPV measured during Valsalva maneuver can predict fluid~     responsiveness after sternotomy.~   "
84761|NCT02457559|"~     This study will determine the long-term safety, tolerability, and efficacy of tirabrutinib in~     adults in a prior tirabrutinib study and whose disease had not progressed on the parent~     study. The dosing regimen will be based on the prior dosing regimen from the parent study.~   "
84762|NCT02457546|"~     The objective of this study is to evaluate the safety and efficacy of EVICEL® Fibrin Sealant~     (Human) for use as an adjunct to sutured dural repair in cranial surgery.~   "
84763|NCT02457533|"~     To investigate the effects of patient counseling by telephone on Quality of Life and the use~     of Health care system.~   "
84764|NCT02457520|"~     This is an uncontrolled, open-label study being conducted in approximately 200 healthy males,~     non-pregnant, non-nursing females, age 12 to 45 years, with severe recalcitrant nodular acne.~      ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day will be administered for 4 weeks followed by~     1.0 mg/kg/day for 16 weeks. Female subjects consenting to use two forms of birth control or~     abstinence are included.~   "
84766|NCT02457494|"~     The purpose of this study is to define the cause of renal stones and the risk pattern for~     recurrence of renal stones episodes (any kind of stones) in HIV1 patients.~   "
84767|NCT02457481|"~     The purpose of this research study is to evaluate a newly developed embryo culture media~     system for human clinical use in ART.~   "
84768|NCT02457468|"~     The purpose of the coflexCOMMUNITY observational study is to collect information on patients~     with spinal stenosis undergoing back surgery with the coflex® implant, and to look at their~     outcomes and the cost-effectiveness of this procedure.~   "
84770|NCT02457442|"~     Recently a new model for the interaction of sevoflurane propofol and remifentanil was~     developed. The potency of any combination of the three drugs is defined as probability that a~     subject tolerates laryngoscopy without movement response. The model allows to compare the~     potency of intravenous and inhalation anesthetics. If the model is valid also for other~     stimuli than laryngoscopy and for other responses (e.g. blood pressure or heart rate increase~     upon stimulation). If the model is valid equipotent concentrations of sevoflurane and~     propofol the same remifentanil concentration would be sufficient to suppress hemodynamic~     response to a given stimulus. This will be investigated it the study.~   "
84771|NCT02457429|"~     Gastro-oesophageal reflux (GORD) and its extraoesophageal manifestations present with a~     variety of symptoms in both adult and paediatric populations. In children the effects of~     refluxate above the upper oesophageal sphincter (UES) has been implicated as a contributory~     factor in the underlying pathological processes of a number of conditions including apnoea,~     asthma, chronic cough, subglottic stenosis, chronic rhinosinusitis and otitis media. The~     absence of typical symptoms in addition to the inability to obtain a formal symptom history~     from a young paediatric population contributes to the difficulty in establishing a diagnosis.~     At present there are no studies or data directly measuring extraoesophageal reflux and its~     correlation to oesophageal pH monitoring in children.~      The use of twenty-four hour oesophageal pH monitoring is regarded as the established~     technique for diagnosis of GORD, however this technique has been less reliable for detecting~     extra-oesophageal reflux. The investigators intend to use the Dx-pH Measurement system, a~     sensitive and minimally invasive transnasal device, to assess the feasibility and validate~     its use in a paediatric population.~   "
84772|NCT02457416|"~     The purpose of the study is to identify prognostic markers and possible success rate of~     tolerance induction to peanut allergens in children allergic to peanut.~   "
84773|NCT02457403|"~     A prospective, randomized clinical trial comparing blood product use and bleeding events~     during and after endoscopic or neurosurgical procedures in patients with cirrhosis and~     coagulopathy: Rotational Thromboelastometry (ROTEM) vs. conventional therapy (SCARLET).~   "
84774|NCT02457390|"~     Laparoscopic ultrasound examination performed during surgery for primary cancer of the colon~     and rectum (CRC) has been shown to be able to detect liver metastasis that are not recognized~     by conventional computer tomography (CT scan) prior to surgery.~      Today most of the colorectal cancer resections are performed by laparoscopy, but robotic~     technology is gradually developed in an attempt to overcome some of the limitations~     characterized by laparoscopy. The use of contrast enhanced laparoscopic ultrasound~     examination (CE-LUS) of the liver during robot-assisted CRC surgery has not been studied, and~     this despite the fact that it seems technically possible to perform.~      With this project we will investigate whether CE-LUS associated with robotic surgery for CRC~     is technically feasible and whether it will be able to detect synchronous liver metastases~     that have not been detected on the preoperative imaging modalities.~   "
84775|NCT02457377|"~     A 5-mm non-absorbable Mersilene polyester suture, with adjacent partially straightened blunt~     needles, is introduced into the abdominal cavity through the 5-mm trocar. However, flattening~     the curvature of the needles, while introducing the tape into the abdomen, will eventually~     pose a challenge during placement of the stitch (the needles' curvatures guarantee that the~     tissue penetration is done away from the uterine vessels).~      To overcome this problem, the following method was devised. A one cm suprapubic incision is~     made on the abdomen with a scalpel short of the peritoneum. A needle holder loaded with the~     needle is pushed through the incision until the tip is seen inside the peritoneal cavity. A~     grasper from one of the flank ports receives the tip and the needle is delivered carefully~     (FIGURE 1). The rest of the tape is pulled until the blunt end of the other needle appears,~     to be delivered in the same way but in the reverse order.~      • Operative Steps The vesico-uterine peritoneum is opened using scissors & the urinary~     bladder is dissected downwards from the lower uterine segment to expose the uterine vessels~     anteriorly on both sides . Both needles are passed through the lower uterine tissue medial to~     uterine vessels on the right & left sides (from anterior to posterior) . Then, both needles~     are passed through the remaining cervical tissue medial to uterosacral ligaments towards the~     posterior vaginal fornix (on the right & left sides) guided by laparoscopic illumination .~     When the needles' blunt ends pierce the vaginal vault, the assistant pull them through the~     posterior vaginal fornix . After trimming of both needles, the Mersilene tape is tied tightly~     behind the intravaginal segment of the cervix with five knots & the ends of the stitch are~     trimmed. The vesico-uterine peritoneum is then reapproximated over the laparoscopic cerclage~     with a running (00) Monocryl suture that is tied intracorporeally.~   "
84776|NCT02457364|"~     Ventral hernias are among the most common surgical diseases among patients.The natural~     history of patients with ventral hernias who are managed non-operatively is unknown. The aim~     of this prospective trial is to document the natural history of patients who are undergoing~     initially non-operative management. The investigators hypothesize that 1) the risk of~     emergency ventral hernia repair is low, 2) the risk of elective ventral hernia repair is~     high, and 3) patients managed non-operatively will develop increasing hernia size and symptom~     progression. This is a prospective observational study of all patients undergoing~     non-operative management at LBJ General Hospital. Patients will be consented and then~     followed for 5 years. Phone interviews will be done with these patients yearly to assess~     surgical and medical history, information about their hernia, including pain level due to the~     hernia, as well as function and quality of life.~   "
84777|NCT02457351|"~     To evaluate the effect of itraconazole, a strong CYP3A4 inhibitor, on the pharmacokinetics of~     roniciclib in cancer patients.~      To assess safety and tolerability of roniciclib dosing when administered with and without~     itraconazole in cancer patients~   "
84778|NCT02457338|"~     The purpose of this study is to determine if supplementing healthy term infants delivered by~     C-section or vaginal delivery who only consume breastmilk with a probiotic for 21 consecutive~     days increases levels of bacteria in infants' stool.~   "
84779|NCT02457325|"~     The present clinical trial randomized compared the clinical efficacy of the local anesthetics~     articaine in two concentrations, 2% and 4%, in association with 1:200,000 adrenaline, for the~     removal of lower third molars. Onset, duration of postoperative analgesia, duration of~     anesthetic action on soft tissues, intraoperative bleeding, hemodynamic parameters,~     postoperative mouth opening and wound healing at the 7th postoperative day were evaluated.~     For this purpose, 50 healthy volunteers underwent removal of symmetrically positioned lower~     third molars, in two separate appointments (one to two months apart), under local anesthesia~     with either articaine 2% or 4% (both with 1:200,000 adrenaline) in a double-blind, randomized~     and crossed manner.~   "
84780|NCT02457312|"~     The present study aims at studying the effect of letrozole in early pregnancy in placenta and~     decidua including the progesterone receptor and the apoptotic factors.~   "
84783|NCT02457273|"~     Title of Study:~      An Open-Label, Single-Arm, Two-Stage, Multicenter, Phase II Study to Evaluate the Efficacy~     and Safety of TLC388 as Second-line Treatment in Subjects with Poorly Differentiated~     Neuroendocrine Carcinomas~      Investigational product:~      Lipotecan®*~      *Lipotecan® is the trade name of TLC388 HCl, a Topoisomerase I inhibitor)~      Phase of development:~      Phase II~      Number of subjects:~      Plan to enroll 44 subjects~      Objectives:~      Primary objectives:~      To determine the objective response rate~      Secondary objectives:~      To evaluate Disease control rate, Progression free survival, Overall survival, Safety profile~     and Biomarkers~   "
84784|NCT02457260|"~     Studies have demonstrated nitrite therapy increases adenosine triphosphate (ATP) synthesis in~     skeletal muscle mitochondria concomitant with reduced whole-body oxygen cost during steady~     state exercise. Our own work has demonstrated safety and efficacy of an FDA investigational~     new drug (IND) approved sodium nitrite (10 milligram [mg]) capsule, and its utility to~     upregulate the sirtuin 3 adenosine monophosphate protein kinase (SIRT3-AMP) pathway of~     skeletal muscle of younger heart failure (HF) patients. It now seems exceptionally logical~     and opportune to apply these insights to older HF patients and to delineate mechanisms of~     disease and aging that respond to nitrite therapy.~   "
84785|NCT02457247|"~     The purpose of this study is to compare the preference of Calcichew D3 500/400 (containing~     500 mg calcium and 400 IU of vitamin D) with Adcal-D3 600/400 (containing 600 mg of calcium~     and 400 IU of vitamin D) in Test Group 1, and to compare Calcichew D3 500/800 (containing 500~     mg calcium and 800 IU vitamin D) with Kalcipos-D 500/800 (containing 500 mg of calcium and~     800 IU of vitamin D) in Test Group 2.~   "
84786|NCT02457234|"~     The purpose of the Traditions study was to examine the influence of cultural immersion on~     willingness to try fruits and vegetables among children, 3-12 y, in Guam. The primary~     objective of this study was to examine willingness to try fruits and vegetables and fruit and~     vegetable intake among children attending three existing summer camp programs: a cultural~     immersion camp, a university day camp, and a recreational sports camp. The primary hypothesis~     was that children attending the cultural immersion camp would have higher willingness to try~     fruits and vegetables (WillTry score) and a higher intake of fruits and vegetables compared~     to children attending both, the university day camp and recreational sports camp, without~     cultural immersion.~      A pre-post, quasi-experimental design was used to evaluate 3 summer camps with different~     exposure levels of cultural immersion. High, moderate, and zero (cultural) exposure was~     provided by a cultural immersion camp (CIC), a university-based day camp (UDC), and a~     recreational sports camp (RSC), respectively. CIC delivered 4 culturally adapted nutrition~     lessons within the context of Chamorro cultural traditions as part of the cultural immersion~     camp activities. The UDC delivered the same lessons within a physiology framework. The RSC~     was without nutrition lessons and cultural immersion. Children 3-12 years old registered in~     any of the three summer camp programs were eligible to participate. Data collection was~     primarily administered at two assessment periods: before (± 2 weeks) and after (± 1 week)~     each summer camp program. Children's willingness to try fruits and vegetables, the primary~     outcome, was assessed with the interview-administered Adapted WillTry tool. The secondary~     outcome was fruit and vegetable intake as servings/day in the CIC to UDC only. Fruit and~     vegetable intake was assessed using the mobile food record (mFR), which is an app running on~     an iPod Touch based on the technology assisted dietary assessment (TADA) protocols. Outcomes~     examined Adapted WillTry post-scores for local novel and local common fruits and vegetables~     and fruit and vegetable servings/day using multivariate regression models adjusting for the~     relevant pre-score, sex, age, ethnicity, dose, BMI percentile, and parent's cultural~     affiliation. Therefore, additional measures like sociodemographic information, anthropometry~     (i.e. heights and weights), and parent's cultural affiliation were collected to account for~     potential confounders.~   "
84787|NCT02457221|"~     The objective of this study is to evaluate the efficacy and safety of Tacrolimus capsules for~     induction remission in patients with lupus nephritis, and compare the efficacy and safety~     with Cyclophosphamide injections.~   "
84788|NCT02457208|"~     This is a prospective descriptive and pharmacokinetic study will be conducted among newly~     diagnosed patients registered in the two SMRU TB clinics located on the Thai-Myanmar border.~     This study aims to recruit (1) 30 adults with HIV co-infection and (2) 30 adults without HIV~     co-infection in one year. Patients will be given the standard 6 month anti-TB drugs as per~     WHO guidelines.~   "
84789|NCT02457195|"~     The objective of the study is to evaluate the efficacy and safety of adding transdermal~     preparation of granisetron (Sancuso ®) to the current postoperative nausea and vomiting~     (PONV) standard prophylaxis regimen with dexamethasone and ondansetron in patients with the~     previous history of severe, particularly delayed and/or post-discharge, PONV and undergoing~     surgical procedure under general anesthesia.~      The specific aims of the study include:~        1. efficacy of the investigated therapy in prevention of PONV up to 120 hours after surgery~        2. incidence and seriousness of the observed side effects~        3. ability of patients to self-administer preoperatively and maintain the investigated~          patch during the perioperative period~        4. level of satisfaction with the preoperative PONV prophylaxis.~   "
84790|NCT02457182|"~     Interstitial cystitis/bladder pain syndrome (IC/BPS) is a poorly understood disease with~     unreliable treatments. Although it is not known what causes it for certain, we do know that~     life stressors may make the disease worse or cause flares. Mindfulness Based Stress Reduction~     (MBSR) is an 8 week class focused on meditation and other techniques that the investigators~     think may be helpful to people with IC/BPS. This trial will assign participants to an MBSR~     class or usual care for their IC/BPS to see if the MBSR class would be helpful for their~     disease.~   "
84791|NCT02457169|"~     The intervention under examination is designed to promote parents' school engagement~     following the transition from Early Intervention (EI) to preschool for parents of young~     children who were diagnosed with ASD through our screening and assessment protocol. The brief~     intervention employs principles of motivational interviewing to address not only the~     particular child characteristics and needs associated with ASD but also the unique,~     system-related challenges of navigating the special education system and advocating for~     appropriate services. Motivational interventions with parents are designed to elicit parents'~     specific, action-oriented goals for themselves and their children, enhancing motivation to~     pursue change, and addressing and resolving obstacles or sources of ambivalence.~      By identifying and capitalizing on parents' strengths, empowering parents to develop specific~     goals, and improving parents' readiness to engage actively with their children's school,~     teacher, and educational team, we expect that this brief intervention will lead to higher~     levels of parental school involvement, higher special education engagement, and closer and~     more productive parent teacher relationships.~   "
84792|NCT02457156|"~     The purpose of this study is to compare two different techniques of performing a pancreatic~     anastomosis; Cattell-Warren versus Blumgart to determine if a Blumgart anastomosis reduces~     pancreatic remnant leak, post-operative complications and overall length of hospital stay.~   "
84793|NCT02457143|"~     This randomized trial aims to understand how effective a reminder letter is compared to a~     reminder phone call in improving breast, cervical and colorectal cancer screening rates and~     reducing screening disparities.~   "
84794|NCT02457130|"~     Patients with type 2 diabetes mellitus (T2DM), have a high prevalence of suboptimal response~     to clopidogrel (up to 40%). This impaired response to antiplatelet drugs has been~     consistently associated with a higher risk of adverse ischemic outcomes. Different strategies~     have been suggested to overcome variability in response to clopidogrel and improve clinical~     outcomes in diabetic patients. One of these strategies is the use of newer P2Y12 inhibitors,~     such as ticagrelor, with more potent and consistent platelet inhibitory effects compared to~     clopidogrel. In summary, since patients with T2DM continue to have enhanced platelet~     reactivity despite the administration of commonly used dual antiplatelet therapy with aspirin~     and standard doses of clopidogrel, newer and more potent antiplatelet treatment strategies~     are warranted in this high-risk population. The purpose of the present study is to compare~     platelet inhibitory effects achieved with ticagrelor versus clopidogrel, both on top of~     aspirin therapy, in patients with type 2 DM and stable coronary artery disease.~   "
84795|NCT02457117|"~     This study is a registry to monitor quality of life and clinical outcomes in patients with~     clinically localized breast cancer who have received stereotactic accelerated partial breast~     irradiation via CyberKnife.~   "
84796|NCT02457104|"~     The investigators long-term goal is to understand how PPIs influence energy balance in both~     obese and normal-weight individuals. The overall goal of this study is to determine whether~     PPI use causes detrimental changes in the composition and functional properties of the gut~     microbiome, and whether any such effects are mediated by altered responses of human fatty~     acid receptors (e.g., GPR41/43).~   "
84797|NCT02457091|"~     The purpose of this study is to test different types of exercise training for people with~     multiple sclerosis (MS). The exercise program is based on physical activity guidelines that~     have been developed specifically for people with MS. The investigators believe these~     guidelines will be effective for improving physical fitness and function in persons with~     mild-to-moderate MS.~   "
84798|NCT02457078|"~     This project will investigate whether adding nutritional supplements to the diet will have~     beneficial effects on the development of infant brain networks (assessed at 4 and 9 months of~     age). The nutritional supplement will contain lutein (typically found in leafy~     vegetables),docosahexaenoic acid (DHA; a fatty acid typically found in cold-water fish such~     as salmon or tuna), and of vitamin E.~   "
84799|NCT02457065|"~     A patient's sun-related behavior greatly influences the likelihood of that patient developing~     melanoma, the most dangerous form of skin cancer. Prior research shows current education~     strategies on inducing preventative behaviors such as wearing sun-protection clothing and~     wearing sunscreen are inadequate at effectively changing behavior when used in isolation --~     patients are aware of the dangers of not engaging in these preventative measures but forgo~     them nonetheless.~      We are investigating methods to positively influence sun protection behaviors among melanoma~     survivors and their families. The first objective is to compare patient and familial sun~     exposure and cancer screening activity before and after patients' diagnosis with primary~     melanoma. The second objective is to note if hanging a Melanoma Survivor plaque in a~     melanoma survivor's bathroom will significantly affect the survivor's and broader family's~     sun exposure and cancer screening activity.~      Our sample of patients consists of survivors of primary cutaneous melanoma less than 4.0 mm~     in depth who come through the Dermatology Clinic at Dartmouth-Hitchcock Medical Center and~     voluntarily choose to participate in the study after being informed of the nature of the~     research. These patients complete a confidential survey assessing a change in sun exposure~     related activities immediately after their diagnosis. After they fill out the survey, we will~     ask them if they could nominate a family member to whom we will explain the purpose of our~     research and confidentially ask an additional set of questions to evaluate the broader impact~     of a melanoma diagnosis. From our original sample, we will randomly choose a few families who~     would display the survivor plaque in their primary bathroom. After six-twelve months, during~     the patient's follow up visit, will ask again both groups of patients and family members to~     fill out another survey to assess sun exposure related activity.~      On the surveys, no names are recorded. Everything is anonymous.~   "
84800|NCT02457052|"~     When the seat is a vehicle for disabled person, postural adaptation methodology is known and,~     on prescription, there is possibility of financial support for technical posture assists. For~     people who use a standard seat, a chair for example, there is no satisfactory existing~     hardware.~      A transportable customisable and scalable sitting positioning device (DATP device), to be~     placed on a standard seat, is a solution that might fit in the home, in specialized foster~     homes or in institutions for the elderly. Such a device has been developed but earnings on~     swallowing disorders have to be validated.~   "
84801|NCT02457039|"~     Chemobrain is an expression used to describe a cluster of chemotherapy-induced cognitive~     impairment symptoms, including problems with visual and verbal memory, forgetfulness,~     difficulty in learning, attention, concentration and coordination of multitasking and~     organization. Over 75% cancer patients experienced acute cognitive symptoms during~     chemotherapy and 17%-34% of them have long-term post-treatment cognitive deficits which can~     persist up to 10 years. Breast cancer survivors even display as high as 50%-75% prevalence of~     post-treatment cognitive impairment. Chemobrain has become an apparent quality-of-life issue~     for cancer survivors and will be encountered more frequently with the rise of the number of~     cancer survivors. There are no effective interventions available for preventing and treating~     chemobrain.~      Acupuncture is beneficial in reducing various side effects of anti-cancer treatment. It also~     shows the efficacy in improving mild cognitive impairment and other dementia disorders;~     facilitates the recovery of pathological microstructural changes of the brain. These results~     have led to the hypothesis that acupuncture is effective in preventing chemobrain and this~     preventive effect may be associated with the protection against cytokine production,~     epigenetic modification and microstructural changes of the brain.~      To test this hypothesis, an assessor-blinded, randomised controlled trial will be conducted~     to determine if a combination of DCEAS and body acupuncture could reduce the incidence and~     symptoms of chemobrain in breast cancer patients under chemotherapy compared to least~     acupuncture stimulation (LAS) as controls.~      A total of 168 breast cancer patients who are ready for chemotherapy will be randomly~     assigned to comprehensive acupuncture intervention (combined DCEAS and body acupuncture~     regimen + chemotherapy) (CAI) (n = 84) for 2 sessions per week for 8 weeks or least~     acupuncture stimulation (LAS) (minimal acupuncture + chemotherapy) (n = 84). All patients~     receive the standard chemotherapy of breast cancer. Treatment outcomes on cognitive~     performance, fatigue and the depression will be assessed.~   "
84802|NCT02457026|"~     The purpose of this prospective interventional study is to assess whether adjunctive~     verteporfin photodynamic therapy (PDT) is effective for the treatment of persistent disease~     activity in neovascular age-related macular degeneration (NV AMD), as compared to anti-VEGF~     therapy (aflibercept) alone. This study will enroll individuals with NV AMD who have~     persistent disease activity in spite of either loading dose (initial 3-5 anti-VEGF~     treatments) or maintenance (established course) anti-VEGF therapy to determine whether PDT~     can improve disease activity, facilitate sustained visual acuity gains, and decrease burden~     of frequent anti-VEGF treatments for affected patients. Risks of study are related to~     treatment with study drugs: intravenous verteporfin, intravitreal triamcinolone acetonide,~     and intravitreal aflibercept. All have been studied extensively in clinical trials and are~     established treatments used routinely in NV AMD. Adverse events will be monitored by the~     principal investigator and study team.~   "
84875|NCT02456077|"~     The purpose of this study is to determine if a multimodal Human Papillomavirus (HPV)~     immunization program carried out in pediatric and family medicine practices would be more~     effective in improving adolescent patients' HPV immunization rates than the usual care~     provided to adolescents in pediatric and family medicine practices.~   "
84803|NCT02457013|"~     1. The purpose of the study is to evaluate prospectively the clinical benefits of High flow~          nasal canula (HFNC: 2l/kg/min) versus nasal CPAP( continuous positive airway pressure)~          (n-CPAP: 7 cmH2O) in the initial management of bronchiolitis in infants.~        2. Design: non-inferiority study, prospective, controlled, randomized, multi-center.~        3. Design: Infants less than 6 month admitted in pediatric intensive care unit for~          respiratory distress (mWCAS >3) secondary to bronchiolitis but not requiring mechanical~          ventilation will be randomized in two groups: n-CPAP(nasal continuous positive airway~          pressure) or HFNC during 24 hours.~        4. Conditions of measurements:~           Primary endpoint: Proportion of failure in both arms during the first 24 hours. Failure~          criteria: A raise of the Clinical score for respiratory distress (mWCAS) (1 point) or~          respiratory rate (10/min /H0 and above 60/min) or discomfort (EDIN) (1point /H0 and~          above 4) or apnea.~           Secondary outcomes: Assessment at H1, H12, H24 of mWCAS, respiratory and heart rate,~          EDIN score, skin lesions, FiO2 (fraction of inspired oxygen~           ) required to achieve an oxygen saturation between 94 and 97%, transcutaneous PCO2~          (carbon dioxide partial pressure) (correlated to an initial gas analysis), Report SpO2 /~          FiO2~        5. Statistic: Intention to treat Analysis. Expected number of patients: 71 per arm: 142~          children.~        6. Study Schedule: October 2014-April 2016~   "
84804|NCT02457000|"~     The purpose of this study is to explore the mechanisms behind how sleep quality may affect~     skin aging, skin integrity and skin disease.~   "
84805|NCT02456987|"~     This study is being conducted as a pilot to test the feasibility, usability, acceptability,~     and clinical utility of using a virtual reality (VR) immersion experience in the inpatient~     setting. In addition to determining whether the patients enjoy the experience and would like~     to participate in a future more tailored immersion in virtual reality, we will be attempting~     to determine whether there are any positive impacts on their visit, including a distraction~     from their pain or anxiety associated with their procedures or the reason they have been~     admitted to the hospital.~      Because the inpatient population at Cedars-Sinai Medical Center (CSMC) is dynamic and~     diagnostically diverse, we intend to develop a series of VR interventions that broadly~     address patient concerns. VR has only been tested in select patient populations, so we are~     equally interested in the feasibility of deploying VR across the inpatient hospital~     environment as we are in demonstrating some effectiveness in reducing pain and anxiety, and~     improving satisfaction.~      The present study has the following aims:~        1. Adapting existing VR environments for inpatients with a variety of impairments,~          utilizing cost-effective VR hardware (Phase 1).~        2. Assess the usability and acceptability of the VR equipment and software by hospital~          inpatients by conducting qualitative interviews (Phase 2).~        3. Assess the clinical utility of the VR intervention by measuring patient reported~          outcomes using a modified care satisfaction survey, administered to inpatients receiving~          VR and a matched control sample (Phase 3).~      Concerning Aims 2 and 3, we hypothesize the following:~        1. Inpatients will find the VR intervention helpful and enjoyable, and will believe that~          its benefits outweigh any difficulties encountered using the hardware or software.~        2. Inpatients who are exposed to the VR intervention will report significantly improved~          pain management, greater satisfaction with their inpatient visit, and greater overall~          health compared to matched control inpatients that were not exposed to VR.~   "
84806|NCT02456974|"~     Pharmacokinetics of antibiotics in critically ill neonates, infants and children~   "
84807|NCT02456961|"~     The standard CXL technique involves removal of the epithelium to enable riboflavin to~     penetrate into stromal tissue, to avoid epithelial debridement and increasing the patient's~     comfort and safety transepithelial corneal crosslinking (CXL) was suggested. Iontophoresis of~     riboflavin is one of approach for riboflavin impregnation.~      In this study, the investigators compared the results of standard corneal crosslinking (CXL)~     and transepithelial CXL via iontophoresis of riboflavin after 24 months follow up.~   "
84808|NCT02456948|"~     This study examines the antidepressant efficacy of minocycline as an adjunct to an~     antidepressant standard treatment with es-/citalopram, venlafaxine or mirtazapine monotherapy~     (AD-ST), for patients with unipolar major depressive disorder (MDD).~   "
84809|NCT02456935|"~     The purpose of this study is to demonstrate the efficacy of CJ-12420, once daily (QD),~     compared to esomeprazole in patients with erosive esophagitis classified as Los Angeles (LA)~     classification grades A to D at Week 8~   "
84810|NCT02456922|"~     The purpose of this study is to demonstrate the performance of the Harmony 1 Sensor in~     subjects age 2 - 75 years~   "
84811|NCT02456909|"~     To examine whether providing patients with a cue to the availability of pain medication~     affects patient satisfaction, patient anxiety, PCA efficacy, and safety.~   "
84812|NCT02456896|"~     The present study has been designed to evaluate the change in serum BDNF level with~     oxcarbazepine monotherapy in bipolar disorder and to explore the possibility of its~     neuroprotective effect.~   "
84813|NCT02456883|"~     The purpose of this study is to evaluate the pharmacokinetics of 14C-labeled gilteritinib, in~     particular, the routes of excretion and extent of metabolism of gilteritinib following~     administration of a single dose of 14C-labeled gilteritinib after repeated doses of~     gilteritinib.~      This study will also evaluate the safety of repeated oral administration of gilteritinib in~     subjects with advanced solid tumors as well as identify the metabolic profile of gilteritinib~     in plasma, urine and feces after a single oral dose of 14C-labeled gilteritinib.~   "
84814|NCT02456870|"~     The purpose of this pilot study is to determine whether adipose tissue loses some of its~     ability to expand in response to overfeeding in older compared to younger men. The~     investigators hypothesize that the adipose tissue response to overfeeding may be weakened in~     older when compared to younger men, thereby leading to worsened ectopic storage depots for~     older men.~   "
84815|NCT02456857|"~     The goal of this clinical research study is to learn if receiving 4 cycles of experimental~     chemotherapy before surgery can help to shrink the size of tumors in the breast and/or lymph~     nodes before they are removed through surgery. The safety of this combination will also be~     studied.~   "
84816|NCT02456844|"~     To study the Pharmacokinetics (PK) parameters of montelukast, flurbiprofen, midazolam,~     digoxin, pravastatin, and MTX when coadministered with BMS-986142.~   "
84817|NCT02456831|"~     This study evaluates the GI tolerance and acceptability of soy formulas fed to healthy term~     infants with reported intolerance to a milk-based formula.~   "
84818|NCT02456818|"~     This study aims to evaluate the impact of contact isolation on the rate of hospital-acquired~     transmissions of ESBL-producing Escherichia coli (ESBL-EC) and the rate of colonization and~     infection. On the basis of this study, it will be possible to re-evaluate the need for~     contact isolation for patients colonized or infected with ESBL-EC.~   "
84819|NCT02456805|"~     This study assessed tolerance improvement of a formula change in healthy term infants with~     perceived intolerance to their current milk-based formula feeding.~   "
84876|NCT02456064|"~     The purpose of this study is to determine whether a non-drug intensive program can help~     improve control of type 2 diabetes mellitus.~   "
84821|NCT02456779|"~     The primary objective of this clinical study is to determine whether Peptest (Human Pepsin~     lateral flow in vitro diagnostic medical device) is equivalent to other GERD diagnostic~     methods commonly applied in clinical practice by testing a large number of clinical samples.~      This will be performed by evaluating Peptest results in GERD patients (Erosive esophagitis or~     NERD), defined using standard clinical procedures, and compared to healthy controls.~   "
84822|NCT02456766|"~     This will be a multi-center, prospective, controlled study. It is expected that about 240~     subjects from 10 study centers will be enrolled, and 224 effective subjects will be~     statistically analyzed in the end, in which 56 effective subjects with stage F0 (25%), 56~     effective subjects with stage F1 (25%), 56 effective subjects with stage F2 (25%), 56~     effective subjects with stage F3 (25%). By comparison of the result of FibroTouch examination~     with that of liver biopsy, their specificities, sensitivities and accuracies for diagnosis of~     liver steatosis will be identified.~      The patients with liver diseases who need to have a liver biopsy in hospital and meet all of~     the inclusion criteria and none of the exclusion criteria, may participate in this study.~     Within two weeks of FibroTouch examination, subjects are required to have qualified~     histological specimens of liver biopsy for comparation.~   "
84823|NCT02456753|"~     The practice of ultrasounds increases in delivery rooms every year. Indeed, this method can~     help to visualize elements that may not be observable after clinical examination. Moreover,~     it is known that a fetal head engagement can lead to an instrumental extraction and in case~     of error, which happens in some cases, fetal and maternal risks are possible.~      These elements led to the investigators' hypothesis which is that a trans-perineal~     ultrasonography may facilitate the evaluation of a clinical fetal head engagement in case of~     doubt.~   "
84824|NCT02456740|"~     Randomized, stratified, double-blind, placebo-controlled, parallel-group, multi-center study~     followed by active-treatment phase. To evaluate the effect of AMG 334 compared to placebo on~     the change from baseline in monthly migraine days.~   "
84825|NCT02456727|"~     Chronic pain is a major public health problem that places many burdens on individuals,~     including impairment of physical and psychological functioning, lost productivity, and side~     effects of medications used to treat pain. There is also substantial evidence that minority~     populations differ both in prevalence and outcomes of chronic pain; access to care is a key~     component in these differences. Strong evidence now supports the use of acupuncture in the~     treatment of chronic pain conditions, including when provided in the primary care setting to~     patients from ethnically diverse, medically underserved populations. Acupuncture is slowly~     being integrated into pain management in many conventional health care settings, but cost and~     reimbursement for this service remain obstacles to offering acupuncture, especially in~     primary care and safety net settings. Because group acupuncture can be offered at much lower~     cost, demonstrating that individual and group delivery are equally effective could reduce~     barriers to use of this effective pain management approach.~      The primary aim of this study will be to evaluate whether acupuncture delivered in the group~     setting for patients with chronic pain is equal to acupuncture delivered in the individual~     setting. A secondary objective will be to use qualitative analysis to understand and describe~     the patient experience of both acupuncture approaches, and to utilize this data to inform~     intervention delivery and dissemination, to better incorporate the patient perspective.~   "
84826|NCT02456714|"~     Cholangiocarcinoma, is a malignant gastrointestinal tumor of low incidence with a poor~     prognosis. Chemotherapy is the most common treatment for advanced disease. On the basis of a~     phase III clinical study, cisplatin plus gemcitabine is considered standard first-line~     treatment in advanced cholangiocarcinoma patients, but there is no established second line~     therapy.~      Since fluorouracil and leucovorin combined with irinotecan and oxaliplatin (FOLFIRINOX)~     appears to be safe and demonstrated efficacy in clinical studies of advanced pancreatic~     cancer, colorectal cancer and a phase I study in cholangiocarcinoma, this combination could~     be an effective second-line treatment for patients with advanced cholangiocarcinoma.~   "
84827|NCT02456701|"~     This is a patient pilot study testing the hypothesis that vemurafenib with the addition of~     KTN3379 can restore iodine incorporation in BRAF mutant (MUT), radioiodine-refractory (RAIR)~     thyroid cancer patients.~   "
84828|NCT02456688|"~     This clinical research study will assess pharmacokinetics and the safety of Imrecoxib in~     patients with impaired hepatic function as compared to healthy volunteers.~   "
84829|NCT02456675|"~     A Phase 2, open-label study to evaluate the safety and efficacy of INCB040093 as monotherapy~     and as combination therapy with itacitinib (INCB039110) in subjects with relapsed or~     refractory Hodgkin Lymphoma.~   "
84830|NCT02456662|"~     Background/Purpose of the Study Doxycycline is an antibiotic used for infection prevention~     before surgical pregnancy termination, and a side effect of it is nausea/vomiting. The~     investigators' study explores whether or not taking the anti-emetic ondansetron prior to~     doxycycline decreases rates of nausea/vomiting. Patients enrolled in the investigators' study~     will take either ondansetron or a placebo before they take doxycycline to see if ondansetron~     decreases their nausea/vomiting. Reducing nausea/vomiting may prevent more infections, and~     decrease the rates of general anesthesia, patient risks and hospital costs. Decreasing~     nausea/vomiting will also improve patient experience.~      Study Design This will be a randomized controlled trial. Data will be collected by~     administrating surveys and a log where patients will record the timing of their medications~     and episodes of nausea/vomiting. The primary outcome is nausea/vomiting after taking the~     anti-emetic/placebo and doxycycline. 400 eligible patients will be enrolled over two years,~     200 in the intervention group and 200 in the placebo group.~      Rationale for Study Design A randomized controlled trial will be used to determine the~     effects of the anti-emetic ondansetron on rates of nausea/vomiting.~      Subject Characteristics Patients will be pregnant females, 18-45 years old, who are~     undergoing surgical termination of pregnancy.~      Design 1-2 days before the procedure, patients will complete a demographic questionnaire and~     a survey about symptoms of nausea/vomiting. They will use a log to record symptoms they~     experience between taking the anti-emetic/placebo and when they present for their procedure.~     When patients come to the hospital, they will fill out a repeat survey rating their~     nausea/vomiting.~   "
85015|NCT02454218|"~     tDCS can modify the attentional response of patients with fibromyalgia. Methods: This study~     deals with a randomized, blind, crossover, controlled tDCS-sham. The sample will consist of~     40 patients, divided into two groups with sham interventions and active crossover.~   "
84831|NCT02456649|"~     The combination of breast conserving surgery (lumpectomy) with radiation therapy has been~     shown to result in equivalent overall survival rates compared to mastectomy for the local~     treatment of breast cancer. As a result, the majority of patients diagnosed with breast~     cancer in the United States undergo lumpectomy as their primary surgical therapy. Multiple~     studies have demonstrated the association between positive lumpectomy margins and an~     increased risk of ipsilateral breast tumor recurrence, even with postoperative radiation.~     Studies report 20-40% of lumpectomy procedures result in one or more involved (positive)~     surgical margins, leading to the need for further surgery, emotional distress, poorer~     cosmesis, delay to adjuvant treatments, and increased cost. Current available intraoperative~     margin assessment techniques include specimen Xray, gross pathology, frozen section, and~     touch prep cytology. To reduce the incidence of positive margins, the MarginProbe (Dune~     Medical Devices, Caesarea, Israel) was developed to provide real-time, intraoperative~     assessment of the presence of tumor at the lumpectomy margin. In the current study, the~     investigators aim to determine the effectiveness of MarginProbe as an adjunctive tool to~     standard practice for intraoperative identification of tumor at lumpectomy margins, and its~     ability to reduce positive margins and decrease the need for additional surgical procedures.~   "
84832|NCT02456636|"~     The purpose of this study is to compare three methods for managing obesity in rural patients,~     to see which method will result in patients being able to attain their weight loss goal and~     maintain that weight loss.~   "
84833|NCT02456623|"~     The purpose of this study is to preliminarily validate a parent-focused obesity intervention~     program for parents of low-income, African American preschoolers who are currently overweight~     (> 85th BMI %tile). Half of the participants will receive an intervention that is eight~     sessions in length and carried out in the participant's home. The sessions will target the~     nutrition and physical activity knowledge of parents and their motivation for changing~     parenting related to family eating habits and activity level. The remaining participants will~     receive an attention comparison control condition (ACCC), which includes one home visit, 7~     newsletters and 4 monthly support phone calls. It is hypothesized that children of parents~     receiving the intervention will have decreases in BMI %tile, consume more fruits/vegetables~     and fewer sugary beverages, and engage in more activity as compared to ACCC.~   "
84834|NCT02456610|"~     Cytomegalovirus (CMV) and Epstein Barr Virus (EBV) cause significant morbidity and mortality~     in hematopoietic stem cell transplantation (HSCT) patients in China. Antiviral drugs given~     either prophylactically or as early therapy for patients with detectable viral loads appear~     to be an effective strategy for reducing viral infections. However, long-term treatment with~     these drugs is associated with significant toxicity, expense and the appearance of drug~     resistant virus isolates ultimately resulting in treatment failure. CMV and EBV specific T~     cells infusion to immunocompromised patients following HSCT is able to induce a successful~     anti-viral response. The primary purpose of this study is to determine the safety and~     efficacy of the infusion of CMV and EBV specific cytotoxic T cells (CTLs) for patients with~     CMV and EBV reactivation or infection.~   "
84835|NCT02456597|"~     To investigate the function of a novel catheter for continuous peripheral nerve blocks in the~     popliteal nerve: Two key issues are investigated 1) Successful primary placement and function~     of the catheter for continuous peripheral nerve blocks confirmed by a decrease in motor~     function following injection of local analgesics through the catheter; 2) The rate of~     displacement after standardized movement of the limb where the catheter for continuous~     peripheral nerve blocks is inserted.~   "
84836|NCT02456584|"~     This is a randomized, multi-center, parallel-group Phase I study to evaluate the~     pharmacodynamics (PD) of Medroxyprogesterone Acetate (MPA) after a single subcutaneous (SC)~     injection of 150 mg/mL or 300 mg/2 mL Depo-Provera CI in the abdomen of women of reproductive~     age with a confirmed ovulatory baseline cycle.~   "
84837|NCT02456571|"~     This pilot study will explore the prevalence of expression of four immune checkpoint~     biomarkers on circulating tumor cells (CTCs) from men with metastatic prostate cancer that~     are captured by EpCAM via the CellSearch method, and specifically defined as co expressing~     DAPI and cytokeratin, and lacking CD45 expression.~   "
84838|NCT02456558|"~     This study will evaluate the safety, tolerability, antiretroviral activity, pharmacokinetics,~     and pharmacodynamics of an intravenous formulation of deferiprone in HIV-infected subjects.~   "
84839|NCT02456545|"~     Prospective multicentre observational study for treatment approaches in at-risk individuals.~     Furthermore the purpose of this study is to test feasibility of a clinical staging model and~     validate diagnostic tools to identify individuals at risk state for the development of BD.~   "
84840|NCT02456532|"~     This proposal will assess risks for transition from therapeutic hypnotic use to abuse in~     people with insomnia. The investigators will study a hypothesized at-risk sub-population,~     insomniacs with hyperarousal, and compare two hypnotics, a drug with mood effects,~     eszopiclone, versus one without mood effects, zolpidem.~   "
84841|NCT02456519|"~     Provision of high-quality anaesthesia is a fundamental goal of all anaesthetic services.~     Establishing whether this is being achieved requires validated measures of anaesthetic~     outcomes but few of these exist, particularly for children.~      QoR-15 (quality of recovery, 15 items) is a questionnaire that has been validated in adults~     and assesses the quality of postoperative recovery from surgery. The investigators have~     developed a modified version, the PaedQoR-15, that the investigators hope is capable of~     performing the same task in children and young people. The principle aim of this study is to~     assess whether PaedQoR-15 is a valid, reliable and clinically acceptable measure of the~     quality of postoperative recovery in children and young people.~      The investigators would also like to consider whether parent/guardian assessments of their~     child's recovery correlate with self-reports. At Great Ormond Street a significant proportion~     of children are unable to answer for themselves. If parent/guardian responses represent a~     good approximation then this questionnaire may have a role in assessing the quality of~     recovery in a population of children who are difficult to care for.~   "
84842|NCT02456506|"~     This study evaluates the hyperfractionated IMRT in the treatment of patients with locally~     recurrent nasopharyngeal carcinoma. Half of participants will receive hyperfractionated IMRT,~     while the other half will receive conventional fraction IMRT.~   "
85048|NCT02453789|"~     The purpose of the study is to assess the efficacy of Alginate oligosaccharide (OligoG) dry~     powder for inhalation in cystic fibrosis (CF) patients with a Burkholderia spp. infection.~   "
84843|NCT02456493|"~     The patients who have undergone cardiac surgery have higher likelihood of postoperative~     cognitive dysfunction (POCD). The carotid intima-media thickness (IMT) is associated with~     cognitive dysfunction in the old. The aim of this study is to evaluate the effect of carotid~     IMT in patients undergoing OPCAB(off-pump coronary artery bypass surgery) on postoperative~     cognitive dysfunction. Two hundred twenty four patients, aged 20 to 79 years, scheduled for~     OPCAB will be divided into increased IMT (n=112) and normal IMT (n=112) group by preoperative~     B-mode ultrasonography. The cognitive function measured by K-MMSE, MOCA-K before the~     operation, and on the 7 day, 3 months after operation. The patients in the non-surgical group~     are measured three times: baseline, after 7days, after 3 months.~   "
84844|NCT02456480|"~     To assess the pharmacodynamics, safety/tolerability, and efficacy of omiganan in patients~     with mild to moderate atopic dermatitis (AD).~   "
84845|NCT02456467|"~     This study compares the results of current standard coagulation measurement devices to the~     Quantra System, a new device, using small amount of extra blood obtained during routine blood~     draws in cardiac surgery patients.~   "
84846|NCT02456454|"~     Controlled trial of the efficacy and safety of valproate, versus risperidone in children,~     ages 3-7 yr. with Bipolar I or II Disorder, mixed, manic or hypomanic episode.~   "
84847|NCT02456441|"~     The International Continence Society (ICS) defines overactive bladder ( OAB) as a clinical~     syndrome characterized by urgency with or without urge incontinence , usually accompanied by~     frequency and nocturia , since in the absence of proven infection or other pathology related~     . The negative impact on quality of life of patients with OAB is already known. The etiology~     and pathophysiology of OAB are not completely understood. However, studies indicate an~     alteration of sympathetic and parasympathetic nerve stimulation involved in the mechanism of~     OAB. A Transcutaneous Electrical stimulation of the Tibial Nerve ( TENS) has been studied as~     a noninvasive and inexpensive , treating the symptoms of this syndrome therapeutic way .~     However, no studies in the literature evaluating the effect of electroconvulsive therapy on~     the mechanisms involved in sympathetic and parasympathetic modulation in these women . The~     objective of this study is to investigate the effects of TENS on the sympathetic and~     parasympathetic system in women with OAB . This is a randomized, double -blind , which will~     be assessed , first, in a pilot study , 30 female patients with OAB randomly allocated into 2~     groups : TENS group and placebo group. Interventions take place in one day assessment of the~     sympathetic and parasympathetic nervous system are performed . After collecting the data will~     be analyzed in accordance with the statistical analysis.~   "
84848|NCT02456428|"~     The purpose of this study is to determine whether incretin-based drugs (used to treat type 2~     diabetes) taken either alone or in combination with other anti-diabetic drugs are associated~     with an increased risk of heart failure (HF) compared to other combinations of oral~     hypoglycemic agents (OHA).~      The investigators will carry out separate population based cohort studies using~     administrative health databases in six jurisdictions in Canada, the US and the UK. Cohorts~     will be defined by the initiation of a new anti-diabetic drug when incretin-based drugs~     entered the market, with follow-up until hospitalization for HF. Analyses will be done~     separately for groups of patients with and without prior HF. The results from the separate~     sites will be combined to provide an overall assessment of the risk of HF in users of~     incretin-based drugs and by class of incretin-based drugs.~   "
84849|NCT02456415|"~     This study evaluates the safety and efficacy of biodegradable magnesium alloy screw, in~     patients with hand fractures who require internal fixation (to obtain a product license from~     the Ministry of Food and Drug Safety in Korea (MFDS)).~   "
84850|NCT02456402|"~     This randomized trial will assess the efficacy of Drug Coated Balloon (DCB) compared to Bare~     Metal Stent (BMS) using Fractional Flow Reserve (FFR) guidance for de novo coronary artery~     lesions in patients unable to tolerate dual antiplatelet therapy and at high risk of~     bleeding. Patients will be randomized after balloon angioplasty to receive either DCB or BMS.~     Endpoints are late luminal loss at 9 months, and major adverse cardiac events including~     arterial thrombosis at 1, 9 and 12 months.~   "
84851|NCT02456389|"~     The primary objective of this trial is to determine if perioperative risk stratification and~     risk-based, protocol-driven management leads to a reduction in the rate of death or serious~     complications compared to standard perioperative management in patients undergoing elective~     major cancer surgery.~   "
84852|NCT02456376|"~     The purpose of this study is to investigate how sensory information processing affects~     balance ability in children with cerebral palsy (CP). An additional goal is to determine if a~     subsensory electrical stimulation called Stochastic Resonance (SR) Stimulation, can improve~     balance in children with CP. Children with CP and children with typical development will~     participate and complete a series of clinical and balance assessments. They will also be~     tested in a sensor fusion paradigm to investigate potential deficits in the dynamic~     integration of visual, vestibular and proprioceptive information during upright stance. SR~     stimulation will then be used to potentially improve these deficits and subsequently their~     balance ability.~   "
84853|NCT02456363|"~     Assessed using (1) Adalimumab(Humira) and NSAIDs (2) Use only Adalimumab(Humira) treatment of~     ankylosing spondylitis patient safety and efficacy.~   "
84861|NCT02456259|"~     The number of patients undergoing Minimally Invasive Cardiac Surgery (MICS) is increasing~     each year. MICS procedures on atrioventricular valves are usually performed without~     conventional sternotomy, an alternative approach is from right anterolateral minithoracotomy.~     This surgical approach has essential impact both on anesthesia techniques and cardiopulmonary~     bypass (CPB) settings. Specific anesthesiological procedure is an insertion of neck venous~     cannula of CPB through the right internal jugular vein into the superior vena cava both for~     partial and total bypass. The size of neck cannula is between 15 and 21 French depending on~     the type of surgical procedure and patient's weight. Central venous catheter and eventually~     sheath are also inserted into the right internal jugular vein. Thus, there is a relevant~     question regarding postoperative patency of right internal jugular vein in patients~     undergoing MICS procedures requiring an insertion of neck cannula of CPB. The investigators~     hypothesize, there is no significant difference in postoperative patency of internal jugular~     vein assessed by ultrasound in patient undergoing cardiac surgery with and without neck~     cannula of CPB~   "
84854|NCT02456350|"~     Autologous T cells engineered to express an anti-CD19 chimeric antigen receptor (CAR) with a~     safety switch will be infused back to patients with B cell malignancies, including lymphoma~     and leukemia. The patients will be monitored after infusion of anti-CD19 CAR-transduced T~     cells for adverse events, persistence of anti-CD19 CAR-transduced T cells and treatment~     efficacy.~      Objectives:~      To evaluate the safety and the efficacy of anti-CD19 CAR-transduced T cell therapy for~     patients with B cell malignancies.~      Eligibility:~      Patients between 1 and 85 years of age, who have relapsed or refractory CD19-expressing~     B-cell malignancies (leukemia or lymphoma) that have not responded to standard treatments.~      Patients with a history of allogeneic stem cell transplant who meet all eligibility criteria~     are eligible to participate.~      Patients must have adequate organ functions.~      Design:~        -  Peripheral blood from patients will be collected for isolation of peripheral blood~          mononuclear cells (PBMCs), which will be transduced with a lentiviral or retroviral~          vector encoding anti-CD19 CAR containing a CD28 and a CD3 zeta as costimulatory domains~          as well as a safety switch.~        -  Patients will receive a lymphodepleting preconditioning regimen to prepare their immune~          system to accept modified T cells.~        -  Patients will receive an infusion of their own modified T cells. They will remain in the~          hospital to be monitored for adverse events until they have recovered from the~          treatment.~        -  Patients will have frequent follow-up visits to monitor the persistence of modified T~          cells and efficacy of the treatment.~   "
84855|NCT02456337|"~     The purpose of this study is to evaluate the reduction of gingival recession of single Miller~     Class I and II defects treated by coronally advanced flap with subepithelial porcine collagen~     matrix graft and / or enamel matrix proteins.~   "
84856|NCT02456324|"~     The study is designed as a prospective, non-randomized clinical trial comparing safety and~     effectiveness of the CuraSeal PICS-AF device to historical data from commercially available~     devices for the treatment of anorectal fistulas.~   "
84857|NCT02456311|"~     VATS anatomical lung resection provides an effective minimally invasive treatment strategy~     for stage I and II lung cancer. VATS lobectomy is associated with significantly less~     postoperative atrial fibrillation, blood transfusion, renal failure, and other complications~     when compared with lobectomy via thoracotomy.~      Although VATS lobectomy has been proven to be effective and safe in experienced hands, it is~     not devoid of risk. Intra-operative surgical complications can be at times catastrophic.~     Complications include: pulmonary vascular injuries (PA, pulmonary vein) necessitating urgent~     conversion to open thoracotomy and even death14. Causes of conversion included PA injury,~     difficult anatomy, bulky/calcified lymph nodes, and technical problems including stapler~     misfire. PA injury alone constituted 37.5% of all conversions. Proper dissection of all~     tissue around PA branches is sometime difficult especially in the presence of adhesions or~     large, calcified lymph nodes and may increase the risk of vascular injury.~      Currently, in spite of being a safe and effective technique in experienced hands, a minority~     of anatomical pulmonary resections are being performed by VATS. In an analysis utilizing the~     Nationwide Inpatient Sample (NIS) database in the United States, only 15% of anatomical lung~     resections were performed by VATS.~      The technical difficulty and danger of VATS lobectomy is directly related to PA branch~     manipulation, stapling and division. PA manipulation is the main hesitation of many thoracic~     surgeons regarding the adoption of VATS lobectomy. The investigators believe that by~     decreasing the manipulation and dissection required by the surgeon on the PA branches, these~     procedures will be safe and therefore more prevalent for anatomical pulmonary resections.~   "
84858|NCT02456298|"~     The main purpose of this study is to determine the most efficient way for families to reduce~     problem behavior in their children with an autism spectrum disorder. Parents will be trained~     using telehealth to use applied behavior analysis (ABA) procedures to improve child behavior~     and communication. The study compares an established type of ABA assessment and treatment to~     a briefer, more streamlined version of this same type of assessment/treatment.~   "
84859|NCT02456285|"~     Background When first diagnosed, colorectal cancer has already metastasized in about 20% of~     patients to the liver or further (termed synchronous disease). For patients with metastatic~     disease limited to the liver, major surgery to resect both the primary colorectal cancer and~     the liver metastasis provides 5-year survival rates of 25-40%.~      Conventional surgery removes the colorectal primary first, followed by adjuvant chemotherapy,~     and then resection of the liver metastasis. Surgical advances make synchronous resection~     (removing both primary and liver metastasis together) and liver-first resection possible.~      Currently, there is no conclusive evidence to show which approach improves morbidity or~     survival, and therefore there is no optimum clinical pathway. Treatment is decided at~     multidisciplinary team (MDT) meetings and is dependent on multiple factors: cancer staging,~     patient health and preferences, and clinical experience.~      Methods Colorectal cancer with Synchronous liver-limited hepatic Metastasis: an Inception~     Cohort (CoSMIC), will consent and recruit patients with a new diagnosis of synchronous~     colorectal cancer limited to the liver.~      Patients will be recruited at Manchester Royal Infirmary (a National Health Service (NHS)~     regional cancer-network approved Hepato-pancreato-biliary specialist centers over 2 years~     using standardized data collection. The sequence of treatment received by each patient, and~     factors influencing treatment decisions, will be recorded and evaluated against European~     Society of Medical Oncology guidelines. The effect of surgery on patient quality of life,~     morbidity, mortality and the long-term outcome will be measured and compared for different~     treatment sequences adjusted for prognostic factors.~      Anticipated Outputs and Value of Findings Direct comparison of conventional and new surgical~     sequences will be explored. Patient engagement, use of standardised recording, identifying~     common clinical patterns and decision making, and understanding sources of variation are~     essential steps to develop a definite randomized control trial to resolve the optimal~     clinical pathway.~   "
84860|NCT02456272|"~     This is a French pilot study in the Toulouse University Hospital that will include a minimum~     of 30 patients with proven unilateral or asymmetric otosclerosis. Each one will receive a~     hearing aid for a minimum of 2 months and then undergo otosclerosis surgery.~   "
84862|NCT02456246|"~     Stereotactic body radiotherapy (SBRT) has emerged as one of the leading curative method for~     early stage non-small cell lung cancer (NSCLC). However, assessing the status of the disease~     during post-SBRT follow up presents a challenge. Currently, chest Computed Tomography (CT) is~     the main technique to detect whether cancer has come back, but this method has demonstrated~     poor accuracy and reliability in determining if the observed post-operative lung changes are~     benign or malignant.~      Positron-emission tomography (PET) is an imaging technique that uses special radioactive~     tracers to cell growth. The use of PET scans with a tracer that target the pathways of DNA~     synthesis may be more accurate than CT for detecting if the cancer has come or not.~      The purpose of this study is to see if a PET radiotracer called 18F-FLT~     (3'-deoxy-3'-fluorothymidine) can identify cancer recurrences accurately compared to regular~     CT scans.~   "
84864|NCT02456220|"~     The aim of the study is to perform a three-dimensional (3D) evaluation of the dentoskeletal~     changes in pubertal Class II malocclusion subjects treated with the Herbst appliance (HAG),~     in comparison with a Class II comparison group (CG). 3D virtual models generated from three~     time-point CBCTs (T0, baseline; T1, immediately after Herbst insertion; and T2, 8 months~     after) of 25 HAG patients will be evaluated. Virtual models obtained from 25 Class II~     malocclusion patients, in the same stage of biologic maturation and skeletal abnormality, but~     with no orthopedic treatment will be constructed for the CG subjects. These CG patients are~     under orthodontic treatment, but only with teeth alignment. Voxel based registration on the~     anterior cranial fossa will be used to assess maxillary and mandibular displacement/articular~     fossa remodeling; regional registration on the mandibular corpus will be performed to~     evaluate mandibular growth and mandibular dental changes; and regional registration on the~     anterior region of the maxilla will be performed to evaluate maxillary growth and maxillary~     dental changes.~   "
84865|NCT02456207|"~     The primary objective of the study is to assess the pharmacokinetic (PK) similarity of SCT400~     versus rituximab (MabThera®) in patients with CD20+ B-cell Non-Hodgkin's Lymphoma.~      The secondary objective of the study is to evaluate the pharmacodynamics (PD) and safety of~     SCT400 versus rituximab (MabThera®), as well as the presence of human anti-chimeric~     antibodies (HACA).~   "
84866|NCT02456194|"~     This is a prospective clinical trial of tibial plateau fractures treated with internal~     fixation and a calcium sulfate graft which can be mixed with antibiotics and molded into~     various bead sizes for implantation into bone defects. The graft material chosen for this~     study is STIMULAN Rapid Cure (Biocomposites, UK), which is approved for use as a bone void~     filler and may be mixed with a variety of antibiotics. The combination of STIMULAN +~     antibiotic in bead form is the study device.~      Our primary study aim is to look at resorption and remodeling of the study device into bone.~     Another important aim of the study is to look at subsidence, or collapse, of the joint~     surface.~   "
84867|NCT02456181|"~     The overall aim of the proposed project is to test the efficacy of a relatively new,~     well-developed math program on the math achievement of elementary school students in~     mainstream classes in urban schools. Use of this program is increasing in Canada and the~     United Kingdom. Preliminary findings derived from uncontrolled trials and our own pilot,~     randomized controlled trial suggest it may yield meaningful gains in math achievement for~     both at-risk and achieving students, as indexed by their performance on national exams, in~     national math competitions, as well as on standardized measures of math achievement. However,~     the program has yet to be rigorously evaluated to determine its relative efficacy compared to~     the math programs typically used by school boards. The program provision of grade-specific~     teacher's guides and student workbooks (for grades 1 to 8), and minimal teacher training,~     points to its potential utility for full-scale implementation, should its efficacy be~     confirmed.~   "
84868|NCT02456168|"~     Cognitive impairment occurs in as many as 80% of lupus patients and affective disorders,~     depression and anxiety, are also common. Both of these problems contribute significantly to~     disease burden and disability. Associations between serum anti-NMDAR Aab and cognitive and~     behavioral changes in human SLE have remained controversial, however, elevated titers of~     these Aabs in cerebrospinal fluid (CSF) correlate with severe central nervous system~     manifestations, such as coma and psychosis. The aim is to study the progression of disease~     (cognitive and behavioral impairment) over a 2 year period in SLE subjects with~     neuropsychologic and behavioral testing and correlates of disease progression using resting~     FDG-PET and serum Anti-NMDAR Aab. The correlations between hippocampal hypermetabolism,~     Anti-NMDAR Aab and memory impairment observed in the cross-sectional studies will be~     validated by baseline measurements in the proposed studies.~   "
84869|NCT02456155|"~     The investigators assessed the utility of ultrasonography in confirming the position of nasal~     jejunal tube after bedside placement when compared with endoscopic placement in patients with~     severe acute pancreatitis.~      Primary endpoint:~      Success rate.~      Secondary Endpoint:~      Adverse effects, Change of intra-abdominal pressure (1h before, 1h after and 3 days after~     placement), Tolerance of enteral nutrition, Time to approach the target calories.~   "
84870|NCT02456142|"~     Pain is a subjective sensation which in children can only be experienced and most times not~     expressed. Pain management in children thus falls short of their adult counterparts. Acute~     pain of surgery causes significant suffering and stress. In children, pain management has~     lagged behind because of the belief that children's pain receptors are less well developed~     than their adult counterparts. However this has been proven to be false as development of~     pain receptors has been shown by 26th week of gestation. Caudal analgesia with plain~     bupivacaine has been used for effective post operative analgesia. Resources sometimes limit~     acquisition of additives to bupivacaine to be delivered into the intrathecal space.~      The fear of pharmacological adverse effects of opioids has restricted their use especially~     among the anesthesia officers who deliver the bulk of anesthesia services in Uganda and this~     has led to poor pain management in pediatric populations Mulago national referral hospital is~     a resource limited centre with regards to human resource, equipment and drugs. This is mainly~     due to lack of sufficient funds and large volume of patients with the nursing staff being~     overwhelmed by the patient capacity. Drug administration is often not done on time and~     continuous assessment of pain scores in children is not adequate resulting in poor post~     operative pain management. Pain control thus will depend on analgesia provided at the time of~     operation creating a need for prolonged pain control measures.~      Studies done have compared intravenous morphine administration versus caudal analgesia and~     are mostly focused of sub umbilical surgery however none has been done in our setting.~     Bupivacaine and morphine are now more readily available and can be used for post operative~     analgesia. However studies on the timing to the next analgesic requirement have not been~     compared/done in Mulago national referral hospital.~   "
84871|NCT02456129|"~     This is a study in postmenopausal women to investigate the Drug-drug interaction (DDI)~     between itraconazole(ITZ) and orally administered vilaprisan; absolute bioavailability using~     intravenous microtracer dose of [14C]vilaprisan.~   "
84872|NCT02456116|"~     The purpose of this study is to evaluate the use of needle acupuncture in comparison to a~     conventional postoperative pain management in terms of reducing pain and pain medication use~     in an interdisciplinary setting in a controlled, randomized study design after implantation~     of total knee arthroplasty .~   "
84873|NCT02456103|"~     This is an open-label extension study for patients who complete a Phase 3, placebo-controlled~     study of ataluren in patients with nonsense mutation cystic fibrosis (nmCF) not receiving~     chronic inhaled aminoglycosides.~   "
84874|NCT02456090|"~     The purpose of the PaTH Clinical Data Research Network (CDRN) Study of Healthy Lifestyles,~     Body Weight and Health Care is to use clinical data from electronic health records (EHR) and~     patient reported outcomes (PRO) to answer questions of clinical importance to patients,~     providers, and other stakeholders.~   "
84877|NCT02456051|"~     Pancreatic Cancer is a leading cause of cancer-related death. To date, only one fifth of~     patients at diagnosis is presented resectable because the diagnosis is often delayed making~     the 5-year survival of this disease globally less than 5%. An early diagnosis in these~     patients is currently not possible given the economic disadvantages of a population-wide~     screening. New evidences identify patients with new-onset diabetes as a subgroup of patients~     at high risk of developing this disease (RR 5:38). In a subset of these patients a mediator~     secreted by the tumor, the Adrenomedullin, could be responsible for the onset of diabetes.~     Our goal is therefore to assess the different impact of Pancreatic Cancer depending on~     Adrenomedullin values in patients with newly diagnosed diabetes mellitus.~   "
84878|NCT02456038|"~     The aim of this study is to assess safety and efficacy of Asfotase Alfa (ALXN1215) in~     patients with hypophosphatasia~   "
84879|NCT02456025|"~     The main aim of this study is to evaluate the efficacy and safety of topical tacrolimus 0.01%~     eyedrops in patients with vernal keratoconjunctivitis.~   "
84880|NCT02456012|"~     The purpose of this study is to determine whether a long-term prophylactic use of~     esomeprazole 20 mg twice daily or once daily has prevention effectiveness in reducing the~     recurrence of peptic ulcer bleeding after ulcer healed with 16-week oral esomeprazole therapy~     in high-risk patients whose Rockall score ≥ 6.~   "
84881|NCT02455999|"~     The aim of this pilot study is to compare the analgesic effect of two strengths of SYL1001~     eye drops versus placebo in patients with ocular pain associated with Dry Eye Syndrome.~     General and local tolerability are also evaluated.~   "
84882|NCT02455986|"~     A school based pedometer competition among Year 9 pupils (12 - 14 years old) to promote~     physical activity (PA).~   "
84883|NCT02455973|"~     This study is a randomized clinical trial with two interventions: control group and~     intervention interdisciplinary group, without cross-over.~      Control Group (CG): In this type of intervention, the focus will be the development of skills~     through educational activities on health using the pedagogy of transmission.~      Interdisciplinary Intervention Group (IG): In this type of intervention, the focus will be~     the development of skills through educational activities on health that provide the~     development of autonomy and empowerment for behavior change, based on interdisciplinary~     motivational strategies. All topics will be focused on the major cardiovascular risk factors~     considered modifiable.~      The staff is trained to the techniques of motivational interviewing and transtheoretical~     model of change and the health issues related to the modification of lifestyle.~      So this interdisciplinary intervention with adolescents seeks to measure the result of an~     educational proposal using the techniques of motivational interviewing and transtheoretical~     model of change, for all professionals involved independent training in health issues related~     approach to lifestyle modification and the inclusion of family in this process.~   "
84884|NCT02455960|"~     This trial was performed to examine the efficacy of oral L-arginine for preventing CI-AKI in~     chronic kidney disease (CKD) patients.~   "
84885|NCT02455947|"~     The purpose of this study is to investigate the effect of Inquiry based stress reduction~     (IBSR) meditation technique on levels of burnout and wellbeing among teachers.~   "
84886|NCT02455934|"~     Randomized, double-blind, crossover-trial, 30 subjects in each groups, either males or~     females, normal fasting glucose or pre-diabetes, aged > 18 years old to perform oral sucrose~     tolerance with either one of the 5 study products~        1. Sucrose 50 g~        2. Sucrose 50 g + D-allulose (psicose) 2.5 g~        3. Sucrose 50 g + D-allulose (psicose) 5 g~        4. Sucrose 50 g + D-allulose (psicose) 7.5 g~        5. Sucrose 50 g + D-allulose (psicose) 10 g~      Primary endpoints:~        1. To investigate the dose-response effects of D- allulose (psicose) with sucrose beverage~          on glucose tolerance~        2. To investigate the dose-response effects of D- allulose (psicose) with sucrose beverage~          on insulin levels~   "
84887|NCT02455921|"~     The aim of this prospective randomized study is to investigate comparatively the effect of~     neostigmine-atropine versus sugammadex on speed and quality of recovery and on postoperative~     cognitive function & behavior in children undergoing ENT surgery under general anaesthesia.~   "
84888|NCT02455908|"~     The aim of the study is to design an open-label phase 1-2 trial to assess safety and clinical~     and immunologic effects of repeated administration of recombinant low dose IL2 (Proleukin) in~     5 patients with idiopathic nephrotic syndrome unresponsive to drugs (steroids, calcineurin~     inhibitors, Rituximab), following the therapeutical scheme indicated for crioglobulinemic~     nephropathy:~      cycle1: IL2 1x106 /m2 s.c for 5 consecutive days cycle2: IL2 1.5 x106 / m2 s.c for 5~     consecutive days, starting from 3 weeks after the first cycle.~      cycle3: IL2 1.5 x106 /m2 s.c for 5 consecutive days, starting from 6 weeks after the first~     cycle.~      Cycle 4: IL2 1.5 x106 /m2 s.c for 5 consecutive days, starting from 9 weeks after the first~     cycle.~      Current therapy with steroids and calcineurin inhibitors (Prograf) will be maintained during~     the first cycle and progressively reduced during the subsequent cycles.~      The first cycle will be performed during hospitalization in the investigators Unit;~     subsequent cycles will be performed at nephrology outpatients. All laboratory values normally~     utilized in the follow up of patients affected by idiopathic nephrotic syndrome will be~     evaluated during the first week of treatment and at the end of the protocol, together with~     specific cellular values (Tregs, B cells, NK).~   "
84889|NCT02455895|"~     This study is designed to evaluate the effect of Novabay iLid Cleanser, as compared to its~     Vehicle, on the ocular skin flora.~      In the pre-randomization phase, subjects will receive a single application of open-label~     NovaBay iLid Cleanser.~      In the randomization phase of Stages 1 and 2, subjects will self-treat with masked~     Investigational Product twice daily for ten (10) days.~   "
84907|NCT02455661|"~     FERARI is a single centre observational study comparing patients undergoing PCI either using~     radial compression devices or femoral closure devices at the corresponding access site.~      First primary outcomes consist of the occurrence of vascular complications at the arterial~     access site including major bleedings as defined by common classification systems~      Second primary outcomes consist of the occurrence of adverse cardiac events including~     all-cause mortality, target lesion and vessel revascularization (TLR and TVR) during 30 days~     and 12 months of follow-up.~   "
85070|NCT02453490|"~     This study is a multicenter ,randomization, open control study to evaluate the efficacy and~     safety of Raltitrexed-based chemotherapy and 5-fluorouracil-based chemotherapy in the~     peri-operative treatment of patients with Liver Metastasis From colorectal cancer (CRC).~   "
84890|NCT02455882|"~     Through the investigators' Breast Care Center at the University of Michigan Comprehensive~     Cancer Center, the investigators treat approximately 75 patients per year with neoadjuvant~     chemotherapy. The majority of the remainder of patients with stage II and III disease undergo~     treatment with adjuvant chemotherapy either on a clinical protocol or as standard of care.~     There is a subset of women with ER positive disease who do not receive chemotherapy because~     of favorable tumor characteristics.~      This tissue procurement protocol is designed to systematically collect tissue, urine and~     blood specimens on patients undergoing neoadjuvant systemic therapy or adjuvant chemotherapy,~     serially following treatment, and/or at the time of disease recurrence in order to~     investigate mechanisms underlying development of metastatic disease, to identify predictors~     of response and resistance to therapy, and to test potential new therapies for breast cancer~     using a combination of patient-derived xenograft creation and new microfluidic technologies.~   "
84891|NCT02455869|"~     The present study is designed as a single-centre, randomized, controlled clinical trial to~     evaluate and compare the clinical efficacy of two local drug delivery systems containing 1%~     ALN gel and 1.2% ATV gel in treatment of intrabony defects in patients with chronic~     periodontitis as an adjunct to SRP.~   "
84892|NCT02455856|"~     The purpose of this study is to assess the effects of repeated once daily administration of~     200 milligram (mg) of itraconazole (steady state) on the single-dose pharmacokinetics of JNJ~     42847922 in healthy, male participants.~   "
84893|NCT02455843|"~     This study is a multicenter, randomized, open-label Phase III trial that compares microwave~     plus chemotherapy versus chemotherapy in patients with advanced non-small cell lung cancer.~     The primary endpoint is progression free survival (PFS) and the key secondary endpoint is~     overall survival (OS). A total of 275 eligible patients will be randomized to receive either~     microwave ablation combinated with first-line platinum-based doublet chemotherapy（138） or~     first-line platinum-based doublet chemotherapy（137） in a 1:1 ratio until patients. The~     response of microwave ablation will be assessed by the expert consensus for thermal ablation~     of primary and metastatic lung tumors. Tumor response and progression will be assessed~     according to Response Evaluation Criteria in Solid Tumors（RECIST）1.1.~   "
84894|NCT02455830|"~     This is a observational study to assess the effects of and to explore the mechanisms of~     autologous umbilical cord blood cell therapy for neonatal encephalopathy by way of measuring~     serum cytokines.~   "
84895|NCT02455817|"~     Single center, retrospective registry to collect data regarding the rate of angina (any and~     CCS clas III/IV) within 12 months post stent implantation. In addition, the target vessel~     revascularization rate within 12 months post stent implantation.~   "
84896|NCT02455804|"~     This is a prospective, post-marketing, non-randomized, multi-center, single-arm clinical~     study that will be conducted at up to 15 sites in the United States (US). All subjects will~     be treated with the NIRxcell Stent System and followed at 30 days, 9 months and 1, 2 and 3~     years post-index stenting procedure. An unscheduled follow up may be conducted as clinically~     warranted.~   "
84897|NCT02455791|"~     The goal of this clinical research study is to compare the use of an ultrasound-guided biopsy~     with what is found during surgery in finding evidence of the disease.~   "
84898|NCT02455778|"~     This double blind placebo control study with supplementation of oral Cinnamon is being~     conducted to test the hypothesis that in subjects with Metabolic Syndrome oral cinnamon may~     lead to improvement in body composition and metabolic parameters.~   "
84899|NCT02455765|"~     The study will investigate if consumption of amino acid mixtures results a change in glycemic~     response of carbohydrate (white rice) and insulinemic response at different doses and timing~     (before consumption of carbohydrate).~   "
84900|NCT02455752|"~     The study involves the use of Retroperitoneal plane for TME for rectal anterior resection.~     Through a pilot prospective study, LR-TME will be assessed as one arm study.~   "
84901|NCT02455739|"~     The investigators aimed to assess whether postoperative gum chewing improve intestinal~     functions.~   "
84902|NCT02455726|"~     Magnesium exerts analgesic effects in several animal pain models and in patients affected by~     acute postoperative pain and chronic pain of neuropathic origin. There is no evidence that~     magnesium can modulate pain in patients with peripheral arterial occlusive disease (PAOD).~      We describe the protocol of a single-center randomized double-blind clinical trial aimed at~     assessing the efficacy of oral magnesium supplementation in controlling severe pain in~     patients with advanced PAOD.~   "
84903|NCT02455713|"~     This study will examine the cardiopulmonary interactions that occur with increasing~     ventilator settings (PEEP and PIP) in neonates after stage I palliation for hypoplastic left~     heart syndrome before and after sternal closure. Outcome measures include oxygen delivery and~     cardiac output.~   "
84904|NCT02455700|"~     Prospective randomised crossover trial to assess if there is a difference in the level of~     pain experienced by orthodontic patients undergoing interpromixal enamel reduction at the~     lower incisor region using either a motor driven reduction device or a hand held device~   "
84905|NCT02455687|"~     Many studies have worked on the efficacy and safety of Intravenous magnesium sulfate and~     inhaled steroids beside the standard treatment for patients with severe asthma attacks.~      Investigators hypothesize that, two doses if intravenous magnesium sulfate with or without~     inhaled budesonide, would make the stay at the Pediatric emergency center (PEC) lesser,and~     decrease the need of being admitted to Pediatric Intensive Care Unit (PICU) for children with~     severe asthma attacks,compared to single dose of magnesium sulfate with or without inhaled~     budesonide.~   "
84906|NCT02455674|"~     Weight calculation based on age could be performed according to APLS (Advanced Pediatric Life~     Support) guideline recommendations in children requiring emergency treatment and intervention~     in the field or during resuscitation with no active weight and height measurements. The aim~     of the study is to investigate the suitability of weight calculation using mean ages on~     clothing size labels (ACL) to the actual weight in real emergencies with no known actual age~     of the patient (AA).~   "
84908|NCT02455648|"~     Healing of mucosal defects after endoscopic mucosal resection in the oesophagus is prone to~     result in varying degrees of stenosis, especially if the resected area is large and/or~     circumferential. A new technique was described where autologous cells from the patients own~     oral mucosa are harvested and cultures on proprietary membranes (coated, temperature~     sensitive). These membranes, coined cell sheets, are used to cover the mucosal defects.~   "
84909|NCT02455635|"~     Office hysteroscopy through vaginoscopic approach was done in gynecology out-patient clinic~     with saline distension medium. The presence or absence of lower abdominal pain and the side~     of pain were recorded. Then, transvaginal sonography within 20 minutes was done to detect the~     presence of free fluid in the pouch of Douglas. Then, laparoscopy with tubal~     chromopertubation was done.~   "
84910|NCT02455622|"~     This long-term study will provide Elaprase treatment to children enrolled in this study and~     will utilize data from both enrolled patients and Hunter Outcome Survey (HOS) patient~     registry data to conduct the primary growth analysis to assess changes in height and weight~     in patients with Mucopolysaccharidosis II (Hunter syndrome) MPS II.~   "
84911|NCT02455609|"~     Currently, opioids are widely used for pain relief, but they often provide sub-optimal~     analgesia with occasional serious side effects. Preservative-free ketamine hydrochloride was~     introduced as a spinal anesthetic more than twenty years ago and found to have advantages~     over local anesthetics. Intrathecal dexmedetomidine provides an analgesic effect in~     postoperative pain without severe sedation. The objectives of this study were to compare the~     efficacy and safety of intrathecally administered dexmedetomidine, ketamine, or their~     combination when added to bupivacaine for postoperative analgesia in major abdominal cancer~     surgery.~   "
84912|NCT02455596|"~     The purpose of this study is to evaluate the efficacy and safety of recombinant anti-tumor~     and anti-virus protein for injection in treating patients with advanced neuroendocrine tumors~     who have failed standard treatment or are unable to receive standard treatment.~   "
84913|NCT02455583|"~     The purpose of this study is to examine the effectiveness of an HIV prevention intervention~     called Project AIM (Adult Identity Mentoring) to delay onset of sexual activity and reduce~     sexual risk behaviors among students (approximate ages 12- 17 years) in junior secondary~     schools (Form 1 - 3) in Eastern Botswana.~   "
84914|NCT02455570|"~     Endoscopic ultrasound (EUS) is a mini-invasive diagnostic procedure in the work-up of various~     suspicious malignancies. The learning curve of EUS is regarded long but so far the literature~     of this topic is minimal. Few studies have been published and there are no standardized or~     validated methods to perform a systematic assessment of endosonographists in training. This~     study is an observational study dealing with the matter of assessing endosonographists in~     training.~   "
84915|NCT02455557|"~     This phase II trial studies the side effects and how well vaccine therapy works when given~     together with temozolomide in treating patients with newly diagnosed glioblastoma. Vaccines~     made from the survivin peptide or antigen may help the body build an effective immune~     response to kill tumor cells that express survivin. Drugs used in chemotherapy, such as~     temozolomide, work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. It is not yet~     known whether temozolomide is more effective with or without vaccine therapy in treating~     glioblastoma.~   "
84916|NCT02455544|"~     The aim of the study is to validate in a prospective fashion the value of the Congo-Red Dot~     (CRD) test for diagnosis of preeclampsia. The working hypothesis is that in pregnancies~     complicated by preeclampsia, will display urine congophilia and have a positive CRD test.~   "
84917|NCT02455531|"~     The purpose of this study is to compare direct and indirect measures of right ventricular~     (RV) systolic and diastolic function between 11 year old subjects who had been randomly~     assigned to receive a right ventricle to pulmonary artery shunt (RVPAS) vs. a modified~     Blalock-Taussig shunt (MBTS) at the time of the Norwood operation.~   "
84918|NCT02455518|"~     The purpose of this study is to perform a randomized, double blind 4-arm clinical trial of~     the comparative efficacy of 4 oral analgesics in the initial management of acute~     musculoskeletal extremity pain presenting to the ED.~   "
84919|NCT02455505|"~     The purpose of this study is to develop a screening tool to help identify family members who~     may need professional emotional support. The investigators are interested in enrolling family~     members of patients with advanced cancer care as well as family members who have lost a loved~     one to cancer. Some screening tools to identify family members who might need support do~     exist, but the investigators are hoping to develop one that is brief and easier for~     healthcare providers to use. The information learned in this study will help us refine the~     screening tool. The investigators are interviewing family members to identify which questions~     or items work well, which seem unclear, and to understand how a family member might approach~     completing the screening tool. Family member input will be essential in the development of~     this screening tool.~   "
84920|NCT02455492|"~     This epidemiological study investigates the association of recent stroke, acute coronary~     syndrome or pneumonia and adverse perioperative outcomes following elective non-cardiac and~     cardiac surgery using routinely collected UK primary and secondary care patient data.~   "
84921|NCT02455479|"~     The purpose of this study is to assess the safety and preliminary efficacy of an anti-cocaine~     vaccine called dAd5GNE in cocaine-dependent individuals. It uses the concept of a vaccine to~     treat the neurological effects of cocaine by evoking immunity to prevent the effects of~     cocaine on the brain.~   "
84922|NCT02455466|"~     The purpose of this study is to investigate if clinically non explainable high or low~     Prostate-specific antigen (PSA) levels are associated with heterophilic antibodies in the~     serum of participants. The investigators will examine if heterophilic antibodies are the~     reasons of altered PSA levels.~   "
84932|NCT02455323|"~     The present study aims to assess the quality of life of patients suffering from tension-type~     headache (TTH) treated for 4 weeks with different manual therapy-based techniques. The study~     design involved a factorial, randomized, double-blind, controlled study~   "
84933|NCT02455310|"~     This study will perform a retrospective analysis to evaluate the effectiveness of a~     multicomponent educational intervention to improve medication use and management of~     behavioral and psychological symptoms of dementia, relative to a statewide intervention that~     has been ongoing. Medication use and symptom severity outcomes will be compared among~     intervention counties and demographically similar non-intervention counties.~   "
84934|NCT02455297|"~     The primary objective of this study is to assess objective response rate (ORR) in patients~     with relapsed or refractory MCL who failed ibrutinib treatment or were unable to tolerate~     ibrutinib.~   "
84923|NCT02455453|"~     The purpose of this study is to evaluate the uptake of a radioactive tracer~     21-18F-fluoro-16α,17α-[(R)-(1'-α-furylmethylidene)dioxy]-19-norpregn-4-ene-3,20-dione (FFNP)~     uptake, which binds to breast cancer progesterone receptors (PgRs) on a PET/CT scan before~     and after administration of estradiol for one day (estrogen challenge) to determine if the~     change in uptake is a predictor of response to endocrine therapy (ET) in patients with~     hormone-sensitive estrogen receptor positive (ER+), human epidermal growth factor receptor~     2-negative (HER2-) breast cancer. Estradiol is the most potent of the naturally occurring~     estrogens, and can be administered to treat menopausal symptoms and also sometimes to treat~     metastatic breast cancer. The investigators propose to study patients with biopsy-proven~     newly diagnosed, locally advanced, metastatic, or recurrent breast cancer who are going to be~     treated with endocrine therapy (ET) (tamoxifen,aromatase inhibitors or fulvestrant as~     standard of care therapy.~      Subjects will undergo a total of two FFNP-PET/CT scans; one before and a second one~     immediately following the one day estradiol challenge before the start of standard of care~     ET. The estradiol challenge will consist of administering a total of 6 mg of estradiol orally~     (three doses of 2 mg each) given at approximately 8 hour intervals and over a 24 hour period.~   "
84924|NCT02455440|"~     Anesthesia techniques that minimize anesthetic requirements and their effects may be~     beneficial. Esmolol, a short acting hyperselective β-adrenergic blocker is effective in~     blunting adrenergic response to several perioperative stimuli and so it might interfere in~     the effect of the anesthetic drugs on the brain. This study was designed to investigate the~     effect of esmolol on the consumption of propofol and sevoflurane in patients undergoing~     craniotomy.~   "
84925|NCT02455427|"~     Stroke is the second cause of death worldwide and represented the first cause of death in~     Brazil between 2006 and 2010. Most patients survive, and there is a need to develop~     cost-effective rehabilitation strategies to decrease the burden of disability from stroke.~      This study addresses this important issue, by evaluating, in the early phase post-stroke,~     effects of motor conventional physical therapy associated or not with transcranial direct~     current stimulation (tDCS).~   "
84926|NCT02455414|"~     The goal of this study is to determine the pattern of early neurodegenerative changes in WFS~     (Wolfram Syndrome). The investigator will perform cross-sectional and longitudinal~     assessments of youth with WFS, targeting sensitive neural systems with quantified~     neuroimaging and behavioral measures. In addition, the investigator will establish the~     utility of a WFS severity rating scale (WFS Unified Rating Scale or WURS). Preliminary data~     support the feasibility of this approach and its potential to generate important new~     information about neurodevelopmental and neurodegenerative patterns in WFS. This work is~     necessary to position the field for future clinical trials to test interventions for WFS~     neurodegeneration. Ultimately, a better understanding of the trajectory of neurodegeneration~     in WFS and the development of effective interventions may be relevant to other more common~     neurodegenerative and endocrine (Type 1 and Type 2 diabetes) diseases in which ER stress has~     been implicated.~   "
84927|NCT02455401|"~     The purpose of this study is to compare the effect of remifentanil on postoperative vomiting~     in children undergoing strabismus surgery during sevoflurane anesthesia.~   "
84928|NCT02455388|"~     Added sugars (AS) constitute a significant source (~ 16%) of the total daily calories~     consumed by youth. The role of AS in health is contentious, and the reliance on self-reported~     dietary data is an often-cited flaw in existing research. The investigators propose to~     establish the validity of the d13C biomarker for AS intake from fingerstick blood samples in~     children; our findings could significantly advance research addressing the health impacts of~     AS intake in children and adolescents.~   "
84929|NCT02455375|"~     Routine Puumala virus (PUUV) infection diagnosis is performed using serological commercial~     kits of which performances have not been established in real life, which use recombinant~     protein from strains from Central or North Europe. Molecular diagnostic of these infection is~     not the rule. Consequently the objectives of the project are to evaluate the performances of~     the serological commercial assays in real life in France and to assess the use of urine~     versus plasma for the molecular diagnostic of this infection.~   "
84930|NCT02455362|"~     Breathlessness, the sensation of breathing discomfort, is a major problem in people with~     chronic obstructive pulmonary disease (COPD). Breathlessness that persists despite optimal~     management of the underlying disease(s) is said to be refractory.~      Preliminary evidence suggests that a small, regular dose of morphine helps to reduce safely~     the sensation of breathlessness. However, this research on morphine for breathlessness has~     not defined the best way to adjust the dose of the medication, or refined which people are~     most likely to have benefit, no response or side effects.~      This is a randomized, double-blind phase III trial in people with COPD and significant~     refractory breathlessness, which will explore several important questions:~        -  Are regular, low dose opioids (morphine) at four possible doses over 3 weeks more~          effective than placebo medication (containing no active ingredient) at improving~          breathlessness?~        -  Does the medication have any effect on daily activity, breathlessness, and quality of~          life?~        -  What are the common side effects of this intervention?~        -  Does the benefit from the drug outweigh the side effects it produces?~        -  Are there specific characteristics of people who are more likely to receive benefit from~          sustained release morphine?~      Participants will be allocated to receive three weeks of morphine sulfate (and laxative,~     docusate with senna), or placebo (and placebo laxative). The dose of morphine may be~     increased each week for weeks two and three. All medicines will appear the same (blinded) and~     neither the doctor nor the participant will know which medication the participant is~     receiving.~      Participants will have a medical interview, physical examination to collect some general~     health information, and baseline measurements including; daily activity, symptoms, and~     quality of life. A small amount of blood may be required to check eligibility. Further blood~     samples may be taken at week 1 and 3 to enable testing on how individuals respond to opioids,~     further consent will be obtained for these samples. Data on benefits, side effects, and~     medical care will be collected during comprehensive weekly visits. Participants will also~     fill out a simple diary twice daily for weeks one to three of the study, and for one day each~     week during an optional 3 month extension stage.~      The outcome of this study may enable better management of symptoms and activity in people~     COPD with medicines that are shown to be effective and safe.~   "
84931|NCT02455336|"~     Cardiovascular disease-related morbidity in persons with spinal cord injury (SCI) occurs~     earlier in life, at a greater prevalence than that of the general population, and is the~     primary cause of death after the first year of injury. During the chronic phase of SCI, a~     characteristic dyslipidemia emerges, which is characterized by low serum high density~     lipoprotein cholesterol (HDL-C) concentrations, with values often qualifying to be an~     independent risk factor for coronary artery disease, and elevations in serum triglycerides~     (TG). Serum low density lipoprotein cholesterol concentrations in those with SCI are usually~     similar to those of the general population. The current proposal in persons with SCI aims to~     determine the safety and efficacy of short-term fenofibrate treatment, an anti-lipid~     medication whose primary action lowers serum TG and raises serum HDL-C levels.~   "
84952|NCT02455050|"~     A study to evaluate the tolerability and acceptability of an investigational eye drop~     formulation in patients with Dry Eye Disease.~   "
84935|NCT02455284|"~     White matter tracts connect cortical areas to other parts of the cortex, to basal ganglia and~     to the brain stem and spinal cord. These tracts form the internal part of the brain and~     transmit the nervous impulses. Changes in brain white matter may serve as biomarkers for~     numerous neurological diseases.~      Diffusion Weighted Imaging (DWI) is a non-invasive MRI (Magnetic Resonance Imaging) technique~     providing information on white matter tracts (tractography) by studying water diffusion.~     Since it is based on complex mathematical models that only indirectly evaluates the~     underlying anatomy, tractography need to be validated before being used for research and~     clinical purposes. Several validation techniques were previously proposed, none of them being~     fully convincing in human.~   "
84936|NCT02455271|"~     To investigate the safety and efficacy of administration of eszopiclone for 6 months in~     insomnia participants.~   "
84937|NCT02455258|"~     The aim of this study is to empirically evaluate the impact of a Dance/Movement Therapy~     program adapted to older adults. Participants over 60 years old are enrolled in one of three~     groups: Dance/Movement Therapy, Aerobic Exercise or Waiting List (control group) for 12~     weeks. The training groups occur 3 times a week for 1 hour each session. Physical condition,~     cognitive function, general health and lifestyle, and stress hormones are assessed at~     baseline, after 12 weeks and after 28 weeks.~   "
84938|NCT02455245|"~     This study is trying to learn and understand if the chemotherapy drug called carboplatin~     works as well as the standard therapy. The standard therapy for Low Grade Glioma (LGG) in~     children and young adults is using a combination of carboplatin and vincristine. Studies in~     children have shown that the use of carboplatin alone has promise of being just as effective~     for treating LGG as standard therapy. Additionally, this study will try to understand if~     treatment with carboplatin alone is associated with an improved quality of life for LGG~     patients and their families.~   "
84939|NCT02455232|"~     The aim of this study is to determinate what are the main muscles regularly involved in the~     spastic pattern in flexion of the elbow using the selective motor nerve blocks of the elbow~     flexors. Three selective motor block nerves will be carry out in order to assess the gain of~     the range of motion (passive and active) of the elbow after each Motor Block Nerve.~   "
84940|NCT02455219|"~     A collimator is an accessory to a SPECT/CT scanner. It can be compared to a camera lens or~     filter that enhances or improves photos. The prototype collimators are able to magnify target~     organs about four times compared to the current collimators. In this study we are validating~     a new collimator design, which will allow for quantitative measurement of dopamine receptors~     within the brain, not previously performed using a single photon gamma camera.~   "
84941|NCT02455206|"~     The purpose of this study is to investigate if a physical activity counseling program during~     pulmonary rehabilitation increases the physical activity level in daily life in patients with~     Chronic Obstructive Pulmonary Disease.~   "
84942|NCT02455193|"~     This study plans to learn more about how common drugs prescribed to individuals with~     schizophrenia contribute to weight gain, as well as how exercise and diet impact appetite and~     the brain's response to food. In this study, the investigators will be evaluating how~     patients' brains respond to food images as well as asking questions about their food~     preferences and intake and clinical symptoms. The investigators may also ask patients to~     complete an exercise or diet intervention to see how this changes brain responses or food~     preferences.~   "
84943|NCT02455180|"~     The purpose of this study is to determine the pharmacokinetic properties of two different~     dosage regimens of intravenous vitamin C in patients admitted to the Intensive Care Unit with~     life-threatening illness.~   "
84944|NCT02455167|"~     1. Achieve sustained virologic response (SVR) in patients infected with HCV genotype 1,~          cirrhosis, and early clinical decompensation using 12 weeks of Olysio/Sovaldi/Ribavirin~          (or known as: Simeprevir(SMV)/Sofosbuvir(SOF)/Ribavirin (RBV).~        2. Hepatic improvement during and after Simeprevir(SMV)/Sofosbuvir(SOF)/Ribavirin(RBV)~          treatment using a new test of liver function, HepQuant-SHUNT.~   "
84945|NCT02455154|"~     To test the efficacy of two Traditional Chinese Medicine in preventing osteoporosis in~     patients receiving adjuvant endocrine therapy.~   "
84946|NCT02455141|"~     To compare disease-free survival (DFS) rate of adjuvant chemotherapy~     epirubicin-cyclophosphamide followed by weekly paclitaxel or docetaxel (EC-T), or weekly~     paclitaxel or docetaxel-carboplatin (EC-TCb) in triple-negative breast cancer.~   "
84947|NCT02455128|"~     This is a randomized clinical trial that aims to investigate the effect of therapeutic~     listening anxiety and preoperative fear of patients hospitalized for surgical treatment of~     colorectal cancer. Physiological variables will be evaluated (heart rate, blood pressure and~     respiratory rate), cortisol and salivary amylase and anxiety scores by State-Trait Anxiety~     Inventory and fear for Surgery Fear Questionnaire. The data of the variables will be compared~     at two different times (before and after the intervention).~   "
84948|NCT02455115|"~     Comparing the effects of MAP 60, 75 and 90 mmHg, respectively, on renal blood flow,~     glomerular filtration rate and renal oxygen demand in patients with terminal liver failure~     directly after liver transplantation.~   "
84949|NCT02455102|"~     The aim of this randomized controlled study is to evaluate whether a newly designed~     electronic warning system will increase the initiation rate of adequate stroke preventive~     measures in patients with atrial fibrillation.~   "
84950|NCT02455089|"~     Given that GADD34 has been described as a potential key regulator of pro-inflammatory~     cytokine production in human and elevated blood marker in SLE patients, this study aim to~     prove that the GADD34 RNA level in mononuclear blood cells can be used as a prognostic marker~     to assess the risk of SLE flare.~   "
84951|NCT02455076|"~     The purpose of this study is to try and achieve similar glycemic control in general~     non-Intensive Care Unit (non-ICU) patients with Type 2 Diabetes with exenatide alone or in~     combination with basal insulin as compared to treatment with basal bolus insulin alone. The~     association between hyperglycemia and poor clinical outcomes in patients with diabetes is~     well established. Previous studies have shown that basal bolus insulin regimens improve~     glycemic control and reduce the rate of hospital complications compared to sliding scale~     regular insulin (SSRI) therapy, but has a significant risk of hypoglycemia. The investigators~     will compare the efficacy and safety of exenatide alone or in combination with basal insulin~     to control high blood glucose levels resulting in a lower risk of hypoglycemia.~   "
84954|NCT02455024|"~     This is an observational registry to further characterize the safety profile of patients with~     chronic myeloid leukemia in the chronic phase (CP-CML), accelerated phase (AP-CML), blast~     phase (BP-CML), or Ph+ALL treated with Iclusig (ponatinib) in routine clinical practice in~     the US. The registry is focused on analysis of vascular occlusive events.~   "
84955|NCT02455011|"~     This is a randomized, placebo-controlled, double-blind, dose escalation study to evaluate~     safety, tolerability, PK and PD of single and repeated SC doses of REMD-477 in Type 2~     diabetic subjects. The study will be conducted at multiple sites in the United States and~     will enroll approximately 102 subjects with Type 2 diabetes who are either treatment-naïve,~     controlled with diet and exercise or treated with oral antidiabetic medications.~   "
84956|NCT02454998|"~     Alveolar bone grafting (ABG) is an essential part of the surgical management of cleft lip and~     palate patients. This procedure could obliterate oronasal fistula, stabilize dental arch,~     offer bone matrix for adjacent teeth eruption. Moreover, by obliterating oronasal fistula, we~     stop the chronic irritation of nasal mucosa by oral content. Hence, the symptoms of~     rhinorrhea or nasal obstruction could be improved. This dental arch defect could predispose~     further dental arch medial collapse. Without alveolar bone grafting the dental arch is not~     stable, dental movement during orthodontic treatment is limited and dental arch expansion is~     not possible.~      Previous to operation, the patient suffered from dental crowding and dental inclination~     toward to the cleft. This produces a difficult dental hygiene and predispose to dental caries~     and gingivitis. Pre-operative orthodontics treatment is advised in many centers. By aligned~     the teeth previous to surgery, with a better dental hygiene, we purpose that the infection~     rate will be reduced and success rate will be better.~      The Purpose of this study is to determine whether pre-operative orthopedic treatment will~     affect secondary alveolar bone grafting outcome and to assess the nasal change after alveolar~     bone graft.~   "
84957|NCT02454972|"~     A Multicenter Phase II Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid~     Tumors to assess the antitumor activity of lurbinectedin (PM01183) in terms of overall~     response rate (ORR), in the following advanced solid tumors: small cell lung cancer (SCLC),~     head and neck carcinoma (H&N), neuroendocrine tumors (NETs), biliary tract carcinoma,~     endometrial carcinoma, BRCA 1/2-associated metastatic breast carcinoma, carcinoma of unknown~     primary site, germ cell tumors (GCTs), and Ewing's family of tumors (EFTs)~   "
84958|NCT02454959|"~     This is a Randomized, Phase III, Two-period, Open-label, Chronic-dosing (7 Days),~     Multi-center, Crossover Study to Assess the Efficacy of PT003 in Subjects with Moderate to~     Severe COPD with and without a Valved Holding Chamber.~   "
84959|NCT02454946|"~     The researchers aimed to investigate the relationship between ABO blood types and erectile~     dysfunction.~   "
84960|NCT02454933|"~     A Phase III, Multi-Centre, Open Label, Randomized Study to Assess the Efficacy and Safety of~     AZD9291 in Combination with MEDI4736 versus AZD9291 Monotherapy in patients with Locally~     Advanced or Metastatic Epidermal Growth Factor Receptor T790M mutation-positive Non-Small~     Cell Lung Cancer who have received Prior Epidermal Growth Factor Receptor Tyrosine Kinase~     Inhibitor Therapy~   "
84961|NCT02454920|"~     Study designed to determine the ability and accuracy of anterior segment optical coherence~     tomography (AS-OCT) to measure the distance between the corneoscleral limbus and the~     insertion site of the extraocular muscles (EOM) in adults with and without previous~     strabismus surgery. And to compare in surgical patients the pre-operative AS-OCT~     limbal-muscle insertion distance measurement to the intraoperative limbal-muscle insertion~     measurement using calipers (gold standard).~   "
84962|NCT02454907|"~     Many patients with multiple sclerosis (MS) experience relapses of disease activity during~     which they have increased numbness, weakness, visual problems, or other symptoms. If a person~     with MS has new symptoms that are concerning to them, their doctor may want to see them in~     the office in order to confirm that these symptoms are due to a true relapse of activity~     before starting relapse treatment. This requirement can be frustrating for patients, who may~     have to take time off from work or travel long distances for such unexpected doctors' visits.~     In this study, the investigators will use input from patients with MS and MS physicians to~     create a relapse questionnaire that can be used to confirm a relapse has occurred. The~     investigators will also evaluate if having a more direct line of communication with the~     provider's office improves overall patient care and satisfaction.~   "
84963|NCT02454894|"~     The study is carried out in a prospective randomized controlled way. In the context of~     informed understanding from parents, compared with traditional process(no anesthesia; lying~     without the pillow and fasting water and food for four hours after lumbar puncture), randomly~     select lidocaine surface anesthesia and postoperative management (lying without the pillow~     for half an hour after lumbar puncture) . All children will be evaluated by the FLACC(The~     face,legs,activity,cry,consolability behavioral tool) scale to assess the degree of pain~     during and after lumbar puncture. Lumber puncture time, success rate and any postoperative~     condition will be recorded and analyzed.A questionaire about the operation for all parents~     and children will be investigated in order to establish an optimized lumbar puncture~     management process.~   "
84964|NCT02454881|"~     To study the multimodal protocol combining adjunct dexmedetomidine with oxycodone in~     intravenous patient-controlled analgesia bolus dosing and effects in patients scheduled for~     posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation.~   "
84965|NCT02454868|"~     Introduction: remifentanil's optimal dose for children intubation without neuromuscular~     blockade is unknown. Method: phase IV adaptative trial using Dixon's up-and-down method for~     modeling remifentanil's dose-response curve for adequate intubation conditions as defined by~     previous studies.~   "
84966|NCT02454855|"~     Melatonin may represent an effective complementary treatment to standard chemotherapy in~     order to reduce asthenia, depression, sleep disturbances, cognitive impairment and~     performance status as part of quality of life. Moreover, melatonin has been evaluated in~     several clinical trials in cancer patients with no side effects . It could be particularly of~     interest in elderly cancer patients as they exhibit a significant deficiency of melatonin~     production .~      The investigators propose to perform a prospective and randomized study to study the effect~     of a melatonin supplementation on the quality of life of elderly advanced/metastatic cancer~     patients (age ≥ 70) treated by chemotherapy.~   "
84968|NCT02454829|"~     Evaluation of ovarian function by a questionnaire and by medical file analysis of women and~     girls who underwent ovarian cortex cryopreservation for fertility preservation between 1997~     an 2013 in the investigators' institution in order to evaluate their residual ovarian~     function. A second part of the questionnaire concerns these women's satisfaction regarding~     the procedure.~   "
84969|NCT02454816|"~     Global and regional initiatives have been launched for the dual elimination of~     mother-to-child transmission (MTCT) of HIV and syphilis. As one of the important components~     in the initiatives, early detection and timely intervention of pregnant women infected with~     HIV and/or syphilis is critical. In order to improve the number of women tested and treated,~     innovative strategies are needed.~      Serologic tests are the diagnostic tests of choice for HIV and syphilis. There are two types~     of serological tests (treponemal and non-treponemal tests) for diagnosis of syphilis. These~     generally require venous blood for screening of symptomatic and asymptomatic patients. In~     addition, these tests are technically demanding, and require laboratory equipment which is~     not widely available in most resource-limited settings.~      Recently, Rapid diagnostic tests (RDTs) that can be used at point-of-care for simultaneously~     detecting antibodies to HIV and syphilis (dual HIV & syphilis treponemalRDTs) using~     serum/plasma, venous whole blood, or finger-stick whole blood have been developed and are now~     commercially available.~      In low-resource settings, a combination of two or three rapid diagnostic tests (RDTs), in~     which one screening test with a second test to confirm initial positive results or two RDTs~     in parallel with a third test as a tiebreaker for discordant samples, can be used to diagnose~     HIV on finger-stick blood. To date, there are few data on the implications of using these~     RDTs in the antenatal clinic settings, although they have been evaluated in laboratory-based~     studies and shown encouraging sensitivities and specificities as compared with reference~     laboratory tests.~      The objective of this research is to assess the uptake of syphilis testing after the~     introduction of dual HIV/syphilis rapid testing as compared to single rapid syphilis testing~     in antenatal clinics in Colombia.~      The secondary objectives of the study are: To determine the uptake of treatment of syphilis~     after the intervention, To determine the uptake of HIV testing in ANC attendees after the~     intervention, To explore the acceptability of dual HIV/syphilis RDTs by ANC attendees and~     health workers, To assess the organizational and socio-cultural advantages and barriers to~     introduction with a aim of sustainable adoption of dual HIV/syphilis RDTs in antenatal~     services, To determine the workload and cost implications of introduction of dual~     HIV/syphilis RDTs in antenatal services~   "
84970|NCT02454803|"~     The primary purpose for this study is to understand the effect of botulinum toxin as a~     treatment integrated in the management of spasticity (stiffness) in the arm and/or hand,~     arising from any neurological condition. The study will look at the types of goals that~     people choose for treatment, and the extent to which these are achieved in different~     individuals.~   "
84971|NCT02454790|"~     Motive:~      In order to improve the treatment technique, a comprehensive follow-up program is needed to~     obtain all relevant patient, treatment and toxicity data from esophageal cancer patients.~      Goal:~      To set-up and maintain a database containing treatment results in terms of tumor control,~     side effects, complications and patient-reported quality of life.~      A standard database of patients receiving photon treatment will be created. These data are~     then linked to dose-volume data of radiotherapy, with the aim to build prediction models for~     both tumor control and toxicity after radio (chemo) therapy that can later be used for~     selecting patients for proton treatment.~   "
84972|NCT02454777|"~     This randomized pilot clinical trial studies the feasibility of high-intensity interval~     training in improving cardiovascular fitness in patients with stage I-III breast cancer~     undergoing chemotherapy with trastuzumab. Trastuzumab helps patients live longer, but may~     cause side effects to the heart. Aerobic exercise may help the heart function better, which~     may help protect it against side effects from trastuzumab. Exercise may also help reduce~     fatigue and prevent cancer from coming back. High-intensity interval training involves short~     bursts of higher intensity efforts with longer periods of recovery. This may also allow~     patients who cannot exercise for a long period of time to still be physically active. This~     trial studies whether patients can tolerate high-intensity interval training, and how well it~     works in improving fitness in patients with breast cancer receiving trastuzumab.~   "
84973|NCT02454764|"~     After fulfillment of the selection criteria, all the patients included in the trial will be~     administered Tenofovir that will be continued for 3 months and then stopped for 1 month,~     LFT's, HBV DNA, HBsAg, will be checked weekly during the time period of stopping Tenofovir~     and thereafter at 4 months patients with ALT >/= 1.5 times ULN will be randomised in 2 groups~     to administer either Peg INF alpha 2b + Tenofovir (in same dose as before) or Tenofovir alone~     which will be continued for 48 weeks and the patients with no rise in ALT will be excluded.~     Patients will be closely monitored during the period of stopping tenofovir post pulse therapy~     and liver function tests will be performed weekly. Patients will be closely observed for the~     development of acute hepatitis or decompensation during the 4 - week period of drug~     withdrawal. Thereafter, CBC, KFT, LFT's, PT-INR, HBsAg (Q), HBeAg and HBV DNA levels will be~     tested every 3 months. After stopping treatment followup will be done at 24 weeks post~     stoppage of treatment to look for sustained seroconversion and virological/biochemical~     response~   "
84974|NCT02454751|"~     Study Objective The primary object of this study is to investigate the safety and~     effectiveness of fentanyl on the management of incident dyspnea.~      Study Design The study design will be a cross over study with a minimum of a one hour wash~     out period.~   "
84975|NCT02454738|"~     To evaluate CT abnormalities in the lung parenchyma in close contacts at high risk for~     developing multidrug- or extensively drug-resistant Tb by using a follow-up ultralow dose CT~     scan.~   "
84976|NCT02454725|"~     Early HIV diagnosis followed by linkage to treatment soon after HIV infection can reduce~     mortality and prevent new HIV infections. To obtain the full benefit of early HIV diagnosis,~     the US Centers for Disease Control and Prevention suggest that high risk groups get tested~     for HIV regularly, every three to six months. This study will examine the feasibility of a~     strategy to promote regular HIV testing and HIV risk reduction among Latino men at risk for~     HIV which, if successful, will help to identify Latino men unaware of their HIV status,~     benefitting them and the society.~   "
84977|NCT02454712|"~     PF614 is an oxycodone prodrug that is designed for extended-release of oxycodone comparable~     to OxyContin. This Single Ascending Dose (SAD) study is designed to assess the safety and~     pharmacokinetics (PK) of PF614 in comparison to standard doses of OxyContin.~   "
84978|NCT02454699|"~     This is a phase I safety, PK and food effect study of the CMV drug. In part 1 of the study,~     subjects will receive one of four dosage strengths of MBX-400 (100 mg once daily, 350 mg once~     daily; 750 mg once daily; and 1000 once daily) for 7 days and safety and PK will be assessed.~     Subjects must be 18 to 65 years of age, male or female; if female, be surgically-sterilized~     or post-menopausal; if male, have undergone vasectomy; have a body mass index (BMI) of 18 to~     32 kg/m^2; not be a user of nicotine-containing products; be willing to abstain from~     nicotine-containing products, alcohol and illicit drugs during the study. Subjects will be~     followed for 28 days post dosing.~   "
84979|NCT02454686|"~     Most of the postoperative complications that may occur after hepatectomy are related to the~     underlying liver background, and the common preoperative tests do not completely predict such~     complications. Transient elastography by Fibroscan is used to calculate the stiffness and the~     steatosis of the liver, and it may be also used to predict postoperative complications after~     hepatectomy~   "
84980|NCT02454673|"~     The purpose of this study is to evaluate whether the R0 rate, pathological response degree,~     patterns of recurrence and long-term outcomes may be initially predicted in patients with~     locally advanced gastroesophageal junction and gastric cancer treated with a neoadjuvant~     approach and salvage surgery.~   "
84981|NCT02454660|"~     Uncontrolled hypertension is a major cause of morbidity and mortality and many patients fail~     to take their antihypertensive medication as prescribed. The investigators propose to use~     artificial intelligence (AI) to allow short message service (SMS or text messages)~     interventions to adapt to patients' adherence needs and substantially improve medication~     taking. The aims of the study are to: (1) develop AI methods for adaptive decision-making in~     human-centered environments and demonstrate the feasibility of the resulting AI-enhanced SMS~     medication adherence intervention, (2) demonstrate that the intervention can learn by~     adapting the SMS message stream according to patients' medication taking over time, and (3)~     examine potential intervention impact as measured by improvements in medication adherence and~     systolic blood pressures. The investigators will recruit 100 patients with uncontrolled~     hypertension and antihypertensive medication non-adherence. Adherence and other covariates~     will be measured via surveys at baseline, 3- and 6 months; blood pressures will be measured~     at baseline and 6 months. Participants will be given an electronic pill-bottle adherence~     monitor. Participants will receive SMS messages designed to motivate antihypertensive~     medication adherence. Message content and frequency will adapt automatically using AI~     algorithms designed to automatically optimize expected pill bottle opening. For Aim 1, the~     first 25 patients will be enrolled to develop and test alternative RL algorithms and~     fine-tune the system parameters. For Aim 2, the investigators will examine changes in the~     probability distribution over message-types and compare that distribution with patients'~     reasons for non-adherence reported at baseline. For Aim 3, the investigators will examine~     changes in self-reported medication non-adherence and blood pressure and~     automatically-reported pill bottle openings. This pilot study will establish the feasibility~     and potential impact of this novel approach to mobile health messaging for self-management~     support. The results will be used to support an R01 application for a larger and more~     definitive trial of intervention impacts.~   "
84982|NCT02454647|"~     The aim of this study is to evaluate the efficacy of a neoadjuvant approach in patients with~     locally advanced gastric cancer and the identification of prognostic factors.~   "
84983|NCT02454634|"~     The NOA-16 trial is the first-in-man trial of the IDH1 (isocitrate dehydrogenase type 1)~     peptide vaccine targeting the IDH1R132H mutation (amino acid exchange from arginine to~     glutamine at position 132 of IDH1). The aim of this trial is to evaluate the safety and~     tolerability of and immune response to the IDH1 peptide vaccine in patients with~     IDH1R132H-mutated, WHO grade III-IV gliomas.~   "
84984|NCT02454621|"~     The study will recruit patients who smoke from a general practice clinic and randomize them~     either to: (1) form implementation intentions by linking in memory situations in which they~     are tempted to smoke with strategies to avoid smoking in those situations using a volitional~     help sheet, or (2) to consider the situations in which they are tempted to smoke alongside~     possible strategies to avoid smoking as presented in the volitional help sheet but not to~     form implementation intentions. The effects on self-reported smoking will be assessed 1 month~     post-intervention.~   "
84985|NCT02454608|"~     Verapamil is an L-type calcium channel blocker(CCB) which has been shown to reduce~     inflammation in a variety of tissues. Verapamil has also been shown to improve eosinophilic~     inflammation in an animal model of asthma and also functions as a P-glycoprotein(P-gp)~     inhibitor. A major subtype of chronic rhinosinusitis(CRS) is characterized by eosinophilic~     inflammation as well as P-gp overexpression. The goal of this study is to therefore see~     whether Verapamil may be used to treat CRS.~   "
84986|NCT02454595|"~     This is a prospective open registry to measure the impact on first-line therapy of genomic~     testing of biopsy tissue from recently diagnosed treatment-naïve patients with early stage~     localized prostate cancer. Physicians will complete a series of questionnaires. Biopsy tissue~     will be tested using the Prolaris® genomic test and a relative cancer aggressiveness score~     will be shared with the physician and the patient.~   "
84987|NCT02454582|"~     SUMMARY AND AIM~      Background:~      The proper management of brain oxygenation is an essential component of all anaesthesiologic~     procedures. Nevertheless, the brain remains one of the least monitored organs in the~     perioperative phase and intensive care therapy.~      The INVOS Brain Oxymeter (IBO) is a reliable trend monitor for changes in regional cerebral~     oxygenation (rSO2).~      It is a current assumption that rSO2 directly correlates with Sa02, which can be influenced~     by different ventilation assistance systems, e.g. CPAP therapy.~      Objectives:~      The project aims at investigating changes of rSO2 in patients undergoing CPAP therapy for~     max. 15 minutes, in order to evaluate the effect of CPAP on cerebral oxygenation.~      Methods:~      NIRS measurement (with IBO) will be performed on the temporoparietal cortex on both sides of~     the head. The trial will consist of two parts i.e. with or without ventilatory assistance.~     The order of starting the study with or without CPAP therapy will be randomized. During each~     part the measurements will be performed until reaching a steady state (no change in rSO2 ± 2%~     for 3 min) but with a maximum duration of 15min. After each interval a BGA (blood gas~     analysis) will be performed.~   "
84988|NCT02454569|"~     The VFHCS is a long-term prospective cohort study of HIV infected patients from a~     resource-poor rural setting in India. The aim of the study is to use data collected from~     routine clinical care in order to describe the epidemiology of HIV and its related conditions~     in the investigators area, and to study the effectiveness of health interventions in a~     real-world setting (implementation and operational research).~   "
84989|NCT02454556|"~     This is an open-label, Phase 3, randomized, two arms, multicenter, prospective, experimental~     study of Folitime® (a new biosimilar formulation of r-hFSH, follitropin alfa) versus the~     original one (Gonal-f ®).~   "
84990|NCT02454543|"~     The aim of the study is to investigate, the effect of radical prostatectomy with extended~     lymphadenectomy on cancer-specific survival, time to castration-resistance, time to~     progression and quality of life in patients with a limited bone metastatic prostate cancer.~     In addition the influence of patient- and disease-related factors on clinical outcome~     (prognostic effect) and on the comparison therapy (predictive effect) will be examined.~   "
84991|NCT02454530|"~     The aim of this study is to describe in real-life conditions the determinants of use of GCSF~     (Granulocyte Colony-Stimulating Factor) Nivestim® in primary or secondary prophylaxis and in~     patients receiving chemotherapy for solid tumour according to the chemotherapy context:~     adjuvant or metastatic setting.~   "
85071|NCT02453477|"~     This is a phase I/II study evaluating safety and efficacy of autologous hematopoietic stem~     cells genetically modified with GLOBE lentiviral vector encoding for the human beta-globin~     gene for the treatment of patients affected by transfusion dependent beta-thalassemia~   "
84992|NCT02454517|"~     This randomized phase III trial studies a diet and exercise program based on the Diabetes~     Prevention Program to promote weight loss and improve health in men with low-risk or~     low-intermediate-risk prostate cancer on active surveillance. A lifestyle intervention that~     promotes weight loss may influence prostate health. A combined diet and exercise program that~     is based on the Diabetes Prevention Program may affect markers (or biomarkers) of prostate~     cancer progression. Gathering this information may help doctors understand how obesity~     affects prostate cancer progression and may help lead to a program that can reduce the risk~     of prostate cancer progression.~   "
84993|NCT02454504|"~     With the aim of enhancing the quality of surgery, the robotic cystectomy is often conducted~     using continuous intravenous infusion of curare, which ensures maximum neuromuscular~     relaxation until the end of the intervention. Sugammadex, administered for the reversal of~     deep neuromuscular blocked, enable rapid awakening. Moreover, Sugammadex seems to have a~     positive effect also on the recovery of cognitive function, psychomotor coordination and~     mental ability, effects undocumented in Literature.~      The aim of the investigators study was to assess whether the reversal with sugammadex after~     intraoperative continuous infusion of rocuronium, can improve the quality of awakening.~   "
84994|NCT02454491|"~     Transradial approach (TRA) for cardiac catheterization and percutaneous coronary~     interventions (PCI) is increasingly being used worldwide. At the present is unknown the~     cocktail of agents necessary to minimize local access site complications. The investigators~     planned a prospective randomized clinical trial to test the superiority of verapamil vs.~     heparin in the reduction of access site related complications.~   "
84995|NCT02454478|"~     Phase 1 study to investigate the tolerability and safety of lenvatinib in combination with~     Everolimus in participants with unresectable advanced or metastatic RCC.~   "
84996|NCT02454465|"~     With an increase of over 38% in neurological related hospital admissions between 2008-13,~     there are now over 12.5 million cases of individuals with neurological conditions in the UK.~     Following diagnosis of a neurological condition, there is often a period of adjustment to new~     life circumstances, with changes to relationships, ability to work and leisure activities.~     With a future often fraught with uncertainty, psychological difficulties such as Anxiety and~     Depression are common. It is estimated that following diagnosis of a neurological condition,~     up to 60% of individual's will experience mental health difficulties.~      Acceptance and Commitment Therapy (ACT) has been gaining popularity in supporting those with~     neurological conditions. ACT is based on emotional acceptance and supporting individuals to~     live a valued life, despite ongoing symptoms. Research into the use of ACT with this~     population has found it to be effective in reducing levels of psychological distress and~     increasing psychological flexibility.~      With limited resources and an ever increasing desire to improve interventions offered to~     patients, services are now looking at new and innovative ways of offering increasingly~     effective and satisfactory treatments. Therefore, in early 2014, the author devised a six~     week ACT group intervention for adjustment following diagnosis of a neurological condition.~     The intervention provides a combination of ACT techniques, in addition to a space for group~     members to build relationships and share their difficulties, to help individuals increase~     acceptance of their difficulties and reduce psychological distress.~      Following an initial pilot, findings illustrated that participants' psychological distress~     reduced and psychological flexibility increased. Therefore, this research project aims to~     further evaluate the intervention under controlled conditions.~   "
84997|NCT02454452|"~     Randomized controlled clinical trial aimed to compare the effectiveness and safety of~     radiofrequency, saphenous vein stripping and conservative hemodynamic treatment of venous~     insufficiency (CHIVA) in the treatment of saphenous varicose veins, in terms of absence of~     saphenous vein reflux, patient quality of life and post-surgical complications.~   "
84998|NCT02454439|"~     The aim of the NICD-CRT study is to assess whether CRT may be clinically beneficial in HF~     patients with NICD and reduced ejection fraction on 12-month HF status.~      In effect, the effectiveness of cardiac resynchronization therapy in heart failure (HF) with~     reduced ejection fraction patients with non specific intraventricular conduction delay (NICD)~     has never been confirmed even if it is recommended.~      At the moment, no dedicated study has already been performed to assess the benefit of CRT in~     patients with NICD. Results from CRT therapy are contradictory in this patient group and have~     only been obtained from subgroup analysis. Some of them don't show clinical benefit but~     others show a benefit in term of an end-diastolic and/or end-systolic left ventricular volume~     (decrease of the size and the volumes of left ventricule).~      The AHA/ACCF guidelines, published in 2005 and updated in 2009, considered only QRS duration~     (≥120 ms) for the indication of CRT implantation, without any consideration for the type of~     conduction disorder (i.e. LBBB vs. non-LBBB), current updated 2012 ACCF/AHA/HRS guidelines,~     consider QRS morphology (i.e. LBBB) as the first step for CRT candidate selection in addition~     to QRS duration (>150 ms). Indications for resynchronization have been restricted since~     indication of CRT in non-LBBB patients (e.g. NICD) is only a class IIa (>150 ms, only in NYHA~     III and ambulatory IV; level of evidence A). The same modifications have been applied between~     2011 and 2013 in the European guidelines. None is known about patients with NICD and QRS >~     130 ms.~   "
84999|NCT02454426|"~     This is a preliminary, open-label, clinical trial designed to assess the efficacy, safety,~     and tolerability of vortioxetine for the treatment of major depressive disorder in patients~     with coronary artery disease. In addition, the study will assess the effects of vortioxetine~     on heart rate variability in these patients.~   "
85000|NCT02454413|"~     Clinical guidelines for denture care are available, but evidence for optimal nocturnal~     storage is missing. The investigators (Duyck J., Vandamme K., Teughels W.) therefore~     performed a study (submitted for publication) to evaluate the effect of different overnight~     storage protocols on denture biofilm formation and maturation. The results of this study~     showed that the use of cleansing tablets (Corega Tabs Anti-bacteria®, GlaxoSmithKline~     Consumer Healthcare SA, Genval, Belgium) for acrylic removable denture overnight storage~     reduces denture biofilm mass and pathogenicity compared to dry and water preservation. As no~     mechanical denture cleaning was performed in the aforementioned study, the aim of the~     proposed study is to evaluate the combined effect of mechanical cleaning and overnight~     storage condition on the microbial composition and Candida albicans colonization of denture~     biofilm formation. This information is required to develop a clinical guideline on acrylic~     denture cleaning and overnight storage aiming to reduce the risk posed by pathogenic~     microorganisms, particularly in bedridden and immunocompromised patients.~      It is hypothetised that mechanical denture cleaning will decrease the impact of overnight~     denture storage condition on biofilm formation on acrylic removable dentures.~   "
85001|NCT02454400|"~     The aim is to study if pre-surgery physiotherapy improves function, pain and health in~     patients with specific low back pain scheduled for surgery. Patients are followed over a two~     year period. A secondary aim is to study what factors predict short and long term outcomes.~   "
85002|NCT02454387|"~     A Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacology of~     ONO-4474 in healthy volunteers.~   "
85003|NCT02454374|"~     This study is a randomised controlled clinical trial designed to evaluate the effectiveness~     of two different exercise based treatments in the management of patients with knee problems~     related to degenerative (wear and tear) changes.~      Recent evidence suggests that putting weight through a joint (joint loading) may be~     beneficial.~      The Investigators know that physiotherapy and exercise is important in treating these~     patients, but the investigators do not know which exercises work best. In this study the~     investigators will be comparing current physiotherapy care against a new programme of~     exercises that gradually increases the amount of joint loading.~      The study will recruit approximately 140 patients from the Leeds Musculoskeletal (MSK)~     service, who are over the age of 45 and have been referred for physiotherapy by their GP for~     activity related knee pain.Patients who are suitable and happy to take part will be selected~     randomly (not chosen by the patient or physiotherapist) to receive either normal~     physiotherapy treatment, or the knee loading exercises. The treatment phase will last for six~     weeks and participants will be asked to carry out their exercises twice daily during this~     time. At the end of this period, patients will be asked tocomplete questionnaires and again~     at six months so that the investigators can assess how the patients are doing.~      The main aim is to evaluate clinical effectiveness of the progressive joint loading protocol.~     However, the data collected will also be used to see if there is a way of identifying in~     advance those who might respond better to either treatment.~      The investigators will also collect some information relating to the cost effectiveness of~     delivering different treatments. The final aim of this study is to test how easy it is to~     collect more detailed data in this area if a related study were to be carried out in the~     future.~   "
85004|NCT02454361|"~     This is a randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the~     safety, tolerability and pharmacokinetics of a single dose of KBP-7072 following oral single~     ascending dose administration and with an open label food effect panel.~   "
85005|NCT02454348|"~     Sepsis, a systemic host response to the invasion of a pathogenic microorganism, may progress~     to severe sepsis, wherein the patient experiences acute dysfunction in at least one organ~     system, and further develop into septic shock if the patient cannot regain adequate systemic~     blood pressure and perfusion after adequate and appropriate fluid resuscitation. Further~     prospective study of the potential mortality benefit with combination norepinephrine and~     vasopressin in critically ill patients with septic shock needs to be performed. Our research~     will resolve this essential question and improve the scientific knowledge surrounding~     vasoactive medications in patients with septic shock.~   "
85006|NCT02454335|"~     Per-oral endoscopic myotomy (POEM) is an incisionless procedure used to treat esophageal~     achalasia, performed by GI endoscopist without cutting any surface of the human body. The~     main constituent of the procedure is the myotomy part, through which the endoscopist cuts the~     muscle fibers in the submucosa. Since this procedure is completely new to the area of~     treatment of achalasia, it is unknown whether a posterior or an anterior myotomy is better in~     relieving the symptoms. Thenceforth, this study aims at randomizing patients with achalasia~     presenting for POEM to getting either the posterior or the anterior myotomy. Patients will be~     followed up for symptoms and complications; data will be extracted and the appropriate~     analysis will be employed to determine if there is any difference of outcome between the two~     techniques of myotomy.~   "
85007|NCT02454322|"~     Magnesium is sometimes used to prevent seizures in the setting of hypertensive disorders of~     pregnancy. The primary aim of this study is to determine if women who receive magnesium are~     less likely to experience postpartum depression. Other aims include examining the~     relationship between receiving magnesium and cognitive function and birth experience.~   "
85008|NCT02454309|"~     This study aims to determine whether a cranberry concentrate reduces recurrent urinary tract~     infections (UTIs) in women. Approximately 150 adult women will be recruited to participate in~     this study. Subjects will be randomized to either the cranberry supplement or placebo~     treatment for 12 months. Subjects and investigators will be blinded to which supplement they~     are taking.~   "
85009|NCT02454296|"~     To assess if paracervical block is effective at reducing discomfort during placement of~     intracervical laminaria for pre-operative cervical preparation.~   "
85010|NCT02454283|"~     LGN-VN-003 is a prospective, multi-center, randomized, double-blind, placebo-controlled study~     to evaluate the safety and efficacy of a single oral dose of vanoxerine for the conversion of~     subjects with recent onset atrial fibrillation (AF) or atrial flutter (AFL) to normal sinus~     rhythm. Up to 625 subjects will be randomized in a 2:1 fashion so at least 400 vanoxerine and~     200 placebo subjects receive study drug.~   "
85011|NCT02454270|"~     The purpose of this study is to evaluate the safety, tolerability, dose-limiting toxicities~     (any harmful effect of a drug) (DLT), maximum tolerated dose (MTD), recommended Phase 2 dose~     (RP2D) and preliminary clinical activity of duvortuxizumab when administered intravenously to~     participants with relapsed or refractory B-cell malignancies [diffuse-large B cell lymphoma~     (DLBCL), follicular lymphoma (FL), mantle-cell lymphoma (MCL), chronic lymphocytic leukemia~     (CLL), and acute lymphoblastic leukemia (ALL)].~   "
85012|NCT02454257|"~     The aim of the proposed study is to better understand the epidemiology of, risk factors for~     and consequences of critical illness leading to improvements in the risk models used to~     underpin national clinical audits for adult general critical care, cardiothoracic critical~     care and in-hospital cardiac arrest using data linkage with other routinely collected data~     sources.~   "
85013|NCT02454244|"~     Amygdala Retraining Treatment (ART) is a new and promising therapy for patients with Chronic~     Fatigue Syndrome (CFS) and Fibromyalgia (FM), however, randomized controlled trials (RCT) are~     scarce. The investigators have added mindfulness to this therapy, based on preliminary~     reports of its efficacy on patients, obtaining Amygdala Retraining Treatment with Mindfulness~     (ART+MF).~      Other therapy that has been assessed in many psychiatric and medical disorders during the~     last years has been Compassion Therapy (CT). There are no studies on its efficacy in FM.~      Aims: The aim of this trial is to assess the efficacy of both ART+MF and CT on the general~     function of the patients with FM. A secondary objective is to assess the effect of these~     therapies on psychological (pain, depression, anxiety, etc.) and biological variables (some~     biomarkers related with inflammation).~      Methods:~        -  Design: Randomized, controlled trial with three arms: a) ART+MF, b) CT and c) Relaxation~          as control intervention.~        -  Sample: A sample (N=60 patients, about N=20 for each arm) will be recruited from primary~          care settings at the city of Zaragoza, Spain.~   "
85014|NCT02454231|"~     The investigators designed a randomized clinical trial (stem cell emergency life threatening~     arteriopathy or SCELTA) to compare the therapeutic efficacy of the auto-transplant of~     enriched circulating EPCs (ECEPCs) with auto-transplant of BM-MNCs. ECEPCs, obtained by~     immunoselection of CD14+ and CD34+ cells, or BM-MNCs, were injected intramuscularly in the~     affected limb of patients with critical limb ischemia (CLI).~   "
85016|NCT02454205|"~     This study aims to evaluate the impact of a new injection-free six-to-nine month treatment~     regimen of linezolid, bedaquiline, levofloxacin, pyrazinamide (PZA) and ethionamide/high dose~     isoniazid (INH) compared to the conventional empiric injection-based regimen of 21-24 months~     treatment. The secondary aim is to determine if other treatment-related outcomes including~     adverse events, adherence to treatment, culture conversion, and cure/completion are~     significantly different in the intervention and conventional arms.~   "
85017|NCT02454192|"~     The purpose of this study is to systematically investigate across health center study sites~     participating in this study the process of adopting, integrating, implementing, and diffusing~     a minimum set of evidence-based interventions for the management of childhood asthma.~     Investigators hypothesized that an intervention that is evidence- and consensus-based (i.e.,~     minimum elements to be integrated into existing practice, dosing of each element) would be~     implemented effectively, as measured by health center performance improvement on child health~     outcomes, health care utilization, and other measures (e.g., avoidable costs).~   "
85018|NCT02454179|"~     Study of the combination of acalabrutinib (ACP-196) and pembrolizumab in subjects with~     advanced head and neck squamous cell carcinoma.~   "
85019|NCT02454166|"~     Background and objective: Stroke, which means sudden onset of cerebral vascular accident. The~     earliest document was found in Neijing. The ancient physicians had different opinions and~     points of view on the etiology and pathogenesis of stroke. Before the Tang and Song dynasty,~     the exopathic wind theory was talked about. And, after then, the endogenous wind theory~     was put forward. While in the Ming dynasty, Zhang Jing-Yue advocated that Stroke is not~     caused by wind etiology'', highlighting the much difference of the thinking. Until nowadays,~     many famous physicians have their own unique way to determine the etiologic factor based on~     differentiation. To be practical, objectivity differentiating and determining the etiologic~     factor of stroke is the foundation of establishing the treatment guidelines. The~     investigators aim to establish the scientific epidemiological standard of traditional Chinese~     Medicine (TCM) syndromes of acute ischemic stroke in Taiwan.~   "
85020|NCT02454153|"~     This is a randomized control trial in people with diabetes and obstructive sleep apnea who~     will be randomly assigned for 3 months to PAP therapy along with healthy lifestyle and sleep~     education or healthy lifestyle and sleep education.~   "
85021|NCT02454140|"~     This study is to determine the maximum tolerated dose (MTD) of five fraction stereotactic~     radiotherapy (SBRT) in pancreatic cancer.~   "
85022|NCT02454127|"~     A single-center randomized trial at an academic medical center in Boston, Mass, of overweight~     or obese adults with known hypertension, dyslipidemia, or fasting hyperglycemia. Participants~     were enrolled starting July 18, 2000, and randomized to 4 popular diet groups until January~     24, 2002.~   "
85023|NCT02454114|"~     HOME FIRST (Home Followed - up with Infection Respiratory Support Team) is an early supported~     discharge scheme. It will enable patients with lower respiratory tract infection (LRTI) to be~     provided with high quality safe, effective, efficient patient centred care, tailored to their~     needs in their own home; aiming to improve the overall experience of the service user,~     improve patient outcomes and reduce hospital length of stay whilst simultaneously reducing~     admission rates, an area of major strategic importance to the NHS.~   "
85024|NCT02454101|"~     To compare the short term risks and benefits of cord milking 5 times toward the neonate with~     delayed cord clamping for 120 seconds in the full term neonate delivered by cesarean section.~   "
85025|NCT02454088|"~     This will be a single-center, investigator-initiated, double-blinded, randomized,~     bilateral-comparison pilot study of injectable Calcium hydroxylapatite with and without~     Triamcinolone acetate for the treatment of volume loss to the dorsum areas of the hands.~   "
85026|NCT02454075|"~     This study will evaluate whether treatment with YF476 is safe and effective in reducing the~     size of type II gastric carcinoid tumours, or limiting the abnormal growth of gastric ECL~     cells, in patients with Zollinger-Ellison syndrome.~   "
85027|NCT02454062|"~     A Phase I, Open-Label, International, Multicenter, Non-Randomized, Dose-Escalating Safety,~     Tolerance and Pharmacokinetic Study of Oral Administration of TAS-114 in Combination with S-1~     in a Twice Daily Schedule for 14 Days in Patients with Advanced Solid Tumors.~   "
85028|NCT02454049|"~     The aim of this study is to investigate wether beetroot juice or sodium nitrate enhances time~     trial performance in Swiss paracycling athletes compared to the ingestion of a placebo~     supplement. Furthermore, the effects of beetroot juice and sodium nitrate on performance will~     be investigated in spinal cord injured and non-injured athletes.~   "
85029|NCT02454036|"~     Baseline self-report outcome measures will be completed and additional assessments will occur~     mid-treatment , post-treatment , 3 months following completion of all sessions, and 6 months~     following completion of all sessions. Patients and therapists will complete the evaluation~     measures in private (at home, in an office).~      At the University of Kentucky Markey Cancer Center, BBI treatment is offered in group and~     individual formats. The course of individual treatment varies and group treatment consists of~     10 1.5-hour weekly sessions in the intensive phase, followed by 2 1.5-hour bi-weekly~     maintenance sessions. Individual treatment is one-on-one. In group treatment, there are~     typically 6-12 patients per group and 1 or 2 therapists. The intervention helps patients to~     learn adaptive coping strategies and how to apply them to daily stressors. Additional content~     discusses use of seeking information, enhancing social support, enhancing body esteem and~     intimacy, and maintaining positive changes.~   "
85030|NCT02454023|"~     Obstructive sleep apnea (OSA) is common after stroke/TIA and, left untreated, is associated~     with recurrent vascular events, poor functional outcomes, and long-term mortality. Despite~     its high prevalence, OSA often remains underdiagnosed after stroke. The purpose of this study~     is to evaluate portable sleep monitors (PSMs) as a broad screening tool for OSA after~     stroke/TIA. The study investigators hypothesize that the screening with PSMs will lead to an~     increase in the diagnosis of treatable OSA after stroke/TIA and an improvement in~     sleep-related and functional outcomes.~   "
85031|NCT02454010|"~     The purpose of this study is to determine the safety and tolerability in subjects who receive~     FF-21101(111In) for dosimetry and FF-21101(90Y) for treatment of advanced solid tumors.~   "
85107|NCT02453009|"~     The aim of this study is to verify if the addition of enzalutamide to docetaxel is able to~     improve the disease control in first line CRPC patients.~   "
85032|NCT02453997|"~     This study investigate mycophenic acid (MPA) pharmacokinetics and pharmacogenomics and their~     impact on the clinical outcomes in lupus nephritis (LN) patients. Lupus nephritis patients~     (both active or inactive) will be recruited. MPA levels will be checked at 1, 2, 4, 8, 10, 12~     hrs after MMF administration by an enzymatic assay upon recruitment, then at 6-months'~     intervals and also when clinically significant events occurred. The MPA levels will be~     correlated with clinical parameters and outcomes. Pharmacogenomics studies will also be~     carried out and correlated with MPA exposure and clinical outcomes.~   "
85033|NCT02453984|"~     By performing a 89Zr-MPDL3280A-PET scan prior to treatment with MPDL3280A, the uptake of the~     tracer in the primary and metastatic tumor lesions and normal organ distribution can be~     evaluated, as well as the use of a 89Zr-MPDL3280A-PET as a complementary tool for patient~     selection in the future.~   "
85034|NCT02453971|"~     The purpose of this study is to evaluate the effects of the German eCHECKUP TO GO (eCHUG-D)~     in students. Compared to the control group subjects who conducted eCHUG-D should have less~     alcohol consumption and less alcohol associated problems after three and six months.~   "
85035|NCT02453958|"~     Evaluation of the utility of a multi-modal assessment tool in distinguishing between~     individuals with and without a history of mild traumatic brain injury.~   "
85036|NCT02453945|"~     The primary purpose of this study is to examine whether a properly fitted support bra on~     females improves their quality of life post-sternotomy. Specifically, does a support bra~     reduce discomfort, pain and wound dehiscence.~   "
85037|NCT02453932|"~     This ongoing study aimed to evaluate the efficacy and safety of Tianzhi granule in mild to~     moderate vascular dementia in a more reasonable design.~   "
85038|NCT02453919|"~     The REgister of cardiovascular COmplications among people living with HIV (RECOVIH) is a~     single hospital registry of adults living with HIV, with one or more other cardiovascular~     risk factor, who undergo cardiac examination at the Cardiac Center of the Saint Antoine~     Hospital. RECOVIH is an observational and prospective, monocentric (institutional) registry,~     with anonymized cardiac, biochemical and associated data collection.~   "
85039|NCT02453906|"~     The investigators will use EEG, structural MRI, and resting-state functional connectivity MRI~     to assess neuronal responses in 28 healthy subjects to different somatosensory stimulations.~   "
85040|NCT02453893|"~     This research is a Randomized, double-blind, risperidone-controlled, multicenter clinical~     study. Chinese subjects with Ischemic Schizophrenia.~   "
85041|NCT02453880|"~     Symptoms of anxiety and depression are common in adolescents and young adults with chronic~     illnesses and are associated with decreased adherence to medical regimens. However, many~     young patients go untreated for anxiety and depression. The purpose of this study is to~     evaluate an online cognitive behavioral therapy (CBT) program in young adults with chronic~     illness. Prior research has shown online CBT to be effective in multiple other populations,~     but to the investigators' knowledge, this is the first study to examine web-based CBT for~     young adults with chronic illnesses.~   "
85042|NCT02453867|"~     Study purpose To establish efficacy and safety of a reduced immunosuppressive therapy with~     tacrolimus once daily for senior (>65 years of age) renal transplant recipients~   "
85043|NCT02453854|"~     A trial comparing Treatment as usual with Motivational Interviewing focussed treatment in the~     'Small Changes' programme.~   "
85044|NCT02453841|"~     This proposed study will assess the hemodynamic effects and measure the systemic absorption~     of topically applied oxymetazoline in patients undergoing functional endoscopic sinus~     surgery, turbinate surgery, or adenoidectomy. These patients will be receiving oxymetazoline~     as standard of care during the surgery.~   "
85045|NCT02453828|"~     Perioperative management decisions must often be made quickly and rely on practitioners~     having relevant facts at hand. During transitions of patient care between anesthesia~     providers, known as handovers, information may not be completely or faithfully~     communicated, consequently impairing the provider's ability to intervene correctly in~     response to subsequent events. Checklists have consistently proven to be effective at~     enhancing communications during handovers, but whether anesthesia checklists improve patient~     outcomes has yet to be proven. The investigators propose to randomize intraoperative~     anesthesia provider handovers to standard practice (no specific format) or to a handover~     checklist presented by a decision-support system in conjunction with the investigators~     electronic record. Specifically, the investigators will test the hypothesis that~     incorporating a largely pre-populated handover checklist into transitions of intraoperative~     anesthesia care decreases a composite of mortality and serious cardiovascular, respiratory,~     gastrointestinal, urinary, and infectious complications.~   "
85046|NCT02453815|"~     Even slight reduction in serious complications related to blood pressure management would~     easily justify the cost and relatively rare complications consequent to arterial catheter~     insertion. However, it seems unlikely that major outcomes will be improved by the presumably~     slight difference in hemodynamic control resulting continuous blood pressure measurement~     rather than measurements at 2-5-minute intervals. There is considerable variation in practice~     and no clear consensus whether arterial lines should be placed or not, especially in ASA 2~     patients undergoing major non-cardiac surgery or ASA-3 patients undergoing moderate to major~     non-cardiac surgery. Clearly, if there is no benefit to outcome, arterial lines, which are~     invasive and costly, should not be placed routinely. The investigators therefore propose to~     test the primary hypothesis that use of arterial catheters decreases the risk of a collapsed~     composite of in-hospital mortality, re-admissions, MINS, AKI, stroke, respiratory and wound~     healing and gastro-intestinal complications after non-cardiac surgery.~      Secondarily, the investigators propose to test the hypotheses that arterial catheter use: 1)~     decreases the duration of hospitalization; 2) increases blood gas, electrolyte, and~     coagulation testing; 3) increases induction-to-incision time; and, 4) increases cost-of-care~     (supplies,, blood tests, and induction-to-incision time).~   "
85047|NCT02453802|"~     The purpose of the study, therefore, is to conduct a prospective randomized controlled trial~     to investigate the blood-conservation effect of TXA in different TKA patients groups with~     rivaroxaban for VTE prophylaxis, first group by topical application, second group by infusion~     and a third group of placebo and observe whether there is difference in the occurrence of~     venous thromboembolism in those patient groups by venographic study~   "
85049|NCT02453776|"~     Infliximab (IFX) is highly effective in inducing and maintaining remission in patients with~     inflammatory bowel disease (IBD). However, a large proportion of patients will eventually~     lose response to IFX. Therefore, strategies to improve the outcome of maintenance treatment~     with IFX are required. Retrospective analyses suggest that adjusting IFX treatment in order~     to achieve IFX trough levels (TL) above a well-defined therapeutic threshold will improve the~     outcome of IFX treatment.~   "
85050|NCT02453763|"~     The purpose of this research study is to measure current flow inside the head using magnetic~     resonance imaging (MRI). The data from this study will be used to map the current flow caused~     from the electrical stimulation inside the head. The methods develop will be used to map and~     better control delivery of the current for electrical stimulation to modify a psychiatric~     condition such as depression; or other conditions such as epilepsy, Parkinson's disease or~     autism.~   "
85051|NCT02453750|"~     We propose to examine Congenital Diaphragmatic Hernia (CDH) patients for evidence of airway~     inflammation as a first step to characterize the reported bronchodilator responsiveness.~     Airway biopsy studies are invasive and thus we propose to perform induced sputum studies to~     document the amount and type of inflammation present. Another ancillary non-invasive measure~     of airway inflammation that we will use is exhaled nitric oxide (NO). The primary objective~     of this study is to determine if CDH patients have any evidence of airway inflammation. The~     hypothesis of this study is that children with CDH do not have evidence of airway~     inflammation associated with bronchodilator responsiveness. Based on this information,~     treatment for CDH patients will hopefully be more accurate and appropriate for their specific~     needs.~   "
85052|NCT02453737|"~     This is an open label phase II study to determine the safety and efficacy of a novel 3~     fraction daily dosing regimen for accelerated partial breast irradiation (APBI) for early~     invasive and noninvasive breast cancer. The three techniques utilized are recognized as~     standard options for the delivery of APBI, and there is no evidence that either technique is~     superior or inferior to any other. The APBI technique utilized will be at the physician's~     discretion and will be based on technical considerations, availability at the treating~     radiation facility, insurance coverage, as well as patient preference.~   "
85053|NCT02453724|"~     The purpose of this study is to investigate if diagnostic ultrasound as it is routinely~     performed in humans causes lung hemorrhage significant enough to appear on thoracic CT. The~     investigators' hypothesis is that diagnostic lung ultrasound will not cause lung hemorrhage~     in humans. Damage to the lung in animal models has been shown to be mechanical rather than~     thermal in nature and evidence suggests that this injury is likely not from inertial~     cavitation but from alveolar resonance. Models of the alveolar resonance theory predict that~     hemorrhage should not happen in adult human lungs if the ultrasound frequency is higher than~     1.69 MHz and mechanical index (MI) is less than 1.9 which is maintained with standard~     scanning protocol for thoracic ultrasound. A previous human study showed no gross macroscopic~     lung hemorrhage in patients undergoing transesophageal echocardiography with pressures of 2.4~     MPa and MI 1.3 with exposure durations ranging 7-68 minutes.~      The investigators propose to perform a routine lung ultrasound exam on patients who are~     scheduled to undergo chest computed tomography evaluation for pulmonary embolus as part of~     their routine care. The ultrasound will be performed immediately prior to CT imaging and~     markers will be placed on the patients chest to ensure the correct lung tissue is being~     evaluated. There will be two sham markers so the radiologist will be blinded to which tissue~     had ultrasound applied and which did not. The CT scan will then be evaluated per routine and~     also to see if there are signs of microscopic or macroscopic hemorrhage under the skin~     markers.~   "
85054|NCT02453711|"~     This trial is conducted globally. The aim of this trial is to investigate safety and efficacy~     of once-daily semaglutide in obese subjects without diabetes mellitus.~   "
85055|NCT02453698|"~     The aim of this study is to investigate the effects of Methylphenidate on neural activity~     underlying inhibitory control and error monitoring in healthy adults. More specifically, the~     investigators aim to establish the baseline modulatory effect of Mehtlylphenidate on~     bottom-up and top-down aspects of these cognitive processes. This work will further our~     understanding of Attention Deficit Hyperactivity Disorder, Methylphenidate, and executive~     functioning.~   "
85056|NCT02453685|"~     This trial is conducted globally. The aim of this trial is to compare stepwise insulin~     intensification of biphasic insulin aspart (BIAsp) 30 and basal-bolus therapy with insulin~     glargine and insulin aspart in insulin naïve type 2 diabetic patients inadequately controlled~     on oral anti-diabetic therapy.~   "
85057|NCT02453672|"~     Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of~     Bevacizumab~   "
85058|NCT02453659|"~     The long-term goal of this program of research is to develop and disseminate an efficacious,~     group-based distress tolerance treatment for weight concern (DT-W) that will significantly~     increase smoking cessation rates among women. The objective of this project is to conduct a~     preliminary randomized controlled trial (RCT) (N = 60) comparing DT-W to a Health Education~     (HE) comparison intervention, in which both groups also receive standard behavioral smoking~     cessation treatment (ST) including counseling and transdermal nicotine patch (TNP), and~     examine potential mechanisms that may underlie the efficacy of DT-W in improving smoking~     outcomes at 1-, 3-, and 6-month follow-ups.~   "
85059|NCT02453646|"~     A U.S. multi-centre post approval registry to analyse the CRBSI rate in patients with the~     NexSite HD Catheter for long term vascular access for hemodialysis.~   "
85060|NCT02453633|"~     The project will be done at the ear, nose and throat outpatient department at Lovisenberg~     Diakonale Hospital (LDS) in 2015-2016. About 12% of patients with appointments at the~     surgical outpatient clinic at LDS do not attend their appointment even after receiving both~     letters and shot message service (SMS) reminders. Persuasion theory suggests that the SMS~     reminders may be more effective if the text appeals more to the patient's feelings. The~     project is designed as a randomized controlled trial in which the control group receives the~     standard text that has neutral content and the intervention group receives a more~     emotion-based SMS reminder. The aim is to determine whether the more emotional text reduces~     the proportion of patients who do not show up for their scheduled appointment at the surgical~     outpatient clinic.~   "
85108|NCT02452996|"~     In this clinical study, the safety and tolerability of GNbAC1 as a treatment for MS patients~     will be evaluated in healthy male volunteers.~   "
85061|NCT02453620|"~     This phase I trial studies the side effects and best dose of entinostat and nivolumab when~     given together with ipilimumab in treating patients with solid tumors that have spread to~     other places in the body and usually cannot be cured or controlled with treatment~     (metastatic) or that cannot be removed by surgery (unresectable) or human epidermal growth~     factor receptor 2 (HER2)-negative breast cancer that has spread from where it started to~     nearby tissue or lymph nodes or other parts of the body. Entinostat may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth (locally~     advanced/metastatic). Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere~     with the ability of tumor cells to grow and spread. Giving entinostat and nivolumab together~     with ipilimumab may be a better treatment in patients with solid tumors.~   "
85062|NCT02453607|"~     In this research proposal, the investigators will focus on methods to optimize the~     therapeutic response to anti-TNF antibodies, by determining a correlation of 6-mp metabolite~     levels with IFX trough levels, anti-IFX antibody levels and clinical response. The study will~     also evaluate (in vitro) the possible impact of vitamin D on the interaction of IFX with~     dendritic cells in both healthy subjects and patients with Crohn's disease (proliferation,~     maturation, cytokine profile, apoptosis, gene expression).~   "
85063|NCT02453594|"~     This is a study of pembrolizumab (MK-3475) for participants with relapsed/refractory~     classical Hodgkin Lymphoma (RRcHL) who: 1) have failed to achieve a response or progressed~     after autologous stem cell transplant (auto-SCT) and have relapsed after treatment with or~     failed to respond to brentuximab vedotin (BV) post auto-SCT or 2) were unable to achieve a~     Complete Response (CR) or Partial Response (PR) to salvage chemotherapy and did not receive~     auto-SCT, but have relapsed after treatment with or failed to respond to BV or 3) have failed~     to achieve a response to or progressed after auto-SCT and have not received BV post auto-SCT.~      The primary study hypothesis is that treatment with single agent pembrolizumab will result in~     a clinically meaningful overall response rate.~   "
85064|NCT02453581|"~     A single centre, open, controlled study using Blood Stage Plasmodium falciparum challenge~     inoculum (BSPC) as a model to assess the effectiveness of three dose levels of the~     experimental anti-malarial product, OZ439.~   "
85065|NCT02453555|"~     This trial will compare the use of fiixed dose conbination of empagliflozin and linagliptin~     to linagliptine alone in patient with type 2 diabetes mellitus~   "
85066|NCT02453542|"~     Background~      The treatment of haemophilia A and B has been revolutionized by the use of factor~     concentrate, both as prophylaxis and to treat bleeding episodes (on-demand treatment).~     However, despite its advantages, repeated treatment with factor concentrate can lead to~     development of inhibitors (antibodies) towards the coagulation factor in the concentrate.~     Another patient group in which the bleeding symptoms are difficult to treat because of~     inhibitors towards coagulation factors, most commonly FVIII, is patients with acquired~     haemophilia. Patients with high antibody titers exhibit a deficient or no response to factor~     concentrates and usually need treatment with bypassing agents, namely factor eight inhibitor~     bypassing agent (FEIBA®, Baxter) och recombinant activated factor VII (rFVIIa, Novo-Seven®,~     Novo Nordisk). The effect of the treatment cannot be accurately monitored by traditional~     coagulation tests.~      The aim of the study is to evaluate the utility of the global haemostatic methods in patients~     with haemophilia with inhibitors. The objective is to improve the monitoring of the treatment~     effect and thus increase the safety of the patient and the effectiveness of the treatment.~      Patients and methods~      Patients~      The primary cohort will consist of fifteen patients with inherited haemophilia with~     inhibitors as well as five adult patients with acquired haemophilia who are followed up at~     the Coagulation Department of the Karolinska University Hospital, Stockholm, Sweden.~      Blood samples will be collected from those patients at specific time points (see Design of~     the study) during the course of two years (for each patient). The treatment (type, dose,~     duration) will be determined by the treating physician.~      Methods (selection)~        -  Thrombin generation (Calibrated Automated Thrombogram, CAT® and a commercial kit from~          Siemens®).~        -  Overall haemostatic potential (OHP)~      Design of the study~      Timeframe for blood sampling: i) baseline (inclusion in the study), and ii) prior and after~     administration of bypassing agents to either treat bleeding symptoms or before an invasive~     procedure or as prophylaxis.~      Data analysis~      The variations in coagulation markers measured as described above (Methods) will be~     associated to the clinical symptoms (bleeding), the level of coagulation factors (if~     measurable) and the titers of the inhibitors.~   "
85067|NCT02453529|"~     This is a Phase 1, multiple dose, open-label pharmacokinetic study conducted in healthy adult~     male and female subjects.~      Subjects will receive 3 oral doses of WCK 4873 administered once-daily starting on Day 1.~     Blood collection for determining plasma WCK 4873 concentrations will be conducted within 15~     minutes prior to and at 1, 2, 3, 4, 6, 9, 12, and 24 hours after the first dose of WCK 4873.~     The 24 hours post-dose sample after the first dose will be collected prior to Day 2 dosing.~     Blood samples for determining plasma WCK 4873 concentrations will also be collected within 15~     minutes prior to and at 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours after the third dose. Each~     subject will undergo one standardized bronchoscopy with bronchoalveolar lavage (BAL) in the~     outpatient bronchoscopy suite at 3, 6, 9, 12, 24 or 48 hours after the third oral dose of WCK~     4873. Subjects scheduled for bronchoscopy at 48 hours will also have blood sample drawn for~     determining plasma WCK 4873 concentrations at 48 hours after the third dose.~      Safety will be assessed throughout the study by adverse event monitoring, clinical laboratory~     tests (including liver function tests), ECG, physical examination and vital sign monitoring.~     Subjects will discontinue study drug administration in the event of AST/ALT elevation of~     greater than 3 times the upper limit of normal.~   "
85068|NCT02453516|"~     Surgery for breast cancer is associated with significant pain. The serratus nerve block~     targets the interfascial plane either below or above the serratus muscle, blocking thereby~     the lateral cutaneous branches of the intercostal nerves. The purpose of this randomized~     controlled double-blinded study is to see whether the addition of a serratus nerve block to a~     general anesthesia results in a better postoperative pain control in patients undergoing~     surgery for breast cancer.~   "
85069|NCT02453503|"~     Introduction :Oral lichen planus (OLP) is one of the most common disorders of the oral cavity~     which is basically a chronic and inflammated mucocutaneous .There is no cure for OLP~     currently. The main focus of treatment is to reduce the duration and severity of the~     symptoms. This study was designed to determine and compare the parameters of improvement in~     patient symptoms and lesions caused by oral lichen planus by using triamcinolone acetonide~     mucoadhesive film and licorice mucoadhesive film.~      Methods and materials :The study was randomized by double-blind clinical trial . Patients~     with symptomatic OLP who referred to the Oral Medicine School of Dentistryin Medical Sciences~     in Isfahan University participated voluntarily. The patients were divided into two groups~     that were including 30 samples in each group. The first group was treated with triamcinolone~     mucoadhesive film and the second group were treated with licorice mucoadhesive film. Data~     were analyzed by using the Mann-Whitney test and t-test in SPSS software.~   "
85109|NCT02452983|"~     This study will investigate the effects of sertraline in people with low-risk myelodysplastic~     syndrome (MDS). It is hoped that sertraline will decrease disease progression and reduce the~     need for blood transfusions.~   "
85072|NCT02453464|"~     This is an open-label, multicenter, dose-escalation study designed to assess the safety,~     tolerability, and pharmacokinetics of Humanized Anti-VEGF Monoclonal Antibody (Sevacizumab)~     Injection in combination with FOLFIRI in patients with previously treated metastatic~     colorectal cancer. This study includes two stages. Stage 1 is the dose-escalation stage. Once~     the maximum tolerated dose (MTD) of Sevacizumab has been established, additional patients~     will be enrolled in the cohort-expansion stage (Stage 2).~   "
85073|NCT02453451|"~     Patients received a MitraClip procedure because of a leakiness of their mitral valves. During~     this procedure the atrioventricular valves were stuck together permanently via a clip which~     leads to a reduction of leakiness. As a result of this procedure a small hole remains at the~     cardiac septum which is called an atrial septal defect (ASD). In most cases the hole will~     close after a few weeks or months, but in many other cases not. Until now there is no exact~     data about the effect of this hole on the filling pressure in the heart or on the blood flow~     behaviour. So the aim of this study is a precise analysis of the blood flow mechanics during~     and after the MitraClip procedure to identify criteria to get more informations for a better~     strategy and regulation of the MitraClip procedure.~   "
85074|NCT02453438|"~     The MoodNetwork, a patient-powered research network (PPRN), is one of 18 PPRNs participating~     in Patient-Centered Outcomes Research Institute's (PCORI) PCORnet network. Its objective is~     to improve the nation's capacity to conduct comparative effectiveness research that reflects~     questions of greatest importance to patients and other stakeholders. A robust data~     infrastructure will be built that, in phase one, allows participants to contribute data,~     including those from participant questionnaires, visualize their own health information in~     intuitive and helpful ways, and share their aggregated de-identified health information~     within and outside of the Network.~   "
85075|NCT02453425|"~     The purpose of this study is to evaluate renal effects of 3 different levels of mean arterial~     pressure in early case of septic shock. In 8 patients diagnosed with early septic shock, we~     will adjust mean arterial pressure (MAP) to three different levels, using norepinephrine. At~     each level of MAP, central and renal hemodynamics and oxygenation states will be measured.~     Analysis will be made to describe the pathophysiology at MAP 75 mmHg, and then to evaluate at~     which MAP renal function and oxygenation is least affected negatively.~   "
85076|NCT02453412|"~     Patients suffering from end-stage renal disease (ESRD) are dependent on renal replacement~     therapy (dialysis). The majority of dialysis is facilitated by hemodialysis. For hemodialysis~     a vascular access is necessary, preferable an arteriovenous fistula (AVF) in which a vein is~     directly anastomosed to an artery. In order to use the AVF for hemodialysis three criteria~     have to be met; the minimal flow over the AVF is 600 mL/min, the diameter is at least 6 mm,~     and the AVF is located less than 6 mm under the skin. Unfortunately, approximately half of~     the patients (50%) are confronted with an AVF that does not meet these criteria; the so~     called non-maturation or primary failure. In case of non-maturation the AVF is not only~     unusable for dialysis, but also requires reinterventions on short- and long-term. Firstly to~     mature the AVF, and secondly, when the AVF is matured, to keep the vascular access. Using a~     computational simulation postoperative flow can be predicted. Based on patient-specific~     duplex measurements, the model can calculate the flow that can be expected following vascular~     access surgery for all AVF configurations; fore- or upper arm. These calculations lead to an~     advice which configuration is indicated; a flow that exceeds 600 mL/min, leading to~     maturation. Potentially the aforementioned 50% of non-maturation can be reduced. The patient~     then has an adequate vascular access and reinterventions are adverted, resulting in a~     decrease of costs, hospital demand, and an increase of the patients' quality of life. When~     the expected reduction of non-maturation is confirmed, the computational tool can be offered~     to other hospitals.~   "
85077|NCT02453399|"~     This study will evaluate transcutaneous electro stimulation device developed by Siano for~     adequacy, safety and efficacy for the treatment and/or prevention of migraine pain for~     migraine sufferers.~   "
85078|NCT02453386|"~     Phase 3, international, multicenter, randomized, double-blind, placebo-controlled,~     parallel-group, 3-arm safety and efficacy study (Part A) with an open-label phase (Part B).~   "
85079|NCT02453373|"~     The aim of this study is to assess the feasibility of using the Life Recovery Systems~     ThermoSuit Device to induce therapeutic hypothermia (32-34°C) in victims of ischemic stroke.~     This feasibility clinical study will enroll a total of 30 patients with acute ischemic stroke~     at two clinical centers. Subjects will receive hypothermia plus conventional therapy (such as~     IV-tPA and/or neurothrombectomy therapies if indicated). Endpoints will include feasibility~     of cooling, adverse events, and neurological recovery in comparison with matched historical~     controls.~   "
85080|NCT02453360|"~     Total knee arthroplasty (TKA) can be associated with a large amount of postoperative pain.~     This pain can oftentimes be severe enough to limit participation in physical therapy and~     ultimately delay discharge resulting in increased cost. Several strategies have been~     developed in an effort to decrease postoperative pain following TKA while maintaining lower~     extremity strength and maximizing participation in physical therapy. Recently, adductor canal~     blockade has gained popularity as it is reported to provide analgesia to the anterior knee~     without resulting in significant quadriceps muscle weakness. However, few studies have~     carefully evaluated the impact of volume of injection of local anesthetic into the adductor~     canal on motor weakness or pain control. The ability to achieve similar pain control with~     decreased volumes of local anesthetic would allow the surgery team to apply more local~     anesthetic to posterior knee structures. Decreased volumes of local anesthetic may also be~     associated with a decreased risk of local anesthetic toxicity. This study aims to carefully~     evaluate this relationship using a physical therapy evaluation method that relies on both~     motor strength and pain control. In addition, the investigators hope to carefully evaluate~     motor strength using a novel method of strength measurement in an effort to further evaluate~     the impact of volume of injection of local anesthetic into the adductor canal on motor~     strength.~   "
85081|NCT02453347|"~     The primary aim of this proposed study is to gather preliminary data for CES use in treating~     PTSD and anxiety symptoms in OEF/OIF Veterans with PTSD and a history of TBI.~   "
85082|NCT02453334|"~     Phase III, multicenter, randomized, double-blinded, prospective study with two parallel~     treatment groups. Patients who present to the hematologist/oncologist and satisfy all~     inclusion and exclusion criteria will be eligible for participation in this 18-week study.~   "
85083|NCT02453321|"~     Recently, several articles have suggested or reported that Adductor Canal Blocks (ACBs) offer~     adequate or equal analgesia and may promote better performance in early rehabilitation~     following Total Knee Arthroplasty (TKA) when compared to the more commonly used Femoral Nerve~     Block (FNB). A common feature of these studies has been the use of moderate to high~     concentration local anesthetics (e.g. 0.2% or 0.5% Ropivacaine respectively) which when~     injected by a large motor nerve will inevitably cause weakness. However, the practice at our~     institution has long been a continuous femoral nerve block (CFNB) with a lower concentration~     local anesthetic (0.0625% Bupivacaine). Over the past several years the investigators have~     performed several thousand CFNBs using this technique which has offered the advantage of~     minimal motor weakness and adequate analgesia.~      The primary goal of this study is to determine if our established practice of using a low~     concentration continuous FNB inserted about 5cm caudal to the groin crease (the apex of the~     femoral triangle) using a low infusion rate of 2ml/hr is comparable to the emerging practice~     of inserting a Continuous Peripheral Nerve Block (CPNB) in the anatomic adductor canal (AC) -~     infusing at 4ml/hr. A secondary goal is to study the effect of cumulative volume of local~     anesthetic infused through a FNB when at a rate of 2ml/hr compared to a rate of 4ml/hr in the~     48-hour postoperative period.~      Definitions of the location of the adductor canal are debated heavily in literature, but they~     seem to agree that the middle 1/3 of the thigh contains the proximal AC while the distal 1/3~     of the thigh contains the adductor hiatus - the terminal end of the AC. Our study will~     require placement of the continuous ACB no more distal than 20cm cephalad to the superior~     pole of the patella due to placement prior to surgery and the need to keep the dressing out~     of the operative field. The CACB catheter will also not be placed any more proximal than 20cm~     distal to the ASIS. In addition to other exclusion criteria, these measurements will create~     an exclusion for patients with an iliac-to-patella distance less than 40cm. Iliac to Patella~     distance (IPD) will be measured at the pre-operative interview on the day of surgery with a~     measuring tape. External palpable landmarks of the Anterior superior iliac spine and the~     superior pole of the patella will be used.~      The primary outcome is based upon the ability to perform rehabilitation exercises~     postoperatively to the extent that criteria for discharge can be met. The primary outcome~     measured is the time at which a patient gains the ability to successfully perform a 75-feet~     unassisted walk. On the Day of Surgery (DOS), prior to any walking attempt, a secondary~     outcome measure will be to perform a 5-second sustained straight leg raise. Other secondary~     outcomes will be the number of days admitted prior to discharge, and average pain scores on~     DOS, Postoperative Day (POD) #1, and POD#2. The Day of discharge will also be used as a~     secondary outcome. Earlier discharge is becoming a goal of almost all healthcare systems to~     minimize costs.~   "
85084|NCT02453308|"~     This study is an open-label randomised trial comparing standard ACT treatment with matching~     triple artemisinin-based combination therapies (TACTs), evaluating efficacy in safety and~     tolerability. The estimated total sample size is 2040 patients from 16 sites in Asia and 1~     site in Africa. There are 2 arm study groups that have 2 treatment arms each.~      Study group A:~      A.1: Artemether-lumefantrine for 3 days. versus: A.2: Artemether-lumefantrine for 3 days plus~     Amodiaquine for 3 days.~      Study group B:~      B.1: Dihydroartemisinin-piperaquine for 3 days. versus: B.2: Dihydroartemisinin-piperaquine~     for 3 days plus Mefloquine hydrochloride for 3 days.~      Study group C:~      C.1: Artesunate-mefloquine for 3 days versus: C.2: Dihydroartemisinin-piperaquine for 3 days~     plus Mefloquine hydrochloride for 3 days.~      According to the WHO guideline, all patients except for children under the age of 1 year or a~     weight below 10 kilograms will also be treated with a single dose of low dose primaquine.~   "
85085|NCT02453295|"~     The specific objectives and research questions of the proposed study are:~        1. a. Administer a group rehabilitation intervention to address loss and foster hope in 30~          participants with upper and lower limb SLC --15 in an intervention group (IG), 15 in a~          control group (CG) at each of two research sites (Montreal, QC and Saint John, NB) for a~          total sample size of 60. Data about its impact will be collected by means of~          audiorecording 8 intervention workshops at each site and administering questionnaires~          (multiple timepoints).~           b. Test the intervention - Main hypothesis: The intervention group will show~          improvements in psychosocial well-being.~        2. Assess feasibility (e.g., review our accrual strategies, randomization of participants,~          and data collection) via the completion of process logs.~   "
85086|NCT02453282|"~     This is a randomized, open-label, multi-center, global, Phase III study to determine the~     efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy~     versus platinum-based SoC chemotherapy in the first-line treatment of patients with epidermal~     growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type locally advanced~     or metastatic NSCLC~   "
85087|NCT02453269|"~     The purpose of this study was to evaluate the outcome of a 1-year transdisciplinary program~     against childhood obesity.~   "
85088|NCT02453256|"~     This study will assess the efficacy and safety of tocilizumab compared with placebo in~     participants with SSc across approximately 120 planned global study sites. The study will~     consist of a 48-week, double-blind, placebo-controlled period followed by a 48-week~     open-label treatment period. Participants will be assigned, in a 1:1 ratio, to double-blind~     treatment with active tocilizumab or matching placebo. In the open-label period, eligible~     participants from either arm may receive active tocilizumab.~   "
85089|NCT02453243|"~     Many patients at risk for suicide are discharged from the ED with little or no intervention.~     Evidence-based suicide prevention interventions, like universal screening and safety planning~     should be adopted in clinical practice to help prevent suicidal behavior. This study will~     test the long-term sustainability of the nurse administered universal screening implemented~     in the original ED-SAFE study. Also, the investigators will test what impact implementing a~     new personalized Safety Planning Intervention guided by Lean has on suicide composite~     outcomes.~      The ED-SAFE-2 will use a stepped wedge design where the original eight ED-SAFE sites will~     collect quantitative and qualitative data during the three phases: Baseline, Implementation,~     and Maintenance. Using this data, as well as data from the original ED-SAFE study, the~     ED-SAFE-2 will examine both within and between site differences for existing screening~     practices and new safety planning procedures. Most of the data collection on outcomes will be~     done by retrospective chart review.~      The Safety Plan Intervention will be adopted into routine clinical care for patients who~     screen positive but are set to be discharged. Each step is presented by the clinician and the~     responses are recorded on a templated form. After completion of the safety plan, the~     clinician helps the patient identify the most helpful aspects of the plan, ascertains the~     likelihood of actually using it, and addresses any potential barriers to use. The patient~     keeps the safety plan to use as a reminder during times of escalating distress or crisis.~      A Lean Implementation Strategy will be used to ensure that adoption of the intervention is~     fully supported vertically and horizontally within the organization, infrastructure is built~     that supports the efforts, and that the protocols fit naturally within roles,~     responsibilities, and clinical flow.~      Consistent with the RFA's emphasis, the intervention target will be the clinician's behavior~     of safety planning. All emergency mental health and nursing personnel at the sites will be~     trained on safety planning, and Lean will be used to help ensure the safety planning is being~     implemented properly and consistently. The mechanisms of action of the combination of the~     safety planning training and Lean will be studied, allowing the team to establish both the~     effect the intervention has on the intervention target but also on the mechanisms of action~     comprised of departmental culture change and infrastructure support.~   "
85090|NCT02453230|"~     Since the 1960's, perinatal mortality in the United States has been declining at a steady~     rate. This decline has thought to be the result of improved surveillance of normal and~     abnormal fetal behavior and using that information to determine those babies at risk for~     stillbirth.~      There are many tools available for surveillance. One of these tools, the bio-physical profile~     (BPP), incorporates a non-stress test (NST) with ultrasound assessment of fetal behavior .~     This test has been used for about the last 30 years with good safety and efficacy. The~     ultrasound evaluation includes monitoring fetal breathing, fetal gross and fine movement and~     amniotic fluid evaluation. NST and BPP have been found to have similar ability to predict~     fetal well-being, with similar safety and ease of performance. Several studies have observed~     the effect of sound as well as light on the NST and have found that it can shorten testing~     time without altering its ability to be interpreted properly or affecting fetal safety.~     However, similar studies have not been done with the BPP. Light stimulation has been proven~     to be safe for both the mother and the fetus with no harm having been demonstrated when used~     with NST.~   "
85091|NCT02453217|"~     The investigators programme of research will evaluate an existing physical health care~     screening intervention with the aim of helping Community Psychiatric Nurses (CPN) to improve~     the physical health wellbeing of people with a SMI.~      This pilot clustered randomised controlled trial aims to establish the potential efficacy and~     acceptability of the Chinese Health Improvement Profile (CHIP) in improving the physical~     health of people with severe mental illness.~   "
85092|NCT02453204|"~     Research has shown that reducing the time spent sitting can reduce the risk of many diseases,~     such as diabetes and heart disease, and improve health. It is estimated that many older~     adults typically spend 70% of their waking day sitting, but little is known about whether~     reducing sitting promotes health and well-being in this age group. The aim of this research~     is to investigate the health effects of reducing sitting time by replacing it with short~     periods of standing or walking in adults over the age of 65.~   "
85093|NCT02453191|"~     The purpose of this research study is to determine the safety and tolerability of talimogene~     laherparepvec when combined with radiation therapy.~      Approximately 32 people will take part in this study conducted by investigators at the~     University of Iowa.~   "
85094|NCT02453178|"~     Although exercise is known to delay cognitive decline and decrease our risk of Alzheimer's~     Disease, there is a lack of understanding of how exercise protects the aging brain. The~     proposed research takes a novel approach to this problem by testing the concept that there~     are acute, direct effects of exercise in the same brain regions that are affected by chronic~     exercise training. If the investigators are successful, the acute paradigm will allow us to~     determine the critical exercise parameters that modulate brain function in humans using only~     a single exercise dose.~   "
85095|NCT02453165|"~     Post-hysterectomy vaginal cuff dehiscence is a rare but threatening complication.~      The investigators will compare transvaginal versus laparoscopic closure of the vaginal vault~     at the end of a total laparoscopic hysterectomy, in order which of these two modalities of~     suturing is associated with a lower risk of dehiscence.~   "
85096|NCT02453152|"~     This study is a longitudinal study evaluating the severity and progression of respiratory~     muscle function in patients with X-Linked Myotubular Myopathy (XLMTM) aged 0-14.~   "
85097|NCT02453139|"~     Obesity, known to be associated with a pro-inflammatory, pro-thrombotic humoral milieu,~     confers a worse prognosis in prostate cancer (PrCa). Circulating tumour cells (CTCs) are~     identified in the blood in advanced cancer. Their quantitation provides prognostic~     information. Cloaking of CTCs by adherent platelets impedes natural killer (NK)-cell~     clearance of CTCs from the circulation, enhancing metastatic spread. NK-cell function in~     blood and in solid organs is quantitatively and qualitatively reduced in obesity. Platelet~     cloaking may be enhanced in obesity due to the pro-inflammatory, pro-thrombotic state, and~     may be a mechanism for worse cancer-specific outcomes in this group. Obesity and its~     biochemical effects may be influenced by lifestyle changes such as exercise. Physical~     activity reduces levels of systemic inflammatory mediators and so an aerobic exercise~     intervention may represent an accessible and cost-effective means of ameliorating the~     pro-inflammatory effects of obesity. The ExPeCT trial will determine if a prescribed exercise~     intervention can ameliorate the degree of platelet cloaking in obese and non-obese men with~     advanced prostate cancer.~   "
85098|NCT02453126|"~     This protocol addresses a central hypothesis that fibrostenotic Eosinophilic Esophagitis~     (EoE) is characterized by abnormal esophageal structure and compliance compared to non~     fibrostenotic EoE and that distinctive cellular and molecular profiles predict the~     fibrostenotic phenotype. This study aims to define and assess the changes that occur in the~     structure and dynamics of the esophageal wall in pediatric Eosinophilic Esophagitis along~     with characterizing the histologic and molecular patterns in fibrostenotic EoE.~   "
85099|NCT02453113|"~     The purpose of this is that the researcher can use low power Near Infrared laser treatment~     non-painful and non-damaging dose to changes the skin properties.The researcher can prove~     that signaling and a significant increase in the number of skin cells in skin tissue exposed~     to the laser can improve the human skin immune system to help improve human body response to~     vaccines.~   "
85100|NCT02453100|"~     An intervention consisting of group and home based exercise will be used over 6 months to~     assess whether this is helpful in managing urinary incontinence in elderly village women in~     Bangladesh. This intervention, supplemented by education about managing incontinence, will be~     used in half the villages in the trial. In the other half women will receive only the~     education component.~   "
85101|NCT02453087|"~     This open-label, multicenter, Phase 1/1b study will evaluate the safety, tolerability, and~     pharmacokinetics of increasing doses of DCDS0780A in participants with relapsed or refractory~     B-cell non-Hodgkin's lymphoma. In the combination portion of the study, the safety and~     tolerability of DCDS0780A in combination with rituximab or obinutuzumab will be assessed.~   "
85102|NCT02453074|"~     The purpose of this study is to design and test the feasibility of a system to survey~     patients regarding the outcome of acute care visits and to report back to the healthcare~     providers.~   "
85103|NCT02453061|"~     In the study the investigators plan to include 100 early affected HD patients (5 ≤ UHDRS ≤~     40) in a randomized, double-blind, controlled study in 2 centers (France and the~     Netherlands). Patients will receive either triheptanoin at 1g/kg of body weight per day (n =~     50), or a control oil (n = 50) at 1g/kg of body weight per day for 6 months followed by an~     open label phase using triheptanoin for another 6 months. Efficacy of triheptanoin will be~     evaluated by measurements of caudate volume using volumetric magnetic resonance imaging and~     brain energy metabolism as evaluated by the ratio of inorganic phosphate/phosphocreatine,~     during visual stimulation, using 31P-MRS. Clinical improvement will be evaluated by UHDRS,~     TFC, and PBA-S scores as well as performance on the neuropsychological battery; patient~     quality of life will be evaluated with qualitative research methods after 6 months and with~     the SF-36 questionnaire before and after treatment; biological tolerance and compliance will~     be evaluated by routine biochemical blood tests, plasma and urine measurements of~     triheptanoin oil derivatives and patient report.~   "
85104|NCT02453048|"~     This study evaluates the safety and immunogenicity of a higher dose formulation of a new live~     attenuated vaccine, BPZE1, intended to prevent Bordetella pertussis nasopharyngeal~     colonization and pertussis disease, and investigates whether higher doses of BPZE1 induce the~     live vaccine to colonize subjects' nasopharynx. The study is a Phase Ib (high dose), single~     centre, dose-escalating, placebo-controlled study of the live attenuated B. pertussis strain~     BPZE1 given as a single intranasal dose to healthy adult volunteer.~   "
85105|NCT02453035|"~     The X-Pand Registry is intended to facilitate analysis of acute & long-term safety as well as~     treatment outcomes with DESolve in patients with CAD.~   "
85106|NCT02453022|"~     The current study will help to increase our understanding of the pharmacokinetics (PK) of~     danirixin. The primary objective of the study is to estimate the relative bioavailability of~     danirixin Hydrobromide (HBr) tablet, when compared to danirixin free base (FB). Safety and~     tolerability information for oral administration of danrixin HBr tablets in elderly subjects~     will also be obtained. Secondarily, this study will evaluate effect of food on PK of~     danirixin HBr, effect of gastric acid suppression, and within-subject PK variability of~     danirixin HBr. The outcome of this study will contribute to the selection of the most~     appropriate formulation/dosing regimen for future studies.~      This is an open-label, 5-period crossover study. Study will be conducted in 18 healthy~     elderly subjects. Screening will occur within 42 days prior to Day 1 of period 1. The~     Treatment Periods will be separated by a washout period of a minimum 5 days. Follow-up will~     be done within 3 to 10 days post last dose.~   "
85110|NCT02452970|"~     The purpose of this study is to see if the investigational drug, RRx-001, an epigenetic~     agent, which turns on a number of beneficial genes that the tumor has silenced, can~     resensitize the tumor(s), in other words make it/them re-respond to gemcitabine and~     cisplatin, which, hopefully, will translate to a longer lifespan. The name of the open-label~     study, which means that patients will know what treatments they are receiving, is EPIC, a~     hybrid or combination of EPIgenetic for the mechanism of action of RRx-001 and~     Cholangiocarcinoma.~      The study treatment is divided into two stages. During the first stage, patients will receive~     RRx-001, which is administered intravenously weekly, for a fixed time period of six weeks. At~     that time the second stage starts in which cisplatin and gemcitabine are reintroduced for as~     long as the tumors respond to them to determine whether resensitization has occurred.~      The primary objective of this clinical trial is to evaluate the progression-free survival~     (PFS) of patients at 9 weeks after the reintroduction of gemcitabine and cisplatin.~   "
85111|NCT02452957|"~     The aim of this observationnal post-marketing study is to provide additional information on~     the safety and effectiveness of Simpliciti™ system at 24 months post-shoulder arthroplasty ,~     in usual surgical practice.~   "
85112|NCT02452944|"~     Transurethral resection of bladder tumor (TURB) has been essential treatment for bladder~     tumours. Direct electrical stimulation of an obturator nerve during the TURB procedures can~     trigger an inadvertent adductor muscle spasm, which can cause a serious complication like~     bladder perforation.~      General anesthesia with muscle relaxants for TURB does not guarantee a prevention of the~     adductor muscle spasm. Spinal anesthesia with selective obturator nerve block (ONB) can be an~     alternative anesthesia for TURB, but adductor spasm can also be induced because of incomplete~     ONB. Recently, ultrasound guidance with nerve stimulator has been used to enhance the safety,~     efficacy and shortening the onset time of ONB.~      Some papers describe that comparable ONB can be done using ultrasound only without nerve~     stimulator, in which there is a principle that obturator nerve runs along a given pathway.~     Basically, obturator nerve is divided into two branches after exiting the obturator canal.~     The anterior branch is located in the fascial planes among adductor longus, adductor brevis~     and pectineus muscles, and the posterior branch is located between the adductor brevis and~     adductor magnus muscles at the inguinal area. But it has been known that there are many~     branching patterns of obturator nerve and high anatomic variability in the inguinal area in a~     cadaver study. And subdivisions of obturator nerve in the inguinal area have been described.~      Therefore, this study was conducted to investigate the success rate of ultrasound-guided~     obturator nerve block with interfascial injection approach group (US-IFI; experimental group)~     was comparable to ultrasound-guided obturator nerve block with nerve stimulating approach~     group (US-NS; control group) in TURB under spinal anesthesia. And we also evaluated adductor~     muscle twitching patterns at the inguinal region when the ONB was performed.~   "
85113|NCT02452931|"~     This study determines the effectiveness of leuprolide acetate 45 mg for injectable suspension~     for treatment of children with Central Precocious Puberty.~   "
85114|NCT02452918|"~     This is a Phase 4, multicenter, open-label safety study of a single 1200 mg intravenous (IV)~     infusion of oritavancin in adult subjects on chronic warfarin with acute bacterial skin and~     skin structure infection (ABSSSI) suspected or proven to be caused by Gram-positive~     pathogens.~      An additional group of patients with ABSSSI, who are not on concomitant warfarin therapy,~     will also be enrolled to obtain information regarding the potential for antibody production~     following a single dose of oritavancin administration in patients.~   "
85115|NCT02452905|"~     Bronchiolitis is an extremely common cause of respiratory illness in infants caused by viral~     infection.This study evaluates whether treatment with nitazoxanide (NTZ) reduces the duration~     and severity of respiratory symptoms caused by bronchiolitis. Half of the participants will~     receive NTZ while the other half will receive a placebo.~   "
85116|NCT02452892|"~     The purpose of this study is to compare the relative effectiveness of 20 and 60 minutes of~     Low-Field Magnetic Stimulation in relieving symptoms in patients with major depression who~     are treatment resistant.~   "
85117|NCT02452879|"~     The purpose of this study is to determine whether electroacupuncture is effective in the~     treatment of overactive bladder.~   "
85118|NCT02452866|"~     This is a Phase 3, multi-center, prospective, open-label study to evaluate the safety of~     SYM-1219 granules containing 2 grams of secnidazole in women and postmenarchal adolescent~     girls with bacterial vaginosis.~   "
85119|NCT02452853|"~     Hepatocellular carcinoma (HCC) is the sixth most common cancer and the third most frequent~     cause of cancer death worldwide. Hepatic resection (HR) is the conventional ''curative''~     treatment for HCC. In both the European and the United States Proposed Guidelines for HCC, HR~     is recommended only for patients with preserved liver function and with early stage HCC.~     Unfortunately, because of tumor multifocality, portal vein invasion, and underlying advanced~     cirrhosis, only 10% to 30% of HCCs are amenable to such a ''curative'' treatment at the time~     of diagnosis. Transarterialchemoembolization (TACE) has become the most popular palliative~     treatment for patients with unresectable HCC, and it is no longer considered as a~     contraindication to HCC with portal vein tumor thrombus (PVTT). Unfortunately, the long-term~     outcomes are generally poor for HCC treated with TACE, especially for HCC with PVTT. To~     improve on the results of treatment of HCC with PVTT, attempts have been made to perform HR~     for these patients. HCC with PVTT remains a contraindication to liver transplantation because~     of the high rate of tumor recurrence, and because of the severe shortage of donor organs. HR~     remains the only therapeutic option that may still offer a chance of cure. With advances in~     surgical techniques, it has become feasible to remove all gross tumors, including PVTT, which~     has extended to the main portal vein, safely by surgery. More HCC with PVTT, which previously~     were considered as unresectable, have become resectable.Recent studies have even shown~     favorable long-term survival outcomes of HR in well-selected cases of HCC with PVTT. However,~     the recurrence rate after HR for PVTT is still high and the prognosis for patients with HCC~     with PVTT is very poor. Systemic chemotherapy is considered to be one of the main treatments~     for malignant tumors. HCC is known to be highly refractory to conventional systemic~     chemotherapy because of its heterogeneity and multiple etiologies. Before the advent of the~     molecular-targeted agent sorafenib, which has subsequently become the standard of care, no~     standard systemic drug or treatment regimen had shown an obvious survival benefit in HCC.~     Nowadays, there is no systemic chemotherapy regimen had been definitively recommended as the~     standard for treating HCC. Clinical activity of several regimens containing oxaliplatin (OXA)~     in advanced HCC had been demonstrated in phase II studies. In a phase II study of the FOLFOX4~     (infusional fluorouracil [FU], leucovorin[LV], and OXA) regimen in Chinese patients with HCC,~     median overall survival (OS) was 12.4 months, mean time to progression was 2.0 months, and~     the response rate (RR) was 18.2%. The safety profile was acceptable. Recently, the results of~     a phase Ⅲ randomize study showed that FOLFOX4 served as palliative chemotherapy can induce~     higher overall survival, progression-free survival and response rate comparing to doxorubicin~     in patients with advanced hepatocellular carcinoma from Asia. The safety data was also~     acceptable.So the investigators' hypothesis is that post-surgery FOLFOX4 can reduce high~     recurrence rate after HR for HCC with PVTT. The aim of this open-label, single prospective~     study is to evaluate the efficacy and safety of HR combined with FOLFOX4 systemic~     chemotherapy for patients with HCC with PVTT.~   "
85120|NCT02452840|"~     The purpose of this prospective observational study is to assess the potential clinical~     effects of adjunctive verteporfin photodynamic therapy (PDT) for persistent disease activity~     among patients with neovascular age-related macular degeneration (NV AMD). No specific~     interventions will occur as part of the study; participating subjects undergoing PDT as part~     of standard-of-care will be asked to consent to prospective collection of data from their~     medical records for up to five years from the date of consent, including results from~     ophthalmologic exams, imaging, and treatments. The primary study outcome will be the~     percentage of subjects with resolution of persistent disease activity at six months post-PDT~     treatment. Aside from a small risk of loss of confidentiality, risks associated with this~     study are no greater than those related to standard of care.~   "
85121|NCT02452827|"~     In recent years, an anatomical connection of suboccipital muscle fibers to the dura has been~     found in pathological studies. The physiologic function of these fibers is still unknown.~     Using Magnetic Resonance Tomography (MRI), this study will investigate whether these fibers~     undergo changes in patients suffering from primary chronic neck pain. In addition, the~     biomechanical parameters of neck movements in these patients will be correlated with the~     imaging findings.~   "
85122|NCT02452814|"~     Long Term Observational Extension Study Designed to Monitor Long-Term Efficacy and Safety of~     Miravirsen Sodium in Combination with Telaprevir and Ribavirin in Subjects with Chronic~     Hepatitis C Virus Genotype 1 Infection~   "
85123|NCT02452801|"~     This study will evaluate the effect of various degrees of hepatic function on the~     pharmacokinetics and safety of ALKS 5461.~   "
85124|NCT02452788|"~     The purpose of this study is to evaluate the effectiveness of pharmaceutical care, compared~     to usual care, in improving medication adherence behaviour of ambulatory hemodialysis~     patients.~   "
85125|NCT02452775|"~     This is a randomized pilot trial to test the addition of 2 investigational agents, Montanide~     and poly-ICLC (a TLR3 agonist) to a backbone of autologous oxidized tumor cell lysate vaccine~     (OC-L) administered with GMCSF in subjects with primary epithelial ovarian, fallopian tube,~     or primary peritoneal cancer.~   "
85147|NCT02452489|"~     With Diabetic gastroparesis as the research object, by the method of multi-center RCT and~     single cavity and different acupuncture acupoints compatibility treatment of diabetic~     gastroparesis, the inspection of gastric emptying, gastric dynamic inspection, such as~     validity checking means, for single cavity with different acupoints compatibility evaluate~     clinical efficacy of treatment of diabetic gastroparesis.~   "
85126|NCT02452762|"~     Documented roles for vitamin D in calcium homeostasis, cardiovascular and respiratory health,~     inflammation, innate immunity, and neuromuscular function have led to the hypothesis that~     deficiency might represent a modifiable risk factor for outcomes in critical illness. In~     recent years, dozens of adult studies have reported both high deficiency rates, and~     associations between lower vitamin D levels and organ dysfunction, health resource~     utilization, and mortality in the intensive care unit (ICU). More recently, similar~     observations have been made in critically ill pediatric populations. The cumulative body of~     basic science and clinical literature demonstrates that deficiency is common in critical~     illness and rapid normalization of vitamin D status could improve clinical outcomes and/or~     reduce health care costs. However, before conducting a phase III trial to determine whether~     restoration of vitamin D status improves outcomes in the PICU, the appropriate dosing regimen~     must be identified. Consequently, the investigators propose a phase II, double blind~     randomized controlled trial to determine a loading therapy dosing regimen that can safely and~     rapidly normalize vitamin D status in critically ill children.~   "
85127|NCT02452749|"~     This single-arm, open-label study will assess the safety and tolerability of one daily tablet~     of a commercially available cardiovascular health dietary supplement by questionnaire and~     blood markers in adults with borderline to mild hypertension over a 6 month period. Although~     the cardiovascular health dietary supplement being investigated has been on the market for~     over 20 years, prospective safety data and blood markers of end organ function have not~     previously been reported.~   "
85128|NCT02452736|"~     The purpose of this study is to conduct a prospective, multi-center, single arm,~     non-randomized evaluation of acute outcomes in Chinese subjects, including those eligible for~     percutaneous transluminal coronary angioplasty (PTCA) with a reference vessel diameter of~     2.25 mm to 4.0 mm, with the Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent~     System.~   "
85129|NCT02452723|"~     This study will evaluate the safety of an investigational cell transplantation therapy,~     ISC-hpNSC, in patients with Parkinson's disease. All patients will receive the therapy, which~     consists of human neural stem cells. Three dose levels will be examined in the study.~   "
85130|NCT02452710|"~     This research study is evaluating the usefulness of a placebo (a tablet with no active~     ingredients) on fatigue in cancer survivors.~   "
85131|NCT02452697|"~     This is a randomized, parallel phase II study to evaluate the rates of progression-free~     survival and unacceptable toxicity in patients receiving NK cell-enriched donor lymphocyte~     infusions (DLIs) when administered alone or administered with the TLR9 agonist, DUK-CPG-001,~     from a 7-8/8 HLA-matched related or unrelated donor (Cohort A) or 4-6/8 HLA-matched related~     donor (Cohort B) following reduced intensity or non-ablative allogeneic stem cell~     transplantation. Randomization will be stratified for disease types (myeloid versus lymphoid~     malignancies). Primary endpoints are analyzed separately in Cohort A and B.~      Cohort A: 7-8/8 HLA-matched related or unrelated donor (NK cell enriched-DLI only arm or~     NK cell enriched-DLI + DUK-CPG-001 arm)~      Cohort B: 4-6/8 HLA-matched related donor (NK cell enriched-DLI only arm or NK cell~     enriched-DLI + DUK-CPG-001 arm)~   "
85132|NCT02452684|"~     To investigate the safety and efficacy of administration of eszopiclone for 4 weeks in~     insomnia patients.~   "
85133|NCT02452671|"~     This is a multi-center, non-randomized, observational study to further evaluate the~     effectiveness and safety of the Proxifuse Hammer Toe Device when utilized for bone fixation.~     Approximately 4 US sites will participate. The primary endpoint will evaluate the 6 month~     post surgery change from baseline in the PROMIS Pain Interference computerized adaptive test~     (CAT) score.~   "
85134|NCT02452658|"~     Participants will be exposed to a hypothetical fast food menu, asked to place a hypothetical~     lunch order, and will then be exposed to a second menu with several changes made to the menu.~     Participants will be asked to identify as many changes as possible on this second menu, and~     then complete a survey about their eating tendencies and demographics.~   "
85135|NCT02452645|"~     Drs. Patricia Risica (Brown University) and Kim Gans (University of Connecticut) are Dual~     Principal Investigators for this project. The research team will first conduct formative~     research using focus groups and key-informant interviews of Family Child Care Home (FCCH)~     providers. This formative work will inform our adaptation of components of previous~     evidence-based interventions to create a new innovative intervention in both English and~     Spanish to improve food and PA environments of Family Child Care Homes (FCCH). The~     intervention will integrate: a) support from peer counselors with child care experience who~     will serve as team leaders for groups of FCCPs; b) tailored print and video materials; and c)~     a set of portable active toys. A cluster-randomized trial with 132 FCCH will evaluate the~     effectiveness of the intervention with a Steering Committee and Community Advisory Board~     guiding all aspects. The Specific Aims of the study are to: 1) Conduct formative research to~     inform the development and adaptation of the FCCH intervention. 2) Conduct a~     cluster-randomized trial of the intervention's efficacy with 66 FCCH providers and a control~     intervention with 66 demographically-matched FCCH providers to evaluate its impact on: a)~     Children's overall dietary quality at FCCHs; b) Children's PA and sedentary behaviors at~     FCCHs; and c) the physical and social food and PA environments of FCCHs. Evaluation methods~     will include survey data collection of the FCCH Providers; observation of children's' dietary~     intake and physical activity in FCCHs; recruitment of children within the FCCH for physical~     and survey measurement with permission from their parents.~   "
85136|NCT02452632|"~     The purpose of this study is to compare the efficacy and safety of ASP1941 50mg once daily in~     combination with metformin and sitagliptin against placebo in combination with metformin and~     sitagliptin over a 24 week treatment period in subjects with type 2 diabetes mellitus with~     inadequate glycemic control on metformin and sitagliptin.~   "
85137|NCT02452619|"~     In our institute there is ongoing treatment of brain injury patients with Hyperbaric oxygen~     therapy. These patients undergo neuro-cognitive function tests in addition to brain imaging~     studies before and after treatment.~      The aim of this study was to evaluate the perfusion and microstructure changes seen in MRI in~     addition to the cognitive tests before and after the treatment.~   "
85138|NCT02452606|"~     The purpose of this study is to investigate the genetic variants of clock and narcolepsy~     genes that determine the therapeutic effects of Stalevo® on the quality of sleep in patients~     with Parkinson's Disease.~   "
85139|NCT02452593|"~     Urinary incontinence is defined according to the International Continence Society as any~     involuntary loss of urine, which may bring several negative consequences on women's lives,~     and among incontinent women, about 50% have urinary incontinence, 30% mixed and 20%~     emergency.~      The overactive bladder present in urge incontinence and mixed cause significant impacts on~     people's lives and has a prevalence of 16.5% in the US population.~      Behavioral therapies, exercises the pelvic muscles and drugs are the main forms of treatment.~     Drug therapy using drugs which are not specific for the bladder and are associated with many~     unwanted systemic side effects.~      The results obtained by researchers in several countries using conservative techniques in the~     treatment of patients with urinary incontinence are encouraging and this study aims to~     evaluate carefully and systematically the effectiveness of tibial stimulation technique.~      Importantly, also, that conservative techniques have lower cost than the surgical treatment~     and have virtually no side effects as most of the drugs used in the pharmacological treatment~     of female urinary incontinence.~   "
85140|NCT02452580|"~     This study evaluates possible effects of two different NICU designs; by comparing traditional~     and Family Centered Care in terms of infant nutrition, health and growth, and coping by~     family.~   "
85141|NCT02452567|"~     Obesity is associated with a constellation of cardiometabolic abnormalities (including~     insulin resistance, elevated blood pressure and dyslipidemia) that are risk factors for~     diabetes and cardiovascular disease. Weight loss can improve all of the cardiometabolic~     abnormalities associated with obesity. Up to ~25% of lean people (Body Mass Index[BMI]~     18.5-24.9kg/m2) have many of the cardiometabolic abnormalities associated with obesity and~     are referred to as metabolically abnormal lean (MAL) people. However, the MAL phenotype is~     not well characterized and it is unclear whether weight loss has beneficial metabolic effects~     in already lean people. Accordingly, the goal of this study is to: 1) carefully phenotype MAL~     people and 2) evaluate the effect of moderate (8-10%) diet-induced weight loss in MAL people.~     This will be investigated in 15 MAL (defined as intrahepatic triglyceride (IHTG) content~     ≥5.6% and glycated hemoglobin ≥5.7%, or fasting plasma glucose concentration ≥100 mg/dl, or~     2-hr oral glucose tolerance test (OGTT) plasma glucose concentration ≥140 mg/dl) men and~     women. Only lean people who have a BMI>/= 21.0 but <25.0kg/m2 will be asked to lose weight to~     avoid the risk that participants become underweight (BMI <18.5kg/m2) during weight loss~     therapy..~   "
85142|NCT02452554|"~     This phase II trial studies how well lorvotuzumab mertansine works in treating younger~     patients with Wilms tumor, rhabdomyosarcoma, neuroblastoma, pleuropulmonary blastoma,~     malignant peripheral nerve sheath tumor (MPNST), or synovial sarcoma that has returned or~     that does not respond to treatment. Antibody-drug conjugates, such as lorvotuzumab~     mertansine, are created by attaching an antibody (protein used by the body's immune system to~     fight foreign or diseased cells) to an anti-cancer drug. The antibody is used to recognize~     tumor cells so the anti-cancer drug can kill them.~   "
85143|NCT02452541|"~     Severe traumatic brain injury (TBI) is the leading cause of death and disability among people~     under 45 years of age and a major public health problem. Although management of severe TBI~     patients has gradually improved with the establishment of intensive care units (ICU) and the~     development of practice guidelines, mortality is still high - ranging from 30 to 50% - with~     30% of survivors suffering from severe neurological sequelae such as neurovegetative states.~     Families and medical teams are frequently called upon to determine reasonable and appropriate~     goals of care for brain injured patients. They may have to consider high intensity of care,~     but also the withdrawal of life-sustaining therapies in accordance with patient wishes.~     Physicians involved in the care of severe traumatic brain injury have expressed serious~     concerns about hasty decisions made in the absence of appropriate evidence of unfavourable~     prognosis. The purpose of the TBI-Prognosis study is to develop a prognostic model by using a~     multimodal approach of different prognostic indicators and their evolution over time in the~     acute phase of care. The results of this study will provide better objective information that~     will facilitate the shared-decision making-process with families and relatives.~   "
85144|NCT02452528|"~     Participants with chronic HBV infection will receive multiple doses of ARC-520 in combination~     with entecavir or tenofovir and be evaluated for safety and efficacy.~   "
85145|NCT02452515|"~     The purpose of the trial is the analysis of safety and tolerability of the chymase inhibitor~     BAY1142524 in comparison to placebo using a 2 weeks treatment period in clinically stable~     patients with left-ventricular dysfunction after myocardial infarction. BAY1142524 or placebo~     will be given on top of evidence-based standard of care for left-ventricular dysfunction~     after myocardial infarction. Primary objectives are the analysis of safety and tolerability~     as evidenced by the incidence and severity of adverse events. BAY1142524 will be administered~     in a parallel group design using four doses (5, 10, 25 mg twice daily, and 50 mg once daily).~     Each dose group consists of 9 patients treated with verum and 3 patients treated with~     placebo.~   "
85146|NCT02452502|"~     Emerging studies have shown that statin treatment has pleiotropic non-cholesterol-dependent~     effects in the setting of ischemic stroke.~      Recombinant tissue plasminogen activator (rt-PA) is the only proven effective pharmaceutical~     treatment for hyper-acute management of ischemic stroke, in spite of the deleterious~     side-effects such as hemorrhagic transformation and reperfusion injury. These harmful impacts~     can be counteracted with proper neuro-protective therapy. In fact, the simultaneous use of an~     effective neuro-protective agent was proved to reduce the comorbid vascular injury of rt-PA.~     In experimental research, high dose of atorvastatin combined with rt-PA can significantly~     reduce infarct volume and improve the neurologic deficits. Previous studies showed that fewer~     than 40% ischemic stroke patients established early reperfusion after intravenous~     thrombolysis, while high dose of atorvastatin was revealed to favor the maintenance of~     cerebral vascular patency and integrity, most likely by reducing thrombosis secondary to~     rt-PA administration. Moreover, it was suggested that statin can sufficiently improve the~     restoration and remodeling of neurovascular unit in cerebral cortex.~      Investigators thus design this study to prospectively investigate whether high dose of~     atorvastatin prescribed within 24 hours after IV-thrombolysis will have a synergic effect to~     improve neurological outcome in acute ischemic stroke patients. Moreover, investigators~     deemed it necessary to non-invasively monitor neuronal and vascular morphological changes in~     brain as an indication of functional improvement. In the investigation centers, investigators~     have developed and implemented novel multimodality MR imaging which can dynamically monitor~     neurovascular remodeling. Therefore, it is worthwhile to evaluate these MRI measurements for~     early prediction of neurovascular reorganization with long term functional recovery in~     thrombolytic stroke patients administrated with high dose of atorvastatin.~      The primary target of this study is to prospectively investigate whether high dose of~     atorvastatin (80mg) administrated within 24 hours after IV-thrombolysis will have a synergic~     effect to improve neurological outcome in acute stroke patients, versus moderate dose.~   "
85176|NCT02452112|"~     This is a randomized, double-blind, placebo-controlled study designed to assess the efficacy~     and safety of 5% lidocaine patch, following placebo or active patch applications in placebo~     insensitive subjects.~   "
85148|NCT02452476|"~     A multicenter, double blind, randomized, single dose, active-controlled study to investigate~     the efficacy and safety of synthetic surfactant (CHF 5633) in comparison to porcine~     surfactant (Poractant alfa, Curosurf ®) in the treatment of preterm neonates with respiratory~     distress syndrome. Main objectives of this study are to investigate the short term efficacy~     profile of CHF 5633 vs. porcine surfactant (Poractant Alfa, Curosurf®) in terms of reduced~     oxygen requirement and ventilatory support and to evaluate the mid-term efficacy profile in~     terms of reduced incidence of bronchopulmonary dysplasia (BPD) and mortality/BPD rate at 36~     weeks post menstrual age (PMA), mortality rate at 28 days and 36 weeks PMA, RDS-associated~     mortality through 14 days of age and other major co-morbidities of prematurity.~      Inclusion criteria are: Written parental informed consent, inborn preterm neonates of either~     sex with a gestational age of 24+0 weeks up to 29+6 weeks, clinical course consistent with~     RDS, requirement of endotracheal surfactant administration within 24 hours from birth,~     fraction of inspired oxygen (FiO2) ≥0.30 for babies 24+0 to 26+6 weeks and FiO2 ≥0.35 for~     babies 27+0 to 29+6 weeks to maintain SpO2 between 88-95%.~   "
85149|NCT02452463|"~     This randomized phase II trial studies the side effects and how well nintedanib works~     compared to a placebo in treating against radiation-induced pneumonitis (inflammation of the~     lungs) in patients with non-small cell lung cancer that cannot be removed by surgery and are~     undergoing chemoradiation therapy. Nintedanib may help shrink or slow the growth of~     radiation-induced pneumonitis by blocking some of the enzymes needed for cells to grow and~     may prevent the growth of new blood vessels. It may also help reduce the recurrence of~     non-small cell lung cancer.~   "
85150|NCT02452450|"~     The purpose of this study was to determine rates of absorption of Ibuprofen and Paracetamol~     formulations.~   "
85151|NCT02452437|"~     To measure oxycodone's intradialytic mass transfer rate coefficient and oxycodone's removal~     rate using an ODE/PDE hemodialysis model. To implement a rational clinical strategy for~     estimating a patient's post-hemodialysis oxycodone restoration dose using results from an~     ODE/PDE model of hemodialysis.~   "
85152|NCT02452424|"~     The goal of this clinical research study is to learn how PLX3397 and pembrolizumab work~     together to affect cancer cells.~      PLX3397 is designed to target the receptor for CSF1 (CSF1R). Pembrolizumab is designed to~     block the interaction between the receptor PD-1 and molecules that bind PD-1. In this study,~     PLX3397 and pembrolizumab are being given together in order to study their combined effects~     on patients' immune responses to their tumors. Tumor-specific immune responses have been~     shown to kill cancer cells and/or to stop tumors from growing.~      Part 1 of the study (dose-escalation phase) will establish the safest dose of PLX3397 to be~     given in combination with pembrolizumab. Part 2 of the study (expansion phase) will include~     an evaluation of efficacy of this combination in the following tumor types:~        -  Advanced melanoma: prior anti-PD-1/PD-L1 therapy but never responded~        -  Advanced melanoma: prior anti-PD-1/PD-L1 therapy and responded but later progressed as~          defined by irRECIST while on therapy~        -  Non-small cell lung cancer~        -  Ovarian cancer~        -  Gastrointestinal Stromal Tumor (GIST)~        -  Squamous cell cancer of the head and neck~   "
85153|NCT02452411|"~     The purpose of this study is to determine the differential efficacy of two ways of applying~     homework assignments in the treatment of Adjustment Disorders: 1) using an Internet-based~     emotional regulation therapy system (TEO) and 2) in the traditional way (using reading and~     audio materials).~      The principal hypothesis is that both treatment conditions (TEO and Traditional) will show a~     similar efficacy. All participants will improve significantly on all outcome measures,~     regardless the type of homework assigned (TEO or Traditional) with no differences between~     them.~   "
85154|NCT02452398|"~     This is a Multi-center, blinded, baseline-controlled, prospective study to evaluate permanent~     hair reduction and removal for skin types V and VI using IPL.~   "
85155|NCT02452385|"~     This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability, and~     Pharmacokinetics of CM082 tablets in Chinese Patients With wet-AMD.~   "
85156|NCT02452372|"~     The purpose of this study is to evaluate the safety and tolerability of givosiran (ALN-AS1)~     in AIP patients as well as to characterize pharmacokinetics (PK) and pharmacodynamics (PD) of~     ALN-AS1 in AIP patients.~   "
85157|NCT02452359|"~     This trial is intended to evaluate the effect of IPL treatment on the Striae Distensae. The~     study hypothesis is that the SR580 applicator will improve the appearance of Striae Distensae~     by at least 1 point on the Global Aesthetic Improvement ScaleI (GAIS) at 3 months follow-up~     compared to baseline in at least 50% of the study population.~   "
85158|NCT02452346|"~     Study WCMC IST-CTI-MDS evaluates the safety and tolerability of tosedostat in adult patients~     with pathologically confirmed MDS (< 20% blasts in bone marrow, peripheral blood, or both) by~     World Health Organization (WHO) classification after failure of hypomethylating agent-based~     therapy.~   "
85159|NCT02452333|"~     Many studies focusing on breast conserving surgery have affirmed the cosmetic effectiveness~     and oncologic success of oncoplastic methods and even modified variants of these methods~     reinforced with videoscopic applications. However, primary lumpectomy subjects in these~     studies are mainly patients who have already received the diagnosis of malignancy before the~     surgery. There is not much comprehensive work reported for patients without the diagnosis of~     malignancy. In this regard, the investigators believe the intent of the innovative~     oncoplastic intervention to the breast is underestimated in terms of providing diagnosis~     simultaneously constituting the basic component of surgical treatment. Thus, the purpose of~     this prospectively planned study is to provide and investigate the outcomes of an~     evidence-based oncoplastic approach algorithm for excisional breast biopsies.~   "
85160|NCT02452320|"~     The purpose of this study is to determine if the administration of acetaminophen given~     intravenously (through an IV) beginning during surgery and then for 3 additional doses during~     the first 24 hours post-operatively will reduce the length of time subjects undergoing~     elective sleeve gastrectomy spend in the hospital following this operation. Additional~     questions that may be answered include whether administration of the study medication leads~     to improvement in pain control, a reduction in post-operative nausea and vomiting, and an~     overall improvement in quality of recovery.~   "
85161|NCT02452307|"~     The study evaluates the prostate-specific antigen (PSA) response in HLA-A*02 positive~     patients with biochemical recurrence after radical prostatectomy treated with a~     prostate-specific peptide vaccine in combination with different immune-adjuvants.~   "
85162|NCT02452294|"~     The study will enrol adult female and male patients with BRAF wild-type melanoma and brain~     metastases who are not eligible for surgery or radiosurgery and failed prior therapy with~     ipilimumab, and patients with BRAF V600 mutation-positive melanoma and brain metastases who~     are not eligible for surgery or radiosurgery and who failed prior therapy with a BRAF~     inhibitor.~   "
85163|NCT02452281|"~     The purpose of this research study is to see if the combination of HSPPC-96 and ipilimumab is~     safe and effective in the treatment of advanced melanoma. HSPPC-96 is an investigational~     vaccine created from tissue from the patient's tumor. The vaccine is designed to capture the~     cancer's fingerprint. Injection of the vaccine may cause the patient's immune system to~     recognize and attack any cells with the specific cancer fingerprint. Ipilimumab is a drug~     approved by the FDA for the treatment of metastatic melanoma that boosts immune response.~   "
85164|NCT02452268|"~     Phase I/Ib multicenter clinical trial. Single agent dose escalation of NIZ985 followed by~     expansion. Second escalation of NIZ985 in combination with PDR001 followed by expansion~   "
85165|NCT02452255|"~     The proposed study will test the hypothesis that Propranolol, fenofibrate and fenofibrate~     plus propranolol have therapeutic, physiological, and metabolic effects that will improve~     clinical outcomes, and the long-term recovery, rehabilitation, and QOL in burned patients.~   "
85166|NCT02452242|"~     ABX464 is a first in class that showed efficacy as an anti-HIV therapy. The present study is~     intended to assess the safety, the tolerability, and pharmacokinetic parameters and to~     evaluate the effect on viral load of repeated oral administrations of ABX464 in patients~     infected by HIV, not previously treated for their HIV.~      Two types of design are intended in this protocol: dosing every 3 days or dosing every day.~     The goal is to determine the best dosing regimen to reduce viral load and minimize adverse~     events.~   "
85167|NCT02452229|"~     Herpes simplex virus, cytomegalovirus and varicella zoster virus infection are purported to~     play a pivotal role in morbidity and mortality in burns. Thus far, there is no existing~     systematic review (Level of Evidence III or higher) describing the unique role as well as~     concurrent infections of these viruses in burns. The aim of this review is to point out the~     clinical differences between these human herpes virus subtypes, to outline established~     therapy approaches, and to provide evidence for virus related morbidity and mortality in~     burns.~   "
85168|NCT02452216|"~     This pilot clinical trial study will assess the inflammatory response of brain tumors or~     other central nervous system conditions in pediatric and adult patients using~     ferumoxytol-enhanced MRI. Imaging features will be correlated with the number of inflammatory~     cells (macrophages) at histopathology. Determining the extent of inflammation associated with~     pathologies in the central nervous system may be helpful for diagnostic and prognostic~     purposes as well as monitoring treatment response of current and future immunotherapies.~   "
85169|NCT02452203|"~     The studies proposed in this protocol aim to explore the anxiolytic properties of floating as~     it relates to the central and autonomic nervous system.~   "
85170|NCT02452190|"~     The primary objective of this study is to determine the effect of reslizumab (110 mg)~     administered subcutaneously every 4 weeks on clinical asthma exacerbations in adults and~     adolescents with asthma and elevated blood eosinophils who are inadequately controlled on~     standard-of-care asthma therapy.~   "
85171|NCT02452177|"~     Patients who accept long-term parenteral nutrition tend to suffer from liver injury. The~     mechanism for this injury has two possible explanations. The first possible reason is~     intrinsic toxic effects of parenteral nutrition. The second is the basic pathological~     condition of intestinal failure which includes infection, bacterial translocation, etc.~     Cholestasis is the lethal presentation of this kind of liver disease. Farnesoid X receptor~     (FXR) is a member of ligand-activated nuclear receptor superfamily. FXR serves as a sensor~     for bile acids and promotes enterohepatic clearance of bile acids by controlling the~     expression of genes involved in their transport and metabolism. Considering the activation of~     vitamin D receptor (VDR) by vitamin D can induce FXR-related genes in the liver.The~     hypothesis of this study is that vitamin D plays a key role in the prevention and reversion~     of the liver via VDR and/or FXR signaling pathway. Using a mouse cholestasis model based on~     short bowel syndrome and parenteral nutrition, the researchers will investigate the dynamic~     change of plasma vitamin D level. Afterward, intravenous supplement of vitamin D was added to~     this model to demonstrate vitamin D can ameliorate cholestasis. An in vitro system was~     developed to investigate the importance of FXR signaling pathway in this effect.~   "
85172|NCT02452164|"~     This is a one-center clinical study carried out in Turku, Finland. The study patients will be~     randomly allocated to one of the two parallel study groups (teaching group and control~     group). The hypothesis is that the diagnostic quality of tympanic membrane imagines is better~     when parents have been taught to conduct middle ear examination with a cellphone otoscope~     (CellScopeOTO) as compared to no teaching. Furthermore, this study aims at evaluating the~     diagnostic feasibility of cellphone otoscopy.~   "
85173|NCT02452151|"~     The objective of this study is to compare the efficacy of Infliximab-Biosimilar to~     Infliximab-Innovator and to demonstrate its noninferiority, in patients with ulcerative~     colitis or Crohn's disease in remission under treatment with infliximab up to 3 months.~   "
85174|NCT02452138|"~     Endotoxin is the major mediator of sepsis resulted from systemic inflammatory response~     syndrome induced by gram-negative bacteria infection. The endotoxin related inflammatory~     response and hypercoagulation can result in microcirculatory dysfunction. When~     microcirculatory dysfunction is severe, it can induce multiple organ dysfunction syndrome and~     death. This is a prospective observational study, and it will not influence the sepsis~     treatment decision of the medical care team. The critically ill severe sepsis patients will~     be enrolled only if they meet all inclusion criteria, do not meet any exclusion criteria and~     sign the consent form after explanation of the aim and process of the trial by the primary~     investigator or research personnel. After enrollment, the patient will receive serum assay of~     endotoxin activity (EAA) and endocan level. The patient will also receive examination of~     sublingual microcirculation by using the incident dark field video microscope. After 24~     hours, the patient will receive assay of endocan level and examination of sublingual~     microcirculation. This study will record the vital signs, laboratory data, dose of~     vasopressors and inotropic agents, and severity of organ dysfunction. After 28 days, this~     study will check the survival, stay of intensive care, stay of hospital, ventilator day, and~     the results of culture of pathogens. The patients will be assign to the following three~     groups by the EAA level: low EAA group (< 0.40 EAA units); intermediate EAA group (0.40-0.59~     EAA units); and high EAA group (≧ 0.60 EAA units). This grouping will be used for statistical~     analysis and comparison. The primary goal of this study is to investigate the difference of~     the prevalence of gram-negative bacteria infection, pathogen, infection source,~     microcirculation, the severity of disease, and the prognosis among these three groups.~   "
85175|NCT02452125|"~     The objective of this experiment is:~      To determine if nicotine chewing gum will improve acute episodes of orthostatic hypotension~     in PD subjects.~   "
85178|NCT02452086|"~     The purpose of this study is to examine the changes of factors including Vascular Endothelial~     Growth Factor(VEGF), VEGFReceptor-2, Nitric Oxide and hypoxia-inducible factor-1α (HIF-1α),~     measurements of oxygen saturation in peripheral blood and wound surface area and~     ankle-brachial index (ABI) in ischemic diabetic foot ulcers after Low Level Laser~     Therapy(LLLT).~   "
85179|NCT02452073|"~     Radiation enteritis (RE) is by simple definition an inflammatory process occurring at the~     level of the intestines as a response to abdominal or pelvic radiation energy exposure. Due~     to the dosage of radiation, sensitivity of organs to radiation, and some patient~     characteristics, RE can present as either an acute or chronic syndrome. Clinical~     manifestations differ but may include abdominal pain, malabsorption, diarrhea, cachexia,~     intestinal bleeding, obstruction, and even perforation, which compromise quality of life. For~     many years, radiotherapy of the abdominal or pelvic region is commonly used for a significant~     percentage of patients with rectosigmoid and genitourinary system tumors. Different~     techniques have been developed to prevent the occurrence of radiation induced injury.~     However, the incidence of CRE is expected to continue to rise during the coming years. What's~     more, abdominal or pelvic radiotherapy can also lead to other side effects in addition to RE,~     such as skin desquamation, local soft tissue injury, and so on. Till now, lots of attention~     is only paid to local complications, there is little report on systemic damage of abdominal~     or pelvic radiotherapy.~      Low triiodothyronine syndrome (LT3S), a condition characterized by low circulating~     triiodothyronine (T3) levels, normal thyroxine (T4), free thyroxine (FT4) and~     thyroid-stimulating hormone (TSH) levels in the absence of an intrinsic thyroid disease, is~     variously known as the nonthyroidal illness syndrome (NTIS). This condition is frequently~     detected in critical illness. Reichlin et al. first noticed that some aspects of thyroid~     hormone metabolism might change during many chronic illnesses as early as 1973. Data has~     shown that about 35-70% of acute and chronic critical conditions were associated with a~     significant abnormal thyroid hormone metabolism, of which LT3S was the most common type.~     Furthermore, these changes have been shown to be associated with disease severity and have~     been connected with poor short-term prognosis.~      To date, there are lots of literatures include detailed reports on the relationship between~     LT3S and chronic illnesses such as rheumatoid arthritis, systemic lupus erythematosus,~     sepsis, and so on. However, no systematic analysis of LT3S in patients with CRE has been~     undertaken. As such, the present study aimed to investigate the frequency of LT3S in CRE~     patients.~   "
85180|NCT02452060|"~     This is a randomized, double-blind, placebo-controlled, two-arm parallel, single-center~     study. One hundred subjects (50 in each arm) will be enrolled. Subjects, between the ages 18~     and 65, undergoing laparoscopic gastric bypass or sleeve gastrectomy will be recruited and~     consented during the preadmission visit prior to surgery.~   "
85181|NCT02452047|"~     The study will evaluate the efficacy and safety of imipenem+cilastatin/relebactam (MK-7655A)~     versus colistimethate sodium + imipenem+cilastatin in the treatment of imipenem-resistant~     bacterial infections. Infections evaluated in the study will be hospital-acquired bacterial~     pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), complicated~     intra-abdominal infection (cIAI), and complicated urinary tract infection (cUTI).~   "
85182|NCT02452034|"~     This study aims to evaluate the pharmacokinetics of posaconazole (POS) administered~     intravenously (IV) or orally to immunocompromised pediatric participants.~   "
85183|NCT02452021|"~     This is a prospective observational study designed to observe the toxicity and efficacy of~     PBS proton RT for patients with esophageal cancer undergoing trimodality therapy. The~     investigators hypothesize that PBS proton RT will be associated with a favorable adverse~     event profile and quality of life, with similar disease control outcomes, relative to~     historical comparisons of patients treated with photon RT.~   "
85184|NCT02452008|"~     The primary objective of this study is to compare the progression free survival (PFS) of~     patients with metastatic castration-resistant prostate cancer treated with enzalutamide in~     combination with LY2157299 (Arm 1) versus enzalutamide alone (Arm 2).~   "
85185|NCT02451995|"~     Tachycardia's (fast heart rhythms) can lead to troublesome palpitations, dizziness, blackouts~     and breathlessness. They are caused either by a cluster of abnormal cells within the heart,~     or an electrical short circuit which rotates rapidly around the heart. Sometimes these can be~     controlled with tablets, though owing to side effects many patients want something else. Many~     tachycardia's can be cured by a procedure known as an ablation. In essence, either the~     focus of abnormal cells or the narrowest point of the short circuit causing the abnormal~     heart rhythm (the source) is electrically destroyed (burnt) resulting in restoration of the~     normal heart beat.~      One form of tachycardia is known is Atrial Tachycardia (AT). These arise from the top two~     chambers of the heart (the atrium). Interestingly, this problem is frequently seen in~     patients who have previously undergone an ablation or surgical procedure for a condition~     called Atrial Fibrillation. In others the reason for its occurrence is unknown. Current~     strategies to find the source during an ablation procedure are technically challenging~     resulting in long procedure times. Sometimes the wrong source is found resulting in ablation~     at the incorrect site.~      Ripple Mapping (RM) is a novel system that Investigators at Imperial College are looking to~     study. RM displays electrical information within the heart as a series of bars coming out of~     the chamber, with each bar representing signals travelling down the heart. By seeing the~     pattern of electrical information, they believe it will show the pattern of the tachycardia~     better than conventional techniques. In a previous study that they conducted, RM found the~     source of the tachycardia in 80% of the maps, compared to only 50% with the current system.~     Investigators at Imperial College have identified why they did not get 100% and they believe~     that, in future, RM will find the source of the tachycardia first time, and every time.~   "
85186|NCT02451982|"~     This study will be looking at whether CY/GVAX with nivolumab is more effective than CY/GVAX~     alone in altering the pancreatic tumor microenvironment (IL17 expression) to aid in the~     anti-tumor response.~   "
85187|NCT02451969|"~     The purpose of this study is to evaluate the immunogenicity and safety of an investigational~     23-valent pneumococcal polysaccharide vaccine (PPV) in healthy children, adults and elderly.~     The control vaccine is a commercialized 23-valent PPV.~   "
85188|NCT02451956|"~     This study is a single arm, single center phase II study of AZD5363 in combination with~     paclitaxel in patients with advanced gastric adenocarcinoma harboring PIK3CA mutation or~     amplification as a second line chemotherapy.~      Patients will receive AZD 5363 plus weekly paclitaxel combination regimen. A arm is composed~     of 25 patients.~      Tumour evaluation using RECIST 1.1 will be conducted at screening (within 28 days prior to~     first dose) and every 8 weeks relative to the date of enrollment, up to week 40, then every~     16 weeks until objective disease progression (within a window of +/- 7 days of the scheduled~     date).~      Study treatment will be continued until objective disease progression.~   "
85189|NCT02451943|"~     The main purpose of this study is to evaluate the efficacy of the combination of doxorubicin~     plus the study drug known as olaratumab versus doxorubicin plus placebo in participants with~     advanced or metastatic soft tissue sarcoma.~   "
85190|NCT02451930|"~     The main purpose of this study is to evaluate the safety and efficacy of the combination of~     necitumumab with pembrolizumab in participants with stage IV non-small cell lung cancer~     (NSCLC).~   "
85218|NCT02451566|"~     The primary objectives of the LIFE Study are to demonstrate the clinical cost and benefits~     associated with using the Ovation Prime Abdominal Stent Graft System under the least invasive~     conditions defined in the Fast-Track EVAR protocol. The key elements of the Fast-Track EVAR~     protocol include: appropriate patient selection, bilateral percutaneous access, no general~     anesthesia, no ICU admission post procedure, and next day discharge.~   "
85191|NCT02451917|"~     Chronic kidney disease (CKD) is one of the most common microvascular complications of~     diabetes mellitus, and it is the leading cause of end stage renal disease on developed~     countries. The CKD diagnosis and its progression require re-evaluation of hypoglycemic~     therapy and constant dosing adjustments, in order to optimize glycemic control and minimize~     its side effects. Long acting insulin analogs and its pharmacokinetics have not been studied~     through different stages of kidney disease and there is no consensus defining the appropriate~     dosing adjustment based on the glomerular filtration rate (GFR). This research project will~     compare the glycemic response to intensive insulin treatment with NPH insulin and basal~     insulin analog (insulin glargine) in type 2 diabetes (DM 2) patients with CKD stages 3 and 4.~     Patients and methods - Inclusion Criteria: DM 2 patients with CKD secondary to diabetic~     nephropathy and GFR of 15-59 ml/min/1.73m². Exclusion Criteria: Patients with systemic~     neoplasia, HIV, CKD or nephropathy from other etiologies, severe psychiatric disorders and~     pregnant women. Study design: This study consists of a randomized, cross-over, open-label~     controlled clinical trial. Patients will be randomly divided into two groups: GROUP 1 -~     insulin analog glargine once a day and GROUP 2 - NPH human insulin, three applications per~     day, both group will be treated with insulin lispro at mealtime. The laboratory tests will be~     performed at baseline and 12, 24, 36 and 48 weeks after the study start. During routine~     medical appointments will be analyzed self- monitoring of capillary blood glucose (SMBG) and~     the hypoglycemia score. After 24 weeks the basal insulin will be changed, i.e. patients using~     NPH insulin will receive insulin glargine and patients on insulin glargine will be changed to~     NPH insulin. A CGMS will be carried out at 24 and 48 weeks. Methodology: The metabolic~     profile will be evaluated throughout SMBG; biochemical, hormonal and hematological~     measurements; hypoglycemia score and CGMS. Statistical analysis will be performed using~     comparative descriptive analyzes, such as chi-square distribution, t-test and non-parametric~     tests. Analyze of data CGMS will include the area under the curve and the related statistic.~     Finally, logistic regression models will be adopted to evaluate the effect of the treatment~     on the several variables in question.~   "
85192|NCT02451904|"~     -  The aim is to describe disease mechanisms of severe and cerebral malaria and identify~          new targets for adjunctive therapies.~        -  Despite treatment between 10-30% of patients with severe malaria die.~        -  Metabolic acidosis and cerebral malaria are major complications associated with~          mortality across all age groups. Still, their underlying pathogenesis remains~          incompletely understood.~        -  Using a metabolomics approach, this study aims to characterise the spectrum of acids~          accumulating during acidosis, and investigate patterns of metabolic dysregulation~          associated with coma and seizures.~   "
85193|NCT02451891|"~     This is a clinical trial in which healthy volunteers will be administered experimental Ebola~     vaccines. The investigators will vaccinate four groups of volunteers.~      Group one will receive the MVA-EBO Z vaccine once at the dose of 1 x 10^8 pfu.~      Three groups will receive the prime vaccine cAd3-EBO Z followed by the boost vaccine, MVA EBO~     Z. The second group of volunteers will receive the boost vaccine after 14 +/-7 days at a dose~     of 1 x 10^8 pfu and the third and fourth group, after 28 +/- 7 days but at different~     concentrations of MVA-EBO Z (1 x 10^8 pfu for group 3 and 1.5 x 10^8 pfu for group 4).~      The study will assess the safety of the vaccinations, and the immune responses to~     vaccination. Immune responses are measured by tests on blood samples.~      The cAd3-EBO Z and MVA-EBO Z vaccines are called viral vectored vaccines. They are made from~     viruses which are modified so that they cannot multiply. The viruses have extra DNA in them~     so that after injection, the body makes Ebola proteins (but Ebola does not develop), so that~     the immune system builds a response to Ebola without having been infected by it.~      Healthy volunteers will be recruited in Oxford and London England. The study will be funded~     by the Wellcome Trust.~   "
85194|NCT02451878|"~     The investigators will test the value of an internet self-help package (E-Couch) for~     alleviating sub-clinical social anxiety symptoms in the general population. This is not a~     treatment trial for social anxiety disorder (these people will be directed to seek other help~     and excluded from this study). The investigators will undertake a randomised controlled trial~     involving approximately 2000 people with symptoms of shyness and sub-clinical social anxiety.~     The investigators will compare the effect of the E-Couch intervention compared to a wait-list~     control condition. Over a period of 12 months the investigators will measure the effect of~     using E-Couch self-help on social anxiety symptoms, as well as on mental wellbeing, and other~     secondary outcomes including quality of life, depression and general anxiety, and their use~     of other sources of help.~   "
85195|NCT02451865|"~     This phase Ib trial studies the safety and best dose of binimetinib when given in combination~     with docetaxel in treating patients with previously treated, stage IV non-small cell lung~     cancer. Binimetinib and docetaxel may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth.~   "
85196|NCT02451852|"~     To provide access to AZD9291 for adult patients with advanced/metastatic, epidermal growth~     factor receptor T790M mutation-positive non-small cell lung cancer.~   "
85197|NCT02451839|"~     For public health purposes disability is becoming increasingly important as an outcome~     measure. Despite this, there are few data on the effectiveness of adalimumab on disability~     outcomes in patients with Immune-Mediated Inflammatory Diseases (IMIDs), particularly in the~     Phase IV setting. There are even less data available in New Zealand, which did not have the~     opportunity to participate to a major extent in large, multinational, Phase III pivotal~     studies of adalimumab in IMIDs.~      The World Health Organisation Disability Assessment Schedule (WHODAS) 2.0 is a simple,~     validated, free and easy-to-use generic assessment instrument for health and disability. It~     is applicable across cultures, in all adult populations. It is a responsive measure that can~     show what difference a treatment makes.~      Results from study of effect of adalimumab on WHODAS scores and other Patient-Reported~     Outcomes (PRO) of work activity and well-being will be of interest to a variety of~     stakeholders in the healthcare system including patients, healthcare practitioners and~     payers.~   "
85198|NCT02451826|"~     The purpose of this study is to determine the effect of a contraceptive vaginal ring on~     inhibition of ovulation, endometrial changes and bleeding patterns in normal cycling women.~   "
85199|NCT02451813|"~     Recent evidence suggests that injection pressure monitoring may be able to predict needle~     nerve contact in the brachial plexus nerve block model, but little is known about~     multifascicular nerves. The investigators hypothesize that injection pressure monitoring can~     reliably predict needle-nerve contact during femoral nerve block.~   "
85200|NCT02451800|"~     The overall aim of the proposed study is to determine the effectiveness of a 3-month yoga~     program on increasing compliance and improving weight loss while participating in the Sanford~     Profile program. Participants are randomized to one of three groups: in-class yoga, yoga by~     digital video disk (DVD), stretching by DVD. Changes in weight loss and stress levels are~     monitored.~   "
85231|NCT02451397|"~     A large-scale, community-based, cross-sectional study was conducted to evaluate the extent to~     which lifestyle was associated with osteoporosis among the Chinese population by using~     self-reported questionnaire methods.~   "
85201|NCT02451787|"~     The investigators major aims are to: determine the vitamin D status of a group of young,~     apparently healthy adults in Hong Kong; examine inter-relationships between vitamin D status~     and biomarkers of DNA damage and repair, oxidative stress, inflammation and endothelial~     health; and, in part 2 of the study, investigate effects of improvement in vitamin D status~     on these biomarkers and other measures of well-being in those young adults shown to be~     deficient in vitamin D.~   "
85202|NCT02451774|"~     Recent advances in acute lymphoblastic leukemia treatment are based on a cytotoxic drug~     combination. Measurement of minimal residual disease in bone marrow samples at day 14 of~     treatment is the most powerful early predictive indicator of further relapse, and it can be~     applied practically to all patients with acute lymphoblastic leukemia. Even more so, it has~     been observed that patients who present negative minimal residual disease in bone marrow~     samples at day 7 during induction have a better prognosis than those achieving this at day~     14.~      Relapse represents the main cause of treatment failure that related in the extreme with~     resistance to apoptosis, defining the latter as the principal mechanism of programmed cell~     death; it is also related with the induction of leukemic cells to senescent arrest.~      Pentoxifylline is a methyl-xanthine byproduct considered an unspecific inhibitor of~     phosphodiesterase. It inhibits nuclear factor-kappa-beta activation by different mechanisms~     and stimulates apoptosis induced by different drugs; thus, it can optimize the antineoplastic~     effect of actual treatments in order to increase the apoptosis of leukemic cells. This effect~     might improve the prognosis of these patients.~      Evaluate the safety and effect of Pentoxifylline together with antineoplastic drugs in order~     to study increased apoptosis and decreased senescence during the remission induction phase in~     pediatric patients with newly diagnosed acute lymphoblastic leukemia. To achieve this~     propose, we will divide patients in two groups, who will receive pentoxifylline or placebo~     depending on the group, in addition to conventional treatment according to the protocol~     standard chemotherapy schema for pediatric patients with acute lymphoblastic leukemia at our~     institution during the remission induction phase. In addition, we will test whether the study~     group exerts an impact on reaching remission earlier as compared with the control group.~   "
85203|NCT02451761|"~     Apparently balanced chromosomal rearrangement (ABCR) associated with an abnormal phenotype is~     a rare but problematic event. It occurs in 6% of de novo reciprocal translocations and 9% of~     de novo inversions. Abnormal phenotype, including intellectual disability and / or multiple~     congenital anomalies (ID/MCA) may be explained either by associated cryptic genomic~     imbalances detectable by array-CGH or by gene disruption at the breakpoint. However,~     breakpoint cloning using conventional methods (i.e., fluorescent in situ hybridization~     (FISH), Southern blot) is often laborious and time consuming and cannot be performed~     routinely. Without complete investigation of these rearrangements, genetic counseling is a~     real challenge. Recently, the investigators and others showed that Next-Generation Sequencing~     (NGS) is a powerful and rapid technique to characterize ABCR breakpoints at the molecular~     level.~      The ANI project (ABCR NGS ID) aims at characterizing at the molecular level ABCR in 55~     patients presenting with intellectual disability and/or multiple congenital anomalies~     (ID/MCA) using NGS. The investigators make the hypothesis that ABCR account for the patient~     phenotype, either by gene disruption or position effect, since genomic imbalance would have~     been previously excluded by array-Comparative Genomic Hybridization (CGH).~      The ANI project is a 3-year-long study that will be conducted by a consortium of 21 partners,~     including 19 french hospital cytogenetics laboratories, a research team (TIGER), and a~     cellular biotechnology center. Patients will be recruited by each Cytogenetics laboratory.~     ABCR breakpoints will be molecularly characterized by NGS and a first bio-informatics~     analysis. The results will be verified by amplification of junction fragments by polymerase~     Chain Reaction (PCR) followed by Sanger sequencing, allowing the localization of breakpoints~     at the base-pair level. In some complex cases, FISH experiment will be necessary to clarify~     the results. A second bio-informatics analysis will then determine breakpoints'~     characteristics (sequence, repeated elements, gene and regulatory elements). Finally, for~     each breakpoint, gene expression studies will be performed including the gene disrupted by~     the breakpoint and two neighboring genes. All these data, together with those already~     available in the literature and databases will be integrated to determine if the gene could~     account for the patient's phenotype, allowing an appropriate genetic counseling.~      This project will identify new candidate genes involved in ID and developmental anomalies. It~     will also contribute to the development and evaluation of NGS as a diagnostic tool for ABCR~     and ID/MCA. It will also allow unraveling mechanisms and functional consequences of ABCR, in~     particular in term of position effect.~      In conclusion, the ANI project will contribute to the improvement of diagnostic management~     and genetic counseling of patients with ID/MCA and ABCR. It will also contribute to the~     understanding of ABCR physiopathology and to the unraveling of pathway involved in~     development and brain function, thus improving genetic counseling for ID/MCA patients in~     general.~   "
85204|NCT02451748|"~     The purpose of the study is to better understand the factors present in the cells of inflamed~     joints of patients with arthritis that may cause rheumatoid arthritis. Knowledge gained from~     this study may lead to new and better therapies for arthritis.~   "
85205|NCT02451735|"~     The purpose of this study is to review and evaluate the effectiveness of new educational~     materials (informational booklet & DVD) that promote participation in genetic counseling~     among breast cancer survivors.~      There are two phases to this study:~      Part 1 - reviewing the newly developed educational materials, and Part 2 - evaluating the~     effectiveness of the newly developed educational materials~   "
85206|NCT02451722|"~     Comparison and evaluation of pressure distribution, gait pattern, changes in the movement of~     the center of pressure, shock absorbing capabilities and comfort of wear using KyBoot shoes~     versus normal foot wear in diabetic and healthy subjects.~   "
85207|NCT02451709|"~     To determine whether electronic adherence monitoring with feedback and reminder alarms can~     improve adherence and health outcomes in childhood asthma.~   "
85208|NCT02451696|"~     The purpose of this study is to measure if the drug called Everolimus effects mTOR signaling~     (an electrical activity signal in the brain) in patients with Tuberous Sclerosis Complex~     (TSC) and Focal Cortical Dysplasia (FCD) with treatment resistant epilepsy (TRE) who will be~     undergoing brain surgery. One group of patients will be treated with Everolimus, and another~     will not. Researchers will determine if there is a difference in mTOR signaling between the~     patients who were treated with Everolimus and those who were not. Previous studies have~     suggested that Everolimus may reduce seizure activity in TSC patients by decreasing mTOR~     signaling. Since patients with FCD may also have excess mTOR signaling brain activity,~     Everolimus may also reduce seizure activity in these patients.~      The drug Everolimus is approved by the Food and Drug Administration to treat specific types~     of breast, pancreatic, and kidney cancer, a kidney tumor called an angiomyolipoma (common in~     patients with TSC), and TSC patients who have a brain tumor called a subependymal giant cell~     astrocytoma (SEGA). However, in this research it is considered to be an investigational since~     it is not approved for reduction in mTOR signaling and a decrease in seizure frequency.~     Researchers believe that Everolimus may be useful in reducing something called cortical~     hyperexcitability, which is the excess brain activity that can contribute to seizures.~   "
85209|NCT02451683|"~     The investigator's overall goal is to develop new strategies to enhance the recovery of~     upper-limb function after spinal cord injury (SCI). The investigator proposes to use modern~     electrophysiological methods to enhance the efficacy of residual corticospinal connections.~     Defining the neural basis by which corticospinal volleys generate muscle responses will~     provide crucial information required to maximize residual motor output. The investigator's~     specific goals are to: 1) determine the temporal and spatial organization of corticospinal~     volleys and motor cortical representations of upper-limb muscles after incomplete cervical~     SCI and 2) develop methodologies to promote recovery of function. The investigator's focus on~     reach and grasp movements because of their importance in daily life activities.~   "
85210|NCT02451670|"~     This project will test the ability of an electronic medical record-based clinical decision~     support system to help primary care providers identify, provide more appropriate care for,~     and control Cardiovascular risk factors for patients with Serious Mental Illness.~   "
85211|NCT02451657|"~     The aim of this study is to assess the suitability of selected scales (floor/ceiling effects,~     variability, test-retest reliability) to measure cognitive function in children with Down~     syndrome over 6 months, and to evaluate the influence of covariates such as age, gender or~     language on these neurocognitive scales.~   "
85212|NCT02451644|"~     The study examines the association between the amount of physical activity of the patient, ie~     the number of steps daily / weekly, and the pregnancy rate after embryo transfer.~   "
85213|NCT02451631|"~     A Multi-center, Randomized, Parallel, Open Clinical Trial to Evaluate the Glycemic Control~     Effect of the Mobile Healthcare Service Using U-Healthcare Clinical Decision Support System~     (CDSS) and U-Healthcare Gateway in Patients with Type 2 Diabetes Mellitus~   "
85214|NCT02451618|"~     For any newborn that exhibits possible seizure activity or has altered mental status of~     unknown etiology, continuous bedside EEG recording is the standard of care to detect~     subclinical seizure activity. The experimental aspect of this study will be the application~     of test electrodes (EES or EKG) to evaluate if the electrodes can be used to produce a~     continuous bedside recording of brain activity in the same manner as an EEG recording, while~     ideally producing less irritation of newborn skin than conventional EEG electrodes.~   "
85215|NCT02451605|"~     Comparison of the analgesics blocks (femoral, adductor canal and sciatic subgluteal nerve)~     for total replacement knee surgery.~   "
85219|NCT02451553|"~     This phase I/Ib trial studies the side effects and best dose of afatinib dimaleate when given~     together with capecitabine in treating patients with solid tumors, pancreatic cancer, or~     biliary cancer that has spread to other places in the body and usually cannot be cured or~     controlled with treatment and has not responded to previous treatment. Afatinib dimaleate may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs~     used in chemotherapy, such as capecitabine, work in different ways to stop the growth of~     tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them~     from spreading. Giving afatinib dimaleate together with capecitabine may be a better~     treatment for solid tumors, pancreatic cancer, or biliary cancer.~   "
85220|NCT02451540|"~     In this study the efficacy of Roflumilast in addition to LAMA/LABA therapy will be assessed~     using Functional Respiratory Imaging.~      In total 40 Chronic obstructive pulmonary disease (COPD) patients, Global Initiative for~     Chronic Obstructive Lung Disease (GOLD) stages C and D, who are stable on LABA/LAMA therapy~     and who are prone to dynamics hyperinflation will be included in this study. To indicate the~     susceptibility to dynamics hyperinflation patients should have a baseline Borg Fatigue score~     after the 6-minute walk test (6MWT) above 4.~      The patients will be randomized in such a way that 1 out of 2 patients will receive placebo~     and 1 the active component.~      Image parameters will be assessed and the correlation with lung function and health related~     quality of life will be checked before and after treatment.~   "
85221|NCT02451527|"~     The purpose of this study is to evaluate the pharmacokinetic study of the combination of~     digoxin and polythylene glycol loxenatide injection (PEX168) in healthy adults，and to provide~     scientific basis for clinical combination of PEX168 and drugs.This study is also to evaluate~     the safety and tolerability of mono-digoxin or digoxin plus PEX168.~   "
85222|NCT02451514|"~     The purpose of this study is to evaluate persistence of bactericidal antibodies for N.~     meningitidis serogroups A, C, W, and Y and serogroup B test strains approximately 4 years~     after primary vaccination in subjects who previously received a 2-dose series of~     MenABCWY+Outer membrane Vesicles (OMV) or a single dose of MenACWY, to evaluate immune~     response against N. meningitidis serogroups A, C, W and Y and serogroup B test strains 30~     days after a dose of MenABCWY+OMV in previously vaccinated subjects, and 30 days after a~     2-dose series in vaccine-naive subjects of similar age, to evaluate kinetics of immune~     response at 3, 7, and 30 days after a booster dose of MenABCWY+OMV in previously vaccinated~     subjects and to explore differences in the kinetics of immune response 3, 7 and 30 days after~     an accelerated 2 dose series of MenABCWY+OMV separated by 30 days given to vaccine-naive~     subjects, and to assess immunogenicity of 2 doses of MenABCWY+OMV at Day 61 in vaccine-naive~     subjects and subjects who previously received one dose of MenACWY~   "
85223|NCT02451501|"~     To compare deposition in two different positions.~   "
85224|NCT02451488|"~     Randomized trial to determine if neo-adjuvant subcutaneous GM-CSF restores the host regional~     lymph node immunity~   "
85225|NCT02451475|"~     Background: The investigator hypothesized that the combined use of pregabalin and paroxetine~     would be associated with comparable Somatic Symptoms Scale-8 (SSS-8) and higher tolerability~     than amitriptyline or venlafaxine.~      Methods: After ethical approval, 75 patients with diagnosed fibromyalgia who were receiving~     pregabalin 75 mg/day, were randomly allocated to receive amitriptyline 25 mg/day (n = 24),~     venlafaxine 75 mg/day (n = 25), or paroxetine 25 mg/day (n = 26). All patients were assessed~     bi-monthly for consequent six months for the changes in the SSS-8, Center for Epidemiological~     Studies Depression Scale (CESDS), life satisfaction, mood, sleep quality, fatigue and~     medication tolerability and adverse effects.~   "
85226|NCT02451462|"~     Patients who undergo bone marrow transplant for different types of cancer are exposed to many~     treatments such as steroids and whole body radiation. These treatments make the transplant~     possible but also make their bones weaker and more prone to fractures which can be a source~     of significant disability and decreased quality of life for cancer survivors. Our trial will~     investigate whether giving one dose of Zoledronic acid (a commonly used drug given to~     preserve bone mass in osteoporosis) before bone marrow transplant can protect from the bone~     loss caused by the transplant procedures. The investigators are also interested in studying~     the complex interactions of bone, muscle and fat which are greatly affected after bone marrow~     transplant.~   "
85227|NCT02451449|"~     The purpose of this study is to estimate the prevalence of celiac disease in a population of~     men and women newly referred to fertility treatment in Danish public fertility clinics.~   "
85228|NCT02451436|"~     This study aims to assess the effects of a sleep and media intervention on adolescents'~     overall health.~   "
85229|NCT02451423|"~     This is a single arm, open label Phase II study of MPDL3280A, an anti-PD-L1 antibody~     administered as neoadjuvant therapy to subjects with either BCG-refractory non-muscle~     invasive transitional cell carcinoma (TCC) of the bladder, or muscle-invasive TCC appropriate~     for cystectomy and refusing or ineligible for neoadjuvant chemotherapy. Enrolled patients~     will be assigned sequentially to dose levels in cohorts of 6 patients per dose level. The~     starting dose level is 1200mg x 1 dose and will be escalated in subsequent cohorts to 1200mg~     q 3 weeks x 2 doses, and finally 1200mg q 3 weeks x 3 doses to determine the impact of~     increasing number of treatments on the modulated immune response with the tumor tissue.~     Subjects with adverse pathology (pT3/pT4 or N+) will be offered the option of adjuvant~     MPDL3280A for up to 16 cumulative cycles of treatment.~      After all neoadjuvant study therapy is administered, each subject will undergo cystectomy to~     evaluate pathologic response to treatment and for immunologic characterization in the~     resected tissue. Serum and urine will be obtained as well to characterize circulating immune~     responses. After the multi-dose portion of the study has completed accrual two expansion~     cohorts of up to 15 patients each with NMIBC or MIBC will be accrued at the highest dose~     level for further characterization of safety, efficacy, and immunologic analysis. Patients~     with pT3, pT4, or N+ disease at the time of cystectomy and no metastatic disease will be~     offered the option of adjuvant MPDL3280A for up to a total of 16 cumulative cycles. All~     subjects will be followed clinically for up to 2 years to assess for disease recurrence.~   "
85230|NCT02451410|"~     The aim of this study is to design and evaluate an educational and behavioral intervention~     focused on improving nutrition and physical activity habits among preschoolers in Cuenca,~     Ecuador, with the overarching goal of preventing overweight/obesity and promoting the~     formation of healthy nutrition/physical activity habits.~   "
85233|NCT02451371|"~     The purpose of this study is to exploratively evaluate the efficacy and safety of~     transcranial direct current stimulation (tDCS) in patients with schizophrenia who experience~     persistent auditory verbal hallucinations after adequate antipsychotics therapy for over~     three months.~   "
85234|NCT02451358|"~     The aim of the study was to generate immunogenicity and safety data in the whole population~     to support registration of the Quadrivalent Influenza Vaccine (QIV) in India:~      Primary objective:~        -  To describe in each age group the immune response induced by a single injection~          (participants aged >9 years) or 2 injections (participants aged 6 months to 8 years) of~          QIV.~      Secondary objective:~        -  To describe in each age group the safety profile of QIV.~   "
85235|NCT02451345|"~     A UCSF PI-initiated study with a primary goal to improve decision quality, anxiety, and~     uncertainty, thereby increasing appropriate uptake of active surveillance and reducing~     over-treatment of low-risk prostate cancer.~      This study involves: completion of questionnaires through the secure website; consultation by~     a health coach to aid men with prostate cancer in making informed treatment decision~     (personalized coaching session(s)).~   "
85236|NCT02451332|"~     Preventing poor perinatal outcomes is the goal of all prenatal care, yet just who will go on~     to develop preeclampsia or have a growth-restricted baby is notoriously difficult to predict.~     A growing body of evidence suggests inflammatory markers can help predict poor outcomes, even~     prior to, and beyond, the current pregnancy. Our project will measure the response of one~     robust inflammatory marker, C-reactive protein (CRP), to a safe immune provocation~     recommended for all pregnant women (the seasonal influenza vaccine), and to find out whether~     CRP response is associated with increased risk for gestational hypertension, preeclampsia,~     preterm delivery, or birth weight. This work will help inform whether inflammatory markers~     should become part of routine prenatal care.~   "
85237|NCT02451319|"~     To compare the safety and Efficiency of 20w 30w holmium laser device in treatment of 1-2 cm~     diameter kidney stones with Retrograde Intrarenal Surgery (RIRS).~   "
85238|NCT02451306|"~     Bipolar disorder (BPD) is often misdiagnosed as unipolar depression. This leads to inadequate~     treatment and can have negative impact on the course of the disease. There is now preliminary~     evidence that patients with unipolar and bipolar depression as well as healthy individuals~     with a heightened risk of BPD can be distinguished from each other based on their brain~     activity patterns and functional connectivity during resting state.~      However, the impact of pharmacological treatment on these functional brain measures have not~     yet been clarified. For common antidepressants it has been shown that they seem to normalise~     aberrant brain activity patterns and functional connectivity. The problem is that some~     antidepressants can induce mania or accelerate pathological cycling in depressive patients~     with unrecognised BPD. Therefore, pharmacological drugs with mood-stabilising properties such~     as quetiapine are more and more prescribed. Although the effectiveness and tolerability have~     been proven, the neuronal effects of these adjunctive treatments are not clear. The aim of~     the study is thus to investigate the impact of quetiapine on measures of brain activity in~     depressive patients with a heightened risk of BPD. Moreover, the investigators want to~     examine whether the investigators can distinguish depressive patients with a heightened risk~     of BPD from depressive patients without a heightened risk of BPD using neuroimaging~     techniques, and whether these measures can predict the course of the disease.~   "
85239|NCT02451293|"~     The objective of the study is to investigate whether prophylactic treatment with melatonin~     has an effect on depressive symptoms. Secondarily melatonin's effect on anxiety, sleep and~     circadian disturbances will be investigated.~      The MEDACIS trial is a randomised, placebo-controlled, double-blinded multicenter trial~     investigating the effect of 25 mg exogenous melatonin (intervention group) against placebo~     (control group) and the study is designed as a parallel group superiority trial.~   "
85240|NCT02451280|"~     The aim of the project is to compare the effects of unilateral hybrid therapy [unilateral~     robot-assisted therapy (RT)] + unilateral arm training (UAT)] and bilateral hybrid therapy~     [bilateral RT + bilateral arm training (BAT)] on motor function, daily function, mobility,~     life quality, and motor control strategy in stroke patients.~   "
85241|NCT02451267|"~     The aim of the study is to investigate the effect of aerobic exercise on chronic neck pain.~     The study will be double blind randomized controlled trial . 120 patients with neck pain will~     be recruited for the study and divided into a research group and control group. The research~     group will receive neck exercise program with neck massage and aerobic exercise (leg~     bicycling with relaxed shoulders) and the control group will receive only neck exercise~     program with neck massage. Both intervention will be delivered by physiotherapist over 10~     treatments and will include a home exercise program. In addition, clinical prediction rule~     (CPR) for identifying patients with neck pain who will respond better to an aerobic treatment~     program will be defined.~   "
85242|NCT02451254|"~     Atrial fibrillation confers up to 5-fold increased risk of stroke in the absence of valvular~     heart disease. Although epidemiological studies have linked various clinical and~     echocardiographic risk factors to stroke, the exact mechanism of increased risk of stroke in~     AF remains poorly understood. Previous reports have suggested that loss of effective atrial~     contraction because of AF is associated with thrombogenesis. Microthrombi are most likely to~     form in the left atrial appendage. In contrast, intravascular thrombotic events in patients~     without AF are generally associated with abnormalities of vascular endothelial function~     and/or the coagulation system. On the assumption that more than 90% of all cardiac thrombi in~     patients with AF form in the LA appendage, and the fact that thrombi have been identified in~     15-20% of patients with AF who have clinical risk factors for ischemic stroke, it has been~     deemed to be our most lethal attachment. Administration of anticoagulant therapy is~     generally thought to be necessary as a preventive measure for patients at high risk of~     thromboembolism, but data indicating inadequate implementation of this highly effective~     therapy]. Several studies have found regional differences in platelet activation and~     hypercoagulability in the LA compared with systemic circulation in patients with valvular and~     nonvalvular AF, suggesting local contributing factors. Animal studies have demonstrated~     increased platelet activation and endothelial dysfunction with acute AF. The ability of~     antiplatelet agents to reduce the risk of cardioembolic events in AF suggests that platelets~     may contribute to the pathophysiology. Platelet activation occurs with AF and rapid atrial~     pacing, providing a possible mechanistic link. Other biomarkers that have proposed to improve~     the prediction of thromboembolotic events in this patient population include von Willebrand~     factor and D-dimer and cerebral imaging. A comprehensive understanding of the~     pathophysiological sequence leading to thrombus formation in the LAA of patients with AF~     could be helpful to characterize those at high risk for thromboembolic events, and~     subsequently to optimize the management of high risk patients.~   "
85412|NCT02449044|"~     This study will assess the safety of long-term tolvaptan use in patients previously enrolled~     in shorter-term Phase 3 studies and gather information on the natural history of hyponatremia~     in the context of tolvaptan therapy and underlying disease states.~   "
85243|NCT02451241|"~     Recent evidences from small studies show potential benefit of acupuncture in the treatment of~     obstructive sleep apnea (OSA). These studies did not evaluate the benefit of the treatment on~     the cardiovascular system.~      Primary end-point:~      To investigate the effects of acupuncture in improving OSA severity among hypertensive~     patients.~      Secondary end-point To investigate the effect of acupuncture in improving the quality of life~     and sleep assessed by the Short Form 36 (SF-36) questionnaire and Pittsburgh Questionaire~     (PSQI); To investigate the effect of acupuncture in blood pressure and arterial stiffness~   "
85244|NCT02451228|"~     This study will follow pregnant women who are taking indomethacin for preterm labor to find~     out the pharmacokinetics (what the body does to the drug) and pharmacodynamics (effectiveness~     of the drug in treating the specific intended disease process) of this medication. This will~     help us develop more information for medication dosing specific to pregnant women~     experiencing preterm labor.~      Indomethacin is often prescribed to pregnant women presenting with preterm labor or shortened~     cervix, which places them at risk for preterm labor and delivery. Indomethacin has been used~     since the 1970s to prolong pregnancy by decreasing uterine contractions. However, despite the~     widespread use of indomethacin in pregnancy, there is limited information available to help~     physicians determine how much indomethacin to prescribe and how often to prescribe it.~   "
85245|NCT02451215|"~     Laser Interstitial Thermal Therapy (LITT) is a minimally invasive surgical technique that~     allows for biopsy and thermal ablation of brain tumors. Pediatric patients with brain tumors~     who are eligible and enroll in the trial will undergo LITT at the time of diagnosis or at the~     time of recurrence/progression rather than undergo an open craniotomy and tumor~     resection/biopsy. LITT will include a stereotactic biopsy followed by thermal ablation of the~     tumor. This study will monitor the safety and efficacy of LITT for the treatment of pediatric~     brain tumors.~   "
85246|NCT02451202|"~     It is unknown the impact of deep neuromuscular paralysis and using a novel agent, sugammadex~     as an reversal in endolaryngeal surgery.~      We will conduct a clinical study aiming to compare two treatment strategies; Deep~     neuromuscular Blockade and moderate Neuromuscular Blockade. We hypothesize that deep NMB will~     offer better stillness. We will also descriptively examine if patients would be safely~     discharged from a recovery room.~   "
85247|NCT02451189|"~     Obesity, with its associated co-morbidities, is a major public health challenge. It is~     estimated that by 2050, 60% of men and 50% of women will be clinically obese. Obesity is~     associated with increased risk of developing diabetes, cardiovascular disease, and certain~     cancers. The increasing epidemic of obesity has necessitated the study of the complex~     mechanisms underlying energy homeostasis. Food intake, energy balance and body weight are~     tightly regulated by the hypothalamus, brainstem and reward circuits, on the basis both of~     cognitive inputs and of diverse humoral and neuronal signals of nutritional status. Several~     gut hormones, including glucagon-like peptide-1 (GLP-1) and peptide YY3-36 (PYY), have been~     shown to play an important role in regulating short-term food intake. Peripheral~     administration of PYY or GLP-1 enhances satiety and reduces food intake in animals and man.~     PYY, GLP-1 along with a host of other hormones are produced by the gut in response to~     nutrient availability in different regions of the gut and provide an exquisite mechanism of~     nutrient sensing in response to dietary intake. These hormones therefore represent potential~     targets in the development of novel anti-obesity treatments. A novel and attractive strategy~     to induce appetite regulation is the enrichment of foods with components that stimulate the~     release of GLP-1 and PYY. The short chain fatty acids (SCFA) produced by microbial~     fermentation of dietary fibre in the colon have been shown to stimulate the release of PYY~     and GLP-1 from rodent enteroendocrine L cells, via stimulation of the G-protein coupled free~     fatty acid receptors (FFAR) on colonic L cells. However, it is not known whether the three~     SCFA, acetate, butyrate and propionate, differentially affect appetite and glucose control.~     The aim of this study is to compare the effects of increased colonic delivery of acetate,~     butyrate and propionate on appetite and glucose control in overweight men in a randomised~     crossover study.~   "
85248|NCT02451176|"~     This study will compare the safety, efficacy and cost effectiveness of a permanent synthetic~     mesh versus a biologic prosthesis for the repair of ventral hernias in the setting of~     clean-contaminated (Class 2) or contaminated (Class 3) surgical procedures. The findings of~     this study will have a major impact on the field of hernia surgery as it will provide~     objective guide to mesh selection, optimize surgical approaches for complex ventral hernia~     repair, and ultimately significantly improve patient outcomes.~   "
85249|NCT02451163|"~     The aim of the study is to measure the effect of wheat polysaccharides on the occurence of~     common cold (CC) in elderly during a 12-week consumption period.~   "
85250|NCT02451150|"~     The purpose of this study is to evaluate the pharmacokinetics and safety of a single dose of~     TAK-536 (azilsartan) in pediatric patients aged 6 to less than 16 years with hypertension.~   "
85251|NCT02451137|"~     Primary Objective:~      Demonstrate clinical benefit of Toujeo in achieving individualized HEDIS HbA1c targets (<8%~     if age 65 years or with defined comorbidities (as listed in Appendix G) or otherwise <7%) at~     6 months without documented symptomatic (BG 70mg/dl) hypoglycemia at any time of day from~     baseline to 6 months in uncontrolled insulin naive patients with type 2 diabetes initiating~     basal insulin therapy in a real world setting.~      Secondary Objectives:~      Compare Toujeo to other commercially available basal insulins at 6 and 12 months after~     initiating insulin therapy in a real world setting in terms of:~        -  Patient persistence with assigned basal insulin therapy~        -  Risk of hypoglycemia including the incidence and rate of documented symptomatic and~          severe hypoglycemia~        -  Changes in HbA1c, fasting plasma glucose, body weight~        -  Differences in patient- and provider- reported outcomes (including Diabetes Treatment~          Satisfaction Questionnaire Status and Change Versions DTSQs and DTSQc), Hypoglycemia~          Patient Questionnaire, and patient and provider reported Global Effectiveness Scale~          (GES)~        -  Healthcare resource utilization including hospitalizations and emergency department or~          other provider visits and healthcare costs.~   "
85252|NCT02451124|"~     This pilot clinical trial studies non-endoscopic brushing of the esophagus using a~     non-endoscopic inflatable balloon for the esophagus in screening for Barrett esophagus, a~     condition where the lining of the esophagus has changed or been replaced with abnormal cells~     that may lead to cancer. The non-endoscopic inflatable balloon for the esophagus is a capsule~     balloon that brushes against the walls of the esophagus to collect esophageal samples.~     Non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the~     esophagus may help doctors find Barrett esophagus sooner, when it may be easier to treat.~   "
85414|NCT02449018|"~     To evaluate the efficacy, safety and tolerability of multiple doses of QBW251 vs placebo~     administered orally, on airway function, lung volume, and quality of life in patients with~     chronic obstructive pulmonary disease (COPD)~   "
85253|NCT02451111|"~     Follicular lymphomas FL has been traditionally approached either by an initial watch and wait~     policy in the asymptomatic patient, or with single agent treatments with the purpose of~     maintaining a good quality of life for a prolonged time.The combination of rituximab and~     ibrutinib has been tested in clinical trials and appeared to be well tolerated and active.~     Since ibrutinib seems to achieve better results when administered for prolonged time as shown~     in CLL, the investigators have chosen to compare its combination with rituximab to the~     prolonged rituximab-only schedule that was already shown to be very active in the SAKK 35/03~     trial.~      The aim of the study is to investigate the efficacy, safety and tolerability of the treatment~     combination of Ibrutinib and Rituximab for patients with advanced follicular lymphoma in need~     of therapy.~   "
85254|NCT02451098|"~     A Multicenter, Randomized, Double-blind, Active-controlled, Parallel group, Factorial Design,~     Phase III Clinical Trial.~   "
85255|NCT02451085|"~     The purpose of the present study is to examine whether an intervention plan based on exercise~     through remote rehabilitation system leads to improvement in characteristics of walking and~     balance among patients after hip replacement surgery compared to the current conventional way~     of exercise among these patients.~   "
85256|NCT02451072|"~     Aim of the present study is to investigate the neuronal correlates of self and of personal~     meaning as well as the role of the serotonin (5-HT) 2A receptor system in these processes~     using functional magnetic resonance imaging (fMRI) and psychometric and cognitive measures.~   "
85257|NCT02451059|"~     This research project is aimed to assess the effectiveness and impact of a pediatric-based~     intervention aimed at reducing low-income families' unmet material needs (food, housing,~     employment, childcare, household heat, education and learning the English language ) on child~     health.~   "
85258|NCT02451046|"~     The primary objective of this study was to evaluate the ability of plasma alpha-GST~     measurements in liver donor (at the time of organ removal) to predict primary dysfunction in~     liver recipient. The secondary objective was to study the relationship between alpha-GST~     levels in the plasma of the liver transplant recipient and early graft function recovery.~   "
85259|NCT02451033|"~     Cirrhosis of liver is a leading cause of morbidity and mortality worldwide . Complications~     including ascites, spontaneous bacterial peritonitis (SBP), variceal bleed, hepatic~     encephalopathy, hepatorenal syndrome (HRS) and development of hepatocellular carcinoma (HCC)~     have poor prognosis and further decreases the survival in these patients. It has been~     believed that cirrhosis is irreversible and that treatment should focus on preventing the~     progression of liver fibrosis/dysfunction and its complications.~      Currently the only effective treatment is liver transplantation, an increasingly limited and~     expensive resource especially in developing countries. Furthermore, transplantation comes~     with a requirement for lifelong immunosuppression, and considerable long-term side effects~     that include chronic renal failure, post-transplant lymphoproliferative disease, and~     cardiovascular complications.~      Short of liver transplant, recently, reports of unexpected plasticity in adult bone marrow~     have raised hopes that stem cell therapy may offer exciting therapeutic possibilities for~     patients with end stage liver diseases. It has been shown that in response to acute or~     chronic liver damage, bone marrow derived stem cells can spontaneously populate the liver and~     differentiate into hepatic cells. Animal and human studies suggested that such cells might~     contribute to the regeneration after different kinds of liver injuries . In animal models,~     after liver injury, bone marrow-derived circulating pluripotent cells have been reported to~     participate in liver repopulation with both non-parenchymal cells and hepatocytes. This~     repopulation process, however, seems to be highly dependent on the type of liver injury and~     experimental conditions. Fusion with hematopoietic cells has been substantiated as a~     mechanism by which hepatocytes can regenerate, and studies have demonstrated improved liver~     histology and survival in patients with cirrhosis following mobilization of bone marrow stem~     cells by granulocyte-colony stimulating factor (G-CSF) . Three recent studies have~     demonstrated G-CSF induced mobilization of bone marrow stem cells (CD34 cells) in peripheral~     blood and their subsequent increase in liver tissue and improved survival in patients with~     alcoholic hepatitis and acute on chronic liver failure (ACLF) . However there is insufficient~     data on whether G-CSF improves survival and prognosis in patients with cirrhosis.~      Also, Malnutrition is commonly seen (60-70%) in cirrhotics and have adverse prognosis on its~     outcome . The protein catabolic state of cirrhosis is associated with severe growth hormone~     (GH) resistance, with low levels of insulin-like growth factor (IGF)-I and its major binding~     protein (IGFBP)-3 . GH therapy in cirrhosis have been shown to improve nitrogen economy and~     to improve the GH resistance in a small pilot study. Also, GH therapy of short duration has~     shown to increase IGF1 levels, IGFBP-3 levels in patients of cirrhosis . GH therapy has also~     shown to improve liver regeneration and protein synthesis after hepatectomy in patients of~     HCC with cirrhosis . However there is scarcity of data on clinical impact of long term~     administration of GH therapy in patients of cirrhosis.~   "
85260|NCT02451020|"~     The study evaluates respiratory acclimatization in healthy lowlanders staying for 3 weeks at~     3200 m.~   "
85261|NCT02451007|"~     Study to assess the potential effects of lurbinectedin (PM01183) at a therapeutic dose on the~     duration of the QTc interval, measured by electrocardiograms (ECGs), to characterize the~     PM01183 plasma concentration/QTc relationship, and to explore related ECG parameters in~     patients with selected solid tumors.~   "
85262|NCT02450994|"~     Randomized, placebo controlled trial evaluating efficacy of dexamethasone in preventing sleep~     related breathing disturbances in lowlanders with chronic obstructive lung disease travelling~     from 700 m to 3200 m.~   "
85263|NCT02450981|"~     This clinical study is a phase 1 study which carried out to to evaluate the safety,~     pharmacokinetics and tolerability of multiple intravitreal injections of BCD-021(bevacizumab~     biosimilar candidate manufactured by CJSC BIOCAD, Russia) when used in patients with~     neovascular wet age-related macular degeneration.~   "
85264|NCT02450968|"~     Randomized, placebo controlled trial evaluating efficacy of dexamethasone in preventing acute~     mountain sickness in lowlanders with chronic obstructive lung disease travelling from 700 m~     to 3200 m.~   "
85265|NCT02450955|"~     Objective. To compare the benefits of spinal manipulation combined with massage therapy~     versus massage alone in patients with tension-type headache (TTH) on the frequency, intensity~     and disability caused by headache and on cervical range of motion.~      Method. A factorial, randomized, double-blinded, placebo-controlled clinical trial was~     conducted with a sample of 105 subjects diagnosed with TTH, divided into two groups: a) the~     treatment group received a manipulative technique followed by massage of the cervical and~     suboccipital region; a) the control group received massage alone. Four sessions (once per~     week) were applied over four weeks. The Headache Disability Inventory (HDI) was used to~     evaluate changes in the frequency and severity of headache and functional and emotional~     aspects of headache. Range of upper cervical and cervical flexion and extension were~     evaluated. Measures were conducted at baseline, immediately after the intervention (week 4)~     and at a follow up 8 weeks after completion of the intervention.~   "
85266|NCT02450942|"~     This is an open-label dynamic whole-body PET/CT (positron emission tomography/computed~     tomography) study for investigation of radiation dosimetry, plasma pharmacokinetics,~     biodistribution, safety and diagnostic performance of 18F-FDS in healthy volunteers and~     patients with suspected infection. A single dose of nearly 370 MBq 18F-FDS will be~     intravenously injected into healthy volunteers and patients with suspected infection. Visual~     and semiquantitative method will be used to assess the PET/CT images. Changes of blood~     pressure, pulse, respiration, temperature, routine blood and urine tests, serum alanine~     aminotransferase, albumin, and creatinine, and any adverse events will be collected from the~     volunteers. Adverse events will also be observed in the patients.~   "
85267|NCT02450929|"~     This protocol is designed to determine if a transition from barrel-shaped cuff designs to the~     Taperguard endotracheal tube (ETT) reduces the incidence of postoperative pneumonia in a~     prospective evaluation of a large general, vascular, orthopedic, urologic and neurologic~     surgical population. The protocol was originally developed as a quality assurance project to~     evaluate a practice change that took place December 1, 2012. Data regarding postoperative~     pneumonia and related factors will be reviewed for the 18 months prior to the practice change~     and compared to data from the 14.5 months following the change. Since the results may be of~     interest to a wider audience, we are converting the project to a research study that may be~     published in the future.~      The study will include data from all adult patients who had surgery at OHSU between June 1,~     2011 and February 15, 2014. We anticipate that we will enroll approximately 40,000 subjects~     (at least 22,000 in the pre-intervention group and at least 16,000 in the post-intervention~     group). Data will be gathered from the OHSU electronic medical record system (Centricity and~     Epic).~      6. A multiple logistic regression analysis will be employed to determine the rates of~     pneumonia between the use of a standard barrel-cuff designed ETT and the Taperguard ETT for~     the defined group of surgical patients. The regression analysis would be adjusted for~     confounding variables including ASA status, age, use of paralytic, RSI with cricoid pressure,~     weight, pre-existing lung disease.~   "
85268|NCT02450916|"~     Objective: In addition to physical discomforts, work-related injuries and illnesses often~     result in various forms of hardships, including economic hardship, labor conflicts and legal~     disputes. The physical and psychological health conditions are likely to be worsen when the~     social supporting systems are not well functioning. In this study, the investigators aim to~     conduct in-depth interviews with injured workers to study their experiences with the social~     systems, including employment protection system, workers' compensation system, health care~     system and other social welfare systems, and to explore how the systems may affect workers'~     physical and psychological health.~      Methods: Face-to-face interviews will be conducted with a semi-structured questionnaire.~     Subjects who had ever experienced work-related injuries or diseases (including muscular~     skeletal disorders and work-related cardiovascular or cerebrovascular diseases) over the past~     3 years are invited. The investigators anticipate to recruit a total of 60~100 cases, whom~     will be recruited through the assistance of occupational physicians, occupational health~     centers, labor groups and unions. Interview time will be limited to 1 hour.~      Anticipated results and contribution: Findings of this study will help to advance our~     knowledge concerning the functions of current social systems and the hardships of workers who~     suffer from work-related injuries and diseases. Suggestions will be provided for the~     improvements of current systems.~      Keywords: work-related injury, occupational disease, workers' compensation, psychological,~     policy.~   "
85269|NCT02450903|"~     This is a single-arm, open-label, multicenter, phase II study to evaluate the efficacy and~     safety of the ALK inhibitor LDK378 when used as single agent in patients with ALK-rearranged~     stage IIIB or IV NSCLC previously treated with alectinib. Treatment with LDK378 750 mg qd~     will continue until the patient experiences disease progression as determined by the~     investigator according to RECIST 1.1, unacceptable toxicity that precludes further treatment,~     pregnancy, start of a new anticancer therapy, discontinues treatment at the discretion of the~     patient or investigator, lost to follow-up, death, or study is terminated by Sponsor.~   "
85270|NCT02450890|"~     The purpose of this study is to evaluate the safety and efficacy of ORADUR®-Methylphenidate~     in children and adolescents with ADHD.~   "
85271|NCT02450877|"~     This study is a randomized, multicenter, open-label, Phase 2 study that will be run in 2~     parts: a safety run-in part to determine the dose of azacitidine and then a second part to~     determine the efficacy of that dose in children and young adults with acute myeloid leukemia~     in molecular relapse after their first complete remission.~      Indication Treatment of children and young adults with molecular relapse of acute myeloid~     leukemia (AML) after first complete remission (CR1).~      Objectives Primary Objectives Safety Run-in Part To establish a safe and tolerable dose of~     azacitidine to be used in the randomized part of the study.~      Randomized Part To evaluate the effect of azacitidine treatment in AML subjects at molecular~     relapse after CR1 when compared to no treatment with regard to the progression-free rate~     (PFR) at Day 84 (±4 days) post randomization.~      Secondary Objectives Safety Run-in Part To establish azacitidine plasma pharmacokinetic (PK)~     parameters in subjects with molecular relapse AML after CR1 and to assess efficacy.~      Randomized Part To evaluate the safety, pharmacodynamics (PD), and efficacy of azacitidine~     treatment in subjects with molecular relapse AML after CR1.~      Study Design The population of this trial consists of children and young adults with AML who~     achieved a complete response (CR) with molecular remission, defined as Minimal Residual~     Disease (MRD) less than 5 x 10-4, following their initial induction therapy and who~     subsequently have a molecular relapse (defined as increase in MRD level by at least 1 log~     [10-fold] to a level greater than or equal to 5 x 10-4 despite a normal percentage [<5%] of~     myeloblasts in the bone marrow [BM] aspirate and peripheral blood [PB], and in the absence of~     proven histological extramedullary relapse). Eligible subjects have a documented diagnosis of~     AML with at least one of the following molecular aberrations t(8;21), RUNX1-RUNX1T1, inv(16),~     CBFb/MYH11, t(9;11), MLL-AF9, NPM1 mutation, or FLT3-ITD mutation. Enrolled/randomized~     pediatric subjects will be followed with regular MRD testing in order to detect a molecular~     relapse.~      In the safety run-in part, up to 12 subjects aged 3 months to less than 18 years will be~     enrolled. Six subjects will be enrolled in the first cohort of 100 mg/m2 azacitidine~     administered intravenously (IV) on Days 1 to 7 of a 28-day cycle. Six additional subjects~     could be enrolled into a second cohort of 75 mg/m2 azacitidine administered IV on Days 1 to 7~     of a 28-day cycle depending on the safety and tolerability results of the 100 mg/m2 cohort.~      In the randomized part of the study at least 68 subjects will be randomized (or more~     depending on whether at least 64 subjects are evaluable for the primary endpoint), with at~     least 60 of the subjects being less than 18 years of age.~      Both parts of the study, the safety run-in part and the randomized part, will contain 3~     periods: the screening period, the treatment period and the follow-up period. The screening~     period will last no more than 10 days in the safety run-in part after which the subjects may~     be enrolled and treated. In the randomized part, the screening period will last an indefinite~     amount of time until detection of a molecular relapse in the PB followed by confirmation of~     the relapse in both PB and BM aspirate, at which point the subject may then be randomized.~     Subjects will be treated with azacitidine (safety run-in part) or in accordance to their~     assigned treatment arm (randomized part). Upon discontinuation from the treatment period,~     subjects will enter into the follow-up period which will last up to 2 years from last patient~     enrolled/randomized.~   "
85272|NCT02450864|"~     Investigators recent data showed anti-inflammatory effect of Effect of Extracorporeal~     Shockwave Technology (ESWT). Little studies focused on the effect and pathomechanism of ESWT~     on shoulder stiffness.~   "
85273|NCT02450851|"~     Background:~      - Without an explanation for severe and sometimes life-threatening symptoms, patients and~     their families are left in a state of unknown. The NIH helped create a network of medical~     research centers, called the Undiagnosed Diseases Network (UDN), to provide care and answers~     for these individuals.~      Objectives:~      - To improve diagnosis and care for people with undiagnosed diseases.~      Eligibility:~      - People with undiagnosed diseases, and their relatives.~      Design:~        -  Participants will travel to one of the UDN medical centers for a 5-day clinical and~          research visit.~             -  As part of the visit, UDN healthcare providers may ask participants to have:~                  -  Clinically indicated tests and procedures performed including:~                       -  A physical exam~                       -  Blood and urine tests~                       -  A review of health and family history~                       -  X-rays and body scans~                       -  Surveys~                       -  Photographs of the face and body~                       -  A special diet to see if the body can handle the food without having a~                         reaction, like vomiting~                       -  Video or voice recordings~                       -  Other tests and procedures to help reach a diagnosis~                  -  Research tests and procedures performed including:~                       -  A skin biopsy. For this, a small piece of skin will be taken.~                       -  Surveys~                       -  Other tests and procedures for research that may not be related to a~                         diagnosis or treatment.~        -  Most participants will be asked to give samples for genetic testing.~        -  Participants may be contacted after their visit to discuss test results. They may also~          be contacted in the future for interviews and surveys.~        -  Relatives of participants may be asked to give samples for genetic testing. They may be~          asked to have parts of their visit recorded and to have additional tests. They may also~          be contacted in the future for interviews and surveys.~        -  Clinical and research information collected will be stored in a database.~        -  Information and samples collected will be shared with others for research purposes.~   "
85274|NCT02450838|"~     Dengue viruses are mosquito-borne flaviviruses. Each year, dengue viruses infect millions of~     people throughout the tropics and subtropics. This study will evaluate the safety,~     tolerability, and immunogenicity of a tetravalent recombinant subunit dengue vaccine (V180)~     in healthy adults who previously received a live-attenuated tetravalent dengue vaccine (TV003~     or TV005).~   "
85275|NCT02450825|"~     This study is designed to compare three ultrasound-based aeration scores that were previously~     validated in specific populations, and to assess their correlation with computed tomographic~     measurement of pulmonary aeration in a population with different pathologies.~      Hypothesis: The Loss of Aeration Score will be more accurate than a simplified version and~     another widely used score, the Lung Ultrasound Score.~   "
85276|NCT02450812|"~     This observational prospective single arm cohort study is designed to assess overall~     survival, symptomatic skeletal event free survival and quality of life of metastatic~     Castration Resistant Prostate Cancer (mCRPC) patients receiving Radium- 223 under real life~     conditions. In addition, time to next tumor treatment (TTNT), mobility, quality of life and~     selfcare, independence in activities of daily living and safety will be assessed.~   "
85277|NCT02450799|"~     The purpose of this study is to compare the long-term visual acuity (VA) with an acrylic IOL~     to a silicone or polymethylmethacrylate (PMMA) IOL in cataract patients. This study will take~     place in Japan.~   "
85278|NCT02450786|"~     There have been growing interest in identifying Parkinson's disease (PD) patients with mild~     cognitive impairment (MCI) which is susceptible to progress to PD dementia(PDD). PD-MCI is~     known to significantly correlates with low cerebrospinal beta-amyloid 1-42 and 1-40 levels,~     in which suggest the existence of something common with Alzheimer's dementia. PDD have showed~     more cholinergic deficits than Alzheimer's dementia and responds to donepezil. The~     investigators assume that PD-MCI patients also have cholinergic deficits. Donepezil improves~     cognition, and seems to be well tolerated and not to worsen parkinsonism in patients with~     cognitive impairment. Donepezil produced similar improvements in cognition and behaviour in~     DLB and PDD. This supports the hypothesis that the two disorders are closely related~     clinically and neurobiologically. Larger scale, placebo controlled clinical trials are needed~     to provide an evidence base to guide the clinical use of cholinesterase inhibitors in Lewy~     body disease.~      It is believed that earlier intervention, later appearance of dementia should be needed to~     lower the socioeconomic costs and to improve the quality of life on patients and caregivers.~     The investigators anticipate that donepezil may delay the development of dementia in patients~     with PD-MCI.~   "
85279|NCT02450773|"~     The purpose of this study is to determine whether postpartum administration of furosemide to~     women with antepartum hypertensive disorders (gestational hypertension, preeclampsia) or~     elevated blood pressure in the first 24 hours following delivery reduces severe postpartum~     hypertension.~   "
85280|NCT02450760|"~     The goal of this pilot project is to assess adherence with home blood pressure monitoring in~     hypertensive patients with a history of cerebral infarction and to determine if a social~     incentive improves adherence with monitoring. Enrolled subjects will all have a history of~     cerebral infarction and uncontrolled blood pressure, defined by SBP>140 or DBP>90 mm Hg at~     the time of enrollment. To be eligible subjects will also be required to own a smart phone~     (iOS or Android operating system). After enrollment, patients will be given a home blood~     pressure cuff with instructions to monitor their BP twice daily for 90 days. Subjects will be~     randomly assigned to a social incentive program, in which a social supporter receives updates~     via email and/or text message on the subject's adherence with BP monitoring and their average~     blood pressure. This study will provide important pilot data which will inform the design of~     future studies utilizing connected health and automated systems to improve home blood~     pressure monitoring and blood pressure control in patients with a history of stroke.~   "
85281|NCT02450747|"~     This is a four week study to evaluate the performance of a multifocal contact lens in~     habitual wearers of silicone hydrogel multifocal contact lenses.~   "
85282|NCT02450734|"~     Since stroke and myocardial ischemia are major causes of perioperative morbidity and~     mortality associated with carotid endarterectomy, monitoring the brain and ensuring the best~     hemodynamic stability are important goals of perioperative management.~      The investigators conducted a prospective observational study about efficacy and safety of~     the ultrasound-guided intermediate cervical plexus block (CPB), with early (immediate~     postoperative) and mid-term (day 30) outcomes in awake patients undergoing carotid~     endarterectomy.~   "
85283|NCT02450721|"~     Aim of the present study is to investigate molecular and clinical markers in patients with~     atherosclerotic carotid stenosis (ACAS) in the ischemic stroke acute phase.~   "
85284|NCT02450708|"~     This study tests whether adding certain genetic factors to the process of picking a stem cell~     donor can decrease the chances that the patient's leukemia will come back after bone marrow~     transplantation. Stem cell donors are matched based on genes called human leukocyte~     antigens (HLA).~      Currently, donors are selected largely on the basis of HLA gene typing alone. There is~     published data to show that donors with specific other genes called killer~     immunoglobulin-like receptors (KIR) may protect AML patients from having their leukemia~     return after a transplant. In this study, the best HLA matched donors will be tested for the~     KIR genes. If there is more than 1 donor available, a recommendation will be provided to~     study doctors as to which donors have potentially favorable KIR genes. The study doctors may~     or may not choose to use this donor for transplant or not based on his/her own judgment.~     Transplant care will not change otherwise as a result of this study.~      This study is being done to demonstrate that AML patients who have donors with specific KIR~     and HLA genes will have a better outcome following transplant.~   "
85285|NCT02450695|"~     This study will evaluate the effectiveness of rTMS as a potential treatment for refractory~     OCD in a randomized, crossover design.~   "
85286|NCT02450682|"~     This study is being done to determine if apixaban is more safe, when compared to warfarin, at~     reducing the risk of bleeding during CIED procedures.~   "
85287|NCT02450669|"~     Airway management in intensive care unit (ICU) patients is challenging. Benefit risk ratio of~     extubation has to be daily assessed in intubated patients.~      The investigators aimed to assess incidence and risk factors of airway failure after~     extubation procedure in critically ill patients in a prospective multicenter study.~   "
85288|NCT02450656|"~     This is a multi-center open-label proof-of-concept study consisting of two parts: PART A - a~     phase I dose-finding study (3 + 3 classical design) evaluating the RP2D of afatinib in~     combination with selumetinib in KRASm NSCLC; and PART B - a randomized phase II study~     investigating the progression free survival and safety of selumetinib/afatinib combination~     therapy compared to standard of care chemotherapy in KRASm NSCLC.~   "
85289|NCT02450643|"~     Infants/children with cow's milk allergy will take part in 2 double-blinded~     placebo-controlled food challenges (DBPCFC) of 2 extensively hydrolyzed formulas in random~     order. If both food challenges are passed, subjects will be asked to consume the Test formula~     in an at-home open challenge for 7 days.~   "
85290|NCT02450630|"~     Uganda's under-five mortality is high, currently estimated at 90/1000 live births (Uganda~     Bureau of Statistics 2011). Poor referral of sick children that seek care from the private~     sector is one of the contributory factors. The proposed intervention aims to improve uptake~     of referral advice for children that seek care from private facilities (registered drug~     shops/private clinics).~      The project will be implemented in Mukono district, central Uganda selected because a recent~     concluded trial in the district showed that drug shop vendors (DSVs) adhere to diagnostic~     test results, treat appropriately and refer sick children; although uptake of referral is~     poor. The main reasons attributed to the observed poor referral were negative attitude~     towards referral forms from drugs shops by the health workers at referral~     facilities,perceptions of poor quality of care at referral facilities and costs involved~     (Hutchinson. 2012; Hutchinson et al. 2013 in press)..~      Thus the proposed project is a follow up to address these factors with the aim to improve~     uptake of referral. This project is in line with the Uganda's Health sector and USAID~     Mission's health priorities of strengthening the health system. Critical barriers in the~     implementation of child survival interventions are poor quality of care in the private sector~     and timely referral and uptake of referral advice at community level. These barriers may be~     attributed to inadequate training of providers in the private sector (in diagnosis and~     management of childhood illnesses); inadequate supervision and regulation; poor linkages and~     collaboration between the public and private sectors; and non-existent linkages between~     community structures and the private sector. The barriers will be addressed through an~     intervention with three components; i) VHTs will be trained to do community sensitization and~     initiate community discussions aimed at identifying community support mechanisms for~     financial hardship (to be community led and managed) - e.g. communities to be encouraged to~     establish community credit/insurance schemes for referral VHTs will register children and~     facilitate follow up of sick children ii) supervision of providers in the private sector to~     diagnose, treat and refer sick children, iii) regular meetings between the public and private~     providers (convened by the district health team) to discuss the referral system.~   "
85291|NCT02450617|"~     The research project outlined in this proposal aims to investigate the effectiveness of~     stabilizing group treatment as an add-on to conventional treatment, for patients with Post~     Traumatic Stress Disorder (PTSD) or dissociative disorders after childhood abuse. The~     investigators also aim to study psychophysiological markers associated with complex trauma~     and treatment, mechanisms of change involved in treatment, and which patient characteristics~     that predict positive outcome.~   "
85322|NCT02450214|"~     Lipoabdominoplasty and liposuction are one of the most common plastic surgeries. The~     management of postoperative pain is complex. Non Steroidal Anti Inflammatory Drugs (NSAIDs)~     are insufficient, while opioids are avoided by their adverse effects and regional techniques~     are hampered by a premature discharge. In this context, the investigators seek an~     intraoperative multimodal analgesic technique blocking NMDA receptors with ketamine plus~     magnesium to significantly decrease postoperative pain.~   "
85292|NCT02450604|"~     Fabry disease is a rare inherited metabolic disorder that predominantly affects heart,~     kidneys and nervous system. Fabry disease has been searched in series of patients presenting~     different isolated signs caused by the affection of one of these organs. Acroparesthesias and~     chronic crises of pain of different origins are reported in the large majority of patients~     during the progression of the disease. Moreover, this signs are frequently inaugurating the~     disease. The investigators have previously performed a preliminary single-center study which~     permitted to identify one female patient with Fabry disease in a series of 147 consecutive~     patients with chronic pain tested. The investigators now propose to confirm the results of~     our preliminary study. The investigators plan to evaluate the prevalence of Fabry disease in~     a series of 1000 patients suffering from chronic pains of undetermined aetiology and~     consecutively recruited.~   "
85293|NCT02450591|"~     This study will test if local therapies in addition to erlotinib can improve responses and~     delay the time until new treatment is required. This study will also collect blood samples~     for research blood tests.~   "
85294|NCT02450578|"~     Study to evaluate the efficacy of DSM265 as a causal prophylactic in a standardized and~     validated Human Challenge model using direct venous inoculation of aseptic, purified,~     cryopreserved, vialed Plasmodium falciparum sporozoites.~   "
85295|NCT02450565|"~     Neuropathic pain, described as 'pain arising as a direct consequence of a lesion or disease~     on the somatosensory system', affects up to 3-9.8% of the investigators' population, but is~     often underdiagnosed and undertreated. As treatment is different for patients with~     neuropathic pain and nociceptive pain, it is important to screen for neuropathic pain.~     Commonly employed questionnaire-based diagnostic tools in English speaking countries include~     the Leeds Assessment of Neuropathic Symptoms and Signs pain scale (LANSS) and Neuropathic~     pain questionnaire (NPQ). Self-completed LANSS is particularly useful as it is not restricted~     to clinician's examination and can be applied in large-scale research. S-LANSS has been~     successfully translated, validated and used successfully in Arabic and Turkish, but it has~     not been utilised in the Chinese population. As verbal translations of the English~     questionnaires used at the bedside may be prone to errors in interpretation and requires~     medical practitioners to interpret the questions. Therefore a translation and validation~     study is essential.~   "
85296|NCT02450552|"~     This study evaluates the effect of retigabine (600 mg/day, 900 mg/day, or placebo) on motor~     neuron activity in people with Amyotrophic Lateral Sclerosis (ALS). The total study duration~     is approximately 14 weeks. ALS subjects will take study drug for approximately 10 weeks.~   "
85297|NCT02450539|"~     The main purpose of this study is to evaluate the effectiveness of the study drug known as~     abemaciclib versus docetaxel in participants with stage IV squamous non-small cell lung~     cancer (NSCLC) previously treated with platinum-based chemotherapy.~   "
85298|NCT02450526|"~     The objective of this study is to demonstrate the efficacy of Dysport for the improvement in~     appearance of moderate to severe glabellar lines and to assess the short term and long term~     safety of Dysport, used for the improvement in appearance of moderate to severe glabellar~     lines in Chinese subjects.~   "
85299|NCT02450513|"~     Observational pharmacokinetics study of adalimumab in patients with active refractory Crohn's~     disease who are naïve to TNF antagonist therapy.~   "
85300|NCT02450500|"~     More than a third of the adult population in England have prediabetes, a condition that~     occurs when glucose levels are higher than normal but not high enough to be diagnosed as~     diabetes. Between 5 and 10% of people with prediabetes will go on to develop diabetes each~     year. Lifestyle (diet and activity) interventions have been shown to reduce the risk of~     prediabetes progressing to Type 2 diabetes. However, in practice high levels of professional~     support coupled with increasing incidence of prediabetes are not sustainable in their current~     format. The internet has the potential to provide an alternative means of supporting large~     numbers of individuals in making lifestyle changes. However, provision of information on its~     own is not enough to engage individuals to change - additional support via personalised~     feedback is required to sustain the level of motivation needed for long term behaviour~     change.~      AIM: The investigators hypothesis is that communicating with individuals at high risk of Type~     2 diabetes via a web-based lifestyle app will lead to changes in lifestyle behaviours~     resulting in an improved glycaemic control and reduction in diabetes risk.~      METHOD: The study will be conducted over 6 months. Patients identified in GP practice who are~     at high risk of developing diabetes will be invited to take part in this feasibility study.~      Intervention (6 months): This will consist of a web-based lifestyle app and personalised~     behaviour modification advice delivered via messaging by a dietitian. Participants will also~     be issued with a pedometer. Data on the dietary intake and activity levels will be collected~     on the web-based lifestyle app. Contact between the dietitian and participants will consist~     of weekly messaging to facilitate changes in diet and activity behaviour through motivational~     and cognitive behavioural strategies.~      Blood biochemistry (HbA1c, FBG, LFT's and lipids), BP, weight, BMI, and waist circumference~     will be measured at 0, 3 and 6 months. The blood test will be taken by a practice nurse at~     the GP practices and sent off for analysis. A 5 day food diary, well-being and activity~     questionnaires will be collected at 0, 3 and 6 months by the researcher.~      At the end of the intervention period, participants will be invited to attend a focus group~     to assess participants' perceptions/ease of use and barriers to use of the technology~     employed to assist behaviour change~   "
85301|NCT02450487|"~     Pharmacogenetics is an area of Pharmacology that studies the contribution of genetic factors~     to individual responses to drugs. This branch of science involves the variability in~     pharmacodynamics and pharmacokinetics through the study of polymorphisms in genes encoding~     receptors, as well as in drug metabolism, where this area of Pharmacology has been growing~     and achieving its first results with clinical use. The non-steroidal anti-inflammatory~     (NSAIDS) are metabolized by cytochrome P450 (CYP) family, predominantly CYP2C9. The goal of~     this study is to evaluate the different gene haplotypes for the clinical efficacy of~     piroxicam after third lower molar surgery for pain, edema and trismus, adverse reactions,~     need of rescue medication, patient satisfaction regarding the drug and the pharmacokinetics~     of the drug between the different gene haplotypes for CYP2C9 that are found in this~     population. Therefore, 60 patients will be genotyped and phenotyped for this gene and their~     postoperative data will be confronted with the data found in the Brazilian population. For~     the analysis of the proposed gene, saliva will be collected and serve as a source of genomic~     DNA. For the molecular analysis, polymerase chain reaction (PCR) with tests validated and~     produced by Applied Biosystems® will be performed. For the pharmacokinetics, saliva samples~     will be collected at various times according to protocols available in the literature, and~     piroxicam concentrations in the samples will be measured by high pressure liquid~     chromatography (HPLC) and Liquid chromatography-mass spectrometry (LC MS/MS). The analysis of~     the results will be described with a significance level of 0.05.~   "
85347|NCT02449889|"~     This trial is investigating the efficacy and safety of highly purified human chorionic~     gonadotropin (HP-hCG) and recombinant human chorionic gonadotropin (rhCG) for triggering of~     final follicular maturation in women undergoing controlled ovarian stimulation~   "
85302|NCT02450474|"~     Cardiovascular disease is the leading cause of death of dialysis patients and poor fluid~     management is associated with the increased risk. One of the principal limitations in~     avoiding chronic fluid overload in this patient group is the refilling rate the rate at which~     fluid is transferred from tissues into the vascular system. If this rate cannot match the~     prescribed rate of fluid removal during dialysis the patient will end up with chronic fluid~     overload.~      Two proposed methods of increasing the rate of refilling are intermittent pneumatic~     compression (IPC) devices, which increase the pressure of the fluid in tissue, and~     neuromuscular electrical stimulation (NMES) which activates the muscle pump and lymphatic~     drainage.~      This investigation will trial the use of these two methods in patients suspected of having~     inadequate refilling rates. Outcome measures will be based on fluid status, presence of~     oedema and quality of life.~   "
85303|NCT02450461|"~     The purpose of this study is to answer the question whether a disease-specific profile of~     breath in patients with asthma can be detected by an untargeted metabolomic study using~     exhaled breath analysis by mass spectrometry.~   "
85304|NCT02450448|"~     Circulating tumor cells (CTCs) have the potential to provide a surrogate for'real-time~     biopsy' of tumor biological activity. Enumeration and molecular characterization of CTCs in~     renal cancer could play an important role in diagnosis, predicting the risk for tumor~     recurrence, and providing novel target therapy biomarkers. In view of these facts, the~     investigators wanted to demonstrate the value of multiparameter flow cytometry in detecting~     human tumor cells of renal cancer in normal peripheral blood after cryosurgery with or~     without dendritic cell(DC)-cytokine-induced killers(CIK) treatment, and the investigators~     also compared the specificity with reverse transcriptase polymerase chain reaction (RT-PCR)~     method.~   "
85305|NCT02450435|"~     Circulating tumor cells (CTCs) have the potential to provide a surrogate for'real-time~     biopsy' of tumor biological activity. Enumeration and molecular characterization of CTCs in~     prostatic cancer could play an important role in diagnosis, predicting the risk for tumor~     recurrence, and providing novel target therapy biomarkers. In view of these facts, the~     investigators wanted to demonstrate the value of multiparameter flow cytometry in detecting~     human tumor cells of prostatic cancer in normal peripheral blood after cryosurgery with or~     without dendritic cell(DC)-cytokine-induced killers(CIK) treatment, and the investigators~     also compared the specificity with reverse transcriptase polymerase chain reaction (RT-PCR)~     method.~   "
85306|NCT02450422|"~     Circulating tumor cells (CTCs) have the potential to provide a surrogate for'real-time~     biopsy' of tumor biological activity. Enumeration and molecular characterization of CTCs in~     colorectal cancer could play an important role in diagnosis, predicting the risk for tumor~     recurrence, and providing novel target therapy biomarkers. In view of these facts, the~     investigators wanted to demonstrate the value of multiparameter flow cytometry in detecting~     human tumor cells of colorectal cancer in normal peripheral blood after cryosurgery with or~     without dendritic cell(DC)-cytokine-induced killers(CIK) treatment, and the investigators~     also compared the specificity with reverse transcriptase polymerase chain reaction (RT-PCR)~     method.~   "
85307|NCT02450409|"~     Beside the current standard of classical mechanical alignment of total knee replacements,~     increased interest is being shown in anatomical alignment. However, no surgical technique is~     capable of controlling the stability of the joint in midflexion. The purpose of the present~     study was to present and evaluate a new surgical technique, which aims to reduce the need for~     soft-tissue release and optimize stability in midflexion.~   "
85308|NCT02450396|"~     Rare diseases frequently affect women of childbearing age. Pregnancy in these women has~     become less rare, but remains associated with high levels of complications. One obstacle to~     their optimal management during pregnancy is that there are no prospective studies of~     pregnancy during rare diseases and several connective tissue diseases. As a consequence, the~     management of these pregnancies is non-standardised in terms of treatment, monitoring~     (frequency of consultations, laboratory tests and ultrasound), and organisation of care.~      Moreover, although these women (all diseases combined) are frequently exposed to medications~     potentially incompatible with pregnancy, little is known about the frequency of these~     exposures and especially their consequences to mother and child.~      For these reasons, researchers and clinicians from different specialties created an~     interdisciplinary research group on pregnancy and rare diseases (GR2), intended to improve~     the management of these patients' pregnancies. Using a single computer server, the~     investigators plan to set up a large prospective study of pregnancies in patients with rare~     diseases: various forms of myositis, lupus, antiphospholipid syndrome, Sjogren syndrome,~     scleroderma, and inflammatory rheumatic diseases. The investigators objective is to analyse~     the complications of pregnancies in women with rare diseases and then to improve their~     management and their quality of life.~   "
85309|NCT02450383|"~     The purpose of this non-inferiority trial is to determine the clinical efficacy of acellular~     dermal matrix (ADM) in the augmentation of the gum around dental implants as compared to an~     autologous gum graft (sCTG) obtained from the palate (roof of the mouth) in human adults.~      AlloDerm is regulated by the US Food and Drug Administration (FDA) as human tissue for~     transplantation. AlloDerm is processed and marketed in accordance with the FDA's requirements~     for banked human tissue (21 CFR, Part 1270 and Part 1271) and Standards for Tissue Banking of~     the American Association of Tissue Banks (AATB).~      Twenty adult subjects will be recruited who are in need of dental implant placement with~     simultaneous gum grafting to increase the thickness of the facial mucosa. Half of the~     subjects will be randomized to the ADM group and half will be randomized to the sCTG group.~     The surgical intervention will be performed according to the protocol and subjects will~     return for follow-up 2, 4, 8, and 16 weeks post-surgery for follow-up measurements of~     healing, gum thickness, subject perception of pain, and esthetic photographs.~   "
85348|NCT02449876|"~     This is a pilot study to determine if neuroscience education is acceptable to adults over 65~     and if it can have an impact on pain, pain beliefs and gait speed~   "
85349|NCT02449863|"~     Neonatal respiratory distress prognosis may be difficult to estimate at admission. Lung~     ultrasound is a useful diagnostic tool that is quick, requires little training and is~     radiation free. This study analyzes whether early lung ultrasound can predict respiratory~     failure.~   "
85425|NCT02448875|"~     This study is to assess the safety and effectiveness of the use of visco-assisted CyPass~     Micro-Stent implantation for the lowering of intraocular pressure (IOP) in patients who have~     open angle glaucoma (OAG).~   "
85310|NCT02450370|"~     Subjects with confirmed diagnosis of Irritable Bowel Syndrome will be blinded and randomly~     assigned to one of two groups, the low FODMAP diet or the conventional IBS diet group. They~     will be referred to do three hydrogen breath tests prior to diet education. Upon completion,~     subjects will attend dietitian consultations at Week 0, 6 and 10 for diet assessment,~     education and reinforcement. At Week 4 and 8, dietitians will telephone patients to check on~     diet compliance and answer any diet question. Two sets of questionnaires, the IBS Global~     Improvement Scale and the IBSQOL will be given to patients to complete before each dietitian~     visit at week 0, 6 and 10. Two sample t-test and Chi square test will be used to test the~     difference between the two groups and the association between breath tests results and~     responds to the two diets.~   "
85311|NCT02450357|"~     Circulating tumor cells (CTCs) have the potential to provide a surrogate for'real-time~     biopsy' of tumor biological activity. Enumeration and molecular characterization of CTCs in~     breast cancer could play an important role in diagnosis, predicting the risk for tumor~     recurrence, and providing novel target therapy biomarkers. In view of these facts, the~     investigators wanted to demonstrate the value of multiparameter flow cytometry in detecting~     human tumor cells of breast cancer in normal peripheral blood after cryosurgery with or~     without dendritic cell(DC)-cytokine-induced killers(CIK) treatment, and the investigators~     also compared the specificity with reverse transcriptase polymerase chain reaction (RT-PCR)~     method.~   "
85312|NCT02450344|"~     Objectives The aims of this study are to test the effectiveness of an online quiz competition~     in changing adolescents' alcohol-related attitudes and behaviour and to explore the~     fe¬asibility of using Internet viral marketing to reach a significant number of adolescents.~      Hypotheses to be tested~        1. The present online quiz competition is more effective in changing adolescents'~          alcohol-related attitudes and behaviours than traditional health promotion.~        2. Internet viral marketing is effective in reaching a significant number of adolescents.~      Design and subjects The study will constitute a cluster randomised controlled trial for 20~     secondary schools (6,720 Grade 7 to 9 students). Schools will be randomised to intervention~     or control arm with equal likelihood. Students in intervention schools will be invited to~     take part in the Internet campaign whereas those in control schools will receive relevant~     promotional leaflets.~      Study instrument An alcohol attitude and behaviour survey will be compiled with reference to~     standardised, validated instruments.~      Intervention Participants will log into the website and answer alcohol-related~     multiple-choice questions. They will be encouraged to promulgate the campaign to others.~      Main outcome measures Alcohol-related attitude and behaviour will be the primary outcome~     measures.~      Data analysis Multilevel regressions will mainly be used to evaluate the difference in~     attitude and behaviour.~      Expected results The results of the proposed study will provide evidence on the efficacy of~     an Internet intervention in modifying adolescents' attitudes and behaviour and guide further~     investigation into the prevention of and intervention in such risk behaviours as underage~     drinking.~   "
85313|NCT02450331|"~     This Phase III, open-label, randomized, multicenter study is to evaluate the efficacy and~     safety of adjuvant treatment with atezolizumab compared with observation in participants with~     muscle-invasive UC who are at high risk for recurrence following resection. Eligible~     participants will be randomized by a 1:1 ratio into atezolizumab group or control group.~   "
85314|NCT02450318|"~     The purpose of this study is to examine the acute effect of exercise on vascular function in~     women with nonobstructive coronary artery disease.~   "
85315|NCT02450305|"~     The investigators intend to determine if patients that are already undergoing Hyperbaric~     Oxygen (HBO) therapy one year post treatment with radiation therapy for head and neck cancer,~     experience improvement in xerostomia and/or taste alteration. The investigators will enroll a~     similar demographic one year post treatment with radiation therapy that does not receive HBO~     therapy. This is a quality of life study.~   "
85316|NCT02450292|"~     The purpose of this study is to examine the long-term appearance and resorption rate of~     biocomposite screws used during ACL reconstruction on X-ray and computed tomography (CT).~   "
85317|NCT02450279|"~     Many devices are available for nebulising drug solution during invasive mechanical~     ventilation. Vibrating-mesh nebulizers ensure the highest lung deposition output. A recent~     international survey on aerosol therapy during mechanical ventilation (Ehrmann et al. 2013)~     reported that jet nebulizers remained the mostly used.~      The aim of this study is to compare lung deposition of a radiolabeled administered with both~     nebulizers during invasive mechanical ventilation by planar scintigraphy.~   "
85318|NCT02450266|"~     Patients will be submitted to a multiparametric MRI examination of the prostate.~     Subsequently, all participants will be randomized (1:1) into both study arms. In study arm A~     patients will be submitted to the gold-standard which comprises systematic transrectal~     ultrasound-guided prostate biopsy. In study arm B patients will be submitted to targeted~     prostate biopsy based on the multiparametric MRI findings.~   "
85319|NCT02450253|"~     Could Tadalafil improve blood flow in deep brain tissue and potentially improve cognitive~     function in patients with cerebral small vessel disease~   "
85320|NCT02450240|"~     In this study the investigators will seek to improve our understanding of how positive and~     negative valence systems, cognition, and arousal/interoception are inter-related in disorders~     of mood, substance use, and eating behavior. The investigators will recruit 1000 individuals~     and use a wide range of assessment tools, neuroimaging measures, blood and microbiome~     collections and behavioral tasks to complete the baseline and follow-up study visits. Upon~     completion, the investigators aim to have robust and reliable dimensional measures that~     quantify these systems and a set of assessments that should be recommended as a clinical tool~     to enhance outcome prediction for the clinician and assist in determining who will likely~     benefit from what type of intervention.~   "
85321|NCT02450227|"~     Absorption and metabolism of carotenoids from two types of spinach preparations will be~     investigated in two study groups, short bowel/ileostomy and healthy, respectively.~      The study will be conducted as a randomised, controlled, 2-way crossover study in 24~     participants (12 in each group), randomized to two sequences (1-2, 2-1) of interventions with~     a more and a less bio-accessible spinach preparation. The serum, chylomicron and~     fecal/effluent levels of lutein and beta-carotene will be determined.~   "
85323|NCT02450201|"~     This is a pilot clinical study of hyperpolarized pyruvate (13C) injection that includes the~     acquisition of magnetic resonance (MR) data and will be performed in men with localized~     prostate cancer. Part 1: Five patients will be evaluated for reproducibility of 13C HP MR~     imaging measurements obtained 2-3 weeks apart with no interim treatment. Part 2: Five~     patients will be evaluated for the change in 13C HP MR imaging measurements after 2 months of~     ADT.~      13C HP MR data will be acquired in two parts of the study (which can occur simultaneously):~     Part 1: Patients will undergo imaging at baseline and will be repeated two to three weeks~     later (with no intervention in the interim) to evaluate reproducibility.~      Part 2: Patients will undergo imaging at baseline, initiate androgen deprivation therapy, and~     undergo repeat imaging two months after initiation of ADT to evaluate the ability of the~     imaging to reflect a metabolic response to treatment.~      The change in pyruvate/lactate ratio and lactate levels will be measured and compared to~     baseline at these timepoints.~   "
85324|NCT02450188|"~     The aim of the present study is to evaluate the efficacy of a combined approach with~     Vardenafil orodispersible and Cognitive Behavioural Sex Therapy in the treatment of Erectile~     Dysfunction, compared to medical only treatment, in terms of quality and duration of erection~     and couple's sexual satisfaction.~   "
85325|NCT02450175|"~     The purpose of this research study is to understand if platelets in the blood become more~     active during cancer and specially advanced stages of cancer, in the future the investigators~     want to see if reducing platelet activity can improve survival in advanced cancer.~   "
85326|NCT02450162|"~     -  Background and study aims : The investigators conducted this study to compare the~          movement of extraocular muscle after two types of recession surgery with non-invasive~          tool called AS-OCT.~        -  Who can participate? patients who will undergo two types (conventional method and~          hang-back method) of typical bilateral lateral rectus recession surgery for correcting~          intermittent exotropia~        -  What does the study involve? Volunteers will attend a clinic for four visits over three~          months. They will undergo AS-OCT at every visits during follow up period. AS-OCT is~          non-invasive test to evaluate operation site. The test only requires their cooperation~          when they undergo AS-OCT.~        -  What are the possible benefits and risks of participating? This is non-invasive test for~          your postoperative follow up. Therefore, there will be no risks about this test.~        -  Where is the study run from? Samsung Medical Center~        -  When is the study starting and how long is it expected to run for? From April 2015 to~          Dec 2015~   "
85327|NCT02450149|"~     This is a pilot study of sorafenib in patients with BRAF Mutation Refractory Solid Tumors.~      This study is a single-arm, pilot study of sorafenib in patients with Refractory Solid Tumors~     harboring BRAF Mutation Sorafenib 400 mg will be administered orally twice a day for 28 days.~      To investigate the efficacy of sorafenib in patients with Refractory Solid Tumors harboring~     BRAF Mutation.~   "
85328|NCT02450136|"~     This is a pilot study of Pazopanib in patients with FGFR2 Amplification or FGFR2 mutation~     Refractory solid tumors.~      This study is a single-arm, pilot study of Pazopanib in subjects with Refractory solid tumors~     harboring FGFR2 Amplification or FGFR2 mutation Pazopanib 800mg will be administered orally~     once a day 28 days.Study treatment will be continued until objective disease progression.~      To investigate the efficacy of Pazopanib in subjects with Refractory solid tumors harboring~     FGFR2 Amplification or FGFR2 mutation.~   "
85329|NCT02450123|"~     This is a pilot study of sunitinib in patients with RET fusion positive or FGFR2~     Amplification Refractory solid tumors.~      This study is a single-arm, pilot study of sunitinib in subjects with Refractory solid tumors~     harboring RET fusion positive or FGFR2 Amplification sunitinib 50mg will be administered~     orally once a day 42 days.Study treatment will be continued until objective disease~     progression.~      To investigate the efficacy of sunitinib in subjects with Refractory solid tumors harboring~     RET fusion positive or FGFR2 Amplification.~   "
85330|NCT02450110|"~     A randomized pilot study of spinal cord stimulation in patients with chronic heart failure~     aiming to show whether this therapy impacts central haemodynamic and autonomic regulations.~   "
85331|NCT02450097|"~     The aim of the present study is to investigate in subjects with and without type 2 diabetes~     the effect of calorie restriction (CR) according to the 5:2 method for 6 months (every week~     two days caloric fasting with 500 calories for women and 600 calories for men and five days~     of normal caloric intake) on risk markers for cardiovascular disease and certain cancers~     (hyperinsulinemia, insulin resistance, IGF-1, IGFBP-1, IGFBP-2, glucose, HbA1c, blood lipids,~     markers of inflammation and oxidative stress) and on peptides regulating glucose metabolism~     and appetite as well as the effect on blood pressure, body composition, waist- and hip-~     circumference. DNA will also be analysed at the start and after 6 months to investigate any~     epigenetic effects.~      After completed study there will be a follow up after additional 6 months.~   "
85332|NCT02450084|"~     Rectus sheath block (RSB) is a kind of anterior abdominal wall block. It has postoperative~     analgesic effect for abdominal surgery with midline incision. Robotic gynecologic surgery is~     accompanied by significant postoperative pain and usually IV-PCA is used to manage the~     pain.The purpose of this study is to investigate the analgesic effect of ultrasound-guided~     RSB to single-port robotic gynecologic surgery which has incision site at umbilical area.~     Patients will randomly assigned to two groups, RSB group and Control group. Each patients~     will assessed for time to first rescue analgesia, verbal numerical rating pain scores, number~     of rescue analgesic demands, and postoperatively opioids use by IV-PCA by a blinded~     investigator at 0, 1, 6, 12, 24 and 48 hours postoperatively.~   "
85361|NCT02449707|"~     Ultrasound activated pins have been used for the promotion of bone healing in combination~     with biodegradable membranes during bone grafting procedures. In the jaws, these pins have~     been successfully tested for both maxillary and mandibular ridge augmentaton. However, the~     usefulness of these pins in maxillary sinus lift procedures has not been tested. This study~     aims to use a bilateral split mouth design to compare the bone formation, healing and~     post-operative complications after the use of ultrasonic guided pins in a lateral window~     maxillary sinus augmentation procedure in comparison to lateral window maxillary sinus~     augmentation procedure procedure performed without the use of these pins.~   "
85362|NCT02449694|"~     A prospective, single-center controlled trial to evaluate the safety and performance of the~     portable Organ Care System (OCS) Liver for preservation and assessment of donor livers for~     transplantation.~   "
85333|NCT02450071|"~     Pre-Hospital Advanced Airway Management (PHAAM) is a potentially lifesaving intervention. A~     recent Danish multicentre single country study demonstrated a 99,7% incidence of successful~     anaesthesiologist pre-hospital endotracheal intubation, with a PHAAM-related complication~     rate of 7.9%. A London study revealed a significantly higher intubation failure rate among~     non-anaesthesiologist physicians. In Scandinavia different types of emergency medical~     services (EMS) and professions provide PHAAM. The success rate of prehospital endotracheal~     intubation (PHETI), incidence of difficult intubation and complications in the Nordic~     countries is not known. The aim of this study is to define PHAAM success rate and~     complications in different types of Nordic EMS organisations and physician critical care~     teams. The study is a prospective observational study with collection of PHAAM data according~     to the template by Sollid et al. in the 12 participating Nordic Countries EMS/HEMS centres~     and physician critical care teams. The primary endpoint is PHETI success on ≤2 attempts and~     no complications.~   "
85334|NCT02450058|"~     In this multicenter, randomized phase III trial, node positive early breast cancer patients~     are randomly assigned to receive either 6 cycles of FEC (5-fluorouracil 600 mg/m2, epirubicin~     60 mg/m2 and cyclophosphamide 600 mg/m2, on day 1, every three weeks) or 4 cycles of EP~     (epirubicin 90 mg/m2 and paclitaxel 175 mg/m2, on day 1, every three weeks). The primary~     study endpoint is overall survival (OS). Secondary endpoints include toxicity and event free~     survival (EFS).~   "
85335|NCT02450045|"~     Hip fractures (broken hips) are common in older people, particularly older women with fragile~     bones, and usually occur with a simple fall from a standing height. In Canada, over 28,000~     hip fractures occur every year, and approximately 900 occur in Edmonton. After a hip~     fracture, up to 50% of those who survive their hip fracture do not recover to the same level~     of activity that they had before breaking their hip. Managing pain with any broken bone is~     very important. For patients with hip fracture, their older age and fragile health makes pain~     management even more challenging. Many patients with a hip fracture have reduced ability to~     think clearly before the fracture. Some patients who have no difficulty with thinking before~     their hip fracture will become confused for a brief period after their hip fracture or can~     develop permanent difficulties with thinking. A hip fracture will usually require an~     operation, and choosing the right pain medication before and after the operation is important~     since many pain medications make confusion more likely. Permanent difficulty with thinking is~     a common reason for poor recovery after hip fracture. Our study will look at use of a nerve~     block to manage pain before patients have their operation. A nerve block provides local pain~     relief without requiring patients to take the medication by mouth (oral) or through an~     intravenous (IV) route. A nerve block before surgery may reduce the amount of oral and IV~     pain medication needed by the patient both before and after their operation but still provide~     good pain control with less confusion. This could lead to better recovery and allow more~     patients to return to living in the community rather than long-term care.~   "
85336|NCT02450032|"~     This study was designed to investigate the antibody response generated by a 500µg dose of~     G17DT in patients with gastric cancer.~   "
85337|NCT02450019|"~     The purpose of this study is to assess the effect size and variability of dural tension~     measured as intracranial pressure (ICP) below the dura of the surgical field in patients~     undergoing elective supra-tentorial surgery for brain neoplasms in patients alternatively~     ventilated with traditional high-volume-no-PEEP ventilation and protective~     low-volume-low-PEEP ventilation.~   "
85338|NCT02450006|"~     To collect biological samples, clinical information and laboratory data from patients~     diagnosed with any healthcare-related conditions who are seen at facilities affiliated with~     Intermountain Healthcare, including patients and their family members, and to collect the~     same information and samples from a general population including disease-free subjects.~   "
85339|NCT02449993|"~     This is a prospective examination of ribonucleic acid (RNA) extracted from tumor material of~     breast cancer patients treated with a neo-adjuvant therapy. The RNA will be analysed for~     expression of estrogen receptor (ER 1), progesterone receptor (PgR), HER2 and Ki-67 with~     MammaTyper™.~      According to the determined values for the individual parameters at least 4 subtypes can be~     distinguished to date~        -  Luminal A-type~        -  Luminal B-type~        -  HER2-type~        -  Triple-negative-type As non-clinical endpoint, the agreement of new subtyping with~          Immunohistochemical methods will be evaluated.~      As clinical objective, the 5 year Distant metastasis free survival (DMFS) and Overall~     survival (OS) will be reevaluated according to the new subtyping.~   "
85340|NCT02449980|"~     The purpose of this study is to compare the effectiveness of two treatment~     strategies--delayed versus immediate surgery-- for children with primary spontaneous~     pneumothorax (collapse of the lung). Currently, both treatment modalities are used and there~     is no clear evidence that either option is superior. The investigators hypothesize that~     immediate surgery will have better outcomes with lower recurrence rates than delayed surgery.~   "
85341|NCT02449967|"~     The purpose of this study is to evaluate the safety and efficacy of HepaSphere interventional~     therapy using digital subtraction Angiography（DSA）for pancreatic cancer.~   "
85342|NCT02449954|"~     Comparison between the effects of intravenous morphine, tramadol and ketorolac on stress and~     immune responses in patients undergoing modified radical mastectomy~   "
85343|NCT02449941|"~     The purpose of this study is to know the distribution of HP in stomach before use of PPI,~     during use of PPI, and after stop of PPI.~   "
85344|NCT02449928|"~     Using sodium lactate Ringer's injection resuscitate septic shock patients and Compared with~     other solution, in order to make clear whether can improve the prognosis.~   "
85345|NCT02449915|"~     To determine if the injection of liposomal bupivacaine to laparoscopic port sites and~     rectocele repair incisions at the completion of a robotic sacrocolpopexy with concomitant~     rectocele repair will result in decreased postoperative pain compared to injection of~     placebo.~   "
85346|NCT02449902|"~     The study was designed to evaluate the efficacy and safety of TX-12-004-HR 10 μg in treating~     moderate to severe symptoms of vaginal atrophy associated with menopause after 14 days of~     treatment, and to estimate the effect size and variability of vulvovaginal atrophy endpoints.~     In addition, the systemic exposure to estradiol from single and multiple doses of~     TX-12-004-HR was to be investigated.~   "
85350|NCT02449850|"~     The primary objective is of the PreventADALL study is to test if primary prevention of~     allergic diseases is possible by simple and low cost strategies, and secondary to asses the~     impact of xenobiotic exposure and microbiota in and on the body and the environment on~     allergic disease development.~      The secondary objective is an exploratory focus to investigate early life risk factors for~     development of non-communicable diseases, including asthma and allergic diseases as well as~     for diseases that may share common risk factors, including cardiovascular disease, obesity~     and diabetes.~      Design: A multi-national population-based prospective birth cohort with a factorial designed~     randomized controlled intervention trial of two clinical interventions; skin care 0-9 months~     and early food introduction by 3-4 months, thereafter observation only.~      Recruitment in three cities (Oslo, Ostfold and Stockholm) of approximately 2500 mother-child~     pairs is done in two steps; first pregnant women are recruited and enrolled at the 18-weeks~     ultrasound investigation (n=approximately 2700) and thereafter their new-born babies are~     included.~      Randomization into four groups is done by the postal code or township to ensure all four~     intervention-groups within each township.~      Visits for biological and environmental sampling, observations and investigations will be at~     the relevant pediatric departments (at 3-6-12-24-36 months of age) and through childhood into~     adulthood thereafter, provided sufficient funding.~   "
85351|NCT02449837|"~     The purpose of this study is to investigate the level of Circulating Tumor Cells (CTCs) in~     cancer patients before and after undergoing treatment regimens where the primary treatment~     modality is radiation therapy (XRT). Specifically, there is interest in the change in CTCs~     pre- and post- XRT, both in absolute and relative terms.~   "
85352|NCT02449824|"~     Firstly, the investigators aim to show that breast tumour blood flow, measured as part of a~     standard MRI examination, decreases at the earliest stage of neoadjuvant chemotherapy in~     those patients who go on to respond to treatment. Importantly, the investigators will also~     show that blood flow does not decrease in those patients who fail to respond.~      Secondly, the investigators will test whether the decrease in tumour blood flow over the~     whole course of neoadjuvant chemotherapy can predict the response of the tumour measured at~     the time of surgery.~   "
85353|NCT02449811|"~     Randomized, open-label, parallel-group study conducted at a single center in Switzerland.~      Patients diagnosed with primary arterial hypertension requiring antihypertensive drug~     Treatment as well as patients after a 4 week wash out period (Amendment 07/2016) will be~     recruited at the University Hospital Basel, Switzerland. Subjects will be randomized to~     either the angiotensin-converting enzyme inhibitor-, angiotensin receptor blocker-, calcium~     channel blocker- or hydrochlorothiazide-treatment arm. Drug treatment follows current~     guidelines issued by the European Society of Hypertension. Treatment-naive patients will be~     started on an intermediate dose monotherapy (treatment period 1). In all patients who do not~     reach blood pressure targets after 4 weeks, the dose of the monotherapy drug will be doubled~     (high dose, treatment period 2). Sampling for the analysis of RAS peptide profiles,~     measurement of drug concentrations in plasma and non-invasive hemodynamic measurements will~     be done. A control group with 20 age and gender matched, healthy and normotensive subjects~     will be recruited to establish the characteristics of the RAS peptide profiles in a~     comparable but normotensive population.~   "
85354|NCT02449798|"~     Study objective is to evaluate user preference, time for procedure, insertion success rates,~     complications, completion of therapy and dwell time of the AccuCath 2.25 BC device placed in~     difficult IV access patients in the emergency department.~   "
85355|NCT02449785|"~     Non-invasive assessment of lung involvement is a crucial issue for the follow-up of cystic~     fibrosis patients. Currently, CT is the method of reference to evaluate and quantify the lung~     morphological changes in cystic fibrosis adults but it remains a radiation-based technique.~     MRI with ultrashort echo time (UTE) pulse sequences is a promising non-ionizing alternative~     for lung imaging. The investigators' objective is to evaluate cystic fibrosis lung~     involvement using CT and MRI-UTE, and to test the agreement between both techniques.~   "
85356|NCT02449772|"~     Retrospective study of adult patients (> 16 y) admitted to Geneva University Hospitals with~     alcohol abuse. Triage criteria will be reviewed. Patients characteristics and patient flow in~     the ED will be described.~   "
85357|NCT02449759|"~     This study aims to evaluate the effectiveness of a guided self-help intervention using~     Acceptance and Commitment Therapy (ACT). Half of the participants will receive the self-help~     manual whilst on a waiting list for individual therapy, while the other half will remain on a~     waiting list and not receive the manual. This study is looking specifically at individuals~     with mild to moderate anxiety and/or depression.~   "
85358|NCT02449746|"~     Psychosis is a mental health problem that causes people to perceive or interpret things~     differently from those around them, often involving hallucinations or delusions. Psychosis~     and schizophrenia are common disorders which predominantly affect younger adults. Recently,~     the investigators discovered that 5-10% of people with psychosis have antibodies in the blood~     that are capable of targeting the surface of brain cells, specific to the~     N-methyl-D-aspartate (NMDA) receptor or voltage gated potassium channel complex, which the~     investigators believe may be causing the problem. Those positive for antibodies may have a~     problem with their immune system and this may prevent their brain from working normally. This~     trial aims to test the feasibility of removing or reducing the antibodies in patients' blood,~     using immunotherapy, and see if this improves symptoms of psychosis. Immunotherapy in this~     feasibility study will involve giving all patients steroid tablets and half of them will also~     receive a drug called intravenous immunoglobulin whereas the other half will have a~     procedure called plasma exchange. The feasibility study is designed to identify which~     method of immunotherapy is most suitable for use in this patient population.~      Results from this will inform on the methodology used for a proposed larger randomised~     control trial.~   "
85359|NCT02449733|"~     The purpose of this study is to evaluate the acceptability and uptake of a combination~     package of biomedical, behavioral and community-level HIV prevention interventions and~     services for men who have sex with men (MSM) in South Africa.~   "
85360|NCT02449720|"~     This study will evaluate the addition of a local anaesthetic infusion into the abdomen to~     patient controlled analgesia in the management of postoperative pain and recovery after bowel~     surgery. Half of the patients will have an infusion of a local anaesthetic called ropivacaine~     and half will have an infusion of placebo in addition to their normal pain relief.~   "
85364|NCT02449668|"~     The main objective of the current study was to assess the analgesic effect achieved to short-~     and medium-term by the use of acupuncture on individuals with impingement syndrome of the~     shoulder, in comparison to the use of acupuncture at sham points. Furthermore, secondary~     objectives were also sought, such as the short- to medium-term functional recovery of the~     affected joint, knowing the possible influence that this has over the recovery of the~     laterality of the subject, as well as the development of a protocol to select points to treat~     pain affecting the shoulder area.~   "
85365|NCT02449655|"~     Phase II trial of AZD5363 plus paclitaxel / AZD2014 plus paclitaxel in biomarker negative~     (PIK3CA/MEK/RAS/TP53/MET) advanced gastric adenocarcinoma patients as second-line~     chemotherapy.~      Each arm is composed of 25 patients.~      AZD5363 400mg bid 4 days on/ 3 days off of a 7 day cycle for each week that paclitaxel is~     given + paclitaxel 80mg/m2 given days 1, 8 and 15 of a 28 day cycle. AZD5363 and paclitaxel~     will be received for 3 consecutive weeks, followed by one week off-therapy in 4-week~     cycles.If paclitaxel therapy is stopped then AZD5363 can be given on a 4on/3off continuous~     schedule.~      AZD2014 50mg BD 3 days on 4 days off of a 7 day cycle + paclitaxel 80mg/m2 given days 1, 8~     and 15 of a 28 day cycle.~      Tumour evaluation using Response Evaluation Criteria in Solid Tumors 1.1 will be conducted at~     screening (within 28 days prior to first dose) and every 8 weeks relative to the date of~     first dose, up to week 40, then every 16 weeks until objective disease progression (within a~     window of +/- 7 days of the scheduled date).~      Study treatment will be continued until objective disease progression.~      The purpose of this study is to investigate the safety and efficacy of AZD5363 plus~     paclitaxel in biomarker negative (PIK3CA/MEK/RAS/TP53/MET) advanced gastric adenocarcinoma~     patients as second-line chemotherapy.~   "
85366|NCT02449642|"~     Monitoring the LH pulsatility during the Luteal phase in GnRH antagonist IVF cycles triggered~     by GnRH agonist for final oocyte maturation.~   "
85367|NCT02449629|"~     This study uses a transformative multiphasic mixed-methods research design that incorporates~     elements of the following designs:~        -  Sequential: a secondary data analysis was conducted, using data from ATN 039, ATN 086,~          and ATN 106, to influence the development of the qualitative interview and quantitative~          survey instruments for primary data collection.~        -  Convergent parallel: concurrent collection and analysis of both qualitative and~          quantitative primary data that will be combined to address the study objectives.~   "
85368|NCT02449616|"~     The purpose of this study is to evaluate the safety of repeat administration of MST-188~     during vaso-occlusive crisis of sickle cell disease. Additionally, this study will evaluate~     the development of acute chest syndrome during VOC and re-hospitalization for recurrence of~     VOC.~   "
85369|NCT02449603|"~     This is a multi-centre, open-label, randomized, parallel trial to compare the effect of~     Exenatide versus Biphasic insulin Aspart 30 on glucose variability and inflammatory markers~     in type 2 diabetes mellitus (T2DM) patients inadequately controlled with metformin~     monotherapy.~   "
85370|NCT02449590|"~     AIMS:~      The aims are to investigate whether:~        -  Increased intake of onion (powder) affects plasma lipid profile, blood pressure, indices~          of insulin sensitivity and blood coagulation.~        -  Increased intake of onion (powder) affects the expression/activity of enzymes in the~          defence against foreign substances, e.g. reactive oxygen species, and whether~          polymorphisms in some of the involved genes may modulate the effect.~        -  Polymorphisms involved in the metabolism/effect of bioactive components in onion~          modulate the excretion of metabolites or modulate some of the outcome variables in the~          study.~      Other aims are to try to identify biomarkers for onion consumption in plasma, urine and feces~     and to investigate whether onion affects the secretion of fat and bile acids.~      HYPOTHESES:~      The investigators hypothesize that:~        -  2 weeks of increased onion intake will improve the plasma lipid profile~        -  2 weeks of increased onion intake will increase the metabolism of potentially harmful~          substances (such as ROS and free radicals) through a change in the expression or~          activity of certain enzymes.~        -  That these effects are modulated by common gene variants (polymorphisms)~   "
85371|NCT02449577|"~     The objective of the study is to identify biomarkers for acute intake of beer and alcohol in~     individuals with a high or low habitual intake. Furthermore, we wish to identify compounds~     and metabolites in different types of beer and alcohol, which can serve as compliance markers~     for intake under the test conditions (blood tests and urine samples). We also wish to~     determine the acute effects of these beverages on plasma glucose and insulin response,~     compared to regular soda.~   "
85372|NCT02449564|"~     This study is a single-arm, phase II study of sirolimus in patient with PIK3CA mutation and~     PIK3CA amplication Refractory solid tumors.~      sirolimus 1mg will be administered orally qd daily.~      To investigate the efficacy of sirolimus in patients with PIK3CA mutation and PIK3CA~     amplication Refractory solid tumors.~   "
85373|NCT02449551|"~     Volitinib is a potent and selective small molecule c-Met kinase inhibitor. Volitinib was~     found to inhibit c-Met kinase at the enzyme and cell levels with IC50s of 4 nM for both~     enzyme and Met phosphorylation in the cell. Consistent with its potent enzyme and cell~     activity, volitinib was found to inhibit cell growth in vitro against tumors with c-Met gene~     amplification in the absence of HGF stimulation with IC50s generally below 10 nM. It also~     potently inhibited HGF-stimulated cell proliferation against tumors with c-Met overexpression~     or carrying a HGF/c-Met autocrine loop.~      This study is a single-arm, phase II study of votilinib in patients with advanced gastric~     adenocarcinoma harboring MET amplification as a third line treatment Volitinib 800 mg will be~     administered orally once a day for 21 days as one cycle.~      To investigate the efficacy of volitinib in patients with advanced gastric adenocarcinoma~     harboring MET amplification.~   "
85374|NCT02449538|"~     This study is a single-arm, phase II study of everolimus in patients with PTEN loss ,PIK3CA~     mutation and PIK3CA amplification Refractory Solid Tumors .~      Everolimus 10 mg will be administered orally qd daily.~      To investigate the efficacy and safety of everolimus in patients with PTEN loss ,PIK3CA~     mutantion and PIK3CA amplification Refractory Solid Tumors.~   "
85413|NCT02449031|"~     This is a multicenter, prospective, two cohort, observational study over a 5-year period in~     Cystic Fibrosis (CF) patients with chronic Pseudomonas aeruginosa infection.The study will~     collect data over 1 year on respiratory function, antibacterial effectiveness, and clinical~     outcomes of treatment with inhaled antipseudomonal antibiotics and data over 5 years on~     microbiological and safety assessments.~   "
85375|NCT02449525|"~     The perfusion of microvascular free flaps is inevitable for completion of reconstruction in~     the head and neck area. In some patients microvascular anastomosis is impossible because of~     arteriosclerotic changes, different oncological interventions, and consecutive vessel~     depletion at the neck. The aim of the project is to establish an innovative system for~     extracorporeal perfusion of microvascular free flaps after ingrowth of new vessels from the~     wound bed have taken place. Afterwards, no further perfusion of the vascular pedicle is~     required for free flaps to survive and provide functional and aesthetic reconstruction.~   "
85376|NCT02449512|"~     Spinal cord injury and other systemic neurological diseases (Multiple Sclerosis, Parkinson's~     disease) affect the integrity of lower urinary tract (LUT) function, leading to neurogenic~     lower urinary tract dysfunction (NLUTD). The urodynamic investigation is the current~     gold-standard for evaluating LUT function. Nevertheless, the sensory situation of the LUT~     cannot be investigated objectively. Furthermore, the current classification of the severity~     of the NLUTD due to spinal cord injury (SCI) does not represent the sensory situation of the~     LUT. Additional investigations therefore need to be established for assessing the sensory~     situation of the LUT. Somatosensory evoked potentials (SEPs) are an established method for~     investigating the processing of sensory nervous activity. However, SEPs from the LUT of SCI~     individuals have not yet been investigated.~      A novel technique, i.e. diffusion tensor imaging (DTI), allows to process magnetic resonance~     images (MRI) in order to visualize nerve fibers. Using DTI, the innervation of the bladder~     after SCI can be visualized. The structural presentation of bladder innervation will be~     compared with the functional results, i.e. the SEP of the LUT in SCI individuals.~      The primary objective of the proposed study is to elicit and characterize (latency,~     amplitude) the somatosensory evoked potentials (SEPs) from the bladder in individuals~     suffering from neurogenic lower urinary tract dysfunction as a result of spinal cord injury.~      Furthermore, the SEPs from the bladder will be compared with the SEPs from peripheral nerves~     (N. tibialis, N. pudendus, N. medianus).~      Moreover, the latency and amplitude of the SEPs from the bladder of individuals with~     somato-sensory complete spinal cord injury will be compared with those from the bladder of~     individuals with somato-sensory incomplete spinal cord injury.~      Finally, the structural innervation of the bladder after SCI will be compared with the~     remaining sensory function.~   "
85377|NCT02449499|"~     Depression and anxiety disorders, even when treated according to standard of care consisting~     of individual treatment with medication and/or therapy, can be associated with significant~     residual impact on quality of life. The purpose of this research is carry out an~     observational study of an existing clinical treatment, adjunctive interpersonally focused~     psychodynamic group therapy, to determine if this can improve quality of life for patients~     who have residual symptoms of chronic depression and anxiety.~   "
85378|NCT02449486|"~     Continuous ropivacaine infusion to sternotomy wound after coronary artery bypass grafting~     (CABG) or heart valve surgery to diminish postoperative pain.~   "
85379|NCT02449473|"~     A Multicentre, Randomized, Double-blind, Parallel Group, Placebo Controlled, 12-Week, Phase 2~     Study to Evaluate the Effect of Tralokinumab on Airway Inflammation in Adults with Asthma~     Inadequately Controlled on Inhaled Corticosteroid.~   "
85380|NCT02449460|"~     The study addresses epidemiology of cardiovascular risk factors and major cardiovascular~     diseases in Russian Federation (urban and rural population). 12 regions of 1600 participants~     in each will be included.~   "
85381|NCT02449447|"~     To asses the clinical effectiveness of blended cognitive behavior therapy (CBT): face-to-face~     and internet-based treatment for adults with Major Depressive Disorder (MDD) in primary care~     compared to treatment as usual.~   "
85382|NCT02449434|"~     This is a questionnaire based study investigating the relationship between the timing of~     dietary acid intake toothbrushing and erosive tooth wear. Data will be collected on the~     timing, nature, frequency and duration of dietary acid intakes and timing and frequency of~     the participants toothbrushing. Signs of the participants erosive tooth wear will then be~     recorded~   "
85383|NCT02449421|"~     The purpose of the study is to compare the impact of two strategies to sustain and improve~     the delivery of an evidence-based psychotherapy for PTSD, Cognitive Processing Therapy (CPT)~     in three different mental health systems. These approaches are based on two different~     theories of what is necessary to promote successful implementation. We will examine whether~     these strategies lead to improved patient outcomes, clinician skill, proportion of clients~     who receive CPT, and other outcomes that are relevant to the implementation of evidence-based~     psychosocial treatments. By examining these questions in 3 different mental health systems,~     we will also examine whether the implementation strategies yield different results in~     different systems.~   "
85384|NCT02449408|"~     The purpose of this study is to evaluate the accuracy of a new device that may be used for~     the evaluation and management of malnourished infants and children. The device will measure~     the levels of two hormones made by fat tissue: leptin and adiponectin.~   "
85385|NCT02449395|"~     This study is designed to collect data on precipitating factors, diagnosis, morbidity,~     therapy, quality of life, and symptom severity, etc. informations in patients with~     fibromyalgia.~   "
85386|NCT02449382|"~     The patients with severe hypernatremia who received conventional treatment are often~     undertreated. Continuous venovenous hemofiltration (CVVH) can effectively remove solute or~     water from circulation system. Several case reports demonstrated that CVVH could effectively~     decrease serum sodium concentration of the patients with severe hypernatremia. The use of~     CVVH for acute severe hypernatremia in critically ill patients could improve patient survival~     by effectively decreasing the serum sodium concentration to a normal level.~   "
85387|NCT02449369|"~     This is a prospective, three-arm, randomized, open-label trial to determine if a new pain~     control protocol which includes regular dosing of intravenous acetaminophen and orphenadrine~     for 48 hours after total knee surgery reduces the need for opioid pain medication and reduces~     average pain scores.~   "
85388|NCT02449356|"~     In this study, the investigators adopt the special endotracheal tube to those patients at~     prone posture during the operation,or those with acute respiratory distress syndrome in the~     intensive care unit(ICU), so that the investigators can reduce, or even avoid some severe~     complications during perianesthesia, and that the investigators can provide strong safeguard~     measures for the respiratory therapy of critical patients in ICU.~   "
85389|NCT02449343|"~     Compare the effects and safety of Anlotinib with placebo in patients with soft tissue~     sarcoma.~   "
85390|NCT02449330|"~     This is the clinical trial designed to assess the cardiac diastolic function of long term~     treatment with teneligliptin compared to that without teneligliptin in patients with type 2~     diabetes mellitus by two arms; one includes patients showing E/e' by echocardiography less~     than 8, the other includes patients showing E/e' by echocardiography more than 8.~   "
85391|NCT02449317|"~     Bioelectrical impedance analysis guided volume expansion for the prevention of contrast~     induced-acute kidney injury~   "
85392|NCT02449304|"~     All women presenting to the gynaecology outpatient clinic with heavy menstrual bleeding (HMB)~     in the absence of recognizable pelvic pathology, as determined by one or all of a normal~     pelvic ultrasound, hysteroscopy and / or endometrial biopsy, refractory to medical therapy~     that persists despite treatment with recommended pharmacological agents(1,2), who have no~     desire to preserve their fertility and are willing to have an endometrial ablation will be~     invited to participate. Eligible women with HMB will undergo radiofrequency G4 endometrial~     ablation in either an inpatient or outpatient setting according to their preference.~      Outcomes will be assessed by administering postal questionnaires to measure menstrual~     bleeding symptoms including rates of amenorrhoea, dysmenorrhoea and life quality at baseline~     and at 6, and 12 months after ablative treatment. After the main study, there will be an~     additional evaluation of the long-term effects of outpatient ablative treatments of the~     endometrium by postal survey at 5 years.~   "
85393|NCT02449291|"~     Double-blind, randomised, parallel-group, placebo-controlled, adaptive, seamless,~     dose-selecting study to compare the efficacy of APD421 to placebo as treatment of established~     PONV, in patients who have not had prior PONV prophylaxis.~   "
85394|NCT02449278|"~     The standard treatment approach for patients with stage III-IV DLBCL is combination~     chemotherapy. Receipt of consolidation radiotherapy (RT) after effective chemotherapy was~     associated with improved in-field control and event-free survival. However, it is uncertain~     for the radiotherapy field size to treat for these patients after chemotherapy.~     Involved-field radiotherapy (IFRT) after effective chemotherapy is a common strategy for~     patients with stage III-IV DLBCL. There is not a clinical trial to research whether the~     sequential narrowed radiotherapy field size (involved-site radiotherapy, ISRT) can obtain the~     same efficacy as IFRT and decrease toxicities related to radiotherapy.~   "
85395|NCT02449265|"~     The most common option of radiotherapy for patients with limited-stage DLBCL is~     involved-field radiotherapy (IFRT). The more limited radiotherapy field size changing from~     IFRT to reasonable margin from gross tumor has been reported to maintain the high rates of~     local disease control, while minimizing the risks of radiation-induced toxicities. However,~     the research didn't analyze whether the efficacy of consolidation involved-site radiotherapy~     (ISRT) be affected by the response of chemotherapy. The biologic definition of clinical~     target volume (CTV) of ISRT and actual radiotherapy field size need to be ascertained.~   "
85396|NCT02449252|"~     Radiotherapy (RT) is an important option for patients with limited stage FL. The recommended~     approach for patients with limited stage FL by The National Comprehensive Cancer Network~     (NCCN) is 24Gy~30Gy consolidation RT following effective systemic therapy. There is no~     universal consensus for a ''standard'' RT field size in the treatment of limited stage FL.~     The involved-site radiotherapy (ISRT) has been treated effectively for these patients.~     However, the certain target volumes of ISRT need to be defined for patients with limited~     stage FL after effective chemotherapy.~   "
85397|NCT02449239|"~     Because of the high risk for development of muscle invasive disease, cystectomy is~     recommended for CIS, high-grade Ta and T1 patients who experience disease recurrence~     following intravesical therapy. Vicinium is an experimental agent that may provide an~     alternative to cystectomy~   "
85398|NCT02449226|"~     ICU patients are at high risk of ionic or metabolic disturbances during the course of their~     critical illness. Some of these disturbances might be life-threatening and require rapid~     response from physicians. Point-of-Care determination of electrolytes, glucose, hemoglobin~     and hematocrit ensures early detection (within 1 minute) of abnormal values and allows rapid~     and appropriate therapy. This technology has largely improved the quality of care in ICU.~     However, the accuracy of the measurement of those parameters had to be close enough to the~     reference method, usually perfomed in the central lab but time consuming. Recently, a novel~     generation of blood gas analyser has been released. Among them, the RapidPoint 500 is mounted~     with a 28-day cartridge which provides automatic calibrations and quality controls several~     times a day. Such a technology dramatically decreases the need for labs technical~     interventions. To date, there is no data reporting the accuracy of this device. Therefore,~     the investigators' aim is to compare the accuracy of the RapidPoint 500 with a reference~     measurement performed at the central laboratory (Beckman&Coulter AU5800 for electrolytes and~     Beckman&Coulter DXH for hemoglobin).~   "
85399|NCT02449213|"~     This prospective, longitudinal study of Chinese American immigrants will examine whether~     psychosocial factors (e.g., acculturative stress, social isolation, discrimination) are~     associated with markers of type 2 diabetes risk over time, and whether such associations are~     mediated by inflammatory pathways.~   "
85400|NCT02449200|"~     Multimodal physiotherapy involving manual therapy and exercise has demonstrated a positive~     effect on pain and disability in sub-acute and chronic cervical radiculopathy (CR) but a~     research gap exists for optimal management in the first 12 weeks and short-term natural~     history of the condition is unclear, although thought to be favourable within the first 4~     weeks. The primary aim of this single blind, 2 group randomised controlled trial (RCT) is to~     investigate the effects of a 4 week (6-8 sessions) programme of manual therapy, exercise and~     upper limb unloading tape compared to advice to stay active, on disability, pain and other~     biopsychosocial measures, in acute / sub-acute cervical radiculopathy patients. The~     hypothesis is that a 4 week multimodal physiotherapy programme will lead to changes in~     self-reported disability and pain, compared to advice to stay active, in patients with acute~     / sub-acute cervical radiculopathy. A secondary study objective is to identify whether~     variables from the baseline examination, group allocation and aetiology confirmed by MRI can~     predict outcome, as measured with the Global Rating of Change Scale (GROC). Subjects will be~     diagnosed with CR based on a diagnostic clinical prediction rule. Random group allocation,~     allocation concealment, blinded assessment and intention to treat analysis will be employed.~     Outcomes will be measured at baseline, 4 and 12 weeks. Patients' report of pain, disability~     and their rating of recovery will also be recorded by telephone interview at 6 months. An~     internal pilot feasibility study will be undertaken in advance of the main study to test~     recruitment and retention strategies. Statistical analysis of differences between groups will~     be done with ANOVAs and MANOVAs. Appropriate multivariable regression analysis will be used~     to explore predictors of outcome.~   "
85401|NCT02449187|"~     A randomized, open-label, single dose, crossover study to investigate the effect of food on~     the pharmacokinetics of JLP-1310 in healthy male volunteers.~   "
85402|NCT02449174|"~     The objective of the study is to investigate the safety of a frozen or lyophilized inoculum~     administered, respectively, by retention enema or capsules in patients with recurrent C.~     difficile associated diarrhea (RCDAD).~      This is a single center, randomized, parallel assignment, open label safety study conducted~     in subjects with RCDAD. Fifty subjects will be enrolled in the study and randomized at 1:1~     ratio to receive frozen filtered intestinal bacteria via retention enema or lyophilized donor~     intestinal bacteria. All subjects will be followed for a total of 3 years after study~     completion.~      Donors will be enrolled and screened at the laboratory in the Center for Infectious Diseases~     at University of Texas School of Public Health (UT-SPH). The donors will come from a variety~     of places, including the UT-SPH. We will screen at least 20 donors to recruit at least 15~     qualified donors.~      Recipients may self-refer but must have a physician who agrees to accept care of the patient~     following fecal microbiota transplantation (FMT). Subjects consenting to treatment at Baylor~     St. Luke's Medical Center (BSLMC) and the UT-SPH must be willing to self-pay for the FMT in~     the amount of $1,500. There will be no insurance accepted. Subjects undergoing retention~     enema will be treated as outpatients at either at BSLMC, Kelsey-Seybold Clinic, or at the~     Memorial Hermann in the Texas Medical Center. All subjects taking capsules with lyophilized~     intestinal bacteria will be seen at UT-SPH. Once the procedure is completed, the recipient's~     care will be returned to their physician. We will screen at least 75 recipients to recruit 50~     qualified recipients.~      The primary endpoint is to evaluate the safety of FMT by rectal or oral routes with secondary~     endpoint related to efficacy prevention of RCDAD. In order to monitor any health effects for~     safety, participants will be contacted pre- and 7, 14, 30 days, then monthly basis for the~     first 90 days after FMT and quarterly till 3 years after FMT. The following procedures will~     be completed: review recipient diary with the recipient to ensure that the following~     information is recorded correctly and a fresh stool sample will be collected from recipient,~     tested for C. difficile toxins and an aliquot (2mL) stored at -80C for microbiome analysis.~     Recipients will be contacted by phone for their diarrhea status on monthly basis till 90 days~     after FMT, then on quarterly basis till 3 years after FMT.~   "
85403|NCT02449161|"~     Heavy menstrual bleeding are a common reason for consultation in gynecology and are defined~     by International Federation of Gynecology and Obstetrics as the perception of menstrual~     volume increased regardless of the frequency, duration and regularity. Some studies report~     that up to 30% of women will suffer from heavy periods during their lifetime. The first line~     treatment of heavy bleeding is medical. However, a significant proportion of women require~     surgery. Until the 80s, hysterectomy was one of the only surgical options and often performed~     as the first line treatment. Since twenty years now the endometrial ablation has become a~     preferred option for dysfunctional uterine bleeding and avoids hysterectomy in a significant~     proportion of patients suffering from this type of problem. Endometrial ablation is much less~     invasive and morbid than hysterectomy, however, many patients do not achieve a complete~     amenorrhea with endometrial ablation and about 15% may have to require a new intervention,~     such as hysterectomy, following the persistence of menstrual problems. A Cochrane review~     published in 2013 showed that the satisfaction rate following endometrial ablation is high at~     70-80% and about 35% of women have amenorrhea. The complete destruction of the endometrium is~     the most important predictor of the success of the procedure. Studies have shown that better~     results are obtained when the surgery is performed when the endometrium is thin or~     immediately following menses or following administration of a hormonal agent causes atrophy~     of the endometrium. One of the agents studied to prepare the endometrium before ablation is~     medroxyprogesterone acetate (MPA) as injectables (DMPA) and oral. Progestins have an~     antiproliferative effect on the endometrium. In recent years, numerous studies have examined~     the use of various agents preoperatively, including MPA and DMPA to facilitate surgery by~     reducing the thickness of the endometrium. However, few studies have focused on the~     conditions of the post-operative period to promote the therapeutic response to the~     intervention. The investigators hypothesis is whether the MPA administered in immediate~     post-operative would inhibit proliferation of endometrial cells responsible for the~     persistence of menstruation and optimize the clinical response to endometrial ablation.~   "
85404|NCT02449148|"~     This study evaluates the effect of intermittent calorie restriction versus continued calorie~     restriction on weight loss, gene expression profile of subcutaneous adipose tissue and~     abdominal fat distribution.~   "
85405|NCT02449135|"~     The purpose of this study is to evaluate the safety and efficacy of nano drug interventional~     therapy using digital subtraction angiography（DSA） for pancreatic cancer. The nano drug is~     made by mixing Gemzar® with Compound Glycyrrhizin Injection.~   "
85406|NCT02449122|"~     The purpose of this study is to evaluate the safety and efficacy of nano drug interventional~     therapy using digital subtraction angiography（DSA） for lung cancer. The nano drug is made by~     mixing Gemzar® with Compound Glycyrrhizin Injection.~   "
85407|NCT02449109|"~     The purpose of this study is to evaluate the safety and efficacy of nano drug（Gemzar® mix~     with Compound Glycyrrhizin Injection） interventional therapy using digital subtraction~     angiography（DSA） for liver cancer.~   "
85408|NCT02449096|"~     Background: An anatomical reconstruction of ankle congruity is an important prerequisite in~     the operative treatment of acute ankle fractures. But, despite an anatomic reduction,~     patients suffer from residual problems like chronic pain, stiffness, persistent swelling and~     instability after these fractures. There is growing evidence, that this poor outcome is~     related to the concomitant traumatic intraarticular pathology. Therefore, supplementary ankle~     arthroscopy has been proposed in acute ankle fractures as it is a valuable tool to confirm~     the anatomic reposition and to further identify and manage associated intraarticular~     injuries. The arthroscopic treatment of these pathologies might result in a better outcome~     after complex ankle fractures. Nevertheless, until now, the vast majority of ankle fractures~     are managed by open procedures only. Still, indications for arthroscopically assisted open~     reduction and internal fixation (AORIF) are not clearly stated, and the effectiveness of~     AORIF compared with open reduction and internal fixation (ORIF) has not yet been determined~     for complex ankle fractures. In this context, only a prospective randomized study can~     sufficiently answer these open questions. Therefore, the investigators plan a randomized~     controlled trial intended to report the short-, midterm- and long-term follow-up of patients~     who underwent operative treatment of acute ankle fractures - with and without ankle~     arthroscopy.~      Methods/Study design: The investigators will perform a randomized controlled trial evaluating~     the effect of AORIF compared to ORIF with a sample size of 40 patients per group. The~     investigators include patients with an acute ankle fracture after written informed consent.~     Primary outcome of the investigators' study is the difference of the AOFAS score (American~     Orthopedic Foot and Ankle Society) between the intervention (AORIF) and comparison (ORIF)~     group after a follow-up of 2 years. Several secondary outcome parameters will be assessed as~     well. Statistical analysis will be performed using a two-sided Student`s t-test.~      Discussion: Until today, there are only two randomized controlled trials evaluating the~     effect of open reduction and internal fixation (ORIF) compared to arthroscopically assisted~     open reduction and internal fixation (AORIF). Both studies only included patients with~     isolated fractures of the distal fibula at the level of the syndesmosis. These are the most~     simple fractures that are regularly treated operatively. Both studies documented a high~     incidence of intraarticular disorders in the AORIF group, but only one could show significant~     better results in the AORIF group. Moreover, several other studies could consistently~     demonstrate that the intraarticular damage is even more pronounced the more complex the~     fracture is. Consequently, a more distinctive effect of arthroscopy in complex fractures~     involving two malleoli or more has to be assumed when compared to these simple fractures.~   "
85409|NCT02449083|"~     There is preliminary evidence that a dynamic T2 Preparations Puls sequence by cardiac magnet~     resonance imaging can differentiate between oxygenated and deoxygenated blood.~      In adult patients with inborn heart defects this has not yet been researched.~     Therefore,patients with ventriculoperitoneal shunt, septal and atrio-septal shunt should be~     examined. Also, patients with chronic obstructive pulmonary disease should be examined.~      The aim of this study is the validation of a novel magnet resonance sequence in terms of a~     distinction of oxygenated blood to deoxygenated blood in comparison to invasive method of~     measuring cardiac catheterization.~   "
85410|NCT02449070|"~     The purpose of this study is to determine whether nicorandil reduce cardiac infarct size in~     patient with ST-segment elevation acute myocardial infarction.~   "
85411|NCT02449057|"~     Arizona has created a pilot program for juvenile probationers called Juveniles under~     Supervision and Treatment (JUST), which includes swift and certain, but modest responses, to~     technical violations of the terms of juvenile probation. JUST targets high- and medium-risk~     juvenile probationers and its stated objective is to reduce violations and overall~     incarceration of youth in the program. The JUST pilot is being implemented under the~     authority of the Arizona Governor's Office for Children, Youth and Families (GOCYF) and the~     Administrative Office of the Courts (AOC).~   "
85415|NCT02449005|"~     Systemically healthy periodontitis patients are recruited from new referrals to the~     Department of Periodontology and Biology of Implants, AUTh. After completion of non-surgical~     periodontal treatment those subjects who have at least one interdental osseous defect with~     probing pocket depth and clinical attachment level of ≥ 6mm and an intrabony component of ≥~     3mm with no endodontic or furcation involvement are randomly allocated into one of the three~     treatment groups. Group A receives regenerative treatment using autologous bone marrow~     mesenchymal stem cells free of animal derived reagents, produced in clean room facilities and~     seeded into collagen scaffolds enriched with fibrin glue; in Group B, a collagen fleece~     enriched with fibrin glue devoid of stem cells fills the osseous defect; Group C receives~     open flap debridement retaining the soft wall of the defect. Thereafter, subjects are~     followed for 12 months and are repeatedly assessed based on clinical, radiographic,~     immunological and microbiological parameters.~   "
85416|NCT02448992|"~     Background. During the clinical course of patients with locoregionally advanced~     non-small-cell lung cancer (LA-NSCLC) who have undergone aggressive treatment, brain~     metastasis (BM) is a frequent seen pattern of disease relapse, which cannot be ignored. It~     still remains unresolved whether prophylactic cranial irradiation (PCI) via whole brain~     radiotherapy (WBRT) should be recommended for NSCLC patients with stage III or pathologically~     nodal positive disease. Actually, PCI would significantly decrease the incidence of BM;~     however, potential WBRT-related neurocognitive function (NCF) sequelae are indeed a concern,~     which has made PCI seldom applied in clinical practice. In terms of the time course of~     WBRT-induced NCF decline, it might vary considerably according to the specific domains which~     are selected to be measured. Early neurocognitive decline principally involve impairments of~     episodic memory, which has been significantly associated with functions of the hippocampus.~     This study thus aims to explore the impact of PCI on the subsequent risk of developing BM and~     the multi-domain neurobehavioral functions in our eligible patients.~      Methods. Potentially eligible subjects are postoperative NSCLC patients with a status of~     pathologically nodal metastasis (pN+). Patients randomly assigned to the PCI arm will undergo~     the course of hippocampal-sparing PCI after they complete the fourth course of adjuvant~     platinum-based chemotherapy. Radiotherapy dose will be 3000 cGy in 15 fractions during three~     weeks. Except for the administration of hippocampal-sparing PCI, patients assigned to the~     observation arm should receive the same baseline and follow-up brain imaging examinations and~     neurocognitive assessments as those in PCI arm. Accordingly, a battery of neuropsychological~     measures, which includes 7 standardized neuropsychological tests (e.g., executive functions,~     verbal & non-verbal memory, working memory, and psychomotor speed), is used to evaluate~     neurobehavioral functions for our registered patients.~      Expected results. This randomized controlled study aims to verify that the incidence of BM~     still can significantly be reduced by hippocampal-sparing PCI; additionally, NCF preservation~     regarding neurobehavioral assessments might also be achieved by hippocampal-sparing PCI as~     compared with the observation arm without PCI. No matter what the final results present, it~     is believed that this randomized controlled trial (RCT) will provide us solid evidence~     concerning the exact value of hippocampal-sparing PCI in our patient setting.~   "
85417|NCT02448979|"~     Esophageal carcinoma is an aggressive malignant disease with poor prognosis. Surgical~     resection remains the most effective method for this malignancy. Although different~     approaches have been studied for the surgical resection of thoracic esophageal cancer, little~     evidence has been achieved due to lack of large scale multicenter randomized trials with~     regard to this issue: whether left transthoracic approach or right transthoracic approach is~     the optimal surgical approach for treating middle and lower thoracic esophageal cancer~     without upper mediastinal lymph node metastasis. The purpose of this study is to compare the~     postoperative local recurrence rate and long-term outcome of esophagectomy through left and~     right transthoracic approach in the middle and lower thoracic esophageal cancer patients~     without preoperative upper mediastinal lymph node metastasis.~   "
85418|NCT02448966|"~     Esophageal carcinoma is an aggressive malignancy with poor prognosis. Surgical resection~     remains the most effective method for this malignant disease. VATS esophagectomy has become~     more and more popular in China and around the world. Although VATS esophagectomy has been~     proven to be effective in preventing respiratory complications, there is still no ample~     evidences to demonstrate that VATS esophagectomy is as effective as traditional~     three-incision esophagectomy in lymph node dissection and is equal or superior in long-term~     survival. The purpose of this large scale prospective observational study is to compare the~     minimally invasive thorascopic/laparoscopic esophagectomy with traditional three-incision~     esophagectomy in lymph node dissection, postoperative recovery, postoperative complications,~     and long-term survival.~   "
85419|NCT02448953|"~     The purpose of this study is to compare the lymph node dissection results and prognosis in~     thoracic esophageal carcinoma patients without cervical lymph node involvement by~     preoperative CT and/or ultrasound treated by two-field lymphadenectomy or three-field~     lymphadenectomy.Another purpose of this study is to clarify whether the lymph node along the~     right recurrent laryngeal nerve can be taken as the sentinel lymph node which is able to~     indicate neck lymph node metastasis and necessity for three-field lymphadenectomy.~   "
85420|NCT02448940|"~     The investigators aimed to study the effect of supplementation with species of Lactobacillus~     on anthropometric measurements, body composition, appetite and serum lipid profile in~     overweight and obese adults~   "
85421|NCT02448927|"~     This is a randomized trial that will evaluate the role of balloon aortic valvuloplasty (BAV)~     on the outcome of patients undergoing transcatheter aortic valve implantation (TAVI)~     procedure. Patients will undergo a physical exam, coronary angiography and computed~     tomography angiography before TAVI. The randomization for direct or non-direct TAVI ( with~     BAV or without BAV) will take place 24 hours prior to the procedure by the core lab at~     Hippokration Hospital in Athens. The same lab will analyze in blind fashion the results of~     all the imaging modalities for each patient. The patients will be followed during the~     hospital stay and at 30 days and 1 year thereafter by echocardiography. The procedure of~     predilatation will be at the operator's discretion.~   "
85422|NCT02448914|"~     This study evaluates the continuous addition of entacapone to infused levodopa and carbidopa~     on the pharmacokinetic (PK) profile in patients with advanced Parkinson's disease (PD). All~     patients will receive both study drugs, i.e. TRIGEL (levodopa, carbidopa, and entacapone) and~     Duodopa (levodopa and carbidopa), in randomized order.~   "
85423|NCT02448901|"~     The influence of different doses of edoxaban on physical characteristics of the clot and~     thrombin generation kinetics in blood samples will be studied by in vitro spiking of blood~     samples collected from patients treated for heart failure (with and without~     hypercoagulability) and from healthy volunteers (with and without hypercoagulability). This~     in vitro experiment will help us to:~      (i) detect qualitative anticlotting properties of edoxaban. (ii) quantify the anticlotting~     properties of edoxaban.~   "
85424|NCT02448888|"~     Objective: The purpose of this study is to investigate the effects of a adapted exercise~     program and general exercise recommendations compared with only general exercise~     recommendations for the management of chronic back pain among the workers of BSH (Bosch~     Siemens Hausgeräte), a manufacturing company.~   "
85426|NCT02448862|"~     In this retrospective study, postoperative pain score, PCA-related complications, the risk~     factors for requirement of rescue analgesics and antiemetics will be evaluated in young and~     elderly patients, respectively, using fentanyl-based IV PCA during postoperative 48 hours~     after various surgeries.~   "
85427|NCT02448849|"~     Nonunion of long bones would occur in almost 10% of fractures and because of its long term~     and complicated treatment, is known as a therapeutic challenge for both of the surgeons and~     patients.~      Cell therapy is useful in treatment of nonunion and mesenchymal stromal/stem cells are the~     best candidates for this kind of treatment.~      Percutaneous implantation of autologous bone marrow derived mesenchymal stromal/stem cell in~     combination with PL will be done in 30 patients with tibia nonunion. The other 30 patients as~     the control group will receive placebo. The patients will be followed at 2weeks, 3months, 6m~     and 12 months after implantation.~      The Spss(v16) software will be used for data analysis.~   "
85428|NCT02448836|"~     Premenstrual dysphoric disorder (PMDD) is a hormone-dependent mental condition that causes~     significant suffering in 5% of women of reproductive age worldwide. The prominent symptoms~     are depressed mood, irritability, mood lability and anxiety. Treatment options for PMDD are~     limited, with 40% non-responders.~      Deep transcranial magnetic stimulation (dTMS) is a novel therapeutic technique, which is~     based on modulating neural activity by inducing an electric field in the brain. To date, dTMS~     was found to be an effective treatment for depression, which is highly comorbid with PMDD.~      The investigators propose to study the effect of dTMS on PMDD patients in a prospective~     treatment study.~   "
85429|NCT02448823|"~     The study will test a novel demand generation strategy, Stylish Man/Stylish Living, to~     increase uptake of Combined HIV Prevention (CHP) in Rakai, Uganda. CHP includes~     evidence-based interventions, including safe voluntary medical male circumcision (VMMC),~     antiretroviral therapy (ART), prevention of mother to child transmission (p-MTCT) and~     behavioral interventions. With President's Emergency Fund for AIDS Relief (PEPFAR) funds, the~     Rakai Health Sciences Program (RHSP) provides CHP in Rakai District, Uganda. Our ongoing 54~     village Rakai Community Cohort Study (RCCS), with community HIV prevalence ranging from 6% to~     42%, provides longitudinal data on rates of CHP coverage and on HIV incidence. The~     investigators have preliminary evidence that CHP is reducing HIV incidence in Rakai, but~     coverage remains suboptimal (as elsewhere in Africa), particularly in men, reducing program~     impact. Our data suggest that CHP supply is not the limiting factor, but that there is a~     deficit in demand.~      Based on extensive qualitative research, the investigators have developed and piloted an~     innovative male-focused CHP demand generation strategy, the Stylish Man/Stylish Living~     Program (SMLP) which is male-friendly without excluding women. The SMLP strives to~     demedicalize CHP by de-emphasizing health-focused messages and instead stressing taking~     charge of your life. The SMLP has two distinct but related elements: (1) mass media (MM) via~     radio and posters; and (2) community-level mobilization via the Stylish Man/Stylish Living~     Event (SMLEvent) which includes multimedia media (the Stylish Van, videos, music, health~     promoters) into which the investigators have embedded CHP promotion, and immediate access to~     services (mobile camps which offer VMMC camps, HIV testing and counseling services, referral~     for ART including referral for p-MTCT, and contraceptive services). In this study, the~     investigators will conduct a 4.5 year cluster randomized trial of MM/mobile service~     camps+SMLEvents (intervention arm) compared to MM/mobile service camps conducted without~     SMLEvents (control), in 25 RCCS communities per arm aggregated into ~10 clusters per arm (50~     communities in all). The primary outcome will be intent-to-treat community-level rates of CHP~     coverage by arm, and service statistics on use of mobile camp services by arm. The~     investigators will also monitor rates of key behaviors and HIV incidence, and compare them~     between arms and to rates observed in communities in each arm prior to study initiation~     (secondary outcomes).~   "
85430|NCT02448810|"~     The purpose of this study is to evaluate the safety and tolerability of BAX69 in combination~     with 5-fluorouracil (5-FU)/leucovorin (LV) or panitumumab to determine the recommended phase~     II dose (RP2D) of each combination; and to compare the efficacy between BAX69 in combination~     with 5-FU/LV for subjects with KRAS or NRAS mutated tumor (mt) or panitumumab, for subjects~     with KRAS and NRAS wild type tumor (wt) and standard of care (SoC) per investigator choice as~     third or fourth treatment line in subjects with progressive measurable metastatic colorectal~     cancer (mCRC).~   "
85431|NCT02448797|"~     Adjuvant therapy has been proved effective in treating earlier stage or less advanced~     non-small-cell lung cancer. This study is designed to evaluate the efficacy of icotinib as~     adjuvant therapy in treating stage II-IIIA non-small cell lung cancer patients with EGFR~     mutation. The primary endpoint is disease-free survival.~   "
85432|NCT02448784|"~     To investigate long term safety (especially about Parkinsonism) and efficacy of donepezil~     hydrochloride in clinical practice as well as its proper use information in participants with~     DLB.~   "
85433|NCT02448771|"~     This research study is studying a drug called Palbociclib in combination with Bazedoxifene (a~     type of endocrine therapy, which prevents breast cancer cell growth by blocking estrogen~     stimulation) as a possible treatment for this diagnosis.~      The names of the study interventions involved in this study are:~        -  Palbociclib~        -  Bazedoxifene~   "
85434|NCT02448758|"~     The investigators propose to create a database at the regional level, the principle is to~     include all patients in whom a mutation was detected from a single platform (Lille). The~     creation of this regional cohort, smaller than the national cohort of Biomarkers France, will~     perform a more comprehensive collection of clinical data, and molecular monitoring data of~     patients included. To increase the completeness of the collection of information, it will not~     be based on voluntary prescribing clinician but will be largely carried out by CRA dedicated~     to this activity.~   "
85435|NCT02448745|"~     A cluster-randomized control trial will study the effect of insecticide-treated wall lining~     on malaria transmission in Bomi County, Liberia. Half of the villages enrolled in the study~     will receive insecticide-treated wall lining covering their walls and ceilings in addition to~     long-lasting insecticidal nets, while the other half will be protected by existing~     long-lasting insecticidal nets.~   "
85436|NCT02448732|"~     The purpose of this study is to investigate the role of intravitreal injection of~     anti-vascular endothelial growth factor (VEGF) therapy in prevention and control of~     ophthalmological neovascular diseases, in order to find a new strategy of treatment for~     ophthalmological neovascular diseases~   "
85437|NCT02448719|"~     The purpose of this study is to characterize the safety and tolerability profile of TAK-792~     when administered as a single oral dose in healthy Japanese and Caucasian male participants.~   "
85438|NCT02448706|"~     The goal of this project is to find out if the way a hearing aid processes a sound signal~     should be determined in part by an individual's cognitive characteristics. We anticipate that~     the outcome of this work will be a battery of assessments that will guide hearing aid~     processing for older patients with hearing loss.~   "
85439|NCT02448693|"~     This study is designed to evaluate the diagnostic accuracy of Narrow Band Imaging (NBI)~     compared with High Definition White Light colonoscopy (WLE) for detection of residual~     neoplasia in subjects with piecemeal polypectomy scars.~   "
85440|NCT02448680|"~     The purpose of the study is to assess the safety, efficacy and pharmacokinetics of 2 separate~     dose regimens (75µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for the~     treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII~     or IX in 12 patients ( birth to <6 years old), and 12 patients (≥6 years old to <12 years~     old).~   "
85441|NCT02448667|"~     Patients suffering from the metabolic myopathy Glycogen Storage Disease type IIIa (GSDIIIa)~     have a problem releasing sugar stored in cells that is needed for energy production. This~     causes several systemic impairments, but only recently have the exercise-related symptoms in~     the muscles been examined. A previous study showed signs that intravenous infusion of glucose~     relieves some of these symptoms. The purpose of this study is to investigate in a randomized~     and placebo-controlled fashion whether oral ingestion of sugar can alleviate muscular~     symptoms in patients with GSDIIIa.~   "
85442|NCT02448654|"~     The purpose of this study is to use a medication tolcapone and or placebo to test if the~     symptoms of nicotine withdrawal lessens , and or changes in smoking urges, and mental~     reasoning in female smokers over a 72 hour period.~   "
85443|NCT02448641|"~     Controlled study of stereotactic, intracranial injection of SB623 cells in patients with~     fixed motor deficits from ischemic stroke~   "
85444|NCT02448628|"~     This study is a multi-center, open label, dose titration, exploratory study to evaluate~     efficacy and safety of CS-3150 in Japanese hypertensive patients with moderate renal~     impairment. Primary endpoint is change from baseline in sitting systolic and diastolic blood~     pressure.~   "
85445|NCT02448615|"~     In 2010, 7.6 million children under the age of five died worldwide and yet the causes of only~     2.7% (0.205 million) of these deaths were medically certified. A thorough understanding of~     the causes of child mortality is necessary to guide research efforts aimed at tackling this~     important global health problem. Prospective birth cohort studies present an opportunity to~     examine the relationships between early-life exposures and multiple health and non-health~     related outcomes including death, illness, and socioeconomic factors. In this study, the~     investigators will provide insight into the underlying causes of child mortality by~     collecting data on early-life exposures and health and non-health related outcomes in the~     first year of life.~   "
85446|NCT02448602|"~     With primary insomnia as the research object, by the method of multi-center RCT and needle~     single cavity and different acupoints compatibility treatment for primary insomnia, to~     Pittsburgh sleep quality index(PSQI) and evaluation, sleep log evaluation and~     Polysomnogram(PSG) as the means, such as the single cavity with different acupoints~     compatibility evaluate clinical curative effect of treating primary insomnia.~   "
85447|NCT02448589|"~     A Phase 1, Open-Label, Non-Randomized, Dose-Escalating Safety, Tolerability, Pharmacokinetic~     and Pharmacodynamic Study of TAS-119 in Patients with Advanced Solid Tumors.~   "
85448|NCT02448576|"~     The purpose of this study is to compare whether prophylactic cranial irradiation in patients~     with advanced triple negative breast cancer who had a response to first line chemotherapy~     could prolong brain-metastasis free survival.~   "
85449|NCT02448563|"~     In this proposal, the investigators will develop a culturally-tailored, 8-week clinic-based~     weight loss program to reduce obesity among postpartum African American (AA) adult women that~     can be integrated into a postpartum care model within a clinical setting.~   "
85450|NCT02448550|"~     The purpose of this trial is to determine whether bivalirudin is non-inferior to~     unfractionated heparin in patients with stable angina, unstable angina, or non-ST segment~     elevation myocardial infarction undergoing percutaneous coronary intervention.~   "
85451|NCT02448537|"~     This research study is investigating a drug called PM01183 alone and in combination with~     chemotherapy drugs called gemcitabine or doxorubicin as a possible treatment for metastatic~     or unresectable Sarcoma.~   "
85452|NCT02448524|"~     -  To evaluate the safety and efficacy of MiStent drug (sirolimus)-eluting stent system in~          the treatment of coronary heart disease (CHD) in patients with primary in situ CHD (de~          novo);~        -  To evaluate operating performance of the MiStent drug (sirolimus)-eluting coronary stent~          system.~   "
85453|NCT02448511|"~     This study evaluates the efficacy of local application of ozone gas in healing of infected~     ulcers. Half the participants received conventional treatment with placebo generator and the~     other half received conventional treatment with ozone generator.~   "
85454|NCT02448498|"~     The Strength Training Regimen in Normal Weight Diabetics (STRONG-D) study will examine the~     effectiveness of different exercise regimen types in controlling diabetes for the normal~     weight type 2 diabetes population.~   "
85455|NCT02448485|"~     TASS-2 (Tyrolean Aortic Stenosis Study-2) aims to characterize the clinical value of~     minimally elevated troponin T plasma levels both in patients with asymptomatic and symtomatic~     aortic stenosis.~   "
85456|NCT02448472|"~     Sepsis is a common cause for morbidity and mortality in critically ill patients. In USA, the~     incidence of sepsis is about 3/1000 population. However, the incidence of sepsis varies among~     different clinic trails. In addition, clinician empirical select antibiotic according to the~     epidemiology of sepsis, however, the etiology of sepsis is various in different studies. In~     China, the MDRO is much higher than western country. There is no study about the epidemiology~     of sepsis in China. Therefore, it is necessary to conduct a study about it in China.~   "
85457|NCT02448459|"~     This is a pilot study evaluating the effect of a simplified low-cost (friendly) controlled~     ovarian stimulation using clomiphene citrate, letrozole, and Corifollitropin Alfa on the~     number of oocytes retrieved.~   "
85458|NCT02448446|"~     This is an open-label, Phase I/II study of intravitreally administered 0.3mg ranibizumab in~     subjects with diabetic macular edema and lipid exudates in the central subfield.~   "
85492|NCT02448004|"~     The primary objective of this study is to characterize the absorption and metabolic pathways~     of JNJ-63623872, and the excretion of the compound and its metabolites, after single oral~     dosing of 14C-JNJ-63623872 in healthy adult male participants.~   "
85517|NCT02447679|"~     This single-centered phase II clinical study is to obtain preliminary information on 1-year~     recurrence-free survival rate, recurrence-free survival and safety profile of thalidomide in~     combination with tegafur-uracil in hepatocellular carcinoma after hepatectomy and explore~     biomarkers(VEGF/bFGF) for thalidomide response.~   "
85459|NCT02448433|"~     Bright light therapy is an established treatment pathway for sleep and circadian disorders~     and evidence suggests that it has antidepressant effects. The underlying mechanisms of these~     antidepressant effects are not fully understood and results from previous studies are~     somewhat variable. One of the important limitations of previous depression studies has been~     the heterogeneity of samples in which bright light therapy has been administered.~      The main aim of this study is to evaluate whether the antidepressant effects of phototherapy~     in young persons with depression are modulated by changes in the sleep-wake cycle. We~     hypothesize that more pronounce initial sleep-phase delay will predict better antidepressant~     response to phototherapy and that the magnitude of changes in depressive symptoms across the~     course of the intervention will correlate with changes in the sleep-wake cycle.~   "
85460|NCT02448420|"~     This is a phase II, prospective, open-label, multicentre, Simon's two-stage-design study of~     the combination of palbociclib plus trastuzumab, with or without letrozole, in~     post-menopausal patients with HER2-positive locally advanced or metastatic breast cancer~     (MBC) who have received chemotherapy and treatment with trastuzumab for their metastatic~     disease.The aim of the PATRICIA study is test the hypothesis that the addition of Palbociclib~     to standard therapy is well tolerated and can provide a benefit in progression-free survival~     in patients with HER2-positive breast cancer previously treated for their metastatic disease.~   "
85461|NCT02448407|"~     Platelet-rich plasma (PRP), due to its high content of cytokines, bioactive proteins and~     platelet growth factors, may contribute to diminish the pain of arthritic knee. It was also~     recently recognized a regenerative cell potential improving the concentration of hyaluronic~     acid and stabilizing angiogenesis in arthritic knees~      This study therefore seeks to assess the analgesic power of PRP in osteoarthritic knees~     intraarticularly infiltrated, and which patients would benefit most from treatment,~     eliminating false expectations in the rest.~   "
85462|NCT02448394|"~     This study, to be conducted in southern Ethiopia, is a randomized community trial, evaluating~     the use of local community support workers who provide for HIV patients education,~     counseling/social support, and linkage to the HIV Clinic. Patients will be followed for at~     least three years, with a primary goal of improving retention in HIV care, and secondary~     goals of improving client knowledge, attitudes about being HIV-positive, feelings of social~     support and clinical health status.~   "
85463|NCT02448381|"~     To evaluate the use of SGX301, a topical photosensitizing agent, to treat patients with~     patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).~   "
85464|NCT02448368|"~     The purpose of this study is to determine the relative bioavailability of RDEA3170 capsules~     compared with RDEA3170 tablets.~   "
85465|NCT02448355|"~     All patients undergoing carotid endarterectomy in Shaare Zedek Medical Hospital, during about~     1 year, will be offered to participate.~      Retinal and choroidal structural changes will be assessed using swept-source OCT technology~   "
85466|NCT02448342|"~     Multi center, randomized controlled study, to determine if a significant decrease in the rate~     of heart failure re-hospitalizations occurs during a follow-up period when - ReDS guided~     treatment is used as an adjunct to standard of care.~   "
85467|NCT02448329|"~     This study is a single arm, single center phase II study of AZD1775 in combination with~     paclitaxel in patients with advanced gastric adenocarcinoma harboring TP53 mutation as a~     second-line chemotherapy.~      Patients will receive AZD 1775 plus weekly paclitaxel combination regimen. The arm is~     composed of 25 patients.~      AZD1775 225 mg BID q 12 hours (x 5 doses) administered days 1~3 + paclitaxel 80 mg/m2 given~     days 1, 8 and 15 of a 28 day cycle.~      Tumour evaluation using Response Evaluation Criteria in Solid Tumors 1.1 will be conducted at~     screening every 16 weeks until objective disease progression .~   "
85468|NCT02448316|"~     The purpose of this study is to compare in a randomized controlled trial the effect of~     endoscopic operation with the standard conservative treatmentprotocol with training~     supplemented with 1-3 injections of glucocorticoids in patients with chronic plantar~     fasciopathia.~   "
85469|NCT02448303|"~     Pembrolizumab alone and in combination with acalabrutinib in subjects with advanced non-small~     cell lung cancer.~   "
85470|NCT02448290|"~     This study is a single-arm, phase II study of selumetinib in combination with docetaxel in~     patients with advanced gastric adenocarcinoma harboring MEK signature, RAS mutation or~     amplification as a second line chemotherapy.~      Selumetinib will be administered orally 75mg twice a day continuously. Docetaxel will be~     administered as an IV infusion over 1 hour at 60 mg/m2 every 3 week of a 21 days schedule.~   "
85471|NCT02448277|"~     Nasotracheal intubation (NTI) is usually required in patients undergoing maxillofacial~     surgery. Though video-scopes have been demonstrated to well perform in oral endotracheal~     intubation, limited information presents in NTI. The aim of the study is to compare the~     efficacy of video-scopes in NTI and compared with the traditional direct laryngoscope.~   "
85472|NCT02448264|"~     This is a 3-part Phase 1 dose-ranging study to evaluate the safety, tolerability,~     pharmacokinetics and pharmacodynamics of single (Part 1) and multiple (Part 2) ascending~     doses of BCX7353 in healthy subjects, and single and multiple doses of BCX7353 in healthy~     Japanese subjects. Pharmacokinetics is an analysis of how the body handles the study drug~     BCX7353 and pharmacodynamics is an analysis of the activity the study drug BCX7353 may have~     in the body.~   "
85473|NCT02448251|"~     AC0010MA is a new, irreversible, Epidermal Growth Factor Receptor (EGFR) mutation selective~     Tyrosine Kinase Inhibitor. Aim at local advanced or metastatic non-small cell lung cancer~     patients with EGFR mutation or T790M drug-resistant mutation. The molecular mechanism: by~     irreversible combining the EGFR-RTKs ATP binding site of cell, selectively suppress the~     activities of EGFR tyrosine kinase phosphorylation, block the signal transduction pathway of~     EGFR and inhibit the function of ras/raf/MAPK downstream, thus block the tumor cell growth by~     EGFR induction, and promotes apoptosis. AC0010MA Maleate Capsules has three characters: 1.~     Irreversible binding to EGFR; 2. Effectively suppresses the tumor cell with EGFR mutant while~     has no suppression to EGFR wild-type cell; 3. Efficient suppress the tumor cell with EGFR~     T790M drug-resistant mutation.~   "
85503|NCT02447861|"~     The 3q29 deletion syndrome is caused by a deletion of a small part of human chromosome 3, and~     the duplication syndrome is caused by a duplication of this same small region. The purpose of~     this study is to understand the medical and behavioral consequences of these syndromes.~   "
85474|NCT02448238|"~     The composition of the intestinal bacterial flora effects gut immunologic function and~     intestinal barrier integrity. HIV infection impairs gut immune and epithelial function~     resulting in an altered gut bacterial flora and leakage of gut bacterial products into the~     bloodstream. These bacterial products can overstimulate the immune system leading to~     increased inflammation and HIV disease progression. The investigators will investigate~     whether oral supplementation of certain beneficial probiotic bacteria may attenuate these~     processes in HIV infected women in Mali, Africa.~      This is a single arm study to evaluate the effect of 12 weeks of combination oral probiotic~     supplementation (VSL#3, Sigma-Tau Pharmaceuticals - containing 9 × 1011 bacteria of 8~     species: S. thermophilus, Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium~     infantis, Lactobacillus plantarum, Lactobacillus acidophilus, Lactobacillus paracasei, and~     Lactobacillus bulgaricus) on plasma biomarkers of immune cell activation, and inflammation.~     The study population will be 50 chronically HIV-infected but generally healthy, non-pregnant,~     Malian women subjects with CD4+ T-cell count ≥ 350 cells/mm3 who are not receiving~     antiretroviral therapy. Blood plasma/serum and fecal sampling will occur at baseline, 4, and~     12 week as well as at 24 weeks. At these time points, probiotic will be dispensed, a medical~     history will be obtained, and adherence will be assessed. Prior to study entry, subjects will~     have eligibility and safety labs will be obtained and detailed baseline medical and symptom~     histories, demographics, weight, and stool frequency information will be recorded. A stress~     assessment questionnaire will be completed at baseline and week 12 to determine the effect of~     this intervention on stress levels.~      The primary study outcome is to assess change (baseline to 12 week) in plasma soluble CD14 (a~     marker of monocyte response to bacterial endotoxin which has been associated with mortality)~     with study probiotic. Other outcomes will include assessing change (baseline to 12 week) in~     plasma interleukin-6, soluble CD163 (another monocyte activation marker), d-dimer (a marker~     of coagulopathy), intestinal fatty acid binding protein (a marker of gut epithelial cell~     injury) and fecal calprotectin (a marker of gut inflammation), as well as CD4+ T-cell counts,~     self reported stool quality (using the Bristol Stool Scale), safety and tolerability of the~     VSL#3 probiotic, and level of stress.~   "
85475|NCT02448225|"~     This clinical trial compares fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG)~     positron emission tomography (PET)/computed tomography (CT) to the standard of care~     fluorodeoxyglucose F-18 (18F-FDG) PET/CT in imaging patients with newly diagnosed lung cancer~     or indeterminate pulmonary nodules. PET/CT uses a radioactive glutamate (one of the common~     building blocks of protein) called 18F-FSPG which may be able to recognize differences~     between tumor and healthy tissue. Since tumor cells are growing, they need to make protein,~     and other building blocks, for cell growth that are made from glutamate and other molecules.~     PET/CT using a radioactive glutamate may be a more effective method of diagnosing lung cancer~     than the standard PET/CT using a radioactive glucose (sugar), such as 18F-FDG.~   "
85476|NCT02448212|"~     The purpose of this study is to evaluate the binding of a novel tracer, [11C]TASP0410699,~     using Positron Emission Tomography (PET) scans with or without dosing of TS-121~   "
85477|NCT02448199|"~     Phase III Study, double-blind, comparing association of anti-inflammatory and anti-rheumatic~     in 375 subjects with knee osteoarthritis.~   "
85478|NCT02448186|"~     The proposed study will adapt a cognitive behavioral intervention to support high-risk MSM's~     adaptive coping with minority stress, alleviate associated depression and anxiety, and reduce~     HIV risk behavior. The adapted intervention is expected to increase awareness of the~     unhealthy impact of minority stress; facilitate objective self-schemas in the face of~     minority stress; and strengthen one's skills and self-efficacy for managing minority stress~     and associated anxiety and depression to reduce risk for acquiring HIV.~   "
85479|NCT02448173|"~     OncoVAX® is the first cancer vaccine that both prevents cancer recurrence and~      addresses the diversity of cancer cells. In this pivotal randomized, multicenter Phase~      IIIb study in patients with Stage II colon cancer, OncoVAX is designed to use a patient's~      own cancer cells to mobilize the body's immune system to prevent the return of colon~      cancer following surgery.~   "
85480|NCT02448160|"~     The study will be a single centre, open-label trial. The patients will have a diagnosis of~     refractory ascites and will meet specified inclusion/exclusion criteria Informed consent will~     be obtained from all patients. All patients will have an alfapump surgically inserted and in~     addition will receive 8g of salt-poor Human Albumin Solution (20%) per 1 litre of Ascites~     drained. This Intravenous administration will be intermittent (every month) and will take~     place as a day patient. Patients will also receive standard of care, which may include, but~     is not limited to, administration of diuretics, paracentesis and consideration for orthotopic~     liver transplantation.~   "
85481|NCT02448147|"~     BACKGROUND: The physiopathology of the heart failure involves compensatory mechanisms as~     exacerbated neurohormonal activity, endothelial dysfunction and consequently the muscle~     disability and exercise intolerance. The interval exercise training has been proposed as one~     efficient method to heart failure patients. It seems that the main mechanism involved in the~     benefit of the interval exercise training is shear stress. AIM: To study the interval~     exercise training versus the continuous exercise training in the sympathetic activity and in~     the peripheral muscle perfusion in heart failure patients. Moreover, we will evaluate the~     muscle apoptosis, microRNA in plasma and muscle biopsy, biomarkers levels of inflammation,~     quality of life and exercise capacity. METODOLOGY: Will be selected 40 patients (male and~     female) with age between 30 and 60 years, left ventricular ejection fraction less than 40%~     and functional class I, II and III. These patients will be randomized into three groups:~     Interval (AIT), continuous (MCT) and control (CG). All patients will be evaluated with~     microneurography, peripheral muscle perfusion, muscle biopsy, blood samples, accelerometer,~     cardiopulmonary exercise test and quality of life before and after end of the period of 03~     (three) months.~   "
85482|NCT02448134|"~     This project evaluates a combination of policy and social influence interventions to reduce~     adolescent alcohol use and its sequelae.~   "
85483|NCT02448121|"~     The purpose of this study is to evaluate the safety and efficacy of autologous bone marrow~     stem cells in sickle cell disease patients with osteonecrosis~   "
85484|NCT02448108|"~     The investigators will conduct a small pilot study to test the feasibility and acceptability~     of treating bipolar disorder (BP) in primary care with online psychotherapy delivered both~     with and without telephone, text, and email support from a clinical helper (CH). The ultimate~     goal of this work is to provide preliminary data needed to design a larger scale~     effectiveness study of online psychotherapy for treating BP in primary care.~   "
85485|NCT02448095|"~     This observational study aims at assessing the tolerability and safety profiles of Ponatinib,~     a drug used for Chronic Myeloid Leukemia patients who are Philadelphia positive. This drug is~     used during the chronic phase of the disease, according to the Italian national compassionate~     law 648/96.~   "
85504|NCT02447848|"~     To evaluate the safety and efficacy of sufentanil tablet (ST) 30 mcg in the management of~     moderate-to-severe acute pain in patients in an emergency room (ER) setting.~   "
85486|NCT02448082|"~     Dandruff, also known as Pityriasis capitis, is a common condition which affects the scalp of~     almost half the post-pubertal population regardless of race and gender. It is said that~     dandruff affects at least 50% of the world's adult population and about 15 - 20% of the~     world's total population. Dandruff is usually marked by flaking as well as itching and~     irritation of the scalp which can also lead to greasiness. Dandruff can lead to physiological~     and psychological issues and can be very distressing and embarrassing for the sufferer,~     causing low self esteem and social problems. Current treatment options for dandruff include~     many over-the-counter preparations, anti-dandruff shampoos and topical steroid applications~     which are accompanied by numerous adverse effects. According to Lunar Pharmaceuticals~     Ichthyol® Pale is a sodium salt of pale sulphonated shale oil in aqueous solution with~     anti-microbial properties which can combat dandruff helping with the causative and~     symptomatic relief of this condition.~      The aim of the study is to determine the efficacy of Sodium Shale Oil Sulponate 1% shampoo in~     the treatment of Pityriasis capitis. This will be evaluated using the Adherent Scalp Flaking~     Score (ASFS) grading and the Visual Analogue Scale (VAS).~   "
85487|NCT02448069|"~     Background:~      Our prior work with combination argatroban + recombinant tissue plasminogen activator (rt-PA)~     (ARTSS-1: Phase IIa low-dose safety study; n=65 and ARTSS-2: Phase IIb randomized low and~     high-dose study; n=90), demonstrated safety of the two drugs when delivered concomitantly and~     recanalization rates were greater than with historical controls. Further, interim analysis of~     neurological outcomes at 75 patients of the randomized Phase IIb trial, demonstrated a signal~     of efficacy when compared to control (rt-PA alone) patients. However, rt-PA fails to~     reperfuse brain in most patients with large thrombi, prompting several recent randomized~     clinical trials which have demonstrated that intra-arterial therapy (IA) following rt-PA~     substantially improves outcome in patients with distal carotid or proximal middle cerebral~     artery occlusions. As a result, rt-PA + IA has become the new standard-of-care for many~     patients with large arterial occlusions such as those treated in ARTSS-1 and 2. Therefore,~     this study is necessary to explore the feasibility and safety of adding Argatroban in acute~     ischemic stroke patients who also receive rt-PA followed by IA.~      Primary Objective:~      To demonstrate the feasibility and safety of treating stroke patients with Argatroban who~     undergo usual thrombolysis care (intravenous rt-PA followed by IA).~      Secondary Objectives:~        1. Assess rates of ultra-early recanalization at commencement of IA;~        2. Assess the completeness and pattern of reperfusion as obtained by IA; 3) Assess clinical~          outcome~   "
85488|NCT02448056|"~     Hepatocellular carcinoma (HCC) is the most common primary liver cancer and the third leading~     cause of cancer-related death worldwide. Treatments of HCC include surgical resection, local~     therapies such as radiofrequency ablation and ethanol injection, transarterial~     chemoembolization, sorafenib and best supportive care. However, even after successful~     treatment such as surgical resection, most patients suffered from recurrence or progression~     of the tumor. Because clinical staging systems cannot precisely predict the outcome of~     patients with HCC, it's of great interest to search serum biomarkers for HCC. Among them,~     alpha-fetoprotein (AFP) is the most well-studied. However, the applicability of AFP for HCC~     after surgical resection of tumor or after local therapy is still uncertain.~      MicroRNAs (miRNAs), 17- to 25-nucleotide non-coding RNAs, are frequently dysregulated in~     cancer and emerging as novel non-invasive biomarker for cancer screening, diagnosis, monitor~     therapy efficacy and predict prognosis. MiRNAs are stably expression in serum as their~     resistance to endogenous RNase and easily storage with high stability. Several studies have~     shown abnormal expression of human serum miRNAs in many cancers such as liver, colorectal,~     and pancreatic cancer. The sensitivity of miRNA as a diagnostic biomarker of HCC could be~     upto 80%. Using miRNA arrays can generate miRNA signatures and improve the sensitivity and~     specificity of biomarker for tumor diagnosis and prognosis prediction.~      In this study, the investigators will establish an miRNA platform as biomarkers for~     diagnostic or prognostic tools of HCC. The investigators will also compare the miRNA~     expression level before and after treatment in the serum and correlate the miRNA expression~     between serum and tumor tissue.~   "
85489|NCT02448043|"~     Topical prostaglandin agents are used to help reduce eye pressure in glaucoma patients.~     Bimatoprost (Lumigan 0.01%) is such an agent (Allergan, Inc.). Several of our patients on~     bimatoprost and an observational study of patients on bimatoprost in another center reported~     that fingernails grew longer and became less brittle using the topical eye drops to the eyes.~     The purpose of the double-blinded study is to determine whether the application of the eye~     drops directly to the proximal nail fold of one hand using the opposite hand as a control~     will result in longer nails, less brittle nails, and reduced eye pressures should any of the~     medication be absorbed into the systemic circulation.~   "
85490|NCT02448030|"~     Cardiovascular exercise adjustments are required during in order to redistribute blood flow~     from non-exercising vascular areas to active muscles. This hemodynamic adjustments, which are~     partially mediated by mechanosensitive and metabosensitive reflexes, ultimately increase~     oxygen and nutrient delivery to exercising muscle tissues (Mitchell, 1990). Static handgrip~     exercise has been shown to induce alterations in the arterial baroreflex function (Kim, 2005)~     and activation of muscle metaboreflex that increases arterial blood pressure and peripheral~     vasoconstriction, respectively. Functional electrical stimulation (FES) treatment used in~     physical therapy in patients who are unable to tolerate conventional exercise showed to be a~     good alternative for muscle strengthening (Sbruzzi, 2010) and to improve metabolic~     abnormalities (Karavidas, 2006). However, the effect of FES on metaboreflex activation in~     healthy individuals has never been investigated. Therefore, this study aims to evaluate the~     metaboreflex activation induced by FES in upper and low limbs in healthy individuals, and~     also to compare their results with the effects caused by isometric exercise.~   "
85491|NCT02448017|"~     Herbst appliance is one of the most popular fixed functional appliances to treat orthodontic~     patients with small lower jaws. Since small lower jaws are reported to be one of the main~     reasons to induce sleep disordered breathing(SDB) of children, Herbst appliance can be used~     to treat SDB children. Previously no study compared the effects of Herbst appliance therapy~     with removable functional appliance on airway dimension, so it still remains unclear which~     kinds of functional appliance is more suitable for improving airway dimension. This study~     will assess the effect of Herbst appliance on airway dimension and compare the effects with~     those of twin block appliance (a popular 24 hours used removable functional appliance, and~     also commonly used to treat adult sleep apnea).~   "
85493|NCT02447991|"~     Suffering from dizzy spells and migraine headaches?~      Vestibular Migraine (VM), a newly recognized type of migraine that causes bouts of dizziness.~      University of California, Los Angeles (UCLA) and The Mayo Clinic is seeking people with VM to~     participate in a research study. The purpose of this study is to look at the natural history~     of VM and learn more about common symptoms. Investigators also want to learn the effects,~     both positive and negative, of the commonly used migraine drug, rizatriptan, when it is used~     for spells of dizziness in people with VM.~      Patients may be eligible to participate if:~        -  Patients are between the ages of 18 & 65~        -  Patients have a history of vestibular migraine~        -  Patients are able to maintain a vestibular symptom diary~      The study includes 3 visits with compensation. All participants must complete questionnaires~     on dizziness, headache symptoms, general health and well-being, mental health, and a~     questionnaire on patient's satisfaction with study medication.~   "
85494|NCT02447978|"~     The purpose of this study is to assess duration of protection for GSK DTaP vaccines in~     preventing pertussis.~   "
85495|NCT02447965|"~     The purpose of this study is to show that the use of preoperative rectus sheath blocks can~     ultimately alleviate the need for using nondepolarizing muscle relaxants during certain~     abdominal procedures.~   "
85496|NCT02447952|"~     Study 201283 is an exploratory, non-controlled, non-drug study in Amyotrophic Lateral~     Sclerosis (ALS) subjects. This study is being conducted as the first step for developing new~     meaningful measure(s) which might prove to be more effective than existing measures for~     monitoring clinical function and disease course in ALS. The objective of this study is to~     test novel measures of movement/physical activity, heart rate and speech and explore how they~     measure disease progression by evaluating their relationship to gold standard measures of~     function. This study will be conducted in two phases. A variable length Pilot Phase to test~     biotelemetry instruments and algorithms reliability and ease of use/acceptance. Approximately~     5 subjects will have at least 1 clinic visit to perform a series of set reference tasks while~     wearing the accelerometer and electrode. Subjects will also continuously wear the~     accelerometer and electrode in their routine home-life setting for approximately 3 days after~     the clinic visit (i.e., home monitoring). Subjects in the Pilot Phase will continue in the~     study and participate in the Core Study Phase. A 48 week Core Study Phase will be conducted~     to evaluate how measures of movement/physical activity, speech and Heart Rate Variability~     (HRV) relate to ALS disease progression. During this phase, a maximum of 25 subjects will be~     enrolled. Subjects will attend 5 clinic visits to perform gold standard measures of function~     and perform a series of set reference tasks while wearing the accelerometer and electrode. In~     between clinic visits, every month subjects will attach the accelerometer and electrode and~     wear it for approximately 3 days in their home. A telephone contact with the subject will be~     made by the site at the end of each 3-day home monitoring period.~      All third party trademark rights are the rights of their respective owners.~   "
85497|NCT02447939|"~     Present clinical study will be conducted in China to evaluate the pharmacokinetics (PK) of~     single and repeat oral doses of dabrafenib alone and dabrafenib and trametinib in~     combination, the safety profile and the clinical activity of dabrafenib in combination with~     trametinib in Chinese melanoma subjects with BRAF V600E/K mutation. Approximately 20~     evaluable subjects will be enrolled in the study, out of which, the first 10 subjects will be~     enrolled into cohort A (Part I and II) and remaining 10 subjects will be enrolled in cohort~     B. Subjects in cohort A (Part I) will receive dabrafenib 150 mg twice daily (BID) and~     subjects in cohort A (Part II) and Cohort B will receive combination of dabrafenib 150 mg BID~     and trametinib 2 mg once daily (QD). Study treatment will continue until disease progression,~     death or unacceptable toxicity. After disease progression, all enrolled subjects will be~     followed up for overall survival. The study will be completed after all subjects have died or~     surviving subjects have had at least 5 years of follow-up, whichever occurs first.~   "
85498|NCT02447926|"~     Regulatory CD4+CD25+ T cells (Treg) derived from the thymus and/or periphery can control~     immune responsiveness to auto- and allo-antigens. However, there have been few efforts to~     harness the therapeutic potential of isolated Tregs to control graft rejection and inducing~     transplantation tolerance in solid organ recipients. In order for Tregs to be used as a~     clinical treatment, the following properties are necessary: ex vivo generation of sufficient~     numbers of cells, migration in vivo to sites of antigenic reactivity, ability to suppress~     rejection in an alloantigen-specific manner, and survival/expansion after infusion. The and~     others have demonstrated 1) the feasibility of expanding Treg ex vivo, 2) the ability of~     these cells to down-regulate allogeneic immune responses in vitro, and 3) the efficacy of~     Treg for prevention of allograft rejection in animal models. In kidney transplant, the~     investigators have developed strategies for the ex vivo expansion of naturally occurring~     human Tregs (nTregs) from leukapheresis products that would allow for the clinical employment~     of this cellular therapy. The investigators are also interested in this approach in patients~     with end stage liver disease (ESLD) undergoing liver transplantation (LT). Our central~     hypothesis is that alloreactive human nTreg with suppressive action can be expanded ex vivo~     from ESLD patients (this proposal) and used to both prevent liver transplant rejection and~     facilitate the minimization and withdrawal of drug-based immunosuppression (future~     proposals). This application will further define and validate efficient methods for ex vivo~     expansion of human CD4+CD25+CD127- FOXP3+nTregs cells in ESLD. The investigators herein~     propose to use leukapheresis products obtained from patients with ESLD to further refine and~     optimize protocols for expansion of Tregs. Suppressive function of expanded cells will be~     assessed using in vitro assays of alloreactivity (mixed lymphocyte culture).~   "
85499|NCT02447913|"~     The proposed project will help in assessing the effectiveness of a demand-side financing~     project that provides family planning services bundled in a package of postnatal care and~     infant immunization services. This approach will use postnatal and infant health as a gateway~     to family planning - building confidence among the client and her influencers in the provider~     and repositioning family planning as part of a continuum of care to ensure the health of the~     mother and the infant. Vouchers will help in creating demand among poor women for the Family~     planning and child immunization. Also incentivizing providers against each voucher will help~     in improving their counselling skills as they will spend more time with voucher clients~     resulting is a satisfied client and better compliance with Family planning methods.~   "
85500|NCT02447900|"~     Proof of concept study evaluating safety and performance of a gel marker (BioXmark) used for~     image guidance in deep inspiration breathhold radiotherapy (DIBH IGRT) in patients with~     locally advanced non-small cell lung cancer (NSCLC)~   "
85501|NCT02447887|"~     This is a Phase I/II trial of the combination pegylated IFN-alpha 2b with ixazomib in~     metastatic renal cell carcinoma (mRCC). Researchers believe that by disabling the protein~     complex NF-kB, which controls the transfer of genetic information; using the study drug~     Ixazomib, they can promote necrotic cell death of RCC using interferon alpha - 2b. They~     hypothesize that the combination of ixazomib with IFN will lead to increased necrotic cell~     death in RCC tumors and consequent clinical benefit to patients.~      Patients will receive ixazomib capsules and pegylated IFN alfa 2b injection in this research~     study. Treatments will be given weekly and 4 weeks of treatment make up one cycle.~   "
85502|NCT02447874|"~     The purpose of this study is to determine whether giving extra arginine to patients with~     sickle cell disease seeking treatment for vaso-occlusive painful events (VOE) will decrease~     pain scores, decrease need for pain medications or decrease length of hospital stay or~     emergency department visit.~   "
85505|NCT02447835|"~     Within the past 20 years, there has been a striking increase in the incidence of obesity 1;2,~     type 2 diabetes mellitus (T2DM) 3-5, and cardiovascular diseases (CVD) in the schizophrenic~     population 6-8 . Large NIH-funded trials indicate that the prevalence of metabolic syndrome~     is twice to three times greater in schizophrenic patients on a specific class of drug termed~     the atypical antipsychotics (AAPs), of which olanzapine is an example, as compared to~     matched controls 8. Identification of the pathophysiological mechanisms contributing to~     metabolic disease in schizophrenic patients on AAPs has been hampered by the inability to~     differentiate underlying disease from treatment-emergent complications. In addition, despite~     falling within the same drug class, different AAPs exhibit differential associations with~     metabolic disease. Olanzapine is one of the AAPs associated with the greatest weight gain and~     degree of metabolic impairments.~   "
85506|NCT02447822|"~     This is a prospective randomized controlled study to evaluate feasibility and safety of early~     steroid withdrawal after 6mg/kg vs 4.5mg/kg Thymoglobulin induction therapy in kidney~     transplantation. Patients are enrolled from June, 2015 for 24 months. They are randomized to~     either 6mg/kg or 4.5mg/kg Thymoglobulin induction group. Steroid withdrawal is done within~     one week after kidney transplantation for all the patients. Maintenance immunosuppressants~     are Tacrolimus and Mycophenolate mofetil (or Myfortic). Primary outcome is a composite of~     biopsy-proven acute rejection, delayed graft function, graft loss or death within one year~     post transplant.~   "
85507|NCT02447809|"~     Clopidogrel is an important anti-platelet agent.However, about 30% of the coronary artery~     disease patients presented clopidogrel low response (CLR).Previous studies showed that the~     cardiovascular event ratio of the CLR patients was 4.4 times of the normal responders.~      It is known that the plasma and platelet miRNAs are determined by different disease status~     when platelets are released from the megakaryocyte, and the platelet miRNAs can adjust the~     expressions of the platelet's receptors and proteins.The purpose of this study is to find~     multiple platelet miRNAs involved in the development of CLR, and platelet miRNAs cause CLR~     through adjusting the expressions of the key receptors and proteins in the ADP activating~     pathway and consequently reducing their responses to clopidogrel.~      The CLR will be detected by light transmission aggregometry (LTA) and vasodilator-stimulated~     phosphoprotein phosphorylation (VASP-P). Differential expressions of plasma and platelet~     miRNAs profile in CLR patients will be screened by deep sequencing and validated to~     investigate the association between plasma and platelet miRNAs profile and CLR as well as the~     patients' prognosis.The study results would serve as markers for individualized anti-platelet~     treatment, and supply new targets for the treatment of coronary artery disease.~   "
85508|NCT02447796|"~     The investigators designed a prospective randomized study to compare the conventionally used~     sedative drug propofol with a latest alternative dexmedetomidine (DEX), in patients with~     end-stage renal disease undergoing arteriovenous fistula (AVF) surgery.~   "
85509|NCT02447783|"~     Flavanols are plant-derived compounds commonly present in the human diet. Examples of~     flavanol-containing foods and beverages are apples, chocolate, tea, wine, berries,~     pomegranate and nuts. The consumption of flavanol-containing foods and beverages has been~     associated with improvements in cardiovascular health. In this study, the investigators hope~     to learn more about the effects of long term consumptions of cocoa flavanols on blood~     pressure, platelet function and other metabolic parameters in healthy humans. This study is a~     continuation of a previous study investigating the consumptions of increasing amounts of~     cocoa flavanols on blood pressure, platelet function and other metabolic parameters in~     healthy humans~   "
85510|NCT02447770|"~     Flavanols are plant-derived compounds commonly present in the human diet. Examples of~     flavanol-containing foods and beverages are apples, chocolate, tea, wine, berries,~     pomegranate and nuts. The consumption of flavanol-containing foods and beverages has been~     associated with improvements in cardiovascular health. In this study, the investigators hope~     to learn more about the effects of the consumption of increasing amounts of cocoa flavanols~     on blood pressure, platelet function and other metabolic parameters in healthy humans. This~     study was followed by a second study that aimed at investigating the effects of long term~     consumptions of cocoa flavanols on blood pressure, platelet function and other metabolic~     parameters in healthy humans.~   "
85511|NCT02447757|"~     Retrospective observational study to determine the efficacy of remifentanil during the~     delivery. Authors will search the data in period between 2010 and 2014 in cohort of 100~     parturients and obtain data of analgesic efficacy (VAS score after remifentanil analgesia~     induction) and parturients satisfaction with the method.~   "
85512|NCT02447744|"~     Childhood maltreatment is remarkably prevalent, and it has been shown to be associated with a~     wide spectrum of mental health problems, and it also been shown to be associated with smaller~     hippocampal volumes. This trial aims to see whether the 8-week mindfulness based stress~     reduction intervention can reduce the symptoms of depression, anxiety and PTSD for young~     adults with childhood maltreatment, and whether it can increase the hippocampal volumes.~   "
85513|NCT02447731|"~     Study of the effects of sonic pressure oscillations on pulmonary gas exchange with added dead~     space.~   "
85514|NCT02447718|"~     This multi-center open label clinical trial aims to identify predictors of low antibody~     titers to vaccine antigens in children with ALL who completed chemotherapy in the prior 6~     months, and to determine the immunogenicity and safety of diphtheria-tetanus-acellular~     pertussis-inactivated poliomyelitis-Haemophilus influenzae type b (DTaP-IPV-Hib) and~     13-valent pneumococcal conjugate vaccine (PCV13) booster immunization administered 6 months~     post-chemotherapy, followed by 23-valent pneumococcal polysaccharide vaccination (PPV23) 2~     months later. The results will support the development of clinical practice guidelines for~     this population.~   "
85515|NCT02447705|"~     Nephrotoxicity is one of the adverse effects of lamivudine and dosage of lamivudine has to be~     reduced if patients' renal function is insufficiency. Telbivudine may improve glomerular~     filtration rate. This study is to see whether renal function is improved when Lamivudine is~     replaced by telbivudine in liver transplantation patients.~   "
85516|NCT02447692|"~     For adult patients with acute respiratory failure requiring invasive mechanical ventilation,~     does a ventilation strategy using proportional assist ventilation with load-adjustable gain~     factors (PAV+) result in a shorter duration of time spent on mechanical ventilation than a~     ventilation strategy using pressure support ventilation (PSV)?~   "
85518|NCT02447666|"~     Indication Treatment of pediatric subjects with newly diagnosed advanced myelodysplastic~     syndrome (MDS) or juvenile myelomonocytic leukemia (JMML) prior to hematopoietic stem cell~     transplantation (HSCT).~      Objectives Primary Objective The primary objective is to assess the treatment effect on~     response rate (MDS: either complete remission [CR], partial remission [PR], or marrow CR;~     JMML: either clinical complete remission [cCR] or clinical partial remission [cPR]); at Cycle~     3 Day 28 (each cycle is 28 days) and to compare against standard therapy using a~     matched-pairs analysis of historical data.~      Secondary Objective The secondary objective is to further evaluate safety, efficacy,~     pharmacokinetics (PK), and pharmacodynamics (PD) of azacitidine in this subject population.~      Study Design This is a prospective, open-label, Phase 2 study consisting of 2 parallel~     experimental arms, one for each disease group: MDS and JMML. Each arm is designed based on~     Simon's Optimal 2 stage study design. The sample size has been calculated to allow evaluation~     of the response rate at 28 day-Cycle 3 Day 28 in each of the 2 disease groups. Each of the~     experimental arms will also individually be compared against a historical control arm using~     data retrospectively collected from the European Working Group of MDS in childhood (EWOG-MDS)~     registry by means of a matched-pairs analysis; matched for predefined subject baseline~     characteristics defined before any results from this study are known post Stage 1.~      Twenty subjects with MDS and 35 JMML subjects evaluable for the primary endpoint (ie,~     subjects that receive at least 1 dose of investigational product [IP]) will be enrolled at~     approximately 45 centers in Europe. Each experimental arm has 1 interim analysis planned (at~     the end of Stage 1). If, during Stage 1 evaluation, less than 2 subjects are observed with a~     CR, PR, or marrow CR after 3 months of azacitidine in the first 9 subjects with MDS, then~     enrollment will be stopped. Similarly, if less than 3 subjects are observed with a cPR or cCR~     after 3 months of azacitidine in the first 18 subjects with JMML, then enrollment will be~     stopped.~   "
85519|NCT02447653|"~     The study design comprises a randomized trial of patients undergoing primary total hip~     arthroplasty using the G7 acetabular system and Taperloc Complete stem comparing regular~     plasma porous spray with HA coating using Bonemaster (BM) in an uncemented cup. DEXA scanning~     will be used to measure periprosthetic bone mineral density. Clinical evaluations will be~     conducted .~   "
85520|NCT02447640|"~     This is an open label study, non-randomized, positron emission tomography (PET)study~     investigating mGlu5 receptor occupancy after single or two oral dosing of ADX48621 in healthy~     subjects using [18F]-FPEB as the radiotracer.~   "
85521|NCT02447627|"~     The purpose of the study is to determine whether imaging techniques, such as magnetic~     resonance imaging (MRI), near infrared spectroscopy (NIRS), laser speckle contrast imaging~     (LSCI), and optical imaging (OI), can detect differences in blood flow and oxygen levels in~     different organ systems of participants with sickle cell disease (SCD). Differences in blood~     flow and oxygen levels detected by these techniques will be evaluated to determine their~     utility as biomarkers of clinical disease pathophysiology.~   "
85522|NCT02447614|"~     The study is designed to investigate the natural course of Primary snoring in 1-2 years or~     more and the different effect of drug and surgical treatment applied in children with~     obstructive sleep apnea (OSAS) by comparing the polysomnography(PSG) and sleep questionaires~     in 6 months after treatment.~   "
85523|NCT02447601|"~     To assess the effect of PEX168 doses on the pharmacokinetics of simvastatin(as determined by~     simvastation acid) in healthy subjects.~      To assess the safety of single doses of simvastation administered with and without PEX168~   "
85524|NCT02447588|"~     Intrauterine insemination (IUI) combined with ovarian stimulation protocols has become one of~     the first alternative treatment against infertility, although results in gestational terms~     are highly variable, ranging between 10% and 25%. The influence of progesterone levels in~     stimulated cycles of intrauterine insemination is an aspect little studied; however, this~     information may be useful when synchronizing the time of insemination with the implantation~     window, as it has been observed that patients with elevated levels of progesterone in the~     follicular phase exhibit a significant decrease in ongoing pregnancy rates, these results~     being possible due to premature ovulation which causes asynchrony between the embryo and the~     endometrium.~      Taking into account these considerations, the aim of the investigators' study is to determine~     the effectiveness, in terms of ongoing pregnancy rates, to advance the intrauterine~     insemination with sperm donor (24 hours post-hCG) with respect to the standard schedule (36~     hours post-hCG) according progesterone levels determined the day of hCG administration~   "
85525|NCT02447575|"~     Metered Dose Inhaler (MDI) and Dry Powdered Inhaler (DPI) are the two most common devices~     used to deliver medicine in conditions such as asthma and chronic obstructive pulmonary~     disease. It is well-known that most patients do not use correct technique when using a~     metered dose inhaler. This leads to poor control of their disease. This study is being done~     so the investigators can record the patient using the metered dose inhaler before and after a~     short teaching session. This information will be fed into an invitro system (device) to allow~     the researchers to study the effect of error on drug delivery. The device being used is the~     Rice R3 electronic flowmeter.~   "
85526|NCT02447562|"~     Controlled and Randomized Clinical trial with 3 parallel groups (intervention group with a~     health platform NOMHADchronic, phone-based care group, usual care group) developed in the~     Valencia La Fe Health Department. 495 high-complexity chronic patients will be included~     according to a combined recruitment based on a risk predictive model plus clinical opinion.~     Patients will be followed-up during 12 months in order to evaluate health-related quality of~     life, mortality, health consumption, health direct cost and treatment satisfaction.~   "
85527|NCT02447549|"~     Bladder cancer is the seventh most common cancer in the UK, with 10,399 new cases diagnosed~     in 2011. In a quarter of these cases the cancer has infiltrated the muscular wall of the~     bladder (muscle invasive) and is life threatening. This type of bladder cancer is usually~     treated either with surgical removal of the bladder, or daily radiotherapy treatment (high~     strength xrays which kill cells), given every day for 4 or 7 weeks. RAIDER will investigate~     methods which have the potential to improve how well this radiotherapy works.~      RAIDER is based on a study of novel radiotherapy techniques which was conducted at a single~     UK NHS Trust. Bladder radiotherapy is normally delivered using a single plan throughout~     treatment and treats the whole bladder with the same radiotherapy dose. In adaptive~     radiotherapy the delivery plan is chosen from 3 possible plans. In cancer (tumour) focused~     radiotherapy, the highest dose of the radiotherapy is aimed at the tumour within the bladder.~      In RAIDER, 240 participants with muscle invasive bladder cancer will be in one of 3 treatment~     groups:~        1. standard whole bladder radiotherapy~        2. standard dose tumour focused adaptive radiotherapy~        3. dose escalated tumour boost adaptive radiotherapy~      Participants will visit the hospital 4 weeks, 3, 6, 9, 12, 18 and 24 months after~     radiotherapy and annually thereafter to check whether the cancer has returned and to receive~     treatment for any symptoms they may be experiencing.~      RAIDER aims to confirm in a multicentre setting that novel techniques allow a higher~     radiotherapy dose than standard to be reliably targeted at the tumour within the bladder and~     to check that the long term side effects of the treatment are acceptable. If this is the~     case, results of RAIDER will be used to develop a study to establish whether dose escalated~     radiotherapy is better at treating bladder cancer than standard dose.~   "
85528|NCT02447536|"~     The investigators aim to conduct a randomised controlled trial comparing two Bacille~     Calmette-Guérin (BCG) strains currently used in Guinea-Bissau, the Danish and the Russian, in~     terms of prevention of neonatal and early life morbidity and mortality, immune responses and~     adverse events related to BCG vaccination. The primary outcome will be hospital admissions~     within 6 weeks of age.~   "
85529|NCT02447523|"~     Worldwide, the rising incidence of obesity has led to the identification of an obesity~     related syndrome, called metabolic. This syndrome is characterized by central obesity,~     hypertension, insulin resistance and altered lipid levels.~      Taking into consideration the rising incidence of obesity, anesthetists will more frequently~     encounter patients with metabolic syndrome, in their everyday practice. Moreover, the~     comorbidities that are related to the metabolic syndrome, increase the risk for perioperative~     complications. Therefore, strategies that will evaluate and modify the risk will be of great~     importance in the management of these patients, in order to maximize peri-anaesthetic and~     surgical safety.~      The aim of the study is to assess the incidence of metabolic syndrome and the impact of its~     presence on the outcome of patients undergoing elective laparotomy.~   "
85530|NCT02447510|"~     Background: platelet concentrate could enhance growth factors (GF) crevicular fluid levels~     which might be crucial to proper tissue repair and wound healing. However, the open usually~     contaminated nature of periodontal defects could affect negatively GF availability and~     activity. To test this assumption, this study was designed to evaluate levels of VEGF and~     PDGF-BB in gingival crevicular fluid (GCF) during the early stages of healing of localized~     intrabony defects treated with platelet rich in growth factor (PRGF) and platelet rich fibrin~     (PRF) as compared with xenograft defect filling control.~      Methods: Thirty non-smoking patients with severe chronic periodontitis participated in this~     prospective, randomized and single blinded trial. Each patient contributed one interproximal~     defect that was randomly assigned to the bone substitute grafting control (n=10) G1,~     experimental PRGF (n=10) G2 and PRF (n=10) G3. Plaque index, gingival index, probing depth~     (PD), clinical attachment level (CAL) and the intrabony depth of the defect (IBD) were~     measured at baseline for patient enrollment. Gingival crevicular fluid (GCF) samples were~     collected on days 1 and 3, 7, 14, 21, and 30 days after therapy. The primary outcome variable~     was the change in VEGF and PDGF-BB levels for sites treated by PRGF and PRF compared to that~     of the xenograft treated cases.~   "
85531|NCT02447497|"~     The objective of the study is to demonstrate persistence of the CHG/IPA Prep on skin flora of~     the abdominal and inguinal regions of human subject.~   "
85532|NCT02447484|"~     The purpose of this study is to determine whether a program of regular, theory-based text~     messages that encourages the message recipient to continue practicing safer sex (i.e., using~     condoms with sex partners) is effective in maintaining positive behavior change in women who~     have completed a brief safer-sex training.~   "
85533|NCT02447471|"~     Currently, BP is measured using an inflatable cuff wrapped around the patient's upper arm.~     This can be set to inflate every minute, but measurement may fail due to patient movement or~     shivering. Failed measurement occurs in up to 38% of patients.~      This study aims to determine how the Nexfin device - which measures BP using a cuff wrapped~     around a finger - compares to standard BP measurement.~   "
85534|NCT02447458|"~     The purpose of this study was to evaluate the safety, tolerability, and pharmacokinetics of~     MLN3126 when administered as a single dose of tablets at escalating dose levels in healthy~     participants.~   "
85535|NCT02447445|"~     Hand grip strength (GS) is a non-invasive marker of whole body skeletal muscle strength and~     function used in research and recommended as a simple inexpensive measure suitable for~     clinical use. Research has shown that low GS in hospital inpatients is associated with poor~     healthcare outcomes including increased postoperative complications, longer length of stay,~     increased functional limitations and disability. Measuring GS on admission to hospital has~     the potential to identify people at risk of poor healthcare outcomes allowing early~     intervention including focus on nutrition and mobility. Yet, GS measurement is not routinely~     used in clinical practice. The aim of this study is to evaluate the implementation of GS~     measurement into routine clinical practice in Medicine for Older People wards at UHS.~   "
85536|NCT02447432|"~     The primary aim of the study is to demonstrate that an investigational 4-dose presentation of~     the 10Pn-PD-DiT vaccine with preservative is non-inferior to the licensed presentation of~     Synflorix (preservative-free) in terms of immune responses to the 10 vaccine pneumococcal~     serotypes (primary objective) and to the vaccine-related pneumococcal serotype 19A (first~     secondary objective), after administration of a 3-dose primary vaccination course at 6, 10~     and 18 weeks of age co-administered with the first 2 doses of DTPw-HBV/Hib vaccine given at~     6, 10 and 14 weeks of age (according to the Expanded Program on Immunization (EPI) schedule).~      In addition, the study will also assess the safety, reactogenicity, immunogenicity and~     antibody persistence (approximately 7 months following primary vaccination) of the 4-dose~     presentation of the 10Pn-PD-DiT vaccine given as primary vaccination schedule at 6, 10 and 18~     weeks of age followed by a booster dose at 38 weeks.~      This study also aims at assessing the safety, reactogenicity and immunogenicity of the 4-dose~     presentation of the 10Pn-PD-DiT vaccine when given as a booster dose at approximately 9~     months of age.~   "
85537|NCT02447419|"~     This study is a single-arm,phase II study of gefitinib in patient with epidermal growth~     factor receptor amplification Refractory solid tumors.~      Gefitinib 250 mg will be administered orally daily.~      To investigate the efficacy and safety of gefitinib in patient with epidermal growth factor~     receptor amplification Refractory solid tumors.~   "
85538|NCT02447406|"~     Phase Ib/II, single-arm study of AZD6094 (Volitinib) in combination with docetaxel, in~     advanced gastric adenocarcinoma patients with MET amplification as a second-line treatment.~      Phase Ib:Investigational product, dosage and mode of administration Volitinib is an orally~     available, potent, selective, small molecule c-MET inhibitor.~      Volitinib should be administered at least 200mg orally once a day in 21 days for achieving~     appropriate antitumor activity.~      Docetaxel 60 mg/m2 will be administered via intravenous access once every 3 weeks Phase II:~     Investigational product, dosage and mode of administration Volitinib is an orally available,~     potent, selective, small molecule c-MET inhibitor. Subjects will receive Volitinib once daily~     ( at the MTD determined from Phase Ib) for 21 days as one cycle.~      Docetaxel 60 mg/m2 will be administered via intravenous access once every 3 weeks.~   "
85539|NCT02447393|"~     This is a single center, single blind, single dose, randomized, partial cross-over study to~     confirm bioequivalence between levocetirizine and cetirizine.~   "
85665|NCT02445742|"~     Prospective, open label, multicenter, phase II study evaluating correlation of SNPs with~     efficacy and toxicity in patients treated with Bosutinib. A total of 50 patients with~     previously treated Ph+ chronic phase CML will be included in the study~   "
85540|NCT02447380|"~     Phase II, single-arm study of AZD6094 (Volitinib) in combination with docetaxel, in advanced~     gastric adenocarcinoma patients with MET overexpression as a second-line treatment.~      Volitinib is an orally available, potent, selective, small molecule c-MET inhibitor.~      Subjects will receive Volitinib once daily (at the MTD determined from Phase Ib) for 21 days~     as one cycle.~      Docetaxel 60 mg/m2 will be administered via intravenous access once every 3 weeks.~      To investigate the efficacy of volitinib when given in combination with docetaxel in patients~     with advanced gastric adenocarcinoma harboring MET overexpression.~   "
85541|NCT02447367|"~     The purpose of this study is to investigate the pharmacokinetic drug interaction between~     Solifenacin and Tamsulosin in healthy male volunteers.~   "
85542|NCT02447341|"~     This is a national, multicenter, cross-sectional, observational study within a convenience~     sample of Internal Medicine departments from 100 hospitals in Spain which agree to~     participate in the study. This study will be a cross-sectional chart review which will~     require the collection of data from medical records and from face-to-face interviews~     conducted during the inclusion visit. Physician interviews are needed to collect three~     variables of interest, recommended by the Spanish Society of Internal Medicine as necessary~     data about profile and management of NVAF patients: cognitive deterioration based on the~     patient's responses, physician's assessment of the patient's life expectancy, and physician's~     opinion of the antithrombotic treatment previously prescribed. The investigators will only~     provide their opinion on previously prescribed therapies (i.e. prescribed before F2F).~     Hospitals to be contacted for the study include those known to participate in observational~     studies in Spain; the hospitals will therefore not be a random sample of Spanish hospitals.~   "
85543|NCT02447328|"~     This single-arm study aims to assess the safety and tolerability profile of~     Fulvestrant(Faslodex®) as 2nd line and later therapy in postmenopausal women with locally~     advanced or metastatic breast cancer. The primary objective is to evaluate the adverse events~     after Fulvestrant (Faslodex®) for about 6 months~   "
85544|NCT02447315|"~     The purpose of this study is to evaluate the pharmacodynamic effect of oral doses of~     pilocarpine on salivary secretion in healthy male and female subjects. In addition,~     pharmacodynamic effect on static pupillometry will be evaluated as well as pharmacokinetics~     and safety and tolerability of oral doses of pilocarpine in healthy subjects.~   "
85545|NCT02447302|"~     The purpose of this study is to determine whether Etrasimod (APD334) is a safe and effective~     treatment for ulcerative colitis.~   "
85546|NCT02447289|"~     Randomised clinical trial to test the efficacy, safety and cost-effectiveness of sedatives;~     masked, controlled, parallel design with three arms, phase 4.~   "
85547|NCT02447276|"~     The primary objective of this study is to evaluate the effectiveness of REGN475 compared to~     placebo in participants with pain due to osteoarthritis (OA) of the knee or hip and a history~     of inadequate joint pain relief or intolerance to current analgesic therapy.~   "
85548|NCT02447263|"~     The purpose of this study is to evaluate the safety and efficacy of HepaSphere interventional~     therapy using digital subtraction angiography（DSA） for liver cancer.~   "
85549|NCT02447250|"~     The purpose of this study is to help determine the best dose of albuterol in premature babies~     at risk of developing bronchopulmonary dysplasia (BPD). BPD is the chronic lung disease of~     prematurity and is associated with increased morbidity and mortality, longer hospital stays,~     and increased healthcare utilization. Albuterol is an inhaled medication frequently used in~     premature infants with chronic lung disease and in people with asthma. It is believed to be~     safe, but the optimal dose for infants is not clear. The investigators hypothesize that~     albuterol may help a subset of premature infants with lung disease, but they need to~     determine the best dose prior to doing research about how effective it is for chronic lung~     disease/BPD. Response to each of three doses of albuterol will be measure using pulmonary~     function tests.~   "
85550|NCT02447237|"~     The study investigates the effect of liquid food on the intake of energy and protein compared~     to solid food. One group will receive dietary counselling in fulfilling their need for energy~     and protein from liquid food and the other group from solid food.~   "
85551|NCT02447224|"~     The major goal of the project is to demonstrate the feasibility of conducting a multi-center~     randomized clinical trial of antibiotic therapy versus appendectomy for the treatment of~     patients with acute uncomplicated appendicitis by conducting a single-site pilot study so as~     to optimize the chance of a large multi-center clinical trial's future success.~   "
85552|NCT02447211|"~     Radiation dermatitis is one of the most common side effects of radiotherapy approximately~     occurring in about 95% of patients receiving radiotherapy . Acute injury due to structural~     tissue damage, generation of free radicals, irreversible double-stranded breaks in nuclear~     and mitochondrial DNA, and initiation of an inflammatory response in the epidermis and dermis~     occurs within hours to weeks after radiation exposure. Radiation dermatitis due to pain and~     discomfort has an adverse impact on the quality of a patient's life.The radiation toxicities~     such as radiation dermatitis encountered in clinical practice are typically managed with a~     variety of topical agents such as water-based moisturizing creams or lotions, topical~     steroids, antiinflammatory emulsions, and wound dressings. Pharmacologic interventions for~     the prevention and treatment of these toxicity can be used to protect skin against radiation~     damage.Currently, there is no standard treatment for the prevention of radiation-induced~     dermatitis with demonstrated effectiveness.The aim of this randomized, double-blind,~     placebo-controlled study is to evaluate the effectiveness of topical doxepin for the~     prevention and management of radiation-induced dermatitis during postoperative radiotherapy~     for breast cancer.~   "
85577|NCT02446886|"~     The primary objective of this study is to determine if monthly pulse doses of a three-day~     course ACTH (H.P. Acthar®) is more effective at recovering myelin at 12 months, as measured~     by myelin water fraction (MWF), in new multiple sclerosis lesions as compared to one course~     of treatment.~      The main secondary objective is to utilize every three month MWF measurements to determine~     the peak time of remyelination in new multiple sclerosis lesions when followed over the~     course of 12 months.~   "
85666|NCT02445729|"~     The purpose of this study is to determine if surgical dressings removed at 24 hours or 48~     hours improves wound healing and appearance, and to determine if surgical dressings removed~     after 24 hours or 48 hours decreases the incidence of post-operative wound infections.~   "
85553|NCT02447198|"~     Legislation to allow medical marijuana has had a significant impact on the pediatric~     population of Colorado. There have been many reported different effects and properties of~     each of the over 60 known cannabinoids found in marijuana. The main exposures in pediatrics~     have involved the use of Cannabidiol (CBD) high- and Tetrahydrocannibinol (THC) low-content~     hash oil in children with epilepsy. The reported benefit of this oil is to have the~     anticonvulsant properties of CBD without the psychoactive components of THC. Human studies on~     the efficacy of CBD on epilepsy are few and limited.~      The investigators' specific aims are the following:~        -  Specific Aim 1: Describe the plasma pharmacokinetics of Cannabidiol (CBD),~          Tetrahydrocannibinol (THC), and their respective metabolites in pediatric patients with~          epilepsy.~        -  Specific Aim 2: Describe the plasma pharmacokinetics of other antiepileptic drugs (AEDs)~          taken in conjunction with CBD in order to evaluate drug interactions.~        -  Specific Aim 3: Describe parental perception of efficacy of CBD on control of epilepsy.~      The investigators will recruit children and their parents who are currently using or plan to~     use CBD for their seizure disorder. This study will NOT be providing patients with CBD.~     Consenting subjects will undergo a number of blood and urine collection that will be analyzed~     to describe the pharmacokinetics and possible drug interactions of CBD in pediatric epilepsy.~   "
85554|NCT02447185|"~     Proliferative diabetic retinopathy(PDR) is the leading cause of visual loss in diabetic~     patients. Operation is an efficient method to treat PDR. Anti-vascular endothelial growth~     factor (anti-VEGF) can be used as an adjuvant therapy which can make operation more easy.~   "
85555|NCT02447172|"~     This is a phase 3, randomized, controlled, blinded, multicenter study conducted in 3 parallel~     cohorts of diabetic patients with at least 1 infected foot ulcer. Patients will be randomized~     to receive 1 of 3 study treatments; systemic antibiotic therapy and standard ulcer care with~     either (A) daily application of a gentamicin-sponge, (B) daily application of a~     placebo-sponge or (C) no-sponge, in the ratio 2:1:1. Patients will be treated for~     approximately 28 days and return to the clinic weekly for safety and efficacy assessments.~     After completing treatment, patients will return to the clinic for scheduled follow-up visits~     approximately 10, 30, 60 and 90 days after treatment is stopped.~   "
85556|NCT02447159|"~     A randomized controlled trial will be conducted to assess the effectiveness of conditional~     cash transfers (CCTs) at increasing retention in prevention of mother-to-child transmission~     (PMTCT) services specifically, in relation to pickup of ARV drugs for infected mothers,~     delivery in the hospital setting, and receipt of drugs for exposed infants. Administrative~     data will be extracted from the All Babies are Equal program and hospital records. At 8-10~     weeks after delivery, an endline survey will also be conducted with each participant to~     provide a deeper understanding of the impact of the CCTs and to assess the reasons for~     retention in PMTCT services.~   "
85557|NCT02447146|"~     This is a controlled trial to assess the effects of resistance training on bradykinesia and~     physical function in patients with Parkinson's Disease. Forty patients diagnosed with~     Parkinson Disease stage 1 to 3 of the Hoehn and Yahr scale took part in the study and were~     allocated into 2 groups; Training Group performed a 9-week RT program twice a week while the~     Control Group attended lectures on the disease.~   "
85558|NCT02447133|"~     The objective of this study is to validate the TopQ cutoff scores, which have been previously~     determined.~   "
85559|NCT02447120|"~     The objective of this study is to collect OCT measurement data on normal healthy eyes in~     order to determine the reference limits for Topcon 3D OCT-1 Maestro based on the percentile~     points for 1%, 5%, 95%, and 99%.~   "
85560|NCT02447107|"~     Mobile technology can be used to passively capture data tracing features and fluctuations of~     patients' daily activities, including activity levels, location patterns, sleep, and a wide~     variety of other health-relevant metrics. This data can then be combined with contextual~     recall, collected through a mobile app, to enhance passively captured behavioral data. The~     resulting data collection is objective, real-time, and contextual, thus addressing the~     pitfalls of conventional measurement of pain treatment outcomes.~   "
85561|NCT02447094|"~     To study the effect of a telemedicine model of stroke care on patient-based outcomes.~   "
85562|NCT02447081|"~     This will be a prospective, multicenter, observational, non-randomized study to compile real~     world outcome data on the use of the Amulet™device in non-valvular atrial fibrillation (NVAF)~     subjects. The study is designed to follow the Instructions For Use (IFU) to gather data on~     the implant procedure through two years of follow up with the Amulet™ device in a commercial~     clinical setting.~   "
85563|NCT02447068|"~     This is a proof of concept, investigator blinded study to evaluate the efficacy and safety of~     a novel combination of a home narrow band ultraviolet B (NBUVB) lamp with an occlusive~     dressing in adult subjects with mild to moderate psoriasis vulgaris. Four interpatient arms~     will be used to compare the efficacy of combination of NBUVB with an occlusive dressing to~     the light alone and to dressing alone and no treatment. Ten patients will be enrolled in this~     6 weeks study.~   "
85564|NCT02447055|"~     The purpose of this study is to develop a novel platform for allo-SCT in multiple myeloma~     (MM) with the idea of maximizing anti-myeloma effect with conditioning and minimizing GvHD~     (graft versus host disease). Specifically, the investigators will use the Flu/Mel~     (fludarabine and melphalan) regimen. For GvHD prophylaxis, the investigators use the Hopkins~     PT-Cy (post-transplant cyclophosphamide) platform with the novelty of adding tocilizumab as~     both an anti-myeloma therapy and as a method to reduce GvHD. IL-6 has an important role in~     promoting the growth of myeloma cells and progression of disease.~   "
85594|NCT02446665|"~     Primary sclerosing cholangitis (PSC) is a chronic liver disease that can lead to liver~     cirrhosis, liver failure and liver cancer. Assessment of disease status is important to~     determine optimal treatment but the diagnosis of PSC is challenging. There is a dire need of~     an accurate non-invasive tool for longitudinal assessment of PSC. MR Elastography (MRE) has~     been recently proven to estimate liver fibrosis noninvasively and accurately. Estimation of~     liver fibrosis by MRE along with imaging derived morphological information (MRCP) will be~     utilized in this study comprehensively to provide a surrogate non-invasive imaging biomarker~     for monitoring disease status in PSC. Successful outcomes will provide an opportunity for~     optimal treatment triage including liver transplantation via accurate and non-invasive~     estimation of true disease status in PSC.~   "
85565|NCT02447042|"~     The administration of fluids intravenously is the first step in the stabilization of patients~     in septic shock. It is important to give the right dose of fluids, enough to improve the~     function of the cardiovascular system but not too much to drown the cells in water. In order~     to know that, the investigators use the fluid challenge which is the administration of a~     small amount of fluid in a short period of time in order to test the cardiovascular~     response to a dose of fluids. However, it is unclear how small this amount can be. The aim~     of this study is to find out the minimum volume required to perform an effective fluid~     challenge. The investigators hypothesize that the changes in the mean pressure in the~     cardiovascular system (socalled mean systemic filling pressure or Pmsf) during the~     administration of small amounts of fluid can be used to detect the minimum volume required to~     effectively test the cardiovascular system with a fluid challenge.~      On the other hand, microcirculation may remain impaired despite the stabilization of the~     macrocirculation. The microcirculation can be much more dynamic than the macrocriculation, so~     it is essential to observe the changes of both over time. Patients admitted at the~     investigators' intensive care unit (ICU) due to sepsis can be included in this study. The~     sample will be divided in 4 groups according to the volume of the fluid challenge: 2 ml/kg, 3~     ml/kg, 4ml/Kg and 5 ml/kg.~      The investigators will measure the Pmsf non-invasively using a pneumatic tourniquet inflated~     during one minute. Invasive arterial blood pressure will be observed during the inflation of~     the cuff in the arm to determine the Pmsf. The least significant change of Pmsf using this~     method is 14%. The minimal volume will be that one that achieve that change in Pmsf.~   "
85566|NCT02447029|"~     Despite global efforts to decrease discomfort during surgical abortion, pain remains a~     limiting factor in where and how procedures are performed. Several studies have investigated~     different methods of delivering cervical anesthesia prior to abortion, however to the best of~     the investigators' knowledge, there is no published data that 1) rigorously examines the~     effect of a time interval between local anesthetic administration and procedure initiation,~     or 2) explores whether adequate pain relief is possible through self-administered,~     non-invasive means alone. Research in this area has a significant public health impact, given~     the large number of women worldwide who seek abortions.~      The investigators propose to explore the effect of a locally applied vaginal lidocaine gel in~     place of the traditional paracervical block prior to first trimester surgical abortion. They~     hypothesize that lidocaine gel is no worse than paracervical block at decreasing abortion~     related pain at a variety of time points throughout the procedure. This is a non-inferiority,~     open label, randomized controlled trial.~      If self-administered vaginal gel is acceptable and effective, it would increase options for~     pain control during abortion and other gynecologic procedures.~   "
85567|NCT02447016|"~     The aim of this prospective, open label study is to check for differences in neuropsychiatric~     and neurocognitive measurements among patients that will be switched from Atripla to Eviplera~     among 40 patients.~   "
85568|NCT02447003|"~     This is a two-part study of pembrolizumab monotherapy in participants with metastatic~     triple-negative breast cancer (mTNBC). Part 1 of the study will examine the efficacy and~     safety of pembrolizumab monotherapy as first line or above treatment. Part 2 of the study, if~     done, will expand the investigation of pembrolizumab treatment in a subgroup of participants~     from Part 1 and will only start after enrollment in Part 1 has been completed.~   "
85569|NCT02446990|"~     The purpose of this study is to evaluate the effect of ivabradine on cardiovascular events in~     patients with coronary artery disease.~   "
85570|NCT02446977|"~     Administration of CBG000592 (riboflavin/vitamin B2) in patients with acute ischemic stroke to~     know if it causes a reduction of glutamate-mediated excitotoxicity.~   "
85571|NCT02446964|"~     This phase I trial studies the side effects and best dose of total bone marrow and lymphoid~     irradiation when given together with chemotherapy before donor stem cell transplant in~     treating patients with myelodysplastic syndrome or acute leukemia. Total marrow and lymphoid~     irradiation is a type of radiation therapy that targets bone marrow and blood, where the~     cancer is, instead of applying radiation to the whole body. Stem cell transplants use high~     doses of chemotherapy and radiation therapy, such as total marrow and lymphoid irradiation,~     to kill cancer cells, but these treatments kill normal cells as well. After chemotherapy,~     healthy cells from a donor are given to the patient to help the patient grow new blood cells.~   "
85572|NCT02446951|"~     Jaundice is a condition caused by elevated levels of bilirubin in the body otherwise known as~     hyperbilirubinemia. It occurs when there is an increase in bilirubin production or normal~     production with problems eliminating it from the body. Serum levels of bilirubin in excess of~     5 mg/dL signifies clinical jaundice, yet more than half of full term infants experience these~     levels within the first week of life. For those patients who have markedly elevated serum~     bilirubin levels, which phototherapy cannot sufficiently treat, the use of exchange~     transfusions is a viable option within the hospital setting. In comparison, bili-blankets~     have been used as a form of phototherapy for those patients being treated in a home-based~     setting to reduce the likelihood of hospital readmissions.~   "
85573|NCT02446938|"~     Transpulmonary pressure is frequently monitored in patients with mechanical ventilation.~     Right position of the catheter balloon is the key factor in accurate measurement. A simple~     method for confirming the balloon position will be validate in this study.~   "
85574|NCT02446925|"~     The Surefire Infusion System is a novel catheter initially developed to prevent reflux of~     embolic material into non-target vascular territories. Further research has demonstrated~     improved penetration and distribution of embolic material into treated arterial territories.~     The purpose of this study is to compare Y-90 glass microsphere distribution and penetration~     into cancerous tissue within the liver between a standard endhole catheter and the Surefire~     Infusion System.~   "
85575|NCT02446912|"~     The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment~     regimen of two doses of anifrolumab versus placebo in adult subjects with moderately to~     severely active, autoantibody-positive systemic lupus erythematosus (SLE).~   "
85576|NCT02446899|"~     The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment~     regimen of anifrolumab versus placebo in adult subjects with moderately to severely active,~     autoantibody-positive systemic lupus erythematosus (SLE).~   "
85578|NCT02446873|"~     The proposed study will fill an important gap in the literature by examining, through a~     randomized controlled trial, the effect of egg consumption on biochemical markers of choline,~     vitamin B-12, lipids, and amino acids in young children in a poor rural area of Ecuador.~     Children from Cotopaxi Province, Ecuador (n=180) will be randomized into one of two groups:~     1) intervention, receiving one egg per day for six months; or 2) control. Baseline and~     endline data on socio-economic factors, and child diet, morbidities, and anthropometry will~     be collected. Blood will also be drawn from the children at these time points for nutrient~     biomarker analyses. Through qualitative research the proposed study will provide insight into~     the attitudes, beliefs, and use of eggs by mothers and other caregivers during the~     complementary feeding period. The University of San Francisco in Quito (USFQ) will be the~     lead field coordinator of the research working in partnership with Washington University in~     St. Louis, Pan-American Health Organization (PAHO) and University of California, Davis.~   "
85579|NCT02446860|"~     Single arm, open label, phase II trial. Participants to undergo biopsy of primary tumour~     followed by 8 weeks of nivolumab therapy followed by nephrectomy. Nivolumab to be continued~     post-operatively~   "
85580|NCT02446847|"~     This study evaluates the effects of two infusions of 3BNC117 in preventing or delaying~     rebound of viral load during a brief treatment interruption of standard ART and its safety~     during a brief analytical interruption of antiretroviral therapy.~   "
85581|NCT02446834|"~     Compare the efficacy between intensive lifestyle intervention and drugs (GLP-1 Receptor~     Agonists, metformin and acarbose) for PCOS patients with early onset diabetes in their~     metabolic and reproductive abnormalities treatment; clear the treatment effect and mechanism~     of intensive lifestyle intervention to PCOS.~   "
85582|NCT02446821|"~     Prospective, multi-center, single-arm, open-label, Phase II clinical study to evaluate the~     effectiveness, device placement, safety, and tolerability of VeraCept to support commencing a~     Phase III Clinical Study~   "
85583|NCT02446808|"~     The purpose of this study is to determine whether the use of intraoperative nerve monitoring~     during robotic-assisted laparoscopic prostatectomy surgery improves post-surgery urinary~     continence and erectile function.~   "
85584|NCT02446795|"~     Advanced renal cell carcinoma is invariably fatal, with a life expectancy of 2-3 years since~     diagnosis. Sunitinib is the standard first-line treatment for this condition, but it is~     associated to multiple side effects, with fatigue being reported in 51-63% of patients. As~     sunitinib-induced fatigue is likely to be mediated by inhibition of AMPk function, the~     investigators hypothesize that isoquercetin, which is hydrolyzed in vivo to quercetin, a~     known AMPk activator, is able to reduce fatigue in kidney cancer patients taking sunitinib.~   "
85585|NCT02446782|"~     This is a prospective study to assess the efficacy and safety of a single dose of cefazolin~     2g IV for the prophylaxis of surgical site and pleural space infections in patients~     undergoing medical thoracoscopy.~   "
85586|NCT02446769|"~     This is a multicenter, randomized, parallel-group, open label study of the efficacy of~     AVAPS-AE to prevent re-hospitalization in hospitalized patients with comorbid COPD.~   "
85587|NCT02446756|"~     To observe the therapeutic effect of acupuncture on osteoarthritis(OA) and its efficacy on~     cartilage restoration,acupuncture and physiotherapy treatment were respectively given to two~     random groups. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was~     used to evaluate the motor function of knee joints, followed by magnetic resonance imaging~     (MRI) scanning to measure T2 values in ten cartilage sub-regions in tibiofemoral joints.~   "
85588|NCT02446743|"~     The purpose/aim of this study is to assess 1) the long-term persistence (4 to 7.5 years after~     the last dose) of bactericidal activity following primary vaccination with rMenB+OMV NZ in~     adolescents [who previously participated in parent studies V72_41 (NCT0142384) and V72P10~     (NCT00661713)] and 2) the kinetics of immune response following booster vaccination with~     rMenB+OMV NZ~   "
85589|NCT02446730|"~     The purpose of this study is to evaluate the efficacy and safety of 5mg maintenance dose (MD)~     of prasugrel in patients with acute myocardial infarction (AMI) who underwent percutaneous~     coronary intervention (PCI) with BiomatrixTM stent.~   "
85590|NCT02446717|"~     The purpose of this study is to assess the efficacy and safety of ABT-493 and ABT-530 with or~     without ribavirin (RBV) in participants with chronic hepatitis C virus, (HCV)-infection who~     previously failed treatment with a direct acting antiviral (DAA)-containing regimen.~   "
85591|NCT02446704|"~     This research study is evaluating the combination of olaparib and temozolomide as a possible~     treatment for Small Cell Lung Cancer.~   "
85592|NCT02446691|"~     This is Phase IV, Open label, Multicenter study. Subject's parents and/or legal guardian will~     be provided information about the trial. If interested and if eligible, they will then be~     asked to provide signed informed consent. The initial study visit can occur immediately after~     signed informed consent has been obtained. Approximately 135 subjects will be enrolled to~     receive 4 doses of intramuscular MenACWY vaccine at 2, 4, 6 and 12 months of age.~   "
85593|NCT02446678|"~     Background~        -  Patients presented to hospital with coffee ground vomiting and black stool may not be~          actually having upper gastrointestinal bleeding (UGIB)~        -  Hospital admission can be avoided if serious UGIB can be excluded~        -  To date, the only useful tool to triage patient for hospital admission in UGIB is by~          using clinical score such as Rockall score or Blatchford score~        -  These scores are cumbersome and only exclude the most benign cases, but they are not~          useful in differentiating those who needs intervention~        -  In our pilot study, investigators found that capsule endoscopy can be used to identify~          patients with fresh blood and real coffee ground substance in the stomach and it is~          superior to nasogastric tube~        -  Most of UGI lesions leading to bleeding can be diagnosed by capsule endoscopy~      Objectives The current study is designed~        1. to validate capsule endoscopy is an effective method in identifying patients with UGIB~        2. to study whether the capsule endoscopy can reduce requirement of hospital admission in~          patients with suspected UGIB~        3. to study if capsule endoscopy can help to identify patients with UGIB that may require~          urgent (within 24 hours) endoscopy and intervention~        4. to study the cost-effectiveness of capsule endoscopy being used as a triaging tool in~          the management of UGIB~        5. to compare the effectiveness of capsule endoscopy against Blatchford score in~          identifying patients with UGIB that may require endoscopic intervention.~   "
85596|NCT02446639|"~     Troponin T (TnT) is a component of the contractile apparatus of the striated musculature.~     Although the function of TnT is the same in all striated muscles found in the heart to form a~     TNT (cardiac TnT) differing significantly TnT of the skeletal muscles. Because of its high~     tissue specificity, cardiac TnT is a specific marker and highly sensitive of myocardial~     injury.~      Asymptomatic elevations of troponins is frequently found in patients with chronic renal~     failure in stage V, which present no clinical signs of acute or electrical myocardial injury.~      Many studies have been conducted in recent years to explain the origin and clinical~     significance of this elevation, but the results are controversial: cardiac dysfunction, left~     ventricular hypertrophy or chronic inflammation.~      Besides the effect of the dialysis session was evaluated on this biological parameter in~     different studies which together do not find Impact hemodialysis session on the value of~     troponin Achieving dosages rate hypersensitive serum troponin T in a dialysis population,~     will:~        -  to determine the evolution of TnT in time and what are the characteristics of the~          patients for whom this rate varies~        -  to know what its evolution during the session,~        -  to identify if possible the criteria that are responsible for the variation in the~          direction of increasing and / or its reduction~        -  and to characterize patients whose base rate is higher than the 99 percentile in the~          absence of clinical symptoms which could lead to establish reference population for this~          specific normal values. The Purpose of this study is to evaluate the serum troponin T in~          a hypersensitive dialysis population and verify what is the influence of the~          hemodialysis session, the session parameters and intradialytic events on changes in~          serum troponin T hypersensitive after a hemodialysis session. ~   "
85597|NCT02446626|"~     Background:~      The most common tick-borne illness in the United States, Lyme disease is caused by Borrelia~     burgdorferi bacteria that are transmitted to people by Ixodes scapularis ticks. Most cases of~     Lyme disease are cured by antibiotics, but some patients continue to experience symptoms~     despite the absence of detectable Lyme bacteria. Xenodiagnosis uses a vector to detect the~     presence of a disease-causing microbe.. Researchers will use live, laboratory-bred ticks to~     see if Lyme disease bacteria can be detected in people after completing antibiotic therapy~     and if that is more common in people who continue to experience symptoms such as fatigue and~     joint pain.~      <TAB>~      Objectives:~      - To see if ticks can be used to detect B. burgdorferi in people who have had Lyme disease~     and received antibiotic therapy and if it correlates with persistent symptoms.~      Eligibility:~        -  Adults at least 18 years old who have:~        -  Untreated erythema migrans (the Lyme disease rash); OR~        -  Untreated Lyme arthritis; OR~        -  Continuing symptoms after treatment for Lyme disease; OR~        -  Had Lyme disease and antibiotic treatment within the past 12 months.~        -  Healthy volunteers~      Design:~        -  Participants will be screened with medical history, physical exam, and blood tests.~        -  Visit 1:~        -  Blood and urine tests, health questionnaire.~        -  Up to 30 laboratory-bred, pathogen-free, larval ticks (each smaller than a poppy seed)~          will be placed under a dressing.~        -  Participants may have two small biopsies of skin .~        -  4 6 days later, Visit 2:~        -  Dressing will be removed and ticks will be collected.~        -  Participants will answer symptom questions.~        -  If many ticks are still attached, participants will have to come back the next day. If~          not enough ticks feed successfully, the procedure may be repeated.~        -  Participants will keep a diary of symptoms for 30 days. Over 3 months, they will be~          return to the clinic 3 times to see how they feel and answer questionnaires. Test~          results will be discussed.~   "
85598|NCT02446613|"~     This study will evaluate the duration of effect of GSK2245035 on allergic reactivity by~     repeating a nasal allergen challenge (NAC) approximately one year after treatment in subjects~     from TL7116958. This is a single centre, single period study in subjects with respiratory~     allergy/allergies who completed the study TL7116958 in 2014 to investigate the long term~     effect of previous treatment with GSK2245035 compared with placebo on total nasal symptoms~     elicited by nasal allergen challenge. Subjects and staff will remain blinded to the treatment~     received in the TL7116958 study (GSK2245035 or placebo). The study will consist of a~     screening visit to assess eligibility criteria, a study period consisting of a single visit~     when the nasal allergen challenge will be performed, and follow up by phone or a clinic visit~     at the discretion of the investigator 4-7 days following the allergen challenge. Eligible~     subjects will participate in this study for approximately70 days total from screening to~     follow up.~   "
85599|NCT02446600|"~     This randomized phase III trial studies olaparib or cediranib maleate and olaparib to see how~     well they work compared with standard platinum-based chemotherapy in treating patients with~     platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer that has come back.~     Olaparib and cediranib maleate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Cediranib maleate may stop the growth of ovarian, fallopian~     tube, or primary peritoneal cancer by blocking the growth of new blood vessels necessary for~     tumor growth. Drugs used in chemotherapy, such as carboplatin, paclitaxel, gemcitabine~     hydrochloride, and pegylated liposomal doxorubicin hydrochloride work in different ways to~     stop the growth of tumor cells, either by killing the cells, by stopping them from dividing,~     or by stopping them from spreading. It is not yet known whether olaparib or cediranib maleate~     and olaparib is more effective than standard platinum-based chemotherapy in treating patients~     with platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer.~   "
85600|NCT02446587|"~     SELECT is a multicenter, observational prospective study implementing a protocol to acquire~     imaging and clinical variables known to affect clinical outcomes after endovascular therapy~     in an effort to evaluate and compare the different selection methods and criteria currently~     used in practice for acute ischemic stroke patients in the anterior circulation with large~     vessel occlusion. The study aim is to evaluate prospectively different selection~     methodologies for endovascular therapy, to compare them against each other to identify which~     method provides the highest predictive ability in the selection of patients for IAT and to~     devise a formula that predicts patients' outcomes.~      This study will enroll patients based on the recent AHA guidelines (July 2015) regarding~     treatment of patients with acute ischemic strokes and large artery occlusions in the anterior~     circulation.~      Our goal is to collect complete imaging, clinical, and 90 day follow up data on 250~     endovascular therapy patients as well as up to 250 concurrent medical management patients as~     a comparison group.~   "
85601|NCT02446574|"~     This is a unicentered phase I/II study to explore the dose of paclitaxel and cisplatin with~     radiation therapy, and to document the adverse events for further clinical trial.~   "
85602|NCT02446561|"~     To determine whether three new oral formulations of a strong pain killer release the drug~     into the body in a similar pattern as the already marketed reference capsule formulation with~     or without food~   "
85603|NCT02446548|"~     The study is a randomised, double-blind, controlled 2 x 3 cross-over trial in which the renal~     effects of therapy with aliskiren (A), placebo (P) and losartan (L) will be compared. It~     consists of an 8-week run-in period, 8 weeks of active treatment with aliskiren or losartan~     (period 1), 8 weeks of active treatment with the alternative medication (period 2), and an~     8-week placebo administration between them.~   "
85667|NCT02445716|"~     This is a double-blind, randomized, placebo-controlled study. Seventy women, aged 35-75~     years, with treatment-emergent loss of libido will be randomly allocated to the treatment~     with a Transdermal nanoemulsion of Testosterone (500mcg) delivering 300 mcg of~     testosterone/day or an identical placebo nanoemulsion (PLA) for 12 weeks.~   "
85668|NCT02445703|"~     The purpose of this study is to compare the immunogenicity and safety of three different~     immunization schedules of inactivated hepatitis A vaccine (HAV) and/ or combined hepatitis A~     and B vaccine (HABV) in healthy Chinese infants.~   "
85604|NCT02446535|"~     Background Very recently, a test aimed at assessing dry weight (DW) in hemodialysis (HD)~     patients has been developed, the resistance stabilization test (REST)~      Aim of the study To verify if BIA-based DW (BIA DW) control is truly superior to current~     volume management in HD patients.~      Protocol of the study DW determined with clinical methods (Clinical DW) is the gold standard~     by definition: Clinical DW is determined under strict clinical surveillance by the same~     attending physician. He will be helped by a clinical score of volume state about symptoms and~     signs of hypo- or hypervolemia. The physician is asked to adjust the DW of the candidates~     until their clinical score reaches zero before the BIA measurement. This Clinical DW will be~     compared with BIA DW, as obtained after performing REST~      Phases of the study~      The protocol study includes three sequential phases:~        1. the Clinical DW is the gold standard by definition. Items of form B must be strictly~          applied until score = 0 is achieved;~        2. The Clinical DW as indicated by the score = 0 becomes the target DW of the next standard~          HD session, in which BIA measurements are performed: R values are recorded continuously~          during the session.~        3. REST is performed the following dialysis session. As per protocol, these dialysis~          sessions may be one or more than one, until flattening of the curve of the ratio R0/Rt~          (R0 is R at time 0 and Rt is R at a given time t during the HD session) of less than +~          1% over 20 minutes in the presence of ongoing UF, is obtained.~      Primary outcome~      The primary outcome is the definition for each patient of the gold standard DW when comparing~     the Clinical and the BIA DW. Two are the possible scenarios:~        1. the Clinical and the BIA DW will be very similar ( < + 0.5 kg). Therefore, a reciprocal~          validation of the two methods for that specific patient has been obtained;~        2. the Clinical and the BIA DW are different ( > + 0.5 kg). If the BIA DW will be confirmed~          in the following six dialysis sessions, it means that the gold standard DW for that~          patient is the BIA DW.~   "
85605|NCT02446522|"~     There is no shared vision relating to integrity and quality of the conduit after the impact~     on the vein wall during vein harvesting. In this connection, the investigators studied the~     initial state of the venous conduit, interoperation damages of the vein and postoperative~     wound complications while using two methods of GSV harvesting.~   "
85606|NCT02446509|"~     Bipolar disorder is a debilitating chronic illness characterized by periods of elation and~     depression. Since deinstitutionalization of the mentally ill over 40 years ago, families have~     become major caregivers for patients with bipolar disorder . This illness imposes a~     substantial and chronic burden on family caregivers Despite their persistent stress and~     burden, these caregivers have been largely ignored. Interventions to help them have been very~     limited. One comprehensive intervention was developed and implemented by Miklowitz (2008) and~     has shown to be effective in reducing caregiver depression and improving health outcomes.~     However, this intervention and is highly complex, long, and was given on an individual basis,~     significantly raising the cost of the program. One core component of the Miklowitz (2008)~     intervention is psychoeducation, which provides the fundamental support and information~     needed to caregivers on an individual basis.~      In this pilot study, the intervention group will receive 7 weekly psychoeducation sessions.~     After completion of these sessions in the intervention group, the wait list control group~     will receive the same weekly sessions. In this study, the investigators plan to test the~     feasibility and potential efficacy of this specific psychoeducation intervention implemented~     in a group setting. The investigators will also examine the effects of this psychosocial~     intervention on biological mechanisms (cortisol and inflammatory biomarkers) and health~     outcomes.~      The specific aims are to:~        1. Test the feasibility of implementing a 7-week group psychoeducation program for family~          caregivers of patients with bipolar disorder by assessing recruitment and retention~          rates, attendance, satisfaction with the program, and data and sample collection rate.~        2. Explore the effect of the intervention on caregiver outcomes (depression, burden, health~          status, mental wellbeing, cortisol, interleukin (IL)-1 and IL-6 levels.~      The intervention will be delivered by at the University of Texas Health Science Center at~     Houston Center of Excellence for Mood Disorders (CEMD) and at the University of Texas Health~     Science Center at Houston School of Nursing. Forty family caregivers of patients with bipolar~     disorder will be recruited into the study.~   "
85607|NCT02446496|"~     This is an open-label, randomized, single dose, two-sequence two-period crossover study,~     separated by 7 days washout interval from the first Study Drug Administration. This study is~     conducted to determine the bioequivalence of cefadroxil from DURICEF™ film coated tablets~     manufactured by Smithkline Beecham Egypt, LLC affiliated co. to GalaxoSmithKline (GSK) and~     cefadroxil from BIODROXIL™ film coated tablets manufactured by Kahira Pharm &amp;Chem .Ind.~     Co . for Novartis Pharma (NP) after a single oral dose administration of each to healthy~     adult subjects under fasting conditions. In Period 1, subjects will be randomized to receive~     cefadroxil tablet manufactured by either GSK or NP. Following a washout of at least 7 days,~     subjects will be crossed over in Period 2 to receive the cefadroxil tablet that they did not~     receive in Period 1. DURICEF is a trademark of the GSK group of companies. BIODROXIL is a~     trademark of Sandoz.~   "
85608|NCT02446483|"~     This is an open-label, randomized, single dose, two-sequence, two-period crossover study,~     separated by 7 days washout interval from the first study drug administration.~      In this study, the bioavailability of Rabeprazole from Idiazole 20 milligram (mg) delayed~     release (DR) tablets and PARIET 20 mg DR tablets after a single oral dose administration of~     each to healthy adults under fasting conditions, will be investigated by determining the 90%~     confidence limits for the log-transformed ratio (Test product / Reference product) for the~     bioequivalence parameters. The influence of sequence, product and period effect will be~     tested by analysis of variance (ANOVA).~      In this study a total of 60 subjects plus 1-4 additional subjects will be enrolled and split~     into two groups (Group A and B) of 30 each. For each subject, a total of 33 blood draws will~     be done and the volume of blood will not exceed 300 milliliters (mL) for the study.~      PARIET is a registered trademark of EISAI Co. Limited.~   "
85609|NCT02446470|"~     This study is a prospective, randomized controlled trial comparing the sinus tarsi approach~     to the extensile lateral approach for surgical fixation of calcaneus fractures.~      It is hypothesized that open reduction and internal fixation of intra-articular calcaneus~     fractures using a sinus tarsi approach will provide equivalent fracture reduction and stable~     fixation with significantly decreased wound complication rates in comparison to an extensile~     lateral approach.~   "
85610|NCT02446457|"~     The goal of this clinical research study is to learn if the combination of pembrolizumab and~     rituximab can help to control relapsed follicular lymphoma (FL). The safety of this drug~     combination will also be studied.~      This is an investigational study. Pembrolizumab is FDA approved and commercially available~     for the treatment of melanoma. Rituximab is FDA approved and commercially available for the~     treatment of non-Hodgkin's lymphoma and certain types of leukemia. The combination of these~     drugs to treat FL is investigational. The study doctor can describe how the study drugs are~     designed to work.~      Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.~   "
85611|NCT02446444|"~     The purpose of this study is to determine the effectiveness of enzalutamide as part of~     adjuvant androgen deprivation therapy (ADT) with a luteinizing hormone releasing hormone~     analogue (LHRHA) in men having radiation therapy for localised prostate cancer at high risk~     of recurrence.~   "
85612|NCT02446431|"~     Most pediatric patients with solid tumors respond to initial high-dose, intensive therapy and~     complete treatment in remission. High-risk patients however, frequently have recurrent~     disease which is then treated with ad hoc regimens or early phase therapies with little~     benefit to the patient. Metronomic therapy (MC), defined as lower dose continuous drug~     exposure, has been successfully tested in pediatric leukemias with excellent results in terms~     of improved outcome, toxicity profiles, and cost. MC has been applied to solid tumors with~     little success, but has been implemented usually in the relapsed setting at a time of high~     tumor burden and disease resistance.~   "
85613|NCT02446418|"~     The combination of FF, an ICS and VI, an orally inhaled LABA has been developed as a~     once-daily combination therapy for the long-term maintenance treatment of asthma in adults~     and children >=12 years of age. Pivotal phase III studies have demonstrated the safety and~     efficacy of FF/VI in asthma. However, it is increasingly acknowledged that randomised~     clinical trials tend to be highly controlled and enrol a more highly selected subject~     population than is expected to be prescribed the medication post-approval. There is a need~     for data in a more representative population in close to a 'real life' conditions, where~     physicians have the ability to choose the best treatment in their view for any individual~     subject and adapt treatments to subjects' characteristics and response. This multi-center,~     open-label, randomized, parallel group study will evaluate the efficacy and safety of FF/VI~     compared with two usual ICS/LABA fixed combination (fluticasone propionate/salmeterol [FP/S]~     or budesonide/formoterol [BUD/F]) in subjects with persistent asthma, in a close to real~     life settings. FF/VI will be administered once-daily (QD) via ELLIPTA dry powder inhaler~     (DPI) and FP/S or BUD/F will be administered twice daily (BID) via DISKUS™ and TURBUHALER™~     DPI respectively. ELLIPTA is a new powder inhaler designed to be easy to use. The total~     duration of subject participation will be approximately 6 months (24 weeks). ELLIPTA and~     DISKUS are registered trademarks of the GSK group of companies. TURBUHALER is a registered~     trademark of AstraZeneca.~   "
85614|NCT02446405|"~     The purpose of this study is to determine the effectiveness of enzalutamide, versus a~     conventional non-steroidal anti androgen (NSAA), when combined with a luteinizing hormone~     releasing hormone analog (LHRHA) or surgical castration, as first line androgen deprivation~     therapy (ADT) for newly diagnosed metastatic prostate cancer.~   "
85615|NCT02446392|"~     In this project, intensive care unit (ICU) patients treated with beta-lactam antibiotics are~     included with the aim to investigate the potential underdosing in this patient group. Four~     regional ICU-clinics are recruiting consecutive patients (n=120) and samples are taken before~     the next dose is administered for three consecutive days.~   "
85616|NCT02446379|"~     This study will evaluate the performance of the EnLightTM and LightPathTM Imaging Systems in~     detecting tumour lesions in patients with gastric, pancreas, bile duct or duodenal cancer.~      EnLightTM will be used to detect positron emission and the LightPathTM system to detect~     Cerenkov Luminescence. Both are emitted by the Positron Emission Tomography (PET) agent.~      The study will also evaluate the patient safety and radiation safety of the EnLightTM, and~     the safety for the device operators and surgical staff of the LightPathTM Imaging System.~   "
85617|NCT02446366|"~     This phase I trial studies the side effects and the best dose of hypofractionated~     stereotactic body radiation therapy (SBRT) in treating patients with prostate cancer that was~     removed by surgery. Hypofractionated SBRT delivers higher doses of radiation therapy over a~     shorter period of time and may kill more tumor cells and may have fewer side effects than~     standard radiation therapy.~   "
85618|NCT02446353|"~     A Randomized, Open Label, Single dose, Cross-over, Phase I Trial to Investigate Safety and~     Pharmacokinetics of Apetrol ES and Megace® in Healthy Male Volunteers.~   "
85619|NCT02446340|"~     The purpose of this study is to examine safety outcomes in healthy volunteers after systemic~     administration of multiple ascending doses of dalazatide.~   "
85620|NCT02446327|"~     The main objective is to replicate the validation of omics biomarkers of left ventricular~     diastolic dysfunction in patients with metabolic syndrome.~      The aim was to recruit overall 750 patients in Europe (100 for France). Currently, 625~     patients were enrolled in Europe and 47 in France.~   "
85621|NCT02446314|"~     The purpose of this study is to determine whether a 6 month dietary intervention with wild~     blueberry powder and extract stabilised with L-cysteine and L-glutathione have an effect on~     cognitive performance in participants aged between 65 - 80.~   "
85622|NCT02446301|"~     This study is to evaluate the relative bioavailability of nalbuphine after single IM~     injection of Sebacoyl Dinalbuphine Ester (SDE) injection and Bain®, Nalbuphine HCl IM~     injection in healthy volunteers.~   "
85623|NCT02446288|"~     The study is an open-label, prospective, multicenter, randomized, two treatment parallel,~     comparison study of the TMJ NextGeneration and DSG Relaxer in the reduction of nocturnal~     bruxism episodes in subjects diagnosed with sleep bruxism.~   "
85624|NCT02446275|"~     Objective: The aim of this study was to determine the efficacy of suboccipital inhibitory~     manual therapy treatment in migraine compared to treatment based on Myofascial Trigger Points~     (MTrPs) and their stretching, often being hypersensitive in patients with migraine.~      Material and methods: 27 patients in two groups participated in the study: a) the control~     group received combined techniques based on MTrPs and bilateral stretching in the trapezius~     and sternocleidomastoid muscle (SCM); b) the experimental group was applied the same~     techniques as those applied in the control group plus suboccipital inhibition. The treatment~     lasted for 8 weeks and the impact, disability and quality of life were assessed in both~     groups.~   "
85625|NCT02446262|"~     Background:~      - Painful stimuli cause changes in a network of brain regions called the Pain Matrix. But~     most of these regions respond to many other stimuli, not just pain. Researchers want to~     understand how different factors influence pain. They want to test what happens when people~     expect different levels of pain and receive treatments that can modify pain. They want to see~     if these factors influence decisions about pain and how the body responds to it. They also~     want to compare pain with responses like taste and vision.~      Objectives:~      - To better understand how pain and emotions are processed and influenced by psychological~     factors.~      Eligibility:~      - Healthy volunteers ages 18 50.~      Design:~        -  This study requires 1 to 2 clinic visits that last 1 to 3 hours.~        -  Participants will be screened with medical history and physical exam.~        -  Some participants will have one or more magnetic resonance imaging (MRI) scans of their~          brain. For MRI, participants will lie on a table that slides in and out of a cylinder.~          The scanner makes loud knocking noises. They will get earplugs.~        -  Participants heart activity will be recorded with electrocardiogram. Their pulse,~          sweating, and breathing will be monitored.~        -  Some participants will take a taste test. Others may perform simple tasks. Others may~          receive pain in their arm, leg, or hand. The pain will come from heat or electric~          shocks. Others may judge pain using a topical pain-relieving cream. Some of these tests~          may be given during MRI.~        -  Participants will fill out questionnaires.~        -  The study will last 3 years.~   "
85626|NCT02446249|"~     Background:~      - Radiation can cause the parotid salivary glands to make less saliva (dry mouth). This can~     cause problems like infections and tooth decay. Researchers hope a new drug can help people~     with dry mouth caused by radiation.~      Objectives:~      - To examine the safety of AAV2hAQP1 gene therapy. To see if the drug increases saliva in~     people whose parotid glands have had radiation.~      Eligibility:~      - People at least 18 years of age with a history of radiation therapy for head and neck~     cancer.~      Design:~      Participants will be screened in 2 visits with:~        -  medical history~        -  physical exam~        -  scans~        -  saliva collections~        -  sialogram. A substance is injected in the parotid gland and X-rays are taken.~        -  non-drug infusion~        -  IV dose of glycopyrrolate to stop saliva~      <new paragraph>~      3-day hospital stay: Participants will get the gene infusion. The AAV2hAQP1 will be in a~     solution in a syringe. It will be slowly pushed through an opening into the gland inside your~     mouth.~      10 outpatient visits over 3 years. These may include:~        -  repeats of screening tests~        -  blood and urine tests~        -  oral and head and neck exams, including a thin scope in the airway~        -  questionnaires~        -  small piece of skin taken~        -  small piece of parotid tissue taken by either: a small video-scope in the parotid duct~          that also takes pictures or by a small needle guided by ultrasound~        -  scans. Participants lie in a machine or a scanner The machine may feel close to the body~          or face. . For some, a substance will be injected in a vein or put in the mouth.~        -  Participants will keep a diary about how they feel before and after the therapy.~        -  oral microbiome gingival and buccal swab~   "
85627|NCT02446236|"~     This is a dose-escalation to determine the MTD and/or RPII for combinations of ibrutinib~     (PCI-32765) plus lenalidomide/rituximab in patients with relapsed/refractory mantle cell~     lymphoma.~   "
85628|NCT02446223|"~     Evaluate the Efficacy and Safety of Large-Scale Field-Directed Topical Therapy of Actinic~     Keratosis of the Chest w/Ingenol Mebutate 0.015%~   "
85629|NCT02446210|"~     The long‐term goal is to acquire scientific knowledge that can be used to develop~     mechanistic-driven intervention strategies aiming at restoring upper and lower-limb motor~     function in individuals with cervical or thoracic spinal cord injury (SCI). The proposed~     project will examine cortical, corticospinal, and spinal contribution to bilateral hand and~     arm muscle activity during bilateral movements and spinal contributions to lower limb muscle~     activity. By comparing changes in different sites within the Central Nervous System (CNS),~     the investigators may also identify key mechanisms that might be differentially affected by~     the injury, plasticity, and training.~   "
85630|NCT02446197|"~     Early initiation of therapy post stroke has been associated with improved long-term outcomes,~     and functional activity dose during the first week of inpatient rehabilitation predicts both~     gait velocity at discharge and length of time to independent walking. The primary study~     objective is to pilot the feasibility of integrating a patient-directed activity program into~     inpatient rehabilitation following stroke. The second study objective is to identify if~     participation in the patient-directed activity program improves functional ability and health~     related quality of life.~   "
85631|NCT02446184|"~     This is a pilot study to evaluate the safety, feasibility, and effectiveness of fetal~     cystoscopy as an experimental procedure in avoiding perinatal death and renal impairment and~     to compare to the investigators clinical experience with fetal vesicoamniotic shunting.~   "
85632|NCT02446171|"~     This clinical study is an open-label, randomized, 4-period, 4-treatment, crossover,~     single-center, single-dose bioavailability study with alternate methods of administration of~     crushed naloxegol tablets, 25 mg and of a naloxegol solution formulation, 25 mg, compared to~     whole naloxegol tablets, 25 mg, in healthy subjects.~      The main objective of this study is to determine the bioavailability of each of three~     alternative methods of naloxegol administration compared to whole naloxegol tablets given~     orally by assessment of the primary pharmacokinetic (PK) parameters of naloxegol~   "
85633|NCT02446158|"~     Chlorhexidine is used in central line dressing changes and is effective in reducing line~     infections. It is unclear if daily chlorhexidine care at the exit site in peritoneal dialysis~     (PD) patients can reduce the risk of Staphylococcus aureus (SA) colonization or exit site~     infection.~   "
85634|NCT02446145|"~     Acute myeloid leukemia (AML) is a disease with a poor prognosis including a 5-year overall~     survival (OS) of app. 20% for the entire population. In particular, the outcome of elderly~     patients with AML is dismal and the majority of patients die within the first year after~     diagnosis. This is also because treatment options for elderly patients with AML significantly~     differ from patients of younger age. In fact, comorbid conditions are common among the~     elderly such as heart disease, renal insufficiency and vascular disease thus influencing the~     ability to withstand intensive therapy. Elderly patients are also more likely than younger~     patients to develop severe, life threatening infections during the course of treatment. In~     addition to infectious complications, hemorrhages due to severe thrombocytopenia are~     responsible for morbidity and mortality in a considerable amount of patients. Compared with~     younger AML patients, elderly individuals with AML display a higher incidence of~     poor-prognosis karyotypes, of a preceding myelodysplastic syndrome (MDS), and greater~     expression of proteins involved in intrinsic resistance to chemotherapeutic agents. As a~     result conventional anthracycline based chemotherapy is only infrequently used in patients~     above the age of 65 years. Based on a recent randomized trial (Kantarjian et al. 2012)~     low-intensity epigenetic therapy with decitabine (DAC) has become the first-line standard of~     care in most European countries including Germany. Nevertheless, even with this treatment the~     1-year OS is approximately 30 % only. Furthermore, severe thrombocytopenia is a main side~     effect of this therapy and can prevent adequate continuation of treatment being crucially for~     treatment success. Supportive care with platelet transfusions is effective primarily only~     over short periods and often requires hospitalization and therefore lowers the quality of~     life of these patients in their palliative situation. Therefore, patients could benefit from~     an approach aiming at an increase of platelet counts through combined use of DAC with an oral~     thrombopoietin receptor agonist like eltrombopag (EPAG). This could allow for a better~     adherence to DAC therapy by preventing dose delays due to prolonged thrombocytopenia.~     Additionally, the potential antileukemic effect of EPAG could also be beneficial for these~     AML patients.~   "
85635|NCT02446132|"~     This is an extension study of the Phase 3 Studies 15-AVP-786-301 and 15-AVP-786-302, which~     also allows participants from the Phase 2 Study 12-AVR-131 to be included.~   "
85669|NCT02445690|"~     One hundred and fifty patients with Crohn's disease involving the terminal ileum or the~     colon, in clinical remission, with or without endoscopic activity will be included. Thrombin~     generation will be measured and correlated with the simplified endoscopic activity score. The~     patients will be evaluated for development of deep vein thrombosis after one-year of~     follow-up.~   "
85709|NCT02445170|"~     The present study assesses the health-related quality of life of diabetic transmetatarstal~     and below-knee prosthetic user. The study design is cross-sectional with a retrospective~     review of patient hospital records and an assessment with patient-reported outcome measure.~   "
85636|NCT02446119|"~     Gastroparesis is a disorder characterized by symptoms from gastric retention in the absence~     of mechanical obstruction. Gastric emptying is a highly regulated process reflecting the~     integration of the propulsive forces of proximal fundic tone and distal antral contractions~     with the functional resistance provided by the pyloric sphincter. Pylorospasm has been~     reported in some patients with gastroparesis. This study protocol will assess pyloric~     sphincter pressure and geometry in patients with gastroparesis and control subjects without~     symptoms of gastroparesis. The commercially available FDA approved endoscopic functional~     luminal imaging probe (EndoFLIP) catheter will be used, which measures diameter, pressure,~     length, and distensibility of gastrointestinal sphincter muscles along the balloon distance.~     It is used to measure the pressure characteristics of the lower esophageal sphincter during~     bariatric surgery for obesity, during Heller myotomy for achalasia, and during Nissen~     fundoplication for gastroesophageal reflux disease. In this study, during upper endoscopy,~     which is routinely performed under sedation, patients with gastroparesis and controls without~     gastroparesis symptoms will have their pyloric sphincter assessed with EndoFLIP. After~     passage of the endoscope into the stomach, the EndoFLIP catheter will be introduced alongside~     the endoscope and advanced through the pyloric sphincter as visualized endoscopically. The~     investigators will measure the pressure and contour of the pyloric sphincter using three~     successive volume distensions of the EndoFLIP balloon (20 ml, 30 ml, 40 ml). The~     investigators will compare the results between the gastroparesis patients and the control~     patients without gastroparesis. Through this study, the investigators will better understand~     the abnormalities of the pyloric sphincter in patients with gastroparesis.~   "
85637|NCT02446106|"~     The objective of this study is to compare energy intake following consumption 0.5% MSG versus~     a control with no added MSG and matched for sodium in healthy non-smoking premenopausal~     female adults.~   "
85638|NCT02446093|"~     The study will investigate if the addition of GMCI to neoadjuvant mFOLFIRINOX +~     chemoradiation is safe and improves the clinical outcome of borderline resectable and~     unresectable locally advanced pancreatic adenocarcinoma, as measured by resection rate,~     progression-free survival and overall survival.~   "
85639|NCT02446080|"~     Constipation is defined as a disorder characterized by persistent difficulty to evacuate or a~     feeling of incomplete evacuation and / or infrequent bowel movements. Many factors contribute~     to the onset of constipation, such as changes in dietary intake and fluid intake, decrease in~     consumption of products containing fiber, intake of drugs or laxatives, decreased intestinal~     motility and physical inactivity. The objective was to evaluate the effect of consumption of~     dairy products with probiotics on constipation. Randomized double-blind clinical trial in the~     city of Bom Retiro do Sul / RS, Brazil. They were recruited 60 female patients aged 20-50~     years after application of the Rome III criteria (World Gastroenterology Organization, 2010)~     and Range Bristol (World Gastroenterology Organisation, 2010) were diagnosed with~     constipation. Patients were randomized into two groups, where one group will receive the milk~     drink with probiotics and the other group will receive a probiotic milk drink without~     (control group). The milk beverage consumption period shall be 60 days where each patient~     will consume 150 ml of milk drink a day, with breakfast or morning snack.~   "
85640|NCT02446067|"~     The present study measures the cerebral hemodynamic indices of alcohol dependent patients and~     observe the relative changes in these parameters with rTMS application.~   "
85641|NCT02446054|"~     Evaluation the change of patients' glycosylated hemoglobin (HbA1c) after 12 weeks diet~     control~   "
85642|NCT02446041|"~     The purpose of this retrospective, non-interventional sutdy is to compare the effectiveness~     of ICS/LABA combination therapy in the reduction of COPD exacerbations during the 12 months~     after initiation of therapy between COPD patients who are adherent to the index medication~     and those who are non-adherent.~   "
85643|NCT02446028|"~     The purpose of this study is to evaluate the safety and efficacy of BIOD-531 compared to~     Humalog®Mix 75/25 in patients with type 2 diabetes.~   "
85644|NCT02446015|"~     The purpose of this study is to evaluate the clinical benefits of SYSTANE® ULTRA Lubricant~     Eye Drops using total ocular surface staining scores in subjects with dry eye administering~     it either as a scheduled regimen or as-needed after 28 days of treatment.~   "
85645|NCT02446002|"~     A Phase 1, open-label, single-arm study with two single doses of lofexidine and multiple~     doses of naltrexone in healthy adult subjects to determine the effect of naltrexone on the~     single dose pharmacokinetics of the oral lofexidine formulation.~   "
85646|NCT02445989|"~     The investigators propose to explore the hypothesis—supported by limited data—that a~     contraceptive vaginal ring (CVR) that is commonly used in the United States, the NuvaRing,~     will enhance women's genital and reproductive health. The investigators propose that this CVR~     will increase the bacteria that help the vaginal environment protect against infection by HIV~     and other STIs, and that in women who already have HIV, use of the CVR will lower the~     quantity of HIV that is shed in the female genital tract.~   "
85647|NCT02445976|"~     The goal of this clinical study is to determine the efficacy and safety of Seviteronel, a~     lyase-selective inhibitor of CYP17 and an androgen receptor antagonist, in patients with~     castration-resistant prostate cancer (CRPC) who have been previously treated with~     enzalutamide and/or abiraterone.~   "
85648|NCT02445963|"~     This study is an open-label, dose-escalating Phase 1 investigation of S. flexneri 2a~     InvaplexAR vaccine. A total of up to 40 subjects will receive one of four S. flexneri 2a~     InvaplexAR vaccine doses. The vaccine will be administered intranasally (without adjuvant).~   "
85649|NCT02445950|"~     The purpose of this study is to examine whether the technology (web-based coaching, profiling~     and suggestion tool) brings added value to the traditional phone coaching in occupational~     health context. The interventions are phone counseling interventions. The other intervention~     exploits additionally a specific web-based coaching, profiling and suggestion tool.~   "
85694|NCT02445365|"~     Ulcerative colitis (UC) is a chronic relapsing inflammatory bowel disease (IBD). At the time~     of diagnosis it is not possible to predict the course of the disease, which can range from a~     few flares in a lifetime to uncontrollable disease leading to hospitalization, surgery and~     stoma. There is a continuous need to improve treatment as well as diagnostic and prognostic~     tools.~      This study evaluates the clinical efficacy, tolerability and feasibility of remote ischemic~     conditioning (RIC) in patients with moderate active ulcerative colitis (UC). The~     investigators hypothesize that RIC beyond the well known effect on reperfusion tissue damage~     has a clinically relevant anti-inflammatory effect in UC. RIC constitute a repeated brief and~     non-harmful suppression of blood circulation in a limb. The mechanism of action of RIC is~     likely to involve suppressed inflammation and cell death.~      Our study is a randomized clinical controlled study including 38 patients. Patients will~     receive RIC or sham for 10 consecutive days.~      The effect of RIC on active UC is evaluated by changes patient's symptoms, endoscopy~     findings, and various markers in the blood, faeces and the intestinal wall.~   "
85695|NCT02445352|"~     The purpose of this study is to evaluate efficacy and safety of DP-R207 in patients with~     primary hypercholesterolemia.~   "
85650|NCT02445937|"~     This is a stepped wedged randomized controlled trial comparing the PARTNER intervention with~     usual care in 5 Intensive Care Units. The overarching goal of this research project to ensure~     patient-centered decisions about the use of intensive treatments for patients with advanced~     critical illness. In a prior project, the investigators developed the PARTNER program~     (PAiring Re-engineered ICU Teams with Nurse-driven Education and OutReach), a 4-facet,~     team-based intervention that re-engineers how surrogates are supported in ICUs, including: 1)~     changing care defaults to ensure clinician-family meetings within 48 hours of enrollment~     and frequently thereafter; 2) protocolized, nurse-administered coaching and emotional support~     of surrogates before and during clinician-family meetings, 3) increased use of palliative~     care services for patients with a poor prognosis; and 4) structured communication at care~     transitions about patient's health care preferences and goals. The investigators propose to~     begin deployment of the PARTNERII program in the spring of 2015 enrolling 690 patients and~     690 surrogate decision makers in 5 ICUs using a stepped wedge design. The investigators~     expect to achieve the following project goals:~        1. To increase the patient-centeredness of end-of-life decisions, and to increase the~          quality of clinician-family communication.~        2. To decrease the psychological burden on family members acting as surrogates.~        3. Lower costs: To reduce total health care costs by increasing the use of palliative care~          and hospice services and decreasing unwanted readmissions near the end of life.~   "
85651|NCT02445924|"~     This study will be carried out on 40 subjects at Chest department Tanta university hospital~      The subjects will be classified into three groups:~        -  Group I: will include ten non smoker volunteers (control group I).~        -  GroupII: will include ten smoker volunteers (control groupII).~        -  Group III: will include twenty NSCLC patients confirmed by pathological examination of~          bronchoalveolar examination (BAL), brush and/or biopsy.~   "
85652|NCT02445911|"~     This study will consist of multiple ascending oral doses in up to 3 groups, for 29 days.~   "
85653|NCT02445898|"~     The study evaluates the pathophysiological effects of a single dose Methylprednisolone~     administered prior to total hip-arthroplasty (THA) surgery. The investigators examine the~     effect on orthostatic intolerance, orthostatic hypotension and heart rate variability (HRV)~     to evaluate the efficacy of Methylprednisolone regarding blood pressure regulation and~     autonomic responses after THA.~      Half of participants will receive intravenous Solu-Medrol 125 mg, while the other half will~     receive placebo.~      The investigators hypothesize that the group receiving Methylprednisolone will be less~     orthostatic intolerant, experience less orthostatic hypotension and have an improved~     autonomic response compared to the placebo-group, early after THA.~   "
85654|NCT02445885|"~     Although recommended therapy for patients with ST-segment elevation myocardial infarction is~     primary PCI, it remains unestablished whether patients with a symptom duration of more 12~     hours benefit from acute revascularisation.~      This study aims to investigate whether acute intervention is superior to subacute~     intervention in these patients.~   "
85655|NCT02445872|"~     Aprepitant is an oral neurokinin-1(NK-1) antagonist which is used for the prevention of~     chemotherapy-induced nausea and vomiting (CINV). This phase II clinical trial was designed to~     evaluate the efficacy of aprepitant in the prevention of CINV with lung cancer patients~     receiving 3-day cisplatin-based chemotherapy.~   "
85656|NCT02445859|"~     We propose to randomise patients due to undergo colorectal surgery to standard antibiotic~     prophylaxis or an interventional antibiotic prophylaxis regimen and assess surgical wound~     infection rates. Standard antibiotic prophylaxis is a pre-operative injection of cefuroxime,~     repeated every 4 hours. The intervention regimen is a loading dose of cefuroxime followed by~     a continuous infusion of cefuroxime until the end of surgery. The intervention regimen dosing~     will be calculated using a patient's renal function and body weight. The intervention regimen~     will target a free serum drug concentration of 64mg/L. This serum level is 4x the MIC90 for~     colonising Enterobacteriaceae. The rational for this dosing regimen is summarised below. The~     primary objective of the study is to reduce by 50% the rate of surgical wound infections~     after colorectal surgery.~   "
85657|NCT02445846|"~     The purpose of this study is to provide evidence on the performance and operational~     characteristics of commercially available dual HIV/syphilis Rapid Diagnostic Tests (RDTs) in~     Zambia for their introduction into antenatal care and other settings.~   "
85658|NCT02445833|"~     Efficacy of an Internet-based self-guided intervention for promoting healthy habits and~     weight loss in hypertensive people with overweight and obesity: A Randomized Controlled Trial~   "
85659|NCT02445820|"~     This study retrospectively assess the effect or using balanced hydroxyethyl sctarch (HES)~     130/0.4 or a balanced crystalloid solution as a pump prime and for intraoperative fluid~     therapy on the risk of early acute postoperative kidney injury in adult cardiac surgery~     patients.~   "
85660|NCT02445807|"~     This study will compare the efficacy and safety of DFD-06 Cream to Vehicle Cream for topical~     treatment of moderate to severe plaque psoriasis after 3, 7, and 14 days of treatment.~   "
85661|NCT02445794|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of~     RT001 in patients with Friedreich's ataxia.~   "
85662|NCT02445781|"~     Hypoglycemia can produce a spectrum of pro-inflammatory and pro-atherothrombotic changes. To~     date no studies appear to have investigated the effects of differing levels of hypoglycemia~     on the vasculature and pro-atherothrombotic balance during hypoglycemia in healthy man. The~     specific aim of our study will be to determine the effects of differing levels of~     hypoglycemia on in-vivo vascular biologic mechanisms in a healthy population.~   "
85663|NCT02445768|"~     The purpose now is to:~        1. identify brain connections related to proprioception to have a better understanding of~          differences between people with stroke and healthy persons~        2. evaluate how these brain connections will change in people with stroke when they are~          engaged in 6-week cognitive multisensory rehabilitation.~   "
85664|NCT02445755|"~     The purpose of this study is to test the performance of a new transcutaneous (measured~     through skin) bilirubin device (BiliCare™) to measure bilirubin levels. The investigators~     plan to evaluate the clinical performance of this device as a point of care test. If the~     investigators can validate the BiliCare™ with bilirubin from your baby's blood they could~     verify a non-invasive alternative for measuring bilirubin.~   "
85670|NCT02445677|"~     Introduction: Chronic pain affects more than half of elderly individuals. Past studies have~     shown that pain can interfere with motor learning and rehabilitation. It was suggested that~     relieving pain before physical therapy sessions might be an interesting strategy to~     potentiate the rehabilitation of older patients suffering from pain.~      Objective: This study aims to determine if the analgesic effect induced by TENS can be used~     to maximize the rehabilitation of elderly patients suffering from chronic pain. More~     specifically, the objectives are to: 1) compare functional outcomes of patients from the Day~     Hospital receiving rehabilitation with either active TENS treatments or simulated TENS~     treatments, and 2) determine if there is an association between the analgesic effect of TENS~     and the clinical evolution of patients following their rehabilitation.~      Methods: In this RCT, patients will be assigned randomly to either the: 1) experimental group~     receiving active TENS treatments or 2) the control group receiving simulated TENS treatments.~     Thirty-six patients will be recruited according to the following criteria: 1) will receive~     physiotherapy rehabilitation at the Day Hospital of the CSSS-IUGS, 2) be at least 65 years of~     age, 3) suffering from chronic pain (pain lasting for more than 6 months), 4) presenting pain~     during the rehabilitation at the Day hospital. For security reasons, patients with a cardiac~     simulator will be excluded from the present study (TENS contraindications). Patients with~     cognitive alterations (score of < 24/30 at the Folstein test) will also be excluded.~     Sociodemographic information will be retrieved from medical records by the research assistant~     at baseline (T1). Moreover, various questionnaires will be administered at T1, after half of~     the rehabilitation period (i.e. 4 to 6 weeks) (T2), and after the 8- to 12- week~     rehabilitation period (T3) to measure the qualitative aspects of pain, mood, and physical~     function. Functional outcomes will as well be collected directly from the medical record at~     each assessment times (T1, T2 and T3).The measures include exercise tolerance, balance,~     mobility and balance, and functional ability.~      Anticipated results: We believe that: 1) use of active TENS during the rehabilitation~     sessions will potentiate rehabilitation of patients suffering from chronic pain at the~     CSSS-IUGS Day Hospital, and 2) there is a relationship between the analgesic effect induced~     by TENS and the clinical evolution of patients.~   "
85671|NCT02445664|"~     Osteoporosis is a highly prevalent disease in which non-adherence is a well-recognized~     problem. Non-adherence may be due to patients´ lack of knowledge, understanding, and~     involvement. In this study the investigators aimed to determine the effect of an educational~     video displayed on a tablet-device. The investigators hypothesized that an educational video~     would increase patients´ knowledge on osteoporosis and treatment at a two week follow up.~   "
85672|NCT02445651|"~     Parkinson's disease (PD) is a neurodegenerative disorder of unknown cause that affects more~     than a million Americans. It's most prominent pathology is the degeneration of dopaminergic~     neurons in the brain. It is believed that oxidative stress and inflammation play an important~     role in the pathophysiology of Parkinson's disease as well.~      The object of this study is to evaluate whether nutritional supplementation with compounds~     that have been shown to have either anti- inflammatory, or antioxidant effects, might support~     brain function in patients with Parkinson's disease, particularly in regards to the dopamine~     system. Enrolled patients will be randomly assigned to receive oral and intravenous n-acetyl~     cysteine (NAC), or standard PD care. This study will utilize Ioflupane (DaTscan) single~     photon emission computed tomography (SPECT) to measure dopamine function, magnetic resonance~     spectroscopy (MRS) to measure inflammatory and oxidative stress markers, and neurological~     measures to assess clinical symptoms, in patients with PD. Subjects will receive a DaTSCAN~     and MRS initially and after completing the supplement or NAC regimen.~   "
85673|NCT02445638|"~     The objective of this randomized, single blinded cross-over study is to investigate effects~     of daily egg versus yolk-free egg substitute consumption on High Density Lipoprotein (HDL)~     composition and function in a population of overweight and obese postmenopausal women.~   "
85674|NCT02445625|"~     This study aims to demonstrate that improvements in identification of social clues (and~     improvement of overall social behaviour) in subjects with ASD can be achieved using social~     games together with a BCI setup.~      The primary goal is to ensure increased rate of responses to joint attention cues.~      Intervention Type is a Device (brain computer interface using EEG). Structure: (1) initial~     eligibility screening (within 1 week after admission), (2) pre-intervention (first week of~     study, baseline outcome measures and additional evaluations), (3) intervention process (16~     weeks), (4) post-intervention (outcome measures and additional evaluations), and (5)~     follow-up (outcome measures at 6 months).~   "
85675|NCT02445612|"~     The purpose of this study is to evaluate the long term safety and tolerability of MA09-hRPE~     cellular therapy in patients with advanced Stargardt's Macular Dystrophy (SMD) from one to~     five years following the surgical procedure to implant the MA09-hRPE cells.~   "
85676|NCT02445599|"~     The purpose of the study is to examine if the hyposthesis of the preventive analgestic~     characteristic of diclofenac given preoperatively has any effect on postoperative thoracic~     wall and shoulder pain sensation. We also want to examine the rescue analgetic consumption~     and the postoperative lung function test values.~   "
85677|NCT02445586|"~     This is a Phase 4, single-arm, open-label, multicenter study to assess the safety and~     efficacy of pertuzumab in combination with trastuzumab and docetaxel for the treatment of~     participants with human epidermal growth factor receptor 2 (HER2)-positive advanced (locally~     recurrent, unresectable, or metastatic) breast cancer.~   "
85678|NCT02445573|"~     The purpose of this study is to preliminarily assess the efficacy of electroacupuncture (EA)~     for women with pure stress urinary incontinence (SUI).~   "
85679|NCT02445560|"~     The purpose of the proposed study is to determine the effects of consuming a high protein~     diet on fecal microbial communities, gastrointestinal function and symptoms, and general~     wellness in older adults.~   "
85680|NCT02445547|"~     Stem cell transplantation has emerged as a relatively popular treatment that can help to~     regulate immunity, repair injury, and control inflammation. Several studies have used~     autologous stem cells or adipose-derived stem cells to treat Crohn's disease and its~     associated complications, and have achieved good efficacy. Thus far, the use of umbilical~     cord mesenchymal stem cells (UC-MSCs) to treat Crohn's disease has rarely been reported. In~     this study, UC-MSCs were used to treat patients with hormone-controlled Crohn's disease. We~     observed the disease control conditions, corticosteroid dosage changes, and treatment-related~     adverse reactions.~   "
85681|NCT02445534|"~     Although several studies have demonstrated beneficial effects of stem cell therapy in~     patients with non-ischemic dilated cardiomyopathy, the long term benefits and predictors of~     response to therapy remain undefined. The aim of this registry is to pool long-term clinical~     data in patients with non-ischemic dilated cardiomyopathy undergoing autologous cell therapy~     in an attempt to better define predictors of response to such treatment.~   "
85682|NCT02445521|"~     The objective of this study is to test four home phenylalanine monitoring prototype devices,~     selected out of a pool of candidates by the National PKU Alliance Scientific Committee.~   "
85710|NCT02445157|"~     This study is investigating the reliability of the 4 metre gait speed test (4MGS) in patients~     with a lung disease called Idiopathic Pulmonary Fibrosis (IPF).~   "
85683|NCT02445508|"~     Accumulating evidence suggests that bile acids in our intestines may constitute essential~     components in the complex mechanisms regulating gut hormone secretion and glucose~     homeostasis. Thus, it is likely that modification of the enterohepatic circulation of bile~     acids can lead to changes in gut hormone secretion and consequently affect glucose~     homeostasis.~      The current study is a human interventional randomized controlled cross-over study including~     four study days for each participant. As a tool to sequester bile acids we will use~     sevelamer, a phosphate binding resin used in the treatment of hyperphosphataemia in adult~     patients with chronic kidney disease. Surprisingly, sevelamer has been shown to improve~     glycaemic control in patients with chronic kidney disease and type 2 diabetes. Intravenous~     infusion of cholecystokinin will be used to elicit gallbladder contraction and emptying. The~     aim is to examine how (and if) bile acid sequestration can influence postprandial~     glucagon-like peptide-1 (GLP-1) secretion and glucose homeostasis in patients with type 2~     diabetes.~      The investigators hypothesize that higher luminal concentrations of bile acids in the distal~     gut will elicit changes in gut hormone secretion. The current study will help to clarify this~     hypothesis and improve our general understanding of the association between bile acid~     circulation and signalling, gut hormone secretion and glucose metabolism.~   "
85684|NCT02445495|"~     The purpose of this study is to determine if toenail onychomycosis can be reduced by means of~     exposure to laser energy from the Cutera® GenesisPlus 1064 Nd:YAG laser system.~   "
85685|NCT02445482|"~     In recent years, the advance in high-throughput techniques, such as microarrays and next gen~     sequencing (NGS) technologies, have allowed a more precise classification of the breast~     cancer molecular subtypes and a more personalized approach to anti-cancer therapy. To date,~     conventional methods to select patients for clinical trials with anti-targeted agents~     according to molecular criteria are generally limited to the analysis of a few biomarkers.~     Recent studies have shown how this strategy is inappropriate in case of infrequent molecular~     alterations and that the ideal strategy would consist in simultaneous examination of large~     numbers of actionable genomic alterations.~      This is the first genomic screening platform ever attempted in Spain. By this molecular~     platform SOLTI aims to increase the likelihood of a patient being included in a trial~     designed specifically for her molecular tumor type. Thus, the primary objective of this pilot~     study is to determine the Platform's effectiveness to include patients in clinical trials~     with targeted agents based on the tumor molecular profiling.~   "
85686|NCT02445469|"~     Parkinsonian syndrome is clinically characterized by the presence of resting tremor,~     rigidity, bradykinesia and postural instability. Parkinsonian disorders include Parkinson's~     disease (PD), progressive supranuclear palsy (PSP), corticobasal dementia (CBD), multiple~     system atrophy (MSA) and vascular parkinsonism (VP). Each of these diseases has a singular~     physiopathological origin, course and prognosis. Numerous imaging studies consequently aimed~     at finding markers to early make the distinction between the different types of parkinsonism,~     in order to identify patients who could benefit from dopaminergic agonist therapy.~      Excessive iron deposition in the subcortical and brainstem nuclei has been described in~     numerous neurodegenerative disorders including Parkinson's disease. Increased iron levels are~     more frequent in area that are rich in dopaminergic neurons and have been implicated in the~     development of movement disorders, the distribution of areas with increased iron deposition~     however varying according to parkinsonism types. Iron deposition quantification could thus~     potentially help in differentiating parkinsonism types and could improve therapy guidance.~     Quantitative susceptibility mapping (QSM) locally estimates the magnetic susceptibility of~     brain tissues based on gradient-echo signal phase. The local susceptibility being sensitive~     to the presence of paramagnetic susbtances, QSM allows the non-invasive evaluation of iron~     distribution and quantification in the brain with high image quality (Liu et al., 2013).~     However, since iron deposition followed an exponential curve during normal aging in most of~     the basal ganglia the potential of QSM to distinguish between healthy and parkinsonian~     subjects in elderly remains unclear.~      The aim of this study was thus to determine susceptibility values in the basal ganglia of~     elderly patients with parkinsonian syndromes, to compare these values to healthy aged-matched~     controls and between parkinsonian syndrome types. Secondly, investigators aimed to evaluate~     microstructural changes in the basal ganglia using diffusion tensor imaging (DTI) in the same~     population and to determine whether susceptibility and DTI parameter changes are correlated.~     Finally investigators sought to assess the relation between susceptibility/DTI parameter~     values in the basal ganglia and behavioral measures of motor and cognitive abilities.~   "
85687|NCT02445456|"~     This study will assess whether the Sienna+/Sentimag system, which involves a magnetic tracer,~     is effective in identifying the sentinel lymph node in rectal cancer and whether it is then~     feasible to remove this lymph node during surgery to locally excise early rectal cancer.~   "
85688|NCT02445443|"~     The purpose of the current investigation is to assess the safety and efficacy of a new hinged~     revision knee device. This device is designed to provide efficient, reproducible~     reconstructions with optimal limb and implant alignment, durable implant fixation, and~     functional outcomes that increasingly approach those of primary Total Knee Arthroplasty~     (TKA).~   "
85689|NCT02445430|"~     The goal of this study is to identify genetic alterations resulting in the development of~     arteriovenous malformation (AVM) in the central nervous system.~   "
85690|NCT02445417|"~     The purpose of this study is early identification of asphyxiated newborns through eeg~     starting in the delivery room.~   "
85691|NCT02445404|"~     This study is a Randomized Phase II Study to Compare Efficacy of CHOP versus Fractionated~     ICED in Transplant-eligible Patients with Previously Untreated Peripheral T-cell Lymphoma.~   "
85692|NCT02445391|"~     This randomized phase III trial studies how well cisplatin or carboplatin (platinum based~     chemotherapy) works compared to capecitabine in treating patients with remaining (residual)~     basal-like triple-negative breast cancer following chemotherapy after surgery (neoadjuvant).~     Drugs used in chemotherapy, such as cisplatin, carboplatin and capecitabine, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. It is not yet known whether cisplatin~     or carboplatin is more effective than capecitabine in treating patients with residual triple~     negative basal-like breast cancer.~   "
85693|NCT02445378|"~     This randomized clinical trial studies aromatherapy and essential oils in improving insomnia~     and other symptoms in patients with newly diagnosed acute leukemia. Aromatherapy and~     essential oils may help improve insomnia and other complications caused by chemotherapy.~   "
85708|NCT02445183|"~     The COPDGene® / Lung Cancer Database Study is a nested case-control study. This study is an~     ancillary study to COPDGene® Phase 1 and Phase 2. Lung cancer cases, which have been reported~     by COPDGene® subjects since the time of COPDGene® study enrollment, will be retrospectively~     verified with additional medical data collection pertaining to lung cancer. Additional~     'control' subjects will also be identified and verified as a 'no lung cancer controls'. Data~     previously collected through the COPDGene® Study, including QCT results and clinical results~     (medication use, rate of acute exacerbations of COPD, etc) will be used as variables for~     analysis.~   "
85696|NCT02445339|"~     Our primary aim is to assess the feasibility of initiating treatment in the ED with~     extended-release naltrexone (XR-NTX) plus care management (CM) vs. standard care and~     continuing care in cooperation with clinic providers as well as how best to assess outcomes.~     Secondarily, the investigators will explore its effect on various health outcomes (healthcare~     utilization and engagement, expenditures, drinking and consequences, quality of life) as well~     as the association of patient-level characteristics (e.g. sex, race, baseline drinking,~     health and psychosocial factors, mu opioid receptor genotype) with effectiveness. Determining~     both how to implement XR-NTX+CM and rigorously test its effects in the ED (phase 1) is~     essential before planning a large-scale effectiveness trial (phase 2).~   "
85697|NCT02445326|"~     The objective of the study was to evaluate the efficacy and safety of OTX-DP (dexamethasone~     insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the~     treatment of the signs and symptoms of chronic allergic conjunctivitis~   "
85698|NCT02445313|"~     The investigators would like to know if different imaging devices can improve the quality of~     images and visualization of imaged tissues. Also, the investigators would like to find out~     whether these changes are useful in the diagnosis and treatment of eye diseases. Using images~     of previous participants will allow us to demonstrate the advancement of different~     technologies, as well be used to allow comparisons between current technologies.~   "
85699|NCT02445300|"~     The investigators hypothesized that AQUACEL® Ag Surgical dressing would have a significant~     improvement in the efficacy of wound care and wound complications compared with traditional~     Sofra-Tulle® dressings after minimally invasive total knee arthroplasty (MIS-TKA).~   "
85700|NCT02445287|"~     The purpose of this study is to evaluate the 2D and 3D imaging performance of the CARESTREAM~     Cone Beam Computed Tomography (CBCT) scanner (investigational device) against the~     commercially available 2D and 3D predicate devices. The results of this study will be~     included in a Traditional 510(k) FDA Submission to obtain clearance to market the new~     CARESTREAM Cone Beam Computed Tomography (CBCT) scanner in the US. The study was designed in~     accordance with the FDA Guidance titled Guidance for the Submission of 510(k)'s for Solid~     State X-ray Imaging Devices, issued on August 6, 1999.~   "
85701|NCT02445274|"~     In this study, the investigators introduce a new capsule-reserved cataract surgical~     procedure in which anterior lens capsule is reserved and attached onto posterior lens capsule~     in the purpose of preventing posterior capsule opacification (PCO). A prospective randomized~     controlled study is reported to compare the new capsule-reserved surgical procedure with~     conventional one on the effectiveness to prevent posterior capsule opacification in~     age-related cataract patients.~   "
85702|NCT02445261|"~     Women were instructed not to use the mobile phones for 24 hours before carrying out the~     initial CTG trace and Doppler ultrasound. For each patient, initial 15 minutes CTG trace~     recording was done followed by umbilical artery Doppler ultrasound using high resolution~     ultrasound unit with 3-5 MHz transabdominal transducers (General Electric logic a500, logic~     a200 City country). Thereafter, the mobile phone (type, in the dialing mode, was put on the~     mother's abdomen for 10 minutes, concurrently with repeating the 15 minutes CTG trace. The~     umbilical artery Doppler was repeated 5 minutes after hanging up to avoid the interference~     with the Doppler machine. The umbilical artery Doppler ultrasound and the recorded fetal~     heart rate (FHR) strips before and after the mobile phone use were blindly analyzed with~     respect to umbilical artery resistance indices (RI) and CTG parameters in terms of number of~     fetal kicks, absence of beat to beat variability, loss of accelerations and the appearance of~     spontaneous decelerations.~   "
85703|NCT02445248|"~     This is a multi-center, phase II study to determine the efficacy and safety of CTL019 in~     adult patients with relapsed or refractory DLBCL.~   "
85704|NCT02445235|"~     This observational study is designed to evaluate the reported outcomes for patients receiving~     topical therapy for the treatment of pain, fungal infections or skin scars. The patients will~     complete the Patient Reported Outcome (PRO) survey monthly and provide valuable data on the~     patients perception of their health status and well being while receiving therapy.~   "
85705|NCT02445222|"~     Per Health Authorities guidelines for gene therapy medicinal products that utilize~     integrating vectors (e.g. lentiviral vectors), long term safety and efficacy follow up of~     treated patients is required. The purpose of this study is to monitor all patients exposed to~     CD19 directed CAR T-cells (CD19 CART) for 15 years following last CD19 CART (e.g. CTL019)~     infusion to assess the risk of delayed adverse events (AEs), monitor for replication~     competent lentivirus (RCL) and assess long-term efficacy, including vector persistence.~   "
85706|NCT02445209|"~     The purpose of the study is to compare efficacy and safety of palliative chemotherapy EOX and~     mDCF regimens in the first-line treatment of patients with advanced HER2-negative gastric and~     gastroesophageal junction (GEJ) adenocarcinoma~   "
85707|NCT02445196|"~     PTSD Coach is a mobile application (app) that aims to teach individuals self-management~     strategies for symptoms of Post-traumatic Stress Disorder (PTSD). PTSD is a major public~     health concern. Although effective treatments exist, affected individuals face many barriers~     to receiving traditional care. As smartphones are now carried by more than half of the U.S.~     population, they have the potential to overcome many of these barriers by delivering~     self-help interventions on apps. Despite PTSD Coach's use of evidence-based cognitive~     behavioral strategies there is still a need to test the effectiveness of the app in managing~     PTSD symptoms. This controlled, two-arm, randomized (1:1) trial will evaluate the efficacy,~     feasibility and acceptability of PTSD Coach to reduce PTSD symptoms in a community sample of~     trauma survivors with PTSD symptoms. After completing an eligibility phone screen or online~     screen, individuals who score a 35 or above on the PTSD Checklist (PCL) and consent will~     complete a baseline assessment and then be randomized to the PTSD Coach app condition or a~     waitlist control group. Additionally, those assigned to the PTSD Coach intervention will be~     instructed to download a research version of the app, called PTSD Explorer, that enables~     passive and objective monitoring of app use. Each individual will be reassessed at~     post-intervention (3 months) and follow-up (3 months later, or 6 months after completing~     baseline). The investigators predict that those using the PTSD Coach app will demonstrate a~     significant and sustained reduction in PTSD symptoms and increase in patient coping~     self-efficacy compared to the waitlist control group. The investigators will explore if there~     is a relationship between levels of engagement and PTSD symptom change.~   "
85711|NCT02445144|"~     Patients with sickle cell anemia (SCA) are at an increased risk for damage to brain tissue~     due to their disease. The investigators are interested in how blood flow and cerebral~     inflammation are different in SCA patients and how that affects brain tissue- the~     investigators will use a relatively new set of dynamic MRI techniques to evaluate these~     parameters. The investigators will image participants with both SCA and matched controls with~     non-invasive MRI.~   "
85712|NCT02445131|"~     The CLL2-BCG-trial is a prospective, open-label, multicenter phase-II-trial to evaluate the~     efficacy and safety of a sequential regimen of a debulking with bendamustine followed by an~     induction with GA101 (obinutuzumab) and CAL-101 (idelalisib) followed by CAL-101 and~     GA101-maintenance in CLL patients~   "
85713|NCT02445118|"~     This is a 16 week pilot study to assess short term outcomes of an injectable allograft~     adipose matrix (AAM) in the subcutaneous space in the dorsum of the wrist. A total of 30~     patients will be enrolled at 2 sites and will be followed for sixteen weeks. Volume retention~     and local skin changes will be observed and documented prior to and following injection at~     week 0 and at follow up visits at 2, 10 and 16 weeks. Evaluations will be done via~     photographic analysis at week 0,2,10 and 16 weeks and half of the patients will undergo~     magnetic resonance imaging at week zero and at week 16. The dominant wrist will serve as a~     control and will receive no injection. Analysis includes volume retention, tissue analysis,~     local skin changes and adverse events, if any.~   "
85714|NCT02445105|"~     This multisite study will compare the effectiveness of universal screening by 3 community~     service systems using Autism Navigator, a highly interactive web platform that includes an~     automated screening tool, information about autism for families, and a professional~     development course on the early signs of autism and effective evidence-based practice with~     extensive video footage to rapidly build the capacity for early detection. The investigators~     will also conduct a multisite pragmatic randomized clinical trial to test the effectiveness~     of an evidence-based Family Engagement Intervention compared to Autism Navigator Enhanced~     Practice implemented by the 3 community service systems with children who have a positive~     autism screen to increase the number of children who are screened, referred for evaluation,~     receive a diagnosis, and receive community-based EI between 18-27 months of age. This study~     will impact family engagement in community screening and diagnosis by demonstrating the~     effectiveness of brief manualized engagement interventions. Findings will advance science by~     providing researchers with a method for recruiting a community sample, allowing for research~     at younger ages, which could accelerate science.~   "
85715|NCT02445092|"~     The investigators hypothesize that washing the insemination catheter prior to performing the~     IUI (intrauterine insemination) will improve the pregnancy outcome in IUI cycles when~     compared to controls (without pre-washing the catheter).~      Catheter washing is performed routinely before embryo transfer, however it is not done for~     IUI catheters. Therefore no data is available on applying the technique to IUI catheters~     prior to insemination.~   "
85716|NCT02445079|"~     Longitudinal cohort study of older-aged people living with HIV infection in southwestern~     Uganda and age and gender-matched HIV uninfected controls with the primary aim of measuring~     the epidemiology of cardiovascular and pulmonary disease in this study setting, and~     particularly the contribution of HIV infection to it.~   "
85717|NCT02445066|"~     This pilot study is a 4-month open label trial in 15 older (65-89 yrs) men and women with~     initial 25(OH)D concentrations of 12-<18 ng/mL to explore the effect of increasing 25(OH)D~     concentrations to ≥30 ng/mL through vitamin D3 supplementation on changes in mitochondrial~     bioenergetics. We will assess the bioenergetic profile of blood cells isolated mitochondria,~     and muscle fibers as well as the expression of mitochondrial proteins and regulators of~     mitochondria biogenesis before and after supplementation. All participants will be given~     vitamin D3 (4,000 IU/d) for 4 months.~   "
85718|NCT02445053|"~     To describe the effectiveness of Kalydeco® treatment in patients with cystic fibrosis (CF)~     who have 1 of 8 non G551D gating CFTR mutations (G178R, S549N, S549R, G551S, G1244E, S1251N,~     S1255P, or G1349D).~   "
85719|NCT02445040|"~     The purpose of this study is to determine the safety and effectiveness of the Babylog VN500~     in high frequency oscillatory ventilation (HFOV) mode as a method for treating very low birth~     weight (VLBW) neonates requiring invasive respiratory support in the treatment of respiratory~     distress.~   "
85720|NCT02445027|"~     The goal of this study is to test the feasibility and acceptability of tethered capsule~     Optical Coherence Tomography (OCT) endomicroscopy as a device for population-based screening~     in the primary care practice environment.~   "
85721|NCT02445014|"~     The goal of this research is to test the feasibility and tolerability of the modified, larger~     diameter, tethered Spectrally Encoded Confocal Microscopy (SECM) capsule in healthy subjects,~     subjects with Barrett's Esophagus (BE), and subjects with Gastroesophageal reflux disease~     (GERD). This information will be used to assess optimal imaging technique, imaging quality,~     and subject tolerability.~   "
85722|NCT02445001|"~     Instead of the usual procedure of injecting ICG dye directly into an arm vein, now the dye~     can be placed inside of RBCs. When a small volume of the RBC's with the dye is injected into~     a person's arm, the individual RBCs can be seen as they flow through the retinal blood~     vessels.~   "
85723|NCT02444988|"~     The administration of intravenous fluids is ubiquitous in the care of the critically ill.~     Commonly available isotonic crystalloid solutions contain a broad spectrum electrolyte~     compositions including a range chloride concentrations. Recent studies have associated~     solutions with supraphysiologic chloride content with hyperchloremia, metabolic acidosis and~     renal vasoconstriction, acute kidney injury and renal replacement therapy, and increased~     mortality but no large, randomized-controlled trials have been conducted. SMART-MED will be a~     large, cluster-randomized, multiple-crossover trial enrolling critically ill patients from~     the Medical ICU at Vanderbilt University from June 2015 until April 2017. The primary~     endpoint will be the incidence of Major Adverse Kidney Events in 30 days after enrollment~     (MAKE30 is the composite of death, new renal replacement, or persistent renal dysfunction at~     discharge).~   "
85724|NCT02444975|"~     The purpose of this study is to determine whether increased water intake is effective in~     preventing episodes of uncomplicated urinary tract infections (UTI) in pre-menopausal women~     suffering from UTI recurrences.~   "
85725|NCT02444962|"~     At the department of Cranio-Maxillofacial Surgery, Maastricht University Medical Center~     (MUMC) the routine procedure after ablation of the nose, ear or eye is reconstruction with an~     episthesis. Retention can be achieved using adhesives, undercuts or bone implants. Implant~     based episthesis are now commonly used because of the good retention and episthesis~     stability. This results in a better patient quality of life.~      Today we use machined surface implants in the craniofacial region of different brands. Each~     system has its own instruments and application method. To enhance the clinical usability, we~     are searching for one system for all extra-oral implant regions.~      Furthermore, implant patients may be compromised by aging, diseases, smoking, medication and~     radiation therapy, which can affect the bone healing process. In these cases, implants are~     known to have higher failure rates compared to the application in healthy cases. Therefore~     implants with biomechanical surface modifications, such as the HAVD implants of BioComp, may~     have a positive effect on osseointegration, resulting in higher success rates in the~     compromised patient.~      The aim of this pilot study is to collect information about the functionality and safety of a~     surface treated implant system (HAVD, BioComp) for episthetic reconstruction after ablative~     surgery in the nasal, orbital and auricular region for a potential future RCT.~   "
85726|NCT02444949|"~     Among all the head and neck tumors, nasopharyngeal carcinoma (NPC) has a high tendency of~     recurrence and metastasis. For the advanced NPC patients, chemoradiotherapy is the main way~     of treatment. Currently, chemotherapy with cisplatin (DDP) combines with 5-fluorouracil~     (5-FU) is the classic front line therapy for NPC. However, the abnormal richness of~     angiogenesis of tumor and blood supply in tissue caused by radiation therapy often decrease~     the effects of radiochemotherapy. Human recombinant vascular endothelial inhibitor (endostar)~     can improve the sensitivity to chemoradiation via selectively inhibiting the migration of~     endothelial cells and the formation of tumor vessels. Moreover, it would induce vascular~     remodeling and normalization of the tumor vasculature, which will effectively aid the~     delivery of oxygen and anticancer drugs. In sum, antiangiogenesis in combination with~     chemoradiotherapy will be a promising way of treatment for NPC. In this study, the~     first-treated patients with NPC (stage Ⅲ or Ⅳa) confirmed by pathology, and patients with~     recurrent and metastatic NPC will be randomly assigned to two groups (1:1): a trial group~     (DDP, 5-FU, endostar and sequential intensity modulated radiation therapy (IMRT)), and a~     control group (DDP，5-FU and sequential IMRT). Evaluations will be developed including~     progression-free survival (PFS), Overall response rate（ORR）, overall survival (OS), adverse~     effects rate and quality of life. This research will provide more evidences of evidence-based~     medicine for the safety and tolerability of endostar and the clinical application of endostar~     in NPC treatment.~   "
85727|NCT02444936|"~     This study evaluates if the shingles vaccine works in those persons that receive it before~     they receive chemotherapy for solid organ tumors. Half of the participants will receive the~     ZOSTAVAX shingle vaccine and half of the participants will not received anything.~   "
85728|NCT02444923|"~     The most common causes for irregular cornea (IC) in hospital contact lens practice are~     Keratoconus (KC) and related cornea thinning disorders. These conditions cause mild to marked~     impairment of vision and cannot be effectively corrected by spectacles and soft contact~     lenses. The gold standard in the management of KC is Corneal Rigid Gas Permeable contact~     lenses (corneal lenses), which correct approximately 90% of the corneal irregularity.~      Compared with a normal cornea, the cornea in KC is irregular and this results in a compromise~     to the fit of rigid corneal lenses. Specifically, they bear on the cornea and this, together~     with the vulnerability of the cornea in KC, are implicated in corneal scarring, and disease~     progression as well as a significantly reduced vision related quality of life (QoL) in KC~     compared with corneal lens wearers who have no KC.~      In cases where the compromise fit of corneal lenses proves problematic, large diameter~     Scleral RGP contact lenses (scleral lenses) may be used as a problem solver. Unlike the~     smaller corneal lenses which bear on the cornea, the scleral lenses completely bridge over~     the cornea and bear on the sclera.~      The aim of this research is to investigate the performance of scleral lenses in KC~     participants who habitually wear corneal lenses.~      The research question: is there a measurable difference in the visual performance and visual~     quality of life in participants with Irregular cornea disorders like keratoconus and other~     related conditions, who habitually wear corneal lenses in comparison with scleral lenses.~   "
85729|NCT02444910|"~     KDT501 is an orally administered product designed to help control impaired glucose and~     insulin regulation in patients with insulin resistance. Nonclinical studies demonstrate~     agonist activity of KDT501 at the G-protein coupled receptor 120 as well as other G-protein~     receptors. Nonclinical studies have also documented the ability of KDT501 to improve insulin~     sensitivity and glucose regulation as well as reduce proinflammatory signals. These~     properties combined with antihyperglycemic activity and modest, partial agonist effect of~     KDT501 at the peroxisome proliferator-activated receptor-gamma (PPARγ) receptor suggests an~     atypical and pleiotropic mechanism of action for KDT501.~      Following providing informed consent, potential subjects will undergo screening procedures to~     ensure that they meet all inclusion and exclusion criteria. Following registration on study,~     subjects will undergo baseline pretreatment studies, including two abdominal fat biopsies,~     one taken after cold challenge, as well as determination of resting metabolic rate, a 4 hour~     lipid tolerance test, and a 2 hour euglycemic clamp study. All pretreatment studies in~     registered subjects will be performed within 7 days prior to initiating therapy. On the first~     day of treatment (Day 0), subjects will take the first 600 mg dose of KDT501 in the clinic,~     followed by serum pharmacokinetic (PK) samples being obtained every hour for 6 hours after~     dosing. Subjects will then continue dosing as an outpatient, 600 mg po twice daily. All doses~     will be taken with meals (breakfast and dinner). On Day 7, subjects will return to the clinic~     to undergo safety and laboratory assessments, including PK. On Days 14 and 21, subjects will~     again return to the clinic to undergo safety and laboratory assessments. On Day 17 subjects~     will return to the clinic for PK studies, as noted below. Treatment in all subjects will end~     on Day 28. Rapid PK assessment of drug exposure, defined as AUC0-12h, will be performed~     following PK samples drawn at Time 0, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, and 12h on both Days 7~     and 17. On Days 11 and 21 (±1day), based on the KDT501 drug exposure level, the subject will~     be provided instructions on dose adjustments of KDT501. The maximum allowed KDT501 exposure~     ceiling for all subjects enrolled is AUC0-12h = 22,500ng-hr/mL.~   "
85730|NCT02444897|"~     This study was designed to assess the effectiveness of epidural patient-controlled analgesia~     compared to intravenous patient-controlled analgesia in patients undergoing laparoscopic~     gastrectomy. The investigators hypothesized that epidural PCA would be more effective in pain~     control than IV PCA even for laparoscopic gastrectomy.~   "
85731|NCT02444884|"~     RATIONALE: MLN8237 may stop the growth of cancer cells by blocking some of the enzymes needed~     for cell growth.~      PURPOSE: This phase I/II trial is studying the side effects and best dose of MLN8237 and to~     see how well it works in treating young patients with relapsed or refractory solid tumors~   "
85732|NCT02444871|"~     The purpose of this study is to evaluate the effect of IgM-enriched immunoglobulins~     (Pentaglobin) on the endotoxin activity, conventional coagulation parameters, viscoelastic~     and aggregometric measurements of patients with severe sepsis.~   "
85733|NCT02444858|"~     Phase I-II Clinical Trial-Safety and efficacy of umbilical-cord-derived mesenchymal stem cell~     (UC-MSC) in patients with paraquat poisoning induced lung injury, randomized,single blind,~     controlled prospective study.~   "
85734|NCT02444845|"~     The purpose of this study is to evaluate the prevalence of CKD-related anemia at an early~     stage through screening of high-risk patients in Pakistan at the level of physicians,~     cardiologists, and diabetologists. The information gathered may serve as a foundation in~     formulating national guidelines for better early diagnosis and management of patients with~     CKD.~   "
85735|NCT02444832|"~     Based on the anatomical features of the anterior Communicating artery complex, the~     investigators will analyze the outcome of the ACoA aneurysms treated by endovascular therapy.~      The most common site of intracranial aneurysms is the anterior communicating artery (AcomA).~     AcomA aneurysms account for approximately one-fourth of all intracranial aneurysms.~      Recent publications have addressed specifically the endovascular treatment of AcoA aneurysms.~     Furthermore, detailed anatomic characteristics and the effects of the multiple variations of~     the anterior communicating artery complex have scarcely been reported.~      The hemodynamic factors play a fundamental role in the adequate treatment of aneurismal~     coiling.~      The objective of our registry is to analyze the impact of morphological configuration of the~     anterior communicating artery complex and the results of coil embolization in AcoA aneurysms~   "
85736|NCT02444819|"~     A multi-center, single-arm. Phase 2 exploratory trial to evaluate the efficacy and safety of~     HM61713 as the 1st-line anticancer agent in none-small cell lung cancer patients with EGFR~     mutation~   "
85737|NCT02444806|"~     The study aims to compare 2 different strategies used to setup non-invasive ventilation in~     patients with OCPD-OSA overlap.~   "
85738|NCT02444793|"~     This study is a Phase 1b, open label, multi center, multi-dose trial designed to estimate the~     maximum tolerated dose (MTD) and select the recommended dose for phase 2 (RP2D)~     investigations of PF- 05082566 in combination with KW-0761 (mogamulizumab) in patients with~     advanced solid tumors. Once the MTD of PF-05082566 administered in combination with KW-0761~     is estimated (dose finding), one or more expansion cohorts of patients with selected advanced~     solid tumors (dose-expansion ) will be enrolled to further characterize the combination in~     term of safety profile, anti tumor activity, pharmacokinetics, pharmacodynamics and~     biomarkers modulation.~   "
85739|NCT02444780|"~     Earlier studies showed that a low glutamine level at acute admission on the ICU is associated~     with a poor outcome [3,4]. Recently, we found that a low plasma glutamine is correlated with~     severity of illness and presence of an infection after non-elective ICU admission [5,~     submitted].~   "
85740|NCT02444767|"~     The Bimatoprost Ocular Insert is intended to provide sustained delivery of bimatoprost to the~     ocular surface to lower the intraocular pressure (IOP) in patients with open-angle glaucoma~     or ocular hypertension.~      This study will evaluate the pharmacokinetic aspects of the Bimatoprost Ocular Insert in~     healthy (non-glaucoma) subjects.~   "
85741|NCT02444754|"~     This pilot research trial studies minority patients receiving care at the Comprehensive~     Cancer Center of Wake Forest University (CCCWFU) to see what their attitudes are regarding~     the healthcare they receive and how much they know about clinical trials. Clinical trials are~     an important way to test healthcare treatments and need diverse participants to be most~     effective. Studying what minority patients think about healthcare and clinical trials may~     help researchers learn more about why minorities are less likely to enroll in clinical trials~     and create programs to help increase their enrollment.~   "
85742|NCT02444741|"~     The goal of Phase 1 of this clinical research study is to find the highest tolerable dose of~     the combination of Keytruda (pembrolizumab, also called MK-3475) and radiation therapy~     (either conventional or stereotactic body radiation therapy [SBRT]). The safety of this~     combination will also be studied.~      The goal of Phase 2 of this study is to learn if this combination therapy can help to control~     metastatic NSCLC.~      This is an investigational study. Radiation therapy (both conventional and SBRT) is FDA~     approved for the local control of metastatic and primary tumors. Pembrolizumab is FDA~     approved and commercially available for the treatment of melanoma that is metastatic or~     cannot be removed by surgery. Its use in patients with metastatic NSCLC is investigational.~      Up to 104 participants will be enrolled in this study. All will take part at MD Anderson.~   "
85743|NCT02444728|"~     Treating severe thrombocytopenia is a challenge in the management of systemic lupus~     erythematosus. Although rheumatologists have followed some rules in real practice,there is~     very few evidence to support the current treatment algorithm. The purpose of this study is to~     compare the complete remission rate and partial remission rate of cyclophosphamide and~     hydroxychloroquine for treating severe thrombocytopenia in Chinese SLE patients.~   "
85744|NCT02444715|"~     Stroke is one of the most frequent and life-threatening diseases in Europe. About four stroke~     events occur per day in Luxembourg alone, and about 30% of these patients are affected by~     recurrent stroke within the following five years. Thus, new methods of primary and secondary~     prevention are needed to better control lifestyle-related risk factors.~      The development and maintenance of a healthy lifestyle (smoking cessation, healthy nutrition,~     moderate physical exercises etc.) is a major objective concerning the primary and secondary~     prevention of cerebro- and cardiovascular diseases. CAPSYS is a computer-based lifestyle~     coaching system developed by researchers from the Public Research Centre (CRP) Henri Tudor in~     Luxembourg in collaboration with neurologists from the Centre Hospitalier de Luxembourg~     (CHL), which aims at supporting patients in performing appropriate behavior changes in order~     to minimize their individual risk factors. Patients can access CAPSYS by dialing a local-rate~     telephone number and answer to a set of previously known questions concerning their current~     nutrition, physical activity, blood pressure, smoking etc. In an interactive voice response~     approach, questions are issued by the system in natural language using text-to-speech, and~     the patient can provide the required values using the phone keypad. Based on the gathered~     values for each patient, the system automatically generates personalized verbal feedback at~     runtime and presents it to the patient during the phone dialog. Depending on the individual~     development of the patient's risk factors, the system feedback can contain advice for~     improvement, praise for healthy behavior and motivation to pursue a certain goal.~      The user acceptance and effectiveness of the CAPSYS system is evaluated in a six-month~     randomized controlled study with participants recruited at CHL's neurology department.~   "
85986|NCT02441543|"~     Preclinical studies and clinical observations have shown the Phosphoinositide 3-kinase (PI3K)~     /Protein kinase B (AKT) /mammalian (mechanistic) target of Rapamycin (known as the~     'mTOR-pathway') signaling to be deregulated in several tumors.~   "
85745|NCT02444702|"~     The long term goal of this project is dual fold. First, the investigators wish to derive,~     validate and then test the impact of a clinical prediction rule to determine which patients~     who suffer from CLBP with degenerative changes of the lumbar spine and referred pain to the~     legs are likely to require surgery and have successful outcomes in the long term. Second, the~     investigators would like to establish robust methodology and statistical analysis guidelines~     for creating clinical prediction rules in physical therapy research. This observational~     cohort project is a first step towards those goals. Here the investigators specifically aim~     to identify personal, behavioral, psychological, morphological, and physical factors that can~     predict the need for surgery as well as level of participation restriction in patients who~     suffer from CLBP with degenerative conditions of the lumbar spine and referred pain to the~     legs. The investigators will also explore which parameters can predict success after 1 month,~     6 and 12 months in patients who underwent decompression/fusion surgery.~   "
85746|NCT02444689|"~     The purpose of this study is to evaluate the effectiveness of a technology-based behavioral~     Healthy Lifestyle intervention on adiposity (body mass index z-score), blood pressure (mean~     clinic systolic BP), and heart size (LVM) in comparison to standard care.~   "
85747|NCT02444676|"~     Background: Heart failure (HF) is in many cases the final way for coronary heart diseases. In~     older than 65 years is the most important cause of hospitalization. Many studies have~     analyzed the causes of decompensation and the possible causes of hospital re-admission but~     most evidences come from the hospital setting. Nevertheless, It is known that many of these~     patients are usually attended in primary care setting, being treated by their General~     Practitioner and are not referred to the hospital.~      The determinants which condition whether stable HF patients will be hospitalized as a~     consequence of a decompensation remain still unclear.~      Objective: To develop and validate a predictive model based on clinical variables easy to~     measure at primary care to predict short-term hospitalization or mortality in a cohort of~     patients attended in primary care setting as a consequence of a HF decompensation.~      Methods: A cohort of patients with established HF attended in primary care setting (regular~     care or out of hours) as a consequence of an episode of HF decompensation will be follow up.~     To develop the predictive model we will select variables which previously have been found~     involved in the risk of hospitalization or mortality as a consequence of HF as well as other~     ones which could be relevant and have not been studied yet. Variables selected should be~     easily determined in primary care setting..~      The predictive model obtained in the derivation cohort from Spain will be validated in an~     external (several European countries) validation cohort.~      Relevance: Our study will help GP to identify HF patients at higher risk of hospitalization~     or death and manage them according to an accurate prognostic rule (escala pronostica) made in~     primary care setting.[DISCUTIR]~   "
85748|NCT02444663|"~     X-rays are the most frequently used imaging test when evaluating the knee for joint~     replacement. They are non-invasive, safe and cost effective. They allow assessment of:~     progression of disease, appropriateness for joint replacement (in particular unicompartmental~     knee replacement (UKR)) as well as likely prognosis following replacement.~      Currently standard assessment involves: standing anteroposterior, lateral and skyline X-ray~     views. In addition in patients being considered for joint replacement valgus/varus stress~     X-rays are used to evaluate the lateral compartment (as well as medial collateral ligament)~     and medial compartment respectively to assess the status of the cartilage. Stress X-rays~     require the clinician to attend X-ray, often during busy clinics, exposing them to additional~     radiation, and as such they are seldom performed.~      A patient and user friendly device for performing valgus and varus stress X-rays of the knee~     for diagnostic and pre-operative planning purposes in the setting of knee replacement surgery~     has been developed. This device has the potential to benefit patients as it will allow an~     accurate assessment of the pattern and severity of arthritis affecting their knee without the~     need for additional diagnostics such as MRI or arthroscopy. Furthermore for healthcare~     practitioners and providers this device will facilitate the smooth running of clinics and~     reduce the additional clinic appointments required to review MRI results. Ultimately this~     device will allow an informed discussion about treatment options, reduce the pre-operative~     uncertainty about suitability for UKR in those undergoing surgery and ensure that those~     patients who are suitable for UKR benefit from this procedure. This device will help ensure~     that patients receive the optimum treatment in a clinically and cost efficient manner.~      This study will validate valgus and varus stress X-rays performed using the investigators'~     device against the gold standard of clinician performed manual stress.~   "
85749|NCT02444650|"~     Optically-based data will be compared to tonometry to determine correlation of pulse wave~     velocity measurement.~   "
85750|NCT02444637|"~     Rivastigmine, an acetylcholinesterase inhibitor which has been approved by FDA & HSA, is~     authorized for use in the treatment of mild to moderate dementia of the Alzheimer's type.~      In this trial, the investigators will be studying the effectiveness of Rivastigmine in~     subjects with AD and cerebrovascular disease.~   "
85751|NCT02444624|"~     The clinical study involves a French network of 20 neonatology centres created as part of the~     EPIFLORE project. Investigators propose including all premature babies with confirmed~     necrotizing enterocolitis (NEC) diagnosis (Bell stage II or III) paired with a control group~     of healthy premature babies, over a 2-year period. The clinical data will be entered at~     inclusion until departure from the department, and the ASQ (Ages and Stages Questionnaires)~     will be collected after 24 months. Samples from NEC cases and from the control group will be~     submitted for microbiological testing by culture and pyrosequencing. This will enable the~     main aerobic micro-organisms in the dominant and subdominant intestinal microbiota to be~     isolated. This case-control study will be used to compile a collection of clinical and~     microbiological data, in order to confirm the role of bacteria in the pathophysiology of NEC,~     and to confirm the involvement of bacteria from the Clostridium genus in particular.~   "
85762|NCT02444481|"~     Open prospective multicenter phase IV study in patients presenting with symptoms of bacterial~     and/or mycotic (mushroom) vaginitis for 12 days as specified in the product information.~      Investigators/centers: 20 gynacologists are previewed to do the study in ambulatory~     treatment.~      Objectifs of the study:~      Principal objectif:~      Evaluation of the efficacy of the treatment on the clinical symptoms of bacterial and/or~     mycotic vaginitis~      Secondary objectif:~      Evaluation of the efficacy of the treatment on eradication of the diagnosed germs Evaluation~     of the correspondence of the efficacy on the symptoms and on the eradication of the germs.~      Numbers of patients previewed: 100 patients for evaluation of the efficacy~      Criteria of evaluation~      Principal criteria:~      Clinical efficacy as judged by the investigator Secondary criteria:evaluation of clinical~     symptoms judged by the patient reduction or emlimination of bacteria and other germs the~     relationship between clinical and bacterial results~      Evaluation of tolerance~      Used Study Drug:~      Polygynax, vaginal capsule consisting of Polymyxin 35000 UI, Neomycin 35000UI and Nystatin~     100000UI Application: vaginal application once daily in the evening for 12 days~      Study design:~      Visit 1:~      All patients presenting with the clinical symptoms, presenting all inclusion criteria and~     none of the exclusion criteria are included in the study at visit 1 and receive Polygynax~     treatment (one vaginal capsule once daily in the evening).~      A vaginal smear is obtained. Visit 2 (optional) If the results of the bacteriological~     examination confirms an infection with germs sensible to the treatment with Polygynax the~     treatment is continued. If other germs not sensible to Polygynax are present, the patients is~     contacted to stop the treatment, to come back to a second visit to her gynacologist who will~     change the treatment. The other patients continue the treatment.~      Visit 3:~      After the treatment the patients come back to the last visit. A clinical evaluation and a~     vaginal smear for control is obtained.~   "
85997|NCT02441400|"~     To provide a research tool enabling physicians to monitor long term clinical outcomes for~     patients undergoing gastroesophageal reflux disease (GERD) treatment with EndoStim LES~     Stimulation System.~   "
85752|NCT02444611|"~     Neonatal morbidity and mortality from infectious diseases is of global concern. Childhood~     disease-specific immunisation is irrefutably linked to the decline in deaths from these~     targeted infections over the last century. However, neonatal immunisation is limited, in~     part, by the impaired adaptive immune function in this age group.~      There is now an expanding body of evidence for heterologous ('non-specific') effects of~     various vaccines used in childhood. This refers to the immunomodulatory capabilities of~     vaccines to influence immune outcomes beyond the vaccine's specific targeted disease. The~     underlying immunological mechanisms responsible for these effects are incompletely~     understood, but evidence is mounting that the innate immune system is central to these~     observed effects.~      This study is a randomised controlled trial designed to determine the influence of two~     commonly administered neonatal immunisations, BCG and Hepatitis B vaccine, given at birth, on~     the neonatal immune responses to non-specific antigens.~      The investigators will recruit 200 newborns at the Mercy Hospital for Women in Melbourne,~     Australia over a 1-year period. These babies will be allocated randomly to one of 4 groups,~     receiving these 2 vaccines in different combinations, at 2 set time points. (at birth and 1~     week post randomisation) A blood sample will be taken at 1-week post randomisation for in~     vitro immunological analyses.~      This study will improve current understanding of the influence of vaccines on neonatal~     immunity and will help develop strategies exploiting beneficial heterologous ('non-specific')~     effects to improve protection against infection in the very young.~   "
85753|NCT02444598|"~     There is a treatment method called negative-pressure wound therapy (NPWT) that is well~     established and used for the treatment of wounds. The method involves the application of a~     wound dressing through which a negative pressure is applied. Due to a plastic film overlaying~     the wound the risk of wound contamination is reduced. NPWT is considered to promote wound~     healing and prevent infection and has previously been used in the treatment of acute war~     associated wounds with satisfactory results. The aim of this study is to compare NPWT with~     conventional wound dressings in the treatment of war-associated extremity wounds and evaluate~     which method is more effective.~   "
85754|NCT02444585|"~     The overall objective of the proposed study is to quantify bone loss around non-cemented~     total hip replacement femoral and acetabular components using DEXA analysis in patients~     receiving Prolia (denosumab) in the first year of follow up after total hip joint replacement~     surgery, and to compare this to bone loss in control hip replacement patients receiving a~     placebo.~      The primary outcome variable will be the difference in loss of bone mineral density between~     the experimental group taking denosumab and the placebo control group, calculated as a~     percentage, in Gruen Zone 7, the proximal medial calcar region of the femur, over a follow-up~     period of 12 post-operative months.~      The secondary objectives will be to assess the following variables:~        -  Bone turnover differences between the experimental group taking denosumab and the~          placebo control group, utilizing serum C-terminal cross-linking telopeptides of type I~          collagen (CTX-I) (bone resorption) and N-terminal propeptides of type I procollagen~          (P1NP) (bone formation).~        -  Difference in loss of bone mineral density between the experimental group taking~          denosumab and the placebo control group, calculated as a percentage, in each of Gruen~          Zones 1 through 6, periprosthetic femur.~        -  Difference in loss of bone mineral density between the experimental group taking~          denosumab and the placebo control group, calculated as a percentage, in each of DeLee~          and Charnley's Zones 1 through 3, periprosthetic acetabulum.~      Exploratory objectives will be to assess difference in loss of bone mineral density in the~     contralateral, or non-operated femur for both experimental and control groups, and to~     determine the role that covariates such as weight, gender, age, baseline BMD, and implant~     type have on percent change in BMD at 12 months.~   "
85755|NCT02444572|"~     Comparison of thromboembolic events between Enoxa® and Lovenox® in patients undergoing~     digestive cancer and subjected to thromboprophylaxis.~   "
85756|NCT02444559|"~     The aim of this trial is to investigate if clonidine prolongs the duration of an adductor~     canal block. By using healthy volunteers the investigators can perform a bilateral adductor~     canal block and thereby control for a systemic effect to clarify if the effect is actually~     peripheral or systemic. The investigators hypothesis is that clonidine/dexmedetomidine as an~     adjunct to a local anaesthetic prolongs the duration of a peripheral nerve block by a~     peripheral mechanism.~   "
85757|NCT02444546|"~     This phase I trial studies the side effects and the best dose of wild-type reovirus (viral~     therapy) when given with sargramostim in treating younger patients with high grade brain~     tumors that have come back or that have not responded to standard therapy. A virus, called~     wild-type reovirus, which has been changed in a certain way, may be able to kill tumor cells~     without damaging normal cells. Sargramostim may increase the production of blood cells and~     may promote the tumor cell killing effects of wild-type reovirus. Giving wild-type reovirus~     together with sargramostim may kill more tumor cells.~   "
85758|NCT02444533|"~     The purpose of this study is to determine whether liposomal bupivacaine (long acting~     injectable anesthetic) provides greater post operative pain relief compared to the standard~     post operative pain regiment for tonsillectomy patients.~   "
85759|NCT02444520|"~     PRINCE primary is cluster randomised waiting list controlled trial to evaluate the~     acceptability and feasibility of studying an integrated approach to care in general practice~     for adults with persistent physical symptoms (PPS). PPS is defined as physical symptoms with~     no obvious underlying organic cause (Dreary, Chalder and Sharpe, 2007; Stone, 2009). In the~     intervention arm GPs practices will be offered training in 10-minute cognitive behavioural~     therapy (CBT), a therapy that aims to address unhelpful behaviours and beliefs. Participants~     will also be given self-help materials which include a series of leaflets and an animation~     describing a patients experience with chronic pain. The systems approach will be compared~     with a waiting list.~   "
85760|NCT02444507|"~     To assess the bioequivalence of esomeprazole of the TEST product vs. the REFERENCE product in~     healthy volunteers who reside in Taiwan.~   "
85761|NCT02444494|"~     The objective of this non-interventional study is to evaluate clinical effectiveness and cost~     effectiveness of Dysport within the reimbursement scheme called drug programme funded by~     Polish National Health Fund (NHF) for patients with post stroke ULS. The study is designed to~     collect data in patients scheduled to receive Dysport treatment in a drug programme, based on~     routine treatment of subject with ULS.~   "
85763|NCT02444468|"~     This study investigates, in a randomized setting, the use of intermittent in-cast pneumatic~     foot-compression (IPC) in the preoperative treatment of malleolar fractures. This is to~     investigate whether the IPC has any effect on preventing swelling of the ankle, and thereby~     preventing delay of surgery due to swelling.~      The investigators will include patients with malleolar fractures that require surgery in two~     groups, IPC and bandage or bandage only, and measure the time from diagnosis-to-surgery.~   "
85764|NCT02444455|"~     Phase I-II Clinical Trial - Safety and efficacy of umbilical-cord-derived mesenchymal stem~     cell (UC-MSC) in patients with Acute Lung Injury ,open label, controlled prospective study.~   "
85765|NCT02444442|"~     The purpose of this study is to assess the efficacy catheter-based renal denervation in~     reducing blood pressure in patients with resistant hypertension compared to a sham procedure.~     Patients will be randomized to RDN or sham control in a 2:1 ratio. All participants will be~     switched to a single pill triple combination treatment prior to the procedure.~      A total of 105 patients will be recruited into the study, 70 patients in the RDN arm and 35~     patients in the sham control arm.~      The duration of this study is 36 months.~   "
85766|NCT02444429|"~     Renal transplantation represents currently the best therapeutic alternative for end-stage~     renal failure, not only in terms of patient outcomes (better quality of life and longer~     survival), but also in terms of costs for the society.~      Progress achieved in the last 20 years has resulted in a drastic reduction of the incidence~     of classic (i.e. clinically patent) acute cellular rejection episodes.~      Unfortunately, and rather unexpectedly, this progress has had hardly any effect on the~     frequency of the loss of kidney transplants beyond the first year, as shown by the stagnation~     of grafts' half lives.~      Furthermore, the use of immunosuppressant combinations that are more and more powerful has an~     impact on adverse effects in recipients, including an increased incidence of infections,~     cancers, but also metabolic complications (diabetes, osteoporosis, dyslipidemia, etc.), which~     are cause of significant morbi-mortality.~      In an attempt to improve on these disappointing outcomes, some teams have offered to perform~     screening biopsies: i.e. routine biopsies at specific time points during the follow up,~     irrespective of graft function. Their primary interest is to allow a pathological analysis of~     the graft at an early stage, i.e. when potential histological lesions allow for a diagnosis~     but before these lesions impact on graft's function. Indeed, it has been clearly demonstrated~     that therapeutic adjustments intended to protect the grafts are most effective when~     introduced early. There is a fairly broad consensus to perform these biopsies three months~     and one year after the transplantation. Performing screening biopsies has led to the~     identification of subclinical forms of rejection, i.e. graft infiltration by recipient~     immune effectors meeting the Banff histological criteria, but without increase in~     creatininemia.~      Assuming that about 10% of screening biopsies performed at 3 months reveal a subclinical~     rejection, which needs to be treated, the management strategy for the remaining 90% of~     patients, whose biopsies show either i) a mild inflammatory infiltrates: i.e. borderline~     changes, or ii) the complete absence of immune effectors in the graft is, poorly~     standardized.~      The investigators therefore propose to conduct a prospective randomized trial to answer these~     questions simultaneously by evaluating a strategy to optimize the immunosuppression of renal~     graft recipients based on the presence or absence of subclinical intragraft inflammatory~     infiltrates in the screening biopsy performed at 3 months post transplantation. Patients with~     borderline changes (sub-study A) will be randomized to receive a treatment for rejection~     (corticosteroid boluses). Patients without inflammation in their graft (sub-study B) will be~     randomized for corticosteroid withdrawal. Impact on graft function, progression of~     histological lesions and incidence of morbidity will be evaluated.~   "
85767|NCT02444416|"~     Context:~      Heart failure is associated with a high morbidity and mortality rate and represents a~     significant worldwide public health burden. In European countries, the total amount of the~     expenses related to heart failure represents 1 to 2% of the total health budget with 75%~     spent during hospitalizations, making heart failure the most expensive pathology in~     cardiology. Acute heart failure (AHF) has a poor prognosis despite improvements in therapy.~     Hospital mortality is 2 to 4% the risk of death or readmission in the six months following~     hospitalization is high.~      Patients hospitalized for heart failure represent a very heterogeneous population in terms of~     etiologies, clinical presentations and/or co-morbidities. Consequently, this implies variable~     outcomes in terms of morbidity and mortality, probably due to their different prognostic~     factors. The precise spectrum of etiologies and prognostic factors of AHF in non selected~     populations has not been exhaustively studied and only a few predictive models concerning AHF~     have been validated.~      Ischemic heart disease, valvulopathy, arrhythmias, infections, hypertension and lack of~     therapeutic compliance are often quoted as being the factors triggering heart failure. Some~     triggering factors (ischemic heart disease, pulmonary infections, acute renal failure) seem~     to be strongly associated with a poor prognosis in terms of hospital/out-patient mortality~     and re-hospitalization rate.~      The complex relation between heart failure and acute renal failure is defined by the~     cardio-renal syndrome. Thirty percent of patients hospitalized for AHF will be diagnosed with~     an acute renal failure at admission or with worsening kidney failure during hospitalization.~     It seems that heart failure and cardio-renal syndrome are two distinct entities with a~     different prognosis. The type of acute renal failure (functional, renal or post-renal) in~     these patients and the prognostic value of these etiologies is still not firmly established.~      A thorough determination of the etiologies and prognostic factors of AHF are necessary in~     order to allow the identification of high-risk patients and the improvement of heart failure~     management.~      Objectives:~        -  To create an observational registry of all patients hospitalized for a AHF~        -  To determine the precise prevalence of etiologies and the prognostic factors of AHF in a~          non selected population. Among the prognostic factors, to establish the specific role of~          acute renal failure~        -  To establish the optimal initial assessment of patients hospitalized for heart failure~        -  To validate and compare with prospective data the results of a retrospective cohort~          study carried out at the University Hospital of Geneva who established the~          re-hospitalization and mortality outcome of patients hospitalized for heart failure.~      Method:~      Creation of an observational registry associated with a biobank including patients~     hospitalized for AHF in the Department of General Internal medicine (SMIG) and in the~     Departments of Specialties at the University Hospital of Geneva.~      Anticipated results:~        -  To identify the prevalence of the etiologies and the prognostic factors of the heart~          failure~        -  To establish the optimal initial assessment of the patients hospitalized for a heart~          failure. Among the prognostic factors, to establish the specific role of acute renal~          failure~        -  To validate and compare results of a retrospective cohort study carried out at the~          University Hospital of Geneva which established the re-hospitalization and mortality~          outcome of patients hospitalized AHF~        -  To improve the management of hospitalized patients with AHF with a robust identification~          of the etiologies and a better identification of high-risk patients.~   "
85768|NCT02444403|"~     Background: Policing practices are key drivers of HIV among people who inject drugs (PWID).~     This study prospectively examines the impact of a police education program (PEP) to align law~     enforcement and HIV prevention. PEPs incorporating HIV prevention, (including harm reduction~     programs like syringe exchange) have been successfully piloted in several countries but were~     limited to brief pre-post assessments; the impact of PEPs on policing behaviors and~     occupational safety is unknown. Objectives: Proyecto ESCUDO (Project SHIELD) aims to evaluate~     the efficacy of the PEP on uptake of occupational safety procedures, as assessed through the~     incidence of needle stick injuries (NSIs) (primary outcome) and changes in knowledge of~     transmission, prevention and treatment of HIV and viral hepatitis; attitudes towards PWID,~     adverse behaviors that interfere with HIV prevention, and protective behaviors (secondary~     outcomes). The investigators hypothesize that, over the course of the 24-month follow-up, the~     PEP will be associated with significant declines in NSI incidence, improved knowledge of HIV~     and related infections, uptake of occupational safety measures, and decreases in behaviors~     that undermine HIV prevention (e.g. syringe confiscation, police harassment of PWID at opioid~     substitution therapy and syringe exchange programs). Methods/Design: ESCUDO is a Hybrid Type~     2 design that simultaneously tests an intervention and an implementation strategy. Using a~     modified stepped-wedge design involving all active duty street-level police officers in~     Tijuana (N= ~1200), the investigators will administer one 3-hour PEP course to groups of~     20-50 officers until the entire force is trained. NSI incidence and geo-coded arrest data~     will be assessed from department-wide de-identified data. Of consenting police officers, a~     sub-cohort (N=500) will be randomly sampled from each class to undergo pre- and post-PEP~     surveys with semi-annual follow-up for 2 years to assess self-reported NSIs, attitudes and~     behavior changes. Impact on PWIDs will be externally validated through a parallel cohort of~     Tijuana PWIDs. Discussion: This is the first trial to assess efficacy of a PEP on policing~     behaviors that place PWID and police at elevated risk of HIV and blood-borne infections.~     Findings may help bring PEPs to scale in the growing number of countries where policing is a~     documented driver of HIV acquisition.~   "
85769|NCT02444390|"~     This is a prospective biomarker study to show that p4EBP1 staining predicts clinical benefit~     from treatment with everolimus in patients who are eligible for everolimus+exemestane~     treatment. This trial is not aimed at evaluating a drug activity. Everolimus and exemestane~     are prescribed within their approved indication as per usual practice and are not part of~     this trial.~   "
85784|NCT02444195|"~     The purpose of this study is to evaluate the effectiveness of self-administered perioperative~     guided imagery to reduce perioperative distress in gynecologic oncology patients undergoing~     surgical management for a presumed cancer diagnosis.~   "
85770|NCT02444377|"~     Purpose: The purpose of this study would be to evaluate the effects of interval training on~     cardiovascular health, lipid profile and body composition in overweight and obese men and~     women.~      A secondary purpose will be to compare lab based measurements of body composition~     [4-compartment model (4C)) with portable equipment [bioelectrical impedance spectroscopy~     (BIS) and ultrasound (US)]~      Participants: Seventy-six men and women (age 18-55 yrs; BMI 25-45 kg/m2) will be randomly~     assigned to a high-intensity short interval group (SIT), high-intensity long interval group~     (HIT) or a control group (CON). Procedures (methods): Participants will be assessed for peak~     oxygen utilization (VO2peak), blood lipids, glucose and insulin levels. Body composition will~     also be measured using a 4C model, as measured from dual energy x-ray absorptiometry (DEXA),~     air displacement plethysmography (BodPod), and BIS, in comparison to US values. Participants~     assigned to either training group will undergo 3 weeks of interval training, 3 days per week.~     SIT will complete 10 bouts of a series of 1 min cycling with 1 min rest periods at 90% of the~     power output obtained during VO2peak;in comparison HIT will complete 5 bouts of the same~     protocol: 2 min bouts with 1 min recovery at varying intensities of VO2peak (80-100% power~     output).~   "
85771|NCT02444364|"~     Participants will be persons with Type 2 Diabetes who are likely to have increased risk of~     bone fractures. The investigators believe this medication will enhance bone turnover.~      The investigators will use DXA measurements to evaluate bone density before and after~     subjects take the medication.~   "
85772|NCT02444351|"~     Nocturnal calf cramps is a common complaint in patients with lumbar spinal stenosis. The~     purpose of this study is to evaluate the effect of botulinum toxin A injection into the~     gastrocnemius muscle in lumbar spinal stenosis patients receiving conservative therapy. We~     will compare pain score, insomnia severity, functional ability, patient satisfaction, and~     neurophysiological variables change using electrical stimulator between control (conservative~     management for spinal stenosis) and botox group (conservative management for spinal stenosis~     plus botox injection into the gastrocnemius muscle).~   "
85773|NCT02444338|"~     To study the safety and effectiveness of the MitraClip System in the treatment of clinically~     significant functional mitral regurgitation in patients with New York Heart Association~     (NYHA) Functional Class II to Class IV chronic heart failure.~   "
85774|NCT02444325|"~     The investigators primary objective is to conduct a pilot randomized trial to determine the~     effect of group prenatal care on self-care activities in women with diabetes.~   "
85775|NCT02444312|"~     A randomised controlled trial that will compare the effects of a brief benefit -finding~     writing intervention with an active control condition on quality of life and psychological~     health among informal caregivers.~   "
85776|NCT02444299|"~     Aequalis® Resurfacing Head implant is a range of shoulder arthroplasty device available for~     the treatment of various shoulder pathologies. It received CE Mark in June 2007.~      The aim of this study is to collect immediate medium and long term data on performance and~     safety of the implant, retrospectively as well as prospectively, from a consecutive series of~     patients to assess the patients' outcomes and functional status.~   "
85777|NCT02444286|"~     To evaluate the safety and efficiency of the MitraClip system in the treatment of patients~     with clinically significant mitral regurgitation with New York Heart Association (NYHA)~     Functional Class II to IV chronic heart failure.~   "
85778|NCT02444273|"~     The primary outcome of this study is to demonstrate the feasibility of a prehabilitation~     program at Barnes Jewish Hospital for liver transplant candidates. Those patients who consent~     to participate in the study and are placed on the transplant list will be randomized into~     either the control or intervention group. The intervention group receives a personalized home~     exercise program along with weekly phone calls to provide coaching, mentoring and motivation.~     Data collected at baseline, post-transplant and, post-transplant follow up will be compared~     among the two study groups. The secondary outcomes include: normative data of functional~     measures for patients with end stage liver disease and to determine the effect size for~     future research on prehabilitation in the patient population.~   "
85779|NCT02444260|"~     The aim of this RCT is to compare patient outcomes of inguinal hernioplasty under Local~     Anaesthesia alone versus Local Anaesthesia and Conscious Sedation~      Specific study objectives are to determine the effect of conscious sedation on:~      (i) patient satisfaction (ii) postoperative pain (iii) time to discharge (iv) intraoperative~     complications (v) postoperative functional status (vi) short-term postoperative complications~     (vii) long-term postoperative complications~   "
85780|NCT02444247|"~     The purpose of this study is to understand how to make exercise more attractive to people.~   "
85781|NCT02444234|"~     The proposed study is designed to characterize the pharmacokinetics of intravenous and oral~     tedizolid in patients with Cystic Fibrosis.~   "
85782|NCT02444221|"~     To discover outcomes of patients treated with Rivaroxaban with atrial fibrillation with at~     least one additional investigator-determined risk factor for stroke in real-life practice.~   "
85783|NCT02444208|"~     Cocaine abuse is an unrelenting public-health concern. Behavioral therapies are considered~     the standard of care for reducing cocaine use and preventing relapse. However, even with~     intense behavioral interventions, rates of relapse to cocaine use are discouragingly high~     (i.e., 60-95% of patients return to drug use). Novel strategies are urgently needed to~     improve treatment outcomes for cocaine-use disorders. The overarching goal of this project is~     to assess the feasibility, acceptability and initial efficacy of an innovative cocaine-based~     inhibitory-control training procedure. This goal will be accomplished through the conduct of~     a Stage I pilot trial. Cocaine-dependent participants will be enrolled and randomized to~     receive inhibitory-control training to cocaine or neutral images (N=20/condition). This~     proposed intervention, cocaine based inhibitory-control training, will be delivered using an~     innovative computer program which teaches cocaine abusers to inhibit a pre-potent response to~     cocaine or neutral cues. The primary hypothesis is the proposed procedures are feasible and~     acceptable to the participants. Feasibility will be assessed by determining time needed to~     enroll the target sample; adaptive randomization outcomes; participant attendance, completion~     and adherence to study procedures. Acceptability will be determined using a Treatment~     Acceptability Questionnaire. The secondary hypothesis is that participants receiving~     cocaine-based inhibitory-control training will reduce their drug use to a greater extent than~     their counterparts in the neutral-image condition. Reduced cocaine use will be demonstrated~     by fewer positive-urine samples using qualitative urinalysis and a reduction in levels of~     benzoylecgonine as determined by quantitative urinalysis (i.e., ELISA). The third hypothesis~     is that participants receiving cocaine-based inhibitory-control training will show improved~     inhibitory control and neurocognitive functioning relative to their counterparts in the~     neutral-image condition. Improved inhibitory control, impulsivity and cognitive functioning~     will be demonstrated using a battery of clinical instruments and laboratory tasks. The~     proposed research is highly innovative in that it will provide critical information regarding~     the feasibility, acceptability, initial efficacy of cocaine-based inhibitory-control training~     to reduce drug use and improve inhibitory control and neurocognitive functioning in~     cocaine-dependent participants. Cocaine-based inhibitory control training is also easy to~     administer (i.e., 15 minutes), inexpensive, need not be administered by a clinician, and~     could easily be incorporated into current behavioral or community-based treatment approaches~     to enhance sustained abstinence, thereby quickly impacting clinical research and practice.~   "
85785|NCT02444182|"~     Some probiotics have been shown to have preventive effects on infectious diseases and~     allergies. Because their long-term enhancement of the immune responses of children, they have~     been recommended for infants in some countries. The most promising ones seem to be the~     combination of Bifidobacterium lactis BB-12 and Lactobacillus rhamnosus GG. Probiotic~     microbes are mainly ingested orally and the gastrointestinal tract is thus the primary target~     organ for them. However, the mouth is the first part of the gastrointestinal tract. Most~     probiotics are in theory cariogenic, thus their effects on oral health should be known.~     Several probiotics decrease levels of salivary mutans streptococci (MS), but in other~     respects very little is known about their effects on the oral microbiota. Also effects of~     probiotics on dental plaque should be studied. This study aims to find out the effects of the~     combination of BB-12 and LGG, delivered with a lozenge (4 weeks, twice a day) with a mixture~     of them on the amount of plaque and gingival health~   "
85786|NCT02444169|"~     A retrospective study to evaluate the Ulthera® System for its potential interaction with~     toxins and fillers. Up to 500 subjects will be enrolled.~   "
85787|NCT02444156|"~     Primary research question: What is the effect of indoor rowing, under the ideal circumstances~     of a laboratory setting, on glucose control in adults with impaired glucose control?~      Secondary research question: Is it possible to develop a full-scale study of the benefits of~     indoor rowing under the usual circumstances of a community setting?~      Why? It is good practice to conduct a small pilot study before embarking on an expensive~     full-scale study.~      What? Around 150 minutes of aerobic exercise and around 150 minutes of resistance exercise~     per week are necessary to meet prevailing recommendations for adults with impaired glucose~     control. Around 120 minutes of indoor rowing per week might be a less time-consuming~     alternative to prevailing recommendations because indoor rowing involves a combination of~     aerobic and resistance exercise.~      Who? Twenty men and postmenopausal women aged 45-65 years with impaired glucose regulation,~     such as those with type 2 diabetes. Eligible volunteers will not have smoked in the last~     year, will not have exercised regularly in the last six months, and will not be taking any~     form of diabetes medication other than metformin. Eligible volunteers will have stable weight~     and a body mass index of 25-40.~      Where and how? Before and after the exercise intervention, glucose control (postprandial~     blood glucose concentrations) will be assessed at Leicester Diabetes Centre and cardiac~     function (MRI) will be assessed at Glenfield Hospital. During the exercise intervention,~     participants will use an indoor rower three times per week for 12 weeks at Leicester Diabetes~     Centre. Participants will be taught how to row correctly and the duration and intensity will~     gradually increase. In order to inform the design of a full-scale trial, recruitment rate~     will be assessed, adherence will be monitored, and a third party will interview participants~     to find out if the intervention and assessments are feasible and acceptable.~   "
85788|NCT02444143|"~     Tacrolimus extended release (Astagraf) has recently been approved by the FDA as a once a day~     dosing regimen. This formulation has the potential to improve compliance. Current dosing~     recommendation for the extended release formulation in renal transplant is 0.15 mg/kg/day~     administered once daily in the morning. There are no specifications on appropriate dosing in~     obese patients or on whether to use actual, ideal or and adjusted weight. It will be~     advantageous to understand the pharmacokinetics of this medication in the obese to determine~     the appropriate dosing regimen. In this study, obese patients will be randomized to receive~     tacrolimus extended release 0.15 mg/kg/day based on either ideal body weight (IBW) or~     adjusted body weight (aBW).~   "
85789|NCT02444130|"~     The main purpose of this study was to identify electrophysiological predictive markers of~     post-correction visual comfort for presbyopic patients.~   "
85790|NCT02444117|"~     This study aims to identify clinical and biological markers which would allow to evaluate~     precisely the evolution of children with autism spectrum disorders throughout intervention.~   "
85791|NCT02444104|"~     To evaluate and to validate accuracy, precision and trending ability of blood pressure and~     cardiac output measurement by applanation tonometry in cardiological patients having:~        -  atrial fibrillation~        -  severe impaired leftventricular function~        -  severe aortic valve stenosis~        -  patients having left ventricular assist device~      Experimental measurement: continuous blood pressure measurement and cardiac output~     measurement is performed by the T-Line 200 pro device (Tensys Medical Inc., San Diego, USA)~     Control measurement: gold-standard continuous blood pressure measurement is performed by~     invasive blood pressure measurement by arterial cannulation and cardiac output reference is~     assessed by transcardiopulmonary thermodilution~   "
85792|NCT02444091|"~     Significant clinical improvements of ME/CFS symptoms were observed in two patients with~     long-standing ME/CFS who received adjuvant chemotherapy including cyclophosphamide for breast~     cancer, also in one ME/CFS patient who received chemotherapy including iphosphamide for~     Hodgkin lymphoma.~      Three pilot ME/CFS patients were thereafter treated with six intravenous infusions four weeks~     apart, in two of these with a significant clinical response.~      The hypothesis is that a subset of ME/CFS patients have an activated immune system, and that~     ME/CFS symptoms may be alleviated by treatment with cyclophosphamide as intravenous pulse~     infusions four weeks apart, six infusions in total.~      The purpose of the present study is to treat ME/CFS patients with cyclophosphamide as~     intravenous pulse infusions four weeks apart, six infusions in total. The effects on ME/CFS~     symptoms and tolerability/side effects during 12 months follow-up will be registered, and~     additional tests will be performed to objectively register changes in physical ability during~     follow-up. Studies to investigate possible large vessel endothelial dysfunction and skin~     microvascular dysfunction will be performed before start of intervention and during~     follow-up.~   "
85793|NCT02444078|"~     This is a cluster randomised controlled trial composed of two research arms: exercise~     training group (experimental group) and a social activity group (control group).~   "
85794|NCT02444065|"~     Treatments for bulimia nervosa (BN) have relatively high rates of nonremission and relapse,~     meaning that improving treatments is a high priority in this area. Rapid response to~     treatment -cessation of binge eating and vomiting symptoms within the first weeks of~     treatment - is a robust predictor of improved post-treatment outcomes and lower relapse~     rates, but no study has tried to facilitate rapid response as a means of improving treatment~     outcomes. The present study responds to this gap in the literature by testing a 4-session~     CBT-based individual intervention for rapid response (i.e., CBT-RR), designed to augment~     standard day hospital (DH) treatment for BN and Purging Disorder (PD) by focusing on~     strategies and skills for rapid symptom interruption. CBT-RR will be compared to a~     matched-intensity augmentative motivational interviewing (MI) intervention. Participants will~     be recruited from a hospital-based day program for eating disorders, and will be randomly~     assigned to one of the two conditions in addition to the DH as usual. participants will be~     assessed at pre-intervention, post-intervention, week 4 of DH, post-DH, and 6 months~     follow-up. It is hypothesized that compared to those who receive MI, patients who receive~     CBT-RR will be more likely to exhibit a rapid response to day hospital treatment (i.e., </= 3~     binge eating and/or vomiting episodes in the first 4 weeks). It is further hypothesized that~     patients who receive CBT-RR will exhibit fewer binge eating and/or vomiting episodes at~     post-DH and at 6-month follow-up. Potential mediators and moderators of these hypothesized~     treatment effects will be examined on an exploratory basis, including self-efficacy,~     motivation, and hope (potential mediators), and emotion regulation, depression, cognitive~     psychopathology of eating disorders, and working alliance with the therapist (potential~     moderators).~   "
85795|NCT02444052|"~     The purpose of this study is to evaluate clinically, histologically and radiographically the~     healing of extraction sockets with Zimmer's Puros® allograft compared to creos™ (creo™ Nobel~     Biocare,), a low-cost allograft material, 90 days following exodontia.~   "
85797|NCT02444026|"~     The aim is, in a randomized controlled trial, to test the feasibility and evaluate the~     efficacy of an internet-based treatment for insomnia, previously tested in a group of 28 US~     cancer patients, in a large sample of Danish breast cancer survivors who are experiencing~     significant sleep problems 0-3 years after treatment. The investigators aim to test the~     following hypotheses: That a group receiving Internet-delivered cognitive-behavioral therapy~     (CCBT) for insomnia (CCBT-I) will experience reduced sleep latency, more hours of sleep,~     fewer awakenings during the night, improved sleep efficiency, increased subjective sleep~     quality, and improved quality of life after the intervention, when compared to a waiting list~     control group. The investigators also aim to explore a number of possible moderators of the~     effect (comorbidity, depression, fear of cancer recurrence tendency to ruminate) and~     mediating mechanisms (changes in sleep habits and sleep-related lifestyle factors).~   "
85798|NCT02444013|"~     The purpose of this study is to determine whether periprocedural administration of folic acid~     is effective in the prevention of contrast induced nephropathy in patients undergoing~     coronary CTA/angiography/angioplasty.~   "
85799|NCT02444000|"~     Patients with 1p/19q-codeleted anaplastic gliomas treated with RT + PCV are at risk of~     neurocognitive deterioration. Treating these patients with PCV alone (could reduce the risk~     of neurocognitive deterioration without impairing overall survival.~   "
85800|NCT02443987|"~     The primary aim of this study is to compare, in women undergoing tension-free vaginal tape~     (TVT) insertion under sedation and local anaesthetic infiltration, the time interval of first~     void following surgery between a group of patients who received intravenous fluids to those~     who did not.~   "
85801|NCT02443974|"~     Background: Osteoarthritis (OA) is highly prevalent in the elderly, with the knee being the~     most commonly affected joint in this population. Knee braces are often used to prevent common~     problems in knees during daily activities. The purpose of these devices is to decrease pain~     and improve functionality. In the literature some studies have tested the effectiveness of~     unloader brace for valgus or varus. However, the braces most used in the investigators'~     clinical setting and the less costly ones have not been described in quality studies in the~     literature. There are only few studies on this subject and they are methodologically~     inadequate. There are no studies that compared the effectiveness between the knee brace with~     metal hinges (no alignment) and knee brace without metal hinges. Objective: To evaluate the~     effectiveness of knee braces on pain, function and quality of life in the elderly with knee~     OA. Methods: Elderly with knee OA, both genders, with pain scale 3-7cm on a 10cm pain numeric~     scale were included. Of the 222 patients screened, 120 met the eligibility criteria and were~     randomized to the groups: without metal hinges, with metal hinges or control group. The~     groups without and with metal hinges received knee brace and were instructed to use it in~     daily activities, every day, during three months. Assessment for pain (NPS), function (WOMAC~     and Knee Lequesne) and quality of life (SF-36) were done at baseline and after 45, 90 and 180~     days by a blinded assessor.~   "
85802|NCT02443961|"~     Bronchopulmonary Dysplasia (BPD) is the most frequent disease related to a premature birth,~     15-50% of very low birth newborns (<1500 gr.) will develop BPD. The prevalence of BPD is~     increasing due to the advances in neonatology, with a rise in the survival of smaller and~     more premature babies. The etiology of BPD is multifactorial, in which oxygen, maternal~     chorioamnionitis, insufficient pulmonary maturation etc. have an important role. These~     factors lead to a pathological development of the lung and pulmonary vessels, developing~     secondary Pulmonary Hypertension (PH). Nowadays there is no efficient treatment; this~     generates a important sanitary burden and a decrease in life quality. Multiple experimental~     models in mice have studied Mesenchymal Stem Cell (MSC) therapy as prevention of BPD, also~     recently some clinical trials have tried this therapy on premature newborns with promising~     results. Hypothesis: MSC therapy in patients at high risk of BPD prevents pulmonary lesions.~     Methods: The investigators have designed a clinical trial to evaluate the feasibility and~     security of MSC therapy in patients at high risk of developing BPD.~   "
85803|NCT02443948|"~     This observational study is proposed to evaluate if the trend in the levels of cf-DNA~     evaluated on a sample of peripheral blood may be related to different clinical behaviors of~     the disease monitored by radiological investigations conducted.~   "
85804|NCT02443935|"~     Combination antiretroviral treatment (cART) effectively suppresses virus replication and~     partially restores immune functions. However, cART cannot cure HIV infection.~      This study aim to investigate whether the antiviral immune response can be enhanced and/or~     viral transcription reactivated with MGN1703. MGN1703 is an agonist to toll-like receptor~     (TLR) 9. Activation of TLR9 has been shown to augment innate and adaptive immune effector~     functions, most notably enhanced NK cell and T cell functions.~      Furthermore, TLR9 agonists have been shown in vitro to reactivate viral transcription in~     latently infected cells, potentially leading to enhanced recognition of infected cells by the~     immune effector cells.~   "
85805|NCT02443922|"~     A multi-year clinical study to improve tools for measuring the function of insulin-producing~     beta cells in people with type 2 diabetes mellitus.~   "
85806|NCT02443909|"~     To compare safety and efficiency of 20w 30w holmium laser device in treatment of 2-3 cm~     diameter kidney stones with Retrograde Intrarenal Surgery (RIRS).~   "
85807|NCT02443896|"~     The purpose of thus study is to assess the feasibility and inform the planning of a proposed~     definitive randomised controlled clinical trial to investigate the efficacy of sealing~     permanent molars in children requiring caries related extractions under a chair General~     Anaesthetic.~   "
85808|NCT02443883|"~     The main purpose of this study is to evaluate the safety and feasibility of administering~     higher doses of ramucirumab in participants with gastric cancer.~   "
85809|NCT02443870|"~     The long-term changes of bladder function in individuals with lower urinary tract dysfunction~     will be investigated. Patients presenting for regular urodynamic examination of bladder~     function will be included. Bladder diary details and urodynamic data will be collected in~     order to investigate bladder function.~   "
85810|NCT02443857|"~     The purpose of this study is to investigate the applicability and feasibility of the newly~     developed robot platform for upper extremity therapy (ChARMin) in children undergoing~     neurorehabilitation.~   "
85811|NCT02443844|"~     The purpose of this study is to compare medical and surgical treatments of benign prostate~     hyperplasia in patients who have non muscle invasive bladder cancer for tumour recurrence and~     progression.~   "
85813|NCT02443818|"~     It was found that people who have an excessive growth in one or more parts of their body and~     normal growth in other parts, may have a change in genes responsible for controlling cell~     growth. This genetic discovery identified a possible treatment for this overgrowth, called~     Sirolimus.~      This is a pilot study, which help the investigators prepare a larger international study,~     which will aim to determine whether a treatment based Sirolimus is able to stop the excessive~     growth of one or more parties of their body in people who carry a genetic change in the~     PIK3CA gene (phosphatidylinosilol-3-kinase encoded by the gene PIK3CA).~   "
85814|NCT02443805|"~     The objective of this study is to assess the efficacy and safety of 12 months of treatment~     with 300 IR of STG320 sublingual tablets compared with placebo in adults and adolescents with~     HDM-associated allergic rhinitis.~   "
85815|NCT02443792|"~     RCT of Unicirc under topical anesthetic w/ cyanoacrylate wound sealing vs. open surgical~     circumcision under local anesthetic with suturing.~   "
85816|NCT02443779|"~     The purpose of this study is to examine if a correlation exists between findings from brain~     imaging studies of the status of the dopamine system in the brain using DaTscan and SPECT~     imaging, clinical symptoms of Parkinson's disease, and changes in the structure of the retina~     as detected by optical coherence tomography (OCT) in recently diagnosed and more advanced~     Parkinson's disease patients.~   "
85817|NCT02443766|"~     Over 2 decades scientists have been studying the effect on brain function from meditation~     practices. The purpose of this study is to measure the effect of a meditation retreat program~     on serotonin and dopamine transporter binding and changes in cerebral blood flow. The retreat~     program that will be followed is a week-long retreat called the Ignatian Retreat.~   "
85818|NCT02443753|"~     This study will evaluate the safety and efficacy of the EndoBarrier® SANS™ in overweight and~     obese subjects with type 2 diabetes. The barbless second generation device is being developed~     as a means to reduce the incidence of adverse events associated with the barbs of the~     predicate device while maintaining a similar efficacy profile as measured by changes in~     weight and diabetic endpoints (HbA1c, blood glucose, insulin, etc.). This first use in human~     will primarily evaluate preliminary safety, tolerability and efficacy of the new design.~     Because of the new design and its first study in human subjects, only a 3 month implant~     duration will be evaluated in this study.~   "
85819|NCT02443740|"~     This is a First in human (FIH) single ascending dose study to evaluate the safety,~     tolerability and pharmacokinetics (PKs) of PF-05251749 following single oral doses in healthy~     human subjects~   "
85820|NCT02443727|"~     The main objective of this project is to study whether intranasal oxytocin (OT) affects how~     young adults perceive and attend to infant and adult faces. Based on existing research the~     investigators predict that oxytocin will facilitate the allocation of attentional resources~     on infant faces (compared to adult faces). The investigators also predict that oxytocin will~     enhance the activity of reward neural-networks associated with the perception of infant~     faces. The behavioral effects of OT (visual attention and face recognition) will be measured~     with eye-tracking while participants look at photographs of adult and infant faces.~     Neurological effects (the activity of emotion and reward networks) will be measured with~     functional Magnetic Resonance Imaging (fMRI) while participants look at infant faces on a~     computer screen.~   "
85821|NCT02443714|"~     Needle-free jet injector provides an alternative for patients with diabetes treated by~     insulin. This study aimed at evaluating pharmacokinetics and pharmacodynamics (PK-PD)~     profiles of lispro administered by jet injector and conventional pen.~   "
85822|NCT02443701|"~     Background: Volleyball players constantly perform vertical jumps, the higher the height of~     the jump is better sports performance of these players. Several methods have been tested to~     improve jumping performance in these players. It will be investigated the addition of~     electrical stimulation and phototherapy to jump training in volleyball athletes. DESIGN:~     randomized controlled trial. METHODS: This study will be conducted with 36 male athletes~     volleyball with minimum experience of 12 months sport. Will be randomized and assigned to 3~     groups (control group, NEMES group and group phototherapy). All 36 healthy volleyball~     athletes who passed the initial selection and agreed to participate in the study, conduct a~     muscle strength and jump training program, which is held in both legs simultaneously. The 12~     healthy athletes electrical stimulation group will perform the same training program~     described above, but strength training is associated with electrical stimulation. The 12~     healthy athletes participating in the phototherapy group will undergo a phototherapy protocol~     before performing the strength and jump training. All selected participants will undergo an~     assessment of muscle strength of knee extensors and evaluate the jump. These evaluations were~     baseline, 6 weeks and 8 weeks after baseline.~   "
85823|NCT02443688|"~     This study is a Phase 2, double-blind, randomized, placebo-controlled study to evaluate the~     safety and efficacy of CTX-4430 administered once-daily for 48 weeks for treatment of CF.~   "
85824|NCT02443675|"~     Observational Study of Pain Reduction in Late Stage Cancer Patients Receiving Low-Dose~     Chemotherapy~   "
85825|NCT02443662|"~     Children born with univentricular heart will go through step surgery and end up with a Fontan~     circulation. A circulation with cause problems with body fluid balance.This project will~     evaluate changes in interstitial colloid osmotic pressure in patients 10 year after~     completion of a three step Fontan surgery. This project will evaluate whether increased micro~     vascular leakage and change in interstitial colloid osmotic pressure are present in patients~     after ten years with a Fontan circulation.~   "
85845|NCT02443389|"~     Introduction:~      Based on single-center data, approximately 1 of every 3 newborns admitted to tertiary level~     neonatal intensive care units (NICU) develops acute kidney injury (AKI), and those with AKI~     have significantly worse outcomes. To stimulate discussion among researchers, the NIH NIDDK~     sponsored a workshop on neonatal AKI in April 2013. At that workshop, the group recognized~     the need to improve collaborations between neonatologists and nephrologists within and across~     centers. The investigators have created a multi-institutional, multi-disciplinary group,~     Neonatal Kidney Collaborative (NKC), in order to address the following critical needs~     identified at the workshop: AWAKEN is the inaugural study of this new collaboration.~        1. Development of a standardized evidence-based definition of neonatal AKI~        2. Evaluation of risk factors that predispose neonatal to AKI~        3. Investigation into how fluid provision/ balance impacts biochemical and clinical~          outcomes~   "
85826|NCT02443649|"~     Insomnia is a significant problem affecting 10 to 20% of US population. Long-term~     pharmacological treatments are not recommended due to side effects, with therapy and sleep~     hygiene education often employed as alternatives. Use of mind-body approaches for insomnia is~     increasing. One of the most promising mind-body approaches for alleviating sleep problems is~     hypnosis. Research indicates significant beneficial effects of hypnosis on sleep, but sleep~     was rarely assessed as primary outcome and studied populations were diverse. Further, it~     remains unclear who the best candidates for benefitting from hypnosis are. To address some of~     the gaps in the current knowledge, the study evaluates whether 1) an addition of hypnotic~     suggestion for sleep improvement to the optimizing sleep hygiene (OSH) program increases the~     effectiveness of the OSH using objective and subjective assessments and 2) determines~     characteristics associated with hypnotic responsiveness.To address these goals a randomized~     controlled trial (RCT) with 3 laboratory visits (baseline, intervention, and 1 month~     follow-up) will be conducted with 50 adults meeting criteria for primary insomnia and~     allocated to one the two groups: 1) experimental group receiving during the intervention~     visit a combination of the Optimizing Sleep Hygiene (OSH) program and a hypnosis session for~     sleep improvement and 2) a control group receiving at the intervention visit the OSH only.~     Hypnosis session for sleep improvement for the control group will be offered at the end of~     the follow-up study visit (conducted after 4 weeks post-intervention) after completing all~     follow-up measures. Each study visit will last for 2-3 hours. During the visits sleep,~     personality traits and daily function of the participants will be assessed. Further, after~     the baseline and one week before the follow-up visit subjects will wear a watch-like~     actigraphic device monitoring their sleep patterns at home and will complete sleep diary.~      The knowledge gained from this study will inform the literature and clinicians about~     usefulness of hypnosis for insomnia sufferers and will help identify the population of~     insomnia sufferers most likely benefit from use of hypnosis for sleep~   "
85827|NCT02443636|"~     While effective interventions for depression exist, their success rates are unsatisfactory~     and their provision is haphazard. The Canadian Depression Research and Intervention Network~     (CDRIN) Maritimes Depression Hub will improve the delivery of care and the quality of~     outcomes for youths, adults and seniors with depression across the Maritimes. The~     investigators will establish an integrated system of assessment, treatment, research and~     education related to depression with the active involvement of those with lived experience.~     The establishment of a patient registry is a key step that will facilitate evaluation and~     reform of current services, integration of patient choice and community resources into~     treatment programs, monitoring long-term outcomes, and development of more effective~     treatment approaches through research. The registry will facilitate research that will~     include validation of new diagnostic and outcome measurement tools, low-cost clinical trials~     and collaborative projects with national and international partners. Educational programs~     will involve training the next generation of researchers, those with lived experience,~     clinicians, and health system managers in critical appraisal and will facilitate their~     involvement in research. The registry, the proposed systematic measurement of outcomes and~     the broad dissemination of information and skills will improve the quality of research and of~     care as well as the experience of patients and their families.~      The need for a registry: It is increasingly recognized that major advances in the treatment~     of mental disorders will require large scale clinical research. Recently demonstrated ways of~     completing large-scale research with finite resources include the routine use of electronic~     health records (EHR), data linkage and randomized registry trial. Use of EHR is the most~     efficient way of rapidly obtaining large amounts of information. However, EHR cannot~     completely exclude confounding by indication and other unmeasured variables. Therefore, tests~     of treatment effects require experimental designs that cannot be replaced by routine health~     records data. The gold standard for testing the effects of treatment in an unbiased way is~     the randomized controlled trial (RCT), where measured and unmeasured confounders are balanced~     through the randomization process and any remaining confounding is due to chance alone. RCTs~     are valued as the highest level of evidence, but are costly and take significant time to be~     completed, partly because of the need to screen a large group of individuals to identify~     eligible participants.~      The most efficient unbiased test of interventions, new treatment modalities and novel ways of~     treatment delivery is a method that combines EHR use with the randomized controlled trial~     (RCT) methodology: the randomized registry trial (RRT). The RRT takes advantage of a registry~     of individuals with available information to identify a large number of individuals suitable~     for an RCT. The RRT approach is efficient especially if the same information (e.g. diagnosis~     and treatment history) is used repeatedly for different purposes. The same information can be~     used for clinical purposes, service improvement and multiple research projects. RRT will~     allow obtaining answers about the efficacy of new treatments and management strategies~     significantly faster and at a much lower cost than traditional RCTs. Therefore, the~     investigators propose to establish a registry that has the capacity to conduct RRTs. The~     proposed registry will be integrated with similar efforts across Canada. Jointly, this~     collaborative network of registries will facilitate fast and economical testing of new~     treatments, which is urgently needed to advance the therapeutic options for people with~     depression and related conditions.~   "
85828|NCT02443623|"~     Objectives:~        -  To vaccinate plasma donors with the ACAM2000 smallpox vaccine thereby inducing an immune~          response resulting in high anti-vaccinia antibody titers. The collection of donor plasma~          will be used in the manufacturing of Vaccinia Immune Globulin Intravenous (VIGIV).~        -  To ensure the safety of plasma donors vaccinated with ACAM2000 through the~          implementation of risk factor screening procedures and the collection of~          post-vaccination safety data.~   "
85829|NCT02443610|"~     The aim of this study is to evaluate the frequencey and the determinants of postpartum major~     complications (hemorrhage and thrombosis) up to 3 months after delivery in the maternity~     hospitals of Finistère (Bretagne - France)~   "
85830|NCT02443597|"~     Determine Cutoff BMI at which transabdominal sonography (TAS) is not satisfactory for~     aneuploidy risk assessment.~   "
85831|NCT02443584|"~     This is a randomized, control group design of pharmacogenetic implementation in a mental~     health population of subjects taking anti-depressants and/or anti-psychotics with a new or~     current primary or secondary diagnosis of Major Depressive Disorder (MDD) or Depressive~     Disorder Not Otherwise Specified (DDNOS).~   "
85832|NCT02443571|"~     This retrospective observational multi centered study has been established to collect the~     clinical experience relating to the administration of Fluciclovine 18F employed in both~     investigator initiated studies and named patient/compassionate use programmes in up to 5~     sites.~   "
85833|NCT02443558|"~     CSI:Brainwave is a multidisciplinary neurophysiological project, developed by the Lab of~     Medical Physics, School of Medicine, Aristotle University of Thessaloniki and supported by~     two Neurosurgical Departments. The project officially commenced on April 2014 and the first~     year was awarded the 2013 Mario Boni Research Grant by the Cervical Spine Research~     Society-European Section (CSRS-ES). The website for the project can be accessed at~     http://medphys.med.auth.gr/content/csi-brainwave.~      The investigation's primary objectives include the development, testing and optimization of a~     mountable robotic arm controlled with wireless Brain-Computer Interface, the development and~     validation of a self-paced neuro-rehabilitation protocol for patients with Cervical Spinal~     Cord Injury and the study of cortical activity in acute and chronic spinal cord injury.~   "
85834|NCT02443545|"~     This is a long-term follow-up to an earlier study, LA38-0411. Its purpose is to gather more~     information about the safety and efficacy of deferiprone in patients with sickle cell disease~     or other anemias who suffer from iron overload caused by regular blood transfusions.~   "
85835|NCT02443532|"~     Patients with type 1 diabetes aged 15-65 years without major complications will be randomized~     either to usual care or to a structured group education program, with 6 four-hour weekly~     interactive sessions devoted to diabetes management. The principal endpoint will be the~     variation of HbA1c at 12 months from enrolment. Secondary endpoints will include quality of~     life, treatment satisfaction, fear of hypoglycemia, incidence of hypoglycemia.~   "
85836|NCT02443519|"~     This randomized clinical trial aims to examine the effect of a standardized 8-week course of~     Mindfulness Based Cognitive Therapy for Migraine on migraine-related disability in people~     with migraine.~   "
85837|NCT02443506|"~     This study is to evaluate the safety of AMG 623 in subjects with systemic lupus~     erythematosus. The study consists of a 21 day screening period followed by administration of~     the investigational product and up to 70 day follow up period.~   "
85838|NCT02443493|"~     Up to 90% of the radiotherapy patients will develop a certain degree of skin reaction at the~     treated area, also known as radiodermatitis (RD).~      Currently, there is a wide variety of strategies to manage RD, including creams, gels,~     ointments, wound dressings. However, up to now, there is still no comprehensive,~     evidence-based consensus for the treatment of RD. Low-level laser therapy (LLLT) is a~     promising, non-invasive technique for treating RD. In a recent pilot study conducted in our~     research group, LLLT prevented the aggravation of RD and provided symptomatic relief in~     patients undergoing radiotherapy for breast cancer after breast-sparing surgery. This pilot~     study was the first prospective study investigating the potential of LLLT for RD. In the~     current study, we want to investigate the efficacy of LLLT as a tool for the prevention of~     radiodermatitis in breast cancer patients.~   "
85839|NCT02443480|"~     The investigators created the St. Paul's Endoscopy Comfort Score (SPECS) which includes the~     frequency of verbal cues, body positioning and anxiety levels with descriptions for each of~     the variables. Our objective is to compare the SPECS, NAPCOMs, NPAT and GS amongst different~     observers and to determine any correlation with patient satisfaction.~   "
85840|NCT02443467|"~     This was an open-labeled, multi-center, prospective, non-comparative study of the safety of~     Herceptin (trastuzumab) used as an adjuvant therapy in patients with early breast cancer who~     had previously received antracycline therapy before or after surgery.~   "
85841|NCT02443454|"~     Central blood pressure and pulse wave velocity were measured using a Complior Analyse device~     in Short and Long-term after kidney transplantation.~   "
85842|NCT02443428|"~     The purpose of this prospective observational registry is to monitor safety of eribulin in~     routine clinical practice. Additionally, this study will also assess the effectiveness of~     eribulin in real-life settings.~   "
85847|NCT02443363|"~     The study included 300 patients who are post-kidney transplantation (> 3 months and <10~     years). An analysis of body composition using bioelectrical impedance, calculated BMI and~     serum creatinine was determined. Glomerular filtration rate (GFR) was calculated using the~     formula CKD-EPI, Modification of Diet in Renal Disease (MDRD) and Cockroft-Gault.~   "
85848|NCT02443350|"~     Anti N-methyl-D-aspartate receptor encephalitis is an autoimmune encephalitis，found in recent~     years，producing the specific IgG antibody induced by the NMDA receptors.It is the most common~     curable disease among the non infectious-autoimmune encephalitis,usually has been~     misdiagnosed as other causes of encephalitis.Our previous study found that there are~     differences between the Chinese and the foreign in anti-NMDA receptor encephalitis such as~     the sex ratio, the rate of combined tumor and clinical manifestations.As a new found~     disease,the incidence rate has been underestimated.Therefore,to establish the Registry~     Research Database for Chinese group of anti-NMDA receptor encephalitis is imminent.This study~     will combine Beijing area's hospitals and foreign experts,depending on multicenter,~     prospective and registry method,to understand the incidence in Beijing area,to summarize and~     analyze the clinical data of patients.So,there will make a solid foundation for the~     subsequent Beijing area detection platform and other research.~   "
85849|NCT02443337|"~     The main purpose of this study is to evaluate the safety and activity of the study drug known~     as LY3023414 in combination with necitumumab in participants with metastatic squamous~     non-small cell lung cancer (NSCLC).~   "
85850|NCT02443324|"~     The main purpose of this study is to evaluate the safety and preliminary efficacy of the~     combination of the study drug known as ramucirumab plus pembrolizumab in participants with~     locally advanced and unresectable or metastatic gastric or gastroesophageal junction (GEJ)~     adenocarcinoma, non-small cell lung cancer (NSCLC), transitional cell carcinoma of the~     urothelium, or biliary tract cancer (BTC).~   "
85851|NCT02443311|"~     Oral lichen planus (OLP) is a chronic disease characterized by periods of remission and~     relapse. Therapeutic objectives for OLP should be to quickly reduce disease symptoms by~     targeting pathophysiological pathways, and to provide long-term management by reducing~     recurrences. Pimecrolimus is a novel topical selective inflammatory cytokine release~     inhibitor; considering its mechanism of action it is reasonable to theorize that pimecrolimus~     may effectively treat OLP without the potential side effects that are associated with~     corticosteroids.~   "
85852|NCT02443298|"~     The objectives of this trial are primarily to evaluate the efficacy and safety of BI~     655066/ABBV-066 (risankizumab) as compared to placebo over a 24-week treatment period in~     severe asthma patients. The primary endpoint is time to first asthma worsening during the~     planned 24 week treatment period for active vs. placebo treated patients on top of standard~     of care therapy. Upon demonstration of a meaningful clinical response, another important~     objective is the identification of biomarkers that can be used to target patients who will~     likely respond to treatment with BI 655066/ABBV-066 (risankizumab).~   "
85853|NCT02443285|"~     Current European and most other international guidelines recommend the use of a~     third-generation cephalosporin as the first choice, or amoxicillin-clavulanate acid or~     fluoroquinolones as an alternative choice .~      These recommendations are based mainly on clinical trials that were very often conducted a~     decade or more ago, and on the assumption that E. coli would be involved in nearly half of~     the cases.~      The microbial etiology of SBP remains relatively constant; however, the antibiotic resistance~     rate especially for third-generation cephalosporins (including cefotaxime and ceftazidime),~     ciprofloxacin, and ofloxacin increased dramatically .~   "
85854|NCT02443272|"~     The purpose of this study is to compare abscess drainage utilizing the vessel loop technique~     in children to the standard incision and drainage technique with the endpoint to determine if~     rates of treatment failure are non-inferior.~   "
85855|NCT02443259|"~     Hypertensive disorders are the most common medical complications in pregnancy and major~     causes of maternal, fetal, and neonatal morbidity and mortality. Fifty percent of~     hypertensive disorders of pregnancy are defined as pre eclampsia, the most important~     manifestation of the disease.~      Preeclampsia is also a significant risk factor in the development of IUGR and represents the~     most common cause of IUGR in the nonanomalous infant. The incidence of thrombocytopenia,~     neutropenia and Bronchopulmonary dysplasia is also increased in neonates with preeclampsia.~      The neurodevelopmental outcomes infants exposed to preeclampsia are highly variable. The~     study by Gray et al showed that preeclampsia is associated with a decreased risk of cerebral~     palsy. They also found a protective effect of maternal preeclampsia on cerebral palsy~     regardless of exposure to magnesium sulfate. However, contrary to this, study conducted by~     Shao-Wen Cheng et al has showed that infants born to pre-eclamptic mothers had lower MDI~     scores at 24 months of age (P= 0.04) as compared to infants without maternal pre-eclampsia.~     The study by Szymonowicz et al showed that neonates born to pre-eclamptic mothers had a~     significantly lower mean mental developmental index, and significantly more of these children~     had one or more impairments compared with the control group at 2 years of age. The~     neurodevelopmental outcomes in neonates born to preeclamptic mothers therefore remain~     inconclusive. Recently the role of neurobehaviour being evaluated early at 37-40 weeks of CGA~     is being predicted as an useful adjunct to the 12-18 month full neurodevelopmental~     assessment. This assumes significance in the context of initiation of early stimulation and~     objectivised individual developmental rehabilitation regimens for these infants.~   "
85856|NCT02443246|"~     To compare the efficacy of Vitamin D3 B.O.N. Intramuscular Injection within 12 weeks with~     that of placebo in adults with Vitamin D Deficiency.~   "
85857|NCT02443233|"~     Globally, hepatitis B virus (HBV) infection is the most common form of chronic hepatitis.~     There are still a lot of uncertainties on how infants acquired HBV leading to the development~     of chronic HBV infection despite active and passive immunoprophylaxis. The investigators~     would like to carry out a prospective study to answer the following questions:~        1. the paternal, maternal and obstetric factors leading to immunoprophylaxis failure~        2. the prevalence of immunoprophylaxis failure in Hong Kong~   "
85884|NCT02442882|"~     Prior research has investigated the effect of repetitive head trauma as it relates to~     physiological and psychological function. Boxing is one particular sport which predisposes~     athletes to a large amount of head impacts. We plan to assess the effects of a boxing~     tournament on balance, neuropsychological, and visual functions.~   "
85858|NCT02443220|"~     A prospective, multiple-center, double-blinded, randomized, controlled clinical study to~     evaluate the antalgic effects between distal-proximal acupoints combination and regional~     acupoints combination stimulated with electroacupuncture on patients undergoing Off-Pump~     Coronary-Artery Bypass Grafting(OP-CABG).This clinical trial is to investigate whether~     electroacupuncture(EA) anesthesia can reduce analgesic in OP-CABG surgery in distal-proximal~     group.The origins of therapeutic acupuncture can be traced back at least 2,500 years in~     China. There has been an explosion of interest in Western medicine within the United States~     and Europe in application of acupuncture technique. Acupuncture enjoys worldwide acceptance~     for treating diseases such as migraine, chronic low back pain, and knee osteoarthritis. In~     2002, WHO recommended 107 symptoms, syndromes, and diseases definitively shown to be~     effectively treated by acupuncture. Coronary heart disease (angina pectoris) is among these~     pathologies. A recent clinical trial demonstrated an acupuncture-assisted anesthesia strategy~     reduces postoperative morbidity and medical costs in open-heart surgery under cardiopulmonary~     bypass. Previous researches in animal models have demonstrated that electroacupuncture~     pretreatment protects the heart from ischemic injury. The investigators observed that~     electroacupuncture pretreatment (EAP, 30-minute electric stimulation through 4 electrodes~     attached to the bilateral forearm acupoints) before surgery significantly attenuated serum~     troponin levels during and shortly post-surgery in adult heart valve replacement patients and~     children undergoing cardiac surgery correcting congenital heart malformation.However, whether~     electroacupuncture anesthesia may reduce analgesic in OP-CABG surgery,especially in different~     combination of acupoints,has never been previously investigated.~   "
85859|NCT02443207|"~     The aim of the present study was to evaluate the perceived impact of dental caries and dental~     pain on oral health-related quality of life (OHRQoL) among preschool children and their~     families. A cross-sectional study was conduct with 843 preschool children in Campina Grande,~     Brazil. Parents/caregivers answered a questionnaire on socio-demographic information, their~     child's general/oral health and history of dental pain. The Brazilian version of the Early~     Childhood Oral Health Impact Scale was administered to determine the perceived impact of~     caries and dental pain on OHRQoL. Children have undergone an oral examination. Logistic~     regression for complex sample was used to determine associations between the dependent and~     independent variables (OR: odds ratio; α = 5%).~   "
85860|NCT02443194|"~     Primary tumor glioblastoma is the most common malignant brain. Standard treatment includes~     biopsy or excision of the tumor in order to obtain a pathological diagnosis, and tumor mass~     reduction. After the surgery patients are treated with radiation and Temodal. The most common~     psychiatric symptom in this patient population is depression, valued at up to approximately~     50% in patients with glioma . Depression not only adversely affects the quality of life of~     patients but also impairs the ability and cognitive function due to the complex clinical~     course of patients with glioblastoma. There is a tendency to give Diagnosis of depression in~     this patient population, due to a lack of awareness, knowledge and literature on the subject.~     This study was designed to prospectively randomized, controlled, double-blind study.~      This method of recruitment - patients who undergo resection or biopsy of glioblastoma (newly~     diagnosed glioblastoma), immediately after diagnosis, patients will receive an explanation~     about the study and sign a consent form will enter research.~   "
85861|NCT02443181|"~     This study evaluates the effectiveness of tremor control using various strategies for~     implementing demand-driven thalamic deep brain stimulation (DBS) for essential tremor.~     Therapeutic stimulation at the Vim nucleus of the thalamus will be initiated and modulated~     using signals derived from external sensors (e.g. EMG, accelerometer) and cortical or~     thalamic electrodes.~   "
85862|NCT02443168|"~     This is a single-center, 2-part, open-label study to evaluate the metabolism and excretion~     and absolute bioavailability of [14C]-AG-221 in healthy male subjects. It is planned for 14~     subjects to be enrolled; each subject will participate in a screening phase, a baseline~     phase, a treatment phase, and a follow up phone call. Blood, urine and fecal samples will be~     collected in Part 1 for analyses. Blood samples will be collected in Part 2. Subjects can~     only participate in either Part 1 or Part 2.~   "
85863|NCT02443155|"~     This trial is conducted globally. The aim of this trial is to assess the clinical~     proof-of-principle of NNC0114-0006 and liraglutide on preservation of beta-cell function in~     adult subjects with newly diagnosed type 1 diabetes mellitus.~   "
85864|NCT02443142|"~     Traumatic brain injury (TBI) is an important public health problem with an estimated 1.7~     million new cases in the United States each year. Although the vast majority of these victims~     sustain mild TBI, many still develop headache, difficulty concentrating, and decreased memory~     with potential for serious long-term consequences. In particular, mild TBI is an important~     consequence of combat-related injuries sustained by military personnel and sports-related~     injuries in young adults. Unfortunately, treatment of mild TBI is usually limited to oral~     analgesics for headache pain such as acetaminophen (Tylenol) or ibuprofen (Motrin or Advil).~     Since there are no previous randomized trials of these medications for mild TBI, their~     comparative effectiveness is not known. Increasing animal based evidence suggests that mild~     TBI is related to brain cell injury caused by overexpression of a cellular enzyme (COX-2)~     that causes neuroinflammation. Fortunately, inhibition of COX-2 is easily achieved using~     ibuprofen. We hypothesize that head injured patients treated with ibuprofen will have a lower~     incidence of mild TBI symptoms than patients treated with acetaminophen. We will conduct a~     randomized clinical trial to measure the comparative effects of ibuprofen versus~     acetaminophen on the incidence of specific symptoms of mild TBI in emergency department~     patients with head injury.~   "
85865|NCT02443129|"~     The investigators would be interested in applying the enhanced depth imaging technique to~     swept source optical coherence tomography, by modifying the acquisition protocol. Doing so,~     the investigators hope to improve the visualization of the choroid and perhaps even of the~     sclera.~   "
85866|NCT02443116|"~     The purpose of this study is to determine the safety, tolerability, and efficacy of NGM282 in~     patients with nonalcoholic steatohepatitis.~   "
85867|NCT02443103|"~     This study will explore the biologic activity of guanabenz in reducing bone turn over in~     solid tumor patients with bone metastasis. If successful, this repurposing of an already,~     generic drug could benefit patients faster than manufacturing a novel expensive compound.~   "
85868|NCT02443090|"~     To evaluate the safety and efficacy of fispemifene in men with secondary hypogonadism and~     sexual side effects.~   "
85913|NCT02442505|"~     This study will use an automated blood pressure monitor (Microlife WatchBP03) with an inbuilt~     algorithm to detect atrial fibrillation (an irregular heart rhythm) in patients with an~     implanted pacemaker who have previously documented paroxysmal (intermittent) atrial~     fibrillation. This study will compare the Microlife device detected atrial fibrillation~     episodes to the pacemaker detected atrial fibrillation episodes.~   "
85869|NCT02443077|"~     This randomized phase III trial studies ibrutinib to see how well it works compared to~     placebo when given before and after stem cell transplant in treating patients with diffuse~     large B-cell lymphoma that has returned after a period of improvement (relapsed) or does not~     respond to treatment (refractory). Before transplant, stem cells are taken from patients and~     stored. Patients then receive high doses of chemotherapy to kill cancer cells and make room~     for healthy cells. After treatment, the stem cells are then returned to the patient to~     replace the blood-forming cells that were destroyed by the chemotherapy. Ibrutinib is a drug~     that may stop the growth of cancer cells by blocking a protein that is needed for cell~     growth. It is not yet known whether adding ibrutinib to chemotherapy before and after stem~     cell transplant may help the transplant work better in patients with relapsed or refractory~     diffuse large B-cell lymphoma.~   "
85870|NCT02443064|"~     1. Drug resistance of G+ cocci is a severe healthcare problem. According to the Ministry of~          Health National Antimicrobial Resistant Investigation Net (mohnarin) surveillance~          report, the isolation rate of MRSA is some 60% in China. MRSA infection has become a~          serious clinical problem;~        2. Vancomycin is a bactericidal glycopeptide antibiotic which inhibits bacterial growth by~          hindering the synthesis of cell wall in bacteria. It exerts strong antibiotic effect to~          Gram+ bacteria. It is indicated for serious staphylococcus infections especially MRSA~          infection and has become the gold standard agent in MRSA treatment;~        3. Vancomycin is a time-dependent antibiotic, its clinical and microbiological efficacy is~          related to area under curve（ AUC）/minimum inhibitory concentration （MIC ）(AUIC). Cmin at~          steady state is an surrogate parameter of AUIC, which is closely associated to the~          efficacy;~        4. AUIC >400 and Cmin between 15~20 mg/L are recommended for effective vancomycin treatment~          by Infectious Diseases Society of America （IDSA） although it is still disputable;~        5. Due to the absence of PK/PD study on vancomycin in China, administration of vancomycin~          is performed in reference to the recommendation of IDSA. Its suitability to Chinese~          patients is still to be clarified;~        6. Plasma concentrations of vancomycin vary significantly between population and~          individuals. Factors such as large-volume fluid infusion, hypoproteinemia and renal~          clearance, etc. will influence the distribution and excretion of vancomycin, resulting~          in different plasma concentrations between individuals. Results of PK studies differ~          greatly between China and abroad. Administration based on the AUIC or Cmin recommended~          by IDSA would not be suitable to Chinese patients. Given the definite long-term benefit~          of vancomycin treatment, the AUIC or Cmin suitable to Chinese patients must be~          identified by clinical study.~        7. The PK/PD study on vancomycin in the treatment to MRSA septicemia and endocarditis is of~          great significance for more reasonable use and improved therapeutic efficacy of MRSA~          infection.~   "
85871|NCT02443051|"~     This research is designed to determine the effectiveness of attention bias modification for~     socially anxious children and adolescents. Over the course of 3 years, 50 youth will be~     enrolled in the trial.~   "
85872|NCT02443038|"~     This is a 2 year pilot/feasibility project to develop an intervention, test research methods,~     and evaluate the effects of yoga on core strength and balance of an older rural population in~     an effort to ultimately reduce the frequency of falls. The investigators' goal for this~     project is for community and academic partners to develop a yoga program that is feasible,~     safe, and acceptable to an older adult population, then test the program, research methods~     and evaluation, in preparation for conducting a larger randomized trial of the intervention.~   "
85873|NCT02443025|"~     This study evaluates the efficacy of Teens Against Tobacco Use anti-tobacco presentations on~     tobacco use susceptibility in 4th-8th grade. Classrooms are randomly assigned to either~     receive a series of two presentations or wait listed to receive them later in the school~     year.~   "
85874|NCT02443012|"~     Diabetic macular edema (DME) is a major cause of visual loss in patients with diabetes~     mellitus. The standard treatment is with focal/grid laser therapy. Topical nepafenac was used~     as an adjunct therapy for treatment of DME.~      The aim of this study is to compare the difference of best corrected visual acuity (BCVA) and~     central macular thickness (CMT) at 3 months post treatment between combination therapy of~     laser and topical nepafenac and laser monotherapy in patients with DME.~   "
85875|NCT02442999|"~     Randomized clinical trial among women with polycystic ovary syndrome (PCOS) who present for~     fertility treatment to evaluate the impact of screening for obstructive sleep apnea.~   "
85876|NCT02442986|"~     Systemic inflammation and sepsis cause multi organ failure including severe neurologic~     impairment in the course of disease. Neurologic failure typically presents as~     critical-illness-polyneuropathy/-myopathy and septic encephalopathy during sepsis and is~     associated with an increased mortality rate.~      Clinical parameters to determine the neurologic entities during the course of sepsis are~     heterogeneous. Further research for an association of clinical parameters and the patients'~     outcome is needed.~      The study aims toward differences in the clinical and neurological outcome of surgical and~     non-surgical septic patients in comparison to non-septic patients on ICU. The aim of the~     study is to identify clinical and diagnostic outcome predictors in septic patients.~   "
85877|NCT02442973|"~     Currently, at UVA, handheld ultrasound devices (like those used to view an unborn baby) are~     only two dimensional. The Accuro is a three dimensional handheld ultrasound device. This~     device uses sound waves to create pictures of the spine in three dimensions. This may allow~     the physician to view the spine in more detail for procedures such as spinal anesthesia and~     other diagnostic procedures. Epidural analgesia is the mainstay procedure for the management~     of labor pain. The precise placement of a needle or catheter in proximity to landmarks of the~     spinal bone anatomy is required for the procedure to succeed. The current standard of care is~     called the 'blind approach' (i.e. without medical imaging) and involves a physician manually~     palpating a patient's back to locate spinal bone landmarks. The needle is then inserted with~     respect to the location of the landmarks and inserted until a loss-of-resistance is manually~     detected. This approach, while most common, has been associated with success rates as low as~     68% in obese patients (2).~      Alternative methods have been investigated for this problem, including ultrasound (US)~     guidance, which offers real-time imaging. Several studies have demonstrated ultrasound's~     efficacy for spinal anesthesia (1-6). However, standard US systems are engineered to image~     soft tissue rather than bone structures, with the consequence that bone is imaged poorly. US~     images are often degraded by a number of noise sources including speckle noise,~     reverberations and off-axis scattering, particularly when bone is present, making~     visualization of bone anatomy features difficult. Moreover, arranging access to ultrasound~     for the purpose of spinal anesthesia alone is cumbersome. Thus, the efficacy of guided spinal~     anesthesia and diagnostic procedures using standard ultrasound systems is limited and the~     benefits that it offers are heavily dependent on the user's familiarity and skill with~     ultrasonography (4).~      Recently, new medical imaging technologies have been developed at Rivanna Medical, LLC to~     address the significant clinical need for technological advances that improve the placement~     of spinal anesthesia, epidural analgesia and other diagnostic procedures. The Accuro is a~     pocket-sized and battery operated ultrasound instrument that incorporates new signal~     processing-based technologies for enhanced bone imaging including 3D navigation of the lumbar~     spine. The device is a single self-contained unit consisting of an ultrasound system,~     ultrasound probe, and rotatable touchscreen display. The instrument enables a SpineView3D™~     technology to facilitate spinal anesthesia guidance with real-time 3D navigation of the~     lumbar spine anatomy.~      SpineView3D™ technology facilitates image interpretation of individual 2D lumbar spine scans~     by automating spinal bone landmark detection and depth measurements and providing a real-time~     assessment of scan plane orientation in 3D. SpineView3D™ makes image interpretation and~     measurements of the lumbar spine anatomy simple, quick, and easy. Real-time 2D scans from~     either SpineView3D™ or general-purpose bone presets are formed using patent-pending~     BoneEnhance+™ technology. The BoneEnhance+™ technology provides images of bone anatomy at~     greater bone-to-tissue contrast compared with conventional ultrasound image reconstructions.~   "
85878|NCT02442960|"~     This is a 12-week, open-label, dose-escalation Phase 1b study of a herbal treatment given~     orally to subjects with ulcerative colitis. Subjects will be sequentially enrolled to one of~     two cohorts in up to two clinical sites. Treatment will be given for 8 weeks and study~     duration will be 12 weeks.~   "
85879|NCT02442947|"~     Using protective or combat garments under heavy heat stress conditions, during rest or~     exertion, may hinder the body`s ability to effectively exchange heat with the environment and~     thereby can lead to heat injuries. The purpose of this research is to physiologically examine~     the new textile solutions that are planned to be integrated in the protective garments,~     combat garments and work uniforms in the army, by evaluating the physiological stress~     obtained during exertion under hot climatic conditions.~   "
85880|NCT02442934|"~     Since critically ill patients are exposed to stressful conditions, the investigators~     evaluated the effectiveness of a multicomponent program to reduce perceived discomforts in~     the Intensive Care Unit (ICU) .~   "
85881|NCT02442921|"~     Forty patients with diabetic nephropathy will be treated with colchicine up to 2 mg, or~     placebo, for 18 months. A follow up will be performed after 12 additional months. The primary~     outcome will be a significant reduction or stabilization of proteinuria during the 18 month~     treatment period.~   "
85882|NCT02442908|"~     SF-K002 is a pilot study in patients with moderate to severe COPD suffering from involuntary~     weight loss. The study is 12 weeks, double-blinded, placebo controlled and the main objective~     is to study the safety and tolerability of Nutrifriend Cachexia.~   "
85883|NCT02442895|"~     Retrospective study to evaluate the correlation between AFC, FSHb, AMH and IVF outcomes of~     347 cycles performed with three different protocols.~   "
86300|NCT02437448|"~     The aim of the study is to answer the question whether a disease specific profile of breath~     in patients with idiopathic lung fibrosis can be detected by an untargeted metabolomic study~     using exhaled breath analysis by mass spectrometry.~   "
85885|NCT02442869|"~     This pilot study will test the feasibility of utilizing an adaptive intervention strategy for~     college students who are suicidal when first seeking treatment at a campus clinic. Right now,~     the typical strategy may rely on a one size fits all approach, but in fact suicidal~     students vary greatly on what and how much they need. This study would allow clinical~     decision making (trying one approach, and if that doesn't work, another) to be empirically~     developed and tested in a subsequent large-scale multisite trial with the goal of maximizing~     resources in overburdened college counseling centers. If the aims of this project are~     achieved, this pilot study and a subsequent large-scale trial could eventually significantly~     impact service delivery to suicidal college students at college counseling centers.~   "
85886|NCT02442856|"~     The overall objective of this study is to evaluate the use of diffuse correlation~     spectroscopy to non-invasively measure dynamic cerebral autoregulation in subjects with~     vascular risk factors. Optical cerebral blood flow measurements will be correlated with~     changes in arterial blood pressure to assess how CBF is maintained in response to changes in~     ABP, and will be compared to transcranial doppler reference measurements.~   "
85887|NCT02442843|"~     This study is designed to identify changes in the brain that underlie symptoms of~     combat-related PTSD using brain imaging (fMRI). Then, the investigators will administer mild~     electrical stimulation to the side of the head (using a method called tDCS) in an attempt to~     reduce the symptoms of PTSD.~   "
85888|NCT02442830|"~     The objectives of this study are to test whether there are statistically significant~     differences between the standard of care workup workup of non-hematemesis gastrointestinal~     bleeding by endoscopy [upper, lower and other tests], compared with deployment of a video~     capsule as the first test followed by the most appropriate endoscopic procedure based on~     video capsule findings, if needed. The investigators propose to examine differences in time~     to diagnosis, reduction in numbers of procedures, and length of stay between a standard of~     care workup protocol and our proposed protocol of early capsule endoscopy deployment.~   "
85889|NCT02442817|"~     The purpose of the present study is to gather pilot data on the effects of linagliptin on the~     concentration of the long and short forms of SDF1-α (stromal cell-derived factor alpha) in~     humans, and to demonstrate the feasibility of such a study in patients with psychosis in our~     setting.~   "
85890|NCT02442804|"~     The purpose of this study is to determine whether pomegranate supplements improve cognitive~     functioning following stroke.~   "
85891|NCT02442791|"~     Experimental studies and previous clinical trials suggest neuroprotective effects of GLP-1~     analogs in various degenerative neurological diseases, and in hypoxic brain injuries in~     experimental designs. This study is designed as a safety and feasibility study with patients~     randomized 1:1 to receive GLP-1 analogs immediately after hospital admission after out of~     hospital cardiac arrest.~   "
85892|NCT02442778|"~     Participants with agitation secondary to dementia of the Alzheimer's type. The diagnosis of~     probable Alzheimer's disease (AD) will be based on the 2011 Diagnostic Guidelines for~     Alzheimer's Disease issued by the National Institute on Aging (NIA)-Alzheimer's Association~     (AA) workgroups.~   "
85893|NCT02442765|"~     Participants with agitation secondary to dementia of the Alzheimer's type. The diagnosis of~     probable Alzheimer's disease (AD) will be based on the 2011 Diagnostic Guidelines for~     Alzheimer's Disease issued by the National Institute on Aging (NIA)-Alzheimer's Association~     (AA) workgroups.~   "
85894|NCT02442752|"~     The purpose of this study is to assess the pharmacokinetics (PK) and pharmacodynamics (PD)~     [after daily administration for 7 days] and safety [after daily administration for 8 weeks]~     of dexlansoprazole in pediatric participants aged 1 to 11 months, inclusive, with~     acid-related diseases.~   "
85895|NCT02442739|"~     The primary purpose of this study is to see if it is safe to give patients with pancreatic or~     head and neck cancer a low dose of the FDA approved anesthetic drug ketamine at the same time~     they receive radiation and/or chemotherapy for their cancer treatment to prevent depression~     and its effects. Researchers would also like to see if giving ketamine at the same time as~     cancer treatment is practical and reasonably acceptable to the patient.~      New onset depression is highly frequent in those with head and neck cancer, and depression~     has many negative consequences for outcomes in those patients. Depression has been known to~     have greater incidence in pancreatic cancer patients than in patients with other~     malignancies.~      Therefore, investigators would also like to see if giving patients ketamine during their~     routine cancer treatment will prevent the onset of depression and its negative effects on~     cancer treatment outcomes, and also help with anxiety, pain, and quality of life. The study~     will also use a placebo to compare to the good and/or bad effects of ketamine. A placebo is~     not an active drug and it will be look the same as ketamine, as a liquid to be taken by~     mouth.~      Ketamine is approved by the U.S. Food and Drug Administration (FDA) as a general anesthetic~     by itself for some diagnostic and surgical procedures or combined with other general~     anesthetic agents. It has also been shown to reduce cancer pain. Ketamine is considered~     experimental in this study because it is not approved by the FDA for the prevention of~     depression.~   "
85896|NCT02442726|"~     The aim of this study is to measure reaction times and thermal detection thresholds to CO2~     laser stimulation of the skin, before and after a first degree thermal injury, in the primary~     and secondary hyperalgesia area, in order to investigate whether different nerve-fiber~     classes are activated in the post-injury phase. The study results are expected to uncover~     existence of a peripheral inflammatory input contributing to secondary hyperalgesia.~   "
85910|NCT02442544|"~     The gut microbiome is increasingly recognized as a contributor to disease states. In type 1~     diabetes, alterations in gut microbiota may be linked to changes in intestinal permeability,~     inflammation and insulin resistance. Prebiotic fiber is a dietary supplement that alters gut~     microbiota and could potentially improve insulin sensitivity in children with type 1~     diabetes. This pilot study aims to determine the feasibility of a 12-week dietary~     intervention with prebiotic fiber in children with type 1 diabetes. The investigators~     hypothesize that consumption of prebiotic fiber will alter gut microbiota and intestinal~     permeability, leading to improved glycemic control. Prebiotic fiber is a potentially novel,~     inexpensive, low-risk treatment addition for type 1 diabetes that may improve glycemic~     control by changes in gut microbiota, gut permeability and inflammation.~   "
85911|NCT02442531|"~     The goal of this Phase1 clinical research study is to find the highest safe dose of CriPec®~     docetaxel that can be given in the treatment of patients with solid tumours.~   "
85897|NCT02442713|"~     Major depressive disorder is associated with several sleep Polysomnograph (PSG) findings: (1)~     impaired sleep continuity; (2) non-REM (NREM) changes; and (3) enhanced rapid eye movement~     (REM) sleep. The first two patterns are common in other psychiatric disorders, while the REM~     pattern is very characteristic in depression, so the phase-advance theory was accepted by~     most of psychiatrists. Many researchers have focused on the biological rhythm to investigate~     the etiological and pathophysiology of depression, and they think depression can be cured if~     its sleep abnormality is ameliorated.~      It is well known that most of antidepressants treat depression through 5-hydroxytryptamine~     (5-HT) neurons. 5-HT also affects the regulation of the sleep-wake cycle and the sleep~     microarchitecture. Many all-night PSG studies have shown tricyclic antidepressants can~     ameliorate the sleep architecture abnormality in depression by producing rapid suppression of~     REM sleep.~      Compared to TCAs, SSRIs are generally less sedating because of its high selectivity for~     serotonin receptors. On the other hand, it is known that, although all of SSRIs mainly~     increase the extracellular serotonin level by inhibiting serotonin transport in the~     presynaptic neuron, each SSRI has its unique pharmacological characteristics. For example, it~     was reported by accumulating researches that the serum melatonin level increased markedly~     after ingestion of fluvoxamine. The mechanism behind this effect is unknown, but one~     possibility is increased melatonin synthesis, caused by effects on serotonin, which is a~     melatonin precursor. Another possibility is that fluvoxamine inhibits the metabolism of~     melatonin in the liver.~      Thus, the property of fluvoxamine to increase serum melatonin level, or even recover the~     circadian rhythm of melatonin in depressed patients, might improve the clinical outcome by~     improving the sleep quality and quantity. By now, the changes of sleep architecture in~     fluvoxamine treatment were assessed by only three clinical trials, and their results were~     contradictive. This discrepancy might be due to the small sample size and different study~     design, such as clinical trial duration. Moreover, two of three researches applied home-based~     PSG assessment, which might have distorted the results of sleep architecture to some extent.~     Thus, the effects of fluvoxamine on sleep architecture need to be clarified by more clinical~     trials with standard PSG assessment.~   "
85898|NCT02442700|"~     Dyslipidemia as a risk factor for cardiovascular disease (CVD) is an increasing problem in~     HIV-infected patients who are on antiretroviral therapy especially protease inhibitors~     including atazanavir. Pitavastatin is a new HMG-CoA reductase inhibitor with lesser drug-drug~     interactions and demonstrable efficacy in decreasing lipid levels in non HIV-infected~     individuals. The study was conducted as a randomized, double-blind, crossover study comparing~     the safety and efficacy of pitavastatin versus placebo in HIV-infected patients with~     dyslipidemia and receiving atazanavir/ritonavir. Patients were randomized to receive either~     placebo or pitavastatin for 12 weeks, underwent a 2-week washout period, and then were given~     the other treatment for an additional 12 weeks. Patients were observed for lipid profiles~     including total cholesterol (TC), triglyceride (TG), low density lipoprotein (LDL) and high~     density lipoprotein (HDL); and the side effects including clinical and laboratory (serum~     aspartate aminotransferase (AST), alanine aminotransferase (ALT) and creatinine phosphokinase~     (CPK)). The follow-up visits were every 4 weeks until the end of the study.~   "
85899|NCT02442687|"~     To evaluate the safety and potential efficacy of two dose levels of JKB-121 (5 mg twice daily~     and 10 mg twice daily) in reducing liver fat and/or liver biochemistry compared to placebo in~     patients with biopsy-proven nonalcoholic steatohepatitis~   "
85900|NCT02442674|"~     The purpose of this trial is to demonstrate that tolvaptan effectively and safely increases~     and maintains serum sodium concentrations in children and adolescent subjects with euvolemic~     or hypervolemic hyponatremia.~   "
85901|NCT02442661|"~     This research study is performed to compare the accuracy of two methods of lymph node~     evaluation: research method versus standard method. Standard method is what is usually~     performed as standard of care where the radiologist evaluates the images overall and decides~     whether each node seen should or should not be biopsied. In the research method, a second~     radiologist will evaluate the ultrasound images of the lymph nodes separately, and use a~     small specific checklist of ultrasound appearance to determine whether each node should or~     should not be biopsied. Results of both the standard and research method will be used to~     decide which node(s), if any should be biopsied. Neck ultrasound examination, lymph node~     evaluation by standard method and subsequent lymph node biopsy are part of the standard~     clinical care. It is less likely but possible that the research method may identify~     additional lymph nodes for biopsy to check if that lymph node contains thyroid cancer.~   "
85902|NCT02442648|"~     The primary purpose of this study is to provide a preliminary evaluation of the safety and~     potential efficacy of carfilzomib in reducing HLA antibody levels in highly sensitized kidney~     transplant candidates.~   "
85903|NCT02442635|"~     This proposal aims to expand non-pharmacologic options for the control of symptoms during~     chemotherapy using yoga practices. It is particularly focused on sleep disturbance with a~     secondary focus on fatigue.~   "
85904|NCT02442622|"~     To determine if the addition of Astym treatment to traditional therapy produces a more~     positive outcome then traditional therapy alone for the treatment of de Quervain's~     tenosynvitis. Two groups will be examined with one group receiving traditional therapy and~     the other group receiving traditional therapy in addition to Astym treatment protocol.~   "
85905|NCT02442609|"~     Patients need information for perioperative period and internet may be an interesting~     alternative.This study analysed by questionaire what does patient look on internet:~     information of perioperative period and specifically for anesthesia. Questionaire (8~     questions) are distributed to the patient before surgery and after they were prepared by~     surgeon. Population : adult (> 18 y), no emergency procedure.The mean question is the use of~     internet for anesthesia information.~   "
85906|NCT02442596|"~     The aim of the project is to perform a multinational, prospective, observational study on~     IAIs (IntraAbdominal Infections) in critically ill patients; special emphasis will be given~     to epidemiology and outcomes.~   "
85907|NCT02442583|"~     Interview colorectal cancer survivors and use this input to create a brochure intended to~     guide reduction of sedentary behaviors in this population. Have colorectal cancer survivors~     review and comment on a draft of the brochure. A third group of colorectal cancer survivors~     will wear an Actigraph activity monitor for one week, then receive feedback on their activity~     level with the brochure. After one month this group will be surveyed by telephone regarding~     their use of the brochure, and their physical activity level.~   "
85908|NCT02442570|"~     The purpose of this study is to evaluate safety and clinical efficacy of DC-TAB in multiple~     sclerosis.~   "
85909|NCT02442557|"~     The purpose of this study is to determine safety and appropriate dose of DC-TAB for selective~     immune tolerance induction in humans.~   "
85912|NCT02442518|"~     The accuracy of sonographic prenatal detection of invasive placentation is unclear. The~     objective of this prospective, multicenter, observational study is to assess the performance~     of ultrasound for prenatal identification of invasive placentation in women with placenta~     previa.~      This study involves more than 25 hospitals in Italy.~   "
85914|NCT02442492|"~     Early-onset placental intrauterine growth restriction (EO IUGR) is associated with a high~     risk of perinatal morbidity and mortality. In association with reduced circulating placental~     growth factor (PlGF) EO IUGR results from abnormal placentation with inadequate remodelling~     of the maternal uteroplacental arteries. There is no known treatment for placental IUGR.~     Management involves intensive fetal surveillance with delivery with evidence of serious fetal~     compromise. However, remote from term, delivery is associated with significant perinatal~     mortality and morbidity. Sildenafil vasodilates the uteroplacental vessels of IUGR-affected~     pregnancies and may represent a novel therapy.~   "
85915|NCT02442479|"~     Resistance training has shown the most promise among interventions aimed to combat aging~     muscle atrophy as it enhances strength, power, and mobility function, but induces varying~     degrees of skeletal muscle hypertrophy as the investigators demonstrated in the initial~     5-year funding period of this award (2001-2006). In the subsequent 5-year funding period~     (2007-2012), the investigators built on this prior work by using a dose-response approach in~     older adults - ultimately to optimize the treatment of age-related muscle atrophy. The~     investigators tested four, long-term resistance training prescriptions in older (60-75 yr)~     women and men to determine which prescription maximizes mechanisms driving muscle regrowth.~     One of the innovations in this project was the use of a 4-wk pre-training program to reach a~     plateau in the early, non-muscle mass adaptations, thereby establishing a true baseline from~     which both mechanisms of measurable muscle hypertrophy and functional consequences of~     hypertrophy could be studied in a tightly integrated fashion without bias in the subsequent~     experimental period. A randomized design was used to test the overarching hypothesis that a~     novel program of mixed strength and power training would optimize the anabolic environment to~     promote muscle hypertrophy and robust gains in performance. This hypothesis was tested with~     three specific aims.~   "
85916|NCT02442466|"~     Intra-lesion administration of an Endothelin Receptor B inhibitor (BQ-788) or vehicle was~     preformed in 5 melanoma patients to have a preliminary analysis of safety, dose, duration and~     relevance of results observed in pre-clinical studies to the human disease.~   "
85917|NCT02442453|"~     Periodontitis is initiated by microbial biofilm but its progression is mediated by an~     abnormal host response to biofilm microorganisms.~      In a myriad of possible mechanisms that cause periodontal tissue destruction reactive oxygen~     species (ROS) play an important role. Imbalance between antioxidant defense system of body~     and ROS lead to a deleterious situation called oxidative stress.~      Superoxide dismutase (SOD) is the key enzyme of body's antioxidant defense system whereas~     malondialdehyde (MDA) is product of lipid peroxidation due to ROS. Free radicals and ROS have~     short half lives in vivo of 10-6 to 10-9 seconds. Hence measurement of ROS is done by~     measuring the concentration of biomarkers of tissue destruction.~      For treating periodontal disease, conventional mechanical therapy comprising of scaling and~     root planing (SRP) along with timely maintenance has been a gold standard and any other~     therapy considered for treating periodontitis should always be used as an adjunctive and~     never in lieu of it.~      Curcumin, a hydrophobic polyphenol, is a principal active constituent of turmeric. Mechanism~     of action of curcumin is twofold-its role as a strong antioxidant and as a strong~     antibacterial. Its analgesic, anti-inflammatory and antiseptic properties offer additional~     benefits.Periodontitis is a chronic disease of oral cavity accompanied by increased oxidative~     stress. Therefore the clinical application of a natural antioxidant in the form of curcuma~     longa can be beneficial in reducing oxidative stress and as an adjuvant in treatment of~     chronic periodontitis.~   "
85918|NCT02442440|"~     Anisodamine has been widely used in China for its pharmacological effect on improving~     microcirculation during shock. It has been reported that anisodamine is effective in reducing~     mortality rate in children with meningitis. however, its effectiveness in patients with~     septic shock has not been systematically investigated. The aim of the study is to investigate~     the effectiveness of anisodamine in the treatment of patients with septic shock.~   "
85919|NCT02442427|"~     There is a growing body of literature suggesting that monoclonal antibody could be~     efficacious in infants with RSV-bronchiolitis, well tolerated with no or clinically~     insignificant adverse effects.~      The investigators hypothesize that a single dose of iv palivizumab 15 mg/kg in diagnosed~     infants <3 months old with RSV bronchiolitis will result in fewer infants with readmissions~     to infirmary/observation or hospital for relapse during 3 weeks of follow-up after~     discharge.~   "
85920|NCT02442414|"~     The purpose of this study is to determine the maximum tolerated dose of KBP-5209 as a single~     agent when given orally to adult patients with advanced solid tumors that have progressed~     despite standard therapy, or where there is no standard therapy.~   "
85921|NCT02442401|"~     The use of NPWT as a post-operative dressing significantly reduces the incidence of seroma~     formation after harvesting LD flap.~   "
85922|NCT02442388|"~     The purpose of this prospective, randomized, double-blind study was to compare the~     prospective pain in asymptomatic mandibular molar teeth with necrotic pulp and periapical~     lesion using three different instrumentation files: Hand, Protaper Universal, and Wave-One~     files.~   "
85923|NCT02442375|"~     The objective of the UPGRADE-RT trial is to investigate whether de-escalation of elective~     radiation dose and introduction of an intermediate dose-level in the treatment of head and~     neck cancer will results in less radiation sequelae and improved quality of life after~     treatment whilst the recurrence rate in electively irradiated lymph nodes should not be~     compromised.~      A summary of the study protocol can be found here: http://rdcu.be/qgMv~   "
85924|NCT02442362|"~     This study was designed to compare the efficacy and safety of~     aclitaxel/oxaliplatin/fluorouracil (TOF) regimen and S-1/oxaliplatin (SOX) regimen for~     metastatic gastric cancer (GC) patients.~   "
85925|NCT02442349|"~     A Phase II, Open Label, Single-arm Study to Assess the Safety and Efficacy of AZD9291 in Asia~     Pacific Patients with Locally Advanced/Metastatic Non-Small Cell Lung Cancer whose Disease~     has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor~     Therapy and whose Tumours harbour a T790M mutation within the Epidermal Growth Factor~     Receptor Gene~   "
85926|NCT02442336|"~     The overall goal is to develop and examine the acceptability of a web-based (Internet)~     intervention program for patients with head and neck cancer who have recently completed~     radiation therapy.~   "
85927|NCT02442323|"~     Despite evidence regarding the benefits of physical activity in various cancer patient~     populations, the effects of a home-based walking program for pancreatic cancer patients have~     been under-explored. The aims of the proposed pilot project are to: (1) Assess the~     feasibility of implementing a 12-week, home-based walking program among pancreatic cancer~     patients; and (2) Examine the effects of a 12-week, home-based walking program on quality of~     life (QOL) and symptoms among pancreatic cancer patients.~   "
85928|NCT02442310|"~     The purpose of this study is to look at the pharmacokinetics of a new formulation of~     deferiprone (deferiprone delayed release tablets) under fed and fasting conditions.~   "
85929|NCT02442297|"~     This study is for patients that have a type of brain cancer called Glioblastoma (GBM). The~     body has different ways of fighting infection and disease. No single way seems perfect for~     fighting cancers. This research study combines two different ways of fighting cancer:~     antibodies and T cells. Antibodies are types of proteins that protect the body from~     infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special~     infection-fighting immune cells present in the blood that can kill other cells, including~     cells infected with viruses and tumor cells. Both antibodies and T cells have been used to~     treat patients with cancers. They have shown promise, but have not been strong enough to cure~     most patients.~      The antibody used in this study is called anti-HER2 (Human Epidermal Growth Factor Receptor~     2). This antibody sticks to GBM cells because of a substance on the outside of these cells~     called HER2. Up to 80% of GBMs are positive for HER2 . HER2 antibodies have been used to~     treat people with HER2-positive cancers. For this study, the HER2 antibody has been changed~     so that instead of floating free in the blood it is now attached to T cells. When an antibody~     is joined to a T cell in this way it is called a chimeric antigen receptor (CAR). These CAR-T~     cells seem to be able to kill tumors like the one these patients have, but they don't last~     very long and so their chances of fighting the cancer are limited. Therefore, developing ways~     to prolong the life of these T cells should help them fight cancer.~      These HER2-CAR T cells are an investigational product not approved by the Food and Drug~     Administration.~      The purpose of this study is to find the largest safe dose of HER2-CAR T cells, to learn what~     the side effects are, and to see whether this experimental intervention might help patients~     with GBM who volunteer to test this new agent.~   "
85930|NCT02442284|"~     The purpose of this study is to evaluate the safety and efficacy of~     ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in US veterans with~     genotype 1 chronic hepatitis C virus infection.~   "
85931|NCT02442271|"~     The purpose of this study is to evaluate the proportion of subjects achieving sustained~     virologic response 12 weeks post-treatment (SVR12) in adults with genotype 1 (GT1) chronic~     HCV infection, who received treatment with 3 direct-acting antiviral agents (3-DAAs;~     ombitasvir/paritaprevir/ritonavir and dasabuvir) with or without ribavirin.~   "
85932|NCT02442258|"~     This is an open-label, single dose study designed to assess the pharmacokinetics and safety~     of ABT-493 and ABT-530 in subjects with either normal renal function or impaired renal~     function.~   "
85933|NCT02442245|"~     Part one of this study will consist of baseline (BL) testing, 28 days of daily~     supplementation with XSurge, and an exercise protocol. The acute exercise protocol consists~     of five visits, of which, the first visit will consist of maximal strength testing. The~     remaining visits will consist of performance testing and muscle evaluation.~      Phase two of this study will consist of six weeks of supervised resistance training along~     with supplementation of XSurge. Following the six weeks of training, subjects will complete a~     second acute exercise protocol. Measures to be evaluated will consist of performance testing~     and muscle evaluation.~   "
85934|NCT02442232|"~     The purpose of this study is to evaluate biomarkers affecting the hemodynamic responses to~     propofol. Particularly, the investigators will assess the effects of polymorphisms in NOS3~     and PRKCA genes on hemodynamic responses to propofol and the effects of these polymorphisms~     on biomarkers related to nitric oxide after propofol anesthesia. In addition, the~     investigators will evaluate the effects of propofol anesthesia on biomarkers related to~     nitric oxide in hypertensive patients chronically treated with angiotensin-converting enzyme~     inhibitors.~   "
85935|NCT02442219|"~     Persons with coeliac disease treated with a gluten free diet will be asked to give blood for~     a new diagnostic blood test. In this test investigators will use multimerized HLA bound to~     different gliadin-peptides (tetramer) and with the help of a flow-cytometer identify (along~     with other relevant T-cell-markers) gluten specific T-cells. Investigators believe that these~     cells will be present in persons with coeliac disease regardless of gluten-intake.~     Investigators will compare their findings with two control groups; Persons on a gluten free~     diet where celiac disease is excluded (gluten sensitive group) and persons on a gluten~     containing diet (healthy control group). In the initial and main study investigators will~     look at HLA DQ2.5 individuals, which comprise >90% of all persons with coeliac disease.~   "
85936|NCT02442206|"~     This mechanistic study is a single-center, randomized, double-blind, placebo-controlled,~     cross-over study to evaluate the effect of dual bronchodilation with QVA149 on cardiac and~     lung function parameters in hyperinflated COPD patients.~   "
85937|NCT02442193|"~     The overall aim of the study is to assess the feasibility of conducting a Randomized~     Controlled Trial (RCT) to evaluate the effectiveness of Individual Placement and Support~     (IPS) in improving employment rates and associated psychosocial outcomes in forensic~     psychiatric populations.~   "
85938|NCT02442180|"~     Steroid is the treatment of choice in patients with severe alcoholic hepatitis. However,~     null- or partial responder of steroid treatment is recommended to consider liver~     transplantation. The yearly demand for liver transplants far exceeds the supply of available~     organs and alcoholic liver disease has been a controversial indication for transplantation.~     Granulocyte-Colony Stimulating Factor (G-CSF) has been reported to have effect of~     proliferation of hepatic progenitors in alcoholic steatohepatitis. The aim of this study is~     to investigate the efficacy of G-CSF in patients with severe alcoholic hepatitis with null or~     partial response to steroid.~   "
85939|NCT02442167|"~     Fluorescence in situ hybridization (FISH) has improved the diagnostic performance of cytology~     for evaluation of malignant biliary strictures in the US and Europe. The utility of FISH for~     diagnosis of biliary strictures in Asia is currently unknown. The investigators conducted a~     prospective study in 2 university hospitals to determine diagnostic performance of FISH for~     the diagnosis of malignant biliary strictures in Thai patients.~   "
85984|NCT02441569|"~     This trial examines the effectiveness of training pediatric primary care providers (nurse~     practitioners, doctors) to use of strategies that enhance family/youth empowerment and~     engagement during office visits for children with mild to moderate problems with anxiety.~     Children coming for routine care at one clinic are screened for anxiety symptoms and seen by~     either a specially trained provider or one of the clinic's other regular staff members.~   "
85940|NCT02442154|"~     Severe head injury is associated with airway compromise and poor respiratory effort. In~     Mulago Hospital intubation is the mainstay intervention and then patients are subjected to~     the wait and see strategy of delayed or no tracheostomy, very few undergo early tracheostomy,~     and some patients are left without an artificial airway.Using endotracheal tubes is~     associated with complications which have been shown to increase intensive care unit (ICU) and~     hospital stay, morbidity and mortality.~      Tracheostomy has been reported to have advantages over translaryngeal intubation but the~     optimal timing of tracheostomy in patients with severe head injury is controversial. Studies~     done elsewhere have showed that patients with severe head injury who undergo early~     tracheostomy have better survival outcomes but no studies have been done in our setting~   "
85941|NCT02442141|"~     The purpose of this research study is to examine the effects of routine anesthesia on infant~     brain oxygen levels. The investigators do not know how anesthesia effects blood flow in the~     brain of infants during surgery. This study will help the investigators detect possible blood~     flow changes in the brain for infants undergoing anesthesia. A monitor and sensors (NIRS or~     near-infrared spectroscopy) which use light to measure oxygen levels in the blood will be~     used. Sensors will rest on the child's skin and record measurements before, during and after~     the surgery.~   "
85942|NCT02442128|"~     Several methods have been proposed to improve intubating conditions and minimize sevoflurane~     induction time during sevoflurane induction in children. These include clonidine~     premedication, [5] addition of nitrous oxide, [6] opioids, [7,8] or propofol [9].~      Four Studies evaluated sevoflurane alone for intubation (9-12).Aim of this study: is to~     evaluate the effects of two different dose of propofol preceded by a fixed dose of fentanyl~     during sevoflurane induction on quality of tracheal intubation in children undergoing~     elective surgery.~   "
85943|NCT02442115|"~     The clinical manifestation of autism spectrum disorder (ASD) is complex, with medical and~     mental health disruptions that occur with the three core behavioral criteria used for~     diagnosis (social behavior, communication, restricted interests/repetitive behavior).~     Co-occurring medical conditions, such as gastrointestinal dysfunction (GID), often are~     overlooked when designing research strategies to understand the mechanisms underlying the~     expression of ASD. This study was initially a collaboration between Children's Hospital Los~     Angeles (CHLA) and the Children's Hospital at Vanderbilt University. The current research~     project proposes to recruit subject at CHLA and the Center for Autism and Developmental~     Disorders (CAND), a Children's Hospital of Orange County and University of California Irvine~     (UCI) Health collaborative program. In Aim 1, the investigators will characterize GID in~     pediatric populations with ASD. Over a 12 month period, subjects will receive standard of~     care for their GID, typically functional constipation. The study population will be~     characterized with a standardized instrument for diagnosing functional GI disorders in~     children, the Questionnaire on Pediatric Gastrointestinal Symptoms, and with the clinical~     acumen of an experienced pediatric gastroenterologist. Nutritional information also will be~     collected to determine whether there are patterns of GIDs that correlate with dietary and~     nutritional status. The in-depth characterization and treatment of GIDs in children with ASD~     will provide a unique way of determining if ASD symptom and GID symptom improvement are~     related to each other. In Aim 2, the investigators will do in-depth assessment of each~     subjects functional status for social communication, emotional regulation, cognitive~     function, speech-language, sensory integration, and a biomarker of oxidative stress. The~     latter will be measured in urine samples over the course of one year. There are no direct~     interventions for autism symptoms in this study. Rather, subjects will receive standard of~     care for the GID diagnosis and secondary effects on ASD symptoms will be evaluated. Our power~     calculation shows that the investigators will be adequately powered with the proposed study~     design and recruitment targets. As part of the study, the investigators have developed a~     collaboration with investigators in the University of Southern California (USC) School of~     Engineering, in which the investigators will work with them to develop computational tools to~     assist in the characterization of videotaped Autism Diagnostic Observation Schedule (ADOS-2)~     assessments.~   "
85944|NCT02442102|"~     An early intervention for swallowing disorders (i.e., dysphagia) during endotracheal~     intubation may improve patient outcomes. The investigators propose treatment sessions~     targeting sensorimotor integration, strength, and range of motion during oral endotracheal~     intubation with mechanical ventilation to reduce or prevent dysphagia and aspiration (food or~     liquids entering the airway), establish a solid foundation in understanding reasons for~     swallowing impairment after extubation from mechanical ventilation and learn new methods to~     reduce or prevent these problems.~   "
85945|NCT02442089|"~     Missed health care appointments present a serious challenge to patient care. Especially in~     government funded health systems like that of Chile, missed appointments can lead to delayed~     care, wasted resources, and escalating costs.~      This private-public-research collaboration seeks to provide a rigorous, practical evaluation~     of a new patient reminder system, evaluate how health beliefs impact patient attendance, and~     capture the potential for scaling up this or other health technology systems. Using a~     mixed-methods approach this study will provide contextualized, triangulated analysis of~     pediatric patient attendance in Chile.~   "
85946|NCT02442076|"~     Skin tremor induced by artery pulses are usually sensed by doctor's fingers in Traditional~     Chinese Medicine(TCM). On the other hand, vibration of acupuncture needle was also stated by~     Huang Di Nei Jing (Yellow Emperor). However; the characteristics of skin tremor and its~     correlation with vibrating acupuncture needles, how the skin tremor and vibration of needles~     varies from area to area, are not yet clarified.In this study, the abovementioned issues will~     be investigated experimentally through non-invasive method.~      About 10 healthy volunteers, aged 20~65, will be recruited. The investigators will measure~     the needle and the skin tremor by video optical microscopy. The variation of skin tremor and~     needle vibration and their spectra will be analyzed digitally. The model correlating skin~     tremor, needle vibration and basic physiological parameters will be constructed.The fact that~     the skin tremor and the needle vibration come from the same origin is expected.~      However; due to the leverage effects and different dynamical responses to the source~     vibrations at different frequencies, needle vibration might exhibit some difference from skin~     vibration in their power spectra. This study should be able to construct a clear model of the~     possible vibration sources such as heartbeat and breathing, the area dependence of~     vibrations, the correlation between the skin and the needle vibrations, and the correlation~     with other physiological parameters.~   "
85947|NCT02442063|"~     This phase Ib combination study is being conducted to assess the safety and tolerability of~     radium Ra 223 dichloride in combination with paclitaxel in cancer subjects with bone lesions~     with special focus on Grade 3/4 incidence of neutro- and/or thrombocytopenia and exploration~     of the mode of interaction (i.e. additive or synergistic interaction) between the selected~     chemotherapy and radium Ra 223 dichloride with regard to myelosuppression.~   "
85985|NCT02441556|"~     This trial will provide valuable insights into the safety and efficacy of endovascular~     treatment for acute ischemic stroke patients with basilar artery occlusion within 8 hours of~     estimated occlusion time.~   "
85948|NCT02442050|"~     The use of a modified depolarizing cardioplegia solution in adult cardiac surgery would allow~     for prolonged re-dosing intervals while providing equivalent myocardial protection. The use~     of del Nido solution has been used extensively in congenital heart surgery for over 25 years.~     The primary objective is to determine whether expanding this technique to adult cardiac~     surgery will confer significant benefits in both surgical workflow and patient clinical~     outcome. The investigators hypotheses with regard to the del Nido solution will demonstrate~     (1) a non-inferior delivery to the current blood-based cardioplegia strategy in functional~     recovery or clinical outcome, and (2) superior delivery to the current blood-based~     cardioplegia strategy in cost analyses.~   "
85949|NCT02442037|"~     Phase I-II Clinical Trial - Safety and efficacy of umbilical-cord-derived mesenchymal stem~     cell (UC-MSC) in patients with active ulcerative colitis，randomized, single blind, controlled~     prospective study.~   "
85950|NCT02442024|"~     The investigators aimed at evaluating the metabolic effects of the inversion of the typical~     Italian sequence of food ingestion at the main meals in type 2 diabetic patients.~   "
85951|NCT02442011|"~     This is a bio repository of blood specimens from subjects with different Hematological~     disorders.~   "
85952|NCT02441998|"~     Colorectal cancer is the second leading cause of cancer related death in the United States.~     Colonoscopy is the most commonly performed screening procedure and diminutive polyps (<5mm)~     are the most commonly found polyps during colonoscopy. Although these polyps have a very low~     risk of harboring malignancy, they are routinely removed to determine surveillance intervals.~      Narrow Band Imaging is equipped on widely available colonoscopes and in expert hands can~     allow accurate real-time optical histologic diagnosis of colorectal polyps. If this practice~     can be applied widely, there is significant potential for cost savings.~      This has led to a 'characterize, resect and discard' strategy where polyps determined to be~     hyperplastic (benign with no neoplastic potential) can be left in place and those determined~     to be adenomatous (have neoplastic potential) can be resected and discarded.~      It is unclear if endoscopists without prior expertise or training in Narrow Band Imaging can~     achieve adequate diagnostic accuracy to put 'characterize, resect and discard' into wide~     practice.~   "
85953|NCT02441985|"~     Primary orthostatic tremor(POT) is a rare progressive functionally disabling tremor disorder.~     The characteristic features of POT are symptoms of unsteadiness in legs reported by patients~     when they are standing and improvement of symptoms upon walking and sitting. Due to the~     limited success of other treatment options there is a clear merit in continuing efforts to~     explore and investigate novel treatment modalities. Transcranial magnetic stimulation (TMS)~     is a well-established physiological tool to understand brain function. When repetitious TMS~     pulses are delivered to a specific target at predefined stimulation parameters, it is~     referred to as rTMS therapy.The investigators propose a novel approach to investigate the~     clinical and physiological effects of low frequency rTMS therapy in POT. The overarching~     hypothesis of this study is that low frequency rTMS therapy delivered to the cerebellum will~     modulate the cerebellar excitability and result in clinical improvements.In order to~     determine the physiological effects related to rTMS, the tremor physiology will also be~     recorded with surface electromyography (EMG). The investigator will also record the changes~     in cerebellum excitability in response to rTMS using cerebello-cortical inhibition (CBI), a~     well-established TMS parameter.~   "
85954|NCT02441972|"~     The purpose of this study is to determine whether 18F-Al labeled RGD is safety and effective~     for cancer diagnosis and therapy response.~   "
85955|NCT02441959|"~     The purpose of this study is to compare the clinical and radiographic outcomes of full~     endoscopic lumbar discectomy versus open lumbar decompression for the treatment of lumbar~     herniated discs in which the patient's leg pain is greater than back pain.~   "
85956|NCT02441946|"~     The purpose of this study is to evaluate the biological effects of abemaciclib in combination~     with anastrozole and compare those to the effects of abemaciclib alone and anastrozole alone~     in the tumors of postmenopausal women with hormone receptor positive (HR+), human epidermal~     growth factor receptor 2 (HER2) negative breast cancer.~   "
85957|NCT02441933|"~     This is a randomized, open-label, multicenter, phase III study comparing anthracyclines~     followed by taxane to anthracyclines followed by taxane plus carboplatin as (neo)adjuvant~     therapy in patients with triple-negative breast cancer.~      Patients with stage II/III operable triple-negative breast cancer are eligible. Patients who~     need adjuvant chemotherapy after breast surgery as well as patients who need neoadjuvant~     chemotherapy for TNBC are eligible.~   "
85958|NCT02441920|"~     Periodontitis is a highly prevalent chronic inflammatory disease that is characterized by~     loss of the periodontal ligament and alveolar bone, and is a major cause of tooth loss.~     Results from clinical and epidemiological studies have suggested that periodontitis and tooth~     loss are more prevalent in individuals with rheumatoid arthritis (RA). There is evidence to~     suggest that periodontitis could indeed be a causal factor in the initiation and maintenance~     of the autoimmune inflammatory response that occurs in RA. If so, chronic periodontitis might~     represent an important modifiable risk factor for RA. However, to date longitudinal studies~     on the effect of periodontitis on disease progression in RA are lacking. The aim of the~     present study is to assess the periodontal status of patients enrolled in an established~     longitudinal cohort of RA patients. These data will then be analysed to evaluate whether or~     not periodontal inflammation is related to parameters of rheumatoid arthritis.~   "
85959|NCT02441907|"~     Diabetic macular edema refers to swelling (fluid accumulation) in the center of the retina.~     The retina is like the film of a camera and is located in the back of the eye. This condition~     can develop in diabetics where swelling results from leaking of fluid from the blood vessels~     of the eye, into the center of the retina, the macula. If left untreated, this can affect~     central vision. The current standard treatment for diabetic macular edema includes~     medications injected directly into the eye (intravitreal injections) and laser eye treatment.~     The drugs that are injected directly into the eye are known as anti-Vascular Endothelial~     Growth Factor (anti-VEGF) agents which help to reduce the leaking. However, response in~     patients to these anti-VEGF drugs can vary and examination of predictive factors is required.~     This particular study examines cellular factors called cytokines in patients receiving~     aflibercept, a type of anti-VEGF drug, in the hopes of detecting changes in cytokines that~     can predict treatment response amongst groups of patients.~   "
85960|NCT02441894|"~     Primary Objective:~      To assess the tolerability of cabazitaxel 25 mg per body surface area (m^2) with primary~     prophylactic polyethylene glycol-granulocyte-colony stimulating factor (PEG-G-CSF) in terms~     of the incidence rate of febrile neutropenia (FN) (defined: absolute neutrophil count [ANC]~     <1000 per volume [mm^3] and a single temperature of >38.3 degree or a sustained temperature~     of ≥38 degree Celsius for more than one hour) during Cycle 1.~      Secondary Objective:~      To assess overall rate of FN and grade ≥3 neutropenia and diarrhea; frequencies of dose delay~     due to adverse events (AEs); dose reduction due to AEs; relative dose intensity; incidences~     of FN-related hospitalization and use of intravenous (IV) anti-infectives; tolerability~     according to National Cancer Institute Common Terminology Criteria for Adverse Events~     (NCI-CTCAE) v4.0; prostate specific antigen (PSA) response (50% decrease); tumor response~     according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 if available.~   "
85961|NCT02441881|"~     A double blind randomised controlled trial of radiofrequency thermal ablation treatments of~     great saphenous varicose veins: Venefit (Closurefast), vs. Radiofrequency induced Thermal~     Therapy vs. Endovenous Radiofrequency.~      Assessments by visual pain scores, duplex ablation and quality of life questionaires~   "
85962|NCT02441868|"~     This study is a pilot test of an intervention to train family caregivers of home hospice~     patients about recognizing and treating shortness of breath.~   "
85963|NCT02441855|"~     Despite the efficacy of modern treatment, community-acquired pneumonia (CAP) is the the~     leading cause of death. Prognostic scores have been developed to estimate the risk of adverse~     outcome. Several serum biomarkers have been also investigated in patients with CAP. A growing~     number of echocardiographic markers have been evaluated as possible predictors of prognosis~     in patients with pulmonary and infectious diseases such as sepsis, septic shock, human~     immunodeficiency virus infection, pulmonary tuberculosis, and chronic obstructive pulmonary~     disease. As echocardiography is a non-invasive, reliable, cost-effective, and reproducible~     diagnostic tool to evaluate cardiac function and structures, the investigators aimed to~     investigate left and right ventricular functions and aortic elastic properties in CAP~     patients. Furthermore, the investigators also aimed to observe relationships between~     echocardiographic findings and inflammatory and cardiac serum biomarkers in patients with~     CAP.~   "
85964|NCT02441842|"~     Perioperative hypertension is commonly associated with surgical craniotomy. As the~     sympathetic nervous system and the renin-angiotensin-aldosterone system play a key role in~     the development of this hypertension, preoperative single dose therapy with a -adrenergic~     receptor blocker or an angiotensin converting enzyme (ACE) inhibitor may be useful in~     preventing this. To assess this as well as to study potential markers of these two systems,~     the investigators will perform a randomized, double blind, placebo controlled study to~     compare the single dose effect of preoperative administration of a -receptor blocking drug~     (atenolol) and an ACE inhibitor (lisinopril) with a control group receiving a placebo tablet~     (glucose) on perioperative hypertension in craniotomy patients.~   "
85965|NCT02441829|"~     This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral~     dose of eleclazine and its metabolite, GS-623134, in participants with normal and impaired~     renal function. Participants in the healthy control group will be matched to participants~     with impaired renal function by age (± 5 years), gender, and body mass index (± 10%).~   "
85966|NCT02441816|"~     The purpose of this study is to assess a new treatment pattern for aflibercept. The aim is to~     achieve and maintain the best benefit of visual function and avoid unnecessary hospital~     visits.~      The hypothesis to be tested is whether intravitreous aflibercept given in an 8 week cycle of~     treatment in year 1 and a capped treat and extend treatment paradigm in year 2 can lead to~     improved vision and reading speed in eyes with active wet AMD over 2 years while reducing~     hospital visits.~   "
85967|NCT02441803|"~     Objectives:~      Primary Objectives:~        1. To determine the safety and feasibility of allogeneic hematopoietic stem cell~          transplantation (AHSCT) as initial salvage treatment for patients with primary induction~          failure (PIF) acute myeloid leukemia (AML).~        2. To determine efficacy of AHSCT following decitabine, clofarabine, idarubicin, and~          cytarabine (DCIA) salvage chemotherapy evaluated by overall response rate (RR), defined~          as complete response (CR) or CR without platelet recovery (CRp) or CR with insufficient~          hematological recovery (CRi).~      Secondary Objectives:~        1. To determine the percentage of patients with PIF AML eligible for AHSCT after up to 2~          courses of induction chemotherapy.~        2. To determine the early treatment-related mortality (TRM) (within first 4 weeks of first~          salvage chemotherapy regimen with DCIA and day 100 TRM after AHSCT.~        3. To determine the efficacy DCIA regimen as salvage chemotherapy for patients with PIF AML~          (% of patients who achieve </=5% bone marrow blasts prior to AHSCT.~        4. To determine the TRM at 1 year, relapse rate (RR), overall survival (OS) and event-free~          survival (EFS) for patients with PIF AML treated with DCIA followed by early AHSCT.~   "
85968|NCT02441790|"~     Fractures of the fifth metacarpal neck are the most common injury involving the upper~     extremity. Patients are typically young adult males. Restoring function quickly and reliably~     for return to work and/or activity is important; these patients are a significant labour~     force demographic. Treatment is historically splinting for approximately 3-4 weeks. Splinting~     a fracture is a trade-off. Immobilization allows stabilization and fracture healing, but~     also causes hand stiffness and weakness leading to impaired function. Little prospective~     research exists; there is no agreement for ideal duration of splinting or therapy,~     demonstrating clinical equipoise. A new concept in hand rehabilitation is early active range~     of motion (EAROM). The objective of this trial is to establish if EAROM provides improved~     early (6 week) hand function when compared to standard immobilization.~   "
85969|NCT02441777|"~     The aim of this pilot study is to assess the ability of a new polarization sensitive optical~     coherence tomography system to obtain high-quality images of retinal birefringence.~   "
85970|NCT02441764|"~     This is a PMS to observe the safety profile of Halaven in normal clinical practice setting.~   "
85971|NCT02441751|"~     QT interval changes is measured during all phases of the operation. The protocol is focusing~     at intraoperative bleeding events and is also observing QT interval changes during anesthetic~     and operative procedures.~   "
85972|NCT02441738|"~     Atrial fibrillation (AF) is the most common cardiac arrhythmia with a lifetime risk of~     developing AF of 1 in 4 people aged over 40. Besides hemodynamic compromises stroke remains~     the most feared complication of AF with an increase in risk by 5-fold.~      Catheter ablation has evolved as a standardized treatment option in paroxysmal AF. Due to the~     advanced electrical and structural remodeling the single procedural results of catheter~     ablation for persistent and longstanding persistent AF are rather disappointing without a~     proven superiority of any applied strategy compared to others. However, repeated catheter~     ablation can achieve better results. The surgical (epicardial) approach seems to be more~     effective, though still a significant amount of failures exist. Checking the epicardial~     ablation lines and if necessary making additional endocardial lines (which is a hybrid~     ablation) is expected to be most efficacious in avoiding lesion gaps and providing the most~     complete lesion set.~      The study objective of this pilot trial is to compare the safety and efficacy of catheter~     ablation within 6 months versus a hybrid ablation consisting of endoscopic epicardial surgery~     combined with endocardial catheter ablation (performed one-stage) in preventing the~     recurrence of atrial fibrillation (AF) in symptomatic, drug refractory patients with~     persistent or longstanding persistent atrial fibrillation.~   "
85973|NCT02441725|"~     This is a study to provide an in-depth validation of the 1-minute sit-to-stand test as a~     measure of exercise capacity in patients with chronic obstructive pulmonary disease (COPD).~     Patients will perform the 1-minute sit-to-stand test and other validated exercise tests and~     questionnaires.~   "
85974|NCT02441712|"~     This is a Randomized Controlled Trial (RCT) regarding the conservative treatment of~     patellofemoral pain (PFP) with an impairment based rehabilitation program. Those with PFP can~     have a variety of impairments, such as knee and hip muscle weakness, poor movement patterns,~     weak core activation and muscle tightness. Several recent RCT trials have looked at treating~     single impairments, but to date no RCT have address individualized patient impairments during~     a rehabilitation program. Abnormal muscle firing patterns have also been identified during~     functional tasks; such as jogging, stair climbing, and performing a single leg squat.~     Conflicting studies have produced changes to the quadriceps and hip muscle firing patterns~     with those with PFP. The abnormal activation patterns has been suggested to be why~     strengthening programs alone do not improve movement patterns during functional tasks for~     those with PFP. Patterned electrical neuromuscular stimulation (PENS) is a novel form of~     electrical stimulation that replicates proper firing patterns based off healthy~     electromyography patterns. The purpose of the study is to investigate the benefits of PENS~     with a impairment based rehabilitation program for the treatment of PFP. The rationale for~     this investigation is to assess the benefits of PENS with therapeutic exercise at improving~     altered firing patterns of the lower extremity muscles during functional tasks.~   "
85975|NCT02441699|"~     This is a matched-cohort study designed to assess the health impact of a rural demand-driven~     water and sanitation intervention that provides piped treated water and household level~     pour-flush latrines and bathing rooms, as implemented by Gram Vikas.~   "
85976|NCT02441686|"~     This research study is evaluating a combination of three drugs called lenalidomide,~     subcutaneous (injection under the skin) bortezomib, and dexamethasone (RVD) as a possible~     treatment for multiple myeloma.~   "
85977|NCT02441673|"~     Post Anaesthetic Shivering is a common complication of Subarachnoid block. It is graded based~     on it's severity and has been known to cause various problems like patient's discomfort,~     hypoxia, change in hemodynamic variables of the patient and poor wound healing. This problem~     has been managed via pharmacologic and non-pharmacologic means. Non-pharmacologic modalities~     involve options aimed at warming the patient. Pharmacologically, opioids are used more~     commonly to prevent and treat this condition. This then introduces the side effect of~     nausea/vomiting and sedation which may reduce overall patient's satisfaction on the~     perception of the Subarachnoid block. It is for this reason that Nefopam - a centrally acting~     non-opioid, non-steroidal anti-inflammatory drug (NSAID) analgesic, relatively new drug in~     the Nigerian market with significant anti-shivering effect is compared with a well~     established opioid like Tramadol. Having similar cost profile, the option of replacing~     Tramadol with Nefopam especially in conditions where the patient is more hemodynamically~     unstable is considered in this project.~   "
85978|NCT02441660|"~     A prospective case control study to determine the effectiveness and longevity of 8% capsaicin~     patch in treating neuropathic pain in persons with spinal cord injury. The investigators will~     study spinal cord injury patients at South Texas Veterans Health Care Systems Spinal Cord~     Injury inpatient unit and outpatient clinics.~   "
85979|NCT02441647|"~     The purpose of this study is to check the safety under normal conditions of use through the~     emergence of signs of irritability and sensitization of the genital mucosa.~   "
85980|NCT02441621|"~     The ability of the global end-diastolic volume index (GEDVI), stroke volume variation (SVV)~     and pulse pressure variation (PPV) for prediction of fluid responsiveness in presence of left~     ventricular diastolic dysfunction is still unknown. The aim of the present study was to~     challenge the predictive power of GEDVI, SVV and PPV in cardiac surgery patients undergoing~     aortic valve replacement.~   "
85981|NCT02441608|"~     The purpose of this study is to prove the product tested does not cause photoirritation or~     photosensitization reactions when exposed to sun light.~   "
85982|NCT02441595|"~     The purpose of this study is to explore if an intervention using Mindfulness Based Childbirth~     and Parenting education (MBCP) targeted to stressed pregnant women is effective in: 1)~     reducing prenatal stress, 2) preventing perinatal maternal mental ill-health, 3) preparing~     the mother for labor and 4) promoting positive infant-caregiver attachment.~   "
85983|NCT02441582|"~     This study aims to determine whether prehospital 12 lead ECG telemetry decreases the time to~     reperfusion in patients presenting with STEMI. A randomised controlled trial will be~     conducted in Gauteng and the Western Cape among 100 adult patients (>18 years) presenting~     with ST-elevation myocardial infarction according to a specific inclusion and exclusion~     criteria outlined in the full protocol. Consenting patients will be randomly assigned to have~     their prehospital ECG sent to the receiving cardiac facility or not. The onset-to-reperfusion~     and door-to-reperfusion times will be recorded and compared between the two groups by using~     the Fisher's exact test and a simple unpaired Student's t-test. Data will also be subjected~     to multivariate analysis of variance to test for statistical significance within a variety of~     factors that may influence reperfusion times.~   "
85987|NCT02441530|"~     Vitamin D in the treatment of primary dysmenorrhoea. Design:Randomised controlled trial.~     Setting:In a university hospital. Population: 142 women aged 16-35 years. Methods: Patients~     were treated with 667 unit of vitamin D once a day, 200 unit of vitamin E once a day or 400~     mg ibuprofen twice a day,2 days before the date of menstruation and continued through the~     first 3 days, for 2 months. Main outcome measures: Pain score. Results: Mean VAS of vitamin D~     group was 4,91, was 6,54 in the vitamin E group and was 4,02 in the ibuprofen group~     Conclusion:Vitamin D and vitamin E are effective in relieving the pain,but the effect of~     vitamin D are more prominent~   "
85988|NCT02441517|"~     The purpose of the study was to understand if there is benefit in treatment with a medicine~     called enzalutamide in the re-treatment setting. Patients must have been previously treated~     with enzalutamide in the pre-chemotherapy setting for a minimum of 8 months and have disease~     progressed, followed by docetaxel and/or cabazitaxel for at least 4 cycles.~   "
85989|NCT02441504|"~     Background: The aim of the present study was to evaluate the changes in the microvascular~     density and reactivity in patients with type 1 diabetes (T1D) resulting from low intensity~     chronic exercise training.~      Methods: This study included 22 (34 ± 7 years) consecutive outpatients with T1D and disease~     duration > six years. We used intravital video-microscopy to measure the basal skin capillary~     density as well as capillary recruitment using post-occlusive reactive hyperemia (PORH) in~     the dorsum of the fingers. Endothelium-dependent and -independent vasodilation of the skin~     microcirculation was evaluated in the forearm with a laser Doppler perfusion monitoring~     (LDPM) system in combination with acetylcholine and sodium nitroprusside iontophoresis, PORH~     and local thermal hyperemia.~   "
85990|NCT02441491|"~     ROHHAD (rapid onset obesity, hypothalamic dysfunction, hypoventilation, and autonomic~     dysregulation) syndrome is a rare pediatric disorder associated with a cancer called~     neuroblastoma and presumed to be driven by an attack of the immune system on specific area in~     the brain. Patients develop severe symptoms and often succumb to this disease. Based on the~     researchers' experience the investigators conduct a clinical trial to study intensive~     immunosuppression with high-dose cyclophosphamide in these patients. In addition to~     describing the symptomatic improvement, the investigators' trial seeks to define objective~     markers of disease activity.~   "
85991|NCT02441478|"~     Epilepsy is a frequent neurological disorder with about a third of patients having seizures~     despite treatment. At least some of these seizures can be linked to a low compliance and~     therapy adherence of patients. Compliance is defined as the extent to which a person's~     behavior (in terms of taking medication, following diets, or executing life style changes)~     coincides with medical or health advice. Therapy adherence of patients suffering from~     epilepsy is low with reported rates between 30 and 50%, although adherence to anticonvulsive~     drug therapy is critical for effective disease management and low therapy adherence is~     associated to higher mortality in epilepsy. The reasons for low therapy adherence are still a~     matter of research. Some known factors influencing compliance in epilepsy are related to its~     chronic nature, but others seem to lie in a complex interaction between psychiatric~     comorbidity and an impairment of neural systems underlying behavior. Furthermore, therapy~     adherence rests a variable difficult to measure, especially in epileptic patients where~     classical tools such as questionnaires and electronic monitoring devices have been shown to~     be imprecise. It has been argued that the term 'compliance' should be replaced by~     'co-operative behavior' and non-compliance can therefore be interpreted as troubled~     co-operative behavior. This behavioral approach offers the potential of using tools and~     methods of the latest developments in behavioral neuroscience. Neuroeconomics, a scientific~     field on the border of psychology, economics and neuroscience, has used economic game~     paradigms in order to operationalize cooperative behavior and to identify several brain areas~     by functional brain imaging that have been linked to social co-operative behavior. The~     majority of these brain areas are located in the frontal cortex [ventromedial~     frontal/orbitofrontal cortex, and rostral anterior cingulate cortex. Epilepsies originating~     in the frontal lobe are subsumed under the term frontal lobe epilepsy (FLE) and represent~     20-30% of all partial seizures and 25% of all refractory focal epilepsies referred to~     epilepsy surgery.~      The investigator's project plans to study compliance and cooperative behavior of patients~     suffering from frontal lobe epilepsies through a neuroeconomic approach by (1) comparing the~     behavior of these patients in the prisoners' dilemma game to the behavior of age-, gender-,~     and education-matched healthy controls, (2) correlation of game behavior to brain activation~     measured by functional magnetic resonance imaging in both patients and healthy controls and~     (3) studying the link between cooperative behavior to compliance captured by pill counts and~     questionnaires.~   "
85992|NCT02441465|"~     The purpose of this study is to characterize the pharmacokinetics (PK) of a single~     intravenous (IV) infusion of 14C-labeled vemurafenib administered shortly after an oral dose~     of vemurafenib and following multiple oral doses of vemurafenib twice daily (BID) at steady~     state as well as to estimate the absolute bioavailability of multiple oral doses of~     vemurafenib BID at steady state in participants with BRAF^V600 mutation-positive~     malignancies. The study has two periods: Period A and Period B. During Period A, participants~     will receive vemurafenib BID orally from Day 1 to Day 20 and during Period B, participants~     will receive single IV infusion of 14C-labeled vemurafenib along with vemurafenib BID oral~     dose.~   "
85993|NCT02441452|"~     The aim of this study was to compare the functional capacity of exercise by six-minute walk~     test and lung function by spirometry, before and after Nuss procedure in subjects who have~     undergone the early rehabiliation program with those who were under conventional care.~     Researchers want to find out if early rehabilitation is a strategy to enhance recovery after~     Nuss procedure.~   "
85994|NCT02441439|"~     This study is aimed to compare the efficacy of 2 doses of iron sucrose given intravenously -~     200 mg versus 500 mg.~   "
85995|NCT02441426|"~     Malnutrition is considered one of the most prevalent risk factors for morbidity and mortality~     in children under five. An estimated 20% of children in the developing world are malnourished~     [1] and poor nutrition is linked to more than half of all child deaths worldwide [2].~     Malnutrition in early childhood may lead to cognitive and physical deficits and may cause~     similar deficits in future generations as malnourished mothers give birth to low birth weight~     children [3]. In addition, malnutrition increases susceptibility and incidence of infections~     and is associated with diminished response to vaccines.~      The MAL-ED Project is designed to determine the impact of enteric infections/diarrhea that~     alter gut function and impair children's nutrition, growth and development to help develop~     new intervention strategies that can break the vicious enteric infection-malnutrition cycle~     and reduce its global burden.~      The overall objective of the MAL-ED Project is to quantify the associations of specific~     enteric pathogens, measures of physical and mental development, micronutrient malnutrition,~     gut function biomarkers, the gut microbiome, and immune responses in very young children in~     resource-limited settings across eight sites that vary by culture, economics, geography, and~     climate.~      The central hypothesis of the MAL-ED Project is that infection (and co-infection) with~     specific enteropathogens leads to impaired growth and development and to diminished immune~     response to orally administered vaccines by causing intestinal inflammation and/or by~     altering intestinal barrier and absorptive function. Data analyses will test for associations~     between enteropathogen infections and growth/development to help illuminate:~        -  which micro-organisms or mixed infections are most frequently associated with growth~          faltering and poor development; and~        -  at what age specific infections cause the most disruption to growth and development and~          impair immune response.~   "
85996|NCT02441413|"~     The objective of this study is to detect Bronchiolitis Obliterans Syndrome (BOS) in an early~     stage using the outcome parameters generated by Functional Respiratory Imaging (FRI). Robust~     and automated segmentation algorithms will be developed for these parameters, focusing on~     quantitative computed tomography (CT) image analyses to provide the physician a more~     sensitive diagnostics tool. The evolution of BOS over time will be monitored using nmon-rigid~     image registration methods.~   "
85998|NCT02441387|"~     Predictors of response to pharmacological treatment of major depressive disorder will be~     investigated. One hundred and twenty patients will be included in a naturalistic clinical~     trial. Psychopathology, personality traits, cognitive performance, brain structural changes~     and genetic polymorphisms will be evaluated. Patients will be followed for 18 months with a~     pharmacological treatment algorithm and will be evaluated monthly until 6th month and every 3~     months, up to 18 months. Psychoeducation will be offered to patients who did not remit until~     3 months of pharmacological tretment.~   "
85999|NCT02441374|"~     There are some treatments after Stroke. Among these, use forced therapy (FUT), which is based~     on overcoming learned disuse by reintroduction of the paretic upper limb in the performance~     of daily activities. There are different protocols FUT to the daily time constraint, the~     number of days and even the type of constriction. Researchers have developed a protocol using~     four weeks constriction, daily constriction 24 hours and with the free end of the weekends.~     Because it is a restrictive therapy, which requires the use of one of the arms and on the~     other hand, this mode of treatment is open to criticism, however, despite the efficacy of the~     protocol, patients do not have good adhesion to the protocol for the constriction severe over~     time. The objective of this work is to verify the safety of the developed protocol and~     analyze the feasibility of reducing the daily time of constriction 12 hours, with a new~     protocol movement constriction, easier to perform and more patient acceptance. Participate in~     this study 82 individuals hemiparetic post Stroke, which will be recruited to Neurovascular~     Diseases Clinic and will be registered at the Rehabilitation Center of Integrated State~     Hospital. Participants will be randomly divided into three groups: the FUT24 (non-paretic~     upper limb constriction 24 hours a day, five days a week for 4 weeks), the FUT 12~     (non-paretic upper limb constriction for 12 hours a day, five days a week for 4 weeks) and CK~     (Classic Kinesiotherapy, at least 2 times a week for 4 weeks). Will be held weekly and after~     the end of the monthly monitoring reviews protocols. For the rating scales are use: National~     Institute of Health Stroke Scale, the Ashworth Scale, the Wolf Motor Function Test, the Motor~     Activity Log, Fugl-Meyer Assesment, dynamometry handgrip and surface electromyography (flexor~     and extensor muscles wrist). The researchers hope that this protocol does not bring damage to~     the upper limb in constriction and it is established a new protocol FUT easier to perform and~     more acceptable to patients, allowing the use of this technique by health professionals.~   "
86000|NCT02441361|"~     Bariatric surgery may attenuate insulin resistance and low-grade inflammation in obese~     subjects. This trial aims to test whether exercise training can add to the benefits of~     bariatric surgery on insulin sensitivity and inflammation. In addition, this study aims to~     investigate whether exercise training can counteract bone loss induced by bariatric surgery.~   "
86001|NCT02441348|"~     Voice therapy is the standard-of-care for many of the nearly 140 million people in the United~     States who suffer from voice disorders,1 yet patients claim that current therapies are~     ineffective at meeting their voice needs.2 Published data by our research team indicate that~     patients think that transfer of target voice techniques to every day voice use (i.e.~     conversation) is the most difficult aspect of therapy,2 and that training techniques in~     conversation is the most useful aspect of voice therapy.2 Unfortunately, traditional voice~     therapy programs spend little, if any, time training voice techniques in conversation.3 This~     lack of functional specificity in voice therapy may contribute to the estimated 65% attrition~     rate.4 Even after some form of treatment, patients are still struggling with daily~     conversational voice use, and voice disorders continue to cause serious disability, stress~     and depression, which negatively affects social functioning and job performance.5 A new voice~     therapy program, Conversation Training Therapy (CTT), based on published patient reports on~     dissatisfaction with traditional therapy, was developed by the Investigators. It was honed~     with recommendations from expert clinical voice-specialized speech-language pathologists, and~     successfully piloted in a small case series of patients with voice problems. The~     investigators objective in this application is to test CTT in the rehabilitation of patients~     with voice disorders. The investigators hypothesize that, as demonstrated in the~     investigators preliminary case studies, these methods will result in early treatment success,~     and reduce the time required to reach therapeutic goals, thereby reducing costs associated~     with voice treatment.~   "
86002|NCT02441335|"~     The goal of this study is to examine how cellular dysfunction can lead to preterm birth.~     Women with singleton pregnancies with spontaneous preterm labor, preterm premature rupture of~     membranes, and cervical insufficiency (20 to 36-6/7 weeks gestation), and term deliveries~     (greater than 38 weeks) will be enrolled. Medical/obstetric history and pregnancy outcomes~     will be recorded. Maternal blood, urine and cervical cells (enrollment); cord blood and~     placental biopsy (delivery) will be collected.~   "
86003|NCT02441322|"~     This study is to assess the utility of high resolution 3D echo planar magnetic resonance~     spectroscopy (3D EPSI) in monitoring Novo-TTF response in glioblastoma multiforme (GBM)~     patients.~   "
86004|NCT02441309|"~     This is a Bayesian designed multi-arm, multi-centre, open label phase II study. The target~     sample size of 40 patients will be recruited from up to 8 EU countries, but this may be~     revised in light of the interim analysis. Patients with relapsed or metastatic osteosarcoma~     will be divided into three treatment groups. They will all either have surgery or a biopsy~     before and after six weeks exposure to either Mifamurtide alone, Ifosfamide alone, or~     Mifamurtide combined with Ifosfamide. They will then receive further treatment to a maximum~     of 42 or 36 weeks in total (depending on Arm), with all patients being able to receive 36~     weeks of Mifamurtide treatment.~   "
86005|NCT02441296|"~     The optimal choice of carbohydrate in infant formula needs to be assessed in more detail.~     Lactose has conventionally been used in most milk-based infant formulas, but more recently~     lactose-free formulas based on corn syrup solids/maltodextrins have gained in popularity.~     However, the metabolic consequences have not been examined.~      In a pilot study, the investigators will assess the postprandial metabolic response to a meal~     of formula with either lactose or maltodextrins. A breastfed reference group is also~     included.~   "
86006|NCT02441283|"~     This is a rollover study to assess resistance and durability of response to ABT-493 and/or~     ABT-530 in subjects who have participated in Phase 2 or 3 clinical studies with these agents~     for the treatment of chronic HCV.~   "
86020|NCT02441101|"~     This clinical study has been designed to test whether a new pacing therapy would lead to~     improvement in heart function, symptoms and quality of life in a specific group of heart~     failure patients. This group has a unique electrical conduction problem (Right Bundle Branch~     Block) that did not respond well to the current available pacing therapy.~   "
86021|NCT02441088|"~     Participants in this research study have tumors that express somatostatin receptors such as~     neuroendocrine tumors, medulloblastoma, meningioma, and neuroblastoma.~      Approximately 64 people will participate in this study conducted at the University of Iowa.~   "
86228|NCT02438384|"~     This is a three arm pilot randomized trial. Patients will be assigned to:~        1. Usual care~        2. Video education in the ED~        3. Video education in the ED plus phone follow-up at three days with geriatric pain~          management specialist for all patients with pain >=4/10~   "
86007|NCT02441270|"~     In metastasized of locally advanced breast cancer patients, local problems often occur like~     skin metastases, ulcerations or lymph node metastases. These problems are related to a worse~     quality of life, while overall survival is generally in the order of months to years.~     Treatment of these lesions is challenging, especially after failure of first or second line~     systemic therapy. Local treatments, like radiation, are able to give short-term palliation,~     but the effect is often disappointing in the long run. Therefore, the search for new~     therapeutic strategies like the combination of local and systemic treatments is emerging.~      Recent investigations clearly show that radiation is capable of inducing a systemic~     anti-tumor response. Both in mouse models and in patients, it was reported that irradiating~     one metastasis can slow down the growth of other non-irradiated metastases. This effect is~     called the abscopal effect and is immune-mediated. There are also several chemotherapeutics~     that are capable of influencing the immune response like cyclophosphamide. Cyclophosphamide~     is a known inducer of immunogenic cell death, which leads to the activation of dendritic~     cells and thus the presentation of antigens.~      In this pilot study the investigators wish to identify the immunological effects of combined~     treatment with radiation and cyclophosphamide in breast cancer patients. Five patients with~     metastasized breast carcinoma will be treated with the combined treatment and the~     immunological effects will be monitored using repeat blood draws and biopsies. These effects~     will be correlated to the clinical response.~   "
86008|NCT02441257|"~     Laryngeal mask airway is seldom used for control ventilation in America, while it is popular~     in China. The question is whether the incidence of gastroesophageal reflux in control~     ventilation is really higher than in spontaneous ventilation. So the investigators combine~     the third generation laryngeal mask and catheter-based Digitrapper ph-Z monitor system to~     evaluate the exact incidence of gastroesophageal reflux in these two groups.~   "
86009|NCT02441244|"~     Modern antiretroviral therapy (ART) has transformed the clinical care and lived experience of~     HIV infection. However, increased rates of adverse health conditions that are related to~     immune activation, such as cardiovascular disease (CVD) and neurodegenerative disease in~     ART-treated individuals persist. An important cause of this inflammation is the gut CD4 T~     cell loss and the leaking or translocation of luminal gut bacteria and other microbes~     across the bowel wall and into the bloodstream.~      The use of complementary and alternative therapies is common among people living with HIV,~     however their efficacy has generally not been well demonstrated. Probiotics are live microbes~     that may provide a health benefit to the host and the investigators believe that the~     simultaneous use of probiotics along with antiretroviral therapy (ART) will improve gut CD4 T~     cell restoration and function and therefore reduce microbial translocation and immune~     activation.~      Probiotic Visbiome consists of a high potency blend of eight different probiotics. The~     precise mechanism of action of Visbiome is unknown, but preclinical studies have shown that~     Visbiome may modulate the immune response towards a phenotype that is associated with reduce~     inflammation, and Visbiome was also protective in a non-human primate model of SIV infection.~     Therefore, we believe that the beneficial bacteria from Visbiome will accelerate the~     normalization of gut immune cells and function in HIV-infected individuals as they start ART.~     Early resolution of gut immune cells may normalize microbial translocation and immune~     activation and will reduce the rates of HIV-associated comorbidities.~   "
86010|NCT02441231|"~     Modern antiretroviral therapy (ART) has transformed the clinical care and lived experience of~     HIV infection. However, increased rates of adverse health conditions that are related to~     immune activation, such as cardiovascular disease (CVD) and neurodegenerative disease in~     ART-treated individuals persist. An important cause of this inflammation is the gut CD4 T~     cell loss and the leaking or translocation of luminal gut bacteria and other microbes~     across the bowel wall and into the bloodstream.~      The use of complementary and alternative therapies is very common among people living with~     HIV, with estimates ranging from 16-60%. However, their efficacy has generally not been well~     demonstrated. Probiotics are live microbes that may provide a health benefit to the host and~     the investigators believe that the simultaneous use of probiotics along with ART will improve~     gut CD4 T cell restoration and function and therefore reduce microbial translocation and~     immune activation.~      A major challenge to HIV treatment is the suboptimal CD4 T cell count despite successful HIV~     suppression on ART in immunologic non-responders (INRs). These individuals are at increased~     risk of AIDS-related deaths and non-AIDS related comorbidities that may be associated with~     increased immune activation and microbial translocation from the gut mucosa. With limited~     treatment options, alternative therapies to reduce inflammation and restore gut immunology~     will be important. Probiotic Visbiome consists of a high potency blend of eight different~     probiotics. The precise mechanism of action of Visbiome is unknown,but preclinical studies~     have shown that Visbiome may modulate the immune response towards an immunoregualtory~     phenotype with increased the levels of IL-10 and reduced levels of proinflammatory cytokines~     (TNFα, IL1β and IL-8). Therefore,the investigators believe that the beneficial bacteria~     from Visbiome will accelerate the normalization of gut immune cells and function in~     HIV-infected INRs. It is hypothesized consumption of Visbiome for 48 weeks will help restore~     the immune system in INRs who have suboptimal immune reconstitution to currently available~     ART. Resolution of gut immune cells will mean that microbial translocation and immune~     activation will be normalized and will reduce the rates of HIV-associated comorbidities.~   "
86011|NCT02441218|"~     The primary objective of this study is to demonstrate the superiority of ivabradine over~     placebo in the reduction of cardiovascular mortality or hospitalisation for worsening heart~     failure in patients with moderate to severe symptoms of chronic heart failure, a reduced left~     ventricular ejection fraction and currently receiving recommended therapy for this disease.~   "
86022|NCT02441075|"~     This is for a study for patients that will be undergoing hematopoietic stem cell transplant~     (HSCT). For HSCT, patients will need a double lumen central venous line (CVL). One of the~     most common complications after an HSCT is Graft Versus Host Disease (GVHD).Tacrolimus or~     Cyclosporine along with methotrexate are used together in order to prevent GVHD. Normally~     these medications are given via the white lumen and blood is drawn via the unexposed red~     lumen to check the blood level of these medications. If these drugs are accidentally given~     via the wrong lumen (line) it could cause blood levels to be falsely high. This error could~     lead to the patient having to have peripheral blood draws that cause pain. The investigators~     are proposing adding an ethanol lock to your lumens (lines) to see if this would help clean~     the lines therefore preventing errors in blood tests and blood draws. An ethanol lock is a~     70% alcohol which is injected into the CVL lumen and stays within the CVL as the CVL is~     capped.~   "
86023|NCT02441062|"~     Participants in this study have been diagnosed with a tumor such as a carcinoid,~     neuroendocrine tumor, neuroblastoma, Ewing's sarcoma, or brain tumor that has cells which~     carry somatostatin receptors.~      The purpose of this research study is to see if the tumor can be identified using a special~     procedure called a positron emission tomography (PET) scan and how the results of this~     imaging procedure will change the management of the tumor.~   "
86012|NCT02441205|"~     PURPOSE: The purpose of this study is to investigate whether High Intensity Interval Training~     (HIIT)can improve the health and wellbeing of pre-diabetic elderly adults. In particular,~     there is specific interest in describing the effects of an interval exercise program on~     inflammatory state and immune function.~      DESIGN: Subjects will be sedentary, 65 to 80 years old adults, with prediabetes as defined by~     fasting plasma glucose (100 to 125 mg/dl). Before and after a 10-12 week High Intensity~     Interval Exercise training program subjects will undergo several tests including: 1) a~     maximal treadmill test, 2) an Oral Glucose Tolerance Test, 3) muscle biopsy, 4) body~     composition, 5) several physical function tests and 6) other health related measures~     including lung function, arterial stiffness and several blood measures (e.g. liver enzymes,~     kidney function).~      DATA ANALYSES & SAFETY ISSUES: As there are no comparison groups, data analyses will consist~     of performing paired t-tests on pre and post exercise training values for each of the~     measurement variables of interest. In addition, the data will be used to provide power~     calculations for future grant proposals. High Intensity Interval Training is a very safe~     exercise modality. The regular use of vigorous intensity exercise intervals have been used~     extensively in exercise training. In fact, the exercise intervals will start at levels lower~     and will be of shorter duration than were used during the maximal exercise test. They will~     then be carefully and slowly made to be more challenging as each subject is able to safely~     tolerate.~      HYPOTHESIS: The investigators hypothesize that HIIT will result in significant improvements~     in markers of inflammation, immune system markers and other health-related risk factors.~   "
86013|NCT02441192|"~     Background. The cardiovascular and cardiorespiratory coupling (CVCRC), focusing to recognize~     the synergies of standard or modified physiology that promote healthy. The investigators aim~     to study the effects of different training modalities and detraining on CVCRC.~      Methods. 32 young males were distributed in four randomized training groups: aerobic (AT),~     resistance (RT), aerobic plus resistance (AT+RT) and control (C). They were tested before,~     after the training (6 weeks) and after the detraining (3 weeks) through a graded maximal~     test. A principal component (PC) analysis of the time series of selected cardiovascular and~     cardiorespiratory variables was performed to evaluate the CVCRC. The PC1 coefficient of~     congruence in the 3 experimental conditions (before, after training and after detraining) was~     calculated for each group.~   "
86014|NCT02441179|"~     Spinal cord injury (SCI) interrupts descending synaptic pathways from brainstem premotor~     neurons to spinal motor neurons, thereby paralyzing muscles below the neurological level. In~     recent years, considerable evidence has demonstrated that acute intermittent hypoxia (AIH)~     elicits plasticity in the spinal cord and strengthens spare synaptic pathways which is~     expressed as respiratory and somatic functional recovery in animals and humans suffering from~     incomplete SCI. The fundamental hypothesis guiding this project is that AIH-induced motor~     plasticity can be harnessed to improve walking capacity in incomplete SCI patients,~     classified as C and D categories according to International Standards for Neurological~     Classification of Spinal Cord Injury (ISNCSCI). The inclusion criteria include patients > 18~     years-old, with traumatic or non-traumatic, non-progressive incomplete SCI, onset > 6 months,~     neurological level C5-T12, with walking ability with or without assistive devices, without~     joint contractures, orthopedic injuries, osteoporosis, cutaneous lesions, cardiopulmonary~     complications and a body weight below 150 Kg. A randomized, triple-blind, placebo-controlled~     parallel design study will be done including 100% of patients fulfilling the criteria.~     Participants will receive repetitive acute intermittent hypoxia (rAIH: 15 episodes of 90~     second 9% inspired oxygen interspersed with 90-second normoxia) or repetitive continued~     normoxia (rSham: 21% inspired oxygen) combined with 45 minutes body weight-supported~     treadmill training on 5 consecutive days and then three times per week for 3 weeks. Primary~     outcome measurement will be the 10-meter walking test. Secondary outcome measurements include~     the 6-minute walking test, timed up and go test, body/weight load, modified ashworth scale~     and visual analog scale. All outcomes will be measured before beginning the protocol~     (baseline), after five days of AIH/Sham (D5), weekly up to the end of the study (W2-W4), and~     a post-study follow-up for 2 weeks (F1-F2). Aditionally, cognitive assesment before and after~     the study will be performed using the Figura compleja de Rey-Osterrieth and the Test de~     aprendizaje verbal España Complutense (TAVEC). Repetitive AIH and body weight-supported~     treadmill training may represent a novel, safe, and noninvasive potential therapy to~     partially restore walking function in incomplete sub-acute and chronic SCI patients, a~     population with limited, if any, potential for improved function.~   "
86015|NCT02441166|"~     The hypothesis of the study is that Bone Marrow Tryptase (MT) level is a diagnostic marker of~     Systemic Mastocytosis (SM). Determination of the bone marrow tryptase in Bone Marrow Aspirate~     (BMA) could be a new diagnostic criteria for systemic mastocytosis with sensitivity close to~     100% and a low false negative rate. This new test could be useful to improve the ability to~     diagnose accurately systemic mastocytosis (in particular the indolent forms). Because of its~     limited invasiveness compared to bone marrow biopsy, it could also be considered as a test~     performed before bone marrow biopsy. Only patients with high bone marrow tryptase would then~     undergo bone marrow biopsy.~      In the future and if validated by this study, bone marrow tryptase could be a useful marker~     of mast cell load and help to monitor the efficacy of treatment in systemic mastocytosis.~   "
86016|NCT02441153|"~     This pilot study will take place at Health Sciences North (HSN) in Sudbury. Patients will be~     identified and screened for inclusion into the study once referred to a general or colorectal~     surgeon for resection of their rectal cancer. This may occur before or after preoperative~     chemoradiotherapy (CRT) but randomization will take place after CRT.~   "
86017|NCT02441140|"~     This research study is studying a possible test which may help doctors diagnose women with~     ovarian cancer.~   "
86018|NCT02441127|"~     Aims: The aim of present randomized controlled clinical study was to evaluate whether the~     additional use of diode laser would facilitate the donor surgery, improve the palatal wound~     healing and reduce post-operative morbidity after the coronally advanced flap (CAF) with~     connective tissue (CTG) grafts.~      Methods: Fifty-two patients with isolated recessions were treated. The CTG resulted from the~     de-epithelialization of a free gingival graft (FGG) with blade (control group) or diode laser~     (DL) (test group). The DL was used to de-epithelialize the outer part of the FGG and~     photo-biostimulate the palatal wound area. Post-operative morbidity was evaluated by using~     Oral health related Quality of life (QoL), smile related QoL and visual analogue~     scale-discomfort (VAS). Root coverage outcomes were also evaluated 6 months after operation.~   "
86019|NCT02441114|"~     This pilot study was designed to evaluate the pharmacokinetic characteristics of fluticasone,~     salmeterol, and tiotropium after co-administration of HCP 0910 (Seretide 250 diskus) and~     HGP1011 (Spiriva capsule for inhalation) which are prescribed concomitantly for the patients~     with chronic obstructive pulmonary disease (COPD).~   "
86074|NCT02440399|"~     Cesarean deliveries are prevalent. Unlike other operations, quick recovery is required for~     the mother to nurture the newborn child and establishing an appropriate mother-child bonding.~   "
86024|NCT02441049|"~     Entre Familia was a 4-year randomized controlled trial funded by the American Cancer Society.~     The study was conducted in Imperial County, California, and involved a partnership between~     the Institute for Behavioral and Community Health at San Diego State University and Clínicas~     de Salud del Pueblo, Inc. a private, non-profit corporation providing comprehensive primary~     care services to residents throughout Imperial and Riverside Counties. The investigators~     enrolled 361 Latina mothers and one of their children aged between 7 and 13 years old; in 25%~     of families, the father was also enrolled. Participants were randomly assigned to either an~     intervention or delayed-treatment control condition. The intervention consisted of a~     community health worker (or promotora)-delivered home-based intervention to promote healthy~     eating. The promotoras used a telenovela DVD series and accompanying manual, both written and~     produced by study staff. The intervention was delivered through 11 home visits and 4 support~     telephone calls over a 4 month period. Participants in the delayed-treatment condition~     received intervention materials when evaluation assessments had been completed. Evaluation~     measures were taken at baseline, 4 months (immediate post-intervention) and 10 months~     (6-months post intervention). Participants completed a self-report interview with study staff~     at each time point. Height and weight measurements were also collected for the mothers and~     children. The primary outcomes were changes in mothers' daily fruit and vegetable intake.~     Secondary outcomes for mothers, children and fathers included changes in fat intake, sugary~     beverage intake, parenting strategies, and perceived barriers to healthy eating.~   "
86025|NCT02441036|"~     Up to 15 subjects will be enrolled and randomized. Randomized subjects will receive one~     single-side Ulthera® treatment in the pre-auricular region on the face. At each subject's~     scheduled facelift procedure, resected tissue will be obtained for analysis.~   "
86026|NCT02441023|"~     The purpose of this study is to evaluate the effectiveness of nutrition therapy in~     combination with education in diabetes using a multimedia application for improving~     indicators of metabolic control in patients with type 2 diabetes.~   "
86027|NCT02441010|"~     The purpose of this study is to use monitoring and intervention technologies in suboptimal~     health status in a general population in China and evaluate the effectiveness of these~     technologies in the improvement of suboptimal health status.~   "
86028|NCT02440997|"~     The purpose of this study is to preliminarily establish the extent to which a brief~     aromatherapy intervention incrementally improves subjective and objective indicators of~     discomfort (pain, anxiety, and heart rate variability) beyond passive relaxation in youth~     with chronic headaches. A secondary objective is to establish the safety of using~     aromatherapy as a treatment strategy in youth with chronic headache. The investigators~     hypothesize that children randomized to the aromatherapy condition will demonstrate a greater~     improvement in pain, anxiety, and objectively measured distress (heart rate variability) than~     comparable children receiving only a passive relaxation treatment (a foot bath). The~     investigators further hypothesize that the aromatherapy intervention will be safe and~     well-tolerated by study participants.~   "
86029|NCT02440984|"~     The purpose of this study is to assess and explain (at least apart) anorectal disorders of~     patients with Spina Bifida by an automatic neuropathy responsive of enteric nervous system~     and epithelial barrier dysfunctions. The investigators' aim hypothetics is that autonomic~     neuropathy of patients with Spina Bifida induce enteric nervous sytem and epithelial barrier~     dysfunctions which explain anorectal disorders of these patients. Thexpect to show a~     decreased of 5% of enteric neurons per ganglia.~   "
86030|NCT02440971|"~     Up to 60% of patients with heart failure show abnormal patterns of breathing (sleep~     disordered breathing (SDB)) at night which can increase the risk of recurrent admissions and~     have important prognostic implications. SDB is however, treatable with the use of non~     invasive breathing support devices such as the adaptive servo ventilation (ASV) device. The~     aim of the study is to observe and investigate the potential role of ASV in the management of~     heart failure.~      Patients that agree to participate in this study will be requested to use an ASV ventilator~     device (called the AutoSet CS-A) to help their SDB for approximately 6 weeks. The device is~     approximately the size of a large shoe box, which can be placed at the side of the bed, with~     tubing and a mask. At night, the mask is placed over the nose and/or mouth and it blows~     positive air pressure as determined by the device itself as it constantly monitors the~     patients breathing throughout the night. During this study, the patients breathing patterns~     will be monitored non-invasively using the ApneaLink device. A non-contact device knows as a~     SleepMinder will sit on the patients bedside locker as another form of monitoring of their~     sleep patterns. Study staff will monitor the patient and give them frequent support, and they~     will also be asked questions regarding their experiences with this equipment and any symptoms~     they may have over this time. They will be followed up regarding this study at the same time~     as their follow-up requirements for their heart failure. This study will be conducted in~     total over 3 months.~   "
86031|NCT02440958|"~     Pancreatic ductal adenocarcinoma is the fourth cause of death in the Western world. Surgery~     remains the only treatment offering an advantage in terms of overall survival (5-year~     survival range, 15-25%), but unfortunately only 10-20% of patients present resectable disease~     at the time of diagnosis. Since the approval of gemcitabine as a standard treatment for~     advanced pancreatic patients, no drug or combination of drugs has significantly improved the~     prognosis. Recently, as compared with gemcitabine, FOLFIRINOX was associated with a survival~     advantage (11.1 vs 6.8 months), but had increased toxicity. In some retrospective studies,~     modified FOLFIRINOX regimen (60/120 mg/m2 of oxaliplatin and irinotecan) has an improved~     safety profile in digestive malignancies. The purpose of this phase II multicenter study was~     to investigate the efficacy and safety in patients with pancreatic cancer who progressed in~     gemcitabine-based first line chemotherapy.~   "
86075|NCT02440386|"~     The iLink Study examines whether a Conditional Economic Incentive (CEI) may be an effective~     tool for improving linkage to HIV treatment and care following referral for antiretroviral~     therapy (ART) services from a mobile health clinic in Cape Town, South Africa. The study~     examines the feasibility and acceptability of using a R300 (approximately $25 as of April~     2015) voucher - that is exchanged for cash upon initiation of ART within 3 months - to~     increase the uptake of ART among men and women living in low-income areas. This pilot study~     (n=64) includes a randomised control trial, follow-up telephone calls and medical record~     reviews, and in-depth interviews.~   "
86032|NCT02440945|"~     It is about an interventional study.The use of the blotting paper called Dried Blood Spot~     or DBS is a method of systematic neonatal screening of the metabolic diseases. Indeed, it has~     multiple interests: realized thanks to lancets, it is much less invasive than a classic blood~     collection. Besides, the transport of the blood sampling is facilitated because most of the~     analysts are stable on DBS at room temperature one week or more. Finally the use of this DM~     reduces the infectious risks bound to the manipulation of the blood sampling and to the~     inactivation of microorganisms. The moderate results are vitamin D, albumin, prealbumin, CRP,~     orosomucoide~      The DBS presents a major interest for the care of the old and fragile people who have on one~     hand a low peripheral venous capital and on the other hand for whom the possibility of a~     dosage on DBS will allow a facilitated biological follow-up. Indeed it is very important to~     detect as soon as possible the most fragile old people, those who have the biggest risk of~     seeing their health degrading during a physical, psychic or social stress, to concentrate the~     efforts of coverage and limit these risks. The advantage of the biological criteria is the~     speed of the test making (a blood test), in the absence of necessity of active participation~     by the patient (the clinical criteria require to test the patient in the walking, to test its~     muscular strength, etc.) and in the saving of time diagnosis for the clinician. The blood~     biological markers of the fragility are essentially the rate of 25OH vitamin D, the markers~     of undernutrition (albumin, prealbumin) and of the inflammation (CRP, orosomucoïde). These~     last four parameters are now measurable from the DBS thanks to the quantitative mass~     spectrometry.~   "
86033|NCT02440932|"~     Low-phenylalanine diets are commonly prescribed to people with phenylketonuria (PKU), an~     inborn disease which causes accumulation of amino acid phenylalanine (Phe) in the blood. High~     blood Phe levels can cause mental, behavioural, neurological, and physical problems. Thus,~     low-phenylalanine diets help patients to manage their condition but it is not clear whether~     they have an impact on appetite, energy intake and changes in body weight. This is important~     to explore as prevalence of obesity in this population is rising high. This study aims to~     find out the effect of PKU-type meals on appetite, appetite biomarkers, and post-meal energy~     expenditure. The investigators will recruit 26 healthy adults and ask them to participate in~     two experimental trials. On one occasion the participants will be asked to consume a~     PKU-supplemented drink followed by a PKU type-lunch and on another occasion the supplement~     and lunch will be based on normally consumed foods. Series of blood samples will be taken and~     appetite will be assessed during both experiments. Both experimental trials will finish with~     consuming an all-you-can-eat buffet.~   "
86034|NCT02440919|"~     This is a double crossover study where all patients are randomly allocated to one of two~     treatment sequences associated with endotracheal aspiration.The first treatment (A) uses two~     suctioning methods for each patient: one involving hyperoxygenation with administration of~     100% oxygen 1 minute before and after suction (intervention I), and the other~     hyperoxygenation with oxygen supply to 20% above basal offer (Intervention II) in the same~     way.The second treatment (B) uses a technique of hyperinflation with the mechanical~     ventilator (PEEP-ZEEP) associated with hyperoxygenation. The intervention I, uses PEEP-ZEEP~     offering 20% above basal oxygenation and intervention II uses the PEEP-ZEEP with basal oxygen~     supply in the same way.~      All subjects were randomly allocated using sealed envelopes to a treatment sequence A or B on~     Day 1. Patients received two treatments, at least four hours apart. The first treatment is in~     the morning and the alternate treatment is performed in the afternoon. On Day 2 the order of~     the treatments was reversed using the same patient position sequence.The interventions I and~     II are performed at least 4 hours apart to minimize any carryover effect.~   "
86035|NCT02440906|"~     The Wellness Incentives and Navigation (WIN) project is designed to help improve health~     self-management and reduce the incidence and consequences of chronic disease among~     non-elderly adult Medicaid Supplemental Security Income (SSI) beneficiaries. WIN targets SSI~     beneficiaries with behavioral health (mental health and substance abuse) diagnoses. Research~     demonstrates that these individuals are more likely to suffer chronic physical~     co-morbidities, experience debilitating chronic illnesses earlier in life and have elevated~     healthcare costs.~      WIN uses person-centered wellness planning and navigation facilitated by trained,~     professional health Navigators, dedicated specifically to the WIN project, who use~     Motivational Interviewing (MI) techniques, and a personal wellness account. Participants with~     more serious mental illnesses will be offered additional support in the form of Wellness~     Recovery Action Planning (WRAP) to enable them to take full advantage of person-centered~     wellness planning.~   "
86036|NCT02440893|"~     The study goal was to understand the effect of Metformin on Age/Sex/Gene Expression Score~     (ASGES) or Corus CAD (henceforth Corus) in pre-diabetic patients who are medication naive.~     This study provided data to determine if the Corus CAD (ASGES) signature was different in~     pre-diabetic patients when metformin was newly prescribed and taken.~   "
86037|NCT02440880|"~     Nowadays Cesarean sections became the most popular surgery worldwide with the consumption of~     the hospital resources and the continuous need to decrease the costs, work load and medical~     stuff engagement. One of the most common problem is the need to control pain post~     operatively, this issue increase the work load over the pain management team and increase~     lead to patient in satisfaction.~      This study will test the usage of dexamethasone with different doses (4 and 8 mg) either~     locally or intravenously (I.V.) with the local anesthetics in TAP (transversus abdominis~     plane) block to prolong the duration of the block and decrease the need of post-operative~     analgesics.~   "
86038|NCT02440867|"~     The purpose of the study is to test a new treatment of social cognition deficits in patients~     with schizophrenia or schizoaffective disorder by transcranial magnetic stimulation~     (theta-burst). The study will also identify clinical variables, cognitive and psychomotor~     most sensitive to treatment, to estimate the most sensitive treatment target, assess~     tolerance, to assess the impact of repetitive Transcranial Magnetic Stimulation (rTMS) on the~     brain a multimodal imaging study and compare the imaging variables (resting network,~     Diffusion Tensor Imaging, magnetic resonance spectroscopic imaging; MRSI) between patients~     before treatment and healthy subjects.~   "
86229|NCT02438371|"~     Tocolytic agents are used for the treatment of preterm labor. It is unclear whether~     combination treatments of two tocolytic agents are more effective in stopping preterm labor~     compared to one. Therefore, the investigators propose a comparative effective trial of~     nifedipine plus indomethacin vs. nifedipine alone for the treatment of preterm labor~   "
86039|NCT02440854|"~     This non-interventional study will include a representative sample of patients with locally~     advanced or metastatic NSCLC harboring Epidermal Growth Factor Receptor (EGFR)-mutations in~     Greece. Eligible NSCLC patients, for whom the physician has decided to initiate treatment~     with the study medication (afatinib, GIOTRIF®) will be treated according to the local~     prescribing information and standard medical practice in terms of visit frequency and types~     of assessments performed.~      The study will investigate the impact of GIOTRIF (Afatinib) on patients' disease-related~     symptom burden and Health-Related Quality of Life (HRQoL) in a real world clinical setting in~     Greece.The Average Symptom Burden Index (ASBI) score of the Lung Cancer Symptom Scale (LCSS)~     in eligible patients, after 6 months of therapy, will be analyzed.~      The overall study duration period is expected to be 48 months, including a 36-month~     enrollment period and a minimum 12-month follow-up period.~   "
86040|NCT02440841|"~     The purpose of this study is to investigate the potential for co-administration of strong~     inhibitors or inducers of CYP3A4 to alter the pharmacokinetics of fedovapagon.~   "
86041|NCT02440828|"~     This study evaluates the addition of tobramycin inhalation treatment to standard intravenous~     therapy in the treatment of ventilator associated pneumonia.~   "
86042|NCT02440815|"~     The specific focus of this study is to gather data regarding the effects of a psychological~     therapy known as Problem Solving Therapy (PST) on cerebral blood flow (CBF), cortical gray~     matter (GM) atrophy, subcortical white matter (WM) lesion burden, and measures of cognitive~     function in subjects with Late Life Major Depressive Disorder (LLD). This research goal will~     be achieved by recruiting 110 individuals over the age of 65 with LLD. The primary outcomes~     will be change in CBF, change in GM atrophy, change in WM lesion, change in cognitive~     function, and change in depression severity from baseline to the end of 12 weeks of PST.~   "
86043|NCT02440802|"~     Androgen deprivation therapy (ADT) by surgical castration or administration of LHRH agonists~     or antagonists is the gold-standard systemic treatment of Prostate Cancer. The efficacy,~     severity and frequency of side effects of ADT vary from a patient to another. The exact cause~     of this variability is not known, however certain genetic polymorphisms affecting enzymes~     implicated in the synthesis and metabolism of sex-steroids seem to be involved in these~     processes.~      To perform a longitudinal study to evaluate the prevalence of various genetic polymorphisms~     affecting genes in the sex-steroid synthesis and metabolism pathway (CYP1A1, CYP1B1, CYP19A1,~     17HSD, HSD3B1, AR, ESR1, ESRRG, IL6, TNF-alpha) in men with Prostate Cancer receiving ADT and~     the possible association between polymorphisms and frequency and severity of side-effects of~     ADT.~   "
86044|NCT02440789|"~     The purpose of this study is to find out about the safety of sirolimus in individuals with~     HIV infection who are also being treated with ART. The investigators want to learn whether~     sirolimus will decrease inflammation and immune activation in the body; whether sirolimus~     will change the level of HIV in the participants' blood; and how sirolimus interacts with ART~     in the blood. Sirolimus is approved by the Food and Drug Administration (FDA) to prevent~     organ rejection in patients aged 13 years and older receiving kidney transplants. Sirolimus~     has also been used for the prevention of complications after stem cell transplants and as a~     treatment for certain kinds of cancers in HIV-infected patients.~   "
86045|NCT02440776|"~     Monitor the safety and performance of the Pulsante Microstimulator System.~   "
86046|NCT02440763|"~     The key goals of EUROSCA-NHS is to determine and compare the rate of disease progression in~     SCA1, SCA2, SCA3 and SCA6 including determination of the order and occurrence of non-ataxia~     symptoms, assessment of activities of daily living (ADL) and quality of life (QoL), and~     identification of predictors of disease progression and survival.~   "
86047|NCT02440750|"~     The presence of a thin endometrium has an important role in allowing the best conditions for~     hysteroscopic surgery. The aim of this study is to evaluate the efficacy of a 21 day~     administration of 2 mg of dienogest versus ulipristal acetate 5 mg, in rapid endometrial~     preparation to operative hysteroscopy.~   "
86048|NCT02440737|"~     This pilot clinical trial studies the Navigated Early Survivorship Transition (NEST)~     intervention in improving survivorship care planning in patients with newly diagnosed cancer~     and their caregivers. A survivorship care planning session (SCPS) delivered to survivors and~     their primary caregivers may improve psychosocial well-being, patient and caregiver~     engagement, and adherence to treatment and follow-up recommendations. It is not yet known~     whether a NEST intervention or usual care is better in improving survivorship care planning~     in patients with newly diagnosed cancer.~   "
86049|NCT02440724|"~     The purpose of this study is to evaluate usefulness of new designed winged stent(SEMS).~   "
86050|NCT02440711|"~     The goal of this study is to evaluate endurance, walking performance, mobility, and perceived~     exertion of transtibial prosthesis users (i.e., study participants) walking with a~     conventional energy storing prosthetic foot (ESF) and a novel modified running-specific~     prosthesis (mRSF). A randomized cross-over study will be conducted to determine if the mRSF~     provides superior performance to the ESF, which is commonly prescribed to most active~     individuals with lower limb amputation.~   "
86051|NCT02440698|"~     The investigators will use a web-based survey to collect data on individual attitudes and~     self-reported health behaviour changes following genetic testing for personalized nutrition.~     Participants (n=80) are employees of a large multi-national food company's R&D division~     located in Australia, Switzerland, USA and the UK. They underwent a genetic test for~     personalized nutrition in March 2015 that was offered at no cost through the company wellness~     program. A registered dietitian completed a pre-test consultation and disclosed the test~     results with DNA-based dietary advice. The test provided information on 7 components of diet~     and additional information on individual risk for gluten intolerance.~   "
86052|NCT02440685|"~     This study is a dose escalation, and cohort expansion study in subjects with advanced cancer~     for which no standard therapy exists. Subjects must have received prior treatment for cancer~     that has not worked, or has stopped working.~   "
86053|NCT02440672|"~     The purpose of this study is to evaluate the safety and effectiveness of the JOURNEY™ II CR~     Total Knee System in subjects with degenerative joint disease (DJD) requiring primary total~     knee replacement.~   "
86265|NCT02437903|"~     This study is to determine the efficacy and safety of JUVÉDERM VOLUMA™ XC when used in the~     facial temporal regions based on the change in the score of the investigator's Temporal. This~     study will be an open label, single center study.~   "
86054|NCT02440659|"~     Empowering Patients On Choices for Renal Replacement Therapy (EPOCH-RRT) study seeks to~     identify factors that matter the most to patients with kidney disease and study how they are~     impacted by different types of dialysis. The inclusion of patients, caregivers, and patient~     advocacy organizations as research partners will assure that the study addresses questions of~     greatest relevance to patients facing the need for dialysis.~      Aim two is based on preliminary results of Aim one interviews, and in collaboration with the~     Patient Advisory Panel, the investigators developed a brief questionnaire to be administered~     to participants in the Dialysis Outcomes and Practice Patterns Study (DOPPS) and Peritoneal~     Dialysis Outcomes and Practice Patterns Study (PDOPPS). Two separate versions of the~     questionnaire were created to reflect unique aspects of in-center hemodialysis (HD) and~     peritoneal dialysis (PD).~   "
86055|NCT02440646|"~     In a prospective cohort single-center observational study, 720-1080 chest pain patients~     ('all-comers' REALITY registry of CTA patients, Ural Institute of Cardiology, Yekaterinburg,~     Russia; www.cardio-burg.ru) with or without acute coronary syndrome will be enrolled who~     admitted to the chest pain outpatient center (The Heart Clinics, Yekaterinburg, Russia;~     www.hclinic.ru) between September 2010 and May 2015 underwent functional testing and computed~     tomography angiography, and/ or 3D quantitative coronary angiography with or without further~     percutaneous coronary intervention. Subsequent plaque burden/ % stenosis (adjusted with~     technical limitations of CTA and 3D QCA), major adverse cardiovascular events (death from~     cardiac causes, cardiac arrest, myocardial infarction, or rehospitalization due to unstable~     or progressive angina) will be judged to be related to either originally treated (culprit)~     lesions or untreated (non-culprit) lesions. Moreover, the clinical potential of CTA vs 3D QCA~     in two real-world patient flows of the Chest Pain center will be estimated with the special~     focus on safety (contrast-induced nephropathy, radiocontrast-induced thyroid dysfunction, and~     radiation dose). The diagnostic accuracy of both CTA and 3D QCA will be analyzed in deceased~     patients.~      The follow-up period will achieve 3-5 years when retro- and prospectively collected clinical~     events and imaging outcomes will be determined at the hospital, in 1, 6, 12, 24, 36, 48 and~     60 months after the first imaging examination.~      The independent ethics expertise will be provided by the Ural Medical University,~     Yekaterinburg, Russia (www.usma.ru). The monitoring of the clinical data with imaging as well~     as further CoreLab expertise (software of Medis) will be provided by De Haar Research~     Foundation, Rotterdam, the Netherlands.~   "
86056|NCT02440633|"~     To obtain absorption, metabolism and excretion data for parent drug and any metabolites.~   "
86057|NCT02440620|"~     This study will describe the epidemiology including prognosis of heart failure related to~     treatment with anthracycline and trastuzumab for breast cancer.~      In a prospective study Human Epidermal Growth Factor Receptor 2 (HER2) positive breast cancer~     patients scheduled for trastuzumab treatment at Odense University Hospital, will be offered~     advanced echocardiographic examination, test of bio-markers and genetic markers for the~     purpose of investigating if early identification of patients in particular risk of developing~     heart failure is feasible.~   "
86058|NCT02440607|"~     Clinical decision support tools with in the electronic medical record can improve clinical~     care processes. To date, there is little evidence evaluating crisis management with such~     decision support tools. The investigators aim to create an electronic cognitive aid with~     embedded decision support to aid clinicians during the management of a crisis. In order to~     test the effectiveness of this tool, investigators seek to compare the simulated medical~     management of a crisis (malignant hyperthermia) using a traditional cognitive aid (laminated~     card) versus a dynamic electronic visual aid with decision support.~   "
86059|NCT02440594|"~     The purpose of the current project is to evaluate the impact of the PACE/PACENET BHL clinical~     program on older Pennsylvanians and to evaluate the feasibility and impact of an enhancement~     to the current clinical program. In order to meet this objective, the following primary~     questions will be addressed in the current project: Is the current PACE/PACENET BHL Clinical~     Program associated with improvements in behavioral health outcomes among older adults newly~     prescribed an antidepressant, antipsychotic, or anxiolytic? Is the current PACE/PACENET BHL~     Clinical Program associated with improved access to and delivery of evidence-based care? Is~     the Enhanced PACE/PACENET BHL Program associated with better outcomes than the current~     PACE/PACENET BHL Clinical Program?~   "
86060|NCT02440581|"~     Renal osteodystrophy (ROD) represents the bone histologic abnormalities resulting from loss~     of renal function. It starts early during the loss of kidney function and is seen in~     virtually all chronic end stage kidney disease patients on dialysis (CKD-5D). A major~     component of ROD is bone loss leading to chronic kidney disease (CKD) associated~     osteoporosis. Debilitating hip fractures occur in patients with CKD at a rate 4.4 times~     higher than in the general population, with associated high costs, morbidity and an annual~     mortality of 64%. CKD osteoporosis is distinctly different from post-menopausal osteoporosis.~     Presently, no uniformly accepted CKD osteoporosis treatment protocol exists because of~     challenges related to racially specific bone turnover states. Therefore, most physicians are~     reluctant to treat this disorder despite the profound impact on health and quality of life,~     and its association with vascular calcifications. These vascular calcifications confer an~     increased risk for cardiovascular events which are the major cause of the over 20% annual~     mortality rate in CKD-5D patients.~      The goal of the proposed controlled randomized study is to test the concept that CKD~     osteoporosis can be successfully treated when treatment is individualized by patients'~     turnover status. The study will demonstrate that reversal of bone loss can be achieved by~     increasing bone formation in low turnover patients, and by reducing bone resorption in normal~     or high turnover patients. A second aim of this study is to provide new information whether~     these treatments will also retard progression of vascular calcifications. Blood tests~     measuring FGF23, indicators of Wnt pathway activity, bone resorption and formation will be~     followed to understand potential mechanisms and to evaluate their usefulness for prediction~     of changes in bone mass and vascular calcifications.~      CKD-5D patients with established osteoporosis will be enrolled into one of two treatment arms~     based on bone turnover status. Each arm will be adaptively randomized by race, age and gender~     into treatment or control groups. In the low turnover arm, teriparatide combined with~     cinacalcet will be given, and in the normal or high turnover arm, alendronate will be~     administered. Bone mineral density will be measured at baseline and after one year of~     treatment by quantitative computed tomography. Calcifications of the coronaries, aorta and~     heart valves will also be measured at the same times by multi-detector computed tomography.~      If this proof-of-concept study is successful, it will offer a heretofore unavailable~     treatment for osteoporosis in CKD-5D patients thus changing the prevailing clinical practice~     paradigm. This will provide immediate benefit to CKD patients by reducing fracture risk, bone~     pain, and cardiovascular risk, while greatly improving their quality of life. These~     improvements will also convey major socioeconomic benefits by decreasing the high associated~     treatment costs. The proposed study is highly relevant to the National Institute of Diabetes~     and Digestive and Kidney Diseases' mission of disseminating science-based information to~     improve the health and quality of life for patients with endocrine, metabolic and kidney~     diseases.~   "
86061|NCT02440568|"~     This is a dose escalation study to evaluate Omacetaxine when given in combination with a~     standard induction regimen of 7+3 (cytarabine for Days 1-7 and Idarubicin for Days 1-3) in~     patients with newly diagnosed acute myelogenous leukemia (AML).~   "
86062|NCT02440555|"~     Type 2 diabetes is the chronic disease with the most important development in France, and~     particularly in the Saint-Etienne area due to his specific population.~      Different studies showed the interest of screening targeted on high risk population to reduce~     cardiovascular risks and mortality.~      The current screening recommandation is an opportunist targeted screening on population older~     than 45 years with risk factors by a fasting glucose every 3 years, and a communautaire~     screening targeted on population older than 45 years suffering precarity with or without risk~     factors by capillary blood glucose or fasting glucose.~      The objective of the Sainté Diabete network is to optimize the screening of diabetics, their~     follow-up and their treatments. Using a self-administered questionnaire during a medical~     visit could be a simple, cheap and efficient tool to detect diabetics as soon as possible.~   "
86063|NCT02440542|"~     The purpose of this study is to evaluate outcomes of popliteal nerve blocks for postoperative~     pain control in patients undergoing ankle and hindfoot reconstruction surgeries. The~     following outcomes will be analyzed: length of hospital stay, level of pain control, pain~     medication use, complications, and patient satisfaction.~   "
86064|NCT02440529|"~     In this study, the investigators are interested in evaluating the impact of an orthopaedic~     related smoking cessation discussion after fracture surgery.~   "
86153|NCT02439372|"~     Consequences of latent cytomegalovirus (CMV) infection reactivation on ulcerative colitis~     flare, as a flare-worsening factor or simple bystander, are debated. Theoretically,~     CMV-specific cell-mediate immune response will further categorize the patients into high or~     low risk of CMV colitis. The investigators thus evaluate the usefulness of CMV-specific~     ELISPOT assay in patient with ulcerative colitis flare to assess the the impact of CMV~     colitis on ulcerative colitis flare.~   "
86065|NCT02440516|"~     Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system (CNS)~     and the most common cause of non-traumatic disability in young adults in western countries.~     Despite increasing therapeutic options to ameliorate the disease course, most patients suffer~     from persistent neurological deficits over time.~      Disability in MS has a negative impact on patients life's impairing activities of daily~     living (ADL) and quality of life (QoL) and leading to loss of work and the need providing~     care. This results in tremendous socioeconomic burden.~      Disease-modifying treatments prevent disability progression in variable extent. However no~     drugs are available ameliorate persistent disability in MS. Therefore, exercise training as~     well as physical and occupational therapies are important in the symptomatic treatment of MS.~      Physical and occupational therapy is usually performed close to patients home by therapist~     with different professional background in a non-standardized way.~      The investigators therefore aim to develop a standardized comprehensive ambulatory~     neurorehabilitation program, integrating task oriented circuit training for MS patients to~     improve disability, ADL and QoL that can be easily adopted in other ambulatory or hospital~     settings.~   "
86066|NCT02440503|"~     The investigators research group conducted a feeding study in 2012 (IRB 07-0003) that~     included breastfed infants consuming different infant solid foods. The investigators results~     showed that different solid foods, especially the protein content of the food, is important~     on infant's gut bacteria profile and growth. Although the first year of life is critical in~     obesity development later in life, data are very limited on the effect of protein from solid~     foods, an important component of infant diet, especially in breast-fed infants. In this~     study, the investigators will re-contact these participants, who are now in their early~     childhood (~5 years old), to evaluate the long-term effect of various macronutrient~     quantities in solid foods, by assessing the participants' growth, body composition, and gut~     bacteria profile.~   "
86067|NCT02440490|"~     Cognitive difficulties often occur with chronic pain. The aim of this randomised controlled~     trial is to determine whether various aspects of cognitive function can be improved. An~     8-week course of cognitive training via a web-based training program (3 times per week) will~     be contrasted with watching informative documentary videos (for the same length of time).~     Outcomes include subjective and objective measures of cognition, as well as self-report~     measures of mood and pain.~   "
86068|NCT02440477|"~     Background: Shoulder pain is the third most common musculoskeletal problem accounting almost~     21% of all musculoskeletal complaints. Symptomatic Rotator cuff degenerative tears (RCDT) are~     mostly common above the age of 40. Deviations of posture in the upper quadrant such as,~     slouched posture and forward head position, have been linked repeatedly to rotator cuff~     diseases, altered scapular kinematics and changes in the acromiohumeral distance (AHD). No~     study yet examined the effect of changing posture in sitting on the output of shoulder~     clinical tests, in patients with RCDT.~      Objectives: The primary objective of the study is to examine the effect of changing posture~     in sitting on selected clinical shoulder tests in patients with rotator cuff degenerative~     tears (RCDT) Study design: A single blinded controlled clinical trial Methods: A total of 100~     subjects (Patients referred to physiotherapy outpatient clinics of Clalit Healthcare Services~     in Holon and Hertzlyia) will be included in this study and divided into 2 groups: 50 subjects~     with shoulder pain who are diagnosed with RCDT by ultrasound and a control group of 50~     volunteering subjects without any pain in the upper quadrant. All patients will be measured~     for their body weight and height and their hand dominance will be notified. Following~     reliability trials on the first 10 subjects, all subjects will be tested for pain provocation~     and level of pain (VAS) in both shoulders with 3 commonly used clinical shoulder tests for~     the diagnosis of rotator cuff diseases (Empty can - sensitivity=94%, specificity = 46% Neer~     test - sensitivity = 72%, specificity = 60%, and Hawkins-Kennedy test - sensitivity = 79%,~     specificity = 59% ) in 3 sitting postures; normal resting posture, slouched posture, and~     upright posture with scapular retraction as described by Kalra et al (2010). In addition, the~     rotator cuff muscle strength tests during shoulder abduction, internal rotation and external~     rotation will be measured for the 2 shoulders using a hand-held dynamometer.~   "
86069|NCT02440464|"~     This study is designed to compare progression-free survival (PFS) from randomization among~     patients randomized on the BMT CTN 1302 protocol, Multicenter Phase II, Double-blind Placebo~     Controlled Trial of Maintenance Ixazomib after Allogeneic Hematopoietic Stem Cell~     Transplantation for High Risk Multiple Myeloma. It is hypothesized that Ixazomib maintenance~     therapy will result in improved PFS in patients with high-risk multiple myeloma following~     Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) compared to placebo.~   "
86070|NCT02440451|"~     This study aims to demonstrate that fMRI neurofeedback training improves the identification~     and comprehension of emotional facial expressions (and overall social behaviour) in subjects~     with ASD.~      The intervention setup provides structured presentation of emotional facial expressions and~     the associated tools for mental imagery. The investigators hypothesize that the~     accomplishment of the proposed competence training improves the subjects ability to~     comprehend facial expressions, identify emotions and be able to correctly express them.~      Intervention Type is a Device (brain computer interface using brain imaging signals) and the~     specific Intervention Name is Neurofeedback.~      Structure: (1) initial eligibility screening, (2) pre-intervention (first week of study,~     baseline outcome measures and additional evaluations), (3) intervention process (8 weeks),~     (4) post-intervention (outcome measures and additional evaluations), and (5) follow-up~     (outcome measures at 6 months).~   "
86071|NCT02440438|"~     Clostridium difficile is responsible for up to 25% of reported antibiotic associated diarrhea~     cases and virtually all cases of pseudomembranous colitis (PMC). The clinical spectrum of C.~     difficile infection (CDI) varies in severity from asymptomatic carriage to self-limited,~     mild, watery diarrhea, to PMC, intestinal perforation, toxic megacolon, sepsis, fulminant~     colitis, and death. In the past decade, the 027/NAP1/BI strain has emerged world-wide and has~     been implicated in large outbreaks with increased severity, frequent recurrence, and~     significant mortality. The host immune responses can influence the severity of CDI and play~     crucial roles in CDI onset, progression, and overall prognosis. Low serum concentrations of~     antibodies directed against the toxins A&B of C. difficile have been associated with a higher~     risk of recurrence. However, there are conflicting reports.~   "
86072|NCT02440425|"~     The purpose of this study is to find out if the combination of Paclitaxel once per week with~     Pembrolizumab once every 3 weeks will help participants with this disease. Researchers want~     to find out the effectiveness of the drug combination to improve the delay of cancer~     progression or death and compare it to historical data for weekly paclitaxel alone, and~     assess safety.~   "
86073|NCT02440412|"~     This study evaluates the effect of a single session of Massage Therapy in salivary cortisol~     level. All participants were assessed on three conditions: Massage session, rest in supine~     position listening music, and under normal working conditions. The hypothesis of the~     investigators is that the effect of the massage action in reduction of cortisol is superior~     to only rest.~   "
86076|NCT02440373|"~     Cytochrome c is a mitochondrial protein that plays a key role in energy metabolism. When~     mitochondria are injured, cytochrome c may leave mitochondria and reach the bloodstream. The~     investigators plan to investigate whether circulating cytochrome c levels may serve as~     biomarker of traumatic injury correlating with (1) severity of traumatic injury, (2)~     development of organ dysfunction, and (3) clinical outcomes. The Trauma Services at ALGH will~     enroll over 8 months 100 consecutive trauma patients who require intubation for mechanical~     ventilation and survive to hospital admission. The Resuscitation Institute at RFUMS will~     measure cytochrome c levels in plasma taken upon hospital admission and subsequently at 24,~     48, and 72 hours, with additional plasma stored for markers to be defined at a later time.~     Blood cytochrome c levels will be analyzed in relation to severity of traumatic injury,~     development of organ dysfunction, and clinical outcomes including survival and functional~     status (adjusted for covariates such as age, gender, type of trauma, time to stabilization,~     comorbidities, etc.) using information obtained as part of routine medical care. Successful~     completion of this project will support blood cytochrome c as biomarker of traumatic injury~     which could be used to identify severity, predict outcomes, and assess novel mitochondrial~     protective strategies.~   "
86077|NCT02440360|"~     Santa Clara County has partnered with Abode Services to provide 112 units of permanent~     supportive housing (PSH) for up to 6 years for chronically homeless individuals with multiple~     co-morbidities who are high cost users of services in the County. Because the target~     population of high cost users who are chronically homeless greatly exceeds the supply of~     permanent supportive housing to be made available via this mechanism, the County plans to use~     this opportunity to examine the effectiveness of PSH compared to treatment as usual by~     ethically allocating a limited resource using a lottery type system for eligible individuals~     who consent to participate in the Pay For Success (PFS) initiative. Specifically, while there~     are estimated to be over 2,500 people in Santa Clara who would be eligible for participation~     on any given night, the PFS program will only provide 112 PSH units at any given time. As the~     study duration will last six years, the investigators anticipate that approximately 150-200~     people will be housed via this mechanism. Outcomes will be reported to the Institutional~     Review Board (IRB) on a quarterly basis and will be based on scheduled quarterly reports~     provided to the county.~      This evaluation will be a randomized controlled trial comparing the outcomes for chronically~     homeless individuals randomized to receive PSH to those who are randomized to receive usual~     care. The aims of this study are to:~        1. measure months of stable tenancy for individuals who are placed in PSH;~        2. examine differences in utilization of health services and the criminal justice system;~          and~        3. monitor the changes in use of longitudinal care.~      All data utilized for this evaluation will be County administrative data. The investigators~     hypothesize that some costly and acute health services utilization will decrease over time~     for the intervention group, while other more sustaining health services will increase.~   "
86078|NCT02440347|"~     The purpose of this study was to investigate and compare pulpal anesthesia and cardiovascular~     parameters obtained with 0.6 ml of 4% articaine with epinephrine (1:100.000) for anterior and~     middle superior alveolar nerve (AMSA) block performed by standard and computer-controlled~     delivery in healthy volunteers.~   "
86079|NCT02440334|"~     The purpose of the proposed trial is to determine whether contrast-enhanced ultrasound (CEUS)~     can be used to assess the recurrence of renal cell carcinoma (RCC) after cryoablation~     compared to contrast enhanced CT or MR (the standard evaluation). This study involves the~     off-label use of an FDA-approved ultrasound contrast agent, Optison that flows in the~     vascularity. CEUS will be performed by both two and three dimensional ultrasound to examine~     post-cryoablation vascularity changes to screen for recurrent disease.~   "
86080|NCT02440321|"~     The purpose of this project is to develop and examine the effects of a parent-child~     interactive program to decrease the level of children's exposure to environmental tobacco~     smoke(ETS) at home, promote parents' and children's preventing strategy, knowledge of its~     hazard and attitude against environment tobacco smoke. A clustered randomized controlled~     trial was administered to school-aged children and their parents. The outcome indicators,~     children's exposure to ETS at home and increase of strategy to prevent the exposure were~     measured at baseline, 8 weeks, and 20 weeks. The other outcomes, parents' and children's~     knowledge of and attitude toward ETS, family's anti-ETS climate and its influence, and~     children's self efficacy of avoiding ETS were also measured at the same time point.~   "
86081|NCT02440308|"~     This clinical trial studies the use of gallium-68 (68Ga)-DOTA-Bombesin as the imaging agent~     for positron emission tomography (PET)/magnetic resonance imaging (MRI), collectively~     PET-MRI, in patients with prostate cancer. PET uses a radioactive substance called~     68Ga-DOTA-Bombesin, which attaches to tumor cells with specific receptors on their surfaces.~     The PET scanner takes pictures that capture where the radioactive drug is lighting up and~     attaching to tumor cells, which may help doctors recognize differences between tumor and~     healthy prostate tissue. MRI uses radio waves and a magnet to make a picture of areas inside~     the body. Using 68Ga-DOTA-Bombesin in diagnostic procedures, such as PET/MRI, may allow~     doctors to identify smaller tumors than standard imaging.~   "
86082|NCT02440295|"~     The purpose of the study is to evaluate the use of the SPY Elite System to assess real-time~     tissue perfusion of lower extremity amputation sites and to develop parameters to predict~     healing of amputations at the time of surgery.~      This is a pilot study to see if the Spy Elite System is capable of recording accurate~     measurements on amputation sites to allow some correlation to healing. If this study shows~     promise for the device, the investigators would plan a larger study in which the data would~     be assessed in the operating room at time of acquisition and revision performed if needed~     based on the findings.~   "
86083|NCT02440282|"~     Diabetic foot ulcer is the most common cause of non traumatic lower extremity amputations~     (LEA) associated with diabetes. Traditionally general and spinal anesthesia were the~     preferred modality of anesthesia. The use of sciatic nerve block has recently gained~     popularity, however, without the supporting evidence of any benefits. This study was to~     evaluate the comparison of anesthesia modalities for hemodynamic stability and postoperative~     pain in diabetic foot patients undergoing minor LEA.~   "
86084|NCT02440269|"~     The purpose of this study is to determine whether the Circadian Rhythms effects on the~     Norctrend Index in Anesthesia.~   "
86085|NCT02440256|"~     Opioid Substitution Treatment (OST) provides a critical opportunity for HIV testing and~     linkage to antiretroviral treatment. The EHOST study will evaluate a prescriber-focused~     intervention to increase HIV testing rates, and optimize antiretroviral treatment,~     re-engagement and retention outcomes among individuals engaged in OST. 46 OST sites in~     British Columbia will be randomly allocated into three clusters. Clusters will initiative the~     intervention at different time points, or steps, with every cluster receiving the~     intervention.~   "
86154|NCT02439359|"~     A Phase 1, Placebo-Controlled, Dose-Escalating Study to Examine the Safety and Tolerability~     of Single Intravenous Doses of CF-301 in Healthy Subjects.~   "
86086|NCT02440243|"~     Background There is limited evidence indicating that specific immunotherapy in elderly~     patients is safe and effective. This study was performed to evaluate the safety and efficacy~     of specific subcutaneous immunotherapy (SCIT) against grass pollen allergens in patients over~     60 years of age with seasonal allergic rhinitis (SAR) and a confirmed allergy to grass~     pollen.~      Objective This study assessed the safety and efficacy of SCIT for grass pollen allergens in~     elderly patients with SAR.~      Methods This study included 62 60- to 75-year-old patients with SAR and grass pollen allergy~     confirmed using a skin prick test, nasal provocation, and serum IgE measurement. The patients~     were individually randomized to the active or placebo groups using a double-blinded method.~     There were 33 subjects in the SCIT group (Purethal, Grass pollen, HAL Allergy B.V, Leiden,~     Netherlands) and 29 subjects in the placebo group monitored for three years. The patients~     were required to record each use of anti-allergy medication in a diary and use a visual~     graphic scale. The main outcome measure was the area under the curve (AUC) for the combined~     symptom and medication score (SMS).~   "
86087|NCT02440230|"~     To compare safety of adjuvant OFS combined with anastrozole versus OFS combined with~     exemestane in Chinese premenopausal hormonal receptor(HR) positive breast cancer patients.~   "
86088|NCT02440217|"~     Dilated cardiomyopathy (DCM) is characterized by a metabolic shift from fat to carbohydrates~     and failure to increase myocardial glucose uptake in response to workload increments. The~     investigators aimed at verifying whether this pattern is influenced by the presence of~     abnormal glucose tolerance (AGT).~   "
86089|NCT02440204|"~     Intubation is a procedure that requires well relaxed muscles while general anesthesia is~     performed. In order to get adequate muscle relaxation, remifentanil, sevoflurane or both~     agents in combination have been reported as they can provide adequate conditions for~     laryngoscopy and tracheal intubation without using muscle relaxants.~      However, there were no previous studies to find the effective dose of sevoflurane in~     combination with different bolus doses of remifentanil to obtain adequate endotracheal~     intubation conditions without using muscle relaxants. The aim of this study is to investigate~     the change in the minimum sevoflurane alveolar concentration which produces an adequate~     endotracheal intubation condition when sevoflurane is combined with different bolus doses of~     remifentanil used in clinical practice.~   "
86090|NCT02440191|"~     It has been not clinically determined whether TomoDirect was dosimetrically better than~     3D-CRT for Asian patients with early breast cancer. Therefore, the objective of this study~     was to compare dosimetric parameters of TomoDirect and 3D-CRT in early breast cancer patients~     of an Asian cohort.~   "
86091|NCT02440178|"~     The purpose of this study is to determine whether prophylaxis with micafungin is effective in~     the induction chemotherapy for newly diagnosed acute leukemia patients.~   "
86092|NCT02440165|"~     Early nursing nutrition intervention for outpatients in need of surgery~        -  Objective - To investigate the feasibility and effectiveness of screening and an early~          nursing intervention on malnutrition in outpatients in need for surgery.~        -  Design - Multi-centre cluster-randomised controlled early trial design (n=150 patients)~        -  Intervention - Malnutrition screening (during outpatient clinic visit) and (in case of~          patients being ´at risk for malnutrition´ or being ´malnourished´), a nutrition care~          plan (including nutritional drinks and energy and protein rich meals) tailored to~          individual patient requirements~        -  Comparison - Usual care (no nutritional care plan)~   "
86093|NCT02440152|"~     The nucleus accumbens (NAcc) has a significant role in the process of opiate addiction and~     the initiation of relapse after detoxification. There is evidence that deep brain stimulation~     (DBS) of the NAcc exerts a positive effect on individuals with severe heroin addiction via~     inhibitory action .~      The investigators hypothesise that bilateral stimulation of the NAcc will significantly~     reduce withdrawal symptoms and thus enable the patients to substantially decrease their~     Levomethadone usage.~   "
86094|NCT02440139|"~     STUDY DESIGN:~      This is a retrospective, multi-reader, multi-case, (MRMC) randomized reader study.~      OBJECTIVE:~      Primary: The primary objective of this clinical study is to prove that a user aided with~     ClearRead CT InSight (CRCTI) is superior to the unaided reader for detecting actionable lung~     nodules.~      Secondary: The secondary objective of this clinical study is to prove that the reader's~     reading time is not significantly increased when aided with CRCTI.~      NUMBER OF SUBJECTS:~      Retrospective CT studies from approximately 300 patients will be included in the study.~     Approximately 100 true positive cases and 200 normal cases.~      NUMBER OF READERS:~      A reader study with at least ten (10) participating radiologists (US Board Certified) will be~     conducted.~      PRIMARY ENDPOINTS:~      Scores given by the radiologists with and without ClearRead CT Insight will be recorded and~     compared to the true status of the study-cases. The frequency of the scores for each method~     (Unaided, Aided) will be tabulated and LROC curves constructed along with sensitivity,~     specificity, PPV, NPV and clinical actions. Additionally, machine nodule detection rate and~     false positives per patient on normal cases will be measured.~      PATIENT POPULATION :~      The study will target approximately one hundred (100) patients whose CT nodules were shown to~     be cancer and two hundred (200) normal patients. The patient population will be consistent~     with the national lung cancer screening protocols.~   "
86095|NCT02440126|"~     The purpose of the study is to develop an improved understanding of the long term~     pharmacokinetics and pharmacodynamics of natalizumab with both standard dosing and extended~     dosing, and collect additional samples to explore cell-based biomarkers of natalizumab~     treatment and PML risk.~   "
86096|NCT02440113|"~     Multicenter retrospective CT follow up after aortic aneurysm repair using Nellix~     Endoprosthesis.~   "
86097|NCT02440100|"~     This is an investigator-and-subject blind, phase 1 study to characterize the safety,~     tolerability, pharmacokinetics and central and peripheral pharmacodynamics of 14-day repeated~     ascending doses of PF-06648671 once a day in healthy adults (part 1) and repeated doses at~     the maximum tolerated dose (MTD) defined in part 1 in healthy elderly subjects (part 2). The~     study also include an optional cohort (part 3) to evaluate the drug interaction between~     PF-06648671 at MTD and CYP3A probe, midazolam~   "
86155|NCT02439346|"~     Determine the safety, tolerability, maximum tolerated dose (MTD), pharmacokinetics (PK),~     and/or recommended Phase II dose (RP2D) of oral BAY 1143269 given alone or in combination~     with intravenous (IV) docetaxel in subjects with advanced solid tumors.~   "
86098|NCT02440087|"~     This is a cohort, observational, prospective, multicenter, longitudinal study. 100 patients~     will be followed postoperatively for a period of 12 months. Intermediate statistical analyzes~     will be performed at 1 month, 3 months, 6 months and 9 months.~      This observational study is non-interventional, it does not change the usual care of patients~     who underwent a bariatric surgery. Data collection will be carried out during routine visits~     planned in the post-operation usual follow-up. The blood tests are part of the patient's~     usual care for his bariatric surgery.~      Surgeons will include patients for whom they have freely decided to use the dietary~     supplement Refill under the care of the treatment of obesity. The motivation of the patient~     and his commitment to the project is evaluated by the surgeon.~      The main objective is to evaluate the efficacy of the dietary supplement Refill.~      The primary endpoint is the reduction of iron deficiency.~   "
86099|NCT02440074|"~     This trial pretends to validate for clinical use a bioengineered product composed of~     mesenchymal stem cells produced by the Instituto de Biologia y Genetica Molecular (IBGM),~     Valladolid (MSV, which have already been approved by the Spanish Regulatory Agency for three~     previous clinical trials) and a cross-linked matrix of autologous plasma patented by The~     Blood and Tissue Bank of Asturias (WO2008/ 119855) for bone maxillary cysts refilling. These~     two groups collaborate in the present project with the team of Maxillofacial Surgery of the~     Hospital Universitario del Río Hortega, who leads the clinical trial and deals with the~     medical aspects. The proposed trial is based on positive results obtained in previous animal~     studies performed by the present multidisciplinary team. A phase I / II clinical trial with~     10 patients suffering from bone cysts in the maxillofacial region is proposed. Autologous~     mesenchymal stem cells isolated from a bone marrow sample will be seeded in the autologous~     plasma matrix and cultivated for 3 weeks. At this time, the cyst will be removed by surgery~     and the cavity filled with the protein matrix containing the mesenchymal cells. Follow up~     tests will be conducted at 3 weeks, 3 and 6 months following the evolution of the cavity by~     panoramic radiography and computerized tomography scan.~   "
86100|NCT02440061|"~     Ghrelin is a hormone naturally produced in the stomach and the gut. The purpose of this~     research study is to determine the role of this gut hormone in the regulation of insulin~     secretion from the pancreas and glucose disposal after we eat. The investigators hypothesize~     that ghrelin has an effect on the pancreas and on how our body handles glucose after we eat.~     The investigators will compare insulin secretion and glucose changes during meal ingestion~     while either acyl ghrelin (AG) or saline (salt solution) is being infused through your vein~     on separate study days. AG is a form of the ghrelin hormone that has a small modification to~     it that allows it to bind to a specific receptor. The investigators hypothesize that AG has~     an effect on how the body handles glucose after a meal. AG has been approved by the U.S. Food~     and Drug Administration (FDA) for human research only. This study will also involve the use~     of a medicine called arginine, which is a naturally occurring product and found in many~     nutritional supplements. Its use in this study is investigational. The use of arginine helps~     maximize insulin release from the pancreas so the investigators can better examine whether AG~     affects insulin secretion.~   "
86101|NCT02440048|"~     To assess efficiency of ridge preservation (in vertical and horizontal dimensions) after~     tooth extraction using Calcium Sulfate with hydroxyapatite(®Bond-apatite) compared to the use~     of bovine bone substitute (BioOss®) and to extration only as negative control.~   "
86102|NCT02440035|"~     The purpose of this study is to assess the safety and tolerability of intramuscular~     homologous and heterologous prime-boost regimens of Ad35.RSV.FA2 (human adenovirus-vectored~     vaccine candidate) and Ad26.RSV.FA2 in healthy participants.~   "
86103|NCT02440022|"~     This prospective, global, multicenter, randomized, controlled study is designed to evaluate~     the safety and effectiveness of the Lutonix 035 AV Drug Coated Balloon PTA Catheter compared~     to a standard PTA Catheter in treating subjects presenting with clinical and hemodynamic~     abnormalities in native arteriovenous (AV) fistulae located in the upper extremity.~   "
86104|NCT02440009|"~     The study evaluates the addition of itraconazole to glucocorticoids in management of acute~     stages of allergic bronchopulmonary aspergillosis (ABPA). Half of the participants will~     receive glucocorticoids while the other half will receive itraconazole and glucocorticoids~   "
86105|NCT02439996|"~     The objective of this study is to investigate the effect of different doses of intravenous~     immunoglobulin (IVIG) (1g/kg once, 1g/kg twice, 2g/kg once) for Kawasaki disease (KD) in a~     multicentre, prospective,randomised trial.~   "
86106|NCT02439983|"~     The study is designed to evaluate the effects of the proprietary nutritional supplement on~     cognition, mood, and brain imaging parameters following a relatively short period of~     treatment.~   "
86107|NCT02439970|"~     To compare the efficacy of brincidofovir (BCV) to valganciclovir (vGCV) for the prevention of~     cytomegalovirus (CMV) disease in kidney transplant allograft recipients who are CMV~     seronegative pretransplant and received a kidney from a CMV seropositive donor~   "
86108|NCT02439957|"~     • To compare the efficacy of brincidofovir (BCV) to valganciclovir (vGCV) for the prevention~     of CMV disease in kidney transplant recipients who are CMV seropositive pretransplant and~     received antilymphocyte induction therapy~   "
86109|NCT02439944|"~     This study involves the use of personalized nicotine patch dosing as a treatment strategy for~     smokers who cannot quit smoking after 2 weeks of using the standard nicotine patch dose.~     Functional Magnetic Resonance Imaging scans will also be obtained from all study participants~     before and after treatment. The first aim of the study is to determine if the treatment~     method under investigation is safe and more effective at increasing quit rates in smokers who~     do not respond to standard therapy.The second aim is to determine if there are any treatment-~     or cessation-related changes in brain function.~   "
86110|NCT02439931|"~     Survivors of high grade brain tumours frequently experience increases in distress, cognitive~     challenges, and lessened quality of life. At the same time a range of barriers can make it~     challenging for these individuals to come into the clinic for appropriate psychosocial~     support. The proposed study is therefore a feasibility study that is designed to develop a~     manualized, remotely delivered psychosocial intervention for this population and then to test~     the acceptability, feasibility, apparent efficacy, and areas for improvement of the developed~     intervention. Further, a remote neuropsychological testing procedure will be developed and~     implemented and analogous questions will be asked around this procedure.~   "
86111|NCT02439918|"~     Kinshasa, Democratic Republic of Congo (DRC), is where human immunodeficiency virus type 1~     (HIV-1) appears to have most diversified. The factors that lead to jumpstarting the HIV-1~     epidemic remain unclear; mounting evidence suggests medical interventions may have~     contributed. Hepatitis C virus (HCV) and human T-cell lymphotropic virus type 1 (HTLV-1) are~     viruses compatible with long-term survival but with broadly similar modes of transmission as~     HIV. The main objective was to assess the association of past intravenous treatment with HCV~     and HTLV-1 seropositivity. The investigators hypothesized that medical interventions in the~     mid-20th century may have facilitated the emergence of HIV-1 in central Africa.~      To assess the association of injectable treatments with HCV and HTLV-1 infection and to~     reconstruct past virus dynamics, the investigators conducted a cross-sectional study of 839~     elderly long-term inhabitants of Kinshasa, with serological assays followed by amplification~     and sequencing. Risk factors were assessed through logistic regression. Phylogenetic methods~     were used to reconstruct the epidemic history of HCV.~   "
86112|NCT02439905|"~     During lung surgery, mechanical one-lung ventilation is usually mandatory to provide~     appropriate surgical condition. However, not only mechanical ventilation is associated with~     inflammatory response, but also one lung ventilation will result in detrimental effects such~     as ischemia and reperfusion injury, and systemic inflammatory responses.~      Dexmedetomidine is an alpha-2 selective agonist. It was reported that dexmedetomidine~     decreased reperfusion injury, reduce the release of proinflammatory mediator and protected~     lungs from reperfusion injury in esophageal cancer patients who undergoing one lung~     ventilation from reducing oxidative stress metabolites. However, other details of protective~     effects is still unknown.~      High mobility group box 1 (HMGB1) is an important proinflammatory factor. It was found to be~     related to ventilator induced lung injury in several condition. Animal studies also showed~     that dexmedetomidine reduces the expression of messenger ribonucleic acid in~     lipopolysaccharide-activated macrophage so that decrease the amount of HMGB1 release.~     However, clinical trials about these are still lacking.~      In this study, we will investigate the protective effects of dexmedetomidine to patients~     undergoing video-assisted thoracoscopic surgery, especially on the specific inflammatory~     markers- plasma HMGB1 and other inflammatory cytokines (eg. interleukin-1. interleukin-6).~     This will let us to know the role of HMGB1 during one-lung ventilation injury and the effect~     of dexmedetomidine in regulating the release of HMGB1. This study will become a basis of~     further medical therapy in treating inflammation.~   "
86113|NCT02439892|"~     Patients treated for head and neck cancer (HNC) suffer from severe side-effects such as pain~     and difficulties in swallowing, often leading to weight loss. More than 70 % of the weight~     loss is attributed to lean muscle wasting that is associated with decline in physical~     function, substantial fatigue and significantly decreased quality of life. Rehabilitation~     that includes physical exercise, nutritional counselling and oral nutritional supplements~     (ONS) can potentially reduce or prevent muscle wasting. The primary aim of this pilot~     randomised trial is to assess feasibility, evaluate patient experiences and assess~     preliminary effects on muscle mass, physical function, nutritional status and quality of life~     of rehabilitation interventions during and after radiotherapy (RT). Newly diagnosed HNC~     patients referred for curative RT with or without chemotherapy, will be randomised to a)~     rehabilitation during RT or b) rehabilitation after RT. Rehabilitation during RT will be~     carried out at an outpatient facility during the treatment period (6-7 weeks) and~     rehabilitation after RT will be carried at a rehabilitation centre and last for 3 weeks.~   "
86114|NCT02439879|"~     Patients with diabetic neuropathy and total symptoms score(TSS) >7 points were invited to~     this open multicenter study. Patients were free of pain medications and severe diabetic~     complications .Patients started alpha lipoic acid (ALA)1800 mg for 4 weeks. Patients with a~     decrease >3 points in the TSS were randomly allocated to 600 mg of ALA (ALA group) or no~     medications (ALA withdrawal) for 16 weeks. In each visit investigators evaluated any change~     in the TSS and the necessity of rescue medication to control symptoms (mainly pain). At the~     end of the study investigators compared between ALA and ALA withdrawal groups TSS levels and~     the frequency of use of rescue medications. Physicians were free to manage glucose to~     maintain Hba1c close to the ADA target (HbA1c <7%).~   "
86115|NCT02439866|"~     Patients diagnosed with NAION within 14 days of onset were included. Patients were randomized~     into 3 groups. Group 1 or control consisted of 30 patients who received gelatinous capsules~     filled with sugar as placebo. Group 2 or steroid consisted of 30 patients received~     methylprednisolone (Solu-Medrol, Pharmacia Pharmaceutical Company, Belgium) 500 mg twice a~     day for 3 days followed by 2 weeks of oral prednisolone 1mg/kg/day. Thirty patients in group~     3 or oxygen received 100% normobaric oxygen with face mask in sitting position, at a flow~     rate of 5 liters per minute for 1 hour twice a day for two weeks Functional and structural~     outcomes were assessed at 1 and 6 months following treatment. Best corrected visual acuity~     was the main outcome measure, and mean deviation index of visual field test and peripapillary~     retinal nerve fiber layer thickness were secondary outcome measures.~   "
86116|NCT02439853|"~     This is a study on Internet-based video-practice speech and language therapy for persons with~     primary progressive aphasia (PPA), behavioral-variant frontotemporal dementia (bvFTD), or~     related conditions.~   "
86117|NCT02439840|"~     In the previous study, the investigators obtained the cutoff value of Bispectral Index to~     detect early deep sedation in patients with mechanical ventilation. Bispectral Index~     monitoring can be used as an adjunct tool in screening and confirming deep sedation during~     the early period of mechanical ventilation. In present study, validation test will be carried~     out to clarify the sensitivity and specificity of obtained cutoff value in screening deep~     sedation in patients with mechanical ventilation.~   "
86151|NCT02439398|"~     Development of myocardial reparative therapy for the treatment of acute ischemic cardiac~     disease, based on the intracoronary administration of allogeneic Cardiac Stem Cells (CSCs) to~     ameliorate myocardial cell death and promote cardio-regeneration.~      The study comprises two phases:~        1. Initial dose-escalation open-label safety phase comprising 6 patients. Escalation will~          start with the Maximum Recommended Safe Dose (MRSD) calculated from Non-Observed Adverse~          Events Level (NOAEL) and it is expected to finish with the target dose (TD). There will~          be no placebo group for this initial phase.~        2. Randomized double-blind placebo-controlled safety and efficacy phase in which the TD~          will be injected if the dose-escalation phase is completed successfully.~   "
86118|NCT02439827|"~     Background:~      Interventions on lifestyle among adolescents are important, but the main mechanisms that~     explain the changes (mediating variables) on lifestyle have been little explored.~     Investigators present the rationale and methods of a cluster-randomized controlled trial~     aimed to promote promotion active and healthy lifestyle (especially physical activity [PA]~     practice and reducing screen time use) among Brazilian students - the Fortaleça sua Saúde~     (Strengthen Your Health in Portuguese) program.~      Methods/Design:~      This is a school-based cluster-randomized controlled trial that included students from six~     elementary full-time public schools (7-9 grades) in Fortaleza, northeastern Brazil. The~     intervention duration was one academic semester (approximately four months) in 2014. The~     intervention strategies focused on teachers' training and activities on health in curriculum~     (including a specific training to Physical Education teachers), active opportunities in the~     school environment (availability of spaces and materials for PA) and health education~     (production and exhibition of health material at school, and distributing pamphlets to~     patients). Data collection will be performed before and immediately after 4 months of~     intervention. The primary variables include the practice of PA (weekly PA volume) and the~     screen time use (TV/computer/video games). Intrapersonal, interpersonal and environmental~     variables associated to PA and screen time use will be evaluated by standardized~     questionnaire. Other components of the lifestyle (e.g., eating habits), psychological (e.g.,~     self-rated health, body satisfaction), biological (general and abdominal obesity) and~     academic performance will be also evaluated in the patients. Depressive symptoms, eating~     disorders, sleep quality, objectively-measured physical activity will be evaluated in obese~     patients.~      Discussion:~      Is effective, this program will contribute to the development of public policies for active~     and health lifestyle promotion among young population, especially from low- and middle-income~     countries. The main variables (intrapersonal, interpersonal and/or environmental stimulus)~     that help the young people to adopt an active lifestyle also may be indicated. Finally,~     investigators expect that the proposed strategies may be adaptable to the public school~     reality and they may be extended to the entire school system.~   "
86119|NCT02439814|"~     The cannabinoid delta 9-tetrahydrocannabinol (THC) is the primary psychoactive component of~     marijuana. THC is believed to be a significant factor in the addictive potential associated~     with marijuana use. In addition, attenuated levels of endogenous endocannabinoids have been~     found in alcohol-dependent individuals as compared to social drinkers, suggesting that~     changes in the sensitivity of the endogenous endocannabinoid system play a role in the~     transition from recreational drug use to substance use disorders. Thus, pharmacotherapies~     that target the cannabinoid system may be effective strategies for reducing marijuana use and~     dependence. Recent preclinical data demonstrate that the neurosteroid pregnenolone (PREG)~     inhibits THC activation of cannabinoid receptors and decreases symptoms of marijuana~     intoxication. In addition, other studies show that PREG inhibits drug-seeking behavior. This~     pilot study will provide important preliminary data on the effect of an acute dose of PREG on~     cue-related craving in individuals with cannabis use disorder.~   "
86120|NCT02439801|"~     Laparoscopic cholecystectomy is accepted as gold standard in the management of~     cholelithiasis. Although laparoscopic procedures have many advantages,intra-abdominal CO2~     insufflation can cause decreased lung volumes and compliance, increased airway resistance and~     impaired ventilation-perfusion ratio. In this study, investigators aim to investigate effects~     of intra-operative PEEP treatment at 3 distinct levels on respiratory dynamics and~     elimination time of volatile anesthetic agent.~   "
86121|NCT02439788|"~     This research study is for patients that have a cancer called Neuroblastoma that has either~     come back after treatment or did not respond to the standard medicines used to treat it. This~     study combines two different ways of fighting cancer: antibodies and Natural Killer T cells.~     Antibodies are types of proteins that protect the body from infectious diseases and possibly~     cancer. T cells, also called T lymphocytes, are special infection-fighting blood cells that~     can kill other cells, including cells infected with viruses and tumor cells. Both antibodies~     and T cells have been used to treat patients with cancers. The investigators have found from~     previous research that they can put a new gene into T cells that will make them recognize~     cancer cells and kill them. In a previous clinical trial, the investigators made a gene~     called a chimeric antigen receptor (CAR), from an antibody called 14g2a that recognizes GD2,~     a molecule found on almost all neuroblastoma cells (GD2-CAR). They put this gene into the~     patients' own T cells and gave them back to patients that had neuroblastoma. Nineteen~     patients were treated on that study and there were no long term side-effects seen after the~     GD2 T cell infusion. As the investigators have followed the patients over time, they noticed~     that for those patients with disease at the time of their infusion, the time to progression~     (the amount of time it takes before their neuroblastoma got worse) was longer in those whom~     they could find GD2 T cells in the blood for more than 6 weeks after the last T cell~     infusion. Because of this, the investigators think that if effector cells are able to last~     longer, they may have a better chance of killing neuroblastoma tumor cells.~      Natural Killer T cells are a special subset of innate lymphocytes that can effectively go~     into tumor tissues of neuroblastoma. Inside the tumor, there are certain white blood cells~     which help the cancer cells to grow and recover from injury. Natural Killer T-cells can~     specifically kill these cells. In this study, Natural Killer T cells will be genetically~     engineered to express GD2-CAR to attack neuroblastoma cells and the white blood cells inside~     the tumor tissue.~   "
86122|NCT02439775|"~     The purpose of this study is to obtain an assessment of the efficacy and safety of renal~     denervation in the presence of three standard antihypertensive medications.~   "
86123|NCT02439762|"~     The purpose of this study is to evaluate the impact of a Cognitive Behavioral Therapy (CBT)~     intervention compared to a Supportive Psycho-educational Control (SPC) condition in reducing~     the frequency and intensity of suicidal thoughts and behaviors in Veterans with Substance Use~     Disorders (SUDs) over a two-year follow-up period.~   "
86124|NCT02439749|"~     The purpose of this study is to obtain an assessment of the efficacy and safety of renal~     denervation in the absence of antihypertensive medications.~   "
86125|NCT02439736|"~     The primary objective of this study is to evaluate Ubiquitin C-terminal Hydrolase-L1 (UCH-L1)~     and Glial Fibrillary Acidic Protein (GFAP) biomarker levels in a population of CT-positive~     subjects (as determined by an independent Neuroimaging Review Committee) presenting acutely~     with traumatic brain injury (Glasgow Coma Scale score 9-15).~   "
86126|NCT02439723|"~     The FDA and Health Canada have approved regorafenib at a daily dose of 160mg for the~     treatment of metastatic colorectal cancer and gastrointestinal stromal cancer; however, the~     160 mg dose is not well tolerated by patients, especially women. The purpose of this study is~     to determine if lean body mass and acidity in the intestinal tract impact how regorafenib is~     absorbed into the bloodstream and then broken down and removed from the body. This may~     explain the side effects experienced at the 160 mg dose, especially by women, and inform~     regorafenib dosing in the future.~   "
86147|NCT02439450|"~     This study will test whether vaccination with viagenpumatucel-L combined with strategies to~     modulate the immune response is safe for patients with non-small cell lung adenocarcinoma who~     have failed at least one prior line of therapy for incurable or metastatic disease. These~     methods collectively use the body's immune system to target the patient's own tumor.~     Immunosuppression hinders that response, and may develop in NSCLC patients in a variety of~     ways, such as activation of checkpoint pathways in the tumor microenvironment. Drugs that~     disrupt checkpoint molecule signaling like anti-PD-1 monoclonal antibodies nivolumab, may~     release this brake on the immune system. Tumor expression of PD-L1 plays an important role in~     patient response to checkpoint inhibitors; in general, clinical response to checkpoint~     inhibitors requires tumor expression of PD-L1 and presence of Tumor Infiltrating Lymphocytes~     (TIL). Combining viagenpumatucel-L with anti-PD-1 agents may enhance the vaccine's anti-tumor~     activity while prolonging or increasing the efficacy of the checkpoint inhibitor.~   "
86127|NCT02439710|"~     The Patient Reported Outcomes, Burdens, and Experiences (PROBE) Study aims to develop a new~     global tool to enhance the direct patient-voice in health care decision-making. Government~     and private payers increasingly value data based on patient-centered outcomes research as~     part of the overall cost-benefit evaluation of high-cost care and treatment of diseases such~     as hemophilia. This emerging dimension of the healthcare environment presents a significant~     opportunity and urgent need to improve patient organizations' ability to collect and~     interpret relevant outcomes data. More robust patient reported data will improve advocacy~     efforts to build comprehensive care programs, promote home treatment and implement~     preventative treatment regimens thus allowing advocacy arguments to move beyond emotion and~     anecdote to those grounded in real-world patient experiences and evidence. With the support~     of the National Hemophilia Foundation, a global team of investigators will lead a patient~     focused research project to investigate and directly probe patient perspectives on outcomes~     they deem relevant to their care. Through PROBE, the investigators will develop and seek to~     validate the reliability, reproducibility and responsiveness of a low cost, easily~     administrable inventory for collecting patient self-reported outcomes, burdens and~     experiences in living with hemophilia. The investigators anticipate that the metrics~     established through PROBE will allow for comparison of patient outcomes within a country over~     time and cross-sectionally between countries (regionally and globally).~   "
86128|NCT02439697|"~     This is a prospective single-arm open-labeled cohort study on dialysis patients of the~     conversion from Aranesp® to NESP® for the treatment of anemia. The primary outcome of the~     study is the haemoglobin level after conversion to NESP® after 6 months. Secondary outcomes~     include the variability in haemoglobin level, average weekly dose of erythropoietin, safety~     profile of NESP®, patients' subjective assessment of fatigue and injection pain after the~     conversion.~   "
86129|NCT02439684|"~     This is a cross-sectional study that aims to assess the sensitivity and specificity of using~     HbA1c as a diagnostic test for detecting the presence of diabetes mellitus (DM) when compared~     to the use of oral glucose tolerance test (OGTT) among Hong Kong Chinese adult who have~     impaired fasting glucose (IFG).~      The investigators will recruit around 1000 non-diabetic adult participants who have impaired~     fasting glucose (i.e. fasting glucose level between 5.6 to 6.9mmol/L) AND without symptoms of~     hyperglycaemia to undergo both HbA1c test and oral glucose tolerance test after obtaining~     their informed consent. A diagnosis of DM is confirmed when both the fasting glucose level~     and 2-hour-post challenge plasma glucose level fall into diabetic range (i.e. fasting glucose~     level ≥7.0mmol/L and 2-hour-post challenge plasma glucose level ≥11.1mmol/L) after a standard~     75g OGTT. Participants with only 1 plasma glucose value within the diabetic range will be~     invited to repeat an oral glucose tolerance test for confirmation of their diagnosis as~     recommended by American Diabetes Association and World Health Organization. Demographic data~     of the participants including age, gender, smoking status, medical history, diet and activity~     level will be collected. Lipid profile, blood pressure, waist circumference and body mass~     index will be checked and the total cardiovascular risk in 10 years will be calculated for~     each participant using the Joint British Societies 2005 and Framingham 2008 equations to~     evaluate the baseline cardiovascular risk of the participants.~      These data will be analyzed using SPSS. The primary outcomes are the sensitivity and~     specificity of HbA1c in detecting diabetes mellitus diagnosed by oral glucose tolerance test~     (the gold standard). A receiver operating characteristic (ROC) curve will be obtained by~     plotting sensitivity against (1-specificity) for each cutoff value for identification of an~     optimal cutoff point. Diagnostic accuracy will be assessed by the area under the curve (AUC).~     The differences in characteristics among participants diagnosed to have diabetes mellitus by~     oral glucose tolerance test or HbA1c will be compared using independent t-test or χ2 test for~     comparison between the 2 groups.~   "
86130|NCT02439671|"~     This study investigates a service delivery model to better support young adults with autism~     spectrum disorders (ASD) in the transition from school to the community. The effectiveness of~     the McGill Transition Support Program, a small-group format intervention (meeting once a~     week for 2 hours over 10 weeks) focusing on communication, self-determination and working~     with others skills, is measured by multiple pre- and post-program-assessments in a staggered~     enrollment trial, a variant of a randomized controlled trial (RCT).~   "
86131|NCT02439658|"~     To assess the ability of common genetic variants in aggregate to predict drug-induced QT~     prolongation in patients being loaded with dofetilide or sotalol, and validate the~     feasibility of using a smartphone device for measuring QT interval.~   "
86132|NCT02439645|"~     This is a registry to examine genetic and clinical predictors of torsade de pointes events.~   "
86133|NCT02439632|"~     prulifloxacin is not inferior to levofloxacin hydrochloride in treating acute uncomplicated~     lower urinary tract infection in chinese~   "
86134|NCT02439619|"~     The aim of the project is to conduct a feasibility study of the mobile phone application~     TechCare for individuals with psychosis in the North West of England.~   "
86135|NCT02439606|"~     This prospective randomized trial evaluated Parker Flex-It stylet as an alternative to~     manufacturer, s GlideRite® Rigid Stylet to aid intubation with the GlideScope in patients~     undergoing elective non-cardiac surgery that required general anesthesia with orotracheal~     intubation.~   "
86136|NCT02439593|"~     This is a phase II randomized study of concurrent chemoradiotherapy and local hyperthermia~     (study group) versus chemoradiotherapy alone (control group) following neoadjuvant~     chemotherapy in locally advanced pancreatic cancer. Each of the treatment arm would have 39~     patients based on the expected overall 1 year survival advantage of +20% over the control~     group (p0=40%).~   "
86137|NCT02439580|"~     Annona muricata L., include the leaves, is found to contain biologically active Annonaceous~     acetogenins and plant polyphenols that are important components of human diet and a number of~     them are considered to have chemopreventive and therapeutic properties against cancer.~      To confirm previous findings in in vitro, animal study and traditionally use, a human, ex~     vivo and in vitro studies were conducted to evaluate the effects of consecutive ingestion of~     A. muricata leaves extract for eight weeks.~   "
86138|NCT02439567|"~     The purpose of this study is to evaluate the effects of sustained virological response in~     liver and spleen stiffness in patients with HCV compensated advanced chronic liver disease~     treated with new all oral antiviral drugs in order to determine factors implicated in~     stiffness change and its implications for long-term follow-up.~   "
86148|NCT02439437|"~     This study looks at whether a coping skills training program can help women manage pain and~     stress after breast surgery, and lower the risk of developing chronic pain. This coping~     skills program includes eight training sessions that are done by telephone. These sessions~     will focus on strategies for dealing with pain and stress, and how to apply these strategies~     to subjects' own experiences.~   "
86152|NCT02439385|"~     Oral curcumin-containing supplement will be given to colorectal cancer patients with~     unresectable metastases who will be starting Avastin/FOLFIRI chemotherapy for up to~     completion of (or withdrawal from) chemotherapy.~   "
86139|NCT02439554|"~     This subproject is included in a project coordinated between program groups Evaluation of~     Health Services of Epidemiology and Public Health (Project CAMISS). The overall objective is~     to evaluate different aspects of health care received by patients with breast cancer from the~     diagnostic process, treatment, complications, survival and quality of life, to provide~     information to improve the effectiveness of interventions, reduce variability, have best~     predictive rules and increase the quality of life. The main objective of the subproject is to~     create and validate prospectively predictive rules of recurrence, complications, mortality,~     changes in quality of life in these patients at admission and one/two years of treatment and~     to evaluate the external validity of our rules to predict relapses, complications and~     mortality in the retrospective sample of patients participating in screening programs.~     Observational methodology with information available from a retrospective cohort of women~     diagnosed between 2000 and 2009 and another 2-year prospective follow-up included 2040~     incident cases of breast cancer in 18 hospitals of 5 regions. Cohorts will learn clinical and~     health care diagnosis, tumor, treatment, hospital, follow-up (complications, relapse, and~     vital status) cost and quality of life. Prediction rules are created by means of~     regression/Cox models at the prospective sample and also investigators will assess the~     external validity in the retrospective cohort in the case of recurrence, complications and~     mortality. Expected results: There are currently no results of cohort analysis of the~     diagnostic process of care that integrates different aspects. The study will create tools to~     assist prognostic and therapeutic decision making process in these patients~   "
86140|NCT02439541|"~     Phase I-II Clinical Trial-Safety and efficacy of umbilical cord derived mesenchymal stem~     cells (UC-MSCs) in patients with chronic heart ischemia cohort and perspective study.~   "
86141|NCT02439528|"~     The combined pulmonary fibrosis and emphysema syndrome (CPFE) individualized by our group in~     2005 is characterized by an often severe dyspnea, almost exclusive male predominance, and~     often major, profound impairment of gas exchange contrasting with preserved lung volumes and~     absence of airflow obstruction, and a high risk of pre-capillary pulmonary hypertension~     responsible for increased mortality. Almost all patients are smokers or ex-smokers. There are~     some arguments in favor of genetic abnormalities in this syndrome of unknown etiology (other~     than smoking) including short telomeres and mutations in the telomerase complex genes. There~     are also emphysematous lesions, in patients with familial pulmonary fibrosis, with mutations~     in the SFTPC gene (surfactant protein C), and reported cases of CPFE syndrome with SFTPC~     mutation. No large genetic studies have been conducted to date in the CPFE syndrome. Our main~     hypothesis is that the proportion of subjects with short telomeres is higher among patients~     with CPFE syndrome than in subjects of similar age with idiopathic pulmonary fibrosis but~     without emphysema. It has previously been shown that mutations in the telomerase TERT or TERC~     genes are mostly found in people whose telomeres are abnormally short. The investigators~     propose to use that test to identify patients most likely carrying a mutation, and to seek,~     among them, the mutations in the TERT or TERC telomerase genes. The objective of the study is~     to compare the proportion of patients with short telomeres in the group of patients with CPFE~     syndrome to that of other patients (with idiopathic pulmonary fibrosis without emphysema, or~     with emphysema without fibrosis).~   "
86142|NCT02439515|"~     The study proposes a novel rehabilitative program for the recovery of locomotor abilities in~     post-acute stroke patients. The hypothesis is that a rehabilitative program which involves a~     biofeedback cycling training combining voluntary effort and Functional Electrical Stimulation~     (FES) of the leg muscles, and a biofeedback balance training is superior to usual care in~     improving walking abilities, disability, motor performance, and independence of post-acute~     stroke patients. The innovative approach is to investigate whether interventions which do not~     directly involve locomotor functions but movements similar in terms of kinematic patterns and~     neural commands (e.g. pedaling), or aimed at recovering an essential prerequisite for~     walking, such as postural control during upright stance, may improve and/or accelerate the~     recovery of walking abilities.~      A single-blind randomized controlled study is carried out. Participants are post-acute stroke~     patients experiencing a first stroke less than 6 months before recruitment, with an adult~     age, a low level of spasticity of the leg muscles (Modified Ashworth scale <2), no~     limitations at hip, knee, and ankle joints, and able to sit up to 30 minutes. Subjects are~     randomized to one of two groups, one performing the novel rehabilitative program in addition~     to usual care (experimental group), and one performing usual care alone (control group).~      The experimental program consists of 15 sessions of FES-supported voluntary cycling training~     followed by 15 sessions of balance training. Both cycling and balance training are supported~     by a visual biofeedback in order to maximize patients' involvement in the exercise and are~     performed in addition to usual care.~      The control group is involved in standard physical therapy which includes stretching,~     muscular conditioning, exercises for trunk control, standing, and walking training, and upper~     limb rehabilitation.~      Both training programs last 6 weeks and patients are trained daily for about 90 minutes.~     Cycling and balance training last about 20 minutes; thus, patients in the experimental group~     perform only about 70 minutes of usual care.~      Participants are evaluated at baseline (T1), after the end of the cycling training or after 3~     weeks of usual care (post-treatment, T2), after the end of the whole intervention~     (post-treatment, T3), and about 6 months after the end of the intervention (follow-up, T4).~   "
86143|NCT02439502|"~     The intent of this study is to evaluate the performance and usability of Fuse in routine~     practice. The participants are indicated for upper (gastroscopy) and lower (colonoscopy)~     gastrointestinal endoscopy procedures. The study is open label, prospective and Post~     Marketing study.~   "
86144|NCT02439489|"~     PI3K signaling is a hallmark of many cancers. Subsets of cancers become dependent on PI3K~     pathway signaling as a result of mutations of the PIK3CA gene itself or of regulators of PI3K~     (e.g. PTEN, HER2). As a consequence, pathway mutated tumors are particularly sensitive~     towards PI3K-pathway inhibition. BKM120 is a potent and highly specific oral pan-class I~     PI3K-inhibitor.~      The study FM-11-F01b is a phase Ib single institution study using the combination of BKM120~     and cisplatin or carboplatin in patient with pathologically confirmed recurrent or metastatic~     advanced solid tumor, for which treatment with a platinum agent is indicated (preferentially~     head and neck, NSCLC, ovary, endometrial).~      The primary objective of the study is to define the phase II recommended dose of daily oral~     BKM120 and cisplatin (Group 1) or carboplatin (Group 2), given intravenously (IV) on day 1~     every 3 weeks.~   "
86145|NCT02439476|"~     Multiple myeloma (MM) is an incurable disease that is characterized by the accumulation of~     clonal plasma cells in the bone marrow. While MM patients with relapsed disease may achieve~     responses to subsequent antimyeloma therapies, the duration of response decreases with~     successive relapses until resistant disease develops. Until recently, the median survival~     following relapse after induction therapy was approximately one year. The relatively recent~     US Food and Drug Administration (FDA) approvals of bortezomib (2003) and combination~     lenalidomide plus dexamethasone (2006) therapies for the treatment of previously treated MM~     has provided effective therapeutic options that give patients with relapsed or refractory MM~     the prospect for a prolongation of overall and progression-free survival times. However, MM~     remains an incurable disease. A clear unmet medical need still exists for additional novel~     therapeutic options for the treatment of previously treated MM.~      Plerixafor reversibly inhibits CXCR4 binding to stromal cell derived factor (SDF)-1alpha and~     was recently discovered to be an effective agent to mobilize CD34+ cells into the peripheral~     blood. In normal volunteers, administering Plerixafor after 4-5 days of G-CSF resulted in a~     3-3.5 fold increase in circulating CD34+ cells. Two phases 3 studies demonstrated that the~     combination of G-CSF and Plerixafor is superior to G-CSF alone for mobilizing hematopoietic~     progenitor cells in front-line or as salvage therapy in patients with multiple myeloma.~      Nevertheless, almost all patients ultimately relapse, and no plateau is observed in the~     survival curves. At the time of disease recurrence, there is not one standard salvage~     approach, but instead, various therapeutic options are available, including novel~     agents-based therapy, administered for a fixed duration of time or until progression. In the~     pivotal trial for the approval of bortezomib as monotherapy in relapsed and refractory MM,~     the median PFS was 7 months, whereas in the pivotal trials for the approval of lenalidomide~     in combination with dexamethasone in the same group of patients, the median time to~     progression was approximately 11 months. A more recent prospective, randomized, phase 3 study~     has shown that a triplet combination of bortezomib, thalidomide and dexamethasone (VTD)~     achieved superior results compared to thalidomide dexamethasone (TD) alone in patients~     relapsing following ASCT, with a median time to progression of 19.5 versus 13.8 months,~     respectively. This study suggests that combinations consisting of both an IMiD and a~     proteasome inhibitor are a valuable option at the time of relapse.~      However, when a frozen graft is available, it is also possible to repeat high-dose therapy in~     patients who previously responded to the frontline application of high-dose melphalan and~     ASCT. Over time, several reports have demonstrated the feasibility of this salvage strategy.~     The majority of data are available from retrospective studies and are based on single-centre~     experiences with small numbers of selected patients. In this setting, PFS has been shown to~     range from 7 to 22 months, and the treatment-related mortality (TRM) was acceptable, ranging~     from 0 to 8%. Various prognostic factors for prolonged PFS have been described, such as the~     duration of response to the first high-dose therapy, or the number of lines of therapy prior~     to salvage ASCT.~      With this background, this prospective non-interventional multicentre study will aim to~     collect data on the feasibility of salvage ASCT using a Plerixafor-based stem cell~     mobilization in relapsed MM, according to Plerixafor label in France.~      This is a non-interventional study; visit will be performed as usual, according to each~     center practices. No additional visits will be requested for the study purpose. The date for~     each visit and any data generated must be recorded on the appropriate eCRF.~      The study will consist of 3 periods:~        -  An early screening period~        -  Autologous stem cell mobilization period~        -  High dose melphalan therapy and autologous graft infusion and follow-up for12 months~          after salvage ASCT Inclusion visit~      This visit may occur up to 28 days before Mozobil® administration. This visit will be~     performed during the visit of pre-transplant assessment. For the pre-transplant assessment,~     the procedures are performed routinely before ASCT even if the patient is not included in the~     study:~      Stem cell mobilization phase The stem cell mobilization phase is performed according to~     standard practice of each participating centre.~      Follow-up visits High dose melphalan administration and autologous graft infusion will be~     performed according to each centre standard practice. Patients will be followed according to~     each center practices. The follow-up of this non-interventional study will end 12 months~     after ASCT.~      Subjects will be enrolled over a 2 years period. The total duration of the study will be 36~     months~   "
86146|NCT02439463|"~     The present study assesses the health-related quality of life and the locomotor capabilities~     major traumatic lower limb amputees who use prosthesis.~   "
86149|NCT02439424|"~     Recent advancements with implantable cardiac device technology include extensive diagnostic~     and therapeutic algorithms for prevention as well as termination of atrial tachyarrhythmias~     (ATA). Preventive atrial pacing (PAP) and a novel atrial antitachycardia pacing algorithm~     (Reactive ATP™) in conjunction with managed ventricular pacing (MVP) recently has been shown~     to reduce progression to permanent atrial fibrillation (AF) in pacemaker patients with intact~     atriovenous (AV) conduction and a history of ATA. Whether the use of Reactive ATP™ for~     reducing AF burden extends to patients with an implantable cardioverter defibrillator (ICD),~     who typically have structural heart disease and heart hailure (HF), is unknown.~   "
86156|NCT02439333|"~     The main oxygen therapy to the patients with acute exacerbation of Chronic obstructive~     pulmonary disease, who are mild to moderate respiratory insufficiency (arterial blood gas~     analysis showed pH = 7.35, PO2 < 60mmHg,PaCO2＞45mmHg) or have achieved the traditional~     noninvasive ventilation support standard but can not tolerate or reject, was nasal catheter,~     venturi mask and other conventional oxygen therapy. All these inaccurate inhaled oxygen~     concentration methods with inadequate heating and humidifying lead to poor patient tolerance~     and adverse reactions such as airway secretions discharge disorders. The high flow nasal~     respiratory therapy (Nasal high flow, NHF) utilises higher gas flow rates than conventional~     low-flow oxygen systems. The devices used deliver heated and humidified oxygen at a flow of~     up to 60 litres per minute via nasal cannulas with low level continous positive airway~     pressure. This study is a prospective randomized study. AECOPD patients with no severe~     respiratory failure are treated with NHF and conventional oxygen therapy respectively. The~     target is that NHF can increase the comfort degree of patients,reduce the rate of~     endotracheal intubation, and shorten the time of hospitalization.~   "
86157|NCT02439320|"~     This is a prospective randomized, double-blind, placebo-controlled study in subjects with~     disabling migraine (Migraine Disability Assessment (MIDAS) score ≥ 11).~   "
86158|NCT02439307|"~     A total of 46 patients diagnosed with liver cirrhosis will be recruited. All patients will be~     evaluated with five psychometric tests and critical flicker frequency to diagnosis minimal~     hepatic encephalopathy (MHE). A breath test sample will be performed in all patients with MHE~     with 10 g of lactulose to establish the diagnosis of small intestinal bacterial overgrowth~     (SIBO). Patients diagnosed with EHM and SIBO will be randomized to receive per day 1200 mg of~     rifaximin (group A) or placebo (group B) for 2 weeks. A complete medical history, nutritional~     assessment, biochemical studies, and evaluation of quality of life will be performed in all~     patients included in the study. Besides the initial visit, patients will receive subsequent~     care 2, 4, 8, 12, and 24 weeks after the beginning of the study.~   "
86159|NCT02439294|"~     Coronary artery disease is a common and serious disease, the leading cause of death~     worldwide. Obstructive sleep apnea syndrome (OSAS) is common and often under-diagnosed in~     coronary artery disease where it could be involved in the pathophysiology and perhaps~     prognosis. The entanglement of the two pathologies is actually quite well known, in~     particular the consequences of one over the other just beginning to be studied. Understanding~     the pathophysiology through new imaging modalities should improve the management of patients~     to propose new approaches.~      SAS-IDM is an interventional and prospective study conducted at the University Hospital of~     Montpellier. Patients will be divided in three groups depending of the results of the~     polysomnography: 1/ AHI < 5/h: normal, without OSA ; 2/ 5/h ≤ AHI < 30/h: mild or moderate~     OSA ; 3/ IAH ≥ 30/h: severe OSA. A treatment by CPAP will be proposed to patients of the~     group severe OSA.~   "
86160|NCT02439281|"~     Background: Millions of pediatric patients undergo laparoscopic surgeries every year and many~     of them suffer significant pain and anxiety. Patient's anxiety correlates with the severity~     of pain and effective postoperative analgesia is necessary for optimal recovery. Single~     injections ultrasound guided rectus sheath blocks provide satisfactory postoperative~     analgesia after pediatric laparoscopic appendectomy, however they are short lived. Searching~     for a blocking agent that last long enough to outlast pain and has minimal side effects is a~     difficult task. Using a combination of drugs yielded mixed results. Few pediatric studies~     showed at best a weak trend in favor of clonidine prolonging analgesia after some blocks, but~     anxiolytic properties of clonidine were not investigated. This study will compare rectus~     sheath ropivacaine blocks with ropivacaine and clonidine blocks.~      Methods: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic~     appendectomy will be double blinded and randomized to the two treatment groups: the~     Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilaterally in the posterior~     rectus sheath, at the umbilicus location, and Ropivacaine Clonidine Group will receive~     ropivacaine 0.5% (10 ml) and clonidine (2mcg/kg). Post-operative analgesia will be provided~     with ketorolac and acetaminophen around the clock, and morphine, or/and oxycodone as needed.~     The primary aim is to determine if ropivacaine combined with clonidine prolongs duration of~     paresthesia. The secondary aims are to determine if the use of clonidine decreases anxiety~     level, prolongs duration of analgesia, and decreases pain severity at umbilicus laparoscopic~     site, reduces the need for analgesics, improves satisfaction with pain control, and is~     associated with complications such as oversedation, hypotension, and bradycardia.~      Conclusions: Every hour of excellent analgesia count and a prolongation of block duration by~     at least 50% is clinical relevant. The investigators hypothesize that rectus sheath~     injections with ropivacaine and clonidine offer improved pain management compared to~     ropivacaine alone.~   "
86161|NCT02439255|"~     This randomized clinical trial studies the effects of black raspberry compounds~     (phytochemicals) on the bacteria in the mouth (oral microbiome) of current smokers and~     non-smokers. The oral microbiome protects the body from pathogenic bacteria. Smoking alters~     the oral microbiome and may increase the susceptibility to cancer by modulating normal~     host-bacteria interactions. Black raspberry phytochemicals may protect the oral microbiome of~     smokers and may lower their risk of developing oral cancer.~   "
86162|NCT02439242|"~     In high perioperative risk patients, guidelines suggest intraoperative haemodynamic~     optimization by measurement of stroke volume (SV) to guide fluid resucitation.This strategy~     requires an invasive monitoring and learning. Some studies tried to find SV surrogates based~     on haemodynamic usual parameters. In an experimental hemorrhagic shock, SV was correlated to~     the pulse pressure (PP) / heart rate (HR) ratio.~      The investigators hypothesized that SV variations (ΔSV) would be correlated to the PP/HR~     ratio variations (ΔPP / HR) during fluid challenge, and ΔPP / HR would be able to detect a~     ΔSV greater than 10%.~   "
86163|NCT02439229|"~     The Vitamin D and fetal bone length study:~      Vitamin D and its association to bone length in midterm pregnancy.~   "
86164|NCT02439216|"~     The MoveDMD study is a 3-part, Phase 1/2, multi-site study to evaluate the safety, efficacy,~     pharmacokinetics (PK) and pharmacodynamics (PD) of edasalonexent (also known as CAT-1004) in~     pediatric patients with a genetically confirmed diagnosis of DMD. Male patients from ≥4 to <8~     years of age will be enrolled.~      Edasalonexent is an orally administered small molecule targeted to inhibit activated NF-κB, a~     molecule that is activated from infancy in DMD and which is central to causing muscle damage~     and preventing muscle regeneration. Data on magnetic resonance imaging of the lower and upper~     leg muscles, physical function (including timed function tests) and muscle strength will be~     studied.~   "
86165|NCT02439203|"~     The purpose of a randomized, double-blind, placebo-controlled, 2-way crossover study is to~     evaluate the efficacy, safety/tolerability and pharmacokinetics of JM-010 for the treatment~     of subjects with Parkinson's Disease (PD) with levodopa-induced dyskinesia (LID).~   "
86166|NCT02439190|"~     The purpose of this study is to determine whether BMS-986120, aspirin, or aspirin and~     clopidogrel decrease blood clotting.~   "
86167|NCT02439177|"~     The aim of this study is to determine the System Accuracy and User Performance evaluation of~     the mentioned BGM systems by gaining a sufficient amount of measured data from capillary~     blood.~   "
86168|NCT02439164|"~     Sedation in the operating room, the Post Anesthesia Care Unit and the Intensive Care Unit is~     common and often necessary for patients with intracranial brain tumor. Repeated neurological~     function assessments is needed in those locations, especially in patients with tumors in or~     near eloquent regions, this is to monitor their neurologic performance to determine if there~     are alterations that require treatment. Some slowly infiltrative low-grade gliomas near~     eloquent regions do not show any detectable neurologic deficits, perhaps from reorganization,~     but with sedation by some sedatives such as benzodiazepine midazolam and anesthetic hypnotic~     propofol, the disease may seem much worse resulting in inappropriately aggressive treatment.~     This may be especially problematic in patients undergoing awake craniotomy for tumors in~     eloquent regions.~      This is a single-center perspective study. Patients will be mildly sedated to keep them~     responsive and cooperative. Motor and sensory function will be evaluated before and after~     mild sedation. Specific benzodiazepine antagonist will be used if sedated by midazolam.~      The purpose of this study is to observe if commonly used benzodiazepine midazolam exacerbates~     or unmasks motor and sensory function in patients with intracranial eloquent area gliomas.~      Hypothesis:~      mild sedation can unmasks or exacerbate motor and sensory deficits in patients with eloquent~     area glioma but not in non-neurosurgical patients/healthy volunteers. If the neurologic~     deficits induced by benzodiazepine agonist, then can be reversed by flumazenil.~   "
86169|NCT02439151|"~     Extracorporeal membrane oxygenation (ECMO) has been widely used in patients with severe acute~     respiratory distress syndrome (ARDS). But how to choose mechanical ventilation strategy is~     still not clear for severe ARDS patients supported by ECMO. Our previous work found that,~     compared to the traditional lung rest strategy, transpulmonary pressure guide new lung~     ventilation strategy can better maintain lung volume reduction lung collapse, atelectasis~     occurs. The severe ARDS patients receiving ECMO therapy were randomized divided into a new~     ventilation strategy group and the conventional ventilation strategy group. The new~     ventilation strategy is transpulmonary pressure guide ventilator setting method, and the~     conventional ventilation strategy is Extracorporeal Life Support Organization (ELSO) guide~     ventilation method. Compare the difference between the two groups of patients in lung injury,~     and explore the lung protection mechanism of new lung ventilation strategies guided by~     transpulmonary pressure. Our research group considered that transpulmonary pressure guide new~     lung ventilation strategy can provide more effective lung protection. And it will be further~     used in clinical work.~   "
86170|NCT02439138|"~     This research study is evaluating a drug called idelalisib (formerly known as GS-1101 or~     CAL-101) as a possible treatment for Waldenstrom's Macroglobulinemia (WM).~   "
86171|NCT02439125|"~     The purpose of this study is to evaluate the safety, tolerability and efficacy of eltoprazine~     to treat levodopa-induced dyskinesia in patients with Parkinson's disease~   "
86172|NCT02439112|"~     The overall aim is to examine whether early initiated, individualized exercise training in~     patients newly diagnosed with multiple myeloma, irrespective of age and current performance~     status, will be beneficial for the patients´physical function, level of physical activity and~     quality of life, pain and bone disease.~      The investigators will examine the effect of supervised in-hospital exercise training~     sessions combined with home-based exercise training, initiated at time of diagnosis. The~     outcomes of interest are physical function, level of physical activity, QOL, pain and bone~     disease.~      Furthermore, to describe the disease in patients with newly diagnosed MM in relation to~     physical function, level of physical activity, QOL, pain and bone condition at time of~     diagnosis.~      The investigators hypotheses are:~        -  Individualized exercise starting at time of diagnosis will have positive effects on~          physical function, physical activity, QOL and pain.~        -  Individualized exercise starting at time of diagnosis will have positive effects on bone~          disease (bone markers), bone mineral density (BMD) and lean body mass.~        -  A higher level of physical function is associated with a higher level of physical~          activity, less pain, better QOL, and higher BMD and lean body mass.~   "
86173|NCT02439099|"~     It is hypothesized, that local retinoic acid (RA) homeostasis is functionally involved in the~     pathophysiology of depression. In a cross-sectional (and partly longitudinal) analysis, serum~     RA status will be assessed in healthy controls and subjects with Major Depression,~     Alzheimer's disease, alcoholism and in subjects with schizophrenia.~   "
86174|NCT02439086|"~     The purpose of this study is to determine whether 18F-FDG-PET-CT and texture analysis of MRI~     performed 9 weeks after Neoadjuvant Chemo-radiotherapy in patients with locally advanced~     rectal cancer has the ability to identify patients with Complete Response.~   "
86175|NCT02439073|"~     Purpose The purpose of the PROLUCA study is to investigate the efficacy of early~     postoperative rehabilitation in a non-hospital setting in patients with operable lung cancer,~     with focus on exercise training.~      Design/Methods~      One hundred and twenty-eight (n=128) participants (64 patients/study arm) with Non-Small Cell~     Lung Cancer (NSCLC), stage I-IIIa, referred for surgery, will be randomized to one of the~     following two groups:~        1. Early postoperative rehabilitation initiated as early as two weeks after surgery~        2. Postoperative rehabilitation initiated 14 weeks after surgery Intervention The~          intervention consists of a supervised group exercise program comprising resistance and~          cardiorespiratory exercise two hours weekly for 12 weeks combined with individual~          counseling.~      The primary study endpoint is Maximal oxygen uptake measured by a VO2peak test (direct~     measurement) Secondary endpoints include: Six minutes walk distance (6MWD),~     One-repetition-maximum (1RM) Patient-reported outcomes (PROs) on health related quality of~     life, fatigue, depression, lifestyle, postoperative complications, hospitalization time, sick~     leave, work status and survival.~      Results The results of PROLUCA will identify the optimal timing of postoperative~     rehabilitation in NSCLC patients with focus on increasing physical capacity and health~     related quality of life and reducing the side effects from the treatment of the cancer~     disease.~   "
86176|NCT02439060|"~     This randomized phase III trial studies how well biologic mesh works in preventing parastomal~     hernia in patients with bladder cancer who are undergoing radical cystectomy, or removal of~     the bladder, and ileal conduit diversion. An ileal conduit is a tube created from your small~     intestine that will be used as a tube for urine to flow out of your body. Parastomal hernia~     is a type of hernia that can occur in the stomach area where the ileal conduit is placed.~     Biologic mesh may help prevent parastomal hernia following surgery and ileal conduit~     diversion.~   "
86177|NCT02439047|"~     The objective of this study, which will be realised in vitro on human samples, is to test 2~     cell sources isolated from peritoneum for adult mesothelial cells (peritoneal samples) and~     from adipose tissue for the adipose stem cells (adipose tissue samples). The latter will be~     differentiated towards the mesothelial phenotype and morphotype. The 2 routes will be~     compared and the most satisfactory one will be chosen to make a non-stick patch.~   "
86178|NCT02439034|"~     The results of the study will permit to set up a standardized and validated procedure of pain~     management authorizing medical and paramedical staff of brachytherapy department to handle~     pain and in this way to improve the quality of life of the patients.~   "
86179|NCT02439021|"~     The Laryngeal Mask Airway (LMA) has been used widely for different patients and found to be~     highly safe for adult and pediatric patients. However, the LMA has some limitations and~     weaknesses (e.g. more insertion attempts in 5% to 10 % of all cases. Despite the easy~     insertion of the LMA, it is crucial to check correct placement of the LMA airway.~   "
86180|NCT02439008|"~     This study will follow-up immune cell populations, secreted factors and released nanovesicles~     in the blood before, during and after high dose radiation therapy which should give new~     information of the efficacy of the hypofractionated high dose radiation therapy and a~     rationale for adjuvant immunotherapy.~   "
86181|NCT02438995|"~     This is an open-label, non-randomized, two arm, Phase I research study of superselective~     intraarterial Cetuximab (Erbitux) with or without radiation therapy for treatment of~     recurrent unresectable squamous cell carcinoma of the head and neck (HNSCC).~   "
86182|NCT02438982|"~     Nephrotic syndrome in children is primarily caused by minimal change disease. Majority of~     these patients respond well to corticosteroids. However, as many as 70% of children with~     nephrotic syndrome experience at least one relapse, and 30% develop a more complicated course~     with frequent relapses (FRNS)(≥2 relapses/ 6 months) with or without steroid dependency~     (SDNS)(relapse during tapering or within 2 weeks after discontinuation of corticosteroids).~     Repeated and prolonged courses of steroids in these children often result in long-term~     complications. The goal of the treatment is to reduce the rate of relapses, the cumulative~     dose of corticosteroids, and the incidence of serious complications. In order to minimize the~     side effects of steroid therapy, different steroid sparing agents such as cyclophosphamide,~     calcineurin inhibitors(CNI), levamisole, and mycophenolate mofetil (MMF) have been used in~     SDNS. Whereas CNI are usually considered the steroid sparing drug class of first choice,~     rituximab is increasingly used as alternative to minimize CNI toxicity. Various prospective~     studies suggest that Rituximab, a B cell depleting monoclonal antibody, could be a safe and~     effective alternative to steroid or immunosuppressants to achieve and maintain remission in~     this population.Single rituximab course have been shown to be efficacious for 6 to 12 months~     and the side effect profile observed to date is very benign. Studies comparing the usefulness~     of these agents are lacking. In our proposed randomized controlled trial, the investigators~     want to compare the efficacy and safety of CNI to that of Rituximab in treating children with~     SDNS.~   "
86183|NCT02438969|"~     Background:~      - Researchers want to learn if people with alcohol dependence have more difficulty learning~     to feel calm, or learn to fear things more easily. They also want to study how early life~     stress (ELS) affects the ability to learn to feel calm.~      Objective:~      - To see if people with alcohol dependence and/or ELS have a harder time learning to feel~     calm than people without these. Also, to see if DNA is changed by ELS and if this change~     affects fear conditioning and extinction.~      Eligibility:~        -  Adults ages 21-65 with and without an alcohol use disorder (AUD) and with and without~          ELS.~        -  Healthy volunteers.~      Design:~        -  Participants will be screened with:~             -  Medical history~             -  Physical exam~             -  Blood and urine tests~             -  Psychological tests~             -  Treatment for symptoms of alcohol withdrawal, if needed~        -  Healthy volunteers will have 1 overnight visit (2 days, 1 night). AUD participants will~          stay at the clinic for about 4 weeks.~        -  Participants will:~             -  Rate alcohol use/craving, depression, anxiety, and childhood trauma.~             -  Have psychophysiological measures: electrodes and mild electric shock.~        -  Have a functional magnetic resonance imaging (MRI) scan. Participants will lie on a~          table in a metal cylinder with a coil over their head. In the first scanning session,~          they will see pictures, do a simple task, and may get shocks. Participants will also do~          a second scanning session in which they will perform the aforementioned fear~          conditioning and extinction task, as well as a facial expression matching task, an~          affective word processing task, and a task measuring valuation of monetary rewards.~             -  Answer questions about their emotions (some participants).~             -  Have blood drawn from an arm vein or intravenous (IV) line.~             -  AUD participants will get a dexamethasone pill. The next day, they will get a~               hormone injected in and have blood drawn from an IV line.~        -  AUD participants will have 3 follow-up visits with questions and blood and lab tests.~   "
86184|NCT02438956|"~     A randomized, double blind placebo-controlled parallel intervention in adults over the age of~     50 will be performed. Participants will receive a supplement capsule containing placebo~     (Crystalline Cellulose) or 500mg of Setria® Glutathione to eat for 120 days. Glutathione is~     hypothesized to replenish the body's reserves that may be depleted through natural aging~     process, poor diet, or due to the detoxification process for drugs. The primary end point is~     the number of healthy days experienced during the duration of the study. Secondary endpoints~     include cellular and biochemical measures from blood samples taken before and after the~     study.~   "
86185|NCT02438943|"~     To assess the effectiveness of a clinical audit and physician based intervention in improving~     the management of dyslipidemia at Health centres in the Southeast Health Region of Jamaica~   "
86186|NCT02438930|"~     This study pilot tests and intervention to help individuals reduce their risk for acquiring~     or transmitting HIV. The intervention is implemented when people are tested for HIV in an~     outpatient clinic in rural Uganda. Approximately half of participants will receive the~     intervention and the other half will receive the usual counseling provided during HIV~     counseling and testing.~   "
86200|NCT02438748|"~     The main objective of this study is to determine whether biological stress markers (Oxidized~     Phosphatidylcholines) in the blood can be used to predict the efficacy of rTMS in the~     treatment of major depressive disorder (MDD). It is our goal to identify biomarkers that may~     be used to determine which patients will benefit from rTMS treatment. A second objective of~     this study is to measure any changes in stress markers that occur across the course of rTMS~     therapy.~   "
86201|NCT02438735|"~     Prior studies have shown surgical excision of endometriomas are associated with a decline in~     ovarian reserve as assessed by serum anti-Mullerian Hormone (AMH) levels. However, the~     natural history of serum AMH levels in the presence of untreated endometriomas are unknown.~     Purpose of this study is to determine whether the presence of endometriomas cause a faster~     decline in serum AMH levels than in healthy women over a six months period.~   "
86458|NCT02435381|"~     The purpose of this study is to determine the effects of treatment with carisbamate compared~     to treatment with placebo, on alcohol-induced stimulant and subjective effects in~     non-treatment seeking alcohol-dependent human volunteers.~   "
86187|NCT02438917|"~     Chronic liver injury leads to the accumulation of proteins in the liver that form dense~     scars. Liver scar formation is typically a slow process that leads to major organ damage and~     loss of function over the course of many years. During scar formation the extracellular~     matrix in the liver changes. The type and quantity of extracellular collagen and other~     proteins change during tissue remodeling. Some of these changes can be detected by analyzing~     factors present in blood. Because of the lengthy time course, changes in the rate of liver~     scar formation and regression are very difficult measure; however, accurate measurements are~     needed in order to conduct trials of interventions aimed at preventing scar formation and/or~     promotion scar regression. Current methods have sub-optimal specificity and selectivity. The~     long term objective of the study is to identify serum proteins that can be used to accurately~     estimate rates of liver fibrosis progression and regression. The project focusses on a novel~     methodology that uses stable isotope labeling with deuterated water, D2O, to tag~     newly-synthesized proteins. Mass spectroscopy is used to identify individual proteins and to~     quantify the ratio of labeled protein to total protein. This ratio provides information about~     the rate of synthesis of the protein of interest. This method will be applied to specimens~     from patients with hepatitis C virus (HCV) infection who are about to begin HCV treatment.~     Treatment is known to reduce liver inflammation and collagen content.~   "
86188|NCT02438904|"~     Objectives:~      Primary Objective~      To provide compassionate access to the Miltenyi device for CD34+ cell infusions to patients~     who experience poor graft function after stem cell transplantation (SCT).~   "
86189|NCT02438891|"~     Most tinnitus sufferers experiences significant anxiety or depression that worsens the~     subjective symptoms related to tinnitus. In this study, we intend to use internet-based~     cognitive behavioral therapy (CBT) in addition to sound therapy to provide psychotherapy to~     patients with tinnitus. Multiple research studies have found CBT to be effective in improving~     the subjective symptoms of tinnitus. The internet-based CBT course developed for this study~     is 8 weeks in duration and organized into eight 1-week modules; each module contains 2-4~     separate lessons and homework assignments. Patients will be given unique usernames and~     passwords. In each weekly module, patients will review educational materials online, do~     exercises. and will be given feedback based on the results of the completed exercises. In~     addition, patients are given different meditation exercises each week for relaxation and~     coping with their tinnitus. These interactive materials enable patients to manage and control~     any negative feelings and thoughts that may be associated with tinnitus and help take their~     attention away from tinnitus. Tinnitus loudness and annoyance will be measured before and~     after the program. An internet-based course enables care providers to monitor patients'~     progress with the CBT course remotely, and allows patients to learn CBT at their own~     convenience and schedule.~   "
86190|NCT02438878|"~     The primary objective of this project is to evaluate the impact on infant growth and~     infant-feeding practices of a low-cost series of video trainings and tools targeted to~     medical staff and designed to support ongoing Baby Behavior education of WIC participants.~   "
86191|NCT02438865|"~     This clinical trial is designed to compare the effect of single postoperative intravesical~     chemotherapy instillation versus maintenance therapy on reducing bladder cancer recurrence~     after surgery for UTUC.~   "
86192|NCT02438852|"~     This randomized phase IV trial studies how well the continuous infusion of ropivacaine~     hydrochloride works in reducing pain after surgery in patients with bladder cancer.~     Ropivacaine hydrochloride is an anesthetic drug used to decrease pain by numbing an area of~     the body without putting the patient to sleep. Continuous infusion of ropivacaine~     hydrochloride may reduce pain and improve the quality of life for patients after bladder~     surgery.~   "
86193|NCT02438839|"~     The aim of the present study is to investigate whether curative chemoradiation of low rectal~     cancer is feasible, safe and effective in a multicenter study with results comparable to~     those of single center studies.~      Results from previous studies indicate that a considerable fraction of patients with low~     rectal cancer can be cured by a combination of radiation and chemotherapy alone and thus be~     spared from operation.~   "
86194|NCT02438826|"~     The main purpose of this study is to evaluate the efficacy of the study drug known as~     LY2951742 in participants with chronic cluster headache.~   "
86195|NCT02438813|"~     The primary objective of this registry is to develop a comprehensive understanding of the~     condition of submental (SM) fullness due to submental fat (SMF), how it is treated in current~     clinical practice, and the risks and benefits associated with its treatment.~   "
86196|NCT02438800|"~     This is a randomized clinical trial to evaluate if the addition of long-acting reversible~     contraception (LARC) focused video-counseling during prenatal care increases uptake of~     postpartum LARC.~   "
86197|NCT02438787|"~     The purpose of this study is to assess the efficacy of ustekinumab, in adult anti-TNF(alpha)~     refractory participants with active radiographic axial spondyloarthritis (AxSpA), as measured~     by the reduction in signs and symptoms of radiographic AxSpA.~   "
86198|NCT02438774|"~     It has been shown that exposure to mycotoxins through complementary foods and breast milk had~     profound effects on growth of children from 6 months to 1 year of age. In Tanzania maize is~     the main ingredient for complementary food, however, the crop is vulnerable to mycotoxins~     contamination. it has been reported that the most effective way to reduce mycotoxin exposure~     is to lower the mycotoxins contamination of maize. This study has developed a post-harvest~     intervention package for use in rural Tanzania to reduce contamination of maize and breast~     milk with two forms of mycotoxins; aflatoxins and fumonisins. It is composed of 5 components;~     1) hand sorting, 2) drying surface, 3) proper drying 4) application of insecticide, 5)~     dehulling and was introduced in three main maize producing agro-ecological zones. The~     intervention used randomised controlled trial design where infants less than 8 six months of~     age were recruited and followed up 6 months after recruitment. The intervention expects to~     demonstrate the effectiveness of the post harvest intervention package in reducing aflatoxins~     and fumonisins contamination of maize and subsequent exposure of these toxins to infants and~     young children through maize based complementary food and breast milk. The findings will be~     used in developing guidelines for farmers and extension officers to reduce aflatoxins and~     fumonisins contamination of maize and improve the health of the infants and the whole~     population.~      The study hypothiseses that introducing post-harvest intervention package can reduce~     aflatoxins and fumonisins contamination of maize and subsquent exposure of these toxins to~     infants and young children through maize based complementary foods and breast milk than~     routine agriculture extension services offered to the farmers in rural Tanzania. The specific~     objectives include;~        -  To evaluate the effectiveness of post-harvest intervention package on reduction of~          aflatoxins and fumonisins contamination of maize and in breast milk~        -  To perform exposure assessment of aflatoxins and fumonisins to infants and young~          children through maize based complementary food and breast milk~        -  To perform risk characterization of aflatoxins and fumonisins exposure to infants and~          young children through maize based complementary foods and breast milk~        -  To assess the association between exposure to aflatoxins and fumonisins and child growth~   "
86199|NCT02438761|"~     Phase II open-label single-arm prospective multicentric clinical trial of PF-05212384~     (PKI-587) delivered by intravenous route. A 2-stage Fleming design will be employed.~   "
86226|NCT02438410|"~     To assess if infliximab drug levels in subjects with Ulcerative Colitis predict risk of~     colectomy rate. Additionally, the investigators will estimate an optimal day 4 infliximab~     level based on the study results.~   "
86202|NCT02438722|"~     This randomized phase II/III trial studies how well afatinib dimaleate with cetuximab works~     and compares it with afatinib dimaleate alone in treating patients with newly diagnosed stage~     IV or recurrent (has come back), epidermal growth factor receptor (EGFR) mutation positive~     non-small cell lung cancer. Afatinib dimaleate may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, may~     block tumor growth in different ways by targeting certain cells. It is not yet known whether~     afatinib dimaleate is more effective when given alone or with cetuximab in treating patients~     with non-small cell lung cancer.~   "
86203|NCT02438709|"~     The purpose of this study is to determine whether COX-2 inhibitor is effective in the~     treatment of primary hypertrophic osteoarthropathy~   "
86204|NCT02438696|"~     The primary objective is to investigate the relative bioavailability of two newly developed~     tablet formulations of BI 1060469 vs BI 1060469 TF1 formulation. The secondary objective is~     the comparison of several pharmacokinetic parameters between the treatments.~   "
86205|NCT02438683|"~     This trial will be conducted to further evaluate, in a controlled setting, potential cardiac~     effects of an anticipated therapeutic and supra-therapeutic dose of BI 409306 under resting~     and exercise conditions. Since the drug is being developed in part for a disease with an~     expectedly high number of elderly (AD), the characterization of cardiac safety of BI 409306~     is considered to be important for the development of this compound.~      This trial will be conducted to further evaluate, in a controlled setting, potential cardiac~     effects of an anticipated therapeutic and supra-therapeutic dose of BI 409306 under resting~     and exercise conditions.~      Since the drug is being developed in part for a disease with an expectedly high number of~     elderly (AD), the characterization of cardiac safety of BI 409306 is considered to be~     important for the development of this compound.~   "
86206|NCT02438670|"~     The goal of this proposed study is to compare use of a PID (Proportional-Integral-Derivative)~     controller versus an MPC (Model Predictive Control) controller algorithm in an artificial~     pancreas system, all other components and study design being equal. The study design, power~     calculation and endpoints were developed based on the results of an initial feasibility study~     (ClinicalTrials.gov Identifier: NCT01987206) that has already been completed.~   "
86207|NCT02438657|"~     Ultrasound guidance can reduce the required local anesthetic volume for successful peripheral~     nerve block.~      The aim of the study is to determine the minimum volume of local anesthetic to achieve an~     ultrasound-guided median nerve block with a dextrose 5% hydrodissection approach.~   "
86208|NCT02438644|"~     This observational, noninterventional study is designed to further characterize the~     effectiveness and safety profile of vismodegib (Erivedge) in Argentine patients. Only~     patients with locally advanced basal cell carcinoma (laBCC) or metastatic basal cell~     carcinoma (mBCC) will be considered in the effectiveness analysis. Study duration is~     estimated to be approximately 12 months.~   "
86209|NCT02438631|"~     The investigators aim to integrate the outcomes in physiology-based pharmacokinetic (PBPK)~     models to put the generated data into context with medical conditions that require maternal~     or fetal drug therapy (e.g. HIV). These models will be validated with available 'real-life'~     maternal and fetal PK data, such as data from the PANNA network.~      Ultimately, these PBPK models of drug therapy during pregnancy will provide a powerful tool~     to 1.) assist in designing rational dosing adjustments, 2.) prevent intervention-based~     research in pregnant women in the future, and 3.) guide future development of new molecular~     entities (e.g. preventing heavy investment in drugs with high predicted fetal exposure and~     potentially toxic effects in utero).~   "
86210|NCT02438618|"~     The objective of this study is to make a comparison between two surgical techniques used when~     implanting a Ponto bone anchored hearing system.~   "
86211|NCT02438605|"~     The Nellix Endovascular Sealing Prosthesis (EVAS) endoprosthesis is a new device aimed at~     prophylactic treatment of abdominal aortic aneurysms. In regular follow up conventional~     CT-imaging is used for surveillance. In this study dynamic CT imaging in patients pre- and~     post-operative will be assessed for device changes and anatomical variances.~   "
86212|NCT02438592|"~     This is an observational study involving retrospective and prospective medical record review~     covering a total maximum of 104 weeks (24 months) per subject. An Audio Computer- Assisted~     Self-Interview (ACASI) at study entry will assess demographic and psychosocial variables of~     study subjects. Data will also be collected to assess clinic level variables. Definitions of~     engagement, prescription of antiretroviral therapy (ART), and viral suppression in the~     Continuum of Care (CoC) will utilize common definitions including those by U.S. Department of~     Health and Human Services (DHHS) and Health Resources and Services Administration (HRSA)~     HIV/AIDS Bureau (HAB). Data will be collected in a large, simple trial design manner to~     provide all elements for both the primary and secondary outcomes.~   "
86213|NCT02438579|"~     Viral upper respiratory tract infections (URTI), one of the commonest infection faced by~     humans, have a significant impact on individuals, families, health service and economy.~     Though rhinoviruses are called the common cold virus, numerous viruses can cause URTI.~     Hence virus specific remedy for URTI is impractical. There are currently no evidence-based~     interventions that reduce the severity, symptom duration or viral shedding. Preliminary~     evidence suggests that hypertonic saline nasal irrigation and gargling (HSNIG) may reduce the~     duration of symptoms.~      With this pilot randomised controlled trial (RCT), the investigators aim to assess the~     feasibility of undertaking a definitive RCT of HSNIG in adults with URTI. This pilot focuses~     on recruitment rate, willingness to be randomised, acceptability, compliance and likely~     effect size of the intervention.~      This pilot RCT compares HSNIG vs. usual care in 60 adults. Serial self-collected~     mid-turbinate swabs will help assess change in viral shedding. Symptomatic relief is measured~     by a validated symptom score. A questionnaire based participant feedback will help assess~     intervention and trial procedures.~      This mixed-methods pilot trial will help inform plans for a definitive RCT of this low-cost~     intervention that has the potential of substantial health and societal benefits.~   "
86214|NCT02438566|"~     The purpose of this research is to determine if the oral form of a medication (tranexamic~     acid) to reduce bleeding can be used in place of an intravenous (IV) form, to learn the best~     way to give tranexamic acid: either a pill by mouth, or a solution by vein.~   "
86215|NCT02438553|"~     The purpose of this study is to evaluate the short-term effectiveness of combined occipital~     and supraorbital transcutaneous nerve stimulation in reducing migraine related pain.~   "
86216|NCT02438540|"~     The investigators designed this randomized double blind (patients/ assessor) clinical trial~     to compare the therapeutic effects of Metformin monotherapy with Metformin and acupuncture~     combined therapy on weight loss and insulin sensitivity among overweight/obese type 2~     diabetes mellitus (T2DM) patients. We compared the inflammatory markers, lipid profiles, and~     adipokines in overweight/obese T2DM patients receiving the combined therapy to those~     receiving the Metformin monotherapy, to understand whether acupuncture plus Metformin is a~     better approach then Metformin only on treating diabetes.~   "
86217|NCT02438527|"~     ABSTRACT~      Background:~      More than two thirds of sudden cardiac arrests are witnessed by bystanders. Bystander~     cardiopulmonary resuscitation (CPR) doubles survival from cardiac arrest. Importantly, even~     in witnessed cardiac arrests only 20% of the bystanders commence basic life support. Common~     reasons for not commencing include panicking and the perceived inability to perform CPR~     correctly. A meta-analysis could demonstrate that a simplification of the algorithm~     (compression-only dispatcher-assisted bystander CPR) led to a 22% increase in~     survival-to-hospital discharge. A recently published trial of the research group could~     demonstrate that the presence of a flowchart has a positive effect on the quality of BLS~     while at the same time increasing the rescuers' confidence. Nonetheless, performing CPR is~     exhausting. Previous publications have emphasized increasing fatigue with the duration of CPR~     efforts in both, standard and chest compressions-only CPR. Consequently, we wanted to test~     the hypothesis that chest compressions (CC) are delivered more correctly regarding the depth~     when utilizing the standard BLS algorithm with the aid of a flowchart as compared to the CC~     only algorithm utilizing an adapted CPR flowchart in a manikin resuscitation model.~      Methods:~      After consent of the Research Ethics Board of Medical University of Vienna and obtaining~     written informed consent of the participants, 84 medically untrained laypersons will be~     randomised to perform flow-chart assisted CPR for 300s following standard CPR guidelines or~     CC only CPR. The primary outcome parameter will be the total number of CC achieving the~     correct depth of 50-60mm. Secondary outcome parameters will be hands-off time, the total~     number of CC, and the compression rate. The total number of delivered rescue breaths, tidal~     volume, and time to deliver these will also be evaluated. Furthermore, the subjective point~     of exhaustion affecting the CPR quality, the reason for discontinuation of CPR if stopped~     within the 300sec. period and the exhaustion at the end of the CPR measures will be~     evaluated.~   "
86218|NCT02438514|"~     The investigators propose to evaluate the potential utility of stress-related biomarkers~     obtained via dried blood spots (DBS) and retinal scans by collecting new data from mothers~     and children within the New Haven MOMS Partnership, a well-established community-partnered~     research setting. The proposed research could greatly advance the application of~     stress-related biomarkers within community-based research by increasing our understanding of~     how stress, trauma, and depression influence biology in childhood and adulthood, as measured~     using minimally-invasive approaches.~   "
86219|NCT02438501|"~     Many trials that patients with advanced or recurrent indolent lymphoma managed with very~     low-dose (4Gy) limited-field RT (LD-IFRT) have shown that high response rates and durable~     remission can be achieved. However, the results of two phase III trials have failed to~     demonstrate the lasting response rate (RR) with LD-IFRT versus in other approaches.~     Histology, bulky tumor (>5 cm), higher number of prior chemotherapy regimens, adoption of~     rituximab, and age＞65 years have been shown to significantly influence response rates of~     LD-IFRT. The objectives of this trial investigate the efficacy of palliative low-dose~     involved-field radiation therapy in patients lower than 65 years of age with recurrent~     advanced follicular lymphoma.~   "
86220|NCT02438488|"~     Vitamin D deficiency is a risk factor for mortality but existing data are limited by missing~     standardization of laboratory methods for 25-hydroxyvitamin D (25[OH]D). In a European~     consortium of eight cohort studies we use protocols of the Vitamin D Standardization Program~     (VDSP) to obtain standardized 25(OH)D data. Individual participant data (IPD) meta-analyses~     using a one step procedure will be performed to study associations of original and~     standardized 25(OH)D with all-cause, cardiovascular, and cancer mortality.~   "
86221|NCT02438475|"~     Evaluate the safety of the MynxGrip™ extravascular sealant for common femoral vein closure~     following both diagnostic and interventional procedures as assessed by clinical and imaging~     criteria.~   "
86222|NCT02438462|"~     The purpose of the study is to evaluate the performances of Soluble Fibrin for diagnosing~     Pulmonary Embolism. Secondary objective is to compare the diagnostic performances of the~     Soluble Fibrin Assay and the D-Dimer test.~   "
86223|NCT02438449|"~     It is estimated that about 25% and 40% of health care expenditures in Canada and USA~     respectively are wasted because of inefficiencies and not practicing evidence-based medicine.~     As health care resources are scarce it behooves all of us to use these in a cost-effective~     manner. The term cost-effective is used in the health care literature often but~     erroneously. Investigators compare a novel' intervention to a prevailing one and if the~     novel intervention is less costly it is labeled cost-effective. In a methodologically~     correct cost-effectiveness study however, investigators need to integrate both the~     effectiveness and costs of the competing interventions and calculate an incremental~     cost-effective ratio. If this ratio falls within acceptability thresholds, the novel~     intervention is labeled cost-effective. There are many techniques of breast reconstruction.~     The two most common approaches are the Autologous Abdominal Tissue (AAT) and the Tissue~     Expansion / Implant reconstructions. In this study these two most common breast~     reconstruction approaches after mastectomy due to cancer performed in the~     Hamilton/Niagara/Haldimand/Brant and Waterloo/Wellington LHINs will be investigated with a~     cost-effectiveness analysis coupled with a methodologically robust observational study.~   "
86224|NCT02438436|"~     Abdominal surgery, including hepatic resection for hepatocellular carcinoma (HCC), is~     inevitably followed by an episode of gastrointestinal hypomotility. A delayed return of~     gastrointestinal function, defined as postoperative ileus (POI), has a great impact on~     patient comfort, morbidity and recovery. POI often results in a prolonged hospital stay and~     contributes significantly to healthcare costs.~      Some prospective studies have revealed that gum chewing can improve the return of~     gastrointestinal function after colorectum surgery, gynaecology and obstetrics, and urinary~     system surgery. Moreover, some retrospective studies also revealed that simo decoction may~     improve the return of gastrointestinal function after hepatic resection of HCC. Therefore,~     the present study compared the effect of gum chewing and simo decoction after hepatic~     resection of HCC on POI, surgical complications, and length of hospital stay.~   "
86225|NCT02438423|"~     Title: A Phase I Study of The Safety, Reactogenicity, Acceptability and Immunogenicity of~     Inactivated Influenza Vaccine Delivered either by Microneedle Patch or by Hypodermic Needle.~      This is a single center, partially blinded, randomized phase I study in which healthy adult~     subjects (ages 18-49) will receive either inactivated influenza vaccine (IIV) (either by~     microneedle patch or hypodermic needle) or placebo (by microneedle patch). This study is~     designed to investigate the safety, reactogenicity, acceptability and immunogenicity of an~     inactivated influenza vaccine delivered by microneedle patch.~   "
86230|NCT02438358|"~     For most breast cancer patients, surgery is the primary treatment. When patients undergo a~     lumpectomy, it is difficult for the surgeon to determine the extent of the tumor which~     results in incomplete tumor removal as determined by a positive margin assessment several~     days after the initial surgery is completed. Most patients with positive margins will undergo~     a second or even a third surgery to complete the tumor removal. The investigators hypothesize~     that the LUM Imaging System can reduce the rates of positive margins and, thus, the rates of~     second surgeries by identifying microscopic residual cancer in the tumor bed.~      This is a non-randomized, open label study to evaluate the safety and efficacy of an~     intraoperative imaging system, the LUM Imaging System (LUM015 in conjunction with LUM 2.6~     Imaging Device), in identifying residual cancer in the tumor bed of female breast cancer~     subjects. The study is composed of a Feasibility Trial divided into two phases: Phase A (15~     total subjects) and Phase B (up to 50 total subjects). During Phase A, 15 subjects will be~     evaluated to collect additional patient safety data, select the dose of LUM015 for Phase B~     and evaluate the device function. During Phase B, subjects will be injected with LUM015 at~     the dose determined during Phase A to preliminarily assess the performance of the detection~     algorithm against pathology margin assessment. In Phase B, the surgeon will perform standard~     of care surgery and then use the LUM Imaging System to guide the removal of additional cavity~     shavings as indicated by the LUM Imaging System.~   "
86231|NCT02438345|"~     PRO 140 2102 is a multicenter, randomized, double-blind, placebo-controlled, clinical trial~     of observed systemic, long-acting, anti-HIV treatment with a monoclonal CCR5 antibody (PRO~     140) as an adjunct to a new, optimized, oral antiretroviral regimen in HIV-infected injection~     drug users with viral rebound and documented poor adherence to the previous antiretroviral~     regimen. Eligible subjects (approximately 76) will be randomized 1:1 to receive an optimized~     background antiretroviral regimen (OBR) plus supervised weekly subcutaneous treatment with~     either PRO 140 or placebo. Blood samples for safety and efficacy variables will be obtained~     over the 24 week duration of the study. Safety will be monitored throughout the course of the~     study.~   "
86232|NCT02438332|"~     This study will evaluate the incidence of reoperations associated with the use of smooth and~     textured NATRELLE® INSPIRA® TruForm® 1 and TruForm® 2 devices in patients who have undergone~     primary breast augmentation.~   "
86233|NCT02438319|"~     Manually and automatically by mashing learning algorithm optic disc will be evaluated~     (planimetry).~   "
86234|NCT02438306|"~     This is a prospective, multi-center, randomized (3 Treatment : 2 Sham Control),~     sham-controlled, patient and evaluator-blinded study comparing treatment with the CardiAMP~     cell therapy to a sham treatment.~      A roll-in phase with a maximum of 10 subjects will precede the randomised phase.~   "
86235|NCT02438293|"~     This is a prospective single- center observational study in the Leiden University Medical~     Center in approximately 250 children (<12 years) undergoing elective cardiac surgery, for~     congenital heart disease. The parents/guardians of the children will be asked to fill out a~     questionnaire, to asses respiratory symptoms in the last weeks, before the operation of their~     child. In the operating theatre, a nasopharyngeal swab will collected. Clinical data will be~     collected daily during paediatric intensive care admission, and date of discharge from~     paediatric intensive care unit and from hospital are recorded. If children are still~     intubated at day 4 a second nasopharyngeal swab and residual blood will be collected. The~     samples will be tested for rhinovirus with a polymerase chain reaction. Main study parameter~     is the paediatric intensive care unit length of stay in per-operative rhinovirus -positive~     compared to rhinovirus-negative patients.~   "
86236|NCT02438280|"~     The AcceleDent® device has been introduced to the specialty of orthodontics in order to~     reduce treatment time. The theory behind AcceleDent® is that high frequency vibratory forces~     (30Hz) delivered to the teeth will stimulate the bone remodeling that is necessary for tooth~     movement to occur more quickly.~      Additionally, one claim of the AcceleDent® product is that it may reduce pain and discomfort~     during orthodontic treatment.~      This study will be a parallel group, triple-blind randomized clinical trial comparing two~     groups of subjects with 12 participants in each group. Subjects will be randomized to receive~     one of two vibrational units, which will differ in frequency and/or amplitude of vibration.~     The subjects will be asked to change their aligners every week instead of every 2 weeks,~     which is common with Invisalign.~   "
86237|NCT02438267|"~     Nephrocalcinosis (NC), defined as calcification of renal tissue, has been reported to occur~     in 7-41% of premature infants. Causes of NC are likely multi-factorial, and infants born~     prematurely and with very low birth weight (<1500 gm) seem to be at the highest risk of~     developing NC. Recent changes in recommendations for nutrition for the preterm infant such as~     higher intakes of protein, calcium, and vitamin D may also play a factor in the pathogenesis~     of NC.~      Currently, diagnosis of NC often occurs incidentally during ultrasound evaluation for other~     issues. Because there is no acute symptom or pattern of symptoms in the preterm population~     associated specifically with NC, it is possible that many cases of NC may not be diagnosed.~     Presently, it is impractical and costly to screen all infants for NC with renal ultrasound,~     therefore there is no standard of care regarding screening for NC.~      NC may have long-term effects. Studies have shown that preterm infants with NC had shorter~     kidneys and a lower rate of tubule resorption of phosphorus (TRP) than preterm infants~     without NC.~      This study will analyze weekly urinalysis for all enrolled subjects prospectively and then~     look at the incidence of NC at discharge of the enrolled subjects.~   "
86238|NCT02438254|"~     The researchers are studying factors that may increase the risk for alcohol and drug use in~     individuals who do not have any problems with these substances. This study will be looking at~     health behaviors in young adults compared to their family's health behaviors and lifestyle.~      The investigators plan to study genetic differences in people with and without a family~     history of alcoholism. The researchers hope to learn how a family history of alcoholism,~     early life adversity and different genotypes shape personal characteristics associated with a~     risk for alcoholism.~   "
86266|NCT02437890|"~     Primary objective:~      To assess the efficacy and safety of different dose regimens of ALX-0061 administered~     subcutaneously (s.c.) to subjects with moderate to severe active, seropositive SLE compared~     to placebo.~      Secondary objectives:~      To assess the pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, flare rate,~     steroid reduction and health-related quality of life, with different dose regimens of~     ALX-0061.~   "
86239|NCT02438241|"~     Introduction: Pain is an important factor of increase of morbidity and mortality in patients~     undergoing surgical procedures include thoracotomy. There are different methods of analgesia~     in postoperative thoracic surgery, ranging from systemic analgesia with opioids, as well as~     local anesthetics block (intrapleural, extrapleural, intercostal cryoanalgesia, etc.) in~     addition to spinal blocks and Epidural blocks. In the pharmacological analgesia,~     electroanalgesia has been proposed as an adjunctive treatment for the relief of postoperative~     pain. Rationale: noting the lack of data in the literature regarding the use of this physical~     therapy technique in order to reduce the pain in the postoperative period of thoracic surgery~     and its consequences, it is relevant to the realization of a new randomized controlled trial~     (RCT) to evaluate the effects of transcutaneous electrical nerve (TENS) in the post -~     thoracic surgery on pain, pulmonary function and strength respiratory muscle. Objective: To~     evaluate the effects of TENS on pain, respiratory muscle strength and lung function in~     postoperative thoracic surgery in a Intensive Care Unit. Method: The subjects included will~     be randomized into three groups randomly: control group (CG) that will hold only conventional~     physical therapy, TENS group (EG) that will hold the application of TENS associated with~     conventional physical therapy, TENS placebo group (GP) who will perform the application of~     TENS placebo to conventional therapy. All groups carry out the assessments (digital~     manometer, spirometry, visual analog pain scale) in the preoperative period, postoperative~     Immediate / pre-intervention and at the end of treatment (discharge from the intensive care~     unit), except for the pain that will be evaluated before and after each intervention session.~     All patients receive physical therapy three times a day (morning, afternoon and evening)~     during hospitalization in the intensive care unit. Intervention: The conventional group will~     receive conventional therapy for hospital service. The TENS group will receive conventional~     therapy and the end of that service, will be applied TENS for 30 minutes. The placebo TENS~     group will receive the conventional physical therapy and the end of the service will be~     installed TENS placebo, during this period the patient receives electrical stimulation for 45~     seconds, shutting down at the end of this time and held position as TENS group.~   "
86240|NCT02438228|"~     The aim of the present study is to compare accuracy and precision of Cardiac Output (CO) by~     nine different pulse contour algorithms with transpulmonary thermodilution before and after~     cardiopulmonary bypass (CPB).~   "
86241|NCT02438215|"~     This is a single site, open-label study designed to examine dopamine transporter density~     using [123I]β-CIT SPECT imaging before and following treatment with IRX4204 for a 30-day~     period in early Parkinson's disease patients. In addition, clinical evaluations will be~     performed to evaluate the effect of IRX4204 treatment on the motor and cognitive symptoms of~     PD.~   "
86242|NCT02438202|"~     Electroconvulsive therapy (ECT) induces a cerebral seizure by electrical stimulation under~     general anesthesia and muscle relaxation, is regarded as a highly efficient (for specific and~     severe psychiatric disorders) and extremely safe modern treatment option.~      Alzheimer´s disease (AD) is a neurodegenerative disorder which is characterized by~     progressive cognitive deterioration accompanied by declining activities of daily living, by a~     variety of behavioral disturbances and by neuropsychiatric symptoms. The clinical progression~     of disease can be delayed by pharmaceutical therapies like acetylcholinesterase inhibition~     (e.g. rivastigmine) for 6 to 12 months at most.~      Along with the well-known biomarkers of AD (Aß- and tau-proteins) a lower brain-derived~     neurotrophic factor (BDNF) level is since recently being considered as a negative predictor~     for the further disease course. In animal experimental studies it was possible to arrest the~     disease progression with the aid of neurotrophic substances. Many single studies, but also a~     number of meta-analyses show primary gray matter atrophy in hippocampal, parahippocampal and~     medial temporal brain regions.~      Strikingly, ECT yields exact opposite effects to those caused by AD: an ECT series leads to~     an increase of serum BDNF-levels in patients. Parallel to this observation evidence exists~     for gray matter volume gain after an ECT series, especially for the hippocampus.~      There is sufficient clinical experience regarding the use of ECT in AD-patients, mainly on~     the basis of following indications: a) affective disorders and b) behavioral disturbances. A~     positive effect of ECT on the symptoms of agitation and aggression was assessed in AD~     patients alongside with a very good tolerability.~      To investigate the potential salutary effects of ECT on AD the investigators designed a pilot~     study with the following concept: Patients with a confirmed AD diagnosis and preexisting~     stable antidementia medication over at least 6 months will receive a modified maintenance ECT~     over a total of 27 weeks.~      In the proposed pilot study, the investigators hypothesize that cognitive functioning of AD~     patients will improve significantly and independently from affective symptoms, when initial~     and final examinations are compared. The affirmation of the hypothesis would provide not only~     further insight into the mechanism of action of ECT but also a very important reference point~     for the development of new treatment options for a so-far incurable disease.~   "
86243|NCT02438189|"~     Objective: to gain experience with in-home use of a modified algorithm that will dose insulin~     to minimize projected hyperglycemia overnight in addition to suspending the pump if~     hypoglycemia is projected overnight and to obtain feasibility, safety, and initial efficacy~     data.~      Study Design: randomized controlled trial, with randomization on a night level within~     subject.~      Major Eligibility Criteria: clinical diagnosis of type 1 diabetes, daily insulin therapy for~     at least one year and an insulin infusion pump for at least 6 months; 15.0 to <46.0 years of~     age; HbA1c < 10.0%; no DKA in last 6 months; no hypoglycemic seizure or loss of consciousness~     in last 6 months; Living with a significant other or family member (companion) committed to~     participating in all study activities, and being present and available to provide assistance~     when the system is being used at night.~      Sample Size: 30 subjects.~      Study Duration and Visit Schedule: duration approximately 3 months, with preliminary run-in~     activities followed by up to 90 days spent in clinical trial phase of study; clinic visits at~     enrollment, following CGM and system assessment run-in phases, at start of clinical trial~     phase, at 21-day point of clinical trial phase, and after 42 nights of successful system use.~      Major Efficacy Outcomes:~        -  Primary: time in range (70-180 mg/dl, 3.9-10.0 mmol/L) overnight.~        -  Secondary: time spent in hypoglycemia (≤70 mg/dl, 3.9 mmol/L) and time spent in~          hyperglycemia (>180 mg/dl, 10.0 mmol/L) overnight.~      Major Safety Outcomes: CGM measures of hypo- and hyperglycemia, including morning blood~     glucose and mean overnight sensor glucose; adverse events including severe hypoglycemia and~     diabetic ketoacidosis.~   "
86244|NCT02438176|"~     The purpose of this study is to compare single groin puncture and bilateral groin puncture~     during AF ablation procedure. The investigators will compare 1) the degree of patients'~     discomfort during hemostasis by questionaire, 2) procedure time, 3) complication rates, and~     4) 1-year clinical recurrence rate of AF.~   "
86245|NCT02438163|"~     Neuroplasticity is supposed to be altered in patients suffering from a Major Depressive~     Disorder (MDD). Transcranial Magnetic Stimulation is a medical device which measures cerebral~     plasticity. Several parameters of cortical excitability are available for that purpose. These~     parameters are altered on patients wth MDD and these modifications are corrected after~     treatment. Therefore results in the studies are very heterogeneous. Theta Burst Stimulation~     (TBS) is a type a Transcranial Magnetic Stimulation (TMS) protocol and can induce cerebral~     plasticity. The cerebral plasticity induced by TBS was measured on a group of patients~     suffering from Asperger's disease (ASD) versus a control group. The plasticity was~     significantly different in patients with ASD. The aim of our study is to study the~     neuroplasticity induced by TBS on a patients with MDD.~   "
86267|NCT02437877|"~     Purpose: To examine whether nasal breathing influences the perception of sound causing trade~     between hard and soft consonants in the writing of children in school age and the incidence~     of trade.~   "
86459|NCT02435368|"~     To determine the mechanisms and significances of synergistic effects of mycophenolic acid and~     LPS on IL-1β secretion by mononuclear~   "
86246|NCT02438150|"~     Objective: To investigate the effectiveness of an online training program on medical staff in~     five public hospitals located in Sichuan, Yunnan, Hubei, and Fujian Provinces of China, on~     improving fire knowledge.~      Methods: Participants will be randomly divided into control (receiving non-fire video~     training) and intervention (receiving hospital fire video training) groups. All participants~     will complete a questionnaire of fire knowledge before and after receiving the training.~      Hypothesis: If the online training is effective, it can be promoted as a convenient and~     effective use of training and be promoted to other hospitals.~   "
86247|NCT02438137|"~     The overall purpose of this study is to determine whether the oral medication dimethyl~     fumarate is an effective treatment for obstructive sleep apnea in patients who are unable,~     unwilling, or uneager to use positive airway pressure therapy.~   "
86248|NCT02438124|"~     The beneficial effects of rhythmical auditory stimulation (RAS) on spatio-temporal gait~     characteristics in Parkinson's disease (PD) are attested by clinical research.~      Nonetheless, it is still unclear which auditory information parameters (i.e. complexity,~     temporal regularity or adaptability to gait) maximize the effectiveness of RAS.~      Objectives: To evaluate the beneficial effects of RAS on spatio-temporal gait characteristics~     in PD patients with gait disorders according to:~        -  RAS complexity (i.e. metronome, amplitude modulated noise, music)~        -  RAS variability (i.e fixed, random, semi-random)~        -  RAS adapted in real-time to gait~      Variability study:~      To study the impact of RAS variability (i.e fixed, random, semi-random) in 20 PD patients and~     20 healthy controls on spatio-temporal gait characteristics with metronome, amplitude noise~     and music.~      Adaptability studyTo study the impact of RAS adaptability (i.e fixed, random, adapted in~     real-time to gait) in 20 PD patients and 20 healthy controls on spatio-temporal gait~     characteristics with metronome, amplitude noise and music.~   "
86249|NCT02438111|"~     The primary objective of this study is to assess whether compositional and functional~     alterations of the gut metagenome may be related to AMD. The primary variable for this~     assessment is the composition of the gut metagenome which will be analyzed by shotgun~     sequencing to characterize the faecal metagenome. The secondary endpoint is to assess whether~     single nucleotide polymorphisms in CFH, ARMS2, C3, PLEKHA1, HTRA-1, VEGF-A, VEGF-B, VEGFR and~     APOE genes which have been shown to be risk factors for the development of AMD and other~     macular diseases correlate with alterations in the gut metagenome .~   "
86250|NCT02438098|"~     Until now there ist no systematic investigation of the pharmacokinetic parameters of~     Rivaroxaban in obese patient undergoing bariatric surgery. The aim of this study is to~     investigate the pharmacokinetic and pharmacodynamic parameters of rivaroxaban in obese~     patients before and after bariatric surgery.~      Patients receive the day before the surgical intervention the first dose of Rivaroxaban~     (10mg). During the following 24 hours, 9 blood samples are taken.~      The second tablet Rivaroxaban is administered on the third postoperative day, followed again~     by 9 blood samples during the next 24 hours.~      All other blood samples are taken independent from this clinical trial as part of the~     standard medical treatment during the hospitalization. The hospital stay will not be extended~     by the study. The outpatient regular follow-up takes place one month after surgery and is~     combined with the last study visit.~   "
86251|NCT02438085|"~     The ARYOSTO has been designed to describe the clinical epidemiology and the current~     management of acute coronary syndromes (ACS) in the area of Ferrara. Especially, the Authors~     will evaluate the medical and interventional management of ACS patients admitted to hospitals~     in the area of Ferrara and receiving coronary artery angiography and percutaneous coronary~     intervention (PCI) in the hub center of Ferrara (Azienda Ospedaliera Universitaria di~     Ferrara, Cona (FE), Italy)~   "
86252|NCT02438072|"~     We propose here to explore systematically the association between drug-metabolizing enzymes~     activity assessed by a phenotypical approach and antidepressant plasma concentration,~     efficacy and tolerance in the clinical setting. During one year, patients receiving~     antidepressant will be included in tis prospective clinical, naturalistic and descriptive~     pilot study.~   "
86253|NCT02438059|"~     The purpose of this study is to determine whether a web- and app-based tool for health~     promotion for social and health care workers in Denmark has an effect on body weight (primary~     outcome), body fat percentage, waist circumference, blood pressure, cholesterol and blood~     sugar in a 38 week intervention period.~   "
86254|NCT02438046|"~     In this study it will be investigated the usefulness of Platelet-Rich Fibrin (PRF) on in the~     epithelialized connective tissue graft palatal donor site healing acceleration and in the~     patient's morbidity reduction. Forty patients, with at least one gingival recession will be~     treated by a coronally advanced flap (CAF) with connective tissue graft(CTG) resulting from~     the de-epithelialization of a free gingival graft. In the test group (20 patients) a~     quadruple layer of PRF membrane will be placed over the palatal wounds; conversely, the~     control group patients will be treated by an absorbable gelatin sponge. Patients will be~     monitored at 1, 2, 3 and 4 weeks after surgery for the complete re-epithelialization of the~     palatal wound (CWE), the alteration of sensibility (AS) around the wound area, the~     post-operative discomfort (D), and the changes of feeding habits (CFH) by a visual analogic~     scale (VAS) evaluation. Furthermore, the analgesics consumption and the existence of delayed~     bleeding from the palatal wound (DWB) during the first post-operative week will be assessed.~   "
86268|NCT02437864|"~     Airway placement after anesthetic induction in pediatric patients is routinely performed at~     our institution without apneic oxygenation. When intubation is attempted by an inexperienced~     (learner) provider, the attending physician intervenes if necessary before the patient~     experiences excessive loss of oxygenation. The investigators plan to institute routine~     supplemental oxygenation via nasal cannula during this placement. This study will examine the~     effect of adding apneic oxygenation via nasal cannula on oxygen saturation.~   "
86269|NCT02437851|"~     This phase II trial studies surgery in treating patients with anal canal or perianal cancer~     that is small and has not spread deeply into the tissues and human immunodeficiency virus~     (HIV) infection. Local surgery may be a safer treatment with fewer side effects than bigger~     surgery or radiation and chemotherapy.~   "
86270|NCT02437838|"~     The primary objectives of this study are to examine whether augmented renal clearance (ARC)~     compromises renally eliminated drug therapeutic serum concentrations in patients with~     traumatic brain injury (TBI) and to estimate the optimal dose needed to achieve therapeutic~     serum concentrations of the probe medication levetiracetam in patients with TBI.~   "
86255|NCT02438033|"~     Deep brain stimulation for Parkinson's disease is a well established therapy. Current~     practice requires tedious adjustment of stimulation settings based on frequent patient~     assessments. Ultimately, the goal is to develop a system that can program itself using~     signals that are recorded directly from the brain on a continuous basis. Our previous work~     has identified abnormal electrical signals in the brain that are targeted for stimulation~     that can potentially be used to develop a self-programming system. In this study, the~     investigators will test the safety and utility of a novel adapted device that can not only~     deliver stimulation to the brain but also record brain signals in a patient that is implanted~     with a deep brain stimulation system. The purpose of this Phase I study is to understand the~     safety of the device as well as the relationship between these electrical signals measured~     from deep within the brain and Parkinson's symptoms and how these signals can be used to~     guide a self-programmed system. The study will entail implanting this special device (Activa~     PC+S) in place of the standard generator (Activa PC) and to compare clinical symptoms,~     recorded brain signals, and stimulation patterns during a one year period after implantation.~     Specifically, the investigators will use the Activa PC+S to record GPi (internal globus~     pallidus) local field potentials between and during programming visits, allowing the surgeon~     to better characterize a patient's disease. At the same time, the investigators will evaluate~     the safety of this new device.~   "
86256|NCT02438020|"~     Obesity is often accompanied by insulin resistance and/or hyperinsulinemia. Acanthosis~     nigricans (AN) is a skin condition commonly present on the neck of obese children. Metformin~     is a useful drug for conditions characterized by insulin resistance.The aim of this study is~     to compare the efficacy of metformin versus placebo on AN lesions of the neck as well as~     their effects on metabolic and anthropometric variables in a sample of obese children. This~     is a 12-week randomized, double-blind randomized trial involving obese children with AN to~     receive either metformin or placebo.~      Evaluations will be performed every three weeks. Clinical, histological and colorimetric~     assessments of AN lesions will be compared initially and at the conclusion of the study.~   "
86257|NCT02438007|"~     The purpose of this study is to compare galeterone to enzalutamide in men expressing androgen~     receptor spice variant-7 mRNA (AR-V7) in metastatic (M1) castrate resistant prostate cancer~     (CRPC).~   "
86258|NCT02437994|"~     Pulmonary rehabilitation is an essential non pharmacological treatment option which reduces~     dyspnea sensations, increase exercise tolerance, improves health related quality of life and~     reduces the burden on health care resources (1). Pulmonary rehabilitation is likely an ideal~     intervention to validate the PROactive tool as responses to pulmonary rehabilitation are~     clinically significant in terms of exercise tolerance and particularly activity related~     symptoms. Nevertheless, the response to pulmonary rehabilitation is variable and about one~     out of three patients does not present a clinically important response. Pulmonary~     rehabilitation may therefore be an intervention that allows studying the conceptual model~     around the PROactive tools, anchoring the new PROs (Patient Report Outcome) to outcomes that~     are well known to change with rehabilitation: exercise induced symptoms, functional exercise~     tolerance and health related quality of life.~      Study objectives~      Main objectives~      A primary aim is to test reliability of the paper-pencil versus the electronic scoring~     version of the PROactive tool in terms of assessing the effect of pulmonary rehabilitation on~     the components of the PROactive tool and on the mode of administration.~      The secondary aim of the proposed project is to investigate the effects of a~     multidisciplinary outpatient hospital-based, pulmonary rehabilitation program on: i) daily~     physical activity (number of daily steps, vector magnitude unit and movement intensity and~     ii) the components of the Proactive tool.~      Additional study objectives~      A third aim of this project is to investigate whether the magnitude of change in daily~     physical activity and the components of the PROactive tool in general is associated with the~     magnitude of changes in frequently used rehabilitation related end-points including,~     functional capacity, exercise capacity and health-related quality of life following the~     completion of a comprehensive pulmonary rehabilitation program.~      A forth aim of this project is to investigate whether the magnitude of change in daily~     physical activity and the components of the PROactive tool in general is associated with the~     magnitude of changes in physiological indices including cardiovascular and respiratory~     adaptations following completion of a comprehensive pulmonary rehabilitation program.~   "
86259|NCT02437981|"~     PrEP-30 is a demonstration project to assess the feasibility of providing oral PrEP to MSM~     and other individuals at-risk for HIV in Bangkok, Thailand as a service that is funded~     entirely through user fees. Tenofovir disoproxil fumarate/emtricitabine PrEP is provided part~     of a combined HIV prevention program that includes risk-reduction counseling, regular HIV~     testing, and the provision of condoms and lubricants. PrEP-30 is implemented at the Thai Red~     Cross AIDS Research Centre, at the site of the largest HIV counseling and testing center in~     Thailand.~   "
86260|NCT02437968|"~     The present study aims to test the implementation and sustainability of (a) a~     Computer-Assisted Cognitive-Behavioral Treatment (CACBT) for youth anxiety and (b) the BASC-2~     TRS to identify anxious youth in the school setting using a cohort-sequential design (i.e.,~     three years at 20 schools over the span of five years).~      'Camp Cope-A-Lot (Computer-assisted CBT program)'~   "
86261|NCT02437955|"~     In Senegal, iron deficiency affects 39% of and 82% of women and children between 12 and 50~     months indicating that iron deficiency is a major health problem. The government of Senegal~     has implemented a flour fortification program including iron and folate. Iron is a difficult~     mineral to add to foods efficiently due to its organoleptic properties and typical low~     bioavailability in man. The aim of this study is to determine iron absorption from fortified~     wheat flour consumed with a phenolic containing beverage in women and child pairs. The~     fortificants used will be Ferrous Fumarate and Ferrous Sulfate, and the effect of absorption~     inhibitors on the bioavailability from iron compounds not readily bioavailable is poorly~     investigated.~      The bioavailability of the different iron compounds will be determined using stable iron~     isotopes. Sixteen pairs of women and children (n=34, children between 3-6 years, women~     between 18-45y) will be selected for participation in the study. After a screening, each~     women and child will receive 4 test meals consisting of a bread roll fortified stable~     isotopes with and without the tisane beverage. The first two test meals will be consumed on~     consecutive days. Two weeks after the second test meal a blood sample will be taken from each~     women and child before the third meal administration. After the forth test meal~     administration, and again two weeks later, the last blood sampling will take place and the~     study will be conducted for the subjects (duration 30 days). The samples will be sent to~     Zurich on dry ice for analysis for the following parameters: isotopic composition, H pylori~     infection, B vitamin status, Vitamin A status. In all samples, hemoglobin and iron status as~     well as inflammation status (CRP) will be determined.~   "
86262|NCT02437942|"~     Athletic groin pain (AGP) is a chronic condition common in multi-directional sports (Walden~     et al. 2007, Robinson et al. 2004, Murphy et al. 2012). It is a complex injury with a~     challenging diagnosis. Dramatic differences in the anatomical diagnoses of AGP cohorts exist~     in the literature (Renstrom et al. 1980, Lovell et al. 1995, Holmich et al. 2007, Bradshaw et~     al. 2008). This may be due to the complexity of the anatomy in the region and the absence of~     magnetic resonance imaging (MAGNETIC RESONANCE IMAGE) to confirm clinical examination.~      Dynamic actions undertaken in field sports (including change of direction cutting) are~     particularly associated with the development of athletic groin pain (Holmich et al. 2014).~     Dynamic multi-plane, multi-joint actions can overload musculoskeletal and fascial structures~     in the hip and groin. Despite this, traditional groin pain assessments do not involve an~     examination of sport specific actions. An examination of jumping, hopping and cutting~     mechanics, which is possible with the use of three dimensional motion capture techniques,~     will provide additional information with which to diagnosis and rehabilitate athletes.~      While the majority of published studies on AGP have focused on surgical management (Serner et~     al. 2015), exercise therapy has been found to be an effective treatment (Holmich et al.~     1995). In exercise therapy studies the best results were shown by Holmich et al (1995) where~     subjects suffered for an average of 9.9 months with symptoms and a strength and stability~     program focused on adductor strength returned them to sport in 18.5 weeks. The latest paper~     on rehabilitation by Jardi et al. demonstrates little improvement with a mean time to return~     to training of 86 days +/-15. The focus remains on improving strength of isolated muscle~     groups and not attempting to address underlying biomechanical abnormalities that may be~     leading to overload. Accurate biomechanical assessment and individualized rehabilitation~     based on the high speed multiplanar movements that drive the athlete's symptoms may enhance~     the efficiency of rehabilitation. Moreover post-rehabilitation changes in biomechanical~     factors may provide a further insight into the biomechanical factors associated with AGP.~      The purpose of this study was to:~        1. Describe clinical presentation (physical examination and magnetic resonance imaging~          findings) for a group of athletes presenting with AGP~        2. To describe the different biomechanical diagnoses that exist in AGP patients~        3. To examine the effects of a biomechanics led exercise intervention to rehabilitate~          chronic groin pain~      It is hypothesised that standardised magnetic resonance imaging will aid in the anatomical~     diagnosis of athletic groin pain patients. From a biomechanics perspective, distinct~     subgroups/clusters will exist that differ from each other in how they undertake dynamic sport~     specific actions. These distinct clusters will describe potential biomechanical diagnoses~     that exist in groin pain patients. A biomechanics led rehabilitation program will return~     groin pain patients back to sport more quickly than previous rehabilitation programs without~     biomechanical diagnostic information.~      Brief protocol Participants will be recruited from patients with chronic athletic groin pain~     who present for investigation and rehabilitation at Sports Surgery Clinic, Ireland. A~     standardised clinical examination will be undertaken including range of motion assessment,~     pain provocation and load tolerance tests, and palpation.~      A Magnetic Resonance Image of the hip and groin region will then be undertaken and read by a~     consultant sports physician.~      Biomechanical assessment will include capturing of jumping, hopping and cutting mechanics~     through the use of three dimensional motion capture technology and force plates. Here~     reflective markers are placed on the skin at anatomical landmarks. These markers are picked~     up by the cameras and tracked at 200 frames per second. Participants will contact the force~     plate with their foot on undertaking the movements. Force and marker data will be combined to~     calculate joint angles and moments.~      Physical therapy assessment will include an assessment of functional movement, range of~     motion testing, adductor squeeze tests, strength assessment of hip and trunk.~     Physiotherapists will utilise three dimensional biomechanical data during cutting and landing~     to inform individualised rehabilitation. Rehabilitation will consist of movement control,~     whole body strength and power, linear running mechanics, multi-directional mechanics and~     conditioning sessions. Participants will have follow up physical therapy appointments~     approximately every two weeks. A hip and groin outcome score (HAGOS) will be used to monitor~     the morbidity and severity of the injury throughout the rehabilitation process.~      Once the physiotherapist determines that the patient is ready to return to play a~     biomechanical re-test will be undertaken.~   "
86263|NCT02437929|"~     This study aims to assess self reported procedural pain compared with background pain and~     evaluate pain intensity differences across six standard procedures. Besides, rescue and~     preventive treatments used to control procedural pain will be examined.~   "
86264|NCT02437916|"~     The purpose of this study is to evaluate the safety, pharmacokinetics, anti-tumor activity,~     and identify a tolerable dose of AMG 228 in subjects with advanced solid tumors.~   "
86271|NCT02437825|"~     Salivary fistulae have been the bane of surgical salvage in the era of primary chemoradiation~     for head and neck (H&N) cancers. The blameof prior chemoradiation tissue damage encouraged~     compensatory surgical techniques that focused on the insertion of non-irradiated tissue into~     the field. This study emphasizes a paradigm shift in the understanding and treatment of~     pharyngocutaneous fistulae. The detrimental effects of salivary enzymes on tissue healing and~     surgical anastomoses are addressed and novel treatment strategy is outlined.~   "
86272|NCT02437812|"~     Initially, the prospect of metformin as a neoplastic treatment was considered for~     malignancies of the prostate, colon and pancreas. However, only select clinical studies~     involving the use of metformin in the treatment of ovarian cancer have documented improved~     survival rates. Since no first line regimen has demonstrated compelling superiority in the~     management of advanced stage ovarian carcinoma, the combination of paclitaxel, carboplatin,~     and metformin is of particular interest given the triplet's prospect for achieving increased~     synergy without compromising patient tolerability.~   "
86273|NCT02437799|"~     BACKGROUND:~      Hypotension occurs commonly during spinal anaesthesia for caesarean section and may result in~     detrimental effects to the mother and foetus. A previous pilot study where images of the~     pulse oximeter waveform study were taken, found that the dicrotic wave moved away from the~     systolic wave during the onset of hypotension.~      AIMS:~      The investigators wish to download electronic data which describe the pulse oximeter pulse~     wave to more accurately assess movement of the diastolic wave relative to the systolic wave~     during spinal anaesthesia for caesarean section.~      METHODOLOGY:~      20 women undergoing caesarean section under spinal anaesthesia will be recruited by informed~     consent for this observational study. Data downloaded from the pulse oximeter will be~     analysed to identify movement of the dicrotic wave relative to the systolic wave and this~     will be related to changes in blood pressure.~      EXPECTED OUTCOMES:~      The investigators will establish best way to analyse changes in the pulse oximeter waveform~     and the relationship between changes in pulse oximeter waveform morphology and the onset of~     hypotension during spinal anaesthesia for caesarean section.~      IMPLICATIONS:~      Analysis of movement of the dicrotic wave could be used to anticipate and thus avoid severe~     hypotension during spinal anaesthesia for caesarean section.~   "
86274|NCT02437786|"~     The specific clinical trial is a part in which ALK- Abelló will directly work to explore~     human immunological mechanisms of SIT (observed after GRAZAX treatment).~   "
86275|NCT02437773|"~     Obsessive-compulsive disorder (OCD), characterized by intrusive thoughts (obsessions) and~     related behavioral rituals (compulsions), is a common psychiatric illness that often emerges~     in childhood and causes life-long disability in over 50% of patients. Psychological theory~     suggests that OCD symptoms are driven by a person's difficulty disengaging their feelings~     from simple tasks (e.g. washing hands, locking a door) due to excessive anxiety about~     performance errors. Cognitive behavioral therapy (CBT), the gold standard treatment for OCD,~     repeatedly exposes patients to their OCD-stressor until this anxiety is reduced. While CBT is~     typically more effective in teenagers than adults, patients from both age groups are usually~     left with residual symptoms, highlighting the need for better treatments. In this study, CBT~     will be studied in both teen-aged and adult patients. Two groups, both with childhood onset~     OCD, will be randomized to either CBT for OCD or stress management training (SMT), an active~     therapy but with minimal effects on OCD symptoms. The investigators will also study~     age-matched, healthy controls as comparison subjects.~      Before and after 12 weeks of CBT, all subjects will undergo functional Magnetic Resonance~     Imaging (fMRI) scans to see what regions of the brain become active when a concentration task~     is performed and how that activation is changed after CBT. The purpose of this study is to~     demonstrate the brain changes associated with CBT treatment and how differences in these~     changes in teenage compared to adult patients may drive differences in CBT response.~   "
86276|NCT02437760|"~     The tumor associated CA-125antigen for diagnosis and follow-up of ovarian cancer was well~     defined. Increased serum CA125 level may have many diagnoses other than ovarian cancer,~     including breast, colorectal and lung cancer. 80% lung cancer patients were diagnosed at~     advanced stage. Malignant pleural effusion secondary to lung cancer represented the condition~     of cancer cell involved pleura.~      The CA-125 level may reflect the extent of tumor involved in pleura (tumor burden), it could~     be correlated with the prognosis. This study was performed to examine the properties of~     CA-125 by measuring pleural and blood CA-125 levels in lung cancer with or without malignant~     pleural effusion; meanwhile to examine whether the rate of decline in CA 125 during primary~     therapy as a surrogate indicator for survival.~   "
86277|NCT02437747|"~     A study on the effect of locally delivered aloe vera gel as an adjunct to scaling and root~     planing in the treatment of chronic periodontitis patients with controlled type II diabetes~     mellitus.The evaluation of Plaque Index, Gingival Index, Probing Pocket Depth, Relative~     Attachment Level at baseline, 6 weeks and 3 months and Glycosylated heamoglobin at baseline~     and 3 months.~   "
86278|NCT02437734|"~     Disease in coronary arteries kills more people in the UK than any other cause. The~     investigators have developed a computer system ('VIRTU') which predicts blood pressure~     changes inside coronary arteries. This is important because;~        -  Doctors make better decisions regarding when and how to treat patients with coronary~          artery disease if they have these blood pressure measurements~        -  Currently, Doctors have to insert a metal wire inside the heart to measure artery~          pressures which is time-consuming and requires special equipment, staff, training and~          medicines.~      Although this invasive technique saves lives and money, more than 95% of patients do not~     receive the procedure or the benefits it provides.~      VIRTU provides a solution to this problem since it only needs X-ray pictures and does not~     require any wires, drugs, or additional time, equipment or staff. VIRTU has been tested and~     works but needs improving before it can be used in all patients.~      GOALS:~      Following, and compared with, our pilot project ((Modelling the significance of coronary~     artery disease, STH 15740) to:~        1. Improve VIRTU's accuracy.~        2. Improve VIRTU's speed.~        3. Test VIRTU in patients with more complicated coronary disease.~      One hundred patients will be recruited from angiography waiting lists and consented before~     attending for their angiography. The patients will be asked whether their angiogram pictures~     and pressure measurements maybe used as part of the data collection for this study. The data~     will be used to validate and develop VIRTU to make it 'patient-ready'. VIRTU will deliver all~     the advantages of the current invasive technique (i.e. reduced deaths, heart attacks and~     cost) but, is less invasive and usable in 100% patients.~   "
86279|NCT02437721|"~     The study is designed to show equivalence of an infant formula containing L-5-~     Methyltetrahydrofolate (MTHF) compared to a standard infant formula containing folic acid in~     respect to weight gain of healthy term infants receiving these infant formulae exclusively~     during the first 4 months of life. Healthy non breast fed infants will be randomized to~     receive either a standard infant formula with folic acid or a corresponding formula with MTHF~     instead of folic acid. Besides weight and length further anthropometric measures will be~     taken monthly from the age of 4 weeks to the age of 16 weeks and at the age 4 and 16 weeks~     blood samples will be taken for the determination of folate status and genotyping. As a~     reference the same measures will be taken in a group of breast fed infants, whose mothers`~     folate status will be determined as well.~   "
86280|NCT02437708|"~     This study evaluates the impact of autologous 'leucocyte and platelet rich fibrin' (L-PRF) on~     the periapical bone healing and further root development of infected immature permanent~     teeth. In the test group regenerative endodontic procedure (REP) is performed with L-PRF as~     scaffold, in the control group REP without L-PRF is performed .~   "
86281|NCT02437695|"~     Although a condition for surgery, robotic interventions applied with steep~     Trendelenburg-lithotomy (ST-L) position may cause positional injury and peripheral neuropathy~     if good position is not achieved on the operating table. This study will be a 7-year~     retrospective examination of postoperative positional injury (PPI) in patients undergoing~     robot-assisted radical prostatectomy (RARP) for prostate diagnosis.~   "
86282|NCT02437682|"~     The PASS test is only available and valid tool for the evaluation of persistent acid-related~     symptoms in patients receiving PPI therapy. There is lack of a validated Chines version of~     PASS questionnaire for the GERD patients with partial response to proton pump inhibitor~     (PPI). The English version of PASS test will be translated to traditional Chinese by using~     forward-backward procedure, and the Chinese version of PASS test will be validated its~     psychometric properties in Hong Kong population.~      Eligible subjects will be invited to administer questionnaires to evaluate the psychometric~     properties of the Chinese version of PASS test.~   "
86283|NCT02437669|"~     Intranasal hydromorphone has been shown to be effective in reducing acute pain in adults. It~     has not been previously studied in children, but may be a viable option for effectively and~     safely reducing pain in children by administering an analgesic by the intranasal route.~      This study will be a prospective, open-label pilot study of intranasal hydromorphone in~     children with moderate to severe acute pain presenting to the pediatric emergency department.~     The investigators aim to describe the amount of pain reduction associated with intranasal~     hydromorphone, and to determine the optimal dose of intranasal hydromorphone associated with~     a clinically meaningful improvement in acute pain.~   "
86284|NCT02437656|"~     Metformin is an oral antidiabetic of the biguanide class derived from galega officinalis.~     Historical cohort of patients with diabetes have shown that diabetics on Metformin had a~     better chance of survival than diabetics not on Metformin. These observations have led to in~     vitro studies of metformin on cancer cells. It was thus demonstrated that Metformin has~     anti-proliferative properties.~      The aim of our study is to evaluate the efficacy of metformin in combination with neoadjuvant~     radiochemotherapy in the treatment of locally advanced rectal cancer.~   "
86285|NCT02437643|"~     The purpose of the trial is to assess the effects of combining regular, generous intakes of~     high quality protein (primarily from dairy and other animal source proteins) with calorie~     restriction and low-intensity exercise on muscle quality and muscle adipose infiltration~     (along with bone mineral density [BMD] and a number of secondary outcomes) in frail, obese,~     older adults participating in a 6 month intervention. The investigators will compare these~     effects to those of a traditional control regimen of calorie restriction and low-intensity~     exercise over the same duration.~   "
86286|NCT02437630|"~     In this study the investigators aim to investigate the extent to which in patients with~     chronic obstructive pulmonary disease narrowing of the vocal cords causes a positive pressure~     within the airways thus improving airflow and lung function. This information will be~     captured in the upright and lying down positions and an estimate of the magnitude of the~     effect will be formed by offsetting the pressure by asking the patients to breathe using a~     commercially available device used to treat sleep apnoea called a CPAP machine. This is an~     observational study in which the observation of laryngeal aperture, and mouth and oesophageal~     pressure at differing levels of applied CPAP will be recorded for analysis in patients with~     COPD and in normal subjects without COPD. All will have the same measurements, observations,~     and interventions to allow us to observe and measure pressure, laryngeal aperture, and~     airflow .~   "
86287|NCT02437617|"~     The goal of this research study is to collect and test tumor tissue from patients with~     advanced cancers that may be enrolled in Phase 1 studies or other treatments. Researchers~     will study if the results from genetic testing can help researchers determine which therapy~     may prove more beneficial for a patient in the future.~   "
86288|NCT02437604|"~     Each patient will participate in the study for approximately 7 weeks. Participation will~     include a screening period of up to 21 days and 4 treatment periods; each consisting of a~     3-day/2-night inpatient period.~   "
86289|NCT02437591|"~     The purpose of this study is to investigate the plasma pharmacokinetics (PK) of fidaxomicin~     (FDX) and primary metabolite OP-1118 in Subjects with Inflammatory Bowel Disease (IBD) and C.~     difficile Infection (CDI).~      This study will also compare CDI clinical response to the microbiological response in terms~     of magnitude of reduction of C. difficile total viable count and spore count during treatment~     with FDX and if achieved; the time to microbial eradication; determine time to negative CDI~     toxin assay in stool specimens during treatment with FDX; assess the stool concentrations of~     FDX and metabolite OP-1118 throughout therapy; assess the length of hospital stay,~     readmissions and resource utilization for IBD patients receiving FDX; record the incidence~     and severity of Adverse Events (AEs) and document the impact of treatment on Quality of Life~     as measured by the changes in Short Inflammatory Bowel Disease Questionnaire (IBDQ) score.~   "
86299|NCT02437461|"~     This prospective randomised controlled single blind trial comparing the relapse rate in 6~     months for 20 mg versus 40 mg intraarticular triamcinolone hexacetonide (Lederspan®) for knee~     synovitis in patients with rheumatoid arthritis (RA) and psoriatic artritis (PsoA) is~     performed to find the optimal dose to use.~   "
86290|NCT02437578|"~     Today, it is evident that vitamin D has more widespread effects than the classical actions~     related to bone mineralization and calcium homeostasis. Vitamin D deficiency results in~     impaired reproductive performance in various species of animals, and recently the~     investigators have shown that the Vitamin D receptor (VDR), activating (CYP2R1, CYP27A1,~     CYP27B1) and inactivating (CYP24A1) enzymes are expressed in the human testis, epididymis,~     seminal vesicle, prostate and spermatozoa. Functional studies showed that activated vitamin D~     increases intracellular calcium and sperm motility in mature spermatozoa, and hence may be~     important not only for spermatogenesis but also for sperm function. Any test that might~     assist in guiding the treatment of the infertile couple would be beneficial both for most~     infertile couples and the society in general. The fact that vitamin D may play a role for~     human semen quality are now being tested clinically. If vitamin D supplementation proves~     efficient this opens for the first time for a causal, safe and cheap treatment of at least~     some cases of idiopathic impaired semen quality. This may also have consequences in the in~     vitro setting as activated vitamin D may be used to select high quality sperm during assisted~     reproductive techniques. The presence of the vitamin D receptor and vitamin D metabolizing~     enzyme CYP24A1 in particular is able to discriminate spermatozoa from normal and infertile~     men. CYP24A1 is expressed at the annulus of normal sperm, but it is virtually absent from~     spermatozoa from infertile men. This indicates that CYP24A1 expression may assist in~     predicting the chance of success by using insemination (IUI), IVF or ICSI. CYP24A1 expression~     is induced by activated vitamin D, which indicates that other VDR activated genes also may~     serve as positive predictive markers of fertility. In addition, vitamin D metabolites and~     other factors in the female reproductive tract will be measured to determine if they alone or~     in combination with other markers can determine whether the best solution for the infertile~     couple would be to do IUI, IVF, or ICSI. The suggested clinical trial may therefore be able~     to evaluate several secondary endpoints in addition to CYP24A1 in our search for predictive~     markers for fertilization. For instance several biomarkers in serum, seminal plasma or~     follicular fluid in conjunction with genetic polymorphisms in several genes important for~     reproductive function.~   "
86291|NCT02437565|"~     Stainless steel crowns are arguably the most successful posterior restorations in primary~     teeth and have been so for more than 50 years. Stainless steel crowns offer durability and~     success rates in excess of 95% making them the restoration of choice for posterior primary~     teeth in children treated under general anesthesia.~      Failures of stainless steel crowns placed on primary teeth have been documented using several~     criteria including marginal adaptation, recurrent caries, abscess formation or root~     resorption, loss of the crown due to faulty retention and even perforation of the crown .~     Despite the probability that factors such as root resorption and failure of endodontic~     treatment could be due to traumatic occlusion, surprisingly little evidence is available in~     literature on the attempts made to check or evaluate the occlusion of stainless steel crowns~     placed under general anesthesia The aim of this study was to compare the time taken for~     placement and the overall success of bilateral multiple stainless crowns placed under general~     anesthesia using an occlusal index and compare them to crowns placed without such an index,~     using a randomized control study design~   "
86292|NCT02437552|"~     The prevalence of heart diseases has increased significantly in recent years and it is a~     health public problem due to an increased risk of death by several reasons. A cardiac surgery~     is an alternative of treatment for critical injuries heart valves and coronaries arteries.~     Changes in respiratory system resulting from cardiac surgery are well established and include~     a reduced functional capacity due post-surgical pain, causing increased respiratory function~     and increased oxygen consumption . The exercises with the cycle ergometer in phase I of~     cardiac rehabilitation can improve peripheral muscle strength, functional capacity and~     perception of dyspnea when used postoperatively and there are speculations if an earlier~     carried out can contribute to a better postoperative evolution of patients, but these~     benefits in phase I of the Rehabilitation Cardiac are not well defined in the literature.~     Objective: To evaluate the exercises effects with ergometer cycle in the postoperative course~     of patients undergoing cardiac surgery. Method: Patients will be recruited the cardiac~     surgery service of Polyclinic Pato Branco in the city of Pato Branco in state of Paraná, of~     both sexes, appropriate for the inclusion criteria, which will be evaluated by pulmonary~     function tests (strength of respiratory muscles, submaximal exercise test, dyspnea scales,~     laboratories tests and radiological exam). All patients will be randomly assigned for one of~     two groups: the control group (Conventional treatment) and rehabilitation group (conventional~     treatment +cycle ergometer), for about 7 days at postoperative period. Patients will be~     reevaluated on the third postoperative day and at discharge. Clinical evolution data will be~     collected from the records and notes of the medical staff and monitoring physiotherapist.~   "
86293|NCT02437539|"~     The primary objective of the study is to test a new radiotracer called 68Ga-NOTA-AE105 for~     PET imaging of uPAR (urokinase plasminogen activator receptor). The tracer has the potential~     of identifying the invasive cancer phenotype, thereby distinguishing between aggressive and~     less aggressive tumors. This is a first in human study to test the radiotracer in cancer~     patients. The biodistribution and tumor uptake will be evaluated by repeated PET imaging (10~     minutes, 1 hour and 2 hours post injection).~   "
86294|NCT02437526|"~     This study is designed to determine if individual patients with HIV infection have been cured~     of the infection. To do this, antiretroviral therapy is discontinued under close medical~     supervision and the patient monitored over time for reactivation of infection.~   "
86295|NCT02437513|"~     Laryngeal dysfunction is a problem that affects many patients after laryngeal cancer therapy~     (surgery or radio/chemotherapy). Laryngeal dysfunction is associated with higher incidences~     of aspiration and respiratory tract complications such as aspiration pneumonia. Current~     standard of care treatment to reduce the consequences of aspiration is often a tracheostomy~     which has its own risks and complications. The proposed study aims to describe the~     performance of a new CE marked medical implant, the NewBreez, in protecting the patient's~     airways from aspiration.~   "
86296|NCT02437500|"~     This is an open-label study for patients who have a recurrence of Clostridium difficile~     infection in the first 8 weeks of participation in the SERES-004 study. As the SERES-004~     study has completed enrollment, SERES-005 was amended to allow expanded access in accordance~     with 21 CFR 312.315 to SER-109 for patients with recurrent CDI who would have qualified for~     the SERES-004 study.~   "
86297|NCT02437487|"~     The study will involve administering the study drug as a single dose of study drug or~     placebo. This study is designed to demonstrate the superiority of the experimental drug~     versus placebo in adult patients with recurrent CDI.~   "
86298|NCT02437474|"~     The purposes of this study are~        -  to test the hypothesis that elimination or reduction of dietary animal proteins leads to~          an improved prognosis in tumor patients~        -  to estimate the effect size and thus to enable sample size calculations for further~          studies~        -  to test the feasibility and tolerance of different diets, especially a vegan diet, in~          cancer patients and to proof that a vegan diet does not lead to a deterioration of~          health, tumor progression or to malnutrition~        -  to test the online platform as a study platform~        -  to test validity of self reported and online generated data~   "
86301|NCT02437435|"~     Ivanovski shows that by studying the vascular impedance can calculate the optimal uterine~     receptivity in IVF. A reduced vascular resistance and increased blood flow rate improves the~     chance of pregnancy.~      Dr. Luis T. Mercé says: After evaluating 40 cycles of IVF (In Vitro Fertilization) have~     found that the pregnancy rates increases with increasing endometrial volume. It has also~     advocated that the endometrial blood flow better reflects uterine receptivity, since the~     endometrium is where will take place the embryo implantation. Merce also claims to have found~     that the pregnancy rate increases with increasing endometrial volume and no pregnancies were~     achieved with endometrial volume less than 3 ml.~      These statements motivate us to perform a research project to monitor changes that occur in~     the uterine endometrial vascularization and subendomertial vascularization after applying a~     manual physiotherapic technique in menopausal women.~      Various authors report that by osteopathic techniques applied on visceral structures,~     vascular flow rate of the treated bodies increased.~      In the literature there are not articles on the subject at hand, but there are references to~     the manual techniques in the treatment of women with infertility where they state that the~     manual action for lymphatic congestion in the pelvic region facilitates pregnancy in women~     infertile.~      The practice of visceral osteopathy offers the possibility of accessing the treatment of~     uterine functional disorders, as well as structures such as uterine ligaments. They influence~     the fluidic efficiency of uterine arteriovenous system. According to Salamon E., W. Zhu and~     Stefano GB., provides enough tools to improve the movement of fluids and uterine~     vascularization.~   "
86302|NCT02437422|"~     A Phase Ib, Open-Label, Single Arm Study to Assess the Safety, Pharmacokinetics, and Impact~     on Humoral Sensitization of SANGUINATE Infusion in Patients with End Stage Renal Disease~     (ESRD).~   "
86303|NCT02437409|"~     ARTESp is a prospective multicenter study in which the pREset thrombectomy system (phenox~     GmbH* Germany) will be examined. The effectiveness, safety and the long-term success when~     using the pREset to treat acute occlusions of cerebral vessels will be analyzed.~      *German: Gesellschaft mit beschränkter Haftung, limited liability company~   "
86304|NCT02437396|"~     The objective of this study is to evaluate oxidative stress and/or inflammation in patients~     with Gaucher disease type I using a series of biomarkers and correlate with measurements of~     currently used diagnostic biomarkers.~   "
86305|NCT02437383|"~     Purpose:~      Primary: To evaluate the efficacy of extended-release propranolol compared to placebo in the~     reduction of a pain index in patients with temporomandibular disorder (TMD).~      Secondary: To determine if extended-release propranolol efficacy varies according to~     participants' catechol-O-methyltransferase (COMT) genetic polymorphisms and to investigate~     the efficacy of extended-release propranolol compared with placebo using secondary endpoints.~      Exploratory: To investigate whether the effecacy of extended-release propranolol in the~     reduction of the pain index varies according to participants' polymorphisms in 3 other~     genetic regions and according to various phenotypic characteristics.~      Participants:~      200 patients with chronic TMD will be randomly assigned, in a 1:1 parallel, double-blind~     fashion, to receive either extended-release propranolol or placebo at one of three study~     sites: University of North Carolina-Chapel Hill School of Dentistry; University of~     Florida-Gainesville College of Dentistry; and the State University of New York at Buffalo~     School of Dental Medicine.~      Procedures (methods):~      Randomization will be to either propranolol or placebo. The 10-week study treatment period is~     divided into: 1 week of drug titration, 8 weeks of drug maintenance, and 1 week of drug~     tapering. The titration and tapering doses are 60 mg (capsules) once per day orally; the~     maintenance dose is 60 mg twice per day orally. Participants will attend 6 clinic visits over~     12-15 weeks as follows: screening and baseline visit (Visit [V] 0, 7-21 days prior to V1);~     randomization and start of treatment (titration) (V1, study day 0); maintenance visit 2 (V2,~     1 week post-randomization, study day 7+3); maintenance visit 3 (V3, 5 weeks~     post-randomization, study day 35 +/- 7); tapering visit (V4, 9 weeks post-randomization,~     study day 63 +/- 7); and tapering visit 5 (V5, 11 weeks post-randomization and 1 week after~     drug tapering ends, study day 77 +/- 7). Depending on the visit, procedures will include:~     reviews of medical history, weekly alcohol consumption, concomitant therapies and~     medications, adverse events, compliance, and eligibility; administration/review of~     questionnaires; blood draw; pregnancy test in women of childbearing potential; and dispensing~     of study drug.~   "
86306|NCT02437370|"~     This phase I trial studies the side effects and best dose of pembrolizumab when given~     together with docetaxel or gemcitabine hydrochloride in treating patients with previously~     treated urothelial cancer that has spread to other places in the body and usually cannot be~     cured or controlled with treatment (advanced) or that has spread from the primary site (place~     where it started) to other places in the body (metastatic). Monoclonal antibodies, such as~     pembrolizumab, may block tumor growth in different ways by targeting certain cells. Drugs~     used in chemotherapy, such as docetaxel and gemcitabine hydrochloride, work in different ways~     to stop the growth of tumor cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Giving pembrolizumab together with docetaxel or~     gemcitabine hydrochloride may be a better treatment for urothelial cancer.~   "
86307|NCT02437357|"~     The purpose of the present randomized-controlled trial is to investigate the efficacy of~     Metacognitive Training for Depression (D-MCT), a new low-threshold, modular group~     intervention.~   "
86308|NCT02437344|"~     Opioid dependence is a substantial problem associated with significant morbidity and~     mortality. Extended-release naltrexone has been found effective at reducing opioid use and~     maintaining abstinence, but its use has been limited by the difficulties encountered with~     treatment initiation, which involves detoxification from opioids and oral naltrexone~     titration. Improving the likelihood of a successful transition to naltrexone is therefore an~     important public health goal.~      N-methyl-D-aspartate receptor (NMDA) antagonism has been found to alleviate the signs and~     symptoms of withdrawal from opioids, as well as to address adaptations associated with~     chronic opioid use, such as opioid-induced hyperalgesia (increased pain sensitivity). These~     benefits may persist for at least 72 hours after a single dose. NMDA antagonism may therefore~     facilitate a rapid transition to naltrexone by reducing discomfort, improving motivation, and~     ameliorating adaptations associated with drug dependence, such as craving and arousal.~      The purpose of this trial is to assess the feasibility of NMDA antagonist-assisted naltrexone~     initiation in opioid dependent individuals. After administration of extended-release~     naltrexone, participants will be followed for 4 weeks, and transitioned to appropriate care~     subsequently (oral naltrexone, extended-release naltrexone).~   "
86309|NCT02437331|"~     The purpose of this study is to explore the experience in being with advanced Heart failure~     patients.~   "
86310|NCT02437318|"~     To determine whether treatment with alpelisib plus fulvestrant prolongs progression-free~     survival compared to fulvestrant and placebo in men and postmenopausal women with hormone~     receptor positive (HR+), HER2-negative advanced breast cancer, who received prior treatment~     with an Aromatase Inhibitor either as (neo)adjuvant or for advanced disease.~   "
86311|NCT02437305|"~     This study will examine the effectiveness of a targeted, health literate educational~     intervention for people of color compared to a standard melanoma education pamphlet for~     increasing knowledge and promoting early melanoma detection. It is hypothesized that people~     of color are less aware of their risk for developing melanoma and that a targeted educational~     intervention will help increase knowledge and promote early melanoma detection especially in~     individuals with low health literacy.~   "
86312|NCT02437292|"~     The purpose of this study is to determine the effect of ischemic compression with stretching~     on pain related parameters including pain intensity, pressure pain threshold, anxiety,~     cervical range of motion and patient satisfaction in patients with scapular pain associated~     with myofascial trigger point.~   "
86313|NCT02437279|"~     This is a two-arm Phase 1b feasibility trial consisting of 20 patients receiving the~     combination of ipilimumab+nivolumab, either adjuvant, or split neo-adjuvant and adjuvant.~   "
86314|NCT02437266|"~     The purpose of this study is to determine the effect of scapular mobilization on pain related~     parameters including pain intensity, pressure pain threshold, muscle tension, anxiety,~     Scapular range of motion, patient satisfaction in patients with scapular pain associated with~     myofascial trigger point:~   "
86315|NCT02437253|"~     The purpose of the study is to collect preliminary data on whether the drug adalimumab (also~     called Humira) can decrease pain and stiffness, improve quality of life, and is safe in~     people with mucopolysaccharidosis type I, II, or VI. In this study people will be randomly~     assigned to one of two groups. One group will be treated with adalimumab the first 16 weeks~     of the study and then with a saline injection for the last 16 weeks of the study. The other~     group will start with the saline injection for 16 weeks and then switch to adalimumab for the~     last 16 weeks. The study subject and the study doctor and study coordinator will not know~     what group a subject is in until the study is done. Adalimumab is given as an injection, just~     under the skin, every 2 weeks. Both groups will have blood drawn at a screening visit, and~     then 7 more times over the 32 week study. There will be safety labs done (liver and immune~     function tests). Other safety tests include a chest X-ray and screening for tuberculosis~     exposure - these will be done at the screening visit and later in the study if there is~     concern for tuberculosis exposure or a persistent cough. The following will also be done at~     screening, the first, middle, and last study visits: 1) a pregnancy test in all girls 8 and~     older, 2) questionnaires that ask about pain, how MPS impacts social and physical function,~     and other quality of life questions, 3) height and weight. Finally, a physical exam, that~     includes for children and adolescents a check of where they are in puberty, will be done by a~     study physician at the first, middle, and last visits. There are risks to taking adalimumab~     that include redness and pain where the injection is given, a decreased ability to fight off~     infections, and others. The safety tests are designed to identify and decrease the risk~     associated with adalimumab. The study physicians believe that the potential benefit of~     adalimumab on pain, quality of life, and other MPS related problems outweigh the potential~     risks of treatment.~   "
86316|NCT02437240|"~     The purpose of this clinical trial is to evaluate the effect of pilates-based cardiopulmonary~     physical therapy (CPT) for in-patients after cardiac surgery.~   "
86317|NCT02437227|"~     The study is a first in man, dose escalation study to evaluate the safety, tolerability and~     how the drug works in the body in patients with all solid tumours. The aim of this study is~     to determine the most effective dose of the study drug that can then be further investigated~     in patients with advanced melanoma.~   "
86318|NCT02437214|"~     A single blinded controlled trial to determine if an intervention of listening to nursery~     songs with integrated heart beat sounds results in changes in anxiety level in infants and~     young children less than four years of age in an emergent setting.~   "
86319|NCT02437201|"~     Previous studies indicated high frequency of abuse in families and its consequences.~     Considering the importance of interventions such as educational interventions, in order to~     increase women's abilities to prevent abusive behaviors, the current research aims to~     determine the impact of an Liberty program on prevention of violence against women and~     propose solutions for less damages and consequences.~   "
86320|NCT02437188|"~     A large number of veterans suffer from distress-based conditions, such as anxiety and~     depression, putting them at high risk of experiencing persistent pain and prolonged opioid~     use following surgery. These connections are based on strong and consistent evidence from the~     literature and our preliminary data. The proposed study adds a 1-day workshop of Acceptance~     and Commitment Therapy (ACT), followed by an individual booster session, to treatment as~     usual (TAU) to reduce veterans' risk of persistent pain and prolonged opioid use following~     surgery. ACT has been shown to be effective in reducing chronic pain, anxiety and depression.~      This pilot study will establish the feasibility and preliminary efficacy of incorporating ACT~     into treatment as usual (TAU) to preoperatively target distress-based risk factors. Aim 1 is~     to establish the feasibility of successfully delivering ACT to at-risk veterans before and~     after surgery. Aim 2 is to test the preliminary efficacy of ACT on the length and/or amount~     of pain and opioid use after surgery. Veterans who are anxious or depressed before surgery~     will be randomly assigned to receive ACT plus TAU or TAU. Outcomes between the two groups~     will be compared. Aim 3 is to see if PROMIS modules, developed by the National Institute of~     Health, are useful for assessing pain and other symptoms in veterans. Findings from this~     study will be used to inform the design and implementation of a larger, well controlled,~     randomized clinical trial that will evaluate the efficacy of ACT plus TAU for at-risk~     veterans.~      This study will take place at the Iowa City VA Health Care System (VAMC). Veterans scheduled~     for orthopedic or open abdominal surgery in 1 to 3 months who score high for anxiety or~     depression will be randomly assigned to attend a 1-day ACT workshop preoperatively, with an~     individualize booster session postoperatively, or to have TAU. Veterans who receive ACT and~     trainers who provide the treatment will be interviewed to identify barriers and facilitators~     to providing ACT to at-risk veterans before and after surgery. Other primarily outcomes are~     pain and opioid use after surgery. Factors that may affect these outcomes will also be~     measured, including anxiety, depression, substance use disorder, post-traumatic stress~     disorder, and use of other pain meds.~      The investigators expect to gain important knowledge about ways to best include ACT as part~     of routine care for veterans requiring surgery and about the preliminary efficacy of ACT for~     the prevention of persistent pain and prolonged opioid use following surgery.~   "
86321|NCT02437175|"~     The primary objective of this pilot study is to evaluate the efficacy of trace elements,~     versus placebo, on the reduction of pain in endometriosis of an American Fertility Society~     (AFSr) score of 2 to 4, combined or not to an adenomyosis, during a chronic treatment of 4~     months.~   "
86322|NCT02437162|"~     The purpose of this study is to assess the efficacy of ustekinumab, in adult participants~     with active radiographic axial spondyloarthritis (AxSpA), who are naive to anti-TNF alpha~     agents, as measured by the reduction in signs and symptoms of radiographic AxSpA.~   "
86323|NCT02437149|"~     The study will measure the effectiveness of a distracted driving campaign in the emergency~     department in teenagers, 15 to 18 years old, to determine if it changes their attitudes~     towards texting while driving. It will also assess previous knowledge and behaviors in this~     age group, regarding distracted driving and what educational tool (power point vs. videos vs.~     brochure) has the most impact changing the attitudes towards texting and driving.~   "
86324|NCT02437136|"~     The purpose of this study is to determine the safety and tolerability of entinostat used in~     combination with pembrolizumab in patients with Non-small Cell Lung Cancer. Additionally the~     purpose of the study is to assess how effective entinostat and pembrolizumab are in~     combination in patients with Non-small Cell Lung Cancer, Melanoma, and Mismatch-Repair~     Proficient Colorectal Cancer~   "
86638|NCT02433041|"~     The purpose of this study is to find out whether postoperative delirium can be more properly~     prevented by the combination of determined preventive agents in past studies. Further on the~     investigators measure pre- and postoperative cortisol, neuron specific enolase (NSE) and~     S-100beta levels.~   "
86325|NCT02437123|"~     This study will examine the effect of a culturally-safe two-way supportive text message~     intervention to reduce HIV vulnerability among young Indigenous people who use illicit drugs~     in a community-based setting.~      The study is nested within The Cedar Project, an ongoing cohort study addressing HIV and~     Hepatitis C vulnerability among young Indigenous people who use drugs in Vancouver and Prince~     George, British Columbia, Canada. Indigenous collaborators and investigators, collectively~     known as the Cedar Project Partnership, govern the entire research process.~      A stratified Zelen pre-randomized design will be used to identify a random selection of~     cohort members to be offered the Cedar Project mHealth intervention with consent.~     Participants in the intervention arm will receive a package of supports, including a mobile~     phone and long-distance plan, weekly two-way supportive text messaging via the WelTel~     platform, and support from Cedar Advocates. Those drawn from the cohort study population as~     the comparison group will continue on in the usual Cedar Project study under its existing~     informed consent with no change whatsoever to their participation in the overall study.~      The main outcome is an HIV propensity score, assessed at six months and one year. Secondary~     outcomes include HIV risk, resilience, access to drug-related services, psychological~     distress, and connection to culture measured at six months and one year. Primary analysis is~     by intention to treat.~   "
86326|NCT02437110|"~     Background:~      - Some people with Amyotrophic Lateral Sclerosis (ALS) have a high level of the virus HERV-K~     in their blood. Researchers do not think this virus causes ALS. But they don t know why some~     people with ALS have a high level of it. They want to know if HERV-K can be suppressed by~     drugs that are used to treat HIV infection.~      Objectives:~      - To learn how drugs usually taken for HIV infection affect people with Amyotrophic Lateral~     Sclerosis (ALS).~      Eligibility:~      - Adults at least 18 years old with ALS and high levels of HERV-K but no HIV.~      Design:~        -  Participants will be screened with medical history, physical exam, and blood and~          breathing tests.~        -  Visit 2: participants will have medical history, questionnaires, and blood drawn. Their~          strength will be tested by pushing on a machine. They will blow into a tube that~          measures the air they can hold in their lungs.~        -  After Visit 2, participants will start taking the 4 study drugs twice a day.~        -  Participants will have study visits at Weeks 1, 2, and 4, then every 4 weeks until Week~          36. They will be asked how they are feeling and have an exam and blood drawn. At 2~          visits, they will have tests of strength, breathing, and their ALS symptoms. Some visits~          may be done at their ALS doctor s office.~        -  At Week 24, they will stop taking the study drugs.~        -  After the Week 36 visit, their participation is finished.~   "
86327|NCT02437097|"~     Many studies have examined the effects of aerobic exercise and playing video games effects on~     cognitive performance, which results of which have shown to increase cognitive performance.~     Presently, there is limited research regarding the effects of the combination of gaming and~     exercise on cognitive performance. The purpose of our study is to investigate the effects of~     playing video games, aerobic exercise, and a combination of gaming and aerobic exercise on~     cognitive performance. Forty healthy subjects, males and females (18-30 years old) who~     perform moderate exercise at least two times a week will comprise our sample. The study will~     be a randomized clinical trial with four independent variables: playing video games, aerobic~     exercise, a combination of simultaneous gaming and aerobic exercise and a control condition.~     Aerobic exercise will be performed at an intensity of 60 to 70% of maximum heart rate on a~     Monarch Lower Body Ergometer. Brain Age Game: Train Your Brain in Minutes a Day! will be~     played on Nintendo 3DS. Executive function will be measured using the Stroop test and Trails~     B pre and posttest. Analysis of variance for Stroop test and Trails B will be used. In the~     event of significant F statistics, a post hoc test analysis will be used. The investigators~     hypothesize a combination of aerobic exercise and simultaneous gaming will produce the~     greatest increase in cognitive performance. Furthermore, these beneficial changes can be~     utilized in rehabilitation protocols designed to improve cognitive functioning.~   "
86328|NCT02437084|"~     There is general agreement that statin-treatment of patients with high cholesterol can~     increase the incidence of type 2 diabetes (T2DM) in some individuals. This research proposal~     will study what metabolic characteristics and variables (for example high cholesterol or high~     triglycerides or both) will identify those people at highest risk of statin-induced T2DM. The~     investigators will evaluate how the medication atorvastatin (trade name Lipitor) works in~     regards to its effect on insulin action and insulin sensitivity to help further understand~     the possible cause of the increased occurrences of T2DM in people who are at risk for T2DM.~      Under Dr. Snyder, a Co-director of the study, samples will be collected for integrated~     Personal Omics Profiling (iPOP), a monitoring approach developed by Dr. Snyder and his~     research colleagues. The investigators propose to analyze iPOP of individuals who participate~     in this study during and after taking the statin. In this pilot study, analysis will be done~     on previously-known drug effectiveness but also untargeted drug's effectiveness, (other~     unknown benefits this medication may have) and drug effects such as those seen in some~     participants when given a statin. The hope then is to obtain a better understanding of how to~     perform a personal omics profile when taking drugs, which would lead to develop better use of~     drugs.~   "
86329|NCT02437071|"~     The radiation therapy or ablation that the patient received as standard therapy treated only~     the tumors that were radiated or ablated. Radiation therapy or ablation plus pembrolizumab~     might lead to a stronger immune response that may control or destroy tumors that did not~     receive radiation therapy or ablation. The purpose of this study is to find out what effects,~     good and/or bad, pembrolizumab has on the patient, and the cancer that did not receive~     radiation therapy or ablation.~   "
86347|NCT02436837|"~     Background:~      Taking into consideration the ongoing inversion of the population pyramid and the limitations~     and medical conditions, which predispose to episodes of falling among elderly people, the~     implementation of exercises and physical treatments capable of promoting postural balance in~     the group studied is made necessary.~      Objectives:~      Assess the influence of the electronic platform Kinect Sensor® (KS) as a tool in the~     treatment of postural balance in elderly individuals. Method: The study included 10 elderly~     (60 to 70 years old) and 10 young (20 to 30 years old) individuals. Treatment protocol~     composed of five weeks with sessions performed twice a week with application of KS. Initial~     and final evaluation included static and dynamic balance instruments: Berg Balance scale and~     Timed up and Go and Romberg Tandem tests.~   "
86330|NCT02437058|"~     The scales measuring the severity of acute decompensate heart failure (ADHF) in emergency~     departments have not achieved an adequate discriminative ability for decision making.~     Objectives: 1) Identify baseline variables, and evolutionary variables that may provide a~     good predictive ability of the model.2) Create and validate clinical predictive rules of~     mortality during admission/a week after ED visit in those discharged from ED, 30 and 60 days~     after ED visit as well as identify predicitive factors of short-term readmission (90~     days)Design: Prospective cohort study. The sociodemographics and clinical variables will be~     collected from emergency medical records to identify predictors. Outcome variables and~     evolution of variables will be collected from hospital medical records / ambulatory during~     admission and up to 90 days after the episode of ADHF. Baseline predictors and evolutionary~     variables will be identified through logistic regression models using 60% of the final~     sample. The models that best fit will be applied in 40% of the sample to assess the~     predictive validity of this scale.~   "
86331|NCT02437045|"~     Infections of the blood are extremely serious and require intravenous antibiotic treatment.~     When the infection results from antibiotic resistant bacteria, the choice of antibiotic is an~     extremely important decision. Some types of bacteria produce enzymes that may inactivate~     essential antibiotics, related to penicillin, called 'beta-lactams'. Furthermore high level~     production of these enzymes can occur during therapy and lead to clinical failure, even when~     an antibiotic appears effective by laboratory testing. However, this risk of this occurring~     in clinical practice has only been well described in a limited range of antibiotic classes in~     a type of bacteria called Enterobacter. There is currently uncertainty as to whether a~     commonly used, and highly effective antibiotic, called piperacillin-tazobactam is subject to~     the same risk of resistance developing while on treatment. Infections caused by Enterobacter~     (and other bacteria with similar resistance mechanisms) are often treated with an alternative~     drug called meropenem (a carbapenem antibiotic), which is effective but has an extremely~     broad-spectrum of activity. Excessive use of carbapenems is driving further resistance to~     this antibiotic class - which represent our 'lastline' of antibiotic defence. As such, we~     need studies to help us see whether alternatives to meropenem are an effective and safe~     choice. No study has ever directly tested whether these two antibiotics have the same~     effectiveness for this type of infection. The purpose of this study is to randomly assign~     patients with blood infection caused by Enterobacter or related bacteria to either meropenem~     or piperacillin/tazobactam in order to test whether these antibiotics have similar~     effectiveness.~   "
86332|NCT02437032|"~     A key challenge facing reproductive biologists is the integration of the knowledge about~     oocyte-secreted factors into coherent physiological mechanisms of how oocytes govern~     folliculogenesis, cumulus cell function, and oocyte and embryo development. Although key~     oocyte-secreted factors have been identified, understanding their modes of action is~     complicated by multiple interactions between maternal and oocyte signaling molecules, as well~     as the constantly changing state of physical interactions between the oocyte and its~     companion somatic cells during folliculogenesis. Thus, the investigators study aimed to~     determine if there is any relationship between different gonadotropin preparations and~     oocyte-secreted factor secretion, the endocrine pattern in follicular fluid, and the~     apoptotic rate in cumulus cells during controlled ovarian stimulation.~   "
86333|NCT02437019|"~     The purpose of this study is to provide early access to Ibrutinib treatment for participants~     with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) and collect additional safety~     data while the medication is not commercially available.~   "
86334|NCT02437006|"~     This is a two-stage study. In the first stage, 30 subjects with stroke (onset > 2 weeks) are~     recruited, and they are assessed and recorded with clinical characteristics, sympathetic~     nerve testing, and twice symptom-limit exercise capacity tests. The second stage would~     recruited 90 subjects with stroke (onset>2 weeks), and they are randomized to one of three~     groups (control, low-intensity, high-intensity). They are evaluated before and after the~     four-week interval with clinical characteristics and twice symptom-limit exercise capacity~     tests (baseline and after four-week training) .~   "
86335|NCT02436993|"~     The purpose of this phase II is to study the efficacy and toxicity of carboplatin and~     paclitaxel with pertuzumab and trastuzumab in HER2 positive and carboplatin and paclitaxel~     with bevacizumab in HER2 negative in the neoadjuvant setting for the treatment of breast~     cancer.~   "
86336|NCT02436980|"~     OBJECTIVE:Purpose of this study is to set forth the sedative efficacy and effects on early~     period cognitive functions of two premedication drugs used for ERCP (Endoscopic retrograde~     cholangiopancreatography) METHODS:This randomized and double blind study was performed with~     forty (18-70 of age) ASA I-III risk group patients for who elective ERCP was planned.~     Cognitive functions of patients were determined by mini-mental test (MMT). 0.5 mg/kg~     midazolam or 1mg/kg tramadol drop was administered orally before intervention to patients who~     were randomly divided into two premedication groups.~      Vital signs,BIS (Bispectral index), mRSS (modified Ramsay Sedation scale), NRS (numeric~     rating scale ) was evaluated. If MMT (mini-mental test) was ≤ 23 at 60th minute it was~     considered as cognitive impairment. Recovery period, post-procedure state of cognitive~     function at 60th minute were recorded.~   "
86337|NCT02436967|"~     Classification of carotid plaque vessel wall changes in carotid stenosis accordingly to AHA~     classification (American Heart Association)- comparison between histology and CT. The CT is~     performed with a fast kVp-switching dual energy technique.~      To compare the ability to detect iodine contrast enhancement in the carotid plaque compared~     with 3T MRI with gadolinium.~   "
86348|NCT02436824|"~     The objectives of this study are to examine the safety, tolerability, and efficacy of~     repeated topical administration of AB001 topical patches for the treatment of chronic low~     back pain.~   "
86375|NCT02436473|"~     The purpose of this study is to evaluate the effect of the test toothpaste containing 1150~     parts per million (ppm) of fluoride (F) on the mineral content of demineralized enamel~     specimens, in an in situ caries model system, by comparing the differences in net~     remineralization change (ΔM) following use of the test toothpaste with a fluoride free (0 ppm~     F) reference control toothpaste.~   "
86376|NCT02436460|"~     This study is to establish the safety, determine if there is an improvement in steroid~     refractory acute graft-vs-host disease (aGvHD) compared to historical cohorts, and determine~     the changes of aGvHD-associated T-cell clones in patients with steroid-refractory aGVHD~     following allogeneic hematopoietic cell transplantation administered AbGn-168H once weekly~     for 4 weeks.~   "
86338|NCT02436954|"~     While few studies have determined the optimal intra-abdominal CO2 insufflation pressure to~     achieve optimal surgical condition during LCs with deep-NMB and moderate-NMB in laparoscopic~     cholecystectomy (LC), previous studies suggested that the use of deep neuromuscular blockade~     (deep-NMB) can improve surgical condition and reduce the pressure for CO2 insufflation to~     achieve optimal surgical space condition.~      this difference in the pressure of intra-abdominal CO2 insufflation due to different~     strategies employing deep-NMB and moderate-NMB for LC may produce possible difference in~     patient's respiratory pattern and cerebral oxygenation. Although previous study (studies)~     showed that intra-abdominal CO2 insufflation (10-12 mmHg) decreases cerebral oxy-hemoglobin~     (HbO2) and total Hb measured by near-infrared spectroscopy (NIRS) during laparoscopic~     cholecystectomy (LC), few studies have speculated possible impact of different degree of NMB~     and intra-abdominal CO2 insufflation pressure on patient's cardiorespiratory profile and~     cerebral oxygenation, so far.~      The present study determines and compares the changes CO2 absorption and cerebral oxygenation~     (cerebral perfusion) after applying CO2 insufflation with different intra-peritoneal pressure~     8 vs 12 mmHg during deep-NMB.~   "
86339|NCT02436941|"~     For most cancers, long-term follow-up is the best measure of treatment effectiveness. The~     Department of Radiation Medicine at Loma Linda University Medical Center operates the James~     M. Slater, M.D., Proton Treatment and Research Center, the world's first hospital-based~     proton treatment facility. Patients have been treated at the Center since 1990. Radiation~     treatment has been expanded and refined since the Center's opening, and these changes have~     been based primarily on outcomes seen and evaluated in long-term follow-up.~      The Radiation Medicine Patient Registry (a multi-year database), which began as an~     IRB-approved study in 2003, including detailed follow-up of study data collected from 1990~     and onward, is designed to track all medical information from patients treated with proton~     therapy and/or conventional X-ray therapy at Loma Linda University Medical Center.~     Information gathered from patients treated years or even decades ago helps to determine the~     most effective use of proton and conventional radiation in caring for patients with cancers~     and other diseases.~   "
86340|NCT02436928|"~     This study aims to evaluate the safety and immunogenicity of an inactivated cell culture~     derived H7N9 vaccine in healthy adult subjects.~   "
86341|NCT02436915|"~     The objective of this study is to determine whether augmentation of prefrontal brain~     excitability using noninvasive transcranial direct current stimulation (tDCS) lessens the~     severity of the symptom triad associated with cerebral microvascular disease (CMD); that is,~     slow gait, cognitive dysfunction and depressive symptoms. Investigators will complete this~     objective by conducting a pilot, double-blinded randomized controlled trial of a 10-day~     intervention of real versus sham tDCS in 40 subjects.~   "
86342|NCT02436902|"~     Hepatocellular carcinoma (HCC) is a common malignancy, and its incidence is expected to~     increase in many countries in coming decades. Though prognosis for patients with HCC is~     generally poor, hepatic resection can be an effective curative treatment, and its indications~     have been expanding in recent years. Resection can be reasonably safe and effective even for~     patients with micro- or macrovascular invasion. However, the recurrence rate of HCC is as~     high as 74% for patients with intermediate and advanced HCC after resection. Microvascular~     invasion is one of the main risk factors which influence risk of HCC recurrence and patient~     prognosis after resection. Therefore, adjuvant therapy to prevent tumor recurrence after~     resection is so important to improve patient prognosis.~      Nowadays, adjuvant transarterial chemoembolization (TACE) is reported to be effective in~     reducing early recurrence rate and mortality for patients with HCC with risk factors of~     recurrence. Sorafenib is a novel drug which is effective for advanced stage HCC. However, the~     efficacy of adjuvant sorafenib for postoperative HCC is unknown. Therefore, it is interesting~     to investigate the efficacy of adjuvant sorafenib, and compare its efficacy to TACE, TACE~     plus sorafenib, or best supportive care for patients with postoperative HCC and microvascular~     invasion.~   "
86343|NCT02436889|"~     An 8-week randomized, controlled, pilot clinical trial of Mirabegron compared to a standard~     anticholinergic therapy (Detrol LA) in elderly women with urgency urinary incontinence.~   "
86344|NCT02436876|"~     This study evaluates the safety and clinical benefit of MBN-101 administered intraoperatively~     to osteosynthesis or osteomyelitis sites for patients diagnosed with an orthopedic infection,~     with or without orthopaedic hardware. Three quarters of the patients will receive MBN-101,~     while the other one quarter will receive placebo.~   "
86345|NCT02436863|"~     The lesion located inside the spinal canal caused big trouble for clinical treatment.~     Traditional laminectomy will destroy the biomechanics and influent the vertebral stability,~     which might cause kyphosis or other deformity. So in some centers, neurosurgeries praised~     laminoplasty to make the intactness of posterior column. They thought the laminoplasty can~     maintain the vertebral stability, and meanwhile the range of motion won't change so much.~     However, some other scholars thought laminoplasty had no helps for stability because of the~     pseudarthrosis. They preferred screw and stick system for internal fixation. And we did meet~     several patients after laminectomy suffered with spinal deformity. So we thought it is~     necessary for investigating the benefit of patients from laminoplasty and internal fixation.~   "
86346|NCT02436850|"~     The purpose of the trial is to evaluate the effectiveness of moderate to large volume~     thoracentesis (TC) in non-ventilated patients in Internal Medicine admitted due to, or suffer~     from respiratory instability. This is a prospective, double-center, randomized clinical~     trial. This is a stage 1 pilot trial aimed to provide better understanding on the study~     population and study groups. This trial will comprise a total of 60 patients, 30 subjects on~     the intervention group and an equal number on the control group. The results of this pilot~     trial will be to design a larger trial and calculate a required sample size.~   "
86369|NCT02436551|"~     Evaluate prevalence and management of gestational diabetes in Tajikistan in two different~     settings (one rural and one urban).~   "
86370|NCT02436538|"~     Anti-Müllerian hormone (AMH), also known as Müllerian inhibiting substance, is a dimeric~     glycoprotein that belongs to the transforming growth factor-beta family. It is involved in~     the regression of the Müllerian ducts during male fetal development. In the female, AMH is~     solely produced by the granulosa cells of preantral and small antral follicles, and regulates~     ovarian activity and follicular steroidogenesis~   "
86349|NCT02436811|"~     This is study aims to evaluate the retention of information on oral health and eating habits~     in children under two years of age. A total of 180 pregnant women aged between twelve and~     fifty years of age will be selected for this study. Before the randomization process, the~     literacy in oral health score will be assessed through previously validated instrument~     BREALD- 30. Participants will be randomly selected according to the value of BREALD-30,~     categorized as adequate (≥18) and low (<18) in a specific intervention. Interventions occur~     in written form through an educational brochure or standardized oral, both with information~     about the feeding practices and oral health in children under two years. The control group~     will be the implementation of an educational booklet on oral cancer. To evaluate the~     association between variables pregnant women will respond to a semi-structured form with~     questions regarding oral health and nutrition, in three different times: before the~     intervention, 15 minutes after the intervention and 4 weeks after the intervention. Social~     and economic and demographic data will be evaluated at baseline. The data will be~     statistically analyzed by Student's t-tests and ANOVA paired, adopting a 5% significance~     level. In the event of non-normality of the data, the corresponding non-parametric~     statistical tests will be applied. This study has the hypothesis that the written~     intervention presents best results in participants with high literacy and the standardized~     oral with those with low literacy.~   "
86350|NCT02436798|"~     5-HT3 antagonists (ondansetron) are highly effective medications for the treatment of nausea~     and vomiting. However, these medications also associated with potentially severe and~     life-threatening cardiac adverse drug reactions (ADRs), particularly QT prolongation. Data~     regarding the cardiac safety and inter-individual variability in cardiac effects of~     ondansetron when used in vulnerable populations such as children and pregnant women are very~     limited. The results of this study will enable better-informed therapeutic decision-making~     regarding the use of ondansetron in children and pregnant women, with the overall goal to~     improve the safety of these commonly used antiemetic medications. Furthermore, predictive~     pharmacogenetic markers of severe 5-HT3 antagonist toxicity could be used to identify~     patients at risk of cardiac toxicity before the drug is administered.~   "
86351|NCT02436785|"~     Pain management is rated by patients with inflammatory arthritis as the highest priority in~     their disease treatment. Past research showed that music therapy is associated with reduced~     pain and depression. The purpose of this study is to better understand the effectiveness of~     music therapy for people with inflammatory arthritis. Participants will be randomly assigned~     to: 1) Music Therapy group facilitated by a music therapist, or 2) Music Listening group that~     listens to a relaxation CD (compact disc). Standardized tests will determine if participating~     in music therapy group helps reduce pain and depression, improve physical function and~     confidence levels in applying self-management strategies.~   "
86352|NCT02436772|"~     This study evaluates the performance of a blood test for detecting biomarkers in metastatic~     breast cancer patients at one clinic against standard testing.~   "
86353|NCT02436759|"~     This is a Phase 3 study is to evaluate the safety and efficacy of RVL-1201 Ophthalmic~     Solution in the treatment of acquired blepharoptosis (ptosis) and to assess the safety and~     comfort of RVL-1201 Ophthalmic Solution for an extended dosing period of 6 weeks.~   "
86354|NCT02436746|"~     Both Neurofibromatosis type 1 (NF1) and Tuberous Sclerosis Complex (TSC) are highly~     heterogeneous diseases. Cognitive features seem to vary widely even between family members~     carrying the same mutation. This phenotypic variability is not well understood, but is~     generally assumed to be caused by modifier genes which regulate the affected pathways.~     However, recent studies brought forward an alternative explanation for the phenotypic~     variability. Post-mortem studies showed that second hit mutations causing loss of the second~     ('healthy') allele are more widespread than previously believed. These loss of heterozygosity~     (LOH) mutations cause bi-allelic loss of the disease-linked gene and are known to cause the~     gross of somatic features in both diseases (like neurofibromas and hamartomas). Hence, it~     could be the stochastic occurrence of second-hit mutations in the brain are the cause of the~     variable cognitive phenotypes.~      To investigate to what extent these LOH mutations in the brain contribute to the phenotype~     and to what extent this variation is due to genetic modifiers factors is unknown. The~     investigators therefore propose to elucidate this variability by comparing the correlation of~     cognitive features of monozygotic twins with NF1 or TSC to healthy twins in the population.~     If modifier genes are the cause of the variability of cognitive features in NF1 and TSC the~     investigators expect that the variability in cognitive tests in monozygotic twins is the same~     as monozygotic twins in the healthy population. However, if the variability is caused by the~     occurrence of LOH mutations, the investigators expect to have a lower correlation in our~     monozygotic patients compared to the healthy twins.~   "
86355|NCT02436733|"~     This is a multicenter, randomized, 1:1, non-comparative phase II trial. Patients with early~     stage MPM will be randomized between Arm A: immediate P/D followed by three cycles of~     chemotherapy (pemetrexed 500mg/m2 and cisplatin 75 mg/m2, both drugs given on day 1, every~     three weeks) Arm B: three cycles of chemotherapy (same regimen) followed by P/D, for~     non-progressing patients~   "
86371|NCT02436525|"~     Microbial and periodontal changes associated with conventional versus self ligating brackets.~      The aim of this study will be to compare microbial and periodontal changes associated with~     conventional versus self ligating brackets.~   "
86372|NCT02436512|"~     The EAGLE study is a Phase 3, open-label, multi-center, two-part, single-arm study of~     GeNOsyl(R) delivery system(s) to evaluate if inhaled nitric oxide-induced vasodilation~     predicts successful wean from parenteral prostacyclin (PGI) in subjects with World Health~     Organization (WHO) Group 1 pulmonary arterial hypertension (PAH) undergoing a medically~     necessary right heart catheterization (RHC). All subjects enrolled in the study will undergo~     an attempt to wean from parenteral PGI per standard of care.~   "
86373|NCT02436499|"~     Pilot study evaluating effect of Botox injection treatment for 12 individuals suffering from~     chronic migraine on function MRI imaging, before and after treatment.~   "
86374|NCT02436486|"~     To evaluate the effect of idalopirdine (120 and 360 mg) on cardiac repolarisation in healthy~     men.~   "
86547|NCT02434224|"~     This study investigates whether creative music therapy applied to premature infants will~     facilitate brain growth and development at term equivalent assessed by magnetic resonance~     imaging. Secondary objective are improvement of neurobehavioral outcomes of premature infants~     at 24 months, as well as at 5 years of age.~   "
86356|NCT02436720|"~     The literature on outcome measures assessing upper limbs in Duchenne muscular dystrophy (DMD)~     is quite scanty. While there have been considerable advances for ambulant DMD boys, no~     prospective study has so far been devoted to outcome measures in non ambulant patients, with~     increasing complaints from families and patients. This information appears to be highly~     important not only for a better understanding of the progression of the disease but also for~     possible enrollment of patients in future trials.~      The aim of this project is to identify outcome measures for non ambulant patients in an~     Italian population of DMD patients. At least 200 non ambulant DMD boys and adults will be~     included in the study. All patients will be assessed using the newly developed Performance of~     Upper limb (PUL) test. This measure will be used at baseline and 6 and 12 months after~     baseline. This will allow to monitor possible changes over time and the rate of changes in~     patients with different level of ability and age. As part of this study the investigators~     will also correlate possible changes in upper limb function with other measures of care and~     function such as the EK scale.~      The investigators aim to assess the suitability of the individual measures in a large number~     of patients, trying to establish whether whole scales or individual items appear to be~     relevant across ages and level of abilities. The investigators also aim to assess the~     suitability of the selected measures in a multicentric setting and the quantity of training~     required The data collected will also be analysed using Rasch analysis in order to improve~     the statistical properties of the measures used.~   "
86357|NCT02436707|"~     The purpose of this study is to find out what effects new combinations of treatment will have~     this disease. In this clinical trial, the study treatment options currently are ibrutinib~     plus R-GDP, or R-GDP alone.~   "
86358|NCT02436694|"~     Can the association of dexamethasone to the local anaesthetic in a single-shot femoral and~     sciatic nerve block improve analgesia postoperatively in patients submitted to total knee~     arthroplasty? Primary aim: Evaluate the efficacy of the association of dexamethasone to the~     local anaesthetic in a SSFNB and SSSNB in reducing pain scores, assessed by VAS.~      Outcome measures: Mean pain scores in both groups. Secondary aims: Evaluate opioid~     consumption in the postoperative period (8- 12h, 24h, 48h) and assess incidence of side~     effects and complications (numbness, paraesthesias, weakness, site infection, haematoma and~     falls).~   "
86359|NCT02436681|"~     Miromatrix Medical has developed MIROMESH® - a new, noncrosslinked, acellular mesh derived~     from the highly vascularized porcine liver. MIROMESH received FDA 510(k) clearance with an~     indication for reinforcement of soft tissue on March 31, 2014 under K134033. This study will~     serve to provide clinicians with high-quality clinical data in order to provide them with a~     higher degree of confidence when selecting MIROMESH for hiatal hernia repair.~   "
86360|NCT02436668|"~     This is a phase 2/3 to evaluate the efficacy of ibrutinib in combination with nab-paclitaxel~     and gemcitabine for the first line treatment of patients with metastatic pancreatic~     adenocarcinoma.~   "
86361|NCT02436655|"~     Whether to intervene in asymptomatic patients with severe aortic stenosis and normal left~     ventricular ejection fraction remains controversial. The investigators therefore try to~     compare clinical outcomes of elective aortic valve replacement to conventional treatment and~     watchful waiting strategy in a prospective randomized trial.~   "
86362|NCT02436642|"~     The devices used in this observational registry are the Osprey Medical Contrast Monitoring~     System (CMS) and the Osprey Medical AVERT Reflux Reduction System. Both products have CE Mark~     designations. The purpose of this registry is to evaluate the usability characteristics of~     the combined Osprey Medical AVERT System and the Contrast Monitoring System during normal~     clinical use.~   "
86363|NCT02436629|"~     The objective of the current study is to assess the effect of 6-day dietary nitrate ingestion~     on high intensity intermittent sports performance in recreational soccer players.~   "
86364|NCT02436616|"~     The study utilizes microEEG (a novel miniaturized, FDA approved EEG device) to prospectively~     investigate the cerebral electrical activity of infants with Apnea, Bradycardia and~     Desaturation events. This project will also assess the feasibility of using the microEEG~     device in the Neonatal Intensive Care Unit (NICU) setting and the feasibility of remote~     centralized interpretation in this setting.~   "
86365|NCT02436603|"~     The purpose of this project is to examine whether a low cost, group-oriented integrative~     medicine approach to irritable bowel syndrome improves participant outcomes. The intervention~     will combine nutrition counseling on the low FODMAP diet (decreased grains and other~     disaccharides) and mind-body training with follow-up health coaching.~      These participants will be randomized to either a 4-week group-oriented treatment~     intervention incorporating a low FODMAP (fermentable oligosaccharides, disaccharides,~     monosaccharides and polyols) diet and mind-body therapies followed by an 8-week health~     coaching follow-up period or a waitlist control group. At the end of the 12-week study~     period, waitlist subjects will be offered the four-week nutrition and mind-body intervention.~     Over the 12-week study period, we will examine and report on the impact of this treatment~     intervention on IBS symptoms and quality of life in this population. The investigators will~     collect data on IBS outcomes as well as on depression and stress.~   "
86366|NCT02436590|"~     The hypothesis of this study is that exposure to PEMF alters the cytokine environment of OA~     joints associated with a reduction of inflammation and improved homeostasis of the~     extracellular matrix (ECM), both potentially effecting symptomatic relief of OA pain,~     reducing cartilage breakdown, stimulate new cartilage formation therefore preserving joint~     structure.~   "
86367|NCT02436577|"~     This study will be an open-label, randomised, three-period, three-treatment, crossover study~     in healthy Japanese male and female of non-childbearing potential subjects, performed at a~     single study centre.~      The objective of the study is to assess the bioequivalence of ticagrelor orodispersible (OD)~     tablets when administered with water and without water and ticagrelor immediate-release (IR)~     tablets.~   "
86368|NCT02436564|"~     The primary objective is to develop an in vitro model of cancer for laboratory study using~     liver, biliary and pancreatic cancer tissue. The secondary objective is to study the genetic~     and cellular biology of cancer of the liver, biliary tract and the pancreas. As well the~     investigators hope to compare molecular and cellular biology of cancer cells with normal~     cells as well as potentially test the efficacy of current and future anti-cancer therapies.~      Samples will be collected from tissue that has been resected as part of the treatment for a~     patient diagnosed with liver, bile duct or pancreas cancer.~   "
86377|NCT02436447|"~     This study is a Phase 1, open-label, parallel group, multiple dose study, in subjects over 18~     years, to evaluate the safety, tolerability, and pharmacokinetics of one-hour intravenous~     infusion of MTP-131 administered for 7 consecutive days. Twenty-four subjects are planned to~     be enrolled into 4 cohorts of varying renal function, with each cohort consisting of 6~     subjects.~   "
86378|NCT02436434|"~     Pulsed radiofrequency (PRF) is designed to alleviate pain by delivering an electrical field~     and heat bursts at a temperature less than 42°C to neural tissue. In contrast with~     conventional radiofrequency, PRF is controlled below 42°C without damage to nerves and many~     studies have shown its benefits in pain relief for certain kinds of chronic pain conditions.~     For lessening pain of certain joint arthropathy, the direct nerve block by application of PRF~     is difficult and complicated because the supplying nerve of joint is complex or small. Hence,~     some authors perform intra-articular PRF on the chronic painful joint for example, knee~     osteoarthritis, atlantoaxial joint, cervical facet joint sacroiliac joint, scapholunate and~     shoulder joint and the excellent long-term effects are reported.~      The purpose of this study is to investigate the effect of intra-articular PRF in~     osteoarthritis.~   "
86379|NCT02436421|"~     This quality improvement intervention seeks to implement two Best Practice Alerts (BPAs) for~     use in cardiology clinics while simultaneously evaluating the impact of each BPA- one for~     patients with uncontrolled blood pressure and one for patients with atrial fibrillation not~     on anticoagulation.~   "
86380|NCT02436408|"~     Basal cell carcinoma (BCCA) is the most common human cancer, and frequently affects facial~     structures. While rarely fatal, facial BCCA can be disfiguring and expensive to treat.~      Vismodegib is a small molecule inhibitor of SMO developed for the treatment of tumors in~     which the Hh signaling pathway appears to contribute to the development and maintenance of~     tumorigenesis. Vismodegib was recently approved by the Food and Drug Administration (FDA) for~     treatment of metastatic and locally advanced BCCA. Recent reports have suggested that~     vismodegib treatment for orbital BCCA may facilitate eye preservation even if surgery is~     eventually required~      In order to assess the potential of vismodegib to improve the ophthalmic outcomes following~     treatment for orbital and/or periocular BCCA, this study will follow patients with~     globe-threatening orbital and lacrimal-threatening periocular BCCA who are being treated with~     vismodegib as standard of care.~   "
86381|NCT02436395|"~     Surgical site infections (SSIs) is one of the most common complications of upper abdominal~     surgery. Previous studies found that type of surgical incision, emergency operation or not,~     surgical duration, age of patient, body mass index, malignance duration, malnutrition,~     complications (diabetes, shock, anemia et al) and drug (Long-term use of corticosteroids) are~     closely associated with the incidence of SSIs. The general incidence rate of SSIs was about~     5% to 40%, although using the preoperative skin disinfectant and other methods to prevent and~     reduce the SSIs. And for the gastrointestinal surgery, due to the potential risk of~     infection, SSIs is an important problem which cannot be ignored. On the other hand, gastric~     cancer is one of the most common digestive system tumors, and gastrectomy is the primary~     therapeutic options. Therefore, it is important to compare the whether the different liquid~     (1% povidone-iodine solution or the 0.9% normal saline) wash the incision can influent the~     incidence of the SSIs.~   "
86382|NCT02436382|"~     Neonatal hypothermia is associated with increased risk of mortality as well as multiple~     morbidities. The investigators objective is to determine if an increase in ambient operative~     room temperature decreases the rate of hypothermia. Operating room temperature will be~     randomized to the current institutional standard (67°F) or a temperature of 73°F on a weekly~     basis for a period of six months.~   "
86383|NCT02436369|"~     The investigators aimed to add flaxseed with high content of n-3 polyunsaturated fatty acids~     to low fat yogurt to obtain beneficial without adverse effects of it. In this parallel~     randomized controlled trial the investigators recruited 70 diabetic patients and randomly~     allocated to control and treatment groups. Participants in treatment group consumed 30 gr~     flaxseed in 200 gr low fat yogurt, while controls consumed 200 gr just low fat yogurt daily.~     Lipid profile, fasting blood sugar, glycosylated hemoglobin, systolic and diastolic blood~     pressure, weight, waist circumference and body mass index were measured at the first and end~     of the trial.~   "
86384|NCT02436356|"~     The goal of this study is to determine whether two new, non-X-ray techniques can discriminate~     between high-energy fractures of normal bone (trauma) and low-energy fractures (fragility) of~     osteoporotic bone. The current gold-standard for assessing fracture risk areal bone mineral~     density (aBMD) by dual energy X-ray absorptiometry (DXA) is not particularly effective at~     identifying individuals who are at risk of suffering a fracture. Yet, there is a growing~     population of diabetics and elderly individuals prone to fractures. In effect, the~     age-related and diabetes-related increase in fracture risk is independent of a person's aBMD.~     These findings stress the urgency in developing diagnostic tools that can improve fracture~     risk prediction so that patients can be treated with the appropriate anti-fracture therapies.~   "
86385|NCT02436343|"~     The aim of this work is to Assess serial changes in cardiovascular function in morbidly~     obese pregnant females (BMI equal or higher than 30 kg/m2) as compared to normal lean~     pregnant female controls.~   "
86386|NCT02436330|"~     Evaluation of the effectiveness of Exergaming for Health, a community-based multifaceted~     weight management program in a randomized controlled trial (RCT). Primary objective: to~     assess impact of the program on BMI z-scores. Secondary objectives: to measure impact on~     cardiovascular fitness, self-worth, sedentary screen time, and the influence of exergaming~     component on attendance and participation.~   "
86387|NCT02436317|"~     This is a Prospective, Double-center, randomized clinical trial. The purpose of the trial is~     to evaluate the benefit of adding POC US to the management of inpatients admitted to the~     internal ward with respiratory, cardiovascular or hemodynamic abnormalities.~   "
86388|NCT02436304|"~     The purpose of this study is to evaluate EXE844 plus tympanostomy tubes compared to~     tympanostomy tubes only based on sustained clinical cure at end-of-therapy (EOT).~   "
86389|NCT02436291|"~     Open label study to evaluate the efficacy of CURE-EX device in the treatment of~     onychomycosis.~   "
86390|NCT02436278|"~     This study investigates whether usual walking speed, measured by the 4 metre gait speed test~     (4MGS), and change in usual walking speed over 6 months predicts death and hospital~     admissions in patients with Idiopathic Pulmonary Fibrosis.~   "
86391|NCT02436265|"~     Caudal injection of local anesthetic is a neuraxial technique routinely performed on young~     children for postoperative analgesia after lower abdominal and lower extremity surgical~     procedures. One of the major limitations of the use of single shot neuraxial injections for~     this purpose is the limited duration of action of the injected local anesthetic. Adjuvant~     medications, such as clonidine and epinephrine, have been added to the local anesthetic to~     prolong the duration of the neuraxial block, with varying results. Dexamethasone is a~     synthetic glucocorticoid steroid commonly used in the perioperative setting for a multitude~     of indications, including the prolongation of local anesthetic based analgesia. It has been~     shown that the administration of dexamethasone either intravenously or via perineural~     injection can significantly increase the duration of analgesia derived from a local~     anesthesia based peripheral nerve block. Literature also suggests that the effect of~     dexamethasone is equivalent whether given intravenously or perineurally. Interest in~     dexamethasone enhanced caudal analgesia exists and a previous study noted that caudal~     anesthesia can be prolonged by intravenous dexamethasone. The study was criticized for using~     a higher dose of dexamethasone (0.5 mg/kg) than is routinely used in the pediatric population~     outside of airway procedures, which may expose patients to dose related side effects of~     dexamethasone. A large meta-analysis has suggested that 0.1 mg/kg is effective for analgesic~     prolongation, but no direct study of low dose intravenous dexamethasone in combination with~     caudal anesthesia has been performed.~   "
86392|NCT02436252|"~     This is a phase 1/2, uncontrolled, open-label, multicenter study in patients with MDS for~     whom no effective therapies currently exist.~   "
86393|NCT02436239|"~     The purpose of this study is to evaluate the long-term safety and tolerability of vilazodone~     for the treatment of MDD in pediatric outpatients (7-17 years).~   "
86394|NCT02436226|"~     The purpose of this study is to evaluate the effect of administration of low dose of human~     chorionic gonadotropin (HCG) after use of clomiphene citrate (CC) for induction of ovulation~     in infertile women having CC resistant polycystic ovarian syndrome (PCOS).~   "
86395|NCT02436213|"~     Pulmonary arteriovenous malformations (PAVMs) are a rare vascular condition affecting the~     lungs. PAVMs lead to low blood oxygen levels, yet are very well tolerated by patients. This~     study will examine the exercise capacity of PAVM patients using formal cardiopulmonary~     exercise tests performed on a stationary bicycle.~   "
86396|NCT02436200|"~     This study will assess the benefit of a neuromuscular electrical stimulation device in~     patients suffering from symptoms and effects of lower limb intermittent claudication.~   "
86397|NCT02436187|"~     The aim of the study is to quantify the excess mortality associated with non-adherence to~     care for non ST-elevation myocardial infarction in England and Wales over the last decade.~   "
86398|NCT02436174|"~     Shivering is a common side-effect of epidural anesthesia. In studies to date, the assessment~     of shivering has been based on a simple scale using descriptive words rather than actual~     measurements. We believe that we can assess shivering more scientifically by using a novel~     method to quantify arm movements during shivering.~   "
86399|NCT02436161|"~     OBJECTIVE: To evaluate the effectiveness of a multidisciplinary care management collaborative~     program for high-risk patients with heart failure (HF) who are admitted at hospital, based on~     the 6 components of the Chronic Care Model PROMIC, in terms of reduction of a Combined~     event rate (readmissions / cardiac events / death / emergency department visits) and other~     variables, the feasibility of the program, the improvement on quality of life related to~     health and functional capacity of the PROMIC patients compared with control patients in usual~     care.~      DESIGN: A quasi-experimental, prospective one year follow-up study. SETTING AND SUBJECTS:~     Primary Health care Centres of Interior County in Bizkaia and of Araba County in Araba,~     Galdakao Hospital, Santa Marina Hospital and University hospital os Araba in the Basque~     Country. Will be captured as a minimum intervention group of 125 patients admitted for HF in~     New York Heart Association (NYHA) functional status II-III-IV from previous mentioned~     hospitals. Another 125 patients from different primary health care centers, will be the~     control group.~      INTERVENTION: The intervention to be applied will be PROMIC, control patients will receive~     usual care MEASUREMENTS: The mean outcome measure will be the time free of events from the~     time of inclusion to the first event (readmission / cardiac events / death / emergency~     visits). Secondary endpoints will be the quality of life related to health (MLFHQ and SF-12),~     functional capacity (6-Minute Walk Test), structural changes in cardiac structure~     (natriuretic peptide levels), adherence to drug treatment (Morinsky-Green), the cost of the~     program, the usefulness and acceptability of PROMIC by professionals and patients. Predictor~     variables also will be collected such as sex, age, education level, co-morbidity, social risk~     level, dependency etc.~      STATISTICAL ANALYSIS: Analysis was performed by intention to treat. Survival curves will~     done. A model of Cox proportional hazards will be built.~   "
86400|NCT02436148|"~     The present study assesses the reliability and validity of the Finnish version of Prothesis~     Evaluation Questionnaire. Major lower extremity amputees who use prosthesis are requited for~     the present study from the Helsinki and Uusimaa Hospital District and the Central Finland~     Health Care District.~   "
86401|NCT02436135|"~     This study will evaluate the safety, tolerability, pharmacokinetics, and efficacy of~     idelalisib in adults receiving ruxolitinib as therapy for intermediate to high risk primary~     myelofibrosis (PMF), post-polycythemia vera, or post-essential thrombocythemia myelofibrosis~     (post-PV MF or post-ET MF) with progressive or relapsed disease.~   "
86402|NCT02436122|"~     The effect of preoperative glycemic control measured by HbA1c on prostate cancer (PCa)~     outcome remains controversial. Thus, the investigators aim to examine the association of~     preoperative glycemic control with oncologic outcomes after radical prostatectomy (RP).~      The investigators will prospectively collect the relevant data including preoperative HbA1c~     in 264 patients of PCa patients undergoing RP. The associations between clinical variables~     and risk of adverse pathological features and disease recurrence will be tested using a~     multivariate logistic regression and multiple Cox-proportional hazards model, respectively.~   "
86403|NCT02436109|"~     Most women delivering by cesarean at BC Women's receive regional anesthesia; which includes~     spinal, epidural, or combined spinal-epidural anesthesia. In all these techniques a needle is~     placed in the lower back and local anesthetic is injected to freeze the body. Normally,~     before the needle is placed in a patients' back, the anesthesiologist will feel between their~     back bones with his/her fingers to find the right spot for the needle. This study will be~     evaluating if the distance from the skin to the appropriate spinal space measured with a~     novel 3D Ultrasound will equal the actual depth of the needle insertion.~   "
86548|NCT02434211|"~     The main objective this project is the development of a measurement tool. This consists of~     construct and validate a questionnaire to conduct a quantitative assessment of knowledge and~     individual conceptions of cancer enrolled in CM1 and CM2 (9-11 years).~   "
86404|NCT02436096|"~     The use of low-dose CBP dosed nightly at bedtime for FM was supported by the results of~     Tonix' TNX-CY-F202 Phase 2b study (also referred to as the BESTFIT Study). The TNX-CY-F202~     study provided strong evidence that TNX-102 SL 2.8 mg dosed nightly results in beneficial~     effects upon pain, sleep and other FM symptomatology.~      The present trial is designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets,~     taken daily at bedtime over 12 weeks to treat fibromyalgia.~   "
86405|NCT02436083|"~     The purpose of this study is to monitor and compare peri-operative problems and outcomes of~     reconstructive surgery with microvascular free flaps in the head and neck region between~     groups of patients treated with perioperative antibiotics and a group of patients without~     antibiotics.~   "
86406|NCT02436070|"~     BACKGROUND Asthma is a prevalent and troublesome pediatric condition. In 2013, Emergency~     Department (ED) providers treated over 3,500 cases of asthma-related complaints at Children's~     Hospitals and Clinics of Minnesota. Pediatric ED visits for asthma exceeds billions of~     dollars annually when including direct cost and lost productivity. Many of these visits and~     resultant costs are avoidable. Patients with well-controlled asthma do not typically exhibit~     these patterns, while patients with poorly controlled asthma show patterns of increased~     utilization of healthcare resources and lower quality of life. Evidence suggests that a text~     message reminder and educational program might positively influence pediatric asthma care~     practices.~      RESEARCH QUESTION Does a targeted ED based text message intervention program improve~     outpatient follow-up and routine preventive care in pediatric asthma patients?~      METHODS Study subjects will be block randomized based on age and insurance group. The~     experimental group will receive text messages with guidance towards follow-up care with their~     PCP and the importance of the flu vaccine for children with asthma. The control group will~     receive a series of educational self-care and health based text messages unrelated to asthma~     or the flu vaccine. Some self-report of behaviors will be captured via text message response.~      ANALYSIS Primary outcomes for the educational versus targeted text message groups will be~     compared use Chi-square tests. Additional adjustments may be applied for missing data or if,~     despite randomization, there is substantial imbalance between group in key covariates (eg~     race/ethnicity, insurance type or asthma severity.)~   "
86407|NCT02436057|"~     Through a four-year grant awarded to the University of California at Los Angeles in 2009, Dr.~     Brennan Spiegel served as a principal investigator (PI) for a project to develop and~     initially validate a bank of items to assess gastrointestinal (GI) symptoms for the National~     Institutes of Health's (NIH's) Patient Reported Outcomes Measurement Information System~     (PROMIS). By the end of the grant period in July 2013, the project team had successfully~     developed and initially validated eight scales measuring the most common GI symptoms.~      Afterwards, Dr. Spiegel's PROMIS team joined forces with the UCLA Computing Technology~     Research Laboratory (CTRL) and the University of Michigan Center for Healthcare Communication~     Research to develop the Automated Evaluation of Gastrointestinal Symptoms (AEGIS) algorithm~     which is delivered via My GI Health, an open-‐source Internet based patient-provider portal~     (P3) designed to enhance the delivery of GI health care (www.MyGIHealth.org). Through My GI~     Health and AEGIS, patients are able to complete PROMIS GI symptom measures and provide~     additional information about their GI symptoms and histories from computers, tablets or smart~     phones without the constraints of physical locale. This information is condensed into a GI~     PROMIS scores report and initial GI history that patients' providers can review prior to or~     concurrent with seeing the patient. The report, which can be incorporated into the electronic~     health record (EHR), helps busy clinicians to quickly understand the patient's complaints,~     document their symptoms and GI history, and leaves more time for conversation with the~     patient.~      Beyond focusing their interaction, My GI Health also supports both the clinician and patient~     with an individualized educational prescription which guides the patient through a library~     of multi‐media educational materials on GI symptoms, conditions, and treatments also~     contained within the website. The prescription is initially created by the website based on~     each patient's unique GI PROMIS fingerprint, and can be modified by the provider based on~     their interaction with the patient. The clinician and patient can also access the~     PROMIS-tailored education in the exam room to jointly review pertinent materials, including~     animations of normal and abnormal GI functions, further reinforcing the patients' educational~     experiences around the PROMIS symptoms.~      The aim of this current study is to validate the use of GI PROMIS in clinical practice by~     conducting a pragmatic clinical trial (PCT) comparing delivery of GI PROMIS on a novel~     e--platform vs. usual care.~   "
86408|NCT02436044|"~     A large proportion of Asian patients with HCC present with locally advanced or metastatic~     disease,at which point they are ineligible for curative treatments.Oxaliplatin plus~     fluorouracil/leucovorin intravenous infusion was proved effective in prolonging~     progression-free survival(PFS) than doxorubicin as palliative chemotherapy in patients with~     advanced HCC from Asia. Besides, hepatic arterial infusion chemotherapy (HAIC）is a widely~     used method for primary or metastasis liver tumor with high local tumor response. To our~     knowledge, there have not been any prospective studies to assess the safety and effecacy of~     HAIC using oxaliplatin plus fluorouracil/leucovorin for patients with locally advanced~     HCC.Thus,the purpose of this phase 2 study was to assess the safety and effecacy of HAIC~     using oxaliplatin plus fluorouracil/leucovorin for patients with locally advanced HCC.~   "
86409|NCT02436031|"~     Obstructive sleep apnea (OSA) is common and has major health implications but treatment~     options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle~     activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared~     to normal participants. Until recently, the search for medicines to activate pharyngeal~     muscles in sleeping humans has been discouraging. However, exciting new animal research has~     shown that drugs with noradrenergic and antimuscarinic effects can restore pharyngeal muscle~     activity to waking levels. In this protocol the investigators will test the effect of~     desipramine (a tricyclic antidepressant with strong noradrenergic and antimuscarinic effects)~     on upper airway collapsibility and genioglossus muscle activity (EMG GG) during sleep in OSA~     patients.~   "
86410|NCT02436018|"~     Low pulse oximetry is the most common adverse events during sedation for upper~     gastrointestinal endoscopy. The main reason is the glossoptosis after sedation. In present~     study a new designed nasopharyngeal airway embedded with jet ventilation catheter(WEI NASAL~     JET) will be utilized in order to reduce the hypoxia. At the same time the safety will be~     evaluated.~   "
86411|NCT02435992|"~     The purpose of this study is to determine whether RPC1063 is effective in the treatment of~     Ulcerative Colitis (UC).~   "
86412|NCT02435979|"~     This study will be a randomized controlled trial comparing proximal strengthening vs.~     traditional hand therapy for patients with wrist pain. Patients will attend 2 hand therapy~     sessions per week for 4 weeks. Change in patient function and pain as measured by the patient~     rated wrist evaluation will be the primary outcome of interest~   "
86549|NCT02434198|"~     The primary aim of this study is to investigate the incidence of falling in a cohort of~     patients with chronic obstructive pulmonary disease (COPD) referred to a pulmonary~     rehabilitation program and to verify the risk factors. The secondary aim is to verify whether~     available balance assessment tools are feasible in clinical practice and which tools and~     values can best predict falls in people with COPD.~   "
86413|NCT02435966|"~     The investigators study the efficacy of a combination of dry needling plus manual therapy~     against sham dry needling plus manual therapy in the treatment of chronic neck pain. The~     investigators identify the most active trigger point in the upper trapezius and levator~     scapulae and administer two treatments, with an interval of 7 days, with a follow up 30 days~     after the first intervention. The primary outcome is the Visual Analogue Scale of Pain.~     Secondary outcomes ar pressure pain threshold, Neck Disability Index (NDI) questionnaire and~     range of motion.~   "
86414|NCT02435953|"~     The current standard treatment for intermediate-stage HCC (BCLC stage B) is transcatheter~     arterial chemoembolization (TACE) alone.The combination of TACE with RFA has also reported to~     be an effective treatment for HCC. Some prospective studies have shown TACE combined RFA to~     have better efficacy than any of them alone for early stage HCC (single tuomor ≤5 cm).~     However, to the investigators' knowledge, there have not been any prospective studies to~     assess whether TACE combined sequentially with RFA is more effective than TACE alone for the~     treatment of intermediate-stage HCC. The investigators hypothesized that the combination of~     TACE and RFA might result in better patient survival than TACE alone. Thus, the purpose of~     this study was to prospectively compare the effects of sequential TACE-RFA with TACE alone~     for the treatment of intermediate-stage HCC. Intermediate-stage HCC in this study was defined~     as 2-3 intrahepatic lessions, largest tumor size 3-7 cm or 4-10 intrahepatic lessions,~     largest tumor size ≤7 cm; ECOG-PS 0;Child-pugh A or B;no tumor thrombus or extrahepatic~     metastases.~   "
86415|NCT02435940|"~     My Retina Tracker® is a registry for people affected by an inherited retinal degenerative~     disease. It is a patient-initiated registry accessible via a secure on-line portal at~     www.MyRetinaTracker.org. Affected individuals and genetically related, unaffected, family~     members who create entries are guided to create a profile that captures the participants'~     perspective on their disease and its progress; family history; genetic testing results;~     preventive measures; and interest in participation in research studies. The participants may~     also choose to ask their clinician to add clinical measurements and results at each clinical~     visit. Participants are urged to update the information regularly to create longitudinal~     records of their disease, from their own perspective, and their clinical progress. The~     overall goals are: to better understand the heterogeneity of the inherited retinal~     degenerative diseases; to understand the prevalence of the different diseases and gene~     mutations; to assist in the establishment of genotype-phenotype relationships; to help~     understand the natural history of the diseases; to help accelerate research and development~     of clinical trials for treatments; and to provide a mechanism that facilitates more rapid~     recruitment for research studies and clinical trials.~   "
86416|NCT02435927|"~     This is a Phase I, open-label, dose escalation study of ASLAN001 given in combination with~     CAPOX or mFolfox6, in patients with metastatic solid tumours, whom are suitable to receive~     CAPOX or mFolfox6, or with tumours that have dysregulated EGFR or HER2 signaling.~   "
86417|NCT02435914|"~     This study will evaluate the safety, efficacy, tolerability, and systemic pharmacokinetics of~     3 different doses of topical ophthalmic AGN-223575 suspension compared to AGN-223575 vehicle~     in patients with dry eye disease.~   "
86418|NCT02435901|"~     This study will evaluate the use of reduced intensity conditioning regimen in patients with~     high risk hemoglobinopathy Sickle Cell and B-Thalassemia Major in combination with standard~     immunosuppressive medications, followed by a routine stem cell transplant in order to assess~     whether or not it is as effective as myeloablative high dose chemotherapy and transplant.~   "
86419|NCT02435888|"~     Predictive equations are the main clinical tool for determining resting energy expenditure~     (REE). Thus, it is important to investigate the accuracy and agreement of these equations in~     different populations and context of diseases. The purpose of this study is to investigate~     the accuracy and agreement of predictive equations of REE in overweight women with polycystic~     ovary syndrome (PCOS). The REE of all participants was measured (mREE) by means of indirect~     calorimetry and predicted (pREE) through ten equations basing on the anthropometric~     parameters (Harris & Benedict, WHO/FAO/UNU including weight, WHO/FAO/UNU including weight and~     height, Owen, Mifflin-St. Jeor, Institute of Medicine, Ireton-Jones, Müeller, De Luis and~     Lazzer).~   "
86420|NCT02435875|"~     Impaired baroreflex sensitivity (BRS) is a marker of autonomous dysfunction, which may play~     an important role in the long-term development of hypertension. Perioperative patients with~     hypertension is rapidly growing in all populations worldwide. However, no study has reported~     the values of BRS in this cohort. The aim of this study was to estimate the value of BRS for~     hypertension in a surgery cohort.~   "
86421|NCT02435862|"~     A Phase 2, Randomized, Double-masked, Placebo-controlled Multicenter Clinical Trial Designed~     to Evaluate the Safety and Efficacy of Luminate in Inducing PVD in Subjects with~     Non-Proliferative Diabetic Retinopathy.~   "
86422|NCT02435849|"~     This is a single arm, open-label, multi-center, phase II study to determine the efficacy and~     safety of CTL019 in pediatric patients with r/r B-cell ALL.~   "
86423|NCT02435836|"~     The primary objective of the study was to determine the safety of aripiprazole administered~     long-term in doses ranging from 10 to 30 mg per day as a maintenance therapy in subjects with~     chronic or first episode of schizophrenia. Information on the continued efficacy of~     aripiprazole was also gathered in this long-term trial (until 31 Dec 2012 or until~     aripiprazole was otherwise available through marketed means and/or reimbursed).~   "
86424|NCT02435823|"~     This is a prospective multi-center, single arm, non-randomized study. It is designed to~     evaluate the safety of the PulseRider® in patients undergoing treatment for bifurcation~     intracranial aneurysms.~   "
86443|NCT02435576|"~     The primary and general objective of the clinical introduction of the SFP as the current~     standard of care is to improve the quality of radiotherapy for head and neck cancer patients~     by reducing radiation-induced side effects without hampering treatment efficacy in terms of~     locoregional tumour control and overall survival and to systematically evaluate the~     beneficial effect of newly introduced radiation technology for this particular group of~     patients. The clinical introduction of the SFP will allow for a systematic and broad scale~     quality improvement cycle for head and neck cancer patients treated with radiotherapy. In~     fact, this methodology can be considered a kind of quality circle for the clinical~     introduction of new radiation techniques, aiming at continuous efforts for further~     improvement.~   "
86425|NCT02435810|"~     Background:~      - Inflammation is how the body reacts to infection or injury. . Infections or inflammation in~     the brain and nerves can be serious. There aren t always good tests to detect this.~     Researchers want to learn more about how diseases affect the brain and nerves to develop~     better tests and treatments.~      Objective:~      - To learn more about how inflammation and infections hurt the brain and nervous system.~      Eligibility:~      - People at least 2 years old with a diagnosis or suspected diagnosis of nervous system~     infection or inflammation.~      Design:~        -  For some participants, a clinician outside of NIH will collect blood, tissue, and other~          samples. These will be sent to NIH and analyzed.~        -  Other participants will have several visits to NIH. Children may not have all these~          tests.~        -  Participants will have:~        -  Medical history.~        -  Physical and neurological exam.~        -  Blood and urine samples collected.~        -  Saliva collected. They will chew on a piece of sterile cotton for one minute.~        -  Magnetic resonance imaging (MRI) scan. The scanner is a metal cylinder in a strong~          magnetic field. Participants will lie on a table that slides in and out of the cylinder.~          Participants will get a contrast agent through an intravenous (IV) catheter during the~          MRI. A needle will be used to guide a thin plastic tube (catheter) into an arm vein.~        -  Lumbar puncture. Skin will be numbed and a needle will be inserted into the space~          between the bones in the back. Fluid will be removed.~        -  Some participants may have optional study procedures. These may include eye tests,~          memory and thinking testing, tests with electrodes on the head, or skin biopsy.~   "
86426|NCT02435797|"~     To evaluate whether nicorandil as an adjunctive therapy for acute myocardial infarction (AMI)~     reduces reperfusion injury.~   "
86427|NCT02435784|"~     The Two-Way Communication Checklist (2-COM) is a communication tool developed by van Os et~     al. (2002). It aims to provide an opportunity for patients to voice their needs and problem~     to minimize the discrepancy and miscommunication between patient and professional carer. In~     this randomized controlled trial, the investigators aim to examine whether using 2-COM~     checklist would lead to improvement in first episode psychosis patient's overall~     satisfaction, change in treatment option in clinicians and consultation time.~   "
86428|NCT02435771|"~     Vitamin D insufficiency is an increasing trend in the United States. According to the NHANES~     data collection there was a near doubling of patients with vitamin D deficiency in 10 years.~     Vitamin D deficiency is associated with several adverse outcomes such as increased fractures,~     certain microbial diseases, cardiovascular diseases, and metabolic dysfunction. The~     increasing prevalence of vitamin D deficiency has been attributed to the increasing~     prevalence of obesity. Several studies have shown that obese patients have lower 25-OH~     vitamin D (25-OHD) levels compared to nonobese patients and obese patients require more~     vitamin D compared to nonobese patients. The most commonly prescribed medication to replete~     vitamin D deficiency is oral ergocalciferol. To date, no prospective trials have been~     published to evaluate a standard protocol in the treatment of vitamin D insufficiency in~     adults.~   "
86429|NCT02435758|"~     TME (Total mesorectum excision) is the golden standard of radical resection for mid-low~     rectal cancer. However, the damage of pelvic autonomic nerve following with TME principle~     will lead to high incidence of urinary and sexual function disorder. PANP (pelvic autonomic~     nerve preservation) surgery played a role in decreasing incidence of urinary and sexual~     function disorder. However, 32%-44% patients still suffered from urinary and sexual function~     disorder when underwent open (O-PANP-TME) or laparoscopic PANP TME surgery (L-PANP-TME).~      In the early stage of work, the investigators performed preservation of Denovilliers' fascia~     in L-PANP-TME to discuss the protection of urinary and sexual function of male mid-low rectal~     cancer patients. The results showed that preservation of Denovilliers' fascia in L-PANP-TME~     significantly decreased incidence of urinary and sexual function disorder. In order to~     further confirm the early work, the investigators design a multicenter randomized controlled~     clinical trial to compare differences in urinary and sexual function protection and long-term~     outcomes between preservation and excision of Denovilliers' fascia in L-PANP-TME.~   "
86430|NCT02435745|"~     Ehlers-Danlos Syndrome (EDS) is a clinically and genetically heterogeneous group of inherited~     connective tissue disorders characterized by joint hypermobility, skin hyperextensibility,~     and tissue fragility. EDS features such as genetically related cartilage defects,~     craniofacial abnormalities and increased pharyngeal collapsibility have been proposed to~     cause obstructive sleep apnoea (OSA). There is evidence from studies based on questionnaires~     that EDS patients might be more frequently affected by OSA and sleep disturbances than the~     general population. However, the actual prevalence of OSA in patients with EDS is unknown.~      Aortic root dilation and dissection are common complications of EDS and little is known about~     the underlying risk factors. Preliminary evidence suggests a link with OSA but this has not~     yet been investigated.~      The primary objective of this study is to assess the prevalence of OSA in EDS-patients (100)~     compared to a matched control group (100). The secondary objective of this pioneer study is~     to assess whether there is a relationship between OSA severity and aortic~     diame-ter/craniofacial abnormalities in EDS patients.~   "
86431|NCT02435732|"~     Limiting brain death-induced organ injury through a systemic anti- inflammatory medical~     management should allow for improvement in the quality of transplanted organs, and as a~     result, clinical improvement in post-transplant outcomes represented by a decrease in the~     incidence of delayed graft function (DGF) after transplantation.~      The specific aim is to evaluate the effect of C1INH (CINRYZE) as a donor pre-treatment~     strategy to decrease systemic inflammation and decrease the incidence of DGF in Expanded~     Criteria Donors (ECD), currently identified as donors with Kidney Donor Profile Index (KDPI)~     over 85%.~   "
86455|NCT02435420|"~     This is a retro-prospective, single arm, sequential enrolment study to collect relevant~     clinical and radiological data in at least 156 subjects, at up to 10 sites in Australia, who~     have been implanted with the EMPERION™ Modular Hip System in primary THA procedures to assess~     its safety and efficacy over 5 years post-surgery.~   "
86456|NCT02435407|"~     There is a paucity of research evaluating the effectiveness of a multidisciplinary approach~     in an outpatient clinic setting in the management of feeding problems in children diagnosed~     with ASD. Current behavioural interventions geared to address this problem can be labour~     intensive and costly. The SOS approach for managing feeding problems in children has been~     adopted internationally. Thus establishing its effectiveness will be useful in providing~     evidenced based interventions for feeding difficulties in ASD.~   "
86432|NCT02435719|"~     Ministry of Health through the National Medical Stores has supplied alcohol-based handgels to~     the different health facilities in Uganda for the health care providers to use during~     clinical care. However, constant stock-outs and or limited supplies remains the main~     constraint faced by the hospitals. Thus the handgels are generally used by a few of the~     senior health care providers.~      The promotion of bedside, antiseptic handrubs largely contributes to the increase in~     compliance and sustained improvement of hand hygiene compliance reduces Health care acquired~     infections (HCAIs), but it is not yet established how cost- effective the intervention is in~     a a rural Ugandan hospital where funds are severely rationed and, which serves over 4 million~     people in over 15 districts in Uganda. An evaluation of an intervention's cost-effectiveness~     is a crucial factor in whether the government will be prepared to fund the intervention and~     sustain it.~      This WardGel study thus aims to assess the cost-benefit of providing hand gel for all health~     care workers in Mbale Regional Referral Hospital.~   "
86433|NCT02435706|"~     A randomized controlled trial of 12-month duration to compare gingival margin location,~     buccal horizontal ridge dimensions, and interproximal crestal bone levels following two~     surgical approaches for immediate placement of implants in the esthetic zone: one involving~     flap elevation and another using a flapless protocol.~   "
86434|NCT02435693|"~     Evaluation of Pharmaceutical Care Program for Type 2 diabetes mellitus in Dhule~      Objectives:-~        1. To evaluate Pharmaceutical care program in Type2 diabetics.~        2. To evaluate the impacts of Pharmaceutical care on quality of life (QOL) in patient with~          Type-2 Diabetes Mellitus.~        3. To study the prevalence of Type2 diabetics cases in Dhule.~        4. To study the Assessment of different type of adverse drug reactions (ADRs). In Type2~          diabetics.~        5. To evaluate the Drug Drug intereaction in Type-2 Diabetes Mellitus.~        6. To study the impacts of Pharmaceutical care program on glycemic control in patients with~          Type-2 Diabetes Mellitus.~        7. To study the Drug utilization pattern in Type-2 Diabetes Mellitus in civil hospital~          Dhule.~        8. To compare the efficiency of Pharmaceutical care program and drug in patients with~          Type-2 Diabetes Mellitus.~        9. To study the Pharmaco-economic evaluation in Type-2 Diabetes Mellitus patient's.~       10. To increase the patient compliance and positive attitude of patients towards the~          diabetes disease by counseling.~   "
86435|NCT02435680|"~     To determine whether MCS110 antibody therapy improves the efficacy of carboplatin and~     gemcitabine (carbo/gem) in advanced TNBC patients~   "
86436|NCT02435667|"~     The objective of this proposal is to determine the effect of resistance exercise training on~     locomotor muscle function, exercise capacity, exertional symptoms, and quality of life in HF~     patients with preserved ejection fraction (HFpEF).~   "
86437|NCT02435654|"~     In this study,investigators will recruit 100 DSM-Ⅴdefined EOS Han patients, older than 7~     years old and onset of illness before 17 years old, and all EOS patients will receive a~     8-week systematic olanzepine titration treatment and a battery of assessments of treatment~     effect and safety. Blood olanzepine plasma concentration will be tested regularly and~     genotyping of 8 polymorphisms of 5-HTR2A, DRD2 and COMT genes will be conducted by Polymerase~     Chain Reaction （PCR）, Restriction Fragment Length Polymorphism (RFLP) and TaqMan probes~     genotyping technology. The aim of the study is to explore the predictive factors on~     olanzepine treatment response in EOS, which can guide the individualized treatment and~     improve the cure rate of EOS in clinical setting.~   "
86438|NCT02435641|"~     The current study has the following objectives:~        1. To determine predictors of time 2 and 3 (3 and 6 months post-ICU admission) depression,~          PTSD, satisfaction with life and quality of life in both patients and caregivers, after~          controlling for injury severity and impairment.~        2. To determine factors associated with patient and caregiver satisfaction with medical~          care at time 2 and time 3.~      The investigators would thus be able to identify the best time point for intervention~     delivery, intervention targets, and risk factors for chronic psychological distress.~   "
86439|NCT02435628|"~     This is a prospective study through the NF clinic at Massachusetts General Hospital that will~     examine the relationship between psychosocial factors, health literacy, and satisfaction with~     the medical visit in adults with NF1, NF2, and Schwannomatosis. A total of 89 participants~     will be enrolled in the study.~   "
86440|NCT02435615|"~     Dengue is the most common viral illness spread by mosquitos. It is important to diagnose~     dengue to prompt adequate therapy and initiate local mosquito control. Easy to use point of~     care tests are needed to improve dengue diagnosis. Oral fluid collection may be a simple,~     non-invasive way to diagnose dengue in the community. However, it is currently unknown if~     oral fluid is an accurate way to diagnose dengue and if the use of a specialized oral fluid~     collector could help to improve dengue diagnosis. In this study, the investigators will~     analyze the oral fluid of suspected dengue patients compared to serum samples for dengue~     diagnosis. From this information the investigators will be able to determine if oral fluid is~     a convenient way to diagnose dengue and if the oral fluid collector aids in improving~     diagnosis.~   "
86441|NCT02435602|"~     This study evaluates the role of narrow band imaging (NBI) endoscopy compared with Lugol~     chromoendoscopy in the early detection of esophageal cancer in patients with prior head and~     neck cancers.~   "
86442|NCT02435589|"~     The purpose of this study is to investigate the effectiveness of a systematic approach to~     pain assessment in the critically ill patients' outcome The investigators hypothesize that,~     patients who will undergo systematic pain assessment and they will have their results~     notified to physicians and nurses, will demonstrate favorable effects on pain intensity, more~     efficient use of sedatives and analgesics, duration of mechanical ventilation, length of ICU~     stay, mortality, adverse events and complications, in relation to patients who will receive~     standard care alone. Moreover it is expected that they will demonstrate altered levels of~     plasma neuropeptides and biochemical markers in peripheral blood.~   "
86457|NCT02435394|"~     Asthma, one of the most common pediatric illnesses, is optimally managed according to~     National Heart Lung and Blood Institute (NHLBI) guidelines yet this is not often done in~     primary care. This project is to develop and test the effects of using a module for guideline~     based care in the Child Health and Development Interactive System (CHADIS) online system by~     prompting and incorporating patient symptom/control and adherence data from standard~     questionnaires to inform visits and providing automated patient specific education and Asthma~     Action Plans in individual Care Portals.~   "
86444|NCT02435563|"~     Ticagrelor is a new generation antiplatelet agent with higher efficacy as compared to~     clopidogrel and prasugrel in treatment of patients with moderate and high ischemic risks.~     Ticagrelor is active as such and its hepatic metabolism by CYP3A generates also an active~     metabolite. Because of the remarkable progress in HIV therapies the number of older age~     patients is on the rise, requiring adequate cardiovascular treatment. Since frontline HIV~     therapies include ritonavir, a strong inhibitor of CYP3A enzyme, ticagrelor is~     contraindicated in these patients because of the expected interaction and bleeding risk. A~     lower efficacy of clopidogrel and prasugrel, which are both pro-drugs, in the presence of~     ritonavir has been already demonstrated. Therefore, administration of a lower dose of~     ticagrelor may be a good alternative in HIV patients in order to lessen the impact of this~     pharmacokinetic interaction. The aim of this study is to adjust the dose of ticagrelor in~     case of co-treatment with ritonavir to achieve the same pharmacokinetic profile as~     administered alone using a physiologically-based pharmacokinetic (PBPK) model.~      As the first step, a pharmacokinetic (PK) model for ticagrelor and its active metabolite will~     be created based on available in vitro and in vivo parameters in healthy volunteers.~      An open-label, 2 sessions cross over study will be conducted with 20 healthy male volunteers~     at Clinical Research Center (CRC) of Geneva University Hospitals (HUG). During the first~     session of the clinical trial, a single dose 180 mg ticagrelor will be administered to the~     volunteers and obtained pharmacokinetic data will be fitted into the model for optimization.~     Thereafter a simulated trial by the Simcyp® simulator in presence of a single dose 100 mg~     ritonavir will allow evaluating the impact of CYP3A inhibition on the concentration-time~     profile of ticagrelor and its active metabolite. The necessary dose of ticagrelor to minimize~     the magnitude of this interaction will be calculated. This new dose will be co-administered~     with ritonavir in the same volunteers during the second session of the clinical trial. The~     purpose is to obtain the same PK profile with single dose of 180 mg ticagrelor administered~     alone and with an adapted dose of ticagrelor co-administered with a single dose 100 mg~     ritonavir. Moreover, the pharmacodynamic effect of ticagrelor will be measured in both~     sessions of the clinical trial using two specific platelet function tests: the~     VAsodilator-Stimulated Phosphoprotein assay (VASP) and VerifyNow® P2Y12. With the same PK~     profile, the same pharmacodynamic activity is expected. The modulation of activity of CYP3A~     and P-gp by ritonavir will be also monitored using micro dose midazolam and fexofenadine as~     probe substrates.~      The purpose of this study is to use the Simcyp® Simulator mechanistic PBPK modeling to~     broaden the application field of ticagrelor, especially in HIV patients. Since PK models are~     often created after clinical observations, the prospective aspect of this study is of~     particular value as the model will be first created and then applied to an unknown clinical~     scenario.~   "
86445|NCT02435550|"~     The purpose of this study is to use genomic information from individual patients to create~     simulation avatars that will be used to predict novel drug combinations with therapeutic~     potential.~   "
86446|NCT02435537|"~     The current study investigated the effect of adding dexmedetomidine to intrathecal morphine~     for postoperative analgesia in cancer patients undergoing major abdominal surgery.~   "
86447|NCT02435524|"~     The time between birth and age 24 months provides a unique opportunity to impact the~     long-term health and development of children through improved infant and young child feeding~     practices. In Burkina Faso, the prevalence of exclusive breastfeeding is currently around 25%~     in infants younger than six months.~      The purpose of this study is to evaluate whether the Alive & Thrive intervention package,~     consisting of interpersonal counselling and community mobilisation activities, can increase~     the exclusive breastfeeding rate among infants younger than six months to at least 50% using~     a cluster randomised design.~   "
86448|NCT02435511|"~     CommunityRx is a health information technology-based innovation that, starting with the~     patient-health care provider encounter, facilitates self-care coordination for patients,~     caregivers, and providers. The CommunityRx database interfaces with electronic medical~     records to provide patients with a HealtheRx. A HealtheRx is a list of community-based~     self-care resources tailored to the patients health needs (e.g., a person with diabetes~     receives information about podiatrists, nutrition classes, and other resources need to manage~     diabetes). CommunityRx aims to measurably improve health and health care while reducing~     health care costs especially in underserved health care settings. Specifically, the proposed~     research aims to 1) evaluate the impact of CommunityRx on health care utilization, cost,~     health, and patient-centered outcomes for program participants compared to controls; 2)~     examine the flow and spread of information to and through primary agents including: program~     participants, community health information experts, healthcare providers, and community-based~     service providers (businesses and organizations providing self-care resources); and 3) build~     and use an agent-based model to test the distributed impact, including economic effects, of~     CommunityRx system adoption on the demonstration area and predict performance over time by~     conducting experiments that vary assumptions about agent, environment, and population-level~     characteristics.~   "
86449|NCT02435498|"~     This study's objectives are as follows:~      1. To evaluate the utility of a website to provide information and guidance about pain~     management in children 2. To educate parents about the pathophysiology of pain, proper use of~     analgesic medications and signs of pain in children 3. To reduce the functional impact of~     pain in children following treatment for fracture 4. To endow parents with confidence to~     manage their child's pain at home 5. To dispel misconceptions about the use and safety of~     analgesics in children 6. To increase awareness of complications of fractures such as~     compartment syndrome~   "
86450|NCT02435485|"~     Patients with degenerative lumbar spondylolisthesis usually are present with low back pain,~     muscle spasm and weakness, radicular symptoms, intermittent claudication, insomnia, even~     urine or stool incontinence. There are very few research on the effectiveness of core spine~     stabilization exercise, balance training, and the balance effect while wearing lumbar corset~     in these patients.~      Purpose: To investigate 1) the correlation of dynamic balance and the degree of disability~     with the characteristics of spinopelvic alignment. 2) potential predictors of dynamic~     spino-pelvic instability, 3) the effectiveness of core spine stabilization exercise, balance~     training and balance effect of the wearing of lumbar corset in patients with degenerative~     lumbar spondylolisthesis .~   "
86451|NCT02435472|"~     The AS RCT study is a randomized controlled trial of 16-weeks aerobic exercise (home-based~     walking) vs. usual care among 150 men with prostate cancer on active surveillance.~   "
86452|NCT02435459|"~     The aim of this research is to compare the clinical outcome of amalgam restorations placed in~     conjunction with three different lining protocols, each of which represents a different~     therapeutic concept.~   "
86453|NCT02435446|"~     Computed tomography scan (CT) is routinely used for the diagnosis and the pre-operative~     assessment of otosclerosis.~      The cone-beam computed tomography (CBCT) is a imaging technique with reduced irradiating and,~     therefore, could replace the CT.~      In this study, a CBCT will be proposed to all patients undergoing a CT exam for the diagnosis~     and/or the pre-operative assessment of an otosclerosis.~      The results of the CBCT will be compared to those of the CT scan.~   "
86454|NCT02435433|"~     The purpose of this study is to evaluate the safety and efficacy of ramucirumab in~     participants with hepatocellular carcinoma (HCC) and elevated baseline alpha-fetoprotein.~     Participants will be randomized to ramucirumab or placebo in a 2:1 ratio (Main Global Cohort~     and China Maximized Extended Enrollment {ME2} Cohort). Participants may also receive~     ramucirumab if eligible to be enrolled in Open-Label Expansion (OLE) Cohort.~   "
86460|NCT02435355|"~     Background: Continuous Positive Airway Pressure (CPAP) remains the reference treatment for~     moderate to severe forms of the Sleep Apnea/Hypopnea Syndrome (SAHS). Compliance to the~     treatment appears to be a key factor to improving health status of these patients.~      Methods: The investigators conducted a multicenter, prospective, randomized, controlled,~     parallel group trial of standard support completed or not within 3 months of coaching~     sessions for newly diagnosed SAHS patients starting CPAP therapy. The coaching session~     consisted of 5 sessions of telephone-based counseling by competent staff. The primary outcome~     was the proportion of patients using CPAP more than 3 hours per night for 4 months; the~     secondary outcome was mean hours of CPAP usage in the 2 groups.~   "
86461|NCT02435342|"~     The primary purpose of this study is to examine safety outcomes in active plaque psoriasis~     patients after systemic administration of dalazatide. Clinical outcome measures will also be~     assessed.~   "
86462|NCT02435329|"~     This study is part of a research project for a University MD Program. This is an~     observational study aimed at comparing the differences in bone metabolism and~     microcirculation in patients with type 2 diabetes mellitus (with and without diabetic~     neuropathy and Charcot foot) with healthy subjects.~      Diabetes is gradually becoming a global epidemic along with its associated complications.~     Diabetes can affect several systems in our body particularly the eyes, nerves and the~     kidneys. The damaging effects occur at the level of the small blood vessels~     (microcirculation) that supply these vital structures. Normally, the inner lining of these~     blood vessels (endothelium) plays a very important role in maintaining adequate blood flow.~     The endothelium releases a chemical substance called nitric oxide, which relaxes these small~     blood vessels thereby ensuring sufficient blood supply to these key structures. Nitric oxide~     also prevents blockage of these vessels. Any form of metabolic stress like hyperglycaemia~     (raised blood sugar as seen in diabetes) can cause abnormal changes in the normal behaviour~     of the endothelium (endothelial dysfunction). Therefore hyperglycaemia promotes endothelial~     dysfunction by lowering nitric oxide levels, which may lead to diabetic complications like~     diabetic retinopathy (eye damage), nephropathy (kidney damage) or neuropathy (nerve damage).~      In addition, patients with diabetes also suffer from osteoporosis (thinning of bones).~     Osteoporosis is a bone disorder characterised by a reduction in bone mineral content leading~     to an increased risk of developing fractures. The increased risk of fractures in patients~     with type 2 diabetes is attributed to poor bone quality resulting from the harmful effects of~     high blood glucose. Studies have also shown that nitric oxide has a bone protective effect as~     demonstrated by its ability to prevent bone fragmentation and improve bone strength.~      Study of markers of endothelial function and bone metabolism will facilitate a better~     understanding about the origin of diabetic complications. This will aid in the development of~     novel therapeutic agents that target the harmful triggers in diabetes and eventually may~     prevent and retard the onset of the debilitating diabetic complications.~   "
86463|NCT02435316|"~     This is a prospective, randomized controlled, crossover trial comparing the effectiveness one~     two curricular designs to teaching peripheral blood smears to residents.~   "
86464|NCT02435303|"~     The purpose of this study is to determine whether Sildenafil is effective in the treatment of~     sustained pulmonary artery hypertension after corrected mitral valve disease.~   "
86465|NCT02435290|"~     It is a cross-sectional study examining a random sample of in- and out-patients, with proven~     malignant disease receiving chemotherapy, over a period of 6 months from the start of the~     study who visit the Oncology department, Ain Shams University Teaching Hospitals. The effect~     of some risk factors on the prescribing error will be studied; these risk factors include the~     following: Tumor type ,Cancer stage ,type of comorbid illness ,type of medication , type of~     anti-cancer treatment , number of abnormal lab data ,type of abnormal lab data , the number~     of drugs in the treatment regimen , the number of side effects after chemotherapy~     administration, the age of patient ,the dosing frequency of anticancer ,the route of~     administration .~      Summary statistics are performed to describe patient characteristics , frequency, types and~     classification of medication error; and frequency with which Medication errors occur.~      Logistic regression will be applied to the collected data to perform a predictive relation~     between the risk factors which may be (categorical, continuous, or discrete) and the~     prescribing errors which are (categorical).~   "
86466|NCT02435277|"~     Study NS-0100-01E is an extension of Study NS-01-0100 designed to assess safety and longer~     term effect (i.e., additional 8 weeks) of various fixed-dose leucine and metformin~     combinations (NS-0100) versus standard metformin monotherapy on glycemic control in subjects~     with type 2 diabetes using HbA1c as the primary endpoint.~   "
86467|NCT02435264|"~     Recent national statistics revealed that the prevalence of lifestyle related diseases is~     increasing in Singapore. Much of this disease burden can be prevented using lifestyle~     strategies. A large proportion of Singaporeans consume foods prepared by outside vendors.~     These foods are typically high in refined-grains and saturated fat, and choices for healthier~     foods like brown-rice often do not exist. The Healthier Dining Program managed by the Health~     Promotion Board of Singapore, seeks to assess if increasing the availability of healthier~     food options increases consumer consumption of these foods. The investigators aim to evaluate~     this program implemented on the National University of Singapore campus. A major output of~     this evaluation will be the assessment of the barriers and enablers to programme~     implementation which will provide guidance for the widespread implementation of the~     programme. Additionally this evaluation can lead to detailed recommendations on policies and~     programmes relevant to non-home food environments. This is important as successful~     interventions have the potential of improving the eating behaviors of a vast majority of the~     population.~   "
86468|NCT02435251|"~     The purpose of this research is to study changes in weight, body mass index, and percentage~     of fat following orthopaedic knee or shoulder surgery.~   "
86469|NCT02435238|"~     Non interventional study collecting patient reported outcomes. The study aims to assess the~     disease burden of chronic urticaria patients and to record the therapies used in daily~     clinical practice in the UK and the impact they have on the quality of life and work~     productivity of individual patients.~   "
86470|NCT02435225|"~     The investigators propose to study 30 adolescents with bipolar disorder, not otherwise~     specified (BD NOS) and a family history of Bipolar I Disorder (BD) at baseline with rs-fMRI~     (functional magnetic resonance imaging) and functional connectivity (FC) analyses and compare~     data with previously acquired rs-fMRI and FC data from 20 age- and gender-matched healthy~     controls (HC). Subjects will then undergo a 12-week Mindfulness based stress reduction- teen~     (MBSR-T) intervention and be reassessed and rescanned. The intervention and scanning will~     take place in groups of 6-8 subjects/group/year over the 4 years. This proposal will be a~     natural progression of past research, while extending the investigators' expertise to include~     advanced FC analyses and mindfulness based interventions in youth with mood dysregulation.~     The investigators will also integrate trainees into the imaging and therapy components of~     this study, furthering our mission of mentoring the next generation of innovative researchers~     who will push the field forward.~   "
86471|NCT02435212|"~     This is a randomized, open-label, multicenter, two arm, phase II study to evaluate treatment~     compliance and change in serum ferritin of a deferasirox granule formulation and a~     deferasirox DT formulation in children and adolescents aged ≥ 2 and < 18 years at enrollment~     with any transfusion-dependent anemia requiring chelation therapy due to iron overload, to~     demonstrate the effect of improved compliance on iron burden.~      Randomization will be stratified by age groups (2 to <10 years, 10 to <18 years) and prior~     iron chelation therapy (Yes/ No). There will be two study phases which include a 1 year core~     phase where patients will be randomized to a 48 week treatment period to either Deferasirox~     DT or granules, and an optional extension phase where all patients will receive the granules~     up to 5 years. Patients who demonstrated benefit to granules or DT in the core phase, and/or~     express the wish to continue in the optional extension phase on granules, will be offered~     this possibility until there is local access to the new formulation (granules or FCT) or up~     to 5 years, whichever occurs first.~   "
86472|NCT02435199|"~     The study consists of two periods, the Screening Period (~3 weeks) and Treatment Period (12~     weeks).~      Eligibility for the study will be determined by Screening tests, physical examination/medical~     history, and fulfilment of eligibility criteria including assessment of pain completed during~     the Screening Period. Potential participants will be required to provide written informed~     consent prior to any study-specific Screening procedures being performed.~      Following Screening assessments, patients will be randomized to receive either EMA401 300 mg~     BID or placebo.~      Patient study visits during the Treatment Period are at the end of baseline/randomization~     visit, and end of Weeks 3, 6, 9, and 12, for assessments.~   "
86473|NCT02435186|"~     The study objective is to investigate the efficacy and safety of p53 combined with~     chemotherapy (cisplatin and paclitaxel) in treatment of recurrent Ovarian Epithelial Cancer,~     Fallopian Tube Cancer, and Primary Peritoneal Cancer.~   "
86474|NCT02435173|"~     This study is designed to explore CDZ173, a selective PI3Kδ inhibitor, in patients with~     genetically activated PI3Kδ, i.e., patients with APDS/PASLI. The study consists of two parts.~     Part I is the open label part designed to establish the safety and pharmacokinetics of CDZ173~     in the target population, as well as to select the optimal dose to be tested in part II. Part~     II is designed to assess efficacy and safety of CDZ173 in this population.~   "
86475|NCT02435160|"~     The aim of our study is to investigate the efficacy and mechanism in fecal microbiota~     transplantation in the treatment of ulcerative colitis. About 20 Ulcerative Colitis (UC)~     patients will be recruited into our trial for Fecal Microbiota Transplantation (FMT)~     treatment,the safety and efficacy of FMT will be observed.~   "
86476|NCT02435147|"~     The purpose of this study is to validate the long-term benefit of denosumab for osteoporosis~     treatment in a real-world clinical practice setting. We hypothesize that continued therapy~     (36+months) with denosumab will increase both trabecular bone score (TBS) and femur strength~     index (FSI) and reduce fracture and other bone health risks among post-menopausal women with~     osteoporosis.~   "
86477|NCT02435134|"~     Hip internal rotation range of motion (HIRROM) assessment is performed to assess the mobility~     of the hip. The assessment is typically done manually (manual testing), which induces large~     variability in the results between and within testers. An initial version of an examination~     chair (EC1) was recently developed with the aim to minimize the variability of testing~     results for HIRROM assessments. A new version of the examination chair (EC2) has been~     implemented in order to individualize the testing protocol and will be validated in this~     study.~   "
86478|NCT02435121|"~     Primary Objective:~      To determine objective response rate (ORR).~      Secondary Objectives:~      To assess duration of response (DR), progression free survival (PFS) and overall survival~     (OS).~      To evaluate global safety profile. To determine pharmacokinetic profile. To assess clinical~     utility of fluorescence in situ hybridization (FISH) assay in selection of patients with~     mesenchymal-epithelial hybridization (MET) gene amplification.~      To assess lung cancer symptoms, health-related quality of life and treatment satisfaction.~   "
86479|NCT02435108|"~     This is a pilot study of crizotinib in patients with c-MET positive gastric adenocarcinoma.~   "
86480|NCT02435095|"~     Continuation of antipsychotic drug treatment for at least 12 months after remission of the~     first psychotic episode represents the gold clinical standard, and it is recommended by all~     international treatment guidelines. Numerous studies have shown that the risk of relapse is~     significantly increased, if drug treatment is terminated prematurely. However, only a~     minority of patients achieve functional remission, even if they fully comply with treatment.~     Long-term adverse effects of the currently available drugs, specifically brain grey matter~     loss and development of supersensitivity psychosis, might outweigh their benefits. Thus, the~     current standard of long-term maintenance antipsychotic treatment, which has the primary goal~     of relapse prevention, has to be questioned. Here the investigators hypothesize that~     intermittent treatment (experimental) with antipsychotics, which is directed exclusively~     against the positive symptoms of Schizophrenia, is associated with less loss in total grey~     matter volume than maintenance treatment (control). Furthermore, the investigators~     hypothesise that this targeted treatment approach is associated with better functional~     outcome (fewer negative symptoms, better cognitive performance, better quality of life) than~     continuous antipsychotic treatment,although the latter is initially associated with fewer~     relapses.The aim of the present study is to compare two different drug therapies -maintenance~     therapy versus on-demand, intermittent therapy- in terms of their treatment's success and the~     structural changes in the brain.~   "
86481|NCT02435082|"~     The objective of this patient registry is to collect and analyze physiological data~     associated with baseline and brain injury identified in standard clinical practice (Normal~     Values, Recovery Curves, Correlation between Symptoms and Other Tests, NCI Index), and to~     assess health economics.~   "
86504|NCT02434783|"~     Current evidence cannot explain the clinical features of peripheral arterial disease only~     from the principle of reduced blood flow. Explanations have therefore in addition been linked~     to mitochondrial dysfunction of skeletal muscles.~      This study will elucidate whether there is a relation between clinical variables of the~     different levels of arterial insufficiency in peripheral arterial disease and mitochondrial~     respiratory capacity.~   "
86505|NCT02434770|"~     The purpose of this study will be to evaluate whether a bivalent oral polio vaccine (bOPV)~     manufactured by Beijing TiantanBio has a similar immunogenicity profile to a WHO~     pre-qualified bOPV.~   "
86482|NCT02435069|"~     There is a surgical procedure to help children with intractable fecal incontinence gain~     continence for stool through construction of a tube that connects the abdominal wall to the~     colon near or through the appendix. This tube allows easy administration of enema solution~     into the first part of the colon. Putting enema solution through that tube into the colon is~     called an antegrade continence enema or ACE and has been shown to work well in helping some~     but not all children prevent stool accidents. The purpose of this study is to compare a large~     volume ACE flush using a salt water solution called normal saline with a small volume ACE~     flush using liquid glycerin. The aims of this study are to: 1) find the most effective dose~     and flush frequency of each solution; 2) compare which solution given at the best dose takes~     the least amount of time to clear the colon of stool, has the least side effects, and is the~     most effective in preventing stool accidents; and 3) to determine if administration of either~     of the ACE flushing solution affects colon health and the bacteria in the colon.~   "
86483|NCT02435056|"~     Appropriate delivery of quality healthcare requires constant monitoring of the patient during~     follow up, particularly in the presence of chronic diseases. This approach can be further~     improved if leading edge tools supporting diagnosis, as well as prediction, identification~     and monitoring of adverse events are available. COMOESTAS aims to develop an innovative~     Information Communications Technology (ICT) system that allows patients with a chronic~     condition to receive continuous and personalized treatment. The whole system is based on an~     advanced, all in one Alerting and Decision Support System that follows patients from the~     diagnosis and supports the physician in managing the therapy, controlling relevant events~     impacting on patient safety and activating specific procedures if selected thresholds are~     exceeded. In the frame of chronic neurological disorders, Medication Overuse Headache (MOH)~     is a common condition and a major cause of disability. MOH is curable, but its outcome is~     hampered by a high risk of relapse. It is, therefore, a perfect example of a disorder that~     can benefit from an ICT-assisted approach developing innovative systems and services for~     monitoring chronic conditions. COMOESTAS goals will be achieved by improving and integrating~     the traditional paper headache diaries and calendars into an innovative ICT tool taking into~     account the complex issues that accompany this peculiar form of headache, which will make the~     patient a key node in the entire process.~   "
86484|NCT02435043|"~     The aim of NASTRU was to examine whether ten weeks of nature-based rehabilitation, as add-on~     to standard management, could influence post-stroke fatigue (primary outcome), depression,~     work ability or functional outcome (secondary outcomes), compared to controls.~   "
86485|NCT02435030|"~     This is a prospective non-therapeutic observational study in NP-C patients. The aim is to~     characterize the individual patient disease progression profile through the historical and 6~     months prospective evaluation of clinical, imaging, biological(biomarkers) and quality of~     life data.~      Patients will be offered enrollment into a Phase II/III study on arimoclomol at the end of~     the study.~   "
86486|NCT02435017|"~     Overall study design is to review National Health and Nutrition Examination Survey (NHANES)~     data 1999-2008 for nutrition risk according to kidney function. Substudies will be performed~     to review the association of nutrients and overall dietary intake compared to biomarkers~     available in NHANES during this period.~   "
86487|NCT02435004|"~     A prospective, single-arm, mono-centre pilot study to obtain preliminary information on the~     ability of Dorsal Root Ganglion Stimulation (DRGS) in alleviating the painful symptoms in~     patients with small fiber neuropathy (SFN).~   "
86488|NCT02434991|"~     This study is being done to assess the esophageal muscle (swallowing tube) in patients with~     and without achalasia to further understand and help direct the treatment for patients with~     achalasia.~   "
86489|NCT02434978|"~     The present study is a randomized controlled trial (RCT) that examines if the outcome of~     peptic ulcer bleeding could be improved by use of doppler-guided endoscopic treatment.~   "
86490|NCT02434965|"~     The purpose of this study is to investigate the safety and effectiveness of autologous human~     placental-derived stem cells (HPDSC) in combination with autologous cord blood in neonates~     with severe hypoxic-ischemic encephalopathy.~   "
86491|NCT02434952|"~     In Cambodia, falciparum is becoming more difficult to treat because drugs are becoming less~     effective. The investigators can help to try to prevent the spread of this resistant malaria~     by adding a drug that will make it more difficult for the mosquito to drink up the malaria in~     people's blood. If the mosquito cannot drink up the malaria, then the malaria cannot develop~     in the mosquito so it will not be able to inject malaria back into people when it bites. The~     drug the investigators will use is called primaquine.~      Primaquine commonly causes the red cells in the blood to break apart if they are weak. Red~     cells need enzymes to work properly and weak red cells have low amounts of an enzyme called~     glucose 6 phosphate dehydrogenase (G6PD). The investigators want to know if treating malaria~     with primaquine will be safe for the red cells. To do this study, the investigators need to~     know if a subject has low G6PD or not.~   "
86492|NCT02434939|"~     This clinical trial will inform of the role of Low dose ketamine in the acute treatment of~     severe painful sickle cell crisis in children in a day-case sickle cell centre. The primary~     aim is to determine whether Low dose ketamine is non inferior to morphine in the management~     of acute painful sickle cell crises. The specific objectives will be to determine the maximal~     change in NRS pain score following administration of ketamine and to examine the safety~     profile of ketamine compared to morphine in this population.~      The investigators hypothesize that low dose ketamine will result in similar effective pain~     control as morphine alone and will not be associated with an increase in adverse events.~   "
86546|NCT02434237|"~     Task-oriented repetitive movement can improve movement performance in patients with~     neurological or orthopedic lesions. The application of robotics can serve to assist, enhance,~     evaluate, and document neurological and orthopedic rehabilitation of movements. Arm therapy~     is used in neurological rehabilitation for patients with paralyzed upper extremities due to~     lesions of the central or peripheral nervous system, e.g. after stroke or spinal cord injury.~     The goal of the therapy is to recover motor function, improve movement coordination, learn~     new motion strategies (trick movements), and/or prevent secondary complications such as~     muscle atrophy, osteoporosis, and spasticity.~   "
86562|NCT02434029|"~     The purpose of this study is to prove the superiority of a 6-weeks treatment with budesonide~     effervescent tablets versus placebo for the induction of clinico-pathological remission in~     patients with acute eosinophilic esophagitis.~   "
86493|NCT02434926|"~     Fetoscopic surgery has been acknowledged to be a reliable procedure to correct several~     congenital anomalies e.g. shunt insertion in fetal bladder outlet obstruction, laser ablation~     of vessels in twin-twin transfusion syndrome (TTTS), balloon occlusion in congenital~     diaphragmatic hernia etc. The technique involves an introduction of small-caliber instruments~     into the amniotic cavity under ultrasound guidance. This procedure can be successfully done~     under either general anesthesia, regional anesthesia or local anesthesia with sedation. Each~     technique has both advantages and drawbacks.~      Several complications related to anesthetic after fetoscopic surgery can occur. For instance,~     pulmonary edema which is caused by intravenous fluid loading, irrigation fluid absorption or~     fluid flow through myometrium venous channel. Besides, maternal hypotension intraoperatively~     can arise from spinal anesthesia.~      The aim of the study is to report choice of anesthesia using in fetoscopic surgery in the~     tertiary care institute (Siriraj hospital) and incidence of complications which may relate to~     different anesthetic techniques.~   "
86494|NCT02434913|"~     This surgery involves the use of a finger joint replacement device for treatment of patients~     with certain kinds of arthritis (osteo - arthritis or post traumatic arthritis) and who~     expect to place their hands in heavy loading situations, or patients needing revision of a~     failed implant placed in the PIP joint. A joint replacement surgery is an operation where the~     arthritic joint is removed and a metal and plastic joint is inserted to replace the natural~     joint. The surgery is expected to last about 2 hours. The procedure is done in the operating~     room and requires general anesthesia or an axillary block. (General anesthesia affects the~     entire body and is accompanied by a loss of consciousness. An axillary block results in~     anesthesia of the hand and forearm only. A tourniquet is applied to the arm to prevent~     bleeding during the surgery.)~   "
86495|NCT02434900|"~     The Vitamin D and Angiogenic Marker Study 1:~      Vitamin D and angiogenic markers in early pregnancy. Epidemiology and associations to~     early-pregnancy miscarriage~   "
86496|NCT02434887|"~     The purpose of this study is to verify the effectiveness of the investigational product~     through Subjective Assessment and answered by volunteers.~   "
86497|NCT02434874|"~     The purpose of this pivotal study is to illustrate the safety and effectiveness of the~     StimGuard Sacral Nerve Stimulation (SNS) System in the treatment refractory urge~     incontinence. This is a prospective, randomized, controlled, multi-center, study in which 92~     subjects will receive a StimGuard SNS System.~   "
86498|NCT02434861|"~     The objective of this Open Label Study is to evaluate effects of Rolapitant IV solution, and~     its metabolite, on the pharmacokinetics (PK) of the P-gp substrate (digoxin), the BCRP~     substrate (sulfasalazine), and multiple cytochrome P450 (CYP) probe substrates in a healthy~     adult population.~   "
86499|NCT02434848|"~     Hepatitis B virus (HBV) infection can result in a greater risk of adverse outcomes in~     HIV-infected individuals, including more rapid progression to cirrhosis and associated~     complications such as hepatocellular carcinoma. For this reason, as well as the shared routes~     of transmission between the two viruses, UK and International guidance recommends that all~     HBV-negative HIV-infected individuals be offered vaccination against HBV. Unfortunately,~     response rates in this population can be as low as 17.5 - 40% to standard vaccination~     courses. To improve this response, strategies such as the use of double dose of standard~     vaccines (e.g. Engerix B) is recommended in several guidelines for previous non-responders,~     although there is currently limited evidence for this approach. An alternative strategy is to~     use vaccines with novel adjuvants such as Fendrix and observational clinical data in the~     Investigators HIV cohort suggests that response rates can be as high as 81% of individuals~     achieving HBV surface antibody (HBsAb) levels >100 in a group that did not respond to~     previous standard HBV vaccine courses. However, the cost of Fendrix is considerably higher~     than Engerix B and controlled trials are required to confirm whether this approach is~     warranted. Furthermore, insights into the potential mechanisms by which Fendrix may elicit~     better responses would be valuable in optimising future vaccine strategies in this~     population.~      The Investigators propose to conduct a randomised, open label, active-controlled pilot study~     comparing double dose Engerix B and Fendrix in HIV-infected non-responders to standard HBV~     vaccine courses, which will provide the necessary data to design and power a larger~     multicentre randomised controlled trial. Outcome measures will include the proportion of~     individuals seroconverting with HBsAb levels >100 following each vaccination course, the~     magnitude and quality of the HBV-specific CD4+ T-cell responses elicited by each vaccine and~     the durability of the HBsAb response at 1 year following the end of vaccination.~   "
86500|NCT02434835|"~     The purpose of this study is to evaluate the absorption, metabolism and excretion following a~     single oral dose of [14C]KWA-0711 to healthy male subjects.~   "
86501|NCT02434822|"~     The aim of the study is to generate safety and immunogenicity data with Shanchol in The~     Philippines~      Objectives:~        -  To describe the safety after each dose of Shanchol vaccine.~        -  To describe the immunogenicity after each dose of Shanchol vaccine.~   "
86502|NCT02434809|"~     The first purpose of this study is to test a new computer program that reduces the blurring~     in the cone-beam CT scan and helps the doctor to better locate the tumor. The investigators~     want to find out what effects, good and/or bad, that this has on the patient and the way we~     treat the cancer in the lungs.~      The second purpose of this study is to test how well this computer program tracks markers in~     the images, compared to using radio signals to follow the markers.~   "
86503|NCT02434796|"~     Women in Tanzania suffer alarming rates of intimate partner violence (IPV) that has~     detrimental effects on mental and physical health including an increased risk of HIV~     infection. The investigators will use a cluster randomized control study design to conduct a~     preliminary evaluation study of TEVAW, an intervention that aims to improve gender equitable~     attitudes and to decrease tolerance of IPV among men and women in rural Tanzania. Nine~     villages will be randomly assigned into one of three study arms, each comprised of 150~     partnered women and their co-resident male partners. Women in the comparison arm are~     currently exposed to World Education's savings and lending group intervention (known as~     LIMCA), in which they receive training on business skills, literacy, child nutrition and~     health, child protection, intimate partner violence (IPV) and HIV prevention. Women in~     Intervention Arm 1 will be exposed to LIMCA, while their male partners will participate in~     male peer group workshops that explore gender norms, IPV and HIV prevention issues. In~     Intervention Arm 2, men and women will receive the same treatment as Intervention Arm 1 and~     participate in community dialogues with community leaders to explore similar topics as the~     male peer groups. Our hypothesis is that study participants in Arm 2 will report improved~     gender equitable attitudes and lower intolerance of intimate partner violence than~     participants in Arm 1 and participants in the control group. Data will be collected at~     baseline and endline using a structured questionnaire with questions from three validated~     instruments that measure gender equitable attitudes and attitudes about IPV.~   "
86506|NCT02434757|"~     This small study is to investigate the efficacy and safety of Acthar as an adjunct therapy in~     patients with active rheumatoid arthritis (RA) who have had an inadequate response to disease~     modifying antirheumatic drugs (DMARDs) and at least 3 biologic agents. An in adequate~     response is defined as having ≥ 6 tender joints, ≥ 6 swollen joints, plus C-Reactive Protein~     (CRP) levels and/or erythrocyte sedimentation rate (ESR) of ≥ 1.2 times the upper limit of~     normal in spite of aggressive treatment, including ≥ 7.5 mg/d prednisone. This will be a 20~     week, prospective, multicenter, open-label study conducted at 3-4 university/medical centers~     and private practice settings in the US. A total of 20 eligible patients will be enrolled and~     other standard RA therapeutic agents, such as Methotrexate, DMARDs, non-steroidal~     anti-inflammatory drugs (NSAIDs), pain medications and others will not be discontinued. The~     primary endpoint will be the percentage of patients with reduction of ≥1.2 points of the~     Disease Activity Score in 28 joints (DAS-28) score.~   "
86507|NCT02434744|"~     This study will compare the safety, tolerability and efficacy of the combination of KD026 and~     metformin compared to placebo and metformin on improving glycemic control in patients with~     type 2 diabetes mellitus.~   "
86508|NCT02434731|"~     Needle procedures are the most common and important source of pain and distress in children~     in the health care setting. Children with intellectual disability from any cause experience~     pain more frequently than healthy children. They often require venipuncture or IV cannulation~     for diagnostic or therapeutic procedures. Pain in this population is often unrecognised~     because these patients are frequently unable to self-report their pain. Now it's possible to~     measure pain in children with intellectual disability with specific pain scales, like~     NCCPC-PV (Non-Communicating Children's Pain Checklist, Post-operative Version).~      The efficacy of a device combining vibration and cold for pain relief during venipuncture or~     IV cannulation has been recently reported in children. The device's actions are based on the~     Gate Control Theory, whereby cold and vibrations stimulate large fiber and inhibitory neurons~     to interrupt nociception. This non-pharmacologic technique for pain relief could be useful in~     this kind of patients in emergency department. To date, there is no study that validated~     Buzzy device for pain relief in children with intellectual disability.~      The aim of this study is to test the effectiveness of Buzzy® (a device that provides cold and~     vibration), in reducing the pain during venipuncture or IV cannulation, in children with~     intellectual disability.~   "
86509|NCT02434718|"~     The primary objective of the study is to evaluate the safety and tolerability of single and~     multiple intravenous (IV) infusions of Aducanumab in Japanese participants with mild to~     moderate Alzheimer's Disease (AD). The secondary objectives of this study are as follows: To~     evaluate the serum pharmacokinetics (PK) of Aducanumab after single and multiple intravenous~     (IV) infusions of Aducanumab; To evaluate the effect of single and multiple IV infusions of~     Aducanumab on immunogenicity.~   "
86510|NCT02434705|"~     The relationship or effect of food antigen (wheat based soy sauce) in eosinophilic~     esophagitis. It is believed that when food antigens are exposed to the esophageal tissue it~     starts an chronic allergy-based inflammation. This will be analyzed with the esophageal~     biopsies and the mucosal impedance probe.~   "
86511|NCT02434692|"~     The purpose of this study is to evaluate the safety and performance of the ARGOS-IO system in~     patients with POAG and indicated cataract surgery.~   "
86512|NCT02434679|"~     Antibiotic resistance is a major public health issue as multiresistant bacteria (MRB) are~     increasing. Among the actions to control resistance, one is an interesting lead: to prevent~     the emergence of resistant bacteria by limiting possibilities for bacteria to acquire~     resistance. Mechanisms of resistance genes acquisition are deeply studied but there are few~     data on the dynamic of acquisition over time. Among the genetic components that disseminate~     resistance genes, resistance integrons (RI) play a major role in the acquisition and~     dissemination of antibiotic resistance in gram-negative bacteria. The digestive tract of the~     newborn (NB), which is initially sterile, is colonized by a bacterial microbiota during the~     first days of life. It thus appears to be an appropriate model to study the dynamic of~     resistance acquisition. This project intends to follow the NB of neonatology over time in~     order to study the dynamic of the digestive acquisition of RI and MRB~   "
86513|NCT02434666|"~     This is a long-term-safety roll-over extension study for a Phase II Study (Protocol~     CPC-001-07).~   "
86514|NCT02434653|"~     Anemia diagnosis by hemoglobin level monitoring in women after vaginal delivery by symptoms~     versus screening of women at increased risk for post-partum anemia.~   "
86515|NCT02434640|"~     The objective of this trial is to investigate the safety and tolerability of BAY1128688 and~     to determine the concentration of this substance in blood after repeated administration by~     the oral route. The investigational substance will be administered in tablet form to healthy~     women.~   "
86516|NCT02434627|"~     The investigators' previous work in males with Becker Muscular Dystrophy shows that~     functional sympatholysis is restored by acute inorganic nitrate supplementation. This was~     translated from work using the mdx mouse model of dystrophinopathy. Recent work has shown~     that there is a frank improvement in grip strength when mdx mice are treated with an~     inorganic Nitric Oxide (NO) donor. The purpose of this study is to determine if chronic~     treatment with an inorganic NO donor can benefit patients with muscular dystrophy beyond~     blood flow regulation.~   "
86517|NCT02434614|"~     Several prospective randomized trials have demonstrated that concurrent chemoradiotherapy was~     superior to radiotherapy alone in the treatment of locoregionally advanced nasopharyngeal~     carcinoma (NPC). Based on these evidences, concurrent chemoradiotherapy (CCRT) with/without~     sequential chemotherapy has become the standard care for locoregionally advanced NPC.~     However, most of these evidences of standard treatment for locoregionally advanced NPC were~     based on the two-dimensional conventional radiotherapy (2DCRT). As the intensity-modulated~     radiation therapy (IMRT) technique has been widely used in the last decades, IMRT improved~     the treatment outcomes of patients with NPC, especially the local control rate. Currently,~     more retrospective studies compared the IMRT alone vs. IMRT plus concurrent chemotherapy, and~     reported that concurrent chemotherapy failed to improve survival rates for patients with~     locoregionally advanced disease, but increased the severity of acute toxicities. People~     started to reconsider the role of CCRT. Therefore, we propose this randomized phase III~     non-inferiority study to reassess the efficacy and contribution of concurrent chemotherapy in~     locoregionally advanced NPC during IMRT era.~   "
86518|NCT02434601|"~     The surface of non-carious cervical lesions (LCNC) is a challenge to adhesive systems, it~     presents a dentin layer sclera hypermineralized, presence of bacteria and lack of mechanical~     retention, so this study aimed to evaluate the influence of different surface treatments on~     LCNC through a randomized clinical trial. Patients with LCNC were referred to the study and~     selected according to the inclusion criteria, such as the presence of at least 3 LCNC. Three~     different types of surface treatment were carried out in LCNC: control group, 15 seconds of~     etching dentin; Group I, acid etching of dentin in 30 seconds; and group II, cavity~     prophylaxis with ultrasound for 30 seconds. The remaining steps of the adhesive and~     restorative procedure was the same for all groups, following the material manufacturer's~     recommendations. Evaluations of restorations will be carried out in periods of one week~     (baseline), six months, one year, two years and three years as of tooth sensitivity,~     integrity and color change. Data will be analyzed by McNemar and chi-square test.~   "
86519|NCT02434588|"~     During cataract surgery, it is necessary to dilate the iris in order to remove the~     crystalline lens and position the implant. The diameter of the optical implant being 6 mm, in~     case of capsulorhexis crystalline access 5.5 mm, the expansion should be at least 6 mm.~      At pre-operative consultation, the iris is always dilated by instillation of eye drops and~     measured at the slitlamp. For patients with an inadequate dilation, the intervention requires~     the use of a mechanical dilatation device.~      This study aims to assess the value of an alternative dilatation ring to Malyugin ring, which~     can be inserted and removed through an incision of less than 2 mm in diameter, due to its~     size smaller than that of the Malyugin ring.~      Our hypothesis is that this Bhattacharjee ring ensures sufficient and stable iris dilation~     during surgery, enabling implant placement in good conditions.~   "
86520|NCT02434575|"~     This registry study enables us to collect data on the treatment of LUTS using prostate artery~     embolisation (PAE), and other surgical methods to answer the following questions posed by~     NICE in 2013:~        -  Is PAE a safe and effective treatment option for LUTS caused by prostate enlargement?~        -  How does PAE compare with conventional surgical treatments? This will primarily be a~          surgical procedure called transurethral resection of the prostate (TURP) (see below).~        -  Which patients would most benefit from PAE over the other treatment options?~   "
86521|NCT02434562|"~     This is a prospective biobank set up to collect serum from patients with disorders associated~     with changes in androgens, estrogens or sex hormone-binding globulin (SHBG), before and/or~     after treatment.~   "
86522|NCT02434549|"~     The purpose of this double-blinded, placebo-controlled study is to test if treatment with~     Botulinum toxin-A is effective in reducing chronic muscle-related pain in adults with spastic~     cerebral palsy.~   "
86523|NCT02434536|"~     Objectives: To estimate the rate of appropriate hospital admissions , and of discharge to~     home episodes that would have been appropriate admissions to the hospital, on patients with~     exacerbations of their COPD by using appropriateness explicit criteria developed with the~     RAND appropriateness methodology. To evaluate the validity of those criteria by looking at~     their correlation with morbid-mortality, use of medications and health resources. To identify~     the variability in the appropriateness admission/discharge among the different centres~     participating on the study.~      Methodology: Prospective observational cohort study. 1. The investigators will apply the~     previously developed explicit criteria to a sample of COPD exacerbations presented in each of~     the Emergency Department of each participating hospital (16 centres). 2. The investigators~     will evaluate if there is variability among centres by comparing their appropriateness rates.~     3. To study the validity of the criteria, on those admitted the investigators will collect~     information on their evolution (length of stay, need of medication, quality of life),~     complications, vital status during their admission until discharge, and up to 2 months after~     the visit to the Emergency Department the vital status, complications, readmissions and~     quality of life. On those discharged to home from the Emergency Department, the investigators~     will check the presence of complications, vital status, readmissions and quality of life.~     People trained will collect all the needed information, in the Emergency Department, during~     their admission, or by personal interview to all discharged to home and to all at 2 months~     after the visit to the Emergency Department.~   "
86524|NCT02434523|"~     The study will compare the effectiveness of amitriptyline versus placebo (inactive~     medication) in treating chronic laryngitis.~   "
86525|NCT02434510|"~     The primary objective of this study is to compare the efficacy of adding 0.05% chlorhexidine~     gluconate to the splash basin in reducing bacterial growth from splash basins at the end of a~     total joint replacement procedure.~      Hypothesis: The 0.05% chlorhexidine gluconate solution will reduce the bacterial growth at~     the end of elective total joint arthroplasty cases.~      Null Hypothesis: There will be no difference in bacterial growth from the splash basin at the~     end of the case despite the addition of an antimicrobial solution.~   "
86526|NCT02434497|"~     The purpose of the study is to evaluate the safety of Rosuvastatin in Children and~     Adolescents with Homozygous Familial Hypercholesterolemia.~   "
86527|NCT02434484|"~     This is a PMS of Symbenda Injection (bendamustine hydrochloride) in Korean Patients. The main~     objective is to obtain safety information related to Symbenda treatment from clinical~     practice.~   "
86528|NCT02434471|"~     The purpose of this study is to evaluate a single breath hold abdominal MRI protocol and~     compare the image quality of respiratory triggered 3D T1-weighted images against conventional~     breath hold images.~   "
86529|NCT02434458|"~     The purpose of this study is to assess the diagnostic utility of Sudoscan in assessing small~     fiber nerve function, specifically those of the sudomotor, in patients with autoimmune~     disorders (i.e fibromyalgia and rheumatoid arthritis).~   "
86530|NCT02434445|"~     This study investigated the use of novel plasma and urinary biomarkers to predicte the~     development of hepatorenal syndrome in patients with advanced cirrhosis. The biomarkers~     investigated include plasma cystatin C, plasma NGAL, plasma NAG, plasma IL-18, plasma ADMA,~     plasma BTP, urinary KIM-1 and urinary LFABP. These biomarkers will be checked in advanced~     cirrhotic patients who have or have not developed hepatorenal syndrome and compared between~     the two groups. These biomarkers will also be correlated with the occurence of hepatorenal~     syndrome.~   "
86580|NCT02433795|"~     This study will be conducted to evaluate the efficacy of Bendamustine Plus Rituximab (BR) in~     patients with relapsed or progressive Marginal Zone B-cell Lymphoma (MZBCL).~   "
86531|NCT02434432|"~     Background: Music therapy has been recommended as an adjuvant therapy for both preterm~     infants and mothers throughout their stay in the Neonatal Intensive Care Unit (NICU), and has~     been shown to have some beneficial effects, although conclusive evidence remains lacking.~      Objectives: To study the usefulness of two forms of music, as well as no music, on pain and~     physiological and behavioral parameters of preterm infants during a heel stick procedure for~     obtaining blood in the Neonatal Intensive Care Unit (NICU).~      Hypotheses: Infants hearing music chosen by their mothers will have less pain and optimal~     behavioral and physiologic responses as compared to infants who hear the lullaby or no music.~      Methods: An analytical observational study with a randomized cross-over design will be~     utilized.~      Inclusion will be stable infants born between 28 to 36 weeks of gestation, with normal~     hearing. Neonatal Physiologic responses [heart rate (HR), oxygen saturation, (02 sat) and~     respiratory rate(RR)] and Behavioral States will be recorded before and after the heel stick~     procedure. Maternal age, education, and pregnancy complications will be also be documented.~     Pain responses will be recorded using the Neonatal Pain, Agitation and Sedation Scale~     (NPASS).~      Ethical considerations: The study imposes minimal risk on infants. One potential risk is that~     the infant may become agitated while listening to music, especially if it is time for~     feeding. Based on previous research, infants tend to calm down while listening to music.~     However, in the infants who may be hungry or fussy, music exacerbate their agitation. To~     prevent this from occurring the investigators will not perform the heel stick close to~     feeding time and the investigators will be vigilantly timing and monitoring the infant's~     agitation. Because music has been shown to calm infants and stop them from crying, the~     benefits outweigh this risk.~      The heel stick is performed routinely on infants (often 3-6 times a day). The investigators~     will not perform any additional heel sticks for this study, but will rather intervene during~     one of the scheduled heel stick procedures.~   "
86532|NCT02434419|"~     A prospective randomized clinical trial of patients undergoing bariatric surgery.~      Patients were randomly assigned into 3 groups: those patients undergoing percutaneous~     electrostimulation (PENS) of the pectoral muscle combined with specific training (Group 1),~     those patients doing the specific training alone (Group 2) and those patients without any~     specific treatment (Group 3).~      The assigned treatment began 15 days after surgery and was maintained during 12 weeks.~   "
86533|NCT02434406|"~     This study examines the feasibility and acceptability of a web-based intervention program for~     women with anxiety after childbirth, potential anxiety reduction after the intervention and~     determines the feasibility of the study design (randomized controlled design) and recruitment~     for the intervention in this population to inform the protocol (including effect size and~     study power) for a randomized controlled trial.~   "
86534|NCT02434393|"~     The purpose of this research study is to characterize the mechanisms contributing to~     cognitive impairment and accelerated cognitive decline in Late Life Depression (LLD).~      This is a non-randomized, observational, non-treatment study. One hundred and twenty (120)~     subjects who meet criteria for Major Depression or LLD will be enrolled for a period of 30~     months. Data from an additional 300 non-depressed subjects will be used from ADNI studies for~     comparison.~      Depression history, symptom severity and health information will be collected at the initial~     psychiatric visit to determine eligibility. A 3 Tesla (3T) Magnetic resonance imaging (MRI)~     scan and florbetapir (18F-AV-45) amyloid imaging will be conducted at the ADNI clinic site~     visits. Collection of plasma and serum for biomarkers, clinical assessments and cognitive~     assessments will be conducted at two time points. Blood samples will also be collected for~     genetic analysis.~   "
86535|NCT02434380|"~     The optimal vitamin D replacement dose during pregnancy remains undefined. Therefore, the aim~     of this study is to test the hypothesis that a daily equivalent dose of vitamin D of 3,000~     IU/day is needed for Middle Eastern women, to optimize maternal vitamin D level and neonatal~     musculoskeletal parameters, specifically knee-heel length at birth and bone mineral content~     at one month of age.~   "
86536|NCT02434367|"~     This multicenter randomized (1:1) phase 2 study is designed to assess the efficacy of the~     Walk with Ease exercise program on improving fatigue after adjuvant radiotherapy compared to~     usual care in 50 women with stage 0-3 breast cancer who have undergone breast surgery.~      Prior to initiation of radiation, during the last week, and 4-6 weeks post radiation, women~     in both arms will complete a number of surveys including questionnaires on fatigue, pain,~     depression, sleep, and social support. In addition, a blood sample will be collected prior~     to, during the last week of radiation, and 4-6 weeks post radiation to explore measures of~     inflammatory biomarkers, and their potential association with exercise and fatigue.~   "
86537|NCT02434354|"~     The main purpose of this trial is to evaluate the safety, tolerability and adverse event~     profile of pembrolizumab in subjects who have high risk melanoma before and after their~     standard of care surgical resection, and to collect tumor tissue from subjects before and~     after receipt of pembrolizumab to look at how the experimental drug interacts with tumor~     tissue. Subjects will receive 1 dose of neoadjuvant pembrolizumab, followed by complete~     resection and then a year of adjuvant pembrolizumab~   "
86538|NCT02434341|"~     15 patients with sepsis, 15 patients with COPD and 15 surgical patients will undergo~     polysomnographic sleep monitoring up to 24 hours in order to define if there are common sleep~     features within the groups~   "
86539|NCT02434328|"~     The purpose of this study is to compare RTH258 ophthalmic solution for intravitreal (IVT)~     injection to aflibercept solution for IVT injection in subjects with untreated active~     choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the~     study eye. This study will be conducted in the following countries: Austria, Belgium,~     Croatia, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Ireland, Italy,~     Malaysia, Netherlands, Norway, Poland, Portugal, Russia, Singapore, Slovakia, Sweden,~     Switzerland, Taiwan, Turkey, and the United Kingdom.~   "
86540|NCT02434315|"~     The purpose of this study is to evaluate the impact of varying amount of FreeStyle Libre Pro~     wear as measured by time in range.~   "
86541|NCT02434302|"~     This is a study to ascertain the number of children with moyamoya in the UK, their presenting~     features, clinical course and outcomes.~   "
86542|NCT02434289|"~     The purpose of this pilot study is to investigate the feasibility and potential impact of a~     combined resistance exercise and increased protein intake intervention in (frail) elderly, in~     a real-life setting.~   "
86543|NCT02434276|"~     This is a multi-center, randomized, double-blind, active comparator controlled study in which~     up to 450 healthy adults age 18-64 years will be administered either one of two dose levels~     of VAX2012Q or a licensed quadrivalent influenza vaccine. The subjects will be randomized at~     a 1:1:1 ratio.~   "
86544|NCT02434263|"~     The purpose of this study is the evaluation of the performance, safety and efficacy of Hydra~     Aortic valve in real-world patients. Following initial implantation, all patients will have~     clinical follow up at 30 days, 3, months, 6 months and 12 months~   "
86545|NCT02434250|"~     The aim of this study is to evaluate the efficacy of selective laser trabeculoplasty after a~     prior failed phacoemulsification and Eximer Laser Trabeculectomy.~   "
86550|NCT02434185|"~     The bilateral deficit phenomenon (BLD) is defined as an inability of the neuromuscular system~     to generate maximal force when two homonymous limb operate simultaneously (bilateral~     contraction) with respect to the force developed when both limbs acts separately (unilateral~     contraction). From an applied perspective, movement patterns of bilateral homonymous limb are~     often developed during activities of day living, e.g. rising from a chair or opening a jar.~     The BLD can be considered an intrinsic property of the human neuromuscular system but could~     be enough important to constitute a performance-limiting factor for postmenopausal women that~     involves a degenerative loss of muscular strength. Therefore, a specific analysis of this~     phenomenon and its relation with activities of daily living, such as climbing a step and~     rising from a chair, is crucial for detecting variables of neuromuscular performance and~     develop strategies to minimize the loss of strength.~   "
86551|NCT02434172|"~     The study will determine if the initiation of a 'screen and treat' program for cryptococcal~     disease among HIV positive individuals decreases morbidity and mortality among individuals~     with CD4 count < 100 cells/mm3. The study will screen individuals who are asymptomatic for CM~     and are either ART naïve or ART experienced with CD4 count < 100 cells/mm3.~      The introduction of an cheap, easy to use point of care diagnostic test the lateral flow~     assay will facilitate rapid diagnosis of cryptococcal disease in resource limited settings.~     The investigators will determine the efficacy of the lateral flow assay in identifying latent~     and asymptomatic cryptococcal disease. The investigators will determine the efficacy of the~     test in detecting disease in readily available body fluids such as urine and whole blood~     obtained via finger-stick method. The investigators will also determine the cost~     effectiveness of a screen and treat approach for cryptococcal disease in Zimbabwe.~      The investigators also wish to understand why some individuals with low CD4 counts reactivate~     cryptococcal disease and screen positive for cryptococcal antigen (CrAg) while others with~     similar levels of immunocompromised do not.~   "
86552|NCT02434159|"~     The purpose of this study is to determine if detailed scanning of the heart before~     biventricular device insertion will improve outcomes for heart failure patients.~   "
86553|NCT02434146|"~     This phase I/II trial studies the safety of topical phenylephrine solution and to see how~     well it works in preventing oral mucosa (mouth sores) in bone marrow transplant patients~     receiving cyclophosphamide and total body radiation therapy. Topical phenylephrine solution~     may prevent or lessen the severity of oral mucosa in patients receiving cyclophosphamide and~     total body radiation prior to undergoing a bone marrow transplant.~   "
86554|NCT02434133|"~     The investigators proposed study is the first of its kind. The investigators will measure~     measles, mumps, rubella, tetanus, diphtheria and pertussis antibodies in patients on the~     current IBD treatment modalities and compare the vaccine antibody concentrations and~     correlate them with time since immunization.~   "
86555|NCT02434120|"~     Orbital masses develop at the expense of the orbital structures lacrimal glands, oculomotor~     muscles, optic nerve, meningeal spaces, peripheral nerves, bone wall, orbital fat, lymphoid~     structures or vascular structures. These masses can be tumors, benign or malignant, or~     pseudotumor, mainly represented by specific or non-specific orbital inflammation.~      Pathology is of considerable importance for the diagnosis and the treatment of those masses.~     However, biopsy or surgical resection of the orbital masses is sometimes difficult and~     dangerous outside expert centers.~      The identification of a non-invasive technique for distinguishing tumors from pseudotumors,~     thus avoid in some cases a biopsy, would be a major contribution for the patients.~      For salivary glands, MRI allows to identify 4 different types of MRI characteristics, one~     (type C) being related to malignant tumors.~      In this study, the investigators will try to see if extrapolation of those data to orbiltal~     tumors is feasible.~   "
86556|NCT02434107|"~     Sentinel lymph node biopsy (SLNB) is considered as standard diagnostic procedure in melanoma~     patients carrying a reasonable risk for metastases. In numerous studies the prognostic role~     of micro metastases in the sentinel node (SN) was described. However, the prognostic value of~     a complete lymph node dissection in patients with a positive SN is still unclear.~      This study was planned to analyse the survival outcome of patients with a positive SN~     receiving complete lymphadenectomy versus watchful waiting.~   "
86557|NCT02434094|"~     An e-learning training program is to prepare people with diabetes and their physicians on the~     use of UVA's Artificial Pancreas prototype -- Diabetes Assistant (DiAs).~   "
86558|NCT02434081|"~     The aim of the study is to investigate the tolerability (how severe the side effects are) and~     the efficacy (how well the treatment works) when nivolumab is added to the current standard~     treatment (chemotherapy and radiotherapy) given to patients with advanced NSCLC.~   "
86559|NCT02434068|"~     Residual fragments of urinary calculi after flexible ureteroscopy (URF) can cause symptoms~     and additional surgeries. The assessment of residual fragments by imaging is not~     standardized. Computed tomography (CT) is the best way for evaluation of urinary stones,~     however, ionizing radiation from CT is deleterious. The aim of this study is to define which~     patients may avoid CT for evaluation of residual fragments after URF. 115 patients with > 18~     years old undergoing URF for kidney stone < 20 mm or < 15 mm in the lower calyx diagnosed by~     CT will be studied. The clinical evaluation of patients will be held by the same urologist in~     pre-operative consultation, 7 days after the procedure, 30 days after the procedure and 100~     days after the procedure. The assessment of residual fragments will be made through TC,~     ultrasound and Kidney-bladder-ureter KUB 90 days after the procedure. The image methods for~     residual fragments assessment will be compared by Cochran Test and prediction of parameters~     to avoid CT will be made by multiple logistic regression, using IPSS 16.0, with significant~     level of 5%.~   "
86560|NCT02434055|"~     Purpose: To evaluate the accuracy of the AVERT PLUS to monitor contrast volume used during~     angiographic procedures.~      Research Design: The AVERT PLUS is an FDA 510K cleared device which consists of a contrast~     delivery modulator designed to reduce unnecessary contrast dye delivery to the patient during~     angiography (coronary or peripheral) and a concomitant system to precisely measure contrast~     volume delivered to the patient. This will be a first in man prospective observational study~     of the accuracy of this system to quantify contract volume used during clinically indicated~     angiography in the cardiac catheterization laboratory.~   "
86561|NCT02434042|"~     This project aims to study the benefits of probiotics namely Bifidobacterium longum BB536 in~     prevention of acute diarrhea and/or respiratory-related illnesses, which are found common~     among children in Malaysia aged from 2 to 6 years.~   "
86563|NCT02434016|"~     Background: Mechanical ventilation is a life saving intervention in patients with acute~     respiratory failure, for instance, due to infection or trauma. The main goals of mechanical~     ventilation are to improve oxygenation and decrease the load imposed on the respiratory~     muscles. Unfortunately, mechanical ventilation comes with adverse events including disuse~     atrophy and weakness of the respiratory muscles. The diaphragm is the main muscle for~     inspiration and therefore this clinical entity is commonly referred to as ventilator-induced~     diaphragm dysfunction (VIDD). Several studies have shown that inspiratory muscle weakness is~     associated with adverse outcomes, including prolonged duration of mechanical ventilation.~     Inactivity or disuse is a recognized risk factor for the development of VIDD: disuse may~     result from excessive unloading of the diaphragm by the ventilator. Therefore, clinicians aim~     to limit the risk of VIDD by using ventilator modes that allow patients to perform at least~     part of the total work of breathing when deemed clinically appropriate. However, even when~     these so-called assisted modes for ventilation are used, excessive unloading of the diaphragm~     may occur; without using technology that allows monitoring of diaphragm function, the~     clinician is often uncertain as to whether this muscle is indeed actively working. Continuous~     recording of the electrical activity of the diaphragm (EAdi) is used to monitor diaphragm~     muscle activity in ICU patients. Furthermore, sonographic measurements of diaphragm thickness~     allows for an easy quantification of diaphragmatic activity (thickening fraction) as well as~     providing a potentially useful mechanism for studying diaphragm injury and function during~     mechanical ventilation.~      Aim: To assess the duration of diaphragm muscle inactivity in patients admitted to the ICU~     using EAdi monitoring and to assess the correlation between diaphragm thicknening fraction,~     as measured by ultrasound, and electrical activity, as measured by EAdi.~      Hypothesis: Diaphragm muscle inactivity frequently occurs in the early phase of ICU admission~     Design: Observational pilot study in ventilated adult ICU patients admitted to the ICU at St~     Michael's Hospital. The investigators aim to enroll 75 patients.~      Primary outcome: Time from catheter positioning to first EAdi (> 5 uV last at least 5~     minutes)~   "
86564|NCT02434003|"~     Scoliosis is a three-dimensional deformity affecting the orientation and position of the~     spine. Locally, the shape of the vertebra is also affected. The most common form is~     adolescent idiopathic scoliosis (AIS) with a prevalence of 1-3% affecting primarily young~     adolescent females. AIS can either be treated using a brace and in some cases necessitate~     surgical correction to prevent progressive deformity. Risk factors for progression include~     female gender, curve magnitude and location, skeletal maturity and growth velocity. However,~     these risk factors have been shown to be inconsistent in predicting curve progression. Over~     the past 6 years, the investigators have developed a predictive model of the final Cobb angle~     in AIS based on 3D spinal parameters. This analysis was based on a prospective cohort of 195~     patients that were enrolled upon their initial visit and followed until maturity. This~     predictive model has a determination coefficient of 0.702. The proposed new study aims at~     refining and testing the external validity of this model in a larger cohort. The next step~     towards using the new model in the clinical setting is to redesign the model and to~     externally validate the model by measuring the agreement between the new method and the~     traditional Cobb angle at maturity in a larger multicenter study. The objective of this study~     is to characterize the risk of scoliosis progression based on local three-dimensional~     vertebral and pelvic measurements present on initial evaluation. Three-dimensional~     reconstructions will be derived from stereo-radiographs acquired with a new biplanar low-dose~     radiographic system installed in all 8 clinical sites (EOS system, EOS-Imaging, Paris). These~     calibrated radiographs will then be used to reconstruct the vertebrae and intervertebral~     disks at each level as well as the geometry of the pelvis. A series of local and regional~     parameters will then be calculated from these 3D reconstructions. Correlation analysis will~     help determine if intervertebral disk wedging, vertebral wedging, transverse plane rotation~     or pelvic geometry can be used as early predictors of curve progression in AIS.~      Identifying a new 3D measure of scoliosis associated with rapid curve progression could help~     predict which curves need early treatment to prevent further progression. The ultimate goal~     of this research project will be to validate this new predictive model and finally transfer~     this new predictive tool in the hands of clinicians treating AIS.~   "
86565|NCT02433990|"~     This research study is to determine the risk factors for acquired heart disease, in adults~     with congenital heart disease. This knowledge is important to develop and target ways to~     prevent or delay the onset of acquired heart disease in adults with congenital heart disease.~   "
86566|NCT02433977|"~     This study will examine the hypothesis that in obese asthmatics; treatment with NOx + CLA is~     well tolerated, safe and will increase eNO while reducing airway oxidative stress. Allied~     with this, the investigators will define whether supplementing with this bioactive mediator~     modifies the airway microbiome, and reduces airway inflammation.~   "
86567|NCT02433964|"~     The purpose of this study is to evaluate the therapeutic effects of the LED (627 +/- 10 nm)~     with respect to the localized pain and local swelling of ankle sprains in the initial phase.~   "
86568|NCT02433951|"~     In this study, up to 20 healthy individuals, 20 endo-ACAB patients, and 20 CABG patients~     undergo a maximal cardiopulmonary exercise test after hospital discharge (for patients only).~     Exercise tolerance is compared between groups.~   "
86569|NCT02433938|"~     Aim of the study is to evaluate the role of postoperative tibial nerve stimulation in the~     enhancement of the recovery of bowel function and in shortening the hospital stay.~   "
86570|NCT02433925|"~     Inflammation and oxidative stress are common findings in patients with Chronic Kidney Disease~     (CKD) undergoing conservative treatment, in addition to being associated with atherosclerotic~     process, are related also to the progression of CKD. In this regard, resveratrol, a phenolic~     compound with recognized antioxidant and anti-inflammatory properties, can play an important~     role in the control of metabolic disorders associated with CKD, since it can modulate the~     mechanisms involved in inflammation and oxidative stress cycle. Resveratrol is capable of~     promoting the activation of the transcription-related factor-2 nuclear factor erythroid~     factor 2 (Nrf2) , a nuclear factor with anti-inflammatory properties, and SIRT-1, a protein~     also associated with the reduction of inflammation. These two factors, in their turn, are~     able to inhibit / antagonize the activity of the nuclear factor κB (NF-kB), a transcription~     factor that participates in the inflammatory response. Although it is a promising treatment,~     there are no studies evaluating the effects of resveratrol supplementation in patients with~     CKD. Thus, this study aims to evaluate the effects of resveratrol supplementation on~     inflammation and oxidative stress in patients undergoing conservative treatment of CKD.~   "
86571|NCT02433912|"~     BACKGROUND: Several procedures have been reported for the surgical correction of gingival~     recession (GR), including the laterally positioned flap (LPF) and the coronally advanced flap~     (CAF), performed as single or two-stage procedures without or with, respectively, the~     preceding placement and healing of a free gingival graft (FGG). The objective of the present~     report was to compare the efficacy of single-stage LPF and CAF techniques in the treatment of~     localized maxillary GR defects.~      METHODS: Thirty-six patients with Miller class I GR defects were randomly assigned to be~     treated by either a CAF (n=18) or LPF (n=18). Clinical parameters, including recession height~     (RECH), the width of keratinized tissue (WKT), probing depth (PD) and vertical clinical~     attachment level (VAL) were assessed at the mid-buccal site. Visual plaque score (VPS) and~     bleeding on probing (BOP) were also assessed dichotomously. Clinical recordings were~     performed at baseline, 6 months and 5 years later. Inter-measurements differences were~     analyzed with a Chi-square or a Wilcoxon test, with significance set at α<0.05.~   "
86599|NCT02433548|"~     Femoral neck fracture is very common in the elderly and can produce severe to moderate pain.~     As this pathology is not life-threatening, waiting time in the emergency department may be~     prolonged due to the high number of unforeseen cases with patients remaining in pain.~      Fascia iliaca block consists of injecting local anaesthetics below the fascia iliaca,~     resulting in the anaesthesia of the femoral, the lateral cutaneous and the obturator nerves,~     with effective analgesia.~   "
86572|NCT02433899|"~     BACKGROUND: The semilunar coronally repositioned flap (SLCRF) has been used for the treatment~     of recession defects (GR). Recently a microsusgical (MICRO) has been successfully employed~     with the procedure apparently resulting in improved results, however, no previous controlled~     clinical study has evaluated the MICRO SLCRF in comparison with SLCRF performed as originally~     described (MACRO). The objective of the present study was to compare the clinical outcomes of~     the MICRO and MACRO SLCRF in the treatment of human GR.~      METHODS: Fourteen patients, with bilateral Miller class I GR defects were randomly assigned~     to MICRO or MACRO SLCRF. Clinical parameters, assessed at baseline and 6 months later,~     included recession height (RECH), recession width (RECW), width of keratinized tissue (WKT),~     probing depth (PD), clinical attachment level (CAL), pain measurements and esthetic~     evaluation with the Root Coverage Score (RCS). Inter-measurements differences were analyzed~     with a Chi-square or a paired t-test, with significance set at α<0.05.~   "
86573|NCT02433886|"~     Up to 40% of Obsessive-Compulsive Disorder (OCD) patients do not respond to conventional~     treatments (medications or behavior therapy). For some of them, a neurosurgical treatment can~     be indicated. A previous study, employing bilateral double-shot ventral capsular/ventral~     striatal (VC/VS) Gamma capsulotomy (GVC) for OCD has shown that this radiosurgical technique~     is potentially efficacious and relatively safe. However, a few patients may develop~     complications associated to radionecrosis (eg., brain cysts) in a long-term follow-up, which~     are probably associated to lesion volumes. Another study, with the preliminary results of~     smaller VC/VS Gamma capsulotomy lesions has suggested that this procedure is safe and remains~     efficacious. Our aim is to investigate the efficacy and safety profiles of smaller,~     single-shot VC/VS Gamma capsulotomy for OCD. This study will support the development of a~     future double-blind, randomized clinical trial of single-shot VC/VS Gamma capsulotomy.~   "
86574|NCT02433873|"~     The primary purpose of this study is to evaluate the effect of an IMO nutritional supplement~     on gut microbiome, gut health, and body weight. Two formulations of the supplement will be~     evaluated; thus, there will be three study arms: Supplement A, Supplement B, and placebo.~     Stool samples will be analyzed for bacterial DNA. The gut bacterial DNA, body weight, and gut~     health data will be compared across supplement and placebo groups.~      Primary Aim 1: To evaluate the effect of the IMO supplement on gut bacterial abundance,~     diversity, and gene function across intervention and placebo groups, and across two doses of~     the intervention.~      Secondary Aim 1: To evaluate the effect of the IMO supplement on gut health across~     intervention and placebo groups, and across two doses of the intervention.~      Secondary Aim 2: To evaluate the effect of the IMO supplement on body weight across~     intervention and placebo groups, and across two doses of the intervention.~      60 subjects, randomized to three arms (20 each: Supplement formula A, Supplement formula B or~     placebo) will take a daily dose of Supplement A, Supplement B, or placebo for 8 weeks. The~     supplement is a light syrup liquid. Ingredients that are in the supplement are:~     isomalto-oligosaccharide, water, mannitol, maltose, glucose, and glycerol. Ingredients that~     are in the placebo are: high maltose corn syrup (Satin Sweet™), water, and mannitol. Dose~     will be 500 mg during the first 4 weeks and then 1000 mg for second 4 weeks. Subjects will be~     instructed to take 500 mg/day of the supplement or placebo the first four weeks and 1000~     mg/day of the supplement or placebo for the second four weeks. Subjects will be blinded as to~     whether they are receiving placebo or supplement. After screening and once enrolled, subject~     involvement includes visits to George Mason University, being weighed, dropping off stool~     samples, and completing a survey on gut health. Stool samples will be analyzed for bacterial~     DNA. The gut bacterial DNA, weight, and gut health data will be compared across supplement~     and placebo groups.~   "
86575|NCT02433860|"~     There is a significant need for nicotine cessation programs for pregnant women in Spokane~     County. SCRIPT has been proven to be an effective method for smoking cessation in pregnant~     women. This study will evaluate the success of SCRIPT delivered by pharmacists. At the end of~     the study, the investigators hope to have three questions answered: 1) what is the quit rate~     of pregnant women in the Spokane area who receive the SCRIPT intervention delivered by~     pharmacists? 2) How does the quit rate compare to the quit rates of SCRIPT programs delivered~     by other health care providers as documented in the literature? And 3) Does the SCRIPT~     intervention have a significant effect on quit rates for pregnant women compared to current~     Spokane county quit rates? Urine cotinine tests will be used to document smoking status~     before delivery of the SCRIPT program, approximately one week after quit date and at >36 wks~     gestation or at delivery for study participants.~   "
86576|NCT02433847|"~     Effect of mosapride 30mg/day on the small bowel and colon transit time in patients with~     chronic constipation or constipated irritable bowel syndrome.~   "
86577|NCT02433834|"~     A Randomized, Double-Blind, Chronic Dosing (14 days), 5-Period, 7-Treatment,~     Placebo-Controlled, Incomplete Block, Cross-Over, Multi-center, Dose-ranging Study to Assess~     the Efficacy and Safety of Glycopyrronium MDI (PT001) Relative to Placebo MDI and Open-Label~     Serevent Diskus in Adult Subjects With Intermittent Asthma or Mild to Moderate Persistent~     Asthma~   "
86578|NCT02433821|"~     The neck pain comes from disturbances related to the cervical spine, of multifactorial origin~     and is considered a frequent problem of disability.~      Pilates is a physical conditioning method that has been widely used to improve posture and~     develop body awareness.~      The aim of this study is to assess the impact of the Pilates method in the control of pain,~     function and quality of life in patients with chronic mechanical neck pain.~      Methods: 64 patients with chronic mechanical neck pain will be selected and randomized into~     two groups: intervention and control. Both groups will be assessed for pain, function,~     quality of life and medication intake.~      The intervention group will hold Pilates sessions for three months, with two sessions per~     week. The control group will continue with the usual drug treatment. Both groups will be~     instructed to use 750mg acetaminophen every 6 hours if there is pain, but consumption of the~     drug will be controlled.~      Although the symptoms of neck pain are common in the population, no study has investigated~     the effects of the Pilates method as a possible treatment for neck pain. The hypothesis is~     that the Pilates method can offer benefits to these patients.~   "
86579|NCT02433808|"~     Patients undergoing surgery often receive paralytic agents (or neuromuscular blocking agents~     (NMBAs)) to facilitate the procedure. At the end of surgery, the effects NMBAs are reversed~     with a drug called neostigmine. The use of neostigmine significantly reduces the risk that a~     patient will be left with muscle weakness in the recovery room. Many anesthesiologists~     routinely use neostigmine because postoperative muscle weakness may lead to adverse events~     after surgery. Other anesthesiologists do not routinely administer neostigmine in the~     operating room because of concerns about potential side effects. Surprisingly, some~     investigators have reported that neostigmine-induced muscle weakness may occur if the drug is~     given when the effects of the NMBAs have completely worn off. In contrast, other~     investigators have not observed this side effect when neostigmine was given at the end of~     surgery. The aim of this study is to determine whether neostigmine use is associated with~     muscle weakness when it is given at the time of nearly complete recovery from NMBAs. Muscle~     strength will be measured using a sensitive monitor (TOF-Watch-SX) and through an examination~     of the patient for evidence of muscle weakness. Patients will also be evaluated how they~     recover from anesthesia and surgery.~   "
86581|NCT02433782|"~     Designing a treatment protocol using myofascial therapy for the treatment of pain and~     restrictions on mobility in patients with hemophilic arthropathy of the knee and ankle.~      Pilot with a small number of patients for assessment the effectiveness and safety of the~     treatment protocol created.~      Randomized clinical trial to assess the effectiveness of treatment with myofascial therapy in~     patients with hemophilia.~      Describe the differences in terms of the dependent variables (range of motion, pain and~     flexibility) in patients with hemophilia who have carried out the treatment.~      Report the relationship between the clinical characteristics of patients and the results~     obtained after the treatment period.~   "
86582|NCT02433769|"~     Muscle relaxants are administered to most patients undergoing general anesthesia in order to~     facilitate the placement of an endotracheal tube and improve operating conditions. Despite~     routine reversal of these agents, many patients arrive in the recovery room with evidence of~     residual muscle weakness. Many studies have demonstrated that residual neuromuscular blockade~     (weakness) is a common occurrence after surgery. The only method of reliably detecting the~     presence of perioperative neuromuscular blockade is through the use of quantitative~     neuromuscular monitors. These devices measure and quantify the degree of muscle weakness and~     display the results on a screen. When using train-of-four (TOF) nerve stimulation, the ratio~     of the fourth muscle contraction (twitch) to the first twitch will be displayed; when this~     ratio is 90% (or 0.9) or greater, full recovery of muscle strength is present, and the~     endotracheal tube can be safely removed. At the present time, there is only one~     commercially-available stand-alone quantitative monitor available in the United States -the~     TOF-Watch (an acceleromyography device). It is not used by many clinicians because it~     requires experience to obtain accurate results, is expensive, and is subject to interference~     by factors in the operating room. The aim of this investigation is to examine a new~     quantitative monitor, the TOFscan (a new three dimensional acceleromyography device). In~     order to study the accuracy of this new device, the TOFscan will be compared to the current~     clinical gold standard, the TOF-Watch-SX.~   "
86583|NCT02433756|"~     The purpose of this study is to observe the evolution of the CRTD system with left~     quadripolar lead, in terms of electrical parameters in all pacing configurations and to~     evaluate the impact on the clinical outcome.~   "
86584|NCT02433743|"~     A clinical trial was conducted in 65 PLWH randomly allocated to receive standard hospital~     diet alone (Control group: n=33), or the diet combined with 100 g/day of RUTF (RUTF group:~     n=32). Individual dietary intakes were measured and compared to the Recommended Dietary~     Allowances (RDA) for PLWH. Body composition was measured by bio-impedance analysis (BIA),~     hemoglobin by HemoCue and plasma zinc concentration by atomic absorption spectrometry and~     adjusted to infection (CRP and α1-AGP). All measures were conducted at baseline, 3 weeks and~     after 9 weeks home-based follow up.~   "
86585|NCT02433730|"~     The purpose of this study is to evaluate the efficacy of testosterone replacement therapy in~     men with low testosterone due to opioid treatment on body composition, the haemostatic~     system, glucose metabolism, muscle function, pain sensitivity, pain modulation, lipids,~     sexual function and quality of life.~      Male patients on opioids for non-malignant diseases aged 18-59 years diagnosed with~     hypogonadotrophic hypogonadism, referred from day hospitals and outpatient populations. 40~     patients are randomized to either testosterone undecanoate i.m. or placebo i.m., i.e. 20~     patients per arm~      A double blinded randomized placebo controlled trial~   "
86586|NCT02433717|"~     Background Paliperidone is an active metabolite of risperidone, both of which are~     antipsychotic agents for treatment of schizophrenia and related psychotic disorders.~     Pharmacogenetic studies have revealed that the efficacy and side effects of antipsychotic~     agents are related to polymorphisms of specific genes, however, there are just a few related~     studies on paliperidone. The current study aims to evaluate whether pharmacogenetic markers~     related to risperidone and genetic markers associated with schizophrenia have effects on the~     clinical effectiveness of paliperidone treatment. The study also uses changes of~     event-related potentials (ERP) as indices for clinical efficacy.~      Methods It is a prospective, open-label, non-randomized and uncontrolled clinical trial to~     study the efficacy and side effects of 6-week paliperidone ER treatment for patients with~     schizophrenia or schizoaffective disorder. The first three weeks of treatment has to be~     inpatient treatment. In the first two weeks, participants will take 9 mg paliperidone ER~     daily. Then the dose of paliperidone can be adjusted to within the range of 6-12 mg per day.~     Efficacy indicators include symptom severity, global functioning, and ERP. Side effect~     indicators include common side effect evaluate, extrapyramidal symptoms, metabolic profiles,~     hormonal change, and bone metabolism indices. Participants will also receive examinations for~     blood drug concentration, genetic polymorphisms, and epigenetic markers.~   "
86587|NCT02433704|"~     To directly compare acute infection rates in patients undergoing total knee replacement with~     intraosseous regional administration or systemic intravenous administration of prophylactic~     antibiotics.~   "
86588|NCT02433691|"~     This pilot study is a first step in a rapidly growing area of clinical research to create the~     most effective means to combat age-related losses in cognitive function through preventive~     lifestyle strategies such as physical exercise and memory training. This study will develop~     innovative simultaneous exercise and memory training programs in non-demented volunteers with~     subjective memory complaints (controls or MCI). Our primary goal is to assess the cognitive~     impact of 4-week memory training programs done twice weekly: 1. during simultaneous aerobic~     exercise (SIM-AR-MET), 2. sequentially after aerobic exercise (SEQ-AR-MET), or 3. without~     aerobic exercise (replaced with sequential stretching and toning) (SEQ-ST-MET). The~     investigators will also measure potential metabolic (e.g., glucose, lipid panel) and~     molecular (serum BDNF) mediators of observed cognitive changes in a subset of participants~     (those at the UCLA CTRC/IPCN site).~   "
86589|NCT02433678|"~     This is a single center, prospective, randomized, placebo -controlled, parallel design and~     double blind study to evaluate oxidative stress, inflammation and hypertension markers and~     mediators before and after treatment with dapagliflozin.~   "
86613|NCT02433366|"~     The key focus of this survey will be to collect data on physicians awareness of the content~     of the Pradaxa® Prescriber Guide and the extent to which risk awareness is communicated to~     patients. The data collected with atrial fibrillation patients will show if and how well this~     information is received and understood.~   "
86590|NCT02433665|"~     1. To determine if a formula derived from PCA using specific patient parameters can be used~          to determine the individual contrast material dose and provide a more consistent level~          of vascular and parenchymal enhancement during MDCT scanning of the abdomen and pelvis.~        2. Up to 500 adult patients referred for a CT of the abdomen and pelvis with contrast~          material will be recruited to participate in this trial. Single CT axial slices (n=2)~          will be obtained at the level of the L4 pedicle and the supra-acetabular pelvis using a~          field-of-view that includes all of the patient. From patient measurements (height,~          weight, body dimensions), a customized dose of contrast material will be specified~          according to the derived formula for 400 subjects. One hundred subjects will receive the~          usual fixed contrast dose.~        3. Enhancement data in HU will be measured from the CT scans using manually-placed ROIs on~          the upper abdominal aorta, main portal vein and liver parenchyma, avoiding visible liver~          tumors, major blood vessels and artifacts, if present. This enhancement data will be~          used to determine the patient-to-patient variability.~   "
86591|NCT02433652|"~     Infection with dengue viruses is the leading cause of hospitalization and death in children~     in many tropical Asian countries, and the development of a dengue vaccine is a top health~     priority. This study will evaluate the ability of a single dose of a trivalent dengue vaccine~     to protect against infection with an attenuated candidate DENV-2 vaccine, administered 6~     months after the trivalent dengue vaccine.~   "
86592|NCT02433639|"~     Biliary tract cancer is relatively rare cancer, with generally poor prognosis. In~     metastatic/recurrent biliary tract cancer, the most commonly used 1st-line chemotherapy is~     gemcitabine+cisplatin combination. However, there is no standard 2nd-line chemotherapy and~     there is no validated targeted therapeutic agent, even though this tumor harbors diverse~     genetic characteristics.~      TH-302 (1-methyl-2-nitro-1H-imidazole-5-yl)methyl N,N'-bis(2-bromoethyl) diamidophos-phate is~     a nitroimidazole-linked prodrug of a brominated version of isophosphoramide mustard (Br-IPM).~     When exposed to hypoxic conditions, TH-302 is reduced at the nitroimadazole site of the~     prodrug by intracellular reductases leading to the release of Br-IPM. Br-IPM can then act as~     a DNA crosslinking agent. In areas of normoxia, TH-302 remains intact as a prodrug and~     toxicity is minimized. In addition, preclinical data suggest that after activation, the~     active moiety may diffuse to areas outside the hypoxic region, demonstrating a bystander~     effect and possibly exhibiting additional anti-tumor activity.~      It is well known that biliary tract cancer is hypovascular tumor, so it contains large~     hypoxic area in the tumor. Therefore it would be worthy to test TH-302 in biliary tract~     cancer.~      This study is a phase II study of TH-302 monotherapy as second-line treatment in advanced~     biliary tract cancer, to investigate efficacy and safety of TH-302 monotherapy.~   "
86593|NCT02433626|"~     Activity of COTI-2 has been demonstrated in various cancer tumor models. With its p53- and~     AKT-based mechanisms of action, COTI-2 is anticipated to be highly relevant in treatment of~     patients with gynecologic malignancies or head and neck suamous cell carcinoma (HNSCC).~      This study is designed primarily to assess the safety and tolerability of COTI-2 in patients~     with advanced and recurrent gynecologic malignancies and HNSCC to establish a recommended~     Phase 2 dose (RP2D) for future studies.~      Patients are currently being recruited for Part 2 of the study.~   "
86594|NCT02433613|"~     Prospective, multi-center, single-arm, non-interventional and open-label registry. The~     purpose of the registry is to document use of Phased Radio Frequency Ablation (hereafter~     Phased RFA) System in a real world patient population with atrial fibrillation and evaulate~     its performance.~      Gold AF will enroll a minimum of 1,000 patients who undergo Phased RFA in approximately 38~     sites in Western, Central Europe, Israel and South Korea.~   "
86595|NCT02433600|"~     This study is intended to measure declarative or stored memory and behavior between infants~     who consume one of two infant formulas through approximately one year of age.~   "
86596|NCT02433587|"~     The primary objective of the trial is to evaluate short versus long duration dual~     antiplatelet therapy in patients undergoing lower extremity endovascular revascularization.~   "
86597|NCT02433574|"~     Despite improved staging and operative techniques, the rate of incomplete resection (R1) of~     NSCLC has remained significant over the last decades. Patients with R1 resection have~     significantly worse survival compared to those with complete resection (R0).~      This is a phase I study that investigates the feasibility and safety of delivering~     Stereotactic Body Radiotherapy (SBRT) to patients with locally invasive NSCLC (cT3-4, N0-1)~     who are at risk for incomplete resection.~      Twenty patients with NSCLC will be treated with SBRT followed by surgery and appropriate~     adjuvant therapy. Patients will be divided into groups, of 5 patients each, treated with~     escalating doses (35, 40, 45 and 50 Gy) in 10 daily fractions.~      The primary outcome is the feasibility i.e. the ability to complete safely SBRT and surgery~     (within 6 weeks). Secondary outcomes include acute and late adverse events, R0/R1/R2 rates~     and secondary surrogates of feasibility.~      If successful, this study will lead to further evaluation of pre-operative SBRT in NSCLC.~   "
86598|NCT02433561|"~     Continuous interscalene brachial plexus block consists of inserting a catheter directly~     within the brachial plexus in the interscalene groove, between the middle and anterior~     scalene muscles, which is then infused with local anesthetic. This technique provides potent~     and site-specific analgesia for several days after major shoulder surgery, along with~     increased shoulder range of motion. A major side-effect of this procedure is the paralysis of~     the ipsilateral diaphragm, which is the main muscle of the respiration. This paralysis occurs~     at a rate of 90 to 100%, and is due to the spread of the local anesthetic towards the phrenic~     nerve, lying anteriorly to the plexus, between the sternocleidomastoid and anterior scalene~     muscles. Therefore, many patients suffering from respiratory syndromes, such as chronic~     obstructive pulmonary disease, will not have a continuous interscalene brachial plexus block,~     thus forfeiting some, or all, of the aforementioned benefits associated regional anesthesia.~      It is conventionally taught to place the needle tip between the nerve roots of the brachial~     plexus to obtain an effective block (intra-plexic injection). Recently, we have published a~     new technique of single-shot injection for interscalene brachial plexus block where the~     needle tip was positioned at a distance of 4 mm of the lateral part of the brachial plexus~     (extra-plexic injection) and resulted in a reduction rate of 70% of hemidiaphragmatic paresis~     and a preservation of spirometric values, while providing similar analgesia, when compared to~     a conventional injection. Contrary to single-shot injections where high volume and high~     concentration of local anesthetics are injected (eg, ropivacaine 0.5%, 20 mLs), continuous~     blocks required low volume and low concentration (eg, ropivacaine 0.1-2%, 2-6 mLs/h) and~     therefore the aforementioned concept of extra-plexic technique might not be suitable.~      Recently, new catheter-over-the needle (Contiplex® C; B. Braun Melsungen AG, Germany) have~     been released on the market and allows the physician to place the catheter tip exactly where~     he desires, contrary to the previous generations where the catheters were inserted blindly,~     despite the use of ultrasound.~      The first objective of that randomised controlled trial is to demonstrate that an~     extra-plexus catheter placement produces less respiratory complications than an intra-plexus~     catheter placement. The second objective is to confirm that both techniques provide similar~     analgesia.~   "
86600|NCT02433535|"~     This purpose of this clinical trial is to determine if a statin drug, Simvastatin, added to~     inhaled corticosteroids and bronchodilators can reduce systemic and airway inflammation,~     improve lung function and symptoms, and reduce acute exacerbations in patients with severe~     asthma who are already on controller inhaler therapy.~      This proposed investigator-initiated, single-center, early Phase II, cross-over, randomized~     clinical trial, titled Randomized Trial of Simvastatin for the Treatment of Severe Asthma,~     will be conducted at the University of California, Davis Medical Center (UCDMC) in~     Sacramento, CA. This trial will evaluate Simvastatin for treatment of asthma in subjects with~     severe asthma (as defined by the American Thoracic Society (ATS)), who are already taking~     inhaler controller therapy. The investigators plan to enroll 24 patients with severe allergic~     asthma.~      The investigators hypothesize that treatment with Simvastatin 40 mg (administered once daily)~     will not only improve indicators of airway and systemic allergic/Th2 inflammation, but will~     also reduce acute exacerbations and improve lung function. All patients will be on standard~     controller therapy including appropriate doses of inhaled corticosteroids and long-acting~     bronchodilators.~   "
86601|NCT02433522|"~     MAINRITSAN study compared Rituximab and azathioprine as maintenance therapy for~     ANCA-associated vasculitides. In this study, Rituximab (5 infusions at D1, D15, M6, M12, M18)~     was superior to azathioprine (2 mg/kg/day) to prevent relapses of AAV 28 months after the~     inclusion (Guillevin et al. NEJM 2014). Nevertheless, in the follow-up study of MAINRITSAN,~     up to 30% of patients experienced a relapse 38 months after the last rituximab infusion~     (unpublished data). Right now, no randomized controlled study has been carried in order to~     evaluate the best duration of the maintenance treatment with rituximab.~      The investigators objective is to evaluate the efficacy of a long term rituximab treatment to~     prevent relapses of ANCA-associated vasculitis in patients in remission after a first phase~     of rituximab maintenance treatment.~      The investigators will conduct a randomized placebo-controlled trial of a long term rituximab~     maintenance treatment (46 months) against a conventional maintenance treatment (18 months).~   "
86602|NCT02433509|"~     The objective of the study is to determine the safely of Human Umbilical Cord Blood~     mononuclear cells by Intravenous injection in acute ischemic stroke patients.~   "
86603|NCT02433496|"~     This project pilot tests an innovative clinical guideline translation and physician coaching~     model to promote adherence to evidence-based guidelines for the prescribing of opioid pain~     medications in primary care settings.~   "
86604|NCT02433483|"~     Allogeneic transplant can sometimes be an effective treatment for leukemia. In a traditional~     allogeneic transplant, patients receive very high doses of chemotherapy and/or radiation~     therapy, followed by an infusion of their donor's bone marrow or blood stem cells. The~     high-dose chemotherapy drugs and radiation are given to remove the leukemia cells in the~     body. The infusion of the donor's bone marrow or blood stem cells is given to replace the~     diseased bone marrow destroyed by the chemotherapy and/or radiation therapy. However, there~     are risks associated with allogeneic transplant. Many people have life-threatening or even~     fatal complications, like severe infections and a condition called graft-versus-host disease,~     which is caused when cells from the donor attack the normal tissue of the transplant patient.~      Recently, several hospitals around the world have been using a different type of allogeneic~     transplant called a microtransplant. In this type of transplant, the donor is usually a~     family member who is not an exact match. In a microtransplant, leukemia patients get lower~     doses of chemotherapy than are used in traditional allogeneic transplants. The chemotherapy~     is followed by an infusion of their donor's peripheral blood stem cells. The objective of the~     microtransplant is to suppress the bone marrow by giving just enough chemotherapy to allow~     the donor cells to temporarily engraft (implant), but only at very low levels. The hope is~     that the donor cells will cause the body to mount an immunologic attack against the leukemia,~     generating a response called the graft-versus-leukemia effect or graft-versus-cancer~     effect, without causing the potentially serious complication of graft-versus-host disease.~      With this research study, the investigators hope to find out whether or not~     microtransplantation will be a safe and effective treatment for children, adolescents and~     young adults with relapsed or refractory hematologic malignancies~   "
86605|NCT02433470|"~     In the study the investigators aim to test whether transcranial direct current stimulation~     (tDCS)-induced pain reduction is in association with functional changes in the brain measured~     with magnetic resonance imaging (MRI) in patients with chronic inflammatory bowel diseases~     (IBD).~      Hypothesis: Transcranial direct current stimulation can reduce the perception of pain in~     patients with chronic inflammatory bowel diseases, which is in association with changes in~     the brain measured via MRI.~   "
86606|NCT02433457|"~     To evaluate the PK profile of the newly developed CC-292 SDD formulation compared to CC-292~     P22 tablet.~   "
86607|NCT02433444|"~     In this study, the investigators aim to distinguish patients with Post-Endoscopic retrograde~     cholangiopancreatography (ERCP) Pancreatitis (PEP) vs. those without PEP based on difference~     in pre- vs. post-ERCP measurements of AGIS-derived intestinal rates (IR). Based on the~     clinical observation that many patients with PEP develop ileus following ERCP, the~     investigators hypothesize that patients who develop PEP will exhibit lower IR following ERCP,~     and therefore a larger difference in pre- vs. post-ERCP IR.~   "
86608|NCT02433431|"~     The purpose of this study is to test the active components of mindfulness meditation for~     reducing psychological stress and improving biomarkers of health. This study compares the~     effects of three brief trainings: (1) training in both present-moment attention and mindful~     acceptance, (2) training in present-focused attention, and (3) an active psychological~     training with no mindfulness content.~   "
86609|NCT02433418|"~     300 women with unexplained infertility will be randomly divided into 2 equal groups: Group 1~     will be offered tubal flushing with water soluble media through hysterosalpingography (HSG)~     and group 2 will receive no intervention~   "
86610|NCT02433405|"~     The purpose of this study was to evaluate acute phase proteins (APPs) Fetuin-A and Serum~     Amyloid A (SAA) levels in gingival crevicular fluid (GCF) and serum samples in periodontal~     health and disease.~   "
86611|NCT02433392|"~     The purpose of this trial is to determine the safety and feasibility of injecting irinotecan~     hydrochloride drug-eluting beads directly into the cavity remaining after a tumor is~     surgically removed in patients with a type of brain tumor (glioblastoma multiforme - also~     known as glioma) that has returned after prior therapy.~   "
86612|NCT02433379|"~     This study assesses the 18-month incidence of inappropriate shocks in subjects implanted with~     the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) for primary prevention of sudden~     cardiac death. Devices are to be programmed with zone cutoffs at 200 bpm and 250 bmp in order~     to mimic the programming settings for transvenous ICDs in the MADIT RIT study. The incidence~     of inappropriate S-ICD shocks will be compared to the incidence of inappropriate shocks~     observed in the MADIT RIT study.~   "
86654|NCT02432833|"~     The purpose of the study is to compare tacrolimus dosing of the new Envarsus®-based~     immunosuppressive regimen with current clinical practice (Prograf or Advagraf) over 6 months~     following de novo renal transplantation in a real-life setting in different European~     Countries.~   "
86614|NCT02433353|"~     Approximately 150 active duty service members meeting Diagnostic and Statistical Manual~     version 5 (DSM-5) criteria for posttraumatic stress disorder (PTSD) and scoring 50 or above~     on the Clinician Administered PTSD Score for DSM-5 (CAPS-5) will be recruited. Qualifying~     participants will be randomized on a 1:1 basis to either the eye movement desensitization~     reprocessing (EMDR) plus venlafaxine XR group or the EMDR plus placebo group. Protocol will~     call for participants to complete 12 one-hour EMDR session while taking a venlafaxine~     XR/placebo dose of 150mg or 225mg for the entire 24 weeks. Both prescribers and therapists~     will be blinded and CAPS-5 assessments will be completed by an individual not involved in a~     participant's direct treatment. An unblinded pharmacist will dispense medication or placebo~     according the instructions of the prescriber and will count remaining tablets to measure~     compliance. All EMDR sessions will be recorded and will be reviewed by the principal~     investigator using a fidelity checklist. CAPS-5 will be administered after completion of EMDR~     and again at 6 months from the date of his/her first therapy session.~   "
86615|NCT02433340|"~     This is a Phase 2, multicenter, 24-week OLE study to assess the safety and tolerability of~     ABT-122 in participants with rheumatoid arthritis (RA) who had had an inadequate response to~     methotrexate (MTX) therapy and who completed the preceding Study M12-963 randomized~     controlled trial, in which participants had been randomized to receive 1 of 3 doses of~     ABT-122 (60 mg every other week [EOW], 120 mg EOW, or 120 mg every week [EW]) or adalimumab~     40 mg EOW given on background methotrexate.~   "
86616|NCT02433327|"~     Critical illness in the patient and death can potentially be predicted and prevented.~     Deterioration of the clinical condition of hospitalised patients is often preceded by~     physiological changes up to 24 hours before death. Despite this several reports show that~     lack of identification and proper actions in patients developing acute and critical illness~     remains a problem.~      The purpose of this study is to investigate if Paediatric early Warning Score (PEWS)~     optimises identification of acute and critically ill children and prevents life-threatening~     situations. The hypothesis is that implementation of PEWS supported by directions for action~     algorithms for intervention will have an impact on number of unplanned transfers to intensive~     care in already hospitalised children.~      This study is a multi-centre randomised controlled intervention study designed within a~     Complex Intervention framework; the study sheds light on the problem, validation of the data~     collection instrument, testing of the intervention and evaluation. The study involves all~     paediatric departments and some acute departments in Central Denmark Region. The study is~     designed as a randomised controlled intervention study where children are randomised to one~     of two different Paediatric Early Waning Score models.~      Development and implementation of PEWS is expected to contribute to reduce the number of~     children developing acute critical illness, number of admissions to intensive care. PEWS is~     also expected to contribute to increase professional skills and competences in health~     professionals. It is expected that this study will contribute towards working with a joint~     PEWS model in Denmark. Last but not least it must be expected that a PEWS model will~     contribute to reducing the costs for society as an intensive care hospital bed is more~     expensive than a hospital bed at a general paediatric department.~   "
86617|NCT02433314|"~     This is an open-label, expanded access protocol, designed to offer treatment with SAGE-547 to~     subjects in SRSE, and to evaluate the efficacy and safety of SAGE-547 administered as a~     continuous intravenous infusion to these subjects~   "
86618|NCT02433301|"~     The incidence of malignity in the gastroesophageal junction (GEJ) is rising in Denmark, 400~     new cases annually 1. 60% of the patients with GEJ cancer have disseminated disease~     (M1-stage) at time of diagnosis and are consequently unable to undergo curative intended~     surgery. The prognosis is poor, with 5-year survival rates of approximately 2 % for these 60%~     and the treatment only consists of palliative therapy 1. For the remaining approximately 40 %~     who are assessed as candidates for curative intended surgery, the 5-year survival rate is 33~     % 1. This emphasizes the need for further research and knowledge concerning tumour biology~     and spontaneous course of the disease.~      In Denmark, all cancer patients are enrolled in a specific cancer program. The primary~     diagnostic work-up for GEJ cancers includes gastroscopy with biopsy, blood samples,~     ultrasonography scan, Positronemissionstomography (PET) and Computed tomography (CT) alone or~     PET/CT in combination 2. From these parameters physicians determine resectability and~     TNM-stage (tumour staging), which is substantial for the prognosis and future treatment. The~     primary goal is to achieve a macroscopically resection of tumour and lymphnodes in relation~     to the stomach and oesophagus (Esophagectomi a.m. Ivor Lewis and D1+ lymphadenectomy in the~     abdomen and thorax). In addition to surgery, patients receive perioperative chemotherapy,~     which consist of three series of chemotherapy preoperative and three series postoperative~     approximately 21-28 days after surgery.~      Approximately 12.6 % of patients receiving perioperative chemotherapy prior to surgery will~     have disease progression due to chemotherapy resistance during the therapy 3. This~     unintentionally leads to shifting these patients from the resectable group to non-resectable~     group (palliative treatment). Thus, the possibility for detecting response to perioperative~     chemotherapy is of great interest. A paradigm shift towards an individualised tailored~     therapy form has emerged in recent years, which potentially require a higher need for~     diagnosis on molecular level. Today most molecular biological methods apply tissue samples~     for in-vitro analyses, but new radiological tools provide opportunity for non-invasive~     examinations; for example PET can with a radioactive sugar compound: Flour-18 deoxyglucose~     (18F-FDG). This compound is injected through a catheter in a larger vein (media cubiti vein)~     and absorbed in cells with increased metabolism - especially cancer cells. A PET scanner~     registers the absorption; this radiology modality can provide valid information, which is~     essential for non-invasive tumour staging and monitoring response under a specific therapy.~      A new diagnostic modality is PET scan combinated with magnetic resonance (PET/MR)~     simultaneously. So far, no studies have conducted an evaluation of simultaneous PET/MR scan~     to assess the perioperative chemotherapy response in patients with GEJ cancer. However, some~     studies suggest that commercially available PET/MR scanner might contribute in a diagnostic~     elucidation 6. Simultaneous PET/MR scan might in theory minimize the misinterpretations of~     potential response changes after chemotherapy, which can appear in the interval between~     separate PET, CT and MR scans 4,5,7. Studies have found PET scan of GEJ cancer could be~     helpful as a prognostic tool to differentiate between responders and non-responders during~     chemotherapy 9. Standardized uptake value (SUV) is a unit that display the absorption of~     18F-FDG and is used routinely to quantify tumour glucose metabolism in PET scan 8. A change~     of more than 35 % in SUV measurements before and after the induction of chemotherapy is~     considered as the definition of responders and non-responders in earlier studies 9.~      The MR technique is based on magnetic fields and radio waves. Diffusion Weighted Imaging~     (DWI) is a non-invasive MR-modality, which measures the changes in water diffusion (Brownian~     movements) throughout tissue. These changes are measured in Apparent Diffusion Coefficient~     (ADC), a parameter derived from DWI and reflects the change in diffusion 7. ADC and DWI can~     be used to differentiate between benign and malignant tumours, due to a larger cell density~     in malignant tumours. Consequently, malignant tissue has a decreased diffusion relative to~     normal tissue. ADC has been used as a factor in some studies to predict the response to~     chemotherapy 10. A single study has shown a rise in ADC-value two weeks after initiation of~     chemotherapy in patients with GEJ cancer, and demonstrated that the percentage change in~     ADC-value between the groups (responders and non-responders) is significantly different 11.~     Simultaneous PET- and MR scan might be very useful to evaluate the response to chemotherapy~     in patients with GEJ cancer compared with these parameters alone. The opportunity for a more~     individualised tailored treatment in future might be possible with PET/MR.~   "
86619|NCT02433288|"~     This is a randomized, two-arm, open label, Phase IV clinical trial to evaluate if the~     provision of a smart phone-based patient support tool prolongs the patient's rosuvastatin~     treatment duration.~   "
86620|NCT02433275|"~     CHildhood ASthma and Environment Research study - CHASER study is an observational~     longitudinal study in outpatient clinic of Pediatric Allergology & Pulmonology (PAP) of~     Respiratory Disease Research Center (RDRC) within the Institute of Biomedicine and Molecular~     Immunology (IBIM) of the National Research Council (CNR) of Palermo (RDRC-IBIM CNR), Italy.~      The first phase - transversal study will identify determinants of pediatric asthma control~      The second phase - longitudinal study (2 year follow-up), in patients with persistent asthma,~     will be focused on:~        -  predictors for asthma exacerbations and loss of control~        -  real life adherence to asthma therapy guidelines~        -  phenotypic characterization through the collection of saliva samples~        -  assessment of alterations and inflammatory changes in the nasal mucosa through nasal~          brushing~      Chaser Project is expected to improve the knowledge of pediatric asthma in patients with~     different level of control, identifying predictors for asthma exacerbations and loss of~     control.~   "
86621|NCT02433262|"~     Aim for this study is to measure the prevalence of Gestational Diabetes Mellitus (GDM) using~     World Health Organisation (WHO) versus International Association of Diabetes in Pregnancy~     Study Group (IADPSG) criteria among pregnant mother in Universiti Kebangsaan Malaysia Medical~     Centre (UKMMC)~   "
86622|NCT02433249|"~     The purpose of this pilot study is to develop an intervention, based on empirical evidence~     and health-related behavioral change theory, to enhance motivation for engaging in~     fall-reducing physical activities.~   "
86623|NCT02433236|"~     Phase 2, multi-center, open label extension study to evaluate 2 dose regimens of fostamatinib~     in approximately 25 subjects. The study will consist of 11 visits over 15 months.~   "
86624|NCT02433223|"~     The purpose of this project is to evaluate hospital utilisation, patient and service outcomes~     of a Respiratory Nursing Service to examine current clinical care of COPD. This evaluation~     aims to identify the important gaps in current clinical care of respiratory chronic disease~     nursing management. The primary outcomes of this evaluation is to determine the efficacy of~     clinical care in 2006, 2011, 2013 and 2015 and compare data to current Nursing Best practice~     guidelines for COPD through the quantification of hospital utilisation for hospital~     admission, average length of stay, readmission within 28 days, emergency service attendance,~     outpatient review, use of Hospital and Home (H@H), frequency of exacerbations, disease~     severity and progression (FEV1: GOLD Classification), number of contacts with the respiratory~     nursing service and type of contacts with the respiratory nursing service.~   "
86625|NCT02433210|"~     The aim of the study is to confirm the safety and clinical effectiveness of Nipro ELISIO-15H~     and to compare its performance characteristics and hemocompatibility with those of the~     commercially available dialyzers in U.S.A., Gambro Polyflux Revaclear and Fresenius F160NRe.~      10 stable patients will be dialyzed 3 times/week with each dialyzer over 3 weeks. Blood~     samples for several parameters will be collected during hemodialysis to assess the~     performance and hemocompatibility of the dialyzers under study. Data thus collected will be~     analyzed for comparison by standard statistical analysis.~   "
86637|NCT02433054|"~     The purpose of this study is to examine patency rates of self-expanding nitinol stents for~     treatment of iliofemoral and inferior vena cava residual thrombosis, obstruction or stenosis.~     Moreover, clinical outcome data of patients treated with these venous stents will be~     collected.~   "
86626|NCT02433197|"~     Background: Patients with testicular germ cell cancer (GCC) have a high cure rate, however~     impaired muscle function and fatigue are the most common complications among patients with~     GCC undergoing treatment with chemotherapy. Although exercise is widely recommended,~     information about physiopathological effects of cancer therapy in skeletal muscle is very~     limited.~      Methods/Design: The present study is a randomized controlled trial comparing an~     individualized program of muscular strength and endurance with aerobic training compared to a~     control group. All variables will be measured at the beginning and at the end of a 8-week~     intervention by the same evaluator, who will hide the disposition of participants to each~     group. Besides, it will be monitoring during de following 6 months (24 weeks) after training~     for all outcome variables.~   "
86627|NCT02433184|"~     The main aim of the study is to determine whether TNFi instituted as first-line therapy in~     early RA confers better outcomes (clinical, structural and immunological) compared to delayed~     TNFi start; implying particular dominance of TNF in early disease, a changing role of TNF~     with disease duration and hence, confirmation of a biological window of opportunity.~   "
86628|NCT02433171|"~     The goal of this protocol is to evaluate the potential of PET imaging of amino acid transport~     and microglial activation to improve the differentiation of tumor recurrence and radiation~     necrosis in patients with brain metastases after treatment with stereotactic radiosurgery~     (SRS) who have re-growing lesions. These state-of-the-art imaging tools will be used in~     combination with standard magnetic resonance imaging (MRI), MR spectroscopy (MRS) and FDG-PET~     (fluorodeoxyglucose).~   "
86629|NCT02433158|"~     This is an open label extension study in subjects with Sickle Cell Disease (SCD) who have~     completed the double blind Phase 3 study (B5201002).~   "
86630|NCT02433145|"~     The current study using the longitudinal study in preschool children to exam three study~     issues: 1) using the neuropsychological functions (ie. Behavioral inhibition, delay aversion,~     the variability of reaction time) among the preschool children predict the ADHD diagnosis and~     behavior symptoms in 1.5 years later. 2) using the behavior inhibition, delay aversion and~     the variability of reaction time (using the parameter among Gaussian distribution and~     ex-Gaussian distribution) explore the association between attention and motor inhibition~     problems. 3) explore the transaction effect between the neuropsychological functions and~     family function and parenting to predict ADHD comorbidity with oppositional defiant~     disorder.4) explore the association between the internalizing/ externalizing problems of ADHD~     and temperament. The current study has opportunity to describe and to answer the complicated~     problems for heterogeneous neuropsychological deficits in ADHD, and to elucidate the core~     issues for ADHD have comorbid with ODD. The most important contribution is to offer the~     empirical evidence to make a clean suggestion in ADHD diagnosis and intervention in preschool~     age.~   "
86631|NCT02433132|"~     The diagnosis of CF is currently based on the discovery of two CFTR gene mutations and / or a~     positive sweat test (> 60mmol / l). A significant number of patients with atypical cystic~     fibrosis (chronic sino-pulmonary disease with a single mutation in the CFTR gene and / or a~     test of the intermediate sweat between 30 and 60 mmol / l) undetected by these techniques are~     behind specialized care while irreversible lung damage is already existed. Currently, the~     measurement of nasal potential difference in vivo (DPN), which evaluates the transportation~     of chlorine in the nasal epithelium with an electrode, is proposed for the diagnosis of~     atypical forms. However DPN dependent nasal local conditions when analysing do not always~     offer the possibility of concluding the diagnosis of cystic fibrosis. It is necessary to~     develop new and more reliable diagnostic tests for the detection of cases of atypical cystic~     fibrosis. The authors propose to develop a new diagnostic technique based on the study of~     bioelectric properties of a preparation of nasal cells of the subject obtained by brushing~     and placed in primary culture (CCBN).~   "
86632|NCT02433119|"~     A multi-center, randomized, double-blind, phase IV clinical trial to compare the efficacy and~     safety of OROSARTAN® tablet 5/160mg versus CODIOVAN® tablet 160/12.5mg in patients with~     essential hypertension uncontrolled with valsartan 160mg monotherapy~   "
86633|NCT02433106|"~     A randomized control trial examining the effects of an exercise based injury prevention~     programme on postural control and jump landing mechanics. Randomization of 4 teams, 2 Gaelic~     football and 2 hurling teams to exercise intervention and control groups. Participants are~     tested using Y Balance test and Landing Error Scoring System (LESS).~   "
86634|NCT02433093|"~     The study will assess the safety, tolerability, and pharmacokinetics of basimglurant compared~     to placebo after multiple ascending oral doses for up to 22 days in healthy subjects and in~     patients with MDD on stable selective serotonin reuptake inhibitor (SSRI) or~     serotonin-norepinephrine reuptake inhibitor (SNRI) background therapy.~   "
86635|NCT02433080|"~     Endometrial cancer is the most common gynaecological cancer in developed countries with more~     than 75% of the patients surviving for at least five years. However, most endometrial cancer~     survivors are overweight and obese and do not meet the current nutrition and physical~     activity recommendations. This can lower their quality of life and increase their risk for~     chronic diseases. Behaviour change interventions can help them feel better about themselves~     and improve their quality of life. Applying them shortly after treatment seems ideal as~     cancer survivors feel motivated to make changes about their lifestyle at this time point.~      This study is to see if the investigators can design a project to measure how well a~     psycho-educational healthy eating and physical activity programme tailored to the survivors'~     needs works. Sixty-four endometrial cancer survivors diagnosed during the previous three~     years, and are all clear will be put by chance into one of two groups. One will receive the~     program. The other will receive usual care until the end of the trial and, then, a discussion~     and a self-help guide about eating well and being active following cancer treatment. This~     will help us to see if the programme makes a difference compared with usual care. The results~     will inform a larger study to test if a lifestyle program can improve the quality of life of~     uterine cancer survivors compared with usual care. The investigators will change the~     programme materials in response to the investigators' findings, making them available to~     services. The results will inform practice and research.~   "
86636|NCT02433067|"~     Purpose of the study is to examine the effects of 3 months of physical activity intervention~     on myocardial function (Left ventricular ejection fraction) in patients with HER2+ breast~     cancer~   "
86639|NCT02433028|"~     The key aims of the Swiss Multiple Sclerosis Cohort-Study (SMSC) are~        1. To maintain a long-term cohort (>10 years) representative of the MS population currently~          living in Switzerland. This requires effective measures to limit drop-outs and the~          continuous recruitment of MS patients and~        2. To conduct a systematic follow-up with standardized, high quality collection of clinical~          and magnetic resonance imaging (MRI) data, as well as body fluids.~      The significant heterogeneity within the diagnostic entity and phenotype of multiple~     sclerosis (MS) is incompletely understood. A central and necessary prerequisite of further~     advance is a sufficient amount of high quality clinical and paraclinical (imaging, body~     fluids) patient data.~      Nested projects will address specific research topics, and facilitate collaboration of the~     most qualified investigators within the group of SMSC investigators. The nested projects will~     focus on the:~        1. Development and validation of diagnostic and prognostic markers of spontaneous disease~          evolution and therapeutic response.~        2. Exploration of the safety and impact on long-term disability of existing and next~          generation MS treatments~        3. Individualized therapy: A number of highly active but potentially also harmful therapies~          have lately been established for the treatment of MS. To date, due to the lack of~          individual prognostic markers patients may not receive aggressive therapy due to safety~          concerns, or patients with benign disease may receive expensive and potentially harmful~          treatments without the need for it.~   "
86640|NCT02433015|"~     The objective of this study is to examine the cognitive, immunological, and~     neurophysiological effects of transitioning from tobacco cigarettes to electronic cigarettes.~     The central hypothesis of this study is that this transition will be accompanied by a~     decrease in peripheral inflammation, which will lead to significant changes in the~     neurocircuitry underlying interoception and appetite.~   "
86641|NCT02433002|"~     The eGFR-C study will assess the accuracy of current and alternative tests of kidney function~     against a reference test in people with moderate (stage 3) chronic kidney disease (CKD).~   "
86642|NCT02432989|"~     This is a Phase 1 study to determine (1) the safety of an exercise protocol in adolescents~     and young adults with concussion in the first week post-injury and (2) to evaluate the~     effects of mild symptoms on brain function using EEG. This pilot study will inform subsequent~     grant applications, and a Phase II randomized control trial that will explore the influence~     of age on an early re-introduction to exercise, as well as the influence of varying intensity~     levels of exercise.~   "
86643|NCT02432976|"~     A diminution of quality of life is often reported by patients after coronary artery bypass~     graft (CABG) surgery. A part of this diminution could be explain by postoperative left~     ventricular (LV) dysfunction.~      Exenatide (Byetta®) is an incretin mimetic, characterized by an anti-hyperglycemic effect~     that depends on the blood glucose level. Recent data have suggested that exenatide could~     improve LV function by an inotropic effect in patients suffering from cardiogenic shock or~     from congestive heart failure. Moreover, patients suffering from congestive heart failure~     reported a better quality of life when they were treated with exenatide compared to placebo.~      The investigators hypothesize that perioperative exenatide infusion could improve~     postoperative quality of life in CABG surgery patients.~   "
86644|NCT02432963|"~     This phase I trial studies the side effects of vaccine therapy and pembrolizumab in treating~     patients with solid tumors that have spread to other places in the body and usually cannot be~     cured or controlled with treatment, that have failed prior therapy, and that cannot be~     removed by surgery. Vaccines made from a gene-modified virus may help the body build an~     effective immune response to kill tumor cells. Monoclonal antibodies, such as pembrolizumab,~     may block tumor growth in different ways by targeting certain cells. Giving vaccine therapy~     together with pembrolizumab may be a better treatment in patients with solid tumors.~   "
86645|NCT02432950|"~     This pilot clinical trial studies a pancreatic nutritional program for helping patients with~     stage I-III breast cancer who are overweight or obese lose weight. When patients have a high~     level of sugar in their blood, due to eating sugary foods and/or a sedentary lifestyle, the~     pancreas needs to work harder to digest the sugar. This can cause weight gain, obesity, and~     other illnesses. Breast cancer patients who are overweight and obese are more likely to have~     their breast cancer return. The pancreatic nutritional program is a diet and lifestyle~     intervention that helps protect the pancreas by keeping blood sugar levels low, and may help~     patients achieve sustained weight loss, improved health, better quality of life, and possibly~     a better outcome to their treatment.~   "
86646|NCT02432937|"~     The study primarily aims to compare the effects of two doses of Corever with placebo in~     patients with hypertension.~   "
86647|NCT02432924|"~     The primary aim of the study is to examine whether the provision of personalised~     multidimensional physical activity profiles (derived from technological advances in physical~     activity monitoring) is supported by instantaneous physical activity feedback in fostering a~     meaningful change in physical activity behaviour amongst adults.~   "
86648|NCT02432911|"~     This study focus on the comparison of CAG regimen to the low dose cytarabine therapy in~     elderly AML patients who are unfit or unwilling to receive intensive chemotherapy.~   "
86649|NCT02432898|"~     Evaluate the clinical information obtained from the use of the machines.~   "
86650|NCT02432885|"~     This trial intends to evaluate myocardial Fibrosis progression in Duchenne and Becker~     Muscular Dystrophy, as well the influence of ACE inhibitors in fibrosis progression.~     Additionally, this study aims to determine genetic predictors of cardiac involvement in these~     dystrophies.~   "
86651|NCT02432872|"~     The purpose of this study is to determine whether the escalation dosage of Daunorubicin and~     cytarabine is effective and safety in the treatment of older adult Chinese acute myeloid~     leukemia（AML） patients aged 55 to 65 years.~   "
86652|NCT02432859|"~     The purpose of this study is to determine whether electrical stimulation is effective in the~     expression of VEGF, VEGFR-2, HIF-1α and NO and healing in diabetic foot ulcer.~   "
86653|NCT02432846|"~     The purpose of this study is to compare tumor response, progression free survival (PFS) and~     overall survival (OS) in newly diagnosed mRCC patients treated with Intuvax pre-nephrectomy~     followed by Sunitinib post-nephrectomy vs Sunitinib post-nephrectomy in non-vaccinated~     patients.~   "
86731|NCT02431832|"~     An open-label, one-sequence, multiple administration study for exploration of microRNA and~     metabolomics biomarkers to predict drug induced liver injury in healthy elderly Korean~     people.~   "
86655|NCT02432820|"~     SPECIFIC STUDY AIMS~        1. To evaluate congruence between pelvic anatomical structures segmented on MRI and/or CT~          scans co-registered with transperineal US scans acquired with an optically and/or~          electromagnetically tracked matrix array ultrasound transducer.~        2. To estimate the achievable accuracy of anatomy tracking based on 3D US matrix-array~          transducer imaging and grey-level based image registration algorithms.~   "
86656|NCT02432807|"~     This is a Phase 3 study to evaluate the safety and efficacy of a vancomycin hydrochloride~     ophthalmic ointment dosed 4 times daily for 7 days compared to placebo (vehicle) in patients~     with moderate to severed Gram-positive bacterial conjunctivitis.~   "
86657|NCT02432794|"~     This is a randomized clinical trial to clarify if the delay phenomenon could reduce the~     incidence of oesophagogastric dehiscence after an esophagectomy for esophageal cancer~     comparing an experimental group vs control group. The delay phenomenon will be performed by~     an arteriographic approach.~   "
86658|NCT02432781|"~     The primary purpose of this study is to investigate the effects of carbohydrate-rich drink on~     postoperative nausea and vomiting in diabetic patients undergoing total knee arthroplasty.~     The secondary purpose is to investigate the effects of carbohydrate-rich drink on quality of~     recovery and inflammation in diabetic patients after total knee arthroplasty.~   "
86659|NCT02432768|"~     Background: Patients with the sugar metabolism disorder, Glycogen Storage Disease Type V,~     have insufficient breakdown of sugar stored as, glycogen, within the cells. The investigators~     know from previous studies with McArdle patients, that they not only have a reduced sugar~     metabolism, both also have problems in increasing their fat metabolism during exercise to~     fully compensate for the energy deficiency.~      Studies on Triheptanoin diet used in patients with other metabolic diseases have shown that~     Triheptanoin can increase metabolism of both fat and sugar. In these patients, Triheptanoin~     has had a positive effect on the physical performance and has reduces the level of symptoms~     experienced by patients.~      Aim: To investigate the effect of treatment with the dietary oil, Triheptanoin, in patients~     with McArdle disease on exercise capacity.~      Methods: 20-30 adult patients will be recruited through Rigshospitalet in Copenhagen,~     Denmark, Hopital Pitié-Sapêtrière in Paris, France and through The University of Texas~     Southwestern Medical Center in Dallas, Texas.~        1. Pre-experimental testing (1 day):~           Baseline blood samples are collected to obtain baseline values of safety parameters:~          Plasma-acylcarnitines, free fatty acids and creatine kinase.~           Subjects perform a max-test to determine their VO2max~        2. Treatment period #1 (2 weeks):~           Subjects follow a diet consuming a dietary treatment oil. Neither patients nor members~          of the study group know who receive which type of oil.~        3. Washout period (1 week):~           Subjects receive no treatment~        4. Treatment period #2 (2 weeks):~      Subjects who received Triheptanoin oil in the first treatment period, now receive placebo oil~     and vice versa.~      Assessments: Before and after each treatment periods, subjects perform a 30-minutes exercise~     test on a cycle ergometer, comprising of 20-22 minutes of constant load exercise and 6-8~     minutes increasing load to peak. Subjects will complete a Fatigue Severity Scale~     questionnaire and metabolic products will be measured in blood and urine.~   "
86660|NCT02432755|"~     The specific aims of this study will be:~        1. To compare the immediate and retention treatment effects of the patients receiving~          home-based mirror therapy combined with task-oriented training (MTOT) with a~          hospital-based MTOT group and a hospital conventional rehabilitation group on different~          aspects of outcomes.~        2. To examine the feasibility, satisfaction, and safety of this novel home-based MTOT~          program.~        3. To investigate the factors that may affect the efficacy of home-based stroke~          rehabilitation.~   "
86661|NCT02432742|"~     The purpose of this study is to determine the safety and efficacy of using Restylane Perlane~     compared to Restylane for correction of moderate to severe nasolabial folds (NLF) in a~     Chinese population.~   "
86662|NCT02432729|"~     The purpose of this study is to understand the biological and functional changes after one~     year of smoking cessation and to collect data on a broad range of biomarkers of exposure~     (BoExp).~   "
86663|NCT02432716|"~     This study is a single center, randomized, double-blind, placebo-controlled, cross-over pilot~     study designed to assess the safety of intranasally (IN) delivered glulisine versus placebo~     in patients with DS. Subjects will be randomized into this cross-over study and within~     subject comparisons conducted between single treatment of intranasal insulin glulisine and~     single treatment of intranasal placebo. All subjects will also receive a single treatment of~     placebo prior to randomization to ensure adherence to study procedures.~   "
86664|NCT02432703|"~     The purpose of this study is to investigate the efficacy of JNJ-42165279 during 12 weeks of~     treatment in participants with Social Anxiety Disorder (SAD).~   "
86665|NCT02432690|"~     This is an open label, single-arm, phase II study. The study population is adult patients~     with asymptomatic recurrent ovarian cancer who have an elevation in their CA-125 level.~   "
86666|NCT02432677|"~     The purpose of this study is to evaluate the potential additive effect of tDCS compared to~     placebo-sham in opioid analgesia on pain thresholds in nociceptive experimental model in~     healthy volunteers .~   "
86667|NCT02432664|"~     The purpose of the study is to investigate to what extent this new study drug is tolerated in~     humans.~      The study is divided into 3 parts (Part III is optional and may go ahead depending on the~     results of Parts I and II). The volunteers will only be enrolled to one part of the study. In~     parts I and II the volunteer will receive active study drug or placebo. In part I the~     volunteers will receive a single dose of one of the eight planned escalating dose levels.~      In part II volunteers will receive 4 planned dose levels based on the results obtained in~     Part 1 of the study, with the option to include an additional dosing group.~      In optional part III the volunteer will receive ODM-108 and an already registered drug so~     that interactions with other drugs can be studied.~      It will be investigated how quickly and to what extent the study drug is absorbed and~     eliminated from the body (this is called pharmacokinetics). In addition, in parts I and II~     the effect of the compound on the sensation of pain and on cognition (activities of thinking,~     understanding, learning, and remembering) will be investigated (this is called~     pharmacodynamics).~   "
86668|NCT02432651|"~     The purpose of this research study is to learn if and in what amount a compound from hops,~     called xanthohumol (ZAN-tho-HUE-mol), prevents damage to DNA and oxidative stress. The human~     body is constantly exposed to oxidative stress from environmental compounds (e.g. air~     pollution) which may cause damage to DNA. The human body can repair some DNA damage, but too~     much DNA damage is harmful and may lead to cancer. Research done at OSU and around the world~     has shown that xanthohumol can stop or slow processes that lead to cancer.~   "
86669|NCT02432638|"~     The purpose of this prospective, multi-center, longitudinal study is to assess clinical~     outcomes related to the surgical treatment of PRS ( Pierre Robin Sequence) by MDO (Mandibular~     distraction osteogenesis). This study aims to develop a scoring system to determine success~     and complication rate pre and post MDO.~   "
86670|NCT02432625|"~     Osteogenesis Imperfecta (OI) is a rare disorder that causes bones to break easily. People~     with OI may have broken bones with little or no trauma, dentinogenesis imperfecta (DI), and,~     in adult years, hearing loss. It is seen in both genders and all races. OI can range from~     very severe to very mild. Individuals with the most severe type of OI may die at birth.~     People with severe OI who survive may have bowed arms and legs, very short stature and be~     unable to walk. People with the mildest form of OI may only break bones occasionally and have~     normal height and lifespan. People with OI also often have problems with the spine. The spine~     problems include compression fractures and scoliosis (a curvature of the spine). DI is~     characterized by grey or brown teeth that may chip and wear down and break easily.~      Before the genetic cause of OI was known, OI was classified into four types. Each type was~     based upon the symptoms and severity of OI. In most people with OI, the cause is a change in~     one of the genes that makes a protein called type 1 collagen. In the past decade, it was~     discovered that in about 5% of people with OI it is in another gene. Some doctors now~     classify OI both on how severe it is as well as which gene is causing OI.~      Our research aims are:~        1. Perform DNA testing and collect natural history data on all individuals enrolled in this~          longitudinal study. The genetic cause of the brittle bone disease will be compared with~          things like severity, various features and response to treatments.~        2. We will see how often people with type I OI have vertebral compression fractures of the~          spine. We will do x-rays to see how often they get compression fractures of the~          vertebrae, what happens over time and any risk factors that increase the risk of these~          compression fractures.~        3. We will follow people with all forms of OI to see how often they develop scoliosis~          (curvature of the spine). We will look at the effects of scoliosis on lung function,~          ability to walk and quality of life. We will also look at the effects of various~          treatments (bracing, surgery, etc.) on scoliosis and lung function.~        4. We will look at dental health in people with OI. We will see how often people with OI~          have problems with teeth alignment. Importantly, we will see how dental health impacts a~          person's quality of life.~   "
86671|NCT02432612|"~     The purpose of this study is to evaluate the pharmacokinetics (PK) of a single oromucosal~     dose of Sativex in subjects with advanced cancer currently on background Step III opioid~     therapy.~   "
86672|NCT02432599|"~     The rationale for the proposed pilot study is to investigate the ability of PET-CT with~     F18-choline to detect and locate the parathyroid adenoma in patients with primary~     hyperparathyroidism and negative or non-contributory MIBI (Tc-99m sestamibi) and cervical~     ultrasound, in order to avoid unnecessary bilateral cervical exploration.~   "
86673|NCT02432586|"~     18 preschool aged children and their families will attend structured, multidisciplinary,~     family-centered intensive education sessions over a 3-day weekend in a residential camp~     setting to address the unique challenges of managing type 1 diabetes mellitus in young~     children. A second 'booster' session, will be conducted 6 months later.~   "
86674|NCT02432573|"~     In postpartum hospitalized women, does delayed morning rounding improve patient satisfaction?~   "
86675|NCT02432560|"~     The MIDAS study aims to follow women with LAM who are currently taking, have previously~     failed or been intolerant of, or are considering treatment with mTOR inhibitors sirolimus or~     everolimus as part of their clinical care.~   "
86676|NCT02432547|"~     This will be a 24 month phase IV, randomised, prospective, multicentre, clinical trial of~     laser therapy to areas of peripheral retinal ischaemia combined with intravitreal aflibercept~     versus intravitreal aflibercept monotherapy. Both arms will have 2mg intravitreal aflibercept~     according to a treat and extend protocol.~      The specific aim of the study is to test whether laser therapy of peripheral retinal~     ischaemia reduces the overall number of intravitreal aflibercept injections required to~     control DMO over a 24 month period.~   "
86677|NCT02432534|"~     Condition:~      Non segmental and active vitiligo of adulthood.~      Main objective:~      To evaluate the efficacy of a daily treatment with atorvastatin 80mg/d combined to UVB~     compared to UVB alone in active vitiligo after 6 months of treatment.~      Methods:~      Prospective interventional bicentric study with evaluation blinded to the treatment received.~      Inclusion criteria:~      Patients from 18 to 75 year-old with active non segmental vitiligo. Active is defined by the~     apparition or the modification of vitiligo lesions with the past 3 months and under Wood's~     lamp examination hypochromic borders and/or spotty depigmentation.~      Interventions:~      After central randomization~        -  Arm A : atorvastatin 40mg/d for 1 months then 80mg/d for 5 months combined with twice~          weekly narrowband UVB treatment for 6 months.~        -  Arm B: with twice weekly narrowband UVB treatment for 6 months.~      Evaluation:~      Main criteria: Decrease of VASI score expressed in percentage Secondary criteria: Decrease of~     VETF score expressed in percentage. Variation of PGA and DLQI scores. Clinical and biological~     tolerance. Variation of CXCL10 levels in the serum.~      Length of the study:~      Inclusion period: 12 months. Length of treatment: 6 months. Statistical analyses and drafting~     the article: 6 months. Total length: 24 months.~   "
86678|NCT02432521|"~     The cerebrovascular accident (CVA) is currently the leading cause of death in Brazil and it~     is estimated that there are about 62 million stroke survivors worldwide. Thus, the stroke~     sequels are a major public health problem not only in Brazil but in the world, with existing~     treatments often insufficient for complete recovery. Thus this study aims to identify~     predictors of different responses from rehabilitation therapy through the evaluation of~     clinical and neurophysiological data performed before and after treatment. For the~     neurophysiological study will be used the association of electroencephalogram (EEG) and~     transcranial magnetic stimulation (TMS). This last one will be performed in the baseline and~     after a single Transcranial direct current stimulation (tDCS) session, aiming to leverage the~     ability of those technics to analyze the cerebral plasticity. As a secondary objective: 1)~     Identify specific features of brain plasticity involved in recovery from stroke and discuss~     the possible implications of these findings in the therapeutic approach; 2) Search possible~     electrophysiological markers that can be used as surrogate outcome of stroke of motor sequel.~   "
86679|NCT02432508|"~     Uremic pruritus is a clinically significant symptom which imposes heavy impact on the quality~     of life of patients with chronic kidney disease undergoing hemodialysis. In order to~     investigate the clinical efficacy and mechanism, the investigators designed a multiple~     centers, randomized, assessor- and participant-blind, controlled, cross-over clinical trial.~     This trial will be conducted at Taichung branch, Feng-yuan branch and the Eastern branch of~     CMUH.~   "
86680|NCT02432495|"~     The management of type II odontoid fractures in geriatric trauma victims remains a source of~     substantial controversy. The purpose of this study was to compare anterior screw fixation~     with halo-vest-immobilization in patients with type II odontoid fractures.~   "
86681|NCT02432482|"~     The purpose of this study is to adapt an existing web-based tobacco treatment program for~     HIV-infected smokers into a mobile intervention delivered via smartphone. After the~     adaptation is completed, the investigators will test the program's efficacy at promoting~     abstinence in a randomized controlled trial.~   "
87438|NCT02422563|"~     Randomized comparison of neoadjuvant chemotherapy followed by radical hysterectomy with~     pelvic ± para-aortic lymphonodectomy (LNE) versus primary cisplatin-based chemo-radiation in~     patients with cervical cancer FIGO IB2 and IIB.~   "
86682|NCT02432469|"~     The study is a randomized controlled trial, having a plan to recruit 1000 patients underwent~     coronary artery bypass grafting in 1 of 5 participating sites in 2015, and randomized to~     either the intervention group or control group, to test the effectiveness of a smartphone~     based application (APP) focusing on improving patients medication adherence. Patients~     randomized to the intervention group install the APP in their smartphones with personnel~     information and physicians' medication descriptions. The APP reminds at the time of taking~     medications, educates them on secondary prevention for coronary artery disease, and collects~     their weekly situations by questionaires. Investigators will follow-up patients by face to~     face or telephone interview. The 6-month effects of the intervention are evaluated.~   "
86683|NCT02432456|"~     This study will evaluate the effectiveness of ketamine infusions in the management of acute~     pain resulting from broken ribs suffered following a blunt trauma. Half of patients will~     receive the institutional standard of care and a placebo infusion (no active medication). The~     other half of patients will receive the institutional standard of care and a ketamine~     infusion. All subjects and staff will be blinded as to whether they are receiving placebo or~     ketamine.~   "
86684|NCT02432443|"~     Children begin to develop fundamental motor skills (FMS), such as running and kicking, and~     pre-literacy skills, such as rhyming, during early childhood. These skills are very important~     as they lay the foundation for more complex movements and literacy skill development later in~     life, support overall healthy development in several areas, and help contribute to the~     child's readiness for school. A child with strong motor skills is well equipped to lead a~     life with healthy levels of physical activity, positive social interactions, positive~     self-perceptions, and greater cognitive and language abilities. These skills will not develop~     optimally on their own so it is essential to teach, challenge, and reinforce them at an early~     age; often this learning takes place at home prior to entering school. Most research on this~     topic has primarily focused on school-aged children or children with specific developmental~     challenges and less is known about teaching motor and pre-literacy skills to young children~     and giving parents the tools to practice these skills at home with their children. The aim of~     the present study is to examine the effect of a motor and pre-literacy program, which~     emphasizes parental involvement, on motor, pre-literacy, social skills, cognitive abilities,~     and self-competence in 3 to 4 year old children with typical development.~   "
86685|NCT02432430|"~     Dissemination research examines the processes and factors that lead to widespread use of~     evidence-based interventions. There are several theories on how to best minimize the~     perceived and actual burdens on practitioners associated with implementing evidence-based~     medicine. For instance, the pay for performance model attempts to improve physician~     compliance with quality guidelines by providing financial incentives. Recent studies suggest~     pay for performance is effective in improving practitioner performance, but it is unclear~     whether the gains are sustainable once incentives are stopped.~      Another approach to promoting best practices is the Model for Improvement whose main method~     is to employ Plan-Do-Study-Act (PDSA) cycles of small changes Although this approach has been~     successful within individual institutions, there is minimal evidence of its effect when~     employed simultaneously in multiple autonomous institutions. There is also little evidence of~     the sustainability of outcomes after intervention activities end.~      The specific aims of the proposed study are to examine the effect of quality improvement~     dissemination models on the immunization coverage of children ages 3 to 18 months old. The~     investigators propose to:~      1. Determine the effect on immunization compliance of two different models of dissemination~     which will provide physicians 12 months of quality improvement (QI) activity support for~     implementing CDC immunization best practices.~      Hypothesis 1a: Study participants receiving the QI technical support intervention (QITS) will~     have more improvement in immunization rates from baseline to immediately after support ends~     than participants receiving the pay for performance intervention (P4P).~      Hypothesis 1b: Study participants receiving QITS will increase immunization coverage for~     their practices over baseline.~      Hypothesis 1c: Study participants receiving P4P will increase immunization coverage for their~     practices over baseline.~   "
86686|NCT02432417|"~     Glioblastomas (GBM) are the most common type of primary brain tumors with an annual incidence~     of approximately 500 patients in the Netherlands. Despite extensive treatment including a~     resection, radiation therapy and chemotherapy, the median overall survival is only 14.6~     months.~      Epidermal growth factor receptor (EGFR) amplification or mutation is regularly observed in~     GBM and is thought to be a major contributor to resistance to radiotherapy and chemotherapy.~     The most common EGFR mutation in GBM (EGFRvIII) is present in 30-50% of GBM.~      Previously MAASTRO lab has shown that expression of EGFRvIII provides GBM cells with a~     survival advantage when exposed to stress factors such as hypoxia and nutrient deprivation.~     These metabolic stress factors activate a lysosomal degradation pathway, known as autophagy.~     Inhibition of autophagy sensitizes cells to hypoxia, reduces the viable hypoxic fraction in~     tumors with > 40% and subsequently sensitizes these tumors to irradiation.~      Chloroquine (CQ) is a potent autophagy blocker and is the most widely investigated substance~     in this context. Previously, the effect of CQ has been demonstrated in a small randomized~     controlled trial in GBM treated with radiotherapy and carmustine. Although not statistically~     significantly different, the rate of death over time was approximately half as large in~     patients receiving CQ as in patients receiving placebo. The intracellular effects of CQ are~     dose-dependent. Therefore, the authors suggest an increase in daily dose of CQ may be~     necessary. Furthermore, the combination of CQ with TMZ may induce more damage to the~     neoplastic cells.~      In the phase I part of this trial the recommended dose of CQ in combination with radiotherapy~     and temozolomide will be tested. In the phase II part of the trial patients with a~     histologically confirmed GBM will be randomized between standard treatment consisting of~     concurrent radiotherapy with temozolomide and adjuvant temozolomide (arm A) and standard~     treatment plus CQ (arm B).~   "
86687|NCT02432404|"~     To assess potential benefits associated with both intermittent (use for 3 weeks, remove for 1~     week, as defined in the package insert) and continuous (use for 4 weeks, then replace) CVR~     use among women either with BV or at high risk for BV. The investigators will also recruit~     women who are HSV2-infected.~   "
86688|NCT02432391|"~     The purpose of this study is to determine if a lifestyle modification program (GEM) that~     focuses on reducing after-meal blood glucose elevations can improve blood glucose control in~     people with type 2 diabetes. Half of the participants will continue their routine medical~     care, and half will receive five sessions of GEM in addition to their routine care. The two~     groups will be assessed using diabetes-relevant medical, behavioral and psychological~     measures.~   "
86689|NCT02432378|"~     The main goal of this research study is to determine if intraperitoneal (IP) administration~     of cisplatin in addition to an investigational vaccine (the DC vaccine) with or without an~     investigational drug combination of IP rintatolimod, IP interferon alpha-2b (IFN), and oral~     celecoxib, has any effect, good or bad, on recurrent ovarian cancer.~   "
86690|NCT02432365|"~     The purpose was to establish a quick (7-day) cycle schedule of paclitaxel (60 mg/m2)~     combining with cisplatin (40 mg/m2) NAC regimen could be tolerated without interfering the~     following surgical treatment and a favorable overall survival rate for stages IB2 and IIA2~     cervical squamous cell carcinoma (SCC).~   "
86691|NCT02432352|"~     The purpose of this study is to assess the feasibility and acceptability of a family-based~     preventive intervention designed to reduce sexual risk behaviors and depressive symptoms~     among South African adolescents and their parents/guardians/caregivers.~   "
86692|NCT02432339|"~     The purpose of this study is to determine if stopping the stress induced increase in~     inflammation will prevent sodium retention which in turn increases blood pressure. Each~     subject will test two separate times. One week, they will be taking a daily dose of~     mycophenolate mofetil (MMF), the other week they will be taking a placebo.~   "
86693|NCT02432326|"~     This is an open label, multi-center, phase 1 study of BBI608 and BBI503 administered orally~     in combination to patients with advanced solid tumors. The primary goal is to determine the~     safety, tolerability, and recommended phase II dose (RP2D) of the combination regimen.~   "
86694|NCT02432313|"~     Parts 1 and 2:~      Subjects take 1 dose of various formulations of the study product, and provide samples for~     pharmacokinetic (PK) analysis after each, with at least 7 days between doses.~      Part 3:~      Subjects take 2-4 doses of study product or placebo for 6 days, plus 1 additional dose, and~     provides samples for PK analysis.~   "
86695|NCT02432300|"~     The purpose of this study is to examine a web-based training program for treating emotional~     problems in people who have suffered a traumatic brain injury (TBI).~   "
86696|NCT02432287|"~     Metformin, an FDA approved first-line drug for the treatment of type 2 diabetes, has known~     beneficial effects on glucose metabolism. Evidence from animal models and in vitro studies~     suggest that in addition to its effects on glucose metabolism, metformin may influence~     metabolic and cellular processes associated with the development of age-related conditions,~     such as inflammation, oxidative damage, diminished autophagy, cell senescence and apoptosis.~     As such, metformin is of particular interest in clinical translational research in aging~     since it may influence fundamental aging factors that underlie multiple age-related~     conditions. The investigators therefore propose a pilot study to examine the effect of~     metformin treatment on the biology of aging in humans. Namely, whether treatment with~     metformin will restore the gene expression profile of older adults with impaired glucose~     tolerance (IGT) to that of young healthy subjects.~   "
86697|NCT02432274|"~     This is a phase 1/2 study evaluating safety, tolerability, and efficacy of lenvatinib in~     children and adolescents with refractory or relapsed solid malignancies and young adults with~     Osteosarcoma.~   "
86698|NCT02432261|"~     This is a prospective, randomized, double-blinded, two-center trial to evaluate the~     gonadotropin suppressive activity of transdermal treatment with a combined NES/T gel, or T~     gel alone, for 28 days.~   "
86699|NCT02432248|"~     The purpose of this study is to investigate the effect of DHEA for treatment of subfertile~     patients with poor ovarian reserve and post-treatment evaluation of IVF outcome.~   "
86700|NCT02432235|"~     This study evaluates ADCT-301 in patients with relapsed/refractory Non-Hodgkin or Hodgkin~     lymphoma. Patients will participate in a dose-escalation phase (Part 1) and receive~     escalating doses of ADCT-301 every 3 weeks.~      In Part 2 of the study, patients will receive a recommended dose(s) of ADCT-301 every 3~     weeks.~   "
86701|NCT02432222|"~     The study will use a randomized controlled trial to test the efficacy of two interventions~     (visual arts and music) for individuals with dementia, focusing on dementia of the~     Alzheimer's type (DAT). Interventions will be run for 10 weeks in dementia day centers and/or~     retirement residences. Participants will be tested before and after the intervention on a~     battery of cognitive, affective, and behavioural measures. They will be compared to a~     waitlist control group who don't receive the intervention.~      The purpose of our research is twofold: treatment of symptoms and improved quality of life~     during disease progression in dementia. For the primary aim, the investigators are examining~     the potential of arts interventions on declining functions in dementia (memory, mood, and~     behavior) to investigate potential treatment effects. Secondly, quality of life will be~     measured, with the aim of looking beyond disease progression to contribute to an overall~     positive patient experience. Research has indicated the need for non-pharmacological~     treatments to be used as a first line of action against dementia symptoms and development.~     While, in best practice, pharmacological treatments should be used as a second-line approach.~      Note: Music intervention dropped prior to study initiation.~   "
86702|NCT02432209|"~     A two-arm, multicenter, prospective, randomized clinical trial of a lifestyle modification~     program with tracked increased physical activity and weight loss (intensive) compared to~     recommendations to tracking of increased physical activity alone with weight maintenance~     (standard) in women with obesity and unexplained infertility. This 16 week period of~     lifestyle modification will be followed by an open label empiric infertility treatment~     regimen consisting of three cycles of ovarian stimulation with oral medication (clomiphene~     citrate (CC)), triggering of ovulation with human chorionic gonadotropin (hCG) and~     intrauterine insemination (IUI).~   "
86703|NCT02432196|"~     This is a Prospective, Single Arm, Single Group Assignment, EU study to demonstrate the~     feasibility and safety of the Harpoon Medical TSD-5 in subjects with degenerative MR~   "
86704|NCT02432183|"~     In this study the investigators will study the lung function and airway inflammation in elite~     athletes starting at the elite sport school (age: 12-13 year) and the change in lung function~     parameters and airway inflammation after 1 and 2 years at the elite sport school in~     comparison to age-matched controls (exercising at a recreational level, <4 hours/week).~   "
86705|NCT02432170|"~     This study aims to compare digital tomosynthesis with radiography and weight-bearing CT as an~     imaging technique to assess arthritis in the foot and ankle.~   "
86706|NCT02432157|"~     Subarachnoid hemorrhage (SAH) occurs after rupture of cerebral aneurysms. Treatment of SAH~     focuses on avoiding medical complications including cerebral vasospasm, which may result in~     limited circulation to the brain. Cerebral vasospasm, or thinning of the arteries of the~     brain, is a feared complication that could potentially cause stroke and worst outcomes after~     SAH. Hypertonic saline (HTS) is a compound that may be used to prevent vasospasm following~     SAH by enhancing the circulation in the brain. This study will evaluate if a protocol of~     volume expansion with HTS is safe and effective in patients with subarachnoid hemorrhage for~     the prevention of cerebral vasospasm.~   "
86707|NCT02432144|"~     UX003-CL202 is an open-label, multi-center extension study to assess long-term safety and~     efficacy of UX003 treatment in patients with MPS 7.~   "
86858|NCT02430142|"~     Forearm vasoocclusive testing (VOT) will be performed with laser-doppler spectrophotometry~     system in septic patients on ICU. Microcirculatory oxygen uptake will be checked for~     prognostic value and for associations with tissue hypoxia markers and high central venus~     saturations.~   "
86708|NCT02432131|"~     The investigators will prospectively estimate incidences of decompression sickness in SCUBA~     divers with or without patent foramen ovale (PFO). All participants will receive~     transesophageal echocardiogram and transcranial doppler to ascertain whether they get a PFO.~     Clinical follow up will be undertaken 3 month after transesophageal echocardiographic~     evaluation, and every 6 month up to 3 years by E-mailing or telephone interview with~     self-questionnaire report. All decompression sickness (DC) events or DC-like symptoms will be~     reviewed by a professional diver, who is a medical doctor and member of DAN-AP, and a~     neurologist.~   "
86709|NCT02432118|"~     This pilot clinical trial studies the use of the radiofrequency-guided localization in~     patients with abnormal breast tissue undergoing lumpectomy (a type of breast-sparing~     surgery). The radiofrequency identification localization system consists of an implantable~     radiofrequency identification tag and a hand-held radiofrequency reader to mark abnormal~     breast tissue before surgery and later surgically retrieve them. Radiofrequency-guided~     localization may make it easier to find and remove abnormal breast tissue during lumpectomy.~   "
86710|NCT02432105|"~     The purpose of this study is to evaluate EXE844 plus tympanostomy tubes compared to~     tympanostomy tubes only based on sustained clinical cure at end-of-therapy (EOT).~   "
86711|NCT02432092|"~     The goal of this protocol is to obtain information from individuals with cardiomyopathy and~     from their families in order to elucidate the molecular genetics of this disorder. This will~     provide the basis for future genetic counseling as well as contribute to elucidating the~     biology of normal and abnormal cardiac function.~   "
86712|NCT02432079|"~     The goal of this study is to obtain specimens and data from individuals and their families~     with heterotaxy and related congenital heart defects in order to clarify the molecular~     genetics of this disorder. The knowledge gained from the analysis of this information will~     provide the basis for future genetic counseling as well as contribute to knowledge about the~     biology of normal and abnormal development of left-right anatomic asymmetry.~   "
86713|NCT02432066|"~     Attempts to quit cigarette smoking are often accompanied by negative mood and problems in~     attention and memory. These effects, in turn, may contribute to smoking relapse. This~     exploratory/developmental project examines the effects of a novel medication, GTS-21, on~     individuals interested in smoking cessation. It is hypothesized that GTS-21 will reduce~     negative affect, improve cognition and/or reduce smoking relapse in healthy adult men and~     women who are chronic cigarette smokers.~   "
86714|NCT02432053|"~     The objective of the study is to demonstrate safety and efficacy of once-daily Advagraf in~     adult population undergoing kidney or liver transplantation in India.~   "
86715|NCT02432040|"~     This study aimed to assess the efficacy and safety of atorvastatin 40 mg/day as an adjunct to~     betamethasone valerate 0.1% ointment applied twice daily in the treatment of patients with~     mild to moderate chronic plaque type psoriasis, as determined by mean reduction in PASI~     scores. Specific objectives included the determination and comparison of the absolute number~     and proportion of patients who achieved PASI-50 and the mean reductions in lipid profile~     (total cholesterol, HDL, LDL, triglycerides) and high-sensitivity C-reactive protein (hsCRP)~     measured from baseline and every month thereafter up to 6 months of treatment. This study~     also investigated the impact of atorvastatin treatment on the patients' quality of life as~     well as the association of clinical response to the lipid-lowering and anti-inflammatory~     effects of atorvastatin.~   "
86716|NCT02432027|"~     Evaluate the effects of topical C-82 in a psoriasis plaque test.~   "
86717|NCT02432014|"~     The purpose of this study is to gain a better understanding of family preferences for and~     engagement in services.~   "
86718|NCT02432001|"~     The purpose of this study is to better understand how cancer treatment may affect cancer~     cells. The research will involve genetic, molecular, cellular, and immunologic experiments~     using blood and tumor specimens. It is hoped that the information gained from these studies~     will lead to a greater understanding of castrate-resistant prostate cancer and potentially,~     improvements in cancer treatment.~      This is a tissue collection protocol requiring image-guided biopsies of metastatic,~     castration-resistant prostate cancer (mCRPC). The investigators will focus on enrolling~     patients with metastatic CRPC who have progressed while receiving novel AR-targeted~     therapeutics such as abiraterone and enzalutamide. This population of patients was selected~     because resistance develops relatively rapidly following potent inhibitors of AR activity and~     the mechanisms of resistance have to be better understood. Without comprehensive analysis of~     mCRPC tumor, the investigators will never gain a full understanding of the biology driving~     resistance in human disease and developing rational co-targeting approaches will not be~     possible.~   "
86719|NCT02431988|"~     The purpose of this study is to administer novel cluster of differentiation antigen 19 (CD19)~     specific Chimeric Antigen Receptor T-cells (CAR19 T-cells) to patients with relapsed or~     resistant Diffuse Large B Cell Lymphoma (DLBCL) to assess the safety and efficacy of this~     strategy as a bridge to allogeneic transplantation.~   "
86720|NCT02431975|"~     The investigators propose a non-randomized clinical trial of 60 HIV-infected infants~     identified within 48 hours of birth and their mothers to investigate the consequences of very~     early ART on the establishment and maintenance of the viral reservoir.~      The first phase (early ART initiation within 48 hours of birth) will examine the trajectory~     i.e. changes over time of the viral reservoir and detection of HIV-specific antibody~     responses in infants testing HIV-positive within 48 hours of birth and initiating early ART.~      Secondary pathogenesis aims will test whether markers of neonatal immune quiescence are~     associated with the extent of seeding and rate of decline of the viral reservoir when ART is~     started at a young age and investigate whether markers in infant stool samples can be used as~     a non-invasive method of defining relevant immune and HIV-specific parameters associated with~     viral reservoir size.~      The investigators hypothesize that developmental characteristics of newborn immunity may make~     this period the optimal time to begin ART and influence the seeding of the viral reservoir.~   "
86880|NCT02429856|"~     This randomized clinical trial (RCT) examined 10 year outcomes comparing SCORPIO™ Posterior~     Cruciate Substituting (PCS) versus Posterior Cruciate Retaining (PCR) Total Knee Arthroplasty~     (TKA) as the primary outcome.~   "
86881|NCT02429843|"~     This is a single center, open-label, nonrandomized, phase 1b study of TRC105 in combination~     with standard dose treatment in patients with stage IV non-squamous non-small cell lung~     cancer.~   "
86721|NCT02431962|"~     Lung cancer is the leading cause of cancer death in North America and in the world. The vast~     majority of lung cancers are associated with cigarette smoking. Unfortunately, the majority~     of lung cancers are detected at an advanced stage when they have a very poor prognosis. A~     substantial amount of data has been reported on low-dose computed tomography (LDCT)~     screening. Yet endorsement of lung cancer screening has not been universal because of~     outstanding concerns which need to be addressed. Our study will aim to screen at risk~     Albertans for lung cancer with LDCT scan at baseline, year 1 and year 2 while attempting to~     fill some knowledge gaps on this topic.~   "
86722|NCT02431949|"~     The perception of music requires coordinated neural activities in distributed~     multi-functional centers across both hemispheres. The association between musical abilities~     and other general cognitive functions have been studied in several populations with~     inconsistent results.~      Schizophrenia is a major mental disorder that is strongly associated with cognitive deficits.~     These often appear before the onset of psychotic symptoms and persist throughout effective~     treatment of positive and negative symptoms. Like other disorders of psychosis, schizophrenia~     features general deficits in auditory memory and sensory processing. Recently, Sawada et al.~     (2014) and Wen et al. (2014) studied music abilities in Japanese and Chinese schizophrenic~     populations. They both used a standardized assessment for amusia called Montreal Battery of~     Evaluation of Amusia (MBEA) and found marked impairments in perception of scale, contour,~     interval, rhythm, meter and memory. Both studies showed that deficits in music perception~     were associated with cognitive deficits and negative symptoms. In regards to positive~     symptoms, Wen et al., but not Sawada et al., found a significant association.~      The present clinical study will assess musical abilities using the MBEA in a Canadian~     population with and without refractory psychosis. It will explore associations between~     musical deficits, positive and negative psychiatric symptomology and cognition. The patient~     population will have a diagnosis of schizophrenia, schizoaffective disorder, affective~     disorder with psychosis or non substance-related psychosis who were referred to the British~     Columbia Psychosis Program (BCPP) due to inadequate or no response to at least two trials of~     antipsychotics. A focus on refractory psychosis may provide greater insights because these~     patients have relatively more pronounced psychiatric symptoms and cognitive deficits. It will~     also be valuable to administer the MBEA assessment on a Canadian population, because the test~     was originally intended for Western populations and its musical phrases were designed with~     Western tonalities.~   "
86723|NCT02431936|"~     High blood pressure, or hypertension, is a serious problem in the African-American (AA)~     population which affects nearly 7 of every 10 AAs in our area. Previously the investigators~     showed that a significant number of AAs held onto or retained salt during mental stress~     (sodium retainers). The investigators believe that the increased salt load and resulting~     blood pressure load contributes to the eventual development of hypertension in these~     individuals. The purpose of this study is to find out if this response is due to the direct~     stimulation of the kidney (the organ that controls salt levels in the body, by the brain). To~     do this, the investigators will determine if a drug that stops the connection between the~     brain and the kidney during mental stress will prevent sodium retention in sodium retainers.~     Prazosin is an alpha adrenergic receptor blocker that has been approved by the Food and Drug~     Administration (FDA). None of the subjects who participate in this study have high blood~     pressure. The subjects will not know which testing week is the drug week and which is the~     placebo week.~   "
86724|NCT02431923|"~     Background:~      - Ebola is a lethal disease. A lot is still unknown about Ebola and its long-term effects.~     Researchers want to learn what ill health conditions Ebola survivors have. They want to learn~     if Ebola survivors can infect others in their household through close contact. They also want~     to learn if Ebola survivors are immune from getting Ebola again. To learn these things, they~     want to follow people in Liberia for 5 years.~      Objectives:~      - To learn how Ebola affects the health of survivors and the people they live with.~      Eligibility:~      - People in Liberia who had Ebola in the past 2 years, who share a household with someone who~     had Ebola, or who got ill and went to an Ebola Treatment Unit but were sent home because they~     did not have Ebola.~      Design:~        -  Participants will be screened with family illness history, physical exam, and blood~          tests. They may have an eye exam.~        -  Ebola survivors and those who went to a Treatment Unit but did not have Ebola will visit~          a clinic at 3, 6, and 12 months, then every 6 months for 5 years. At each visit, they~          will repeat the screening tests.~        -  Participants who live with someone who had Ebola will have only the screening visit. But~          they may be asked to return for follow-up visits. These visits will help researchers~          learn more about the differences between those who have had Ebola and those who have~          not.~        -  Participants brought to the NIH Clinical Center will have documentation of positive~          Ebola virus PCR and a clinical syndrome compatible with acute EVD.~        -  The study will last 5 years.~   "
86725|NCT02431910|"~     The purpose of this study is analyze the immediate and late effects of the application of KT~     in neuromuscular performance of the quadriceps in postural balance and function of the lower~     limb of healthy subjects.~   "
86726|NCT02431897|"~     This study randomizes postmenopausal women with symptomatic pelvic organ prolapse planning~     native tissue transvaginal surgical repair to 6-8 weeks of preoperative and 1-year continued~     postoperative vaginal estrogen cream compared to placebo cream. This clinical trial and basic~     science investigation are designed to understand the mechanisms by which local estrogen~     treatment affects connective tissues of the pelvic floor and determine whether its use before~     and after prolapse repair will (i) improve success rates of the surgical intervention and~     minimize prolapse recurrence and (ii) impact favorably upon symptoms of other pelvic floor~     disorders.~   "
86727|NCT02431884|"~     The purpose of this study is to collect a portion of blood/tissue specimens that will be~     generated during the participants office visit or surgery. The investigators are asking~     whether a small portion of the specimen/s could be set aside and banked for future research~     purposes. Data originating from participants will be gathered and analyzed in research~     studies that will help understanding various medical conditions such as polycystic ovary~     syndrome (PCOS), congenital uterine malformations, endocrine malfunctions, endometriosis, and~     infertility.~   "
86728|NCT02431871|"~     The aim of this study is to assess long term effects of developmental dysplasia of the hip~     (DDH) to overall health and quality of life later in life. We compare hip radiographs, hip~     symptoms, clinical examination, head asymmetry, dental examination and intraoral scans of 170~     children and young adults treated for DDH in their childhood with age and sex matched~     controls.~   "
86729|NCT02431858|"~     To randomize 108 patients undergoing knee replacement surgery to catheter through needle or~     catheter over needle femoral nerve blocks, then monitor the catheters for leakage to see if~     there is a difference.~   "
86730|NCT02431845|"~     The purpose of this study is to determine whether pharmacogenetic study predict selective~     serotonin reuptake inhibitor (SSRI) responsiveness in advance before the appearance of the~     drug effect until 4 months(16 weeks), 6 months, and 1 year after administration of SSRIs.~   "
86732|NCT02431819|"~     Elastic compression stockings are recommended in the treatment venous insufficiency.~     Degressive compressive stockings have been used for many decades and are characterized by a~     high pressure applied at the ankle and a decreasing pressure from the ankle to the knee.~     Progressive compressive stockings were developed to have a maximal pressure at the calf. This~     concept is based on the calf pump role in the venous return. Patients with PAD (Peripheral~     Arterial Disease) often suffer from venous insufficiency. But elastic compression stockings~     are strictly contraindicated for patients with PAD because highest pressures on ankle could~     slow down the superficial microcirculation.~      On patients with PAD and venous insufficiency, the progressive compressive stockings could be~     well indicated. Strongest pressure at the calf should increase the pump effect and the muscle~     mechanical efficiency during the walk without deleterious effect.~   "
86733|NCT02431806|"~     The purpose of this study is to evaluate the efficacy, safety, and tolerability of~     levomilnacipran ER relative to placebo in adolescent outpatients (12-17 years) with Major~     Depressive Disorder (MDD). In addition, the study is designed to obtain pharmacokinetics (PK)~     data to guide dose selection for future pediatric studies of levomilnacipran.~   "
86734|NCT02431793|"~     The purpose of this study is to test the effectiveness of an electronic health record based~     strategy in promoting safe use of opioid medications after an Emergency Department visit. The~     EHR-based strategy was designed to enhance provider counseling about opioids and to~     standardize and simplify the information that patients receive.~   "
86735|NCT02431780|"~     The ANSeR Clinical Investigation is a multi-centre, randomised, controlled, clinical~     investigation of a standalone decision support Algorithm for Neonatal Seizure Recognition,~     the ANSER Software system.~   "
86736|NCT02431767|"~     The study will evaluate the safety and tolerability of the PENNVAX®-GP HIV-1 DNA vaccine and~     interleukin 12 (IL-12) DNA adjuvant, given by intradermal (ID) or intramuscular (IM)~     injection with electroporation (EP), in healthy, HIV-uninfected adults.~   "
86737|NCT02431754|"~     The main purpose of this study is to evaluate the safety and efficacy of the study drug known~     as tadalafil in participants with benign prostatic hyperplasia who are being treated with an~     alpha1 blocker. This study has two treatment periods. Participants will receive tadalafil or~     placebo in each treatment period.~   "
86738|NCT02431741|"~     This is a prospective, open, non-controlled clinical investigation to evaluate the~     performance and safety of using Mepilex Transfer Ag on a malignant wound. Approximately ten~     to fifteen (10-15) subjects from one to three centers in Europe, presenting with a malignant~     (fungating) wound will be enrolled into the study. Eligible subjects will have one malignant~     (fungating) wound selected as a study site. Subjects will be followed for a one-week~     observation period with their existing product followed by a 4-week investigation period~     using Mepilex Transfer Ag.~   "
86739|NCT02431728|"~     Individuals recovering from drug and/or alcohol addiction initially experience the symptoms~     of acute withdrawal before experiencing the symptoms of post-acute withdrawal (PAWS). PAWS~     include a wide array of emotional and psychological symptoms such as anxiety, sleep~     disturbances, depression, and stress. Previous studies have shown that melatonin therapy was~     beneficial to alleviate anxiety, depressive symptoms, and sleep disturbances. However, no~     randomized, double-blind, placebo controlled trials have been conducted in males who are~     experiencing PAWS. The purpose of this study is to investigate the effect of 5 mg melatonin~     given nightly for four weeks on weekly assessed, self-reported anxiety, depressive symptoms,~     insomnia, and stress in males with PAWS who reside in a residential treatment center.~   "
86740|NCT02431715|"~     Neuroendocrine tumours (NETs) are a group of neoplasms generally arising from the~     gastroenteropancreatic tract. They are usually slow growing, have low malignant potential,~     and often go unnoticed until they become metastatic. The correct treatment approach is~     dependent on the extent of the disease, however surgical approaches and systemic therapy can~     be curative.~      Combined positron emission tomography/computed tomography (PET/CT) using the radiotracer~     18F-6-L-fluorodihydroxyphenylalanine (18F-FDOPA) has been shown to be a promising~     non-invasive technique to help localizing NETs and guide their treatment.~   "
86741|NCT02431702|"~     The purpose of the study is to compare effectiveness of paliperidone palmitate (PP:~     paliperidone palmitate once-monthly and 3-month injections) versus oral antipsychotic (OAP~     [that is oral paliperidone extended release {ER}, oral risperidone, or another OAP]) in~     delaying time to treatment failure. The study will also evaluate changes in cognition,~     functioning, brain intracortical myelin (ICM) volume following treatment with PP compared~     with OAP in participants with recent-onset schizophrenia or schizophreniform disorder.~   "
86742|NCT02431689|"~     Poor ovarian response indicates inadequate ovarian response to ovarian stimulation. In the~     current study the investigators will attempt to compare antagonist and short protocols~     regarding oocyte as well as embryo quantity and quality. Frozen embryo transfer will be~     performed in order to abolish iatrogenic effect of stimulation drugs on implantation. Still~     implantation and pregnancy rates are considered secondary outcomes.~   "
86743|NCT02431676|"~     This is a prospective, single-center randomized trial with three arms, and an allocation~     ratio of 1:1:1. The study design is an efficacy study to evaluate the effect of metformin and~     coach-directed behavioral weight loss versus self-directed weight loss on IGF-1 and IGF-1 to~     THE IGFBP-III ratio blood levels after 6 and 12 months of intervention. The coach-directed~     Behavioral Weight Loss arm is a web-based remote delivery and communication system that~     promotes healthy behavioral changes. The Metformin arm is a pharmaceutical intervention of~     oral metformin. This is a secondary prevention study for men and women who have survived~     solid malignant tumors~   "
86744|NCT02431663|"~     To evaluate the efficacy of intravenous administration of ketamine in the treatment of~     refractory convulsive status epilepticus in children compared to administration of midazolam~     at high doses, thiopental and / or propofol.~   "
86796|NCT02430987|"~     OBJECTIVE: To evaluate the prevalence of metabolic syndrome in postmenopausal women with a~     diagnosis of Hypoactive Sexual Desire Disorder. CASUISTIC AND METHODS: This is a case-control~     study in postmenopausal women attend in Menopause Clinic of the Faculty of Medical Sciences~     of Santa Casa de São Paulo. The investigators will select women diagnosed with HSDD. All~     women will sign the Consentment term. Those selected will assess the prevalence of MS through~     the ATPIII criteria. Sexual function are assessed by questionnaire Female Sexual Function~     Index (FSFI). RESULTS: The investigators hope there is greater prevalence of MS in women~     after menopause with HSDD.~   "
86745|NCT02431650|"~     This is a single-centre, controlled, open label study using P. falciparum-induced blood stage~     malaria (IBSM) infection to assess the effectiveness of OZ439 as a gametocytocidal agent, as~     well as its treatment effects on gametocyte infectivity and development in vector mosquitoes.~     Previous clinical studies including one IBSM study have shown that in addition to effectively~     clearing replicating, asexual (pathogenic) life cycle stages of malaria, a single dose of~     piperaquine (480 mg) results in the production of gametocytes, as determined by~     gametocyte-specific transcript (pfs25) qPCR. The propensity of piperaquine to induce~     gametocytaemia will be employed in this study to assess the efficacy of OZ439 as a~     gametocytocidal and transmission blocking agent. Experimental mosquito feeding via both~     direct feeding on participants and artificial (indirect) membrane mosquito feeding will be~     performed. The study will be conducted in up to 3 cohorts where participants will be~     randomised into an experimental or a control group (n=2 per group) when peak gametocytemia~     occurs (approximately 15 days after administration of piperaquine).~   "
86746|NCT02431637|"~     This is a single-centre, open-label study using P. falciparum-induced blood stage malaria~     (IBSM) infection to assess the infectivity of sexual life cycle stages of the malaria~     parasite (gametocytes) to mosquito vectors. Previous clinical studies have shown that~     treatment of participants with the antimalarial drug piperaquine, in addition to effectively~     clearing asexual (pathogenic) stages of the malaria life cycle, induces the production of~     gametocytes in the blood. The propensity of piperaquine to induce gametocytemia will be~     employed in this study to assess gametocyte infectivity to Anopheles mosquitoes. For this~     purpose, experimental mosquito feeding directly on participants and artificial membrane~     mosquito feeding will be performed. The study will be conducted in 3 cohorts (n=2 per~     cohort). Subsequent cohorts will not commence until at least after day 28 of the previous~     cohort and review by Safety Review Team. This interval will also allow cohorting of~     experimental infection of mosquitoes to optimise logistics and enable iterative improvements~     in the system if applicable.~   "
86747|NCT02431624|"~     The purpose of this study is to assess the adhesion of BTDS patch 40 µg/h.~   "
86748|NCT02431611|"~     Phase 3 Pilot Clinical Trial.~   "
86749|NCT02431598|"~     The purpose of this study is to evaluate changes in volunteer breath-holding capacity in~     response to gadoxetate disodium (Eovist) administration, compared with saline, and gadoterate~     dimeglumine (Dotarem). Healthy volunteers will be recruited from three study sites. These~     subjects will be given three, blinded, randomized injections while undergoing an MRI of their~     liver and holding their breath. During the scan, the subjects' oxygen saturation and heart~     rate will be closely monitored. Following the scan, the subjects will complete a~     questionnaire regarding the breath hold.~   "
86750|NCT02431585|"~     Recently a new clinical entity, gluten sensitivity (GS), a form of gluten intolerance in~     which neither allergic nor autoimmune mechanisms can be identified, has been added to the~     spectrum of gluten-related disorders. This condition is characterized by gastrointestinal and~     extra-intestinal symptoms including abdominal pain (68%); eczema or rash (40%); headache~     (35%); diarrhoea (33%) and fatigue (33%). The small intestine of GS patient is usually~     normal. The prevalence of GS is not yet established although it is estimated that up to 6% of~     the general population might be affected. GS has been described only in adults and no data~     are available for the paediatric population.The main problem with this new condition is that,~     at present, there are no speciﬁc biomarkers to conﬁrm GS diagnosis. In the absence of a~     serological or histological marker, the diagnosis remains clinical. In order to avoid placebo~     effect of the dietary treatment, presently GS diagnosis needs to performed with double-blind~     randomized placebo-controlled challenge provided that both wheat allergy and CD have~     previously been excluded.~      The primary aim of the study is to evaluate the prevalence of GS in IBS paediatric patients.~      The secondary aims are: 1) to describe clinical, serologic, genetic and histological profile~     of GS patient and 2) to study the role of gluten or other possible wheat components in the~     onset of GS.~      Study design Randomized double blind placebo controlled cross over re-challenge trial.~     Patient consecutively diagnosed as having IBS (Rome III criteria) in whom the diagnosis of~     coeliac disease and wheat allergy has been excluded, will be considered eligible for the~     study.~      Diagnosis of coeliac disease and wheat allergy will be excluded by the negativity of TTG-IgA~     and/or EMA and of Skin Prick Test, RAST immuno-CAP and Atopy patch test respectively.~      Patients will entered a three-phase study with a running in phase (phase I: weeks 1-2),~     diagnostic elimination diet phase (phase II: week 3-4) and re-challenge phase (phase III:~     week 5-12)~   "
86751|NCT02431572|"~     This research study is studying the changes in primary and metastatic brain tumor~     inflammation using positron emission tomography (PET) imaging using a radioactive substance~     called [11C] PBR28a, which is also known as peripheral benzodiazepine receptors (PBR), or~     PBR-PET.~   "
86752|NCT02431559|"~     This is an open-label, non‐randomized, multicenter Phase 1/2 study of MEDI4736 in subjects~     with recurrent, platinum-resistant ovarian cancer, scheduled to receive Pegylated Liposomal~     Doxorubicin (PLD). Subjects will be treated during each 28-day cycle according to the~     treatment schedule.~   "
86753|NCT02431546|"~     The purpose of this study is to understand the effects of a mobile health cardiovascular~     prevention program in patients who have recently graduated from cardiac rehabilitation. The~     mobile health program will focus on promoting healthy lifestyles through the use of a mobile~     application (app), mobile physical activity monitor and a system of remote health coaching.~      By testing a novel mHealth intervention focused on lifestyle modification, this trial will~     address a critical evidence gap in the care of patients after they graduate from CR. Many~     patients who graduate from traditional CR struggle with unhealthy lifestyles, and these~     patients currently have no lifestyle-based care strategies to help them. The results of this~     study have the potential to lead to new sustainable and resource-efficient, lifestyle-based~     preventive care strategies for patients with stable CVD.~   "
86754|NCT02431533|"~     IBS is a disorder of movement in the gut. People who have IBS may have diarrhea,~     constipation, or alternating bouts of both. IBS is not caused by injury or illness. Often the~     only way doctors can diagnose it is to rule out other conditions through testing.~   "
86755|NCT02431520|"~     A study to investigate the compliance of unassisted women to self-collection of specimens for~     Hybrid Capture (HC) for detection of Human Papilloma Virus (HPV) DNA compared to Pap smear~     collection by medical personnel, as screening method to identify precursor lesions of~     cervical cancer.~   "
86756|NCT02431507|"~     The purpose of this study is to determine the safety and feasibility of the Magnap magnetic~     device in the treatment of obstructive sleep apnea (OSA).~   "
86797|NCT02430974|"~     Epidermal growth factor receptor (EGFR) mutations occur in up to 50% of Asian patients with~     non-small cell lung cancer (NSCLC). Treatment of advanced NSCLC patients with EGFR-tyrosine~     kinase inhibitors (EGFR-TKI) confers a significant survival benefit. This study assessed the~     efficacy and safety of chemotherapy with or without icotinib in patients undergoing resection~     of stage IB to IIIA EGFR-mutated NSCLC.~   "
86757|NCT02431494|"~     Acne vulgaris is a multifactorial, highly prevalent dermatologic condition that results in~     visible lesions that can be quite disfiguring. Consequently, individuals with acne often~     suffer from a wide range of psychological manifestations. Although there is consensus that~     combination therapy is most effective in treating acne, researchers are constantly striving~     to develop new treatment. Microcurrent therapy (MCT) is a non-invasive modality that has~     successfully been used to promote wound healing and has been routinely used in aesthetics.~     Use of MCT alone or in combination with current successful treatment such as blue light~     phototherapy (BLP), may hold promise for acne treatment. The investigators propose to conduct~     a small randomized control trial to determine the safety and preliminary efficacy of a novel~     combination therapy to treat acne vulgaris. The investigators will recruit up to 60 males and~     females and randomly assign them to one of 3 arms: 1) BLP; 2) MCT; and combination therapy~     (BLP and MCT). The investigators will assess physiological parameters (number of acne~     lesions, amount of sebum produced, degree of acne severity) and psychosocial factors~     (dermatologic quality of life, social anxiety, depressive symptomatology, self-esteem).~     Participants will complete a baseline assessment prior to initiating treatment and a~     follow-up assessment at 4 weeks post termination of treatment. The investigators will conduct~     intermediary assessments at weeks 3 and 5 and 1 week post termination of the treatment. The~     investigators will use measures of central tendency to describe the sample and repeated~     measures analysis of variance to compute the main and interaction effects.~   "
86758|NCT02431481|"~     The purpose of this study is to characterize the PK and safety profile of LEE011 following a~     single oral dose in adult subjects with various degrees of renal impairment compared to a~     matched group of healthy subjects with normal renal function.~   "
86759|NCT02431468|"~     This is a randomized double-blind placebo-controlled study comparing different doses of~     bryostatin for the treatment of moderately severe to severe Alzheimer's disease. The study is~     15 weeks in duration, including a safety and efficacy evaluation 30 days after the last dose~     of study drug.~   "
86760|NCT02431455|"~     This study evaluates the omission of incentive spirometry use following bariatric surgery.~     Half of participants will receive an incentive spirometer while the other half will not.~     Oxygen saturation and pulmonary complications after surgery will be measured to examine the~     effectiveness of incentive spirometry.~   "
86761|NCT02431442|"~     The purpose of this study is to evaluate the multiple dose safety and tolerability of RM-493~     (setmelanotide) as well as pharmacokinetic (PK) and pharmacodynamic (PD; weight loss)~     profile, in healthy obese patients for 2 to 4 weeks. In addition, one panel of patients with~     a specific genetic deficiency in the hypothalamic leptin- proopiomelanocortin (POMC) -~     melanocortin-4 receptor (MC4R) pathway, those with heterozygous partial or full loss of~     function (LOF) of the MC4R gene, will also be studied. The study drug (RM-493 and placebo)~     will be administered subcutaneously in a blinded fashion by subcutaneous (SC) infusion or~     injection.~   "
86762|NCT02431429|"~     This study is a Phase 4, open-label, single group study in which at least 55 evaluable adult~     male patients undergoing miltefosine treatment for mucocutaneous leishmaniasis will provide~     semen samples for spermiogram analysis of sperm parameters.~   "
86763|NCT02431416|"~     The purposes of the study is to investigate whether circulating levels of ghrelin decreases~     after an iv injection of GnRH in girls with suspected central premature puberty and to~     investigate the effects of different post sampling handling on the preservation of acylated~     ghrelin.~   "
86764|NCT02431403|"~     Open-labeled, multicenter, phase I/II study of imatinib combined with ESHAP as salvage~     therapy in relapsed/refractory non-Hodgkin's lymphoma~   "
86765|NCT02431390|"~     This study is to investigate whether the RAPAELⓇ Smart Glove digital treatment system~     improves the upper extremity function of stroke patients compared to other clinical treatment~     by measuring serial behavioral and neuroimaging assessments and to find out therapeutic~     effect or adverse effect and patient's feed back responses~   "
86766|NCT02431377|"~     A single center, non-controlled trial to document the gastrointestinal (GI) tolerability of~     the study formula (SF), containing a whey protein concentrate enriched with alpha-lactalbumin~     (WPC alpha-lac) fed for 6 weeks to healthy, term infants.~   "
86767|NCT02431364|"~     This is a randomized, double-blind, sequential, dose-escalation, Phase 1 trial to evaluate~     the safety and tolerability of verdinexor. Verdinexor or placebo will be given on days 1 and~     3 to healthy adult subjects.~   "
86768|NCT02431351|"~     This is an open-label study designed to evaluate the safety and efficacy of the selective~     inhibitor of nuclear export (SINE) compound, Selinexor given orally to patients with~     transfusion-dependent, EPO-refractory lower-risk MDS (Low risk and Intermediate-1 as defined~     by IPSS).~   "
86769|NCT02431338|"~     The aim of this study is to investigate the cost-effectiveness of remote ischemic~     conditioning as an adjunct to primary percutaneous coronary intervention from the perspective~     of a Danish healthcare system.~   "
86770|NCT02431325|"~     The purpose of this research study is to determine whether teduglutide can repair a leaky~     gut, decrease inflammation, and prevent or treat plaque, a build-up of fat and other~     materials in the blood vessels of the heart, in people with HIV. HIV disease is linked to~     inflammatory changes and leakiness of the gut. These changes or conditions may increase the~     risk of developing heart and blood vessel disease. The investigators believe teduglutide can~     help repair the gut barrier in people with HIV, leading to a decrease in inflammation and~     plaque in the blood vessels of the heart.~   "
86771|NCT02431312|"~     This is an open-label study to evaluate the safety, tolerability, and immunogenicity of dose~     combinations of INO-1800 (DNA plasmids encoding HBsAg and HBcAg) and INO-9112 (DNA plasmid~     encoding human interleukin 12) delivered by electroporation (EP) in 90 (ninety) nucleos(t)ide~     analogue treated patients.~   "
86810|NCT02430805|"~     This project aims at investigating the genetic, genomic and proteomic basis of hypertension~     and susceptibility to hypertension-related end organ damage (renal damage and heart failure).~     It will include cross sectional as well as follow-up studies with a large number of subjects~     and variety of phenotypes, to explore the pathophysiology of hypertension and~     hypertension-related disease.~   "
86882|NCT02429830|"~     The purpose of this study is to evaluate the LINX device in patients who have previously~     undergone laparoscopic sleeve gastrectomy (LSG) for obesity and have chronic gastroesophageal~     reflux disease (GERD). The study will monitor safety and changes in reflux symptoms.~   "
86772|NCT02431299|"~     Illness Management and Recovery (IMR) is an evidenced-based approach to teaching consumers~     with severe mental illness how to set and achieve personal recovery goals and acquire the~     knowledge and skills to independently manage their illnesses. Longitudinal, multi-site, and~     randomized controlled trials have shown IMR to be effective in increasing illness~     self-management and coping; some evidence also points to reduced hospitalization rates.~     Fidelity, or adherence to a specific treatment model, is equally important to both clinical~     research and to the practical dissemination of evidence-based practices to the field.~      To this end, the research team has developed an IMR clinician-level fidelity assessment, the~     IMR Treatment Integrity Scale (IT-IS). However, the validity of the preliminary IT-IS has not~     been rigorously evaluated. Additionally, it is crucial to develop strategies to utilize the~     IT IS to increase adherence to the IMR model and ultimately increase consumer outcomes.~      The purpose of this study is to assess the construct validity of the IT-IS by testing the~     relationship between IT-IS elements and mechanisms of change and proximal outcomes. The~     investigators will collect a sample of IMR session recordings and pre-post data from IMR~     participants from recruitment sites in Indiana, New Jersey and several other states. The~     investigators will test hypothesized relationships between specific program elements and~     theoretically proposed mechanisms of change. The investigators will also assess~     organizational and clinician factors affecting IMR competence by including a survey for the~     staff members who are located as sites where the investigators have clinicians participating~     in providing IMR.~   "
86773|NCT02431286|"~     The objective of this study is to investigate if aprepitant in association with palonosetron~     and dexamethasone could reduce the incidence of PONV in high-risk patients for this symptom,~     undergoing cancer surgery mastectomies.~   "
86774|NCT02431273|"~     This study will evaluate the hypothesis that intravaginal rings (IVRs) can safely and in a~     sustained fashion, deliver the antiretroviral (ARV) drugs - tenofovir disoproxil fumarate~     (TDF), emtricitabine (FTC), and maraviroc (MVC), in healthy women when used in the following~     drug combinations: 1) TDF (Single IVR); 2) TDF-FTC (Dual IVR) and; 3) TDF-FTC-MVC~     (Triple IVR).~   "
86775|NCT02431260|"~     This is a study of INCB054329 given to patients with advanced malignancies that will be~     conducted in three treatment groups. Each treatment group will have three parts; a dose~     escalation (Part 1), an intra-patient dose titration (Part 2), and an expansion (Part 3).~   "
86776|NCT02431247|"~     The purpose of this study is to demonstrate non-inferiority in efficacy of a~     darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed dose combination~     (FDC) tablet versus Darunavir/Cobicistat (DRV/COBI) FDC coadministered with~     Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) FDC in human immunodeficiency virus-1~     (HIV-1) infected, antiretroviral (ARV) treatment naive adult participants.~   "
86777|NCT02431234|"~     The blood concentration of the protein RANKL could be predictive of the calcification of the~     leg arteries, which is a major complication occurring during diabetes. The objective of the~     DIACART study is to show that blood RANKL concentration predict the progression of~     calcification of the leg arteries in diabetic patients, independently of other cardiovascular~     risk factors.~   "
86778|NCT02431221|"~     A Study on the Efficacy, Safety, and Tolerability of Perhexiline maleate in Subjects with~     Hypertrophic Cardiomyopathy and Moderate-To-Severe Heart Failure~   "
86779|NCT02431208|"~     This multicenter, open-label, Phase I study will evaluate the safety, efficacy, and~     pharmacokinetics of atezolizumab alone or in combination with daratumumab and/or various~     immunomodulatory agents in participants with MM who have relapsed or who have undergone~     autologous stem cell transplantation (ASCT). The planned duration of this study is~     approximately 36 months. Cycle length will be 21 days in Cohorts A to C and 28 days in~     Cohorts D to F.~   "
86780|NCT02431195|"~     The main objective of this study is to identify changes in eating behaviors and physical~     activity in patients after bariatric surgery and their family members living in same~     household: children aged between 11-17 years, spouse, parents, cohabitee or partner in a~     civil union.~   "
86781|NCT02431182|"~     Randomized controlled trial to assess the effectiveness of a Memory Training Workshop in~     cognitive function, in terms of self-perceived memory, everyday memory and executive control~     abilities. It is expected that the group intervention of memory training that this study~     proposes significantly improves cognition (memory, attention and executive control abilities)~     and the quality of life related to health (HRQOL) in the Experimental Group (EG) compared to~     the Control Group (CG). The group of individuals that take part in the Memory Training~     Workshops (Experimental Group) will be compared to another group of similar characteristics~     that do not (Control Group). Data will be collected at baseline, 3 months later and 6 months~     later.~   "
86782|NCT02431169|"~     The investigators propose to conduct a pilot feasibility study of single agent erlotinib in~     patients with metastatic EGFR mutant adenocarcinoma of the lung with up to one prior~     treatment with the sole purpose of characterizing the genomic landscape before erlotinib and~     at the time of disease progression. The logistics of obtaining adequate quality fresh tissue~     specimens for sequencing studies before therapy and at the time of disease progression in~     patients with advanced lung cancer are complex and a thorough understanding of the practical~     challenges in conducting a study like this is crucial.~      The current proposal will include exome and transcriptome sequencing from blood collected at~     baseline along with tumor samples obtained prior to starting erlotinib and at the time of~     disease progression (a total of two tissue samples and one blood sample per patient). If~     carried out successfully, the proposed strategy very likely will lead to a larger and~     adequately powered study to understand fully evolving molecular changes due to clonal~     selection under treatment pressure. The pace of progress in the field of sequencing~     technology currently underway is only likely to accelerate in the near future yielding richer~     and highly content-rich information. Moreover, it is likely that genomic information from DNA~     sequencing and transcriptome will be supplemented by analyses of translatomes and proteomes.~      The investigators plan to sequence paired tumor specimens from 20 patients with EGFR mutant~     adenocarcinoma of the lung before treatment with erlotinib and at the time of disease~     progression following treatment with erlotinib. As the investigators expect some drop off~     (due to unexpected clinical events precluding a second biopsy at the time of disease~     progression, poor specimen quality and early discontinuation of therapy for non-progression),~     the investigators will enroll 40 patients in this trial to get 20-paired specimens.~   "
86783|NCT02431156|"~     Patients who underwent mini-monovision (with bilateral myopic defocus, MM-BMD) surgery for~     presbyopia correction with monofocal intraocular lenses implantation are supposed to have~     sufficient uncorrected vision capacity for activities of daily living (ADLs) that require: a)~     distant vision(DV), (ie. driving), b) intermediate vision (IV), (ie. computer word~     processing), c) near vision (NV), (ie. book reading). Primary objectives of the study are: 1)~     the development of a series of tasks in a research setting that will simulate common ADLs~     that require DV, IV, and NV. 2) the identification of potential correlations of the tasks in~     the research setting with demographic, clinical and other parameters of the study~     participants.~   "
86784|NCT02431143|"~     This is a multicenter, non-comparative, open-label clinical trial to assess the~     Pharmacokinetics (PK) and safety of miltefosine using an allometric dose algorithm in the~     treatment of children with primary Visceral Leishmaniasis (VL) in eastern Africa. Efficacy~     and Pharmacodynamics (PD) will be assessed as secondary outcomes.~      The proposed study aims to assess whether drug exposure in children can be increased to~     equivalent adult drug exposure by using the miltefosine allometric dose given BID for 28 days~     in paediatric VL patients aged 4-12y and whether this dose is tolerable. The present study is~     also expected to provide the basis for minimum time to reach sufficient drug exposure for~     miltefosine activity to guide optimal treatment duration to be used in combination therapy~     for visceral leishmaniasis. The PK data will be assessed in this trial using a compartmental~     population PK approach.~   "
86785|NCT02431130|"~     The goal of this study is to examine whether low‐fidelity instructor‐driven simulation can~     provide effective teaching of anesthetists' non‐technical skills in a developing world~     context. Human factors, such as communication, planning, and team working are considered~     nontechnical skills which contribute greatly to patient safety in complex hazardous systems~     such as aviation, nuclear power industry, and operating rooms. Simulation began in the~     aviation industry to train pilots in human factors. In the past two decades simulation has~     been valued in medical education as it allows the learner to rehearse skills in an~     environment that is similar to the workplace but without the threat of harm to patients. High~     Fidelity simulators involve computer driven interactive mannequins that recreate an authentic~     environment. This has been used successfully to teach anesthetists' non‐technical skills~     (ANTS) such as: decision making, team working, task management, and situation awareness.~     Anesthetists' non‐technical skills are particularly important in developing countries where~     the shortage of supplies, equipment, and qualified personnel can lead to a perilous working~     environment making team work and communication vital for patient safety. The costs of high~     fidelity simulation are prohibitive for many developing countries. This study seeks to~     examine whether low fidelity instructor driven simulation can provide an effective~     intervention to teach anesthetists' non‐technical skills in Rwanda. If found to be effective,~     this method of training could be applied to other developing countries to improve~     non‐technical skills for anesthesia providers with the goal of making surgery safer.~   "
86786|NCT02431117|"~     To evaluate the suitability (i.e. number of tests completed and number of participants~     completing the tests, variance estimate of baseline and of the change from baseline values)~     of neurocognitive tests and functioning scales in view of their use in future multicenter,~     multinational clinical efficacy trials testing a putative cognitive enhancer for individuals~     with Down syndrome aged 6-30.~   "
86787|NCT02431104|"~     A single-center prospective, open-label, uncontrolled study in 10 male or female subjects,~     age 18 to 65 years, who desire laser removal of a tattoo which contains all black ink.~   "
86788|NCT02431091|"~     The purpose of this study is to determine the sensitivity and specificity of the use of~     optical coherence tomography to detect HIV-associated neurocognitive disorder compared to MRI~     and usual cognitive screening tools.~   "
86789|NCT02431078|"~     The aim of this study was to investigate the expression of ZEB1 in CTCs for gastric cancer,~     its correlation with the clinicopathology of gastric cancer, and the role of ZEB1 in invasion~     and metastasis in gastric cancer.~   "
86790|NCT02431065|"~     Rectus sheath block is effective in reducing pain in the peri-umbilical region, and the use~     of ultrasonography is recommended to perform the block at the precise location. Recently,~     intra-operative rectus sheath block has also been introduced without the aid of~     ultrasonography. However, no study has not yet compared the analgesic effects of these two~     different approaches (ultrasonography-guided vs direct surgical). Thus, the aim of our study~     is to compare the effect of ultrasonography-guided and direct-surgical rectus sheath block~     after single-port access laparoscopy in benign ovary cyst patients.~   "
86791|NCT02431052|"~     The objectives of this study are to assess the safety and efficacy DRM01 Topical Gel compared~     to vehicle in patients with acne vulgaris.~   "
86792|NCT02431039|"~     This study is to investigate whether NEOSORB Plus antibacterial suture (chlorhexidine~     diacetate coated PGLA910) is not inferior to NEOSORB suture (PGLA910) in the points of~     intraoperative handling.~   "
86793|NCT02431026|"~     The American Heart Association (AHA) recommends cooling (inducing mild hypothermia) patients~     who were resuscitated following cardiac arrest but who remained comatose. Induced mild~     hypothermia is now the standard of care for post-resuscitation patients in the intensive care~     unit (ICU) setting. The use of cooling has recently moved to pre-hospital and emergency~     department (ED) application as more current studies show that early initiation of cooling~     significantly improves neurologic outcomes and survival rates instead of waiting until the~     patient arrives in the ICU to initiate cooling. In the pre-hospital setting chilled saline~     (4°C) and packing the body in ice have been the primary methods to initiate induced mild~     hypothermia The Excel Cryo Cooling System is a non-invasive cervical collar (C-collar) that~     provides cooling to the carotid arteries, the main blood supply to the brain, and allows for~     the rapid initiation of selective cerebral cooling. The investigators are planning to use~     MRI-thermometry to see how quickly the Excel Cryo Cooling Collar can drop brain temperature~     when applied by itself.~      Healthy volunteers will be used for this study to provide important temperature data on the~     effectiveness of the Excel Cryo Cooling System. The investigators will be able to use the~     data from this project to further the current clinical research in induced mild hypothermia~     after cardiac arrest.~   "
86794|NCT02431013|"~     This is a randomized, open-label, single & multiple-dose, parallel study to investigate the~     effect of cilostazol on the disposition of simvastatin & pravastatin in healthy male~     volunteers~   "
86795|NCT02431000|"~     PURPOSE: Primary objective: To assess the feasibility and outcomes of male fertility~     preservation by sperm freezing prior to starting treatment requiring alkylating agents and/or~     total body irradiation.~      Secondary objective: To assess pre- and post-treatment sperm production and hormonal status~     by measurement of serum anti-mullerian hormone (AMH), inhibin-B, follicle stimulating hormone~     (FSH), luteinizing hormone (LH), testosterone, and androstendione.~   "
86854|NCT02430194|"~     An Open-label, Dose-ranging Study to Evaluate the Safety and Efficacy of Lonafarnib With~     Ritonavir Boosting in Patients Chronically Infected With Delta Hepatitis (HDV) (LOWR-2).~   "
86798|NCT02430961|"~     Donation after Cardiac Death (DCD) is an increasingly common mechanism through wish patients~     can donate tissue and organs following death after withdrawal of life sustaining therapies~     (WLST). Unfortunately many potential DCD donors are not ultimately able to donate and this is~     a significant emotional and resource burden to families, healthcare workers and hospitals. A~     tool that allows accurate prediction of time to death following WLST (and thus the~     probability of successful donation) is urgently needed. Existing models have not been useful~     due to the lack of generalizability. Additionally, existing models have not included other~     important factors now recognized to be associated with time to death following WLST.~      The investigators will conduct a prospective, observational cohort study of all patients~     being considered for DCD in whom consent for donation is obtained to evaluate the association~     between neurologic and non-neurologic risk factors for apnea, other clinically important~     variables and time to death after WLST, and use these data to derive a generalizable~     predictive model for the prediction of the time to death following WLST in potential DCD~     donors.~   "
86799|NCT02430948|"~     The study hypothesis is that clearer visual presentation of guideline recommendations and~     educational outreach, or academic detailing, can improve guideline compliance. However, it~     will investigate other aspects of screening-related decision-making, such as provider and~     patient beliefs about screening, provider-patient communication and patient's willingness to~     forgo expected testing. The research question is whether educational interventions can~     decrease non-compliance with screening guidelines for 5 common cancers.~   "
86800|NCT02430935|"~     The proposed study will involve a randomized trial of Cognitive Adaptation Training (CAT) for~     early intervention as compared against an active control in which Action Based Cognitive~     Remediation (ABCR) will be applied.~   "
86801|NCT02430922|"~     The objective of this clinical investigation is to evaluate the short-term (up to 12 months)~     outcome of treatment by means of the self-expanding iVolution nitinol stent in symptomatic~     (Rutherford 2-4) femoropopliteal arterial stenotic or occlusive lesions.~   "
86802|NCT02430909|"~     The purpose of this study is to evaluate the safety, efficacy and body distribution of~     Bimekizumab (UCB4940) when added to Certolizumab Pegol treatment in patients with Rheumatoid~     Arthritis. Neither the patient nor the doctor will know the treatment group.~   "
86803|NCT02430896|"~     The objective of this study is to identification of neuropsychological, genetic and~     neuroimaging markers and treatment response predictors of attention-deficit/hyperactivity~     disorder (ADHD). Participants who take the standardized pharmacotherapy (methylphenidate or~     atomoxetine) for ADHD will be observed for 52 weeks. They will do several neuropsychological,~     neuroimaging and genetic tests at visit 1~6.~   "
86804|NCT02430883|"~     We want to serach the relationship between the pain degree and stone localisation in kidney~     in Retrograde intrarenal surgery~   "
86805|NCT02430870|"~     This is a phase 1, randomized, double-blind, placebo-controlled, 2-center, multiple-dose~     study in healthy participants and participants with type 2 diabetes mellitus (T2DM). This~     study will evaluate the safety, tolerability and pharmacokinetics (PK) of TAK-648 when~     administered as multiple oral doses of TAK-648 solution at escalating dose levels in healthy~     participants of Japanese decent and participants with T2DM.~   "
86806|NCT02430857|"~     This study evaluates the effectiveness of stimulating the neurological segments c8-th5 in~     patients with latent hypothyroidism.~      One half of the participants will receive an osteopathic manuel treatment in order to~     stimulate the relevant segments, the other half will receive no treatment.~   "
86807|NCT02430844|"~     Title: Role of biomarkers in predicting contrast-induced acute kidney injury in critically~     ill patients: a prospective observational study~      Objective: To analyse the role of plasma and urinary biomarkers (Neutrophil~     Gelatinase-Associated Lipocalin (NGAL), Cystatin C and Kidney Injury Molecule-1) in~     predicting contrast-induced acute kidney injury (CI-AKI) in critically ill patients.~      Summary of the project:~      Acute deterioration of renal function after intravenous administration of radiocontrast~     media, i.e. increase in serum creatinine concentration of more than 0.5 mg/dl or 25% above~     baseline within 48 hours, is referred to as contrast-induced kidney injury (CI-AKI). The~     increasing number of diagnostic procedures requiring radiographic contrast has parallel~     increase in the incidence of CI-AKI. CI-AKI is described as the third most common cause of~     new AKI in hospitalized patients. Occurrence of CI-AKI is reported up to 55% in high risk~     patients like presence pre-existing chronic renal dysfunction, diabetes, hypertension,~     chronic heart failure, advanced age, volume depletion, uses of concurrent nephrotoxic~     medication. These risk factors for CI-AKI are common in critically ill patients. Recently,~     different urinary and serum proteins have been intensively investigated as possible~     biomarkers for the early diagnosis of AKI, which includes Neutrophil Gelatinase-Associated~     Lipocalin (NGAL), Cystatin C and Kidney Injury Molecule-1 (KIM 1). At present, there is~     scarcity of prospective study on CI-AKI and role of biomarkers in critically ill medical or~     medical-surgical mixed ICU patients.~      The investigators plan to enroll about 100 ICU patients during 2 years, requiring computed~     tomography (CT) scans with parenteral administration of iodinated radiographic contrast for~     any diagnostic purposes as decided by the clinicians during the treatment of the patients. In~     this prospective observation study, the investigators want to analyse the role of plasma and~     urinary biomarkers in predicting CI-AKI in critically ill patients.~      Key Words: acute kidney injury, radiographic contrast, critically ill, biomarker~   "
86808|NCT02430831|"~     Study type:~      Randomized controlled trial with two parallel arms Objectives~      Primary : Demonstrate that daily supplementation of colicky infants with Nidina formula~     containing L. reuteri DSM 17938 decreases the daily crying duration at 21 days Secondary :~     Evaluate the effects of daily supplementation of colicky infants with Nidina formula~     containing L. reuteri DSM 17938 measured as~        1. the number of responders or the treatment success (ie infants for which defined as~          the percentage of children achieving a reduction in the daily average crying time >50%~          in 3 weeks. (day 1 to day 21 of the study)~        2. maternal depression and family functioning scoring~   "
86809|NCT02430818|"~     Opioid pain medications such as morphine and dilaudid are commonly used in emergency~     departments to treat pain in patients. Physicians are familiar with the side effects of these~     medications; the most concerning of which is slowing or stopping a patient's breathing, as~     well as dangerously lowering their blood pressure. An alternative medication is ketamine.~     This medication is also commonly used in the emergency department, although it is typically~     used to help sedate patients for uncomfortable procedures. Ketamine has also been used for~     pain control, but in a much lower dosage that does not sedate patients. When used for~     analgesia, it has typically been administered in combination with opioid pain medications. To~     date, there is no study that looks at the effectiveness and safety of using a low dose~     ketamine alone in comparison to the use of morphine. The purpose of this study is to measure~     how well low-dose ketamine treats pain compared to morphine and to look at how often serious~     side effects are seen with each medication.~   "
86855|NCT02430181|"~     To Evaluate the Safety and Efficacy of Lonafarnib with and without Ritonavir Boosting in~     Adults With Genotype 1 Chronic Hepatitis D Virus (HDV) Infection (LOWR-1).~   "
86811|NCT02430792|"~     Prostate cancer is the most common malignancy in men. Three million are currently living in~     the United States with the disease and this number is expected to rise to four million in~     2024. Most live many years with the disease and experience significant morbidity both due to~     disease progression and treatment toxicity. Exercise has shown to improve QoL and reduce~     treatment toxicity. Moreover epidemiological evidence has suggested that physical activity~     improves survival.~      Football has been shown to induce positive effects on body composition and bone markers in a~     subgroup of prostate cancer patients, those receiving androgen deprivation therapy.~      The objective is to examine the effectiveness of football in prostate cancer survivors.~   "
86812|NCT02430779|"~     The purpose of this study is to evaluate the safety and efficacy of irreversible~     electroporation (IRE) for unresectable Renal Pelvic and Ureteral Neoplasms.~   "
86813|NCT02430766|"~     The purpose of this study is to evaluate the safety and efficacy of irreversible~     electroporation (IRE) for unresectable Lymph Node Metastases.~   "
86814|NCT02430753|"~     The purpose of this study is to evaluate the safety and efficacy of irreversible~     electroporation (IRE) for Lung Neoplasms accompanied by Respiratory Function Insufficiency.~   "
86815|NCT02430740|"~     The study objective is to develop a tailored based strategy for ovarian stimulation in IVF~     patients using AMH, BMI, antral follicle count (AFC).~      300 patients will be randomized in 2 arms:~        1. control group: standard care rec FSH.~        2. study group: modified dose of Rec FSH based on AFC with a correction factor based on BMI~          and basal AMH level.~      Primary endpoints: number of mature follicles and eggs collected at egg retrieval; amount of~     rec FSH used.~      Secondary endpoints: fertilization rate; cleavage rate; clinical pregnancy rate; inhibin B~     and AMH levels during ovarian stimulation.~   "
86816|NCT02430714|"~     This study is a post-marketing surveillance of lenvatinib in participants with unresectable~     thyroid cancer. The objectives of this study are to capture unknown adverse reactions,~     incidences of adverse drug reaction, efficacy, factors considered to have effect to safety~     and effectiveness, and incidences of hypertension, hemorrhagic events and thromboembolic~     event, and liver disorder.~   "
86817|NCT02430701|"~     The purpose of this study is to evaluate the safety and efficacy of irreversible~     electroporation (IRE) for unresectable Esophageal Neoplasms.~   "
86818|NCT02430688|"~     The purpose of this study is to evaluate the safety and efficacy of irreversible~     electroporation (IRE) for unresectable Extremities Neoplasms.~   "
86819|NCT02430675|"~     The purpose of this study is to evaluate the safety and efficacy of irreversible~     electroporation (IRE) for unresectable Laryngeal Neoplasms.~   "
86820|NCT02430662|"~     The purpose of this study is to evaluate the safety and efficacy of irreversible~     electroporation (IRE) for unresectable Gallbladder Neoplasms.~   "
86821|NCT02430649|"~     The purpose of this study is to evaluate the safety and efficacy of irreversible~     electroporation (IRE) for unresectable Prostatic Neoplasms.~   "
86822|NCT02430636|"~     The purpose of this study is to evaluate the safety and efficacy of irreversible~     electroporation (IRE) for unresectable Stomach Neoplasms.~   "
86823|NCT02430623|"~     The purpose of this study is to evaluate the safety and efficacy of irreversible~     electroporation (IRE) for unresectable Urinary Bladder Neoplasms.~   "
86824|NCT02430610|"~     The purpose of this study is to evaluate the safety and efficacy of irreversible~     electroporation (IRE) for unresectable Uterine Cervical Neoplasms.~   "
86825|NCT02430597|"~     The purpose of this study is to evaluate the safety and efficacy of irreversible~     electroporation (IRE) for Hilus Pumonis Neoplasms.~   "
86826|NCT02430584|"~     To obtain whole blood specimens from pregnant subjects to be used for research and~     development and clinical validation studies of prenatal assays.~   "
86827|NCT02430571|"~     This is a prospective, single-center, open label, within-subject clinical trial to evaluate~     the identification of anatomical markers in the gastrointestinal tract using the IRIS feeding~     tube. The trial will evaluate hospitalized subjects who require short-term enteral feeding~     with an anticipated duration of at least 3 days while in an intensive care unit (ICU) or~     step-down unit. Eligible men and women at least 18 years of age who give voluntary, written~     informed consent to participate in the clinical investigation will be included as subjects.~     If a potential subject is incapacitated and unable to provide informed consent, a designated~     legally authorized representative will be allowed to provide the informed consent on behalf~     of the subject to allow their participation in the study. Study entry will be defined as the~     point of signed informed consent. A Prospective, Single-Center, Open Label, Within-Subject~     Case Series to Evaluate the Identification of Anatomical Markers in the Gastrointestinal~     Tract Using the KANGAROO™ Feeding Tube with IRIS Technology~   "
86828|NCT02430558|"~     Patient with IKDC score < 65, pretreated with mosaicplasty or ACI ( with matrix or not)~     within > 18 months, with one or two osteochondral lesions are recruited to have treated~     osteochondral allografts in mosaicplasty.~   "
86829|NCT02430545|"~     The study also aims to determine the effect of a strong enzyme (CYP3A4) inducer-rifampin- on~     drug exposure of Glasdegib. This study will be conducted in healthy subjects given a single~     dose of glasdegib in each period.~   "
86830|NCT02430532|"~     The primary objective of the study is to investigate whether treatment with BG00012 (dimethyl~     fumarate) compared with placebo slows the accumulation of disability not related to relapses~     in participants with secondary progressive multiple sclerosis (SPMS). The secondary objective~     of the study is to assess the effect of BG00012 compared with placebo on patient-reported~     outcomes, brain atrophy, and cognitive function.~   "
86831|NCT02430519|"~     Background: Furcation is the bifurcation or trifurcation of a multirooted tooth. It is an~     area of complex anatomic morphology difficult to debride by routine periodontal~     instrumentation. Multiple approaches have been used in an effort to treat the furcation~     Choukroun's platelet-rich fibrin (PRF), a second generation platelet concentrate has~     biochemical components which have well known synergetic effects on healing processes. The~     present study was conducted to evaluate the effectiveness of autologous platelet-rich fibrin~     (PRF) in the treatment of mandibular molar Grade 2 furcation defects in comparison to~     allograft and guided tissue regeneration (GTR) membrane.~   "
86856|NCT02430168|"~     Purpose: to investigate the postoperative outcomes of Retrograde intrarenal surgery versus~     percutaneous nephrolithotomy in 2 to 4 cm kidney stones.~   "
86832|NCT02430506|"~     The available live tuberculosis vaccine Bacillus Calmette-Guérin (BCG) provides incomplete~     protection against pulmonary tuberculosis. For unknown reasons, a BCG revaccination or~     booster, while not toxic, does not provide much additional protection. AERAS-402 presents~     tuberculosis antigens in the setting of a new, live, replication deficient adenovirus vaccine~     that may increase T cell immunity and thus protection from tuberculosis. Since BCG-vaccinated~     individuals are the population for which AERAS-402 might be indicated, AERAS-402 will be~     administered to individuals in Kenya who have already been vaccinated with BCG.~   "
86833|NCT02430493|"~     The primary objective is to describe the safety and tolerability of ticagrelor, by assessment~     of adverse events (characteristics, reporting rate, severity, relationship and risk factors),~     especially the bleeding events as defined in 8.1 and other serious adverse events (SAEs)~     during 1-year follow up in Chinese acute coronary syndrome (ACS) patients.~   "
86834|NCT02430480|"~     Background:~        -  There are several ways to treat prostate cancer. Researchers want to see how well a~          certain kind of imaging helps detect prostate cancer. They also want to see if a~          particular drug combination used before surgery will benefit people with prostate cancer~          that hasn t spread in the body (non-metastatic). The combination will be androgen~          deprivation therapy and enzalutamide.~        -  The combination of androgen deprivation therapy and enzalutamide has been shown to make~          patients with advanced (metastatic disease) live longer. The investigators want to see~          if using it earlier can increase cure rate of surgery and identify genetic or molecular~          characteristics that are associated with better outcomes.~      Objectives:~      - To develop better ways of detecting prostate cancer before and after pre-operative~     treatment.~      Eligibility:~      - Men at least 18 years old with non-metastatic prostate cancer. They must be candidates for~     a radical prostatectomy.~      Design:~        -  Participants will be screened with medical history, physical exam, and blood tests. They~          will have scans and X-rays.~        -  Before starting the study drugs, participants will have:~        -  Vital signs taken, medical history, and blood tests.~        -  ECG heart test, with patches stuck on the skin.~        -  Small piece of tumor removed (biopsy) using image guidance from MRI and ultrasound.~        -  3T mpMRI. Participants will lie on a table that slides into a metal cylinder. A probe~          will be inserted in the <TAB>rectum. They will be in the scanner for about 60 minutes,~          lying still. The scanner makes loud knocking <TAB>sounds. Participants will get~          earplugs.~        -  Participants will take the 2 study drugs for 6 months.~        -  Enzalutamide is taken as 4 pills once a day.~        -  Androgen deprivation therapy is given by injection 2 times over 6 months.~        -  During these 6 months, participants will visit the clinic monthly. They will have~          physical exam, vital signs, and blood drawn.~        -  After finishing the study drugs, participants will have another 3T mpMRI. Then they will~          have prostate removal surgery.~   "
86835|NCT02430467|"~     The purpose of this study is to develop more effective ways to help patients and their~     caregivers cope with cancer pain. The investigators are looking at the usefulness of a~     Caregiver-Guided Pain Management Training Intervention versus Pain Education.~   "
86836|NCT02430454|"~     Decisions about ICU beds allocations are made everyday, specially in countries with scarcity~     of ICU beds, such as Brazil. ICU triage, most of the time, is not structured, which may lead~     to faulty decision making, possibly leading to bad clinical outcomes. It has been shown that~     external factors may influence the decision making process. The investigators intend to~     evaluate the impact of bed availability and cognitive load on the ICU bed allocation process~     by submitting groups of individuals to a vignette based randomized controlled trial~     simulating conditions with or without increased cognitive load and conditions with or without~     scarcity of ICU beds.~   "
86837|NCT02430428|"~     The objective of this clinical trial is to evaluate the safety and effectiveness of the Carl~     Zeiss Meditec VisuMax™ Femtosecond Laser lenticule removal procedure for the reduction or~     elimination of myopia from ≥ -1.00 D to ≤ -10.00 D with ≤ -3.00 D cylinder (myopia with or~     without astigmatism) and MRSE ≤ -11.50 D.~   "
86838|NCT02430415|"~     The aim of the study is to compare the effect of the laryngoscope-assisted lightwand~     intubation technique vs. the conventional lightwand intubation technique on the cervical~     spine motion during intubation in patients with the simulated cervical immobilization.~   "
86839|NCT02430402|"~     Young patients with rheumatic diseases have challenges different from older patients due to~     their life situation. It has been reported that they do not have the same benefit from age~     non-specific rehabilitation in warm climate. This trial will test the effect of a specially~     adapted version of a rehabilitation program delivered in Spain (warm climate) for Norwegian~     young adults aged 20-35 years.~   "
86840|NCT02430389|"~     To identify a better method using a combination of routine anesthetic drugs to improve~     hemodynamic stability during Mayfield head pinning for craniotomy surgery.~   "
86841|NCT02430376|"~     Background:~      Pentalogy of Cantrell (POC) is a syndrome that involves many heart abnormalities as well as~     large defects in the chest and abdominal wall. This often results in the heart and other~     organs being present outside the body at birth. Surgeons have learned to replace them and~     repair the heart. Researchers want to find possible gene changes that cause POC. To do this,~     they want to study data from the Pediatric Cardiovascular Genetics Consortium (PCGC) Cohort.~     The PCGC collects data and DNA samples from people with heart diseases and their families~      Objectives:~      - To find gene mutations in people with Pentalogy of Cantrell (POC) or other related~     syndromes.~      Eligibility:~      - PCGC data and DNA samples that are open to study by the public.~      Design:~        -  Researchers will study the data from the PCGC.~        -  The gene testing being done in this study was consented to in the original studies. No~          new consent or waiver request is required.~        -  The study will last 1 year.~   "
86842|NCT02430363|"~     It is known that after application of MK-3475 activated PD -1 negatively regulates the~     activation of T cells through suppression of the path of PI3K / Akt.~      This study will identify the effectiveness of oral inhibitors of PI3K / Akt pathway in~     comparison with MK-3475 (pembrolizumab).~   "
86843|NCT02430350|"~     The primary objective of the study is to confirm the efficacy of compound Edaravone Injection~     via intravenous infusion every 12 hours in the patients with Acute Ischemic Stroke(AIS) in a~     double-blind, active-controlled manner. The study is also to examine the safety of compound~     Edaravone Injection for the AIS patients.~   "
86844|NCT02430337|"~     In this study, a computer-assisted adaptation of SafeCare, an evidence-based home visiting~     program, will be developed and tested in child welfare. This approach will assist home~     visitors with delivery of SafeCare to families, with the goal of improving provider fidelity~     and implementation success. In the computer-assisted SafeCare sessions, a portion of the~     session will be delivered on a tablet computer that the home visitor brings to the family's~     home. The computer software will deliver the educational piece, or explain piece of each~     session, along with modeling videos of the skills. The home visitor will follow up with the~     practice and feedback portions of the session. A randomized feasibility trial will be~     conducted to test the technology-based approach against the standard SafeCare implementation~     approach in terms of feasibility of implementation, provider job demands and resources, as~     well as client outcomes such as skill acquisition and mental health.~   "
86845|NCT02430324|"~     Traumatic brain injury (TBI) is a leading cause of death and disability worldwide (Ghajar,~     2000). With an estimated annual incidence of up to 500 per 100,000 population and more than~     200 hospital admissions per 100,000 admissions in Europe each year, TBI is a major challenge~     to public health (Lingsma, 2010). Mortality and morbidity after TBI depend on several~     factors, either associated with patients characteristics, the cause of TBI, the neurological~     and general severity and secondary brain insults, the structural brain alterations as~     diagnosed at brain computed tomography (CT) (Rosenfeld, 2012).~      The prognostic value of brain CT characteristics is well documented, including the status of~     basal cisterns, midline shift, the presence and type of intracranial lesions, and traumatic~     subarachnoid hemorrhage (Maas, 2008). Postraumatic cerebral ischemia, which includes~     functionally impaired yet still viable tissue, so-called ischemic penumbra, and irreversible~     cerebral infarction (PTCI), is frequent in patients who die after moderate or severe head~     trauma (Stocchetti, 2014).~      Evidence of antemortem occurrence of PTCI is limited to three single-center retrospective~     studies, reporting a varying prevalence of 1.9%, 8% and 19.1% (Mirvis, 1990; Marino, 2006;~     Tawil, 2008). Increased intracranial pressure (ICP), blunt cerebral vascular injury, need for~     craniotomy and treatment with recombinant activated factor VII, have been demonstrated to be~     risk factors for PTCI. In one study, PTCI was an independent risk factor for poor outcome~     after moderate or severe head trauma with a two-fold increase in mortality and severe~     disability (Marino, 2006).~      PTCI can be an important diagnosis in patients with significant TBI for various reasons.~     First, it might influence long-term outcome. Second, as an outcome that is measurable, and~     relevant to survival and lifestyle, PTCI could be used as an outcome measure in randomized~     controlled trials. Third, diagnosis of PTCI could be used as a standard diagnostic reference~     to validate early surrogate indicators of cerebral ischemia.~      The investigators therefore planned a multi-center prospective study to investigate the~     impact of PTCI on disability at hospital discharge, and on 6-month morbidity and mortality in~     a population of moderate and severe adult TBI patients. The investigators also evaluated the~     role of intracranial hypertension, decreased cerebral perfusion pressure, hypotension and~     other secondary ischemic insults in determining the appearance of PTCI.~   "
86846|NCT02430311|"~     This is a 2 parts phase I, open label trial of olaparib monotherapy and olaparib in~     combination with paclitaxel in patients with solid tumours. Part A will assess the single and~     multiple dose pharmacokinetics of olaparib monotherapy and multiple dose pharmacokinetics of~     olaparib in combination with paclitaxel. Part B will assess the safety of multiple doses of~     olaparib in Cohort 1 and of olaparib when co-administered with paclitaxel in Cohort 2~   "
86847|NCT02430298|"~     The study evaluates the effect of melatonin for preventing concurrent radiochemotherapy~     induced oral mucositis and xerostomia and improving quality of life in head and neck cancer~     patients. This is a randomized, double-blind, placebo controlled trial conducted in head and~     neck cancer patients. Mixed-block randomization is used to divide eligible patients into two~     groups: melatonin 40 mg or matched placebo. The patients are required to take the studied~     drugs 20 mg suspensions before radiation and 20 mg capsules at night (after 21.00 pm) on the~     first night of radiation and continue for 7 weeks. Standard treatment is Radiation 2 Gy 5~     fraction/week not more than 7 weeks with Cisplatin chemotherapy base regimen according to~     standard hospital protocol. Study endpoints are level of mucositis (CTCAE scale, WHO scale~     and MTS scores), level of xerostomia (CTCAE scale, VAS), QOL (FACT-H&N), pain (VAS 0-10) and~     adverse event frequency.~   "
86848|NCT02430285|"~     Acute biliary pancreatitis (ABP) is a potentially life-threatening condition caused by common~     bile duct (CBD) stones or sludge, which requires prompt diagnosis and treatment by endoscopic~     removal of the material. Accurate detection of CBD stones is warranted to select patients for~     early therapeutic endoscopic retrograde cholangiopancreatography (ERCP).~      In clinical practice the decision to perform an ERCP is often based on biochemical and~     radiological criteria despite they already have been shown to be unreliable predictors of CBD~     stone presence.~      Endoscopic ultrasound (EUS) is not currently a worldwide standard diagnostic procedure early~     in the course of acute biliary pancreatitis, but it has been shown to be accurate, safe and~     cost effective in diagnosing biliary obstructions compared with magnetic resonance~     cholangiopancreatography (MRCP) and ERCP and therefore in preventing unnecessary ERCP and its~     related complications.~      The investigators aim to investigate the clinical usefulness of early EUS in the management~     of ABP.~      All consecutive patients entering the emergency department due to acute abdominal pain and~     showing biochemical and/or radiological findings consistent with possible ABP will be~     prospectively enrolled. Patients will be classified as having a low, moderate, or high~     probability of CBD stones, according to established risk stratification. All enrolled~     patients will undergo EUS within 48 h of their admission. ERCP will be performed immediately~     after EUS only in those cases with proven CBD stones or sludge.~      The following parameters will be investigated: (1) clinical: age, sex, fever; (2)~     radiological: dilated CBD, (3) biochemical: bilirubin, aspartate aminotransferase (AST),~     alanine aminotransferase (ALT), gamma glutamyl transferase (gGT), alkaline phosphatase (ALP),~     amylase, lipases, C-reactive protein (CRP). Association between presence of CBD stone at EUS~     and the individual predictors were assessed by univariate logistic regression. Predictors~     significantly associated with CBD stones (p<0.05) will enter in a multivariate logistic~     regression model.~   "
86849|NCT02430272|"~     Anticholinergic drugs have traditionally been used for their antisialagogue properties. But~     use of anticholinergic drugs can interfere with thermoregulation via inhibition of the~     parasympathetically mediated sweat secretion. Sweating inhibition can reduce heat~     elimination, and children's thermoregulation depend more on sweating than adults and they can~     become hyperthermic when given these agents.~      The investigators evaluated the fever-causing effects of adjunctive anticholinergics in~     children under general anesthesia using ketamine.~   "
86850|NCT02430259|"~     Tuberculosis (TB) remains the most important infectious disease in the world. Preventive~     treatment plays an important role in successful control of TB. For preventive therapy, the~     three-month (12-dose) regimen of weekly rifapentine and isoniazid (3RPT/INH) are now~     recommended by WHO for its non-inferiority, safety and convenience compared with 6~9 months~     regimen of daily isoniazid monotherapy or 3~4 months daily rifampicin monotherapy. And the~     treatment completion rate is higher compared with daily regimen. However, relevant study is~     lacking in China where the TB burden is high with the incidence rate of 70/100, 000. And the~     provision of chemoprophylaxis is not recommended in China currently.~      Silicosis is a high risk factor of Mycobacterium tuberculosis infection. This is an~     open-label, randomized, Phase III clinical trial to evaluate the effectiveness and~     tolerability of the 3RPT/INH to prevent tuberculosis (TB) compared with those who do not~     receive preventive treatment among silicotic patients.~   "
86851|NCT02430246|"~     Pregnant women at high risk for preterm labor from at least 13 weeks of gestation will be~     tested to detect abnormal vaginal flora (AVF) or its severe form - bacterial vaginosis (BV)~     by taking vaginal smear. Treatment will be given according to the results.~   "
86852|NCT02430233|"~     Patients diagnosed with arrested pre-term labor following tocolytics at 24-34 gestational~     weeks will be randomly allocated to receive either vaginal micronized progesterone 400 mg/day~     or no treatment.~   "
86853|NCT02430207|"~     Temporary pacing via femoral vein is used widely in mainland China, because of its~     feasibility and simplicity. However, pulmonary embolism often occurred after the procedure.~     It is not known that whether there was any difference in incidence of pulmonary embolism~     between via different approaches. This randomized and multi-center study was designed to~     verify whether temporary pacing via subclavian vein has lower incidence than via femoral~     vein.~   "
86857|NCT02430155|"~     Postpartum hemorrhage (PPH) is responsible for around 25% of maternal mortality worldwide~     reaching as high as 60% in some countries.PPH can also be a cause of long-term severe~     morbidity, and approximately 12% of women who survive PPH will have severe anemia.~      Postpartum hemorrhage has been defined as blood loss in excess of 500 ml in a vaginal birth~     and in excess of 1 L in a cesarean delivery.For clinical purposes, any blood loss that has~     the potential to produce hemodynamic instability should be considered a PPH. However,~     clinical estimates of blood loss are often inaccurate. Primary (immediate) PPH occurs within~     the first 24 hours after delivery and approximately 70% of these cases are due to uterine~     atony. Furthermore, uterine tony is defined as the failure of the uterus to contract~     adequately after the child is born.~      Guidelines for the management of postpartum hemorrhage (PPH) involve a stepwise approach~     including the exclusion of retained products of conception and genital tract trauma. Uterine~     atony, which is the most common cause, the management of uterine atony is an established~     stepwise protocol that in many international guidelines.~      Uterine massage is recommended for the treatment of PPH. Initiate uterine massages soon as~     excessive bleeding/uterine atony is identified. Intravenous oxytocin alone still is the~     recommended uterotonic drug for the treatment of PPH.~      If intravenous oxytocin is unavailable or if the bleeding does not respond to oxytocin,~     intravenous ergometrine, oxytocin-ergometrine fixed dose or a prostaglandin drug (including~     sublingual misoprostol, 600 mcg) should be given. The use of intrauterine balloon tamponade~     is recommended for the treatment of primary PPH due to uterine atony in women who do not~     respond to uterotonics or if uterotonics are not available.~      Since 1983, when Goldrath published evidence that inserting a Foley catheter in the uterus~     and inflating it with water could achieve tamponade, case series and other studies have~     suggested that various uterine balloon tamponade(UBT) devices may be effective in treating~     PPH. The studies used various types of UBT devices, including a condom catheter, a Foley~     catheter, the Sengstaken-Blakemore Esophageal Tube, the Rusch Balloon, and the Bakri Uterine~     Balloon. In 2007, a systematic review of treatment options for PPH found that 84% success~     rate of UBT does not significantly vary from surgical treatment outcomes.The World Health~     Organization (WHO), the International Federation of Gynecology and Obstetrics (FIGO), the~     American College of Obstetricians and Gynecologists(ACOG), the Royal College of Obstetricians~     and Gynecologists(RCOG), and the International Confederation of Midwives (ICM) recognize~     balloon tamponade as a method that could significantly improve the management intractable~     PPH, especially in low-resource areas.~      In 2012, WHO updated the guidelines for the management of PPH and retained placenta to~     include: The use of intrauterine balloon tamponade is recommended for the treatment of PPH~     due to uterine atony. This recommendation is now stronger than the previous guidelines. It~     can be used for women who do not respond to uterotonics or if uterotonics are not available.~     This procedure potentially can avoid surgery and is appropriate while awaiting transfer to a~     higher-level facility.Furthermore, FIGO included UBT as a recommended second-line~     intervention for the treatment of PPH in their updated guidelines issued in 2012.~      Bakri first published the concept of intrauterine balloon technology in the management of~     hemorrhage secondary to placenta praevia-accreta during caesarean section with or without~     bilateral hypo gastric arterial ligation.In 2006, the ACOG Practice Bulletin, published by~     the American College of Obstetricians and Gynecologists, made mention of the Bakri postpartum~     balloon for its specifically tailored design that enables conservative management of uterine~     bleeding in cases of uterine atony and other causes of PPH.~      The idea of using a condom as a balloon tamponade was first generated and evaluated in~     Bangladesh by Sayeba Akhter to fill a need and in response to the high cost of commercially~     available UBT devices.~   "
86859|NCT02430129|"~     This study is a randomized controlled trial comparing total knee arthroplasty (TKA) to~     unicompartmental knee arthroplasty (UKA) in patients with no to moderate anteromedial knee~     osteoarthritis. TKA patients will receive the Zimmer Persona (Warsaw, IN) posterior cruciate~     retaining total knee arthroplasty, while UKA patients will receive the Biomet Oxford (Warsaw,~     IN) mobile bearing unicompartmental knee arthroplasty.~      Outcome measures will include Western Ontario and McMaster University Osteoarthritis Index~     (WOMAC) and Oxford Knee Score (OKS) questionnaires, as well as biomechanics and EMG analysis~     from the investigating gait lab.~      The investigators hypothesize that post-operative UKA patients will display higher clinical~     scores using WOMAC and OKS questionnaires, and superior biomechanical analysis measures. The~     investigators further hypothesize that the biomechanics data will assist in the understanding~     of the outcome score differential both pre- and post-operatively in both groups, as well as~     between-groups.~      Total follow up period will be two years.~   "
86860|NCT02430116|"~     Background: The cardiomyocytes apoptosis induced by ischemia-reperfusion(I/R) is one of the~     most important factors in the myocardial I/R injury(MIRI) undergoing cardiac valve~     replacement with cardiopulmonary bypass(CVRCPB),and Ischemic postconditioning (I-postC) can~     inhibit apoptosis of myocardial cells. Consequently, this study investigated the key genes~     and apoptosis signaling pathways of myocardium in patients undergoing CVRCPB.~      Methods: A total of 36 New York Heart Association class II or III patients with rheumatic~     heart disease (RHD) of both sexes, aged 21-59 years, who were scheduled for first cardiac~     valve replacement with CPB in the investigators' hospital from February 2014 to May 2015,~     were randomly divided into the following three groups (n=12 each): negative control group~     (NEG group); I/R group (POS group); and I-postC group (Treat group). In the Treat group, the~     procedure involved 5 min before opening the ascending aorta, aortic unclamping for 30 s, and~     cross-clamping for 30 s for three cycles, after which the ascending aorta was completely~     opened. The NEG and Treat groups were not treated. Thirty-six patients were assessed for~     arrhythmia and recovery of myocardial contractile function after reperfusion by~     electrocardiograms and degree of dependence on vasoactive drugs. The myocardial tissues of~     the right atrial appendage were obtained at 3 min before CPB was established in the NEG~     group, and at 45 min after opening the aorta in the POS and Treat groups. In all three~     groups, the myocardial tissues of the right atrial appendage were obtained and preserved at~     −80°C for further experiments. The right atrial appendage of three patients randomly selected~     in each group was fixed with RNA later (Qiagen, Hilden, Germany) in a centrifuge tube~     overnight at 4°C, and then preserved at −20°C for RNA extraction. Human 12×135K Gene Array~     profiling of mRNA expressions was undertaken in human cardiac muscle cells. Differentially~     expressed mRNAs verified by quantitative real-time RT-PCR were subjected to pathway analysis.~     The mRNA expressions of AIF, APAF1, CYCS, Bax, caspase-3, caspase-9, caspase-6, caspase-7,~     BCL2, BAG1, and PI3K were assessed by real-time RT-PCR and western blot analysis. The levels~     of myocardial apoptosis induced by I/R were investigated by TUNEL assays. The changes in MIRI~     induced by myocardial apoptosis were investigated by pathologic examination of the~     myocardium.~   "
86861|NCT02430103|"~     The purpose of this study is to assess efficacy of gonadotropin-releasing hormone agonist~     (goserelin) on the preservation of ovarian reserve function in breast cancer patients of~     reproductive age treated with (neo)adjuvant chemotherapy by serial measuring the biochemical~     marker AMH pre and post chemotherapy~   "
86862|NCT02430090|"~     45 pregnant women undergoing cesarean section were enrolled in the study in november 2006 to~     march 2007. 2 ml of 0.5% levobupivacaine was added to 1 ml of saline in group I, 1 ml of 15~     µcg of fentanyl in group II and 1 ml of 1,5 µcg sufentanil in group III by intratechal~     administration. Hemodynamic parameters, characteristics of sensory and motor blockade,~     peri-operative and postoperative visual analogue scale (VAS) pain scores, the time to the~     first analgesic requirement and adverse effects were recorded.~   "
86863|NCT02430077|"~     Lipodystrophies are rare disorders characterized by selective loss of adipose tissue and~     predisposition to insulin resistance and its metabolic complications. Hepatic steatosis is a~     common complication in patients with partial and generalized lipodystrophies.Despite~     aggressive management of diabetes and hyperlipidemia, hepatic steatosis and its complications~     present a therapeutic challenge in many patients. Due to this large disease burden, it is~     important to assess the efficacy and safety of novel therapies for hepatic steatosis in~     patients with lipodystrophies.There are, however, no systematic studies evaluating various~     therapeutic interventions for reducing hepatic steatosis in patients with lipodystrophies. A~     variety of drugs have been investigated in nonlipodystrophic patients with non-alcoholic~     hepatic steatosis and steatohepatitis (NASH) or non-alcoholic fatty liver disease (NAFLD).~     Recent data support the activation of the farnesoid X receptor (FXR, NR1H4), a nuclear~     hormone receptor regulated by bile acids, for treatment of NASH and NAFLD. FXR activates~     transcription of several genes particularly the atypical nuclear receptor small heterodimer~     partner (SHP, NR0B2) and thus can influence triglyceride metabolism within hepatocytes.Both~     cholic acid (CA) and chenodeoxycholic acid (CDCA) are ligands for FXR, however, UDCA which is~     the 7 hydroxy β-epimer of CDCA, does not activate FXR. Obeticholic acid (OCA) is a~     first-in-class selective FXR agonist which has approximately 100 fold greater FXR-agonistic~     activity in the nanomolar range, as compared to CDCA .It therefore appears that FXR~     modulation offers interesting therapeutic possibilities in treating hepatic steatosis. This~     study is primarily designed to study efficacy of OCA, a strong FXR ligand, in reducing~     hepatic triglyceride levels in patients with hepatic steatosis and Familial Partial~     Lipodystrophy (FPLD). If proven to be effective, it may reduce morbidity and mortality as a~     result of sequelae of hepatic steatosis in patients with lipodystrophies.~   "
86864|NCT02430064|"~     This study aims to investigate the effects of diets enriched or depleted in foods at high~     risk of containing pro-inflammatory bacterial molecules, on markers of inflammation and~     cardiometabolic risk in healthy men. The study design is an interventional diet study, with 7~     days dietary advice to avoid processed foods, followed by 4 days in which lunch and evening~     meal are provided to volunteers. Anthropometric and blood markers of cardiovascular disease~     risk are measured at the start and end of each dietary phase. The aim is to gain an improved~     understanding of how processed foods modify risk of cardiometabolic disease.~   "
86865|NCT02430051|"~     The goal of this project is to examine the efficacy of a sensory adapted dental environment~     (SADE) for children who have difficulty tolerating oral care in the dental clinic. The~     investigators hypothesize that adapting the sensory environment in the dental office by~     modifying the sounds, sights,and tactile experiences will result in decreased anxiety,~     increased cooperation, and fewer behavior problems for children with Autism Spectrum~     Disorders (ASD). This has the potential to contribute to increased child comfort as well as~     safer, more efficient, and less costly treatment for a large population, as potentially more~     than one-fourth of all children may benefit from a sensory adapted dental environment.~   "
86866|NCT02430038|"~     This is a prospective observational study of transperineal ultrasound between 24-42 weeks~     gestation and a prospective longitudinal observational study in all term (37-42 weeks)~     labouring women.~   "
86883|NCT02429817|"~     Vibrating-mesh nebulizers ensure currently the best deposition output and are recommended in~     routine use in intensive care unit. However, jet nebulizers remain the most frequently used~     nebulizers.~      On a bench study, aerosol delivery through a high flow nasal cannula (HFNC) was increased~     using a vibrating-mesh nebulizer as compared to a jet nebulizer.~      Lung distribution of nebulized particles delivered through a HFNC has never been investigated~     in vivo. The aim of this study was to compare aerosol lung distribution with both nebulizers~     through a HFNC by SPECT-CT.~   "
86867|NCT02430025|"~     This proposal delineates a research plan to collect blood from the patients with~     cardiovascular diseases for the purpose of establishing a molecular biological bank registry.~     The Fujian provincial hospital will enroll 8,000 patients.The blood collected will be~     processed to create a repository of molecular biological plasma. Along with a sample of blood~     collected from individual patients, a concise general medical history, demographic data,~     electrocardiographic data, echocardiographic data, and laboratory data will be collected. A~     short interview will take place after enrollment during the outpatient visit or hospital~     stay, or may be conducted via phone call after enrollment. All the clinical data gathered~     will be compiled in Fujian provincial hospital center database, and would be stored in a~     format where a culmination of clinical findings, i.e. representing a disease of interest, can~     be used to search the database to identify the blood samples of all patients with such~     characteristics for further study.~   "
86868|NCT02430012|"~     The investigators have identified underuse of secondary prevention medications at discharge~     of patients underwent coronary artery bypass grafting (CABG) in China. The aim of this study~     is to develop series of quality improvement strategies focusing on secondary prevention~     medications for patients underwent CABG, and to evaluate their effectiveness and safety via a~     hospital-level cluster randomized clinical trial. The investigators established a network of~     60 hospitals which have participated into Chinese Cardiovascular Surgery Registry and~     submitted 50 or more CABG surgeries already. The participating sites will be divided into~     intervention and control groups in a 1:1 ratio. The intervention group will undertake~     intervention of quality improvement strategies, while the control group will maintain the~     routine practice pattern. All hospitals will consecutively enroll and submit data of CABG~     during the enrollment period, estimated for 6 months. The prescribing rates of angiotensin~     converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB), beta-blockers,~     statins and aspirins will be compared between 2 groups.~   "
86869|NCT02429999|"~     Infertility in not a health problem and that infertile couples are not really ill. However,~     this narrow interpretation of the problem is refuted by the world community. The WHO defines~     health as a state of complete physical, mental and social wellbeing and not merely the~     absence of disease or infirmity. It has also been argued that overpopulation is the main~     problem in the developing countries and that helping infertile couples contradicts the~     interests of the countries and the world at large. However, this narrow approach contradicts~     human rights in general and reproductive rights in particular.~      In 1994, the United Nations International Conference on Population and Development in Cairo~     mentioned issues on future actions on 'prevention and appropriate treatment of infertility~     where feasible'. However, no guidelines or concrete actions and programmes were given for~     developing countries.~      Worldwide, more than 80 million couples suffer from infertility; the majority of this~     population are residents of developing countries.~      In September 2001, a meeting on 'Medical, Ethical and Social Aspects of Assisted~     Reproduction' was organized by the WHO. For the first time, major attention was paid to~     ongoing developments in assisted reproduction technology together with their social and~     ethical implications in developing countries . It was the first time that the WHO highlighted~     the issue of assisted reproduction in developing countries.~      ART in developed countries is highly expensive one of steps is ovulation induction the most~     common protocol for induction is the long gonadotrophin-releasing hormone (GnRH) agonist~     pituitary suppression regimen combined with relatively high doses of exogenous~     follicle-stimulating hormone (FSH) remains the most frequently used stimulation protocol~     which is expensive. in our study we will use a mild ovarian stimulating protocol letrozole~     adjuvant to gonadotrophins which is less expensive~      The use of aromatase inhibitor have only recently been introduced in infertility treatment,~     especially for ovulation induction.~      An aromatase inhibitor blocks the conversion of androgens to estrogens in the ovarian~     follicles, peripheral tissues, and in the brain. This result in two things: (a) Fall in~     circulating and local estrogens and (b) Rise in intraovarian androgens. Fall in estrogen~     levels, releases the hypothalamopituitary axis from the negative feedback of estrogens. Thus,~     there is a surge in follicle stimulating hormone (FSH) release, which results in follicular~     growth. Since, the feedback mechanism is intact; normal follicular growth, selection of~     dominant follicle, and atresia of smaller growing follicle occurs; and thereby facilitating~     monofollicular growth and ovulation.Another mechanism of action of the aromatase inhibitors~     is by the increasing intraovarian androgens. This increases the follicular sensitivity to~     FSH. Recent data shows the role of androgens in early follicular developments. by augmenting~     FSH receptors and stimulating insulin-like growth factor (IGF)-I; FSH and IGF-I act~     synergistically to promote follicular growth. This pharmacodynamics of letrozole ensures~     improved endometrial thickness, cervical mucus, monofollicular, and better folliculogenesis.~     So , these factors may lead to higher pregnancy rates and greater likelihood of singleton~     pregnancy.~      Letrozole has been tried for ovarian stimulation for assisted reproduction. With the concept~     of mild stimulation in IVF to improve implantation rate, letrozole is a potential agent.~     Letrozole has two potential uses in IVF: First, where it is used in the follicular phase~     usually with FSH/human menopausal gonadotropin (HMG) for ovulation induction; second, it has~     also been used in luteal phase of stimulated IVF cycle and to reduce circulating E2 levels;~     thus, potentially reducing ovarian hyperstimulation syndrome (OHSS) risk.~      A significant reduction in the total dose of gonadotrophins was found when aromatase~     inhibitor was added in controlled ovarian hyperstimulation (COH) cycles.~      Some studies evaluated the addition of letrozole in patients with normal ovarian response~     undergoing IVF or Intracytoplasmic sperm injection( ICSI). They showed higher implantation~     and ongoing pregnancy rates in the letrozole cotreatment group.~   "
86870|NCT02429986|"~     Adaptive Servo-Ventilation (ASV) treatment is routinely prescribed in France. In order to be~     reimbursed according to the French Social Security rules, the patient treated with an ASV~     needs to be examined each year. In this observational transversal single-visit study, the~     investigators aim to describe the clinical characteristics of patients treated with ASV and~     the associated device settings.~   "
86871|NCT02429973|"~     Multicenter and prospective phase II trial with gemcitabine and rapamycin in second line of~     metastatic osteosarcoma. The study includes 6 cycles of the combination gemcitabine+rapamycin~     in metastatic or unresectable osteosarcoma patients.~   "
86872|NCT02429960|"~     Until today there is no standard-monitoring to specifically reflect the analgesic component~     of general anesthesia. Quality and safety of general anesthesia are of major clinical~     importance and can be improved by limiting the administration of opioid analgesics to the~     minimum dose needed. This study therefore examines the quality of three different monitoring~     techniques (PhysioDoloris, MetroDoloris, Lille, France, SPI (Surgical Plethysmographic~     Index), GE Healthcare, Helsinki, Finland and AlgiScan, IDMed, Marseille, France) in assessing~     the level of analgesia during general anesthesia. Therefore a standardized painful stimulus~     is applied under different levels of analgesic drugs. The monitor's indices are compared to~     clinical signs such as an increase in heart rate and blood pressure.~   "
86873|NCT02429947|"~     The purpose of this study is to identify the issues that have greatest impact on QOL for~     patients with Charcot Marie Tooth (CMT) Disease. Patients who have -registered in the~     Inherited Neuropathies Consortium Contact Registry will be invited to participate.~   "
86874|NCT02429934|"~     This research trial is for patients who have been diagnosed with systemic lupus erythematosus~     (SLE) with swollen, tender joints (which is called inflammatory polyarthritis) because of the~     SLE.~      The purpose of this clinical research study is to evaluate the safety and effectiveness of~     treatment with abatacept (Abatacept) 125mg injected subcutaneously (under the skin) weekly~     for 16 weeks versus placebo injections(a substance with no active ingredients and therefore~     may have no treatment benefit) in subjects with SLE and inflammatory polyarthritis. The~     effectiveness will be assessed primarily by the number of swollen, tender joints (called a~     joint count) at each of study visits.~      Study Medication Abatacept is approved in the U.S. for treating rheumatoid arthritis by~     prescription and has not been approved by the U.S. Food and Drug Administration for treating~     SLE yet.~      In this study, subjects will receive treatment with either abatacept or placebo once a week~     for 16 weeks (a total of 16 injections).~   "
86875|NCT02429921|"~     About 45 million people in Bangladesh are chronically exposed to unacceptable levels of~     arsenic in their drinking water. Chronic arsenic poisoning leads to cancers, and vascular~     diseases.~      This dietary trial intends to test the potential of high-selenium lentils, consumed as lentil~     soup, in reducing the arsenic body burden in an exposed Bangladeshi population, and in~     improving the overall health status.~      Arsenic-exposed families will be assigned to one of two groups. One group will eat lentils~     (50g/person/day) that are naturally high in selenium, the other group will receive lentils~     with low selenium content. This 6 months trial is randomized and double-blinded.~   "
86876|NCT02429908|"~     This study is a post-market clinical follow-up study to fulfill the post-market surveillance~     obligations according to Medical Device Directive and MEDDEV 2.12-2_Rev2_January 2012. The~     data collected from this study will serve the purpose of confirming safety and performance of~     the TM Ardis implant. The goal of this study is to demonstrate that implant is effective in~     reducing patient disability.~   "
86877|NCT02429895|"~     A Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Active Psoriatic~     Arthritis Subjects Who Have Completed a Preceding Study M14-197 Phase 2 Randomized Controlled~     Trial (RCT).~   "
86878|NCT02429882|"~     The purpose of this study is to assess the safety and efficacy of brodalumab compared with~     placebo in participants with axial spondyloarthritis. Subjects will be randomized in a 1:1~     ratio to brodalumab or placebo for the first part of the study. Subjects will then receive~     open label brodalumab for the remainder of the study. The entire study will be 312 weeks in~     duration for each subject.~   "
86879|NCT02429869|"~     Zortress (everolimus), the 40-O-(2-hydroxyethyl)-derivative of rapamycin, is an mTOR~     inhibitor approved for rejection prophylaxis in kidney transplant recipients. mTOR inhibition~     may favorably impact the HIV viral reservoir, and we hypothesize that adding everolimus to~     the transplant immunosuppressive regimen of HIV positive transplant recipients will decrease~     HIV persistence in CD4+ lymphocytes.~   "
86884|NCT02429804|"~     This pilot clinical trial studies combined fluorine F 18 sodium fluoride (NaF)/~     fludeoxyglucose F 18 (FDG) positron emission tomography (PET) and magnetic resonance imaging~     (MRI) in measuring response to a drug, radium Ra 223 dichloride (Ra-223), in treating~     patients with prostate cancer that has not responded to hormone therapy and has spread to~     other parts of the body. Combining NaF/FDG in a simultaneous PET/MRI scan may help doctors~     accurately measure how well patients respond to treatment with radium Ra 223 dichloride.~   "
86885|NCT02429791|"~     The aim of this study is to determine if virologically suppressed human immunodeficiency~     virus type 1 (HIV-1) infected adults on an antiretroviral regimen (including 2 nucleoside~     reverse transcriptase inhibitors [NRTIs] plus a third agent) remain suppressed upon switching~     to a two-drug regimen with dolutegravir (DTG) + rilpivirine (RPV). The study will primarily~     assess the non-inferiority antiviral activity of switching to DTG + RPV once daily compared~     to continuation of current antiretroviral regimen (CAR) up to Week 48 with a switch visit for~     eligible subjects in the CAR group to initiate DTG + RPV therapy at Week 52. CAR will include~     2 NRTIs plus 1 HIV-1 integrase inhibitor (INI), or 1 non-nucleoside reverse transcriptase~     inhibitor (NNRTI), or 1 protease inhibitor (PI). The study will include a 148-week open-label~     treatment phase, comprising of an Early Switch Phase (Day 1 to Week 52) and a Late Switch~     Phase (Week 52 to Week 148). The participants fulfilling the study eligibility criteria will~     participate in the Early Switch Phase where they will either switch from their CAR to DTG +~     RPV, or continue taking their CAR, until Week 52. At the end of Early Switch Phase, eligible~     participants will proceed to the Late Switch Phase where all participants in both DTG + RPV~     and CAR treatment groups will receive DTG + RPV therapy until Week 148. After Week 148,~     subjects may be eligible to continue to receive DTG +RPV in the Continuation Phase. The study~     is planned to be conducted in approximately 476 participants.~   "
86886|NCT02429778|"~     The PI developed a self-directed program to treat late-life anxiety called Breathing,~     Relaxation, and Education for Anxiety Treatment in the Home Environment (BREATHE). This~     program consists of weekly video lessons that participants watch on digital video disc (DVD)~     along with weekly telephone check-ins. In BREATHE participants will learn two behavioral~     interventions: diaphragmatic breathing and progressive muscle relaxation (PMR). The purpose~     of the study is to examine whether the self-directed BREATHE program is superior to a wait~     list control in reducing anxiety in older adults with anxiety disorders. For those assigned~     to wait list control, they will be offered opportunity to participate in BREATHE treatment~     after 8 weeks of wait list.~   "
86887|NCT02429765|"~     A number of studies have documented poor sleep quality and troublesome symptoms~     (breathlessness, cough and sputum production) upon awakening in patients with COPD. However,~     the investigators know very little about measurements of respiratory mechanics (i.e., lung~     volumes, respiratory pressures, diaphragm function, etc) during sleep in these patients. The~     investigators also know little about how modern bronchodilator therapies, or the timing of~     when they are taken, affect respiratory mechanics during sleep or the severity of early~     morning respiratory symptoms. COPD is often treated with inhaled bronchodilator medications~     which are used to open up airways and make it easier for air to get in and out of the lungs.~     The investigators are studying the effects of a new inhaler that contains two different types~     of long-acting bronchodilator: formoterol [a long-acting beta2-agonist (LABA)] and aclidinium~     bromide [a long-acting muscarinic antagonist (LAMA) or anticholinergic]. Initial studies have~     shown that this combination therapy taken twice daily can improve some lung function~     measurements and respiratory symptoms in patients with moderate to severe COPD. There are~     also reports that evening administration of this medication may provide important advantages~     in patients with dominant nighttime and early morning symptoms. It is thought that sustained~     bronchodilation and lung deflation during the night may improve respiratory mechanics,~     diaphragmatic function, pulmonary gas exchange, sleep quality, and reduce severity of morning~     symptoms. This study will be the first to explore the effects of a nighttime dose of~     aclidinium/formoterol combination therapy on detailed measurements of respiratory mechanics~     and early morning symptoms in COPD. This study will also give us a better understanding of~     the mechanisms of early morning respiratory symptoms and their improvement with~     bronchodilators.~   "
86888|NCT02429752|"~     The goal of this study is to identify if there is a significant prevalence of abnormal~     respiratory patterns in a sample of patients with low back pain (LBP), and if the presence of~     abnormal respiratory patterns are predictive of rehabilitation outcomes in this population.~     In addition, the investigators will assess the response to inspiratory muscle training (IMT)~     for a subgroup of subjects that maintain abnormal breathing patterns after 1 month of~     physical therapy. Patients seeking physical therapy for LBP within the Uhealth system will be~     recruited. The first phase of this study will be observational. A comprehensive assessment of~     their respiratory function will be performed at the beginning of their therapy and after 1~     month of therapy. Subjects that demonstrate abnormal respiratory patterns after 1 month of~     therapy will be offered the opportunity to participate in the second phase of the study in~     which they will receive 1 month of inspiratory muscle training (IMT). The respiratory~     assessment will then be repeated at the end of the IMT training program.~   "
86889|NCT02429739|"~     The main aim of this interventional study is to investigate whether the effects of~     computerized working memory training improves reading abilities for children, i.e. ages 9 -~     16 years, diagnosed with dyslexia.~   "
86890|NCT02429726|"~     Objective of this study is to investigate of efficacy and safety of recombinant adenoviral~     human p53 Gene (rAd-p53) in treatment of malignant pleural effusion, compared to cisplatin.~     This is a phase 2, double blinded, randomized, active controlled study.~   "
86891|NCT02429713|"~     Tourniquets are still widely used in total knee arthroplasty, but are associated with several~     adverse effects. Most of previous studies did not randomize the participants so the baseline~     difference of the patients might have influenced the outcome. Therefore, investigators~     conducted a randomized controlled trial, in which all the patients received staged bilateral~     TKA with two different durations of tourniquet use. Investigators aimed to quantify the~     effect of tourniquet use on reducing blood loss and to evaluate the impact of tourniquet use~     on functional and clinical outcome.~   "
86892|NCT02429700|"~     Investigators will conduct the trial to determine whether paclitaxel and cisplatin (PT) has~     the same curative effects and less adverse effects than bleomycin, etoposide and~     cisplatin(BEP) among newly diagnosed ovarian malignant sex cord-stromal tumor patients after~     surgery.~   "
86893|NCT02429687|"~     Investigators will conduct the trial to determine whether paclitaxel and cisplatin (PT) has~     the same curative effects and less adverse effects than bleomycin, etoposide and~     cisplatin(BEP) among newly diagnosed malignant ovarian germ cell tumor patients after~     surgery.~   "
87147|NCT02426359|"~     This is a randomized, double-blind, vehicle-controlled, parallel-group comparison study to~     evaluate the safety and efficacy of Q301 Cream vs. vehicle in adult subjects with moderate to~     severe AD. Study drug (Q301 Cream or vehicle) will be administered topically twice a day for~     8 consecutive weeks.~   "
86894|NCT02429674|"~     The focus of this study is on identifying how Interpersonal Psychotherapy for Adolescents~     (IPT-A) with depression works to change sleep and related biological markers found in saliva,~     namely cortisol and pro-inflammatory cytokine levels. The long-term goal of this project is~     to understand the biological mechanisms of recovery from depression in order to assist in~     selecting and guiding personalized psychotherapeutic interventions with the highest~     likelihood of success for individual adolescents with depression.~   "
86895|NCT02429661|"~     The purpose of this study is to determine the social, emotional, physical, and educational~     effects of Girls First, a combined resilience and adolescent health program, vs. its~     components and a control group, among adolescents in India.~   "
86896|NCT02429648|"~     The purpose of this study is to compare which strategy is superior in patients with~     persistent/permanent atrial fibrillation (AF) undergoing ablation, direct current~     cardioversion (DCC) prior to empirical pulmonary vein isolation (PVI) ; or pulmonary vein~     isolation (PVI)ablation in atrial fibrillation then Direct current cardioversion (DCC) if the~     patient remains in atrial fibrillation.~   "
86897|NCT02429635|"~     The aim of this research study is to assess the effectiveness of an intervention on exercise~     and health, and to contribute to the understanding of how team-based worksite health~     promotion programs should be designed in order to increase and maintain exercise among~     employees. The study design is a randomized controlled trial.~      There are a number of different theories on the subject of how to affect motivation for~     health behavior change. This study is based on the tenets of Self-Determination Theory (SDT)~     in combination with elements from Motivational Interviewing and in accordance with the Health~     Promotion Guidelines developed by the National Institute of Health and Clinical Excellence,~     NICE.~      It is assumed that if such a program is designed and offered in a manner that satisfies the~     participants' sense of autonomy, competence and relatedness, this will affect the quality of~     the participants' self-regulated motivation and perceived competence for exercise and~     lifestyle changes. As a consequence, a large proportion of the participants will adhere to~     the program and increase their exercise both in the short (5 months) and long term (8~     months).~      The following research questions will be:~        1. Would a team-based health and exercise promotion intervention designed to be needs~          supportive, relative to a control group:~             1. Influence increases in exercise levels, improved aerobic fitness, reduced blood~               pressure, and decreases in waist circumference, and Body mass index (BMI), in~               addition to changes in body composition in terms of reduced percentage of fat and~               increased percentage of muscles?~             2. Influence increases in psychological well-being?~             3. Influence increases in perceived investment in employees' health competence, which~               would positively predict affective organizational commitment and job performance,~               and negatively predict turnover intentions?~             4. Influence decreases in sickness absenteeism?~        2. If so, would changes in psychological needs support, autonomous motivation for exercise,~          perceived competence and self-efficacy in exercise mediate these effects?~   "
86898|NCT02429622|"~     This phase Ⅰ/Ⅱ trial is designed to explore a higher radiation dose by using IMRT~     simultaneous integrated boost technique with or without concurrent chemotherapy for locally~     advanced esophageal carcinoma.~   "
86899|NCT02429609|"~     The measurement of visual acuity is made using black letters of varying size superimposed on~     a uniform white background. The objective is to determine the smallest letter, or optotype,~     that can be correctly identified. One limitation of current tests is the variability of~     measurements, this making it difficult for clinicians to determine if changes in visual~     acuity are related to ocular disease. This variability has been attributed to the design of~     current optotypes, in particular their differing legibilities. Our group has recently~     demonstrated that a new type of letter chart (Moorfields Acuity Chart), containing letters~     with a black core and a white border presented on a grey background, reduces the variability~     of visual acuity measurements. In this study the investigators wish to determine if changes~     in vision owing to keratoconus, a disease that causes the cornea to adopt an irregular shape,~     may be detected more easily using the Moorfields Acuity Chart compared with conventional~     letter charts.~   "
86900|NCT02429596|"~     Background. Anecdotal reports and uncontrolled studies have described an association between~     generic substitution of antiepileptic drugs (AEDs) and adverse events, including loss of~     seizure control. Although these results are likely to be influenced by methodological bias,~     they have led to a strong opposition, among physicians and patients, to the use of generic~     products in epilepsy.~      Objectives. The primary objective is to assess potential risks associated with substitution~     of the currently taken AED product with an equivalent product, using as endpoint changes in~     serum drug levels at steady-state after substitution compared with baseline. Secondary~     objectives will be the assessment of inter-subject variability in serum drug concentration on~     an unchanged treatment schedule, and evaluation of potential short-term changes in seizure~     control and adverse events rate.~      Methods. The study will use an experimental randomized open-label non-inferiority design. The~     population will consist of 200 adults stabilized on chronic treatment with carbamazepine,~     valproic acid, topiramate, oxcarbazepine, levetiracetam or lamotrigine and admitted to~     hospital for diagnostic evaluation or other indications, with no expected treatment changes~     during the subsequent 5 to 6 days. Patients will be randomized to two groups. One group will~     continue to receive the AED products used before enrollment (brand or generic), whereas the~     other group will be switched to an alternative equivalent product. Dosing schedules of the~     AEDs being tested as well as comedications will be unaltered throughout the 6- to 7day period~     of the study. Serum AED levels (mean of two values obtained at peak and trough, respectively~     in the evening and the next morning) will be measured on day 1 (baseline) and 5 days~     post-randomization (6 days for patients receiving AEDs with half-lives above 12 h). The~     primary outcome endpoint will be the proportion of patients who, post-randomization, show a~     greater than 25% change in serum drug concentration compared with baseline. Secondary~     endpoints will include comparison of distributions of rough serum concentration changes~     between groups, other pharmacokinetic parameters, time to first seizure, total number of~     seizures, and adverse events.~   "
86901|NCT02429583|"~     This study will investigate the effects of chronic HCV infection and corresponding innate~     immune activation on the immune response to HBV vaccination. We will recruit chronic HCV~     patients and healthy control patients for HBV vaccination. We will use RNA Sequencing~     (RNA-Seq), a relatively new technology for simultaneously measuring the expression of all~     genes, to determine patients' innate immune status, and learn how this innate immune~     signature is related to HBV vaccine response. We will then explore the mechanisms by which~     chronic HCV infection affects different immune cells and functions that are known to be~     important for an effective HBV vaccine response. These studies will enhance our understanding~     of the immune effects of chronic viral infection, establish factors that determine effective~     vaccine responses, and help guide vaccination strategies for HCV patients and other~     individuals with chronic inflammatory disease.~   "
86902|NCT02429570|"~     Cancer that has spread to the brain, or brain metastasis, is difficult to treat.~     Meclofenamate is a drug which has been shown to reduce brain metastasis growth in the~     laboratory. This medicine has been used in the past to treat pain. But, in this study, it~     will be used to prevent new brain metastasis. This is the first time that meclofenamate will~     be used in patients with brain metastasis.~      This is a pilot study which means that the purpose of this study is to determine if a larger~     clinical trial of meclofenamate is possible in patients with brain metastasis. This study~     also aims to find out what effects, good and/or bad meclofenamate has on the patient and the~     cancer that has spread to the brain. The investigators also want to learn more about~     potential effects that this drug may have in the digestive system.~   "
86903|NCT02429557|"~     Compression garments have been shown to be effective in the treatment of orthostatic~     hypotension in autonomic failure patients. The purpose of this study is to determine the~     hemodynamic mechanisms by which abdominal compression (up to 40 mm Hg) improve the standing~     blood pressure and orthostatic tolerance in these patients, and to compare them with those of~     the standard of care midodrine. The investigators will test the hypothesis that abdominal~     compression will blunt the exaggerated fall in stroke volume and the increase in abdominal~     vascular volume during head up tilt.~   "
86904|NCT02429544|"~     The goal of this behavioral research study is to compare 2 different types of residential~     group programs to help researchers learn if and how well these groups may help to improve~     physical and emotional well-being in patients with stage IV breast cancer.~   "
86905|NCT02429531|"~     Specific polysaccharide antibody deficiency (SPAD) is a primary immunodeficiency~     characterized by a deficient antibody production to capsular polysaccharides with normal~     total immunoglobulin levels. Patients suffer from recurrent ear-nose and throat infections~     and lung infections. SPAD can also occur as part of a primary immunodeficiency affecting~     other components of the immune system. Diagnosis of SPAD is hampered by difficulties with the~     interpretation of the Pneumovax 23 antibody response. The purpose of this study is to assess~     the diagnostic value of the Typhim Vi antibody response and allohemagglutinin titers as an~     alternative to the Pneumovax 23 response to detect polysaccharide specific antibody~     deficiency.~   "
86906|NCT02429518|"~     This study is a Phase 4, open-label, single group study in which at least 40 adult patients~     undergoing miltefosine treatment for mucocutaneous leishmaniasis (CL and ML) will be assessed~     by 12-lead ECG for prolongation of the corrected QT interval~   "
86907|NCT02429505|"~     This study is a prospective observational study in which patients undergoing treatment for~     leishmaniasis with miltefosine (Impavido) in the US and who weigh > 75 kg can volunteer to~     provide information about their clinical response to treatment up to 6 months after the start~     of treatment.~   "
86908|NCT02429492|"~     Amyotrophic lateral sclerosis (ALS) is due to neurodegeneration of upper and lower motor~     neurons, leading to muscle atrophy, paralysis and death. However, there is growing evidence~     that interneurons involved in the gain regulation of spinal motoneuron (lower motor neurons)~     and in sensorimotor integration may participate in the pathogenesis of ALS. While sensory~     afferents in the peripheral nerve are traditionally thought to be unaffected at the beginning~     of the disease, diffusion MRI has revealed degeneration and demyelination of the posterior~     columns in the spinal cord of patients recently diagnosed with ALS, and there are sporadic~     reports of sensory involvement. Early alteration of the sensorimotor integration could~     participate to the degeneration of motor neurons and interneurons. The goal of the project is~     to further investigate sensorimotor integration at spinal level in human patients recently~     diagnosed with ALS, and to study whether an interneuron pathology could participate in ALS~     pathogenesis.~      Our project has first an interest for the fundamental research aiming at increasing basic~     knowledge of pathophysiology of ALS, and specifically on the functional effects of the~     underlying neurodegenerative mechanisms. By testing the excitability of spinal interneurons~     in patients recently diagnosed, and by doing so for clinically uninvolved muscles, we will be~     able to evaluate whether an interneuron pathology could be involved in ALS. Our results will~     help to understand better the chain reactions in the neurodegenerative processes that~     dramatically evolve until the death of all motor neurons. Our project has also an interest~     for the development of therapeutic approaches for ALS. Indeed, our methods will help to~     determine specific electrophysiological biomarkers that will help to evaluate quantitatively~     spinal and corticospinal neural processes: their changes during the course of the disease~     (follow-up study), the effect of therapeutic agents and/or rehabilitation methods on their~     excitability, and their repercussions on motor neuron activity (evaluation of therapeutics).~     Lastly, our methods could be tested in other neuromuscular diseases to determine possible~     differences in spinal neural activity. Indeed, the motor dysfunction common to several~     neuromuscular diseases can make it difficult to make a definitive diagnosis. The development~     of specific biomarkers is crucial for an early diagnosis, and to evaluate the best treatment~     for the patients as rapidly as possible.~   "
86909|NCT02429479|"~     The overarching goal of the project is to improve the process and experience of surrogate~     decision-making by family caregivers. Since feeling unprepared to make surrogate decisions is~     a major contributor to caregiver stress, the primary outcome is caregiver self-efficacy~     --i.e., caregivers' assessment of how well prepared they feel to serve effectively as a~     surrogate decision-maker. Through follow-on Renewal funding, we are now also qualitatively~     examining family caregivers' experience with surrogate decision-making.~   "
86910|NCT02429466|"~     This is an open-label, single arm, Phase I dose escalation study in subjects with refractory~     germ cell tumor (rGCT). This phase I will evaluate the safety and efficacy of SGI-110 in~     combination with cisplatin in subjects with rGCT. The primary objective is to determine the~     maximum tolerated dose (MTD) of SGI-110 to be used prior to cisplatin. A total of 15 subjects~     will be enrolled in this study at the Indiana University Simon Cancer Center.~   "
86911|NCT02429453|"~     The goal of this study will be to determine whether PCC confers any benefits over FFP in~     traumatic and spontaneous intracranial hemorrhage with respect to multiple factors including~     time to correction, absolute international normalized ratio correction amount, cost, need for~     surgical intervention, and radiographic bleed expansion through a prospective, randomized~     control trial.~   "
86912|NCT02429440|"~     Clinical Phase I/II study to investigate the feasibility and tolerability of synthetic~     adjuvant peptide immunisation in combination with immune adjuvants (granulocyte macrophage~     colony stimulating factor; Montanide ISA-51) in patients with advanced renal cell cancer~     (RCC).~   "
86913|NCT02429427|"~     It has been found that the chemical changes that take place in a patient's body during the~     development of inflammation may provide an environment which stimulates cancer cells. One~     step in the development of inflammation is the production of certain chemical substances~     which are important in the formation and spread of tumours. These are called prostaglandins.~     Cyclo-oxygenase II (COX-2) is an enzyme (a substance that speeds up chemical changes in the~     body) involved in the production of these prostaglandins and although it is not usually~     present in most tissues it is made at the sites of inflammation. Celecoxib is a selective~     Non-Steroidal Anti Inflammatory Drug (NSAID) which works by blocking the action of the COX-2~     enzyme, leading to a decrease in the production of prostaglandins and a reduction in~     inflammation.~      The purpose of this study is therefore to find out if celecoxib can be used after breast~     cancer treatment (chemotherapy and/ or radiotherapy) to reduce inflammation and thus reduce~     the ability of new tumours to grow and survive.~      2590 women with primary breast cancer will be recruited in this study from several locations~     in the United Kingdom and Germany. Eligible patients will be randomly allocated a treatment~     group, which can be celecoxib or placebo. Both treatments are taken orally (celecoxib 400mg~     daily, placebo 2 tablets daily) for a total of 2 years. In addition, hormone receptor~     positive patients will receive endocrine treatment as per local practice. Patients will~     prematurely discontinue treatment with celecoxib/placebo if disease progression is confirmed~     or if patients experience unacceptable toxicity.~      Patients will be seen every 6 months for the first 3 years and then off treatment follow-up~     is carried out annually. Participating patients will also be given the option to take part in~     the pathology sub-study by donating a sample of the tumour tissue collected at the time of~     the primary surgery.~   "
86914|NCT02429414|"~     The goal of this clinical research study is to learn how often a fiberoptic bronchoscopy (FOB~     -- also known as a fiberoptic scope procedure) needs to be used with a video double lumen~     tube (VDLT) during surgeries that require lung isolation. On this study, you will have one of~     2 types of commonly-used breathing tubes used, either a VDLT or a non-video double lumen tube~     (called a non-video DLT). An FOB may or may not be performed, as described below.~      The level of effectiveness of the VDLT and non-video DLT will be compared.~   "
86915|NCT02429401|"~     In this comparative-effectiveness study, investigators will recruit 400 English-speaking,~     Spanish-speaking, or bilingual heavy-drinking Mexican-origin men admitted to a community~     hospital for medical treatment of an alcohol-related injury or heavy drinking. Participants~     will be randomized to receive a culturally adapted brief motivational intervention (CA-BMI)~     or a non-adapted brief motivational intervention (NA-BMI). The primary outcomes of interest~     include alcohol use, alcohol problems, and treatment utilization. Secondary outcomes include~     therapeutic alliance ratings and social support. Telephone follow-up assessments will be~     completed at 3, 6, and 12 months post-treatment.~   "
86916|NCT02429388|"~     Prospective, open-label, randomized cohort study comparing adding high-dose spironolactone to~     usual heart failure care versus usual care in patients with acute decompensated heart~     failure. Patients will be randomized in a 1:1 fashion to either usual care or high-dose~     spironolactone plus usual care. Both arms of the study will continue with treatment of ADHF~     until euvolemia as defined as the resolution of pulmonary edema, peripheral edema, abdominal~     bloating and/or jugular venous distention. Assessment of clinical status and serum~     electrolytes, symptoms and renal function will be performed in accordance to standard of~     care.~   "
86917|NCT02429375|"~     The purpose of this study is to find out how safe and effective treatment with a new~     combination of drugs, mocetinostat and brentuximab vedotin, is in treating cancer. There will~     be 2 parts to this trial: a phase I part and a phase II part.~      Brentuximab vedotin is approved by the U.S. Food and Drug Administration (FDA) to be given to~     patients with Hodgkin Lymphoma. Mocetinostat is an experimental drug that has been given to~     patients with Hodgkin lymphoma in another clinical trial. When given alone, mocetinostat~     caused lymphoma to shrink in about 1 out of 4 patients with Hodgkin lymphoma. This is the~     first study that will give mocetinostat and brentuximab vedotin together.~   "
86918|NCT02429362|"~     Subjects are being asked to donate blood, urine, vaginal secretions and/or tissue to a~     repository for research.This repository will store donated specimens for future research. The~     Department of Obstetrics and Gynecology at the University of Tennessee Health Science Center,~     under the direction of Dr. Giancarlo Mari, Professor and Chair, is responsible for the~     operation of the repository.~      Additionally, in the case of a stillborn child, the mother will be given the opportunity to~     donate samples from her stillborn baby's autopsy to a repository for research.~   "
86919|NCT02429349|"~     The purpose of this study is to assess the results of ovarian tissue freezing, such as~     resumption or initiation of menses (menstruation: the discharge of blood and tissue from the~     uterus that happens about every 4 weeks in females who are not pregnant) and pregnancy, prior~     to starting chemotherapy or radiation treatment (commonly used for cancer treatment or for~     other conditions such as multiple sclerosis, psoriasis, rheumatoid arthritis). Females who~     are about to undergo chemotherapy or radiation therapy for cancer or these other medical~     conditions may stop having menses and may not be able to produce a biological child. Girls~     who have not achieved puberty and are exposed to chemotherapy (alkylating agents) or~     radiation treatment, the risk is up to 22-50%. In contrast, girls older than 10 years, or who~     have achieved puberty, experience acute ovarian failure in over 50% of the cases. By freezing~     and preserving ovarian tissue will help prevent these outcomes. In fact, when you are~     considered cured of your disease, you will have another surgical procedure where your own~     ovarian tissue will be transplanted back to you. This surgery will increase the possibility~     of resuming/initiating menses and the chance to have a pregnancy.~   "
86920|NCT02429336|"~     The purpose of this study is to collect data that will be generated during an office visit.~     The data will be gathered and analyzed in research studies that will help with the~     investigators understanding of various medical conditions.~      About 200 subjects will be participating in this study. Participation in this study will not~     require a patient's time or presence. The medical information contained in a patient's chart~     from the office visit, including the results of any tests that were ordered at that time,~     will be transferred to an anonymous database and analyzed together with data from other~     patients who have similar condition/s.~      No follow-up information will be collected. The following information will be collected from~     a patient's medical record: the medical history and a list of the current medications.~   "
86921|NCT02429323|"~     Aim of the study is to compare the optimal time needed for successful tracheal intubation~     with immediate 8% sevoflurane and incremental sevoflurane induction in surgical pediatric~     patients undergoing adenotonsillectomy without using muscle relaxants or opioids~   "
86922|NCT02429310|"~     This study will assess the adjuvant benefit of a neuromuscular electrical stimulation device~     to standard treatment of supervised exercise in patients suffering from symptoms and effects~     of lower limb Intermittent Claudication.~   "
86923|NCT02429297|"~     The purpose of the study is to evaluate the feasibility and impact of an automated phone~     system in monitoring and improving self-care and health outcomes among patients with diabetes~     and/or hypertension in Bolivia, in addition to assessing the additional benefit of support~     from a family member or friend.~   "
86924|NCT02429284|"~     The U.S. CTEPH Registry is a multicenter, observational, U.S.-based study of the clinical~     course and treatment of patients diagnosed with chronic thromboembolic pulmonary hypertension~     (CTEPH), WHO Group IV Classification for Pulmonary Hypertension. The mission of the Registry~     will be to promote a greater understanding of the prevalence, pathophysiology, evaluation,~     and treatment of patients with CTEPH through shared information, education, and collaborative~     investigation among pulmonary hypertension (PH) centers of excellence throughout the U.S.~   "
86925|NCT02429271|"~     This is a prospective randomized study, which investigates the coronary microvascular~     function as assessed by coronary angiography after administration of ticagrelor compared with~     clopidogrel in patients with myocardial infarction and ST segment elevation after~     thrombolysis.~   "
86926|NCT02429258|"~     Effect of Dapagliflozin on 24-hour Blood Glucose in Type 2 Diabetes Patients Inadequately~     Controlled With Either Metformin Or Insulin~   "
86959|NCT02428816|"~     Based on previous promising results, the next step for the validation of a multimodal MRI~     method in diagnosis and follow up of patients reached by parkinsonian syndromes is (i) to~     test whether the multimodal neuroimaging is able to discriminate at the individual level,~     patients with multiple system atrophy parkinsonism (MSA) and patients with idiopathic~     Parkinson's disease (PD) (ii) to determine whether the method is sensitive to measure changes~     over time for the two diseases, according to imaging, neuropsychological and other clinical~     data.~   "
86927|NCT02429245|"~     The knee prosthesis is a validated treatment for end-stage of knee osteoarthritis, and this~     intervention usually provides a significant improvement in the quality of life of patients.~     However, a significant percentage of patients (up to 30%) are disappointed with the outcome~     of the intervention. One hypothesis that could explain these poor results might be the poor~     positioning of implants. Individual cutting guides are produced after a CT scan response~     planning carried out according to the CT scan anatomy of each patient, and subsequently~     adapted to its real anatomy during surgery, thus theoretically better accuracy of the~     implementation over conventional techniques. It has been shown in the past that the~     navigation has been the gold standard in measuring the three-dimensional orientation of the~     implants during surgery, and this system is systematically used in the service for over 10~     years.~   "
86928|NCT02429232|"~     Diabetes mellitus is a common disease with much impact on human's health and is related to~     osteoporosis. But the mechanism remains unclear. The foreign researches revealed~     thiazolidinedione (TZD) would increase the risk of osteoporosis and bone fracture, specially~     elderly women. However, it is still controversial in terms of the youth and men. In~     Taiwan,there is few related study to analyze the relationship between TZD and steoporosis.~      This is a multicenter randomized controlled study.~   "
86929|NCT02429219|"~     Transurethral therapy (TURiS / PVP) of benign prostatic hyperplasia (BPH) using an~     ethanol-containing saline irrigating fluid, prospective detected by breath alcohol~     measurement.~   "
86930|NCT02429206|"~     In the general population, xerosis is often caused by external factors such as seasonal~     changes. In that case, the best way to relieve dry skin is to use a standard moisturizer.~     However, for those suffering of mobility problems due to age or paralysis (e.g., spinal cord~     injury, multiple sclerosis, Parkinson's, etc), xerosis is often severe and chronic because of~     the multiple causes (endogenous rather than exogenous ones) underlying such mobility~     impairment-related skin problems. This study is a double-blind, randomized study with~     positive control (active comparator) to assess the safety and efficacy of SQIN with CanSATs~     (Co-Activation of Natural Synergistically Acting Target-receptorS) technology on dry skin in~     patients suffering of paralysis.~   "
86931|NCT02429193|"~     This is an open-label phase 2 multi-center study of abiraterone and enzalutamide in men with~     castration-resistant prostate cancer. Sixteen patients will be enrolled over 18 months.~   "
86932|NCT02429180|"~     A pilot study that will evaluate the feasibility and acceptability of procedures to inform~     the design and delivery of a definitive RCT of ReTrain (which would assess the clinical and~     cost effectiveness of ReTrain for stroke survivors).~   "
86933|NCT02429154|"~     The purpose of this study is to show that a permissive hypercapnia during mechanical~     ventilation in children under general anaesthesia will improve cerebral perfusion.~   "
86934|NCT02429141|"~     In the transarterial technique for axillary brachial plexus block, the axillary artery is~     intentionally punctured to indicate placement of the needle within the neurovascular sheath;~     local anesthetic is then injected deep and superficial to the axillary artery.~   "
86935|NCT02429128|"~     The aim of this project is to investigate the pathophysiology of PCOS in regards to the~     metabolic profile including defects in insulin sensitivity in skeletal muscle and adipose~     tissue, and to investigate the effects of exercise training on these parameters.~   "
86936|NCT02429115|"~     Receiving supportive mentoring from well-adjusted individuals who share similar experiences~     has had a positive influence on adjustment with some chronic diseases. In this study,~     patients with advanced chronic kidney disease and caregivers of such patients will be~     randomly assigned to one of three groups: (1) face-to-face PFPP—individuals will receive six~     months of PFPP peer-mentoring, along with an informational text; (2) online PFPP—individuals~     will receive six months of online peer-mentoring modeled after the PFPP program, along with~     an informational text; and (3) information-only control group—individuals will receive the~     text of the material provided to the other two groups. The study team's decision to include~     an online version is based on suggestions by previous participants who indicated that this~     would be convenient for individuals for whom distance and geographic location are major~     considerations of participation.~      The investigators expect that both face-to-face and online peer-mentorship programs will~     result in improved quality of life among patients with advanced kidney disease and decreased~     feeling of burden among caregivers of these patients. The investigators also expect that~     mentorship will lead to improved engagement of patients in their own care.~   "
86937|NCT02429102|"~     The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of~     MT-8554 in healthy Caucasian subjects.~   "
86938|NCT02429089|"~     In this trial, the investigators would like to investigate the activity of LEE011 associated~     with cetuximab (standard of care for the SCCHN patients at this stade of the disease).~   "
86939|NCT02429076|"~     The aim of this study is to test the hypothesis that methylphenidate actively induces~     emergence from propofol and sevoflurane general anesthesia in healthy volunteers.~   "
86940|NCT02429063|"~     Fatigue is one of the most consistent and distressing symptoms reported by pediatric oncology~     patients. The investigators' work has demonstrated that in the period from diagnosis through~     the initial 8 weeks of treatment, adolescents and young adults with solid tumors experience~     substantial fatigue that is not related to sleep disruption. Fatigue can contribute to many~     adverse outcomes including poor treatment adherence, reduced social activities, depressive~     symptoms, behavior problems, and poorer quality of life. Unfortunately, no definitive~     intervention to reduce fatigue has been developed for pediatric oncology patients.~     Investigators propose a study to estimate the feasibility and acceptability of bright light~     therapy as an intervention to decrease fatigue in adolescents and young adults who are newly~     diagnosed and receiving treatment for solid tumors, including lymphoma.~   "
86960|NCT02428803|"~     Home dialysis patients must be seen in a face to face visit on a monthly basis. For patients~     who live remotely these visits may impact their quality of life due to the amount of time~     needed to attend these visits. The central hypothesis is that implementation of telemedicine~     visits as a substitute for the 2 out of 3 monthly face-to-face visits over a 6 month period~     will improve quality of life as judged by the quality of life (QoL) indices Kidney Disease~     Quality of Life - Short Form and the Illness Intrusiveness Ratings Scale when compared to QoL~     scales taken during a time period when the patient is on standard of care.~   "
86941|NCT02429050|"~     Dyspnea is the most reported symptom of patients with advanced Chronic Obstructive Pulmonary~     Disease (COPD) and is undertreated. Morphine is an effective treatment for dyspnea and is~     recommended in clinical practice guidelines, but questions concerning benefits and concerns~     about respiratory adverse effects remain. For example, the effect on health-related quality~     of life and functional capacity is unknown. In one-third of the patients oral sustained~     release morphine (morphine SR) doesn't relieve dyspnea and it remains unknown whether~     severity and descriptors of breathlessness may predict a response to morphine. Finally,~     cost-effectiveness of morphine SR in this patient group is unknown. Therefore, prescription~     of morphine to patients with COPD is limited.~      Objectives of this double blind randomized controlled trial are to study the effect of oral~     administration of morphine SR on health-related quality of life, respiratory adverse effects,~     and functional capacity; to explore whether description and severity of breathlessness are~     related with a clinically relevant response to morphine and to analyse the cost-effectiveness~     of morphine SR. The study population will consist of 124 clinically stable outpatients with~     COPD and severe dyspnea despite optimal pharmacological and non-pharmacological treatment.~   "
86942|NCT02429037|"~     The objectives of this study are to investigate the efficacy and safety of rAd-p53 gene~     combined with radio- and chemo-therapy vs. radio- and chemo- therapy only in treatment of~     unresectable, locally advanced head and neck cancer. This is a phase 2, open labeled, and~     active-controlled study.~   "
86943|NCT02429024|"~     Assessment of SMS and Smartphone Interventions for OneTouch Reveal® Experiences with patients~     with Type I and Type II diabetes.~   "
86944|NCT02429011|"~     The purpose of this study is to research the effects of ketamine on brain function in~     patients with Major Depressive Disorder (MDD). This study is an ancillary MRI neuroimaging~     study being conducted in patients with MDD who are enrolled in a separate clinical trial.~     Healthy control volunteers are also enrolled. No drug or other intervention is given as part~     of this protocol per se.~      To study brain activity related to emotion, the study team will use a technology called~     functional MRI (fMRI), which is a method for evaluating the flow of blood in the brain using~     a powerful magnet. fMRI does not involve exposure to radiation.~      Patients will be shown a sample of images on a computer screen designed to bring about an~     emotional reaction. The MRI machine will then take a number of pictures of your head. By~     computer analysis, this machine is able to create a picture of your brain's activity. There~     are several tasks during scanning that involve looking at various images that represent~     different emotions, and the study team will be monitoring brain activity during these tasks.~      Patients will be scanned before and 24 hours after receiving ketamine (as part of a separate~     study) to analyze treatments effects. These scans are compared to depressed patients who did~     not receive ketamine, as well as to healthy controls.~   "
86945|NCT02428998|"~     Korean Red Ginseng appears to adverse events in adults taking 24 weeks Placebo and~     comparative assessment. And exploratory as Korean Red Ginseng blood sugar control, reduce~     body fat, URTI prevention, cardiovascular risk, renal function, cholesterol, improve,~     fatigue, and determine the impact on biological age.~   "
86946|NCT02428985|"~     The primary objective in this study is to collect post-marketing information on Riociguat~     safety.Thus, the information on adverse events (AEs) and adverse drug reactions (ADRs) that~     occur within the first 12 months and in the following 6 -year observation at most, after~     starting Riociguat treatment under the routine clinical practice will be collected.~      The secondary objectives are collecting information on Riociguat effectiveness, such as~     6-Minute Walking Distance (6MWD) Test. Since it is assumed that Riociguat is for long-term~     use, information on Pulmonary Arterial Hypertension (PAH) clinical worsening will also be~     surveyed once a year.~   "
86947|NCT02428972|"~     Primary brain tumors are highly associated with neurocognitive deficit and poor quality of~     life. There are number of studies indicating that brain tumors and their treatment modalities~     are often related to cognitive dysfunction. Apart from primary brain lesions, deficit can~     also occur because of Surgery, Radiotherapy, Chemotherapy, Antiepileptic and Corticosteroid~     treatment.Anaesthesia can also add to cognitive deficit in these patients. According to Ali~     et al. propofol provides better cognition scores compared to sevoflurane than isoflurane. The~     primary aim of their study was to compare the effects of 3 anesthetic regimens on~     hemodynamics and recovery characteristics of the patients. However in another study by Magni~     et al., the authors found that there is no difference in early cognitive function between~     sevoflurane and propofol. The aim of this prospective, randomized, open-label clinical trial~     was to compare clinical properties of sevoflurane-fentanyl with propofol-remifentanil~     anesthesia in patients undergoing supratentorial intracranial surgery. However both these~     studies evaluated the early cognitive function. The primary endpoint was to compare early~     postoperative recovery and cognitive functions within the two groups. They also evaluated~     hemodynamic events, vomiting, shivering, and pain. The literature is scarce on the severity,~     incidence and effect of anaesthetics on cognition and quality of life of these patients.~     Since most of the patients of brain tumor cannot be cured with surgery alone, improvement of~     quality of life and palliative care of the symptoms and cognitive function are important part~     of the treatment. Now the cognitive function has also been considered as an independent~     prognostic factor in the survival of patients of brain tumor. Cognitive function can also be~     related to tumor laterality. Patients with tumors in left hemisphere will have lower scores~     on verbal tests, whereas tumor in right hemisphere will have lower scores on facial~     recognition tests. Patients with tumors in the left hemisphere report more difficulty~     concentrating and those with right-hemisphere lesions,report more tension. Patients with~     primary brain tumors also experience serious challenges to their quality of life (QOL). These~     patients may face motor deficits, personality changes, cognitive deficits, aphasia, or visual~     field defects.~   "
86948|NCT02428959|"~     This research is being done to see if a study drug called amyl nitrite can be helpful with~     diagnosing different disorders affecting the lower esophageal sphincter in patients with~     dysphagia (difficulty swallowing foods) undergoing high resolution esophageal manometry~     (HRM).~      Dysphagia may be one of the symptoms of a condition known as idiopathic achalasia. Achalasia~     is a disorder of the esophagus, the tube that carries food from the mouth to the stomach.~     This affects the ability of the esophagus to move food toward the stomach. Pseudoachalasia is~     a secondary form of achalasia, which has very similar symptoms but is caused by different~     reasons. Because the treatments for achalasia and pseudoachalasia are different, it is~     important to correctly diagnose each condition. At this time, there is no way to distinguish~     the two with the current tests used at Johns Hopkins.~      Amyl nitrite relaxes vascular smooth muscle and has been studied previously as a potential~     means to separate achalasia from pseudoachalasia. Amyl nitrite is approved by the Food and~     Drug Administration (FDA) for the treatment of cardiac angina. It is not approved for use in~     motility testing and its use in this study is considered investigational. Investigators hope~     that the results from the proposed study could have significant clinical implications for~     patient management by helping doctors distinguish between achalasia and pseudoachalasia and~     allow them to choose appropriate treatment.~      Patients with dysphagia (difficulty swallowing foods) undergoing routinely scheduled high~     resolution esophageal manometry (HRM) may join this study.~   "
86949|NCT02428946|"~     In this study the investigators will examine the effect of dopamine (bromocriptine) on~     insulin sensitivity in lean and obese subjects. Furthermore, the investigators will examine~     whether the timing of bromocriptine administration has influence on insulin sensitivity.~      To do so, the investigators will include lean and obese subjects who will use 2 times 2 weeks~     bromocriptine. In randomized order, they will use it in the morning or in the evening.~      The investigators will examine insulin sensitivity by performing a 7-point oral glucose~     tolerance test.~      Furthermore, the investigators will examine energy expenditure and subjects will keep track~     of their eating behaviour in the 3 days before each study visit.~   "
86950|NCT02428933|"~     In this study the investigators will investigate the effect of dopamine (bromocriptine) on~     Brown Adipose Tissue in lean, young, healthy males.~      The investigators will also examine energy expenditure, body temperature and insulin~     sensitivity as measurements of Brown Adipose Tissue activity.~   "
86951|NCT02428920|"~     The Grenada Heart Project (GHP) conducted an observational study within a randomly selected~     adult sample of Grenadians in 2008-2009. The aim of the study was to assess the clinical,~     biological and psychosocial determinants of the cardiovascular health in Grenada, in order to~     develop and implement a nationwide cardiovascular health promotion program.~      The sample of 2,827 adults was randomly selected from the national electronic voter list. The~     main outcome measures were self-reported cardiovascular disease and behavioral risk factors,~     anthropometric measures, blood pressure (BP), point-of-care testing for glucose and lipids,~     and ankle-brachial index. Analysis of the data revealed prevalence rates of obesity,~     hypertension and diabetes significantly exceeding those seen in the U.S.~      Since the completion of this assessment, an additional effort has contributed significantly~     to the current project. A parallel community health-promotion project was carried out in~     Cardona, Spain called the Cardona Integral Fifty-Fifty project with 80 subjects. The~     preliminary results of the Cardona study have a shown that peer motivation may significantly~     improve healthy behaviors and thus modify cardiovascular risk.~      The GHP CHANGE community -based intervention aims to promote positive behaviors and focus~     more on what creates health, rather than what prevents sickness. It is built on the~     foundations of social support, assessing whether people going through similar challenges will~     support each other, work together to identify and address barriers to success, and motivate~     each other to move forward. In this program we test for the impact of promotion of healthy~     lifestyle behaviors through peer motivation on blood pressure, physical activity, eating~     behavior, weight, and smoking.~   "
86952|NCT02428907|"~     Some patients experience a degree of pain and discomfort during endoscopic examination of the~     large bowel. Sedatives and analgesics may be administered in low doses. Excessive dosage or~     intense pain may lead to hypotension and impaired level of consciousness. The purpose of the~     present study was to determine if simulation training of endoscopy staff in preventing pain~     and handling acute complications through effective teamwork could improve the quality of~     colonoscopy from the patients' perspective.~   "
86953|NCT02428894|"~     The purpose of this study is to characterize changes in the plasma proteome over time~     following left ventricular assist device (LVAD) implantation.~   "
86954|NCT02428881|"~     Hypothesis / aims of study~      Urinary retention is uncommon in young women, and one cause is a primary disorder of urethral~     sphincter relaxation, characterised by an elevated urethral pressure profile and specific~     findings in the urethral sphincter EMG (Fowler's Syndrome). Women may present with symptoms~     of obstructed voiding or complete urinary retention. Clean intermittent self-catheterisation~     is often painful to perform and currently, the only treatment to show benefit is sacral~     neuromodulation. This aim of this pilot study is to assess the efficacy of urethral sphincter~     injections of botulinum toxin, defined as improvement of flow rates by more than 50%,~     improvement in residual volume and scores on the IPSS questionnaire, and safety, in women~     with Fowler's Syndrome.~      Study design, materials and methods In this open label pilot institutional review board~     approved study, ten women with a primary disorder of urethral sphincter relaxation (elevated~     urethral pressure profile (UPP), sphincter volume and abnormal EMG) presenting with~     obstructed voiding (n=5) or in complete urinary retention (n=5) are recruited from a single~     tertiary referral centre. Baseline symptoms are being assessed using the IPSS questionnaire,~     and urinary flow and post-void residual volume were measured. After 2% lidocaine injection,~     100U of onabotulinumtoxintypeA is being injected into the striated urethral sphincter,~     divided on either side, under EMG guidance. Patients are being reviewed at weeks 1, 4 and 10~     post-treatment and symptoms are reassessed using the IPSS questionnaire, and urinary flow and~     post-void residual volume are being measured. The UPP is being repeated at week 4.~   "
86955|NCT02428868|"~     It is a prospective randomized controlled study aiming to test if tranexamic acid combined to~     intravenous iron before and after surgery for hip fracture in elderly can decrease~     peri-operative red cell transfusion.~   "
86956|NCT02428855|"~     This research study is studying Dasatinib as a possible treatment for cancer of bile ducts.~   "
86957|NCT02428842|"~     Prospective Multicentric European trial for Cervical cancer, not previously treated, with~     tumour biopsies, and blood collection for molecular analysis at predetermined time points.~   "
86958|NCT02428829|"~     This study looks to examine the effect of attempting initial postoperative walking with a~     patient following a total hip replacement. Currently patients rest in bed for approximately~     24 hours following their operation before walking. The intervention group would aim to~     commence walking at between 4-6 hours after their operation.~      Outcome measures to be examined would be: length of hospital stay, patient experience of~     physiotherapy treatment, the time taken for patients to reach functional milestones and~     number of postoperative medical complications.~      The study is designed as a randomised controlled trial where participants would be separated~     randomly into two groups. One group would form the intervention group and start physiotherapy~     and attempted walking 4-6 hours after their operation. The other group would form the control~     group and would remain on the current standard rehabilitation protocol.~   "
86961|NCT02428790|"~     Empirically patients with acquired brain injury (ABI) are often constipated. This is a major~     clinical issue. Nevertheless, this has only been sparsely studied.~      The investigators will measure gastrointestinal transit time (GITT) in 30 patients with ABI,~     and compare this to healthy controls. Secondly heart rate variability (HRV) is measured in~     these patients, and associations between HRV and GITT are investigated.~   "
86962|NCT02428777|"~     The purpose of this study is to compare the effectiveness of Tramadol and diclofenac in~     reducing pain during operative outpatient hysteroscopy. Women undergoing operative~     hysteroscopy will be divided into 3 groups, the first group will receive Tramadol 100 mg 1~     hour before the procedure, the second group will receive diclofenac 100mg 1 hour before the~     procedure and the third will receive a placebo. Pain will be assessed by a visual analogue~     scale~   "
86963|NCT02428764|"~     The purpose of this study is studying induction nimotuzumab plus gemcitabine and carboplatin~     followed by surgery to see how well it works in treating patients with unresectable stage III~     squamous cell lung carcinoma.~   "
86964|NCT02428751|"~     The combination of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone~     (R-CHOP regimen) has been the first-line chemotherapy for elderly patients with diffuse large~     B-cell lymphoma (DLBCL). The treatment-related toxicities, especially the severe cardiac~     toxicities induced by anthracycline drugs (doxorubicin), have become a major concern among~     elderly patients. Pegylated liposomal doxorubicin is a formulation of doxorubicin with a~     prolonged circulation time and unique toxicity profile. Previous single arm studies of~     elderly patients with lymphoma used pegylated liposomal doxorubicin instead of traditional~     doxorubicin in combination with rituximab, cyclophosphamide, vincristine, and prednisone (the~     novel R-CDOP regimen), and demonstrated better safety profile, including less bone marrow~     suppression and less cardiac toxicities, while maintaining the efficacy. However, the~     efficacy and safety of these two regimens (R-CHOP and R-CDOP) have not been head-to-head~     compared in a randomized study. The aim of this study is to compare the efficacy and safety~     of R-CDOP (rituximab, cyclophosphamide, pegylated liposomal doxorubicin, vincristine, and~     prednisone) and R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and~     prednisone) in previously untreated elderly patients with DLBCL.~   "
86965|NCT02428738|"~     Influenza virus accounts for numerous cases (epidemics) of respiratory illnesses each year~     worldwide and affects people of all ages. These epidemics typically occur in the winter~     months, and can result in substantial morbidity and mortality in persons at risk. Pregnant~     women may be more susceptible to morbidity and mortality associated with influenza infection.~     This increased risk may result from several factors including increased heart rate, stroke~     volume, and oxygen consumption, decreased lung capacity, and changes in immunologic function.~     Immunization of women during pregnancy can help to prevent infection in the woman herself and~     may also offer protection to the infant in two ways: by the passage of antibodies from mother~     to the fetus during pregnancy, and by preventing infection in the mother and therefore~     decreasing the infant's exposure risk after birth. In Canada, the National Advisory Committee~     on Immunization (NACI) recommends the vaccine for pregnant women who are expected to deliver~     during influenza season because they will become household contacts of their newborn. Ideal~     timing of vaccination occurs in October or November since influenza outbreaks typically occur~     throughout the winter months. Despite the Canadian and American guidelines for influenza~     vaccination during pregnancy, it is unclear how many women are offered and/or actually~     receive the vaccine while pregnant. There is, however, evidence that women will accept the~     vaccine if offered. Specifically, in the Women's Health Care Centre at St. Michael's~     Hospital, it was found that 42% of women not only accepted but also received the influenza~     vaccination when offered. Innovative techniques will be required to continue to increase~     vaccination rates among vulnerable populations, including pregnant women. The purpose of the~     present study is to determine if the use of electronic reminders (text messages) increases~     the likelihood of receiving the influenza vaccine among pregnant women.~   "
86966|NCT02428725|"~     This study will try to determine if the measure of the platelet reactivity of the patients~     receiving from the ticagrelor continuation in an acute coronary syndrome handled by coronary~     angioplasty allows to predict the hemorrhagic risk.~   "
86967|NCT02428712|"~     The objective of this study is to determine the safety, pharmacokinetics, maximum tolerated~     dose/recommended Phase 2 dose, and efficacy of PLX8394.~   "
86968|NCT02428699|"~     This study is designed to compare the incremental area under the curve from 0 to 24h~     (iAUC0-24h) of plasma levels of n-3 fatty acids (sum of total and free eicosapentaenoic acid~     (EPA) and docosahexaenoic acid (DHA)) after ingestion of an emulsified product and a~     non-emulsified reference control of free flowing cod liver oil at the lowest appropriate dose~     that is practically acceptable, and as near as possible to the test products' recommended~     daily dose.~   "
86969|NCT02428686|"~     Chronic anemia is the symptom most frequently found at diagnosis in low risk myelodysplastic~     syndrome. It generates an increased rate of morbidity and mortality in this population of~     patients whose median age is high and the rate of co-mobidities important. The historical~     treatment is limited to transfusion support with a significant impact on quality of life and~     the incidence of secondary haemosiderosis, which contributes to the emergence of~     co-morbidities, especially cardiovascular. Treatment with rHuEPO allows for overall erythroid~     response in 40-60% of patients treated.~      In this trial, the investigators intend to study the interest of a treatment with epoetin~     beta in patients with anemia <10 g / dL in the context of a myelodysplastic syndrome with~     IPSS score <1.~      In addition to studying the erythroid response, the investigators will measure the impact on~     quality of life and functional performance.~      Patients will receive epoetin beta (60 000UI/week). Response will be assessed after 12 and 24~     weeks of treatment.~   "
86970|NCT02428673|"~     Children with neuromuscular disabilities and limited ambulation are at significant risk for~     decreased bone mineral density (BMD) and increased incidence of fracture. This is caused, in~     part, by low levels of load experienced by the skeleton due to a child's functional~     limitations. Low BMD has been shown to be predictive of fracture, and in fact, fractures~     usually occur without significant trauma in children with neuromuscular conditions. The~     discomfort and distress from fractures in this population are considerable, and the~     associated costs to the family and healthcare system are substantial. Numerous interventions~     have been devoted to improving BMD in these children. Stationary assisted standing devices~     are widely used and represent the standard-of-care. However, evidence supporting this~     approach is limited due to inadequate study designs with insufficient numbers of patients.~      This study will use load-sensing platforms in patients with neuromuscular conditions.~     Successful completion of this pilot study will assist in the development of a future~     multicenter clinical trial to definitively determine relationships, if any, between passive~     standing and measures of BMD, fracture incidence, pulmonary function, and health-related~     quality-of-life measures in children with a variety of neuromuscular disabilities (e.g.,~     spinal muscular atrophy, cerebral palsy, muscular dystrophy, spina bifida, Rett syndrome).~      Hypothesis: Assisted standing treatment program will gradually increase their duration of~     standing by up to 75% after the baseline phase.~   "
87338|NCT02423863|"~     The purpose of this study is to evaluate the safety of sequential intratumoral (IT) plus~     intramuscular (IM) Polyinosinic-polycytidylic acid stabilized with polylysine and~     carboxymethylcellulose (poly-ICLC, Hiltonol®) for treatment of study subjects with advanced~     accessible solid tumors~   "
86971|NCT02428660|"~     This randomized controlled trial will evaluate whether the use of pharmacogenetic testing~     through a Medication Therapy Management (MTM) program has a beneficial impact on drug therapy~     problems. More specifically, cytochrome DNA testing, which provides information with regards~     to participant specific metabolism of medications, will be used in the evaluation of~     participant medication regimens. The overall aim of the project is to evaluate if the~     addition of genetic CYP testing to a standardized MTM Program provides increased clinical~     value. To answer this question, the investigators will look at the drug therapy problems~     (DTPs) identified by the genetic test compared to those DTPs discovered without the test.~   "
86972|NCT02428647|"~     The study will be conducted as a community-based, randomized, placebo-controlled, trial with~     four study groups. The overall objective of the study is to determine the optimal method for~     delivering zinc to young children, both for the prevention of zinc deficiency and treatment~     of diarrhea. In particular, the investigators plan to compare the impact on physical growth,~     morbidity, micronutrient status, immune function, environmental enteric dysfunction, parasite~     burden and hair cortisol concentration of: 1) daily preventive zinc supplementation as a~     micronutrient powder (MNP); 2) placebo powders; 3) daily preventive zinc supplementation as~     dispersible tablets; 4) therapeutic zinc supplementation as dispersible tablets given in~     relation to episodes of diarrhea.~      In addition to the major outcomes mentioned above, the investigators will monitor adherence~     to the interventions, neuro-behavioral development, and the occurrence of any adverse events.~   "
86973|NCT02428634|"~     The objective of the study is to evaluate the effects of Program SI! for Elementary in~     different times of exposure for childrens and their immediate environment (teachers and~     parents). For this purpose, 48 public schools from the Community of Madrid-South Area (Spain)~     were randomly assigned to Program SI! during 3 or 6 academic years (intervention group) or~     keep their normal curriculum (control group). The main outcome is 3-year, and 6-year changes~     from baseline of questionnaire scoring of children, their parents and teachers in regards to~     a healthy lifestyle. For children were included 3-year, and 6-year changes of cardiovascular~     markers derived from blood pressure and anthropometry.~   "
86974|NCT02428621|"~     The aim of this prospective, multicentric, randomized, open-label study is to assess the~     efficacy of the removable Twicare® as mandibular propulsive appliance in children aged from 7~     to 12 years old in the course of their orthodontic treatment, showing its noninferiority with~     the removable Herbst. One untreated group will be included to control the internal validity~     of the study as recommend in noninferiority trials. Patients will have a follow-up every two~     months during 6 to 12 months as planned in routine care.~   "
86975|NCT02428608|"~     The primary objective is to demonstrate the safety of multiple doses of DWP-450 purified~     Botulinum neurotoxin, Type A, in treatment of moderate to severe glabellar lines associated~     with corrugator and procerus muscle activity in adult subjects.~   "
86976|NCT02428595|"~     Multi-center, prospective, within-subject control, open label clinical trial to evaluate the~     durability of the safety and effectiveness of the Eclipse™ System after 3 and 12 months of~     use.~   "
86977|NCT02428582|"~     To compare the outcome of revascularisation the gastrointestinal arteries using covered~     stents compared to bare-metal stents in patients with CGI.~   "
86978|NCT02428569|"~     This study evaluates the effectiveness of patient educational materials (a book and DVD) to~     help patients with chronic kidney disease make early, shared, and informed decisions about~     kidney replacement therapy. Half of the participants will receive the educational materials~     and half will receive usual care from their doctors.~   "
86979|NCT02428556|"~     OBJECTIVE: To learn how people understand language used by the FDA to describe certain newly~     approved medications called breakthrough drugs.~      BACKGROUND: FDA allows drugs to be designated as breakthrough if there is preliminary~     evidence that it may offer a substantial improvement over available therapies. But consumers~     (and prescribers) may mistake the word — which in this context means very preliminary promise~     and lots of uncertainty - to mean the drug is proven to be much more effective or much safer~     than existing drugs.~      METHODS: Internet survey (with colleagues from Carnegie Mellon University) using Amazon~     Mechanical Turk - a web tool that recruits people willing to do surveys~     (https://www.mturk.com/mturk/welcome). Participants will be asked to read a short scenario~     about a new drug (facts are based on a real drug but the investigators use a fictional name)~     and answer questions about how well they think the drug works, how safe it is, etc. People~     will be randomized to one of 5 versions of the scenario differing in how explicitly they~     explain what breakthrough means. The information in the scenario is drawn from FDA's own~     press release about the drug.~   "
86980|NCT02428543|"~     This project is part of a joint ALFA and GOELAM strategy aiming to improve the survival of~     patients with newly diagnosed Acute Myeloid Leukemia (AML) aged 18-70 years. The basis of~     this strategy is to evaluate intensified conventional chemotherapy and targeted drugs in~     selected disease-risk subgroups of adult patients with non promyelocytic AML. Participation~     will be proposed to almost all adult patients in France aged 18-70 years and diagnosed with~     AML.~      FLT3 genetic alterations include FLT3 somatic point mutations within the second tyrosine~     kinase domain and internal duplications of the juxta-membrane domain. This alteration is~     refered to as FLT3-ITD. The FLT3-ITD mutation is found in around 30% of patients with~     cytogenetically normal AML. Patients with the FLT3-ITD genotype have been reported to have a~     poor outcome when treated with conventional chemotherapy with an estimated 4-year~     relapse-free survival of 25% (Schlenk et al. N Engl J Med 2008). More recently, the~     prognostic relevance of FLT3-ITD has been studied in the context of integrated genetic~     profiling. This confirmed the genetic complexity of AML and also that FLT3-ITD was associated~     with reduced overall survival in intermediate-risk AML. A multivariate analysis of several~     genetic alterations revealed that FLT3-ITD was the primary predictor of patient outcome.~     FLT3-ITD mutations were classified in 3 categories: 1) FLT3-ITD with +8, TET2, DNMT3A or~     MLL-PTD mutations (3-year OS 14.5%); 2) FLT3-ITD with wild type CEBPA, TET2, DNMT3 and~     MLL-PTD (3-year OS 35.2%) and 3) FLT3-ITD with CEBPA mutations (3-year OS 42%) (Patel JP et~     al. N Engl J Med 2012). However, FLT3-ITD was not a predictor of response to induction~     therapy, allowing the introduction of targeted therapies after the induction course.~      Several FLT3 inhibitors have been evaluated or are currently being tested in the setting of~     relapsing AML. In most trials to date, patients were only eligible if the FLT3-ITD mutation~     was present. Disappointing results were reported with the first generation of FLT3~     inhibitors, including lestaurtinib (CEP-701), midostaurin (PKC-412) and sorafenib. Second~     generation FLT3 inhibitors such as quizartinib (AC220) are currently under investigation with~     promising results. However, the hematologic toxicity of AC220 will likely present a major~     limitation in evaluating AC220 combined with standard or high-dose chemotherapy.~      Ponatinib (AP24534) is a third generation tyrosine kinase inhibitor targeting the BCR-ABL~     tyrosine kinase domain. Ponatinib was rationally designed with an extensive network of~     optimized molecular contacts and triple bonds to accommodate the T315I mutation, a major~     cause of resistance to tyrosine kinase inhibitors in chronic and advanced phase chronic~     myelogenous leukemia (CML). Ponatinib also inhibits SRC (IC50: 5.4 nM) and members of the~     VEGFR, FGFR, and PDGFR families of receptor tyrosine kinases (O'Hare T, Cancer Cell 2009).~     Despite low activity against FLT3 based on the IC50 value (FLT3 IC50: 12.6 nM compared to BCR~     IC50: 0.37 nM), ponatinib has recently been reported to have significant cellular activity~     against the MV4-11 cell line which harbors an FLT3-ITD activating mutation. Ponatinib-induced~     apoptosis was maximal at 10 nM in vitro and a single dose of 5 and 10 mg/kg had a strong~     inhibitory effect in vivo in mice bearing MV4-11 xenografts. Primary blast cells from 4~     FLT3-ITD AML patients were also tested and ponatinib reduced their viability (IC50: 4 nM)~     whereas no activity was shown on FLT3-ITD-negative blast cells (Gozgit JM et al. Mol Cancer~     Ther 2011).~      Preliminary data from the phase I clinical trial showed that 15 mg ponatinib was associated~     with a Cmax of 51.1 nM. Cmax was increased to 111 nM and 149 nM in the 30 mg and 45 mg~     cohorts respectively. The trough concentrations were 55.3 nM and 61.9 nM for the 30 mg and 45~     mg doses respectively (Ariad clinical investigator's brochure, version 3). Results from the~     ongoing phase II trial in CML patients suggest that the hematological toxicity profile of~     ponatinib is comparable with that of nilotinib or dasatinib, both of which have been~     successfully combined with conventional chemotherapy.~      Investigators thus aim to combine ponatinib with cytarabine in FLT3-ITD AML patients in first~     complete remission.~   "
86981|NCT02428530|"~     This study assessed the relationship between pregnant women, partner support, and cigarette~     and alcohol use in pregnancy.~   "
86982|NCT02428517|"~     This study is a prospective multicenter observational study to evaluate the feasibility and~     the efficacy of the conditioning regimens which are modified by the donor differences and the~     age of recipients among patients who will receive allogeneic hematopoietic stem cell~     transplantation in their 1st or 2nd hematologic complete remission (CR).~   "
86983|NCT02428504|"~     It is not universal that terminally ill patients choose surrogate in the event of~     disagreement between the treating physician and the surrogate at the end of their lives.~     There are several factors that influence the terminally ill patient's decision to choose a~     decision maker at the end of his / life.~   "
86984|NCT02428491|"~     The purpose of this study is to describe the immunogenicity and safety of Sanofi Pasteur's~     DTaP-IPV-Hep B-PRP-T fully liquid combined hexavalent vaccine (Hexaxim®) administered at 2,~     3, and 4 months of age and at 16 to 17 months of age in infants and toddlers who received a~     dose of Hep B vaccine at birth or within 1 week after birth.~      Primary Objective:~        -  To describe the safety profile after each and all doses of Sanofi-Pasteur's DTaP-IPV-Hep~          B-PRP-T combined vaccine in Vietnamese infants and toddlers~      Secondary Objective:~        -  To evaluate the immunogenicity of the study vaccine one month after the third dose~          primary series.~        -  To demonstrate the non-inferiority of the immune response to all antigens induced by the~          study vaccine in Vietnamese infants one month after the third dose in a 3 dose primary~          series with the immune response to all antigens induced by the same study vaccine~          outside Vietnam~        -  To describe the persistence of all antibodies before receipt of the booster vaccination.~   "
86985|NCT02428478|"~     Obstructive sleep apnea (OSA) is common and has major health implications but treatment~     options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle~     activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared~     to normal participants. Until recently, the search for medicines to activate pharyngeal~     muscles in sleeping humans has been discouraging. However, exciting new animal research has~     shown that drugs with noradrenergic and antimuscarinic effects can restore pharyngeal muscle~     activity to waking levels. In this protocol the investigators will test the effect of~     desipramine (a tricyclic antidepressant with strong noradrenergic and antimuscarinic effects)~     on genioglossus muscle activity (EMG GG) during sleep in healthy control participants.~   "
86986|NCT02428465|"~     Pediatricians' provision of parenting-focused anticipatory guidance often does not meet~     parents' needs; the few studies that have investigated primary-care based strategies to~     promote positive parenting rely on time-intensive, high-cost interventions, thereby limiting~     their generalizability. Therefore, the Purposeful Parenting was developed as a universal~     program of enhanced anticipatory guidance. At each well-child visit in the first year of a~     child's life, Purposeful Parenting provides parents with: 1) scripted anticipatory guidance~     and handouts focused on the child's emerging social-emotional and linguistic (SEL) skills,~     brain development and the importance of responsive parenting; and 2) a reminder item (e.g.,~     a Smile at Me onesie) that allows for in-office role modeling and promotes practicing of an~     age-specific, nurturing parent-child interaction. If an in-office intervention is missed~     (e.g. parent cancels visit, interventionist out sick) the intervention will be delivered by~     telephone if possible by the site-based clinical interventionists and the reminder items~     will be mailed.~   "
86987|NCT02428452|"~     The Social ABCs is an innovative parent-mediated intervention for toddlers with confirmed or~     suspected Autism Spectrum Disorder (ASD). The intervention draws on what is known about core,~     early emerging impairments in ASD, and on evidence-based Pivotal Response Treatment (PRT) and~     associated parent training programs for enhancing development in children with ASD.~     Completion of a comprehensive pilot study set the stage for a randomized control trial (RCT)~     of the Social ABCs. The purpose of this RCT is to evaluate the efficacy of the Social ABCs~     intervention program on improving spoken language skills and positive parent-child emotion~     sharing in toddlers with signs of or a diagnosis of ASD.~   "
86988|NCT02428439|"~     The objective of this study is to identification of genetic markers and predictors of~     antidepressant-induced suicidality in youth depression. Participants who take the~     standardized pharmacotherapy (bupropion or lamotrigine) for depression will be observed for 8~     weeks. They will do several scales and genetic tests at visit 1 (week 0), visit 3 (week 4)~     and visit 4 (week 8)~   "
86989|NCT02428426|"~     To investigate the mucosal microbiome in human gastric intestinal etaplasia and duodenal~     tissue.~   "
86990|NCT02428413|"~     The purpose of this study is to evaluate anesthetic gas in the PACU within patient and~     caregiver breathing zones.~   "
86991|NCT02428400|"~     Methodology:~      This is a double-blind, randomized, placebo-controlled, multi-cohort Phase 1/1b study in~     patients that are currently being treated for chronic HBV infection. For all cohorts,~     patients must be receiving antiviral treatment with either tenofovir disoproxil fumarate~     (TDF) or entecavir (ENT) for at least two years, and have their HBV infection well-controlled~   "
86992|NCT02428387|"~     With the number of Canadians with Alzheimer's disease and related dementias (ADRD) growing,~     supporting family care partners of persons with ADRD is critical. Family caregivers provide~     about 90 per cent of in-home care for persons with ADRD, and the care is often difficult due~     to co-morbidities in persons with ADRD. Family caregivers of older persons with ADRD and~     multiple chronic conditions (MCC) experience significant, complex, distressing transitions~     such as changes to their environment, roles and relationships, physical and mental health,~     isolation, and taking on new tasks. An online Transition Toolkit (My Tools 4 Care) was~     developed for family caregivers of persons with ADRD and MCC living at home, to support~     caregivers through transitions and increase their self-efficacy, hope, and quality of life~     (QOL).~      Through this pragmatic mixed methods randomized controlled trial the investigators expect to~     find that family caregivers receiving the online My Tools 4 Care Toolkit will show greater~     improvement in hope, self-efficacy and QOL, at no additional cost from a societal~     perspective, compared with those in an educational control group. Following baseline data~     collection 180 participants will be randomly assigned to one of the groups with repeated~     measures at one, three and six months.~   "
86993|NCT02428374|"~     The fascinating role of lymphocyte subtypes in the development of coronary artery disease may~     be a new strategic target for understanding and therapy of acute myocardial infarction. The~     determinants of cell viability are unknown, postulating that they arise from factors not only~     related to microcirculation or energy expenditure, but also to inflammatory and immune~     responses. Furthermore, the intense mobilization of progenitor cells secondary to myocardial~     infarction triggers large lymphocyte proliferation that colonizes plaques in development,~     contributing to recurrent ischemic outcomes. This project aims to evaluate the immune and~     metabolic mechanisms involved in the recovery of the ischemic myocardium and coronary disease~     progression.~   "
86994|NCT02428361|"~     This is a prospective, open label pilot study in which patients with symptoms of acute or~     chronic pouchitis will receive FMT therapy delivered via pouchoscopy. The investigators~     hypothesize that FMT is a safe and effective treatment for patients with pouchitis. Our aims~     our:~        1. To determine if symptoms of pouchitis can be successfully treated by Fecal Microbial~          Transplantation.~        2. To determine if endoscopic appearance of ileal pouch improves following treatment by~          Fecal Microbial Transplantation.~   "
87008|NCT02428179|"~     Surgical site infection (SSI) is the most frequent complication in patients that undergo~     abdominal surgery. A previous prospective observational study in 167 patients undergoing~     elective open abdominal procedures showed that case-relevant communication protects from~     organ/space SSI whereas case-irrelevant communication during the last 20 minutes of the~     procedure is a risk factor for incisional SSI. Therefore, the introduction of a clinical~     applicable intervention structured briefing using the StOP protocol has been developed and~     was tested in pilot experiments. This intervention aims at improving case-relevant~     communication during the procedure and to reduce excess case-irrelevant communication at the~     end of an operation.~      The hypothesis is: structured briefings during an operation reduce the incidence of SSI after~     surgery.~   "
86995|NCT02428348|"~     The goal of this project is the development of an EEG-cap (min. 21 electrodes) with~     user-friendly active dry electrodes that meets the expectations of the users regarding~     comfort and esthetics, without losing sight of the functional and technical demands for~     recording high quality EEG signals. The purpose is to use the EEG-cap to investigate clinical~     neurological disorders (e.g. epilepsy). The EEG-cap could also be used at home so that~     hospital admission in the EMU can be avoided for some patients and an increasing number of~     patients can be examined.~      Phase 3 of this Project will be divided into Phase 3a and Phase 3b.~      In Phase 3b of the project epilepsy patients and their family will be interviewed about~     different EEG-cap models in development. This interview is anticipated to take approximately~     1 hour.~      Minimum 4 - maximum 20 epilepsy patients and their family will be interviewed.~      The results of the interviews will be analysed by the design company pilipili nv.~   "
86996|NCT02428335|"~     Sunitinib is a chemotherapy approved by the FDA as a standard of care treatment for renal~     cell carcinoma (RCC). Fatigue is a very common side effect of sunitinib that frequently~     causes dose reductions. The cause of this fatigue remains unclear. This study will use a~     special type of scan to study sunitinib-induced fatigue in relation to exercise.~   "
86997|NCT02428322|"~     Epidemiological and observational studies have linked vitamin D deficiency with increased~     asthma/allergy incidence . Vitamin D insufficiency (<75nmol/L) has been associated with~     increased incidence of severe childhood asthma. Further, high 25(OH)D levels were associated~     with reduced risk of recent hospitalization, lower use of anti-asthmatic medication and lower~     airway hyper-responsiveness in childhood asthmatics. The association between vitamin D and~     allergy and asthma appears to be stronger in children than adults, with some even suggesting~     that childhood asthma may may be caused by VDD.~   "
86998|NCT02428309|"~     The primary purpose of this Phase 1 study is to evaluate the safety, tolerability, and effect~     of 3 different doses of Treg therapy in adults with skin (cutaneous) involvement of their~     lupus. Targeting cutaneous disease offers the ability to control background therapy, readily~     detect clinical effects, and perform research analyses not only in blood but also skin.~     Safety, disease activity, and mechanism of Tregs will be evaluated. The intent is to support~     dose selection for a future larger efficacy trial in lupus.~   "
86999|NCT02428296|"~     Background:~      - PIK3CA-related overgrowth spectrum (PROS) is caused by changes in the PIK3CA gene. This~     gene makes a protein that communicates with other proteins in the body to cause cells to~     grow. Alterations in PIK3CA change the chemical signals in the body and cause overgrowth in~     fatty, vascular and other tissues. Sirolimus is a drug that reduces the signals sent by one~     of the proteins in this chemical signaling pathway. Researchers want to learn whether the~     drug sirolimus can reduce or stabilize some of the overgrowth that patients with PROS~     experience.~      Objectives:~      - To measure how the overgrowth of patients with PROS changes over time and whether taking a~     drug called sirolimus can reduce or stabilize a person s overgrowth.~      Eligibility:~      - People ages 3 to 65 years old with a confirmed mutation or alteration of the PIK3CA gene in~     the person s affected tissues (a somatic mutation).~      Design:~        -  Participants will be screened with medical history and genetic counseling.~        -  First 6 months: Participants will have their overgrowth monitored.~        -  Next 6 months: Participants will take sirolimus once or twice a day.~        -  Participants will have to visit the clinic several times, and stay in the area for 4 5~          days each time.~        -  Participants will have a one month-long visit to the clinic.~        -  During clinic visits, participants will have:~        -  Blood and urine tests.~        -  Photographs of their physical features.~        -  Scans, including an MRI and DEXA, and possibly x-rays and CT scans.~        -  For the MRI and CT scans, participants will lie in a machine that takes pictures of~          their body.~        -  The DEXA involves a small amount of radiation.~        -  They may have:~        -  Non-invasive heart function tests.~        -  Lung function tests.~        -  Participants will have several blood and urine tests between visits.~        -  Participants will complete surveys and keep a diary of their treatment and side effects.~        -  Participants may visit other health specialists or undergo other tests based on side~          effects.~        -  One month after stopping the study drug, participants will have 1 clinic visit.~   "
87000|NCT02428283|"~     Emergence agitation is a common problem in children during recovery from sevoflurane~     anesthesia. Pain is considered as a cause of postoperative emergence agitation and~     compounding factor of agitation assessment in children. The purpose of this study was to~     investigate the effect of scalp nerve block on the emergence agitation in children undergoing~     nevus surgery during sevoflurane anesthesia.~   "
87001|NCT02428270|"~     This is a phase 2 study (the second phase in testing a new drug or combination to see how~     effect the drug or combination is) of investigational drugs GSK2256098 and Trametinib.~      The purpose of the study is to evaluate the antitumor activity of GSK2256098 and Trametinib~     in patients with advanced pancreatic cancer.~   "
87002|NCT02428257|"~     The study evaluates the potential beneficial effects on hemodynamics when hypobaric~     bupivacaine is used instead of isobaric bupivacaine in continuous spinal anesthesia for~     surgical repair of hip fracture in elderly patients. Half of the patients will receive~     hypobaric bupivacaine and the over half will reveive isobaric bupivacaine and hemodynamic~     data will be compared.~   "
87003|NCT02428244|"~     It is well known that smoking has deleterious effects to fracture/broken bone outcomes.~     Complications associated with smoking can be mitigated by smoking cessation. Initiating~     smoking cessation programs while patients are in the inpatient hospital setting has shown to~     be an opportune time to enroll patients in a smoking cessation program. The goal of this~     study is to determine if inpatient smoking counseling with/without follow-up is superior to~     the standard smoking cessation information associated with admission to a hospital facility.~   "
87004|NCT02428231|"~     The primary objective of the study is to assess whether a 6-week titration (compared with a~     1-week titration) is effective in reducing the incidence of dimethyl fumarate (DMF~     [Tecfidera])-related gastrointestinal (GI) adverse events (AEs) in participants with multiple~     sclerosis (MS). The secondary objective of this study is to assess whether a 6-week titration~     (compared with a 1-week titration) is effective in reducing the average severity and duration~     of GI symptoms over 12 weeks of DMF treatment in this study population.~   "
87005|NCT02428218|"~     The primary objective of the study is to assess the efficacy of oral BG00012 as compared with~     placebo in pediatric subjects with relapsing-remitting multiple sclerosis (RRMS). The~     secondary objectives of this study are to evaluate the safety and tolerability of BG00012 and~     to compare the effect of BG00012 with placebo on additional clinical and radiological~     measures of disease activity.~   "
87006|NCT02428205|"~     The purpose of this study is to explore the effects of propranolol in combination with early~     intensive behavioral intervention on social interaction, and secondarily on language,~     anxiety, adaptive behaviors, and global function in children with autism in a double-blinded,~     placebo-controlled pilot trial.~   "
87007|NCT02428192|"~     This phase II trial studies how well nivolumab alone or in combination with ipilimumab works~     in treating patients with uterine cancer that has spread to other places in the body and~     usually cannot be cured or controlled with treatment. Monoclonal antibodies, such as~     nivolumab and ipilimumab, may interfere with the ability of tumor cells to grow and spread.~   "
87009|NCT02428166|"~     The purpose of this retrospective study is to assess corneal changes (keratometry,~     pachymetry) and change in visual acuity (VA) in keratoconus patients after unilateral~     crosslinking treatment compared to the untreated fellow eye. The corneal measurements~     obtained preoperatively and 2 to 14 months postoperatively using a Pentacam rotating~     scheimpflug camera are analyzed. Furthermore, pre-existing or actual ocular pathology or/and~     ocular surgeries as potential factors involved in treatment outcome are also evaluated.~   "
87010|NCT02428153|"~     The purpose of this study is to investigate the acute effects of two different types of~     muscle stretching (static and dynamic) on muscle-tendon unit of gastrocnemius muscle by~     ultrasound and to follow how long the stretching effects are sustained.~   "
87011|NCT02428140|"~     The overall aim of this trial is to determine the most cost effective approach to diagnose~     paroxysmal atrial fibrillation (PAF) following transient ischemic attack (TIA) and stroke.~      A summary of the rationale for this study is as follows:~        1. Recently completed randomized trials of cardiac monitoring following stroke have~          established that PAF is more common than previously recognized in cryptogenic stroke.~        2. The majority of TIA/stroke patients will have at least one potential stroke mechanism~          identified by the time etiologic investigations completed.~        3. Detecting PAF in patients with strokes with known causes (eg. lacunar and large vessel~          atherosclerosis) is clinically important since appropriate anticoagulation for AF~          reduces stroke recurrence in all patients with prior TIA/stroke not just cryptogenic~          strokes.~        4. There are competing technologies for evaluating cardiac rhythm and diagnosing AF but no~          cost effectiveness data~        5. The rates of PAF in strokes with known causes (SKC) have not been well characterized.~      PER-DIEM is a pilot study to compare two different cardiac monitoring technologies as first~     line investigations to detect PAF in patients with recent stroke and TIA. The study will also~     assess whether a pivotal trial is feasible and warranted.~      The principal research questions to be addressed in this study will be:~        1. What is the relative cost-effectiveness as a first line investigation of long-term~          implantable ECG (ILR) coupled with remote monitoring for 12 months compared to external~          event-triggered ECG loop recorder (ELR) for 30 days in the diagnosis clinically~          actionable AF in following TIA/stroke.~        2. What is the feasibility, patient compliance, diagnostic accuracy and rates of AF~          detection (>30 seconds) of ILR compared to the ELR strategies.~   "
87012|NCT02428127|"~     The purpose of this study is to investigate the impact of a beverage containing carbohydrate~     powder fortified with micronutrients on agility, speed, and power in school going children~   "
87013|NCT02428114|"~     In patients with early-stage breast cancer, chemotherapy has substantially improved survival~     rates for breast cancer patients. Improvements in outcomes, however, are compromised by the~     considerable toxicities associated with chemotherapy, most notable being neutropenia.~     Neutropenia is the presence of abnormally few white blood cells, leading to increased~     susceptibility to infection and can require hospitalization and need for intravenous~     antibiotics and is sometimes fatal. Febrile neutropenia can also be associated with treatment~     delays and dose reductions, potentially compromising treatment efficacy. Patients can receive~     medication to reduce the risk of febrile neutropenia, such as Neupogen (Filgrastim) as a~     daily injection for 5, 7, or 10 days. Since there is genuine uncertainty amongst healthcare~     professionals as to which administration schedule of Neupogen is better, investigators are~     performing a randomized study in which patients are put into a group by chance to give~     participants one of three standards of Neupogen daily injection. Neupogen can cost~     approximately $200 per injection, so if a physician prescribes 10 days for 8 cycles of~     treatment this can cost $16,000 compared to a 5 day prescription which would cost half this.~     In addition to cost savings, many patients are not able to give themselves injections on a~     daily basis and require nursing resources which are utilized at high-cost. This study will~     use an integrated consent model that involves an oral consent rather than a written~     informed consenting process in order to increase the number of patients who may participate~     while performing a study at a lower cost. While determining the optimal treatment will~     improve patient comfort and acceptability, using the minimal safe duration of administration~     may also offer cost savings.~   "
87014|NCT02428101|"~     This study will examine DNA from Gastrointestinal Tract of cancer patients treated with~     oxaliplatin to look for a variation (mutation) of the ABCG2 gene that may lead to~     drug-induced peripheral neuropathy in certain patients.~      The DNA will be extracted from patients' blood samples and are analyzed for the ABCG2 single~     nucleotide polymorphism (G34A - rs2231137 ,C421A-rs2231142 , A/A -rs3114018 genotypes) and~     correlated with peripheral neuropathy grades.~   "
87015|NCT02428088|"~     This is a 6 week efficacy and safety study of Dasotraline in subjects 6 to 12 years old with~     ADHD.~   "
87016|NCT02428075|"~     Hypertension contributes to significant burden of cardiovascular diseases (CVDs) in low and~     middle-income countries; however responses to CVDs are inadequate particularly due to lack of~     conclusive evidence on population based approach to hypertension control. This is a community~     based cluster randomized trial involving family based health education through female~     community health volunteers in Nepal. People ≥25 years of age and who are listed in the voter~     list 2006 of Electoral Commission of Nepal who were either hypertensive, pre-hypertensive or~     normotensive are eligible for eligible for participation in the study. A computer generated~     random codes will be used to divide clusters into treatment and control arm. FCHVs will~     conduct family based health education and blood pressure measurements in the treatment arm vs~     not any interventions in control arm. Independent assessors will conduct the baseline and end~     line assessment of the intervention. Intention to treat analysis and per protocol analysis~     will be used in analysis to detect significant differences between treatment and control~     group participants at baseline and follow up. Student t-tests for normally distributed~     variables and chi-squared tests for categorical variables will be used. In the event that~     randomization do not control for differences between the treatment and control groups on~     baseline characteristics, the investigators will statistically control for those differences~     in subsequent analysis of program effects. The final outcome will be modeled by using~     multiple linear regressions analysis. The investigators hope that if the intervention~     outcomes shows positive effects in treatment arm, this approach can be adopted into the~     existing health care delivery system in Nepal. Assessing the FCHVs' ability may further~     contribute to developing a policy that can be scaled-up to a national level. The lessons~     learned from this project may also be replicated in rural areas and similar settings~     elsewhere in the world.~   "
87017|NCT02428062|"~     BACKGROUND: Post-operative cognitive dysfunction (POCD) is a potentially irreversible loss of~     brain functions observed in elderly patients after surgical operations under general~     anaesthesia. POCD at 3 post-operative months is observed in up to 15% of patients aged 70~     years and more, and the only recognized risk factor for this condition is increasing age.~     Importantly, the incidence of POCD at 3 months has been associated to an increased disability~     and mortality.~      OBJECTIVES: The present study will evaluate in patients aged 75 years and older undergoing~     general anaesthesia for non-cardiac surgery, whether an hemodynamic strategy, aiming at~     maintaining intra-operative arterial blood pressure close to patient's preoperative blood~     pressure, i.e., to avoid hypotensive episodes, reduces the incidence of POCD at three months.~      METHODS: Around 1800 consecutive patients scheduled to undergo general anaesthesia for~     elective non-cardiac surgery will be enrolled. Each patient's cognitive function will be~     evaluated preoperatively and at 3 months and 1 year postoperatively, together with the~     occurrence of hearing loss and vestibular function impairment. Furthermore, the incidence of~     postoperative delirium and cardiovascular, respiratory and infectious complications will be~     evaluated.~      EXPECTED RESULTS: The primary outcome is a 25% relative reduction in the incidence of POCD at~     3 postoperative months. Secondary outcomes are the reduction of POCD incidence at 1~     postoperative year, a reduction in postoperative hearing loss and vestibular impairment at 3~     months, a reduction in the incidence of delirium. Hospital length of stay and 90 day~     mortality will also be assessed. This present study could have a high socio-economic impact,~     reduce healthcare costs and patient morbidity and mortality with a simple not expensive~     intraoperative intervention.~   "
87018|NCT02428049|"~     The investigators want to:~        1. Assess whether curative radiotherapy for lung cancer leads to permanently reduced lung~          function~        2. To assess the predictive value of pulmonary function tests for the development of a~          permanent reduction in lung function after curative radiotherapy~        3. To assess the predictive value of genetic markers for permanently reduced lung function~          after curative radiotherapy~   "
87019|NCT02428036|"~     The purpose of this study is to determine whether TBI-1401(HF10), a spontaneously attenuated~     mutant of Herpes Simplex Virus Type 1 (HSV-1), is safe and tolerable in the treatment of~     solid tumors with superficial lesions.~   "
87020|NCT02428023|"~     Our purpose is to investigate whether thallasaemia trait offers protection against~     cardiovascular events and whether this can be applied to specific characteristics of these~     people ( better lipid profile , better blood pressure profile) as scientific literature~     suggests.~   "
87021|NCT02428010|"~     Study to evaluate the safety and performance of the Twelve TMVR System~   "
87022|NCT02427997|"~     A prospective, randomized controlled single-blind trial will test the hypotheses that a 6-~     week intervention that combines treadmill training (TT) with virtual reality (VR)~     significantly improves real-life, functional mobility and cognitive abilities, keys to~     health-related quality of life in patients with MS.~   "
87023|NCT02427984|"~     During last 6 years approximately 10.000 ceramic balls and 5.000 ceramic liners have been~     implanted in the region Emilia-Romagna in Italy (4 million Every single year approximately~     60.000 hip prostheses are implanted in Italy. Quality of life of patients after surgery is~     very good, as widely demonstrated in the literature. On the basis of data produced by the~     only complete hip register in Italy that is run in our Lab (RIPO, Register of Orthopedic~     Implants in the Region Emilia-Romagna) survival rate of primary total hip prosthesis is 95.6%~     at 9 years. Reasons for revision are mainly aseptic loosening of one or both components (40%~     of the total) and dislocation (26%), being the latter much more frequent in the first two~     years. Less frequently revision is due to sepsis (7% of the total),bone fracture (11%),~     prosthesis fracture (3%) or pain (3%). Revision is relates, among the others, to~     prosthesis-related factors, such as fixation to bone and articular coupling. In our~     experience, during the last ten years 32% of implants had both articular component in ceramic~     , 34% had metal head and plastic liner, 24% ceramic head and plastic liner, 10% both~     components in metal.~      Each solution has strengths and weakness and they have been identified and clinically applied~     in order to overcome step by step limitations observed in the previous one. The most recent~     are the hard-on-hard bearings, that is ceramic on ceramic and metal on metal. These two~     solutions, beside very promising results on wear resistance, show some peculiar failures:~     respectively fracture of the ceramic component and hypersensitivity induced by metal ions.~      Aim of research proposal is to investigate two uncommon and less investigated early symptoms~     of failure:~        -  'noising hip' in ceramic on ceramic total hip arthroplasty~        -  pain without radiographic signs of loosening in metal on metal total hip arthroplasty~          These two situations are extremely relevant, as they prelude to a failure of the~          prosthesis. If clearly identified they could represent a powerful tool in early~          diagnosis of pending failure To reach this goal our patients wearing hard-on-hard total~          hip arthroplasty, suffering for described symptoms will undergone a specific diagnostic~          procedure.~      The first group will be studied through CT scan of the patients to evaluate impingement or~     instability of the prosthesis, and a needle aspiration for synovial fluid. The fluid will be~     examined to identify ceramic wear debris, according to a method of separation and analysis in~     scanning electron microscopy that was set in our Lab.~      Sound will be recorded by means of a wearable sensor set capable of recording the articular~     noise produced during level walking. This instrumentation will be coupled to motion analysis~     technology.~      This would make possible a diagnostic approach able to correlate the involved factors to~     clinical occurrences, on the basis of the recorded frequencies.~      -Second group will be studied through the dosage of circulating ions, deriving from the~     articular surfaces and through the histological classification of vasculitis in periimplant~     tissues. There is increasing evidence, indeed that locale release of submicron particles worn~     out from articular surfaces can release metal ions (mainly Chromium and Cobalt) responsible~     for lymphocyte local infiltration. In particular CD20 positive B lymphocyte and CD3 positive~     T lymphocyte and sometimes CD68 positive plasma cells are present. The cells could justify~     the development of pseudotumors in metal-on metal hip prosthesis.~      Data collected from patients matched to in vitro results will allow us to to avoid or at~     least propose a more appropriate timing for revision surgery.~   "
87024|NCT02427971|"~     The Aysis® Cs2 ventilator offers an automated control of end-tidal inhalation anesthetic~     concentration, the EtControl® mode. A low Fresh Gas Flow (FGF) (0.5L/min) is kept during the~     maintenance of the anesthesia, decreasing the expensive consumption of halogenated agents.~      The Perseus® A 500 offers a VaporView® mode that gives the evolution of inspired (Fi) and~     end-tidal (Fe) fractions of halogenated agents for 20 minutes based on the delivered fraction~     (Fd). FGF remains adjusted manually by the practitioner. This mode also makes it possible to~     maintain a low FGF (0.5 L/min), provided the halogen Fd is set to maintain a steady Fe curve.~      The goal of this work was to compare the maniability of the intraoperative administered~     concentrations and the consumption of Desflurane between these 2 modalities of~     administration.~   "
87025|NCT02427958|"~     The purpose of this study is to assess long-term safety and efficacy of leuprorelin in the~     treatment of Central Precocious Puberty (CPP).~   "
87026|NCT02427945|"~     The investigators are seeking to overcome the dual challenges of under-nutrition and diarrhea~     using an existing safe water supply platform to deliver nutrition information to targeted~     groups in Western Kenya. Using a randomized evaluation, investigators will determine the~     impact on nutrition status and practices of delivering nutrition information. The evaluation~     results will enable Evidence Action to make strategic decisions regarding the potential~     scale-up of the combined program across Kenya.~   "
87027|NCT02427932|"~     This study proposes to compare the metabolism of Ampicillin and Gentamicin by pregnant women~     to that of non-pregnant women; the placental transfer over time; and the subsequent~     metabolism of the transferred drug(s) in the neonate.~   "
87028|NCT02427919|"~     Granulocyte Colony Stimulating Factor (G-CSF, filgrastim) is now widely used after~     chemotherapy which complicates hematological toxicity involving neutropenia. As prolonged~     neutropenia leads to neutropenic fever due to bacteremia or fungal infection, the use of~     G-CSF prevents severe infectious complication in various cancer patients.~      In acute myeloid leukemia (AML), leukemic blasts have been expected to have G-CSF receptor~     which may be stimulated by G-CSF, and refractory patients were not treated with G-CSF in~     salvage chemotherapy in Catholic blood and marrow transplantation (BMT) Center for a long~     time. This strategy induced prolonged neutropenia and a lot of infectious complications some~     of which led to deaths.~      Although there are some data which remind us G-CSF may proliferate leukemic blasts, the~     investigators also identified several reports which suggested that subgroup with G-CSF use~     showed acceptable CR rate and improved survival outcomes compared to a subgroup without G-CSF~     use.~      Therefore investigators are now trying to identify the effects of G-CSF for refractory AML~     patients in salvage chemotherapy setting regarding the duration of neutropenia and admission,~     incidence of infectious complications and the duration of antibiotics application.~     Furthermore, overall response rate (CR+CRi) after salvage chemotherapy and survival outcomes~     will be calculated according to G-CSF use.~      Also, investigators will detect G-CSF receptor using cluster of differentiation 114 (CD114),~     and analyze the clinical outcomes according to the subgroups with or without using G-CSF~     during neutropenic period.~   "
87029|NCT02427906|"~     The purpose of this study is to determine the effect of transjugular intrahepatic~     portosystemic shunt on gut microbiota and associated inflammatory factors in cirrhotic~     patients.~   "
87030|NCT02427893|"~     This trial explores the immunologic effects of vemurafenib (BRAF inhibitor) and cobimetinib~     (MEK inhibitor), administered alone and in combination, to patients with advanced BRAF~     V600E/K mutant melanoma.~   "
87031|NCT02427880|"~     The purpose of this study is to determine whether using furosemide following acetazolamide is~     effective in treating refractory edema associated with nephrotic syndrome.~   "
87038|NCT02427776|"~     The purpose of this study is to assess the safety and the preliminary efficacy of a single~     infusion of stimulated autologous CD4+ T cells in patients with Relapsing-Remitting Multiple~     Sclerosis.~      The study duration for the patients (from start of baseline to end of follow-up) is 270 days.~   "
87039|NCT02427763|"~     Thermoplastic devices are used in orthodontic treatment and consists of a series of nearly~     invisible, removable aligners. However, every device used in the mouth can change the buccal~     flora and increase the number of bacterias. This is a risk factor for enamel~     demineralization. The treatment can vary in time of use per day. The patient under~     orthodontic treatment has to use the device for 22 hour each day. When the period of~     retention comes, it is reduced to 8 hours. The investigators want to know if the~     concentration of bacterias in saliva and dental plaque will increase, and if the material can~     cause damage on gingiva.~   "
87136|NCT02426502|"~     Patient failure to take medications as prescribed (medication non-adherence) is now~     identified as an important cause of kidney transplant failure. The availability of new drugs~     that are taken once daily may improve patient adherence compared to older drugs that had to~     be taken twice per day. In this study, patients will be converted to a medication schedule~     where all medications are taken once daily with the goal of improving patient adherence and~     satisfaction.~   "
87032|NCT02427867|"~     Several randomized trials suggested a cardioprotective beneficial effect (eg reduction in~     cardiac troponin release) of remote ischemic preconditioning in cardiac surgery.~      Remote ischemic preconditioning by brief episodes of ischemia and reperfusion in a remote~     organ or vascular territory provides protection from injury by myocardial ischemia and~     reperfusion. In the translation of remote ischemic preconditioning from bench to bedside, the~     first proof of principle and small randomized controlled trials have shown a decreased~     release of myocardial biomarkers after aortic, congenital cardiac, adult valve and coronary~     artery by-pass graft surgery. This reduction in cardiac biomarkers release translated into~     better survival in a recent randomized trial performed in cardiac surgery. No clinical trial~     on remote ischemic preconditioning in non-cardiac surgery setting has been performed so far.~      The investigators study wants to test, for the first time, the hypothesis that remote~     ischaemic preconditioning is effective in reducing cardiac damage in high risk patients~     undergoing non-cardiac surgery. Remote ischaemic preconditioning will be achieved by~     inflation of a blood-pressure cuff to 200 mm Hg to the upper arm for 5 minutes, followed by 5~     minutes reperfusion while the cuff will be deflated. Cardiac troponin will be used as marker~     of cardiac damage. If the results of a reduction in postoperative cardiac troponin release~     and perioperative cardiac ischaemic events will be confirmed in a non-cardiac surgery~     setting, the investigators could improve a strategy to prevent perioperative cardiac~     complication easy to apply, safe and low cost.~   "
87033|NCT02427854|"~     In this study the investigators want to assess complications associated to pregnancy and~     delivery, and interventions used during labor.~      Pregnancy and delivery related complications are a major health problem globally. Events~     during labor such as excessive bleeding, uterine rupture, emergency cesarean delivery; other~     instrumental deliveries and anesthesia problems are situations that potentially may lead to~     severe outcomes for the mother and child.~      Diabetes, anemia and hypertensive disorders may also complicate both the pregnancy and~     delivery.~      Between 60-80% of women delivering their first baby need suturing due to perineal tears~     (tears located to the area between the vagina and anus). Superficial perineal tears rarely~     cause long-term problems, but often lead to pain and discomfort immediately after birth.~     Deeper or severe perineal tears, involving the anal sphincter, may influence the woman's~     quality of life. This is mainly due to long-lasting pain, discomfort and sexual dysfunction,~     and the fact that obstetric anal sphincter tear is the main cause of anal incontinence.~     Recent clinical intervention studies have shown that the incidence of severe obstetric~     perineal tears may be reduced by 50-70% by introducing a bimanual support technique of the~     perineum. In these studies all midwives and gynecologists were trained in the bimanual~     support technique. When it comes to training in new medical techniques in general, some~     studies have shown that use of animated instructions on mobile phones may be a good~     alternative to the more traditional hands-on or bedside teaching methods. In a global~     perspective, it is important to study the efficacy of mobile units for transferring of new~     knowledge, especially for use in resource constrained settings.~   "
87034|NCT02427841|"~     This phase II trial studies how well nab-paclitaxel and gemcitabine hydrochloride followed by~     radiation therapy before surgery work in treating patients with pancreatic cancer that can be~     removed by surgery. Drugs used in chemotherapy, such as nab-paclitaxel and gemcitabine~     hydrochloride, work in different ways to stop the growth of tumor cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. Radiation~     therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving nab-paclitaxel,~     gemcitabine hydrochloride, and radiation therapy before surgery may make the tumor smaller~     and reduce the amount of normal tissue that needs to be removed.~   "
87035|NCT02427828|"~     Failure to recognise deterioration early is a major cause of preventable deaths amongst~     hospital patients. The investigators wish to study whether continuous monitoring of 'vital~     signs' (pulse rate, breathing rate, and blood oxygen saturations) with computer modeled~     alerting to detect patient deteriorations can reduce cardiac arrest rate and critical care~     readmissions from the wards by alerting staff to clinical deteriorations more effectively~     than current paperbased systems.~      Continuous monitoring of 'vital signs' can be achieved in two ways. Continuous monitoring of~     'vital signs' has traditionally been restricted to the bedside because of the need for the~     patient to be connected by wires to the monitor.~      More recently, advances in telemetry (wireless technology) have allowed the development of~     wearable devices which allow patients to mobilise freely, whilst constantly monitoring these~     'vital signs'.~   "
87036|NCT02427802|"~     This is a phase 3, randomized, controlled, blinded, multicenter study conducted in 3 parallel~     cohorts of diabetic patients with at least 1 infected foot ulcer. Patients will be randomized~     to receive 1 of 3 study treatments; systemic antibiotic therapy and standard ulcer care with~     either (A) daily application of a gentamicin-sponge, (B) daily application of a~     placebo-sponge or (C) no-sponge, in the ratio 2:1:1.~      Patients will be treated for approximately 28 days and return to the clinic weekly for safety~     and efficacy assessments. After completing treatment, patients will return to the clinic for~     scheduled follow-up visits approximately 10, 30, 60 and 90 days after treatment is stopped.~   "
87037|NCT02427789|"~     Depression is a disorder that causes major harm to physical health and social life. It~     induces isolation, reduced physical and work capacity and increasing the risk of death. In~     contrast, exercise helps to maintain quality of life, also inducing improvement of cognitive~     functions, stimulation of brain plasticity and resilience, in addition to promoting~     self-esteem and social interaction. The precise mechanisms by which exercise improves~     symptoms of depression are not fully clear, but it is probably multifactorial. In this~     project, the investigators aim to investigate variables that provide additional information~     about biomarkers involved in the pathophysiology of depression and therapeutic response to~     exercise. The investigators expect to find changes in biomarkers associated with potential~     mechanisms of neuroprotection (cytokines, markers of oxidative stress, Brain-derived~     neurotrophic factor (BDNF), cortisol) after exercise program and the role in the therapeutics~     of depression. To evaluate functional assessment indices will be used ergospirometry, a test~     that determines the respiratory, cardiovascular and metabolic activity. Overall, this project~     will help to investigate alternative adjunctive treatments for depression and their~     associated biomarkers with response.~   "
87040|NCT02427750|"~     The present study is designed to evaluate the safety and immunogenicity of trivalent, surface~     antigen, inactivated influenza vaccine in 2 age cohorts: 18 to ≤60 years and ≥61 years.~      For the immunogenicity endpoint the antibody response to each influenza vaccine antigen will~     be evaluated by means of Single Radial Hemolysis (SRH) or Hemagglutination Inhibition (HI) at~     approximately 21 days post vaccination.~      The vaccine composition will be based on the WHO recommended influenza strains for the 2015~     Southern Hemisphere vaccine, and the data from this study are intended to support the use of~     this vaccine in future influenza seasons if the recommended vaccine composition remains the~     same.~   "
87041|NCT02427737|"~     Annually, an estimated 700,000 patients do not complete their scheduled MRI scans because of~     claustrophobia or inability to hold still. Training staffs working in MRI facilities to~     provide Comfort Talk® will enable patients to complete high quality imaging without~     medication, which will increase satisfaction and comfort while reducing sedation risks for~     patients, and increase efficiency and reduce loss of revenue for facilities. The effect of~     such training will be tested at 12 MRI sites in a randomized design. Outcome data will be~     collected for one year.~   "
87042|NCT02427724|"~     This study will conduct a split-face and -body randomized control trial to compare lidocaine~     2.5%/prilocaine 2.5% topical anesthetic (LPTA), lidocaine 7%/tetracaine 7% topical anesthetic~     (LTTA), and placebo vechicle (PV) on patients' pain perceptions with Q-switched 532nm laser~     for the treatment of lentigines and/or photorejuvenation.Subjects will fill out a pain score~     on a visual analog scale (VAS) with 0 being no pain and 10 being most pain after each~     treatment area is completed.~   "
87043|NCT02427711|"~     To investigate if the use of a bipolar sealer for skin and capsula incision results in~     decreased total blood loss and/or less blood transfusion in non-septic knee arthroplasty.~   "
87044|NCT02427698|"~     This is a prospective randomized controlled study comparing the efficacy of cryolipolysis~     versus a combination of cryolipolysis and surgical subcision for the treatment of cellulite.~     The treatment sites are both outer thighs. One outer thigh will be randomized to receive one~     treatment of cryolipolysis, while the contralateral thigh will be assigned to receive the~     combination cryolipolysis plus surgical subcision. A live rating by a blinded dermatologist~     will evaluate the treatment and control areas using a cellulite severity scale at week 0~     (before treatment) and at the 3-month follow up visit.~   "
87045|NCT02427685|"~     The study verifies accuracy of a new pulse co-oximeter in the presence of elevated~     carboxyhemoglobin levels.~   "
87046|NCT02427672|"~     This study investigates the effect of upregulating prefrontal cortex activity on antisocial~     and aggressive behavior and risk factors for such behavior. In the double-blind, randomized~     controlled trial, participants will undergo anodal transcranial direct current stimulation~     bilaterally to the dorsolateral prefrontal cortex or a sham stimulation. During and after~     stimulation, they will complete survey and laboratory measures assessing antisocial and~     aggressive behavior and risk factors for antisocial and aggressive behavior. Heart rate and~     skin conductance will also be measured.~   "
87047|NCT02427659|"~     Using virtual reality as a form of distraction for pain during wound care. Virtual reality~     involves looking into a set of goggles and then moving through a computer-simulated world.~   "
87048|NCT02427646|"~     The present study attempts to fill a critical knowledge gap of BoNT A in tremor management by~     studying the efficacy of IncobotulinumtoxinA (Xeomin®) injection for hand tremor in essential~     tremor and idiopathic Parkinson disease using data regarding composition of tremor obtained~     through sophisticated, yet clinically accessible multi-sensor based kinematic information.~   "
87049|NCT02427633|"~     In resource limited settings, access to one-on-one nursing care and airway protection by~     intubation may be unavailable. Patients with coma but adequate oxygenation are frequently~     cared for on medical wards, and nursed by their family members. The investigators previously~     audited the use of the recovery position in patients with cerebral malaria and found that its~     usage was greatly increased by an educational intervention aimed at patient's caregivers. A~     trend to reduction in coma duration and aspiration pneumonia was also found. Since there is~     no evidence that placing comatose, non-intubated patients in a recovery position improves~     outcome, the investigators plan to conduct a randomised controlled study comparing standard~     care with an educational intervention targeting patients' relatives, teaching them to~     maintain their relative in one of two different recovery positions. With the preliminary~     efficacy and safety data and feedback that this study will provide, the investigators would~     then move to conduct a large multicenter study powered to detect a difference in mortality.~   "
87050|NCT02427620|"~     The goal of this clinical research study is to learn if a combination of ibrutinib and~     rituximab plus the combination of 2 different intensive chemotherapy regimens can help to~     control MCL. The safety of this drug combination will also be studied.~      This is an investigational study. Ibrutinib is FDA approved and commercially available for~     the treatment of patients with MCL. Rituximab is FDA approved for the treatment of~     non-Hodgkin's lymphoma and certain types of leukemia. Using these 2 drugs in combination with~     each other is investigational. All of the drugs in Part 2 are standard of care for the~     treatment of lymphoma.~      Up to 131 participants will be enrolled in this study. All will take part at MD Anderson.~   "
87051|NCT02427607|"~     To evaluate the safety and tolerability of perampanel given as an adjunctive therapy in~     participants with epilepsy. This study will be continued until perampanel is commercially~     available.~   "
87052|NCT02427594|"~     The purpose of this study is to evaluate changes in urine net acid excretion, blood pressure~     and body chemistry that occur when the dietary acid load is lowered by using a drug/dietary~     supplement similar to baking soda. This may be important for patients with kidney disease~     because they may have difficulty removing all of the dietary acid load from the body in the~     urine. Participants with and without kidney disease will be recruited. Each participant will~     be fed a controlled diet for one week with sodium bicarbonate and for one week without sodium~     bicarbonate to evaluate these changes. The investigators will also determine if the effect of~     dietary acid load reduction is different in patients with kidney disease compared to those~     without kidney disease.~   "
87111|NCT02426827|"~     The study is a non-blinded evaluation of the use of cervical spinal cord stimulation (SCS)~     for treatment of patients with Hunt and Hess grade 1-2 subarachnoid hemorrhage and evidence~     of cerebral vasospasm.~   "
87053|NCT02427581|"~     The most important consideration in the design of this clinical trial is to ensure the safe~     translation of the personalized synthetic long peptide vaccine strategy. The Food and Drug~     Administration (FDA) dictates that initial studies of biologic therapies be performed in such~     a way that there is a balance between the potential risks and benefits in individual~     patients. Consistent with these recommendations, the investigators will target patients with~     triple-negative breast cancer who do not have a pathologic complete response after~     neoadjuvant chemotherapy. These patients typically have no gross evidence of disease~     following standard of care therapy (neoadjuvant chemotherapy, surgery and radiation therapy)~     but are at extremely high-risk for disease recurrence. Targeting this patient population~     provides a window-of-opportunity to design and manufacture the personalized cancer vaccines,~     maximizes the potential benefit from the vaccine as the regulatory networks associated with~     metastatic disease are not present, and balances risk in this patient population with~     extremely high risk for disease recurrence but no other treatment options.~   "
87054|NCT02427568|"~     This small study is designed to provide information on whether MDMA-assisted psychotherapy is~     safe and helpful for people with anxiety related to a life-threatening cancer or neurological~     illness. The research is to see if psychotherapy combined with MDMA in a therapeutic setting~     can ease anxiety in the face of a life threatening illness. Once enrolled in the study,~     people will either receive two day-long psychotherapy sessions with MDMA or placebo, with~     five people getting placebo and 13 getting MDMA. Anxiety, depression, sleep quality,~     attitudes toward death, posttraumatic growth, mindfulness, self-compassion, and overall~     quality of life will be measured at the start of the study and after these two sessions.~     People close to the participant will also complete questionnaires about the participant~     during the study on their mood and behavior. Participants who received placebo can enroll in~     Stage 2, during which they will receive three psychotherapy sessions with MDMA, and~     participants who received MDMA will have a third MDMA-assisted experimental session. Anxiety~     and other symptoms will be measured again six and 12 months after each participant's final~     experimental session.~   "
87055|NCT02427555|"~     The main objective is to investigate gut microflora composition in relation to~     cardiometabolic risk markers, and to investigate the effects of 3 days intervention with a~     barley kernel based product on these variables.~   "
87056|NCT02427542|"~     This is a feasibility trial designed to test the feasibility and acceptability of a brief~     form (six sessions) of Cognitive Behavioural Therapy (CBT) for~     Depersonalisation/Derealisation (DP/DR) in those individuals who also have a diagnosis of a~     psychotic disorder. Participants will be randomised to receive either six sessions of CBT~     targeting DP/DR symptoms or to a treatment as usual control condition.~   "
87057|NCT02427529|"~     Subjects are female patients, randomized to HCG group or placebo group, during a prospective~     trial, in order to determine the significance, if any, of HCG on maintaining muscle mass~     during a very low calorie diet in order to demonstrate the potential significance of HCG~     administration on preserving lean body mass while losing weight.~   "
87058|NCT02427516|"~     To estimate annualized total cost rates (i.e. direct medical costs from hospitalizations,~     consultations, medications, and tests) of adequately controlling a patient (i.e. INR between~     2-3 and TTR≥ 60%) diagnosed with non-valvular atrial fibrillation (NVAF) or venous~     thromboembolism (VTE), and treated with vitamin K antagonists (VKA) in Spain.~   "
87059|NCT02427503|"~     Inflammation of the nasal and bronchial mucosa characterizing rhinitis and asthma are~     probably manifestations of the same disease. Multiple functional observations, pathogenic and~     clinical support that assertion. It is noteworthy that most asthma patients, who underwent a~     nasal endoscopic polypectomy, improve your asthma after surgery. This improvement would be~     related to the administration of oral steroids that these patients usually receive after~     surgery, or the disappearance of nasal discomfort caused by nasal polyps to improve~     ventilation. But this does not explain why this improvement, in some cases lasting for months~     after the operation, and without receiving oral steroids. It is speculated that severe nasal~     inflammation due to nasal polyps stimulate the bone marrow to produce more eosinophils, an~     increased supply of blood eosinophils, and consequently, a major bronchial eosinophilic~     inflammation, aggravating asthma. However, it is noteworthy that studies have evaluated the~     clinical impact in asthma after endoscopic nasal polypectomy, are scarce or performed on a~     small number of cases, the results are inconsistent and do not allow categorically whether or~     not such positive association. And more importantly, none of them included measurements of~     airway inflammation and hypothesized relationship between bronchial eosinophilic inflammation~     and nasal polyposis, aclarar.La remains finding that provides nasal endoscopic polypectomy~     objective improvement of severe asthma it could be a future therapeutic option to consider in~     patients with asthma and rhinosinusal polyposis.~   "
87060|NCT02427490|"~     In congruence with the National Cancer Institute's commitment to supporting families of~     individuals with cancer across the full disease trajectory, the investigators seek to examine~     the feasibility of a technologically-mediated problem-solving intervention designed to~     improve the quality of life and decrease the psychological distress of family caregivers of~     cancer patients receiving outpatient palliative care. Investigators involved in this mixed~     methods pilot study will collect and analyze both quantitative and qualitative data, which~     will subsequently inform a large-scale randomized clinical trial of the problem-solving~     intervention.~   "
87061|NCT02427477|"~     Approximately 120 subjects will be comparing two soft contact lenses for one week each.~   "
87062|NCT02427464|"~     The purpose of this study is to determine the safety and efficacy of bilateral intramuscular~     injections of VM202 versus placebo in the treatment of painful diabetic neuropathy.~      A total of 477 subjects will be randomized in a 2:1 ratio to one of two treatment groups:~      Treatment - VM202 - 318 subjects Control - Placebo (VM202 vehicle) - 159 subjects~      Randomization will be stratified by current use of gabapentin and/or pregabalin.~   "
87112|NCT02426814|"~     The purpose of this study is to assess the use of a mobile health intervention to improve~     adherence to asthma medication among adolescents. The intervention consists of an inhaler~     sensor strap to monitor asthma inhaler use and a mobile phone application to remind and~     incentivize patients to use their medication. This study will assess medication use~     throughout a 12 week study in patients who receive a mobile app with reminders, asthma~     control as measured by the ACT [asthma control test], and lung function as measured by~     spirometry.~   "
87063|NCT02427451|"~     This phase Ib/II trial studies the best dose and safety of Bcl-2 inhibitor GDC-0199 in~     combination with obinutuzumab and ibrutinib and to see how well they work in treating~     patients with chronic lymphocytic leukemia that has returned (relapsed), does not respond to~     treatment (refractory), or is previously untreated. Bcl-2 inhibitor GDC-0199 and ibrutinib~     may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~     Monoclonal antibodies, such as obinutuzumab, may block cancer growth in different ways by~     targeting certain cells. Giving Bcl-2 inhibitor GDC-0199 together with obinutuzumab and~     ibrutinib may be a better treatment for chronic lymphocytic leukemia.~   "
87064|NCT02427438|"~     The primary purpose of this study is to assess the effect size of the change in Oswestry~     Disability Questionnaire (ODQ) score over the 8 week follow-up period between the video based~     instruction or standard of care hand-out with pictures and written instructions for subjects~     meeting the clinical prediction rule for lumbar stabilization.~      The second purpose will be to determine if there is a subset of physical examination and~     self-reported variables that are associated with having a successful result (ODQ improvement~     by at least 6 points) and if the subset of variables are affected by whether or not the~     subject was in the intervention (video) or control (handout) group.~   "
87065|NCT02427425|"~     Introduction: Low back pain is one of the most common complaints in doctors' offices, and~     acute low back pain is characterized by episodes of pain with less than three weeks duration.~     The transcutaneous electrical nerve stimulation (TENS), based on the gate control theory of~     pain proposed by Melzack and Wall in 1965, has been used as an adjunctive therapy in the~     control of back pain, being a non-invasive, low cost, safe and easy to apply. No studies were~     found regarding the effectiveness of TENS in acute low back pain.~      Objective: To evaluate the effectiveness of TENS in pain management of patients with acute~     low back pain.~      Material and Methods: A randomized clinical trial, double-blinded and placebo-controlled.~     Patients were selected in the clinics of Federal de University of Sao Paulo (UNIFESP)~     according to the following criteria: acute low back pain, both genders, aged between 18 and~     65 years, pain between 4 and 8cm in pain numeric scale (PNS) and who agreed to participate in~     the study. After signing the informed consent patients were randomly allocated into one of~     the groups: TENS group (TG) or Placebo Group (PG). In TG was applied conventional TENS with~     frequency and intensity variation (FIV) effect, frequency of 100 hertz, a pulse width of 60μs~     and intensity adjusted according to the individual baseline for each patient without causing~     muscular contraction. The electrodes were arranged in a cross shape in the paravertebral~     region (levels T12-L1 and L5 - S1). In PG the same procedures were adopted, but did not occur~     electrical stimulus. Patients were informed that they could or could not feel electric~     shocks. Treatment consisted of 10 sessions (2x / week / 5 weeks), with each session lasting~     30 '. Assessments were made at the following times: T0 (baseline), T1 to T10 (the beginning~     and end of each session), T11 (after the last session), T30 (30 days after the last session)~     and T60 (60 days after the last session). Assessment tools: PNS for pain, short-form 36~     (SF-36), Roland-Morris, self-assessment of improvement (Likert scale) and drug consumption~     (daily).~   "
87066|NCT02427412|"~     A randomized, prospective, placebo-controlled study which aims to evaluate the effect of~     combined intraarticular and intravenous Tranexamic acid on total blood loss following~     unilateral knee replacement versus only intravenous tranexamic acid.~   "
87067|NCT02427399|"~     The purpose of this project is to determine whether outreach to HIV-negative patients who are~     overdue for a Pap smear at a New England urban community health center can increase cervical~     cancer screening rates. It additionally seeks to determine which form of outreach - via~     letter, email, phone, or a mixture of those modalities- is most effective among these~     patients.~   "
87068|NCT02427386|"~     Endometriosis is a chronic inflammatory disease that causes pelvic pain difficult to treat.~     In view of this, many patients seek assistance in complementary and alternative medicine,~     including homeopathic treatment. The absence of evidence in the literature raises controversy~     about the effectiveness of homeopathic treatment in endometriosis. The aim of this randomized~     trial is to evaluate the effectiveness of dynamized estrogen compared to placebo in the~     treatment of chronic pelvic pain of endometriosis.~   "
87069|NCT02427373|"~     A multiple-dose, double-blind, randomized, four-week, three-treatment, parallel study in~     which 66 healthy adult subjects will receive 6 capsules/d, administered as a dose of 1.3 g/d~     eicosapentaenoic acid (EPA)+docosahexaenoic acid (DHA) in fish oil ethyl ester (EE), or fish~     oil triglyceride (TG) or krill oil for a total of 4 weeks. The objective of the study is to~     compare the oral bioavailability of EPA+DHA in total plasma across the three formulations at~     the end of the 4 week study.~   "
87070|NCT02427360|"~     This is a retrospective non randomized cohort to evaluate efficacy of MAS3 on patients with~     uncomplicated P. falciparum malaria or mixed infection (P. falciparum + a non-falciparum~     species). The review of patients' records and blood samples will be performed for patients~     treated at the clinics of Shoklo Malaria Research Unit from the period of January 2003 to~     December 2013.~   "
87071|NCT02427347|"~     To evaluate the effectiveness of acupuncture therapy combined with healthy education for~     patients with abdominal obesity.~   "
87072|NCT02427334|"~     Two hundreds and ten women with premenstrual syndrome will be randomly divided into 3 equal~     groups using computer generated random numbers. Group 1 will receive oral dienogest (visanne®~     Bayer, Germany) 2mg for 14 days starting from the 15th day of menstruation, Group 2 will~     receive fluoxetine (Prozac® Lilly, UK) 20mg and group 3 will receive an oral placebo foe 14~     days starting from the 15th day of menstruation.~   "
87073|NCT02427321|"~     This study will collect video recordings of routine flexible cystoscopy examinations, medical~     history and diagnosis information, from up to 100 participants who have a history of bladder~     cancer, or symptoms suggestive of bladder cancer, in order to develop a new computer system~     for recording and reviewing images of the bladder, and to assess the utility of this system.~   "
87074|NCT02427308|"~     The purpose of this observational study is to fulfill FDA Post Marketing Requirement (PMR)~     2127-1 for miltefosine (NDA204684): implement a pregnancy registry for the time period Mar~     2015-Mar 2024.~      This study is a prospective observational study in which female patients undergoing Impavido~     who become pregnant during treatment or within 5 months after completing treatment can~     volunteer to provide information about their pregnancy and the outcome of the pregnancy.~   "
87075|NCT02427295|"~     Long-term (up to 3 years) clinical and hormonal outcomes in acromegalic patients with treated~     surgery with or without long acting somatostatin analogues.~   "
87076|NCT02427282|"~     This study aimed to compare the effectiveness and efficiency of miniscrew-supported and~     standard frog molar distalizing appliances.~   "
87137|NCT02426489|"~     The purpose of the study is to assess whether the addition of positron emission mammography~     will add diagnostic value to magnetic resonance imaging of the breast, in patients with~     lesions of the breast that are suspicious enough to warrant biopsy, or which have been~     confirmed as containing cancer cells.~   "
87077|NCT02427269|"~     Aim 1: To develop a prospective tissue and blood biorepository from patients with a history~     of Barrett's Esophagus (BE) or esophageal cancer (ECA) presenting to UNC hospitals for~     routine care upper endoscopy for their condition.~      Aim 2: To collect clinical data from patients with a history of Barrett's Esophagus (BE) or~     esophageal cancer (ECA) that includes demographic data, endoscopic procedure data, and~     pathology data.~      Aim 3: To integrate Aim 1 and 2 in a manner that will provide an efficient bi-directional~     flow of clinical information and specimens between laboratory and clinical scientists in~     order to foster innovative translational research.~      Aim 4: To create a biorepository for future IRB approved studies that have a tissue and/or~     blood specimen component.~   "
87078|NCT02427256|"~     The primary objective of this clinical study is to collect additional clinical data to~     support an FDA 510(k) submission for the Topcon Specular Microscope SP-1P. The secondary~     objective is to evaluate any adverse events found during the clinical study.~   "
87079|NCT02427243|"~     To assess the relative bioavailability and tolerability of two different formulations of~     crenezumab in approximately 60 healthy volunteers.~   "
87080|NCT02427230|"~     The purpose of this study is to determine whether pelvic floor muscle training (PFMT) and~     intravaginal neuromuscular electrical stimulation (NMES) are effective in reducing urinary~     incontinence and improving quality of life in women with spinal cord injury (SCI).~   "
87081|NCT02427217|"~     This is a multicenter, non interventional, retrospective cohort study with a prospective,~     observational follow-up component to investigate the safety and efficacy of FCH use in~     subjects with congenital fibrinogen deficiency. Data will be collected on the safety and~     efficacy of FCH as used for the treatment of acute bleeding episodes, routine prophylaxis and~     perioperative bleeding in these subjects. All subjects have received FCH and may continue to~     receive FCH at the discretion of the treating physician / Primary Investigator according to~     the standard of care at the participating study site.~   "
87082|NCT02427204|"~     The main questions being addressed are (1) how patient reported outcomes change during~     treatment for HCV, (2) how treatment impacts liver function and liver status, and (3) how~     much treatment costs from the payer's perspective and the patient's perspective. The~     hypothesis being tested is that treatment has a negative effect on the quality of life during~     treatment. The negative effect is expected to be temporary. Successful treatment, which is~     equated with a virological cure of the infection, is expected to result in an improvement in~     quality of life compared to baseline and to improvement in markers of liver function and~     liver status. Costs of treatment are expected to be $80,000-$200,000 per virological cure.~   "
87083|NCT02427191|"~     Prospective, single-blinded, randomized controlled trial of the micronized dHACM injection as~     compared to the saline placebo injection in the treatment of plantar fasciitis~   "
87084|NCT02427178|"~     The purpose of this study is to find out if a stem cell transplant is safe for patients with~     a very rare disease. The stem cell transplant is called AHSCT (for allogeneic hematopoetic~     stem cell transplantation). The rare disease is called MNGIE (for Mitochondrial~     NeuroGastroIntestinal Encephalomyopathy). Patients with MNGIE will be transplanted with stem~     cells from an individual who is human leukocyte antigen (HLA) 10/10 matched. The purpose of~     the transplant is the production of thymidine phosphorylase.~   "
87085|NCT02427165|"~     The number of people with of asthma and allergy is still increasing and a large number of~     patients still do not have their asthma well controlled. There is therefore a need for new~     asthma treatments that work well and have less side effects. The study compares a new~     experimental drug RPL554 with a marketed asthma drug (salbutamol) and placebo.~   "
87086|NCT02427152|"~     Obesity is considered to be caused by an imbalance between energy expenditure and energy~     intake. A major determinant of our daily energy intake is the size of the meals that we~     consume. It has been suggested that decisions about portion sizes are often made in advance,~     before a meal begins. This pre-meal planning is considered to especially depend on the~     estimated 'expected satiety' and 'expected satiation' of different foods. Further, also~     factors like weight concern and palatability of the food might have their influence on meal~     size selection. In general, it is not clear how these factors are integrated during pre-meal~     planning and which brain networks are involved in these decisions/this process. Thus, the~     investigators plan to study pre-meal planning in healthy, normal-weight and overweight/obese~     individuals with functional magnetic resonance imaging under different cognitive instructions~     including pleasure, expected satiety and self-control in terms of health consequences. The~     investigators will explore the neural networks involved in pre-meal planning and expect them~     to be modulated by the before mentioned factors. Further, the investigators plan to explore~     gender differences and expect that female subjects will select smaller portion sizes~     especially in the self-control condition as they are often more concerned about their~     weight/health. Finally, the investigators will explore differences between lean and~     overweight subjects to elucidate factors that might lead to increased meal sizes in~     overweight subjects.~   "
87087|NCT02427139|"~     The specific aim of the study is to do comparison between ANSiStim and Placebo for pain~     relief in labor. During the treatment, pain relief will be assesed with ANSiStim in active~     labor through continues checking of VAS SCORE. ANSiStim has been tried in post operative~     patients with good pain relief .~   "
87088|NCT02427126|"~     Multicentre (national, Germany), randomized (2x2 factorial), open, parallel group, active~     controlled, efficacy study (phase III)~   "
87089|NCT02427113|"~     The purpose of the study will be to examine the effectiveness of an innovative use of music~     on TMD. Music and rhythmic vibrations can alter the basic processes related to sensation of~     pain in the brain. As well, music can block the neurological pathways that transmit pain~     sensations and thereby reduce pain. Music and vibrations are relaxing, reduce stress, and~     thereby reduce sensitivity to pain.~   "
87113|NCT02426801|"~     The purpose of this study is to assess the feasibility of using a mobile health intervention~     to improve adherence to asthma medication among adolescents in an urban clinic setting. The~     intervention consists of an inhaler sensor strap to monitor asthma inhaler use and a mobile~     phone application to remind and incentivize patients to use their medication. This study will~     assess the feasibility and acceptability of this intervention to patients.~   "
87145|NCT02426385|"~     The study is an observational non-randomised controlled study comparing the visual acuity~     after implantation of the POD 26% FINEVISION TORIC with respect to the POD 26% TORIC~   "
87090|NCT02427100|"~     The proposed study will utilize a randomized controlled trial design to pilot-test a 4-week~     shelter-based diet and physical activity intervention in a sample of homeless adults residing~     in the transitional shelter at The Bridge Homeless Assistance Center in Dallas, TX (N = 50).~     Participants will be randomly assigned to a diet/physical activity intervention group (n =~     25) or a paid assessment-only control group (n = 25). Three intervention strategies will be~     employed: 1) computer-tailored newsletters adapted from a program supported for use in other~     populations, 2) the distribution of fruit and vegetable snacks directly to individuals, and~     3) the provision of pedometers and walking goals. Thus, the primary aim of the proposed study~     is to 1) evaluate the feasibility and effectiveness (relative to an assessment-only control~     group) of a shelter-based intervention designed to improve dietary intake and increase~     physical activity among homeless individuals. The main study outcomes will be average daily~     fruit and vegetable consumption and objective pedometer/ accelerometer assessment of physical~     activity (assessed weekly) over the 4-week study period, and at a follow-up assessment 4~     weeks after the conclusion of the intervention. Secondary aims will focus on: 2) identifying~     intervention-related differences (relative to the control group) in indicators of physical~     health including blood pressure, weight, body mass index (BMI), waist circumference, and~     other dietary variables (i.e., caloric intake, meals consumed outside of the shelter, daily~     fat and fiber intake) and 3) identifying psychosocial variables associated with dietary~     quality and physical activity.~   "
87091|NCT02427087|"~     Were included 40 patients with NAFLD followed at the Ambulatory of Non-alcoholic Fatty Liver~     Disease , Discipline of Clinical Gastroenterology, Clinic Hospital of the Medical School of~     the University of Sao Paulo (HC-FMUSP). Were included adults women of any race, aged 35 to 75~     years, diagnosed with NAFLD and were followed for a period of six months. All patients~     underwent anthropometric and body composition, as well as analysis of clinical, laboratory~     before and after 6 months of exercise training protocol established.~      The hypothesis of our research is that aerobic activity had a favorable impact on NAFLD. It~     is expected that the intervention of physical activity causes a decrease or no weight,~     decreased levels of aminotransferases, decreased insulin resistance assessed by homeostasis~     model assessment (HOMA) index and consequently decrease or reversal of hepatic steatosis.~   "
87092|NCT02427074|"~     Two percutaneous procedures used in the treatment of idiopathic trigeminal neuralgia are~     analysed. The effects on pain relief, alterations in cutaneous sensibility and olfactory and~     salivatory functions are analysed as well.~   "
87093|NCT02427061|"~     Sexual violence (SV) and adolescent relationship abuse (ARA) are prevalent among adolescents~     and associated with poor health. Global health organizations highlight engaging men and boys~     in preventing violence against women as a potentially impactful public health strategy. This~     study aims to test, via a two arm cluster randomized controlled trial, a gender~     transformative SV/ARA perpetration prevention program among African American adolescent~     males ages 13-19 (target is high school age) implemented in a community-based setting.~     Gender transformative refers to a theory- and evidence-based approach to alter gender norms~     that foster SV/ARA while promoting bystander intervention (i.e., giving boys skills to~     interrupt abusive behaviors they witness among peers) to reduce SV/ARA perpetration. As the~     acceptance of SV and involvement in unhealthy sexual behaviors are associated with SV/ARA~     perpetration, this program integrates analysis of social norms that condone violence against~     women, sexual health promotion, and skills in bystander intervention -- an approach that has~     been implemented in multiple non-U.S. settings among young adult males with reductions in~     violence, development of more equitable gender attitudes, and less risky sexual behaviors.~     This will be the first test of such a gender transformative program among adolescent males in~     the U.S. Via a 2-arm cluster-randomized trial in youth-serving agencies (16 clusters, N=840~     adolescent males ages 14-19), this study will assess the effectiveness of Manhood 2.0~     (proposed name for this gender transformative program) compared to a job skills curriculum.~     Three months after the end of the program (Time 2), compared to controls, youth will~     demonstrate increased positive bystander intervention behaviors (secondary outcome).~     Intermediate outcomes are: condom use self-efficacy; contraception use attitudes; recognition~     of abusive behaviors; gender-equitable attitudes; and intentions to intervene with peers.~     Nine months after intervention completion (Time 3), youth will report less perpetration of SV~     and ARA toward females (Primary Outcome) compared to controls. This study will provide~     urgently needed information about the effectiveness of a gender transformative program that~     combines healthy sexuality skills, gender norms change, and bystander skills to interrupt~     peers' disrespectful and harmful behaviors to reduce SV/ARA perpetration among adolescent~     males.~   "
87094|NCT02427048|"~     This study will develop and test an intervention given to emergency medicine providers to~     improve adherence to clinical practice guidelines (CPGs) for pneumonia and sepsis.~   "
87095|NCT02427035|"~     This is a phase 1 multicenter, randomized, double-blind, placebo-controlled, ascending dose~     study to investigate the pharmacokinetics (PK), safety, and tolerability of CSL112 in adult~     subjects with moderate renal impairment and in healthy adult subjects with normal renal~     function.~   "
87096|NCT02427022|"~     Clinical social workers and other staff providing direct care to individuals experiencing~     homelessness face multiple challenges in obtaining training and implementing evidence-based~     practices in diverse community settings. Critical Time Intervention (CTI) is an increasingly~     popular evidence based practice with these agencies.~      With funding from a Phase II Small Business Innovation Research grant from the National~     Institute of Mental Health, the Center for Social Innovation developed an online multi-media~     training on CTI which incorporates a Community of Practice approach to encourage peer-based~     learning.~      The primary aim of this longitudinal, randomized-control study is to compare and contrast~     this online training modality with a face-to-face training on implementation of and fidelity~     to the CTI model over time. Nearly two-hundred direct service providers from 20~     homeless-service agencies were randomly assigned to complete either an online or face-to-face~     training in CTI. Pre-post training and knowledge-retention surveys, interviews with trainers,~     agency administrators, and providers were conducted to track satisfaction with the training~     and experiences in implementing CTI. CTI-specific chart forms are used to assess fidelity to~     the CTI model, and administrative data from the agencies capture client-level outcomes.~   "
87097|NCT02427009|"~     The main objective of this study is to assess the rate of recurrence of headache following a~     first blood patch where patients will be positioned in the prone position for an hour after~     each blood patch needed during this study.~   "
87098|NCT02426996|"~     The main objective of this study is to evaluate, after surgery for chronic anterior shoulder~     instability using a Latarjet technique with positioning of the bone block via an SEM~     positioning tool, the value of the contribution of a shoulder scan at 3 months post surgery~     in the decision to return to activity early as conditioned by the quality of the bone block~     consolidation.~   "
87146|NCT02426372|"~     The purpose of this open-label, dose-ranging, exploratory study is to evaluate the safety,~     tolerability, compliance, mechanism of action and efficacy of QBECO site specific~     immunomodulation for the induction of clinical response and remission in subjects with~     moderate to severe ulcerative colitis~   "
87099|NCT02426983|"~     Transcranial direct current stimulation (tDCS) is a non-invasive form of brain stimulation~     which uses a very weak constant current to temporarily excite the brain area of interest via~     small electrodes placed on the scalp. Currently, tDCS is being used as a tool to investigate~     mental processes (cognition) and motor function (movement) in healthy controls and to treat~     neurological (i.e. stroke) and psychiatric (i.e. depression and dementia) patients. tDCS has~     been found to improve motor processes and cognitive performance, including attention and~     memory functions. This study will attempt to examine the effects of tDCS on a specific aspect~     of short term memory to sounds measured from electrical activity (EEG) from the top of the~     scalp. This study will also assess the effect of a drug, dextromethorphan (DMO), commonly~     found in cough syrup, which is thought to regulate tDCS treatment through brain receptors.~     The study involves four laboratory test sessions. EEG assessments will be done in two~     sessions involving 'anodal' tDCS stimulation (to temporarily excite cortical activity~     locally), one session with DMO treatment and one with placebo treatment, and two sessions~     involving 'sham' tDCS stimulation (device is turned off), with the same DMO and placebo~     treatments. These findings will contribute to our understanding of the brain chemistry~     involved in tDCS treatment and its effects on cognitive abilities.~   "
87100|NCT02426970|"~     The main objective of this study is to evaluate whether acceptance (measured by the AAQ-II~     questionnaire) is prognostic of algo-functional changes measured by the Oswestry Disability~     Index, ODI) at 6 months.~   "
87101|NCT02426957|"~     The study will use a two group randomized controlled trial to compare a brief motivational~     interviewing (MI) intervention to TAU with 50 adolescents psychiatrically hospitalized for a~     suicide plan or attempt who have co-occurring alcohol use. Data will be collected via~     in-person interviews and self-administered questionnaires at baseline and 3 month follow-up~     assessments to explore outcome changes in negative alcohol expectancies, confidence in~     ability to handle situations where alcohol is present, likelihood of receiving alcohol~     treatment, frequency of alcohol use, and suicidal ideation, suicide planning, and suicide~     attempts for adolescents receiving the intervention relative to TAU.~   "
87102|NCT02426944|"~     Atrial fibrillation (AF) is the most common cardiac arrhythmia with a prevalence of 1-2%.~     Without antithrombotic treatment, the annual risk of a cardioembolic event is 5-6%. The~     source of a cardioembolic event is a thrombus, which usually forms in the left atrial~     appendage (LAA). The prevention of cardioembolic events involves treatment with anticoagulant~     drugs, which were limited to, until recently, vitamin K antagonists (e.g. warfarin).~     Anticoagulant treatment with warfarin can lead to adverse bleeding events, some of which can~     be life threatening. Recently, two new options for thrombus prevention have been developed.~     The first is the novel anticoagulants (NOAC), which were associated with slightly better~     safety profiles due to a lower frequency of intracranial bleeding in large randomized trials~     . The second option involves interventional occlusion of the LAA. The aim of this project is~     to compare the LAA occlusion intervention to NOAC pharmacological treatment in a randomized~     multicenter study of AF patients at high risk of a cardioembolic event.~   "
87103|NCT02426931|"~     This study evaluates the safety and efficacy of the novel tip-flexible semi-rigid~     ureterorenoscope for the treatment of renal calculi using a prospective, randomized~     multicentre trial design. Half of participants will receive retrograde intrarenal surgery~     using the tip-flexible semi-rigid ureterorenoscope, while the other half participants will~     receive retrograde intrarenal surgery using the classic flexible ureteroscope.~   "
87104|NCT02426918|"~     The primary objective of this study is to evaluate the efficacy of 2 different doses of~     intravenous and oral Debio 1450 compared with intravenous vancomycin and oral linezolid in~     the treatment of patients with staphylococcal ABSSSI.~   "
87105|NCT02426905|"~     A study to review Wilson disease patients who have previously been prescribed d-~     Penicillamine but were changed to trientine as treatment for their disease, and to follow~     them for a further 12 months.~   "
87106|NCT02426892|"~     The goal of this clinical research study is to learn if nivolumab combined with ISA101 can~     help to control cancer that has spread. The safety of the study drugs will also be studied.~      This is an investigational study. ISA101 is not FDA approved or commercially available. It is~     currently being used for research purposes only. Nivolumab is FDA approved to treat certain~     types of melanoma in patients who no longer respond to other drugs. Combining ISA101 with~     nivolumab is investigational. The study doctor can explain how the study drugs are designed~     to work.~      Up to 28 participants will be enrolled in this study. All will take part at MD Anderson.~   "
87107|NCT02426879|"~     There is no world-wide consensus on the oncological benefit versus increased morbidity~     associated with three field lymphadenectomy in patients with esophageal cancer and cervical~     lymph node metastases. In Asian countries, esophagectomy is commonly combined with a three~     field lymphadenectomy, including resection of cervical, thoracic and abdominal lymph nodes.~     However, in Western countries patients with cervical lymph node metastases are generally~     precluded from curative treatment.~   "
87108|NCT02426866|"~     The purpose of this study is to determine whether there is an increased risk of~     cardiovascular events (CV) with regimens containing efavirenz (EFV) versus other regimens in~     patients with HIV.~   "
87109|NCT02426853|"~     The goal of this research study is to learn how students react to seeing a photograph of any~     skin damage they may have on their face. This skin damage may be caused by sun exposure or~     use of tanning beds. Researchers also want to learn about students' sun protection, tanning~     behaviors, and attitudes towards sun exposure, sun protection, tanning behaviors and skin~     cancer.~      Researchers will use the results of this study to design programs for students about sun~     protection and tanning avoidance.~   "
87110|NCT02426840|"~     Since there is no cure for HIV, therefore antiretroviral therapy must be taken life-long.~     Some of the HIV medications can negatively impact the health of the bone and is even more~     exacerbated in perinatally HIV-injected children and adolescents because this is the period~     when the bone peaks. Bone loss during this period can be devastating and increase the risk~     for developing weak bones later in life. Supplementation of calcium and vitamin D have not~     been well studied in HIV-infected children and adolescents in developing countries. Therefore~     it is not clear whether higher doses of these supplementations can thwart the damages or not.~   "
87114|NCT02426788|"~     Brief Summary: Persistent Physical Symptoms (PPS; also known as medically unexplained~     symptoms - MUS) is a term used to describe a range of physical health difficulties that~     people can experience and for which the exact cause is unclear. Between 20 and 40% of~     patients in primary care, and about 50% in secondary care experience PPS. Not only are PPS~     common, but the overlap across different patient groups may indicate that these phenomena are~     transdiagnostic. PPS are associated with profound disability and high health care costs, and~     if left untreated the prognosis of these patients is poor. There is an accumulating body of~     evidence demonstrating that cognitive behavioural interventions can reduce levels of symptoms~     and improve functioning in patients with PPS. A pragmatic RCT was designed to evaluate the~     clinical and cost-effectiveness of cognitive behavioural therapy (CBT) + Standard Medical~     Care (SMC) versus Standard Medical Care alone, in the treatment of patients with PPS. The~     trial will focus on patients with a variety of symptoms (e.g., non-cardiac chest pain,~     fibromyalgia), across secondary care clinics (e.g., neurology, cardiology, and rheumatology).~   "
87115|NCT02426775|"~     A Phase IIIb (Three b), Randomized Multicentre Comparative Trial to Evaluate the Long Term~     Effectiveness & Safety of the use of Carglumic Acid (Carbaglu®) in Patients with Propionic~     Acidemia (PA) or Methylmalonic Acidemia (MMA). Carbaglu® clinical experience in Organic~     Acidemia (OA) is limited to a non-comparative retrospective collection of data from patients~     who had received Carbaglu® for 1 to 15 days.~      There is no current evidence supporting the use of carglumic acid for the chronic management~     of patients with OA. The investigators are proposing a randomized multicentre prospective~     clinical trial to evaluate long-term effects of the use of Carbaglu® (50mg/kg/day) combined~     with standard chronic therapy in patients with PA and MMA compared to standard chronic~     therapy alone.~   "
87116|NCT02426762|"~     The purpose of this study is to evaluate the short-term effect of sealant-assisted skin~     closure in prevention of surgical site infection after laparoscopic surgery.~   "
87117|NCT02426749|"~     This proposal aims to investigate the effect of a promising treatment for persistent post~     Traumatic Brain Injury (TBI) symptoms, and to monitor TBI patient's recovery by an objective~     technique along with standard clinical assessments. The treatment tool is the application of~     repetitive Transcranial Magnetic Stimulation (rTMS) to the dorsolateral prefrontal cortex~     (DLPFC) of the brain. The treatment efficacy and monitoring TBI patients' recovery will be~     objectively assessed using Electrovestibulography (EVestGTM); this will be in parallel with~     clinical and standard assessments.~   "
87118|NCT02426736|"~     In this factorial design study, 280 participants having outpatient, arthroscopic shoulder~     surgery will be randomized into 4 equal sized groups. All participants will receive a~     standardized interscalene brachial plexus block and 4mg or 8mg of dexamethasone given by the~     intravenous or perineural (by the nerve with the nerve block) route just prior to their~     surgery. The purpose of this study is to determine which dose and route of dexamethasone~     provides the longest duration of pain control and the fewest side effects after surgery. The~     investigators hypothesize that giving dexamethasone by the perineural route, and by higher~     doses, will result in the longer durations of pain control, without increased side effects.~   "
87119|NCT02426723|"~     This is a Phase 1a/1b, multicenter, open-label, two-part study in subjects with relapsed or~     refractory MM:~        -  Phase 1a: single agent CWP232291. Dose-finding followed by cohort expansion at the~          maximum tolerated dose (MTD) or optimal dose as determined by the Safety Review~          Committee (SRC).~        -  Phase 1b: CWP232291 in combination with lenalidomide and dexamethasone. Dose-finding~          followed by cohort expansion at the combination therapy MTD or optimal dose as~          determined by the SRC.~   "
87120|NCT02426710|"~     Background: Radiofrequency ablation of typical atrial flutter present the most effective~     treament option in treatment of atrial flutter. Despite its high efficacy, due tovariant~     anatomy of cavotricuspid isthmus (CTI), i.e. location of right coronary artery, pouches, the~     achievment of complete bidirectional block across the CTI is sometimes chalenging.~     Intracardiac echocardiography (ICE) is a very usefull tool for on-line vizualization of the~     anatomy of the atria and also for the location of catheter position on CTI during ablation.~     If the routine use of ICE is associated with easier atrial fluter ablation is not clear.~      Methods: One hundred consecutive patients indicated for typical atrial flutter ablation will~     be enrolled into the study. The patients will be randomized into group (A) ablation with use~     of ICE and (B) ablation without ICE. The ablation will be done in both groups by two~     diagnostic catheters (10-pole positioned in coronary sinus and 20-pole halo catheter~     positioned in the right atrium) and radiofrequency ablation catheter. The end-point of the~     ablation is the achievment of the bicidrectional block across the CTI. The end-points of the~     study are 1) the total length of the procedure, 2) the fluoroscopy time and 3) the ablation~     time. The safety end-point is clinically significant bleeding from the groin due to~     additional puncture for ICE catheter.~      Discussion: We hypothesize the use of ICE wil shorten the radiofrequency energy delivery,~     fluoroscopy time and the length of the procedure without increasing the bleeding.~   "
87121|NCT02426697|"~     The clinical trial is a stage 3 study to determine the role of fentanyl transmucosal in the~     prevention of pain induced by mobilization in patients receiving a bone metastasis radiation~     for bone metastasis irradiations~   "
87122|NCT02426684|"~     IdeS® is an IgG-degrading enzyme of S.pyogenes that cleaves all four human subclasses of IgG~     with strict specificity. Alloantibodies are a major deterrent to access to and success of~     life-saving organ transplants. We hypothesize that the use of IdeS® pre-transplant in HS~     patients will represent a more robust and complete technique to eliminate DSA from the sera~     of HS patients. A single dose administration of IdeS® in the pre-operative period to HS~     patients with positive DSAs and flow cytometry crossmatches will durably eliminate~     circulating DSAs, allow transplantation to occur without ABMR and, in conjunction with~     standard desensitization therapy, result in a durable suppression of DSA levels thus~     eliminating the risk for ABMR.~   "
87135|NCT02426515|"~     This study is looking to see whether cooling the face using a special cooling device~     (Hilotherm®) before and during the removal of wisdom teeth will reduce the pain and~     discomfort patients feel after the procedure. The surgical removal of lower third molars~     (wisdom teeth) is arguably the most commonly performed surgical procedure worldwide. If this~     study shows that application of cold before and throughout the procedure is a simple way to~     reduce post-operative symptoms, it could benefit thousands of patients every year.~   "
87123|NCT02426671|"~     The investigators propose that a novel experimental device 'MuteButton' can affect the~     awareness of tinnitus. Sound that arrives at the ears naturally will be presented in the form~     of touch patterns on the tongue. By learning to associate the sounds in the ears with the~     sound patterns on the tongue, the investigators aim to demonstrate that the brain will learn~     to discriminate the real sounds from legitimate external sounds from the imaginary tinnitus~     sounds that are created inside the brain. Tinnitus is an audiological condition most commonly~     described as 'ringing in the ears' that affects an estimated 40 million people globally~     (American Tinnitus Association; Royal National Institute for Deaf). More accurately, tinnitus~     is the perception of illusory sound that has no legitimate external source and normally~     arises from a small number of underlying neuropathologies. There are broadly two categories~     of tinnitus Somatic Tinnitus and Hearing Loss Related Tinnitus.~      MuteButton is indicated for the treatment of permanent intractable subjective tinnitus. The~     study is intended to show the efficacy of MuteButton treatment in alleviating tinnitus. The~     objective of the study will be to determine the impact of acoustic and tactile multi-modal~     neuromodulation on symptoms of permanent intractable tinnitus as measured by objective and~     subjective measures including Minimum Masking Level (MML), Tinnitus Loudness Masking~     (Tinnitus Loudness Masking), Tinnitus Handicap Inventory (THI) and Visual Analogue Scale~     (VAS).~   "
87124|NCT02426658|"~     This pilot phase II trial studies how well pemetrexed disodium works in treating patients~     with stage IV non-small cell lung cancer and an Eastern Cooperative Oncology Group (ECOG)~     performance status of 3. Performance status means how well patients are able to perform daily~     activities and care for themselves. Patients with a performance status of 3 have a limited~     ability to move around. Currently, only patients who are able to perform most of their daily~     activities may receive chemotherapy, due to the side effects it may cause. Pemetrexed~     disodium causes fewer side effects than many chemotherapy drugs and may help treat patients~     with stage IV non-small cell lung cancer and a lower performance status.~   "
87125|NCT02426645|"~     The aim of this study is to investigate associations between early structural cellular injury~     and microvascular alteration with progression of septic organ dysfunction according to total~     SOFA-Score (an ICU-scoring system - the Sequential Organ Failure Assessment Score). Patients~     will be monitored for renal (TIMP-2, IGFBP7), and intestinal biomarkers (plasma i-FABP) in~     conjunction with kidney and muscle vascular bed microvascular perfusion analysis assessed by~     contrast-enhanced ultrasonography (CEUS). In parallel, a comprehensive analysis of patients'~     immunological status will be conducted using an established, on-site immune monitoring panel.~      The ultimate goal of this study is an early identification of septic patients developing~     multiorgan dysfunction which may facilitate a timely novel intervention in the future to~     improve outcome.~   "
87126|NCT02426632|"~     The primary objective is to evaluate in a double-blinded (neither physician nor participant~     knows the treatment that the participant receives), fashion the taste of different~     JNJ-53718678 oral liquid formulations as compared to the reference formulation (JNJ-53718678,~     10 milligram/milliliter oral solution without sweetener/flavor).~   "
87127|NCT02426619|"~     This randomized clinical trial aims to compare the effectiveness of three topical fluoride~     application protocols, namely three applications of a 30% SDF solution at yearly or weekly~     interval and three applications of a 5% NaF varnish at weekly interval, in arresting dental~     caries in the primary teeth of preschool children over 30 months.~   "
87128|NCT02426606|"~     The purpose of this study is to assess the effects of consuming various lentil varieties in~     mixed-meals (containing either white rice or white potato) on post-prandial blood glucose and~     insulin as compared to white rice or white potato alone.~   "
87129|NCT02426593|"~     This study will be conducted to collect anatomical data in an ambulatory healthy population~     to aid in the development of a novel non-invasive technology to assess changes in lung~     hydration status. It will also help in developing reference ranges of lung hydration status~     in healthy subjects and their associated changes with time.~   "
87130|NCT02426580|"~     This study is a prospective randomized controlled pilot trial. The investigators will use~     wechat intervening dietary protein intake in patients treated with peritoneal dialysis.~   "
87131|NCT02426567|"~     Current evidence suggests that the gut microbiota and dietary influences are as important as~     genetics in the aetiology of Crohn's disease (CD). We have recently shown that disease~     improvement, following treatment with Exclusive Enteral Nutrition (EEN), coincided with~     changes in the gut microbiota.~      The main purposes of this study are: a) to explore whether the gut microbiota changes we~     observed in this previous study in children with CD during EEN are disease specific or not,~     and b) to develop a novel food-based diet (Crohn's Disease TReatment-with-EATing/CD-TREAT~     diet) which will induce changes to the metabolic activity and bacterial composition of the~     gut microbiota of healthy people, similar to those seen on EEN, the first-line treatment for~     active paediatric CD.~      This study will produce high quality scientific evidence to move the CD-TREAT diet towards a~     preliminary clinical trial in patients with CD which is currently inappropriate and unethical~     to carry out in people with active CD undertaking contemporary medical treatment.~   "
87132|NCT02426554|"~     The feasibility of combining a motor and cognitive exercise program with dietary~     supplementation (DDU: Vitamin D, DHA and Uridine or Placebo) is tested in a smaller group of~     prepubescent children.~   "
87133|NCT02426541|"~     This is an 8-week, single centre, randomized, parallel-group, double-blind,~     placebo-controlled Phase IV study to evaluate the effect of dapagliflozin on tissue specific~     insulin sensitivity in patients with Type 2 diabetes mellitus~   "
87134|NCT02426528|"~     This cluster randomized trial will test the affect of individual participation in culturally-~     and socially-related activities on health and well-being, in comparison also with the classic~     individual determinant, in relation to urban renovation schemes. Investigators will using a~     questionnaire based on several areas such as individual psychological well-being (PGWBI),~     individual happiness positioning (Keyes Scale) and health status perception (SF-12 Health~     Survey). Secondary outcomes will be related to social capital density (relationships and~     trust), culture (participation) and religion. The survey will be undertaken in a mid-size~     Italian metropolitan area, namely the Metropolitan City of Bologna.~   "
88717|NCT02405858|"~     The purpose of this study is to evaluate the percentage of participants achieving~     prostate-specific antigen (PSA) response by 12 weeks of therapy from baseline according to~     Prostate Cancer Clinical Trials Working Group (PCWG2) criteria.~   "
87138|NCT02426476|"~     Pain initiates a stress response that increases sympathetic output and leads to autonomic~     imbalance. Heart rate variability (HRV) is a easy to perform, valid measure of autonomic~     function. HRV biofeedback (HRV-B) is a novel biobehavioral procedure in which patients learn~     to restore autonomic balance by developing 'HRV Coherence'. Patients in HRV Coherence have~     improved mood and cognition. The investigators' pilot study showed that HRV-B alleviated~     chronic pain and stress among Veteran Pain Clinic patients. HRV-B thus has a pivotal role in~     managing pain. The proposed project is a randomized, sham-controlled, biobehavioral~     intervention with HRV-B to test the hypotheses that HRV-B increases HRV coherence and reduces~     pain, stress, fatigue, insomnia and depression and improves sleep, activity, and cognition in~     Veterans with chronic neuromuscular pain. The investigators hypothesize that HRV-B will (1)~     reduce self-reported pain and stress ratings, (2) improve objective measures of actigraphic~     sleep parameters (sleep latency, duration, efficiency, fragmentation), rest/activity rhythms~     (dichotomy index, interdaily stability) and cognitive function (reaction time, attention);~     and (3) alleviate self-reported fatigue and depression symptoms. Patients from two groups~     will be randomized to the investigators' previously established HRV-B or sham protocol (n=40~     each), and will complete a baseline assessment, 6 weekly training sessions, a post-training~     assessment, and 4-week and 8-week follow-up evaluations post-training. Portable, hand-held,~     data-logging devices will be used to practice attaining HRV coherence at home by the active~     HRV-B training group, while those in the sham training group will get a 'stress squeeze~     ball'. Standard methods will quantify HRV coherence and other HRV measures, and validated~     instruments will be used to assess pain, stress, fatigue, insomnia, depression, and cognitive~     function. Wrist actigraphy will be used to objectively characterize insomnia via continuous~     recordings collected 24-hrs/day over three 1-week periods (pre-training, post-training, and~     at the 4 week follow-up assessments. Tests measuring attention and reaction time will assess~     changes in cognitive performance. Data analyses will apply linear models for repeated~     measures to evaluate the effect of HRV-B on study outcomes, and on treatment persistence,~     after adjusting for confounding factors. This study will be the first to examine HRV-B for~     pain management among Veteran chronic pain patients.~   "
87139|NCT02426463|"~     Children differ from adults with respect to growth and development but also immaturity of~     various pharmacological mechanisms. Dosing schemes in children are usually derived in an~     empirical manner from clinical trials in adult patient groups. All this poses neonates to an~     increased risk for therapeutic failure and adverse drug reactions.~      Medicinal products studied during this project are among the ones with the highest needs for~     research in the pediatric intensive care. This project focuses on the necessity to integrate~     subject's individual characteristics to assist clinical decision-making in drug therapy. The~     investigators explore the mechanisms defining the dose response in pediatric populations. The~     results obtained with these studies will help to find safer drug dosing regimens in this~     delicate patient population.~   "
87140|NCT02426450|"~     Hepatocellular carcinoma (HCC) is the fifth most common cancer in the world. Partial~     hepatectomy and liver transplantation are considered to be standard curative therapies for~     HCC. When surgery is not possible, percutaneous ablation is usually considered to be~     alternative treatments for HCC. Recurrence is the most frequent serious adverse event~     observed during the follow-up of HCC patients treated for cure. Repeat hepatectomy is an~     effective treatment for HCC recurrence, with a 5-year survival rate of 19.4 to 56%.~     Unfortunately, repeat hepatectomy can be performed only in a small proportion of patients~     with HCC recurrence (10.4 to 31%), either because of the poor functional liver reserve or~     because of widespread recurrence. Radiofrequency ablation has been considered to be one of~     the most effective percutaneous ablations for early-stage HCC in patients with or without~     surgical prospects. Studies using RFA to treat HCC recurrence after hepatectomy have reported~     a 3-year survival rate of 62% to 68%, which is comparable to those achieved by surgery. RFA~     is particularly suitable to treat HCC recurrence after hepatectomy because these tumors are~     usually detected when they are small, and because RFA causes the least deterioration of liver~     function in the patients. However, according to our previous study, investigators found the~     recurrent rate after RFA was higher than 60%. Systemic chemotherapy is considered to be one~     of the main treatments for malignant tumors. HCC is known to be highly refractory to~     conventional systemic chemotherapy because of its heterogeneity and multiple etiologies.~     Before the advent of the molecular-targeted agent sorafenib, which has subsequently become~     the standard of care, no standard systemic drug or treatment regimen had shown an obvious~     survival benefit in HCC. Nowadays, there is no systemic chemotherapy regimen had been~     definitively recommended as the standard for treating HCC. Clinical activity of several~     regimens containing oxaliplatin (OXA) in advanced HCC had been demonstrated in phase II~     studies. In a phase II study of the FOLFOX4 (infusional fluorouracil [FU], leucovorin[LV],~     and OXA) regimen in Chinese patients with HCC, median overall survival (OS) was 12.4 months,~     mean time to progression was 2.0 months, and the response rate (RR) was 18.2%. The safety~     profile was acceptable. Recently, the results of a phase Ⅲ randomize study showed that~     FOLFOX4 served as palliative chemotherapy can induce higher overall survival,~     progression-free survival and response rate comparing to doxorubicin in patients with~     advanced hepatocellular carcinoma from Asia. The safety data was also acceptable. Therefore,~     investigators considered RFA to be an effective treatment for HCC recurrence after curative~     treatment. So our hypothesis is that RFA combined with FOLFOX4 can reduce high recurrence~     rate after RFA for recurrent HCC after hepatectomy. The aim of this open-lable, single~     prospective study is to evaluate the efficacy and safety of RFA combined with FOLFOX4~     systemic chemotherapy for recurrent HCC after partial hepatectomy.~   "
87141|NCT02426437|"~     Chronic obstructive pulmonary disease (COPD) is a chronic lung disease primarily caused by~     smoking. COPD creates a tremendous burden to the healthcare system, as disease exacerbations~     result in frequent, prolonged hospitalizations. While originally considered a disease~     specific to the lung, data has shown that COPD is associated with substantial cardiovascular~     (CV) morbidity and mortality. Exacerbations of COPD requiring hospitalization result in~     marked patient deterioration, and heightened CV risk. The cause of the increased CV risk with~     stable COPD, and the exaggerated CV risk during exacerbations of the disease are unknown;~     however, it may be due to chronic inflammation which is exacerbated with a flare-up of the~     disease, and/or chronic inactivity which is similarly worsened with bed-rest during a~     hospitalization. Despite the impact of COPD on healthcare, there are relatively few studies~     examining how COPD inpatient care impacts on patient outcomes, inflammation and CV risk.~     Disease management programs, such as pulmonary rehabilitation and patient self-management~     education, are part of guideline therapy for COPD; however, these are not regularly~     implemented following a hospitalization, and how these interventions affect patient outcomes,~     behavior, physical activity, inflammation and CV risk have not been well studied. The~     proposed long-term project will examine how early referral to chronic disease management~     programs after hospital discharge, affect patient outcomes. This study will provide~     invaluable information about outpatient management for a disease which has a tremendous~     impact on healthcare.~   "
87142|NCT02426424|"~     This is a prospective randomized open label trial with control-to-treatment cross-over. The~     investigators wish to assess the effectiveness and safety of immediate detection and~     treatment for Sleep Apnea in Stroke patients. The investigators hypothesize that in patients~     with acute ischemic stroke a sleep apnea treatment by CPAP will result in a better~     neurological outcome and more successful rehabilitation.~      The study will enroll 140 subjects which will be randomized into one of two arms:~        -  Investigational - The sleep study will be performed during the index hospitalization~          with acute stroke. Following the diagnosis of sleep apnea, patients will be treated with~          C-PAP both during the hospital stay and after discharge.~        -  Control group -Will receive standard medical care. Patients will undergo sleep study at~          3 months following discharge and patients diagnosed with sleep apnea will be treated~          with C-PAP.~   "
87143|NCT02426411|"~     The study is a randomized, double blind, placebo-controlled, parallel-group comparison (two~     dose levels of EMA401 versus a placebo group), of safety and efficacy in patients with~     postherpetic neuralgia.~   "
87144|NCT02426398|"~     This is a non-invasive study investigating whether EEG, which is used in routine clinical~     care can be useful in diagnosing dementia. Novel in house developed software will analyse EEG~     data for this purpose from people with Alzheimer's disease and healthy volunteers.~   "
87148|NCT02426346|"~     Community-based programs are needed to improve dissemination of efficacious treatment for~     adolescent obesity. The current study aims to modify a community-based program, delivered~     through the YMCA, to increase its effectiveness with adolescents. Adolescents will be~     randomized to either a 16-week standard program (JOIN) or a targeted intervention tailored~     for adolescents (TEEN JOIN). Primary outcomes include changes in BMI, objectively measured~     physical activity, and self-efficacy, assessed at 4 months and 10 months following~     randomization.~   "
87149|NCT02426333|"~     The purpose of this study is to explore whether early abiraterone exposure is related to~     treatment response in patients with metastatic castration resistant prostate cancer.~     Furthermore to explore the relation between biomarkers and treatment response and drug~     exposure.~   "
87150|NCT02426320|"~     The purpose of this study is to estimate the hypothesized benefit of sedation interruption~     protocol on mechanical ventilation duration and PICU length of stay. The study will evaluate~     recruitment rates, and adherence rates of such protocol.~   "
87151|NCT02426307|"~     TAVR is an increasingly used technique for the treatment of aortic valve stenosis. However,~     recent clinical experience has suggested that subclinical aortic valve bioprosthesis~     thrombosis may occur early after valve replacement. The frequency of this potentially ominous~     phenomenon on both transcatheter and surgical aortic valve bioprosthesis is unknown, as this~     condition is difficult to detect.~      The recent development of cardiac 4D computed tomography imaging (4DCT) shows great promise~     for the evaluation of valve leaflet mobility and morphology.~      The purpose of this study is in an observational design to assess the frequency of~     subclinical abnormal leaflet motion and morphology in patients treated with transcatheter or~     surgical aortic valve bioprosthesis. In addition, the 'natural evolution' of this phenomenon~     as well as its relation to medical treatment and MACCE will be assessed.~   "
87152|NCT02426294|"~     The purpose of this study is to compare the treatment effect at week 26 between the two~     groups, sulfonylurea (SU, glimepiride) administration and thiazolidinedione (TZD,~     Pioglitazone) administration, as the third-order drug among patients whose treatment is not~     sufficient after the combined administration of Metformin and Alogliptin.~   "
87153|NCT02426281|"~     Nab-paclitaxel (interchangeable with ABRAXANE and ABI-007) is a unique protein formulation of~     a noncrystalline, amorphous form of paclitaxel in an insoluble particle state. Nab-paclitaxel~     was designed to improve the chemotherapeutic effects of paclitaxel by exploiting endogenous~     transport pathways to deliver higher doses of paclitaxel to the tumor and to reduce the~     solvent-related hypersensitivity and other toxicities associated with Taxol® (paclitaxel)~     injections, the solvent Cremophor EL, and ethanol vehicle. Nab-paclitaxel provides more rapid~     tissue distribution and increased tumor accumulation compared to cremophor-EL paclitaxel.~     Mechanistically, albumin receptor-mediated transport across the endothelium, binding to~     interstitial proteins, and macropinocytic or receptor-mediated uptake into tumor cells as~     well as sequestration of paclitaxel by cremophor-EL may contribute to the observed~     differences. Furthermore, nab-paclitaxel synergizes with gemcitabine in preclinical models.~     The Cremophor EL-free medium enables nab-paclitaxel to be given at a higher dose and in a~     shorter duration without the need for premedication to prevent solvent-related~     hypersensitivity reactions. As of March 2014, nab-paclitaxel is approved under the trade name~     of ABRAXANE in over 45 countries/regions, including the US, Canada, India, European~     Union/European Economic Area, South Korea, China, Australia, Bhutan, United Arab Emirates,~     Nepal, New Zealand, Japan, Russia, Sri Lanka, Argentina, Hong Kong, and Lebanon for the~     treatment of patients with metastatic breast cancer. ABRAXANE is also approved for the~     first-line treatment of locally advanced or metastatic non small cell lung cancer (NSCLC) in~     the US, Japan, Argentina, Australia, and New Zealand, for treatment of advanced gastric~     cancer in Japan, and for first-line treatment of metastatic adenocarcinoma of the pancreas in~     the US, EU/EEA, Australia, New Zealand and Argentina.~   "
87154|NCT02426268|"~     The purpose of this study is to measure cerebral and lower extremity oximetry on patients~     during cardiac surgery.~   "
87155|NCT02426255|"~     The purpose of this observational epidemiological study is to investigate the management and~     the complications associated with severe trauma. Data will be analysed to answer pre-defined~     scientific projects and to improve management of these conditions.~   "
87156|NCT02426242|"~     Severe brain-injured patients require prolonged mechanical ventilation. Weaning these~     patients from mechanical ventilation is challenging. During neurologic recovery, brain~     injured patients usually present satisfactory respiratory autonomy. However, the exact timing~     of extubation is unknown and is frequently delayed because of potential inhalation.~      To date, there are no clinical signs available in the current literature that can help the~     attending physician in the decision-making process of extubation in brain-injured-patients~   "
87157|NCT02426229|"~     This study evaluates if dabigatran etexilate is safe for use in patients with Scleroderma and~     Interstitial Lung Disease. All patients will receive 75mg of dabigatran etexilate twice a day~     for 6 months.~   "
87158|NCT02426216|"~     This is to prospectively investigate whether the chemopreventive agent, MCS, may favorably~     alter biomarker expression, whether serum carotenoids levels are associated with biomarkers~     levels, and whether the alterations of biomarker expression may reflect the cancer risk as~     shown by cancer incidence at the end of the clinical trial.~   "
87159|NCT02426203|"~     Chronic thromboembolic pulmonary hypertension causes progressive right heart hypertrophy,~     dilatation and dysfunction. Surgical treatment is pulmonary endarterectomy, which although~     only carried out in a single UK centre, provides an excellent model for assessing right~     ventricular function. Right heart function is most commonly assessed using echocardiography,~     either transthoracic pre- and post-operatively, or transoesophageal intra-operatively.~     Measurement of tricuspid annular plane systolic excursion is the best validated and most~     commonly performed measurement for right heart function, however it may be inaccurate after~     sternotomy and pericardial opening, making accurate assessment difficult immediately after~     surgery. Therefore, we aim to compare established methods of assessing right heart function~     with 3-dimensional echocardiographic reconstruction of the ventricle, using a novel~     reconstruction mechanism. Right ventricular function will be assessed in 51 patients who~     undergo pulmonary endarterectomy surgery at baseline, after the pericardium has been opened,~     following the surgical procedure, using transoesophageal echocardiography, and at six-month~     outpatient followup using transthoracic echocardiography, as 3D-reconstruction is valid using~     both modalities. This comparison should allow the investigators to determine whether such a~     method could replace current measurement parameters for assessment of right ventricular~     function, which is important for clinical management of patients in a variety of settings.~   "
87346|NCT02423759|"~     The aim of the study is to evaluate whether changing antibiotic prophylaxis from~     fluoroquinolones alone to fluoroquinolones plus gentamicin 160mg single IM dose or targeted~     antibiotic prophylaxis according to rectal swab culture would influence infectious~     complication rates in those men undergoing transrectal ultrasound-guided prostate biopsy.~   "
87160|NCT02426190|"~     The objective of the KAROS study is to compare rehabilitation outcomes between 3 proposed~     protocols and a current standard of care protocol for the purpose of identifying better~     practice for outpatient rehabilitation among patients with single total knee replacement. The~     3 advanced protocols involve use of an anti-gravity treadmill and/or the patterned electrical~     neuromuscular stimulation (PENS). Both medical modalities have been cleared by the FDA to be~     used in medical rehabilitation, including total knee replacement.~   "
87161|NCT02426177|"~     To compare effectiveness of oral labetalol and oral nifedipine for management of postpartum~     hypertension.~   "
87162|NCT02426164|"~     Liposomal bupivacaine is a novel local anesthetic designed for prolonged pain relief. Despite~     its long-acting analgesic potential, liposomal bupivacaine is significantly more expensive~     than other local anesthetic alternatives. The primary aim of this investigation is to examine~     whether or not liposomal bupivacaine provides superior pain relief or clinically significant~     opioid-sparing effects versus a control to justify its cost.~   "
87163|NCT02426151|"~     To Compare Pharmacokinetic and Pharmacodynamic Profiles of BEPO-A and REPO-A in Healthy Male~     Subjects~   "
87164|NCT02426138|"~     Food insecurity, defined as difficulty accessing food owing to cost, affects 1 in 5 diabetes~     patients. To address this, the investigators are conducting a pilot randomized controlled~     trial of medically tailored meal delivery (MTM). The pilot study has two specific aims:~      Aim 1: To determine the effect of receiving MTM on dietary quality for food insecure diabetes~     patients with hyperglycemia Aim 2: To determine the feasibility and acceptability of the~     program as a medical intervention and refine the program as needed for testing in larger~     studies.~      This study is a crossover randomized controlled pilot trial, where approximately 50~     participants, 25 in each arm, will be randomized to receipt of 12 weeks of MTM, to begin~     immediately, or waitlist control. After 12 weeks, the groups will crossover, with the~     waitlist control group now receiving 12 weeks of MTM. At baseline, 12 weeks, and 24 weeks,~     the participants will complete assessments of their dietary quality (HEI score), psychosocial~     measures such as diabetes distress and food insecurity, along with measures of body mass~     index, blood pressure, hemoglobin A1c, and lipids.~   "
87165|NCT02426125|"~     The main purpose of this study is to evaluate the safety and efficacy of the study drug~     ramucirumab in combination with docetaxel in participants with urothelial cancer who failed~     prior platinum-based therapy.~   "
87166|NCT02426112|"~     Chronic pulmonary disease (CLD) is the most common manifestation of HIV/AIDS among children,~     accounting for more than 50% of HIV-associated mortality. Recently, a novel form of CLD,~     affecting more than 30% of African HIV-infected older children was described by Ferrand et al~     in Zimbabwe, high-resolution CT scanning findings showed predominantly small airways disease~     consistent with constrictive obliterative bronchiolitis (OB). . Azithromycin has~     anti-inflammatory activity and treatment of CLD with this agent may lead to suppression of~     generalized immune activation.~      This specific aims of this project are to:~        1. Primary objective: To investigate whether adjuvant treatment with azithromycin results~          in improvement in lung function in HIV-infected children with chronic lung disease, who~          are stable on antiretroviral therapy.~        2. Secondary objectives:~             1. To investigate the intervention effect on mortality, exacerbations of lung disease,~               quality of life, morbidity.~             2. To investigate adverse events related to azithromycin treatment~      In total, 400 children aged 6-16 years, living with HIV and diagnosed with CLD will be~     enrolled at Harare Children´s Hospital in Harare (Zimbabwe) and Queen Elizabeth Central~     Hospital in Blantyre (Malawi). These will receive weekly treatment with azithromycin or~     placebo during 12 months. Another 100 children (50 per site) living with HIV but with no CLD~     will be enrolled as a comparison group for laboratory sub-studies.~      Lung function will be assess using spirometry and the Forced expiratory volume in the first~     minute (FEV1) will be the primary outcome. The mean change in FEV1 z-score levels will be~     compared between trial arms after 12 months of initiation of azithromycin treatment.~   "
87167|NCT02426099|"~     This is a four-week randomized controlled single blinded trial of subjects presenting with~     resistant hypertension in a specialized diabetes care unit of Cameroon. They are randomly~     assigned using the method of blocks to treatment with a daily 25mg of spironolactone or to~     routine intensification of antihypertensive regimen , all added to previous regimen with~     unchanged diet. Visits are scheduled at the start of the treatment, at weeks two and four~     following add-on therapy initiation. The primary outcome is change in office and~     self-measurement blood pressure recorded at each visit, and secondary outcomes are variations~     in serum potassium, sodium, and creatinine levels.~   "
87168|NCT02426086|"~     The purpose of this study is to evaluate the percentage of spleen (largest lymph organ in the~     body) response and symptom response of 2 dose regimens of imetelstat in participants with~     intermediate-2 or high-risk myelofibrosis (MF) who are relapsed after or refractory to Janus~     Kinase (JAK) inhibitor treatment. Key secondary endpoint includes overall survival.~   "
87169|NCT02426073|"~     A thorough characterization of glucose metabolism and inflammaging in elderly subjects will~     help determine to what extent each of these factors affects muscle mass/function and~     contributes to age-related muscle wasting. The investigators will correlate patterns of~     insulin secretion/sensitivity with muscle quality/quantity in diabetic and non-diabetic~     elderlies (≥70 years old). By comparing different groups (healthy, sarcopenic, diabetic,~     diabetic/sarcopenic), the investigators expect to identify an oxidative/inflammatory~     signature (e.g., circulating interleukins/myokines, plasma antioxidant capacity) specific~     for the sarcopenic phenotype and related to muscle insulin resistance.~   "
87170|NCT02426060|"~     The objective of this study was to determine the effects of Imrecoxib, an~     anti-infiammatory/analgesic agent that primarily inhibits COX-2 and not COX-1 at therapeutic~     doses, on the steady-state pharmacokinetic profile and hypoprothrombinemic effect of warfarin~     in healthy volunteers.~   "
87197|NCT02425709|"~     The purpose of this study is to compare the effectiveness of Tramadol and diclofenac in~     reducing pain during outpatient hysteroscopy in postmenopausal women. Postmenopausal women~     undergoing outpatient hysteroscopy in Cairo university will be divided into 3 groups, the~     first group will receive Tramadol 50 mg 1 hour before the procedure, the second group will~     receive diclofenac 50mg 1 hour before the procedure and the third will receive a placebo.~     Pain will be assessed by a visual analogue scale.~   "
87171|NCT02426047|"~     The modified Atkins diet (MAD) has been shown to be effective in treating intractable~     epilepsy. Approximately 55% of the patients started on the diet are women of childbearing age~     and women with epilepsy often have a pattern of seizures that correlates with their menstrual~     cycle, called catamenial epilepsy. The investigators have observed that despite an overall~     reduction in seizure frequency, some women on the MAD continue to have breakthrough seizures~     in a catamenial pattern. The investigators hypothesize that women with a history of~     intractable epilepsy who have been on the modified Atkins diet for at least 3 months and have~     a catamenial seizure pattern will tolerate and be compliant with the addition of a daily~     amount of betaquik® (a liquid emulsion of medium chain triglycerides) for a 10 day time~     interval starting 2 days prior to and encompassing the primary catamenial pattern.~   "
87172|NCT02426034|"~     The purpose of this single arm study is to assess the safety and efficacy of ATAN (Apatinib)~     in patients with Chemo-refractory Advanced or Metastatic Adenocarcinoma of Stomach or~     Gastroesophageal Junction in clinical practice. ATAN will be given to patients who had failed~     at least two lines of prior chemotherapy. Eligible patients will receive ATAN treatment (850~     mg qd p.o.) continually until disease progression or intolerable toxicity or patients~     withdrawal of consent, and the target sample size is 2000+ individuals.~   "
87173|NCT02426021|"~     The objective of the study is to investigate the safety, pharmacokinetics, and~     pharmacodynamic effect of a single dose of MLN1202 in healthy Japanese male adults.~   "
87174|NCT02426008|"~     The investigators suppose that adding growth factors that had been found in the female tubal~     fluid and uterus to In Vitro single step culture media for human embryos might improve the~     the embryogenesis In Vitro and the clinical outcome of the resulting off spring.~   "
87175|NCT02425995|"~     Peroperatively observative study in pediatric orthopedic center in Lyon, France.~      50 pediatric patients included in this study, to improve the diagnosis of hidden lesions of~     the medial meniscus associated with lesions of the anterior cruciate ligament.~      All the patients need a reconstruction of the ACL because of chronic knee instability.~      All the patients underwent a multi portal arthroscopy during the ACL reconstruction :~     anteromedial and anterolateral and after intercondylar and posteromedial.~      The study consists in a peroperatively arthroscopic look, in order to diagnose lesions of the~     posterior horn of the medial meniscus which could be missed in MRI and anteromedial and~     anterolateral arthroscopy.~      Statistics of this lesions are used to study prevalence and diagnosis capacity of this~     procedures.~      First, the surgeon did a classic knee arthroscopy. Secondarily, he did an intercondylar~     portal and after a posteromedial portal.~   "
87176|NCT02425982|"~     The study aims to investigate the natural course and the results of operative treatment of~     chronic tennis elbow (TE). Chronic is defined as symptoms having lasted for more than a year.~     The investigators will also study the effect of pain catastrophising on the subjective~     outcome, the patient acceptable symptomatic state and the response shift phenomenon in TE.~     The study will also ascertain the feasibility of a multi-center randomised, controlled trial~     (RCT), and test and refine the co-operation and interaction of the planned RCT centers.~   "
87177|NCT02425969|"~     In this randomised controlled trial of patients with stable angina and documented~     intermediate coronary disease with indeterminate or grey-zone Fractional Flow Reserve (FFR)~     we will randomise patients to either optimal medical therapy alone versus optimal medical~     therapy with PCI and they will be followed up for the primary endpoint of anginal control as~     measured by the Seattle Angina Questionnaire at 3 months.~   "
87178|NCT02425956|"~     This study is being conducted to build a library of prospectively collected clinical data~     from subjects with iron overload examined with commercially available MRI devices. This data~     library is intended for use in future engineering development and other research activities,~     including future regulatory submissions.~   "
87179|NCT02425943|"~     Study is designed to~        1. to assess the long-term safety of Sculptra Aesthetic in immune-competent subjects as a~          single regimen for correction of wrinkle assessment score (WAS) 2 to 4 nasolabial fold~          (NLF) contour deficiencies and other facial wrinkles in which deep dermal grid pattern~          (cross-hatch) injection technique is appropriate.~        2. to evaluate the time to onset, duration, severity, relationship to Sculptra Aesthetic~          and/or injection procedure, and outcome of all adverse events during the course of the~          study, by Fitzpatrick skin type.~        3. to evaluate the change in the WAS from baseline to post-treatment follow-up time points~          at Months 6, 13, and Years 2, 3, 4, and 5 in NLFs and other facial wrinkles.~        4. to evaluate Investigator/subject global assessments at Months 6, 13, and Years 2, 3, 4,~          and 5.~   "
87180|NCT02425930|"~     This study is designed to investigate whether complement C3 depletion is associated with poor~     short-term outcomes in postoperative patients with gastric cancer.~   "
87181|NCT02425917|"~     This study is designed to compare the effect of IPC on post-operative circulation in lower~     limbs with gekoTM device after total hip replacement procedure.~   "
87182|NCT02425904|"~     This research study is evaluating a drug called clofarabine as a possible treatment for~     Langerhans Cell Histiocytosis( LCH )~   "
87183|NCT02425891|"~     This multicenter, randomized, double-blind study will evaluate the efficacy, safety, and~     pharmacokinetics of atezolizumab (MPDL3280A) administered with nab-paclitaxel compared with~     placebo in combination with nab-paclitaxel in participants with locally advanced or~     metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy~     for metastatic breast cancer (mBC). The safety of single-agent nab-paclitaxel has been~     determined in previous studies of participants with mBC and the safety data to date suggest~     that atezolizumab can be safely combined with standard chemotherapy agents.~   "
87184|NCT02425878|"~     Demonstrate an 15% increase in the rate of clinical pregnancy in women with inoperable~     intramural fibroids not distorting the uterine cavity within a program OVD, after~     administration of uPA in a dose of 10 mg orally daily for 12 weeks~   "
87198|NCT02425696|"~     The purpose of the study is to evaluate the prevalence and extent of right-to-left shunt~     (RLS) in Chinese migraineurs, and the morbidity of silent cerebral infarction in migraineurs.~   "
87199|NCT02425683|"~     This study, for patients who have Stage IIIC colorectal cancer and who underwent~     5-fluorouracil/leucovorin with oxaliplatin (FOLFOX) chemotherapy after surgery, will test to~     see if regorafenib given after the completion of FOLFOX improves treatment, compared to~     standard of care (SOC), which is no further treatment.~   "
87185|NCT02425865|"~     PHASE: IV~      TYPE OF STUDY: With direct benefit~      DESCRIPTIVE: multicenter, open-label, uncontrolled trial~      INCLUSION CRITERIA: Adults with moderate to severe ulcerative colitis who failed~     corticosteroids and immunosupressive therapy, or are intolerant to immunosuppressors. All~     included patients will be naïve to anti-TNF therapy. Active disease at golimumab treatment~     initiation defined as a MAYO score ≥6 and with an endoscopic sub score ≥2.~      OBJECTIVE: To determine the proportion of patients with continued clinical response (CCR) and~     endoscopic remission at week 108, after discontinuation or de-escalation of golimumab~     treatment at year 1 in the subgroup of patients in continuous clinical response (CCR) and~     with mucosal healing (MH) (endoscopic Mayo score of 0 or 1) at week 54.~      STUDY DESIGN:~      Induction Phase :~      Week 0: golimumab 200mg- Week 2: golimumab 100 mg- Week 6: golimumab 50 mg~      Phase I : Week 10-Week 54 • Patients with primary clinical response* : Standard regimen with~     golimumab 50 mg Q4W (or 100 mg Q4W if > 80 kg)~      • Patients without primary clinical response* : Optimization to 100 mg Q4W (or combination~     therapy with azathioprine if > 80 kg or switch from azathioprine to methotrexate if already~     on azathioprine at golimumab initiation or patient with known intolerance to thiopurines)~      • Early escape at Week 18: Primary non-responders who are still not responding at week 18 to~     dose optimization at Weeks 10 and 14 will be considered treatment failures and will be~     followed up (call or visit) at week 54 for safety.~        -  Clinical response is defined as a decrease from baseline in the Mayo score ≥30% and ≥3~          points, accompanied by either a rectal bleeding sub score of 0 or 1 or a decrease from~          baseline in the rectal bleeding sub score ≥1~      Phase II : Week 54-Week 108~      • Patients with CCR and MH at week 54 and on golimumab 50 mg every 4 weeks: Stop golimumab~     and continuation of thiopurines or methotrexate if on combination therapy~      • Patients with CCR and MH at week 54 and on golimumab 100 mg every 4 weeks: De-escalation to~     50 mg every 4 weeks and continuation of thiopurines or methotrexate if on combination therapy~      • Restart/Escalate golimumab on flare (defined in section 4 of the protocol) to the phase I~     dose; 50 mg q4wk or 100mg q4wk (similar to the phase I regimen)~   "
87186|NCT02425852|"~     PHASE : IV TYPE OF STUDY : With direct benefit. DESCRIPTIVE : Multicentre, randomized, open~     label study. INCLUSION CRITERIA : Acute severe ulcerative colitis. OBJECTIVES : To compare~     the efficacy and safety of early administration of the combination therapy with infliximab~     and azathioprine with steroids and azathioprine in patients with acute severe ulcerative~     colitis treated with intravenous steroids.~      STUDY TREATMENTS : All patients :~      Intravenous steroids (0.8 mg/kg/day of methylprednisolone or equivalent) for 5 days.~      Combination therapy arm:~      Infliximab 5 mg/kg plus Azathioprine 2-2.5 mg/kg/day.~      Azathioprine arm:~      Steroids tapering for 3 months and Azathioprine 2-2.5 mg/kg/day.~   "
87187|NCT02425839|"~     Diagnoses and follow up of muscles diseases lack imaging. Severity assessment of masticatory~     dysfunction and follow up of treatment effectiveness is currently based only on clinical~     features. Supersonic ShearWave Imaging® is a new, non-invasive, non-irradiating and dynamic~     imaging technique that uses ultrasound and allows shear wave elastic modulus in a muscle in~     order to study its viscoelastic properties.~      In this study, the investigators study the correlation between changes of shear wave~     elastography modulus and surface electromyogram features of the masseters between rest and~     maximal voluntary contraction.~   "
87188|NCT02425826|"~     This study will evaluate the clinical efficacy, the patients quality of life, and safety of~     oral apremilast 30 mg twice daily (BID) compared to placebo, in adult patients with moderate~     plaque psoriasis during the 16 week Placebo controlled Phase and then upto 1 year in the~     Extension Phase of the trial.~   "
87189|NCT02425813|"~     This phase II trial studies how well methylprednisolone sodium succinate works in treating~     patients with graft-versus-host disease (GVHD) of the gastrointestinal tract that has begun~     within 100 days of transplant (acute GVHD). Corticosteroids are a type of drug that reduces~     inflammation. Giving corticosteroid drugs, such as methylprednisolone sodium succinate,~     directly into the arteries of the gastrointestinal tract may help treat inflammation caused~     by GVHD. Giving methylprednisolone sodium succinate in addition to standard treatments may be~     more effective in treating GVHD.~   "
87190|NCT02425800|"~     This pilot research trial studies the use of a human prostate tissue model to maintain and~     study prostate cancer stem cells. A human prostate tissue model uses leftover tissue that was~     removed during surgery from patients with non-cancerous enlargement of the prostate (benign~     prostatic hyperplasia) and may create an environment similar to the natural environment of~     the human body. Prostate cancer stem cells are cells that cause cancer to grow. Using real~     tissue to create an environment to study stem cells may help doctors learn more about how~     they work and how they respond to treatments.~   "
87191|NCT02425787|"~     Recent focus groups at St. Jude Children's Research Hospital (SJCRH) revealed several~     limitations in our understanding of how parents' relationships with care staff help and~     hinder their grief experience. Additionally, there is a gap in the bereavement literature~     regarding the psychological effects professional caregiver relationships have on parents~     whose children died of cancer. To bolster our knowledge base and benefit Bereavement Care~     Services at SJCRH, as well as benefit other professionals by filling the gap in the~     literature, we have designed a qualitative study that will conduct individual interviews with~     bereaved parents whose children died at SJCRH.~      Validation of the preliminary analyses of the initial 30 interviews will occur through new~     focus groups involving two separate sets of bereaved parents who will validate the findings~     and/or suggest additional avenues of inquiry needed to gain a more complete understanding of~     parental grief/bereavement experience. Additionally, focus groups with hematology/oncology~     fellows will obtain provider feedback on the value of these findings in their training and~     future role as physicians.~   "
87192|NCT02425774|"~     Hypothesis:~      Prucalopride can mimic electrical stimulation of the abdominal vagus nerve and has an~     anti-inflammatory effect.~      Aims:~      In the present pilot study, the investigators want to evaluate the anti-inflammatory effect~     of prucalopride. The following aims are formulated:~        1. to show that prucalopride has a similar inflammatory effect as abdominal vagus nerve~          stimulation (VNS)~        2. to evaluate whether prucalopride leads to accelerated post-operative recovery~   "
87193|NCT02425761|"~     The purpose of the study is to compare the survival time (time to first shunt failure) of~     ventriculoperitoneal (VP) shunts inserted through an anterior entry site with those inserted~     through a posterior entry site in children. Shunt entry site is the location on the head that~     the shunt catheter enters the brain on its path to the fluid-filled spaces in the brain, the~     ventricles. Entry sites can be anterior or posterior.~   "
87194|NCT02425748|"~     In this study, effects of γδT cells on human non small lung cancer ( without EGFR mutation)~     in combination with tumor reducing surgery, for example cryosurgery going to be investigated.~   "
87195|NCT02425735|"~     In this study, effects of γδT cells on human hepatocellular liver cancer in combination with~     tumor reducing surgery, for example cryosurgery going to be investigated.~   "
87196|NCT02425722|"~     The objective of this study is to investigate dose-responses of efficacy and safety of~     ASP0456 in patient with chronic constipation (diagnosed by Rome III criteria of FC, not~     including constipation due to organic diseases) compared to placebo and to investigate the~     appropriate dose range for P3 study.~   "
87200|NCT02425670|"~     The purpose of this study is to determine whether patients with subacute ischemic stroke will~     benefit from infusion of patient's own bone marrow derived stem cells.~      Primary Hypothesis: Intravenous injection of bone marrow mononuclear cells at a dose of 30 to~     500 million in patients with subacute ischemic stroke results in reduction of infarct volume~     and improvement of neurological function compared to those without the injection.~      Secondary Hypothesis: Patients receiving more than 100 million Bone marrow derived stem cells~     (BMSC) will have better outcome than those receiving fewer dosages of cells.~   "
87201|NCT02425657|"~     Specially educated trainers will be responsible for colonoscopy training of junior doctors.~     The educated trainers will have attended seminars held by Valori et al.~      The following fast track colonoscopy training program for junior doctors will consist of: 1)~     Endoscopy simulation training and theory course 2) supervised and partly supervised lower~     endoscopy. 3) Directly observed practical skills according to JAG (joint advisory group)~     guidelines.~   "
87202|NCT02425644|"~     International clinical trial to compare ponesimod and teriflunomide in relapsing multiple~     sclerosis~   "
87203|NCT02425631|"~     This study will evaluate long-term follow-up of subjects implanted with the SImmetry~     Sacroiliac (SI) Joint Fusion System (SImmetry).~   "
87204|NCT02425618|"~     The purpose of this study is to investigate whether the pressure controlled ventilation can~     reduce gastric insufflation compared to the volume controlled ventilation in patients who~     were mechanically ventilated with the i-gel.~   "
87205|NCT02425605|"~     This is a single-center, single-arm, open-label, prospective phase 2 trial to assess the~     efficacy of localized concurrent chemoradiation therapy (CCRT) and sorafenib sequential~     therapy in subjects with advanced HCC. Approximately 47 subjects will be enrolled and will~     receive CCRT and sorafenib sequentially until all-cause mortality.~   "
87206|NCT02425592|"~     The objective in this study is to determine if MRI-identified progression can decrease~     frequency or need for repeated prostate biopsy in men on active surveillance (AS).~      Our hypothesis is that MRI alone is adequate to detect progression of prostate cancer in men~     on active surveillance (AS) after a MRI-US fusion prostate biopsy.~   "
87207|NCT02425579|"~     The purpose of this study is to assess the safety of inhaled carbon monoxide (iCO) in~     intubated patients with sepsis-induced ARDS.~   "
87208|NCT02425566|"~     The purpose of this study is to better understand the role of the abdominal veins (splanchnic~     capacitance) and the sympathetic nervous system in human hypertension. The investigators will~     test the hypothesis that constriction of abdominal veins due to sympathetic activation~     contributes to human hypertension. Splanchnic capacitance will be assessed in normotensive~     and hypertensive subjects at baseline and during acute blockade of the autonomic nervous~     system.~   "
87209|NCT02425553|"~     Reflux and dyspeptic symptoms are common affecting 10-20% of the population on a regular~     basis. Reflux symptoms such as heartburn and regurgitation are caused by the return of acid~     or non-acid gastric contents into the esophagus. Dyspeptic symptoms are caused by abnormal~     gastric relaxation (impaired accommodation) or increased sensitivity of the stomach to~     distension during the meal.~      The effects of diet on gastrointestinal function are debated and the efficacy of dietary~     management for digestive symptoms has not been established. Epidemiological studies suggest~     an effect; however, it is not possible to distinguish the effects of fat intake and total~     energy (i.e. calorie) intake in this work. This issue has been addressed by small~     physiological studies. The results show that esophageal acid exposure was related to total~     calorie intake but not to fat content. In contrast, the number of reflux symptoms was 40%~     higher after the high-fat than the low-fat meals. Similar findings were found for the~     relationship between gastric distension, fullness and dyspeptic symptoms by Magnetic~     Resonance Imaging. Thus, it appears that fat does not cause digestive dysmotility but~     heightens sensitivity to visceral events and so increases the number and severity of symptoms~     reported by patients. As yet, these findings have not been confirmed in larger, more~     representative surveys.~      Similar to the effects of food, there are inconsistent findings regarding the effects of~     alcohol on gastro-esophageal reflux (GER) and gastric function. Physiological studies have~     noted delayed gastric emptying and an increase in reflux events when alcohol is taken with~     food. However, larger surveys have not confirmed that alcohol triggers reflux or dyspeptic~     symptoms.~      The proposed observational, dietary study with cross-over design will assess the independent~     effects of energy intake (i.e. calorie load) and fat intake on gastric fullness, the number~     and severity of reflux and dyspeptic symptoms after meals. The effect of alcohol on symptoms~     after the high calorie, high fat meals will also be documented. The study population of~     senior academics attending a conference are likely to have a relatively high prevalence of~     risk factors for gastro-esophageal reflux disease (GERD) being predominantly male, with an~     older age and a larger waist circumference than average in the general community. This will~     increase study power and relevance of the findings.~      The results will provide new information concerning the impact of dietary factors and alcohol~     on digestive symptoms after meals. This data will inform future guidelines for the dietary~     management of patients with reflux and dyspeptic symptoms after meals which will be relevant~     in both primary and secondary care.~   "
87210|NCT02425540|"~     The aim of the study is to prospectively evaluate the value of pelvic MRI including~     diffusion- and perfusion-weighted sequences in the selected group of patients that have an~     undetermined ovarian mass at ultrasound.~   "
87211|NCT02425527|"~     The purpose of this feasibility study is to determine whether digital games are effective and~     acceptable in the treatment for patients with traumatic brain injury.~   "
87212|NCT02425514|"~     The purpose of this study is to evaluate the efficacy and safety of NovoMax™ in Anterior~     Cervical Interbody Fusion - Comparison of NovoMax™ versus ChronOs®.~   "
87213|NCT02425501|"~     The objectives of this study are to investigate the safety and effectiveness of EYLEA~   "
87214|NCT02425488|"~     Purpose: Heart Failure (HF) is a clinical multifactorial syndrome, it can cause arrhythmias~     for which international guidelines suggest the implantation of an implantable cardiac~     defibrillator (ICD). The educational nursing program would improve clinical outcomes in~     patients with HF and ICD like control their sickness, known and acknowledge symptoms, improve~     their skills to self-care.~      The main aim of this study is to assess how much the nursing-therapeutics skills and an~     educational intervention, in patients with HF during the follow-up period after the~     implantation of ICD reduces clinical costs, re-hospitalizations, and mortality at 180 days.~      Methods: The investigators start a multicenter randomized clinical trial. The sample is made~     of 128 subjects (64 patients treatment group and 64 control group). The investigators~     measured the self-care level administering to HF patients the Self-Care of Heart Failure~     Index (SCHFI) v. 6.2, and the self-perception of own life quality using a Numeric Rating~     Scale from 0 to 100. Secondary outcomes recorded are i) the numbers of accesses to the ED~     (Emergency Department) and/or hospitalizations during the follow-up period, ii) mortality~     rate due to HF, and iii) infection rate of the device pocket.~      Data Analysis: Categorical variables will be presented in terms of frequencies and~     percentages. The statistical power was fixed at the 80%. Data will be considered significant~     for a p-value ≤ 0.05. The Cox proportional hazards model will be used to analyze mortality in~     subjects involved in the educational program.~   "
87215|NCT02425475|"~     All patients will undergo dermoscopic diagnosis and be documented with a video image storing.~     The diagnosis based on dermoscopy will be immediately documented. Then, as a second~     diagnostic procedure, fluorescence diagnostics based on the two photon excitation from a~     dye-laser will be performed. The classification as non-melanoma or malignant melanoma by the~     medical device LIMES will also be documented immediately. Afterwards, the lesion will be~     excised and undergo histopathologic examination by the respective histopathologist of the~     participating centers. The histopathologic diagnosis will serve as gold standard for~     subsequent evaluations of the diagnostic accuracy.~   "
87216|NCT02425462|"~     This study is a prospective observational cohort study. The study will be conducted in~     routine clinical practice settings. It is planned to enroll 870 patients with endometriosis~     for whom a decision has been made by the physician to treat with dienogest according to local~     health authority approved label. It is the aim of this observational cohort study to further~     characterize the effectiveness of dienogest in improving quality of life and long-term safety~     in routine clinical practice setting. Endometriosis is chronic and progressive disease and~     there is unmet need for long-term treatment. Visanne® with proven efficacy and safety, can be~     good option for long-term treatment, however, experience with Visanne® beyond 15 month is~     limited. And long-term up to 24 months data on effectiveness and safety of Visanne would~     support the long-term treatment strategy for Endometriosis management in the clinical~     practice.~   "
87217|NCT02425449|"~     Muscle relaxants are medications used during surgery to facilitate surgical access. The~     effect of the muscle relaxant medications is measured by stimulation a motor nerve and~     measuring the force of the resultant muscle contraction. Based on the mechanism of action,~     two kinds of muscle relaxants are described. First a nondepolarizing muscle relaxant and the~     second kind is the depolarizing muscle relaxant. These two kinds of muscle relaxants can be~     distinguished by rapidly stimulating the nerve 4 times over 2 seconds (Train of four or TOF).~     The nondepolarizing muscle relaxants produce fade ie successive muscle contractions are less~     forceful than the preceding ones. Whereas the depolarizing muscle relaxants are generally~     believed to produce four contractions of equal strength. However, there is some indication~     that this may not be entirely correct. There is evidence that depolarizing muscle relaxants~     also may produce fade. The investigators are conducting the following study to determine if~     indeed depolarizing muscle relaxants produce fade. The investigators would also like to~     characterize the fade ie differences during onset and offset of the block and the effect of~     the dose on the degree on the fade.~   "
87218|NCT02425436|"~     The use of herbal medicinal products is increasing enormously in recent years, mainly among~     women, who use them for the most varied purposes, such as in menstrual problems, menopausal~     symptoms, mood disturbances and to strengthen their bones. Most of these benefits are due to~     the flavonoids present in these products. These flavonoids have anticarcinogenic, antiviral,~     antioxidant and antiinflammatory activities, as well as being used in the treatment of~     osteoporosis, menopausal symptoms and cardiovascular diseases . Besides the benefits from the~     consumption of flavonoids, little is known about their safety and potentially harmful toxic~     effects, such as mutagenicity and genotoxicity which might occur if taken in large doses .~     Safety of Ginkgo biloba during pregnancy or lactation was not criticized in literature.~     Roasted and raw ginkgo seed were not reported in the evidence-based medicine literature as~     being either safe or contraindicated in pregnancy or lactation. A higher incidence of~     postpartum hemorrhage was reported in the literature when associated with a 3-month ingestion~     of Ginkgo Biloba extract. Flavonoids are components of Ginkgo biloba L. (Ginkgoaceae), a~     medicinal plant widely used by the population . G. biloba has its origin in China, Korea and~     Japan where its fruits and leaves have been used as food and medicine for a long time.~      The extract of G. biloba (EGb) is composed of different terpene trilactones, i.e.,~     ginkgolides A, B, C, J and bilobalide, many flavonol glycosides, biflavones and alkylphenols~     . The major flavonoids in the extract are kaempferol, quercetin and isorhamnetin] whose~     metabolites were found in the blood of rats and in human urine after oral administration of~     EGb. Due to its actions as an anti-inflammatory and antioxidant, EGb has been largely used in~     the treatment of Alzheimer's disease, pre-menstrual syndrome, cerebrovascular insufficiency~     and peripheral arterial occlusive disease . In folk medicine, EGb is used as a vermifuge, to~     induce labor, for the treatment of bronchitis, chronic rhinitis, chilblains, arthritis and~     edema . The aim of this study was to evaluate the effect of oral supplementation of Ginkgo~     Biloba extract on the fetal weight as well as feto-maternal blood flow in cases of~     intrauterine growth restriction.~   "
87219|NCT02425423|"~     The aim of this study is to evaluate the efficacy of a new thickened formula on~     regurgitation.~   "
87220|NCT02425410|"~     The purpose of this study is to investigate viral factors determining the early onset of T1D.~     Thanks to the quantification of viral exposures of T1D patients before the disease onset with~     questionnaires and environmental databases analyses, and through whole genome association~     studies of these patients, investigators could attempt to identify gene-virus interactions~     determining the age of T1D onset.~   "
87221|NCT02425397|"~     A limited number of relatively contradictory studies have suggested that the development of~     serious ototoxicity in children treated with cisplatin or, more rarely, carboplatin could be~     partly related to genetic risk factors affecting detoxification enzymes and membrane~     transporters of platinum derivatives. The objective of this study is therefore to identify~     genetic variants associated with the development of platinum ototoxicity in patients treated~     with cisplatin or carboplatin (minimum follow-up of 3 years) for one of the following~     diseases: neuroblastoma, hepatoblastoma, retinoblastoma, malignant germ cell tumour,~     osteosarcoma, high-risk or recurrent Wilms' tumour, non-parameningealrhabdomyosarcoma. A~     total of 180 patients, corresponding to 60 cases with grade 3 or 4 ototoxicity and 120~     controls with no signs of ototoxicity (separate complete audiograms for each ear) will be~     included. A saliva sample will be used to obtain DNA for pharmacogenetic studies. The value~     of this study will be to define a population at high risk of developing ototoxicity in order~     to adapt treatment, or even develop preventive treatment of ototoxicity based on antioxidant~     medications~   "
87222|NCT02425384|"~     The primary objective of this protocol is to test whether an activity monitor with an online~     motivational rewards component will increase physical activity levels of middle school-aged~     students. The secondary objective is to learn about the functionality and utilization of the~     activity meter device among this age group.~   "
87237|NCT02425189|"~     The NLQTS Research Network team aims to build a Canadian collaboration of dedicated~     investigators that will create a new paradigm in the modern investigation of patients with~     LQTS and in the description of a new disease modifier.~      The project aims to describe the natural history of familial Long QT Syndrome to identify:~        1. Low risk patients that do not require protective beta-blocker therapy~        2. High-risk patients that require protective beta-blocker therapy and may benefit from a~          primary prevention ICD. This cohort would contain treated pre-symptomatic individuals~          effectively protected from harm.~   "
87223|NCT02425371|"~     Growing recognition of the importance of co-morbidities in Heart Failure with Preserved~     Ejection Fraction (HFPEF) has led to the realization that rather than being a distinct~     disease entity, HFPEF may represent a spectrum of co-morbidities in elderly breathless~     patients. Accordingly, progress in managing HFPEF in the elderly requires improved~     understanding of HFPEF pathogenesis with a focus on the impact of co-morbidities. However,~     the available evidence is insufficient to determine the true prevalence and severity of~     co-morbidities as well as their impact on both diagnosis and treatment in HFPEF. Therefore~     there are widespread diagnostic uncertainty without proven therapy!~      The purpose of this project is twofold:~        1. The investigators will study how to improve diagnostic accuracy for HFPEF in elderly~          patients, despite frequent comorbidities and higher age? How useful is it to add~          exercise testing and contrast echocardiography as well as biomarker as additional~          diagnostic tools in elderly HFPEF patients?~        2. The investigators will test the hypothesis that HFPEF in the elderly is dominated by~          multiple co-morbidities that are a major part of the syndrome itself that contribute to~          the development of HFPEF. This hypothesis implies that the treatment of co-morbidities~          will improve prognosis.~      The investigators' overall goal is to bring about a paradigm shift in managing elderly~     patients with HFPEF by not only improving diagnosis but also effectively treating~     co-morbidities that are currently considered predisposing factors to HFPEF. This contrasts~     with trials during last two decades that only target the heart.~      The investigators will pursue the following specific aims:~        1. Validate the diagnostic criteria for HFPEF proposed by European Society of Cardiology~          2012, and determine the added diagnostic values of exercise testing and contrast~          echocardiography as well as biomarker for HFPEF in a multi-center study.~        2. Determine if systematic screening and optimal management of co-morbidities associated~          with HFPEF improves the outcomes of patients with HFPEF in a randomized study.~   "
87224|NCT02425358|"~     Most studies on intracoronary bone marrow mononuclear cell (BMC) transplantation for acute~     myocardial infarction (AMI) involve treatment 3-7 days after primary percutaneous coronary~     intervention (PCI); however, the optimal timing is unknown. The present study assessed the~     therapeutic effect at different times after ST-elevation myocardial infarction (STEMI).~   "
87225|NCT02425345|"~     The WHISH trial applies state-of-the science behavioral principles and currently available~     technologies to deliver a physical activity intervention without face-to-face contact to~     ~25,000 older U.S. women expected to consent. It includes an algorithm-driven interactive~     voice response (IVR) system, built to complement the National Institute of Aging (NIA)~     Go4Life® Exercise & Physical Activity materials 3, which provides tailored advice on how to~     achieve nationally recommended levels of PA and overcome barriers to exercise, with a means~     for self-monitoring and setting personal goals. The intervention builds upon evidence-based~     behavioral science principles and intervention components that have proven to be effective in~     increasing PA in older women, with innovative adaptive approaches to tailoring the delivery~     to meet individual (personal) needs.~   "
87226|NCT02425332|"~     The aim of this study is the validation of a novel gait assessment method implemented in the~     Lokomat gait trainer with respect to established clinical gait assessment methods. The~     walking assessment method is based on the progressive reduction of the support of the device.~     The outcome measures of this algorithm will be the support needed in the different gait~     phases (guidance force of hip and knee joints) and the support required to the body weight~     support system (unloading). The hypothesis is that the guidance force and the support of the~     device will converge to a profile individual for each subject that is representative of one's~     impairment in the different gait phases. The reliability of the method will be tested~     collecting data from two sessions of Lokomat training. The validity of the method will be~     tested comparing the outcome of the assessment task with established clinical walking~     assessment measures.~   "
87227|NCT02425319|"~     The purpose of this study is to describe and to compare the motion analysis parameters, i.e.~     motion and stability of proximal interphalangeal joints, which were treated with a~     CapFlex-PIP© implant or silicone implant and to generate basic knowledge about motion~     analysis of untreated healthy hands.~   "
87228|NCT02425306|"~     This study evaluates whether it is safe to administer a peptide vaccine in combination with~     different adjuvants. Adjuvants are substances that may boost immune responses vaccines. In~     this study, the adjuvants are Montanide ISA-51, polyICLC and cyclophosphamide. This study~     will also evaluate the effects of the combination of the peptide vaccine and the adjuvants on~     the immune system. The investigators will monitor these effects by performing tests in the~     laboratory on participants' blood, a lymph node, and tissue from the sites of vaccination.~   "
87229|NCT02425293|"~     The aim of this study was to investigate the effect of standardized patient education on~     asthma control. In collaboration with two health insurance companies, pharmacists and~     pneumologists, patients with asthma were recruited. They completed the Asthma Control Test~     (ACT) and the Patient Assessment of Chronic Illness Care (PACIC 5A) questionnaire to~     assess asthma control and patients' satisfaction with the health care service they received.~     Additionally, patients were offered the possibility to participate in a patient education~     seminar run by the Swiss lung leagues or the Swiss allergy centre (aha!). After one year,~     patients were asked to complete the questionnaires again. Comparisons of intraindividual~     changes and differences regarding ACT and PACIC 5A between patients with and without patient~     education were made.~   "
87230|NCT02425280|"~     This study aims to understand how war trauma affects children's and adolescents' memory~     functions and mental health, and whether Narrative Exposure Therapy is effective in enhancing~     optimal memory functions and alleviating mental health problems. The study analyzes the~     mental health and cognitive and emotional healing mechanisms of therapeutic intervention~     among war-affected children and adolescents.~   "
87231|NCT02425267|"~     The main objective of the study is to compare the clinical effects of the innovative~     telerehabilitation approach (TELE group) compared to face-to-face visits to a clinic (CLINIC~     group) for patients treated for a proximal humerus fracture.~   "
87232|NCT02425254|"~     The purpose of this study is to test whether a dose of paracetamol given before surgical~     incision is more effective at reducing postoperative pain and analgesic consumption in~     cervical spine surgery versus a dose given at the end of surgery.~   "
87233|NCT02425241|"~     This is a clinical proof-of-concept (PoC) study of DNA vaccination after SAP depletion. The~     investigators will measure the immune responses to DNA vaccination against HIV-1 in healthy~     adult male volunteers, comparing a group in whom SAP has been completely depleted at the time~     of DNA vaccination and a control group vaccinated without SAP depletion.~   "
87234|NCT02425228|"~     This is a pilot study to determine cancer detection rate of conventional/systematic versus~     targeted biopsy methods in diagnosis of potentially lethal prostate cancer. This is a~     diagnostic trial using each patient as his own control.~   "
87235|NCT02425215|"~     Background: Radiotherapy is a common treatment for many malignancies. Radiation-related~     complications developing months or years after radiation treatment are known as late~     radiation tissue injury (LRTI) and are estimated to effect 5%-15% of all long-term survivors~     who have received radiation.~      Hyperbaric oxygen therapy (HBOT) is a well established treatment of LRTI. Most of the studies~     evaluating effect of HBOT on LRTI are focused on survival, resolution of tissue damage and~     improvement in LENT-SOMA scale. Very few studies have addressed effect of HBOT on pain in~     LTRI. Krahn and colleagues were the first to report the analgesic effect of HBOT in 3 cases~     of refractory pain in oncological patients with radiation soft tissue injury. Other studies~     showed significant improvement in pain intensity in patients with breast cancer and pelvic~     malignancies treated with HBOT for LTRI. In patients that had developed radiation- induced~     brachial plexopathy, HBOT elicited an increase in warm pain thresholds and a reduction in~     lymphoedema. A prospective case study of 16 patients with gynecological cancer found no~     changes with respect to pain and depression outcomes. A trial in patients with radiation~     induced proctopathy showed that 75% of patients with rectal pain had some improvement,~     although none experienced a complete resolution of pain symptoms.~      There are several mechanisms by which HBOT may elicit analgesic effects. There is a growing~     body of evidence that HBOT's analgesic effect related to nitric oxide metabolism and~     endogenous opioid secretion. Furthermore, the inhibition of tumor necrosis factor alph~     (TNF-α), the production of substance P, and the modulation of serotonergic pathways have all~     demonstrated a modification in the pain response following HBOT. In animal studies HBOT~     decreased allodynia and hyperalgesia in different models of neuropathic and inflammatory~     pain. The long lasting antinociceptive effect of HBOT was found to be dose-dependent in~     non-injured tissues.~      In human studies, HBOT decreased pain and edema and improved function in patients suffering~     from the complex regional pain syndrome, and improved pain scores and range of motion in~     patients with idiopathic femoral head necrosis. Women suffering from interstitial cystitis~     demonstrated a reduction in pelvic pain following weeks and months of HBOT treatment. In~     patients suffering from idiopathic trigeminal neuralgia HBOT produced a rapid reduction in~     symptoms and these effects were lasting for 6 months following treatment. HBOT was also found~     to be an effective treatment for cluster headaches and migraines and alleviated muscle and~     bone pains in patients with myofascial syndrome, fibromyalgia, and biphosphonate-related~     osteonecrosis of the jaw.~      Based on the evidence presented above and HBOT's known analgesic effect in many conditions,~     the investigators designed this study with the objective to evaluate if HBOT reduces pain,~     improves depression and impacts on patients quality of life in patients suffering from late~     radiation tissue injury.~      Study Design: Prospective observational study (n=300). Patients that have had radiation~     therapy for malignancy, developed late radiation injury and suffer from chronic pain.~   "
87236|NCT02425202|"~     The study will evaluate the post-operative morphine-sparing effect, pain reduction, and side~     effects of a continuous ketamine infusion after tonsillectomy in pediatric patients.~   "
87238|NCT02425176|"~     The efficacy of Botulinum toxin A (BoNT-A) in Asian population has not been properly studied~     and there is no literature available on the most efficacious dose of BoNT-A for sialorrhoea~     treatment. This research is aimed to find the dose of Dysport® that would be efficacious~     without treatment-related adverse events and the duration of effectiveness of the drug for~     sialorrhea treatment in Malaysian patients. The efficacy, safety, tolerability and adverse~     effects of three doses of Dysport®(50MU, 100MU and 200MU) are examined at 2,6,12 and 24 weeks~     post injection in this double-blinding, randomized trial.~   "
87239|NCT02425163|"~     Evaluation of significant Shear Wave Elastography Parameters for Prostate Biopsy and Prostate~     Cancer detection.~   "
87240|NCT02425150|"~     The purpose of this study was to determine whether mechanical compression of the cornea~     during corneal crosslinking for keratoconus using a sutured rigid contact lens can improve~     the optical outcomes of the treatment.~   "
87241|NCT02425137|"~     Primary Objective:~      To evaluate disease control rate (DCR) of S-1 in combination with gemcitabine in patients~     with advanced biliary tract cancer~      Secondary Objectives:~        -  To evaluate overall response rate (ORR)~        -  To evaluate progression-free survival (PFS)~        -  To evaluate overall survival (OS)~        -  To assess the safety profile~   "
87242|NCT02425124|"~     A pragmatic cluster randomized controlled trial (RCT) in 20 public sector primary care~     clinics in the Dr Kenneth Kaunda district of the North West Province of South Africa to~     assess mental health and health outcomes for depressed adults receiving hypertensive~     treatment by measuring the real-world effectiveness of a facility-based stepped care~     intervention combining stress and depression case detection and management by non-physician~     clinicians and referral pathways for anti-depressant medication and/or group/individual~     counselling delivered by lay-health workers for patients with depression. The control~     condition is enhanced usual primary health care where non-physician clinicians have been~     equipped with the basic skills to identify stress and depression/anxiety but with limited~     access to doctors authorized to prescribe antidepressant medication, and with no specific~     psychosocial interventions.~   "
87243|NCT02425111|"~     The purpose of this study is to evaluate endoscopic remission at Week 26 as assessed by~     ileocolonoscopy.~   "
87244|NCT02425098|"~     The purpose of this study is to assess the post-vaccination neutralizing antibody response~     against each dengue serotype by treatment arm.~   "
87245|NCT02425085|"~     Previous pilot study has demonstrated that the novel multi-endodiathermy retinectomy is~     feasible, effective and safe for inferior retinal redetachments in the silicone oil-filled~     eyes of adults over a 3-month observation.~      Here, the investigators conduct this randomized and multicenter clinical trial to compare the~     efficacy and safety between multi-endodiathermy retinectomy and relaxing retinectomy.~   "
87246|NCT02425072|"~     The hypothesis of this study is that the addition of NovoTTF-100A System treatment to salvage~     chemotherapy will significantly increase time to treatment failure in the brain of small cell~     lung cancer patients.~   "
87247|NCT02425059|"~     The purpose of this study is to evaluate the safety and efficacy of irreversible~     electroporation (IRE) for unresectable Rectal Neoplasms.~   "
87248|NCT02425046|"~     Low-income children and children of obese parents are at high risk of obesity. Effective~     interventions are needed to target these families to improve the health of the parents and~     prevent obesity in the children. The hypothesis is that an intervention that combines~     engagement of community organizations, motivational interviewing (MI, a technique proven to~     help people set goals that are personally meaningful), and resource mobilization will change~     diet and physical activity habits among disadvantaged families. This proposal grew from an~     established community-based participatory research (CBPR) partnership between the research~     team and community organizations that serve high minority (45-55%), low-income populations.~     Partners include a community health center, a food pantry network, a work-force training~     program, and other agencies. These partners designed and implemented a successful pilot~     project on which this proposal is based. The specific aims of this proposal are 1) To~     evaluate the efficacy of a family-targeted obesity intervention based on MI and~     resource-mobilization. Hypotheses: In comparison to control families, families participating~     in the intervention will demonstrate a) a reduction in BMI for adults, b) an increase in~     minutes of moderate physical activity and decreased sedentary time for both adults and~     children accelerometer), and c) a reduction in the number of obesity risk behaviors and an~     increase in obesity prevention behaviors among children. 2) To examine the mediators of~     intervention effects. 3) Identify the types of resources needed most often by intervention~     families to support lifestyle change. This randomized controlled trial includes 260~     low-income families that contain at least one obese adult and one normal or overweight child~     between 6 and 12. The 12-month intervention has two elements. 1) A health coach will use MI~     to help families explore ambivalence toward and motivations for change and set goals for~     improving diet and physical activity. 2) To support goals, families will be connected with~     community agencies that can assist with general (e.g., financial) and goal specific resources~     (e.g., food, physical activity opportunities). Collaboration between organizations will~     streamline referrals, maximize resources, and facilitate access. Control families will get a~     basic screen for needs and information about available community resources. Outcomes are~     measured at baseline, 6, 12, and 18 months. This intervention is innovative in that it 1)~     focuses on lifestyle changes for the entire family and measures outcomes in adults and~     children, 2) combines MI focused on the entire family and community resource referrals~     specific to family needs and goals for change, 3) partners community organizations to~     coordinate resources for families, and 4) involves partners in all research phases via a CBPR~     approach. This contribution will be significant because the proposed intervention, if~     successful, can be replicated elsewhere and adapted to the local resource environment to~     address adult obesity and prevent childhood obesity in a high-risk population. The study will~     also identify the types of resources low-income families need to change diet and physical~     activity.~   "
87249|NCT02425033|"~     This study evaluates the efficacy and safety of the Per-Oral Endoscopic Myotomy (POEM)~     technique for lower esophageal sphincter myotomy in patients suffering from spastic~     esophageal disorders such as achalasia at a Canadian institution.~      The investigators hypothesize that POEM is a safe and effective technique for the surgical~     management of such disorders at our institution.~   "
87250|NCT02425020|"~     The aim of this project is to investigate the potential benefits of combining a new protein~     meat hydrolysates extract with a regular resistance training programme on (a) body~     composition (b) performance (c) muscle structure (d) general markers health and immunity in~     athletes. As a second objective the investigators will analyse potential differences obtained~     from the ingestion of the new hydrolysates meat protein extract compared to the ingestion of~     others commercially available protein sources such as whey or casein.~   "
87251|NCT02425007|"~     The purpose of this study is to evaluate the efficiency of incentive spirometry in elderly.~     Outcomes are lung function and chest expansion.~   "
87252|NCT02424994|"~     The aim of this project is to study the association of a number of demographic and~     cardiovascular risk factors with death, health care utilisation and systemic embolisation by~     examining the clinical evolution of hypertrophic cardiomyopathy in a large, community based~     cohort identified from linked electronic health records.~   "
87253|NCT02424981|"~     Efficiency of inspiratory muscle training in elderly people. Outcomes are lung function,~     muscle strength and chest expansion.~   "
87254|NCT02424968|"~     This phase II trial studies how well cluster of differentiation 8 (CD8)+ memory T-cells work~     as a consolidative therapy following a donor non-myeloablative hematopoietic cell transplant~     in treating patients with leukemia or lymphoma. Giving total lymphoid irradiation and~     anti-thymocyte globulin before a donor hematopoietic cell transplant helps stop the growth of~     cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells.~     When the healthy stem cells from a donor are infused into the patient they may help the~     patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.~     Sometimes the transplanted cells from a donor can make an immune response against the body's~     normal cells (called graft-versus-host disease). Giving cyclosporine and mycophenolate~     mofetil after the transplant may stop this from happening. Once the donated stem cells begin~     working, the patient's immune system may see the remaining cancer cells as not belonging in~     the patient's body and destroy them. Giving an infusion of the donor's white blood cells,~     such as CD8+ memory T-cells, may boost this effect and may be an effective treatment to kill~     any cancer cells that may be left in the body (consolidative therapy).~   "
87255|NCT02424955|"~     Primary Objective:~      The primary objectives of this prospective pilot study is to:~        1. determine the feasibility and reproducibility of 3D contrast enhanced ultrasound imaging~          in liver cancer patients undergoing Stereotactic Ablative Radiotherapy and~        2. evaluate whether there are treatment induced early changes in imaging metrics derived~          from 3D contrast enhanced ultrasound. This study will provide valuable insight as to the~          potential of baseline and/or early post-treatment 3D ultrasound perfusion~          characteristics (measurements of blood-flow) of primary and metastatic liver tumors to~          predict tumor response to Stereotactic Ablative Radiotherapy. The investigators'~          underlying goal is to assess whether early perfusion changes at 1-7 days after SABR~          initiation can be used as a non-invasive early biomarker for treatment response~          assessment.~      Secondary Objectives:~      Evaluate the feasibility of contrast-enhanced ultrasound-to-CT fusion by assisting~     three-dimensional (3D) perfusion ultrasound (US) imaging with optical and electromagnetic~     tracking of the ultrasound probe on patients with liver cancer that will undergo CT for~     treatment planning and/or response evaluation.~   "
87256|NCT02424942|"~     Primary Objective:~      To assess the safety and tolerability of ascending single intraarticular doses of GZ389988 in~     patients with painful osteoarthritis (OA) of the knee.~      Secondary Objectives:~      To assess the pharmacokinetic (PK) parameters of ascending single intraarticular doses of~     GZ389988 in patients with painful OA of the knee.~      To obtain preliminary pharmacodynamic evaluation of ascending single intraarticular doses of~     GZ389988 in patients with painful OA of the knee.~   "
87257|NCT02424929|"~     The goal of this study is to compare the surgical outcome of deep brain stimulation (DBS)~     surgery in patients who are deeply sedated, asleep, or not sedated, awake, during~     surgical implantation of the DBS electrode. The investigators hypothesize that the clinical~     outcome, neurophysiological findings, and surgical accuracy will be equivalent. There are 3~     specific aims: 1) compare the activity of the neurons in the patients' brain in the asleep~     and awake groups using microelectrode recording, to see how this affects clinical outcome~     capability of microelectrode recordings and macrostimulation to identify the subthalamic~     nucleus in asleep patients. 2) Determine if intraoperative CT scans of the DBS electrode is~     sufficient for accurate DBS electrode placement. 3) Compare the clinical outcome on their~     Parkinson's disease between awake and asleep DBS patients.~   "
87258|NCT02424916|"~     This study evaluates the safety as well as the potential clinical efficacy of an adoptive~     transfer of CD8+ T cells, sorted with HLA-peptide multimers and specific for Melan-A and~     MELOE-1 melanoma antigens, to patients suffering from advanced metastatic melanoma (stages~     IIIc and IV).~   "
87259|NCT02424903|"~     The purpose of the study is to compare different approaches for the treatment of prosthetic~     joint revisions and to optimize the outcomes in patients with prosthetic joint infections~     (PJI) by improving the treatment concept of PJI.~   "
87260|NCT02424890|"~     The objective of this randomized trial is to study the effect of stress on performance and~     the effect of repetition of simulation sessions on performance and stress. This study is a~     randomized controlled trial including 48 participants who composed 12 multidisciplinary teams~     (MDTs). Each MDT was made up of 4 persons: an emergency physician, a resident, a nurse, and~     an ambulance driver who usually compose an emergency team of the French Emergency Medical~     Service (EMS). 6 MDTs underwent 9 simulation sessions over 1 year (Repetitive SIm Group). 6~     MDTs underwent 3 simulation sessions over 1 year (Control Group). Evidence of the existence~     of stress was assessed in 3 ways: salivary cortisol, Holter parameters, and psychological~     stress questionnaires. The impact of stress on overall team performance, on technical~     procedure, and on teamwork, is evaluated by specific validated scales. Detection of~     post-traumatic stress (PTSD) is performed by self-evaluation on the 7th day and after one~     month. The perspective is to concomitantly evaluate technical and non-technical performance,~     and the impact of stress on both. This is the first randomized trial studying repetition of~     simulation sessions and its impact on both clinical performance and stress as explored by~     objective and subjective assessments. The investigators expect that stress decreases team~     performance and that repeated simulation increases team performance. The investigators expect~     no variation of stress parameters regardless of level of performance.~   "
87261|NCT02424877|"~     The purpose of this study is to determine whether automated remote monitoring of patients~     with early rheumatoid arthritis by the SandRA software and short message service of cell~     phones increases patient compliance and helps to identify patients needing re-assessment of~     medication before scheduled visits. This might result in better clinical outcome and~     cost-effectiveness.~   "
87262|NCT02424864|"~     FDG PET-CT image acquisition in the abdominal and thoracic region is influenced by organ~     motion. Respiratory movement blurs the metabolic signal of the esophageal tumor and lymph~     nodes. The investigators hypothesize that the metabolic signal obtained with motion~     compensation results in higher SUV-max values and clearer demarcation of the esophageal tumor~     and lymph nodes.~   "
87263|NCT02424851|"~     The purpose of this study is to compare the effectiveness of bortezomib versus thalidomide in~     reducing free light chains in the blood of myeloma patients. In addition participants will~     receive bendamustine (chemotherapy) and dexamethasone (steroids), which increase the~     effectiveness of both bortezomib and thalidomide. The trial will also study whether an~     earlier reduction of free light chains increases the chances of the kidneys recovering.~   "
87264|NCT02424838|"~     After patients have been screened and have signed informed consent, they will be taken to the~     endoscopy suite. Once the decision has been made to proceed with Fine Needle Aspiration~     (FNA), the subject will be randomized to 1 of 4 groups:~        -  22 gauge (G) needle with suction~        -  25 G needle with suction~        -  22 G needle without suction~        -  25 G needle without suction~      Follow-up Phone Call Phase:~      Unit staff will call patients 1 week after the procedure to check if patients had any adverse~     events from the procedure and this will be recorded onto the dataset.~   "
87265|NCT02424825|"~     The purpose of this protocol is to collect data from approximately 15 multiple sclerosis (MS)~     patients who are participating in a pilot cooking course. This online cooking training~     program is currently available to general public through the company Rouxbe for a fee. Data~     gathered from this cooking course will be used to develop novel ways of promoting healthy~     eating habits in people with MS. The investigators will use the data from blood tests,~     questionnaires, and demographics to assess the feasibility and effectiveness of this program.~     This is an outpatient program designed for people with MS that would occur regardless of~     whether participant data is collected.~      This pilot cooking course will run for approximately four weeks. The investigators intend~     start to the training course in mid-March 2015. Subjects will be followed prior to course~     initiation for baseline data gathering, at four weeks from baseline, twelve weeks from~     baseline, and twenty-four weeks from baseline.~   "
87266|NCT02424812|"~     The effect of large scale handwashing and hygiene promotion campaigns on handwashing~     behaviour, diarrhoea and respiratory infections is not known. While Intensive small scale~     interventions have achieved improvements in handwashing behaviour and reductions in diarrhoea~     and respiratory infections, it is not clear whether realistic and scalable interventions~     delivered across large areas achieve effects large enough to be of public health interest.~     The Unilever School of 5 Lifebuoy campaign is such a scalable intervention that is being~     rolled out across the state of Bihar during 2015 to 2017. The proposed study aims at~     evaluation the effect of this campaign on handwashing behaviour in school aged children and~     their mothers, and on diarrhoea and respiratory infections in the same children and their~     younger siblings.~   "
87267|NCT02424799|"~     This First Time in Human (FTIH) study, which will be performed in three parts, is designed to~     investigate the safety, local tolerability, pharmacokinetics and pharmacodynamics after~     single and repeat topical applications of up to 2 strengths of GSK2646264 and corresponding~     placebo within the same subject, in healthy adult subjects (Part A), subjects with cold~     urticaria (CU, Part B) and subjects with chronic spontaneous urticaria (CsU, Part C). The~     study will also measure short term effects of GSK2646264 on the number and size of weals in~     subjects with CsU, and in healthy subjects and subjects with CU following provocation tests.~   "
87268|NCT02424786|"~     The study aims to investigate adherence and polypharmacy in elderly patients with chronic~     kidney disease (CKD) and End Stage Renal Disease (ESRD). The investigators look into possible~     factors or predictors that may affect adherence and reduce polypharmacy. Factors could be:~     quality of life, anxiety and depression, beliefs about medicine and cognitive impairment.~      The investigators are planning an intervention with the screening tool Screening Tool of~     Older Person's potentially inappropriate Prescription/Screening tool to Alert to Right~     Treatment (STOPP/START ) criteria to evaluate medication lists of the participating patients.~   "
87269|NCT02424773|"~     In immunocompromised patients, Acute Respiratory Failure (ARF) is associated with a high~     case-fatality, particularly when invasive Mechanical Ventilation (MV) is required. In the~     most hypoxemic patients, oxygen administration through High Flow Nasal Cannula (HFNC) has~     been reported as an alternative to the venturi mask. The aim of this study is to compare HFNC~     and venturi mask on early respiratory deterioration and patient's comfort in that setting.~     The investigators planned a prospective randomized study in 4 Intensive Care Units (ICUs). As~     respiratory deterioration occurs early after ICU admission, patients are randomized to~     receive two hours of oxygen therapy either through HFNC or venturi mask. The primary endpoint~     is defined as the need for invasive or noninvasive MV in the 2-hour period. Secondary~     endpoints include comfort, dyspnea and thirst.~   "
87270|NCT02424760|"~     The INSPYRE implant is a new range of shoulder hemi-arthroplasty device. It consists of a~     Pyrocarbon spherical interpositional implant and is indicated in primary surgery to relieve~     severe pain or significant disability caused by degenerative pathologies. The rotator cuff~     must be functional.~      The aim of this study is to prospectively collect data from consecutive series to implement a~     Post Marketing Surveillance plan.~   "
87271|NCT02424747|"~     The study evaluates how outcome varies among critically ill patients with and without acute~     kidney injury. Data from the Swedish Intensive care register and other Swedish national~     registers is used to compare how survival and post discharge renal function differ between~     critically ill patients with and without acute kidney injury.~   "
87272|NCT02424734|"~     The purpose of this study is to evaluate the safety and tolerability of ceftaroline for the~     treatment of Late Onset Sepsis in neonates and young infants aged 7 to <60 days~   "
87273|NCT02424721|"~     To validate the use of the Heparin Binding Protein (HBP) concentration to assist in the~     evaluation of patients admitting to the emergency department with suspected infection.~   "
87274|NCT02424708|"~     Glutathione is an important nutrient for brain function and loss of glutathione has been~     implicated in Parkinson's disease. Glutathione is an antioxidant made in the body out of~     three amino acids, the nutrients that make up protein. This study will determine whether~     administration of either dose of glutathione, as a nasal spray, improves PD symptoms over~     time in a population of individuals with Parkinson's disease (PD).~   "
87275|NCT02424695|"~     This is a phase IV single-blind, placebo run-in fixed dose single-group study to assess~     objective and subjective effects of GEn on sleep EEG, BP, and anterior tibialis EMG~     responsivity in patients with RLS. The study will include 8 visits over a period of up to 8~     weeks for eligible subjects including a 1 to 3-week Screening/Washout Period, a 1-week~     placebo run-in period, and a 4-week Treatment Period.The first placebo dose will be~     administered within 1 to 3 weeks after Screening/Washout. The total duration of the study~     from the first subject enrolled to the last subject completed will be approximately 1 year.~   "
87312|NCT02424201|"~     Postpartum haemorrhage is the leading cause of maternal haemorrhage globally. With active~     management of labour 3 to 16.5% of parturients still experience postpartum haemorrhage. Hence~     the need for an effective oxytocic in third stage of labour.~   "
87276|NCT02424682|"~     This study was designed to evaluate safety and tolerability of Herceptin as treatment for~     patients with human epidermal growth factor receptor 2 (HER-2) positive metastatic breast~     cancer. Frequency, characteristics and severity of adverse events (AE) and serious adverse~     events (SAE) were followed to evaluate the safety of Herceptin in patients with HER2 positive~     metastatic breast cancer.~   "
87277|NCT02424669|"~     Amyotrophic Lateral Sclerosis (ALS) is the most common motor neuron diseases. It is~     considered as a rare disease with a prevalence of about 8 per 100,000 persons. Initiating in~     mid-life by progressive paralysis, it evolves rapidly into a generalized muscle wasting that~     leads irrevocably to death within 2 or 5 years of clinical onset.~      Since there is no cure for ALS, the management of the disease is supportive and palliative.~     Riluzole is the only drug that has been shown to extend survival by about three months. The~     identification of biomarkers sensitive to the progression of the disease might enhance the~     diagnostic and provide new drug targets.~      Dysfunction of the immune system is a pathological hallmark of ALS. Increased levels of~     interferon gamma (IFNgamma) were found in the serum and cerebrospinal fluid (CSF) of ALS~     patients. However, the cell origin as well as the pathogenic influence of this peripheral~     source of IFNg is unknown. Thus, IFNgamma might have a role in the pathogenic process of ALS~     and might be a potential biomarker of the disease.~   "
87278|NCT02424656|"~     This study explores the changes in whole-brain connectivity that occur during recovery from~     severe Traumatic Brain Injury and how these changes are related to the recovery of~     consciousness. Multimodal neuroimaging techniques will be used in a longitudinal fashion~     while patients are undergoing neurorehabilitation and after one-year of the TBI episode.~   "
87279|NCT02424643|"~     The purpose of this study is to test the efficacy of alternative methods to improve survey~     completion.~   "
87280|NCT02424630|"~     The investigators compared the results of sono-guided interscalene brachial plexus block~     (ISB) combined with arthroscopy-guided suprascapular nerve block (SSNB) with those of ISB~     alone within the first 48 h after arthroscopic rotator cuff repair.~   "
87281|NCT02424617|"~     A Phase I/2 multi-center open-label study of BGB324 in combination with erlotinib in patients~     with Stage IIIb or Stage IV non-small cell lung cancer. BGB324 is a potent selective small~     molecule inhibitor of Axl, a surface membrane protein kinase receptor which is connected with~     poor prognosis and acquired resistance to therapy.~   "
87282|NCT02424604|"~     Aim The overall aim with this study is to improve outcome after inguinal hernia repair (IHR).~     It is not known today if a re-operation due to recurrence after bi-layer mesh IHR is more~     complicated than compared with the golden standard method.~      Method This project is a registry study. The National hernia register (Svenskt bråckregister,~     SBR) which started in 1992 include data that cover nearly 100% of all the country's hernia~     operations.~      Patient data are collected from SBR. Patients who at the time of surgery were between 18-75~     years of age and operated on due to primary inguinal hernia with any of the two mentioned~     techniques between 1992-2012 are eligible~   "
87283|NCT02424591|"~     Postoperative pain is severe after major spine surgery. Opioids such as morphine and~     hydromorphone are routinely used for postoperative pain control. These drugs have significant~     side effects, most importantly respiratory depression, nausea, constipation and tolerance.~     Moreover, many spine surgery patients have used opioid pain medication for back pain long~     term, leading to pre-surgical opioid tolerance and increased postoperative pain. This has led~     to a search for adjuvant medications to reduce the use of opioids and reduce opioid mediated~     side effects and tolerance.~      Ketamine is an intravenous anesthetic with analgesic properties in subanesthetic doses.~     Ketamine is a noncompetitive antagonist of N-methyl-D-aspartate (NMDA) receptors. NMDA~     receptors are involved in central pain sensitization via wind-up phenomenon and altered pain~     memory, a process which can be blocked by ketamine. NMDA receptor antagonists may prevent the~     development of tolerance to opioids and hyperalgesia. Ketamine has been safely used to~     decrease pain in numerous studies. Ketamine can also act as an antidepressant with hours of~     administration.~      Ketamine has rapid brain uptake and subsequent re-distribution with a distribution half-life~     of 10-15 minutes and an elimination half-life of 2 hours. Ketamine does not cause respiratory~     depression.~   "
87284|NCT02424578|"~     The purposes of this study are to evaluate the safety and tolerability and to model the~     single-dose pharmacokinetic profile of diclofenac capsules low dose and high dose in children~     ages 6 to <17 years experiencing mild to moderate acute postoperative pain.~   "
87285|NCT02424565|"~     The rationale of this study is to map out changes in temperature distribution brought about~     by topical application of our test product, and use this physiological phenomenon to~     visualize the onset of action involved in overall mechanism of action of the product.~   "
87286|NCT02424552|"~     The purpose of the EVITA trial is to compare the effects of vitamin D therapy with placebo on~     reducing the dose of inhaled or oral corticosteroids in patients with severe asthma and~     vitamin D insufficiency.~   "
87287|NCT02424539|"~     This Phase IV interventional study is a multi-center, randomized, double-blind,~     placebo-controlled parallel study to evaluate the efficacy and safety of FFNS110 mcg and 55~     mcg once daily versus vehicle placebo aqueous nasal spray in chinese pediatric subjects ages~     2 to 12 years with AR.~      This study comprises screening and run-in period (4 to14 days), double-blind treatment period~     (28 days) and follows up period (3 to7 days). Subjects entering the study will participate~     for maximum of 50 days, including five clinical visits and a follow-up contact.~      The study is planned to enroll approximately 360 subjects.~   "
87288|NCT02424526|"~     This study is designed to find the optimal dosage of home-based treadmill training needed to~     accelerate walking onset and to examine the long-term effects on the child's walking~     activity.~   "
87289|NCT02424513|"~     This is a prospective, multicenter, open-label, non-randomized study evaluating the ability~     of [89]Zr-Df-IAb2M to detect local, regional and metastatic prostate cancer confirmed by~     pathology.~   "
87290|NCT02424487|"~     The purpose of this study is to evaluate the initial pressure and changes of the intracuff~     pressure during one-lung ventilation (OLV) in infants and children during thoracic surgery.~   "
87291|NCT02424474|"~     The purpose of this study is to evaluate the performance of non invasive screening in a~     population of pregnant women with and without in vitro fertilisation (IVF) concomitantly to~     regular first trimester trisomy 21 (T21) screening using maternal age, nucal fold measurement~     and serum screening.~   "
87292|NCT02424461|"~     This study will investigate the treatment of urinary tract infection (UTI) in men. The~     investigators are looking to see if shorter duration of antibiotics (7 days) is not inferior~     to a longer duration of antibiotics (14 days). The investigators will also study whether~     longer treatment leads to an increase in antibiotic resistant bacteria in the gut microbiota~     or an increase in drug side effects.~   "
87293|NCT02424448|"~     This is a biopsy feasibility study in which patients with castration resistant prostate~     cancer (CRPC) will be asked to donate primary and metastatic tumour tissue (both archival and~     de novo), blood samples, a urine specimen and clinical data for research.~   "
87294|NCT02424435|"~     This study will explore whether methylprednisolone treatment is safe, well-tolerated, and~     beneficial in patients that are diagnosed with Friedreich Ataxia (FRDA). The study will also~     explore if methylprednisolone has any effects on biomarkers associated with FRDA. All~     subjects in the study will receive the same steroid treatment.~   "
87295|NCT02424422|"~     The aim of this study to test the immediate effect of rapid maxillary expansion on~     craniofacial sutures in children using cone beam computed tomography.~      Materials and Methods: Subjects consisted of 15 growing patients between the ages of 8 and 12~     with Skeletal transverse maxillary deficiency with unilateral or bilateral posterior cross~     bite.~      All patients will be treated with A bonded Hyrax (a rapid palatal expander with an acrylic~     occlusal splint). The planned activation protocol consisted of 2 turns per day (0.25 mm per~     turn) until the resolution of posterior cross bite with 2 to 3 mm overcorrection of expansion~     then tying off the jackscrew with a ligature wire and placing a smooth composite material~     over it. The initial CBCT scan (T0) will be taken before cementation of the maxillary~     expander and again immediately after the end of the active expansion (T1). First, all CBCT~     images will be oriented then the craniofacial sutures(Intermaxillary Suture, Midpalatal~     Suture, Transpalatal Suture, Internasal Suture, Frontonasal suture, Zygomaticotemporal~     suture, Frontomaxillary suture, Zygomaticomaxillary suture, Nasomaxillary sutures,~     Spheno-occipital synchondrosis) will be examined. Where the linear measurements will be~     carried out directly on the CBCT image using the OnDemand 3D Imaging software program.~   "
87296|NCT02424409|"~     For over ten years, the French group ASUR (ASthme aux URgences) has studied the asthmatic~     disease. The first epidemiological study enrolling 3.772 patients, in 37 emergency services,~     showed that the treatment protocols during the acute asthma attacks were not homogeneous and~     that oral corticosteroids were prescribed in only 50% of the cases. The second major French~     study in the emergency department by the same group enrolled 3.049 patients. The results~     showed that 38% of patients have a new acute asthma relapse in the month following their~     consultation in the emergency department. In the same study, a multivariate analysis of~     predictors of relapse showed that there are controllable factors (absence of written~     recommendations at discharge, only 50% of prescriptions for oral corticosteroids at discharge~     from the emergency department, limited follow-up by a general practitioner (GP) or~     pneumologist ...).~      The emergency physician has a responsibility in educating the patient during the period~     between an acute asthma attack and return to the stability of long term therapy. To date, the~     impact of patient education on the rate of further consultations in the emergency department~     has not been proven, although it seems to be a positive trend on its effect. In France, half~     of the patients coming to the emergency department for asthma attack will not be~     hospitalized. More than a third will return to the ED within the first 30 days for a new~     attack. The impact of post-interventional education on relapse should be explored. A first~     major study on a strict formalized protocol designed to reduce the relapse rate is essential~     and could allow a major improvement.~      Our main objective is to assess the impact of a strict formalized protocol of care of~     asthmatic patients discharged from the Emergency Department on the recurrence rate of asthma~     attacks, one month after an asthma attack.~      The expected benefit for the patient is the short-term reduction of relapse after asthma~     exacerbations, thus avoiding the problems of readmission. The strict formalized discharge~     protocol would also improve education in terms of self-medication in this gray zone of~     post-therapeutic monitoring. The benefit is even more important in terms of public health due~     to the important prevalence of asthma in the world and in our country. The advantage of this~     protocol is to strengthen the links between the hospital and the GPs. Education of asthmatic~     patients is essential in reducing morbidity. Thus, the potential benefits of this protocol~     are: reducing the cost of health and re-hospitalization, improved education of asthma~     patients, strengthening their link with the required GP, decreased absenteeism usually~     frequent in this type of disease in the workplace.~   "
87297|NCT02424396|"~     Interleukin‐2 (IL‐2) was initially discovered and used as a stimulator of effector T~     lymphocytes (Teffs), but is now viewed as a very promising immunoregulatory drug having the~     capacity to stimulate regulatory T cells (Tregs). At low dose, Il-2 tips the Treg/Teff~     balance towards Tregs. Recently, it has been shown that Tregs of MS patients have reduced~     proliferative potential. MS-IL2 will assess the safety and biological efficacy of low-dose~     IL2 as a Treg inducer in a Relapsing-Remitting Multiple Sclerosis (RRMS), with the aim to~     stimulate Treg and define potential clinical benefits~   "
87298|NCT02424383|"~     The objective of this patient registry is to assess the clinical use of the Lutonix 035 DCB~     PTA Catheter in a heterogeneous patient population in a real world and on-label clinical~     application.~   "
87299|NCT02424370|"~     Transcutaneous trans-aortic valve replacement (TAVR) is now a common procedure to treat~     symptomatic aortic stenosis. Although as effective and safe as surgical aortic valve~     replacement, it is still restricted to high surgical risk patient who are frail. The aim of~     the TAVI-EVA is to identify geriatric biomarkers that may help to predict survival and~     functional recovery after TAVR~   "
87300|NCT02424357|"~     1. To establish the culture positivity rate in adjustable suture strabismus surgery~        2. To identify bacterial species and antibiotic susceptibility patterns of microorganisms~          cultured from suture material~        3. To compare suture contamination rates with techniques to reduce the suture contamination~          rate~   "
87301|NCT02424344|"~     The present study is planned to evaluate the effect of the aclidinium bromide/formoterol~     fumarate 400/12 μg FDC BID on the hyperinflation, exercise endurance and physical activity in~     patients with moderate to severe COPD. Additionally, the effect of the behavioural~     intervention on top of aclidinium bromide/formoterol fumarate 400/12 μg will be assessed both~     on the exercise endurance and the physical activity.~   "
87313|NCT02424188|"~     This study will determine whether an 18-month practical tobacco smoking cessation program~     integrating weight management counseling and exercise will be superior to treatment as usual~     in achieving prolonged smoking abstinence in persons with serious mental illness.~   "
87314|NCT02424175|"~     This is an open-label single-arm pilot study to measure the microbiological and clinical~     impacts of Fecal Microbiota Transplantation (FMT) in patients with Primary Sclerosing~     Cholangitis (PSC). The investigators will prospectively enroll 10 PSC patients Stage 1 and 2~     who also have concurrent inflammatory bowel disease Donor Stool from one healthy donor will~     be obtained from OpenBiome. OpenBiome is a nonprofit 501(c)(3) organization that provides~     hospitals with screened, filtered, and frozen material ready for clinical use~   "
87373|NCT02423408|"~     This is a randomized, multicenter, double-blind, placebo-controlled, parallel-group study to~     evaluate the safety and efficacy of a single dose of TNX-201 (140 mg) for the treatment of a~     single qualifying Tension-Type-Headache (TTH).~   "
87302|NCT02424331|"~     This study aimed to evaluate the acute effect of PLB technique on diaphragmatic mobility, the~     kinematics of the thoracoabdominal complex analysis of lung volumes and exercise tolerance in~     patients with Chronic Obstructive Pulmonary Disease (COPD). This is a study randomized~     cross-over clinical trial and blind, in subjects with Chronic Obstructive Pulmonary Disease~     (COPD) according to criteria of the Global Initiative for Chronic Obstructive Lung Disease~     (GOLD) (FEV1 / FVC <0.7 and FEV1 <80% predicted) selected at the Clinical Hospital of the~     Federal University of Pernambuco (UFPE) and Otavio de Freitas General Hospital (HGOF). The~     investigators recruited 13 patients COPD (according to previous sample calculation) aged~     between 40 and 80 years, of both sexes. The first day was held evaluation of lung function,~     respiratory muscle strength, body composition, dyspnea index and functional capacity. On the~     second day was held evaluation of thoracoabdominal complex kinematics by plethysmography~     Optoelectronics (OEP) with Quiet Breathing (QB) or pursed-lips breathing (PLB). Lung volumes~     with 2 minutes with QB and 6 minutes PLB or only 6 minutes by QB as randomization were~     observed. Before and after performing the requested breathing pattern diaphragmatic mobility~     was observed by Ultrasonography (US) and requested the patient an Inspiratory Capacity~     maneuver (IC). The evaluator who performed the ultrasound was blinded as to the beginning of~     the breathing pattern of order performed by the patient.~   "
87303|NCT02424318|"~     The purpose of this study is to evaluate the effect of topiramate on cerebrovascular~     reactivity and mean flow velocity to photic stimulation in migraineurs.~   "
87304|NCT02424305|"~     This is an open-label, uncontrolled, non-randomised multi-centre trial in which 3 parallel~     groups will be enrolled. The trial includes three active treatment groups. To be eligible for~     inclusion in this trial, subjects must have at least 15 clinically typical, visible, and~     discrete actinic keratosis (AKs) on the face, scalp or on the arm within a contiguous area of~     approximately 250 cm2 of sun-damaged skin.~      There will be 3 treatment groups: (1) once daily application of LEO43204 gel 0.018% on the~     full face for three consecutive days, (2) once daily application of LEO43204 gel 0.1% on the~     arm on a treatment area of approximately 250 cm2 for three consecutive days and , (3) once~     daily application of LEO43204 gel 0.037 % on the scalp for three consecutive days.~   "
87305|NCT02424292|"~     Patients diagnosed with breast cancer generally have a fairly well prognosis with estimated~     average survival rates of 73% and five year survival rates of 89% in developed countries.~     However, women who are obese at the time of breast cancer diagnosis seem to be at risk for a~     worse breast cancer related and overall survival, as compared to their normal weight~     counterparts. In addition, weight gain after diagnosis might be negatively associated with~     prognosis.~      Weight gain is a common phenomenon among breast cancer patients receiving adjuvant~     chemotherapy as well as receiving adjuvant anti-hormonal therapy. While sufficient physical~     activity and limitation of the amount of weight gain is important for all breast cancer~     patients, it surely is for overweight and obese patients. The recently published national~     guideline oncological rehabilitation provides exercise goals, for physical training based on~     the Dutch PA guideline Nederlandse Norm Gezond Bewegen (NNGB). It recommends to engage in~     moderate-intensity exercise (e.g. brisk walking) for at least 30 minutes a day, on at least 5~     days a week. For people who are overweight (Body Mass Index ≥ 25 kg/m2) it is recommended to~     exercise at least 60 minutes at a moderate-intensity level, equal or more than 3 Metabolic~     Equivalent Task Hours (> 3 MET/h), on at least 5 days a week. However, only 61% of the~     general population, meets these guidelines (8) and among cancer patients this percentage is~     even less. This study aims to increase the percentage of overweight breast cancer patients~     treated with adjuvant anti-hormonal therapy that reaches the goal of the NNGB by the~     oncological rehabilitation program with 20%.~   "
87306|NCT02424279|"~     Pancreatic cancer is a difficult to treat disease, mainly due to the fact that diagnosis is~     made usually in the late stage of this condition. One of the treatment methods of pain~     accompanying this neoplasm is thoracoscopic splanchnicectomy. It has been shown that it is a~     safe procedure with a small percentage of complications, nevertheless it is often use as the~     last stage in pain management what significantly decreases its effectiveness.~      The aim of this study is to determinate the effect of invasive pain treatment~     (splanchnicectomy) in patients with advanced pancreatic cancer on subjective pain perception~     at rest, in movement and after meals (measured with the BPI, QLQ- C30 and FACIT~     questionnaires), and suffering (measured with PRISM projection test), the use of painkillers~     during the disease and patients' overall survival. Moreover the investigators want to check~     if early performance of splanchnicectomy (on lower steps of analgesic ladder WHO) is combined~     with better therapeutic effect of this treatment.~   "
87307|NCT02424266|"~     The purpose of this study is to investigate the ability of an imaging device, developed by~     AdOM Advanced Optical Technologies Ltd. (AdOM). The device allows a three-dimensional~     imaging of the ocular tissues, specifically the tear film layers and the retinal layers. The~     device is based on the use of white light.~      In this initial study, the device will be used to assess the tear film which coats the~     corneal surface in healthy subjects as well as in moderate-to-severe Keratoconjunctivitis~     Sicca (KCS) or Dry Eye Syndrome (DES). The ability of the device to assess the retinal layers~     will be evaluated in the second phase of the study.~   "
87308|NCT02424253|"~     This will be a randomized, double blind, placebo controlled, parallel group study in~     approximately 90 subjects with moderate-severe AD Eczema Area and Severity Index (EASI) ≥12~     and ≤ 48 (0-72 scale). Following a run-in subjects will be randomized to receive either oral~     30 mg ZPL-3893787 once daily (od) or placebo od for 8 weeks (56 days).~   "
87309|NCT02424240|"~     A 35-month cross-sectional observational study was conducted at an outpatient university~     hospital in Amman, Jordan. We obtained a comprehensive medical and laboratory evaluation for~     134 short-statured children (64 boys and 70 girls, aged 4-16 years). Complete and partial~     growth hormone deficincy (GHD) were defined as peak forwth hormone (GH) response of 5 and 7~     ng/ml [IRMA/ DiaSorin®], respectively in both clonidine stimulation and insulin tolerance~     tests. Serum IGF-I, IGFBP-3 and IGF-I/IGFBP-3 ratio were determined for all participants.~   "
87310|NCT02424227|"~     This is a prospective, multicenter, observational study of kidney transplant subjects where~     blood specimens, intended for dd-cfDNA and other future research purposes, will be drawn~     after transplant~   "
87311|NCT02424214|"~     Comparing the efficacy of tow factors for artificial Oocyte Activation for poor quality~     Oocytes and Teratozoospermia patients.~   "
87315|NCT02424162|"~     This study will compare cataract patients with implantation of diffractive multifocal IOL~     with an additional power of +2.75 diopters (Group 1) and with +3.25 diopters (Group 2).~     Evaluations will be performed 1 and 3 months following cataract surgery, including~     measurement of uncorrected distance visual acuity (UDVA), refractive error (manifest~     refraction [MR]), and uncorrected near visual acuity (UNVA) at 33, 40, and 50 cm. At 3~     months, internal aberrations and contrast sensitivity will be evaluated and subjects will~     complete a questionnaire on outcomes satisfaction, visual symptoms, and spectacle use.~   "
87316|NCT02424149|"~     In this prospective, randomized trial subjects will be randomized to receive phenazopyridine~     or no medication prior to pelvic reconstructive procedures that use cystoscopy to confirm~     ureteral patency intraoperatively.~   "
87317|NCT02424136|"~     Peanut allergy can be life-threatening. Current diagnostic techniques for peanut allergy have~     high sensitivity, but not high specificity. This clinical trial will test the validity of a~     novel blood biomarker (compared with current testing) as a diagnostic predictor of~     anaphylaxis to peanut.~   "
87318|NCT02424123|"~     Seizures represent an important clinical problem, accounting for at least 40% of adult onset~     epilepsy. Predicting seizure recurrence in subjects experiencing a first seizure is difficult~     due to the lack of prognostic biomarkers. Recent evidence has indicated that blood-brain~     barrier (BBB) dysfunction constitutes an etiological factor to seizures. In particular, it~     has been shown that modification of BBB permeability is associated with seizure activity. In~     addition, it was demonstrated that BBB permeability can be assessed by measuring serum level~     of the protein S100B. Based on these data and considerations the investigators will test~     whether the extent of BBB damage at time of first seizure is predictive for seizure~     recurrence.~      The main objective of this study is to evaluate the association between the absolute (ng/ml)~     serum S100B levels (measured at time of the first seizure) and the experience, or not, of~     seizure recurrence within one year of follow-up.~   "
87319|NCT02424110|"~     The objective of the study is to make up the technique blind spots of the bipolar~     radiofrequency ablation in the surgical treatment of atrial fibrillation with rheumatic heart~     disease by using argon beam coagulator. And to improve the rates of cardioversion of atrial~     fibrillation after surgery, to decrease the long-term recurrence rate of atrial fibrillation~     and to compare the early term and long term outcomes of bipolar radiofrequency ablation and~     bipolar radiofrequency plus argon beam coagulator ablation.~   "
87320|NCT02424097|"~     The objective of this clinical study is to evaluate the efficacy of multiple applications of~     MI Varnish in combination with MI Paste Plus in caries protection and remineralization in~     comparison to the use of a control (Crest 1,100ppm Fluoride tooth paste, Fluoride rinse~     recommendation) in orthodontic patients in a randomized, single blind, prospective,~     controlled clinical trial over 12 months.~      The effect will be measured by white spot lesion regression and prevention as lesion count.~     Lesions will be scored using the Enamel Decalcification Index (EDI) area evaluation scheme~     (primary outcome), International Caries Detection and Assessment System (ICDAS), the caries~     lesion activity criteria (Nyvad criteria; Bente Nyvad, Scandinavian Researcher), and~     Quantitative Light Fluorescence (QLF, Inspektor Pro, Netherlands)/SOPROLIFE (SOPROLIFE~     fluorescence camera system, Acteon, France) evaluation in maxillary and mandibular anterior~     teeth with orthodontic brackets in treatment and control groups.~   "
87321|NCT02424084|"~     In trauma surgery and hand surgery treatment strategies of none healing bone fractures aim at~     replacing pseudarthrosis by well vascularized bone and improving microcirculation. Although~     previous studies indicate that extracorporeal shock wave therapy (ESWT) can accelerate bone~     healing in case of non-union, only a few studies focused on the elucidation of its mechanisms~     of action. Therefore, the aim of this study is to evaluate the microcirculatory effects of~     extracorporeal shock wave therapy on scaphoid bones and metacarpal and metatarsal in a human~     in-vivo setting for the first time.~   "
87322|NCT02424071|"~     Melatonin has sedative, hypnotic and analgesic properties that make it a good premedication~     agent before anesthesia and surgery.~      In this study the investigators intend to randomise 60 patients undergoing bariatric surgery~     into two groups. The participants will receive either melatonin or placebo on the evening~     prior to the surgery, and the same agent two hours before the surgery.~      The patients recovery from the surgery and anesthesia will be assessed using the Q0R15~     questionnaire. The patients will be asked to take the questionnaire once in the pre-operative~     clinic, again after the second melatonin or placebo pill before entering the operating room,~     and once more on the first post-operative day.~   "
87323|NCT02424058|"~     The purpose of this study is to investigate the sagittal thoracic spinal curvature and~     mobility in subjects with and without chronic neck pain, cut-off points and pain relationship~   "
87324|NCT02424045|"~     BCD (Bendamustine, carboplatin and dexamethasone)chemotherapy regimen is proposed as the~     salvage treatment for relapsed or refractory PTCLs in this study protocol, which would be~     expected to show more promising clinical outcomes than that of bendamustine single therapy.~     Platinum combination with bendamustine is a theoretically ideal salvage regimen for the~     patients of PTCLs because these both agents are highly effective drugs in lymphoma treatment~     and have rare cross-resistance. Carboplatin was selected as a platinum agent for combination~     with bendamustine, which is a second generation platinum agent and has a less neurotoxicity~     than that of cisplatin, considering use for previously treated patients with vinc alkaloid~     agents.~      In a prior phase I study of carboplatin in combination with bendamustine for previously~     untreated small cell lung cancer patients, the recommended dose for phase II studies was~     bendamustine 100 mg/m2 on day 1 and 2, carboplatin AUC 5 on day 1, respectively [16]. In~     consideration of previously treated subjects, however, the dose of bendamustine was decided~     on 80mg/m2 in this study protocol with concerning about the toxicities, especially to severe~     cytopenia.~      Dexamethasone is one of the corticosteroids using a key drug for lymphoid malignancy and has~     a strong antiemetic effect. Therefore, dexamethasone could enhance the therapeutic efficacy~     and antiemetic effect, using with bendamustine and carboplatin.~   "
87325|NCT02424032|"~     The aim of this study was to investigate and compared the effects of cervical and~     scapulothoracic stabilization exercises with and without connective tissue massage (CTM) for~     patients with chronic mechanical neck pain.~   "
87326|NCT02424019|"~     This study will assess the safety in patients treated with ILUVIEN, with primary focus on~     IOP.~   "
87327|NCT02424006|"~     In this study safety and effectiveness of bioengineered cornea comprising of interpenetrating~     networks of recombinant human type III collagen and synthetic phospholipid -~     phosphorylcholine - will be tested in patients with corneal scars (leukomas) after infection,~     trauma or keratoconus. Control group will consist of patients with the same condition who~     will undergo corneal transplantation - current standard of care.~   "
87328|NCT02423993|"~     The purpose of this study is to assess the effectiveness of structured group education on~     glycemic control and Quality of Life (QoL) among users of continuous subcutaneous insulin~     infusions (CSII).~   "
87329|NCT02423980|"~     This is an open-label, exploratory pilot study in patients with T1D. The study will involve~     two daytime clinical research center visits 7-14 days apart. Subjects will receive a single~     injection of G-Pen™ (glucagon injection) at each visit.~   "
87330|NCT02423967|"~     The primary goal of this study will be to assess whether stool collected and frozen from~     anonymous screened unrelated donors can be as effective as stool freshly collected from~     recipient's parents when used in Fecal Microbial Transplant for the eradication of recurrent~     Clostridium difficile infections in children. In the current protocols, which are more than~     90% effective, each child who is receiving a fecal transplant has to provide their own donor~     stool, usually from a parent or close relative. This requires considerable screening costs~     for each case and is logistically complicated as the donor must be present and must stool~     just prior to the transplant. The investigators hope to show that a small number of healthy~     donors can provide stool samples which can be frozen and banked and then thawed for use in~     numerous patients. The primary goal is to show that Clostridium difficile will be eradicated~     as effectively (Greater than 90% success) when using the stool from the frozen donors.~      The study will also evaluate the inflammatory response and intestinal microbiome in young~     children aged 1-3 years with Clostridium difficile infections to better predict which ones~     will respond to fecal transplantation and which ones have incidental infections. For this~     question the investigators will gather stool samples to check for lactoferrin, calprotectin,~     and alpha1antitrypsin, and 16s ribosomal RNA analysis in children before and after the fecal~     transplants. The goal is to see if there is an intestinal microbiome that predisposes some~     children to getting sick from Clostridium difficile versus just having it incidentally.~   "
87331|NCT02423954|"~     Determine the recommended phase 2 dose (RP2D) of chemotherapy in combination with nivolumab~     in subjects with advanced cancer.~   "
87332|NCT02423941|"~     To evaluate whether retrograde caval reperfusion of liver graft could be superior over~     antegrade portal reperfusion in regard of incidence and severity of early allograft liver~     dysfunction.~      All eligible enrolled liver transplant candidates will be randomized to receive either:~        1. retrograde caval, followed by sequential portal-arterial, reperfusion or~        2. antegrade, sequential portal-arterial reperfusion.~   "
87333|NCT02423928|"~     20 patients with invasive castration resistant prostate cancer and radiologically verified~     metastases will be enrolled into the Phase I Clinical Trial. The trial is a dendritic cell~     based immunotherapy. Autologous dendritic cells will be obtained by leukapheresis and~     elutriation and stimulation by cytokines. The induced dendritic cells will have to pass~     viability, immunophenotyping and sterility criteria and will be injected into a cryoablated~     region of the primary prostate cancer tumor. The treatment is supplemented by~     immunomodulatory regimens.~   "
87334|NCT02423915|"~     Any time the words you, your, I, or me appear, it is meant to apply to the potential~     participant.~      T-cells are white blood cells that are important to the immune system. The T cells for this~     study (called regulatory T-cells, or Tregs) will be from a donor who is not related to you.~     Before the Tregs are given to you, they may be changed in the laboratory to make use of sugar~     that is found in small amounts in blood cells through a process called fucosylation. They are~     then called fucosylated Tregs. Adding more sugars to the Tregs in the laboratory is designed~     to help the Tregs find their way faster to the bone marrow, which may help low blood counts~     to recover faster.~      The goal of this clinical research study is to learn if it is safe and practical to give~     fucosylated Tregs to patients who will receive a matched related donor (MRD), a matched~     unrelated donor (MUD), or cord blood transplant. Researchers also want to learn if these~     Tregs may prevent or reduce the effects of graft-versus host disease (GVHD). GVHD can result~     from a reaction of the transplanted cord blood cells against certain tissues in the body.~      This is an investigational study. Fucosylation of Tregs is not an FDA-approved process. It is~     currently being used for research purposes only. Fludarabine, melphalan, cyclophosphamide and~     rituximab are FDA approved and commercially available to be given to patients with leukemia~     or lymphoma having a cord blood transplant. Total body irradiation is delivered using~     FDA-approved and commercially available methods.~      Up to 47 patients will take part in this study. All will be enrolled at MD Anderson.~   "
87335|NCT02423902|"~     This is a single-arm, phase Ib/II study to examine the safety, tolerability and preliminary~     efficacy of one cycle of Ad-RTS-hIL-12 immunotherapy in women with advanced breast cancer and~     pre-study SD or PR after completion of a minimum 12 week course of standard first- or~     second-line chemotherapy. The patient population will include patients with locally advanced~     or metastatic breast cancer of all subtypes.~   "
87336|NCT02423889|"~     This is a prospective, single arm, phase II, multicentric study. It evaluates the acute and~     late toxicity after stereotactic radiotherapy in low risk prostate cancer patients. All~     participants receive a total dose of 36.25 Gy in 5 fractions, twice a week, 7.25 Gy per~     fraction.~   "
87337|NCT02423876|"~     This randomized clinical trial studies epidural anesthesia within an enhanced recovery~     pathway (ERP) in reducing pain in patients undergoing gynecologic surgery. An epidural~     analgesia (pain relief) is a small tube placed in the lower back that numbs the nerves and~     stops the feeling of pain. It stays in place for several days after surgery and may be~     helpful for pain control in patients with gynecologic cancer after surgery. ERP is a set of~     specific steps used before, during, and after surgery by health care providers to care for~     patients after surgery. ERPs include patient education, not using laxatives before surgery,~     increasing activity after surgery, and scheduled use of medications for pain and nausea.~     Giving epidural anesthesia as part of an ERP may improve pain control in patients undergoing~     gynecologic surgery.~   "
87339|NCT02423850|"~     Diabetic foot ulcers and venous leg ulcers constitute an increasing health problem in Denmark~     concurrent with an ageing population and an increase in diabetes prevalence. Diabetic foot~     ulcers belong to the most serious and costly complications. Several studies have found that~     the size and depth of the ulcer is one of the major etiologic factors for delayed healing.~     Wound measurement is important in the monitoring of the wound healing process. For the last~     decade different 3D techniques for measuring ulcers have been proposed in order to measure~     ulcer volume, but none of the technologies have been widely used. A 3D photo-optical camera~     has been developed, which is able to measure ulcer area and volume.~      The investigators hypothesize that volumetric measurements of diabetic foot ulcers and venous~     leg ulcers are feasible in the assessment of ulcer healing. A prospective cohort study is~     conducted in which newly admitted patients with a diabetic foot ulcer or venous leg ulcer are~     included at the first visit at the polyclinic. The patients are followed for one year or~     until complete ulcer healing, amputation or death. Ulcer area and volume are measured by the~     3D camera with frequent intervals. Patient anthropometrics and ulcer data are collected~     during the study and correlated to the ulcer healing.~   "
87340|NCT02423837|"~     -  To evaluate the efficacy of bendamustine in combination with rituximab as first line in~          patients with follicular lymphoma, 1-3A cytological type.~        -  To evaluate the safety, tolerability and feasibility of bendamustine in combination with~          rituximab as 1st line in patients with follicular lymphoma, 1-3A cytological type.~        -  To evaluate the impact of the regimen modification (bendamustine dose modification~          and/or extension of inter-cycle interval) into duration of complete and partial~          responses.~        -  To evaluate estimated treatment duration, reasons of treatment withdrawal.~        -  To evaluate the possibility of unification and standardization of therapy protocol BR~          (rituximab 375 mg/m2 on day 1 and bendamustine 90 mg/m2 on days 1-2).~        -  To evaluate factors affecting overall and progression-free survival.~   "
87341|NCT02423824|"~     Cognitive deficits are a core feature across disparate brain disorders, being highly~     prevalent and pervasive. Impairments in executive function are one of the most consistent~     findings in clinical and meta-analytical studies and were reported to be a principal mediator~     of psychosocial impairment and disability. Cognitive dysfunction is thought to be underlied~     by abnormalities in distributed brain circuits, at the cellular and molecular levels.~     Nonetheless, the neural mechanisms underlying the dysregulation in these circuits are poorly~     understood. Emerging evidence indicates that metabolic abnormalities are highly relevant for~     the domain of cognitive function and indicate that alterations in metabolic pathways may be~     relevant to neurocognitive decline across different populations. The incretin glucagon-like~     peptide-1 (GLP-1) is a hormone secreted by intestinal epithelial cells. GLP-1 receptors are~     widely expressed in the central nervous systems. Pre-clinical trials have demonstrated~     significant neuroprotective effects of GLP-1. Ongoing clinical trials measuring cognition and~     mood in populations with various psychiatric disorders lend further impetus to explore the~     effects of GLP-1R agonists on brain structure and cognitive function. We hypothesize that~     GLP-1 and the GLP-1R are relevant for molecular and cellular processes that are thought to~     underlie the formation and maintenance of brain circuits. A derivative of this hypothesis is~     that the administration of GLP-1 agonists may result in enhanced neuronal survival and~     consequential increase in gray matter volume. We therefore propose to explore the cellular~     and molecular abnormalities within and between neural circuits subserving cognition using the~     GLP-1R agonist liraglutide.~      The overall goal of this study is to explore the relationship between a metabolic molecular~     target (i.e. the GLP1 system), the neural circuits of interest and the behavioral phenotype~     cognitive function.~   "
87342|NCT02423811|"~     Esophageal cancer is a common and fatal malignancy. It is the eighth most common incident~     cancer and the sixth leading cause of cancer death in the world. In Taiwan, esophageal cancer~     was newly diagnosed in 2199 patients and was the cause of 1507 deaths in 2011. Squamous cell~     carcinoma is the predominant histological tumor type, accounting for about 90% of the cases.~     Esophageal squamous cell carcinoma (ESCC) is an aggressive disease, characterized with~     extensive local growth and frequent metastases. Concurrent chemoradiotherapy (CCRT) with or~     without surgery is the treatment option for locally advanced ESCC. Further, target therapy is~     used in conjunction with CCRT and surgery in ESCC since several years ago. However, the~     therapeutic outcomes are not satisfactory due to the emergence of chemo-radioresistance. It~     is imperative to investigate new biomarkers and to find novel treatment targets in ESCC.~      A small population of tumor-initiating cells or cancer stem cells (CSCs) possess some~     biological functions like normal stem cells, including self-renewal, asymmetric cell~     division, slowly proliferation rate and drug-resistance. CSCs from many primary tumors and~     cell lines express specific stem cell markers, including Oct4, Sox2, Nanog, CD133~     (promimin-1), Nestin, CD44 ,CD24, ALDH (Aldehyde dehydrogenase) and c-Kit. There are many~     evidences that CSCs are responsible for tumor initiation, progression and metastasis. CSCs~     are also believed to have important roles in cancer recurrence due to their resistance to~     anti-cancer drugs and radiation. CSCs express high levels of ATP-binding cassette (ABC)~     transporters. ABC transporter can pump cytotoxic drugs out of cells and is one important~     mechanism of multidrug resistance in CSCs. In addition, CSCs have high reactive oxygen~     species (ROS) scavenger expression to remove ROS produced from irradiation therapy.~      Fursultiamine (also known as thiamine tetrahydrofurfuryl disulfide, TTFD) is a derivative of~     vitamin B and currently used for nutrition supplement. The investigators have identified that~     Fursultiamine suppressed OCT-4, SOX-2, NANOG expression and decreased ABCB1 and ABCG2 in~     tumor sphere of ESCC cell lines. In this project, the investigators will conduct a~     prospective phase II study to investigate the effect of Fursultiamine combined with CCRT in~     ESCC patients. Stem cell markers in clinical specimens collected before and after CCRT will~     be evaluated.~   "
87343|NCT02423798|"~     The trial will investigate the accuracy and performance of a new sensor for continuous~     glucose monitoring (CGM), the (new generation) Enlite, CE-marked in 2013, in conjunction with~     the new Medtronic 640G system components.~      To evaluate the accuracy and performance of the new generation Enlite sensor. This is a~     postmarket, interventional, open-label, non-randomized, single center clinical research~     trial.~      The trial will adopt a prospective single-sample design using the Yellow Spring Instruments~     (YSI) plasma glucose reference sampling procedure in the clinic and self-monitoring of blood~     glucose (SMBG) plasma glucose reference sampling procedure at home.~   "
87344|NCT02423785|"~     In colorectal cancer therapy anti-angiogenic strategies have become a cornerstone of~     treatment regimens in the metastatic setting. Addition of bevacizumab to conventional~     chemotherapeutic combination regimens has improved the median overall survival of advanced~     colorectal cancer patients by approximately 5 months. Selecting patients, who will benefit~     from anti-angiogenic approaches, would be highly desirable in order to optimize treatment~     strategies. Changes in ocular blood flow may be an attractive biomarker for predicting~     treatment response. In light of the given alternative first line treatment options such a~     predictive biomarker would be of clinical benefit. In the proposed study the investigators~     will assess potential changes in the ocular blood flow of mCRC patients after treatment with~     standard of care anti-angiogenic/cytotoxic therapy as an early predictive marker of treatment~     response as assessed by standard CT-scan~   "
87345|NCT02423772|"~     Chronic pain and misuse of opioids is a major public health problem, particularly in military~     veterans. The major goal of this project is to test the efficacy of an innovative behavioral~     treatment for chronic pain patients who are misusing prescription opiates. This project~     supports the strategic goals of National Center for Complementary and Integrative Health~     (NCCIH) and National Institute on Drug Abuse by examining a difficult and understudied~     problem with the ultimate goal of impacting scientific knowledge and human health.~   "
87347|NCT02423746|"~     Purpose:~      This study is a feasibility trial of an existing evidence-based behavioral parent training~     program with parents of preschool-aged children who were born deaf or hard of hearing (DHH).~      The hypotheses of this study are (a) that a randomized control trial of the Family Check Up~     with this population will be feasible, (b) parents will rate the intervention as acceptable,~     and (c) a signal of effect will be observable among intervention group parents compared to~     controls for the following outcome variables: child behaviors, parenting behaviors, and~     parenting sense of competence.~   "
87348|NCT02423733|"~     Depression is common and disabling but access to specialist treatment is often delayed with~     waiting lists of up to a year not uncommon. Also treatment is frequently limited to drug~     therapies because of long waiting lists to see psychological therapists face to face despite~     recommendations by NICE (The National Institute for Health and Clinical Excellence) and~     others about the importance of non-drug therapies. One way to address this problem is to use~     computerized e-therapies which deliver structured cognitive behavioral treatment where the~     therapy can be accessed in a location and at a time that is convenient for patients and where~     there is no waiting list. Previous randomized controlled trials of e-therapies for depression~     have mainly been in people recruited through the internet or in clinical populations with~     mild disorders where many participants do not complete the on-line course. Despite this there~     is some evidence that clinician-assisted computerized cognitive behavior therapy can result~     in significant improvements in depression with reduced demands on clinician time. To date~     there have been no trials of clinician assisted e-therapy in secondary care.~      Therefore the aim of this clinical trial is to answer the question In patients on the~     waiting list for the mood program does a computerized therapy with an e-therapy coach~     compared to written information about depression and the availability of computerized~     treatments result in better outcomes, quicker improvements and the use of fewer resources~     after 12 weeks. The study will be a randomized controlled trial with health service use and~     PHQ-9 as the main outcome measures.~   "
87349|NCT02423720|"~     This is a audio based mindfulness meditation intervention for colorectal cancer patients and~     caregivers. A 8-week single arm study will be conducted among University of California, San~     Francisco (UCSF) patients with metastatic colorectal cancer undergoing chemotherapy and~     caregivers of these patients (44 participants total).~   "
87350|NCT02423707|"~     Allergen-specific immunotherapy (ASIT) is commonly used to treat patients with allergic~     rhino-conjunctivitis and asthma, and it is the only proven treatment that affects the~     long-term development of allergic rhinitis and asthma. The current treatment regime of ASIT~     requires numerous subcutaneous allergen injections and takes several years to complete.~     Hence, there is a need to develop more convenient protocols for induction of allergen~     tolerance.~      Emerging evidence suggest that by targeting of antigen presenting cells within the lymph~     nodes the immunogenicity of the allergen can be enhanced and the number of injections can be~     reduced.~      The purpose of this study is to evaluate whether intralymphatic administration of ASIT is a~     safe and effective treatment for patients with pollen-induced allergic rhinitis. The long~     term goal is to provide a base for a more efficient administration of ASIT, which will reduce~     both the dose necessary and the number of clinic visits associated with the conventional~     subcutaneous ASIT.~      The investigators will make an attempt to reproduce the results of a recent human study of~     intralymphatic ASIT (clinicaltrials.gov; NCT00470457) in a Swedish clinical setting.~      The first part of the study is completed and published (PMID: 23374268)~   "
87351|NCT02423694|"~     Main objective: to compare the effects of electro-acupuncture and escitalopram oxalate~     tablets on mild-to-moderate perimenopausal depression, and to evaluate the safety of~     electroacupuncture stimulation.~   "
87352|NCT02423681|"~     To compare a group of patients with our standard treatment of continuous positive airway~     pressure (CPAP) and another group of patients with CPAP and a humidifier attached. The~     therapy cost and the successfulness of the treatment will be measured. A humidifier is a~     water chamber that is currently added to CPAP only if the patients needs it.~   "
87353|NCT02423668|"~     To study the effective lens position concept in second eye refinement (SER) cataract surgery,~     by relating inter-ocular symmetry of pseudophakic anterior chamber depth (pACD) measured in~     Pentacam and SER refractive outcomes.~   "
87354|NCT02423655|"~     This study evaluates the efficacy and safety of deferred dialysis initiation in Chinese~     population. 16 tertiary hospitals across China will be randomly assigned into routine and~     deferred dialysis groups.~   "
87355|NCT02423642|"~     The purpose of this study is to study the effect of anticoagulation in immune response with~     Acute Kidney Injury (AKI) undergoing Continuous Renal Replacement Therapy (CRRT).~   "
87356|NCT02423629|"~     Evaluate the performance of the Agili-C™ in the repair of Cartilage and Osteochondral~     defects.~   "
87357|NCT02423616|"~     This study aimed to examine the possible relationship between hand grip strength (HGS) and~     maximum inspiratory pressure (MIP) in healthy individuals.~   "
87358|NCT02423603|"~     Normally, cells in human body divide in an orderly way. However in cancer cells, some~     important proteins, which help control cell growth, start to behave abnormally resulting in~     faster growth and multiplication. In this study, we are looking at a protein called AKT that~     helps the cancer cells to develop. Blocking the action of AKT with a drug like AZD5363 may~     slow down or stop the cancer growing. The development of AZD5363 is intended to provide a new~     treatment option for patients with cancer. The standard chemotherapy agent, Paclitaxel, is~     given to destroy cancer cells. AZD5363 may also make the cancer more sensitive to Paclitaxel~     and so make this agent more effective.~      A gene called PIK3CA has an important relationship with AKT. In tumours where this gene has~     been altered, or said to have 'mutated', the response to AZD5363 may be better. PIK3CA~     mutations are found commonly in breast cancers, and we will test for the presence of these~     mutations in both blood and tumour tissue samples that we ask you to provide. This study will~     also look at the relationship between tumours with PIK3CA mutations and the effect of the~     treatment.~   "
87455|NCT02422342|"~     The objectives of the clinical trial is to validate hemodynamic parameters (Blood pressure~     and Cardiac Output) generated by an application coupled with an off-the-shelf pulse oximeter.~     The validation will be done by comparing the generated information to data gathered while~     performing Stress Echocardiography. The first phase of the study will be done on 10 patients~     undergoing a Stress Echocardiography test at the cardiology department at Meir Hospital~   "
87359|NCT02423590|"~     This study is being carried out to see if a new drug called Apatorsen in combination with~     standard gemcitabine/carboplatin chemotherapy is effective in treating squamous cell lung~     cancer.~      This study is part of a research project for collecting information about the effectiveness~     and safety of Apatorsen when used with gemcitabine/carboplatin chemotherapy. The main purpose~     of this study is to see if Apatorsen, when combined with gemcitabine/carboplatin, is an~     effective treatment for squamous cell lung cancer.~      Recent research has found that a protein called Hsp27 can help cancer cells protect~     themselves against the effects of cancer treatments. Hsp27 is only found in some lung cancers~     but when it is present, cancer drugs might not work as well as they would without Hsp27 being~     present. Blocking the action of Hsp27 or removing Hsp27 from cancer cells with Apatorsen may~     slow down or stop the cancer growing. This study will therefore look at the relationship~     between the Hsp27 levels in tumour and blood and the effect of the treatment.~      The development of Apatorsen is intended to provide a new treatment option for patients with~     cancer. Apatorsen may also make the cancer more sensitive to gemcitabine and carboplatin and~     so make this chemotherapy treatment more effective.~   "
87360|NCT02423577|"~     The purpose of this study are to determine the effect FF-3 in comparison to placebo in~     subjects who are experimentally inoculated with a live, challenge strain of influenza A~     virus.~   "
87361|NCT02423564|"~     This investigation will evaluate the effect of Digesta-Lac in adults with occasional~     constipation in a single-center, randomized, double-blind, placebo-controlled, parallel group~     2-arm study for 3 weeks.~   "
87362|NCT02423551|"~     The objective of this study is to determine the impact of consuming MREs as the sole source~     of subsistence for 21 days on gut bacteria community composition and gut health. Up to 80~     free-living adults will be randomized to consume their usual diet or only MREs for 21~     consecutive days. MREs will be provided by the Military Nutrition Division, US Army Research~     Institute of Environmental Medicine (USARIEM). Fecal, urine and blood samples will be~     collected periodically before, during and after the intervention to measure gut barrier~     integrity, gut bacteria community composition, and markers of gut health, inflammation, and~     nutritional status.~   "
87363|NCT02423538|"~     The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD)~     oral doses of SHR0302 compared to placebo. Also, pharmacokinetics (PK) and pharmacodynamics~     (PD) of SHR0302 after single oral administration will be evaluated, and, if applicable, the~     maximum tolerated dose determined.~   "
87364|NCT02423525|"~     The purpose of this study is to try to determine the maximum safe dose of afatinib that can~     be administered to people with brain cancer. Other purposes of this study are to:~        -  find out what effects (good and bad) afatinib has;~        -  see how much drug gets into the body by collecting blood and cerebrospinal fluid for use~          in pharmacokinetic (PK) studies;~        -  learn more about how afatinib might affect the growth of cancer cells;~        -  look at biomarkers (biochemical features that can be used to measure the progress of~          disease or the effects of a drug).~   "
87365|NCT02423512|"~     Vedolizumab is a new medication being used for the treatment of Crohn's disease and~     Ulcerative colitis. It works by blocking specific white blood cells (alpha 4-beta7~     lymphocytes) from migrating to areas of inflammation in the gastrointestinal tract. Previous~     studies have shown that patients who have previous exposure to another type of medication for~     Crohn's disease and Ulcerative colitis (anti-TNF medications) do not respond to vedolizumab~     as well as those who have never been exposed. This study will investigate biologic markers in~     the blood and tissue the help identify possible reasons for this difference.~   "
87366|NCT02423499|"~     The objective of this study is to identify the specific characteristics of Autism Spectrum~     Disorder (ASD) in emotional response profiles and shared with Bipolar Disorder (BD)~     characteristics.~   "
87367|NCT02423486|"~     The aim of this study is to compare the efficacy between Electromagnetic Stimulation therapy~     and Electromagnetic Stimulation therapy with Extracorporeal Biofeedback in Stress Urinary~     Incontinence patient.~   "
87368|NCT02423473|"~     The aim of the present study is to evaluate the clinical, aesthetic and patient-centered~     parameters of connective tissue graft associated or not with composite resin for the~     treatment of gingival recession.~   "
87369|NCT02423460|"~     The daily requirement of threonine, an essential amino acid, will be evaluated in healthy~     adult males and in adult males with Crohn's Disease or ulcerative colitis using the indicator~     amino acid oxidation (IAAO) method. Participants will consume specially formulated diets with~     varying levels of threonine.~   "
87370|NCT02423447|"~     It is the goal of the proposed study to compare the efficacy, as assessed primarily by sputum~     weight, of these two different devices (the Electroflo 500 and the G5 Flimm-Fighter) for~     airway clearance (AC) in CF patients with mild to moderate lung disease, who have stable lung~     health and perform AC at home as part of their routine therapeutic regimen.~   "
87371|NCT02423434|"~     Through the multinational pooled dataset approach, this trial will aim to derive and validate~     specific in vivo Corneal Confocal Microscopy (CCM) parameter thresholds for the~     identification of diabetic polyneuropathy, and - more importantly - the identification of~     individuals at future risk. Results of the study will permit application in clinical practice~     and intervention trials for diabetic polyneuropathy (DPN) risk stratification.~      The primary goal of the study is to re-examine individuals with type 1 and type 2 diabetes~     with and without neuropathy, who had CCM performed in the past as a part of their~     neurological examination, to assess concurrent and predictive validity of different CCM~     parameters in individuals . These subjects will be invited to the study to be re-examined by~     CCM along with other neurological tests (physical exam, nerve conduction studies,~     quantitative sensory testing, blood test and in some centres also skin biopsy) during the~     single study visit. Additionally CCM data will be analyzed both manually and by recently~     developed automated analytical software to evaluate accuracy of the automated method.~     Evaluation of automated image analysis will influence likelihood of successful knowledge~     translation of this surrogate biomarker for DPN into clinical practice - in which the~     procedure could be harmonized with annual retinal examinations - and into intervention~     trials.~      Secondary aim of the study is to determine the factors associated with CCM parameters and~     their longitudinal change and collect bio-samples for future research in this field.~   "
87372|NCT02423421|"~     The purpose of thus study is to determine if faecal microbiota transplantation will result in~     improvement in clinical outcomes in patients with irritable bowel syndrome.~   "
87374|NCT02423395|"~     Muscle cramps are common in patients with liver disease and associated with significantly~     diminished quality of life. Patients with cirrhosis often experience muscle cramps with~     varied frequency and severity. The exact mechanisms by which they occur remain unclear,~     although a number of pathophysiological events unique to liver disease may contribute.~     Clinical studies have identified alterations in 3 areas: nerve function, energy metabolism,~     and plasma volume/electrolytes (1) Orphenadrine is an anticholinergic drug with prominent~     central nervous system (CNS) and peripheral actions used to treat painful muscle spasms and~     other similar conditions. The combination of anticholinergic effects and CNS penetration make~     orphenadrine useful for pain of all etiologies, including from: radiculopathy, muscles, and~     headaches. [3,4]~   "
87375|NCT02423382|"~     The purpose of this study is to evaluate the effects of long-term tamponade with silicone oil~     on retinal saturation with Oxymap.~   "
87376|NCT02423369|"~     The purpose of this study is to assess whether peri-operative period in neonates and infants~     is associated with an increase in blood biomarkers, specific for neuronal injury, and to~     correlate them with clinical variables and sedative/analgesic agents. Patients, who meet~     inclusion criteria and does not meet exclusion criteria, are enrolled. Blood samples for~     measurement serum concentrations of markers (S100-B and Neuron-Specific Enolase (NSE)) are~     drawn before surgery (baseline) and on the 1-st, 2-nd and 3-rd day after surgery. During~     surgery cerebral oxygenation (rSO2) monitoring is continuously applied; rSO2, hemodynamic and~     respiratory values are simultaneously recorded every 5 minutes. Anesthesia, pre and~     postoperative treatment, including analgesia and sedation, are given as per standard of care.~   "
87377|NCT02423356|"~     The purpose of this study is to investigate the heart functioning of patients being treated~     with with doxorubicin chemotherapy who have sarcoma, lymphoma or breast cancer in order to~     better predict risk of developing symptomatic heart failure.~   "
87378|NCT02423343|"~     The main purpose of this study is to evaluate the safety, tolerability, and efficacy of the~     study drug known as galunisertib in combination with nivolumab in participants with advanced~     refractory solid tumors and in recurrent or refractory non-small cell lung cancer (NSCLC) or~     hepatocellular carcinoma (HCC).~   "
87379|NCT02423330|"~     This clinical trial will evaluate the safety and efficacy of the Strattice-LIFT procedure to~     treat anal fistulas.~   "
87380|NCT02423317|"~     The Airtraq optical laryngoscope has recently been available in pediatric sizes. The~     investigators compared the efficacy of Airtraq with the Miller laryngoscope as intubation~     devices in paediatric patients. This prospective, randomized study was conducted in a~     tertiary care teaching hospital. Sixty American Society of Anesthesiologists (ASA) grade I-II~     paediatric patients of 2-10 years, posted for routine surgery requiring tracheal intubation~     were randomly allocated to undergo intubation using a Miller (n = 30) or Airtraq (n = 30)~     laryngoscope. The primary outcome measures were time of intubation, ease of intubation,~     number of attempts and POGO score. We also measured hemodynamic changes and airway trauma.~   "
87381|NCT02423304|"~     50 periodontitis 50 healthy individuals serological evaluation will done to see association~     of 77A/G AND 11A/12A gene polymorphisms of MMP-13~   "
87382|NCT02423291|"~     Study Objectives Primary:~      • To determine the antitumor efficacy of single-agent Brentuximab vedotin (1.8 mg/kg~     administered intravenously every 3 weeks) as measured by the overall objective response rate~     in patients with relapsed or refractory primary mediastinal large B-cell lymphoma.~      Secondary:~        -  To assess duration of tumor control, including duration of response and progression-free~          survival~        -  To assess survival~        -  To assess the safety and tolerability of Brentuximab vedotin~      Additional:~      • To assess disease-related symptoms~      Number of Planned Patients 20 patients will be enrolled in this study. Duration of the study~     The study duration is 18 months for enrollment and 2 years for the follow-up.~   "
87383|NCT02423278|"~     The main purpose of this study is to evaluate the effect of extensive lymphadenectomy~     procedure in treatment of gastric cancer. This study is designed as a open-label,~     multi-centers, randomized controlled trial. The overall survival and free disease survival~     are primary outcomes, with postoperative complication, hospital charges, and life quality as~     secondary outcomes.~   "
87384|NCT02423265|"~     Anti-anginal drugs relieve ischemia and symptoms by reducing myocardial oxygen demand by~     reducing heart rate and or contractility (beta-blockers, phenylalkylamine and~     benzothiazepineate classes of calcium antagonists) or vasodilatation of the venous system~     (fall in pre-load) and coronary vessels.~      Late sodium channels remain open for longer in the presence of myocardial ischaemia.~     Ranolazine, a novel anti-anginal agent, acts by inhibiting the inward late inward sodium~     current (INaL), reducing intracellular sodium accumulation and consequently intracellular~     calcium overload via the sodium/calcium exchanger. It is currently thought that this~     reduction in intracellular calcium reduces diastolic myocardial stiffness and therefore~     compression of the small coronary vessels. There is considerable animal data to support this~     theory.~      There are good theoretical reasons to postulate that patients with chronically occluded~     vessels may derive less benefit from conventional anti-anginal agents, particularly~     vasodilators. The ischemic myocardium, subtended by the occluded vessel, will already be~     subject to significant concentrations of paracrine vasodilators such as adenosine.~     Ranolazine, therefore, may on the basis of its mechanism of action, provide greater relief of~     ischemia in such patients than conventional anti-anginal agents.~   "
87385|NCT02423252|"~     The purpose of this study is to investigate whether a psycho-cognitive nursing intervention~     including relaxation, guided imagery, touch and music listening can improve the clinical and~     psychological outcome of critically ill patients. The investigators hypothesize that,~     patients who receive the proposed psycho-cognitive nursing intervention will report lower~     stress, less pain and have altered level of stress neuropeptides in peripheral blood, lower~     levels of inflammatory molecules, less complications and better self reported lived~     experience than patients who receive standard care alone.~   "
87456|NCT02422329|"~     The goal of this research study is to learn how patients' think about constipation before and~     after receiving education about the subject.~   "
87557|NCT02421016|"~     The bioresorbable polymer SYNERGY EES exhibits a favourable vascular healing profile in~     patients undergoing coronary intervention for de novo lesions. Specifically, the SYNERGY EES~     is superior to the ABSORB bioresorbable vascular scaffold in terms of antirestenotic efficacy~     as assessed by angiography at 6-8 months.~   "
87386|NCT02423239|"~     This study is a trial of dexanabinol in patients with advanced tumours. The purposes of the~     protocol are to study different doses of the study drug to determine the maximum safe dose of~     the drug given in combination with standard chemotherapies and to further understand the~     safety of the study drug and to measure any reduction in size of patients' cancer tumour(s).~      Dexanabinol is a synthetic cannabinoid which has previously undergone clinical trials for~     traumatic brain injury (TBI) and in subjects undergoing coronary artery bypass surgery.~     Currently dexanabinol is under investigation for potential anti-tumour activity in patients~     with advanced tumours.~   "
87387|NCT02423226|"~     The purpose of this study is to evaluate the safety and efficacy of CT guided 125I seeds~     implant plus systemic chemotherapy for locally recurrent rectum cancer.~   "
87388|NCT02423213|"~     Optical coherence tomography (OCT )provides high resolution information regarding the~     anatomic structure of the tissues of the eye in a cross-sectional and 3 dimensional view.~     Much of this information is not able to be visualized by a clinician. Utilizing this~     information during surgery will allow for the ophthalmic surgeons to better understand how~     surgical procedures impact the anatomic structure of the eye.~      In this study an OCT device that has been built into the microscope (rather than mounted on~     the side or held in the surgeon's hand) and will be utilized to take images at various~     milestones during surgery to assess feasibility and potential utility of this technology.~     Since it is built into the microscope, there are potential significant advantages over a~     separate system including increased efficiency, improved working distance, and the ability to~     visualize tissue-instrument interactions.~   "
87389|NCT02423200|"~     This study will assess the effects of VX-745 on markers of disease in the central nervous~     system of patients with MCI due to AD or with mild AD. The study will also evaluate the~     safety and tolerability of VX-745 in these patients during 6 weeks of dosing, as well as the~     plasma and cerebrospinal fluid concentrations of VX-745 during dosing.~   "
87390|NCT02423187|"~     To investigate the safety and efficacy of long-term combination therapy with rabeprazole and~     low-dose aspirin.~   "
87391|NCT02423174|"~     The objective of the clinical trial is to determine the suitability of the FMwand~     Ferromagnetic Surgical System for Total Mesorectal Excision Surgery.~   "
87392|NCT02423161|"~     OCT provides high-resolution information regarding the anatomic structure of the tissues of~     the eye in a 2-dimensional and 3-dimensional view. Much of this information is not able to be~     recognized by a clinician. Utilizing this information during surgery will allow for~     ophthalmic surgeons to better understand how surgical procedures impact the anatomic~     structure of the eye.~   "
87393|NCT02423148|"~     This research study is studying a new imaging method that will show lymph nodes in the lung~     during lung cancer surgery. The name of the study intervention involved in this study is:~      -- The combination of the FluoSCOPE device and Indocyanine Green~   "
87394|NCT02423135|"~     The aim of the proposed project is to perform a clinical study in which volunteers will~     receive autologous blood transfusions in DEHP-free blood bags.~   "
87395|NCT02423122|"~     This study will assess the effects of administration of VX-745 for 12 weeks on amyloid plaque~     burden in Alzheimer's disease (AD). Subjects who meet entry criteria will undergo 11C-PiB~     (Carbon-11-labeled Pittsburgh Compound B) positron emission tomography (PET) at baseline and~     after 45 days of dosing with VX-745. Cognitive testing will also be conducted at baseline and~     day 45.~   "
87396|NCT02423109|"~     Bilateral dispensing clinical trial of fanfilcon A toric lens verses enfilcon A toric lens~     over two weeks.~   "
87397|NCT02423096|"~     Background: Schizophrenia is a serious mental illness. The diagnosis and severity evaluations~     of schizophrenia are generally based on patient behaviors. Biomarkers are objectively~     measured and used as indicators for diagnosis confirmation, symptom assessment, and~     evaluation of pharmacologic responses to therapeutic interventions. Neuroendocrine and~     metabolite substrates are potential biomarkers of the pathogenic processes in schizophrenia.~      Aims: The aims of this study are to determine (a) the differences in neuroendocrine and~     metabolite substrates between patients diagnosed with schizophrenia and healthy controls; and~     (b) the associations among the neuroendocrine and metabolite substrates, cognitive function,~     clinical symptoms, and treatment responses of patients diagnosed with schizophrenia.~      Methods: (a) The investigators plan to recruit 100 patients diagnosed with schizophrenia and~     100 healthy controls as participants. (b) At the baseline and Week 12, patient blood samples~     will be obtained to measure the levels of neuroendocrine substrates and metabolite markers.~     Clinical symptoms and cognitive function will be evaluated. (c) For the healthy control~     participants, blood samples will be obtained once to measure neuroendocrine and metabolite~     marker levels.~      Expected Results: The results of this study may contribute to identifying potential~     neuroendocrine and metabolite biomarkers of schizophrenia, and clarify the associations among~     the neuroendocrine and metabolite substrates, cognitive function, clinical symptoms, and~     treatment responses of patients diagnosed with schizophrenia. Such information is crucial for~     clinical evaluations and future research.~   "
87402|NCT02423031|"~     Background:~      - Medical problems and treatments can cause stress in some people. Researchers want to learn~     more about how to measure distress in young people with medical illnesses. A screening tool~     called Checking In will be developed in order to help researchers find ways to identify~     concerns and stresses common to this group.~      Objective:~      - To create a screening tool that will help health care providers identify psychological and~     social distress in young people with serious illnesses.~      Eligibility:~      - Outpatient youth ages 8 21 who are enrolled on a research protocol at the NIH at the time~     of the study.~      Design:~        -  Phase 1 participants will complete a paper-and-pencil version of Checking In. It asks~          about mood, pain, fatigue, peer relationships, and sleep. During this phase,~          participants will be asked about the wording of the questions in Checking In. They will~          also talk about what they thought of the questions and if they understood them.~        -  Phase 2 will not involve participant enrollment. During this phase the researchers will~          be working with technologists to develop the software for an electronic version of~          Checking In.~        -  Phase 3 participants will complete an electronic version of Checking In. Researchers~          will ask questions about the ease or difficulty of using an electronic screen.~        -  Phase 4 participants and one of their caregivers will complete an electronic version of~          Checking In. They will also complete other questionnaires related to mood, pain fatigue,~          peer relationships and sleep. They will be asked their thoughts about using Checking In.~          On the same day, their NIH doctor will get summary data about their questionnaire~          answers. The doctor will also provide feedback about the summary form.~        -  Researchers will compare data from Checking In with data from the other questionnaires.~   "
87403|NCT02423018|"~     The purpose of this study is to determine if a single dose of pregabalin 300mg in patients~     receiving medications for sedative-hypnotic withdrawal symptoms will produce meaningful~     differences in measures of drug liking and drug high as compared to placebo.~   "
87398|NCT02423083|"~     Background:~      - People with multiple sclerosis (MS) get lesions in their brain and spinal cord. These cause~     neurological symptoms and sometimes disability. Researchers want to see if a blood pressure~     drug called guanabenz can repair lesions and help people with MS.~      Objective:~      - To see if guanabenz is safe and well tolerated in people with MS.~      Eligibility:~      - People 18 55 years old with MS who have taken glatiramer acetate for the past year.~      Design:~        -  Participants will be screened in a separate protocol. For 2 months, they will be~          examined and have magnetic resonance imaging (MRI) scans. This will decide if they are~          in the Stable or Active MS study group.~        -  The study will last 5 months. There will be up to 11 visits, 5 overnight.~        -  Visit 1: overnight stay at the clinic:~        -  Medical history and physical exam.~        -  Health questionnaire~        -  Bladder ultrasound scan~        -  Brain MRI~        -  Electrocardiogram (EKG) to measure heart electrical activity~        -  Blood will be drawn through an intravenous (IV) line.~        -  Participants may have tests of strength, muscle tone, and movement.~        -  They will get their first dose of the study drug, a tablet taken once a day.~        -  Participants will take the study drug at home and keep a medicine diary.~        -  The dose will slowly increase. Each time, participants will stay overnight at the~          clinic. They will have a physical exam, EKG, MRI, and IV blood draw.~        -  Visit 6: Participants will have a physical exam, MRI, and blood drawn. They will get a~          schedule to slowly lower their drug dose and stop taking guanabenz.~        -  Participants will have 2 final visits. They will have a physical exam, EKG, MRI, and IV~          blood draw.~   "
87399|NCT02423070|"~     Background:~      - Some people with advanced heart and lung disease have heart and lung transplants. But the~     organs are often rejected. When this happens, the organ recipients must have repeated~     biopsies. These are invasive and expensive. Researchers want to see if a blood test can~     predict rejection and take the place of biopsies. The test shows how much donor DNA is in a~     recipient s blood.~      Objective:~      - To see if a new blood test can be used instead of biopsies to diagnose rejection after~     transplant.~      Eligibility:~      - Adults 18 years and older who are on the lung or heart transplant waitlist.~      Design:~        -  Participants will have about 4 teaspoons of blood drawn from the arm before having their~          transplant.~        -  Researchers will collect demographic data about participants. They will also collect~          basic medical information about their condition.~        -  After surgery, while still in the hospital, participants will have 2 teaspoons of blood~          drawn twice a week until they go home.~        -  At each biopsy visit after the transplant, participants will have 4 teaspoons of blood~          drawn for testing for up to 5 years.~   "
87400|NCT02423057|"~     Background:~      - Genes are made up of DNA and are the instruction book for cells. When people have cancer,~     some of the genes that might have slowed the growth of tumor cells were turned off.~     Researchers think a drug called TdCyd might help to turn these genes back on. This may slow~     the growth of tumors in people with cancer.~      Objectives:~      - To test the safety of TdCyd and to find out how it works. Also, to find out the dose of the~     drug that can be safely given to humans.~      Eligibility:~      - Adults 18 years and older who have advanced cancer that has progressed after standard~     treatment, or for which no effective therapy exists.~      Design:~        -  Participants will take TdCyd by mouth. The drug is given in 21-day cycles. TdCyd is~          taken once a day during week 1 for 5 days. Then for 2 days participants do not take the~          drug. Then they take it for 5 days during week 2. No TdCyd is taken during week 3.~        -  Participants will keep a diary of their study drug doses.~        -  Participants will have tests about every 3 weeks to see how the study drugs are~          affecting their body. They will have blood and urine tests, a medical history, and~          physical exams. They may have computed tomography (CT) scans to measure their tumors.~          They may have an electrocardiogram, which measures the heart electrical activity.~        -  If participants develop any side effects, they may be asked to visit more often.~        -  Participants will stay in the study as long as they are tolerating TdCyd and their~          tumors are either stable or getting better. One month after stopping the drug, they will~          have a follow-up phone call.~   "
87401|NCT02423044|"~     Background:~      - Fear is a normal response to a threat. Learning fear can be helpful sometimes. For people~     with anxiety disorders, fear can be long-lasting and too intense. Researchers want to study~     how people become fearful of situations. They want to understand how the brain learns when it~     is helpful to feel fear and when it is not.~      Objective:~      - To better understand brain processes related to fear and anxiety.~      Eligibility:~        -  Right-handed adults ages 18 50 with generalized anxiety disorder, panic disorder, social~          anxiety disorder, or post-traumatic stress disorder.~        -  Right handed volunteers ages 18-50 without psychiatric disorders.~        -  And free of psychiatric medication for 2 weeks~      Design:~        -  Participants will first be screened under another protocol.~        -  Participants will play a video game inside a magnetic resonance imaging (MRI) scanner.~          The scanner is a metal cylinder It is surrounded by a strong magnetic field.~          Participants will lie on a table that can slide in and out of the scanner. A device~          called a coil will be placed over the head.~        -  During the scan, participants may play a virtual reality video game. Game instructions~          will be explained before they enter the scanner.~        -  While playing the game, participants will wear 2 electrodes on their fingers. These~          measure sweat on the skin. They will also have 2 small electrodes attached to the left~          hand. These can give brief mild electrical shocks.~        -  Participants will be asked questions when playing the game during the scan.~        -  Before and after the scan, participants will fill out questionnaires about their~          emotions. They may complete questionnaires online while at the clinic.~   "
87404|NCT02423005|"~     A prospective, randomised, controlled, single-blind, multi-site clinical study employing~     Neuromuscular Electrical Stimulation (NMES) to stimulate the pelvic floor muscles of women~     suffering from stress urinary incontinence.~      Approximately one-hundred and eighty (180) female patients diagnosed with stress urinary~     incontinence will be enrolled in this study. All patients who are considered eligible to~     participate in the clinical study and give consent will be randomised to complete either a~     12-week treatment programme with the Neurotech Vital Compact device or a 12-week treatment~     programme with the itouch Sure Pelvic Floor Exerciser. The 12-week treatment programme will~     be completed by the subjects at home with treatment with the device in accordance with the~     device Instructions for Use.~   "
87406|NCT02422979|"~     This is a two-part clinical study of patients with recurrent Head and Neck Cancer (HNC), who~     in the opinion of their physician, cannot be satisfactorily treated with surgery, radiation~     or platinum chemotherapy. The purpose of the study is to determine the safety and anti-cancer~     activity of various doses and repeated cycles of the experimental treatment using the study~     drug RM-1929 and fixed amounts of red light applied at the tumor site to activate the~     pharmacodynamics of the drug.~      The part 1 of the study has been completed and consisted in a single cycle, 3+3 dose~     escalation safety study of the experimental drug RM-1929 using a fixed amount of 690 nm red~     light. The part 1 was designed to determine the safety of the treatment as set by the maximal~     feasible dose or the maximal tolerable dose of RM-1929. From the part 1 results, the maximal~     feasible dose of RM-1929 was determined.~      The part 2 of the study is currently ongoing and it is evaluating the safety and anticancer~     efficacy of up to four repeated treatments of Photoimmunotherapy with RM-1929 at the maximal~     feasible dose of RM-1929 activated with a fixed amount of red light.~   "
87407|NCT02422966|"~     The purpose of the study is to assess the efficacy and safety of paracetamol in comparison to~     ibuprofen in the treatment of patent ductus arteriosus (PDA) in preterm infants.~   "
87408|NCT02422953|"~     Widespread food insecurity and malnutrition are largely the main impairing factors for human~     capital development in Pakistan. Rates of chronic malnutrition are very high, and acute~     malnutrition is critical: 44% of children under five are stunted and nationwide global acute~     malnutrition (GAM) rates amongst children under five exceed the WHO critical threshold of~     15%. Nutritional status trends also show a deteriorating situation since 1994, when stunting~     rates were at 36%.~      This study evaluates the effectiveness of food based interventions to prevent stunting among~     children under-five years with focus on window of opportunity (1000 days from conception to 2~     years) for addressing stunting. Pregnant women, lactating mothers and children 6-59 months~     will receive supplements on monthly basis in intervention areas, while participants in~     control areas will receive routine public health services available in the study area.~   "
87409|NCT02422940|"~     This is an extension study to evaluate the long-term safety, tolerability, and efficacy of~     two dose strengths of dalfampridine-ER twice daily tablets when administered for at least 12~     months to subjects with chronic post-ischemic stroke walking deficits who have completed the~     controlled, double-blind Study DALF-PS-1016.~   "
87410|NCT02422927|"~     The investigators tested if a nutraceutical combination with red yeast rice, berberine and~     policosanol (NC) can significantly modify inflammation, lipid profile and markers of~     endothelial injury (endothelial microparticles) in subjects with elevated levels of~     high-sensitivity C-reactive protein (hsCRP).~   "
87411|NCT02422914|"~     Background. Smoking is considered a global public health problem. For this reason, the~     smoking dependence was called by experts as a global epidemic.~      Over the past three years, this electronic devices (Tobacco Free Cigarettes, or TFC) has been~     an important expansion in many countries. Nevertheless, there is poor evidence that TFC are~     beneficial for smoking cessation. In particular, even though it has been proved that the~     nicotine replacement devices helps many individuals to give up smoking and to tolerate the~     withdrawal symptoms, it is still unclear their long-term effect. Hence, it must be tested its~     contribution in tobacco reduction. This protocol in particularly innovative, since it aims to~     test the efficacy of electronic devices in a screening program (the lung cancer prevention~     program COSMOS II at the IEO), where tobacco reduction is strictly needed in order to lower~     individual's risk.~      Methods and Design. This experimental protocol has been designed with the main aim to~     investigate the role of Tobacco Free Cigarettes (TFC), also called e-cigarettes, in helping~     smokers to improve their lung health and to quit or reduce tobacco consuming. In particular,~     the investigators aim at investigating clinical (physical symptoms, with particular focus on~     breathing quality and difficulties), the behavioral (number of tobacco cigarettes smoked),~     and psychological (wellbeing, mood and quality of life) effects of shifting to TFC.~      The investigators will also analyze, as a secondary aim, the psychological and lifestyle~     component of smokers involved in order to fine correlation data that might be used to compute~     a predictor index able to suggest the probability of success, with respect to the reduction~     of tobacco consuming, of the use of a TFC and to maintain the abstinence. The study will be~     organized as a nested randomized controlled study with two arms: one experimental group and~     one control group. The study will be nested in the screening program for lung cancer, where~     subjects will be recruited.~      All subjects will be entered in a psycho-cognitive low-intensity counseling program (6~     months), but in the experimental group a TFC (with or without nicotine) will be used as~     replacement device for three months, while in the control group only low-intensity counseling~     will be provided. Furthermore, a low-cost non-invasive electronic device (the FitBit activity~     tracker) will be used in order to monitor behavioral (lifestyle), sleep quality and physical~     activities.~   "
87412|NCT02422901|"~     The aim of this long-term observational study is the documentation of the use of PASCORBIN®~     7.5 g in patients with vitamin C deficiency. Regarding the vitamin C deficiency, the~     investigators focus on the acquisition of data of the underlying diseases and the reduction~     of symptoms, that are related to oxidative stress and vitamin-C-deficiency. Next to this,~     exact assessment of medical tolerance and details of treatment requirements are further aims.~     Here the investigators take into account acute and chronic underlying medical conditions.~     Further health economic data are collected.~   "
87413|NCT02422888|"~     The current trial will compare the protective effect of ticagrelor and prasugrel on~     microvascular dysfunction in patients with revascularized ST elevation myocardial infarction.~   "
87414|NCT02422875|"~     The purpose of this study is to compare immune phenotype, function, and specificity of B~     lymphocytes from different developmental stages in autoimmune patients to B cells from~     infectious disease patients and healthy controls.~   "
87415|NCT02422862|"~     Frequently, headache is associated with disorders of the cervical spine, specially on the~     upper cervical spine. Therefore, restoration of the upper cervical mobility is considered~     fundamental for the treatment of headache.~      Manual therapy interventions seek to restore upper cervical mobility through a wide range of~     therapeutic procedures, including mobilization or manipulation techniques. Previous~     systematic reviews reported preliminary evidence for the application of upper cervical manual~     therapy techniques for the management of headache.~      The objective of this study is to study the effects of upper cervical translatoric spinal~     mobilization (UC-TSM) on headache intensity, cervical mobility and pressure pain threshold in~     subjects with headache. For this purpose, the investigators will conduct a randomized~     controlled trial. Volunteers with headache will participate in the study and will be randomly~     divided into control or treatment group. Treatment group will receive UC-TSM and the control~     group will receive no treatment.~      Headache intensity, cervical mobility, temporomandibular mobility and pressure pain~     thresholds (PPT) will be measured before and immediately after each treatment session (3~     treatment sessions in one week period) and after one month follow-up. At this moment, global~     perceived effect will be assessed.~   "
88731|NCT02405676|"~     The purpose of this study is to test whether adding 4 injections of rituximab and increasing~     the intensity of chemotherapy regimens in advanced patients can improve the EFS compared with~     the historical study CCCG-NHL-2010.~   "
87416|NCT02422849|"~     the elderly population (+ 65 years) is increasing. Acute medical conditions often leads to~     hospital admissions in this age group. However hospital admission is linked to adverse~     events. like confusion, medication errors or new infections.~      the ACCESS project aims to examine alternatives to acute admissions for senior medical~     patients.~      the aims are:~        1. How many patients will be admitted to hospital due to acute medical conditions if cared~          for by their own General Practitioner (GP) versus a hospital intern specialist ?~        2. how many patients will be admitted to hospital due to acute medical conditions if cared~          for by acute team in their home versus in specialised care centres ?~   "
87417|NCT02422836|"~     The subjects will use the test skincare products. This is a full face, twice daily~     application study, with digital photos and expert grader evaluations at Baseline, 4 and 8~     week periods. If the subject meets the study criteria and is enrolled, they will be~     instructed at screening visit to discontinue the use of any facial products (except dry~     mineral foundation and eye make-up) for seven (7) days before beginning the study (referred~     to as the washout period). They will return to the site for the baseline visit 2 after the~     required 7 day washout period (visit can occur within 1 week after screening visit).~   "
87418|NCT02422823|"~     Ninety patients with irreversible pulpitis diagnostic will participate in this clinical~     study. The participants will be divided into 2 groups of 45 patients, who will receive the~     inferior alveolar nerve block injections of 1.8 mL of 4% articaine (Articaine 100; DFL, Rio~     de Janeiro, RJ, Brazil) with 1:100,000 epinephrine or 3.6mL of the same solution. Two~     consecutive negative responses to the maximum pulp stimulus (80 µA) at the electric pulp test~     were the criterion to determine a pulpal anesthesia as successful. Ten minutes after the IAN~     block, subjective lip anesthesia will be evaluated by asking the patient whether his/her lip~     was numb. Thereafter and immediately before the pulpectomy, the electric pulp stimulations~     will be repeated to determine pulpal anesthesia. During the pulpectomy procedure, the~     patients were instructed to report any painful discomfort. To evaluate the intensity of pain~     during the pulpectomy, a verbal analogue scale will be used. The anesthesia will be defined~     as successful when the dentist accessed the pulp chamber without pain being reported by the~     patient. In these cases, the pulpectomy will be continued. If report pain will classified the~     IAN block as unsuccessful.~   "
87419|NCT02422810|"~     The purpose of this study is to characterize a new test to assess the rate and time it takes~     to form a blood clot in people who either do or do not take aspirin.~   "
87420|NCT02422797|"~     The aim of this study is to determine if virologically suppressed, human immunodeficiency~     virus type 1 (HIV-1) infected adults on an antiretroviral regimen (including 2 nucleoside~     reverse transcriptase inhibitors [NRTIs] plus a third agent) remain suppressed upon switching~     to a two-drug regimen with dolutegravir (DTG) + rilpivirine (RPV). The study will primarily~     assess the non-inferiority antiviral activity of switching to DTG + RPV once daily compared~     to continuation of current antiretroviral regimen (CAR) up to Week 48 with a switch visit for~     eligible subjects in the CAR group to initiate DTG + RPV therapy at Week 52. CAR will include~     2 NRTIs plus 1 HIV-1 integrase inhibitor (INI), or 1 non-nucleoside reverse transcriptase~     inhibitor (NNRTI), or 1 protease inhibitor (PI). The study will include a 148-week open-label~     treatment phase, comprising of an Early Switch Phase (Day 1 to Week 52) and a Late Switch~     Phase (Week 52 to Week 148). The participants fulfilling the study eligibility criteria will~     participate in the Early Switch Phase where they will either switch from their CAR to DTG +~     RPV, or continue taking their CAR, until Week 52. At the end of Early Switch Phase, eligible~     participants will proceed to the Late Switch Phase where all participants in both DTG + RPV~     and CAR treatment groups will receive DTG + RPV therapy until Week 148. After Week 148,~     subjects may be eligible to continue to receive DTG +RPV in the Continuation Phase. The study~     is planned to be conducted in approximately 476 participants.~   "
87421|NCT02422784|"~     This is a cross-sectional study designed to compare plasma/serum and urine vitamin D~     metabolite profiles of vitamin D sufficient and insufficient individuals.~      There are two phases of this study.~      Phase 1 - Consented study participants will attend a screening visit and provide a fasting~     blood and urine sample. Those individuals who are vitamin D insufficient based on serum~     25(OH)D concentrations will be invited to participate in Phase II~      Phase II - is a double-blind, randomized, control study designed to examine vitamin D status~     in vitamin D insufficient individuals consuming a water-soluble form of vitamin D3. Eligible~     participants will be asked to consume one of three beverages: i) rooibos iced-tea (control);~     ii) rooibos iced-tea fortified with 1000 IU of water-soluble vitamin D3; or iii) rooibos~     iced-tea fortified with 1000 IU of water-soluble vitamin D3 and 360 mg calcium at 240 mL of~     iced-tea consumed daily for 6 weeks. Participants will attend 6 weekly visits following~     baseline and provide a fasting blood sample for assessment of serum 25(OH)D concentrations.~      Objectives: 1) To investigate plasma/serum and urine vitamin D metabolite profiles in vitamin~     D sufficient and insufficient individuals; and 2) To determine the effects of vitamin D3~     fortification on serum 25-dihydroxy-vitamin D [25(OH)D] concentrations, markers of vitamin D~     and calcium metabolism, and vitamin D metabolite profile in plasma/serum and urine of vitamin~     D insufficient individuals.~   "
87422|NCT02422771|"~     In response to high injury rates in soccer, the Fédération Internationale de Football~     Association (FIFA) developed an injury prevention program called the 11+. It is designed to~     replace a standard warm-up and takes about 20 minutes to complete. The program has proven~     remarkably effective in decreasing the rate of injury in soccer players. However, uptake of~     the 11+ has been less than desired. Adoption of the program may be increased if additional~     benefits can be demonstrated and the program is introduced at a younger age. The goals of~     this study are to (1)establish that young athletes can tolerate the program, and (2)measure~     the effects of the 11+ program on the physical performance of 10-12 year old girls. Three~     teams will be randomly assigned to the intervention group and carry out the 11+ program for~     the duration of the indoor soccer season. Another 3 teams will continue with their usual~     warm-up. Pre- and post-intervention, balance, agility, core strength and movement control~     will be assessed in all athletes. The investigators hypothesize that the athletes will~     tolerate the program well and that the intervention group will improve on the performance~     tests significantly more than the control group.~   "
88732|NCT02405663|"~     To compare between the effect of controlled cord traction and manual removal of the placenta~     on blood loss among women undergoing caesarean sections~   "
87423|NCT02422758|"~     Perioperative hypothermia brings numerous and recognized postoperative complications. Active~     warming intraoperatively helps to maintain body temperature in the postoperative period, but~     there are few studies in Brazil, assessing the effect of prewarming in maintaining~     normothermia. It is believed that prewarming with forced air warming system keep the body~     temperature during intra and post-operative. This study aims to evaluate the effect on~     prewarming maintaining body temperature of patients undergoing elective surgery of Gynecology~     specialty using the forced air warming system. The study is experimental design, controlled~     type randomized clinical trial, with simple blinding for patients. Eighty adult patients~     undergoing gynecological surgery in the art, with a surgical time of at least an hour will be~     randomized and allocated into experimental groups - prewarming system with forced air warming~     system for 20 minutes, and control - Prewarming with sheet and blanket for 20 minutes. The~     patients will be kept warm during the anesthetic-surgical procedure. The measurement of~     temperature will be using a tympanic thermometer. Participants will be followed from~     receiving the surgical center to the end of surgery. Data will be recorded in validated~     instrument. Data analysis will be used the Model Linear Mixed Effects and the Structure Error~     Auto-Regressive.~   "
87424|NCT02422745|"~     The purpose of this study is to determine whether taking daily, dietary supplements of cocoa~     extract (containing cocoa flavanols and theobromine from the cocoa bean) and/or a standard~     multivitamin reduces the risk of developing cardiovascular disease (including heart attack,~     stroke, coronary revascularization, and cardiovascular mortality) and cancer.~   "
87425|NCT02422732|"~     A monocenter pilot study on the acceptability and feasibility of a functional MRI protocol in~     children with NF1 with or without reading disabilities.~   "
87426|NCT02422719|"~     The purpose of this study is to determine whether radotinib is effective and safe for~     patients with chronic myeloid leukemia, chronic phase who are intolerable or resistant to~     prior 2 or more tyrosine kinase inhibitors.~   "
87427|NCT02422706|"~     Current Helicobacter Pylori infection preferred treatment involves; proton pump inhibitor~     (PPI)-based triple or qudrable regimens. Omeprazole, Amoxicillin, and Clarithromycin is one~     of a global standard care for confirmed H.pylori infection . Metronidazole (MTZ) is used~     instead of Amoxicillin or Clarithromycin in cases of allergy or resistance .~      However, a recent study based on the Maastricht III guidelines, indicated that treatment with~     a PPI-based triple regimen as first-line therapy will fail in ~30% of patients on an~     intention-to-treat (ITT) basis, and will fail in ~ 50 % of patients who treated with~     PPI-based triple regimen with Metronidazole. This treatment resistance is also an issue~     warranting the investigation of other agents. Helicobacter pylori infection has become~     increasingly resistant to traditional first-line treatment regimens because of emerging~     antibiotic resistance coupled with poor patient compliance with completing the treatment~     course that decrease H. pylori eradication rates. So there is a considerable interest in~     evaluating new antibiotic combinations and regimens .~   "
87428|NCT02422693|"~     The goal of this study is to compare the effect of aquatic exercises (AEG) to the aquatic~     exercises plus aerobic training (deep-water running) (AEDWRG) on functional status and pain~     in patients with specific chronic low back pain.~   "
87429|NCT02422680|"~     The study aim to capture key quality indicators and patient satisfaction for at least 500~     patients referred for a colonoscopy at Aalborg University Hospital. The patient population is~     mix of screening and non-screening colonoscopies seen at our out-patient clinic.~      Each Colonoscopy is registered using a specially designed registration form and a more~     detailed form relating to the colonoscopy itself. The data collected includes: Endoscopy~     experience and education, Medicine use, Colonoscopy duration, Caecum Intubations rate and~     documentation, Polyp detection rate, Polyps removed, Cancer detection rate and Nurse assisted~     Gloucester Comfort score. Each patient were given a questionaire with 6 questions answering~     satisfaction, pain, discomfort etc on a 10 cm analog scale.~   "
87430|NCT02422667|"~     The goal of this registry is to review the data collected and research ways to improve~     patient safety, quality of care, and medical decision-making, reduce medical spending, and~     help advance orthopedic science and bioengineering.~   "
87431|NCT02422654|"~     Primary Objective:~      The purpose of this study is to assess the palatability of eliglustat prototype liquid~     formulations in healthy subjects.~   "
87432|NCT02422641|"~     Management of leptomeningeal disease (LMD) in patients with metastatic breast cancer is an~     area of unmet clinical need. High-dose methotrexate (HD-MTX) is known to have activity~     against breast cancer and in contrast to other systemic chemotherapeutics, it penetrates the~     blood brain barrier, targets areas of poor cerebrospinal fluid flow, may penetrate bulky~     leptomeningeal disease, and provide treatment to systemic disease burden. While two~     retrospective studies have suggested activity of HD-MTX in LMD in patients with breast~     cancer, no prospective data are available to inform its inclusion in treatment regimens.~     Thus, while HD-MTX is included in the NCCN Guidelines for LMD and while it is used to varying~     degrees in cancer centers across the nation, this is more representative of the lack of~     available therapies for LMD as opposed to strong evidence-based data. This phase II,~     prospective study will evaluate systemic, intravenous HD-MTX in breast cancer patients with~     leptomeningeal metastasis with or without brain parenchymal metastasis.~   "
87433|NCT02422628|"~     Correlation of epithelial growth factor receptor mutation in blood of lung cancer patient and~     clinical outcome.~   "
87434|NCT02422615|"~     This is a multi-center, randomized, double-blinded, placebo controlled trial in men and~     post-menopausal women with advanced breast cancer.~   "
87435|NCT02422602|"~     This study is multicentric, single-blind, and interventionnal with a randomization into two~     parallel arm, between a standard of care information and an additionnal information of the~     patient, with a 12 month follow up.~      The aim of this study is to evaluate the effectiveness of a personalized information programm~     versus information provided from standard of care in patients taking Xarelto for Stroke~     Prevention in Atrial Fibrillation.~   "
87436|NCT02422589|"~     The purpose of this study is to evaluate the potential inhibitory effects of ceritinib on the~     CYP3A4- and CYP2C9-mediated metabolism of the probe drugs midazolam and warfarin,~     respectively, when administered simultaneously as a cocktail. The results obtained from this~     drug interaction study will provide guidance that will enable an update to the ceritinib~     labeling and will help guide recommendations for administration of co-medications in future~     clinical trials.~   "
87439|NCT02422550|"~     Magnetic resonance imaging (MRI) is currently one of the standard diagnostic imaging methods~     used to diagnose tumor stage before treatment in Radiology Oncology Department. It is also~     used to check responses to radiation after treatment. However, MRI isn't traditionally used~     in planning for radiation treatment or in checking treated tumor and tissue changes during~     radiation treatment. The goal is to find out the possible benefits of MRI imaging techniques~     in these settings of radiation treatment. Participating in this study would NOT change the~     current treatment plans, this will allow the investigators to use the MRI methods in research~     and future patient care.~   "
87440|NCT02422537|"~     During this project the effect of 3 different bran-based dietary platforms on the~     fermentation on a readily fermentable substrate will be investigated using stable isotope~     techniques.~   "
87441|NCT02422524|"~     This is a Phase 1, single dose (200 mg), open-label, sequential group study comparing the~     pharmacokinetics and safety of PA-824 in subjects with mild, moderate, and severe hepatic~     impairment to matched, non-hepatically impaired subjects. There will be approximately 36~     total subjects, adult males and females, 18 to 70 years of age, inclusive. The study will be~     conducted at 1 VTEU site, study duration is approximately 15 months, and subject~     participation duration is approximately 5 weeks (including screening). Primary objective: To~     evaluate the pharmacokinetics of a single oral dose of PA-824 in subjects with mild,~     moderate, and severe hepatic impairment (as assessed by Child-Pugh score), relative to~     matched non-hepatically impaired subjects. Secondary objective: To evaluate the safety of a~     single oral dose of PA-824 in subjects with mild, moderate, and severe hepatic impairment (as~     assessed by Child-Pugh score), relative to matched non-hepatically impaired subjects.~   "
87442|NCT02422511|"~     The Genomic Sequencing for Childhood Risk and Newborn Illness (the BabySeq Project) is a~     research study exploring the use of genomic sequencing in newborns. The National Institutes~     of Health is funding this study.~      The investigators will enroll 240 healthy infants and their parents from the Brigham and~     Women's Hospital (BWH) Well Newborn Nursery and 240 sick infants and their parents at Boston~     Children's Hospital (BCH) or the BWH Neonatal Intensive Care Unit (NICU). A small blood~     sample will be collected from each infant and genome sequencing may be performed. Six weeks~     later, results are returned and explained. Over 12 months the investigators are studying the~     experiences of parents and pediatricians of infants who receive sequencing to help understand~     how best to use genomics in pediatric care.~   "
87443|NCT02422498|"~     The study is being done to find out if the results of a pre-treatment biopsy can predict~     response to cisplatin and radiation treatment for patients with metastatic or recurrent~     triple negative breast cancer.~   "
87444|NCT02422485|"~     This is a multi-center, open label, pilot futility clinical trial of the safety,~     tolerability, pharmacodynamics and preliminary efficacy of oral salsalate in up to 10~     patients with PSP.~   "
87445|NCT02422472|"~     The purpose of this study is to compare ultrasound guided peripheral IV placement with and~     without the use of a guidewire. Patients in the Emergency Department with difficult~     peripheral IV access (as defined by 2 failed attempts by nursing staff) will be consented and~     randomized to standard ultrasound guided peripheral IV placement or ultrasound guided~     peripheral IV placement with modified seldinger technique using a guidewire.~   "
87446|NCT02422459|"~     The purpose of this study is to determine whether the combination of self-management support,~     pain science education, and individualized, goal-oriented exercises helps people with chronic~     pain to increase their function.~   "
87447|NCT02422446|"~     This pilot trial seeks to obtain preliminary data on the effects of eicosapentaenoic acid~     (EPA) (4g/d) on endothelial function measured via endopat2000 after 12 weeks of intervention~     among adults with elevated triglycerides and type 2 diabetes.~   "
87448|NCT02422433|"~     The purpose of this research is to test the feasibility, sensitivity, and specificity of the~     marking Optical Frequency Domain Imaging (OFDI) capsule for diagnosing Barrett's Esophagus~     (BE).~   "
87449|NCT02422420|"~     The objective of this study is to test whether two different participant financial incentive~     structures are more effective and cost effective than minimal financial incentives in~     increasing weight loss among Minnesota Medicaid beneficiaries at high risk of developing~     diabetes. The incentives are tied to participation and weight loss in the evidence-based~     group-delivered YMCA diabetes prevention program (Y-DPP). The Investigators will conduct a~     group randomized trial that includes up to 150 Y-DPP classes of 10-15 participants per class~     for up to 1500 Medicaid beneficiaries participating in the Y-DPP classes. This approach, if~     successful, will (a) improve weight loss. diabetes risk, and improve cardiovascular risk~     among Medicaid beneficiaries at risk for developing diabetes and other chronic conditions,~     (b) demonstrate that prevention of chronic disease risk factors using patient incentives is~     cost-effective, and (c) provide a patient incentive model that can be widely used among~     Medicaid beneficiaries at risk for developing diabetes.~   "
87450|NCT02422407|"~     The main objective of the study is to characterize the gene expression in immune and~     epithelial cells in salivary gland biopsy samples and blood of pSS (primary Sjögren's~     syndrome) and non-pSS participants including healthy volunteers.~   "
87451|NCT02422394|"~     Inherited thrombocytopenias are a heterogeneous group of disorders characterized by a reduced~     number of blood platelets and a consequent bleeding tendency that ranges from mild to~     life-threatening. Thrombocytopenia is caused by genetic mutations and therefore is present~     throughout patients' life and can be transmitted to the progeny. Some patients with severely~     reduced platelet count present spontaneous bleedings, which represent a major clinical~     problem: in fact, bleeding diathesis exposes these subjects to the risk of severe~     hemorrhages, affects their quality of life and often requires hospitalization and/or~     transfusions. Conversely, other patients with inherited thrombocytopenias have absent or mild~     spontaneous bleeding tendency. However, even these patients are at risk of major bleedings on~     the occasion of surgery or other invasive procedures. Therefore, the potential for~     hemorrhages on the occasion of invasive procedures represent a clinical problem for all~     patients affected by inherited thrombocytopenias.~      Eltrombopag is a drug, available in tablets, which stimulates the production of platelets by~     the bone marrow. A previous study demonstrated that a short course of eltrombopag was~     effective in increasing platelet count in most patients with the MYH9-related disease~     (MYH9-RD), one form of inherited thrombocytopenia. Eltrombopag was given for 3 to 6 weeks to~     12 patients with MYH9-RD and platelet counts lower than 50 x10e9/L. Eleven patients responded~     to the drug and 8 of them obtained platelet counts higher than 100 x109/L or three times the~     baseline value. Remission of spontaneous bleeding was achieved by 8 of 10 patients and~     treatment was well tolerated in all the cases. Based on these findings, short-term~     eltrombopag courses have been successfully used for preparing for major surgery two patients~     with MYH9-RD and less than 20 x10e9 platelets/L.~      The present study has two main objectives.~      - To verify if eltrombopag is effective in transiently increasing platelet count over 100 x~     109/L and abolish bleeding tendency in patients with different forms of inherited~     thrombocytopenia.~      To this end, eltrombopag will be given for 3-6 weeks to patients with different forms of~     inherited thrombocytopenia. Eltrombopag will be administered at the dosage of 50 mg/day for 3~     weeks. After 3 weeks of treatment, the patients who will obtain a platelet count higher than~     100 x10e9/L will stop therapy. The patients who will achieve a platelet count lower than 100~     x10e9/L will be treated with eltrombopag at a higher dosage (75 mg/day) for 3 additional~     weeks. This treatment schedule is called Phase 1 of the study.~      If the study will achieve this goal, short-term eltrombopag could be potentially used in the~     future to prepare these patients for surgery or other invasive procedures~      - To verify if eltrombopag can be used to stably reduce spontaneous bleeding tendency for~     long periods of time in patients with clinically significant spontaneous bleedings.~      To this end, patients with clinically significant spontaneous bleedings and who had their~     bleeding tendency reduced during the Phase 1 of the study without severe side effects, will~     be admitted to the Phase 2 of the study. During the Phase 2, patients will be treated with~     eltrombopag for 16 weeks. In order to determine the lowest dose of eltrombopag that is able~     to reduce or abolish their bleeding tendency, patients will start treatment with eltrombopag~     25 mg/day for 4 weeks. Then, every 4 weeks, patients will be re-evaluated and the dosage of~     eltrombopag will be adjusted according to the bleeding tendency of the 7 days before~     evaluation. The dosages of eltrombopag that can be used in the Phase 2 range from 12.5 to 75~     mg/day.~      Other objectives of the study are:~        -  to evaluate safety and tolerability of Eltrombopag in patients with inherited~          thrombocytopenias.~        -  to identify the dosages of Eltrombopag required to obtain the objectives of Phases 1 and~          2.~        -  to study the effect of treatment on some laboratory parameters related to platelet~          production and function.~      All patients will be undergo a follow-up visit 30 days after completion of treatment.~      Patients will be treated as outpatients.~      The evaluation of patients at enrollment includes: medical history; physical examination;~     peripheral blood examinations to count blood cells, to examine blood cells by microscope, to~     measure some parameters related to liver/kidney function and platelet production; standard~     urine analysis; ophthalmic assessment. Studies for dose adjustment includes the same~     examinations performed at enrollment with the exception of ophthalmic assessment. Evaluation~     of patients at the end of the Phases 1 or 2 and 30 days after the end of treatment includes~     the same examinations performed at enrollment: moreover, in patients who will obtain a~     platelet count higher than 100 x10e9/L, the in vitro platelet function will be studied.~   "
87452|NCT02422381|"~     This is a study for patients with previously-treated advanced non-small cell lung cancer~     (NSCLC). The study will evaluate the safety of adding an investigational drug, MK-3475 to~     standard treatment with gemcitabine. The study will also try to identify the best dose of~     MK-3475 to give in combination with gemcitabine.~   "
87453|NCT02422368|"~     ASTED (Antioxidant Supplements for TED) trial is an investigator-initiated, randomized,~     triple masked, clinical trial of a selected combination of vitamins and minerals versus~     placebo in patients with moderate to severe thyroid eye disease. The trial has a parallel-arm~     design.~   "
87454|NCT02422355|"~     In comparison to previous implants, the Femoral neck system (FNS) is an approved implant by~     the competent authorities (CE mark). It is designated to stabilize medial femoral neck~     fractures in a minimal invasive technique. The implant combines an angular stable device with~     screw in screw technology for rotational stability. Therefore the purpose of this focused~     registry is to investigate how the newly developed and approved implant called FNS is~     performing clinically and radiologically in terms of surgical technique, intra- and~     postoperative complications and short term outcome.~   "
87457|NCT02422316|"~     Background:~      Only around 20% of all patients seen in hospital with suspected Acute Coronary Syndrome will~     have Acute Myocardial Infarction. However, several studies indicate that patients where ACS~     had been excluded by conventional methods sustain a higher cardiac morbidity and mortality~     than the background population. Not all of these patients can be identified by traditional~     risk factors such as cholesterol, hypertension, and diabetes or with conventional methods~     such as ECG, troponin and clinical symptoms. Non-Contrast Cardiac-CT measures the amount of~     calcification in the coronary arteries and might be a useful addition in predicting future~     cardiac events in this patient group. The aim of this study is through a double-blinded study~     to determine whether non-contrast CT scan with calcium score can be used to identify patients~     at increased risk of death and cardiac event within the following 12 months after an acute~     admission where troponin measurements were normal.~      Methods:~      The study will investigate patients with suspected Acute Coronary syndrome who have been~     examined and subsequently sent home from an emergency- or cardiology department without ACS~     or another obvious explanation. 750 patients, age 30-70 years who are included in the study:~     Identification of risk factors in non-cardiac chest pain patients will be offered a~     non-contrast CT scan with calcium score within 14 days after the hospital contact. The~     participants will be included in a 12 months follow up, where the result of the calcium score~     is not revealed neither for the patient nor the investigator. After 12 months the results of~     the scan is compared with the rate of cardiac events. This project is a multicenter study and~     recruits patients from 6 emergency - and cardiology departments in the region of Southern~     Denmark.~      The study commences at September 2014 and results of this project are expected to contribute~     to the risk stratification of Non-cardiac chest pain patients.~   "
87458|NCT02422303|"~     Ketamine has been shown to have an antidepressant effect when given intravenously in doses of~     2mg/kg. Ketamine is used as a standard induction drug during general anesthesia. It is known~     in this instance to decrease postoperative pain. No one has studied whether or not ketamine~     when given in doses used during general anesthesia (0.5mg/kg intravenous) has an~     antidepressant effect on surgical patients who suffer from depression. The study is designed~     to determine whether or not a small dose of ketamine when given at the induction of~     anesthesia could have an antidepressant effect on surgical patients with depression.~   "
87459|NCT02422290|"~     This pilot study is proposed to determine the acceptability, feasibility and potential~     efficacy of ketamine, a medication that modulates glutamate in the brain, as a rapid~     treatment for obsessive-compulsive disorder (OCD) symptoms in adolescents and young adults~     with OCD. This study will recruit 6 youth (ages 14-22) who are diagnosed with clinically~     significant OCD and have failed at least one adequate trial of a Serotonin Reuptake Inhibitor~     (SRI) medication and a course of Cognitive-Behavioral Therapy (CBT) (unless unable to access~     or tolerate) for OCD in the past. Participants will receive a single infusion of intravenous~     ketamine and be assessed at regular intervals post-infusion for up to 14 days. At the end of~     the 14-day treatment phase, all participants will be offered three months of open treatment~     for OCD with medication and/or CBT.~   "
87460|NCT02422277|"~     The aim of this clinical trial is to evaluate the role of extracorporeal low-intensity shock~     wave therapy in penile rehabilitation post nerve sparing radical cysto-prostatectomy.~   "
87461|NCT02422264|"~     The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals'~     Infanrix hexa, given in the primary vaccination schedule to infants born to pregnant women~     who participated in study 116945 [DTPA (BOOSTRIX)-047]. This study will help us evaluate if~     the presence of transplacentally transferred maternal antibodies interfere with the immune~     response to primary vaccination with Infanrix hexa and a co-administered pneumococcal~     conjugate vaccine given as a part of this study in infants.~   "
87462|NCT02422251|"~     The aim of the project is to compare the biomechanics of three different bearing designs used~     in total knee replacement (TKR) implants. The bearing is the part in the middle of the knee~     implant that allows the metal tray attached to the shin bone (tibia) to move in relation to~     the metal part attached to the thigh bone (femur) and is usually made of plastic (high~     density polyethylene). There will be three different bearing types in the study, which all~     give different movements. This study will see which bearing is most like a natural knee and~     so which design gives the best function and feeling to patients with a TKR. 90 TKR patients~     from the Golden Jubilee National Hospital will be recruited and randomised to receive one of~     the three study bearings (30 in each group). In addition, a control group of 30 healthy~     individuals of similar age will be recruited for comparison. Before surgery and at 4 to 8~     weeks and 1 year after their operation patients will attend biomechanical assessment sessions~     at the University of Strathclyde. The control group will attend the assessment session only~     once. In each of these sessions they will carry out a number of everyday tasks such as~     walking, moving from sitting to standing and going up and down stairs. These tasks will be~     measured using motion capture techniques. Reflective markers placed on each participant will~     be tracked by cameras so that their movements can be recorded. Force plates in the floor will~     record the forces during the tasks.~      Movement and force data will be analysed to see if any differences exist between the groups~     and show which bearing gives the most natural movement.~   "
87463|NCT02422238|"~     The aim of the present prospective NAFLD cohort study (with biobank), of obese subjects with~     proven NAFLD based on liver biopsy and/or MRI, is to study factors contributing to the~     development of NASH in patients with simple steatosis and to identify and validate~     non-invasive markers for the diagnosis of NASH.~   "
87464|NCT02422225|"~     The primary objective of this study is to investigate whether the dual transcranial direct~     current stimulation(tDCS) improves the swallowing function of stroke patients.~   "
87465|NCT02422212|"~     Introduction: According to the National Health and Nutrition Examination Survey 2009-2010, 78~     million American adults are obese. Bariatric surgery can provide for a sustained long-term~     weight loss and the metabolic change caused by the surgery seems to be the main cause of this~     loss. Cross-sectional, prospective and experimental studies, carried out during the~     post-operative period of Roux-en-Y Gastric Bypass surgery (RYGBP) have shown an increase of~     over 200% in energy expenditure after meals Diet-induced Thermogenesis (DIT), a specific~     component of energy expenditure) when compared with obese patients. However, despite this~     metabolic improvement, 20-50% of the patients can suffer weight regain about 2 years after~     surgery. So one question whether such metabolic benefits remain active following~     post-operative weight regain, or if the disappearance or decrease of these metabolic benefits~     may be seen as causes of this weight regain.~      Objective:To evaluate whether there are DIT differences between patients who maintained~     weight loss and those who regained weight in the late postoperative (postop) period of RYGBP~     and those who continue with preoperative (preop) obesity.~   "
87604|NCT02420405|"~     The objective of the study was to compare the value of routine gene testing and~     next-generation sequencing (NGS) in detecting gene mutations of small specimens obtained by~     endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA) and get the knowledge~     of how many EBUS-TBNA samples were adequate for NGS.~   "
87466|NCT02422199|"~     Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This~     study is a randomized, multi-center, multinational, open-label, active-controlled, parallel~     design study of the combination of pyrotinib plus capecitabine versus the combination of~     lapatinib plus capecitabine in HER2+ MBC patients who have prior received anthracyclin,~     taxane or trastuzumab. Patients will be stratified by weather have prior use of trastuzumab~     and randomized in a 1:1 ratio to one of the following treatment arms:~        -  Arm A: pyrotinib (400 mg once daily) + capecitabine (1000 mg/m^2 twice daily)~        -  Arm B: lapatinib (1250 mg once daily) + capecitabine (1000 mg/m^2 twice daily) Patients~          will receive either arm of therapy until the occurrence of death, disease progression,~          unacceptable toxicity, or other specified withdrawal criterion.~   "
87467|NCT02422186|"~     The purpose of this study is to evaluate the efficacy and safety of switching elderly~     participants with treatment-resistant depression (TRD) from a prior antidepressant treatment~     (to which they have not responded) to either intranasal esketamine plus a new oral~     antidepressant or switching to a new oral antidepressant plus intranasal placebo.~   "
87468|NCT02422173|"~     Transcranial direct current stimulation (tDCS) has shown promising results in the modulation~     of cortical excitability and the promotion of neuronal plasticity after stroke. The purpose~     of this study was to compare the effectiveness of three different montages of tDCS (anodal,~     cathodal and bilateral) in reducing the risk of falls and recovery of lower limb function in~     acute stroke patients.~   "
87469|NCT02422160|"~     The investigators have developed an image analysis method that can predict the likelihood~     that a patient with age related macular degeneration (AMD) will progress within 1 year, based~     on computerized analysis of optical coherence tomography (OCT) images that are routinely~     acquired in clinical practice on each patient visit to the ophthalmologist. The~     investigators' goal is to evaluate whether this method will improve the ability to detect AMD~     earlier and improve visual outcomes in AMD patients by assigning patient risk categories and~     having patients come back for follow up based on those categories.~   "
87470|NCT02422147|"~     This is a registry that will maintain prospective data on the clinical outcomes of all~     patients with pancreatic cyst lesions who undergo EUS-guided alcohol ablation.~   "
87471|NCT02422134|"~     It was proven that the Cytokine granulocyte-Macrophage clony stimulating factor had been~     found naturally in reproductive tract so our target is to test its effect if added to embryo~     transfer medium.~   "
87472|NCT02422121|"~     The study will investigate the effect of treatment with RNS60 for 21 days. Subjects' FEV1~     will be measured after an inhaled allergen challenge at baseline and again after 21 days of~     treatment.~   "
87473|NCT02422108|"~     The receptor activator of NF-kB ligand (RANKL) system is considered important for bone~     homeostasis and comprises three important factors. RANKL exist in three isoforms but the~     predominant function is mediated by the transmembrane ligand that binds to a specific~     receptor (receptor activator of NF-KB (RANK)) on a neighbour cell that subsequently activates~     NFKB and regulates cell cycle OPG is an endogenous secreted protein that binds RANKL and~     inhibits its signalling.~      Thus, the RANK/RANKL system is vital for activation of the bone resorbing cells~     (osteoclasts). In bone the bone synthesizing cells (osteoblasts) express RANKL that signals~     to RANK on the immature osteoclasts. This induces proliferation and activation of the cells~     they start to proliferate and resorp bone. OPG is produced by somatic cells in the bone and~     this production is regulated by sex hormones, TGF-B and various other substances. Today a~     human made recombinant antibody against RANKL, Denosumab is used to treat osteoporosis as it~     inhibits RANKL signalling and thus causes less bone resorption in humans.~      RANKL, RANK and OPG are expressed in the testis and this pathway appears to be a novel~     regulator of germ cell proliferation. Decreased semen quality is a major factor of male~     infertility. Semen quality is a measure of the ability of the sperm to accomplish~     fertilization. Evaluation of male fertility potential is today basically conducted through~     semen analysis. There is no treatment for men with no sperm in the ejaculate and there exist~     no drug that can increase sperm counts.Therefore, drugs that can lower RANKL~     expression/activity for instance an antibody against RANKL such as Denosumab may be used for~     this new indication: A new treatment option of infertile men with impaired semen quality.~   "
87474|NCT02422095|"~     This registry is developed to assess the outcomes of patients undergoing EUS of pancreatic~     cyst lesions as is provides data that will enable quality control of the examination~     performed.~   "
87475|NCT02422082|"~     Lactobacillus reuteri (L. reuteri) has been widely studied in clinical trials and has~     probiotic, health-promoting effects in both adults and children, and is safe for human~     consumption. Animal models indicate that treatment with L. reuteri has positive effects on~     bone metabolism and bone density. In other animal models of diabetes and the metabolic~     syndrome, positive effects on blood glucose and weight have been reported. The present~     double-blind, placebo-controlled, randomized study is designed to investigate if dietary~     supplementation with L. reuteri twice daily for 12 months has any effect on bone density,~     body composition, inflammation, or metabolic and endocrine markers in elderly women with~     osteopenia.~   "
87476|NCT02422069|"~     This observational study will provide an opportunity to document local patterns of~     susceptibility, patient profile, and usefulness of screening in postmenopausal patients~     coming to gynecology outpatient clinics in Pakistan. This will also capture the initial~     management of PMO in diagnosed patients. The information gathered will serve as a foundation~     for developing national guidelines on screening and management of PMO in Pakistan.~   "
87477|NCT02422056|"~     Randomized study evaluating the role of tranexamic acid in reducing intraoperative bleeding~     in palatoplasty.~   "
87478|NCT02422043|"~     The patient education programs (TPEs) for the type 1 diabetic adolescents are designed to~     make the teenager to self manage their disease and its treatment. Based on social cognitive~     theory Bandura, the effects of educational activities for TVE should lead to the~     strengthening of self-efficacy, coupled with other socio-cognitive factors favoring adherence~     of teenager and a better quality of life. However, socio-cognitive determinants and~     mechanisms to achieve this, implemented by adolescents during and after the ETP program, are~     not sufficiently documented.~   "
87479|NCT02422030|"~     The purpose of this study is to evaluate the pharmacokinetic interaction between Atorvastatin~     and Fenofibric acid.~   "
87605|NCT02420392|"~     To investigate the effect of dapagliflozin on the incretin sensitivity of the pancreatic beta~     cell.~   "
87480|NCT02422017|"~     Background: Venous Leg ulcers are a frequent pathology in dermatology and complex in their~     management. At the origin of high health costs and strong repercussions on quality of life~     for patients, they require long management and may be subject to possible complications.~      In spite of appropriate treatment, 50-60% of these ulcers are not healed at 24 weeks.~      Purpose: Topical beta adrenergic antagonists have shown efficacy in wound healing. The~     purpose of this study is to evaluate the efficacy and safety of treatment of chronic venous~     ulcers with topical timolol.~   "
87481|NCT02422004|"~     The overall aim of this project is to investigate the healing processes of human tendon after~     suturing a ruptured Achilles tendon, and more specifically to determine the optimal loading~     pattern of the tendon during the rehabilitation period to ensure complete and good recovery~     of tendon structure and function. The investigators hypothesize that restricting early weight~     bearing and only allowing for passive stretching in the early phase of tendon healing will~     ensure better tissue regeneration and thereby prevent chronic tendon elongation and improve~     tendon tissue recovery and the clinical outcome.~   "
87482|NCT02421991|"~     The purpose of this study is to demonstrate that Acceptance and Commitment Therapy's (ACT)~     implementation outcomes are at least as good as those of traditional cognitive behavioral~     therapy (CBT).~   "
87483|NCT02421978|"~     The purpose of this study is to try and provide data linking the impact of increased~     inflammatory cytokines as a result of chemotherapy and their relationship with increased~     levels of CNS glutamate and related behavioral and cognitive consequences in breast cancer~     patients. The investigators will use neuropsychiatric assessments, blood sampling and~     Magnetic Resonance Spectroscopy (MRS) to collect study data.~   "
87484|NCT02421965|"~     The study is a three year research project whose aims are to evaluate the willingness of~     individuals with serious mental illness to initiate the two illness self-management~     interventions- WRAP or FOCUS, to examine and compare participant engagement, satisfaction,~     and outcomes (symptoms, recovery, quality of life) in the two interventions.~   "
87485|NCT02421952|"~     Pediatric research in the management of nausea has been limited by the absence of a reliable~     method to quantify the intensity of this subjective symptom. In adults, the visual analog~     scale (VAS) is an accurate tool, but this has not been shown to be reliable in young~     children. By default the most common objective outcome measure used in pediatric studies has~     been the incidence and number of emetic episodes. This measure, however, correlates poorly~     with the somatic subjective symptom of nausea.~   "
87486|NCT02421939|"~     The purpose of this study is to determine the clinical benefit of ASP2215 therapy in patients~     with FMS-like tyrosine kinase (FLT3) mutated acute myeloid leukemia (AML) who are refractory~     to or have relapsed after first-line AML therapy as shown with overall survival (OS) compared~     to salvage chemotherapy, and to determine the efficacy of ASP2215 therapy as assessed by the~     rate of complete remission and complete remission with partial hematological recovery~     (CR/CRh) in these patients.~      This study will also determine the overall efficacy in event-free survival (EFS) and complete~     remission (CR) rate of ASP2215 compared to salvage chemotherapy.~   "
87487|NCT02421926|"~     This study is an extension study (prospective observational study) of 'IDEAL' study (A Study~     to Evaluate Efficacy and Safety of Imatinib (Glinib) 600mg/day depending on Early Molecular~     Response in Newly Diagnosed Patients with Chronic Myeloid Leukemia in Chronic Phase,~     NCT02204722) to evaluate the duration of treatment response, disease progression, and~     survival status up to 5 years after the inclusion.~   "
87488|NCT02421913|"~     Background: The use of low-dose continuous infusion of S(+)-ketamine combined with~     target-controlled intravenous anesthesia with remifentanil and propofol may be related to the~     control of postoperative pain and of opioid-induced hyperalgesia. The present study aimed to~     evaluate the efficacy of continuous infusion of S(+)-ketamine given intraoperatively in the~     control of postoperative pain compared to placebo.~   "
87489|NCT02421900|"~     The purpose of this study is 1) to characterize T-cell response in patients with atrial~     fibrillation, and 2) to analyze the changes of T-cell response after radio-frequency catheter~     ablation of atrial fibrillation. First, immune-phenotyping and cytokine profiling of T cells~     from patients with atrial fibrillation will performed. Next the difference of T-cell immunity~     among various type of atrial fibrillation patients will be analyzed. Finally the changes of~     T-cell response and cytokines after radio-frequency catheter ablation of atrial fibrillation~     will be assessed.~   "
87490|NCT02421887|"~     The objective of the Males, Antioxidants, and Infertility (MOXI) Trial is to examine whether~     treatment of infertile males with an antioxidant formulation improves male fertility. The~     central hypothesis is that treatment of infertile males with antioxidants will improve sperm~     structure and function, resulting in higher fertilization rates and improved embryo~     development, leading to higher pregnancy and live birth rates. Findings from this research~     will be significant in that they will likely lead to an effective, non-hormonal treatment~     modality for male infertility. An effective treatment for men would also reduce the treatment~     burden on the female partner, lower costs, and provide effective alternatives to couples with~     religious or ethical contraindications to ART (Assisted Reproductive Technology). If~     antioxidants do not improve pregnancy rates, but do improve sperm motility and DNA integrity,~     they could allow for couples with male factor infertility to use less intensive therapies~     such as intrauterine insemination. Male fertility specialists currently prescribe~     antioxidants based on the limited data supporting their use. A negative finding, lack of any~     benefit, would also alter current treatment of infertile males.~   "
87498|NCT02421783|"~     Non-celiac gluten sensitivity (NCGS) or 'wheat sensitivity' (NCWS) is included in the~     spectrum of gluten-related disorders. No data are available on the prevalence of low bone~     mass density (BMD) in NCWS. Our study aims to evaluate the prevalence of low BMD in NCWS~     patients and search for correlations with other clinical characteristics.~      This prospective observation study will include 90 NCWS patients with irritable bowel~     syndrome (IBS)-like symptoms, 90 IBS and 90 celiac controls. Patients will be recruited at~     the Internal Medicine and at the Gastroenterology Units of the University of Palermo.~     Elimination diet and double-blind placebo controlled (DBPC) wheat challenge proved the NCWS~     diagnosis. All subjects underwent BMD assessment by Dual Energy X-Ray Absorptiometry (DXA),~     duodenal histology, Human Leukocyte Antigen (HLA) DQ typing, body mass index (BMI) evaluation~     and assessment for daily calcium intake.~   "
87491|NCT02421874|"~     The purpose of this Phase II Small Business Technology Transfer (STTR) project is to complete~     development and evaluate usability and effectiveness of the Wraparound Team Monitoring System~     (Wrap-TMS), a web-based, electronic behavioral health information system (EBHIS) for the most~     widely implemented care coordination model in children's behavioral health, the wraparound~     process. Though wraparound is now considered evidence-based, implementation in the real~     world often fails to conform to standards of fidelity and/or use objective data to guide~     management, supervision, and clinical decision making. Availability of such a system will~     support efficiency, implementation quality and fidelity, and outcomes for youths enrolled in~     wraparound. Wrap-TMS features functionality for data entry, management, and basic reporting~     for the full array of data and information elements needed to manage an integrated care~     coordination initiative for youths with serious emotional and behavioral disorder (SEBD). In~     light of our success in Phase I, subsequent partnerships with federal agencies, and inquiries~     of interest from several states and over 20 provider and managed care organizations, in this~     Phase II STTR the investigators will complete development of Wrap-TMS, followed by a~     randomized controlled effectiveness study comparing n=25 wraparound facilitators who use~     Wrap-TMS serving n=100 families to 25 non-user facilitators serving 100 families on~     practitioner, implementation, and youth/family outcomes. The evaluation will test two primary~     hypotheses:~        1. Compared to facilitators in the control group, wraparound facilitators trained to use~          Wrap-TMS will demonstrate (a) greater use of data and feedback in service delivery; (b)~          greater fidelity to the wraparound process; (c) higher self-reported teamwork, working~          alliance, and satisfaction with the intervention; and (d) more positive attitudes toward~          standardized assessment.~        2. Compared to the control group, parents of youths receiving services from facilitators~          trained to use TMS will report (a) greater goal clarity, (b) more data collection and~          use (c) greater satisfaction with services and progress, (d) better fidelity to~          wraparound, (e) more effective team functioning, (f) greater treatment alliance, and (f)~          better youth outcomes including greater progress and improved symptoms and functioning.~   "
87492|NCT02421861|"~     The aims of this study are to (1) test the benefits of a non-pharmacologic anxiety management~     approach with patients who are critically ill and/or traumatically injured during intensive~     care hospitalization and (2) test whether this approach reduces anxiety and improves~     engagement in rehabilitation therapies, shortens duration of hospitalization, and improves~     psychological and quality of life outcomes.~   "
87493|NCT02421848|"~     Malnutrition due to liver disease is common, however, their detection is difficult. The~     parameters used for nutritional assessment in clinical practice have limited use in this~     patient population.~      From this perspective, this study proposes to develop predictive equations for body~     composition for electrical bioimpedance (BIA) in cirrhotic patients. Besides being a fast and~     risk free, the BIA offers the additional advantage of low cost compared to other methods that~     assess body composition (BC).~      Will be selected patients male with liver cirrhosis (n = 112) of the Liver Transplant Clinic~     of the Hospital of the Clinicas, Faculty of Medicine, University of São Paulo.~      This pioneering study is of great clinical importance because malnutrition is a relevant~     factor in the prognosis of liver disease and there is not efficient method in clinical~     practice to properly assess the body composition in this population.~   "
87494|NCT02421835|"~     Hypertension affects about 30% of the United Kingdom population and is causally implicated in~     the aetiology of renal disease, cardiovascular disease and stroke. Ageing, obesity, a poor~     diet and low levels of physical activity are all risk factors. Studies have shown that~     adherence to a Mediterranean diet is protective against hypertension and its associated~     morbidities; olive oil is believed to be a key beneficially bioactive component of that diet.~     As a source of lipids olive oil is an unremarkable blend of monounsaturated, polyunsaturated~     and saturated fatty acids; it is however rich in phenolic compounds, principally oleuropein~     and hydroxytyrosol, which may be of benefit to health. A recent randomised intervention trial~     in predominantly hypertensive volunteers showed that adherence to a Mediterranean diet~     supplemented with extra virgin olive oil, reduced blood pressure and other measures of~     cardiovascular disease risk. Olive phenolics can be extracted cheaply from the waste products~     of olive oil manufacture, such as the plant leaf and these are used as dietary supplements.~     In intervention studies in hypertensive or borderline hypertensive patients, olive leaf~     extract consumption has been shown to reduce blood pressure.~      Another intervention with established efficacy for improving blood pressure is to increase~     physical activity. The 'Start Active, Stay Active', Chief Medical Officers report on physical~     activity recommends that adults achieve 150 minutes of moderate intensity physical activity~     per week, while data in that report suggest that fewer than 40% of adult men and 30% of adult~     women achieve these targets. Adherence to the physical activity guidelines may in fact be~     much worse in sub-sections of the population at higher risk of hypertension.~      From a public health perspective, holistic guidelines for the prevention of hypertension, or~     its early diagnosis and management, based around a healthy diet and lifestyle are preferable~     to pharmaceutical intervention. Lifestyle interventions are economically favourable and they~     come with fewer side effects and perhaps wider health benefits than antihypertensive drugs.~      The aim of the study is to evidence the synergistic benefits of consuming plant (and~     specifically olive) phenolics alongside achieving the recommended guidelines for physical~     activity in individuals with elevated blood pressure.~   "
87495|NCT02421822|"~     The purpose of this study is to test the Fitwits office tool and games with 6-9 year old~     children and their parents to: 1) assist parent-child dyad with correct BMI status~     identification and understanding; 2) address nutrition, portion size, and activity cues; and,~     3) track BMI trajectory over 12-month period.~   "
87496|NCT02421809|"~     Non-celiac gluten sensitivity (NCGS) or 'wheat sensitivity' (NCWS) is included in the~     spectrum of gluten-related disorders. No data are available on the prevalence of oral lesions~     in NCWS. Our study aims to evaluate the prevalence of oral lesions in NCWS patients and~     search for correlations with other clinical characteristics. This prospective observation~     study will include 90 NCWS patients with irritable bowel syndrome (IBS)- like symptoms, 90~     IBS and 90 celiac controls. Patients will be recruited at the Internal Medicine and at the~     Gastroenterology Units of the University of Palermo. Elimination diet and double-blind~     placebo controlled (DBPC) wheat challenge proved the NCWS diagnosis. All subjects underwent~     oral examination to assess the presence or not of oral soft and hard tissue lesions~     potentially associated to NCWS and CD.~   "
87497|NCT02421796|"~     Non-celiac gluten sensitivity (NCGS) or 'wheat sensitivity' (NCWS) is included in the~     spectrum of gluten-related disorders. No data are available on the prevalence of low bone~     mass density (BMD) in NCWS. Our study aims to evaluate the prevalence of malnutrition in NCWS~     patients and search for correlations with other clinical characteristics. This prospective~     observation study will include 90 NCWS patients with irritable bowel syndrome (IBS)-like~     symptoms, 90 IBS and 90 celiac controls. Patients will be recruited at the Internal Medicine~     and at the Gastroenterology Units of the University of Palermo. Elimination diet and~     double-blind placebo controlled (DBPC) wheat challenge proved the NCWS diagnosis. All~     subjects underwent nutritional parameters measurement, duodenal histology, Human Leucocyte~     Antigen (HLA) DQ typing and body mass index (BMI) evaluation.~   "
87519|NCT02421510|"~     This Phase 3 study is intended to demonstrate superiority of either Sotagliflozin high dose~     or low dose versus placebo on glycosylated hemoglobin A1C (A1C) reduction at Week 24 when~     used as an adjunct in adult patients with type 1 diabetes mellitus (T1D) who have inadequate~     glycemic control with insulin therapy.~   "
87606|NCT02420379|"~     This is an open-label study to assess the safety, tolerability, efficacy and pharmacokinetics~     of eteplirsen in patients with early stage Duchenne muscular dystrophy (DMD) who are amenable~     to exon 51 skipping.~   "
87499|NCT02421770|"~     Oral lichen planus (OLP) is a chronic inflammatory mucocutaneous disease characterized by~     outbreaks or flares. It affects 0.2-1.9% of the population. Although the etiology is unknown,~     the pathogenesis of OLP is known to involve an immune disorder, with epithelial damage caused~     by cytotoxic CD8 + lymphocytes. Clinically, the disease is characterized by different types~     of lesions - papular, reticular and in the form of plaques - that can alternate with erosive~     and/or ulcerative areas. A variety of treatments have been proposed for OLP: topical or~     systemic corticosteroids, cyclosporine, retinoids, azathioprine, tacrolimus, pimecrolimus,~     photochemotherapy and surgery. Patients with symptomatic OLP often require intensive therapy~     to reduce the signs and symptoms. The disease can produce considerable morbidity and alter~     patient quality of life, particularly in the presence of ulcerative lesions.~      There is no fully resolutive and effective treatment - the management strategy focusing on~     the use of drugs that counter tissue inflammation and the underlying immunological~     mechanisms. The main inconvenience of these treatments is represented by the side effects~     they usually produce.~   "
87500|NCT02421757|"~     This is a single-site, randomized, Single-blinded, placebo-controlled, trial of~     Transcutaneous Magnetic Stimulation (TCMS) for the treatment of lower back pain. TCMS will be~     applied locally to the back in the location of a patient's pain.~   "
87501|NCT02421744|"~     Our primary hypothesis is that a two weeks high-intensity task-oriented circuit training~     followed by a structured 3 months home exercise program would have higher benefits compared~     to a delayed-treatment group as control in people with multiple sclerosis and mild to~     moderate gait impairment.~      Our secondary hypothesis is that there could be retention of clinical gains in subjects that~     underwent TOCT plus structured 3 months home exercise program.~   "
87502|NCT02421731|"~     Gait disabilities affect personal activities and quality of life of progressive multiple~     sclerosis (MS) patients. A robot-driven gait orthosis allowing a more effective support of~     walking movements and imitation of a nearly normal gait pattern during treadmill training at~     a higher speed has been developed and recently introduced in clinical settings. However,~     until now few studies evaluated the effects of Robot-Assisted Gait Training (RAGT) in a group~     of stroke, spinal cord injury and MS subjects.~      In addition, the training-induced neural and biological changes potentially related to the~     mechanisms of recovery remain undefined.~      The primary aims of this study are:~      to test the feasibility of RAGT in a group of progressive severely disabled MS patients and~     to test the hypothesis that this intensive intervention could have higher benefit, compared~     with conventional therapy alone, in mobility improvement as assessed by the Timed 25 Foot~     Walk (T25FW)~      The secondary aims of this study are:~      to determine whether fatigue, Quality of life, balance and locomotor function are improved by~     RAGT; to determine whether gait training influences markers of plasticity including clinical~     and circulating biomarkers to search for a possible correlation between clinical outcomes and~     clinical and circulating biomarkers~   "
87503|NCT02421718|"~     Motive:~      In order to improve the treatment technique, a comprehensive follow-up program is needed to~     obtain all relevant patient, treatment and toxicity data from lung cancer patients.~      Goal:~      To set-up and maintain a database containing treatment results in terms of tumor control,~     side effects, complications and patient-reported quality of life.~      A standard database of patients receiving photon treatment will be created. These data are~     then linked to dose-volume data of radiotherapy, with the aim to build prediction models for~     both tumor control and toxicity after radio (chemo) therapy that can later be used for~     selecting patients for proton treatment.~   "
87504|NCT02421705|"~     Aim:~      More insight in pathogenesis of IBS and IBD. Samples are collected in context of an European~     research project.~   "
87505|NCT02421692|"~     Each year Medicare spends approximately $31.3 billion on 2.4 million skilled nursing facility~     (SNF) episodes of care. SNFs rely on interdisciplinary approaches to patient care to maximize~     rehabilitation potential for return to prior level of function and reduce the risk of adverse~     events in older adults. However despite a substantial increase in spending on SNF services~     and minimal change in complexity of the caseload, 68% of patients are below their~     pre-hospitalization level of function at discharge, 25% return to the community, and 18% are~     hospitalized. This may be partially explained by current SNF approaches to patient care which~     foster inactivity and participation in low intensity rehabilitation interventions~     (preliminary data). Both inactivity and low-intensity interventions may perpetuate further~     functional decline or impede maximal recovery. The serious implication of risk with~     functional decline is exemplified by studies which have shown declines in physical function~     can increase the risk of being re-hospitalized six-fold and may infer other long term effects~     such as increased risk for mortality, morbidity, and institutionalization. Muscle weakness,~     reduced cardiorespiratory reserve, and neuromuscular deficits have been attributed to this~     acute decline in function. However current rehabilitation strategies in SNFs do not promote~     adequate dose and mode of interventions to induce beneficial systemic adaptations, perhaps~     due to the lack of evidence on effective rehabilitation protocols for this medically-complex~     population. Therefore, the investigators have designed an rehabilitation program, which~     uniquely integrates principles of physiologic tissue overload with strengthening and~     functional interventions for greater gains in physical function. Data will be collected on~     the first cohort of patients who cycle through a SNF during Stage 1, in which usual care~     occurs (5 months). Then, staff training on progressive rehabilitation interventions will~     occur over 2 months. Finally, data will be collected on a second cohort of patients who cycle~     through a SNF during Stage 2, in which progressive rehabilitation is implemented by SNF staff~     (5 months). Given the high turnover of patients in SNFs (average length of stay ~21 days), 2~     different cohorts of patients will be studied and the analysis will consist of independent~     2-sample t-tests. During Stage 1 and 2, measures of physical function will be assessed on all~     eligible patients at admission and discharge from SNF. Therapists will be assessed on~     adherence to the protocol through documentation audits and use of on-site observational~     checklist. Acceptability of the intervention by the patients will be assessed by a patient~     satisfaction survey. Any adverse events will be obtained from the medical record and~     documented. The discharge location of all patients will be documented.~   "
87506|NCT02421679|"~     This is a 12-week, multicenter, open-label extension study to evaluate the safety and~     efficacy of TNX-102 SL tablet taken daily at bedtime in patients with Military-Related PTSD~     or related condition. Patients recruited into this trial are those who have successfully~     completed the double-blind study, TNX-CY-P201 (AtEase Study). Patients will not be made aware~     of the therapy they received during the double-blind study.~   "
87537|NCT02421276|"~     This study plans to learn more about Down syndrome. The investigators think there is a~     different level of the AIRE gene in individuals with Down syndrome. The investigators think~     that the AIRE gene level can provide more insight about depressed immune cell function in~     individuals with Down syndrome. Patients are being asked to be in this research study because~     the investigators want to see if their blood contains more of less of the AIRE gene.~   "
87607|NCT02420366|"~     A multi-center, retrospective study of cases of serious bacterial infections including~     complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP), Hospital Acquired~     Bacterial Pneumonia (HABP), Ventilator Acquired Bacterial Pneumonia (VABP), and/or bacteremia~     caused by Carbapenem-Resistant Enterobacteriaceae (CRE)~   "
87507|NCT02421666|"~     Asian Americans have the highest rates of chronic hepatitis B virus (HBV) infection (CHB) in~     the United States.Those with CHB often report that they feel well even though they are at~     high risk for complications. Because of the high incidence and prevalence of CHB, patients at~     high risk need to be tested every 6 to 12 months for early signs of liver problems.This study~     will answer critical questions for Asian Americans with CHB about improving timely testing.~     Using a randomization process, 500 of these patients will receive either the Patient~     Navigator plus Mobile Phone Text Messaging Intervention (PNMI) or standard care. At patients'~     entry into the study, 6 months, and 12 months, information will be collected.Patient~     navigators representing Asian cultures will receive a thorough HBV training. PNMI patients~     will receive three patient navigator led education sessions and text messages over mobile~     phone. Patients, patient advocates, physicians, and researchers of Center for Asian Health~     (CAH) will be active study partners.~      Patient Outcomes: The investigators expect to find better health outcomes and lower HBV~     health gaps, as measured by the number of patients:~        1. getting doctor-recommended tests at 6 and 12 months;~        2. getting doctor-recommended HBV care;~        3. improved HBV knowledge, a better quality of life, social support, and coping skills; and~        4. having fewer barriers and less anxiety.~   "
87508|NCT02421653|"~     In this study, two intervention strategies to address iodine deficiency and prevent iodine~     deficiency disorders in breast-fed weaning infants will be evaluated in a mild to moderate~     iodine-deficient population in Zamboanga del Norte, Philippines, Southeast Asia.~   "
87509|NCT02421640|"~     This is a Phase II trial to study the effectiveness and security of cisplatin concurrent~     chemoradiotherapy plus TIL versus cisplatin concurrent chemoradiotherapy only with IMRT in~     treating patients with locoregionally advanced high risk nasopharyngeal carcinoma.~   "
87510|NCT02421627|"~     To observe the safety and efficacy of moxibustion on diarrhea-predominant irritable bowel~     syndrome and evaluation by Magnetic Resonance Imaging (MRI).~   "
87511|NCT02421614|"~     This study aimed to investigate the effect of enteral feeding's macronutrient composition on~     inflammatory mediators, oxidative stress and outcomes in Intensive Care Unit (ICU) patients~     with acute respiratory failure. In this double-blind randomized control trial, 42 patients of~     both sexes and diagnosed with acute respiratory failure in ICU that receive enteral feeding,~     will be randomly assigned to three groups of 14 each. First Intervention group; high-protein~     low-carbohydrate diet with high olive oil, the second intervention group; high-protein~     low-carbohydrate diet with high sunflower oil and control; high-protein kitchen formula.~     Intravenous levels of uric acid, high sensitive C-Reactive Protein (hs-CRP), Interleukin 6~     (IL-6) and Total Antioxidant Capacity (TAC) measured at days 0 and 10. As well as, organ~     failure, duration of ventilation, length of ICU stay and mortality rates will be evaluated.~   "
87512|NCT02421601|"~     The purpose of this study is to evaluate the safety and efficacy of SI-6603(Condoliase) in~     patients with lumbar disc herniation.~   "
87513|NCT02421588|"~     Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate the~     activity and safety of PM01183 versus PLD or topotecan as control arm in patients with~     platinum-resistant ovarian cancer. PM01183 will be explored as single agent in the~     experimental arm (Arm A) versus PLD or topotecan in the control arm (Arm B).~   "
87514|NCT02421575|"~     This phase 0 trial studies hydroxychloroquine in blocking autophagy in patients with prostate~     cancer who are undergoing surgery or active surveillance. Autophagy is a process in which~     cells break down some parts of themselves to stay alive during times of stress, such as~     starvation. This may allow cancer cells to survive damage from chemotherapy.~     Hydroxychloroquine may block this process from happening.~   "
87515|NCT02421562|"~     Demonstrate that a 4-day training session will allow nurses to master basic hypnoanalgesia~     techniques, and this new tool will translate into a reduction of procedural distress and pain~     in their patients, thereby opening the way to larger clinical trials in various pediatric~     settings.~   "
87516|NCT02421549|"~     A retrospective, multi-center, proof-of-concept study to evaluate the use of remote~     monitoring in rural emergency departments to decrease time to treatment decision for~     pacemaker and defibrillator patients using the St Jude Medical Merlin@home transmitter. The~     purpose of the study is to determine if utilization of remote monitoring technology in a~     rural emergency department may improve patient care.~      Up to 10 rural ED sites will enroll a total of 200 patients. One hundred patients will be in~     the remote monitoring group comprised of patients with SJM devices compatible with the~     unpaired transmitter and 100 patients will be in the usual medical care group comprised of~     patients with SJM devices that are not compatible with the unpaired transmitter or that have~     a competitor's device.~   "
87517|NCT02421536|"~     This research is being done to evaluate whether or not a customized version of the VibrentTM~     (formerly FitNinjaTM) mobile app is a feasible way to help people manage and control the pain~     from radiation sores (also referred to as mucositis) when treating head and neck cancers~     with radiation. The mobile app will be designed to help people better understand the pain~     from the radiation sores and how to better use their medications especially when they are~     away from the hospital.~   "
87518|NCT02421523|"~     Duchenne muscular dystrophy (DMD) is a debilitating neuromuscular disease that causes muscle~     breakdown, weakness, and eventual death. Over the last 40 years parents have received little~     guidance on the potential of exercise as a therapeutic strategy to maintain muscle function.~     It is well known that high intensity exercise and eccentric contractions can result in muscle~     damage in dystrophic muscle, yet the absence of muscle loading will conversely result in~     muscle wasting. Recent research in rodent models and milder forms of muscular dystrophy~     supports earlier studies that resistance exercise may have beneficial effects for maintenance~     of muscle mass in dystrophic muscle. However, careful and systematic investigation into the~     safety and feasibility of resistance exercise is needed to consider its implementation in~     boys with DMD.~      The goal of this project is to assess the safety and feasibility of a home based mild to~     moderate-intensity strengthening exercise program in boys with Duchenne muscular dystrophy~     (DMD). Evidence from milder forms of muscular dystrophy and mouse models of DMD suggests that~     strengthening exercise may be beneficial for these children, but this area has not been~     adequately explored using human subjects. The results of this study should provide~     information to assist in the development of scientifically based recommendations concerning~     optimal exercise parameters for patients with DMD.~   "
87520|NCT02421497|"~     Magnetic resonance imaging (MRI), as a non-invasive and non-contrast enhanced technique, has~     the potential to improve patient health care and management. The overall objective of~     proposed project is to:~        1. develop, customize, and optimize anatomic and functional MRI methods,~        2. explore the use of MRI methods to study CKD and evaluate post-transplant kidneys, and~        3. investigate the potential of MRI in the diagnosis, prognosis, and monitoring of the~          progression of renal dysfunction.~      In addition to direct studies of the kidney, brain MRI studies will also be performed to~     identify the cerebrovascular and cognitive effects of chronic renal function deficiency and~     medical treatment (e.g. hemodialysis and immunosuppression). The brain and kidneys have~     similar vascular bed, and both are susceptible to vascular injury, which provides the~     pathological basis for the widely recognized association of reduced renal function with~     prevalent cerebrovascular diseases (CVDs) and cognitive impairment (CI). The MRI methods in~     the brain will be applied to explore the origins for widely observed CVDs and prevalent~     cognitive impairment (CI) in kidney disease patients.~   "
87521|NCT02421484|"~     This is a Phase I open label dose escalation trial of human allogeneic bone marrow derived~     mesenchymal stromal cells (MSCs) for the treatment of septic shock. The main purpose of the~     study is to assess the safety of MSCs in patients with septic shock.~   "
87522|NCT02421471|"~     This study is a mandatory post launch observational study in South Korea of 3.000 patients~     receiving treatment for the first time with a new medicinal product, ingenol mebutate gel~     (Picato®), approved for topical treatment of actinic keratosis.~      Each patient is observed for 8 weeks after treatment completion.~   "
87523|NCT02421458|"~     RCT to compare two radiation schemes for palliative HeadNeck cancer~   "
87524|NCT02421445|"~     This is an observational study to characterize human milk of mothers delivering term SGA and~     term AGA infants. This is an observational, exploratory, longitudinal (from birth to 6 months~     postpartum), 4 parallel groups, and multi-centric study. Total 300 subjects will be~     randomised in the study assuming 20% dropout, 240 subjects will be enrolled. The recruitment~     period for the study in India is for 6 months.~   "
87525|NCT02421432|"~     The purpose of this study is evaluation of the safety and the efficacy of transanal total~     mesorectal excision in difficult case.~      Difficult case is defined as below;~      - If any one of the following (1 or 2 or 3)~        1. BMI: 30 or more~        2. Tumor size: more than 7cm in long diameter~        3. CRM: mesorectal fascia involvement or less than 1 mm on MRI~   "
87526|NCT02421419|"~     This research is being done to compare pain relief and efficacy of trigger finger injection~     using a combination of lidocaine/corticosteroid versus corticosteroid injection alone versus~     corticosteroid/saline combination.~   "
87527|NCT02421406|"~     The goal of this project is to determine whether an Internet-based weight loss program will~     lead to weight loss and improvements in cardiovascular disease risk factors in people living~     with HIV.~   "
87528|NCT02421393|"~     Type 2 diabetes mellitus (T2DM) is associated with increased fracture risk despite normal to~     increased bone mass, thus suggesting poor bone quality. This study is aimed at weighing the~     effect of an exercise intervention program on parameters of bone quality in patients with~     type 2 diabetes mellitus. Two hundred patients with T2DM will be randomized to supervised~     exercise training on top of standard care (exercise, EXE, group; n=100) versus standard care~     (control, CON, group; n=100) for 24 months.~   "
87529|NCT02421380|"~     The purpose of the study is to test a new approach to see if the test results can be~     reproduced each time the Magnetic resonance imaging (MRI) is done for an individual patient.~     The study will explore the use of an imaging agent called hyperpolarized [1-13C] pyruvate~     (HP) with MRI scans. (MRI) is a technique that takes pictures of the body's organs using a~     magnetic field and radiofrequency waves that cannot be felt. In order to accomplish the goal~     of the study the patient will have two hyperpolarized MRI scans to assess if scans can be~     reproduced. The hyperpolarized MRI scans will be compared with the pathological results of~     the surgery to see if the hyperpolarized MRI provides additional information regarding~     disease metabolism.~   "
87530|NCT02421367|"~     This study is being conducted to evaluate the safety and immunogenicity and antibody~     persistence of the candidate dengue vaccine.~   "
87531|NCT02421354|"~     The goal of this clinical research study is to learn if nivolumab can help to control MF. The~     safety of this drug will also be studied.~   "
87532|NCT02421341|"~     This study is being done because the investigators are trying to understand how feedback from~     the muscles can influence your blood pressure and breathing during exercise, and if the~     investigators can reduce this response in heart failure patients. The investigators are also~     trying to determine ways to improve tolerance to exercise in heart failure patients.~   "
87533|NCT02421328|"~     This is a prospective, randomized crossover study to recognize the effects of nasal~     continuous positive airway pressure (CPAP) versus heated humidified high flow nasal cannula~     (HHHFNC) on diaphragmatic dimensions and excursion (evaluated by ultrasonography) in preterm~     infants.~   "
87534|NCT02421315|"~     The purpose of this study is to examine the brain functioning of children and adolescent with~     OCD before and after treatment with Exposure and Response Prevention (EXRP) therapy.~   "
87535|NCT02421302|"~     This will be cohort study design with both qualitative and quantitative methods of data~     collection. The investigators are aiming to study 64 HIV positive children as healthy~     controls either initiating ART or already on ART and 86 malnourished HIV infected children on~     ART or naïve initiating ART and RUTF aged between 6 months to 12 years. Primary carers will~     be asked to provide informed consent whereby the children and primary carers will be enrolled~     into the study and followed up for 12 weeks.~   "
87536|NCT02421289|"~     Genetic polymorphisms of cytochrome P450 2B6 (CYP2B6) are associated with lower rate of EFV~     metabolism and lead to high exposure, as well as a higher risk of neuropsychiatric adverse~     event especially homozygous variant CYP2B6 *6/*6. This trial was designed to compare the~     proportion of patients who had undetectable HIV RNA at 24 weeks after ART initiation between~     patient who did CYP 2B6 guided EFV dose and who did not.~   "
87555|NCT02421042|"~     This is a multi-center, open-label, non-randomized, single-dose, sequential-cohort study in~     subjects with varying degrees of hepatic impairment, classified according to the Child-Pugh~     system, who will be matched with normal healthy subjects as controls.~   "
87538|NCT02421263|"~     The current protocol is a pilot study of the effects and possible utility of~     psilocybin-facilitated experiences for professional religious leaders. We hypothesize that~     religious professionals, given their interests, training, and life experience, will be able~     to make nuanced discriminations of their psilocybin experiences, thus contributing to the~     scientific understanding of mystical-type experience. As we better characterize the~     phenomenology of psilocybin-induced mystical experiences, we may apply this knowledge to~     improve potential treatment studies in the future. A primary objective is to investigate~     changes in psychological functioning, spirituality, health, well-being, prosocial attitudes~     and behavior in professional religious leaders that may occur after receiving psilocybin~     under supportive conditions. A secondary objective is to determine whether participants who~     report having had the strongest mystical-type effects during psilocybin sessions will show~     the largest positive changes in the Interim Questionnaire.~   "
87539|NCT02421250|"~     The study is a clinical trial to determine whether more efficient medical and operational~     outcomes can be achieved with using the new SpHb monitoring during triage in the emergency~     room setting. The investigators also evaluate the accuracy of the measurements of the SpHb~     device by Maximo versus the gold standard of central hospital laboratory value. In addition,~     the investigators will assess patient satisfaction with the tool.~   "
87540|NCT02421237|"~     The purpose of the present study is to build upon the investigators' previous exploratory~     intervention development study by conducting an adequately-powered, randomized controlled~     trial of the Narrative Enhancement/Cognitive Therapy (NECT) intervention among persons with~     schizophrenia-spectrum disorders.~   "
87541|NCT02421224|"~     The investigators will conduct a cluster randomized controlled trial of several behavioral~     interventions for smoking cessation among a sample of employees at large workplaces in the~     Bangkok metropolitan area. The study aims to test the impacts of different incentive~     structures for smoking cessation on take-up, effectiveness, and cost-effectiveness. The~     interventions are designed to elucidate certain principles from the field of behavioral~     economics.~   "
87542|NCT02421211|"~     The purpose of this study is to evaluate the pharmacokinetic interactions between simeprevir~     and ledipasvir in a treatment regimen consisting of simeprevir (SMV), sofosbuvir (SOF), and~     ledipasvir (LDV) in treatment-naive participants with chronic hepatitis C virus (HCV)~     genotype 1 infection.~   "
87543|NCT02421198|"~     Over one-third of children and adolescents are overweight and nearly 1 in 5 of them are~     obese. Metabolic syndrome, a strong predictor of Type 2 diabetes (T2D) and cardiovascular~     disease (CVD), occurs in up to 44% of obese youth, foreshadowing greater prevalence and~     earlier onset of T2D. Without effective interventions, diabesity will worsen, T2D~     prevalence will increase, and adults will face its consequences at younger ages. Given the~     strong association between obesity and chronic disease risk factors in youth, the~     investigators contend T2D prevention (and CVD prevention) is akin to weight control and~     obesity prevention. The objective of the proposed project is to develop a family-centered,~     community-based program for T2D prevention in peripubertal (9- to 12-year-old) youth. Using~     participatory methods, the investigators intend to adapt the successful adult-focused YMCA~     Diabetes Prevention Program (YDPP) for youth and families and assess the feasibility,~     participant acceptance of and adherence to the YFDPP using two delivery formats: a 12-week~     YMCA-based face-to-face program and a 12-week combined face-to-face plus mobile device-based~     program. The proposed study will test the investigators premise that delivery with technology~     can reduce participant perceived burden, improve adherence, and lead to improved~     anthropometric (height, weight and BMI and waist circumference), behavioral (diet and~     physical activity) and physiological outcomes (fasting insulin, glucose, lipid, blood~     pressure). The investigators will use the resulting data to design an appropriately powered~     full-scale trial. The importance of the proposed study is underscored both by the statistics~     cited above and the recent call for proposals to translate efficacious clinical interventions~     into effective community programs for youth. The potential impact of the proposed~     intervention is great in that the program will be delivered by paraprofessionals from the~     community without university researchers; significant in that it targets a major public~     health challenge in children and includes assessment of objective behavioral and clinical~     data; and innovative in that it focuses on an at-risk population, takes place at a popular,~     accessible community venue, and uses mobile technologies to extend reach and increase~     engagement of youth and families with intervention content. The long-term goal is to create a~     scalable, replicable, and sustainable program that overcomes existing barriers to~     implementation and dissemination of evidence-based, research-proven diabetes prevention~     programs to youth and families, thereby improving population health.~   "
87544|NCT02421185|"~     The purpose of this study is to determine recommended Phase 2 dose [RP2D]) and the objective~     response rate of JNJ-42756493 (erdafitinib) in advanced hepatocellular carcinoma (HCC)~     participants with fibroblast growth factor (FGF) 19 amplification.~   "
87545|NCT02421172|"~     This is a randomized, double blind, multicenter study in patients with moderate to severe~     chronic hidradenitis suppurativa in parallel groups, to determine the efficacy and safety of~     multiple doses of CJM112 in comparison to placebo. The study has two periods to explore~     preliminary dose effects.~   "
87546|NCT02421159|"~     The Brooklyn Community United (BCU) study is a supplement to the main research study titled~     Peer Driven Intervention to Seek, Test, & Treat Heterosexuals at High Risk for HIV. The~     main study's field name is Brooklyn Community Action Project (BCAP) (R01DA032083, R#:~     11-01257). The main study is testing two approaches to seeking out undiagnosed HIV infection~     (Venue-based Sampling (VBS) and Confidential Two-Session Testing with Navigation (CTTN-RDS)).~      HIV prevalence rates in two previous heterosexual cycles of NHBS in the local area are: 7% in~     HET1 and 12.3% in HET2. The main study, BCAP, found lower prevalence rates of 3.45%, 35.14%~     of which were newly diagnosed in the RDS-CTTN sample and 1.89% newly diagnosed with HIV in~     the VBS sample.~      The primary aim of the Brooklyn Community United (BCU) study is to seek out individuals with~     undiagnosed HIV using a streamlined RDS-CTTN approach, and anonymous HIV Testing in Central~     Brooklyn.~      The supplement study hypotheses are:~      (H1): Compared with VBS and RDS-CTTN, and controlling for potential differences on key~     socio-demographic characteristics across the samples, RDS-ASTN participants will have less~     HIV testing experience.~      (H2) Controlling for potential differences on key socio-demographic characteristics across~     the samples, RDS-ASTN will yield higher rates previously undiagnosed HIV compared with VBS~     and RDS-CTTN.~      (H3): Most participants (> 70%) found to be HIV-infected in the RDS-ASTN intervention will~     engage in the Treat and Retain intervention phase.~      (H4): Most participants in the Treat and Retain phase of the RDS-ASTN intervention (> 70%),~     all of whom will be HIV infected, will be linked to care within 3 months.~   "
87556|NCT02421029|"~     The researchers propose to investigate the prevalence of gadolinium in the urine of patients~     with a prior gadolinium-enhanced MRI before and after a edetate calcium disodium challenge.~     Moreover, will investigate if there is any correlation of gadolinium urine levels with levels~     of endogenous (e.g zinc) and xenobiotic metals.~   "
87547|NCT02421146|"~     The purpose of this project is to examine brain function before, during, and after the~     administration of tDCS (Transcranial Direct Current Stimulation). The brain can perform its~     job well or poorly depending on many things. The investigators will be using computer tasks~     and paper and pencil questionnaires to measure the relationship between brain performance and~     the administration of tDCS. In addition, the study team will be using functional magnetic~     resonance imaging (fMRI) and related imaging techniques to see how your brain works and~     compare it with the results we collected from the paper and pencil questionnaires. This study~     will enroll both schizophrenia patients as well as healthy volunteers without any major~     psychiatric disorder or physical illness.~   "
87548|NCT02421133|"~     In France, it has be estimated that the hospital readmission rate within 30 days of patients~     aged 75 or older is 14% (IC95% [12.0-16.7]), nearly a quarter being avoidable. There is~     evidence that interventions bridging the transition from hospital to home involving a~     dedicated professional (usually nurses) would be most effective in reducing the risk of~     readmission, but the level of evidence of current studies is low. Our study aims to assess~     the impact of a program of transitional care from hospital to home for people of 75 years old~     or more admitted to acute care.~   "
87549|NCT02421120|"~     There is established evidence that adult patients with Cystic Fibrosis (CF) may have altered~     antibiotic pharmacokinetics compared with non-CF patients. Ceftolozane/Tazobactam is a newly~     approved broad spectrum intravenous antibiotic, which has potent in vitro activity against~     multidrug resistant Pseudomonas aeruginosa, the most common pathogen implicated in CF~     pulmonary exacerbations. This study will determine the pharmacokinetics and tolerability of~     ceftolozane/tazobactam in 20 adult CF patients admitted for a pulmonary exacerbation at one~     of 4 participating hospitals in the US. Patients will remain on standard of care IV~     antibiotics and receive 4-6 doses of ceftolozane/tazobactam 3 grams every 8 hours. Blood will~     be sampled after the final dose to determine concentrations and pharmacokinetics of~     ceftolozane and tazobactam. Safety and tolerability will be assessed throughout the 3 day~     study.~   "
87550|NCT02421107|"~     The company who have developed the GlySure product have previously carried out a study to be~     able to show that the GlySure system is accurate in measuring blood sugar (glucose) levels.~     This was done with patients in the intensive care unit (ICU) after heart surgery.~      The company now want to confirm that the GlySure product is accurate at measuring blood~     glucose levels on all patients who stay in the ICU.~      This clinical study requires 40 patients and is to check the safety of a continuous Glucose~     Monitoring System (GlySure) and it's performance in comparison to separate individual blood~     glucose testing using a hand held blood tester called i-STAT. Each patient must be in the~     study for at least 36 hours.~      The main benefit of continuous blood glucose monitoring is that it gives a true picture of~     the glucose status of a patient and this can potentially help avoid the glucose level~     dropping too low (hypoglycaemic) or staying too high (hyperglycaemia) as clinicians can~     intervene based on `real-time` data on the glucose levels.~      In this study patient treatment is not dictated by the data measured during the study.~     Clinicians are blind to the results on the GlySure monitor.~   "
87551|NCT02421094|"~     A Randomized, Controlled, Double-blind, Parallel Group, Single Center Phase 2 Clinical Trial~     to Evaluate Multiple Non-Invasive Liver Fibrosis Imaging Methods in the Assessment of the~     Efficacy of GR-MD-02 for the Treatment of Liver Fibrosis in Patients with NASH with Advanced~     Fibrosis~   "
87552|NCT02421081|"~     The radial and ulnar artery injuries related with the wrist cut are frequently encountered.~     There are many factors which are effective on the improvement of these arterial structures~     was repaired with microsurgical techniques. Recently has begun to focus on neointimal~     thickening and endothelialization of the role in vascular healing and maturation made on~     histopathological study. In this study, the radial and ulnar artery laceration repair healing~     with the microsurgical anastomosis methods on blood CD34, CD133 and CD309 levels of the~     effect of the distribution of lymphoid cells has been investigated. The investigators think~     that; thus by demonstrating the positive impact that may arise; autologous endothelial~     progenitor cells which are obtained in patients; continuation of anastomotic patency~     undergoing coronary by-pass or the in hemodialysis patients with arteriovenous fistula; also~     ensuring the re-flow in patients with acute and chronic peripheral arterial occlusion. The~     investigators believe could be used for the reimplanted tissue in the limb breakage ensuring~     that survive.~   "
87553|NCT02421068|"~     This study will provide information on the pharmacokinetics, safety and effectiveness of~     off--label drugs used in critically ill premature infants: doxapram, fentanyl, midazolam,~     paracetamol, phenobarbital, sildenafil, levetiracetam, ibuprofen and fluconazole. PK/PD~     analysis with NONMEM (non-linear mixed effects modelling) will result in (adapted) dosage~     guidelines, thus contributing towards an improvement in the quality of care and cost~     efficiency. Furthermore the development of Dried Blood Spot (DBS) analysis is investigated~     for these drugs as a minimally invasive method for conventional patient care and to perform~     pharmacological studies in children. The adapted dosage guidelines will be implemented~     directly into clinical practice in collaboration with the NKFK. Therefore the study is~     designed as an observational multicenter study to be able to collect sufficient data for the~     drugs of interest.~   "
87554|NCT02421055|"~     Recent studies have shown that bacteria within the gut play an important role in diabetes~     improvement after bariatric (weight-loss) surgery. Bariatric surgery fundamentally changes~     the environment within the gut, which results in changes to the makeup of the trillions of~     bacteria living within it. These changes in the gut bacteria can affect the body in a number~     of complex ways, which we are only just beginning to understand. For example, gut bacteria~     breakdown food we are unable to absorb ourselves, leading to altered sugar levels and can~     release molecules that act to reduce appetite.~      In this study we aim to find out how bariatric surgery changes the gut bacteria and how this~     leads to weight loss and improvement of diabetes. With this understanding we hope to discover~     potential targets for future treatments, such as identifying beneficial bacteria that could~     be supplemented with probiotics in patients.~      Additionally, although highly successful, up to 30% of obese patients do not undergo~     improvement of their diabetes after bariatric surgery. We aim to identify molecules within~     the patient's blood or urine that are able to predict the likely chance a patient will~     undergo improvement in their diabetes after bariatric surgery to help clinicians select~     patients most likely to benefit.~   "
87558|NCT02421003|"~     The recovered blood into the surgical site at the border of the fields, is very rich in red~     blood cells, due to the adjacency of the bone marrow and the sternum.~      The blood recovered from the surgical site at the border of the fields, is richer in red~     blood cells than the bloodstream of the patient.~      The recovered blood into the surgical site at the border of the fields, is not contaminated~     and bacteriological cultures are negative.~      Consequences: The recovered blood in the surgical site at the edge of fields, can be~     recovered in the Saver® Cell for reprocessing and re-injected into the patient.~      There isn't in our knowledge of published clinical data on the volume and composition of the~     recovered blood in the surgical site after cardiac surgery.~      The analysis of the available literature does not allow to estimate the expected outcomes us.~     Therefore, this study will be exploratory in nature and will aim to estimate the volume and~     the content of red blood cells from blood recovered, and generate clinical data to be used in~     subsequent confirmatory tests.~   "
87559|NCT02420990|"~     Attention-Deficit/Hyperactivity Disorder (ADHD) exists in 20-50% of the 3 million adolescents~     annually enrolled in outpatient mental health and substance use treatment. Adolescents with~     ADHD present deficits in attention, self-regulation, and social competence that significantly~     impede achievement of developmental and educational milestones. Currently there are only two~     evidence-based treatment options for this age group: academic training and stimulant~     medications. Both options remain vastly underutilized. Academic training is not available in~     most school settings and rarely implemented in clinical care. Similarly, ADHD medications are~     rarely utilized with adolescents in primary or specialty care for a host of reasons related~     to stigma, misinformation about effects and side effects, and adolescent autonomy issues.~     Moreover, the widespread fragmentation of pharmacological versus behavioral services prevents~     families from making informed treatment selections.~      The primary objective of this randomized parametric trial is to compare the effectiveness of~     behavioral only versus integrated (behavioral plus medication decision-making) interventions~     for adolescents with ADHD in outpatient behavioral services. The behavioral intervention,~     Changing Academic Support in the Home for Adolescents with ADHD (CASH-AA), contains three~     components: ADHD psychoeducation, family-based motivational interventions, and academic~     training. The medication decision-making intervention, Medication Integration Protocol (MIP),~     contain three components: psychoeducation about ADHD medication, family decision-making, and~     medication management. The study will compare the effects of two legitimate treatment options~     for adolescents with ADHD on service utilization, behavioral symptoms, and quality of life.~     It will generate new evidence on patient-centered treatment selection that aligns with~     family-specific principles and treatment goals.~      This parametric comparative trial will randomly assign 140 inner-city adolescents with ADHD~     to (1) CASH-AA Only or (2) CASH-AA + MIP. Treatment will occur in community behavioral health~     clinics. All participants will receive behavioral interventions (CASH-AA): family~     psychoeducation in ADHD symptoms, executive functioning, and developmental impacts;~     family-based motivation and ADHD accommodation interventions; and academic training focused~     on home environment support and organizational skills. Half of the participants will also~     receive medication decision-making interventions (MIP): ADHD medication psychoeducation,~     family decision-making interventions, and (for those who elect to start medication)~     coordinated medication management. Half of the sample will have comorbid substance use~     problems. Treatment will occur in three community clinics; therapists will be randomly~     assigned to study condition. Caregivers and adolescents will complete assessments at~     baseline, 3, 6, and 12-month follow-up. Multilevel modeling will compare the effectiveness of~     each condition on key patient and service use outcomes. Patient-centered analyses will~     explore differential treatment effects based on (a) Medication decision (yes/no); (b)~     Substance use comorbidity (yes/no); (c) Race/Ethnicity (Hispanic, African American).~      Quantitative outcome analyses will test for service use effects, symptom reduction, and~     quality of life improvements that are primary reasons for seeking clinical services.~     Qualitative interviews will document family-specific rationale for decisions about~     medication, compliance with behavioral and medication interventions, and suggestions for~     improving services and service integration. Note that families assigned to CASH-AA Only will~     retain the option of pursuing ADHD medication through treatment-as-usual procedures at their~     respective clinic. Similarly, families assigned to CASH-AA + MIP will not be required to~     start ADHD medication. Instead, they will receive informed-choice interventions and can~     choose when and if to start medication; the study will assess the impact of these decisions~     on clinical outcomes.~      If proven efficacious, the CASH-AA and MIP protocols could be rapidly disseminated~     individually or as an integrated protocol into routine behavioral healthcare settings. The~     protocols can also be readily combined with other behavioral treatments to form a~     multicomponent treatment package for adolescents with co-occurring behavior problems. In~     addition, the family-based, patient-centered CASH-AA and MIP protocols could be delivered in~     conjunction with other family-based treatments or with individual approaches that flexibly~     include caregivers in multiple treatment sessions. This makes CASH-AA and MIP highly~     efficient clinical resources for addressing ADHD-related problems in any outpatient setting~     that serves adolescents and their families.~   "
87560|NCT02420977|"~     This research is being done to see if an investigational radioactive imaging agent~     (radiotracer) called 18F-DCFPyL can help us find prostate cancer at its original site in the~     prostate gland and in distant sites (bone, lymph nodes) in men diagnosed with prostate cancer~     before surgery.~   "
87561|NCT02420964|"~     The study will be a prospective randomized trial involving human subjects. The study~     population will consist of all infertility patients presenting to the Carolinas Medical~     Center Women's Institute who will require injectable use.~      Exclusion criteria: Any patient with prior history of IVF injectable use will be excluded~     from the study.~      Independent Variables: The independent variable is the random assignment of each participant~     to receive either web-based or one on one teaching.~      Outcome Variables: The primary outcome variable is the level of knowledge after the~     intervention. Secondary outcome variables include level of satisfaction with education,~     preference of educational method, and time required to teach.~      Confounding Variables: Potentially confounding variables include age, race, and prior~     experience with web-based teaching.~   "
87562|NCT02420951|"~     The purpose of this study is to determine if an additional injection of local anesthetic~     immediately prior to removal of the local anesthetic infiltration catheter on postoperative~     day one is effective in increasing pain reduction, patient satisfaction or outcome measures~     following total knee replacement (TKR). It is hypothesized that an additional injection of~     30ml of .5% bupivacaine solution immediately before infiltration catheter removal will~     provide pain reduction, patient satisfaction and outcome measures equal or superior to~     catheter removal with no additional injection.~      Patients who are undergoing unilateral total knee replacement (TKR) and choose to participate~     will be randomly assigned to a treatment group.Patients in group one (treatment group) will~     receive a 30ml dose of .5% bupivacaine solution injected into the local anesthetic~     infiltration catheter immediately prior to its removal on postoperative day one. Patients in~     group two (control group) will receive no additional medication during local anesthetic~     infiltration catheter removal.~   "
87563|NCT02420938|"~     The goal of this clinical research study is to learn if urelumab given in combination with~     rituximab can help to control CLL or SLL. The safety of the drug combination will also be~     studied.~   "
87564|NCT02420925|"~     The investigators hypothesize that in patients with gastroparesis, gastric emptying will~     improve with celiac plexus block. By improving gastric emptying, symptoms related to~     gastroparesis including nausea, vomiting, bloating, abdominal pain, and weight loss, will~     also improve.~      In order to study this hypothesis, the investigators will enroll patients with gastroparesis~     who are non-responsive to the current treatments available. Patients will fill out a~     questionnaire to assess the severity of their symptoms then undergo Ansar testing (a~     non-invasive test) to measure their autonomic function respectively. Then, patients will~     undergo a celiac plexus block which is performed via an upper endoscopy. One week after the~     procedure, patients will be asked to undergo a gastric emptying study as well as repeat the~     Ansar testing to evaluate for any improvement in the gastric emptying and autonomic function~     respectively. Patient will be asked to repeat the questionnaire, one, two, three, and eight~     weeks after their procedure.~   "
87565|NCT02420912|"~     The goal of this clinical research study is to learn if nivolumab in combination with~     ibrutinib can help control chronic lymphocytic leukemia (CLL), non-Hodgkin lymphoma (NHL), or~     small lymphocytic leukemia (SLL). The safety of this drug combination will also be studied.~      This is an investigational study. Nivolumab is FDA approved and commercially available for~     use in melanoma patients. Its use in this study is investigational. Ibrutinib is FDA approved~     and commercially available for the treatment of patients with CLL/SLL. The use of these drugs~     in combination is considered investigational. The study doctor can explain how the drugs are~     designed to work.~      Up to 72 participants will be enrolled in this study. All will take part at MD Anderson.~   "
87566|NCT02420899|"~     The purpose of this study is to determine whether Rosuvastatin 10mg/d or 20mg/d for 36 weeks~     can regress critical coronary atherosclerosis as determined by IVUS imaging in Chinese Acute~     Coronary Syndrome (ACS) patients.~   "
87567|NCT02420886|"~     Assessment of the embryological benefit of in vitro adding of Cytokines (LIF 5ng/ml, HB-EGF~     5ng/ml and GM-CSF 2n/ml) to the culture media and closely monitor its effect on embryogenesis~     and implantation outcomes.~   "
87568|NCT02420873|"~     The goal of this clinical research study is to learn if lorvotuzumab mertansine can help to~     control blood cancers that have the CD56 tumor marker. The safety of this drug will also be~     studied.~   "
87569|NCT02420860|"~     The goal of this clinical research study is to learn if the combination of elotuzumab and~     revlimid (also called lenalidomide) can help to prevent multiple myeloma (MM) from coming~     back after patients have had an autologous stem cell transplant (a transplant using your own~     stem cells). The safety of this drug combination will also be studied.~      This is an investigational study. Lenalidomide is FDA-approved and commercially available for~     the treatment of MM and myelodysplastic syndrome (MDS). Its use after an autologous stem cell~     transplant is investigational. Elotuzumab is FDA-approved in combination with lenalidomide~     and dexamethasone for relapsed/refractory multiple myeloma.~      The study doctor can explain how the study drugs are designed to work.~      Up to 100 participants will be enrolled in this study. All will take part at MD Anderson.~   "
87570|NCT02420847|"~     This clinical research study is made up of 2 phases.~      The goal of Phase 1 of this study is to learn the highest tolerated dose of the combination~     of ixazomib, gemcitabine, and doxorubicin that can be given to patients with urothelial~     cancer.~      The goal of Phase 2 of this study is to learn if the combination of ixazomib, gemcitabine,~     and doxorubicin can help to control urothelial cancer.~      The safety of the drug combinations will be studied in both phases.~      This is an investigational study. Ixazomib is not FDA approved or commercially available for~     the treatment of urothelial cancer. Gemcitabine and doxorubicin are FDA approved and~     commercially available for several other types of cancer. Their use in combination with~     ixazomib in urothelial cancer is investigational.~      The study doctor can explain how the study drugs are designed to work.~      Up to 57 participants will be enrolled in this study. All will take part at MD Anderson.~   "
87571|NCT02420834|"~     Dry eye is a chronic irritating eye condition that affects many people, caused by poor tear~     quality and insufficient quantity. Treatments are traditionally in the form of artificial~     tears applied to the ocular surface. However, there is little evidence in the scientific~     literature that demonstrates their efficacy relative compared to each other, nor how to~     decide which one might be most effective for an individual patient. Therefore the~     investigators aim to examine the efficacy of different classes of artificial tears (those~     designed to increase viscosity, reduce evaporation or to mimic the component balance of the~     natural tears). In addition, the investigators also aim to determine how the treatment~     preferred by an individual could potentially have been predicted from their baseline~     condition.~   "
87572|NCT02420821|"~     This multi-center, randomized, open-label study will evaluate the efficacy and safety of~     atezolizumab (MPDL3280A) plus bevacizumab versus sunitinib in participants with inoperable,~     locally advanced, or metastatic renal cell carcinoma (RCC) who have not received prior~     systemic active or experimental therapy, either in the adjuvant or metastatic setting.~   "
87573|NCT02420808|"~     A nationwide registry of patients with acute coronary disease to evaluate epidemiological~     patient characteristics, medical management, implementation of invasive strategy, patient~     outcome and impact on quality of life in Greece.~   "
87574|NCT02420795|"~     This clinical research study will be done in two parts.~      The goal of the first part is to find the highest tolerable dose of ONC201 that can be given~     to patients with relapsed or refractory MCL, DLBCL, and TLCL. Groups of subjects will receive~     increasing doses of ONC201 by mouth on day 1 of each 21 day cycle or on Day 1 of every week~     until there are side effects that are not tolerated or a maximum of 625 mg has been found to~     be tolerable.~      As a result of new information, it has been decided that subjects in Arm A will continue~     receiving their dosing every 3 weeks. All other subjects will be dosed weekly.~      The dose you receive may be too low to have an effect or so high it causes bad side effects.~      In the second part of this study the highest dose of NC201 will be given to learn if ONC201~     can help to control the disease.~      Please note that this is the first time ONC201 will be given to human subjects.~   "
87575|NCT02420782|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK)~     and pharmacodynamics (PD) of single and multiple ascending oral doses of ASP6282 in healthy~     male and female subjects. 1 cohort (elderly) receives also a midazolam dosing.~      This study will also explore the effect of itraconazole (another drug) on the PK of ASP6282,~     as well as to evaluate the safety and tolerability of ASP6282 alone and in combination with~     itraconazole in healthy male and female subjects.~      Also, this study is to evaluate the PD and PK effects of single oral doses of ASP6282 on~     pilocarpine-induced salivation and pupil diameter in healthy nonelderly male and female~     subjects.~   "
87576|NCT02420769|"~     The purpose of this study is to determine whether assessing color doppler of corpus luteum~     and uterine artery is useful in predicting patients who will complete pregnancy. The~     investigators will add to this the usefulness of serum progesterone and CA125 in prediction.~   "
87577|NCT02420756|"~     The Imaging Dementia—Evidence for Amyloid Scanning (IDEAS) Study will establish an~     open-label, longitudinal cohort study to assess the impact of amyloid PET on patient~     outcomes. The study will be performed in accordance with the Center for Medicare & Medicaid~     Services (CMS) policy of Coverage with Evidence Development (CED) in Medicare beneficiaries~     who meet the Appropriate Use Criteria (AUC) for amyloid PET (Johnson et al. 2013). Our~     hypothesis is that amyloid PET will decrease uncertainty and increase confidence in the~     underlying cause of cognitive impairment, that this will translate into earlier counseling~     and interventions in these domains, and that these interventions will lead to improved~     outcomes.~   "
87578|NCT02420743|"~     Pregnant women with iron deficiency anemia during third trimester will be assessed for serum~     ferritin and peak systolic value for fetal middle cerebral artery to find out their~     correlation with preterm delivery.~   "
87579|NCT02420730|"~     This study will examine the safety, tolerability, and systemic pharmacokinetics of up to 3~     different concentrations of AGN-232411 topical ophthalmic solution in healthy participants~     and participants with dry eye.~   "
87580|NCT02420717|"~     The goal of this clinical research study is to learn if ruxolitinib or dasatinib in~     combination with chemotherapy can help to control Philadelphia Chromosome (Ph)-like acute~     lymphoblastic leukemia (ALL). The safety of these drug combinations will also be studied.~   "
87581|NCT02420704|"~     Although many studies have evaluated the relationship between endometrial thickness and IVF~     outcome, the results are still controversial. We notice that, during our daily work, for~     patients undergoing cleavage stage embryo transfer, endometrial thickness seems to have a~     huge impact on IVF outcome; however, for blastocyst stage embryo transfers, IVF outcome seems~     to have little association with endometrial thickness. Thus, the aim of this prospective~     observational study is to explore the relationship between endometrial thickness and IVF~     outcome in patients undergoing cleavage stage and blastocyst stage embryo transfers,~     respectively.~   "
87582|NCT02420691|"~     The goal of this clinical research study is to learn if LEE011 can help to control advanced~     neuroendocrine tumors of the foregut. The safety of this drug will also be studied.~   "
87621|NCT02420184|"~     This study is being conducted to determine whether treatment of obstructive sleep apnea (OSA)~     in patients with chronic kidney disease (CKD) improves kidney function. Half of the~     participants will receive continuous positive airway pressure (CPAP) treatment for their OSA~     in addition to their regular CKD treatment, while the other half will only receive their~     regular CKD treatment.~   "
87583|NCT02420678|"~     Hepatocellular carcinoma (HCC) is the sixth most common cancer and the second leading cause~     of cancer-related mortality worldwide. Despite the recent advances in the treatment of HCC,~     the prognosis of HCC is still poor even after curative treatment.~      Performance status has shown to be associated with long-term survival and prognosis in~     patients with HCC, and it is one of the important factors in the Barcelona Clinic Liver~     Cancer (BCLC) staging system. Recently, the researches on health-related quality of life~     (HRQL) of cancer patients have been progressed. The most widely used surveys to assess HRQL~     of cancer patients are Functional Assessment of Cancer Therapy-Generic (FACT-G) and European~     Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire~     (QLQ)-C30. Since those two are mainly about cancers in general, HCC specific surveys were~     developed.~      The FACT-Hep questionnaire has 45-items specifically focusing on patients with hepatobiliary~     cancers. EORTC QLQ-hepatocellular carcinoma 18 (HCC 18) is an 18-item questionnaire designed~     to be used along with the EORTC QLQ-C30 for patients with HCC. An 18-item National~     Comprehensive Cancer Network (NCCN)-FACT Hepatobiliary-Pancreatic Symptom Index (NFHSI-18) is~     a specific questionnaire for advanced hepatobiliary and pancreatic cancers. However, there is~     no consensus whether it would be appropriate to adopt HRQL as a prognostic variable in HCC~     staging system. Moreover, there is limited information available about the impact of~     patients' HRQL on long-term outcome in patients with HCC.~      Thus, in this study, the researchers will investigate whether HRQL can be an important factor~     in HCC staging system by testing the reliability and clinical validity of FACT-Hep, EORTC~     QLQ-HCC18, and NFHSI-18. Second, the investigators will evaluate the relation of HRQL with~     treatment efficacy, recurrence and survival outcome. Lastly, the investigators will suggest~     the suitable questionnaire module for patients with HCC.~   "
87584|NCT02420665|"~     The goal of this clinical research study is to compare a type of imaging called~     high-resolution microendoscopy (HRME) for detecting abnormal tissue in the cervix to the~     standard of care, which is visual inspection with acetic acid (VIA) with a colposcopy~     procedure. Researchers also want to learn if HRME images can show the difference between~     cancerous tissue and normal cervical tissue.~   "
87585|NCT02420652|"~     This randomized phase II trial studies how well metformin hydrochloride and aspirin work in~     treating patients with hormone-dependent prostate cancer that has progressed after surgery or~     radiation therapy. Metformin hydrochloride and aspirin may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. It is not yet known whether giving~     metformin hydrochloride and aspirin together can slow the growth of prostate cancer.~   "
87586|NCT02420639|"~     The aim of this prospective, interventional study is to assess the feasibility and safety of~     the Esophageal Cooling Device in patients from suffering from traumatic brain injury who the~     treating physician is treating with targeted temperature management. Comparison of outcomes~     will be made to historical controls. The primary outcome is the feasibility of inducing,~     maintaining, and rewarming patients from targeted temperature management using the Esophageal~     Cooling Device (cooling rate, rewarming rate, and the percent of time within goal temperature~     during the goal-temperature maintenance period). Evaluation of adverse events (including~     cardiac arrhythmias, severe bradycardia, myocardial infarction/re-infarction, dysphagia,~     odynophagia, aspiration pneumonia, non-aspiration pneumonia, reflux, esophageal injury, and~     esophagitis) will be closely monitored during the whole period of targeted temperature~     management (secondary endpoint).~   "
87587|NCT02420626|"~     The Crux Vena Cava Filter (VCF) Registry is a clinical study, sponsored by Volcano~     Corporation, to evaluate the short and long term performance and clinical outcomes of the~     Crux Vena Cava Filter System.~   "
87588|NCT02420613|"~     The goal of this clinical research study is to learn the highest tolerable dose of~     temsirolimus that can be combined with a stable dose of vorinostat and/or radiation therapy~     and given to patients with diffuse intrinsic pontine glioma (DIPG). The safety of this~     treatment combination will also be studied.~   "
87589|NCT02420600|"~     Head and neck squamous cell carcinomas (HNSCCs) are mainly caused by tobacco, alcohol~     consumption and betel nut chewing and the sixth most common cancer in the world. Despite~     significant advances in the treatment modalities involving surgery, radiotherapy, and~     concomitant chemoradiotherapy, the 5-year survival rate remained below 50% for the past 30~     years.~      The worse prognosis of these cancers must certainly be linked to the fact that HNSCCs~     strongly influence the host immune system. During this process, mesenchymal tumor-like cells~     are highly mobile and enter quickly adjacent structure (intravasation), from where they~     travel through lymphatic and blood vessels as circulating tumor cells (CTC), which are single~     cells with malignant potential detected in the peripheral bloodstream and essential for~     establishing metastasis.~      Programmed death 1 (PD-1) and its ligand (PD-L1) play pivotal roles in regulating host immune~     responses. Substantial evidence has demonstrated that PD-L1 can deliver an inhibitory signal~     to PD-1 expressing T cells, leading to suppression of the immune response by inducing~     apoptosis, energy, unresponsiveness and functional exhaustion of T cells. However, the~     inhibitory effects of this pathway on the function of cytotoxic T lymphocytes, the main~     effector cells in HNSCC patients, are not well defined.~      In this study aims to solve two main problems: one is to improve and try to optimize current~     protocols of CTC isolations based on the investigator previous work, which is one of most~     challenging problems in CTC field to date; the other is to understand the status of immune~     system in HNSCC patients, especially focusing on PD-1-PD-L1 pathway and its expressions.~     After series basic experiments of immune cell analysis and conditional adjustment of CTC~     isolation protocols, the investigator are willing to isolate CTCs and immune cells at a~     single blood drawing at the same time. A prospective trial will be conducted to elucidate the~     roles of PD-1 expression lymphocytes and CTC numbers on the clinical outcomes of HNSCC~     patients.~   "
87590|NCT02420587|"~     The goal of this clinical research study is learn how AMG208 may help to control prostate~     cancer that has spread to the bone. The safety of the drug will also be studied.~   "
87591|NCT02420574|"~     Infections with soil-transmitted helminthes (STH) occur throughout the developing world and~     remain a major public health problem in the poorest communities. Preventive chemotherapy (PC)~     programs in which single-dose albendazole 400 mg or single-dose mebendazole 500 mg - the~     drugs of choice for STH - are administered at the population level, is the main strategy for~     STH control. To ensure quality, these drugs are being widely donated by GlaxoSmithKline (GSK)~     (albendazole (ALB), Zentel) and Johnson & Johnson (mebendazole (MEB), Vermox). In addition to~     this, there are a wide variety of ALB and MEB tablets available on the local market. Although~     little is known about the quality of anthelmintics sold for human use, several publications~     have reported variability in the quality of generic anthelmintics used in veterinary~     medicine. The main objective of the present study is to compare the efficacy of two ALB~     brands bought on the local market, including OVIS (Korea, DAEHWA pharmaceutical) and BENDEX~     (India, Cipla)~   "
87592|NCT02420561|"~     The study aims to evaluate the effectiveness of an intervention to reduce alcohol and drug~     use and depression symptoms, improve functional status and promote appropriate health~     services utilization, in a sample of 300 adults seeking treatment for depression who also~     report hazardous drinking or drug use with depression.~   "
87593|NCT02420548|"~     The Safe, Healthy, Adolescent Relationships and Peers study seeks to understand some of the~     factors that contribute to the behaviors and health of teen girls, such as girl's~     friendships, their dating behaviors, their risk-taking behaviors, and their knowledge about~     how to make healthy choices. This study will inform us on ways to help teen girls engage in~     safe and healthy relationships and adjustment.~   "
87594|NCT02420535|"~     Behavioral symptoms that commonly occur with dementia are associated with increased health~     care utilization and can lead to challenges for the person living with dementia and their~     caregivers. Caregivers need knowledge and skills to monitor these behaviors, to identify what~     triggers them, and to learn how to use proven, practical medication-free strategies to~     prevent and manage the behaviors. The purpose of this study is to develop and test the~     WeCareAdvisor, a customized, internet-based computer tool for family caregivers that helps~     them to assess, manage and track behavioral symptoms and their contributing factors (e.g.,~     pain, sleep disturbance), and that provides tailored strategies for in-home, medication-free~     behavior management. This study is a collaboration between researchers at the University of~     Michigan and Johns Hopkins University.~   "
87595|NCT02420522|"~     This is a pilot study to test the efficacy of repetitive transcranial magnetic stimulation~     (rTMS) on cognitive improvement in individuals with mild cognitive impairment (MCI). The main~     objective of this study is to investigate the ability of rTMS to produce cognitive~     improvement in individuals with MCI. A secondary objective is to determine whether~     individuals with MCI following mild brain trauma respond differently to rTMS treatment~     compared to individuals with non-trauma related MCI.~      All participants will undergo both active and sham (placebo) rTMS treatment. Cognitive and~     psychological assessments will be administered before and after each week of rTMS therapy,~     for both active and sham conditions. Cognitive testing will include verbal, semantic, logic,~     visual, conceptual, and memory tasks.~   "
87596|NCT02420509|"~     The purpose of this study is to find out if postoperative chemotherapy in patients with~     high-grade appendix cancer after surgery improves outcomes.~      The postoperative chemotherapy will consist of 5-FU (with leucovorin) or capecitabine with~     bevacizumab. These drugs are approved for use in people with colon cancer, and they are used~     at UCSD for some patients with appendix cancer.~      The purpose of this study is to explore the safety and efficacy of the postoperative~     chemotherapy treatment on cancer.~   "
87597|NCT02420496|"~     To investigate the effect of enteral fish oil and UDCA on the time of cholestasis resolution~     and other markers of parenteral nutrition-associated liver disease.~   "
87598|NCT02420483|"~     The authors to measure passive tidal volumes generated during external chest compressions in~     order to determine whether chest compressions alone without any mechanical ventilatory~     support in cardiopulmonary resuscitation can provide adequate ventilation. The authors will~     study 25 volunteers who meet the following inclusion criteria: age 18-55 years, ASA I-II,~     candidates for surgical operation, who will receive general anesthesia. Patients who will be~     operated in the chest, who present musculoskeletal diseases, cardiopulmonary or vascular~     acute or chronic diseases, who had history of pneumothorax, of thromboembolism, osteoporosis,~     menopause, history of current rib or sternal or clavicle fractures, will be excluded. All~     eligible patients will enter the study and will receive general anesthesia and intubation~     according to treating doctors' decision.~      Patients will be ventilated mechanically for 5 minutes to establish stable conditions. A~     pneumotachograph will be then connected to the ventilatory circuit so that respiratory~     efforts (volume, airway pressure and flow) can be continuously monitored at real time.~      An esophageal catheter will be then inserted to monitor esophageal pressures and to provide~     data for lung mechanics calculation. Following the above procedures and before any surgical~     procedure, chest compressions will be performed to the patient by a senior anesthesiologist~     according to ERC guidelines of 2010 for 30 seconds.~      Following chest compressions, patients will be evaluated for possible complications and after~     the establishment of stable conditions surgical procedures will follow. After the end of the~     surgical operation clinical and chest ultrasound evaluation will be performed.~      Written inform consent will be obtained by all patients before procedures.~   "
87599|NCT02420470|"~     Diabetes( mainly type II diabetes )lead to the central nervous system (CNS) function~     impairment, especially the mild cognitive impairment that increased the risk of progression~     to dementia.The primary objectives are defined according to a hierarchical design: i) to~     tailor and apply multi-parametric, functional MRI techniques to identify cerebral~     abnormalities (cerebral biomarkers) in type 2 diabetes mellitus and prodromal diabetes~     mellitus ; ii) to assess whether these cerebral biomarkers are associated with cognitive~     decrements;iii) to follow up with the putative prediabetic condition patients to verify~     whether they can transform into diabetes.~   "
87600|NCT02420457|"~     The investigators are assessing the validity of fitness devices as surrogate measures of~     chronic pain survey outcomes.~   "
87601|NCT02420444|"~     70 subjects received BCG intradermally at Study Day -42, then at Study Day 0 were randomized~     to receive AERAS-404 50 mcg H4/500 nmol IC31 intramuscularly as a 3-dose (N=30) or 2-dose~     (N=30) regimen, or placebo (N=10). Subjects were vaccinated on Study Days 0, 56, and 231, and~     followed through Study Day 259.~   "
87602|NCT02420431|"~     Cardiac rehabilitation (CR) services aim to improve heart disease patients' health and~     quality of life, and reduce the risk of further cardiac events. Depression and anxiety~     (distress) are common among CR patients: 37% of patents have significant anxiety and/or~     depressive symptoms. Distressed patients are at greater risk of death, further cardiac events~     and poorer quality of life than those without distress and they use more healthcare.~     Available drug and psychological treatments have only small effects on distress and quality~     of life, and no effects on physical health. Therefore, it is essential that more effective~     treatments for depression and anxiety are integrated into CR services. Extensive evidence~     shows that a particular style of thinking dominated by rumination (dwelling on the past) and~     worry maintains emotional distress. A psychological intervention (metacognitive therapy) that~     reduces this style of thinking alleviates depression and anxiety in mental health settings.~     The investigators aim to conduct a pilot trial of the group intervention and in work stream 2~     the investigators will undertake a full-scale trial to evaluate whether adding the group~     intervention to standard CR is more effective at alleviating anxiety and depression than~     standard CR alone.~   "
87603|NCT02420418|"~     Background: . Bipolar disorders and tobacco use disorder are top of the causes of disability~     and mortality worldwide Objective: The aim of this study was to evaluate N-acetyl-cysteine~     (NAC) as an adjunctive treatment in patients with bipolar .disorders and tobacco use disorder~     (TUD)~      , to determine whether NAC reduces alterations in biomarkers of inflammatory and oxidative~     stress Methods: This study will be conducted as a double-blind, randomized, placebo~     controlles add NAC or placebo for .bipolar disorders and tobacco use disorder at Londrina~     State University, Brazil.~   "
87608|NCT02420353|"~     Anterior cruciate ligament (ACL) tears are among the most frequent traumatic knee injuries~     that occur in physically active individuals. Despite advances in minimally invasive surgical~     reconstruction techniques and aggressive rehabilitation, this atrophy and loss of strength~     can persist even after patients return to full activity and can place them at considerable~     risk for re-injury and developing osteoarthritis (OA). The design of new therapeutic~     interventions to prevent muscle atrophy is needed to advance the care of patients who suffer~     from ACL injuries. The growth hormone (GH)/insulin-like growth factor-1 (IGF-1) axis plays an~     important role in promoting muscle growth and protecting muscle from atrophy. While GH~     therapy has shown promise in protecting immobilized muscle from various models of disuse~     atrophy, it remains unknown whether GH can help to restore strength and protect against the~     loss in strength that occurs after ACL tear. GH therapy may help to accelerate the safe~     return to play of patients that suffer ACL tears, and help to prevent the long-term OA and~     reduction in quality of life that occur after these traumatic knee injuries.~   "
87609|NCT02420340|"~     This pilot study will collect information about the the potential to use an evidence-based~     skills training program designed for older people with serious mental illness (SMI), the~     Helping Older People Experience Success (HOPES) program, to help nursing home residents with~     SMI gain the skills needed to successfully live in the community.~   "
87610|NCT02420327|"~     The aim of this study is to test whether the attention-enhancing effects of low-dose nicotine~     can be enhanced by the drug galantamine, FDA-approved for the treatment of Alzheimer's~     disease. This proof-of-principle study is performed in healthy non-smokers and involves two~     single exposures to a nicotine patch (7 mg/24 hrs) and two single exposures to galantamine (4~     mg). The dose of galantamine is substantially lower than the clinical dose range of 16-24~     mg/day. The hypothesis is that performance-enhancing effects of nicotine are greater in the~     presence of this low dose of galantamine.~   "
87611|NCT02420314|"~     This clinical trial evaluates adding high-dose ascorbate (vitamin C) to standard of care~     treatment of non-small cell lung cancer (NSCLC) in adults. All subjects will receive~     high-dose ascorbate in addition to the standard treatment.~   "
87612|NCT02420301|"~     Objective: To study the effects of self-administered exercises based on tuina techniques on~     the pain intensity caused by playing related musculoskeletal disorders (PRMD) of professional~     orchestra musicians, using numeric visual scale (NVS).~      Method: The investigators performed a prospective, controlled, single-blinded, randomized~     study with musicians suffering from PRMD. n= 69 musicians were randomly distributed into the~     experimental and into the control group. After an individual diagnostic assessment, specific~     tuina self-administered exercises were developed and taught to the participants. Musicians~     were instructed (educated) to repeat the exercises every day during 3 weeks. Pain intensity~     was measured by NVS before the intervention and after the 1st, 3rd, 5th, 10th, 15th and 20th~     days of self-exercising. The procedure was the same for the control group, however the Tuina~     exercises were executed in non-acupuncture points~   "
87613|NCT02420288|"~     The aim of this study is to examine the effect of a supervised physical exercise program~     during pregnancy on fetoplacental growth.~   "
87614|NCT02420275|"~     After a brain injury (BI) , patients complain in particular about sequel fatigue. This~     symptom affects about 50 % of the patients; it is severe, with a repercussion on quality of~     life, reeducation and occupational reintegration, and persists often at a distance of the~     accident. The investigators' hypothesis is that patients who presented a severe BI could~     benefit from a treatment by withe blue enriched bright light in order to improve fatigue and~     quality of life.~   "
87615|NCT02420262|"~     This trial is conducted globally. The aim of this trial is to compare efficacy and safety of~     insulin degludec/liraglutide (IDegLira) versus basal-bolus therapy in combination with~     metformin in subjects with type 2 diabetes mellitus.~   "
87616|NCT02420249|"~     Objectives: (1) To investigate the effects of Qigong training on upper limb oedema,~     circulatory status, shoulder flexibility and muscular strength, body balance, and quality of~     life (QOL) in community-dwelling breast cancer survivors; and (2) to explore the relationship~     between the impairment outcomes and QOL outcomes.~      Hypothesis: (1) The experimental participants will have less impairment and a better QOL~     after Qigong training compared with the no-training control group; and (2) the impairment~     parameters will be related to the QOL indexes in the Qigong participants.~      Design and subjects: This will be a prospective, randomised, single-blinded controlled trial.~     Approximately 60 breast cancer survivors will be randomly assigned to either the Qigong~     training group (n~30) or control group (n~30).~      Intervention: Participants in the Qigong group will receive 18 Forms of Tai Chi Internal~     Qigong training for 3 months with two supervised 1-hour sessions per week.~      Main outcome measures: The primary outcome measures are upper limb circumference, arterial~     blood flow velocities and resistance index, shoulder joint passive range of motion, muscular~     strength (peak force) and body balance. The secondary outcome measure is quality of life as~     measured by the Functional Assessment of Cancer Therapy - Breast scale.~      Data analysis: Data will be analysed via repeated-measures analysis of variance followed by~     post-hoc tests (α = 0.05).~      Expected results: The investigators pilot studies produced encouraging results on the~     efficacy of Qigong exercise in reducing chronic breast cancer-related symptoms in survivors.~     Therefore, the investigators expect that participants in the Qigong group will have fewer~     upper limb impairments and a better quality of life after Qigong training. If the results are~     positive, this Qigong training regime is readily transferrable to clinical practice, and~     could have positive socioeconomic effects such as reduced healthcare costs.~   "
87617|NCT02420236|"~     The purpose of this study is to investigate if high-intensity resistance training can induce~     additional beneficial effects, for patients with moderate to severe long term pain in the low~     back, when added to a multidisciplinary treatment program.~   "
87618|NCT02420223|"~     This is a randomized controlled pilot study designed to evaluate whether the beta-adrenergic~     antagonist propranolol is effective in decreasing gene expression of stress-mediated~     beta-adrenergic pathways among a cohort of individuals receiving an autologous hematopoietic~     stem cell transplant (HCT) for multiple myeloma.~   "
87619|NCT02420210|"~     This phase II trial studies how well bendamustine hydrochloride, obinutuzumab, and~     dexamethasone work in treating older patients with diffuse large B-cell lymphoma. Drugs used~     in chemotherapy, such as bendamustine hydrochloride and dexamethasone, work in different ways~     to stop the growth of cancer cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Monoclonal antibodies, such as obinutuzumab,~     may find cancer cells and help kill them. Giving bendamustine hydrochloride, obinutuzumab,~     and dexamethasone may kill more cancer cells.~   "
87620|NCT02420197|"~     The purpose of this study is to investigate if high-intensity resistance training can induce~     additional beneficial effects, for patients with moderate to severe long term pain in the~     neck, when added to a multidisciplinary treatment program.~   "
87623|NCT02420158|"~     This pilot study plan to investigate the sympathovagal balance in women affected by Irritable~     Bowel Syndrome (IBS), and to evaluate the effect of 6 months of trans-cutaneous vagal nerve~     electrical stimulation on digestive physiology (intestinal transit time, intestinal mucosal~     permeability, systemic and local inflammation), symptoms and quality of life.~      The safety of the electrical stimulation of the left vagal nerve will also be evaluated.~      Ten women, age between 18 and 60, will be included.~   "
87624|NCT02420145|"~     The aim of this randomized trial is to investigate the effects of a 12-week yoga intervention~     compared to no specific intervention on weight-related outcomes, well-being, and health~     behaviour in 60 females with abdominal obesity.~   "
87625|NCT02420132|"~     This pilot study will evaluate home vision testing using a mobile medical application in~     participants with diabetic macular edema (DME) or neovascular age-related macula degeneration~     (nAMD) who receive intravitreal ranibizumab therapy. In the main, decentralized study,~     participants will be recruited via digital media, advocacy groups, or through their own~     ophthalmologist. The traditional substudy will evaluate the association between visual acuity~     and anatomical markers of disease status determined using clinical gold standard~     assessments (certified Early Treatment Diabetic Retinopathy Study [ETDRS] protocol visual~     acuity and macula optical coherence tomography [OCT]) and the results of home vision testing~     using the myVisionTrack^TM (mVT) application.~   "
87626|NCT02420119|"~     Intravenous iron therapy is common and effective, with few side effects. Two formulations are~     used, venofer or iron sucrose and ferrlecit, or ferric gluconate.~      The association between intravenous iron use and decrease in serum phosphorus and vitamin D~     levels, with increased fractional excretion of phosphorus, has been observed with older iron~     preparations, such as saccharated ferric oxide. However, hypophosphatemia and osteomalacia~     have been reported with iron carboxymaltose, a newer iron formulation. There is no~     information in the literature about phosphorus and vitamin D levels after treatment with~     venofer or ferrlecit. We intend to check phosphorus and vitamin D serum levels in our~     patients prior to and after treatment with these iron formulations.~   "
87627|NCT02420106|"~     The purpose of the proposed research is to determine if Osteopathic manipulative medicine~     (OMM) used alone or in combination with the standard treatment of botulinum toxin~     intramuscular injections improves motor function and quality of life amongst people with~     cervical (neck) dystonia.~   "
87628|NCT02420093|"~     The aim of this study is to examine the clinical effects of supporting the human pelvis in a~     neutral sitting position in subjects with Low Back Pain over a 3-week period. The neutral~     sitting posture will be supported by a portable and adjustable pelvic support device or~     pelvic support assembly per US Patent number US 8,857,906 B2 that is used in the seat of~     the user's desk chair.~   "
87629|NCT02420080|"~     The objective is data collection to determine background rates of adenovirus (AdV)~     progression and mortality in subjects with Adenovirus (AdV) infection and/or disease.~   "
87630|NCT02420067|"~     The purpose of the study is to investigate how best to screen for Endolymphatic sac tumors~     (ELSTs) in von Hippel-Lindau (vHL) patients in order to diagnose the ELSTs while they are~     still small so that hearing loss can be prevented.~      Up to 16% of vHL patients are known to develop endolymphatic sac tumors in the inner ear that~     can cause permanent hearing loss. However, the ELSTs are often not found before hearing loss~     has already occurred. The challenge for doctors is to diagnose the ELSTs at early stages~     before they cause often irreversible deafness. In order to find ELSTs before they cause~     hearing loss, it is important to screen for the tumors prophylactically, that is screen all~     vHL patients regardless of whether or not they have symptoms.~      Who can join? Persons diagnosed with vHL who are at least 15 years old. The investigators~     include patients WITH OR WITHOUT a diagnosed ELST.~      What does it involve? You need to have a hearing test and an MRI of the brain, where the~     inner ear can be seen, most vHL patients have already had this done as part of their~     surveillance program.~      Participants will be asked to participate in follow up examinations (hearing test and/or MRI~     of the brain) after 2, 5, and 10 years.~      How can I join? A doctor has to be responsible for the study in each country where vHL~     patients participates.~      Ask the doctor who manages your vHL examinations to contact us or contact us yourself and the~     investigators will help you find a doctor in your country who will participate in the study.~   "
87631|NCT02420054|"~     The purpose of the study is to determine the effect of intermittent fasting on insulin~     secretion and insulin sensitivity in skeletal muscle and fat distribution.~   "
87632|NCT02420041|"~     The purpose of this research project is to compare two different techniques for performing an~     injection of the sacroiliac joint. Although both techniques are safe and accurate, the goal~     of the study is to determine if one technique is better than the other with respect to~     improvement in a patient's pain, function, and his or her satisfaction. Additionally, the~     investigators want to determine if one technique is quicker and more efficient than the~     other.~   "
87633|NCT02420028|"~     A prospective, single-center, open-label, randomized controlled trial to assess the safety~     and efficacy of the OptiVein IV Catheter in an oncology population. The study hypothesis is~     that OptiVein IV Catheter use will be superior to the control in successful venous access~     after first attempt.~   "
87634|NCT02420015|"~     This study is designed to evaluate if a treatment the investigators call iCOMMIT is effective~     at helping smokers with schizophrenia stop smoking. iCOMMIT is a smoking cessation treatment~     that combines mobile technology with behavioral strategies, counseling, and medications.~   "
87635|NCT02420002|"~     This is a therapeutic, randomized, single center, two parallel-arm trial comparing pain~     control via MEOPA (equimolar mixture of nitrous oxide and oxygen) in one arm versus~     Hypnosis + MEOPA if needed in the second arm.~      The primary objective is to compare the two study arms in terms of efficacity for pain~     control according to the FLACC (Face Legs Activity Cry Consolability Observational Tool)~     behavioural scale.~   "
87659|NCT02419690|"~     This study aims to use a text messaging intervention to prevent unintended teen pregnancy and~     transmission of sexually transmitted disease. The study will be informed by a formative~     qualitative phase (February 2014 - January 2015) which will include individual qualitative~     interviews and focus group with teens to elucidate and explore the barriers to effective~     contraceptive use and sexually transmitted disease (STD) prevention and to obtain feedback on~     the developed intervention. The second efficacy phase will randomize subjects to the texting~     intervention or to usual care.~   "
87636|NCT02419989|"~     Isolation of nontuberculous mycobacteria (NTM) from the sputum of individuals with CF is an~     increasingly common finding, and the lack of an evidenced-based approach to treatment of NTM~     disease has been identified as one of the greatest unmet needs within the CF community.~     Current evidence predicts that the prevalence of NTM will remain relatively high in the CF~     population. Approaches to NTM disease treatment differ widely between centers, and expected~     outcomes are not known. This study is observational and follows current best practices. The~     study will help define response to treatment, and collect relevant data associated with~     treatment of NTM disease to build a framework for future therapeutic trials.~   "
87637|NCT02419976|"~     The investigators will study a noninvasive no risk process by which the investigators can~     quickly screen and assess for fasting and non-fasting states in individuals scheduled for~     routine endoscopy.~   "
87638|NCT02419963|"~     Microbiota from fecal samples from IBS-D patients, in combination with vitamin D~     supplementation added to our 3-D immunocompetent intestinal models will establish a high~     fidelity disease model to achieve our long-term goal to understand the relationship between~     gut microbiome, vitamin D levels, host gene expression and IBS-D symptoms that could~     ultimately be used as a testing platform for treatment and prevention.~   "
87639|NCT02419950|"~     Mesh fixation is used to prevent recurrence in TEP to the potential cost of pain. The aim was~     to evaluate the impact of permanent fixation (PF) versus non-permanent fixation (N-PF) of~     mesh in TEP repair for a primary inguinal hernia regarding chronic pain. A cohort of patients~     were studied for pain interfering with sexual activety. The hyopthesis is that fixation~     causes pain.~   "
87640|NCT02419937|"~     Introduction: Interleukin 6 (IL-6) is a cytokine that has a pro-inflammatory effect on the~     immune system. In acute MI IL-6 levels rapidly increase in response to ischemia and~     inflammation. Tocilizumab is a humanized monoclonal antibody against the interleukin-6~     receptor (IL-6R). The use of tocilizumab within the first 24 hours of admission for acute MI~     could reduce 30 day mortality.~      Methods: This randomized, placebo controlled trial will assign subjects within 24 hours of~     admission to treatment with either 162 mg of tocilizumab subcutaneously once or placebo in~     addition to usual pharmacologic and interventional standard of care for acute MI (ST segment~     elevation MI or non-ST segment elevation MI).~      Outcomes: The primary outcome is difference in 30 day (plus/minus 5 days) occurrence of major~     adverse cardiac events (as defined later in this protocol) between placebo and Tocilizumab~     treated groups. Secondary outcomes to be assessed include length of hospitalization,~     readmission rates by day 30, CRP levels at 0 hours, 24 hours, 48 hours, and 30 days following~     treatment, and safety of Tocilizumab with focus on rates of known side effects.~   "
87641|NCT02419924|"~     Supporting the pelvic floor can reduce symptoms of constipation in patients with refractory~     constipation due to pelvic floor laxity and excessive perineal descent by means of a modified~     toilet seat, known as the Bottom's Up.~   "
87642|NCT02419911|"~     This is a post market, prospective, comparison study of the use of the FloShield Air System~     versus Clearify™ Visualization System (D-HELP) during laparoscopic surgery.~   "
87643|NCT02419898|"~     The aim of this feasibility study is to test recruitment of participants into Phase 1 of the~     study and then the re-recruitment and retention of participants in Phase 2 of the study. The~     investigators will also be assessing the acceptability of recruitment strategy and data~     collection to participants.~      The effect of pre-pregnancy factors (biophysical, genetic, socioeconomic, behavioural and~     psychological) on obstetric, cardiovascular, socioeconomic, behavioural and psychological~     outcomes will all be examined.~   "
87644|NCT02419885|"~     Fingertips facilitate smooth motor activity, precise sensation, and the delicate movement of~     the hands and have an aesthetic function. Fingertip injuries are defined as injuries~     occurring distal to the insertion of the flexor and extensor tendons. These injuries are one~     of the most common trauma injuries presented in acute care settings, accounting for~     approximately 4.8 million emergency department visits per year in the United States.(1)~     Fingertip amputations may not constitute the majority among these fingertip injuries but can~     have a complex spectrum of injury. In these cases, the reconstruction methodologies focus on~     preserving the digital length, ensuring adequate soft tissue coverage, preserving the nail~     structure, achieving a well-contoured and painless fingertip, and restoring durable and~     sensate skin.~      There are so many factor that influence the result of composite graft in distal finger tip~     amputation. Investigators will collected the data including the size of amputee , shape,~     level of amputation, mechanism of amputation, if hyperbaric oxygen therapy, operation~     procedures.~   "
87645|NCT02419872|"~     The study is to evaluate the percentage of patients with asthma or COPD achieving disease~     control~   "
87646|NCT02419859|"~     The purpose of the study is to obtain an assessment (efficacy, safety, and patient reported~     outcomes) of basal bolus insulin delivery with PaQ in insulin-using patients with type 2~     diabetes mellitus (T2DM).~   "
87647|NCT02419846|"~     This clinical trial studies an informed decision making intervention of screening for~     prostate cancer in predominantly African American participants. It also evaluates~     participants' knowledge about prostate cancer screening and to improve understanding. Using~     decision aids such as culturally sensitive written material, verbal information, and videos~     to educate patients about screening may increase patient participation and knowledge. This~     may increase confidence in participants' decisions. Raising awareness about prostate cancer~     in the communities may increase the participants' willingness to be screened for prostate~     cancer once they have learned about it.~   "
87660|NCT02419677|"~     The purpose of this study is to determine whether combining of radiofrequency ablation (RFA)~     and cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with~     colorectal cancer liver metastases (CRCLM).~   "
87674|NCT02419495|"~     Objectives:~      Primary Objective:~      To establish the safety and tolerability of Selinexor when given in combination with standard~     chemotherapy regimens.~      Secondary Objectives:~      To determine disease control and progression free survival of Selinexor administered with~     standard chemotherapy treatments.~      Exploratory Objectives:~      To determine the correlation of translational biomarkers To compare serial assessment of~     mutation status in biopsies obtained at baseline and progression after clinical response to~     combination therapy~   "
87648|NCT02419833|"~     In patients with acute myocardial infarction without ST-segment elevation on ECG (non-STEMI),~     previous studies have indicated that routine invasive treatment confers more benefit as~     compared to selective invasive approach. The benefits of routine invasive coronary~     intervention have been the most evident in patients with higher baseline risk profile.~     However, the question of optimal timing of routine invasive intervention remains unsolved.~      Immediate invasive intervention early after admission for non-STEMI may limit myocardial~     necrosis by securing the patency of the culprit coronary artery. Nevertheless, several~     previous studies reported higher levels of biomarkers of myocardial injury in patients~     undergoing early PCI. The question of earlier versus delayed procedure in non-STEMI patients~     may thus amount to whether the risk of intervening on an unstable plaque is greater than the~     risk of new ischemic events while waiting for the invasive procedure.~      The purpose of the present study is to compare effects of immediate coronary intervention,~     within 2 hours of admission, versus delayed intervention, within 2-72 hours after admission,~     in patients witn non-STEMI.~   "
87649|NCT02419820|"~     Randomized, Double-blind, Placebo-controlled, Dose-escalation, Repeated and Single Oral~     Dosing Phase I Study to Assess the Pharmacokinetics, Pharmacodynamics and Safety of APD791~     (Temanogrel) Co-administered with Aspirin and Clopidogrel.~   "
87650|NCT02419807|"~     This clinical trial will enroll up to 130 adult women with a confirmed diagnosis of clinical~     stage 1 or 2 breast cancer who are undergoing breast cancer surgery with lumpectomy or~     mastectomy and planned axillary sentinel node biopsy procedure. Patients will undergo~     lymphatic mapping with technetium Tc-99m (99mTc) sulfur colloid in accordance with routine~     clinical practice. Injections of 99mTc sulfur colloid will take place the afternoon prior to~     planned next morning surgery or on the morning of surgery. Patients will undergo~     lymphoscintigraphy in accordance with standard clinical practice.~      Immediately prior to operation, after the induction of anesthesia in the operating room, up~     to 1cc of 0.5% indocyanine green (ICG) solution will be injected subdermally close to the~     tumor or into the subareolar region after disinfection of the breast skin. ICG movement will~     be facilitated by manual massage and monitored with fluorescence imaging. ICG fluorescence~     will be elicited and detected by Photodynamic Eye (PDE) camera. The lymphatic drainage, made~     evident by the fluorescent dye, will be monitored in real time on a monitor. The fluorescence~     will be followed towards the armpit region (axilla) and time for the fluorescence to reach~     the axilla will be recorded. Following standard practice, an incision will be made in the~     armpit region. Fluorescent lymph nodes (ICG positive) will be localized and removed and~     analyzed by a pathologist. Node removal will continue until no residual fluorescence is~     visible in the axilla. Removed nodes will be tested for radioactivity using a standard~     gamma-detecting probe and the counts per minute will be recorded. Finally, the armpit region~     will be inspected with the gamma probe to determine if there are any residual radioactive~     nodes. Residual sentinel nodes (the first node to receive lymph from a tumor) will be~     removed. For the purposes of this study, the sentinel status of a node will be defined as~     being flagged as sentinel by either one or both of the ICG or 99mTc methods. The goal of the~     project is to confirm that axillary lymphatic mapping with ICG leads to similar nodes being~     labeled as sentinel as lymphatic mapping with 99mTc-labeled radiotracer.~   "
87651|NCT02419794|"~     The aim of this study is to clarify treatment status and clinical results of acute cerebral~     ischemia after approval of clot retriever in Japan, and also to obtain a basis for~     comparative studies.~   "
87652|NCT02419781|"~     The aim of this study is to clarify the efficacy of the endovascular treatment for acute~     ischemic stroke patients with large vessel occlusion and are not respond to intravenous~     recombinant tissue plasminogen activator (rt-PA) therapy.~   "
87653|NCT02419768|"~     Parkinson's disease (PD) is one of the most common neurodegenerative disorders. The~     parkinsonian gait is characterized by reducted stride length and gait speed, postural~     disorders (with a high risk of falling) and a modification of stride duration variability.~     This variability can be assessed by its magnitude (SD and CV) and its temporal organization~     (long-range autocorrelations). Healthy human gait presents with an interdependency between~     consecutive cycles that can span over hundreds of strides (long-range autocorrelations).~     Numerous observations plead for a relation between long-range autocorrelations and functional~     abilities of the system. Complementary to drugs, rehabilitation becomes an important way to~     treat PD.~      The aim of our study is to assess by a controlled, randomized, single blinded clinical study,~     the effect of physical exercise on stride duration variability, neurological impairments and~     walking abilities of parkinsonian patients.~      Physical exercise program will include 30 sessions spread over 15 weeks following the~     guidelines. Long-range correlations analysis, including the study of Hurst and α exponents,~     will be performed on a minimum of 512 consecutive cycles. Finally, the functional assessment~     of the parkinsonian patient will be done according to International Classification of~     Functioning Disability and Health (ICF).~   "
87654|NCT02419755|"~     This study will test the safety and effectiveness of adding bortezomib and vorinostat to~     other chemotherapy drugs commonly used to treat relapsed or refractory leukemia. Both drugs~     have been approved by the Food and Drug Administration (FDA) to treat other cancers in~     adults, but they have not yet been approved tor treatment younger patients with leukemia.~      PRIMARY OBJECTIVE~        -  To estimate the overall response rate of patients with MLL rearranged (MLLr) hematologic~          malignancies receiving bortezomib and vorinostat in combination with a chemotherapy~          backbone.~      SECONDARY OBJECTIVES~        -  Estimate event-free and overall-survival.~        -  Describe toxicities experienced by participants during treatment.~      OTHER PRESPECIFIED OBJECTIVES~        -  To identify all genomic lesions by comprehensive whole genome, exome and transcriptome~          sequencing on all patients.~        -  To compare minimal residual disease (MRD) results by three modalities: flow cytometry,~          polymerase chain reaction (PCR) and deep sequencing.~   "
87655|NCT02419742|"~     This is a prospective, Phase IV, multi-center, single arm, open-label, interventional study~     to evaluate the safety of trastuzumab for the treatment of human epidermal growth factor~     receptor 2 protein (HER2)-positive node positive or high risk node negative breast cancer~     participants with regimen consisting of doxorubicin and cyclophosphamide followed by either~     paclitaxel or docetaxel (AC-TH Regimen) or a regimen consisting of docetaxel and carboplatin~     (TCH Regimen) in Indian population.~   "
87656|NCT02419729|"~     Forty-five women will be included in a double-blind randomized trial in order to compare~     fractional CO2 laser treatment, local estrogen therapy and the combination of both treatments~     for Vulvovaginal Atrophy (VVA) and determine the efficacy and possible adverse effects CO2~     laser treatment.~   "
87657|NCT02419716|"~     This is a prospective longitudinal study to assess the impact of repeat Cologuard testing at~     3 years in average risk patients.~   "
87658|NCT02419703|"~     Registry collecting data on use of The STAR™ Tumor Ablation System.~   "
87675|NCT02419482|"~     The aim is to investigate whether 16 weeks of high intensity interval training, followed by~     36 weeks of home-based exercise, will improve menstrual frequency in women with Polycystic~     Ovary Syndrome (PCOS) compared with a non-exercising control group.~   "
87661|NCT02419664|"~     Title: Gallium (GA) -68-DOTATOC -PET (positron emission tomography) in the management of~     pituitary tumours Medical product: Ga-68-DOTATOC in PET/computer tomography (CT) Route of~     administration: Intravenously Diseases of interest: Pituitary tumours Aim: To study the~     detection of pituitary tumours with Ga-68-DOTATOC -PET (Ga-PET) and to correlate the tracer~     expression to somatostatin receptor (sst) occurrence Study design: Prospective non-randomised~     case-control study with open design with GA-PET before and after pituitary surgery in~     patients with pituitary tumours Study population: patients with acromegaly (n=10), Cushing's'~     disease of pituitary origin (n=10), TSH (thyreotropin) producing tumours (TSHomas) (n=5) and~     non-functioning pituitary adenomas (NFPA) (n=20) Number of patients: 45 Inclusion criteria:~     Adult man or woman (over 18 years) and naïve, unoperated pituitary tumour with growth hormone~     (GH) or adrenocorticotrophic hormone (ACTH)) or TSH production or NFPA without treatment with~     somatostatin analogues (SSA) or dopamine agonists.~      Exclusion criteria: Patient who may not attend to the protocol according to the investigators~     opinion. Pregnancy or lactating. Isolated prolactin producing tumours. Overproduction of~     gonadotropins. Carcinoids ie ectopic corticotrophin realising factor (CRF) production. Known~     or suspected allergy to the trial product or related products.~      Controls: Adult patients with Thyroid associated ophthalmopathy (TAO) before iv steroid~     infusion (part of another study see this protocol)- Study variables: Tumour detection, Tracer~     uptake as Standardised uptake value (SUV) max (SUVmax), SUV hotspot and SUV mean in regions~     of interests (ROIs) Time schedule: Recruitment of patients 2015-2017. Study termination 3~     years later~   "
87662|NCT02419651|"~     The purpose of this study is to compare the effectiveness of Tramadol and diclofenac in~     reducing pain during outpatient hysteroscopy. Women undergoing outpatient hysteroscopy in~     Cairo university will be divided into 3 groups, the first group will receive Tramadol 100 mg~     1 hour before the procedure, the second group will receive diclofenac 100mg 1 hour before the~     procedure and the third will receive a placebo. Pain will be assessed by a visual analogue~     scale~   "
87663|NCT02419638|"~     To compare two commonly used MS medications, IFN β-1a subcutaneous three times per week~     (Rebif) and oral twice daily dimethyl fumarate (Tecfidera), on mean number of new or~     enlarging T2 lesions at 6 months in adults with relapsing-remitting multiple sclerosis who~     are prescribed these medications and receive a 6 month MRI scan as standard of care.~   "
87664|NCT02419625|"~     Hepatitis E virus is a single-stranded positive-sense RNA virus with genome of approximately~     7.2kb in length. The HEV genome is capped at the 5' end followed by a small untranslated~     region of 27 nucleotides and polyadenalated at the 3' end preceded by another UTR of 65~     nucleotides . HEV has three open reading frames: ORF1, ORF2 and ORF3 that encode structural~     and non- structural proteins. ORF1 is the largest one, approximately 5,000 nt in length,~     located at the 5 ' end and encodes important proteins for the replication process~     (methyltransferase, papain-like cysteine protease, helicase, and RNA-dependent RNA~     polymerase). A noncoding, hypervariable region within ORF1 displays substantial genetic~     diversity; this region seems to modulate the efficiency of HEV replication. Notably, the~     differences in the genome size among different HEV strains are confined mainly to this region~     .ORF2 is located at the 3' end, encodes structural capsid proteins of 660 amino acids and~     contains three potential glycosylation sites. The ORF2 protein contains multiple immunogenic~     sites and neutralizing antibodies are directed against it al., .The essential region in the~     protein for immunogenicity is 452aa-617aa and the neutralizing epitopes have recently been~     shown to be conformational .ORF3 is located between the other two reading frames and encodes~     a small phosphoprotein of 123 amino acids. Its exact function has not been yet determined,~     however, multiple functions have been proposed. It is thought to interact with cellular~     mitogen-activated protein kinase phosphatase and other extracellular kinases, promoting cell~     survival through activation of intracellular signaling pathways .Moreover, the binding of the~     ORF3 encoded protein to host-specific proteins seems to influence the pathogenesis of HEV~     infections .A schematic drawing of the HEV genome is described in Figure 1 .~   "
87665|NCT02419612|"~     This clincial trial is evaluating if the co-administration of saxagliptin and dapagliflozin,~     in addition to metformin, results in better glycemic control, as measured by HbA1c, over a~     treatment period of 52 weeks, compared to the addition of glimepiride to metformin in~     subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control on Metformin~     Alone. We will compare the change from baseline in HbA1c achieved with saxagliptin, in~     co-administration with dapagliflozin, added to current background therapy with metformin~     compared to glimepiride added to current background therapy with metformin ≥1500 mg at Week~     52.~   "
87666|NCT02419599|"~     This study is a pilot trial investigating the effects of a high energy drink for children, in~     comparison to standard energy drink for children.~   "
87667|NCT02419586|"~     Gum chewing group will have less ileus and early resume of bowel motion than control group.~   "
87668|NCT02419573|"~     The primary objective of the trial is to determine if 72-hour survival after out-of-hospital~     cardiac arrest (OHCA) is improved with initial endotracheal intubation (ETI) over initial~     laryngeal tube (LT) airway management strategies.~   "
87669|NCT02419560|"~     The purpose of this study is to determine the optimal dosing scheme for the combination of~     ibrutinib with ABT-199 for the treatment of relapsed or refractory mantle cell lymphoma~     (MCL).~   "
87670|NCT02419547|"~     This research study is being done to see whether general anesthesia (GA) affects our ability~     to start ventricular tachycardia (VT) during an VT ablation procedure.~      Data collected during this research study will help electrophysiologists and~     anesthesiologists to make the best decisions about the best anesthetic conditions to use to~     perform VT ablations.~      This research study is a pilot study. Pilot studies are done on a small group of subjects~     to learn if a larger study would be useful.~   "
87671|NCT02419534|"~     To evaluate whether effectively treating anal fissure-associated constipation using oral PEG~     alone can eliminate the inconvenience of add topical agent such as DTZ. As previous studies~     have shown the topical agent are more effective in treating anal fissure when combined with~     less effective laxatives~   "
87672|NCT02419521|"~     The purpose of this trial is to assess the safety and efficacy of the Resolute Onyx~     Zotarolimus-Eluting Coronary Stent System for the treatment of de novo lesions in native~     coronary arteries with a reference vessel diameter of 2.25 mm to 4.2 mm.~   "
87673|NCT02419508|"~     The purpose of this study is to evaluate the additive intraocular pressure (IOP) lowering~     effect of brinzolamide 1%/brimonidine 0.2% (dosed twice per day (BID)) when added to a PGA in~     patients with open-angle glaucoma or ocular hypertension.~   "
87693|NCT02419248|"~     Check the safety under normal conditions of use through the verification of emergence signs~     of irritability and sensitisation of the genital mucosa.~   "
87676|NCT02419469|"~     The goal of this clinical research study is to learn if a chemotherapy combination called~     augmented Berlin-Frankfurt-Munster (BFM), when also combined with ofatumumab or rituximab,~     can help to control precursor-B ALL or LL in patients who are 12-30 years of age. The safety~     of these drug combinations will also be studied.~      Augmented BFM is made up of daunorubicin, vincristine, prednisone, dexamethasone, PEG~     asparaginase, and methotrexate.~   "
87677|NCT02419456|"~     Intravaginal rings (IVRs) may offer an ideal way to deliver antiretroviral (ARV) drugs to~     prevent HIV infection. This study will evaluate the pharmacokinetics and safety of two IVRs~     containing different doses of a combination of two HIV ARV drugs, vicriviroc (VCV) (MK-4176)~     and MK-2048, in healthy, HIV-uninfected women.~   "
87678|NCT02419443|"~     A common source of morbidity after IHR is chronic groin pain(CGP), usually defined as pain~     lasting longer than 3 months. Gabapentin is an anticonvulsant that is also of benefit in the~     treatment of neuropathic pain. We propose a randomized, double-blind, placebo controlled~     study of the effect of gabapentin on CGP after IHR. Their pain will be assessed with a visual~     analogue scale. For those reporting pain, the need for pain medication, or other treatment,~     and the effect of pain on their quality of life will be recorded.~   "
87679|NCT02419430|"~     The investigators aim to evaluate the Mindfulness Based Resilience Training (MBRT)~     intervention for Mayo Clinic employees in order to provide evidence for improved ability to~     cope with stress and decreased work-related burnout and stress-related symptoms as a result~     of MBRT training. In addition, the investigators aim to compare the effects of MBRT +~     smartphone sleep feedback, a smartphone resilience intervention + smartphone sleep feedback,~     or waitlist control +smartphone sleep feedback in a randomized clinical trial in a sample of~     75 Mayo Clinic employees.~   "
87680|NCT02419417|"~     The purpose of this study is to determine the safety, tolerability, pharmacokinetics, and~     pharmacodynamics of BMS-986158 in subjects with select advanced cancers~   "
87681|NCT02419404|"~     The investigators hypothesize that analysis of blood pressure will allow doctors to predict~     whether or not blood flow from the heart (cardiac output) increases after intravenous fluids~     are given.~   "
87682|NCT02419391|"~     A total of 63 subjects will be recruited into three groups (18 subjects per group will~     receive MVA BN RSV vaccine and three subjects per group will receive placebo). Liquid frozen~     suspension of MVA BN RSV.~      Each subject will receive two vaccinations with either MVA-BN RSV vaccine 1 x 108 TCID50 per~     0.5 ml, 1 x 107 TCID50 per 0.5 ml or with placebo.~   "
87683|NCT02419378|"~     Alemtuzumab is the active agent of a drug called Lemtrada®. In the European Union, Lemtrada®~     is approved for the treatment of a particular form of multiple sclerosis (the so called~     relapsing remitting form). The excellent efficacy of the drug justifies its administration~     albeit a high risk of considerable side effects. In this context, so called secondary~     (occurring after the administration of Lemtrada®) autoimmune diseases are of particular~     importance. In these diseases the immune system acts against structures of the body itself;~     the reasons are still unknown. Autoimmune diseases may even occur several years after~     treatment with Lemtrada®. Therefore, patients who once received the drug need to undergo~     intensive long term health monitoring.~      This study aims to elucidate which mechanisms cause to the positive and negative effects of~     Lemtrada®.~      The study includes patients only, who suffer from multiple sclerosis and are indicated to be~     treated with Lemtrada®. All patients receive the drug according to the official~     recommendations.~   "
87684|NCT02419365|"~     The purpose of the international prospective PCD Patient Registry is to systematically~     measure, survey and compare different aspects of PCD manifestation, course and treatment, to~     provide data for epidemiological research and to identify special patient groups suitable for~     multi-center trials.~   "
87685|NCT02419352|"~     Post operative cognitive dysfunction (POCD) is recognized as a frequent complication after~     both cardiac and non cardiac surgery, affecting approximately 1/3 of the patients. The aim of~     this study is to examine the possible effect of the novel reversal agent sugammadex versus~     neostigmine/ atropine combination on cognitive function of adult patients after elective~     surgery during the early post operative period as well as at discharge.~   "
87686|NCT02419339|"~     Prospective multicenter observational study of early infancy ureteral reimplantation for~     distal ureteral obstruction.~      The study is an observation study since the investigators will not assign specific~     interventions to the subjects of the study.~      The purpose of the study is to describe the surgical outcomes of early infancy ureteral~     reimplantation. Infants under 6 months of age with unilateral obstructed distal ureter, no~     other urologic pathologic and a normal contralateral kidney who have been recommended a~     ureteral reimplant by their pediatric urologist are eligible for the study. Patients that~     consent for the study will be prospectively followed for 1 year to record the outcomes of the~     surgery.~   "
87687|NCT02419326|"~     The purpose of this study is to test the feasibility, acceptability, and preliminary efficacy~     of a novel couple-based intervention for binge-eating disorder (BED).~   "
87688|NCT02419313|"~     The scientific aim of this study is to investigate the efficacy and safety of~     incobotulinumtoxinA (Xeomin-Merz Pharmaceuticals) in the tremor of Parkinson‟s disease. Our~     hypothesis is that injection of Xeomin into the muscles of arm, forearm and hand decreases~     the tremor amplitude and frequency leading to improvement of the patient‟s function.~   "
87689|NCT02419300|"~     Value of pelvi- abdominal ultrasound and Doppler in diagnosis of retained products of~     conception after second trimester miscarriage to select who will benefit from surgical~     evacuations or conservative management.~   "
87690|NCT02419287|"~     The purpose of this study is to determine the response and the duration of it in patients~     affected by ALK+ lymphoma that are resistant or refractory to standard cytotoxic treatment~     that will be treated with crizotinib.~   "
87691|NCT02419274|"~     Deep Phenotyping of adult asthma patients:~        -  severity from mild to severe~        -  both atopic and non-atopic~        -  both childhood and adult onset~        -  both smokers and non-smokers~        -  corresponding pediatric cohort (Pediatric Arm of DZL All Age Asthma Cohort) with~          equivalent SOPs regarding collection of biomaterial and clinical data incl. lung~          function, further processing of biomaterial and further analyses~   "
87692|NCT02419261|"~     Assessment of sensory and motor blockade of adductor canal blockade performed for anterior~     cruciate ligament repair in comparison with femoral nerve blockade.~   "
87694|NCT02419235|"~     Refractory hypertension is defined as failure to reach goal blood pressure control in~     patients who are adherent to full doses of the appropriate drug regime. Hypertension results~     in 7.6 million deaths annually and 92 million disability adjusted years worldwide, making it~     the number one attributable risk for death throughout the world. Conventional treatment~     involves lifestyle modification and antihypertensive drug therapy; however blood pressure can~     remain uncontrolled despite these treatment options. Previous studies have demonstrated a~     reduction in blood pressure in adults with essential hypertension with the use of various~     homoeopathic complexes. There has been no research done to date on the effect of the~     homoeopathic combination of Amylenum nitrosum 6cH, Crataegus oxyacantha 6cH, Natrum~     muriaticum 6cH and Scutellaria lateriflora 6cH in adults with refractory hypertension.~      The aim of the study is to investigate the effect of a homoeopathic complex Amylenum nitrosum~     6cH, Crataegus oxyacantha 6cH, Natrum muriaticum 6cH and Scutellaria lateriflora 6cH on blood~     pressure in adults with refractory hypertension, by means of blood pressure readings.~   "
87695|NCT02419222|"~     This research project is a study designed to address both motor and cognitive changes after~     stroke. Treatment for SN is elusive however there is support for prism adaptation treatment~     (PAT). Therapists need to know more about the effects of this treatment and if it is feasible~     in a group of stroke survivors with multiple lesions because these are the patients they are~     treating in the clinical setting. Also, it has not been investigated that using PAT to~     remediate SN will then as a result increase spontaneous UE movement of the weak limb.~   "
87696|NCT02419209|"~     Low sexual desire, or decreased libido, is one of the most prevalent sexual complaints in~     females. Menopause is defined as the physiologic cessation of menses brought on by a decrease~     in ovarian function and is established once menses have been absent for at least twelve~     months. Perimenopause refers to the period shortly before as well as the twelve months after~     the last menstrual period. The duration of perimenopause varies greatly and signs and~     symptoms usually begin appearing during a woman's forties. A longitudinal study conducted in~     Seattle showed that women experienced a significant reduction in sexual desire during the~     late perimenopausal and early postmenopausal stages, with the biggest decline in sexual~     desire occurring from three years prior to two years after the final menstrual period.~     Despite being a prevalent female complaint, currently no standard treatment for low sexual~     desire exists. Homeopathy may offer a safe and effective solution for this common problem,~     however limited research has been conducted to date.~      The aim of this study is to explore the effect of individualised homeopathic treatment on low~     sexual desire in perimenopausal females using detailed case studies, the desire and arousal~     subscales of the Female Sexual Function Index (FSFI) as well as Item 13 of the Female Sexual~     Distress Scale - Revised (FSDS-R).~   "
87697|NCT02419196|"~     Perioperative changes in regional ventilation by pulmonary electrical impedance tomography~     and spirometry will be investigated in patients at risk for postoperative pulmonary~     complications. Those patients undergo abdominal and limb operations. In a pilot study arm~     electrical impedance tomography is tested in patients receiving osteosynthesis of serial rib~     fractures.~   "
87698|NCT02419183|"~     The purpose of this study is to evaluate the psychometric properties of a Self-administered~     Memory Screening Test with Automated Reporting (SAMSTAR) adapted from the Rey Auditory Verbal~     Learning Test (RAVLT) in normal control (NC) participants and participants with Mild~     Cognitive Impairment (MCI) against a standard version of the RAVLT test, administered by an~     examiner under the same conditions.~   "
87699|NCT02419170|"~     The purpose of this research study is to study the safety and immune response of people who~     receive a personalized dendritic cell vaccine with the intention of stimulating the immune~     system to react to lung cancer cells.~   "
87700|NCT02419157|"~     The purpose of this study is to evaluate the clinical effectiveness of non-carious cervical~     lesions (NCCLs) restored with two self-etching adhesive systems applied with or without~     selective enamel etching.~   "
87701|NCT02419144|"~     This study will test an intervention designed to change oral health norms and reduce~     disparities in oral health among vulnerable adults residing in publicly funded senior housing~     in Central Connecticut. The intervention model is based on Fishbein modified theory of~     reasoned action operationalized through Adapted Motivational Interviewing and Practice to~     Mastery. The intervention includes two components: 1) a face to face administration of the~     Adapted Motivational Interviewing and Practice to Mastery, a participatory counseling model,~     and 2) a targeted building level campaign consisting of three half-day oral health events~     with skills development through practice to mastery to parallel the individual intervention,~     all based on the study's conceptual model. The study uses a modified fractional factorial~     design to evaluate the face to face and campaign components separately and in different~     additive sequences. Six buildings will be paired in three dyads. The buildings in each dyad~     will be randomized to either having the Adapted Motivational Interviewing and Practice to~     Mastery intervention first followed by campaigns or to having the campaigns first followed by~     Adapted Motivational Interviewing and Practice to Mastery. Seventy-five residents will be~     recruited in each building for a total of 450 participants. There will be four assessments:~        1. T0 will include a survey, oral hygiene skills assessment and clinical assessment of the~          Gingival Index and Plaque Score. The survey will provide data on the conceptual domains~          that are the target of the tailored intervention~        2. T1 will follow the AMI-PM or CA+PM (depending on condition) and will include the survey,~          oral hygiene skills assessment and clinical assessment of the Gingival Index and Plaque~          Score. This assessment will occur 1-2 months after the initial intervention~        3. T2 will follow the AMI-PM or CA+PM and will include the survey, oral hygiene skills~          assessment and clinical assessment of the Gingival Index and Plaque Score. This~          assessment will occur 6 months after the initial intervention~        4. T3 will include oral hygiene skills assessment and clinical assessment of the Gingival~          Index and Plaque Score. This will occur 15-18 months after study entry. We will use~          general linear mixed models (GLMM) or general estimating equations (GEE), respectively,~          to fit a model with intervention and period effects using the MIXED procedure in SAS.~   "
87702|NCT02419131|"~     The overall purpose of the study is to compare two talk therapies (Clinic-Based Cognitive~     Behavioral Therapy and Cognitive Processing Therapy-Cognitive Only) for the treatment of~     posttraumatic headache (PTHA) and co-morbid posttraumatic stress (PTS). The researchers hope~     to learn if a non-medication, cognitive-behavioral treatment can result in noticeable~     reductions in PTHA intensity/severity and frequency as well as PTS symptom severity.~   "
87703|NCT02419118|"~     Daratumumab is a new treatment for patients with myeloma. While many patients benefit from~     this treatment some do not and the mechanism(s) of failure are poorly understood. This study~     aims to clarify aspects of resistance to treatment with daratumumab in order to improve~     patient outcomes in the future.~   "
87704|NCT02419105|"~     The overall purpose of this study is to test the individual and combined effect of~     transdermal testosterone and/or Vitamin D in reducing fall risk and improve function in~     pre-frail hypogonadal senior men.~   "
87831|NCT02417428|"~     The main objective of this study is to determine if oral supplementation of Citrulline, when~     combined with HIIT, can produce significant changes in body composition, muscle quality,~     muscle metabolism and functional capacity in older obese men and women .~      The investigators hypothesize that Citrulline combined with HIIT will be more beneficial than~     HIIT alone which will be more beneficial than citrulline alone which will be more beneficial~     than placebo alone in obese elderly men and women .~   "
87705|NCT02419092|"~     UPDATED May 2016:~      Originally the study design included investigation of the effects of the bioactive compound~     resveratrol compared to placebo tablets and to CPAP treatment. Due to fewer subjects having~     OSA than estimated by pre-study and, therefore, difficulties in the recruiting process the~     investigators have found it necessary to descale the study design. Hence, we have~     discontinued the resveratrol and CPAP intervention and will focus on the cross-sectional~     investigation of metabolic changes in subjects with and without OSA and the effect of weight~     loss after bariatric surgery on inflammation, OSA severity, metabolism and arterial~     stiffness.~      Obstructive sleep apnea (OSA) is a common disorder especially among obese individuals and~     patients with type 2 diabetes. OSA is associated with an increased morbidity and mortality.~      Continuous positive airway pressure (CPAP) is the standard treatment. Also weight loss is~     known to reduce the severity of OSA, especially bariatric surgery has proven effective~     because of the massive weight loss.~      The investigators hypothesize that OSA via pro-inflammatory responses in various tissues~     causes low-grade inflammation which ultimately induce the associated co-morbidities. The~     investigators hypothesize that massive weight loss after bariatric surgery have beneficial~     effects on severity of OSA, inflammatory status and improves insulin sensitivity.~   "
87706|NCT02419066|"~     Determine the level, patterns, and correlates of objectively measured ART adherence in early~     and advanced-stage disease, among pregnant and non-pregnant individuals, to determine the~     need and nature of interventions to support early ART adherence in Uganda and South Africa~   "
87707|NCT02419053|"~     The purpose of this study is to see if the surgical safety checklist is associated with a~     reduction in perioperative complications for children undergoing surgery in Ontario, Canada.~   "
87708|NCT02419040|"~     The purpose of this study is to determine whether the combination of removal of the~     calcification in calcific tendinitis of the shoulder (supraspinatus and/or infraspinatus~     tendon) by aspiration with a needle and syringe (barbotage) and a corticosteroid injection is~     more effective than corticosteroid or sham injection alone.~   "
87709|NCT02419027|"~     A Multi-center, Randomized, Double-blinded, Placebo-controlled Human Study to Evaluate the~     Efficacy and Safety of probiotic mixture(®GI Flora) in Subjects with Irritable Bowel~     Syndrome.~      Regimen: 6 probiotics mixture >10^9/D for 8 weeks~      Primary variable: visual analogue scale(VAS) assessment for abdominal pain~      Secondary variable:~        1. change of VAS score for abdominal pain/discomfort after 4/8-week treatment~        2. daily symptom score for bloating, defecation discomfort(strain/urgency/incomplete~          evacuation), flatulence , feces shape, frequency of bowel movements~   "
87710|NCT02419014|"~     The purpose of this study is to assess the feasibility and effectiveness of Cranial~     Electrical Stimulation (CES) therapy in treating symptoms of Restless Legs Syndrome (RLS).~     Participants will be randomly assigned to one of three groups, a usual care (control group),~     an active CES device group and a sham (inactive) CES device group. Those who are enrolled in~     one of the device groups will not know which type of device they have (blinding). Those~     enrolled in the usual care group and sham groups will ultimately have the option to use the~     active device after they complete the study. Study length for participants is 8 weeks.~   "
87711|NCT02419001|"~     A Phase 1b/2a, Randomized, Multi-Center, Open-Label, Fixed-Sequence Study to Evaluate the~     Effect of Oral SYN-004 on the Pharmacokinetics of Intravenous Ceftriaxone in Healthy Adult~     Subjects with a Functioning Ileostomy.~   "
87712|NCT02418988|"~     Treatment options for advanced hepatocellular carcinoma (HCC) are limited due to patients'~     poor condition, advanced tumor, concomitant intra- and extra-liver diseases, and resistance~     to both chemo- and radio-therapy. Trans-catheter embolization (TAE) or Trans-catheter~     chemo-embolization (TACE) is the most widely used locoregional treatment for advanced HCC.~     But no solid evidences support the beneficial effect of the chemotherapy in TACE. Many~     advanced HCC patients also can't tolerate the locoregional chemotherapy. The p53 gene has~     multiple anticancer functions and does not have any of the immune-inhibitory effects of~     chemo- or radio-therapy. The objectives of this study are to investigate the efficacy and~     safety usingTAE plus recombinant adenoviral human p53 gene (rAd-p53) in treatment of advanced~     HCC.~   "
87713|NCT02418975|"~     Pre-operative weight loss can reduce the risk intra- and post-operative complications but no~     optimal pre-operative weight loss strategy has been investigated. Very-low-calorie diets~     (VLCDs) were proven to results in higher metabolic improvements in the short-term than~     balanced, hypocaloric diets. Therefore, the aim of the study is to investigate whether a VLCD~     results in lower intra-and post-operative complications compared to a hypocaloric diet.~     However, to achieve a optimal compliance in patients having experienced multiple dietary~     intervention failures, administration of the intervention will be performed by the enteral~     route using a naso-gastric feeding tube.~   "
87714|NCT02418962|"~     This is a single center, randomized, placebo-controlled, double-blind trial to assess the~     safety and immunogenicity of PfSPZ Vaccine administered by direct venous inoculation (DVI).~      The study to be conducted in Baney District, Bioko Island, Equatorial Guinea (EG), will be to~     establish whether three doses of the higher regimen - three doses of 2.7x10^5 PfSPZ of the~     PfSPZ Vaccine administered at 8 week intervals - is as well-tolerated and efficacious in~     malaria exposed African adults as the five dose regimens. Specifically, the trial will~     address the following objectives: is the three dose regimen:~        1. Safe and well tolerated in Equatoguinean (EG) adults.~        2. As immunogenic in EG adults as is the five-dose regimen of 1.35x10^5 PfSPZ in Tanzanian~          and U.S. adults or as three-, four- and five-dose regimens of 2.7x10^5 PfSPZ being~          tested in Tanzanian, Malian and U.S. adults.~      In addition, as an exploratory objective, the volunteers in the EG trial will be followed~     longitudinally to measure the incidence of malaria during the initial six months following~     immunization, providing a preliminary assessment of efficacy.~   "
87715|NCT02418949|"~     This study evaluates a new rehabilitation approach for stroke survivors in the chronic phase~     of recovery in which the combination of drug therapy (cyproheptadine) and active movement~     practice (AMP) is used to encourage increased voluntary muscle control and strength.~   "
87716|NCT02418936|"~     The purpose of this study is to develop and applicate two new genetic deafness gene~     diagnostic kit for Waardenburg syndrome and large vestibular aquduct syndrome.~   "
87717|NCT02418923|"~     This study compares the results of current standard coagulation measurement devices to the~     Quantra System, a new device, using small amount of extra blood obtained during routine blood~     draws in neurosurgery patients.~   "
87718|NCT02418910|"~     The goal of this project is to complete the development of a patient-centered software system~     and mobile app to assist in managing bipolar disorder. In Phase I, the investigators~     developed a novel computational tool known as KIOS. Based on concepts from nonlinear systems~     (chaos) theory, KIOS tracks multiple interacting symptoms to determine the precise state of a~     BD patient. Once the patient's state is identified and the trajectory of the patient is~     established, KIOS produces advice specific to the patient's condition to help manage the~     course of the disease. To demonstrate the usability of the software, KIOS was converted to an~     online tool with mobile access. Twenty bipolar patients evaluated KIOS in a twelve week field~     trial. No technical problems with the software were observed and results showed that patients~     had significantly more reductions in symptom severity than increases. The development of this~     innovative tool to help patients self- manage BD has the potential to have a profound impact~     on public health and achieve significant commercial success.~   "
87719|NCT02418897|"~     This pilot study will evaluate for the presence of neuromuscular junction (NMJ) defect in~     women with motor fatigue in multiple sclerosis by Single Fiber Electromyography (SFEMG) using~     the concentric needle electrode.~   "
87720|NCT02418884|"~     This study is designed to validate the hypothesis that the treatment of rosuvastatin could~     increase the score of Calcification of Coronary artery(CAC) density in coronary artery~     disease(CAD) patients with diabetes mellitus.CAD patients with diabetes who confirmed CAC~     will receive rosuvastatin (20mg/d) therapy for 24 months.~   "
87721|NCT02418871|"~     The objective of this study is to evaluate the clinical outcomes of an accommodating~     intraocular lens (AIOL) designed to provide distance, intermediate, and near vision in~     patients undergoing cataract extraction and intraocular lens implantation using an improved~     injector system.~   "
87722|NCT02418858|"~     Recently, there has been increasing interest in performing DBS under general anesthesia,~     where the stimulated targets are located anatomically (i.e. on MRI) rather than~     physiologically via microelectrode recordings and intra-operative test stimulation. This~     technology has been termed asleep DBS and is performed with the patient under general~     anesthesia. Intraoperative imaging is utilized to verify the stereotactic accuracy of DBS~     electrodes placement at the time of surgery. Because stereotactic accuracy (and surgical~     safety) is the surgical endpoint, there is no need for the patient to be awake during the~     procedure.~   "
87723|NCT02418845|"~     The purpose of this clinical trial is to test the safety and efficacy of the oral~     investigational new drug, SYM-1219 for the treatment of bacterial vaginosis.~   "
87724|NCT02418832|"~     Needle aspiration of the epididymis causes rupture and irreversible damage to the duct.~     Recurring punctures and needle aspirations of fluid and tissue during Testicular Fine Needle~     Aspiration (TEFNA) procedure cause irreparable injury and loss of part of the testis'~     tubules. The hypothesis of this research is that production of sperm from the testis will be~     improved due to ultrasonically guided Rete Testis needle aspiration. In cases of Obstructive~     Azoospermia, the Rete Testis is expected to contain a large number of sperm cells. In cases~     of Non-Obstructive Azoospermia, the investigators can expect to produce sperm cells from~     aspiration of the Rete Testis, which drains all of the testis' tubules. Furthermore,~     catheterization of the Rete Testis will allow for the drainage of all testes tubules and for~     the production of sperm cells created locally in some of the tubules or in parts of them.~      The potential advantage of needle aspiration from the Rete Testis is that the procedure will~     allow for the aspiration from all the testes tubules, as opposed to the standard method of~     sperm cells production from the testis which samples only some of the tubules. Therefore, it~     is expected that the procedure suggested in this research will be more efficient than the~     standard procedures currently in practice. An additional advantage to this procedure is that~     puncture and aspiration of the tubule network is not expected to block the drainage from the~     testis, as is the case in aspiration of the epididymis, and it is also not expected to damage~     the tubules, as is the case in TEFNA and in TESE.~   "
87725|NCT02418819|"~     This study is designed to investigate the safety, tolerability pharmacokinetics and~     pharmacodynamic effects of PF-06412562 following multiple dose administration as MR tablets~     in subjects with schizophrenia.~   "
87726|NCT02418806|"~     An experimental study designed to test the effectiveness of a psychological intervention~     based on group therapy for the caregivers of Alzheimer's disease patients. The intervention~     consists of 16 sessions of a cognitive-behavioral psychological group therapy. This study~     aims to demonstrate that Alzheimer's patients' caregivers can decrease the feelings of burden~     after been involved in a group therapy.~   "
87727|NCT02418793|"~     The purpose of the current Phase 1/2a single dose, dose-escalating study is to evaluate the~     acute safety, pharmacokinetics (PK) and pharmacodynamics (PD) properties of MOD-5014 in adult~     subjects with moderate/severe congenital hemophilia A or B. This will be a single-dose, open~     label, dose-escalating study. Each dose cohort will be concluded by a safety review,~     following which escalation to the next dose cohort will be approved.~   "
87728|NCT02418780|"~     The purpose of this feasibility study is to preliminarily evaluate the effects of Tai Chi - a~     mind-body exercise - on motor and cognitive function as well as quality of life in~     individuals recently diagnosed with Parkinson's disease (PD).~   "
87729|NCT02418767|"~     The study is a Phase 1, randomized, double-blind, vehicle-controlled, single-dose, three dose~     levels study in healthy Caucasian and Japanese male volunteers.~      Following a 4-week screening period, eligible male subjects will be stratified by ethnic~     group and will be randomized to one of six groups. On dosing day, designated as Day 1, each~     subject will receive single SC injection of study medication according to group allocation~     and will be followed up for a month for safety monitoring.~   "
87730|NCT02418754|"~     The primary objective of the study is to explore the effect of REGN2176-3 on the Early~     Treatment Diabetic Retinopathy Scale (ETDRS) best-corrected visual acuity (BCVA) in patients~     with neovascular age-related macular degeneration (AMD), compared to intravitreal aflibercept~     injection (IAI) monotherapy.~   "
87731|NCT02418741|"~     The purpose of this study is to investigate whether degree of neck flexion affect on~     laryngeal view and discomfort during endotracheal intubation in adult patients.~   "
87895|NCT02416596|"~     The aim of the present study is to evaluate the impact of hysteroscopy prior to starting the~     IVF (in vitro fertilisation) cycle on treatment outcome in women with unexplained primary~     infertility.~   "
87732|NCT02418728|"~     In the developing countries, obesity prevalence is on a dramatic rise. Obesity is related to~     co-morbidities and as a result, obesity significantly shortens life expectancy and lowers~     quality of life. To prevent this, participation in exercise or training programs is~     absolutely necessary, in order to generate adipose tissue mass loss. The amount of adipose~     tissue mass loss is, amongst others, dependent on lipolysis which is under endocrine~     regulation by, mainly, catecholamines, insulin and atrial natriuretic peptide. However, large~     variations in adipose tissue mass loss and gain are likely in obese subjects, possibly due to~     a decreased lipolytic effect of these hormones (as was shown for catecholamines in the~     subcutaneous adipose tissue of obese subjects). However, the relative contribution of atrial~     natriuretic peptide in the lipolytic process remains elusive, particularly in subjects with~     obesity, which show an increased plasma expression of atrial natriuretic peptide.~      The aim of the present study is to observe the contribution of atrial natriuretic peptide in~     the subcutaneous adipose tissue of obese subjects. This will be tested by measurements of~     extracellular glycerol levels (by microdialysis) in the subcutaneous adipose tissue in situ~     at rest and during endurance exercise under local beta- and alpha-blockade.~      Eventually, the knowledge gained from this research will contribute to the optimization of~     exercise programs for people with obesity.~   "
87733|NCT02418715|"~     The aim of this study was to investigate the effects of water-based exercises on lipid~     profile (LP) and lipoprotein lipase (LPL) levels in premenopausal dyslipidemic women.~      It was hypothesized that a water-based aerobic interval-training period would decrease plasma~     concentrations of atherogenic lipoproteins and concomitantly increase HDL and LPL levels, as~     well as maximal oxygen uptake (VO2max) values.~   "
87734|NCT02418702|"~     Depression treatment typically is slow acting. Patients presenting with acute suicidality~     have few immediate treatment options. However, sub-anesthetic doses of ketamine have been now~     widely tested as a rapid-acting treatment for depression. Gregory Larkin et al at Yale showed~     this could be applied to suicidal patients, with 14 of 15 participants showing remission of~     suicidal thinking within 40 min of the administration of ketamine, with 13 showing lasting~     remission out to 10 days. No serious side effects were reported. This project proposes to~     conduct a randomized, placebo-controlled trial of this, same intervention in military~     patients recently hospitalized for suicidal thinking. After being assessed, and giving~     informed consent, participants would receive 0.2mg/kg ketamine or placebo. Their suicidal~     thinking, depression, and other symptoms would be monitored acutely for 240 min after drug~     infusion, and the for lasting changes the next day, at hospital discharge, 2 weeks, and 10~     weeks. Potential adverse events will be monitored via the electronic medical record for up to~     a year.~   "
87735|NCT02418689|"~     The purpose of this study is to evaluate the efficacy and safety of novel pan-HER inhibitor,~     NOV120101 (Poziotinib), in HER2-overexpressed recurrent stage IV breast cancer patients who~     received at least 2 prior HER2-directed regimens.~   "
87736|NCT02418676|"~     The coprecipitation method was used to prepare hydroxypropyl-beta-cyclodextrin complexed with~     insulin (HPβCD-I) by mixing insulin with hydroxypropyl-beta-cyclodextrin (HPβCD) in the molar~     ratio of 1:5 with the addition of 10 mL of purified water for every 100 mg of the complex.~     After complete dissolution of the material, the mixture was stirred for 30 min at room~     temperature (25°C), then left to rest for 60 min and lyophilized.~      The gel was prepared by dispersing the Carbopol 940® polymer in a known amount of purified~     water. Under mild heating the methylparaben (0.02%, w/v), propylparaben (0.01%, w/v) and~     propylene glycol were dissolved and incorporated in the dispersion of Carbopol 940® and left~     to rest for a period of 12h. After this time, the prepared gel was stirred and pH corrected~     to a range of 5.0 to 7.0 with triethanolamine. A set amount of insulin and the HPβCD-I~     complex were incorporated into the control gel for the preparation of other formulations.~      A randomized, double-blind, prospective clinical trial was conducted from March 2013 to April~     2014 at the Hospital Universitário Regional de Maringá (HUM), Paraná, Brazil, in order to~     determine the safety and efficacy of gel in patients hospitalized in the Intensive Care Unit.~      Hyperglycemic volunteers and those with pressure ulcers other than grade II were excluded~     from the study. Grade II pressure ulcers were selected as they are a superficial lesion, with~     little tissue loss, and allow easy visualization of healing.~      A letter of free and informed consent was obtained. The study was conducted with each patient~     for a period of 15 days.~      The volunteers were divided equally into three groups A, B and C, with each group being~     formed by five volunteers (n=5). Group A was randomly selected for treatment with gel with~     HPβCD-I complex, group B for treatment with gel with insulin, and group C with the control~     gel.~      Blood glucose tests were performed in order to assess whether the insulin complexed or~     otherwise with HPβCD could cause an increase in the rate of insulin in the blood in patients,~     leading to hypoglycemia.~      An identical standardized procedure for gel placement was used for all patients. Initially,~     the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was~     measured and photographed, as the ruler included the date and the initials of the patient.~     After measuring, a quantity of 5 grams of gel was placed on the pressure ulcer and covered~     with sterile gauze and a transparent film.~      The curative was changed once a day during the treatment period, unless there was leakage of~     fluid, contamination, or signs of infection. Every three days the pressure ulcers of all~     patients were measured and photographed again, resulting in a total of six measurements per~     patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and~     any kind of irritation. At the end of this stage, the properly gathered study data was~     interpreted using the analysis software Mobile Wound Analyzer® (MOWA).~      Data was evaluated by variance analysis (ANOVA), and means were compared with the Tukey test~     (p < 0.05) using the software Statistica 8.0/2008 (Stat Soft Inc., Tulsa, USA).~      Mixed model repeated measures methodology with some covariance structures was adopted for~     statistical analysis of the clinical trial (p < 0.05). The Statistical Analysis System (SAS)~     for Windows, version 9.3 (SAS Inc., Chicago, IL) program was used for statistical analysis.~   "
87737|NCT02418663|"~     The aim of this study is to determine the prevalence of Fluid Responsiveness (FR) (SV~     increases by at least 15% after Volume Expansion, VE) in postoperative patients admitted on a~     surgical ward after elective abdominal, thoracic and esophageal surgery~   "
87738|NCT02418650|"~     A study to investigate absolute bioavailability of ODM-201 and to determine the mass balance~     and routes of excretion of ODM-201 in healthy volunteers.~   "
87739|NCT02418637|"~     Test the feasibility of performing worksite screening of Hypertension, Diabetes and~     Hyperlipidemia for six months~   "
87740|NCT02418624|"~     A phase I trial to determine the recommended phase two dose of the combination of carboplatin~     and olaparib.~   "
87741|NCT02418598|"~     The purpose of this study is to evaluate the safety, efficacy of intra-putaminal infusion of~     AAV-hAADC-2 (adeno-associated virus encoding human aromatic L-amino acid decarboxylase) by~     stereotaxic surgery in patients with advanced Parkinson's disease.~   "
87742|NCT02418585|"~     The purpose of this study is to compare the efficacy and safety of switching~     treatment-resistant depression (TRD) subjects from a prior antidepressant treatment (to which~     they have not responded) to either intranasal esketamine plus a new oral antidepressant or~     switching to a new oral antidepressant plus intranasal placebo.~   "
87743|NCT02418572|"~     Previous work indicates that 2 months androgen pre-treatment may equip preantral follicles~     with more FSH receptors and increase the cohort of follicles surviving to the recruitable~     antral stage. In this regard it may result in an increase in the oocyte yield and the~     reproductive outcome in women with poor ovarian response. These findings provide a strong~     rationale for a definitive large RCT. The TTRANSPORT study will include 400 women with poor~     ovarian response randomized to receive pre-treatment with transdermal testosterone gel or~     placebo in order to provide conclusive evidence regarding the superiority or not of~     transdermal testosterone pre-treatment for the management of poor ovarian responders~     fulfilling the Bologna criteria.~   "
87744|NCT02418559|"~     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of~     JNJ-63623872 following oral administration of single ascending dose of JNJ-63623872 in~     healthy Japanese adult participants.~   "
87745|NCT02418546|"~     This is a phase II feasibility, safety, tolerability and preliminary efficacy study of an~     e-Health application versus in-person nutritional counseling to maintain or increase weight~     in patients with neurodegenerative diseases including amyotrophic lateral sclerosis (ALS),~     Parkinson's Disease (PD) and Huntington's disease (HD). Primary Objectives include the~     feasibility, safety, tolerability and efficacy of an e-Health application to maintain or~     increase body weight compared to in-person nutritional counseling. Secondary Objectives are~     to measure the number of calories required to maintain or increase body weight in~     neurodegenerative diseases at all stages of the disease. Tertiary Objectives are to test the~     effects of an e-Health application compared to in-person nutritional counseling on disease~     progression using the ALSFRS-R, UHDRS or UDysRS, on survival, and on quality of life using~     the PROMIS SF v1.1 scale.~   "
87896|NCT02416583|"~     To compare concurrent oxytocin with membrane sweeping versus dinoprostone pessary in labor~     induction for nulliparas at term with an unfavorable cervix~   "
87897|NCT02416570|"~     This study aims to identify if clarithromycin (CLM) has potential as a widely available and~     inexpensive treatment for cachexia (the loss of muscle mass) in people with non-small cell~     lung cancer (NSCLC). Half the participants will receive clarithromycin and half will receive~     a placebo.~   "
87746|NCT02418533|"~     This study is for couples pursuing in vitro fertilization (IVF) with preimplantation genetic~     screening (PGS) of embryos to achieve pregnancy. The objective of this clinical trial is to~     study the effect of mono-menotropins for COS versus recombinant follicle stimulating hormone~     (rFSH) on cleavage-stage and blastocyst embryo quality after IVF. Embryo quality parameters~     include conventional embryo grade, early embryo viability assessment (Eeva) time-lapse~     parameters, and chromosomal aneuploidy rates after PGS.~      This pilot study is expected to significantly contribute to optimization of treatment~     regimens and stimulation protocols to optimize embryo quality.~   "
87747|NCT02418520|"~     To elucidate the relationship of chewing miswak sticks on the H. Pylori infection in the oral~     cavity.The study would be conducted at the College of Dentistry, KSAU-HS, Riyadh, KSA.~      Oral plaque samples would be obtained from those patients who are willing to participate. As~     a part of the initial screening the plaque samples would be collected and sent for screening~     of oral microbiota to the Microbiology and Biochemistry Department of College of Medicine,~     KSAU-HS, NGHA, Riyadh. Here, the basic microbial culturing (rapid urease test) would be~     performed for detecting the presence of oral H.Pylori. Volunteers who are tested positive for~     H. Pylori infection through the rapid urease test would be invited to participate in the~     study.~   "
87748|NCT02418507|"~     The primary objective for this study is to monitor the change in patient assessed symptoms of~     constipation in subjects taking the proprietary probiotic blend compared to those taking the~     placebo. The secondary objective for this study is to additionally monitor changes in stool~     consistency, stool frequency, quality of life and microbial composition of feces from~     baseline to Day 29, in all subjects. Safety considerations monitored any changes in blood~     safety parameters as well as incidence of adverse events throughout the entire study for all~     subjects.~   "
87749|NCT02418494|"~     This research trial studies health-related symptom questionnaires in measuring quality of~     life in human immunodeficiency virus (HIV)-infected participants treated with or monitored~     for anal lesions. Collecting information and symptoms from patients diagnosed with anal~     lesions may help reduce the risk of anal cancer.~   "
87750|NCT02418481|"~     In this study, effects of γδT cells on human breast cancer (her2-, er-,pr-) in combination~     with tumor reducing surgery, for example cryosurgery going to be investigated.~   "
87751|NCT02418468|"~     This study compared the efficacy of indacaterol versus placebo in COPD patients classified as~     GOLD 2014 Patient Group B.~      This was a 2-arm parallel group study that recruited COPD patients classified by GOLD Patient~     Gorup B. On successful completion of run-in period, patients were randomized in the ratio 1:1~     to receive prn salbutamol plus:~        1. Indacaterol 150ug or~        2. Placebo for indacaterol all once daily (od) for 26 weeks. The primary objective (trough~          FEV1) was assessed after 12 weeks.~   "
87752|NCT02418455|"~     UX003-CL203 is an open-label, multi-center, Phase 2 study to assess the safety and efficacy~     of UX003 in pediatric MPS 7 subjects.~   "
87753|NCT02418442|"~     Continuation of the CARRA Registry as described in the protocol will support data collection~     on patients with pediatric-onset rheumatic diseases. The CARRA Registry will form the basis~     for future CARRA studies. In particular, this observational registry will be used to answer~     pressing questions about therapeutics used to treat pediatric rheumatic diseases, including~     safety questions.~   "
87754|NCT02418429|"~     Recent evidence shows that dietary supplementation with resistant starch (RS) increases fat~     catabolism and resting energy expenditure and decreases plasma insulin and glucose responses~     as well as the gut-derived hormone, glucose-dependent insulinotropic polypeptide (GIP).~     Consumption of whey protein has also been shown to increase energy expenditure and favorably~     affect gut hormones. Thus, investigators tested consumption of both RS and whey protein on~     energy expenditure and gut hormones in lean and obese women and men.~   "
87755|NCT02418416|"~     Novel approach for Oocyte fertilization failure for difficult cases not respond to~     traditional methods of assisted reproduction as intracytoplasmic sperm injection.~   "
87756|NCT02418403|"~     This is a study of the effect of consumer-directed financial incentives on completion of~     advance care planning among Medi-Cal patients.~   "
87757|NCT02418390|"~     The aim of this study is to investigate the efficacy and safety of prophylactic central lymph~     node dissection in papillary thyroid carcinoma.~   "
87758|NCT02418377|"~     Obesity is a complex multifactorial disease where genetics play an important role in~     predisposing children to early onset obesity. Though many obesity susceptible genes and~     variants have been identified with obesity, the most common obesity gene, MC4R only accounts~     for 5% of all early onset obesity cases. This implies that there may be more obesity related~     genes and variants that need to be unravelled to further delineate the relationship between~     obesity and genetics. The investigators propose in screening the exonic regions of all the~     genes in obese subjects using whole-exome sequencing (WES) to discover novel obesity related~     variants and genes.~      Primary hypothesis The investigators hypothesized that our paediatric subjects with~     early-onset severe obesity will have strong genetic predisposition and therefore the cohort~     would be enriched with obesity susceptibility genetic variants.~      Secondary hypothesis The investigators hypothesized that there is increasing prevalence of,~     and possibly worsening, obesity-related complications (namely glucose intolerance,~     hypertension, metabolic syndrome, non-alcoholic fatty liver disease) in our severely obese~     children, as compared to 15 years ago, due to an increasingly obesogenic environment~     promoting unhealthy lifestyle and eating habits.~   "
87772|NCT02418195|"~     The purpose of this study is to examine whether neural-derived exosomal miRNAs are~     differentially expressed that are specific to suicidal ideation or behavior, and which by~     affecting specific miRNA targets and pathways, are associated with suicidal behavior and~     response to ketamine. The following groups of subjects will be examined: 1) major depressive~     disorder (MDD) with a recent suicide attempt (in past 2 weeks), 2) MDD with serious ideation~     (in the past 7 days) without recent suicide attempt (in the past 6 months), 3) MDD without~     clinically significant suicidal ideation (in the past 7 days) or recent suicide attempt (in~     the past 6 months), and 4) healthy controls. Both suicidal and non-suicidal MDD will be given~     ketamine (0.5 mg/kg, IV) and blood will be drawn at predose, 30 min, 180 min, 24 hours, and~     14 days post-infusion to measure changes in miRNAs.~   "
87759|NCT02418364|"~     Infertility is expressed as an inability to conceive or carry a healthy pregnancy to the end.~     It is often said that the couple suffers from infertility if for a year they could not get a~     normal pregnancy. 30% of the reasons for this unsuccess are attributed to women, 30% are~     attributed to men, while the other 40% of cases are attributed to the combination between men~     and women and for unknown reasons. In women, the source of most of the problems of~     infertility are associated with different failures in ovulation (early ovulation, lack of~     ovulation or irregular ovulation). Other reasons are Blocked fallopian tubes (due to~     endometriosis, infection or surgery), problems in the uterus and endometrium. There is a~     group of women that apparently does not have the failures described above, and they have~     infertility that does not include pathological findings. Apparently chronic stress is a~     potential cause among couples who could not get pregnant (despite 6 months of focused sex) so~     there is a request for various techniques for reducing stress including yoga and meditation.~     One common option in various conditions of infertility is in vitro fertilization. This~     technique is also known as artificial insemination and is the most common technique used in~     Israel. Data from the Ministry of Health from the last years, indicate that the rate of~     successful pregnancies after embryo transfer is more than a third (in average), this is from~     an average of 20 treatment cycles.~      Researches in alternative medicine are not easy to carry out. The placebo group which is~     usually the control group tend to be a treatment group by itself and gives effective results~     than a group that does not receive treatment at all. Carrying out a strict study with a good~     control group such as reflexology research in multiple sclerosis, has brought significant~     results in various statistical measures examined in this study (movement, sensory mode and~     urinary tract symptoms).~      In the control group the calf was chosen as a place of a massage as a dummy treatment~     (gynecological place), which prevented contact with specific points of the feet like in~     patients in the treatment group. This study wishes to answer the research question: Does~     reflexology treatment increase the chances of pregnancy implantation in women without~     pathological findings that are treated with IVF. Other questions related to measures that~     could lead to the implant of pregnancy, are whether reflexology treatment affect the~     endometrial thickness, number of oocytes and embryo quality. Literature indicates the~     potential of reflexology treatment on ovulation induction (But requires a good control group~     and large sample size).~   "
87760|NCT02418351|"~     STUDY OBJECTIVES:~      Primary Objective: Assessment of treatment safety based on incidence of any treatment~     emergent/treatment associated adverse events prior to discharge and at 1, 3, 6 and 12 months~     post treatment.~      Secondary objective: Assessment of efficacy at baseline, prior to discharge, 1 month, 3~     months, 6 months and 12 months after treatment based on the following: EDSS and 29-item~     Multiple Sclerosis Impact Scale (MSIS-29), MS Functional Composite (MSFC) consisting of (1)~     Timed 25-Foot Walk, (2) 9 Hole Peg Test, and (3) Paced Auditory Serial Addition Test and~     gadolinium-enhanced magnetic resonance imaging (MRI).~   "
87761|NCT02418338|"~     Compare systolic function of left ventricle (LV) and right ventricle (VD) by 2D strain~     evaluation in Duchenne muscular dystrophy children versus a control group.~   "
87762|NCT02418325|"~     STUDY OBJECTIVES:~      Primary Objective: Assessment of treatment safety based on incidence of any treatment~     emergent/treatment associated adverse events prior to discharge and at 1, 3, 6 and 12 months~     post treatment.~      Secondary objective: Assessment of efficacy at baseline, prior to discharge, 1 month, 3~     months, 6 months and 12 months after treatment based on the following: EDSS and 29-item~     Multiple Sclerosis Impact Scale (MSIS-29), MS Functional Composite (MSFC) consisting of (1)~     Timed 25-Foot Walk, (2) 9 Hole Peg Test, and (3) Paced Auditory Serial Addition Test and~     gadolinium-enhanced magnetic resonance imaging (MRI)~   "
87763|NCT02418312|"~     Whether H2 receptor antagonist can prevent thienopyridine-related peptic ulcer remains~     unclear.~   "
87764|NCT02418299|"~     The purpose of this study was to evaluate the effect of a non-invasive Er:YAG thermal laser~     therapy in treating female stress and mixed urinary incontinence.~   "
87765|NCT02418286|"~     The Purpose of this trial is to define the characteristics of the in/outpatients with low~     back pain in traditional Korean medicine rehabilitation clinic. This information will create~     a registry that will help us to compare similarities and differences in patients and their~     symptoms. The more patients the investigators are able to enter into the registry, the more~     the investigators will be able to understand the low back pain and learn better ways of~     caring for patients.~   "
87766|NCT02418273|"~     The purpose of this study is to evaluate denosumab as a novel treatment for bone loss in~     children treated with glucocorticoids for rheumatic disorders. This is a pilot Phase 1/2,~     randomized open-label, 12-month clinical trial of denosumab to assess its effect on bone~     resorption markers and bone mineral density (BMD) in children with rheumatic disorders, age 4~     to 16 years, recruited within 1 month of starting a chronic systemic glucocorticoid regimen.~     Primary outcomes include suppression of bone turnover markers and safety assessments.~     Secondary outcomes include changes in bone density as measured by dual energy X-ray~     absorptiometry (DXA) and peripheral quantitative computed tomography (pQCT) densitometry at~     the radius and tibia.~   "
87767|NCT02418260|"~     This study intends to determine the best surgical treatment for humeral shaft fractures. One~     third of the patients will be treated with open reduction and internal fixation with plate;~     one third, with bridge plate technique and the remaining third with locked intramedullary~     nail.~   "
87768|NCT02418247|"~     The researchers investigated the rate of biochemical remission in patients without~     radioactive iodine therapy compared to patients with low dose radioactive iodine treatment in~     differentiated thyroid cancer patients who underwent total thyroidectomy.~   "
87769|NCT02418234|"~     The purpose of this study is to compare the frequency and abundance of T790M mutation among~     the different Clinical modes of EGFR-TKI failure.~   "
87770|NCT02418221|"~     This study aims to define a provocation test for histamine intolerance (aka. biogenic amine~     intolerance syndrome) and test the capability of an oral enzyme supplementation to ameliorate~     this condition.~   "
87771|NCT02418208|"~     Purpose: EEstablish normative data of ElMindA's Brain Network Activation (BNA) using evoked~     response potentials in adolescents, young adults and Adults.~      Trial design: Open, one-arm, prospective, age-stratified, multi site. Enrollment size: Up to~     1500 subjects will be enrolled in 4 or more sites. Study duration: Each patient will be~     followed up for up to 1 year. Overall study duration will be up to 1.5 years. Patient~     population: Adolescents, young adults and Adults of both genders.~      Age range:~        -  10-11.99~        -  12-13.99~        -  14-15.99~        -  16-17.99~        -  18-24.99~        -  25-29.99~        -  30-34.99~        -  35-39.99~        -  40-44.99~        -  45-49.99~        -  50-54.99~        -  55-60~        -  60 and above~      Objective: Establishment of normative data of BNA.~   "
87786|NCT02418013|"~     This study aims to carry out a safety evaluation of human cord blood and frozen plasma as~     treatment for pre-frailty , to assess whether the treatment can prevent and improve the aging~     process, and to identify useful clinical markers of frailty.~      The study is a randomized, double-blinded and placebo-controlled pilot clinical Trial~     conducted at CHA clinical trial institute.~   "
87773|NCT02418182|"~     Current standard of care is no pretreatment medications before the egg retrieval, and the~     investigators would like to evaluate if preoperative Tylenol improves procedure and post~     procedure pain control over the current practice (no pre-treatment). Specifically, this study~     will compare Tylenol with a placebo when given before retrieval procedures. The investigators~     believe that if Tylenol can offer better analgesic relief than no pretreatment medications,~     then it may reduce the amount of narcotics needed by patients during and after the procedure~     and contribute to better patient satisfaction. . This study will enroll 100 participants all~     from UAB.~   "
87774|NCT02418169|"~     This study evaluates the association between traumatic brain injuries and craniofacial or/and~     skull fractures. Purpose is to find out the amount of missed diagnoses and improve primary~     diagnostics of trauma patients.~   "
87775|NCT02418156|"~     Objective is to actively gather information on the use of CorMatrix ECM for vascular repair~     in the reconstruction of the femoral artery.~   "
87776|NCT02418143|"~     Actively gather additional information on the use of CorMatrix CanGaroo ECM Envelope in a~     post market observational study.~   "
87777|NCT02418130|"~     A multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy~     and safety of 'Ursa Complex Soft Cap. (UDCA-004)' in patients with physical fatigue.~   "
87778|NCT02418117|"~     The investigators' aim is to evaluate the accuracy of the stereolitographic template~     comparing the final implant insertion to the planned implant position at coronal and apical~     level.~      Clinical relevance:~        -  To identify factors influencing the surgical template imprecision.~        -  To overcome risk factors for surgical template imprecision.~        -  To suggest improvements for highly accuracy of the surgical template especially for~          immediate loading and avoiding the injury of anatomical structures.~   "
87779|NCT02418104|"~     This is a randomized, double-blind, 2-period parallel study in healthy subjects to assess~     immunogenicity and safety of two sequential 6 mg subcutaneous (SC) injections of CHS-1701~     compared with two sequential 6 mg SC injections of Neulasta®.~   "
87780|NCT02418091|"~     This study will build a population management system Simultaneous risk factor control using~     Telehealth to slOw Progression of Diabetic Kidney Disease STOP-DKD Application STOP-DKD APP~     and conduct a 6-month controlled trial to compare reduction of blood pressure. In addition,~     the study will evaluate the feasibility of future large-scale intervention to slow diabetic~     kidney disease (DKD) DKD progression.~      Aim 1: Identify patients with moderate DKD and uncontrolled hypertension (HTN) using existing~     electronic health record data in an integrated data warehouse (Southeastern Diabetes~     Initiative- SEDI) to screen all patients within SEDI.~      Aim 2: Implement an intervention designed to slow progression of DKD and treat associated~     conditions in a high-risk population with moderate DKD and uncontrolled HTN using the~     STOP-DKD APP~        -  Primary Outcome: Test the hypothesis that patients who receive the intervention will~          have greater improvements in blood pressure as compared to a control group after 6~          months~        -  Secondary Outcomes: Exploratory analyses to determine whether patients who receive the~          intervention will have less progression (defined as a smaller decrease in kidney~          function), and improved behaviors that affect HTN control and cardiovascular risk~          (medication adherence, diet, physical activity, and weight control) as compared to a~          control group after 6 months~      Aim 3: Evaluate the STOP-DKD APP Study to guide large-scale implementation & dissemination~        -  Impact Evaluation: Assess the potential population impact of our intervention using the~          Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework~        -  Economic Evaluation: Conduct an economic evaluation using the Archimedes Model by~          estimating projected costs and quality-adjusted life-years~   "
87781|NCT02418078|"~     The aim of this study is to compare the geriatric patients with the non-geriatrics undergoing~     outpatient unilateral herniorrhapy in terms of local anesthesia, sedation, recovery and early~     morbidity.~   "
87782|NCT02418065|"~     The aim of the study is to evaluate a 3 months integrated multimodal therapeutic approach~     including exercise training program with ergocycle during dialysis sessions, oral nutritional~     supplementation, omega 3 and androgen, on effort tolerance and quality of life of~     under-nourish maintenance hemodialysis Chronic Kidney Disease (CKD) patient.~   "
87783|NCT02418052|"~     Esophageal cancer (EC) is the eighth most common cancer and the sixth leading cause of cancer~     deaths worldwide. Minimally invasive esophagectomy (MIE) is regarded as a safe and effective~     management for resectable EC. Gastric tube is considered to be an ideal substitute for the~     resected esophagus, and used for cervical esophagogastric anastomoses for digestive tract~     reconstruction in MIE. However, the tension at the anastomosed area can not be ignored and~     may cause cervical anastomotic leakage (CAL) in some cases. Continuous neck flexion is a~     standard post-operative posture after tracheal resection and reconstruction, and aimed to~     relieve the anastomotic tension. In this study, the investigators attempt to adopt the~     maneuver in MIE, and observe its effect on relieving the anastomotic tension and decreasing~     the incidence of CAL.~   "
87784|NCT02418039|"~     A total of 80 patients diagnosed with liver cirrhosis and minimal hepatic encephalopathy will~     be recruited. They will be randomized to receive high protein diet ( n = 40) and a normal~     protein diet ( n = 40 ) during one month. Randomization will be conducted by an external~     monitor and will keep the secret codes until the end of the study. All patients will be~     provided with structured menus and two snacks a day as an amaranth protein supplement. The~     supplement will content the same amount of fiber but the protein content will vary depending~     on the group to which the patient is assigned.~   "
87785|NCT02418026|"~     Cesarean section rates continue to increase worldwide, particularly in middle- and~     high-income countries. In France, the rate has now stabilized around 20 %. Cesarean section~     is a particular way of giving birth, sometimes desired, but sometimes feared. If some women~     do not feel affected by this way of giving birth, it is more difficult for others to live~     with. In this way, not being able to give birth trough natural way may be disturbing in~     motherhood. At La Rochelle hospital, more than 230 healthcare providers have been trained~     according to Erickson's hypnosis methodology. Among them, 40 are part of the anesthesia~     department and a committee oversees the hypnotherapist activities in pain management. The~     objective of the present study is to assess the benefit of hypnosis session for improving~     experience and reducing anxiety in women giving birth through surgery.~   "
87787|NCT02418000|"~     This is a Phase 1/2a dose-escalation study of E6201, a dual MEK1 and FLT3 inhibitor, in~     subjects with advanced hematologic malignancies with documented FLT3 mutation. The Phase1~     portion of the study will be a safety run-in (up to 30 subjects) to establish a recommended~     Phase 2 dose (RP2D). The Ph. 2a portion of the study will evaluate two specific patients~     groups: Cohort 1 will enroll up to 26 patients with relapsed or refractory AML and confirmed~     FLT3 mutation (with or without a Ras mutation) without prior exposure to a FLT3 inhibitor~     while Cohort 2 will enroll up to 26 patients with relapsed or refractory AML and confirmed~     FLT3 mutation (with or without a Ras mutation) with prior exposure to a FLT3 inhibitor.~     Cohort 3 will enroll up to 10 patients with relapsed or refractory AML with a confirmed Ras~     mutation and no FLT3 mutation. Cohorts 1 and 2 of the expansion phase will incorporate a~     Simon 2-stage optimal design. A total of up to N=92 subjects will be enrolled in the study.~   "
87788|NCT02417987|"~     The aim of the study is to examine patients with chronic Achilles Tendinopathy (AT) and to~     compare the effect of high volume injection (HVI) or autologous conditioned plasma (ACP) in~     combination with eccentric training to placebo treatment (sham treatment combined with~     eccentric exercises).~      Healthy males with AT will be randomly assigned to either 1) HVI (50 mls;10 mls 0.5%~     bupivacaine hydrochloride and 20 mg of Depomedrol followed by 40 mls saline), 2) ACP (~ 4~     mls) or 3) Placebo (Plc) treatment. All subjects will perform a 12-wk eccentric training~     program and examinations will be done at baseline (before treatment) with follow-ups after 6~     weeks, 12 weeks and again after 24 weeks prior to baseline to see any possible changes and~     differences between groups (HVI, ACP and Plc)~   "
87789|NCT02417974|"~     The objective of this trial is to assess if Fecal Microbiota Therapy (FMT) can reduce the~     risk of endoscopic recurrence of CD in patients after intestinal resection. The specific~     outcomes of FMT to be examined are: 1) endoscopic appearance, 2) clinical symptoms, 3) safety~     and tolerability, and 4) microbial diversity. The research team hypothesizes that FMT will~     prevent establishment of pro-inflammatory microbiome after surgery, leading to a reduced~     probability of recurrence of macroscopic inflammation. It is also hypothesized that FMT will~     be safe and well-tolerated in these patients.~   "
87790|NCT02417961|"~     The purpose of the study is to assess functionality, performance, and reliability of an~     accessorized pre-filled syringe (APFS) with benralizumab administered subcutaneously (SC) in~     an at-home setting reported by the patient or caregiver, and to confirm the safety and~     clinical benefit of benralizumab administration in asthma patients with severe asthma.~   "
87791|NCT02417948|"~     This randomized clinical trial uses an educational brochure and online tutorial program to~     assess sun-protective behavior and skin self-examination among African Americans. Skin cancer~     is very common among African Americans, with a disproportionately high mortality rate.~     Providing a brochure and an online educational program about sun-protective behaviors may~     encourage African Americans to take preventative measures against skin cancer, help improve~     early skin cancer detection, determine how far the disease has spread, and plan the best~     treatment.~   "
87792|NCT02417935|"~     The main purpose of this study is to evaluate the effectiveness and safety of the study drug~     known as duloxetine in participants with diabetic peripheral neuropathic pain.~   "
87793|NCT02417922|"~     The purpose is to see if Autologous Conditioned Plasma (ACP) promote and accelerating tendon~     tissue healing in Conservative treated total Achilles Tendon Tears.~      40 healthy males were randomized to either receive ACP or Placebo (saline) around the~     ruptured achilles tendon at baseline, 2 weeks, 4 weeks and again after 6 weeks during the 8~     weeks immobilization period with an orthosis. Ultrasound and symptoms scores (ATLS) was~     performed at baseline, after 8 weeks immobilization and again after 3 month, 6 month and 12~     month. Scoring and functional tests was performed after the 8 weeks immobilization and again~     after 12 weeks, 24 weeks and 52 weeks from injury date.~   "
87794|NCT02417909|"~     Obesity is a major public heath issue. It may have various impacts on a patient's life by~     causing psychological problems, altering a patient's quality of life,etc. These led to the~     investigators' hypothesis which is examining the psychological dimensions of a teenager~     suffering for obesity.~   "
87795|NCT02417896|"~     Our aim is to test whether short term perioperative administration of oral spironolactone~     could reduce incidence of postoperative acute kidney injury (AKI) in cardiac surgical~     patients.~   "
87796|NCT02417883|"~     In kidney diseases, tubule-interstitium has become much more relevant, as formerly only the~     glomerulus was considered to have the main importance. Kidney's tubular atrophy and~     interstitital fibrosis is now recognized as long term prognostic value. We aim to evaluate~     the function of the kidney's tubule-interstitium through furosemide excretion after~     intravenous administration of this drug, and correlate the rate of excretion of furosemide~     with interstitial fibrosis findings in scheduled kidney biopsy for patients with chronic~     kidney disease.~   "
87797|NCT02417870|"~     To investigate the safety and tolerability of treatment with low dose rIL-2 in renal~     transplant recipients. To assess the immunologic impact of low dose rIL-2 in renal transplant~     recipients. To assess the efficacy of low dose rIL-2 in renal transplant recipients.~   "
87798|NCT02417857|"~     The aim of this study is to compare outcomes of quality-of-life measures and evaluate the~     body image and cosmesis between Single Incision Laparoscopic Cholecystectomy (SILC) and~     Conventional Laparoscopic Cholecystectomy (CLC).Twenty eight patients underwent SILC and 30~     underwent LC.Fifty-eight patients were included the study and divided into two groups. The~     results of the questionnaires were statistically compared.~   "
87799|NCT02417844|"~     Two tamsulosin HClformulations will be tested in fed state~   "
87800|NCT02417831|"~     A bio-equivalence of 2 different capsule formulations in fasted subjects~   "
87801|NCT02417818|"~     In plastic and reconstructive surgery, treatment strategies of second-degree burns,~     superficial wounds, burn scars, flaps and chronic wounds aim at reducing infection and~     improving microcirculation. Although previous studies indicate that Plasma Therapy can~     accelerate wound healing, only a few studies focused on the elucidation of its mechanisms of~     action. Therefore, the aim of this study is to evaluate the microcirculatory effects of~     Plasma Therapy on second-degree burns, superficial wounds, burn scars, flaps and chronic~     wounds in a human in-vivo setting for the first time.~   "
87802|NCT02417805|"~     In plastic and reconstructive surgery, treatment strategies of second-degree burns,~     superficial wounds and chronic wounds aim at reducing infection and improving~     microcirculation. Although previous studies indicate that remote ischemic preconditioning~     (RIPC) can accelerate wound healing, only a few studies focused on the elucidation of its~     mechanisms of action. Therefore, the aim of this study is to evaluate the microcirculatory~     effects of remote ischemic preconditioning on second-degree burns, superficial and chronic~     wounds in a human in-vivo setting for the first time.~   "
87803|NCT02417792|"~     At least 20 psoriasis patients will be compared to at least 20 participants without psoriasis~     Bacterial genomic DNA will be extracted from stool samples of participants. The intestinal~     bacterial populations will be compared in order to examine whether there are differences~     between the groups.~   "
87804|NCT02417779|"~     In plastic and reconstructive surgery, treatment strategies of second-degree burns,~     superficial wounds, hypertrophic burn scars, flaps and chronic wounds aim at reducing~     infection and improving microcirculation. Although previous studies indicate that~     extracorporeal shock wave therapy (ESWT) can accelerate wound healing, only a few studies~     focused on the elucidation of its mechanisms of action. Therefore, the aim of this study is~     to evaluate the microcirculatory effects of extracorporeal shock wave therapy on~     second-degree burns, superficial wounds, hypertrophic burn scars, flaps and chronic wounds in~     a human in-vivo setting for the first time.~   "
87805|NCT02417766|"~     Background:~      - There are many types of immune disorders. These range from rare immune deficiencies to~     allergies to autoimmune disease like rheumatoid arthritis. Genes are the instructions our~     body uses to work and develop. A new technology called whole exome sequencing may help find~     the cause of these disorders. Whole exome sequencing is a way to look at many genes at once~     for errors. Researchers hope to find new gene changes that lead to immune disorders.~     Additionally, researchers are interested in finding the best way to manage unexpected but~     important findings by whole exome sequencing.~      Objectives:~      - To better understand genetic causes of immune system disorders. Also, to better understand~     people s thoughts and feelings about immune system disorders and new genomic testing.~      Eligibility:~      - People ages 0 100 with an immune disorder or a relative with an immune disorder. People~     must be at least 2 to be evaluated at the NIH clinical center. People must be at least 12 to~     do the survey/interview portion of the study.~      Design:~        -  Participants will have their genes sequenced. They may be asked for a new sample of~          blood.~        -  If participants cannot come for a study visit, they can have a blood sample collected by~          their local lab or doctor and sent by mail.~        -  Researchers may or may not find the cause of the participant s immune disorder.~          Participants will learn that information. Some participants may be asked to return to~          NIH to get results and have more tests.~        -  Researchers may share information with other studies. The data will be anonymous.~        -  For the survey part of the study, participants will answer questions about their or~          their relative s immune disorder. They will also answer about their thoughts and~          feelings about genomic testing.~        -  Some participants will be asked for a brief interview to ask more about the survey~          topics. There may be more follow-up after several months.~   "
87806|NCT02417753|"~     Background:~      - Some people with gastrointestinal or ovarian cancer also have ascites. That is free fluid~     built up in the abdomen. Researchers want to see if a new drug can affect some of the immune~     cells in the ascites. This may also treat the cancer.~      Objective:~      - To look at the immune markers the ascites of people with gastrointestinal or ovarian~     cancer.~      Eligibility:~      - Adults age 18 and older with a malignancy of the gastrointestinal tract (GI) tract or~     metastatic ovarian cancer. As a result, they have ascites in the abdomen.~      Design:~        -  Participants will be screened with:~        -  Medical history, physical exam, and blood tests.~        -  Echocardiogram: sound waves make images of the heart.~        -  Electrocardiogram: measures electrical activity of the heart.~        -  Paracentesis: a needle will be inserted in the abdomen and will remove some of the~          ascites fluid.~        -  They may have a tumor biopsy.~        -  Participants will get AZD9150 through a vein for 3 hours. They will get this 6 times in~          cycle 1 and 4 times all other cycles. Each cycle is 28 days.~        -  Each cycle, participants will:~        -  Have a physical exam.~        -  Have blood tests weekly.~        -  Be asked about how they feel and any medicines they are taking.~        -  After every 2 cycles (about every 2 months), participants will have scans and x-rays of~          their tumor.~        -  Participants will have paracentesis 2 more times during the study. They will have~          another echocardiogram.~        -  At the end of therapy, participants will have a physical exam and blood tests. They will~          be asked about how they feel and any medicines they are taking.~   "
87807|NCT02417740|"~     Background:~      - Noncirrhotic Portal Hypertension (NCPH) is caused by liver diseases that increase pressure~     in the blood vessels of the liver. It seems to start slowly and not have many warning signs.~     Many people may not even know that they have a liver disease. There are no specific~     treatments for NCPH.~      Objectives:~      - To learn more about how NCPH develops over time.~      Eligibility:~      - People age 12 and older who have NCPH or are at risk for getting it. In the past year, they~     cannot have had other types of liver disease that typically result in cirrhosis, liver~     cancer, or active substance abuse.~      Design:~        -  Participants will have 2 screening visits.~        -  Visit 1: to see if they have or may develop NCPH.~        -  Medical history~        -  Physical exam~        -  Urine and stool studies~        -  Abdominal ultrasound~        -  Fibroscan. Sound waves measure liver stiffness.~      <TAB>- Visit 2:~        -  Blood tests~        -  Abdominal MRI~        -  Echocardiogram~        -  Questionnaire~        -  Liver blood vessel pressure (hepatic venous portal gradient (HVPG)) measurement. This is~          done with a small tube inserted in a neck vein.~        -  They may have a liver biopsy.~        -  All participants will visit the clinic every 6 months for a history, physical exam, and~          blood tests. They will also repeat some of the screening tests yearly.~        -  Participants with NCPH will also have:~        -  Upper endoscopy test. A tube inserted in the mouth goes through the esophagus and~          stomach.~        -  At least every 2 years: Esophagogastroduodenoscopy.~        -  At least every 4 years: testing including HVPG measurements and liver biopsy.~        -  Participants without NCPH will also have:~        -  Liver biopsy and HVPG measurements to see if they have NCPH.~        -  Every 2 years: abdominal MRI and stool studies.~        -  The study will last indefinitely.~   "
87808|NCT02417727|"~     Background:~      - Some people with movement disorders are in another NIH protocol. They will have electrodes~     placed in deep brain areas. They may do tasks before, during, and after surgery. Researchers~     want to learn more about how brain cells and networks work while people learn and remember.~     They want to use the data from the other NIH study to do this.~      Objective:~      - To share data from before and during deep brain stimulation surgery. The data will be used~     in a study of how the brain learns and remembers.~      Eligibility:~      - People at least 18 years old who are in protocol 11-N-0211 and have certain movement~     disorders.~      Design:~        -  As part of protocol 11-N-0211, data on participants brainwave activity is collected. In~          this protocol, they will have that data stored and shared.~        -  Researchers will access imaging data from deep brain stimulation surgery.~        -  Researchers will access other medical records.~   "
87830|NCT02417441|"~     The purpose of the trial is to record the use of the medical device EEVA™ (Early Embryo~     Viability Assessment) by comparing the rate of implantation of transferred embryos selected~     using the scores from the device EEVA™ plus morphology grading versus transferred embryos~     selected using the morphology grading only.~   "
87914|NCT02416349|"~     The purpose of study is to evaluate the acute effects of respiratory muscles stretching on~     ventilator pattern and volume distribution of chest wall in patients with right hemiparesis~     post-stroke and our hypothesis is that the use of RMS will be able to improve changes in the~     respiratory function.~   "
87809|NCT02417714|"~     Background:~      - Computed Tomography (CT) is a scan that makes detailed pictures of the body. It uses~     radiation to do that. In 2011, about 85.3 million CT scans were done in the United States.~     But there is growing concern about the health effects of radiation. There are new and~     different ways to make CT pictures that use less radiation. Researchers want to learn whether~     these new methods create images that are similar to images from a traditional CT.~      Objective:~      - To learn if new CT imaging methods with less radiation make images that are similar to~     traditional ways.~      Eligibility:~      - Adults 18 years of age and older who are scheduled for a CT of the chest, abdomen and~     pelvis with contrast.~      Design:~        -  Researchers will review participants medical records to see if they can be in this~          study.~        -  Participants may have blood drawn from an arm vein by a needle stick. The blood will be~          used to make sure they can be in this study and that it is safe for them to have~          contrast.~        -  During the participants CT scan appointment, one extra scan will be done using low~          radiation methods.~        -  During a CT scan, the participant lies on a table. A large x-ray machine takes pictures~          of the body.~   "
87810|NCT02417701|"~     This phase II trial studies how well sapanisertib works in treating patients with lung cancer~     that is stage IV or has come back (recurrent) and has a mutation in the nuclear factor,~     erythroid 2-like 2 (NFE2L2) or kelch-like ECH-associated protein 1 (KEAP1) gene. Damage to~     these genes may cause the cancer to grow. Sapanisertib may stop this from happening by~     blocking enzymes.~   "
87811|NCT02417688|"~     To demonstrate feasibility of imaging Cu[64]-25%-CANF-Comb uptake in the atherosclerosis of~     the carotid artery of patients for whom carotid artery endarterectomy surgery is planned in~     comparison to the carotid artery for which intervention is not planned.~   "
87812|NCT02417675|"~     The Western Cape province of South Africa (SA) is changing the way it treats pregnant women~     with HIV. Now, all HIV-infected pregnant women, regardless of how sick or healthy they are,~     will receive antiretroviral treatment (ART) for life (Option B+). However, there are few~     well-developed models of service delivery to support this change to Option B+ in the~     Western Cape and many parts of the continent.~      The parent study -- Strategies to Optimize ART Services for Maternal & Child Health~     (MCH-ART)-- is testing two clinic-based models of service delivery for Option B+ . To~     complement MCH-ART, this study, PACER, will test whether community-based Adherence Clubs are~     an effective model for keeping breastfeeding women in HIV care after pregnancy. These clubs~     have been used to free up space at ART clinics by moving stable HIV+ patients to~     community-based services, but they have not been studied as an effective strategy among~     breastfeeding women after delivery. PACER seeks to address this gap.~   "
87813|NCT02417662|"~     The trial will assess the addition of stereotactic ablative radiotherapy (SABR) to standard~     chemotherapy in patients with oligometastatic non-small cell lung cancer. Patients will be~     randomised to receive either standard treatment alone (platinum-based doublet chemotherapy)~     or standard treatment with conventional radiotherapy (RT) and SABR.~   "
87814|NCT02417649|"~     Chronic obstructive pulmonary disease (COPD) are characterized by frequent relapses, often~     resulting from common bacterial infections. Enhancing the immune response in these patients~     may decrease the frequency of these relapses. The use of a mechanic Polyvalent Bacterial~     Lysate (PMBL, Ismigen, 13 bacterial strains)may enhance the immune response and therefore~     help significantly to the control of relapse in these patients.~      In the current study the effect of the administration of the PBML to patients older than 40~     years, with moderate, severe or very severe COPD, in good or discrete physical condition on~     the number of relapses in an observation period of 12 months. In addition, the effect of the~     PMBL on the duration of the interval between relapses, on relapse symptoms, on the use of~     other drugs, on the number of days of absence of work, on the number of hospitalizations and~     duration thereof and on potential toxicity of the treatment.~   "
87815|NCT02417636|"~     PUBLIC HEALTH EVALUATION PROTOCOL on Impact of Task Shifting Type II for ART Delivery on~     Patient and Process Outcomes in Uganda~   "
87816|NCT02417623|"~     AIM: To assess the efficacy of an intervention that includes the assistance of a weight loss~     smartphone application targeted to young people aged 18 to 40 years.~      DESIGN: Randomisedclinical trial.~      SETTING: Primary Health Care centres (PHCCs) in Catalonia.~      PARTICIPANTS: Adults aged 18 to 40 years with criteria of obesity or overweight, consulting~     PHCCs for any reason and who provide written informed consent to participate in the trial.~      INTERVENTION GROUP will receive a 12-month weight loss programme that implements~     recommendations of a Clinical Practice Guideline, complemented with a smartphone app designed~     specifically for this programme.~      CONTROL GROUP will receive the usual care. The outcome measure will be weight loss at 12~     months.~      EXPECTED RESULTS: The investigators expect a higher weight loss in the intervention group~     than in control group.~   "
87817|NCT02417610|"~     The purpose of the study is to assess the validity of the polynucleotide within the intra~     articular treatment of osteoarthritis of the knee, comparing it with that of hyaluronic acid,~     the most commonly used.~   "
87818|NCT02417597|"~     This phase IV clinical study was designed to evaluate the safety and immunogenicity of the~     recombinant Hepatitis E vaccine(Hecolin®), manufactured by Xiamen Innovax Biotech CO., LTD.,~     in healthy volunteers aged over 65 years of age at enrollment. The study volunteers will~     receive the 3 doses of Hecolin® administered intramuscularly according to a 0-1-6 month~     schedule.~   "
87819|NCT02417584|"~     The aim of the study was to determine the long term effects of compliance with positive~     airway pressure therapy on blood pressure in both hypertensive and normotensive patients with~     obstructive sleep apnoea hypopnoea syndrome.~   "
87820|NCT02417571|"~     Control of blood pressure (BP) is the first thing to do in the management of chronic kidney~     disease (CKD). Although guidelines suggest the optimal blood pressure level, it is hard to~     assess BP correctly during the office visit. Often there is a discrepancy between office BP~     and out-of-office BP, including home BP and ambulatory BP. Recent study reported that as many~     as 34% of Korean CKD patients had masked hypertension, which means high BP by ambulatory BP~     monitoring but normal BP by conventional office BP measurement.~      This study aims to evaluate the effect of ambulatory BP-guided BP management on the clinical~     outcome of CKD, compared to the conventional management using office BP.~   "
87821|NCT02417558|"~     The study involves a novel Virtual Reality Interface that offers full-body immersion~     Alterniity AR and more specifically computer exercises blended with game activities. It was~     hypothesized that Alterniity AR facilitated, game blended cognitive and/or physical~     exercise improves global cognition when compared to control groups; moreover, these~     improvements may be manifested by brain activity changes. The investigators explore here the~     impact of potential moderators on combined exercise-induced cognitive benefits, as well as,~     individual/separate training schemes.~      In addition, the proposed study will provide Alterniity AR in a closed feedback loop with a~     direct, reliable, and non-invasive method for assessing changes in brain activity associated~     with elderly in risk of dementia. The paradigm for the current study will combine~     neurophysiological knowledge with mathematical signal processing and pattern recognition~     methods to temporally and spatially map brain function, connectivity and synchronization.~   "
87822|NCT02417545|"~     The aim of this study is to assess the differences in gaze and gait during the stair and ramp~     negotiation (+transition to normal level walking) between healthy controls and vestibular~     patients (fallers and non-fallers).~   "
87823|NCT02417532|"~     Prospective, Open label, single arm, non-randomized, non-comparative registry study of~     Robot-Assisted Physiotherapy Exercises with the REX Robot powered exercise system in patients~     with Spinal cord or other injury preventing unsupported patient ambulation.~   "
87824|NCT02417519|"~     Chlorogenic acid (CGA) in coffee may lower the postprandial glucose response. CGA is~     destroyed by dark roasting. In a controlled crossover trial, 11 healthy fasted volunteers~     consumed 300 mL of either light (LIR) or dark (DAR) roasted coffee, or water, followed 30 min~     later by a 75-g oral glucose tolerance test (OGTT). Plasma glukose and insulin, appetite, and~     plasma and urine metabolic profiles will be analysed. The primary aim is to investigate~     whether roasting affects the postprandial glucose area under the curve (AUC).~   "
87825|NCT02417506|"~     The repetitive motions associated with active life and many sports can increase the wear and~     tear to the joints that leads to decrease in flexibility and joint pain finally heading its~     way to osteoarthritis. Activities such as jumping, running can wear away the cartilage that~     supports and cushions the joints of hands and knees, causing bones to rub against each other.~     Injuries stemming from repetitive motions can also cause and worsen the joint pain.~      Joint pain is discomfort that arises from any joint . Irrespective of the underlying~     mechanisms, joint pain usually originates in activation of nociceptors, or free nerve~     endings. Complex neuronal activation occurs, which involves not only local sensitization of~     joint nociceptors but also modifications in central pain pathways.~      Even though, the numerous pharmacological interventions are available for joint pain, there~     is much debate amongst clinicians about the best approach to the treatment of joint pain.~     NSAIDs which is frequently used for treatment in such cases, carries concerns related to~     gastro-intestinal system, cardiovascular system as well as central nervous system .~      Hence there is a need of a safer alternative treatment option for relieving acute joint pain~     which is comparable to the modern medicines, without posing concerns to the subject's general~     well being.~      Herbs are known to be used since ages in traditional literature and do not pose any potential~     health concern. Inspite of such positive attributes herbs are not employed in treatment of~     acute pains as there is lack of evidence proving the same.~      In order to address the need of the hour Enovate Biolife has invented a novel poly herbal~     formulation E-OA-07 (Lanconone). Lanconone has been studied previously in patients with~     osteoarthritis has been proven efficacious . It has a good history of marketing and is sold~     in the United States, with no reported adverse event related to the product. However there is~     no concrete evidence proving the product's acute pain relieving dynamics, hence the current~     study has been employed to comprehend the effect of lanconone in joint acute pain.~   "
87826|NCT02417493|"~     The purpose of the present study is to determine if asking adolescent patients (ages 13-17)~     to self-inject an empty syringe into their thigh during routine clinic visits results in~     increased reported comfort with self-injection, reduced anxiety regarding self-injection and~     food allergy management for both patient and caregiver(s), and in greater perceived~     likelihood of epinephrine self-injection, in the event of an emergency.~   "
87827|NCT02417480|"~     This study will pilot test the use of two mHealth devices. One is called the Bite Counter and~     one is called a MisFit. The study will be among a sample of participants (n = 50) to monitor~     their eating and sleeping habits. The Bite Counter is a wearable watch-like device that~     detects and records when an individual has taken a bite of food. The benefit of using the~     Bite Counter is that it places a low-burden on participants to self-monitor their dietary~     intake. The MisFit is a commercial device that tracks an individual's sleeping and activity.~      The purpose of this study is to (1) find out how the Bite Counter calculates daily bites~     taken on a vegan diet compared to an omnivorous diet, (2) examine differences in sleep and~     activity between individuals following a vegan diet compared to an omnivorous diet and (3)~     get feedback from users before the device is tested in larger studies.~   "
87828|NCT02417467|"~     Smoking-related diseases contribute to the death of more than 37,000 Canadians annually. Of~     that number, almost one-third die of cardiovascular-related causes. Smoking cessation can~     decrease the additional risk of heart disease by 50% after 1 year. However, even using~     smoking cessation therapies, only 10-20% of smokers will be able to successfully quit smoking~     long-term. Therefore, new and alternative treatments are needed.~      The e-cigarette is a battery-powered device approximately the size and shape of a cigarette~     that creates a smoke-free vapour which is inhaled by the user. Since it feels like smoking a~     cigarette, using the e-cigarette may help some smokers quit. Some e-cigarettes also contain~     nicotine, which can reduce withdrawal symptoms from quitting smoking. However, e-cigarettes~     have not been approved for use for smoking cessation by Health Canada or the FDA. Despite~     this, these devices are rising in popularity. A recent US Centers for Disease Control survey~     found that of smokers who were motivated to quit within the next 6 months, 48.5% had tried~     e-cigarettes.~      The Evaluating the Efficacy of E-Cigarette Use for Smoking Cessation (E3) Trial will be the~     first large trial to address the important issue of e-cigarettes for smoking cessation in~     Canada. The trial will randomly assign participants to receive nicotine e-cigarettes and~     minimal counseling, non-nicotine e-cigarettes and minimal counseling, or only minimal~     counseling for 12 weeks. Participants will then be followed for one year to see which (if~     any) group is more likely to have quit or reduced their smoking. Information about potential~     side effects and safety will also be collected. The E3 Trial will provide law-makers and the~     public with important information about the use of e-cigarettes for smoking cessation.~   "
87829|NCT02417454|"~     The purpose of this study is to investigate the effects of a probiotic blend on qualitative~     (subjective interviews and self-reporting) and quantitative (changes in brain activity, heart~     rate, cortisol, and reactivity) measures of stress in healthy undergraduate students.~   "
87832|NCT02417415|"~     Patients with autonomic failure are characterized by disabling orthostatic hypotension (low~     blood pressure on standing), and at least half of them also have high blood pressure while~     lying down (supine hypertension). Exposure to heat, such as in hot environments, often~     worsens their orthostatic hypotension. The causes of this are not fully understood. The~     purpose of this study is to evaluate whether applying local heat over the abdomen of patients~     with autonomic failure and supine hypertension would decrease their high blood pressure while~     lying down. This will help us better understand the mechanisms underlying this phenomenon,~     and may be of use in the treatment of supine hypertension.~   "
87833|NCT02417402|"~     The aim of this trial is to investigate if patients treated by physical therapists who~     received an update on clinical practice guidelines and pain management have better outcomes~     than patients treated by physical therapists who did not received such training.~   "
87834|NCT02417389|"~     To assess the efficacy and safety of treatment with cinacalcet and with cinacalcet plus~     alendronate in controlling bone loss induced by primary hyperparathyroidism.~   "
87835|NCT02417376|"~     The purpose of this study is to determine whether scaling and root planing as a periodontal~     intervention helps in improving the overall health of patients suffering from coronary heart~     disease.~   "
87836|NCT02417363|"~     Analysis of inflammatory markers in periodontitis and patients with early and middle stage~     renal disease.~   "
87837|NCT02417350|"~     The investigators planned study is a randomized, controlled exploratory study of a ketogenic~     and a NFA (National Food Administration) recommended diet. Study participants will be female~     nutrition students with both knowledge and interest in dietary surveys, in order to increase~     motivation and adherence. They will be provided with cooked food. The women should be weight~     stable and maintain their physical activity during the study, in order to evaluate how the~     diet itself affects various health parameters. The investigators intend to investigate diet~     specific biomarkers (small molecules involved in metabolism) in the blood, as well as blood~     lipids, body composition, gut microbiota, energy substrate utilization, exercise performance,~     resting metabolic rate, hormones, cognition and sweet cravings. In addition, the~     investigators intend to qualitatively study the experience of following both of these dietary~     regimes. The investigators intend to make a short and controlled study. The study is expected~     to reveal whether the ketogenic diet is a healthy or unhealthy diet in the short term. The~     investigators also expect that data from this study will be a helpful tool to measure diet~     adherence in future long-term studies.~   "
87838|NCT02417337|"~     Root canal therapy will ideally eliminate post-endodontic pain but occasionally analgesics~     are needed to diminish the pain [1]. Development of pain after completion of root canal~     treatment may undermine patients' confidence in the procedure and the clinician [2].~     Non-steroidal anti-inflammatory drugs are one of the most frequently taken analgesic~     medications for dental pain. Their popularity attributed to their efficacy in relieving pain~     and fever and low side effect profile at therapeutic doses [3]. Mono-therapy analgesic has a~     low effect on dental pain. Improvement was performance by combining analgesics with different~     mechanisms of action without raising any adverse effects [4], was effective in controlling~     moderate to severe pain. The combination of a non-steroidal anti-inflammatory drug (NSAID)~     and paracetamol has shown additive analgesia for treating dental pain in several studies~     [5,6]. Endodontic treatment with a lower prevalence of postoperative pain is usually the~     treatment of choice. There have been no controlled dental studies evaluating the additive~     effects of combining a non-steroidal anti-inflammatory drug with paracetamol. Breivik et al~     [6] & Menhinick et al [7] found that a combination of acetaminophen and ibuprofen was more~     effective than ibuprofen alone in managing postoperative pain. Aim of the present study, to~     evaluate the efficacy of the paracetamol when used alone and in combinations with three~     groups of drugs to control postoperative endodontic pain.~   "
87839|NCT02417324|"~     The I-HIT-MED registry registers clinical of children and adults with medulloblastoma,~     ependymoma, pineoblastoma, or CNS-primitive neuroectodermal tumour (CNS-PNET) in Germany and~     other countries that fulfil national ethic requirements for participation in this registry.~     These tumours are rare diseases, and many patients are treated outside of clinical trials.~     The I-HIT-MED registry allows collection of data und biological material from those patients,~     and provides a basis for standard treatment recommendations and counselling. It aims to~     improve the international cooperation and the medical knowledge in these rare diseases.~     Within the I-HIT-MED registry, it is a goal to maintain and improve networks for quality~     assurance in national groups where they are already established, and to support the~     implementation in national groups, where there is no quality assurance network yet.~   "
87840|NCT02417311|"~     Heart failure (HF) is the common end-stage of different medical conditions. It is the only~     growing cardiovascular disease and its prognosis remains worse than that of many~     malignancies. The lack of evidence-based treatment for patients with diastolic HF (HFpEF)~     exemplifies that the current one for all therapy has to be advanced by an individualized~     approach. Inherited cardiomyopathies can serve as paradigmatic examples of different HF~     pathogenesis. Both gain- and loss-of-function mutations of the same gene cause disease,~     calling for disease-specific agonism or antagonism of this gene´s function. However,~     mutations alone do not predict the severity of cardiomyopathies nor therapy, because their~     impact on cardiac myocyte function is modified by numerous factors, including the genetic~     context. Today, patient-specific cardiac myocytes can be evaluated by the induced pluripotent~     stem cell (hiPSC) technology. Yet, unfolding the true potential of this technology requires~     robust, quantitative, high content assays. The researchers' recently developed method to~     generate 3D-engineered heart tissue (EHT) from hiPSC provides an automated, high content~     analysis of heart muscle function and the response to stressors in the dish. The aim of this~     project is to make the technology a clinically applicable test. Major steps are (i) in depths~     clinical phenotyping and genotyping of patients with cardiomyopathies or HFpEF, (ii)~     follow-up of the clinical course, (iii) generation of hiPSC lines (40 patients, 40 healthy~     controls), and (iv) quantitative assessment of hiPSC-EHT function under basal conditions and~     in response to pro-arrhythmic or cardio-active drugs and chronic afterload enhancement. The~     product of this study is an SOP-based assay with standard values for hiPSC-EHT~     function/stress responses from healthy volunteers and patients with different heart diseases.~     The project could change clinical practice and be a step towards individualized risk~     prediction and therapy of HF.~   "
87898|NCT02416557|"~     Intraoperative hypothermia is associated with many clinical adverse outcomes. Many techniques~     were applied to prevent intraoperative hypothermia, and positive end-expiratory pressure~     (PEEP) has been known to blunt intraoperative hypothermia by increasing thermoregulatory~     vasoconstriction threshold. The investigators assessed the effect of PEEP on the prevention~     of intraoperative hypothermia during spine surgery in prone position.~   "
87899|NCT02416544|"~     The aim of this study is to evaluate the effectiveness of Low Calorie Low Salt Lunch for~     Weight Reduction in overweight or obese workers of a health promoting hospital.~   "
87841|NCT02417298|"~     Pain associated with sickle cell disease is a common emergency department visit. It is also~     frequently associated with a high emergency department recidivism rate for pain control and~     admissions to the hospital. Opiates are considered the first line therapy for acute flares~     and to manage chronic pain. This often times leads to a stigma of being opiate seekers or~     frequent fliers. With this study, we wish to explore whether adding ketamine to standard~     acute opiate therapy (morphine or dilaudid) will decrease subsequent repeat doses of opiates~     while improving the patient's perception of pain. In addition, we will be exploring whether~     ketamine as an adjuvant therapy can help reduce hospital admissions for the management of~     acute sickle cell crisis pain.~   "
87842|NCT02417285|"~     CC-122-NHL-001 study is a multicenter, open-label, phase Ib study with dose escalation and~     expansion parts. It evaluates the safety, tolerability and clinical pharmacokinetics of~     CC-122 in combination with obinutuzumab (GA101). The study is also assessing the preliminary~     efficacy of the combination as well as pharmacodynamic and tumor biomarkers as exploratory~     objectives. In the dose escalation part, the safety and tolerability of increasing doses of~     CC-122 administered with a fixed dose of obinutuzumab will be administered to identify the~     maximum tolerated dose. In the dose expansion part, more patients will be enrolled at a~     CC-122 dose selected from the escalation part of the study in combination with fixed dose~     obinutuzumab to further study safety and efficacy.~   "
87843|NCT02417272|"~     Background : Cervical degenerative disc disease is frequent and the consequence of aging.~     Degeneration may lead to disc herniation. Surgery is indicated in the presence of root~     compression with cervicobrachial neuralgia and/or myelopathy.~      Purpose: The main objective of the study is the comparison of efficacy between total disc~     replacement (TDR) and Anterior Cervical Decompression and Fusion (ACDF) as surgical treatment~     of symptomatic cervical degenerative disc disease in term of Success rate, defined as~     preservation of adjacent segments, 24 months after surgery.~      In our knowledge, there are no published data about randomized clinical trials comparing~     these radiological parameters (worsening of degeneration signs on static cervical spine~     radiographs and worsening of disc degeneration signs on MRI) at levels adjacent to surgery,~     between these 2 surgical approaches in patients suffering from cervical degenerative disc~     disease.~   "
87844|NCT02417259|"~     We are conducting a prospective cohort study of 20 children with cyanotic congenital heart~     disease who are admitted for cardiac surgery. We will record cerebral and somatic near~     infrared spectroscopy (NIRS) at two sites - forehead and flank regions using the Covidien~     INVOS™ 5100C Cerebral / Somatic Oximeter. The monitoring will begin one hour pre-operatively~     (baseline) and continue until 48hours post-operatively. We will also take measurements prior~     to discharge from hospital. Baseline demographics, physiological and laboratory variables~     will be recorded. Clinical outcome variables including mortality, duration of intensive care~     unit (ICU) stay, duration of mechanical ventilation, inotropic support and feed tolerance~     will also be recorded.~   "
87845|NCT02417246|"~     Recently, the quality of generic metoprolol extended-release (ER) (Toprol XL,~     Activas,Wockhardt) products has been called into question with reports of inconsistent~     effects when switching from the brand name product to a generic formulation. Problems with~     how the body processes these drugs could have serious and widespread consequences given the~     high frequency of metoprolol ER use in the management of various cardiovascular disorders,~     including high blood pressure, coronary heart disease, heart failure, and cardiac~     arrhythmias. Investigators hypothesize that both product- and subject-specific factors lead~     to variability in the way the body breaks down the drug (pharmacokinetics) and clinical~     response to generic versus name brand metoprolol ER formulation. Investigators will study the~     brand name and generic metoprolol ER formulations in subjects with high blood pressure to~     compare the pharmacokinetics and cardiovascular responses among equivalent labeled doses of~     each product.~      The study objective is to provide information on how the body breaks down generic and brand~     name metoprolol ER products (pharmacokinetics) and how the body responds to generic and brand~     name metoprolol ER products (pharmacodynamics) to better understand if generic metoprolol ER~     products are as good as the brand name product.~   "
87846|NCT02417233|"~     This study will evaluate the efficacy of two strategies for enhancing overall preventive~     behaviors, retention in HIV care, and adherence to medication for HIV positive individuals in~     South Africa: SMS text messing and peer navigation services.~   "
87847|NCT02417220|"~     The purpose of this study is to conduct a randomized controlled trial to compare the weight~     losses produced by the Weight Watchers Online program revised for 2015 (WWO2015) and WWO2015~     plus the provision of an electronic scale and weekly email feedback on weight loss (WWO2015~     Enhanced), over a 6-month period.~   "
87848|NCT02417207|"~     The purpose of this study is to observe a new scheme can achieve is the same as the~     traditional scheme of the effect of preventing hepatitis B recurrence.~   "
87849|NCT02417194|"~     The effect of preoperative glycemic control measured by HbA1c on renal cell carcinoma (RCC)~     outcome remains controversial. Thus, the investigators aim to examine the association of~     preoperative glycemic control with oncologic outcomes after radical or partial nephrectomy.~     The investigators will prospectively collect the relevant data including preoperative HbA1c~     in 238 patients of RCC patients undergoing nephrectomy. The associations between clinical~     variables and risk of adverse pathological features and disease recurrence will be tested~     using a multivariate logistic regression and multiple Cox-proportional hazards model,~     respectively.~   "
87850|NCT02417181|"~     The aim of this study is to explore the effect of substituting General Practitioners (GPs) by~     Physician Assistants (PAs) in out-of-hours primary care. Effects are measured in terms of the~     implication for the care model, quality of care delivered by PAs in comparison to GPs; the~     complaints treated by PAs in comparison to GPs; safety, efficiency and patient satisfaction.~     Lastly, this study will provide insight in the changes in costs of healthcare.~   "
87911|NCT02416388|"~     This open label, multicenter phase II/III study with multiple randomization phases at~     differents stages of AML treatment (induction, consolidation and HSCT where applicable) is~     designed to improve OS in younger (18 to 60 year-old) patients, with AML risk-adapted patient~     strategies. Within the intermediate risk AML group, optimal GvHD prophylaxis following~     allogeneic SCT in first CR, after either myeloablative (MAC) or reduced intensity (RIC)~     conditioning, will also be evaluated. With an adaptative design, this clinical trial could~     test up to 3 novel AML agents of interest.~   "
87851|NCT02417168|"~     Fevers raise the concern for serious bacterial infections in pediatric oncology patients~     receiving chemotherapy. The gold standard for diagnosing bacteremia (bacterial infection of~     the blood) is a blood culture. However, bacterial growth may not occur for 48 hours or there~     can be a false negative result.~      Thus, the biomarker, procalcitonin, has been investigated for its predictive ability to~     identify bacteremia earlier than blood culture. We believe that procalcitonin can assist in~     differentiating bacteremia from non-bacteremia infections in febrile pediatric oncology~     patients. A reliable predictor of bacteremia infections in pediatric oncology patients should~     decrease hospitalizations for fever and unnecessary antibiotic treatment.~      In our study we will measure procalcitonin levels in pediatric oncology patients presenting~     with fever. We will measure procalcitonin at the time of admission which is part of our~     standard of care for febrile pediatric oncology admissions. For the purpose of our study, we~     will additionally measure procalcitonin levels at 12 hours and at 24 hours post admission. We~     will examine procalcitonin levels at these three timepoints to determine if elevated~     procalcitonin levels predict bacteremia in pediatric oncology patients with and without~     neutropenia.~   "
87852|NCT02417155|"~     Inflammatory cytokines play a pivotal role in rheumatoid arthritis (RA) and innovative~     non-pharmacological therapies aimed at limiting cytokine production are highly warranted.~     Adrenaline, a neurotransmitter of the autonomic sympathetic nervous system, attenuates~     cytokine production. Along these lines, endogenous modulation of sympathetic activity could~     limit inflammation and therefore represent a treatment modality that would empower RA~     patients to exert self-control over disease activity. However, both the autonomic nervous~     system and the inflammatory response are regarded as systems that cannot be voluntarily~     influenced. Nevertheless, results from two recent studies demonstrate that this is possible~     through techniques developed by 'iceman' Wim Hof, namely meditation, exposure to cold, and~     breathing exercises. Hof himself and healthy volunteers trained by him were able to~     voluntarily activate the sympathetic nervous system, resulting in adrenaline release and~     subsequent suppression of the inflammatory response during experimental human endotoxemia (a~     model of systemic inflammation elicited by administration of lipopolysaccharide [LPS] in~     healthy volunteers). Interestingly, while having been taught all three techniques, during the~     endotoxemia experiment the trained subjects (like Hof himself) predominantly practiced the~     breathing exercises consisting of two different techniques. A `hyper/hypoventilation`~     technique, characterized by cycles of hyperventilation followed by breath retention and a~     `strength ventilation` technique consisting of deep inhalations and exhalations followed by~     breath holding. These techniques resulted in intermittent hypoxia and cyclic shifts in~     acid-base balance. Based on these observations and previous studies, the investigators~     hypothesize that these breathing techniques account for the increased production of~     adrenaline and thus for the suppressed inflammatory response but it is unclear which of these~     two techniques is most important.~   "
87853|NCT02417142|"~     This is a 24-week, randomized, double-blind, placebo-controlled trial of exenatide weekly~     injection (2mg per dose) as an adjunctive therapy in 70 schizophrenia subjects to examine~     exenatide's effects on negative symptoms and cognition.~   "
87854|NCT02417129|"~     This is a Phase III, multicenter, randomized, double-blind, parallel-arm, active comparator~     trial to evaluate BI 695500 versus rituximab as a first-line immunotherapy treatment in~     patients with LTBFL. Patients will be randomly assigned in a 1:1 ratio to receive 375 mg/m2~     of BI 695500 or rituximab via intravenous (IV) infusion once a week for 4 weeks (total of 4~     dosages administered on Days 1, 8, 15, and 22). Disease assessments will be performed at the~     End of Study (EOS) Visit at Week 30.~   "
87855|NCT02417116|"~     Millions of people suffer from dry eye disease, causing symptoms such as redness, burning,~     feeling of sand or grit in the eye and light sensitivity. Dry eye disease occurs when your~     eyes do not produce enough tears or produce poor quality tears. This can happen for a number~     of reasons, including aging, hormonal changes in women and side effects of diseases or~     medications.~      It is now possible to objectively measure the degree of dry eye disease by collecting a tiny~     sample of tears from the corner of the eye and then measuring the amount of salt in the tears~     (termed osmolarity). We aim to establish the overall levels of raised and normal tear~     osmolarity in people presenting to the eye clinic with complaints of dry eye, and relate this~     to other factors such as symptoms, topical and nutritional medication and dry eye treatment.~   "
87856|NCT02417103|"~     The aim of this study is to investigate the effect of the treatment with the GLP-1 Analogon~     Liraglutide on the lipid metabolism an inflammation in adipose tissue.~   "
87857|NCT02417090|"~     Metformin in widely used as the treatment of gestational diabetes. However, it is not known~     whether exposure to metformin in utero has late metabolic effects on the child.~      In this study the investigators investigate metabolism (oral glucose tolerance test, insulin,~     plasma lipoproteins, inflammation markers as well as body composition by DEXA (dual energy~     X-ray absorption) and MRI) in 9 year-old children whose mothers used either metformin of~     insulin during pregnancy.~   "
87858|NCT02417077|"~     This study will examine the perception of facial expressions among individuals with and~     without crow's feet lines.~   "
87859|NCT02417064|"~     The purpose of this study is to compare the efficacy and safety of switching~     treatment-resistant depression (TRD) participants from a prior antidepressant treatment (to~     which they have not responded) to either intranasal esketamine plus a new oral antidepressant~     or switching to a new oral antidepressant plus intranasal placebo.~   "
87860|NCT02417051|"~     The goal of this project is to adapt and test the efficacy of the National Institute of~     Environmental Health and Safety (NIEHS) Disaster Worker Resilience Training (DWRT) Program~     for Superstorm Sandy responders. The DWRT is a brief, 4-5 hour training program designed to~     improve resilience for stress reactions in active emergency responders. A total of 120~     participants will be recruited. 60 will receive the DWRT, and 60 will be assigned to a~     waitlist control condition. A three-month assessment period will be utilized to enable us to~     evaluate the effects of the intervention. Participants assigned to the waitlist condition~     will be offered the option to participant in the course following completion of the 3 month~     wait period. It is hypothesized that, participants attending the DWRT program, as compared to~     those in the waitlist condition, will show increased resilience at three months~     post-intervention as indicated by lower perceived stress, greater posttraumatic growth, more~     positive health behaviors (e.g., sleep, nutrition, exercise), and fewer new PTSD and~     depression symptoms. It is predicted that participants attending the DWRT program, as~     compared to those in the waitlist condition, will demonstrate greater awareness of the mental~     health effects of disasters, including the symptoms of PTSD and depression. It is predicted~     that, participants attending the DWRT program, as compared to those in the waitlist~     condition, will endorse more positive attitudes towards mental health care, including~     willingness to seek treatment if needed.~   "
87861|NCT02417038|"~     Respiratory depression occurs in labor and delivery; noticeably when neuraxial opioids are~     given.Pathophysiological respiratory depression -failure to respond to hypercapnia or hypoxia~     - is challenging to measure clinically.American Society of Anesthesiologist guidelines~     recommend suitable respiratory monitoring for 24 hours post cesarean delivery (CD).~      Use of capnograph will enable us to assess breath-by-breathe respiration in a population~     receiving neuraxial opioids - potentially at risk for respiratory depression.~      Our aim is to assess our ability to capture maternal postpartum respiratory parameters in a~     cohort following opioid neuraxial administration for CD.~   "
87862|NCT02417025|"~     The purpose of this study is to determine whether a scientifically validated treatment for~     Posttraumatic Stress Disorder (PTSD) called Prolonged Exposure (PE) can be delivered~     effectively to Veterans with Military Sexual Trauma (MST) related PTSD using~     videoconferencing technology, which allows a therapist and patient who are not in the same~     room as one another to communicate. The investigators are interested in learning if this form~     of mental health service delivery is an acceptable alternative to traditional face-to-face~     therapy delivered with the therapist in the same room as the patient. This study is being~     conducted at the Charleston VA Medical Center and surrounding Community-Based Outpatient~     Clinics (CBOCs), and will involve approximately 100 female participants.~   "
87863|NCT02417012|"~     This study evaluates the effect of a lifestyle intervention maintenance of glycemic control~     while reducing glucose lowering drugs in patients with type 2 diabetes mellitus. The~     intervention group receives an intensive lifestyle intervention including exercise and diet~     lifestyle modifications. The reference group receives diabetes educational advice. Both~     groups will have their pharmacological treatment regulated across the study. The primary~     hypothesis is that lifestyle change is sufficient to maintain glycemic control while~     decreasing the anti-diabetic medication in a sample patients with type 2 diabetes mellitus.~   "
87864|NCT02416999|"~     This study is to evaluate the effectiveness of ultra-low dose Bevacizumab plus Temozolomide~     for recurrent high-grade gliomas.~   "
87865|NCT02416986|"~     The goal of this study is to evaluate the effects of exposure to standard smoking~     environments on ability to resist smoking as measured with a Delay to Smoking Task. The~     results of this study will inform whether the Delay to Smoking Task is a sensitive measure~     for evaluating environment-provoked craving and smoking behavior.~   "
87866|NCT02416973|"~     To demonstrate the analgesic effectiveness of 2 modalities of PEMF treatment compared to sham~     treatment in patients with persistent pain following lumbar surgery when treatment is~     administered twice daily over a 60 day period.~   "
87867|NCT02416960|"~     Infertility has been currently recognized as a disorder related to obesity. Among several~     metabolic changes associated with obesity, insulin resistance appears to be linked to~     hormonal disorders that affect reproductive system. Leptin and ghrelin are hormones involved~     in energy balance regulation and are also associated with reproductive system regulation, but~     its relationship with infertility is scarce. The aim of this study is to determine the effect~     of a hypocaloric diet with different glycemic indexes on ghrelin and leptin levels, hormonal,~     metabolic and reproductive parameters in infertile overweight or obese women candidates to in~     vitro fertilization. The patients who meet the inclusion criteria and accept to participate~     in the study, will be allocated in one of the following groups: Hypocaloric Low Glycemic~     Index diet group; Hypocaloric Conventional diet group or Control group (maintenance of usual~     diet) and follow the study protocol for 12 week. Immediately after the end of the diet~     protocol, the patients will be submitted to the in vitro fertilization treatment.~   "
87868|NCT02416947|"~     This study is designed to study the dose response effect of continuous Soluble Corn Fiber~     (SCF) intake over a 50 day period on bone resorption in healthy post menopausal women using~     the 41Calcium methodology. To further understand the dose response effect of SCF bone~     biomarkers will be studied.~      Our hypothesis is that soluble corn fiber will reduce bone resorption in a dose dependent~     manner in comparison to placebo when estimated by urinary 41Calcium excretion as well as bone~     biomarkers of resorption.~   "
87869|NCT02416934|"~     This prospective, randomized, double blind, controlled study evaluates the effect of~     perioperative IV steroids versus saline on swallowing after anterior cervical spine surgery.~   "
87870|NCT02416921|"~     The purpose of this research study is to evaluate the effect of a Facebook-delivered~     weight-gain prevention program versus a Facebook-delivered program with general women's~     health information.~   "
87871|NCT02416908|"~     Selinexor has shown single-agent activity in a current phase I study enrolling patients with~     relapsed/refractory AML with durable complete remissions (CR), complete remissions with~     incomplete hematologic recovery (CRi), partial remissions (PR), and stable disease (SD)~     observed. Furthermore, common toxicities included nausea, fatigue, and anorexia and were~     manageable with supportive care agents. Additionally, CLAG chemotherapy has proven activity~     in relapsed and refractory AML, and has been shown to be a relatively well tolerated regimen~     without significant non-hematologic toxicity. Given the established role of CLAG~     chemotherapy, the single agent activity of selinexor, and their non-overlapping toxicities,~     the investigators propose a phase I/II open label study of selinexor in combination with CLAG~     for the treatment of patients with relapsed/refractory AML.~   "
87872|NCT02416895|"~     The purpose of this study is to examine the relationship between Vitamin D status and~     immunity.~   "
87873|NCT02416882|"~     This study tests whether different physical activity patterns are linked an individual's~     genes.~   "
87874|NCT02416869|"~     The aim of this randomized double-blind cross over clinical trial is to investigate~     effectiveness of different routes of applications (intramuscular and submucous at the site of~     surgery) and doses (4 mg and 8 mg) of Dexamethasone on swelling, trismus, pain and quality of~     life after lower third molar surgery.~   "
87875|NCT02416856|"~     The integrity of structural connectivity supporting cortical regions in the left brain~     hemisphere is hypothesized to enable treatment-induced naming recovery in persons with~     language difficulties after a stroke (aphasia). The investigators will map whole brain~     connectivity (i.e., the brain connectome) to investigate the role of cortical connectivity in~     impairment (Aim 1) and recovery (Aim 2) in patients with aphasia undergoing treatment. This~     information will be used to construct personalized markers of anomia treatment outcome (Aim~     3), which may serve as a guide for speech-language pathologists and neurologists when facing~     patient management decisions.~   "
87876|NCT02416843|"~     Overweight and obesity are major problems and their complications such as cardiovascular~     disease and type 2 diabetes mellitus pose great burdens on healthcare systems. There is~     accumulating evidence to support obesity being a chronic inflammatory disorder mediated in~     part by the expansion of adipose (fat) tissue.~      Knowledge of the role of adipose tissue itself has changed dramatically and it has emerged~     that in addition to storing energy as fats; adipose tissue secretes and responds to various~     chemical messengers in the body that are related to metabolism and inflammation. After a meal~     has been consumed, changes in metabolic (and some inflammatory) markers are seen in the~     blood, which may be influenced by metabolic and inflammatory changes occuring in the adipose~     tissue itself.~      The investigators therefore plan to investigate these changes in adipose tissue before and~     after a meal and compare them to changes occurring in the blood. They also plan to~     investigate whether these responses are different in people who are overweight compared to~     'normal' weight.~      Participants will include males aged between 35-55 years who fit the criteria for inclusion.~     After taking some preliminary measurements and monitoring of normal daily activities,~     participants will attend one day of Laboratory testing in the Physiology Laboratories at the~     University of Bath.~      By investigating differences in metabolism and inflammation in adipose tissue and the~     circulation it is hoped that more will be learnt about the development of diseases associated~     with being overweight and ultimately help to develop more effective methods for prevention~     and treatment.~   "
87877|NCT02416830|"~     The purpose of this cohort post market registry is to collect data and create a global~     database on use of embolization devices and embolization procedures outcome. The data~     collected in the cohort will serve a scientific purpose to acquire better insight in~     embolization procedures. This will be achieved by publications in Scientific Journals and by~     presentations at scientific meetings. Additionally it will support the industry on creating a~     better overview of the products used to maintain and enhance the clinical efficacy of the~     used devices. The cohort post market registry represents a novel approach in a way of~     allowing Clinicians to generate reports based on an evolving controlled and well organized~     database~   "
87878|NCT02416817|"~     The purpose of this study is to compare two already validated methods for massive transfusion~     in trauma patients admitted to the emergency room of a large reference hospital.~   "
87879|NCT02416804|"~     Major purpose of this research is to evaluate the effect and usefulness of Buprenorphine~     transdermal system (MTDS) among the patients with lumbar spinal disease who was performed the~     single-level posterior lumbar fusion.~      After surgery, all the patients apply the patient-controlled analgesia. After three days of~     surgery, patients are divided into two groups.Group A is an experimental group that~     administer the BTDS after surgery, and Group B is a control group that take tramadol~     analgesics. If the patient's pain score exceeds the NRS 4, they can take the additional~     rescue medicine, acetaminophen.~      After the surgery, patient's pain score and quality of life would be recorded sequentially.~     The time of recording is postoperative 36 hours, 72 hours, 7 days, 2 weeks, 4 weeks, and 3~     months, respectively.~   "
87880|NCT02416791|"~     Stroke is the second cause of death worldwide and represented the first cause of death in~     Brazil between 2006 and 2010. Most patients survive, and there is a need to develop~     cost-effective rehabilitation strategies to decrease the burden of disability from stroke.~     This study addresses this important issue, by combining two different interventions in the~     early phase post-stroke: robotic therapy associated or not with transcranial direct current~     stimulation (tDCS), as adjuvant interventions to conventional physical therapy, for motor~     upper limb rehabilitation.~   "
87881|NCT02416778|"~     Disordered iron metabolism characterizes an important determinant of impaired exercise~     tolerance and work capacity. Iron-deficiency anemia commonly features impaired aerobic~     capacity caused by decreased oxygen carrying capacity, and has been associated with a~     negative effect on dyspnea and walking distance.~      Apart from that, iron deficiency without anemia was shown to affect endurance and energetic~     efficiency via decreased tissue oxidative capacity. Consequently, depleted iron stores could~     be capable of causing fatigue, breathlessness and impaired exercise tolerance, which are~     common features of chronic cardiopulmonary diseases like chronic heart failure (CHF) and COPD~     (Chronic Obstructive Pulmonary Disease). Indeed, a current surge of interest aimed at~     potential underlying determinants in CHF and COPD independent of the primarily disordered~     organ.~      Recent studies identified iron deficiency without anemia as an independent factor of reduced~     exercise intolerance in CHF as well as in COPD. Moreover, intravenous iron application~     significantly improved exercise capacity in CHF patients with iron deficiency in presence as~     well as in absence of anemia. Comparable to CHF, the daily living of patients with COPD is~     compromised by impaired exercise tolerance.~      However, airflow limitation, as the foremost characteristic of COPD shows only weak~     associations with exercise capacity. In line with that, exercise capacity showed no~     remarkable improvement in lung transplant recipients, underlining the presence of systemic~     determinants of limited exercise tolerance like iron deficiency. The investigators showed~     that iron deficiency is present in 50% of stable COPD patients (unpublished data), which is~     according to recently published data.~      The investigators presume that iron deficiency contributes to limited exercise capacity in~     COPD patients. Thus, the aim of this study is to determine whether iv iron is associated with~     increases exercise capacity in COPD.~      Therefore the investigators hypothesize that filling up depleted iron storages will increase~     exercise capacity, measured by the 6-MWT (Minute Walking Test).~   "
87882|NCT02416765|"~     Postprandial meal glucose control with closed-loop systems (CLS) still needs some~     improvements. In the postprandial period, sensor delay in detecting blood glucose rise after~     a meal together with delays in insulin absorption expose patients to early risk of~     hyperglycemia and then to late-postprandial hypoglycemia. Glucagon infusion in dual-hormone~     CLS has the potential to improve post-meal control as compared to single-hormone CLS allowing~     a better glucose excursion related to a more aggressive insulin infusion while minimizing~     hypoglycemic risk. Several approaches have been tested for the determination of prandial~     boluses during closed-loop operation.~      The objective of this study is to test in outpatient unrestricted settings whether, in the~     context of closed-loop strategy, conventional meal carbohydrate counting could be reduced to~     a simplified qualitative meal size estimation without a significant degradation in overall~     glycemic control in adult patients with type 1 diabetes.~      The investigators hypothesize that in outpatient free-living conditions: 1) Dual-hormone CLS~     with partial boluses is equivalent to dual-hormone CLS with full boluses in terms of mean~     glucose; 2) Single-hormone CLS with partial boluses is equivalent to single-hormone CLS with~     full boluses in terms of mean glucose. Secondary hypothesis are: 3) Dual-hormone CLS with~     partial boluses will decrease time in hypoglycemia compared to single-hormone CLS with~     partial boluses; 4) Dual-hormone CLS with partial boluses is better than sensor-augmented~     pump therapy in terms of mean glucose; 5) Single-hormone CLS with partial boluses is better~     than sensor-augmented pump therapy in terms of mean glucose.~   "
88428|NCT02409667|"~     To demonstrate in the patient pool of PASI 90 responders at Week 24 that secukinumab 300 mg~     s.c. when administered at a longer dosing interval is non-inferior to secukinumab 300 mg s.c.~     every 4 weeks treatment with respect to maintaining a PASI 90 response rate at Week 52.~   "
87883|NCT02416752|"~     Opioid tolerance in the perioperative period is inevitable especially with ultra-short acting~     agents such as remifentanil. Existing evidence had shown that opioid induced hyperalgesia due~     to neuroplastic changes in the central as well as peripheral nervous system leads to~     sensitization of pro-nociceptive pathways. However there has been a controversy of occurrence~     of such tolerance following the use of remifentanil and the quality of recovery as compared~     to conventional opioids. The investigators evaluated the occurrence of opioid tolerance and~     other significant adverse effects with remifentanil in subjects undergoing head and neck~     surgeries. The investigators studied ASA physical status I and II adult subjects undergoing~     elective head and neck procedures, under general anesthesia with minimum expected duration of~     2 hours. The remifentanil infusion was used in one group and intermittent boluses of morphine~     or fentanyl administered in another group. They were evaluated for immediate post-operative~     pain by using numerical rating scale (NRS), the opioid consumption, post-operative nausea,~     vomiting, other significant adverse effects of remifentanil and the time to discharge from~     PACU.~   "
87884|NCT02416739|"~     Nicotinamide is an inhibitor of human sirtuins (HDAC III), and is found to re-activate~     epigenetically silenced tumor suppressors, RUNX3 (runt-related gene 3) and others, in cancer~     cells. Nicotinamide was found to be effective in several animal cancer models including lung,~     bladder, liver, etc. The purpose of this study is to determine whether nicotinamide is also~     effective in the treatment of human lung cancer.~   "
87885|NCT02416726|"~     The objective of the study was to compare the gene mutation status among the primary tumor,~     matched metastatic lymph node (LN) and peripheral blood in advanced nonsquamous non-small~     cell lung cancer (NSCLC) using next-generation sequencing (NGS).~   "
87886|NCT02416713|"~     Research participants will be recruited to take part in a randomized control trial.~     Participants' cellphone use will be observed during an initial baseline period. Participants~     will then be randomly assigned to one of four conditions: education only (control), opt-in~     blocking, opt-out blocking, and opt-out blocking with parental notification.~   "
87887|NCT02416700|"~     The main objective of this prospective, controlled, and randomized clinical study is to~     evaluate the peri-implant bone loss of immediately loaded versus conventionally loaded~     implants with a single prosthesis. A split-mouth experimental design will be used, and the~     success rate of the installed implants will be determined. Twelve selected patients~     (corresponding to a minimum of 24 surgical implant sites) will receive endosseous Ti dental~     implants. The protocol for preparing the surgical sites will be based on the manufacturer's~     recommendations and bone density. Patients with an initial torque less than 30 N·cm and an~     implant stability quotient (ISQ) less than 60 will be excluded from the research. Envelopes,~     indicating which site is the test site, will be opened after the implants are installed.~     Transfer impressions of the implants receiving immediate loading will be produced so that~     temporary crowns can be made. Temporary crowns will be installed a maximum of 24 hours after~     the surgery, by using the torque recommended by the manufacturer. Appropriate occlusal~     adjustment will be made to ensure minimal contact at maximum intercuspation and absence of~     contacts during protrusive and lateral excursive movements of the jaw. At baseline (time of~     implant installation) and 3, 6, 9, and 12 months after implant installation, the following~     aspects will be evaluated: the initial torque at the moment of implant insertion, Osstell~     ISQ, pain in the implant when subjected to vertical and horizontal forces, clinical mobility~     of the implant, crestal bone loss around the implant (as determined by x-ray evaluation),~     probing depth around the implant, and periodontal pain.~   "
87888|NCT02416687|"~     The etonogestrel (ENG) implant inserted immediately postpartum reduces the risk of pregnancy~     recurrence, especially in vulnerable populations. A limitation to recommending this practice~     universally is the low quality of evidence on the effect of the ENG implant on breastfeeding~     when inserted immediately postpartum. This study is the first assessing the impact of~     inserting the ENG implant immediately postpartum on the amount of milk using the gold~     standard method for this purpose.~   "
87889|NCT02416674|"~     Abdominal wall transplantation surgery is the transfer of abdominal wall tissues from a~     deceased human donor to a patient with a large abdominal wall defect. Abdominal wall~     transplantation is an innovative reconstructive procedure that has the potential to~     significantly improve the lives of patients with large abdominal wall defects. The purpose of~     this study is to develop the best practices for abdominal wall transplantation that will~     improve the outcomes of future abdominal wall transplant recipients.~   "
87890|NCT02416661|"~     This study should demonstrate the correlation and predictive value of lyso-Gb1 concentration~     with the clinical severity of naïve, initially non-ERT/SRT Gaucher disease type 1 and during~     the study ERT/SRT-newly started Gaucher type 1 patients~   "
87891|NCT02416648|"~     The purpose of this study was to determine the effectiveness of a clinician client centered~     counseling on knowledge on HIV transmission and prevention, attitudes towards HIV/AIDS, and~     sexual behaviors of adult HIV patients enrolled in care in Yola, Nigeria.~   "
87892|NCT02416635|"~     Circulating tumor cells (CTCs) have the potential to provide a surrogate for'real-time~     biopsy' of tumor biological activity. Enumeration and molecular characterization of CTCs in~     liver cancer could play an important role in diagnosis, predicting the risk for tumor~     recurrence, and providing novel target therapy biomarkers. In view of these facts, the~     investigators wanted to demonstrate the value of multiparameter flow cytometry in detecting~     human tumor cells of liver cancer in normal peripheral blood after cryosurgery with or~     without dendritic cell(DC)-cytokine-induced killers(CIK) treatment, and the investigators~     also compared the specificity with reverse transcriptase polymerase chain reaction (RT-PCR)~     method.~   "
87893|NCT02416622|"~     This study will evaluate the safety and efficacy of a recombinant adeno-associated virus~     vector expressing retinoschisin (rAAV2tYF-CB-hRS1) in patients with X-linked retinoschisis.~     Up to 27 participants will be enrolled and 3 dose levels will be evaluated in a dose~     escalation format.~   "
87894|NCT02416609|"~     Aim of this study is to evaluate if low-dose radiotherapy (LDR) can intensify local effect of~     a chemotherapy regimen with Gemcitabine and Oxaliplatin administered sequentially with~     stereotactic body radiotherapy (SBRT) and to assess the safety and efficacy of this combined~     treatment on patients affected by locally advanced pancreatic adenocarcinoma (LAPC).~   "
87900|NCT02416531|"~     Vulvar lichen sclerosus (VLS) is a lymphocyte-mediated disease of unknown etiology that can~     cause intense itching as well stenosis, hindering the evacuation and urination. It can also~     limit the sex life due to severe local pruritus, pain and dyspareunia (pain during sexual~     intercourse). The standard treatment for this disease is the use of topical corticosteroids~     to reduce the clinical symptoms and to try to increase disease-free intervals. Photodynamic~     therapy (PDT), a treatment that associates a light radiation with a photosensitizing agent~     and low-level laser therapy (LLLT) are therapies that can promote effective immunomodulatory~     responses at the application site by means of photophysical and photochemical phenomena from~     the molecular to the systemic level, which promote their use in chronic dermatoses. The aim~     is to study and compare the effects of PDT, LLLT, and topical corticosteroid in VLS~     evaluating clinical, histological, immunohistochemical and spectroscopic responses. The study~     will be prospective, randomized, and controlled, in a population of 60 women with~     histological diagnoses of VLS, enrolled on the outpatient clinic of Genitoscopy Department of~     the Pérola Byington Hospital in São Paulo. There will be 3 treatments groups: PDT, LLLT and~     topical corticosteroid, where will be allocated by randomization 20 patients in each one. The~     clinical course will be monitored by measuring local temperature, itching, clamping~     (atrophy), and the appearance of the lesion. Histologically, the slides will be classified~     according to the Hewitt grading and will have the ordering of collagen fibers quantified.~     Immunohistochemical analysis will be done using the markers IFN-γ, TGF-β, CD4, CD8, IL-1, p53~     and Ki-67. Finally, the spectroscopic evaluation will be done by reflectance. Descriptive and~     inferential statistical analyses will be conducted to compare the groups and for associations~     between different responses.~   "
87901|NCT02416518|"~     Genetic Exploration of the Molecular Basis of Malignancy in Adults.~   "
87902|NCT02416505|"~     This study is a Non-funded, Single Center, Multi-Arm, Parallel Group Randomize Control Trial.~      In this study, the investigators aim to evaluate the impact of a visual aid on patient~     comprehension an orthopedic informed consent discussion in low socioeconomic populations.~      The primary outcome is patient comprehension measured by a Validated Knowledge-Based Multiple~     Choice Questionnaire.~      The secondary outcomes include: Patient satisfaction and Time efficiency.~      The investigators hypothesize that using an Anatomic Model Visual Aid during an orthopedic~     informed consent discussion will improve patient comprehension, satisfaction and~     time-efficiency of orthopedic care.~   "
87903|NCT02416492|"~     The primary purpose of the clinical study is to evaluate the clinical efficacy of~     intracranial administration of SB623 cells on patients with chronic motor deficit from~     Traumatic Brain Injury. A secondary purpose of the study is 1) to evaluate the effect of~     intracranial administration of SB623 cells on disability parameters and 2) to evaluate the~     safety and tolerability of intracranial administration of SB623 cells. Patients with stable,~     chronic motor deficits secondary to focal traumatic brain injury must be 12 months post TBI.~   "
87904|NCT02416479|"~     With kidney transplant (KT) recipients as our exemplar population, our goal is to develop and~     test interventions that increase medication adherence (MA) in chronically ill adults. Among~     adult KT recipients, non-adherence to immunosuppressive medications (MNA) is the leading~     predictor of poor outcomes, including rejection, kidney loss, and death. An alarming~     one-third of KT patients experience MNA even though the problem is preventable. Adherence~     intervention studies have proven marginally effective for those with acute and chronic~     illnesses and ineffective for adult KT recipients. Using a randomized controlled trial design~     with an attention-control group, this R01 will test an innovative 6-month SystemCHANGE~     intervention to enhance immunosuppressive MA in adult non-adherent KT recipients. This~     intervention shows great promise for increasing MA with a large effect size of 1.4 in our~     pilot study. Grounded in the socio-ecological model, SystemCHANGE seeks to systematically~     improve MA behaviors by identifying and shaping routines, involving supportive others in~     routines, and using medication taking feedback through small patient-lead experiments to~     change and maintain behavior. The Medication Event Monitoring System cap, which contains~     microelectronics that record the date and time of the cap removal, will be used to measure~     MA. Persistence of the MA behavior change will be examined by evaluating the difference in MA~     between the two groups during the 6-month maintenance phase. Mediators and moderators of MA~     will be examined. Health outcomes will be compared and a cost-effectiveness analysis will be~     conducted.~   "
87905|NCT02416466|"~     This is an open label fixed dose phase Ib of anti-CEA CAR-T cells hepatic artery infusions~     and yttrium-90 SIR-Spheres in patients with CEA-expressing liver metastases.~   "
87906|NCT02416453|"~     The purpose of this study is to evaluate the safety and tolerability of 3 vaccination~     schedules of Ad26.ZEBOV and MVA-BN-Filo administered intramuscularly (IM) as heterologous~     prime-boost regimens.~   "
87907|NCT02416440|"~     Type 2 diabetes (T2D) is an emerging epidemic in sub-Saharan Africa, with an estimated~     prevalence of 6%. With around seven million cases of T2D in 2000, it is anticipated that over~     18 million Africans will have the disease by 2030. In South Africa the prevalence of T2D in~     people of African descent has been reported to be between 3-10%. However, there have been~     limited studies on diabetes epidemiology in South Africans using currently employed World~     Health Organization (WHO) criteria.~      To assess the burden of T2D and associated risk factors in South Africa, we are establishing~     the Durban Diabetes Study (DDS) - a population-based cross-sectional study in the city of~     Durban (the eThekwini municipality) to be undertaken in 1,200 participants of African~     descent. In-depth health questionnaire responses, biophysical measurements and blood and~     urine samples will be gathered from these participants. These data will allow researchers to~     estimate the population prevalence of T2D and associated risk factors in the region. The~     infrastructure created for this cross sectional study has the potential to serve as a strong~     framework for future research initiatives and public health interventions within the region.~   "
87908|NCT02416427|"~     This pre-surgical, window-of-opportunity study is designed to investigate whether~     atorvastatin reduces the proliferation marker Ki-67 via modulation of the Hippo transducer~     TAZ.~   "
87909|NCT02416414|"~     To compare the performance of the QuantiFERON Monitor assay against existing methodology.~   "
87910|NCT02416401|"~     Healthy aging is associated with a decline in multiple cognitive domains, as well as motor~     control function. The long-term consequences of cognitive and functional impairment resulting~     from age-related cognitive decline are well documented in the scientific and clinical~     literature, with significant evidence of related problems with independent functional~     abilities. This study aims to understand how the experimental computer program can affect~     cognition and attention in participants with age-related cognitive decline.~   "
87912|NCT02416375|"~     The study aims to establish if it is possible for people with Cystic Fibrosis to monitor a~     number of parameters on a daily basis at home which might predict respiratory infections~     before they have symptoms and which might also predict treatment failures before this is~     obvious with conventional measures.~   "
87915|NCT02416336|"~     The aim of this study is to investigate whether the Sentinella camera improves intraoperative~     detection and removal of sentinel lymph nodes (SLNs) when used in conjunction with standard~     detection methods. Of primary interest is whether the Sentinella camera identifies additional~     tumor-positive SLNs that are missed using traditional imaging techniques. Other outcomes~     related to the standard of care use of the Sentinella camera may also be assessed.~   "
87916|NCT02416323|"~     The purpose of this study is to test the effectiveness of training community mental health~     therapists to deliver a mental health intervention for ASD (AIM HI) and study the process~     of implementing AIM HI in community mental health programs.~   "
87917|NCT02416310|"~     To determine whether treating by transcutaneous electrical acupoint stimulation (TEAS) during~     perioperative could alleviate the postoperative gastrointestinal complications after cesarean~     section under combined spinal epidural anesthesia compared with control and non-acupoint~     group.~   "
87918|NCT02416297|"~     The purpose of this research study is to assess the clinical effectiveness of a minimally~     invasive alveolar microperforation procedure to achieve accelerated tooth movement in~     patients undergoing orthodontic treatment for orthognathic surgery. Accelerated tooth~     movement means that Microperforation technique may help complete orthodontic treatment~     sooner than would be expected in conventional orthodontic treatment~   "
87919|NCT02416284|"~     The Norwegian Directorate of Health recently published the Norwegian food-based dietary~     guidelines (NFBDG) in 2011. The target for the NFBDG is the general population, and the main~     aims of these guidelines are to promote public health and prevent chronic degenerative~     diseases. Reaching the healthy population is crucial as only small proportion of the general~     population comply to the current public dietary advice in Norway. Thus, the objective of this~     study is to investigate whether a multi-faceted dietary intervention could increase~     compliance to the NFBDG and affect biomarkers of chronic degenerative diseases in a healthy~     population.~   "
87920|NCT02416271|"~     The main purpose of this study is to evaluate the effects of teriparatide with those of~     alendronate on spine bone mineral density (BMD) and other osteoporosis factors in~     postmenopausal women with osteoporosis.~   "
87921|NCT02416258|"~     The purpose of this study is to evaluate the anti-psoriatic effect of LP0113 aerosol spray~     compared to Daivobet® gel, LEO 90100 aerosol foam, betamethasone dipropionate in the aerosol~     spray vehicle, calcipotriol in the aerosol spray vehicle and aerosol spray vehicle.~   "
87922|NCT02416245|"~     The aim of the current study is to investigate the beneficial impact of 4 month consumption~     of a beverage powder fortified with Brahmi (Bacopa monnieri) extract and multiple vitamins~     and minerals on short term memory as assessed using standardised cognitive test battery.~   "
87923|NCT02416232|"~     This is a single arm open label, multicenter, non randomized, access study of trametinib for~     subjects with histologically confirmed cutaneous melanoma with a BRAF V600E/K positive~     mutation that is either advanced unresectable (stage IIIc) or distant metastatic (stage IV).~     Trametinib may be given as monotherapy or in combination since first line metastatic melanoma~     as per inclusion criteria. Subjects who received prior BRAF inhibitor may be included if they~     have not progressed under such treatment or if they have presented limited progression as per~     eligibility criteria. It is estimated that between 250 and 400 subjects with histologically~     confirmed cutaneous melanoma with a BRAF V600E/K positive mutation that is either advanced~     unresectable (stage IIIc) or distant metastatic (stage IV) will be enrolled.~   "
87924|NCT02416219|"~     Rapid Sequence Induction (RSI), with cricoid pressure is advocated for all obstetric patients~     undergoing general anesthesia. Applying cricoid pressure correctly is crucial to prevent~     aspiration. Using Ultrasound guidance we will be assessing the ability of different~     disciplines of caregivers to correctly localize the cricoid cartilage in obstetric patients~     by anatomical landmark palpation.~   "
87925|NCT02416206|"~     High-dose chemotherapy and autologous stem cell transplantation (ASCT) as part of the~     up-front treatment of patients with multiple myeloma has been associated with improved~     disease-free and overall survival in multiple large randomized controlled trials. Following~     3-6 cycles of standard induction therapy with biologic agents, consolidation with high dose~     Melphalan and ASCT has become the standard-of-care approach for fit myeloma patients up to 70~     years of age. Single-agent high-dose Melphalan (200mg/m2) is currently the standard-of-care~     preparative regimen prior to autologous transplant in Myeloma. Historical studies utilizing~     Busulfan- or Total Body Irradiation-based preparative regimens have yielded similar results~     to single-agent Melphalan with higher toxicity.~   "
87926|NCT02416193|"~     Diabetes increases the risk of cognitive dysfunction. The incidence of dementia is 1.5 to 2.5~     times higher in persons with diabetes than the general population. There is evidence that~     cognitive decline significantly impacts the ability to self-manage diabetes. Strategies to~     prevent cognitive decline in persons with diabetes has not been well studied. A recent study~     reported that in persons who had vitamin D deficiency, the risk for all-cause dementia and~     Alzheimer's was doubled. Vitamin D receptors are located in the brain and deficiency of~     vitamin D has been reported to negatively affect the development of brain. Therefore,~     providing vitamin D supplementation to improve cognitive function is worthy of study. The~     investigators propose a small, randomized controlled trial to determine the effects of~     vitamin D3 supplementation in persons with type 2 diabetes who have symptoms of cognitive~     impairment. Persons will be randomized to receive either weekly vitamin D3 supplementation~     (50,000 IUs) or a matching comparator (5000 IUs) for a period of three months. The study aims~     are to determine (1) the effect of vitamin D3 supplementation on cognitive function and (2)~     the effect of vitamin D3 supplementation on diabetes self-management. A sample of persons~     with type 2 diabetes (n=62), who have a subjective complaint of a cognitive dysfunction or~     scoring at least one standard deviation below normal on a cognitive functioning screening~     test, have vitamin D levels less 30 ng/ml, are not depressed (as this impacts cognitive~     function), and do not have severe diabetes complication will be recruited. Participants will~     be phone screened and complete two baseline visits prior to randomization. They will then~     have phone call and follow-up visits to assess (1) cognitive function using standardized~     tests to assess for executive function (2) serum measurements (HBA1c, fasting glucose,~     vitamin D levels, and cardiometabolic profile) and (3) surveys to assess cognitive function~     as well as self-management behaviors.~   "
87935|NCT02416076|"~     Up to 40 subjects will be enrolled, randomized and treated. Enrolled subjects will receive~     one, split-face Ulthera® treatment on the face and neck using a standard transducer on one~     side of the face and a simulines transducers on the other side of the face. Follow-up visits~     will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment,~     immediately post-treatment, and at each follow-up visit.~   "
87936|NCT02416063|"~     The aim of this prospective randomized double-blind study was to compare the analgesic~     efficacy and the side effects of dexmedetomidine (1 µg.kg-1) co-administered with bupivacaine~     for caudal analgesia or intravenously in children undergoing infra-umbilical surgery.~   "
87927|NCT02416180|"~     This study aims to explore the potential impact of switching inhalers by assessing the~     handling error rate (critical and non-critical) in controlled asthmatics currently treated~     with, and using correctly, SERETIDE via the DISKUS Inhaler who are switched to receiving~     SERETIDE via the Metered Dose Inhaler (MDI) (EVOHALER) without training by a Healthcare~     Professional (HCP).~      This will be a descriptive, multi-centre, open-label, non randomized 14 day study assessing~     MDI technique in subjects with controlled asthma (Asthma Control Test [ACT] score >= 20 at~     Visit 1) currently treated with, and able to use correctly, SERETIDE via the DISKUS Inhaler.~     All the eligible subjects will be switched to an equivalent dose of SERETIDE via the MDI.~     Subjects will need to use the MDI inhaler in accordance the accompanying patient information~     leaflet (to be read prior to use) for approximately 14 days. No instruction, coaching or~     comment on inhaler technique will be provided by the HCP. MDI technique of subjects will be~     assessed at Visit 2 (after 14 days) and the errors will be recorded. Subject will revert back~     to using their SERETIDE DISKUS inhaler again from Visit 2. Subjects will be followed up by~     telephone for approximately 1 week after Visit 2.~      A maximum of 110 subjects will be enrolled such that approximately 100 evaluable subjects~     complete the study. The total duration of the study for each subject will be approximately 21~     days.~      SERETIDE, EVOHALER and DISKUS are registered trademarks of the GlaxoSmithKline (GSK) group of~     companies~   "
87928|NCT02416167|"~     The purpose of this study is confirmatory investigation of safety and efficacy (dose response~     and optimal dose according to the percent reduction from baseline in serum urate level at the~     final visit) of FYU-981 administered orally to hyperuricemic patients with and without gout~     for 12 weeks (dose-escalating initial period: 4 weeks followed by maintenance period: 8~     weeks) by the method of randomized (dynamic allocation), placebo-controlled, double-blind,~     parallel group comparison.~   "
87929|NCT02416154|"~     The proposed study aims to determine the expression of Interferon-ε (IFNε) in the female~     genital tract, which has never been mapped before in humans. High expression in other~     mammalian female reproductive tract (FRT) has been suggested to be important in anti-sexually~     transmitted infection (STI)/HIV immunity and its expression decreases with progestogen~     treatment. Future studies are planned to understand if hormonal contraceptives affect the~     presence of interferon in the healthy female genital tract, potentially changing the risk of~     for STI and HIV.~   "
87930|NCT02416141|"~     If a termination of pregnancy procedure is performed by vacuum aspiration our patients~     receive a paracervical block. Nevertheless these patients are not free of pain. We randomised~     our patients: one group will receive additional orodispersible tramadol, the other group will~     receive a placebo.~   "
87931|NCT02416128|"~     The investigators plan to use an herbal eye drop, Euphrasia, aka Eyebright, for~     post-operative inflammation for Peripheral Laser Iridotomy for the treatment of narrow angle~     glaucoma. A peripheral Laser Iridotomy is a simple laser procedure with few complications if~     the patient follows the post-operative instructions. In this procedure, a blue-green Argon~     laser is used to create an orifice in the iris to open the angle by allowing the aqueous from~     behind the iris to enter the anterior chamber. Rarely the procedure needs to be repeated. The~     main complications from this surgery are postoperative inflammation, bleeding, and~     postoperative pressure spikes.~      The investigators will be using Weleda's Euphrasia D3 eye drops. The investigators plan to do~     a double blinded randomized control trial to objectively measure ocular inflammation in the~     same process that was used for the steroid eye drops that are currently out on the market.~     Some patients will be receiving steroids, prednisolone acetate, others, the herbal eye drop.~   "
87932|NCT02416115|"~     Postoperative nausea and vomiting (PONV) is one of the most undesirable complications after~     general anesthesia, and may lead to increased hospital stay and health care costs. The risk~     factors for PONV include sex (female population), nonsmoking status, past history of motion~     sickness and/or previous PONV, duration of anesthesia and surgical type (particular~     gynecologic surgery) and postoperative use of opioids. The overall incidence of PONV has been~     reported to be 30% with considerable variability, but can increase up to 69%- 80% in women~     undergoing gynecologic surgery with general anesthesia and morphine-patient controlled~     analgesia (PCA). Serotonin receptor antagonists (5-HT3) have been suggested one of the first~     line therapies for preventing PONV because of their efficacy and few side effects compared~     with other antiemetics. However, despite the use of this treatment, the incidence of PONV has~     been reported to be between 48 % and 50%. Naloxone is a drug used to counter the effects of~     opioid. It was found that administration of low dose naloxone prevents opioid side effects~     such as nausea and pruritus without affecting analgesia or opioid requirements in patient~     receiving morphine PCA. It was reported that the use of two antiemetic acting at different~     mechanisms is better to prevent PONV than monotherapy.~      Therefore, this prospective, randomized, controlled study was designed to investigate the~     antiemetic efficacy of combination of ramosetron and premixture of naloxone with morphine PCA~     after gynecologic surgery.~   "
87933|NCT02416102|"~     This is a proof of concept, open label protocol to evaluate the effect of losartan on~     cigarette smoke-induced lung injury in smokers, ex-smokers with and without chronic~     obstructive pulmonary disease (COPD), giving 50 mg and subsequently 100 mg losartan for 4~     weeks~      Aim: To test that inhibition of T-cell growth factor (TGF-ß) with losartan in ex-smokers with~     COPD and active and passive smokers without COPD will lead to an increase chloride~     conductance through calcium-activated chloride channel (CACC), as measured by nasal potential~     difference (NPD).~      Study design: The Investigators will assess the consequences of active and passive smoking~     and the treatment with losartan on CaCC-mediated chloride conductance in human beings using~     NPD measurements.~      NPD is a direct measure of ion transport. It measures CaCC-mediated Cl- secretion and thus~     serves as an indirect measure of voltage-dependent potassium (BK) channels function. In~     addition, improvement of NPD measured ion transport was indirectly linked to lung function~     improvements and clearance in trials with cystic fibrosis patients. Therefore, NPD lends~     itself as a good surrogate for Mucociliary clearance (MCC), in a proof of concept clinical~     trial.~      The investigators will also measure TGF-ß levels in nasal secretions and cells to correlate~     these with the level of CaCC-mediated Cl- conductance.~   "
87934|NCT02416089|"~     The purpose of the study is to evaluate the safety, feasibility and applicability of a new~     device 'Tampostat' in the management of primary postpartum hemorrhage and compare the~     efficacy of 'Tampostat' in terms of arresting primary PPH with that of the conventional~     condom catheter.~   "
87938|NCT02416037|"~     Adequate PEEP selection in ARDS is still a matter of research. The main objectives of using~     PEEP in ARDS are improvement in oxygenation, lung recruitment at the end of expiration,~     prevention of opening and closing of terminal respiratory units at minimal hemodynamic~     compromise. The challenge is to carry out these objectives in a patient-centered approach~     based on individual characteristic of lung pathophysiology. Recently, it has been proposed to~     set PEEP from the trans-pulmonary end-expiratory pressure. Trans-pulmonary pressure (Ptp) is~     obtained from the difference between airway pressure and measured esophageal pressure (Pes).~     Measured Pes values have been found positive in the supine position in ARDS patients, leading~     to negative values of Ptp. The strategy proposed by Talmor and coworkers is to adjust PEEP up~     to get Ptp between 0 and 10 cm H2O. Whether this strategy improves survival is under~     investigation. Prone position ventilation significantly improves survival in severe ARDS as~     demonstrated by meta-analyses and a recent multicenter randomized controlled trial.~      The purpose of present project is to investigate Ptp at end-expiration in the prone position~     in severe ARDS. The project is centered on the question about what are the values of measured~     Pes in prone position. The hypothesis is that they are lower than in the supine position due~     to the relief of the weight of heart, mediastinum and lung and also to recruitment of dorsal~     lung regions. To investigate this hypothesis, measured Pes, Ptp, end-expiratory lung volume,~     overall lung recruitment (pressure-volume curve), and regional recruitment by using~     electrical impedance tomography. will be assessed in supine then in the prone position across~     two different strategies of PEEP selection, PEEP/FIO2 table and Talmor proposal.~   "
87939|NCT02416024|"~     Induction of general anesthesia to the patient could be a challenging period of anesthesia~     management. Due to autonomic system suppression, hemodynamic fluctuation, such as hypotension~     or hypertension, is commonly seen during this period. Furthermore, it has been observed that~     a fraction of patients who develop hypotension may be refractory to vasoactive medications to~     attempt to restore the systemic arterial blood pressure back to an acceptable level.~      Previous studies have shown that patients chronically taking angiotensin converting enzyme~     (ACE) inhibitors have a higher incidence of developing hypotension under general anesthesia~     as well as being refractory to adrenergic vasoconstrictor medications given to help restore~     systemic blood pressure. Interestingly, not all patients taking ACE inhibitors have shown the~     described hemodynamic response after induction of general anesthesia. Therefore,~     investigators are attempting to identify what changes in vascular physiology in those~     patients may contribute to acute refractory systemic hypotension. Specifically, investigators~     wish to explore whether differences in baseline levels of arterial stiffness potentially~     contribute to this phenomenon. Arterial applanation tonometry is a non-invasive technique~     that has been shown to reliably provide indices of arterial stiffness. In the proposed~     project, applanation tonometry will be performed on the right carotid and femoral arteries to~     assess carotid-femoral pulse wave velocity, a surrogate for aortic stiffness. (SphygmoCor~     system, AtCor Medical, Sydney, Australia) The measurement will be obtained before induction~     of general anesthesia in the pre-surgical area. During induction of general anesthesia with~     standard induction agents, brachial blood pressure will be measured by a cuff every minute up~     to 10 minutes after tracheal intubation. A hypotensive response to anesthesia will be defined~     by a systolic arterial blood pressure below 90mmHg upon induction. Hypotensive patients that~     do not respond to vasoconstrictor medications (i.e. requires more than 200 mcg phenylephrine~     to maintain systolic arterial blood pressure above 90 mmHg) will be classified as 'refractory~     hypotensive. Using non-invasive applanation tonometry, we will be able to examine if aortic~     stiffness has a propensity to become refractory hypotension after induction of general~     anesthesia. This information will potentially help identify future patients that might be at~     greater risk of developing refractory hypotension in response to induction of general~     anesthesia.~   "
87940|NCT02416011|"~     The purpose of this study is to develop and test a series of booklets designed to assist~     smokers of tobacco cigarettes who are also using e-cigarettes (dual users) in quitting~     smoking and remaining smoke-free.~   "
87941|NCT02415998|"~     The aim of this study is to assess whether transesophageal echocardiography (TEE) can be used~     to successfully guide an epidural catheter to a targeted thoracic level in pediatric~     patients. The catheter will be placed in the epidural space under real-time TEE imaging and~     assistance by a trained TEE operator (this could include an anesthesiologist or~     cardiologist).~   "
87942|NCT02415985|"~     To describe the pharmacokinetics of rifabutin 150 mg once daily versus rifabutin 300 mg~     thrice weekly in combination with LPV/r 400/100mg based HAART in HIV/TB infected patients~   "
87943|NCT02415972|"~     Stroke, a personal, familial, and social disaster, is the first cause of acquired disability,~     the second cause of dementia, and the third cause of death worldwide. Its associated~     socio-economic costs are astronomic. The burden of stroke is likely to increase, given the~     aging of the population and the growing incidence of many vascular risk factors. Therefore,~     apart from further development of stroke prevention and treatment strategies, rational and~     effective tools for diagnosis, monitoring, and follow-up for stroke patients have potential~     high long-term clinical and economic consequences.~      For neuroradiological work-up, computed tomography (CT) or magnetic resonance imaging (MRI)~     are used as gold standard techniques to detect presence or absence, effective state, and~     extent of stroke. However, these techniques achieve simply a baseline study of ischemia~     occurred and can deliver only a snapshot of brain parenchyma and vessels. Furthermore, their~     rapid and actual availability, especially in primary hospitals, and their dynamic~     capabilities and predictive values for further infarction are poor with critically ill~     patients have to be repeatedly transferred to the scanning unit for each measurement. Whereas~     CT examination is associated with x-ray radiation and may miss early detection of stroke, MRI~     is associated with higher costs and not generally routinely and around-the clock available in~     all the hospitals. Therefore, a simple, fast, repeatable, non-hazardous, and non-invasive~     dynamic bedside tool for the detection of acute brain tissue hypoperfusion and monitoring for~     potential further infarction or efficacy of thrombolysis either by systemic intravenous~     thrombolytic therapy with recombinant tissue plasminogen activator (rt-PA) or by selective~     intraarterial fibrinolysis and mechanical recanalization, both combined with or without~     bridging after acute ischemic stroke, is strongly needed.~      A promising alternative method of diagnosing stroke represents contrast-enhanced ultrasound~     perfusion imaging (UPI). What makes UPI so valuable is the advantage of repeatedly and~     non-invasively detecting brain tissue at risk for infarction by dynamic direct brain tissue~     perfusion assessment and not by surrogate parameters, like blood flow velocity or vessel~     diameter. Because of the possibility to screen and repeatedly measure the state of perfusion,~     the chances increase to diagnose and monitor ischemic stroke and to define the appropriate~     window for treatment. The perfusion analysis would also allow determination of treatment~     results and guidance of rapid and adequate further therapy.~      Therefore, the present pilot study in 40 patients is initiated. The objectives of this~     observational diagnostic cohort trial are to evaluate feasibility and practicability of~     repeated bedside assessments by contrast enhanced UPI in acute ischemic stroke patients and~     to assess whether UPI can detect alterations in brain tissue perfusion before and after~     recanalising therapy of strokes. Assessment of cerebral perfusion by CT or MRI serves as~     reference and its results are compared to UPI data.~   "
87944|NCT02415959|"~     The objective of this study is to assess the efficacy and safety of different doses of Creon~     Immediate Release (IR) in comparison to Creon® 25,000 Delayed Release/Gastro-Resistant~     (DR/GR) in subjects with Pancreatic Exocrine Insufficiency (PEI) due to Cystis Fibrosis (CF).~   "
87945|NCT02415946|"~     BACKGROUND Tooth loss impairs the OHRQoL. Dental implants have expanded treatment options of~     edentulous patients and improved their OHRQoL, however, in the posterior maxillary sextants~     the possibility to place implants of desired length and diameter could be limited. lSFE and~     tSFE represent two surgical options to vertically enhance the available bone in the~     edentulous posterior maxilla. Invasivity, relevant postoperative discomfort, high costs, and~     long times needed for the finalization of the prosthetic rehabilitation, however, strongly~     limit the indications of lSFE and support the need for less traumatic procedures with similar~     clinical effectiveness and reduced morbidity. In 2008, the investigators proposed a~     user-friendly, safe, predictable and effective minimally-invasive procedure for tSFE, namely~     the Smart Lift technique.~      AIMS/OBJECTIVES The general aim of the present project is to validate the Smart Lift~     technique as a simplified and minimally-invasive procedure for the implant-supported~     rehabilitation of patients with edentulous, atrophic maxillary posterior sextants.~      METHODS In a multicenter RCT study design, the reconstructive (clinical) and patient-centered~     outcomes of tSFE performed according to the Smart Lift technique will be compared with those~     of conventional lSFE.~      EXPECTED RESULTS The Smart Lift technique should allow for a significant reduction of~     treatment time, post-surgery complications and costs and an increase in the satisfaction~     perceived by the edentulous patient with implant-supported rehabilitation, while maintaining~     a clinical efficacy as well as a similar or lower morbidity and discomfort when compared to~     lSFE. In other words, the investigators expect that more favorable risk-benefit and~     cost-utility ratio, as well as a better performance in terms of pain, comfort, physical,~     social and psychological effects of oral health, and issues concerning the OHRQoL, will be~     observed for the Smart Lift technique compared to lSFE.~      List of Acronyms (in alphabetical order) OHRQoL: Oral Health - Related Quality of Life lSFE:~     sinus floor elevation with a lateral approach RCT: randomized controlled trial tSFE: sinus~     floor elevation with transcrestal approach~   "
87946|NCT02415933|"~     This study tests the effects of family-based economic empowerment intervention, alone and in~     combination with child rights sensitization component, on child protective outcomes among~     ultra-poor families in Nord Region, Burkina Faso.~   "
87947|NCT02415920|"~     This study investigates whether oxytocin, a neuropeptide known for its role in social~     bonding, influences the outcomes of persuasive communications and several primary~     evolutionary goals. Participants will be given either oxytocin or placebo on their first~     visit and then they will receive the other spray during their second visit. At each visit,~     participants will engage in several psychosocial tasks to assess the role of oxytocin on~     receptiveness to opposing opinions, navigating the spatial environment, mating and parenting~     goals. Participants' attitudes and behaviours will be compared across the different~     conditions.~   "
87948|NCT02415907|"~     The purpose of this study is to investigating the absorption, metabolism and excretion of~     radio labelled single doses of idalopirdine in healthy men.~   "
87949|NCT02415894|"~     The goal of this study is to examine the effectiveness and feasibility of a~     mifepristone-misoprostol medical abortion regimen in terminating pregnancies 13-22 weeks in~     Ukraine.~   "
87951|NCT02415868|"~     This purpose of this study is to collect vaginal microbial samples of postmenopausal women to~     assess the optimal conditions for cultivation and storage of the vaginal microbiota. These~     samples will subsequently be used to develop a high-throughput assay that mimicks the vaginal~     microbial community of postmenopausal women. This assay will be used to select and screen~     compounds that can affect the vaginal microbiota and subsequently affect related symptoms~     such as vaginal dryness.~   "
87952|NCT02415855|"~     Study Design:~      This is a multicentre, prospective, open-label, single arm, phase IV registry study. No~     additional procedures are included in the study. Standard clinical data will be collected.~     This will include a physical examination and NIHSS score assessment at baseline. In addition,~     all neuro-imaging will be collected. Standard imaging includes a non-contrast CT brain at~     baseline and 7±2 days post-treatment. Repeat NIHSS score assessment at the time of the 7 day~     CT scan. Repeat clinical and NIHSS score assessment 30 days post-enrolment will also be~     collected when performed as part of standard care.~      Study Objectives:~        1. Demonstrate the safety of early dabigatran initiation after minor stroke/TIA in patients~          with atrial fibrillation.~        2. Determine the frequency of asymptomatic hemorrhagic transformation after 7 days of~          dabigatran treatment following stroke/TIA~        3. Determine the effect of asymptomatic hemorrhagic transformation on functional and~          neurological outcome at 30 days.~   "
87953|NCT02415842|"~     The purpose of this exploratory, retrospective laboratory study is to assess the humoral~     immune response to H1 hemagglutinin stalk domain and other influenza A virus protein epitopes~     following administration, in adults and children, of GSK Biologicals' adjuvanted and~     unadjuvanted pandemic influenza vaccines, using archived serum samples from previously~     completed clinical trials.~   "
87954|NCT02415829|"~     The study aims to identify the efficacy and safety of capecitabine plus oxaliplatin (XELOX)~     in patients with local advanced colorectal cancer.~   "
87955|NCT02415816|"~     Children with sarcomas are routinely assessed with a variety of imaging techniques that~     involve the use of ionizing radiation. These include computed tomography (CT), nuclear bone~     scan, and positron emission tomography-CT (PET-CT). Pediatric sarcoma patients undergo many~     imaging studies at the time of diagnosis, during therapy and for years following completion~     of therapy. Because children are in a stage of rapid growth, their tissues and organs are~     more susceptible to the harmful effects of ionizing radiation than are adults. Furthermore,~     compared to adults, children have a longer life expectancy and, therefore, a longer period of~     time in which to develop the adverse sequelae of radiation exposure, such as the development~     of second malignancies.~      Alternative experimental methods of measuring tumor response will be compared to current~     standard of care measures to determine if the experimental method is equivalent to methods~     currently being used. Investigators wish to determine if they can reduce patient's exposure~     to the harmful effects of ionizing radiation by replacing imaging studies that use radiation~     with whole body diffusion weighted magnetic resonance imaging (DW-MRI) which does not use any~     radiation. They also want to know if DW-MRI measurements of the tumor can tell how well the~     tumor is responding to therapy. There have been studies in adults with cancer that have shown~     that DW-MRI provides useful information about how tumors are responding to therapy. There~     have only been very small studies of DW-MRI in children with tumors in the body. Therefore,~     the role of DW-MRI in pediatric sarcoma patients is not yet known and it is still~     experimental. This study might give us important information that could help us treat other~     children with bone or soft tissue sarcomas in the future.~   "
87956|NCT02415803|"~     Ticagrelor is an oral, reversibly-binding, direct-acting P2Y12 receptor antagonist used~     clinically for the prevention of atherothrombotic events in patients with acute coronary~     syndromes (ACS). Guideline recommendations on the use of dual antiplatelet therapy (DAPT)~     have been formulated that ticagrelor 90 mg twice daily plus aspirin in preference to~     clopidogrel 75mg daily plus aspirin for patients who have an ACS with or without ST-segment~     elevation. These recommendations are primarily based on large, randomized, Phase III clinical~     trials. However, few East Asian patients (or those of East Asian descent) have been included~     in these trials to assess the use of these drugs. In addition, a growing body of data~     supported that East Asian might have different adverse event profiles (thrombophilia and~     bleeding) and therapeutic window compared with white subjects. Furthermore, East Asian~     paradox phenomenon has been described that East Asian patients have a higher prevalence of~     platelet reactivity during DAPT, but an ischaemic event rate following PCI or ACS is similar~     or even lower than white patients. Therefore, the antiplatelet treatment strategy that is~     most appropriate for East Asian patients is increasingly urgent. Therefore, we performed the~     current study to observe the different effects of low-dose ticagrelor (45 mg twice daily),~     conventional-dose ticagrelor (90 mg twice daily) and clopidogrel (75mg once daily) on high~     platelet reactivity (HPR) and IPA, and investigated the safety and efficacy of low-dose~     ticagrelor further in Chinese patients with non-ST-elevation ACS (NSTE-ACS).~   "
87957|NCT02415790|"~     This first-in-human study, designed to assess the safety, tolerability, and pharmacokinetics~     (PK) of single oral ascending doses of E2027, will be administered to healthy adult~     participants to determine the maximum tolerated dose (MTD). Thereafter, the pharmacodynamic~     (PD) effects of single doses of E2027 on elevation of cerebrospinal fluid (CSF) cyclic~     guanidine monophosphate (cGMP) in healthy adult participants will be evaluated across a broad~     dose range, to establish the PK/PD relationship.~   "
87958|NCT02415777|"~     A multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy~     and safety of 'URSA SOFT CAP. (UDCA-003)' in fatigue patients with liver dysfunction~   "
87981|NCT02415478|"~     For patients with emphysema, lung volume reduction by insertion of endobronchial valves could~     be an expedient approach to improve the diaphragm function and the strength of breathing~     muscles. Therefore in the present study investigators intend to examine, whether the lung~     volume reduction by valves might improve the physical capacity and the quality of life.~   "
87982|NCT02415465|"~     Purpose: Compare continuous adductor canal block (CACB) to Combined Spinal Epidural (CSE) for~     total knee arthroplasty in terms of mobility, post-operative pain, and analgesic use.~      Hypothesis: CACB will provide better mobility than CSE post operatively.~   "
88598|NCT02407444|"~     This study aims to evaluate whether a combination of cycling training as part of~     physiotherapy treatment will contribute more than conventional physiotherapy treatment for~     elderly patients after hip fracture surgery in their subacute phase of rehabilitation.~   "
87959|NCT02415764|"~     Our team will develop a prototype game (OnTrack>The Game) in which users play the role of a~     person who has experienced First Episode Psychosis and move through animated role-playing~     scenarios, learning practical tips for engaging in care, playing mini-games to develop self-~     advocacy skills, and seeing stories of hope and recovery (brief video vignettes). The game is~     designed in an engaging comic book style in which the player is presented with realistic~     situations designed to promote engagement and the development of trusting relationships.~      Following development of the prototype, the investigators will conduct a pilot study to~     develop preliminary data to determine feasibility of a large-scale Phase 2 effectiveness~     study. This pilot study aims to demonstrate proof of concept for OnTrack>The Game. The~     investigators will recruit a sample of patients/consumers (n=25) from OnTrackNY sites that~     offer services for those experiencing their first psychotic episode. Quantitative data will~     be collected through baseline and follow up surveys that utilize instruments to measure~     knowledge and attitudes about recovery, perceptions of stigma, feelings of empowerment and~     sense of hopefulness. The investigators will also conduct semi-structured interviews with a~     subset of participants to explore engagement in treatment and attitudes toward the game.~   "
87960|NCT02415751|"~     This study is assessing the effects of a new heart failure self-care education program in the~     Nebraska Heart Institute Heart Improvement Clinic. The new education program will consist of~     an initial intensive self-care education session with the Principal Investigator or her nurse~     practitioner. Topics to be discussed include medications, sodium and fluid consumption,~     alcohol restriction, exercise, preventive behaviors, and monitoring of signs and symptoms. As~     recommended in the ACCF/AHA guidelines, this education will be repeated on an annual basis as~     studies have shown that the impact of HF education is not always durable and must be a~     continual process. This study will assess the impact of this review on their medication~     knowledge, disease state knowledge, quality of life, disease state progression and clinical~     outcomes such as ejection fraction and number of hospitalizations.~   "
87961|NCT02415738|"~     Hypoxemia may be refractory to protective ventilation during the acute respiratory distress~     syndrome (ARDS), justifying the use of other therapies that improved oxygenation and~     decreased mortality, including prone position (PP).~      During ARDS, the majority of patients are responders to PP with increased PaO2 due to~     homogenization of the ventilation-perfusion ratio. Despite changes in intra-thoracic and~     intra-abdominal pressure, hemodynamic parameters are not changed.~      Besides the fact that the PP improves systemic oxygenation is it the same on cerebral~     oxygenation? No study has investigated the cerebral oxygenation during PP in patients with~     ARDS. The cerebral oxygenation may be altered due to the position of the patient and high~     levels of positive end-expiratory pressure. This decrease oxygenation may be responsible for~     cognitive impairment when patients awake.~      NIRS (Near Infrared Spectroscopy) is a noninvasive tool, capable of delivering information on~     cerebral oxidative metabolism and its hemodynamic status. It can be used routinely for the~     management of resuscitation in Intensive Care Unit (ICU) patients. This study is to~     investigate cerebral oxygenation during prone position in the investigators' patients of ICU.~   "
87962|NCT02415725|"~     Many clinical situations in oncologic surgery imply the need to dissect more or less~     extensively lymph node stations which are in direct relation with the lymphatic drainage of~     the anatomical region affected by cancer.~      The dissected lymph nodes drain generally several regions, and their dissection reduces then~     the drainage capacity of all these regions, increasing the risk for the patient to develop a~     secondary lymphedema, shorter or longer after surgery.~      Efficient treatments exist, but are difficult to implement and to continue for a long~     time.The later the treatment of the lymphedema begins, the heavier it is, both on the medical~     and socio-economic level.~      The lymphofluoroscopy, shows that some oncologic patients, operated and free of apparent~     secondary lymphedema, present abnormalities of the lymphatic network.~      The present study aims to confirm that it is now possible to detect secondary lymphedema at a~     subclinical stage.~   "
87963|NCT02415712|"~     The objective of this survey is to evaluate the safety and efficacy of fomepizole intravenous~     infusion in Japanese patients with ethylene glycol and methanol poisonings in daily medical~     practice.~   "
87964|NCT02415699|"~     Stage III colorectal cancer constitutes more than half of the colorectal patients, and the~     prognosis does not improve much recently although varies of adjuvant drugs have been tried.~     DC-CIK immunotherapy has been proved to improve survival in cancer patients, but its role in~     stage III colorectal cancer patients stains unclear. The investigators study will focus on~     the efficacy and safety of DC-CIK immunotherapy plus chemotherapy in the adjuvant treatment~     of stage III colorectal cancer, compared with chemotherapy alone.~   "
87965|NCT02415686|"~     SUMMARY~      Rationale:~      People with Dravet Syndrome (DS), a rare epilepsy syndrome, have a high risk of Sudden~     Unexpected Death in Epilepsy (SUDEP). Mouse models indicated that the responsible sodium~     channel mutation (SCN1A) not only alters cortical excitability but also increases the~     propensity to arrhythmias. Little is known yet about the prevalence of seizure-induced~     arrhythmias in human DS subjects.~      Objective:~      To assess the prevalence of cardiac arrhythmias in DS and to compare the prevalence of~     cardiac arrhythmias between DS subjects and subjects with other types of epilepsy.~      Study design:~      Observational study.~      Study population:~      Subjects with Dravet syndrome and a known pathogenic SCN1A mutation, seizure frequency ≥~     1/week (all seizure types except for absences or myoclonias), age ≥ 6 years and no signs of~     self-harm. Each case will be matched to two historical controls (age +/- 5 years) from the~     EEG databases of the participating centres. Only those controls with two or more recorded~     seizures will be matched to the cases.~      Intervention:~      Main study parameters/endpoints:~      Ictal asystole Ictal bradycardia Ictal QT-shortening/lengthening~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness:~      Participation does not carry risks. The sensor is wearable and miniaturised, thus minimising~     discomfort. If this nevertheless may occur, the study can be terminated. This study provides~     specific tools to investigate the seizure-related heart rate response. Subjects may thus~     benefit from participation by identification of otherwise unknown arrhythmias. The rationale~     of the study (the high SUDEP risk and the evidence in animal studies for arrhythmic cause of~     sudden death) specifically applies to DS, a rare epileptic syndrome including minors and~     incapacitated persons. The investigators believe that the lack of risks, the potential~     diagnostic benefit, the minimal intervention with novel and wearable sensors and the~     possibility to terminate the study in case of discomfort, justifies the study in this patient~     group.~   "
87966|NCT02415673|"~     The aim of the present study was to compare the effectiveness of two alignment sequences with~     thermal activated archwires with different Af temperatures applied for the correction of~     mandibular anterior crowding~   "
87967|NCT02415660|"~     This study will assess the short term response of thoracic spinal manipulation with or~     without trigger point dry needling in 58 subjects with a primary complaint of mechanical neck~     pain.~   "
87969|NCT02415634|"~     The complexity of critical illness can result in both physical and psychological consequences~     for survivors, which can extend past the intensive unit care stay and after hospital~     discharge. A need for information and empowerment in the recovery process are highlighted for~     developing treatment strategies. It is suggested that there is a relationship between~     physical problems and psychological symptoms, but this has not been researched. This pilot~     study aims to test the effectiveness of a physiotherapy directed Rehabilitation after~     Critical illness Assisted discharge Pack (RECAP) on the physical and psychological function~     of patients recovering from critical illness in the first three weeks post discharge from ICU~     to the general ward area. The study will rely on a randomized controlled clinical trial~     design, with patients assigned to either a usual care control group vs. the treatment~     group. It is expected that engaging patients in their rehabilitation plan will focus~     physiotherapy treatment and improve physical recovery. It is hypothesized that the RECAP will~     reassure, support and empower patients to directly affect their psychological recovery in the~     first three weeks after critical illness.~   "
87970|NCT02415621|"~     Abiraterone is approved in the United States by the U.S. Food and Drug Administration (FDA)~     to treat metastatic prostate cancer at 1000 mg daily.~      The purpose of this study is to find out if an on and off schedule of taking abiraterone~     would prolong the participant's cancer's response to this drug and maintain their~     functionality to perform their daily activities.~   "
87971|NCT02415608|"~     This phase II trial studies ibrutinib to see how well it works in treating patients with~     systemic (affecting the entire body) mastocytosis that has spread to other parts of the body~     and usually cannot be cured or controlled with treatment (advanced). Systemic mastocytosis is~     a disease in which too many mast cells (a type of immune system cell) are found throughout~     the body. Mast cells give off chemicals such as histamine that can cause flushing (a hot, red~     face), itching, abdominal cramps, muscle pain, nausea, vomiting, diarrhea, low blood~     pressure, and shock. Ibrutinib may stop the growth of mast cells by blocking some of the~     enzymes needed for cell growth.~   "
87972|NCT02415595|"~     The purpose of this study is to find at least one dose of BMS-955176 that will be safe,~     effective and tolerable for HIV-1 infected treatment naive adults.~   "
87973|NCT02415582|"~     The purpose of this study is to compare the effects of two exercise protocols on~     post-exercise blood pressure versus a control group in elderly hypertensive men. Participants~     are allocated to all groups: control group and two experimental exercise protocols, in a~     random order. In the control group, participants remain resting sitting, and, in the exercise~     protocols, participants practice exercise bouts of aerobic exercise or a combination of~     resistance and aerobic exercises. In order to standardize baseline conditions, before the~     sessions subjects remain sitting quietly for 20 minutes. After each exercise protocol,~     participants have 60 minutes for recovery and, simultaneously, they have BP measured every 5~     minutes. After the exercise sessions or control, an equipment for 24 hours ambulatory BP~     monitoring is installed in every participant.~   "
87974|NCT02415569|"~     The Bristol stool form scale ( BSFS) based tailored bowel cleansing regimen might be helpful~     to improve bowel cleansing quality before colonoscopy.~   "
87975|NCT02415556|"~     The main purpose of this study is to find the long-term effects of daily administration of 40~     IU of intranasal insulin (INI) as compared to placebo (sterile saline) on cognition and~     memory in people with type 2 diabetes mellitus (DM), and non-diabetic controls over 24 weeks~     with a follow-up period for 24 weeks. Four groups will be tested: DM group treated with INI;~     DM group treated with placebo; control group treated with INI and the control group treated~     with placebo. The INI or placebo will be delivered into the nose. The investigators are~     interested to see whether INI can improve memory and cognition and blood flow in the brain in~     the type 2 DM group as compared to placebo and to the non-diabetic group over a long-term~     period.~   "
87976|NCT02415543|"~     This study aim to compare the efficacy and safety of Single incisional Laparoscopic Total~     Extraperitoneal(SIL-TEP) Inguinal Hernia Repair and traditional Laparoscopic Total~     Extraperitoneal(TEP) Inguinal Hernia Repair in day surgery. This study also aim to improve~     the surgical-related technical details and the device design.~      In addition, this study also evaluate the operability of SIL-TEP in term of a day surgery~     item and try to provide the basis for SIL-TEP day surgery guildline, so as to promote the~     SIL-TEP technology in the investigators country.~   "
87977|NCT02415530|"~     This is randomized controlled trial investigating the effect of early intervention in very~     low birth weight infants after discharge from NICU on neurodevelopmental outcome. Other than~     control group of VLBW infants, study population includes term infants to compare~     neurodevelopmental outcome.~   "
87978|NCT02415517|"~     The daily routine in clinical settings often showed cognitive impairments in patients with~     congestive heart failure, particularly in terms of executive functions, episodic memory,~     perceptual speed and attention. It is assumed that cognitive impairments in patients with~     congestive heart failure may lead to deficits in medication-adherence and self-care~     abilities, resulting in increased healthcare costs. Recent studies reported performance~     improvements after cognitive training that transferred to new, untrained tasks and abilities~     in healthy subjects across a wide range of ages. This study investigates the effects of~     cognitive training in patients with congestive heart failure.~   "
87979|NCT02415504|"~     This pilot study examines the impact of an enhanced care transition process vs. usual care~     for persons with dementia admitted to a transitional unit (hospital or LTC) for management of~     behavioural and psychological symptoms of dementia (BPSD) with a planned discharge to long~     term care (LTC) facilities or other hospital units. Deficiencies in discharge processes can~     contribute to poor outcomes (e.g., readmissions), and there is a dearth of research on how to~     improve care transitions for persons with BPSD. The investigators aim to improve the care~     transition process for persons with dementia and BPSD utilizing an enhanced care transition~     process that will contain up to 6 elements: integrated behavioural care plans, videos,~     patient specific briefcase containing activities to reduce BPSD, in-person care transition~     meeting, in-person care demonstration (when possible), and follow up visits with a transition~     team. The ability to determine the effect of enhanced care transitions on the clinical course~     of patients with planned discharge to LTC or hospital may allow for improved outcomes and an~     overall increased efficiency of post discharge care.~   "
87983|NCT02415452|"~     This study is to investigate the relationship between staging of retinal artery lesions and~     the prognosis of acute coronary syndrome (ACS) in a Chinese population. All the patients were~     divided into four groups according retinal artery lesions.The endpoints were main adverse~     cardiovascular and cerebrovascular events (MACCE), including all-cause death, myocardial~     infarction (MI), and stroke after 3 to 6 years of follow-up.~   "
87984|NCT02415439|"~     The purpose of this study is to examine the safety, tolerability, and PK of various~     increasing single and multiple doses of VBP15 in healthy adult subjects.~   "
87985|NCT02415426|"~     The participants of this study have been diagnosed with mild to moderate depression with no~     evidence of suicidal actions prior to recruitment. All recruited subjects receive standard~     therapy and participate in a metacognitive training program (D-MKT) independently of study~     participation. Diagnostic and therapeutical interventions are not part of this study. As part~     of this study, the change of cognitive and psychosocial achievement/behavior in patients with~     mild to moderate depression after taking part in the training program is being investigated.~     The training program seeks to enable group members to recognize and correct the often~     automatic and unconscious thought patterns that accompany depression, in part by viewing this~     depressive thought process at a distance (i.e., depersonalizing). In addition, dysfunctional~     assumptions about one's thought processes, as well as dysfunctional coping-strategies (i.e.,~     thought suppression, rumination as problem-solving) are targeted (Lena Jelinek & Steffen~     Moritz, http://clinical-neuropsychology.de/metacognitive_training_for_depression.html).~     Within this study the cognitive and psychosocial behaviour changes are being investigated by~     neuropsychological assessment as well as questionnaires.~   "
87986|NCT02415413|"~     Patients included in the study will receive induction treatment during 6 months, followed by~     receive high-dose therapy followed by peripheral blood stem cell transplantation.~      Approximately 3 months after peripheral blood stem cell transplantation patients will receive~     consolidation treatment during 2 months.~      Subsequently patients will start maintenance treatment during 24 months. Therefore, the total~     duration of the treatment will be approximately 36 months.~   "
87987|NCT02415400|"~     The purpose of this study is to determine if Apixaban is safer than a Vitamin K Antagonist~     given for 6 months in terms of bleeding in patients with an irregular heart beat (atrial~     fibrillation) and a recent heart attack or a recent procedure to open up a blood vessel in~     the heart. All patients would also be taking a class of medicines called P2Y12 inhibitors~     (such as clopidogrel/Plavix) and be treated for up to 6 months. The primary focus will be a~     comparison of the bleeding risk of Apixaban, with or without aspirin, versus a Vitamin K~     antagonist, such as warfarin, with or without aspirin.~   "
87988|NCT02415387|"~     This randomized clinical trial uses an inactive typhoid vaccine to briefly stimulate an~     immune response in patients with stage I-IIIA breast cancer who received primary cancer~     treatment and studies whether patients' fitness levels affect how their bodies handle a~     challenge to their immune system. A vaccine is a substance or group of substances meant to~     cause the immune system to respond to a tumor or to microorganisms such as bacteria or~     viruses. Immune responses may cause excess inflammation in the body and behavioral changes,~     such as depression, fatigue, pain, and problems with thinking and reasoning. Studying immune~     responses in patients with breast cancer who have undergone primary cancer treatment may help~     doctors learn whether physical fitness can protect the body from effects of immune system~     stress and whether it may be able to reduce health problems in patients with breast cancer.~   "
87989|NCT02415374|"~     The purpose of the study is to examine whether orally ingested oat avenanthramides (AVA) in~     oat flour cookies are bioavailable in humans by measuring plasma and urine concentrations of~     AVAs and their potential metabolites after ingestion. The blood and urine concentrations will~     be quantified at several different time points after the oat flour cookies are consumed to~     characterize the concentration-time profile.~   "
87990|NCT02415361|"~     In Norway, 100-120 children are born with CLP (1.9 per 1,000 live births) each year. Parents~     of infants with CLP need information and support, especially with feeding immediately after~     birth. These needs are often not met. The purpose of this study is to investigate the effect~     of systematic follow ups of parents with infants with CLP performed by a special trained~     nurse. Parental information needs, parental coping and stress and infant growth and feeding~     will be explored and compared to a control group receiving standard care. 26 parents (mothers~     and fathers) or more shall be included in each group according to specific criteria. The~     control should be examined first. Both groups will answer questionnaires 3 times during the~     child's first year.~   "
87991|NCT02415348|"~     This study is designed to determine if the Fibroscan (Echosens, Paris), a non-invasive,~     ultrasound-based device used to estimate fibrosis in patients with chronic liver disease,~     interferes with implanted cardiac pacemaker and/or implantable cardioverter-defibrillators.~     Recruitment consists of a total of 200 outpatients undergoing routine pacemaker interrogation~     at a teaching-hospital pacemaker clinic.~   "
87992|NCT02415335|"~     For elective abdominal surgery preoperative administration of 8 mg dexamethasone reduces the~     incidents of postoperative nausea and vomiting (PONV). Whether preoperative administration of~     8 mg dexamethasone reduces PONV for patients having acute abdominal surgery has not been~     established. The investigators wish to see if preoperative administration of 8 mg~     dexamethasone minimum 30 minutes prior to a diagnostic laparoscopy for suspected appendicitis~     will reduce the incidents of PONV by 50%. Of secondary interest the investigators want to see~     if 8 mg dexamethasone preoperative can reduce pain, reduce opioid consumption, postoperative~     fatigue, duration of time until resumption of work and resumption of normal daily activities,~     and enhanced the quality of recovery.~   "
87993|NCT02415322|"~     The aim of this cohort study is to observe the prevalence, incidence, relapse, and remission~     rates of online and/or smartphone game addiction among elementary and secondary school~     students in Korea. In addition the investigators are going to identify risk and protective~     factors, to determine whether online and/or smart phone game addiction is a primary or~     secondary problem, and to identify outcomes for individuals who become or stop being online~     and smart phone game addiction.~   "
88006|NCT02415153|"~     This phase I trial studies the side effects and best dose of pomalidomide in treating younger~     patients with tumors of the brain or spine (central nervous system) that have come back or~     are continuing to grow. Pomalidomide may interfere with the ability of tumor cells to grow~     and spread and may also stimulate the immune system to kill tumor cells.~   "
87994|NCT02415309|"~     Lumbar medial branch blocks are commonly used as a diagnostic tool for facet-mediated chronic~     low back pain. This interventional pain procedure often occurs in the fluoroscopy suite.~     During this procedure, a physician inserts the needles to deliver local anesthetics such as~     lidocaine or bupivacaine to the nerves which innervate the lumbar facet joint. Many patients~     experience anxiety before and during the lumbar medial branch block procedure and require~     intravenous midazolam or fentanyl for sedation. Intravenous or conscious sedation requires~     one-to-one nursing care, monitoring, and recovery. In order to minimize the costs and time~     requirements of intravenous sedation, a suitable oral medication which is readily available~     and non-controlled would be ideal. Several randomized double-blinded, controlled trials have~     investigated the anxiolytic effects of melatonin before a surgery; however no studies to date~     have studied the anxiolytic effects of melatonin before less invasive interventional pain~     procedures. This study is designed to evaluate the efficacy of melatonin for reducing anxiety~     in patients undergoing a lumbar medial branch block procedure.~      The study is a randomized, double-blinded, placebo-controlled trial with 40 patients in each~     group: 2 mg melatonin, 10 mg melatonin and placebo. The primary outcome is anxiety reduction~     in patients before undergoing the procedure. The primary outcome is measured by visual~     numerical rating scale for anxiety and the Amsterdam Preoperative Anxiety and Information~     Scale. Based on the results of previous studies, the investigators hypothesize that melatonin~     may reduce anxiety in patients undergoing the procedure and be a suitable alternative to~     intravenous sedation in the pain clinic for patients undergoing lumbar medial branch blocks.~   "
87995|NCT02415296|"~     The Internet medium is particularly vector for gambling problems. Since the opening of the~     online gambling sector in France, no screening for excessive gambling behaviours is provided~     for by the law, although it is known that preventive actions are more effective if they are~     implemented early in the gambler's career.~      The investigators propose to develop a model for screening excessive gambling practices based~     on the gambling behaviours observed on French gambling websites, coupled to a clinical~     validation. The objective is to lead to early preventive measures directed towards the more~     vulnerable gamblers and adapted for each type of gambling.~      This study will therefore contribute to setting up an innovative measure of prevention, to~     inform and protect gamblers as early as possible.~   "
87996|NCT02415283|"~     The Exalenz clinical investigation is a multicenter, non-randomized, study of the~     ¹³C-Octanoate Breath Test (OBT). The present study is a feasibility trial, which aims to~     evaluate the capability of the OBT to differentiate between presence and absence of HCC~     determined by Magnetic Resonance Imaging (MRI) in patients with chronic liver disease.~   "
87997|NCT02415270|"~     The overall objectives of this clinical study are to determine in smokers the short term~     effects of switching to tobacco products that deliver low levels of nicotine or reactive~     oxygen/nitrogen species (ROS/RNS) on smoking behavior and biomarkers of tobacco smoke~     exposure and oxidative stress.~   "
87998|NCT02415257|"~     The purpose of the study is to determine whether vestibular and postural compensation~     following schwannoma surgery is improved by ablating vestibular function prior to surgery,~     even if vestibular function is absent according to modern assessment techniques~   "
87999|NCT02415244|"~     The aim of this prospective observational study is to assess whether transesophageal~     echocardiography (TEE) can be used to identify the structures within the vertebral foramen of~     the spinal column and to determine the range of spinal segments which can be visualized.~   "
88000|NCT02415231|"~     The study is to see if watching humor and laughing can affect CRP levels in healthy~     individuals. This is a randomized controlled trial.~   "
88001|NCT02415218|"~     The study purpose is to evaluate the efficacy and safety of cultivated oral mucosal~     epithelial sheet transplantation as a novel therapy for limbal stem cell deficiency, for~     which no effective approaches has thus far been available, for the purpose of establishing~     this therapy as an effective strategy for this disease with an aim of improving visual acuity~     and corneal transparency.~   "
88002|NCT02415205|"~     The study will measure the effects of eye exams on markers of stress in the urine. In~     addition, measurements will be taken to show the effects of stress on brain activity, O2~     sats, and blood flow.~   "
88003|NCT02415192|"~     Levacalm Tab. was approved in Jul 2013 by MFDS in South Korea. Levacalm Tab. is combination~     drug of Valsartan as an angiotensin II receptor blocker and Lercanidipine as a Calcium~     channel blocker. It is a new drug of combination of Valsartan and Lercanidipine. Thus,~     there's no enough safety data and efficacy data defined from the clinical study.~      Also, many combination drugs of valsartaa and amlodipine are widely used in the market.~      LGLS will compare the safety(adverse events especially the lower leg edema) and efficacy~     (blood pressure and pulse) of Levacalm and Valsartan/amlodipine combination drug from this~     study.~   "
88004|NCT02415179|"~     The purpose of this study is to investigate the effectiveness of inhaled~     mometasone/formoterol versus inhaled fluticasone/salmeterol on peripheral airway function in~     treatment of asthma.~   "
88005|NCT02415166|"~     The aim of this project is to evaluate the efficacy of the influenza vaccine in individuals~     with major depressive disorder (MDD) as well as to elucidate the nature of the immunological~     abnormalities in MDD using a quasi-experimental design. Specifically, the investigators plan~     to induce transient, mild inflammation in medically-healthy study participants using the~     influenza vaccine. Initially the investigators will conduct a pilot project with up to 20~     individuals in order to evaluate the time-point at which the peak inflammatory response to~     the vaccine occurs. Subjects will receive the seasonal influenza vaccine and provide blood~     samples 4 hours, 2 days, and 30 days post vaccination. Subsequent to the pilot study, both~     depressed and psychiatrically-healthy participants will be randomized in a parallel group,~     double-blind design so that they receive either influenza vaccine (seasonal vaccine) or~     saline (i.m). At baseline, subjects will provide a blood sample, complete a number of rating~     scales to measure mood and fatigue, and may complete approximately one hour of MRI scanning~     with or without simultaneous EEG recording. Two-days post vaccination, they will provide a~     second blood sample, complete more clinical ratings and may complete another identical MRI~     session with or without simultaneous EEG. Four weeks later, participants will be asked to~     return to provide a third blood sample and complete additional clinical ratings. The blood~     samples will be used to measure both innate and adaptive immune function and may be used to~     correlate the vaccine-induced immunological changes to neurophysiological changes in the~     brain measured by MRI and/or EEG.~   "
88007|NCT02415140|"~     Depression adversely affects quality of life in COPD patients, associated with higher rate of~     exacerbations, admissions and mortality. However, local prevalence rate of depression in~     geriatric COPD patients remains unknown.~      Though BODE index is superior to FEV1 in prediction of depression in COPD, it is unclear~     which domain of BODE correlates best with depression. Furthermore, with multiple confounding~     factors, it's ambiguous that whether frequent exacerbation is an 'independent' predictor for~     depression among COPD patients.~      The objective of this study is i.) to study the local prevalence rate of depression in~     geriatric COPD patients, ii.) to identify risk factors for depression especially looking at~     the any independent relationship between frequent exacerbations, various domains of BODE~     index and depression.~   "
88008|NCT02415127|"~     The purpose of this phase 3 randomized, multi-center, double-blind, placebo-controlled study~     is to evaluate the efficacy and safety of ACTIMMUNE® (interferon-γ 1b) in the treatment of~     Friedreich's Ataxia (FA) and to evaluate the pharmacokinetic (PK) characteristics of~     ACTIMMUNE® in FA patients.~   "
88009|NCT02415114|"~     The primary objective of this study is to assess the blood levels of Coenzyme Q10 in healthy~     subjects when administered Omega Q Plus® Resveratrol for 28 days.The secondary objective of~     the study is to determine if statin use has an impact on the blood levels of Coenzyme Q10~     when administered Omega Q Plus® Resveratrol for 28 days. The safety objectives will include~     assessment of safety evaluations as determined by:~        -  laboratory tests - CBC, electrolytes (Na, K, Cl), glucose, creatinine, AST, ALT, GGT,~          and bilirubin~        -  vital signs - heart rate and blood pressure~        -  adverse events~   "
88010|NCT02415101|"~     This study compares outcomes with regard to the timing of resective surgery after neoadjuvant~     chemoradiotherapy (CRT) in cancer of the esophagus or gastric cardia. Patients are randomised~     to surgery either conventional 4-6 or 10-12 weeks after termination of CRT. The study~     hypothesis is that a longer delay improves histological response and decreases the risk of~     postoperative morbidity and mortality.~   "
88011|NCT02415088|"~     This is a randomised, observer-blinded trial to compare selective shoulder block with~     interscalene block. Both blocks will be placed using an ultra-sound guided technique.~      Primary outcome measures will be postoperative pain scores and use of rescue opioids.~     Secondary outcome measures will be pre- and postoperative occurence of motor deficit of the~     arm and dyspnea, quality of sleep in the first night after surgery as measured by a numeric~     rating scale and overall satisfaction with pain therapy as measured by the International Pain~     Outcomes questionnaire and an NRS-score (0 = not satisfied at all and 10 = very satisfied).~      Primary and secondary outcome measures will be assessed during the first 24hours after~     surgery (assessment in the postanesthetic care unit (PACU) directly after admission and~     before discharge and in the surgical ward at 4, 8 and 24 hours after surgery).~      Overall satisfaction with pain therapy will be assessed 48hours after surgery.~      An interscalene block is a block of the plexus brachialis in the interscelene triangle (by~     injecting a local anesthetic around the nerve plexus).~      A selective shoulder block is a block of the suprascapular and axillary nerves (by injecting~     a local anesthetic around these nerves).~   "
88012|NCT02415075|"~     The purpose of the study is to determine which factors on a personal, social and contextual~     level will help rehabilitation patients on returning to or continuing to work as well as to~     stay employable.~   "
88013|NCT02415062|"~     The purpose of this study to evaluate the safety and efficacy of high-dose donepezil (23mg)~     in Parkinson's disease with dementia compared to standard dose donepezil.~   "
88014|NCT02415049|"~     There are several choices to consider when determining the timing of initiation of enteral~     feeds following a pyloromyotomy. Some practice patterns have initiated feedings as soon as~     the infant awakens from anesthesia. Some authors have suggested a period of withholding~     feedings for several hours postoperatively, while others have recommended a significantly~     longer period of starvation (18 hours) before initiating feedings. The ongoing debate arises~     over whether a physician chooses a standardized, incremental feeding regimen versus an ad~     libitum feeding schedule which allows the infant to decide when and how much to eat. Neither~     has been studied effectively in a randomized controlled setting. A recent review of the~     literature would suggest that a period of 4 hours of NPO, followed by ad lib feedings may be~     the best postoperative regimen. This however, has not been studied in a randomized,~     controlled trial.~   "
88015|NCT02415036|"~     This is a two arm, open label, multi-center, Phase 2 study to evaluate the efficacy and~     safety of Melphalan/HDS in patients with unresectable Hepatocellular Carcinoma (HCC) or Intra~     Hepatic Cholangiocarcinoma (ICC) confined to the liver.~   "
88016|NCT02415023|"~     An open-label, dose escalation and maximum tolerated dose (MTD) and/or recommended phase II~     dose (RPTD) study of fruquintinib combined with paclitaxel in patients with advanced gastric~     cancer who did not respond to first-line standard chemotherapy.~   "
88017|NCT02415010|"~     The objective of this Post-Market Clinical Follow-up (PMCF) is to confirm the performance and~     safety of the Codman Enterprise® 2 when used in conjunction with endovascular coil~     embolization of ruptured or non-ruptured intracranial aneurysms.~   "
88018|NCT02414997|"~     The purpose of this study is to determine the effect of remote ischemic preconditioning~     (RIPC) on blood pressure and its vascular protection effect among Chinese young healthy~     adults and primary hypertensive patients stage I.~   "
88019|NCT02414984|"~     The purpose of this study is to describe adherence to golimumab in Colombian participants~     with rheumatoid arthritis (RA) experiencing adequate treatment response, in a real-world~     clinical settings.~   "
88030|NCT02414841|"~     This research study is designed to assess the safety and effectiveness of an experimental~     drug called vonapanitase (PRT-201) in patients both receiving or expecting to receive~     hemodialysis who have chronic kidney disease and who are undergoing surgery to create a new~     access point to their bloodstream for hemodialysis. Vonapanitase is a protein that has been~     shown in previous research studies to help keep vessels patent when applied to the outside~     surface of the blood vessels (arteries and veins) in patients who undergo surgery to create~     an arteriovenous fistula (AVF). The purpose of this study is to determine whether~     vonapanitase when applied to a limited segment of your blood vessel (about 2 inches)~     immediately after surgery is safe and improves the patency of your AVF.~   "
88020|NCT02414971|"~     Project Study: Pilot Human Study Specific Aims: 1. describe levels of mitochondrial~     respiratory enzymes 2. examine relationships between levels of mitochondrial enzymes,~     fatigue, and health-related quality of life; and 3. compare levels of mitochondrial enzymes~     in men with a clinically-significant change in fatigue from those with no change in fatigue.~      Significance of Study: Cancer related fatigue is a common side effect of cancer. Cancer~     related fatigue is poorly understood. Many different biological mechanisms have been~     theorized, including mitochondrial dysfunction. Self-reported descriptions of reduced energy~     and muscle weakness lend support for a possible relationship of cancer related fatigue to~     mitochondrial dysfunction.~      Main Research Variables: Mitochondrial Enzymes, Cancer related fatigue, and health related~     quality of life Design: Descriptive, longitudinal study Sample/Setting: Men with~     non-metastatic prostate-cancer who are scheduled to receive radiation therapy Methods:~     Questionnaires, mouth swabs and blood will be collected at four study visits: prior to~     treatment, midpoint of treatment, completion of treatment and within 90 days of finishing~     treatment. Four mouth swabs will be collected per participant at each study visit.~      Implications for Practice: Understanding the role of mitochondrial enzymes in cancer related~     fatigue has major clinical implications in the development of targeted interventions and in~     providing specific knowledge for patients and their families to make informed treatment~     decisions.~   "
88021|NCT02414958|"~     Comparison of 2 doses of empagliflozin vs placebo in patients already using either an insulin~     regimen of MDI or CSII. Randomisation to 3 treatments arms (equal assignment) following a~     screening period, an optimisation period and a run-in period. 52 week double-blind treatment~     period, and 3 week follow-up period.~   "
88022|NCT02414945|"~     This is a phase I and II clinical study for patients with malignant pleural mesothelioma (a~     type of cancer affecting the lining of the lung). Patients will receive an infusion (given by~     vein) of autologous tumor infiltrating lymphocytes (TILs). TILs are a type of white blood~     cells that recognizes tumor cells and enter them which causes the tumor cells to break down.~      Prior to the cell infusion, patients will receive a two drugs cyclophosphamide and~     fludarabine to prepare the body to receive the TILs. After cell infusion, patients will~     receive low-dose interleukin-2 therapy. This study will see how safe and useful this regimen~     is in treating malignant pleural mesothelioma.~   "
88023|NCT02414932|"~     Depression affects up to 20% of people in their lifetime and can be a severe debilitating~     illness. Indeed, the World Health Organisation has estimated that depression will soon be the~     second leading contributor to the burden of disease worldwide. One of the big problems for~     patients and doctors is that currently available antidepressant drugs and psychotherapies do~     not work for 30% of people. However, about 60% of such treatment-resistant patients will~     recover fully with electroconvulsive therapy (ECT). Even though it was developed over 75~     years ago, ECT continues to be the most powerful treatment for severe, often~     life-threatening, depression. Despite that, we have recently reported that severe depression~     symptoms return (called a relapse) in nearly 40% of such responders within six months of~     completing a course of ECT. Actually, such high relapse rates are seen for all patients with~     treatment-resistant depression, irrespective of what treatment they have received. There is~     thus an urgent need for better treatments to prevent relapse and one such possibility is an~     old drug called ketamine. Ketamine blocks the activity of glutamate, one of the major~     chemical messenger systems in the brain. Because of this effect it is sometimes used as an~     anaesthetic but it can also make you feel a bit high and so is sometimes abused as a~     recreational drug. Fortunately, in small doses it is quite safe. Recently, it has been found~     that ketamine has a remarkably rapid, but brief, antidepressant effect, including reducing~     suicidal thoughts. We wish to evaluate ketamine as a way to reduce relapse rates in people~     who have just been treated successfully with ECT for severe depression. Developing such a new~     treatment, and understanding how it works, would be of tremendous benefit to persons with~     severe depression, their families, and the wider society.~   "
88024|NCT02414919|"~     To assess the proportion of women who use HERC for ≥2 years of duration~   "
88025|NCT02414906|"~     Acute kidney injury (AKI) is a frequent complication in critically ill patients admitted to~     intensive care unit (ICU) and it is associated with increased morbimortality.~      There is evidence that perioperative hemodynamic optimization decreases the incidence of AKI~     in the post operative phase in high-risk patients. We aimed to evaluate if the use of a~     goal-directed therapy to increase oxygen delivery in the early phase of acute kidney injury~     can decrease the prevalence of patients with acute renal failure.~   "
88026|NCT02414893|"~     The mechanisms that regulate appetite in the morbidly obese are multifactorial and not~     well-known. Different peripheral signals (such as ghrelin or cholecystokinin) play an~     important role in the central regulation of appetite and hunger. Postprandial ghrelin and~     cholecystokinin (CCK) response has also an effect on gastric emptying that, in turn, has an~     effect on satiety sensation.~      On the other hand, bariatric surgery is supposed to affect hunger and satiety in and also~     promotes changes in gastric emptying which are not clearly defined.~      Aim: To better understand the physiologic mechanisms involved in the regulation of hunger and~     satiety in morbidly obese individuals, especially those related with gallbladder and gastric~     emptying, as well as those related with the response of the gastrointestinal hormones~     ghrelin, CCK and glucagon-like peptide-1 (GLP-1), before and after bariatric surgery (sleeve~     gastrectomy). Methodology: Three groups of individuals will be studied and compared: group A)~     non obese healthy subjects, group B) morbidly obese subjects and group C) morbidly obese~     subjects who had had a previous sleeve gastrectomy. In all subjects a standard meal test~     after a fasting night will be administered and appetite, satiety and hormonal response~     (ghrelin, CCK, GLP-1 and insulin) during 4 hours post-ingestion assessed, as well as~     postprandial gallbladder and gastric emptying by means of ultrasonography and the paracetamol~     absorption technique.~   "
88027|NCT02414880|"~     Liver cirrhosis is a progressive disease characterized by loss of functional hepatocytes that~     substantially affects drug pharmacokinetics. Rocuronium onset time is longer and recovery~     time from it is prolonged in cirrhotic patients than in those with normal liver function.~      This randomized controlled study is designed to compare the pharmacodynamic profiles of~     sugammadex and neostigmine when used for the antagonism of moderate degree of~     rocuronium-induced neuromuscular block in cirrhotic patients undergoing liver resection and~     in patients with preoperative normal liver functions undergoing liver resection.~   "
88028|NCT02414867|"~     The purpose of the study is to determine energy expenditure and fat oxidation in 2 year old~     children.~   "
88029|NCT02414854|"~     Primary Objective:~      To evaluate the efficacy of dupilumab (SAR231893 / REGN668) in patients with persistent~     asthma.~      Secondary Objectives:~      To evaluate the safety and tolerability of dupilumab. To evaluate the effect of dupilumab in~     improving patient-reported outcomes including health-related quality of life.~      To evaluate dupilumab systemic exposure and incidence of antidrug antibodies.~   "
88031|NCT02414828|"~     This was a double-blind, randomized, placebo-controlled dose-escalation study in adults~     recently treated for pulmonary TB. The dose of AERAS-402 increased in successive dose groups.~     Enrollment into a dose group was sequential. Enrollees were stratified based on time from the~     start of TB treatment. The on-TB-treatment stratum started TB treatment between 1 and 4~     months (30 to 120 calendar days) prior to Study Day 0. The post-TB-treatment stratum~     started TB treatment at least 12 months (360 calendar days) prior to Study Day 0. Subjects~     were randomized to receive a placebo or AERAS-402 vaccine. In Dose Groups 1 and 2, subjects~     were randomized to receive a single injection of AERAS-402 or placebo. Dose Group 3 subjects~     were randomized to receive two injections on study day 0 and study day 42 of AERAS-402 or~     placebo.~   "
88032|NCT02414815|"~     Atrial fibrillation(AF) is the most common sustained arrhythmia in humans. The loss of~     rate-dependent action potential duration(APD) adaptation is one of the characteristics of~     atrial fibrillation, but detailed understanding of mechanism is limited. Thus, we propose to~     utilize the monophasic action potential recording data from human patients in three groups,~     control, paroxysmal and persistent atrial fibrillation, and apply reverse engineering method~     to quantify the extent of electrical remodeling of ionic channel parameters using a~     mathematical model of atrial cell. Our approach will be useful in developing drug targets for~     ion channels in atrial fibrillation patients.~   "
88033|NCT02414802|"~     The purpose of this study is to determine whether the novel aspiration thrombectomy device~     combined with catheter-directed thrombolysis is effective in the treatment of acute~     iliofemoral deep venous thrombosis (IF-DVT).~   "
88034|NCT02414789|"~     Test and evaluate a new diagnostic method (SRM-MS/MS: Selected Reaction Monitoring- Mass~     spectrometry) for Lyme Borreliosis on human skin biopsies. Patients included are those with~     the early skin manifestation (erythema migrans).~      This new proteomic method will be compared to the two existing method: culture of Borrelia~     and PCR detection of Borrelia (DNA detection of the bacteria).~   "
88035|NCT02414776|"~     To determine the safety and tolerability of orally administered hydroxychloroquine with~     hormonal therapy.~      To assess the response rate of hydroxychloroquine in combination with hormonal therapy.~   "
88036|NCT02414763|"~     The current study proposes to study the feasibility and acceptability of a brief psychosocial~     intervention delivered to suicide attempt survivors hospitalized on a medical/surgical floor~     or inpatient psychiatry unit at Vanderbilt University Medical Center. The proposed study will~     involve training of care providers affiliated with Vanderbilt University Medical Center to~     deliver the brief intervention. Additionally, the participants will complete baseline, 1, 3,~     and 12-month assessments on outcomes of interest, including readiness to change problematic~     behaviors, engagement in outpatient mental health services, suicidal ideation, self-harming~     behavior, and reasons for living.~   "
88037|NCT02414750|"~     This is a single arm explorative phase II clinical trial in 90 subjects with advanced stage~     melanoma harbouring a BRAFV600 mutation. PET imaging and molecular diagnostics are combined~     in order to monitor response to treatment with vemurafenib plus cobimetinib, examine~     development of resistance and correlate changes in metabolic/proliferative activity with~     extend of target inhibition.~   "
88038|NCT02414737|"~     We would like to propose that it may be possible to use a solitary dose of Elonva~     (corifollitrophin alpha) as the sole gonadotrophin (FSH) stimulant for the vast majority of~     women undergoing IVF, assuming that it is possible that coasting (withholding short acting~     rFSH) from day 8 of the stimulation until trigger/ oocyte retrieval will still result in a~     significant number of mature oocytes being produced and an acceptable pregnancy rate.~   "
88039|NCT02414724|"~     This phase I trial studies the side effects and best dose of ribociclib and gemcitabine~     hydrochloride in treating patients with solid tumors or lymphoma that have spread to other~     places in the body and usually cannot be cured or controlled with treatment. Ribociclib may~     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs~     used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the~     growth of cancer cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Giving ribociclib together with gemcitabine hydrochloride may~     work better in treating patients with solid tumors or lymphoma.~   "
88040|NCT02414711|"~     Depression has emotional consequences, social and important business. Reaching at least 7.5%~     of French aged 15 to 85 years. General Practitioners are the first professional consulted in~     terms of frequency of consultations. Indeed, in primary care, 10 to 25% of patients with~     depression that General Practitioners are often alone to support and follow. But General~     Practitioners are faced with diagnostic difficulties facing the diagnosis of depression,~     because if the patient does not engage itself, no tool is validated in France to help them in~     their diagnosis. However, standardized questionary exist that allow to overcome this~     difficulty. Questionary used in other european countries. Among them, the HSCL25 scale was~     selected by a systematic review of literature and a RAND UCLA type of consensus procedure.~     This HSCL25 scale is the most efficient for the diagnosis of depression in terms of~     efficiency tool, reproducibility and ergonomics. However, it remains necessary to confirm its~     validity in terms of the French translation and in terms of efficiency.~   "
88041|NCT02414698|"~     To compare the outcomes of percutaneous lumbar Hydrodiscectomy (HydroD) with the SpineJet~     Hydrodiscectomy System to transforaminal epidural steroid injections (TESI) in patients with~     lumbar radiculopathy due to contained disc herniation with symptoms that persist following a~     treatment course of conservative management including physical therapy and anti-inflammatory~     medication.~   "
88042|NCT02414685|"~     TIP in the 1st line treatment of GCTs patients with unfavorable decline of serum tumor~     markers after 1 cycle of the BEP regimen.TIP will be administered to the patient until~     progression, unacceptable toxicity, complete response or inability of the subject to comply~     with study requirements.~   "
88043|NCT02414672|"~     The CareSTEPS intervention fills an important service gap by providing education, skills~     training, and support to the caregivers of advanced lung cancer patients on active treatment.~     The home-based delivery format will facilitate future dissemination and outreach. By~     empowering families with the skills they need to provide care and meet the challenges of lung~     cancer, this intervention holds great promise for improving caregiver quality of life (QOL),~     patient QOL, and the quality of palliative and supportive care services offered to patients~     with advanced cancer and their families.~   "
88044|NCT02414659|"~     Umbilical cord blood (UCB) collection and storage is a rapidly advancing field in hematology~     due to UCB's use for treatment of many hematological diseases, including but not limited to,~     Fanconi anemia, thalassemia, leukaemia and metabolic storage diseases. Primarily, there are~     two ways for UCB harvesting, first in-utero collection and second ex-utero collection.~     Depending on the amount of UCB collected, in-utero harvesting practice prolongs the operative~     time of cesarean delivery and speculatively increases intraoperative blood loss. The aim of~     this study is to determine UCB collection's effect on intraoperative bleeding in women~     undergoing elective cesarean delivery.~   "
88045|NCT02414646|"~     This phase II trial studies how well trastuzumab emtansine works in treating older patients~     with human epidermal growth factor receptor 2 (HER2)-positive stage I-III breast cancer. HER2~     is a protein found on the surface of cancer cells that helps them to grow and spread.~     Trastuzumab emtansine may kill cancer cells by binding to HER2-positive on the surface of the~     tumor cells and blocking their ability grow and spread.~   "
88046|NCT02414633|"~     A special investigation (post marketing observational study (PMOS)/non-mandatory) of HUMIRA®~     will be performed for correlation between baseline and follow-up by clinical observation 24~     weeks (planned visit time; before the start of treatment, and at 4, 12, 16, and 24 weeks, 4~     data collection points) in Japanese psoriatic arthritis patients who are engaged in paid~     work.~   "
88047|NCT02414620|"~     The purpose of the research was to test the efficacy of the Dental Vibe Injection Comfort~     System. The study was conducted by faculty to have students as subjects to see if there are~     any differences in the comfort level of an ASA injection given on one side with topical~     anesthesia and lidocaine 1:100,000 with epinephrine using a standard syringe, and the other~     side uing the Dental Vibe, topical anesthesia and lidocaine 1:100,000 with epinephrine and a~     standard syringe. The Dental Vibe emits strong pulsed vibration which is transmitted via a~     silicone mouth piece to mucosal tissue. This in turn interferes with, blocks or reduces the~     perception of pain from the injection for the patient. It is stated that this phenomenon is~     achieved due to the gate theory of neuronal activity. There are also likely, distraction~     and placebo effects that contribute to the devices' efficacy.~   "
88048|NCT02414607|"~     Elderberries (Sambuci fructus) have been shown in a number of studies to have significant~     anti-inflammatory and antioxidant effects. Multiple human and animal studies have supported~     the anti-inflammatory and antioxidant effects of elderberry preparations and it has been used~     in natural medicine for hundreds of years. Studies examining factors that may decrease the~     risk of Alzheimer's disease have revealed that drinking juices with similar properties to~     elderberries is one of the most reliable way to decrease risk. As such the investigators wish~     to determine the effects of elderberry juice on cognitive decline in a group of subjects at~     high risk for Alzheimer's disease, those with mild cognitive impairment. Elderberry juice is~     a commercially available nutritional supplement and easily available to this population.~   "
88049|NCT02414594|"~     The purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of~     IONIS APO(a)-LRx (ISIS 681257) given to healthy volunteer subjects.~   "
88050|NCT02414581|"~     Clinical triple-blind randomized controlled trial to assess the use of two different~     mouthwashes to reduce the oral colonization by gramnegative bacteria in patients with~     chemotherapy~   "
88051|NCT02414568|"~     This study evaluates bendamustine in patients aged over 60 years with classical Hodgkin~     Lymphoma treated by prednisone, vinblastine and doxorubicin. 90 patients will be enrolled in~     this study.~   "
88052|NCT02414555|"~     Background Intraoperative hypotension is a common problem that significantly contributes to~     perioperative mortality and morbidity. At the moment the gold standard for perioperative~     fluid management is the so called goal-directed therapy that features fluid resuscitation~     followed if necessary catecholamines if needed for perioperative cardiocirculatory support.~      Worldwide the so called physiological sodium chlorid (0.9% NaCl) solution is the most often~     used infusate for perioperative fluid management. Despite its widespread use physiological~     saline has its major disadvantages such as the increased incidence of metabolic acidosis.~     Nevertheless catecholamines have their significant side effects as well (eg diminished renal~     perfusion, increased cardiovascular morbidity) and they therefore should be used with~     caution.~      In a prior study by group members on patients undergoing renal transplantation receiving~     either physiological saline or an acetate-buffered infusate showed a 50% decrease in~     catecholamine necessity in the acetate-buffered infusate group. The investigators therefore~     would like to evaluate the effects of the perioperative fluid choice on the necessity of~     catecholamine use.~      Aim~        -  Evaluation of the perioperative fluid choice on the necessity of catecholamines for~          cardiocirculatory support.~        -  Description of the relationship between perioperative fluid choice and minimal blood~          pressure as well as the time to catecholamine use and their dosage.~      Methods The investigators plan a prospective randomized-controlled trial of all patients~     undergoing major abdominal surgery at the Vienna General Hospital and Medical University of~     Vienna. Fluid management and catecholamine use will be based on a oesophageal Doppler -based~     treatment scheme.~   "
88053|NCT02414542|"~     Post-marketing clinical study,international, multi-centre, prospective, observational. The~     investigation will be carried out in 2 sites in Europe for a maximum total number of 160~     patients.The aim of this study is to assess clinical, radiographic and subjective outcomes~     after hip arthroplasty with a cementless metaphyseal MINIMA short stem, define the~     survivorship of the implant and identify possible risk factors that may lead to failure.~   "
88054|NCT02414529|"~     The purpose of this study is to see whether giving a Vitamin D supplement to vitamin D~     deficient obese children and adolescents will decrease the risk of getting diabetes (Disease~     in which the person has high blood sugar).~      The number of vitamin D deficiency in U.S. children and teenagers has grown dramatically over~     the past 30 years. There are some reports suggesting that vitamin D supplementation in adults~     with pre diabetes (blood glucose higher than normal) and vitamin D treatment will prevent~     diabetes.~   "
88055|NCT02414516|"~     This Phase 1a, single center, open-label, repeat dose study will evaluate the safety,~     efficacy, and Pharmacokinetics of ascending doses of OBP-801 in patients with advanced solid~     tumors.~   "
88985|NCT02402335|"~     The purpose of this study is to examine whether there are relations between different types~     of pain in groups of patients with different diagnoses of degenerative diseases of the spinal~     column and their related surgeries.~   "
88056|NCT02414503|"~     Oxytocin (OT) is a small, naturally occurring peptide currently in clinical use to stimulate~     lactation in breastfeeding women. The intranasal administration of OT has recently attracted~     attention as a potential novel treatment in several psychiatric disorders in autism. However,~     given the anatomy of the nasal cavity, the current design of nasal sprays would be expected~     to provide an inadequate delivery of medication to the areas of the nasal cavity where direct~     transport into the brain via the olfactory nerve could potentially occur. OptiNose has~     developed an intranasal delivery device that provides improved reproducibility of nasal~     delivery, improved deposition to the upper posterior regions of the nasal cavity where the~     olfactory nerve innervates the nasal cavity.~      The primary objective of this study is to identify any differences between a single dose of 8~     international units (IU) oxytocin, 24 IU oxytocin, and placebo delivered intranasally with~     the optimised OptiNose device in volunteers with Autism Spectrum Disorder. This will be~     measured in terms of performance on cognitive tests and physiological markers.~   "
88057|NCT02414490|"~     This is a prospective observational study of 30 adult CIDP patients who receive home IVIg~     infusion services from AxelaCare Health Solutions, LLC. The decision to treat with IVIg will~     be entirely at the discretion of the patient's treating physician.~   "
88058|NCT02414477|"~     The purpose of this study is to better understand how people break down a tobacco specific~     cancer-causing toxin called N'-nitrosonornicotine (NNN) that is present in smokeless tobacco~     and cigarettes. Some people are able to get rid of this chemical as a harmless agent better~     than others. Through this research, the investigators hope to develop a better understanding~     of how people process potentially harmful chemicals and identify tobacco users who are in~     danger of developing cancer. Participants will complete questionnaires regarding their health~     and smoking history. The investigators will take blood samples, saliva samples, cheek cells~     and urine to measure exposure to toxins and harmful chemicals present in smokeless tobacco.~     Participants will be given smokeless tobacco study product and be asked to use only it for~     the entire time they are in the study. The study product contains deuterated NNN. Deuterated~     NNN is just like the NNN found in commercially available smokeless tobacco products, but is~     labeled with deuterium or heavy hydrogen atoms. Deuterium is non-toxic and safe. Using~     smokeless tobacco containing deuterium allows us to follow NNN as it is broken down in the~     body.~   "
88059|NCT02414464|"~     The aim of the present study was to evaluate colorimetric changes and tooth sensitivity in~     young patients submitted to tooth bleaching with 20% and 35% hydrogen peroxide.~   "
88060|NCT02414451|"~     The purpose of this study is to explore the effects of propranolol on social interaction, and~     secondarily on language, anxiety, adaptive behaviors, and global function in high functioning~     adults and adolescents with autism in a double-blinded, placebo-controlled pilot trial.~   "
88061|NCT02414438|"~     The study uses a randomized controlled study design of pediatric neurologists and~     developmental pediatricians and front-line (primary care) pediatricians to determine if use~     of FirstStepDx PLUS and Next StepDx PLUS are associated with higher clinical quality, less~     variability in clinical practice, and lower costs from decreased resource utilization. The~     Clinical Performance and Value Vignettes (CPV) used in this study simulate a clinical~     encounter for individuals with an atypical phenotype and clinical presentation indicative of~     a possible genetic disorder. We will measure the difference in combined diagnostic and~     treatment CPV® domain score post-intervention versus baseline comparing intervention and~     control groups~   "
88062|NCT02414425|"~     Fecal incontinence is a frequent pathology which concerns 10% of the general population and~     severely alters patients quality of life. The cost of urinary and faecal incontinence has~     been estimated to be $16 billions a year. Several treatments exist depending on the aetiology~     of the faecal incontinence: medical treatments, biofeedback and sacral nerve stimulation.~     Nevertheless, these treatments are not always effective (50-70% of success) and are not~     without side effects, particularly the sacral nerve stimulation (pain, infection, electrode~     displacement..).~      The intravesical injections of botulinum toxin have been used for several years for the~     treatment of urinary incontinence with overactive bladder. Several randomized trials have~     demonstrated the efficacy of these injections in patients with neurological disorders and~     overactive bladder, as well as in idiopathic overactive bladder. The toxin injections in the~     detrusor muscle increase the compliance and the bladder capacity and delay the initial~     appearance of detrusor uninhibited contraction. Furthermore, botulinum toxin decreases the~     urinary urgency. It maybe secondary to the reduction of the amplitude of the detrusor~     uninhibited contraction as well as to a direct effect of toxin on sensory pelvic nerve~     afferents.~      The botulinum toxin should play a role on motor afferents as well as on the sensory function~     of efferent nerves.~      The hypothesis is to demonstrate a decrease of active faecal incontinence and/or urgency~     episodes with improvement in quality of life, without any major side effects, in the patients~     included in this study. Nevertheless, the benefit of toxin injections are known to be~     temporary because of nerve re-growth. If we obtain similar results for fecal incontinence, it~     would be possible to schedule one to two injections a year because of the limited~     side-effects and invasiveness of the rectal injections.~   "
88063|NCT02414412|"~     This randomized, placebo-controlled, double-blind study evaluates the efficacy and~     tolerability of Ulmus macrocarpa water extract for immunity improvement in relatively healthy~     adults. 58 subjects received 500 mg of Ulmus macrocarpa water extract per day or a placebo~     for 4 weeks.~   "
88064|NCT02414399|"~     Children hospitalized with severe illness in sub-Saharan Africa are at high risk of morbidity~     and mortality following discharge from hospital. These children represent an accessible~     high-risk population in which targeted interventions to prevent morbidity and mortality could~     have dramatic impact. A large cluster randomized trial of azithromycin delivered in a mass~     drug administration program within trachoma endemic areas in sub-Saharan Africa demonstrated~     an almost 50% mortality benefit in children 1-9 years of age in treated communities. However,~     mass drug administration of azithromycin leads to the rapid emergence of macrolide resistance~     within treated communities and is expensive. The targeted delivery of azithromycin to~     children at hospital discharge may be a novel and practical intervention to maximize benefit~     while minimizing risk of antibiotic resistance. This is a randomized, double-blind,~     placebo-controlled trial to determine the efficacy of azithromycin provided at discharge,~     compared to placebo, in reducing mortality and re-hospitalization rates in children age 1-59~     months in Kenya. The study will also investigate potential mechanisms by which azithromycin~     may reduce morbidity and mortality in this population and will assess the emergence of~     antibiotic resistance among treated individuals and their primary caregivers. A~     cost-effectiveness analysis of the intervention will also be conducted.~   "
88084|NCT02414139|"~     A phase II study to evaluate antitumor activity of oral cMET inhibitor INC280 in adult~     patients with EGFR wild-type, advanced non-small cell lung cancer (NSCLC) as measured by~     overall response rate (ORR). The study will also evaluate safety and pharmacokinetics of~     INC280.~   "
88065|NCT02414386|"~     Several studies point at a potential relationship between vitamin D deficiency and worse~     outcome in critically ill patients admitted to the intensive care unit. It is linked with the~     lack of vitamin D pleiotropic effects in the state of hypovitaminosis D. The pleiotropism of~     vitamin D is dependent on a specific feature of vitamin D receptor (VDR) namely polymorphism~     and its universal existence in the human body. Vitamin D pleiotropism is linked with cancer~     cells inhibition, a modulation of the immune system, an influence on cardiovascular system~     and neuroprotection.~      In 35-65% critically ill patients hospitalized in the intensive care unit the acute kidney~     injury (AKI) is diagnosed. Acute kidney injury increases significantly the probability of~     death. The standard therapy of a severe AKI in many intensive care units is the regional~     citrate anticoagulation continuous renal replacement therapy by means of continuous~     veno-venous hemodiafiltration (CVVHDF). The specificity of the regional citrate~     anticoagulation by means of precise ionized calcium and citrate dosing evokes questions~     regarding its influence on vitamin D and entire calcium-phosphate metabolism in the state of~     a severe AKI treated with regional citrate anticoagulation continuous renal replacement~     therapy.~      The intention of that trial is to measure vitamin D plasma levels and other parameters~     (parathormone, ionized and total calcium, magnesium, phosphate, albumin, globulin) linked~     with calcium-phosphate metabolism in the human body. We would like to assess potential~     relationships between the regional citrate anticoagulation continuous renal replacement~     therapy and these parameters.~   "
88066|NCT02414373|"~     Acute urinary retention is one of the most common complications after surgery and anesthesia.~     Micturition depends on coordinated actions between the detrusor muscle and the external~     urethral sphincter. Under the influence of epidural analgesia, patients may not feel the~     sensation of bladder filling, which can result in urinary retention and bladder~     overdistension. Overfilling of the bladder can stretch and in some cases permanently damage~     the detrusor muscle. Because epidural anesthesia can be performed at various levels of the~     spinal cord, it is possible to block only a portion of the spinal cord (segmental blockade).~     Thoracic epidural analgesia with bupivacaine significantly inhibits the detrusor muscle~     during voiding, resulting in clinically relevant post void residuals which required~     monitoring or transurethral catheterisation. This bladder muscle inhibition is comparable to~     a motor blockade. The epidural administration of ropivacaine during labour results in a~     clinically relevant reduction of motor blocks.~      The hypothesis is that thoracic epidural analgesia with the local anesthetics ropivacaine~     leads to less significant changes in bladder function than bupivacaine as a control group, in~     patients undergoing lumbotomy incision for renal surgery.~   "
88067|NCT02414360|"~     The purpose of this pilot study is to determine the feasibility of running a full-scale trial~     that compares two formats of a shortened systematic review to a full-length systematic review~     to be used in clinical decision-making.~   "
88068|NCT02414347|"~     This project will collect quantitative pilot data that will allow the characterization of~     uptake and binding of 18F-AV-1451 (also known as F 18 T807), a novel tau imaging compound, in~     individuals with and without brain tau fibrils. The primary goal is to develop tau imaging~     technique as an antecedent biomarker of cognitive decline. The investigators propose to~     obtain preliminary data that will support the possibility of detecting cognitive decline in~     its earliest stages, before the occurrence of dementia.~   "
88069|NCT02414334|"~     Rationale:~      SABR (Stereotactic ablative radiotherapy) is one of the standard treatment options besides~     surgical resection for limited lung metastases (oligometastases) from colorectal cancer. High~     efficacy in terms of local control of metastatic lesions treated has been shown.~     Nevertheless, the precise effect of SABR upon progression-free- and overall survival in these~     patients is unknown. To further evaluate and develop local treatment options in metastatic~     disease, more information is necessary regarding the impact upon - and the pattern of -~     disease progression of local treatment options such as SABR.~      Objective:~      To determine the effect upon progression free survival and upon tumorload relative to~     baseline, both at one year after randomisation of immediate SABR versus delayed SABR (a~     scan-and-personalise policy). Secondarily, patterns of progression, patient-reported symptoms~     and quality of life will be monitored.~   "
88070|NCT02414321|"~     This study aims to explore the structural and functional characteristics of the pulmonary~     vasculature in adult Fontan patients.~      Objectives:~        -  Determine the effect of pulmonary vasodilatation on indexed cardiac output during~          simulated exercise.~        -  Characterization of structural properties of small pulmonary arteries.~   "
88071|NCT02414308|"~     Erectile dysfunction is growing in prevalence all over the world and one of the most existing~     disease in old age patients There is many lines of treatment concerning the status of patient~     like psychosexual, medical, and surgical treatment But Pyronie's disease is common now among~     people especially diabetics, and the role of treatment still controversial in results We can~     start conservative treatment and then surgical treatment if fail but the outcome still not~     convinced Many patients refuse to fix penile prosthesis and to make operation like nesbite~     for probability of shortening of penis We start to use stem cell in patients have erectile~     dysfunction and Peyronie's disease The injection of stem cell will be at corpora cavernosa~     and intra dorsal penile artery under Doppler device guidance~   "
88085|NCT02414126|"~     Adult patients with heart failure (HF) have an increased work of breathing and are at~     increased risk for obstructive and/or central apnea during sleep. Noninvasive continuous~     positive airway pressure (CPAP) has proved its efficacy in decreasing the work of breathing~     and improving sleep-disordered breathing in these patients.~      The aim of the study is to analyze the work of breathing and objective and subjective sleep~     quality in children with HF and to evaluate the ability of noninvasive CPAP to decrease the~     work of breathing and improve cardiac output during wakefulness.~   "
88111|NCT02413788|"~     Inflammatory markers have been analyzed in several diseases of unknown etiology, in the~     expectation of increasing therapeutic perspectives. This possibility arises from the~     different levels of tissue injury with low-grade chronic inflammation that have been observed~     in studies in which the markers were not evaluated traditionally, and today have influenced~     clinical management.~      The investigators aimed, therefore, to evaluate the inflammatory markers in patients with AIS~     before and after aerobic and combined exercise training.~   "
89009|NCT02402023|"~     The purpose of this clinical trial is to determine the feasibility and efficacy of an~     intervention designed to increase rates of tobacco abstinence for cancer patients before~     their cancer surgery.~   "
88072|NCT02414295|"~     Klinefelter syndrome KS is caused by an additional X chromosome in males (47,XXY). Clinical~     findings are nonspecific during childhood; thus, the diagnosis commonly is made during~     adolescence or adulthood in males who have small testes with hypergonadotropic hypogonadism~     and gynecomastia. Virtually all men with Klinefelter syndrome are infertile.~      Approximately one in 1,000 boys is born with an additional X chromosome—47,XXY, the karyotype~     that causes Klinefelter syndrome. This karyotype is detected at or before birth in 10 percent~     of affected boys, and it is found during adulthood in 25 percent of affected men. Almost all~     men with a 47,XXY karyotype will be infertile; Klinefelter syndrome accounts for 3 percent of~     male infertility.~      Klinefelter syndrome is common in infertile men with oligospermia or azoospermia (5 to 10~     percent).~      Infertility in men with Klinefelter syndrome is caused by a precipitous drop in sperm count.~     If sperm are present, cryopreservation is useful for future family planning with~     intracytoplasmic sperm injection, and if not, testicular sperm extraction may be pursued.~     Although there have been multiple reports of successful fertilization by men with Klinefelter~     syndrome.~      Mesenchymal stem cell injection in testicular tubules and intra testicular artery using~     surgical microscope.~      The period for follow up last from three months to twelve months including semen analysis to~     detect sperm and hormonal profile .~   "
88073|NCT02414282|"~     This project will collect quantitative pilot data that will allow the characterization of~     uptake and binding of 18F-AV-1451 (also known as F 18 T807), a novel tau imaging compound, in~     individuals with Progressive Posterior Cortical Dysfunction (PPCD). The primary goal is to~     develop tau imaging technique as an antecedent biomarker of cognitive decline. The~     investigators propose to obtain preliminary data that will support the possibility of~     detecting cognitive decline in its earliest stages, before the occurrence of dementia.~   "
88074|NCT02414269|"~     The purpose of this Phase I study is to test the safety of different doses of specially~     prepared immune cells (called T cells) collected from blood. The Investigators want to find~     a safe dose of these modified T cells for patients who have malignant pleural disease. They~     want to find out what effects these T cells have on the patient and the cancer (MPD).~   "
88075|NCT02414256|"~     We will enroll patients submitted to breast surgery (in and outsettings) with regional~     anesthesia.~      The blinded observers, in the first 48 hours post-operative, will evaluate (telephone~     interview in outsetting) the pain intensity through the Numeric Rating Scale ( 0= no pain, 10~     = worst possible pain) thereby recording the treatment procedures in accordance with usual~     clinical practice. At the same time we will evaluate the presence of intraoperative or~     postoperative complications related to regional anesthesia, the PONV rate (post-operative~     nausea and vomiting) and the analgesic/antiemetic therapy.~   "
88076|NCT02414243|"~     This is a prospective, controlled, multi-country study to verifying the hypoallergenicity of~     the new amino acid-based formula in infants and children aged< 12 years with documented cow's~     milk protein allergy (CMPA).~   "
88077|NCT02414230|"~     The purpose of this research study is to evaluate tau distribution in the brain of subjects~     with: ALS caused by different genetic mutations, any mutation carriers (with or without~     symptoms), any non-mutation carrier, any sporadic FTD, normal controls.~   "
88078|NCT02414217|"~     The objective of this project is to test two interventions designed to improve~     diabetes-related numeracy. Numeracy is the ability to understand and use numbers. People with~     diabetes use numbers in a variety of ways in managing their condition (e.g., understanding~     blood sugar values, counting carbohydrates, taking medications at the right dose and time).~     As part of this project, the investigators developed and pilot tested two interventions to~     improve diabetes-related numeracy: (1) a series of in-person education classes and (2) a~     one-time, online diabetes education class. The investigators will look to see whether~     participants in the education classes show improvements in their diabetes-related numeracy~     skills, self-care behavior and attitudes, and clinical outcomes (i.e., body mass index, blood~     pressure, blood sugar [A1c]).~   "
88079|NCT02414204|"~     Patients with stage IV and V chronic kidney disease and end stage renal disease requiring~     hemodialysis at UAB Dialysis Clinics will be recruited from the UAB Vascular Access Clinic,~     which has been the site for recruitment of patients requiring new vascular access for the~     last 10 years.~   "
88080|NCT02414191|"~     The investigators aim to assess the impact of benchmarked and ranked feedback on~     anesthesiologists' perioperative temperature management and subsequent patient outcomes.~   "
88081|NCT02414178|"~     The purpose of this research study is to evaluate a new radioactive compound used in positron~     emission tomography (PET) scans in identifying tau tangles (a certain protein that might be~     associated with Dominantly Inherited Alzheimer's Disease) in the brain, and if the amount of~     tau tangles in the brain has a relationship to cognitive status.~      This study involves a PET scans using the radioactive compound, F 18 T807 for measurement of~     tau deposition. This radioactive compound is not approved by the United States Food and Drug~     Administration (FDA). An MRI may also be conducted.~   "
88082|NCT02414165|"~     This is a multicenter, randomized, open-label phase 2/3 study of Toca 511 and Toca FC versus~     standard of care that comprises Investigator's choice of single agent chemotherapy (lomustine~     or temozolomide) or bevacizumab administered to subjects undergoing resection for first or~     second recurrence (including this recurrence) of GBM or AA. Subjects meeting all of the~     inclusion and none of the exclusion criteria will be randomized prior to surgery in a 1:1~     ratio to receive either Toca 511 and Toca FC (Experimental arm, Arm T) or control treatment~     with one option of standard of care (Arm SOC). Stratification will be done by IDH1 mutation~     status. A second stratification factor is based on the patient's Karnofsky Performance Score~     (KPS) (70-80 vs 90-100). Further, to account for potential differences in treatment choices~     for the control arm in regions, the trial will be stratified by geographical region during~     the randomization process.~      Funding Source - FDA OOPD~   "
88083|NCT02414152|"~     The purpose of this study is to determine if anakinra (an interleukin-1 receptor antagonist)~     can improve hearing thresholds in patients with sudden sensorineural hearing loss that did~     not respond to oral steroid therapy. The patients to be enrolled will have recently completed~     a course of oral steroids and demonstrated no change in their audiometric thresholds~     following corticosteroid therapy.~      The investigators will be measuring hearing thresholds (Pure tone average and word~     recognition scores) before and after anakinra and correlating these findings with circulating~     IL-1 levels in the patient's blood.~   "
88086|NCT02414113|"~     Before considering high-GVHD Negative Outcome Score (GNOS) donor selection for routine~     clinical practice, this blinded prospective study will be carried out for assessment of~     severe GVHD (graft-versus-host-disease) reduction associated with selecting high-GNOS donors~     for allogeneic hematopoietic peripheral blood stem cell transplant. The objective of this~     prospective study is to show: (a) that GVHD reductions and donor availabilities as observed~     in the retrospective studies also apply to prospective samples that are collected and~     processed from on-going matched unrelated transplants, and (b) that high-GNOS donor selection~     readily fits into today's donor selection process, such as to facilitate access to the~     benefits of GVHD reduction. The prospective study is designed to be blinded, and will not~     involve specific donor selection nor any influence on clinical management or decision making~     by application of the GNOS technology.~      To determine if some GNOS models perform better than others across different clinical~     centers, or across different recipient / donor attributes, 4 different specific GNOS models~     will be evaluated. Bootstrap computational analyses have been carried out on the~     retrospective data for the 4 GNOS models and will be tested and validated in this prospective~     study.~   "
88087|NCT02414100|"~     This pilot research trial studies patient derived cancer cell lines in identifying molecular~     changes in patients with previously untreated pancreatic cancer and are receiving gemcitabine~     hydrochloride-based chemotherapy. Cell lines refer to samples taken from the patient's tumor~     to grow for many months or years in a laboratory, and can therefore be studied~     scientifically. Studying cell lines in the laboratory may help doctors understand the genetic~     changes that occur to the tumor during chemotherapy that allows the tumor to resist or grow~     despite treatment.~   "
88088|NCT02414087|"~     Using double blind, randomized controlled design to study the short-term therapeutic effects~     of customized arch-support shoe insoles to children with flat foot.~   "
88089|NCT02414074|"~     This pilot study conducts feasibility research to develop adaptive intervention strategies~     for conduct problems prevention. The adaptive model will stipulate for whom only brief~     prevention strategies are sufficient and for whom more intensive strategies are necessary.~     The research will involve youth (10-17 years of age) identified by law enforcement as early~     offenders and who are referred for pre-court juvenile diversion programming.~   "
88090|NCT02414061|"~     The purpose of this study is to investigate whether the addition of whey protein to a~     breakfast high in carbohydrate content will influence acute metabolic and appetite responses,~     as well as responses to a subsequent lunch meal.~   "
88091|NCT02414048|"~     The primary objective is the prospective determination of disease-specific and overall~     survival in head and neck cancer patients who have undergone surgery, correlated to~     non-invasive methods of measuring tumour hypoxia.~      The secondary objective is to define tumour hypoxia using non-invasive methodology.~   "
88092|NCT02414035|"~     The purpose of this study is to determine whether dabigatran is associated with higher risk~     of bleeding in Asia area especially in China clinical practice and whether it need to set up~     a monitor system.~   "
88093|NCT02414022|"~     The planned analysis is a prospective cost-effectiveness (cost-utility) analysis from the~     perspective of the Canadian public healthcare system, examining the costs and outcomes~     (quality-adjusted life years gained) of ibrutinib-based therapy compared to a standard~     therapy (bendamutine-rituximab). Collection and management of the data required for the~     economic analyses (including resource utilization and outcomes) will be fully integrated into~     the clinical data. Health state utilities will be derived directly from the study population.~   "
88094|NCT02414009|"~     Open-label, randomized, multicenter, Phase II trial designed to estimate the efficacy of~     CAPTEM versus FOLFIRI as second line treatment in MGMT methylated, RAS mutated advanced CRC~     patients who have progressed on or after first-line oxaliplatin containing chemotherapy for~     metastatic disease. MGMT will be assessed centrally at Pathology Department of Fondazione~     IRCCS Istituto Nazionale dei Tumori prior to enrollment. A minimum of ten 3-micron unstained~     sections on charged slides of tumor will be required and methylation status will be provided~     within a maximum of seven days to the Study Centers. Presence of RAS mutation will be~     assessed at each local participating center. Eligible patients will be randomized in a 1:1~     ratio to one of two treatment arms:~        -  Arm A (experimental arm): CAPTEM~        -  Arm B (control arm): FOLFIRI Study treatment will be given in cycles repeated every 28~          days for Arm A and every 14 days for Arm B. Patients in Arm A will receive capecitabine~          at the oral dose of 1500 mg/mq/die bid from day 1 to day 14 every 28 days plus~          temozolomide 150 mg/mq/die bid starting on day 9 to 14 every 28 days. Patients in Arm B~          will receive FOLFIRI chemotherapy starting Day 1 q2w (every cycle) starting on Day 1 of~          Cycle 1. FOLFIRI consists of irinotecan (starting dose of 180 mg/m2) on day one only;~          5-FU 7 (starting bolus and 22-hour infusional doses of 400 mg/m2 and 600 mg/m2,~          respectively), and leucovorin (racemic, starting dose of 200 mg/m2 or L-form, starting~          dose of 100 mg/m2) for two consecutive days. Treatment will continue for up to 6 cycles~          in Arm A and up to 12 cycles in Arm B or up to disease progression, unacceptable~          toxicity or informed consent withdrawal. Randomization will be stratified across the~          treatment arms by the following predefined stratification variables: disease progression~          within 9 months from the start of first-line oxaliplatin-containing chemotherapy (< vs.~          ≥9 months); prior bevacizumab in combination with oxaliplatin-based chemotherapy (yes~          vs. no). Efficacy assessments will be performed every 2 cycles in Arm A and every 4~          cycles in Arm B until progression. The study is expected to enrol approximately 82~          patients who meet the eligibility criteria.~   "
88095|NCT02413996|"~     The aim of this study is to assess the efficacy of virtual rehabilitation through the Virtual~     Reality Rehabilitation System (VRRS) versus traditional rehabilitation improving the~     functional outcomes after primary Total Knee Arthroplasty (TKA).~   "
88096|NCT02413983|"~     Living donor liver transplantation (LDLT) is an important option for patients with end-stage~     liver disease requiring liver transplantation. When performing LDLT, the safety and well~     being of donors is of the utmost importance. The conventional incision for donor hepatectomy~     is a right subcostal incision with a midline extension up to xiphoid. Minimally invasive~     liver surgery throughout a single 10 cm upper midline incision without laparoscopic~     assistance has been widely applied and considered to be safe and effective. Recently,~     laparoscopic and minimally invasive living donor hepatectomy via transverse incision has been~     suggested to reduce morbidity and the invasiveness of living donor hepatectomy. Although~     minimally invasive approach has become the surgical method of choice for many transplant~     centers, little data on comparing the impact of all three different type incision in living~     liver donors. In our center, the investigators have adopted three different incision~     according to surgical teams. The investigators undertook this study with the aims of~     comparing the pain and quality of life of donors according to type of three different~     incisions and assessing any benefits to the donor due to the smaller midline incision during~     the early postoperative period.~   "
88097|NCT02413970|"~     The purpose of this study is to obtain additional long-term safety and efficacy data on the~     use of Inspire therapy.~   "
88099|NCT02413944|"~     Study objectives: First, to determine whether intravenous injection of 1 mcg~     adrenocorticotropic hormone (ACTH) through short cannula, in healthy participants, provides~     reliable results of cortisol response, and whether this method would replace the conventional~     technique of injecting ACTH by a needle directly into a peripheral vein. Secondly, to~     determine salivary free cortisol concentration during the test in healthy controls.~      Rationale of study: Intravenous injection of synthetic ACTH1-24 concentration through venous~     short cannula appears to be feasible and simple method. On the other hand, injection of~     ACTH1-24 by a needle directly into peripheral vein, is not infrequently complicated by~     technical problems in subjects with challenging veins. The investigators suppose that, both~     methods would have the same yield in predicting cortisol response.~      Salivary free cortisol test has an evolving importance in assessing the adrenal function.~     This test would be reliable for use in low dose ACTH stimulation (1 mcg) test. The~     investigators will examine the concentration of salivary free cortisol during ACTH~     stimulation test, in order to determine level range in normal controls.~   "
88100|NCT02413931|"~     Single-center, observational, prospective cohort study including patients hospitalized on the~     multidrug-resistant tuberculosis ward at Marius Nasta Institute.~      The increasing rates of multidrug-resistant (MDR) tuberculosis (TB) are causing great~     concern. The current study that will be conducted at the Marius Nasta Institute, one of two~     nationwide excellence treatment centers for MDR-TB in Romania, is aiming to prospectively~     investigate the population structure of patients with MDR-TB admitted for treatment and the~     M. tuberculosis strains isolated from these patients. Transmission of MDR- strains of~     Mycobacterium tuberculosis among patients hospitalized there will be also ascertained.~     Additionally biomarkers for treatment response during the course of the tuberculosis therapy~     will be evaluated.~      The study will be conducted in a co-operation between the Marius Nasta Institute and the~     German Center for Infection Research (DZIF).~   "
88101|NCT02413918|"~     1. To assess the acute and long-term bimodal efficacy of iloperidone (IL), as an adjunct to~          ongoing treatment with lithium (Li) or divalproex (DIV) or lamotrigine (LAM) or any~          combination of the three thereof, in a group of patients with an index episode of a~          mixed state in BD.~        2. To assess background, baseline features, and behavioral components which characterize~          treatment response/non-response in the acute and long term management of MS~   "
88102|NCT02413905|"~     The investigators performed two case-control studies in Niger and Senegal analysing fecal~     microbiota to characterize the specificity of the gut microbiota alteration associated with~     severe acute malnutrition (SAM).~   "
88103|NCT02413892|"~     Echinocandins are the drug of choice in severe candida infections. Efficacy of echinocandins~     is related to concentration and area under the curve (AUC) of the drug.~      Available pharmacokinetic studies found that concentration of echinocandins mainly~     caspofungin is sub-optimal in severe candida infections in intensive care unit (ICU)~     patients.~      Higher dose of caspofungin has been proven to be safe in critically ill patients but its~     impact on the ability to reach PK/PD target is unknown.~      The aim of this study is to evaluate the impact of a loading dose of caspofungin on PK/PD~     parameters within the first 24-hours.~   "
88104|NCT02413879|"~     This study entitled, An Evaluation of the Safety and Efficacy of the CleanCision Wound~     Retraction and Protection System in Protecting Surgical Incisions from Intraoperative~     Contamination When Used during Colorectal Surgery, is designed to evaluate contamination at~     the wound incision site when the CleanCision is used during surgery.~   "
88105|NCT02413866|"~     The purpose of this study is to examine whether chronic moderate sleep restriction effects~     the amount of body fat and lean mass loss, and calorie expenditure, in individuals who are~     participating in a dietary weight loss program.~   "
88106|NCT02413853|"~     This randomized phase II trial studies how well combination chemotherapy and bevacizumab with~     or without CBP/beta-catenin antagonist PRI-724 (PRI-724) works in treating patients with~     newly diagnosed colorectal cancer that has spread to other places in the body. Drugs used in~     chemotherapy, such as leucovorin calcium, oxaliplatin, and fluorouracil, work in different~     ways to stop the growth of tumor cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may~     block tumor growth in different ways by targeting certain cells. PRI-724 may help stop the~     growth of cancer cells by blocking the specific signaling pathway that cancer cells need to~     grow and spread. It is not yet known whether combination chemotherapy and bevacizumab works~     better with or without PRI-724 in treating patients with metastatic colorectal cancer.~   "
88107|NCT02413840|"~     This study expect to investigate psychological intervention (Baduanjin qigong) in COPD~     patients combined with anxiety and/or depression.~   "
88108|NCT02413827|"~     This is a study to determine the clinical benefit (how well the drug works), safety and~     tolerability of combining a) varlilumab and ipilimumab and b) varlilumab, ipilimumab,~     CDX-1401 and poly-ICLC. The study will enroll patients with unresectable Stage III or Stage~     IV melanoma.~   "
88109|NCT02413814|"~     Problematic anger is a strong predictor of failed attempts at smoking cessation. The~     investigators proposed study seeks to evaluate whether a novel 8-session computerized~     anger-reduction treatment improves quit rates among smokers. Smokers with elevated trait~     anger will be administered transdermal nicotine patch therapy and either anger-reduction~     treatment or a control intervention. They will be assessed throughout treatment and up until~     three months after a scheduled mid- treatment quit date. The investigators propose to test~     whether, compared to the control condition, the anger-reduction treatment will lead to: 1)~     greater reductions in anger and 2) greater abstinence rates at post-cessation and at~     follow-up assessments. The investigators will also test whether changes in anger-related~     symptoms account for group differences in abstinence rates.~   "
88110|NCT02413801|"~     The events that underlie the conversion from Psoriasis to Psoriatic Arthritis (PsA) are not~     well understood. This conversion occurs 30% of the time within the first 10 years of~     psoriasis diagnosis. PsA patients have about a 50% chance of developing joint damage within~     the first 2 years of disease. A biomarker that identifies subclinical joint inflammation in~     psoriasis patients would allow for a diagnostic tool to allow for earlier intervention in~     psoriasis patients and provide a better understanding of the underlying molecular~     pathogenesis that may lead to development of new therapeutic targets in PsA.~   "
88112|NCT02413775|"~     One goal of the investigators of the Department of Anesthesiology and Intensive Care Medicine~     CVK/CCM, Charité - University Medicine Berlin is a continuous improvement in the quality of~     care to the patients. One focus is the freezing preoperatively during surgery, and on the~     follow-up study to assess the perceived waiting times in the anesthesiology outpatient~     clinic.~      The project aims to quality assurance and quality improvement of the Department of~     Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine Berlin .~   "
88113|NCT02413762|"~     This study aims to investigate the potential of the gut hormones GLP-1, PP, PYY and the iron~     regulatory hormone hepcidin as biomarkers for progression to complications in diabetes~     mellitus.~   "
88114|NCT02413749|"~     Biologics such as anti-Tumor Necrosis Factor or TNF inhibitor (TNFi) for treatment of~     Psoriatic Arthritis (PsA) has greatly reduced bone damage. This collaborative study will~     provide insights into key mechanisms that underlie inflammatory arthritis and bone damage in~     psoriatic joints and will catalyze biomarker discovery, identifying early biologic responders~     to facilitate optimization of therapy.~   "
88115|NCT02413736|"~     In this study, patients who have been diagnosed with gastrointestinal stromal tumor (GIST)~     and have been treated with adjuvant imatinib for 3 years after surgery will be randomly~     allocated in a 1:1 ratio to receive imatinib (Gleevec) for 2 more years (Arm A) or to stop~     imatinib (Arm B). The study participants are required to have histologically verified GIST~     with a high risk of GIST recurrence despite removal of all macroscopic GIST tissue at surgery~     and 3 years of adjuvant imatinib. The high risk of GIST recurrence is defined as one of the~     following: gastric GIST with mitotic count >10/50 high power fields (HPFs) of the microscope,~     non-gastric GIST with mitotic count >5/50 HPFs, or tumor rupture. Study participants~     allocated to Arm A will receive imatinib 400 mg/day for 24 months after the date of~     randomization. All study participants will be followed up using blood tests and computerized~     tomography (or MRI) of the abdomen. The computerized tomography examinations will be~     performed at 6 month intervals. A total of 300 patients will be entered to the study. The~     study hypothesis is that adjuvant imatinib given for a total of 5 years may prevent some of~     the GISTs to recur as compared to patients who receive adjuvant imatinib for 3 years, and~     there may be a difference in the rate of GIST recurrence between the two groups.~   "
88116|NCT02413723|"~     The aim of this study is to demonstrate that the rate of successful orotracheal intubation at~     first laryngoscopy will be higher in patients intubated with McGrath Mac videolaryngoscope~     compared to patients intubated with classical Macintosh laryngoscope in patients requiring an~     orotracheal intubation in ICU.~   "
88117|NCT02413710|"~     The aim of this clinical trial is to assess the effects of daily consumption of soy protein~     foods on body composition, general health status and dietary intake outcomes in generally~     healthy children.~   "
88118|NCT02413697|"~     Objectives: To assess whether embryo transfer guided by three-dimensional ultrasound (3DUS)~     produces a significantly higher clinical pregnancy rate than embryo transfer guided by~     two-dimensional ultrasound (2DUS).~      Hypothesis: 3DUS guided embryo transfer will produce a significantly higher clinical~     pregnancy rate compared with 2DUS guided embryo transfer. Design and subjects: Prospective~     randomised control trial (RCT) at the Prince of Wales Hospital. Inclusion criteria include~     women undergoing embryo transfer in fresh and frozen cycles. Exclusion criteria include women~     aged >42 years and women whose endometrial cavity cannot be visualised adequately via US.~     Power calculations indicate that 232 patients per arm are required to demonstrate an increase~     of 12% in clinical pregnancy rates.~      Study instruments: US examinations will be performed using a General Electric(GE) Voluson~     series US machine with a standard 3D transvaginal probe. For embryo transfer, the Cooks~     Guardia Access EchoTip catheter will be used.~      Interventions: 3D versus 2DUS for guidance during embryo transfer. Main outcome measures:~     clinical pregnancy. Secondary outcome measures: implantation rate, multiple pregnancy,~     miscarriage, ectopic pregnancy and live birth rates.~      Data analysis: Data processing and analysis will be performed using the Statistical Packages~     of Social Sciences for Windows (SPSS, Inc). Descriptive and comparative statistical methods~     will be used to analyse the primary outcomes. P-values of <0.05 will be considered~     significant.~      Expected results: The study arm undergoing 3DUS guided embryo transfer are expected to have~     an improved clinical pregnancy rate compared with the control arm undergoing 2DUS guided~     embryo transfer.~   "
88119|NCT02413684|"~     The purpose of this study is to test the impact of an innovative patient engagement solution~     on patient's quality of life and asthma-related outcomes, and evaluate the correlation~     between a patient reported outcome measure and clinical outcomes.~   "
88120|NCT02413671|"~     The study compared the acute effects of the supplementation of a standardized meal with~     either lupin or whey protein or no protein on the whole-body glucose and insuline metabolism.~   "
88121|NCT02413658|"~     The purpose of this study is to investigate the potential healing properties of phenytoin.~      The investigators will use the donor site of a split skin thickness graft (SSTG) to model a~     basic wound in a randomized controlled trial of topical phenytoin against current best~     clinical practice. The investigators aim to demonstrate a dose dependent effect. The~     investigators hypothesis, based on previous clinical experience at our center and on current~     available literature, that phenytoin will reduce wound healing time.~   "
88122|NCT02413645|"~     The mai purpose of the study is to evaluate the safety and to establish the recommended dose~     of iHIVARNA-01 as a new therapeutic vaccine against HIV~   "
88123|NCT02413632|"~     Comparison of two screening strategies of asymptomatic sexually transmitted infections :~     routine screening versus screening as reported by the risks taken by the patient, in a cohort~     of HIV outpatients men who have sex with men. The aim of this study will be create and~     validate a simple tool for clinicians. A digital tool will be developed will allowed~     empowerment of HIV-positive men who have sex with men.~   "
88154|NCT02413229|"~     The objectives of this study are to evaluate the therapeutic efficacy and safety of DSXS and~     a Placebo in patients with moderate to severe scalp psoriasis.~   "
88183|NCT02412852|"~     In this study, subjects with diabetic neuropathic pain (DNP) will be treated for 12 weeks~     with either placebo, 40 or 80 mg sustained release sodium nitrite (TV1001sr) twice daily.~     Primary endpoints will be safety and pharmacokinetics. Assessment of the study medications~     affects on pain following treatment will also be recorded.~   "
88124|NCT02413619|"~     Epiretinal membrane is treated with vitrectomy and peeling. Afterwards cataract is usually~     developed, which requires a cataract surgery.~      The aim of this study is to investigate the refractive consequences of surgery for Epiretinal~     membrane and cataract.~      Investigators investigate the sequence of surgery in patients having surgery for Epiretinal~     membrane and cataract in a prospective clinically randomized intervention trial. Patients are~     randomized to 1) start with vitrectomy, 2) start with cataract surgery, 3) combined surgery.~     Investigators want to find the sequence of surgery that gives the most optimal refractive~     result, the most stabile intraocular lens, and the minimal loss of corneal endothelial cells.~   "
88125|NCT02413606|"~     Background: It has often been hypothesized that the frequency of follow-up for patients with~     early-stage endometrial cancer could be decreased. However, studies evaluating effects of a~     reduced follow-up schedule among this patient group are lacking.~      Objective: Assess patient satisfaction and cost-effectiveness of a less frequent follow-up~     schedule compared to the schedule according to the Dutch guideline.~      Study design: Dutch multicentre randomized controlled trial with a 5 year follow-up. Patients~     (n=282) are randomized in an intervention group with 4 follow-up visits during 3 years, and a~     control group with 10-13 follow-up visits during 5 years, according to the Dutch guideline.~     Patients are asked to fill out a questionnaire at baseline, 6, 12, 36 and 60 months. Patient~     inclusion will take two years (if 60% of the patients participate).~      Outcomes: Primary: Patient satisfaction with follow-up care and cost-effectiveness.~      Secondary: health care use, adherence to schedule, health-related quality of life, fear of~     recurrence, anxiety and depression, information provision, recurrence, survival~      Patients: Stage 1A and 1B low-risk endometrial cancer patients, for whom adjuvant~     radiotherapy is not indicated~      Statistics: linear regression analyses to assess differences in patient satisfaction with~     follow-up care between intervention and control group adjusted for potential pre-defined~     confounders.~      Expected results: Patients in the intervention arm have a similar satisfaction with follow-up~     care and overall outcomes, but lower health care use and costs than patients in the control~     arm. No effects are expected on QALY differences (losses) and satisfaction, but the reduced~     schedule is expected to save 144.000 per year in the Netherlands.~   "
88126|NCT02413593|"~     This study will evaluate the antiviral efficacy, safety, and tolerability of~     ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) plus ribavirin (RBV) in~     treatment-naive adults with chronic genotype 3 hepatitis C virus (HCV) infection.~   "
88127|NCT02413580|"~     This is a multicenter, prospective, open-label, non-controlled study to assess the efficacy~     and safety of an IV dose of 2 g/kg of IGIV-C in subjects with MG exacerbations.~   "
88128|NCT02413567|"~     The purpose of this study is to evaluate the Fractyl Duodenal Mucosal Resurfacing (DMR)~     Procedure for the treatment of Type 2 Diabetes.~   "
88129|NCT02413554|"~     Delirium is a common and serious condition and is associated with adverse outcome. The~     elderly who have cognitive dysfunction are expected to show delirium more frequently. It is~     most likely that delirium represents a response to impaired cholinergic neurotransmission.~     Investigators aimed to establish the preventive effect of the cholinesterase inhibitor,~     rivastigmine patch, on the post-operative delirium limited to femur neck fracture operation~     in patients at risk of dementia.~   "
88130|NCT02413541|"~     This research project is a study to immunology changes in critically ill patients with severe~     sepsis by using Endotoxin Activity Assay (EAA) combined with Polymyxin-B Hemoperfusion.~   "
88131|NCT02413528|"~     The purpose of this study is to assess the use of a mobile health intervention to improve~     adherence to asthma medication among adolescents. The intervention consists of an inhaler~     sensor strap to monitor asthma inhaler use and a mobile phone application to remind and~     incentivize patients to use their medication. This study will assess medication use~     throughout the study in patients who receive a mobile app with reminders and asthma control~     as measured by the ACT [asthma control test].~   "
88132|NCT02413515|"~     To evaluate antihypertensive efficacy and tolerability of Nifedipine GITS 60mg treated for 8~     weeks in Chinese hypertensive subjects who failed to achieve BP control with the~     starting-dose antihypertensive monotherapy.~   "
88133|NCT02413502|"~     The objective of this protocol is to obtain biological samples through leukapheresis and~     cryopreservation of cells for the future study, by in vitro assay, of immune responses after~     one dose of BCG in BCG-naïve healthy adults.~   "
88134|NCT02413489|"~     The purpose of this study is to assess overall response rate [ORR, including complete~     response (CR) and partial response (PR)], of daratumumab in participants with non-Hodgkin's~     lymphoma [a cancer of the lymph nodes (or tissues)-NHL] and to evaluate association between~     ORR and CD38 expression level in order to determine a threshold for CD38 expression level in~     each NHL subtype, above which daratumumab activity is enhanced in participants with relapsed~     or refractory mantle cell lymphoma, diffuse large B-cell lymphoma, and follicular lymphoma.~   "
88135|NCT02413476|"~     The study aims to compare the clinical outcomes between robotic-assisted and~     laparoscopic-assisted gastrectomy for gastric cancer,and evaluate the the feasibility and~     safety of robotic gastrectomy. Furthermore, the investigators can explore the patients who~     are more suitable for robotic gastrectomy.~   "
88136|NCT02413463|"~     Prospective randomized interventional comparative study~   "
88137|NCT02413450|"~     Human induced pluripotent stem cells (hiPSCs) have driven a paradigm shift in the modeling of~     human disease; the ability to reprogram patient-specific cells holds the promise of an~     enhanced understanding of disease mechanisms and phenotypic variability, with applications in~     personalized predictive pharmacology/toxicology, cell therapy and regenerative medicine. This~     research will collect blood or skin biopsies from patients and healthy controls for the~     purpose of generating cell and tissue models of Mendelian heritable forms of heart disease~     focusing on cardiomyopathies, channelopathies and neuromuscular diseases. Cardiomyocytes~     derived from hiPSCs will provide a ready source of disease specific cells to study~     pathogenesis and therapeutics.~   "
88138|NCT02413437|"~     The purpose of this study is to estimate the clinical value of contrast-enhanced ultrasound~     in percutaneous biopsy for liver occupied lesion.~   "
88139|NCT02413424|"~     The purpose of this research study is to examine whether sugar-replacement sweeteners that~     are currently on the market (ex. Sucralose, which is in Splenda) change how well the body~     works to control blood sugar.~   "
88140|NCT02413411|"~     A randomized, controlled design will be utilized to examine and compare the effectiveness of~     the proposed educational intervention, which includes a combination of an educational~     decision aid and motivational interviewing with attention control on select key~     patient-centered and process of care outcomes. The study sample will consist of approximately~     450 African-American patients with osteoarthritis of the knee. Patients will be recruited~     from the University of Pennsylvania Health System and the Philadelphia VA Medical Center and~     will be randomized to one of the two study arms.~      The immediate goal of this randomized controlled trial is to assess the effect of a~     high-quality, evidence-based, patient-centered educational intervention supplemented with~     targeted counseling (motivational interviewing) on African American patient preferences,~     expectations, and the likelihood of achieving a referral for surgical evaluation. The~     long-term goal of this research is to widely implement a patient-centered educational~     intervention targeting African Americans who are potential candidates for joint replacement,~     in a national effort to reduce and ultimately eliminate racial disparities in the utilization~     of this effective treatment option.~      Study Aim:To examine the effect of the knee osteoarthritis Decision Aid (DA)/Motivational~     Interviewing (MI) intervention on orthopedic surgery referral rates for African American (AA)~     patients. Hypothesis: Compared to attention control, the DA/MI intervention will lead to~     higher orthopedic surgery referral rates for AA patients.~      Secondary aim: To examine the effect of the DA/MI intervention on the rate of knee~     replacement receipt among AA patients. Hypothesis: AA patients randomized to receive the~     intervention will have higher rates of knee replacement compared to those in the attention~     control group.~   "
88141|NCT02413398|"~     The purpose of this clinical research study is to determine whether dapagliflozin can improve~     (decrease) blood glucose values in patients with Type 2 diabetes and moderate renal~     impairment.This study will be conducted at approximately 100 centres from countries across~     North America and European regions. It is planned to randomize a total of 302 patients.~   "
88142|NCT02413385|"~     The HealtheSteps™ (HeS) Program is an evidence-based, community-focused, lifestyle~     prescription (Rx) program, supported by in-person coaching and innovative health~     technologies. The program improves the health of Canadians and reduces their risk for chronic~     disease by tackling three major risk factors that are shared across a number of chronic~     diseases: physical inactivity, sedentary behaviour and poor diet. Each HeS participant~     receives an individualized healthy living Rx for exercise, physical activity (step counts)~     and healthy eating, supported by coaching and technology tools to promote long-term health~     behaviour change. For this study, the investigators will undertake a 6-month pilot pragmatic~     randomized controlled trial (RCT), conducted within 5 clinic settings in Southwestern~     Ontario. The primary aim is to conduct an outcome evaluation to determine the effectiveness~     of the HeS program in helping at-risk individuals increase physical activity levels, improve~     eating habits, and improve other health behaviours and health indicators.~   "
88143|NCT02413372|"~     The purpose of this study is to determine whether BMS-986036 is effective in the treatment of~     subjects with Non-alcoholic Steatohepatitis (NASH).~   "
88144|NCT02413359|"~     The patients with complications of COPD and asthma have features mixed with two diseases,~     COPD and asthma. Therefore, the outcomes are worsened if the patients with COPD have symptoms~     overlapped with asthma, however, no sufficient data exist in Japan for estimating the~     prevalence of ACOS in patients with COPD. The primary objective of this NIS is to clarify the~     proportion of ACOS defined by GINA and GOLD in patients with COPD. The main secondary~     objectives are To explore the features of history of COPD exacerbations, symptoms,~     eosinophilic inflammation and patient background in patients with ACOS, to clarify the~     history of COPD exacerbations in patients with COPD, to evaluate the degrees of eosinophilic~     inflammation of the respiratory tract in patients with COPD and to evaluate the symptoms in~     patients with COPD. This is a cross-sectional study targeting COPD patients receiving~     outpatient treatment and follow-up by physicians in Japan. FSI is scheduled as 2Q 2015 and~     DBL would be locked by 3Q 2015.~   "
88145|NCT02413346|"~     Open-label study will evaluate the safety of an approximate 1.5 mg/kg/day dose of oral~     sarecycline in the long-term treatment of participants with moderate to severe facial acne~     vulgaris.~   "
88146|NCT02413333|"~     The purpose of this study is to evaluate Clear Care® Plus compared to PeroxiClear™ for mean~     residual peroxide in used lens cases collected at Day 30 after neutralization at recommended~     storage time.~   "
88147|NCT02413320|"~     Evaluate if the two carboplatin containing chemotherapy regimens will reduce the growth of~     breast cancer cells in women with Stage I, II, or III triple negative breast cancer.~   "
88148|NCT02413307|"~     **PLEASE NOTE** this study is currently open only to clients on the waiting list at the~     Centre for Trauma Resilience and Growth, UK.~      The project will involve adapting and implementing a five minute daily self-practice~     compassion-focused intervention and evaluate its impact on psychological and physiological~     factors associated with trauma. It aims to offer a novel intervention which may facilitate~     further benefits from trauma specific therapy. This would be a unique use of self-practice~     Compassion Focused Therapy (CFT) specifically for trauma clients. Previous research has found~     that many factors can impact on client's benefitting from therapy, including depression,~     anxiety and self-criticism. These things also get in the way of being compassionate towards~     oneself, and this can be a difficulty for people who have experienced traumatic events.~     Service users have identified that additional support before trauma specific therapy can be~     useful and this may offer a positive use of time whilst on therapy waiting lists.~      Hypotheses:~      i. A brief CFT intervention will decrease levels of depression, anxiety, stress and increase~     baseline Heart Rate Variability.~      ii. The compassion focused intervention will increase experiences of self-compassion, social~     safeness, and reduce levels of self-criticism.~      iii. High 'fear of compassion' will moderate the impact of the intervention and result in~     smaller changes in depression, anxiety, stress and post traumatic change.~      Clients of the Centre for trauma, resilience and growth will be approached to participate in~     the study. All participants will have experienced trauma for which they are seeking~     psychological support. The current compassion focused intervention will be offered to~     participants on the waiting list for trauma specific therapy at the trauma centre. Each~     participant will be asked to practice the intervention in their own time over a period of~     three weeks. There will be initial assessments, repeated assessments following the~     intervention, and repeated assessments pre and post trauma specific therapies engaged in.~   "
88149|NCT02413294|"~     The investigators are aiming to examine the acceptability and feasibility of a portable~     bright light therapy instrument to improve sleep disturbance in a preventive intervention for~     depression. The investigators will conduct an intervention that trials the use of bright~     light glasses called re-timers as a preventive intervention in older adults with sleep~     disturbance and subsyndromal symptoms of depression.~   "
88150|NCT02413281|"~     This study will evaluate the abuse potential of ALKS 5461.~   "
88151|NCT02413268|"~     A randomized comparison of topical nitroglycerin versus placebo gel for prevention of radial~     artery occlusion after transradial catheterization.~   "
88152|NCT02413255|"~     The purpose of this study is to characterize the safety, tolerability, and pharmacokinetics~     of ascending single- and multiple-doses of TAK-020 in healthy participants.~   "
88153|NCT02413242|"~     Intensive Care Unit (ICU) acquired pneumonia, including ventilator-associated pneumonia, is a~     frequently occurring health-care associated infection, which causes considerable morbidity,~     mortality and health care costs. Important pathogens causing ICU pneumonia are Staphylococcus~     aureus and Pseudomonas aeruginosa. The epidemiology of ICU pneumonia and patient-related and~     contextual factors is not fully described, but is urgently needed to support the development~     of effective interventions.~   "
88155|NCT02413216|"~     Tic Disorders (including Tourette Disorder) are relatively common in school-age children and~     for some children can lead to significant psychosocial and physical impairment and diminished~     quality of life. Non-pharmacological treatments have been shown to be effective for reducing~     tics in some children. These treatment options are desired by parents, but are not widely~     available. The investigators recently developed an online, computerized, self-administered~     version of CBIT called TicHelper.com. The current study will test the efficacy of~     TicHelper.com in a randomized clinical trial.~   "
88156|NCT02413203|"~     Cardiovascular complications of NSAIDs, selective for inhibition of COX-2, stimulated~     interest in microsomal prostaglandin E synthase-1 (mPGES-1) as an alternative drug target.~     Global deletion of mPGES-1 in mice suppresses prostaglandin (PG) E2 and augments PGI2 by PGH2~     substrate rediversion. Unlike COX-2 inhibition or gene deletion, mPGES-1 deletion does not~     cause a predisposition to thrombogenesis and hypertension. However, cell-specific deletion of~     mPGES-1 reveals that the predominant substrate rediversion product among the prostaglandins~     varies by cell type, complicating drug development. The research team has developed an ultra~     performance liquid chromatography/ tandem mass spectrometry (UPLC-MS/MS) technique that~     allows the quantification of a wide range of lipids beyond the prostaglandin pathway~     (leukotrienes, anandamide and the 2-arachidonylglycerol cascades).~      This study is designed to examine different pathway interventions from the arachidonic acid~     cascade by anti-inflammatory compounds (with a focus on mPGES-1 inhibition) in whole human~     blood in vitro (Part A) and ex vivo (Part B). In Part B, healthy volunteers will be asked to~     take a single, therapeutic dose of celecoxib and blood and urine samples will be collected~     before and after drug administration. Collected blood will be stimulated ex vivo, and lipids~     and their metabolites will be measured in blood and urine, respectively. The investigators~     expect that lipid profile from ex vivo hWBA done on celecoxib-treated subjects will~     recapitulate findings from the in vitro hWBA received with celecoxib-treated human blood~     (Part A).~   "
88157|NCT02413190|"~     This is a cross-sectional single visit study to determine bone health in individuals with~     FSHD.~   "
88158|NCT02413177|"~     The overall goal of the proposed study is to develop and test real time neurofeedback~     (EEG-RTNF) as a tool to augment Mindfulness Based Stress Reduction (MBSR). This study is~     based on the theoretical model that (1) mind-wandering and self-referential processing are~     associated with stress, (2) meditation redirects the wandering mind toward present-centered~     awareness, (3) meditation also decreases activity in hubs of the default mode network (DMN)~     involved in mind-wandering and self-referential processing, and thus (4) meditation leading~     to decreased activity in these hubs should lead to reduced stress and improved health and~     well-being. Milestones include: (1) test whether EEG-RTNF from the PCC during meditation~     augments MBSR in novices; and (2) test whether MBSR with EEG-RTNF from the PCC leads to~     real-world outcomes in reduced stress and improved attention.~   "
88159|NCT02413164|"~     The aim of the investigators' study would evaluate the effectiveness of a multimodal exercise~     program on physical fitness, physical activity level and clinical symptomatology in patients~     with schizophrenia.~      DESIGN: Randomized controlled trial. SUBJECTS OF THE STUDY: People with schizophrenia who~     receiving treatment in Regional Hospital of Malaga. INTERVENTION: DATA ANALYSIS: descriptive~     statistics, measuring central tendency and dispersion of the variables study. Inferential~     statistics will be made between intervention of key variables and outcome.~   "
88160|NCT02413151|"~     Cardiac resynchronization therapy(CRT) is recommended to reduce mortality and morbidity in~     chronic heart failure(CHF) patients New York Heart Association(NYHA) class III-IV who are~     symptomatic despite optimal medical therapy, with a reduced left ventricular(LV) ejection~     fraction(LVEF) and prolonged complex QRS. CRT improves the prognosis however, despite the~     improvement, all major trials have demonstrated that one third of the patients are~     non-responders to CRT. Three months after the CRT implant, the responders have a significant~     increase in endothelial function(EntF), a decrease in the LV end-systolic volume, and~     increase in LVEF, 6 minute walk test(6MWT), improvements in NYHA class and quality of life.~     It is currently unknown if adding an exercise training(ExT) program following CRT provides~     better clinical outcomes than CRT alone. Prior studies on CRT and ExT have been preliminary~     in nature, but suggest small improvements in functional capacity(FC). The correction of~     endothelial dysfunction is associated with a significant improvement in exercise capacity~     evidenced by a 26%increase in peak oxygen uptake. These findings are important because CHF~     patients with the greatest sympathetic activation and the most reduced EntF have the poorest~     prognosis. Our experience with coronary artery disease patients, and most recently data in~     patients with CHF show that an ExT program that combines aerobic exercise(AE) and resistance~     exercise training are more effective than an AE program alone, and the aerobic interval~     training showed better improvements than continuous endurance training. It is unknown how CHF~     with more severe functional limitations responds to ExT and, more important, the explanation~     of the physiological mechanism that can explain the improvements as a consequence of ExT.~     This lack of scientific information is urgent since this is the group of patients that~     normally is targeted for CRT. The investigators propose to use a stratified randomized~     longitudinal study to determine the additional effects of a 6 month ExT in addition to CRT in~     NYHA stage III-IV HF patients. The aims of the study are:1-to determine whether a long-term~     ExT program follow the CRT provides better clinical outcomes than CRT alone and 2-To identify~     the mechanisms of the hypothesize improvement. The results of this project will represent an~     important contribution by understanding the role of ExT after CRT NYHA stage III-IV heart~     failure(HF) patients, an understudied population with poor clinical outcome. Understanding~     the potential mechanisms associated with clinical improvement and outcome is essential for~     the rehabilitative process to develop new innovative therapies in this high risk population.~     The investigators will use state-of-art methods including an integrated assessment autonomic~     nervous system(ANS) and arterial function using 123I-MIBG scintigraphy.~   "
88161|NCT02413138|"~     The trial will consist of three stages: 1) a 30 day Phase 2 PK and PD evaluation of~     somavaratan, 2) an optional Phase 2 Extension and 3) a 12 month Phase 3 safety and efficacy~     stage. Upon completion of the PK/PD stage, the PK/PD profiles for the GHD children in this~     study will be compared to the PK/PD profiles for the GHD children treated in the Western~     study Phase 1b/2a study (Protocol 12VR2) and identify the somavaratan dose to be used in the~     Phase 3 stage in Japan. The Phase 3 stage will continue dosing for 12 months to obtain safety~     and efficacy data on 48 subjects.~   "
88162|NCT02413125|"~     Rhinosinusitis is one of the most prevalent diseases within the United States and leads to~     decreased quality of life for patients suffering from this condition. A foundation in~     treatment for rhinosinusitis is nasal saline irrigations, which are administered through an~     irrigation bottle. The irrigation bottles are prone to contamination by bacterial and fungal~     species despite proper maintenance.~      A new commercially available irrigation solution has been created using chitosan, a natural~     polysaccharide with antibacterial and antifungal properties. This research project will~     examine the ability of chitosan to decrease or prevent contamination of irrigation bottles~     after 1 month use by adult patients with rhinosinusitis.~      Participants in this project will use either saline or chitosan irrigation solution for 1~     month and then switch to the other solution for 1 month. Following 1 month of use, the~     irrigation bottles will be cultured to determine if chitosan irrigation solution decreased~     the contamination of the irrigation bottles.~   "
88163|NCT02413112|"~     It is well accepted that physical activity in the form of resistance training produces a wide~     variety of neuromuscular-skeletal and health benefits. It is recommended in Finland that~     older individuals (over 65yr) should perform resistance training twice per week.~      Unfortunately, only approx. 5% of older individuals fulfill this recommendation. As Finnish~     society grows ever older, research should focus on the specific needs of this group and how~     to improve participation in physical activity, which may ultimately lead to modification of~     physical activity recommendations - resistance training recommendations are currently the~     same for young and older adults and do not include specific recommendations on the type of~     resistance training. However, these recommendations appear to have been developed for best~     possible improvements in maximum strength and muscle size.~      Therefore, it is of great importance to identify the number of resistance training sessions~     per week required to induce improvements in physical fitness, metabolic and bone health~     status, and importantly the reasons for adherence to/drop-out of resistance training~     interventions (e.g. motivation to train) in a multi-discipline study. This knowledge would~     benefit policy makers to update current recommendations for resistance training and to devise~     strategies to advise realistic targets for resistance training in the older, particularly the~     less-educated, age group (e.g. TELI-strategy for 2020).~      The present study will include a 12-month resistance training intervention with a 12-month~     follow-up period. Interviews and questionnaires will assess psychological/sociological data~     and will be collected from both drop-out subjects and those that complete the intervention.~     Neuromuscular performance and functional capacity will be tested using conventional methods,~     along with body composition, bone density, and blood tests for metabolic markers of health.~     Diet and other physical activity will be controlled throughout the intervention period.~     Measurements are to be performed every 3 months.~      It is expected that 5 international peer-reviewed articles will be published in 2016-2017.~     The data will be presented at international and national conferences in 2015-2017. Finally,~     results of the entire research will be published in national peer-reviewed journals (e.g. The~     Age Institute's Raportteja). All subjects will be invited to attend an information meeting~     where group results will be presented and explained.~   "
88164|NCT02413099|"~     Background: KBMSI-2, which is the herbal formular consisted of Ginseng Radix Rubra, Dioscorea~     tenuipes, Cornus officinalis Sieb. Et Zucc, Lycium Chinese Mill, Curcuma logna Linn, Honey,~     improved the erectile function by preserving the smooth muscle content and inhibiting the~     fibrosis of the corpus cavernosum in STZ-induced diabetic rat model. In this study, the~     researchers investigated the efficacy and safety of the herbal formula (KBMSI-2) in the~     treatment of ED.~      Material and Methods: Patients were instructed to take investigational products (KBMSI-2 6g~     or placebo) twice a day for 8 weeks at least 1 hour after food intake. The primary efficacy~     variable was the change in the EF domain scores of the IIEF questionnaire from baseline.~     Secondary efficacy measures included change in all domain scores of the IIEF from baseline,~     change in question 2 and 3 of the SEP2,3, from baseline.~   "
88165|NCT02413086|"~     Diabetic Foot as the popular chronic complications of diabetes, is one of the main factors~     leading to limb amputation, it was reported that the amputation rate is 15 times of the~     non-diabetic patients. Common surgical amputation is not only about high plane amputation but~     also bring a tremendous mental stress to patients which may affect the quality of life~     seriously. Diabetic foot patients facing the great risk of serious infection, endotoxemia ,~     and septic shock which could be the main cause of death before amputation. It become an~     important topic that how to control the infection, reduce the amputation plane, save the~     function as possibility, and improve the life quality of the patients as well.~      This study is based on years of clinical experience of and brings out early-stage~     amputation concept firstly in China with a systematic exposition, experimental research and~     clinical research. Early-stage amputation refers to cut in the normal tissue from the~     inflammatory tissue at the junction line of limbs, in order to achieve more retained stump,~     block endotoxin absorption and improve the quality of life of patients. External therapy of~     herbs chitosan can promote granulation tissue regeneration and control of local infection, it~     solved the problem of difficult wound healing and it is a reliable guarantee of early-stage~     amputation.~   "
88166|NCT02413073|"~     There are no studies in the literature evaluating the vibration of the whole body in patients~     with chronic renal failure. The study aims to assess the effectiveness of whole body~     vibration in patients with renal disease in the final phase in the interdialytic period. It~     will be a randomized, triple-blind, controlled and randomized. The pilot study will be 20~     individuals initially. In intervention patients will be randomly divided into two groups:~     sham platform and platform. As a result it is expected that the training of whole body~     vibration may promote patient compliance, since it requires less physical effort for~     implementation and greater comfort in the application, thus allowing the sedentary and / or~     less active patients can benefit by to minimize the harmful effects of physical inactivity~     associated with pre-existing kidney problems.~   "
88167|NCT02413060|"~     The purpose of this study is to determine whether the long-term effects of high-intensity~     progressive resistance training could improve glucose and lipid metabolism in chinese type 2~     diabetes.~   "
88168|NCT02413047|"~     The immunogenicity of anti-tumor necrosis factor alpha (anti-TNF) therapy in inflammatory~     bowel disease (IBD) is an important cause of loss of response to therapy that may lead to~     escalation of dose or discontinuation of therapy. Antibodies may develop to infliximab (ATI)~     or to adalimumab (ATA) and cause this loss of response, also known as a secondary loss of~     response. An alternative approach is the addition of immunomodulator (IM) therapy to~     counteract the antibody response and regain efficacy of the biologic medication. The~     investigators' goal is to treat patients' who have lost response to adalimumab or infliximab~     with an immunomodulator with the goal of eliminating the circulating antibodies to the~     anti-TNF and restoring efficacy.~   "
88169|NCT02413034|"~     Total joint replacement is a common clinical practice for patients suffering from disabling~     arthritis, since it provides significant pain relief and functional recovering. Nevertheless,~     its outcome is compromised by complications such as periprosthetic joint infection (PJI),~     which is reported to occur in 1 to 4% of primary total knee arthroplasties (TKA), and~     approximately 1% of primary total hip replacements (THR). Despite all efforts to restrain~     PJI, its prevalence may reach even higher proportions if patients undergo a resection~     arthroplasty or irrigation and débridement for infected prosthesis. That said, timely~     diagnosis and early isolation of the infected microorganism is utterly important, if proper~     care is to be delivered.~      The gold standard for the diagnosis of PJI is the isolation of a microorganism from the~     intraoperative cultures, combined with the sonication from retrieved joint implants1. This~     technique applies sound energy to agitate and disrupt biofilm, dislodging adherent bacterias~     to the bone cement, which has been proved to be a more sensitive method than conventional~     intraoperative cultures. False-negative percentages were reported to be 15% in patients who~     did not receive extended antibiotic prophylaxis and 60% if extended antibiotic therapy was~     administered.~      Regardless of an adequate clinical, radiographic and surgical suspicion confirming PJI, an~     organism is not always successfully isolated from the intraoperative cultures, which~     increases false negatives results. This fact has been trying to be explained by several~     authors, some of which postulate that antibiotic prophylaxis could interfere with the~     isolation of the microorganism from the intraoperative cultures. As a result, and acting~     accordingly to this hypothesis, preoperative antibiotics are often withheld until~     intraoperative cultures are obtained, hoping that tissues are not loaded with antibiotics.~     Nevertheless, one should be aware of the adverse consequences of this practice that may~     result in systemic dissemination of infection.~      Moreover, Ghanem and Stephen recently concluded that antibiotic prophylaxis does not~     interfere with the isolation of the microorganism from intraoperative cultures, despite being~     studies that lack statistical power.~      Therefore, it is clear that reported studies in this field support both preoperative~     antibiotic prophylaxis administration, as well its withdrawal, until intraoperative cultures~     are obtained.~      This decision in the department study depends exclusively on the treating surgeon judgment.~     In fact, 48% of all patients admitted at the study hospital with PJI receive preoperative~     antibiotic prophylaxis, which could be related to higher false-negative intraoperative~     culture and sonication results. Thus, the investigators add substances with chelation~     properties to hemoculture containers and then inoculate sonication samples. This practice~     offsets antibiotic interference with intraoperative cultures and has proved to enhance~     microorganism detection rates.~      That said, and given the lack of scientific evidence about this clinical practice the~     investigators are willing to engage a prospective randomized double-blind clinical trial,~     that will allow us to determine whether intraoperative cultures and sonication samples are~     affected by antibiotic prophylaxis.~   "
88170|NCT02413021|"~     The purpose of this study is to determine whether deferasirox is effective in the treatment~     of acute lymphatic leukemia (ALL) and acute Myeloid leukemia (AML).~   "
88171|NCT02413008|"~     This is a phase II, prospective, randomized, double-blind, placebo-controlled, international~     (Spain and Sweden) and multicentre study.~      In the setting of postmenopausal hormone receptor positive breast cancer, treatment with~     aromatase inhibitors (AIs) is the most effective and well-studied therapy. Vaginal dryness is~     one of the most frequently reported symptom caused by this adjuvant therapy which may lead to~     a reduced adherence in breast cancer women.~      This study will explore the safety of 0.005% estriol vaginal gel in this oncological context,~     to demonstrate that this medicinal product is a safe option to treat the vaginal atrophy~     caused by AIs, without a clinically relevant influence in gonadotropins or systemic estrogen~     levels.~      The main objective is to evaluate the levels of Follicle Stimulating Hormone (FSH) after~     treatment with 0.005% estriol vaginal gel in hormone receptor-positive postmenopausal women~     with early stage breast cancer in treatment with Non-Steroidal Aromatase Inhibitors (NSAIs)~     in the adjuvant setting and symptoms of vaginal atrophy.~   "
90782|NCT02378883|"~     The purpose of this study is to evaluate the safety of the Apollo™ Onyx™ Delivery Micro~     Catheter used for delivery of the Onyx™ Liquid Embolic System during brain arteriovenous~     malformation (AVM) embolization procedures.~   "
88172|NCT02412995|"~     The effects of strawberry and sea buckthorn on postprandial glycaemia and insulinemia as well~     as on metabolic profiles were examined in overweight or obese male subjects. The study was~     conducted as a randomised, controlled, single-blinded, 3-way crossover study. Eighteen~     subjects were studied in three 2 h meal tests followed by a subsequent ad libitum meal. Test~     meals contained either sea buckthorn, strawberry or no berries and added sucrose to match~     with respect to sucrose content. Blood samples were collected at baseline and several times~     postprandially. Subjective appetite sensations were recorded at baseline and every 15-20 min~     until 140 min and a subsequent ad libitum intake was recorded. Urine samples were also~     collected at baseline and at several time intervals until 24 hours. Blood and urine were~     subjected to metabolic profiling to investigate potential biomarkers of berry intake.~   "
88173|NCT02412982|"~     This is a pilot study to determine if anti-thrombin III (AT-III) serum concentrations differ~     between patients with normal versus subtherapeutic anti-Xa trough concentrations when placed~     on enoxaparin 30 mg twice daily for VTE prophylaxis. Secondarily, this study will compare two~     enoxaparin dosing strategies.~   "
88174|NCT02412969|"~     This study is to examine the onset of pain relief with two different methods of labor~     epidural. The traditional labor epidural involves the placement of numbing and anti-pain~     medicine in the epidural space which surrounds the spinal cord. In order to take effect, the~     medication has to cross a layer of tissue called the dura. In the current study, the same~     medications are placed in the epidural space after the dura is punctured with a fine needle.~     This research, will help evaluate whether this technique will result in earlier onset of pain~     relief.~   "
88175|NCT02412956|"~     Despite the great health benefits associated with smoking cessation in pregnancy to both~     mother and baby, few studies to date have examined the applications of text messaging or~     other communication technologies for smoking cessation in this population. This project is~     the first step in developing a new dissemination strategy for reaching pregnant smokers. This~     research will explore how a state-of -the-art, interactive and intensive, text messaging~     program, SmokefreeMoms Text, can promote smoking cessation in pregnant smokers. This program~     may have the potential to reach pregnant smokers who are not currently being reached with~     traditional smoking cessation services. The study Aims are: 1) to elicit qualitative feedback~     from pregnant smokers and recent quitters (in the past month) about the concept of~     SmokefreeMoms, the proposed message protocols in SmokefreeMoms, and the proposed messages in~     SmokefreeMoms (Phase 1); 2) To develop and pilot test a prototype of SmokefreeMoms which is~     consistent with Clinical Practice Guidelines (Phase 2), and 3) To conduct a formative~     evaluation of SmokefreeMoms 1.0 with pregnant smokers and recent quitters (Phase 3). 4) To~     measure the likelihood that pregnant women who smoke cigarettes will join an SMS program by~     responding to different types of recruitment messages.~   "
88176|NCT02412943|"~     This study evaluates the transfusion of fresh frozen plasma containing the enzyme PAPP-A2~     into the a female adult. This female adult has a mutated version of PAPP-A2 that prevents the~     unbinding of IGF-1 from IGF binding proteins. The investigator's hypothesize that transfusion~     of plasma with donor PAPP-A2 will lead to the unbinding of IGF-1 from its binding proteins~     and that they will be able to measure free IGF-1 in the blood of this female adult.~   "
88177|NCT02412930|"~     Paravertebral block has been widely used for analgesia. The aim of this study,comparison of~     the effect of ultrasound-guided paravertebral block versus intravenous tramadol for~     postoperative pain control in percutaneous nephrolithotomy.~   "
88178|NCT02412917|"~     This is a multicenter, randomized, double-blind, parallel-group, active controlled~     comparative study of the safety and efficacy of 2 dosing regimens of FV-100 versus~     valacyclovir administered for 7 days in subjects with uncomplicated AHZ(acute herpes zoster).~   "
88179|NCT02412904|"~     rFSH and HMG are both used to controlled ovarian stimulation for patients submitted to IVF.~     However, there is a debate in the literature which one is better to induce ovulation in~     patients receiving GnRH antagonist to block premature Luteinizing Hormone (LH) secretion.~      The investigators propose a Randomized Clinical Trial (RCT) to investigate the differences~     among recombinant FSH and HMG in patients submitted to IVF using GnRH antagonists.~   "
88180|NCT02412891|"~     Evaluation of UroShield device impact upon side effects and complications of urinary~     catheter usage.~      The use of urinary catheters is a common medical practice in the perioperative setting.~      As such, it exposes the patient to certain comorbidities, including urinary tract infections.~      The infectious process is known to begin with a development of a biofilm on the catheter's~     surface. This fact makes it an attractive target for UTI prevention technology.~      Ultrasound waves were shown to reduce biofilm buildup in-vitro. We plan to determine the~     efficacy of this method in vivo.~   "
88181|NCT02412878|"~     The purpose of the study is to compare once-weekly carfilzomib dosing in combination with~     dexamethasone to twice-weekly carfilzomib dosing in combination with dexamethasone in~     subjects with relapsed and refractory multiple myeloma, previously treated with bortezomib~     and an immunomodulatory agent (IMiD).~   "
88182|NCT02412865|"~     The goal of this project is to evaluate the effectiveness (Phase II) of a text-based program~     to be called Quit4Baby to support smoking cessation efforts of pregnant women who smoke.~      In Phase II, Dr. Abroms will conduct a randomized clinical trial among 500 pregnant smokers~     who have been recruited from users of text4baby - the first large scale mobile health~     application in the United States. Developed and operated by Voxiva and Healthy Mothers,~     Healthy Babies (HMHB)—collaborators in this program -text4baby is a free national service~     that has enrolled more than 800,000 pregnant women and mothers of infants 0-1 nationwide and~     delivered more than 150 million health messages to them including messages encouraging them~     not to smoke during pregnancy and referring them to quit lines.~      Hypothesis 1: Pregnant smokers who receive quit4Baby + text4Baby will demonstrate higher~     levels of knowledge about the dangers of second hand smoke and the benefits of smoking~     cessation for mothers and their infants than text4baby only users.~      Hypothesis 2: Pregnant smokers who receive quit4baby + text4baby will report significantly~     higher rates of calling a quit line, discussions with their health provider and/or use of~     cessation counseling than those who receive Text4baby alone.~      Hypothesis 3: Pregnant smokers who receive quit4baby + text4baby will have significantly more~     favorable quitting outcomes compared with text4baby alone.~   "
88184|NCT02412839|"~     This study will enroll 150 healthy volunteers, and the grouping is as follows: group 20-39~     (30 males and 30 females); group 40-59 (30 males and 30 females); and group 60-79 (15 males~     and 15 females). The sublingual microcirculation will be examined with the incident dark~     field video microscope (Cytocam，Braedius Battery Powered Transilluminator). The study aims to~     compare the differences of microcirculation among the three groups and between genders.~   "
88185|NCT02412826|"~     The purpose of this study is to conduct a pilot test of an abdominal acoustic sensor on~     patients with acute pancreatitis to determine the correlation of acoustic signals with~     symptoms reported by the patient.~   "
88186|NCT02412813|"~     This is a prospective, randomized, multi-center, metal hypersensitivity study comparing~     OXINIUM and cobalt chrome femoral components in subjects with failed total knee arthroplasty~     (TKA).~   "
88187|NCT02412800|"~     Postoperative acute lung injury (ALI) during the first 72 hours after liver transplantation~     is not uncommon. Injury may occur because liver transplantation is often associated with~     prolonged operative time, large volumes of fluid administration and transfusion, as well as~     inflammatory responses related to ischemia-reperfusion injury. For more precise perioperative~     fluid and hemodynamic management, modern monitoring systems, such as the pulse contour~     cardiac output (PiCCO) system, have been devised and reported in recent years. The PiCCO~     system uses the thermodilution technique to determine the cardiac index (CI) and thoracic~     fluid indices such as the intrathoracic blood volume index (ITBVI), extravascular lung water~     index (EVLWI), and pulmonary vascular permeability index (PVPI), all of which may reflect~     pulmonary fluid and injury status. However, perioperative changes in thoracic fluid indices~     in liver transplantation and their associations with postoperative ALI are not yet clear. In~     this study, the investigators aimed to determine patterns of change in perioperative thoracic~     fluid indices and compare these changes in recipients who did or did not develop~     postoperative ALI. Furthermore, the investigators will also try to determine the potential~     risk factors following liver transplantation.~   "
88188|NCT02412787|"~     This extension study will allow participants that completed Study HGT-HIT-094 to continue~     receiving Elaprase treatment in conjunction with idursulfase IT or to continue receiving~     Elaprase treatment and begin concurrent IT treatment for those that did not received~     idursulfase IT treatment in Study HGT-HIT-094.~   "
88189|NCT02412774|"~     The purpose of the present study is to evaluate the effect of replacing diet beverages with~     water on weight loss and biochemical indicators for insulin sensitivity and cardiometabolic~     risk factors of diabetic obese and overweight female adults when they are in a~     multidisciplinary weight loss plan.~   "
88190|NCT02412761|"~     Children are increasingly being diagnosed with essential hypertension and the absence of~     comparative effectiveness research in antihypertensive therapies has contributed to~     considerable differences in prescribing practices among physicians treating children with~     essential hypertension.~      This study will consist of a series of systematically-administered n-of-1 trials among~     children to verify the need for ongoing antihypertensive treatment and if so, to identify the~     preferred single drug therapy.~   "
88191|NCT02412748|"~     The number of children living apart from their fathers has grown nationally, and the greatest~     percentage is evident among African American (AA) families; two-thirds of all African~     American children live in households without their biological father. Research supports the~     importance of positive fathering in the lives of children. But in order for children to~     benefit from their fathers' involvement, the father-child relationship must be timely and~     sustained. This study will test culturally relevant interventions aimed at increasing~     non-resident (not living with the child) AA fathers' involvement with their children.~   "
88192|NCT02412735|"~     This is a prospective, multicenter, randomized, double-blind, placebo-controlled Phase 3~     study designed to evaluate the safety and efficacy of Mesoblast's rexlemestrocel-L alone or~     combined with hyaluronic acid (HA) in subjects with chronic low back pain (> 6 months)~     associated with moderate radiographic degenerative changes of a disc~   "
88193|NCT02412722|"~     The purposes of this study are to: evaluate the safety and tolerability of MLN0128 milled~     active pharmaceutical ingredient (API) capsules administered both as a single agent and in~     combination with paclitaxel, to characterize the effect of a high-fat meal on the~     pharmacokinetics (PK) of MLN0128 milled API capsules, and to characterize the PK of MLN0128~     milled API capsules when administered on an empty stomach approximately 24 hours after~     paclitaxel infusion.~   "
88194|NCT02412709|"~     The purpose of this project is to test a new, very compact, 12-lead ECG device as a way to~     detect long QT syndrome (LQTS) in infants. The device -- called QTScreen -- was developed in~     Phase I of this project.~      In Phase II, the goals are to test the capacity of the device for LQTS screening in newborns~     and to obtain prevalence data on LQTS in California.~      The 4 main objectives are:~        1. To validate the capacity of QTScreen for LQTS screening in newborns.~        2. To determine the extent to which parents are able to use QTScreen on their babies at~          home.~        3. To survey end-user experience and opinions.~        4. To estimate the LQTS prevalence in California.~   "
88195|NCT02412696|"~     This study is testing the hypothesis of whether continuous positive airway pressure (CPAP)~     therapy improves placental histopathology and secretory function. The main aims of the study~     are to identify shared mechanisms between obstructive sleep apnea and preeclampsia, both~     common highly morbid conditions.~   "
88196|NCT02412683|"~     Subgroups of patients with radically operated colorectal cancer can have a better prognosis~     by over six months are treated with chemotherapy. This beneficial effect may be enhanced~     somewhat by providing a combination of chemotherapy and the addition of oxaliplatin. It is~     known that this treatment additions increase the risk of neurotoxic side effects such as~     sensitivity to cold, numbness and tingling in hands or feet, muscle cramps, pain, taste~     disorders and swallowing difficulties.~      The aim is to investigate how colorectal cancer patients with oxaliplatin adjuvant~     chemotherapy experience neurotoxic effects and if the experience of the symptoms change over~     time during treatment and how symptoms affect patients' daily lives and quality of life.~   "
88239|NCT02412124|"~     This pilot clinical trial studies a peer-to-peer support program in improving quality of life~     outcomes in patients with gynecologic cancer and their caregivers. Peer-to-peer support and~     mentoring may help improve quality of life and reduce symptoms of distress in gynecologic~     cancer patients and their families.~   "
88197|NCT02412670|"~     This phase II trial studies how well giving chemotherapy before surgery works in treating~     patients with aggressive upper urinary tract cancer. Drugs used in chemotherapy, such as~     methotrexate, vinblastine, doxorubicin hydrochloride, cisplatin, gemcitabine hydrochloride,~     and carboplatin, work in different ways to stop the growth of tumor cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. Removing the~     affected upper urinary tract by surgery is the recommended treatment for upper urinary tract~     cancer, but can cause loss of kidney function and prevent patients from being able to receive~     chemotherapy after surgery. Giving chemotherapy before surgery, when the kidneys are working~     at their maximum, may allow less tissue to be removed during surgery and may be more~     effective in treating patients with high grade upper urinary tract cancer.~   "
88198|NCT02412657|"~     Interscalene brachial plexus block provides excellent but time limited analgesia. Intravenous~     dexamethasone increases the analgesic duration of a single-shot interscalene block with~     ropivacaine for shoulder arthroscopic surgery. We want to evaluate the effect of two~     different doses (dexamethasone 10 mg i.v. vs 4 mg i.v. vs placebo) on the analgesic duration~     of a single-shot inter scalene block. Our study hypothesis is that dexamethasone 4 mg i.v. is~     equivalent to dexamethasone10 mg i.v. in prolonging the analgesic duration of a single-shot~     interscalene block with ropivacaine.~   "
88199|NCT02412644|"~     12 weeks open label with Otezla® and NUVB, followed by 6 month double blind Otezla®~     (apremilast) or placebo to subjects who obtain PASI 75 at week 12 of phototherapy~   "
88200|NCT02412631|"~     Some individuals smoke with the perception that smoking helps control body weight. Smokers~     gain an average of as much as 10 pounds in the months following smoking abstinence, with~     heavier and more-dependent smokers gaining more weight. T The Mayo Clinic Nicotine Research~     Program will randomize 100 nondiabetic, overweight or obese adult smokers to active~     lorcaserin or placebo for 24 weeks; all of the subjects will receive open-label varenicline~     for 12 weeks. The purpose of this study is to assess the efficacy of a 24-week course of~     lorcaserin for decreasing weight gain after stopping smoking.~   "
88201|NCT02412618|"~     A randomized double--‐blinded comparison of same--‐day mifepristone and misoprostol with~     misoprostol only for cervical preparation in second--‐trimester surgical abortion in 100~     women at 14 0/7--‐19 6/7 weeks gestation.~   "
88202|NCT02412605|"~     Records of women who had trophectoderm biopsy for sex selection over the last 3 years will be~     reviewed and its outcome will be compared to other records of women who had IVF/ICSI without~     embryo biopsy.~   "
88203|NCT02412592|"~     Chronic hepatitis B (CHB) is a serious liver disease worldwide, and the leading cause of~     cirrhosis and hepatocellular carcinoma (HCC). HBeAg seroconversion is considered to be the~     satisfied endpoint of antiviral therapy in HBeAg-positive chronic hepatitis B patients.~     However, HBV reaction, even reverse back to HBeAg positive and clinical relapse could occur~     in some patients who achieved HBeAg seronconversion by interferon treatment. In this study,~     the long-term efficacy of interferon therapy in HBeAg positive patients achieved HBeAg~     seronconversion after interferon treatment and the factors associated with viral and clinical~     relapse will be observed.~   "
88204|NCT02412579|"~     The purpose of this study is to determine whether genetic markers unique to liver cancer are~     present and to assess usefulness as a diagnostic tool.~   "
88205|NCT02412566|"~     While fish-oil lipid emulsions have shown a benefit to the treatment of parenteral nutrition~     (PN)-associated cholestasis, the dose is limited to 1 g/kg/day. Similarly, in early~     PN-associated cholestasis the dose of soy-based lipid is limited to 1 g/kg/day. Often the~     calories that are lost from this relative decreased dose of lipids can be provided by~     adjusting the dextrose content of the PN solution and providing a higher glucose infusion~     rate. In some cases, this is not tolerated or even with maximizing this strategy, growth is~     inadequate. Inadequate growth is a direct cause of poor outcomes including poorer~     neurological outcome, failure to be able to stop mechanical ventilation and poorer growth of~     their often already damaged intestine. These outcomes can lead to severe disability and~     death. Therefore, infants receiving only 1 g/kg/day of lipids who are not adequately growing~     must have a greater intake of lipids to meet their needs for weight, length, and head~     circumference growth.~      SMOFlipid (Fresenius Kabi, Bad Homburg, Germany) contains a mixture of 4 different lipid~     sources: soybean oil providing essential fatty acids, olive oil rich in monounsaturated fatty~     acids which are less susceptible to lipid peroxidation than polyunsaturated fatty acids,~     medium-chain triglycerides showing a faster metabolic clearance than long-chain~     triglycerides, and fish oil for the supply of omega-3 fatty acids. It is safe to give in what~     is the usual dose for lipid therapy in neonates of 3 g/kg/day, rather than being limited to 1~     g/kg/day as we do with cholestatic infants receiving Omegaven or soy lipids. Because this~     product includes both omega-6 and omega-3 lipids, it provides the benefits of the omega-3s~     for the liver and provides more than enough omega-6s to meet essential fatty acid~     requirements. Its use in situations in which growth is inadequate in babies who must be~     restricted to 1 g/kg/day can be expected to improve their growth and likely markedly increase~     their chances of both a good neurological outcome and survival.~      Purpose: We want to find out if this new intravenous fat mixture (SMOFlipid) will help~     promote good growth while reducing the severity (or seriousness) of liver disease or help put~     an end to liver disease in infants.~   "
88206|NCT02412553|"~     The study is proposed as a 2-year single site, open-label clinical trial of enteral nutrition~     or the specific carbohydrate diet in patients with active CD or UC. Patients seeking care in~     the outpatient clinics of the Division of Gastroenterology at Massachusetts General Hospital~     will be approached for participation in the trial during their routine outpatient~     appointments. All patients are required to have a diagnosis of CD or UC confirmed using~     standard clinical, endoscopic, and histologic criteria. Eligible patients will complete an~     office visit to confirm eligibility for the study and informed consent will be obtained. They~     will then be scheduled for a routine colonoscopy as part of their standard clinical care to~     objectively confirm active disease and obtain biopsies for microbiome and gene expression.~     The investigators will obtain prior authorization from the subject's insurance company for~     such colonoscopy, or if it is not covered by the insurance, the investigators will use study~     funds to pay for the procedure. They will then be assigned to one of two dietary intervention~     arms based on their preference and will meet with the study registered dietician at the MGH~     Clinical Research Center (CRC) metabolism and nutrition unit. There, they will receive~     instruction on the components of the assigned dietary therapy arm - partial elemental diet~     (enteral nutrition) or specific carbohydrate diet, and will complete a baseline food record~     (FR). They will adhere to the dietary therapy for 6 weeks after which they can resume normal~     diet. Clinical, biochemical, nutritional, and microbiological parameters will be measured~     during and for 6 weeks following the study. They will have 5 study visits during this time.~   "
88240|NCT02412111|"~     This is a Phase 3, randomized, double-blind, ivacaftor-controlled, parallel-group,~     multicenter study in subjects aged 12 years and older with CF who are heterozygous for the~     F508del-CFTR mutation and a second CFTR allele with a gating defect that is clinically~     demonstrated to be ivacaftor responsive.~   "
88207|NCT02412540|"~     The goal of this study is to determine effective treatment and identify diagnostic biomarkers~     for Nonalcoholic steatohepatitis (NASH). Individuals that take part in the study will be~     participating in either a weight loss surgery (WLS) group or a comprehensive lifestyle~     intervention (CLI) group. People in the WLS group will receive vertical sleeve gastrectomy~     (VSG). The CLI group will receive dietary, activity and behavioral interventions provided by~     trained study staff.~   "
88208|NCT02412527|"~     Objective: Computerized sleep staging has been verified in a normal population. This study~     attempts to investigate and verify the interpretation of this computerized sleep staging~     program in patients with sleep disorders, and improve the accuracy of actigraphy algorithm~     for sleep duration and postures.~        1. Compare the accuracy of computerized sleep-wake analysis with current sleep quality~          indicators: through actigraphy and heart rate sensors, compare the computerized~          sleep-wake analysis program with polysomnography, and verify its clinical reliability~          and validity in sleep disorder patients.~        2. Establish the sleep posture detection system: through three-axis accelerometer, develop~          algorithms for position recording and monitoring during sleep, and upgrade its accuracy~          according to photography.~      Methods: Patients ranged from age 20-50 with primary insomnia, periodic limb movement in~     sleep, simple snores, and obstructive sleep apnea will be enrolled in our study. Routine~     polysomnography will be applied in sleep center at Chang Gung Memorial Hospital, Taoyuan, as~     well as sleep-related questionnaires. At the same time, actigraphy and heart rate sensor~     patch will be used for sleep posture detection and further computerized sleep-wake analysis.~     Results will be verified the consistency by comparison with sleep-wake analysis from~     polysomnographic data and sleep-related questionnaires.~   "
88209|NCT02412514|"~     This is a phase IV open-label randomized clinical trial that will compare intestinal and~     humoral immunity in infants receiving inactivated poliovirus vaccine (IPV) and two or three~     doses of bivalent oral poliovirus vaccine (bOPV).~   "
88210|NCT02412501|"~     The purpose of this trial is to assess the safety and efficacy of the Resolute Onyx~     Zotarolimus-Eluting Coronary Stent System for the treatment of de novo lesions in native~     coronary arteries that allows the use of a 2.0 mm diameter stent.~   "
88211|NCT02412488|"~     The purpose of the RIO 2 International study is to provide clinical and economic evidence to~     support moving the LINQ™ insertion procedure outside these traditional locations within the~     hospital, referred to as out-of-cathlab.~   "
88212|NCT02412475|"~     Successful treatment for children and young adults with relapsed acute myeloid leukemia (AML)~     continues to be a significant challenge. Despite relative improvements in survival for~     patients with newly diagnosed AML, an estimated 40-60% will relapse with the majority~     eventually dying of their relapsed disease. Attaining a subsequent remission in patients who~     relapse is the initial critical step toward achieving a potential cure. As chemotherapy~     resistance is one of the primary drivers of poor treatment response and subsequent relapse in~     AML, identifying methods to reverse this resistance are desperately needed. This clinical~     trial is aimed at improving the remission re-Induction rates for children and adults with~     relapsed or refractory AML through epigenetic modifying agents that have the ability to~     reverse chemotherapy resistance. Decitabine, a DNA methyltransferase inhibitor (DNMTi) and~     Vorinostat, a histone deacetylase inhibitor (HDACi), are two epigenetic modifying drugs that~     act on the methylation of proximal promoter regions of genes and on proteins involved in the~     wrapping of DNA around histones, respectively. Both processes play a critical role in~     regulating gene expression, and frequently these genes are involved in chemotherapy~     resistance. These agents are FDA-approved for treatment in adult hematologic malignancies,~     making this an opportune time to begin testing these novel therapies in pediatric leukemia~     trials. This study will investigate chemotherapy priming of relapsed/refractory AML using~     Decitabine and Vorinostat given for 5 days prior to standard re-Induction with Fludarabine,~     Cytarabine and G-CSF for children and adults.~   "
88213|NCT02412462|"~     This is a Phase 1 clinical study to investigate the safety, pharmacokinetics and~     pharmacodynamics of AB-16B5 in patients with an advanced solid malignancy. AB-16B5 is a~     humanized monoclonal antibody that inhibits the activity of the secreted form of clusterin~     (sCLU), a potent inducer of the epithelial-to-mesenchymal transition (EMT). Eligible subjects~     will have a disease that has been refractory to prior therapy and is unlikely to benefit from~     known therapies.~   "
88214|NCT02412449|"~     The primary purpose of this study is to compare the PK parameters of a single dose of a test~     tablet formulation of AKB-6548 relative to a single dose of the reference AKB-6548 tablet~     formulation, both treatments administered without food, and to compare the PK parameters of~     the test tablet formulation given under fed and fasted conditions.~   "
88215|NCT02412436|"~     This study is being done to evaluate the effect of HIV and TB treatment on a commonly used~     birth control method. This study is being done on women who are infected with HIV and TB and~     are taking efavirenz (EFV; Sustiva®; an anti-HIV medication), rifampicin (RIF; an anti-TB~     medication) and isoniazid (INH; an anti-TB medication). The purpose of this study is to find~     out the best schedule to give depot medroxyprogesterone acetate (DMPA; a hormonal birth~     control method that is given as a shot every 3 months) in women with HIV and TB who are also~     taking EFV and RIF. This study will also try to find out if a 150 mg injection of DMPA is~     effective in preventing ovulation, the process by which the ovaries (the ovaries are part of~     the female reproductive system) release an egg for fertilization, for 12 weeks in women who~     are taking EFV and RIF. Another purpose of this study is to find out if it is safe to take~     RIF, EFV and DMPA at the same time.~   "
88216|NCT02412423|"~     In beijing model for haploidentical transplant, the rate of acute graft-versus-host disease~     (GVHD) from maternal or collateral donors was significantly higher than that from other kins.~     To reduce the GVHD incidence from maternal or collateral donors, post-transplantation~     cyclophosphamide is planned to be added into the protocol in beijing model.~   "
88217|NCT02412410|"~     This is a pilot study designed to elucidate sleep/wake patterns and associated cognitive~     efficacy of laborists involved in shift work at Mayo Clinic Rochester.~   "
88218|NCT02412397|"~     To collect medium to long-term survivorship implant outcomes on the DePuy Global Unite~     Shoulder System~   "
90948|NCT02376725|"~     The purpose of this study is to determine if phacoemulsification with intraocular lens~     implant (phaco/IOL) alone or combined with goniosynechialysis is better at controlling~     intraocular pressure in subjects with primary angle closure.~   "
88219|NCT02412384|"~     Circulating tumor cells (CTCs) have the potential to provide a surrogate for'real-time~     biopsy' of tumor biological activity. Enumeration and molecular characterization of CTCs in~     lung cancer could play an important role in diagnosis, predicting the risk for tumor~     recurrence, and providing novel target therapy biomarkers. In view of these facts, the~     investigators wanted to demonstrate the value of multiparameter flow cytometry in detecting~     human tumor cells of lung cancer in normal peripheral blood after cryosurgery with or without~     dendritic cell(DC)-cytokine-induced killers(CIK) treatment, and the investigators also~     compared the specificity with reverse transcriptase polymerase chain reaction (RT-PCR)~     method.~   "
88220|NCT02412371|"~     This study seeks to establish the recommended Phase 2 dose (RPTD) of veliparib in combination~     with concurrent Paclitaxel/Carboplatin-based chemoradiotherapy and consolidation with~     Paclitaxel/Carboplatin-based chemotherapy (Phase 1 portion) and to assess whether the~     addition of oral veliparib versus placebo to Paclitaxel/Carboplatin-based chemoradiotherapy~     with Paclitaxel/Carboplatin consolidation will improve progression-free survival (PFS) in~     subjects with Stage III non-small cell lung cancer (Phase 2 portion).~   "
88221|NCT02412358|"~     -  Objective: To compare clinical results of three types of manual tooth brushes on~          gingivitis and plaque removal efficacy.~        -  Material and Methods: This study is a single blind randomized trial with crossover~          design which involved 30 periodontally healthy individuals. At baseline professional~          plaque removal and oral hygiene instruction are performed for all the students, then~          they are asked to avoid brushing for 1-2 days. Thereafter plaque and gingivitis scores~          are measured using plaque and gingival indices (PI and GI). Then subjects are instructed~          to use Pulsar tooth brush for a two-week period and then, GI and PI indices are assessed~          again. After passing one-week period for wash out, subjects don't brush for 1-2 days and~          indices are recorded again. The same procedure are done for Cross action, and Butler 411~          tooth brushes respectively.~   "
88222|NCT02412345|"~     The primary objective of this study is to determine the impact of the shock wave application~     in renal transplant patients with diagnosis of erectile dysfunction. Secondary objectives are~     to assess the effects of therapy on quality of life and depression.~      It is expected that with the study is defined the usefulness of the therapy and the~     dissemination of knowledge generated for change in clinical management in renal transplant~     patients with erectile dysfunction.~   "
88223|NCT02412332|"~     The purpose of this study is to determine whether cell therapy with autologous adult stem~     cells (from bone marrow and/or fat) is safe in the treatment of advanced Chronic Obstructive~     Pulmonary Disease (COPD).~   "
88224|NCT02412319|"~     Asses the efficacy and safety of the Anti hepatitis B placenta transfer factor injection in~     the treatment of HBeAg positive chronic hepatitis B.~   "
88225|NCT02412306|"~     Open-label combined two-part multi-center clinical study to evaluate the efficacy, safety,~     and tolerabillity of blinatumomab in adult and pediatric Japanese subjects with R/R~     B-precursor ALL.~      The Phase 1b part will investigate the safety, efficacy, PK and PD of blinatumomab in adult~     Japanse subects with R/R B-precursor ALL to determine the MTD (maximum tolerated dose) in~     both adult and pediatric subjects. Once a dose has been selected in the Phase 1b part, the~     Phase 2 part will assess the safety and efficacy of the recommeded dose level of blinatumomab~     identified in the Phase 1b portion of the study in the adult study population.~      The protocol was amended to extend the study. Adult and pediatric subjects in the expansion~     cohort may receive up to 5 cycles of investigational blinatomumab and may receive commercial~     blinatomumab after a minimum of 2 cycles of the investigational drug. The secondary endpoint~     of complete remission/partial hematological remission (CR/CRh*) versus CR was specified, for~     clarity, throughout the protocol, and the comparable endpoint in pediatric subjects, M1~     remission, was specified to align with the Statistical Analysis Plan.~   "
88226|NCT02412293|"~     There is limited evidence from community-based interventions to guide the development of~     effective maternal, perinatal and newborn care practices and services in developing~     countries. Investigators planned to evaluate the impact of a low-cost package of~     community-based interventions implemented through government sector lady health workers~     (LHWs) and community health workers (CHWs) of a NGO namely Aga Khan Health Services on~     perinatal and neonatal outcomes in a sub-population of the remote mountainous district of~     Gilgit, Northern Pakistan.~      A community-based package for use by LHWs and CHWs geared towards prevention and promotion of~     maternal and newborn health practices and services will be developed based on formative~     research in the study district. The package will include promotion of antenatal care,~     adequate nutrition, skilled delivery and healthy newborn care practices at household level.~     The health workers will be trained in recognition of danger sign that warrant referral to~     health care service. LHWs and CHWs will delivered the package via community awareness~     sessions and two one-to-one counselling sessions to pregnant women during third trimester and~     five newborn assessment visits in the neonatal period. In addition to this, community~     mobilization activities included formation of CHCs and creation of support for the uptake of~     the interventions. Control areas will continue to receive the routine standard health~     services of governmental and non-governmental organizations in the area. The intervention~     areas will receive the intervention package in addition to the routine standard health~     services. Outcome measures will include changes in maternal and newborn-care practices and~     perinatal and neonatal mortality rates between the intervention and control areas.~   "
88227|NCT02412280|"~     Validity of MELD vs MELD XI in assessing 1 year survival after living donor liver~     transplantation.~   "
88228|NCT02412267|"~     The purpose of this study is to determine the efficacy and safety of ofatumomab in~     combination with ICE chemotherapy in subjects with relapsed/refractory DLBCL following~     failure to combination rituximab and anthracycline based chemotherapy. Participants with the~     option of potentially curative stem cell therapy may proceed to high dose chemotherapy and~     stem cell rescue. Participants with disease not considered curable with stem cell therapy,~     ineligible for or decline stem cell therapy may receive up to a maximum of 6 cycles of study~     drugs.~   "
88241|NCT02412098|"~     This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral~     dose of eleclazine in participants with normal and impaired hepatic function. Participants in~     the healthy control group will be matched to participants with impaired hepatic function by~     age (± 5 years), gender, and body mass index (± 10%).~   "
88229|NCT02412254|"~     The investigators will conduct a small pilot study that will randomize ~ 40 70-84 year-old~     adults with hearing loss to best-practices hearing rehabilitative treatment (hearing~     assessment, counseling, fitting of amplification devices) versus a successful aging~     intervention (one-on-one counseling/education sessions on successful aging topics).~     Participants will be followed for 6 months, and outcomes will focus on communication, quality~     of life, cognition, and other functional surveys. This pilot study is in preparation for a~     larger planned trial to investigate if hearing loss treatment can reduce cognitive decline~     and dementia in older adults.~   "
88230|NCT02412241|"~     This four-year, prospective, longitudinal study will evaluate and validate a patient-reported~     outcome measure, clinician-reported outcome measures, and imaging techniques in assessing~     characteristics, trajectory, and progression of lymphedema and fibrosis (LEF) in oral cavity~     and oropharyngeal cancer patients.~      This clinical trial studies patient-and-clinician-reported measures as well as standard~     imaging methods to see how accurate they are in identifying and evaluating lymphedema~     (swelling) or fibrosis (tough or tight tissue) in the head and neck region of patients~     receiving treatment for newly diagnosed stage II-IV oral cavity or oropharyngeal cancer.~     Lymphedema and fibrosis (LEF) can lead to physical symptoms, such as trouble swallowing and~     chewing, as well as psychological and emotional symptoms, such as negative body image and~     avoiding social interactions. Finding an accurate test to identify and evaluate LEF may allow~     doctors to treat LEF more quickly and control symptoms more effectively, and thus provide~     patients with a better quality of life.~   "
88231|NCT02412228|"~     The goal of this proposal is to develop a more effective and better tolerated regimen.~     Ixazomib appears to have greater activity than bortezomib with less peripheral neuropathy.~   "
88232|NCT02412215|"~     This study aims to assess the rotational stability of the new collameric Nanoflex toric~     intraocular lens (T-IOL) by STAAR inserted in astigmatic patients after cataract surgery.~      The purpose of this study is also to determine whether the use of a toric intraocular lens~     (T-IOL) improves visual acuity.~   "
88233|NCT02412202|"~     Switching from positive airway pressure ventilation to spontaneous ventilation during weaning~     from mechanical ventilation, pulmonary edema may occur and in this case, doppler~     echocardiographic (U/S) indices of cardiac dysfunction correlates with the concentration of~     fluid in interstitial space.~      Forty consecutive mechanically ventilated critical ill patients who fulfill criteria for~     weaning from mechanical ventilation, will be included in this study. All patients will be~     evaluated daily and when the patients fulfill weaning criteria them they will undergo a~     2-hour spontaneous breathing trial (SBT) through a T-piece.~      Before and after SBT cardiopulmonary function will be assessed by thermodilution and~     echocardiography. In patients with preserved LV systolic function, an echocardiographic index~     of diastolic dysfunction (E/Em ratio) before preforming SBT may identify high risk patients~     for increasing extravascular water in weaning.~      In addition, the investigators expect to find positive correlations (p<0.05) between~     pulmonary extravascular lung water and echocardiographic indices (such as E/Em ratio) during~     SBT.~   "
88234|NCT02412189|"~     The arterial blood pressure affects the ratio between filtration and reabsorption of fluids~     in the circulating blood volume and thereby the hematocrit. During induction of anesthesia~     blood pressure, hemoglobin level and hematocrit decreases. The aim of the study is to~     evaluate weather a maintained blood pressure with norepinephrine during anesthesia induction~     reduces the decrease in hematocrit.~   "
88235|NCT02412176|"~     Background Right ventricular (RV) artificial apical pacing can negatively impact synchrony of~     left ventricular contraction. The pacing from the septum of the RV can present an advantage~     in terms of less expressed dyssynchrony and reduced negative impact on left ventricular (LV)~     function. However, results of randomized studies comparing apical and septal pacing are not~     uniform. All these results have been affected by improper implantation of the septal lead,~     with many apparently septal leads being, in fact, implanted off-septum. The aim of the study~     is to compare true septal pacing with other RV pacing locations.~      Methods/Design This is a prospective, randomized, single center study. Patients with standard~     indications for cardiac pacing with the expectation of high percentage RV pacing will be~     enrolled. They will be randomized into apical and septal pacing. The real location of leads~     in patients randomized to septal pacing will be confirmed using cardiac CT. After cardiac CT,~     three groups of patients will be created: 1) apical pacing, 2) true septal (in which the~     position of the lead has been verified to be in the septum), and 3) apparent septal (in which~     the position of the lead was found to be off-septum). Primary end-point are changes in~     standard echocardiographic parameters (LV ejection fraction, LV end-systolic volume, and LV~     end-diastolic volume) and the concentration of N-terminal pro brain natriuretic peptide~     (NT-proBNP) from baseline to 6 months, 1 year and three years. Secondary end-points are~     changes in echo-parameters of LV synchrony.~      Discussion It is hypothesized that correct septal pacing will be associated with reduce~     negative impact on the function of the left ventricle (i.e. smaller decreases in LV EF and~     smaller increases in LVEDV, LVESV) and NT-proBNP, and less expressed LV dyssynchrony.~   "
88236|NCT02412163|"~     This study further evaluates the safety profile and efficacy of the Ellipse IM HTO Nail~     system in subjects with osteoarthritis and varus malalignment of the knee. All subjects will~     receive treatment with the Ellipse IM HTO Nail System and followed for six months.~   "
88237|NCT02412150|"~     The purpose of the present study was to compare the effect of dexmedetomidine which is~     administered during emergence in adult patients undergoing elective thyroidectomy on smooth~     emergence form general anesthesia (reducing agitation or coughing, signs of hypertension or~     tachycardia, or etc.) and postoperative outcome (postoperative bleeding and hospital~     staying).~   "
88238|NCT02412137|"~     To measure the effectiveness of counseling on brace-wear compliance and curve progression in~     patients with adolescent idiopathic scoliosis. The investigators hypothesize that compliance~     is increased when it is measured and used to counsel patients, and therefore those patients~     will have less curve progression and fewer would need surgery.~      A second purpose is to evaluate whether there is a correlation between BMI and brace~     effectiveness. Proposed theories for decreased effectiveness in patients with elevated BMI~     have included decreased compliance due to discomfort and decreased force exerted on the curve~     due to the larger habitus.~   "
90949|NCT02376712|"~     The study aims to evaluate the diagnostic value of urinary indices in differentiating~     pre-renal and renal acute kidney injury among critically ill patients.~   "
88242|NCT02412085|"~     This is an open-label, phase IV trial. Adult patients, with moderately to severe, steroid~     dependent, acute ulcerative colitis not previously exposed to anti-TNF, will receive~     subcutaneous golimumab treatment, according to EU marketing authorization from baseline~     through week 14.~      At week 16, patients achieving clinical and endoscopic remission will continue with~     Golimumab, 50 mg or 100 mg (depending on body weight) every 4 weeks, through week 52.~      Patients not achieving clinical and endoscopic remission will be treated with infliximab,~     according to marketing authorization, and followed through week 52. This is not considered as~     an interventional arm but, since infliximab in Italy is considered as the first-line~     treatment for UC patients, as the usual clinical practice.~   "
88243|NCT02412072|"~     A prospective multicenter trial has been started in Korea to evaluate the diagnostic accuracy~     of endometrial aspiration biopsy compared with D&C in patients treated with progestin for~     endometrial hyperplasia (EH). For conservative treatment of EH, oral progestins are most~     commonly used method with various treatment regimens and more recently, the~     levonorgestrel-releasing intrauterine system (LNG-IUS) also has been used successfully to~     treat EH. However, there is no report about the accuracy of endometrial sampling during~     hormonal treatment for follow-up evaluation of EH. Patients with histologically confirmed EH~     are offered hormonal treatment, one of the following 3 options: oral medroxyprogesterone~     acetate(MPA) 10mg/day for 14days per cycle, continuous oral MPA 10mg/day, or insertion of~     LNG-IUS. Histological surveillance is performed at 3-months or 6-months following initial~     treatment. Endometrial tissues are obtained via endometrial aspiration biopsy using a pipelle~     and D&C. In case of using LNG-IUS, endometrial aspiration biopsy will be done with LNG-IUS in~     uterus and then, after removal of LNG-IUS, D&C will be done. The biopsy findings will be~     compared. The primary endpoint is the consistency of the results of the endometrial~     aspiration biopsy and D&C. The secondary endpoint is the response rate with 3 types of~     progestin treatment at 6 months.~   "
88244|NCT02412059|"~     In this prospective randomized controlled double blind pilot clinical study, we aim to assess~     whether administration of a topical corticosteroid would attenuate epiretinal membrane~     formation following development of retinal tears treated with laser retionpexy.~   "
88245|NCT02412046|"~     The aim of this study is to correlate the intensity and the duration of a mechanical strain,~     applied over the skin of a bedridden paraplegics, with the microvascularization parameters~     (oxygen saturation, blood flow and blood volume) and the early inflammatory mechanism. We~     want to detect the early stage of irreversible damage for each patient. To achieve this goal,~     we measure some specifics data over a group of 48 paraplegics admitted in the hospital for a~     pressure ulcer surgical treatment. The patients are randomly distributed in 4 groups. First~     the interface pressure between the patient body and the air mattress is recorded continuously~     for 3 hours (= the repositioning patient frequency): we have the pressure over each point of~     the patient body in contact with the mattress on this time lap. Then, we will measure the~     microvascularization parameters, using an O2C medical device over a trochanter on a specific~     anatomical area which will be thereafter biopsied. Finally, depending on the group in which~     they were randomly distributed, the patient will undergo a muscle biopsy on his or her~     trochanter at 0h, 1h, 2h or 3h after they lie down on the air mattress. This way, we will be~     able to determine the effect of the mechanical strain duration on the physiologic parameters.~     The following day, the patient is undergoing his or her surgery for removing the necrotic~     area of the bedsore. At the same time, we will recover some of the sample near the bedsore~     which would serve as a maximum inflammatory response. Then a second muscle biopsy will be~     performed on an innervated area to be able to determine a basal concentration of biomarkers.~      The inclusion period for this study will be 3 years. All the patients are followed for 24~     hours then they will be followed by medical staff in their bedsore resection setting.~      The data gained for this study will hopefully help the scientific world to achieve a better~     understanding of the pressure ulcer aetiology. They will also be helpful to achieve a~     mobilization of the patient specific of his or her inherent characteristics with a high~     sensitivity level. This way we will have a more efficient bedsore prevention.~   "
88246|NCT02412033|"~     Intrauterine devices (IUDs) are widely used as reversible contraceptives. Both copper- and~     levonorgestrel (LNG)-releasing IUDs (LNG-IUDs) are safe,cost-effective in the long term and~     equally effective compared with tubal sterilization.~      In addition, the LNG-IUD (Mirena®) provides non contraceptive benefits, such as treatment for~     menorrhagia, dysmenorrhea and anemia. The current use of IUDs among reproductive-aged women~     ranges from 8 to 15% worldwide. Reported complications related to IUD insertion are 8.8%~     insertion failure, 2.8-11.5% cervical problems, 0.2% cervical perforation, 0.2% syncope and~     5.8% expulsion. Insertion failures and cervical problems seem to occur more often among women~     who have never delivered vaginally.~      Cervical stenosis, an immature or small cervix and a significantly ante- or retroverted~     position of the uterus, has been described as factors associated with a difficult sounding of~     the cervical canal or even failure to insert the IUD.~      Misoprostol is an inexpensive prostaglandin E1-analogue, which is associated with few side~     effect. More over several have shown the benefit of misoprostol as a cervical ripening agent~     in non pregnant women. Priming with misoprostol prior to hysteroscopy and dilatation and~     curettage (D&C) in perimenopausal women resulted in increased cervical dilatation and lower~     rate of cervical laceration.~      The effect of misoprostol on the cellular matrix causes dissolution of collagen fiber~     increasing the amount of fluid in the stroma and consequentially causes cervical effacement.~     Fear of pain during insertion, however, might prevent some women from choosing IUD and fears~     of painful and/or difficult placements may lead them to recommend or counsel women on other,~     less effective methods.~      Women's perception of pain is multifactorial and likely to be influenced by cultural~     differences and personal experiences; insertion-related pain is therefore difficult to~     predict. Nevertheless, factors associated with greater pain include nulliparity, not~     currently breastfeeding and longer time since last pregnancy; of these factors, nulliparity~     is the strongest predictor of pain.~      The proportion of women of reproductive age who are nulliparous is increasing, with women~     delaying childbirth and having fewer children or choosing to remain childless. The proportion~     of Caesarean section births has also increased and women who have only ever had a Caesarean~     section are often viewed as nulliparous with respect to IUD placement. Anticipated pain is~     often greater than the actual pain experienced, and the majority of nulliparous women~     experience no more than moderate pain during IUD insertion. However, among nulliparous women~     there is a subset (about 17%) for whom the insertion of IUD is associated with severe~     pain.These women need effective pain relief.~      For most nulliparous, nulligravid or parous women, IUD insertion can be performed~     successfully without cervical priming and with a minimum amount of discomfort. Whether~     selective use of misoprostol has a role in management of pain in certain subsets of women~     (e.g. nulliparous women and those in whom the insertion is non-routine/difficult) has yet to~     be adequately studied.~   "
88247|NCT02412020|"~     This is a double-blind, randomized, placebo-controlled, 2-period crossover, 2-cohort study in~     adult patients with refractory chronic cough.~      The purpose of the study is to assess the efficacy and safety of inhaled PA101 delivered via~     eFlow high efficiency nebulizer for treating refractory chronic cough.~   "
88248|NCT02412007|"~     Activity based therapy is gaining interest for rehabilitation of children with cerebral palsy~     (CP). A home-based comprehensive programme structured on the principles of activity based~     therapy seems to hold promise in the field of rehabilitation of children with diplegic~     CP.This may reduce morbidity as well as promote better quality of life in these children . In~     this backdrop our study has been planned with an aim to evaluate the efficacy of a~     comprehensive home-centred activity based programme for children with diplegic CP.~   "
88249|NCT02411994|"~     The purpose of this study is to determine the efficacy of pyronaridine-artesunate and~     artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in~     Kenyan children.~   "
88250|NCT02411981|"~     This study will investigate the effects of on technique of chest physiotherapy on pulmonary~     function. Effects of pulmonary function will be measured by the spirometry, body~     plethysmography and by the multiple breath nitrogen washout technique.~   "
88251|NCT02411968|"~     Currently there is no consensus on post procedural follow up imaging following percutaneous~     cryoablation of renal tumors. Interpretation of conventional contrast enhanced imaging (CT~     and MRI) during follow up can be very challenging. The objective of this study is to evaluate~     the feasibility of early evaluation of the therapeutic effect by performing early follow up~     imaging after percutaneous MR-guided cryoablation of pT1a renal cell carcinoma using~     111In-Girentuximab-DOTA SPECT CT imaging.~   "
88252|NCT02411955|"~     The purpose of this study is to evaluate the therapeutic equivalence and safety of Tazarotene~     Cream 0.1% and Tazorac® (tazarotene cream 0.1%).~   "
88253|NCT02411942|"~     The objectives of this study are to evaluate the therapeutic equivalence and safety of~     Adapalene Gel 0.3% and Differin® (adapalene gel 0.3%).~   "
88254|NCT02411929|"~     This study will evaluate the absolute oral bioavailability (F) and fraction absorbed (Fa) of~     ertugliflozin following oral administration of unlabeled ertugliflozin (MK-8835) and~     intravenous (IV) and oral administration of 14^C-labeled ertugliflozin in healthy male~     participants.~   "
88255|NCT02411916|"~     This document defines the Clinical Investigation Protocol for a study designed to determine~     whether blood loss after spontaneous vaginal delivery is altered by the addition of~     misoprostol administration to the standard use of intravenous oxytocin after delivery. The~     protocol is an open-label randomized prospective trial to be carried out at Queens Hospital~     Center.~      Blood loss will be measured indirectly by comparing the maternal hemoglobin and hematocrit~     levels on admission in labor to those obtained within 24 hours after delivery.~   "
88256|NCT02411903|"~     The investigators team had found that the presence of dynamic changes of Clopidogrel~     resistance are not associated with genetic factors. Currently, study on moderate doses of~     statins and dynamic Clopidogrel resistance has not been reported, therefore this study will~     observe 160 cases of open prospective secondary prevention in patients with cerebral~     infarction. Excluded: those patients occurs Clopidogrel resistance because of slow metabolism~     caused by cytochrome P450 isoenzyme 2C19（CYP2C19, and then observed the impact of the~     cytochrome P450 isoenzyme 3A4 （CYP3A4）-metabolized and non-cytochrome P450 isoenzyme 3A4~     （CYP3A4）—metabolized statins dynamically on Clopidogrel resistance in the next 9 months,~     adverse events will be recorded, the metabolite of clopidogrel（H4 ）and the polymorphism of~     cytochrome P450 isoenzyme 2C19 （CYP2C19）/cytochrome P450 isoenzyme 3A4 （CYP3A4）/ cytochrome~     P450 isoenzyme 2C9（CYP2C9）will be detected. Expected Result: the patients use the cytochrome~     P450 isoenzyme 3A4（CYP3A4）-metabolized statins will result in dynamic Clopidogrel resistance~     easily ,H4 levels will decline, and Clopidogrel resistance is not related to the polymorphism~     of cytochrome P450 isoenzyme 3A4 （CYP3A4）.~   "
88257|NCT02411890|"~     The aim of this study is to compare the efficacy in pain relief within 24 hours between~     adductor canal block and femoral nerve block after anterior cruciate ligament reconstruction~     with hamstring graft.~   "
88258|NCT02411877|"~     The purpose of this study is to determine whether reducing a patient's body temperature (mild~     hypothermia of 33 degrees Centigrade) will significantly reduce the risk of brain injury~     (notably reperfusion injury and hemorrhagic conversion) in patients who have suffered a~     significant interruption of blood flow to an area of brain (occlusion of large proximal~     cerebral artery) and have undergone successful removal of that interruption~     (revascularization).This will be achieved by comparing patients who have undergone~     hypothermia to those who have not.~   "
88259|NCT02411864|"~     Our research aims to reveal whether the low b-values distribution and the number of NEX for~     each b value will influence the accuracy of pseudodiffusion parameter derived from IVIM in~     brain.~   "
88260|NCT02411851|"~     Actinic keratoses (AK) are common cutaneous lesions associate with chronic ultraviolet~     radiation exposure. While most authorities consider AK as a pre-malignant lesion, some~     consider it as an incipient squamous cell carcinoma (SCC). Ingenol mebutate is the active~     compound in the sap from Euphorbia peplus L. (E. peplus). Topical ingenol mebutate treatment~     has been approved for the treatment of AKs. Ingenol mebutate gel 0.015% has shown to not only~     have a high clearance rate but also a transient localized inflammatory skin response that~     resolves quickly without sequelae. However, these localized skin responses (eg erythema,~     erosion/ulceration, edema, etc.) can often be unpleasant and unsightly. Currently, there are~     no clinical studies evaluating combination therapies (eg topical steroids, emollients) with~     ingenol mebutate 0.015% that would decrease irritation and improve wound healing while~     maintaining efficacy.~   "
88261|NCT02411838|"~     The investigators hypothesize that adipokine (soluble molecules produced by the adipose~     tissue) levels are altered in MS compared to control subjects. Additionally, the~     investigators hypothesize that calorie restriction (CR) will improve clinical recovery from~     an MS relapse, ameliorate the adipokine and metabolic-inflammatory profile in MS, and enhance~     immune-regulatory mechanisms.~      This is a pilot study to determine the effects of CR in MS patients during an acute MS~     relapse (Acute CR phase) and for 6 months afterwards (Chronic CR phase). Calorie restriction~     will be achieved by following a regimen of alternate day fasting. The investigators will~     evaluate clinical outcomes and blood biomarkers at different time points.~   "
88262|NCT02411825|"~     Primary Objective:~      To assess in healthy adult male subjects:~        -  The tolerability and safety of 21-day repeated subcutaneous (SC) doses of SAR425899~          including two up titration steps.~        -  Pharmacokinetic (PK) parameters of SAR425899 after ascending repeated SC doses in~          plasma.~        -  Pharmacodynamic (PD) effects on fasting and postprandial plasma glucose, insulin,~          biomarkers of lipid metabolism and fibroblast growth factor 21 (FGF21).~      To assess in overweight to obese T2DM mellitus patients:~        -  The tolerability and safety after 28-day repeated SC doses of SAR425899 including 2 up~          titration steps.~        -  PK parameters of SAR425899 after ascending repeated SC doses in plasma and urine.~        -  PD effects on fasting and postprandial plasma glucose, insulin, C-peptide, incretin~          panel (total and active ghrelin, total peptide YY [PYY], total and active glucagon-like~          peptide -1 [GLP-1], glucagon and total gastric inhibitory polypeptide-1 [GIP]), body~          weight, FGF21, biomarkers of lipid metabolism and HbA1c.~   "
88263|NCT02411812|"~     The purpose of this study is to determine if the Herbst appliance with indirect skeletal~     anchorage in mini-implants is capable of preventing excessive inclination of the lower~     incisors at the end of the treatment when compared to the Herbst appliance with dental~     anchorage in patients with Class II malocclusion and overjet ≥ 6 mm.~   "
88264|NCT02411799|"~     Establish a data repository of patients who have undergone thoracic and/or lumbar~     instrumented arthrodesis procedure supplemented by the Implanet Jazz System.~   "
88265|NCT02411786|"~     The purpose of this study is to determine if a vaccine called pTVG-AR can enhance patients'~     immune response against prostate cancer.~   "
88266|NCT02411773|"~     The purpose of this study is to find out why patients with chronic kidney disease (CKD) have~     poor exercise capacity and what causes an increase in blood pressure during exercise (i.e.~     increased adrenaline levels, or decreased ability of blood vessels to dilate).~   "
88267|NCT02411760|"~     In a single MRI exam on a research scanner, each lesion will be categorized using the BI-RADS~     MRI score, which utilizes the DCE data alone, and then again using a modified BI-RADS score,~     which utilizes both DWI and DCE data. The sensitivity and specificity of each approach will~     be determined using pathology as the gold standard.~   "
88278|NCT02411617|"~     Seroma is a common complication following modified radical mastectomy(MRM). Closed drainage~     is used routinely to reduce incidence of seroma. Usually two drains are used in patients who~     underwent MRM to reduce post operative seroma. It is often associated with significant~     patient discomfort and prolonged fluid drainage.~      The aim of this study is to evaluate effect of number of drains on seroma formation rate,~     postoperative pain and hospital stay during the immediate postoperative period after~     mastectomy for breast cancer.~   "
88279|NCT02411604|"~     Open label, multi-center, expanded access study for renal transplant patients with once daily~     Envarsus XR (Tacrolimus).~   "
88268|NCT02411747|"~     Simulation training in surgical education in Urology specialist training in flexible~     cystoscopy has been demonstrated a valid and efficient learning instrument. The classical~     setup with a medical expert introducing the novices to the theoretical background and~     technics of the procedure is time-consuming and expensive. Directed self-regulated simulation~     training (DSR) is a validated method in simulation training. The power of testing in DSR and~     flexible cystoscopy is to our knowledge not known. We introduced a setup in which the novices~     started by training in a directed self-regulated simulation training environment and informed~     them that they would be tested by a medical expert afterwards. The intervention group novices~     were given only written theoretical information and anatomical pictures. The control group~     were first given a classical oral theoretical introduction by a medical expert and secondly~     did DSR training. We tested the outcome of the intervention by a validated rating scale for~     flexible cystoscopy. The novices in both the control and intervention group were tested on~     patients prescribed a flexible cystoscopy and evaluated by a specialist in Urology.~      The main hypothesis was that testing in relation to DSR would result in higher scores on a~     validated scale when performing a flexible cystoscopy on a patient evaluated by a specialist~     in Urology compared to a group having a oral lecture before DSR.~   "
88269|NCT02411734|"~     Executive function will be tested in patients admitted for rehabilitation and correlated with~     rehabilitation success~   "
88270|NCT02411721|"~     Studies have shown that about two thirds of the children undergoing MRI suffer from feelings~     of anxiety ranging from mild apprehension to severe distress. Especially in young children,~     the unfamiliar surroundings, new faces, strange equipment and the noise generated during the~     scan, can cause feelings of stress and anxiety so severe that the test either cannot be~     started or cannot be performed properly due to the child's movements. For older children and~     adults claustrophobia is the main reason of poor image quality because of motion artifacts~     and/or early termination of the scan. Several studies have demonstrated the potential calming~     effects of companion animals on children but, to date, no formal studies on the relationship~     between dog intervention and children's anxiety before MRI procedures have been reported. The~     current study is designed to determine if dog intervention lessens children's anxiety prior~     to MRI~   "
88271|NCT02411708|"~     Safety and effect of SANGUINATE on Sickle Cell Disease patients experiencing a vaso-occlusive~     crisis~   "
88272|NCT02411695|"~     The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of~     oral brexpipirazole in adolescent subjects with schizophrenia or Other Related Psychiatric~     Disorders.~   "
88273|NCT02411682|"~     Reduction of postprandial hyperglycemia (PPHG) is a major target in the treatment of type 2~     diabetes (T2D). Skipping breakfast has been consistently associated with higher HbA1c and~     overall PPHG in subjects with type 2 diabetes (T2D). Our aim was to explore the effect of~     skipping vs eating breakfast on PPHG after subsequent isocaloric (700kcal) lunch and dinner~   "
88274|NCT02411669|"~     A national context for patient centered care development exists in France at hospital with~     strong support for the implementation of operational patient centered care tools. Patient~     centered care is a global vision of patient or family management promoting the respect of~     patient freedom, of patient listening and of patient needs. Patient centered care is an~     important issue of quality and security of care. The FORAP (Fédération des Organismes~     Régionaux et territoriaux pour l'Amélioration des Pratiques et des organisations) and the la~     HAS (High Authority of Health) have developed and validated five tools promoting patient~     centered care at hospital.~      They can be implemented one by one or in association according to hospital situation.~     Hospitals should identify the association of tools fitting the most to their objectives and~     the actions already done.~      The objectives of the project are to analyse the effectiveness of the implementation of HAS -~     FORAP tools on the development of patient centred care at hospital and to analyse the~     individual and organisational determinants of their effectiveness. It focuses on acute care~     hospitals that have the choice of the combination of tools and that are followed during two~     years with combined quantitative and qualitative analyses. Quantitative assessment are based~     on validated indicators on patient satisfaction, patient centred care development and~     organizational context. Qualitative data collection are realised in each included hospital~     and combine individual interviews and focus groups including Physicians, nurses and~     managerial staff.~   "
88275|NCT02411656|"~     You are being asked to take part in this study because you have inflammatory breast cancer~     (IBC) or triple negative breast cancer (TNBC) that is metastatic (has spread to other parts~     of the body).~      The goal of this clinical research study is to learn if pembrolizumab (also called MK-3475~     and Keytruda) can help to control metastatic IBC and TNBC. The safety of this drug will also~     be studied.~      This is an investigational study. Pembrolizumab is FDA approved and commercially available~     for the treatment of metastatic melanoma. Its use in patients with metastatic IBC and TNBC is~     investigational. The study doctor can describe how the study drug is designed to work.~      Up to 35 participants will be enrolled in this study. All will take part in at MD Anderson.~   "
88276|NCT02411643|"~     This study will look into how topical treatment with synthetic Vitamin D3, calcipotriene~     ointment, used as standard of care, works in patients with morphea. Skin biopsies of morphea~     lesions before and after treatment with topical calcipotriene 0.005% ointment will be~     analyzed for changes in RNA and protein. A skin biopsy of unaffected skin will also be~     obtained and used for a control. This is an initial study to look at the molecular effects of~     topical calcipotriene on human morphea-involved skin. This study will look at the differences~     between affected and unaffected skin. This study also will look at clinical outcomes in~     morphea patients and determine if there are any clinical predictors for improvement with the~     medication.~   "
88277|NCT02411630|"~     The purpose of this study is to test a new way to take a questionnaire that asks about~     adherence (whether the person is taking the medicine correctly). This new questionnaire is~     called Interactive Questionnaire System (iQS). In this study, the iQS will be tested on~     HIV-negative young men who have sex with men (YMSM) who are taking PrEP as part of another~     study, either ATN 110 or ATN 113.~   "
88280|NCT02411591|"~     This is medical research evaluating the safety and efficacy of two new medicines (necitumumab~     and abemaciclib), administered in combination in participants affected by a defined type of~     advanced lung cancer (stage IV non-small-cell lung cancer).~   "
88282|NCT02411565|"~     The main purpose of this Pilot Study is to test the safety, tolerability and quality of life~     in women who take Fermented Wheat Germ Extract (FWGE), to determine if an active form of FWGE~     can be detected in the blood, and determine whether short-term therapy with FWGE has any~     effect on the tumor marker, cancer antigen 125 (CA-125).~   "
88283|NCT02411552|"~     This initiative is a prospective study evaluating the effects of implementing physical~     activity strategies in Wisconsin schools with low socioeconomic status on childhood fitness.~   "
88284|NCT02411539|"~     The purpose of this study was to evaluate the safety, tolerability, and effect of an~     experimental human monoclonal antibody (mAb), VRC-HIVMAB060-00-AB (VRC01), in adults infected~     with HIV who were receiving antiretroviral therapy (ART).~   "
88285|NCT02411526|"~     This is an open-label, multiple dose, PK and safety study in patients with chronic, stable~     schizophrenia or schizoaffective disorder.~   "
88286|NCT02411513|"~     The purpose of this study is to investigate the efficacy of e-TNS with the Cefaly® device as~     an acute treatment for a migraine attack. This open clinical trial will study the acute~     treatment of migraine using the Cefaly® device, prior to development of a sham-controlled~     trial.~   "
88287|NCT02411500|"~     The primary objective of this study is to evaluate the pharmacokinetics of various TRV734~     formulations in healthy male subjects.~   "
88288|NCT02411487|"~     To investigate the possible mechanisms by which cataract surgery aggravates meibomian gland~     dysfunction (MGD), the investigators evaluated the changes in tear cytokines and ocular~     surface parameters after cataract surgery according to the preoperative MGD grade.~   "
88289|NCT02411474|"~     Investigate the profiles of tear cytokines in patients who underwent stem cell~     transplantation (SCT) and attempted to determine the applicability of tear cytokines in the~     diagnosis of chronic graft-versus-host disease (GVHD). Evaluate tear cytokines as biomarkers~     of chronic ocular GVHD severity.~   "
88290|NCT02411461|"~     Pseudohypoparathyroidism type 1a (PHP1a) is a rare disease that causes childhood obesity and~     learning difficulties. This study will investigate eating behaviors and perform cognitive~     testing on children with PHP1a. The investigators will compare their results to those of~     healthy siblings and other obese children.~   "
88291|NCT02411448|"~     The main purpose of this study is to evaluate the safety and efficacy of ramucirumab in~     combination with erlotinib as compared to placebo in combination with erlotinib in~     participants with stage IV non small cell lung cancer (NSCLC) harboring an activating~     epidermal growth factor receptor (EGFR) mutation (Del19 and L858R). Safety and tolerability~     of ramucirumab in combination with erlotinib will be assessed in the first portion (Part A)~     before proceeding to the second portion of this study (Part B).~   "
88292|NCT02411435|"~     CAB is an integrase inhibitor that is currently in Phase 2 clinical trials for the treatment~     and prevention of human immunodeficiency virus-1 (HIV-1) infection. RIF, a rifamycin used for~     treatment of tuberculosis (common co-infection in HIV-infected subjects), is a known inducer~     of uridine diphosphate (UDP)-glucuronosyltransferases (UGTs) and Cytochrome P450 3A4~     (CYP3A4). CAB is primarily metabolized via UGT1A1 and UGT1A9, thus a drug interaction between~     CAB and RIF is possible. This study will be a phase I, single-center, open label,~     fixed-sequence cross-over study to compare the single dose PK of CAB oral 30 milligrams (mg)~     when co-administered with RIF 600 mg once daily at steady-state to those of CAB oral 30 mg~     administered alone. Fifteen subjects are planned to be enrolled to obtain 12 evaluable~     subjects for this study.~   "
88293|NCT02411422|"~     The investigators will compare conventional intubation using Macintosh laryngoscope, blind~     endotracheal intubation using i-gel for conduit and bronchoscopic intubation using~     Ambu-aScope and i-gel. All situation assumed as cardiac arrest. i.e, someone give chest~     compressions continuously without interruption.~      Moreover the investigators will compare the type of endotracheal tube. Reinforced tube has~     more soft tube tip, so the investigators think it is more acceptable for intubation using~     i-gel as conduit.~   "
88294|NCT02411409|"~     The CommunityRx system generates patient-centered e-prescriptions for community services~     (HealtheRx) via an interface between the electronic health records (EHR) and a comprehensive~     community resource database. Based on a patient's diagnoses, a HealtheRx will be printed~     automatically at the end of the ambulatory care visit and will provide patients with a~     customized map and/or list of places in their community that provide health and social~     services as well as contact information for a local community health worker who can provide~     limited case management support. The CommunityRx program aims to promote: 1) better~     healthcare, 2) better health, and 3) lower cost. The purpose of this research is to~     systematically evaluate the impact of CommunityRx on health outcomes as well as health care~     service utilization and total cost of care for Medicaid, Medicare and other beneficiaries.~     The investigators hypothesize that beneficiaries who participate in the CommunityRx~     intervention will experience better healthcare, better health and lower total cost of care.~   "
88295|NCT02411396|"~     The Emergency Department has been the standard location where patients with Sickle Cell~     Disease (SCD) go to seek care for the treatment of acute painful events. Vaso- Occlusive~     Crisis (VOC) is the most common complication of SCD,~      The purpose of this study is to compare patient centered outcomes for patients being treated~     for an uncomplicated VOC in Infusion Centers (IC) and Emergency Departments (ED) in four~     locations around the United States.~   "
88296|NCT02411383|"~     This study is a prospective, single-center feasibility study to acquire more knowledge~     regarding the NeuRx DPS and develop a routine in the optimal pacing of the diaphragm with~     this system during the weaning period from mechanical ventilation in the Intensive Care Unit~     in patients after bilateral lung transplant.~   "
88297|NCT02411370|"~     Communication is essential for patients quality of life because it impact on patients care~     quality. Neuromuscular diseases, caracterised by motor damages, hinder non-verbal~     communication of the patient. Therefore, speech must to be functional.~      However, correlation between respiratory failure and voice quality is not very well known.~     The aim of the study is to search a link between respiratory failure and speech impairment in~     patients with neuromuscular diseases.~   "
88320|NCT02411071|"~     Retrospective analysis of HIV-1 positive patients treated with antiretroviral therapy in~     Essen (Germany) from 2004 on. Stored samples from selected patients (n=50) obtained for~     routine diagnostics will be used to analyze the gag gene, the V3-region of the env gene and~     immune cells.~   "
88298|NCT02411357|"~     Nearly 9 of every 10 pregnant opioid-dependent women report that the current pregnancy was~     unintended and the majority of non-pregnant opioid-maintained women do not use contraception~     or use less effective methods like condoms. This proposal aims to further test a novel~     contraceptive management program to increase use of more effective contraceptives among~     opioid-maintained women at risk of unintended pregnancy.~   "
88299|NCT02411344|"~     The purpose of this study is to evaluate the activity of molecular response in endocrine~     sensitive breast cancer HER2+/HR+ patients treated with Pertuzumab-trastuzumab plus~     Ietrozole.~   "
88300|NCT02411331|"~     Implantable venous access port infections are mainly due to coagulase negative staphylococci~     and may be managed by antibiotic lock therapy with retention of the port. Most of the time a~     vancomycin lock is used. Experimental data show that vancomycin may be poorly effective in~     eradicating the staphylococcal biofilm in the port. Another disadvantage of~     Vancomycin-containing lock solution is the occurrence of resistant organisms and the risk of~     catheter occlusion. Ethanol-containing lock solution is highly effective in vitro and does~     not expose to the risk of emergence resistance.~   "
88301|NCT02411318|"~     This study will determine how common lifestyle practices affect the behavior of neutrophils~     (a type of immune cell) at shorter time scales than previously possible.~   "
88302|NCT02411305|"~     Few formal mechanisms for collecting, analyzing, and reporting data on quality in palliative~     care exist. Such infrastructure is needed to understand current clinical practices, inform~     quality improvement projects, and research which links adherence to specific quality measures~     and improved patient-centered outcomes. This infrastructure, if proven feasible, can then~     become integrated into usual palliative care delivery across the PCRC. Then, palliative care~     can conduct the same types of collaborative quality improvement activities, based on data~     collected at point of care, as other medical disciplines like general surgery and cardiology.~   "
88303|NCT02411292|"~     Venous thromboembolism (VTE) is a leading cause of death among hospitalized patients, and is~     an important patient safety issue in plastic surgery. Previous work has shown that enoxaparin~     prophylaxis can prevent many post-operative VTE events, and current American Society of~     Plastic Surgeons guidelines support enoxaparin prophylaxis for high-risk patients. However,~     the Plastic Surgery Foundation-funded Venous Thromboembolism Prevention Study showed that 1~     in 25 highest risk patients still had a breakthrough VTE event despite receipt of~     guideline-compliant enoxaparin prophylaxis. Highest risk patients often have cancer or trauma~     reconstruction. These surgeries may have surgical injury that is equal in scope to patients~     with traumatic or thermal injury. Previous work in patients with traumatic or thermal injury~     has shown that enoxaparin metabolism, measured by anti-factor Xa (aFXa) level, is~     substantially increased: a higher degree of injury is associated with higher enoxaparin dose~     requirements to achieve prophylactic levels. Breakthrough VTE events may occur in plastic~     and reconstructive surgery patients due to inadequate enoxaparin dosing. The investigators~     will examine enoxaparin pharmacokinetics and test whether a clinical protocol for real-time~     enoxaparin dose adjustment can favorably alter the proportion of patients with in-range aFXa~     levels. Primary outcomes include 1) peak and trough steady-state aFXa levels in response to~     standard and escalated doses of enoxaparin and 2) the proportion of patients with appropriate~     aFXa levels pre and post initiation of a clinical protocol for enoxaparin dose adjustment.~     The investigators expect that standard dosing will result in inadequate aFXa peak and trough~     levels, and that the clinical dose adjustment protocol will significantly improve the~     proportion of in-range aFXa levels. The investigators will also develop a linear~     regression-based equation to calculate, based on patient-level factors, the required dose of~     enoxaparin to generate in-range aFXa levels. This research may show that the current one~     size fits all approach to enoxaparin prophylaxis is insufficient. In the trauma and~     orthopaedic populations, patients with low initial aFXa levels are significantly more likely~     to develop deep venous thrombosis. Thus, this study has important implications for~     appropriate enoxaparin dose magnitude and frequency, and may ultimately help to decrease the~     substantial morbidity and mortality associated with post-operative VTE.~   "
88304|NCT02411279|"~     Heart failure (HF) is a serious chronic disease with frequent readmissions, some of which can~     be prevented by early action. The management of HF is complex: long, often difficult and~     costly. In France, nearly one million people suffer from HF and 120,000 new cases are~     diagnosed every year. With the aging population, this number will continue to evolve and~     become a real public health problem. Within 10 to 20 years ahead, WHO projects that heart~     failure in either the 3 most common diseases in industrialized countries.~      The objective of the project is to test an intelligent platform for monitoring at home, using~     non-intrusive sensors, patients with heart failure, particularly those with stage II and III~     NYHA. It will assist the medical automating the processing of information from these sensors~     to detect and report an early stage risk situations.~      Patient monitoring, by a system of telemedicine tools associated with motivation and~     education helps significantly reduce the number of days of hospitalization becomes important~     when the patient is hospitalized for acute HF.~   "
88305|NCT02411266|"~     In remote preconditioning, ischemia in one organ protects distant organs from ischemic~     insults. e.g. brief induced limb ischemia protects the brain from an otherwise more severe~     stroke. The investigators propose a study of limb preconditioning in subjects with~     subarachnoid hemorrhage who are at high risk of cerebral ischemia in the first 2 weeks after~     hemorrhage. The investigators have previously shown that 3x 10min leg conditioning cycles are~     tolerated and appear safe. The investigators are now continuing to assess the safety of the~     intervention by enrolling an additional 60 patients.~   "
88306|NCT02411253|"~     Type 1diabetes (T1D) is caused by autoimmune destruction of the pancreatic islet ß-cells,~     leading to an absolute deficiency in insulin.~      In health, regulatory T cells (Tregs) suppress immune responses against normal tissues, and~     likewise prevent autoimmune diseases. Tregs are insufficient in T1D.~      The investigators previously showed that administration of low doses of IL-2 induces~     selective expansion and activation of Tregs in mice and humans.~      The investigators hypothesize that Tregs expansion and activation with low doses of IL2 could~     block the ongoing autoimmune destruction of insulin producing cells in patients with recently~     diagnosed T1D.~   "
88319|NCT02411084|"~     The objectives of this study are to determine the efficacy and safety of BEGEDINA® in~     subjects with steroid resistant acute graft versus host disease (GvHD). GvHD is a rare and~     complex immunological disease occurring in some recipients of allogeneic hematopoietic stem~     cell transplants (HSCTs) and affecting principally the skin, liver and gastrointestinal (GI)~     tissues. The disease is life threatening and may be acute or chronic and the first choice~     treatment for patients with acute GvHD (Grade II or higher) is the immunosuppressive~     corticosteroid hormone methylprednisolone. However, some GvHD patients may be resistant to~     this treatment leading to disease progression and a high rate of morbidity and mortality,~     primarily from infections and/or multi-organ failure. There are currently no other~     satisfactory therapies. BEGEDINA® is a therapeutic monoclonal antibody that recognises and~     binds to CD26 on CD4+ T lymphocytes. BEGEDINA® reduces the activity of CD26 in these cells~     and inhibits the immune response leading to improvement in patients that have shown steroid~     resistance. This study is therefore aimed at demonstrating that BEGEDINA® is a safe and~     effective treatment for steroid-resistant GvHD patients where no other such treatments are~     currently available.~   "
88307|NCT02411240|"~     Short-term and chronic exposure to ambient levels of particulate matter (PM) is associated~     with increased morbidity and mortality related to respiratory and cardiovascular disease.~     Proposed biological pathways imply that particle-induced inflammation plays a role in~     activating the vascular endothelium and altering vascular function. Accumulating evidence~     suggests that outdoor air pollution has a significant impact on central nervous system health~     and disease and living in conditions with elevated air pollution has been linked to decreased~     cognitive function.~      Only recently was shown that reductions in ambient levels of PM2.5 were associated with~     improvements in life expectancy. However, studies of the beneficial effects of improved~     indoor air quality on healthy humans are lacking.~      With this project the investigators intend to study the effects of rooms with clean air in~     the elderly with the emphasis on cardiovascular and cognitive function. The investigators~     hypothesise that by means of air cleaning, controlled and reduced exposure has a positive~     effect on cardiovascular parameters such as blood pressure, heart rate variability, macro-~     and microcirculation and on neurobehavioral function. The investigators substantiate these~     outcomes with potential mechanisms of action at the transcript and epigenetic level as with~     hematological parameters, markers of inflammation, lipid and protein oxidation products and~     mitochondrial DNA damage. To achieve these goals there is a specific need to study the~     elderly, as they appear to have elevated susceptibility and have the largest attributable~     risk related to indoor PM, as they spend more time indoors. Suited concepts for study~     location are elderly homes (service flats) and retirement homes.~      The ELiFA-cohort stands for Elderly Living in Filtered Air consisting of an intervention~     study during 2-week periods of a pre-purification (baseline), active purification and a post~     purification period.~   "
88308|NCT02411227|"~     Background:~      - People with traumatic brain injury (TBI) can have problems with thinking and everyday~     activities. They may have a higher risk for car accidents. NeuroDRIVE uses a virtual reality~     driving simulator. Researchers think it can help test and improve how people think and drive~     after TBI.~      Objective:~      - To test how NeuroDRIVE affects brain performance and driving safety.~      Eligibility:~      - People at least 18 years old with a history of TBI and who had a driver s license at some~     point. They must speak, read, and write English and be physically able to drive.~      Design:~        -  Participants will be asked to release their driving records, but they do not have to do~          this to be in the study.~        -  Visit 1: Screening physical exam.~        -  Visit 2: Magnetic resonance imaging (MRI) scan. Participants will lie on a table that~          slides into a cylinder with a strong magnetic field. A device will be placed over the~          head. Participants may do computer tasks during the scan.~        -  Participants will have tests of memory, attention, and thinking. They may be asked~          questions, take tests, and do simple actions.~        -  Visit 3: Tests of memory, attention, and thinking, plus a virtual reality driving~          assessment.~        -  Participants will be assigned to Group 1 to start NeuroDRIVE training immediately or~          Group 2 to start 10 weeks later.~        -  Visits 4 9, over 4 weeks:~        -  Participants will practice driving skills and mental exercises in the simulator.~        -  They will complete a driving questionnaire online each week.~        -  Visit 10: Repeat of Visit 3, with some small changes.~        -  Visits 11-12: Very similar to Visits 1-2. Includes MRI scan; physical exam;~          questionnaires; and tests of thinking, memory, and attention..~        -  After Visit 12: Participants will fill out a weekly driving survey online for 4 weeks.~   "
88309|NCT02411214|"~     The survey analyses how to improve the decision-making process for fertility preservation in~     the pediatric population based on~        1. patient and parent feelings about fertility preservation counselling~        2. influence of the emotional state of patients and parents on fertility preservation~          acceptance~        3. support of medical staff and family The study revealed that attention to the fertility~          preservation pathways was important for the satisfaction of patient's and parent's~          expectations~   "
88310|NCT02411201|"~     The main purpose of the study is to evaluate the pharmacokinetics of DOTAREM® in the body of~     children aged less than 2 years thanks to several blood samples (3 ml in total) taken~     following the administration of DOTAREM®.~      DOTAREM® is a contrast agent commonly used for enhancement of Magnetic Resonance Imaging~     (MRI) to potentially improve the quality of the images and help the diagnosis. Children aged~     less than 2 years scheduled to undergo routine gadolinium-enhanced MRI of any body region may~     take part in the study. In this case they will receive DOTAREM®, a solution injected at the~     standard dose of 0.2mL/kg (0.1 mmol/kg) of body weight.~   "
88311|NCT02411188|"~     The goal of the proposed project is to determine if providing an intervention for women who~     decline the invitation to participate in standard cardiac rehabilitation programs (CRPs) will~     ultimately result in an increase their participation in CRPs.This study will evaluate~     outcomes of patients randomized to the FHHS STEP Program versus by non-STEP Program~     participants. The overall goal is to provide an alternate, introductory program that will~     engage, educate, and empower women following a cardiac event. Providing these women with the~     necessary personal resources will encourage and enable these women to take the step towards a~     cardiac rehabilitation program, which, in turn will ideally lead to a life-long commitment to~     heart health.~   "
88312|NCT02411175|"~     Constipation is an umbrella term encompassing either infrequent bowel movements, difficult~     evacuation of stool, hard stool or a sensation of incomplete defecation. It affects 10-15% of~     the global population. Constipation may negatively impact physical health, moods and social~     life. There exists a 50% dissatisfaction with traditional approach of laxative use.~     Conventional laxatives only offer a temporary solution and may cause dependency. Side-effects~     of conventional laxatives include nausea, vomiting, flatulence, diarrhoea, abdominal pain,~     electrolyte imbalance and skin eruptions. Homeopathy is a potential treatment option for~     constipation, however further research is needed in this regard.~      The aim of this study is to determine the efficacy of individualised homeopathic treatment on~     constipation using case studies, an adapted Bowel Function Diary and the Bristol Stool Form~     Scale.~   "
88313|NCT02411162|"~     This will be an open-label, non-randomized, single-center study to assess the residency of~     GSK2894512 in the skin of healthy adult male volunteers with normal barrier function. The~     study will have two parts, Cohort 1 (Part A) followed by Cohort 2 (Part B). The study will~     assess the residence time in human skin . The primary objective is to evaluate the residency~     time in skin following topical application of two formulations of GSK2894512 Cream. The total~     study duration will be of 15 days including 1 to 7 days of treatment period, 8 to 14 days of~     post treatment period and 1 day of follow up. The screening period will be up to 28 days~     prior to Baseline (Day 1).~   "
88314|NCT02411149|"~     This study aims to compare the functional recovery of patients undergoing Total Knee~     Arthroplasty based on the administration of an adductor canal block during their anesthesia~     treatment~   "
88315|NCT02411136|"~     This study is to evaluate the safety of AMG 623 in subjects with systemic lupus~     erythematosus. All subjects will receive 4 weekly doses of study drug over a 3 week period,~     and then will be followed for an additional 28 weeks, for total study duration of 31 weeks.~   "
88316|NCT02411123|"~     The purpose of this study is to evaluate the effect of pharmacogenetic (PGx) testing on~     clinical outcomes in a group of subjects exhibiting neuropsychiatric disorders, such as~     depression and anxiety, as compared to a group of subjects with the same attributes without~     the guidance of PGx testing for their treatment.~      This study will also evaluate whether pharmacogenetic (PGx) testing can reduce adverse drug~     events, hospitalization rates, hospital length of stay, emergency room visits, disability,~     death or other serious drug side effects.~   "
88321|NCT02411058|"~     In this experiment, the investigators will test the effectiveness of a two week 20x incentive~     multiplier on the investigators' corporate partner's users who are (a) not notified about the~     incentives in advance, and (b) notified about the incentives and their purpose. The~     investigators will test which group shows the largest boost in walking during the two week~     intervention and the most lasting behavior change.~   "
88322|NCT02411045|"~     In this study, the investigators ask the question: can incentivizing smaller, less costly~     behaviors—like just getting yourself dressed to go to the gym—be more effective (and~     palatable) than incentivizing the larger goal directly?~   "
88323|NCT02411032|"~     The investigators are proposing an experiment to help Humana investigate when to launch~     programs or send messages that are designed to improve customers' engagement. The~     investigators' past research has shown that certain life events and calendar events (e.g., a~     job change, a birthday, a holiday, Monday) feel like a fresh start to people and have the~     potential to motivate them to begin pursuing their health goals (e.g., exercising, starting a~     diet, quitting smoking).~   "
88324|NCT02411019|"~     This study is to follow up on the change of immune response by measuring HPV type 16/18 E6~     and E7 specific T cell response and lesion condition in subjects who have administered in~     DNA-based therapeutic vaccine.~   "
88325|NCT02411006|"~     The investigators seek to increase medication adherence of subjects. The investigators will~     send mailings to customers of an insurance company, asking them to predict or commit to a~     certain level of behavior. The investigators will measure whether this increases medication~     adherence.~   "
88326|NCT02410993|"~     According to 2011 ACCF/AHA guideline and 2014 ESC/EACTS guideline, CABG surgery was~     recommended for three-vessel coronary artery disease and left main coronary artery disease in~     the patients with stable ischemic heart disease as class I. 2-VD with proximal left anterior~     descending artery stenosis was also indicated for CABG surgery as class I recommendation.~     However, many patients have been recommended for PCI by catheterization laboratory~     cardiologist; 46% and 93% in the only-CABG candidates and both CABG and PCI candidates,~     retrospectively, defined by previous ACC/AHA guideline. Although the discordance between real~     practice in catheterization laboratory and guideline would be adjusted by recently updated~     guideline. The revascularization strategy for patients with 3-VD/LMD in real practice have~     been getting toward more PCI and less CABG surgery. In this study, we will identify the rate~     of CABG candidates who were treated with PCI or medical treatment instead of CABG surgery in~     different from current guideline. We are also going to compare two treatment strategies CABG~     surgery vs. PCI with 2nd generation DES regarding clinical outcomes.~   "
88327|NCT02410980|"~     The researchers will assess the effects of treatment with tretinoin cream on human skin by~     using non-invasive optical imaging technologies.~   "
88328|NCT02410967|"~     This study is a pilot test of Attention Bias Modification Training (ABMT) among clinic~     referred children and adolescents with subthreshold impairing anxiety (i.e., anxiety and~     related impairment that fails to meet criteria for an anxiety disorder diagnosis). Half of~     participants will receive 8 sessions of computer administered ABMT and the other half of~     participants will receive a 8 sessions of a computer administered control task.~   "
88329|NCT02410954|"~     Locus coeruleus (LC) norepinephrine (NE) neuron activity has been convincingly linked to~     regulation of acute fear. This study will address whether LC NE activity examined through~     pupil measures will reflect carbon dioxide (CO2) induced fear-responses in humans and if~     transcranial direct current stimulation (tDCS) can mitigate these effects. A 2 year R21 phase~     establishing feasibility, tolerability, safety, and proof-of-concept (POC) in terms of~     capacity to engage LC NE neurons with tDCS, followed by a 3 year R33 parallel-group,~     double-blind, randomized, controlled trial will determine the degree to which engaging LC NE~     neurons with tDCS improves clinical symptoms.~   "
88330|NCT02410941|"~     Utilization of diagnostic imaging in the Emergency Department has increased dramatically over~     the past two decades, driven by an increased availability of advanced imaging, legal~     pressures to exclude serious diagnoses in low-risk patients, patient expectations, and the~     tendency to associate more testing with a higher quality of care. However, this rise in the~     use of diagnostic imaging, particularly in low-risk patients, may not be taking into account~     the risk of radiation exposure to patients, or the impact on finite health system resources.~     The objective of this project is to improve the appropriateness of CT imaging in Alberta~     Emergency Departments by advancing awareness of, and adherence to, evidence-based guidelines~     for CT imaging of patients with mild traumatic brain injury (MTBI) and suspected pulmonary~     embolism (PE). These two clinical scenarios have been selected because of evidence of~     significant variation in imaging practices across Alberta, and the robust evidence base that~     exists to guide CT imaging decisions such as the Canadian CT Head Rule and the Pulmonary~     Embolism Rule Out Criteria.~   "
88331|NCT02410928|"~     Recurrent nerve palsy is a complication of thyroidectomy. Most surgeons want to visualize the~     vocal cords after tyroidectomy. The aim is to compare the direct laringoscopy,~     videolaringoscopy, fiberoptic laringoscopy and ultrasonography methods in terms of efficacy,~     duration and hemodynamic responses during the procedure.~   "
88332|NCT02410915|"~     Overall aim is to evaluate HAL for gait training early after stroke and the effect of HAL on~     short- and long-term functioning, disability and health compared to conventional gait~     training as part of an inpatient rehabilitation program early after stroke.~   "
88333|NCT02410902|"~     The purpose of this study is to determine whether CM-AT is safe and effective in treating the~     core symptoms of autism in children with all levels of fecal chymotrypsin.~   "
88352|NCT02410655|"~     The purpose of this study will be to evaluate a standardized, evidence-based protocol versus~     a conventional approach for the dosing of oxytocin in vaginal delivery.~   "
88353|NCT02410642|"~     NAG is a protein excreted in urine in cases of tubular damage, and is considered a biomarker~     of kidney injury. Elevated urinary NAG is seen after cardiac surgery, but the clinical~     significance, pattern of excretion and links to perioperative factors are poorly described.~     We plan a study of the pattern of NAG-excretion during cardiac surgery with cardiopulmonary~     bypass, and explore possible associated variables.~   "
88892|NCT02403583|"~     The purpose of the study is to develop and pilot-test a home-based intervention to facilitate~     sate HIV testing and disclosure within pregnant couples in order to increase use of~     prevention-of-mother-to-child-transmission (PMTCT) and family health services in Kenya.~   "
88334|NCT02410889|"~     The purpose of this project is to develop the method of combined recording of~     electroencephalography (EEG) and functional magnetic resonance imaging (fMRI) in order to~     improve understanding of the relationship between electrical (EEG) and blood flow (fMRI)~     responses to epileptic discharges as a necessary step towards clinical use. One factor that~     currently limits the use of EEG−fMRI in patients with epilepsy is that a relatively large~     proportion of patients do not show any fMRI response despite epileptic activity having been~     detected on the EEG recorded during scanning. The reasons for this are unclear, which makes~     it difficult to predict in advance whether useful information will be gained from the~     scanning session. What is it about some epileptic discharges that results in a detectable~     change in the fMRI signal, while others which are no less obvious or frequent do not? This~     question will be addressed by determining the factors that are responsible for the occurrence~     of robust fMRI signal changes via detailed morphological, topographical and spectral analysis~     of the EEG signal on an event by event basis.~   "
88335|NCT02410876|"~     Patients with obstructive or neurogenic lower urinary tract disease will be invited to~     participate. Upon agreement they will undergo an assessment of bladder function~     (questionnaires) and bladder biopsies at 2 time-points. Bladder biopsies will be evaluated~     for molecular changes in the laboratory and compared to the functional findings.By uncovering~     the molecular similarities and differences between BLUTD and NLUTD, the investigators will~     elucidate some of the causative factors in the development of these disorders and highlight~     the impact of myogenic and neurogenic components postulated to be involved. The project~     involves close collaboration between clinical and basic research.~   "
88336|NCT02410863|"~     This is an open-label, multi-center, clinical phase II study to explore the correlation of~     the genetic make-up of the treated tumor before start of therapy and to correlate clinical~     response at 8 weeks as well as metabolic response at 2 and 8 weeks with genetic features of~     the tumor.~      It will be conducted as a rationale optimization of targeted therapy in BRAF naïve and~     pretreated patients.~      Prerequisite for all patients is the availability of tumor sample at start of treatment in~     order to determine the underlying driver mutation (BRAF mutational status) as well as~     molecular composition by next generation sequencing (NGS) and assessable lesions for biopsy~     at week 2. Melanoma patients in stage III (non-resectable) and stage IV are sorted into~     Cohort A or B according to their previous BRAF-treatment and treated with dabrafenib and~     trametinib (cohort A and B)~   "
88337|NCT02410850|"~     Obstructive sleep apnea (OSA) is a highly prevalent breathing problem that occurs during~     sleep. OSA have been associated with the obesity epidemic in developing countries;~     additionally, high OSA prevalence rates are present in populations with cardiovascular and~     metabolic disorders. Two OSA treatments are currently available, oral appliance (OA) therapy~     and continuous positive airway pressure (CPAP). OAs are an underutilized non-surgical~     treatment and few studies have analyzed their long-term effectiveness for patients with OSA.~     The purpose of this study is to assess the long-term effectiveness of OA therapy in patients~     with OSA and to explore any changes on cardiovascular related morbidity and mortality related~     to this therapy.~   "
88338|NCT02410837|"~     The purpose of this study is to evaluate outcomes following electromagnetic navigation~     bronchoscopy™ (ENB™) procedures using the superDimension™ navigation system.~   "
88339|NCT02410824|"~     Bilateral dispensing clinical trial of stenfilcon A against etafilcon A for astigmatism.~   "
88340|NCT02410811|"~     The purpose of this study is to use cardiac magnetic resonance imaging (CMR) and~     echocardiographic tissue Doppler imaging to demonstrate a unique restrictive cardiomyopathy~     of sickle cell disease. The investigators will characterize its frequency and how it might~     change (e.g., presence/absence and severity) over a 2-year period.~   "
88341|NCT02410798|"~     The overall goal of this feasibility study is to advance the development of NeuRx DPS for the~     intended use of stimulating the diaphragm to provide respiratory assistance in patients at~     risk of prolonged mechanical ventilation in the ICU. This is the first step to determine the~     technical feasibility of the short-term TransLoc DPS electrode in humans.~   "
88342|NCT02410785|"~     The polyglucosamine, specification L112 is a medical device and in this clinical trial used~     for weight reduction of overweight and obese participants. The rationale for this study is to~     show that overweight can be reduced by taking 2 times daily 2 tablets with the main meals~     with the highest fat content.~   "
88343|NCT02410772|"~     The purpose of this study is to determine whether one or two four-month regimens of~     tuberculosis treatment are as effective as a standard six-month regimen for treatment of~     pulmonary tuberculosis (TB). All three regimens are administered daily, seven days each week,~     with direct observation of each dose by a health-care worker at least five of the seven days~     of each week.~      The standard six-month regimen is two months of isoniazid, rifampin, ethambutol, and~     pyrazinamide followed by four months of isoniazid and rifampin.~      The first short regimen is a single substitution of rifapentine for rifampin: two months of~     isoniazid, rifapentine, ethambutol, and pyrazinamide, followed by two months of isoniazid and~     rifapentine.~      The second short regimen is a double substitution of rifapentine for rifampin and~     moxifloxacin for ethambutol: two months of isoniazid, rifapentine, moxifloxacin, and~     pyrazinamide, followed by two months of isoniazid, rifapentine, and moxifloxacin.~      Target enrollment is 2500 participants. Each study participant will remain in the study for~     18 months in order to include at least 12 months of evaluation of whether the participant's~     TB recurs.~   "
88344|NCT02410759|"~     200 women will be randomly divided into 2 equal groups using computer generated random~     numbers. Group 1 will receive Carbetocin 100 µgm (Pabal® Ferring, UK) and group 2 will~     receive ergometrine 0.5mg (methergin®, Novartis, Switzerland).~   "
88354|NCT02410629|"~     The investigators are trying to determine the therapeutic effect of the music glove and~     conventional hand exercise program to the subacute stroke patients. All participants will be~     randomized into two groups: AB and BA. They will all exercise at least 3 times a week for 3~     weeks with a minimal 3 hours exercise time per week. Participants will receive the other~     intervention at 3-month post stroke date. Clinical evaluations will be performed at baseline,~     post therapy after first intervention, 3-week post intervention follow up, 3-month post~     stroke, post therapy after second intervention, 3-week post second intervention follow up,~     and 6-month post stroke follow up visits.~   "
88345|NCT02410746|"~     Effective postoperative pain control is an essential component of surgery. Adequate analgesia~     improves patient comfort and satisfaction, thereby permitting earlier mobilisation, faster~     recovery and less likelihood of complications.The majority of surgeons will place 10ml of~     local anaesthetic into the breast pocket or inject it into the breast skin following breast~     surgery. A more specific technique is to identify the nerves supplying the breast and put the~     local anaesthetic directly around them (Pec block). This nerve block has recently been~     described and is increasingly being used by anaesthetists for surgery under local anaesthetic~     or for post-operative analgesia. It has been shown to provide better and more specific pain~     relief in several studies.~      Anaesthetists use an ultrasound machine to identify the anatomical landmarks for the nerves~     and they inject into the vicinity. They do not have direct vision and there is a risk of~     causing morbidity or the block not being effective. It is much easier for a surgeon to apply~     the block, as they can see the anatomical landmarks. Despite this, very few surgeons are~     aware of the technique.~      The study group consists of patients undergoing bilateral cosmetic breast surgery at BMI~     Edgbaston and Priory hospitals and Spire Parkway and Southbank hospitals in Birmingham and~     Worcester. If a patient consents to being involved in the research, they will have one breast~     randomised to receiving a pec block and the contralateral (opposite) breast will receive the~     same amount of local anaesthetic placed in the breast pocket in a non-targeted fashion. The~     patients and researcher will be blinded as to the allocation. Patients will complete a verbal~     numeric pain score for each breast at set intervals until they are discharged.In addition,~     the investigators will specifically ask which breast is the most painful at each time point.~      The results of the study may improve patient care.~   "
88346|NCT02410733|"~     The purpose of this study is to determine the safety and tolerability of intravenous~     administration of a tetravalent RNA-lipoplex cancer vaccine targeting four tumor-associated~     antigens in patients with advanced melanoma.~   "
88347|NCT02410720|"~     Colonoscopy is the preferred procedure to investigate any large-bowel disease in adults and~     children. In addition, colonoscopy is the current gold standard for colorectal cancer~     screening due to its high diagnostic capabilities and its unique feature that permits~     sampling and removal of pathology. For optimal performance and visualization of details,~     however, an adequate bowel preparation is essential. Inadequate bowel preparation is~     associated with cancelled procedures, prolonged procedure time, incomplete examination,~     increased cost and possibly complications, physician frustration and patient anxiety, but~     most importantly serving to impede colorectal cancer screening and surveillance.~      A good bowel preparation would need a solution with a reasonable volume, acceptable taste,~     minimal diet restrictions, and easy to follow instructions; and would also need patients'~     adherence to the instructions and diet restrictions. Noncompliance of patients to the diet~     restrictions, the starting day of diet, the timing of drinking the solution, and other~     instructions play an important role in rendering the colon preparation inadequate.~      Aim: The investigators aim, at assessing the influence of having a reminder mobile~     application on the compliance and adherence to instructions and diet and consequently on the~     quality of colon preparation.~      Hypothesis: The investigators' hypothesis is that patients having a customized mobile App~     reminding them systematically about instruction and time of intake of the preparation will~     have a better adherence to the prep protocol and likely on the quality preparation than those~     given written and verbal instructions in clinic.~   "
88348|NCT02410707|"~     The purpose of this study is to describe the safety and efficacy of nitrous oxide~     administration for pain and anxiety before propofol in patients requiring any procedure under~     sedation in the Emergency Department. Procedural sedation is the use of sedative, analgesic,~     and/or dissociative agents to relieve anxiety and pain associated with diagnostic and~     therapeutic procedures. Propofol is commonly used and is a sedative and amnestic, but~     provides no analgesia. Short acting opioids may be used for pain relief, but come with the~     risk of respiratory depression. An optimum analgesic to relieve pain in patients who need~     procedural sedation should be short acting, easy to administer and safe. Nitrous oxide may be~     a suitable agent, but literature supporting or rejecting its use in adults is lacking. This~     study aims to fill this gap. Adult patients capable of consenting, coming to the Emergency~     Department with painful condition requiring procedural sedation are the targeted population.~     Eligible patients who consent to the study will receive Nitrous Oxide gas delivered through a~     hand held mask before they receive propofol for the procedure. Information regarding their~     vitals, pain scores and medical condition will also be collected.~   "
88349|NCT02410694|"~     Overview of Study Design:~      This is an open phase II, single-arm, multi-center study to evaluate progression free~     survival in patients receiving ixazomib in combination with thalidomide and dexamethasone~     (ITD) followed by an ixazomib maintenance phase of a maximum period of 12 months.~      The patient population will consist of adult male and female patients with multiple myeloma~     (MM) with relapsed and/or refractory disease after at least one prior treatment line.~      In case of enrollment patients will receive ixazomib 4.0mg at days 1, 8, 15, thalidomide~     100mg at days 1 to 28 (50mg in patients aged ≥75 years), and dexamethasone 40mg (20mg in~     patients aged ≥75 years) at days 1, 8, 15 of a 28-day treatment cycle. The proposed number of~     cycles is 8. Treatment will be discontinued in case of progressive disease or in case of no~     response after 4 cycles (≤ SD after 4 cycles). After discontinuation of therapy an end of~     treatment visit (EOT) will be performed within 14 days after the last dose of the last~     combination treatment cycle.~      After 8 cycles of ITD therapy, maintenance treatment with 4.0mg ixazomib (3.0mg in patients~     aged ≥ 75 years at first day of maintenance phase) on days 1, 8, 15 of 28-day cycles will be~     administered to patients with ≥ MR for a maximum period of 12 months. Patients who completed~     less than 8 cycles of ITD treatment do not qualify for maintenance phase.~      Follow-up visits will be performed in 3-monthly intervals until the last patient on ixazomib~     maintenance therapy has concluded or discontinued the maintenance phase.~      A safety analysis will be conducted after enrollment of the first 6 patients and completion~     of at least two cycles in every patient.~   "
88350|NCT02410681|"~     Excessive mechanical forces can cause complications of dental implants and their~     suprastructures (crowns and bridges), and can possibly be destructive for the bone and soft~     tissues around the implants. Sleep bruxism (grinding and clenching of the teeth during sleep)~     is considered as an important source of mechanical forces in the oral environment. Therefore,~     in this study, the investigators will investigate whether sleep bruxism is associated with~     implant and peri-implant complications.~   "
88351|NCT02410668|"~     To study the effects of Flaxseed supplement on weight, lipid profile and inflammatory factors~     in subjects with over weight and obesity, 50 patients will be randomly allocated to receive~     placebo or 30 grams milled Flaxseed for 12 weeks; both groups will be advised to adherence~     the investigators' diet and exercise program too. At the first and the end of the~     intervention, weight, waist and hip circumference, lipid profile and some inflammatory~     markers will be assessed and compared between groups.~   "
88357|NCT02410590|"~     The primary objective of this trial is to compare the preference between two strategies of~     neuromuscular blocking (NMB) / reversal in adult obese patients undergoing laparoscopic~     abdominal surgery: Rocuronium + Sugammadex versus Succinylcholine + Cisatracurium +~     Neostigmine/Atropine. This will be done evaluating the average verbal numerical scale (VNS)~     scores obtained from surgeons blinded to the drugs administered. The primary hypothesis is~     that the strategy Rocuronium + Sugammadex provides a better surgical visual field in obese~     participants undergoing laparoscopic abdominal surgery than the strategy Succinylcholine +~     Cisatracurium + Neostigmine/Atropine as measured by VNS scores.~   "
88358|NCT02410577|"~     The purpose of this study is to test a new imaging agent called 89Zr-J591 (stands for~     humanized antibody called J591, that is attached to a radioactive material called~     Zirconium-89) in patients with glioblastoma multiforme.~   "
88359|NCT02410564|"~     To determine the efficacy of a CBT-I intervention in improving sleep and other quality of~     life outcomes during cancer treatment. To assess the feasibility and acceptability of a CBT-I~     intervention among newly diagnosed cancer patients.~   "
88360|NCT02410551|"~     The goal of this clinical research study is to learn if giving pacritinib before standard of~     care drugs followed by an allogeneic stem cell transplant can help to control~     myeloproliferative neoplasms. The safety of this therapy will also be studied.~   "
88361|NCT02410538|"~     The intervention consists of the delivery of a list of 21 questions to the relative of each~     patient admitted in ICU, intubated and mechanically ventilated during the first 48 hours of~     the stay. A formal interview is scheduled for relatives at Day 3 of inclusion. The~     information comprehension at Day 5 (± 1) will be compared between families that received the~     list of FAQ and families that received information as usual (without providing the list of~     FAQ~   "
88362|NCT02410525|"~     In this study, radioactive PF-06427878 will be administered, through a vein, alone and with 2~     different oral doses of non-radioactive PF-06427878 to healthy, adult, male subjects.~     Positron emission tomography will be used to characterize tissue distribution. The study will~     also characterize how the study drug behaves in the body, its safety, and how the body~     tolerates it.~   "
88363|NCT02410512|"~     This Phase Ib, open-label, dose-escalation study will evaluate the safety, tolerability, and~     pharmacokinetics of the combination of MOXR0916 and atezolizumab in participants with locally~     advanced, recurrent, or metastatic incurable solid malignancy that has progressed after~     available standard therapy; or for which standard therapy has proven to be ineffective or~     intolerable or is considered inappropriate; or for which a clinical trial of an~     investigational agent is a recognized standard of care. Participants will be enrolled in two~     stages: a dose-escalation stage and an expansion stage.~   "
88364|NCT02410499|"~     The purpose of this study is to characterize the effects of 85 days treatment with MLN1202 on~     urinary albumin-to-creatinine ratio (UACR) in participants with type 2 diabetes, advanced~     kidney disease/diabetic nephropathy (DN) and macro-albuminuria (UACR>300 mg/g) based on~     average of 3 consecutive first morning voids sample collection.~   "
88365|NCT02410486|"~     This prospective surveillance study will be conducted over a 2 year period to determine~     current rates of Early-Onset Sepsis (EOS)/ Early-Onset Meningitis (EOM), associated~     pathogens, antimicrobial resistance, signs and symptoms and infant outcomes.~   "
88366|NCT02410473|"~     Neonates, children with single ventricle congenital heart disease, and those undergoing~     multiple complex cardiac surgeries are at high risk of increased perioperative blood loss,~     and blood product transfusions. In addition, some of these patients will present an increased~     risk of postoperative thromboembolic complications. For a long time, bleeding management has~     been based on the empiric administration of different blood products (e.g. platelet~     concentrates, cryoprecipitates, and/or activated factor VII), topical hemostatic agents, and~     surgical manipulation. Recently, the use of viscoelastic tests (e.g. thromboelastography~     (TEG) or thromboelastometry (ROTEM)) increased, and allowed a better assessment of~     perioperative coagulopathy, and a more 'rational' treatment of bleeding. While TEG and ROTEM~     record the viscoelastic properties of whole blood by measuring mechanical impedance and~     related changes during clot formation, T2MR, a miniaturized, magnetic resonance-based~     diagnostic platform, measures how water molecules react in the presence of magnetic fields to~     evaluate a broad range of hemostasis measurements. In this study, we will prospectively~     collect demographic data, surgical characteristics, the amount of perioperative bleeding and~     blood product transfusion, results of laboratory assays, and postoperative outcomes (30-day~     follow-up or until discharge), with the aim to assess our current practice, and develop an~     algorithm-based approach for the administration of targeted blood product and pro-coagulant~     therapies. Our goals are: the reduction of blood product utilization, the reduction of the~     incidence of massive bleeding and postoperative thrombosis.~   "
88367|NCT02410460|"~     This study is a prospective, double-blind, randomized comparison study of different~     anesthesia methods in rhytidoplasty surgery. The study is designed to determine whether~     post-operative side-effect profiles in patients undergoing elective cosmetic facelift surgery~     can be decreased through the use of propofol/ketamine anesthesia with bispectral monitoring~     (PKA-BIS) rather than general anesthesia, without increasing intra-operative time,~     side-effect profiles, or patient recall. Approximately 30 subjects undergoing facelift~     surgery performed by the principal investigator will participate.~   "
88368|NCT02410447|"~     Chronic soft tissue wounds of the lower limbs are painful and debilitating condition that~     significantly reduce the quality of life of the patient. They often do not respond to~     conservative treatments or advanced wound managements. Focused and defocused extracorporeal~     shock wave therapy can be a viable alternative therapeutic strategy.~      The purpose of the study was to examine the effects of defocused extracorporeal shock wave~     treatment on chronic soft tissue wounds of the lower limbs, in terms of the rate of wound~     healing and pain control.~   "
88369|NCT02410434|"~     The specific objectives of this study are reduce stigma towards lesbian, gay, bisexual, and~     transgender persons in Swaziland and Lesotho, using performance ethnography at community~     roundtables.~   "
88426|NCT02409693|"~     This is a retrospective chart review. The purpose of this study is to retrospectively examine~     the use of perioperative analgesics on the incidence of postoperative pain and emergence~     delirium in patients undergoing bilateral myringotomy with tube insertion (BTI), as well as~     events associated with treatment including postoperative vomiting and time to discharge.~   "
88370|NCT02410421|"~     Although repetitive trans-cranial magnetic stimulation (rTMS) is an effective therapy for~     resistant depression, it still fail to remit up to 70% of these patients. We hypothesize that~     personalizing the procedure using functional MRI to better select dysfunctional regions and~     robotic coil placement to stimulate these regions homogeneously, will increase its efficacy.~     Individualized rTMS will be compared to traditional rTMS procedure and to trans-cranial~     direct current stimulation (tDCS).~      In this small proof of principle study our primary outcome measure will be the correction of~     the MRI anomalies. Symptoms reduction and the proportion of remitters will be secondary~     outcome measurements.~   "
88371|NCT02410408|"~     Adverse events are also the cause of suffering in health professionals involved (second~     victims). This study has the aim of design and evaluates two applications for staff of~     hospital and primary care settings with the intention of improving their capacity to conduct~     Root Cause Analysis (RCA) and to help them introducing patient safety certification (PSC).~      A single-blind randomized controlled trial shall conduct with a control and an experimental~     group (N=84) in both cases. The characteristics of both apps shall specify based on the~     suggestions of health professionals and shall design for Android and IOS (for iPhone or~     Ipad).~      The randomly subjects in the control group shall receive oral and written information and the~     experimental group used App for two months. Pre- and post- measures shall include: patient~     safety knowledge and culture and self-perceived capacity to enhance RCA or follow-up PSC. In~     the experimental group, data shall also collect on their previous experience with information~     and communication technologies, their rating of each App. The inter-group intervention~     effects shall calculate by univariate linear models and ANOVA, with the pre- to~     post-intervention differences as the dependent variables.~   "
88372|NCT02410395|"~     The aim of this trial was to compare two different uterotomy surgical techniques on the~     occurrence of a uterine niche and the risk of a number of short- and long-term gynecological~     complications associated with the presence and size of the niche.~   "
88373|NCT02410382|"~     This study will look at how dexamethasone and placebo influence radiation fatigue, quality of~     life and number of treatment days missed during radiation therapy or radiation therapy and~     chemotherapy for cancer.~   "
88374|NCT02410369|"~     In this clinical study, the investigators evaluate the efficacy and safety of S-588410 in~     patients who underwent an adjuvant chemotherapy after the complete resection of~     non-small-cell lung cancer.~   "
88375|NCT02410356|"~     This study assesses the safety and tolerability of weekly TV-1106 compared to daily rhGH in~     adults with GHD who have previously been treated with rhGH.~   "
88376|NCT02410343|"~     The primary objective of this study is to determine the efficacy of 6 months of treatment~     with TV-1106 compared with placebo on body fat composition.~   "
88377|NCT02410330|"~     In acute coronary artery disease, pre-clinical studies have indicated that, during a~     continuous infusion of intravenous perfluorocarbon containing microbubbles, the ultrasonic~     power delivered from a diagnostic ultrasound transducer is capable of restoring~     microcirculatory flow and improving epicardial recanalization rates obtained by conventional~     therapy, a process known by Sonothrombolysis. The investigators proposed to examine the~     feasibility, safety and efficacy of such an ultrasound guided approach in 100 patients with~     ST segment elevation myocardial infarction (STEMI).~   "
88378|NCT02410317|"~     The cesarean section is one of the most commonly performed surgeries in the world and it~     represents 20% of the births in France. Postoperative pain is moderate-to-severe during the~     first 48 hours after this procedure. Thereby its control is prominent for the medical team in~     order to shorten the duration of hospital stay as well as to permit an early return to daily~     activities for these surgical patients.~      Pain control after cesarean section is usually based on non-opioids and epidural~     administration of morphine if an epidural catheter has been previously placed for the~     procedure. However epidural morphine is associated with a number of side effects. Wound~     infiltration with local anesthetics has been widely used in the multimodal management of~     postoperative pain and it may reduce postoperative morphine consumption.~      In patients enrolled for emergency cesarean delivery with epidural catheter, the objective of~     this study will be to compare the analgesia provided by a local anesthetic wound 48-hours~     infusion through a multiorifice catheter (ropivacaine 2 mg/mL) versus epidural analgesia~     (epidural morphine bolus). Quality of pain control will be assessed with the measurements of~     morphine consumption and pain scores at rest and during mobilisation over 48 hours. At 3~     months, patients will be interviewed to assess their residual pain and their satisfaction.~      It is hypothesized that local anesthetic wound infusion would be non-inferior than epidural~     morphine analgesia to control pain after cesarean section, and be associated with a reduction~     of side effects related to the analgesics.~   "
88379|NCT02410304|"~     This study compares different methods of clinical evaluation (C) and/or ultrasound (B or D)~     concerning the rheumatoid arthritis in order to monitore the treatment. This study will~     provide the exact number of patients in remission according the 3 methods.~      It could allow to assess the concordance between the 3 evaluated methods. This study will~     permit to define the best method which limit the evolution of structural damages ( principal~     criteria).~   "
88380|NCT02410291|"~     Rectal toxicity limits dose escalated intensity modulated radiotherapy (IMRT) for prostate~     cancer. The dose volume constraints that predict for rectal toxicity require minimizing~     prostate motion and rectum and bladder filling of IMRT .5-15 . The volumetric changes and~     internal organ motion during prostate IMRT increases risk of PSA failure in patients with~     large rectums at the planning CT scans. Patient preparation for IMRT planning is crucial .The~     literature is limited regarding the effectiveness of educational intervention with behavioral~     reinforcement for patients, and a gap if exists literacy level is considered. Patients often~     cannot comprehend verbal or written instructions and have difficulties following through with~     recommended regimens.23 Using multimedia such as Internet, audio-visual media such as DVD and~     even the telephone can enhance patients' knowledge and understanding about importance of~     preparation for IMRT for prostate ca. Thomas's study showed that in patients undergoing~     radiotherapy and chemotherapy, the video group had lower anxiety scores compared with the non~     video group. At SOCC patients have been provided with verbal information about bladder and~     rectum preparation for prostate planning CT scan and IMRT. Patients should have a fullish~     bladder and empty rectum at the time of CT simulation. If the rectal diameter is > 4cm, the~     patient will be asked to empty his stool/gas and re-scanned. The 3- months review of patients~     preparedness for prostate IMRT showed that only 13/55 patients were adequately prepared but~     42/55 (76%) of patients needed to be re-scanned due to inadequate bladder (21/42, 50%) or~     rectum filling 28/42, 67%) . Also, 2/13 (15%) patients were still not prepared at the second~     resimulation despite that they received a phone call with the instructions. The investigators~     plan to investigate if a multimedia education strategy will decrease costly resimulation rate~     for patients with prostate cancer.~   "
88381|NCT02410278|"~     The primary objective of this study is to evaluate whether montelukast can reduce the~     severity of gastrointestinal (GI) events, measured by the Gastrointestinal Symptom Rating~     Scale (GSRS), after oral administration of dimethyl fumarate (DMF) in participants with~     relapsing forms of Multiple Sclerosis (MS). The secondary objectives of this study are as~     follows: To evaluate whether montelukast after oral administration of DMF in participants~     with relapsing forms of MS decreases discontinuations due to GI events and reduces the number~     of participants taking symptomatic therapies for GI events; To investigate the effect of~     montelukast on the incidence of flushing events after oral administration of 240 mg DMF in~     participants with relapsing forms of MS.~   "
88382|NCT02410265|"~     This controlled, three-arm, randomized (1:1:1), multi-site trial will evaluate the efficacy,~     feasibility and acceptability of cognitive-behavioral therapy (CBT)-based online guided and~     unguided self-help intervention to reduce Generalized Anxiety Disorder (GAD) in Indian~     university students. The investigators aim to assess if these novel electronic health~     (eHealth) interventions can be integrated into Indian university systems to increase access~     to efficacious, less stigmatized, and cost-effective mental healthcare.~   "
88383|NCT02410252|"~     This is a pilot study to evaluate the use feasibility of the iThermonitor, a continuous~     temperature monitoring device, as a clinical support and patient self-management tool in the~     management of pediatrics patients on myelosuppressive therapies for acute leukemia and other~     childhood cancers.~   "
88384|NCT02410239|"~     The purpose of this study is to determine the maximum tolerated dose (MTD) of mesenchymal~     stem cells (IT-MSC) in patients with active, advanced cerebral adrenoleukodystrophy (cALD).~   "
88385|NCT02410226|"~     The study will assess the benefit of using spinal ultrasound before epidural catheter~     insertion compared to the conventional palpation technique in women undergoing cesarean~     section.~   "
88386|NCT02410213|"~     This is a Phase II, open-label, non-randomized, multi-center, single arm study to~     characterize the pharmacokinetic and pharmacodynamics (PK/PD) profile of Ferric~     Carboxymaltose dosing in pediatric subjects with IDA after receiving either a 7.5 mg/kg or 15~     mg/kg dose of Ferric Carboxymaltose.~   "
88387|NCT02410200|"~     The primary objective of this study is to evaluate the effect of BG00012 (dimethyl fumarate)~     on brain magnetic resonance imaging (MRI) lesions in pediatric participants with~     relapsing-remitting multiple sclerosis (RRMS). The secondary objectives of this study are to~     characterize the pharmacokinetics of BG00012 in pediatric participants with RRMS and to~     evaluate the safety and tolerability of BG00012 in pediatric participants with RRMS.~   "
88388|NCT02410187|"~     Clinical experience has shown that metastasis can often be limited in number and location,~     and thus amenable to local treatment. The term oligometastasis describes an intermediate~     state of cancer spread between localized disease and widespread metastasis. The implication~     of such an intermediate state is that the disease can be cured by using metastasis-directed~     therapy. Historically, in some patients with oligometastases in the liver or lungs, surgical~     resection was often indicated, as abundant evidence suggested it could improve~     progression-free or overall survival. Recently, several studies have reported promising~     outcomes of >80% local control with Stereotactic Body Radiotherapy (SBRT) in patients with~     lung or liver oligometastases. Nonetheless, very few studies have focused on non-liver,~     non-lung extracranial oligometastatic lesions treated with SBRT, and such studies have~     limitations of a retrospective nature and small sample sizes.Because allmost studies are~     based on single-arm studies without appropriate controls, the level of evidence to support~     SBRT is weak. Randomized trials are therefore necessary to establish the utility of SBRT for~     oligometastatic disease.~      This study is designed as a randomized phase II study. Patients will be randomized between~     current standard treatment (Arm 1) versus standard treatment +SBRT (Arm 2) to all known~     disease.~   "
88389|NCT02410174|"~     The purpose of this study is to evaluate the safety and efficacy of the use of stereotactic~     body radiotherapy (SBRT) for the treatment of the primary tumor in renal cell carcinoma (RCC)~     in medically inoperable patients and/or patients who refuse surgery. Standard treatment of~     RCC is surgery. A number of non-surgical treatments of RCC are also available, but are highly~     invasive and are associated with significant side effects. SBRT is a non-invasive,~     non-surgical treatment that requires tumor immobilization and image guidance in order to~     deliver a very precise, high-dose treatment. This trial will assess the use of SBRT to treat~     primary renal tumors by determining the maximum tolerated dose and toxicity. Subjects~     enrolled in this study will then be followed and evaluated for toxicity, serum chemistry,~     complete blood count, and urinalysis. In addition, they will undergo renal scans to assess~     the functionality of their renal tissue.~   "
88390|NCT02410161|"~     Background: As the main alternative fuel to glucose for the brain, increased plasma ketones~     could potentially help compensate for brain glucose hypometabolism occurring during aging.~     The precursor long-chain n-3 polyunsaturated fatty acid (PUFA), α-linolenic acid (ALA), is~     normally mostly β-oxidized and so could potentially be used to stimulate ketogenesis in~     humans.~      Objective: To compare the impact of an ALA-rich supplement on the ketogenic response in young~     and older healthy adults.~      Design: Ten young and ten older adults will consume a flaxseed oil supplement providing 2 g/d~     of ALA for 4 weeks. Plasma ketones, free fatty acids, triglycerides, glucose and insulin will~     be measured over 6 h during two metabolic study days, one before and one at the end of the~     supplementation.~      Hypothesis: ALA-rich supplement for 4 weeks will increase ketone production in both groups.~   "
88403|NCT02409992|"~     The proposed research will focus on the development of a brief emotion-coaching (EC)~     parenting program (which directly targets child emotion awareness/recognition and affective~     empathy), that will be combined with a well-established parent management training program~     (Helping the Noncompliant Child; HNC) for treating oppositional defiant disorder (ODD) in~     children who also have limited prosocial emotions (e.g., lack of guilt and empathy, callous~     use of others).~   "
88427|NCT02409680|"~     Available data suggest that low dose aspirin may be a safe, widely available and inexpensive~     intervention that may significantly reduce the risk of preterm birth. However, this~     possibility needs to be proven in a properly designed randomized controlled trial (RCT) with~     preterm birth as the primary outcome. Such a clinical trial in a racially, ethnically and~     geographically diverse population could best be accomplished by the established~     infrastructure of the Global Network for Women's and Children's Health Research (GN).~   "
88391|NCT02410148|"~     Glaucoma remains a disease with an unclear and complex underlying pathophysiology. Recently,~     researchers have emphasized not only intraocular pressure (IOP) or vascular dysregulation,~     but also translaminar pressure's (TPG) role in glaucoma (TPG=IOP-ICP). A higher TPG may lead~     to abnormal function and optic nerve damage due to changes in axonal transportation,~     deformation of the lamina cribrosa, altered blood flow, or a combination thereof leading to~     glaucomatous damage. However only invasive ICP measurements are available within the~     contemporary medicine. The ideas for non-invasive ICP measurement have been approached since~     about 1980. Most of the proposed technologies were based on ultrasound and were capable of~     monitoring blood flow in intracranial or intraocular vessels, cranium diameter, or acoustic~     properties of the cranium. Broad research has extended into sonography of optic nerve sheath~     and its relation with elevated ICP. However, most of these correlation-based methods had the~     same problem—the need of individual patient specific calibration. Seeking to measure absolute~     ICP values, researchers from Kaunas University of Technology created a non-invasive method,~     which does not need a patient specific calibration. The method is based on direct comparison~     of ICP value with the value of pressure Pe that is externally applied to the tissues~     surrounding the eyeball. Intracranial segment of ophthalmic artery (OA) is used as a natural~     sensor of ICP and extracranial segment of OA is used as a sensor of Pe. The special two depth~     transcranial Doppler (TCD) device is used as a pressure balance indicator when ICP = Pe.~      The aim of our study is to assess TPG in patients with primary open open-angle glaucoma~     (POAG). In addition the investigators want to measure ICP in patients with papilledema (PE)~     in order to compare them with glaucoma patients.~   "
88392|NCT02410135|"~     The objective of this exploratory pilot study is to assess whether Mirabegron (Myrbetriq™)~     will improve the quality of sleep and Lower Urinary Tract Symptoms (LUTS) in men and women~     presenting with LUTS and disordered sleep.~   "
88393|NCT02410122|"~     While a fair amount of clinical data on Stargardt disease type 1 (STGD1) have been published,~     very little is known about Stargardt disease type 4 (STGD4). The ProgStar 04 study is an~     important opportunity to leverage the infrastructure, clinical trials sites, methods, and~     central reading center of the ProgStar program to investigate the progression of STGD4 and~     will help to establish patient cohorts worldwide for future clinical trials.~   "
88394|NCT02410109|"~     Perinatal depression is a significant concern, particularly for low-income women. Many cases~     of perinatal depression are complicated by comorbidities such as post-traumatic stress~     disorder symptoms, anxiety, and intimate partner violence. Providing perinatal mental health~     services to women in home visiting programs could have considerable public health~     significance. This study will develop and test an integrated model of mental health services~     embedded within home visitation (HV) programs. This model will (1) incorporate a protocol for~     systematic screening and referral; (2) strengthen formal linkages between HV programs and~     other components of service systems; (3) promote the capacity of service systems to provide~     evidence-based early intervention and treatment for depression; and (4) facilitate the~     receipt of early intervention and treatment services for perinatal depression and comorbid~     conditions. This will be the first model to our knowledge that systematically integrates~     screening, referral, and early intervention and treatment for perinatal depression and~     associated comorbidities within HV programs.~      The specific aims are:~        1. To develop an integrated model of perinatal depression care within HV programs. This~          integrated model (SCRIPT) will incorporate screening, referral, and individualized~          prevention and treatment services.~        2. To assess the feasibility of implementing the SCRIPT model with high fidelity in two HV~          programs. One HV program—DRUM Healthy Families—will use paraprofessionals as~          interventionists while the other program—M&I Nursing—will use nurses and social workers~          as interventionists.~        3. To determine the impact of the SCRIPT model on depressive symptoms and major depressive~          episodes.~   "
88395|NCT02410096|"~     The purpose of this study is to investigate the bronchial inflammation and~     hyperresponsiveness after oil supplementation. Before and after oil supplementation the~     investigators measure decrease in lung function after exercise-challenge in a cold chamber~     and increase of inflammatory markers in the blood.~   "
88396|NCT02410083|"~     The purpose of this study in to evaluate efficacy and tolerability of Clopirin and~     clopidogrel with aspirin in Korean Patients with post-percutaneous coronary artery~     intervention.~   "
88397|NCT02410070|"~     The objective of this study is to compare a minimal invasive approach with the conventional~     flexor carpi radialis approach for volar plating of distal radial fractures.~   "
88398|NCT02410057|"~     Formula composition has developed to resemble breast milk as close as possible, but there are~     still considerable differences between formula and breast milk composition, probably~     resulting in higher risk of overweight in childhood and higher incidences of infections in~     formula-fed infants. Protein levels are still higher and constituents such as~     alpha-lactalbumin lower in formula than in breast milk. By adding more alpha-lactalbumin to~     formula, rich in tryptophan, the resulting amino acid composition will allow further~     reduction of protein in formula. The investigators intend to include 320 infants, where 80~     will be exclusively breastfed and the remainder assigned in a double blind, controlled,~     randomized manner to one of three formula groups; two experimental, protein reduced formula~     with two different levels of alpha-lactalbumin and one group given standard infant formula.~     The intervention period is from 4-8 weeks until 6 months of age. The infants will be followed~     by growth parameters, blood-, urine- and fecal biomarkers and health parameters until 5 years~     of age. The experimental formula will possibly result in growth, metabolism and gut~     microbiota as well as health parameters more similar to those of breastfed infants~   "
88399|NCT02410044|"~     Evaluation of patient reported outcomes (PRO) / QoL regarding typical ailments in real-life~     patients with bone metastases treated with osteoprotective agents.~   "
88400|NCT02410031|"~     The study will be an observational, cross-sectional study of knowledge, understanding, and~     self-reported behavior among a sample of physicians with recent experience in prescribing~     Diane-35 or its generics in a total of five European countries. The primary objective of this~     study is to measure physician knowledge and understanding of the key information contained in~     the Diane-35 educational material: Patient information card, and Prescribers' Checklist.~      Specifically, the following objectives will be addressed:~        -  Investigate whether physicians have received any educational material related to~          Diane-35 or its generics~        -  Assess physicians' knowledge and understanding of key safety information pertaining to~          the patient information card~        -  Assess physicians' knowledge and understanding of key safety information pertaining to~          the following areas:~        -  Contraindications relevant to thromboembolism~        -  Risk factors for thromboembolism~        -  Signs and symptoms of thromboembolism~   "
88404|NCT02409979|"~     Room air insufflated during colonoscopy cannot be completely suctioned, is not easily~     absorbed and remains in the bowel for quite some time, resulting in prolonged bowel~     distension with the discomfort of bloating. Sufferers often experience a sensation of~     fullness and abdominal pressure, relieved only after expulsion of the residual gas, often~     accompanied by colic pain. This can be a lengthy process, and some patients continue to~     report pain as long as 24 hours after the procedure. Abdominal discomfort after colonoscopy~     is an adverse event commonly reported by patients, and definitely associated with the~     procedure. Published reports show that the use of carbon dioxide (CO2) insufflation~     significantly decreases bloating and pain up to 24 hours post-procedure. Preliminary results~     of the investigators' previous study about on-demand sedation colonoscopy in diagnostic~     patients showed that, compared with CO2 insufflation, the water exchange group (WE, infusion~     of water to distend the lumen during insertion; suction of infused water, residual air~     pockets an feces predominantly during insertion) achieved significantly lower real-time~     insertion pain scores. Moreover (insertion-withdrawal method) WE-CO2 had the lowest bloating~     scores just after the procedure and at discharge, comparable with those achieved by CO2-CO2.~     Compared with WE-CO2, the use of WE-air insufflation (AI) showed significantly higher~     bloating scores just after the procedure and at discharge; compared with CO2-CO2 differences~     were significant only at discharge. The investigators decided to conduct a prospective~     randomized controlled trial comparing WE-CO2, WE-AI and CO2-CO2. The investigators will test~     the hypothesis that patients examined by the combination of WE-CO2 will have significantly~     lower bloating scores at specific time points after colonoscopy than those examined using~     WE-AI or CO2-CO2. The investigators will also assess the impact of these three methods on~     patients comfort and activities in the post-procedure period.~   "
88405|NCT02409966|"~     There are different protocols to treat gum diseases. One relevant differential aspect is~     related to time. There are protocols that usually takes one to two months to be completed~     while other are completed within 24 hours. Although both protocols seem to provide clinically~     similar improvements, there are some positive aspects related to the short-term one. Among~     them lower number of clinical sessions, easier schedule and costs advantages. However, there~     are many other relevant aspects that can be helpful for patients and clinicians decisions~     regarding type of treatment.~      This study evaluates if and how clinically effective protocols used to treat periodontitis~     affect quality of life related to individual's oral statuses. In addition, the experiences of~     fear, anxiety and pain before and after these specific protocols are monitored.~   "
88406|NCT02409953|"~     Like in the full immersion, studied in the context of diving, immersion in water causes a~     cascade of events with hemodynamic and hormonal consequences.~      First, immersion leads to a relative hypervolemia by venous redistribution and then 40-60~     minutes later, hypovolemia by stimulating diuresis.~      Dilatation bath is helpful in relieving moderate pain the first stage of obstetrical labor.~      However, when the labor progresses, the dilatation bath is no longer sufficient and epidural~     analgesia remains the only effective method to control pain.~      Used before the realization of an epidural analgesia, dilatation bath could affect blood~     volume and thus worsen the hemodynamic consequences of the sympathetic block that is linked~     to the installation of sensory block of the epidural analgesia in the parturient (severe~     prolonged maternal hypotension that can cause a decrease of the placental perfusion and fetal~     distress).~      Before beginning a study in pregnant women, it seems essential to study the hemodynamic~     consequences of the dilatation bath in a comparable population of volunteers healthy young~     women and out of the obstetrical context.~   "
88407|NCT02409940|"~     Despite being a miracle of modern medicine, solid organ transplant recipients are always at~     risk of rejection, and remain dependent on lifelong immunosuppression. Currently used~     immunosuppressive drugs suppress the potential of immune system and interfere with the~     metabolism of medications. Cellular therapies currently being investigated for this purpose~     require the use of ablative radiotherapy. The investigators are using a less toxic strategy~     by harnessing the immunosuppressive potential of the MSCs in the Kidney Transplant (KTx)~     recipients and studying immunomodulation mediated by these cells in the KTx patients.~      Hypothesis MSCs interfere with signalling of Immune cells like T cells, B cells and Dendritic~     cells which leads to improve graft survival of renal transplant patients.~      Aim To investigate effect of MSCs on immune cell repertoire in a donor specific mediated~     response.~      The investigators aim to collect peripheral blood from 30 patients (10 patients for~     autologous cell infusion and 10 for allogeneic (donor derived cell infusion) at various time~     intervals following MSC therapy. 10 patients serve as controls on standard dose of drugs but~     without MSC infusion. This peripheral blood would be utilized for isolation of mononuclear~     cells and performing various immune assays on these cells in a donor specific response.~   "
88408|NCT02409927|"~     Lower brain glucose uptake is present before the onset of cognitive deterioration and may~     increase the risk of cognitive decline in Alzheimer's disease. Ketones are the brain's main~     alternative energy substrates. Medium-chain triglycerides (MCT) are rapidly beta-oxidized and~     are ketogenic. Large doses of MCT oil are linked to gastro-intestinal side effects due to~     incomplete absorption so the investigators examined whether homogenisation into a skim milk~     matrix (MCT-H) would both improve ketogenesis and reduce side-effects compared to MCT taken~     without homogenisation into a matrix (bulk MCT [MCT-B]).~      Hypotheses: (i) MCT-H will be better absorbed compared to MCT-B, so MCT-H will result in~     higher ketonemia and lower side effects in healthy adults. (ii) The effects of MCT-B and~     MCT-H on ketogenesis will be dose-dependent.~   "
88409|NCT02409914|"~     The purpose of this study is to investigate whether higher insulin resistance in young women~     with Polycystic ovary syndrome (PCOS) is associated with reduced cerebral metabolic rate of~     glucose (CMRglu). Brain volumes using magnetic resonance imaging (MRI) and quantitative~     cerebral glucose uptake using dynamic positron emission tomography (PET) were obtained. The~     potential relationships between anatomical and functional cerebral parameters and insulin~     resistance were assessed with the updated homeostasis model assessment (HOMA2-IR).~   "
88410|NCT02409901|"~     This randomized controlled trial (RCT) will examine the effect of a novel 12 month~     personalized exercise rehabilitation program compared to standard care following kidney~     transplantation. Return to work or find work rates, markers of subclinical atherosclerosis,~     functional capacity, body composition, quality of life, kidney function, and adherence to~     exercise will be measured. The investigators' primary hypothesis is that a 12 month exercise~     rehabilitation program will increase the return to work or find work rate in kidney~     transplant recipients. The investigators additionally hypothesize that a 12 month exercise~     rehabilitation program will prevent a decline in subclinical atherosclerosis, increase~     functional capacity, and increase lean muscle mass.~   "
88411|NCT02409888|"~     The purpose of this study is to investigate how behavioral treatments for alcohol use~     disorders affect behavior change.~   "
88412|NCT02409875|"~     This is a cohort study where families with infants are followed closely for three years. It~     aims to assess if parental weight status (normal weight vs. overweight/obesity), their~     physical activity and eating habit will influence their young children's growth and be~     helpful in childhood obesity reducing.~   "
88413|NCT02409862|"~     The neuropeptide oxytocin (OXT), originally known for its role in inducing uterine~     contractions has been shown to be involved in many of the social capacities that seem to~     change with age, such as emotion detection and identification, enhanced social memory,~     empathy, and trust. Thus, age-related changes in the OXT system may underlie differences~     between young and older adults in socioemotional functioning. Research on the effects of~     oxytocin in aging is very scarce; therefore, the purpose of this research project is to~     determine the effects of oxytocin on socioemotional aging. The aim of this research is to~     examine the behavioral and neural effects of OXT on decisions of trust in social~     interactions, perceptions of facial trustworthiness, the ability to read faces, and levels of~     empathy with other people in samples of young and older adults.~   "
88414|NCT02409849|"~     This is phase II study on the efficacy of octreotide lar as maintenance treatment after~     first-line chemotherapy for patients with unresectable or metastatic gastro-entero-pancreatic~     or esophageal neuroendocrine carcinomas.~   "
88415|NCT02409836|"~     The objective of this study was to examine the amount of dentifrice ingested and used by~     various age groups of children.~   "
88416|NCT02409823|"~     Antipsychotic drugs are characterized by blocking dopaminergic D2 receptors. They have been~     found to be effective and safe for the treatment of schizophrenia, bipolar disorders,~     depressive episodes associated with bipolar disorder, or psychotic symptoms in the context of~     Parkinson's disease. Atypical antipsychotics have lower blocking potency on D2 receptors, at~     the time that interact with serotoninergic, adrenergic and histaminergic receptors, among~     others. Quetiapine extended-release has the same clinical efficacy as the immediate-release~     formulation, but reduces the amount of daily doses, possibly contributing to increased~     treatment adherence.~      The purpose of this registry is to explore adherence to treatment, the occurrence of adverse~     drug reactions and the clinical outcomes in a sample of patients under treatment with~     atypical antipsychotics in several Central American countries. For this study, clinical data~     will be extracted from the medical records of 1000 patients with schizophrenia, depressive~     disorders or Parkinson's Disease with hallucinations. Occurrence of adverse drug reactions,~     namely weight gain, somnolence, extrapyramidal reactions and symptoms of orthostatic~     hypotension; adherence to treatment; and changes in quality of life and clinical status will~     be assessed during the first 8 weeks of treatment.~   "
88417|NCT02409810|"~     The primary aim of this pilot study is to establish the safety and feasibility of~     patient-controlled administration with dexmedetomidine for anxiolysis (PCA-DEX) during burn~     care dressings for patients with burn injury. The secondary aim is to determine the~     acceptability of PCA-DEX for anxiety symptom management by patients with burn injury and~     nursing staff caring for these patients. Objectives Primary Aim #1 Safety: To examine the~     safety of PCA-DEX as determined by the proportion of patients successfully completing the~     pilot trial without adverse effect which include significant hypotension, bradycardia, or~     agitation from uncontrolled anxiety. Primary Aim #2 Feasibility: The primary objective of~     this study is to establish feasibility of subject recruitment and protocol adherence in a~     pilot study of PCA-DEX in patients with burn injury requiring dressing changes. Feasibility~     will be defined by the following criteria: a) number and proportion of patients who consent~     to enrollment, b) proportion of eligible subjects enrolled prior to first dressing change, c)~     number of days on protocol that patients successfully use the PCS device, d) ability of burn~     nurses to adjust the pump and adhere to the infusion rates of the PCA-DEX protocol. Secondary~     Aim #1 Patient Acceptability: A secondary objective of this pilot study is to have patients~     evaluate PCA-DEX in regards to patients' willingness to use PCA-DEX prior to and during burn~     dressing changes to self-manage anxiety and their satisfaction ratings with anxiety~     self-management. Secondary Aim #2 Nurse Acceptability: Another secondary aim of this pilot~     study is to evaluate the nursing staffs' acceptability of the PCA-DEX protocol for patients'~     to self-manage anxiety surrounding burn care dressing changes. Hypotheses #1: PCA-DEX~     protocol will be safe to administer during burn care dressing changes. #2: PCA-DEX will be~     feasible to implement on the Burn Center at OSUWMC. #3: Patients will favorably appraise~     PCA-DEX for the self-control of anxiety associated with burn care dressing changes, and be~     satisfied with PCA-DEX for the management of anxiety. #4: Nursing Staff will favorably~     appraise PCA-DEX while performing burn care dressing changes.~   "
88418|NCT02409797|"~     The INSIGHT pilot study will measure forces applied by a doctor of chiropractic (DC) during~     the delivery of a specific, manually based chiropractic treatment for participants with low~     back pain.~   "
88419|NCT02409784|"~     Regional brain glucose hypometabolism occurs during aging and may contribute to the onset of~     aging-related cognitive impairment in humans. Ketones are the main alternative energy~     substrate to glucose for the brain. Several studies show that brain ketone uptake and~     metabolism are unaltered in cognitively-normal older persons and in Alzheimer's disease (AD).~     Nutritional ketosis is reported to have a positive impact on cognitive performances in mild~     cognitive impairment and AD. Nevertheless, changes in regional brain glucose and ketone~     uptake in adults are poorly understood during diet-induced experimental ketosis. The~     investigators hypothesis was that during diet-induced ketosis, brain ketone uptake would be~     directly correlated with the elevation of blood ketone levels and inversely correlated to~     brain glucose uptake.~   "
88420|NCT02409771|"~     The purpose of this clinical trial is to evaluate the effectiveness of the PRECIZON~     Presbyopic.~   "
88421|NCT02409758|"~     The purpose of this study is to evaluate the effectiveness and safety of the Comprehensive~     Voice Rehabilitation Program compared with Vocal Function Exercises in behavioral dysphonia.~   "
88422|NCT02409745|"~     Many studies have demonstrated that endometrial scratch significantly increase pregnancy rate~     in patients undergoing in vitro fertilization and embryo transfer. However, only a limited~     number of studies have been conducted in frozen thawed transfer (FET) cycle. Nowadays, in FET~     cycles, endometrial scratch is mainly performed on two different time points: 1) luteal phase~     in the previous cycle; 2)early follicular phase in the current cycle. However, few studies~     have compared the effectiveness of those two different endometrial scratch methods performed~     in different timing. The aim of this study is to find the best timing of endometrial scratch~     in FET cycles.~   "
88423|NCT02409732|"~     To evaluate the safety and efficacy of PDT with blue light and topical Levulan in the~     treatment of actinic cheilitis.~   "
88424|NCT02409719|"~     The investigators include patients attending the outpatient clinic in the area of Orthopedics~     and Traumatology of the investigators hospital with a diagnosis of knee osteoarthritis, which~     treatment requires surgery. Patients will be divided into two groups. In both groups, they~     will be given verbal, clear and detailed information on the approach to follow, the exercises~     given in brochures, and in the study group a schedule will be given in order to record~     rehabilitation exercises in patients after total knee replacement (TKA). Both groups will be~     assessed before and after surgery, together with outpatient follow-up by, WOMAC, Visual~     Analogue Scale and SF-12.~   "
88425|NCT02409706|"~     This study aims to explore the frequency and types of micronutrient deficiencies in a sample~     of UK children with CHD using standard and novel markers in blood. The study will also~     explore whether micronutrient deficiencies increase the risk of complications after heart~     surgery. This study will identify any nutrient deficiencies that need monitoring in clinical~     practice.~   "
88429|NCT02409654|"~     Stroke is a leading cause of mortality, morbidity and rising healthcare cost worldwide. In~     'real-world' practice, AF is often diagnosed too late at time of stroke and detection can be~     difficult because AF may be present without symptoms and intermittent in nature. Furthermore,~     utilization of adequate oral anticoagulation therapy (OAC) for stroke prevention is~     suboptimal in Hong Kong. The challenge is to identify AF prior to occurrence of stroke. The~     latest European guidelines recommend opportunistic screening for people >=65 years by pulse~     palpation followed by 12-lead ECG. However, 12-lead ECG requires a trained technician, time~     consuming, requires the patient to lie on an examination couch and is not readily available~     in most outpatient clinics in Hong Kong. A practical screening test is needed. Our study aims~     to evaluate the feasibility, acceptability and incremental cost of an outpatient based~     AFscreening program using the AliveCor device. Newly diagnosed AF patients will be randomized~     to routine care versus individualized stroke prevention strategy which consists of patient~     education, stroke and bleeding risk assessment, evidence-based OAC recommendation, patient~     audit and follow-up to improve OAC utilization for stroke prevention. We envisage this study~     will provide timely evidence to inform policy decisions concerning population-based~     AF-screening for AF for stroke prevention.~   "
88430|NCT02409641|"~     The WHO, states that age related cataracts account for 51 percent of worldwide blindness and~     affect about 20 million people. Surgery with intraocular lens (IOL) implantation is the first~     line treatment for cataracts, thus there is an on going effort to improve IOL design and~     performance.~      It is planned to compare three different IOL designs in a psychophysical test setting. Most~     IOL testing is done in 2D scenarios such as Early Treatment Diabetic Retinopathy Study~     (ETDRS) visual acuity or contrast sensitivity testing. The use of 3D scenario would allow~     testing a more real-life situation.~      As various downsides of different IOL designs have been reported, testing of IOLs before~     surgical implantation is a promising approach to maximise patient satisfaction. Known~     deficiencies include amongst others reduced contrast sensitivity or light intensity.~      To test three different IOL designs, it is planned to have 2D healthy young subjects look~     through a stable, table mounted spectacle frame, in which the different IOLs can be inserted.~     This allows for subjective testing of IOL's in a 2D and 3D scenario.~   "
88431|NCT02409628|"~     The purpose of study is to assess the safety and performance of EktoTherix™ Tissue Repair~     Scaffold in the treatment of full-thickness, dermatologic wounds created by the surgical~     removal of non-melanoma skin cancers.~      EktoTherix™ is a medical device developed by Neotherix Limited, manufactured by the polymer~     processing technique of electrospinning. Described as a tissue scaffold, EktoTherix is~     placed into the surgical wound to help the patients' own cells repair the wound, enhancing~     healing and improving quality (including cosmetic outcome). The tissue scaffold is completely~     absorbed by the body during the healing process, which means that there is no need to remove~     it when the wound is healed.~      All patients recruited into this study are treated with EktoTherix, are seen weekly until~     they heal and seen again at the final follow-up visit three months post-surgery.~      The investigators hypothesise that the use of EktoTherix will increase incidence of complete~     healing and result in an overall better cosmetic result of the healed wound.~   "
88432|NCT02409615|"~     In this pilot study, our central hypothesis is that two CAM modalities, hypnosis and healing~     touch as adjunct therapies to the standard of care, will improve analgesic use for post~     operative pain. In this pilot study the investigators will randomize 45 adolescents~     undergoing spinal fusion for idiopathic scoliosis to two test groups: Hypnosis with Pain~     Management Standard of Care for Post Op Pain, Healing Touch with Pain Management Standard of~     Care, and a control group (Pain Management Standard of Care only).~   "
88433|NCT02409602|"~     Dorsal clitoral artery Doppler examinations in women with bilateral internal iliac artery~     ligation due to postpartum hemorrhage (study group) and age-matched healthy puerperal women~     were performed regularly in the postoperative period, in order to evaluate possible effects~     of BIIAL on clitoral blood flow.~   "
88434|NCT02409589|"~     The purpose of this study is to compare a new intracavitary ECG guiding method for real-time~     positioning the tip of three-way valve type peripherally inserted central catheters versus~     conventional surface prediction length method in terms of single-time target rate.~   "
88435|NCT02409576|"~     Progress in the treatment of children with leukemia and lymphoma results in high cure rates~     but progress in the treatment of children and adolescents with solid tumors has been slow.~     Despite aggressive therapy with multimodality treatment involving surgery, radiation and~     chemotherapy, about two thirds of the patients with metastatic Ewing sarcoma (EWS),~     metastatic osteosarcoma (OS) and intermediate and high risk rhabdomyosarcoma (RMS) will~     relapse. The available second line therapies for relapse are limited and often not effective.~     There is a dire need to look for treatment options beyond conventional means for the~     treatment of these patients.~      Infusions of allogeneic natural killer (NK) cells in leukemia patients have shown to be~     tolerated well without inducing graft versus host disease (GVHD). There is also mounting~     evidence that NK cells have activity against solid tumors.~      In the lab the investigators tested NK cell activity against cell lines from different~     paediatric solid tumors. Among paediatric solid tumors, EWS and RMS are exquisitely sensitive~     to killing by expanded NK cells; NK cells also have activity against OS cells. Preliminary~     clinical data suggest that donor NK cells may exert antitumor activity in children with solid~     tumors undergoing allogeneic hematopoietic stem cell transplantation.~      Taking into account the safety of adaptive NK cell infusion, and their efficacy against EWS,~     RMS and OS, NK cells could be a powerful new tool in the treatment of paediatric solid~     tumors.~      The great anti-tumor activity of expanded and activated NK cells, together with the~     feasibility of infusing haploidentical NK cells in a non-transplant setting form a compelling~     rationale for the clinical testing of these NK cells in patients with sarcoma.~   "
88436|NCT02409563|"~     In clinical trials for treatment of allergic rhinitis a significant reduction of the total~     symptom score compared to baseline has been demonstrated by using nasal budesonide.Previous~     results in adults show that the assessment and monitoring del nasal fractional exhaled nitric~     oxide (nFeNO) is useful in controlling inflammation of nasal allergic rhinitis.~      Primary objective of this study is to evaluate efficacy of nasal budesonide (aqueous~     solution) on the nasal inflammation marker (nFeNO).~      Secondary outcomes are the evaluation of: changes in total nasal symptom score (Total Symptom~     Score, T5SS), changes in cell counts in nasal lavage (LN) and the changes reported sleep~     quality (Pittsburgh Sleep Quality Index, PSQI).~   "
88437|NCT02409550|"~     This project is an observational study for the Italian language validation of the CARATKids~     questionnaire investigating the asthma and coexisting allergic rhinitis control in children.~     113 patients with concomitant asthma and allergic rhinitis followed up from at least 3 months~     will be enrolled for the validation process at outpatient clinic of Pediatric Allergology &~     Pulmonology (PAP) of Respiratory Disease Research Center (RDRC) within the Institute of~     Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo~     (RDRC-IBIM CNR), Italy.~      The study will be completed in two medical examination, within 3-6 weeks of each other.~      CARATKids questionnaire, VAS (Visual Analogic Scale) and C-ACT (Children Asthma Control Test)~     will be filled by each patient.~      The main outcome is the Italian language validation of the CARATKids questionnaire~     investigating the coexisting asthma and allergic rhinitis control in children.~   "
88438|NCT02409537|"~     Background & Aims: The role of red wine in cardiovascular risk prevention has been documented~     by several epidemiological studies in patients and normocholesterolemic healthy individuals.~     However, it is unclear whether hypercholesterolemic individuals free of cardiovascular~     disease would equally benefit from moderate red wine consumption to prevent atherosclerosis~     and the development of cardiovascular disease.~      Methods: Forty (40) healthy volunteers males and females were recruited, divided into 2~     age-adjusted groups according to their total cholesterol levels; in asymptomatic~     hypercholesterolemics (AHC ), and normocholesterolemics (NC ). Total Antioxidant Capacity~     (TAC ), Lipid profile, Vitamin E, and cardiovascular risk indexes ( LDL /HDL and Vitamin E/TC~     ) were evaluated in the blood serum of all subjects prior to and 1 month after once daily red~     wine consumption as well as prior to and after being given a placebo drink following a 1~     month wash out period and resveratrol for 1 month after wash out period..~   "
88439|NCT02409524|"~     This is an open-label, single site, Phase II clinical trial to investigate the safety and~     efficacy of an individualized anti-cancer vaccine (CRCL-AlloVax) in advanced HCC patients~     after a minimum of 90 days on sorafenib.~   "
88440|NCT02409511|"~     Microalbuminuria (MA) is an independent cardiovascular risk factor in diabetic and~     non-diabetic subjects.~      However, in the setting of type 2 diabetes, microalbuminuria could be a marker of either~     early diabetic nephropathy or diffuse endothelial dysfunction. At present, there are no~     biomarkers that permit us to discriminate between these two conditions.~   "
88441|NCT02409498|"~     The purpose of this study is to determine the effectiveness of perineal pain control via~     injection of a local anesthetic to numb the pudendal nerve. The medication which is commonly~     used for this block is called marcaine. This is called a pudendal block it has been used in~     obstetrical and gynecologic surgeries for several decades. The goal of this study is to~     reduce the amount of pain medications taken post operatively after pelvic reconstructive~     surgery. Subjects undergoing pelvic reconstructive surgery will be recruited during the~     pre-op visit. Subjects will be asked about their pain level in the PACU and also asked to~     document their pain score days 1 and 2 post op. They will also be asked to keep a medication~     log for 14 days post op.~   "
88442|NCT02409485|"~     By teaching skills to improve the coordination of care and support in couples coping with~     head and neck cancer (HNC), this couple-based psychosocial intervention holds great promise~     for improving self-management, reducing costly hospitalizations and treatment interruptions,~     and improving both partners' quality of life. Home-based delivery will enhance future~     dissemination and outreach to those who do not have access to psychosocial services or live~     far away from their care centers. If found effective, the intervention may also have salutary~     downstream effects on the health and well-being of HNC patients and their partners.~   "
88443|NCT02409472|"~     Dukes B2-C colorectal cancer patients who had no evidence of disease at the end of their~     front line treatment (surgery and adjuvant radio-chemotherapy, if indicated) are eligible for~     the trial and randomized to two different surveillance programs. These programs differ~     greatly in the frequency of diagnostic imaging. They have similar schedules of physical~     examinations and carcinoembryonic antigen (CEA) assessments. Patients will receive baseline~     and yearly health-related quality of life (HR-QoL) questionnaires. Primary outcomes are~     overall survival and QoL.~   "
88444|NCT02409459|"~     This study investigates the efficacy and safety of an IV iron Injectafer in the treatment of~     iron deficient patients with fibromyalgia. Eligible subjects will be randomized in a 1:1~     ratio to receive Injectafer or Placebo on days 0 and 5. All treated subjects will be followed~     for efficacy and safety for 42 days.~   "
88445|NCT02409446|"~     The purpose of this study is to examine weather treatment with anthocyanins will affect lipid~     profile, markers of inflammation and oxidative stress in addition to antioxidative level in~     serum to the better in persons with increased risk of dementia.~      The purpose of this study is to examine weather treatment with anthocyanins will increase the~     score of relevant tests of cognitive function.~      The investigators will do an open pilot study where patients receive anthocyanin for 16~     weeks. 34 patients are expected to be included.~      In addition we will include 20 healthy Controls.~   "
88446|NCT02409433|"~     The Investigator plans to perform a prospective, randomized, single blinded, study that will~     compare patients treated with IV lacosamide to those treated with Phenytoin in the Intensive~     Care Unit (ICU) setting. The investigator will also evaluate the rate of clinically evident~     and sub-clinical seizures, and to compare long-term outcomes between patients treated with~     lacosamide and those treated with Phenytoin.~   "
88485|NCT02408926|"~     Young infants are most vulnerable to severe disease and even death when infected with~     Bordetella pertussis. The current vaccines and vaccination programs do not guarantee~     protection of neonates from this disease. Maternal acquired pertussis-specific antibodies~     show low concentrations with short persistence in newborns creating a susceptibility gap for~     infection between birth and the first vaccinations. A possible strategy to protect infants~     from birth is pertussis vaccination during pregnancy, which will increase the amount of~     passively transferred maternal antibodies.~      However, little is known regarding the effect of high titers of maternal antibodies on the~     infants immune responses to different pertussis vaccines (whole cell versus acellular).~     Humoral immune responses will be assessed in infants receiving whole cell versus infants~     receiving acellular pertussis vaccines. Functionality of the antibodies will also be~     analyzed.~   "
88447|NCT02409420|"~     Chronic low back pain (CLBP) is very common and causes much pain and disability. It costs the~     NHS billions of pounds in treatment every year and is the second leading cause of time off~     work. There are various treatments for CLBP, but the most effective are still only moderately~     helpful. Most people with CLBP receive physiotherapy, with varying results. Cognitive~     behaviour therapy (CBT) may offer more long term help than current treatments because it~     enables people to self-manage their condition. A new type of CBT, called Acceptance and~     Commitment Therapy (ACT), has produced particularly good results for chronic pain. However, a~     shortage of clinical psychologists means that most patients never receive CBT.~     Physiotherapists can successfully use CBT techniques with extra training, but this is not~     standard practice and ACT-based physiotherapy treatment has never been tested.~      The investigators have developed a short ACT-based treatment (PACT) for physiotherapists to~     deliver and aim to compare it with usual physiotherapy care. The investigators will recruit~     240 people with CLBP from three hospitals in South East London. They will be randomly divided~     into two groups, with half receiving PACT and the other half ordinary physiotherapy. PACT~     consists of two hour long sessions and one follow-up phone call, meaning fewer hospital~     visits for patients and more time during sessions for individualised treatment. It aims to~     encourage people to focus less on getting rid of their pain and more on moving forward with~     what is most important in their lives. The investigators will compare PACT with usual~     physiotherapy to see which is most successful at improving people's ability to function and~     their quality of life and which approach helps them to manage their back pain best in the~     long term. If PACT is effective, the investigators believe it could reduce the considerable~     burden of CLBP to patients, the NHS and society.~   "
88448|NCT02409407|"~     The role of hysteroscopy in infertility investigation is to detect possible intrauterine~     changes that could interfere with implantation or growth or both of the conceptus, with the~     invention of miniature hysteroscope, it is possible to perform hysteroscopy in an office~     setting (Outpatient hysteroscopy; OH), for diagnostic and certain therapeutic intervention.~     It is currently acknowledged as the 'gold standard' investigation of the intrauterine~     abnormalities.~      Cervical priming prior to diagnostic hysteroscopy softens the cervix and lessens the force~     needed for dilation, thereby potentially reducing the probability of procedural complication~     such as uterine perforation, cervical laceration, failure to dilate, and creation of a false~     track that can occur during cervical entry.~      Misoprostol is a prostaglandin El analogue, that can be administered either orally or~     vaginally, that can cause cervical ripening by inducing collagenolytic activity and synthesis~     of proteoglycans.~   "
88449|NCT02409394|"~     This open-label, randomized, two-period, two-treatment (single doses of 7.5 mg hetrombopag~     fasted or fed), crossover study was conducted to evaluate the effect of a high-fat meal on~     the pharmacokinetics of hetrombopag and mass balance study in 12 healthy subjects.~   "
88450|NCT02409381|"~     Prospective, multicenter, phase IV, open, randomized, parallel, controlled, in which 288 (two~     hundred and eighty-eight) participants of both sexes, aged between 40 and 75 years will be~     randomly allocated to one of two treatment groups , and treatment group 01 will be the dried~     extract of Curcuma longa complexed with phosphatidylcholine (Motore®), and treatment group 02~     will ibuprofen (Alivium®).~   "
88451|NCT02409368|"~     The purpose of the study is to determine the occurrence of high-grade (CTCAE v4.0 Grades~     3-4), treatment-related, select adverse events in patients with advanced or metastatic~     Squamous Cell Non-Small Cell Lung Cancer (SqNSCLC) with progression of disease during or~     after at least 1 systemic therapy.~   "
88452|NCT02409355|"~     This randomized, open-label study is designed to evaluate and compare the safety and efficacy~     of atezolizumab with gemcitabine + cisplatin or carboplatin in participants with~     chemotherapy-naive, Stage IV squamous NSCLC.~   "
88453|NCT02409342|"~     This randomized, open-label study will evaluate the efficacy and safety of atezolizumab~     compared with chemotherapy consisting of a platinum agent (cisplatin or carboplatin per~     investigator discretion) combined with either pemetrexed (non-squamous disease) or~     gemcitabine (squamous disease) in programmed death-ligand 1 (PD-L1)-selected,~     chemotherapy-naive participants with Stage IV Non-Squamous or Squamous NSCLC.~   "
88454|NCT02409329|"~     This study evaluates a mobile phone-delivered intervention, called REACH (Rapid~     Education/Encouragement And Communications for Health), in supporting adults with type 2~     diabetes in their self-management relative to a control group. The goal of this study is to~     determine if individually tailored content (based on the Information-Motivation-Behavioral~     Skills Model) delivered to the participant via text messages can improve the participant's~     glycemic control and adherence to diabetes medications. We will test whether our intervention~     improves adherence-related information, motivation, and behavioral skills and whether~     improving these mechanisms drives improvements in adherence and, in turn, glycemic control.~   "
88455|NCT02409316|"~     In this study, positron emission tomography (PET/CT) imaging will be used to evaluate~     estrogen receptor (ER) activity in sites of metastatic disease using the investigational~     radiotracer [18F]fluoroestradiol (FES).~   "
88456|NCT02409303|"~     This project will implement and evaluate an innovative healthcare service delivery model~     designed to promote earlier access to specialized intervention for toddlers with ASD. The~     Screen-Refer-Treat (SRT) model provides a coordinated and cost-effective approach to early~     identification and intervention by involving both medical and EI providers, and represents a~     practical and sustainable strategy for bridging the gap between ASD concerns and ASD~     intervention.~   "
88457|NCT02409290|"~     Tuberculosis (TB) is a common, infectious, bacterial disease that is spread when an infected~     person transmits their saliva through the air by coughing or sneezing. Despite the~     availability and effectiveness of affordable six-month treatments for tuberculosis (TB), the~     worldwide control of this disease is currently being impacted by the emergence of multidrug~     resistant TB (MDR-TB).~      MDR-TB refers to TB that is resistant to at least isoniazid and rifampicin. These are the two~     most powerful first-line drugs used to treat pulmonary TB. MDR-TB usually develops while a~     person is taking TB treatment due to either inappropriate treatment or failure of patients to~     comply with their treatment. This strain of drug-resistant bacteria can also be spread to~     other people through the air.~      MDR-TB leads to a considerable reduction in the effectiveness of standard short-length~     treatments and currently the standard treatments for MDR-TB can last as long as 24 months.~     With the incident rate of MDR-TB on the rise (511,000 new cases in 2007) and the lengthy~     duration of current treatments there is a need to investigate whether a shorter-length~     treatment using effective drugs is a global possibility.~      Three short course regimens of drugs will be evaluated alongside the World Health~     Organisation recommended 24 month regimen for the treatment of MDR-TB.~      A total of at least 1155 participants with MDR-TB will be recruited and followed for a total~     of 132 weeks.~   "
88458|NCT02409277|"~     The investigators have developed a tool to facilitate asthma self-management in children, the~     electronic-AsthmaTracker (e-AT). The e-AT changes ambulatory asthma care delivery to a new~     model that is continuous and proactive, focusing on prevention and control, rather than~     reactive and focusing on management of asthma attacks. The e-AT 1) engages parents in weekly~     monitoring of their child's chronic asthma symptoms, 2) guides parents to recognize warning~     signs of asthma attacks in order to prompt appropriate interventions and timely visits to~     Primary Care Providers, and 3) provides Primary Care Providers with real-time, objective~     patient data to assess the effectiveness of asthma therapy and prompt adjustments. In a~     preliminary study of the paper-based version of the AT, frequent users had significantly~     fewer emergency department (ED) and hospital visits. Parent comments during the e-AT pilot~     testing revealed that the tool was useful in helping them manage their child's asthma and~     were interested in assessing the tool's effectiveness and in identifying and addressing~     barriers to their sustained use of the e-AT.~      Improving asthma control in children will be facilitated by broad e-AT dissemination, and by~     identifying and addressing critical factors that contribute to parent sustained participation~     in self-management. The investigators propose to assess the effectiveness of the new~     ambulatory care model supported by the e-AT and conduct an e-AT process evaluation, assessing~     barriers and facilitators of sustained parent use. The investigators will engage parents~     throughout this study to identify and address themes that matter to them. The target~     population is children with persistent asthma, ages 2-17 years. The investigators have~     engaged 10 parents since conception of this project, from the planning to design and~     validation of the paper-AT, and the design and pilot testing of the e-AT. Input from parents~     was received through 3 iterative focus groups (one for the paper-AT and 2 for the e-AT) and~     facilitated discussions to inform the development of this proposal including research~     objectives and outcome measures. In addition, the investigators have recruited other key~     stakeholders for whom the results of the research will be relevant.~   "
88459|NCT02409264|"~     In South Africa, 27% of adult males and 31% of adult females experience insomnia. Insomnia~     may lead to feelings of fatigue and sleepiness, mood disturbances, cognitive difficulties,~     and may exacerbate symptomatology of co-morbid diseases. Current conventional treatment for~     insomnia includes both psychological and drug therapies. These conventional medications~     potentially may lead to dependency and withdrawal symptoms. Individualised homeopathic~     treatment is a process in which a homeopath selects the most appropriate remedy for the~     treatment of a condition in accordance with the fundamental principles of homeopathy. This~     treatment protocol may offer safe and effective treatment for insomnia disorder, however,~     more research is required on the subject. The aim of this study is to determine the effect of~     individualised homeopathic treatment of insomnia disorder in females using detailed case~     studies and the Insomnia Severity Index.~   "
88460|NCT02409251|"~     The aim of this study is to assess the effect of a simple intervention (a combination of~     education and feedback) on Antinuclear Antibody (ANA) testing.~      This aim was chosen because of the known overuse of many laboratory tests, of which ANA~     testing is one. As overuse of ANA tests can have negative consequences (both for patients and~     society), the investigators designed an intervention to see how this would influence~     Antinuclear Antibody testing by rheumatologists.~   "
88461|NCT02409238|"~     Dementia (Alzheimer's Disease) is sometimes called Type 3 Diabetes because of the strong~     connection between Type 2 diabetes (a function of insulin resistance) with Dementia.~      The investigators therefore hypothesize that Reducing Insulin Resistance using Intensive~     Lifestyle Intervention (Exercise and Weight loss) + Metformin Treatment in Prediabetic &~     diet-control-only Diabetic overweight and mildly cognitively impaired individuals 55 years or~     older would lead to better Cognitive Function (compared to standard care) after 2 years.~      Subjects will be monitored and assessed using a battery of Cognitive and psychological tests~     and PET scans to demonstrate glucose utilization in the relevant areas of the brain.~      This 3-year open-label study aims to recruit 360 subjects with 50% (180 subjects) randomized~     to receiving Intensive lifestyle intervention with Metformin (if diabetic) vs the other 50%~     who would receive only the usual standard level of care in the primary care setting.~   "
88462|NCT02409225|"~     Purpose: Home monitoring (HM) services supplied by different manufacturers (St Jude Medical,~     Biotronik, Medtronic) enables trained medical staff (doctors, electrophysiology nurses and~     technicians) to safely follow-up patients with implanted ICD/CRT-D remotely, with omitting~     unnecessary visits in outpatient clinic, shortening time to medical intervention and~     therefore help to decrease hospitalization rate among those patients.~      The RESULT study primary endpoint of the trial will be a composite of all-cause death or~     hospitalization due to cardiovascular reasons.~      The primary technical endpoint is to construct and evaluate a unified and integrated platform~     for data collected from RM devices manufactured by different companies: Carelink™~     (Medtronic®, Minneapolis, MN, USA), Merlin™ (Saint Jude Medical®, St. Paul, MN, USA) and Home~     Monitoring™ (Biotronik®, Berlin, Germany).~   "
88463|NCT02409212|"~     Study design: The study is a two arm randomised controlled trial (randomisation ratio 1:1)~     comparing an aerobic exercise training intervention to usual care plus exercise advice. The~     primary outcome is the feasibility of the intervention as novel primary therapy in men with~     localised prostate cancer.~   "
88464|NCT02409199|"~     This multicenter, randomized study will evaluate the efficacy and safety of apatinib compared~     to docetaxel treatment in patients with advanced gastric cancer. At the start of the trial,~     patients will be randomized to one treatment arm: Arm A: apatinib 850mg qd every 3 weeks; Arm~     B: docetaxel 60mg/m2 every 3 weeks. Tumor assessment will be done every 8 weeks according to~     RECIST 1.1. The primary endpoint is progression free survival (PFS).~   "
88465|NCT02409186|"~     Esophageal cancer is the sixth leading cause of cancer death in worldwide. Over the past 2~     decades, well-designed clinical trials have documented the clinical benefits of combination~     of chemotherapy and radiation for localized esophageal cancer, either as primary therapy or~     in neoadjuvant setting. Paclitaxel, a radiation sensitizer, has important single-agent~     activity in esophageal cancer. Paclitaxel-based chemoradiation has been the framework for the~     recent Radiation Therapy Oncology Group (RTOG) trials of nonoperative management of~     esophageal cancer. Accumulating clinical evidence suggests that Epidermal Growth Factor~     Receptor (EGFR) represents a viable target in the treatment of esophageal cancer. EGFR~     expression is associated with poor prognosis. Nimotuzumab binds specifically to EGFR on both~     normal and tumor cells and competitively inhibits the binding of Epidermal Growth Factor~     (EGF) and other ligands, such as Transforming Growth Factor-α (TGF-α). Preclinical models~     have suggested synergy between nimotuzumab, paclitaxel, cisplatin and radiation. For our~     phase II study in locally advanced esophageal squamous cell carcinoma (ESCC), the combination~     of cetuximab and chemoradiotherapy has demonstrated both response and survival benefits.~     Myara et al reported that nimotuzumab plus concurrent chemoradiation therapy (CCRT) was safe~     and provided statistically significant objective response (47.8%) and disease control rate~     (60.9%) in nonresectable ESCC. With all these, the investigators plan to study phase III~     trial.~   "
88466|NCT02409173|"~     Obesity is currently one of the most serious public health problems. Its prevalence is~     increasing sharply in recent decades, even in developing countries, leading to global~     epidemiology condition. Metabolic syndrome (MS) consists of an association of metabolic and~     cardiovascular disorders including central obesity, insulin resistance, dyslipidemia and~     hypertension in the same patient. Obstructive sleep apnea (OSA) is a common clinical~     condition in more than 60% patients with MS. It is still controversial in the world~     scientific literature whether treatment of OSA with Noninvasive Positive Pressure Ventilation~     (NPPV) in severely obese patients with and without MS is effective. The NPPV effectively~     reverses hypoxemia in patients with OSA, therefore justified the hypothesis that NPPV will~     reduce insulin resistance, ghrelin and resistin and raise adiponectin levels in a group of~     severely obese individuals with and without MS undergoing bariatric surgery. Objectives: To~     investigate the effects of Noninvasive Positive Pressure Ventilation on inflammatory markers,~     sleep, pulmonary function, BMI reduction and health related quality of life in severe obese~     patients with and without metabolic syndrome undergone to bariatric surgery.~   "
88467|NCT02409160|"~     Obesity is a major public health problem in developed and developing countries, causing a~     range of respiratory and metabolic changes. There is a strong correlation between obesity and~     cardiorespiratory sleep disorders. The weight loss reduces the comorbidities and improves the~     quality of life, but clinical treatment it is not effective for a long period. In this~     context, currently bariatric surgery is an option for the real weight loss in the long term.~     Obstructive sleep apnea (OSA) is a common clinical condition observed in patients with~     obesity. The primary aim of this protocol are to assess the inflammatory profile of severe~     obese patients undergone to bariatric surgery, through systemic and adipose markers of~     inflammation. A secondary objective is study the impact of this surgery on sleep variables~     and quality of life. Investigators hypothesized that weight loss induced by bariatric surgery~     reduces systemic inflammatory profile, improve sleep quality and quality of life of subjects~     with severe obesity. Will participate in this study, patients with severe obesity (BMI > 40~     or 35 to 39.9 kg/m2 associated comorbidities), with indication of bariatric surgery, screened~     Bariatric Surgery Service of Santa Casa de São Paulo in São Paulo. Inclusion criteria are~     severely obese, bariatric surgery indication and agreement to participate in the study. Are~     excluded patients with BMI > 55 kg/m2, clinical instability, mental instability or~     significant and unrealistic expectations of surgery. Patients will be assessed before and~     after bariatric surgery, 90, 180 and 360 days. The evaluation protocol will consist of~     clinical history, vital signs, neck and waist circumference, clinical analysis of blood~     inflammatory markers, lung function tests, maximal ventilatory pressures, full overnight~     standard polysomnography, excessive daytime sleepiness scale, cardiovascular risk, quality of~     life and personal satisfaction questionnaires.~   "
88468|NCT02409147|"~     This study will explore the feasibility of initiating a uterine transplant program at UNMC.~     Using the procedural templates established by a successful Swedish team, the investigators~     will identify emotionally and socially stable females of reproductive age with intact ovaries~     who are unable to gestate a child due to congenital or acquired uterine factor infertility~     (UFI). Women will be 21 to 35 years of age upon entry into the protocol, with normal ovarian~     reserve and otherwise healthy for pregnancy. After careful screening, participants will~     undergo egg harvest, in-vitro fertilization, and embryo cryopreservation using standard~     methods. Women who successfully complete in vitro fertilization and cryopreservation of at~     least six embryos will be eligible to receive implantation of a deceased donor uterus. After~     a period of observation to ensure normal menstrual cycling and graft viability, embryo~     implantation will be undertaken. Gestations will be carefully monitored by our high-risk~     pregnancy specialists. Medical research interventions include uterine harvest from a deceased~     donor, surgical implantation of the organ utilizing standard transplant techniques, careful~     post-transplant follow-up including immune suppression therapy tailored to minimize fetal~     compromise, and careful management of pregnancy. After childbearing is complete (at most two~     gestations), the donor uterus will be removed. In addition, open-ended interviews and written~     surveys will be conducted to elicit ethical and psychosocial concerns arising from the~     experience of subjects and their families, health care providers, and the wider community.~     The investigators intent is to monitor outcomes lifelong for transplant recipients and~     live-born infants.~   "
88469|NCT02409134|"~     Psychological well-being and cognitive function will be measured in patients enrolled on the~     primary study, NCT01790568, a phase 2 trial of vorinostat plus tacrolimus and methotrexate to~     prevent graft versus host disease following unrelated donor hematopoietic stem cell~     transplantation. Validated questionnaires will be administered to assess patients' level of~     depression, anxiety, quality of life, perceived cognitive functioning, and sleep quality.~     Cognitive testing will include reliable and valid measures of processing speed, attention,~     executive function, episodic memory, and visual learning and memory. The purpose of this~     study is to determine whether these measures are feasible to administer in patients before~     and at early time points after bone marrow transplantation .~   "
88470|NCT02409121|"~     Hematopoietic cell transplantation (BMT), or commonly referred to as blood and marrow~     transplantation (BMT), is a potentially life-saving therapy for many malignant and~     non-malignant conditions. Despite advances over the past decade, which have led to improved~     outcomes, BMT remains an intense treatment modality often requiring prolonged inpatient-based~     care. While many patients endure the acute complications of the procedure, it is common for~     BMT patients and their caregivers to experience increased risk of financial and emotional~     burden, hospital readmission, and health service utilization. This highlights the importance~     of active involvement of BMT patients in their own health care (self-efficacy). For pediatric~     BMT patients, parents are the primary caregivers. As such, parental activation on behalf of~     the child (patient) plays a critical role in effective patient-parent-provider partnerships,~     which is increasingly recognized as the optimal model for health care delivery, particularly~     for those facing life-altering medical treatments. It is essential to develop effective~     strategies to enhance this partnership. Health information technology (IT)-mediated tools~     offer the potential to overcome constraints in health care delivery limited by provider time,~     complicated health information, and financial pressures. Significant gaps in knowledge exist~     on the use of health IT tools using low-cost and well-accepted delivery platforms in routine~     inpatient care, especially for high-risk or critically ill populations. The investigators~     hypothesize that a tablet-based tool displaying personal health information could provide a~     platform to promote caregiver (parent) activation and enhance health communication. In this~     clinical research study, the investigators will conduct a pilot study of an educational~     health IT system developed on a tablet (Apple iPad®) that the investigators refer to as a~     Personalized Engagement Tool (PET) or the BMT Roadmap. The Apple iPad® was selected as the~     platform for delivery of the educational intervention given its ergonomic features. The~     implementation and evaluation of the BMT Roadmap information system in caregivers of children~     undergoing BMT have been based on the generation of user (caregivers and patients) needs that~     incorporated well-established user-centered design processes including qualitative and~     quantitative research methods (published and unpublished data). The assembled investigators~     represent a strong multidisciplinary team with complementary and integrated expertise who are~     well-poised to carry out the proposed research. The Protocol or Study Team includes pediatric~     BMT physicians, Center for Health Communications Research (CHCR) staff, health informaticist,~     biostatistician, and psychologist. This research study is innovative because it addresses a~     gap in the literature on the role of health IT in parent activation on behalf of the child in~     the inpatient setting of a high-risk BMT population. The BMT Roadmap information system~     provides a robust experimental framework for further testing the utility of other care~     components that relate to parent activation or participation and for potential adoption in~     other complex medical conditions. The new knowledge gained herein will thus contribute to the~     evidence base of how health IT improves health care quality and provide the basis of further~     study in a full-scale clinical trial.~   "
88471|NCT02409108|"~     The purpose of this study is to gather information on how safe the hyperthermia treatment~     delivered via the Exatherm-TBH (the device that will heat your blood and deliver it back to~     you), added to the best supportive care is to patients who have advanced persistent or~     recurrent, unresectable Cancer.~   "
88472|NCT02409095|"~     This is a study planned to determine and compare immunogenicity and reactogenicity of~     DTP-HB-Hib vaccine of SIIL delivered either with disposable-Syringe Jet Injector (DSJI) or~     disposable-syringe needle in total 340 Indian infants aged 6 to 8 weeks at the time of~     enrollment.~      It will provide information to aid managers, device regulatory control officials,~     immunization programs, and clinicians who make decisions on safe clinical practice standards.~   "
88473|NCT02409082|"~     The investigators explore the presence of AD factors beta-amyloid and tau in CSF and plasma~     to verify AD diagnosis in patients with acute hip fracture. Clinical dementia test is~     performed prior to operation. Blood samples and CSF samples are collected at surgery and~     blood samples are collected postoperatively at intervals. Mortality is assessed at 30 days, 3~     months and 1 year. Morbidity is assessed at , 3 months and >1 year. Neuromarkers specifically~     addressing the inflammatory component are to be analyzed and correlated to outcome together~     with AD markers, as above.~   "
88492|NCT02408835|"~     This study investigates the use of a negative pressure wound therapy device (PICO™, Smith &~     Nephew Healthcare, UK) on clean, closed surgical wounds, in patients who are undergoing~     inguinal lymphadenectomy for metastatic carcinoma of cutaneous origin.~   "
88572|NCT02407782|"~     Scabies remains a frequent condition that affects adults and children. The aim of this study~     is to compare the efficacy and safety of two drug treatments against scabies in children and~     their close contacts. One group will apply topical permethrin 5% and the other group will~     receive oral ivermectin.~      Both groups will be treated twice, once at inclusion and the second time 10 days later. Both~     treatment regimens have been used widely and are safe to use.~   "
88474|NCT02409069|"~     The goal of this study is to investigate the influence of transcutaneous vagus nerve~     stimulation 1. on the noradrenergic system in the brain and 2. on memory, in healthy~     volunteers.~      Preclinical and clinical studies indicate that noradrenaline plays a role in the working~     mechanism of vagus nerve stimulation. This study will investigate if the effects of invasive~     vagus nerve stimulation can be replicated with transcutaneous vagus nerve stimulation.~      The release of noradrenaline in the brain will be measured non-invasively by the P300~     component of event-related potentials in the electro-encephalogram (EEG) via an auditory~     oddball paradigm.~      Research to elucidate the working mechanism of non-invasive neurostimulation can help to~     identify subpopulations who will respond well to a treatment and can provide insights that~     could contribute to the optimalisation of the stimulation parameters, with as possible~     consequence a better clinical outcome.~      Some studies indicate that stimulation of the vagus nerve can optimally influence memory,~     possibly via the noradrenergic system. This study will investigate if the effects of invasive~     vagus nerve stimulation on memory can be replicated with transcutaneous vagus nerve~     stimulation.~      The influence of transcutaneous vagus nerve stimulation on memory will be measured via a~     neuropsychological memory task that investigates the ability to focus attention. The~     correlation between the performance on the memory task and the signal analysis of the~     auditory oddball task could give an indication about the underlying working mechanism of~     transcutaneous vagus nerve stimulation on memory.~      This will be the first step to investigate whether transcutaneous vagus nerve stimulation can~     be used as innovative intervention for cognitive decline.~   "
88475|NCT02409056|"~     This project is the test of the effectiveness of the Chronic Disease Self-Management Program~     which will be translated to a worksite setting.~   "
88476|NCT02409043|"~     The purpose of this research study is to determine if there are molecules in the blood that~     indicate when a person has had a stroke, and what type of stroke they have had, so that~     appropriate treatment may be begun as soon as possible. This study is also being conducted to~     determine whether these molecules can help to predict long-term health following stroke. Some~     of these potential molecules, also called biomarkers, include Neuronal biomarker ubiquitin~     C-terminal hydrolase-L1 (UCH-L1), Glial markers such as glial fibrillary acidic protein~     (GFAP), and a neuroprotective enzyme called angiotensin converting enzyme 2 (ACE2), which has~     activity that has been shown to be helpful cardiovascular disease and shown to be altered in~     animal models of acute stroke, where it is also shown to provide neuronal protection.~   "
88477|NCT02409030|"~     The purpose of this study is to validate a diagnostic test that combines different blood~     markers to identify and correctly classify patients with Alzheimer's disease (AD) compared to~     individuals with behavioural variant frontotemporal dementia (bvFTD, patient control) versus~     cognitively healthy individuals (healthy control).~   "
88478|NCT02409017|"~     To assess which of two commonly utilized insulin drip protocols has better outcomes when used~     during the labor process.~   "
88479|NCT02409004|"~     This will be a single centre, Phase I, open-label, one cohort, one dose level,~     fixed-sequence, drug interaction study in healthy volunteers. The objective of this study is~     to determine the effects of rifampin on the pharmacokinetics of ataluren under fasting~     conditions.~   "
88480|NCT02408991|"~     The purpose of this study is to measure the concentration of cells and proteins in the~     patient's blood during administration of Nuopogen (Filgrastim), a medication that is FDA~     approved for stem cell mobilization, in combination with a programmed pneumatic compression~     device (PPCD) (Art-Assist Device). The Art-Assist Device is an FDA approved device that~     promotes blood flow in the patient's legs. A patient will be prescribed this device and this~     drug to help improve the poor circulation in his/her leg. The use of Nuopogen along with the~     Art-Assist Device has not been approved by the FDA and is considered experimental.~      This study is not designed to find out how well the Art-Assist Device works, nor how well the~     drug works in mobilizing stem cells. Instead, it is a study of how well cells lining blood~     vessels in calf respond to increases in shear stress, and how well the increase in the~     population of certain cells in the blood stream effect how the new blood vessels will form.~     It is important for clinical reasons, and for the purposes of this study, that the patient~     uses the Art-Assist Device as prescribed on a daily basis as discussed with the patient's~     doctor~   "
88481|NCT02408978|"~     Oxford Pharmascience Ltd (the Sponsor) is developing a new naproxen tablet formulation (the~     study drug, OXP005), for the potential treatment of rheumatic and painful conditions. The~     study will compare the study drug to an already marketed formulation of prescription strength~     naproxen (Naprosyn® the reference product) by looking at the relative impact of both products~     on gastroduodenal (GD) irritation by performing a specialist procedure called an endoscopy~     (or more specifically, a gastroscopy). The safety and tolerability of the study drug will~     also be assessed.~   "
88482|NCT02408965|"~     Excessive bleeding after dilation and evacuation (D&E) requiring interventions is common,~     occurring in approximately 30% of cases at one large abortion-providing clinic. Uterotonic~     prophylaxis at the time of D&E, particularly with methylergonovine maleate (MM), is a common~     practice among D&E providers despite nearly no evidence for its efficacy. Finding ways to~     decrease excessive bleeding after D&E has the potential both to improve patient safety and to~     reduce costs of provider-initiated interventions. The investigators propose a randomized,~     controlled trial to investigate the efficacy of MM prophylaxis versus placebo in decreasing~     excessive bleeding measured by a composite outcome among women undergoing D&E at 20 to 24~     weeks.~   "
88483|NCT02408952|"~     This study evaluates the implementation and effectiveness of two modalities of Screening,~     Brief Intervention and Referral to Treatment (SBIRT) to reduce adolescent alcohol and other~     drug (AOD) use in a large pediatrics clinic.~   "
88484|NCT02408939|"~     Postresuscitation disease is characterized by post-insult systemic inflammation, adrenal~     insufficiency, and circulatory failure. Such severe pathology may be associated with~     increased susceptibility to infectious complications and increased risk of death due to~     postresuscitation septic shock. The latter may be attenuated by stress-dose steroids. In this~     re-analysis of synthesized randomized clinical trial (RCT) data, the investigators will use~     individual patient data from two prior RCTs of in-hospital cardiac arrest (NCT00411879 &~     NCT00729794), in order to determine the effect of stress-dose steroids on the severity of~     postresuscitation infectious complications, and more specifically, on the risk of septic~     shock-associated death.~   "
88486|NCT02408913|"~     Background:~      - Ebola virus is a rare disease that starts with fever and muscle aches, but can lead to~     death. The 2014 Ebola outbreak in West Africa is the largest to date. There are no approved~     treatments for Ebola. Researchers want to see if two new vaccines VRC-EBOMVA079-00-VP~     (MVA-EbolaZ) and VRC-EBOADC069-00VP ( cAd3-EBO ) are safe and able to induce an immune~     response against Ebola.~      Objectives:~      - To see if the two new vaccines are safe and if they cause any side effects. Also, to study~     immune responses to the vaccines.~      Eligibility:~      - Healthy adults ages 18-66~      Design:~        -  Participants will get one or two study vaccine injections depending on the study group~          they are assigned to. Each injection will repeat the same schedule:~        -  A needle and syringe will inject the vaccine into an upper arm muscle.~        -  1-2 days later, participants must call the clinic to report how they feel.~        -  For 7 days they will check their temperature with a thermometer given to them. They will~          look at the injection site, and measure any redness or swelling with a ruler. They will~          write down any symptoms they have.~        -  In the first 2 months, participants will have at least 6 clinic visits and 1 phone~          contact. At each visit, participants will be checked for health changes or problems.~          They will tell how they feel and if they have taken any medications. Blood and urine~          samples may be collected.~        -  Participants might need to have extra clinic visits and laboratory tests if they have~          health changes that need to be checked.~   "
88487|NCT02408900|"~     Background:~      - Primary lateral sclerosis (PLS) is a rare disease. It leads to weakness in the muscle of~     the arms, legs, and face. People with PLS develop muscle stiffness called spasticity.~     Researchers want to find a better way to measure this. They want to see if ultrasound, which~     uses sound waves to look at parts of the body, can measure spasticity and stiffness in~     muscles.~      Objective:~      - To see if ultrasound can detect and measure muscle spasticity in people with PLS.~      Eligibility:~        -  People ages 18 75 who have a diagnosis of PLS and are enrolled in protocol 01-N-0145.~        -  Healthy volunteers ages 18 75.~      Design:~        -  Participants with PLS will have 1 study visit. Healthy participants will have upto 5~          visits. Each visit will be about 2 hours.~        -  Participants will have tests of muscle strength. They will be examined. They will push~          their arms and legs against researchers in different positions.~        -  Participants will have tests of muscle stiffness. Their arms and legs will be moved~          while they relax.~        -  Participants will have a muscle ultrasound test. They will lie on a table. Gel will be~          placed on the skin over the muscles of the arms and legs. A probe, like a microphone,~          will be moved over the skin. Researchers will look at several muscles.~        -  Participants should try to stay still during the ultrasound. It may be done several~          times and may be done by different examiners.~   "
88488|NCT02408887|"~     Background:~      - Papillary thyroid cancer (PTC) often spreads to lymph nodes in the neck. This can be hard~     to detect. People often have lymph nodes removed anyway, and researchers want to study if~     this is a good idea.~      Objective:~      - To compare the effectiveness of removing lymph nodes in the neck that show no evidence of~     cancer along with the thyroid, or removing only the thyroid.~      Eligibility:~      - Adults age 18 and older with PTC or thyroid nodules suspicious for PTC, with no evidence~     that the disease has spread in the body.~      Design:~        -  Participants will be screened with medical history, physical exam, blood tests, scans,~          and x-rays.~        -  Participants will:~        -  Answer questions. They may have a tumor biopsy.~        -  Have a flexible laryngoscopy. A small tube will pass through the nose to the vocal~          cords.~        -  Group 1: have surgery to remove the thyroid gland only. Lymph nodes in the neck will be~          removed if the cancer has spread.~        -  Group 2: have surgery to remove the thyroid and lymph nodes in the neck.~        -  At all post-surgery visits, participants will answer questions and have blood drawn. In~          addition:~        -  1 day: laryngoscopy.~        -  2 weeks: possible laryngoscopy.~        -  3 months: ultrasound of the thyroid and neck.~        -  Discuss whether to try hormone treatment and/or radioactive iodine.~        -  Possible diagnostic whole body radioiodine scan (WBS). Participants will swallow a~          capsule or liquid and lie under a camera.~        -  6 months: ultrasound and maybe laryngoscopy.~        -  1 year: diagnostic WBS and ultrasound. Participants may get thyroid stimulating hormone.~        -  Participants will have annual follow-up visits for 10 years. They will have a physical~          exam, blood drawn, scans, and may complete a questionnaire.~   "
88489|NCT02408874|"~     Background:~      - Nanosilver is tiny silver particles. Many products contain nanosilver, like antimicrobial~     cleaning supplies and antimicrobial fabrics. Some products also contain nanosilver in a~     solution that people inhale. The companies that make these products claim they can help boost~     the immune system.~      Objective:~      - To learn if inhaling nanosilver affects the lung s immune system. In addition, to see if~     nanosilver affects lung function and if it gets absorbed into the bloodstream after it is~     inhaled.~      Eligibility:~      - Healthy, non-smoking adults ages 18 60.~      Design:~        -  Participants will be pre-screened by phone.~        -  Participants will then be screened with a medical history and physical exam. They will~          give blood and urine samples.~        -  Participants will have lung function tests. They will breathe into a spirometer. It has~          a mouthpiece attached to a tube that is connected to a computer.~        -  Participants will have a methacholine challenge test. They will blow into a spirometer.~          Then they will inhale methacholine.~        -  Eligible participants will have 3 study visits over 2 5 weeks. At each visit, they will~          repeat some of the screening tests.~        -  At visit 1, participants will have a bronchoscopy. For this, an intravenous line is~          placed in an arm vein. Electrodes are placed on the chest. A tube is placed through the~          nose and into the airways. The airway is washed. A sample of cells is taken.~        -  At visit 2, participants will get the study treatment. They will inhale a nanosilver~          solution mist. They will have lung function tests before and after treatment.~        -  Participants will collect their urine from the time they get the treatment until they~          return to the clinic the next day.~        -  At visit 3, participants will turn in their urine. They will have another bronchoscopy.~   "
88490|NCT02408861|"~     This phase I trial studies the side effects and best dose of nivolumab when given with~     ipilimumab in treating patients with human immunodeficiency virus (HIV) associated classical~     Hodgkin lymphoma that has returned after a period of improvement or does not respond to~     treatment, or solid tumors that have spread to other places in the body or cannot be removed~     by surgery. Monoclonal antibodies, such as ipilimumab and nivolumab, may block tumor growth~     in different ways by targeting certain cells. Ipilimumab is an antibody that acts against a~     molecule called cytotoxic T-lymphocyte antigen 4 (CTLA-4). CTLA-4 controls a part of your~     immune system by shutting it down. Nivolumab is a type of antibody that is specific for human~     programmed cell death 1 (PD-1), a protein that is responsible for destruction of immune~     cells. Giving ipilimumab with nivolumab may work better in treating patients with HIV~     associated classical Hodgkin lymphoma or solid tumors.~   "
88491|NCT02408848|"~     There are few studies evaluating the value of 3D echocardiography in children undergoing~     congenital cardiac surgery. The aim of this observational study is to describe common and~     uncommon congenital malformations with the help of 3D echo and compare the findings and the~     measurements with those obtained with conventional 2D echo.~   "
88493|NCT02408822|"~     Paclitaxel is an antiproliferative drug that can limit vascular intimal hyperplasia.~     Paclitaxel-coated balloons already have indications in the treatment of peripheral arterial~     disease.~      This randomized controlled trial is designed to prove the superiority of a drug-eluting~     balloon catheter (Paclitaxel-coated balloon) over a plain balloon catheter in the treatment~     of stenosed autogeneous and prosthetic vascular accesses, in hemodialysis patients.~      The hypothesis is that use of drug-eluting balloon will improve post-interventional patency~     of the access, and therefore, limit numbers and days of hospitalization for maintenance of~     hemodialysis vascular accesses.~   "
88494|NCT02408809|"~     The investigators of this study aim to evaluate the impact of a new orthopaedic related~     smoking cessation discussion on smoking behavior. Considering the high prevalence of patients~     who smoke and receive orthopaedic management, we are interested in determining whether an~     orthopaedic smoking cessation discussion impacts smoking abstinence self-efficacy over time~     compared to a general smoking cessation discussion.~   "
88495|NCT02408796|"~     This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with~     either unilateral or bilateral acute otitis media with tympanostomy tubes (AOMT). Eligible~     subjects will receive a single dose of 6 mg OTO-201 to the affected ear(s). The study is~     designed to characterize safety, procedural factors and clinical effect of OTO-201~     administered in subjects with AOMT.~   "
88496|NCT02408783|"~     A large number of mothers are uncertain of the date of their last menstrual period and where~     there is a high incidence of small-for-dates babies, there is a real need for a method of~     estimating gestational age that is both rapid and accurate for early referral and management~     of preterm newborns to reduce their mortality and morbidity. The National Family Health~     Survey 2005-06 reports that the proportion of low birth weight babies (LBW) in India is 22%.~     Of these LBW babies, the proportion of prematurity is not known in the survey as it is~     difficult to measure gestational age of the newborn due to lack of reliable and valid scores~     with ease of use at the primary health centers. Different scores to assess maturity have been~     developed namely New Ballard score, Dubowitz score and Meharban Singh score. It is not known~     whether these scores have regional, geographical, racial or ethnic robustness. It has also~     been found that these scores tend to overestimate newborns > 37 weeks and underestimate those~     >32 and < 37 weeks. The investigators conducted a cross sectional study to validate three~     neonatal gestational age (GA) assessment scores namely New Ballard, Dubowitz and Meharban~     Singh with the reference standard i.e. GA assessed by LMP using Naegeles rule and validated~     by gestational ages also assessed by at least one ultrasound (GA-LMP), in Indian newborns~     delivered at a tertiary hospital. The investigators derived a new Simplified Gestational Age~     Score (SGAS) using the best applicable items from the three validated scores and assessed~     its accuracy with the reference standard (GA-LMP). This score has only 4 items (posture, skin~     texture, breast and genital assessment) and community health workers can be trained in~     implementing SGAS due to its simplicity. The investigators propose a study in the GN sites to~     validate this simplified method of assessment of the GA using our SGAS protocol.~   "
88497|NCT02408770|"~     The primary objective of this study is to determine the effects of the antiprogestin~     ulipristal acetate (UA) on the epithelial and stromal compartments of the normal breast in~     women at increased risk of breast cancer (BC) and to relate these effects to quantitative~     changes on multiparametric magnetic resonance imaging (MRI). The goal is to define predictive~     imaging biomarkers for subsequent testing in randomised prevention trials of antiprogestins.~   "
88498|NCT02408757|"~     As elaborated above only one study reported ultrasonographic changes of the width of the~     lateral ventricle during clamping of EVD/LD and indicated that ultrasound monitoring might be~     suitable. No firm data exists about the change of the width of the third ventricle, the~     diameter of the optic nerve or brain perfusion during clamping of the EVD/LD, although the~     width of these structures has been shown to depend on intracranial pressure. Ultrasonographic~     measurements of changes of the width of the third ventricle or the diameter of the optic~     nerve would have some advantages compared to the ultrasonographic assessments of the lateral~     ventricles. First, the width of the third ventricle can be measured easier and more reliable~     than the width of the lateral ventricles (better defined insonation plane and therefore~     higher repeatability of measurements) 3. Second, whereas assessments of the width of the side~     and third ventricles with ultrasound depend on the temporal bone windows (10 to 15% of~     patients have insufficient temporal bone windows), the measurement of the diameter of the~     optic nerve does not have this limitation and can therefore be performed in almost all~     patients. Hence, measurement of the diameter of the optic nerve would allow to overcome one~     major limitation of transcranial ultrasound. The latter limitation for transcranial~     ultrasound could also be minimized by the use of an ultrasound contrast agent (SonoVue®), but~     this was also not yet studied. The use of an ultrasound contrast agent would in addition~     allow to study changes of brain perfusion during clamping of EVD/LD.~   "
88499|NCT02408744|"~     The aim of this study was to evaluate the impact in safety and efficacy of a new formulation~     of prolonged-released Pirfenidone in the progression of renal damage in patients with Chronic~     kidney Disease (CKD).~   "
88500|NCT02408731|"~     Shock is a condition of reduced tissue perfusion, resulting in the inadequate delivery of~     oxygen and nutrients that are necessary for cellular function. The current resuscitative~     agents can extend patient's life to a limited extent. Centhaquin (PMZ-2010) in very low doses~     reduced blood lactate levels, improved blood pressure, cardiac output, survival and proved to~     be a highly effective resuscitative agent. The investigators are conducting a phase I~     clinical study in humans to evaluate the safety, tolerability, pharmacokinetics and~     pharmacodynamics of centhaquin citrate in normal healthy volunteers.~   "
88501|NCT02408718|"~     The purpose of this study is to determine whether a training program in the use of ambulatory~     assistive devices (such as canes, walkers, etc) can reduce falls and increase functional~     mobility and neural connectivity in people with Multiple Sclerosis.~   "
88522|NCT02408445|"~     This research study in infant males with Klinefelter syndrome (47,XXY) will learn more about~     body composition (muscle and fat) and male hormones and look at the effect of testosterone~     shots on body composition. The Investigators know that older boys and men with Klinefelter~     syndrome often have more fat compared to muscle than adults without Klinefelter syndrome, but~     we do not know if this difference is present at birth or develops over time. The~     Investigators will learn if body composition and motor skills are improved with testosterone~     treatment in infants with Klinefelter syndrome.~   "
88573|NCT02407769|"~     Assess the impact in body composition and handgrip strength of the nocturne supplementation~     by a month with BCAA (Enterex hepatic in patients awaiting liver transplantation)~   "
88599|NCT02407431|"~     The purpose of the PaTH Network IPF Clinician-Patient Partnership Cohort is to use clinical~     data from electronic health records (EHR) and patient reported outcomes (PRO) to answer~     questions of clinical importance to patients with Idiopathic Pulmonary Fibrosis, providers,~     and other stakeholders.~   "
88502|NCT02408705|"~     Each subject will be allocated to 2 periods of 3 months of once daily dosing with either~     liraglutide (1.2 mg) or placebo treatment (in random sequence) as add on to usual intensive~     insulin treatment. Wash-out period between treatments will be 1 month.~      The trial can be divided into the following periods:~        -  Screening~        -  Treatment period 1~        -  Washout period~        -  Treatment period 2~        -  Follow up Visit~      Mixed Meal Tolerance Test (MMTT) enriched with paracetamol:~      At the beginning and end of each period a MMTT (Fortimel complete) enriched with paracetamol~     will be performed to assess the remaining beta-cell function via obtained maximal plasma~     C-peptide levels as well as the gastric emptying.~      Experimental / Hypoglycaemic clamp :~      At the end of each period (Visit 8, 15) a hypoglycaemic clamp will be performed. After the~     subject completed the MMTT on day 1, the subject will stay in the clinical unit to prepare~     for the hypoglycaemic clamp with an variable insulin infusion intravenously in order to~     obtain a steady state of a plasma glucose (PG) level of 5.5 mmol/L overnight until~     approximately 08:00. At 05:00 hours 10%-[6,6-2H2] glucose solution will be given i.v. as a~     primed (9.6mg/kg/min) for one minute and a constant (0.08 mg/kg/min) infusion until the last~     blood sampling of the plateau 4.0 mmol/L will be performed.~      At 08:00 hours in the morning at day 2, insulin infusion will be increased to 1.5 mU/kg/min~     for each subject and the PG will be kept at a plateau of 5.5 mmol/L by a controlled variable~     intravenous infusion of glucose (10% glucose enriched with 4mg [6,6-2H2] glucose /ml) for one~     hour. Afterwards, PG is allowed to fall to a plateau of 3.5 mmol/L, then to a nadir of 2.5~     mmol/L, then to a blood glucose of 4.0 mmol/L and finally back to a level of 5.5 mmol/L for~     safety reasons. Blood sampling for measurement of [6,6-2H2] glucose, glucagon, insulin,~     counterregulatory hormones, lactate, free fatty acids, glycerol, vital signs, hypoglycaemic~     symptoms questionnaire and hypoglycaemic awareness will be performed at each PG plateau.~   "
88503|NCT02408692|"~     The purpose of this research study is to determine how body weight changes the drug level of~     an emergency contraceptive pill containing a hormone called levonorgestrel (LNG). This~     emergency contraceptive is available to women without a prescription, but has recently been~     found to not work as well to prevent pregnancies in women of higher body weight. The overall~     goal of this research is to improve the effectiveness of contraception for women, no matter~     their weight.~   "
88504|NCT02408679|"~     The purpose of this clinical study is to evaluate the metrological properties of a~     questionnaire that aims to identify the vitamin D status in reference to a vitamin D blood~     dosage.~   "
88505|NCT02408666|"~     The goal of this project is the development of an EEG-cap (min. 21 electrodes) with~     user-friendly active dry electrodes that meets the expectations of the users regarding~     comfort and esthetics, without losing sight of the functional and technical demands for~     recording high quality EEG signals. The purpose is to use the EEG-cap to investigate clinical~     neurological disorders (e.g. epilepsy). The EEG-cap could also be used at home so that~     hospital admission in the EMU can be avoided for some patients and an increasing number of~     patients can be examined.~      In Phase 1 of the project epilepsy patients and their family will be interviewed about their~     personal experiences with the condition, EEG registrations, daily life, ... . In addition~     EEG-technologists and neurologists will be interviewed about their experience with EEG~     registrations and what features their dream EEG-cap would have. The purpose is to gain~     insight in the wishes and expectations of the end users so we can take this into account when~     designing of the EEG-cap. This interview is anticipated to take approximately 1 hour.~      Minimum 5 - maximum 50 patients and their family will be interviewed. Minimum 5 - maximum 50~     EEG-technologists or neurologists will be interviewed.~      The results of the interviews will be analysed by the design company pilipili nv.~   "
88506|NCT02408653|"~     The goal of this project is the development of an EEG-cap (min. 21 electrodes) with~     user-friendly active dry electrodes that meets the expectations of the users regarding~     comfort and esthetics, without losing sight of the functional and technical demands for~     recording high quality EEG signals. The purpose is to use the EEG-cap to investigate clinical~     neurological disorders (e.g. epilepsy). The EEG-cap could also be used at home so that~     hospital admission in the EMU can be avoided for some patients and an increasing number of~     patients can be examined.~      In Phase 2 of the project will comprise of an EEG-registration with the different types of~     electrodes in healthy volunteers. For each volunteer the EEG-recording with dry electrodes~     will be compared to the EEG-recordings with conventionally used wet electrodes (bridge and~     cup electrodes). In addition each volunteer will undergo a somato-sensory evoked potential~     (SSEP) measurement with different types of electrodes. Analogously to the EEG-registrations,~     for each volunteer the SSEP measurement with the dry electrodes will be compared to the SSEP~     measurement with conventionally used wet electrodes (bridge and cup electrodes). Each~     EEG-registration will take between 5 and 10 minutes.~      Minimum 2 - maximum 10 healthy volunteers will be included.~      There will be an visual and clinical evaluation of the EEG-signals (blinded) and a technical~     evaluation of the EEG-signals. User experience will also be collected.~   "
88507|NCT02408640|"~     The aim of this randomized controlled trial is to investigate the effects of a Swedish~     Internet-based treatment program for individuals from the general population with a regular~     cannabis use.~      The primary hypothesis to be tested is that the use of the Internet-based treatment program~     will be associated with more cannabis-free days in comparison to only access to information~     about cannabis use and its harmful effects.~      The secondary hypotheses to be tested are:~        1. That the use of the Internet-based treatment program will be associated with a larger~          decline in cannabis consumption (frequency and quantity) among individuals with regular~          cannabis use in comparison to only access to information about Cannabis use and its~          harmful effects.~        2. That the use of the Internet-based treatment program will be associated with a larger~          decline in alcohol consumption, depression and anxiety and increased sense of coherence~          in comparison to only access to information about Cannabis use and its harmful effects.~        3. That the proportion of individuals who seek professional help or talk to their relatives~          or friends about reducing or stopping cannabis use will be greater among those who use~          the Internet-based treatment program than among those who only have access to~          information about cannabis use and its harmful effects.~      Recruitment procedure and baseline measures Study participants will be recruited through an~     advertisement on Cannabishjalpen.se. Interested individuals will answer questions about~     gender, age, country of birth, educational attainment, employment, marital status, living~     situation, and cannabis use.~      The intervention group Individuals randomized to the intervention group will directly after~     randomization answer questions about alcohol use, use of drugs other than alcohol and~     cannabis, depression, anxiety, a sense of context and whether they during the last 12 months~     has received professional help to reduce or quit their cannabis use or during the same period~     have raised this issue with their relatives or friends.~      Further, they will fill out a survey on Internet-based services for individuals who wish to~     reduce or quit their cannabis use. The study participants will then be informed that they,~     within two days, will gain access to an internet based treatment program designed to help~     them quit their cannabis use and that they through the program will have the opportunity to~     communicate with a therapist. Within the next two days, they will gain access to the~     internet-based treatment program, they will have access to it for two months and they will be~     contacted again after three months to answer questions about their cannabis and alcohol use,~     as well as about other previously mentioned issues.~      The control group Individuals randomized to the control group will undergo exactly the same~     procedure as the intervention group. The difference is that the control group will be~     informed that they in about three months will gain access to an internet based treatment~     program designed to help them quit their cannabis use (i.e. when the data collection for~     follow-up is completed).~      Otherwise, participants in both groups will have the opportunity to use factual information~     that is available to everyone on Cannabishjalpen.se.~      Follow-up procedure Study participants who were randomized to the intervention group will~     have access to intervention in two months. Three months after recruitment to the study, study~     participants from both groups will get an automated email invitation to participate in the~     three-month follow-up. The email will include a personalized link that when clicked on will~     redirect the participant to follow-up page where they will be asked to once again answer~     questions about their cannabis and alcohol use, depression and anxiety, seeking professional~     help for cannabis use as well as the help of family or friends and questions about whether~     they have used any other internet or telephone services to reduce or quit their cannabis use.~     The entire follow-up procedure will be completed via the internet.~   "
88558|NCT02407964|"~     This is a multi-center, open-enrollment, retrospective, non-interventional epidemiologic~     study without any clinical treatment. Its primary objective is to understand 1) incidence of~     drug-induced liver injury, including incidences among all the hospitalized patient, among~     patients in department of hepatic diseases, digestive diseases, oncology, hematology etc.,~     individually; 2) epidemiologic characteristics of drug-induced liver injury, including~     suspected medications, clinical types, histological characteristics, severity and outcomes.~   "
88508|NCT02408627|"~     The goal of this project is the development of an EEG-cap (min. 21 electrodes) with~     user-friendly active dry electrodes that meets the expectations of the users regarding~     comfort and esthetics, without losing sight of the functional and technical demands for~     recording high quality EEG signals. The purpose is to use the EEG-cap to investigate clinical~     neurological disorders (e.g. epilepsy). The EEG-cap could also be used at home so that~     hospital admission in the EMU can be avoided for some patients and an increasing number of~     patients can be examined.~      Phase 3 of the Project will be divided into a Phase 3a and Phase 3b.~      Phase 3a of the project will comprise of an EEG-registration with the different types of~     electrodes in epilepsy patients with prominent interictal epileptiform discharges (IEDs) on~     EEG. For each epilepsy patient the EEG-recording with dry electrodes will be compared to the~     EEG-recordings with conventionally used wet electrodes (bridge and cup electrodes). Each~     EEG-recording will take approximately 10 minutes.~      Minimum 2 - maximum 10 epilepsy patients will be included.~      There will be an visual and clinical evaluation of the EEG-signals (blinded) and a technical~     evaluation of the EEG-signals. User experience will also be collected.~   "
88509|NCT02408614|"~     The study objectives are the following: 1) To examine the acute vascular responses to~     continuous low- and moderate-intensity exercise and interval training; and 2) To examine the~     influence of age and gender on these responses.~   "
88510|NCT02408601|"~     Background and study aims:~      The investigators are carrying out a clinical trial of two different sealant materials to~     compare the retentivity and decay inhibiting properties of the above said materials. it is a~     split mouth study, wherein the 2 sealant materials will be placed on the exactly opposite~     placed molars of 180 healthy school children in the age group between 7 - 10 yrs of age.~      who can participate? school children in the age group between 7 - 10 yrs of age with non~     decayed contra lateral permanent 1st molars at a school in the southern part of India.~      what does the study involve? over a period of 18 months, the retentivity and the decay~     preventing effects of these two sealant materials( RESIN BASED SEALANTS AND ART SEALANTS)~     will be clinically assessed by us.~      possible benefits/ risks of participating in the trial the participants will be not be~     exposed to any kind of risks as it is a non invasive procedure the possible benefits may be~     preventing decay to the permanent molar in the long run~      study start date/duration of the study? MARCH 2015 is the month wherein the sealant~     applications have started and expected to last till the April of 2017~      funding? self funded study~   "
88511|NCT02408588|"~     Using a pulse oximeter, the investigators have developed an algorithm that assesses central~     volume status. Pregnant women present some unique opportunities for us to investigate the~     algorithm under different circumstances. The investigators want to specifically investigate~     an algorithm with women who undergo regional anesthesia such as epidurals, with women who~     undergo fetal surgery, and with women in labor and giving birth (and the recovery time~     following delivery). This will help the investigators understand the central volume status~     changes that women experience in these unique circumstances. The Investigators also want to~     put the pulse oximeter on the fetal hand when possible during certain maternal fetal~     interventions. The Investigators would like to examine the algorithm with data from the~     fetuses.~   "
88512|NCT02408575|"~     Pilot study on safety, tolerability and clinical performance/randomized double-blind~     active-controlled pilot-study. Patients are being recruited from patients of the Tinnitus~     Center of Regensburg and groupwise randomized. Control groups are being treated with hearing~     aids without notch-filter. Patients and raters are blinded, only the coworker, who is~     programming the hearing aids, is informed about the group assigned.~      A Hearing aid with notched amplification filters frequencies in a specific manner, depending~     on the individual tinnitus frequency. Through this special filtering the neuronal functional~     changes of the auditory cortex are supposed to be affected therapeutically.~   "
88513|NCT02408562|"~     This is a phase I, randomised, placebo-controlled study to assess the safety and tolerability~     of two 2-weeks cycles of i.c.v. administration of sNN0031 infusion solution to patients with~     PD of moderate severity with persisting on-off symptoms in spite of other PD medications.~   "
88514|NCT02408549|"~     Assessment of long-term safety and efficacy of oral lacosamide (LCM) as an adjunctive therapy~     for uncontrolled primary generalized tonic-clonic (PGTC) seizures in subjects >= 4 years of~     age with idiopathic generalized epilepsy (IGE). This study will enroll subjects from the LCM~     SP0982 (NCT02408523) study.~   "
88515|NCT02408536|"~     The purpose of this study is to retrospectively evaluate treatments and outcomes of patients~     with low grade serous ovarian carcinomas in Italy.~   "
88516|NCT02408523|"~     Evaluating efficacy & safety of lacosamide versus Placebo in a blinded fashion as add-on~     Therapy for Primary Generalized Tonic-clonic (PGTC) seizures in subject 4 years of age with~     idiopathic generalized epilepsy currently taking 1 to 3 antiepileptic drugs. Maximum duration~     of study drug administration is 28 weeks. Eligible subjects may choose to enter the~     open-label extension study after completion.~   "
88517|NCT02408510|"~     The goal of this proof of concept/feasibility study is to use rigorous methodology to explore~     links between daytime energy status and nocturnal fat metabolism in healthy adults.~   "
88518|NCT02408497|"~     A single arm phase II study of prostate motion for prostate cancer to primarily compare~     prostate motion between different treatment duration for IMRT and VMAT.~   "
88519|NCT02408484|"~     This study will assess the efficacy of Octafibrin, a fibrinogen concentrate in in the~     on-demand treatment of spontaneous or traumatic bleeding episodes in paediatric patients less~     than 12 years of age.The planned study duration is up to 5 years. The study will be~     considered completed when a minimum of 6 subjects (i.e., at least 3 subjects aged between 0~     and <6 years and 3 subjects aged between 6 and <12 years) have at least one documented~     bleeding episode and when in total a minimum of 2 surgical procedures have been performed.~      All patients will undergo a pharmacokinetic (PK) study after screening. This will have a~     duration of 14 days, after which a patient can be treated for a bleeding episode or planned~     surgical procedure when they occur.~   "
88520|NCT02408471|"~     This study is a non-randomized, consecutive enrollment, one-year post-approval study of~     patients who are treated with the Ascension® MCP.~   "
88521|NCT02408458|"~     This study is being conducted to gather long-term data of the performance of the Miromatrix~     Biological Mesh.~   "
88523|NCT02408432|"~     Any time the words you, your, I, or me appear, it is meant to apply to the potential~     participant.~      The goal of this clinical research study is to learn if adding mesenchymal stem cells (MSCs)~     to standard of care drugs can help control heart failure that may have been caused by~     anthracyclines (a type of chemotherapy drug used in cancer treatment). The safety of the MSCs~     will also be studied.~      MSCs are a type of stem cell that can be removed from bone marrow and grown into many~     different cell types that can be used to treat cancer and other diseases, such as heart~     failure. The MSCs used in this study were collected from healthy donors and are stored and~     grown in a laboratory at MD Anderson.~      This is an investigational study. MSCs are not FDA-approved or commercially available. They~     are being used for research purposes only. The study doctor can explain how they are designed~     to work.~      Up to 45 participants will be enrolled in this study. All will take part at MD Anderson.~   "
88524|NCT02408419|"~     About 10-30% of all patients with hip fracture have only insufficient analgesic effect of a~     femoral nerve block. One of the possible causes of this failure to provide analgesia from a~     single nerve block could be the that other nerves occasionally are involved in transmitting~     the pain signal. One of the nerves that is believed to give off branches to the hip is the~     obturator nerve.~      With ultrasound it is possible to make a selective proximal nerve block of the obturator~     nerve.~      The aim of this trail is to give patients with hip fracture and only insufficient effect of a~     femoral nerve block a supplementary obturator nerve block in a randomized manner with either~     local anesthetics or placebo in order to access the preoperative analgesic effect.~   "
88525|NCT02408406|"~     This partially randomized pilot clinical trial develops and studies a software program,~     called PatientCareAnywhere, to see whether it can help patients communicate with their~     doctors and other healthcare providers, and educate themselves about their cancer and~     treatment options. A program that can help patients learn about their cancer and treatment~     options, and allows the patient's healthcare providers to receive their questionnaire~     results, may help patients identify and get help to treat their symptoms.~   "
88526|NCT02408393|"~     Compare the effect of paravertebral block (PVB) with Ropivacaine or placebo on the incidence~     of chronic pain 3 months after breast cancer surgery.~   "
88527|NCT02408380|"~     This study investigates whether there is a link between disease activity/progression in~     patients receiving Gilenya and expression of a putative biomarker signature in patients with~     multiple sclerosis.~   "
88528|NCT02408367|"~     Multiple Sclerosis (MS) is a chronic autoimmune disease where lymphocytes inflict damage to~     the axons and myelin sheaths of the central nervous system. Persons with multiple sclerosis~     (pwMS) were long advised to avoid physical activity but the benefits of exercise to improve~     cardiovascular and cognitive functions in pwMS have become important aspects of standardized~     rehabilitation programs. Recent findings show that the achieved adaptations through exercise~     are associated with the intensity dependent lactate increases during exercise. This~     dose-response relationship between the mode and the exercise intensity implicates the~     relevance of the exercise protocol as higher exercise intensities seem to facilitate greater~     benefits, also in pwMS.~      This pilot study evaluates the influences of acute bout of moderate physical exercise~     (cycling) and relaxation on cognitive functions at three time points.~      Primary outcomes are the differences (at timepoint t2) of cognitive functions assessed via~     the Symbol Digit Modalities Test (SDMT) and the Brief Visuospatial Memory Test Revised~     (BVMT-R) T1-3 of the BICAMS battery.~      Results should into a randomised controlled Trial that investigates the specific influences~     of a three-week training intervention on Brain-derived neurotrophic factors (BDNF), Insulin~     Growth Factor-1 (IGF-1) and Vascular Endothelial Growth Factor (VEGF) as central~     neurobiological parameters of neuroplasticity, cardiorespiratory Fitness and cognitive~     functions.~   "
88529|NCT02408354|"~     The purpose of this project is to study the efficacy of triheptanoin oil in patients with~     Alternating Hemiplegia of Childhood (AHC) due to ATP1A3 gene mutation.~   "
88530|NCT02408341|"~     Background: Propofol effects dose-dependent myocardial depression, but there is little~     clinical data available regarding the direct impact of propofol induction on myocardial~     function.~      Objectives: The purpose of this study was to examine the impact of propofol-based anesthesia~     induction on cardiac function in low-risk patients.~   "
88531|NCT02408328|"~     Apnea is a common discharge-delaying diagnosis in the Newborn Intensive Care Unit. While it~     is relatively more common in extremely premature infants, it also occurs frequently in late~     preterm and even full term infants. Since the majority of all births include late preterm~     infants and full term infants, the absolute number of late preterm and full term infants with~     apnea remains significant. Evidence-based guidelines for the management of apnea in such~     infants do not exist. Current management falls into two distinct but very different~     categories. This study will compare these two distinct management strategies.~      Our study will be a prospective, randomized pilot trial to provide data regarding (a)~     feasibility for recruitment and study protocols and (b) provide preliminary data regarding~     efficacy of both treatment arms.~      Our primary objective will be to test the hypothesis that early discharge and outpatient~     monitoring of late preterm and term infants with apnea of prematurity results in decreased~     length of hospital stay, is safe, and results in improved patient satisfaction, as assessed~     by the PedsQL questionnaire and Impact on Family Scale.~      Our study population will include infants who meet the following criteria: (1) Born at~     greater than or equal to 34 0/7 weeks gestation; (2) Are assigned a diagnosis of apnea,~     bradycardia, and/or oxygen desaturations by the primary clinical team; (3) Have met all other~     discharge criteria (i.e. feeding maturity, temperature regulation, etc.) so that~     apnea/bradycardia/desaturation remains the final discharge issue for at least 7 days.~      Infants enrolled in this research study will be randomized to in hospital observation versus~     early discharge home with caffeine and a home monitor. Neither strategy is experimental as~     both are currently utilized by neonatologists locally and nationally. A direct comparison of~     the two treatments, however, has never been undertaken in a study. If an infant is assigned~     to the in hospital group, they will remain in the hospital until an apnea free period of at~     least 5 consecutive days has been established. Outpatient follow up will occur per unit~     standard and typically includes a nursing visit and a doctor visit within 2-3 days of~     discharge. Caregivers will be asked to complete 3 brief questionnaires at enrollment, at 1~     month after hospital discharge, and at 6 months of age. Each questionnaire will ask about~     topics such as satisfaction with hospital stay, quality of life, and numbers of acute care~     visits and/or rehospitalizations. Alternatively, if an infant is assigned to the early~     discharge group, caffeine will be given to the infant and if after a 3 day period no further~     apnea is noted the infant will be discharged home with continued daily caffeine therapy by~     mouth as well as a home monitor. Caffeine is a very commonly used drug in neonates and has an~     excellent safety profile. Side effects are minimal and may infrequently consist of~     gastroesophageal reflux. All caregivers will receive training on the use of a home monitor.~     Initial outpatient follow up will occur per unit standard and typically includes a nursing~     visit and a doctor visit within 2-3 days of discharge. Additionally, caregivers will be~     contacted via telephone within 2 days to answer any questions or address any concerns~     pertaining to apneic events, home monitor use, or caffeine therapy. Follow up in the~     pulmonary clinic will be arranged at 42-43 weeks gestational age at which time caregivers~     will be taught to determine the baseline frequency of monitor alarms on caffeine. At 43 weeks~     corrected gestational age, caregivers will be instructed to discontinue caffeine therapy and~     advised to contact the pulmonary clinic should alarm frequency increase. An outpatient~     recorded oximetry study will be arranged at least 1 week after discontinuation of caffeine~     therapy. Home pulse oximetry monitoring will be discontinued if no significant events are~     recorded. Caregivers will be asked to complete 3 brief questionnaires at enrollment, at 1~     month after discontinuation of the home monitor, and at 6 months of age. Each questionnaire~     will ask about topics such as satisfaction with hospital stay, quality of life, and numbers~     monitor alarms, acute care visits and/or rehospitalizations.~   "
88532|NCT02408315|"~     The primary objective of this study is to compare the efficacy and safety of vaginal and~     buccal misoprostol for women undergoing labor induction at greater than or equal to 37+ 0~     completed weeks gestation. Thus, the investigators have both efficacy and a safety primary~     outcomes.~      The secondary objective of this study is to assess the pharmacokinetic(PK) parameters with~     these two routes of administration in a sub-cohort of this trial. The long term objective of~     this line of research is to inform providers' clinical decision making for the large number~     of women having labor induction. By providing robust PK and pharmacodynamic (PD) evaluation,~     clinical outcomes data for these two routes of administration, clinicians will be informed~     for evidence-based decisions about the preferred route of administration of misoprostol.~   "
88533|NCT02408302|"~     Currently Midazolam sedation is the standard of care for minor invasive procedures in~     pediatric patients; its use is restricted to two routes of administration for this purpose~     oral and intranasal.~      A third route of administration (buccal) is tested and approved for seizure management. In~     the investigators' study the researchers investigate the buccal route of administration~     versus oral or intranasal administration for sedation. The investigators' hypothesis is that~     buccal route of administration is more convenient than intranasal and better absorbed than~     oral.~   "
88534|NCT02408289|"~     The purpose of this study is to determine whether high-flavonoid cocoa can decrease appetite~     in humans. In addition the study is designed to test epicatechin, a compound found in cocoa~     and procyanidins, a class of compounds found in cocoa, for their ability to decrease appetite~     in humans.~   "
88559|NCT02407951|"~     Tourette Syndrome (TS) is a disorder characterized by motor and vocal tics. The most studied~     and promising intervention is Habit Reversal Training (HRT) and its variations: Behavioral~     Comprehensive Intervention for Tics (CBIT). Group intervention for children with TS has not~     been evaluated. The aim of this study is to assess the efficacy of CBIT group intervention~     compared with Psycho-Educational-Supportive group in terms of tic severity.~   "
88535|NCT02408276|"~     Femoroacetabular impingement (FAI) is one of the most common mechanisms leading to the~     development of early cartilage and labral damage in the non-dysplastic hip. Anatomic~     abnormalities of the proximal femur and/or acetabulum result in repetitive injury during~     dynamic hip motion, leading to abnormal regional loading of the femoral head-neck junction~     against the acetabular rim. The resulting damage to the cartilage, labrum, and surrounding~     capsular structures predispose the patient to developing hip pain and early osteoarthritic~     changes. Clinically, patients with FAI are a heterogeneous group, with a wide array of~     presentation from pain to instability that may or may not be related to activity. To date no~     studies have identified specific prognostic indicators associated with successful surgical~     treatment of FAI, leaving surgeons without adequate criteria to determine which patients are~     best suited for arthroscopy. The investigators propose to address this critical knowledge gap~     by identifying the patient characteristics and morphological features of the hip that are~     associated with the optimal clinical outcomes in patients undergoing hip arthroscopy or~     non-operative management for treatment of suspected FAI in order to establish a treatment~     algorithm for FAI patients.~   "
88536|NCT02408263|"~     Pain has been defined as a subjective experience. Various pain assessment tools, (such as~     NRS) have been developed and validated to objectively monitor and treat pain. There are~     certain patient populations, in whom, the current pain assessment tools cannot be used~     effectively due to communication problems such as cognitively impaired patients. In the US,~     the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has made it~     mandatory to monitor and treat pain. In the absence of reliable pain assessment tools that~     would objectively measure pain, there is also risk of under treatment and overtreatment of~     pain that may lead to negative outcomes. Therefore, a monitor that is able to predict pain~     levels objectively, will help to achieve above goals. The investigators are using Skin~     Conductance Algesimeter (SCA) to measure pain by analyzing changes in skin conductance.~   "
88537|NCT02408250|"~     Practice guidelines recommend early physical therapy in intensive care unit. Feasibility,~     safety and efficacy are confirmed by growing evidence based data. However, the scientific~     literature emphasizes the heterogeneity of targeted populations, lack of precisions~     concerning eligibility criteria, program modalities, timing initiation, progressions and~     stopping criteria. However, all these results remain to be precised and confirmed. So, the~     investigators hypothesize that an early exercise program in intensive care unit formalized~     from a decisional algorithm is well tolerated in clinical practice.~   "
88538|NCT02408237|"~     Neuromodulation is characterized as a technique whose principle neurostimulation to produce~     inhibition or cortical arousal. The tDCS (transcranial direct current stimulation) is a~     noninvasive brain stimulation method used to modulate cortical excitability using low~     intensity direct current (1-2mA) directed to the scalp via cathodes and anodes electrodes;~     the current reaches the cortex, producing hyperpolarization or depolarization of the axonal~     membrane potential. Evidence has shown that this method is presented as a technique that can~     alter cortical and subcortical neural networks. This technique has been used to treat~     psychiatric disorders such as depression, acute mania, bipolar affective disorder panic,~     hallucinations, obsessive compulsive disorder, schizophrenia, withdrawal, rehabilitation~     after-stroke and pain syndromes such as neuropathic pain, migraine, pancreatitis chronic pain~     and fibromyalgia. It is low-cost technique, with virtually no side effects and carries the~     therapeutic effect by neuromodulatory pathways by distinct pathways activated by the drugs.~     In this scenario falls within the importance of developing devices for home use, inexpensive,~     and easy to use so as to maintain the benefits observed in previous studies. The tDCS is~     presented as a non-pharmacological option that may be offered in this context in society. It~     is noteworthy that, if the benefit is demonstrated, the impact will be of great importance to~     patients and to society, since these are focal techniques and low cost. Because they have no~     focal adverse effects of conventional drug treatments. Additionally, can be constituted as~     technical additive to pharmacotherapy in so much pain as in the treatment of other~     neuropsychiatric disorders. Therefore, further studies should be encouraged to increase~     knowledge of their effects and mechanisms involved. If the effectiveness of this method for~     home use is confirmed, the therapeutic impact will undoubtedly be of great importance.~     However, to make this project come true, the investigators depend on support for the~     development and validation of tDCS device for home use, so allowing the qualified knowledge~     can be applied to the clinical setting, as well as advance the development of this area of~     neuroscience in Brazil. Therefore, the aim of this study is to develop tDCS device for home~     use.~   "
88539|NCT02408224|"~     The TREASURE observational study is designed to address the need to understand the usage~     pattern of Ticagrelor in real life scenario in large number of ACS (Acute Coronary Syndrome)~     patients in India. The aim of this national study is to understand the usage pattern~     (including the duration of treatment) of Ticagrelor in various ACS patient population~     undergoing PCI (Percutaneous Coronary Intervention), CABG (Coronary Artery Bypass Graft) or~     medical management in a real-life setting in India.~   "
88540|NCT02408198|"~     This study aims to evaluate a novel group psychological intervention targeting anxiety~     triggered by urban environments for people with paranoia.~   "
88541|NCT02408185|"~     Phase II clinical trial, open-labelled, prospective and single-center study directed to~     obtain blood samples in experimental detailed conditions in order to compare and optimize the~     dose of colistin in critically ill patients suffering from infections on which the indication~     of colistin would be accepted according to normal local protocols for severe infections~     treatment.~   "
88542|NCT02408172|"~     Obstructive sleep apnea (OSA) is a highly prevalent chronic sleep disorder that affects 3% to~     7% in middle aged individuals and increases with age. OSA has been identified as the most~     common secondary cause associated with resistant hypertension. There is evidence that~     compared with older patients, the risk of hypertension in OSA patients may be particularly~     pronounced in younger adult ones (less than 50 years).~      Traditionally, cardiovascular risk stratification in hypertensive patients was based on the~     average blood pressure (BP) measured in the clinic. Accumulated data has shown that~     target-organ damage is related not only to 24-h mean intra-arterial BP, but also to BP~     variability (BPV) in subjects with essential hypertension. Growing evidence demonstrated that~     BPV has considerable prognostic value for all-cause mortality and cardiovascular outcomes,~     independent of average BP. In addition, it has been found that hypoxia condition in~     pneumoconiosis patients was closely associated with exaggerated BPV in ambulatory BP.~     However, the selections of antihypertensive drugs remain yet not very clearly for~     hypertensive patients combined with OSA.~   "
88560|NCT02407938|"~     Normal values for measurements of high resolution manometry in a protocol which includes~     isolated liquid swallows in upright and recumbent position, free drinking of water, a solid~     test meal and a postprandial observational period will be determined.~   "
88893|NCT02403570|"~     The aim of this study is to develop novel magnetic resonance imaging (MRI) protocols suitable~     for patients with multiple sclerosis using advanced MRI such as rotating frame relaxation~     imaging. In addition, the investigators want to study the correlation between advanced MRI~     parameters and clinical disease progression.~   "
88543|NCT02408159|"~     This study will evaluate the ability of the vaccine to produce antibodies against herpes~     zoster virus (shingles) and safety of vaccination with Varicella Zoster Vaccine in patients~     with moderate to severe psoriasis who will initiate biologic therapy 4 to 6 weeks after~     vaccination.~      Varicella Zoster Vaccine will be administered 4 to 6 weeks prior to receipt of biological~     therapy and will be compared against placebo.~      This double-blind study will enroll approximately 50 adult patients with moderate-to-severe~     plaque psoriasis in approximately 3 centers in Canada. Study products will be assigned~     randomly at a 4:1 ratio.~      For each patient who is included, the study may last up to 22 weeks, including the screening~     and the follow-up period. During the study, subjects will come to the dermatology clinic up~     to 4 occasions: for a screening visit, Baseline visit, Day 42 as well as 84 days after they~     started taking the biological treatment for a last visit. If patients develop a~     varicella-like or shingles-like rash at any time after they received the vaccine, they will~     be requested to come back to the clinic within 72 hours of rash onset (preferably within 24~     hours) for examination. Subjects will be asked to provide a lesion swab/vesicular fluid in~     this case.~   "
88544|NCT02408146|"~     The investigators hypothesized that using new intravenous infusion pump of patient-controlled~     analgesia (parecoxib sodium 1 mg/mL + normal saline) would significantly improve~     postoperative pain control compare to conventional intravenous infusion pump of~     patient-controlled analgesia (fentanyl citrate 20 mg/mL/kg + ondansetron hydrochloride 16~     mg/8 mL + normal saline). This prospective randomized controlled trial was designed to~     evaluate the benefit of new intravenous infusion pump of patient-controlled analgesia~     (parecoxib sodium 1 mg/mL + normal saline) for postoperative analgesia after laparotomic~     liver resection.~   "
88545|NCT02408133|"~     The purpose of this study is to evaluate the effectiveness of home exercise on quality of~     life and physical fitness of elderly women with breast cancer patients undergoing cancer~     treatment.~   "
88546|NCT02408120|"~     The purpose of this study is to test whether using extra doses of aspart insulin to correct~     blood sugars before meals improves the care of patients with type 2 diabetes in the hospital~     who are already receiving the standard of care treatment with glargine and aspart insulin~     injections to control blood sugar levels. Studies done in the past indicate that blood sugar~     levels are controlled on the standard treatment of insulin and that most patients do not need~     the small extra dose of insulin at bedtime. The investigators want to test if there is any~     benefit to giving patients extra doses of insulin during the day to correct the high blood~     sugars.~   "
88547|NCT02408107|"~     The aim of this current study was to investigate the effects of a pragmatic home-based~     physical activity programme on primarily physical activity levels and secondarily weight~     maintenance, health-related quality of life (HRQoL), insulin resistance (IR) and lipid~     concentrations in post-adjuvant therapy breast cancer survivors.~   "
88548|NCT02408094|"~     The purpose of this study is to explore the protein markers and to applicate those protein~     markers in syndrome diagnosis of hot-dampness and blood stasis syndrome in patients with RA.~   "
88549|NCT02408081|"~     The purpose of this study is to determine whether Family Focused Nursing are effective in the~     treatment of elderly medical patients with respect to prevalence of depression~   "
88550|NCT02408068|"~     The purpose of the study is to find out whether food has an effect on the way the body deals~     with modified release hydrocortisone, and to compare with the pharmacokinetics of immediate~     release hydrocortisone (fasted). This information will be used to help doctors with dosing in~     clinical practice.~   "
88551|NCT02408055|"~     A study to measure the absorption, metabolism and excretion of a single dose of radiolabelled~     TA-8995 (10mg) in healthy male subjects.~   "
88552|NCT02408042|"~     To determine the recommended phase 2 dose of chemotherapy in combination with Pembrolizumab~     in subjects with advanced lymphoma and determine the complete response rate.~   "
88553|NCT02408029|"~     This study is being performed to obtain data about the CORA System when used in a trauma~     clinical setting. The CORA analyzer is a new device that is currently being tested in trauma~     clinical applications and is not yet cleared for this purpose by the Food and Drug~     Administration (FDA) for sale in the United States.~   "
88554|NCT02408016|"~     This phase I/II trial studies the side effects and best dose of genetically modified T cells~     in treating patients with stage III-IV non-small cell lung cancer (NSCLC) or mesothelioma.~     Many types of cancer cells, including NSCLC and mesothelioma, but not most normal cells, have~     a protein called Wilms tumor (WT)1 on their surfaces. This study takes a type of immune cell~     from patients, called T cells, and modifies their genes in the laboratory so that they are~     programmed to find cells with WT1 and kill them. The T cells are then given back to the~     patient. Cyclophosphamide and aldesleukin may also stimulate the immune system to attack~     cancer cells. Giving cyclophosphamide and aldesleukin with laboratory-treated T cells may~     help the body build an immune response to kill tumor cells.~   "
88555|NCT02408003|"~     The investigators want to compare the effects of two drugs, levosimendan and milrinone, on~     cardiac muscle, both in terms of contractility and relaxation. Half of the participants will~     be randomized to each drug. The effects will be measured through echocardiographic~     deformation analyses.~      Since deformation analyses could be dependent on different loading conditions of the heart, a~     second purpose of the study is to investigate the changes on deformation parameters after~     applied changes in preload and afterload, but also heart rate.~   "
88556|NCT02407990|"~     This study will evaluate the safety, tolerability, pharmacokinetic profile and treatment~     effect of a new drug known as BGB-A317 in patients with advanced tumors.~   "
88557|NCT02407977|"~     This is an observational study. This protocol will determine the feasibility of using a novel~     nano-material based fiber-optic dosimeter (nanoFOD) device, with dimensions less than 1 mm~     wide, to measure real-time, pin-point, in-vivo radiation dose given during external beam~     delivery of radiation therapy treatments.This new protocol is similiar in design to~     Pro00050297 with the significant difference being the monitoring will be performed during~     external baem radiotherapy.~   "
88597|NCT02407457|"~     The objective of this post-market study is to evaluate Endologix AFX endovascular AAA system~     with anatomical fixation against other approved Endovascular systems with proximal fixation.~     Multiple U.S clinical centers will be involved in the study to include a broad range of~     experience. Imaging data will be evaluated by an independent core lab.~   "
88561|NCT02407925|"~     In this study, Dutch gastroenterologists who are certified for performing colonoscopies on~     FIT-positive patients in the Dutch population screening program are trained in optical~     diagnosis with validated methods. After this training, an ex- and in-vivo test phase leads to~     accreditation and endoscopists will be observed in their optical diagnosis for 1 year.~     During this year, half of the endoscopists will be randomized towards 3-monthly feedback and~     the other half will receive feedback on their results after 1 year. The endoscopic prediction~     of endoscopists on polyp histology will be compared to histopathological outcome.~   "
88562|NCT02407912|"~     To assess the effect and toxicity of intrapleural administration of hypertonic cisplatin for~     malignant pleural effusion in patients with non-small-cell lung cancer.~   "
88563|NCT02407899|"~     The main purpose of this study is to evaluate whether saxagliptin (and vitamin D3) with~     insulin therapy can better protect islet β cell function than insulin alone.~   "
88564|NCT02407886|"~     Transsynaptic degeneration of the retinogeniculate pathways is well documented to occur in~     nonhuman primates when the cerebral lesion occurs even during adulthood. In case of humans,~     retrograde transsynaptic degeneration of the retinogeniculate pathways has been shown to~     occur following prenatal or perinatal lesions, but its occurrence after cerebral lesions in~     adults is considerable rare. It is, however, well established that retrograde transsynaptic~     degeneration affects other neural systems in humans even when the injury occurs during~     adulthood. Some histopathological evidence points to the possibility of transsynaptic~     degeneration of the retinogeniculate pathway in humans even when the lesion occurs in adults,~     but the clinical significance is unknown.'~      Purpose:~      To measure the retinal ganglion cell layer (GCL) in patients with visual field defects due to~     intracerebral processes. To correlate GCL with the localization and type of intracerebral~     lesion.~      To compare the GCL with the retinal nerve fibre layer (RNFL) to investigate, which of the 2~     parameters is more sensitive to show retinal layer abnormalities.~      To correlate GCL with visual field defects and electrophysiological parameters.~   "
88565|NCT02407873|"~     The score on the Edmonton frail scale will be recorded in 250 consecutive patient aged of 75~     years or more and undergoing elective cardiac surgery. In those patients the investigators~     will also record the ITU length of stay, the hospital length of stay, the incidence of~     complications, the ability to be discharged home and to live independently at postoperative~     day 30.~      The ability of the Edmonton score to predict complication, prolonged hospital and ITU length~     of stay as well as loss of autonomy at discharge and day 30 will be assessed.~   "
88566|NCT02407860|"~     Breastfeeding is the physiological and recommended way of feeding newborns as indicated by~     the World Health Organization, Health Canada and the politics of perinatality 2008-2018 in~     Quebec. Despite these, mothers who exclusively breastfed their babies are rare. According to~     Statistics Canada, the first month of life is the most at risk time to wean because of~     technical difficulties (53% of weaning) including mechanical issues. In Quebec city, despite~     a supportive network of health care professionals including lactation consultant, many babies~     are weaned. Lactation consultant are often feeling helpless when facing these mechanical~     difficulties.~      The purpose of this study is to determine the efficiency of an osteopathic treatment for~     newborns presenting breastfeeding mechanical difficulties. The investigators' hypotheses is~     that an osteopathic treatment integrating in the usual care is more efficient than usual car~     alone to help healing mechanical breastfeeding issues.~      The investigators propose a randomized clinical trial on a sample of 90 babies (45 in each~     group), under six weeks, presenting sucking dysfunctions, in Quebec city (Canada). The~     control group will receive usual care with a lactation consultant and the intervention group~     will receive usual care plus an osteopathic treatment. It is a simple blind clinical trial:~     the osteopath finds out, prior to evaluating the patient, what intervention should be~     delivered to the baby (assessment alone or standardized osteopathic treatment for infant).~      The results will ultimately lead to improvements in the existing knowledge on the fields of~     osteopathy and lactation support, allowing implementation of osteopathic care in the~     perinatal network.~   "
88567|NCT02407847|"~     The aim of this study is to explore the effects of substitution in out-of-hours primary care.~     In consecutive stages an extra General Practitioner (GP) is substituted by a Nurse~     Practitioner (NP) aiming at replacing 3 out of 4 GPs by NPs. Effects are measured in terms of~     feasibility and cost-efficiency.~   "
88568|NCT02407834|"~     This clinical trial evaluated Ricinus communis and sodium hypochlorite solutions in different~     concentrations for denture cleanliness, regarding biofilm removal capacity, remission of~     atrophic chronic candidiasis, degree of patient satisfaction and antimicrobial action against~     specific microorganism. Sixty-four denture wearers with absence (n=40) or presence of~     Candidiasis (n=24) were selected and oriented to brush their dentures with a specific brush~     and neutral soap for 3 minutes, 3 times a day and immerse them, once a day, in hygiene~     solutions (0.25% sodium hypochlorite - S1 and 0.5% - S2, 10% R. communis - S3; Saline - S4:~     control) during 20 minutes, for 7 days. The solutions were used in a randomized, double blind~     and cross form with washout periods. To quantify biofilm with software ImageTool 3.0, the~     inner surface was disclosed (1% neutral red) and photographed at the end of each period. The~     Candidiasis remission was assessed by scores before and after the use of solutions. Patient~     satisfaction was assessed by questionnaire. Antimicrobial activity was determined by Colony~     Forming Units (CFU) counts of Streptococcus mutans, Candida spp., and gram-negative~     microorganisms. For collecting biofilm, internal surface of each maxillary complete denture~     was brushed with saline solution, and the biofilm suspension obtained. After serial dilutions~     (100 - 10-3), 50 uL aliquots were seeded in Petri dishes containing Mitis salivarius agar~     base, CHROMagar Candida® and MacConkey agar for detecting S. mutans, Candida spp., or~     gram-negative microorganisms, respectively. After incubation, colonies were counted, and~     values in CFU/mL were calculated. Biofilm removal was analyzed as a split-plot with two~     variation factors: inflammation and solutions. The candidiasis remission was analyzed after~     adjustment using multinomial logistic regression. Logistic regression analysis and compound~     symmetry was adopted for patient satisfaction. The antimicrobial action was analyzed with~     Friedman´s test. Antimicrobial action data were processed after transformation - log10 (CFU +~     1) - and were analyzed by Friedman test (α = 0.05).~   "
88569|NCT02407821|"~     In this study the investigators hypothesize that antidepressant therapy may improve the~     overall welling of patients with acute or chronic kidney disease when given around the time~     of starting chronic dialysis therapy. This study is a pilot, randomized controlled trial that~     aims to examine whether prescribing oral escitalopram to all incident dialysis patients is~     safe and feasible.~   "
88570|NCT02407808|"~     The overarching goal of this study is to characterize the effects of cannabinoids on working~     and episodic memory.~   "
88571|NCT02407795|"~     A randomized, multicentre, phase III study comparing conventional radiotherapy (1x8Gy) with~     stereotactic radiotherapy (1x20Gy) for pain reduction and quality of life in spinal~     metastases.~   "
88574|NCT02407756|"~     The primary objective of the study is to characterize the safety and pharmacokinetics (PK) of~     dupilumab in pediatric patients with moderate-to-severe atopic dermatitis (AD) (for~     adolescents ≥12 to <18 years of age) or severe AD (for children ≥6 to <12 years of age).~      The secondary objective of the study is to explore the immunogenicity and efficacy of~     dupilumab in pediatric patients with moderate-to-severe AD (for adolescents ≥12 to <18 years~     of age) or severe AD (for children ≥6 to <12 years of age).~   "
88575|NCT02407743|"~     The purpose of this research study is to determine what causes pain after surgery to increase~     or decrease over time.~   "
88576|NCT02407730|"~     Both hereditary and acquired thrombophilia have been associated with recurrent miscarriage~     and pregnancy complications. Thrombophilia could favor the development of thrombosis of the~     maternal vasculature and obstacle placentation. Some studies have suggested a role of~     thrombophilia in the failure of assisted reproductive techniques although this association~     has been recently questioned. The scope of this study is to evaluate the effect of~     thrombophilia on the implantation rate and live birth rate in women undergoing ART.~      Design: prospective, observational study Primary end-point: live birth rate. Secondary~     end-points: implantation rate, venous thromboembolic events during ART up to 6 weeks~     post-partum~   "
88577|NCT02407717|"~     Patients with cancer hospitalized for an acute medical illness have an increased risk of~     venous thromboembolic events. Although international guidelines suggest the use of~     thromboprophylaxis in these patients, the recommendations are based on studies which included~     a percentage of patients with cancer without primarily focusing on this high risk group.~      Since patients with cancer present an increased risk of bleeding complications it is critical~     to evaluate the safety of thromboprophylaxis in the cancer group. Recent studies suggest a~     limited use of thromboprophylaxis in these patients.~      The aim of this study is to evaluate the use, efficacy and safety of thromboprophylaxis in~     medical cancer patients hospitalized for an acute medical disease.~      Design: observational, prospective study Primary end-point: incidence of major and clinically~     relevant non major bleeding during hospitalization Secondary endpoints: frequency of use,~     doses and contraindications for pharmacological thromboprophylaxis; venous thromboembolic~     events up to three months after discharge~   "
88578|NCT02407704|"~     This pilot study aims to test a model that predicts that enhanced neurotransmitter~     gamma-aminobutyric acid (GABA) function in reward and affect-regulation central nervous~     system (CNS) circuits mediates the antidepressant effects of exercise. State-of-the-art~     magnetic resonance (MR) imaging, cognitive assessment, accelerometry, genetic, and~     inflammatory biomarkers will be acquired through the coordination of efforts from several~     established research programs at Western Psychiatric Institute and Clinic. This pilot study~     will be used as a platform for testing a causal/mediating role of GABA interneurons in reward~     processing and affect regulation in humans. This pilot study is not powered for testing a~     full causal model, but rather is intended to test overall feasibility of the intervention and~     acquisition of measures (see specific aim 1 below). This is a necessary prerequisite for~     designing a larger more definitive study of the model, which will be a component of a future~     grant application. Additionally, the data from this study will be used to test the clinical~     efficacy of exercise as an adjunctive treatment for late life depression (LLD; Specific Aim~     2), as well as imaging, cognitive, and sleep aims (Specific Aims 3 and 4).~   "
88579|NCT02407691|"~     With increasing access to antiretroviral therapy (ART) in South Africa, HIV has transitioned~     from a terminal illness to a long-term condition. It is likely to be accompanied by higher~     levels of disability and other chronic non-communicable diseases, resulting from the HIV~     itself, as well as adverse effects of medication. This requires an expansion of the purview~     of HIV care beyond direct HIV clinical care to also include a more comprehensive and~     integrated package of treatment and care for physical and mental conditions and their~     consequences. COBALT is a pragmatic cluster randomized controlled trial (RCT) in public~     sector primary care clinics in the North West Province of SA. It will assess mental health~     and HIV outcomes for depressed adults receiving ART by measuring the real-world effectiveness~     of a facility-based stepped care intervention combining depression case detection by~     non-physician clinicians with group counselling intervention delivered by lay-health workers.~   "
88580|NCT02407678|"~     The assessment of the efficacy (with respect to preservation of visual function and retinal~     structure) and safety of a single subretinal injection of AAV2.REP1 in participants with a~     confirmed diagnosis of choroideremia, as evaluated by various functional and anatomical~     outcomes measured over a number of time points up to 24 months post-treatment.~   "
88581|NCT02407665|"~     This exploratory study proposal is the first pilot brain imaging study to determine if Tai~     Chi can modulate brain resting state functional connectivity (rsFC) and brain morphometry~     among fibromyalgia (FM) patients and healthy controls.~   "
88582|NCT02407652|"~     The purpose of this study is to explore the effectiveness of an internet-delivered cognitive~     control training as a preventive intervention for remitted depressed patients.~   "
88583|NCT02407639|"~     Studies in adults have shown that post-procedural abdominal pain is reduced with the use of~     CO2 instead of air for insufflation during colonoscopy. The aim of our study is to compare~     post-procedural abdominal pain and girth in children undergoing colonoscopy using CO2 or air~     for insufflation.~   "
88584|NCT02407626|"~     This study evaluates the myocardial protection against perioperative ischemia comparing two~     standard anesthetic regimes in diabetic patients undergoing elective cardiac surgery. Half of~     the patients will receive volatile anesthesia while the other half will receive total~     intravenous anesthesia. Primary and secondary outcome parameters will be assessed after~     induction of anesthesia, at the end of the procedure and postoperative day 1 to 3.~   "
88585|NCT02407613|"~     This study evaluates the efficacy of MR-HIFU ablation of breast cancer. Ten patients with~     early-stage breast cancer with a maximum diameter of 3 cm undergo MR-HIFU ablation, followed~     by MRI and surgical resection to evaluate treatment effect. The main purpose of the study is~     to demonstrate the feasibility of total tumor ablation with MR-HIFU. The secondary objective~     is safety assessment.~   "
88586|NCT02407600|"~     This study evaluates the addition of fosaprepitant to currently available antiemtic~     treatments of carboplatin chemotherapy-induced nausea and vomiting in advanced non-small cell~     lung cancer patients. Half of the patients will receive fosaprepitant in their first~     chemotherapy cycle, and a placebo on their second chemotherapy cycle. The other half of the~     patients will begin their first chemotherapy cycle.~   "
88587|NCT02407587|"~     Investigators hope to study patients with 1 cochlear implant and who have had hearing~     preservation surgery and compare the changes in the brain of these patients with normal~     hearing patients by doing a scan of the brain when listening to speech. The information~     investigators collect may help investigators to understand how the brain learns to hear with~     a cochlear implant and whether it uses the same areas in the brain to listen as in normal~     hearing patients as well as predict which patients will do well with a cochlear implant as a~     very specialised operation is needed to insert the cochlear implant in to the ear and is done~     by very few surgeons in the country. After the operation, patients need several months of~     teaching to help them learn how to hear through the implant. Having a cochlear implant~     requires a lot of cooperation and time from the patient and if investigators could understand~     how the brain learns to hear with a cochlear implant and predict which patients do well and~     why then we may be able to avoid unnecessary procedures.~   "
88588|NCT02407574|"~     The aim of the study is to determine whether increasing the heart rate by epicardial atrial~     pacing after surgery improves the contractile force of the myocardium. After complete weaning~     from CPB, several pressure-loops of the LV will be recorded at different levels of preload~     using transoesophageal echo, invasive blood pressure monitoring. The preload will be~     manipulated by adding fluid from the CPB reservoir or draining fluid into the CPB reservoir.~   "
88589|NCT02407561|"~     Patients with locally advanced rectal and esophageal carcinomas typically undergo neoadjuvant~     chemoradiation therapy prior to surgical resection. While response rates to this treatment~     differ among these three cancers, generally 20-25% of patients exhibit minimal or no response~     to preoperative chemoradiation therapy while 20-30% exhibit a complete pathologic response,~     and the remainder receiving a partial response.~      This will be a multi-center study of patients with newly diagnosed rectal adenocarcinoma, or~     anal squamous cell carcinoma (SCC) who will undergo neoadjuvant chemoradiation prior to~     surgery. The tumor from these patients will be tested to determine whether response to~     neoadjuvant chemoradiation can be accurately predicted.~   "
88590|NCT02407548|"~     In previous study the investigators found that CoQ10 can improve cholesterol efflux from~     macrophages in cell model, ApoE mice model and small-scale of healthy volunteers. In~     addition, CoQ10 has strong antioxidant activity and is an essential factor of mitochondria~     electron transport chain. So the investigators hypothesize that CoQ10 may have some health~     promotion effect on dyslipidemia, risk factor of atherosclerosis and other cardiovascular~     diseases. On this purpose, the investigators are going to recruit 150 dyslipidemia patients~     to supply CoQ10+vitamin E or CoQ10 alone or placebo in different doses for 24 weeks to~     explore the effects of CoQ10 on cholesterol efflux and lipid profiles on dyslipidemia.~   "
88591|NCT02407535|"~     In this study the investigators aim to assess the diagnostic performance of intraoperative,~     ultrasonographic assessment of the surgical extracted uterus for determining myometrial~     invasion's depth in comparison to preoperative ultrasound, intraoperative gross inspection~     and final pathological report (gold standard). The investigators hope that intraoperative~     gross inspection of the extracted uterus might offer an additional intraoperative tool for~     assessing the need for pelvic lymphadenectomy in early stage of endometrial cancer at least~     as good as pathological exam.~   "
88592|NCT02407522|"~     The purpose of this study is to thoroughly investigate how the interaction between black rice~     and human gut microbiota affects metabolic diseases, this study will recruit patients with~     Metabolic Syndrome (MS) and provide them with dietary supplementation of black rice (50~     g/day) for 3 months to observe its effect on the development of MS. The focuses of this~     project are to elucidate how black rice consumption affects the composition and metabolism of~     intestinal bacteria as well as the development of MS, and to further analyze whether the~     changes in intestinal bacteria are associated with the changes in MS improvements.~   "
88593|NCT02407509|"~     RO5126766 will be administered initially as a single daily dose of 4mg using either a twice~     weekly dosing schedule (Monday-Thursday) or a 3 times per week dosing schedule~     (Monday-Wednesday-Friday). The daily dose will be given orally according to the dosing~     schedule. A cycle of treatment will comprise 28 days. In Part I of the study both the twice~     weekly and the three times per week schedules will be assessed. In the absence of dose~     limiting toxicities 6 patients will be recruited to each dosing schedule cohort. In the event~     of a DLT being observed in Part I of the study, a single dose reduction to 3.2 mg will then~     be instigated and up to 6 patients will be recruited to that dosing schedule at the lower~     dose. The optimal dosing schedule determined in Part I will be taken forward to Part II and~     20 patients with tumours harbouring BRAF, KRAS and NRAS mutations will be enrolled.~   "
88594|NCT02407496|"~     The purpose of this study is develop a new assessment tool for Attention~     Deficit-Hyperactivity Disorder (ADHD) and to then test its validity (i.e. ability to~     discriminate between individuals with ADHD and healthy controls).~   "
88595|NCT02407483|"~     Laparoscopic simulation training with or without laser visual guidance -A randomised study~     which investigates if the use of laser visual guidance can help the novices to learn the~     laparoscopic skills.~   "
88596|NCT02407470|"~     RATIONALE: It has been shown that about 30% of patients do not respond to immunosuppressive~     therapy or experience recurrence, and graft rejection and graft-versus-host-disease (GVHD)~     decrease event-free survival to 30% to 50% in the alternative donor (matched unrelated,~     partially matched family member) transplantation. Although an overall and disease free~     survival of 85% to 100%, can be obtained in allogeneic blood or bone marrow stem cell~     transplantation using an human leukocyte antigen (HLA) matched sibling donor, only about 25%~     of patients have such a donor.~      PURPOSE: In an attempt to avoid GVHD, reduce earlier infection rate and decrease~     regimen-related toxicity while maintaining better engraftment, this study is to evaluate the~     effectiveness and safety of patient's own adipose-derived mesenchymal stem cell (AD-MSC) or~     AD-MSC transdifferentiated HSC (AD-HSC) transplant after an immunosuppressive regimen in~     treating patients who have severe aplastic anemia.~      The patient will be in the study for one year for observation and active monitoring. After~     treatment and active monitoring are over, the patient's medical condition will be followed~     indefinitely. The principle measures of safety and efficacy will be :~        1. Patient survival probability at 3 months, 6 months and 1 year.~        2. Engraftment at 3 months, 6 months and 1 year~        3. Incidence of graft versus host disease (GVHD), incidence of acute and chronic GVHD and~          Incidence of earlier infection rate as well as other complications within 6 months and 1~          years.~   "
88600|NCT02407418|"~     The purpose of this study was to investigate the effects of chiropractic low back adjustments~     on thigh muscle strength. Force production was measured during different types of muscle~     contractions with a device called an isokinetic dynamometer. The study included 21~     college-aged subjects who did not have any pain and had never received chiropractic treatment~     with spinal manipulation. During two separate sessions, subjects' thigh muscle forces were~     recorded while performing maximal muscle contractions on the isokinetic dynamometer. Baseline~     measurements of muscle force were acquired before either treatment form of spinal~     manipulation or a sham spinal manipulation, followed by identical muscle force measurements~     within five and twenty minutes post-treatment.~   "
88601|NCT02407405|"~     This phase II trial studies how well selumetinib works in treating patients with~     neurofibromatosis type 1 and plexiform neurofibromas (tumors which arise from the nerves)~     that cannot be removed by surgery (inoperable). Selumetinib may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth.~   "
88602|NCT02407392|"~     Problem statement Barrett's oesophagus is a pre-cancerous condition affecting 375,000 people~     in the U.K. There is a 0.5-3% yearly risk of progressing to oesophageal cancer, from which~     only 5% of patients will survive for 5 years after diagnosis. Diagnosing the disease at the~     stage of dysplasia (pre-cancerous) and early cancer improves survival. This has led to the~     current surveillance strategy of gastroscopy with non-targeted mapping biopsies taken from~     the Barrett's oesophagus every two years. The large number of biopsies required is time~     consuming and expensive, yet dysplasia and cancerous tissue is still missed due to the~     non-targeted biopsy sampling strategy. Acetic acid has been used effectively in the early~     detection of cervical dysplasia and cancer, and has also been used with success in a high~     risk Barrett's population (patients with suspected dysplasia or previously treated~     dysplasia), but not been studied in the lower risk Barrett's surveillance population. A~     diagnostic study of non-targeted mapping biopsies (current practice) versus targeted biopsies~     (acetic acid) in a surveillance population is needed before widespread adoption of this~     technique is possible.~   "
88603|NCT02407379|"~     The purpose of this study is to compare the efficacy of photoablative and photodynamic diode~     laser in adjunct to scaling-root planing (PAPD+SRP) and SRP alone for the treatment of~     periodontitis.~   "
88604|NCT02407366|"~     The current standard of care for unresectable locally advanced non-small-cell lung cancer~     (NSCLC) is a combination of chemotherapy and thoracic radiotherapy (TRT). The standard~     regimens consist of platinum-based doublet chemotherapy.Icotinib(BPI-2009, Conmana) is the~     first self-developed small molecular drug in China for targeted therapy of lung~     cancer.Icotinib is a novel oral quinazoline compound that has proven survival benefit in~     Chinese patients with lung cancer,especially in EGFR mutation lung cancer. This randomised,~     multi-center, controlled trial is designed to assess the efficacy and safety of icotinib with~     concurrent radiotherapy versus pemetrexed + carboplatin with concurrent radiotherapy in~     inoperable stage III non-small cell lung cancer with EGFR mutation, the primary endpoint is~     progression-free survival.~   "
88605|NCT02407353|"~     This is phase 1 investigator-and-subject blind, sponsor open, randomized, placebo controlled,~     parallel study in healthy subjects to evaluate the pharmacodynamics effect of single oral~     doses of PF-06648671 on CSF Aβ concentrations using serial CSF sampling methodology.~   "
88606|NCT02407340|"~     This study will examine the utility of the neuropeptide oxytocin (OT) as a potential new~     medication for the treatment of Alcohol use disorder (AUD). Non-treatment seeking men and~     women with AUD will be enrolled in a double blind placebo controlled phase I clinical trial.~     Participants will complete an 7-day inpatient protocol. During the first 3 days of the~     inpatient protocol, participants will complete alcohol abstinence in which withdrawal~     symptoms are measured,and urine will be collected to determine withdrawal symptom severity~     and urine levels of the stress hormone cortisol. Participants will then complete 3 laboratory~     procedures which measure 1) stress response, 2) motivation to drink alcohol and 3) subjective~     and physiological effects of alcohol. Finally, because participants are individuals with AUD,~     investigators will administer a brief intervention to address their risky alcohol drinking~     and problems before discharge.~   "
88607|NCT02407327|"~     The purpose of this study is to determine the percentage of CTC-positive patients and total~     CTC numbers in patients with advanced Non Small Cell Lung Cancer .~   "
88608|NCT02407314|"~     This is an interventional study assessing the effectiveness of Ticagrelor on the reduction of~     thrombus burden using optical coherence tomography in patients undergoing peripheral artery~     stenting.~   "
88609|NCT02407301|"~     This project is a first attempt to assess cough airflow dynamics and true vocal fold (TVF)~     adduction and abduction angles during voluntary cough to examine the effects of changes in~     glottal closure due to reduced mobility of one true vocal fold. The hypothesis of this study~     is that the incomplete glottal closure due to reduced vocal fold mobility will result in~     changes in true vocal fold adductory and abductory angles during cough and will result in~     changes to voluntary cough airflow parameters. This study results will contribute to the~     existing knowledge of the laryngeal contribution to cough airflow dynamics.~   "
88610|NCT02407288|"~     The purpose of this study is to determine whether tDCS is effective as an add-on treatment in~     SSRI-resistant patients with obsessive and compulsive disorder~   "
88611|NCT02407275|"~     To analyse and describe sinus microbiota, during hard to treat (or refractory)~     rhinosinusitis, using culturomic and metagenomic methods (i.e. to culture on many different~     medium of culture to grow hard to cultivate bacteria + to sequence and analyse all DNA~     contained in samples).~      Samples are middle meatus swabs or pus aspiration, done during usually patient following.~   "
88625|NCT02407093|"~     Although soldiers must be ready to respond to occupational and war theatre demands at a~     moment's notice, there is an epidemic of overweight and obesity and a need for improved~     fitness and health in the military. Using a cluster randomized clinical trial we propose to~     test the effectiveness of a High-Intensity Functional Training (HIFT) exercise intervention~     to improve the body composition and fitness of active duty military personnel. The~     effectiveness of the HIFT intervention will be compared to usual Army Physical Readiness~     Training. Main outcomes will include changes in body composition and traditional fitness~     measures, a test of combat-preparation, and measures of cardiovascular health risk for both~     groups.~   "
88612|NCT02407262|"~     Traditionally, Black Seed (Nigella sativa) is a well-known food supplement and herbal product~     that has a wide range of medical claims (including asthma) that originate from different~     historical backgrounds. Today in the era of Evidence-based medicine, it is hard to accept~     those traditional medical claims of medicinal plants without valid scientific experiments.~     Thus, randomized clinical trials is important to rational the uses of herbal products.~      Asthma is a common chronic disorder of the airways, characterized by variable reversible and~     recurring symptoms related to airflow obstruction, bronchial hyper-responsiveness, and~     underlying inflammation. In Saudi Arabia, Asthma is considered one of the leading chronic~     diseases affecting more than 2 million Saudi citizens. The global Asthma Report 2014~     considered Asthma as an epidemic disease probably affecting about 334 million people~     worldwide and becoming a global health priority.~      This project investigates the use of herbal products to enhance asthma control in Saudi~     Arabia. In this context, Black Seed is one of the common herbal products used traditionally~     for asthma in the Saudi region. Black seed is a common unconventional therapy used among 10%~     of Asthmatic patients in King Abdulaziz Medical city, Riyadh. In fact, there are some~     pre-clinical evidence and preliminary clinical studies support the usefulness of Black seed~     in Asthma and its underlying causes~   "
88613|NCT02407249|"~     This is a control registry to the E-FIRM registry to track conventional atrial fibrillation~     (AF) procedures in terms of clinical usage, handling, and the safety and effectiveness for~     the treatment of symptomatic atrial fibrillation. Conventional AF ablation is defined as~     pulmonary vein isolation (PVI) and any additional ablation for AF according to the standard~     routine of the center.~      Data items will be collected, if available, consistent and applicable with routine and~     standard clinical care at each participating site.~   "
88614|NCT02407236|"~     The purpose of this study is to evaluate the efficacy and safety of ustekinumab as~     intravenous (IV: into the vein) infusion in induction study in participants with moderately~     to severely active Ulcerative Colitis (UC) and as subcutaneous (SC) administration in~     maintenance study in participants with moderately to severely active Ulcerative Colitis (UC)~     who have demonstrated a clinical response to Induction treatment with IV ustekinumab.~   "
88615|NCT02407223|"~     The purpose of this study is to assess the efficacy and safety of ustekinumab in adult~     participants with active nonradiographic axial spondyloarthritis (nr-AxSpA) measured by the~     reduction in signs and symptoms of nonradiographic axial spondyloarthritis (nr-AxSpA).~   "
88616|NCT02407210|"~     To investigate the efficacy and safety of azilsartan compared to olmesartan medoxomil in~     patients with grade I or II essential hypertension~   "
88617|NCT02407197|"~     Myocardial fibrosis is the fundamental substrate for the development of heart failure.~      Cardiovascular magnetic resonance (CMR) allows non-invasive assessment of myocardial fibrosis~     based on late gadolinium enhancement (LGE) and T1 mapping.~      Patients: Prospective longitudinal observational multicenter study of consecutive patients~     with suspected or known non-ischemic cardiomyopathy.~      Imaging: Non-invasive measures of myocardial fibrosis: native T1, extracellular volume~     fraction (ECV) and LGE.~      Primary endpoints: all cause and cardiovascular mortality.~      Secondary endpoints: arrhythmic composite and HF composite endpoints.~   "
88618|NCT02407184|"~     Understanding the microbiome's important role in human health, the investigators wish to~     determine how the development of the infant microbiome is impacted by delivery mode,~     comparing natural vaginal birth to scheduled C-sections. Investigators will look at the oral,~     nasal, skin, vaginal and fecal bacteria of 78 mothers and their infants from birth to age 1.~   "
88619|NCT02407171|"~     This is a 2-part prospective trial examining the ability of Stereotactic Body Radiation~     Therapy (SBRT) to induce a response to MK-3475, a humanized antibody to PD-1, in patients who~     progress on this antibody. Patients with metastatic melanoma will be enrolled after they have~     progressed on anti-PD-1 therapy. Patients with metastatic NSCLC (previously untreated with~     anti-PD-1 or anti-PD-L1 therapy) will be enrolled and treated with MK-3475 until they exhibit~     progression of disease. At this point (when patients have demonstrated progression of~     disease) a single target lesion will be selected and treated with SBRT, and then MK-3475 will~     be restarted and continued until there is further progression of disease. The first phase of~     the study is a radiation dose escalation with a constant dose of MK-3475. The second part of~     the study includes expansion cohorts of NSCLC and melanoma patients.~   "
88620|NCT02407158|"~     The investigators will compare the response to oral endotracheal tube repositioning as~     measured by chest x-ray and measured by the air-wave device.~   "
88621|NCT02407145|"~     This study is designed to evaluate the safety and efficacy of low elasticity polyvinylidene~     fluoride (DynaMesh®-SIS soft) retropubic tension-free midurethral slings in the treatment of~     stress urinary incontinence in women. Women who are having a retropubic PVDF midurethral~     sling for urodynamic stress incontinence will be followed up for 24 months to address its~     efficacy and rate of complications.~   "
88622|NCT02407132|"~     The investigators will conduct a comparative effectiveness evaluation using a randomized~     control trial design of the adapted Family Model of Diabetes Self-Management Education~     (DSME), and compare results of the Family Model of DSME with traditional DSME within the~     Marshallese population. The family model will cover the same concepts as the traditional~     format. However, the family model will incorporate culturally-adapted education and~     recommendations aimed at engaging family members in the management of the primary~     participant's diabetes, and family members will be invited to fully participate in the study.~     By contrast, the traditional model provides diabetes self- management education to the~     diabetic participant only, and the participant's family members do not participate in the~     classes or any other part of the study. Biometric and survey data will be collected~     pre-intervention, post-intervention, 6 months post-intervention, and 12 months~     post-intervention. A qualitative debriefing session will be held for each family between the~     final DSME session and the 6 month post-intervention to obtain qualitative data regarding the~     participant's perceptions of the intervention and implementation process.~   "
88623|NCT02407119|"~     This study evaluates whether Helicobacter pylori eradication improves precancerous lesions~     including glandular atrophy and intestinal metaplasia as well as metachronous cancers or~     dysplasias after endoscopic mucosal resection for gastric cancer.~   "
88624|NCT02407106|"~     The purpose of this study is to determine whether daily treatment with Streptococcus~     Salivarius BLIS K-12 prevents streptococcal throat infection in children that have had an~     episode of rheumatic fever.~   "
88626|NCT02407080|"~     This research looks at two conditions, Essential Thrombocythemia (ET) and Polycythemia Vera~     (PV). ET causes people to produce too many blood cells called platelets and PV causes too~     many platelets and red blood cells to be made. Platelets are particles which circulate in the~     blood stream and normally prevent bleeding and bruising. Having too many platelets in the~     blood increases the risk of developing blood clots, which can result in life threatening~     events like heart attacks and strokes. When the number of red blood cells is increased in PV~     this will slow the speed of blood flow in the body and increase the risk of developing blood~     clots.~      The purpose of Part A of this study is to test the safety and tolerability of drug RG7388~     patients and identify the recommended phase II dose in a single agent dose escalation study.~     The investigators want to find out what effects, good and/or bad it has on the disease.~      The purpose of Part B of this study is to test the safety and tolerability of the combination~     of RG7388 and Pegylated Interferon Alfa-2a or Pegasys in PV/ET patients from Part A who did~     not achieve at least a partial response by the end of three cycles of single agent RG7388.~      Essential Thrombocythemia (ET) and Polycythemia Vera (PV) have been difficult diseases to~     treat. RG7388 is a selective inhibitor of the p53-MDM2 binding that frees p53 from negative~     control and activates the p53 pathway in cancer cells, leading to cell cycle arrest and~     apoptosis in vitro and in vivo. It has been used to treat solid tumors and Acute Myelogenous~     Leukemia (AML) in clinical trials. Pegasys is a drug that is the standard of care for~     patients who have Chronic Hepatitis B (CHB).~      RG7388 is a drug that is not yet approved by the Federal Drug Administration (FDA) for the~     treatment of patients with essential thrombocythemia or polycythemia vera. Pegasys is a drug~     that is approved by the FDA for the treatment of CHB. The use of RG7388 alone and in~     combination with Pegasys is experimental.~   "
88627|NCT02407067|"~     This study will compare two types of assistive devices for communication (a voice amplifier~     and a personal communication system) in individuals with a speech disorder related to~     Parkinson's disease. The performance of these two devices will be examined with measures of~     speech intelligibility and patient questionnaires and rating scales.~   "
88628|NCT02407054|"~     The main purpose of this study is to evaluate the safety and effectiveness of the study drug~     known as LY3023414 in combination with enzalutamide in men with prostate cancer.~   "
88629|NCT02407041|"~     Study GT-030 is a phase 2a, single-center, open-label study of subjects with moderate to~     severe plaque psoriasis~   "
88630|NCT02407028|"~     The purpose of this innovative adaptive phase II trial design is to determine the optimal~     combination of hyperbaric oxygen treatment parameters that is most likely to demonstrate~     improvement in the outcome of severe TBI patients in a subsequent phase III trial.~   "
88631|NCT02407015|"~     This study aims to examine the specific effect that 3D game play has on the control of the~     eyes horizontal movements. It will examine the youngest group of consumers this technology is~     marketed to, 7 to 11-year-olds and no children under 7 years of age will be recruited to this~     study as per Nintendo's hardware guidelines, which recommends that children under 7 years of~     age not play in 3D mode. It will examine the effect of playing in 3D for 30 minutes on~     horizontal fusional amplitudes compared with a control group playing in 2D for 30 minutes.~   "
88632|NCT02407002|"~     The purpose of this study is to quantify the risk of hypotension due to field treatment with~     nitroglycerin in patients with ST-elevation myocardial infarction, particularly right~     ventricular infarcts, and secondarily to evaluate the benefit to pain relief..~   "
88633|NCT02406989|"~     This is a randomized, double-blind, placebo-controlled, multiple-ascending dose study of~     MS-553 in healthy volunteers. Endpoints are safety, tolerability, and pharmacokinetics.~     Subjects are dosed for 14 days.~   "
88634|NCT02406976|"~     This objective study to verify the effect of physical training with and without behavioral~     cognitive therapy, compared with controls, in functional capacity and cardio-metabolic~     profile in individuals with morbidly obese~   "
88635|NCT02406963|"~     A pilot research study is planned to occur within the pediatric urology service the spring of~     2015. All pediatric urology patients in the immediate post-operative period of 0-14 days will~     be eligible for this study. This study will compare the current standard of care for managing~     post-operative complications (a telephone conversation with the NP) versus an experimental~     intervention (telephone call and an electronic photograph of the surgical site). Before the~     surgical patient is discharged from the hospital, consent will be obtained for participation.~     Once a family initiates contact with the NP with a post-operative concern they will be~     randomized to either the control or the experimental group. Those in the control group will~     receive the current standard of care, which is telephone advice only. Those in the~     experimental group will speak to the NP on the telephone and will be requested to send an~     electronic photograph of their child's surgical site to the NP for assessment and advice.~     Photographs will be assessed using a standardized tool by both NPs and this information will~     be entered into a database. The investigators will be measuring the number of emergency~     department (ED) and/or unplanned clinic visits in both groups. An unplanned clinic visit is~     defined as a visit that is required due to an unexpected complication or concern before the~     original scheduled post-operative follow-up as determined by the surgeon. The investigators~     will be tracking the number of follow-up phone calls for both groups, as well as requiring~     participants to complete a family/patient experience survey after speaking to the NP.~   "
88636|NCT02406950|"~     Over the years, numbers of cardioprotective drugs have been evaluated to attenuate lethal~     ischemia-reperfusion (IR) injuries. There is little study whether sitagliptin protects~     against endothelial dysfunction induced by IR injury in humans.~   "
88637|NCT02406937|"~     180 qualified subjects aged from 7 days to 90 days will be enrolled with the 144 completed in~     study (allowing for a 20% drop-out rate). Subjects will be randomly assigned into 3 groups,~     including breast feeding, commercial and new formula group. Study intervention is 12 weeks.~   "
88638|NCT02406924|"~     Twenty four patients with bone resorption on the anterior maxilla will be divided into two~     groups with different kinds of grafting: bone block associated with particulated biomaterial~     and particulated mixture of autogenous bone and biomaterial stabilized by collagen membrane~     and pins. The techniques will be compared according to volume gain, quality of graft~     osseointegration, implant survival and maintenance of the level of soft tissues.~   "
88639|NCT02406911|"~     Antiplatelet treatment in patients with end stage renal disease (ESRD) on hemodialysis (HD)~     is still challenging because of bleeding and thrombotic complications. The investigators~     hypothesized ticagrelor once daily dose would achieve tolerable antiplatelet effects compared~     with ticagrelor twice a day dose in ESRD patients on HD.~   "
88640|NCT02406898|"~     Hysteroscopic surgery is the gold standard for intra uterine pathology especially fibroma.~     Limit of this technic is duration of procedure which is correlated to operative~     complications. So, for patient with large fibrome or several fibromas, this technic is not~     indicated or performs in several times. A new technic of hysteroscopic surgery is available~     which is quicker than conventional technic. This technic is poorly evaluated. Aim of this~     study is to evaluate both technics on procedure duration.~   "
88641|NCT02406885|"~     The Center for Bariatric Surgery is interested in conducting a pharmacokinetic study of~     apixaban (an oral anticoagulant with FDA approval for use of venous thrombo embolism (VTE)~     prophylaxis and treatment) in the obese adult population to determine if bariatric surgery~     influences apixaban exposure. More interesting would be to see how the dose may need to~     change pre- vs. post-bariatric surgery (this will be important for physicians as more and~     more patients undergo this procedure worldwide and many may require anticoagulation in their~     future healthcare).~      Physicians and surgeons are very interested in oral anticoagulants for this special patient~     population. To date, there is no approved dosing for the obese patient (especially when~     considering surgical intervention such as bariatric surgery).~      Primary outcome variable.~      To determine the durability or change in pharmacokinetics and pharmacodynamics of apixaban in~     patients with a body mass index (BMI) of 35 kg/m2 or greater following one of two bariatric~     surgical procedures (pre-operative versus post-operative vertical sleeve gastrectomy or~     Roux-en-Y gastric bypass patients).~      Secondary outcome variables.~        1. To compare/contrast the pharmacokinetics and pharmacodynamics of apixaban in bariatric~          surgical patients who have undergone RYGB vs. VSG.~        2. To determine how the pharmacokinetics of the drug may differ when there is significant~          post-operative surgical weight loss (>40% estimated excess body weight) 12 to 18 months~          following surgery versus those patients who have suboptimal weight loss following~          bariatric surgery (< 40% of estimated excess body weight).~   "
88642|NCT02406872|"~     The purpose of this study is to find out the optimal dose for Remimazolam Tosilate as an~     intravenous general anaesthetic drug in operations and to determine its efficacy and safety~     profile comparing to propofol.~   "
88643|NCT02406859|"~     An injury to the spinal cord results in a number of secondary medical problems, including the~     inability to voluntarily control the bowels. Depending on the severity and location of the~     injury, remaining bowel function differs, and can include any combination of the following:~     constipation (prolonged stool retention), difficulty with evacuation (difficultly moving~     bowels), fecal incontinence (problems retaining stool until it is appropriate to move the~     bowels). Most of the current medications and treatment options address problems of~     constipation and difficulty with evacuation, but there are few options for individuals who~     suffer from incontinency. In this study, the investigators propose to study, in detail,~     anorectal muscle function in individuals with spinal injury - the investigators will do so~     using new technology called high resolution manometry - which will present the investigator~     with a 3 dimensional representation of the pressure profile of the anorectal muscles as the~     subject attempts different maneuvers. A subgroup with representatives of all levels and~     completeness of injury and anorectal muscle function will be enrolled to participate in six~     weeks of biofeedback training to see if their bowel function can be improved. During these~     six weeks, the subjects will be asked to visit the laboratory twice a week in order to be~     trained by the research team on how to improve their anorectal strength and function in~     response to visual cues. After the six weeks, another manometry study will be performed.~     Subjects will then be sent home and asked to perform a series of home exercises for another 6~     weeks, after which they will asked to return for a third and final manometry study.~   "
88644|NCT02406846|"~     Circulating tumor cells (CTCs) have the potential to provide a surrogate for'real-time~     biopsy' of tumor biological activity. Enumeration and molecular characterization of CTCs in~     pancreatic cancer could play an important role in diagnosis, predicting the risk for tumor~     recurrence, and providing novel target therapy biomarkers.In view of these facts, We wanted~     to demonstrate the value of multiparameter flow cytometry in detecting human tumor cells of~     pancreatic cancer in normal peripheral blood after cryosurgery with or without dendritic~     cell(DC)-cytokine-induced killers(CIK) treatment, and we also compared the specificity with~     reverse transcriptase polymerase chain reaction (RT-PCR) method.~   "
88645|NCT02406833|"~     This study evaluates the addition of ISTH0036, an antisense oligonucleotide against TGF-β2,~     to glaucoma filtration surgery (trabeculectomy). The treatment aims at improving the surgery~     outcome by prevention of excessive scarring and trabecular meshwork transformation.~   "
88646|NCT02406820|"~     HF001 is a prospective observational study utilizing non-invasive medical devices that may be~     able to discriminate changes in heart failure while acutely decompensated patients undergo~     routine interventional therapies in a hospital setting. Subjects will be monitored using~     CVInsight™ [CVI] via a finger and/or forehead sensor, while performing an isometric handgrip~     stress test (IHGST). Changes in the CVI signal will be analyzed and correlated to standard~     assessments of heart failure including pulmonary artery catheter (PAC) pressures, blood~     pressure (BP), patient symptoms, and physical exam findings. The results of this study will~     be used to develop a powered study to determine if a new configuration of non-invasive~     monitoring devices can be used to monitor heart failure status more sensitively than current~     non-invasive techniques.~   "
88647|NCT02406807|"~     High-Velocity Low-Amplitude (HVLA) manipulation is a known technique of the Osteopathic~     Manipulative Treatment (OMT) for somatic dysfunction (SD), and heart rate variability and~     H-reflex response are possible variables to assess its neurophysiological effects. Somatic~     dysfunction is an impairment or altered function of related components of the somatic system.~      Studies show a transient attenuation of α-motor neuron excitability after HVLA manipulation~     in asymptomatic participants. According to studies, HVLA spinal manipulation increases joint~     mobility by blocking afferent impulses in the muscle spindle and the small-diameter free~     nerve, decreasing the γ-motor neuron activity.~   "
88658|NCT02406664|"~     The purpose of this study is to determine the change in kidney function and blood pressure~     after gastric bypass versus conventional medical therapy in morbid obesity. The study mainly~     focus on glomerular filtration rate(GFR) with known relation to the renal function and 24~     hours ambulatory blood pressure monitoring after intervention of gastric bypass or medical~     treatment.~   "
88659|NCT02406651|"~     A Phase IIa single arm open-label study to investigate the safety, tolerability, and PK of~     F-652 in combination with systemic corticosteroids in subjects who have undergone~     Hematopoietic Stem Cell Transplantation (HSCT) and have newly diagnosed grade II-IV lower GI~     acute Graft Verses Host Disease (aGVHD). Treatment with F-652 will be once a week for 4~     weeks, with post treatment follow up visits on days 28, 56, 180 and 365.~   "
88648|NCT02406794|"~     Background: It has been demonstrated that aromatase inhibitors (AIs) are more effective than~     tamoxifen in reducing breast cancer recurrence. However, despite the excellent results, the~     side effects associated with them cause between 24.5 and 31.3% therapy abandon. This study~     aimed to verify the effectiveness of Neuromuscular Taping (NMT) in the treatment of myalgia~     and arthralgia induced by AIs in women who have had breast cancer. Our goal is to improve~     their pain, decreasing by 20% the values of their Visual Analogue Scale (VAS) at various~     points in order to improve symptoms and increase adherence.~      Methods/Design: The study includes 156 breast cancer survivors treated with endocrine therapy~     (aromatase inhibitors or tamoxifen and aromatase inhibitors) from Virgen de la Victoria~     Hospital (Málaga, Spain) and musculoskeletal disorders resulting from such treatment.~     Clinical and patient data were obtained from medical histories, genetic and proteomic~     analysis, grip strength and algometry measured, questionnaires and the outcome of interest,~     their VAS. NMT is applied in four possible locations, according to the symptoms of each~     participant: carpal tunnel, cervical, lumbar or lumbar and cervical. There are several more~     interventions before repeating the readings from the last five weeks of the start of the~     study.~   "
88649|NCT02406781|"~     This is a multicenter study assessing efficacy of the MK 3475 (Pembrolizumab) in combination~     with metronomic cyclophosphamide in patients with advanced sarcomas.~   "
88650|NCT02406768|"~     To determine the neurodevelopment (ND) in normal children in Thailand and Cambodia and to use~     this group to compare the neurodevelopmental changes over time to the HIV-infected children~     with and without HAART (main study).~   "
88651|NCT02406755|"~     Randomized clinical trial about self-care mediated by the senses in female health~     professionals and their influence on stress, self-esteem, mood states, life satisfaction and~     levels of salivary cortisol.~   "
88652|NCT02406742|"~     Safety, pharmacokinetics, and preliminary efficacy of CC-122 alone and in combination with~     ibrutinib and obinuzutumab.~      CC-122 has multiple activities, including immune modulation of several immune cell subsets~     and antiproliferative activity in CLL. CC-122 has also been shown to have a tolerable safety~     profile with some preliminary signs of efficacy with early human experience.~   "
88653|NCT02406729|"~     This is a randomized, multicenter, double-blind, placebo-controlled Phase III study that will~     evaluate efficacy and safety of a live attenuated, tetravalent, lyophilized dengue vaccine~     produced by Butantan Institute.~      The study will be carried out in multiple sites in Brazil. The study will be community-based~     in select urban areas where there's dengue transmission.~      Study's intervention will be a single dose of the tetravalent dengue vaccine or placebo in a~     ratio 2:1. For efficacy analysis will be considered all dengue cases occurring after 28 days~     post-vaccination in the entire population of 16944 participants.~      For safety analysis participants will be divided in three age groups: 18 to 59 ys, 7-17 ys~     and 2 to 6 ys. In each of these age groups there will be a minimum of 4992 participants. The~     age groups of 18 to 59 ys and 7 to 17 ys will start first. Once safety data for the first 21~     days after vaccination is analysed for 450 participants in 7-to17-ys age group, the following~     group, of 2 to 6 ys, will start.~      The study's hypothesis is that the vaccine under investigation and produced by Butantan~     Institute is safe and provides protection against dengue symptomatic disease of 80% or more~     with a lower bound of the 95% confidence interval of 25%. This way, the expected number of~     dengue cases virologically confirmed is 24 or more which will provide a response in terms of~     vaccine efficacy.~      All participants will be followed up for five years to verify dengue incidence, regardless~     severity.~   "
88654|NCT02406716|"~     This study hypothesis is that Semaphorins 3A and 4D levels are overexpressed in patients with~     heart failure. Study protocol:~      Hospitallized patients with new onset or previously diagnosed heart failure will be recruited~     to the study. Control group will include healthy people with no medical records or chronic~     treatment at the same age range. After signing an informed constent form, full medical~     history and blood samples will be collected. A second blood sample will be collected 8 weeks~     later, assuming the patient was discharged and not hospitalized since than. The blood samples~     will be analyzed by Bnai Zion Medical Center Immunology labs for the above semaphorins levels~     in the heart failure group and control group. Statistical analysis will then commence for~     possible correlatoion with different clinical parameters.~   "
88655|NCT02406703|"~     Background and Objectives Short acting regional anesthetics have already been successfully~     employed for peripheral nerve blocks in an ambulatory surgery setting. However, the impact on~     direct and indirect perioperative costs comparing two different short-acting local~     anesthetics has not been performed, yet.~      Methods In an observational study including 50 patients per group, patient undergoing~     popliteal block with chloroprocaine 3% or mepivacaine 1.5% for ambulatory minor foot surgery~     were compared. The primary outcome was the saving of both direct and indirect perioperative~     costs. Secondary outcomes were block success, onset time and block duration, patient~     satisfaction and unplanned outpatient visits or readmissions after discharge.~   "
88656|NCT02406690|"~     The purpose of this study is to determine the differences that exist in RNA molecules, the~     biochemical process of methylation, and estrogen receptor binding in patients that have~     failed to produce adequate endometrium in synthetic embryo transfer cycles when compared to~     patients whose endometrium thickness is within normal limits.~   "
88657|NCT02406677|"~     Current patterns of P2Y12 receptor inhibitor use provide an excellent opportunity to test the~     impact of copayment reduction on clinician choice of medication, patient adherence, and~     clinical outcomes. The ARTEMIS trial is a practical multicenter, cluster- randomized clinical~     trial that will assess the impact of copayment reduction by equalizing the copayment of~     clopidogrel and ticagrelor. ARTEMIS will assess prescribing patterns, patient medication~     adherence, and clinical outcomes up to one year. We hypothesize that reducing out--of--pocket~     cost for P2Y12 receptor inhibitor will lead to improved adherence. Additionally, copayment~     reduction of both generic and brand antiplatelet agents may lead to a reduction in MACE risk.~     This is in part due to greater adherence to an evidence--based secondary prevention~     medication. Additionally the reduction in MACE may reflect greater selection of a more potent~     antiplatelet agent that has been shown to reduce MACE in randomized clinical trials, as~     provider choice of antiplatelet therapy will be primarily driven by risk- benefit assessment~     rather than the cost burden to the patient.~   "
88660|NCT02406638|"~     Compare through 3D USG the tape spatial orientation, in three different techniques of~     insertion of mid-urethral synthetic sling, correlating USG findings to postoperative results~     in an average of three years follow-up.~      Methods: This is a transversal study of a cohort women surgically treated for stress urinary~     incontinence by retropubic sling (TVT-R), transobturator sling (TVT-O) or single-incision~     sling (TVT-S). The clinical and USG evaluation were performed at the same medical visit, from~     April 2013 to June 2014, .~   "
88661|NCT02406625|"~     Suicidal behaviors among adolescents represents a public health problem due to its high~     prevalence and its low predictability. It is also known that brain development continues~     during adolescence, therefore, a therapeutic intervention during this period might propitiate~     neural changes that might favor the emotional regulation involved in suicidal behaviors.~     Dialectical Behavioral Therapy has proved to be effective regarding this problem.~      For this reason, the investigators aimed to study the clinical, neuropsychological and neural~     effects of Dialectical Behavioral Therapy in adolescents with suicidal behaviors.~   "
88662|NCT02406612|"~     The study is designed to prospectively collect data on and confirm the safety and~     effectiveness of the X-Seal 6F Vascular Closure System in reducing time to hemostasis and~     time to ambulation for patients who have undergone diagnostic or interventional~     catheterization procedures using up to 6F sheaths when compared with standard compression~     techniques using data from literature surveys.~   "
88663|NCT02406599|"~     The study objective is to determine the MarginProbe® System's diagnostic accuracy at the~     margin level and impact on Positive Margin* Presence originating from the Main ex-vivo~     lumpectomy specimen after the initial lumpectomy surgery.~      *A positive margin is defined in this study as a margin microscopically measured and reported~     in the histology report to have cancer within 1 mm or less of the inked surface~   "
88664|NCT02406586|"~     The purpose of this study is to see if salsalate, an Nuclear factor-kappaB (NF-κB) mediated~     inflammation inhibitor, or carvedilol, an α- and β-blocker, will protect against free fatty~     acid induced hypertension, insulin resistance, endothelial dysfunction, inflammation and~     oxidative stress, and autonomic dysfunction in obese normotensive subjects.~   "
88665|NCT02406573|"~     This pilot study will evaluate the use of nominal stimuli to assess dentinal hypersensitivity~     response relative to a clinically-controlled stimulus.~   "
88666|NCT02406560|"~     Each subject will be given tafamidis after either a high fat meal or while fasted. After~     swallowing tafamidis, tafamidis blood concentrations will be measured periodically for one~     week. After about 14 days, subjects will take either a different dose of tafamidis or the~     same dose under the opposite meal condition. Tafamidis concentrations from the three~     different conditions will be compared to determine if they are approximately the same.~   "
88667|NCT02406547|"~     This study is designed to evaluate the utility of Narrow Band Imaging (NBI) compared with~     High Definition White Light colonoscopy (WLE) in subjects with serrated lesions who do not~     fulfill the diagnostic criteria of Serrated Polyposis Syndrome (SPS).~   "
88668|NCT02406534|"~     This is an observational study to evaluate the relationship between pulmonary function and~     the patient reported health-related quality of life (HRQoL) and chronic obstructive pulmonary~     disease (COPD) related admissions. Patients with COPD will be approached to participate in~     the study. Pulmonary function will be measured on consented, eligible patients. The pulmonary~     function measurement collected will be used for cohort assignment. The prospective follow up~     period will monitor the cohorts for evidence of readmission and to assess HRQoL.~   "
88669|NCT02406521|"~     This research study is comparing different drug combinations as a possible treatment for~     metastatic renal cell carcinoma (mRCC) and bone metastases.~      The names of the study interventions involved in this study are:~        -  Combination of Radium-223 and Sorafenib~        -  Combination of Radium-223 and Pazopanib~   "
88670|NCT02406508|"~     This is a single arm, open label, multi-center, phase 2 study to evaluate the safety and~     efficacy of sequential treatment with Melphalan/HDS followed by sorafenib in patients with~     unresectable hepatocellular carcinoma (HCC) confined to the liver.~   "
88671|NCT02406495|"~     Open label, 1-week daily disposable, dispensing study~   "
88672|NCT02406482|"~     This study will examine the efficacy of a combined HIV and microfinance intervention to~     reduce biologically confirmed sexually transmitted infections (STIs), and new incidence of~     HIV and HCV, as well as reported sexual and drug risk behaviors among 520 women who have~     injected drugs in the past year and who engage in sex trading in Temirtau and Pavlodar,~     Kazakhstan. The proposed study builds on findings from an R34 by the investigative team~     testing a combination HIV prevention and microfinance intervention. Building on successful~     protocols and significant results, we will randomly assign 520 women who inject drugs and~     engage in sex trading from Temirtau and Pavlodar, Kazakhstan to either (1) a 4 session HIV~     prevention intervention combined with a 6 session financial literacy intervention, enrollment~     in an existing vocational training program and receipt of matched savings (HIVRR+MF); or to~     the 4 session HIV prevention intervention alone. The HIVRR intervention is guided by social~     cognitive theory. The HIVRR+MF intervention integrates asset theory with social cognitive~     theory. The MF includes: 1) financial literacy; 2) vocational training; and 3) micro-savings~     to support transition to a more permanent employment status. We hypothesize that increasing~     financial literacy, enhancing vocational skills required to fill marketable positions in the~     local economy, and beginning a personal savings program, combined with HIV risk reduction,~     will lead to significant reductions in study outcomes compared to an HIVRR intervention~     without a microfinance intervention.~   "
88673|NCT02406469|"~     This is a single-site, double-blinded, randomized, controlled, 2X2 cross-over study aiming to~     compare effects of milk containing only A2 type beta casein versus milk containing both A1~     and A2 beta casein proteins on the gastrointestinal physiology, symptoms and cognitive~     behaviour for the health people who are intolerant to traditional cow's milk.~   "
88674|NCT02406456|"~     Participants will undergo a single session of functional magnetic resonance imaging~     (fMRI)-based neurofeedback (approximately 1 hour). The investigators will assess their~     ability to regulate motivational networks of the brain during the exposure to alcohol cues~     and evaluate immediate effects on craving and cognitive bias for alcohol by administering a~     questionnaire and a Stroop task before and after the session.~   "
88675|NCT02406443|"~     Background: Dedicated renal hemodynamic and renal function studies are lacking for DPP-4~     inhibitors in patients with Type 2 diabetes; accordingly little is known regarding the~     mechanisms mediating the renal effects of DPP-4 inhibitors in humans.~      Objectives: To evaluate the effect of DPP-4 inhibition acutely (single dose) and following~     short-term therapy (28 days) on renal sodium handling and renal hemodynamics and function in~     patients with type 2 diabetes and systolic hypertension.~      Design: double-blind, randomized, placebo-controlled trial, Phase IV.~      Patient population: 32 patients with Type 2 diabetes, HbA1c (6.5%-9%), with systolic blood~     pressure ranging from 120-160 mmHg.~      Intervention: subjects will be randomized (1:1) to either sitagliptin (100 mg daily) or to~     placebo (1 tablet daily) for 28 days.~      Endpoints: Fractional excretion of sodium, renal function, and renal hemodynamics.~   "
88676|NCT02406430|"~     Retrospective interventional case series study reporting preoperative clinical and anatomical~     factors associated with visual recovery 1 year after combined cataract and idiopathic~     epiretinal membrane surgery. Age, duration of symptoms, and preoperative best corrected~     visual acuity appeared to be reliable prognostic factors. Combining these factors with~     analysis of the photoreceptors' inner and outer segments junction in spectral-domain optical~     coherence tomography provides a predictive score to estimate individual chances of good~     visual recovery~   "
88677|NCT02406417|"~     Early detection and management of pituitary dysfunction reduces the morbidity that ensues as~     a consequence of missed or delayed diagnosis of this condition, and which may result in~     life-threatening events and increased mortality.~      The investigators study will explore the use of reflex strategies within the laboratory in~     capturing suspicious pituitary function test results from Primary Care patients and following~     these up with appropriate reflective testing. Subsequently patients identified from these~     results to have a possible underlying piuitary dysfunction will have an alert sent to their~     family physician prompting referral to the Endocrine team for further investigation and~     management.~   "
88678|NCT02406404|"~     This study was designed to examine the effect of incentive spirometry in pulmonary~     rehabilitation of children with cerebral palsy. The incentive spirometer, a device that can~     help improve breathing and strengthen inspiratory muscles. If the patient assigned to~     training group, the subjects started to respiratory muscle strengthening exercise using~     incentive spirometry. The training was performed ten sessions daily, for 4 weeks. Respiratory~     function tests including forced vital capacity, forced expiratory volume in 1 second, Peak~     cough flow, maximal phonation time were compared before interventions and at the end of~     exercise.~   "
88679|NCT02406391|"~     In the United States, the highest incidence of cervical cancer occurs in inner city urban~     centers, rural areas, the deep South, Appalachia and the U.S.-Mexico border. The goal of this~     study is to study predictors of adherence among patients seeking care at an inner city~     medical center in New York City and the U.S. Mexico border for cervical cancer prevention,~     namely, Pap smears and colposcopy exams.~   "
88680|NCT02406365|"~     A handheld digital colposcope which utilizes flurorescent light is being tested for the rapid~     detection and management of cervical lesions. The handheld research device captures cervical~     images which with the fluorescent light show the regions of cervical tissue that~     autofluoresce. The investigators will study the relationship between the level of~     fluorescence and the samples of tissue (biopsies) obtained from the patient as part of her~     routine care. The investigators will also compare the efficacy of the hand held device with~     the data being collected from the other research devices being tested by the team, i.e. the~     multispectral digital colposcopes.~   "
88681|NCT02406352|"~     Although cervical cancer is a preventable cancer, every year more than one-quarter of a~     million women die worldwide from this disease. Internationally and nationally, cervical~     cancer is a disease that affects predominantly women who are poor and who live in resource~     poor settings. With the device the investigators are developing, known as the Multispectral~     Digital Colposcope with probe, our goal is to make detection of precancerous cervical lesions~     easier for the patient and for her provider. For the patient, our goal is to reduce the~     number of clinical visits needed to obtain a diagnosis and treatment and consequently to~     reduce the resulting fear and anxiety which usually accompanies an abnormal Pap smear. For~     the provider and the health care system, our goal is to obtain a more accurate diagnosis than~     the currently available diagnostic methods.~   "
88682|NCT02406339|"~     This study evaluates the effect of training with neuromuscular electrical stimulation (NMES)~     associated with vascular occlusion of the lower limbs, for increased strength and hypertrophy~     of the quadriceps muscle of professional basketball athletes.~   "
88683|NCT02406326|"~     This is a multi centre, prospective trial. 250 patients will be enrolled in the study.(10~     patients per centre involving approximately 25 centres). Patients will be followed up~     clinically for twelve months post-procedure at 1 month, 6 months & 12 months. All patients~     will have a repeat angiography at 8 months. Clinical follow-up will be maintained for years 3~     & 5 post-implant.~   "
88684|NCT02406313|"~     The study evaluates the efficiency, in terms of quality of life improvement, of a patient's~     therapeutic education program (ETP), based on long term commitment in adapted physical~     activities carried out during a standardized thermal cure (CTS) for fibromyalgia among~     patients continuing regular drug treatment or not~   "
88685|NCT02406300|"~     This study evaluates the effect of anesthesia on mortality after surgical repair of proximal~     femur fracture.~      Patients will receive either a subarachnoid block or a combination of peripheral nerve blocks~     and light general anesthesia (PNB/GA).~      The investigators hypothesis is that a combination of peripheral nerve blocks with an opioid~     free light anesthesia may have more favourable outcomes.~      Both groups will be followed up for assessment of post-operative morbidity and mortality.~   "
88686|NCT02406287|"~     To evaluate the effect of netarsudil (AR-13324) ophthalmic solution on aqueous humor dynamics~     relative to its placebo.~   "
88687|NCT02406274|"~     Contrast Enhanced Spectral Mammography (CESM) is an advanced form of mammography which is~     performed after injection of contrast or dye into a vein in the arm. This dye is the same dye~     that is used for CT scans. This type of mammogram includes a regular mammogram as well as~     additional pictures with the dye.~      This particular study is being done to determine if by adding the dye in the veins the~     investigators are better able to identify the cause of the lump than if they just did the~     regular mammogram alone.~   "
88688|NCT02406261|"~     The purpose of this study is to study the effect of lanabecestat on how the body absorbs and~     processes 3 other medications, midazolam, simvastatin and donepezil and how these 3~     medications affect lanabecestat when they are taken together. This study is in 2 cohorts,~     Cohort A is approximately 44 days long and Cohort B about 70 days only. The screening visit~     is required within 30 days prior to the start on the study~   "
88689|NCT02406248|"~     A multicenter, single arm, open label, Phase IV study to evaluate safety and to describe the~     cumulative incidence of major cardiovascular events of Ticagrelor in Taiwanese patients with~     non ST-segment (a segment in the eletrocardiogram which presents the period when ventricles~     are depolarized) elevation myocardial infarction~   "
88690|NCT02406235|"~     The overall objective of this study is to assess turnaround time, pre-BRCA test onco-genetic~     counselling quality and satisfaction with a new onco-genetic BRCA testing model.~   "
88691|NCT02406222|"~     This study is determining whether the addition of cyclophosphamide to pomalidomide and~     dexamethasone improves progression free survival in patients with relapsed refractory myeloma~     (RRMM) compare to pomalidomide and dexamethasone alone. Patients will be randomised on a 1:1~     basis to receive CPD or Pd. Treatment will be continued until disease progression or~     unacceptable toxicity.~   "
88692|NCT02406209|"~     This is a randomized, multi-center, investigator masked, comparator controlled study. The~     purpose of this study is to determine the efficacy and safety of NS2 in patients with~     non-infectious acute anterior uveitis. Subjects will be randomized 1:1:1 to receive multiple~     doses of NS2 0.5%, NS2 0.5% and Pred Forte® 1%, or Pred Forte® 1%.~      Free aldehydes are thought to be related to inflammatory diseases such as uveitis. NS2, a~     small molecule aldehyde trap, may decrease inflammation by lowering aldehyde levels.~   "
88693|NCT02406183|"~     The prognosis of advanced metastatic melanoma remains poor although a breakthrough has been~     achieved with the novel anti-CTLA-4 treatment (ipilimumab) for a subset of patients.~     Unfortunately, due to immune resistance, the majority of patients do not obtain long-lasting~     clinical benefit. Radiotherapy is able to interfere with immune resistance by inducing~     immunogenic cell death. Preclinical evidence indicates that combining radiotherapy with~     anti-CTLA-4 treatment increases response rates compared to single agent treatment. These data~     are supported by several spectacular clinical cases and one retrospective study. The~     investigators hypothesize that combining ipilimumab with radiotherapy will result in a higher~     response rate compared to ipilimumab or radiotherapy in monotherapy. Given the complexity of~     the interaction in anti-tumor immunity, the first goal of this project is to assess the~     safety of the combined treatment.~   "
88694|NCT02406170|"~     Patients with advanced oesophagogastric cancer (OCG) have a very poor prognosis. After~     progression on first line therapy, second line chemotherapy with paclitaxel and a VEGF-R2~     targeting antibody has a proven benefit on survival. However, no data are available on the~     combination of paclitaxel with kinase inhibitors in advanced OGC. Here the investigators~     propose a Phase 1b study to assess the tolerability of regorafenib (an oral multi kinase~     inhibitor) in combination with paclitaxel and to assess the uptake of paclitaxel in OCG~     metastasis.~   "
88695|NCT02406157|"~     This randomized, parallel controlled, clinical-trial aims to evaluate the therapeutic~     efficacy and safety of 577nm micropulse laser photocoagulation for diabetic macular edema~     compared with 532 subthreshold laser photocoagulation.~   "
88696|NCT02406144|"~     This protocol is a randomized, open-label, national, multicenter trial studying maintenance~     treatment with lenalidomide and dexamethasone versus lenalidomide, dexamethasone and MLN9708~     after autologous hematopoietic stem cell transplantation in patients with newly-diagnosed~     symptomatic multiple myeloma.~      A total of 316 patients, from the study GEM2012MENOS65, will be enrolled in the study.~      The pre-treatment period includes the screening visit in which participants provide informed~     consent in writing in order to take part in the study. The patient is then assessed to~     determine his/her eligibility. The selection process will begin 21 days before the first dose~     of medication is administered (days -21 to 0). All procedures during the pre-treatment period~     will be carried out after completion of the two cycles of post-transplant consolidation with~     VRD which coincide with the end-of-study visit of clinical trial GEM2012MENOS65.~      During the treatment period, eligible patients will be included in the study and receive~     maintenance treatment with lenalidomide/dexamethasone versus~     lenalidomide/dexamethasone/MLN9708. Each cycle will last 28 days. Treatment arm A will~     consist of oral administration of 15 mg/day of oral lenalidomide on days 1-21, and 20 mg/day~     of dexamethasone administered orally on days 1-4 and 9-12 for a period of two years. Arm B of~     the maintenance treatment will be the same as arm A, with the addition of MLN9708 during the~     two year maintenance period, at a dose of 4 mg/day on days 1, 8 and 15 of the cycle.~      At two years, patients with negative MRD will finish maintenance treatment. Patients with~     positive MRD will continue treatment with lenalidomide/dexamethasone until they have~     completed five years of maintenance treatment. In this case, 20 mg/day of dexamethasone will~     only be administered on days 1-4 of the cycle. The dose of lenalidomide will not be adjusted.~     (unless necessary to treat adverse events)~      Once this phase of active treatment is complete, patients will begin the long-term follow-up~     phase, during which they will be visited every three months to evaluate progression and~     survival.~   "
88697|NCT02406131|"~     The investigators will established relation between restenosis and inflammatory response to~     shearing stress caused by angioplasty suggest that any mechanism that affect inflammatory~     response can consequently affect the restenosis rate. There is accumulated evidence that~     remote ischemic precondition has modifying suppressive effect on inflammatory response and~     the investigators hypothesized that RIPC may lead to reduction in post angioplasty restenosis~     rate.~   "
88698|NCT02406118|"~     The purpose of this study is evaluation of the safety and the efficacy of transanal total~     mesorectal excision.~   "
88699|NCT02406105|"~     Clinical objective of the study is estimation of effectiveness and safety of Cyber Knife~     based functional radiosurgery for Parkinson disease patients suffering from tremor.~   "
88700|NCT02406092|"~     This open-label, single-arm study will evaluate the safety of rituximab subcutaneously (SC)~     administered during first line treatment for follicular non-Hodgkin's lymphoma (NHL)~     (Induction and/or Maintenance treatment plus 24 months of follow up), or diffuse large B-cell~     lymphoma (DLBCL) (treatment plus 24 months of follow-up).~   "
88701|NCT02406079|"~     Procalcitonin (PCT) is a reliable biomarker of infection and sepsis. The investigators aimed~     to determine whether tracheotomy influences PCT concentrations in patients without sepsis,~     and to assess whether operative duration and procedure affect the peak PCT level.~   "
88716|NCT02405884|"~     Objective: To evaluate the variation in intraocular pressure in patients with chronic kidney~     disease, according to the time interval between hemodialysis sessions and to the influence of~     weight and blood pressure on intraocular pressure.~      Methods: This was a cross-sectional study in which 78 eyes of 39 patients on hemodialysis, at~     the Santa Casa de Misericordia de Goiânia hospital, were analyzed in June 2014. Patients were~     divided into groups according to the days on which they underwent hemodialysis. The mean,~     standard deviation, and median of the intraocular pressure, blood pressure, and weight were~     calculated. P-values <0.05 were considered statistically significant.~   "
88702|NCT02406066|"~     This is a study of EMB-001 (a combination of two FDA-approved drugs, metyrapone and oxazepam)~     in otherwise healthy adults who are regular cigarette smokers. There will be 3 groups of 8~     subjects; in each group, 6 subjects will get the drug combination and 2 will get placebo.~     Neither the subjects nor the study personnel will know who got drug and who got placebo~     (double-blind). In the first group the drug doses will be low, and they will be increased in~     the second and third groups. Subjects will receive a single dose on Day 1, followed 24 hours~     later by the start of doses twice daily for 7 days, and then a final morning dose on the last~     day. The levels of the drugs in the blood will be assessed by repeated blood draws after the~     first day and after the end of dosing. Safety will be assessed after the single dose and~     repeated dosing. Effects of study drug on smoking and craving cigarettes will be assessed at~     the end of repeated dosing. The hypothesis is that this drug combination will be safe, with~     relatively few side effects.~   "
88703|NCT02406053|"~     The environmental pollutants and endogenous reactive oxygen metabolites from inflammatory~     cells exert substantial pathological effects on the lung cells [1]. Oxidative stress (OS) is~     a major factor that plays a significant role in lung cancer (LC) [2], chronic obstructive~     pulmonary disease (COPD) [3] and obstructive sleep apnea syndrome (OSAS) [4, 5]. The current~     evidence suggests that OS takes part in the mechanisms involved in initiation, promotion and~     progression of respiratory diseases. The major exposures that cause OS can be summarized as~     smoking, and ambient air pollution that contains particulate matter smaller than aerodynamic~     diameter of 2.5 µm [6-8]. Epidemiological and clinical studies showed that the overall~     outcome of pulmonary OS is increased mortality due to increased incidence of respiratory~     diseases [9].~   "
88704|NCT02406040|"~     Weight loss through energy restriction results in the loss of both fat and muscle mass.~     Muscle mass is important for mobility, strength, glucose control and energy expenditure, and~     therefore the retention of muscle mass during energy restriction is an important goal. The~     retention of muscle mass depends on the balance between muscle protein synthesis (MPS) and~     muscle protein breakdown (MPB). It is well known that MPS is reduced during weight loss,~     however the effect of weight loss on MPB is currently a topic of debate. The purpose of this~     study is to assess the effect of short-term (10 day) weight loss (40% energy deficit) on both~     MPS and MPB in order to gain insight into the mechanisms causing muscle loss during energy~     restriction. In addition, the effect of resistance exercise and protein (both known to~     preserve muscle mass) on MPS and MPB will be examined~   "
88705|NCT02406027|"~     The purpose of this study is to evaluate the long-term safety and tolerability of~     JNJ-54861911 in participants in the early Alzheimer's disease (AD [progressive brain disease~     that slowly destroys memory and thinking skills, and eventually even the ability to carry out~     the simplest tasks]) spectrum that have completed a Phase 1b or Phase 2 clinical trial with~     JNJ-54861911, who are willing to continue their assigned treatment.~   "
88706|NCT02406014|"~     This is a phase 4, multi-centre, randomized, two group, open label, active controlled,~     parallel group, 17 week trial.~   "
88707|NCT02406001|"~     The purpose of this randomized trial was to compare reconstructive surgery of advanced~     peri-implant intra-osseous defects with porous titanium granules (PTG/Test) to open flap~     debridement (OFD/Control) in a non-submerged technique over 6 months.~   "
88708|NCT02405988|"~     Overdose with potential deadly outcome is a serious problem among opioid abusers, not least~     in Norway. To save lives, immediate treatment with a μ-opioid antidote such as naloxone is~     required. The purpose of this study is to explore the pharmacokinetics and pharmacodynamics~     of naloxone in healthy volunteers under opioid influence.~   "
88709|NCT02405975|"~     This study will assess, by means of a randomized controlled trial, the impact of an online~     educational tool, on doctors' knowledge and confidence with regards to prescribing for older~     patients.~   "
88710|NCT02405962|"~     The purpose of this study is to examine whether a parental training program using group-based~     Acceptance and Commitment Therapy for childhood asthma care, is effective in reducing the~     number of children's unplanned health care services utilization and asthmatic symptoms.~   "
88711|NCT02405949|"~     Obesity is directly related to an increased risk of diabetes mellitus, hypertension,~     dyslipidemia, cardiovascular disease, and overall mortality. Weight loss is effective in~     decreasing these risks and to reduce disease severity. Bariatric surgery is an effective~     therapy for sustained weight loss and type 2 diabetes (T2D) remission in most of the morbidly~     obese patients. But there is also a significant number of individuals with an inappropriate~     response to bariatric surgery. Two recent retrospective studies assessed the role of genetic~     load as a predictor of this response, but the results are still unelucidated. The aim of this~     study is to assess whether a selection of genetic variants may allow us to identify~     individuals who will have a satisfactory response after bariatric surgery in terms of weight~     loss and T2D remission.~   "
88712|NCT02405936|"~     The aim of this prospective study is to collect data on patients undergoing gynecologic~     surgery at Kangbuk Samsung Hospital.~   "
88713|NCT02405923|"~     This is a multicenter, controlled, randomized, prospective, non-inferiority, double blind~     intervention trial to evaluate the children growth (at 6, 9 and 12 months) using a rice~     hydrolysed protein formula compared to an extensively cow's milk protein hydrolysed formula~     for the management of Cow's Milk Protein Allergy (CMPA).~   "
88714|NCT02405910|"~     Phase II study to determine progression free survival (PFS) of nab-paclitaxel administered in~     combination with gemcitabine, at two different dose combinations as first line therapy in~     patients with unresectable stage IIIB/stage IV non-squamous non-small cell lung cancer~     (NSCLC).~   "
88715|NCT02405897|"~     Sarcoidosis is a systemic disease that results from granulomatous inflammation that involves~     multiple body organs. The diagnosis requires the presence of compatible clinicoradiological~     features along with histologic evidence that demonstrates non-caseating.1 Mediastinal lymph~     nodes and the lung parenchyma are the most commonly involved structures in sarcoidosis that~     can be sampled by, performing various bronchoscopic techniques. In a recent study the use of~     alligator forceps had a better yield in comparison to cup forceps. The investigators~     hypothesize that use of fenestrated alligator forceps in comparison to fenestrated cup~     forceps will yield larger samples, thereby improving the diagnostic yield and reducing the~     number of biopsy samples irrespective of the stage of sarcoidosis.~   "
88718|NCT02405845|"~     Hardened plaque located in the carotid arteries can cause stroke or transient ischemic attack~     (TIA). This type of plaque is linked to unstable free-floating thrombi (FFT). FFT are blood~     clots that form in a blood vessel, and are at the highest risk for travelling within the~     bloodstream and causing strokes. Physicians are able to see this type of plaque with computed~     tomographic angiography (CTA) but FFT look very similar to stable types of plaque that do not~     require urgent treatment.~      Distinguishing between these plaques is important because it affects the choice and urgency~     of treatment that patients receive.~      The researchers have found a promising visual marker on CTA scans. The goal of this study is~     to determine if this visual marker seen on CTA scans will help to distinguish FFT plaque from~     stable plaque.~   "
88719|NCT02405832|"~     The objective of this study is to assess the effect of preoperative administration of oral~     zinc lozenges on the incidence of postoperative sore throat syndrome.~      When patients undergo surgery with general anesthesia, they require ventilation of their~     lungs with the help of a flexible tube (called an endotracheal tube) that is placed through~     the mouth, passing the vocal cords, and into the windpipe (trachea). This tube helps~     oxygenate the patient, delivers anesthetic gas to the lungs, and keeps the airways open to~     prevent asphyxiation. The procedure is invasive and uncomfortable, and one of the most common~     consequences is a sore and inflamed throat after the tube is taken out. This is termed~     postoperative sore throat (POST). Though the intensity and severity of sore throat varies~     from person to person, the reported incidence is as high as 90% of patients undergoing~     general anesthesia.~      Zinc therapy has been shown in multiple studies to reduce the severity and duration of cold~     symptoms, and also to up-regulate the immune system. Recent studies have shown that zinc can~     act as an anti-inflammatory agent and can maintain the integrity of skin and mucosal~     membranes (which cover the inside of the mouth and throat). The aim of this study is to~     evaluate the effects of giving zinc lozenges before tube placement on postoperative sore~     throat.~      After written informed consent is received in pre-op, a sealed and coded envelope with either~     the zinc lozenge or the placebo lozenge will be given to the patient to be administered~     orally, with the instruction to dissolve the lozenge by sucking on it 30 minutes prior to~     surgery. Upon completion of surgery and emergence from general anesthesia, the patient will~     be extubated and transferred to the post-anesthesia care unit (PACU). Once in the PACU, the~     patient will be assessed regarding the incidence and severity of POST by the study~     investigator using a standardized scale. The severity of POST will be graded on a 4-point~     scale ranging from 0 to 3; 0 being no sore throat, 1 being mild discomfort (complains only~     upon questioning), 2 being moderate sore throat (complains on his/her own), and 3 being~     severe sore throat (change in voice, hoarseness, and throat pain). This evaluation will be~     performed at 30 minutes, 2 hours, 4 hours, and 24 hours post-surgery, with the assessment at~     4 hours being the primary outcome of the study.~   "
88720|NCT02405819|"~     Objective: to describe and compare the implementation of two cancer survivorship care tools:~     (1) 'My Care Plan': a patient-initiated tool and (2) 'Survivorship Care Plan Builder': a~     provider-initiated tool. The results of this study will be used to (1) provide an initial~     assessment of the two survivorship care planning tools and (2) inform the design and conduct~     of a larger study.~   "
88721|NCT02405806|"~     The overall aim for this study is to evaluate the clinical effects of a modified diet on~     metabolic risk factors such as diabetes mellitus and obesity, and the mechanisms this~     nutrition composition exerts on gastrointestinal physiology, inflammatory responses, and~     quality of life, where the subjects are their own controls.~      Within this study, the investigators will be able to relate the nutritional composition to~     metabolic disorders, the gut microbiota, secreted intestinal neuropeptides, and bio- and~     inflammatory markers in serum, plasma and urine.~   "
88722|NCT02405793|"~     The purpose of this study is to evaluate the safety and efficacy of a low dose and a high~     dose of Meloxicam SoluMatrix® Capsules versus Meloxicam Tablets for the treatment of pain due~     to osteoarthritis of the knee or hip.~   "
88723|NCT02405780|"~     The purpose of the study is to compare the safety, effectiveness and immunogenicity of FKB327~     in comparison to Humira® in rheumatoid arthritis patients who have completed study FKB327-002~     and have inadequate disease control on methotrexate.~   "
88724|NCT02405767|"~     The BIPPED study seeks to determine whether wound healing, in particular diabetic foot~     ulcers, can be monitored using electrical bioimpedance analysis (BIA). BIA measures the~     resistance of biological tissue to the passage of a very small electric current applied with~     electrodes. Different types of tissue, due to cell structure, hydration and vascularization,~     have specific electrical characteristics. The BIPPED study aims to provide experimental data~     for the development of a BIA sensor for monitoring of wound healing in chronic wounds.~   "
88725|NCT02405754|"~     This is a retrospective study, designed to be conducted at a single-center in the US. The~     study will conduct a one-time data abstraction from approximately 500 patient medical charts~     who received Age/Sex/Gene Expression score (ASGES) also knows as Corus CAD testing, by order~     of the Principal Investigator. Limited demographic data and patient data pertaining to~     cardiology referral or advanced diagnostic testing will be collected. All data will be~     collected anonymously.~   "
88726|NCT02405741|"~     Hyperbaric chamber treatment assists in increasing the amount of oxygen in the plasma and in~     the tissues and has been proven to be beneficial in treating different ischemic wounds, and~     acute retinal artery occlusion (ARAO) but its effect hasn't been tested in CRVO patients yet.~   "
88727|NCT02405728|"~     The use of peripherally inserted central catheters (PICCs) represents a major advance for~     hematological patients, enabling the effective delivery of chemotherapy and/or blood products~     particularly for prolonged infusions or in situation of difficult venous access. In modern~     medical practice their use has increased rapidly for several reasons, including ease of~     insertion, many uses (e.g., drug administration and venous access), perceived safety, and~     cost-effectiveness compared with centrally inserted central catheters (CICCs).~   "
88728|NCT02405715|"~     This study evaluates the addition of intranasal oxytocin to the treatment of Major Depression~     using interpersonal psychotherapy. Half of the participants will receive a placebo adjunct to~     interpersonal psychotherapy, and the other half will receive oxytocin.~   "
88729|NCT02405702|"~     The infection of a total knee replacement often imposes changing implants. The change in two~     step is currently considered the gold standard. The change in one step is a much debated~     attitude: strictly contra-indicated for some professionals, but others agree to reserve these~     for favorable suspected cases selected. Several criteria have been proposed in the~     literature: age, condition, duration of infection, known bacterium responsible, not virulent~     and sensitive to antibiotics, no fistula, no significant bone destruction. But these criteria~     are poorly validated, standing over an experience of surgical teams rather than high-level~     scientific studies. Some authors have proposed to achieve change in one step systematically.~     The results of these cohorts on healing the infection does not seem very different from the~     changes in two steps. But it is most often single-center series, uncontrolled, with small~     numbers.~   "
88730|NCT02405689|"~     The aim of this study was to investigate the myocardial protective effects of remifentanil~     and dexmedetomidine in cardiac surgery.~   "
88733|NCT02405650|"~     Obesity and chronic kidney disease (CKD) are major public health problems. In contrary to~     observations in general population, higher body mass index in those with pre-existing CKD is~     associated with lower mortality. Chronic Renal Insufficiency Cohort (CRIC) is an ongoing~     observational study to examine the consequences of CKD with a particular focus on~     cardiovascular illness like myocardial infarction (heart attack) and stroke. Among CRIC study~     participants, the investigators propose to obtain visceral and subcutaneous adiposity and~     physical fitness measures and study its associations with patient-centered outcomes. This~     study will help the investigators understand the independent and combined effects of visceral~     adiposity and physical fitness on cardiovascular disease, renal disease progression and death~     among those with CKD. Further, it will identify mechanisms that could be targeted to reduce~     the detrimental effects of visceral adiposity in those with kidney disease.~   "
88734|NCT02405637|"~     The human fetus swallows over 200 ml of amniotic fluid per kilogram of weight each day and~     such swallowing is essential for normal small bowel development.Growth factors found in the~     amniotic fluid have been shown to promote proliferation of fetal intestinal cells. As feeding~     intolerance is a common problem among premature neonates, the investigators will study the~     role of enteral administration of simulated amniotic fluid solution in prevention of feeding~     intolerance and NEC in premature neonates.~   "
88735|NCT02405624|"~     Patients with infantile onset Pompe disease will be trained with continuous positive airway~     pressure to see if hypernasality can be improved.~   "
88736|NCT02405611|"~     This study is a longitudinal controlled trial that is designed to investigate the~     effectiveness of a multi-component intervention on improving fruit and vegetable consumption~     in teenagers and their mothers.~   "
88737|NCT02405598|"~     evaluate if beta 2-adrenergic agonist can have adjuvant effect to patients with~     infantile-onset Pompe disease under enzyme replacement therapy~   "
88738|NCT02405585|"~     Unfortunately, despite the best clinical efforts and breakthroughs in biotechnology, most~     patients diagnosed with pancreatic cancer continue to die from the rapid progression of their~     disease. One primary reason for this is that the disease is typically without symptoms until~     significant local and/or distant spread has occurred and is often beyond the chance for cure~     at the time of the diagnosis. The lack of any treatment to substantially increase long term~     survival rates is reflected by the poor outcomes associated with this disease, specifically~     time to disease progression and overall survival.~      However, another important part of the body is now being looked at as a target for therapy~     against this disease - the immune system. Scientists have clearly shown that pancreatic tumor~     cells produce a number of defective proteins, or express normal proteins in highly~     uncharacteristic ways, as part of this cancer. In some cancers, these abnormalities can cause~     an immune response to the cancer cells much in the way one responds to infected tissue. In~     progressive cancers however, the immune system fails to effectively identify or respond to~     these abnormalities and the cancer cells are not attacked or destroyed for reasons not yet~     fully understood. This clinical trial proposes a new way to stimulate the immune system to~     recognize pancreatic cancer cells and to stimulate an immune response that destroys or blocks~     the growth of the cancer.~      This new method of treatment helps the immune system of pancreatic cancer patients to~     identify the cancerous tissue so that it can be eliminated from the body. As an example,~     patients with certain diseases may require an organ transplant to replace a damaged kidney or~     heart. After receiving their transplant, these patients receive special drugs because they~     are at great danger of having an immune response that destroys or rejects the transplanted~     organ. This rejection occurs when their immune system responds to differences between the~     cells of the transplanted organ and their own immune system by attacking the foreign tissue~     in the same way as it would attack infected tissue. When the differences between foreign~     tissues and the patient's body are even larger, as with the differences between organs from~     different species, the rejection is very rapid, highly destructive, and the immunity it~     generates is longlasting. This is called hyperacute rejection and the medicine used to~     immunize patients in this protocol tries to harness this response to teach a patient's immune~     system to fight their pancreatic cancer just as the body would learn to reject a transplanted~     organ from an animal.~      To do this, Algenpantucel-L immunotherapy contains human pancreatic cancer cells that contain~     a mouse gene that marks the cancer cells as foreign to patient's immune systems. The immune~     system therefore attacks these cancer cells just as they would attack any truly foreign~     tissue, destroying as much as it can. Additionally, the immune system is stimulated to~     identify differences (aside from the mouse gene) between these cancer cells and normal human~     tissue as foreign. This education of the immune system helps treat the patient because~     pancreatic cancer cells already present in a treated patient are believed to show some of the~     same differences from normal tissue as the modified pancreatic cancer cells in the product.~     Due to these similarities, the immune system, once educated by the Algenpantucel-L~     immunotherapy, identifies the patient's cancer as foreign and attacks.~      Historically, external beam radiation has been part of the treatment of pancreatic cancer,~     both before and after surgical resection. Recent breakthroughs in technology now allow for~     more intensive doses of radiation to be delivered to the body with greater precision. These~     newer, more precise radiation treatments, called stereotactic body radiation, deliver more~     intensive radiation to a locally advanced tumor and are now being employed in the treatment~     of pancreatic cancer. Stereotactic body radiation may increase the chances that surgery will~     successfully remove a pancreatic cancer.~      In this experimental study, all patients will be given a strong combination of antitumor~     chemotherapy while receiving injections of an immunotherapy drug consisting of two types of~     pancreatic cancer cells that have been modified to make them more easily recognized and~     attacked by the immune system. The investigators propose to test this new treatment paradigm~     along with stereotactic body radiation in patients with borderline resectable pancreatic~     cancer to demonstrate that treatment with this combination of therapies increases the time~     until the tumor progresses as well as overall survival.~   "
88739|NCT02405572|"~     Crossover study of 2 infant formulas~   "
88740|NCT02405559|"~     The lymphatic system is one of the keystones of fluid homeostasis in the interstitium. In~     analogy with the arterial systolic pressure, the lymphatic pressure can give us information~     about the functioning of the cardiovascular system and fluid exchange. Actually, knowledge~     about this physiological parameter is incomplete because of the lack of technology. Former~     measurement techniques of the lymphatic pressure in the living healthy man were invasive and~     too complex to be interpreted.~      The lymphatic occlusion pressure has to be clarified because lymphedema treatment, concerning~     the pressure to be applied on the edematous tissue is still based on controversial concepts.~      On one hand, techniques such as Manual Lymphatic Drainage, sustain the necessity to apply a~     very low pressure in order to avoid the squeezing of superficial lymph vessels. On the other~     hand sustainers of Intermittent Compression Therapy advocate the necessity to apply~     relatively high pressure to obtain a decongesting effect. These completely opposite opinions~     triggered us to study lymphatic pressure more thoroughly.~      Lymphofluoroscopy (emerging imaging technique in the field of lymphology) is now used since 3~     years by the promoters of this study to visualize the architecture of the superficial~     lymphatic network and the progression of the lymph inside the highlighted vessels. This~     technique will be used in the present (prospective and multicentric) study to observe the~     effect of a pressure applied on the lower limb on the displacement of the lymph, and then to~     determine the occlusion pressure of the lymphatic vessels. The investigators already studied~     the occlusion pressure of the superficial lymphatic vessels of the upper limb in a previous~     study. The investigators would like to complete our results with the lower limb.~   "
88741|NCT02405546|"~     A nasal endotracheal tube (ETT) is routinely placed in children and a fiberoptic scope (FOS)~     is commonly used for this purpose. Resistance to the passage of ETT is frequently encountered~     as it is advanced over the FOS for placement into the trachea, since it gets hung up on~     structures of the laryngeal inlet. The aim of the investigators study performed on forty~     children divided in two groups was to study in the pediatric population, whether a 90°~     counterclockwise rotation (CCR) of the ETT prior to advancing through the larynx, by nasal~     approach, prevents it from getting hung up at the laryngeal inlet.~   "
88742|NCT02405533|"~     This is a phase II randomized, double-blind placebo-controlled, crossover trial. The primary~     outcome of this trial is achieving durable eradication persistent high risk HPV infection~     determined by HPV negative test results achieved while on active treatment with AHCC and~     maintained for 6 month post supplementation and 12 months post completion of AHCC treatment~     compared to placebo.~   "
88743|NCT02405520|"~     This phase I clinical study was designed to evaluate the safety and immunogenicity of the~     novel recombinant HPV type 6/11 bivalent vaccine, manufactured by Xiamen Innovax Biotech CO.,~     LTD., in healthy volunteers aged over 18-55 years of age at enrollment. The study volunteers~     will receive the 3 different formulations of the novel HPV vaccine or placebo administered~     intramuscularly according to a 0-1-6 month schedule.~   "
88744|NCT02405507|"~     Wheat germ is a by-product of the wheat-milling industry with high nutritional value and~     therefore could be used as a raw source for the preparation of food products such as bread,~     cookies, muffins, etc.~      The aim of this study is to assess the effects of ingesting wheat breads supplemented with~     wheat germ on gastrointestinal discomfort, blood cholesterol and postprandial glycaemic~     response in healthy human volunteers.~   "
88745|NCT02405494|"~     Liquid foams can be formed by trapping pockets of gas in a beverage. The primary objective of~     this study is to test the individual contribution, and possible interaction, of the liquid~     volume and gas to liquid volume ratio (i.e. %overrun (%OR, defined as 100 x [gas~     volume/liquid volume]) of a beverage to its satiating properties.~   "
88746|NCT02405481|"~     The study evaluates the effectiveness of SEPA (Salud, Educacion, Prevencion y Autocuidado;~     Health, Education, Prevention and Self-Care) to increase HIV prevention behaviors and to~     reduce the incidence of STIs for Hispanic women when delivered in a real-world setting by~     community agency personnel. The study recruits Hispanic women between the ages of 18 and 50~     who are sexually active and are randomized to either SEPA or a Wait-List Control condition.~   "
88747|NCT02405468|"~     The investigators want to compare blood microbiota profile between patients with documented~     coronary lesions and patients free of coronary disease.~   "
88748|NCT02405455|"~     Cervical insufficiency (CI), responsible for 8% of preterm births (PB), is used to describe~     painless cervical dilation leading to recurrent second-trimester pregnancy losses/births of~     otherwise normal pregnancies. Structural weakness of cervical tissue was thought to cause or~     contribute to these adverse outcomes. The term has also been applied to women with one or two~     such losses/births or at risk for second-trimester pregnancy loss/birth. Cervical pessary and~     cervical cerclage are both considered as preventive treatments in women at risk for PB. This~     study aims to demonstrate that the cervical pessary could reduce the preterm birth rate~     before 37 weeks of gestation in women with prior PB due to cervical insufficiency or in women~     with prior PB and a short cervix in the current pregnancy.~   "
88749|NCT02405442|"~     This study will primarily evaluate the safety and efficacy of GS-5745 in adults with active~     Crohn's disease. The study will consist of a Blinded Treatment Period of 8 weeks followed by~     an Open Label Extension. Participants who complete the Blinded Treatment Period will be~     eligible to enroll in the optional Open Label Extension for an additional 44 weeks.~     Participants who complete Week 52 assessments will be eligible to enter the Extended~     Treatment Phase to continue treatment with GS-5745 for an additional 156 weeks.~   "
88750|NCT02405429|"~     The aim of this study was to evaluate the temporal artery thermometer by comparing temporal~     artery and axillary thermometer temperature measurements with rectal thermometer temperature~     measurements in neonatal patients. The investigators measured temporal artery, axillary, and~     rectal temperatures of 49 infants. Temporal artery temperature was measured using an infrared~     temporal artery thermometer, and the results with this device were compared with axillary~     temperature (clinical standard) and rectal temperature (gold standard). The difference~     between rectal and temporal artery temperatures was compared with the difference between~     rectal and axillary temperatures for each infant, and the data were analyzed based on weight,~     postmenstrual age and bed type - open crib or incubator.~   "
88751|NCT02405416|"~     This clinical trial aims to compare infrahepatic inferior vena cava clamping (IIVCC) with~     selective hepatic vascular exclusion (SHVE) involving the portal triad clamping (PTC) in~     complex cirrhotic liver resection. One group will receive IIVCC plus PTC, while an another~     equivalent group patients will be operated using SHVE and PTC.~   "
88752|NCT02405403|"~     Neuroinflammation, characterized in particular by microglia activation, is an essential~     component of Amyotrophic Lateral Sclerosis (ALS) pathogenesis. Translocator Protein (TSPO) is~     recognized as a specific and sensitive biomarker of neuroinflammation, reflecting disease~     activity. An experimental radiopharmaceutical specific of TSPO expression, namely~     [18F]DPA714, allow to quantify this microglial activation using Positon Emission Tomography~     (PET) imaging.~      The purpose of this study is to longitudinally correlate the spatial distribution of~     neuroinflammation with the pro- or anti-inflammatory state of activated microglia cells in~     ALS, in order to evaluate neurotoxic or neuroprotective microglia activity, by complementary~     approaches in 20 ALS patients:~        -  in vitro: measuring concentrations of several pro- and anti-inflammatory cytokines~          secreted by microglial cells in the cerebrospinal fluid (CSF).~        -  in vivo: [18F]DPA714 PET imaging. These assays will be performed in the framework of the~          clinical follow-up of ALS patients, at the diagnosis of ALS disease and 6 months latter.~   "
88753|NCT02405390|"~     The purpose of this study is to evaluate if intubation with video laryngoscopy (VL) will~     result in less head motion and therefore less cervical motion when compared with direct~     laryngoscopy (DL).~      The aim of the study is to determine the amount of head motion (extension, flexion and~     rotation) when using Storz C-Mac® video laryngoscopes and direct laryngoscopes. Secondarily,~     the study will also measure the number of attempts to properly intubate and the time required~     for intubation with either technique.~   "
88754|NCT02405377|"~     Patients at moderate and high risk for contrast induced nephropathy (CIN) should receive~     sufficient hydration before application of contrast to prevent CIN, but hydration could~     obviously increase the preload for congestive heart failure (CHF) patients. It is important~     to make an individual hydration protocol for patients with dysfunction of heart and renal to~     reduce the incidence rate of CIN. This prospective, randomized, double-blind, comparative~     clinical trial randomly selected 264 patients with estimated glomerular filtration rate,~     (eGFR) <60 ml/min per 1.73 m2 and CHF undergoing coronary angiography to receive either the~     convention hydration (n=132) or the central venous pressure (CVP) guided hydration (n=132).~   "
88755|NCT02405364|"~     The purpose is to determine whether induction and consolidation treatment with Carfilzomib,~     Lenalidomide and Dexamethasone (CRd), within an intensive program, warrant further~     investigation in clinical trials.~   "
88756|NCT02405351|"~     The investigators propose to develop a Telerehabilitation approach to working memory training~     for patients experiencing working memory deficits post stroke. The investigators have~     currently developed a game-like computerized working memory training program that can be~     accessed via the internet for research purposes. The investigators propose to refine the~     website to focus more on clinically based training, and to evaluate the feasibility and~     initial effectiveness of this approach in a pilot study with participants after stroke.~   "
88757|NCT02405338|"~     This is a multi-centre, open label, prospective, non-randomized phase I/II trial in 20~     patients including a safety-run in phase I part comprising 6 patients.~      Trial subjects will receive repeated immunotherapies with autologous Dendritic Cells (DCs),~     presenting two leukemia-associated antigens.~   "
88758|NCT02405325|"~     Older adults are the least active population group in the US. Yet, research has shown that an~     increase in physical activity (PA) can have immediate and profound effects on cardiovascular~     health. Older adults who are active use significantly fewer health care resources, and with~     the increasing number of older adults in the US it is imperative to curb health care~     expenditure in this group. PEP4PA (Peer Empowerment Program 4 Physical Activity) is a~     multilevel intervention aimed at increasing physical activity levels in a population of low~     income and ethnically diverse older adults. It will be delivered in centers by trained older~     adults. Participants will work towards a daily increase of 2000 steps per day through~     self-paced incidental walking, peer led group walks, and attendance at existing center PA~     classes. They will also work on projects to increase opportunities to be physically active at~     their center or in the surrounding neighborhood.~   "
88759|NCT02405312|"~     This year, 90,000 Americans with end-stage renal disease (ESRD) will die and questions will~     legitimately be raised as to whether terminal treatment and location of death adequately~     represented their preferences. These concerns are linked by a failure on the part of patients~     and staff to discuss prognosis and share in end-of-life (EOL) planning. The rate of hospice~     use among patients dying with ESRD is half that of the national average and one-quarter the~     rate for patients with terminal cancer. In other patient populations when meaningful EOL~     conversation occurs this is associated with increased hospice referral and improved quality~     of the dying.~      Patients receiving hemodialysis (HD) often desire but rarely communicate with staff about~     prognoses, know little about availability of community hospice resources, or how to complete~     advance directives. Nephrologists are not trained to have these conversations, and although~     accustomed to relying on interdisciplinary teams, they are unaccustomed to collaborating with~     community hospices. Our preliminary research began by using focus groups, created and~     validated the first clinically useful HD prognostic tool, and developed a prototype for~     Shared Decision Making and Renal Supportive Care (SDM-RSC). This is a novel multimodal~     intervention that familiarizes patients, families, and dialysis staff with community hospice~     resources, emphasizes dialysis social work support, conveys information about terminal care~     issues, and encourages advance care planning.~      The proposed study tests the central hypothesis that EOL care can be improved by relying on~     patients and stakeholders to enhance SDM-RSC for HD patients who are most likely to die. It~     will test whether an intervention that targets communication deficiencies can alter EOL~     outcomes and achieve the goal of matching patient preferences with terminal treatments.~   "
88760|NCT02405299|"~     This research aims to assess the cognitives rehabilitations in attention deficit disorder~     (ADHD) in children. the objective is to demonstrate what are the most relevant cognitive~     factors for rehabilitative to improve the inhibition of disorders in ADHD.~   "
88761|NCT02405286|"~     This study aimed to Assess the validity of the Rockall score for the prediction of rebleeding~     and death in patients with upper gastrointestinal bleeding.~   "
88762|NCT02405273|"~     Lung cancer is the leading cause of cancer death in males, and is increasing in females. Up~     to 73% of affected patients present with Chronic Obstructive Pulmonary Disease (COPD). Most~     lung cancer patients have an average survival of about 8 months from diagnosis. Lobectomy for~     initial stages has demonstrated higher survival rates, but only 15% to 25% are surgical~     candidates; unfortunately, cardiopulmonary impairment mainly due to coexisting COPD reduces~     this number and patients undergo medical treatment or marginal lung resection, with minor~     functional impact but possible ineffective control of disease.~      Furthermore, COPD is associated with increased postoperative morbidity and mortality, longer~     in-hospital stay, need for additional treatments, and a rise in sanitary costs.~      The investigators planned a randomised trial on surgical candidates to assess the effect of~     comprehensive pulmonary rehabilitation on functional and surgical outcomes, functioning, and~     Quality of Life (QoL).~   "
88763|NCT02405260|"~     This trial is a multi-center, adaptive, randomized, double-blind, placebo- and active-~     controlled, parallel group, Phase 2 study in subjects with T2DM to evaluate the effect of~     TTP399 on HbA1c following administration for 6 months.~   "
88764|NCT02405247|"~     The aim of this study is to evaluate clinical outcomes of 2nd line therapy in NSCLC patients~     without the T790M mutation, both independently and when compared indirectly with NSCLC~     patients with the T790M mutation in the T STAR non interventional study (D5160R00001).~      The patient population in the TAURAS study will consist of patients who fail screening for~     AURA3 (D5160C00003) due to a T790M mutation not detected using the central cobas® EGFR~     Mutation Test (Roche Molecular Systems).~   "
88765|NCT02405234|"~     The proportion of patient successes with the Carbon Modular Radial Head at the 2-year~     evaluation is no lower than the proportion of patient successes with the Metal Radial Head.~   "
88766|NCT02405221|"~     This study will be looking at what dose of the TA-CIN vaccine is safe and effective in~     patients with a history of HPV16 associated cervical cancer.~   "
88767|NCT02405208|"~     This study is designed as a multi-center, nonrandomized, uncontrolled, unblinded, prospective~     clinical outcomes investigation to evaluate the short, mid and long term performance of the~     PyroTITAN™ HRA Shoulder prosthesis humeral replacement.~   "
88768|NCT02405195|"~     Acute kidney injury is a common complication after cardiac surgery with cardiopulmonary~     bypass (CPB). This study aims to investigate the effects of CPB on renal perfusion,~     filtration and oxygenation.~   "
88769|NCT02405182|"~     Amyotrophic lateral sclerosis (ALS) is a disabling and rapidly progressive neurodegenerative~     disorder. There is no treatment that significantly slows progression. Increasing age is an~     important risk factor for developing ALS; thus, the societal impact of this devastating~     disease will become more profound as the population ages. A significant hurdle to finding~     effective treatment has been an inability to accurately measure brain degeneration in humans.~     Advanced magnetic resonance imaging (MRI) techniques hold promise in this respect, and may~     assist in aiding diagnosis and the efficient testing of new drugs.~      Different MRI features of brain degeneration will be measured in a large sample of patients~     with ALS. The study will operate within the Canadian ALS Neuroimaging Consortium (CALSNIC).~     CALSNIC is a clinical research platform comprised of ALS clinics with standardized clinical~     and neuroimaging protocols.~   "
88770|NCT02405169|"~     The primary objective of the present study is to evaluate the marginal bone level changes~     occurring in total edentulous patients treated with six or four implants.~      Secondary objective~        -  overall survival rate~        -  soft tissue status by assessment of bleeding on probing (BoP) and probing pocket depth~          (PPD) at baseline and after 1,3,5 years~        -  prosthetic survival rates including screw or abutment loosening, framework or veneer~          fractures~   "
88771|NCT02405156|"~     To compare the success rate of letrozole and misoprostol versus misoprostol alone for medical~     termination of pregnancy in second trimester abortion.~   "
88772|NCT02405143|"~     Occipital stroke is associated with homonymous visual field defects (occurring on one side of~     the visual field). Despite spontaneous recovery, some degree of defect is often permanent.~     Currently, no treatment exists for such visual field defects.The purpose of this study is to~     test the efficacy of a type of electrical brain stimulation method, transcranial alternating~     current stimulation, in reducing these type of visual field defects in their chronic stage.~   "
88784|NCT02404987|"~     Post-marketing observational study of a nutritional care plan, including a higher calorie,~     higher protein oral nutritional supplement (ONS), prescribed to Spanish patients, both free~     living and residing and nursing homes, who have been identified as malnourished. The~     objective is to assess the impact of the ONS on body weight, activities of daily living and~     quality of life.~   "
88773|NCT02405130|"~     Primary percutaneous coronary intervention (PPCI) is the preferred reperfusion strategy for~     treating acute ST-segment elevation myocardial infarction (STEMI). The main goals are to~     restore epicardial infarct-related artery patency and to achieve microvascular reperfusion as~     early as possible. No-reflow is the term used to describe inadequate myocardial perfusion of~     a given coronary segment without angiographic evidence of persistent mechanical obstruction~     of epicardial vessels and it refers to the high resistance of microvascular blood flow~     encountered during opening of the infarct-related coronary artery.~      Despite optimal evidence-based PPCI, myocardial no-reflow can still occur, negating many of~     the benefits of restoring culprit vessel patency, and is associated with a worse in-hospital~     and long-term prognosis. Several strategies have been tested to revert the no-reflow~     including the use of thrombectomy, glycoprotein IIb/IIIa inhibitors and the use of~     intracoronary adenosine, but none has been demonstrated to effectively counteract the~     phenomenon.~      The trial aims to show the effect of the administration of intracoronary adrenalin on~     myocardial reperfusion assessed by magnetic resonance in patients with STEMI undergoing PCI~     and with persistent coronary angiographic The Thrombolysis in Myocardial Infarction (TIMI)~     0-1 flow during the interventional procedure after failure of standard therapy.~   "
88774|NCT02405117|"~     This study will develop and pilot a smartphone intervention, LiveWell, to enhance patient~     self-management of bipolar disorder and facilitate more efficient, timely care delivery by~     mental health providers. The intervention uses a mobile application to collect daily~     self-report and continuous behavioral data and adapts intervention content to create a highly~     tailored and user-responsive treatment system. Patient data collected by the phone will also~     be provided to clinicians to allow for better evaluation and targeting of treatment. The goal~     is to reduce symptoms and prevent relapse in patients with bipolar disorder.~   "
88775|NCT02405104|"~     The purpose of this study is to elucidate whether patients operated with THA and TKA can~     benefit from treatment with chlorzoxazone.~   "
88776|NCT02405091|"~     Phase 3, open-label, study to evaluate the safety and tolerability of NBI-98854 administered~     once daily (qd) for a total of 48 weeks of treatment. This study will enroll approximately~     150 medically stable male and female subjects with clinical diagnoses of schizophrenia or~     schizoaffective disorder with neuroleptic-induced TD or mood disorder with~     neuroleptic-induced TD.~   "
88777|NCT02405078|"~     The goal of this clinical research study is to learn if performing blood tests and imaging~     scans at different time points during chemotherapy can help researchers predict if patients~     with DLBCL will respond to treatment.~   "
88778|NCT02405065|"~     The main objective of this study is to determine the maximum tolerated dose (MTD) and~     recommended phase 2 dose of HM95573.~   "
88779|NCT02405052|"~     Panic-like anxiety ( panic attacks with or without panic disorder), a highly treatable~     condition, is the most prevalent condition associated with unexplained chest pain in the~     emergency department. Panic-like anxiety may be responsible for a significant portion of the~     negative consequences of unexplained chest pain, such as functional limitations and~     chronicity. However, more than 92% of panic-like anxiety cases remain undiagnosed at the time~     of discharge from the emergency department. The 4-item Panic Screening Score questionnaire~     was derived in order to increase the identification of panic-like anxiety in emergency~     department patients with unexplained chest pain.~      The goals of this prospective cohort study are to (1) refine the Panic Screening Score; (2)~     validate the revised version of the Panic Screening Score; (3) measure the reliability of the~     revised version of the Panic Screening Score and (4) assess the acceptability of the~     instrument among emergency physicians.~   "
88780|NCT02405039|"~     This is a randomized, double masked study designed to evaluate the safety of EBI-005 5 mg/mL~     topical ophthalmic solution given three times daily (TID) compared to vehicle-control over a~     one year period in subjects with dry eye disease (DED). Approximately 188 subjects will be~     enrolled to either EBI-005 or vehicle at up to 15 centers in the United States (US) and~     Canada.~   "
88781|NCT02405026|"~     The purpose of this study is to determine the prevalence and severity of asthma in patients~     with HIV. To determine the immunological phenotype of HIV-infected patients with asthma.~   "
88782|NCT02405013|"~     Primary Objective:~      To evaluate the efficacy (sustained virological response 12 weeks after end-of-treatment~     [SVR12]) of 12-week course of an interferon-free regimen combining sofosbuvir and~     weight-dosed ribavirin (genotype 2), or sofosbuvir and ledipasvir (genotype 1 or 4) in~     treatment-naïve patients infected with HCV genotype 1, 2 or 4 in West and Central Africa~      Secondary Objectives:~        1. To estimate the study treatment SVR24 rate~        2. To evaluate the clinical and biological tolerance of study treatment~        3. To describe HCV kinetics under HCV treatment, and identify associated factors~        4. To describe the evolution of HIV disease under HCV treatment in HVC-HIV co-infected~          patients~        5. To describe the changes of liver fibrosis based on non-invasive tests between treatment~          initiation, week 24, and week 36 after treatment, and estimate its association with~          SVR12 or SVR24~        6. To identify factors associated with SVR12 and SVR24 (including HIV status)~        7. To evaluate the performance of a nanodevice for rapid diagnosis of HCV viral load and~          genotypying and for assessing response to treatment (SVR12 and SVR24)~        8. Facilitate the detection and treatment of those infected with HCV by supporting national~          initiatives for access to strategies without interferon~        9. To set up a HCV clinical research network across French and English-speaking African~          countries, able to run large-scale comparative randomized clinical trials in a near~          future.~   "
88783|NCT02405000|"~     The objective of this research is to perform a pilot study on patients undergoing~     laryngoscopy for diagnostic and tumor staging purposes (for pharyngeal or laryngeal cancer)~     in which intraoperative CT imaging will be performed both prior to (but after induction of~     general endotracheal anesthesia) and during placement of the laryngoscope in order to better~     understand anatomic changes that occur during instrumentation of the oral cavity and~     oropharynx. The goals of the study are:~        1. Develop a suite of de-identified images and surface renderings that qualitatively show~          how a tumor and the upper aerodigestive tract anatomy deform during a laryngoscopic~          evaluation.~        2. Create deformation models of the upper aerodigestive tract.~      This data to be used for future retractor development as well as for virtual image guided~     surgery.~   "
88785|NCT02404974|"~     The purpose of this pilot study is to assess the feasibility, acceptability, and potential~     effectiveness of identifying people with osteoarthritis (OA) who are interested in~     individualized exercise programs through a web-based osteoarthritis application; assessing~     their exercise barriers, facilitators, motivators and preferences; and engaging them in an~     exercise program tailored to meet their needs by a Certified Fitness Trainer.~   "
88786|NCT02404961|"~     The investigators plan to study the etiology of vulvodynia, a condition characterized by~     chronic vulvar discomfort, most often described as burning pain, occurring in the absence of~     relevant visible findings or a specific, clinically identifiable, neurologic disorder. Our~     hypothesis is that vulvodynia is the result of an altered immuno-inflammatory response~     mechanism that occurs as a consequence of reproductive, gynecologic, environmental, or~     psychological exposures, with abnormal vaginal microflora and genetic polymorphisms as~     potential modifiers of the effects of interest. Therefore, the investigators propose to~     collect information about reproductive, gynecological and environmental exposures,~     psychological trauma and psychiatric morbidity, and biological markers of immuno-inflammation~     and nerve fiber proliferation.~   "
88787|NCT02404948|"~     This is a validation study comparing a pulse wave based algorithm for the detection of~     coronary artery disease with parameters from coronary angiography, echocardiography and~     cardiogoniometry.~   "
88788|NCT02404935|"~     National multicentric phase II trial evaluating whether single agent cetuximab is effective~     as maintenance therapy after 8 cycles of first line FOLFIRI plus cetuximab in mCRC patients~     with KRAS and NRAS wild-type genes, assessed by progression-free survival at 6 months after~     start of maintenance therapy.~   "
88789|NCT02404922|"~     This study will assess in healthy male and female subjects the safety, tolerability and~     pharmacokinetics (PK) profiles of Immediate Release CTP-730 at steady state following 7 days~     of dosing. Three doses of Immediate Release (IR) CTP-730 capsules will be studied.~   "
88790|NCT02404909|"~     The aim of this study was to evaluate whether IVC index measured intraoperatively was~     affected by fluid administration and could add any helpful information about the hemodynamics~     during hepatic resection. In addition, the investigators evaluated whether IVC index was~     somehow correlated with the risk of postoperative complication.~   "
88791|NCT02404896|"~     Metreleptin was approved in the United States as adjunct to diet as replacement therapy to~     treat the complications of leptin deficiency in patients with congenital or acquired~     generalized lipodystrophy in February 2014. The approval was based on results obtained in 2~     open-label, investigator-sponsored studies (Studies 991265 and 20010769) conducted at the~     National Institutes of Health (NIH) to evaluate the safety and efficacy of metreleptin~     treatment in patients with lipodystrophy and 1 treatment IND (FHA101/MB002-002/MB002-002)~     conducted by Bristol-Myers Squibb on behalf of AstraZeneca (BMS/AZ) in patients with diabetes~     mellitus and/or hypertriglyceridemia related to lipodystrophy. These studies enrolled~     patients with lipodsytrophy including both generalized and partial lipodystrophy. Although~     the marketing authorization restricted the indication to patients with generalized~     lipodystrophy, meaningful clinical benefit was achieved in a subset of patients with partial~     lipodystrophy, and these patients from FHA101/MB002-002 form the basis of the request for~     ongoing treatment under expanded access.~   "
88792|NCT02404883|"~     Women who are diagnosed with cancer during their reproductive lifespan might be confronted~     with impaired fertility. Nowadays a number of fertility preservation options are available.~     Decisions about whether and how to protect fertility have to be made in a very short time~     period, right after cancer diagnosis and before start of treatment. The psychological impact~     for patients is considerable. This project aims at developing a standardized decision-aid~     tool to support the decision-making process about fertility preservation in young cancer~     patients. It is designed as an online decision-aid tool. A web-based tool is perfectly~     designed for this target group and offers new possibilities providing flexible and~     individually tailored information.~      The aim of the study is to examine the benefits of the online decision-aid tool compared with~     standard counseling (usual care). Decisional conflict is measured immediately after~     counseling as well as one month later. One year after counseling, decisional regret is being~     evaluated additionally. If the decision-aid tool proves to be helpful and useful, the online~     design allows making it available for a wide range of concerned patients.~   "
88793|NCT02404870|"~     Background:~      - Canagliflozin (sold as InvokanaTM) is a new medicine for diabetes. But it might increase~     the bone fracture risk in people with diabetes.~      Objective:~      - To see if Invokana has negative side effects on bone health.~      Eligibility:~      - Healthy men ages 18 45.~      Design:~        -  Participants will be screened with a medical history, physical exam, and blood tests. A~          nutritionist will discuss their dietary history and the study dietary requirements.~          Participants will get a food diary to record what they eat and drink on 3 separate days.~        -  Participants will have a DEXA scan x-ray test of bone health. Participants will lie~          still on a table while a small camera passes over the body.~        -  Participants will have 2 stays in the clinic. They will be 1 week apart and each last 6~          overnights starting on a Sunday.~        -  Before each stay, participants will:~        -  Pick up food each day for 7 days. They will get breakfast, lunch, dinner, and snacks.~          They must eat only the food provided during these times.~        -  Collect their urine twice.~        -  During the stays, participants will:~        -  Be evaluated by a doctor and have blood drawn.~        -  On each Monday, participants will:~        -  Skip breakfast~        -  At about 8 a.m. take a placebo pill in one stay, the study drug in the other stay.~        -  Drink 6 ounces of water every 2 hours for 4 hours.~        -  An intravenous (IV) catheter will be inserted into an arm. Blood will be drawn every 2~          hours from 8 a.m. until noon.~        -  Get lunch.~        -  Have blood testing again at 8pm and midnight.~        -  Repeat the testing days 2 5.~        -  Have urine collected.~   "
88794|NCT02404857|"~     The goal is to evaluate the potential of a EEG based BCI (Brain-Computer-Interface) connected~     to a non-invasive pneumatic glove for rehabilitation of hand-movements post-stroke.~   "
88795|NCT02404844|"~     This is a clinical trial with a molecularly stratified parallel cohort, single arm design to~     explore the efficacy and safety of BKM120 in combination with tamoxifen in patients with~     ER/PR-positive, HER2-negative breast cancer with prior exposure to antihormonal therapy, and~     different biomarker profiles, two of them potentially indicative of constitutive PI3K pathway~     activation.~   "
88798|NCT02404805|"~     The investigator believes simeprevir concentrations are unchanged when administered in~     combination with dolutegravir relative to administration alone. The investigator believes~     dolutegravir concentrations are unchanged when administered in combination with simeprevir.~     Additionally, the investigator believes simeprevir and dolutegravir are safe when~     administered alone and in combination.~   "
88799|NCT02404792|"~     The primary objective of this proposal is to compare a moderate or high intensity exercise~     intervention to improve physical function in persons aging with Human Immunodeficiency Virus~     (HIV).~   "
88800|NCT02404779|"~     Severely brain injured patients are at high risk of intracranial hypertension. Among medical~     treatments (sedatives), neuromuscular blocking agents (NMBA) are recommended by french but~     not english speaking societies.~      Effects of NMBA are unknown. The present study is designed to compare the effects of NMBA~     versus placebo in the treatment of intracranial hypertension, and the underlying~     physiopathologic effects.~   "
88801|NCT02404766|"~     C1-C2 is the most mobile segment of the spine and its dysfunction is frequently associated to~     cervical pain and headache. However, serious neurovascular adverse effects have been~     documented through direct treatment of C1-C2 segment. Although indirect treatment via~     adjacent segments and avoidance of end range of rotation and extension have been recommended~     for a safer and effective cervical treatment, there is no scientific evidence of the~     effectiveness of the indirect treatment approach in the cervical neutral position for C1-C2~     hypomobility.~      Due to that, the investigators designed a randomized controlled trial to compare the~     short-term effects in the Flexion Rotation Test (FRT) of a translatoric mobilization of~     C0-C1, a translatoric mobilization of C7-T1 and a control group in subjects with C1-C2~     hypomobility.The primary hypothesis is that C0-C1 dorsal glide mobilization applied in the~     neutral cervical position can recover the C1-C2 rotational range of movement in subjects with~     upper cervical hypomobility.~   "
88802|NCT02404753|"~     The purpose of the study is to evaluate the safety and efficacy of laparoscopic distal D2~     gastrectomy (LDG) compared with open surgery (ODG) for resectable gastric cancer, to~     determine whether LDG can be a test arm for a future Phase III trial to evaluate the~     non-inferiority of overall survival compared with ODG in patients who receive neoadjuvant~     chemotherapy.~   "
88803|NCT02404740|"~     Using a pulse oximeter, we have developed an algorithm that estimates intracranial pressure~     (ICP) based on patients who have had traumatic brain injuries. Patients with hydrocephalus~     are typically treated with a shunt in order to reduce ICP. At times the shunt can~     malfunction. We believe that our algorithm will help identify when a hydrocephalus patient's~     shunt has malfunctioned.~   "
88804|NCT02404727|"~     The aim of this project is to investigate prosthesis fixation in the bone, respectively~     cemented and uncemented operation method of Avantage® dual-mobility acetabular cup in elderly~     patients, wear of the plastic in dual-mobility hip prosthesis and evaluate the clinical~     function, patient satisfaction and possible complications.~      Patients included in this study suffer from osteoarthritis of the hip.~   "
88805|NCT02404714|"~     This is an observational comparative study to compare the standard-of-care methods for sweat~     testing used to support diagnosing cystic fibrosis (CF) against a new method of sweat testing~     called the CF Quantum Sweat Test System. The results of the new device in this study are for~     comparison ONLY and will NOT be used to diagnose, treat or mitigate the subject's condition.~   "
88806|NCT02404701|"~     The purpose of this study is to ascertain whether certain supplements promote excessive~     urinary oxalate excretion and increase the risk for calcium oxalate kidney stones.~     Supplements that enhance urinary oxalate excretion, as a result of their oxalate~     concentration or from some other mechanism (e.g., providing substrate for oxalate~     biosynthesis) will be identified by the investigators.~   "
88807|NCT02404688|"~     The overarching goal of this study is to characterize the effects of ethanol and cannabinoids~     on simulated driving and related cognition.~   "
88808|NCT02404675|"~     This randomized, open-label study is aimed to evaluate the efficacy of high-dose icotinib in~     treating advanced non-small cell lung cancer patients with positive EGFR 21 exon mutation.~   "
88809|NCT02404662|"~     Most patients who present with problem drinking also present with mood problems. Problem~     drinking and mood problems co-occurring together in individuals lead them to have more severe~     symptoms, greater disability and poorer quality of life than individuals with only problem~     drinking, and they pose a greater economic burden to society due to their higher use of~     health services. This study aims to assess the efficacy of a new, innovative and cost~     effective treatment strategy aimed at reducing the burden that these co-occurring conditions~     impose on the suffers and their families as well as the community and health systems.~      In a recent pilot study of supportive text messages for patients with problem drinking and~     co-occurring depression, the investigators established that patients who received twice daily~     supportive text messages for three months had significantly less depressive symptoms than~     those who did not receive such messages. There was also a trend to finding that patients who~     received the supportive text messages were more likely to have higher alcohol free days than~     those who did not receive any supportive text messages.~      This study seeks to extend the knowledge gained from the pilot study. A larger group of~     patients with alcohol use disorder and a depressive disorder will be randomly assigned to two~     groups. One group will receive supportive text messages for six months duration whilst the~     other group will receive no supportive text messages. The patients will be followed up at 3,~     6, 9 and 12 months to determine which of the two groups have less alcohol and mood problems.~     It is anticipated that patients receiving supportive text messages will report significantly~     greater alcohol free days as well as significantly less relapses, hospitalizations and mood~     symptoms than those not receiving such messages.~   "
88831|NCT02404376|"~     Remote ischemic conditioning (RIC) and intravenous exenatide administered immediately before~     primary angioplasty have been found to limit infarct size in patients with STEMI (ST segment~     elevation myocardial infarction), but the reduction is limited. This study investigates~     whether a combination therapy including both therapies is more effective.~   "
88894|NCT02403557|"~     The purpose of this study is to determine whether tailored internet-administrated cognitive~     behaviour therapy (ICBT) is a feasible approach in the treatment of anxiety symptoms and~     comorbid depressive symptoms in older adults.~   "
88810|NCT02404649|"~     This is a research study to test the clinical outcome of Trabecular Metal™ Dental Implants~     (TMDI) (Zimmer Dental Inc Carlsbad, CA, US) in the Maxillary Sinus region. This project will~     enroll 30 active subjects who will receive two dental implants in the edentulous maxillary~     molar region. This 24-month research study will examine the clinical stability of TMDI in~     both sinus elevation and sinus augmentation environments. The proposed research lays the~     foundation for improved health care by providing surgeons and restorative dentists with data~     for determining the effects TMDI have on clinical success in less than optimal osseous~     environments. The rationale that underlies the investigation is that identification of the~     influences of trabecular surface design on implant stability in varying bone types will allow~     routine, predictable use of early loading, which, in turn, will translate into more rapid,~     economical health care, and improved psychosocial well-being of the patient. If these~     hypotheses are correct, the results are expected to provide evidence based research data to~     support early loading and immediate loading of single implants in sites of adequate bone~     volume, and density with or without the use of graft materials in sinus lift procedures. In~     addition, it is expected that these results will fundamentally advance the field of implant~     dentistry and bioengineering by providing information on the principles of the bone~     density-mechanical environment-implant stability interaction.~   "
88811|NCT02404636|"~     ADDUP is an observational study of patients with alcoholic hepatitis. A structured interview~     is used to quantitatively estimate:~        1. Alcohol use~        2. Dietary intake~        3. Drug use (legal and illegal)~      in the weeks preceding onset of acute alcoholic hepatitis. After interview patients are~     followed up for 12 months with regard to response to therapy and survival.~      The study is intended to explore potential precipitants of alcoholic hepatitis.~   "
88812|NCT02404623|"~     This trial objective is to assess whether doubling the daily intake of vitamin D improves~     serum vitamin D levels and serves as primary prevention of respiratory infections and asthma~     in premature infants.~      This is a prospective randomized (1:1) double-blinded trial.~      The study population will be randomized into two groups (1:1):~        -  Intervention Group - 800 IU of Vitamin D once daily~        -  Control Group - 400 IU of Vitamin D once daily Patients will be followed up for one year~          after randomization for serum Vitamin D levels and respiratory morbidity.~   "
88813|NCT02404610|"~     This study is a clinical trial of moderate sedation versus deep sedation with propofol for~     procedural sedation in the Emergency Department. The purpose of this study is to compare the~     rate of amnesia and respiratory depression rate in patients who receive moderate sedation to~     those that receive deep sedation.~   "
88814|NCT02404597|"~     The purpose of this study is to describe the use of non-invasive cardiac output monitors~     (NICOM) in patients with burn injuries and to develop a protocol for NICOM in a burn unit.~   "
88815|NCT02404584|"~     The primary objective of this study is to determine the percentage of patients with a plasma~     concentration of sunitinib remaining at equilibrium ([Suni]REq) greater than 100 ng / ml~     (effective concentration according to the current literature).~   "
88816|NCT02404571|"~     This study is to evaluate the efficacy and safety of GDP (gemcitabine, dexamethasone, and~     cisplatin) chemotherapy in patients with peripheral T-cell lymphoma-NOS as frontline~     treatment.~   "
88817|NCT02404558|"~     Primary Objective:~      To describe the safety and tolerability, including laboratory abnormalities following a~     single dose of sarilumab or tocilizumab administered subcutaneously (SC) as monotherapy in~     Japanese patients with rheumatoid arthritis (RA).~      Secondary Objectives:~      To describe the laboratory abnormalities (absolute neutrophil count [ANC], platelet counts,~     total cholesterol, high-density lipoprotein [HDL] cholesterol, low-density lipoprotein [LDL]~     cholesterol, and liver function tests [LFTs]) following a single dose of sarilumab or~     tocilizumab administered SC as monotherapy in Japanese patients with RA.~      To describe the pharmacokinetics (PK) of sarilumab and tocilizumab.~   "
88818|NCT02404545|"~     Concurrent placement of a mesh during formation of ileal conduit will decrease the incidence~     of parastomal hernia and associated complications.~   "
88819|NCT02404532|"~     The purpose of this study is to determine the accuracy of IEM detection by the MIND1 System~     by completing a series of Patch applications and IEM ingestions in the clinic.~   "
88820|NCT02404519|"~     Vitamin K is required for the activation of the inhibitor of vascular calcification: Matrix~     Gla Protein (MGP). In an earlier study the beneficial effect of menaquinone-7 (MK-7), a~     vitamin K2 form, was observed on the stiffness of the vessel wall in postmenopausal women. It~     decreased the circulating form of inactive MGP and improved the vascular elasticity (local)~     and aortic pulse wave velocity (regional). The decrease of circulating inactive MGP was~     observed after 2-3 months MK-7 supplementation and the effect of MK-7 on the clinical~     endpoints was observed within 3 years of supplementation. It is demonstrated in several~     studies that cardiovascular risk increases with decreasing vitamin K intake and increasing~     levels of inactive MGP. In this study the investigators select subjects in the highest~     tertile of circulating inactive MGP. This study group will consist of subjects with increased~     cardiovascular risk and it is expected that effects of MK-7 on clinical endpoints in this~     group will be measurable within 1 year of supplementation.~      Vascular stiffness can be determined with different techniques. The vascular characteristics~     determined with Pulse Wave Velocity (PWV), ultrasound of the common carotid artery and~     accelerated plethysmography (APG) with a fingertip device will be compared in a follow-up~     study.~   "
88832|NCT02404363|"~     Clopidogrel has been shown to slow down tumor progression in orthoptic pancreatic murine~     tumor.~      In a pilot study, the rate of microparticles was correlated with response rate of pancreatic~     adenocarcinoma.~      The aim of the study is;~        -  to compare the phenotypes of coagulation, the tumor progression and metastasis formation~          with and without clopidogrel treatment in association with chemotherapy in advanced~          pancreatic cancer patients~        -  to correlate the decrease of microparticles levels after one month of chemotherapy with~          tumor response (ancillary study)~   "
88895|NCT02403544|"~     This is a phase I study to evaluate the safety of concurrent chemoradiation combining~     radiotherapy (IGRT) with two cytotoxic agents, capecitabine and oxaliplatin in patients with~     advanced or inoperable hepatocellular carcinoma.~   "
91473|NCT02369874|"~     This is a randomized, open-label, multi-center, global, Phase III study to determine the~     efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy~     versus SoC therapy in the target patient population.~   "
88821|NCT02404506|"~     Breast cancer is the most frequent malignancy in women, world-wide the leading cause of~     cancer mortality. One of the strongest risk factors for developing breast cancer is age, with~     a prevalence approaching 7% in women >70 years; more than 40% of breast cancer patients are~     older than 65 years. Although the survival rate has increased in the last years, about one~     third of patients will relapse with distant metastases. Treatment for patients with~     metastatic breast cancer is palliative, therefore maintaining or improving quality of life.~      The use of taxanes and anthracyclines as first line chemotherapy regimen for metastatic~     breast cancer is widely accepted. Both taxanes and anthracyclines have considerable side~     effects, especially in elderly patients.~      Eribulin, a synthetic analogue of a chemotherapeutically active compound derived from the sea~     sponge Halichondria okadai, acts as an inhibitor of microtubule dynamics. It is registered as~     palliative chemotherapy in advanced breast cancer after anthracyclines and taxanes. Studies~     with eribulin treatment have shown similar efficacy compared to anthracyclines and taxanes,~     but less toxicity. Those studies showed that often the dose of eribulin had to be reduced~     during treatment due to toxicity without compromising the efficacy of the treatment.~      The main objective of the trial is to explore the efficacy of a reduced starting dose of~     eribulin as first-line treatment in elderly metastatic breast cancer patients. The secondary~     objective of the trial is to investigate the safety of eribulin in those patients.~      Eribulin mesilate 1.1mg/m2 i.v. will be administered intravenously every 3 weeks on day 1 and~     day 8 until progressive disease.~   "
88822|NCT02404493|"~     The purpose of this 3 week study is to test the effectiveness of an over-the-counter (OTC)~     skin balm in infants and toddlers with mild to moderate dry, itchy skin.~   "
88823|NCT02404480|"~     This is a Phase 1, open-label, first-in-human, safety and pharmacokinetic study of PTC596 in~     patients with advanced cancer.~   "
88824|NCT02404467|"~     The hypothesis behind this study is that there is a proportion of patients considered high or~     intermediate risk for surgery, but relatively low risk for TAVI, which can be discharged~     early after the procedure (within the first 2-3 days) without additional risks. Therefore,~     when performed in safety, an early discharge may cut periprocedural TAVI costs significantly.~   "
88825|NCT02404454|"~     The septate uterus is the most common structural uterine anomaly. It results from failure of~     the partition between the two fused Müllerian ducts to resorb;it is associated with the~     highest incidence of reproductive failure and with first- and second-trimester pregnancy loss~     and infertility.~      Hysteroscopic division of the uterine septum is performed using microscissors,~     electrosurgery, or laser. Several studies shown significant improvement in pregnancy outcome~     after hysteroscopic metroplasty.~      Purpose of this study is to verify the effectiveness of 5 ml, instead of 10 ml, of~     autocross-linked hyaluronic acid gel in the prevention of the formation of intrauterine~     adhesions, through second look office hysteroscopy after three months.~   "
88826|NCT02404441|"~     The purpose of this first-in-human study of PDR001 is to characterize the safety,~     tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of PDR001~     administered i.v. as a single agent to adult patients with solid tumors.~      By blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2, PDR001 inhibits~     the PD-1 immune checkpoint, resulting in activation of an antitumor immune response by~     activating effector T-cells and inhibiting regulatory T-cells.~      This study has been designed as a phase I/II, multi-center, open-label study starting with a~     phase I dose escalation part followed by a phase II part.~      PDR001 will be administered every 2 weeks until patient experiences unacceptable toxicity,~     progressive disease per immune related Response Criteria (irRC) and/or treatment is~     discontinued at the discretion of the investigator or the patient.~   "
88827|NCT02404428|"~     Prostate cancer is a major public health problem and there is a strong need of new preventive~     strategies based on drug and lifestyle interventions. It is now well-established that healthy~     eating patterns and increasing physical activity can prevent or delay prostate cancer~     progression. Intake of cruciferous vegetables (e.g. broccoli, cabbage, cauliflower, Brussels~     sprouts, kale) has been associated with decreased risk of prostate cancer progression;~     however the underlying biological mechanisms remain unknown. The investigators propose to~     undertake a pilot study on a group of men with early prostate cancer on active surveillance~     to determine whether a diet rich in broccoli will induce changes in tumor size and blood flow~     measured by conventional Magnetic Resonance Imaging (MRI) techniques. Men with early prostate~     cancer on active surveillance who have visible cancer lesions on MRI will be recruited onto~     this double-blinded randomized intervention and they will be asked to eat one portion of~     broccoli soup per week for 6 months. The investigators will test two varieties of broccoli~     (standard and 'Beneforte extra' broccoli) that are able to deliver two different levels of~     sulforaphane (SF), an active compound extensively studied for its potential anticancer~     properties. This study will involve MRI scans, blood and urine collection before and after a~     6 month intervention period. This study design will not only allow us to observe diet-induced~     changes within the prostate but also at the systemic level. In addition, participant's~     lifestyle (habitual diet and physical activity) will be assessed by food diaries and exercise~     questionnaires.~      This study has been funded by Biotechnology and Biological Sciences Research Council (BBSRC)~     and Prostate Cancer foundation (PCF).~   "
88828|NCT02404415|"~     The Vanderbilt Atrial Fibrillation Ablation registry (VAFAR) is a prospective clinical and~     genetic biorepository that systematically enrolls patients undergoing atrial fibrillation~     (AF) ablation. The registry was started in 2011 and has greater than 1000 AF ablation records~     with stored blood and DNA samples. The goals of VAFAR are to: 1) identify clinical, genetic,~     and serological predictors of response to AF ablation in order to improve patient selection,~     and 2) to provide a resource for translational research investigating the electrophysiologic~     mechanisms of AF pathogenesis.~   "
88829|NCT02404402|"~     This study investigates the efficacy of a novel neuromodulation treatment, light emitting~     diodes (LED), on cognition, neuropsychiatric status and quality of life in individuals with~     traumatic brain injury (TBI).~   "
88830|NCT02404389|"~     This is a randomized, vehicle controlled, active comparator, parallel group, study with a~     total duration of 24 weeks including screening and follow-up. Study drug is applied topically~     for 2 cycles of 4 week treatment, separated by 4 weeks off-treatment. Assessors of study~     endpoints are blinded to treatment allocation.~   "
88833|NCT02404350|"~     The purpose of this study is to demonstrate efficacy including effect on inhibition of~     progression of structural damage, safety and tolerability up to 2 years with primary focus at~     Week 16 (week 24 for structural damage), to support the use of secukinumab pre-filled syringe~     (PFS) by subcutaneous (s.c.) self-administration with or without loading regimen in subjects~     with active Psoriatic Arthritis (PsA) despite current or previous NSAID, DMARD therapy and/or~     previous anti-TNFα therapy. Long term efficacy up to 2 years will be based on signs and~     symptoms of joint/bone structure preservation (X-ray) and improvement in physical function~     measured by Health Assessment Questionnaire - Disability Index (HAQ-DI©), as well as skin and~     nail improvement for psoriasis signs.~   "
88834|NCT02404337|"~     Oral treatment with betaine is conventionally used for patients with inherited~     homocystinurias.~      These conditions include a first group of patients with a cystathionine β-synthase (CBS)~     deficiency and a second group of patients with remethylation defects.~      The aim of betaine therapy is to reduce level of total plasma homocysteine. Daily dosages and~     rhythm of administration proposed in the literature vary between 100 to 250 mg / kg / d in 2~     to 4 doses. These dosages are not based on validated data and several publications mention~     much higher dosages particularly when total homocysteine is not controlled. These practices~     may be unnecessary or even detrimental given the fact that high doses of betaine could for~     example lead to secondary folate deficiency.~   "
88835|NCT02404324|"~     The objective of this prospective study is the treatment of esotropia by prescribing the full~     precise optical correction of refractive errors in children up to 3 years old.~   "
88836|NCT02404311|"~     The HIV Vaccine Trials Network (HVTN) is doing a study to test a new HIV vaccine combination.~     HIV is the virus that causes AIDS.~      About 252 people will take part in this study at multiple sites. The US National Institutes~     of Health (NIH) is paying for the study.~      The investigators are doing this study to answer several questions.~        -  Are the study vaccines safe to give to people?~        -  Are people able to take the study vaccines without becoming too uncomfortable?~        -  How do people's immune systems respond to the study vaccines? (Your immune system~          protects you from disease.)~   "
88837|NCT02404298|"~     Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is an immune-mediated~     disorder of peripheral nerves. Intravenous immunoglobulins (IVIg) are a first line therapy~     for CIDP. The investigators used a transcriptomic approach to compare the gene expression~     profiles in the peripheral blood of patients having a CIDP or autoimmune diseases, before and~     after IVIg treatment, in order to identify their mechanism of action in this condition, to~     lead to a better understanding of CIDP pathophysiology, and potentially determine factors~     associated with the response to the treatment.~   "
88838|NCT02404285|"~     This is a 12 week, multi-site, double-blind, vehicle-controlled study in subjects with mild~     to moderate facial acne. Subjects will be randomized 1:1 to apply either topical NAG or~     vehicle gel daily. Subjects will be evaluated for clinical acne and quality of life outcomes~     at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks.~   "
88839|NCT02404272|"~     Poor oral motor development in preterm neonates is common. Feeding problems lead to longer~     hospital stay and higher hospital cost. Different interventions have shown their efficacy to~     accelerate transition and move faster to full oral feeding autonomy. Our study aimed to~     evaluate the impact of a 2-year education nurse program on feeding pattern and hospital stay~     of preterm neonates.~      This is an interrupted time series study placed in Intensive Care and Neonatal unit of an~     university hospital located in Lyon, France. All preterm neonates are included in the study,~     from April 2013 to January 2016.~   "
88840|NCT02404259|"~     This study will assess the pharmacokinetics of TDF in Thai HIV-infected children~   "
88841|NCT02404246|"~     This pilot effectiveness trial will evaluate the feasibility, acceptability, and~     effectiveness of a structured peer support program based on the Certified Peer Specialist~     Program of the Depression and Bipolar Support Alliance (DBSA).~   "
88842|NCT02404233|"~     Current HIV treatment guidelines recommend the use of triple-drug therapy (two nucleoside~     reverse transcriptase inhibitors and either a protease inhibitor, non-nucleoside reverse~     transcriptase inhibitor, or an integrase inhibitor) for the treatment of antiretroviral~     (ARV)-naïve patients. With the introduction of highly active antiretroviral therapy (HAART),~     patients with HIV are living much longer. With the increasing lifespan of persons with HIV,~     long-term complications from therapy as well as the occurrence of co-morbidities with aging~     have prompted HCPs to re-think the current treatment paradigm and consider novel combinations~     of ARVs. All of the currently approved HIV antiretrovirals have been implicated in causing~     long-term toxicities; however the greatest body of evidence for long-term metabolic effects~     has implicated the nucleoside reverse transcriptase (NRTI) class. By utilizing a non-NRTI~     treatment regimen, it is hypothesized that many of these long-term metabolic effects (renal~     toxicity, bone loss, body fat changes) can be delayed or avoided altogether. The clinical~     data on novel combinations is currently limited but rapidly growing and has included several~     combinations that have utilized darunavir. This study will be the first of its kind using the~     unique combination of darunavir/cobicistat and rilpivirine. Currently, this drug combination~     is not a recommended option for first time treatment of HIV~   "
88843|NCT02404220|"~     This study will evaluate the safety, efficacy, tolerability, and pharmacokinetics of~     entospletinib (GS-9973) in combination with vincristine (VCR), and dexamethasone in adults~     with previously treated relapsed or refractory B-cell lineage acute lymphoblastic leukemia~     (ALL).~      This is a dose escalation study in which after 2 induction cycles participants may be put on~     maintenance for up to 36 cycles if they have obtained clinical benefit from the treatment.~   "
88844|NCT02404207|"~     The study will determine the effects of different types of soybean oils on biomarkers of risk~     for cardiovascular disease and diabetes. There will be four 4-week diet periods in which~     participants will consume the following oils, within the context of a controlled diet:~     soybean oil, high-oleic soybean oil, blend of high oleic soybean oil & fully hydrogenated~     soybean oil, and blend of palm olein & palm stearin.~   "
88852|NCT02404103|"~     The purpose of this study is to see how two doses of Flunisolide HFA (an FDA approved inhaled~     medication to treat asthma) affect the small airways in children with asthma.~   "
88853|NCT02404090|"~     Evaluation of the subchondral mineralization plate after excess weight loss in patientes~     undergoing bariatric operation by means of CT-osteoabsorptiometry.~   "
88845|NCT02404194|"~     This project is a randomized-controlled trial to test the efficacy of computer-based targeted~     cognitive training (TCT) versus a placebo intervention of commercial computer games in~     adolescent/young adults at clinical high risk (CHR) for psychosis. TCT is designed to~     optimize learning-induced neuroplasticity in vulnerable neurocognitive systems. A main aim is~     to test the hypothesis that this neuroscience-guided TCT intervention will improve neural~     function, and that these neural improvements will improve cognition and functional outcome.~     CHR participants will be randomly assigned to 40 hours of TCT or placebo computer games~     completed within 10 weeks. TCT consists of 20 hours of training in cognition, including~     processing speed, memory, attention, and cognitive control followed by 20 hours of training~     in social cognition including affect recognition and theory of mind. Neuroimaging, cognition,~     social cognition, clinical symptoms, and functional status will be assessed at baseline,~     after 20 hours/5 weeks of cognitive training (mid-intervention), and after 20 hours/5 weeks~     of social-cognitive training (post-intervention). Cognition, social cognition, symptoms, and~     functioning will also be assessed at a 9 month follow-up (i.e. 9 months after intervention~     completion). We predict that TCT will lead to improvements in neurocognitive function and~     functional status. The results of this study will provide important information about a~     benign, non-pharmacological intervention for improving cognition and functional outcome in~     CHR individuals.~   "
88846|NCT02404181|"~     Delirium is a common disorder in hospitalized patients, nevertheless it is poorly recognized~     by physicians and nurses, even when screening instruments are used. Electroencephalography~     (EEG) appears to be a sensitive tool for the diagnosis of delirium. However, standard EEG~     recording with 25 electrodes is labor intensive. We have previously showed that a brief EEG~     registration with three electrodes and automatic processing can distinguish patients with~     delirium from patients without delirium very well. However, these findings need to be~     validated in an unselected population.~      The primary objective of this validation study is to investigate the sensitivity,~     specificity, and predictive values of the EEG-based delirium monitor (including three~     electrodes and a reference electrode) compared to delirium quantification in frail elderly~     patients after surgery.~      In an international multicenter study, 154 frail elderly patients will be included who will~     undergo elective surgery and are expected to remain admitted for at least two postoperative~     days. Patients are excluded if communication is not possible or admitted for neurological~     surgery.~      A five minute EEG registration with the delirium monitor with four electrodes will be~     performed prior surgery and three consecutive days after surgery or until discharge. Within~     one hour of the EEG recording, the delirium assessment will be performed and recorded on~     video, which will be evaluated by delirium experts. The relative delta power (calculated from~     one minute of artifact-free EEG segment) will be compared with the conclusion of the delirium~     experts.~   "
88847|NCT02404168|"~     The prior BEEP study involved patients being switched between brand and generic in a very~     structured manner. Other secondary comparisons were also made (i.e. any differences in~     adverse effects and seizure control). Some subjects were more disparate than other, in terms~     of generic being similar to brand. In this follow up study, BEEP subjects that showed~     disparate results will be tested again to assess reproducibility of disparate results.~   "
88848|NCT02404155|"~     Clozapine (CLZ) is the most effective antipsychotic for treatment-refractory schizophrenia~     (SZ). Despite the overwhelming evidence of superior efficacy, CLZ is infrequently prescribed~     in the US, at a considerably lower rate than the estimated prevalence of treatment-resistant~     SZ, especially for African-Americans (AA). Recent evidence suggests that low Absolute~     Neutrophil Counts (ANC), either at baseline or during treatment are a significant barrier to~     CLZ use in AA patients in the US, where guidelines mandate CLZ discontinuation if ANC drops~     below 1500 cells/mm3. The investigators group has found that discontinuation of CLZ in AA~     patients is over twice that in European-American (EA) patients (N~400; 42% vs.19%, P=0.041)~     and initiation rates are 50% lower. In a Statewide study (N=1875), the investigators reported~     that discontinuation was more frequently due to neutropenia in the AA sample, though no AA~     had developed agranulocytosis (8 cases in EA). Benign Ethnic Neutropenia (BEN) in people of~     African ancestry, including AAs, identifies a group (50% of AA) with low ANCs but no~     increased risk of agranulocytosis or infection. Low baseline or in-treatment fluctuations~     requiring CLZ discontinuation under current prescribing guidelines are common in CLZ-treated~     persons with BEN. In the investigators recent pilot study of N=12 AA patients with BEN,~     treatment was safely and successfully continued with CLZ despite low baseline ANC (outside~     current guidelines). Recent evidence implicates a polymorphism in the Duffy Antigen Receptor~     Chemokine (DARC) gene in the pathophysiology of BEN. In homozygotes (FY-/-) for the DARC null~     allele, mean within-subject neutrophil counts are reduced, resulting in sporadic ANC <1500~     cells/mm3 in 10-15% of people with the allele. In population studies, the FY-/- genotype is~     found in 0.01% of EAs, 99.3% of sub-Saharan Africans (SSA), and 68% of AAs. Further, a~     missense DARC mutation has been reported to interact with the DARC FY-/- in determining low~     WBC in AAs. Normal patterns of week-to-week fluctuation in ANC levels in individuals of~     African ancestry with BEN and the DARC null genotype are not known, and no published research~     has examined variation in ANC in African ancestry CLZ-treated SZ patients with BEN and the~     DARC null genotype (FY-/-). Such data are also lacking on individuals with BEN without the~     DARC null genotype. Conducting such research will generate genetic marker and safety data~     that could be used to expand access to CLZ for AA patients who otherwise are eligible to~     receive this superior treatment option.~   "
88849|NCT02404142|"~     In this prospective, randomized study, the investigators assess the intubation conditions~     during videolaryngoscopy with Glidescope Titanium whether patients receive (curare~     (Atracurium) group) or no (control group) within elective surgery patients with no difficult~     intubation prediction~   "
88850|NCT02404129|"~     As the geriatric population continues to rise, the consequences of falls and fall-related~     injuries carry increasing socioeconomic significance. Fall during turning is 7.9 times more~     likely to result in hip fracture than a fall while walking straight. Hence, turning carries a~     significant risk for hip fracture. Turning is ubiquitous during activities of daily living,~     yet most gait research has focused on straight ahead walking.~      Turning affects lower limb kinematics, kinetics, and step parameters. Therefore it appears to~     be a greater challenge for individuals with mobility problems. Turning ability is affected by~     age changes and balance confidence. TURN180 test was built to assess the parameters of~     turning. It has four major categories which are the most readily identified indictors of~     difficulty in turning while walking. These categories are: (1) the type of turn (or strategy)~     used to accomplish the turn, (2) the number of steps taken during the turn, (3) the time~     taken to accomplish the turn, and (4) staggering during the turn.~      The purpose of this study is to explore the TURN180 test ability to evaluate the risk of~     falling in the elderly population and compare it to the known gold standard clinical test.~     This is a validation study of balance and mobility tests using a three-group sample of~     convenience. The independent elderly subjects (n=75) will be divided into three groups~     according to their falls history and undergo four balance tests: Timed Up and Go test~     (TUG), Tinetti Balance Test (Tinetti), Berg Balance Scale (BBS). The participants will be~     videotaped while performing the TUG test. Basic temporospatial aspects of turning during~     walking such as the number of steps taken during the turn and the time taken to accomplish~     the turn will be measured using both the slow-motion and stop-action capabilities of the VCR~     system and a time-code processor.~   "
88851|NCT02404116|"~     The study involves a comparing a new psychological treatment- Metacognitive Therapy (MCT)~     which has shown promising results in the treatment of health anxiety to no treatment at all-~     a waiting list.~   "
88854|NCT02404077|"~     The investigators' clinical practice makes use of oral clonidine as a means of transitioning~     from intravenous dexmedetomidine following prolonged infusions (more than 3-5 days). Although~     this is common clinical practice, there is limited clinical data to demonstrate the efficacy~     of this technique and to provide clonidine dosing guidelines. The purpose of this study is to~     retrospectively review the investigators' experience with the use of oral clonidine to~     prevent withdrawal following the prolonged administration of dexmedetomidine.~   "
88855|NCT02404064|"~     To compare surgical site infection (SSI) rate in patients undergoing laparoscopic~     appendectomy for acute uncomplicated appendicitis and treated with single dose regime of~     antibiotics versus group of patients undergoing laparoscopic appendectomy without antibiotics~     treatment. Patient will be given either single dose of perioperative antibiotics or no~     antibiotics before surgery.~   "
88856|NCT02404051|"~     This is a multi-center, randomized, open-label, parallel group study designed to evaluate~     efficacy and safety of fulvestrant followed, at progression, by examestane and everolimus~     versus examestane and everolimus followed, at progression, by fulvestrant in postmenopausal~     women with HR+ and HER2- LABC or MBC whose disease has progressed to NSAI in the adjuvant or~     metastatic setting.~   "
88857|NCT02404038|"~     This study will enrol sexually active, healthy girls aged 16-17 to assess and compare the~     acceptability and preference for a monthly vaginal ring, bi-monthly injectable contraception~     or daily dose oral contraception, as proxy for female-controlled ARV-based HIV prevention~     methods.~   "
88858|NCT02404025|"~     This is an open label, non-randomized, phase II study of eltrombopag in combination with~     rabbit ATG/CsA in subjects with moderate or more severe AA who have not received prior~     ATG/ALG-based immunosuppressive therapy. The objective is to assess additive effects of~     eltorombopag on overall response rate (ORR) at 6 months (Week 26) of treatment with ATG/CsA.~     Subjects will be assessed at least weekly for safety during the period from the start of~     ATG/CsA to 4 weeks after the start of administration of eltrombopag. After that, subjects~     will visit every 2 weeks until Week 26. Subjects in whom the treatment is assessed as~     effective at Week 26 may continue treatment with eltrombopag after 6 months when clinically~     indicated at the discretion of the investigator. There are five follow-up visits: at~     discontinuation of the treatment of eltrombopag, and Weeks 1, 2, 3, 4 and 26 after treatment~     discontinuation. As this study is the first Japanese phase II study in which this product is~     administered in combination with ATG/CsA to subjects with naive moderate or more severe AA,~     the subject number of this study is determined to be 10 based on the feasibility survey.~   "
88859|NCT02404012|"~     There is a high prevalence of iron deficiency in patients who undergo bariatric surgery and~     effective therapies are lacking. Thus, there is a critical need for an effective,~     non-invasive, and inexpensive form of iron supplementation to treat iron deficiency and~     improve tolerance, the associated cognitive symptoms, and quality of life in the bariatric~     surgery patient population. Often, patients do not participate in bariatric programs, are not~     compliant, and/or are lost to follow-up. If there is a more effective and evidence-based~     guideline for repletion of iron deficiency, patients are more likely to be compliant.~     Therefore, in a randomized controlled study, the investigators propose to test the~     effectiveness of various iron formulations versus ferrous sulfate, which is the standard of~     care, for oral iron supplementation of iron deficient patients who have had RYGB or SG~     bariatric surgery. By randomizing patients into the two groups, the investigators will be~     able to determine the most effective regimen to improve blood biomarkers of iron status,~     cognitive function, and quality of life. Other outcomes will include adverse effects and~     compliance to the supplementation. The investigators will also analyze three-day food records~     to determine the contribution of dietary factors to changes in iron status. To test for~     improvement of iron status, serial blood draws will be performed during a time period of ~10~     weeks. Serial blood draws from iron deficient patients have routinely been performed in past~     studies and have not been found to be harmful. Because this is a relatively short study (10~     weeks), subjects will be able to recover quickly from the blood loss during the study. The~     investigators expect to find that iron supplementation with organic formulations of iron will~     be as effective than ferrous sulfate for repletion of iron deficiency, and they will be~     better tolerated. This project will address a significant health issue in individuals who~     have had bariatric surgery, which is a growing population in the United States. It is~     estimated that almost 1.5 million individuals have undergone bariatric surgery since the year~     1990.~   "
88860|NCT02403999|"~     This will be a single centre, evaluator blind, randomized, parallel group, stratified, two~     week study in healthy participants. The clinical study is designed to provide reassurance~     that the formulations developed for children and babies with mild to moderately dry skin and~     for children whose skin is prone to atopic dermatitis (eczema) are well tolerated in the~     target population, babies and young children with dry skin.~   "
88861|NCT02403986|"~     A randomised, multi-centre, parallel-group efficacy and safety study evaluating two and three~     initial treatment sessions of Restylane Skinboosters Vital Lidocaine in the face.~      Approximately 50 female subjects shall be treated with two or three initial treatment~     sessions including long-term follow-up 18 months after the initial treatment regimen.~   "
88862|NCT02403973|"~     To explore the possible benefit of a patient hotel, a study was undertaken to test the~     hypothesis that perioperative care at a patient hotel would be valued better than care in a~     general ward. The study focuses solely on the patients' perspective and satisfaction of the~     care provided.~   "
88863|NCT02403960|"~     Aim: to evaluate the additional effects of the 12 weeks usage of a Streptococcus containing~     probiotic tablet after scaling and rootplaning compared to a placebo tablet.~      Materials and methods: 48 periodontitis patients were included in this double-blind,~     placebo-controlled trial. After scaling and rootplaning, they were given patients used either~     a placebo (SRP) or probiotic tablet (SRP + P), 2 times a day for 12 weeks. Clinical and~     microbiological parameters were studied recorded up to 24 weeks after scaling and~     rootplaning.~   "
88864|NCT02403947|"~     Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system~     (CNS), which ultimately leads to myelin damage and axonal loss. The disease is complex and~     multifactorial, but the key pathogenic event appears to be an uncontrolled response of~     components of the immune system (T and B lymphocytes) to myelin proteins. No definitive~     treatment is available for MS, however immunomodulatory and immunosuppressant drugs act as~     disease-modifying agents (DMDs).~      Unfortunately, the current treatments demonstrate partial efficacy in targeting the~     deleterious immune reactions. According to the present knowledge of the pathophysiology of~     MS, an ideal therapeutic strategy would be to modulate or suppress the aggressive immune~     process, to protect axons and neurons from degeneration, and to enhance repair and facilitate~     remyelination.~      A specific form of stem cells, called adult mesenchymal stem cells (MSCs), has shown~     remarkable ability to modulate the immune response. This study will evaluate the safety of~     injecting MSCs in people with MS.~   "
88890|NCT02403609|"~     The purpose of this study is to evaluate test-retest reliability of each subtest (correlation~     coefficients for Time 1 and 2) in the Brain Performance Test (BPT, Lumos Labs, Inc.).~   "
88865|NCT02403934|"~     Maintaining a patent airway is a constant concern to any anesthesia provider performing deep~     sedation cases. The doses of sedative medications often required for the desired level of~     sedation in a patient often result in occlusion of the airway and the patient becoming~     apneic. Opening the collapsed or occluded airway requires the use of an invasive airway~     device, (e.g. laryngeal mask airway (LMA), oral airway or nasal airway) or the application of~     a jaw thrust maneuver. When the provider provides jaw thrust while attending to the other~     duties, the patient may not have adequate ventilation and the patient's oxygen saturation can~     fall producing hypoxemia. Airway management devices currently available require deeper levels~     of sedation to be tolerated by patients. In order to avoid the need for internal airway~     devices, providers attempt to carefully adjust the level of sedation so that no airway~     support is required. For safety, providers usually try to stay on the light side of the~     sedation scale. Unfortunately, this often results in an uncomfortable patient or one who is~     moving too much to successfully carry out the procedure. Until the availability of the Jaw~     Elevation Device (JED) there was no external device providers could utilize to assist in~     opening a patient's airway. By duplicating the jaw thrust maneuver, the JED maintains a~     patent airway. Once applied, it frees the anesthesia provider to attend to other duties~     associated with administration of anesthesia without requiring the provider to manually~     maintain a jaw thrust maneuver. The advantages with such a device would allow a level of~     sedation deep enough for the patient to tolerate the procedure as well as maintain a patent~     airway. To date, there have not been any studies evaluating the JED in clinical practice. The~     investigators wish to evaluate the JED in a standardized fashion during deep sedation or~     monitored anesthesia care (MAC). Our study would involve 50 patients who became apneic during~     deep sedation or MAC. A jaw thrust maneuver will be initially performed to demonstrate that~     each patient's airway can be adequately supported by this maneuver. The JED will then be~     placed in order to maintain a patent airway, while leaving the level of sedation unchanged.~     Intraoperative monitoring, continuous ECG, pulse oximetry, blood pressure, capnography, will~     be routine, and determined by the anesthesia team. The investigators will also track how~     often the provider was required to adjust the JED to maintain a patent airway, and if the~     need to convert to an alternate method of airway management was required. The investigators~     will pursue publication of the results as the first study demonstrating the efficacy of the~     JED.~   "
88866|NCT02403921|"~     The investigators aim to investigate the association between hair, serum, urine and saliva to~     measure cortisol, cortisone, cotinine, nicotine, melatonin and caffeine.~   "
88867|NCT02403908|"~     The aim of research proposal is to assess and compare the safety and efficacy of~     radiofrequency denervation of pulmonary arteries on decrease in pulmonary vascular resistance~     and mean pulmonary artery pressure (MPAP) in 20 patients with IPAH (mean pulmonary artery~     pressure >25 mmHg) and in 20 patients with secondary pulmonary hypertension due to pulmonary~     disease or due to left heart disease not responding optimally to medical therapy.~   "
88868|NCT02403895|"~     Open--label, phase 2a, multi-centre, single-arm study to assess the efficacy and safety of~     AZD2014 and weekly paclitaxel in patients with squamous non-small cell lung cancer (NSCLC)~   "
88869|NCT02403882|"~     The investigators run a series of behavioral economic interventions at client-choice food~     pantries to encourage clients to choose targeted foods.~   "
88870|NCT02403869|"~     Post-authorization, prospective follow-up, multi-centre, national study to estimate~     definitive deterioration in the quality of life in patients with metastatic breast cancer~     treated with second-line monochemotherapy.~   "
88871|NCT02403856|"~     Calcific tendinitis of the rotator cuff is a common cause of chronic pain of the shoulder.~     Needling and lavage of the calcification is one of the therapeutic options after failure of~     conservative management with physiotherapy and anti-inflammatory drugs. Needling is usually~     followed by a corticosteroid injection in the subacromial bursae in order to prevent acute~     pain reaction due to the intervention. However, the relevance of this injection has never~     been proven. Moreover, corticosteroid could prevent the inflammatory reaction induced by the~     needling and thus the body's natural calcium resorption processes. Finally, corticosteroids~     could have deleterious effect on the tendon structures and favour local infection. Our~     hypothesis is that corticosteroid have no significant effect on acute pain after needling and~     therefore should not been performed systematically after needling.~   "
88872|NCT02403843|"~     The purpose of the study is to follow patients with partial onset seizures prospectively over~     5 years in the real-world environment to gather data on the long-term safety and~     effectiveness of the RNS System at qualified CECs by qualified neurologists, epileptologists,~     and neurosurgeons trained on the RNS System.~   "
88873|NCT02403830|"~     Ticagrelor is associated with more prompt and potent antiplatelet effects compared with~     clopidogrel, leading to better clinical outcomes, including reduced cardiovascular mortality,~     across the spectrum of patients with acute coronary syndrome, including those with~     ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary~     intervention (PCI). However, in this latter setting a delay in the onset of its antiplatelet~     effects has been shown. Morphine has been identified as a cause of delayed P2Y12 inhibition~     in patients with STEMI. Methylnaltrexone is a parenteral peripheral opioid receptor~     antagonist which has the potential to prevent or reverse opioid-induced peripherally mediated~     side effects without affecting analgesia. However, whether the use of intravenous~     methylnaltrexone may overcome the effects of morphine administration on the pharmacokinetic~     (PK) and pharmacodynamics (PD) profiles of ticagrelor has not been investigated yet. The~     proposed investigation will include patients with coronary artery disease and will have a~     prospective, randomized, cross-over design.~   "
88874|NCT02403817|"~     Current therapies for autism target social and language behaviors, but due to the high-level~     nature of these skills any improvement rarely extends beyond the targeted behavior. This~     project uses new technology to implement a novel concept for behavioral intervention to~     improve basic attention and eye movement skills in ASD. Because these basic skills form the~     foundation for good social communication, training these abilities has the potential to~     improve a broad spectrum of clinical symptoms, and in young children may affect the course of~     development.~   "
88875|NCT02403804|"~     The goal is to assess whether, in adult women during the luteal phase of their menstrual~     cycle, supplementing their diet with either phosphatidylcholine or betaine increases their~     serum choline levels.~   "
88876|NCT02403791|"~     The purpose of this study was to evaluate the availability and diagnostic accuracy of~     point-of-care bedside lung ultrasound examination in management of mechanical ventilation in~     neonatal acute respiratory distress syndrome.~   "
88877|NCT02403778|"~     The purpose of this study is to assess the safety and efficacy of combined treatment with~     Ipilimumab and all-trans retinoic acid (ATRA) in melanoma patients.~   "
88878|NCT02403765|"~     The study aims to identify genetic variants associated to Parkinson's disease through the~     analysis of exome-sequencing data of familial cases and controls. The identified variants~     will be used to generate a diagnostic tool for the identification of genetic risk profiles.~   "
88891|NCT02403596|"~     This study evaluates the efficacy of tranexamic acid versus placebo on perioperative blood~     loss using two dosage regimens (standard and extended) after a surgery during total hip~     arthroplasty in patients receiving the novel fast-acting oral anticoagulant rivaroxaban for~     prophylaxis of thrombosis.~   "
88879|NCT02403752|"~     Specific Aim 1: To determine feasibility of a 20-minute dyadic exercise program for~     ambulatory individuals with dementia and caregivers living at home based on recruitment,~     adherence and retention. Investigators will conduct a pilot randomized controlled trial (RCT)~     with 20 dyads (total N = 40) in groups of 5 randomized to 16-week group exercise classes and~     regular home practice or wait list in a cross-over design. Investigators will assess~     feasibility of enrollment and retention, the proportion of completed outcome measures, and~     adherence by class attendance logs, caregiver-reported home practice logs and qualitative~     interviews to assess ease of implementation in the home environment. Investigators will~     explore feasibility of weekly phone calls to (potentially overwhelmed) caregivers and Fit-bit~     accelerometers as a measure for tracking home practice.~      Specific Aim 2: To collect preliminary effect size data for sample size calculation for a~     larger trial. Investigators will assess standard outcomes (such as the Short Physical~     Performance Battery and Alzheimer's Disease Assessment Scale - cognitive subscale as primary~     outcomes for affected individuals; and Caregiver Burden Inventory for caregivers) commonly~     used in pharmacological studies of individuals with dementia at baseline, 16 and 32 weeks and~     calculate effect sizes (Cohen's d) for between-group differences in outcome changes in the 20~     dyads of the RCT described in Specific Aim 1.~      Specific Aim 3: To explore the feasibility of using non-invasive Near-Infrared Spectroscopy~     (NIRS) to assess regional cortical brain oxygenation and its sensitivity to change.~     Investigators will compare brain oxygenation variations before and after the exercise~     intervention during a memory task for the seniors with dementia.~   "
88880|NCT02403739|"~     Simulated growth data will be shown to clinicians in two formats - (1) as weight vs.age~     charts, (2) as weight Z-score vs. age charts. Clinicians will be asked to identify whether~     growth is too fast, too slow, or normal. The test will take a total of 10 minutes.~   "
88881|NCT02403726|"~     The purposes of this study were to analyse demographic, medical, gender and socio-economic~     aspects of osteoporosis associated vertebral fractures.~   "
88882|NCT02403713|"~     A 2-group healthy volunteer study to compare a breath actuated inhaler (BAI) and a~     pressurised metered dose inhaler (pMDI) with and without spacer.~   "
88883|NCT02403700|"~     Bone modeling after tooth extraction has a major consequence on implant therapy, in~     particular in the esthetic zone. In esthetic sites, no tissue loss should occur if an optimal~     esthetic outcome is expected. Recent experimental studies in dogs have shown that neither an~     immediate implant insertion nor ridge preservation techniques can prevent this bone modeling~     process.~   "
88884|NCT02403687|"~     A 24-week observational prospective study on the efficacy of topical non-steroidal~     anti-inflammatory drugs for the relief of pain.~   "
88885|NCT02403674|"~     The purpose of this study is to compare the antiretroviral activity of MK-1439A, a~     single-tablet, once-daily (q.d.) fixed-dose combination (FDC) containing doravirine (MK-1439)~     100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, with ATRIPLA™, a~     single-tablet FDC containing efavirenz 600 mg + emtricitabine 200 mg + tenofovir disoproxil~     fumarate 300 mg, in treatment-naive participants infected with human immunodeficiency virus~     (HIV). The primary hypothesis is that MK-1439A q.d. is non-inferior to ATRIPLA™ q.d. as~     assessed by the proportion of participants with HIV-1 ribonucleic acid (RNA) <50 copies/mL~     (by the Abbott RealTime HIV-1 Assay) at Week 48.~   "
88886|NCT02403661|"~     The primary goal of this study is to quantify the functional deficits caused by injuries to~     the brachial plexus and peripheral nerve in the arm. The second goal is to test the possible~     benefit of electrical stimulation of the injured nerve following surgery. The investigators~     will test whether electrical stimulation will improve hand function and nerve regeneration~     after repair for nerve injury. Injuries causing nerve damage in the arm and hand are common.~     In severe cases, functional outcomes even with surgery remain poor. Recently, electrical~     stimulation has been applied to injured nerves in rats. This was shown to improve nerve~     regeneration. These studies showed that as little as one hour of electrical stimulation was~     effective. Therefore, the investigators plan to test this new method of treatment to~     determine whether it is also helpful in humans. These will be done by using a symptom~     severity questionnaire, nerve conduction studies and by testing pressure sensations, hand~     dexterity and strength. The patients will be randomized to either the treatment or control~     group. Following the treatment, all baseline measurements will be reevaluated every three~     months for the first year and every 6 months during the second year. The timing and nature of~     the evaluation process will be identical in both groups.~   "
88887|NCT02403648|"~     BIOD-961 is a dry powder formulation of glucagon intended for use in a device that mixes~     (reconstitutes) the powder with liquid to make it easier for users to treat patients with~     severe hypoglycemia. The purpose of this study is to evaluate how much BIOD-961 absorbs into~     the bloodstream, how much it raises glucose concentrations (the intended effect) and compare~     to two glucagon products already on the market.~   "
88888|NCT02403635|"~     CYP3A4 is involved in the metabolism of many drugs. So, it is important to assess in vivo the~     induction effect of ASP2151 on that enzyme to determine the extent of any possible drug~     interactions. The aim of this trial is to investigate the potential for interaction of~     ASP2151 with the CYP3A4 probe substrate midazolam.~   "
88889|NCT02403622|"~     The overarching objective of this study is to address the knowledge gap regarding the~     short-term and long-term safety of fecal microbiota transplants (FMT). The design will be a~     prospective, open-label, multi-center longitudinal cohort study to assess the short- and~     long-term safety of FMT as well as the clinical resolution of diarrhea among 150 patients~     with 3 or more episodes of clostridium difficile infection (CDI defined as 3 unformed stools~     over 24 hours for 2 consecutive days and either a positive stool test for CDI or~     pseudomembranes on colonoscopy/sigmoidoscopy). Subjects will be adult outpatients referred to~     one of the study centers after at least three recurrent episodes of CDI and previous~     treatment with at least one 10-day course of oral vancomycin or fidaxomicin. After FMT by~     colonoscopy/sigmoidoscopy or enema, patients will be followed prospectively and monitored for~     clinical resolution and adverse events at: 3 days (telephone), 3 weeks (clinical assessment),~     8 weeks (telephone), 6 months (telephone), and 12 months (telephone) after FMT. Subjects who~     recur will be offered a second FMT by colonoscopy with a different donor. Microbiome analysis~     will be conducted from stool samples at baseline and each of the 5 follow-up intervals.~   "
88896|NCT02403531|"~     The contribution of induction chemotherapy before definitive chemoradiotherapy is unknown.~     The purpose of this study was to compare the efficacy and toxicity of induction chemotherapy~     followed by definitive chemoradiotherapy versus no induction chemotherapy in patients with~     inoperable thoracic esophageal squamous cell carcinoma.~   "
88897|NCT02403518|"~     This study evaluates the Freedom SCS (spinal cord stimulation) System for the treatment of~     chronic back and leg pain. Patients who have been diagnosed with failed back surgery syndrome~     (FBSS) will receive a stimulator device for treatment of their pain.~   "
88898|NCT02403505|"~     That current oncology drugs on USA market have the universal problems about low effectiveness~     of pharmacology to cancer cells and high risk of toxicology to normal cells can demonstrate~     following most significantly and most reasonably: it is not enough so far away that just only~     oncology drug target molecules as cancer patient-specific biomarkers directly; it must be~     that oncology drug targets' SNPs like as real personalized or individualized cancer~     patient-specific biomarkers.~   "
88899|NCT02403492|"~     Heart disease is a major cause of ill-health and death in adults. The risk factors for heart~     disease, if present in children, carry over into adult life. Childhood obesity has reached~     epidemic proportions in Canada and is associated with many heart disease risk factors such as~     high blood pressure. Another complication of obesity is obstructive sleep apnea. Sleep apnea~     is marked by snoring at night, pauses in breathing and low oxygen levels and occurs in up to~     60% of obese children, but it is diagnosed in less than 20% of obese children. Importantly,~     sleep apnea in children, like obesity, is linked with high blood pressure and heart disease.~     Thus, children with sleep apnea who are obese are likely to have an increased risk for high~     blood pressure and heart disease. Currently, there is little knowledge of the extent of heart~     disease in obese children with sleep apnea.~      The best treatment for both obesity and sleep apnea is weight loss. Weight loss strategies~     are generally not very successful and since 75% of obese children will become obese adults,~     urgent treatments are needed to reduce heart disease in the long-term. Treating sleep apnea~     in obese children may be one of the ways to reduce heart disease. Sleep apnea can be treated~     with continuous positive airway pressure (CPAP), which involves wearing a mask attached to a~     breathing machine while asleep. It is unknown how effective CPAP is in reducing heart disease~     in obese children.~      The investigators will recruit children with sleep apnea who are obese and test for heart~     disease risk. The investigators will then treat these children with CPAP. After 6 months of~     CPAP, the investigators will repeat the tests to determine if CPAP lowers the risk for heart~     disease. At the end of the 6 months, those receiving CPAP will be randomized to either~     continue CPAP or discontinue CPAP for a 2 week period. At the end of the 2 week period the~     participants will repeat the tests again to determine the magnitude of the effect of CPAP.~      The investigators expect that CPAP treatment for sleep apnea in obese children will reduce~     blood pressure and lower heart disease. These results will increase awareness of the dangers~     of sleep apnea in obese children, which will facilitate early diagnosis and treatment,~     ultimately reducing heart disease long-term.~   "
88900|NCT02403479|"~     Chronic rhinosinusitis without polyposis (CRSsP) is a very common condition that occurs when~     the lining of the sinuses becomes persistently irritated. Standard management options include~     topical steroids, antibiotics and surgery, but treatment-resistant CRSsP is frequently~     encountered. Bacterial biofilms are routinely detected within the nasal mucosa of CRSsP~     patients and are now thought to play an important role in the protracted nature of the~     disease. Colloidal silver is a widely used naturopathic agent that has recently been shown to~     eliminate bacteria, and in particular in vitro sinusitis biofilms, in laboratory studies.~     Although silver is currently used in a variety of chronic wound therapies, it has not yet~     been formally studied in people with CRSsP. It is our intention with this project to~     determine whether colloidal silver is a useful treatment strategy for patients with~     refractory CRS.~   "
88901|NCT02403466|"~     Because communication and handoff failures are a root cause of two-thirds of sentinel~     events- serious, often fatal preventable adverse events in hospitals improving handoffs has~     been identified by AHRQ and the Joint Commission as a priority in nationwide efforts to~     improve patient safety. Comparative Effectiveness Research on handoff tools and processes has~     identified specific strategies to improve handoffs and reduce medical errors: 1) team~     training; 2) verbal mnemonics; and 3) use of written/computerized tools to supplement verbal~     sign-outs. To accelerate residents' use of CER-based handoff practices and improve patient~     safety, the investigators are implementing the three inventions above as a Resident Handoff~     Bundle (RHB) in eight pediatric hospitals in the United States and Canada.~   "
88902|NCT02403453|"~     A Prospective, open label, multi-center observational study of patients requiring surgical~     treatment at one or two (contiguous) cervical spine levels. The primary objectives of the~     RHINE Cervical Disc study are to: obtain operative data and feedback on surgical instruments~     and surgical technique; confirm device performance in terms of clinical and radiographic~     outcomes; confirm device performance in terms of safety and to collect original data to be~     compared to published reports of the performance of comparable motion-sparing devices, as~     well as clinical outcomes of fusion devices.~   "
88903|NCT02403440|"~     The purpose of this study is to obtain information on efficacy, safety and Pharmacokinetics~     (PK)/Pharmacodynamics (PD) of Hetrombopag over 14 days in Chinese patients with chronic ITP.~   "
88904|NCT02403427|"~     The purpose of this study to conduct the preliminary investigation on the efficacy and safety~     in terms of postprandial glucose value and the rates of hypoglycaemia when expert VoiceDiab~     system supports patient's decision on prandial insulin programming in insulin pump therapy.~   "
88905|NCT02403414|"~     Acromegaly is associated with increased risk of difficult intubation and its management. The~     overall incidence of difficult intubation in patients suffering from acromegaly is four to~     five times more than those without acromegaly.The difficult intubation scenario in these~     patients can be managed by various methods ranging from awake fiberoptic intubation to~     tracheostomy. Difficult tracheal intubation accounts for 17% of respiratory-related injuries~     and results in significant morbidity and mortality in general population. In patients with~     acromegaly, inability to mask ventilate or intubate can lead to 28% of all anesthesia related~     deaths. Therefore, the need and importance of airway assessment in patients with acromegaly~     cannot be overemphasized. Various tests of airway assessment have to be used to assess~     difficult airway and tracheal intubation in acromegalics.~      The investigators aim to assess the various tests of airway assessment affecting the outcome~     of patients with acromegaly undergoing pituitary surgery and identify which was best suited.~   "
88906|NCT02403401|"~     Purpose of the study is to investigate safety and contraceptive efficacy of an LNG-containing~     intravaginal ring.~   "
88907|NCT02403388|"~     Avoidable care associated incidents are relatively frequent in primary care. In France for~     example, avoidable incidents rate is estimated to 22/1000 medical acts from general~     practitioners. Patient safety is now a growing issue in primary care. One tool to increase~     patient safety is incident reporting and analysis. It could reduce some important~     consequences for patients and could allow implementing substantial corrective actions.~      The aim of the PRisM study is to assess and compare the efficiency of a multifaceted risk~     management program implemented in the french pluridisciplinary offices in primary care in~     association with a centralized incident reporting system, versus a centralized incident~     reporting system only.~   "
88908|NCT02403375|"~     This study is to compare metabolic control, treatment satisfaction, and quality of life~     during continuous subcutaneous insulin infusion (CSII ) therapy with a new insulin pump~     system with multiple daily injections (MDI) therapy. Furthermore, this study will add~     clinical data originating from clinical investigation in a special population, i.e. children~     and adolescents of ages 2 - 17 years , to the existing clinical data of the ACCU-CHEK Insight~     insulin pump.~   "
88909|NCT02403362|"~     The purpose of this study is to evaluate the safety,efficacy， pharmacodynamics (PD), and~     pharmacokinetics (PK) of multiple intravenous doses of EPO-018B in participants with chronic~     kidney disease (CKD) Who are not on dialysis~   "
88910|NCT02403349|"~     Confirm central blood pressure reduction effect of Fimasartan, Valsartan and Atenolol and~     compare correlation with the measured peripheral (central blood pressure, pulse wave~     velocity, and flow-mediated dilation) and cerebral blood flow factors (transcranial doppler~     findings, cerebral blood flow volume) in acute ischemic stroke patients with hypertension.~   "
88911|NCT02403336|"~     Objective: To evaluate the efficiency of a group intervention opposite to the usual care to~     improve the quality of life, measured with the SF-12 questionnaire, in women between 45-55~     years to the primary health care centres.~   "
88912|NCT02403323|"~     This two-part, open-label extension and safety monitoring study will examine the safety and~     efficacy of continued etrolizumab treatment in patients with moderate to severely active~     Crohn's disease who were previously enrolled in the etrolizumab Phase III Study GA29144.~   "
88913|NCT02403310|"~     The main purpose of this study is to determine the safety of combining selinexor with~     daunorubicin and cytarabine. The maximal tolerated dose (MTD) of selinexor with daunorubicin~     and cytarabine will also be established.~   "
88914|NCT02403297|"~     The purpose of this study is to learn if a chair-side testing device will accurately measure~     levels of a salivary biomarker and thus indicate if a patient has periodontal health,~     gingivitis or periodontal disease.~   "
88915|NCT02403284|"~     In this research study, investigators will test the effects of an approved medication for~     diabetes,Liraglutide, to reduce insulin resistance that develops from eating a diet high in~     saturated fats.~   "
88916|NCT02403271|"~     This is a Phase 1b/2, multi-center study to assess the safety and efficacy of ibrutinib in~     combination with durvalumab (MEDI4736) in subjects with relapsed or refractory solid tumors.~   "
88917|NCT02403258|"~     To evaluate the effect and safety of plum-blossom needle for Tourette syndrome.~   "
88918|NCT02403245|"~     The aim of this study is to evaluate the direct impact of one session of social stimulation~     on social interactions of people with moderate dementia living in nursing home in comparison~     of one session without direct social stimulation.~   "
88919|NCT02403232|"~     Crohn's disease is an immunologically mediated inflammatory bowel disease with a reported~     incidence of 4.0-7.0, 7.1, and 1.34 per 100,000 persons in Europe, the U.S., and Korea,~     respectively. Uncontrolled chronic inflammation finally causes various complications in~     intestine such as bowel obstruction, fistulas, abscesses, and anal fissures.~      The incidence of perianal fistula was reported in 13%- 39% of patients with Crohn's disease.~     Medical treatment for Crohn's fistulae initially focused on surgical intervention accompanied~     by symptomatic treatment with antibiotics and immunosuppressants. The most serious problem~     after surgical intervention is the relatively high incidence of postoperative anal~     incontinence caused by sphincter injury during the procedure. Conversely, available~     pharmacological therapies for Crohn's fistulae based on biologic agents such as infliximab do~     not generally reach ideal goal of treatment (e.g., complete closure of the fistula). A high~     recurrence rate after treatment with infliximab has also been reported, even after long-term~     maintenance therapy, which suggests that infliximab monotherapy does not provide adequate~     healing.~      The ACCENT II study demonstraded a complete fistula healing in 25% of patients. To reach a~     better clinical outcome, combination treatment with infliximab and surgical intervention is~     highly recommended for management of Crohn's fistulae. Nonetheless, even this strategy does~     not result in a satisfactory healing for many patients.~      The ideal therapeutic goal of treatment is not only complete closure of the fistula without~     recurrence but also preservation of anal sphincter function. Unfortunately, currently~     available medical or surgical treatment is not likely to offer a cure for perianal fistulae~     and, as noted above, recurrence is frequently reported.~      Together with active research in the field of bone marrow-derived mesenchymal stem cells~     (BM-MSCs) and hematopoietic stem cells, autologous or allogenic adipose tissue-derived stem~     cells (ASCs) have been studied for management of Crohn's disease and other disorders.~      Of particular relevance to this study, ASCs could be considered to be safe and efficacious~     therapeutic tools for the treatment of Crohn's fistulae. Importantly, ASCs do not cause fecal~     incontinence after injection into the lesion site in Crohn's disease patients. A phase I~     dose-escalation clinical study with ASCs manufactured by Anterogen Co., Ltd. (Seoul, Korea)~     demonstrated the safety and therapeutic potential of these cells for the treatment of Crohn's~     fistulae. A phase II study demonstrated a good rate of cronh's related fistula closure using~     a ASCS injection.~      Actually the best accepted treatment of Crohn related perianal fistula, is the surgical~     procedure in association whit medical therapy.~   "
88920|NCT02403219|"~     This is a prospective, comparative, contralateral eye study. Patients older than 18 years who~     have had treatment with topical lubricants for at least 1 month and persist with symptoms of~     dry eye and corneal staining with fluorescein were included. Patients with dry eye~     attributable to abnormalities of the eyelids, nasolacrimal obstruction and active corneal~     infection, as well as patients with severe dry eye were excluded from the study. One eye~     randomly received a subcutaneous injection of botulinum toxin in the medial part of the lower~     eyelid, and the other eye received a similar procedure with placebo. The subjective~     evaluation was achieved with a questionnaire assessing symptoms of dry eye and~     conjunctivitis, quality of vision and ocular comfort level each eye separately. The objective~     evaluation included the measurement of the tear film break up time, Schirmer's test and with~     a modification of the Oxford grading scheme for corneal and conjunctival staining.~   "
88921|NCT02403206|"~     The purpose of the study is to compare femtosecond laser-assisted capsulotomy to manual~     capsulorhexis in patients with intumescent cataracts. An intumescent cataract is defined as a~     cataract with a pressurized capsular bag.~   "
88922|NCT02403193|"~     The purpose of this study is to determine the safety, tolerability, feasibility and~     preliminary efficacy of the administration of PBF-509 (Adenosine A2a receptor antagonist) as~     single agent or in combination with PDR001 (programmed cell death 1 receptor antibody (PD-1~     Ab)) to NSCLC patients.~   "
88923|NCT02403180|"~     The purpose of this study is to evaluate the visual performance of DACP MF and PROCLEAR 1D MF~     daily disposable contact lenses in an established presbyopic population.~   "
88933|NCT02403037|"~     To evaluate the feasibility of a three-parallel-arm, placebo-controlled randomized trial~     using a standard auricular acupressure protocol for managing nausea and vomiting in a~     homogenous group of female breast cancer patients undergoing chemotherapy.~      The null hypotheses of this study are: (1) There will be no significant difference in~     acute/delayed nausea and vomiting among groups during the intervention period; (2) There will~     be no significant difference in anticipatory nausea and vomiting among groups before the~     second cycle of chemotherapy; (3) There will be no significant difference in quality of life~     status among groups at the end of the first cycle of chemotherapy.~   "
88924|NCT02403154|"~     The purpose of this research is to compare patient outcomes of two treatment methods that are~     currently used as standard of care to treat anterior pelvic ring injuries that require~     stabilization. The two treatment methods are subcutaneous internal fixation (INFIX) and~     external fixation (EXFIX). Patients will be given the opportunity to opt out of randomization~     and participate in one of the observational arms. The first observational arm is comprised of~     those patients who do not want to randomize and they will undergo anterior pelvic ring~     stabilization according to the treating surgeon's discretion. The second observational arm~     will be comprised of patients who consent to be in the study but whose pelvic ring fractures~     do not require any form of anterior pelvic internal fixation based on the treating surgeon's~     opinion.~   "
88925|NCT02403141|"~     Obstructive sleep apnoea (OSA) is a common medical problem which, despite increasing~     awareness, remains under-diagnosed. There is a close association between OSA and obesity;~     60-70% of patients diagnosed with OSA are either obese or overweight [1]. OSA is also very~     common among patients with type 2 diabetes. Type 2 Diabetes Mellitus (T2DM) has reached~     epidemic status in the Gulf region. OSA worsens insulin resistance and leads to weight gain~     through sleep disturbance [2]. Several mechanisms have been proposed for the associations of~     OSA with diabetes and obesity [3]. At present there is little available information regarding~     the prevalence of OSA in the UAE, the relationship with T2DM and obesity, and the impact of~     OSA on health outcomes in the Emirati population. This research will explore these~     relationships and inform public health decisions regarding diagnostic pathways, service~     provision and treatment protocols.~   "
88926|NCT02403128|"~     Phase 1, non-randomized, open label, noncomparative trial to study the effect of intravitreal~     injection of aflibercept on eyes with symptomatic macular edema from retinal artery~     macroaneurysms.~   "
88927|NCT02403115|"~     The purpose of this study is to clarify the mechanisms involved in the formation and~     glomerular deposition of immune complexes in lupus nephritis.~      The determination of an antibody pattern specific for systemic lupus erythematosus and lupus~     nephritis may also have a role in predicting disease progression in patients with systemic~     lupus erythematosus without renal impairment. As for the patients enrolled in the study, the~     determination of their antibody patterns may contribute to a more targeted and personalized~     treatment, allowing a prediction of disease progression and the introduction of early~     targeted treatments, in order to block the onset and/or progression of renal damage.~   "
88928|NCT02403102|"~     Theranostics is the use of a diagnostic test to decide which patients will benefit from a~     certain treatment.~      The current standard treatment for patients with myeloma is induction chemotherapy followed~     by peripheral stem cell transplant. Although there are options for timing of treatments,~     patient outcomes are variable and the investigators do not currently know which patients~     benefit from which treatment schedule. There is evidence to suggest that residual disease on~     imaging after treatment is an indicator for a worse prognosis, however the best time point~     for this imaging is currently not known. This study is designed to show if there is an~     optimum time point for correlation between imaging and prognosis.~      Several studies have indicated that MRI is better at detecting disease than FDG PET/CT and~     the investigators will confirm this when patients are first diagnosed, by performing both FDG~     PET/CT and whole body diffusion weighted MRI.~      Patients will then be followed up with whole body diffusion weighted MRI after induction~     chemotherapy and 3 months post autograft. The investigators will look at the amount of~     disease present on these scans and correlate this with outcomes.~      There are likely to be other factors which influence patient outcomes (such as genetics) and~     the investigators will also look at some of these. Patients who undergo autograft have~     regular blood tests and marrow samples taken as part of routine care, the investigators will~     use some of these samples (without compromising the patients treatment) to analyses some of~     these other factors. If the investigators are able to determine a correlation of genetic~     factors with outcome this information could be used in future research.~      Theranostics is the use of a diagnostic test to decide which patients will benefit from a~     certain treatment.~      The current standard treatment for patients with myeloma is induction chemotherapy followed~     by peripheral stem cell transplant. Although there are options for timing of treatments,~     patient outcomes are variable and the investigators do not currently know which patients~     benefit from which treatment schedule. There is evidence to suggest that residual disease on~     imaging after treatment is an indicator for a worse prognosis, however the best time point~     for this imaging is currently not known. This study is designed to show if there is an~     optimum time point for correlation between imaging and prognosis.~      Several studies have indicated that MRI is better at detecting disease than FDG PET/CT and~     the investigators will confirm this when patients are first diagnosed, by performing both FDG~     PET/CT and whole body diffusion weighted MRI.~      Patients will then be followed up with whole body diffusion weighted MRI after induction~     chemotherapy and 3 months post autograft. The investigators will look at the amount of~     disease present on these scans and correlate this with outcomes.~      There are likely to be other factors which influence patient outcomes (such as genetics) and~     the investigators will also look at some of these. Patients who undergo autograft have~     regular blood tests and marrow samples taken as part of routine care, the investigators will~     use some of these samples (without compromising the patients treatment) to analyses some of~     these other factors. If the investigators are able to determine a correlation of genetic~     factors with outcome this information could be used in future research.~   "
88929|NCT02403089|"~     The objective of this study is 1/ to determine the rate and kinetics of MAIT cell expansion~     and maturation in neonates in relation with gestational age, and in HSCT recipient children~     in relation with the source of donor stem cells, 2/ to correlate gut microbiota diversity and~     function with MAIT cell maturation and function in neonates and HSCT recipients; and 3/ to~     link MAIT cells and gut microbiota composition with microbial infections and severe~     intestinal inflammatory events in term and preterm neonates, and in HSCT recipients~   "
88930|NCT02403076|"~     Unlike the management of patients with various forms of accidents (e.g. polytrauma), only a~     few data exists for the emergency management of patients with acute gastrointestinal~     bleeding. The aim of our study is to develop optimal diagnostic and therapeutic algorithms~     for the management of acute upper and lower gastrointestinal bleedings.~   "
88931|NCT02403063|"~     It was recently shown that neostigmine reversal was associated with increased atelectasis and~     that high-dose neostigmine was associated with longer postoperative length of stay and with~     an increased incidence of pulmonary edema and reintubation. These study results were~     consistent with findings from a previous epidemiological study which revealed an absence of~     beneficial effects of neostigmine on postoperative oxygenation and reintubation. In our~     previous study, the effects of neostigmine / glycopyrrolate and sugammadex on the~     electromyographic activity of the diaphragm showed beneficial effects for sugammadex. This~     could be explained by a possible effect on neuromuscular transmission at the muscle level,~     but can also be explained by a neostigmine-induced decrease in total nerve activity. In a~     study in cats, neostigmine has been shown to reduce efferent phrenic nerve activity. The~     investigators aim to show a difference in phrenic nerve activity between neostigmine and~     sugammadex, administered alone or in combination, in healthy male volunteers.~   "
88932|NCT02403050|"~     Currently, patients of suitable fitness with non-metastatic esophageal cancer are treated~     with surgery, radiotherapy or chemoradiotherapy. If treated with radio or chemoradiotherapy,~     a Computerised tomography (CT) scan is performed and is the dataset used for planning~     radiotherapy. Information from the endoscopic ultrasound (EUS), performed during routine~     staging, is used to help localize the tumor, as tumors of the esophagus are poorly visualised~     on CT. This information is subjective and dependant on the clinician performing the~     procedure. The tumor is described in relation to common anatomical landmarks. Interpretion of~     this information can lead to over-compensation when attempting to cover the tumor with a~     radiation field, to avoid a miss. It is thought that using fiducial markers called~     Visicoils placed in or adjacent to the tumor's top and bottom extent at the time of EUS, will~     lead to better definition of the tumor in the planning process and hence, improvement in~     local tumor control, and reduction in radiotherapy dose to normal tissue.~   "
88982|NCT02402374|"~     Autologous platelet-rich plasma (PRP) gel was reported to have very good outcomes in the~     treatment of foot ulcers in pilot studies and retrospective uncontrolled trials. Therefore, a~     larger randomized, placebo-controlled clinical trial will be useful to determine whether~     platelet-rich plasma is safe and effective for the treatment of diabetic foot ulcers (DFU).~   "
88934|NCT02403024|"~     Background: The level physical exercise is strongly associated with colorectal cancer risk in~     the general population, and recent data shows that physical activity after a colorectal~     cancer diagnosis is inversely associated with mortality risk, indication the physical~     exercise can protect against disease progression. However, few studies have successfully~     performed exercise interventions in patients with colorectal cancer, and the potential~     mechanisms responsible for the tumor suppressing effects of exercise remain poorly explored.~      Purpose: To investigate interval-walking, delivered by the InterWalk smart phone application~     as exercise-modality in patients with colorectal cancer. Specifically it is the aim to~     explore if InterWalk is safe and feasible as well as effective to improve cardio-metabolic~     health profile.~      Subjects: Colorectal cancer patients, stage I-III, who are at least one month post-surgery~     and have concluded any adjuvant chemotherapy treatment, are eligible for inclusion. Exclusion~     criteria are: age <18; any major surgical procedure planned within 6 months after inclusion;~     pregnancy; ongoing treatment for any known malignancy; performance status > 1; unable to read~     and understand Danish~      Methods: 40 colorectal cancer patients are included and randomized to I) InterWalk or II)~     waiting list control for 24 weeks. Patients are evaluated at baseline, week 12 and week 24 by~     assessment measures to determine cardio-metabolic health profile and other relevant study~     outcomes, including: cardiopulmonary exercise test (VO2peak); anthropometrics; blood~     pressure; resting heart rate; body composition; health related quality of life~     questionnaires; plasma concentration levels of cholesterol, triglycerides, insulin, glucose~     and inflammatory cytokines; insulin sensitivity; and cognitive function.~   "
88935|NCT02403011|"~     This study investigates the effect of soft tissue mobilization in babies with neck muscle~     problem. Babies received soft tissue mobilization or home exercises program~   "
88936|NCT02402998|"~     A clinical study to evaluate the efficacy of a drug called eltrombopag in adult patients~     affected of primary immune thrombocytopenia as first treatment to address the disease.~   "
88937|NCT02402985|"~     This 6-week parallel randomised prospective dietary intervention study with type 2 Diabetes~     investigates the nutrition influence of animal protein in comparison to plant protein on the~     glucose metabolism.~   "
88938|NCT02402972|"~     To investigate whether intraoperative intraportal chemotherapy combined with adjuvant~     chemotherapy as treatment could improve disease-free survival (DFS) in patients with curative~     colorectal cancer resection compared with adjuvant chemotherapy alone.~      This is a prospective, blind (doctors who done outcome measures were masked), multi-center,~     2-arm randomized controlled trial.~   "
88939|NCT02402959|"~     The primary purpose of this study is to discover, establish and refine the individual~     treatment protocol of each TCM expert for insomnia, and to explore what characteristics of~     the patients are considered with the corresponding treatment in clinical practices.~      The secondary purpose is to determine the effectiveness of TCM pattern differentiation~     treatment for the patients with insomnia.~   "
88940|NCT02402946|"~     Rumination syndrome is characterized by effortless recurrent regurgitation of recently~     ingested food into the mouth, with consequent expulsión or re-chewing and swallowing. In a~     previous study we showed that rumination is produced by an unperceived, somatic response to~     food ingestión. After having identified the key mechanisms of rumination, we developed an~     original EMG guided biofeedback technique with specific targets for correction, based on~     EMG-guided control of abdomino-thoracic muscular activity, and in a pilot study we showed the~     potential effectivity of this treatment. In a subsequent study this technique was validated~     by a formal placebo-controlled, randomized trial. The current aim is to test the efficacy of~     a simplified biofeedback technique not requiring EMG-guided control.~   "
88941|NCT02402933|"~     Up to fifty (50) children and adolescents with type 1 diabetes (T1D) aged 4 to ˂18 years at~     time of enrolment will be selected for inclusion in the study. The target is to obtain~     treatment response and user-experience data following use of AMG504-1 (LY900018) in treating~     episodes of hypoglycemia.~   "
88942|NCT02402920|"~     The goal of this clinical research study is to find the highest tolerable dose of~     pembrolizumab (also called MK-3475) and radiation therapy (either with chemotherapy or alone)~     that can be given to patients with SCLC.~      This is an investigational study. Radiation therapy is delivered using FDA-approved and~     commercially available methods for local control of metastatic and primary tumors.~     Pembrolizumab is FDA approved and commercially available for the treatment of unresectable or~     metastatic melanoma. It use in this study is investigational.~      Up to 80 patients will take part in this study. All will be enrolled at MD Anderson.~   "
88943|NCT02402907|"~     The objective of this study is to determine if the use of chlorhexidine gluconate cloths~     prior to cesarean section reduce the rate of infectious morbidity (i.e. surgical site~     infections, endometritis).~      The study will be offered to women who present for a scheduled primary or repeat cesarean~     section at Mount Sinai Medical Center. The eligible women will be randomized to use of a 2%~     chlorhexidine gluconate (CHG) cloth or placebo cloth (a fragrance free cleansing cloth) the~     night before and the morning of their scheduled procedure. Participants will be blinded to~     the arm in which they have been assigned. This study intends to show that the use of 2% CHG~     cloths prior to cesarean section will reduce the rate of surgical site infections.~   "
88944|NCT02402894|"~     The purpose of the study is to study how a person-centered structured team caretaking of~     young adults (16-23 years) with newly diagnosed rheumatoid arthritis (RA), spondartrit (SpA)~     and psoriasartrit (PsA) in routine clinical care affect and predict the patient's health and~     ability to manage their everyday lives. Also included in the project is a long-term follow-up~     (up to 50 years) where the investigators want to investigate factors predicting good general~     health, low disease activity, good physical function, and comorbidity.~   "
88945|NCT02402881|"~     The investigators have recently developed a registry of missed doses of VTE prophylaxis that~     includes retrospective data on missed doses of VTE prophylaxis. To decrease rates of VTE~     prophylaxis refusal, the group has developed a patient-centered education bundle that will be~     delivered as an in-person, 1-on-1 discussion session with a nurse educator. Supporting~     education materials include a 2-page education sheet and an educational video.~      The investigators hypothesize that patient refusal of VTE prophylaxis is associated with~     significant knowledge gaps among patients regarding their risk of developing VTE and the~     benefits of VTE prophylaxis and that delivering an education bundle to patients that refuse~     VTE prophylaxis will improve compliance with VTE prophylaxis and decrease rates of VTE.~   "
88946|NCT02402868|"~     This study will examine the effectiveness of intranasal (IN) ketamine compared to standard~     intravenous (IV) ketamine administration for simple reductions of orthopaedic injuries in the~     paediatric population. The aim is to assess if IN administration is equivalent to the current~     standard of care, IV. The population to be studied is children 5-17 years of age who require~     a simple orthopaedic reduction. Following a double dummy approach to overcome the difficulty~     in masking interventions, each participant will recieve both IV and IN interventions, only~     one of which will be the real drug. Procedural conscious sedation (PCS) will be assessed~     using the University of Michigan Sedation Scale (UMSS).~   "
88947|NCT02402855|"~     This study aims to evaluate the impact of financial support on improving the management of~     prenatal care in pregnant women with low incomes. The judgment criterion is clinically~     pertinent: complications of pregnancy. This study also aims to evaluate attitudes to this~     approach through a qualitative survey.~      It is planned to include 4000 women distributed into two arms of 2000 each. One group will~     receive financial support (prepaid payment card credited for each consultation attended~     according to the scheduled follow-up as recommended by the Haute Autorité de Santé); the~     other group will not. The management of the pregnancy for both groups will not be modified.~   "
88948|NCT02402842|"~     Squamous cell carcinoma of the anal canal (SCCA) is a rare disease and mostly diagnosed at an~     early stage. After standard concurrent chemoradiation (CRT) with mitomycin (MMC) and~     5-fluorouracil (5FU), the disease will recur in 20% of patients. After treatment failure~     (including salvage surgery), cisplatin-5FU combination is the standard option but complete~     response is a rare event and the prognosis remains poor with most patients' death occurring~     in the first 12 months. Decision making for physicians in this setting is only based on~     retrospective studies or small phase II clinical trials including less than 20 patients.~     Hence, no efficient standard of care is currently available for relapsing SCCA patients who~     are currently treated with a palliative intent.~      Between 2007 and 2013, 8 consecutive patients with advanced recurrent SCCA after CRT were~     treated with DCF regimen (docetaxel, cisplatin and 5-fluorouracil) in the Regional Cancer~     Institute of Franche Comté. After a median follow-up of 41 months, 4 patients (50%) achieved~     a complete response. Three patients underwent surgery of all involved metastatic sites. A~     pathological complete response was observed for all of them including in metastases occurring~     in irradiated fields, suggesting that taxane-based chemotherapy might be an effective~     strategy to circumvent resistance to radiotherapy (a preliminary cohort of 8 patients was~     published (Kim S et al Annals of oncology 2013). Furthermore, all complete responders were~     HPV 16, and high levels of specific T cell responses against Human Papillomavirus (HPV)~     HPV16-derived E6/E7 and telomerase were detected in 50% of complete responders suggesting the~     potential restoration of cancer immunosurveillance by this regimen.~      Then, the Epitopes-HPV02 multicenter phase II study will aim to confirm the new role of~     taxane-based chemotherapy in SCCA patients.~   "
88949|NCT02402829|"~     The purpose of this research study is to see if factor levels and inhibitor levels in~     Hemophilia A and B subjects are accurate when they are drawn from a central venous line (CVL)~     instead of from a peripheral stick.~   "
88950|NCT02402816|"~     The purpose of this study is to assess the impact of the Multi Point Pacing (MPP) feature in~     the treatment of patients with QRS beetwen 100 and 130 msec in patients candidate to ICD~     implant.~   "
88951|NCT02402803|"~     Cardiovascular disease (CVD) is the number one cause of mortality for men and women in the~     United States. Dyslipidemia, particularly a high low-density-lipoprotein cholesterol (LDL-C)~     level, is a well-established cardiovascular risk factor and the current American Heart~     Association guideline for CVD risk assessment recommends a lipid panel to be checked. In~     addition, guidelines recommend statin therapy in all patients with clinical atherosclerotic~     CVD, all patients with LDL-C = 190 mg/dL, patients age 40-75 years with diabetes and LDL-C~     70-189 mg/dL, and patients with an estimated 10-year atherosclerotic CVD risk = 7.5%. For all~     of these patients, a fasting lipid panel should be drawn prior to statin initiation as well~     as during follow-up to assess medication and lifestyle adherence. These fasting lipid panels~     are obtained via conventional phlebotomy via venopuncture in an office-based or hospital~     laboratory setting. However, research protein quantitation with mass spectrometry and~     enzyme-linked immunosorbent assay (ELISA) are technologies that allow for sensitive~     quantitation of protein biomarkers and targets, including lipoproteins. Most importantly,~     multiple reaction monitoring (MRM) mass spectrometry is able to assess samples from a dried~     blood spot (DBS), whose advantages include minimal volume requirements, ease of sample~     attainment by finger stick with minimal training required, ease of transport, and sample~     stability.~      The purpose of the proposed analysis is to 1) measure changes in CVD biomarkers before and~     after initiation of statin therapy and 2) compare lipid measurements by conventional~     phlebotomy blood samples to research protein quantitation measurements in DBS and plasma.~   "
88952|NCT02402764|"~     The main purpose of this study is to see whether the combination of selinexor (KPT-330) can~     help people with triple negative breast cancer (TNBC). Researchers also want to study the~     safety and tolerability of Selinexor in TNBC patients.~   "
88953|NCT02402751|"~     The Centre for Magnetic Resonance in Biology and Medicine (CRMBM, UMR-CNRS 7339 AMU) obtained~     funding for a whole body NMR imaging at 7. It is the only MRI at 7T installed in a hospital~     in France (only two 7T MRI in France) and therefore a unique opportunity to develop new~     diagnostic approaches.~      The purpose of this study is to develop, implement and validate new MRI quantitative~     parameters derived from ultra high field MRI in order to characterize non-invasively with an~     unprecedented resolution and sensitivity, anatomy as well as certain physiological,~     hemodynamic and metabolic function of brain, spinal cord, musculoskeletal system, and heart~     in healthy subjects~   "
88954|NCT02402738|"~     Bipolar disorder (BD) is a serious, disabling, and highly recurrent illness. The perinatal~     period dramatically increases risk for mood episodes in women with BD, but pregnancy~     complicates pharmacologic treatment decisions and efficacy. This study will be the first to~     systematically develop and pilot test an adjunctive psychosocial intervention to assist in~     treatment of BD during the high-risk perinatal period.~   "
88979|NCT02402413|"~     Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders occurring in~     women of reproductive age. PCOS is considered a syndrome of ovarian dysfunction that is~     characterized by the heterogeneous clinical manifestation of infrequent or absent menstrual~     cycles, hyperandrogenism, and polycystic ovarian morphology.~      An important ultrasound parameter is the ratio stroma/ovary, the ratio of the volume,~     evaluated in two-dimensional ultrasound, of the stroma, that secrete androgen, and the ovary.~     It has been shown that when this ratio is higher than a third the levels of circulating~     androgens and high. Aim of the present study is to assess whether this ratio, determined with~     three-dimensional ultrasound, is correlated to the increase of androgens.~   "
88983|NCT02402361|"~     Understanding risk factors and determinants for neuropathic pain.~   "
88955|NCT02402725|"~     This is a phase II, open label, single-center study of ultra-high dose dexamethasone~     administered intravenously and orally as monotherapy for the treatment of relapsed multiple~     myeloma. Dexamethasone has known anti-myeloma activity, and has been studied extensively both~     alone, and in combination with other agents, in the treatment of multiple myeloma.~      This study implements an optimal 2-stage design. In Stage 1, 10 patients will be enrolled.~     Each patient will receive 100mg of intravenous dexamethasone once on Day 1, immediately~     followed by 24mg of oral (PO) dexamethasone every 6 hours for 3 days (Days 1-3) in a 28-day~     cycle. After 4 cycles, the patients will be evaluated for efficacy and safety. If 2 or more~     of the original 10 patients experience a CR, very good partial response (VGPR), or PR, an~     additional 20 patients will be enrolled in Stage 2. The enrollment for Stage 2 will occur~     after the completion of 4 cycles of ultra-high dose dexamethasone. If <2 patients experience~     a CR, VGPR, or PR, the study will be discontinued. Patients will be treated until~     progression, intolerable side effects, or death.~      The purpose of the proposed phase II study is to determine the overall response rate,~     progression free survival, and tolerability of ultra-high dose dexamethasone.~   "
88956|NCT02402712|"~     This is an open-label, single-arm, multicenter, Phase IIIb study to evaluate the safety and~     tolerability of Herceptin SC in combination with Perjeta IV plus docetaxel in female patients~     with HER2-positive metastatic or locally recurrent breast cancer. Enrolled patients are to~     receive study medication until disease progression, unacceptable toxicity, withdrawal of~     consent, death, or predefined study end, whichever occurs first. The anticipated time on~     study treatment is approximately 24 months. The target sample size is 400.~   "
88957|NCT02402699|"~     This protocol is being conducted to comply with the direct request from the Taiwan Food and~     Drug Administration (TFDA) for a 60-month intensive pharmacovigilance protocol of patients~     with known hepatitis B (HBV) or hepatitis C (HCV) infection, regardless of control on~     antiviral therapy in Taiwan and who are treated with ipilimumab for advanced (unresectable,~     recurrent or metastatic) Melanoma.~   "
88958|NCT02402686|"~     The aim of this non-interventional study in Hungarian participants is to gather real life~     data about the efficacy and safety of tocilizumab SC monotherapy in RA, to assess data about~     pattern of usage of tocilizumab monotherapy in RA disease management.~   "
88959|NCT02402673|"~     Problem: Adolescent patellofemoral pain (PFP) is a major problem worldwide and affects 7% of~     adolescents. Adolescents with PFP have long-lasting severe pain and low quality of life.~     Current treatment is ineffective for more than 60% and new treatment approaches are needed.~      Solution: A novel multidimensional diagnostic approach combining imaging, physical activity~     level and pain sensitisation in adolescents with PFP. This approach will enable the~     identification of adolescents with PFP who benefits from a new treatment strategy using~     activity modification to reduce loading of the patellofemoral joint and graded exercises to~     improve loading capacity.~   "
88960|NCT02402660|"~     The purpose of this study is to determine the long term safety and tolerability of ALK-001~     (C20-D3-retinyl acetate), and to explore the effects of ALK-001 on the progression of~     Stargardt disease in patients between the ages of 12 and 60 years old.~      Funding Source - FDA OOPD~   "
88961|NCT02402647|"~     This project will utilize a novel behavioral intervention for hoarding disorder that takes~     into account age and neurocognitive factors. The goal of this project is to gain knowledge on~     how treatment components may or may not work for Veterans with hoarding disorder. Further,~     the investigators hope to increase understanding of functional and long term outcomes in~     response to hoarding treatment.~   "
88962|NCT02402634|"~     Mechanical ventilatory lung care is essential for postoperative care in liver transplantation~     recipients, for such patients are under massive fluid challenge and hemodynamic alterations~     perioperatively. Some of the recipients experience difficulty in weaning off from the~     mechanical ventilator due to various causes. This study is to investigate the relationship~     between the inflammatory gene polymorphism, known for acute lung injury, and the duration of~     mechanical ventilatory care for such liver transplantation recipients.~   "
88963|NCT02402621|"~     Comparing postoperative analgesics requirements and complications between conventional and~     model-based infusion strategy of intravenous patient-controlled analgesia in patients who~     undergoing robot assisted laparoscopic radical prostatectomy~      Group A: conventional intravenous patient-controlled analgesia, Group B: model-based infusion~     strategy of intravenous patient-controlled analgesia~   "
88964|NCT02402608|"~     This 3 months randomized, double-blind, placebo-controlled supplementation trial tested the~     hypothesis that nutritional supplementation with whey protein, essential amino acids and~     vitamin D concurrent with regular, controlled physical activity would increase muscle mass,~     strength, physical functional, quality of life, and decrease the risk of malnutrition and~     inflammation in sarcopenic elderly.~   "
88965|NCT02402595|"~     The purpose of this study is to determine the effects of a potent CYP3A4 inhibitor,~     itraconazole, on the steady-state PK of AVP-923 and AVP-786.~   "
88966|NCT02402582|"~     Implementing the Family-centered Empowerment Model (FCEM) as a new Cardiac Rehabilitation~     program for Myocardial Infarction patients with four-stage including perceived threat with~     group discussion method, self-efficacy with problem solving method, self-esteem with~     educational partnership and outcome and process evaluations~   "
88967|NCT02402569|"~     This study aims to demonstrate innocuity and feasibility of deep brain stimulation with a~     multi-electrodes set.~   "
88968|NCT02402556|"~     The purpose of the Mother Child Education Program (MOCEP)—a group-based early childhood~     development parenting education program—is to provide school-readiness and parenting skills~     to mothers of young children who do not have access to preschool education services. The~     MOCEP intervention also provides a setting in which caregivers can model pro-social behaviors~     and practice conflict resolution techniques directly with young children.~   "
88980|NCT02402400|"~     Our goal is to examine sub lingual versus traditional oral administration of ticagrelor in~     ACS/non ST-elevation Myocardial Infarction (NSTEMI) patients on platelet reactivity.~   "
88981|NCT02402387|"~     The purpose of this study is to investigate the changes of the oropharyngeal leak pressure of~     the air-Q self-pressurizing masked laryngeal airway in the different head and neck positions.~     Moreover, the adequacy of ventilation will be assessed in the different head and neck~     positions.~   "
88969|NCT02402543|"~     The perianal region is the region around the anus. Administering a pain medication before a~     surgery starts is called preemptive analgesia. In some studies, this technique has been shown~     to be an effective way to reduce the pain that a patient experiences in the post-operative~     timeframe to a greater extent than would be expected simply from the pain medications alone.~     One theory of why this occurs suggests that the preemptive analgesia desensitizes brain and~     nerves to pain, thereby decreasing the response to painful stimuli, like surgery when they~     occur. This leads to a decrease in the amount of narcotic pain medication required after the~     procedure, which leads to less side effects and a quicker return to normal functioning. As~     perianal surgeries do not usually include a long stay in the hospital, controlling~     post-procedure pain is a priority.~      The use of preemptive analgesia is in other types of surgeries, such as orthopedics, is well~     established, but as the perianal region has not been well studied, its use is not the~     standard of care. This type of analgesia uses a combination of medications that are already~     in use for post-operative and non-operative pain control and administers them orally prior to~     the patient undergoing general anesthesia. The side effects of the medications are the same~     as if they had been given after surgery or for non-surgical pain.~      The concept of preemptive analgesia is established in other types of surgeries and it has~     solid basic science to support its use. The purpose of this randomized, double-blind, placebo~     controlled study is to determine if patients undergoing perianal surgeries could benefit from~     preemptive pain control. The primary outcome will be whether patients experience less~     post-operative pain. Patient post-operative consumption and latency until use of narcotic~     pain medication will be the secondary outcomes. The investigators believe that the patients~     receiving pain medications before their operation will require less pain medication after~     surgery, with minimal increased risk to the patient.~   "
88970|NCT02402530|"~     This clinical trial is being conducted to demonstrate the efficacy of neridronic acid in the~     treatment of pain associated with complex regional pain syndrome type I (CRPS-I).~      The trial is divided into 3 periods: a 60-day enrollment period, a 12-week trial period, and~     an extended follow-up period with visits at Month 6, Month 9, and Month 12. The extended~     follow-up period will be terminated for all participants after the last participant enrolled~     completes their Month 6 visit (Visit 9). The double-blind will be maintained throughout the~     12-week trial period and extended follow-up period.~   "
88971|NCT02402517|"~     The objectives are to test the acute effects of different extruded pulse snacks on: 1)~     aerobic endurance and substrate oxidation during exercise 2) response of blood glucose,~     insulin and appetite on an aerobic exercise session, and 3) food intake two hours following~     the exercise session. The investigators hypothesize that consumption of food products~     containing pulse ingredients 60 minutes before exercise will increase aerobic endurance~     (lower oxygen consumption), decrease carbohydrate oxidation (greater respiratory quotient),~     and a reduction in lactate production during compared to the same exercise session following~     the ingestion of a non-pulse food. The investigators also hypothesize that consumption of~     extruded pulse snacks will lead to lower blood glucose, insulin, appetite and food intake,~     suggesting lower calorie compensation, following a 60-minute aerobic exercise session~     compared to the same exercise session following the ingestion of a non-pulse food.~   "
88972|NCT02402504|"~     The objectives are to test the acute effects of different extruded pulse snacks on: 1)~     post-prandial blood glucose, insulin and appetite for two hours, and 2) food intake two hours~     following consumption of pulse products.~      The investigators hypothesize that snack products containing pulse ingredients will lead to~     lower blood glucose, insulin, appetite and food intake responses compared to non-pulse snack~     products.~   "
88973|NCT02402491|"~     Patients undergoing the percutaneous coronary intervention (PCI) for in-stent restenosis~     (ISR) are enrolled. All patients will be randomized to receive either 12 months or 24 months~     of dual antiplatelet therapy with a P2Y12 receptor antagonist in addition to aspirin, all~     patients continue receiving aspirin indefinitely. The primary efficacy end points of this~     study are the incidence of a composite end point including all cause deaths, myocardial~     infarction, the incidence of Academic Research Consortium defined definite or probable stent~     thrombosis and stroke (MACCE) at 24 months. The primary safety end point is the incidence of~     GUSTO moderate or severe bleeding.~   "
88974|NCT02402478|"~     The purpose of this study is to advance research through collaboration, 4C was established in~     the United Kingdom (UK) in 2009 as a resource in which deoxyribonucleic acid (DNA) and~     biomarker samples were obtained at time of presentation with chest pain linked to detailed~     phenotypic data obtained from electronic health records and participant self-completed~     questionnaires. The investigators sought to explore and assess the current potential of~     setting up a comparable consented research platform by collecting DNA samples and to quantify~     the extent to which diverse NHS hospital information systems are accessible for extracting~     secondary care data (structured and unstructured) for research purposes at scale.~   "
88975|NCT02402465|"~     Dymista, a combined product containing the antihistamine azelastine and the intranasal~     steroid fluticasone, provides superior clinical efficacy to both fluticasone propionate and~     azelastine hydrochloride in the treatment of seasonal allergic rhinitis. The superiority of~     efficacy not only occurs at the initiation of treatment, but persists for its duration. The~     mechanism underlying the superior efficacy of Dymista is not known. This trial focuses on~     examining the effects of Dymista on the dynamics of the allergic response in man using nasal~     provocation with antigen. The investigators will study the relationship between symptoms,~     physiology, cells and mediators.~   "
88976|NCT02402452|"~     This study will evaluate the pharmacokinetics, safety, and tolerability of GS-9857 in adults~     with severe renal impairment and matched healthy control adults.~   "
88977|NCT02402439|"~     The goal of this trial is to gain initial clinical experience regarding the safety and~     efficacy of treating type I diabetes in people who have received a kidney transplant by~     transplanting islets into a new transplant site in the stomach (gastrointestinal submucosa).~     A total of 6 patients will be enrolled in the study and followed for a period of up to 3~     years after the last islet transplant.~   "
88978|NCT02402426|"~     The overall goal of this project is to identify, assess and longitudinally monitor subjects~     who are interested in participating in brain research. Participants will enroll through the~     website, BrainHealthRegistry.org, and provide informed consent prior to any study activities.~     The website will collect a variety of information, including participants' overall health,~     memory complaints, family history of dementia and Alzheimer's disease (AD), mood status,~     sleep, diet, and exercise—all through self-reported online questionnaires. Participants will~     also be ask to take online cognitive tests, and to return to the website at regular~     intervals, to complete follow-up questionnaires and neuropsychological assessments. Everyone~     over the age of 18 is welcome to participate. To join the Brain Health Registry, please visit~     www.BrainHealthRegistry.org.~   "
88984|NCT02402348|"~     The study researchers want to look at the overall effects that Metformin may have on the~     tumor characteristics of Head and Neck cancer cells as well as the interactions that~     Metformin has on the growth or death of tumor cells.~   "
88986|NCT02402322|"~     The aim of this study was to compare two ways of administrating the complementary~     psychological support (scheduled vs. non-scheduled) in an online self-help program for panic~     disorder. In order to do so, the investigators studied: a) If there were differences in the~     intensity and frequency of the symptoms of panic disorder. b) If there were differences in~     the therapeutic adherence between the subjects receiving both kinds of complementary support.~     c) If the more time spent by a psychologist in therapeutic interventions produced the best~     results of therapeutic adherence / symptom improvement.~      Seventy seven subjects followed the online self-help program for 8 weeks; 27 subjects had the~     support of a therapist via phone when they required it, 25 subjects had the support of a~     therapist weekly and 25 subjects were in the waiting list as a control group.~   "
88987|NCT02402309|"~     This is a multi-center, randomized, double-blind, vehicle-controlled, parallel-group study~     designed to evaluate the safety, PK, and exploratory activity of topically-applied NS2~     dermatologic cream administered once-daily (QD) to subjects with ichthyosis secondary to~     Sjögren- Larsson Syndrome (SLS).~      NS2 is expected to trap fatty aldehydes that are pathogenic in SLS patients, and thereby~     diminish the lipid-aldehyde adduct formation that likely results in ichthyosis associated~     with SLS, and potentially reduce the mild dermal inflammation characteristic of SLS.~   "
88988|NCT02402296|"~     combining the non-surgical therapy with a well-tolerated substance that can stimulate~     protective immune responses like B-glucan, might effectively mount resolution pathways~     contributing to resolving of the chronic lesion observed in aggressive forms of periodontal~     disease.~   "
88989|NCT02402283|"~     The purpose of this study is to determine the bioequivalence of Metronidazole benzoate (400~     mg metronidazole per sachet oral granules)/Terix Labs Ltd and Flagyl™ 400 mg Tablets (400 mg~     metronidazole per film coated tablet)/Zentiva.~   "
88990|NCT02402270|"~     The purpose of this study is to learn about a new bowel preparation that uses food to clean~     the colon.~      In order to learn about this new food preparation, some people in this study will get the~     food preparation, and others will get the standard liquid bowel preparation.~      Patients will be randomized (like flipping a coin) to one of five groups:~      Group 1 - Menu A Meal Kit - contains bars, shakes, soup, and a rice bowl Group 2 - Menu B~     Meal Kit - contains bars, shakes, soup, and a rice bowl Group 3 - Menu C Meal Kit - contains~     bars and shakes Group 4 - MoviPrep Group 5 - NuLYTELY~   "
88991|NCT02402257|"~     The investigators previously successfully implemented a central venous catheter (CVC)~     simulation-based mastery learning (SBML) curriculum at Northwestern University. As a result,~     trainee skill improved, complications, including central line associated bloodstream~     infections (CLABSIs) decreased and the curriculum was proven cost-effective. Therefore the~     Veterans Administration Medical Centers (VAMC) decided to implement this training at some of~     their sites as a quality improvement project. The investigators will train faculty at these~     locations to implement the same curriculum at their individual sites. Outcome data will be~     collected to evaluate the outcomes of the quality improvement (QI) project (complications,~     infections, skills).~   "
88992|NCT02402244|"~     This research trial studies the Project: Every Child for younger patients with cancer.~     Gathering health information over time from younger patients with cancer may help doctors~     find better methods of treatment and on-going care.~   "
88993|NCT02402231|"~     Severe peanut allergy is different from other allergic reactions because it can lead to fatal~     reactions and is an invisible disability. There is no cure today. The purpose of this study~     is to treat children and adolescents with severe peanut allergy with oral immunotherapy with~     peanuts under the protection of anti-IgE (immunoglobulin E) antibodies (omalizumab), and~     thereby inducing tolerance to peanuts. The treatment will be monitored by basophil cell~     stimulation (CD-sens).~   "
88994|NCT02402218|"~     This study is being done to compare three ways to give the study drug Harvoni (a tablet that~     includes two drugs also called Sofosbuvir/Ledipasvir) for 12 weeks in people who are infected~     with both Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV). Subjects will~     receive this drug as part of the study. Subjects will be randomized into one of three~     treatment groups:~        1. Usual care in the clinic. This treatment group will receive the standard of care for HCV~          treatment from their health care team.~        2. Usual care plus peer-mentors. In addition to the usual care, this is an investigational~          strategy in which participants assigned to this group will be asked to interact with a~          peer-mentor who is someone who has been cured of their HCV infection.~        3. Usual care plus incentives. In addition to the usual care, this is an investigational~          strategy in which participants assigned to this group will be given incentives after~          completing certain treatment goals during the course of the study.~      HCV treatment with Harvoni is considered the standard of care for HCV and is recommended by~     experts in liver disease and infectious diseases.~   "
88995|NCT02402205|"~     Adjudicated youth often have traumatic stress responses but rarely receive treatment for~     these problems. This study is a randomized controlled trial to evaluate two alternative~     implementation strategies for providing an evidence-based trauma treatment, Trauma-Focused~     Cognitive Behavioral Therapy (TF-CBT), to therapist who treat adjudicated youth in 18~     residential treatment facilities (RTF) in New Hampshire, Vermont, and Connecticut: 1)~     web-based TF-CBT implementation strategy (W), consisting on only web-based training and~     consultation; versus 2) W plus live TF-CBT implementation strategy, consisting of W plus~     face-to face training and phone consultation with TF-CBT experts (W+L).~   "
88996|NCT02402192|"~     The study is proposed to determine the effect of three types of gonadotropins that are~     currently used in protocols of controlled ovarian stimulation in women undergoing in vitro~     fertilization techniques on the kinetics of embryonic development.~   "
88997|NCT02402179|"~     Our objective is to determine the metabolic availability of Tryptophan in white maize using~     the indicator amino acid oxidation (IAAO) technique in adult men.~   "
88998|NCT02402166|"~     The purpose of this study is to gain initial safety, tolerability, pharmacokinetic, and~     efficacy information on SPD489 in preschool children 4-5 years old who are diagnosed with~     ADHD. Generating such data will provide data on the use of SPD489 in the preschool ADHD~     population.~   "
88999|NCT02402153|"~     To evaluate safety issues related to implantation and use of the Hyposafe hypoglycaemia alarm~     device~   "
91525|NCT02369198|"~     The first testing of TargomiRs in the human setting: dose-finding studies in patients with~     recurrent malignant pleural mesothelioma and non-small cell lung cancer~   "
89000|NCT02402140|"~     Primary end-point~      The primary end-point was the influence of pharmaceutical intervention in tacrolimus~     intra-subject variability during the first 3 months after kidney transplant. Coefficients of~     variation were calculated from the average of dose-corrected tacrolimus blood~     concentration(CV= Standard Deviation (SD) x 100/mean) of study visits day 10, 14, 21, 30, 60~     and 90 post kidney transplant.~      Secondary end-points~        1. Secondary outcomes included evaluate percentage of patients who achieved target levels~          of tacrolimus in day study visits 7, 10, 14, 21, 28, 60 e 90 days after kidney~          transplant;~        2. Tacrolimus bioavailability profile during the period of 3 months,characterized by mean~          and standard deviation (SD) of dose corrected tacrolimus blood concentration(ng/ml/mg);~        3. Assess patient adherence through validated questionnaire Portuguese version of Basel~          Scale Adherence Rating Immunosuppressive Drugs (BAASIS) scale. It consists of a~          four-item questionnaire measuring nonadherence to immunosuppressives over the past four~          weeks. This questionnaire assesses omission of single doses or successive doses, timing~          deviations >2h and dose reductions. Responses are given on a six-point scale: never,~          once per month, every second week, every week, more than once per week and every day.~          Patients that answer different from never in any of the four questions are considered~          as nonadherent;~        4. We evaluated renal function eGFR by Modification of Diet in Renal Disease (MDRD);~        5. We evaluated Incidence of Infections;~        6. We evaluated Treated acute rejection episodes;~        7. We evaluated Death cases;~        8. We evaluated Graft loss cases;~        9. We evaluated Discontinuation of immunosuppressive treatment;~       10. We evaluated Hospital readmissions.~      Study Design~      This was a single-center, prospective, randomized and controlled study to evaluate the~     influence of pharmaceutical intervention in tacrolimus intra-subject variability during the~     first 3 months after transplantation. The authors designed the protocol, acquired and~     maintained the data, and conducted the statistical analysis. The protocol was approved by an~     independent ethics committee. All subjects signed a written informed consent before~     enrollment and the study was conducted according to good clinical practices and declaration~     of Helsinki. This study was conducted at Hospital do Rim between February 2014 and December~     2014, 128 randomized and were followed for 3 months after transplantation.~   "
89001|NCT02402127|"~     The purpose of this study is to measure the coefficient of friction of three silicone~     hydrogel, daily disposable contact lenses after 16 hours of wear.~   "
89002|NCT02402114|"~     Post-Traumatic Stress Disorder (PTSD) is an acquired psychiatric condition that occurs after~     exposure to a dangerous or life-threatening event. It is characterized by persistent fear-~     and stress-related symptoms, such as nightmares, flashbacks, depression, anxiety and guilt.~     These symptoms can interfere significantly with patients' lives and in some cases can be~     debilitating. One of the most frequent causes of PTSD is being a victim of a violent,~     interpersonal assault.~      PTSD is felt to be primarily a disorder of memory formation - stressful memories are encoded~     too strongly in a patient's long-term memory, remaining too accessible and present to the~     patient long after the actual threat has passed. In recent years evidence has emerged that it~     may be possible to prevent PTSD by moderating the process of memory consolidation that occurs~     in the hours and days after a traumatic event.~      Early research has suggested that enhancing the body's natural cortisol response to a~     stressful event may be a safe and effective way of moderating the process of memory~     consolidation and promoting adaptive, non-pathological memory encoding. In particular, the~     administration of hydrocortisone, a safe and widely used drug that mimics the body's own~     cortisol hormone, appears to reduce the risk of developing PTSD in patients who have~     sustained a traumatic event. However, this research is still in relatively early stages, and~     requires larger trials to confirm its efficacy. In addition, the research thus far has not~     adequately targeted assault victims, whom Investigator feel are some of the patients most~     likely to benefit from such an approach.~      Investigators propose a prospective, placebo-controlled, double-blinded trial of~     administering single-dose oral hydrocortisone or placebo to 100 assault victims seen in the~     Einstein Medical Center Philadelphia Emergency Department to determine if this approach has~     efficacy in preventing PTSD. This study is designed as a pilot study, with the hopes that the~     data gathered in it can be used to design a larger and more robust trial in the future.~   "
89003|NCT02402101|"~     Transcranial direct current stimulation (tDCS) is a technique that is emerging as a~     prospective therapy for neurologic, psychiatric and addictive disorders. Specifically, anodal~     tDCS applied over the dorsolateral prefrontal cortex (DLPFC) is associated with improvement~     of cognitive functions and mood. Despite an increased use in clinical settings, tDCS suffers~     from limitations, especially regarding the strength and the duration of therapeutic effects.~     Strategies to optimize the conditions for tDCS application suffer from the lack of knowledge~     about its neurophysiological impact. Moreover, tDCS is increasingly used in private settings~     through commercial apparatus and tutorials to make a do-it-yourself device delivering tDCS~     now available on the Internet. This private use worries neuroscientists and health~     authorities. Even if the general impression is that, in controlled conditions, tDCS is safe~     with only mild and transient adverse effects, whether and how tDCS could be used for~     enhancing cognition in healthy subjects are needed to investigate in more detail. The~     investigators believe that a better understanding of some neurobiological effects of tDCS is~     crucial to further tailor tDCS for experimental and therapeutic applications and to define~     recommendations for a private use.~      As the cortex is densely connected with basal ganglia areas, including dopaminergic areas,~     tDCS is probably not only capable to target cortical but also subcortical structures remote~     from the stimulation sites. Some studies suggest that cortical stimulation by other~     approaches, such as transcranial magnetic stimulation (rTMS) leads to an increased~     dopaminergic transmission. The involvement of dopaminergic systems in tDCS effects has been~     investigated only indirectly in pharmacological studies. Thus, the direct effect of the DLPFC~     stimulation by tDCS on dopaminergic transmission is still unknown.~      The aim of this project is to reveal the online impact of a single-session of tDCS applied~     bilaterally over the DLPFC in healthy subjects on the dopaminergic transmission measured by~     PET, combined with the [11C]raclopride bolus-plus-continuous-infusion method.~   "
89004|NCT02402088|"~     The purpose of this study is to examine the role of stress in food craving and food~     consumption in obesity. Using experimentally validated guided imagery procedure, the~     investigators propose to examine the stress response using subjective, physiological and~     neurobiological measurements.~   "
89005|NCT02402075|"~     During neurosurgical resection of brain tumors within brain areas for motor control, it is~     important to monitor motor function. For this muscle motor evoked potentials are used. Those~     are elicited by transcranial and direct cortical stimulation. Motor responses are recorded~     from muscles. In neurosurgical procedures for spinal cord tumors, the same methods are used,~     but additionally motor activity is recorded from the spinal cord. This is called spinal motor~     evoked potentials. It is known that the relation between spinal and muscle motor evoked~     potentials helps to extent the resection of spinal cord tumors. This study implements the~     spinal motor evoked potential into brain tumor surgery and analyses the relationship between~     spinal and muscle motor evoked potentials. With this, detection of injury to the brain area~     for motor control might be discovered earlier and thus tumor resection can be performed~     safely.~   "
89006|NCT02402062|"~     The purpose of this study is to determine the safety and the efficacy of the combination of~     the drugs TH-302 and sunitinib in metastatic neuroendocrine tumours.~   "
89007|NCT02402049|"~     The proposed study will focus on premenstrual syndrome (PMS) symptom alleviation for women~     diagnosed as suffering from the syndrome with the DRSP questionnaire.~      The women will be treated with Homeopatic remedies. The improvement of PMS symptoms will be~     evaluated using the Daily Record of Severity of Problems questionnaire (DRSP). The~     questionnaire will be completed daily by women for 2 months prior to receiving the treatment~     and for 3 months following treatment with a single dose of the homeopathy treatment.~   "
89008|NCT02402036|"~     This is an exploratory biomarker study. Patients with metastatic colorectal cancer will~     receive regorafenib, which is FDA approved in this setting, on day 1-21 of every consecutive~     28 day cycle. Patients will be asked to undergo tumor biopsy at baseline and 2 weeks after~     starting regorafenib. Peripheral blood samples will be collected at baseline 2 weeks after~     starting regorafenib, after initiation of cycle 3, and every 4 weeks thereafter.~   "
89010|NCT02402010|"~     As a practice that incorporates elements of physical exercise, controlled breathing, and~     meditation, yoga is gaining increasing acceptance as an adjunctive intervention for many~     psychiatric disorders. Although yoga has been frequently recommended as a symptom management~     strategy for bipolar disorder (BD), and although there is some preliminary evidence that yoga~     may be helpful in alleviating depressive symptoms, there are no systematic studies on the~     benefits - and potential risks - of the practice of yoga in BD. The primary aim of the~     proposed study is to develop and evaluate the feasibility, acceptability, and safety of an~     adjunctive yoga intervention for bipolar depression in a 10 week pilot randomized controlled~     trial (RCT).~   "
89011|NCT02401997|"~     To determine the ideal sexual abstinence time for producing high quality sperm~   "
89012|NCT02401984|"~     Mental disorders are common in youth and adults. Symptoms of mental are aggravated by~     unemployment. Compared to the working population, the unemployed have higher rates of poor~     health, a tendency toward negative emotionality and depression, show symptoms of exhaustion~     more frequently, and experience disturbed sleep or have a sleep disorder. It can be~     reasonably expected that unemployment in adolescents and young adults causes the same~     symptoms and behaviors as in adults. In those youth with a mental disorder, particularly an~     untreated one, the transfer from school to the employment market can be hindered. At the same~     time, the investigators notice an increase in early disability pensions due to mental health~     issues among adolescents. Thus, the early recognition and treatment of mental disorders and~     psychological strain is crucial in promoting the employment of young people and supporting~     their connection to the employment market.With this project the investigators want to~     implement an early intervention and reach out to unemployed youth. The investigators~     identified the period between graduation and first employment as the ideal moment of~     intervention, because this time period is a critical period in which young people are exposed~     to increasing personal challenges. Conducting an intervention before a psychological stress~     transforms into a mental disorder, can prevent harm and suffering to the afflicted person. In~     addition, early intervention could help prevent the need to enroll in the early disability~     pension program.~   "
89013|NCT02401971|"~     Recent clinical studies have demonstrated a reduction of irinotecan (CPT-11) gastrointestinal~     toxicities when the CPT-11 is administered in combination with thalidomide in patients with~     diagnosis of gastric cancer. The main purpose of this study is to investigate the efficacy~     and safety of thalidomide and CPT-11 in advanced gastric cancer. The investigators will also~     manage to find out the possible interactions between CPT-11 pharmacokinetics and thalidomide~     to explain the previously described gastrointestinal toxicity reduction.~   "
89014|NCT02401958|"~     ABSTRACT Introduction: Rheumatoid arthritis (RA) is a systemic inflammatory, chronic and~     progressive disease that can lead to joint destruction and important functional disability.~     Chronic inflammation, with a substantial increase in the amount of pro-inflammatory cytokines~     in synovial joint, is one of the biggest challenges in controlling RA. Resistance exercise~     has been recognized for positively modulate inflammation in healthy subjects. Objective: To~     evaluate the effect of an acute bout of resistance exercise on serum concentrations of tumor~     necrosis factor alpha (TNF-α), interleukin 1 receptor antagonist(IL-1ra), interleukin 1 beta~     (IL-1β), C reactive protein (CRP), interleukin 6 (IL-6), interleukin 10 (IL-10), and~     cartilage oligomeric matrix protein (COMP) in postmenopausal women with RA and women without~     the disease. Methods: 17 volunteers with RA and 17 without the disease, with a mean age of~     54.7 + 6.63 underwent a resistance exercise session with a set of 12 repetitions at 50% of~     one repetition maximum (1RM ) and a set of 8 repetitions at 75% of 1RM. The exercises~     performed were: knee extension, knee flexion, hip abduction and hip adduction. Blood samples~     were obtained 30 minutes before, 5 minutes before, immediately after, 1 hour, 2 hours and 24~     hours after the exercise session. Serum glucose concentrations prior to exercise were also~     measured. The investigators used the Student's't test, the model of analysis of variance with~     repeated measures and Bonferroni method of multiple comparisons to analyze the data, being~     considered statistically significant levels of p <0.05.~   "
89015|NCT02401945|"~     The purpose of the study is to evaluate the safety and efficacy of intravitreal (IVT)~     administration of DE-120 in subjects with treatment-naive active subfoveal choroidal~     neovascularization (CNV) secondary to age-related macular degeneration (AMD).~   "
89016|NCT02401932|"~     Comparison of malignant and non-malignant disorders associated bone marrow hemophagocytosis.~   "
89017|NCT02401919|"~     COMMUNICATION - Feasibility and effectiveness 'Tell-us Cards' in hospital patients~        -  Objective - To investigate the feasibility and effectiveness of 'Tell-us Cards' on~          patient participation in basic care in hospital settings.~        -  Design - Cluster randomised controlled early trial design (Phase 2B, MRC Framework).~          Patients of two surgical and two medical wards (n=140) will be included in this study.~          Before and after the introduction of the intervention, assessments will take place in~          patients and nurses at these wards.~        -  Intervention - The 'Tell-us card' is a tool to elicit patients preferences and needs in~          basic care. Patients are invited to write down their specific questions and concerns.~          The cards are handed out to patients admitted to the hospital (daily). Patients and~          informal caregivers are invited to use the cards to state their preferences. Nurses are~          instructed to use the cards as a tool in their dialogue with the patient in making care~          plans, during ward rounds or for discharge information sessions.~        -  Comparison - Usual care~        -  Primary outcome - Patient perception of participation in care (Individualized Care Scale~          (ICS)~        -  Secondary - Use and content of the 'Tell-us Cards' actions taken by nurses as a~          consequence of what patients 'tell them' by means of the 'Tell-us Cards', Quality from~          the Patients' perspective (QPP), EQ-5D, and CQ satisfaction with communication & care in~          general~   "
89049|NCT02401503|"~     The CLL2-BAG-trial is a prospective, open-label, multicenter phase-II trial to evaluate the~     efficacy and safety of a sequential regimen of a debulking with Bendamustine followed by an~     induction with GA101 (obinutuzumab) and ABT-199 (venetoclax, GDC-0199) followed by ABT-199~     and GA101-maintenance in CLL patients~   "
89050|NCT02401490|"~     To assess whether albumin administration after an episode of hepatic encephalopathy (≥ grade~     II) improves survival at 90 days (mortality endpoint treated as a composite endpoint death~     and/ or liver transplantation).~   "
89018|NCT02401906|"~     Orbital masses develop at the expense of the orbital structures lacrimal glands, oculomotor~     muscles, optic nerve, meningeal spaces, peripheral nerves, bone wall, orbital fat, lymphoid~     structures or vascular structures. These masses can be tumors, benign or malignant, or~     pseudotumor, mainly represented by specific or non-specific orbital inflammation.~      Pathology is of considerable importance for the diagnosis and the treatment of those masses.~     However, biopsy or surgical resection of the orbital masses is sometimes difficult and~     dangerous outside expert centers.~      The identification of a non-invasive technique for distinguishing tumors from pseudotumors,~     thus avoid in some cases a biopsy, would be a major contribution for the patients.~      The MRI assessment performed routinely in a patient with an orbital mass includes~     morphological sequences T1, T2 fat suppression, T1 injected fat suppression, diffusion. This~     exploration requires, regardless of the performed research, a contrast agent injection (0.1~     mg / kg weight of Gadobutrol®).~      In this research protocol, during the injection of the contrast agent performed during the~     MRI assessment performed routinely, a DCE perfusion sequence, which consists of a repeated~     acquisition at short intervals of a volume gradient echo T1, will be added. This acquisition~     will be preceded by two short series for calibration. The post treatment will include~     parametric permeability cards (Ktrans) and plasmatic volume (Vp), evaluating one or more~     regions of interest in the tumor, normal lacrimal glands, jaw muscles and nasal mucosa being~     the reference. It will also be added a magnetic susceptibility EPI sequence type. All the~     qualitative parameters (T1, T2, T1 injected, distribution, low signal intensity in~     susceptibility) and quantitative (Ktrans, Vp, relative intensity enhancement, apparent~     diffusion coefficient) parameters will be collected.~      The result of the pathological exam of the biopsy or of the surgical specimen, which is the~     gold-standard, will be collected.~   "
89019|NCT02401893|"~     Little is known about factors associated with maintenance of hemagglutinin inhibition (HAI)~     antibodies after influenza vaccination in older adults so the investigators enrolled adults~     ≥50 years.~   "
89020|NCT02401880|"~     The primary aim of this exploratory mechanistic study is to investigate the effects of~     Empagliflozin and Linagliptin on alpha- and beta cell physiology in T2DM patients.~      This study aims to evaluate the effect of the DPP-IV inhibitor linagliptin (as compared to~     placebo) in addition to the SGLT-2 inhibitor empagliflozin on pancreatic alpha and beta cell~     function, as well as several markers of metabolic control.~   "
89021|NCT02401867|"~     The purpose of this study is to assess the acceptability and effectiveness of utilizing~     vaginal self-swabs for HPV DNA testing as compared to provider-collected cervical swabs for~     HPV, as well as to investigate the prevalence of other Sexually Transmitted Infections (STIs)~     among sexually active female-to-male (FTM) transgender adults.~   "
89022|NCT02401854|"~     The ASSERT-III study aims to determine the incidence of sub-clinical (silent) atrial~     fibrillation (AF) among elderly patients with hypertension and at least one other risk factor~     for AF. This will be accomplished by monitoring with a wireless external loop monitor for 30~     to 60 days.~   "
89023|NCT02401841|"~     It is a observational prospective study. The aim of this study is to compare neostigmine vs~     sugammadex in the resolution of neuro-muscular blockade in great obese patients.~   "
89024|NCT02401828|"~     48-week open label randomized phase IV investigator initiated intervention study. The purpose~     of this study is to evaluate whether HIV-1 suppression can be maintained by DTG monotherapy~     in HIV-1 infected, virologically suppressed patients on cART.~      104 adults fulfilling the in and exclusion criteria and on stable cART will be randomized~     over 2 investigational arms.~      The first arm will contain the direct switch population. This population will switch directly~     from stable cART to Dolutegravir mono-therapy on baseline visit.~      The second arm will contain the delayed-switch population. This group will switch from stable~     cART to Dolutegravir monotherapy 24 weeks after baseline visit.~      The main goal is to investigate if Dolutegravir mono-therapy could be non-inferior to cART in~     virological suppressed HIV-1 infected adults.~      If a interim analysis (performed when 40 patients on dolutegravir monotherapy have passed~     week 12) shows that it is safe to continue the study, an additional 30 patients will be~     included on top of the 104 patients needed for the primary endpoint analysis. In contrast to~     the primary endpoint population, these additional 30 patients will have a CD4 nadir <200 but~     a CD4 >350 at the time of the screening visit. Besides that, these 30 patients will have to~     fulfill all other in and exclusion criteria of the primary endpoint population (specifically~     a viral load never >100.000). These 30 patients are part of a pilot study looking at the~     possibility to broaden the eligible population in a future larger randomized clinical trial.~   "
89025|NCT02401815|"~     The goal of this clinical research study is to learn how PLX9486 may affect cancer cells with~     certain mutations in the KIT gene, specifically in patients with types of advanced solid~     tumors including Gastrointestinal Stromal Tumor (GIST).~      PLX9486 is designed to block KIT gene mutations. These mutations can cause cancer and cancer~     cell growth. By blocking these mutations, the drug may kill the cancer cells with the~     mutation and/or stop the tumor from growing. By combining PLX9486 with PLX3397 and PLX9486~     with Sunitinib, the investigators hope to block most gene mutations in KIT.~   "
89026|NCT02401802|"~     This trial will compare the efficacy of 2 different sets of dietary recommendations to be~     followed before colon cleansing for colorectal cancer screening colonoscopy.~   "
89027|NCT02401789|"~     The objective of the present study is to evaluate if loss of multiple adjacent teeth will~     cause proportionally greater tissue diminution than the loss of single teeth the possibility~     of counteracting unfavourable ridge modeling after multiple tooth extractions by placing~     implants in the fresh extraction sites soft tissue alterations at implants and adjacent teeth~   "
89028|NCT02401776|"~     -  The primary objective of this study is to assess the effect of an energy drink on~          ventricular repolarization as measured by the interval between the cardiac Q wave and~          the cardiac T wave (QT interval)obtained from the body surface ECG.~        -  The secondary objective is to assess the effects of an energy drink on heart rate and~          blood pressure (hemodynamic effects).~      To place the observed changes in context, comparison will be made to a commonly consumed~     drink, coffee: Starbuck's K-cup Breakfast Blend.~   "
89029|NCT02401763|"~     Nasopharyngeal carcinoma (NPC) is the tenth leading cancers in Taiwan and investigating its~     biomarker is important for understanding the mechanism of its pathogenesis.~   "
89030|NCT02401750|"~     This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 3~     study to evaluate the efficacy and safety of the administration of multiple doses of~     Oxycodone Hydrochloride plus Naltrexone Hydrochloride (a) or Oxycodone Hydrochloride plus~     Naltrexone Hydrochloride (b) in patients who have undergone primary, unilateral, distal first~     metatarsal bunionectomy with osteotomy and internal fixation.~   "
89031|NCT02401737|"~     This Phase 1b trial will assess the dose-related safety and PK profile of different doses of~     NVR 3-778 in patients with chronic hepatitis B. Additionally,changes in patients' serum HBV~     DNA levels and other virologic efficacy parameters will be assessed.~   "
89032|NCT02401724|"~     After a stroke affecting the right side of the brain, many patients are affected by spatial~     neglect: the damage to the brain causes them to ignore the left side of their surroundings.~     At its most extreme they may be unaware that they have a left side, or believe that it is~     moving normally when it is in fact paralysed. In milder cases, people may be unable to~     recognise touch on the left side if their right side is also being touched, or objects in~     their left visual field if something is visible to their right. Neglect alters peoples'~     quality of life profoundly, often renders them more dependent on others to undertake basic~     activities of daily living, and makes effective rehabilitation much more difficult.~      The limited success of current treatment approaches indicates gaps in understanding of the~     underlying mechanisms of neglect and its recovery. Recent data suggest that the problems in~     responding to the left side are a result of an imbalance of activity in those parts of the~     brain responsible for deciding which side to pay attention to. It might therefore be possible~     to help people with neglect by rebalancing the brain either by increasing activity in the~     damaged side, or alternatively by reducing activity in the undamaged side. In this pilot~     study, the investigators will test whether they can help by doing the second of these things.~      The investigators propose to conduct a pilot clinical trial to explore whether using electric~     currents to temporarily modify the activity of specific areas of the intact side of the~     brain, influences recovery from neglect, when used either alone, or in combination with a~     training method that has previously appeared promising as a treatment. Brain activity will be~     modified using a technique called transcranial direct current stimulation (tDCS), in which~     small electric currents are applied to the scalp with a wire covered in damp cotton pads.~     This will be done over the specific parts of the brain that are responsible for focusing~     attention to one side.~      The investigators will compare the clinical outcomes of four interventions (1: behavioural,~     2: tDCS, 3: a combination of both and 4: control).~      The investigators hope that these studies will advance their understanding of what treatments~     may help people with neglect, and how they might work.~   "
89033|NCT02401711|"~     The purpose of this study is to compare the effectiveness of two methods, safety curriculum~     in addition to online training alone, for teaching patient safety to surgery residents.~     Despite multiple studies evaluating educational safety curricula, the best methods for~     teaching residents about patient safety is unknown. It is hypothesized that empowering~     surgery residents to actively engage in behaviors to increase patient safety may lead to a~     higher quality perioperative care and communication.~   "
89034|NCT02401698|"~     The past 10 years of research in post stroke patients have shown certain types of~     rehabilitation can help neuronal plasticity of the brain. Transcranial magnetic stimulation~     (TMS) can be used to monitor this plasticity by mapping the brain's function (measuring brain~     activity). Recent research suggests that TMS can be used for both prognosis (determining~     future function) and to determine what type of rehabilitation therapy will work best after~     stroke. The purposes of this research study are to: 1) determine changes in cerebellar~     activity after motor cortical stroke 2) compare changes in recovery of motor function with~     changes in cerebellar - motor cortex connections; 3) determine the ability of TMS to~     predict functional outcome after stroke. The primary hypotheses are: 1) functional recovery~     will be correlated with TMS changes (as measure of motor threshold (MT), intracortical~     inhibition, cerebellar cerebral inhibition (CBI), motor evoked potentials (MEPs) and~     recruitment curves; 2) baseline TMS will predict future functional outcomes.~   "
89035|NCT02401685|"~     POSNOC is a pragmatic, randomised, multicentre, non-inferiority trial.~      Aim For women with early stage breast cancer and one or two sentinel node macrometastases, to~     assess whether adjuvant therapy alone is no worse than adjuvant therapy plus axillary~     treatment, in terms of axillary recurrence within 5 years.~      Stratification: Institution, Age (<50, ≥50), Breast-conserving surgery (BCS) or mastectomy,~     Estrogen receptor (ER) status (positive, negative), Number of positive nodes (1, 2),~     Intra-operative sentinel assessment using OSNA (yes, no).~      Interventions The study will compare adjuvant therapy alone with adjuvant therapy plus~     axillary treatment (axillary node clearance (ANC) or axillary radiotherapy (ART)).~      Sample Size: 1900 participants~      Follow-up: Participants will be followed up for 5 years.~      Adjuvant Therapy: All participants will receive adjuvant systemic therapy (chemotherapy~     and/or endocrine therapy). All participants may receive breast/chest wall radiotherapy.~     Axillary and supraclavicular fossa radiotherapy is not allowed when randomised to adjuvant~     therapy alone.~   "
89036|NCT02401672|"~     Cigarette smoking remains a significant public health concern. A magnetic field applied to~     the outside of the skull can produce electrical activity in the brain without significant~     pain or the need for anesthesia. Sessions of magnetic stimulation or superficial stimulation~     that does not reach the brain will be used to determine if magnetic stimulation can reduce~     cue-induced craving and cigarettes consumption in adult nicotine-dependent cigarette smokers.~     This project may lead to a new therapy for smoking cessation.~   "
89037|NCT02401659|"~     Valiosa is a national, multicenter and prospective post market study. The objectives of the~     study are to generate and validate an instrument to evaluate patient and clinician's~     satisfaction with remote monitoring and to create awareness of the importance of remote~     monitoring among patients, physicians and decision makers.~   "
89038|NCT02401646|"~     The aim of this study is to identify the effect of Polygoni Multiflori Radix complex extract~     on memory improvement using Rey-Kim scale for healthy people.~   "
89039|NCT02401633|"~     Out-of-hospital cardiac arrest (OHCA) is one of the leading causes of mortality in the~     industrialized world. Bystander CPR before arrival of the Emergency Medical Service (EMS) is~     a positive predictor of survival. During the last decade, the best form of bystander CPR has~     been debated. Chest Compression Only CPR (CO-CPR) has been advocated as a preferable method~     in situations where the bystander has no previous knowledge in CPR, both because its believed~     to be equally efficient but also a simplified form of CPR that could lead to a higher~     incidence of bystander-CPR.~      The purpose of this study is to perform av run-in period with focus on safety and feasibility~     prior to the launch of a larger randomized trial which has a primary end-point of survival.~     This study will compare OHCA with standard CPR (S-CPR; chest compressions and rescue breaths~     in a 30:2 fashion) compared to CO-CPR.~   "
89040|NCT02401620|"~     The purpose of the present study is to assess the measurement properties of a tolerability~     questionnaire. The results obtained in patients with Rheumatoid Arthritis (RA) being treated~     will be robust and will assess the patient's tolerability to the treatment. Patients with~     greater tolerability will be more satisfied with their treatment.~   "
89051|NCT02401477|"~     This study assessed eradication rate of dual therapy with high doses of Ilaprazole 40mg BID~     and Amoxicillin 750mg QID for 14 days on Helicobacter pylori infection.~   "
89052|NCT02401464|"~     The purpose of this study is to evaluate the bioequivalence of a single oral dose of 2~     different drug forms of TAK-536 pediatric formulation and a single oral dose of TAK-536~     commercial tablet in healthy Japanese adult male participants.~   "
89041|NCT02401607|"~     The Karasek Job Content Questionnaire includes 2 dimensions: the psychological demands at~     work, and the latitude decision. The combination of these two characteristics explains the~     degree of exposure of a worker to stress. Indeed, a worker is under pressure (job-strain)~     when workload is important and autonomy is poor. The Sumer study was conducted in France on~     25,000 employees and classified occupations taking into account psychological demands and~     latitude decision of occupations. No publication on emergency physicians' responses to~     Karasek questionnaire is referenced, even though theirs exposures to burnout is known. A~     preliminary study on 19 emergency physicians of the CHU of Clermont-Ferrand illustrates~     concretely this extraordinary situation, with the lowest decision latitude and the highest~     psychological demands ever recorded. Moreover, there are no data on results at the Karasek~     questionnaire under different conditions within the same participant, i.e. responses to the~     Karasek questionnaire is supposed similar and reflect a constant perception of work.~     Additionally, several biomarkers of stress have been proposed, in particular DHEAS due to its~     long half-life of 16 hours. To our knowledge, the relationship between biomarkers of stress~     and tension at work with Karasek model has never been studied, like this relations with other~     wellness questionnaires. Comparisons between emergency health care workers are also lacking.~      Our study proposes to evaluate the perception of emergency medicine with Karasek~     questionnaire, and to assess possible changes of its perception and in biological response~     between two conditions: after a night shift and on a control day (workday), in emergency~     health care workers.~   "
89042|NCT02401594|"~     PRONOMOS is an international multicentre, interventional, parallel, randomised, double-blind~     non-inferiority study comparing rivaroxaban 10mg od to an active comparator, enoxaparin 4000~     UI od in 4040 valid subjects requiring orthopaedic surgery (except low risk such material~     removal foot surgery or hallux valgus without patient risk factor [6], and major orthopaedic~     surgeries for femoral neck and trochanteric fractures, THR, TKR)~      Pre-randomization treatment with LMWH anticoagulant is allowed for a maximum duration of 24~     hours. However, only a single pre-randomization dose of LMWH is allowed. After randomization,~     patients allocated to the rivaroxaban arm will receive rivaroxaban 10 mg once-daily started~     6-10 hours provided haemostasis has been established after surgery or 24h hours after LMWH~     injection if needed for the intended treatment duration of 2 to 12 weeks based on medical~     judgment (according to immobilization). Patients allocated to the comparator arm will receive~     enoxaparin once daily for the same intended treatment duration. All patients will have a~     30-day observational period after cessation of treatment.~   "
89043|NCT02401581|"~     Benign hypertrophy of the prostate (BPH) is the most frequent pathology in the urinary tract~     of middle-aged men. In recent years, to enable BPH treatment with larger volumes and to~     reduce the risk of hemorrhage known to be associated to the transurethral resection of~     prostate treatment, transurethral photovaporisation of the prostate (PVP ) with the~     GreenLight (GL) XPS 180 W was developed. Therefore, the question arises to maximally reduce~     the length of catheterization to facilitate outpatient surgical management of prostate~     adenoma.~      In the investigators study, the investigators propose to evaluate the failure rate of an~     early removal of the catheter 3 hours post-operative after a PVP procedure with GL 180 W/XPS~     in selected patients on general anesthesia or spinal anesthesia. To this end, the~     investigators realize a national multicenter prospective study including 300 patients. The~     effectiveness of this model of management is defined by absence of a need for~     re-catheterization in the post -operative period of 24 hours.~   "
89044|NCT02401568|"~     Compare various dynamic biomechanical markers (distances and angles) in the wrist during~     dynamic CT studies in three groups of patients: Normal subjects, with scapholunate~     instability and with other types of wrist instability.~   "
89045|NCT02401555|"~     The purpose of this study was to evaluate the performance of the Bio-Rad Geenius HIV 1/2~     Supplemental Assay, a single-use immunochromatographic assay for the confirmation and~     differentiation of individual antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1~     and HIV-2) in fingerstick whole blood, venous whole blood, serum, or plasma samples (EDTA,~     heparin, and sodium citrate).~   "
89046|NCT02401542|"~     This is a Phase 1b/2, randomized, double-blind, placebo-controlled, multicenter,~     parallel-group study of B-701 plus docetaxel versus placebo plus docetaxel in the treatment~     of locally advanced or metastatic urothelial cell carcinoma in subjects who have relapsed~     after, or are refractory to standard therapy.~   "
89047|NCT02401529|"~     This study aims to evaluate the effect of postoperative systemic rapid onset and short acting~     dexamethasone followed by a tapering dose of oral prednisolone on post-tonsillectomy~     morbidities. Half of the patients who comply with the inclusion criteria were selected to~     receive a single postoperative dose of intravenous dexamethasone followed by oral steroids;~     the second group received placebo.~   "
89048|NCT02401516|"~     ASH has a high prevalence rates and considered one of the major modifiable risk factors for~     cardiac vascular diseases (CVD) and brain vascular diseases (BVD) and one of the most~     important public health problems. Researches estimated 62% of BVD can be attributed to ASH.~     In Brazil, prevalence of hypertension ranged from 21.6% in 2006 to 42.4% in 2011. CVD are~     responsible for high frequency of hospitalization, and in 2009, 91,970 hospitalizations due~     to CVD cost public treasury more than 165 million reais. ASH neurological pathophysiology~     studies has shown that excessive activation of sympathetic autonomic nervous system (SANS)~     seems to have an important role in genesis and maintenance of ASH, with current studies aimed~     to understand this relationship.~      Pathways used by SANS for immediate control of BP (wich are reticulate formation, bulb and~     cortex) appear to be similar to pathways used for postural control reflex (reticulate~     formation, bulb, cortex, among others), which are also used by Postural Reprogramming Insoles~     (PRI) for posture adequacy. Due to this similarity in reflex activation areas, it is believed~     that PRI may have some effect on BP regulation.~      There are many ways to treat postural changes and one of them is posturology, which is based~     on therapeutic use of postural reprogramming insoles (PRI). PRI activates tonic-postural~     system, rebalancing muscles, joints and bony structures of body segments, and returning~     individual to an appropriate posture.~      The PRI is composed of a central artifact, situated in reflex zone full of somatosensory~     stimuli captors, which generates a frequency of vibration that promotes postural adaptation.~   "
91609|NCT02368093|"~     Rheumatoid arthritis were randomized to a 6-month treatment of oral dextromethorphan~     hydrobromide or placebo as an add-on therapy to traditional disease-modifying anti-rheumatic~     drugs (DMARDs). Disease activity were assessed.~   "
89053|NCT02401451|"~     The 12-lead ECG is an essential tool in cardiovascular assessment. Novel technology has the~     potential to improve the diagnostic yield of arrhythmias, whilst improving the patient~     experience.~      The RhythmPadGP is a novel device which acquires a 6-lead ECG without the need for the~     patient to undress.~      The aim of the study is to assess the ability of the device to diagnose cardiac rhythms.~      Simultaneous recording of the RhythmPadGP 6-lead ECG will be undertaken at the same time as~     the standard 12-lead ECG.~      The 12-lead ECGs and 6-lead ECGs will be analysed by a Cardiologist, who will be blinded to~     each set of ECGs and the automated diagnostic report produced by the RhythmPadGP device.~      Such a novel diagnostic tool could replace the standard 12-lead ECG for rapid assessment and~     diagnosis of arrhythmias. Additionally, as calls for a national screening programme to detect~     atrial fibrillation (and prevent AF-related thromboembolism) currently intensify, the~     RhythmPad has the potential to revolutionise how we screen our patients.~   "
89054|NCT02401438|"~     5D and 2D ultrasound will be done for pregnant women within 72hours before preterm delivery~     to determine estimated fetal weight by ultrasound. The estimated fetal weight by 5D and 2D~     ultrasound will be compared to the actual birth weight to determine accuracy of 5D ultrasound~     in predicting actual birth weight .~   "
89055|NCT02401425|"~     The purpose of this study is to compare the success rate of letrozole and misoprostol versus~     misoprostol alone for medical termination of first trimester pregnancy.~   "
89056|NCT02401412|"~     Hollister Incorporated is studying stoma related cost of care related to a new ostomy skin~     barrier that is designed to maintain adhesive properties and good peristomal skin health~     compared to other currently marketed barriers.~   "
89057|NCT02401399|"~     Patients undergoing sleeve gastrectomy aara randomized into 3 groups:preoperative regular~     diet , preoperative balanced energy high protein formula and Immunonutrition~     formula.Postoperative pain and acute phase reactants at 24hours after surgery are~     investigated.~   "
89058|NCT02401386|"~     In this randomized, usual therapy-controlled study, 62 patients with fibromyalgi (FM) were~     recruited with a ratio of 1:1. Trained and guided by Eight Brocades (EB) certified~     physicians, participant practiced EB one hour, twice a week for 12 weeks. Evaluation will be~     based on standard scales of pain, FM symptoms severity, degree of fatigue, depression, sleep~     quality and quality of life.~   "
89059|NCT02401373|"~     This is a single center, open, dose-escalation phase 1 clinical trial. This study will~     determine the safety and side-effect profile, and immunogenicity of an investigational~     Ad5-EBOV vaccine in Healthy Adult Africans aged between 18-60 years in China.~   "
89060|NCT02401360|"~     This study assessed the efficacy of an oral hygiene regimen relative to a standard marketed~     toothpaste and manual toothbrush.~   "
89061|NCT02401347|"~     The aim of this single-arm phase 2 clinical trial is to evaluate the anti-cancer activity of~     Talazoparib (also known as BMN 673) in patients with advanced breast cancer with specific~     genetic or tumor genomic alterations. Patients with either triple-negative or HER2-negative~     breast cancer are eligible.~   "
89062|NCT02401334|"~     This prospective clinical study will evaluate the safety and efficacy of the Cook®~     Antimicrobial Hernia Repair Device containing an antimicrobial to reinforce soft tissue~     during ventral or incisional hernia repair in clean-contaminated, contaminated, and~     dirty-infected (i.e., Class II, Class III, and Class IV) surgical fields. Up to 30 patients~     will be treated with the Cook® Antimicrobial Hernia Repair Device and patients will be~     followed for 12 months.~   "
89063|NCT02401321|"~     This pilot clinical trial studies the Taking Care of Her program in patients with stage III~     or IV ovarian cancer and spouse caregivers. This counseling program may equip the spouse~     caregiver with skills to support and nurture the patient through initial diagnosis and~     treatment. It may also help patients and spouse caregivers improve communication and coping~     skills.~   "
89064|NCT02401308|"~     The purpose of the proposed study is to demonstrate that the functional outcomes of DBS~     surgery utilizing the asleep technique are not inferior to those reported for traditional~     awake DBS technique.~   "
89065|NCT02401295|"~     The purpose of this study is to evaluate the safety and tolerability associated with the~     combination of ATRA/celecoxib/itraconazole as maintenance therapy given after an autologous~     stem cell transplant in relapsed multiple myeloma patients.~   "
89066|NCT02401282|"~     This study examines the way attention may be linked to temperamental risk for anxiety, social~     behavior and brain processes. The study aims to see if temperamentally at risk youth display~     an attention bias towards threat, and if anxiety symptoms can be reduced through attentional~     bias modification training.~   "
89067|NCT02401269|"~     CVD accounts for 15% of all deaths in Malawi. Both HIV and ART are risk factors for CVD~     through direct toxic and inflammatory cardiovascular effects. (44,45). At the moment, one out~     of every 10 Malawian is HIV positive and roughly 8 out of 10 of those infected are now on ART~     (2). Therefore, HIV and ART may be contributing to the burden of CVD in Malawi. Currently,~     there are only a few studies assessing CVD risk in the HIV patient population on ART. In~     Malawi, no such studies exist. Therefore, the investigators propose a novel study assessing~     baseline cardiovascular disease risk using two novel ultrasound technologies in HIV patients~     on ART. Cardiovascular disease risk will be assessed using surrogate cardiovascular markers~     of disease. These surrogates include markers of endothelial function and cardiovascular~     modulating inflammatory biomarkers. The inflammatory biomarkers measured will be TNF-alpha,~     IL-6, and CRP. Aspirin, by way of its antiplatelet and anti-inflammatory effect has been~     demonstrated to inhibit atherosclerosis by way of decreasing TNF-alpha, IL-6, CRP and~     improving endothelial function. Therefore a second aim of the study will be to demonstrate~     that aspirin improves surrogate markers of atherosclerosis.~   "
89101|NCT02400827|"~     For prepubertal patients, cryopreservation of ovarian tissue is the only option available to~     preserve their fertility before cancer treatment. But ovarian autograft raises the issue of~     the risk of reintroduction of potentially malignant cells. The aim of our study is to develop~     a specific and sensitive method for residual disease detection in the ovarian tissue from~     patients treated for a solid tumor during infancy, whose fertility may have been compromised~     by treatments and who benefited of ovarian tissue cryopreservation.~   "
91610|NCT02368080|"~     This study compares the lung clearance index (LCI) in cystic fibrosis and healthy adults~     obtained with two different multiple breath nitrogen washout (MBWN2) devices. Each~     participants will perform the test (LCI) in duplicate on each device.~   "
89068|NCT02401256|"~     The CYP2B6 enzyme metabolizes a growing number of clinically important drugs such as the~     anti-HIV drug efavirenz, but its activity in the liver is highly variable, which may lead to~     failure of therapy or toxicity and unpredictable drug interactions. Genetic and several~     nongenetic factors affect the activity of CYP2B6. The goal of this study is to determine the~     impact of simultaneous autoinhibition/autoinduction and CYP2B6 genetics on CYP2B6 activity,~     efavirenz exposure and efavirenz-mediated drug interactions. The pharmacokinetics and drug~     interactions will be determined on three occasions in a total of 60 healthy volunteers. The~     whole study will have 4 phases. A) Phase 1 (baseline control): using selective probe~     substrates, the baseline activities of CYP2B6 (bupropion), CYP2C8 (montelukast) and OATP1B1~     (rosuvastatin) are determined. B) Phase 2 (inhibition): the metabolism and pharmacokinetics~     of a single 600 mg oral dose of efavirenz) and the activities of CYP2B6, CYP2C8 and OATP1B1~     (inhibition) are determined. C) Phase 3 (treatment phase): After completing phase 2, subjects~     take 600 mg/day efavirenz at home for 17 days. C) Phase 4 (induction and inhibition): At the~     end of phase 3, steady state metabolism and pharmacokinetics of efavirenz and the activities~     of CYP2B6, CYP2C8 and OATP1B1 will be determined. Efavirenz serves as a model substrate,~     inhibitor and inducer of CYP2B6 (and other drug disposition proteins). Bupropion~     4-hydroxylation is an alternative in vivo probe of CYP2B6 activity and will be studied here~     in addition to the metabolism and pharmacokinetics of efavirenz.~   "
89069|NCT02401243|"~     Primary Objective:~      The primary objective of this study is to obtain efficacy and safety descriptive data on 2~     different titration algorithms: the INSIGHT titration algorithm (self-titration of 1~     unit/day) and the EDITION trial algorithm with insulin glargine 300 units/mL when given as~     basal insulin in uncontrolled type 2 diabetes mellitus (T2DM) patients on basal insulin with~     or without non-insulin anti-hyperglycemic agent (NIAHA) or in insulin naïve patients.~      Secondary Objective:~      The secondary objective is to gain additional efficacy and safety data (glycated hemoglobin~     [A1C], fasting plasma glucose [FPG], 7-point self-measure plasma glucose [SMPG], insulin dose~     and weight) and determine patient related outcome and health care professional satisfaction~     as it pertains to each titration regimen.~   "
89070|NCT02401230|"~     The purpose of this study is to determine whether the use of rectal lubricants can affect how~     well the medication, Truvada, will work to prevent infection with HIV when someone is exposed~     to HIV in the rectum.~   "
89071|NCT02401217|"~     The primary objective of this study is to assess the comparative gastrointestinal tolerance~     of normal term infants to two experimental milk-based powdered formulas compared with a~     standard milk-based powdered formula.~   "
89072|NCT02401204|"~     Infections with multiply antibiotic-resistant bacteria represent a major cause of preventable~     morbidity and mortality amongst hospitalized neonates worldwide. In Southeast Asia, where~     antibiotic-resistance is a major problem, Gram-negative bacteria account for the majority of~     such infections. The most common pathogens are Acinetobacter spp., Pseudomonas aeruginosa,~     Enterobacter spp., Escherichia coli and Klebsiella pneumonia. The great majority of~     infections with these pathogens represent asymptomatic carriage, though in the absence of~     routine screening for asymptomatic carriage reliable estimates of the prevalence, rates of~     transmission between patients, and rates of importation from the community are lacking.~     Moreover, current understanding of the degree and manner in which different antibiotics act~     to select for such resistant organisms is rudimentary.~   "
89073|NCT02401191|"~     Primary Objective:~      To assess the safety of twice-daily fexofenadine 60 mg/phenylephrine 10 mg (FEX60/PE10)~     combination tablet in patients with allergic rhinitis.~      Secondary Objective:~      To evaluate the effectiveness of a twice-daily FEX60/PE10 combination tablet on nasal~     symptoms (sneezing, rhinorrhea, and nasal congestion), and daily activity impairment.~   "
89074|NCT02401178|"~     The incidence of atopic dermatitis has increased dramatically in this years. Atopic~     dermatitis occurs due to complex interactions between genetic and environmental factors. One~     of the genes that consistenly linked with AD occurences is filaggrin gene (FLG gene).~     Mutation on the gene can induce disruption in epidermal cytoskeleton aggregation which serves~     to form protein-lipid, thereby disrupting the skin permeability to water and outside~     particles such as allergens.8-14 Several attempts have been made to prevent the occurences~     and progressivity of AD, one of them is LCPUFA supplementation. Until now, the clinical and~     meta-analysis studies have shown inconsistent results, but LCPUFA intervention in early life~     gives more consistent and protective results. In this study investigators would like to know~     about the influence of FLG gene mutation to the occurrence of atopic dermatitis, to know the~     composition of LCPUFA in early life in order to see protective effects of several LCPUFA, to~     see the influences of FADS1 and FADS2 gene polymorphism towards LCPUFA concentration from~     umbilical artery and buccal swab in early life and at the time AD occurs, to know about the~     diet at the time of AD occurrence, and to know the role of the ratio of DHA towards AA level~     in the development of AD due to their antagonistic effects, and to see the interactions~     between FLG gene, FADS gene and LCPUFA level in the development of AD.~   "
89075|NCT02401165|"~     GADD34 is an inducible cofactor of protein phosphatase 1, which has an important role in the~     Unfolded Protein Response (UPR). UPR is a cellular response to ER stress which is implicated~     in several autoimmune diseases. GADD34 has been shown to be necessary for proinflammatory~     cytokine production in response to viral infection in murine models. Nevertheless, the role~     of GADD34 in cytokine production in humans remains to be elucidated. Here, we investigate the~     interest of GADD34 in rheumatoid arthritis (RA), in which proinflammatory cytokines have an~     important pathogenic role.~      A case-control study on GADD34 gene expression in PBMC of patients (n=75) with RA and age-~     and sex-matched healthy controls (n=25). GADD34 gene expression levels in PBMC were measured~     by quantitative PCR.~   "
89111|NCT02400697|"~     The American College of Obstetrics and Gynecology, American Academy of Pediatrics and the~     World Health Organization have recently published recommendations related to placental~     transfusions in preterm infants. This project will review outcomes of preterm infants~     following a quality improvement implementation process in several delivery centers in~     Indiana. Centers involved in this project are also part of the Indiana Vermont Oxford Network~     (IRB#1003-84). Data is recorded for that network and the investigators site will be reviewing~     that data every 3 months from infants who have completed the Vermont Oxford Network~     collection. This project will specifically look at the incidence of intraventricular~     hemorrhage, necrotizing entercolitis, periventricular leukomalacia, sepsis and death~     following the implementation of the ACOG recommendations.~   "
89076|NCT02401152|"~     The objective of this study is to investigate whether two newly developed sports drink will~     affect gastric distress (GD) and running performance (RP) compared to an iso-caloric control~     drink both in a short and longer distance run. Furthermore, the effect of the newly developed~     sports drinks on gastric emptying will be investigated.~      The study will consist of 3 parts. Firstly, a randomized cross-over design is used for the~     short distance run and the effects on GD and RP. Secondly, a parallel design is used to study~     the effects of the drinks on GD and RP during a longer distance run. Thirdly, the gastric~     emptying tests will be performed in a randomized cross-over design. Participants will be~     asked to fill in questionnaire on the gastric distress they experience. 40 participants will~     be enrolled to participate in part 1 and part 2. 10 out of 40 will participate in part 3 of~     the study.~   "
89077|NCT02401139|"~     This study is a Randomized Controlled Trial, investigating the safety and efficacy of~     administration of ketamine as a potential treatment for depression.~   "
89078|NCT02401126|"~     The main purpose of this study is to determine whether dietary nitrate supplementation via~     concentrated beetroot juice improves central and peripheral cardiovascular control and~     physical capacity in patients with systolic heart failure.~   "
89079|NCT02401113|"~     This randomized, placebo-controlled, double-blind study was designed to investigate the~     efficacy and tolerability of Ursolic Acid of Loquat Extract for treatment of muscle function~     improvement with relatively health adults. 54 subjects received 500 mg of Loquat Extract per~     day or a placebo for 12 weeks.~   "
89080|NCT02401100|"~     The purpose of this study is to determine whether reduced rectal blood flow is associated~     with the extent of surgery when performing an operation to remove rectal cancer. The~     investigators also aim to describe any relation of reduced rectal blood flow, as well as~     raised inflammatory biomarkers in blood and tissue, to the occurrence of anastomotic leakage.~     The patients will be recruited at Umeå University Hospital and all patients who are planned~     to undergo anterior resection for rectal cancer and able to consent are eligible for this~     study. Rectal blood flow measurements will be conducted with Laser-Doppler technology using~     noninvasive measuring probes. Preoperative and postoperative blood sampling as well as~     postoperative drain fluid collection will take place. Perianastomotic tissue will also be~     collected. In the postoperative period, any occurrence of surgical complications especially~     anastomotic leakage, will be noted. Blood flow and biomarkers will be assessed in relation to~     type of mesorectal excision (total or partial) and correlated to anastomotic leakage.~     Standard statistical tools will be utilized, such as parametric, non-parametric tests and~     logistic regression, as appropriate. The study will recruit approximately 40 patients during~     three consecutive years.~   "
89081|NCT02401087|"~     The aim of this observational study was to evaluate, based on the intraoperative anesthetic~     that is routinely carried out at the Department of Day Surgery, the difference in timing of~     the patient's discharge from the hospital (ie when the patient has autonomous demabulation~     and urination spontaneous) in patients undergoing correction of varicocele according Marmar.~   "
89082|NCT02401074|"~     Airway irritation, cough and bronchial spasm are common symptoms in patients with airway~     inflammatory diseases such as asthma. The primary focus of this exploratory study is to~     determine if there is an increase in tissue temperature in airway mucosa during asthma~     exacerbation. The results of this study will bring a better understanding of the potential~     involvement of an increase in airway mucosa temperature in the pathogenesis of various~     symptoms in these patients. The finding should help to advance the development of new~     therapeutic strategies for these debilitating diseases.~   "
89083|NCT02401061|"~     Pre-clinical and clinical evaluations show that PRTX- 100 has biological activity that may~     lead to improved platelet levels where these are decreased due to immunological pathologies~     and that PRTX-100 has an acceptable safety profile. In vivo treatment with PRTX-100 has been~     shown to raise platelet counts in a mouse model of immune thrombocytopenia (ITP). The primary~     objective of the study is to assess the efficacy of PRTX-100 in terms of platelet response in~     patients with chronic/persistent ITP.~   "
89084|NCT02401048|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of the~     combination treatment of ibrutinib and MEDI4736 in patients with relapsed or refractory~     lymphomas.~   "
89085|NCT02401035|"~     The purpose of this study is to characterize the pharmacokinetics (PK) and safety of~     intravenous (IV) pantoprazole in patients 1 to 16 years old who are candidates for acid~     suppression therapy.~   "
89086|NCT02401022|"~     To evaluate the efficacy and safety of AZD8529 for smoking cessation in female smokers.~   "
89087|NCT02401009|"~     The primary goal of the CIBMTR Research Program is to improve the safety and effectiveness of~     hematopoietic cell (HC) transplantation for both donors and recipients.~   "
89088|NCT02400996|"~     A single institutional study of Pancreatic Endocrine Neoplasms over 18 years.~   "
89089|NCT02400983|"~     The main objective of this study is to verify the effectiveness of the new ACAP ® Confirm~     algorithm in the automatic management of atrial capture.~   "
89090|NCT02400970|"~     For prepubertal patients, cryopreservation of testicular tissue is the only option available~     to preserve their fertility before cancer treatment. But testicular autograft raises the~     issue of the risk of reintroduction of potentially malignant cells. The aim of our study is~     to develop a specific and sensitive method for residual disease detection in the testicular~     tissue from patients treated for a solid tumor during infancy, whose fertility may have been~     compromised by treatments and who benefited of testicular tissue cryopreservation.~   "
89091|NCT02400957|"~     Evaluate the effectiveness of silver nanoparticles incorporated into the primer orthodontic~     Transbond XT in preventing enamel demineralization adjacent to brackets.~   "
89092|NCT02400944|"~     The purpose of this study is to learn how different lifestyle factors, such as cigarette~     smoking and body weight, change after a diagnosis of bladder cancer, and how they influence~     who gets a bladder cancer recurrence and who does not.~   "
89236|NCT02399072|"~     This study seeks to better characterize relationships between visual function and the~     progression (worsening) of geographic atrophy (GA) due to age-related macular degeneration~     (AMD). The study also will generate new information on the relationship between genetics and~     GA progression. This is a global, prospective, multicenter, epidemiologic study enrolling 200~     participants with GA secondary to AMD. The study visits are scheduled to occur every 6~     months. The anticipated duration of the study is up to 60 months.~   "
89093|NCT02400931|"~     The mask ventilation is a necessary procedure to provide oxygenation before the tracheal~     intubation although the gastric insufflation occurs during the mask ventilation. Sugammadex,~     which is recently introduced, enables the use of high-dose muscle relaxant without concerning~     the delayed recovery of neuromuscular blockade. It seems that there is no need to perform the~     mask ventilation in adults with normal airway if the investigators use high-dose muscle~     relaxant for the anesthetic induction because adequate muscle relaxation can be achieved~     within 1-2 minutes. Therefore, the investigators hypothesized that routine mask ventilation~     is not needed in adult patients with normal airway. The investigators will compare the~     incidence of desaturation and gastric insufflation between the patients with mask ventilation~     and the patients without mask ventilation.~   "
89094|NCT02400918|"~     Social anxiety disorder (SAD) is the most common anxiety disorder, affecting up to 10% of the~     population and causing significant distress. Fortunately, there are effective interventions~     including cognitive behavior therapy (CBT) and acceptance and commitment therapy (ACT).~     However, only about a third of people with SAD seek treatment. There are a number of barriers~     to seeking treatment, including cost, availability, and stigma. Self-help may be one way to~     reach people who may not otherwise present for treatment. Research on self-help books for SAD~     based on CBT has yielded promising results. However, no research to date has examined the~     efficacy of ACT-based self-help for SAD. The primary purpose of the present study is to~     evaluate The Mindfulness and Acceptance-based Workbook for Social Anxiety and Shyness~     (Fleming & Kocovski, 2013), an ACT-based self-help book. Socially anxious participants will~     be randomly assigned to receive the workbook or be placed on a waitlist. It is hypothesized~     that workbook participants will report significantly reduced social anxiety at the end of~     eight weeks compared to waitlist participants. The secondary purpose is to evaluate how the~     treatment works. Increases in mindfulness and acceptance have been shown to lead to reduced~     social anxiety. These same variables will be examined in the present study. Finally, this~     research aims to examine variables that can predict who may do well in treatment. Given that~     two-thirds of people who meet criteria for this disorder will not seek traditional~     treatments, it is important to develop and evaluate alternative treatments, including those~     based on self-help.~   "
89095|NCT02400905|"~     To demonstrate that the BioMimics 3D Stent System meets the performance goals defined by VIVA~     Physicians, Inc. for the safety and effectiveness of Nitinol stents used in the treatment of~     symptomatic disease of the femoropopliteal artery. It is a prospective, single-arm,~     multicenter clinical trial.~   "
89096|NCT02400892|"~     This study will involve patients who are planned to have hip or knee replacement surgeries.~     They will undergo a Transthoracic Echocardiogram study (an ultrasound of the heart) to look~     for a Patent Foramen Ovale (PFO). A PFO is a hole in the heart that everyone is born with and~     in most cases eventually closes by adulthood. However, it does not always close in all~     people. The investigators will compare the participants as two groups - those with a PFO, and~     those without, and look for differences in delirium in their postoperative stay. This will~     help us look for an association between postoperative delirium and the presence of a PFO.~   "
89097|NCT02400879|"~     Background: Although remifentanil based anesthesia has been preferred for fast-track cardiac~     anesthesia, its recovery profile in cognitive function has not been investigated. Authors~     determined postoperative Bispectral index (BIS) score as well as extubation time after~     remifentanil-based propofol-supplemented anesthesia and compared them with those after~     conventional balanced sevoflurane-sufentanil anesthesia.~      Methods: Patients undergoing cardiac surgery using moderate hypothermic cardiopulmonary~     bypass (CPB) will be randomly allocated to get remifentanil-based propofol-supplemented~     (Group R) or conventional sevoflurane-sufentanil regimen (Group C) in the study period. For~     anesthetic induction and maintenance, fixed target controlled infusion (TCI) of remifentanil~     (plasma concentration 20 ng/ml) and TCI-propofol for maintaining BIS score 40-60 (effect~     concentration 0.8-1.5 μg/ml) in Group R, and TCI-sufentanil (Cp 0.4- 0.8 ng/ml) and~     sevoflurane inhalation for maintaining 80-120 % of baseline BP and BIS < 60 (< 1.5 MAC) in~     Group C, respectively.~      Authors will analyze postoperative recovery of cognitive function by using BIS after the use~     of remifentanil-based propofol-supplemented anesthesia for cardiac surgery and to compare~     them to those after the use of conventional balanced sevoflurane-sufentanil anesthesia.~   "
89098|NCT02400866|"~     This aim of study is to evaluate the safety and efficacy of olanzapine for the prevention of~     chemotherapy-induced nausea and vomiting in patients receiving moderately emetogenic~     chemotherapy by a randomized, double-blind, placebo-controlled trial.~   "
89099|NCT02400853|"~     The most frequent complications in premature infants are neurological complications:~     intracranial hemorrhages and white matter lesions. In Epipage 2 study the incidence of severe~     intraventricular hemorrhages remains stable. Severe hemorrhages are associated with~     neurological sequelae.~      A recent study in humans and in animals shows the role of the complex formed by plasminogen~     activator (t-PA) and its inhibitor (PAI-1) in the induction of vascular fragility via~     stromelysin (MMP-3). FIBRINAT study in Rouen University Hospital showed a rate of complex~     t-PA-PAI1 probably very high in preterm infants. An other factor maturation PDGF-C induced by~     t-PA is associated with the vascular embrittlement. Among the few genetic factors associated~     with cerebral palsy include 2 SNP of PAI-1 gene and one SNP in the gene of endothelial NO~     synthase.~      The hypothesis is that a high rate of the complex t-PA-PAI-1 in cord blood could be a high~     risk of intracranial hemorrhage in preterm infants and provide predictive of their~     occurrence. The rates of MMP-3, PDGF-C and PAI-1 free in cord blood, and the polymorphism of~     PAI-1 gene and eNOS could separately or associated with the main criterion to identify~     predictive of hemorrhages.~      The main objective is to search a rate difference of the complex t-PA-PAI-1 in cord blood of~     preterm infants (before 30 weeks of gestation) that would predict intracranial hemorrhage~     coming in the first days of life.~      The secondary objectives are~        -  Evaluate potential marker risk of high levels of MMP-3, PAI-1 free, and PDGF-CC~        -  Search in both groups the presence of alleles -675G4 / G5 and 11053 (G / T) of the PAI-1~          gene and -922 (A / G) of the eNOS gene.~           120 preterm infants will be included before 30 weeks of gestation with precise inclusion~          and exclusion criteria during a period of 3 years.~      Patients will be divided into two groups according to whether they will or not showed~     intracranial hemorrhage (detected by ultrasound J5-J7).~      The complex rate tPA-PAI-1, PAI-1 free, MMP-3 and PDGF-C will be measured. The comparison~     between the two groups will be carried out using statistical tests. Comparison of the~     presence of the alleles -675 4G and 11053T the PAI-1 gene or -922G eNOS gene between the two~     groups will be performed.~      The demonstration of this hypothesis would permit to identify children from birth in whom the~     immediate implementation of preventive treatment of bleeding is desirable.~   "
89100|NCT02400840|"~     Acute heart allograft rejection is a common complication after orthotopic heart~     transplantation. Primary objective of this study is to assess cardiac MRI as a tool for acute~     heart graft rejection screening, by detecting changes in myocardium structure especially~     extracellular volume.~   "
89237|NCT02399059|"~     Antibiotic lavage reduces bacterial contamination and decreases SSI infection rate. SSI leads~     to an immunocompromised situation, leaving unattended the neoplasm. It has been described~     that SSI may result in a worse oncologic outcome.~   "
89102|NCT02400814|"~     This pilot phase I trial compares administration schedules of anti-programmed cell death-1~     ligand 1 (PD-L1) monoclonal antibody MPDL3280A and stereotactic ablative radiotherapy in~     treating patients with stage IV non-small cell lung cancer. Monoclonal antibodies, such as~     anti-PD-L1 monoclonal antibody MPDL3280A, may block tumor growth in different ways by~     targeting certain cells. Stereotactic ablative radiotherapy, also known as stereotactic body~     radiation therapy, is a specialized radiation therapy that delivers a single, high dose of~     radiation directly to the tumor and may kill more tumor cells and cause less damage to normal~     tissue. Giving anti-PD-L1 monoclonal antibody MPDL3280A with stereotactic ablative~     radiotherapy may be a better treatment for non-small cell lung cancer. However, it is not yet~     known what the best administration schedule is for these treatments.~   "
89103|NCT02400801|"~     Does prolonged GnRH downregulation prior to ART improve the clinical pregnancy rate in~     postoperative endometriosis patients? (A single centre randomised controlled trial)~   "
89104|NCT02400788|"~     The purpose of this study is to assess efficacy and safety in combination of resminostat and~     sorafenib in Asian patients with advanced HCC previously untreated with systemic~     chemotherapy.~   "
89105|NCT02400775|"~     The purpose of this study is to evaluate the effects of oral azilsartan once daily for 32~     weeks on coronary artery plaque in essential hypertensive patients with stable angina and~     dyslipidemia.~   "
89106|NCT02400762|"~     The purpose of this study is to collect on-label safety and efficacy data where InQu Bone~     Graft Extender is applied to transforaminal lumbar interbody fusion (TLIF) and posterior~     lumbar interbody fusion (PLIF).~      It is expected that this study will contribute to the compilation of clinical data required~     to demonstrate the ability of InQu to promote safe, effective and timely spine fusion in~     patients who undergo PLIF or TLIF surgery. The results of this study will lead to further~     analysis (i.e. comparison to historical data of other marketed bone graft products, as well~     as, to local bone alone).~   "
89107|NCT02400749|"~     This study will compare the safety and efficacy of Apremilast 30mg to placebo in subjects~     with moderate to severe plaque psoriasis involving palms and/or soles.~      Apremilast will be administered orally twice daily for 16 to 32 weeks, and will be compared~     against placebo (dummy drug with no active ingredient).~      This study will enroll approximately 100 adult subjects with moderate to severe plaque~     psoriasis involving palms and/or soles in approximately 20 centers in US and Canada. To be~     eligible, subjects must have moderate to severe plaque psoriasis involving palms or soles,~     with lesions covering at least 10% of the surface of palms and soles at the baseline visit.~     Study treatments will be assigned randomly (like flipping a coin) at a 1:1 ratio, meaning~     that there will be a 1 in 2 chance of either receiving Apremilast or placebo during the first~     16 weeks. Subjects will not know which of the two treatments they receive. The study doctor,~     the study staff will not know which treatment they receive either. All subjects will receive~     Apremilast from Week 16 to Week 32.~      Subjects will be asked to complete questionnaires about their hand and feet pain, their~     quality of life, their general health and the impact of psoriasis on their work.~      Medical photographs of palms and soles will be taken for subjects at selected study sites~     only.~      At Baseline and Week 16 visits, for willing subjects at certain study sites, skin biopsies~     can be taken. The biopsies will be analyzed for the presence of antibodies, antigens or~     certain cellular messengers that can be quantified. It is also possible to study the skin~     cellular structure and organization.~      A total of 3 biopsies will be taken: At Baseline visit, one biopsy from psoriasis on palms or~     soles and one biopsy from normal skin of palms or soles will be collected. At Week 16 visit,~     only one biopsy from psoriasis on palms or soles will be collected.~   "
89108|NCT02400736|"~     In response to the Rehabilitation Research and Development (RR&D) Deployment Health Research,~     this study addresses the delivery of an evidenced-based vocational rehabilitation,~     specifically Individual Placement and Support (IPS), for Veterans who often face unemployment~     and mental illness as they try to recovery from illness and re-establish civilian life. This~     study provides the requisite evidence needed to guide VHA as to whether to expand the target~     population for IPS to all Veterans with a mental disorder, delivered directly within the~     primary care setting (i.e. Patient Aligned Care Team; PACT). Such modifications in VHA~     practice could substantially improve Veteran vocational rehabilitation access and outcomes,~     moving a significantly greater number of disabled Veterans back to full and productive lives~     in the community.~   "
89109|NCT02400723|"~     Anxiety leads to poor quality of life, avoidance of activities, decreased social engagement,~     functional decline, and disability in older patients. This study will compare two~     self-directed treatments delivered via DVD videos that can be viewed in one's own home. The~     two treatments being compared are: psychoeducation, which refers to information and education~     about anxiety, and a behavioral treatment program, called BREATHE (Breathing, Relaxation and~     Education for Anxiety Treatment in the Home Environment). BREATHE teaches diaphragmatic~     breathing and progressive muscle relaxation. Participants will be randomly assigned to either~     treatment. The study is 12 weeks long. There are 4 weeks of treatment via DVD and 8 weeks of~     follow-up. Participants will be asked questions about anxiety symptoms, mood, health and~     functioning.~   "
89110|NCT02400710|"~     PTSD Coach is a mobile application (app) that aims to teach individuals self-management~     strategies for symptoms of Post-traumatic Stress Disorder (PTSD). Despite PTSD Coach's use of~     evidence-based cognitive behavioral strategies there is still a need to test the~     effectiveness of the app in managing PTSD symptoms. There is research evidence that~     self-management programs are often underutilized, but that clinician contact can increase~     patient involvement. The addition of clinician support may enhance the utilization and~     effectiveness of the PTSD Coach. In Phase 1 the investigators propose to conduct stakeholder~     interviews with primary care (PC) and mental health (MH) leadership staff to investigate~     barriers and facilitators to implementing Clinician-Supported (CS-PTSD Coach) to increase the~     uptake, use, and impact of PTSD Coach by PC patients. The interviews will inform the~     development of a CS-PTSD Coach protocol and manual that will be used in phase 2. In phase 2~     the investigators propose to conduct a feasibility study where 30 (20 eligible) PC Veterans~     with diagnostic-level or subthreshold PTSD symptoms will be randomized to receive~     Self-Managed (SM) PTSD Coach or CS-PTSD Coach. The investigators' specific aims are to 1)~     investigate the feasibility of recruiting and retaining participants and delivering the SM~     and CS conditions and 2) conduct a preliminary investigation of the efficacy of SM vs. CS.~     The investigators predict that CS will lead to greater treatment gains than SM. Effect sizes~     will be generated for the following outcomes: a) reductions in PTSD, depression, and general~     distress, and increases in health-related functioning, b) increases in knowledge about PTSD~     symptoms, PTSD management strategies, and patient coping self-efficacy, c) increases in~     initiation of tradition PTSD treatments.~   "
89238|NCT02399046|"~     A clinical trial of total knee system used in Primary Total Knee Arthroplasty in China.~   "
89272|NCT02398604|"~     This study is intended to evaluate the safety and feasibility of intramyocardial injection of~     allogeneic mesenchymal cells during the Bi-Directional Cavopulmonary Anastomosis (BDCPA)~     surgery for hypoplastic left heart syndrome (HLHS) pediatric patients.~   "
89112|NCT02400684|"~     Endometriosis is the ectopic implantation of endometrial glands and stroma, and can be~     ovarian and peritoneal (superficial or deep). There are 4 stages in endometriosis according~     to severity, and the stage is established on the basis of intra-operative observations. The~     AFSr classification is currently most used (I-IV,minimal, mild, moderate, severe). Most~     associated with endometriosis are subfertility and pelvic pain.~      In the surgical management of deep endometriosis, the issue of fertility is pivotal. There is~     a higher rate of infertility in a population of women with endometriosis as compared to the~     general population, even though the mechanisms are not yet elucidated. Patients with deep~     endometriosis can be referred to the surgeon for subfertility, but even when they are~     referred for chronic pain, future fertility considerations are taken into account in the~     planning of the surgery, as the patients are often young.~      It is now well documented that ovarian cystectomy is deleterious with regards to the ovarian~     reserve, and more so in endometriomas than in any other type of benign cysts. The ovarian~     reserve is the functional potential of the ovaries, reflecting the quantity and quality of~     remaining follicles. Studies have also relied greatly on the measure of serum anti-mullerian~     hormone (AMH) to evaluate the effect of cystectomy on ovarian reserve, as AMH is currently~     the most reliable marker to assess ovarian reserve. A significant difference was found~     between AMH before and following cystectomy in several studies. The deleterious effect of~     deep endometriosis surgery which comprises a wide dissection and adhesiolysis of the pelvis~     in many cases, even when no cystectomy has been performed, is therefore not entirely ruled~     out. To the best of our knowledge, there are no studies on the effect of deep endometriosis~     surgery, apart from ovarian surgery, on ovarian reserve.~      Our center is very active in the laparoscopic surgical treatment of deep endometriosis, with~     more than 200 cases every year. The objective of this trial is to assess the effect of deep~     endometriosis surgery on the ovarian reserve, whether a cystectomy is performed or not, by~     measuring serum AMH before and after surgery, at 6 months and 1 year post-operatively.~   "
89113|NCT02400671|"~     The investigators are conducting a 3-arm randomized trial comparing the effects of~     unidirectional SMS (ie: push messaging to participant) vs. bidirectional SMS dialogue~     between participant and provider vs. control (no SMS) among HIV-infected Kenyan mothers in~     Kenyan PMTCT-ART for outcomes of ART adherence and retention in care.~   "
89114|NCT02400658|"~     The purpose of this study is to evaluate an investigational way to provide radiation therapy~     to treat early-stage breast cancer at the time of surgery.~   "
89115|NCT02400645|"~     In this randomized, controlled, double-blinded trial we plan to evaluate post-operative pain~     relief after laparoscopic-assisted Transversus Abdominis Plane (TAP) block using liposomal~     bupivacaine plus bupivacaine versus pre-incisional would infiltration with bupivacaine in~     patients undergoing Total laparoscopic or robotic assisted laparoscopic hysterectomy.~   "
89116|NCT02400632|"~     The purpose of this study is to demonstrate the efficacy of MagicTouch DCB in reducing late~     lumen loss / suppressing neointimal tissue formation as assessed by Quantitative Coronary~     Angiography / Intravascular Ultrasound examination for the treatment of coronary artery~     lesions ranging from 3.0 mm to 3.5 mm of diameter and lesion length ≤ 15 mm.~   "
89117|NCT02400619|"~     Spasticity is a motor disorder that can affect the lower limbs in up to 75% patients with~     cerebral palsy, having a significantly effect on their mobility and quality of life. There is~     much controversy about what is the most appropriate treatment of spasticity The objective of~     the present study is to evaluate the effects of radial extracorporeal shock wave therapy~     (rESWT) compared to treatment with botulinum toxin to improve spasticity in patients with~     cerebral palsy~      The number needed of patients is 70 (35 per group). Leaving a period of washout between one~     therapy and the other~   "
89118|NCT02400606|"~     The aim of the study was to explore the effect of actively constructing Virtual patient (VP)~     cases compared with solving VP cases using 'Web-SP', Stockholm University, Stockholm, Sweden~     on knowledge gains and skills transfer in a group of pre-clerkship medical students.~   "
89119|NCT02400593|"~     Growing up in a low-income household has been shown to increase risk for, and susceptibility~     to many illnesses.The purpose of the study is to test an affective intervention for reversing~     biological risk factors, as related to childhood adversity, in midlife.~      Participants will be asked to make two lab visits; attend six weekly, 1-hour meditation~     classes; as well as complete brief online daily surveys for 11 weeks, five biweekly surveys,~     and two 30-minute surveys prior to each lab visit. During the lab visits, participants will~     have their psychophysiology monitored for heart rate, blood pressure, respiration, and pulse.~     Participants will also have their blood drawn.~      All surveys and questionnaires inquire about participants' current demographics, family~     history, perceptions about life and well-being, physical health, and monetary choices.~   "
89120|NCT02400580|"~     The objective of this study is to quantify the change in post-operative pain scores and~     narcotic requirements in women receiving pre and post-operative IV acetaminophen compared to~     placebo in women undergoing laparoscopic hysterectomy.~   "
89121|NCT02400567|"~     The investigators propose in the present study an innovative approach, combining the most~     recent therapeutic opportunities in high risk ER+ breast cancer with the most recent and~     innovative diagnostic approaches such as the PAM50 signature and the RCB tumor response~     evaluation method. In line with the most recent recommendations on targeted anticancer~     therapies, the investigators have designed a parallel phase II randomized trial with early~     stopping rules 26, which will able in the meantime to build a unique prospective collection~     of tumor tissue, pre- and post-treatment.~   "
89122|NCT02400554|"~     This is an obesity and alcohol, tobacco, and other drug (ATOD) use risk prevention and health~     leadership program. This project will include 150 at-risk adult Native women across 5~     communities (30 women from each community) in the Choctaw Nation of Oklahoma. The~     intervention targets individual behavioral change relative to ATOD and obesity prevention and~     simultaneously provides behavioral skills for health promotion leadership.~      Investigators will conduct a longitudinal study using a cluster randomized stepped-wedge~     design to evaluate the intervention impact on ATOD and obesity prevention primary aims of:~     (1) substance use harm reduction and ATOD use and intentions to use; and (2) reduction in~     weight/body mass index (BMI) and increase in leisure-time physical activity/physical activity~     (LTPA/PA) and healthful food habits. Specifically, investigators will ask participants to~     participate in up to eight group sessions (based on a curriculum drawing on cultural~     teachings around health and behavioral change); attend up to three Motivational Interviewing~     individual sessions (to identify individual behavioral change goals); attend a two-day~     overnight culture and Trail prep camp; participate in camping and walking for up to 10 days~     on the Trail; and attend up to six post-walk meetings (to develop community health events).~     All five communities will also be asked to complete a baseline health assessment as well as~     three follow up assessments over the course of the year. Additionally, communities 2-5 will~     participate in three pre-intervention health assessments. This intervention integrates~     components of motivational interviewing, information-motivation-behavior, and a leadership~     development framework for adults. It targets individual behavioral change relative to ATOD~     and obesity prevention and simultaneously provides behavioral skills for health promotion~     leadership within their respective communities.The project addresses a critical public health~     issue among a group experiencing considerable health disparities and strengthens the research~     infrastructure in partnership with the Tribe. If efficacious, it has the potential for~     widespread dissemination and could be generalizable to other chronic co-occurring mental~     health and physical health conditions.~   "
89123|NCT02400541|"~     The aim of research is to test in a randomized clinical trial with active sessions, the~     efficacy of cognitive remediation therapy in children anorexia nervosa compared to a~     controlled group. The investigators want to confirm the efficacy of cognitive remediation~     treatment in children's flexibility problems.~   "
89124|NCT02400528|"~     The studies conducted so far concerning the medical and paramedical cares provided to~     patients with profound and multiple disabilities (PMD) often show important limitations:~     samples are too small or very heterogeneous, generally constituted of children only; studies~     are mainly cross-sectional and retrospective, focusing on very specific issues instead of~     assessing health and quality of life from a more global perspective… So far, the~     investigators found no published data from a prospective cohort study involving a~     representative sample of patients with PMD. The present project aims to set up such a cohort~     so as to describe for the first time the natural history of French patients with PMD as well~     as the cares they receive at home or within the different dedicated structures in France.~     This cohort will also make it possible to identify the factors responsible for differences in~     the cares patients are provided, the consequences of these differences on their health and~     their quality of life (and those of their relatives) as well as the evolutions of these data~     over time. It will then allow for assessing the effectiveness of the French healthcare system~     to care for patients with PMD as well as building a frame of reference regarding the best~     cares to provide to these patients.~      The primary goal of this study is to identify the determinants of health among patients with~     PMD.~   "
89125|NCT02400515|"~     This quasi-experimental study aim to evaluate the effect of moderate aerobic exercise on~     glucose and lipid metabolism as well as the scales of anxiety and depression and levels of~     salivary cortisol in women with type 2 diabetes.~   "
89126|NCT02400502|"~     Integrated Coping and Awareness Therapy is a novel therapeutic intervention combining~     strategies to improve stress reactivity and increase meaningful coping, as well as a range of~     possible proximal (e.g. immune indices of stress reactivity, symptom severity) and distal~     measures (e.g. relapse, quality of life).~   "
89127|NCT02400489|"~     To recruit patients who implanted with Perimount Heart Valve (Type Number: 6900PTFX or~     2800TFX) from three hospitals in China.~      To track the patients'situations during one year after surgery and to collect the relevant~     clinical data.~   "
89128|NCT02400476|"~     An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients with~     Early-Stage HER2+ Breast Cancer Treated with Neratinib and Intensive Loperamide Prophylaxis~   "
89129|NCT02400463|"~     This is a pilot study to determine the efficacy of Ruxolitinib in secondary hemophagocytic~     syndrome. The primary objective is to assess the efficacy of ruxolitinib 15 mg PO twice daily~     in patients with HPS. The primary endpoint is overall survival at two months.~   "
89130|NCT02400450|"~     This is a multi-site, double-blind, randomized, controlled food intervention study being~     conducted at the Canadian Centre for Agri-Food Research in Health and Medicine (CCARM) in~     Winnipeg and the Mayo Clinic, Rochester, MN, to examine the effects of a portfolio of~     functional foods on blood glucose and lipids, and blood vessel function in individuals with~     prediabetes.~      A total of 116 participants (n=58/site) with prediabetes (hemoglobin A1c ≥6.0 & <7.0 and no~     glucose-lowering medications) and body-mass index (BMI) 18-40 will be recruited for a 12-week~     clinical trial to determine the effect of eating 2 items containing functional ingredients~     daily compared to 2 similar items lacking the functional ingredients. Study foods provided~     are to be incorporated into participant's usual diet.~   "
89131|NCT02400437|"~     This research study is evaluating a drug called ixazomib (also known as MLN9708) in~     combination with dexamethasone and rituximab (the regimen is called IDR) as a possible~     treatment for Waldenstrom's Macroglobulinemia (WM).~   "
89132|NCT02400424|"~     The purpose of this study is to evaluate the efficacy of stereotactic lung radiation therapy~     after concomitant radiochemotherapy for unresectable stage III non-small cell lung carcinoma~     (NSCLC) with peripheral primary tumor.~      Evaluate in terms of local control rate at 6 months the addition of stereotactic radiotherapy~     after concurrent chemoradiotherapy in the treatment of mediastinal non-resectable stage III~     NSCLC having a peripheral primary tumor.~      The number of patients required in this multicenter prospective study is 70.~      This is a prospective, multicenter, non comparative and non randomized study.~   "
89133|NCT02400411|"~     This is a postprandial study with healthy volunteers. The glycemic and insulinemic responses~     elicited by meals containing either whole grain rye bread or white wheat bread as such or~     combined with margarine and ham and vegetable soup are compared. Blood glucose concentrations~     are monitored from finger prick blood samples collected before the meal and at 15, 30, 45,~     60, 90 and 120 min. Venous samples for insulin concentrations are taken at time-points 0, 30~     and 60 min.~   "
89134|NCT02400398|"~     Eligible patients will have a diagnosis of both pancreatic adenocarcinoma and cachexia~     defined as greater than 5% unintentional weight loss within 6 months prior to screening~     visit. Patients must be greater than 18 years of age; and have greater than 3 months life~     expectancy.~      This study will observe a standard of care intervention (tube feeding) for potential benefit.~     Peptamen will be administered through a jejunal or a gastrojejunal feeding tube and dosing~     will be calculated using the Mifflin St. Jeor equation. It will be administered daily for the~     duration of the protocol.~   "
89135|NCT02400385|"~     This will be a phase II trial of the combination of sunitinib and nivolumab in patients with~     advanced, measurable, metastatic melanoma who harbor mutations in the KIT gene in their~     tumors. It is a multi-center trial using the FDA-approved doses of both sunitinib and~     nivolumab. Sunitinib will be provided by Pfizer. Endpoint is RECIST response rate and PFS.~   "
89158|NCT02400086|"~     Patients with neurological or neuromuscular diseases may need a long-term tracheostomy to~     improve their respiratory function. Bacterial flora and bacterial drug resistance in the~     respiratory tract have never been studied until then for this type of patient in spite of~     their frequent hospital stay, their regular exposition to antibiotics and their~     susceptibility to swallowing disorders due to their pathology. This study is based on a~     single tracheal aspirate within the 48 first hours of the patient stay for a ventilation~     check up beside any infectious context to describe the basal bacterial respiratory flora.~   "
89248|NCT02398916|"~     Loop electrosurgical excision procedure (LEEP) is the primary diagnostic and therapeutic~     procedure employed in women with high-grade intraepithelial neoplasia of the cervix. The~     procedure usually performed in the outpatient setting under local anesthesia. However, it~     could be associated with significant pain and anxiety.~      The aim of this study is to examine the effects of listening to music during the procedure in~     reducing pain and anxiety.~   "
89136|NCT02400372|"~     The study, Evaluation of the effect of antibacterial medical honey dressing for healing of~     implants donor area, is a Phase 4 Study, Prospective, A randomized trial, 3 arms (treatment~     groups) trial, Open-label, non-controlled, non-randomized, Aims To test the effectiveness of~     antibacterial medical honey dressing in the therapy of donor area of implants. In our~     Research Will participate in 135 new patients over the age of 18, with a wound in the donor~     area of hip implants, Hospitalized in the Plastic Surgery Unit of the Haemek Medical~     Center. Appropriate patients, who will agree to sign and sign a consent form, be assigned~     randomly to one of three treatment groups:~        1. The research group: Medihoney antibacterial wound dressing.~        2. The control group: Paraffin gauze with saline- The basic treatment in the donor site,~          accepted the literature.~        3. Comparison group: Polymem dressing - Common treatment in the donor site in the Plastic~          Surgery Unit of the Haemek Medical Center.~      Participants in the three study groups will be performed, each visit, Medical monitoring and~     examination by a team of medical indices of Plastic Surgery Unit, as is customary. The~     treatment will be performed, twice a week until recovery and the complete closure of the~     wound.~   "
89137|NCT02400359|"~     The purpose of this protocol is to investigate, using functional magnetic resonance imaging~     (fMRI), the effect of treatment with lorcaserin on centers of the brain that control appetite~     and food intake, as well as lorcaserin's downstream metabolic effects.~   "
89138|NCT02400346|"~     The purpose of this study is to evaluate the safety and tolerability of brexpiprazole as~     adjunctive treatment in an elderly population with major depressive disorder and an~     inadequate response to antidepressant treatment~   "
89139|NCT02400333|"~     This study will be an open-label, randomised, four-period, four-treatment, crossover study in~     healthy male and female of non-childbearing potential subjects, performed at a single study~     centre.~      The objective of the study is to assess the bioavailability of ticagrelor orodispersible (OD)~     tablets when administered with water, without water and suspended in water to be administered~     through nasogastric tubes, compared to ticagrelor immediate-release (IR) tablets~   "
89140|NCT02400320|"~     The purpose of this study is to determine local skin safety of a topical analgesic spray~     containing a combination of diclofenac, methyl salicylate, menthol and compare it with a~     topical analgesic gel containing a combination of diclofenac, methyl salicylate, and menthol.~   "
89141|NCT02400307|"~     This study will evaluate the pharmacokinetic (PK) profile, safety, and tolerability of oral~     GS-9883 in adults with impaired renal function relative to matched, healthy controls with~     normal renal function. Each participant in the renal impairment groups will be matched for~     age (± 10 years), gender, and body mass index [BMI (± 20%, 18 ≤ BMI ≤ 40 kg/m^2)] with a~     participant in the control group.~   "
89142|NCT02400294|"~     Effect of toothbrushing in oral care of mechanically ventilated critically ill patients on~     prevention of ventilator associated pneumonia~   "
89143|NCT02400281|"~     This is an open label, two-arm, Phase I-II trial, non-randomized. Arm 1: crenolanib with~     standard chemotherapy (Idarubicin/Cytarabine, MEC;Mitoxantrone/Etoposide/Cytarabine,~     FLAG-Ida: Fludarabine/Cytarabine/G-CSF/Idarubicin) Arm 2: crenolanib with 5-azacitidine~   "
89144|NCT02400268|"~     The antimicrobial crisis is a real problem. Infections produced by multiresistant bacteria~     are becoming more and more frequent, and available antimicrobial agents are usually scarce.~     Reducing the duration of antimicrobial treatments is one of the most efficient measures to~     control the antibiotic pressure and to optimise the use of these agents.~      Bloodstream infections produced by Enterobacteria (EB) are very frequent, but the optimal~     duration of antibiotics to treat them is unknown, as long as no clinical trials have been~     specifically developed to answer this question.~      Basing on expert opinions, the Infectious Diseases Society pf America (IDSA) recommends the~     bacteremia by EB secondary to vascular catheter infections to be treated for 7 to 14 days.~     This represents a variability of up to 100%. No recommendations have been published regarding~     the duration of treatment of bacteremia from other sources.~      The objective of this project is to prove that the 7-day course of treatment for EB~     bacteremia is more efficient and equally safe than the 14-day scheme.~   "
89145|NCT02400255|"~     This is a single-arm, Phase II study of crenolanib as maintenance in AML patients with FLT3~     mutations who have achieved complete remission (CR) after allogeneic stem cell~     transplantation. Oral crenolanib will be administered daily post-transplant for up to two~     years.~   "
89146|NCT02400242|"~     This is a phase 1a/1b, multicenter, single-arm, open-label, dose escalation study to~     determine the maximum tolerated dose (MTD) and evaluate the safety and preliminary antitumor~     activity of ACY-241 for oral administration as monotherapy and in combination therapy with~     orally administered pomalidomide and low-dose dexamethasone in eligible patients with~     relapsed or relapsed-and-refractory multiple myeloma (MM).~   "
89147|NCT02400229|"~     The primary hypothesis is that computertomography (CT) is superior to invasive coronary~     angiography (ICA) concerning the primary endpoint MACE (MACE = major adverse cardiovascular~     event; defined as at least one of the following: cardiovascular death, nonfatal myocardial~     infarction, and nonfatal stroke) after a maximum follow-up of 4 years, in other words, that~     CT will result in a significantly lower rate of MACE. Secondary outcomes include MICE (MICE =~     minor cardiovascular events), procedural complications, cost-effectiveness, radiation~     exposure, cross-over to CT or ICA, gender differences, and health-related quality of life.~   "
89159|NCT02400073|"~     Obstructive sleep apnea (OSA) has detrimental effects on the health and quality of life of~     suffers. Recent literature has shown that females may be particularly susceptible to adverse~     the quality of life effects, and that female obstructive sleep apnea manifests differently~     than male obstructive sleep apnea. A new AutoSetting Positive Airway Pressure (PAP) device~     has been designed specifically to treat female OSA. In this Cohort study, female patients who~     are newly diagnosed with OSA will be asked to complete various questionnaires relating to~     their quality of life. Patients will then use the AutoSet for Her for three months. At the~     completion of the three months the questionnaires will be repeated. Before treatment and~     after treatment quality of life will be compared to determine if treating female specific OSA~     in these patients improves quality of life.~   "
89273|NCT02398591|"~     The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of~     three dosages (250, 500, and 1000 milligram [mg], or maximum tolerated dose [MTD]) of JNJ~     53718678 when administered as single dose in fasting conditions in healthy Japanese adult~     participants in 3 cohorts.~   "
89148|NCT02400216|"~     Background:~      - Hepatitis C infection (HCV) is a leading cause of liver disease. Normal bacteria from the~     intestines may spread to the liver and blood during liver disease. This is called bacterial~     translocation (BT). Researchers think BT may cause liver disease to worsen.~      Objectives:~      - To study the mechanisms involved in BT in early and advanced liver disease. To find out~     whether BT causes liver disease to worsen.~      Eligibility:~      - People over age 18 with HCV and clinically stable liver disease.~      Design:~        -  Participants will be screened with medical history and physical exam. They will have~          blood tests and imaging studies.~        -  Participants will have 2 outpatient visits and a 3-day stay at the clinic.~        -  At visit 1, participants will have urine and blood tests. They will have a magnetic~          resonance imaging (MRI) scan. A solution will be injected into a vein. The MRI scanner~          is a metal cylinder surrounded by a magnetic field. The participant will lie on a table~          that slides in and out of the cylinder.~        -  At visit 2, a substance will be injected into a vein and swallowed. Participants will~          then have blood drawn 5 times over 90 minutes.~        -  During the inpatient stay, serial blood tests will be drawn.~        -  Participants will give 2 stool samples and have another MRI.~        -  A needle will be inserted through the chest wall into a vein inside the liver, guided by~          ultrasound. The blood pressure inside this vein will be measured and blood will be drawn~          from it. About 1 inch of liver tissue will be removed.~        -  A study investigator will call participants to discuss all test results.~   "
89149|NCT02400203|"~     The objectives of this trial are to assess the effects of hemp product consumption,~     specifically hulled hemp seeds and hemp oil on blood fatty acid profiles and cardiovascular~     disease risk factors, in healthy overweight volunteers after 4 weeks of consumption.~   "
89150|NCT02400190|"~     This study will collect rates of local/regional recurrence in select patients who do not~     receive radiation treatment after lumpectomy surgery. These women must be postmenopausal;~     have hormone receptor-positive, Her2-negative tumors; have Oncotype-DX RS less than or equal~     to 18; and plan to receive endocrine therapy. In this way, this study seeks to collect~     prospective data supporting the idea that this is a population at sufficiently low risk of~     local/regional recurrence that omission of adjuvant radiation might be a reasonable option.~   "
89151|NCT02400177|"~     The purpose of this study is examine emotional regulation and reflective functioning in~     parents of children with Autism Spectrum Disorders (ASD) before and after an educational~     training (four sessions workshop). Our experimental aims are the following: 1) examine~     parental emotion regulation and reflective functioning in daily life, 2) examine children~     emotion regulation in their daily life 3)Learn about the training efficacy for ASD parents.~     This research study will help to formulate innovative treatment methods to reinforce positive~     emotion regulation of both ASD children and their parents.~   "
89152|NCT02400164|"~     The study is a multi-center, prospective, open label, uncontrolled feasibility study~     enrolling 30 patients with refractory or recurrent ascites and cirrhosis at up to 6 sites.~     Patients will be enrolled during a 6 month enrollment phase after which data will be~     collected for 12months with an initial analysis after 3 months. Extended follow-up for safety~     monitoring purposes will continue for the lifetime of the patient or until the device is~     explanted.~   "
89153|NCT02400151|"~     The main objective of this study is to analyze in a population of obese adolescents, the~     effect of vitamin D3 supplementation in addition to lifestyle and dietary management on~     vascular function assessed by the change between M0 and M3 of endothelium-dependent~     vasorelaxation measured at the brachial artery (Flow-Mediated Dilation).~   "
89154|NCT02400138|"~     Weakness of the respiratory muscles demonstrated by individuals with stroke, may generate~     important symptoms, such as fatigue and dyspnea. Since adequate strength of the inspiratory~     and expiratory muscles is required, mainly when performing physical activities,~     rehabilitation interventions for stroke subjects should include respiratory training. This~     study will test the hypothesis that home-based combined training of the inspiratory and~     expiratory muscles is effective in improving strength of the inspiratory and expiratory~     muscles, endurance of the inspiratory muscles, dyspnea, walking capacity, and ocurrence of~     respiratory complications after stroke. For this clinical trial, people after stroke will be~     randomly allocated into either experimental or control/sham groups. The experimental group~     will undertake training of the inspiratory plus expiratory muscles with the Orygen Dual Valve~     device, regulated at 50% of the subjects' maximal inspiratory and expíratory pressure values,~     seven times/week over eight weeks during 40 minutes/day. The control group will undertake the~     same protocol, but the participants will receive the devices without resistance. At baseline,~     post intervention, and four weeks after the cessation of the intervention, researchers~     blinded to group allocations will collect the following outcome measures: maximal inspiratory~     and expiratory pressures, inspiratory endurance, dyspnea, walking capacity, and ocurrence of~     respiratory complications.~   "
89155|NCT02400125|"~     China Cardiovascular Surgery Registry (CCSR) Study is a national database for coronary artery~     bypass grafting (CABG) and valve surgery performed in 87 hospitals with cardiovascular~     surgery volume > 100 per year. The aims of CCSR Study are: (i) report the characteristics of~     patient, the quality and evolvement of CABG and valve procedures in China, (ii) build and~     valid surgical risk assessment tools for Chinese population, (iii) provide databases for~     clinical studies, and quality improvement initiatives.~   "
89156|NCT02400112|"~     The purpose of this study is to determine if local administration of vancomycin powder at the~     site of Grade I-IIIA open fractures at the time of surgery will be an efficacious method to~     lower infection rates in open fracture treatment and to elucidate any detrimental effects of~     applying vancomycin powder at the site of open fractures.~   "
89157|NCT02400099|"~     Randomized, single-blind, trial to determine whether a high-protein, low calorie diet is more~     effective than a control low calorie diet in improving the metabolic and histologic~     abnormalities in patients with Non-alcoholic Fatty Liver Disease undergoing bariatric~     surgery.~   "
89160|NCT02400060|"~     This pilot trial studies a telephone-based intervention to see if it increases adherence to~     adjuvant hormonal therapy in patients with breast cancer. Increasing communication between~     doctors and patients with breast cancer may help patients to better follow recommendations on~     taking adjuvant hormonal treatment medication. A telephone-based intervention may help to~     increase doctor-patient communication and patients' adherence to their prescribed medication.~   "
89161|NCT02400047|"~     Postoperative pain and nausea-vomiting (PONV) are the first causes of failure in ambulatory~     care in pediatric surgery. Actually, the paracetamol/ketoprofen combination in intraoperative~     care is recommended for effective postoperative analgesia in children. However, intravenous~     ketoprofen doesn't have the marketing authorization for use in children less than 15 years~     old and its use is mainly justified by the absence of therapeutic alternatives. Recently,~     findings from published studies suggest that dexamethasone (DXM), which is actually~     recommended to prevent PONV for children at risk, at a dose of 0.1mg/kg, would have~     analgesic properties above 0.15 mg/kg comparable to non-steroidal anti-inflammatories (NSAI).~      Main objective :~      To examine the effects of intraoperative DXM (0.2mg/kg and 0.4mg/kg) on the intensity of~     postoperative pain in the post-anaesthetic care unit (PACU) compared to ketoprofen (1mg/kg).~      Secondary objectives :~      To examine the effects of intraoperative DXM (0.2mg/kg and 0.4mg/kg) compared to ketoprofen~     (1mg/kg) on the anesthesia emergence delirium, the intensity of postoperative pain, the~     consumption of rescue analgesics and the side effects in the first 24 hours after surgery.~   "
89162|NCT02400034|"~     Urinary incontinence is a prevalent health and quality of life concern affecting almost half~     of women over the age of 20. Urinary retention (abnormal holding of urine) is a concern of~     many surgeons who perform midurethral sling surgery. All patients after outpatient~     midurethral sling or vaginal prolpase surgery must complete a voiding trial if they are to be~     discharged without a catheter. The purpose of this study is to compare two different types of~     postoperative voiding trials to determine which leads to less post-operative issues, such as~     urinary retention requiring catheterization. You are being asked to participate because you~     are having midurethral sling surgery, either with or without vaginal prolapse repair.~   "
89163|NCT02400021|"~     In pregnancy, cART is considered optimal for maternal health and for preventing the emergence~     of resistance that could compromise further care. In Canada, the majority of HIV-positive~     pregnant women receive a PI-based cART regimen. In the past, therapy was generally deferred~     until after the first trimester (if not required for maternal health) to minimize any unknown~     risk of teratogenicity. However, as treatment is now started earlier in HIV infection and as~     perinatal transmission rates are lowest in those with prolonged suppression of viral load~     during pregnancy, women are increasingly commencing cART either before conception or earlier~     in pregnancy.~      Multiple reports and cohort studies provided data suggesting an association between PI-based~     cART use and preterm birth, low birth weight, and small for gestational age (SGA) babies,~     although conflicting data exist.~      In the general population progesterone supplementation is widely used, is well tolerated, is~     considered safe, and is beneficial to prevent recurrent pre-term birth and increase birth~     weight. The investigators experimental findings suggest that PI use during pregnancy is~     associated with declines in progesterone levels that correlate with fetal growth, and that~     progesterone supplementation can improve PI-induced fetal growth restriction. The~     investigators preliminary findings in HIV+ pregnant women suggest that PI-use is associated~     with declines in progesterone levels, which correlate with birth weight percentile. Since~     HIV-positive women have higher rates of pre-term delivery and low birth weight that may be~     magnified by the use of PIs, then progesterone supplementation could be of benefit to~     neonatal health in the context of HIV-positive pregnancy.~   "
89164|NCT02400008|"~     Selective laryngeal bilateral reinnervation as a secondary treatment in patients with~     bilateral vocal fold paralysis, previously treated by endoscopy, without residual arytenoids~     ankylosis.~      The surgical procedure is : functional reinnervation with the upper root of one phrenic~     nerve, is used for reinnervation of both cricoarytenoid muscles (laryngeal inspiratory~     muscles), and simultaneous reinnervation of adductor laryngeal muscles is performed by right~     and left thyro -hyoid nerves (coming from the hypoglossi) on both sides.~      Results are obtained after 6 to 9 months delay. In case of good inspiratory arytenoid~     abduction, and residual dysphonia, a secondary vocal fold medialization is done by an~     endoscopic approach 12 months after reinnervation (included in the protocol).~      Improvement is expected in voice and breathing, without aspiration.~   "
89165|NCT02399995|"~     This study is being done to learn more about health related quality of life factors in people~     having surgery for colorectal liver metastasis. The investigators will look at how these~     factors may change over time. The information gained from this study will help the~     investigators to understand the long-term effects that cancer treatments have on the health~     related quality of life of patients. This information is of high value and will help doctors~     talk to patients about the possible effects of their operations. While many patients live a~     long time after such operations, the studies that have been done do not tell the full story~     of what patients go through after surgery. This study will help us to understand cancer~     treatment from the patient's perspective. It will also help cancer patients make better~     decisions about their treatment options and will help them know what to expect after the~     operation.~   "
89166|NCT02399982|"~     This study aims to utilize emerging mobile application technology, as a tool for increasing~     the potency, accessibility, and efficacy of a guided self-help version of~     cognitive-behavioral therapy (CBT-GSH) for binge eating. The feasibility and efficacy of the~     adapted smartphone application created by Noom Inc., Noom Monitor, will be examined through a~     randomized control trial comparing CBT-GSH + APP with CBT-GSH conducted at the Mount Sinai~     School of Medicine's Eating and Weight Disorders Program. The investigators hypothesize that~     CBT-GSH with the addition of the Noom Monitor, will be significantly more acceptable, have~     greater uptake of self-monitoring, greater adherence to treatment, and greater reduction in~     objective binge episodes (OBEs) than standard CBT-GSH.~   "
89194|NCT02399618|"~     Recurrent or refractory Clostridium difficile Infection (RCDI), with a recent increased~     incidence, is one of the most difficult and increasingly challenges for CDI. Since Fecal~     Microbiota Transplantation (FMT) has been accepted as the first-line therapy for RCDI, it is~     prudent to consider less invasive and more convenient means of administering FMT. The~     majority of reported FMT procedures have been performed with fresh or frozen stool~     suspensions via colonoscopy or nasojejunal tube. Nowadays, using acid-resistant hypromellose~     capsules, Youngster et al. significantly simplified the clinical practice of FMT and removed~     the need for invasive gastrointestinal procedures. However, to avoid undesirable~     disintegration, those capsules containing stool suspensions must be kept frozen all the time,~     which extremely limits their widespread application. The purpose of this study is to evaluate~     the efficacy and safety of freeze-dried, capsulized FMT for RCDI.~   "
89167|NCT02399969|"~     The purpose of this study is to study acupuncture for the treatment of low back pain in the~     emergency department. Current treatments for low back pain in the emergency department~     generally include pills or injections of medications to treat pain and relax muscles.~     However, it is known that many of these medications have risks and toxicities which may limit~     their safe use in some patients. Therefore, new types of treatments are needed.~      Acupuncture is an ancient form of healing that has been practiced in some form for centuries.~     In modern times, acupuncture has been studied for the long-term treatment of low back pain~     and some research suggests it may be effective. However, very little research has examined~     the use of acupuncture for immediate pain relief in the emergency department.~      This research will study a type of acupuncture called Battlefield Acupuncture (BFA).~     Battlefield acupuncture was designed by a physician in the US military with the purpose of~     providing immediate pain relief. It involves the placement of 5 small needles in each ear.~     The needles may be removed at any time. The hypothesis of this study is that battlefield~     acupuncture may improve mobility and pain of patients with low back pain in the emergency~     department.~   "
89168|NCT02399956|"~     While the majority of women in the general population can breastfeed successfully, the~     investigators have limited knowledge about the correlates and sequelae of lactation success~     among women treated for pediatric malignancies. Childhood cancer treatments are known to~     cause late effects that frequently involve the endocrine system. Because normal lactation is~     dependent upon interplay of multiple endocrine factors, the investigators anticipate more~     breastfeeding difficulties in survivors that have diabetes, growth hormone deficiencies,~     thyroid disorders and obesity. In order to more fully inform clinicians and female survivors,~     the study of the burden of lactation failure is needed to begin to address the impact of~     pediatric cancer therapy on lactation success/failure and to examine the association of~     specific endocrine disorders on lactation outcomes.~   "
89169|NCT02399943|"~     This is a phase 2 study (the second phase in testing a new drug or drug combination) to see~     how useful the combination of two drugs, panitumumab and trametinib, are in patients with~     advanced colorectal cancer with KRAS, NRAS, or BRAF wild type (genes that are not mutated).~      Panitumumab is a drug that is approved by Health Canada for the treatment of advanced~     colorectal cancer with KRAS wild type. Panitumumab works by binding to and blocking the~     protein, epidermal growth factor receptor (EGFR) from working.~      Trametinib is a drug that is approved by Health Canada for the treatment of melanoma with a~     mutation in the BRAF gene. Trametinib works by binding to and blocking mitogen-activated~     protein kinase kinase (MEK) 1 and MEK2 from working.~      Previous studies have shown that the combination of panitumumab and trametinib may be more~     useful in KRAS, NRAS, or BRAF wild type colorectal cancer.~   "
89170|NCT02399930|"~     Currently, breathing rate and heart rate are checked by nursing staff manually every few~     hours and entered into a patient's medical record. The investigators are doing this study to~     see if a device that will automatically record breathing rate and heart rate every 15 minutes~     is as accurate as the manual measurement. The investigators will also see if these~     measurements, taken every 15 minutes, will help us predict adverse events more quickly and~     accurately than the measurements taken every few hours.~   "
89171|NCT02399917|"~     The goal of this clinical research study is to find the highest tolerated dose of the~     combination of lirilumab and 5-azacytidine that can be given to patients with AML or~     high-risk MDS. Researchers also want to learn if the drug combination can help to control the~     disease. The safety of the drug combination will also be studied.~      This is an investigational study. Lirilumab is not FDA approved or commercially available.~     5-azacytidine is FDA-approved and commercially available for the treatment of MDS, which can~     lead to AML, but it has not been approved for the treatment of AML. The use of these drugs in~     combination is investigational. The study doctor can explain how the drugs are designed to~     work.~      Up to 64 participants will be enrolled in this study. All will take part at MD Anderson.~   "
89172|NCT02399904|"~     This study was conducted to check the effect of California tri-pull taping method on post~     stroke shoulder subluxation, prior to conduct a large randomized clinical trial this study~     was conducted, and the result of the study was promising for the treatment of shoulder~     subluxation.~   "
89173|NCT02399891|"~     Cohort study aimed at evaluating the incidence of left ventricular (LV) dysfunction after~     myocardial infraction (MI) and assessing the prognostic utility of change in ejection~     fraction (EF) over the initial 12 months after MI.~   "
89174|NCT02399878|"~     Respiratory complications represent the second most frequent type of postoperative~     complications with an incidence estimated to range from 2.0% to 7.9%~      It has been shown that intra-operative protective ventilation is associated with a reduced~     risk of respiratory complications. The effects of intra-operative inspiratory oxygen fraction~     (FiO2) remain to be investigated.~      In this study, the investigators aim to investigate the association between intra-operative~     FiO2 and respiratory complication as well as surgical site infection and ICU admission in~     patients undergoing non-cardiothoracic surgery. The investigators primary hypothesis is that~     high intra-operative FiO2 increases the risk of postoperative respiratory complications~     independent of predefined risk factors.~   "
89195|NCT02399605|"~     Assess whether the application of electrical stimulation in patients undergoing subcutaneous~     colon cancer in a Multimodal Rehabilitation Program (Fast track) decreases the incidence of~     postoperative ileus, improving the results of morbidity and mortality, hospitalization and~     health care costs.~   "
89196|NCT02399592|"~     The purpose of this study is to to investigate the effect of tocotrienol as a nutritional~     supplement in combination with bevacizumab in patients with advanced ovarian cancer.~   "
89197|NCT02399579|"~     The purpose of this study is to better standardize the symptom recording of cat allergic~     persons under real-life conditions. A new self-assessed, home-based symptom score will be~     tested.~   "
89198|NCT02399566|"~     The purpose of this study is to compare effects of erlotinib and pemetrexed as maintenance~     therapy for lung adenocarcinoma. Primary Outcome is the progression free survival (PFS).~     Based on prediction of different potential benefit groups, this study may help the oncologist~     to optimize and improve the maintenance therapy plan for lung adenocarcinoma.~   "
89274|NCT02398578|"~     Phase I/II study to assess the safety and performance of the Amphora OAB system for treatment~     of urgency and frequency with or without urge incontinence caused by an overactive bladder.~   "
89275|NCT02398565|"~     We will examine the outcome of ventral hernia repair with subsequent pregnancy~   "
89175|NCT02399865|"~     Research evidence shows that there is a high prevalence of substance use among young people~     in the UK. Early onset and high levels of use are associated with a range of negative~     outcomes, including increased risk of later problematic use and dependence. A growing body of~     research has identified family interventions to be effective in treating young people's~     substance use problems. However, despite this evidence, takeup of family based approaches, at~     least in the UK, has been low. A key factor appears to be the resource intensive nature of~     many family interventions, making them difficult to implement and deliver in many service~     settings, especially in the context of substantial cuts to drug and alcohol services for~     young people (1). Another potential barrier may be the cultural adaptation of approaches~     developed in the USA to a UK setting. There is growing awareness of the need to adapt~     evidence-based treatments to different cultural groups and settings in order to ensure~     successful implementation (2,3,4).~      Following on from developmental and adaptation work, this study aims to demonstrate the~     feasibility of recruiting young people to specifically developed family and network based~     intervention. In addition the feasibility of training staff from existing young people~     addiction services to deliver this intervention will be explored and treatment retention will~     be assessed. Qualitative interviews will elicit the participants' views on the acceptability~     of the intervention and their experiences of both it and the study process.~   "
89176|NCT02399852|"~     Study to assess changes in carotid and aortic atherosclerosis in patients being treated with~     lomitapide.~   "
89177|NCT02399839|"~     To evaluate the outcomes of pregnancy in women treated with lomitapide.~   "
89178|NCT02399826|"~     This is comparison trial comparing human amniotic membrane to standard wound care for non~     healing diabetic foot wounds over a 12 weeks period~   "
89179|NCT02399813|"~     This is a single arm Phase 2 study. Stage 1 and 2 of the study are monotherapy evaluations of~     ADXS11-001 in 31 and 24 subjects, respectively with persistent/recurrent, loco-regional or~     metastatic SCCA of the anorectal canal that have received at least 1 regimen for the~     treatment of advanced disease~   "
89180|NCT02399800|"~     Rationale: Chronic pancreatitis is a chronic inflammatory disease of the pancreas which~     results in debilitating abdominal pain, decreased productivity and increased health care~     costs. Endoscopic ultrasound (EUS) guided celiac plexus block (CPB) is routinely used to~     treat pain related to chronic pancreatitis. While EUS guided neurolysis for pancreatic cancer~     has significant efficacy, the benefit of CPB for chronic pancreatitis pain is controversial~     and has not been studied in a rigorous manner.~      Objective: To assess whether EUS guided celiac plexus block decreases suffering,~     hospitalization, and opiate requirements related to chronic pancreatitis pain.~      Population: Patients undergoing EUS at Los Angeles County Hospital for painful chronic~     pancreatitis.~      Methods: Patients undergoing EUS to evaluate chronic pancreatitis with a typical visual~     analogue pain score >3, regular opiate use, and M ANNHEIM chronic pancreatitis score >6 will~     be eligible.~      Study Arms: Patients will be randomized to 1) diagnostic endoscopic ultrasound 2) endoscopic~     ultrasound with celiac plexus block~      Study Outcomes: The primary outcome will be a decrease in chronic pancreatitis pain assessed~     by the visual analogue scale and M ANNHEIM system at 24 weeks compared to immediately prior~     to the block. The ability to work and conduct normal activities, opiate medication~     requirements, and a Careprep symptom assessment at 24 weeks will also be compared prior to~     the block.~      Analytic Plan: The projected response rate to EUS guided CPB is 52%. Given known 30% placebo~     response in patients with pain related to chronic pancreatitis we anticipate that 83 patients~     will need to participate to demonstrate a difference. We aim to enroll 90 patients in this~     study.~   "
89181|NCT02399787|"~     The aim of the post doc project is investigate which genes regulate implantation in order to~     analyze specific proteins and microRNA in the spent culture media with the long-term goal of~     developing a non-invasive method of embryo assessment and selection. This will be achieved by~     conducting a targeted NGS analysis, based on list obtained from a non-published pilot study.~     When further validated by q-PCR, the expression of specific microRNAs known to influence the~     final list of genes will be analyzed in the spent culture media and the protein products of~     the genes recovered from the media will be quantified. The level of specific microRNAs and~     proteins will be related to aneuploidy and implantation potential. If the level of specific~     microRNA and/or proteins correlates with pregnancy, the study will form the basis for~     developing a clinical applicable precise method of improved embryo selection and thus~     improved IVF treatment.~   "
89182|NCT02399774|"~     Leboride is a dental support device that was developed for reducing pain during active labor.~     It is made of an inert material, placed in the woman's mouth and does not disturb breathing,~     talking, or any other activity expected during labor. It is a single-use device, each user~     receives a new one.~      This study hypothesis is that the Leboride use can reduce pain during breastfeeding, by that~     improve women's breastfeeding experience, and increase breastfeeding rates.~   "
89183|NCT02399761|"~     Parents of newborns will be invited to test if their newborns are affected with Aromatic~     L-amino Acid Decarboxylase (AADC) deficiency.~   "
89184|NCT02399748|"~     Prospectively follow patients with Pompe disease underwent enzyme replacement therapy.~   "
89185|NCT02399735|"~     The purpose of this study is to explore the safety of NK cells from Sibship in patients with~     recurrent hepatocellular carcinoma after liver transplantation.~   "
89186|NCT02399722|"~     In surgical units negative pressure wound therapy (NPWT) is often used to facilitate wound~     healing. The recommended frequency of change every third to fourth day causes an immense~     workload.~      The purpose of this study is to evaluate the effect of an additional polymeric membrane~     interface dressing (PolyMem® WIC) as primary wound contact layer in NPWT in comparison to~     NPWT alone on the number of required dressing changes until wound closure as the primary~     endpoint. Secondary endpoints are: time to heal and wound associated pain.~   "
89233|NCT02399111|"~     The purpose of this research study is to investigate if a new negative pressure incision~     (surgical cut) management system, could reduce the occurrence of groin wound infections after~     vascular surgery. This is a single use, sterile dressing that is applied to the patient's~     skin. It has an attached battery-powered unit that provides negative pressure (a vacuum~     environment) to the dressing and a disposable canister for the collection of wound fluids.~     The patient is being asked to participate in this study because the patient is planning to~     have a vascular surgery procedure that involves groin incision.~   "
89187|NCT02399709|"~     Tobacco smoking is the number one preventable cause of disease worldwide. Unfortunately,~     there are few smoking cessation agents and their effectiveness has been shown to be~     relatively limited and is associated with potential unwanted effects. Therefore, the~     discovery of new medications that can facilitate abstinence and reduce relapse to cigarette~     use represents a pressing necessity. In the attempt to find molecules that could reduce~     drug-seeking behavior, we discovered that simvastatin reduces cocaine and nicotine, but not~     food, seeking behavior in rats. This discovery of a new therapeutic application for an~     already marketed class of compounds may greatly facilitate the translation from preclinical~     to clinical setting. In this project, we aim at investigating whether simvastatin is an~     effective smoking cessation agent in humans.~      The study design is a multicenter, randomized, double blind 2 parallel groups, clinical trial~     with an intention-to-treat analysis. Smokers will randomly be assigned to receive simvastatin~     or placebo for 3 months. 200 smokers (100 receiving simvastatin and 100 receiving placebo)~     will be recruited through already established networks of general practitioners. The primary~     outcome of the efficacy of simvastatin will be the rate of smoking abstinence during the last~     month of the 3-month treatment period, defined as reported continuous abstinence from smoking~     and confirmed by expired air carbon monoxide and urinary cotinine concentration. The last~     assessment will be done 6 months after the predefined quit date.~      The results of this proof-of-concept study may open new perspectives in the treatment of~     tobacco use and dependance.~   "
89188|NCT02399696|"~     Primary care patients typically do not receive adequate PTSD treatment because of their~     reluctance to engage in empirically-supported treatments offered in specialty care settings.~     Effective treatments for PTSD are also typically not provided in primary care. Brief~     skill-based treatments offered in primary care may alleviate symptoms and prepare patients to~     engage in additional treatment. VA primary care patients with PTSD (N=62) were recruited for~     a randomized clinical trial comparing a Primary Care-Brief Mindfulness Program (PC-bMP) to~     primary care-treatment as usual (PC-TAU). PC-bMP is a 4-week group program adapted from the~     8-week Mindfulness Based Stress Reduction (MBSR) curriculum. Veterans in the PC-bMP condition~     demonstrated significantly greater decreases in PTSD and depressive symptoms from~     pre-treatment to post-treatment compared to PC-TAU. These gains were maintained at 8 and 12~     week follow-up. PC-bMP participants experienced clinically significant decreases in PTSD,~     averaging a 15-point drop on the Clinician-Administered PTSD Scale. Exploratory analyses~     revealed that the describing, non-judging, and acting with awareness facets of mindfulness~     may account for decreases in PTSD. Our data support preliminary efficacy of a brief~     mindfulness-based intervention for Veterans with PTSD in primary care. Further research is~     needed to investigate how PC-bMP may facilitate engagement into full length~     empirically-supported treatment for PTSD.~   "
89189|NCT02399683|"~     Mucosal immunology during helminth infection~   "
89190|NCT02399670|"~     The femoral-offset (FO) is one of the important perioperative parameters in THA. A~     prospective cohort study was conducted between September 2010 and December 2013. All patients~     with unilateral primary osteoarthritis (OA) treated with THA were considered for inclusion.~     Patients with secondary OA, previous spinal, pelvic, or lower limb injuries or fractures were~     excluded. Global FO was measured in each patient within 3 months before the THA and at the~     second postoperative day using a standardized protocol. According to the postoperative~     measurement, patients were divided into three groups: 1) the decreased FO group, where the FO~     of operated side was reduced more than 5mm compared with the contralateral side, 2) the~     restored FO group, where the FO of operated side was within 5mm restored compared with the~     contralateral side, and 3) the increased FO group, where the FO of operated side was~     increased more than 5mm compared with the contralateral side.~      Patients were followed-up at 12 - 15 months postoperatively with self-administered WOMAC and~     EQ-5D questionnaires in addition to a clinical assessment with palpation of the operated hip~     and measurement of the abductor muscle strength.~   "
89191|NCT02399657|"~     A Single Arm, Single Dose Study to Evaluate the Effect of intravitreal dexamethasone implant~     (Ozurdex®) on hard exudates of diabetic macular edema.~   "
89192|NCT02399644|"~     Only to a limited extent has been compared the effectiveness of physical exercise and~     psychological interventions in subjects with chronic pain. Knowledge about this is necessary~     in order to compose optimal multimodal rehabilitation programs at different health care~     levels. Moreover, assuming that both types of interventions have effects, these effects may~     necessarily not concern the same outcome variables. Therefore it may be important to~     understand to what extent the effects overlap and the extent to which the effects are~     isolated to an intervention.~      The overall strategic purpose of the present study is to develop effective multimodal~     rehabilitation programs. In this study the effectiveness of following three interventions are~     compared.~        -  Group-based rehabilitation according to a concept based on an Acceptance and Commitment~          Training -Stress Management Intervention (ACT-SMI)~        -  Group-based rehabilitation compromised of physical exercise (Exercise).~        -  Group-based discussion concerning pain and its consequences (i.e., the control group,~          CON) The effectiveness is investigated with respect to long-term effects on pain and its~          consequences, including perceived health and return to work / sick leave.~      The overall hypothesis is that the former intervention means better long-term results because~     it clearly helps the individual to process the psychological aspects of itself likely to have~     long lasting effects.~   "
89193|NCT02399631|"~     An enhanced recovery program has been developed to provide for colon cancer patients faster~     and more personalized postoperative treatment. Most of the previous studies have showed that~     the efficacy of the enhanced recovery program on both subjective and objective physical~     recovery of patients. However, such studies are rarely conducted in South Korea. The purpose~     of this study is to evaluate the feasibility and efficacy of a postoperative enhanced~     recovery program in patients who underwent laparoscopic colon cancer surgery at a tertiary~     hospital in Korea.~   "
89234|NCT02399098|"~     Focusing attention is pertinent to the performance of closed self-paced motor tasks. The~     following study will examine the effectiveness of internal and external focus of attention~     instructions on the performance of a dart throwing task under rested and fatigue (after~     performing intense exercise) conditions. As well as the relationship between attentional~     focus instructions and gaze behavior under these two conditions.~   "
89199|NCT02399553|"~     The number of turf fields has experienced an important increase in public and private~     facilities during the last years. This artificial surface will be predominant in any soccer~     field in the next years. Among turf fields there are many different types depending on their~     construction characteristics (with and without asphalted base, elastic base, rubber filling,~     etc.). Officially all types of artificial turfs should have similar stability and impact~     absorption characteristics. On the other hand there is a great variety of soccer-boots,~     especially for youth soccer players, similar to the football stars.~      Many evidences support the fact that when a person exercises many different type of~     impacts-stimulus are necessary in order to stimulate bone and skeletal muscle systems.~     However, it is not known yet whether this effect can be extended or shortened depending on~     the type of artificial surface and soccer-boots used, or even more whether it could be more~     or less dangerous and/or provoke injuries/disagreement among the users. Little information is~     available in youth soccer player pointing in the same direction but still controversial.~     Furthermore, bone strength do not only depends on bone mass but on bone structure and~     microarchitecture. The cross sectional area, cortex thickness or trabecular density are~     important aspects of bone health. There are few studies on the effect of interaction between~     turf field and soccer boots on bone architecture of youth soccer players. This information is~     relevant for present and future health of adolescents practicing football and for all the~     organizations promoting this sport.~      Due to the fact that turf fields are preferentially used by youth populations, it is~     important to know the real effects of the interaction between of different type of artificial~     surfaces and soccer boots on children bone mass development. Nowadays, there are no data~     and/or defined guidelines that can answer those unresolved questions, thus the main aim of~     the present project is to identify which turf field and soccer boots are the most adequate to~     optimize the acquisitions of bone mass in children soccer players.~   "
89200|NCT02399540|"~     Rationale: About 80% of stroke patients suffer motor impairments, but current therapies have~     limited effects on motor recovery. Therefore, investigating new potential therapeutic~     approaches is crucial. Transcranial Direct Current Stimulation (tDCS) is a form of~     non-invasive electrical stimulation where a weak current is applied through electrodes over~     the scalp. This stimulation is known to (1) induce changes in neuronal excitability -which~     can last up to one day with late LTP-like plasticity protocols- in a polarity and~     site-specific manner, and (2) facilitate motor learning and stroke recovery. However, it is~     unknown how the motor cortex excitability changes that follow tDCS relate to the increase in~     motor learning and recovery potential. The currently upheld hypothesis is that motor learning~     needs to be synchronized in time with electrical stimulation (paired stimulation), but recent~     results from our lab suggest that tDCS also increases skill learning after stimulation has~     ended (unpaired stimulation). If this is true, tDCS has a much larger therapeutic window and~     is a more valuable clinical tool than currently believed. Therefore, the investigators want~     to investigate how late LTP-like plasticity tDCS affects the increase in skill learning~     normally seen with tDCS when applied 24 hours before training. The outcome of this study can~     provide important guidelines on effective motor therapy during stroke rehabilitation.~      Objective: Identify the effect of late LTP-like plasticity tDCS in chronic stroke patients on~     skill learning 24 hours later.~      Study design: Double-blinded, randomized between-subjects trials. Study population: Chronic~     stroke patients. Main study parameters/endpoints: The main objective of the study is to~     determine the effect of late LTP-like plasticity tDCS on skill learning 24 hours later. As a~     motor learning paradigm, the investigators will use a circuit tracking task which chronic~     stroke patients perform better if tDCS is applied concurrently. During this task, patients~     have to trace a cursor over a circuit as fast and accurately as possible by moving a computer~     mouse. Skill will be quantified by calculating a combined speed/ accuracy score and skill~     improvement compared to baseline (LI; the learning index) will be compared between the sham,~     conventional unpaired tDCS, conventional paired tDCS groups and the late LTP-like plasticity~     tDCS groups.~   "
89201|NCT02399527|"~     Lymphatic anomalies are a rare subset of vascular anomalies that are poorly understood. the~     understanding of the natural history, long-term outcomes, risk factors for morbidity and~     mortality, and the relative benefit of medical therapies and procedures is limited.The goal~     of this project is to better understand these diseases and improve the care of theses rare~     patients. To do this, the investigators are conducting an observational study of patients~     with lymphatic anomalies, including an annual follow-up questionnaire to gather prospective~     data on mortality, morbidity, treatments, and functionality as well as quality of life.~   "
89202|NCT02399514|"~     Improvement of sleep quality in emphysema patients is desirable. Yet, there are no data of~     patients treated with RePneu coils. This monocenter prospective study investigates the effect~     on sleep quality of RePneu coils for reduction of dynamic hyperinflation in advanced disease~     stages of pulmonary emphysema.~      Patient's sleep will be studied in three Polysomnography measurement nights, one prior to~     Coil Treatment, one six months after, and one twelve month after.~      Primary objective is to investigate differences in sleep quality 6 and 12 months after Coil~     Treatment.~      Further endpoints are changes in daily activity and sleep (actigraphy), 6MWT, lung function~     parameters, and questionnaires (SGRQ, mMRC dyspnoe scale).~   "
89203|NCT02399501|"~     Prospective comparative study including 100 infertile patients with suspected uterine lesion.~     2D ultrasound, sonohysterography , 3D ultrasound and hysteroscopy will be done to evaluate~     uterine cavity.~   "
89204|NCT02399488|"~     Continuous haemoglobin determination could improve the outcomes of several patients in risk~     of bleeding during surgery. An in vivo calibration has been introduced to the device after~     our team found its need. The uncalilbrated validation of the Masimo Radical 7 continuous~     haemoglobin monitor has been made in various papers, although it has been compared to point~     of care devices, thus introducing an error as such point of care devices although validated~     for haemoglobin determination, are not as accurate as the gold standard. The validation of~     the gold standard calibrated device has not been described yet.~      When compared to the accepted gold standard (cyanmethemoglobin method, Coulter), accuracy and~     precision of the continuous haemoglobin monitor could be good enough to be used~     interchangeably with the gold standard.~   "
89205|NCT02399475|"~     Subclinical hypothyroidism, defined as an elevated TSH in the setting of normal thyroid~     hormone levels, is a common diagnosis in the elderly. The purpose of this study is to examine~     the hypothalamic-pituitary-thyroid axis in men and women aged 70 years and older with~     persistent subclinical hypothyroidism. To evaluate the mechanism behind this condition,~     participants will undergo thyrotropin releasing hormone stimulation testing at 3 visits:~     baseline and while taking two different thyroid hormone preparations, levothyroxine and~     liothyronine. The investigators will also assess physiologic responses to these two different~     thyroid hormone medications to help us understand how the thyroid works in advanced age.~   "
89206|NCT02399462|"~     This is an open label safety and feasibility trial using Acthar® in addition to~     center-specific standard therapy including plasma exchange, for treatment of post transplant~     recurrent FSGS and post transplant recurrent idiopathic membranous nephropathy. Subjects will~     receive Acthar® 40 units subcutaneously (SC) twice weekly for two weeks then 80 units SC~     twice weekly for 24 weeks.~   "
89207|NCT02399449|"~     An approved treatment for anemia or low blood count due to chronic kidney disease is IV~     (intravenous, given into the vein) injection of an iron treatment. IV iron increases iron in~     the blood. Many IV iron therapies are now available in both brand name and generic forms. One~     common IV iron product is sodium ferric gluconate (SFG) sold as brand name Ferrlecit.~     Recently, a generic version of Ferrlecit was approved but was felt to be possibly more toxic~     than the brand product. The purpose of this research project is to see if the brand and~     generic IV iron products produce the same amount of iron in the blood in healthy volunteers,~     including an iron form that more toxic than other iron forms.~   "
89208|NCT02399436|"~     Most of the nation's serious chronic health challenges and causes of death, including~     diabetes, heart disease, cancer, and obesity, are directly linked to sub-optimal diet. Both~     poor diets and associated disease are disproportionately common in the Appalachian counties~     of eastern Kentucky, a region with stark health inequities, including elevated rates of~     obesity, overweight, and premature mortality. The purpose of this pilot study is to evaluate~     a multi-component intervention developed through community-based participatory research~     methods for improving access to healthy foods and enhancing dietary intake in eastern~     Kentucky. The intervention components evaluated in this study consist of a social marketing~     campaign delivered to middle and high schools to promote healthy snacking and water~     consumption, and a series of group cooking classes for adults.~   "
89209|NCT02399423|"~     South Asians have a much higher risk of diabetes compared to Europeans and investigators~     don't know why this is. Investigators think that South Asians' capacity to store fat safely~     under the skin is lower than Europeans, so they start to store fat around internal organs and~     in liver and muscle, and at lower body weights than Europeans. These increased levels of~     internal fat storage are thought to increase risk of diabetes.~      The purpose of the study therefore is to investigate whether there are differences with~     weight gain and weight loss in fat storage, fat cell function and metabolic risk factors, in~     South Asians compared with Europeans. Investigators will compare South Asian and European men~     at the start of the study, after they have gained about 7% body weight, and again after they~     have lost 7-15% body weight (from peak weight) to see how gaining and losing weight affects~     fat storage within the body and the function of fat cells. Investigators will also assess the~     effect of weight gain and weight loss on metabolism, fitness and risk factors for diabetes~     and heart disease.~   "
89210|NCT02399410|"~     The Bev-IP trial is designed to assess the feasibility and efficacy of a combined treatment~     consisting of perioperative combination chemotherapy with the vascular endothelial growth~     factor A inhibitor bevacizumab and cytoreductive surgery with intraperitoneal oxaliplatin.~   "
89211|NCT02399397|"~     This study aims to evaluate the influence of age and sepsis on in vivo activity of OATP1A2~     using rocuronium (ROC) as a probe and evaluating the pharmacokinetics and pharmacodynamics in~     ASA I-III surgical patients. Thus, adult patients without sepsis (control group, n= 12),~     adult patients with sepsis (sepsis group, n= 12) and elderly patients without sepsis (elderly~     group, n= 12), all submitted to small to medium-sized surgeries who were induced with~     individual doses of rocuronium, fentanyl and propofol are being investigated.~   "
89212|NCT02399384|"~     The investigators propose to correlate 1) cardiac MRI pericardial adipose volume, 2) the~     presence of pericardial monocytes and 3) circulating immune biomarkers in persons with and~     without CHD and HIV infection compared to seronegative controls with known CHD. The~     investigators aim to test the hypothesis that higher amounts of pericardial fat deposition~     and increased presence of monocytes within this adipose tissue are associated with underlying~     coronary artery disease in persons with HIV infection as measured by cardiac MRI.~   "
89213|NCT02399371|"~     This phase II trial studies how well pembrolizumab works in treating patients with malignant~     mesothelioma, a cancer of the linings around the lungs (pleura) or abdomen (peritoneum).~     Monoclonal antibodies, such as pembrolizumab, work by blocking a protein called programmed~     cell death 1 (PD-1) which may stimulate an immune response and kill tumor cells.~   "
89214|NCT02399358|"~     Prospoctive cohort of high-dose cyclophosphamide exposed patients. With active estandardize~     screening of hyponatremia development in the follow up period.~   "
89215|NCT02399345|"~     This open-label study will evaluate the safety and efficacy of co-formulated~     ombitasvir/paritaprevir/ritonavir and dasabuvir co-administered with sofosbuvir with or~     without ribavirin administered for either 4 or 6 weeks in treatment naive adults with chronic~     HCV-genotype 1 infection without cirrhosis~   "
89216|NCT02399332|"~     This project is an initiative to bring physicians, nurses, community pharmacists and patients~     together in collaborative planning in the management of diabetes, which aligns with the~     collaborative, team based aspects of family medicine as a community based discipline. Alberta~     funds both physicians and community pharmacists to complete a comprehensive assessment and~     plan for patients with qualifying medical conditions. Our research hypothesis is that a~     collaborative approach between healthcare providers involved in delivering care will improve~     individual patient outcomes with the primary outcome being improved glycemic control. Health~     care utilization and medication adherence will also be assessed. This project will compare~     the results of comprehensive annual health care plans implemented over a period of twelve~     months with or without involvement from community pharmacists. It is hypothesized that~     involvement of community pharmacists and their collaboration with physicians will lead to~     improved outcomes.~   "
89217|NCT02399319|"~     The purpose of this study is to compare subcutaneous internal fixation and open plating of~     the symphysis in patients with a disruption of the symphysis requiring stabilization.~   "
89218|NCT02399306|"~     This is a randomized, prospective, multicenter study. The aim of this study was to compare~     the changes of body weight,survival,toxicity,quality of life and opportunistic infection~     frequency in Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma between and after~     chemoradiotherapy with or without enteral nutrition therapy.~   "
89219|NCT02399293|"~     Investigates computer based cognitive rehabilitation and training using the N-back task with~     a Visual Search task as an active control. The overall purpose is to provide (further)~     evidence about the efficacy (or lack of efficacy) of the N-back task and to find points of~     convergence and divergence between patients with acquired brain injury and non-impaired~     subjects.~   "
89220|NCT02399280|"~     The purpose of the present study is to evaluate the effect of consuming higher caloric intake~     at lunch in contrast to dinner on weight loss of obese and overweight female adults when they~     are in a multidisciplinary weight loss plan .~   "
89235|NCT02399085|"~     This is an open-label, multicentre study to characterize the safety and efficacy of the human~     anti CD19 antibody MOR00208 in combination with Lenalidomide in adult subjects with~     relapsed/refractory Diffuse Large B-cell Lymphoma (DLBCL) who have had at least one, but no~     more than three prior systemic regimens and who are not eligible for high dose chemotherapy~     (HDC) with autologous stem-cell transplantation (ASCT) at the time of study entry.~   "
89301|NCT02398227|"~     This is a study comparing a new treatment (HOPE) to supportive therapy in the treatment of~     PTSD in residents of battered women's shelters.~   "
89221|NCT02399267|"~     The requirement for invasive mechanical ventilation is a defining feature of critical~     illness. Liberation or weaning is the process during which the work of breathing is~     transferred from the ventilator back to the patient. Approximately 40% of the time spent on~     mechanical ventilation is dedicated to weaning. Limiting the duration of invasive ventilation~     has been identified as a key research priority in critical care. Studies support the use of~     screening protocols (once daily vs. usual care) to identify weaning candidates and the~     conduct of tests of patient's ability to breathe spontaneously (SBTs). While once daily~     screening is the current standard of care in national intensive care units (ICUs), it is~     poorly aligned with the 24/7 ICU care environment wherein a critically ill patients' status~     can change from hour to hour. Only one large trial has compared alternative SBT techniques~     [T-piece vs PS (Pressure Support)]. No trial has compared a strategy of more frequent~     screening to once daily screening or alternative SBT techniques. The presence of respiratory~     therapists (RTs) 24/7 in North American ICUs presents a unique opportunity to screen more~     frequently, conduct more frequent SBTs, and determine the optimal strategy to liberate~     critically ill adults from invasive ventilation.~      The investigators propose to conduct a pilot randomized trial in 100 critically ill adults~     comparing 'once daily' screening to 'at least twice daily' screening and PS vs. T-piece SBTs~     in 12 Canadian ICUs. In the proposed trial, the investigators will (i) assess their ability~     to recruit critically ill adults who can breathe spontaneously or initiate breaths on one of~     several commonly used modes of ventilation into the trial, (ii) evaluate clinician's ability~     to implement the trial as designed, (iii) assess current practices in sedation, analgesia and~     delirium management and timing of patient mobilization prior to conducting screening~     assessments, (iv) identify barriers (clinician, institutional) to enrolling patients, (v)~     characterize trial participants based on weaning difficulty, and (vi) obtain preliminary~     estimates of the impact of the alternative screening and SBT strategies on clinically~     important outcomes.~   "
89222|NCT02399254|"~     Pulmonary rehabilitation clearly increases exercise capacity, but its effect on physical~     activity in the home and community settings is less clear. It may take a longer time for this~     increase in physical activity to occur. It has been stated in an editorial that it takes 3~     months to train the muscles but 6 months to train the brain. The Investigators will first~     evaluate the change in physical activity following pulmonary rehabilitation using~     state-of-the-science motion detectors, then Investigators will follow the trajectory of~     physical activity over the next several months.~   "
89223|NCT02399241|"~     Lung Health research study (Development of a predictive model) - To determine whether the~     I-neb breathing parameters (flow data) can act as a surrogate marker for lung function~     (Forced Expiratory Volume in 1 second FEV1) hence allow early detection of decline in lung~     function in cystic fibrosis patients.~   "
89224|NCT02399228|"~     The initial proposed clinical study will be conducted in adult head and neck cancer subjects.~     This will be an open-labeled, proof of concept trial to evaluate the efficacy, safety and~     tolerability of EISO in a form of oral rinse as adjunctive therapy to standard of care.~     Santalis believes that the proposed study is a prudent and appropriate approach to~     investigate the potential of their product to prevent or improve oral mucositis symptoms~     commonly seen in subjects undergoing radiotherapy with or without chemotherapy.~   "
89225|NCT02399215|"~     This phase II trial studies how well nintedanib works in treating patients with~     neuroendocrine tumors that have spread from where they started to nearby tissue or lymph~     nodes (locally advanced) or have spread from the primary site (place where they started) to~     other places in the body (metastatic). Nintedanib may stop the growth of tumor cells by~     slowing or stopping a certain type of receptor called vascular endothelial growth factor~     receptor (VEGFR) from attaching to its target. This may stop the growth of neuroendocrine~     tumors by blocking the growth of new blood vessels necessary for tumor growth.~   "
89226|NCT02399202|"~     To characterize the pharmacokinetics of LCI699 following a single oral dose in adult subjects~     with various degrees of impaired renal function.~   "
89227|NCT02399189|"~     The purpose of this study is to evaluate the efficacy and safety of chemotherapy with MT-R~     followed by autologous stem cells transplantation in newly-diagnosed primary central nervous~     system lymphoma.~   "
89228|NCT02399176|"~     The study measures change in bone mineral density by the DEXA scan before and two or more~     years after beginning ten minutes of daily yoga designed to put pressure on the spine, hips~     and femur.~   "
89229|NCT02399163|"~     The study will evaluate and compare the potential anti-caries efficacy of a test regimen:~     placebo (fluoride free) toothpaste (twice daily use) plus fluoride mouthwash (once daily~     use), in comparison with brushing with a placebo toothpaste alone (twice daily use), to~     remineralize previously demineralized enamel specimens, as measured by Surface MicroHardness~     Recovery (%SMHR).~      This will be a single center, randomized, laboratory analyst blinded, placebo, four~     treatment, cross-over study in healthy participants. Participants will be assessed at~     baseline and at the beginning and end of each treatment visit to monitor clinical efficacy~     and safety.~   "
89230|NCT02399150|"~     Background: In the emergency setting, acute abdominal pain is a diagnostic challenge, as pain~     is a subjective measure, and serious causes needing surgical intervention do not always meet~     the clinical picture. Biomarkers measuring the individual stress or pain level may aid in~     identifying surgical emergencies, but there are many influencing factors that have to be~     taken into account.~      Objective: To evaluate defined stress biomarkers for their diagnostic and prognostic utility~     in measuring pain, and to evaluate potential influencing or confounding factors.~      Design: Prospective observational study in 200 patients presenting to the emergency~     department with acute abdominal pain.~      Estimated duration: May 2015 - May 2016 Location Setting: Emergency Department (ED) of the~     Hôpital Universitaire Pitié-Salpétrière, Paris, France.~      Study population: 200 patients presenting to the ED with acute abdomen~      Eligibility criteria:~        -  Inclusion criteria: Presentation at ED with acute abdominal pain, aged at least 18 years~        -  Exclusion criteria: no informed consent, pregnancy, homeless, no social assurance~      Procedure:~      Patients presenting to the ED with acute abdominal pain will be included after informed~     consent is given. Blood and saliva samples will be drawn initially and after 4 hours, and~     baseline data assessed. All diagnostic procedures results and diagnosis made by the treating~     physicians as well as initiated treatment will be recorded Final diagnosis and outcome will~     be assessed by 2-week-telephone interview.~      Measurement of candidate biomarkers will be performed in collected material. Copeptin and SAA~     will be measured as potential biomarkers, as a control value, cortisol will be obtained.~     Other biomarkers will be in consideration, depending upon availability and financial aspects.~      Safety evaluations: All recommendations outlined in the ICH Guidelines for Good Clinical~     Practice will be adhered to throughout this trial.~      Sample size considerations: The number of patients of this pilote study is based on the~     estimate of 25 % or 50 of acute abdomen patients to have a surgical emergency.~      Significance of the study: If a biomarker is found that safely discriminates between surgical~     urgency and harmless abdominal pain, this will spare radiologic exposure in often young~     patients and will aid in optimized allocation of health care resources.~   "
89231|NCT02399137|"~     The purpose of this study is to determine whether the combination of MM-141 plus~     nab-paclitaxel and gemcitabine is more effective than nab-paclitaxel and gemcitabine alone~     based on Progression Free Survival (PFS) in front-line metastatic pancreatic cancer patients~     with high serum levels of free IGF-1.~   "
89232|NCT02399124|"~     This experiment is designed for post marketing data collection of a cryosurgical system~     [PROSENSE™ of IceCure Medical], for the treatment of renal cell carcinoma (RCC).~   "
89323|NCT02397941|"~     Purpose of the study is the assessment of interrectal distance and dimensions of the muscles~     of the lateral abdominal wall in pregnant and non-pregnant women~   "
89239|NCT02399033|"~     Study Objective: To evaluate the efficacy and safety of Xihuang Capsules prevention of~     recurrence in patients with hepatocellular carcinoma after hepatectomy.~      Study Design: The study was A Multicenter, Randomized, Controlled, Open-Label, Parallel-Group~     Clinical Trial. Patients will be randomly assigned to Xihuang Capsules group or the control~     group by the proportion of 2: 1.~      The total sample size: 1000 cases. Study Process: The study is divided into three phases: the~     screening phase, treatment phase, follow-up phase.To complete screening in two weeks,~     patients who fit the criteria were randomly assigned to Xihuang Capsules group or the control~     group.In two weeks after hepatectomy, Xihuang Capsules group received Xihuang Capsules~     (2g,bid), Continuously taking to cancer recurrence or death.Control group was not received~     Xihuang Capsules. In the first month to three years after treatment, Conducting visits for~     once every three months,to evaluate the efficacy and safety with hepatocellular carcinoma~     recurrence rate in the three years after hepatectomy as the primary outcome. When entering~     the follow-up phase, Keeping in touch with patients withdrew from the study for a clinic or~     telephone follow-up every three months.~      From signing informed consent till the end of the study, inspecting the adverse events and~     concomitant medications for all subjects in each visit.~   "
89240|NCT02399020|"~     33 individuals with a psychotic disorder were given 22-24 sessions weekly or twice weekly of~     Social Cognition and Interaction Training (SCIT) and evaluated at the baseline and after the~     intervention. Main outcome was improvement in social cognition according to specific measures~     of facial emotion identification, Theory of Mind, attributional bias, social cognitive~     accuracy and metacognitive overconfidence.~   "
89241|NCT02399007|"~     A clinical trial of total Hip system used in Primary Total Hip Arthroplasty in China.~   "
89242|NCT02398994|"~     This multi-center randomized controlled trial evaluates if the addition of intravenous~     immunoglobulin to standard treatment of corticosteroids improves outcome in children and~     adults with first episode of Transverse Myelitis of Neuro-myelitis optica. Half of~     participants will receive corticosteroids alone, whilst the other half will receive~     corticosteroids plus intravenous immunoglobulin.~   "
89243|NCT02398981|"~     In the developed world critical illness is routinely treated in an intensive care unit (ICU)~     by highly specialized physicians, nurses and support staff. This model of intensive care is~     spreading rapidly to low and middle income countries and as it spreads, challenges and~     limitations to this model arise. In resource-poor settings, inadequate human resources,~     training, and equipment all present barriers to safe and effective use of life-saving~     procedures. The advances in medical informatics and human factors engineering have provided~     tremendous opportunity for novel and user-friendly clinical decision support (CDS) tools that~     can be applied in a complex and busy hospital setting. Real-time data feeds and standardized~     patient care tasks in a simulated acute care environment have been proven to have a~     significant advantage of a novel interface (compared to a conventional) in reducing provider~     cognitive load and errors. Currently researchers within the investigator's research group~     have developed and are pilot testing a simple electronic decision support tool: CERTAIN~     (Checklist for Early Recognition and Treatment of Acute Illness). This tool has been~     successfully tested and validated in simulated settings and is being implemented as pilot~     study in 18 countries. Worldwide infant and early childhood mortality continues to be very~     high partly due to the inability to recognize and respond aggressively to critical illnesses.~     Investigators expect that adaptation of the algorithms from CERTAIN has potential to be a~     powerful tool to improve on the medical care of children in developing countries.~     Investigators aim in this project is 1) to develop a pediatric adaptation of CERTAIN~     (CERTAINp) and 2) to implement it into clinical practice in resource-poor settings and~     evaluate the impact of the tool on the processes and patient outcomes.~   "
89244|NCT02398968|"~     Recurrent upper respiratory infections ( RURTIs) are common in school aged children. An~     adequate iron status might reduce their prevalence. The aim of the study is to assess the~     percentage and type of RURTIs in Egyptian school children, assessing the percentage of iron~     deficiency anemia (IDA) and the effect of iron supplementation on the recurrence and severity~     of upper respiratory tract infections .~   "
89245|NCT02398955|"~     Biomime stent is a novel sirolimus-eluting stent (SES) (Meril Life Sciences Pvt. Ltd.,~     Gujarat, India) with an ultra-thin stent platform (65 μm) and a biodegradable polymer~     licensed for the treatment of de novo coronary lesions. However no data regarding the~     efficacy and safety of this stent in an all-comers patient population treated with~     percutaneus coronary interventions (PCI) have been published so far. In this registry the~     investigators aimed to collect clinical and angiographic information about an extensive~     all-comers employ of this novel stent.~   "
89246|NCT02398942|"~     Aim:~      The aim of this study is to analyze the clinical and radiological outcomes of patients with a~     proximal pole fracture of the scaphoid~      Primary null hypothesis:~      There are no factors associated with nonunion of a proximal pole fracture of the scaphoid.~      Secondary null hypothesis:~      Patients with an acute proximal pole fracture of the scaphoid have QuickDASH (Disabilities of~     the Arm, Shoulder, and Hand) scores at or above the population norm (a score of 13 in the~     Norway and 10.9 in the United States), 2 to 6 months after injury.~   "
89247|NCT02398929|"~     This is an open-label, placebo run-in study to investigate the genetic and biomedical~     predictors of blood pressure response to bisoprolol. After informed consent is obtained,~     subjects will be withdrawn from previous antihypertensive therapy and given placebo for at~     least 2 weeks. Compliance will be assessed using pill counting, and any subject will a~     compliance less than 80% during the placebo run-in period will be excluded from the study.~     Bisoprolol 2.5 mg will be given once daily for 6 weeks. At baseline and after 6 weeks on~     bisoprolol 2.5 mg the clinic sitting blood pressure, 24-hour ambulatory blood pressure (if~     the patient is willing to do this), clinical characteristics and biochemical profile will be~     measured. Central aortic blood pressure will be measured with the A-PULSE device at baseline~     and after 6 weeks treatment.~      After completing 6 weeks treatment with bisoprolol 2.5 mg daily, the patient will continue~     treatment with bisoprolol for a total of 24 weeks unless there is any adverse event that~     requires discontinuation of bisoprolol.~   "
89249|NCT02398903|"~     The aim of our study is to assess the concentrations of different oral contraceptive agents~     in morbid obese women before and after two types of bariatric surgeries (RYGB and sleeve~     gastrectomy) in order to study the role of the surgery and the role of body weight on drug~     concentrations, and to compare these concentrations with those of normal-weight women.~   "
89250|NCT02398890|"~     Purpose: The overall prognosis of oncology patients admitted to intensive care has improved~     greatly in recent years, leading to a wider admission policy. Due to a decrease in mortality~     in intensive care, more and more patients returning oncological circuit for the continuation~     of treatment of the underlying disease The existence of sequelae after the ICU (Intensive~     Care Unit) stay, whether renal, cardiac, respiratory or other, may influence the continuation~     of the optimal anti -cancer treatments and thus reduce the chances of recovery or evolution~     without tumor progression. However, no studies have evaluated the effects of resuscitation on~     subsequent cancer treatment strategies. It would thus become better appreciate the long-term~     oncology patients discharged alive from the hospital after a stay in intensive care.~      Main purpose of research :~      Assess the feasibility of a anti-tumor therapy for patients with progressive solid tumors,~     after an intensive care stay for other reason than elective surgery monitoring or securing an~     invasive procedure. The possibility of making an anti -cancer treatment will be evaluated by~     the treating oncologist and classified total, partial or absent from that defined before or~     during the ICU stay~      Secondary objective of the research :~      Evaluate the percentage of patients discharged alive from the ICU and dying in the hospital.~      Evaluate survival, lifestyle and physical and psychological effects of these patients after~     discharge from the hospital over a period of one year. It is understood that all these~     secondary endpoints will interfere with the existence of an evolutionary neoplasia not only~     with the ICU stay. They will therefore be interpreted with caution.~      Study Type: observational Study Design: Prognostic study of routine care, national,~     prospective, cohort type ~   "
89251|NCT02398877|"~     This study evaluates the association between early trauma, depression and metabolic symptoms.~   "
89252|NCT02398864|"~     To examine whether EBUS with transbronchial needle aspiration (TBNA) can accurately and~     safely diagnose enlarged lymph nodes in the chest in patients without suspected malignancy~   "
89253|NCT02398851|"~     The overall aim of this study is to create a trans-disciplinary chronic disease continuity of~     care model with health information technology, utilizing mobile devices such as tablets,~     iPads and smartphones.~   "
89254|NCT02398838|"~     This study examined the acceptability and feasibility of using a simplified regimen of~     medical abortion in the eastern and western regions of the country of Georgia. It was~     hypothesized that home use of mifepristone and buccal administration of misoprostol would be~     both acceptable and efficacious.~   "
89255|NCT02398825|"~     This study aims at evaluating the efficacy of treatment with ponatinib in patients with~     chronic myeloid leukemia who are in a chronic phase and who previously received treatment~     with imatinib but resulted to be resistant to it.~   "
89256|NCT02398812|"~     The objective of this pragmatic multi-center randomized controlled trial is to test the~     effectiveness of interprofessional medication assessment in older patients needing home care~     due to their diseases or decreased functional capacity in primary care. The main hypothesis~     is that intervention has a positive impact on functional capacity and for rational and safe~     use of medicines.~   "
89257|NCT02398799|"~     The aim of this randomized controlled trial was to evaluate the effects of an integrated dyad~     care program with education and psychosocial support to patients with chronic heart failure~     and their partners during a post-discharge period after acute deterioration of heart failure.~      Methods: One hundred fifty five patient-caregiver dyads has been randomized to usual care or~     a psycho-education intervention delivered in three modules through nurse-led face-to-face~     counseling, computer-based education and other written teaching materials to assist dyads~     develop problem-solving skills. Follow-up assessments has been completed after 3, 12 and 24~     months to assess perceived control, perceived health, depressive symptoms, self-care,~     knowledge, caregiver burden and health care utilization.~   "
89258|NCT02398786|"~     The Myotonic Dystrophy Family Registry (MDFR) is an online, patient-entered database that~     collects information on myotonic dystrophy (DM) to aid researchers in developing new,~     effective treatments and help identify participants for research studies and clinical trials.~   "
89259|NCT02398773|"~     This phase II trial studies F-18 16 alpha-fluoroestradiol (FES) positron emission tomography~     (PET)/computed tomography (CT) in predicting response to endocrine therapy in patients with~     newly diagnosed breast cancer that has spread to other parts of the body. FES is a~     radioactive form of the hormone estrogen and may light up where cancer is in the body.~     Diagnostic procedures using FES, such as FES PET/CT, may help measure the FES and help~     doctors predict how well the cancer will respond to treatment.~   "
89260|NCT02398760|"~     Nowadays, the research priority in low back pain area have been find subgroup of patients~     with the same characteristics that might achieve better outcomes in a specific intervention.~     However, even though the studies in this area have increased, questions of this nature~     remaining without an adequate answer, or with limited evidence. Therefore, the investigators~     propose to examine the ability of clinical tests, developed to assess alterations related to~     clinical lumbar instability, to identify subgroups of patients with non specific chronic low~     back pain that may have better outcomes after a motor control exercises intervention.~   "
89261|NCT02398747|"~     The primary objective of this study is to investigate the safety and tolerability of~     continuous and/or intermittent dosing of AZD2014 when given orally to patients with advanced~     solid malignancies.~   "
89262|NCT02398734|"~     SONOBIRDIE Trial is a randomized, single-blind, sham-controlled study designed for a~     demonstration of the safety and effectiveness of sonolysis (continual transcranial Doppler~     monitoring) in reduction of risk of stroke or transient ischemic attack (TIA), brain~     infarctions and cognitive decline using a 2-MHz diagnostic probe with a maximal diagnostic~     energy on the reduction of risk of brain infarctions by the activation of endogenous~     fibrinolytic system during carotid endarterectomy (CEA) in patients with ≥ 70% symptomatic or~     asymptomatic internal carotid artery stenosis.~      The sample size is based on an expected 2.5% reduction of stroke or TIA during the 30-day~     postoperative period in the sonolysis group (estimated prevalence, 1.5 %) compared to the~     control group (estimated prevalence, 4 %). Pre-study calculations showed that a minimum of~     704 patients in each group is needed to reach a significant difference with an alpha value of~     0.05 (two-tailed) and a beta value of 0.8 assuming that 10 % would be lost to follow-up or~     refuse to participate in the study.~      Consecutive patients will be assigned to the sonolysis or control group by a~     computer-generated 1:1 randomization. In patients randomized into sonolysis group, middle~     cerebral artery segment in a depth of 55 mm will be continuously monitored during~     intervention using a diagnostic 2-MHz transcranial Doppler probe with a maximal diagnostic~     energy.~      In patients randomized into control group, the transcranial Doppler probe will be fixed in a~     required position using a special helmet as in sonolysis group patients, but middle cerebral~     artery segment in a depth of 55 mm will be only localized using a diagnostic 2-MHz~     transcranial Doppler probe with a maximal diagnostic energy and the TCD monitoring will be~     stopped afterwards.~      Confirmation of the investigators hypothesis that sonothrombolysis is able to activate~     endogenous fibrinolytic system during CEA with consecutive reduction of stroke or TIA, and~     the number and volume of brain infarcts, can lead to the increase of the safety of CEA in~     patients with internal carotid artery stenosis. The investigators can presume that up to 50%~     of patients indicated for CEA can be treated using these methods in the future.~   "
89263|NCT02398721|"~     Ideally randomized controlled trials should be carried out to compare the cost-effectiveness~     between FNAC and watchful waiting but such studies are very difficult to conduct in practice~     because they require following up very large number of subjects for a long period of time.~      The aims are to determine the health-related quality of life (HRQOL) and HRQOL preference~     (utility) of patients undergoing watchful observation (no FNAC) and routine FNAC, and to~     determine the cost-effectiveness of two strategies in managing small incidental thyroid~     nodules for the Chinese population in Hong Kong.~   "
89264|NCT02398708|"~     The purpose of this study is to examine the gut bacteria, levels of peripheral blood~     inflammation markers, and symptoms in patients with and without chronic graft-versus-host~     disease (cGVHD) following allogeneic hematopoietic stem cell transplant (allo-HSCT). The~     hypothesis is that individuals with cGVHD will have lower levels of microbial diversity,~     higher levels of inflammatory metabolites in stool and peripheral measures, and higher levels~     of symptoms than individuals without cGVHD.~   "
89265|NCT02398695|"~     The fact that dental caries remains a major public health problem mandates that oral-health~     researchers explore new strategies for assessment of caries risk, as well as for caries~     prevention and management. Dental caries occurs when acids produced by bacterial glycolysis~     of dietary carbohydrates causes demineralization of the tooth enamel. A major focus of caries~     research has been on identifying and characterizing acid-generating bacteria and the~     mechanisms of acid resistance. The purpose of this study is to investigate over time the~     relationship between alkali production and caries.~   "
89266|NCT02398682|"~     The study pilots an outreach service for Acute kidney injury (AKI) patients, based on~     electronic alerts. Using the alerts we will contact the primary clinician caring for the~     patient with AKI in the Intervention group. The study has a control group of patients~     receiving good standard care, but without Outreach. The aim is to reduce morbidity and~     mortality in the syndrome, and also to reduce healthcare costs.~   "
89267|NCT02398669|"~     Study will evaluate the pharmacokinetics (PK), safety and tolerability of a single 10 mg dose~     of lorcaserin hydrochloride in obese pediatric subjects 6 to 11 years of age.~   "
89268|NCT02398656|"~     This trial will enroll patients that have been diagnosed with a transient ischemic attack~     (TIA) or minor stroke that has occurred within the past 12 hours. Anyone diagnosed with a~     minor stroke faces the possibility of long-term disability and even death, regardless of~     treatment. Stroke symptoms such as weakness, difficulty speaking and paralysis may improve or~     worsen over the hours or days immediately following a stroke. TEMPO-2 is a minor stroke trial~     for patients presenting within 12 hours of their symptom onset. Patients will be randomized~     to TNK-tPA or standard of care. In the intervention group TNK-tPA is given as a single,~     intravenous bolus (0.25mg/Kg) immediately upon randomization. Maximum dose 50mg. The control~     group will receive antiplatelet agent(s) as decided by the treating physician. Antiplatelet~     agent(s) choice will be at the treating physician's discretion.~      TEMPO-2 Coordinating Centre is located in Calgary, AB, Canada. There will be approximately 50~     sites participating worldwide.~      Dr. Shelagh Coutts is the Principal Investigator.~   "
89269|NCT02398643|"~     Chronic obstructive pulmonary disease (COPD) is a chronic lung disease primarily caused by~     smoking. COPD creates a tremendous burden to the healthcare system, as disease exacerbations~     result in frequent, prolonged hospitalizations. While originally considered a disease~     specific to the lung, data has shown that COPD is associated with substantial cardiovascular~     (CV) morbidity and mortality. Exacerbations of COPD requiring hospitalization result in~     marked patient deterioration, and heightened CV risk. The cause of the increased CV risk with~     stable COPD, and the exaggerated CV risk during exacerbations of the disease are unknown;~     however, it may be due to chronic inflammation which is exacerbated with a flare-up of the~     disease, and/or chronic inactivity which is similarly worsened with bed-rest during a~     hospitalization. Despite the impact of COPD on healthcare, there are relatively few studies~     examining how COPD inpatient care impacts on patient outcomes, inflammation and CV risk.~     Disease management programs, such as pulmonary rehabilitation and patient self-management~     education, are part of guideline therapy for COPD; however, these are not regularly~     implemented following a hospitalization, and how these interventions affect patient outcomes,~     behavior, physical activity, inflammation and CV risk have not been well studied. The~     proposed long-term project will examine how early referral to chronic disease management~     programs after hospital discharge, affect patient outcomes. This study will provide~     invaluable information about outpatient management for a disease which has a tremendous~     impact on healthcare.~   "
89270|NCT02398630|"~     Abstract:~      Recent advances in reproductive medicine have generated a demand for more accurate imaging~     methods for identifying the specific cause of female infertility and other gynecologic~     disorders. Virtual hysterosalpingography is an emerging modality in which aspects of the~     established technique of hysterosalpingography are combined with the cutting-edge technology~     of multidetector computed tomography (CT) to allow a comprehensive and highly accurate~     evaluation of both the female reproductive system and the pelvic anatomy generally. Unlike~     ultrasonography (US) and magnetic resonance (MR) imaging, multidetector CT is capable of~     depicting both the external and internal surfaces of the uterus, fallopian tubes, and other~     pelvic organs, providing high-resolution data that are suitable for two- and~     three-dimensional reconstructions and virtual endoscopic views. Thus, virtual~     hysterosalpingography may prove to be superior to other noninvasive modalities for evaluating~     tubal patency. Moreover, in comparison with conventional hysterosalpingography, which may~     involve cervical clamping, virtual hysterosalpingography is painless. Because of the health~     risks associated with ionizing radiation, the use of another modality (eg, MR imaging, US)~     may be preferred if the presence of a focal uterine lesion is strongly suspected. However,~     virtual hysterosalpingography with multidetector CT may provide a diagnostic advantage in~     complex cases.~   "
89271|NCT02398617|"~     Heart failure is a chronic and frequently terminal illness associated with poor quality of~     life and high burden of morbidity, re-hospitalization, and cost. Accordingly, recent~     guideline updates have highlighted the need for improved focus on end-of-life and palliative~     care of advanced heart failure patients, in whom symptom burden can be high and treatment~     options are often limited. The aims of this study are to evaluate the feasibility of~     implementing a semi-structured, outpatient, nurse practitioner-led, educational supportive~     care intervention concerning multiple domains of end-of-life care not often included in~     regular, outpatient clinic visits.~   "
89276|NCT02398552|"~     Sunitinib given at 50 mg/day on schedule 4/2 (4 weeks on treatment, 2 weeks off) is the~     standard care for first-line treatment of metastatic renal cell carcinoma, but the schedule~     was reported with a high rate of dose reduction and dose discontinuation because of the~     safety profile. So investigators conducte this randomized, multi-center phase II study to~     determine whether a sunitinib regimen of 50 mg/day 2-weeks on/1-week off could provide the~     same efficacy in terms of progression-free survival, objective response, and overall~     survival, while reducing drug-related toxicity.~   "
89277|NCT02398539|"~     This protocol describes a randomized, two arm clinical trial comparing two topical treatments~     in patients with hypergranulation tissue at gastrostomy tube sites. The subjects are~     randomized to either group 1or group 2 treatments:~      Maximum duration of therapy is 4 weeks. However, the therapy may be discontinued anytime at~     the discretion of the investigator or if there is resolution of the of the hypergranulation~     tissue.~   "
89278|NCT02398526|"~     This observational prospective single arm cohort study is designed to assess pain and bone~     pain related quality of life of metastatic Castration Resistant Prostate Cancer (mCRPC)~     patients receiving Radium-223 in a real life nuclear medicine practice setting. In addition,~     overall survival, time to next tumor treatment (TTNT), time to first symptomatic skeletal~     event (SSE), course of blood counts, and safety will be assessed.~   "
89279|NCT02398513|"~     The primary objective of this study is to define the pharmacokinetic of Regorafenib~     administered orally as a single agent in Chinese patients with advance solid tumors.~      The second objective include the evaluation of safety, tolerability, and efficacy of Chinese~     patents treated with Regorafenib~   "
89280|NCT02398500|"~     The purpose of this first-in-human study is to evaluate the safety and tolerability of single~     ascending doses of LMG324 to determine the maximum tolerated dose (MTD) in neovascular~     age-related macular degeneration (nvAMD) subjects. Enrollment will be expanded at a safe and~     tolerated dose in treatment naïve nvAMD subjects to compare a single intravitreal (IVT) dose~     of LMG324 to ranibizumab 0.5 mg administered every 4 weeks for change from baseline in~     best-corrected visual acuity (BCVA) at Week 12 (Day 85).~   "
89281|NCT02398487|"~     This is a pilot study to compare efficiency and tolerability of a personal vaporizers (PV)~     new generation electronic cigarette loaded with nicotine e-liquid with cigalike new~     generation electronic cigarette loaded with nicotine and usual smoking habits, in a group of~     well characterized regular smokers unwilling to quit.~   "
89282|NCT02398474|"~     Iliac crest bone graft harvest is associated with acute pain that can lead to chronic~     postoperative pain. Local anesthetic infiltration and regional anesthesia could be of~     interest to reduce opioid consumption during and after surgery, reduce hyperalgesia and the~     associated risk of chronic postoperative pain. In this surgery, local anesthetic infiltration~     of the iliac crest is associated with a pain reduction compare with placebo.~      Some studies have shown the benefit of a TAP (transversus abdominal block) for postoperative~     analgesia after iliac crest bone graft harvest. The TFP block (transversalis fascia plane~     block) has been recently described. Considering the nerves trajectories, the TFP block is~     probably anatomically the most appropriate block for analgesia after iliac crest bone graft~     harvest.~      The aim of this study is therefore to assess the benefit of an ultrasound TFP block for~     analgesia after iliac crest bone graft harvest compare with local anesthetic infiltration~     Design is prospective, randomized, double blind, controlled study~   "
89283|NCT02398461|"~     This is a Phase 1, multi-center, double-blind, randomized, placebo-controlled,~     dose-escalation study in subjects with relapsing Multiple Sclerosis (MS). The primary outcome~     will be the safety and tolerability of a single dose of rHIgM22 in relapsing MS subjects.~   "
89284|NCT02398448|"~     The purpose of this study is to determine whether defined and limited changes in in vitro~     dissolution impact the in vivo pharmacokinetics (PK) and relative bioavailability of~     allopurinol and the active metabolite oxypurinol.~   "
89285|NCT02398435|"~     The objective of this study is to assess safety, tolerability and early signs of efficacy of~     the investigational drug Tadekinig alfa in Adult-onset Still's disease, a rare polygenic~     auto-inflammatory disorder for which treatment remains empirical.~      This disease is characterized by a daily spiking fever, arthralgia / arthritis, and skin~     rashes with frequent components of sore throat, lymphadenopathies and neutrophilic~     leukocytosis. The etiology is unknown. In addition to the above-mentioned clinical features,~     the diagnosis includes some laboratory components that reflect the systemic inflammation:~     high erythro-sedimentation rate, C-reactive protein, high serum ferritin and high levels of~     interleukin 18 (IL-18).~      Tadekinig alfa is the drug name for recombinant human interleukin-18 binding protein~     (IL-18BP). This investigational drug was tested in healthy volunteers, psoriasis and~     rheumatoid arthritis patients in phase I studies. It demonstrated good safety and~     tolerability profile with only mild adverse events in the injection site.~   "
89286|NCT02398422|"~     A research project funded by the Reiss-Davis Child Study Center of Vista Del Mar (RDCSC/VDM)~     will be conducted on the Vista Del Mar campus of the RDCSC/VDM to evaluate the effectiveness~     of the Listening Project Protocol (LPP) in children who have difficulties with autonomic and~     behavior regulation in the classroom. The LPP is designed as a neural exercise to reduce~     auditory hypersensitivities, to improve auditory processing of speech, and to improve~     behavioral state regulation. The LPP uses acoustic stimulation to exercise the neural~     regulation of the middle ear structures to rehabilitate and to normalize the acoustic~     transfer function of the middle ear structures. The current study is being conducted to~     evaluate efficacy and feasibility of the LPP with emotionally disturbed and learning~     challenged young people and will use objective measures to evaluate changes in acoustic~     transfer function of the middle ears structures, auditory processing skills, physiological~     state regulation, sensory symptoms, and academic pre and post testing.~   "
89287|NCT02398409|"~     The purpose of this study is to determine the effectiveness of the ANSWERS- VA intervention~     (Acquiring New Skills While Enhancing Remaining Strengths for Veterans) while also~     determining it's cost effectiveness in the stroke and traumatic brain injury (TBI)~     populations.~   "
89495|NCT02395692|"~     This phase II trial studies how well methoxyamine works when added to standard temozolomide~     in treating patients with glioblastoma that has come back. Drugs used in chemotherapy, such~     as methoxyamine and temozolomide, work in different ways to stop the growth of tumor cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading.~   "
89288|NCT02398396|"~     This study will be an open label, exploratory immunogenicity study conducted by the Oxford~     Vaccine Group, University of Oxford. This study will investigate the breadth of protective~     activity of serum anti-FHbp antibody responses of adults immunized with 4CMenB (Bexsero®)~     vaccine as well as investigating the nature of the B-cell and T-cell responses induced by~     vaccination.~      The investigators aim to enroll 15 to 20 healthy adults aged 18 to 60, who will be immunized~     with two doses of 4CMenB (Bexsero®) two months apart according to the licensed schedule.~     Blood samples will be obtained at baseline and after each dose of vaccine.~   "
89289|NCT02398383|"~     This project is designed to begin to characterize the abnormalities of glucagon secretion in~     subjects with cystic fibrosis related diabetes along the spectrum of glucose tolerance.~     Cystic fibrosis patients with normal glucose tolerance as well as cystic fibrosis related~     diabetes as well as control subjects will undergo an oral glucose tolerance test, mixed meal~     tolerance test, and one step hypoglycemic clamp. Cystic fibrosis patients will then return 12~     months later to undergo repeat mixed meal tolerance test and hypoglycemic clamp test.~   "
89290|NCT02398370|"~     Prospective, open-label, non-randomized, study to be conducted at a single center. Ten~     subjects will undergo an injection of Placental Matrix-Derived Mesenchymal Stem Cells~     (PMD-MSCs) into the penis for the treatment of mild to moderate erectile dysfunction. Follow~     up visits will be conducted at 6 weeks, 3 months, 6 months, and 12 months. Subjects will be~     evaluated for re-injection beginning at 3 months. Eligibility is determined by the clinician~     based on patient reported treatment satisfaction.~   "
89291|NCT02398357|"~     To determine the effect and safety of anticoagulation after endoscopic therapy in cirrhotic~     patients with portal vein thrombosis and to explore whether it can decrease the short-term~     rebleeding rate.~   "
89292|NCT02398344|"~     Previous studies found important function of brain in exercises regulation on healthy and~     athlete patients and this studies showed not invasive stimulation on temporal cortex brain,~     induces electrics field to insula cortex, in addition modulate autonomic nervous system~     cognition efforts during submaximal (maximal hight frequency) and maximal exercises. Measure~     immediate effects of transcranial stimulation in bloodstream (tDCS) anodic on right and left~     temporal cortex in the cardiorespiratory parameters (functional capacity, perception of~     efforts and modulation of autonomic nervous system) in patients with hemiparesis due stroke.~     Methods and Material: It Is a clinical trial, controlled and Double blind, using 30 adult~     patients with stroke sequel, like roam. Evaluation will be hemodynamic measure data such as:~     Heart Rate, Respiratory Rate, Blood Pressure, Lung Capacity Vital and assessment of the~     Autonomic Nervous System, before and after anodic electro stimulation from bloodstream on~     right and left temporal cortex region (T3 area) and cathodic position in contralateral~     supraorbital region to anode (Fp2). On temporal cortex will be applied of 2mA during~     stimulation of 20 minutes. Sham stimulation all electrodes Will be used. The stimulator turns~     on for 30 seconds. Results: The primary results will analyze cardiac frequency before and~     after tDCS and second step will assess the travelled distance on walking test for 6 minutes~     with and without tDCS and compare these respiratory reviews results with stroke gravity.~   "
89293|NCT02398331|"~     The purpose of this study is to assess the impact on sexuality in women with a spinal cord~     injury, twelve months after their first return to home, of a program including structured~     information and education on sexuality, delivered 6 months after their first return to home.~   "
89294|NCT02398318|"~     Refractory obsessive-compulsive disorder (OCD) is a disabling condition. Deep brain~     stimulation (DBS) of the nucleus accumbens is the most tested therapeutic avenue for~     refractory OCD. However, large scale randomized controlled trials to evaluate the~     effectiveness of this approach are rare.~   "
89295|NCT02398305|"~     To obtain arterial access for a diagnostic cardiac catheterization or percutaneous coronary~     intervention (PCI) the cardiologist can choose between the femoral artery and the radial~     artery. In the University Medical Center Groningen the femoral artery is commonly used. After~     intervention the puncture site is closed with an arteriotomy closure device (ACD). Patients~     after radial access receive a pressure bandage at the puncture site, usually the Terumo (TR)~     wrist bandage.~      The bedrest period for patients with an ACD is 1 hour after diagnostic cardiac~     catheterization and 2 hours after PCI. After the bedrest period patients are discharged 1~     hour after diagnostic procedures or 4 hours after PCI. This to observe potential bleeding~     complications after the procedure. In patients with radial access, the TR bandage will be~     removed according to current protocol after 4 hours and additionally 1 hour observation is~     required. Several cardiologists have the intention to use the radial artery more frequent for~     cardiac catheterization or PCI. In a meta-analysis radial access is related to a 73% decrease~     in major bleeding complications compared to femoral access. Also there are no significant~     differences in MACE. Even so there are no differences in success percentage for cardiac~     catheterization or PCI and admission time is shorter for radial access (Am Heart J. 2009~     Jan;157(1):132- 40). Admission time for diagnostic cardiac catheterization at the short-stay~     unit is in case of femoral access with an ACD approximately 2 hours. For patients after~     radial access post procedural admission time is approximately 5 hours. To guarantee patient~     throughput, uniformity of care and more efficient use of capacity of the short-stay unit,~     patients after radial access should not have a longer hospital admission time than patients~     after femoral access. Carrington et al. (J Interv Cardiol. 2009 Dec;22(6):571-5) have shown~     that it is safe to deflate the TR wrist band faster than four hours.~      Objective of the study:~      To describe the differences in safety, patient comfort and admission period after diagnostic~     cardiac catheterization through radial access, between the current protocol and the protocol~     of fast desufflation by Carrington et al.~   "
89296|NCT02398292|"~     The purpose of this study is to determine the feasibility (≥ 50% completion rate) of a 6-week~     nutrition, movement, and mindfulness program for youth with recent diagnosis of psychosis.~   "
89297|NCT02398279|"~     This study evaluates the addition of L-Arginine to the usual regimen in the treatment of~     schizophrenia in adults. As a requisite of crossover design, half of the participants started~     with L-Arginine and the other half with placebo and switched over after a three weeks use and~     one week of a washout period.~   "
89298|NCT02398266|"~     The measurement of limb skeletal muscle perfusion and perfusion reserve during exercise is an~     approach that can assess the total impact of the complex pathophysiologic processes in~     patients with limb ischemia, particularly in those with diabetes in whom distal arterial~     disease and abnormal microvascular functional responses are common. This trial is designed~     to: (a) optimize methods for assessment of limb perfusion at rest and during stress using~     contrast-enhanced ultrasound (normal subjects) and a microbubble contrast agent that is able~     to provide non-linear signal without destruction at medium acoustic pressures, and (b) to~     test whether perfusion imaging provides incremental information on the severity of disease in~     patients with peripheral artery disease.~   "
89299|NCT02398253|"~     The purpose of this study is to assess the effects of CBT after a successful weight loss by a~     comprehensive weight loss plan on weight maintenance in obese female adults.~   "
89300|NCT02398240|"~     The addition of Brentuximab vedotin (Bv) to combination chemotherapy will be safe, well~     tolerated and effective in children, adolescents and young adults with all stages of newly~     diagnosed Hodgkin lymphoma (HL).~   "
89302|NCT02398214|"~     Sleep problems during infancy are associated with behavior and emotional problems, poor~     language development , parental distress and mood disturbances, and overweight and obese~     children. The investigators proposed that children who receive the light, activity, and sleep~     training (LAST) intervention program in this study will have less parent report of problem~     sleep behaviors and longer duration of nighttime sleep compared to children with no~     intervention provided.~   "
89303|NCT02398201|"~     The purpose of this study is to gather preliminary data on whether bezafibrate can improve~     cellular energy production in mitochondrial disease.~      Mitochondrial diseases are rare inherited disorders that arise due to deficient energy~     production within the cells of the body. Consequently, the typical clinical features arise in~     organs with high energy requirements. Mitochondrial disorders exhibit highly variable~     clinical effects, both between individuals and within families. Characteristic symptoms~     include muscle weakness (myopathy), hearing loss, migraine, epilepsy and stroke like episodes~     in addition to diabetes and heart problems. Mitochondrial disorders can therefore impact~     considerably on both quality of life and life expectancy. Despite this, no proven disease~     modifying treatments are available.~      Pre-clinical studies have identified that several existing medications improve mitochondrial~     function. Of these, bezafibrate has the best supportive data and, because it is already~     licensed as a treatment for high blood fats, has a well characterised side effect profile.~      The investigators will therefore conduct a feasibility study of bezafibrate in people with~     mitochondrial myopathy. Ten affected participants will be recruited and will receive a~     titrating course of bezafibrate three times daily for 12 weeks.~   "
89304|NCT02398188|"~     This is a multi-center, randomized, double-blinded, placebo-controlled study evaluating the~     safety and efficacy of LIPO-202 for the reduction of central abdominal bulging due to~     subcutaneous fat in non-obese subjects.~   "
89305|NCT02398175|"~     The present study predicts that concomitant chest injuries in polytraumatized pediatric~     patients are a potential source of substantial morbidity and mortality.~   "
89306|NCT02398162|"~     This is an observational study of the natural immune response to scrub typhus in patients~     recruited from Chiangrai Prachanukroh Hospital, N-Thailand. Febrile patients with a positive~     IgM rapid diagnostic test will be asked if they wish to take part in a study to improve the~     understanding of how the body responds to scrub typhus. Blood samples will be collected from~     each participant (STP, n=60) at baseline (the day of presentation to hospital), 2 weeks~     later in hospital, 12 weeks after baseline at the clinic visit and 1 year later. Data on~     clinical presentation and relapses will be recorded. Control subjects are scrub typhus~     exposed patients from a rural village in the caption area of Prachanukroh Hospital (STE,~     n=80; approx. 40 children and 40 adults), and healthy adults blood donors from Bangkok (STH~     n=30) - these subjects will be enrolled for one single blood sample. The study team will also~     collect eschar swab specimens from STP group and a non-invasive specimen of the dark crust on~     the day of enrollment.~   "
89307|NCT02398149|"~     Upper extremity (UE) function is critical to maintaining independence. Better understanding~     of UE involvement in MS will provide necessary information to prioritize the design and~     selection of future interventions. The goal of the proposed project is to characterize UE~     involvement in a population of community-based persons with MS across the International~     Classification of Functioning, Disability & Health (ICF) domains and constructs.~   "
89308|NCT02398136|"~     The purpose of this study is to see whether ketamine, when given repeatedly via the nose~     (intranasally), can produce a quick and persistent improvement in PTSD symptoms. At higher~     doses, ketamine has been used for many years as an anesthetic for medical procedures, and at~     lower doses may be an effective treatment in patients with major depression and PTSD.~   "
89309|NCT02398123|"~     The transversus abdominis plane (TAP) block is a relatively simple technique that provides~     myocutaneous anesthesia that, as part of a multimodal analgesic treatment, may be useful in~     the prevention and treatment of parietal postoperative pain.~      Initial experience with ultrasound TAP block demonstrated efficacy of the echo guided~     technique in different surgical procedures such as cesarean section, appendicectomy,~     laparoscopic cholecystectomy, infra umbilical surgery in adult and pediatric patients.~     Recently published clinical trials suggest that TAP block may represents an effective~     alternative to epidural anesthesia but further studies in larger population are necessary.~      Transversus-abdominis plane (TAP) block was found to increase analgesic consumption low~     thoracic-epidural analgesia (TEA) in ischemic heart disease patients after abdominal~     laparotomy (2). Others found comparable results between continuous transversus abdominis~     plane technique and epidural analgesia in regard to pain, analgesic use and satisfaction~     after abdominal surgery(3). The TAP block affords effective analgesia with opioid sparing~     effects, technical simplicity, and long duration of action. Some disadvantages include the~     need for bilateral block for midline incisions and absence of effectiveness for visceral pain~     (4). TAP block has been associated with good pain relief and decreased intraoperative and~     postoperative opioids requirements after laparoscopic surgery (5). The analgesic efficacy of~     the TAP block has been demonstrated in prospective randomized trials compared with placebo,~     in different surgical procedures such as abdominal surgery, hysterectomy, retro pubic~     prostatectomy, Caesarean section, laparoscopic cholecystectomy, and appendicectomy (6, 7, 8,~     9, 5 and 10 respectively). All these studies have reported superiority of the TAP block in~     terms of reduction in visual analogue scale scores and morphine consumption. In this study~     the investigators try to compare Transversus Abdominis Plane (TAP) blocks versus caudal block~     for postoperative pain control after lower abdominal surgeries in pediatrics.~   "
89310|NCT02398110|"~     Recent reports have suggested that transvaginal NOTES nephrectomy is feasible, yet~     comparative studies are lacking. The aim of this study was to compare the surgical outcomes~     of transvaginal NOTES nephrectomy to conventional laparoscopic nephrectomy.~   "
89311|NCT02398097|"~     Several studies have shown poor immune response to conventional influenza vaccines in~     HIV-infected individuals. This study was conducted expecting the more potent immunogenicity~     of intradermal vaccine compared with conventional intramuscular vaccine in HIV-infected~     adults.~   "
89312|NCT02398084|"~     The investigators want to understand how oral processing (chewing) of nuts affects particle~     size and the presence of lipid (fat) on the cut surfaces.~      The main objective of the study is to:~      Measure the size of nut particles that have been chewed sufficiently to be swallowed.~      The secondary objective of this study is to:~      Measure any changes in lipid content due to chewing and compare it to a prediction from a~     theoretical model.~      The investigators have developed a theoretical model for determining the release of nutrients~     from plant foods, specifically lipid (fat) from almonds. The model has been used to calculate~     the amount of lipid released from chewed almonds. The model shows that only about 10% of the~     lipid is immediately released. The investigators require information on the particle size~     distribution (number of particles of each size) for other chewed nuts to calculate the amount~     of lipid released for other nuts. This will allow us to check the validity of our model for~     other foods.~   "
89313|NCT02398071|"~     Most daily activities involve alternating periods of exercise and rest. If recovery is slow~     following exercise it means that the next period of activity may be more difficult and the~     COPD patients becomes restricted in their daily life. Therefore, the investigators are~     interested to study the effectiveness and physiological effects of breathing with a PEP~     device during post-exercise period and hypothesize that~        1. Post-exercise breathing with PEP device will increase the rate of recovery more than~          breathing without PEP device.~        2. Post-exercise breathing with PEP device will not create harmful effects on~          cardiopulmonary function in COPD patients.~   "
89314|NCT02398058|"~     This is a Phase 1b, multi-site, open-label, non-randomized clinical trial evaluating the~     safety, tolerability, and pharmacokinetics of escalating doses of olaparib and trabectedin in~     patients with unresectable advanced/metastatic sarcomas. Patients will continue to be treated~     on this combination regimen in the absence of disease progression, intolerable toxicity or~     patient's decision.~   "
89315|NCT02398045|"~     The study aims to pilot a new computerised cognitive behavioural therapy programme for a~     small case series of adults with obsessive-compulsive disorder. The investigators hypothesise~     that the findings will demonstrate improvements in symptomatology following the programme.~     The programme will have longer-term aims of being rolled out over a number of IAPT services~     within the NHS, reducing waiting lists and increasing therapist time.~   "
89316|NCT02398032|"~     Study objective: To assess the nocturnal changes in mechanosensitivity and chemosensitivity~     in hypertensive sleep apnea-hypopnea syndrome (SAHS) patients and in SAHS patients with~     isolated nocturnal hypertension. To value the continuous positive airway pressure (CPAP)~     effect on these parameters.~      Design: Controlled cross-over longitudinal study. Settings: Madrid metropolitan area.~     Patients: Day-night sustained hypertensive and isolated nocturnal hypertensive patients with~     SAHS without previous treatment. At least 30 patients are needed.~      Interventions: Patients will allocate in each treatment arm (CPAP vs. sham CPAP) during three~     months. Explorations will perform before and immediately after sleep at 0-, 3-, and 6-months~     of trial.~      Measurements: 24-h urinary catecholamine, local vascular factors, angiotensin and aldosterone~     levels. Diaphragmatic tension-time index, metabolic rate, hypoxic withdrawal test, and~     ventilatory and inspiratory neural drive responses to progressive isocapnic hypoxia.~   "
89317|NCT02398019|"~     Patients whom require cardiopulmonary bypass (CPB) during surgery present systemic~     inflammatory response syndrome (SIRS) due to blood cell activation and cytokine release to~     circulation. SIRS can lead to organ dysfunction due to hemodynamic compromise (vasodilatation~     plus leak syndrome) and/or cytokine mediated cell injury. Renal dysfunction is a major~     adverse complication after CPB surgery. Investigators hypothesize that the use of an~     increased adsorption membrane (OXIRIS®) during CPB is safe and presents low technical~     complexity. The safe use of OXIRIS® will reduce both cytokine circulatory levels and~     lipopolysaccharide (LPS) circulatory levels therefore decreasing SIRS and its systemic~     effects specially those concerning renal function. Therefore, patients receiving (OXIRIS®)~     could potentially present less postcardiac surgery acute kidney injury (pAKI), lower~     intensive care unit (ICU) and hospital length of stay, and lower production of renal injury~     biomarkers (cell-cycle-arrest-proteins) tissue inhibitor of metalloproteinase-2 (TIMP-2) and~     insulin growth factor binding protein-7 (IGFBP-7).~   "
89318|NCT02398006|"~     Background: Fracture of the clavicle is common accounting for 2.6% to 4 % of all fractures,~     with an overall incidence of 36.5 to 64 per 100,000 per year. Around 80% of clavicle~     fractures occur in the middle third of the clavicle. There is a lack of evidence of~     randomised controlled trials assessing the best treatment of these fractures. The objective~     of this study is to evaluate the effects (benefits and harms) of conservative interventions:~     figure-of-eight bandage versus sling for the treating middle third clavicle fractures.~     Methods/Design: this project has been designed as a single-centre, parallel-group randomised~     controlled trial that will compare figure-of-eight bandage versus sling. The investigators~     aim to recruit 110 adults, aged 18 years or older, with an acute (less than 10 days) middle~     third clavicle fracture. Primary outcomes will be function or disability measured by DASH~     questionnaire; the secondary outcomes will be: modified UCLA score pain, treatment failure,~     adverse events and numbers returning to previous activities. Data analysis: the chi-square~     test will be used to analyse the results of categorical variables, and Student t-test will be~     used to compare groups with respect to the numerical variables. The Student t-test is used to~     compare the clinical outcome of each group at 1, 2 and 4 weeks and at 6 and 12 months after~     the intervention. The significance level of 5% (alpha = 0.05) is used for all statistical~     tests such that tests have a value of less than 0.05 are considered statistically~     significant. Discussion: According to current evidence there is very limited evidence from~     two single trials only regarding the effectiveness of different methods of conservative~     interventions for treating clavicle fractures. This study is one of the first randomised~     controlled trials following the CONSORT statements designed to compare two conservative~     methods for treating clavicle fractures (figure-of-eight versus sling).~   "
89319|NCT02397993|"~     Endoscopic ultrasonography (EUS ) -guided fine needle aspiration (EUS -FNA ) of focal~     pancreatic lesions is an essential diagnostic procedure with high therapeutic effect in~     clinical routine.~      The aim of this study is to determine the levels of serum lipase, serum amylase and the tumor~     marker CA 19-9 prior and after EUS-FNA. In animal experiments on dogs, an increase of all~     three parameters was observed after surgery on the pancreas. For humans, these clinically~     important data are not yet available .~      It is assumed that the probability of pancreatitis with increased activity of lipase and~     amylase will rise with the number of puncture procedures as well as the size of the puncture~     needle. In addition, the post-interventional assessment of the tumor marker CA 19-9 could~     result in a false positive assumption of malignant neoplastic pancreatic lesion.~   "
89320|NCT02397980|"~     The purpose of this study is to investigate if behavioral intervention for dementia~     caregivers will decrease caregiver burden in caregivers of patients with dementia. This~     multicenter, randomized trial will be conducted with 80 dementia caregivers, who will be~     randomized into two groups. One group consists of 40 participants who will receive behavioral~     intervention and 40 who will not receive intervention (waitlist control). The waitlist~     control group will be also provided the same intervention after the intervention group has~     completed the intervention. The behavioral intervention consists of 90-min-session a day with~     an interval of two weeks for 2 months. The primary outcome measures are the changes in scores~     of Zaret's Burden Inventory and Philadelphia Geriatric Center for Moral Scale (PGCMS).~   "
89321|NCT02397967|"~     A national, multicenter, randomized, transverse clinical trial, estimating the existence of~     phonological deficits in children with NF1 children compared with control children without~     NF1 with the same reading level.~   "
89322|NCT02397954|"~     The objectives of this study are to evaluate the safety and tolerability of Zimura®~     intravitreous injection in combination with anti-VEGF therapy in subjects with Idiopathic~     Polypoidal Choroidal Vasculopathy (IPCV).~   "
89324|NCT02397928|"~     The study is a prospective, single arm, non-randomized, open label phase II trial, designed~     to study the safety and efficacy of a medical device, the NovoTTF-100L concomitant with~     Pemetrexed and cisplatin or carboplatin in Malignant Pleural Mesothelioma patients. The~     device is an experimental, portable, battery operated device for chronic administration of~     alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by~     means of surface, insulated electrode arrays.~   "
89325|NCT02397915|"~     The purpose of this study is to provide information on whether subjects with allergic~     rhinitis (AR) prefer the administration of fluticasone furoate (FF) nasal spray or mometasone~     furoate (MF) nasal spray based on how the products feel to the subjects when administered.~      This Phase IV interventional study is a multi-center, randomized, double-blind, single-dose,~     cross-over subject preference study to evaluate and compare patient preference for FF [(total~     dose of 110 microgram (mcg)] and MF (total dose of 200 mcg) nasal sprays in subjects with~     allergic rhinitis. These two commonly used nasal sprays use different actuation systems (FF~     nasal spray is side-actuated; MF nasal spray is top-actuated) and this study will evaluate~     whether this difference is reflected in the patient-assessed attributes of the two nasal~     sprays. The attributes or properties which are being assessed by the subjects for these nasal~     sprays include smell, taste & aftertaste, drip down the throat, run out of the nose, urge to~     sneeze, and irritation.~      The single-day study per subject comprises screening and all treatments and procedures.~     Eligible subjects will be randomized 1:1 to a cross-over treatment schedule so that all~     subjects receive both products. One group of subjects will have two sprays of FF administered~     in each nostril whilst a second group will have two sprays of MF administered into each~     nostril. At 30 (± 5) minutes after the first study medication treatment, the two groups will~     switch. The first group will then have two sprays of MF administered into each nostril and~     the second group will then have two sprays of FF administered into each nostril. After each~     treatment the subject will complete two sets of attributes questionnaires ('immediate' and~     'delayed'). A subject-rated 'immediate' attributes questionnaire will be completed~     immediately following each treatment and a subject-rated 'delayed' attributes questionnaire~     will be completed approximately 2 minutes after each treatment. Upon completion of the second~     set of these two attributes questionnaires (immediate and delayed), a preference~     questionnaire will be completed by the subject. In the preference questionnaire, the subject~     states their preferred treatment, if any, for each of the product attributes, and finally~     states their overall preferred treatment, if any.~      There will be follow-up contact with the subject 24 (± 4) and 96 (± 4) hours after~     administration of the last treatment. The study is planned to enroll about 300 subjects.~   "
89326|NCT02397902|"~     The specific aim of the proposed study is to address the efficacy of conventional full-fat~     dairy products as part of the normal routine diet for improving vascular function and~     reducing blood pressure in middle-aged and older adults with elevated blood pressure. The~     investigators hypothesize that dietary intervention including whole milk and full-fat milk~     products will induce significant decreases in systolic blood pressure and arterial stiffness.~     The investigators also test the hypothesis that the reductions in blood pressure will be~     associated with the corresponding decreases in arterial stiffness and/or increases in~     endothelial vasodilatory function as well as improvements in arterial baroreflex sensitivity.~     If our hypotheses are supported by the results, the information could be used as a basis for~     recommendations for the use of whole milk and full-fat milk products in the secondary~     prevention of elevated blood pressure and vascular dysfunction.~   "
89327|NCT02397889|"~     The purpose of this study is to study new ways to treat post-traumatic stress disorder~     (PTSD). Current treatments for PTSD do not work for everyone and it can take time to~     determine whether a person responds to a chosen treatment. The purpose of this study is to~     see whether ketamine, when given repeatedly intravenously can produce a quick and persistent~     improvement in PTSD symptoms. At higher doses, ketamine has been used for many years as an~     anesthetic for medical procedures, and at lower doses may be an effective treatment in~     patients with major depression and PTSD. Ketamine given for PTSD is investigational, which~     means that the FDA has not yet approved the drug for treating this condition. In this study,~     the effects of ketamine will be compared to those of midazolam. Midazolam has similar acute~     anesthetic effects compared to ketamine but has not been shown to treat or alleviate any~     symptoms of PTSD. This makes midazolam an appropriate substance to gauge whether ketamine can~     treat or alleviate PTSD symptoms thereby acting as what we call an active control.~   "
89328|NCT02397876|"~     Cow's milk (CM) allergy is the most common food allergy in children, affecting 2-3% of~     infants. In formula-fed infants with CM allergy, extensively hydrolyzed or amino acid-based~     infant formulas are typically recommended. These formulas are expensive and not palatable.~     For older patients with CM allergy, the standard of care is avoidance of all CM products. The~     investigators cared for a CM allergic patient who was able to tolerate partially hydrolyzed~     whey formula (pHWF), which tastes better and is less expensive than extensively hydrolyzed or~     amino-acid based formulas. There are likely other subjects who could similarly tolerate pHWF.~     Furthermore, it is possible that taking pHWF could accelerate tolerance of CM. The~     investigators aim to identify characteristics of CM allergic subjects who can tolerate pHWF~     and assess the degree to which taking pHWF accelerates CM tolerance.~   "
89329|NCT02397863|"~     This open-label, multi-center study is open to patients 1 to 18 years of age at time of~     enrollment with medication resistant epilepsy.~   "
89330|NCT02397850|"~     There is a high risk for relapse in people suffering from depression. Studies indicate that~     the continuation of an acute psychotherapeutic treatment can reduce the likelihood of~     relapse. Therefore, this pilot study is aimed to investigate the feasibility of a~     continuation psychotherapy over 6 months, to support people suffering from chronic forms of~     depression in their daily life. The investigated continuation therapy itself includes about~     one telephone call per month (therapist - patient), focussing on the integration of~     strategies into the patient's daily routine. The patients receive either 30 minutes or 50~     minutes phone calls. On the one hand, these phone calls are supported by a workbook for~     patients containing psychoeducative elements, strategies and exercises. On the other hand,~     the therapist's work is based on a manual containing several modules and strategies. Both~     tools (workbook, manual) are understood as a framework, using the appropriate sections~     according to the patient's needs. As a result, the patients receive a continuation treatment~     which is appropriate and adapted to their individual situation.~      The main purpose of this pilot study is to evaluate the feasibility of a telephone based~     psychotherapeutic continuation treatment with a small sample of 20 patients suffering from~     chronic depression. In case of promising results the effectiveness of this kind of treatment~     is going to be investigated within a comparative trial (including face-to-face intervention,~     no intervention).~   "
89331|NCT02397837|"~     Converging evidence suggests that patients with bipolar disorder suffer from deficits in~     neurocognitive functioning that persist, despite remission of acute affective symptoms. These~     impairments contribute directly to functional disability, highlighting the need for~     interventions above and beyond standard treatments in order to achieve a full inter-episode~     recovery. The current study aims to investigate the safety and efficacy of a dopamine agonist~     (pramipexole), on these persistent cognitive abnormalities in euthymic bipolar patients using~     a placebo-controlled, adjunctive, 12-week trial design.~   "
89332|NCT02397824|"~     OroDental anomalies are one of the phenotypical aspects of at least 900 rare diseases or~     syndromes affecting by definition less than 1 in 2000 individual within the population~     (almost 25 million persons in Europe).~      They are often described in association with other organs or system malformations, which is~     understandable, because the same genes and signalling pathways regulate the oral cavity~     formation or odontogenesis and the development of other organs. The various dental and~     orofacial anomalies can be classified by type (anomalies of tooth number, shape, size,~     structures of mineralized tissues, eruption, resorption, tumors; anomalies of oral mucosa;~     anomalies of tongue…), by signalling pathways and by syndrome families.~      These anomalies (for example hypodontia/oligodontia, amelogenesis imperfecta, dentinogenesis~     imperfecta…) become increasingly identified as diagnostic and predictive traits. Not only is~     it important to recognise, name appropriately and integrate these dysmorphic clues into the~     patient dysmorphology analysis but it is essential to synthesize the observations and~     confront them to existing data about similar orodental anomalies encountered in some of the~     corresponding mutant mouse models.~      Translational approaches in development and medicine, are relevant to gain understanding of~     molecular events underlying clinical manifestations and to enhance diagnostic accuracy.~      The aim of this study is to improve the knowledge, diagnosis and care of oral cavity~     pathologies encountered in rare diseases via the identification and gathering of national and~     international patient cohorts and to structure the molecular diagnosis behind these~     conditions via targeted next-generation sequencing assays. Data collection is implemented on~     validated accredited tools (databases) complying with the legal regulations about patient~     data protection and medical record collection. All information is anonymized.~      New effective diagnosis and therapeutic tools are being developed.~   "
89333|NCT02397811|"~     Human crossover pharmacokinetic study involving 12 subjects to determine the relative~     bioavailability of astaxanthin in six commercially available oral formulations.~   "
89334|NCT02397798|"~     The purpose of this study is to examine whether person-centered high-intense aerobic /~     strength training during five months reduces inflammation and disease activity, improve~     immune cell function, and increases muscle strength, fitness and ability of the individual~     independence in elderly patients with rheumatoid arthritis.~   "
89335|NCT02397785|"~     The goal of the study is to evaluate the use of a personal intravaginal, non- implanted~     electrical stimulation device in the treatment of chronic pelvic pain. The investigators~     propose a randomized controlled trial comparing the investigated device to a sham device. The~     primary outcome is pain control using the visual analog scale and brief pain inventory (18).~     Hypothesis: Subjects will report increased pain relief with the electrical stimulation device~     compared to those using the sham device alone.~   "
89336|NCT02397772|"~     The mainstay of control of soil-transmitted helminths (STH) is school-based deworming but~     recent modelling has highlights that in all but low very transmission settings, the treatment~     of school-aged children is unlikely to interrupt transmission, and that new treatment~     strategies are required. This study seeks to answer the question: is it possible to interrupt~     the transmission of STH and if so, what is the most cost-effective treatment strategy and~     delivery system to achieve this goal? In this study, two paired community cluster randomised~     trials in different settings in Kenya will evaluate the impact and cost-effectiveness of~     annual school-based deworming, annual community-based deworming, and biannual community-based~     deworming. The interventions are (i) annual mass anthelmintic treatment delivered either to~     pre-school and school-aged children, as part of a national school-based deworming programme,~     or to the entire community delivered by community health workers. The primary outcome measure~     is the prevalence of hookworm infection (the most common STH species), assessed by periodic~     cross-sectional, age-stratified parasitological surveys. Secondary outcomes include intensity~     of hookworm, prevalence and intensity of Ascaris lumbricoides, treatment coverage, and among~     a randomly selected sub-sample of participants who will be followed longitudinally, worm~     burden and proportion of eggs unfertilised. A nested process evaluation, using~     semi-structured interviews, focus group discussions and a stakeholder analysis will~     investigate the community acceptability, feasibility given the local and regional health~     system structures and processes, and scale-up of the interventions.~   "
89337|NCT02397759|"~     The subarachnoid hemorrhage (SAH) from ruptured aneurysm is a situation that is~     life-threatening, which is largely dependent on the occurrence of vasospasm from the 4th day~     after the bleeding. This vasopasm is responsible of clinical morbidity in 30 to 50% of~     patients. It occurs in 40% of patients with severe SAH.~      Despite knowing this, the clinician has no biomarker for identifying patients at risk.~      The project presented is original and includes a screening method without a priori to~     identify predictive biomarkers of vasospasm, likely to become therapeutic targets. In~     secondary objective we will focus on the protease activity of cerebrospinal fluid (CSF) and~     blood as a biomarker potential of vasoconstriction at the waning of subarachnoid hemorrhage.~      This study will take place over a year prospectively. The inclusion of patients will be in~     the SAR 1 Hospital of Timone. Patients with severe severe SAH by rupture requiring the~     establishment of an external ventricular derivation (EVD) will be divided into two groups and~     compared to one group of patients without necessitating a EVD subarachnoid hemorrhage.~        -  Group 1: Patients with vasopasm~        -  Group 2: Patient presenting no vasopasm Detection of vasopasm was defined using a~          consensual definition. CSF samples (through EVD) and blood will be made upon arrival of~          the patient in intensive care and then between the 3rd and 4th day.~      As the main criterion, we will identify biomarkers of vasospasm in blood and CSF without a~     priori assumption by metabolomics. Analysis will be by chromatography system coupled to a~     high resolution mass spectrometer. This method does not justify effective calculation because~     it is a step of generating hypotheses requiring further biological validation based on the~     identified targets.~      The secondary criteria, we will study in the blood and CSF association between matrix~     metalloproteinases (MMP) 2 and 9 and the occurrence of vasopasm.~      RESULTS: After comparative analysis of groups 1 and 2 in two phases of the study, we will~     define a metabolic profile that could identify predictive biomarkers vasopasm.~   "
89338|NCT02397746|"~     MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to~     evaluate the safety and efficacy of its total hip arthroplasty (THA) European Union (EU) .~     These types of studies are required by regulatory authorities for all THA devices that do not~     have clinical evidence available at the time of gaining approval to market in the EU. This~     study has been designed in accordance with MEDDEV 2.12/2 rev 2.~   "
89339|NCT02397733|"~     The main objective of this study i sto evaluate the impact of prophylactic cranial~     irradiation (PCI) with hippocampal avoidance in the neurocognitive function and quality of~     life of small cell lung cancer patients.~      In addition, the trial assesses the potential changes in hippocampal volumetry due to cranial~     irradiation using magnetic resonance imaging.~   "
89361|NCT02397447|"~     The hypoglycemic effect of Momordica Charantia has been evaluated in clinical trials in~     patients with type 2 diabetes mellitus. Important reductions in fasting plasma glucose,~     glycated hemoglobin (A1C), and fructosamine were observed. It is unknown whether this~     improvement is due to an improvement in insulin sensitivity and insulin secretion. The~     purpose of this study is to evaluate the effect of the administration of Momordica Charantia~     on insulin sensitivity and insulin secretion in patients with type 2 diabetes mellitus.~   "
89513|NCT02395458|"~     Clinical trial to compare efficacy on eradicating Helicobacter pylori with two antibiotic~     strategies: sequential with amoxicillin and omeprazole 5 days and clarithromycin with~     metronidazole and omeprazole 5 days or omeprazole with clarithromycin and amoxicillin 14~     days.~   "
89340|NCT02397720|"~     There are 2 Arms in this study each with 2 parts. If you are eligible, you will be assigned~     to an Arm and a part when you join the study.~      Arm 1: There are 2 parts : Part A (dose escalation) and Part B (dose expansion).~      The goal of Part A of this clinical research study is to find the highest tolerable dose of~     nivolumab and azacitidine that can be given to patients with AML. The goal of Part B of this~     study is to learn if the dose found in Part A can help to control AML.~      The safety of this drug combination will also be studied.~      Arm 2: There are 2 parts: Part A (dose escalation) and Part B (dose expansion).~      The goal of Part A of this clinical research study is to find the highest tolerable dose of~     nivolumab, azacitidine, and ipilimumab that can be given to patients with AML. The goal of~     Part B of this study is to learn if the dose found in Part A can help to control AML.~      The safety of this drug combination will also be studied.~      This is an investigational study. Azacitidine is FDA approved and commercially available for~     the treatment of myelodysplastic syndrome (MDS) and it is approved as frontline therapy for~     AML in elderly participants. Nivolumab is commercially available and approved for the~     treatment of certain types of melanoma and lung cancers. Their use in this study is~     considered investigational. The study doctor can explain how the study drugs are designed to~     work.~      Up to 182 participants will take part in this study. All will be enrolled at MD Anderson.~   "
89341|NCT02397707|"~     This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single dose~     of GS-9857 in adults with normal and impaired hepatic function. Adults in the healthy control~     group will be matched to adults with impaired hepatic function by gender, age (± 10 years),~     and body mass index (± 15%).~   "
89342|NCT02397694|"~     This study will evaluate the efficacy, safety and tolerability of bictegravir (BIC) +~     emtricitabine/tenofovir alafenamide (F/TAF) fixed dose combination (FDC) versus dolutegravir~     (DTG) + F/TAF in HIV-1 Infected, antiretroviral treatment-naive adults. This study will also~     evaluate the pharmacokinetic (PK) profile of BIC, emtricitabine and TAF.~   "
89343|NCT02397681|"~     The purpose of this study is to determine the effects of procedural differences during the~     Valsalva maneuver and deep breathing test in autonomic nervous system testing.~   "
89344|NCT02397668|"~     To demonstrate the proof of principle and initial clinical safety of the CorMatrix ECM~     Tricuspid Valve and increase the efficiency of the device development process by identifying~     appropriate modifications to the implant procedure or the device.~   "
89345|NCT02397655|"~     The purpose of this multicenter study is to investigate the extra-/intra-cranial~     atherosclerosis distribution pattern in chinese populations with transient ischemic attack~     and ischemic stroke and analyze the influencing factors of atherosclerosis distribution~     pattern.~   "
89346|NCT02397642|"~     To salvage the luteal phase and improve pregnancy rate in antagonist IVF/ICSI cycles~     triggered with GnRH agonist. Two strategies are compared dual trigger with GnRH agonist plus~     1000 IU of HCG or triggering with GnRH and giving a booster dose of HCG (1500 IU) on the day~     of ovum pickup.~   "
89347|NCT02397629|"~     This is a cross sectional study to examine the relationship between serum calcium and PTHrP~     and serum PSA in men referred for prostate biopsy at Wake Forest University.~   "
89348|NCT02397616|"~     Retrospective analysis for HRM measurements using liquid swallows and a test meal for the~     presence of hiatal hernia. The investigators will correlate hernia descriptions with presence~     of acidic reflux and clinical complaints.~   "
89349|NCT02397603|"~     This study evaluates the effect of adding dexmedetomidine as an adjuvant to bupivacaine in~     patients undergoing thoracotomy when administered peri-neurally in thoracic paravertebral~     space.~   "
89350|NCT02397590|"~     A phase I clinical trial to compare the pharmacokinetics and safety of~     fimasartan/Atorvastatin combination tablet and coadministration of fimasartan and~     Atorvastatin in healthy male volunteers.~   "
89351|NCT02397577|"~     Healthy volunteers will ingest a 13C-octaoate containing test meal and 13C in expiratory air~     will be followed. Normal values will be calculated data of these tests.~   "
89352|NCT02397564|"~     The investigators will compare the efficacy of Traditional Ablative Er:YAG Versus Fractional~     Ablative Er:YAG in a split scar study. The patient will receive a month treatment for 3~     months. Then follow up for the next 2 months.~   "
89353|NCT02397551|"~     To salvage the luteal phase and improve pregnancy rate in antagonist IVF/ICSI cycles~     triggered with GnRH agonist. Two strategies are compared supplementing the luteal phase with~     three small doses (500 IU) of HCG and giving a booster dose of HCG (1500 IU) on the day of~     ovum pickup.~   "
89354|NCT02397538|"~     An Open-label, Fixed-sequence, Crossover Study to Evaluate the Pharmacokinetic Interaction~     and Safety after multiple oral doses of Fimasartan/Amlodipine and Rosuvastatin in Healthy~     Male Subjects.~   "
89355|NCT02397525|"~     Evaluate the safety of three 8-week courses of treatment with LIPO-202 in non-obese patients~     who have central abdominal bulging. Efficacy measurements will also be collected.~   "
89356|NCT02397512|"~     This study will test the influence of lactulose of the human gut microbiota. Healthy~     volunteers will ingest 50g of lactulose and donate stool samples 1 day before as well as 1-2~     days and 14 days after the test. Using sequencing and metabolomics techniques the~     investigators will identify changes in microbiota composition upon lactulose exposure.~   "
89357|NCT02397499|"~     This is a multi-center, randomized, double-blinded, placebo-controlled study evaluating the~     safety and efficacy of LIPO-202 for the reduction of central abdominal bulging due to~     subcutaneous fat in non-obese subjects.~   "
89358|NCT02397486|"~     The purpose of this study is to determine whether pentoxifylline and vitamin E are effective~     in prevention of radiotherapy- induced toxicity in head and neck cancer patients treated with~     concurrent chemoradiotherapy.~   "
89359|NCT02397473|"~     The main purpose of this study is to evaluate the efficacy and safety of the study drug known~     as LY2951742 in participants with episodic cluster headaches.~   "
89360|NCT02397460|"~     This is a double-blind, randomized, 4 period, crossover study in up to 30 male and female~     healthy and chronic cough subjects.~   "
89525|NCT02395302|"~     The purpose of the study is to assess treatment tolerance and comfort in chronic VLUs after 4~     weeks of treatment using a dual action pneumatic compression device.~   "
89362|NCT02397434|"~     A radical cystectomy + extended pelvic lymph node dissection is considered to be the~     treatment of choice for patients with muscle invasive bladder cancer (MIBC). Despite this~     aggressive treatment the outcome is poor and ultimately, 30% of the patients with ≥pT3 tumors~     develop a pelvic recurrence. One- and 2-years survival for patients developing a local~     recurrence after cystectomy is only 8% and 3% respectively, with a median survival of <4~     months. For patients with lymph node recurrence prognosis is somewhat better, but~     nevertheless still disappointing with reported 1- and 2 years survival of 42% and 11%~     respectively. The investigators hypothesize that an earlier implementation of external beam~     radiotherapy (EBRT) i.e. in the adjuvant setting, will prevent local and lymph node~     recurrence and improve disease free- and overall survival as local recurrence is linked to~     the development of distant metastasis. Adjuvant EBRT was tested in a prospective randomized~     trial and resulted in a 20% increase in 5-year disease free survival. Despite those~     impressive results, severe intestinal toxicity rates hampered the enthusiasm to use adjuvant~     EBRT, till now. In the last decade, great technological advancements in EBRT planning, such~     as intensity modulated arc therapy (IMAT), and positioning have been realised. This has~     resulted in a better coverage of the target volume while sparing normal tissue (mainly small~     bowel) and in a more precise delivery of the EBRT. Therefore, it is desirable to reconsider~     the use of adjuvant EBRT in selected MIBC patients.~   "
89363|NCT02397421|"~     Patients with diabetes are at increased risk of developing heart failure (HF) which can lead~     to increased shortness of breath, reduced ability to exercise and in some cases premature~     death as the heart becomes less efficient at pumping blood around the body. However the~     treatment options for such patients remain limited.~      This study will test the safety and benefits of using a new class of drug, the SGLT2~     Inhibitor (Dapagliflozin), in treating HF and diabetes.~      Participants will have a Magnetic Resonance Imaging (MRI) scan of the heart, to measure the~     efficiency and the extent of thickening of the heart muscle before they start on treatment of~     dapagliflozin, or placebo for one year. They will also do exercise testing on an exercise~     bike (if capable) and a walking test plus fill in some questionnaires on how their heart~     failure affects their quality of life. Participants will then continue as normal with~     currently prescribed medication for their diabetes and heart failure. After a year the tests~     will be repeated to determine if patients receiving Dapagliflozin benefited more than those~     who weren't on the drug.~      This study is funded by the European Foundation for the Study of Diabetes (EFSD)~   "
89364|NCT02397408|"~     This is a phase 2 study to assess the ability of 11C- and 18F-choline to detect and localize~     prostate cancer within the prostate gland in patients with unfavorable intermediate to~     high-risk prostate cancer (CAPRA 5-10). Secondary objectives will assess the ability of 11C-~     and 18F-choline PET/MR to detect metastatic prostate cancer within pelvic lymph nodes in~     patients undergoing radical prostatectomy and extended pelvic lymph node dissection, to~     assess the ability of 11C- and 18F-choline PET/MR to detect the specific location of~     metastatic prostate cancer within pelvic lymph node regions in patients undergoing radical~     prostatectomy and extended pelvic lymph node dissection, to determine the agreement of 11C-~     and 18F-choline PET imaging in the detection and localization of local and metastatic disease~     with other imaging techniques/methods (bone scan, CT, multiparametric 1H MRI, advanced body~     NaF PET/CT), and to determine the temporal distribution of 11C- and 18F-choline radiotracer~     in patients. The tissue uptake, retention, and clearance will be determined. An exploratory~     objective comparing regions of uptake from the 11C- and 18F-choline PET/MR and sentinel lymph~     node imaging will be performed.~   "
89365|NCT02397395|"~     The purpose of this study is to evaluate the percentage of participants with sustained~     virologic response 12 weeks after the actual end of study treatment (SVR12)~   "
89366|NCT02397382|"~     The purpose of this study is to evaluate the potential effects of a single dose of 200~     milligram (mg) guselkumab on the plasma concentrations of a cocktail of representative probe~     substrates of Cytochrome P450 isozymes (CYP3A4, CYP2C9, CYP2C19, CYP2D6, and CYP1A2) in~     participants with moderate to severe psoriasis.~   "
89367|NCT02397369|"~     Tobacco use is the single most preventable cause of premature adult death globally. It is one~     of the major causes of death and disease in India, accounting for nearly 0.9 million deaths~     every year.~      Bombay Electric Supply and Transport (BEST), one of the biggest public transport undertaking~     in Mumbai City, has imposed a ban on tobacco use in public transport buses and under Motor~     Vehicle Act has empowered the drivers and bus conductors to take suitable action against~     commuters found to be using tobacco. However in addition to commuters using tobacco in the~     BEST premises, large number of bus drivers and conductors are known to use tobacco on the~     job. There are various approaches to a tobacco cessation programme, like behavioural therapy,~     pharmacotherapy, providing self help material, telephone counseling, quit lines etc.~      Hence in terms of the workplace environment, understanding the factors leading to tobacco use~     maintenance and the effective approaches for cessation is of critical importance for~     formulating workplace tobacco prevention and cessation interventions that are applicable to~     transport work employee settings. The success of these methods needs to be comparatively~     evaluated among the different forms of tobacco users. Hence, the present study will be~     undertaken with the following objectives:~   "
89383|NCT02397161|"~     Objective: To compare the effectiveness of EEG biofeedback mental attention-neuromuscular~     training (AT-NMT), neuromuscular training (NMT) alone, EEG biofeedback mental attention~     training (AT) alone, and no intervention for improving reactive balance performance among~     children with developmental coordination disorder (DCD).~      Design: A single-blinded, randomized controlled clinical trial. Sample: 172 children with~     DCD. Interventions: AT-NMT, NMT, AT, or no intervention for 12 weeks. Major outcomes:~     Outcomes will be evaluated at baseline, post-intervention, and 3-month follow-up. A motor~     control test (MCT) will give a composite latency score, prefrontal cortex EEG recordings~     during MCT will measure the mental attention level, and surface electromyography recordings~     during MCT will indicate the lower limb muscle onset latency.~   "
89384|NCT02397148|"~     This study compares the morphological concordance between CT (computed tomography) and cone~     beam in sinus on 26 validated items. CT and cone beam is performed on each patient.~     Performances of these two imagery technics seem to be closed. Nevertheless, the exposure of~     the ionizing radiations is lower with the cone beam.~   "
89368|NCT02397356|"~     Ketamine has been administrated via the intravenous, intramuscular, subcutaneous, rectal,~     oral, transdermal, intranasal, sublingual, transmucosal, epidural, intrathecal, and~     intra-articular routes. Pharmacokinetic properties of inhaled ketamine have not been studied~     officially, but one of the investigators researchers has tested nebulized ketamine on himself~     with repeated painful stimulus and monitoring applied. Based on this experiment, analgesic~     effect is roughly estimated to begin in 3 minutes.Ketamine has been used successfully to~     treat acute pain in intranasal form. The primary purpose of this study is to evaluate whether~     nebulised S(+)-ketamine carries potential as a an analgesic bypassing first pass metabolism~     and without the need for intravenous access. Secondary aim is to assess the duration of~     analgesia obtained by nebulized S-ketamine. Thirdly, the aim is to evaluate whether inhaled~     nebulized ketamine decreases the need for rescue analgesia during PACU care. The subjects are~     recruited among patients coming in for a surgical intervention (orthopedic, gastrointestinal,~     plastic or urologic surgery) and needing further observation in postoperative care unit~     (PACU).~      It was calculated that sample size of 8 subjects per group would be required to achieve~     statistical power of 80% and detect a difference of 3 units in NRS-values with standard~     deviation of 2 units and type I error of 5%. To prepare for possible dropouts, total of 20~     subjects will be recruited (10 in each group).~      Patients will receive either nebulized placebo (i.e. saline) or ketamine (Ketanest-S) when~     they require pain alleviation in the PACU. Dosage of ketamine is 1 mg/kg. Patients will be~     randomized into two groups so that other group's first inhalation contains ketamine and~     second inhalation placebo and in the opposite order.~   "
89369|NCT02397343|"~     Hyperbaric oxygen may reduce neurophatic pain and promote wound healing. Established anti~     inflammatory effects of HBO may contribute to this effect. In a previous publication the~     investigators studied the effects of HBO on secondary hyperalgesia using a well established~     heat injury model. In a new - blinded study design, the investigators wish to investigate~     and- or confirm previous results, i.e. that HBO therapy reduce secondary hyperalgesia and~     improving therapy of severe pain conditions.~   "
89370|NCT02397330|"~     Interscalene brachial plexus block is the gold standard for perioperative pain management in~     shoulder surgery. However, this technique would have side effects and potential serious~     complications. The aim of this study is to compare between the combination of ultrasound~     guided suprascapular and supraclavicular nerve blocks versus ultrasound guided interscalene~     brachial plexus block for post operative analgesia after shoulder instability surgery with~     latarjet procedure.~   "
89371|NCT02397317|"~     The SPARK trial is testing the use of Kilovoltage Intrafraction Monitoring in prostate cancer~     patients being treated with Stereotactic Prostate Adaptive Radiotherapy. The researchers~     expect this trial to result in better targeted prostate cancer patient outcomes with lower~     toxicity. The potential application of Kilovoltage Intrafraction Monitoring to other tumour~     sites will pave the way for additional trials with Australasian radiation oncology leading~     the world.~   "
89372|NCT02397304|"~     Obesity is a major public health issue and its association with insulin resistance greatly~     increases risks for cardiovascular disease and type 2 diabetes. Exercise training is~     recommended for obese populations, but longitudinal studies indicate aerobic exercise~     training in obese individuals in the absence of weight loss has minimal impact on insulin~     resistance. High turnover of fat stored within muscle cells (i.e., intramyocellular~     triglyceride) during exercise and elevated muscle fitness (i.e., muscle oxidative capacity)~     are key features of the enhanced insulin sensitivity observed in endurance-trained~     individuals. It could be that longitudinal studies of exercise training in obese individuals~     failed to sufficiently stimulate intramyocellular triglyceride turnover during exercise and~     muscle oxidative adaptation as a result of failure to consider the impact of recent nutrition~     within their study designs. Performing exercise in the fed vs. fasted state can blunt these~     exercise responses in non-obese individuals. The researchers will investigate the hypothesis~     that an acute bout of aerobic exercise performed in the overnight-fasted versus fed-state can~     stimulate greater intramyocellular triglyceride utilization during exercise and enhanced~     expression of genes related to muscle oxidative adaptation in obese individuals. The expected~     outcomes will help to determine if exercising in the fasted state could be used to optimise~     metabolic adaptation to training in obese individuals. The future impact of this research~     could be the recommendation of a simple nutritional strategy considering meal timing to~     enhance the effects of aerobic exercise training in obese individuals, with potential~     long-term benefits for reducing insulin resistance and cardio-metabolic disease risk.~   "
89373|NCT02397291|"~     The purpose of this study is to determine whether the transplacental gradients for 6 polyols~     and mannose are altered in intrauterine growth restricted (IUGR) pregnancies compared to~     normal pregnancies and b) to determine the relative contributions of transplacental transport~     vs production by the conceptus of both inositol (the major polyol) and mannose in IUGR and~     normal pregnancies using stable isotopic methodology.~   "
89374|NCT02397278|"~     This study plans to learn more about ways to treat a joint problem in the knee called~     Juvenile Osteochondritis Dissecans (OCD). The goal of this study is to see if injecting~     platelet-rich plasma (PRP) into the knee can help knee cartilage heal faster, and will try to~     determine whether the injections lead to improvements in pain, performance of activities of~     daily living, improvements is sports activities and overall function and symptoms reduction.~     The investigators will compare PRP treatment to conservative therapy.~   "
89395|NCT02397005|"~     The first-in-man study are designed as below to assess safety, tolerability, and preliminary~     pharmacokinetics of ZL-2102.~        -  Double-blind randomized, placebo-controlled ascending single oral doses (Part 1,~          ZL-2102-SAD);~        -  Open-label, randomized, 2-sequence, 2-period, 2-treatment crossover (Part 2,~          ZL-2102-FED);~        -  Double-blind randomized, placebo-controlled, ascending repeated oral doses for 14 days~          (Part 3, ZL-2102-MAD).~      A total of 104 subjects will be enrolled.~   "
89526|NCT02395289|"~     The purpose of the study is to examine the effects of cognitive-based compassion training~     (CBCT), a meditative practice based on Buddhist teachings, on long term emotional well-being~     and immune system improvement with people living with Human Immunodeficiency Virus (PLHIV).~   "
89585|NCT02394522|"~     The primary objective of the study is to demonstrate and quantify the protective efficacy~     (PE) of spatial repellent products in reducing the incidence of malaria infection in human~     cohorts. The null hypothesis (H0) is that there is no difference in malaria incidence between~     intervention and control arms.~   "
89375|NCT02397265|"~     The diabetes technology group at Imperial College have developed a bio-inspired artificial~     pancreas (BiAP) system which uses a control algorithm based on a mathematical model of~     beta-cell physiology. The algorithm is implemented on a miniature silicon microchip within a~     portable handheld device, which interfaces the components of the artificial pancreas.~      Development of closed-loop insulin delivery devices to intensify control without~     hypoglycaemia has been extensively reviewed and have shown encouraging results . However,~     they have not yet proven to be robust when challenged with uncertainty and the external~     challenges (such as mixed meal contents, physical exercise, physiological stress and~     intercurrent illness) that people with Type 1 Diabetes Mellitus (T1DM) may be exposed to~     outside the clinical environment.~      The principal research objective is to assess the safety and efficacy of a closed-loop system~     for T1DM compared to standard insulin pump therapy (open-loop). The primary outcome from the~     studies will be % time spent with a glucose concentration in the target range~     (3.9-10.0mmol/l). This outcome incorporates safety as it ensures subjects do not have low or~     high glucose excursions and is the principal measure of efficacy for closed-loop insulin~     delivery systems in the scientific literature. Other measured outcomes will be % time spent~     in euglycaemia (3.9-7.8mmol/l), % time spent in hypoglycaemia (<3.9mmol/l), % time spent in~     hyperglycaemia (>10mmol/l), mean venous blood and sensor glucose, glycaemic variability as~     measured by standard metrics (Standard Deviation, Continuous Overlapping Net Glycaemic~     Action, Lability Index, J-Index, Glycaemic Risk Assessment Diabetes Equation, Mean Of Daily~     Differences, Mean Amplitude of Glucose Excursion, Average Daily Risk Range, M-VALUE, Mean~     Average Glucose), glycaemic risk as measured by Low Blood Glucose Index (LBGI) and High Blood~     Glucose Index (HBGI), closed-loop error grid analysis, glucose area under the curve. All~     measures have been previously published and validated.~      This clinical trial protocol assesses the artificial pancreas system in three separate~     sub-studies:~        1. In a bi-hormonal (insulin and glucagon) configuration~        2. During and after exercise with bi-hormonal closed loop, and standard insulin opened loop~        3. During and after meals of mixed composition with bi-hormonal closed loop, and standard~          insulin opened loop~   "
89376|NCT02397252|"~     The proposed study seeks to compare the diagnostic performance of Human Papillomavirus (HPV)~     testing in self-collected samples via the Eve Medical self-collection system© (Eve) with~     standard physician-collected samples for the detection of cervical intraepithelial neoplasia~     grade 1 or worse (CIN1+) and cervical cancer among women referred for colposcopy. The~     performance of the Eve sample will also be compared with that of a second self-sample via a~     cobas® PCR Female swab.~      Approximately 1000 adult women with an abnormal Pap test at the level of an atypical squamous~     cells of undetermined significance or worse squamous or glandular abnormality (i.e., ASCUS+)~     or an abnormal co-test (ASCUS+ and HPV-positive) result will be recruited over a period of 12~     months via colposcopy clinics located at the Jewish General Hospital, St-Mary's Hospital, and~     the McGill University Health Centers (Royal Victoria Hospital).~      Participating women will undergo three cervical or cervicovaginal sampling techniques: 1)~     self-sampling using the Eve Medical self-collection system©; 2) self-sampling using a cobas®~     PCR Female swab; and 3) physician-collected sampling. The participants will also fill in a~     questionnaire on their experience with the convenience and acceptability of the Eve system,~     relative to the other two sampling approaches. The decision as to which self-sample is to be~     collected first will be dependent on randomization~      HPV testing will be done using the cobas® 4800 HPV Test. The liquid medium of within the~     cobas® PCR CELL Collection Media with the provider collected sample and the cobas® PCR media~     with the two self-collected samples will be used to suspend the cellular material prior to~     HPV testing. We have made collaborative arrangements with Dr. Marcel Behr, Chief of the~     Department of Clinical Microbiology at the McGill University Health Centre for the HPV~     genotyping work.~      Histology-confirmed CIN1+ will form the study outcome or case definition. Sensitivity,~     specificity, and predictive values (along with their respective 95% confidence intervals)~     will be calculated for each sample type to evaluate the clinical performance of the various~     sampling techniques. We will use CIN1+ as definition of disease but analyses will also be~     performed for more stringent definitions, e.g. CIN2+ or CIN3/cancer.~   "
89377|NCT02397239|"~     Protocol title:~      Comparison of cost-effectiveness of continuation maintenance therapy with six cycles of~     pemetrexed versus pemetrexed until disease progression for metastatic non-squamous~     non-small-cell lung cancer (NSCLC)~      Study design:~      An open-labelled, randomized, phase 2 trial~      Indication:~      Patients with stage IV non-squamous NSCLC, an Eastern Cooperative Oncology Group (ECOG)~     performance status of 0-1, and have received first-line or second-line chemotherapy with~     pemetrexed plus platinum for 4 cycles~      Treatment:~      Maintenance pemetrexed 500 mg/m2 every 3 weeks for six cycles versus until disease~     progression~      Objectives:~      Primary endpoint:~      1. Progression-free survival in the intention-to-treat population~      Secondary endpoints:~        1. Cost-effectiveness~        2. Overall survival~        3. Quality-of-life (QoL)~        4. Quality-adjusted progression-free survival (QA-PFS)~        5. Quality-adjusted life expectancy (QALE)~        6. Tumor response rate~        7. Adverse events~      Planned sample size:~      36 patients in each arm; total 72 patients~      Total number of sites:~      1 site~      Duration of patient enrollment:~      3 years~   "
89378|NCT02397226|"~     200 patients with insufficient great saphenous veins will be randomized to either~     radiofrequency ablation or high ligation/stripping (open surgery). They will be examined~     according to standardized examination protocol Venous Clinical Severity Score (VCSS), with~     duplex ultrasound and plethysmography pre- and postoperatively (1-month, 1-, 3 and 5 years).~     They are to fill questionnaires EuroQol 5 Dimensions (EQ-5D) and disease specific Aberdeen~     Varicose Vein Questionnaire (AVVQ).~   "
89379|NCT02397213|"~     The purpose of this study is to evaluate the potential of ciclosporin in reducing risk and~     degree of acute kidney injury after cardiac surgery.~   "
89380|NCT02397200|"~     Study design:~      Double blind, randomized, placebo controlled study. Participants will be randomly assigned~     either to the intervention group or the placebo control group. Randomization for the two~     study groups will be made in a ratio of 1:1.~      The primary objective of the study is to assess the effect of 6-12 months treatment with~     nutritional supplementation standardized formula, in short and lean female adolescents on~     weight Standard Deviation Score (SDS) and height SDS The Secondary Objectives of the study~     are to assess the effect of 6-12 months treatment with nutritional supplementation~     standardized formula, in short and lean female adolescents on BMI SDS, growth velocity, time~     to puberty, quality of life and self-esteem The study will continue for 6 months of~     intervention versus active placebo, with additional optional 6 months (an extension period),~     in which participants at both groups, the intervention and the placebo, will be offered to~     continue their participation in the study with the study supplement. All analyses of the~     effect's on primary and secondary outcome measurements will take into account the consumption~     rate of the study formula/placebo~   "
89381|NCT02397187|"~     The assessment of the efficacy of a structured, dimension-based, STI (Short Term~     Intervention) in de-compensated Personality-disorder, hospitalized, patients~   "
89382|NCT02397174|"~     Polycystic ovary syndrome (PCOS) is the most common endocrinopathy of reproductive-aged women~     that manifests itself with chronic anovulation, hyperandrogenism and insulin resistance.~     Available guidelines recommend lifestyle intervention although they do not suggest the best~     dietetic regimen for the treatment of PCOS. Thus, the purpose of this study is to compare the~     effectiveness of two nutritional protocols, namely Mediterranean Diet and Hypocaloric Diet in~     PCOS women.~   "
89445|NCT02396342|"~     This study evaluates how safe gene therapy treatment with AAV5-hFIX is in adult patients with~     severe or moderately severe hemophilia B and severe bleeding type.~   "
89446|NCT02396329|"~     There is no difference between using chlorhexidine-based antisepsis protocol versus~     povidone-iodine protocol in reduction of surgical site infection in women undergoing cesarean~     section.~   "
89385|NCT02397135|"~     IVF (in vitro fertilization) cycles fails more often than they succeed. Surprisingly very~     little effort is invested in defining the reasons for failure and possibly finding ways to~     improve the success on the next cycle. The investigators believe that the main reasons for~     failure are related to oocyte quality and indirectly to the follicle response for a~     particular patient. The investigators have developed a panel of biomarkers to assess the~     faulty follicular conditions leading to lower oocyte quality. Using these markers would~     indicate if a given cycle was characterized by over growth, over-luteinization, early or late~     trigger. Indeed our transcriptomics analysis has identified biomarkers of follicles still in~     their growth phase at trigger or follicles that have already begun luteinisation compare to~     follicle that are at the optimal level of differentiation. Measuring these biomarkers would~     allow making a better diagnostic for a given patient and potentially explaining reasons for~     failure. The system would also become adjustable to variable COS (control ovarian~     stimulation) and individual clinical practices. It is important to realize that this is~     applicable to almost all cycle failure and can be done on a pool of follicular cells when~     none of the oocytes obtained has led to a pregnancy. This does not resolve uterine problems~     but often these are caused by hormonal conditions established by the ovary or the ovarian~     treatment. This technology can be applied in all IVF clinics as no special equipment is~     required. It would be particularly valuable in clinics where a number of cycles is limited~     due to funding, or in clinic where a package of 3 cycles is proposed to the patient. The~     patient interest to have a custom treatment increases at each failing cycle as well as the~     doctors' interest to succeed. This technology is not clinically validated yet and would~     require a period of testing where participating clinics will collect the samples for a~     retrospective analysis (presence of biomarkers of follicular problems vs outcome) then in a~     prospective analysis where the diagnostic is used in a sub-set of patient to modulate the~     second/third cycle compared the outcome to patient with no diagnostic. The increase in~     pregnancy rate or cumulative pregnancy rate should reach a minimum of 10 and 25 %~     respectively to indicate a significant value.~   "
89386|NCT02397122|"~     The aim of the trial is to evaluate the effectiveness of coronally advanced flap~     (CAF)+connective tissue graft(CTG)+platelet-rich fibrin(PRF) combination in Miller I and II~     recession treatment by comparing with CAF+CTG. 40 patients were surgically treated either~     with CAF+CTG+PRF (test group) or CAF+CTG (control group). Clinical parameters of plaque index~     (PI), gingival index (GI), vertical recession (VR), probing depth (PD), attachment level~     (AL), keratinized tissue width (KTW), horizontal recession (HR), MGJ localization (L-MGJ),~     tissue thickness (TT) were recorded at baseline, 3 months (PS1) and 6 months (PS2)~     post-surgery. Root coverage (RC), complete RC (CRC), attachment gain (AG), and keratinized~     tissue change (KTC) were also calculated.~   "
89387|NCT02397109|"~     The dysthyroid orbitopathy (DO) is a chronic disease, evolving during 2 to 3 years, with a~     hypertrophy and a variable degree of inflammation of the eyelid muscles, the oculomotor~     muscles and the orbital fat.~      If the diagnosis of OD is primarily clinical and laboratory, MRI is an additional~     contribution to the clinic, guiding the therapeutic management by detecting inflammatory~     lesions not found on clinical examination in 1/3 of cases.~      The three MRI sequences conventionally practiced ((T2, T2-fat-sat, T1) allow muscles signal~     analysis oculomotor abnormalities as well as the orbital fat.~      Compared to these sequences, the main advantage sequences DIXON is a faster acquisition. In~     addition, DIXON type of imaging overcomes most of these artifacts and to obtain a homogeneous~     fat removal.~   "
89388|NCT02397096|"~     The study will evaluate the safety and efficacy of a switch to MK-1439A (MK-1439 [doravirine]~     plus lamivudine and tenofovir disoproxil fumarate) in HIV-1-infected participants~     virologically suppressed on a protocol-specified antiretroviral regimen. The primary~     hypothesis is that a switch to MK-1439A will be non-inferior to continuation of the regimen~     at Screening for 24 weeks, as assessed by the proportion of participants maintaining HIV-1~     ribonucleic acid (RNA) <50 copies/mL. The Base Study will last up to 50 weeks.~   "
89389|NCT02397083|"~     You are being asked to take part in this study because you have endometrial hyperplasia (a~     pre-cancerous growth of the lining of the uterus) and/or early-stage endometrial cancer.~      The goal of this clinical research study is to learn if the Mirena intrauterine device~     (levonorgestrel IUD), alone or in combination with everolimus, is effective for the treatment~     of endometrial hyperplasia and/or early-stage endometrial cancer.~      This is an investigational study. The levonorgestrel IUD is commercially available and FDA~     approved as a form of birth control. The use of the IUD itself to treat endometrial cancer is~     investigational. Everolimus is FDA approved and commercially available to treat kidney,~     breast, and pancreatic cancers. The combination of everolimus and the levonorgestrel IUD in~     this study to treat endometrial cancer is investigational.~      Up to 270 patients will be enrolled in this study. Up to 250 will take part at MD Anderson~     and up to 20 will take part at the Harris Health System.~   "
89390|NCT02397070|"~     This study evaluates the effect of jaw exercise therapy in the treatment of temporomandibular~     disorder patients (TMD). An eligible group of patients will be treated with that therapy~     (experimental group) and another group will be treated with counseling and occlusal splint~     (control group), considered the standard therapy for TMD.~   "
89391|NCT02397057|"~     This will be a Phase III, double blinded, multi-center, randomized, placebo-controlled study.~     Eligible subjects will be randomized in a 1:1 ratio to receive Injectafer or Placebo on days~     0 and 5. All treated subjects will be followed for efficacy and safety for 12 months. The~     subject's participation in the study will be for approximately 1 year from Day 0.~   "
89392|NCT02397044|"~     The purpose of this study is to compare the success rates of two surgical protocols. One~     protocol will have the implants placed at the time of tooth extraction and placed into~     function. The other protocol will have the implants placed into healed extraction sites and~     placed into function.~   "
89393|NCT02397031|"~     The purpose of the study was to determine whether mindfulness training could be more~     effective than another active intervention in reducing borderline personality disorder (BPD)~     symptoms. The main hypothesis was that patients allocated to the mindfulness group would show~     a greater improvement on global BPD symptomatology. As a second objective, we explored some~     of the possible underlying mechanisms of both active treatments. For that purpose, changes in~     decentering, mindfulness facets and cognitive processing of social interactions were also~     evaluated.~   "
89394|NCT02397018|"~     This is a phase one study investigating the safety of a single, intravenous infusion of~     banked allogeneic umbilical cord blood in subjects following an acute ischemic stroke. The~     cord blood infusion must be given within 3-10 days of the stroke. Follow up phone calls will~     occur at 1, 6, and 12 months post-infusion, and will include telephone surveys on post-stroke~     rehabilitation and functioning. A follow up clinic visit at 90 days will include a~     neurological exam, MRI, and blood tests.~   "
89447|NCT02396316|"~     To assess the efficacy and safety of the administration of aflibercept by intravitreal~     injection in comparison to sham to control intraocular pressure in patients with neovascular~     glaucoma.~   "
89396|NCT02396992|"~     The purpose of this study is to apply a minimal-massive intervention (minimal recommendations~     to maximal number of patients) to elderly (>70 years) hospitalized patients with~     oropharyngeal dysphagia (OD). The intervention will consist of early screening and assessment~     of OD, malnutrition and oral hygiene. Patients will be given recommendations for adaptation~     of volume and viscosity of fluids, nutritional support and good oral hygiene practices and~     followed at 3, 6, 9 and 12 months after discharge. In every point of the follow-up period,~     patients will be re-evaluated to adjust recommendations and to verify their compliance with~     the treatment.~      The objectives of the intervention are to have an impact on complications related to OD~     (avoid impaired safety alterations and improve nutritional and oral health status and reduce)~     and to reduce readmissions, readmissions for pneumonia and morbimortality.~   "
89397|NCT02396979|"~     The purpose of this study is to evaluate the relative impact a medical drug (methadone) or~     behavioral counseling program (Holistic Health Recovery Program) or both (methadone and~     Holistic Health Recovery Program) has on reducing HIV-related risk behaviors and illicit drug~     use among opioid-dependent, HIV-infected individuals in prison when given 90 to 180 days~     prior to leaving prison.~   "
89398|NCT02396966|"~     The purpose of the protocol is to evaluate and describe QoL, in the population of Polish~     acromegalic patients treated with Lanreotide Autogel® 120 mg during the 24 months (long term~     observation).~   "
89399|NCT02396953|"~     The objectives of the protocol is to determine the maximum tolerated dose and to investigate~     the pharmacokinetics of a single dose of lanreotide PRF in subjects with acromegaly.~   "
89400|NCT02396940|"~     The aim of this study is to compare 3D-laparoscopy versus 2D-laparoscopy with the use of HD~     resolution in inguinal hernia repair in terms of error rating, performance time and~     subjective assessment.~   "
89401|NCT02396927|"~     The aim of this study is to compare 3D-laparoscopy versus 2D-laparoscopy with the use of HD~     resolution in cholecystectomy in terms of error rating, performance time and subjective~     assessment.~   "
89402|NCT02396901|"~     This is an randomised controlled trial to investigate an strategy based in a protocol in~     prevention of acute kidney injury after cardiac surgery.~   "
89403|NCT02396888|"~     Randomized, split plot, double-blind, placebo controlled trial. Half of the wounds surface~     was applied daily with insulin and the other half with saline solution as placebo. Biopsy~     specimens of the two sides were obtained on days 0 and 14. Number of blood vessels will be~     evaluated as main outcome.~   "
89404|NCT02396875|"~     Cardiac resynchronisation therapy (CRT) prolongs the life and improves the symptoms in~     patients with heart failure and electrical dyssynchrony. 30-50% of patients do not improve~     with the treatment which is both expensive and not without complication. Despite much~     research, we cannot accurately predict who will not respond. Furthermore, most heart failure~     patients gets symptoms on exercise and most studies have examined patients at rest. We~     propose to investigate the effect of exercise on different parts of the left ventricle by~     sampling various biomarkers of metabolism, myocardial injury and gene expression. We will~     then repeat the protocol following device insertion to look for changes. This novel work will~     require a small cohort of patients with heart failure and no electrical dyssynchrony and~     normal patients to act as controls. We will also measure novel biomarkers at different venous~     sites relating to different parts of the myocardium to determine whether they can be used to~     prognosticate or even predict response to CRT.~   "
89405|NCT02396862|"~     The purpose of the study is to improve the understanding of key patient reported outcomes~     such as quality of life as well as clinical outcomes in hemophilia A, in a global real world~     setting.~   "
89406|NCT02396849|"~     The purpose of this study is to see if the use of a machine called CPAP will help children~     with asthma breathe better. CPAP is a machine that produces airflow to help people with~     breathing problems. To use it, you will wear a mask connected by a hose to the CPAP machine.~     We believe that use of CPAP may be a treatment for children with asthma.~   "
89407|NCT02396836|"~     The aim is to compare the effectiveness of the 6 step hand rub technique versus 3 step hand~     rub technique in hand coverage and in reducing bacterial contamination on the hands of~     healthcare workers in practice.~      Research questions~        1. What is the effectiveness of the 6 step technique in hand coverage compared to the 3~          step technique?~             1. What are the most frequently missed sites in hand surface coverage using 6 steps~               compared to 3 steps?~             2. What is the reduction in bacterial contamination of the hand with the 6 step~               compared to the 3 step technique?~        2. Does site missed or coverage relate to bacterial load?~        3. What is the time taken for 6 step technique versus 3 step technique?~   "
89408|NCT02396823|"~     The proposed study is designed to answer a novel research question: Can resistive respiratory~     muscle training designed to improve respiratory motor control also improve blood pressure~     regulation impaired by spinal cord injury? Resistive breathing exercise, or respiratory~     muscle training, has been applied to rehabilitate breathing after spinal cord injury, but has~     not been evaluated as a method for increasing resting blood pressure and / or improving its~     regulation under stress as is planned in the proposed project. For the first time,~     respiratory muscle training intervention will be used as a tool to investigate the~     physiological relationships between pulmonary and cardiovascular function in individuals with~     Spinal Cord Injury (SCI). Thus, it will foster a new direction from which to address~     neglected issues surrounding the cardiovascular complications of spinal cord injury.~   "
89409|NCT02396810|"~     The investigators are studying the utility of intra-operative magnetic resonance imaging~     (iMRI) during transsphenoidal pituitary surgery by randomizing patients to either an~     intra-operative MRI after resection, or no intra-operative MRI. The investigators will then~     count the number of gross total resection in each group of patients and also the~     complications related to surgery.~   "
89410|NCT02396797|"~     Mental disorders is one of the most frequent causes of long-term sick leave and disability~     pensions in Norway, and there is a need for a comprehensive, coordinated response from health~     and social sectors at the country level to address the burden of mental disorders. The aim of~     this project is to investigate if a workplace intervention with the aim to increase coping of~     common mental health complaints and social support can reduce sick leave and improve health.~   "
89411|NCT02396784|"~     Early STOPP project promotes good health in children from early age by supporting good habits~     for the whole family. Our aim is to see if we can prevent overweight and obesity in children~     in families where parents are overweight or obese. Normal weight parents will also be needed~     in this study.~      Background: Several daily habits lead to less favorable health factors. For example, using~     the car instead of cycling or walking - leads to less activity in everyday life. Individuals~     also eat more unhealthy foods in larger portions. In combination with genetics, social in~     heritage and surrounding factors this contributes to increase overweight and obesity among~     children not only in adults but also in children.~      Good treatment for childhood obesity are lacking, making prevention very important. The~     earlier good habits are introduced to a child the better it is.~      In Early STOPP project we study food, physical activity and sleep habits in the families with~     a child of one year of age. The height, weight, waist circumference and blood pressure will~     be recorded in both child and parents. The parents will answer questionnaires about food,~     physical activity and sleeping habits for both the child and themselves. During the study,~     the child's physical activity will be measured. Based on our observations we aim to develop~     the preventive strategies for the families with very young children.~   "
89412|NCT02396771|"~     The purpose of this study is to compare trans-abdominal uterine massage to sustained uterine~     compression after vaginal delivery with respect to blood loss and maternal pain. It is a~     randomized controlled trial that will be conducted at the American University of Beirut~     Medical Center - Delivery Suite.~   "
89413|NCT02396758|"~     The objective of the study is to determine the optimum dose of thrombolytic and duration of~     the ultrasound procedure as a treatment for acute submassive pulmonary embolism.~   "
89414|NCT02396745|"~     This study will test the safety and effectiveness of esophageal transoral endoscopic~     circumferential resection (TECR) using an extracellular matrix (ECM) placement to treat~     Barrett's esophagus in patients with high-grade dysplasia (HGD). Endoscopic circumferential~     resection using ECM placement has been introduced as a less invasive, externally~     incision-less approach to treat patients with esophageal high grade dysplasia; a~     pre-cancerous condition. In this procedure, the entire length of diseased (abnormal) mucosa~     (esophagus lining) will be removed using an endoscope that will be inserted through the~     mouth. The ECM will be placed over the area that is being removed with a temporary,~     expandable stent to prevent narrowing of the esophagus. The stent is being used to hold the~     ECM in place as the body begins the healing process. This stent will be removed 14 days (±4~     days) after this procedure. Follow-up esophagogastroduodenoscopies (EGD), barium swallow~     x-ray tests, and questionnaires will take place for 12 months following the procedure. The~     result of this study may help doctors determine if this procedure would be a more effective~     treatment option for HGD in the future.~   "
89415|NCT02396732|"~     The purpose of this study is to determine if the addition of antiplatelet therapy (i.e.~     aspirin) to low-molecular-weight-heparin (i.e. enoxaparin) will decrease the incidence of~     venous thromboembolism (VTE) in high-risk critically injured patients. The investigators~     further aim to determine the safety and efficacy of dual thromboprophylaxis with aspirin and~     enoxaparin for decreasing the incidence of VTE after trauma.~   "
89416|NCT02396719|"~     The purpose of this study is to investigate the performance of LenSx® Laser in femtosecond~     laser-assisted cataract surgery (FLACS) in real-world medical practice in Chinese patients.~   "
89417|NCT02396706|"~     Randomized, controlled, double-blind, multi-center trial to evaluate the efficacy and safety~     of a liquid containing ivy leaves dry extract vs. placebo in the treatment of acute cough~   "
89418|NCT02396693|"~     Noninvasive ventilation has been used in preterm newborn with respiratory distress syndrome~     in an attempt to assist failure extubation. The investigators investigated failure extubation~     in infants gestational age less than or equal to 34 weeks and weights less than or equal to~     1500 grams. Neonates were randomized to noninvasive modalities support. 101 newborns were~     included in this study in three groups , group 1: Nasal Intermittent Positive Pressure~     Ventilation (NIPPV) (n=36), group 2: Nasal Continuous Positive Airway Pressure Bubble (NCPAP~     bubble) (n=33) and group 3: Nasal Continuous Positive Airway Pressure Bubble Ventilator~     (NCPAP ventilator) (n=32)~   "
89419|NCT02396680|"~     The purpose of this study is to determine the efficacy of Ragweed-SPIRE 12 months after the~     initial dose.~   "
89420|NCT02396667|"~     5D and 2D ultrasounds will be done for pregnant women with macrosomic fetuses to determine~     estimated fetal weight using hadlock formula. The accuracy of fetal weight obtained by~     ultrasound will be compared to actual birth weight.~   "
89421|NCT02396654|"~     5D and 2D ultrasound will be done to normal pregnant women between 37 to 42 weeks gestation~     and fetal weight will be estimated using the hadlock formula using biometry measured by both~     ultrasounds. Accuracy of 5D ultrasound in determining fetal weight will be determined.~   "
89422|NCT02396641|"~     The primary objective of this study is to formalize the delivery of BSC in advanced cancer~     trials. The first aim (to develop expert-derived consensus statements regarding components of~     supportive care in cancer clinical trials) and the second aim (to compare the extent to which~     documentation of current supportive care delivery in trials compares to the consensus~     statements) have been completed. The final aim of this study is to test the feasibility of~     thorough documentation of BSC delivery. That work is proposed as the primary aim of this~     study.~   "
89423|NCT02396628|"~     The preliminary data demonstrate potent activity of Ruxolitinib in steroid-refractory aGvHD.~     In this phase 2 trial the efficacy of Ruxolitinib and best available treatment (BAT) versus~     BAT in steroid-refractory acute GvHD in approximately 12 transplantation centers in Germany~     will be compared. The response by monitoring the clinical GvHD grade, requirement of~     alternative GvHD active agents and serum levels of pro-inflammatory cytokines will be~     determined.~   "
89424|NCT02396615|"~     The objective of the study is to establish whether a Pineapple juice with Viscofiber and Red~     ginseng can enhance satiety and reduce appetite and/or accelerate satiation in the~     short-term.~   "
89563|NCT02394808|"~     The primary objective of this study is to evaluate the clinical performance of two marketed~     silicone hydrogel contact lenses in an Indian population in the following areas:~     physiological characteristics, comfort characteristics and vision characteristics.~   "
89425|NCT02396602|"~     Using our experience in digital media, behavior theory, client-centered interventions, and~     family planning, we have prototyped a digital application (app)—miPlan—to be used in the~     clinic waiting room prior to a contraceptive visit. The goal of this research is to refine~     the app and conduct a randomized controlled trial of the miPlan intervention vs. standard~     care. The aim of this study is to understand miPlan's impact. The primary outcome is LARC~     uptake at clinic discharge. The secondary outcomes are contraceptive use at discharge,~     self-efficacy and decisional balance for highly effective contraception post-app use,~     contraceptive satisfaction, and intention to continue method use. The research will consist~     of baseline activities as well as a three-month follow-up call.~   "
89426|NCT02396589|"~     Stroke is one of the most serious, disabling health conditions in the United States. Patients~     who undergo rehabilitation treatment for stroke have a high rate of disability. Poor outcomes~     for many persons with stroke may be low because of incomplete treatment. The investigators~     will conduct a randomized controlled trial and a process evaluation to examine the~     feasibility, safety, and preliminary efficacy of an enhanced rehabilitation transition~     program, Community Participation Transition after Stroke (COMPASS), designed to bridge~     inpatient rehabilitation and the home to support the performance of everyday activities.~   "
89427|NCT02396576|"~     In partnership with a multi-site, Los Angeles-area community clinic consortium, North East~     Valley Health Corporation (NEVHC), the investigators will use telehealth to integrate~     pediatric developmental, behavioral and mental health (DB/MH) services into primary care for~     low-income, publicly insured children. During Project Year 1, the investigators used~     qualitative methods to conduct and analyze interviews with parents, clinicians, and staff at~     NEVHC to assess their perspectives on the delivery of child DB/MH services and on a potential~     telehealth-based patient visit, coordination, and clinician education system for the~     provision of DB/MH specialty care in primary care settings to children ages 5-12. This data~     was used in a stakeholder-engaged process to customize a telehealth-based delivery system for~     pediatric DB/MH services that can be integrated into primary care settings.~      During Project Years 2-3, the investigators will conduct a cluster randomized controlled~     trial (RCT) to compare the customized telehealth-based patient visit, coordination, and~     clinician education system to the usual in-person, community- based referral system at NEVHC.~     This study will examine whether a telehealth developmental, behavioral and mental health~     delivery model can be an effective, efficient, and family-centered way to provide integrated~     DB/MH services to children in low-income communities.~   "
89428|NCT02396563|"~     The purpose of this study is to determine if there is a difference in the duration of the~     first and second stage of labor in nulliparous women , with or without epidural analgesia.~     The investigators hypothesize that the duration of the first stage of labor will be no~     different in nulliparous patients, while the duration of the second stage will be longer in~     patient with analgesia.~   "
89429|NCT02396550|"~     Lateral epicondylalgia affects people of both gender between 1 and 3% of the world~     population, with up to 15% in the working population reaching an average of 12 weeks off work~     for this reason. One of the conservative treatments that have shown effective is the~     mobilization with movement, whose mechanisms of action are not known. According Bialosky et~     al., possible effects of manual therapy are based on the neurophysiological mechanisms at~     peripheral, spinal and supraspinal level. Among the mechanisms to supraspinal level is the~     placebo effect, which is influenced by psychological factors such as conditioning and~     expectations.~      Changing expectations to determine the influence on the treatment has been studied in healthy~     subjects, showing improvement with positive expectations and worsening to negative and~     neutral expectations.~      However the result of modifying the previous expectations for treatment in patients with pain~     has not been studied.~      The aim of our study is to test the influence that positive expectations have on the~     effectiveness of treatment with mobilization with movement in patients with lateral~     epicondylalgia.~   "
89430|NCT02396537|"~     The purpose of this study was to establish whether premedication with topical lidocaine would~     reduce the pain associated with IN midazolam administration in children. The study was~     designed to be a double-blinded, randomized, placebo-controlled trial performed in an urban,~     academic pediatric emergency department.~   "
89431|NCT02396524|"~     The Hockey Fans in Training (Hockey FIT) program aims to improve overweight men's physical~     fitness, eating habits and health-related lifestyle choices through a lifestyle modification~     program in collaboration with two Ontario Hockey League teams. In this pilot pragmatic~     randomized controlled trial, the investigators plan to explore the potential for Hockey FIT~     to reduce a clinically important amount of weight, increase physical activity levels, and~     lead to improvements in other health-related outcomes.~   "
89432|NCT02396511|"~     The purpose of this study is to determine whether TRC105 in combination with Bevacizumab is~     effective in the treatment of one patient with metastatic and refractory choriocarcinoma.~   "
89433|NCT02396498|"~     The study is designed to assess the safety and efficacy of S-1 plus cisplatin hyperthermic~     intraperitoneal chemotherapy in stage Ⅲ patients after D2 gastrectomy~   "
89448|NCT02396303|"~     Post-partum haemorrhage is one of the life threatening emergencies. It accounts for nearly~     one-quarter of all maternal death worldwide. Atonic uterus contributes about 80% among the~     causes. Uterotonic drugs are administered following the delivery of baby both in vaginal and~     caesarean delivery for prevention of PPH. However postpartum haemorrhage cannot always be~     prevented. But, the incidence and especially its magnitude can be reduced by assessing the~     risk factors and following the guidelines. The intelligent anticipation, skilled supervision,~     prompt detection and effective institution of therapy can prevent a normal case from~     undergoing disastrous consequences. This study will be carried out at Bangabandhu Sheikh~     Mujib Medical University (BSMMU) within six months after approval. This is a Randomized~     Control Trial which will compare efficacy of Carbetocin and Oxytocin for the control of PPH.~     Structured Questionnaire, Data Sheet, hospital indoor documents i.e. Patient chart, operation~     notes, surgeons visual estimation of blood loss etc will be used as study tool. Ethical~     clearance will be obtained from Institutional Review Board of BSMMU. Written informed consent~     will be obtained from the patient or from her legal guardian. Patient confidentiality will be~     strictly maintained. No name, address or contact details of the patient will be divulged.~   "
89449|NCT02396290|"~     Investigation of Clinical Effect of Platelet Rich Plasma Combined With Laser on Acne Scar~   "
89434|NCT02396485|"~     After institutional review approval, pregnant women that are scheduled for elective cesarean~     delivery will be approached for participation in the study. The study informed consent will~     be obtained. The study's time frame inclusive will be from 2013 till 2016.~      Patients will be randomized to regular diet within 6 hrs postoperative (Early group) versus~     remaining nothing per os (NPO, i.e nothing per mouth) for 12hrs, and the diet then advanced~     as tolerated after 12hrs (Routine Group) as standard postoperative protocol in the~     investigators' institution.~      Primary outcome will be time to pass flatus. Secondary outcomes will include hospital length~     of stay, postoperative nausea, vomiting and patient satisfaction. Randomization will be~     performed using a computer generated random list of numbers assigning patients to the 2~     groups of the study. This list of random number assignments will be kept secure in an opaque~     envelope until the end of the study. Patients in the Early group will be started on regular~     diet within 6 hrs of surgery, whereas the routine group patients will be kept strict NPO~     12hrs, and clear liquid diet will be started after 12hrs. Diet will be advanced as tolerated,~     i.e. if clears were tolerated or flatus or bowel movement occurred, patients will be started~     on solid foods. If diet not tolerated, a full liquid diet will be given instead. Consequently~     if patient tolerated full liquid diet, a regular diet will be then initiated. Patients will~     be discharged home only if they tolerate solid food with absence of emesis, have flatus or~     bowel movement. Time Zero is defined as time of skin incision.~   "
89435|NCT02396472|"~     People facing serious health threats increasingly use Internet health support communities to~     obtain informational support, emotional support and other resources. This study introduces~     software algorithms similar to those used by social media sites to put people in touch with~     helpful information and social interactions. Participants from the American Cancer Society's~     Cancer Support Network will have access to this online support group using the default~     interface that orders content by broad content category and date or with a new interface that~     highlights communication content and people that match users' interests and needs.~   "
89436|NCT02396459|"~     Triac Trial II will assess the effects of Triac therapy on several neurocognitive end-points~     in patients with the Allan-Herndon-Dudley Syndrome (AHDS).~      Patients with the AHDS suffer from severe psychomotor retardation. A mutation in the TH~     transporter protein Monocarboxylate transporter 8 (MCT8) results in reduced thyroid hormone~     (TH) levels in de brain, leading to an impaired neuronal differentiation. The severe~     neurological phenotype is accompanied by increased T3 levels in the blood, resulting in a~     variety of thyrotoxic symptoms such as tachycardia, increased metabolism, weight loss and a~     low muscle mass.~      Currently, Triac Trial I (NCT02060474) investigates if Triac treatment in AHDS patients~     reduces the toxic effects of the high T3 levels. In addition, the safety of Triac~     administration in AHDS patients is assessed.~      In Triac Trial II we will focus on the effects of Triac on the neurocognitive development.~   "
89437|NCT02396446|"~     This study is being conducted to determine whether providers who have access to their~     patients' acoustic intestinal rate score as calculated by an abdominal acoustic sensor that~     continuously monitors bowel sounds (AbStats) will be more likely to advance their patients'~     diets to a solid diet sooner than those who do not have access to this rate. AbStats~     calculates intestinal rates by using two small sensors placed on a patient's abdomen to~     measure and analyze their abdominal sounds.~      Patients will be asked to wear a sensor every morning for 20 minutes while they are fasting~     daily during their inpatient visit. The sensor will measure the sounds within their abdomen.~     This data will be interpreted by the AbStats device, which will provide an intestinal rate~     measurement based on the sounds recorded by the sensors.~      This intestinal rate will be provided to the patient's treating physician together with other~     vital signs. The doctor, at his/her discretion, may choose to use this information to make~     decisions about the patient's feeding status.~   "
89438|NCT02396433|"~     Non-randomized, open-label, multi-center, phase I/II, dose-escalation study of the~     combination of carboplatin, eribulin, and E7449.~   "
89439|NCT02396420|"~     The purpose of the study is to evaluate improvement in symptoms related to benign prostatic~     hyperplasia (BPH) in men treated with prostate artery embolization (PAE) using Embosphere~     Microspheres.~   "
89440|NCT02396407|"~     The purpose of this study is to measure whether a combined water, sanitation, and hygiene~     intervention leads to improved health of children who did not receive the intervention~     themselves and who live within a close vicinity of intervention recipients.~   "
89441|NCT02396394|"~     WiseMama is designed to improve our understanding of interventions that are feasible and~     effective in helping HIV-positive pregnant and postpartum women to maintain high adherence to~     antiretroviral medications. The study will involve: a) assessing the feasibility and~     acceptability of the use of an innovative pill container equipped with real-time electronic~     data monitoring capacity by HIV positive pregnant and postpartum women in Uganda; b)~     generating preliminary effectiveness data of a 2-step feedback intervention on retention in~     care, antiretroviral therapy adherence, and clinical outcomes (CD4 and HIV viral load (VL));~     c) exploring patient and provider perspectives on barriers and facilitators to retention in~     care and adherence to antiretroviral therapy in our study population.~   "
89442|NCT02396381|"~     The aim of the study is to demonstrate clinical, biological and functional health changes in~     smokers switching to the candidate modified risk tobacco product: Tobacco Heating System 2.2~     (THS 2.2) as compared to smokers continuing smoking their conventional cigarettes (CC) over a~     26-week period.~   "
89443|NCT02396368|"~     This is a Phase I/Ib study of Radium-223 in combination with Tasquinimod for patients with~     bone metastases from castration-resistant prostate cancer (CRPC).~      The investigators propose to determine the spectrum of tolerability of the combination of~     tasquinimod and radium-223 and determine a dose for a subsequent randomized phase II study~     (first cohort) and the proportion of men with bone-specific alkaline phosphatase response~     (second cohort).~   "
89444|NCT02396355|"~     The enumeration of T lymphocytes positive for the CD4 antigen is used to determine the immune~     status of patients with, or suspected of developing, immune deficiencies such as AIDS. The BD~     FACS Presto™ is an investigational automated system for in vitro diagnostic use in performing~     the direct enumeration of CD4 absolute count, CD4 percentage of lymphocytes, and hemoglobin~     (Hb) concentration in human whole blood.~      This is a prospective study to determine the relative bias between the investigational BD~     FACS Presto system and the predicate BD FACS Calibur with BD Tritest system in their~     determination of absolute CD4, % CD4, and Hb concentrations.~   "
89450|NCT02396277|"~     Immobilization after radius fracture seems to increase the risk of developing a Complex~     regional pain syndrome (CRPS), a condition associated with pain, increased skin sensitivity~     and reduced epidermal nerve density.~      The purpose of the study is to determine whether 5-week immobilisation leads to functional~     and structural sensory changes, and whether the changes are associated with persistent pain.~     The investigators plan an explorative, pilot study on six consenting patients immobilised~     after a distal radius fracture.~      The baseline measurements will be recorded at the day of or the day after trauma:~     Demographics, psychological and physical comorbidity, pain characteristics and intensity,~     hand function, health related quality of life (HRQOL), quantitative sensory testing will be~     recorded while skin biopsies are analyzed for epidermal nerve fiber density. Following~     variables such as pain characteristics and intensity, hand function, health related quality~     of life, quantitative sensory testing and skin biopsies will be reassessed when the cast is~     removed and two months later.~   "
89451|NCT02396264|"~     Polycystic ovary syndrome (PCOS) is the most common endocrinopathy of reproductive-aged women~     characterized by chronic anovulation, hyperandrogenism and insulin resistance. Available~     guidelines recommend lifestyle intervention although they do not suggest the best dietetic~     regimen for the treatment of PCOS. Thus, the purpose of this study is to compare the~     effectiveness of two nutritional protocols, namely Mediterranean Diet and standardized~     normocaloric Diet in normal weight women with PCOS.~   "
89452|NCT02396251|"~     A multi-centre, evaluator-blinded study in subjects undergoing cheek augmentation. The study~     is designed to assess efficacy with regard to aesthetic midface augmentation and safety after~     treatment with HA product.~   "
89453|NCT02396238|"~     The primary objective of this study is to assess the safety and efficacy of the Celution~     Device in the processing of an autologous graft consisting of adipose derived regenerative~     cells (ADRCs) in the treatment of hand dysfunction due to scleroderma.~   "
89454|NCT02396225|"~     Concentrations of voriconazole in pulmonary epithelial lining fluid and in serum are compared~     after inhalation of 40 mg voriconazole b.i.d. for two days or oral intake of voriconazole~     tablets 400 mg bid for 1 day followed by 200 mg b.i.d. for one day, respectively.~   "
89455|NCT02396212|"~     This is a phase III study designed to provide efficacy and safety data for canakinumab~     administered for at least 48 weeks as subcutaneous (s.c.) injection every 4 weeks (q4wk) in~     Japanese patients with Systemic Juvenile Idiopathic Arthritis (SJIA). Interim analysis (IA)~     data at Week 28 and 48 from this study will support a registration submission of canakinumab~     in the indication of SJIA in Japan.~   "
89456|NCT02396199|"~     The Zenith® p-Branch® Pivotal Study is a clinical trial approved by FDA to study the safety~     and effectiveness of the Zenith® p-Branch® endovascular graft in combination with the Atrium~     iCAST™ covered stents in the treatment of abdominal aortic aneurysms.~   "
89457|NCT02396186|"~     The purpose of this study is to collect data from real-world use with the Glider Percutaneous~     Transluminal Coronary Angioplasty (PTCA) Balloon Catheter to support the effectiveness of the~     Glider PTCA Balloon for crossing into complex coronary lesions.~   "
89458|NCT02396173|"~     Background: Orthopaedic trauma are a leading cause of long-lasting sick-leave and persistent~     disability. People suffering from persistent sick-leave often need vocational rehabilitation~     (VR). Vocational programs are planned to improve the likelihood of returning to work (RTW).~     Physical conditioning, professional evaluation and training, as well as psychological and~     social interventions are the core of the treatments. Efficiency of these programs is moderate~     and there is scope for improvements. For instance, rehabilitation programs tailored to the~     individual needs and potentials are called for. However, the allocation remains difficult.~     Decision-supportive tools may be convenient to achieve this goal. Recently, the WORRK model~     was proposed to assess early on the risk of non-returning to work for those patients. The~     main goal of this research is to measure if the WORRK model improves patients' allocation to~     different vocational programs according to their non-return to work risk.~   "
89459|NCT02396160|"~     This study aims to assess the efficacy of a specialized herbal formula, Urox, versus control~     over 8 weeks, in a double blind, placebo controlled trial. 150 participants are being~     recruited, randomized and administered treatment or placebo for the period of 8 weeks after~     initial eligibility screening. Outcome measures include previously validated tools such as~     the 3 day symptom diary measuring self-recorded day frequency, nocturia, urgency and~     incontinence episodes. Quality of life improvements are being measured using the Incontinence~     Impact Questionnaire, Urinary Distress Inventory and the short version of the OverActive~     Bladder survey.~   "
89460|NCT02396147|"~     The purpose of this study is to evaluate the oral bioavailability of two new tablet~     formulations of TAK-385 (T4 Formulation B and T4 Formulation C) under fasted and fed~     conditions, relative the T2 Formulation tablet; and to estimate the effect of food on the~     pharmacokinetics (PK) of a single oral dose of the T4 Formulation B tablet and the T4~     Formulation C tablet.~   "
89461|NCT02396134|"~     This randomized phase II trial studies how well vaccine therapy works in reducing the~     frequency of cytomegalovirus severe infections (events) in patients with hematologic~     malignancies undergoing donor stem cell transplant. Vaccines made from a peptide may help the~     body build an effective immune response and may reduce cytomegalovirus events after donor~     stem cell transplant.~   "
89462|NCT02396121|"~     The purpose of this study is to evaluate the micronutrient status of malnourished elderly~     after oral nutritional supplementation.~   "
89475|NCT02395952|"~     The purpose of this study is to compare the relative efficacy of four different treatment~     modalities (i.e. aggressive lubrication, bandage contact lens, Ambiodisk amniotic membrane,~     Prokera amniotic membrane) in the healing of persistent corneal epithelial defects following~     retina surgery.~   "
89476|NCT02395939|"~     Obtaining a tissue sample to diagnose a PPL suspected of cancerous origin is of utmost~     importance. The current gold standard; Transthoracic CT guided needle biopsy approach with a~     success rate of >90% comes at the expense of an increased side effect profile.~      Given that most lung cancers originate in the bronchus, hence named bronchogenic carcinoma,~     it would be rational to think that endobronchial route should provide the best route of~     sampling with the least amount of side effects. Radial EBUS has become popular during the~     last decade as an endobronchial modality in diagnosing PPL with minimal side effects.~     However, the yield is still not satisfactory in comparison to CT guided biopsy with only 73%~     success rate in a meta-analysis. There is also with wide variation in different centres.~      Use of a new biopsy method called cryo-biopsy using the R-EBUS guide sheath may bridge the~     gap and increase the diagnostic yield of PPL.~      Cryo biopsy had been proven to give larger sample sizes and reduced crush artefact compared~     to the conventional radial EBUS biopsies.~      However, there have been no head to head trials comparing Cryo-probe biopsy vs. the gold~     standard: CT guided biopsy.~      Cryo-biopsy has very favourable side effect profile without any pneumothorax occurrence. If~     the yield were to be non-inferior to CT guided biopsy this would certainly be the preferred~     choice of biopsy for PPL in the future.~      Methodology All patients with a PPL requiring a diagnostic biopsy will be eligible for~     recruitment to the trial. The recruited patients will be randomly allocated to either CT~     guided core biopsy or radial EBUS guided cryobiopsy.~      Study design Multi centre intervetional,randomised control trial.~      Study population:~      Patients diagnosed with a PPL that requires a biopsy.~      If the patient is randomised to the cryo biopsy arm:~      The procedure will be done under the usual guidelines and practice of the centre as for a~     flexible bronchoscopy procedure.~      Once flexible bronchoscopy is introduced the pre-determined desired segment, the R-EBUS is~     inserted covered by the GS.~      Once the R EBUS locates the lesion, the GS is left in situ and the USS probe is retracted.~      The cryoprobe is then inserted through the GS to the desired location. Flexible Cryoprobe~     (outer diameter 1.9mm) will be applied for 4 seconds for each biopsy. The cryogen gas used~     will be Co2.~      The probe will be retracted together with the GS and the bronchoscope en masse after each~     biopsy. A minimum of 1 and maximum of 3 samples will be taken.~      A CXR is taken within 1 hour post procedure to access for pneumothorax. Adverse events during~     the procedure will be recorded. If a chest tube placement, other investigations due to side~     effects or overnight hospital stay were to be required; all costs will be calculated~     retrospectively. Minor bleeding will not be considered an additional cost as this occurs with~     routine bronchoscopy.~      If the patient is randomised to the CT biopsy arm:~      A CT guided core biopsy will be performed as per usual practice of that centre. 2-6 passes~     will be performed for each PPL.~      A CXR 1hour post procedure will be performed to assess for pneumothorax or procedure related~     bleeding.~      If a chest tube placement, other investigations due to side effects or overnight hospital~     stay were to be required all costs will be calculated retrospectively.~      At the pathology:~      All samples will be assessed for the size of the sample and the suitability for molecular~     testing. An independent pathologist will assess samples.~      Economic analysis:~      For both procedures: Both direct and indirect costs will be calculated. The main aim of cost~     analysis is to calculate the cost of side effect management in each arm to determine the most~     cost-effective method of sampling a PPL.~   "
89496|NCT02395679|"~     Malignant mesothelioma is an aggressive pleural disease, related to asbestos exposure. At~     present, cytotoxic chemotherapy is the only evidence based treatment for the disease, but~     efficacy is limited. The investigators have shown both in a murine model, as for the first~     time in patients, that dendritic cell-based immunotherapy induces tumor specific T-cell~     responses. However the quality and quantity of the autologous tumor cell lysate to load the~     dendritic cells was a major impediment for these trials. The investigators have now developed~     a clinical grade allogeneic tumor cell lysate which can be used to load dendritic cells of~     patients.~   "
89463|NCT02396108|"~     The current standard of care for stage I-III HER2-positive breast cancer is adjuvant~     chemotherapy combined with 1 year of adjuvant trastuzumab. Neoadjuvant chemotherapy in early~     stage breast cancer has the advantages of i) tumour downsizing, ii) higher breast~     conservation rates, and iii) enabling the evaluation of tumour biology. Pathologic complete~     response following neoadjuvant chemotherapy has been shown to be an independent, strong~     predictor of outcome in operable HER2-positive breast cancer. The addition of neoadjuvant~     anti-HER2 therapy to chemotherapy results in a 2-3 fold increase in pCR rates in operable~     HER2-positive breast cancer. However, the optimal neoadjuvant regimen has not been defined in~     HER2-positive breast cancer. The investigators recently completed a phase II study of~     neoadjuvant lapatinib combined with weekly paclitaxel/ carboplatin in stage I-III~     HER2-positive breast cancer. Preliminary analysis suggested that the utility of the regimen~     might have been limited by its unfavourable efficacy/ toxicity ratio. ASLAN001 is a small~     molecule tyrosine kinase inhibitor against HER1, HER2, and HER4. Preclinical data have shown~     ASLAN001 to be more potent than lapatinib and neratinib in inhibiting HER1 and HER2, and~     early phase clinical studies have demonstrated superior pharmacokinetics and pharmacodynamic~     target inhibition compared to lapatinib. Furthermore, ASLAN001 has demonstrated a better~     safety profile than lapatinib in early phase studies.~      • The investigators hypothesize that ASLAN001 combined with paclitaxel/carboplatin will~     induce favorable pathological complete response (of at least 30%) in stage I-III HER2~     positive breast cancer, with a more favourable safety profile than lapatinib combined with~     paclitaxel/carboplatin.~   "
89464|NCT02396095|"~     Women of reproductive age who seek to freeze eggs for future pregnancy attempts may be~     eligible to participate in a study investigating pregnancies that result from frozen eggs.~   "
89465|NCT02396082|"~     This is a 24-month, prospective, single- blind, randomized controlled trial evaluating the~     MIND at Home-streamlined dementia care coordination intervention (called MIND-S) in a cohort~     of 300 community-living persons with dementia and their family caregivers in the Greater~     Baltimore area. Participants receiving MIND-S will get 18 months of care coordination by an~     interdisciplinary team comprised of trained memory care coordinators (non-clinical), a~     psychiatric nurse, and geriatric psychiatrist. The intervention involves 4 key components:~     identification of needs and individualized care planning (persons with dementia (PWD) and~     care giver (CG) needs); dementia education and skill building; coordination, referral and~     linkage of services; and care monitoring.Participants in the comparison group will receive an~     initial in-home needs assessment and will be given the written results along with any~     recommendations for care that are indicated.~   "
89466|NCT02396069|"~     Double blind, randomized, placebo control, multiple dose, dose escalation study~   "
89467|NCT02396056|"~     Guided bone regeneration (GBR) procedures have significantly evolved over the last 20 years.~     Significant advances have been made with various barrier membranes with or without the use of~     bone grafts and other materials. Some of the main limitations of non-resorbable barriers~     included cytotoxicity and need for removal, which can adversely affect the regenerated bone~     volume. Similar GBR success has been documented extensively with cell occlusive resorbable~     barriers membranes. Recently, the investigators demonstrated supracrestal bone regeneration~     in guided tissue regeneration procedures in humans with the use of novel perforated barrier~     membrane (MPM). The perforation allows mesenchymal stem cells and other progenitor cells~     present in the gingival tissues to migrate into the osseous defect and contribute to the~     osseous regeneration potential.~      The objective of this study is to investigate the GBR potential of MPM in alveolar ridge~     defects, relative to a similar occlusive barrier. Ten non-smoking patients that need~     localized alveolar ridge augmentation prior to implant placement will be included into the~     study. Patients will be divided into two groups, as follows: occlusive bovine collagen~     membrane (OM control group, 5 patients) and modified bovine perforated collagen membrane (MPM~     test group, 5 patients). All sites will be grafted with mineralized cortical bone allograft~     and when needed cortical bone pins will be use for site stability. A Cone Bean (CT) will be~     obtained prior to surgery and 6-8 months post treatment from which volumetric width changes~     will be quantify. A bone biopsy will be obtained at the time of implant placement (~6-8~     months) to determine residual graft particles and new bone formation. Dimensional width~     changes will be assess at 6-8 months during re-entry for implant placement. Soft tissue~     healing will be assessed at 2, 4, 8, 16 weeks and 6 months.~      This study can potentially impact current bone augmentation techniques and may lead to the~     modification of existing commercial membranes that will enhance site development prior to~     implant placement. The contribution of progenitor cells to the osseous defect might lead to~     greater bone formation and possible faster wound healing.~   "
89468|NCT02396043|"~     This study evaluates the efficacy and tolerability of treatment for T-lymphoblastic lymphoma~     (T-LBL) according to modified BFM-95 regimen for acute lymphoblastic leukemia.~   "
89469|NCT02396030|"~     Eclampsia is an obstetric emergency capable of prophylaxis. To prevent and control seizures,~     there is no doubt that the magnesium sulfate (MgSO4) is the ideal drug. However, there are~     still questions regarding its use and dose. The scheme and the optimal time of administration~     remain to be elucidated. The objective of this trial is to compare the effectiveness and~     safety of intravenous magnesium sulfate in the maintenance phase 1g / h versus 2 g / h to~     prevent eclampsia in pregnant and postpartum women with severe preeclampsia (pure or~     superimposed).~   "
89470|NCT02396017|"~     To compare the small bowel cleanliness for wireless capsule endoscopy using two different~     Polyethylene Glycol administration schedules (before the wireless capsule endoscopy ingestion~     versus in a split-dose fashion).~   "
89471|NCT02396004|"~     Aim of study:~      To conduct an observational study to collect cerebral and renal perfusion data through NIRS~     before and after treatment of PDA by medication or by PDA ligation. The data post treatment~     would form the basis for normative baseline data in VLBW preterm newborn babies, particularly~     in the Asian population.~      Study population/inclusion criteria:~      VLBW newborn babies with hemodynamically significant PDA by echocardiography.~      Exclusion criteria:~      Major malformations Moribund patients~   "
89472|NCT02395991|"~     The purpose of this study is to observe transient dyspnea pattern after Gd-EOB-DTPA~     administration by obtaining continuous dynamic T1 weighted image data.~   "
89473|NCT02395978|"~     The purpose of this study is to evaluate the safety and efficacy in patients with major~     depressive disorder.~   "
89474|NCT02395965|"~     The SPECIFIC AIM of this research study is to evaluate the utilization, effectiveness, and~     safety of osteopathic manipulative treatment (OMT) using data collected from patients~     receiving OMT in the clinical setting within the established practice-based research network~     DO-Touch.NET.~      . The HYPOTHESES of this research study are the following:~        -  OMT is primarily used in the treatment of musculoskeletal pain disorders.~        -  Patients receiving OMT will have decreased symptoms and improved quality-of-life.~        -  The most common side effect reported by patients receiving OMT will be muscle soreness.~   "
89512|NCT02395471|"~     This study will assess the Minimally Invasive Esophageal Cytology Collection System in~     Patients with Barrett's Esophagus or GERD Symptoms.~   "
89477|NCT02395926|"~     Choline alfoscerate(L-alfa glycerylphosphorylcholine) is a natural compound found in the~     brain and breast. Choline alfoscerate contains 40.8% of choline and has a produrig structure~     and separated by a precursor of choline and nerve cell membrane precursor of acetylcholine~     glycerophosphate. Choline alfoscerate Colin normalization of nerve pathways, nerve cell~     membrane play and acetylcholine receptor function secondary symptoms caused by~     cerebrovascular deficiency and indirectly through activation of metabolism, has a~     degenerative effect on the brain organic mental syndrome.~      Currently marketed oral choline alfoscerate received a geriatric cognitive impairment,~     secondary symptoms and degeneration, or soft capsule is authorized to prescription drugs for~     degenerative brain organic mental syndrome caused by cerebrovascular deficiency. Gliatilin~     soft capsules containing 400 mg per 1 capsule 2-3 times one days're supposed to take when~     considering optimal convenience and efficiency of the drug in patients with the development~     of sustained release formulations that can be maintained for a long period of time, a certain~     concentration is required. Accordingly, the modern drug by reducing the frequency of~     administration a day circuit is to develop a sustained release formulation of choline~     alfoscerate HT-003 600 mg medication compliance for the purpose of raising. 2 tablets at a~     time (600 mg x 2) can be taken one day to 1200 mg is required by taking.~      Therefore, for the development of sustained release formulation, the test in healthy adult~     male volunteers targets choline alfoscerate soft capsule formulation of 400mg 3 times per 1~     day and sustained-release tablet 600mg 2time per 1 day, pharmacokinetic properties and safety~     of a single dose should be evaluated when compared.~   "
89478|NCT02395913|"~     Acebrophylline is metabolized by being separated into Ambroxol and 7-theophylline when orally~     administered as a salt composed of an acid-base as a compound that was synthesized by and~     chloride (salifying) the ambroxol to 7-theophylline. Acebrophylline is selectively applied to~     the bronchial or lung tissue and inhibit the activity of phospholipase bronchoalveolar shows~     the expectorant action to raise the surface activity of the alveolar, leukotrienes (LTs) and~     by suppressing the production of prostaglandins (PGs), showed potent anti-inflammatory~     activity, bronchial was celebrated by reducing the bronchial hyperreactivity to normal state~     is allowed to recuperate or extended.~      It was developed to improve compliance improve pharmaceutically Surfolase~     capsule(Acebrophylline 100mg) that intake twice daily 100mg to Surfolase CR(Acebrophylline~     200mg) that intake once daily 200mg~   "
89479|NCT02395900|"~     To study the effects of Flaxseed supplement on lipid profile, liver enzymes, inflammatory~     factors and hepatic fibrosis in patients with Nonalcoholic Steatohepatitis (NASH), 50~     patients who referred to Gastrointestinal (GI) clinic with steatosis grade 2 and 3 will be~     randomly allocated to receive placebos or 30 grams Flaxseed powder for 12 weeks; both groups~     will be advised to adherence the investigators' diet and exercise program too. At the first~     and the end of the intervention, lipid profiles, liver enzymes, some inflammatory markers,~     and liver fibrosis will be assessed and compared between groups.~   "
89480|NCT02395887|"~     High percentage of chronic back pain is due to spinal stenosis. The clinical picture is of~     'neurogenic claudication' which effects postural balance and stability. If conservative~     treatment fail to improve symptoms, an invasive treatment which includes spinal decompression~     can be done.~      The research is an observational prospective one, pre and post operational intervention. The~     aim is to examine whether an operational intervention improves quality of life, pain,~     postural balance an stability among patients.~      It's important to clarify, that although there is operational intervention, the research is~     observational. The decision weather to operate or not, is not a part of the research. The~     investigators assume that since there is a population that independently going through an~     operation, the investigators can observe this population and evaluate different aspects of~     the operation outcomes.~   "
89481|NCT02395874|"~     To study the effect of combined tDCS plus speech therapy compared to sham-tDCS plus speech~     therapy in subacute stroke patients suffering from moderate or severe aphasia. The patients~     will be randomized by a computer-generated lot. Assessment will be performed at study onset,~     after six weeks at the end of the specific intervention and 4 months after stroke onset for~     follow-up.~   "
89482|NCT02395861|"~     Severe diseases in intensive care unit (ICU) patients are associated with a high mortality~     rate which nevertheless remains difficult to predict. Recently, the abolition of some~     brainstem reflexes at clinical examination of ICU patients within the first 24 hours after~     has been shown of prognostic value in ICU patients requiring sedation. Early abolition of the~     cough reflex was associated with an increase in mortality and that of the oculocephalic~     reflex was predictive of coma or delirium after sedation has been stopped. A dysfunction of~     the brainstem may account for these results and be present in other patient subpopulations,~     particularly those who do not receive iv sedation or the brain injured patients, who were~     eluded from the previous study. This dysfunction could take place in the muti-organ failure~     characteristic of the severe ICU patient. On the other hand, a preliminary study performed on~     somatosensory evoked potentials has shown that a latency of the P14 wave greater than 16 ms~     between day 1 and day 3 after admission was associated with death at 28 days. The primary~     goal of this project is to confirm this hypothesis. By studying the clinical and~     electrophysiological responses of the brainstem in ICU patients, with or without brain~     injury, with alteration of consciousness in relation or not with sedation. The other~     objectives are to determine the correlations between neurophysiological clinical~     neurological, or neuroradiological data with delirium occurrence.~      The main objective of this study is to determine, in ICU patients with or without brain~     injury and with alteration of consciousness in relation or not with sedation, if abolition of~     the cough reflex at Day 1 after admission is predictive of mortality at 28 days, independent~     from cause for admission and severity.~   "
89483|NCT02395848|"~     This is a medical research study designed to look at the safety and efficacy of 30-day course~     of fidaxomicin for treatment of recurrent CDI (Clostridium difficile Infection). CDI is an~     infection that results when the normal flora (resident bacteria) of the colon is~     substantially altered by antibiotic treatment. The decrease in this normal flora allows for~     the growth of the C. difficile bacteria. Fidaxomicin is an antibiotic which is approved by~     Health Canada for treatment of CDI. Only patients with a primary case of CDI or 1st episode~     of recurrent CDI have been studied using a 10-day course of fidaxomicin.~   "
89484|NCT02395835|"~     The main objective of this study was to assess whether clinical, anthropometric, and~     biochemical variables of the mother were associated with changes in the methylation of the~     PPARg promoter region (-351 to -260). Methodology: This was a matched cohort study with two~     groups: a) normal weight (NW) pregnant women (n = 21) and their offspring, and b) overweight~     (OW) pregnant women (n = 20) and their offspring. DNA was extracted from leukocytes~     (4000-10,000 cells) in the MagnaPure (Roche) using the MagNAPure LC DNA Isolation Kit 1~     (Roche, Germany). The treatment of DNA (2 µg) was performed with sodium bisulfite (EZ DNA~     Methylation-Direct Kit, ZymoResearch). Real-time polymerase chain reaction (qPCR) was~     performed in a LightCycler 2.0 (Roche) using the SYBR® Advantage® qPCR Premix Kit (Clontech).~   "
89485|NCT02395822|"~     A phase II trial of CD3/CD19 depleted, IL-15 activated, donor natural killer (NK) cells in~     adults and subcutaneous IL-15 given after a preparative regimen for the treatment of relapsed~     or refractory acute myelogenous leukemia (AML). The primary objective is to study the~     potential efficacy of NK cells and IL-15 to achieve complete remission while maintaining~     safety.~   "
89486|NCT02395809|"~     Lateral internal sphinterotomy (LIS) is the gold standard against which all treatments are~     compared with a healing rate over 92%. However, the most serious complication of this~     procedure is anal incontinence. To overcome these problems, continued efforts are being tried~     to find less invasive treatments modalities for anal fissure that is as effective as surgical~     therapy with lower morbidity.~   "
89487|NCT02395796|"~     Epidural analgesia is highly effective for labor pain relief and is widely chosen by pregnant~     patients. However, placement of the epidural needle can be challenging in pregnant patients~     due to lax tissue ligaments and edema so that the traditional loss of resistance method (LOR)~     used to find the space may be subtle leading to retries which may delay onset of analgesia as~     well as increase the risk of complications. The ability to transduce a pulsatile pressure~     waveform from epidural needles placed in non-laboring patients correlates highly with~     successful placement of the epidural needle. We wish to evaluate the efficacy of obtaining a~     pulsatile pressure waveform with correct epidural needle placement in laboring women.~   "
89488|NCT02395783|"~     Neurocognitive sequelae observed in preterm represent a major health problem for which there~     is no preventive treatment approved to date. These effects are the result of a multifactorial~     brain damage occurring in developing prenatal and perinatal period. Melatonin, the principal~     hormone secreted by the pineal gland has neuroprotective properties in various experimental~     animal models of perinatal brain damage level. This hormone readily crosses the placental~     barrier, its antenatal administration would have a neuroprotective effect in the case of~     preventive preterm birth before 28 weeks of amenorrhea.~      The objective of this study determine the dose of melatonin administered parenterally in~     prenatal maternal in preterm labor to reduce brain damage in the white matter detected by~     diffusion tensor imaging (DTI) with statistical spatial analysis (TBSS) to the theoretical~     term of 40 weeks in children born prematurely.~   "
89489|NCT02395770|"~     Objectives: Evaluate the effects of a rehabilitation program based on movement training on~     symptoms, functional limitations and acromiohumeral distance (AHD) in individuals with SPS.~      Methods: Twenty-five participants with SPS participated in a 6-week program. Outcomes of both~     groups were evaluated at baseline and 6 weeks. Changes in symptoms and functional limitations~     were assessed. Changes in AHD for both groups were assessed using ultrasonographic measures.~   "
89490|NCT02395757|"~     Age-related macular degeneration (AMD) is an acquired retinal pathology affecting the central~     region of the retina responsible for discrimination between high spatial frequencies~     (reading), colour vision and the central visual field. The loss of visual acuity which occurs~     with the onset of AMD significantly affects patients' quality of life. In developed~     countries, AMD is the leading cause of vision impairment for people aged over 50 years. Its~     prevalence in Europe in people aged over 65 years is 3.3%. In France, around 2 million people~     suffer from this disease.~      In the first stage of the disease it is known as age-related maculopathy (ARM). This early~     form of the disease can develop into intermediate AMD (stage 3 of the AREDS classification)~     and then advanced AMD (stage 4 AREDS), which can be atrophic or exudative. In cases of~     exudative AMD, the intravitreal administration of anti-VEGF drugs can limit the disease's~     progression.~      It is therefore vital to adopt a strategy to assess the stage of the disease and provide the~     appropriate care management at the earliest possible stage. This is even more important for~     patients with advanced AMD in one eye and intermediate AMD in the fellow eye, as the risk of~     the fellow eye progressing to the advanced stage within 5 years is between 35% and 53%.~      Microperimetry is a promising new diagnostic method which combines measurements of light~     sensitivity, loss of fixation and the anatomy of the retina. It offers a new approach to the~     functional assessment of retinal damage in patients with AMD, as it precisely correlates~     anatomical and functional modifications by measuring the loss of sensitivity and macular~     fixation. It has been shown that the more advanced the patient's AMD is, the further the~     parameters measured by microperimetry are from the norm.~      The investigators want to assess the MAIA™ as a means of screening for AMD progression in~     patients with a high risk of progressing to a more advanced stage (patients presenting one~     eye with advanced AMD and a fellow eye with stage 3 AMD according to the AREDS~     classification). The research hypothesis for our proposed study is that the parameters~     measured using microperimetry will already show abnormal results in the study eye prior to~     progressing to a more advanced stage of the disease. The use of these microperimetric~     parameters as predictor of progression would therefore make it possible to screen eyes likely~     to develop from intermediate to advanced AMD at an earlier stage, and subsequently provide~     patients who need it with earlier follow-up, preventive treatment or adapted, personalized~     rehabilitation as appropriate.~   "
89491|NCT02395744|"~     The purpose of the COPPER - B study is to assess the feasibility, safety, and initial~     efficacy of paclitaxel administration using the OPC for the prevention of restenosis in~     infrapopliteal de novo and restenotic lesions and occlusions using a novel catheter, the OPC.~   "
89492|NCT02395731|"~     This Center for Medicare and Medicaid funded health care innovation award will implement the~     MIND at Home dementia care coordination program (called MIND at Home-Plus) through two~     community-based service agencies (Jewish Community Services, Johns Hopkins Home Care Group)~     to rapidly improve the ability of 600 dually eligible older adults with dementia in the~     Baltimore region to remain at home while improving care quality, enhancing quality of life,~     and reducing total health care costs. MIND at Home participants receive an in-home needs~     assessment followed by up to 18 months of care coordination aimed at filling unmet needs.~   "
89493|NCT02395718|"~     To evaluate differences in health outcomes among elderly patients (age ≥ 75 years) treated in~     a Quick Diagnostic Unit (QDU) compared to the Department of Internal Medicine (DIM). A QDU is~     a medical Short Stay Unit (SSU).~   "
89494|NCT02395705|"~     The effect of neo-adjuvant chemotherapy on survival of patients with thoracic esophageal~     squamous cell carcinomas remains the most controversial part of neo-adjuvant therapy for~     esophageal carcinomas. One of our objectives is to evaluate whether the neo-adjuvant therapy~     with cisplatin and paclitaxel followed by right thoracic approach esophagectomy with total~     2-field lymph node dissection improves the overall survival of thoracic esophageal cancer~     patients.~   "
89497|NCT02395666|"~     The purpose of this research study is to evaluate a new investigational drug to prevent~     reoccurrence of neuroblastoma that is in remission. This study drug is called DFMO. The~     objectives of this study will be to monitor for safety and look at efficacy of DFMO.~      The safety of the proposed dosing regimen in this trial will be tested by an on-going~     risk/benefit assessment during the study. A patient benefiting from treatment, not~     progressing on therapy, and in the absence of any safety issues associated with DFMO may~     continue on treatment up to 27 cycles with the expectation that there will be an overall~     clinical benefit.~      The procedures involved in this study include Medical history, Physical exam, Vital signs~     (blood pressure, pulse, temperature), Blood tests, Urine tests, MRI or CT scan of the~     tumor(s), meta-iodobenzylguanidine (MIBG) scans, and Bone marrow aspirations. All of these~     tests and procedures are considered standard of care for this population. Drug administration~     is also part of this protocol, including an investigational new drug called DFMO.~      The proposed dosing regimen is an oral dose of DFMO tablets two times a day for each day~     while on study. There will be 27 cycles. Each cycle will be 28 days in length.~   "
89498|NCT02395653|"~     The objective of this study is to evaluate the safety and clinical utility of the active,~     SSEC fentanyl 40 micrograms (mcg) for the management of acute, postoperative pain in~     pediatric participants.~   "
89499|NCT02395640|"~     This study is designed to compare the efficacy and safety of XELOX regimen with EOX regimen~     in the first-line treatment of advanced gastric cancer patients.~   "
89500|NCT02395627|"~     The investigators propose a randomized two arm trial, using Simon's 2-stage design, in ER+~     patients with therapy resistant breast cancer to test the optimal sequence and dosing of~     epigenetic immune priming in hormone therapy resistance breast cancer. A third arm (Arm C)~     will include ER-negative patients who will follow the concurrent priming, but exclude~     tamoxifen. The two arms all include vorinostat, TAM and pembrolizumab to evaluate~        -  Sequential priming - begin pembrolizumab in Cycle 1 (Arm B and Arm C) and,~        -  Concurrent priming with maximal dosing of both epigenetic and immune modulators- begin~          pembrolizumab on day 1 in Cycle 2 (Arm A)~   "
89501|NCT02395614|"~     The investigators intend to perform a prospective randomized study and compare the incidence~     of surgical wound infection between mastectomy wounds irrigated with triple antibiotic~     solution (one side) and 0.05% CHG (opposite side) in patients undergoing bilateral breast~     reconstruction. Each patient will receive triple antibiotic solution on one breast and the~     CHG on the other breast.~   "
89502|NCT02395601|"~     First in human, open-label, sequential dose escalation and expansion study of CPI-1205 in~     patients with progressive B-cell lymphomas. CPI-1205 is a small molecule inhibitor of EZH2.~   "
89503|NCT02395588|"~     This study will test if standardized care helps patients feel better, if it can be~     implemented in rural hospitals, and find out which healthcare processes and outcomes are most~     important to heart failure patients.~   "
89504|NCT02395575|"~     The primary objective of this study is to evaluate the impact of the result of the Prosigna~     Test (assay) on the therapeutic decision of adjuvant therapy (chemotherapy and hormone~     therapy) in patients suffering from early-stage breast cancer.~   "
89505|NCT02395562|"~     Several studies show that the incidence of skin cancer parallels the length and depth of~     immunosuppression. This study will analyze the correlation of viral reactivation and skin~     cancer in organ transplant recipients.~   "
89506|NCT02395549|"~     This study is designed to investigate the efficacy, safety and tolerability of MTC896 Gel in~     subjects with acne. In this study, MTC896 Gel will be applied at 3 concentrations, twice~     daily (bid) for 12 weeks and compared against a vehicle control.~   "
89507|NCT02395536|"~     The primary purpose of the RIO 2 study is to demonstrate that when the Reveal LINQ™~     insertable cardiac monitoring (ICM) system that records subcutaneous ECG insertion procedure~     performed in the in-office setting is as safe as LINQ™ insertions performed in the~     traditional hospital setting (operating room, cardiac catheterization or electrophysiology~     (EP) laboratory).~   "
89508|NCT02395523|"~     This phase II study is to evaluate the effectiveness of hypofractionated proton beam therapy~     (PBT) for Hepatocellular Carcinoma patients in hepatitis B endemic area.~   "
89509|NCT02395510|"~     The primary aim of this study is to evaluate the efficacy of Vortioxetine in an adult~     population with a diagnosis of PD. PD is generally treated with benzodiazepines which are~     very effective but have a high risk for addiction, fall, and cognitive impairment. There is~     still a need for better treatment for PD for longer term use. There are other drugs within~     the SSRI/SNRI class which have proven to be effective in treating patients with this~     diagnosis.~   "
89510|NCT02395497|"~     Injuries to the external genitalia are of great concern to the military with emphasis being~     placed on the surgical reconstruction and psychological health of these Wounded Warriors.~     However, despite significant surgical advances in microvascular surgery and autologous free~     tissue transfer, conventional reconstructions cannot truly replace the complicated structures~     and functions of the penis including the urethra, erogenous sensation, and erectile corporal~     bodies. Conventional reconstruction poses several challenges: patients may not have~     sufficient donor tissue (i.e., the forearm or thigh) due to other injuries or previous~     surgery; multiple operations are often needed to restore the neophallus; the final~     reconstruction only approximates the penis' native form; recreating the urethra is~     challenging and the new urethra is prone to stricture and fistula formation; the erectile~     function necessary for sexual intercourse is often lacking; and insufficient protective~     sensation can lead to penile implant extrusion, infection, and subsequent explantation or~     loss of the reconstruction.~      For these reasons, the investigators propose the current clinical trial to determine~     functional outcomes and quality of life (QOL) for Wounded Warriors and civilians who choose~     to undergo penile allotransplantation. The investigators will combine extensive experience~     performing total penile reconstruction in a large population affected by congenital,~     traumatic, and therapeutically extirpated Genitourinary (GU) deformities and expertise in~     reconstructive transplantation using an immunomodulatory protocol to implement this study.~     The investigators anticipate that penile transplantation can potentially replace like with~     like, restoring the appearance, anatomy, and function of the recipient in a manner far~     superior to autologous reconstruction. This project will establish the ability to perform~     penile allotransplantation using an immunomodulatory protocol and will compare outcomes with~     conventional phalloplasty patient results.~      Study Design: This is a non-randomized subject self-controlled clinical trial to implement a~     cell-based immunomodulatory protocol for penile allotransplantation. An intermediate~     deliverable is achieving allograft survival and functional return with reduced~     dosing/frequency of maintenance immunosuppression on steroid-free monotherapy (tacrolimus)~     immunosuppression. The long-term deliverable and goal is to demonstrate equivalent or~     superior outcomes when compared to satisfaction and QOL in conventional phalloplasty patients~     12-60 months post-transplant.~   "
89511|NCT02395484|"~     Constipation is a heterogeneous and multifactorial disease, influenced by a number of~     different genetic and environmental factors. By applying the standard two-stage GWAS strategy~     to design and carry out a metagenome-wide association study (MGWAS) to find the relationship~     between gut microbiota and constipation, to identify disease-associated metagenomic markers.~   "
89514|NCT02395445|"~     Endotracheal intubation is usually required to allow unrestricted surgical approach. The~     Macintosh laryngoscope is the standard method. However in certain situations as difficult~     airway this technique is ineffective and poorly tolerated by the patient. Fiberoptic~     intubation is the gold standard in this scenario, however sometimes it is not possible due to~     failure or unavailability, so alternatives are needed. The TotalTrack (MedComflow SA,~     Barcelona, Spain) has been designed specifically for the airway management. However, despite~     its use in clinical practice, there are no comparative studies regarding direct laryngoscopy~   "
89515|NCT02395432|"~     Endotracheal intubation is usually required to allow unrestricted surgical approach. The~     Macintosh laryngoscope is the standard method. However in certain situations as difficult~     airway this technique is ineffective and poorly tolerated by the patient. Fiberoptic~     intubation is the gold standard in this scenario, however sometimes it is not possible due to~     failure or unavailability, so alternatives are needed. The TotalTrack (MedComflow SA,~     Barcelona, Spain) has been designed specifically for the airway management. However, despite~     its use in clinical practice, there are no comparative studies regarding direct laryngoscopy.~   "
89516|NCT02395419|"~     Endotracheal intubation is usually required to allow unrestricted surgical approach. The~     Macintosh laryngoscope is the standard method. However in certain situations as difficult~     airway this technique is ineffective and poorly tolerated by the patient. Fiberoptic~     intubation is the gold standard in this scenario, however sometimes it is not possible due to~     failure or unavailability, so alternatives are needed. The TotalTrack (MedComflow SA,~     Barcelona, Spain) and the Airtraq (Prodol Meditec, Vizcaya, España) been designed~     specifically for the airway management. However, despite their use in clinical practice,~     there are no comparative studies.~   "
89517|NCT02395406|"~     Endotracheal intubation is usually required to allow unrestricted surgical approach. The~     Macintosh laryngoscope is the standard method. However in certain situations as difficult~     airway this technique is ineffective and poorly tolerated by the patient. Fiberoptic~     intubation is the gold standard in this scenario, however sometimes it is not possible due to~     failure or unavailability, so alternatives are needed. The TotalTrack (MedComflow SA,~     Barcelona, Spain) and the Airtraq (Prodol Meditec, Vizcaya, España) been designed~     specifically for the airway management. However, despite their use in clinical practice,~     there are no comparative studies.~   "
89518|NCT02395393|"~     Bronchoscopy-guided tissue sampling is a central technique in many diseases including~     diagnosing and staging lung cancers, diagnosing interstitial lung diseases, and acute and/or~     chronic rejections following lung transplantation. Confocal fluorescence microscopy is a~     novel technique used for real-time microscopic imaging of proximal and distal airways,~     microvessels, and inflammatory cells. We hypothesize that confocal fluorescence microscopy~     images of airways and alveolar structures during standard bronchoscopy could help recognize~     and classify the presence or absence of acute or chronic rejection in lung transplant~     recipients.~   "
89519|NCT02395380|"~     Colic and rectal resection represents a majority of hospitalizations in visceral surgery. The~     objective of this study was to evaluate the prognostic of inflammatory markers dosage (CRP,~     procalcitonin and venous lactate) on the postoperative recovery after colorectal surgery and~     on the length of stay.~   "
89520|NCT02395367|"~     The aim of the study is to construct a register system of oral and maxillofacial malignant~     tumors based on a prospective, observational, real-world study in north Chinese population.~   "
89521|NCT02395354|"~     This study will be a multicentre randomized controlled trial to assess the efficacy between~     balloon dilatation and self-expanding metallic stent placement for endoscopic treatment of~     stenosis in Crohn´s Disease.~   "
89522|NCT02395341|"~     Postmenarchal female cancer patients scheduled to undergo cancer therapy may enroll in this~     study to assess changes in existing and novel surrogate measures of fertility potential~     before, during and after chemotherapy. Measures of fertility potential to be tested include~     ultrasound imaging for antral follicle counts and ovarian volumes, endocrine evaluation, and~     assessment of oxidative stress.~   "
89523|NCT02395328|"~     This study consists of a one-year randomized controlled trial investigating the impact of~     mobilized care workers trained and supported by Futures Families, a South African non-profit~     organization, that provide biweekly home visits to families with orphans and vulnerable~     children (OVC) in Tshwane (aka Pretoria) townships, South Africa. Future Families takes a~     family-based approach to addressing the needs of OVC by providing caregivers with~     information, psychosocial support, and access to external services. Caregivers will~     participate in a survey providing information on their personal wellbeing as well as key~     indicators reflecting the wellbeing of each child under their care. Newly enrolled caregivers~     will be randomly assigned to either program participation beginning in late 2014 or to~     delayed participation following the impact survey about one year later. The data will be used~     to test for changes in a set of key program indicators pertaining to child protection, HIV~     prevention, psychosocial wellbeing, education and early childhood development. This study~     aims to strengthen the evidence base for effective family centered programming to address the~     needs of HIV-affected children and their caregivers.~   "
89524|NCT02395315|"~     Type 2 Diabetes Mellitus (DM) is a very prevalent metabolic disorder in the adult population~     affecting roughly 17.7 million people in the US alone. The harmful effect of DM on implant~     integration and survival has been attributed to vascular complications in the alveolar bone~     that lead to compromised blood supply and decreased bone density. Nonetheless, the specific~     detrimental effects of DM in the alveolar bone have not been investigated in humans.~      People with DM generally lose more teeth than persons without diabetes, but implant placement~     in not well controlled diabetics is not routinely performed due to the lack of relevant~     evidence and the risk for implant failure and associated complications. Chemically modified,~     micro-rough, hydrophilic (SLActive®) titanium implant surfaces have been shown to accelerate~     osseointegration of dental implants placed in diabetic animals. It has been hypothesized that~     this enhanced biologic response is due to the biocompatibility and hydrophilicity of the~     surface that actively attracts blood and is populated by progenitor cells, and growth factors~     that improve stromal cell differentiation.~      Hypotheses:~      It is hypothesized that hyperglycemia results in compromised vascularity in the mandible.~     Thus, hydrophilic TiZr implant surfaces (Roxolid®) that actively attract fluids and possess~     excellent osteoconductive properties, may enhance peri-implant bone response in diabetic~     patients to levels comparable to well-controlled diabetics.~   "
89527|NCT02395276|"~     Cardiac pathology is a major risk for brain injury and neurodevelopmental deficit. The most~     common cause of cardiac pathology is congenital heart defects (CHD) about 4-8/1000 live~     births a year. The most common etiology of the brain insult is hypoxic ischemic injury (HII)~     as result of hemodynamic instability in the perioperative period. Similar insults in adults~     with cardiac arrest or infants with neonatal asphyxia, was successfully treated with~     hypothermia, initiated within 6 hours after the event. Although, hypothermia is most likely~     an effective treatment for HII in children with cardiac anomaly, it also carries a risk for~     bleeding or infection of the surgical wound. In this randomized control trial, hypothermia~     treatment will be compared to normothermia treatment of patients in the pediatric cardiac~     intensive care unit (PCICU) following severe HII in the PCICU or operating room. The effect~     will be quantified by MRI, serum biomarkers of brain injury, amplitude integrated EEG,~     neurological evaluation coagulation and infection evaluation in the acute phase and by~     developmental assessment at 1, 6 months and 2, 5 years. Favorable effect of hypothermia with~     minimal risks may open the door for the implementation of hypothermia as a standard care in~     PCICUs.~   "
89528|NCT02395263|"~     The purpose of this study is to determine whether Yuxintine Capsule in different doses are~     effective in the treatment of Depression.~      And to explore the preliminary information of safety and efficacy of Yuxintine Capsule in the~     Chinese Patients with Depression.~   "
89529|NCT02395250|"~     The purpose of this study is to determine whether autologous T cells bearing chimeric antigen~     receptor that can specifically recognize glypican-3 (GPC3) is safe and effective for patients~     with relapsed or refractory hepatocellular carcinoma (HCC).~   "
89530|NCT02395237|"~     The purpose of this study is to assess, after single oral administration under fed~     conditions, the bioequivalence between the two batches of the same glimepiride/metformin~     hydrochloride (HCl) 2 mg/1000 mg fixed dose combination (FDC) tablets (immediate release~     combination tablet Amaryl® M IR 2/1000) manufactured in India and in Turkey.~   "
89531|NCT02395224|"~     The main objective is to provide original research results that may change clinical practice~     related to metastatic colorectal cancer. The study will evaluate treatment and patient care~     at different stages of the disease trajectory and the use of health care for this large group~     of patients. It will be possible to compare the effectiveness of chemotherapy, radiotherapy~     and symptomatic treatment given to real life patients with the efficacy reported in~     randomised clinical trials. By using longitudinal information on imaging, biomarkers,~     clinical staging and place of care it will be possible to improve patient classification at~     various stages of the disease. Based on this, a more appropriate, individualized treatment~     for colorectal cancer may be recommended during the phases of the disease trajectory.~     Participation in this project will not influence the treatment for colorectal cancer. All~     patients will be treated and followed-up according to current regional and national~     guidelines.~   "
89532|NCT02395211|"~     The aim of this study is to evaluate feasibility of a proprioceptive stimulation under visual~     feedback treatment protocol (using Gloreha® device) compared to usual physiotherapy treatment~     in sub-acute stroke patient with Complex regional pain syndrome.~   "
89533|NCT02395198|"~     The aim of the present study is to estimate the national annual prevalence and incidence of~     current hepatitis C virus (HCV) infections among opioid dependent individuals in opioid~     substitution treatment (OST) based on a representative sample of approximately 2,500~     outpatients in 100 substitution facilities across Germany. Furthermore, the study aims to~     describe factors influencing HCV therapy initiation and seroconversion during OST.~   "
89534|NCT02395185|"~     While it has been shown that sucrose or milk ingestion decreases pain responses in heel~     sticks, no study up to this point has determined the best intervention for decreasing the~     pain response during casting for clubfoot deformity.~      The goal of this study is to investigate the effect of three different non-pharmacologic~     interventions (sucrose, milk, water) on pain response during clubfoot casting.~      This study will allow us to discern the best non-pharmacologic intervention for pain control~     during clubfoot casting and to provide a more pleasant, comfortable experience for patients~     and families.~   "
89535|NCT02395172|"~     To demonstrate superiority with regard to overall survival of avelumab versus docetaxel in~     subjects with programmed death ligand 1 (PD-L1) positive, non-small cell lung cancer (NSCLC)~     after failure of a platinum-based doublet.~   "
89536|NCT02395159|"~     Comparison of the Prevena™ IMS with the standard wound management method of sterile plaster~     in vascular surgery patients.~   "
89537|NCT02395146|"~     Thyroid surgeons place an enormous amount of importance and rightly so to the preservation of~     the recurrent laryngeal nerve (RLN) during thyroidectomies. A good knowledge of the anatomy~     of the nerve and meticulous dissection technique and intraoperative identification of the~     nerve are crucial to the anatomic and functional integrity of the nerve. The use of~     intraoperative neural monitoring to aid the surgeon in the identification of the RLN has~     gained acceptance and is considered standard practice in several units. However, lesser~     emphasis has been placed historically on the identification and preservation of the external~     branch of the superior laryngeal nerve (EBSLN) during thyroid surgery. The EBSLN supplies the~     cricothyroid muscle that controls pitch variation during phonation. Unlike damage to the~     recurrent laryngeal nerve which manifests readily as vocal cord paralysis, intraoperative~     damage to EBSLN is difficult to assess postoperatively as visual assessment of the larynx is~     not indicative of the integrity of the nerve. Injury of the EBSLN can cause weakness or~     complete paralysis of the ipsilateral cricothyroid muscle. Patients may report a deeper voice~     or an inability to produce high pitched sounds.~      Patients may also complain of weakness, tightness of the voice, and require extra effort to~     speak. Of note, voice changes with EBSLN injury are subtle in the general population but can~     be devastating in patients who depend on their voice for a living. Importantly, EBSLN injury~     is reported in upto 50% of thyroid surgery in contrast to 12% of recurrent laryngeal nerve~     injury during thyroid surgery. The new guidelines published in the Laryngoscope recommend~     routine intraoperative neural monitoring of EBSLN. The Investigators have a functional system~     in use currently for monitoring recurrent laryngeal nerve intraoperatively and propose to~     study the impact of monitoring the EBSLN using the same neural monitoring device to improve~     voice results following thyroid surgery.~   "
89538|NCT02395133|"~     The primary objective of the study is to assess the ability of different dupilumab dose~     regimens, administered as monotherapy, to maintain the treatment response achieved after 16~     weeks of initial treatment with dupilumab monotherapy compared to placebo.~   "
89564|NCT02394795|"~     The purpose of this study is to verify the efficacy of mFOLFOX6 + panitumumab combination~     therapy and mFOLFOX6 + bevacizumab combination therapy in first-line treatment of~     chemotherapy-naive patients with KRAS/NRAS wild-type, incurable/unresectable,~     advanced/recurrent colorectal cancer.~   "
89565|NCT02394782|"~     This is a 24-month, observational, prospective, multinational, multicenter study to determine~     the relationship between the relapse (percentage of relapse free subjects) and adherence in~     subjects diagnosed with RRMS treated with Rebif (interferon beta-1a) using the RebiSmart®2.0~     and MSdialog™.~   "
89539|NCT02395120|"~     The study is a multi-site, double blind, parallel arm, community-based randomized controlled~     trial (phase III RCT) to evaluate the effectiveness of new referral approaches to increase~     receipt of dental care among inner-city urban and rural elementary school children who were~     screened at school and have restorative treatment needs. The study has 5 arms: The~     experimental intervention is the use of a theoretically driven CSM referral letter alone, the~     letter plus a Dental Information Guide, a reduced CSM referral letter alone, or a reduced CSM~     referral letter plus a reduced Dental Information Guide. The control strategy is the use of a~     standard referral letter. All participating K-4 grade children will receive a screening at~     the beginning of the school year and at the study end point 7 months later to determine if~     the child received dental care. Due to lower than expected enrollment in both the Ohio and~     Washington sites, a second year of recruitment was added to include Bedford School District~     and East Cleveland School District (only KG and other grades if they did not enroll in the~     first year). The same study procedures, schedule and design was utilized for the second year~     of recruitment.~      The primary aim is to evaluate the effectiveness of experimental (new) versus standard~     referral approach given to parents/caregivers in increasing receipt of dental care among~     their children in grades K-4. The secondary aim is to assess changes in parent/caregiver~     illness representation/perception and behavioral intention between enrollment (beginning of~     school year) and follow-up (end of school year) to understand the underlying mechanisms of~     the new vs. standard referral approach that result in receipt of dental care.~      The hypothesis is that CSM-based interventions will increase receipt of dental care compared~     to the standard referral letter.~   "
89540|NCT02395107|"~     Aortic stenosis results in increased filling pressures of the heart. Size and function of the~     left atrium may be a marker for more advanced heart disease (heart failure) in patients with~     severe aortic stenosis, not presenting any apparent symptoms.~      The goal of this study is to establish the importance and possible implications of left~     atrial dilation in asymptomatic patients with aortic valve stenosis.~   "
89541|NCT02395094|"~     Children can experience high levels of anxiety immediately prior to surgery. In fact, this~     can be the most stressful part of the whole surgical experience for children. Anxiety before~     surgery is associated with problems after surgery; such as short-term increased need for pain~     medication and long-term sleep disturbances or behaviour change. Child Life, a program run in~     some North American children's hospitals has developed ways to reduce children's anxiety~     prior to surgery. These techniques can include role-play or story books amongst others.~      In this study, the investigators aim to look at the benefits of the Child Life techniques on~     anxiety levels of children and their caregivers just prior to receiving anesthesia in the~     operating room. The study will include children between the ages of 3 and 10 years old,~     needing day case surgery lasting less than 2 hours, and having never had surgery before. They~     will be randomly allocated to either not receive any intervention by Child Life or to receive~     Child Life intervention in the period prior to their surgery, when they are waiting in the~     Surgical Day Care Unit. Anxiety levels of the children and their caregivers will be measured~     as they arrive in the hospital and immediately prior to anesthesia, to see if there is a~     lower level of anxiety in the group receiving the Child Life intervention.~   "
89542|NCT02395081|"~     A double-blind randomized, placebo-controlled trial comparing the impact of 600 IU, 2000 IU,~     or 4000 IU of Vitamin D3 on third trimester 25(OH)D levels and change from baseline. The~     Vitamin D will be integrated in a standard prenatal vitamin, which will be taken from 12-16~     weeks' gestation and continue throughout pregnancy. Umbilical cord 25(OH)D levels will also~     be determined. The investigators will generate preliminary data regarding Vitamin D intake~     and hypertensive disorders, blood pressure, and arterial function measured by tonography. The~     investigators will independently test blood pressure and proteinuria to identify preeclampsia~     cases.~   "
89543|NCT02395068|"~     Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in~     the extra cellular domain of the human epidermal growth factor receptor (EGFR), inhibiting~     tyrosine kinase activation. It has been approved to treat squamous cell carcinoma of head and~     neck (SCCHN), glioma and nasopharyngeal carcinoma in different countries. Currently, the~     registered clinical trials of Nimotuzumab combined with chemotherapy in advanced non-small~     cell lung cancer, colorectal cancer, esophageal cancer and glioma have been approved and are~     ongoing all over the investigators' country. The main purpose of this study is to evaluate~     the pharmacokinetic characteristics of Nimotuzumab combined with Irinotecan in patients with~     solid tumors.~   "
89544|NCT02395055|"~     This clinical study is a phase 1 study which carried out to establish the pharmacokinetic~     equivalence and equal safety and tolerability profile of BCD-057 (adalimumab biosimilar~     candidate manufactured by CJSC BIOCAD, Russia) and Humira when used as a single subcutaneous~     injection in healthy volunteers.~   "
89545|NCT02395042|"~     This is a safety and efficacy study of LiRIS® in females with interstitial cystitis with~     Hunner's lesions.~   "
89546|NCT02395029|"~     Prospective, open labeled, non-randomized, study to be conducted at a single center. Ten~     subjects will undergo an injection of Placental Matrix-Derived Mesenchymal Stem Cells~     (PMD-MSCs) into the penis for the treatment of Peyronie's Disease. Follow up visits will be~     conducted at 6 weeks, 3 months, 6 months, and 12 months. Subjects will be eligible for~     re-injection at 3 months and/or 6 months as determined by the clinician based on patient~     reported treatment satisfaction.~   "
89547|NCT02395016|"~     Nimotuzumab is a humanized monoclonal antibody against epidermal growth factor receptor~     (EGFR). Clinical trials are ongoing globally to evaluate Nimotuzumab in different~     indications. Nimotuzumab has been approved to treat squamous cell carcinoma of head and neck~     (SCCHN), glioma and nasopharyngeal carcinoma in different countries.The clinical phase Ⅲ~     trial designed to assess overall survival（OS）of the combination of Nimotuzumab administered~     concurrently with Gemcitabine in patients with RAS wild type of locally advanced or~     metastatic pancreatic cancer~   "
89548|NCT02395003|"~     Insulin Resistance is the best predictor of whether the obese adolescent will develop type 2~     diabetes. The present studies will focus on determining what might cause fat to accumulate in~     the subcutaneous fat regions and lead to local inflammation, causing insulin resistance to~     develop in obese adolescents.~   "
89566|NCT02394769|"~     This research study is investigating the use of aspirin as a potential chemopreventive agent~     to reduce risk of colorectal cancer~   "
89567|NCT02394756|"~     The objective of this study is to assess how various silicone hydrogel lenses perform when~     worn by subjects who are heavy digital device users.~   "
89568|NCT02394743|"~     Vascular inflammation is a key factor in both the pathogenesis and outcome of~     atherosclerosis. Renal insufficiency is close correlation with atherosclerosis and~     cardiovascular mortality.~      18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a promising tool for~     identifying and quantifying vascular inflammation within atherosclerotic plaques.Therefore,~     the purpose of the study is to demonstrate the correlation between eGFR and vascular~     inflammation detected by 18F FDG-PET.~   "
89549|NCT02394990|"~     This study is a randomised controlled trial of a new brief intervention with young (16-29)~     adult male patients who have a facial injury sustained as a result of interpersonal violence~     (fighting or assaults). It will be undertaken at the Maxillofacial outpatient trauma clinic~     at the Southern General Hospital, Glasgow. The major risk factors associated with facial~     injury in Scotland are male gender, young age, interpersonal violence and alcohol. Previous~     research with facial injury patients attending this clinic has shown that an Alcohol Brief~     Intervention (ABI) is effective in helping reduce alcohol consumption, so all patients are~     now offered ABI as standard practice. ABI is delivered by trained nurses from Addiction~     Services. This will not be withdrawn. In addition we wish to offer some patients a Violence~     Brief Intervention (VBI). This will be delivered by the same nurses who deliver the ABI. The~     study is randomised so only those selected at random will receive this extra intervention and~     all others will receive treatment as normal (ABI only). VBI is a short psychological~     intervention which uses Brief Motivational Interviewing (BMI) to encourage reflection of~     involvement in violence and consideration of strategies to avoid future violence. The~     intervention also compares participants' attitudes towards violence to those of their peers.~     The intervention takes about 15 minutes, and patients will be involved for an additional~     30-45 minutes longer than normal when they attend the clinic, including consent and baseline~     data collection. Patients will be followed up by telephone at 1, 3 and 6 months, and asked a~     suite of questions which will take approximately 15 minutes on each occasion. We wish to~     determine whether a VBI of this type has any effect on attitudes to violence or propensity~     for involvement in violence or on reinjury, examined through self report measures and~     routinely collected health and criminal justice data at 12 months post intervention.~   "
89550|NCT02394977|"~     The investigators conducted a randomized, controlled, single-blinded study of patients~     undergoing CPR for cardiac arrest in the mixed medical-surgical ICUs of four academic~     teaching hospitals in Tehran, Iran from June 1 to October 31, 2014. The intervention and~     control groups were labeled group 1 and 2 respectively. The assessment tool was scored by the~     principle investigator and an ICU nurse. The data analyzer was blinded to group randomization~     and was not present during CPR.~   "
89551|NCT02394964|"~     The immune system is influenced by the commensal microbes that live in the gut and on the~     skin. This study aims to characterize the microbiota of subjects with autoimmune disease in~     order to determine whether certain microbial species may cause or worsen immune-mediated~     diseases~   "
89552|NCT02394951|"~     The investigators seek to investigate certain patient characteristics that would predict the~     response to a currently approved analgesic, pregabalin, in patients with chronic pain due to~     nerve damage caused by chemotherapy. Patients with this painful condition, called~     chemotherapy-induced peripheral neuropathy (CIPN) have a current or recent history of~     chemotherapy with particular chemotherapy agents called taxanes or oxaliplatin. The~     investigators will recruit potential subjects from both the Siteman Cancer Center and the~     Washington University Pain Management Center. Those patients who meet the inclusion and~     satisfy the exclusion criteria will be enrolled. Subjects will undergo mechanical and thermal~     sensitivity testing on their extremities, will provide quality of life information by~     completing questionnaires and will receive pregabalin followed by placebo, or placebo~     followed by pregabalin [crossover design] in order to assess how well the sensory tests~     predict the analgesic effect of pregabalin (compared to placebo).~   "
89553|NCT02394938|"~     Aims. To describe a new conceptual framework and to test the effectiveness of a recorded~     music listening protocol on symptom burden and quality of life in heart failure patients.~   "
89554|NCT02394925|"~     The primary objective of this study is to determine the retention rate over a two month~     period of vision correction in emmetropic, presbyopes fitted with multifocal contact lenses.~   "
89555|NCT02394912|"~     The purpose of this study is to evaluate the safety and effectiveness of the LUMIFI with Crux~     VCF System for deployment of the Crux VCF. The study will compare the method of Crux VCF~     deployment using the LUMIFI with Crux VCF System (IVUS guidance) with the historical results~     of the Crux VCF System (fluoroscopic guidance). The study will include enrollment into a roll~     in phase consisting of 2 study subjects per site prior to enrollment into the primary~     treatment phase for primary analyses. The purpose of the roll in phase is to assure~     compliance with site training on the use of the investigational device and protocol workflow.~   "
89556|NCT02394899|"~     There are all significant risk factors for poor early cognitive development and, as such,~     neurocognitive deficits have been demonstrated in pre-school children with sickle cell~     disease (SCD). This project assesses the efficacy of using an evidence-based early~     stimulation program, combined with components to help parents cope with stress, delivered~     during six routine monthly clinic visits to parents of children with sickle cell disease. It~     is hoped that this innovation will improve parental psychological outcomes, as well as child~     developmental outcomes.~   "
89557|NCT02394886|"~     This is a phase I open-label study to evaluate the safety of ALLO-ASC-DFU in diabetic foot~     ulcers patients. ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived~     mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release~     growth factors such as vascular endothelial growth factor (VEGF) and hepatocyte growth factor~     (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide an~     new option in treating a diabetic foot ulcer.~   "
89558|NCT02394873|"~     This is a phase I study to evaluate the safety of ALLO-ASC-DFU for the treatment of deep~     second-degree burn wound patients. ALLO-ASC-DFU is a hydrogel sheet containing allogenic~     adipose-derived mesenchymal stem cells. Adipose-derived stem cells release growth factors~     such as vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), which~     can enhance wound healing and regeneration of new tissue, finally may provide a new option in~     treating a burn.~   "
89559|NCT02394860|"~     The aim of this study is to assess the influence of the severity of chronic periodontitis on~     hemodynamic parameters in hypertensive patients.Secondary purposes of this protocol is to~     identify evolution of several biomarkers and correlate the clinical situation with oral~     microflora.~   "
89560|NCT02394847|"~     Electroconvulsive therapy has been used for many years for different types of physiatric~     diseases. General anesthesia is used during the procedure. Different anesthesiologists use~     different regimens. The duration of seizure is important in this procedure. The investigators~     evaluated the relationship between the dose of propofol and the number of electroconvulsive~     therapy and duration of the seizure.~   "
89561|NCT02394834|"~     The purpose of this study is to investigate biomarkers which may be predictors of efficacy~     and safety of treatment with mFOLFOX6 + bevacizumab versus. mFOLFOX6 + panitumumab therapy in~     patients with chemotherapy-naïve unresectable advanced or recurrent colorectal cancer.~   "
89562|NCT02394821|"~     For odor control malignant wounds (MW), use is 0.8% metronidazole solution - second~     recommendation scientific and clinical practice. But no this formulation available in Brazil~     , and its application to nursing steeps metronidazole tablets , diluted in saline and applied~     to the bed of (MW) . Thus , it is used off label for metronidazole ( tablets orally applied~     via  topical  - but it is not intact skin or mucosa ) , nursing and eventually manipulate~     the solution at bedside , and by law this power is pharmacist bedside and can not be taken .~      Family antiseptic chlorhexidine was developed with the purpose of use in infected wounds~     called polihexanide ( PHMB ) . In Brazil is now available for hospital and home care ( 0.2 %~     Aquasept ® ) use. Evidence reported positive results in controlling infection of chronic~     wounds such as pressure ulcers . Although not tested its efficacy in odor control. Thus the~     study aims to compare metronidazole solution 0.8 % versus 0.2 % PHMB in odor control , where~     , if the results are favorable to PHMB we have a treatment option in odor control with ready~     to use formulation and easy access . Evaluate and compare the effectiveness of metronidazole~     solution 0.8% and polihexanide solution (PHMB) in odor control in MW. Aims: Evaluate and~     compare the time needed for odor control (reduction in days), using metronidazole and PHMB in~     MW (primary endpoint); Evaluate and compare the perceptions of patients, nurses and~     researcher on the odor MW, using metronidazole and PHMB in the MW; Evaluate and compare the~     pain reported by patients during dressing changes, using metronidazole and PHMB in the MW;~     Evaluate and compare the quality of life of patients before and after the use of~     metronidazole and PHMB in MW. This is a randomized, double -blind study with patients~     diagnosed with cancer and patients with MW with odor clinical trial . The sample consisted of~     24 subjects divided into 2 groups (control - metronidazole group and experimental group -~     PHMB ) , recruited in one cancer hospital in the city of São Paulo (AC Camargo Cancer~     Center), which has as protocol description in odor control MW metronidazole . After~     acceptance by the subject and return the Statement of Informed Consent signed , randomization~     will be done .~      For blinding , 0.8 % metronidazole solution will be provided by a compounding pharmacy (after~     stability testing of tablet diluted - and then stipulated expiration date) , and PHMB be~     bought from the supplier , delivered to the same compounding pharmacy which stores the PHMB~     in identical bottles to metronidazole ( only the responsible researcher will know to which~     group the subject was randomized ) .~      The evaluation of the odor will be taken by 3  employees  and the patient through 3 scales~     at zero , four, eight and twelve days ( or earlier if classified as  odorless  by 3~     reviewers and the patient ) . Two scales about painful sensations in exchange for healing ,~     one on quality of life will be applied to the patient and a specifically on the impact of~     odor on the subject's life.~      To meet the proposed objectives, the data will be analyzed by: Friedman test to assess the~     odor reduction with respect to time; Mann-Whitney (or t test) for comparison of groups and~     the Fisher exact test to compare proportions. Data will be presented in the form of frequency~     tables for categorical variables and means, standard deviations and position measurements for~     quantitative variables. Will also be performed non-parametric analysis of ordinal data, or~     parametric analysis with Generalized Estimation Equation for binomial variables, depending on~     the data distribution and the sample size.~   "
89569|NCT02394730|"~     ADVICE is a randomised, international, double-blind, placebo-controlled trial. The purpose of~     the ADVICE study is to compare the safety and efficacy of vorapaxar in reducing d-dimer~     expression and markers of cellular immune activation over a period of 12 weeks among people~     with HIV infection who are successfully treated with combination antiretroviral therapy~     containing an HIV integrase inhibitor. A secondary objective of the study will be to~     demonstrate that following cessation of vorapaxar in patients with well controlled HIV~     replication there will be an increase in the levels of d-dimer over a 6 week period. 60~     participants from 4 clinical sites in Australia and the USA will be recruited and followed~     for a minimum of 18 weeks.~   "
89570|NCT02394717|"~     The investigators long term-goal is to help YMCA programs across the nation successfully~     acheive the Y of USA Healthy Eating and Physical Activity Standards. Our objective here is~     threefold. First, the investigators will work with South Carolina YMCA leadership to achieve~     the Healthy Eating and Physical Activity Standards and implement our HEPA Strategies in~     YMCA programs across the state, evaluate the uptake of and adherence to the standards and~     strategies, and identify factors that influence their implementation. Second, the~     investigators will evaluate the impact of acheiving the standards on children's MVPA and the~     serving and consumption of FV and water during the programs. Third, the investigators will~     evaluate the costs associated with and the cost-effectiveness of meeting the standards in~     terms of improvements in activity and healthy eating.~   "
89571|NCT02394704|"~     Intrusive negative thinking styles such as rumination are typical of many psychiatric~     disorders, are difficult to treat, and predict poor treatment outcome. The investigators~     propose to evaluate a new intervention for negative thinking that capitalizes and builds on~     the preserved ability to attend to physical sensation. The investigators will examine changes~     in physiological mechanisms and symptoms.~   "
89572|NCT02394691|"~     In this study, researchers will show to caregivers of patients how to use a tDCS device (this~     device was designed to be easy to use, with fixed parameters and only one button to press to~     run the stimulation). They will be asked to apply a stimulation every day, 5 days per week~     during for 4 weeks, in chronic patients in minimally conscious state (MCS).~      2 sessions of 4 weeks of stimulations will be realized, one anodal and one sham in a~     randomized order. Before and after each session, behavioral improvement will be assessed with~     the Coma Recovery Scale Revised (CRS-R). A final assessment will be done 8 weeks after the~     end of the sessions to assess the long term effect of tDCS.~   "
89573|NCT02394678|"~     Intraventricular haemorrhage (IVH) - bleeding into the normal fluid spaces (ventricles)~     within the brain - is associated with a high risk of death or significant long-term~     disability. IVH leads to an increase pressure within the head and triggers inflammation and~     swelling in the surrounding brain. The ideal treatment for IVH would both rapidly relieve~     pressure and safely remove as much blood as possible to prevent any further injury to the~     brain. Currently, patients are managed by inserting a tube into the ventricle that drains~     fluid to the outside and helps reduce pressure, but does not address the blood clot itself,~     which naturally dissolves only over several days or weeks.~      Furthermore, these drains frequently block because of blood clots that for within them. If~     that occurs a repeat operation is required to replace them. Experimental treatments include~     infusing drugs to accelerate clot breakdown but this can nonetheless still take a number of~     days and the process introduces a risk of infection and fresh bleeding. Surgery to remove the~     blood clot is hazardous, technically challenging, and generally not very successful.~     Therefore, at the present time, none of the available options achieve all the stated goals of~     IVH treatment and there is an unmet need for better interventions.~      In this study the investigators propose to pilot a novel instrument that employs a high~     pressure but very localised microjet of water to mechanically disrupt blood clots and then~     sucks the debris away. This technique has been highly successful in reopening blocked~     arteries in the heart and, importantly, does so without damaging the underlying vessel~     lining. In the context of IVH, this should allow rapid removal of blood from the ventricles~     while causing minimal trauma to the brain. Clearing the blood early will prevent the build-up~     of pressure and inflammation, and improve the chances of patients making a good recovery.~   "
89574|NCT02394665|"~     In summary, the overall prognosis of glioblastoma (GBM) patients remains poor. Although~     clinical gains have been achieved in the past, these have been modest, with a majority of~     patients succumbing to local disease progression within 2 years. New strategies for treatment~     need to be identified which enhance local control above the current treatment regimen in~     order to achieve further clinical gains in this disease. Favorable early experience with~     magnetic resonance spectroscopy imaging (MRSI) demonstrates that metabolic imaging can~     identify active tumor beyond standard MRI as well as high risk regions at risk for local~     failure. There is also clinical evidence that limited field dose escalation with either~     simultaneous integrated boost (SIB) or stereotactic radiosurgery (SRS) is feasible and safe.~     Coupling these findings provide the rationale for this proposed Phase II trial designed to~     define efficacy and toxicity of the novel treatment approach of whole brain volumetric 3D~     MRSI guided dose-escalated radiation therapy (RT) in newly diagnosed GBM patients.~   "
89575|NCT02394652|"~     Cervical cancer remains an important health problem worldwide. Poor tumor oxygenation~     (hypoxia) is associated with inferior survival in cervical cancer and resistance to radiation~     treatment. Hypoxia-modifying therapies improve survival, but existing therapies are~     impractical and/or toxic. Metformin, a non-toxic drug for diabetes, has been shown to~     decrease tumor hypoxia in animal studies and its use is associated with better survival in~     diabetic cancer patients. It is hypothesized that metformin may decrease cervical tumor~     hypoxia and thereby improve tumor response to radiation and survival in patients with locally~     advanced cervix cancer.~      This is a randomized, multicenter phase II study of standard chemoradiation in combination~     with metformin versus standard chemoradiation alone in women with locally advanced cervix~     cancer. Women randomized to the metformin group will take metformin starting 1 week prior to~     standard chemoradiation and throughout the duration of external radiation treatment. Tumor~     hypoxia will be measured by a special X-ray test called positron emission test (PET)~     performed with a hypoxia dye called FAZA. The main purpose of this study is to see if~     metformin decreases tumor hypoxia measured on FAZA-PET; information about response and side~     effects will also be collected.~   "
89583|NCT02394548|"~     This research study is examining the benefit of a novel radiation planning approach on the~     likelihood of developing severe esophagitis (irritation and inflammation of the esophagus)~     during the course of radiation therapy with concurrent chemotherapy which is associated with~     very painful and difficult swallowing.~   "
89584|NCT02394535|"~     The goal of this clinical research study is to find the highest tolerable dose of Abraxane™~     (nab-paclitaxel) that can be given in combination with capecitabine and radiation therapy to~     patients with pancreatic cancer. The safety of this drug and drug combination will also be~     studied.~   "
89576|NCT02394639|"~     The goal of this project is the development of an EEG-cap (min. 21 electrodes) with~     user-friendly active dry electrodes that meets the expectations of the users regarding~     comfort and esthetics, without losing sight of the functional and technical demands for~     recording high quality EEG signals. The purpose is to use the EEG-cap to investigate clinical~     neurological disorders (e.g. epilepsy). The EEG-cap could also be used at home so that~     hospital admission in the EMU can be avoided for some patients and an increasing number of~     patients can be examined.~      In this stage of the project video-EEG recording with the prototype will be compared to the~     conventional way (cup-electrodes and collodion) of recording in the EMU.~      Minimum 1 - maximum 10 patients with prominent IEDs will be included. After the conventional~     recording is completed, the patient will undergo a recording of maximum 5 hours with the~     prototype.~      There will be an visual and clinical evaluation of the EEG-signals (blinded) and a technical~     evaluation of the EEG-signals. User experience and experience of the EEG-technologists will~     also be collected.~   "
89577|NCT02394626|"~     Patients with glioblastoma face a grim prognosis. Despite recent advancement in neurosurgical~     technology and neuro-oncology glioblastomas almost invariably progress or recur after a~     median of 4-8 months. The strategy to repeat tumor resection at recurrence in order to~     minimize tumor load and thus to facilitate subsequent second-line therapy has been shown to~     be feasible and safe.~      However, evidence for a survival benefit of surgery for recurrent glioblastoma is scarce and~     relies entirely on retrospective analyses. While most retrospective analyses report an~     apparent survival benefit, an EORTC meta-analysis on second-line therapies found no survival~     difference in patients with or without surgery at recurrence. With regard to the risks and~     costs inherent to surgery for glioblastoma, a randomized controlled trial is required.~      The purpose of the study is to compare the effect of craniotomy and tumor resection followed~     by adjuvant second-line therapy to no surgery followed by second-line therapy on overall~     survival, neurological status, and quality of life. Analysis of overall survival will be used~     to improve sample size estimation of a subsequent phase III trial for craniotomy and tumor~     resection of glioblastoma recurrence in cooperation with the EORTC.~   "
89578|NCT02394613|"~     Glaucoma is a major cause of irreversible blindness worldwide, caused by retinal nerve cell~     (RGC) death. This is currently identified only after significant vision loss has already~     occurred with an early event in, and a potential marker of, this process being RGC~     apoptosis (a form of cell death).~      This study aims to investigate the tolerability and safety of ANX776, as part of the new~     Detection of Apoptosing Retinal Cells (DARC) technique. This has been developed by the~     laboratory of DARC IP holder and grant applicant: Prof. M. Francesca Cordeiro. A secondary~     aim is to initially establish the ability of DARC to identify RGC apoptosis in the diagnosis~     of glaucoma in healthy and progressive glaucoma/glaucoma-suspect/ocular hypertensive~     patients. As a positive control for this secondary aim of this study, patients with~     Non-arteritic Anterior Ischaemic Optic Neuropathy (NAION) will be recruited.~      During the study, each patient will undergo several ophthalmological examinations, imaging of~     the back of the eye using established clinical devices, and blood sampling for studying the~     safety and toxicology profile of ANX776.~      The understanding of the safety profile of ANX776 is crucial for the use of DARC in patients,~     and its application as a potentially powerful new clinical tool with which to identify~     patients with early glaucoma before their vision is lost. If successful, it opens the door to~     directly observing effects of glaucoma treatments, including the assessment of new,~     breakthrough therapies.~   "
89579|NCT02394600|"~     This pilot study is a Phase IV, single center, placebo-controlled, parallel study design~     conducted using the Environmental Exposure Unit (EEU). The study will aim to be determine~     whether there are any benefits from Grastek® for the treatment of birch-pollen induced~     allergic rhinoconjunctivitis. Grastek® is a Health Canada and FDA approved sublingual~     immunotherapy (SLIT) for the treatment of grass-pollen induced allergic rhinoconjunctivitis.~     The EEU provides a closed environment in which participants are exposed to a predetermined,~     controlled, constant level of airborne pollen. 96 participants will complete this study and~     will either receive Grastek® or placebo in a 1:1 ratio. The study will consist of a screening~     visit, a pre-treatment pollen exposure visit, 60 days of treatment with Grastek® or placebo,~     two treatment visits and a follow-up pollen exposure visit.~   "
89580|NCT02394587|"~     Significance: The purpose of this exploratory study is to test the feasibility,~     accessibility, and effects of a mindfulness-based stress reduction program (MBSR) on reducing~     pain catastrophizing in persons with sickle cell disease (SCD) and chronic pain. One of the~     most difficult symptoms for SCD patients to manage is chronic pain. Approximately one-third~     of SCD patients experience chronic pain, which is associated with pain catastrophizing. Pain~     catastrophizing is a negative mental state toward pain stimuli and pain experience, and is~     associated with increased pain severity, pain interference, and lower social functioning,~     physical functioning, and mental health. There have been no psychobehavioral intervention~     studies that have attempted to alter the experience of pain catastrophizing in persons with~     SCD. MBSR is a complementary group-based therapy that emphasizes nonjudgmental awareness of~     thoughts, feelings, and bodily sensations. With no pharmacological or non-pharmacological~     treatment for catastrophizing in persons with SCD, MBSR offers a potential solution to this~     highly significant problem for both SCD patients and providers. This project will be the~     first randomized controlled trial (RCT) of MBSR to reduce pain catastrophizing, and improve~     quality of life for SCD patients with chronic pain.~      Methods: This study will enroll 60 adult patients with SCD and chronic pain from the Duke~     Adult Sickle Cell Clinic. Patients will be randomized to a MBSR or wait-listed control group.~     The MBSR group will complete a 6- week, group-based telephonic MBSR program that is~     administered by a certified MBSR clinician once a week for 90 minutes. MBSR feasibility,~     acceptability, and effects on pain catastrophizing will be assessed by questionnaires at~     baseline, week 1, 3, and 6 in both groups. At the end of week 6, 10 randomly selected MBSR~     participants will complete semi-scripted telephone interviews to help assess intervention~     acceptability, and the wait-listed control condition will be offered the same MBSR~     intervention.~   "
89581|NCT02394574|"~     Exposure to Household air pollution (HAP) from burning biomass fuels is responsible for an~     estimated 2.5 million premature deaths and 3.7% of the loss of disability-adjusted life years~     (DALY) every year in developing countries.52-54 Of all environmental risks, such as unsafe~     water, poor sanitation, climate change and lead exposure, HAP accounts for the most mortality~     and DALY.55 Despite the magnitude of the problems associated with HAP, research on its health~     effects has been hindered by lack of accurate data on exposure and health outcomes. There are~     few studies available that report HAP exposures and development of adverse pregnancy outcomes~     from households using biomass fuels.~   "
89582|NCT02394561|"~     A study to evaluate the differences in the efficacy and safety of secukinumab between~     Cw6-negative and Cw6-positive patients with moderate to severe plaque-type psoriasis~   "
91684|NCT02367092|"~     The purpose of this study is to learn more about the effects of exercise on functional status~     and outcomes on patients with end-stage liver disease on the liver transplant waiting list~     and who have undergone liver transplantation.~   "
89586|NCT02394509|"~     The purpose of this study is to determine the feasibility and efficacy of the home-based~     cognitive self-management program HOBSCOTCH delivered at four New England medical centers.~     It will test the long-term impact and cost-effectiveness of HOBSCOTCH, and whether it can be~     delivered from a distance utilizing e-health tools for parts of the program.~   "
89587|NCT02394496|"~     Based on these results it can be envisioned that the majority of endocrine-responsive~     post-menopausal breast cancer patients will be treated with an AI as adjuvant therapy~     (front-line, switching or extending) and/or as first-line management of metastatic breast~     cancer.~   "
89588|NCT02394483|"~     Double blind, placebo controlled, ascending single oral dose, sequential group study. Forty~     subjects will complete the study in 5 cohorts (Groups A to E), each group consisting of 8~     subjects. Each subject will be on study for approximately 6 weeks. Each subject will~     participate in one treatment cohort only, residing at the Clinical Research Unit (CRU) from~     Day -1 (the day before dosing) to Day 6 (120 hours post-dose). Each cohort will be dosed in a~     leading edge design in which two subjects will receive study drug (1 active and 1 placebo) on~     the first dosing day, and the last 6 will receive study drug (5 active and 1 placebo) on the~     second dosing day.~      All subjects will return for a post-study visit 8 to 10 days after the dose of study~     medication.~      Cohorts will be dosed at 2 weekly intervals. There will be a review of safety data, after the~     first two subjects have been dosed and before dosing of the subsequent six subjects. There~     will be a complete review of safety and pharmacokinetic data of each cohort prior to each~     dose escalation.~   "
89589|NCT02394470|"~     The purpose of this study is to validate non-invasive and user-friendly methods to monitor~     systemic and pulmonary congestion in heart failure patients.~      The primary objective is to validate the role of bioimpedentiometry, pulmonary and~     subcutaneous ultrasound, to assess changes in total body water in patients with heart~     failure. vs the gold standard technique of deuterium oxide dilution Secondary objectives are~      - to evaluate the applicability of bioimpedentiometry, pulmonary and subcutaneous ultrasound~     to monitor systemic, pulmonary and peripheral district congestion in relation with clinical~     and laboratory variables; 2)to analyze the organizational issues related to the use of these~     methods.~   "
89590|NCT02394457|"~     PDPH is a common problem after either intentional or unintentional Dural puncture. It is~     especially common in young female patients and in patients undergoing Lumbar Puncture using~     the typical kit containing large 20 gauge needles (1).~      Hypothesis is that Cosyntropin therapy is at least as effective as current conservative~     therapy (caffeine/fluid) and/or Epidural Blood Patch.~      Patients will be randomly assigned to undergo either: (1) EBP with IVF therapy or~     (2)Cosyntropin IV with IVF therapy. Endpoints will be a pain score that is given prior to the~     procedure, Emergency Department (ED) discharge pain score and post procedural day (PPD) day~     1, day 3 and day 7 pain and functional levels. Patients in Cosyntropin arm of the study may~     request crossover to EBP at anytime after a 24 hour assessment period is completed per~     Standard of Care for treatment of PDPH, in order to ensure no undue distress is placed on the~     patient in order to complete this study.~      Current treatments consist primarily of non-invasive treatment with intravenous fluids and~     caffeine therapy and invasive treatment by Epidural Blood Patch. Efficacy of Caffeine 300mg~     IV bis in die (BID) x 1d doses is approximately 70% (2). However this therapy has been linked~     to post-treatment seizures. EBP was originally thought to be 90% effective with repeat~     treatment efficacy approaching >96%. However more recent studies by Taivainen et al (3) have~     shown only a 61% rate of permanent cure. Additionally, EBP are contraindicated in patients~     with signs of increased intra-cranial pressure (ICP), coagulation issues, signs/symptoms of~     Central Nervous System (CNS) /systemic infection or local infection at the site of the EBP,~     thus resulting in decreased utility. Complications are also quite serious ranging from~     meningitis, spinal hematoma, repeat dural puncture, localized infection and vagal response to~     the procedure. EBP are not typically performed until after conservative measures have failed~     which leads to further prolongation of the patients decreased functional status and pain.~     Additionally, the cost of both treatments is substantial considering prolonged ED visits for~     conservative treatments often followed by the time and expense of an EBP.~      The goal of this investigation is to aid in the confirmation of case reports advocating the~     economy, efficacy and safety of synthetic Adrenal CorticTropin Hormone (ACTH) as a treatment~     of PDPH (4,5,6,7,8,9).~   "
89591|NCT02394444|"~     The aim of this study was to assess the impact of an early psychological intervention,~     Triadic parent-infant Relationship Therapy (TRT), on parenting stress, parental mental~     health, and preterm infant development in the motor, cognitive, emotional and behavioral~     domains at a corrected age of 18 months.~   "
89592|NCT02394431|"~     Sickle Cell Disease is a serious disease that is life-threatening for patients being~     homozygous for the SS form or heterozygous for the SC or βthal forms. The CHU Brugmann~     hospital currently regularly treats about 70 homozygous adult patients and this number is in~     constant augmentation.~      Sickle cell disease patients may develop a cardiomyopathy due to chronic anemia, the~     haemosiderosis risk or, less frequently, to coronary vaso-occlusive damages.~      The hypervolemia in patients with sickle cell disease causes an overestimation of the ejected~     left ventricular fraction measured by echocardiography, this parameter being very dependent~     of the blood volume.It has already been shown that the left ventricular ejection fraction was~     normal in most patients with sickle cell disease, but that its evaluation by parameters~     independent from the blood volume showed the existence of a dysfunction.~      Myocardial strain, as measured by speckle tracking, is a echographic evaluation method of the~     cardiac function, independent of the blood volume. This technique hasn't been used much in~     sickle cell disease patients. A study using 3D speckle tracking on a limited number of sickle~     cell disease patients failed to show a strain anomaly. Moreover, the study highlighted a~     higher global longitudinal strain in this patient population. The investigators find these~     data hard to explain and in contradiction with previous studies using other cardiac function~     evaluation techniques, independent from the blood volume.~      The primary goal of this study is thus~        -  to study the longitudinal strain by 2D echography~        -  to determine if anomalies of the longitudinal strain exist in sickle cell disease~          patients with a normal ejected left ventricular fraction, compared to a control group of~          healthy patients.~      The secondary goal of this study is to correlate, inside the sickle cell disease group, the~     possible strain anomalies with biological gravity parameters of the disease.~   "
89593|NCT02394418|"~     Assessment of sedative effects of sevoflurane, dexmedetomidine and propofol on the clinical~     course of delirium, SIRS and neuroinflammation in mechanically ventilated patients using~     CAM-ICU scale, GSK-3beta and protein S100b in serum.~   "
89594|NCT02394405|"~     Assessment of the severity of oxidative stress caused by the on-pump and off-pump CAGB using~     mtDNA, nDNA, carbonilated proteins, nitrotyrosine, oxy-LDL, S100b-protein.~   "
89595|NCT02394392|"~     1. Investigate the clinical characteristics, medication satisfaction and quality of life of~          anti-hypertensive drugs in Korean hypertensive patients~        2. Observe the changes of medication satisfaction and compliance in patients after~          switchting to Fimasartan~   "
89596|NCT02394379|"~     To evaluate the incidence of IOL vaulting (ie, position change) of the Trulign™ Toric IOL~     following cataract surgery.~   "
89597|NCT02394366|"~     Delayed wound healing leads to increased risk for infection, and thus increased risk for~     morbidity and mortality. Skin oxygen delivery and peripheral blood flow predict wound~     healing. The investigators will conduct a double-masked, placebo-controlled cross-over~     clinical pilot trial in order to evaluate the effects of a topical, homeopathic/herbal salve~     (Original Healing Salve, Puremedy, Inc.) on skin oxygenation and peripheral blood flow.~   "
89598|NCT02394353|"~     Aim: To compare prospectively two bariatric surgery techniques: sleeve gastrectomy (SG) vs~     gastric bypass (GB) in the evolution of nonalcoholic fatty liver disease (NAFLD) measured by~     the transient elastography in the first year. Methods: This is a randomized clinical trial~     with morbidly obese patients, between 18-60 years old from a Federal Hospital, Ministry of~     Health, Brazil. Patients were divided into 2 groups: group 1 - SG (n = 30) and group 2 - GB~     (n = 30). The randomization was made by lots. In the GB the investigators created 30 ml~     pouch, with a pancreatic and an alimentary limb of 1 meter, and a calibrated~     gastroenterostomy (1.5 cm diameter). In SG the investigators calibrated the gastric tube with~     a bougie number 32 (70 ml). The variables were compared one week before surgery and in the~     postoperative time (1, 3, 6 and 12 months). The variables were: patient anthropometry,~     laboratory tests and the transient liver elastography.~   "
89599|NCT02394340|"~     This is an open-label, maximal use study evaluating the drug interaction potential of~     luliconazole cream 1% in subjects with tinea pedis and tinea cruris~   "
89600|NCT02394327|"~     Early laparoscopic cholecystectomy is the current standard therapy for acute cholecystitis,~     but temporary decompression of the gallbladder (GB) through percutaneous or endoscopic route~     can be required to alleviate inflammatory process and reach an appropriate time for elective~     surgery in patients with high operative risk or marked local inflammation or organ~     dysfunction. Also preoperative endoscopic retrograde cholangiopancreatography (ERCP) is often~     needed because common bile duct (CBD) stone is accompanied in patients with acute~     cholecystitis at reported rate from 7-20%.~      Two-steps approach of percutaneous transhepatic GB drainage (PTGBD) followed by ERCP or vice~     versa has been performed for the treatment of acute cholecystitis with concomitant CBD stone~     who are not suitable for urgent cholecystectomy. However single-step drainage of CBD and GB~     through ERCP and endoscopic transpapillary GB drainage (ETGD) using nasocystic tube or~     plastic stent has alternatively been attempted in patients who have contraindications for~     PTGBD. In clinical practice, many endoscopists have hesitated to perform ETGD because of its~     relatively low technical success rate and specific concern about post-ERCP adverse event but~     it minimizes catheter keeping duration, and provides effective clinical improvement via~     physiologic route.~      Currently there are scarce data on if ETGD using nasocystic tube or plastic stent are~     comparable in terms of clinical efficacy and safety.~   "
89601|NCT02394314|"~     A Phase 1, single dose study with 8 cohorts of ascending doses designed to evaluate the~     safety and pharmacokinetics of MEDI0382 in healthy volunteers.~   "
89602|NCT02394301|"~     ENDURE is a prospective, observational study aimed to document clinical response and side~     effects associated with compounded psoriasis medications when prescribed as routine care. As~     a secondary initiative, this study will assess methotrexate systemic absorption and toxicity~     in patients prescribed a methotrexate-containing compounded formulation.~   "
89603|NCT02394288|"~     This study will determine the extent of high-sensitivity cardiac troponin (hs-cTn) release in~     patients without cardiac risk factors undergoing extremity orthopedic surgery. This study~     will provide important evidence on how to interpret postoperative cardiac troponin~     elevations.~   "
89604|NCT02394275|"~     The primary goal of this proposal is to study the outcome of patients with recurrent~     Clostridium Difficile Infection (CDI) treated with frozen Fecal Microbiota Transplantation~     (FMT) in an open-labelled controlled trial. The specific objectives are to evaluate the~     safety of FMT and to determine the clinical response, treatment failure and relapse rate in~     patients treated with frozen-and-thawed FMT; to assess the functional health and well-being~     of patients in each arm using the validated tool, and to determine the feasibility of~     providing standardized FMT in multiple centres across Canada, including community hospitals.~     The metagenomics will also be conducted from the stool samples collected from select patients~     from each arm: pre and post treatment and the matching donors. The metagenomics data will be~     used to determine the bacteria which may have contributed to the cure of CDI.~   "
89605|NCT02394262|"~     Currently, cardiac computed tomography angiography (CCTA) is a well-implemented non-invasive~     diagnostic imaging modality in patients with stable chest pain. Besides conventional~     CT-reading, CCTA is also capable to identify several morphologic and geometric~     characteristics of atherosclerotic plaques. Recently, the investigators showed that the use~     of semi-automated plaque quantification algorithm identified parameters predictive for acute~     coronary syndrome on top of clinical risk profiling and conventional CT-reading. In addition,~     several atherotrombosis biomarkers, like high-sensitivity cardiac troponins, are described as~     related to coronary artery disease and cardiovascular events. Prospective data with~     sequential analysis of atherosclerotic plaques combined with different atherothrombosis~     biomarkers are currently lacking, but will provide important clues about the pathophysiology~     of plaque progression and atherothrombosis.~   "
89606|NCT02394249|"~     Background of the study:~      A sedentary lifestyle and obesity are well known risk factors of type 2 diabetes. The major~     focus of current guidelines for type 2 diabetes prevention is on energy balance. Physical~     activity guidelines recommend at least 30 minutes/day of moderate to vigorous physical~     activity (MVPA). However, no advice is given how the other 23.5 hours of the day should be~     spent. Several recent epidemiologic studies suggest that excessive sitting, independent of~     moderate to vigorous physical activity, has detrimental health effects. Another possibility~     to sit less is by increasing low intensity physical activities as slowly walking and~     standing. A recent published study of Duvivier and colleagues suggests that sitting less and~     replacing it by slowly walking and standing has a better effect on insulin action and~     cardiovascular risk factors than the combination of one hour MVPA per day and sitting the~     rest of the day in healthy subjects (Duvivier et al. PLOS ONE 2013). Until now this research~     is not performed in subjects with overweight/obesity.~      Objective of the study:~      To assess the effect of low intensity physical activity on plasma insulin levels, cognition~     and mood in subjects with overweight/obesity~      Study population:~      21 subjects between 40-80 years old with overweight/obesity~      Intervention:~      2 activity regimes of 4 days: a sitting regime and a sit less regime~   "
89607|NCT02394236|"~     Thus, the purpose of the present study was to evaluate the effects of continuos exercise~     training (CET) and interval exercise trainining (IET) on oxygen uptake efficiency slope~     (OUES) in patients with coronary artery disease.~   "
91685|NCT02367079|"~     To investigate the effect of hand massage, switched on diathermy or sham/switched off~     diathermy on DOMS in a group of athletes suffering DOMS after a ski mountaineering race.~   "
89608|NCT02394223|"~     Primary objective :~      The primary objective is to evaluate the diagnosis performance of FFOCT for cancer detection~     in patients undergoing TRUS prostate biopsy, as compared to standard pathological evaluation.~      Secondary objective:~        -  Evaluate predictive values of FFOCT for cancer detection on prostate biopsy cores~        -  Evaluate the value of FFOCT for cancer characterization on prostate biopsy cores~        -  Evaluate the reproducibility of FFOCT evaluation for cancer detection on prostate biopsy~          cores~        -  Evaluate the learning curve of FFOCT evaluation on prostate biopsy cores~        -  Evaluate FFOCT procedure time~   "
89609|NCT02394210|"~     Post-authorisation prospective follow-up study to assess the clinical impact on time to~     progression (TTP) from the start of anti- multiple myeloma treatment at the onset of~     asymptomatic relapse/biological progression versus start of treatment at the time of~     symptomatic relapse.~   "
89610|NCT02394197|"~     In the context of malaria elimination in the Americas, solid evidence is necessary of the~     effectiveness of anti-malarial control measures delivered to the affected individuals. In the~     Americas, most P. vivax infections are sensitive to Chloroquine (CQ) and Primaquine (PQ), and~     the most effective treatment worldwide comprises administration of a total dose of 25~     milligrams (mg)/Kilogram (kg) weight of CQ distributed in three days and 3.5 mg/kg body~     weight of PQ administered during 14 days (T14). In Mexico, CQ and PQ have been administered~     since the late 50´s to treat malarious patients. In 1999 the National Malaria Control Program~     implemented an intermittent single doses treatment (ISD) as part of the overall strategy.~     After the blood sample was obtained for diagnosis of symptomatic patients, a single combined~     dose of CQ and PQ was administered, and after malaria infection confirmation, additional~     doses were administered monthly alternating each three months, during 3 years. Although, the~     number of malaria cases were reduced in most affected regions, in Southern México, many~     patients under ISD present recurrent blood infections, presumably relapse episodes were~     observed.~      Working hypothesis: the administration of ISD is low effective to eliminate relapse episodes~     and its effectiveness depends on the coincidence of the relapse episodes and the~     administration of the medication), while the T14 is highly effective to eliminate P. vivax~     primary and relapse infections.~      Objective: To determine the antimalarial drug effectiveness of the ISD and T14, based on CQ~     and PQ for the treatment of uncomplicated P. vivax infection (primary and recurrent blood~     infections) in Southern Mexico.~      Methods: The study was carried out in malaria affected communities of Southern Mexico,~     following the WHO recommendations for clinical studies. Symptomatic patients diagnosed with~     P. vivax infection that meet the inclusion criteria, were invited to participate. After they~     accepted by informed consent, patients were semi-randomized and treated with either T14~     (14-day treatment) or ISD (18 intermittent single doses of CQ-PQ). Clinical, parasitological,~     molecular and serological parameters were monitor over a 12-month follow up period to~     evaluate the treatment outcomes to cure blood infection and relapsing episodes. The study was~     conducted from February-2007 to October-2010. The results of this study will be used to~     assist the Ministry of Health of México in assessing the current national treatment~     guidelines for uncomplicated P. vivax malaria~   "
89611|NCT02394184|"~     The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve~     replacement (TAVR) in patients with bicuspid aortic valve stenosis.~   "
89612|NCT02394171|"~     Health Is Power (HIP) was a community based health intervention designed to increase physical~     activity among women of color. It was funded by a grant from the National Cancer Institute of~     the National Institutes of Health. The purposes of the study were (1) to determine whether a~     6 month, group cohesion intervention is more effective for increasing physical activity~     compared to a 6 month, group cohesion comparison targeting improving dietary habits (2) to~     determine whether residence in a neighborhood supportive for physical activity helped women~     maintain their physical activity from 6 to , and (3) to determine whether this effect was~     transculturally replicable.~   "
89613|NCT02394158|"~     Study Hypothesis: Intervention with metformin therapy early in pregnancy will prevent~     gestational diabetes mellitus recurring in previously affected pregnancies.~   "
89614|NCT02394145|"~     Patients with end stage renal disease (ESRD) on hemodialysis (HD) exhibited higher platelet~     reactivity to clopidogrel than did those with normal renal function. We recently reported~     platelet inhibition by ticagrelor was faster and markedly greater than by clopidogrel with~     onset dosing regimen in patients with ESRD on HD. However, few studies have been conducted~     genetic influence in high platelet reactivity in patients with ESRD on HD.~   "
89615|NCT02394132|"~     The purpose of this study is to investigate the effectiveness of using either radiotherapy~     (RT) or Imiquimod (ImiQ) to treat the Lentigo Maligna (LM), when surgery is not possible, is~     refused, or fails.~      Surgery is the standard treatment for people diagnosed with LM. However for some people, it~     may not be possible due to the location of their LM lesion(s).~      Currently, the Australian and New Zealand Melanoma Treatment Guidelines recommend~     radiotherapy for the treatment of LM however there is no clinical trial evidence for this and~     a trial is needed to prove which treatment is safer and more effective. Some clinicians may~     also recommend the use of a cream called Imiquimod. It is approved and widely used in~     Australia to treat solar keratosis, superficial basal cell carcinoma, external genital warts,~     and perianal warts. Although not currently licensed for treatment use in LM, there is some~     evidence to suggest that it is both safe and effective in treating LM.~      This trial will scientifically evaluate and compare these two treatments in a controlled~     clinical setting.~   "
89616|NCT02394119|"~     Open-label, two-parallel-arm, controlled randomized clinical trial testing the superiority of~     Ofatumumab over Rituximab in maintaining steroid- and calcineurin-inhibitor-free disease~     remission in SD-INS.~      Eligible participants will enter a 1-month run-in period, during which instruction on urine~     collection and dipstick readings will be carefully reviewed, compliance assessed, and therapy~     with RAS inhibitors withdrawn and, in hypertensive children replaced by other~     anti-hypertensive drug.~      After run-in period, children will be randomized to either the intervention arm (Ofatumumab)~     or the comparator arm (Rituximab).~      After infusion of intervention or comparator, steroids will be maintained at initial dose for~     30 days and then tapered off by 0.3 mg/kg per week until complete withdrawal.~      One week after the steroid withdrawal calcineurin inhibitors will be decreased by 50% and~     withdrawn within 2 additional weeks.~      All patients will be followed for up to 24 months. In case of relapses during the study (see~     outcome section for definition) patients will be treated with 60 mg/m2of prednisone p.o. in~     order to achieve remission. At remission, patients will be treated with another infusion of~     either Oftumumab or Rituximab, according to the initial randomization.~      After infusion of intervention or comparator, steroids will be maintained at initial dose for~     30 days and then tapered off by 0.3 mg/kg per week until complete withdrawal.~      One week after the steroid withdrawal calcineurin-inhibitors will be decreased by 50% and~     withdrawn within 2 additional weeks. This strategy will be repeated to treat full relapses~     during the study.~   "
89629|NCT02393950|"~     The study is a dose escalation study with 8 planned dose levels. The study is a 4-period~     crossover design where each healthy volunteer will be randomised to receive three dose levels~     of ODM-106 (single doses) and one dose of placebo. The study will look at the~     pharmacokinetics (how the body handles the drug) and pharmacodynamics (how the drug affects~     the body) of ODM-106.~   "
89617|NCT02394106|"~     Double-blind, two-parallel-arm, placebo-controlled randomized clinical trial testing the~     superiority of Ofatumumab versus placebo in the treatment of children with DR-INS.~     Participants will be stratified according to eGFR at enrollment.~      Eligible participants will enter a 3-months run-in period, during which instructions on urine~     collection and dipstick readings will be carefully reviewed, compliance assessed and any~     immunosuppressive therapies withdrawn according to the following schemes:~        -  prednisone will be tapered off by 0.3 mg/kg per week until complete withdrawal;~        -  calcineurin inhibitors and mofetile mycophenolate will be decreased by 50% and withdrawn~          after 2 additional weeks In order to minimize the risk of complications of uncontrolled~          INS a treatment with ACE-inhibitor at 6 mg/m2 will be maintained or started in all~          patients.~      After run-in period, children will be randomized to the intervention arm (Ofatumumab) or~     comparator arm (placebo). Randomization will be stratified by eGFR at randomization: ≥90 and~     <90 ml/min/1.73 m2.~      All patients will be followed up to 12 months and they will leave the study at time of~     relapse.~      Relapse will be defined as uPCR ≥2000 mg/g (≥200 mg/mmol) or ≥ 3+ protein on urine dipstick~     for 3 consecutive days.~   "
89618|NCT02394093|"~     To evaluate the bioavailability of a single oral dose of the Acetylsalicylic Acid containing~     dry powder 500 mg in comparison to the bioavailability of a single oral dose of aspirin~     tablets and aspirin effervescent tablets in healthy adults.~   "
89619|NCT02394080|"~     The purpose of this study is to collect safety and performance data on the use of the~     Photodynamic Bone Stabilization System (PBSS) when used to provide stabilization and~     alignment for the treatment of acute humerus fractures.~   "
89620|NCT02394067|"~     This prospective study will use magnetic resonance imaging of patients with Idiopathic~     Intracranial Hypertension (IIH), to determine if the common radiological finding of~     transverse venous sinus stenosis can be reversed with standard of care medical treatment of~     IIH.~   "
89621|NCT02394054|"~     It has long been established that interpersonal relationships can have a profound impact on~     health and well-being. Yet, the investigators are still learning about the complex biological~     processes that contribute to positive social interactions and the ability to develop and~     maintain social relationships. Recent research has begun to focus on vasopressin, a~     neuropeptide that is naturally produced in the hypothalamus, because administration of this~     neuropeptide has been associated with empathy, cooperation, memory of social stimuli (e.g.,~     faces), and brain activity in neural regions associated with social and emotional processes.~     To date, several aspects of vasopressin's effects on social behavior have been unexplored. As~     such, the overarching goal of this project is to examine the effects of intranasal~     vasopressin on several tasks involving learning and social processes. In addition, the~     investigators will explore associated neural activity through functional magnetic resonance~     imaging (fMRI). Results from the study will inform our understanding of the neurobiology of~     socioemotional processes.~      The investigators hypothesize that compared to placebo, vasopressin will improve deception~     detection, increase empathy and altruism, enhance responses to photo stimuli of primary~     caregivers, and improve learning when the subject has a prosocial goal of teaching another~     person. These effects will manifest in behavioral and neural activity. It is also~     hypothesized that main effects will not be found for vasopressin, but rather, analyses of~     relevant moderators will elucidate these findings.~   "
89622|NCT02394041|"~     The principal objective of the trial is to demonstrate that acupuncture could reduce the~     caesarean section rate for cervical dystocia.~      Secondary objectives:~      To demonstrate that acupuncture can:~        -  reduce morbidity, fetal mortality and duration of childbirth;~        -  reduce the cost of care, due to diminution of caesarean sections and duration of~          obstetric labor;~        -  to evaluate the tolerance.~   "
89623|NCT02394028|"~     This is a multicenter, Phase 3, double-blind, placebo-controlled study evaluating the~     efficacy, safety, and tolerability of etrolizumab compared with placebo during induction and~     maintenance treatment of moderate to severely active CD in participants who are refractory or~     intolerant to corticosteroids (CS), immunosuppressants (IS), or anti-tumor necrosis factors~     (anti-TNFs) or have inadequate response to anti-tumor necrosis factor (TNF-IR). Participants~     who enroll on the basis of refractory or intolerance to CS and/or IS may have been previously~     exposed to anti-TNFs or be naïve to anti-TNFs. The study period will consist of Screening~     Phase (up to 35 days) plus (+) 14-week Induction Phase + 52-week Maintenance Phase + 12-week~     Safety Follow-up Phase. At Week 14 (end of Induction Phase), participants achieving decrease~     of 70 points in Crohn's Disease Activity Index (CDAI) from baseline (CDAI-70 response)~     without the use of rescue therapy will continue to the Maintenance Phase.~   "
89624|NCT02394015|"~     Retrospective Study to Analyze the Efficacy and Safety of Trabectedin and Pegylated Liposomal~     Doxorubicin (PLD ) in the Treatment of Patients With Platinum-sensitive Recurrent Ovarian~     Cancer (ROC), According to SmPC.~   "
89625|NCT02394002|"~     The relation between burst and suppression periods in transcranial and direct cortical~     recorded EEG with cortical amplitudes median nerve somatosensory evoked potentials is~     studied.~      60 patients are included in this study: 15 patients undergoing brain tumor surgery, 15 spine~     surgery (University Hospital Düsseldorf) and 30 patients during general surgical procedures~     (Helios Klinikum Wuppertal).~   "
89626|NCT02393989|"~     Background: This 3-year clinical trial compared the performance and post-operative~     sensitivity of a posterior resin composite with that of bonded-amalgam in large sized~     cavities. Additionally, it was evaluated whether resin composite could be an alternative for~     bonded amalgam.~      Methods: This was a randomized clinical trial. Patients in need of at least two posterior~     restorations were recruited. Authors randomly assigned one half of the restorations to~     receive bonded-amalgam and the other half to composite restorations. Forty bonded-amalgams~     and composites were evaluated for their performance on modified Ryge criteria and~     post-operative sensitivity using VAS for 36-months.~   "
89627|NCT02393976|"~     Compare the results in terms of morbidity, mortality and hospitalization among patients with~     input from immunonutrients and patients with enteral nutrition intake of high calorie and~     high protein undergoing colorectal surgery within a multimodal rehabilitation program.~   "
89628|NCT02393963|"~     This is a randomized, double blinded, controlled trial in patients undergoing elective Total~     Knee Arthroplasty (TKA) and Total Hip Arthroplasty (THA). The study group will receive~     intra-articular Tranexamic Acid (TXA) while the control group will receive normal saline~     placebo.~   "
89631|NCT02393924|"~     This disease registry is a prospective, multicenter non-interventional study designed to~     observe the different anticancer treatment regimens and their sequencing throughout the~     course of the disease in participants with unresectable locally advanced breast cancer (LABC)~     or metastatic breast cancer (mBC) and to describe the clinical outcome for each treatment~     regimen measured as progression-free survival.~   "
89632|NCT02393911|"~     Currently, the pathogenesis of Localized Provoked Vulvodynia (LPV) has not been elucidated.~     Few observations may point to involvement of the microbiome: the association of LPV with~     preceding chronic recurrent candidiasis, and the reports of the beneficial effect of a diet~     avoiding oxalate on Vulvodynia.~      Studies in the new field of microbiome research focus on the composition of overall~     microorganisms in our body and their impacts on our health. Changes in the composition of the~     vaginal microbiota (dysbiosis) have been linked with different health and disease states. We~     have also shown recently that women can be divided into 2 groups according to the composition~     of their vaginal microbiome.~      The proposed study will compare the vaginal microbiome of women with severe LPV, not treated~     by diet and otherwise healthy, to women without LPV (we will also compare our results to the~     NIH HMP data). Vaginal pH and date of menstrual cycle will be checked. We propose that~     dysbiosis in the vaginal microbiota may trigger the development of LPV.~   "
89633|NCT02393898|"~     The purpose of this study is to evaluate the safety and efficacy in the frontline treatment~     of ovarian cancer in participants 70 years of age and older in routine clinical practice in~     Belgium. Bevacizumab will be used in combination with carboplatin/paclitaxel followed by~     bevacizumab as maintenance in accordance with the Summary of Product Characteristics (SmPC).~   "
89634|NCT02393885|"~     The objective of this study is to establish the safety and effectiveness of a dual epicardial~     and endocardial ablation procedure for patients presenting with Persistent Atrial~     Fibrillation or Longstanding Persistent Atrial Fibrillation~   "
89635|NCT02393872|"~     The aim of the Feel4Diabetes-study is to develop, implement and evaluate a community-based~     intervention aiming to create a more supportive social and physical environment to promote~     lifestyle and behaviour change to prevent type 2 diabetes among families from low and middle~     income countries and from vulnerable groups in high income countries in Europe.~   "
89636|NCT02393859|"~     B-precursor ALL is an aggressive malignant disease. Therapy is usually stratified according~     to risk characteristics to ensure that appropriate treatment is administered to patients with~     high-risk of relapse. In general, pediatric treatment regimens are more intense than those~     employed in adults and include courses of combination chemotherapy. Standard of care~     chemotherapy is associated with considerable toxicity. There is a lack of novel treatment~     options for subjects who relapse or are refractory to treatment. Therefore, innovative~     therapeutic approaches are urgently needed. Blinatumomab is a bispecific single-chain~     antibody construct designed to link B cells and T cells resulting in T cell activation and a~     cytotoxic T cell response against CD19 expressing cells. This study will evaluate the~     event-free survival (EFS) after treatment with blinatumomab when compared to standard of care~     (SOC) chemotherapy. The effect of blinatumomab on overall survival and reduction of minimal~     residual disease compared to SOC chemotherapy will also be investigated.~   "
89637|NCT02393846|"~     The aim of this study is to analyse the effect of ketoprofen gel in patients presented with~     ankle sprain to the emergency department.~   "
89638|NCT02393833|"~     The serum protein research study is a substudy of the core study 'Maintenance Chemotherapy in~     Hormone Non-responsive Breast Cancer'. This substudy is an evaluation of blood proteins and~     their relationship to breast cancer treatment. It will assess the levels of Vascular~     Endothelial Growth Factor (VEGF), Soluble HER2 Protein (NRP, neu-related protein) and~     Vascular Cellular Adhesion Molecule-1 (VCAM-1) in serum samples of patients' blood at~     different time points. The goal is to evaluate differences in serum levels between patients~     receiving the maintenance chemotherapy and those who do not. The serum levels will be also~     examined to determine if they vary during the three year period of evaluation. In addition,~     the serum levels of patients who have a recurrence of their breast cancer will be compared~     with those who remain disease free. The information obtained from these studies will enable~     breast cancer physicians to better tailor therapies for future patients.~   "
89639|NCT02393820|"~     Open-label, multicenter, single arm phase II study, set up in collaboration with the REFCOR,~     evaluating the activity and safety of single agent pazopanib in recurrent or metastatic~     tumors in salivary gland including adenoid cystic carcinoma (ACC) and to exploring the~     activity and safety of pazopanib in non-adenoid cystic carcinoma (non-ACC).~   "
89640|NCT02393807|"~     The current study will investigate the relative bioavailability of a spray dried dispersion~     solid dose formulation of PF 06260414 administered as a single oral dose of 30 mg of PF~     06260414 relative to a single oral dose of 30 mg of PF 06260414 administered as a~     nanosuspension under fasted or fed conditions in healthy adult subjects.~   "
89641|NCT02393794|"~     Study combination use of cisplatin plus romidepsin and nivolumab in metastatic triple~     negative breast cancer (TNBC) or BRCA mutation-associated locally recurrent or metastatic~     breast cancer~   "
89642|NCT02393781|"~     The aim of this prospective study is to assess the prognostic value of bioactive plasma~     adrenomedullin (ADM) in 600 patients with severe sepsis or septic shock in an international~     multicenter study and to validate the findings concerning the association of ADM~     concentration and the use of vasopressor therapy, organ failure and outcome.~   "
89643|NCT02393768|"~     In this study, the investigators will determine whether patients with documented~     atherosclerosis are characterized by specific epigenetic changes in circulating cells of the~     innate immune system, compared to patients without atherosclerosis.~   "
89644|NCT02393755|"~     This phase I/II trial studies the side effects and best dose of nintedanib when given~     together with capecitabine and to see how well they work in treating patients with colorectal~     cancer that has not responded to previous treatment (refractory) and has spread to other~     places in the body (metastatic). Nintedanib may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth. It may also block the growth of new blood vessels~     necessary for tumor growth. Drugs used in chemotherapy, such as capecitabine, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Giving nintedanib with capecitabine~     may be a better treatment for colorectal cancer.~   "
89645|NCT02393742|"~     Nitric oxide (NO) is an essential molecule in the body that decreases with aging and causes~     reductions in vascular, movement (motor) and cognitive functions. This study will determine~     if daily oral supplementation (3 months) with a compound that increases NO in the body, i.e.,~     sodium nitrite, improves vascular, motor and cognitive function in older adults. The project~     also seeks to provide insight into the biological reasons (mechanisms) by which~     supplementation with sodium nitrite improves physiological function in older adults. Overall,~     this research will provide scientific evidence supporting the use of sodium nitrite for~     preserving physiological function and preventing clinical disease and disability with aging.~   "
89646|NCT02393729|"~     All the studies underlined the high frequency of co-morbid associations in specific learning~     disorders. Understanding the reasons for these associations could enable us to determine the~     cerebral bases that underlie each disorder. Their frequent association suggests the~     etiological bases are partly common, it seems logical to turn to explanatory models of~     various common specific disorders. The model recently proposed by Nicholson & Fawcett (2007)~     suggests a specific disorder of procedural learning. But the brain networks involved in this~     learning could be achieved separately. We intend therefore to study the neural networks~     involved in learning procedural and compare networks recruited among children with specific~     learning disorder alone or in combination (co-morbidity). The children included in the study~     have either a Developmental Dyslexia or a Developmental Coordination Disorder, or both. The~     procedure includes a neuropsychological evaluation and a brain MRI study with a morphological~     and a functional part. During fMRI the child realizes a automated motor task contrasting with~     a task involving learning procedural.~   "
89647|NCT02393716|"~     The purpose of this study is to demonstrate that the Endurant Evo AAA stent graft system is~     safe and effective for endovascular treatment of infrarenal abdominal aortic or aortoiliac~     aneurysms.~   "
89648|NCT02393703|"~     The purpose of this study is to isolate and analyze exosomes, which are tiny carriers of~     important proteins and nucleic acids that serve as messenger systems in the blood and tissue.~     Blood and tissue from patients with pancreatic cancer will be compared with blood and tissue~     from patients with noncancerous pancreatic disease. Including patients without cancer will~     allow the investigators to establish normal values, which currently do not exist. The~     investigators will then look to see whether exosome activity has a connection to disease~     recurrence and outcomes in patients. The results of this study will be the basis for future~     studies exploring this area.~   "
89649|NCT02393690|"~     This randomized phase II trial studies how well iodine I-131 works with or without~     selumetinib in treating patients with thyroid cancer that has returned or has spread from~     where it started to other places in the body. Many thyroid cancers absorb iodine. Due to~     this, doctors often give radioactive iodine (iodine I-131) alone to treat thyroid cancer as~     part of standard practice. It is thought that the more thyroid tumors are able to absorb~     radioactive iodine, the more likely it is that the radioactive iodine will cause those tumors~     to shrink. Selumetinib may help radioactive iodine work better in patients whose tumors still~     absorb radioactive iodine. It is not yet known whether iodine I-131 is more effective with or~     without selumetinib in treating thyroid cancer.~   "
89650|NCT02393677|"~     80 American Society of Anesthesiologists (ASA) grade I-II patients, 18-60 years old,scheduled~     for elective upper limb orthopaedic surgery under supraclavicular brachial plexus block, were~     included in this prospective study. The patients were randomly assigned to group R~     (Ropivacaine alone) and group RD (Ropivacaine and dexmedetomidine) (40 patients in each~     group). Group R received Ropivacaine 0.50% (30 cc) + placebo and group RD received~     Ropivacaine 0.50% (30 cc) + dexmedetomidine 1 µg/kg.~   "
89651|NCT02393664|"~     Lung cancer is the leading cause of cancer death in Taiwan and worldwide. With the~     advancement of thoracoscopic technique, thoracoscopic surgery has emerged as a reasonable~     option for the management of early-stage non-small cell lung cancer (NSCLC). Additionally,~     current lung cancer screening policy recruits increasing number of candidates requiring~     thoracoscopic lung resections because of lung nodules/tumors. Traditionally, intubated~     general anesthesia with one-lung ventilation using a double-lumen endotracheal tube or an~     endobronchial blocker has been considered mandatory in thoracoscopic surgery. However,~     adverse effects of intubated general anesthesia are not negligible. Recently, a nonintubated~     thoracoscopic technique has developed to reduce the adverse effects of intubated general~     anesthesia with encouraging results. Nonetheless, the role of nonintubated technique in~     thoracoscopic lung resection surgery in quality of postoperative recovery in not clear. As an~     enhanced recovery is the major goal of modern minimally invasive surgery, the investigators~     hypothesize that nonintubated thoracoscopic technique can facilitate and improve the recovery~     quality after surgery. To this end, the investigators will recruit 300 patients in subgroups~     including patients undergoing segmentectomy/lobectomy, wedge resection and geriatric patients~     in this two-year project. Patients will be randomly allocated in nonintubated and intubated~     groups and quality of recovery of all patients will be evaluated according the protocol of~     Postoperative Quality of Recovery Scale. In the meantime, the preoperative and postoperative~     cytokines will be compared between the groups as well as patients with different recovery~     scales.~   "
89677|NCT02393326|"~     Objective: To compare success rates of biodentine partial pulpotomy versus formocresol~     pulpotomy treatment of pulpally exposed lower primary molars.~      After caries removal resulted in a pulp exposure, the pulp at the exposed area is amputated~     to a depth of 2 mm. The wound surface is irrigated and dried. After homeostasis is obtained,~     an assistant drew lots to randomly allocate the case to either the biodentine partial~     pulpotomy (PP) or the formocresol pulpotomy (FP) group.~      The follow-up for clinical and radiographic evaluation will be carried out at 6-month~     intervals.~   "
89678|NCT02393313|"~     This study evaluates the Rayner T-flex Toric IOLs for spherical and astigmatic correction,~     and rotational stability in cataract surgery. 50 patients with cataract and corneal~     astigmatism >= 2 diopters will undergo cataract surgery, with implantation of Rayner toric~     intraocular lens. Post-operative examination will include IOL axis measurements and~     refraction.~   "
89752|NCT02392351|"~     The REDUCE HTN: REINFORCE study is being conducted to determine whether the Vessix Reduce™~     Catheter and Vessix™ Generator for the treatment of uncontrolled hypertension (off-treatment~     office systolic blood pressure ≥150 mmHg and ≤180 mmHg) shows acceptable performance at 8~     weeks when compared to a masked procedure (renal angiogram).~   "
89652|NCT02393651|"~     Rationale: About 80% of stroke patients suffer motor impairments, but current therapies have~     limited effects on motor recovery. Therefore, investigating new potential therapeutic~     approaches is crucial. Transcranial Direct Current Stimulation (tDCS) is a form of~     non-invasive electrical stimulation where a weak current is applied through electrodes over~     the scalp. This stimulation is known to (1) induce changes in neuronal excitability -which~     can last up to one day with late LTP-like plasticity protocols in a polarity and~     site-specific manner, and (2) facilitate motor learning and stroke recovery. So far, several~     pilot studies have reported beneficial results from tDCS in both subacute and chronic stroke~     patients, but it's still unclear how tDCS should be repeated over multiple days to optimally~     enhance recovery and training effects. Using a late LTP-like plasticity protocol could~     increase effectiveness of standard clinical care rehabilitation sessions and thus enhance the~     effects of rehabilitation. Therefore, the investigators want to investigate how late LTP-like~     plasticity tDCS affects rehabilitation in subacute stroke patients. The outcome of this study~     can provide important guidelines on effective motor therapy during stroke rehabilitation.~      Objective: Identify the effect of late LTP-like plasticity on motor rehabilitation during the~     subacute phase after stroke.~      Study design: Double-blinded, randomized between-subjects trials. Study population: Subacute~     stroke patients. Main study parameters/endpoints: The primary outcome measure is the upper~     limb motor function during the subacute phase after stroke.~   "
89653|NCT02393638|"~     This randomized-controlled study aims to evaluate the effectiveness of using ERCP mechanical~     simulator for training endoscopic sphincterotomy.~   "
89654|NCT02393625|"~     This is an open label multi center trial to determine the safety and efficacy of ceritinib in~     combination with nivolumab in ALK-positive NSCLC patients~   "
89655|NCT02393612|"~     Sarpogrelate hydrochloride, a selective 5-HT2A antagonist, has been widely used as an~     anti-platelet agent for the treatment of PAD. DP-R202 is a new Sarpogrelate hydrochloride~     product improved patient's convenience and disadvantage of dosage regimen of previous drug.~     The aim of this study was to compare the efficacy and safety of DP-R202 and Anplag® Tab in~     patients with PAD~   "
89656|NCT02393599|"~     The primary objective of this study is to determine if there are significant interactions~     between oral lorcaserin treatment concurrent with 20 and 40 mg intravenous (i.v.) cocaine~     infusions by measuring adverse events (AEs) and cardiovascular responses including heart rate~     (HR), blood pressure (BP), and electrocardiogram (ECG) (including QTc).~   "
89657|NCT02393586|"~     The purpose of this study is to evaluate the bactericidal activity against Mycobacterium~     tuberculosis of faropenem boosted with amoxicillin/clavulanic acid. Pharmacokinetics (PK) and~     Whole blood Bactericidal Activity (WBA) will be measured in healthy volunteers following~     single doses of faropenem plus amoxicillin/clavulanic acid.~   "
89658|NCT02393573|"~     Major surgery results in a stress- induced catabolic response, marked by post-operative~     insulin resistance, hyperglycemia and loss of body protein, which is associated with~     increased morbidity, mortality and adverse outcomes. There has been a great deal of research~     on different approaches to optimize post-operative insulin sensitivity including hormonal and~     nutritional interventions, minimally invasive surgical techniques and epidural anesthesia.~     However, the correlation between insulin resistance and body protein loss is not well~     understood. Metformin is the most widely used insulin sensitizing and blood glucose-lowering~     drug in treatment of type 2 diabetic patients. This study will: 1) estimate the correlation~     between insulin resistance and body protein loss in pre-diabetic lung/colorectal resection~     patients; 2) investigate whether the post-operative metabolic state can be improved by the~     pre-operative administration of metformin; and assess the impact of metformin on surgical~     complications and hospital length of stay. The results of this study will provide insight~     into the relationship between insulin resistance and post-operative adverse events and~     potentially suggest a novel approach to improve outcomes using Metformin, a drug already in~     wide clinical use.~   "
89659|NCT02393560|"~     The purpose of this study is to determine presence and volume of monosodium urate (MSU)~     crystal deposits as determined by dual-energy computed tomography (DECT) imaging in gout~     subjects treated with allopurinol with and without visible tophi.~   "
89660|NCT02393547|"~     This will be an open label clinical trial with all subjects receiving both lorcaserin and~     varenicline with a primary aim of reducing post cessation weight gain.~   "
89661|NCT02393534|"~     Doctors frequently speak with their patients over the telephone. Having a visit with a doctor~     over the telephone rather than face-to-face can be convenient for patients and allow them to~     save time and money on transportation and missed time from work. However, some patients may~     prefer seeing the doctor in person. In this study, we will study two groups of patients -~     some who have their visits with their doctor over the telephone and some who have them~     face-to-face. Using surveys and interviews, we will study if the groups differ in their~     satisfaction with their visit with their doctor after participating in the study for 6~     months. We will also look at doctor satisfaction with telephone visits, use of clinic~     resources and if patients received recommended care such as laboratory tests and vaccines~     during the study period.~   "
89662|NCT02393521|"~     The aim of this study was to investigate the efficacy of a self-administered vibration~     therapy treatment on neck pain, disability and pressure pain thresholds in patients with~     non-specific neck pain and myofascial trigger points (MTrPs). The investigators hypothesized~     that patients receiving vibration therapy would report less perceived neck pain, disability~     and present higher PPTs after receiving vibration therapy when compared to a control~     no-treatment group.~   "
89679|NCT02393300|"~     Previous studies in both the cardiovascular and orthopedic study have shown tranexamic acid~     (TXA) reduces blood loss and post-operative blood transfusion rate largely without major~     complications . In addition, many meta-analyses have confirmed these results . However, there~     is little information about comparison among the different routes of TXA administration in~     TKA. Therefore, this study has been designed to determine which administration route of TXA~     is more effective and safety.~   "
89680|NCT02393287|"~     The objective of this observatory is to evaluate the effecacy of Eribulin in patients with~     metastatic breast cancer on a recent prescription period.~      Part of the data collection will be retrospective and the other part will be prospective for~     patients started treatment by Eribulin between November 2014 and September 2015. It will~     allow a better assessment on the safety profile of this drug.~   "
89663|NCT02393508|"~     In this study, the investigators will be evaluating the impact of red blood cell age in~     patients receiving chronic blood transfusions in the outpatient setting. This study will have~     a double-bind, randomized trial design, meaning that the investigators and participants will~     not be told the group assignment at study enrollment.~      Study participants will be randomly divided into two groups (50% of participants in each~     group) by a computer generated block randomization schema. The 'fresh blood' group will~     receive blood units that are 7 or less from the time of donor collection, and the 'aged~     blood' group will receive blood units that are greater than 21 to 42 days from the time of~     donor collection. The number of units of blood transfused will be decided based on the~     participant's hemoglobin level before blood transfusion.~      The primary goal of our study is to compare annual red blood cell product use (the number of~     units given per patient in a year). The investigators will also be comparing groups to~     evaluate the transfusion reaction frequency, iron burden (based on the level of ferritin in~     the blood), overall transfusion and care cost difference, and participant time spent in~     outpatient departments.~      Our hypothesis is that use of fresh blood in chronically transfused patients will lead to a~     decrease the in red cell transfusion rate, with subsequent clinical benefits including~     reduction of transfusion reaction frequency and systemic iron burden.~      This study will be taking place within the Calgary Zone of Alberta Health Services only.~   "
89664|NCT02393495|"~     Different studies have been made in an attempt to reduce the pain and the duration of the~     process of outpatient insertion of the intrauterine device. in this trial, the investigators~     aim to insert the IUD under ultrasonographic guidance, which can help to reduce the pain,~     decrease the process of insertion, in addition, it reduces the incidence of malposition of~     IUD as well as the risk of complications.~   "
89665|NCT02393482|"~     The purpose of the study is to evaluate the impact on quality of life, psychological health,~     sexuality and chronic pain of therapies which determine amenorrhea in symptomatic women with~     endometriosis, through the administration of self reported questionnaires. Amenorrhea in the~     first group is caused by balanced assumption of estroprogestins, in the second group is~     caused by GnRHa-induced hypoestrogenism.~   "
89666|NCT02393469|"~     The Chronic Obstructive Pulmonary Disease (COPD) has shown a progressive increase of~     morbidity and mortality, suggesting that the lung as a single therapeutic target, has not~     contributed in the past 20 years, significant changes to the natural evolution of the~     disease. Direct treatment for systemic changes and comorbidities, in fact, the most~     responsible for high rates of treatment failure could mean a new hope of life for individuals~     with COPD. This research project characterized as interdisciplinary and multidisciplinary~     program will be headquartered in Pulmonary Rehabilitation of the Santa Cruz Hospital which~     has partnerships with local companies . Its main objective will be to analyze~     cardiorespiratory and functional capacity in COPD patients not rehabilitated and~     rehabilitated after the period from 02 to 12 months of treatment in a Pulmonary~     Rehabilitation program in the municipality of Santa Cruz do Sul - Rio Grande do Sul. Will be~     included in this survey of COPD patients who were referred to a rehabilitation program with a~     clinical diagnosis of disease. In research activities to assess cardiorespiratory and~     functional capacity of COPD, pre and post-program (02 and 12 months) are provided for~     Pulmonary Rehabilitation. The research subjects will also be subjected to physical exercise~     protocol as recommended by the GOLD (2009), a period of eight weeks, often 2x / week, where~     their vital signs are measured before, during and after each session. Thus, it is believed~     that it will be possible to refine the knowledge of mechanisms by which the judicious use of~     pulmonary rehabilitation can control the progression of COPD.~   "
89667|NCT02393456|"~     It has long been established that interpersonal relationships can have a profound impact on~     health and well-being. Yet, the investigators are still learning about the complex biological~     processes that contribute to positive social interactions and the ability to develop and~     maintain social relationships. Recent research has begun to focus on oxytocin, a neuropeptide~     that is naturally produced in the hypothalamus, because administration of this neuropeptide~     has been associated with increased trust, generosity, empathy, cooperation, memory of social~     stimuli (e.g., faces), and brain activity in neural regions associated with social and~     emotional processes. To date, several aspects of oxytocin's effects on social behavior have~     been unexplored. As such, the overarching goal of this project is to examine the effects of~     intranasal oxytocin on several tasks involving social processes. In addition, the~     investigators will explore associated neural activity through functional magnetic resonance~     imaging (fMRI). Understanding how oxytocin influences these aspects of social functioning~     will help to inform research that has begun to establish the potential for use of this~     neuropeptide in education as well as psychiatric disorders such as autism spectrum disorders~     and schizophrenia that are characterized by social deficits.~      The investigators hypothesize that compared to placebo, oxytocin will improve deception~     detection, increase empathy and altruism, and enhance responses to photo stimuli of primary~     caregivers. These effects will manifest in behavioral and neural activity. It is also~     hypothesized that main effects will not be found for oxytocin, but rather, analyses of~     relevant moderators will elucidate these findings.~   "
89692|NCT02393131|"~     Brain metastases are the most common brain tumors in adults. It is estimated that around~     10-30% of cancer patients would develop brain metastases during the course of their illness.~      Whole brain radiotherapy (WBRT) is the treatment of choice for the majority of patients with~     brain metastases. WBRT yields high radiologic response rate (27~56%) and is effective in~     rapid palliation of neurologic symptoms as well as prolongs time to neurocognitive function~     decline caused by intracranial lesions. By using conventional fractionation, 33% of patients~     developed late neurocognitive toxicity while memory impairment was the most common symptom.~     The incidence is even higher when a formal and sensitive neurocognitive assessment was~     prospectively evaluated. With more long-term survivors nowadays, it has become increasingly~     important to minimize neurocognitive function decline and maintain quality of life in~     patients with brain metastasis.~      The function of hippocampus is cooperation in learning, consolidation and retrieval of~     information and essential for formation of new memories. Bilateral and unilateral radiation~     injury of the hippocampus is known to alter learning and memory formation. Several~     preclinical studies support the hypothesis of hippocampus-mediated cognitive dysfunction by~     ionizing radiation. Clinical studies show increase in radiation dose to hippocampus is~     associated with subsequent neurocognitive function impairment in adult and pediatric~     patients. Furthermore, the preliminary result of Radiation Therapy Oncology Group (RTOG) 0933~     suggested hippocampal avoidance significant reduce the mean relative decline at 4 months from~     30% in historical cohort with WBRT to 7% in experimental cohort.~      Previous studies showed brain structures other than hippocampus are also associated with~     radiation-induced decline in neurocognitive function. There is presence of placebo effect for~     interventions seeking improvement in neurocognitive function. In present study, a single~     blind randomized phase II trial is designed to investigate the effectiveness of~     neurocognitive function preservation using conformal WBRT with or without hippocampal~     avoidance.~   "
91686|NCT02367066|"~     A study to assess the Pharmacodynamics of oral AR-C165395XX after Administration of Repeated~     Doses for 3 days in Subjects with Type 2 Diabetes Mellitus~   "
89668|NCT02393443|"~     One well-established cognitive theory propose a divide between social and non-social (i.e.,~     cognitive) systems. However, recent work suggests that traditionally social systems can be~     utilized to enhance cognitive performance. In this study the investigators aim to explore~     this cooperation between oft-competing systems by instructing participants to learn~     information because they will be subsequently tested (the nonsocial learning-for-testing~     condition), or because they will be teaching the information to someone else (the prosocial~     learning-for-teaching condition). This latter condition relies upon the mentalizing system,~     which is used to contemplate another person's mental state, rather than traditional memory~     systems. This implies that the mnemonic powers of the mentalizing system can be leveraged in~     the learning of a broad array of non-social topics. Furthermore, there is also an emerging~     literature on the role of oxytocin, a neuropeptide naturally produced in the hypothalamus, in~     memory that parallels the social/nonsocial split. Oxytocin may benefit the~     learning-for-teaching group both in terms of enhancing initial social motivation and~     efficient use of the mentalizing system and then also in terms of memory consolidation for~     this information learning under socially-motivated conditions.~      The investigators expect to replicate the basic learning-for-teaching effect such that those~     in the teaching condition will remember more than those in the testing conditions. They also~     expect an interaction between oxytocin administration and learning condition such that~     oxytocin administration should enhance learning for socially-motivated learning exclusively.~   "
89669|NCT02393430|"~     To investigate the clinical effect of rebamipide in chronic gastritis patients. Patients with~     chronic gastritis were randomly divided into the experimental group and the control group.~     The experimental group were treated with rebamipide 0.1g tid and optimization of life style,~     and the control group were only optimized their life style for 26 weeks. Upper~     gastrointestinal endoscopy was performed in all patients to evaluate the severity of~     gastritis by modified Lanza score (MLS) and the histology by the updated Sydney system before~     and after treatment.~   "
89670|NCT02393417|"~     This is a placebo-controlled, double-blind (subject, Investigator, and site staff with the~     exception of unblinded dedicated staff to handle study medication), phase 2a study with 3~     dose cohorts, randomized (concealed) to CANDIN or placebo (3:1). Main study will be up to 20~     weeks (10 doses administered every other week) or until a subject has complete resolution of~     all injectable common warts. Subjects who cannot tolerate dosing every 2 weeks due to a local~     tolerance issue may be injected at 3-week intervals for up to 10 doses, increasing the length~     of the study to 29 weeks. Subjects will be followed for 4 months after final injection(s) for~     evidence of new or reoccurring warts and for safety evaluation.~   "
89671|NCT02393404|"~     Objective: To compare the effectiveness of functional movement-power training (PT-FMT),~     functional movement training (FMT) alone and no intervention in improving balance strategies~     and performance among children with developmental coordination disorder (DCD).~      Design: A randomised controlled clinical trial. Sample: 87 children with DCD. Interventions:~     12 weeks of PT and FMT or FMT alone in the two intervention groups.~      Major outcomes: Sensory organisation test - balance strategy and composite scores; Movement~     Assessment Battery for Children - total impairment score and balance subscore; hand-held~     dynamometer measurements of lower limb muscle strength and time to peak force.~   "
89672|NCT02393391|"~     Neuropathic pain results from damage to or dysfunction of the peripheral or central nervous~     system, rather than stimulation of pain receptors. Diagnosis is suggested by pain out of~     proportion to tissue injury, dysesthesia (eg, burning, tingling), and signs of nerve injury~     detected during neurologic examination. Although neuropathic pain responds to opioids,~     treatment is often with adjuvant drugs (eg, antidepressants, anticonvulsants, baclofen,~     topical drugs). Neuropathic pain (e.g. phantom limb pain, CRPS, postherpetic neuralgia,~     postsurgical pain syndromes, CLBP etc.) remains a challenging condition to treat because it~     is commonly refractory to classical pharmacological and to surgical treatment approaches.~     Chronic low back pain (CLBP) is a widespread and costly problem for which few interventions~     are effective. An increased focus on the study of the nervous system and its involvement in~     pain disorders has documented complex neuronal activity and structural changes at a~     peripheral, as well as at spinal cord and cortical levels indicating a neuropathic element in~     CLBP. Accumulated evidence suggests that neuropathic pain in general and CLBP specifically~     might be associated to brain cortical plastic changes. Thus an ideal rehabilitative approach~     should aim to reverse them. In line with this idea, the investigators suggest an innovative~     noninvasive intervention aimed at alleviating neuropathic pain. New rehabilitative approaches~     have been proposed to try and reverse this cortical reorganization. Results of several~     studies have shown that motor cortex stimulation with epidural electrodes or repetitive~     transcranial magnetic stimulation (rTMS) or transcranial direct stimulation (tDCS) are~     effective in reducing pain in patients with central pain refractory to treatment.~     Transcranial direct current stimulation (tDCS) is an easily applied and safe technique by~     which brain activity can be modulated noninvasively and can decrease pain in patients with~     refractory central pain. The investigators hypothesized that focal-tDCS treatment personally~     customized to each patients basal neuronal network properties would result in both acute and~     long term pain relief for neuropathic pain patients.~   "
89673|NCT02393378|"~     The purpose of this study is to evaluate the efficacy and safety of namilumab in combination~     with existing methotrexate (MTX) over 24 weeks in patients with moderate to severe early~     rheumatoid arthritis (RA), diagnosed within 6 months and inadequately controlled by MTX~     alone.~   "
89674|NCT02393365|"~     Hepatitis C is caused by the hepatitis C virus (HCV) that causes inflammation of the liver~     that can lead to diminished liver function or liver failure.~      The number of chronically infected persons worldwide is estimated to be about 170 million~     that is 2.35% of the world population. Most people infected with the hepatitis C virus have~     no symptoms of the disease until the advanced stages of liver disease have occurred, which~     may take several years. The long-term impact of HCV infection is highly variable, from~     minimal changes to extensive fibrosis and cirrhosis with or without hepatocellular carcinoma~     (HCC).~      Advanced liver disease (ALD) can lead to significant clinical and economic consequences,~     including liver transplantation. HCV can reduce life expectancy and impair quality of life.~     HCV-related complications as well as the highly debilitating effects on patients represent a~     significant item of expenditure for the National Health Service. Because of the latency of~     infection, numerous country-specific population analyses suggest that HCV will cause an~     increasing number of liver-related deaths despite the dramatic drop in incidence and~     prevalence. These deaths will be related to prevalent HCV infection especially during and~     after World War II through indiscreet and widespread treatment with intravenous injection~     using contaminated syringes, needles and remunerated blood donors. Eradicating HCV infection~     can prevent the complications of HCV-related liver and extrahepatic diseases, including liver~     necroinflammation, fibrosis, cirrhosis, HCC, and death.~      Newly discovered hepatitis C virus (HCV) therapy with direct acting antiviral agents (DAA)~     like Simeprevir, sofosbuvir open a new chapter in the treatment of chronic hepatitis C. Those~     new treatment regimens promise oral dosing, higher SVR, shorter duration of treatment and~     fewer side effects. In a near future all patients should qualify for future all-oral~     therapies.~      However recent analysis have shown that increasing efficacy of treatment alone will not be~     able to reduce the HCV disease burden. The largest reduction in HCV-related morbidity and~     mortality can be obtained when higher efficacy therapies is combined with increased diagnosis~     and treatment rate. With a treatment rate of 10% it is possible to achieve a > 90% decline in~     total infections by 2030. This would require a 3-5 fold increase in diagnosis and/or~     treatment for most countries.~      The implementation of screening criteria for hepatitis C virus (HCV) such as targeting birth~     cohorts has potential effect on reducing the progression of hepatitis C virus (HCV) to~     advanced liver disease (ALD) and could avoid unnecessary high financial costs and preserve~     quality of life.~      Robust data from public health surveillance, surveys of the general and risk populations are~     required to make decisions in allocating public health resources to diagnose, assess and~     treat HCV infection.~      In Belgium no recent prevalence studies have been conducted. The most cited anti-HCV~     prevalence is 0.87% based on a study in the Flemish population published in 1997 but~     collected in 1994. In a French Belgian population there was an overall seroprevalence of~     0.6%. However, the population under study was not representative for the whole French~     community, because the recruited subjects were significantly younger.~      A survey among cirrhotic and hepatocellular patients in the French community revealed that~     20% of cirrhosis and 47% of hepatocellular cancer were related to hepatitis C. The diagnosis~     rate of HCV in Belgium is estimated at 43%, signifying that more than 50% of HCV patients~     remains undiagnosed.~      Several studies have already mentioned that aged population especially those born after~     Second World War are carriers of hepatitis C virus infection. Early detection of HCV~     infection and treating before progress to advanced liver disease (ALD) is an excellent~     opportunity to rationalize resource allocation and to improve patients' quality of life.~      Recently birth cohort screening recommendations were developed in the United States. In~     Belgium, no formal screening strategy exists. However the Belgian association of the study of~     the liver (BASL) recommends targeted HCV screening for high-risk populations (including~     individuals with a blood transfusion or major medical event prior to 1 july 1990, intranasal~     or IDU and dialysis patients) in addition to nontargeted screening among pre-operative~     patients and pregnant women. A birth cohort analysis based on a model suggests a birth cohort~     between 1950 and 1975 in Belgium. This population should reflect 70% of the viremic~     population.~      In this study, the investigators want to estimate the prevalence of hepatitis C in Belgium in~     2014 and to confirm the proposed targeted birth cohort and other risk factors. These data~     could provide an efficient source of identifying newly diagnosed patients as part of a~     national screening strategy.~   "
89675|NCT02393352|"~     This study evaluates the benefits of dry needling in trigger points on autonomic nervous~     system, photoelectric plethysmography, body composition in patients with fibromyalgia~     syndrome.~   "
89676|NCT02393339|"~     The aim of the study is to compare the efficacy of the pre-operative administration of~     Paracetamol and placebo in reducing postoperative pain after routine dental treatment in~     children. This study will be a prospective, placebo-controlled, randomized, double-blind~     trial. Patients in need of dental treatment with local anesthesia will take part in the~     study.~      Study group will receive syrup paracetamol 15 min before the dental treatment. Control group~     will receive placebo syrup, similar in color and viscosity, 15 min before dental treatment.~     the patient, the treating dentist, and the interviewer will be blind to the medication.~      Main outcome measure: one of the main investigators will interview the patient at three time~     points: immediately at the end of the treatment, one hour after taking the pre-operative~     analgesic and by phone 2.5 hours after taking the pre-operative analgesic. The patient and~     his parents will be asked if the child is crying (yes/no), complaining about pain (yes/no),~     needed a different kind of analgesics after the treatment (yes/no). In addition, each child~     will describe his ⁄ her feelings regarding postoperative pain, using the Wong-Baker Facial~     Rating Pain Scale~   "
89801|NCT02391714|"~     The purpose of this study is to determine whether Nitrous Oxide is effective in achieving~     pain control and satisfaction among nulliparous women getting the intrauterine device (IUD).~   "
89681|NCT02393274|"~     Extra-corporeal membrane oxygenation (ECMO) life support system can provide both cardiac and~     respiratory support to patients with heart and respiratory failure. It can save time for~     these organs to recovery or for these patients to receive further management. However, many~     patients will die in spite of ECMO support. One of the key factor is whether the blood flow~     provided by the ECMO can meet the requirement of organ perfusion. The adequacy of~     macrocirculation may be determined by arterial pressure and minute blood flow of ECMO.~     However, the adequacy of microcirculation remains as a major unresolved clinical problem.~     This is a prospective observational clinical trial. The sublingual microcirculation will be~     examined with the incident dark field video microscope within 6 hours after venoarterial ECMO~     placement, and then at 24 h, 48 h, 72 h, and 96 h. The severity of multiple organ injury and~     clinical data will be recorded as well. The major parameters of microcirculation include~     total small vessel density, perfused small vessel density, and microvascular flow index. The~     sublingual microcirculation will also be examined before weaning off ECMO, within 6 hours~     after ECMO removal, and then at 24 h, 48 h, and 72 h. Serum level of endothelial cell~     specific molecule-1 at specific time points will be examined. The data of 14-day mortality,~     28-day mortality, duration of ECMO support, and intensive care unit stay will be recorded.~     This study aims primarily to investigate the relationship between microcirculation and~     prognosis of these patients. This study will also investigate the relationship among serum~     level of endothelial cell specific molecule-1, microcirculation, and prognosis of these~     patients. Wish the results of this study can be applied in further research to help to~     improve the quality of ECMO care.~   "
89682|NCT02393261|"~     This prospective, randomized, controlled, multi-center clinical trial will evaluate the~     validity and security of 2500ml Huaren Peritoneal Dialysate compared with normal 2000ml~     peritoneal dialysate.~   "
89683|NCT02393248|"~     The purpose of this study will be to evaluate the safety, tolerability, and pharmacological~     activity of INCB054828 in subjects with advanced malignancies. This study will have three~     parts, dose escalation (Part 1), dose expansion (Part 2) and combination therapy (Part 3).~   "
89684|NCT02393235|"~     Factors affecting the success of the treatment of infertility can evaluate before and after~     embryo transfer in two stages. Most of the patients reach the embryo transfer stage.~     Unfortunately, the investigators are able to intervene very few of the factors that will~     affect the success of the post-transfer. All factors and treatments that affect the~     implantation is vital to identify. Basically, healthy vasculature is essential for a~     successful implantation. The investigators will try to understand relationship between~     vascular resistance and type of infertility. The investigators will examine whether the~     effect of the ovarian uterine and spiral artery resistance over infertility.~   "
89685|NCT02393222|"~     Stroke disease and cognitive impairment are common in patients established on haemodialysis~     (HD) for end-stage renal disease (ESRD). Further, initiation of HD appears to transiently~     increase the risk of stroke. The mechanism by which this occurs is not known.~      Using ultrasound, patient questionnaires and brain MRI our study will observe changes in~     cognition and cerebral blood flow whilst receiving HD compared to a non-dialysis day.~     Transient clinical and ultrasound alterations will be correlated to radiographic changes in~     cerebral perfusion and structure on MRI to determine the underlying mechanism for the~     increased stroke risk. The investigators will observe this effect in the immediate and longer~     term (12 months observation).~      A greater understanding will allow development of effective preventive strategies.~   "
89686|NCT02393209|"~     The purpose of this study is to determine the recommended phase 2 dose (RP2D) of TAK-117 when~     administered in combination with docetaxel in participants with non-small cell lung cancer~     (NSCLC) and to evaluate efficacy, safety, and tolerability of TAK-117 administered alone and~     in combination with docetaxel at the RP2D in participants with locally advanced or metastatic~     non-small cell lung cancer.~   "
89687|NCT02393196|"~     The investigators aimed to compare the methods colloid preloading and colloid coloading in~     terms of the incidence of maternal hypotension and impacts on neonatal outcomes. The second~     aim while planning the present study is to identify the method of the lowest adverse event~     for mother and infant and the simplest approach for the clinician.~   "
89688|NCT02393183|"~     This randomized clinical trial is designed to evaluate the effect of selected antioxidant~     vitamins and minerals supplement B-Carotene (6 mg) + Vit.C (200 mg) + Vit.E (200 mg) + Vit.~     Nicotinamide (20 mg) + Selenium (200 mic.)+ Zinc oxide (8 mg) + Copper oxide (1mg)~     +Mangeneschloride (1.8 mg) in patients with mild Graves' orbitopathy according to EUGOGO~     classification.~   "
89689|NCT02393170|"~     On-going rehabilitation is needed to maintain and improve the weaker upper extremity~     following stroke. Community rehabilitation programs for stroke individuals in the chronic~     stage are often difficult to be implement. Consequently, many individuals remain without~     structured interventional programs. Self-training programs, where individuals can~     independently continue to exercise at home, might answer this challenge. However, since~     exercising alone is boring and not motivating, individuals often stop the prescribed~     exercises and remain inactive. The use of video-games for self-training might answer this~     challenge.~      Therefore, the investigators aimed to assess the feasibility of using video-games for~     self-training after stroke. Specifically the investigators aim to compare the (1) training~     time, (2) satisfaction and (3) effectiveness of a self-training program using video-games~     compared to a traditional self-training program.~   "
89690|NCT02393157|"~     The purpose of this study is to determine the safety of administering obinutuzumab as a~     single agent alone and in combination with ifosfamide, carboplatin, and etoposide (ICE)~     chemotherapy and determine the response rate of this treatment for children, adolescents and~     young adults (CAYA) with relapsed CD20 positive B-cell Non-Hodgkin Lymphoma (B-NHL).~   "
89691|NCT02393144|"~     Primary aim of this study is to analyse contemporary labor patterns by measuring rate of~     dilatation and head descent via transperineal ultrasonography. Labor curves will be generated~     using data regarding rate of dilatation, head-descent obtained via transperineal~     ultrasonography. Factors which are known to effect duration of labor will be taken into~     account.~   "
89832|NCT02391298|"~     The aim of this study is to examine whether meditation delivered by the internet improves~     mood and attention as well as increases levels of dopamine in individuals who have been~     diagnosed with Multiple Sclerosis.~   "
89693|NCT02393118|"~     The BrainPort V200 Device is a wearable, non-surgical, prosthetic device intended for people~     who are profoundly blind. The BrainPort V200 translates images captured by a digital camera~     into electro-tactile stimulation presented on the user's tongue to perceive shape, size,~     location, and motion of objects within the environment. The purpose of this study is to~     evaluate the safety and functional performance of the BrainPort V200 device in individuals~     who have been medically documented as blind, light perception or worse, due to a traumatic~     injury (cortical or ocular).~   "
89694|NCT02393105|"~     This study explores the relationship between the sense of hope and fatigue in breast cancer~     survivors and provides a reference for future planning improvements for breast cancer~     survivors experiencing fatigue.~   "
89695|NCT02393092|"~     This study will evaluate the effectiveness of a hospital-community based violence prevention~     pilot study designed to increase protective factors and reduce negative risk factors~     associated with violence of children aged 10-15. Behaviors and attitudes that relate to~     violence and behavior change will be assessed through a series of questionnaires administered~     in an interview format. Assessments will occur every nine weeks. Additionally, objective long~     term measures for violence related hospital visits, delinquency, and educational development~     will be obtained.~      The study will include the following interventions:~        1. Brief violence prevention (BVP): a case manager administered psycho-educational~          intervention that will include an interactive discussion with youth regarding resources~          for remaining safe and preventing violence. The intervention will address the concerns~          and questions of youth and youth will be given information on how to access community~          based resources if needed.~        2. Brief violence awareness (BVA): a packet of information about violence prevention and~          local community resources.~        3. Emerging Leaders: East End: a semester (17 weeks) long curriculum based positive youth~          development education program held at the Boys and Girls Club of Metro Richmond, Martin~          Luther King Middle School site that includes case management to ensure continued~          engagement and participation.~      Specifically, it is hypothesized that:~        1. Participants will report more positive youth behaviors as compared to their initial~          assessment.~        2. Participants will report lower levels of risky youth behaviors compared to their initial~          assessment.~        3. Participants will report increased interest in and knowledge of health professions.~        4. Participants will report reduced levels of delinquency compared to their initial~          assessment.~        5. Participants will report a reduction in the number of violence related hospital visits~          compared to the general 23223 population.~        6. Hospital data will show a reduction in violence related activities that led to hospital~          visits, or delinquent behavioral involvement.~   "
89696|NCT02393079|"~     The purpose of this study is to evaluate the early and late effects of Transcranial Led~     Therapy (TLTC) in memory and executive functions in patients with moderate and severe TBI~     history in the initial phase (3-6 months).~   "
89697|NCT02393066|"~     This is a single-blind randomized clinical trial. Patients undergoing abdominal tumor surgery~     were recruited to participate in the study. Apart from routine treatment in the surgical~     intensive care unit, the subjects were randomly divided into two groups: Propofol group~     (Group P) and Dexmedetomidine group (Group D) and received continuous intravenous infusion of~     Propofol (infusion dosage range: 0.3 ~ 1.6 mg/kg/h) or Dexmedetomidine (infusion dosage~     range: 0.1 ~ 0.7 mcg/kg/h) according to their assigned group. Patients' hemodynamic status~     was monitored using a chest Bioreactance technique, Continuous Non-Invasive Cardiac Output~     and Hemodynamic Monitor at preset time points (time of recruitment [0h], 2, 4, 6, 12h and~     24h). Clinical data such as vital signs, hemodynamic parameters, laboratory results, fluid~     volume and drugs used were also recorded.~   "
89698|NCT02393053|"~     Background: This randomized controlled clinical study of split-mouth aimed to compare~     non-pedicled buccal fat pad graft (BFPG) with subepithelial connective tissue graft (SCTG) in~     the treatment of Miller Class I or II gingival recessions.~      Methods: Twelve patients with Miller Class I or II (≥ 2 mm) bilateral recessions in maxillary~     premolars or canines were selected. The recessions were randomly assigned to receive SCTG~     (Control Group) or BFPG (Test Group). The clinical parameters of Gingival Index (GI), Plaque~     Index (PI), Probing Depth (PD), Gingival Recession (GR), Clinical Attachment Level (CAL),~     Width of Keratinized Tissue (WKT), Thickness of Keratinized Tissue (TKT) and Gingival Margin~     to the Acrylic Guide (GM-AG) were evaluated at baseline, and in the postoperative periods of~     1, 3, and 6 months. The percentage of root coverage was also evaluated. Data were submitted~     to repeated measures ANOVA, Bonferroni method and t-test (p<0.05).~   "
89699|NCT02393040|"~     The purpose of this study is to determine the efficacy of treatment with Platelet-rich plasma~     on Androgenetic alopecia (compared with placebo), between six months and baseline.~   "
89700|NCT02393027|"~     Idiopathic Parkinson's disease (IPD) is a degenerative disease affecting the dopaminergic~     system. Clinical symptoms of IPD commonly begin after the loss of at least 40 to 50% of~     striatal dopaminergic terminals (specially putaminal terminals).~      The Dopamine neuronal transporter (DAT) is a highly expressed protein in the membrane of~     presynaptic nigrostriatal dopaminergic terminals. The use of a DAT's radioligand in the~     initial stages of the disease would lead to an early detection of nigral cell loss.~      Currently, only one DAT's radioligand has obtained marketing authorization in France, the~     123I-FPCIT, for use in Single Photon Emission Computed Tomography (SPECT).~      Otherwise, the Positron Emission Tomography (PET), a more sensitive technology than SPECT~     with higher resolution has become for a few years the new gold standard for visual analysis~     and quantification of neurotransmission systems (including the dopaminergic system).~      A DAT tracer labelled with Carbon 11 ([11C] PE2l) have been developed and is currently used~     as a reference in various research centers.~      However, in order to enable a clinical use of this tracer (which currently can't be because~     of the too short period of Carbon 11), the unit INSERM U930 Imaging and Brain in~     collaboration with the CERRP (Center for Studies and Research on Radiopharmaceuticals)~     developed a new version of this tracer, labelled with 18-fluor: the [18F] LBT-999.~      The main goal of this study is to compare the [18F] LBT-999 uptake between a group of~     patients suffering from a Parkinsonien syndrome to a group healthy volunteers.~   "
89701|NCT02393014|"~     This study aims to evaluate the feasibility and the impact on physical performance and falls~     occurence among geriatric inpatients hospitalized in acute care unit.~   "
89702|NCT02393001|"~     The purpose of this research study is to determine if a very sensitive chemistry lab analyzer~     can be used to smell a skin cancer (like melanoma) similar to some dogs.~   "
89712|NCT02392871|"~     The purpose of this study is to investigate the side effects and safety, and effectiveness of~     combining dabrafenib and trametinib with radiotherapy.~      Previous and ongoing clinical trials have demonstrated the effectiveness and safety of~     combining both dabrafenib and trametinib compared with dabrafenib alone. This has led to the~     approval for the use of both drugs in combination in people with metastatic melanoma with the~     BRAF mutation. Melanoma that has spread to other parts of the body may also benefit from~     radiotherapy to help reduce symptoms from melanoma. Previous studies have shown that melanoma~     may be sensitive to radiotherapy and that it can help to improve quality of life.~      The intention of the CombiRT study is to establish if dabrafenib, trametinib and radiotherapy~     combined is a safe and effective treatment for metastatic melanoma.~   "
89703|NCT02392988|"~     In recent years, it is accepted to induce birth at week 41 in order to reduce the risk in~     surplus pregnancies. It was found that after 41 weeks, there is a significant increase in~     pregnancy complications including meconium liquor, shoulder dystocia and fetal death in~     uterus.~      Induction at 41 weeks was found to reduce the risk of complications described above, without~     taking the risk of cesarean section and, therefore, the recommendation of the Israel Society~     of Maternal Fetal Medicine, is to induce birth for women who completed 41 weeks of pregnancy.~      Induction is performed mechanically by entering a balloon to the cervix or by medicated~     prostaglandins and later, intravenous Pitocin to most women. The process takes two to three~     days with about 60-70% success rate.~      In recent years there has been a growing awareness to use natural methods to start labor.~      Many women tend to turn to natural medicine in order to reduce the need for conventional~     drugs to start labor.~      Given the lack of research on the issue and considering the rising demand of the involvement~     of alternative medicine in labor induction process, the investigators decided to carry out~     research on this subject.~   "
89704|NCT02392975|"~     This proposal will test the diagnostic utility of fast magnetic resonance (MR) in young~     children with Traumatic brain Injury (TBI).~      In children, TBI causes >2000 deaths, 35,000 hospitalizations and 470,000 emergency~     department visits in the US each year, making it a leading cause of pediatric disability and~     death. Currently 20-50% of these children undergo computed tomography (CT) scanning, exposing~     them to harmful radiation, and increasing their lifetime risk of cancer. Risks are especially~     increased in children because the neurologic exam is less reliable, because growing tissues~     are more vulnerable to radiation, and because children have more years to accumulate harmful~     mutations.~      Fast MR is a short, motion-tolerant protocol that has been used in children with shunted~     hydrocephalus to eliminate radiation exposure without the need for sedation. However, fast MR~     has not been validated in children with TBI, a critical gap. The investigators will measure~     feasibility and diagnostic utility of fast MR in children < 6 years (72 months) old who~     undergo head CT for TBI.~      The Investigator will recruit children in whom a head CT is ordered for TBI. Consenting~     subjects will undergo fast MR shortly after CT and results will be compared to determine: 1)~     whether fast MR identifies all traumatic injuries identified by CT and 2) whether fast MR~     without sedation can be performed quickly and successfully.~   "
89705|NCT02392962|"~     All the athletes should perform a warm-up consisting of five minutes of jogging and static~     stretching (Experimental Group 1) or dynamic stretching (Experimental Group 2). Before the~     beginning of the study and right after performing the stretching protocol, the investigators~     evaluated the unipedal postural stability, the acustic reaction time, the joint position~     sense of the knee and the countermovement jump of the athletes.~   "
89706|NCT02392949|"~     Previous studies have shown that peripheral muscles weakness or inhibition is related to~     spinal disorders. Passive mobilization and manipulation are likely to reverse such muscle~     weakness for patients with spinal pain. The purpose of the study was to assess the effect of~     spinal mobilization on the maximal muscle strength of the shoulders.~   "
89707|NCT02392936|"~     There is a recent increase in incidence of surgical site infection after cardiac surgery in~     our hospital, in spite of specific measures taken concerning some aspects of the surgical~     procedures, targeting a better control of the classically known major risk factors of~     infections, in routine procedures involving a sternotomy such as coronary artery bypass~     graft, valvuloplasty, aortic surgery, or combined procedures.~      The first objective of this monocentric prospective cohort study, is to evaluate~     underestimated specific risk factors of surgical site infection, during the perioperative~     period, for patients undergoing cardiac surgery with sternotomy.~      Secondly, to estimate the specific risk associated with each class or micro-organisms~     responsible, and their profile of resistance.~      The outcomes concern the occurrence of a surgical site infection diagnosed by the surgeon in~     charge of the patient, one month and three months after surgery; it may concern the pre~     operative period, the procedure itself, or the early post operative period, characterized by~     a high density of cares, or even the late rehabilitation, after discharge of the surgical~     unit.~      Secondary outcome evaluate the profile of agents identified regarding the susceptibility of~     the prophylaxis recommended to prevent wound infection; it may suggest that an adequate~     antibiotic prophylaxis is often insufficient to take into account the responsible agents, and~     that decolonisation is not always that helpful, in view of emerging cases of failure due to~     developing resistance.~      Considering the low incidence of that type of complication, the investigators estimated that~     a period of two years might be necessary to include a sufficient number of patient, at least~     one thousand, in order to find a dozen of factors that might be significantly associated with~     an increased risk of surgical site infection.~      The evaluation is permitted by the collaboration between the anesthesiologists, surgeons,~     intensivists, hygienists, all along the presence of the patient in the department, until~     discharge out of the hospital and after readmission eventually for infectious complication.~   "
89708|NCT02392923|"~     Cohort descriptive study of quality of life and body functions in a reference population of~     Swedish inhabitants from age 30 to age 89. The population was selected to be representative~     for the general Swedish population and 500 in each 10 year group, 250 men and 250 women.~      The population is contacted and asked for informed consent, whereafter a questionnaire of~     about 200 questions, used in a number of studies in clinical studies and trials, are sent~     out.~      The results will be used as reference values to our patient cohorts~   "
89709|NCT02392910|"~     Iron deficiency, independent of anemia, appears to increase morbidity and mortality as well~     as impairing health-related quality of life in chronic heart failure (CHF), and these effects~     are compounded when patients also experience chronic kidney disease (CKD). This study was~     designed to determine the effects of intravenous iron treatment on morbidity and mortality~     following an initial 6-month period and a longer period of up to 5 years.~   "
89710|NCT02392897|"~     Eating frequency may play an independent role in appetite regulation, overall caloric~     consumption and measures of long-term health or disease risk. Some literature recommends~     frequent eating, but pilot data suggest that this type of eating pattern may be harmful to~     health since it leaves the body in a perpetual fed state and increases systemic inflammation.~     Therefore, the investigators will conduct a clinical trial in 50 healthy adults to compare a~     low frequency eating pattern to a high frequency eating pattern in relation to blood-based~     markers of inflammation, metabolic health and appetite. Study results will be applied to~     recommendations for eating frequency in the context of an overall healthy diet.~   "
89711|NCT02392884|"~     The purpose of this study is to determine whether cognitive rehabilitation or psychoeducation~     impacts medication adherence in HIV-1 seropositive individuals.~   "
89713|NCT02392858|"~     Influenza is a major cause of morbidity and mortality. The investigators first goal is to~     evaluate soluble HLA-G5 isoform serum level as a potential marker of greater risk of death~     from Influenza respiratory illness in adult and pediatric patients hospitalized in~     reanimation. Secondly, the investigators collected respiratory samples in order to study the~     transcriptomic profiles of influenza-infected patients with severe symptoms.~   "
89714|NCT02392845|"~     To determine the maximum tolerated dose of a densified regimen of the association of~     docetaxel (DTX) and epirubicin (EPI), supported by the concomitant administration of~     hematopoietic growth factors in patients with metastatic breast cancer in first-line,~     optimizing in each patient the administration schedule using a formal procedure based on~     mathematical models in order to manage the severity of induced neutropenia.~      The models used in this project allow:~        -  an optimal administration schedule of the planned total dose per cycle (number of~          infusions and calculating their rates and durations)~        -  an individualization of the administration schedule from the second cycle (based on~          observations from the first cycle), and~        -  an assessment of the risk of a dose-limiting toxicity event combining several severe~          non-hematological toxicities (conditioning the decision for dose escalation).~      Using formal mathematical models the investigators expect controlling the hematological and~     non-hematological toxicities in order to realize the full series of six cycles of densified~     DTX+EPI chemotherapy (2 weeks per cycle) for each patient. For each patient, chemotherapy is~     considered feasible if it is possible, in the absence of tumor progression, to consider 6~     cycles of treatment without observing any serious adverse events and without:~        -  patient death that may be related to the treatments;~        -  decision of the patient to interrupt treatment for physical or psychological tolerance~          reasons;~        -  decision of the investigator to discontinue treatment, in the absence of disease~          progression.~   "
89715|NCT02392832|"~     In the past decade, massive scale-up of insecticide-treated nets (ITN) and indoor residual~     spraying (IRS), together with the introduction of artemisinin-combination treatments, have~     led to substantial reductions in malaria prevalence and incidence in African highlands.~     However, rising insecticide resistance and increased outdoor transmission have greatly~     hampered the effectiveness of ITN and IRS because the current indoor-based interventions do~     not target the outdoor-biting mosquitoes. Therefore, new supplemental interventions that can~     tackle outdoor transmission and pyrethroid insecticide resistance are urgently needed. The~     central objective of this study is to determine the efficacy and cost-effectiveness of~     EPA-approved long-lasting microbial larvicides in reducing malaria transmission and clinical~     malaria incidence in western Kenya highlands.~   "
89716|NCT02392819|"~     This project evaluate effects of a commonly used food supplement on glucose metabolism and~     cognitive function.~   "
89717|NCT02392806|"~     Multiple different devices are available to provide Bubble CPAP to preterm and newborn~     infants. The most significant difference between these devices is the size of the bubble~     produced by the exhalation limb. This study will determine if one Bubble CPAP device~     (BabiPlus vs B&B) is more effective in improving oxygenation and decreasing extubation~     failure in the extremely low birthweight population.~   "
89718|NCT02392793|"~     The drug, talazoparib, seems to work against cancer in test tubes and animals by preventing~     DNA repair in damaged cells leading to their death. Investigators do not know if talazoparib~     combined with irinotecan will work in humans. Talazoparib has been used in only a small~     number of adults and children, and there is much not yet known about it.~      In Arm A of this study, investigators seek to find the safest dose of irinotecan to give with~     talazoparib to children and young adults. In a phase I study, different dose levels of drug~     may be tested. The first 2 or 3 patients will be given a dose, and if none of them has a bad~     side-effect, the next 2 or 3 patients will be given a higher dose. No temozolomide will be~     given in in Arm A.~      The experimental drug combination of talazoparib and irinotecan will be tested in the hopes~     of finding a treatment that may be effective against recurrent or refractory solid tumors.~     The goals of study Arm A are:~        -  To determine whether the combination of talazoparib and irinotecan is a beneficial~          treatment for your cancer;~        -  To learn what kind of side effects talazoparib can cause;~        -  To learn what kind of side effects talazoparib in combination with irinotecan can cause;~        -  To learn more about the biology of talazoparib in children diagnosed with solid tumors.~      The purpose of Arm B is to to find the safest doses of irinotecan and temozolomide to give~     with talazoparib to children and young adults with a solid malignancy.. Talazoparib belongs~     to a family of drugs called poly ADP ribose polymerase or PARP inhibitors. Irinotecan and~     temozolomide belong to a family of drugs called DNA damaging agents.~      There are two arms of this trial, A and B. In this study, investigators hope that irinotecan~     (administered in Arm A) and irinotecan plus temozolomide (administered in Arm B) will damage~     the DNA of the cancer cells. Then, talazoparib (which is a PARP inhibitor) will block the~     repair of the cancer cell's damaged DNA, causing the cancer cell to die (a process called~     apoptosis).~      There are different types of cancers found in children and young adults which appear to be~     vulnerable to the combination of chemotherapy agents that will be given in this study. Work~     carried out in the lab show that these agents may be very promising in the treatment of ewing~     sarcoma, germ cell tumors, wilms tumor, medulloblastoma and possibly neuroblastoma.~   "
89719|NCT02392780|"~     Graft-versus-host-disease (GVHD) is a major obstacle to successful allogeneic hematopoietic~     cell transplantation (alloHCT). Cannabidiol (CBD), a non-psychotropic ingredient of Cannabis~     sativa possesses potent anti-inflammatory and immunosuppressive properties. In a recent phase~     2 study, CBD has been shown to be safe and reduced significantly the incidence of acute GVHD~     compared to control patients with a hazard ratio of 0.3. Based on these results the~     investigators propose a phase 2 study to explore the efficacy of oral CBD in the treatment of~     severe (grades III/IV) acute GVHD, a pathology with a dismal prognosis.~   "
89720|NCT02392767|"~     The effect of a combination product (Verum ) with L-arginine, Pycnogenol, vitamin K2,~     R-(+)-alpha-lipoic acid and vitamins B6, B12 and folic acid is investigated in a double blind~     placebo-controlled cross-over study. Volunteers with hypertension and hyperhomocysteinemia~     are randomly assigned to the dietary supplement or placebo.~   "
89721|NCT02392754|"~     Atrial fibrillation (AF) is a major treatable risk factor for stroke, but it may be hard to~     detect because it is frequently silent and intermittent. New ambulatory cardiac monitoring~     technologies have the potential to improve early detection of AF. This trial investigates AF~     screening in primary care patients using the ZIO XT Patch, a wearable adhesive patch monitor~     that provides continuous ECG recording for up to 14 days, in addition to the WatchBP home~     blood pressure monitor that has built-in AF screening capability.~   "
89722|NCT02392741|"~     This study aims to determine the effect of a physical exercise program on microcirculation~     and maternal and perinatal outcomes in obese women. A randomized clinical trial will be~     performed at IMIP with obese pregnant women assisted at the Instituto de Medicina Integral~     Professor Fernando Figueira (IMIP) prenatal service.~   "
89735|NCT02392572|"~     The goal of Phase I of this clinical research study is to find the highest tolerable dose of~     ONC201 alone or in combination with low dose cytarabine (LDAC) that can be given to patients~     with relapsed or refractory AML, ALL, or MDS. The goal of Phase II of this study is to learn~     if the dose of ONC201 given alone or in combination with LDAC that is found in Phase I can~     help to control the disease.~      The safety of the study drug will be studied in both phases of this study. This is the first~     study using ONC201 in humans.~      ONC201 given alone or in combination with LDAC is in a very early stage of development for~     use in humans. Providing direct medical benefit to you is not the purpose of this study.~     While Phase II will look at the effectiveness of the study drug given alone or in combination~     with LDAC, the main purpose of this study is to learn about the safety of the drug.~   "
89723|NCT02392728|"~     The mood disturbances that lung cancer patients experience during and after chemotherapy have~     a debilitating effect on their quality of life. The goal of the proposed project is to~     develop and test an intervention that relies on the use of immersive Virtual Reality (VR) to~     combat the adverse psychological/emotional consequences of receiving treatment for cancer.~     Although VR has been used with success to treat various psychological conditions (e.g.,~     phobias, PTSD), its potential in helping cancer patients experience an improved mood and~     hence better quality of life has not yet been tested. In this project the investigators will~     first develop the virtual content (e.g., natural scenes) that patients will experience within~     a Head-Mounted-Display, simulating movement by manipulating a gesture controller. The~     investigators will then carry out a randomized, double blind, crossover trial with 50~     hospitalized cancer patients to test whether they can benefit psychologically and emotionally~     from their interaction with an immersive environment compared to those who will experience a~     guided imagery intervention. A positive result will open the route for the future development~     of affordable self-administered VR solutions for treating the psychological side-effects of~     cancer treatment.~   "
89724|NCT02392715|"~     Chronic Obstructive Pulmonary Disease (COPD) is a frequent disease, with increasing~     prevalence. Pulmonary rehabilitation through general exercise training (GET) is a corner~     stone of COPD care. Inspiratory muscle training (IMT) as a stand-alone therapy decreases~     dyspnea and improves exercise capacity. Whether IMT combined with GET adds a supplementary~     benefit in the rehabilitation of COPD patients is however uncertain.~   "
89725|NCT02392702|"~     This two-part study will assess, in healthy volunteers, under both fasted and fed conditions,~     and in a sequential manner, the safety, tolerability and pharmacokinetics (PK) profile of~     single doses of C-10355 and C-10358 and single ascending doses of the selected compound~     compared to a single dose of Kalydeco®.~   "
89726|NCT02392689|"~     Patients presenting to the Emergency Department with shortness of breath and (suspected)~     heart failure will be screened and randomized to either a standard of care or a~     procalcitonin-guided arm.~      Procalcitonin-guided arm: a procalcitonin level (cutoff 0.2 ng/ml) will be used to support~     decision on antibiotic therapy initiation.~      Standard of care arm: the decision on antibiotic therapy will be based on the physicians~     intent to treat.~      The patients will be followed up 30 and 90 days after randomization to evaluate the survival~     status, re-hospitalizations and further antibiotic therapies.~   "
89727|NCT02392676|"~     Olaparib administered as monotherapy in the maintenance setting improves progression free~     survival compared to placebo in patients whose tumours carry loss of function (deleterious or~     suspected deleterious) somatic BRCA mutations or loss of function (deleterious or suspected~     deleterious) mutation in non-BRCA Homologous Recombination Repair (HRR) -associated genes who~     have a complete or partial response to platinum-based chemotherapy.~   "
89728|NCT02392663|"~     This study aims to analyze whether the hypertonic saline nebulization enhances sputum~     clearance effects, reduces the impact on cough severity and their level of safety and~     tolerability in a population with non-cystic fibrosis bronchiectasis (NCFBE). In addition,~     this trial aims to compare these health outcomes among 3 nebulized solutions: hypertonic~     saline (7%); hyaluronic acid + hypertonic saline (7%); isotonic saline (0,9%).~   "
89729|NCT02392650|"~     Hominids and hominins serve as remarkable hosts to microbes, and we have co-evolved over the~     past 4.5 million years as highly plethoric communities. Human-associated microorganisms (the~     microbiome) are present in numbers exceeding the quantities of human cells by at least~     10-fold beginning in the neonatal period. The collective genome (the metagenome) exceeds~     our human genome in terms of gene content by more than 150-fold. With respect to microbiota~     and preterm birth, it has generally assumed that the majority of intrauterine infections~     originate in the lower genital tract, with microbiota ascending into the otherwise sterile~     intrauterine environment to infect the placenta (preterm birth), fetal membranes~     (chorioamnionitis), umbilical cord (funisitis), and the fetus (sepsis). However, we and~     others have recently demonstrated that the vaginal and gut microbiome communities are~     distinctly structured in pregnancy, and the placenta is in fact not sterile, but rather~     harbors a low-abundance microbiome which is likely acquired through hematogenous transmission~     of the oral microbiome.~      Based on our prior studies and preliminary data, our central hypothesis is that a distinct~     and largely commensal resident microbiome in pregnancy renders risk for preterm birth. By~     utilizing our state-of-the-science technology and analysis tools in a longitudinal~     case-cohort of preterm birth subjects, we will be able to transform discovery based~     metagenomics and multi'omics science into readily translatable mechanistic studies at a~     previously unparalleled level.~   "
89730|NCT02392637|"~     The goal of this clinical research study is to learn if adding abraxane (nab-paclitaxel) to~     gemcitabine and cisplatin can help to control metastatic (has spread) or unresectable (cannot~     be removed by surgery) biliary cancer. The safety of this drug combination will also be~     studied.~   "
89731|NCT02392624|"~     This multicenter, randomized, double-blind, placebo-controlled study will evaluate the~     efficacy and safety of subcutaneous (SC) omalizumab (Xolair) as an add-on therapy through 48~     weeks for treatment of H1 antihistamine refractory chronic idiopathic urticaria (CIU). After~     completing an initial 24-week open-label treatment period with omalizumab 300 milligrams (mg)~     every 4 weeks (Q4W), participants responding to omalizumab will be randomized at a 3:2 ratio~     (omalizumab:placebo) to either continue omalizumab or be transitioned to placebo for a~     further 24 weeks.~   "
89732|NCT02392611|"~     This study will evaluate the safety, tolerability, pharmacokinetics (PK), and~     pharmacodynamics (PD) of GS-5829 in adults with advanced solid tumors and lymphomas and in~     combination with exemestane or fulvestrant in adults with estrogen receptor positive breast~     cancer.~   "
89733|NCT02392598|"~     This is an epidemiologic study on effect of hepatic steatosis on prognosis and outcomes of~     patients with chronic hepatitis B.~   "
89734|NCT02392585|"~     The aim of study is to compare triple tourniquet vs. single tourniquet to reduce blood loss~     at open myomectomy.~   "
89736|NCT02392559|"~     A study to assess safety and efficacy of evolocumab (AMG-145) in paediatric subjects aged~     10-17 years diagnosed with heterozygous familial hypercholesterolemia.~   "
89737|NCT02392546|"~     This is a randomized trial of 36 otherwise healthy patients with chronic idiopathic~     constipation. The purpose of the study is to compare the effects of daily single-dose oral~     elobixibat and placebo for 7 days on colonic motor effects.~   "
89738|NCT02392533|"~     Ultrasonography is routinely performed during pregnancy by obstetricians to visualize the~     fetus, making patients familiar and comfortable with its usage. Ultrasonography does not~     result in adverse effects to the mother or fetus and is readily available at most facilities,~     yet is not routinely used to identify lumbar interspaces prior to providing neuraxial~     anesthesia. Ultrasonography is a valuable tool for accurately identifying lumbar~     intervertebral spaces and is more accurate than simple palpation of obscure anatomic~     landmarks. The investigators are interested to know the accuracy of anatomic landmark~     palpation in predicting the lumbar interspace of neuraxial anesthesia administration compared~     to identification of the interspace by ultrasound. The investigators are also interested in~     presenting anesthesia providers with feedback regarding their accuracy and then investigating~     whether this feedback causes a change in provider practice (i.e. use of ultrasound) or~     improved identification of the interspace prior to providing neuraxial anesthesia.~   "
89739|NCT02392520|"~     The study aims to compare the novel method of GnRH antagonist administration in the luteal~     phase versus conventional treatment in IVF patients who develop severe early ovarian~     hyperstimulation syndrome and have all their embryos cryopreserved.~   "
89740|NCT02392507|"~     The purpose of the study is to determine if nab-paclitaxel and carboplatin chemotherapy plus~     necitumumab is effective and safe in participants with stage IV squamous non-small cell lung~     cancer.~   "
89741|NCT02392494|"~     The purpose of this study is to evaluate the safety and pharmacokinetics of MK-1075, and to~     determine the ability of MK-1075 to reduce HCV viral load, following administration of a~     single dose in HCV-infected participants.~   "
89742|NCT02392481|"~     The main objective of the trial is to explore if any of the biomarkers assessed are~     sensitively linked to the asthma phenotypes. This would potentially alone or in addition to~     other clinical or biofluid markers indicate if and how asthma endotypes are linked to~     phenotype such as eosinophilic, neutrophilic, or paucigranulocytic phenotypes. Further~     exploratory markers will be analysed for better understanding of physiological levels of~     proteins and markers playing a role in regard to disease characterization in asthma. As a~     basis for further development of a biomarker for asthma, The sponsor plans to conduct this~     exploratory biomarker trial to determine levels and reference ranges of biomarkers~     potentially associated with asthma phenotypes. The trial aims at generating a panel of serum~     biomarkers that can be evaluated in subsequent interventional studies. The longitudinal~     design will be used to ascertain stability and test-retest reliability.~   "
89743|NCT02392468|"~     Single site, parallel-group, double-blind trial of low or high dose of BI 409306 to evaluate~     the ocular and systemic safety and pharmacokinetics during 14 day treatment period in~     patients with schizophrenia, Alzheimer's disease, or age comparable healthy volunteers.~   "
89744|NCT02392455|"~     This observational study will investigate the efficacy and tolerability of Vargatef~     (Nintedanib) plus docetaxel in daily routine second-line treatment in patients with locally~     advanced, metastatic or locally recurrent NSCLC. Treatment with Vargatef in eligible NSCLC~     patients, for whom the treating physician has decided to initiate treatment with Vargatef in~     second line according to the local label, will be observed for up to 24 months. Survial~     follow-up will be done until the end of the study.~   "
89745|NCT02392442|"~     Background:~      - When bacteria enter the lungs, serious infections can occur. Researchers want to learn more~     about the process of inflammation in the lungs by studying lung cells and the products that~     they make. Lung cells are influenced by infections, smoking, and molecules made within the~     body. Researchers also want to learn more about one of these molecules, called microRNA (or~     micro ribonucleic acid).~      Objective:~      - To better how the body responds to infection. Also, to understand which cells in the lung~     secrete microRNA and how they may influence other lung cells.~      Eligibility:~      - Healthy, non-smoking adults ages 18-45.~      Design:~        -  Participants will be screened with a medical history and physical exam. They will have~          blood and urine tests and an electrocardiogram.~        -  Participants will have blood drawn from an arm vein. They will have an intravenous~          catheter (small plastic tube) placed in a vein.~        -  All participants will have bronchoscopy with bronchoalveolar lavage. They will be numbed~          with medicine. A thin flexible tube will be placed through the nasal passages or the~          mouth into the airways of the lung.~             -  Some participants will have bronchoscopy with bronchoalveolar lavage (rinsing the~               airways with salt water) in order to obtain cells from lung. The water will then be~               suctioned out.~             -  Some participants will have two bronchoscopies; during the first procedure,~               endotoxin, a molecule found in bacteria is squirted into a small portion of the~               lung. Endotoxin is a molecule that acts like an infection but isn t one. After 6 to~               48 hours, bronchoscopy with with bronchoalveolar lavage will be done to look at the~               lung s response to endotoxin.~        -  Participants heart rhythm and rate, temperature and blood oxygen level will be monitored~          during the procedures.~        -  Participants will be called the next day to see how they are feeling.~   "
89746|NCT02392429|"~     This phase II trial studies fluorothymidine F 18 (FLT) positron emission tomography~     (PET)/computed tomography (CT) in measuring response in patients with previously untreated~     acute myeloid leukemia. FLT is a radioactive substance that may light up where cancer is in~     the body. FLT is injected into the blood and builds up in cells that are dividing, including~     cancer cells. Diagnostic procedures, such as PET/CT, may help measure a patient's response to~     earlier treatment.~   "
89747|NCT02392416|"~     Treatment of hypercholesterolemia is based on the guidelines of ESC-EAS 2011 (European Heart~     Journal (2011) 32, 1769-1818, ESC / EAS Guidelines for the management of dyslipidaemias)~     These calculate the 10 year risk based on SCORE tables - Systematic COronary Risk Estimation~     and taking into account specific parameters in the patient's profile.~   "
89748|NCT02392403|"~     The aim of this study is to investigate the clinical benefit for patients implanted with the~     Nucleus® CI532 cochlear implant and to demonstrate the atraumatic nature of the electrode~     design.~      Nucleus® CI532 has a pre-curved, perimodiolar array, the EA32, which is introduced into the~     cochlea through a straightening sheath.~   "
89749|NCT02392390|"~     The main objective of this study is to estimate the change in the relative numbers of~     commensal or low virulence potential bacteria before and after one session TDP.~   "
89750|NCT02392377|"~     This randomized pilot phase II trial studies how well molecular phenotyping works in~     predicting response in patients with stage IB-III esophageal cancer who are receiving~     carboplatin and paclitaxel or oxaliplatin, leucovorin calcium, and fluorouracil. Studying the~     genes in a patients tumor cells before and after chemotherapy may help in understanding if~     there are specific features of the tumor cells that make a person more or less likely to~     respond to treatment and how these features may be affected by treatment.~   "
89751|NCT02392364|"~     The purpose of this study is to compare the safety and efficacy of intravitreal Eylea~     injections at a set interval, versus a variable dosing schedule (likely longer than one~     month), based on a specific individual's disease progression. There will be approximately 50~     men and women at least 18 years of age, diagnosed with type 1 or type 2 diabetes, taking part~     in this study at 5 locations in the United States.~   "
89753|NCT02392338|"~     In this study, the investigators therefore comparatively analyzed the mid-term results (at 1~     year) including electrocardiogram, 24 hour Holter monitoring, and 2 week long-term~     electrocardiogram of thoracoscopic ablation and RFCA performed individually or as a hybrid~     procedure in patients with long-lasting persistent atrial fibrillation. Antiarrhythmic~     medication, discontinuation of anticoagulation medication, and echocardiographic findings~     were also analyzed.~   "
89754|NCT02392325|"~     Dengue viruses infect millions of people throughout the tropics and subtropics each year. The~     development of a dengue vaccine is an important health priority. This study will evaluate the~     immunologic and clinical response to two dengue vaccines, given 9 months apart, in healthy~     adults with no history of previous flavivirus infection.~   "
89755|NCT02392312|"~     A multicenter, prospective, observational study to evaluate the safety and efficacy of~     individual batches of ATG-F in kidney transplant recipients.~   "
89756|NCT02392299|"~     The purpose of this study is to explore the relative importance of the frailty and~     cardiovascular function as potential exercise-modifiable risk factors for falling in patients~     receiving haemodialysis.~   "
89757|NCT02392286|"~     Prospective randomized comparative effectiveness trial designed to compare fixed dosing and~     weight-based dosing of corticosteroids in patients with Crohn's disease flares.~   "
89758|NCT02392273|"~     This study is an observational study with the primary objective to assess the safety and~     tolerability of Ausanil in the treatment of primary headache disorders. The secondary~     objective is to assess headache pain, functional outcome, time loss to headache and patient~     satisfaction with Ausanil treatment.~   "
89759|NCT02392260|"~     This project is part of the EU funded project NISTAS. NISTAS aims at the development of a new~     medical device for non-contact, non-invasive screening of the health status of the vascular~     system of adult subjects. The instrument, called VascuLight, is intended to be deployed at~     out-patient points-of-care and hospitals, and it provides output parameters related to the~     PWV as measured at local and/or at regional level.~      NISTAS brings together four European SMEs in four different, but complementary, technology~     areas (JULIGHT, ECLEXYS, EPI-LIGHT, OIP) and links them with five RTD Performers (UNIPV, OSM,~     CORK UNIVERSITY, Saphyrion, Eudax srl ) to develop new knowledge and a new medical device~     which will have significant commercial benefits for all of the SME partners.~      VascuLight responds to an unmet need in the medical diagnosis practice: the request for a~     fast and sustainable method for the screening of the health of the vascular system in large~     series, capable of providing a reliable indicator of the cardiovascular risk of the screened~     subjects.~      The VascuLight idea is founded on a paradigm shift: bringing and adapting to the biomedical~     field measurement techniques that are to date confined to the industrial environment. NISTAS~     will develop new non-contact distance/displacement/vibration sensors based on a variant of~     the well-known and reliable laser triangulation technique.~      JUL and UNIPV have carried out proof-of-concept, in-vivo tests of the VascuLight approach to~     demonstrate that the concept is realistic and attainable. Results have been obtained using~     Laser Doppler Vibrometry (LDV), a displacement-measuring technique based on the principle of~     light interference, and an area where both JUL and UNIPV have made important contributions.~     In the tests it was possible to use TWO small LDV optical heads to simultaneously measure the~     pulse wave in two points on the carotid spaced by 2.5 cm, allowing for the calculation of the~     time-delay between the pulse waves, and thus providing a direct local measurement of the PWV.~      The aim of the study is to test the implemented contactless optical technique for the~     measurement of the PWV and the arterial stiffness at the carotid artery level.~      To evaluate the validity of the measure method, the investigators will compare Vasculight~     v1.0 PWV measures with those obtained from e-tracking (echocardiographic method) . The main~     idea is to compare the distribution of measures (comparable mean and standard deviation) in~     the same mixed adult population, using the two different methods.~   "
89760|NCT02392247|"~     This study compares the results of current standard coagulation measurement devices to the~     Quantra System, a new device, using small amount of extra blood obtained during routine blood~     draws in cardiac surgery patients.~   "
89761|NCT02392234|"~     The purpose of this study is to evaluate the efficacy of VX-661 in combination with ivacaftor~     and ivacaftor monotherapy in subjects with Cystic Fibrosis (CF).~   "
89762|NCT02392221|"~     Crohn's disease (CD) and ulcerative colitis (UC) are chronic Inflammatory Bowel Disease (IBD)~     and may affect all segments of the digestive tract. These are diseases of multifactorial~     origin in which environmental and genetic factors are predominant.The EPIMAD registry, the~     world's largest epidemiological register for IBD, identifying all incident cases in the four~     departments of the North West of France showed between 1988 and 2007, an increase in the~     annual incidence of MC 71 % (6.5 / 105 (1988-1990) 11.1 / 105 (2006-2007) p <0.0001) in the~     age group 10-19 years. At the same time, the annual incidence of UC decreased 4.3 / 3.5 105~     inhabitants / 105 inhabitants (20%), with phenotypic presentation remained stable. The~     increase in the incidence of CD will contribute to increase its weight in the health system,~     particularly in the pediatric CD frequently associated with an aggressive phenotype causing~     specific complications such as malnutrition, pubertal delay or thrive. These complications~     have a important impact on the quality of life with a long-term risk of functional~     disability. They may be associated with increased mortality. Immunosuppressants~     (azathioprine, methotrexate) have been used in pediatric forms only from the 90s and anti-TNF~     antibodies (infliximab and adalimumab), until the 2000s. These new therapeutic classes have~     profoundly changed the management of pediatric IBD. Although there is little data on the~     impact of these new treatments, early introduction of immunosuppressive and anti-TNFs seems~     to influence the natural history of IBD diagnosed in pediatric age. Anti-TNFs appear to be~     associated with more frequent and deeper remission. With the advent of these new treatment,~     new therapeutic targets such as endoscopic mucosal healing and more recently the deep~     remission combining clinical remission, biological and endoscopic, appears. However there is~     no data in the general population assessing the impact of new treatments and new therapeutic~     strategies in the pediatric population. Potential risks associated with the increasing use~     and early use of biological treatments in this particular population remain to be determined~     in the general population.~      The main hypothesis of this study is that changes in therapeutic strategies in IBD diagnosed~     before 17 yeras old could influence the cumulative incidence of surgical resection and~     complications specific to this population as failure to thrive and delayed puberty, insertion~     socio-professional, the extension of the disease, hospitalization rates, and the rate of~     cancer.~   "
89763|NCT02392208|"~     Chronic Kidney Disease Stage 5 (CKD5) patients receiving maintenance hemodialysis are at an~     increased risk for developing bloodstream infections. Vancomycin is traditionally used as~     first-line therapy for treating these infections, but the emergence of less-susceptible~     bacterial strains necessitates the consideration of alternative antibiotic therapy.~     Telavancin is a new antibiotic that has broad-spectrum antimicrobial activity against~     gram-positive bacteria, including vancomycin-intermediate staphylococcus aureus. While dosing~     recommendations for telavancin are available for patients with normal kidney function, there~     are no published recommendations for CKD5 patients receiving hemodialysis. A pharmacokinetic~     study is needed to characterize the pharmacokinetic parameters of telavancin in these~     patients to determine the extent of drug removal by hemodialysis and to establish dosing~     recommendations for CKD5 patients on maintenance hemodialysis.~   "
89764|NCT02392195|"~     This study will enable investigators to find out if brain structure and characteristics are~     affected by the shape of the infant's head, and if changes in the brain occur with helmet~     therapy.~   "
89885|NCT02390609|"~     The purpose of this study is to assess the relative bioavailability (the extent to which a~     drug or other substance becomes available to the body) of ibrutinib in healthy adults~     following single oral dose administration of suspension and sprinkle formulations under fed~     and fasted conditions compared with capsules under fasted conditions.~   "
89765|NCT02392182|"~     In its original phase, this cohort study recruited subjects who were either HIV-positive or~     HIV-negative healthy controls, to analyze the community structure of the lung microbiome.~     Original recruitment was planned to occur both at the University of Michigan Medical Center~     and clinics, and at VA Ann Arbor Healthcare System.~      Enrollment for the original cohort is completed, and all current activity of this project is~     occurring at VA Ann Arbor, where both Veteran subjects and non-Veteran subjects are eligible~     to participate. This study is currently recruiting only healthy HIV-negative subjects.~     Participation, described below, involves a research bronchoscopy procedure.~   "
89766|NCT02392169|"~     Attention-deficit/hyperactivity disorder (ADHD) is one of the most common child and~     adolescent psychiatric disorders. In recent years, some researchers have become interested in~     analyzing neuroendocrine substrate levels in ADHD, including dehydroepiandrosterone (DHEA),~     dehydroepiandrosterone sulfate (DHEA-S), cortisol and testosterone. Previous work in ADHD has~     established a strong heritable component to the phenotype. The STS gene, SULT2A1 gene and TH~     gene are associated with the function of DHEA/DHEA-S, and the NR3C1 gene is associated with~     the regulation of cortisol. Therefore, the relationship between these genes and the etiology~     of ADHD warrants investigation. Moreover, compared to the phenotype, the endophenotypes of~     ADHD may be more capable of detecting the underlying neurobiological and hereditary~     mechanisms. Therefore, this study aims to investigate the relationships between~     neuroendocrine substrates (DHEA, DHEA-S, cortisol and testosterone), candidate genes (STS~     gene, SULT2A1 gene, TH gene and NR3C1 gene) and the phenotype and endophenotypes (disease~     subtypes, neurocognitive function and response to treatment) of ADHD.~      To complete this work, we will recruit 300 patients with ADHD (probands) and 600 biological~     parents of the probands. DNA will be extracted from buccal cells by cheek swab. At baseline,~     saliva samples of ADHD patients will be collected between 7:00 and 8:00 am using the passive~     drool method, to analyze the levels of neuroendocrine substrates. The patients will undergo~     assessment for their clinical symptoms and neurocognitive function. Methylphenidate will then~     be administered to the patients and the usual practice followed. At week 4 and week 52,~     procedures similar to those performed at baseline will be repeated.~      The results of this study may further elucidate the complexity of the pathophysiology of~     ADHD. We may determine whether the neuroendocrine system, which contains levels of~     neuroendocrine substrates and associated genes, plays a crucial role in the phenotype and~     endophenotypes of ADHD. The information may serve as an important reference for the direction~     of future study and clinical treatment for patients with ADHD.~   "
89767|NCT02392156|"~     The primary objective of the study is to evaluate the effectiveness of prophylactic treatment~     with recombinant Factor VIII Fc fusion protein (rFVIIIFc) and recombinant Factor IX Fc fusion~     protein (rFIXFc) therapy as assessed by patient treatment burden and health economic outcomes~     while maintaining disease control in males with hemophilia A or B.~   "
89768|NCT02392143|"~     The purpose of this study (Healthy Colon Project II) is to evaluate different educational~     approaches for increasing rates of colorectal cancer (CRC) screening in a hard-to-reach urban~     minority population with health insurance.~   "
89769|NCT02392130|"~     The purpose of this study is to assess the effect of LEO 130852A gel 1% in maintaining skin~     thickness in healthy skin treated with steroid.~   "
89770|NCT02392117|"~     This study is conducted in Europe. The aim of this non-interventional study is to investigate~     the safety and effectiveness of insulin degludec (Tresiba®) in a real world population with~     type 1 (T1DM) and 2 (T2DM) diabetes mellitus.~   "
89771|NCT02392104|"~     The purpose of this study is to determine the feasibility, safety, and acceptability of~     implementing an extended interval of INR follow-up in Veterans on a stable dose of warfarin~     in the Anticoagulation Clinic at the William S. Middleton Memorial Veterans Hospital.~      All participants will be provided usual care from the anticoagulation clinic, except for the~     interval between INRs. If the participant continues to be on a stable dose of warfarin and~     the INRs are within the goal range of 2-3 (including lab variation), follow-up visits will be~     scheduled following an extended interval protocol. Patient satisfaction will be evaluated at~     various points throughout the study. Additionally provider satisfaction, confidence, and~     knowledge of the extended interval protocol will be analyzed. Bleeding and thromboembolic~     events will be evaluated to ensure the safety of an extended follow-up interval.~   "
89772|NCT02392091|"~     The aim of this study was to investigate the prevalence, type, and possible risk factors of~     RTA in critically ill patients using a physical-chemical approach.~   "
89773|NCT02392078|"~     The NeuroBlate® System (NBS) is a minimally invasive robotic laser thermotherapy tool that is~     being manufactured by Monteris Medical. Since it received FDA clearance in May 2009, the NBS~     has been used in over 1300 procedures conducted at approximately 56 leading institutions~     across United States. This is a prospective, multi-center registry that will include data~     collection up to 12 months to evaluate procedural success, local control failure rate, and~     QoL in up to 1,000 patients and up to 50 sites. Currently, the study has 162 subjects~     enrolled from 14 active sites~   "
89774|NCT02392065|"~     To estimate prevalence of chronic obstructive pulmonary disease (COPD) in cardiac surgery~     population and establish links between COPD status, as assessed through pulmonary functional~     tests, and 2-year mortality~   "
89775|NCT02392052|"~     Spinal cord injury (SCI) may result in physical deficits that require assistance from others~     in order to stay healthy and live independently in a community. The assistance provided by~     caregivers to a family member with SCI often involves a wide range of activities from helping~     with basic activities, like toileting and bathing, to managing more complex tasks, such as~     keeping up with household finances, shopping, and transportation. Caregiving puts demands on~     an individual's ability to cope and deal with day-to-day stresses, and may be influenced by~     personal beliefs about one's ability to cope with stress. Beliefs about our ability to~     perform tasks that affect our lives have been termed self-efficacy. A strong sense of~     self-efficacy has been shown to positively impact life choices, motivation, quality of~     functioning, resilience to adversity, and vulnerability to stress and depression. People with~     low self-efficacy tend to avoid challenges, discontinue tasks that are difficult, and be at~     risk for more depression and stress, resulting in less satisfaction with life.~      This study uses a psychological strategy, called cognitive behavioral therapy (CBT), to~     enhance self-efficacy skills for caregivers of family members with SCI, with a focus on~     changing thinking styles to help people make emotional and behavioral changes. The~     investigators hypothesize that by providing family caregivers with a six week group~     educational intervention, their self-efficacy skills as well as general life satisfaction can~     be improved, and minimize depression, stress and anxiety that often accompany the caregiving~     role. The innovation of the proposed intervention is its integration of positive~     psychotherapy concepts into structured group CBT to develop optimistic self-efficacy beliefs,~     strengthen the caregiver's ability to deal with day-to-day stress, and enhance a sense of~     well-being in the caregiver which, in turn, may benefit the family member with SCI.~   "
89776|NCT02392039|"~     The goal of this clinical research study is to learn if loratadine can control bone pain~     caused by pegfilgrastim (a drug given after chemotherapy to help raise white blood cell~     counts).~   "
89777|NCT02392026|"~     Multicenter, open-label study to evaluate safety and tolerability of Metronidazole Vaginal~     Gel in females 12 to <18 years for the treatment of bacterial vaginosis.~   "
89886|NCT02390596|"~     The study is designed to assess the efficacy and safety of anakinra, an interleukin 1~     receptor antagonist, in patients with Kawasaki disease who failed to respond to standard~     treatment:e.g. one infusion of 2g/kg of intravenous immunoglobulins.~   "
89778|NCT02392013|"~     This study evaluates the effectiveness and implementation of a home-hazard removal program to~     reduce falls in older adults through a community program delivered through the aging services~     network. The investigators will conduct a hybrid effectiveness/implementation trial of 300~     older adults at risk for a fall who will be randomized to a home-hazard removal program or~     usual care and then followed for 12 months. Investigators will look at the number of falls at~     6 months and 12 months.~   "
89779|NCT02392000|"~     Many Veterans of the recent wars in Iraq and Afghanistan struggle with chronic insomnia~     (trouble falling or staying asleep). Most current interventions for insomnia are~     time-consuming, making it difficult for this younger, working group of Veterans to use and~     benefit from these interventions. The investigators will assess whether Veterans find it~     helpful to use two health information technology tools, one for measuring participant sleep~     (the WatchPAT) and one for managing participant sleep (the CBTI Coach). The WatchPAT will~     measure physiological sleep in the Veteran participant's home. The CBTI Coach is a mobile~     health application used on the Veteran's mobile phone or tablet to teach skills that can~     reduce insomnia. The investigators will combine use of the WatchPAT with the CBTI Coach so~     Veterans can self-manage insomnia at home. Participants will record their physiological sleep~     and self-report on their sleep at home during a 6 week self-management program. The~     investigators will measure if Veterans find the tools helpful and easy to use, and which~     Veterans find the tools most helpful.~   "
89780|NCT02391987|"~     This study evaluates the effectiveness of remote tele-monitoring and health coaching in~     helping to reduce hospitalizations in heart failure patients. Half of participants will~     receive tele-monitoring and health coaching, while the other half will receive standard~     health care provided by their chosen provider.~   "
89781|NCT02391974|"~     This is a controlled, randomized, single-blinded, multicenter, prospective clinical study.~      In addition to the standard periodontal treatment procedure on all teeth that need to be~     treated, the 4 teeth with the deepest pockets (between 4 and 6 mm) will be randomized to~     either PERIOSYAL® FILL and oral hygiene or oral hygiene alone.~      The pocket depth will be measured at six sites around each tooth, and only the deepest pocket~     sites of each tooth will be taken into account.~   "
89782|NCT02391961|"~     Primary fatigue represents a major cause of disability in patients with multiple sclerosis~     (MS), being reported in about 90% of cases. Fatigue interferes with everyday functioning but,~     unfortunately, little is known about its mechanisms. The investigators propose a~     characteristic eye movement abnormality (internuclear ophthalmoparesis, INO), commonly~     encountered in MS, as a simple model for primary motor fatigue. The investigators described~     worsening of ocular performance in MS patients with INO following visual tasks (ocular motor~     fatigue), which is likely due to decreased neural conduction along brain pathways injured by~     MS. This mechanism could represent a major component of MS-related primary motor fatigue.~     Relevant to Veterans' care, INO is a significant cause of visual disability, especially when~     complicated by ocular fatigue, and limits daily activities such as reading and driving. The~     investigators propose a medical treatment to improve ocular performance/fatigue in INO, which~     can reduce visual disability and improve quality of life in Veterans with MS.~   "
89783|NCT02391948|"~     The On Track Study is a large multi-site collaboration involving researchers, therapists,~     families, and children with cerebral palsy (CP) from across Canada and the United States. The~     researchers need to better understand how young children who have difficulties with movement~     activities progress and develop in their balance abilities, fitness, strength, health, range~     of motion, self-care, everyday play, and activity participation.~      This study will determine how young children with cerebral palsy or gross motor delays~     progress in many aspects of their physical development and participation in daily life. The~     information collected from this study will help therapists and parents monitor if a child is~     developing as expected in his or her physical development and participation. Then, the health~     care professionals working with children can use the results of this study, in combination~     with the previously completed Move & PLAY study results, to provide the services that are~     most beneficial and meaningful for each child and their family members.~   "
89784|NCT02391935|"~     The primary purpose of this study is to assess the safety profile of RCS-01 injections as~     compared to placebo injections. This study will also measure the impact these injections will~     have on skin markers related to aging through evaluation of gene expression profiles.~      30 participants will be selected for this study based on their health status, current/past~     medications, and ability to adhere to protocol-related requirements. At the first visit and~     after providing informed consent, participants are evaluated against the study~     inclusion/exclusion criteria and provide blood samples for screening assessments (including~     virology). If suitable for study participation, participants will provide a biopsy from the~     scalp from which RCS-01 will be prepared and will have four treatment evaluation sites~     identified on their buttocks, two on each side.~      Study participants will be randomized to one of two treatment subgroups. Participants in the~     RCS-01 Subgroup (n=24) will receive injections of RCS-01 or placebo or a 'sham' injection (a~     needle penetration without injection of liquid). Participants in the the Placebo Subgroup (n=~     6) will be randomized to receive only injections of placebo or sham injections.~      Baseline evaluations of subjects' overall health and skin condition at treatment sites on~     their buttocks will be performed before receipt of injections at Day 0. In addition to~     injections delivered at Day 0, the pre-selected treatment evaluation sites will receive~     intradermal injections of RCS-01 or placebo (cryomedium) or a sham injection four (4) and~     eight (8) weeks after Day 0 according to a randomization schedule for a total of three (3)~     injections per treatment site.~      All participants will return to the clinic for at least 9 visits during the 52-week follow-up~     period to monitor long-term safety. At the 12-week time point, 18 randomly-selected~     participants from the RCS-01 Subgroup will provide biopsies from all injection sites for~     analysis of skin markers related to aging. At the 26-week time point, the remaining~     participants will provide biopsies of all injection sites for histopathological analysis.~   "
89785|NCT02391922|"~     The study evaluates the effect of a first aid course on first aid skills compared to no~     training. The study also evaluates the effect of first-aid instructions given by emergency~     dispatch central over mobile phone on first aid performance to no instructions.~      Half the participants will perform first aid in two scenarios prior to first aid training.~     Half the participants will perform first aid in two scenarios 4 to 5 months after attending a~     first aid course. Half the participants (overall) will receive first aid instructions by~     mobile phone during the scenarios.~   "
89786|NCT02391909|"~     This is a multicenter (at travel clinics), phase 4 observational prospective cohort study in~     healthy adult male and female travelers for whom typhoid vaccination with Vivotif is~     recommended, as per standard practice.~   "
89787|NCT02391896|"~     Computed tomography (CT) is the most accurate test for evaluating patients with thoracic~     disease. However, access to CT is limited due to long wait times and for the sickest patients~     in Hospital who cannot be transported from the ward to the CT scanner. The investigators~     propose to modify a standard X-ray unit to provide more detailed information of the chest~     such that a CT scan is not required for all patients.~   "
89788|NCT02391883|"~     Patients in Clopidogrel therapy alone or in combination with acetylsalicylic acid (Dual~     Antiplatelet Therapy (DAPT) presenting with a hip-fracture represent the surgeon with the~     dilemma of putting the patient at risk of a major blood loss during and after surgery, or~     putting the patient at risk of a thromboembolic event after surgery. The investigators~     hypothesize that the risk of a major blood loss in patients that are still under the effect~     of Clopidogrel or DAPT during or after hip-fracture surgery is relatively low. The~     investigators have conducted a retrospective observational study on hip-fracture patients to~     test this hypothesis.~   "
89789|NCT02391870|"~     Pregnant women with histories of depression are at high risk of depressive relapse during the~     perinatal period, and options for relapse prevention are limited. Mindfulness-based cognitive~     therapy (MBCT) has strong evidence among general populations but has not been studied among~     at risk pregnant women.~      This study is the first phase of a multi-phase project adapting MBCT for perinatal women~     (MBCT-PD). It is being conducted in a collaboration between the University of Colorado, Emory~     University, and Kaiser Permanente at Colorado and Georgia.~   "
89790|NCT02391857|"~     This study aimed to identify the effect of early gastric decompression on the improvement of~     circulation in arrest patients during cardiopulmonary resuscitation at the clinical setting~     of emergency department.~   "
89791|NCT02391844|"~     This is a pilot trial using this product in patients for the management of pain after~     outpatient arthroscopic knee surgery. This is an open-label study and the two active~     ingredients are well known pharmacologic entities.~   "
89792|NCT02391831|"~     NatHis-SMA is a prospective, longitudinal and interventional study of the natural history of~     patients with type 2 and 3 Spinal Muscular Atrophy (SMA). The purpose of this study is to~     characterize the disease course over 2 years and identify prognostic variables of the disease~     and biomarkers of SMA progression, as well as determine the best outcome measures for further~     therapeutics approaches.~   "
89793|NCT02391818|"~     The purpose of this study is to quantify the balance impairments during and after taxane~     chemotherapy. Disability due to balance impairments caused by chemotherapy induced peripheral~     neuropathy (CIPN) can cause falls, injury, and a decline in independence. This results in~     poor treatment outcomes such as greater morbidity and mortality, inability to complete~     treatment protocols, self-limitation of activity, and diminished quality of life.~   "
89794|NCT02391805|"~     This randomized, multicenter, partially double-blind, placebo-controlled study is designed to~     evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antiviral effects~     of treatment with RO6864018 in virologically suppressed participants with chronic HBV~     infection.~   "
89795|NCT02391792|"~     Microparticules (MPs) result from plasma cell membrane remodeling and shedding after cell~     stimulation or apoptosis. MPs are know recognized as a pool of bioactive messengers with~     merging role in pathophysiology of immune and cardiovascular diseases. MPs have been~     characterized during septic shock and may contribute to dissemination of pro-inflammatory and~     procoagulant mediators. This a prospective observational study of circulating MPs and blood~     coagulation in septic shock patients admitted in medical intensive care units (ICUs) of four~     tertiary hospitals at baseline (D1, D2, D3, D4, D7).~   "
89796|NCT02391779|"~     Current recommendations today suggest that use of therapeutic lifestyle changes, such as~     supplementation with specific dietary components and moderate exercise, are appropriate~     interventions for individuals with borderline high blood pressure. Dietary intervention with~     natural products, such as flaxseed, is associated with decreased prevalence of cardiovascular~     disease (Adolphe 2010). Lignans are the active compounds in flaxseed believed to mediate the~     cardiovascular health benefits following flaxseed consumption (Peterson 2010). Clinical~     trials indicate benefit of Flax Lignan Enriched Complex (FLC) (BeneFlax® from Archer Daniels~     Midland, a natural product derived from flaxseed composed of 34-38% lignan) for reducing~     blood cholesterol and glucose (Pan 2007; Zhang 2008) and blood pressure (Cornish 2009).~     Furthermore, a recent study in atherosclerosis patients showed significant clinical benefit~     of flaxseed meal for reducing blood pressure (Rodriguez-Leyva 2013). As a therapeutic~     lifestyle change that could prevent a need to introduce drug therapy in elderly patients, the~     effectiveness of FLC supplementation alone or in combination with moderate exercise merits~     investigation.~   "
89797|NCT02391766|"~     After diagnosis of a dementing illness, patients and their spouses have many concerns related~     to the disease and their future. This often leads to poor psychological well-being and~     reduced health-related quality of life (HRQoL) of the family. Support for Empowerment has~     been proven to be an effective method to improve prognosis of asthma, heart failure,~     osteoarthritis.and diabetes. However empowering interventions have not been studied in~     dementia. Therefore, the investigators aim was to examine, in an objective-oriented group~     intervention, the efficacy of empowerment support program (ESP) on the HRQoL of dementia~     patients and their spousal caregivers as well as on the sense of competence and psychological~     well-being of caregivers.~      Methods: During the years 2014 to 15, 180 dementia patients and their spouses will be~     recruited from memory clinics or day centers and randomized into two arms: 90 patients for~     group-based ESP sessions including topics selected by the participants and the use of the by~     us for us guides, 90 patients will serve as controls in usual community care. Sessions may~     include topics on dementia, active lifestyle and prevention for cognitive decline, spousal~     relationship, future planning and emotional well-being. The patients and spouses will have~     their separate group sessions (ten participants per group) once a week for eight weeks.~   "
89798|NCT02391753|"~     The aim of the study was the define changes LAM morphology, biometric measurements of the LAM~     and genital hiatus at immediate evaluation of pelvic floor and at 3 month after delivery was~     evaluated. We also sought to define the optimal time for evaluation of pelvic floor after~     childbirth~   "
89799|NCT02391740|"~     Describe the expectations of therapeutic education for patients in management of cancer pain.~   "
89800|NCT02391727|"~     A first-in-human evaluation of SYN004, a monoclonal antibody that binds to the EGF receptor~     on cancer cells. Cetuximab, a marketed antibody, has been shown to be effective by inhibiting~     the growth of cancer cells thereby prolonging the life of patients who have received it.~     SYN004 is a closely related monoclonal antibody also binds to the EGF receptor in the same~     way. SYN004 might also inhibit cancer cells and prolong life but has been engineered to avoid~     some of the hypersensitivity reactions known to provoked by cetuximab.~   "
89802|NCT02391701|"~     BACKGROUND:~      The Southern European Atlantic Diet (SEAD) is the traditional diet of Northern Portugal and~     Galicia, a region in northwest Spain. The SEAD has been associated with a lower risk of~     non-fatal acute myocardial infarction. Possible mechanisms of this association may be related~     with a lower concentration of markers of inflammation and with reduced triglycerides,~     insulin, insulin resistance, and systolic blood pressure.~      Aim: To evaluate the effect of an Atlantic Diet on i) lipid profile, ii) markers of~     inflammation, and iii) anthropometric indices in a population-based study~      METHODS:~      This is a non-pharmacological clinical trial study which is performed on a family-oriented~     basis. 250 families (~ 750 children and adults, older than 3 years) were selected to~     participate in the study and randomized into Atlantic Diet (AD) (n=125 families) and control~     (n=125 families) groups. The AD groups participate in a diet program 1 day a month for 3~     months in 120-minute diet sessions and freely receive AD food, characterized by a high intake~     of vegetables, cheese, olive oil, mussels and by wine consumption during meals. Control group~     subjects do not participate in any regular diet activity during this period and did not~     receive additional food. Exclusion criteria are alcoholism, lipid treatment, dementia, and~     terminal disease.~      Weight, BMI, waist circumference (WC), skin folds, nutrient intake from 3-day recalls, food~     frequency questionnaire, physical activity, blood pressure, metabolic function (fasting blood~     glucose, HBA1c, insulin resistance and lipid profile), and inflammation markers (c-reactive~     protein, interleukin 6 and tumor necrosis factor-alpha) are measured at baseline, 3 and 6~     months. Mixed effect models will be performed to assess the significance of changes in the~     cardiometabolic parameters.~      The primary end point is the change in lipid profile compared with baseline and the control~     group arm at the end of Month 6. The secondary exploratory end points were change in~     anthropometric indices and inflammation markers at Month 6.~   "
89803|NCT02391688|"~     Phenotyping is an approach largely used for the evaluation of the activity of cytochromes and~     transporters in vivo. It consists of the administration of probe substances metabolised by a~     specific cytochrome or transported by P-glycoprotein (P-gp) for example, followed by the~     determination of a metabolic ratio or the evaluation of the plasmatic or urinary~     concentrations of the probe substances. The administration of a cocktail containing several~     probe substances allows the simultaneous evaluation of the activity of several cytochromes~     and P-gp in a single test.~      When a cocktail approach is used it is important to make sure that no drug-drug interactions~     occur between the probes within the cocktail. The validation of the lack of interactions,~     which is the aim of the study, consists of demonstrating that there is no difference in the~     pharmacokinetic parameters and/or metabolic ratios when a probe is administered alone or as~     part of the cocktail. The Geneva cocktail consists of caffeine, bupropion, flurbiprofen,~     omeprazole, dextromethorphan, midazolam and fexofenadine for the simultaneous phenotyping of~     CYP1A2, CYP2B6, CYP2C9, CAP2C19, CYP2D6, CYP3A4 and P-gp, respectively.~      Probe and metabolite concentrations will be measured in capillary blood using a dried blood~     spot (DBS) analysis. To further facilitate sampling, a new simple device will be used to~     ensure the precision of capillary blood collection.~   "
89804|NCT02391675|"~     The Hasselt Appendicitis Immunology and Environmental Study (HAPPIEST) aims at characterizing~     factors that influence the development and severity of acute appendicitis. In a cohort of 300~     patients and 300 controls, environmental factors as well as genetic make-up of the innate~     immune system, focusing mainly on pattern recognition, will be analyzed in order to gain~     insight in their relative importance in the pathology of appendicitis. Furthermore,~     populations of micro-organisms present in the gut of patients will be characterized, and the~     interaction between relevant micro-organisms and the innate immune system will be analyzed.~   "
89805|NCT02391662|"~     Cancer incidence is increasing with age and the likelihood of elderly suffering from cancer~     is 1:3. Although many clinical trials include elderly patients, no results for this subgroup~     of patients are available. Since there is no specific recommendations for treatment of~     elderly patients with pancreatic cancer, treatment with gemcitabine alone is the treatment of~     choice for these patients.~      Single-agent gemcitabine is the current standard of care, but the addition of cytotoxic and~     targeted agents to gemcitabine has almost invariably provided no significant survival~     improvement.~      Results obtained recently in the MPACT phase III clinical trial in patients with pancreatic~     cancer treated with nab-paclitaxel combined with gemcitabine have shown improvement in~     overall survival, but due to in this clinical trial was included patients between 27 and 88~     years, it is considered necessary to conduct a specific study for patients over 70 years.~      The aim of this study is to investigate whether the clinical benefit of nab-paclitaxel~     associated with gemcitabine can be extended to elderly patients with pancreatic cancer.~   "
89806|NCT02391649|"~     This proposed randomized controlled trial will test the effectiveness of a problem-solving~     based bibliotherapy program (PSBBP) for Chinese family caregivers in schizophrenia spectrum~     disorders. A repeated-measures, three-group design will be used to evaluate and compare the~     effects between two treatment groups(PSBBP and psycho-education group) and routine outpatient~     service and family support (control group) for 129 randomly selected family caregivers of~     outpatients with schizophrenia-spectrum disorders over a 12-month follow-up.~   "
89807|NCT02391636|"~     Double blinded randomized controlled study~   "
89808|NCT02391623|"~     PF-06427878 is a new compound proposed for the treatment of hyperlipidemia. The primary~     purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of~     multiple oral doses of PF-06427878 in healthy adult subjects.~   "
89809|NCT02391610|"~     The China-Anhui Birth Cohort Study (C-ABCS) was set up to examine the delayed, cumulative and~     interactive effects of maternal environmental exposures on birth outcomes and children's~     development. The C-ABCS recruited pregnant women from six major cities of Anhui province,~     China, between November 2008 and October 2010. A range of data (including demographic,~     obstetric, occupational, nutritional and psychosocial factors) were collected by both~     interviews and laboratory tests. In each trimester, women's blood samples were drawn, and~     pregnancy complications were abstracted from physician's medical records. By the end of 2011,~     birth outcomes/birth defects were observed/identified by clinicians within 12 months after~     the delivery of 11 421 singleton live births of six cities and those outcomes among the~     remaining 2033 live births are still being observed. In addition, 4668 children from~     Ma'anshan city will be further followed up during the pre-school period till they reach~     adolescence to obtain the data on familial environmental exposures as well as children's~     physical, psychological, behavioural and sexual development. The interview data and~     information on laboratory examinations are available on request from archives in the Anhui~     Provincial Key Laboratory of Population Health & Aristogenics.~   "
89810|NCT02391584|"~     Study to assess the safety and efficacy of the XprESS device for transnasal Eustachian tube~     dilation.~   "
89887|NCT02390583|"~     This is an open label randomized controlled trial, comparing two modes of treatment for~     internet addiction (gaming or gambling online) with sleep disorders associated.~   "
89811|NCT02391571|"~     This single-center study is a randomized, double-blind, active-controlled, multiple-dose,~     parallel group study to evaluate the potential withdrawal effects, safety and tolerability,~     and pharmacokinetic and pharmacodynamic effects of multiple doses of oral intact~     Oxycodone/Naltrexone capsules compared to oxycodone in methadone-maintained opioid-dependent~     subjects. The study will consist of a Screening Phase, an inpatient Treatment Phase~     (including a methadone stabilization period, a placebo administration period, a treatment~     administration period and a safety/washout period), and a Follow-up Phase.~   "
89812|NCT02391558|"~     Clinical evaluation of noninvasive OCT Angiography using a Zeiss OCT Prototype to replace~     fluorescein angiography.~   "
89813|NCT02391545|"~     A Two-arm, Phase 1b/2 Study of IPI-145 Administered in Combination with Rituximab or~     Obinutuzumab in Subjects with Previously Untreated CD20+ Follicular Lymphoma.~   "
89814|NCT02391532|"~     The aim of this study is to investigate the effect of daily intake of the probiotic~     Lactobacillus Reuteri on the prevalence and counts of oral Candida in frail elderly living in~     nursery homes.~   "
89815|NCT02391519|"~     Pregnancy elicits adaptive changes in uteroplacental blood flow, which are altered at high~     altitude and may contribute to the observed 3-fold increase in intrauterine growth~     restriction (IUGR) and preeclampsia (PreE). The investigators propose to collect myometrial,~     cord blood, and placental tissue samples from women at high altitude (Summit County) and low~     altitude (Denver) in Colorado in order to determine if residence at altitude during pregnancy~     changes the vasoreactivity of myometrial arteries (MA). If altered MA vasoreactivity is~     found, further studies may be able to link these changes to the increased rates of PreE and~     IUGR at altitude and contribute to the understanding of these two disorders.~   "
89816|NCT02391506|"~     This study will evaluate whether Cartiva is an effective treatment for individuals with~     osteoarthritis of the CMC joint in the hand.~   "
89817|NCT02391493|"~     For bilingual and multilingual patients, brain activation and Electric Stimulation Mapping~     studies have shown that different languages may be localized, at least partially, in distinct~     microanatomical systems located within the same gross anatomical areas.~      The present investigation involves both types of healthy bilinguals with carefully controlled~     proficiency levels, as well as bilingual patients suffering from low-grade glioma.~      Functional magnetic resonance imaging data will be collected while the participants perform a~     picture naming task in blocked conditions for both languages (either English or French) or in~     switch condition (English and French). A stimulation mapping study will be conducted in the~     patients during awake surgery with the same tasks.~   "
89818|NCT02391480|"~     This is a Phase 1, first-in-human, dose escalation study in participants with advanced solid~     tumors to determine the pharmacokinetics, maximum tolerated dose and the recommended Phase 2~     dose of ABBV-075 at different monotherapy dosing schedules. In addition the study will~     evaluate the safety. tolerability and the pharmacokinetics of ABBV-075 monotherapy or~     combination therapy in disease specific expansion cohorts.~   "
89819|NCT02391467|"~     Non invasive methods are the only available methods to stage liver fibrosis during pregnancy.~     The safety of elastometry - ultrasound based - is obvious, as medical supervision of~     pregnancy is based on ultrasonography, both methods using same wavelengths. Therefore, this~     method is sometimes used in pregnant women with recent diagnosis of chronic viral hepatitis~     infection, whereas its validity in pregnant women has never been studied. This lack of data~     justifies our study.~   "
89820|NCT02391454|"~     Rationale: Cancer treatment is increasingly successful, resulting in a rising number of~     cancer survivors. A substantial number of survivors may experience long-term and late side~     effects from their cancer treatment. In addition, evidence is accumulating that an active~     lifestyle positively influences cancer treatment outcome and changes the recurrence rates of~     the disease. Therefore, physical activity (PA) programs are urgently needed and should be~     incorporated in current treatment regimens. It is noted though that cancer patients and~     survivors experience difficulties in remaining physically active. A 'smartphone application'~     (app) may be an accessible way to counteract these problems. The app 'RunKeeper', founded by~     Mr. Jason Jacobs, 2008, FitnessKeeper Inc. (RunKeeper) is a free, widely spread and~     well-known app for self-monitoring PA. Convenient features of RunKeeper are self-monitoring~     PA with GPS or stopwatch, recording progress, goal setting, and personal records. In this~     study the investigators aim to determine if the RunKeeper app use improves PA by~     self-monitoring and empowering PA during or after cancer treatment in comparison with usual~     care in a 12-week follow-up.~      Objective: The primary objective is to identify an improvement in PA as measured by the PASE~     questionnaire when using the RunKeeper app in comparison with usual care for 12 weeks during~     or after cancer treatment. The investigators hypothesize that the RunKeeper app might assist~     in stimulating and improving PA behavior. Secondary objectives are to explore the usability~     of the RunKeeper app.~      Study design: The present study is a single-centre prospective two-armed randomized~     controlled feasibility study.~      Study population: Adult patients diagnosed with cancer currently being treated or under~     surveillance at the department of Medical Oncology at the UMCG.~      Intervention: Patients who give informed consent will be randomized in one of the two study~     arms; 'Group A', usual care (N=15) or 'Group B', usual care + the RunKeeper app (N=15).~     Directly after randomization, Group B will be sent a brief user's manual for RunKeeper and~     requested to install the RunKeeper app. Group B will use the RunKeeper app for 12 weeks to~     self-monitor PA.~      Main study parameters/endpoints: The primary endpoint is to calculate the effect-size of the~     RunKeeper app use for 12 weeks on PA as compared to usual care as measured by the Physical~     Activity Scale for the Elderly (PASE) questionnaire. The investigators hypothesize that the~     RunKeeper app might assist in stimulating and improving PA behavior.~   "
89821|NCT02391441|"~     The investigators will evaluate ventricular reversed remodelling after double lung~     transplantation (LTX) in patients with pulmonary arterial hypertension (PAH), measured with~     cardiac magnetic resonance imaging (MRI). Reversed remodelling will be compared with control~     patients without PAH (e.g. Cystic Fibrosis) who will also undergo LTX.~   "
89822|NCT02391428|"~     Attention deficit hyperactivity disorder (ADHD) is a major problem in children and~     adolescents. Clinical and biochemical evidence suggests that deficiencies of polyunsaturated~     fatty acids (PUFA) could be related to ADHD. PUFAs are the major components of brain with~     important physiologically active functions.~      Aim: Study the relationship between omega3 blood values and ADHD clinical status.~      Methods: The investigators will recruit 30 children, who have been diagnosed with ADHD by a~     child psychiatrist. In addition the investigators will recruit a control group of 30 children~     without ADHD and related neuropsychiatric syndromes. Blood will be taken from all children.~      The ADHD children will be asked to consume omega3 capsules for 6 month. After 3 and 6 months,~     all children will undergo clinical examination and blood tests will be taken for omega3 index~     analysis. Blind frozen samples of isolated red blood cell (RBC) will be analyzed according to~     the omega3 index methodology.~   "
89921|NCT02390141|"~     The trial is a single-centre, randomized, double-blind, phase 1b trial of multiple ascending~     doses of ZP4207 administered s.c. to healthy volunteers (HV) to evaluate the safety,~     tolerability, pharmakocinetic (PK) and pharmacodynamic (PD). Three cohorts of 8 subjects are~     planned. Within each cohort, the subjects will be randomly assigned to five repeated doses of~     ZP4207 or placebo in a 3:1 treatment allocation at trial site.~   "
89823|NCT02391415|"~     Goal of Serum Institute of India Limited (SIIL) is the development of a recombinant urease~     C-deficient listeriolysin expressing BCG vaccine strain (VPM1002) as a safe, well tolerated~     and efficacious vaccine against tuberculosis (TB) for residents in endemic areas and persons~     at risk in non-endemic areas. The new vaccine should be at least as potent as the current~     strain and should be safer than BCG.~      The preceding phase-IIa trial was the first investigation of VPM1002 in newborn infants in a~     high burden setting in South Africa. The vaccination of HIV-unexposed infants with VPM1002~     indicated again safety, tolerability and immunogenicity sufficient to proceed in HIV-exposed~     infants.~      The current study is a multiple site trial in South Africa to evaluate safety and~     immunogenicity in HIV-unexposed and -exposed newborn infants.~   "
89824|NCT02391402|"~     The primary objective of this study is to evaluate the efficacy of Cognitively Augmented~     Behavioral Activation (CABA), a new hybrid treatment for Veterans diagnosed with comorbid~     mild Traumatic Brain Injury (mTBI) and posttraumatic stress disorder (PTSD). The study's~     specific goals are to determine whether: 1) CABA reduces PTSD symptoms in Veterans with~     mTBI/PTSD, 2) CABA reduces cognitive-related functional impairment in Veterans with~     mTBI/PTSD, 3) CABA results in improvements in depression symptoms, cognitive functioning, and~     quality of life in Veterans with mTBI/PTSD; and 4) CABA is an acceptable treatment for~     Veterans with mTBI/PTSD. The overall goal is to develop an evidence-based manualized~     treatment for comorbid mTBI/PTSD that can be readily implemented in Veterans Health~     Administration (VHA) treatment settings.~   "
89825|NCT02391389|"~     Delayed clamping of the umbilical cord (DCC) has been shown to have some benefits for preterm~     infants. Initiation of breathing before cord clamping is also thought to be beneficial. Since~     some preterm infants do not breathe well on their own immediately after birth, assisting~     ventilation during delayed cord clamping might have additional benefit beyond DCC alone.~     VentFirst Pilot will assess feasibility and safety of assisting ventilation of preterm~     infants during 90 seconds of DCC which is essential before proceeding to a randomized~     clinical trial.~   "
89826|NCT02391376|"~     The purpose of this study is to compare the effects generated by the application of three~     different packs on the flexibility of the lower back of sedentary students. Method: Three~     sessions of 15 minutes of superficial heat through a hot pack (moist heat pack-MHP, seed~     pack-SP or gel pack-GP) were applied on the lower back. Pack and lower back temperatures and~     erythema were registered every 5 minutes. Schober test was performed before first session and~     after the third session.~   "
89827|NCT02391363|"~     The purpose of this research study is to see how helpful two different interventions offered~     through the Calmer Life program are in reducing worry and improving mood. The investigators~     also want to understand how a program like Calmer Life can be offered in underserved~     communities.~   "
89828|NCT02391350|"~     Low back pain and sciatica is a common condition resulting in high costs and disability for~     society and affected individuals. Presently there is a lack of evidence for what treatments~     may help this condition early in the course of care. Improved early management could reduce~     risks for persistent disability and high costs. The goal of this project is to examine the~     clinical outcomes and costs associated with adding a physical therapy program to early~     management of patients with low back pain and sciatica within primary care.~   "
89829|NCT02391337|"~     Atrial fibrillation is a common heart rhythm disturbance, causing important discomfort for~     patients, a high risk of stroke, frequent hospital admissions and a two-fold increase in~     death. The number of patients with this condition are expected to double in the next 20~     years. Medications to control heart-rate are used in the majority of patients, although the~     choice of agent is often guided by local preference rather than evidence from controlled~     trials. Despite the fact that patients with atrial fibrillation have high rates of other~     cardiac conditions such as heart failure, clinicians have insufficient evidence to~     personalise the use of different therapies. This feasibility study will allow us to develop a~     range of methods that can characterise patients according to the pumping and relaxing~     function of the heart, the burden of symptoms and to identify new blood markers. In this way,~     the investigators hope to improve clinical practice guidelines, allowing doctors to prescribe~     appropriate treatments for the right patients.~      The research will be focused around a randomised trial of two medication strategies,~     providing much-needed data on the comparison of digoxin and beta-blockers (two commonly-used~     drugs in patients with atrial fibrillation). It will also allow us to identify the best way~     to record patient-reported quality of life and develop robust techniques to determine heart~     function using non-invasive imaging, facilitating the conduct of a large-scale clinical~     trial. The key objectives of the research programme are to define the optimal medications for~     patients with atrial fibrillation and identify the most valid, reproducible and~     cost-effective methods to examine patients. The ultimate aim of the project is to improve~     clinical outcomes in atrial fibrillation, benefiting patients, the National Health Service~     and the global community.~   "
89830|NCT02391324|"~     Robot assisted gait training is seen as a promising intervention for improving the walking~     abilities of children with cerebral palsy, but research to support its effectiveness compared~     to best practice physical therapy is lacking. This research consists of a randomized~     controlled trial (RCT) and a qualitative descriptive study that is linked with the RCT. The~     goal of the RCT is to compare: 1) a walking training program with the Lokomat® robotic device~     (LOK), 2) a functional physical therapy program (fPT) that includes activities to enhance~     balance/co-ordination/endurance and advanced motor skills conducted over 'real ground', 3) a~     combined Lokomat® + functional physical therapy (LOK+fPT) program, and 4) a regular~     maintenance therapy condition (CONT) for ambulatory children and youth with CP (aged 5- 18~     years). The three intervention programs will consist of sixteen 50-minute sessions given~     twice weekly over 8 to 10 weeks. The primary objective of the RCT is to compare the four~     groups with respect to walking-related motor skills as measured by the Gross Motor Function~     Measure. The secondary objectives are to compare each intervention's impact on walking~     abilities, individualized goals, fitness, balance, physical activity levels, child's belief~     in ability to do physical activity, participation and quality of life. The investigators will~     also evaluate the extent of carryover or progress 3 months after the intervention. The~     qualitative part of the study will consist of interviews of children and parents after they~     have finished the study intervention. The information from the interviews will assist us with~     interpretation of the outcome results (areas of impact and amount of change) from the RCT. In~     particular, the interviews will 1) provide insight into their experiences with the trial~     interventions, 2) identify the mobility-related outcomes that are important to families and~     the factors that influence their preferences, and 3) explain the family values, experiences~     and contextual factors that influenced participation in the study. This research will provide~     information needed to allow clinicians and families to make informed choices about Lokomat~     therapy and physical therapy options in relation to their child's functional goals and~     abilities.~   "
89831|NCT02391311|"~     The goal of this study is to conduct a small, self-contained project to test the hypothesis~     that tDCS will augment SOP cognitive remediation therapy (CRT) in older HIV+ adults. The~     investigators will randomly assign 60 HIV+ older adults (i.e., ≥ 50 years old) to 10-hours in~     either a SOP CRT + sham tDCS condition (n=30) or SOP CRT + active tDCS condition (n=30) and~     examine neurocognitive functioning at baseline and 6 weeks post-intervention. Hypothesis 1:~     The SOP CRT + active tDCS condition will show larger proximal (i.e., SOP) gains than the SOP~     CRT + sham tDCS condition. Hypothesis 2: The active tDCS condition will demonstrate~     generalization to secondary neurocognitive domains compared to the sham tDCS condition.~   "
91709|NCT02366767|"~     The overall aim of this research proposal is to determine the safety, feasibility and~     efficacy of an automatic closed-loop insulin delivery system.~   "
89833|NCT02391285|"~     To assess the potential clinical utility of measuring pelvic floor muscle tone after~     childbirth by vaginal dynamometry, the investigators will study 50 consecutive consenting~     first attendees of the Jessop Wing perineal trauma clinic. In addition to clinical and~     imaging assessment routinely offered women at this clinic, the investigators will measure~     their active and passive pelvic floor muscle tone using the Auckland vaginal elastometer. The~     investigators will also assess structural pelvic floor muscle damage (PFMD) in a subset of 10~     women (5 symptomatic and 5 asymptomatic) by Magnetic Resonance Imaging (MR) scan of the~     pelvic hiatus. The investigators will then determine the predictive capacity of vaginal~     elastometry for symptoms of pelvic floor damage, findings of endoanal sonography, and MR~     scans of the pelvic floor hiatus. The investigators will determine if vaginal elastometry can~     prove an objective and accurate frontline assessment tool for the management of PFMD~     following childbirth. Our observations will generate vital data for powering and designing a~     large clinical trial evaluating the potential use of the vaginal elastometer as a first line~     assessment tool of PFMD in the postnatal period. Data will also inform the design of a~     personalised model for predicting and managing pelvic floor muscle damage during childbirth.~   "
89834|NCT02391272|"~     The project was undertaking by Qilu Hospital of Shandong University and other well-known~     hospitals in China. Aims at evaluating efficacy and safety of rhTPO in management of ITP in~     pregnancy.~   "
89835|NCT02391259|"~     This is a multicenter, randomized, double-blind, placebo-controlled, sequential rising~     single-dose study in which approximately 56 subjects with SLE will be enrolled in 7 dosing~     cohorts~   "
89836|NCT02391246|"~     Gliomas are the most common malignant primary central nervous system (CNS) tumours. When~     high-grade gliomas (HGG) recur, subsequent magnetic resonance (MRI) imaging, with additional~     sequences is required.The Positron Emission Tomography (PET) radiotracer~     [18F]-fluorodeoxyglucose (FDG) will be used in this study to distinguish between changes seen~     on MRI which can be a reflection of pseudoprogression, radiation necrosis, or recurrence.~   "
89837|NCT02391233|"~     The proposed study is a randomized controlled trial (RCT) that will rigorously evaluate the~     effectiveness and cost-effectiveness of delivering a multimedia evidence-based intervention~     (WORTH) and streamlined HIV testing to prevent human immunodeficiency virus (HIV) and other~     sexually transmitted infections (STIs) with Black/African-American (hereafter referred to as~     Black) women drug users in probation sites in New York City (NYC), compared to streamlined~     HIV testing alone. Repeated assessments will occur at baseline and 3, 6, and 12-months post~     intervention. The primary outcomes will be to reduce cumulative incidence of biologically~     confirmed STIs (i.e., Chlamydia, gonorrhea and trichomonas and the number of unprotected sex~     acts.~   "
89838|NCT02391220|"~     This study evaluates the effect of a symbiotic fermented milk on health-related quality of~     life and irritable bowel syndrome (IBS) symptoms in patients with constipation-predominant~     IBS.~   "
89839|NCT02391207|"~     Major hepatectomies are generally selected for tumors involving the hepatic vein (HV) at the~     caval confluence (CC). As alternative, HV reconstruction has been proposed. The present study~     aimed to evaluate the feasibility and safety of a HV-sparing policy guided by intraoperative~     ultrasonography (IOUS) in a cohort of patients having at least one colorectal liver~     metastasis (CLM) in contact with a HV at CC. HV section can be avoided in the large majority~     of cases thanking to CLMs detachment or to HV partial resection or reconstruction: this~     policy seems feasible, safe, reduces the need of major hepatectomies, and oncologically~     provides an adequate local control.~   "
89840|NCT02391194|"~     This is a Phase 1, open-label, dose escalation study in women with primary, non-recurrent~     breast cancer undergoing surgery. AVB-620 will be administered prior to surgery.~   "
89841|NCT02391181|"~     A Clinical Trial to Demonstrate the Comparability of the Two Iron Sucrose Injection Solutions~     Iron Sucrose Azad of Azad Pharma AG and Venofer® of Vifor Pharma AG. The Hypothesis is That~     Both Iron Sucrose Injection Solutions Reveal the Same Active Substance Availability in the~     Blood Circuit.~   "
89842|NCT02391168|"~     A multi-center, prospective cohort study on the natural history of fatty liver disease in~     China~   "
89843|NCT02391155|"~     In this study, the investigators aimed to evaluate to the efficacy of the needle type used in~     follicular flushing in oocyte retrieval in the poorest responders undergoing IVF.~   "
89844|NCT02391142|"~     The purpose of this study is to evaluate the effect of Cardiac Sympathetic Blockade on~     Mortality, re-hospitalization rate, symptoms, quality of life, exercise tolerance, cardiac~     structure, systolic function, electrical activities and concentration of B - type natriuretic~     peptide precursor in patients with Chronic Heart Failure.~   "
89845|NCT02391129|"~     The purpose of this study was to compare the clinical (range of motion, weight bearing,~     quality of life) and radiographic outcome (boney consolidation) between open reduction and~     internal fixation using locking compression plates with revision prosthesis using a~     non-cemented long femoral stem in a group of patients with a Vancouver type-B2, B3 and C~     periprosthetic fracture after primary total hip replacement.~   "
89846|NCT02391116|"~     To assess the potential efficacy (in terms of objective response) of single agent copanlisib~     in patients with relapsed or refractory Diffuse large B-cell lymphoma (DLBCL) and assess the~     relationship between efficacy and a potentially predictive biomarker~   "
89847|NCT02391103|"~     The purposes of this study are 1) to determine whether neuromuscular electrical stimulation~     (NMES) is effective in preventing loss of muscle mass and strength and 2) to observe the time~     variation of MLT and strength from preoperative day to hospital discharge.~   "
89848|NCT02391090|"~     Stable Asthma patients (GINA 1-2) stay 6 days in a row for 4 hours per day in a hypoxic~     chamber simulating 2800m above sea level. Study participants will be blinded to the treatment~     given and divided into a hypoxic and a sham group (about 360m above sea level).~      Effects of this intermittent hypoxia on the asthmatic inflammation of these patients will be~     measured. The primary endpoint is the change in forced exhaled nitric oxide (FeNO) before and~     after the study. Secondary endpoints include blood parameters, lung function testing and~     questionnaires.~   "
89849|NCT02391077|"~     There is a potential of bacterial overgrowth under the foreskin in the sub-preputial space,~     therefore we would like to investigate possible techniques to reduce this potential.~   "
89850|NCT02391064|"~     Cognitive disorders are common in early stage of Multiple Sclerosis (MS) and concern mainly~     information processing speed (IPS) which also influences with other cognitive functions such~     as attention, working memory and executive functions. The investigators validated a~     computerized test of IPS, the computerized speed cognitive test (CSCT), which can detect~     disorders of IPS in MS. A short battery was proposed, the brief cognitive assessment for~     multiple sclerosis (BICAMS) battery, which combines the Symbol-Digit Modalities-test (SDMT),~     a test of the IPS, and two measures of episodic memory. On the same principle, the~     investigators propose to validate a short computerized battery to improve the feasibility~     (brief computerized cognitive assessment (BCCAMS)) combining the CSCT and a computerized test~     of visual episodic memory.~      Purpose: to establish the screening value of a brief computerized cognitive assessment~     (BCCAMS) combining the computerized speed cognitive test (CSCT) and a new computerized~     episodic visual memory test (CEVMT) in French-speaking patients with multiple sclerosis as~     compared to a reference battery (MACFIMS).~   "
89851|NCT02391051|"~     This trial examines the feasibility and toxicity of focal brachytherapy in patients with~     low-risk prostate cancer.~   "
89852|NCT02391038|"~     The purpose of this study is to evaluate the effects of MLN0264 in previously treated Asian~     participants with Advanced Gastrointestinal (GI) Carcinoma (Phase 1) or Metastatic or~     Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma (Phase 2) Expressing Guanylyl~     Cyclase C (GCC).~   "
89853|NCT02391025|"~     This is a single center cross-sectional imaging study investigating the use of gallium-68~     citrate PET in patients with metastatic castration-resistant prostate cancer who are planning~     to undergo a metastatic tumor biopsy on protocol CC# 125519.~      The study population will consist of patients with metastatic castration-resistant prostate~     cancer who are undergoing a metastatic tumor biopsy as part of clinical protocol CC# 125519,~     with evidence of resistance to androgen signaling inhibition.~      The study will involve gallium-68 PET scan obtained at single time point, followed by~     radiographically-guided metastatic tumor biopsy within 14 days of PET scan.~   "
89854|NCT02391012|"~     Fecal microbial treatment (FMT) is a treatment that utilizes the microbiota of a healthy~     intestine as a probiotic preparation. The feces of a healthy individual is fluidized and than~     inserted into the intestinal tract of a sick individual, assuming that the healthy flora will~     colonize and cure the intestine. There are reports of the efficacy of this treatment for~     inflammatory bowel disease but currently the numbers are small.~      aim: To investigate whether use of FMT will bring improvement for colitis in IBD patients .~     Methods: The patients will undergo full colonoscopy, the stool preparation will be infused~     through the colonoscope during withdrawal of the instrument.~   "
89855|NCT02390999|"~     3500 people suffer from out of hospital cardiac arrest each year in Denmark. Therapeutic~     hypothermia to 33 degrees celsius is now standard treatment of comatose cardiac arrest~     patients. The investigators are challenged in our attempt to predict outcome of these~     patients by both low body temperature in itself and the sedative and relaxing drugs used to~     keep the patient in a coma.~      This study is a substudy in a large international multicenter randomized trial that~     investigates the possible benefit of 48 hours of therapeutic hypothermia versus todays~     standard of 24 hours.~      In this substudy the investigators will approach early prediction of neurological outcome~     using a combination of new examinations backed up by well established ones to engage this~     challenge from different angles and find a battery of combined examinations, that together~     will enable us to accurately predict outcome at an earlier stage.~      Our examinations have been chosen from the three fields of neurophysiology, biochemistry and~     neurology and consist of electroencephalography (EEG), somatosensory evoked potentials (SEP),~     biomarkers and clinical examinations such as brain stem reflexes chosen for their prognostic~     reliability.~   "
89856|NCT02390986|"~     The purpose of this clinical trial is to evaluate the long term safety and efficacy of~     LON002.~   "
89857|NCT02390973|"~     Bariatric surgery procedures induce weight loss through restriction and/or malabsorption. The~     mechanisms underlying type 2 diabetes remission and others metabolic improvements after~     Roux-en-Y Gastric Bypass (RYGB), sleeve gastrectomy (SG) or biliopancreatic diversion with~     duodenal switch (BPD-DS) have not yet been formally studied. The investigators propose a~     longitudinal study with the overall objective of measuring the long-term impact of these~     three bariatric surgeries (RYGB, SG, BPD-DS) on metabolic, renal and cardiovascular fate in~     patients with type 2 diabetes. The investigators overall hypothesis is that some bariatric~     procedures generate hitherto unrecognized effects on many disease-related outcomes, which~     greatly contributes to their beneficial impact in diabetic patients. The investigators~     propose 3 specific aims: 1) to establish the long term effect of the three surgeries on the~     metabolic recovery and quality of life in groups of diabetic patients treated with insulin,~     hypoglycemic agents or diet; 2) to establish the long term impact of the three surgeries on~     renal and cardiovascular functions in subgroup of patients with these conditions; 3) to~     compare metabolic impact of surgeries to those of best medical care for diabetes in a~     non-surgical control group. For most severely obese patients, lifestyle interventions,~     perhaps effective in inducing short-lived weight losses, are ineffective for long-term weight~     loss maintenance and durable metabolic recovery. The increasing popularity of obesity~     surgeries calls for a better understanding of the underlying mechanisms. This is especially~     true and urgent when considering that knowledge on the relative impact of each procedure~     (i.e. SG vs. RYGB and BPD-DS) in resolving T2D is still limited. Better knowledge on each of~     the procedures will allow stronger scientific rationale for selecting the right surgery for~     the right patient and improve care for the severely obese individual.~   "
89858|NCT02390960|"~     This is a Phase 2a, single-dose, double-blind, placebo-controlled, 2-way crossover study in~     men with ED. A single 2 gram dose of SST-6006 topical cream 5% w/w (formulated to deliver 100~     mg of sildenafil) or a topical placebo cream will be applied to the penile shaft and glans.~     There are 4 study phases: the Initial Patient Screening Phase (Visit 1, an Off Site 4-Week~     Run-in Period and Visit 2), the Final Patient Screening Phase (Visit 3), the SST-6006/Placebo~     Double-Blind Dosing Phase (Visits 4-5), and the Follow-up Phase. Primary outcomes will be be~     evaluated at Weeks 7 and 8 of the study~   "
89859|NCT02390947|"~     Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and~     Flt3, whose anti-tumor and anti-angiogenesis effects have been validated in preclinical~     tests. In PhaseⅡb study, a significantly improved Progression Free Survival (PFS) was found~     in patients with advanced colorectal cancer treated with Famitinib compared to placebo. On~     the other hand, the toxicity of Famitinib was manageable in both PhaseⅠand Ⅱb studies.~      The purpose of this study is to determine whether Famitinib can improve Overall Survival (OS)~     compared with placebo in total 540 patients with advanced colorectal cancer who have failed~     in previously received at least two lines of standard chemotherapy.~   "
89922|NCT02390128|"~     This is an observational study in pregnant mothers and their newborn babies. The rationale of~     the study is to examine early markers of the effects of iodine insufficiency during pregnancy~     on thyroid stimulating hormone (TSH) and thyroglobulin in mother and baby.~   "
89860|NCT02390934|"~     The purpose of this Phase II single-arm study is to evaluate the efficacy of Radium-223 in~     treating bone lesions from differentiated thyroid cancer that are I-131 refractory. Based on~     the results of the phase III trial, the protocol using an injection of Radium-223 activity of~     50 kBq/kg b.w. given 6 times at 4 weeks interval will be applied. The end point of this study~     will be the evaluation of Radium-223 efficacy one month after 3 administrations, i.e. at 3~     months after the first injection. If disease progression at that time is excluded, patients~     will be treated with 3 further injections for a total of 6 administrations of Radium-223. The~     principal response criterion at 3 and 6 months will be the metabolic response on FDG PET/CT,~     but other imaging techniques will also be performed: axial skeleton MRI, 99mTc-HMDP bone scan~     and FNa PET/CT. Axial skeleton MRI is the reference for soft tissue study. 99mTc- HMDP bone~     scan is the most used and available routine tool to detect bone metastases in cancer~     patients, but its sensitivity in patients with bone metastases from thyroid cancer is low,~     because most lesions are lytic [23]. 18FNa PET/CT shows higher sensitivity than 99mTc-HMDP~     bone scan to detect bone lesions in cancer patients and is able to detect micrometastases~     that are not seen on bone scan [24] [25]. Preliminary results show some interest of using~     this tracer to evaluate the sclerotic component of bone metastases from thyroid cancer [26].~     Furthermore preliminary data show that FNa PET/CT can be useful to quantify response to~     Radium-223 in prostate cancer. In only five patients evaluated by FNa PET/CT at baseline, 6~     weeks and 12 weeks after 100 KBq/Kg of Radium-223, semiquantitative analysis by SUV max~     showed a relationship between PSA and SUV max level decrease in 3 patients (-44%, -31%, -27%~     vs -52%, -75, and -49% respectively) [27].~      Finally bone metastases that are visible on morphological imaging (CT scan or on RI) are~     frequently submitted to local treatment modalities, and this may induce fibrosis and~     recalcification. Therefore, already treated metastases and not treated metastases will be~     studied separately as two separate subgroups of target lesions.~   "
89861|NCT02390921|"~     Bariatric surgery is the most effective long-term treatment of morbid obesity treatment, so~     you can maintain weight loss enduringly with improvement or resolution of comorbidity and~     mortality reduction. All bariatric surgery techniques in postoperative induce a significant~     reduction in food intake and / or absorption of nutrients and therefore may be associated~     with a risk of nutritional deficiency, which increases over the years after surgery. One of~     the nutrients whose absorption is affected significantly is iron, women of childbearing age~     segment most vulnerable being. A significant percentage of these women require oral~     supplementation with high doses of iron and often parenteral treatment is needed for~     digestive intolerance or therapeutic failure.~      Hypothesis: The liposome orally administered iron could represent a therapeutic alternative~     in women of childbearing age, previously undergone bariatric surgery that currently require~     parenteral iron therapy.~      Objectives: To evaluate the tolerability and efficacy of oral iron liposome female patients~     previously undergone bariatric surgery that currently require parenteral replacement therapy,~     as well as the impact on quality of life.~      Methods: a single center, open, prospective, interventional, in 40 women of childbearing age,~     previously undergone bariatric surgery, which currently require intravenous iron therapy~     chronically. Subjects will be divided into 2 parallel groups: 20 cases and 20 controls~     matched for age, level of Hb, year after surgery and percentage of weight lost.~      Relevance: This study will allow us to identify an alternative treatment with oral iron in~     the case of patients with severe iron deficiency after bariatric surgery, which currently~     require parenteral iron therapy due to intolerance to current oral products or therapeutic~     failure. At the same time it could help reduce healthcare costs and improve the quality of~     life of these patients, who will not have to enter periodically in solitary day hospital for~     administration of parenteral iron.~   "
89862|NCT02390908|"~     Alcohol use is increasingly recognized as a key factor in morbidity and mortality among~     HIV-positive individuals and represents an important public health concern, given its~     associations with medication non-adherence, increases in viral load, poor immunologic~     outcomes (lower CD4 counts), drug resistance, lower health care utilization, comorbidities~     (HIV/viral hepatitis coinfection), and poor health outcomes overall. Adherence to HIV~     medications has a double public health benefit, both in terms of slowing disease progression~     and improving health outcomes among HIV-positive individuals and in helping to curb the~     sexual transmission of HIV. The objective of this study is to implement a multisite~     comparative effectiveness trial in real-world clinical settings with three intensities of~     treatment to test the clinical and cost effectiveness of an efficacious, theory-based~     behavioral intervention (PLUS) in improving ART-adherence and alcohol-related outcomes among~     HIV-positive individuals who drink alcohol at harmful or hazardous levels. The study is being~     conducted in collaboration between the Center for HIV Educational Studies and Training~     (CHEST) at Hunter College, CUNY and the Spencer Cox Center for Health at the Institute for~     Advanced Medicine, Mount Sinai Health System.~   "
89863|NCT02390895|"~     The purpose of this study is to determine the feasibility of prenatal minimally-invasive~     fetoscopic closure with i) uterine exteriorization for a minimally-invasive repair under~     amniotic carbon dioxide insufflation ii) two trocars for the dissection and the cover with~     one patch or the suture of the skin edges by stitch~   "
89864|NCT02390882|"~     The main objective of this study is to evaluate efficacy and safety of (Tamsulosin) HGP0412~     and HIP1402 in patients with Benign Prostatic Hyperplasia~   "
89865|NCT02390869|"~     A randomized phase III multicenter trial assessing efficacy and toxicity of a combination of~     Rituximab and Lenalidomide (R2) vs Rituximab alone as maintenance after induction's~     chemoimmunotherapy with Rituximab-Bendamustine for relapsed/refractory FL patients not~     eligible for autologous transplantation (ASCT).~   "
89866|NCT02390856|"~     Open reduction and internal fixation (ORIF) of unstable distal radius fractures is performed~     using a variety of fixation techniques. The most common method is fixed angle volar plate~     application. The investigators plan to compare the outcomes of fixed angle volar plating with~     a novel FDA approved intramedullary fixation device, Conventus DRS.~   "
89867|NCT02390843|"~     This is a Phase I trial with new experimental drugs such as simvastatin in combination with~     topotecan and cyclophosphamide in the hopes of finding a drug that may work against tumors~     that have come back or that have not responded to standard therapy. This study will define~     toxicity of high dose simvastatin in combination with topotecan and cyclophosphamide and~     evaluate for cholesterol levels and IL6/STAT3 pathway changes as biomarkers of patient~     response.~   "
89868|NCT02390830|"~     Background. Balance disorders and falls are common in People with Multiple Sclerosis (PwMS)~     Objective: Our hypothesis was that PwMS treated for balance disorders would reduce balance~     disorders and frequency of falls.~      Methods: A bi-centre randomised Rater-blinded controlled trial. Participants in both groups~     received 20 treatment sessions. Participants in the intervention group received treatment~     aimed at improving control of the position and movement of the centre of mass and body~     segments. Participants in the control group received treatments to reduce limitations at~     activity and body function level.~      Group allocation was done by an independent clinician by a randomization list made before the~     beginning of the study. Group allocation was kept concealed throughout the study and~     participants were not aware of group assignment.~      Data was analyzed according to a preplanned protocol by using an intention to treat approach.~   "
89869|NCT02390817|"~     The study will be performed to evaluate motor response and awareness with using sugammadex~     during wakeup procedure in spine surgery. The investigator's goal is to investigate the~     effect of sugammadex on the state of consciousness and motor-somatosensorial evoked~     potentials.~   "
91996|NCT02362984|"~     This is a prospective, randomized, double-blind, and controlled clinical study to investigate~     the effects of DLBS1033 in conjunction with standard therapy compared to standard therapy~     alone in acute ischemic stroke patients.~   "
89870|NCT02390804|"~     The objective of this study is to compare postoperative pain between single-port access total~     laparoscopic hysterectomy (SPA-TLH) using a transumbilical single-port system and~     conventional multi (three)-port access total laparoscopic hysterectomy (MPA-TLH). A~     prospective study was conducted on women who underwent SPA-TLH and MPA-TLH for benign~     gynecologic diseases from March 2014 through January 2015. The study enrolled 60 patients and~     postoperative pain and operative outcomes were examined.~   "
89871|NCT02390791|"~     Cluster randomized controlled trial to evaluate the general effectiveness of intervention~     compared to control on medication continuity as measured by prescriptions written and other~     more proximal outcomes during the first six months of treatment.~   "
89872|NCT02390778|"~     The objectives of the study were: To (1) describe the epidemiology of emotional distress~     experienced by Ugandan violence researchers; to (2) assess the effectiveness of group~     debriefings in mitigating secondary distress; to (3) assess risk and protective factors.~     Eligible participants were 59 Ugandan researchers employed by the Good Schools Study (GSS,~     NCT01678846) to interview children and adults who experienced violence. Recruited~     participants were randomly assigned to group debriefings (intervention) or film viewing~     (control). The primary outcome was change in levels of emotional distress.~   "
89873|NCT02390765|"~     Background:~      - Studies show that many factors affect children s eating behavior and health. These include~     sleep, mood, thinking skills, and genetics. Studying children over time may identify children~     at higher risk for eating-related health concerns.~      Objective:~      - To understand how genes and environment influence eating behavior and health over time.~      Eligibility:~      - Children ages 8 17 in good general health.~      Design:~        -  Screening visit 1: Medical history, physical exam, body measurements, and questions.~        -  14 days: Participants will wear a wrist monitor and answer smartphone prompts about~          eating and mood. They may give a stool sample.~        -  Screening visit 2:~        -  Body measurements.~        -  Saliva, urine, and blood samples.~        -  Heart tests.~        -  Meals provided (after fasting overnight).~        -  Questionnaires and interview.~        -  Behavior, thinking, and exercise tests.~        -  X-ray of left wrist and full body.<TAB>~        -  Some parents may have medical history, physical exam, and questions at screening visits.~          They may answer questions at the yearly visits.~        -  Participants will have up to 6 yearly visits. They will give a urine sample and body~          measurements, and repeat the X-rays. They will have questions and behavior and thinking~          tasks. They may give stool samples. Visits will range from 3 to 8 hours.~        -  Participants may choose to participate in other studies:~        -  Stress and Hormones, 1 visit: While resting, participants will give saliva samples and~          have their heart monitored. Then they will do math. They will repeat the resting part,~          then do a computer task.~        -  Brain Imaging, 2 visits: Twice, participants will perform tasks with a magnetic cone on~          their head then answer questions. Once, they will have an MRI, lying still in a scanner~          with a coil on their head.~        -  Sleep, 2 visits: Participants will have food provided, answer questions and do tasks.~      Participants will be compensated for the time and inconvenience involved with completing~     study procedures.~   "
89874|NCT02390752|"~     Background:~      - Some people with cancer have solid tumors. Others have refractory leukemia. This doesn t go~     away after treatment. Researchers want to see if a drug called PLX3397 can shrink tumors or~     stop them from growing.~      Objectives:~      - To find the highest safe dose and side effects of PLX3397. To see if it helps treat certain~     types of cancer.~      Eligibility:~        -  People ages 3 22 with a solid tumor or leukemia that has returned or not responded to~          cancer therapies.~        -  For Phase II, people ages 3 31 with a Neurofibromatosis Type 1 (NF1) Associated~          Plexiform Neurofibroma (PN) that cannot be removed with surgery.~      Design:~        -  Participants will be screened with:~        -  Medical history~        -  Physical exam~        -  Blood and urine tests~        -  Heart tests~        -  Scans or other tests of the tumor~        -  Participants will take PLX3397 as a capsule once daily for a 28-day cycle. They can do~          this for up to 2 years.~        -  During the study, participants will have many tests and procedures. They include repeats~          of the screening tests. Participants will keep a diary of symptoms.~        -  Participants with solid tumors will have scans or x-rays.~        -  Participants with NF1 PN will have MRI scans.~        -  Participants with leukemia will have blood tests. They may have a bone marrow sample~          taken.~        -  Some participants may have a biopsy.~        -  When finished taking PLX3397, participants will have follow-up visits. They will repeat~          the screening tests and note side effects.~        -  Phase II will follow the same procedures as Phase I above, but participants will also~          fill out questionnaires about their pain and quality of life.~   "
89875|NCT02390739|"~     Background~      The NCI Surgery Branch has developed an experimental therapy for treating patient with~     metastatic thyroid cancer that involves taking white blood cells from the patient, growing~     them in the laboratory in large numbers, genetically modifying these specific cells with a~     type of virus (retrovirus) to attack only the tumor cells, and then giving the cells back to~     the patient. This type of therapy is called gene transfer. In this protocol, we are modifying~     the patient s white blood cells with a retrovirus that has the gene for anti-thyroglobulin~     incorporated in the retrovirus.~      Objectives:~      The purpose of this study is to see if these tumor fighting cells (genetically modified~     cells) that express the receptor for the thyroglobulin molecule on their surface can cause~     thyroid tumors to shrink and to see if this treatment is safe.~      Eligibility:~      <TAB>Adults 18 and older with thyroid cancer that has the thyroglobulin molecule on tumor~     surfaces~      Design:~      <TAB>Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and~     undergo a history and physical examination, scans, x-rays, lab tests, and other tests as~     needed~      <TAB>Leukapheresis: If the patients meet all of the requirements for the study they will~     undergo leukapheresis to obtain white blood cells to make the anti- thyroglobulin cells.~     {Leukapheresis is a common procedure, which removes only the white blood cells from the~     patient.}~      <TAB>Treatment: Once their cells have grown, the patients will be admitted to the hospital~     for the conditioning chemotherapy, the anti-thyroglobulin cells and aldesleukin. They will~     stay in the hospital for about 4 weeks for the treatment.~      Follow up:~      Patients will return to the clinic for a physical exam, review of side effects, lab tests,~     and scans about every 1-3 months for the first year, and then every 6 months to 1 year as~     long as their tumors are shrinking. Follow up visits take up to 2 days.~   "
89876|NCT02390726|"~     The purpose of this study is to evaluate the effectiveness of Fecal Microbiota Transplant~     (FMT) for treating patients with mild to moderate Ulcerative Colitis (UC). Even with the~     expanding choices of medication for UC, physicians and patients are still in search of highly~     effective and safe medications with minimal side effects. FMT has been approved for the~     treatment of a bacterial infection called Clostridium difficile. In this setting, FMT has~     been proven to be an effective and safe alternative therapy with zero reported serious~     adverse events from patients that have had this treatment.~      The providers that are conducting this study hypothesize that delivering microbes from a~     healthy human gut can help treat the damages caused by UC. This is done by transplanting~     fecal material, which contains a highly complex and dense community of healthy microbes,~     including bacteria, fungi and viruses. This collection of microbes is referred to as a~     microbiome. Preliminary studies suggest that alteration of the microbiome can help treat UC.~   "
89888|NCT02390570|"~     This study is designed to answer why patient capacity (i.e. patient available abilities and~     resources to enact self-care and access healthcare) is not regularly documented in the~     Electronic Medical Record (EMR) in a way that is useful for clinicians.~      Through the implementation of communication tools designed for patient capacity assessment~     and engagement of stakeholders in a process of user-centered design, the study team~     hypothesizes that the study can help clinicians elicit this information in conversation and~     regularly document it in the medical record for future healthcare discussions.~   "
89877|NCT02390713|"~     This ring aimed to preserve an intra-hepatic porto-caval gradient inferior to 5 mm Hg during~     and after major hepatectomy (48h) to protect the liver during the initial phases of liver~     regeneration. Morphological features of MID-AVRTM allow its intra corporeal opening and~     percutaneously removal after an balloon inflation with 5 ml of physiological serum. MID-AVRTM~     had been developed in pig where it had proved its efficiency to improve liver function after~     75% hepatectomy and its capacity to be removed percutaneously. Aim of this feasibility study~     (Phase I/II) is to prove in series of 3 evaluable patients (Phase A) then 6 evaluable~     patients (Phase B) that MID-AVRTM could be used in human without deleterious consequence. In~     phase A, MID-AVRTM is dispose around the portal vein before and during a major hepatectomy~     performed on healthy liver and removed before abdominal closure. If phase A results confirmed~     that MID-AVRTM well modulates portal pressure and is easily opened and removed by acute~     inflation, the phase B will be started. In phase B, MID-AVRTM will be dispose around the~     portal vein before major hepatectomy on healthy liver and conserved 48 hours before to be~     removed percutaneously at the operating room.~   "
89878|NCT02390700|"~     The purpose of this study is to evaluate the incidence and management of infusion reactions~     with Golimumab intravenous infusion.~   "
89879|NCT02390687|"~     Periodontitis is an infectious inflammatory disease. Bacteria modulate the inflammatory~     response and alter the diversity of periodontal disease. In recent years, various~     host-response modulation therapies have been developed to block the pathways responsible for~     periodontal tissue breakdown.~      There have been significant changes with respect to the effectiveness of, and attitudes~     towards conventional antimicrobial therapy to combat disease. With the threat of widespread~     antibiotic resistance rendering many antibiotics useless against important diseases, there is~     an increased necessity not only to minimise antibiotic use and develop novel~     non-antibiotic-based treatments, but also to raise the profile of disease prevention. One~     approach that has gained interest over recent years is the use of probiotic bacteria for oral~     applications. The rationale for their use in oral health care stems from the increase in~     evidence that supports their claims for benefit for a range of diseases. Lactobacilli play an~     important role in the maintenance of health by stimulating the natural immunity as well as by~     contributing to the balance of the microflora, by interacting with the other members of the~     flora. The application of health promoting bacteria for therapeutic purposes, is one of the~     strongest emerging fields. Time has come to shift the paradigm of the treatment from specific~     bacteria elimination to alteration of the bacterial ecology by using probiotics.~      So the purpose of this study is to discover a more promising approach for the treatment of~     chronic periodontitis .~   "
89880|NCT02390674|"~     Routine primary percutaneous coronary intervention (PPCI) for a heart attack involves opening~     a blocked artery with a balloon then inserting a metal scaffold (stent) to hold the artery~     open. During this procedure inflammation can occur causing further damage to the heart. The~     objective of this trial is to determine whether administration of the drug ciclosporin prior~     to PPCI reduces the amount of damage to the heart relative to treatment with placebo. The~     damage to the heart is assessed after 12 weeks by an magnetic resonance imaging (MRI) scan.~     Patients are followed-up after 12 months participation in the study.~      This is a single centre study looking to recruit 68 patients.~   "
89881|NCT02390661|"~     The proposed study is randomised controlled trial where informed and consenting patients who~     have a Mammosite/SAVI device placed, are randomized into two groups: a control group that has~     the device removed in the traditional manner without having a drain placed, and an~     experimental group that will have a penrose drain placed under sterile conditions at the time~     of removal of their device. The drain will be placed in the same site used for the APBI~     device and no additional surgery will be performed. The drain will remain for 2-3 days and it~     will be removed by the patient at home. They will return for their routine follow-up~     appointments and be monitored for development of a seroma with the use of standard ultrasound~     and physical exam. Hypothesis: Based on the null hypothesis there will be no difference in~     the rate of seroma formation after the APBI device removal if a drain is placed.~   "
89882|NCT02390648|"~     Breast cancer patient receiving AC regimen chemotherapy (Doxorubicin + Cyclophosphamide) who~     has nausea score from 40/100 VAS or vomiting after the first or second cycle of chemotherapy~     is recruited. The patient who meets the eligibility criteria and provides informed consent is~     randomised to receive either Ginger capsule (500 mg) or placebo taking twice a day by mouth~     during the first 5 days of chemotherapy cycle. The study drug will be switched on the~     subsequent cycle (i.e. the patient who received Ginger capsule will receive placebo and vice~     versa). The primary outcome is the nausea score and vomiting during the first 5 days of each~     chemotherapy cycle when receiving the study drug.~   "
89883|NCT02390635|"~     The goal of this clinical research study is to learn if positron emission tomography/magnetic~     resonance imaging (PET/MRI), positron emission tomography/computed tomography (PET/CT) and~     whole body magnetic resonance imaging (MRI) can be used to detect extramedullary myeloid~     leukemia (EML). EML is a type of cancer found outside of the bone marrow and can be hard to~     detect with routine bone marrow monitoring, such as bone marrow aspirations.~      This is an investigational study. The PET/MRI and PET/CT scans on this study are performed~     using FDA-approved and commercially available methods. Using these scans to detect EML is~     considered investigational.~      Up to 55 participants will be enrolled on this study. All will take part at MD Anderson..~   "
89884|NCT02390622|"~     Methicillin-resistant Staphylococcus aureus (MRSA) is one of the major sources of nosocomial~     infection. Along with the widely application of antibiotics around perioperative period, MRSA~     infection is increasing by years.Fecal microbial transplantation (FMT),infusion of fecal~     preparation from a healthy donor into the GI tract of a patient is being proposed as a novel~     therapeutic approach to modulate diseases associated with pathological imbalances within the~     resident microbiota, termed dysbiosis.It has been used to treat intestinal disease such as~     inflammatory bowel diseases and Clostridium difficile infection, but no reports are available~     on its role in treating MRSA enteritis yet. vancomycin is the first choice to treat MRSA but~     can also lead to an increase in antibiotic resistant organisms such as vancomycin-resistant~     enterococci, methicillin-resistant Staphylococcus aureus and transfer of antibiotic~     resistance genes among the microbial community. So FMT seems a more harmless and reasonable~     measure to treat similar diseases.~   "
92013|NCT02362763|"~     Randomized controlled trial designed to determine whether acupuncture is an effective~     treatment for vestibulitis.~   "
89889|NCT02390557|"~     No standard way exists to measure the quality of medical care or independent living long-term~     services and supports provided to persons with disabilities. This project will: provide a~     broader picture of how consumers with disabilities define care and care quality; measure the~     value of using consumers' expertise in developing, collecting, and assessing quality~     measures; and use this information to assist One Care providers in improving care delivered~     to their enrollees~   "
89890|NCT02390544|"~     The purpose of this study is to examine the pharmacokinetics (PK) of melphalan in children~     undergoing hematopoietic stem cell transplantation (HSCT). Melphalan is an important~     component of HSCT preparative regimens, but can be associated with significant toxicity. PK~     data is a powerful clinical tool that, when used to develop individualized treatment plans~     for a specific patient, may ultimately increase the likelihood of selecting the right dose~     for the right patient and/or of reducing the number of adverse drug events. The~     investigators' goal is to establish baseline pediatric melphalan PK data. These data may be~     used for patient specific dosing of melphalan in the future to minimize toxicity and improve~     transplant outcomes.~   "
89891|NCT02390531|"~     The purpose of this study is to find a dose of intravitreal bevacizumab that is lower than~     currently used for severe retinopathy of prematurity (ROP), is effective in this study, and~     can be tested in future larger studies.~   "
89892|NCT02390518|"~     This is a Phase I dose escalation trial. The purpose of this study is to determine the~     maximum tolerated dose of radiation received during stereotactic radiosurgery in patients~     with brain metastases who have never received radiation to the brain before.~   "
89893|NCT02390505|"~     Vitamin C with its antioxidant role has many indications. The objective of this study is to~     demonstrate that taking vitamin C as a preventive significantly reduces the occurrence of~     complex regional pain syndrome (CRPS) type 1 in the aftermath of a scheduled surgery of the~     upper limb.~   "
89894|NCT02390492|"~     This 2-period, open-label, nonrandomized study will be conducted to determine the absolute~     bioavailability as well as the absorption, metabolism, and excretion of ipatasertib and its~     metabolite(s). Healthy male participants will receive a single 200-mg oral dose of~     ipatasertib followed 1 hour later by an 80-mcg/800-nCi intravenous dose of [14C]-ipatasertib.~     After a 4-day observation period and 10-day washout, participants will receive a single~     200-mg/100-mcCi oral dose of [14C]-ipatasertib with subsequent data collection for an~     additional 7 to 14 days until discharge criteria are met.~   "
89895|NCT02390479|"~     The primary objective of this case-control intervention study to explore the effectiveness of~     non surgical periodontal therapy on the gingival crevicular fluid (GCF) levels of sclerostin~     in patients with chronic periodontitis (CP) so as to get a more detailed insight into its~     diagnostic and prognostic potential as a biomarker of periodontal disease.~   "
89896|NCT02390466|"~     The purpose of this study is to evaluate the safety and tolerability of VAC-3S in controlled~     HIV patients receiving standard of care antiretroviral treatment.~   "
89897|NCT02390453|"~     This is a randomized controlled trial (RCT) of the effectiveness of cognitive and exercise~     training versus control condition on executive cognitive function in older adults with mild~     cognitive impairment (MCI).~   "
89898|NCT02390440|"~     This study is looking at a novel therapy of numbing medication injected directly around the~     fracture site. The purpose of this study is to determine if the study medication, EXPAREL®,~     is a viable alternative to current therapies for rib fractures.~   "
89899|NCT02390427|"~     This research study is a way of gaining new knowledge about the combination of Taselisib with~     other drugs in the treatment of metastatic breast cancer. Taselisib is an investigational~     drug which works by blocking a protein called PI3K (phosphoinositide 3-kinase) that helps~     cancer cells grow. This drug has been used in laboratory experiments and information from~     these studies suggests that this drug may help to prevent or slow the growth of cancer cells.~     The main purpose of this study is to find the appropriate dose of Taselisib to be used with~     other drugs in further clinical studies. This is an open-label, 3+3 dose-escalation phase Ib~     study to identify the Maximum Tolerated Dose(s) (MTD) and to identify the recommended phase 2~     dose (RP2D) of Taselisib. This study will be conducted in 4 separate arms. (A-D).~   "
89900|NCT02390414|"~     The purpose of this observational study is to compare overall survival in older adults with~     myelodysplastic syndromes (MDS) who receive reduced intensity conditioning hematopoietic stem~     cell transplant (RIC HSCT) versus those who do not receive HSCT.~   "
89901|NCT02390401|"~     To study if incisional vacuum-assisted closure can decrease the risk of infection in cesarean~     section incisions in the obese compared with standard sterile dressing.~   "
89902|NCT02390388|"~     The aim of this prospective randomized study is to assess the analgesic efficacy and duration~     of Pudendal block compared with Caudal block for pediatric patients undergoing hypospadias~     surgery concerning intraoperative analgesic and also postoperative total analgesic~     consumption within 24 hours.~   "
89903|NCT02390375|"~     The purpose of this study is to evaluate the efficacy and safety of the DW0929 in patients~     with primary hypercholesterolemia~   "
89904|NCT02390362|"~     We hypothesize that the anti-CD20 monoclonal antibody Rituximab will be more effective than~     MMF in maintaining remission in children with frequent relapsing or steroid dependent~     nephrotic syndrome who have had one relapse while receiving MMF.~      We will conduct a randomized study comparing two Rituximab infusions and continued MMF~     treatment. We plan to enroll 64 to have a comparater group of 58 (29 in each arm).~   "
89905|NCT02390349|"~     This randomized, placebo-controlled study evaluates the effects of CuraMed ® (BCM-95 ®) and~     Curamin ® in the treatment of osteoarthritis. One group will receive CuraMed, one group will~     receive Curamin and one group will receive placebo.~   "
89906|NCT02390336|"~     The concept of mobilization with movement, also referred to as a Mulligan mobilization, has~     not been studied in patients with hip osteoarthritis, subsisting questions about the possible~     effects in this population. The aim of this randomized controlled study is to compare the~     immediate effects of Mulligan mobilization with movement technique of pain, range of motion~     and physical function in patients with osteoarthritis of the hip.~   "
89920|NCT02390154|"~     The purpose of this trial is to investigate the fate of the roniciclib (study drug) in the~     body in a so called mass-balance study. This means to investigate how the study drug is~     absorbed, distributed, broken down (metabolized) and removed (excreted or eliminated) from~     the body.~   "
89907|NCT02390323|"~     This study is intended to evaluate a monitor that will facilitate ascertainment of an~     effective sympathetic blockade following Lumbar Sympathetic blocks. Utilization of a monitor~     with a rapid response and easy clinical applicability which can demonstrate effective~     sympathetic block would increase efficiency within the procedure suite and also serve to~     function as an objective endpoint for the evaluation of sympathetic blockade in future~     research.In current clinical practice, the most commonly used monitoring methods are clinical~     observations of sympathetic blockade, skin temperature monitoring, pulse pressure monitoring~     and any combination of these monitoring methods. The skin temperature and pulse pressure may~     increase after sympathetic block. However, changes in the skin temperature and pulse pressure~     often demonstrate an unpredictable or delayed response. Confounding variables, such as~     ambient temperature, coexisting vascular disease, use of other vasoactive medications may~     contribute to inconsistencies in the temperature or pulse pressure responses.~      Normal sympathetic activity stimulates muscarinic receptors in the periphery that~     subsequently stimulate the sweat glands to secrete and fill with sweat containing sodium and~     other electrolytes. The electrolytes present in the sweat increase the electrical conductance~     while decreasing the electrical resistance at the skin level.~      The real-time changes in skin conductance indices can be monitored at the skin level, by use~     of non-invasive electrodes attached to the skin (similar to EKG electrodes). A computer~     program analyzes the data and produces a real-time graphic and numeric data demonstrating the~     skin conductance response. The initiation of successful sympathetic blockade can cause rapid~     cessation of the skin sympathetic activity that leads to a decrease in skin conductance~     within seconds.~   "
89908|NCT02390310|"~     This is a research study in Kenya that will examine the outcomes of participants aged 10-15~     and 16 and older; and provider acceptability of the Shang Ring technique for male~     circumcision that would simplify use. The study will be in two phases:~      Phase 1 will explore the no-flip technique that has been used in China but will be used for~     the first time in Africa.~      Phase 2 will be a randomized trial comparing use of tropical vs. injectable anesthesia.~   "
89909|NCT02390297|"~     Long term safety follow-up of Cal-1 recipients~   "
89910|NCT02390284|"~     Glaucoma is a progressive disease resulting in blindness. Determining the onset of the~     disease, predicting its severity and the benefit of pressure lowering eye drops is key to~     clinical management aimed at maintaining useful vision with advancing age. This study will~     longitudinally monitor a population of glaucoma suspects (with positive factors for the~     disease but with normal vision) with noninvasive pattern electroretinogram (PERG) and other~     standard eye tests for glaucoma. The PERG measures the function of retinal ganglion cells~     (RGCs) that are the parent neurons of the optic nerve. RGCs may become dysfunctional before~     dying and their function restored with pressure-lowering eye drops. Glaucoma suspects with~     abnormal PERG will be randomized to treatment with eye drops, while those with normal PERG~     will be left untreated. All patients will be monitored with PERG, Optic Coherence Tomography~     (OCT) and other ancillary tests every 6 months over 4 years.~   "
89911|NCT02390271|"~     Introduction: Health care that addresses the emotional regulation capacity of patients with~     schizophrenia confronted with daily stress may contribute to a less anxious life. A~     psycho-physiological training (cardiac coherence training; CCT) focusing on emotion~     regulation is known to decrease anxiety for non-clinical individuals.~      Methods: the investigators performed a pilot cross sectional survey to explore the benefits~     of CCT for clinically stable patients with schizophrenia. Ten patients were enrolled in the~     program consisting in height to twelve weekly one hour session program during a 2-month~     follow-up. Standardised questionnaires were used before and after the intervention assessing~     anxiety, well-being outcomes, and how patients deal with stress and stressors.~   "
89912|NCT02390258|"~     This study is an evaluation of the safety and tolerability of XEN-D0103 in healthy subjects.~     Part 1 assesses the safety, tolerability and blood levels of the ascending single doses of~     XEN-D0103. Blood levels of XEN-D0103 will be assessed when administered with food and also~     without food in Part 2. The safety, tolerability and blood levels of XEN-D0103 will be~     assessed following dosing for 10 days in Part 3.~   "
89913|NCT02390245|"~     Our goal is to conduct a 5-year prospective, randomized controlled trial to test an~     innovative, community-based intervention using posterior and anterior fundus photography of~     the optic nerve and macular images to improve access and utilization of eye care to detect,~     treat, and manage high-risk patients with previously undiagnosed glaucoma and other eye~     diseases. Research shows that subject failure to attend follow-up eye care appointments~     diminishes any previous benefits of community screenings for glaucoma. Greater adherence to~     follow-up visits can reduce glaucomatous blindness.~   "
89914|NCT02390232|"~     In a population of patients with Non Alcoholic Fatty Liver Disease (NAFLD), the investigators~     will compare the composition of the gut microbiota from patients with simple steatosis with~     that with steatohepatitis.~      The purpose of this study is to determine if the pathogenic Escherichia Coli to the B2 group~     and producing the genotoxin colibactin is a factor for developing NASH.~   "
89915|NCT02390219|"~     The purpose of this study is to evaluate the safety and tolerability of LUM/IVA combination~     therapy in subjects 12 years and older with CF and advanced lung disease and who are~     homozygous for the F508del CFTR mutation~   "
89916|NCT02390206|"~     The purpose of this study is to document the effectiveness of treating chronic post-stroke~     spastic patients with Botulinum Toxin type A.~   "
89917|NCT02390193|"~     Introduction: Currently, chronic kidney disease (CKD) is one of the most serious public~     health problems, becoming a global epidemic. It is also known that the amount of displacement~     of overnight rostral fluid, from the lower limbs, is related to increased neck circumference~     and severity of obstructive sleep apnea (OSA) in patients with end-stage renal disease.~     Method / Design: A clinical trial study aiming to assess the degree of collapsibility of the~     upper airway in patients with CKD undergoing hemodialysis has been proposed. The test of the~     negative expiratory pressure and nocturnal polysomnography will be performed before and after~     the hemodialysis session. Discussion: The incidence of CKD has increased, due to the~     increased number of cases of diabetes mellitus and hypertension. Our hypothesis is that the~     weight gain due to volume overload, observed in the interdialytic period, will exert a~     negative influence on the degree of collapsibility of the upper airways predispose to OSA in~     CKD patients.~   "
89918|NCT02390180|"~     Recent research indicates that fatty acids in food may have a taste. There is no lexicon to~     describe the sensation of the fatty acids, but participants frequently describe the sensation~     as bitter or sour. The proposed study will ask participants who have been screened for their~     ability to detect fatty acids to sort a variety of taste stimuli, including sweet, sour,~     salty, bitter, umami, and fatty acid tastes. Observing how the participants sort the stimuli~     will allow us to determine if the fatty acid taste is unique from other taste sensations.~   "
89919|NCT02390167|"~     The purpose of this study was to determine if untrained subjects with diabetes and without~     diabetes could operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain~     valid glucose results.~   "
89923|NCT02390115|"~     The stroke is the second cause of death and the first of disabilities in the world. Although~     a motor spontaneous recovery is observed, around 50 to 70% of the hemiparetic upper extremity~     present alterations of upper extremity, limiting the performance of daily activities even~     after 2 to 4 years of strokes. More recently used in neurological rehabilitation, the ability~     to promote sensory-motor facilitation is given to the Elastic Tape (ET). However, its safety~     and efficacy in the treatment of post-stroke individuals still require further investigation.~     Thus, the objective of this project is to evaluate the immediate effects of ET, applied to~     the paretic shoulder on proprioception during movements of abduction and flexion of the~     shoulder and muscle activation and kinematic variables for the reaching in chronic~     hemiparetic. Fifteen subjects with chronic hemiparesis will participate these crossover~     sham-controlled trial. Participants will be randomized into two condition: elastic tape (ET)~     followed by sham tape (ST- strapping) or ST followed by ET. One month of washout period was~     considered. The motor impairment and the dominance before stroke will be evaluated by~     Fugl-Meyer scale and the Inventory Side dominance of Edinburgh, respectively. ET will apply~     deltoid (anterior, middle and posterior). Assessment before and after the application of ET~     will be performed. For proprioception assessment (joint position sense) will be evaluated~     using a dynamometer. Absolute error for shoulder abduction and flexion at the 30° and 60° was~     calculated. For the assessment of motor performance in a functional task (reach a glass of~     water), spatio-temporal parameters (total duration of the motion, peak velocity, time to peak~     velocity) and three-dimensional joint kinematics of the trunk, scapula, shoulder, and elbow~     (total range of motion, joint angle maximum and minimum) will be used. Concomitantly,~     bilateral activation of the deltoid (anterior, middle and posterior), trapezius (upper and~     lower), serratus anterior and pectoral major will be assessed by electromyography during~     reach. The following electromyographic variables will be analyzed: activation amplitude,~     muscle onset and maximum and minimum activation. For statistical analysis, the normality and~     homogeneity tests will be applied. If the variables have a distribution considered normal and~     homogeneous, Two-way ANOVA with repeated measures gift will be applied. Otherwise it will be~     applied to non-parametric statistics Friedman. Will be considered a 0.05 significance level~     for all statistical tests.~   "
89924|NCT02390102|"~     The objective of the study is to evaluate the efficacy of Erythropoietin (EPO) (+ iron) in~     reducing the rate of red blood cell transfusion requirements in patients with aortic stenosis~     undergoing transcatheter aortic valve replacement.~   "
89925|NCT02390089|"~     Aspiration pneumonia (APn) occurs at a higher rate in patients with Parkinson's disease (PD)~     versus healthy adults. This is of particular public health concern given that death secondary~     to aspiration pneumonia and lung infection is a leading cause of death in persons with PD.~     Swallowing and cough function are affected in PD, putting people with PD at significant risk~     for uncompensated aspiration (aspiration without adequate cough response). One challenge in~     the management of airway protective deficits related to PD is the chronic and progressive~     nature of the disease, where swallowing dysfunction appears subtly in the form of~     microaspiration, reducing the perceived urgency of the swallowing disorder by both clinicians~     and patients. The long-term goal of this research is to advance the management of airway~     protection deficits in patients with neurodegenerative disease in order to decrease morbidity~     and mortality due to aspiration related lung infection. The objective here is to further~     specify deficits leading to uncompensated airway compromise in PD in order to advance the~     clinical management of these patients, leading to an immediate positive impact.~   "
89926|NCT02390076|"~     The goal of this project is to use low-level light therapy (LLLT) to enhance neural~     metabolism in the prefrontal cortex of humans, and measure the effects of LLLT on attentional~     bias change following a single session of attention bias modification (ABM). LLLT is~     non-invasive, therapeutically beneficial, and promotes a wide range of biological effects~     including enhancement of energy production, gene expression and prevention of cell death.~     Previous research has indicated that human participants show a beneficial psychological~     effect, including improved mood and greater sustained attention, following a single treatment~     of LLLT to the forehead. ABM is a computer-based cognitive task designed to decrease the~     mood-congruent negative attentional bias frequently observed in depressed and dysphoric~     individuals. Previous ABM studies have led to decrease in clinical symptoms relative to a~     control condition. This study will explore whether the effects of LLLT on mood and attention~     could improve the potency of ABM, leading to greater attention change and greater improvement~     of mood relative to sham LLLT.~   "
89927|NCT02390063|"~     This is a clinical trial of a new treatment for prostate cancer that is a type of vaccine~     that could be a new way to treat cancer. A vaccine that could alert the immune system to the~     presence of cancer cells in the body may enable the immune system to target and kill those~     cells effectively. This vaccine is intended to work by making the immune system kill cells~     that have a special protein (called 5T4) that is present on the surface of cancer cells. The~     vaccine is made up of two recombinant viruses (ChAdOx1 and MVA) that have been designed~     to produce the 5T4 protein and have been modified so that they are weakened and cannot~     reproduce themselves within the body like normal viruses. Once injected into the body, these~     viruses make the 5T4 protein and help the body's immune system to learn to target this~     protein and destroy cancer cells.~      This is a first-in-human study to evaluate the safety and immunogenicity of~     ChAdOx1.5T4-MVA.5T4 vaccination regime. It is evaluated in neo-adjuvant setting in low and~     intermediate risk localised prostate cancer patients who have either decided to have their~     prostate removed or are stable on active surveillance.~   "
89928|NCT02390050|"~     The purpose of this study is to investigate the effect of bexagliflozin in lowering~     hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM). Bexagliflozin~     is an orally administered drug for the treatment of T2DM and is classified as a Sodium~     Glucose co-Transporter 2 (SGLT2) Inhibitor. This study will enroll both treatment naive and~     those subjects previously treated with one oral hypoglycemic agent (OHA). Approximately 320~     subjects eligible for randomization will receive bexagliflozin tablets, 5, 10, 20 mg or~     placebo, once daily for 12 weeks in an outpatient setting.~   "
89929|NCT02390037|"~     The objective of the study is to assess the incidence of safety outcomes in patients treated~     with Pipeline™ Flex embolization device with Shield Technology™.~   "
89930|NCT02390024|"~     Mechanical ventilation (MV) is a vital support tool for critically ill patients. However, it~     may present several adverse effects, such as the development of cognitive and~     psychopathological alterations. Patient-ventilator asynchronies occur frequently since the~     beginning of the MV. These asynchronies are associated with poor clinical outcome and could~     be responsible for the neuronal changes causing these alterations. The objective of this~     project is to analyze the influence of patient-ventilation asynchronies in the development of~     long-term cognitive/psychopathological impairments and to explore the molecular mechanisms~     that could explain of these alterations. An exploratory, observational, multicenter,~     non-interventionist study will be performed in 150 ICU patients. The continuous recording of~     asynchronies and other clinical variables during ICU stay and the results of~     neuropsychological assessments will enable to identify clinical clusters associated with~     cognitive/psychopathological impairments.~   "
89931|NCT02390011|"~     This is a single center pilot study testing the use of novel coil arrays with MR liver~     imaging. In part A of the study, up to 30 healthy volunteers will be scanned, with iterative~     adjustment of coil array geometry and design to optimize imaging characterstics. In Part B of~     the study, 40 patients with advanced solid tumors and at least one liver metastasis measuring~     > 1.5 cm in diameter on standard anatomic scans will undergo MR liver imaging with the newly~     designed coil array, with the use of gadolinium contrast. Patients with liver tumors will~     have the option of undergoing a second MR liver scan during the course of subsequent systemic~     therapy.~   "
89932|NCT02389998|"~     This study is aimed at investigating the efficacy of placebo for symptom relief in children~     with abdominal pain related functional gastrointestinal disorders.~   "
89933|NCT02389985|"~     The purpose of this study is to estimate the maximum tolerated doses (MTD) of CRLX101 when~     administered in combination with weekly paclitaxel in women with recurrent or persistent,~     epithelial ovarian, fallopian tube or primary peritoneal cancer.~      Determine through pharmacokinetic evaluation(sometimes described as what the body does to a~     drug, refers to the movement of drug into, through and out of the body-the time and course of~     its absorption, bioavailability, distribution, metabolism, and excretion) whether or not the~     disposition of paclitaxel is affected by the concurrent administration of CRLX101.~   "
89934|NCT02389972|"~     The primary objective is to describe the effectiveness of dasatinib (Sprycel®) in CML~     patients in China in the real-world clinical practice setting.~   "
89935|NCT02389959|"~     This is a randomized, controlled, double-blind, placebo-controlled trial of intranasal~     Avastin (bevacizumab) injection versus saline control for control of HHT-related epistaxis~     when used in conjunction with bipolar electrocautery.~   "
89936|NCT02389946|"~     The objective of this study is to assess the safety and efficacy of the Orsiro Sirolimus~     Eluting Coronary Stent System in the treatment of subjects with up to three native de novo or~     restenotic (standard PTCA only) coronary artery lesions compared to the Xience coronary stent~     system.~   "
89937|NCT02389933|"~     Novartis has set up this global Multiple Patient Program (MPP) treatment plan to provide~     access to life-saving treatment with LCZ696 for patients that were not previously exposed to~     LCZ696 but have no other option to receive LCZ696 in their country prior to market~     authorization OR commercial availability, based on local regulatory and legal requirements.~   "
89938|NCT02389920|"~     Describe the purpose of the study: This study aims to evaluate the improvement of~     Dasatinib-related adverse events and to evaluate the treatment effect and safety by measuring~     the genetic response of nilotinib with nilotinib 400mg BID for 12 months in Philadelphia~     chromosome-positive chronic myeloid leukemia patients intolerant to Dasatinib.~   "
89939|NCT02389907|"~     Assessing the association between patients' perceptions of success with post-operative pain~     management and overall experience with care.~   "
89940|NCT02389894|"~     To evaluate the efficacy and safety of embolic protection devices to reduce ischemic brain~     injury in patients undergoing surgical aortic valve replacement (AVR).~   "
89941|NCT02389881|"~     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of~     multiple doses of TAK-058 in healthy non-elderly and elderly participants.~   "
89942|NCT02389868|"~     The purpose of this study is to evaluate the effects induced by the cholesterol-reducing drug~     Lovastatin on the platelet proteome of healthy volunteers. Our results may allow to recognize~     the cell signalling modifications induced by Lovastatin. Furthermore, the current study aims~     to characterize the biological and inter-individual variation of platelet's proteome as~     measured by liquid chromatography-tandem mass spectrometry. Lastly, the exploration of~     changes induced by Lovastatin on the platelet's proteome may allow the discovery of~     modifications relative to the effects of statins on hemostasis and the lipid profile.~   "
89943|NCT02389855|"~     The NeuroBlate® System (NBS), is a minimally invasive robotic laser thermotherapy tool. It~     employs a pulsed surgical laser to deliver targeted energy to abnormal brain tissue caused by~     tumors and lesions. Since receiving FDA clearance in April 2013, the NBS has been used in~     nearly 300 procedures conducted at approximately 20 leading institutions across the United~     States. This post-market, multi-center retrospective study is designed to collect long-term~     follow-up data on patients who were treated previously with NBS.~   "
89944|NCT02389842|"~     Part A: This is a phase Ib trial combining the CDK4/6 inhibitor palbociclib with the PI3K~     inhibitors taselisib, or pictilisib. There are two treatment arms during the dose escalation~     phase where patients will receive either taselisib OR pictilisib in combination with~     palbociclib. Palbociclib, taselisib and pictilisib can all be given orally once daily with~     food, in a 21-days-on and 7-days-off schedule. Once the MTD is reached, the combination with~     the optimum safety and PK/PD profile will be taken forward to the dose expansion phase (Part~     B).~      Part B1: At the MTD dose expansion, fulvestrant will be administered in addition to~     palbociclib and taselisib or pictilisib orally once daily, in a 21-days-on and 7-days-off~     schedule in the ER+ve HER2-ve PIK3CA mutant breast cancer cohort. Fulvestrant will be given~     intramuscularly on Day 1, Day 15 in cycle one followed by Day 1 for all subsequent cycles.~      Part B2: At the MTD dose expansion, patients with PIK3CA mutant advanced solid tumours will~     be treated with palbociclib and taselisib or pictilisib orally once daily, in a 21-days-on~     and 7-days-off schedule.~   "
89945|NCT02389829|"~     Opioids are commonly used to treat migraine in North American Emergency Departments. We are~     comparing efficacy and adverse events of hydromorphone, an opioid, to that of~     prochlorperazine, a dopamine antagonist with known efficacy in migraine. Prochlorperazine~     will be combined with diphenhydramine to prevent adverse events.~   "
89946|NCT02389816|"~     The purpose of this study is to evaluate the efficacy of two fixed doses of Lu AA21004 (10 or~     20 mg/day) after 8 weeks of treatment in patients with MDD in Japan~   "
89968|NCT02389530|"~     Fluorescein is a dye agent that can be injected through an intravenous line. It has been~     shown to help tell the difference between brain tumor tissue and normal brain tissue when it~     is used together with a specialized filter on a microscope in the operating room. The~     investigators plan to study the use of fluorescein in the removal of brain tumors at a low~     dose.~   "
91611|NCT02368067|"~     The purpose of this study is to compare the Instillation Technique Using The Modified Intra-~     Uterine Manipulator Catheter With Methylene Blue, Isosulfan Blue or Indocyanine Green Dyes,~     Compared to Cervical Injection, For Sentinel Lymph Node Detection in Endometrial Carcinoma.~   "
89947|NCT02389803|"~     Study design:~      Double blind, randomized, placebo controlled study. Participants will be randomly assigned~     either to the intervention group or the placebo control group. Randomization for the two~     study groups will be made in a ratio of 1:1.~      The primary objective of the study is to assess the effect of 6-12 months treatment with~     nutritional supplementation standardized formula, in short and lean boys adolescents on~     weight Standard Deviation Score (SDS) and height SDS The Secondary Objectives of the study~     are to assess the effect of 6-12 months treatment with nutritional supplementation~     standardized formula, in short and lean boys adolescents on BMI SDS, growth velocity, time to~     puberty, quality of life and self-esteem The study will continue for 6 months of intervention~     versus active placebo, with additional optional 6 months (an extension period), in which~     participants at both groups, the intervention and the placebo, will be offered to continue~     their participation in the study with the study supplement. All analyses of the effect's on~     primary and secondary outcome measurements will take into account the consumption rate of the~     study formula/placebo~   "
89948|NCT02389790|"~     The primary objectives of the study are:~      -To evaluate the long-term safety and tolerability of MT-1303 in subjects with moderate to~     severe active Crohn's Disease（CD）~   "
89949|NCT02389777|"~     This phase II clinical study will include fifteen healthy light skinned adult volunteers. At~     screening subjects will be given a sunburn test. This procedure involves exposing eight 1~     square cm areas of skin over increasing doses of simulated solar radiation (SSR). SSR is~     delivered by a 1,000-Watt xenon arc lamp, which emits ultraviolet wavelengths from 290-400~     nm, closely resembling natural sunlight. The Minimal Erythema Dose (MED) will be determined~     approximately 24 hours after initial exposure by using a chromometer. The MED is calculated~     by linear regression. Each test site is a one inch square area on the buttock or lower back.~     Sites 1, 2, 3, 4, 5 will be irradiated with 2 MED of SSR. Site 1 will not receive any ACCS~     treatment. Sites 2 and 3 will be treated with ACCS immediately after irradiation. 8-12 hours~     later or at bedtime, Sites 2,3,4,5 with ACCS at home. ACCS will also be applied 24 hours~     after SSR. Between 24-36 hours after SSR, subject returns to the Skin Study Center for~     Minolta chromometer assessment of erythema at all test sites, as well as for high resolution~     digital photography (Canfield). These assessments will be repeated at 48 hours and 72 hours~     post SSR. Data will be graphed to quantify rate of erythema resolution. Punch biopsies will~     be obtained at Site 1 (control) and Site 2 (SSR + immediate ACCS Rx). If a difference in~     erythema is observed between Site 1 and Site 4, a biopsy will also be obtained from Site 4~     (SSR + delayed ACCS Rx). Biopsy samples will be tested using Reverse Transcriptase~     -Polymerase Chain Reaction (RT-PCR) and/or immunohistochemistry for markers of UV~     inflammation such as Interleukin (IL)-6, Tumor Necrosis Factor (TNF) -alpha, etc. Subjects~     will continue to apply the ACCS twice daily on Sites 3 and 5 until study visit 5. An~     additional normal control skin biopsy may be performed in a subset of volunteers (4-5) to~     serve as reference control for the tissue analysis.~   "
89950|NCT02389764|"~     The goal of this clinical research study is to learn if Ofev® (nintedanib, also called~     BIBF1120) can help to control IBC. The safety of this drug will also be studied.~      This is an investigational study. Nintedanib is commercially available and FDA approved for~     the treatment of certain types of lung disease. Its use in this study is investigational. The~     study doctor can explain how the study drug is designed to work.~      Up to 44 participants will be enrolled in this study. All will take part at MD Anderson.~   "
89951|NCT02389751|"~     The goal of this clinical research study is to find the highest tolerable dose of ganetespib~     that can be given in combination with standard chemotherapy (paclitaxel and carboplatin) and~     radiation therapy in patients with esophageal cancer.~   "
89952|NCT02389738|"~     The blood-brain barrier (BBB) is an intricate barrier composed of a variety of efflux pumps,~     a luminal negative charge, a basal lamina and three distinct cell types: brain endothelial~     cells, pericytes, and astrocyte foot processes. Specifically, the BBB integrity and degree of~     permeability is regulated by the capillary endothelial cells in response to astrocytic~     signals. The strength of intercellular junctions (ex. tight junctions, adherins) amongst~     endothelial cells also plays a major role in permeability. Therefore, modulation of all these~     paracellular properties may decrease BBB integrity and thus improve drug penetration to the~     tumor bed. Previous studies utilizing the vasoactive peptide, Regadenoson, demonstrated~     transient increase in BBB permeability, allowing a 70kD dextran molecule to enter the brain~     of rodents. Thus, the investigators propose to evaluate brain interstitium concentrations of~     temozolomide pre and post Regadenoson using brain microdialysis. If Regadenoson successfully~     demonstrates effectiveness in disrupting the BBB, it could be of major importance in~     improving the outcome of patients with a variety of brain tumors and other neurologic~     illnesses.~   "
89953|NCT02389725|"~     What is the effect of two common tourniquet techniques on the first attempt success rate of~     peripheral intravenous cannulation?~   "
89954|NCT02389712|"~     The FLAME Study is a 16-week clinical trial to study treatment with lamotrigine or fluoxetine~     in bipolar I, II and bipolar schizoaffective depressed adults. The purpose of the trial is to~     have a better understanding of whether individuals with a particular gene type and other~     inherited biological markers will have a good response to fluoxetine or lamotrigine, or~     alternatively, would be more likely to have side effects to this medication.~   "
89955|NCT02389699|"~     Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation during~     surgery followed by external-beam radiation to the entire breast may kill more tumor~     cells.The clinical trial is conducting to compare the effectiveness of radiation therapy~     during surgery and whole-breast radiation therapy in treating women who have undergone~     breast-conversing surgery for Intermediate or high grade ductal carcinoma in situ breast~     cancer.~   "
89956|NCT02389686|"~     The role of NSM is still controversial, mainly because of concern about the oncologic safety~     of the nipple-areola complex (NAC).INTRABEAM (Carl Zeiss, Oberkochen, Germany) is the most~     widely used mobile intraoperative radiotherapy (IORT) device to date. This study aims to~     assess the value of the INTRABEAM system for breast cancer.~   "
89957|NCT02389673|"~     Whether the patients with low grade ductal carcinoma in situ breast cancer should accept~     radiationtherapy is uncertain.Radiation therapy uses high-energy x-rays to damage tumor~     cells. Giving radiation during surgery followed by external-beam radiation to the entire~     breast may kill more tumor cells.The clinical trial is conducting to find out the~     effectiveness of radiation therapy during surgery in treating women who have undergone~     breast-conversing surgery for low grade ductal carcinoma in situ breast cancer.~   "
90003|NCT02389075|"~     This study plans to learn more about the relationship between systemic autoimmune disease,~     such as inflammatory bowel disease and ankylosing spondyloarthritis, bacteria in the colon,~     and the changes in colon tissue.~   "
89958|NCT02389660|"~     Effective, accessible, and affordable depression treatment is of high importance considering~     the large individual and economic burden of depression. There is ample support for the~     effectiveness of Internet-based Cognitive Behavioral Therapy (CBT) for depression which is~     considered a promising alternative to routine depression treatment strategies. Most evidence~     comes from randomized controlled trials, however, and not from research in routine practice.~      The European Comparative Effectiveness Research on Internet-based Depression Treatment~     (E-COMPARED) in Poland aims to compare the clinical and cost-effectiveness of blended CBT for~     adults with major depressive disorder (MDD) with treatment as usual (TAU). The trial will be~     conducted in routine mental health care in Poland, and is a part of the bigger project funded~     by European Commission (Grant Agreement No: 603098). In this randomized controlled trial, a~     total of 150 patients with MDD will be assigned to one of two conditions: 1) blended CBT, 2)~     TAU. Respondents in both conditions will be followed until 12 months after baseline (measures~     will be taken at baseline, 3 months, 6 months and 12 months).~   "
89959|NCT02389647|"~     The purpose of this study is to use an iatrogenic model of stroke, meaning those strokes~     inadvertently caused by endovascular coiling of elective aneurysms, to study the biology of~     stroke in humans.~   "
89960|NCT02389634|"~     The purpose of the study is to identify novel genetic and protein markers for the process of~     cerebral vasospasm following aneurysmal subarachnoid hemorrhage.~   "
89961|NCT02389621|"~     The primary purpose of this study is to compare the efficacy of lusutrombopag with placebo~     for the treatment of thrombocytopenia in patients with chronic liver disease who are~     undergoing elective invasive procedures.~   "
89962|NCT02389608|"~     Background: Transcranial direct current stimulation (tDCS) is currently considered a~     beneficial method for patients with neurological problems due to the modulation of cortex~     activity as well as the enhancement and prolongation of functional gains achieved during~     physical therapy. Purpose: The aim of the proposed study is to evaluate the immediate effects~     of a session of tDCS over the primary motor cortex combined with functional electrical~     simulation (FES) on electrical activity of the tibialis anterior muscle, balance and~     distribution of plantar pressure in individuals with hemiparesis stemming from a stroke. A~     further aim is to determine whether the effects of the combination of both stimulation~     methods are better than those achieved when each method is employed alone. Methods/design: A~     randomized, double-blind, crossover, cross-sectional study will be conducted involving 30~     stroke survivors with hemiparesis who meet the eligibility criteria. Evaluations will involve~     an identification and screening chart, the classification of motor impairment using the~     Fugl-Meyer Scale, the determination of spasticity of the triceps surae muscle (modified~     Ashworth scale), electromyography of the tibialis anterior muscle, static balance and~     cognitive dual-task balance (stabilometry) and plantar pressure. After the initial~     evaluations, the participants will undergo four interventions: 1) anodal tDCS + placebo FES +~     active tibialis anterior contraction; 2) placebo tDCS + active FES + active tibialis anterior~     contraction; 3) anodal tDCS + active FES + active tibialis anterior contraction; and 4)~     placebo tDCS + placebo FES placebo + active tibialis anterior contraction. tDCS will be~     administered over the primary motor cortex and FES will be administered over the tibialis~     anterior muscle. The order of the different protocols will be randomized and both the~     evaluator and patients will be blinded to which protocol is being administered.~   "
89963|NCT02389595|"~     The purpose of this research study is to develop a vaccine against Human immunodeficiency~     virus (HIV), a disease that causes AIDS in people,. The investigator will be looking at~     viruses similar to HIV in animals. Since these viruses are very similar to HIV, the blood~     from humans who have been exposed to HIV will be tested to see if the immune system will~     recognize the HIV and prevent infection.~      HIV targets the immune system by attacking certain T cells called CD4+ T cells. There are~     parts on the AIDS viruses that help the virus infect these cells and other parts that help~     the immune system prevent viral infection by activating protective T-cells that fight HIV.~     Different T-cell populations are very important in most vaccines as they act as effectors~     that work as part of the immune system to recognize and fight off HIV infection. When~     effector T cells are activated by appropriate protective part(s) of the virus they either~     block HIV from reproducing or kill HIV infected cells. By finding these common protective~     parts of each of these human and animal AIDS viruses, the investigator hopes to make a~     vaccine that helps the immune system prevent HIV infection by avoiding parts that attack CD4+~     T cells and may worsen HIV infection and selecting for parts that stimulate effector T cells~     that fight HIV infection.~   "
89964|NCT02389582|"~     Anticoagulation with heparin is indicated in several situations, such as acute coronary~     disease (in combination with antiplatelet therapy) for the prevention and treatment of venous~     thromboembolism and situations with high risk of thromboembolism. Recently, the latest trials~     on anticoagulation for stroke prevention on atrial fibrillation have shown an increased risk~     for acute mycardial infarction on patients submitted to new oral anticoagulants, such as~     dabigatran. The mechanism is still unclear, however, in this context, some previous studies~     about interaction between anticoagulants ( mainly heparin) and platelet aggregation have~     shown conflicting results: while some suggest an inhibitory effect of heparin on platelet~     function, others suggest that heparin could promote an increase in platelet activation. The~     present study aims to assess the effects of the LMWH Enoxaparin and direct thrombin~     inhibitor, Dabigatran, on platelet aggregation, studied and compared by different methods in~     patients with chronic coronary artery disease (CAD).~   "
89965|NCT02389569|"~     This study aimed to evaluate the clinical performance of a novel vitro-ceramic biomaterial~     (Biosilicate®) as treatment of caries-affected dentin in posterior resin restorations. A~     total of 94 restorations of 66 participants were selected and assigned at random into four~     groups: 1 (Biosilicate / Two-step etch and rinse system), 2 (Control / Two-step etch and~     rinse system), 3 (Biosilicate / Two-step self-etching system) and 4 (Control / Two-step~     self-etching system). Two operators carried out the adhesive protocols and restored the~     cavities with a nano-hybrid resin composite (IPS Empress, Ivoclar) using the incremental~     technique. Participants were recalled at one week, 6, 12 and 18 months for clinical~     evaluation performed by two blinders and calibrated examiners according FDI criteria.~   "
89966|NCT02389556|"~     ANGPTL3 and ANGPTL8 are emerging molecules involving lipid metabolism. In previous in vivo~     study using mice, ANGPTL8 regulated the activation of ANGPTL3 which was known to inhibit~     lipoprotein lipase activity and stimulate lipolysis of adipose tissue. Besides, glypican 4~     was identified as a novel adipokine modulating adipocyte differentiation. Thus, the~     investigators postulated that different serum concentrations of ANGPTL3, ANGPTL8 and glypican~     4 might affect progression of obesity in children. The investigators measure these molecules~     in Korean children, and investigate the association between these molecules and development~     of obesity.~   "
89967|NCT02389543|"~     This is an open-label, randomized clinical study with two stages to assess the maximum~     tolerated dose (MTD), efficacy, and safety of selinexor, lenalidomide, and dexamethasone~     (SLd) in patients with relapsed/refractory (RR) multiple myeloma (MM). The stages are dose~     escalation (Phase 1) and expansion (Phase 2).~   "
89969|NCT02389517|"~     This randomized phase II trial studies how well lenalidomide alone compared to lenalidomide,~     ixazomib citrate, and dexamethasone work in treating patients with multiple myeloma that~     remains (residual) after donor stem cell transplant. Lenalidomide may help the immune system~     kill abnormal blood cells or cancer cells and may also prevent the growth of new blood~     vessels that are needed for cancer growth. Ixazomib citrate may stop the growth of cancer~     cells by interfering with proteins necessary for cell growth. Drugs used in chemotherapy,~     such as dexamethasone, work in different ways to stop the growth of cancer cells, either by~     killing the cells, by stopping them from dividing, or by stopping them from spreading. It is~     not yet known whether lenalidomide is more effective with or without ixazomib citrate and~     dexamethasone in treating residual multiple myeloma.~   "
89970|NCT02389504|"~     An Investigation of Return to Play Exertion Protocol in Concussed Adolescents~   "
89971|NCT02389491|"~     The purpose of this study is to explore the effects of high density formula in early~     postoperative infants with congenital heart disease and to assess its safety.~   "
89972|NCT02389478|"~     The purpose of this study is to explore the effects of Oropharyngeal administration of~     colostrum to very low birth weight infants on sIgA and lactoferrin, in order to explore the~     protect immune function of colostrum to very low birth weight infants, to improve the~     utilization of breast milk and reduce infection rates of very low birth weight infants.~   "
89973|NCT02389465|"~     Over 18% of Americans aged 65 years and older have depression. Recent evidence suggests that~     there is a link between depression and inflammatory disease. This study investigates the~     relationship between inflammation in the brain and depression. Comparing biological and~     psychological differences in depressed and non-depressed people allows researchers to find~     better ways to treat and prevent depression. All participants will have: neuropsychological~     tests, an EKG, a spinal tap, a blood draw, and, if depressed, given either an antidepressant~     coupled with an anti-inflammatory medication or an anti-depressant coupled with a placebo for~     six weeks. The investigators are trying to correlate brain function with depression levels~     and biomarkers from the blood and spinal fluid.~   "
89974|NCT02389452|"~     Primary Objective:~      To evaluate the safety and efficacy of a single 6 mL intraarticular (IA) injection of~     Synvisc-One in participants in India with symptomatic osteoarthritis (OA) of the knee(s).~      Secondary Objective:~      To evaluate the safety and short-term efficacy of a repeat treatment with Synvisc-One.~   "
89975|NCT02389439|"~     This study is a prospective, single arm, open-labelled clinical trial. The total number~     subjects will be 145 patients to receive Pyronaridine-artesunate once daily for 3 days.~     Dosing will be according to the body weight.~      All patients will have a blood smear examined daily during the first week by microscopy until~     parasite clearance (2 consecutive negative slides on two consecutive days; both asexual and~     sexual stages). A negative blood slide will be defined as parasite count negative per 1000~     WBC in two consecutive days. The sample on day 3 will be taken as close as possible to 72h~     after the initial blood smear.~      Participant will follow up for 42 days to assess the drug efficacy and safety (Day 7, 14, 21,~     28, 35 and 42).~   "
89976|NCT02389426|"~     The aim of this study is to investigate the potential of Transcranial doppler (TCD) and~     Near-Infrared Spectroscopy (NIRS), more simple and non-invasive bedside methods than magnetic~     resonance imaging (MRI), to evaluate changes in the cerebral circulation between patients~     with MS and control subjects.~   "
89977|NCT02389413|"~     The aim of this study is to evaluate the safety, tolerability and preliminary efficacy of~     PQ912 in subjects with Mild Cognitive Impairment (MCI) due to Alzheimers Disease (AD) or mild~     dementia due to AD.~   "
89978|NCT02389400|"~     Study Type: Interventional~      Study Design:~      Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking:~     Open Label Primary Purpose: Treatment purpose: This single arm clinical trial is studying~     efficacy and tolerance of combination chemotherapy with methotrexate and cytosine arabinoside~     in newly diagnosed adult with Langerhans cell histiocytosis.~   "
89979|NCT02389387|"~     The purpose of this study is to facilitate coordination of transplant centers in North~     Carolina, South Carolina, and Georgia to share kidney transplant referral data in patients~     with End-Stage Renal Disease (ESRD) who are candidates for kidney transplantation.~   "
89980|NCT02389374|"~     This is a study assessing safety and efficacy of current national guidelines for the~     treatment of uncomplicated malaria in Bangladesh as well as to assess the G6PD status among~     the enrolled patients.~   "
89981|NCT02389361|"~     Comparison of two different regimens of analgesia after inguinal hernia repair. First, is a~     classical intravenous protocol with paracetamol and tramadol. Second is an oral protocol with~     Zaldiar (combination of paracetamol and tramadol).~   "
89982|NCT02389348|"~     This is a single-centre, open-label, dose finding study using induced blood stage malaria~     (IBSM) infection to characterize the pharmacodynamic interaction between OZ439 and DSM265,~     administered around 120 minutes apart for treatment of early Plasmodium falciparum blood~     stage infection. The study will be conducted in up to three cohorts (n=8 per cohort) using~     different doses of OZ439 and DSM265. The doses of OZ439 and DSM265 that will be investigated~     in the first cohort will be 200 mg of OZ439 and 100mg of DSM265, both administered as single~     doses around 120 minutes apart. Subsequent doses in subsequent cohort(s) will be determined~     following a review of observed OZ439 and DSM265 safety, and pharmacokinetic and~     pharmacodynamic interaction outcomes, particularly the antimalarial activity of the drugs~     given in combination as defined by parasite clearance kinetics. The doses used in Cohort 2~     and 3 may be adjusted but will not exceed the maximum acceptable doses predefined for this~     study (which are 400 mg for DSM265 and 500mg for OZ439) as determined in previous safety and~     pilot efficacy studies. The dose will be determined by the funding sponsor and the principal~     investigator (PI) following Safety Review team (SRT) and scientific evaluation. If no safe~     alternative dose can be determined the option exists to curtail the study to less than three~     cohorts.~      Each participant in the cohort will be inoculated on Day 0 with ~1,800 viable parasites of~     Plasmodium falciparum-infected human erythrocytes (BSPC) administered intravenously. On an~     outpatient basis, participants will be monitored daily via phone call and then daily (AM)~     from day 4 (until PCR positive for presence of malaria parasites). Once PCR positive they~     will be monitored twice-daily morning (AM) and evening (PM) until treatment, for adverse~     events and the unexpected early onset of symptoms, signs or parasitological evidence of~     malaria. On the day designated for commencement of treatment, as determined by qPCR results,~     participants will be admitted to the study unit and monitored. The threshold for commencement~     of treatment will be when PCR quantification of all participants is = 1,000 parasites/mL. If~     the PCR quantification of any participant is = 5,000 parasites/mL and is accompanied by a~     clinical symptom score >5, or if clinical or parasitological evidence of malaria occurs in~     any participant before all participants have reached the treatment threshold (PCR~     quantification of = 1,000), then treatment of that participant will begin within a 24 h~     period.~      Following treatment with OZ439 and DSM265, participants will be followed up as inpatients for~     at least 48 hours to ensure tolerance of the treatment and clinical response, then if~     clinically well on an outpatient basis for safety and clearance of malaria parasites via PCR.~      Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) will occur on~     study day 16 ±3 days post OZ439 and DSM265 treatment unless required earlier. Early standard~     anti-malarial drug intervention can occur if either poor responses or fast responses are seen~     following OZ439 and DSM265 treatment. This is to ensure participant safety and to avoid~     participant inconvenience if useful data cannot be obtained. A poor response is defined as a~     decrease in parasitaemia of less than 20% from baseline by 3 days post OZ439 and DSM265~     treatment. A fast response occurs when, within the seven day period following the treatment,~     two consecutive PCR assessments in 48 hours are negative. However, pre-emptive treatment with~     Riamet® can commence whenever deemed necessary by the investigator. Participants will be~     monitored, either in clinic, or by telephone for three days to ensure adherence to Riamet®~     therapy.~      Participants will be treated with a single dose (45 mg) of primaquine as described in section~     4.3 in this protocol at the end of their Riamet® treatment if gametocytes are identified, to~     ensure complete clearance of any gametocytes present.~      Adverse events will be monitored via telephone monitoring, within the clinical research unit,~     and on outpatient review after malaria challenge inoculation and antimalarial study drugs~     administration. Blood samples for safety evaluation, malaria monitoring, and red blood cell~     antibodies will be drawn at screening and/ or baseline and at nominated times after malaria~     challenge.~   "
89983|NCT02389335|"~     The mechanism of β cell destruction in Type 1 diabetes is not exactly known, Our hyphotesis~     is that interferon gamma, interleukin-2 and tumor necrotizan factor alpha have impotant roles~     in β cell destruction.~   "
89984|NCT02389322|"~     The investigators select 500 subjects who meet the standard and are considered as study~     population I. Do specific gamma-interferon detection before the skin test， then inject~     intradermally with two dosage ESAT6-CFP10 and Tuberculin purified protein derivative (TB-PPD)~     at different arm of the same subject and get 192 participants whose three kinds of detection~     result are all negative and are considered as study population II.Then,they are immune to the~     Bacillus Calmette-Guerin (BCG) vaccine or the placebo of the BCG. Do specific~     gamma-interferon detection before the skin test， then inject intradermally with two dosage~     ESAT6-CFP10 and TB-PPD at different arm of the same subject 12 weeks after immunity.Negative~     rate of ESAT6-CFP10 after vaccination BCG as the main index , evaluate the specificity of~     different doses of ESAT6-CFP10, and conform the optimal dose of ESAT6-CFP10.~   "
89985|NCT02389309|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of dasatinib, cyclophosphamide, and temsirolimus that can be given to patients~     with advanced solid tumors. The safety of this drug combination will be studied. As secondary~     aim the study will evaluate treatment response to this combination and biological markers.~   "
89986|NCT02389296|"~     The aim of this study is to determine whether the work environment influences the role~     perception of nurses in psychiatric wards. This will be a comparative study. Questionnaires~     will be distributed to nurses working in psychiatric wards in 10 medical centers in Israel.~   "
89987|NCT02389283|"~     Rheumatoid arthritis (RA) is a chronic inflammatory disease characterized by intra and~     peri-articular synovial inflammation. Synovitis can damage the articular cartilage, bones,~     joint capsule, tendons and ligaments leading to the consequential functional joint~     deterioration.~      The main goal of RA treatment is to achieve disease remission. The treatment of RA consists~     of synthetic and biologic disease modifying drugs (DMARDs), being the second ones selected~     when low disease or remission is not achieved with the first ones. Therapeutic response~     monitoring in RA should be closely managed. It is classically based on clinical exploration~     and laboratory tests. During the last decade, the resolution improvement of musculoskeletal~     ultrasound (MSUS) imaging has led to the gradual incorporation of this technique in the~     evaluation and monitoring of patients with RA, mainly due to its better capacity to detect~     synovitis than clinical exploration . Ultrasound imaging is highly available, non-invasive,~     reproducible, affordable and well accepted by patients. Ultrasound doppler mode detects~     pathological synovial flow, which reflects synovial inflammation and has a demonstrated~     sensitivity to change in multiple longitudinal studies. Sonographic evaluation of patients~     with RA includes the detection of synovitis in B and Doppler mode in the joints accessible by~     ultrasound. There has been high variability in the literature regarding the number of joints~     that should be evaluated for an appropriate monitoring of the RA patients. The validity for~     monitoring the therapeutic response in long standing RA has been demonstrated in three~     reduced joint counts, including 12, 7 and 6 joints. However, in shorter evolution RA, the~     sensitivity to change of any of these reduced ultrasound evaluations has never been studied~   "
89988|NCT02389270|"~     The aim of this study is to analyse urinary neurotrophin levels in healthy children. Urine~     samples will be collected at 3 different times of day (morning, noon, and evening) at urge~     sensation from all age groups of children who gained bladder control, i.e. from 3-18 years of~     age. Urinary levels of nerve growth factor (NGF) and brain-derived neurotrophic factor (BDNF)~     normalised to urinary creatinine will be analysed. Age and daytime related variations will be~     reported for both boys and girls. These results will contribute to understanding the role of~     neurotrophins in the physiology of lower urinary tract and pathophysiology of idiopathic and~     secondary hyperactive bladder in children.~   "
89989|NCT02389257|"~     Optically Pumped 4He Magnetometers operability for cerebral and cardiac magnetic fields~     measurement.~   "
89990|NCT02389244|"~     INDICATION:~      Metastatic bone sarcomas: conventional high grade osteosarcoma, Ewing sarcoma of bone,~     intermediate or high-grade chondrosarcomas and chordomas~   "
89991|NCT02389231|"~     The investigators have demonstrated that the mean percentage of circulating CD8+ regulatory T~     (CD8 Tregs) cells is significantly higher in patients with warm hemolytic anemia (wAHAI) in~     remission than in controls and is correlated to hemoglobin levels. In vitro, low dose of~     interleukine-2 (IL2) induce the expansion of CD8 Tregs. The objective is to demonstrate that,~     over a 9 week treatment period; low doses of IL2 can induce the expansion of CD8Tregs in~     patients with active wAHAI.~   "
89992|NCT02389218|"~     Prospective trial comparing the efficacy and safety of CryoBalloonAblation (CBA) to~     standardized medication for treatment of early onset persistent atrial fibrillation (AF)~     without structural heart disease. The value of CBA in these patients has never been studied;~     the endpoints for persistent patients are much easier than for paroxysmal patients. Reduction~     in left atrial (LA) size will be compared versus patients on drug therapy and versus failing~     patients.~   "
89993|NCT02389205|"~     Background Hemophilia is a sex-linked genetic disorders. When the joint or the muscles is~     bleeding, it may cause haemarthrosis, synovium, cartilage tissue thickening, joint activity~     (Range of Motion) decreasing and other musculoskeletal and related disorder. Patients will~     produce pain in the action, compensatory action occurs, thus causing recurrent of bleeding,~     and joint damage. There is high rate of ankle joint bleeding in hemophilia. The ankle~     articular joint disease will affect lower limbs activities, and the functional activities~     will impaired.~      Review studies, in addition to physical therapy, Kinesio taping is a common intervention to~     improve other subjects' static balance, proprioception, functional ankle stability, correct~     poor posture.~      The main intervention of this study is physical therapy and Kinesio taping, expect to improve~     the stability and muscular strength of lower extremities, and balance, correcting gait and~     lower extremity functional activities of subjects with hemophilia.~   "
89994|NCT02389192|"~     Background:~      - Ebola is a virus that can spread quickly and causes serious disease. It is currently~     causing an outbreak in West Africa. There are no approved treatments for Ebola. ZMappTM is a~     new drug made of natural infection-fighting substances. Researchers want to see if it can~     treat Ebola.~      Objective:~      - To assess the safety of ZMappTM and how the body processes it. To measure the immune system~     response to ZMappTM.~      Eligibility:~      - Healthy people 18 50 years old.~      Design:~        -  Participants will be screened with a medical history, physical exam, and blood and urine~          tests. They will have an electrocardiogram (ECG) to measure heart electrical activity.~          Small pads will be stuck to the arms, legs, and chest.~        -  Participants will be admitted to the hospital. They will have a physical exam,~          medication review, and blood samples.~        -  Two intravenous (IV) lines will be placed into separate arm veins. A needle will be used~          to guide plastic tubing into the veins. One will be used to take blood samples. The~          other will be used to give the study drug.~        -  Participants will be given drugs to help prevent side effects.~        -  Participants will be given the study drug by IV over 10 12 hours. Participants will be~          monitored closely and vital signs taken frequently. They may have another ECG.~        -  Blood samples will be taken before, during, and after the infusion.~        -  Participants will stay in the hospital 1 or 2 nights after receiving the drug.~        -  Participants will have several study visits over 90 days after getting the study drug.~          They will be asked about side effects. They may have a physical exam, and blood may be~          drawn.~   "
90004|NCT02389062|"~     This is a clinical trial to evaluate the sensitivity of noninvasive, novel markers of gluten~     ingestion in celiac disease patients who are following gluten free diet for at least a period~     of one year. These noninvasive markers may be helpful to monitor the silent intestinal~     damage, possibly resulting from the accidental consumption of gluten due to cross~     contamination of gluten free diet.~   "
92092|NCT02361723|"~     This study will evaluate the safety, tolerability, pharmacokinetic profile and treatment~     effect of a new drug known as BGB-290 in patients with solid tumors.~   "
89995|NCT02389179|"~     Much research on vitamin D status has focused on seasonal variations in serum 25(OH)D levels~     in populations living at high altitudes and those of light-skinned Caucasian extraction, with~     little work done in multi ethnic populations living closer to the equator with regards to~     Vitamin d supplementation, prevalence, predictors and associations of hypovitaminosis D - the~     assumption, perhaps being vitamin D deficiency is unlikely in locations of plentiful~     sunshine. There is a dearth of studies on Vitamin D status in a group of subjects at~     especially high risk of falls/fractures i.e. post-menopausal women with osteoporosis living~     in South-East Asia. It is possible that differences in geography and ethnicity/culture~     amongst women with post menopausal osteoporosis (PMO) in Malaysia may necessitate~     supplemental Vitamin D doses that differ from those prescribed to North American Caucasians.~      There is no unified consensus on the dose of Vitamin D supplementation. Neither is there~     agreement on definitions of sufficiency with some researchers targeting levels of serum~     25(OH)D of >20ng/ml and others aiming for levels above 30ng/ml. The Institute of Medicine~     (IOM) 2010 guidelines, aiming for a lower serum 25(OH)D target of 20ng/ml, advocates~     maintenance doses of 600 IU/day in Postmenopausal women aged 51-70 and 800 IU/day for those~     aged >70 years. On contrary, the Endocrine Society 2011 guidelines state that maintenance~     doses up to 1500-2000 IU/day may be required to attain a higher optimal target of >30ng/ml.~     On addition, the 2014 National Osteoporosis Foundation Guidelines recommended that the~     Vitamin D level should be brought up to approximately 30ng/ml, and to maintain at this level~     taking into account those with limited sun exposure, obese and dark skin individuals, the~     daily requirement ranges from 800-2000 IU/day.~      The investigators therefore designed a prospective randomized controlled trial comparing~     efficacy and safety of a low (900 IU/day) and high (1800IU/day and 3300IU/day) maintenance~     dose of Cholecalciferol (Vitamin D3) amongst community dwelling Indian and Malay with PMO~     living in Kuala Lumpur, Malaysia.~      Hypothesis of the study is despite abundant exposure to sunlight, which is the main Vitamin D~     supplier, those who dress conservatively and individuals with darker skin may require a~     higher dose of Vitamin D to maintain sufficiency (>30ng/ml).~   "
89996|NCT02389166|"~     Background : Patient with hypoxemic respiratory failure treated with NIV receive between NIV~     session oxygen therapy. Gaz exchange disorder with a decrease of the ratio between Partial~     Pressure of Arterial Oxygen (PaO2) and Inspired Fraction of Oxygen (FIO2) are noticed when~     NIV is stopped at the end of the session du to alveolar derecruitment Optiflow is a high flow~     oxygen delivery system used a heated humidifier and heated breathing circuit. In~     observational studies, Optiflow increase oxygenation of patients with hypoxemic respiratory~     failure. Oxygenation is better than under high-concentration mask and work of breathing is~     reduced.~      The aim of the study is to compare in acute hypoxemic respiratory failure, optiflow to oxygen~     therapy under high-concentration mask, on patients oxygenation between NIV sessions (measured~     as the difference between PaO2/FiO2 ratio at the beginning and at the end of the session),~     during the first two NIV sessions~      Study design : Prospective, randomized, controlled, multicentric, open clinical trial with~     two groups:~        -  control group with conventional clinical management, oxygen therapy and sequential used~          of NIV~        -  Optiflow group with high flow oxygen delivery system, conventional clinical management~          and sequential used of NIV for a period of 36 hours at least.~      Number of subjects: 100 (50 patients per group) patients admitted in intensive Care Unit for~     hypoxemic respiratory failure.~   "
89997|NCT02389153|"~     The main focus of the pilot study is to evaluate the feasability and effectiveness of a~     collaborative care intervention for patients suffering from a coronary heart disease (CHD)~     with insufficient controlled health related risk factors in their lifestyle. The design of~     the study is a wait list control design. 30 patients will receive treatment immediately after~     submission, the other 30 after 6 months. An interdisciplinary team, including a care manager~     for each patient, will offer an individualized treatment plan, based on shared decision~     making for each patient to reduce risk factors and improve quality of life.~   "
89998|NCT02389140|"~     The physiological response at the myofascial trigger point (MTrP) to massage is not known,~     yet would provide important objective evidence for a treatment effect and clarify the~     resolution process of a MTrP.~   "
89999|NCT02389127|"~     Cirrhosis and advanced liver disease have been associated with an increased risk for~     hyperglycemia and type 2 diabetes mellitus (T2DM). The diagnostic yield of common tests used~     to define diabetes and insulin resistance in the general population differs significantly~     from the one observed in patients with liver disease. Glycosylated hemoglobin A1c (HbA1c), a~     reliable test to assess chronic glycemia and recommended both for the diagnosis and~     monitoring of T2DM, is neither accurate nor reliable in patients with cirrhosis. A validation~     study has not been performed to define its true usefulness in the setting of cirrhosis. The~     study aims to determine the level of HbA1c that better corresponds to the diagnosis of T2DM -~     as determined by an oral glucose tolerance test (OGTT) - and to correlate the levels of HbA1c~     with the average glucose over a 12-week period in patients with cirrhosis and known T2DM, in~     cirrhotic patients with different degrees of liver impairment as compared to patients with~     T2DM and no liver disease.~   "
90000|NCT02389114|"~     The primary hypothesis of this study is that the higher concentration of soy protein intake~     will increase satiety and decrease the energy intake at the subsequent meal.~      The secondary hypothesis is that the synergistic effect of soy protein and polydextrose will~     further increase satiety and reduce energy intake at the subsequent meal.~      The third hypothesis is that the ingestion of protein and polydextrose will differentially~     impact on satiety-related metabolism, i.e. blood glucose, insulin, urea, plasma amino acids,~     gut hormones and gastric emptying.~   "
90001|NCT02389101|"~     Lymphomas are classified as Hodgkin's or non-Hodgkin's lymphomas, of which especially the~     latter represent a heterogeneous group with varying patterns of prognosis, biological~     behaviour and response to treatment. 18F-FDG PET/CT is useful for staging and response~     monitoring but has the disadvantage of associated radiation exposure which may not be~     desirable for young patients. Advanced MRI techniques including diffusion weighted imaging~     (DWI) are increasingly used for improved lesion detection and characterisation of lymphomas~     and in the whole-body mode offer a promising radiation-free alternative to CT. Molecular~     imaging in turn is important in theranostics medicine where detection of therapeutic target~     is essential. The concept of theranostics has been successfully adapted to management of~     neuroendocrine tumors (NET) where peptide receptor radiotherapy (PRRT) is offered to patients~     progressing on treatment with long-acting somatostatin analogues.~      Recently in the investigator's hospital a case of diffuse large B-cell lymphoma (DLBCL) was~     initially misdiagnosed as NET because of high uptake of 68Ga-DOTANOC in pancreatic tumor at~     PET/CT. A PubMed search revealed a similar case report in bronchial tumor which turned out to~     be DLBCL (Jain et al. Clin Nucl Med 2014;39:358-359). Bearing these two cases in mind the~     investigators now aim to systematically study somatostatin receptor status (ssr) by measuring~     uptake of 68Ga-DOTANOC with PET/CT in patients with newly diagnosed non-Hodgkin's and~     Hodgkin's lymphoma. The imaging findings will be compared to immunohistochemically determined~     ssr-subtypes 2,3 and 5 obtained from pre-treatment fresh tumor samples and 18F-FDG PET/CT~     which is part of standard diagnostic evaluation. Furthermore, whole-body MRI with DWI will be~     performed before, during and after chemotherapy to define the most sensitive and specific~     imaging method appropriate for routine diagnosis and follow-up. This study has potential~     implications for future response monitoring and follow-up imaging techniques in patients with~     malignant lymphoma and provides additional biologic characterization which may be useful for~     novel therapeutic approaches such as PRRT.~   "
90002|NCT02389088|"~     The purpose of this study is to evaluate the effect of increased circulating androgens on~     estradiol production by the granulosa cells in response to FSH stimulus.~   "
90005|NCT02389049|"~     This study is designed to study DNA sequencings for mutations in a research genetic test~     panel of genes (which contains all 32 known and/or published genes associated with PCD). The~     study aims to show that about 70% of PCD patients have biallelic mutations in one of these~     genes. This project will enroll patients who have already had a clinical evaluation, and have~     clinical features consistent with PCD.~   "
90006|NCT02389036|"~     Introduction- Hospital acquired infections (HAI) are a major cause of morbidity and mortality~     and increase health care costs. Critically ill patients are particularly susceptible to these~     infections and have an even higher mortality. One intervention that has gained much interest~     in the medical literature for reducing infection rates and deaths from HAIs is selective~     decontamination of the digestive tract (SDD). SDD involves the application of antibiotic~     paste to the mouth, throat, stomach and a short course of intravenous antibiotics. The~     evidence supporting the use of SDD for saving lives and preventing infections is actually~     quite strong. However, health care professionals in many parts of the world have refrained~     from using SDD due to fears of the effects of overuse of antibiotics on the frequency of~     infections with resistant bacteria such as multi-resistant Gram negative organisms, MRSA and~     Clostridium difficile.~      SuDDICU-ANZ is a cross-over, cluster randomised trial comparing the effect of using selective~     decontamination of the digestive tract (SDD) plus standard care, to standard care alone on~     hospital mortality in patients receiving mechanical ventilation in the intensive care unit~     (ICU).~      Secondary outcomes include an ecological assessment and a long-term health economic analysis.~   "
90007|NCT02389023|"~     The purpose of this study is to evaluate the effectiveness of negative pressure incision~     management system (Prevena™ Incision Management System (PIMS) or ActiVAC® with the Prevena™~     Dressings (Peel and Place™ or Customizable™), KCI) in the prevention of wound complications~     including surgical site infection (SSI) and non-infectious complications in patients~     undergoing vascular surgery with groin incisions.~   "
90008|NCT02389010|"~     A novel method (PCT n. WO 2010/007502 A2, 2010) has been developed to obtain platelet gel~     from umbilical cord blood (CBPG). The main advantages so far identified in CBPG as compared~     to platelet gel derived from adult platelets relate to the lack of microbiological~     contamination in the former and to a different profile of growth factors concentrations, such~     as a higher content of VEGF and lower content of TGF in CBPG. Recent developments have led to~     a procedure in which CBPG can be prepared, stored in a cryopreservation bag and applied to~     the skin ulcer without breaking the sterility chain. In spite of promising results on~     allogeneic CBPG, a randomized clinical trial of sufficient statistical power to detect~     significant advantages (clinical and economical) will be performed in patients affected by~     diabetic foot ulcers and randomly treated with CBPG versus standard local medications~     (SLM).This study is a multicenter (8 centers) controlled randomized clinical trial. Outcomes:~     (1) primary objective is to evaluate the number of closed skin ulcers within 4 weeks of~     treatment with CBPG vs standard local medications; (2) secondary objectives are percent skin~     ulcer closure area, number and type of adverse events and cost of treatment. Sample size~     calculation: 95 + 5 (dropout) test and 95 + 5 (dropout) control patients ensure 80% power to~     detect as statistically significant (p<0.05) >60% healing in test vs 40% healing in~     control.Each clinical centre has been invited to enrol 15 treated and 15 control patients,~     according to local availability in 12 months. CB units are routinely collected after mother's~     informed consent before and after placenta delivery in accredited public cord blood banks~     belonging to the Italian Cord Blood Network (ITCBN) coordinated by the Centro Nazionale~     Sangue (CNS). After storage and transportation at monitored room temperature, the units will~     be processed for the preparation of CBPG within 48 hours of collection. CBPG will be prepared~     according to standard procedures with a defined final platelet concentration (0.8-1.2 x~     109/L). The CBPC units will be finally cryopreserved in a -80°C freezer in view of the~     clinical use of the CBPG, which will require thawing at 37°C in a waterbath and activation~     with Calcium gluconate. For SLM, each clinical center will use their validated standard~     procedures.~   "
90009|NCT02388997|"~     Population surveys have shown a positive correlation between increased levels of total serum~     immunoglobulin E (IgE) and bronchial hyperreactivity. However, it is also clear that~     exacerbations of asthma are frequently triggered by viral respiratory tract infections,~     especially those caused by human rhinovirus (RV), also known as the common cold virus. This~     protocol explores the relationship between rhinovirus and allergen/IgE provoked inflammation.~     Experimental challenges with human (RV) result in more persistent upper respiratory tract~     symptom scores in asthmatics than in controls. Asthmatics with high levels of IgE also show~     greater sensitivity to methacholine and higher levels of expired nitric oxide (eNO) than~     those with low levels of IgE. These data suggest that patients with asthma and high levels of~     IgE are more likely to have pre-existing inflammation of the airways before virus challenge.~     This study is being done to determine whether anti-IgE therapy (with omalizumab) will lead to~     a significant decline in inflammatory biomarkers prior to virus inoculation, and thus reduce~     the severity of clinical manifestations after an experimental human RV challenge.~   "
90010|NCT02388984|"~     The purpose of this study is to evaluate the efficacy and safety of Compound Danshen Dripping~     Pills in patients with diabetic retinopathy(Syndrome Of Qi-Stagnation and Blood Stasis).~   "
90011|NCT02388971|"~     The purpose of this study is to evaluate the effect of MLN1202 on arterial inflammation in~     participants with stable atherosclerotic cardiovascular disease (CVD) who are receiving~     standard-of-care (SOC) therapy.~   "
90012|NCT02388958|"~     Gestational diabetes mellitus (GDM) is associated with short-term and long-term complications~     for infants and mothers. The management of GDM during pregnancy focuses on reducing risks to~     the infant associated with hyperglycemia. The postpartum management of GDM focuses on~     reducing maternal risk of developing type 2 diabetes (T2DM). A diagnosis of GDM identifies up~     to 31% of parous women who will eventually develop T2DM and approximately 50% of women~     diagnosed with GDM will develop T2DM in the first 5 years postpartum. The perceived risk of~     developing short-term and/or long-term complications of GDM may influence women's likelihood~     of engaging in diet modification, the mainstay of treatment of GDM, both during and after~     pregnancy. If sustained after delivery, diet modifications introduced as treatment for GDM~     could affect maternal weight changes during and after pregnancy, which could in turn affect~     T2DM risk. It is unknown if and how women with GDM differ in their perceived risk of~     developing T2DM, dietary choices, or weight gain (and retention) during versus after~     pregnancy. Therefore, the project proposed in this application seeks to (1) characterize the~     perceived risk of developing T2DM among women with GDM during and after pregnancy, (2)~     characterize dietary choices of women with GDM during and after pregnancy, and (3)~     characterize weight changes of women with GDM during and after pregnancy as compared to women~     without GDM.~   "
90013|NCT02388945|"~     This prospective, randomized, controlled, multi-center clinical trial will evaluate the~     validity and security of domestic APD machine compared with the patients followed CAPD.~   "
90014|NCT02388932|"~     This phase I trial studies the side effects and best dose of stereotactic body radiation~     therapy in treating patients with head and neck cancer that has spread from where it started~     to nearby tissue or lymph nodes and is at high risk for continuing to spread because the~     patient cannot undergo standard chemotherapy. Stereotactic body radiation therapy is a~     specialized radiation therapy that delivers radiation directly to the tumor in smaller doses~     over several days, which may kill more tumor cells and cause less damage to normal tissue.~   "
90015|NCT02388919|"~     Evaluate the efficacy and safety of Anlotinib as the 3-line treatment of patients with~     advanced non-small lung cancer, with placebo control.~   "
90016|NCT02388906|"~     The purpose of this study is to determine whether nivolumab is better than ipilimumab to~     prevent recurrence of melanoma.~   "
90017|NCT02388893|"~     As recommended in the Guidelines on the prevention, diagnosis, and treatment of infective~     endocarditis (IE) patients with IE should be evaluated and managed by a multispecialty team~     including an cardiologist, infectious disease specialist, and cardiac surgeon. Our registry~     is a prospective, national registry of patients with IE. From January 2013 data from~     endocarditis board were prospectively recorded using standard definitions during the~     hospitalization. Patient demographics, clinical, laboratory, and imaging data at the time of~     IE diagnosis, as well as treatment outcomes were entered into the ER-UHC database.~   "
90018|NCT02388880|"~     The purpose of the study is to evaluate the physiological response to application of the~     Intrathoracic Pressure Regulator (ITPR) in patients with compromised cerebral circulation.~     The study will evaluate the physiological response to intrathoracic pressure regulation (IPR)~     therapy in hemodynamically stable patients with compromised cerebral circulation who are on~     ventilatory support.~   "
90019|NCT02388867|"~     In the present study the investigators will evaluate MMPs. serum levels variations in~     patients affected by critical limb ischemia, before and after lower limb surgical~     revascularization through venous or prosthetic bypass.~   "
90020|NCT02388854|"~     Endometriosis, defined as the presence of endometrial tissue outside the uterine cavity,~     affects 6-10% of the general population of women in childbearing age.~      The pathogenesis of the disease is unknown. The purpose of this study is to evaluate the~     influence of certain polymorphisms of genes Transforming growth factor beta 1~     (TGFB1),Vascular endothelial growth factor (VEGF), Epithelial growth factor receptor (EGFR)~     and Platelet-Derived Growth Factor (PDGF) knowns to be involved in angiogenesis, tissue~     remodeling and proliferation, phenomena necessary for the growth of ectopic foci of~     endometrial tissue , and genes X-ray repair cross-complementing protein 1 (XRCC1), X-ray~     repair complementing defective repair in Chinese hamster cells 3 (XRCC3) and xeroderma~     pigmentosum group D (XPD) involved in DNA repair systems, needed in case of damage from~     oxidative stress, another potential factor involved in the pathophysiology of endometriosis.~     The study focus on the Sardinian population, known to have unique genetic characteristics due~     to geographical isolation.~   "
90021|NCT02388841|"~     ABSTRACT Pulmonary embolism shows a wide spectrum ranging from clinically asymptomatic~     thrombus to massive thrombus, leading to cardiogenic shock. The purpose of this study was to~     determine the association between thrombus localization and risk factors, accompanying~     disorders, D-dimer and the red blood cell distribution width (RDW) in patients with pulmonary~     embolism.~   "
90022|NCT02388828|"~     This is a non-therapeutic, long-term follow-up (LTFU) study of subjects who have received~     retroviral-based gene therapy products in cancer studies. All subjects in this LTFU protocol~     have received lentiviral modified T cells engineered to express an anti-mesothelin scFv~     Chimeric Antigen Receptor (CAR). This gene therapy product is called CART-meso. Lentiviruses~     are a subfamily of retroviruses. This protocol is designed in adherence with the November~     2006 Food and Drug Administration (FDA) Guidance for Industry, Monitoring for Delayed~     Adverse Events and Supplemental Guidance on Testing for Replication Competent Retrovirus in~     Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical~     Trials Using Retroviral Vectors  and involves up to 15 years of monitoring of subjects who~     have been exposed to retrovirus-mediated gene transfer. Subjects will undergo biannual visits~     for a blood test evaluating persistence of cells with retroviral vector sequences, chemistry,~     hematology and tumor markers (as applicable). On annual visits, subjects will further undergo~     a physical exam and medical history (including concomitant medications and adverse events)~     with careful attention to features possibly related to retrovirus-induced diseases~   "
90023|NCT02388815|"~     To evaluate the point accuracy of the Abbott Sensor Based Glucose Monitoring System when used~     at home by children with diabetes.~   "
90024|NCT02388802|"~     Ten patients will undergo uterine transplantation.~   "
90025|NCT02388789|"~     The purpose of this study is to investigate whether mechanoreceptor sensitivity of the sole~     of the feet increases with increased foot temperature and how a heightened sensation may~     improve characteristics of balance control and gait. As an extension, the investigators also~     want to determine whether lower limb movement is an efficient activity of increasing foot~     temperature. There are several objectives of this study. The investigators want to determine~     the effect of active recovery (via lower limb movements) on increasing plantar temperature,~     determine the effect of increased plantar temperature on plantar sensation and determine the~     effect of increased plantar sensation on balance control and gait characteristics.~     Participants will be asked to complete various tasks under different conditions. Conditions~     include decreased feet temperature via ice bath emersion, baseline feet temperature~     (participant's normal temperature after a ten minute equilibration period), and increased~     feet temperature via active movement of the lower limb. Tasks include walking across the~     room, performing active movement of the lower limb and a 10 minute treadmill walk. Gait~     movement will be collected with a three-dimensional motion capture system (Optotrak) and~     force plates. Feet temperature and sensation information will be collected with a temperature~     probe (infrared) and monofilaments.~   "
90026|NCT02388776|"~     This is an interventional pilot study of 40 burn inpatients. Specific aims of the proposed~     pilot study are to use bedside blood analysis with rotational thromboelastometry (ROTEM) in~     severe burn patients to provide preliminary information on the nature of coagulation~     abnormalities and compare subject ROTEM coagulation profiles within 24 hours of burn injury~     (day 1) and on days 2, 3, 5, 7, 14 and 21 after burn injury.~   "
90027|NCT02388763|"~     The purpose of this study is to evaluate the functional vision of 2 daily disposable silicone~     hydrogel contact lenses using Time Controlled Visual Acuity (TCVA) measurements at high~     luminance and high contrast after 10+/-3 days of wear post 3 hour exposure to a reduced~     humidity environment.~   "
90028|NCT02388750|"~     This phase II study will investigate the use of palonosetron in the efficacy of prophylaxis~     or rescue of single or multiple fraction radiation induced nausea and vomiting. This~     prospective study employs a parallel arm design, allowing for inclusion of patients with~     pre-existing nausea and vomiting versus no current nausea or vomiting. Eligible patients~     receiving radiotherapy known to have a low or moderate emetogenic risk will receive every~     other day dosing of 0.5 mg palonosetron for the length of treatment. Nausea, vomiting, use of~     rescue medication, and impact on quality of life will be monitored during and after radiation~     treatment completion.~   "
90029|NCT02388737|"~     This is a comparative study of vonoprazan (TAK-438) (10 mg or 20 mg) in participants in whom~     endoscopic healing of erosive esophagitis has been confirmed with vonoprazan or adequate~     treatment with a proton pump inhibitor (PPI), to demonstrate the non-inferiority of~     vonoprazan to lansoprazole in their maintenance treatment (6 months or 24 weeks) as well as~     to determine the clinically recommended dose for vonoprazan for maintenance therapy in~     erosive esophagitis.~   "
90030|NCT02388724|"~     The purpose of the study is to demonstrate the efficacy of vonoprazan (TAK-438) versus~     lansoprazole in the treatment of erosive esophagitis classified as Los Angeles (LA)~     classification grades A to D at Week 8.~   "
90031|NCT02388711|"~     The goal of the project is to conduct a prospective, randomized-controlled clinical trial to~     determine the extent to which the Coordinated-Transitional Care (C-TraC) program impacts~     transitional care quality, patient cognition/function, caregiver stress and 30-day~     rehospitalizations in patients with documented diagnoses of dementia discharged from the~     hospital to the community.~   "
90032|NCT02388698|"~     The addition of concurrent chemotherapy to definitive radiation has improved the 5-year~     survival of women with locally advanced cervical cancer to 58%. To determine if plasma HPV~     DNA predates clinical recurrence and/or improves the accuracy of metabolic response on~     FDG-PET at 3 months post completion of radical chemo-radiation in patients with locally~     advanced cervical cancer. Post therapy FDG-PET can help predict progression free survival and~     overall survival. In addition plasma HPV can be used to monitor response and detect early~     recurrence. Prospective study will recruit 20 patients with locally advanced cervical cancer~     to determine if plasma HPV DNA predates clinical recurrence and/or improves the accuracy~     response on post-therapy FDG-PET scan at 3 months.~   "
90033|NCT02388685|"~     The goal is to test the ability to detect improved calf muscle perfusion and energetics in~     PAD patients in a randomized controlled trial of home exercise therapy. Eighty patients will~     be randomized to a 12 week home exercise program or no program (control).~   "
90034|NCT02388672|"~     Coffee as one of the most favorite worldwide beverages comprises a variety of chemicals with~     health benefits. Most investigations have so far focused on the beneficial effects of~     caffeine but knowledge about non-caffeine coffee compounds such as chlorogenic acid (CGA) is~     scarce. The reducing risk of a variety of diseases following CGA consumption has been~     mentioned in recent basic and clinical studies. However, there is a lack of studies that~     examine the behavioral effects of CGA. This study aims to fill this gap.~      In a randomized double-blind study, the investigators test the acute effects of coffee~     enriched with CGA or CGA supplement on physiological functions such as blood pressure, blood~     glucose, and heart rate, and on psychological functions such as mood and cognitive~     performance in 30 healthy adult subjects (18-40 years).~      Participants will be allocated to an intervention plan using computer-generated random~     numbers. Treatments comprise of (1) 6g decaffeinated (5 mg caffeine) coffee (250 ml) with~     high total CGA (560 mg), or (2) 6g decaffeinated coffee (250 ml) with normal total CGA (224~     mg), or (3) 6g decaffeinated coffee (250 ml) with normal total CGA and 800mg green coffee~     bean extract with total CGA (560mg), or (4) 6g decaffeinated coffee (250 ml) with normal~     total CGA and placebo, or (5) no treatment group. Upon arrival in the laboratory,~     participants will complete a 24-hour food recall, a psychometric test battery, and mood and~     cognitive performance tests. The tests will be repeated 40 min following CGA application,~     which coincide with the approximated peak of CGA blood concentrations and at 120 min post~     treatment. Blood pressure, blood glucose and heart rate recordings will be taken prior to~     treatment and at 1, 30, 60, 90 and 120 min post-treatment. The response to GCE-enriched~     coffee will be compared to GCE supplement for each of the groups of variables.~   "
90035|NCT02388659|"~     The Investigators will examine the disease specificity of 2-hydroxyglutarate in non-glioma~     brain lesions, and the clinical utility of 2-hydroxyglutarate, glycine and citrate in IDH~     mutated gliomas and IDH wild type gliomas.~   "
90036|NCT02388646|"~     The goal of this study is to explore the effectiveness of a commercially available,~     over-the-counter knee brace in the conservative treatment of knee osteoarthritis.~     Participants will either be fitted with a brace and told to wear it every day during normal~     activities, fitted with the brace and given instructions on a set of quadriceps strengthening~     exercises to complete twice daily, every day, or be given the exercise instructions, but not~     fitted with a brace. Functional and subjective outcomes will be collected preoperatively and~     at 6 and 12 weeks from baseline, with the goal of informing the effectiveness of bracing~     alone versus a home exercise program, and whether the combination of those provides the most~     therapeutic benefit to participants.~   "
90037|NCT02388633|"~     Severe hypercholesterolemia produced by conditions such as heterozygous familial~     hypercholesterolemia is associated with multiple complications including premature~     atherosclerotic disease. There is evidence that microvascular perfusion, particularly flow~     reserve, in critical organs is limited due to abnormalities in plasma viscosity, abnormal RBC~     deformability, and an imbalance between vasodilators and vasoconstrictors. There is little is~     currently known about acute changes in microvascular blood flow and microvascular rheology~     that occur in response to plasmapharesis which is used in some patients to lower critically~     elevated cholesterol levels. Our research group has pioneered CEU methods for assessing~     myocardial and skeletal muscle perfusion, and has previously demonstrated in pre-clinical~     models that acute hyperlipidemia produces a reduction in microvascular RBC transit rate. In~     this study, the investigators will assess acute changes in microvascular perfusion in~     patients undergoing clinically-indicated plasmapharesis.~   "
90038|NCT02388620|"~     The purpose of this study is to evaluate the pharmacokinetics (PK), safety and tolerability~     of a single oral dose of LEE011 in subjects with varying degrees of impaired hepatic function~     (based on Child-Pugh classification) as compared to demographically-matched control subjects~     with normal hepatic function.~   "
90214|NCT02386319|"~     ﻿The study's main objective is to investigate melatonin's analgesic, anxiolytic and~     sleep-regulating effects in patients undergoing cosmetic breast surgery. Moreover, the~     investigators intend to investigate the pharmacokinetic parameters of melatonin in this~     patient population.~   "
90039|NCT02388607|"~     Schizophrenia is a psychiatric pathology, which concerns around 1% of adult population. It is~     characterized by clinical symptoms combining positive and negative symptoms and thinking~     disorganization. Schizophrenia is also characterized by cognitive deficits, likely to play an~     important part in adaptation of these patients in their every-day life, and to affect their~     clinical symptomatology. Among them, there are deficits in sustained attention which are~     associated with a difficulty for these patients to maintain efficiently their cognitive~     activity on a source of stimulation or task. This basic attentional process is fundamental~     for the efficiency of the overall of cognitive processes, and so for all behaviors directed~     on an aim. The question of whether or not patients with schizophrenia have difficulty~     sustaining attention is of high relevance, in the sense that it could undermine performance~     on nearly any task and so provide a compelling causal explanation of many other impairments~     observed in these patients. Yet it has not been conclusively answered in over four decades of~     research. Consequently, the main objective of the protocol is to evaluate sustained attention~     abilities in schizophrenic patients and to better understand the specific functioning of~     cognitive and neural mechanisms underlying these abilities (attentional resources and~     cognitive control mechanisms).~   "
90040|NCT02388594|"~     This is a triple cohort, open-label pilot study of the safety and antiviral activity of a~     single infusion of autologous CD4+ T cells genetically modified at the CCR5 gene by Zinc~     Finger Nucleases SB-728mR (ZFN Modified CD4+ T Cells) using electroporated mRNA with or~     without the prior administration of two different doses of cyclophosphamide.~   "
90041|NCT02388581|"~     Aims: A nationwide study to prospectively validate~        1. The complete histological and molecular remission rate for antibiotics as 1st-line~          therapy for early-stage Hp-positive gastric pure (de novo) DLBCL~        2. The durability of complete histological remission after antibiotics~        3. The usefulness of pattern of NF-kB, BCL10, BAFF, and CagA by IHC staining in~          prospectively predicting the Hp-dependence of gastric pure (de novo) DLBCL~        4. The frequency of t(11;18)(q21;q21) translocation in gastric pure (de novo) DLBCL in~          Taiwan.~        5. The association between the CYP2C18/CYP2C19 genetic polymorphisms and eradication of Hp~          infection after antibiotics.~   "
90042|NCT02388568|"~     The proposed 12-month randomized controlled trial will assess the efficacy of lifestyle~     counseling, combined with lorcaserin (10 mg BID) or placebo, in maintaining weight loss~     achieved during a prior 14-week dietary run-in.~      14-week run-in. To qualify for randomization, participants must lose ≥5% of initial weight in~     the 14-week dietary run-in. This loss will be achieved with the provision of weekly, group~     lifestyle counseling, which includes a 1000-1200 kcal/day portion-controlled diet that~     combines four daily servings of a liquid diet (HMR shakes) with an evening meal of a~     frozen-food entree (and a fruit and vegetable serving). More than 70% of participants are~     expected to achieve the 5% criterion loss during the 14-week run-in.~      A total of 182 women and men with a BMI ≥33 and ≤55 kg/m2, without co-morbidities, or ≥30 and~     ≤55 kg/m2 (with a co-morbid cardiovascular disease (CVD) condition) will be enrolled in the~     4-month run-in period. Prior to enrollment, all participants will have a history, physical~     exam, electrocardiogram (EKG), and appropriate blood tests. They will attend weekly group~     sessions for 14 weeks. Participants will have a brief medical visit at week 8 to check their~     health and blood tests will be repeated. The investigators anticipate that 136 (75%)~     participants will lose 5% or more of initial weight and qualify for randomization.~     Participants who do not lose 5% will be provided a list of weight loss resources (e.g., other~     programs) to facilitate their continued weight management.~      12-month randomized trial with lorcaserin. A total of 136 participants who have lost 5% or~     more of initial weight in the run-in period will be randomly assigned, in double-blind~     fashion, to lorcaserin (10 mg BID) or matching placebo. To be eligible, participants must~     have a BMI (after prior weight loss) ≥30 kg/m2 (without co-morbidities) or greater than or~     equal to ≥27 (with a co-morbidity). Randomization will be performed by the Investigational~     Drug Service at the Hospital of the University of Pennsylvania. Prior to randomization, all~     participants will complete a second brief history and physical examination, as well as an EKG~     and blood tests. Medication will be dispensed at the randomization visit and at brief medical~     visits that follow. Over the 1 year, all participants will participate in 16 group lifestyle~     modification classes designed for weight loss maintenance, approximately half of which will~     be delivered by group conference call.~      Primary outcome measure. The primary endpoint is change in body weight (in kg), as measured~     from randomization to month 12. The co-primary end-point is the percentage of participants in~     the two groups that, at month 12, maintained the ≥5% reduction in body weight achieved during~     the 14-week dietary run-in period. Secondary efficacy endpoints include changes in CVD risk~     factors, glycemic control, and quality of life, as measured from randomization to month 12.~     Exploratory endpoints include changes in these CVD and related outcomes, as measured at the~     start of the 14-week run-in period to month 12. The investigators also will examine the~     percentage of participants in the two groups who at month 12 achieved losses of ≥5%, ≥10%,~     and ≥15% of initial weight, as measured from the start of the run-in period.~      Safety endpoints will include physical examination, electrocardiogram, adverse events (AEs),~     standard laboratory tests, and mental health assessed by the Columbia Suicidality Severity~     Rating Scale (C-SSRS) and Patient Health Questionnaire (PHQ-9).~      Statistical Analysis. The planned sample size of 136 participants, with a 1:1 randomization~     ratio, assumes a 20% drop-out rate (at month 12) and was estimated to be adequate to evaluate~     the primary endpoint with power ≥90% (P=0.05, two-sided test). The investigators predict a~     difference in weight change between the two groups (from randomization to month 12) of 4 kg~     (SD=3.5). Pre-specified data analysis will be performed on the full analysis set, comprising~     all randomized individuals exposed to trial drug with at least one post-randomization weight~     assessment.~   "
90043|NCT02388555|"~     Currently there is paucity of information on the prevalence of pre-operative coronal~     imbalance in patients with degenerative lumbar scoliosis (DLS) and its influence on surgical~     outcomes. This study aims to investigate in DLS, the prevalence of coronal imbalance, to~     propose a novel classification system and to investigate whether pre-operative coronal~     imbalance affects clinical outcomes following osteotomy. A total of 284 DLS patients were~     recruited.~   "
90044|NCT02388542|"~     The investigators propose conducting a pilot study to identify 6 worksites (2 India, 2 Sri~     Lanka, 2 Bangladesh) explore barriers to optimum cardiovascular disease(CVD) care at these~     worksites, quantify risk factor level in worksite populations and identify and train peer~     mentors to deliver an educational intervention to improve life style and enhance medication~     adherence among those at moderate to high risk of cardiovascular disease (CVD).~   "
90045|NCT02388529|"~     This study is a single-center, randomized, double-blind, placebo-controlled study in patients~     with stable heart failure to evaluate the safety, tolerability, pharmacokinetics, and~     efficacy of multiple ascending doses of Bendavia™ (MTP-131) intravenous infusion.~   "
90046|NCT02388516|"~     There is a growing body of data suggesting that vitamin D modulates the host's immune~     response to acute respiratory infection (ARI). The primary aim of this study is to determine~     whether maternal vitamin D3 supplementation versus placebo decreases the incidence rate of~     microbiologically confirmed viral-associated ARI among infants in Dhaka, Bangladesh.~     Secondary outcomes include: A) incidence of ARI associated with specific major pathogens, B)~     incidence of clinical ARI (without the need for positive microbiology), and C) quantitative~     density of pneumococcal carriage. Infants will be followed from birth until 6 months of life.~     Among infants who meet at least one of the specific case definitions for ARI (see 'Detailed~     Description' section), nasal swab specimens will be collected. Respiratory samples will be~     analyzed by real-time polymerase chain reaction (qPCR) to identify a 7-virus panel (influenza~     A and B, respiratory syncytial virus, human metapneumovirus, adenovirus, and parainfluenza~     types 1, 2, and 3) plus quantitative density of S. pneumonia.~   "
90047|NCT02388503|"~     This study is designed to identify the minimal effective tested dose of fruit extract~     consumed with a bread which provides a reduction in venous post-prandial blood glucose~     compared to a reference bread.~   "
90048|NCT02388490|"~     This is an open-label, non-randomized, multi-center, phase II trial of brentuximab vedotin to~     evaluate ORR primarily in patients with EBV- and CD30-positive lymphomas.~   "
90049|NCT02388477|"~     The purpose of this study is to examine healing after rotator cuff repair in subjects either~     treated with Doxycycline or placebo post-operatively.~   "
90050|NCT02388464|"~     This is a Phase 1, single-center, randomized, double-blind, single ascending dose,~     placebo-controlled study, in subjects aged 45-80 years with stable mild to moderate heart~     failure due to left ventricular systolic dysfunction, to evaluate the safety, tolerability,~     and pharmacokinetics of escalating single intravenous infusion doses of Bendavia™ (MTP-131).~   "
90051|NCT02388451|"~     15 subjects conforming to inclusion and exclusion criteria with a known clinical diagnosis of~     MCI and who provide informed consent will undergo cognitive and functional assessment to~     confirm the diagnosis of MCI. Baseline assessment using the Mindstreams Mild Cognitive~     Impairment Computerized Assessment Battery will be performed. Subjects will then participate~     30 twice weekly meetings of 90 minutes duration each (for a total of 15 weeks). Mindstreams~     testing will be repeated after 15 sessions and at completion of the study.~   "
90052|NCT02388438|"~     This study evaluates the demineralized bone matrix in Hallux valgus.~   "
90053|NCT02388412|"~     Recently, positron emission tomography(PET) using 18F-Sodium fluoride (NaF) showed promising~     results for detecting vulnerable plaques in some pilot studies.~      In this study, the investigators will evaluate the diagnostic accuracy of 18F-NaF PET for~     non-invasively detecting vulnerable plaque, diagnosed by optical coherence tomography (OCT).~   "
92407|NCT02357615|"~     The purpose of this study is to compare nifedipine controlled-release (CR) tablets (Xin Ran)~     with nifedipine controlled-release tablets (Adalat）in the treatment of Early Morning Blood~     Pressure and Central Arterial Pressure.~   "
90054|NCT02388399|"~     In this study, the investigators sought to evaluate the feasibility of estimating external~     hemodynamic stress acting plaque with the use of invasively measured hemodynamic data from~     pressure wire pullback tracing.~      In addition, the investigators will also evaluate detailed plaque geometry and vulnerability~     using optical coherence tomography along with the hemodynamic stress.~   "
90055|NCT02388386|"~     The investigators aim to develop a novel and wireless method for monitoring medication~     adherence among heart failure patients with left ventricular assist devices (LVADs). Proteus~     Digital™ has developed an ingestible and bio-absorbable micro-sensor as a strategy to monitor~     medication compliance. The edible sensor has at its core a silicon-based integrated circuit~     measuring 1.0 mm x 0.45 mm and is imbedded on a pill. Once ingested, this circuit is~     activated by gastric acid resulting in an electrochemical redox reaction and an electrical~     charge that is transmitted to a patch worn over the abdomen and wirelessly to a portable~     device such as a smart phone. This strategy of medication adherence differs from conventional~     adherence monitoring including pill counting and patient-recall by precisely tracking~     medication ingestion.~   "
90056|NCT02388373|"~     The aim of this study is to compare two licensed asthma inhalers and to then evaluate the~     safety of reducing treatment when patient's asthma is in control. The inhalers used in this~     study are the Seretide® 250 Evohaler®, which is widely used in UK, and a recently licensed~     inhaler called Flutiform®. National guidelines recommend that asthma medication should be~     increased when patients are experiencing worsening of their asthma, and reduced when asthma~     is in control. However, it is likely that in daily clinical practice some patients are~     over-treated. It is therefore necessary to conduct more studies which demonstrate that~     reducing treatment dosage can be done safely.~      This study has two phases. In the first phase the investigators aim to recruit 224 patients~     through approximately 40 clinics in the UK and Ireland. One third of these patients will be~     selected in random to use the high dosage Seretide® 250 Evohaler® and two thirds will use~     high dose Flutiform® 250 inhaler for 12 weeks. At the end of phase 1 the investigators will~     compare how well asthma was controlled between the two groups.~      After phase 1 those patients who used Flutiform and did not have any problems with their~     asthma can participate in phase 2. In phase 2 half of the patients will stay on high dosage~     Flutiform 250 and half will be switched to the medium dosage Flutiform 125 inhaler. At the~     end of phase 2 the investigators will compare asthma control between the two groups.~      This study will be conducted by Research in Real Life Ltd (Cambridge, UK) with partial~     funding from Napp Pharmaceuticals Ltd. The estimated total duration of the study is 18 months~     and each patient will spend a maximum of 6 months in the study.~   "
90057|NCT02388360|"~     The purpose of this study is to determine the influence of topical prostaglandin analog (PGA)~     medication on corneal biomechanical properties in patients undergoing PGA treatment for~     open-angle glaucoma.~   "
90058|NCT02388347|"~     To assess the safety of a single ascending dose of MEDI7836 in healthy adult male subjects~     and healthy adult female subjects of non-childbearing potential.~   "
90059|NCT02388334|"~     Half the MS patients require a natural (non professional) caregiver's support for daily~     living activities and this level of investment increases with the degree of disability.~      The caregiver's role is an essential key factor in the therapeutic alliance between the~     patient and heath professionals. The impact on the natural caregivers' Quality Of Life (QOL)~     and their expectations for the global quality of management are not documented, notably~     because of the lack of adapted tools.~      The aim of the investigators' project is to develop, from the caregivers' point of view, a~     standardized questionnaire evaluating 1) their QOL as related to the disease of the assisted~     and 2) their expectations concerning the global quality of professional management (care,~     coordination, information...).~      1) their quality of life (QOL) as related to the disease of the assisted and 2) their~     expectations concerning the global quality of professional management (care, coordination,~     information...).~      The original tool validated will complete the palette of those that the investigators are~     developing to evaluate the quality of care of MS patients according to different dedicated~     organizations (formal networks or not, focused on the patients or professionals).~   "
90060|NCT02388321|"~     Direct comparison of intranasal sub-dissociative dose ketamine with intranasal fentanyl for~     the treatment of moderate to severe pain in pediatric patients in the emergency department.~   "
90061|NCT02388308|"~     Radiotherapy (RT) is an important treatment for prostate cancer with over 10,000 men~     receiving RT per year in the UK. Prostate RT aims to deliver radiation dose to the prostate~     to kill cancer cells whilst minimizing the dose given to surrounding normal tissues, such as~     the bladder or the rectum. Radiation is delivered in a number of daily treatments which are~     called 'fractions'. The position of the prostate varies each day and during the radiation~     delivery. To accurately aim the radiation the prostate needs to be located before daily~     treatment. Clarity is an ultrasound image guidance system that locates the prostate and~     monitors its position during treatment. Ultrasound does not give a radiation dose, is~     non-invasive, provides fast imaging and can easily visualise soft tissues. Before Clarity is~     implemented the investigators wish to ensure that it can accurately locate and monitor the~     prostate by comparing Clarity with marker-based techniques in 24 patients. Patients receive~     markers as part of other trials which are currently recruiting at The Royal Marsden (for~     example, patients in the DELINEATE trial and the PACE trials receive implanted gold markers~     and patients in the PROSPARE trial have received electromagnetic markers). Patients who have~     received or will be receiving markers as part of other studies will be asked to also to take~     part in this study. This means that there will be no additional intervention for patients as~     a result of this study. Clarity will be considered a safe and effective imaging system if the~     mean and standard deviation of the differences between Clarity measurements and marker~     measurements, of prostate position, are less than 1mm. It is possible that markers will~     influence the Clarity measurements. To find out if this happens, the mean and standard~     deviation of Clarity measurements in a group of 24 patients without markers to the group with~     markers will be compared.~      Primary Aim: To evaluate the accuracy of Clarity ultrasound image guidance system for~     prostate motion estimation during treatment (intra-fraction), by comparison with implanted~     marker-based image guidance techniques.~      Primary Hypothesis: Clarity can be safely used to deliver radiotherapy using similar (within~     1mm) treatment margins to those that would be employed if fiducial markers based image~     guidance techniques were used.~   "
90062|NCT02388295|"~     AZD3241 myeloperoxidase (MPO) inhibitor trial is assessing safety and tolerability,~     randomized trial, in patients with Multiple System Atrophy.~   "
90063|NCT02388282|"~     Dinamic intrinsic PEEP is~   "
90064|NCT02388269|"~     A randomized, sham-controlled, single-centre pilot investigation designed to compare two~     parallel groups, gammaCore®-G (active treatment) and a sham, (inactive) treatment in subjects~     with FGIDs.~   "
90143|NCT02387242|"~     The purpose of this study is to evaluate the bactericidal activity against Mycobacterium~     tuberculosis of standard and high doses of rifampicin. Pharmacokinetics (PK) and Whole blood~     Bactericidal Activity (WBA) will be measured in healthy volunteers following a single dose of~     rifampicin at standard dose (10mg/kg) or at high dose (20mg/kg or 30mg/kg).~   "
90065|NCT02388256|"~     Background:~      Patients who undergo laparoscopic surgical resection of colorectal cancer may experience~     various post-operative symptoms (e.g., pain, nausea and vomiting, and anxiety) and limitation~     of daily activities (e.g., walking capacity). There is also a risk of post-operative~     complications and a prolonged hospital stay due to complications. Patients who underwent~     surgical resection may have experienced chronic pain, anxiety/depression, or diminished~     quality of life. The physical, psychological, and functional aspects of patients' disorders~     imply the necessity of multidisciplinary care, including complementary or traditional~     medicines such as acupuncture. This study aims to assess whether acupuncture treatment,~     combined with an enhanced recovery program after surgery in an inpatient care setting is~     effective than only an enhanced recovery program after surgery.~      Objective:~      To assess the effectiveness and safety of acupuncture combined with an enhanced recovery~     program after surgery to reduce postoperative symptoms and improve functional recovery and~     the patients' quality of life.~   "
90066|NCT02388243|"~     The purpose of the two RCT registered here is to determine whether clinicians trained on the~     Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)-linked brief intervention~     (BI) through the NextGenU.org model of training are able to deliver effective brief~     intervention for risky level of alcohol use. It is one study part of a larger program of~     research.~      The investigators hypothesize that the NextGenU.org model of online training with mentor and~     peer activities is an effective way to train clinicians to deliver the ASSIST-linked brief~     intervention. The investigators hypothesize that eligible participants receiving the brief~     intervention will decrease their alcohol consumption and experienced improved health and~     social outcomes more than those receiving only screening results and written information~     (p<0.05). The investigators hypothesize the level of decrease in alcohol consumption will be~     similar to that of trials conducted in high-income countries (HIC).~   "
90067|NCT02388230|"~     Around 20% of women who receive breast radiotherapy (RT) experience moderate to severe breast~     hardening and shrinkage. These side-effects have been shown to be important factors~     influencing quality of life after breast radiotherapy. It is thought that the likelihood of~     developing these side-effects is related to the presence of underlying genetic differences in~     patients. In order to identify these genetic differences, the severity of side-effects needs~     to be accurately measured. Currently, clinical assessments are conducted by a clinician but~     this is not specific enough to be able to relate development of breast shrinkage and~     hardening to genetic differences. For example, clinical assessment often fails to distinguish~     between hardness due to swelling (known as oedema) and hardness due to generalised~     radiation-induced scarring (known as fibrosis). Ultrasound techniques, however, may be able~     to help quantify and characterise radiotherapy-associated changes in breast tissue allowing~     for better correlation with genetic abnormalities. Once genetic changes can be identified,~     adjustment of breast RT treatments (or add drugs) to help reduce side-effects in women at~     higher genetic risk of side-effects may be possible.~      This study tests the ability of two forms of ultrasound, shear-wave elastography (USE) and~     ultrasound backscatter spectroscopy (UBS), to quantify and characterise breast shrinkage and~     firmness with a view to using these techniques to measure the late side-effects of breast RT~     to study the underlying causes of radiotherapy toxicity.~      Principle research question: Can a new ultrasound technique (shear wave elastography) measure~     radiation-induced side-effects in women who have received breast radiotherapy?~   "
90068|NCT02388217|"~     The objective of the current study is to prospectively assess the effect of cannabis on pain~     and functional outcomes in a large group of patients with chronic pain.~   "
90069|NCT02388204|"~     Although DBS improves patient's quality of life advanced Parkinson's patients (PD) by~     addressing the cardinal symptoms and reducing levodopa motor complications, symptoms still~     worsen over time. Postural problems, frequent falls, freezing of gait impairment and other~     locomotion difficulties still remain as important causes of disability and incapacity. Novel~     therapeutics approaches are needed to restore quality of life (QoL).~      This study aims to explore the effects of spinal cord stimulation in locomotion, falls and~     freezing of gait in advanced PD patients.~      Twenty PD patients will undergo thoracic spinal cord stimulation at high frequencies in a~     prospective study for six months.~      Changes in locomotion capacity and freezing of gait rating will be the primary out come.~     Secondary outcomes will be: QoL and common motor outcome measures in PD patients. Always~     comparing the status before, one, three and six months after stimulation was initiated. A~     double blind trial will be performed within three months of follow up (high X low frequency~     stimulation).~   "
90070|NCT02388191|"~     The purpose of this study is:~        1. To evaluate whether 550 mg of naproxen sodium reduces pain scores with IUD insertion on~          a 0-10cm visual analogue scale compared to placebo (primary outcome).~        2. To evaluate whether 550 mg of naproxen sodium reduces pain scores with tenaculum~          placement, uterine sounding and post-procedurally on a 0-10 cm visual analog scale~          compared to placebo (secondary outcomes).~        3. To establish if prophylactic naproxen sodium is acceptable for routine use prior to IUD~          insertion.~      Hypothesis: The administration of naproxen sodium, 550mg orally, 1 hour prior to IUD~     insertion will lead to a reduction in pain scores associated with IUD insertion compared to~     placebo.~   "
90071|NCT02388178|"~     This is a double blind, cross-over, controlled clinical trial utilizing thirty (30) adults to~     evaluate remineralization of early caries lesions.~   "
90072|NCT02388165|"~     The purposes of the clinical trial are to determine whether the SA4Ag vaccine can prevent~     postoperative Staphylococcus aureus infections in patients who are undergoing elective spinal~     fusion surgery, and to evaluate the safety of SA4Ag in patients who are undergoing elective~     spinal surgery.~   "
90073|NCT02388152|"~     The purpose of this study is to determine if multiple immunizations with Lu AF20513 is~     tolerable and safe in patients with mild Alzheimer's disease.~   "
90074|NCT02388139|"~     Aims~        -  assessment of renal artery stenosis incidence in consecutive AMI patients included in~          the Romanian National Programme of Primary Percutaneous Revascularisation;~        -  generating a cardio-renal-metabolic profile in patients with renal atherosclerotic~          disease;~        -  creating a local registry (based on European CARDS percutaneous interventional~          registries) which also includes renal, metabolic and vascular data;~        -  reporting long-term follow-up data on major cardiac adverse events (MACE) in the study~          group.~   "
90075|NCT02388126|"~     Prostate cancer has been the most common neoplastic disease in men in Finland over the last~     ten years. Prostate-specific antigen (PSA) plays an important role in screening of prostate~     cancer. However, PSA has a limited sensitivity and specificity for prostate cancer detection.~     Commonly, the diagnosis of prostate cancer is done by transrectal ultrasonography (TRUS)~     guided biopsy. Because of the low accuracy of TRUS a systematic biopsy is usually performed~     instead of targeted TRUS biopsy. While, as many as 47% of the ultra-sound guided biopsies may~     be false negative and biopsies carry a risk of increase in complications, there is an~     increasing interest in developing more accurate non-invasive imaging modalities.~      This study will enroll 150 men with previous negative biopsies and clinical suspicion of~     prostate cancer due to serum level of PSA higher than 2.5 ng/ml or abnormal digital rectal~     examination (DRE) or patients in active surveillance due to low risk prostate carcinoma.~     Anatomical magnetic resonance imaging (MRI) and diffusion weighted imaging (DWI) at 3 Tesla~     (T) magnetic field using surface coils will be used to non-invasively predict the presence or~     absence of prostate cancer. In addition to routine 12-core TRUS biopsies, targeted TRUS~     guided biopsy based on MRI findings will be performed.~   "
90076|NCT02388113|"~     This study will compare two interventions with the same exercise intensities and caloric~     expenditure but with different exercise frequency, on metabolic control and other risk~     factors in individuals with type 2 diabetes.~   "
90077|NCT02388100|"~     This pilot study is planned to validate the comparability of HbA1c results obtained from~     whole blood collection via venous phlebotomy versus a capillary collection of whole blood.~     The participant will self-collect capillary blood into HbA1c prep vials containing a buffer;~     these prep vials will be sent to the CBL at ambient temperature via US Postal System (USPS)~     mail. The feasibility of self-collection of these capillary samples by GRADE participants~     will also be evaluated.~   "
90078|NCT02388087|"~     The purpose of the study is to investigate the efficacy of the ROX coupler in treating~     patients with tilt test proven Neurally mediated syncope.~   "
90079|NCT02388074|"~     This is a single center study to assess the efficacy of CyPath® Early Detection Lung Cancer~     Assay to detect lung cancer cells from deep lung sputum.~   "
90080|NCT02388061|"~     Patients presenting to the emergency department with acute ischemic stroke, who are are~     eligible for standard intravenous tPA therapy within 4.5 hours of stroke onset will be~     assessed for major vessel occlusion to determine their eligibility for randomization into the~     trial. If the patient gives informed consent they will be randomised 50:50 using central~     computerised allocation to intravenous alteplase or tenecteplase before all participants~     undergo intra-arterial clot retrieval. The trial is prospective, randomised, open-label,~     blinded endpoint (PROBE) design.~   "
90081|NCT02388048|"~     A clinical study to evaluate a treatment with two drugs, named Ofatumumab and Ibrutinib, in~     patients with lymphoblastic acute leukemia who have been already treated with other~     therapies.~   "
90082|NCT02388035|"~     Spontaneous bacterial peritonitis (SBP) is a serious complication in cirrhotic patients, and~     the changes in the microbiological characteristics reported in the last years are impacting~     the choice of antibiotic used in the treatment. Cefotaxime has been the most extensively~     studied antibiotic for this infection. It is considered to be one of the first choice~     antibiotics because of low toxicity and excellent efficacy. Treatment of SBP by intravenous~     cefotaxime should be administered for a minimum 5 days. Antibiotic-resistant microorganisms~     have been increasingly reported especially to cefotaxime and its effect on the clinical~     outcome in treating SBP.~   "
90083|NCT02388022|"~     The purpose of the study is to gather clinical and radiographic outcome data from patients~     who have undergone treatment with an expandable interbody spacer.~   "
90084|NCT02388009|"~     This is a phase I, single-blind, randomized, placebo-controlled, single-center study in~     healthy subjects using a staggered approach to dosing.~      30 subjects will be randomized to receive 10 μg Flexyn2a candidate vaccine with or without~     adjuvant or placebo.~   "
90085|NCT02387996|"~     The purpose the study is to measure the effect of nivolumab (BMS-936558) in reducing tumor~     size in subjects with metastatic or unresectable bladder cancer.~   "
90086|NCT02387983|"~     The purpose of this study is to evaluate the pharmacokinetics and safety of oral posaconazole~     tablets in Chinese participants at high risk for invasive fungal infections. Neutropenic~     participants undergoing chemotherapy for acute myelogenous leukemia or myelodysplastic~     syndromes will be enrolled in the study.~   "
90087|NCT02387970|"~     Dental implants are a widely used treatment option for the replacement of lost teeth due to~     trauma or oral diseases. The original protocol for placement of dental implants in edentulous~     spaces in the maxilla or the mandible was introduced more than thirty years ago and called~     for a two-stage approach, i.e., surgical placement of submerged dental implants and~     subsequent uncovering with abutment connection, prosthesis fabrication and functional loading~     approximately 6 months after. Today, the time between surgery and loading in a two-stage~     protocol has been commonly abbreviated to 3-4 months, while immediate implant~     provisionalization has emerged as a reliable and predictable option in cases of adequate~     osseous support, having similar survival and success rates to the two-step procedure.~     Comparison of histological healing has demonstrated no significant differences in bone to~     implant contact between implants surgically placed according to a two-stage protocol and~     those immediately provisionalized. However, substantial variability was noted among the~     clinical protocols used in the studies carried out so far, and additional well-designed~     randomized controlled trials (RCTs) are needed to fully appreciate the clinical outcomes of~     immediate and early loading protocols.~      The design of dental implants is a subject of continuous improvement, and implant~     manufacturers regularly introduce new products the use of which may result in accelerated~     soft and hard tissue healing, increased initial implant stability, and enhanced esthetic~     outcomes. The purpose of this randomized, controlled trial is to compare treatment outcomes~     when using a newly-introduced dental implant (NobelParallel™ CC) in a one-stage or a~     two-stage protocol. This new implant has the same titanium oxide surface coating (TiUnite®)~     and the same design principles of the parallel-walled NobelSpeedy Groovy™ implants, and an~     internal conical connection. The implant is marketed under the premarket notifications~     K050406 and K073142 (510(k), Food and Drug Administration).~   "
90088|NCT02387957|"~     To evaluate the safety of intravitreal (IVT) Fovista® administered in combination with~     anti-VEGF therapy.~   "
90089|NCT02387944|"~     The purpose of this study is to assess coagulation and platelet function in children with~     congenital heart disease, measured with a bedside device (thromboelastometry and impedance~     aggregometry).~      The investigators also aim to determine if this device detect post-cardiopulmonary bypass~     clotting derangements and may help to manage bleeding in this population.~   "
90090|NCT02387931|"~     The purpose of this study is to determine whether dietary supplementation with Vitamin D or~     Fish Oil can help to reduce physical and emotional symptoms in adolescent girls with~     endometriosis.~   "
90091|NCT02387918|"~     Tonsillectomy is one of the most frequently performed surgical procedures in children. It~     remains associated with a high morbidity related to postoperative vomiting (POV), pain, risk~     of bleeding, and dehydration due to impaired oral intake. Current medications for POV have~     limited efficacy and may even be associated with potential side-effects. Non-pharmacological~     techniques such as acupuncture has been investigated as alternatives to antiemetics and as~     additional treatment modalities for POV.~   "
90092|NCT02387905|"~     The goal of this clinical research study is to learn whether using body cement on the largest~     part of the vertebra (a procedure called vertebral body cement augmentation) can help to~     prevent a fracture following stereotactic spinal radiosurgery. Researchers also want to learn~     if the procedure can lessen pain and improve quality of life in patients receiving this~     surgery.~   "
90093|NCT02387892|"~     This study is being done to test if adding vitamin D to cheese and yogurt products will help~     children further improve their vitamin D intake. All children will be given a six month~     supply of the milk products. One group will receive yogurt and cheese products already sold~     in stores, while the other group will receive yogurt and cheese products with added vitamin~     D. This will show if milk products with added vitamin D help maintain vitamin D intake and~     child health.~      The investigators are asking children 2 through 8 years old to participate. Children must not~     have any medical conditions that affect their bones or vitamin D levels. They must not be~     taking vitamin D supplements or medications that affect bone. This study will last for 6~     months. The investigators expect 60 children from the Montreal area will participate in this~     study.~      Children will be randomly placed in one of the two study groups. There will be an equal~     number of children in each group. All groups will go through the exact same procedures during~     the study; the only difference between groups will be the amount of vitamin D in the milk~     products they will consume each day. Families will not know which group their child is in~     until the study is complete. Children will continue to drink their regular milk at home and~     the investigators will provide flavoured yogurts and cheese to eat every day for the entire 6~     month study. Families will be given a fresh supply of the yogurt or cheese products every 4~     weeks along with instructions.~      There are 3 study meetings for the parent and child to attend which take place at the Mary~     Emily Clinical Nutrition Research Unit. The clinic is located on the Macdonald Campus of~     McGill University in Ste. Anne-de-Bellevue, QC. The first visit is at the start of the study,~     the second is at the end of 3 months and the last visit is at the end of the 6 month study.~   "
90094|NCT02387879|"~     CC-5013-PASS-TR/A non-interventional, multi-center, observational post authorization safety~     study of patients with relapsed/refractory multiple myeloma treated with Lenalidomide in~     Turkey.~      The study is anticipated to last for approximately 8 years. Recruitment period will continue~     until 500 subjects have commenced the third cycle of treatment with lenalidomide.~   "
90095|NCT02387866|"~     This is a single ascending dose, open-label study that will evaluate the pharmacokinetics and~     safety of the AG-221 compound in normal, healthy volunteer male subjects (both Japanese and~     Caucasian).~   "
90096|NCT02387853|"~     An international, multi-centre, prospective, open-label, non-controlled, single-group, 4-week~     trial in adolescent subjects with plaque psoriasis.~   "
90097|NCT02387840|"~     This study will look at the feasibility of using magnetic resonance fingerprinting (MRF) in~     children, adolescents and young adults (AYA) with and without brain tumors. This study will~     also look at subjects with and without neurofibromatosis type 1(NF1), a genetic disorder that~     affects the growth of nervous system cells. Further, it will explore potential ways of using~     of MRF signal measurements in children, adolescents, and young adults with brain tumors,~     including tissue characterization, looking at whether the treatment was effective, and~     finding metastasized tumors of unknown origin (occult tumors). To explore the feasibility and~     potential applications of MRF, this study will recruit up to 80 subjects but will stop once~     10 subjects have usable data in each of six groups.~   "
90098|NCT02387827|"~     The purpose of this present study is to determine if a daily walking program of 50 continuous~     minutes (long bout) or two 25-minute bouts (short bouts) in similar volume on body weight,~     abdominal fat mass deposition and cardiometabolic measures in overweight and obese women~     receiving a low calorie diet for 24 weeks.~   "
90099|NCT02387814|"~     The study involves a single dose of a study drug called abemaciclib taken by mouth. The~     purpose of this study will be to measure how much study drug gets into the blood stream and~     how long the body takes to get rid of it when given to participants with mild, moderate, or~     severe liver impairment compared to healthy participants. In addition, the tolerability of~     the study drug will be evaluated.~      This study will last approximately 3 weeks for each participant, including check-in and~     follow-up.~   "
90100|NCT02387801|"~     To detect onset of activity of ixekizumab in participants with moderate-to-severe plaque~     psoriasis and to document the same using sequential photographic images.~   "
90101|NCT02387788|"~     Phase 2a open-label study to assess the efficacy and safety of subcutaneous 15mg AKB-9778~     administered twice daily for 84 days in subjects with macular edema due to RVO.~   "
90102|NCT02387775|"~     This is a prospective, interventional study aiming to assess the effectiveness of the~     Esophageal Cooling Device (ECD) as a temperature control modality in post cardiac arrest~     patients. In addition, observed adverse events during ECD use, ease-of-use, nurse~     satisfaction and patient outcomes will be examined.~   "
90103|NCT02387762|"~     This study is evaluating the safety, pharmacokinetics (PK), pharmacodynamics (PD) and~     efficacy of ACP-196 in subjects with Rheumatoid Arthritis on background Methotrexate.~   "
90104|NCT02387749|"~     A debilitating consequence of diabetes mellitus (DM) is neuropathy which globally affects~     between 20 -30% of diabetic patients and up to 50% in other studies. The incidence of~     diabetic neuropathy (DN) is estimated to be up to 45% for type 2 diabetic patients and 59%~     for type 1diabetic patients in USA.(DN) is the most common complication of DM.The~     pathophysiology of DN is promoted by several risk factors: micro vascular disease, neural~     hypoxia, and hyperglycemia-induced effects.At the molecular level, the primary cause of~     diabetic complications is known to be hyperglycemia, which disrupts cellular metabolism by~     the formation of reactive oxygen species (ROS).In the aspect of nerve functions, ROS~     formation increases neuron's susceptibility to damage. In addition, hyperglycemia impedes~     production of angiogenic and neurotrophic growth factors, which are necessary for normal~     function of neurons and glial cells and maintenance of vascular structure.No definitive~     disease-modifying treatments have been to reverse DN. The current treatment focuses on tight~     glycemic control which can reduce potential risk factors for further nerve damage and~     DN-associated pain management.In many studies, deficiency of neurotrophic factors and lack of~     vascular support have been regarded as key factors in the development DN.Mesenchymal stem~     cells (MSCs) are particularly attractive therapeutic agents because of their ability to~     self-renew, differentiate into multi lineage cell types, and locally secrete angiogenic~     cytokines, including basic fibroblast growth factor (bFGF) and vascular endothelial growth~     factor (VEGF) .These factors were reported to prompt neovascularization and have support for~     neural regeneration.It was plausible that MSCs may also be an effective therapeutic agent for~     the DN treatment through the paracrine effects of bFGF (Shibata et al., 2008) and VEGF and~     their potential to differentiate into neural cells such as astrocytes, oligodendrocytes , and~     Schwann cells.The adherent nature of MSCs makes them easy to expand in culture and an~     attractive candidate to use in cell therapy.Therefore, cell therapy has recently emerged as~     an attractive therapeutic strategy to meet the needs of both neurotrophic and vascular~     deficiencies of DN.Proper diagnosis of DN depends on the pattern of sensory loss, reflex~     test, electrodiagnostic studies, and imaging~   "
90105|NCT02387736|"~     Standard one-year dialectical behaviour therapy (DBT), which has four components, is an~     effective treatment for people with borderline personality disorder. However, such DBT~     programs are in short supply and costly, resulting in long wait lists. In practice, DBT is~     often reduced in length or intensity. This study will determine whether shorter DBT treatment~     is clinically effective and cost-effective. In total, 240 self-harming BPD patients will be~     randomly assigned to receive either 1 year or 6 months of DBT, with follow-up lasting two~     years. Rates of suicidal and self-harm behaviours, use of health care and general~     psychological functioning will be examined.~   "
90106|NCT02387723|"~     The present aim is to perform at small clinical safety trial in heart failure patients with~     allogeneic adipose tissue derived mesenchymal stem cells.~   "
90107|NCT02387710|"~     Obstructive sleep apnea (OSA) is common and has major health implications but treatment~     options are limited. Interestingly, the severity of OSA is profoundly reduced in deep sleep~     (called slow wave sleep), potentially via an increase in the stimulus required to arouse~     from sleep. Here the investigators test the idea that the medication called tiagabine~     improves slow wave sleep and reduces OSA severity. The investigators will also test whether~     tiagabine raises the arousal threshold (more negative esophageal pressure), and whether~     detailed OSA phenotyping characteristics can predict the improvement in OSA severity with~     this intervention.~   "
90108|NCT02387697|"~     The purpose of this study is to assess the efficacy and safety of implanting an Edwards~     Sapien XT Valve into the vena cava inferior (VCI; between right atrium and the hepatic vein)~     on clinical variables, exercise tolerance and well being in patients with severe tricuspid~     regurgitation and signs of right heart failure.~   "
90109|NCT02387684|"~     The most important method to slow down and stop the liver disease progression in patients~     with chronic hepatitis B is antiviral therapy, by which to achieve maintaining viral response~     during treatment or obtain sustained viral response after treatment. The aim of the therapy~     with interferon is make patients obtain immune control to HBV defined as sustained viral~     response after treatment, however, most patients can't get this target after 48 weeks of~     interferon treatment, and some patients need extended treatment in clinical practice to~     enhance the rate of sustained viral response or HBsAg loss occurred during treatment. In this~     cohort study, the efficacy of extended therapy of interferon in HBeAg negative chronic~     hepatitis B patients will be evaluated.~   "
90110|NCT02387671|"~     The long-term goal of this research is to develop, evaluate and implement effective mHealth~     technology interventions that improve cancer management outcomes by changing lifestyle~     behaviors among urban health- disparity facing populations. To accomplish this goal, the~     investigators will need to determine the feasibility and preliminary efficacy of an~     intervention in which breast cancer survivors receive counseling about lifestyle behaviors~     (weight, nutrition, and physical activity) from a health counselor trained in evidenced-based~     behavioral counseling methods.~   "
90111|NCT02387658|"~     1. To perform an observational analysis to determine if mean translesional gradient~          measurements (TLG) are associated with differences in clinical outcomes in patients with~          femoropopliteal arterial disease and claudication.~        2. Hypothesis: Patients stratified by a residual translesional gradient </= 11 mmHg after~          peripheral revascularization or angiography alone will have better clinical outcomes~          than patients with TLG > 11 mmHg as assessed by six minute walk (6MW), walking~          impairment questionnaire scores (WIQ), ankle brachial index and need for repeat~          procedure at 6 months.~   "
90112|NCT02387645|"~     The current pilot study aims at answering the scientific question, whether exfoliated cells~     from Endometrium Carcinoma (EC) can be detected in the lavage fluid from the uterine cavity~     and proximal fallopian tubes with the same sensitivity as in specimen from liquid-based~     cervical cytology. If this turns out to be the case, earlier detection, particularly of type~     II EC should be possible.~   "
90113|NCT02387632|"~     Humidified High Flow Nasal Cannula (HHFNC) is a new modality of respiratory support for~     children with respiratory failure. Despite its extensive use in pediatric and adult~     population, the exact mechanism of work of HHFNC is not fully explained.The objective of the~     investigators' research project is to determine the relationship between the amount of airway~     pressure that can be delivered at specific flow levels of HHFNC. This information will allow~     the investigators to use HHFNC in a much more informed and safe manner.~   "
90114|NCT02387619|"~     A randomized, open-label, multiple-dose, crossover study to investigate the pharmacokinetic~     drug interaction between rosuvastatin and telmisartan/amlodipine in healthy male volunteers~   "
90115|NCT02387606|"~     The purpose of this study is to evaluate the antiviral effect of repeated oral dosing of JNJ~     53718678 compared to placebo in healthy adult participants infected through inoculation with~     respiratory syncytial virus (RSV)-A Memphis 37b virus.~   "
90116|NCT02387593|"~     Colorectal cancer (CRC) is one of the leading causes of cancer death worldwide. The~     cumulative risk of developing CRC is about 6% lifelong.~      The benefit of screening colonoscopy depends on the detection and removal of all adenomas,~     however, some of these may be difficult to detect.~      The endocuff (EC) is a polymer sleeve which joins the tip of the colonoscope to improve the~     image viewing of the mucosa during colonoscopy procedure.~      There is insufficient evidence of the usefulness of endocuf~   "
90117|NCT02387580|"~     This is a single-centre, 2-part, randomised, single-dose parallel group study in healthy male~     subjects and female subjects of non-childbearing potential.~   "
90118|NCT02387567|"~     The purpose of this study is to investigate the effects of a treatment involving the~     application of lidocaine injected on the low back area for pain control. The study will~     compare this form of treatment with other options such as physical exercises or pain killer~     medication, different measurements are going to be used to quantify the response to each of~     these treatments.~   "
90119|NCT02387554|"~     The purpose of this study is to investigate the pharmacokinetic interaction and safety~     between HGP0904, HGP0608 and HGP1405 when administered alone and in combination in healthy~     male volunteers~   "
90120|NCT02387541|"~     To investigate the effects of total knee replacement is harmful to Postoperative cognitive~     dysfunction~   "
92526|NCT02356042|"~     The study aimed to compare the changes in health and functional status between nursing home~     residents practicing GIA activity and a control group of residents, and to examine the~     changes in residents' abilities to participate in GIA activity.~   "
90121|NCT02387528|"~     High demands put on workers nowadays have contributed for an increase on the vulnerability~     and the stress levels, with severe consequences for the health (Sandim, 2008). One of the~     main health conditions today is the Burnout Syndrome - or professional exhaustion (Salanova~     and Llorens, 2008), with harmful consequences for individuals and organizations. The level of~     dedication to the tasks in which the frustrations are faced more strongly can determine what~     type of burnout would be developed ( frenetic, under-challenged or worn-out), affecting~     the health condition. In late 1970s, mindfulness began to be studied as a behavioral~     intervention in mental health. Current evidence suggests that the state / mental trait~     mindfulness is positively associated with a variety of mental health indicators. The~     potential applicability of mindfulness in health services is great. Besides the effects for~     patients, health professionals also can have benefits. The consensus is that a greater number~     of mental health interventions need to be evaluated and implemented and it is possible that~     mindfulness can fit this need as a new technology in health care. There is a gap in the~     literature on the relationship of different clinical types of burnout and its association~     with different psychological constructs related to health, particularly in relation to the~     mental state of mindfulness and, in particular , addressing health professionals. Better~     understand this association will enable the improvement of existing and development of new~     interventions, geared to the specific needs of the population of health professionals,~     especially for professionals of Primary Health Care (PHC) , the object of this study. Thus,~     the general objective of this study is to assess the effect of a mindfulness-based~     intervention for primary health care professionals in the city of Porto Alegre, evaluating~     the behavior of a questionnaire for clinical subtypes of burnout (BCSQ -36), other variables~     of psychological well -being, depression and anxiety symptons, activity and sleep patterns,~     measuring before and after the intervention, from a randomized controlled trial.~   "
90122|NCT02387515|"~     This clinical pilot trial will investigate the effects of technology-supported exercise~     therapy for chronic non-specific low back pain. Patients will follow an intensive~     rehabilitation program (2x/week for 18 weeks), with emphasis on motor control training that~     is supported by technology. The technological system consists out of motion tracking sensors~     that register the movements and position of the lumbar spine.~   "
90123|NCT02387502|"~     Tracheal intubation requires alignment of oro-pharyngeal-laryngeal axes. When these three~     axes are not aligned, intubation becomes difficult. In the researchers' study, the~     investigators simulated difficult laryngoscopy situation by using a rigid neck collar. This~     neck collar renders intubation difficult not only by restricting neck movement, but also~     reducing mouth opening. The investigators compared the performance of Macintosh, MacCoy and~     Airtraq laryngoscope in simulated difficult laryngoscopy using a rigid neck collar.~   "
90124|NCT02387489|"~     The purpose of the study is to examine the comparative effectiveness of a computerized brief~     intervention vs. an in-person brief intervention delivered by a nurse in reducing marijuana,~     alcohol, and sex risk behaviors in adolescents receiving services in school-based health~     centers.~   "
90125|NCT02387476|"~     This will be a prospective study in subjects with Obstructive Sleep Apnea (OSA) to~     characterize the clinical performance during a single night of therapy with a FRESCA mask~     compared with a single night of therapy with their existing nasal Continuous Positive Airway~     Pressure (CPAP) mask.~   "
90126|NCT02387463|"~     The most important method to slow down and stop the liver disease progression in patients~     with chronic hepatitis B is antiviral therapy, by which to achieve maintaining viral response~     during treatment or obtain sustained viral response after treatment. The aim of the therapy~     with interferon is make patients obtain immune control to HBV, in clinical practice, it was~     expressed as HBeAg seroconversion, HBsAg loss and sustained viral response in HBeAg positive~     patients. However, those targets can't be get in most patients by 48 weeks of interferon~     treatment, and some patients need extended treatment to enhance the rate of HBeAg~     seroconversion and HBsAg loss. In this cohort study, the efficacies of extended therapy of~     interferon in HBeAg positive chronic hepatitis B patients will be evaluated.~   "
90127|NCT02387450|"~     Sildenafil has shown potential effects both on vasodilator mechanisms and as an inhibitor of~     the NO/GMPc Pain activation. The investigators aim at estimating the benefit of sildenafil in~     term of morbi-mortality in patients with arterial claudication on a multicenter prospective~     double blind study.~   "
90128|NCT02387437|"~     Acute respiratory distress syndrome (ARDS) is the common disease in clinical, which~     pathophysiology is a lot of alveolar collapse and heterogeneity. Recruitment maneuver is one~     of the important therapy for improvement of this phenomenon. The previous research focuses on~     the hemodynamic and oxygenation effect of recruitment maneuver on the lung of ARDS. Seldom~     investigators try to find the intuitive change of heterogeneity when recruitment maneuver is~     implemented. In this study, the investigators compare three recruitment maneuvers on the lung~     heterogeneity of ARDS.~   "
90129|NCT02387424|"~     Pregnant women with histories of depression are at high risk of depressive relapse/recurrence~     during the perinatal period, and options for relapse/recurrence prevention are limited.~     Mindfulness-based cognitive therapy (MBCT) has strong evidence among general populations but~     has not been studied among at risk pregnant women.~      This study is the second phase of a multi-phase project adapting MBCT for perinatal women~     (MBCT-PD).~   "
90130|NCT02387411|"~     Chronic heart failure (CHF) is a clinical syndrome presented with central, cardiac~     deterioration as well as peripheral vascular and muscular abnormalities, resulting finally to~     reduced exercise tolerance, quality of life and mortality rates. Exercise training is a major~     component of rehabilitation / secondary prevention interventions, inducing significant~     beneficial changes in mechanisms of pathophysiology, exercise tolerance, functional capacity~     and quality of life, while a positive impact on hospitalization and mortality reduction~     should not be also excluded. There has been growing interest in the characteristics and~     modalities of exercise training able to induce optimal benefits. High intensity and interval~     mode have been shown to induce greater benefits than moderate intensity and continuous mode~     regimes. Additionally, there has been sound rationale for the inclusion of strength training,~     which has been also shown able to yield benefits in terms of exercise capacity and quality of~     life. However, there haven't been much data on the so called combined regimes, which include~     both aerobic exercise and strength training. This study aims at investigating the effects of~     combined high-intensity interval and strength training compared to high-intensity interval~     exercise alone in CHF.~   "
90144|NCT02387229|"~     This is a prospective, multicenter, randomized, double-blinded clinical trial exploring the~     efficacy and safety of rivaroxaban as compared to acetylsalicylic acid in reducing stroke,~     transient ischemic attack (TIA) and neurocognitive decline, in subjects with non-valvular AF~     and with low risk of stroke.~   "
90145|NCT02387216|"~     The purpose of this study is to determine whether the combination of MM-121 plus docetaxel is~     more effective than docetaxel alone in regards to PFS in patients with heregulin-positive~     NSCLC.~   "
90131|NCT02387398|"~     This study is a pilot, multi-centered, randomized, clinical trial to evaluate the safety and~     efficacy of performing early Coronary Angiography (CAG) versus no early CAG in post-cardiac~     arrest patients without ST segment elevation. Safety will be assessed by evaluating the~     association of major adverse events (re-arrest, bleeding, pulmonary edema, hypotension, acute~     renal insufficiency, and pneumonia) with early coronary angiogram. Efficacy will be assessed~     by a composite endpoint of improved left ventricular regional and global function (both~     regional wall motion analysis and left ventricular ejection fraction) as measured by~     echocardiography prior to hospital discharge and favourable neurological function (Cerebral~     Performance Categories 1 or 2) at discharge.~   "
90132|NCT02387385|"~     Neonatal Encephalopathy is a serious condition arising from unexpected lack of cerebral blood~     flow and oxygen supply to the foetal brain at the time of birth. Every year, approximately~     one million babies die from neonatal encephalopathy in low and middle-income countries and a~     quarter of these deaths occur in India.~      In the past decade, a number of clinical trials in high-income countries has shown that~     cooling therapy along with optimal neonatal intensive care reduces death and neurodisability~     after neonatal encephalopathy. Cooling therapy is now used as a standard therapy after~     neonatal encephalopathy in all high income countries, including the UK.~      Although the burden of neonatal encephalopathy is far higher in low and middle-income~     countries, the safety and efficacy data on cooling therapy from high income cooling trials~     cannot be extrapolated to these settings, due to the difference in population co-morbidities~     and sub-optimal neonatal intensive care.~      The HELIX trial proposes to examine whether whole body cooling to 33.5°C initiated within 6~     hours of birth and continued for 72 hours reduces death or neurodisability at 18 months after~     neonatal encephalopathy in public sector neonatal units in India.~      A total of 408 babies with moderate or severe neonatal encephalopathy will be recruited from~     the participating centres in India over an 18 to 24 month period. The babies will be randomly~     allocated to whole body cooling or usual care. The cooling therapy will be achieved using an~     approved cooling device (Tecotherm) that is already in clinical use in the UK and in India.~     MR imaging and spectroscopy will be performed at 1 week of age to examine the brain injury.~     Neurodevelopmental outcomes will be assessed at 18 months of age. Primary outcome measure is~     death or moderate/severe neurodisability at 18 months.~   "
90133|NCT02387372|"~     The purpose of this study is to evaluate the pharmacokinetics and lung penetration of~     intravenous Ceftolozane/tazobactam in critically ill participants.~   "
90134|NCT02387359|"~     This study in patients with IBS-C is a randomized, double-blind, placebo-controlled,~     parallel-group clinical trial with 12 weeks of study drug therapy.~   "
90135|NCT02387346|"~     The role of the cerebello-thalamo-cortical loop in the generation of tremor, gait impairments~     and postural instability has been made evident. The current study will use a Magstim Rapid 2~     to deliver rTMS with the aim of modulating the activity in the vermal/paravermal region of~     the cerebellum, and consequently the cerebello-thalamo-cortical pathway. Analysis of the~     effects of an acute session of stimulation will be made to determine the therapeutic~     potential of the protocol. Motor symptom improvement will be assessed immediately following~     stimulation to detect motor symptom improvement up to one hour following stimulation,~     providing insight into the effectiveness of the protocol to produce benefits which outlast~     the period of stimulation.~      Participants will each receive one session of stimulation in the ON state of medication. A~     pre-assessment will be performed before beginning the session and a post-assessment will be~     performed immediately following stimulation. There will be two groups, which will both~     undergo the exact same protocol, however one group will receive real stimulation, and one~     group will receive sham stimulation.~   "
90136|NCT02387333|"~     The aim of this clinical trial is to investigate the safety and efficacy of prophylactic mesh~     on prevention of parastomal hernia(PSH) after ileal conduit urinary diversion (IC) in a~     randomized controlled fashion.~   "
90137|NCT02387320|"~     This randomized controlled trial (RCT) in newly-diagnosed breast cancer patients seeks to~     determine the effectiveness of a self-care toolkit on specific symptoms associated with~     surgery as compared to a standard care group.~   "
90138|NCT02387307|"~     This is a multicenter, open-label, phase I study of rSIFN-co (3 times a week via subcutaneous~     injection for 21 days, with 1 week of washout per cycle).~   "
90139|NCT02387294|"~     Immunogenicity and Tolerability Study of Fluval AB Novo Suspension for Injection (trivalent,~     seasonal influenza vaccine, active ingredient content: 6 μg HA/strain/0.5 ml) for Children~     and Adolescents.~   "
90140|NCT02387281|"~     Freezing of gait (FOG) is among the most disabling motor features of Parkinson disease (PD)~     and is present in other forms of parkinsonism as well. FOG is a brief (usually lasting <30~     seconds) episode of absence or a greatly reduced forward movement of the feet despite~     intention to walk. It typically occurs when patients initiate gait (so-called start~     hesitation) and when attempting to turn. It is a leading cause of falls and often results in~     a wheelchair-dependent state. FOG greatly interferes with activities of daily living, causes~     social isolation and poor quality of life.~      FOG is one of the least understood features of PD. It possibly may develop independent of the~     other motor features of the disease, and be caused by specific pathological changes in the~     brain. Previous studies on FOG have shown conflicting information and have not lead to clear~     understanding of the pathophysiology. One key reason for this is that there appears to be~     multiple subtypes which have rarely been taken into account.~      The purpose of this study is to show that different types of FOG exist and to see if there is~     a connection to cognitive differences or gait patterns.~   "
90141|NCT02387268|"~     The Motus GI Colon Cleansing device is intended to facilitate intra-procedural cleaning of a~     poorly prepared colon by irrigating the colon and evacuating the irrigation fluid and feces.~   "
90142|NCT02387255|"~     The main objective of this study is to utilize Magnetic Resonance Elastography (MRE) to~     determine tissue stiffness of abdominal aortic aneurysms (AAA). For patients with AAA, MRE is~     a more sensitive and superior method of determining the risk for rupture of AAA based on~     stiffness estimates when compared to the current, crude method of assessing risk based on~     measurement of the diameter of the aneurysm. The investigators will also validate the~     stiffness estimates against gold standard i.e. mechanical testing and histopathology only AAA~     patients undergoing AAA surgery.~   "
90147|NCT02387190|"~     Pulmonary dysfunction presented in patients with heart failure is observed as a decrease of~     maximal aerobic capacity compared to healthy people. Lung function deterioration manifests,~     in the presence of muscle fatigue and dyspnea on exertion, loss of functional capacity, and~     activities limitation of daily living. Those manifestation influence the perception of~     quality of life of patients1.~      Patients with heart failure need to develop changes in lifestyle and daily activities aiming~     to maintain clinical control and prevent the onset of complications and disabilities. If~     these changes are not often performed, they might carry bigger burden to for the individual~     and their family and for the healthcare system due to increasing of morbidity and mortality~     between those patients2.~      Systematic reviews conducted in developed countries (USA3, UK4 and Canada5) and developing~     countries (Colombia6) have shown that telehealth can produce positive effects in individuals~     with chronic diseases as heart failure. This kind of intervention seems to be effective in~     preventing hospitalizations and non-elective emergency visits.~      In Brazil, telenursing is still a non-standardized and non-diffused intervention. In this~     perspective, telenursing represents soft new tools to provide quality care. It certainly~     allows the orientation and training of patients, the permanence of them at home, reduces~     unnecessary hospitalization. Additionally, this intervention, allows the management of~     nursing time and strengthens their professional autonomy7.~      The principal aim of this study is to describe the protocol to be used in MRE study. The~     objective of MRE trial is to test the hypothesis that telenursing contributes to the~     improvement in lung function over the medium term, in patients with heart failure under~     continuous education.~   "
90148|NCT02387177|"~     The aim of this research is to adapt the NF-specific adult version of the Skype 3RP for use~     with adolescents, and to test its feasibility, acceptability, and preliminary effect in~     improving quality of life, and in decreasing stress and psychological distress.~   "
90149|NCT02387164|"~     The purpose of this study is to evaluate if immune-tolerance with Alum-formulated GAD~     (Diamyd), in combination with high dose Vitamin D3, may delay or stop the autoimmune process~     leading to clinical type 1 diabetes in non-diabetic children with ongoing beta-cell~     autoimmunity as indicated by positive islet autoantibodies.~   "
90150|NCT02387151|"~     This study will test whether selected allogeneic bone marrow derived MSCs are safe by~     assessing the composite end point Biopsy Proven Acute Rejection (BPAR)/ graft loss at 12~     months.~   "
90151|NCT02387138|"~     This study is to determine the Maximal Tolerated Dose (MTD), the Dose Limitant Toxicities~     (DLTs) and the safety profile of S-1 combined with fixed doses of Irinotecan (SIRI schedule)~     and fixed doses of Irinotecan and Oxaliplatin (SIRINOX schedule).~   "
90152|NCT02387125|"~     This is a Phase 1b, open label, multi-center study of CMB305 (sequentially administered LV305~     [a dendritic cell-targeting viral vector expressing the NY-ESO-1 gene] and G305 [NY-ESO-1~     recombinant protein plus GLA-SE]) in patients with melanoma, sarcoma, ovarian cancer, or~     non-small cell lung cancer that express NY-ESO-1.~   "
90153|NCT02387112|"~     The aim of the study is to assess whether, in patients who are listed for cardiac~     transplantation in transplantable (T) status, early implantation of a left ventricular assist~     device is superior to the current therapeutic strategy of medical heart failure therapy and~     assist device implantation only after serious deterioration of the patient's condition.~   "
90154|NCT02387099|"~     The BOLERO-2 study demonstrated a benefit for patients who received everolimus in addition to~     exemestane in patients who progressed during/after a non-steroidal aromatase inhibitor;~      Routine use of everolimus shows an high rate of intolerability due to mucositis/stomatitis~     especially during the first 12 weeks of treatment leading cause for treatment discontinuation~     not related to tumor progression;~      GeparQuinto study (setting III: non-responders): everolimus was given as salvage treatment in~     combination with paclitaxel for patients without response to 4 cycles~     epirubicin/cyclophosphamide with/without bevacizumab.~      A dose-escalation schema was successfully used to improve tolerability of everolimus together~     with the cytotoxic Agent.~      Everolimus plus exemestane has improved the prognosis of metastatic breast cancer~     significantly. Desiree-study aims to improve the tolerability, which is necessary in order to~     achieve an adequate dose intensity for the patients in Routine care.~   "
90155|NCT02387086|"~     The purpose of this study is to determine whether thalidomide can improve the effectiveness~     of the gefitinib in NSCLC patients with EGFR mutations.~   "
90156|NCT02387073|"~     Recently the importance of electrical PRO system is increased for the accuracy, convenience,~     and efficiency for both patients and physicians. For the evaluation of quality of life,~     various self-reported questionnaires is filled-out by the patient, mostly in front of~     outpatient clinic, and doctor usually take times to calculate the score. If there is~     electrical PRO which is available with mobile device, the efficacy of clinic would be~     improved. The investigators developed such a system and applied the system for patients with~     spinal disease. The investigators assessed the effectiveness of application of electrical-PRO~     in outpatients' clinic for patients who had filled-up same questionnaire in paper version.~   "
90157|NCT02387060|"~     Opioid analgesic drugs are the main treatment of patients during anesthesia. Although highly~     effective, their use is not without problems. One is the increasing requirement of these~     address the same nociceptive stimulus.~      Opioid induced hyperalgesia could be an explanation studies in animal models. Through~     mechanisms where N-methyl-D-aspartate receptors, glutamatergic system disturbances and~     changes in intracellular calcium regulation involved.~      The hyperalgesia induced by intrathecal opioids is controversial. The investigators propose a~     model study in patients undergoing cesarean section to study the secondary hyperalgesia~     induced based on the study of nociceptive thresholds with two methods opioids: Von Frey~     filaments and digital algometer.~      If intrathecal fentanyl is used in spinal anesthesia for elective cesarean section, then, an~     increase in sensitivity will occur. This increase can be measured by von Frey filaments,~     expressed in increased requirement clinically opioids.~   "
90158|NCT02387047|"~     The aim of this study is to determine the validity of a self-questionnaire detecting seniors~     phobia of falling living at home. A prospective monocentric observational study compares in a~     blind way the presence of Diagnostic and Statistical Manual of Mental Disorders fourth~     edition (DSM-IV) criteria for specific phobia, considered as the gold standard to the score~     obtained at the detecting questionnaire for ≥70 years old seniors suspected of phobia of~     falling and attending geriatric day hospital at the Bretonneau hospital (APHP, Paris).~   "
90159|NCT02387034|"~     The purpose of this study is to determine whether an intervention with Physical activity on~     prescription (PAP) to individuals in primary care with knee or hip osteoarthritis would~     result in effects on physical activity level, physical capacity and quality on life.~      The hypothesis is that patients with osteoarthritis in hip or knee will increase their level~     of physical activity significantly more with a PAP intervention compared to patients who only~     get general advice about physical activity.~   "
90160|NCT02387021|"~     The purpose of the study is to determine whether the association of sciatic nerve block to~     continuous adductor canal block is effective in the treatment of total knee arthroplasty post~     operative pain .~   "
90161|NCT02387008|"~     Purpose: The goal of guided bone augmentation is to provide an alveolar ridge of sufficient~     dimension to permit dental implant placement. While a wide variety of bone graft and barrier~     membrane products are commercially available, limited evidence exists supporting the use of~     one technique over another. The purpose of this study is to radiographically define the~     dimensional bone changes following horizontal bone augmentation using a synthetic GUIDOR®~     (Sunstar, Inc.) membrane. Secondary outcome measurements will include the assessment of~     inflammation, infection, or other wound healing complications.~      Participants: A total of 60 patients requiring bone augmentation of a single bound edentulous~     site prior to dental implant placement will be selected for this study. This is a multicenter~     study with 30 patients receiving treatment at each study site.~      Procedures (methods): Patients will be randomly allocated to receive horizontal bone~     augmentation with synthetic GUIDOR® membrane + freeze dried bone augmentation (FDBA),~     synthetic GUIDOR® membrane alone, or xenograft BioGide® membrane + FDBA. CBCT imaging will be~     obtained at baseline and 6 months post-operatively to assess dimensional alveolar ridge~     changes. Additionally, post-operative appointments at 1, 2, and 4 weeks post-grafting will be~     completed to assess the presence of inflammation, infection, wound dehiscence, or membrane~     exposure.~   "
90162|NCT02386995|"~     The main objective of the study is to determine whether depth of anesthesia (DOA) monitoring~     such as Bispectral Index (BIS) and entropy are accurate in patients with neuro-psychological~     conditions such as Parkinson's disease by comparing these monitoring with standard clinical~     monitoring like heart rate, blood pressure and respiratory rate.~   "
90163|NCT02386982|"~     This study evaluates the beta cell function, pharmacodynamics, pharmacokinetics, safety and~     tolerability after 4 weeks treatment of 75mgBID or 75mgQD of HMS5552.~   "
90164|NCT02386969|"~     The repetitive transcranial magnetic stimulation (rTMS) is used in pain treatment for several~     years. The aim of the study is to assess, in a rigorous scientific protocol, analgesic effect~     of the neuronavigated rTMS assisted by robotic arm on chronic neuropathic painful subjects.~     The crossover study is randomized, double blinded and controlled (sham rTMS) and it includes~     a large homogeneous population suffering of central neuropathic pain.~   "
90165|NCT02386956|"~     Randomized clinical trial to evaluate the elongation of the hamstrings after making different~     types of stretching. One group receives a stretch of global postural reeducation (RPG),~     another group receives a mobilization of sciatic nerve, and a third group received a placebo~     treatment. The evaluation of these treatments are done previously, immediately after and 20~     min later. The test used to evaluate elongation are the Sit and Reach and active knee~     extension (AKE test).~   "
90166|NCT02386943|"~     The objective of this study is to explore the effects of two DPP-4 inhibitors(Sitagliptin,~     Saxagliptin) on β- and α-cell function, as well as the incretin effect.~   "
90167|NCT02386930|"~     The primary purpose of this study is to develop a behavioral lifestyle intervention and~     evaluate its effectiveness in improving the glycemic control in patients with type 2 diabetes~     in real life setting. This is because ambiguity still exists on the effectiveness of~     behavioral lifestyle interventions in routine clinical practice despite of the efficacy of~     large randomized controlled trials, suggesting the need for more research in this area.~   "
90168|NCT02386917|"~     Drug bioavailability and disposition vary according to body weight and weight loss after~     bariatric surgery. This study evaluates the impact of body weight and weight loss on the~     pharmacokinetics of various probe drugs, and compares these effects in three groups of~     patients receiving either a gall bladder operation, gastric bypass or a very low calorie~     diet.~   "
90169|NCT02386904|"~     The Purpose of the study is to determine the efficacy of Kleen Enema® (Phosphate Enema) for~     bowel preparation in out-patients under going sigmoidoscopy procedure and to evaluate the~     safety behavior of Kleen Enema® in outpatients requiring sigmoidoscopy~   "
90170|NCT02386891|"~     Based on preliminary data and previous studies, the investigators hypothesize that the~     ambient temperature experienced by an individual influences his or her food intake in males~     and females aged 19 to 30. Specifically, exposure to temperatures above the thermoneutral~     zone (TNZ) will decrease consumption in young adults in a sedentary situation. Researchers~     will execute a randomized control trial specifically testing thermal exposure and its effect~     on an individual's food consumption. Participants will receive and wear a t-shirt. They will~     have a thermal image taken of the inner canthus of their eye and middle finger nail bed,~     representing a baseline of core and peripheral temperatures, respectively. They will be~     randomized to either a colder environment (65°F) or a warmer environment (75°F) under the~     artifice of monitoring routine office work with abnormal temperature conditions. Their~     knowledge of the experiment will be limited until the end. They will experience this~     temperature while filling out paperwork and performing basic office tasks. After one hour,~     another thermal image will be taken. Each participant will be presented with a large, Mellow~     Mushroom cheese pizza and directed to eat at their leisure and subsequently finish the office~     tasks over the next hour. The participants will then be debriefed on the parameters of the~     experiment and body measurements will be taken at the end so as to prevent bias of the~     subject by limiting their food intake. The investigators will quantify energy intake by~     weighing remaining food and comparing to known caloric content by weight from bomb~     calorimetry tests. The infrared thermal images will determine whether the temperatures~     experienced were extreme enough to initiate a change in thermoregulation.~   "
90242|NCT02385955|"~     This study aimed to evaluate the efficacy and safety of myeloablative double unit umbilical~     cord blood transplantation (dUCBT) in adult patients with hematologic malignancies. Two~     myeloablative conditioning regimens will be used in this study: (1) total body irradation~     (TBI), cyclophosphamide, and cytarabine, or (2) thiotepa, busulfan, and fludarabine.~   "
90171|NCT02386878|"~     The PHE study is a two-year longitudinal study evaluating two interventions for reducing~     depression and HIV risk behaviors among highly vulnerable adolescents in the Eastern Cape of~     South Africa. Research suggests that children affected by AIDS are at heightened risk of HIV~     infection relative to their peers; however, evidence on how best to address HIV prevention~     and psychological health among this population is lacking. This study examines the efficacy~     of both a psychological and behavioral intervention, alone and in combination, on related~     outcomes among vulnerable youth age 14-17. A mixed methods approach is applied, including a~     community-randomized controlled trial with a factorial design, a cost-effectiveness analysis,~     and a qualitative component. At baseline data collection in January 2012, more than 1000~     adolescents and their caregivers were interviewed; these participants were invited to take~     part in two more survey rounds designed to examine both the immediate and long term effects~     of the interventions. Support for this research was provided by USAID under Grant No.~     GHH-I-00-007-00069-00.~   "
90172|NCT02386865|"~     Although several prognostic models have been developed to predict outcome for patients with~     severe traumatic brain injury (TBI), currently no study describes the impact of respiratory~     failure during Emergency Department treatment on mortality in a population of elderly~     patients. The purpose of the present study was to evaluate factors predicting poor outcome~     with special emphasis on the impact of respiratory failure on mortality in elderly patients~     with isolated severe TBI.~      All elderly patients (age ≥ 65 years) with isolated severe head injury, admitted to this~     Level I trauma center, during a period of 16 years (from January 1992 to December 2008) were~     identified from the trauma registry. Stepwise logistic regression analysis was used to~     identify risk factors for a poor prognosis and outcome.~      The logistic regression found the following variables influencing the mortality: respiratory~     failure (p<0.0005; OR: 9.369), pupillary response (p<0.0212, OR: 3.393) and ISS score~     (p<0.0001, OR:1.179). A significant (p<0.0001) increased risk of death was also found for~     patients with a midline shift >15 mm.~      The present study predicts a strong correlation between respiratory failure, pathological~     pupillary response, a higher ISS and substantial midline shift with poor outcomes in elderly~     patients sustaining an isolated severe TBI.~   "
90173|NCT02386852|"~     There is some evidence to suggest that ginseng and Ginkgo biloba can improve cognitive~     performance, however, very little is known about the mechanisms associated with such~     improvement. Here, we tested whether cardiovascular reactivity to a task is associated with~     cognitive improvement.~   "
90174|NCT02386839|"~     This observational study will compare safety and efficacy treatment outcomes in infants that~     received study drug treatment with infants that received standard neonatal care in Study~     ROPP-2008-01 (NCT01096784).~   "
90175|NCT02386826|"~     The purpose of this study is to determine whether the combination of two agents, INC280 and~     bevacizumab, is safe and effective when administered to patients with Glioblastoma Multiforme~     (GBM) who have progressed after receiving prior therapy or who have unresectable GBM.~   "
90176|NCT02386813|"~     This study is to explore risk factors for poor progression-free survival (PFS) and overall~     survival (OS) in ENKTL, and establish a prognostic model for ENKTL patients treated with~     non-anthracycline based treatment.~   "
90177|NCT02386800|"~     This roll-over protocol allows patients who are still receiving clinical benefit to continue~     to be treated from multiple protocols in one program spanning multiple indications during the~     completion of the parent study/(ies). The population for the roll-over study should be~     consistent with the population defined in the program parent study/(ies). The primary~     eligibility criteria for a patient to enter the roll-over protocol is the participation and~     completion of a Novartis OGD&GMA/Incyte study with ruxolitinib. Efficacy parameters would not~     be measured; however safety data will be collected.~      Patients who have completed a prior study with ruxolitinib and who are assessed by the~     Investigator to continue to benefit from ongoing treatment with the investigational~     ruxolitinib will be eligible.~   "
90178|NCT02386787|"~     Aspiration of gastric content is a rare but serious complication of anesthesia. In this~     context, preoperative fasting for elective surgery is well defined. In an emergency~     situation, international guidelines recommend rapid sequence of anesthesia to reduce the risk~     of aspiration. In semi emergency situation, there is no consensus about the anesthetic~     procedure even if a preoperative fasting has been observed due to uncertainty of gastric~     emptying related to stress or painful condition. The choice of anesthesia induction technique~     depends mainly on the anesthetist. Ultrasonography is a non invasive bedside tool that can~     provide reliable quantitative information about the volume of gastric content.~   "
90179|NCT02386774|"~     In vivo confocal microscopy (IVCM) used in tertiary care ophthalmology centers is performed~     with two reflectance microscopes attached on a mounting with limited movement along the XYZ~     axes. Consequently, ocular diseases in the central area have been described (mostly cornea~     and adjacent conjunctiva). Two dermatology IVCM (an handheld small IVCM and a~     multifluorescent one) present significant innovations that the investigators want to assess~     in ophthalmology for the diagnosis of conjunctiva, cornea, eyelid and lachrymal tract~     diseases. The handheld IVCM have unlimited degrees of freedom and a small diameter objective.~     It could dramatically increase the area accessible to IVCM (whole conjunctiva, eyelids,~     proximal lachrymal tract) (part 1 of the present study). The fluorescent IVCM allows the use~     of a wide range of fluorescent markers liable to increase the specificity of the diagnosis by~     revealing staining patterns corresponding to a specific disease and not to others (part 2 of~     the study)~   "
90180|NCT02386761|"~     A phase I randomised, double-blind, placebo-controlled study of single and repeated ascending~     doses in healthy volunteers to investigate the safety, tolerability and pharmacokinetics of~     inhaled chf 6001.~   "
90212|NCT02386345|"~     This is a registry to assess the safety and effectiveness of FIRM guided procedures for the~     treatment of symptomatic any type of atrial fibrillation.~      FIRM (Focal Impulse and Rotor Modulation) guided ablation is defined as ablating rotors~     identified by the FIRMap® basket catheter for visualising of rotors with the RhythmView®~     mapping system. In addition to the FIRM guided ablation any other ablation method could be~     applied.The acute success of FIRM ablations is defined as elimination of rotors defined by~     absence of rotors.~      Data items will be collected, if available, consistent and applicable with routine and~     standard clinical care at each participating site.~   "
90181|NCT02386748|"~     The study purpose is to evaluate the efficacy and safety of postoperative gum chewing on the~     recovery of intestinal movement after cesarean section.~      All women undergoing elective cesarean section in King Faisal military hospital will be~     candidate for this trial after full explanation of the trial and informed consent to be taken~     from the women. Exclusion criteria will include emergency cesarean section, multifetal~     pregnancy, polyhydramnios, medical disorders with pregnancy, abnormal placentation (previa~     and/or accreta), past history of bowel injury or operation, any complications that will~     increase operative duration such as uterine artery injury or uterine extension.~      450 consented women for being enrolled in this clinical trial and candidates for elective~     cesarean section will be divided into 3 groups:~        -  Group A, 150 women will receive sugarless gum after their operating room discharge by 2~          hours for at least half an hour at two hours interval.~        -  Group B, 150 women will receive the traditional management of starting oral fluids after~          operating room discharge by 6 hours and hearing intestinal sounds on second day before~          initiating full regular diet.~        -  Group C, 150 women as control group, they will not receive neither gum nor oral fluids.~          They will be in intravenous fluid.~      All demographic data of these women, indication of operation, operation time, type of~     anesthesia and pathway during hospital stay will be recovered and compared between 3 groups.~   "
90182|NCT02386735|"~     Background~      Chronic obstructive pulmonary disease (COPD) is a major public health issue with no curative~     treatment. In Switzerland estimated 5-7% of the total population are suffering from this~     chronic disease. According to current guidelines corticosteroids are part of treatment of~     acute exacerbations in COPD patients. Several studies suggest that corticosteroids accelerate~     the recovery of forced expiratory volume in 1 second (FEV1), decrease duration of~     hospitalization, reduce treatment failure rate and improve clinical outcome. The additional~     therapeutic benefit on FEV1-recovery tough seems only to last for three to five days. The~     investigators recently published a hospital-based study showing that in patients presenting~     to emergency departments with acute exacerbation of COPD, a short five day treatment with~     systemic steroids was not inferior to a conventional 14 day treatment with regard to~     re-exacerbation. Cumulative corticosteroid dose could be reduced in this trial. To the~     investigators knowledge no data is available about the minimal necessary corticosteroid dose~     in an outpatient treatment setting so far.~      Aim~      The primary aim of this study is to investigate in an outpatient setting, whether a three day~     treatment with orally administered systemic corticosteroids is non-inferior to a five day~     treatment in acute exacerbation of COPD and if total glucocorticoid exposure can be reduced~     by shorter therapy.~      Hypothesis~      The investigators postulate, that in an outpatient setting, where generally less severe~     exacerbations are being treated, a three day treatment duration of systemic corticosteroids~     should be non-inferior to a five day treatment duration with regard to treatment benefits but~     decrease cumulative corticosteroid exposure.~      Design and Setting~      This study is going to be performed as a prospective, randomized, double-blind,~     placebo-controlled, non-inferiority trial in an outpatient setting. Randomization will be~     performed as block randomization with a 1:1 allocation. The investigators are going to~     recruit GPs in northwestern and central Switzerland.~      Methods~      The investigators are going to include patients presenting to GP's with acute exacerbation of~     COPD. When matching the investigators eligibility criteria and written informed consent is~     given, patients included in the study are receiving systemic corticosteroid treatment~     (equivalent of 40mg prednisone daily) for either five days (conventional arm) or three days~     (interventional arm) followed by two days of placebo for the interventional group.~     Pre-randomized, identically looking, numbered blisters are given to all patients included in~     the study. Antibiotic treatment (Amoxicillin/Clavulanic acid, 625mg 3/d, for ten days) is~     given to all patients with a CRP ≥50mg/l, COPD and known diagnosis of bronchiectasis, as well~     as patients presenting with all three of the following symptoms: change of baseline dyspnea,~     change of sputum quantity and sputum purulence. Further initial treatment and steroid~     treatment after inclusion is determined and documented by the GP. Patients will undergo~     follow-up visits at day three and seven by their GP as well as follow-up phone calls executed~     by the study center at day 30, 90 and 180.~   "
90183|NCT02386722|"~     Asthma and chronic obstructive pulmonary disease (COPD) are common lung. Despite the~     important progresses achieved in treatments, the majority of affected patients suffer from~     severe symptoms and tend to be frequently hospitalised due to exacerbation. Reasons for~     uncontrolled asthma and COPD are manifold, but often a poor inhalation technique and a poor~     following of the prescribed treatment plan is observed, which is called non-adherence.~      The primary aim of this study will therefore be to measure medication adherence in patients~     with chronic obstructive lung diseases, and to investigate the impact of an audio reminder on~     disease outcomes and quality of life.~      The investigators hypotheses will be that an adherence reminder, improve medication adherence~     and that a good medication adherence elongate the time to next exacerbation in patients with~     chronic obstructive lung diseases.~      A prospective single-blind randomized controlled study is planned, where the investigators~     are going to analyse the adherence over a period of six months of in- and outpatients, who~     have experienced at least one exacerbation during the last year. The adherence of~     intervention- and control group will be measured by specific electronic data capture devices~     which can save each actuation with date and time. Patients assigned to the intervention group~     will be reminded for the inhalation by an audio reminder and will receive support calls if~     medication will not be taken as prescribed or if rescue medication will be used too often. In~     contrast, the control group, will not be reminded and will not receive any calls, if do not~     comply with the prescribed medication schedule or if they use their rescue medication too~     frequently.~      During study period, participants will be assessed every two months. Each assessment will~     include spirometry, measurement of diffusion capacity, exhaled nitric oxide and carbon~     monoxide. Moreover participants will demonstrate their inhalation techniques by using placebo~     devices and fill out questionnaires regarding quality of life.~      Statistical significance will be acquired if a p value of less than 0.05 is attained. Time to~     next exacerbation will be compared using the Kaplan-Meier method and Cox proportional hazard~     model. Results will be reported as HR (hazard ratio) with corresponding 95% confidence~     interval (CI) and p-value.~      Time to next exacerbation is subject to the investigators power calculation. A previous~     study has shown that 30% of COPD patients are readmitted again within six month because of an~     exacerbation. The investigators expect that 12% of patients in the intervention group will~     have an exacerbation. This corresponds to a hazard ratio of 0.36. Assuming a sample size of~     70 subjects for each study group, there is a power of 80% to detect a HR of 0.36 based on a~     one-tailed test. Additional 14 subjects (7 for each study group) have been added to account~     for drop outs. Therefore, 154 subjects will be investigated in this study.~   "
90184|NCT02386709|"~     Neoadjuvant chemotherapy is frequently proposed to patients with mammary gland cancer. The~     aim is to reduce tumor volume before surgical therapy. Obtaining a pathologic Complete~     Response (pCR) is regarded as a good prognostic factor with less risk of recurrence. The rate~     of pCR is about 20%, although there are important variations according to tumor subtype and~     the type of treatment. The objective of the new therapeutic strategies is to increase this~     response rate.~      The purpose of this study is to investigate the possibility of early evaluation of~     neoadjuvant chemotherapy response after one cycle of neoadjuvant chemotherapy by positron~     emission tomography (PET) with (18) F-fluorodeoxyglucose (FDG) in patients.~   "
90185|NCT02386696|"~     Recently, ultrasound artifacts mimicking lung sliding have been described in absence of the~     visceral pleura, in a group of patients who underwent pneumonectomy. In these patients, lung~     sliding was clearly absent during mechanical ventilation in the operated hemithorax. During~     spontaneous breathing, although of lower intensity compared to the unoperated hemithorax,~     some artifacts mimicking lung sliding and seashore sign were found during each deep~     spontaneous breath. These findings have led to the hypothesis that these artifacts may be due~     to the contraction of the intercostal muscles.~      The objective of the present study is to reproduce such artifacts during contraction of the~     inspiratory and expiratory muscles with closed glottis (Valsalva and Muller maneuvers): in~     this condition each subject is not ventilating and the two pleural layers are not sliding one~     over each other.~   "
90186|NCT02386683|"~     The purpose of this study is to explore the effectiveness of lung-protective ventilation~     during general anesthesia for neurosurgical procedures on postoperative pulmonary outcome,~     compared with traditional ventilation.~   "
90187|NCT02386670|"~     This 5-year randomized controlled trial will compare the efficacy of non-invasive brain~     stimulation (trans-cranial Direct Current Stimulation - tDCS) combined with cognitive~     remediation (CR) versus sham (placebo) tDCS combined with sham (placebo) CR in slowing~     down cognitive decline and preventing Alzheimer's Dementia in older persons with mild~     cognitive impairment or major depressive disorder with or without mild cognitive impairment.~   "
90188|NCT02386657|"~     Sickle Cell Disease is a serious disease that is life-threatening for patients being~     homozygous for the SS form or heterozygous for the SC or bthal forms. The CHU Brugmann~     hospital currently regularly treats about 70 homozygous adult patients and this number is in~     constant augmentation. The age average of the patients is below 30. The hospital developed a~     close collaboration with the Queen Fabiola Kids University Hospital to optimize the~     transition of young sickle cell patients from the pediatric to the adult network.~      The emergency care of sickle cell patients remains a source of worry. Even with a correct~     treatment (Hydroxy-urea or exsanguineous transfusions), patients suffer from frequent sickle~     cell disease crisis when stress or infection cause hemolysis. The pain level is intolerable~     and causes emergency hospital admission (2 to 3 crisis per patient per year on average). The~     crisis are more frequent with poor compliance to the treatments.~      There are several obstacles to the rapid and optimal management of these patients:~        -  fear of causing addiction to heavy pain releaf products (high dosis of morphine)~        -  lack of biological parameters for the determination of the crisis severity.~      The prognostic value of the lactate dehydrogenase (LDH) level in a vaso-occlusive crisis was~     recently stressed while activation of the coagulation, translated by the elevation of various~     parameters including the rate of DD dimers, seemed associated with clinical complications.~     The deleterious role of increased oxidative stress has also been recently demonstrated in~     patients with sickle cell disease, opening new therapeutic avenues.~      This study aims to prospectively evaluate the management of sickle cell patients being~     admitted in the emergency department for a vaso-occlusive crisis. The level of satisfaction~     of the patients will be measured.~      The investigators will also evaluate the predictive value of several routine biological~     parameters regarding the severity of the crisis, including the values of nitrous albumin~     (PNA) as marker of oxydative stress. This last dosage will be made in collaboration with the~     team of Dr Wayenberg and Pr Bottari in Grenoble.~   "
90189|NCT02386644|"~     This study's aim is to evaluate diagnostic accuracy of transperineal ultrasound assessment~     compared with speculum examination, nitrazine and placental micro globulin-1 tests.~   "
90190|NCT02386631|"~     Hallux valgus can be defined as a progressive subluxation of the first metatarsophalangeal~     joint and lateral deviation of the hallux. This common foot condition is associated with~     altered gait patterns. Specifically reduced forward propulsion, leading to gait instability.~     Research has shown that foot problems and pain play a major role towards the contribution of~     falls in the adult population. There are currently two main interventions for the treatment~     of hallux valgus: surgery and orthotic prescription. There has not been a lot of research~     performed evaluating the effects of custom orthotic prescription on hallux valgus.~      Therefore, this study will investigate adults with moderate hallux valgus and the effects of~     orthotic intervention on the efficacy of forward propulsion during walking. It is~     hypothesized that implementation of an orthotic will lead to decreased foot pain, an increase~     in step length, an increase in the forward moment about the ankle and hallux, and a more~     medial center of pressure tracking through the great toe instead of the lesser metatarsals.~      This study will consist of 10 adults. The participant will go through three rounds of testing~     in the lab. The first session will consist of initial baseline testing in which each~     participant will be evaluated for severity of Hallux Valgus and range of motion of the first~     metatarsophalangeal joint. A foot casting will then be performed by a pedorthist and the~     participant will be set up with markers, so as to record motion while they perform 15 walking~     trials across a 10m runway with a force plate embedded in the middle whilst wearing standard~     footwear (no orthotic). The second lab session will consist of the standard footwear (no~     orthotic) walking as well as the addition of standard footwear with custom orthotic walking.~     The third session, after having worn the orthotic for two weeks, will repeat both conditions~     measured in the second lab session. Data about the center of pressure trajectories, step~     length, foot pain, and the moments about the ankle and first metatarsophalangeal joints will~     be collected and calculated.~   "
90191|NCT02386618|"~     Endoscopic mucosal resection (EMR) is considered to be a gold standard of therapy of~     colorectal lateral spreading tumors (LST) without significant risk for lymphatic spread.~     According to the investigators previous study, local residual neoplasia (LRN) after~     conventional endoscopic mucosal resection (EMR)occurs in up to 21% of cases. Endoscopic~     therapy of LRN was not sufficient in 53 % and has not been standardized yet.~   "
90192|NCT02386605|"~     Negative symptoms significantly interfere with daily functioning among individuals with~     schizophrenia. They are strongly related to functional impairments [1] and contribute to the~     poor community outcomes of Veterans with schizophrenia. Motivational negative symptoms~     interfere with obtaining and maintaining employment [2], forming social relationships[3] and~     living independently [4]. Developing treatments to effectively reduce negative symptoms is~     important to achieve improvements in daily functioning. Recent empirical studies report that~     psychosocial interventions for negative symptoms can have a moderate to large effect size on~     community functioning and negative symptom severity. However, the treatments that have been~     utilized so far are either cognitive-behavioral therapy interventions that require over a~     year of weekly individual sessions and thus are very resource- and time-intensive, or they~     are skills-training groups that do not address any of the cognitive and motivational aspects~     of negative symptoms. Although group treatments are increasingly hailed as the gold standard~     for schizophrenia, there is currently no group intervention explicitly for motivational~     negative symptoms and functional deficits. Furthermore, treatment development and clinical~     trials are increasingly reliant on neurophysiological measures of clinical severity and~     treatment response and so far there are not identified negative symptom biomarkers.~      The current CDA proposal will test a group-based treatment based on established motivational~     enhancement (MI) techniques, augmented with cognitive-behavioral approaches, compared to an~     active control group treatment, for improving motivational negative symptoms in Veterans with~     schizophrenia. I will assess the efficacy of MI with measures from two outcome domains: 1)~     negative symptoms (clinical ratings) and 2) functional outcomes (real-world improvements in~     social, instrumental, and independent living). I will assess the relationship between these~     outcomes and neurophysiological biomarkers (pupillometry and electroencephalography (EEG)).~     Participants will be randomly assigned to the MI treatment or a control treatment for weekly~     1-hour sessions for 12 weeks. The assessment battery will be administered at baseline, at~     completion of treatment, and at 6-month follow-up. The investigators will enroll 60 Veterans~     with schizophrenia that are low functioning and have high negative symptoms across the 4~     years of the study.~      This proposal is designed to examine group-based MI for reducing negative symptoms and~     improving functioning in key domains (i.e., interpersonal, instrumental, and independent~     living skills). Moreover, it will thoroughly investigate biomarkers of negative symptoms with~     pupillometry and EEG. The development and evaluation of this recovery- oriented group MI~     treatment for Veterans with disabling negative symptoms will yield results that can inform~     larger treatment trials and neurophysiological measurement of negative symptoms in Veterans~     with schizophrenia.~   "
90193|NCT02386592|"~     The purpose of this study is to estimate the burden of disease, identify risk factors~     associated with nosocomial bacteremia among neonates and assess the efficacy of low-cost~     measures targeted to known and suspected nosocomial BSI (bloodstream) risk factors, the~     investigators propose to study the impact of a novel package of infection control~     interventions on nosocomial bacteremia and mortality among neonates at a tertiary care center~     in sub-Saharan Africa.~   "
90194|NCT02386579|"~     The study is designed to investigate biomarkers related to bone turnover in diabetics with~     charcot foot. This is done by measuring local blood samples in the feet, and systemically in~     a vene and an artery. Measurements are done before and after cooling the feet in icewater to~     lower the bloodflow.~      Patients will be compared with healthy diabetic controls.~   "
90195|NCT02386566|"~     The primary objective of the study is to determine the association between prospectively~     measured disability (Expanded Disability Status Scale [EDSS]) with quality of life (Multiple~     Sclerosis International Quality of Life Questionnaire [MusiQoL]) at 3-month intervals up to 1~     year in a real life setting of multiple sclerosis (MS) patients treated with natalizumab. The~     secondary objectives of this study are as follows: To evaluate the cumulative probability of~     sustained EDSS changes at 1 year following natalizumab treatment initiation; To evaluate the~     association between disability (EDSS), fatigue (Fatigue Scale of Motor and Cognitive Function~     [FSMC]), sexual dysfunction (Multiple Sclerosis Intimacy and Sexuality Questionnaire-19~     [MSISQ-19]), depression (Beck Depression Inventory-Fast Screen [BDI-FS]) and neurocognitive~     function (Symbol Digit Modalities Test [SDMT]) with EuroQol-5D Questionnaire (EQ-5D) at 3 to~     6-months intervals up to 1 year after initiation of natalizumab treatment; To assess the~     relationship between clinical disease-free status (no EDSS increase of 1.0 and no relapse)~     and MusiQoL at 1 year following natalizumab treatment initiation; To record the number of~     clinical relapses and relapses requiring steroid treatment at 3-months intervals up to 1 year~     after initiation of natalizumab treatment; To describe changes in work impairment (Work~     Productivity and Activity Impairment in MS [WPAI-MS]) at 3-months intervals up to 1 year~     after initiation of natalizumab treatment; To describe any change in the percentage of~     disability pension and occupation after 1 year of natalizumab treatment; To record the~     incidence and number of Serious Adverse Events (SAE) and Suspected Unexpected Serious Adverse~     Reactions (SUSAR) throughout the study~   "
90196|NCT02386553|"~     The primary objective of the study is to examine the efficacy of multiple doses of Nusinersen~     administered intrathecally in preventing or delaying the need for respiratory intervention or~     death in infants with genetically diagnosed and presymptomatic spinal muscular atrophy (SMA).~     Secondary objectives of this study are to examine the effects of Nusinersen in infants with~     genetically diagnosed and presymptomatic SMA.~   "
90197|NCT02386540|"~     The purpose of this study is to determine whether health coaching initiated in the emergency~     department (ED) reduces subsequent ED visits, increases primary care visits, and positively~     impacts health outcomes in patients with diabetes and/or hypertension.~   "
90213|NCT02386332|"~     This is an open-label, prospective, observational, multicenter, randomized study to compare~     the efficacy between unrelated umbilical cord blood transplantation (UCBT) and~     HLA-haploidentical related hematopoietic stem cell transplantation ,after myeloablative~     conditioning for adult patients with hematologic malignancies.~   "
90198|NCT02386527|"~     Rheumatoid arthritis (RA) is the most common form of inflammatory arthritis. In the US, it is~     estimated that as many as 3 million adults may suffer from the disease. Fortunately in the~     last few years, a shift in strategy toward the earlier institution of disease modifying drugs~     and the availability of new classes of medications have greatly improved the outcomes that~     can be expected by most patients.~      The goal of treatment now aims toward achieving the lowest possible level of arthritis~     disease activity and even remission, if possible as early on as possible. Research has shown~     that this translates into minimized joint damage and enhanced physical function and quality~     of life for the RA patient. This also requires that a diagnosis of RA be made as early on as~     possible, and herein lies the challenge, i.e. identifying the RA patient early on in the~     course of their disease.~   "
90199|NCT02386514|"~     To evaluate if a rapid urine Nucleic Acid Amplification Testing (NAAT) is non-inferior to the~     traditional swab NAAT for gonorrhea and chlamydia when performed in the Emergency Department.~   "
90200|NCT02386501|"~     This is a Phase 1b, multicenter, open-label, dose-escalation study designed to estimate the~     maximum tolerated dose (MTD) and determine the recommended Phase 2 dose (RP2D) of ADXS31-164.~     Once the RP2D has been selected, up to 4 expansion cohorts will be evaluated.~   "
90201|NCT02386488|"~     The purpose of this study is to determine the pharmacokinetic (PK) parameters of vortioxetine~     after single and multiple oral dosing to healthy Chinese men and women.~   "
90202|NCT02386475|"~     Cortical plasticity plays a pivotal role in functional recovery after a stroke.~     Neurotransmitter release, facilitates the creation of new synapses and promotes brain~     plasticity. In a pilot study, will evaluate the potential benefit of drugs that increase the~     release of neurotransmitters in patients with first stroke.~   "
90203|NCT02386462|"~     Dexmedetomidine can be used as a co-induction agent to facilitate laryngeal mask airway (LMA)~     insertion with minimal effect on respiratory function. The purpose of the study was to~     determine the median effective dose (ED50) of dexmedetomidine to facilitate LMA insertion~     during anaesthesia induction with propofol 2.0 mg/kg.~   "
90204|NCT02386449|"~     This is a randomized, controlled, parallel group, assessor-blinded study to compare two colon~     cleansing preparations for colonoscopy. Subjects meeting all inclusion and exclusion criteria~     will be randomized and assigned to one of two study groups: Group I (PicoPrep) or Group II~     (Mannitol). In Group I, subjects will take one sachet of PicoPrep on the day before~     colonoscopy, and another sachet on the day of colonoscopy. In Group II, subjects will take~     Bisacodyl on the day before colonoscopy, and Mannitol on the day of colonoscopy.~   "
90205|NCT02386436|"~     GSK2330811 is a humanised monoclonal antibody, that blocks Oncostatin M (OSM), which is being~     developed for the treatment of inflammatory and fibrotic diseases. This first time in human~     study will evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and~     immunogenicity profile of single ascending subcutaneous (s.c.) doses of GSK2330811, in~     healthy subjects.~      This study will be a randomised, double-blind (sponsor open), placebo-controlled, single~     centre, single dose escalation study of s.c. administrations of GSK2330811 in healthy~     subjects. Approximately 40 subjects will be enrolled in the study, across 5 cohorts. Each~     cohort is planned to consist of 8 subjects, randomised such that 6 subjects will receive~     GSK2330811 and 2 subjects will receive placebo.~      The starting dose for the study will be 0.1 milligram (mg)/kilogram (kg) s.c. single dose and~     the highest dose will be 6 mg/kg s.c. single dose. Subjects will be admitted to the clinical~     unit on the day prior to dosing (Day -1). On Day 1, each subject will receive a s.c. dose of~     GSK2330811 or placebo. Subjects will then remain as an in-patient until discharged on Day 8,~     after assessments have been performed. The duration of the study, including screening, is~     approximately 19 weeks for Cohorts 1 to 4 and 23 weeks for Cohort 5.~   "
90206|NCT02386423|"~     The purpose of this study is to determine the safety and efficacy of RESTIFFIC™, a foot wrap~     that produces adjustable targeted pressure on specific muscles in the feet, to reduce the~     symptoms of moderate to severe primary Restless Legs Syndrome.~   "
90207|NCT02386410|"~     Anxiety is the most frequent psychiatric problem in children. Untreated anxiety often has a~     chronic course, or may be a recurring condition. Anxiety in children predicts a variety of~     psychiatric disorders later in life, and involves problems regarding school performance and~     social relations. The literature provides a number of factors, which are suggested to~     increase the risk of developing an anxiety disorder. In particular, it has been shown that~     children of parents with anxiety disorders are at much greater risk of developing an anxiety~     disorder. Several studies have found a correlation between anxiety in the child, and parent~     behavior characterized by criticism, control and overprotectiveness. The present study aim to~     preliminary evaluate whether a eight week parent training intervention can reduce the~     incidence of anxiety disorders in children and to evaluate the feasibility of the parent~     training. Three central factors has been the basis in developing the parent training, all of~     which are considered to be involved in the development and maintenance of anxiety disorders~     in children (1) criticism and rejection, (2) control and overprotectiveness, and (3) parental~     modeling and reinforcement of anxiety. The goal of the parent training is therefore (1) to~     increase warmth and acceptance, (2) to increase autonomy for the child, and (3) modeling and~     reinforcement of brave behavior. The investigators intend to include 60 anxious parents in~     the study, who will be randomly allocated to either group parent training, Internet delivered~     parent training, or wait-list condition. The inclusion criteria are as follows: The parent~     states that he/she experiences anxiety or worry, the parents' child is 6-12 years old, and do~     not fulfill criteria for an anxiety disorder or major depressive disorder, the parent~     possesses everyday access to the Internet, and there is no presence of very aggravated family~     situations, such as parent substance abuse or severe depression, or domestic violence.~   "
90208|NCT02386397|"~     This study is to determine the Regorafenib Dose (RD) for the phase II trial of Regorafenib~     administered in combination with mGEMOX in patients with advanced biliary tract cancer.~   "
90209|NCT02386384|"~     Question: Can implantation failure (IF) be predicted prior to in vitro fertilization (IVF)? A~     pilot, non-interventional, clinical study Prospective, controlled, cohort study~   "
90210|NCT02386371|"~     The investigators propose a prospective, multicenter, single arm Phase II design to evaluate~     the feasibility of repeated breast-conserving surgery combined with re- irradiation using~     IORT after local recurrence of breast carcinoma.~   "
90211|NCT02386358|"~     The purpose of this study is:~        1. -to determine whether benznidazole (BZN) will be able to modify the natural evolution of~          chronic Chagas disease in adult patients by means of a randomized, double-blind clinical~          trial (RCT).~           Also:~        2. -to validate therapeutic efficacy with new methods, such as recombinant antigen F29 of~          Trypanosoma cruzi visualized by conventional ELISA, in the context of the RCT compared~          with conventional serology (CS)~        3. -to develop the real-time polymerase chain-reaction (RT-PCR) to quantify the parasite~          load as an early therapeutic effect.~        4. to determine the potential of such serological and parasitological methods as predictors~          of therapeutic effect or failure.~   "
90215|NCT02386306|"~     This is a Phase 1b, multi-center, randomized, double-blind, placebo-controlled study designed~     to evaluate the safety, tolerability, and pharmacokinetics of GC021109 in subjects with mild~     to moderate Alzheimer's Disease (as determined by 2011 National Institute on Aging-~     Alzheimer's Association [NIA-AA] criteria and Mini Mental State Examination [MMSE]). The~     Investigator, study site staff, (with exception of a designated pharmacist/pharmacy~     technician) and all study subjects will be blinded to randomized study medication assignment~     until database lock. Treatment assignments may be unblinded for select pre-authorized~     individuals involved in the safety and PK data reviews in order to accurately determine how~     to proceed with dose escalation.~   "
90216|NCT02386293|"~     The purpose of this study is to test the hypothesis that hypertension increases the~     anti-natriuretic effects of an angiotensin receptor antagonist during mental stress in~     overweight/obese African-American's who retain sodium during mental stress.~   "
90217|NCT02386280|"~     To investigate whether brief motivational intervention is associated with the change of~     parenting style in parents of teenagers seeking to prevent drug use among their children.~   "
90218|NCT02386267|"~     Diamond-Blackfan anemia (DBA) is a rare congenital syndrome associated with physical~     anomalies, short stature, red cell aplasia, and an increased risk of malignancy.~      Mutations affecting genes encoding ribosomal proteins cause DBA. Genetic studies have~     identified heterozygous mutations in at least one of eight ribosomal protein genes in up to~     50% of cases.~      25% of patients carry a mutation in the ribosomal protein (RP)S19 gene, whereas mutations in~     RPS24, RPS17, RPL35A, RPL11, and RPL5 are rare.~      p53 activation has been identified as a key component in the pathophysiology of DBA after~     cellular and molecular studies. Other potential mechanisms that warrant further investigation~     include impaired translation as the result of ribosomal insufficiency, which may be~     ameliorated by Leucine supplementation.~      Despite significant improvements in understanding of the pathophysiology of Diamond Blackfan~     anemia (DBA), there have been few advances in therapy. The cornerstones of treatment remain~     corticosteroids,chronic red blood cell transfusions, and hematopoietic stem cell~     transplantation, each of which is fraught with complications. Other treatments have been~     shown to be effective in only a few patients or in individual case reports : IL-3,~     cyclosporine (alone or in combination with steroids), metaclopramide. Gene therapy is still a~     part of research programs.~      There are some indications that the Amino Acid (AA) L-leucine, a translation enhancer, may~     have some efficacy in DBA and 5q-syndrome, which has the same altered ribosome functions as~     the DBA. L-leucine is an essential AA that is unique among the branched-chain AA acting as a~     nutrient regulator of protein synthesis in skeletal muscle and adipose tissue.~      Several preclinical studies with DBA lymphocytes exposed to various L-leucine doses, have~     demonstrated that protein synthesis can be increased by using high doses L-leucine.~      Recent clinical data on L-leucine therapeutic use have demonstrated increase the hemoglobin~     level and transfusion independence in patients with DBA and 5q-syndrom.~      These data support the rationale for clinical trial on L-leucine use as a therapeutic agent~     for DBA patients.~   "
90219|NCT02386254|"~     To evaluate whether a premorbid functioning scoring system such as the ECOG system can be~     adapted to predict ICU morbidity and mortality.~   "
90220|NCT02386241|"~     This study will compare genomic alterations between the parents and the patients with~     high-grade glioma.~   "
90221|NCT02386228|"~     A collection of biological samples (cerebrospinal fluid [CSF] and blood) from patients under~     6 years of age who are diagnosed with intraventricular hemorrhage or spina bifida.~   "
90222|NCT02386215|"~     This randomized controlled trial will explore whether the provision of oral HIV self-test~     kits to women can increase HIV testing among their male partners. The study will recruit~     adult women from antenatal care and post-partum clinics in Kisumu. Each participant will be~     randomized to either receive two HIV self-tests or to receive counseling referring their~     partner to HIV testing (standard of care). Over a 3 month period, we will obtain information~     from study participants on how many sexual partners they offered the tests to, the~     receptivity of their sexual partners to using self-tests, and the incidence of any adverse~     events. We will compare partner testing rates in intervention and control groups.~   "
90223|NCT02386202|"~     To determine the incidence and predictors of augmented renal clearance (ARC) in patients with~     hemorrhagic stroke.~   "
90224|NCT02386189|"~     The purpose of this study is 1) to learn how VA patients can help share their health~     information between their VA providers and providers outside the VA and 2) if sharing this~     information is useful to providers and improves care received.~   "
90225|NCT02386176|"~     The investigators are interested in assessing the value of and comparing the use of automated~     breast ultrasound (ABUS) (either as a primary screening approach or as a supplementary~     procedure) with digital breast tomosynthesis (DBT). The purpose of this project is to perform~     a preliminary prospective study on women who are most likely to benefit from the use of ABUS~     and/or DBT (or a combination of both) in the screening environment.~   "
90226|NCT02386163|"~     According to many researches, mesenchymal stem cells (MSC) isolated from synovial membrane~     and infrapatellar fat pad have higher ex vivo proliferation capacity, multipotency and~     ability to undergo chondrogenesis.~      Based on this concept, the investigators plan to get two removed tissues (synovial membrane~     and infrapatellar fat pad) from patients who have an operation of TKR (Total Knee~     Replacement). The investigators are going to isolate and expand MSC from these two tissues~     respectively, and then compare their characterization and potential for clinical application.~     In the other hand, the investigators plan to build techniques and procedures which comply~     with Good Tissue Practices (GTP).~   "
90227|NCT02386150|"~     This study seeks to determine the safety and immunogenicity of a series of 3 primary~     vaccinations and a booster vaccination of Recombinant ricin toxin A-chain 1-33/44-198 (rRTA~     1-33/44-198) vaccine (RVEc) at 10 or 20 μg intradermally (ID). This study is evaluating if~     RVEc will display an acceptable safety profile as determined by adverse event (AE) data and~     if RVEc will elicit anti-ricin antibody titers and ricin toxin-neutralizing antibodies in~     vaccine recipients.~   "
90228|NCT02386137|"~     Magnetic resonance (MR)-guided high-intensity focused ultrasound (HIFU) ablation is~     increasingly being used worldwide to treat symptomatic uterine fibroids because of its~     excellent therapeutic efficacy in controlling symptoms and its excellent safety record.~     Despite the benefits, it should be recognized that MR HIFU ablation does not always yield~     good therapeutic outcomes. High signal intensity on T2-weighted MR images and a high volume~     transfer constant (or Ktrans) on dynamic contrast material-enhanced MR images are the most~     well-known risk factors for poor ablation outcomes as measured with the non-perfused volume~     (NPV) ratio (ie, NPV divided by fibroid volume).~      The aim of this study is to assess the influence of fibroid perfusion (evaluated by MRI and~     contrast enhanced ultrasound), apparent diffusion coefficient (evaluated by MR-diffusion~     imaging) and fibroid stiffness (evaluated by ARFI) on ablation efficiency during uterine~     fibroid treatment by MR-HIFU.~   "
90229|NCT02386124|"~     In Italy, life expectancy at birth has reached 80 years in men and 85 in women; in about 50~     years, life expectancy at the age of 80 has increased by an extraordinary 61% and 55%,~     respectively, due to more effective therapies and lower mortality of many diseases. Yet,~     chronic diseases are nowadays more important, and often coexist as comorbidity or~     multimorbidity, depending on whether an index condition has been considered. These conditions~     increase the risk of death and reduce functional autonomy in the elderly and, therefore,~     should be carefully considered within comprehensive geriatric assessment. The epidemiology of~     cardiovascular disease, as demonstrated among others by the Oxford Vascular Study, shows a~     clear trend in age-dependent, as the number of events and their incidence increases with age,~     and about half are concentrates over 75 years.~      In addition, some observational studies in elderly patients have suggested an association~     between frailty and cardiovascular disease: fragility and cardiovascular disease share a~     common biological pathway, and cardiovascular diseases may accelerate the onset of frailty.~     The frailty syndrome was identified in 25% to 50% of patients with cardiovascular disease,~     according to the rating scale used and the population studied. Frail patients with~     cardiovascular disease, in particular those undergoing invasive procedures or suffering from~     coronary artery disease and aortic valve disease, have a much higher adverse events and~     complications, suggesting the need for a more accurate functional stratification and a more~     careful evaluation of the risk/benefit ratio of some invasive procedures.~      Among the numerous tests proposed in the literature for the functional evaluation and~     objective measures of physical capability in elderly patient, the Short Physical Performance~     Battery (SPPB) and the evaluation of hand grip strength (grip strength) are those~     characterized by an improved prognostic ability and an easy administration.~      The present study is performed to assess if SPPB and handgrip are helpful to better stratify~     the prognosis (all-causes death and hospital admission for all causes) in elderly patients~     admitted to hospital for cardiac causes.~   "
90230|NCT02386111|"~     This is a study to determine the clinical benefit (how well the drug works), safety, and~     tolerability of combining varlilumab and sunitinib. The study will enroll patients with~     metastatic clear cell renal cell carcinoma.~   "
90231|NCT02386098|"~     The purpose of this study is to evaluate whether the combination of BMS-955176 with~     atazanavir (ATV) [with or without ritonavir (RTV)] and dolutegravir (DTG) is efficacious,~     safe, and well-tolerated in HIV-1 infected treatment experienced adults.~   "
90232|NCT02386085|"~     Currently, there is a significant deficiency in evidence regarding the safety of osteopathic~     manipulative treatments (OMT). To address this deficit, this study is designed to~     systematically evaluate the incidence and severity of OMT adverse events and examine the~     relationship of these adverse events to the technique(s) used and the body region(s) treated.~     The study is being conducted at the clinics of participating members of DO-Touch.NET, the~     only known practice-based research network (PBRN) focused on osteopathic manual medicine~     research. Eligible patients who receive OMT at one of the participating clinics will be asked~     to complete either a paper or online survey regarding any adverse events they experience~     within 1, 3, and 7 days following their treatment. Information regarding their diagnoses,~     which osteopathic techniques were used in their OMT, and which body regions were treated will~     be obtained from participant medical records. This data will be used to answer the following~     research questions:~        1. What is the incidence of adverse events from osteopathic manipulative treatment?~        2. What types of adverse events occur following osteopathic manipulative treatment?~        3. Are there individual osteopathic techniques in particular body regions that have higher~          incidences of adverse events than other techniques or body regions?~        4. Is the incidence of adverse events higher for some patient conditions than others?~   "
90233|NCT02386072|"~     A study to identify factors that are associated with improved effectiveness in pharmacologic~     therapy of Overactive Bladder, from the patient perspective primarily measured by OAB-Q-SF~     (Overactive Bladder Questionnaire Short Form)~   "
90234|NCT02386059|"~     Vitreoretinal surgery is associated with a considerable incidence of postoperative nausea and~     vomiting (PONV), which is reported to be as high as 60%. Reasons for this high incidence may~     be the long duration of surgery and anesthesia and the high degree of manipulation of the~     eye. Postoperative vomiting after vitrectomy is an important risk factor for the onset of~     several complications, such as suprachoroidal hemorrhage, with disastrous visual~     consequences.~      To date there is no evidence as to the possible protective effect of anti-emetic therapy with~     regard to interventions of vitrectomy performed under local anesthesia.~      In this prospective, randomized, multicenter, double blind study, we evaluated the efficacy~     of Ondansetron alone, Dexamethasone alone and in combination in controlling nausea and~     vomiting in patients undergoing vitrectomy under local anesthesia.~   "
90235|NCT02386046|"~     This study aims to determine normative values of oxygen saturation in late preterm infants,~     and evaluate the frequency of hypoxic events in infants requiring caffeine at discharge and~     those not requiring it.~   "
90236|NCT02386033|"~     ABSTARCT Background: Atorvastatin is an inhibitor of 3-hydroxy-2-methyl-glutaryl coenzyme A~     reductase. Lately, it has shown to have anti-inflammatory and bone stimulatory effects. The~     aim of the current study is to explore the effectiveness of 1.2% atorvastatin (ATV) as an~     adjunct to scaling and root planning (SRP) in the treatment of mandibular degree II furcation~     defects.~      Method: A total of sixty subjects were randomly assigned to two treatment groups. 1. SRP plus~     placebo gel 2. SRP plus 1.2% ATV gel. Clinical parameters like probing depth (PD), relative~     vertical clinical attachment level (RVCAL) , relative horizontal clinical attachment level~     (RHCAL), modified sulcus bleeding index (mSBI) and site specific plaque index were recorded~     at baseline and then at 3, 6 and 9 months. The radiological assessment of bone defect fill~     was done at 6 and 9 months, using a computer-aided software.~   "
90237|NCT02386020|"~     The present study is designed to investigate the effectiveness of AV gel local drug delivery~     as an adjunct to scaling and root planing (SRP) in the treatment of subjects with chronic~     periodontitis (CP) and type 2 diabetes mellitus (DM).~   "
90238|NCT02386007|"~     The purpose of this study is to find optimum dosage of DW-3101 by evaluating efficacy and~     safety of each dosage group in Korean patients with acute and chronic gastric inflammation.~   "
90239|NCT02385994|"~     The purpose of this investigation is to evaluate safety and efficacy of the Cutera enlighten~     dual-pulse duration, dual-wavelength 532nm KTP/1064nm Nd:YAG laser for the treatment of~     melasma and lentigines on the face in Asian skin.~   "
90240|NCT02385981|"~     H-1: tcpO2U2 > tcpO2U1 H-0: tcpO2U2 ≤ tcpO2U1~   "
90241|NCT02385968|"~     The aim is to investigate if herniated nucleus material in lumbar disc herniations is~     infected with bacteria, and if so, to determine their prevalence (control group), and to~     determine if patients with pre-existing Modic changes type 1 have a higher incidence of~     bacterial growth in relevant lumbar disc samples than patients without Modic changes.~      A cohort of 15 patients with pre-existing Modic and 15 without-undergoing primary surgery~     will be examined.~   "
90243|NCT02385942|"~     The purpose of this study is to analyse utility and compatibility of U-health solution~     service based on mobile for chronic wound management.~   "
90244|NCT02385929|"~     The purpose of this study is to explore whether early initiated physical exercise concurrent~     with a swallowing and mouth opening exercise program will have a positive effect on~     swallowing function and other quality of life aspects in patients treated with radiotherapy~     for head and neck cancer. The investigators hypothesize that patients who complete the~     program will have improved swallowing function and physical function one year after~     completing their treatment compared to patients who do not participate in the training~     program.~   "
90245|NCT02385916|"~     According to the Canadian Cancer Society, 1 in 9 Canadian women will develop breast cancer in~     her lifetime and 1 in 30 will die. The single greatest risk factor of breast cancer is poor~     estrogen metabolism. EstroSense®/MD is a natural health product that promotes and supports~     healthy estrogen metabolism. It may increase the ratio of good estrogen to bad estrogen~     and potentially reducing the risk of breast cancer. For this proposed study, the~     investigators will be examining the effect of EstroSense®/MD compared to placebo, on estrogen~     metabolism in 120 women.~   "
90246|NCT02385903|"~     Ischemia of an area may lead to a necrotic wound. In lower limb, it especially happens in~     diabetic or artheriopatic patients. It can lead to an amputation need. Revascularization~     procedure cannot be provide in all cases. Flammacerium, by a crust training and its~     anti-inflammatory effect, could stabilize necrosis extension, avoid bacterial contamination~     and then improve some incapacitating symptoms like odor or pain. This product may allow to~     delay amputation ruling for patients on who this procedure is unsafe. During 6 months, the~     investigators evaluate Flammacerium against standard dressing procedure in necrotic wound of~     the lower limb in patients where no revascularization can be provide. The investigators~     observed its effect on amputation need, symptoms as pain, infection, wound aspect evolution,~     wound size decrease.~   "
90247|NCT02385890|"~     The objectives are to test the acute effects of different bagels containing pulse ingredients~     on: 1) post-prandial blood glucose, insulin and appetite for two hours, and 2) food intake~     two hours following consumption of pulse products.~      The investigators hypothesize that bagels containing pulse ingredients will lead to lower~     blood glucose, insulin, appetite and food intake responses compared to non-pulse bagels.~   "
90248|NCT02385877|"~     The purpose of this study is to perform first-in-human PET imaging studies of two new cardiac~     sympathetic nerve imaging agents, 4-[18F]fluoro-meta-hydroxyphenethylguanidine ([18F]4F-MHPG)~     and 3-[18F]fluoro-para-hydroxyphenethylguanidine ([18F]3F-PHPG).~   "
90249|NCT02385864|"~     Resistant hypertension is defined as uncontrolled blood pressure (BP ≥ 140/90mmHg) despite~     the current use of three or more antihypertensive drugs at full doses, including a diuretic.~     Obstructive Sleep Apnea (OSA) is at high risk for cardiovascular morbidity and is highly~     prevalent in patients with resistant hypertension.~      The prospective observational POP-ART study will assess the efficacy of continuous positive~     airway pressure (CPAP) treatment on BP in patients with resistant hypertension and collect~     data from usual care.~   "
90250|NCT02385851|"~     This is a randomized, double-blind, single-dose, 2-period crossover study in healthy subjects~     to assess PK, PD, and safety (including immunogenicity) of a single 6 mg subcutaneous (SC)~     injection of CHS-1701 compared with a single 6 mg SC dose of Neulasta®.~   "
90251|NCT02385838|"~     The purpose of this interventional study is to compare the impact of four different~     Front-Of-Pack (FOP) nutrition labels on purchasing intentions. This study is nested in the~     ongoing web-based prospective observational NutriNet-Santé cohort study, including on~     December 2014 around 150,000 participants. The investigators will perform a five-arm~     randomized trial where participants will be subjected to different FOP nutrition label~     formats: Guidelines Daily Amount (GDA), Multiple Traffic Lights (MTL), 5-Color Nutrition~     Label (5-CNL), Green Tick (Tick) and a 'no label' condition. The impact of front-of-pack~     nutrition labels on the nutritional quality of the shopping cart will be assessed.~     Participants from the NutriNet-Santé cohort study will be randomly assigned to one of these~     five experimental conditions according to their sociodemographic characteristics.~      Purchasing intentions will be assessed using an experimental web-based supermarket designed~     to look like a regular online grocery store. The supermarket includes 269 unique products~     divided into 4 categories: dairy products, processed meat/delicatessen, savory and~     breakfast/sugary products. Each category is then separated into specific products families~     like yogurt, milk, cheese, etc. for the dairy products category. Inside a food family, the~     selection of foodstuffs will be made to obtain a representative sample of the products~     commonly sold in French supermarket. For each type of products, at least two variants are~     proposed. Products are retailers or manufacturers branded. Categories of products that are~     not usually bought each week, or which are likely to be bought from different sources are not~     included on the web-based supermarket.~      Participants are asked to simulate a shopping situation: they have to select a week worth of~     food for their family among proposed products. If the user is not able to find a product~     he/she usually buy, the instruction is to select similar product among proposed ones.~      Information provided for each product is: name, price and the picture with the FOP label/or~     not according to the experimental condition to which the participant is allocated. A brief~     explanation of the FOP label used is also given.~   "
90252|NCT02385825|"~     This study seeks to determine the safety and immunogenicity of a series of 3 primary~     vaccinations and a booster vaccination of Recombinant ricin toxin A-chain 1-33/44-198 (rRTA~     1-33/44-198) vaccine (RVEc) at 10, 50, or 75 μg IM. This study is evaluating if RVEc will~     display an acceptable safety profile as determined by adverse event (AE) data and if RVEc~     will elicit anti-ricin antibody titers and ricin toxin-neutralizing antibodies in vaccine~     recipients.~   "
90253|NCT02385812|"~     Asbestos defines a group of naturally occurring mineral silicate fibers which are easily~     inhaled, resulting in a variety of diseases of the respiratory system including lung cancer~     and malignant mesothelioma. Despite some advances in treatment, there has been little impact~     on overall survival for both lung cancer and mesothelioma in the past 20 years in great part~     because patients usually present with disease at an advanced and incurable stage. This study~     aims to develop and implement a low-dose computed tomography (LDCT) screening approach for~     lung cancer and mesothelioma in asbestos-exposed workers in Alberta.~   "
90254|NCT02385799|"~     This study is a control trial of sertraline (Zoloft) in children aged 2 to 5 years old~     inclusive with Autism Spectrum Disorder. The trial is six months long, and each participant~     will receive a series of tests at both the beginning and end of the study. The researchers~     hope to show improvements in language and social deficits.~   "
90255|NCT02385786|"~     This study will investigate the efficacy of an 8-week course in Mindfulness-Based Cognitive~     Therapy (MBCT) for adults with major depressive disorder (MDD) by ;measuring change from~     baseline to completion of treatment at 8 weeks in terms of depression severity using the~     Hamilton Depression Ratings Scale. We will measure change in C-Reactive Protein, a measure of~     inflammation, over the same time period.~   "
92776|NCT02352779|"~     This randomized pilot clinical trial studies omega-3 fatty acid in reducing cancer-related~     fatigue in breast cancer survivors. Supplementation with omega-3 fatty acid may help reduce~     cancer-related fatigue in breast cancer survivors.~   "
90256|NCT02385773|"~     This trial will assess the impact of the nutritional product PTM202 on childhood diarrhea in~     Guatemalan children. The product is based on cow-milk colostrum and egg. The trial will~     enroll children between the ages of 6 months and 3 years and will assess the impact of the~     study nutrition product on the duration and severity of diarrhea and on weight recovery in~     the 4 weeks following the diarrheal episode. The investigators will be determining the~     etiology of the diarrhea episode to ascertain if the nutritional product works better for~     certain etiologies or has a non-specific benefit.~   "
90257|NCT02385760|"~     A multi-centre, double-blind, randomized, parallel group, placebo controlled efficacy and~     safety study of oral CTX-4430 for the treatment of moderate to severe facial acne vulgaris.~   "
90258|NCT02385747|"~     100 women with abnormal uterine bleeding (peri and postmenopausal) were subjected to~     transvaginal ultrasound , saline sonohysterography , Diagnostic hysteroscopy and fractional~     curettage followed by histopathological examination and immunohistochemical analysis for~     estrogen and progesterone receptors.~   "
90259|NCT02385734|"~     This study hypothesized that Concentrated Growth Factors'(CGF) placement together with~     Coronally Advanced Flap (CAF) may enhance the healing of soft tissues. Therefore, the aim of~     this study was to determine the clinical effect of CGF combination with CAF compared to CAF~     alone in the treatment of adjacent multiple gingival recessions.~   "
90260|NCT02385721|"~     Evaluated the incidence and characteristics of adverse events during the treatment for Kanarb~     tablet.~   "
90261|NCT02385708|"~     Use of 2% chlorhexidine gluconate cloths pre-operatively and daily post-operatively jaw line~     to toes will decrease surgical site infections (SSI) by 30% when compared to patients who~     receive routine standard of care (use of chlorhexidine cloths night before surgery and~     morning of surgery).~   "
90262|NCT02385695|"~     The purpose of this study is to compare outcomes of (i) surgical treatment with posterior~     dynamic stabilization and (ii) surgical treatment with internal fixation and fusion in~     patients with multilevel lumbar degenerative disk disease.~   "
90263|NCT02385682|"~     The purpose of this registry is to evaluate long-term clinical events in patients with acute~     myocardial infarction who were treated with percutaneous coronary intervention.~      Although numerous articles have been published by using nationwide Korean myocardial~     infarction registries, such as the Korea Acute Myocardial Infarction Registry (KAMIR),~     limitation of previous registries is that these have little data beyond the first year of MI.~     Therefore, current registry was designed to assess long-term clinical events in patients with~     acute myocardial infarction.~      Because most of myocardial infarction patients were treated by revascularization in real~     world of Korea, this registry limits the inclusion criteria to patients who were treated with~     percutaneous coronary intervention to reduce the bias.~   "
90264|NCT02385669|"~     This study evaluates whether it is safe to administer a peptide vaccine with ipilimumab. This~     study will also evaluate the effects of the combination of the peptide vaccine and ipilimumab~     on the immune system. The investigators will monitor these effects by performing tests in the~     laboratory on participants' blood, a lymph node, and tumor samples.~   "
90265|NCT02385656|"~     Open-pilot study for the efficacy and tolerability of modafinil on the fatigue and somnolence~     in cancer-patients.~   "
90266|NCT02385643|"~     Background: Interactive and mobile technology to manage alcohol use problem potentially~     provide continuing care by offering emotional and instrumental support anywhere and in time,~     but the effectiveness for maintaining abstinence has not been examined. the investigators~     will evaluate in this study whether the smartphone-based support system would improve~     outcomes for people in recovery for alcohol dependence. To enable continuous self-monitoring~     and self-management, the phone support system prompts subjects to take Breath Alcohol~     Concentration (BrAC) tests using a phone application and a Bluetooth sensor unit. The system~     also offers instantaneous feedback, self-management strategies, and anonymous mutual social~     support from other subjects.~      Methods: This three-year project will be conducted in three stages, including pilot study,~     efficacy evaluation (12 week), and post-intervention follow-up (12 week) stage. Participants~     will be given a smartphone (if the subject does not have one), breathalyzer and training~     session. In the pilot study stage,10 subjects will be enrolled to validate the system. In the~     efficacy evaluation stage, the investigators will conduct a 12-week by enrolling 100~     post-detoxification alcohol dependent patients who are randomized to (1) standard treatment~     (ST) group or (2) standard treatment plus phone-based support group (technology intervention,~     TI group). Participants will be assessed by Time-Line Follow-Back (TLFB) to record the~     frequency and quantity of alcohol consumption, visual analogue for craving, Beck Depression~     Inventory (BDI) and Beck Anxiety Inventory (BAI), Satisfaction with Life Scale (SWLS), and~     Quality of life Scale (WHOQOL-BREF) and compared for outcome measures. After the 12-week~     trial, the investigators will take back the support system and follow the all subjects in~     both groups for another 12 weeks, i.e. post-intervention stage, to further understand the~     sustaining benefit from intervention. In addition, the investigators will identify the~     clinical variables or system factors that are associated with outcome measures.~      Expected results: In this study, the investigators expect that in treatment-seeking alcohol~     dependent patients, a smartphone-supported self-management program, adding on to conventional~     treatment, will be beneficial in improving the drinking outcomes such as a higher abstinence~     rate, a lower relapse rate, and a lower drinking frequency and quantity.~   "
90267|NCT02385630|"~     Surgery is the cornerstone of treatment for patients with oesophageal or gastric cancer, but~     while surgical removal of the tumour (oesophagectomy or gastrectomy) may offer the best~     chance of cure, these are major operations associated with specific long term complications.~     Weight loss and poor nutrition are relatively common problems among patients who attain~     long-term cancer remission and cure after surgery. The mechanisms underlying these problems~     are not well understood and therefore treatment options are limited.~      The investigators research has demonstrated increased levels of chemical messengers (gut~     hormones) released from the gastrointestinal tract after meals in patients who have~     previously undergone upper gastrointestinal surgery. These chemical messengers play a role in~     signalling the feeling of fullness during and after a meal (satiety). Understanding the~     mechanisms involved in increased gut hormone secretion after these operations may allow us to~     use certain medications to block gut hormone release and hence reduce satiety allowing~     patients to eat more, regain weight and prevent nutritional complications after surgery.~      Exaggerated post-prandial satiety gut hormone responses following oesophagectomy have,~     however, only been established cross-sectionally and therefore the time course for~     development of increased gut hormone secretion is unknown. Data collected from this study~     will provide important information about optimal timing of therapeutic intervention in this~     patient group, while offering mechanistic insights with regard to the pathophysiologic~     process underlying post-operative early satiety.~   "
90284|NCT02385409|"~     Preoperative anemia is an independent risk factor for the need for allogeneic transfusion~     during surgery and increased postoperative morbidity.~      Treatment of preoperative anemia is recommended. However the type of preoperative anemias in~     elective hip- and knee surgery has only been sparsely studied.~      This observational study aims to investigate the incidence and type of anemias prior to~     elective hip- and knee arthroplasty.~   "
90268|NCT02385617|"~     Improvements to treatment strategies for patients upper gastrointestinal cancers have~     produced an increasing population of people who remain free from disease recurrence in the~     long term. Weight loss and nutritional problems are common among patients who attain~     long-term remission and cure after surgery for upper gastrointestinal cancers. However, the~     mechanisms underlying these problems are not well understood. In this study the investigators~     aim to determine whether reduced food intake after upper gastrointestinal surgery is caused~     by early satiety related to exaggerated post-prandial gut hormone responses.~      This is a randomized, double-blind, placebo controlled, crossover study of the effect of~     100μg octreotide SC on ad libitum food intake in patients free from complications or~     recurrence at least one year post-oesophagectomy, gastrectomy or pancreaticoduodenectomy. A~     comparator group of age, weight and gender matched subjects will be studied concurrently, and~     caloric intake and subjective symptom scores after administration of octreotide versus~     placebo among surgical and comparator subjects will be assessed.~   "
90269|NCT02385604|"~     A major focus of research in oncology is to identify patients who, following induction~     therapy, have a complete pathologic response, presenting opportunities for novel trials,~     including extended therapy or non-operative approaches, in addition to identifying cohorts~     who are resistant to the neoadjuvant therapy. The current gold standard for determining~     response to CRT is pathological evaluation following surgical resection, in particular the~     Mandard Tumour Regression Grade (TRG) or some modification thereof. At this time, however,~     there is no preclinical early response or post-treatment biomarker, nor endoscopic or~     radiologic assessment that predicts pathologic response prior to surgical resection.The aim~     of this study is to determine the accuracy of CT-PET for prediction of histopathologic~     response and/or oncologic outcome for patients with esophageal cancer.~   "
90270|NCT02385591|"~     This research aims to investigate the effectiveness of an automated Simple Message Service~     (SMS, also known as text messaging) advisor system relative to a proven human advisor program~     to promote regular, sustained physical activity among inactive, overweight Latinos. The SMS~     Advisor program represents a potentially lower-cost and high yield alternative to~     person-delivered health promotion programs that could be more rapidly disseminated with~     greater and faster uptake.~   "
90271|NCT02385578|"~     AIM Verified if the first stage of the Train the trainer (TTT)plan could improve the young~     endoscopist's ability to detect the early gastric cancer（EGC）.~      METHOD~        1. a retrospective analysis of the ten young endoscopist's painless gastroscopy examination~          from January 1, 2014 to December 31, 2014. According mainly to the endoscopic report and~          pateint's History, quantity of gastroscope, gastric cancer and the early gastric cancer.~        2. the first step of the train the trainer plan(TTT) activised in March 19-20,2015,which~          including the diagnosis and operation hand in hand teach by Professor Yano~          Takeshiin,and the case discussion,and so on. Five young endoscopist accepted the TTT~          plan and the other five not accepted.~        3. The five doctors who accepted the TTT do the gastroendoscopy in accordance with the TTT~          content (for the T1 period),.(1) the patient's name, (2)gender, (3)age,(4)past medical~          history (Helicobacter pylori<HP>, gastritis, gastric ulcer, oral drug operation,~          etc.),（5）gastroscope operation time,(6)the location of the lesion- longitudinal (upper,~          middle and lower),(7) the location of the lesion -circumferential (lessor curvature,~          Greater curvature, anterior wall, posterior wall),(8) lesion size, (9)conventional~          white-light imaging (red, white, no change), (10)magnifying endoscopy with narrow-band~          imaging (EM-NBI) microvascular and mirosurface pattern VS classification system(VSCS)~          (boundaries, microvascular pattern and microsurface pattern; don't do it),~          (11)microscopy types (uplift type, flat type, concave type or IIc I/IIa or IIb),~          (12)histological type (differentiated and undifferentiated type) and (13) pathological~          (low grade neoplasia, high-level neoplasia etc.). For the treatment of endoscopy~          submucosal dissection (ESD) patients, further pathological results were recorded after~          ESD, including the pathology, edge and basal conditions. The other five doctors do the~          gastroendoscopy as they do before. (300 cases / person)~        4. 2-4 TTT activity ;The five doctors who accepted the TTT do the gastroendoscopy in~          accordance with the TTT content (for the T2-T4 period),.The other five doctors do the~          gastroendoscopy as they do before.~        5. Statistics the number of early gastric cancer have been found by the five young doctors,~          and how mang gastroscopy they have done.pay attention to The rates of EGC detection.~   "
90272|NCT02385565|"~     The aim of the present study is to compare Resting Energy Expenditure (REE) between normal~     fat diet (NFD) as a control vs high fat diet (HFD) as a treatment in Mitochondrial~     cytopathies disorders ( MID's ) patients. Secondary objectives is to compare diet induced~     thermogenesis (DIT) and body composition between NFD vs HFD.~      This study is a randomized cross-over study. Normal fat diet (ie 10 % proteins, 45 % lipids,~     45 % carbohydrates) is the imposed diet at baseline, high fat diet (ie 10 % proteins, 30 %~     lipids, 60 % carbohydrates is used according to the cross-over design trial. Main evaluation~     criteria is REE and second evaluation criteria is DIT both measured by indirect calorimetry~     ). 36 included MID subjects will be included in this study. Main evaluation criteria and~     second evaluation criteria will be measured at baseline, 1 month, 2 month and 3 month.~   "
90273|NCT02385552|"~     The purpose of this study is to determine clinical factors affecting quality indicators of~     colonoscopy including adenoma detection rate, and whether quality of colonoscopy could be~     elevated by improving related factors.~   "
90274|NCT02385539|"~     To find the optimal dose and combination of small dose of Levobupivacaine (LB) coadministered~     intrathecally with Fentanyl (F) or Sufentanil (S) with the highest probability for not~     developing hypotension and the lowest opioid side effect that would be sufficient to achieve~     and maintain a sensory block to the tenth thoracic dermatoma (T10) in elderly patients for~     surgery lasting > 45 minutes as compared with large dose of Levobupivacaine alone.~   "
90275|NCT02385526|"~     Post-market, on-label, double-blind, randomized, prospective, interventional, tolerability~     and clinical outcomes study to determine the number of patients achieving their final~     assigned VNS Therapy dose settings in patients with drug-resistant epilepsy who are being~     treated with adjunctive VNS Therapy using new titration protocols.~   "
90285|NCT02385396|"~     The purpose of this study is to analyse the activity of myo-inositol on pregnancy rate,~     embryo development dynamics and oestradiol and progesterone concentration in blood serum and~     Superoxide Dismutase (SOD) and catalase concentration in follicular fluid of patients with~     Polycystic Ovary Syndrome (PCOS) undergoing Intracytoplasmic Sperm Injection (ICSI).~   "
90286|NCT02385383|"~     This observational study follows a cohort of patients scheduled for elective hip- or knee~     surgery but has preoperative anemia and are treated with Intravenous (IV) iron prior to~     surgery according to a recently introduced standardized treatment protocol at 6 high-volume~     surgical centres.~   "
90391|NCT02384018|"~     The purpose of this study is to show safety and tolerability to our mesenchymal stromal cells~     (MSCs) product which will be autologous in nature, expanded using a non-xenogeneic, human~     component expansion media (pooled human platelet lysate) and delivered fresh. Subsequently,~     the investigators intend to test whether infusion of MSCs immediately after islet autograft~     can reduce onset of diabetes and improve glycemic control after total pancreatectomy and~     islet autotransplantation.~   "
90276|NCT02385513|"~     A single centre open-label, parallel group, randomised controlled trial, recruiting healthy~     Nepalese infants aged 40-60 days, who present to the immunisation clinic at Patan Hospital,~     Kathmandu, Nepal, randomised to receive a 10-valent pneumococcal conjugate vaccine (PCV10) at~     either;~        1. 6+10 weeks and 9 months OR~        2. 6+14 weeks and 9 months The study will enroll 152 healthy Nepalese infants in each~          treatment arm (304 in total). Demographic and clinical data will be collected on an~          electronic case report form to allow monitoring remotely. Participants will receive the~          study vaccine according to their allocated treatment arm in addition to their other~          routine vaccines. The investigators will collect 3 blood samples for analysis of serum~          antibody responses to the PCV10 vaccine serotypes throughout infancy (see Table 1). The~          data collected will be analysed in order to determine whether the 6+10 schedule is~          non-inferior to the 6+14 schedule in generating immune responses against the vaccine~          serotypes above the ≥0•35μg/mL threshold. These data will then be used to inform~          decision-making around augmenting the currently recommended 6+14 schedule to a 6+10~          schedule in Nepal. The investigators will collect a nasopharyngeal swab at 2 time points~          to look at carriage of pneumococcus over time and to assess differences between the 2~          groups. This is of critical importance because much of the programmatic impact of PCV is~          ultimately conferred by reductions in carriage at the community level and indirect~          effects resulting from that nasopharyngeal (NP) protection.~   "
90277|NCT02385500|"~     Parkinson's disease (PD) causes several non-motor autonomic symptoms including lower urinary~     tract dysfunction. Their symptoms can be managed with antimuscarinics with variable efficacy.~     Fesoterodine offers a new therapeutic molecule to target the symptoms of urinary frequency,~     urgency and nocturia in this patient population. The purpose of this protocol is to compare~     the impact of fesoterodine to placebo on urinary urgency and nocturnal sleep problems in a~     heterogeneous population of PD patients in a cross-over fashion.~      A representative number of patients with baseline overactive bladder (OAB) symptoms and~     Parkinson's disease will be recruited to receive either the active drug or placebo for the~     first phase of eight weeks. The groups will then be crossed-over during the second phase of~     eight weeks. The main outcomes assessed will be the urgency episodes on a 3-day voiding~     diary, as well as the nocturnal sleep problems will be the Parkinson's Disease Sleep Scale~     (PDSS).~   "
90278|NCT02385487|"~     Type 2 myocardial infarction (MI) is defined as myocardial necrosis that results from an~     imbalance of myocardial oxygen supply and demand. Although type 2 MI is highly prevalent in~     patients with critical illness and strongly associated with mortality, the pathophysiology~     remains poorly understood. Inflammation is central to the development of atherosclerosis,~     plaque rupture, and other subtypes of MI, but the role of inflammation in type 2 MI and~     myocardial necrosis has not been defined. The investigators aim to to delineate the~     mechanistic role of inflammation in myocardial necrosis and type 2 MI complicating critical~     medical illness.~   "
90279|NCT02385474|"~     Background: Tooth decay in children (Early childhood caries, or ECC) is a common childhood~     disease. Poor dentition significantly affects the nutrition, growth, development and general~     health of children. Conventional dental care for ECC is neither affordable nor accessible,~     particularly for the disadvantaged communities. Silver diamine fluoride (SDF) is a safe,~     cost-effective caries-arresting agent that appears to conform to the World Health~     Organization's Millennium Goals. SDF is commercially available at 38% and 12%, and topically~     used yearly or half-yearly to arrest ECC. The SDF regimens used for ECC treatment lack an~     evidence base. Therefore it is necessary to find the most suitable SDF concentration and~     application interval to arrest ECC. The purpose of this randomised controlled trial is to~     compare the efficacy of two commercially available SDF solutions at pre-prepared~     concentrations of 38% and 12% when applied at yearly or half-yearly intervals over 36 months~     in arresting caries in primary teeth.~      Methods / Design: This double-blinded study has recruited 888 kindergarten children aged 3-4~     years with caries. The sample size is sufficient for the appropriate statistical analyses.~     The children were classified into high and low caries rates and equally allocated into four~     groups for the caries treatment:~      Group A - semi-annual application of 12% SDF; Group B - annual application of 12% SDF; Group~     C - semi-annual application of 38% SDF; Group D - annual application of 38% SDF. The children~     will be followed for 36 months in their kindergartens until they enter primary school.~     Clinical examinations at 6-month intervals will be conducted to assess whether the caries are~     arrested. Information on confounding factors, such as oral hygiene habits and the use of~     other fluoride agents, will be collected through a parental questionnaire at the baseline and~     follow-ups.~      Discussion: This study will help determine the most suitable SDF concentration and~     application interval to arrest caries in children. Because SDF use for caries arrest is~     painless, simple, and low-cost, it can be widely recommended and promoted for caries control~     in young children or those with difficulty accessing and affording conventional dental care.~     The applicability of the findings and their impact on public health would be immense.~   "
90280|NCT02385461|"~     The occurrence of a spontaneous fetal loss (FL) is a rather frequent event: it has been~     estimated that up to 15% of pregnancies result in a fetal loss. However, recurrent events,~     defined as >2 or >3 loss, depending on the guidelines used (American College of Obstetricians~     and Gynecologists or Royal College of Obstetricians Gynaecologists guidelines), occur in 1 %~     of all pregnancies and it is noteworthy that Recurrent Fetal Loss ( RFL) in about 30-40% of~     cases remain unexplained after standard gynaecological, hormonal and karyotype~     investigations. Furthermore, it is important to consider that chromosomal abnormalities are~     responsible for at least 60% of FL in the first trimester, thus an abnormal karyotype in the~     fetus should be excluded prior to consider testing women for genetic susceptibility to~     placental vascular complications (inherited thrombophilia).~      Common inherited conditions, the factor V Leiden (FV) and the factor II G20210A (FII)~     mutations have been recognized as risk factors for FL.~      The efficacy of treatment with antithrombotic drugs during pregnancy in women with a history~     of RFL/ Intra Uterine Fetal Death (IUFD) and thrombophilia is still debated, due to scarcity~     of available data. Italian guidelines suggest the use of Low-Molecular-Weight Heparin (LMWH)~     in women with FV or FII mutations and previous otherwise unexplained obstetric complications,~     while guidelines released by RCOG suggest that heparin therapy during pregnancy may improve~     the live birth rate in women with second trimester loss associated with inherited~     thrombophilias. Hence, the idea to propose this prospective observational study comparing~     clinical data and outcomes in women with common inherited thrombophilias and in women~     without.~      During this study the investigators will collect and evaluate clinical data from examinations~     and visits by patients, eligible for the study as carriers of thrombophilic defects. This~     observation will begin before pregnancy and continue until the puerperium, allowing us to~     study all possible factors influencing these conditions. The study will add knowledge for~     improving feto-maternal prognosis and preventing spontaneous and recurrent FL.~      Plan of the study: multicenter observational study~   "
90281|NCT02385448|"~     The purpose of the study is to compare the recurrence of endometriotic cyst in patients~     taking Dienogest or Microgynon after conservative surgery.~   "
90282|NCT02385435|"~     The aim of this prospective randomized double-blind study was to compare the analgesic~     efficacy and the side effects of two doses of dexmedetomidine (1 and 2 µg.kg-1)~     co-administered with bupivacaine with bupivacaine alone for caudal analgesia in children~     undergoing infra-umbilical surgery.~   "
90283|NCT02385422|"~     To compare the efficacy and safety of Carvedilol and Propranolol in patients with~     cirrhosis-related esophagogastric varices after multiple endoscopic treatments for secondary~     prophylaxis.~   "
90314|NCT02385019|"~     Phase 1/2 clinical study for the treatment of steroid-refractory chronic graft versus host~     disease after an allogeneic transplant of hematopoietic progenitors with donor~     CliniMACS-selected regulatory T cells~   "
90287|NCT02385370|"~     Patients with advanced glaucoma that are candidates for trabeculectomy will be included.~      Thorough ophthalmic examination including best corrected visual acuity, slit lamp~     examination, intraocular pressure (IOP) measurement, gonioscopy, funduscopy and specularly~     microscopy will be performed for all participants. Patients will be assigned randomly to 2~     groups. In one group they will undergo fornix based trabeculectomy with conventional MMC~     0.02% soaked sponges application. In the other group 0.1 cc of 0.01 MMC will be injected into~     the tenon at the beginning of the surgery. The rest of the operation is the same for both~     groups as standard trabeculectomy. Ophthalmic examination including IOP measurement will be~     performed at one, 3 and 6th month post surgery. Specular microscopy will be requested at~     final follow up visit. Bleb morphology will be scored according to Indian grading system at~     3rd and 6th months post surgery.~   "
90288|NCT02385357|"~     There is no conclusive evidence about the effect of intake of protein-enriched drink after~     and acute high intensity exercise bout on muscle function and damage. The investigators aimed~     to study the effect of a protein-enriched drink on muscle function recovery following an~     acute high intensity exercise bout. The present counterbalanced, crossover, and double blind~     study will involve a total of 12 active men.~   "
90289|NCT02385344|"~     The purpose of the registry is to collect information regarding the number and type of~     coronary artery bypass (CAB) surgical procedure changes that are made based on intraoperative~     guidance information using transit time flow measurements (TTFM) and ultrasound image~     capabilities provided with the Medistim device.~   "
90290|NCT02385331|"~     Neutrophils play a central role in innate immunity and are rapidly recruited to sites of~     infection and injury. Neutrophil apoptosis and necroptosis are essential for the~     inflammatory.This study is designed to investigate the cells and the molecular mechanisms of~     neutrophil necroptosis and apoptosis.~   "
90291|NCT02385318|"~     The purpose of this study is to compare safety and efficacy of Perrigo's drug product~     compared to an FDA approved drug product in the treatment of actinic keratosis.~   "
90292|NCT02385305|"~     The aim of this prospective study is to determine the effect of pressure support ventilation~     (PSV) on minute alveolar ventilation (MAV) and end-tidal carbon dioxide (ETCO2) in~     anesthetized spontaneously breathing subjects by observing alterations of respiratory rate~     (RR), expiratory tidal volume, MAV and ETCO2 at variable levels of pressure support.~   "
90293|NCT02385292|"~     The objectives of this study are:~        -  To compare the change in levels of tear proteins and inflammatory mediators pre and post~          administration between the intranasal and extranasal applications~        -  To compare the goblet cell count following application between the intranasal and~          extranasal applications~        -  To compare fluorescein tear clearance with the application of the device intranasally~          and extranasally applications~   "
90294|NCT02385279|"~     The primary objective of this study is to compare the performance of MISTENT to that of~     XIENCE in an all-comers patient population with symptomatic ischemic heart disease. The~     patients will be followed through 3 years for major clinical events.~   "
90295|NCT02385266|"~     The purpose of this study is to evaluate the efficacy of D-Cycloserine versus placebo~     treatment in reducing pain from urological chronic pelvic pain syndrome (UCPPS).~   "
90296|NCT02385253|"~     This is a four-phase educational intervention for primary care practitioners (PCPs) to~     perform opportunistic melanoma surveillance. Based on prior research, the investigator will~     develop an interactive melanoma early detection skills training program for PCPs according to~     the principals of mastery learning. The proposed educational intervention will improve~     practicing PCPs' knowledge, competence, confidence, and diagnostic performance regarding~     pigmented lesions and attitude concerning importance of skin surveillance. In addition, this~     research aims to examine the clinical proficiency of PCPs regarding pigmented lesions. The~     proposed educational intervention will reduce the percentage of benign lesions referred to~     dermatology.~   "
90297|NCT02385240|"~     To compare safety and efficacy of Perrigo's rosacea drug product compared to an FDA approved~     rosacea drug product in the treatment of facial erythema of rosacea.~   "
90298|NCT02385227|"~     This is a randomized, open-label, forced-switch, parallel, proof-of-concept study to assess~     exposure to biomarkers of tobacco exposure following short-term ad lib use of three blu~     e-cigarette products. The primary objectives of this study are to:~        1. Compare changes in selected urine and blood biomarkers of tobacco exposure within~          cohorts following a 5-day forced-switch from usual brand conventional combustible~          cigarettes to exclusive use of blu e-cigarettes, dual use of blu e cigarettes and the~          subject's usual brand combustible cigarette, or smoking cessation.~        2. Compare changes in selected urine and blood biomarkers of tobacco exposure among cohorts~          following a 5-day forced-switch from usual brand conventional combustible cigarettes to~          exclusive use of a blu e cigarette, dual use of a blu e-cigarette and the subject's~          usual brand combustible cigarette, or smoking cessation.~      The secondary objectives of this study are to:~        1. Compare changes in selected physiological endpoints affected by tobacco exposure within~          cohorts during a 5-day forced-switch from usual brand conventional combustible~          cigarettes to exclusive use of blu e cigarettes, dual use of blu e cigarettes and the~          subject's usual brand combustible cigarette, or smoking cessation.~        2. Compare changes in selected physiological endpoints affected by tobacco exposure among~          cohorts following a forced-switch to exclusive use of a blu e cigarette, dual use of a~          blu e-cigarette and the subject's usual brand combustible cigarette, or smoking~          cessation.~        3. Determine daily nicotine consumption from blu e-cigarettes following exclusive use of~          blu e cigarettes or dual use of blu e-cigarettes and the subject's usual brand~          combustible cigarette over a 5-day period.~        4. Assess the effectiveness of exclusive use of blu e-cigarettes or dual use of blu~          e-cigarettes and the subject's usual brand combustible cigarette to reduce the urge to~          smoke.~        5. Assess subject opinions of various characteristics of blu e-cigarettes.~        6. Assess the safety and tolerability of short-term use of blu e-cigarettes.~   "
90299|NCT02385214|"~     Patients with a primary invasive melanoma are recommended to undergo excision of the primary~     lesion with a wide margin. There is evidence that less radical margins of excision may be~     just as safe. This is a randomised controlled trial of 1 cm versus 2 cm margin of excision of~     the primary lesion for adult patients with a primary invasive cutaneous melanomas >=1mm thick~     to determine differences in the rate of local recurrence and melanoma specific survival. A~     reduction in margins is expected to improve quality of life in patients~   "
90300|NCT02385201|"~     This is a prospective, multi-center feasibility study of effectiveness and safety of the~     Senza System in subjects with chronic, intractable pain of the upper limbs and/or neck. Data~     at follow-up visits will be compared to Baseline data collected at the beginning of the~     study.~   "
90301|NCT02385188|"~     The purpose of this study is to evaluate the efficacy, safety and immunological response of~     topical 5% imiquimod cream for non-invasive vulvar Paget's disease.~   "
90354|NCT02384499|"~     -  Purpose: The investigators aimed to investigate the safety and efficacy in the treatment~          of fecal incontinence by injection of ALLO-ASC into the anal sphincter.~        -  Method~             1. Safety test of allogenic ASCs injection~             2. Efficacy test of allogenic ASCs injection~   "
90488|NCT02382744|"~     Patients undergoing foot and ankle surgery have the option of having a nerve block~     administered by their Anesthesiologist. The nerve block numbs the foot and results in less~     post-operative nausea and vomiting, and better pain control. Two different techniques for~     blocking the saphenous nerve to the foot have been described and are both commonly used at~     St. Paul's hospital. The goal of this study is to compare the success rates of these two~     techniques.~   "
90302|NCT02385175|"~     The Eustachian tube links the middle ear to the back of the nose and is designed to open to~     allow the pressure in the air-filled middle ear to be equal to external (atmospheric)~     pressure. In some people this system fails to work properly leading to abnormal pressure in~     the middle ear, and complications such as middle ear fluid ('glue ear') or damage to the ear~     drum. The abnormal function of the Eustachian tube is called 'Eustachian tube dysfunction'.~     An affected person may feel pressure, pain or other symptoms in their ear, and their hearing~     can be temporarily or permanently reduced.~      This study is designed to find out which of a number of simple tests is best at detecting if~     the Eustachian tube is performing normally. Both patient-completed questionnaires and~     clinical tests using specialist machines will be compared as a way of diagnosing Eustachian~     tube dysfunction.~      A group of adults aged 18 and above, and children aged 5-17 years with normal ears, and a~     similar group of people that are already known to have Eustachian tube dysfunction, will both~     take six different tests and complete four different questionnaires. The differences in the~     results between the group with ETD and the healthy group will be compared. The results for~     each test or questionnaire will be compared to see which is best at telling the healthy and~     Eustachian tube function groups apart, and therefore at diagnosing Eustachian tube~     dysfunction. The investigators will also look to see if a combination of one or more of the~     tests or questionnaires is best at diagnosing the disease.~      The results of this study hope to provide a test or combination of tests that can be used on~     a daily basis by ENT doctors. The assessment technique would also be helpful in researching~     and comparing new treatments for ETD.~   "
90303|NCT02385162|"~     Development of a new MS-based biomarker for the early and sensitive diagnosis of Glycogen~     Storage Diseases from plasma and saliva. Testing for clinical robustness, specificity and~     long-term stability of the biomarker.~   "
90304|NCT02385149|"~     This study investigates the health benefits of whole grain wheat on cardiovascular/~     cardio-metabolic health, including glucose metabolism, by means of applying a mixed meal~     challenge. This study also investigates the health benefits of whole grain wheat (WGW) on~     liver- and adipose tissue health and evaluates the potential of do-it-yourself (DIY) devices~     in quantifying health effects in a nutritional intervention study.~   "
90305|NCT02385136|"~     The purpose of this study is to evaluate the safety profile and efficacy of whole brain~     radiotherapy (WBRT) concomitantly with temozolomide (TMZ) in patients with brain metastases~     (BM).Patients with BM were randomly assigned to 30 Gy of WBRT with or without concomitant TMZ~     (75 mg/m2/d) plus two cycles of TMZ (200 mg/m2/d for 5 days).~   "
90306|NCT02385123|"~     This is an open label single arm observational study of longitudinal immunologic responses to~     influenza vaccine in healthy adult subjects. This study will enroll males and non-pregnant~     females, 18-49 years old. The subjects will be screened at enrollment with a history and~     physical exam and laboratory testing to ensure they are healthy enough to participate.~     Qualifying subjects will be vaccinated with an FDA approved seasonal inactivated influenza~     vaccine (IIV) according to the package insert. The study will enroll 10 healthy volunteers~     per vaccination season in years 1, 2 and 4 through 6 of this study, for a total enrollment of~     50 subjects. The primary objective of the study is to characterize HA-specific plasmablasts~     and memory B cells after influenza vaccination.~   "
90307|NCT02385110|"~     The goal of this clinical research study is to compare the effect of adding either~     alemtuzumab or tocilizumab to the drug combination of etoposide and dexamethasone in~     controlling HLH. The safety of the drug combinations will also be studied.~      This is an investigational study. Alemtuzumab, etoposide, tocilizumab, and dexamethasone are~     not FDA approved for the treatment of HLH. Etoposide is FDA approved and commercially~     available for the treatment of testicular cancer and lung cancer. Alemtuzumab is FDA approved~     and commercially available for the treatment of chronic lymphocytic leukemia. Dexamethasone~     is a steroid used to reduce inflammation. Tocilizumab is FDA approved and commercially~     available for the treatment of arthritis. The combination of alemtuzumab, etoposide,~     tocilizumab, and dexamethasone to treat HLH is investigational. The study doctor can explain~     how the drugs are designed to work.~      Up to 40 participants will be enrolled in this study. All will take part at MD Anderson.~   "
90308|NCT02385097|"~     This Study evaluate the non-inferiority of Test product (Chloroprocaine 2%) versus Reference~     product (Ropivacaine 0.75%) in terms of proportion of subjects with a successful block for~     distal upper limb surgeries, without any supplementation in the first 45 min (see definitions~     below), calculated from the time of readiness for surgery (complete sensory block).~     Successful block: anaesthesia adequate for the surgery (complete sensory block), without any~     supplementation in the first 45 min (even if surgery lasts for > 45 min), calculated from the~     time of readiness for surgery (complete sensory block). Supplementation: i.v. premedication~     or general anaesthesia or pre- or intra-operative systemic analgesia or additional local~     anaesthetic infiltration~   "
90309|NCT02385084|"~     The purpose of this study is to measure how much of the new LY2409021 tablet formulations get~     into the blood stream and how long it takes the body to get rid of them, compared to the~     current LY2409021 capsule formulation. In addition, the safety and tolerability of both the~     new and current formulations will be evaluated. Information about any side effects that may~     occur will also be collected. The study has two parts. Each participant may enroll in one~     part only. The study will last up to 8 weeks for each participant. Screening is required~     prior to the start of the study.~   "
90310|NCT02385071|"~     The purpose of this study is to assess the relative bioavailability (the extent to which a~     drug or other substance becomes available to the body) of simeprevir (SMV) following single~     dose administration of age-appropriate oral formulation candidates compared to the 150~     milligram (mg) capsule, and to assess the effect of food on the bioavailability of SMV~     following single dose administration of a selected age-appropriate oral formulation~     candidate.~   "
90311|NCT02385058|"~     The purpose of this study is to assess the efficacy and safety of the combination of~     mebendazole plus quinfamide for the treatment of intestinal helminthiasis and amoebiasis in~     Mexican population.~   "
90312|NCT02385045|"~     This study aims to assess whether iScan, an intra-endoscopic imaging technique is an accurate~     and reliable tool in detecting and characterising Helicobacter pylori (H pylori) and~     comparing this to standard endoscopic imaging with white light endoscopy (WLE), narrow band~     imaging (NBI) and histology.~   "
90313|NCT02385032|"~     The purpose of this study is to evaluate bioavailability of two formulations of ursodiol.~   "
90315|NCT02385006|"~     Type of study:Prospective, single-center, non-therapeutic, of routine care No randomization,~     no modifications of the usual care, study results are not available for the physicians in~     charge of the patient.~      Objectives:~        -  The main objective of this study is to evaluate the ability of the thromboelastogram~          (ROTEM®) to detect clotting disorders related to pancreas-kidney transplantation,~          comparing ROTEM ® profiles during the perioperative period of two different types of~          transplantation (kidney alone and simultaneous pancreas-kidney)~        -  The secondary objectives are:~             1. To assess the incidence and type of coagulation disorders during the perioperative~               period of these two types of transplantation~             2. To study correlation values between thrombolelastogram and standard coagulation~               parameters~      Population study:~        -  Evaluated group: 40 pancreas-kidney recipients~        -  Control group: 80 kidney recipients~        -  Recruitment periods: 24 months~        -  Patient Monitoring: 48 hours~        -  Total duration of the study: 36 months.~        -  Ethics: Study of routine care. Oral and written information given to patients.~          Validation of the study protocol by the local ethics committee (CPP Sud Est II: Protocol~          No. HCL / P 2012.727)~   "
90316|NCT02384993|"~     The purpose of the aeRobic Exercise and Cognitive Health (REACH) study is to understand how~     an aerobic exercise intervention might help promote brain health and cognition, thereby~     delaying the onset of clinical symptoms of Alzheimer's disease.~   "
90317|NCT02384980|"~     This study will take the first step to improve public health for millions of Americans with~     Peripheral Arterial Disease who have extreme difficulty walking due to leg pain. The~     investigators will assess a proof of concept, home administered, functional electrical~     stimulation (FES) system to resolve pain, improve walking, and enhance quality of life.~   "
90318|NCT02384967|"~     Phase II trial assessing the efficacy of a reduced dose strategy of darunavir to 400 mg/d in~     HIV-1 infected patients virologically suppressed under a once daily regimen including~     darunavir 800 mg/d and two nucleoside reverse transcriptase inhibitors (NRTI), to maintain~     the viral load lower than 50 copies / mL at 48 weeks of treatment.~   "
90319|NCT02384954|"~     This is a Phase I/II, open-label, multi-center, competitive enrollment and dose escalation~     study of ALT-803 in patients with relapse/refractory indolent B cell non-Hodgkin lymphoma in~     conjunction with rituximab.~   "
90320|NCT02384941|"~     This Phase 3 study is intended to demonstrate superiority of either Sotagliflozin High dose~     or low dose versus placebo on glycosylated hemoglobin A1C (A1C) reduction at Week 24 when~     used as an adjunct in adult patients with type 1 diabetes mellitus (T1D) who have inadequate~     glycemic control with insulin therapy.~   "
90321|NCT02384928|"~     This trial will evaluate the comparative clinical effectiveness of pharmacopuncture for~     severe non-acute sciatic pain patients diagnosed with lumbar disc herniation (LDH) with usual~     care of conventional medicine and that of Korean medicine (acupuncture). Sixty patients with~     severe non-acute sciatic pain patients diagnosed with LDH (NRS ≥5, 4 weeks - 6 months) will~     be recruited, and randomized 20 each to the Shinbaro pharmacopuncture, acupuncture, and usual~     care group, respectively. The 2 acupuncture groups will receive 2 sessions/week of~     acupuncture alone or with pharmacopuncture for 4 weeks, and the usual care group will receive~     conventional medication 2 times/day and 2 sessions/week of physical therapy. Post-treatment~     evaluations will take place 5, 7, 9, and 12 weeks after randomization.~   "
90322|NCT02384915|"~     The aim of the study is to compare the time of home discharge in day-case patients receiving~     either a spinal anesthesia or a combined sciatic-femoral nerve block for knee arthroscopy~   "
90323|NCT02384902|"~     low GI and low GL diet have more beneficial effect for diabetic nephropath patients compared~     with conventional diet.~      low GL may have more favorable effect than low GI diet.~   "
90324|NCT02384889|"~     This study is a multicenter, double-blind, placebo-controlled, 2:1 randomly assigned, phase 1~     clinical trial for individuals with type 1 diabetes. It is a blinded dose-ranging study~     enrolling patients with new onset type 1 diabetes with documented continued residual~     C-peptide production. After a 4 week screening and run-in period during which eligibility~     will be determined and glycemic control optimized, subjects will have a 3-month double-masked~     treatment period with either DFMO or placebo. After a 3 month wash-out period the durability~     of effect will be assessed. Subjects will be randomly assigned (6 to DFMO; 3 to placebo in~     each cohort) to 1 of 4 sequential dose cohorts.~   "
90325|NCT02384876|"~     The incidence of arterial hypotension under general anesthesia using sevoflurane is~     particularly high in newborns and infants up to 6 months of age. A decrease of 20% of the~     initial mean blood pressure (mBP) is the definition of significant arterial hypotension in~     adults and children. In adults, intraoperative arterial hypotension is associated with an~     increase of intraoperative mortality and a certain neurological morbidity. In infants under 6~     months of age, neurological disorders have been reported following general anesthesia.~     Neurotoxicity of hypnotics is often incriminated as should be the episodes of arterial~     hypotension.~      Current management of hypotension uses vascular filling with crystalloids and vasopressive~     amines in second intention. Dopamine is the most frequently used amine. Ephedrine can also be~     used. Ephedrine is particularly interesting because of its action on both α and β receptors~     and its mode of administration: one dose and peripheral access.~      Only one study is available in children from birth to adulthood; it demonstrates a lower~     hemodynamic response in infants than in adults, when administered a low dose of Ephedrine~     (0.1 to 0.2 mg/kg). A recent retrospective cohort suggests an under efficacy of low doses and~     the use of higher doses than those recommended.~      The primary objective is to determine the optimal dose of ephedrine (dose of ephedrine~     associated with a difference of proportion of newborns/infants in therapeutic success of 55%)~     compare to the reference dose of 0.1mg/kg as a first line treatment of intraoperative~     arterial hypotension.~      Secondary objectives:~        -  Return to a mBP superior to 38mmHg post Ephedrine administration.~        -  To assess occurrence of hypoxemic events during anesthesia.~        -  To assess tolerance of ephedrine. One hundred and twenty newborn and infants up to 6~          months of age will be recruited in 3 sites of the Rhone Alpes Auvergne area over 24~          months.~   "
90326|NCT02384863|"~     The purpose of this study is to describe the characteristics, evaluation, management and~     outcomes of acute chest pain, and to provide opportunities for future initiatives to improve~     the emergency care for patients experiencing acute chest pain in China.~   "
90327|NCT02384850|"~     This trial will evaluate the combination treatment of established chemotherapy regimen~     mFOLFOX6 with Selinexor, an oral Selective Inhibitor Of Nuclear Export, in patients with~     metastatic Colorectal Cancer. The purpose is to determine the maximum tolerated dose (MTD) of~     selinexor in combination with mFOLFOX6.~   "
90365|NCT02384356|"~     The purpose of the study is to gather baseline surveillance data about the current health~     status of adults with chronic health conditions in La Paz and El Alto, Bolivia and identify~     barriers to the management of NCDs during face-to-face outpatient encounters as well as via~     novel mobile health services.~   "
90328|NCT02384837|"~     Although drug-eluting stents have reduced rates of restenosis and late lumen loss compared~     with bare metal stents, late stent thrombosis (LST), a life-threatening complication of this~     technology, has emerged as a major concern. Researches indicated incomplete neointimal~     coverage of stent struts as the most important morphometric predictor of LST. Pathological~     research showed stenting disruption of adjacent vulnerable plaques can precipitate LST,~     Meanwhile, thin-cap fibroatheromas (TCFA) as the most important predictor of Major Adverse~     Cardiovascular. Therefore, there is a hypothesis that TCFA may impair intimal healing which~     are prone to LST in vivo.~      Optical coherence tomography (OCT)is a high-resolution (<10 µm), catheter-based imaging~     modality capable of investigating detailed coronary plaque morphology in vivo.This study~     aimed to observe that TCFA will arise what of the effect on intimal healing of stent struts~     on the lesions which fractional flow reserve (FFR)≤0.75 after EXCEL biodegradable~     polymer-coated sirolimus-eluting stent was implanted at 9 months follow up: evaluated by OCT~     and FFR~   "
90329|NCT02384824|"~     The purpose of this study is to characterize the plaque morphology in patients with acute~     STEMI by OCT after aspiration thrombectomy.~   "
90330|NCT02384811|"~     The primary object of this trial is to evaluate the 2-year local control rate adding~     extensive clinical target volumes in postoperative radiotherapy for esophageal squamous cell~     carcinoma.~   "
90331|NCT02384798|"~     Due to the symptoms of heart failure (HF), as dyspnea and fatigue, patients have a reduced~     functional capacity, evidenced during usual daily activities and exercises. The Cardiac~     Rehabilitation with emphasis on resistance and aerobic exercises performed in the same~     session (concurrent training), can be added to pharmacological treatment as improvement~     strategy in functional capacity and quality of life.~   "
90332|NCT02384785|"~     Electrical stimulation therapy for pain reduction was performed already 2000 years ago. In~     recent years many studies had proved the effectiveness of electrical stimulation in pain~     management, tissue healing and muscle strengthening. Today there are devices with many types~     of currents. Each current comes with different statements for its effectiveness and its~     penetration depth yet there is no consensus on the most effective current in the dimension of~     penetration depth.~   "
90333|NCT02384772|"~     Survey to assess perspectives of patients prescribed IOP-lowering eye drops at a single~     office visit.~   "
90334|NCT02384759|"~     This is what the FFCD 11-01 - PRODIGE 25 trial proposes to study, as a preliminary for~     strategic studies evaluating the usefulness of including targeted therapeutics from the first~     line with aflibercept +/- LV5FU2.~   "
90335|NCT02384746|"~     Participants in this study will have been diagnosed with advanced breast cancer that has~     become worse while being treated with fulvestrant. Participants will have estrogen-receptor~     positive disease, and have completed menopause.~      There is information from research labs which suggests that drugs that work like MLN9708 help~     kill breast cancer cells that have been treated with fulvestrant. The purpose of the study is~     to determine the proper dose as well as the good and bad effects of MLN9708 when it is given~     in combination with fulvestrant. The Investigators also want to learn more about how the drug~     combination affects tumor cells.~      The amount of MLN9708 participants receive will be determined by when they enter this study.~     Three different doses will be given to different participants. The Investigators expect to~     enroll a total of 12-18 people.~   "
90336|NCT02384733|"~     The purpose of the study is to investigate the difference in late radiation morbidity between~     hypofractionated and normofractionated loco-regional breast irradiation irrespective of~     mastectomy or lumpectomy. In patients who a candidates for a boost, the boost will be~     provided as a simultaneous integrated boost.~   "
90337|NCT02384720|"~     The purpose of this study is to analysis PKPD of Freefol-MCT and to investigate relationship~     between the concentration of Freefol-MCT and the index which signaly analyzes those: EEG, EEG~     approximate entropy, systolic BP, saturation wave form and invasive BP wave form.~   "
90338|NCT02384707|"~     Reintroduction of small doses of food in allergic children to lightening the elimination~     diet.~   "
90339|NCT02384694|"~     The aim of this study is to examine the effects of a 12-week Zumba dance intervention on~     fitness, anthropometric and psychometric parameters and eating behavior.~   "
90340|NCT02384681|"~     Auditory monitoring of employees is currently based on pure-tone audiometry. However, this~     clinical examination does not prevent from deafness but established it a posteriori. From a~     preventive standpoint, it is important to detect hearing professional pain before the~     development of irreversible(s) clinical(s) symptom(s). The investigators' hypothesis is that~     auditory fatigue results from damages of primary and secondary central auditory pathways~     involving cognitive processes.~      The assessment of auditory fatigue includes the evaluation of speech intelligibility,~     short-term memory, working memory and perceived mental task load. The main objective of this~     study is to identify, among regulating medical assistants working with headset, a central~     auditory fatigue.~   "
90341|NCT02384668|"~     The purpose of this study is to investigate the effects of vitamin D supplementation on~     morbidity and risk of relapse in patients with Graves' disease.~   "
90342|NCT02384655|"~     Feeding human milk to preterm infants does reduce the risk of serious and costly neonatal~     intensive care unit acquired morbidity such as NEC and the late onset sepsis.~      It is often difficult to obtain sufficient quantities of human milk from mothers of preterm~     infants most of whom are breast pump-dependent for weeks or months. Mothers will try to use~     galactogogues in an attempt to increase milk production. Fenugreek (Trigonella~     foenum-graecum) seeds is the most commonly used herbal galactogogue and is a member of the~     pea family. Our experience at the NICU is that around 30% of preterm mothers desperately~     looking for ways to increase their breast milk supply will eventually took fenugreek (Hilbe)~     as food supplement. Although widely recommended, there is limited evidence to support the~     effectiveness of fenugreek as a galactogogue.~      The aims of this study are to evaluate whether maternal consumption of fenugreek seeds has~     any effect on macronutrients composition of breast milk and whether fenugreek is transferred~     to the infant via mother milk. In addition any changes in mother and infant health status~     will be assessed.~   "
90366|NCT02384343|"~     The purpose of this study is to determine whether dexmedotomidine is effective in the~     treatment of shivering associated with neuraxial anesthesia during cesarean delivery.~   "
90343|NCT02384642|"~     The study is a randomized controlled trial of COMPASS, an intervention for adolescent girls~     in Eastern Democratic Republic of Congo. The study design will employ a two-arm randomized~     controlled trial where girls will be enrolled at the same time and randomized to receive a~     basic package of services, which includes life skills education and access to mentors in safe~     spaces, or the basic package plus a structured parenting intervention for girls' caregivers.~     An experimental design will be used to evaluate the relative impact of the parenting~     initiative in addition to the safe space program for girls. In addition, qualitative research~     will address additional questions of acceptability, processes of change and best practice.~      Groups in North and South Kivu will be randomized so that every group is randomly designated~     as a group that will either roll out the core intervention or the intervention plus caregiver~     component. Groups that do not receive the parental intervention during the study will receive~     the intervention when the study is complete to reduce communal jealousies.~      The intervention, the COMPASS program, will involve a structured intervention for girls~     between the ages of 10-14 that is intended to engage adolescent girls, those who are~     influential in their lives, service providers and other stakeholders, with the ultimate goal~     of co-creating environments in which girls are valued and safe. The program is centered on~     establishing or supporting community-supported safe spaces for girls where they can come and~     gather among themselves and participate in a structured life-skills curriculum. In addition~     to the safe spaces for girls, the COMPASS project will also implement structured activities~     for the parents and caregivers of participants.~   "
90344|NCT02384629|"~     1. To compare the safety and efficacy of AXXESS stent with conventional DES in patients~          with coronary artery bifurcation disease~        2. To assess the impact of optical coherence tomography (OCT) guidance on clinical outcomes~          following the stent type~   "
90345|NCT02384616|"~     This study is aiming at assessing the effect of inspired oxygen fraction during general~     anesthesia on children's lung mechanics and volume. More specifically, the temporal change in~     end-expiratory lung volume (EELV) and respiratory system resistance and elastance during the~     perioperative period will be characterized in order to define the the effect of high inspired~     fraction of oxygen on lung function.~   "
90346|NCT02384603|"~     The aim of this study is to compare the effects of two physiotherapeutic treatments of~     fibromyalgia: global postural reeducation associated with cognitive behavioral therapy and~     segmental muscle stretching exercises associated with cognitive behavioral therapy.~   "
90347|NCT02384590|"~     Patients with sickle cell disease (SCD) experience significant depressive symptoms that~     currently go unrecognized and under-treated. Further, depression in this patient population~     has the potential to contribute to high health care utilization and poor disease outcomes;~     however, there are currently no comparative effectiveness studies of evidenced-based mental~     health treatments for depression in SCD.~      The primary objective of this study is to test the effectiveness of an online computerized~     cognitive behavioral therapy intervention to address psychological and behavioral needs of~     patients with sickle cell disease, namely depression and pain symptoms. The investigators~     will implement an existing computerized cognitive behavioral therapy (CCBT) program called~     Beating the Blues into routine clinical care at the University of Pittsburgh Medical Center~     (UPMC) Adult Sickle Cell Clinic to determine the effectiveness of this intervention in~     decreasing depression and pain versus treatment as usual. Patients with significant~     distress—depression and/or anxiety symptoms—will be randomized to either eight sessions of a~     CCBT program and weekly follow-up with a care manager or treatment as usual where the~     treating physician is notified of the patient's symptoms. The investigators will evaluate~     patient acceptability, implementation and practicality of the online mental health~     intervention through patient use of the site (frequency and duration of visits), qualitative~     interviews, and surveys. The investigators hypothesize: 1) the CCBT will be an acceptable~     mental health treatment for patients and easily integrated into routine clinical care; 2)~     patients in the treatment arm will show a greater decrease in depression/anxiety symptoms and~     average daily pain than patients in usual care.~   "
90348|NCT02384577|"~     The main aim of the study is to investigate patient satisfaction in the treatment of asthma~     and COPD with the new device of DuoResp® Spiromax® and patient preference. Possible~     difficulties in the use of the device under real-life conditions in clinical practice are~     investigated.~   "
90349|NCT02384564|"~     The purpose of this study is to determine whether there is a clinically relevant difference~     in first attempt success rates between the Ambu King Vision Video Laryngoscope and Direct~     Laryngoscopy in Children.~   "
90350|NCT02384551|"~     4-Arm Diet Intervention Investigating Effects of Dietary Carbohydrate Type and Amount on~     gastroesophageal pH, gastroesophageal reflux disease (GERD) symptoms and medication use.~   "
90351|NCT02384538|"~     This is a multicenter, randomized, double-blind, placebo-controlled study to compare the~     safety and efficacy of ABT-981 to placebo in subjects with erosive hand osteoarthritis.~   "
90352|NCT02384525|"~     Acute kidney injury(AKI) is one of the most common complications that occur up to 35% of~     critically ill patients. Septic AKI accounts for one third of them. Patients with septic AKI~     are widely treated with Continuous renal replacement therapy (CRRT). However, previous~     studies have hardly documented improvement of mortality in septic AKI patients. Otherwise,~     Fluid overload in septic shock patients who are undergoing CRRT is proven to be a significant~     predictor for mortality. Recent studies showed efficacy of bioelectrical impedance analysis~     and lung ultrasound in assessing fluid status of the patients. Thus, hypothesis of the study~     is that fluid assessment and control of fluid status using BIA and Lung Ultrasound could be~     related to the outcome of septic AKI patients who undergo CRRT. In this study, the~     investigators measure the fluid status of the patients by bioelectrical impedance analysis~     and lung ultrasound for experimental group, while for control group, fluid status would be~     determined clinically by the physician. Ultrafiltration rate of experimental group is~     adjusted to be equal to the value of overhydration measured by BIA.~   "
90353|NCT02384512|"~     End-of-dose fluctuations e. g. wearing-off are defined as a recurrence of motor and non-motor~     Parkinson's Disease (PD) symptoms that precedes a scheduled dose and improves with the next~     dose of anti-parkinsonian medication. Azilect® is approved and recommended for therapy of~     wearing-off-/End-of-dose fluctuations and improves motor fluctuations significantly in~     combination therapy with L-dopa and other parkinsonian medication.~   "
90355|NCT02384486|"~     This study aims to reduce stress in mothers of children with autism in Saudi Arabia. The~     researcher has designed a training programme for mothers whose children are young and just in~     their early stage at the autism organisations they are attending. The programme will include~     stress reduction tips, behavioural modification strategies for children with autism, and~     financial resources available to parents (how they can access government funding). The study~     will have two parts. Part one involves conducting an experiment by dividing the participants~     into two groups, one group will receive the training and the other group will wait until the~     end of the study then they will also receive the same training. Both groups will fill~     questionnaire at the beginning of the study, then after the first group finishes training,~     and then again 6 weeks later. Part two of the study will involve interviewing mothers of the~     first group who attended the training session. They will be interviewed by the researcher~     asking them about their experience with the training programme and their suggestions for~     future improvements. Mothers will be given a training manual at the beginning of the~     training. Training involves attending five sessions, one of which is a face to face session~     at the autism organisation their children are attending and the other four sessions will be~     through a Smartphone application called whatsapp which is widely used in Saudi Arabia.~   "
90356|NCT02384473|"~     This pilot clinical trial studies real-time contrast-enhanced ultrasonography and shear wave~     elastography in predicting treatment response in patients with soft tissue sarcomas.~     Ultrasonography and elastography are diagnostic imaging tests that use sound waves to make~     pictures of the body without using radiation (x-rays). Real-time contrast-enhanced~     ultrasonography and shear wave elastography may help measure a patient's response to~     treatment given before surgery in patients with soft tissue sarcoma.~   "
90357|NCT02384460|"~     The aim is to assess the efficacy and safety of SD-101-6.0 cream versus SD-101-0.0 (placebo)~     in the treatment of patients with Epidermolysis Bullosa. Funding Source - FDA OOPD~   "
90358|NCT02384447|"~     The investigators are proposing to conduct this study to compare the ultrasonographic~     appearance of the sciatic nerve with their corresponding histologic architecture. Patients~     that are scheduled to undergo above knee amputation due to complications associated with~     diabetes will be enrolled. We intend to do an ultrasound examination of the sciatic nerve at~     its bifurcation (about 4 inches above the knee). The investigators would mark the area on the~     skin where the image is obtained. Following surgery we will conduct a histologic examination~     of the nerve at the same site.~      Ultrasound examination is not standard of care, but is a fairly noninvasive procedure and~     does not add any risk to the subject. Histologic examination of the nerve is also not~     standard of care, but is conducted on a pathology specimen~   "
90359|NCT02384434|"~     This single-arm phase I/II study establishes the safety and efficacy of low level laser~     therapy (LLLT) in order to mitigate radiation-induced dermatitis in patients underoing~     radiation therapy for head and neck squamous cell carcinoma (HNSCC). Additional objectives~     include assessment of patient-reported quality of life data, pain parameters and dermatologic~     quality of life responses. The target population is patients with histologically proven~     squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx who are~     candidates for either definitive or adjuvant therapy consisting of a chemotherapy regimen and~     concurrent radiation therapy.~      Patients are required to have a favorable performance status (KPS greater than or equal to~     70), have had no prior head and neck radiotherapy and be at least 18 years of age and able to~     provide consent. While receiving radiotherapy and a concurrent systemic regimen, patients~     will receive LLLT using a 69 diode probe with dual 660 nm and 850 nm wavelengths to at least~     nine treatment sites in the head and neck region for a duration of 60 seconds to each site.~     LLLT will be given three times in a week prior to, daily during the first week of, and at~     least twice weekly thereafter during radiotherapy.~      Information collected includes toxicity scoring and quality of life surveys. A retrospective~     matched-pair design will be used to assess the rate of grade III complications compared to~     patients treated previously without LLLT support, with an anticipated 20% reduction in the~     risk of grade III dermatitis.~   "
90360|NCT02384421|"~     Continuous deep brain stimulation (cDBS) is an established therapy for the major motor signs~     in Parkinson's disease. Currently, cDBS is limited to open-loop stimulation, without~     real-time adjustment to the patient's state of activity, fluctuations and types of motor~     symptoms, medication dosages, or neural markers of the disease. The purpose of this study is~     to determine if an adaptive DBS system,responding to patient specific, clinically relevant~     neural or kinematic feedback, is more effective than continuous DBS on the motor Unified~     Parkinson's Disease Rating Scale (UPDRS III) and specific phenotypic measures in Parkinson's~     Disease.~   "
90361|NCT02384408|"~     Healthy postmenopausal women, amenorrheic for 1-10 years, aged 45-60 years and in use of~     follicle stimulating hormone > 30 mille-International unit/milliliters (mIU/mL), will~     participate in the study.~      All women will be informed by a physician of the risks and possible benefits of Hormone~     Replacement Therapy (HRT).~      The continuous combined treatment with drospirenone 2 mg and 17β-estradiol 1 mg or tibolone~     1.25 mg will be administered for a 24-week period.~      Transvaginal ultrasound was performed to evaluate the thickness of the endometrium at~     baseline. At study end-point, an endometrial biopsy will be performed with a Pipelle~     endometrial sampler to examine histological and immunohistochemical parameters.~      Immunohistochemical detection of Bcl-2 protein, estrogen and progesterone receptors will be~     performed in stroma and glandular epithelium.~   "
90362|NCT02384395|"~     This is a multicenter, single arm, 96-week open-label study of the safety and virologic~     efficacy of fixed dose combination Dolutegravir/Lamivudine/Abacavir (DTG/3TC/ABC FDC)~     initiated during acute HIV infection (AHI).~   "
90363|NCT02384382|"~     The purpose of this study is to evaluate 18F-sodium fluoride positron-emission tomography /~     computed tomography (18F-NaF PET/CT) imaging as a method for determining treatment response~     in metastatic bone lesions in patients who are receiving enzalutamide for~     castration-resistant prostate cancer.~   "
90364|NCT02384369|"~     This is a randomized, double-blind, placebo-controlled study of SNC-102 in adult subjects~     with cPTSD, added to pre-existing treatment that includes prazosin with or without other~     psychotropic drugs.~      Subjects will be treated with SNC-102 tablets or matching placebo on a BID basis for 8 weeks.~     Subjects will be evaluated for the symptoms of combat-related posttraumatic stress disorder~     (cPTSD) as measured by the Clinician Administered PTSD Scale (CAPS-5), compared with the~     response to placebo.~   "
90367|NCT02384330|"~     This study aims to estimate the costs of botulinum toxin A utilization in standard practice~     for the treatment of upper limb spasticity post-stroke in Portugal.~      It will consider the three most used locally available brands of botulinum toxin A which show~     similar efficacy and safety profiles thus making it relevant to understand if choosing~     between one or another brand can depend directly on economic factors.~      The study will estimate direct and indirect drug-associated costs as determinant variables~     for the price of each drug and the standard drug dose used in clinical practice.~   "
90368|NCT02384317|"~     This is a pilot study to test safety, tolerability, and efficacy of CCX168 in reducing~     proteinuria in patients with Immunoglobulin A nephropathy and persistent proteinuria despite~     supportive therapy with a maximally tolerated RAAS blocker.~   "
90369|NCT02384304|"~     The purpose of this study was to determine whether a 10-week internet-based program based on~     cognitive behavioral therapy (CBT) is effective in the treatment of alcohol problems, and if~     having therapist guidance leads to greater effects.~   "
90370|NCT02384291|"~     This clinical study is designed to compare the regenerative outcome of using separately two~     different Xenografts during sinus floor augmentation.~      Aim of this prospective randomized-controlled clinical trial is to compare the regenerative~     results of Alpha-Bio's GRAFT Natural Bovine Bone versus commercially available bone graft~     after two-step sinus floor elevations by clinical and histological analysis.~      Clinical Parameters are wound healing parameters, radiological volume stability and implant~     survival rates. Histological parameters are based on a histomorphometrical analysis of~     trephine cores harvested in progress of implant bed preparation.~   "
90371|NCT02384278|"~     The purpose of this study is to determine whether internet based cognitive behavior therapy~     might be effective in the treatment of alcohol problems.~   "
90372|NCT02384265|"~     Diabetes is a major public health problem that is associated with substantial health~     disparities for African American women compared to African American men or white men and~     women. This project will incorporate a) new technology whose use is high among African~     Americans (cell phone text message reminders), b) support from social networks, and c)~     strategies from the emerging field of behavioral economics to encourage and support self care~     behaviors that lead to improvements in diabetes control.~      In Stage I of the study, the investigators conducted focus groups with women with diabetes~     and their family members and friends. The investigators used information from these groups to~     work with a team of community partners to develop recruitment protocols, prepare study~     documents (including flyers, Frequently Asked Questions sheets, and informed consent forms),~     and finalize participant surveys.~      In the next phase of the study the investigators will evaluate ways that friends and family~     members can use direct support and text messages to improve control of blood sugar for~     African American women with type 2 diabetes. A team of three people--the Person With Diabetes~     (PWD) and 2 friends or family members, also known as the Support Team Members (STMs)--will be~     assigned at random to one of two groups to compare approaches to improving control of blood~     sugar. Each team will receive information and resources on improving diabetes control and~     will be linked by a text messaging program. The intervention team will receive additional~     text messaging support that may help them improve the PWD's diabetes control.~   "
90373|NCT02384252|"~     The investigators aim to explore obese cardiomyopathy by studying contractile twitch force,~     sarcomere sensitivity to calcium and mitochondrial function in atrial myocardial samples of~     patients grouped according to their body mass index, i.e. normal weight, overweight and~     obese.~   "
90374|NCT02384239|"~     Approximately 70 patients with HR+ advanced breast cancer will be enrolled. All patients will~     receive either fulvestrant (500 mg IM every 2 weeks x 3 then every four weeks) or tamoxifen~     (20 mg PO daily by physician choice). Pre-menopausal women must be in chemical menopause.~      Arm 1 will receive palbociclib 100 mg qd, days 1-21 every 28 days. Arm 2 will receive~     palbociclib 125 mg qd, days 1-21 every 28 days. Restaging will be performed every 8 weeks.~     Therapy will be continued until PD or unacceptable toxicity.~      Patients will be randomly allocated in a 1:1 ratio to take either 100 mg or 125 mg of~     palbociclib. Randomized treatment assignments will be made by permuted blocks, generated by~     our collaborating statistician at Dana-Farber Cancer Institute.~   "
90375|NCT02384226|"~     Refine content and delivery of the mHealth delivered lifestyle intervention program through~     iterative testing with small groups of users who provide feedback through on-line~     asynchronous focus groups.~   "
90376|NCT02384213|"~     The main objectives of this study are: i) to investigate the incidence and prevalence of~     fatal and non-fatal heart failure (HF) following myocardial infarction (MI) and its evolution~     over time in men and in women; ii) to identify prognostic factors for developing HF in~     patients who had an MI.~   "
90377|NCT02384200|"~     When patients are going to have surgery to remove large kidney stones (percutaneous~     nephrolithotomy [PCNL]), it is not clear whether the patients benefit from a course of~     prophylactic preoperative oral antibiotics; currently both the use of prophylactic~     preoperative oral antibiotics and no prophylactic oral antibiotics are considered to be~     within standard-of-care.~      This study will randomize patients to preoperative prophylactic antibiotics or no antibiotics~     to determine if the use of preoperative prophylactic antibiotics decreases the postoperative~     risk of localized urinary tract infection (UTI) and/or systemic infection that started in the~     urinary tract (sepsis or urosepsis).~   "
90378|NCT02384187|"~     The frequent incidence of postoperative vomiting and severe pain in children undergoing~     adenotonsillectomy, may delay postoperative oral intake and increase the risk of dehydration.~     Postoperative nausea and vomiting (PONV) is of multi-factorial origin in this group of~     patients, with a reported incidence ranging from 23% to 73%.~      There is growing evidence that the perioperative administration of gabapentinin in adults is~     beneficial for preoperative anxiolysis, postoperative analgesia, reduction of postoperative~     nausea and vomiting, and delirium.~      Only few studies in literature explored the analgesic effects of preoperative gabapentin as~     premedication in pediatric population. However, the antiemetic effect of gabapentin in~     pediatric patients was not systematically investigated before.~   "
90522|NCT02382302|"~     This trial is a prospective research to evaluate efficiency in U-health solution service~     based on Mobile for the chronic wound management.~   "
90379|NCT02384174|"~     The development of preventative nutritional strategies to promote healthy ageing is becoming~     increasingly important. Elevated thresholds for taste and smell, coupled with swallowing~     difficulties and masticatory dysfunction, often result in nutritionally imbalanced diets~     among the elderly. This can induce great changes in the composition and metabolic activities~     of the gut microbiome, leading to decreased intestinal motility and impaired bowel function.~     This can result in constipation or diarrhoea, increased basal levels of inflammation,~     immunosenescence and morbidity. The objectives of this study are to use dietary modification~     to improve gut health in older people. Diets high in resistant starch or dietary fibre will~     be given to 50 elderly volunteers (70-95 years) living in the community, in a randomised~     double-blind cross-over study. The aim is to investigate the effects on microbiome~     composition and functionality through fermentation, reduced putrefaction, and modification of~     blood markers associated with obesity and diabetes.~   "
90380|NCT02384161|"~     Isometric handgrip exercises are used to explain the effects of fatigue on the strength and~     activation of the muscles involved. Blood flow available at the time of exercise can~     influence this fatigue process, as some studies demonstrate changes in the pattern of muscle~     recruitment and strength recovery when the exercise is performed in combination with an~     external total obstruction (through a pressure cuff or tourniquet ) blood flow. Low intensity~     exercises associated with external partial obstruction of blood flow has been widely used and~     studied, mainly due to its effect on increasing strength and muscle hypertrophy, often~     comparable to those observed in conventional exercises (ie, without external obstruction of~     blood flow) High intensity. Despite the vast literature on this method, some topics need to~     be better informed about the underlying neuromuscular physiology to such effects (strength~     and hypertrophy) and the process of fatigue during isometric exercises associated with~     partial obstruction of blood flow. The aim of this study is to evaluate the acute effects on~     neuromuscular response in healthy adults undergoing an intermittent isometric exercise~     protocol with different levels of external compression. In a study of the crossover male~     volunteers will be submitted to three intermittent isometric exercise protocols (with a load~     of 45% of maximum voluntary isometric strength) associated with three different levels of~     obstruction (held by a pressure cuff) blood flow (total obstruction, partial obstruction and~     free blood flow). The protocols will be performed on three different days (with a minimum of~     48 hours between them). Will be considered as acute neuromuscular responses spending time to~     failure in the task, the electromyographic activity of the flexor muscles of the wrist and~     fingers, and the recovery curve of maximum voluntary isometric strength after exercise. The~     main hypothesis of this study is that exercise is performed when associated with partial~     obstruction of blood flow, the time spent until the failed job is similar to that seen when~     exercise is performed with free blood flow, and the recovery of strength and~     electromyographic activity will be similar to that observed in the exercise associated with~     total obstruction of blood flow.~   "
90381|NCT02384148|"~     The investigators aimed to characterize human circadian clockwork in healthy individuals in~     comparison to obese and type 2 diabetic subjects, employing the noninvasive experimental~     approach allowing the study of circadian profile in human individuals.~   "
90382|NCT02384135|"~     Prospective validation of an age-adjusted D-dimer cut-off to rule out deep vein thrombosis~     (DVT)~   "
90383|NCT02384122|"~     The purpose of this study is to determine whether long-acting octreotide is effective in the~     treatment of patients with refractory anaemia due to angiodysplasias.~      The hypothesis is that long-acting octreotide is effective in decreasing the blood and iron~     infusion requirements in those patients.~   "
90384|NCT02384109|"~     This proposed project will translate evidence-based strategies for diabetes prevention within~     the framework of an existing and highly utilized pharmacist-led diabetes care program. Our~     team includes investigators and practitioners with experience in implementing the DPP~     (Diabetes Prevention Program) as well as in community-based research. This proposal~     represents an opportunity to rapidly implement an innovative project addressing a critical~     area of significant unmet need, as the required key health system and community~     infrastructure are already in place. The intended outcome is the creation of a practical,~     effective and sustainable approach to increase evidence-based diabetes prevention strategies~     that can readily be adopted in other systems.~   "
90385|NCT02384096|"~     The study is a prospective, on-label, multi-center, blinded, randomized controlled trial with~     a cross-over design to evaluate the effect of Precision Spectra™ SCS System's programming~     features and lead options.~   "
90386|NCT02384083|"~     Phase I/II, Multicenter, Open Label, Clinical Trial to evaluate safety and efficacy and~     determine the Maximum Tolerated Dose (MTD) of Filanesib in combination with pomalidomide and~     dexamethasone in relapsed/refractory (R/R) Multiple Myeloma (MM) patients~   "
90387|NCT02384070|"~     Despite the routine use of procedural anti-coagulation and anti-platelet therapy for FFR~     calculation, no study has evaluated the optimal anti-thrombotic regimen in patients~     undergoing FFR. Therefore, the aim of the Evaluation of Simplified Anti-Thrombotic Therapy~     for Coronary Fractional Flow Reserve (SMART-FFR) study was to evaluate the safety of using a~     simplified anti-thrombotic regimen with only upstream dual anti-platelet therapy (DAT) with~     aspirin and clopidogrel, compared with anticoagulation plus single- or- DAT therapy in~     patients with intermediate coronary artery stenosis undergoing FFR calculation during~     elective coronary angiography.~   "
90388|NCT02384057|"~     C8 sciences program is a cognitive training program mainly developed for the students, and~     the effectiveness is well established. The aim of this trial is to assess clinical efficacy~     of the program for cognitive rehabilitation of the patients with stroke or brain injury.~   "
90389|NCT02384044|"~     This pilot study will evaluate the safety and effectiveness of a marketed sensitivity strip~     on existing dentinal hypersensitivity compared to a marketed sensitivity pen.~   "
90390|NCT02384031|"~     Post-dural puncture headache (PDPH) is the most common complication following lumbar puncture~     (LP). The frequency varies widely depending on a number of factors, among which patient~     characteristics, case ascertainment, gauge and type of needle used are of significant~     importance. In 2001, Strupp et al. showed that over 12 % of 115 patients who were subjected~     to diagnostic lumbar puncture with a 22 gg (0.7 mm) atraumatic needle suffered post-dural~     puncture headache, while over 24 % of 115 who were given a lumbar puncture with a 22 gg~     traumatic needle suffered a headache. This finding provided the basis for an American~     recommendation to use a 22 gg atraumatic needle for diagnostic lumbar puncture. A later study~     with 58 patients has shown an even greater difference (36 % versus 3 % post-dural puncture~     headache) when an atraumatic needle is used. Despite these findings, European Neurologist~     continue to hold on to the cutting needle. Here the investigators propose a prospective~     randomized study design with double masking; neither patient nor evaluator of PDPH aware of~     the needle design used, and with an active ascertainment of the occurrence of PDPH in~     accordance with updated headache classification guidelines. The investigators also intend to~     investigate whether specific neuroinflammatory substances and metabolites (different outcome~     variables) in the cerebrospinal fluid (CSF) will affect the explanatory variable.~   "
93863|NCT02338531|"~     This is a phase II open label Biomarker Research Study off PF-03084014 in non-metastatic~     triple-negative breast cancer patients with residual disease (cHEmoresistant) after~     completion of standard neoadjuvant chemotherapy.~   "
90392|NCT02384005|"~     There is no standard screening protocol for anal cancer even as disease incidence increases.~     This single-visit study will clarify if single persons can do a self-digital anal exam, or~     perhaps the exam requires a partner, or if, in fact, the exam requires a clinician for~     reasons of safety, accuracy, or acceptability.~      The investigators hypothesize that men having sex with men's digital anal exam (DAE) findings~     will have moderate or substantial agreement with a nurse practitioner DAE for detecting an~     anal abnormality (defined as condylomas, hemorrhoids, fissures, and malignant tumors). As a~     secondary hypothesis the investigator believe a partner-assisted DAE conducted within a~     couple will have better agreement with the nurse practitioner DAE than will a self-DAE~     conducted by a single person.~   "
90393|NCT02383992|"~     The primary objective of this study is to compare the efficacy of hydrogen peroxide versus~     normal saline in postoperative care of sutured wounds. Subjects will be randomly assigned to~     standard of care hydrogen peroxide or standard of care normal saline in postoperative care of~     sutured wounds followed by applying petroleum jelly and sterile gauze bandage. Data will be~     collected at day 0 and between days 7 to14. Subjects will provide irritation scale rating~     (0-4) with 0 being none/absent and 4 being severe/extreme.~   "
90394|NCT02383979|"~     Mirror therapy will consist of observing the unaffected limb reflected in a mirror positioned~     in the midline to block the view of the affected limb. All therapy sessions will be~     supervised by a physical therapist with the exception of weekends when the patients will~     continue therapy on an independent basis. In an effort to objectively demonstrate cortical~     reorganization associated with mirror therapy, patients can elect to participate in a~     functional MRI (fMRI) portion of the study. The fMRI would be evaluated prior to initiating~     the experimental or control therapy (Due to the sensitive timeline in this population and its~     effect on recruitment, we have amended the protocol to allow recruitment and enrollment to~     take place even if the timeline does not allow for the fMRI to be executed 2 weeks prior to~     amputation. Though this would be ideal, we will accept subjects that are only available for~     day before amputation scans), just before the operative procedure, at four weeks~     post-operation and then again at one year. All subjects will be evaluated at 4 weeks, 8 weeks~     (functional physical therapy (PT) tests only) 12 weeks, and 12 months postoperatively to~     determine 1) the incidence, severity and functional impact of phantom limb pain 2)the ability~     to meet various specialists' endpoints, to include participation in physical therapy, and 3)~     overall quality of life which the patients can describe subjectively. This therapy could have~     a dramatic impact on the long term prognosis of amputees whether due to trauma, metabolic~     conditions, tumor, or peripheral vascular disease.~      This protocol will include performing fMRIs on a cohort of healthy, active duty, age matched,~     male personnel to create reference data to compare the fMRI data of study participants.~   "
90395|NCT02383966|"~     This trial aims to assess efficacy and safety of cetuximab when given in combination with~     chemotherapy compared with chemotherapy alone in Chinese subjects with recurrent and/or~     metastatic squamous cell carcinoma of the head and neck (SCCHN) as the first-line treatment.~   "
90396|NCT02383953|"~     This study aims to investigate the role of non-genetic factors in the pathogenesis of~     inflammatory bowel disease.An exploratory study to investigate differences between the~     epigenome, microbiota and functional immunology in twins discordant for inflammatory bowel~     disease.~   "
90397|NCT02383940|"~     This Phase 2 study is intended to demonstrate superiority of Sotagliflozin versus placebo on~     A1C reduction at Week 12 in young adult patients with T1DM who have poor glycemic control on~     their current insulin regimen.~   "
90398|NCT02383927|"~     Phase II study to investigate the antitumor activity in terms of ORR of tipifarnib in~     subjects with advanced tumors that carry HRAS mutations and for whom there is no standard~     curative therapy available.~   "
90399|NCT02383914|"~     The purpose of the trial is to optimize the diagnostics of subscapularis tendon tears and as~     the circumstances require to found a new classification.~      The prime objective is a comparison of the conclusive of the clinic check-up, the sonographic~     and magnetic resonance tomography findings.~      The secondary objective is to detect the correlation of the outcome with the age , the~     gender, the pathogenesis and attendant injuries.~   "
90400|NCT02383901|"~     The purpose of this study is to investigate to which extend osteosarcoma patients do NOT meet~     the criteria for successfully advancement to next planned chemotherapy course.~   "
90401|NCT02383888|"~     To investigate the safety, tolerability and pharmacokinetics of BI 425809 tablets in healthy~     Chinese and Japanese male subjects following the administration of single rising oral doses~     and further to explore the pharmacokinetics (PK) including dose proportionality of BI 425809~     after single dosing of product.~   "
90402|NCT02383875|"~     The Opticourses project aims to improve the nutritional quality/price (NQP) ratio of the food~     purchases of people claiming to be facing financial problems. Following one of the main~     principles of the French National Nutrition and Health Program (PNNS), the project starts~     from the principle that to modify food consumption favourably and durably, one must act on~     both the demand and the supply (see figure). The demand part of the project is based on~     participatory workshops, and the supply part relies on intervention of social marketing in~     shops.~   "
90403|NCT02383862|"~     The purpose of this study is to determine the effectiveness of providing PROMIS Profile Scale~     scores (e.g., sleep, pain, anxiety, depression, energy/fatigue) to physicians on patients'~     symptoms.~   "
90404|NCT02383849|"~     P1106 is Phase IV prospective pharmacokinetic (PK) study of low birth weight infants who are~     receiving or will be receiving as part of clinical care nevirapine (NVP) prophylaxis,~     tuberculosis (TB) prophylaxis or treatment and/or combination antiretroviral (ARV) treatment~     containing lopinavir/ritonavir (LPV/r). The study is designed to describe the~     pharmacokinetics and safety of NVP, INH, RIF, and LPV/r in these infants receiving the~     drug(s) as part of clinical care.~   "
90405|NCT02383836|"~     Patients will have simultaneous Transesophageal Echo (TEE) and Transcranial Doppler (TCD)~     performed and a comparison of timing, sensitivity and intensity of intravenously injected~     bubbles will be determined.~   "
90523|NCT02382289|"~     Expecting using bipolar RF at six points, in spite of potentially consuming more~     intraoperative time, to be more effective and long lasting in the management of pain~     resultant from chronic sacroiliac joint arthropathy than the other 2 techniques using the~     monopolar RF even if using six points.~   "
90406|NCT02383823|"~     The study examines the effect of hormone replacement in postmenopausal women compared to men,~     55 years of age, and in the elderly without hormone replacement of both sexes. The lipid and~     glucose metabolism is evaluated during treatment and placebo with a meal with mashed potatoes~     and different types of fat. Glucose, insulin, triglyceride, total cholesterol, LDL and HDL~     cholesterol, free fatty acids and coagulation parameters are measured.~      During menopause the women reduce their levels of estrogen and their risk of cardiovascular~     disease rises to the men's level. This effect on mortality and morbidity can probably be~     reduced by hormone therapy.~   "
90407|NCT02383810|"~     This is a randomized, stratified, double-blind, double-dummy, parallel group,~     placebo-controlled, dose finding, multicentre, multinational, phase II study in patient with~     colorectal cancer receiving 5- Fluorouracil (5-FU)-based chemotherapy (FOLFOX or FOLFIRI).~     Patients will receive, starting from the day of chemotherapy administration, a single daily~     dose subcutaneously (s.c.) of elsiglutide 10, 20 or 40 mg or placebo for 4 consecutive days.~     Each patient will be in the study for 3 consecutive chemotherapy cycles. The treatment period~     for each patient will be 4 consecutive days at each of the first 2 chemotherapy cycles.~      The primary objective is to compare the efficacy of 3 s.c. doses of elsiglutide versus (vs.)~     placebo and vs. each other dose in the prevention of CID in colorectal cancer patients~     treated with 5-FU based chemotherapy (FOLFOX or FOLFIRI) with no addition of a monoclonal~     antibody.~   "
90408|NCT02383797|"~     The investigatoris will carefully select cartilage-hair hypoplasia patients unexposed to~     varicella (VZV) and immunize patients in a controlled manner with VZV vaccine. Patients will~     be selected on the basis of disease severity and the degree of immunodeficiency (including~     CD4+ T-cell counts). Any potential complication of VZV immunization, such as rash, will be~     discussed with the patients/caregivers beforehand and acyclovir will be used to treat any VZV~     related symptoms, consistent with the current practices. The investigators will verify the~     development of immune response to vaccination by testing for VZV antibodies and cell-mediated~     immunity.~   "
90409|NCT02383784|"~     Background/Aims: Verify the effects of glycemic index (GI) on body composition, and on~     inflammatory and metabolic markers concentrations. Methods: Eighteen type 2 diabetics, (aged~     42.4 + 5.1 years, BMI 29.2 + 4.8 kg.m-2) were randomly allocated to low GI (LGI) or high GI~     (HGI) groups. High or low GI meals were provided in the laboratory twice a day during 30~     consecutive days. The other meals were consumed under free living condition and subjects were~     instructed to select foods presenting GI values corresponding to the allocated group. Body~     composition (body mass index, body fat percentage, waist circumference and waist-hip ratio),~     and inflammatory markers concentrations (interleukin-6, tumor necrosis factor-alpha, high~     molecular weight adiponectin, ultra-sensitive C-reactive protein and fibrinogen) and~     metabolic markers (glucose, insulin, total cholesterol, HDL cholesterol, free fatty acids,~     triglycerides and fructosamine) were assessed at baseline and after intervention. Food intake~     was monitored during the study. The criterion for statistical significance was P<0.05.~   "
90410|NCT02383771|"~     The purpose of this study is to determine the proportion of untreated donor platelets~     required to fully reverse the platelet inhibitory effects of ticagrelor and aspirin in~     healthy persons and patients with coronary artery disease undergoing percutaneous coronary~     intervention (PCI) and receiving ticagrelor.~   "
90411|NCT02383758|"~     The purpose of this study is to try to treat bowel movement (BM) accidents differently with~     children with autism spectrum disorder (ASD). The study will use over-the-counter (OTC)~     medications to evoke predictable bowel movements. This will make it possible for~     investigators to use certain strategies to reward BMs in the toilet. Independence will be~     increased by fading out the use of medications. The investigators will also train caregivers~     to implement the procedures.~   "
90412|NCT02383745|"~     In Kuopio University Department of Clinical Neurophysiology there have been designed a fast~     EEG electrode, that is suitable for acute emergency use. It is easy to set up, records high~     quality EEG and can detect the most important EEG abnormalities comparable to conventional~     EEG. This study will address the clinical use of acute EEG with fast electrode set in~     in-hospital patients who have been consulted by Medical Emergency Team because of seizure or~     altered mental state of uncertain etiology. Patients are going to be treated in ICU and EEG~     monitoring will continue for 24 hours.~   "
90413|NCT02383732|"~     The purpose of this study is to demonstrate the feasibility of the Elopement Prevention~     Safety (EPST) program in children with autism spectrum disorder (ASD) who have engaged in~     eloping. This is a program created by the Behavior Treatment Clinics to help caregivers come~     up with a safety plan to prevent their children from running away or wandering off.~   "
90414|NCT02383719|"~     Evaluate the clinicians assessment of the use of an oro-nasal mask during non-invasive~     ventilation (non-intubated) with a feasibility study.~   "
90415|NCT02383706|"~     Obstructive sleep apnea (OSA) is a risk factor for complications during pregnancy and current~     screening tools for OSA have not been shown to be reliable in pregnant women. The primary aim~     of this study is to develop a valid screening tool to identify at-risk pregnant women, so~     that they can be further evaluated and treated. Women with OSA may also be at risk for~     respiratory complications related to opiate administration for post-cesarean delivery pain. A~     secondary aim of this study is to evaluate post-operative minute ventilation in women who~     undergo cesarean delivery using a novel method of non-invasive minute ventilation monitoring.~   "
90416|NCT02383693|"~     number of center : 1~        -  duration of study : 24 months~        -  recruitement time : 23 months~        -  Aim :Principal~      Evaluate the interest of maintenance rTMS in a one-year double blind randomized controlled~     study for TRD patients.~      Secondary~      Evaluate the impact of rTMS on cognitive functions.~   "
90417|NCT02383680|"~     Travelers (n = 30, 15 taking low-dose methotrexate (MTX), 15 healthy controls (HC), seeking~     travel advice in one of the following Swiss Travel Centers (Aarau, Basel, Bern, Geneva,~     Lausanne, Zurich) and who have an indication for yellow fever (YF) vaccination according to~     the Swiss Federal Office of Public Health's vaccination recommendations are invited to~     participate in this study. After signing the consent form (i) YF viremia and (ii) anti-YF~     antibody production in patients taking low-dose MTX and HC will be compared after YF~     vaccination. It will be analyzed whether the percentage of people with protective antibodies~     differs between the two groups and (iii) vaccine side effects will be compared between the~     groups.~   "
90418|NCT02383667|"~     The objective of the study is to compare electrocardiograms using ambulatory holter monitor~     with dry electrodes in a harness versus using an ambulatory holter with standard sticky~     electrodes (Red Dot) on monitored patients within the hospital. Patients will be~     simultaneously be hooked up to two ambulatory Holter monitors for the period of time to be~     not less than one hour. One holter will use standard electrodes in a standard electrode~     distribution. The second holter will use dry electrodes in a derived.~   "
90419|NCT02383654|"~     The purpose of the study is to determine the safety and possible effectiveness of Autologous~     Adipose-Tissue Derived Stem Cells treatment in a Amyotrophic Lateral Sclerosis(ALS) patient.~   "
90420|NCT02383641|"~     Development of a new MS-based biomarker for the early and sensitive diagnosis of Wolman~     disease from plasma and saliva. Testing for clinical robustness, specificity and long-term~     stability of the biomarker.~   "
90421|NCT02383628|"~     The main objective of the study is to evaluate the efficacy of indocyanine green (ICG)~     endoscopy to evaluate tissue perfusion during endoscopic neurosurgery. This includes patients~     with pituitary and intracranial tumors and treatment of vascular abnormalities such as~     aneurysms and compressive syndromes. ICG will be evaluated to determine the value of the~     additional visual information supplied during the treatment of these pathologies.~   "
90422|NCT02383615|"~     Saphenous nerve blocks can be technically challenging. Recently described ultrasound~     techniques have improved the success rate of saphenous nerve blocks, but randomized~     controlled trials comparing these techniques are lacking. The investigators compared two~     common ultrasound guided approach for saphenous nerve block: saphenous nerve block at the~     adductor canal (ACSNB) vs. block by the distal trans-sartorial (DTSNB) approach.~   "
90423|NCT02383602|"~     HIV counseling and testing, risk reduction counseling, provision of condoms and lubricants~     Same-day result HIV testing along with pre-test and post-test counseling, including risk~     reduction counseling, will be provided according to the standard practice at each study site~     at enrollment and every 6 months in HIV-negative participants. HIV-negative participants can~     also access non-occupational post-exposure prophylaxis service and symptomatic STD service if~     these are available at study sites. HIV-positive participants will also receive risk~     reduction counseling every 3 months. Condoms and lubricants will be provided free of charge.~   "
90424|NCT02383589|"~     This is a Phase III, randomized, double-blind, double-dummy, active-comparator, parallel-arm,~     multicenter study to evaluate the efficacy and safety of rituximab compared with MMF in~     participants with moderate-to-severely active PV requiring 60-120 milligrams per day (mg/day)~     oral prednisone or equivalent. Participants must have a confirmed diagnosis of PV within the~     previous 24 months (by skin or mucosal biopsy and immunohistochemistry) and evidence of~     active disease at screening.~      Approximately 132 participants will be enrolled at up to 60 centers worldwide. Participants~     will be randomized in a 1:1 ratio to receive either rituximab plus MMF placebo or rituximab~     placebo plus MMF. Randomization will be stratified by duration of illness.~      The study will consist of three periods: a screening period of up to 28 days, a 52-week~     double-blind treatment period, and a 48-week safety follow up period that begins at the time~     of study treatment completion or discontinuation.~   "
90425|NCT02383576|"~     This study aims to understand better the effective results from the IMELDA MO22223 P-trial~     (NCT00929240) and see if the anti-cancer therapies given during its follow-up time after~     study treatments were terminated possibly had an effect on efficacy results.~   "
90426|NCT02383563|"~     This proposal seeks to assess the impact of 24 weeks of metformin on non-calcified plaques~     and calcified plaques assessed by coronary CT angiography, and on whether these changes can~     be explained by metformin-induced phenotypic and secretory changes of monocytes.~   "
90427|NCT02383550|"~     This study is designed to demonstrate that Tysabri is effective in maintaining cognition in~     MS patients after 5 or more years of continuous treatment.~      During a second period of 36 months, the extension study will assess the evolution of~     cognitive function in Tysabri treated MS patients using the Symbol Digit Modalities Test~     (SDMT) and a CogState battery of tests.~   "
90428|NCT02383537|"~     The aim of the research is to study the effect of miRNA, fat tissue and insulin resistance on~     the pathophysiology of diabetes during pregnancy. During the study fat tissue, Umbilical cord~     blood, placenta tissue and subcutaneous fat will be taken from pregnant diabetic woman over~     going a C-section. Healthy pregnant women will serve as a control group.~   "
90429|NCT02383524|"~     The Investigators have designed this exploratory study in patients suffering from~     zygapophysial joint mediated pain to investigate if a correlation exists between~     inter-individual genetic variability (genotype) with treatment response (phenotype). More~     specifically, the investigators aim to identify any form of correlation between a specific~     SNP of the BDNF gene (Val66Met) and the effectiveness and/or duration of radiofrequency facet~     joint neurotomy. The study population is patients suffering from chronic low back pain who~     have been scheduled for radiofrequency neurotomy following the diagnosis of facet joint~     mediated pain (using medial branch block test). The investigators will evaluate if a common~     variant of BDNF gene (Val66Met) can be directly correlated to a significant degree of pain~     relief following RF treatment, and whether the result of such a procedure can be predicted~     from a specific genetic profile.~   "
90430|NCT02383511|"~     Placebo-controlled, multi-centre, randomized, double-blind dose escalation study. The aim is~     to evaluate the pharmacokinetics (PK) and safety of SMT C1100 in paediatric patients with~     Duchenne Muscular Dystrophy (DMD) who follow a balanced diet.~   "
90431|NCT02383498|"~     TRIAL SUMMARY~      Researchers at the National Cancer Institute (NCI) are now enrolling patients in a phase 2~     clinical trial to determine whether the yeast-brachyury vaccine GI-6301 improves the~     effectiveness of radiation for patients with localized chordoma. Chordoma patients with~     inoperable or residual tumor who do not have metastases and are planning to be treated with~     definitive (>70Gy) radiation are eligible to participate. Patients will initially be~     randomized to receive radiation plus the vaccine or radiation plus a blinded placebo. Those~     randomized to receive radiation plus placebo will have the option to receive vaccine if their~     tumor grows while on the study. The study will compare the outcomes of patients treated with~     radiation with and without the vaccine to determine whether the vaccine can increase the~     chances of shrinking the tumor and/or preventing further tumor growth.~      WHY THIS TRIAL IS BEING DONE~      The primary treatment options for chordoma currently consist of surgery and high dose~     radiation. Radiation has been shown to improve patient outcomes following surgery. Radiation~     is also sometimes used instead of surgery when surgery would carry unacceptable risks.~      The chance of tumor growth after radiation is significantly higher for patients who have~     residual tumor than for those whose tumor is completely removed. Unfortunately for patients~     with a tumor that cannot be completely removed, there tends to be a short time until the~     tumor grows back and eventually causes death. For this reason, our team at the NCI seeks to~     identify a therapy that can reduce the risk of recurrence and improve survival after~     radiation for patients who have residual tumor.~      One approach we are pursuing is treating patients with a therapeutic vaccine that is intended~     to stimulate the immune system to fight cancer cells that express the brachyury protein.~     Brachyury is present at very high levels in nearly all chordomas but is not present in the~     vast majority of normal tissues, making it a promising target for immune therapy. Research in~     other cancers suggests that radiation in combination with immune therapy can provide powerful~     antitumor effects.~      We have recently completed a phase 1 clinical trial of a therapeutic vaccine targeting~     brachyury called GI-6301 in which 11 chordoma patients participated. Through that phase I~     trial, we learned that this vaccine can be given safely without serious adverse reactions. In~     that study, the vaccine was also capable of inducing immune responses against brachyury and~     one patient had his tumor shrink more than 30% while on study. Some other patients (7 of 10~     evaluable) also had stable disease for more than 5 months while on study. However, these~     clinical findings are not definitive and further clinical testing is required to determine~     the benefit of this vaccine in chordoma. To that end, we have designed a larger phase 2~     clinical trial intended to determine if this vaccine, when given in combination with~     radiation, improves outcomes for patients with chordoma compared to those who only have~     radiation.~      WHO CAN PARTICIPATE~      We have designed this trial for patients who have residual tumor remaining after surgery, who~     are unable to have surgery, or who have a local recurrence following previous treatment.~      To be eligible for enrollment on this study, patients must:~        -  Have a confirmed diagnosis of chordoma~        -  Have only localized tumor (no metastases)~        -  Be able to receive at least 70 Gy of radiation to their localized tumor~        -  Be willing to travel to Bethesda, MD for treatment and follow-up visits~      HOW THE TRIAL WILL WORK~      The trial is taking place at the National Institutes of Health Clinical Center in Bethesda,~     MD. The NCI will pay for transportation costs (including airfare) and a portion of lodging~     costs for patients after enrollment in this study.~      The process of participating in the trial is as follows:~        -  Patients travel to NIH to receive injections of the vaccine (or placebo) every other~          week for three doses prior to starting radiation (approximately 4 weeks)~        -  Patients then complete their radiation treatment with their home radiation oncologist~          (typically over a 1-2 month timespan)~        -  Following completion of radiation treatment plan, patients travel back to NIH to resume~          vaccine (or placebo) injections every 2 weeks until 6 total doses have been given (3~          doses after radiation, another 4 weeks)~        -  At that point, doses spread out to every 4 weeks for 4 doses, and then 1 dose every 3~          months until disease progression.~        -  Between all doses of vaccine, patients may return home and travel back for the next~          visit. There is no requirement to stay locally in Bethesda at any point in the study~          outside of clinic visits and dosing days.~        -  Repeat imaging studies will be performed about 3 months after completion of radiatio...~   "
90432|NCT02383485|"~     Nonalcoholic fatty liver disease is a serious health condition in overweight children which~     can lead to heart disease. This project will examine the links between liver health and~     cardiovascular risk factors in overweight and obese children, and will test the effect of a~     long-term after-school exercise program.~      Provision of comprehensive evidence for the benefits of exercise on children's health may~     reduce barriers to vigorous physical activity programs during a childhood obesity epidemic.~   "
90524|NCT02382276|"~     The long-term safety and efficacy of nalmefene hydrochloride at 20 mg in patients with~     alcohol dependence will be evaluated in a multicenter, open-label, uncontrolled trial.~   "
90433|NCT02383472|"~     A double blind randomized trial of light-emitting diode (LED) therapy for patients suffering~     from mild traumatic brain injury (mTBI). Patients seen in the Sports Concussion Clinic with~     cognitive symptoms lasting for greater than 4 weeks will be randomized to either placebo~     therapy (controls) or treatment with LED therapy (cases). Both cases and controls would~     complete post-concussion symptom scales Delis-Kaplan Executive Function System (D-KEFS), and~     ImPACT studies on entry into the study and at weeks 3 and 6, or earlier if their symptoms~     resolve before the end of the 6 week period.~   "
90434|NCT02383459|"~     Food habits form early in infancy and are likely to track into childhood until the beginning~     of adulthood. Understanding the factors driving the acceptance of foods in the early years is~     therefore of particular importance, since these foods will form the basis of a child's future~     food repertoire. This is especially important for vegetables, which consumption is~     recommended at all stages of life but is below the recommended levels and which acceptance is~     difficult to promote during late childhood.~      The objective of the present study was to unravel the respective contribution of maternal~     feeding practices, of children's rate of exposure to vegetables and of children's sensory~     reactivity factors over the course of the first two years, to explain the development of~     liking for vegetables at the age of 2 years. This analysis took advantage of data recorded in~     a prospective cohort of children recruited before birth and followed up longitudinally until~     the age of 2 years.~   "
90435|NCT02383446|"~     Background:~      Trauma is the second most common factor for transtibial amputations, just after vascular~     background. Traumatic amputees generally function better than amputees due to vascular~     background. The type of prosthetic foot fitted to the patient depends on his mobility and~     functional level, and significantly influences his stability and gait symmetry. A prosthetic~     foot with a hydraulic ankle provides significant advantages for high level functioning~     amputees: decrease of loads in the residuum, improvement in symmetry and generally gait~     pattern that is closer to natural. The hydraulic prosthetic foot has recently been upgraded~     to include computerized control over the ankle movement, using input from an array of sensors~     inside the foot. Studies have demonstrated decrease in energy consumption and gait pattern~     that is more similar to healthy people. However, hydraulic feet with and without computer~     control have not been compared. Furthermore, the effects of a computerized foot on various~     important factors have not been investigated yet, e.g. loads in the residuum, the movement of~     the center of pressure and the patient's satisfaction.~      Research objectives:~      To compare between hydraulic prosthetic feet, with and without computerized control. The~     comparison will be made while walking on flat or inclined surfaces (positive or negative~     inclination). Differences in gait parameters, loads inside the residuum, center of mass~     movement and patient's satisfaction will be quantified.~      Research hypothesis: Using a computerized prosthetic foot will provide better mobility~     performances: improved gait factors and center of pressure movement, decrease internal loads~     in the residuum and increase patient's satisfaction.~      Research design:~      Clinical controlled research with research group(amputees) and control group (healthy).~   "
90436|NCT02383433|"~     This phase II trial studies how well regorafenib and gemcitabine hydrochloride work as~     second-line therapy (treatment given when initial treatment doesn't work) in treating~     patients with pancreatic cancer that has spread to other parts of the body. Regorafenib may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs~     used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the~     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Giving regorafenib together with gemcitabine hydrochloride may~     kill more tumor cells.~   "
90437|NCT02383420|"~     The purpose of this clinical study is to evaluate the imaging performance of the Carestream~     PRO 3543 Detector and Carestream PRO 3543C Detector (referred to as the investigational~     devices) as compared to the currently marketed Carestream DRX-1 Detector (referred to as the~     predicate device). Both detectors are flat panel digital imaging devices. The results of~     this study will be included in a Traditional 510(k) FDA Submission to obtain clearance to~     market the new detectors in the US. The study was designed in accordance with the FDA~     Guidance titled Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging~     Devices, issued on August 6, 1999.~   "
90438|NCT02383407|"~     The primary aim of the current proposal is to evaluate safety and tolerability, in terms of~     neuropsychological effects of low frequency electrical stimulation of the fornix (LFSF) in~     participants with medically-intractable Mesial Temporal Lobe Epilepsy. Secondary aims include~     evaluation of psychiatric changes, seizure frequency, and quality of life during LFSF.~   "
90439|NCT02383394|"~     Maternal and clinical characteristics associated with spontaneous second-trimester pregnancy~     loss (between 12 1/7 and 23 6/7 weeks of gestation) will be assessed.~   "
90440|NCT02383381|"~     •Background and study aims : The investigators conducted this study to evaluate the movement~     of extraocular muscle after strabismus surgery with non-invasive tool called AS-OCT.~        -  Who can participate? patients who underwent typical lateral rectus recession surgery for~          correcting intermittent exotropia~        -  What does the study involve? Volunteers will attend a clinic for four visits over six~          months. They will undergo AS-OCT at every visits during follow up period. AS-OCT is~          non-invasive test to evaluate operation site. The test only requires their cooperation~          when they undergo AS-OCT.~        -  What are the possible benefits and risks of participating? This is non-invasive test for~          your postoperative follow up. Therefore, there will be no risks about this test.~        -  Where is the study run from? Samsung Medical Center~        -  When is the study starting and how long is it expected to run for? From Feb 2014 to Dec~          2014~   "
90441|NCT02383368|"~     The purpose of this study is to evaluate the safety and tolerability of ASP4132 and to~     determine the maximum tolerated dose and recommended phase 2 dose of ASP4132. The study will~     also determine the pharmacokinetics (PK) of ASP4132 and evaluate the preliminary antitumor~     activity.~   "
90479|NCT02382861|"~     The NAVA, by its more physiological aspect and a better adaptation of the patient to the~     ventilator with a decrease of asynchronies patients-ventilators, could decrease the duration~     of weaning and so decrease the duration of invasive mechanical ventilation and the~     morbi-mortality. The objective of this study is to compare the neurally adjusted ventilatory~     assist versus the usual management of weaning from mechanical ventilation, in term of~     duration of weaning, at the patients in period of difficult weaning from the invasive~     mechanical ventilation.~   "
90480|NCT02382848|"~     This research is being done to find out how effective Prazosin is in the treatment of bulimic~     patients experiencing distressing nightmares using subjective and objective measures.~   "
90481|NCT02382835|"~     This study aims to determine whether subjects who underwent large-diameter metal-on-metal hip~     arthroplasty are more likely to have developed heart failure or other conditions as compared~     to subjects with conventional hip replacements.~      We plan to link the National Joint Registry for England, Wales and Northern Ireland to the~     National Heart Failure Audit and GP records.~   "
90442|NCT02383355|"~     Cardiovascular disease (CVD) has emerged as a leading cause of morbidity and mortality in~     HIVinfected individuals. The precise mechanisms underlying this increased cardiovascular risk~     remain to be elucidated. Platelet hyperreactivity and increased platelet-monocyte aggregation~     (PMA) are found in HIVinfectedpatients and may contribute to the excess cardiovascular risk~     as platelets play a key role in the onset and progression of atherosclerosis and in acute~     cardiovascular events. In addition, HIV-infected individuals frequently suffer from~     persistent immune activation and inflammation. In a crosssectional study the investigators~     recently showed that individuals using a regimen containing the integrase inhibitor~     raltegravir have reduced platelet hyperreactivity and PMA compared to other antiretroviral~     regimens. Other recent studies showed that raltegravir is associated with decreased immune~     activation. Due to the inherent limitations of cross sectional studies, the investigators aim~     to expand our findings in an intervention study. The investigators will conduct a randomized~     control trial where the investigators switch patients to a integrase containing treatment~     regimen to assay possible changes in platelet function and persistent immune activation.~     Knowledge gathered in the proposed study can help understand and prevent cardiovascular~     disease in patients treated for a HIV infection by reducing platelet hyperreactivity and~     persistent immune activation.~   "
90443|NCT02383342|"~     Pain is the most frequent cause of suffering and disability in society. Despite considerable~     involvement of genetic factors in pain sensation and sensitivity, the individual genes~     involved remain largely unidentified.~      Knowledge of genetic factors,their phenotypic expression in pain processing, and their link~     to neuronal correlates can improve our understanding of pain aetiology and the processes~     involved in pain perception and chronification. In addition, they can serve as biomarkers to~     predict chronic pain development and progression in individual patients and help early~     individual treatment adaptation.~   "
90444|NCT02383329|"~     The purpose of this study is to test whether the provision of ONS to malnourished children~     across Europe, in addition to standard counselling, will improve weight gain and other~     outcomes.~      The hypothesis to be tested is:~      • Supplementation with ONS in malnourished paediatric patients will lead to increased WFH~     gain, as well as less malnutrition related complications (e.g. infections).~      Primary outcome • The change in BMI z-score over the intervention period of 3 months~      Secondary outcomes~      • The change in WFH-weight for height (z-scores) over the intervention period of 3 months~   "
90445|NCT02383316|"~     Noonan syndrome (NS) is a rare genetic disease (incidence 1/2500 live births) characterized~     by the association of craniofacial manifestations, cardiopathies, short stature, and tumor~     predisposition. The genetic causes of Noonan Syndrome are mutations of genes involved in the~     Ras/Mitogen-Activated Protein Kinases (MAPK) pathway, mainly the gene encoding the tyrosine~     phosphatase Shp2 (50% of patients).Shp2 appears to be involved in many facets of energy~     metabolism control (glucose homeostasis, adipose tissue function…), through mechanisms that~     are poorly understood. Several metabolic anomalies (reduced adiposity, improved glucose~     tolerance) have been recently identified in an original mouse model carrying Shp2 mutation.~     Moreover, recent clinical survey has shown that adult Noonan Syndrome patients are protected~     from developping overweight and obesity when compared to the general population. However, the~     metabolic status associated with Noonan Syndrome condition has not been explored to date.~   "
90446|NCT02383303|"~     The U.S. Department of Health and Human Services, Administration for Children and Families~     (ACF) is conducting an experimental evaluation of the Assets for Independence (AFI) Program.~     This evaluation—the first experimental evaluation of Individual Development Account (IDA)~     projects operating under the Assets for Independence Act—will contribute importantly to~     understanding the effects of IDA projects and IDA project features on participants. IDA~     programs provide matching funds to participants when the savings are withdrawn to spend on~     qualified asset purchases, most commonly homeownership, business-related expenses, or~     education.~      This study will build on the prior quasi-experimental AFI evaluation, as well as studies of~     other non-AFI funded Individual Development Account (IDA) projects. While some evaluations~     suggest that IDAs help low-income families save, rigorous experimental research is limited.~     No experimental evaluation of AFI-funded programs has been conducted to date. Of the quasi-~     or non-experimental studies, few have focused on AFI-funded IDAs.~      The evaluation is being conducted in two sites, with the random assignment of 299~     AFI-eligible cases in one site and 509 cases in the other, for a total of 808 cases. Each~     site randomly assigned sample members to one of two groups: a control group and a treatment~     group receiving conventional AFI services. The primary research questions the study seeks to~     answer are:~        1. What are the impacts of AFI program participation on the outcomes it is designed to~          address (e.g., savings and asset purchases)?~        2. What are the impacts of AFI program participation on other outcome domains that the~          program might influence (e.g., material hardship, alternative financial product use,~          economic well-being)?~        3. How do the impacts of AFI program participation vary over time and by participant~          characteristics?~      The study uses a two-armed (treatment vs. control) experimental design. This design allows~     the first two questions above to be addressed using a rigorous randomized approach.~      In addition to the impact study, the evaluation includes an implementation study to describe~     and document how the AFI program is designed, implemented and operated in the participating~     grantee sites during the time of the study. This information will be used to provide context~     for interpreting the findings of the impact study.~   "
90447|NCT02383290|"~     Certain parts of the gene can predict how an individual person will respond to medication~     (pharmacogenetics). We will invite 250 individuals to give a sample of saliva. This sample~     will be sent to a laboratory for limited genomic analysis relating to pharmacogenetics. When~     personal data held by the participants, family physician, or pharmacist is joined with the~     genetic data personalized prescription recommendations are formed. The family~     physicians/pharmacists can view these recommendations through their electronic record. This~     should result in prescriptions that may be more beneficial and cause fewer adverse events.~   "
90448|NCT02383277|"~     Investigate the effects of stretching the muscles of the rib cage in individuals with COPD~     during exercise.~   "
90482|NCT02382822|"~     Despite efficient antiretroviral treatment for HIV infection, decrease in life expectancy~     remains. Excess mortality is mainly due to non-AIDS co-morbidity including cardiovascular,~     pulmonary, and liver related diseases. Both HIV-unrelated and HIV-related risk factors~     probably contribute to this pattern. At present, most evidence regarding co-morbidity in HIV~     infection rely on cross-study comparisons of HIV-infected persons with published population~     rates and few prospective studies in U.S. cohorts. Using well characterized participants from~     the Copenhagen General Population Study (CGPS) as controls, we aim to include >1500~     HIV-infected persons in the COCOMO study to determine if co-morbidity is more prevalent or~     develops at a higher rate in HIV-infected persons. The study will asses 1) cardiovascular, 2)~     pulmonary and 3) liver-related co-morbidity using uniformly collected data in the two~     cohorts. The investigators aim to study the relative impact of HIV-unrelated and HIV-related~     factors on development of co-morbidity.~   "
90483|NCT02382809|"~     The purpose of this study is to demonstrate the efficacy of 0.2 % digluconate chlorhexidine~     mouthwash in the prevention of alveolar osteitis following third molar extraction and to~     evaluate the safety and local tolerability.~   "
90449|NCT02383264|"~     Enteral nutrition of preterm and intrauterine growth-restricted (IUGR) infants is still a~     challenge for neonatologists. Due to the immaturity of the gastrointestinal tract, preterm~     infants are at high risk of developing feeding intolerance (FI) or necrotizing enterocolitis~     (NEC), which is the most feared gastrointestinal complication of prematurity. The occurrence~     of FI often prompts clinicians to withhold, decrease or discontinue enteral feeds; thus, the~     establishment of an adequate early enteral nutrition is frequently hampered. Early~     identification of preterm infants at high risk for gastrointestinal complications could help~     clinical decisions on the introduction and the advancement of enteral feeding.~      Near-infrared spectroscopy (NIRS) provides a non-invasive monitoring of regional oxygen~     saturation (rSO2). A significant correlation between lower abdominal rSO2 values in the first~     week of life and subsequent NEC development has been reported. To date, however, splanchnic~     oxygenation patterns in response to the first bolus feed and possible correlations with~     subsequent FI development have not been yet established.~      This observational prospective study aims:~        -  to assess abdominal rSO2 patterns in response to the first bolus feed;~        -  to evaluate possible correlations with subsequent development of gastrointestinal~          complications.~   "
90450|NCT02383251|"~     Study of Pazopanib and weekly Paclitaxel in patients with platinum resistant/refractory~     ovarian cancer who relapse during bevacizumab maintenance.~   "
90451|NCT02383238|"~     Dapagliflozin leads to improved vascular function in the micro- and macrocirculation by~     action on various cardiovascular risk factors, in particular by effectively controlling~     hyperglycemia, arterial hypertension and reducing whole sodium content amongst others.~   "
90452|NCT02383225|"~     This study involves adaptation, implementation, and rigorous evaluation of a family-based~     program designed to prevent early initiation of substance use on a Northern Plains Indian~     reservation. The program, Thiwáhe Gluwáš'akapi, is a cultural adaptation of the Iowa~     Strengthening Families Program for Parents and Youth 10-14. Youth and their~     parents/caregivers will participate in weekly group sessions for 7 weeks and complete pre-~     and post-intervention surveys assessing a variety of risk and protective factors and youth~     outcomes. The evaluation design will allow the assessment of the effectiveness of different~     components within the program.~   "
90453|NCT02383212|"~     This is a phase 1, open-label, multicenter, ascending-dose escalation study of REGN2810,~     alone and in combination with other anti-cancer therapies in patients with advanced~     malignancies.~   "
90454|NCT02383199|"~     The purpose of this study was to report the long-term objective and subjective outcome after~     prolapse surgery with polypropylene mesh. The complications and the effect of the learning~     curve of the surgeons to the outcome is also reported.~   "
90455|NCT02383186|"~     The purpose of this study is to determine whether a single layer dermally sutured wound~     results in superior outcomes to a layered closure.~   "
90456|NCT02383173|"~     The overarching goal of this research program is to improve the quality of end-of-life care~     provided to Veterans dying in VA Medical Centers, by transferring the best practices of home~     hospice and palliative care for the last days and hours of life into the inpatient setting.~     This trial will examine two methods of delivering a Comfort Care Education Intervention~     utilizing the established infrastructure of VA Palliative Care Consult Teams (PCCT): a Basic~     Implementation Approach using a teleconference to review educational materials and activate~     PCCTs to educate other providers, and an Enhanced Implementation Approach utilizing~     in-person, train-the-champion workshops to prepare PCCT members to be leaders and trainers~     at their home sites. Findings will provide a robust evaluation of the implementation process,~     and will be used to refine the Comfort Care Education Intervention and implementation~     strategies in preparation for nationwide dissemination of best practices for end-of-life care~     within the VA Healthcare System.~   "
90457|NCT02383160|"~     This is a prospective, double-blind, randomized controlled trial to determine the~     effectiveness of low-intensity pulsed ultrasound in decreasing the time to union of scaphoid~     non-unions after operative fixation as measured by serial CT scanning. Multiple centers~     within the Calgary zone will be involved in the study in order to recruit enough patients to~     power the study. Blinding will include patients, surgeons, research assistants, as well as~     all data handlers and analysts until trial completion or mid-term analysis.~   "
90458|NCT02383147|"~     Chronic tinnitus affects about 10-15% of the population in industrialized countries.~     Investigations of the brain activity by using electroencephalography (EEG) showed that in~     localized regions of the hearing system brain activity was decreased. This reduction of~     activity is thought to be one of the reasons that keep the perception of the tinnitus going.~     Recent studies have shown that neurofeedback is a viable option for treatment of chronic~     tinnitus. By using neurofeedback it is possible to train brain functions by the simple~     principle of rewarding wanted changes and punishing unwanted ones. The purpose of the~     investigators study is to show the efficacy of specific localized neurofeedback training in~     comparison to global relaxing neurofeedback training. In order to achieve decreased tinnitus~     symptoms or even disappearance of the tinnitus, 15 neurofeedback trainings are planned.~     Before and up to 6 month after the training EEG-recordings are performed.~   "
90459|NCT02383134|"~     The achievement of peripheral nerve block requires several needle passes, with each of them~     being at risk of causing nerve injury either by direct trauma or intraneural injection even~     with the use of the ultrasound.~      The ultrasound guided supraclavicular brachial plexus block is known to be at risk of~     pneumothorax and / or nerve injury.~      This study is designed to determine the maximal effective distance away from the nerve for~     the injection to be effective.~   "
90484|NCT02382796|"~     The purpose of this study to permit continued access to dacomitinib for patients who~     participated in other dacomitinib monotherapy treatment protocols in Japan and have the~     potential to derive clinical benefit without unacceptable toxicity from continued dacomitinib~     treatment.~   "
90485|NCT02382783|"~     The purpose of this study is to determine how best to monitor for flares in patients with~     rheumatoid arthritis (RA).~   "
90486|NCT02382770|"~     To evaluate the different indications to Open Abdomen, the different techniques used to~     perform it, it's management, it's definitive closure and mortality rates linked to the~     different variables. Moreover to evaluate the 1 month and 1 year follow up in patients~     underwent to Open Abdomen.~   "
90460|NCT02383121|"~     Acute ischemic stroke (AIS) affects over 700,000 Americans every year and is the leading~     cause of long-term disability. Early neurological deterioration after AIS typically occurs~     within 72 hours of stroke onset and affects 30% of all stroke patients, who have a higher~     rate of death or poor outcome. Several mechanisms account for early neurological~     deterioration, including hemorrhagic conversion, systemic illness, cerebral edema, and~     seizure, but the most common cause is extension of the stroke into the penumbra, a region~     of salvageable brain tissue surrounding the core of irreversible ischemic infarct. The~     penumbra is tenuously perfused by collateral blood vessels. AIS management is primarily~     focused on recanalizing the occluded artery causing the stroke, but an alternative and~     relatively unexplored approach is optimization of collateral blood flow.~      Over 60% of AIS patients present with a transient acute hypertensive response, which is~     theorized to be the result of either increased sympathoadrenal tone, poorly controlled~     underlying hypertension, or an unknown stroke-specific mechanism related to augmenting~     cerebral perfusion through collateral blood flow. Epidemiological data suggests worse stroke~     outcomes are associated with extremes of sustained hypo- or hypertension, which has led to~     dozens of clinical trials involving over 20,000 patients to determine if pharmacologically~     lowering blood pressure after AIS is beneficial. The results have been persistently neutral~     or negative. In contrast, there have been no major clinical trials on the efficacy of using~     vasopressor medications to maintain or increase baseline blood pressure after AIS, despite~     promising preclinical data and pilot studies that showed no increase in cerebral hemorrhage~     or edema. The only randomized trial of vasopressor use after AIS demonstrated an improvement~     in clinical outcomes, but there was no difference in mean blood pressure between the control~     and intervention arms, suggesting the beneficial effect was not exclusively related to~     induced hypertension. One possibility is that the vasopressor reduced blood pressure~     variability, which preliminary data has shown to be detrimental after AIS, although that~     aspect of neurovascular coupling has not been adequately studied in the acute phase after~     AIS.~      The reliance on IV vasopressors, which are only administered in the intensive care unit, is a~     fundamental limitation of prior research. An alternative, but untested, approach is to use~     the oral vasopressor midodrine hydrochloride. We hypothesize that frequent midodrine dosing~     after AIS can optimize collateral blood flow and help salvage the ischemic penumbra. The~     objective of this study is to develop tools to quantify midodrine's effect on blood pressure~     and the ischemic penumbra.~   "
90461|NCT02383108|"~     A two-arm, Phase 2/3 multicentre, open-label, randomised study evaluating safety and~     antiviral effect of current standard antiretroviral therapy compared to once daily integrase~     inhibitor administered with darunavir/ritonavir (DRV/r) in HIV-1 infected, virologically~     suppressed paediatric participants.~   "
90462|NCT02383095|"~     The main purpose of the protocol is to test the efficiency of art-therapy versus~     metacognitive rehabilitation on the visual perception disorders observed in patients with~     schizophrenia.~   "
90463|NCT02383069|"~     Asthma is one of the main chronic diseases in childhood and it is characterized by the~     inflammation of airways. Individuals with chronic lung disease are more susceptible to~     present reduction in exercise tolerance due to pulmonary limitations. The pulmonary~     rehabilitation may improve the physical capacity in asthmatic patients, as observed in other~     chronic lung diseases.~   "
90464|NCT02383056|"~     The goal of the study is to evaluate the effectiveness of the light-emitting diode (LED) in~     promoting healing of the wound on lower leg as a result of surgery. Wounds on the lower leg~     heal more slowly than wounds on the head and neck; they can also remain deep red for six~     months to one year. Doctors usually allow a lower leg surgical wound to heal by itself,~     without stitches or other additional treatment. This is because leg wounds do not hold~     stitches well and stitches could cause other problems. A major drawback of allowing a~     surgical wound on the lower leg to heal by itself is the long healing time that can often~     take months. The investigators wish to evaluate if the LED light treatment of the surgical~     wound will improve the healing of your wound.~      In order to test if leg wounds heal faster after treatment with LED, half of the patients in~     the study will receive the LED (Group 2) and half will not receive treatment with LED but~     will receive a sham light treatment (Group 1). Essentially, a sham light treatment refers~     to regular light (not LED) exposure for 20 minutes. The sham light comes from the same device~     as the treatment light (Omnilux machine) however, this light has no anticipated effects on~     wound healing and is used simply to reduce the amount of bias that sometimes complicates the~     results of these studies. There is no added risk or benefit for the patients in the control~     group exposed to the sham light. Both groups will receive the standard care of wounds on the~     lower extremity.~   "
90465|NCT02383043|"~     Cocaine-use disorders continue to be a significant public health concern, yet no effective~     medications have been identified. The goal of this study is to establish a research platform~     for the development of medications for treatment of cocaine abuse and dependence. This study~     will incorporate choice self-administration procedures between drug and a non-drug~     alternative reinforcer presented during maintenance on d-amphetamine, which has been~     previously shown to reduce cocaine use.~   "
90466|NCT02383030|"~     Breast cancer is one of the most prevalent cancers among women, and represents 20 - 25% of~     all female cancers. Despite earlier diagnosis and improvement in adjuvant therapies, some~     patients will present metastatic recurrence.~      Treatment of breast cancer is determined by the extent of the disease. Early or localized~     breast cancer is treated by a combination of surgery and radiotherapy. Adjuvant systemic~     therapy, consisting of chemotherapy and/or endocrine therapy, in tumors deemed hormone~     responsive, can prolong the disease-free interval and improve overall survival. However,~     approximately 30% to 40% of patients with early breast cancer will ultimately relapse, with~     either local recurrence or distant metastases, and require further systemic treatment for~     advanced disease.~      Since breast cancer that recurs or progresses after initial treatment is considered~     incurable, the therapy options available for advanced disease are concerned with disease~     control and palliation of symptoms.~      Hormonal therapy has become the treatment of choice in postmenopausal women with hormone~     sensitive breast cancer. Even though the treatment of advanced breast cancer in~     postmenopausal women has improved with the introduction of agents such as aromatase~     inhibitors, these agents still have limitations, and disease management continues to be~     sub-optimal. The use of systemic therapies such as hormonal therapy, chemotherapy or new~     biological treatment is to reduce tumour masses, improve survival and preserve quality of~     life. Whatever the initial efficacy of the treatment undertaken in metastatic setting, almost~     every patient will relapse. The main goal is to improve progression free survival (PFS). To~     achieve this, the type of chemotherapy, the optimal duration of chemotherapy, the benefit of~     maintenance chemotherapy, the benefit of maintenance hormonal treatment are debatable.~   "
90467|NCT02383017|"~     This study will examine how the supplement Shroom Tech Sport (STS) affects body composition~     and different performance and health measures over the course of 12 weeks. The supplement~     will be combined with a concurrent training regime consisting of resistance and high~     intensity interval training. Subjects will be tested for percent body fat to determine body~     composition. Further, they will also be tested for maximal strength (squat and bench),~     maximal power output and fatigue, lactate threshold and maximal oxygen volume consumption~     (VO2max). And finally, subjects will be tested for health and hormone markers in the blood.~     All of these measures will be compared against a placebo group participating in the same~     exercise intervention.~   "
90487|NCT02382757|"~     This study is conducted in Asia. The primary objective of the CDiC programme is to improve~     access to comprehensive diabetes care among the children with diabetes from the economically~     underprivileged section of the population and to establish a registry for this group of~     children with type 1 diabetes in India.~   "
90468|NCT02383004|"~     Myringotomy tube placement is one of the most commonly performed operations in children.~     Emergence delirium after such procedures is common. During emergence delirium children can~     become both a danger to themselves and others around them, including family members and~     hospital staff.~      The primary objective of this study is to determine if acupuncture, when used in combination~     with standard anesthetic management, decreases the incidence of emergence delirium in~     pediatric patients following myringotomy tube placement. Patients with and without~     premedication of midazolam will be included. A secondary objective of this study is to~     determine our institution's actual incidence of emergence delirium for this operation using a~     validated scale, the Pediatric Anesthesia Emergence Delirium (PAED) scale. We will also~     compare rates of emergence delirium in patients that received a premedication of midazolam~     versus (V) those that did not (NV).~      This is a randomized double-blinded trial. We will enroll 100 children aged 1-6 years old.~     Premedication with midazolam will be decided by the anesthesiologist. If needed, the patient~     will receive a standard does of oral midazolam plus acetaminophen (V). If the patient does~     not require premedication with midazolam, oral acetaminophen will be given alone (NV).~      Patients will then be randomized to receive either acupuncture with standard general~     anesthesia care (A) or to receive standard anesthetic care alone (S). Patients, their family~     members and recovery registered nurses (RNs) will not know if acupuncture was performed.~     Intraoperative anesthetic techniques will be standardized and include inhaled inductions with~     nitrous oxide and sevoflurane. Anesthesia maintenance will be inhaled sevoflurane and the~     usual pain medication ketorolac will be given intramuscularly prior to emergence. Acupuncture~     needles will be placed after anesthesia induction and removed prior to leaving the operating~     room. A total of 4 needles will be placed, one in each wrist at the Heart 7 (HT7) point and~     one in each ear at the Shen Men point. The needles will be inserted bilaterally to a depth of~     1.8 mm.~      In the PACU, a blinded study observer will evaluate the patient at four time points using the~     PAED scale: time of awakening and 5, 10 & 15 minutes after awakening. Follow up phone calls~     will be made one day and one week after surgery. Families will be asked about behavior after~     discharge, sleep and bed-wetting.~   "
90469|NCT02382991|"~     Moderately active amputees may have lost their limb due to diabetes, vascular conditions,~     trauma, tumour or congenital causes. These amputees currently cannot benefit from having a~     computerised knee because of the performance criteria associated with being given one.~     However, these amputees have a very high risk of falling because they use a non~     microprocessor controlled knee joint (NMPK) and because their physical ability, associated~     disability and persistent contralateral leg weakness do not allow them to compensate for a~     balance deficit. These amputees restrict how much they move around and their participation~     because of their instability and elevated risk of falling.~      The objective of the study is to evaluate the effect of the 3C60 knee, a~     microprocessor-controlled knee joint for external leg prosthesis, on the reduction in the~     risk of falling after three months in moderately active persons with leg amputation above~     knee or knee disarticulation.~   "
90470|NCT02382978|"~     This study will test whether or not nurses can provide well child care in a~     multi-disciplinary primary health care team without physicians also seeing the children at~     pre-scheduled well child care visits.~   "
90471|NCT02382965|"~     It is the purpose of this proposal to apply tFUS to the ventral posterior lateral (VPL)~     nucleus of the thalamus in humans.~   "
90472|NCT02382952|"~     The primary purpose of this study is to evaluate the quality of blunt dissection during~     abdominal and pelvic surgery involving dissection of adhesions, separation of blood vessels~     and neurovascular structures while preserving the integrity of these structures.~   "
90473|NCT02382939|"~     This trial is conducted in Europe and Asia. The aim of the trial is to compare the safety of~     once weekly dosing of somapacitan (administered with an investigational pen) with daily~     Norditropin® FlexPro® (somatropin delivered within a prefilled pen) for 26 weeks in~     previously human growth hormone (hGH) treated adults with growth hormone deficiency.~   "
90474|NCT02382926|"~     In this trial contactless heart rate, electrocardiography and breathing rate measurements are~     elevated during car simulation in cardiac rehabilitation via automotive sensors and camera.~   "
90475|NCT02382913|"~     The purpose of this study is to evaluate the persistence of immune response against the three~     pertussis antigens (anti- pertussis toxoid (PT), anti-filamentous hemagglutinin (FHA) and~     anti-pertactin (PRN)) in subjects who received a booster dose of either aP or Tdap study~     vaccines or Boostrix® during V113_01 study.~      There was only one Clinic Visit at day 1. Eligible subjects went undergo a single blood draw~     after which they were observed for approximately 15 minutes. Approximately 10.0 mL of blood~     was withdrawn.~      No vaccine was administered and no safety data was collected in this study.~   "
90476|NCT02382900|"~     In the genital tract human papilloma virus (HPV), especially types 6 and 11 cause genital~     warts, the commonest viral sexually transmitted disease. The HPV 16 and 18 are the most~     common oncogenic high-risk genotypes and cause approximately 70% of all cervical cancers~     despite the fact that are associated with other anogenital cancers, anus, vagina, vulva and~     penis, and cancers of the head and neck. Current estimates are that 5.2% of all cancers are~     HPV associated. A large number of studies, including both adult and young females, have~     demonstrated that HPV vaccines are highly immunogenic and induce a long lasting protection~     against infection. Immunogenic vaccination results in young men and boys are equally~     satisfactory with the quadrivalent HPV (types 6, 11, 16, 18) vaccine recommended for men. The~     recommended vaccination scheme includes three shots giving the second at two months and the~     third at six months after the initial shot. Recently, it has been shown that the use of a two~     shot scheme (0 and 6 months) is equally effective among girls. The purpose of this study is~     to determine that the immunogenicity is non-inferior in boys using a two shot scheme compared~     with young women and girls.~   "
90477|NCT02382887|"~     Patients who present with an unstable cervical spine following an accident need a general~     anesthesia for the necessary surgery.~      Commonly, the management of the tracheal intubation is performed by a fiberoptic technique.~      However, changes in equipment availability and quality may challenge the fiberoptic~     intubation technique.~      The investigators wish to compare the tracheal intubations performed with the Airtraq in~     comparison with the fiberscopic technique.~   "
90478|NCT02382874|"~     Idiopathic Focal Segmental Glumero Sclerosis (FSGS) is not very common but important~     manifestation of kidney disease.~      FSGS has poor prognosis among the patterns of Idiopathic Nephrotic Syndrome (INS).~      Even with treatment (Steroid therapy and cytotoxic immunosuppressant therapy), many patients~     eventually still require dialysis.~      Cell therapy is useful in treatment of INS and mesenchymal stromal/stem cell is one of the~     cells that useful in the treatment of glomerulus disease.~      Intravenous injection of allogeneic adipose derived mesenchymal stromal/stem cell will be~     done in 5 patients with refractory INS(FSGS). They will be followed 1, 2, 4 weeks and then~     monthly until a year following injection day.~   "
90670|NCT02380352|"~     Randomized controlled double-blind non-inferiority clinical trial to determine whether five~     days of high-dose amoxicillin leads to comparable rates of early clinical cure compared with~     10 days of high-dose amoxicillin for previously healthy children with mild community-acquired~     pneumonia.~   "
90489|NCT02382731|"~     Proven treatments exist that improve quality of life and reduce the risk of repeat heart~     attacks or death amongst persons who have already had one heart attack. These treatments~     include medications and supervised cardiac rehabilitation programs. Unfortunately, research~     shows that many people who have had a heart attack do not stick with these treatments and~     therefore cannot benefit. This quality improvement research program seeks to understand the~     impact of interventions that could be readily implemented at scale by entire health systems~     or organizations wishing to improve adherence to proven treatments. Specifically, the trial~     will test whether providing Ontario-based patients (and their health professionals) with~     repeated educational reminders delivered via post and phone will help improve the use of~     medications or attendance at cardiac rehabilitation. During the project, the types of~     patients who are most responsive will be identified as will the most cost-effective strategy~     for delivering reminders. The trial team are partnering in this project with health system~     decision makers who have an interest in using the results to create standard operating~     procedures that could benefit patients across the province.~   "
90490|NCT02382718|"~     This is a phase IIb clinical trial to investigate the efficacy and safety of subcutaneous~     immunotherapy with a modified parvalbumin called mCyp c 1 for the treatment of fish allergy~     to subjects allergic to fish.~   "
90491|NCT02382705|"~     Capsule endoscopy (CE) is a non-invasive means of visualizing the small bowel. Common~     indications for CE include obscure gastrointestinal (GI) bleeding, inflammatory bowel disease~     like crohn's disease or ulcerative colitis, celiac disease, and polyposis syndrome.~      While CE has high diagnostic value for small bowel lesions, a significant limitation of this~     technology is the finite battery life which results in incomplete examination of the small~     bowel approximately 16.5% of the time. Numerous attempts of using pharmacological (e.g.~     prokinetics, purgatives) as well as non-pharmacological measures (e.g. real-time viewer,~     chewing gum) to improve completion rates, defined by entry of CE into the cecum, led to mixed~     results. Currently routine use of prokinetics (agents that speeds up gut motility) is not~     recommended.~      This study aims to determine whether longer battery of the newer generation capsule endoscopy~     system improves study completion rate and diagnostic yield.~   "
90492|NCT02382692|"~     Sinus surgery is a common procedure. A potential complication is injuring the membranes of~     the brain. This can lead to leakage of brain fluid through the nose. We would like to~     estimate the incident rates of that complication. At the end of the operation, a thin gauze~     is inserted into the nose on both sides in addition to the usual tampon. This gauze will be~     analyzed at the laboratory for beta-2-transferrin, which is a biomarker for brain liquid.~   "
90493|NCT02382679|"~     The purpose of this study is to assess the efficacy of vitamin therapy in concussion when~     compared to placebo with respect to multiple endpoints including symptom severity, cognitive~     performance on computer based neuropsychological testing, post-concussion balance assessment,~     and post-concussion vestibular-oculomotor function.~   "
90494|NCT02382666|"~     The purpose of this study is to assess the safety and tolerability of single increasing doses~     of intravenously administered rolapitant in healthy male and female subjects.~   "
90495|NCT02382653|"~     100 patients with Breakthrough pain will be allocated to receive either oral prioxicam (OP)~     (n=50) or sublingual fentanyl (SLF) (n=50) . Patients will be divided randomly into two equal~     groups: oral prioxicam (OP) Group and sublingual fentanyl citrate (SLF) Group, comprising of~     50 patients each.~      Pain intensity level on a 0-10 visual analog scale (VAS), patients will be instructed about~     the use of a 10-cm visual analog scale (VAS) (0 = no pain to 10 = worst possible pain).~     frequency of Breakthrough pain throughout the day, onset of relief (0-5, 6-10, 11-15, or over~     16 min), time required for dose titration, patient satisfaction and adverse effects were~     assessed at 3, 7, 15, and 30 days after starting the treatment.~   "
90496|NCT02382640|"~     The purpose of this study is to assess the effect of antacid administration, and its timing,~     on the bioavailability of a single dose of febuxostat extended-release (XR) 80 mg.~   "
90497|NCT02382627|"~     This study plans to learn more about the thickness of the choroid in patients with optic~     neuropathy. The choroid is a layer of blood vessels that supplies oxygen and nourishment to~     the outer layers of the retina. Patients are being asked to be in this research study because~     they have optic neuropathy and are receiving care at the University of Colorado Hospital.~   "
90498|NCT02382614|"~     VAST is a multicenter, prospective, randomized, controlled study designed to evaluate~     treatment of persistent air leak with the SVS as compared to standard chest tube drainage~     management and other standard-of-care interventions in the control group. Eligible subjects~     will be randomized to receive either Spiration Valves (investigational arm) or continue~     standard-of-care treatment (control arm). Once the air leak has resolved, Spiration Valves~     should be removed.~   "
90499|NCT02382601|"~     The investigation will employ a longitudinal approach in which every fetus diagnosed to be~     SGA (Small for Gestational Age ) will be studied at frequent intervals with sophisticated~     imaging techniques to assess subtle physiologic changes in the brain, heart, and placenta~     over time. These findings will be correlated with neurological and cardiovascular function in~     the newborn and early childhood. This research initiative should yield diagnostic and~     therapeutic templates that will improve the quality of life of IUGR babies in addition to~     providing important information that will better inform current diagnostic practices.~   "
90500|NCT02382588|"~     The purpose of this study is to evaluate the efficiency of topical gancyclovir 0.15% in the~     treatment of herpes zoster keratitis. Half the patients will receive the study drug while the~     other half of the patients will receive the placebo~   "
90535|NCT02382133|"~     Continuous pulse oximetry monitoring is the standard of care in critically ill patients in~     emergency departments, operating rooms and intensive care units. In patients with poor~     peripheral perfusion (low blood flow) due to peripheral vascular disease, low body~     temperature, or shock and the use of medications to raise the blood pressure, clinicians have~     difficulty obtaining an accurate measurement. This study compares the accuracy of forehead~     oximetry sensors to nasal alar sensors to lab oximetry measures and on the rate of device~     related pressure ulcers with both.~   "
90684|NCT02380170|"~     The study aims to get an insight on the causative bacteria of sepsis derived from the urinary~     tract. Furthermore, it is the intention to understand the outcomes of these patients. For~     this purpose a non-interventional, observational study will be conducted.~   "
90501|NCT02382575|"~     The vast majority of children with idiopathic nephrotic syndrome respond well to~     corticosteroid treatment. However, as many as 20% experience a more complicated course with~     steroid resistance (SRNS). Repeated and prolonged courses of steroids in these children often~     result in long-term complications. The goal of treatment is to reduce the rate of relapses,~     the cumulative dose of corticosteroids, and the incidence of serious complications. In order~     to minimize the side effects of steroid therapy, different steroid sparing agents such as~     cyclophosphamide, calcineurin inhibitors(CNI), levamisole, and mycophenolate mofetil (MMF)~     have been used in SRNS. Whereas CNI are usually considered the steroid sparing drug class of~     first choice, rituximab is increasingly used as alternative to minimize CNI toxicity. Various~     prospective studies suggest that Rituximab, a B cell depleting monoclonal antibody, could be~     a safe and effective alternative to steroid or immunosuppressants to achieve and maintain~     remission in this population. Rituximab infusion have been shown to be efficacious for 6 to~     12 months and the side effect profile observed to date is very benign. Studies comparing the~     usefulness of these agents are lacking. In this proposed randomized controlled trial, the~     investigators want to compare the efficacy and safety of CNI to that of Rituximab in treating~     children with SRNS.~   "
90502|NCT02382562|"~     Depression and other unhealthy behaviors, such as not taking medication as prescribed and not~     attending doctor visits have been suggested to increase the worsening of allergic diseases~     (e.g. asthma, urticaria). We intend to determine whether a one-session behavioral~     intervention is effective in helping with depression and controlling disease symptoms. We~     will measure this using pre- and post-intervention surveys.~   "
90503|NCT02382549|"~     This study evaluates whether it is safe to administer a helper peptide vaccine with~     dabrafenib and trametinib. This study will also evaluate the effects of the combination of~     the peptide vaccine and dabrafenib and trametinib on the immune system. We will monitor these~     effects by performing tests in the laboratory on participants' blood, a lymph node, and tumor~     samples.~   "
90504|NCT02382536|"~     The purpose of this study is to compare the in-line fluid pressure (pressure of the fluid~     going through the tubing) and leakage (observation of fluid on and around the device) during~     and after subcutaneous infusion using two types of infusion sets. One infusion set is~     investigational, developed by BD, and the other is the Quick-set (Medtronic), which is~     commercially available. These infusion sets will be used with a commercially available~     insulin pump to deliver insulin diluent (an inactive liquid with no medication) for~     approximately 4 1/2 hours. During this time pressure and leakage will be continuously~     monitored.~   "
90505|NCT02382523|"~     IgA nephropathy occurs when IgA—a protein that helps the body fight infections—settles in the~     kidneys. IgA deposits may cause the kidneys to leak blood and sometimes protein in the urine.~     Proteinuria (abnormal amounts of protein in urine) can be a sign of kidney damage. Current~     treatments for IgA nephropathy is limited to Angiotensin Converting Enzyme (ACE) inhibitor~     medications with fish oil. ACE Inhibitors, also called ACEI medications, slows the~     angiotensin converting enzyme so that blood vessels can be relaxed.~      This study involves the study drugs, Acthar and Lisinopril (an ACEI medication routinely~     given for high blood pressure).~      In previous clinical studies, some subjects with IgA nephropathy have experienced reductions~     in proteinuria with consistent use of Acthar. Acthar is approved by the Food and Drug~     Administration (FDA) and used to treat patients with proteinuria.~      The purpose is to study the safety and effectiveness of the study drug Acthar given at~     different doses.~   "
90506|NCT02382510|"~     This multiple ascending dose study is to determine the safety and bronchodilator activity of~     TRN-157 in 59 mild and moderate asthmatics.~   "
90507|NCT02382497|"~     The present study grounds on the possible role of hemispheric lateralization in Eating~     disorders (ED): specifically, hyperactivity of the right frontal regions in Anorexia Nervosa~     (AN), and hypoactivity of the right frontal regions in Binge Eating Disorder (BED) and food~     craving behaviors.~      Therefore, the investigators hypothesized that active excitatory tDCS over left prefrontal~     cortex (PFC) (Anode left/cathode right) may aid in altering/resetting inter-hemispheric~     balance in AN patients, re-establish control over eating behaviors. On the contrary, active~     excitatory tDCS over right PFC (Anode right/cathode left) may aid in altering/resetting~     inter-hemispheric balance in BED patients and people with frequent food cravings, decreasing~     cravings/appetite binge eating behaviors.~   "
90508|NCT02382484|"~     The purpose of this study is to test whether the A-V sequential pacing strategy shown to~     effectively reduce blood pressure in a dog model of hypertension also reduces blood pressure~     acutely in patients with hypertension (systolic blood pressure greater than 140 mmHg) despite~     medical treatments.~   "
90509|NCT02382471|"~     The aim of this study is the comparison between the effects of supplementation with omega 3~     or placebo for 8 weeks in serum level of BDNF، Follistatin، Irisin in patients with~     cardiovascular disease.~   "
90510|NCT02382458|"~     Diet plays a central role in the regulation of chronic inflammation. However, until the~     investigators developed the dietary inflammatory index (DII) there had been no scientifically~     valid way to relate what individuals eat to the capacity of foods consumed to modulate~     inflammation. The DII provides a tool that will form the basis of a counseling/instructional~     system aimed at helping patients and their providers to control chronic, systemic~     inflammation by improving the diet with specific, actionable dietary recommendations,~     counseling, and expert instruction. The goal of this study is to test the applicability of a~     DII mobile tool and associated counseling measures in clinical practice.~   "
90536|NCT02382120|"~     Cardiac output monitoring is mandatory in most surgical and critical care patients. Many~     techniques to assess cardiac output are invasive and/or have many limitations,~     contraindications and drawbacks. The measurement of cardiac output throughout the CO2 signal~     is an interesting option due to the simplicity and non-invasive nature of its calculation.~      The present study was designed to compare the cardiac output measurement using a capnodynamic~     formula versus the reference thermodilution method.~   "
90610|NCT02381158|"~     This is a single-centre, open label study, aiming to evaluate the efficacy of beclomethasone~     dipropionate applied for 12 weeks with a dose of 400 µg twice a day (total dose 800 µg~     nebulized), on airway resistance and reactances (measured with Rint and FOT techniques) in~     children with recurrent wheezing, aged 2-5 years. In addition, clinic score as frequency of~     symptoms and exacerbations, will be assessed.~   "
90511|NCT02382445|"~     Anesthetics and anesthesia are suspicious to induce dementia or aggravate preexistent~     cognitive deficits with or without evoking postoperative delirium. In animal trials various~     anesthetics induce increased levels of misfolded amyloid beta and protein tau, the molecular~     substance of pathophysiologic brain tissues of demented patients. The amount of those markers~     seems to correlate well with the degree of dementia [1]. In contradiction, a single study~     indicates that the incidence of postoperative cognitive deficit (POCD) decreases if hypnotic~     depth is deep [2]. Unfortunately the study did not sum up the amount of anesthetic drug load,~     since this would have clarified if the amount of anesthetics used is associated to POCD and~     dementia. Another possibility is that stress and noxious stimulation induced by light~     anesthesia results in POCD, whereas deep anesthesia protects from it or inhibits implicit~     memory.~      The investigators' prospective randomized trial is underway to verify the impact of~     anesthetics and narcotic depth upon grade of dementia and incidence of early postoperative~     cognitive dysfunction on postoperative day 1 as well as the incidence of delirium within a 90~     day period.~      The investigators' hypothesis is that the incidence of POCD and delirium and the degree of~     early cognitive dysfunction is less when anesthetic and vasoactive drug load is less in the~     BIS- guided anesthesia group with the superficial but sufficient anesthesia level.~   "
90512|NCT02382432|"~     This study evaluated the effect of dexmedetomidine iv in three different doses in the~     treatment of shivering in patients undergoing minor elective abdominal surgery under spinal~     anesthesia, in comparison with intravenous pethidine.~   "
90513|NCT02382419|"~     This randomized phase II trial studies how well carrageenan-containing gel (vaginal gel)~     works in reducing the rate of human papilloma virus (HPV) infection in healthy participants.~     Carrageenans, which are naturally derived from seaweed, are enhancements to natural~     lubrication and may be effective in blocking HPV infection.~   "
90514|NCT02382406|"~     This is a phase I/II study for previously untreated subjects with advanced NSCLC. The study~     will take place in two phases. First, a cohort of twelve participants will be enrolled in~     phase I part and will be treated with carboplatin, nab-paclitaxel and pembrolizumab. A cohort~     of twelve subjects will be evaluated for safety and tolerability after 2 cycles of therapy.~     All subjects who receive either nab-paclitaxel or pembrolizumab will be evaluable. If 33% of~     subjects or less have unacceptable toxicity in the first cohort or any subsequent cohort (if~     necessary), the study will proceed to the Phase II part. If more than 33% have unacceptable~     toxicity, 12 additional subjects will be enrolled in a second cohort, if necessary. If~     unacceptable toxicity is seen in more than 33% in Cohort 2, the study will end due to~     unacceptable toxicity of this drug combination.~      The phase II part of the study is a single arm study. All subjects will be treated with~     carboplatin, nab-paclitaxel, and pembrolizumab in 21-day cycles for up to 4 cycles.~      Mandatory pre-treatment tumor biopsies will be obtained prior to initiating treatment for all~     subjects (only if adequate archived samples are unavailable). Mandatory tumor biopsies will~     be obtained in the Phase II part of the study after 4 cycles of study treatment or at the~     time of progression, whichever comes first.~      For subjects without progression of disease after Cycle 4, pembrolizumab will continue every~     3 weeks for up to 2 years or until unacceptable toxicity.~   "
90515|NCT02382393|"~     The purpose of this study is to evaluate the concurrent validity (correlation coefficient of~     scores at 1 time point) between the Brain Performance Test (BPT, Lumos Labs, Inc.) and a~     validated third party computerized assessment.~   "
90516|NCT02382380|"~     This study is for individuals with decreased kidney function whose doctor has ordered~     Magnetic Resonance Imaging (MRI). Because kidney function is decreased, these patients~     usually do not receive the intravenous contrast material that can improve the accuracy of the~     MRI findings. The purpose of this study is to evaluate the safety and benefit of using a~     contrast material called Gadoterate in patients with decreased kidney function.~   "
90517|NCT02382367|"~     The main objective of this trial is to evaluate the prevalence of alpha-1 antitrypsin~     quantitative and functional deficiency in an adult French population presenting with~     pulmonary emphysema. Phenotypic and genotypic studies will be carried whenever quantitative~     and/or functional deficiency will be displayed.~   "
90518|NCT02382354|"~     Structural differences of supraglottic airway devices could influence the different~     compressive forces in the oropharyngeal cavities, and require different depth of anesthesia.~     The addition of remifentanil during propofol anesthesia facilitates the insertion of~     laryngeal mask airway (LMA) with minimal adverse hemodynamic disturbances. This study was~     designed to determine the effect-site concentration of remifentanil in 50% of patients (EC50)~     and 95% of patients (EC95) for successful i- gel insertion, and compare those for LMA~     insertion during propofol target-controlled infusion (TCI).~   "
90519|NCT02382341|"~     The study seeks to document the bone in-growth into the BIOSURE™ HEALICOIL PK screw as~     measured by CT scans. Patients' improvement in pain and function will also be followed~     through various outcome measures.~   "
90520|NCT02382328|"~     The main purpose of this study is to determine the effectiveness of use Alpha lipoic acid~     before and after surgical release of carpal tunnel syndrome. Controlled Clinical trial.~   "
90521|NCT02382315|"~     Fear of cancer recurrence (FCR) is one of the most frequently cited unmet needs among~     survivors, and affects 22 to 87% of cancer patients. The objective of this study is to test~     the effectiveness of a six weekly, 1-hour manual-based individual therapy to reduce FCR among~     cancer survivors. A total of n=20 cancer survivors will be recruited from the Ottawa Hospital~     Cancer Centre (TOHCC) in Ottawa, Ontario. Participants will be randomly selected to receive~     either the psychotherapy intervention or standard care at TOHCC. All participants will be~     asked to complete a series of questionnaire packages at 3 time points. Ultimately, decreasing~     FCR can improve quality of life and reduce distress.The objective of this RCT study is to~     test the effectiveness of a six weekly, 1 hour manual-based cognitive-existential (CE)~     individual intervention to reduce FCR among cancer survivors. It is hypothesized that:~        1. Participants in the intervention group will have lower scores on the primary outcome~          measure of FCR after treatment, as compared to a standard care control group~        2. Participants in the intervention group will have lower scores on the secondary outcome~          measures of uncertainty, cancer-specific distress, intolerance of uncertainty, and~          faulty beliefs about worrying, will demonstrate enhanced coping skills, and report~          better quality of life after treatment, as compared to a standard care control group,~          and these changes will be maintained at a 3-month follow-up.~   "
90525|NCT02382263|"~     In the list of cancer mortality by type of cancer pancreatic cancer ranks 4th in USA and the~     6th in Europe. The estimated figures for 2010 in the USA were 42,000 new cases and 36,000~     deaths from pancreatic cancer. The survival rate at 5 years after diagnosis is 4.6% in the~     USA. In Europe the figures are similar, with survival at 1, 3 and 5 years of 16%, 6% and 4%,~     respectively. Most patients are diagnosed in advanced stages that are no longer operable, so~     that treatment goals are often the prolongation of survival and palliation of symptoms.~      The aim of the study is to explore whether the new combination nab-paclitaxel plus~     gemcitabine is a therapeutic advance for this fragile population for which it is assumed that~     some modifications in dose and schedule of administration may be necessary in patients with~     good performance status. It is ultimately to find out the clinical benefit of this~     combination, but first making sure that dose and schedule of the combination are tolerable~     for these fragile patients.~      For this, the investigators have chosen a design that includes two stages: the first step~     aimed at choosing the safest treatment regimen for these patients among a group of treatment~     regimens used in other clinical trials. The second step will evaluate the effectiveness of~     the two regimens with the better results in the previous step.~   "
90526|NCT02382250|"~     This study is a prospective study of patients referred for coronary angiography at Bellevue~     Hospital Center and NYU Langone Medical Center. Subjects enrolled in this study will complete~     two one-page questionnaires, including information about diet, lifestyle, perceptions of~     health and perceived barriers to healthy lifestyles. Patients will be contacted at one and~     six months following their procedure to complete follow-up questionnaires to assess changes~     in diet and perceptions of their health after knowing the results of their coronary~     angiogram. The primary outcome measure will be change in dietary patterns/perception of~     lifestyle between baseline and one- month and six-month follow-up. Secondary measures will~     include association between dietary patterns/perception of lifestyle and degree of CAD and~     socioeconomic status.~   "
90527|NCT02382237|"~     Evaluate the feasability to determine the difference of tumoral metabolism before and after~     artificial nutrition.~   "
90528|NCT02382224|"~     The purpose of this study is to examine the efficacy of a worry exposure intervention, a form~     of cognitive behavioral therapy (CBT), in comparison to a waitlist condition for the~     treatment of Generalized Anxiety Disorder. There will be a total of 60 subjects enrolled at~     the University of Texas at Austin. Patients will be randomized (like a flip of a coin) to~     either 12-sessions of WE therapy or a 12-week waitlist before being offered entry into~     therapy.~   "
90529|NCT02382211|"~     The T-SPOT assay quantifies the number of peripheral blood interferon-γ producing effector T~     cells [spot forming cells/million peripheral blood mononuclear cells - PBMC)]. The T-SPOT~     platform technology can be applied to diagnose and monitor any major disease process driven~     by a T cell response, including a viral disease such as cytomegalovirus (CMV) infection (the~     T-SPOT.CMV assay) or an allograft rejection (the T-SPOT.PRT assay).~   "
90530|NCT02382198|"~     Sialorrhea is a frequently occurring problem with detrimental effect on quality of life in~     25% of PD patients. Currently, there is no intervention approved for sialorrhea in Parkinsons~     and evidence is only available for a 30-day effect or less. We hypothesize that~     glycopyrrolate will have a lasting effect in the reduction of sialorrhea in PD patients.~   "
90531|NCT02382185|"~     Improving or maximising cardiac output in the perioperative setting through the use of goal~     directed fluid therapy has been shown to reduce complications and length of hospital stay in~     patients undergoing major abdominal surgery. The evidence for patients having surgery to~     repair a fractured neck of femur is less robust but many of these latter patients are elderly~     and often at high risk of complications.~      Patients undergoing surgery (including surgery for hip fracture) under spinal anaesthesia~     have not had access to goal directed fluid therapy because of the invasive nature of the~     existing monitoring technology such as oesophageal doppler. The availability of a non~     invasive cardiac monitoring device, the Clearsight™, now makes goal directed fluid therapy a~     possibility for this group of patients.~      This is a randomised controlled, observer blinded trial to assess the effects of goal~     directed fluid therapy in high-risk patients undergoing surgical repair of proximal femoral~     fractures.~      The aim of the trial is to test the hypothesis that maximising circulating volume~     intra-operatively with balanced crystalloid reduces post-operative morbidity in high-risk~     patients undergoing urgent surgical repair of proximal femoral fractures.~   "
90532|NCT02382172|"~     Purpose: To collect outcome measures such as eye tracking and questionnaire data prior to and~     following a group based clinical therapy program to determine the effectiveness of the~     therapy approach. The therapy program is aimed at improving social cognitions and skills of~     individuals who find social situations difficult, stressful and/or uncomfortable and with a~     desire to enhance skills required for social interactions.~      Participants: Cohorts of individuals aged 10-69 years old with symptoms of a neurodevelopment~     disorder, who have general difficulty with social interactions.~      Procedures: Participants enrolled in a clinical therapy program for improvement of social~     cognitions and skills will complete eye tracking tasks, several questionnaires and rating~     scales, and a diagnostic interview prior to and following the 8 week therapy program. The~     post treatment assessments will be conducted within a week of the therapy completion and then~     again approximately 2 months after the last therapy session. The entire study duration is~     expected to be approximately 17 weeks. These outcome measures will measure the effectiveness~     of the treatment.~   "
90533|NCT02382159|"~     1. Target disease: Patients with combined dyslipidemia accompanied by type 2 diabetes who~          has done exogenous visit or hospitalization from Jan 2010 to June 2014.~        2. Study objective:~             1. The objective of this study is to Identifying the lipid parameter variation when~               treating patients who have dyslipidemia of type 2 diabetes for 3±1 months.~             2. After treating patients who have dyslipidemia of type 2 diabetes for 3±1 months,~               identifying the reason why changing method of drug dosage and pharmacotherapy.~             3. If the drug dosage and pharmacotherapy have been changed, Identifying the lipid~               parameter variation when treating patients by altered drugs for 3±1 months,~   "
90534|NCT02382146|"~     We designed this randomized, double- blind, single-center study to compare the efficacy of~     the combination of dexamethasone with ondansetron and dexamethasone with dimenhydrinate~     undergoing plastic surgery.~   "
90537|NCT02382107|"~     The diagnosis of tuberculosis (TB) and especially the detection of drug resistance of~     tuberculosis mycobacteria can be time consuming and costly. New and rapid diagnostic tests~     are needed to improve early case detection and correct initiation of treatment.~      In the planned cross-sectional diagnostic evaluation study the investigators are aiming for~     the assessment of several new TB diagnostics (e.g. new AID strip assays and TrDNA assay in~     urine) in TB suspects who are presenting themselves to the pulmonary ambulance (TB dispensary~     for sector 4) at the Marius Nasta Institute (MNI). The study will be conducted in a~     co-operation between the MNI and the German Center for Infection Research (DZIF).~   "
90538|NCT02382094|"~     Phase III clinical trial to study quality of life in prostate cancer patients by randomizing~     anti-androgen versus total androgen blockage prior to curative intended radiation therapy.~   "
90539|NCT02382081|"~     The primary objective of this research protocol is to evaluate the health related quality of~     life and efficacy of patient-initiated hospital follow-up for patients with moderate to~     severe psoriasis.~   "
90540|NCT02382068|"~     This randomized pilot clinical trial studies dexamethasone in preventing hearing loss in~     patients receiving cisplatin. Injecting a steroid, such as dexamethasone, behind the eardrum~     before chemotherapy may help protect against cisplatin-associated hearing loss.~   "
90541|NCT02382055|"~     The investigators are examining what types of psychotherapy are most helpful for patients as~     they undergo weight restoration treatment for anorexia nervosa. In this study, patients who~     are receiving care on our inpatient unit will also receive 4 weeks of one two types of~     psychotherapy: Supportive Psychotherapy or Regulation Emotions and Changing Habits.~   "
90542|NCT02382042|"~     Background Participation in continuing care is one of the two most significant factors in~     preventing relapse after intensive Substance Use Disorder (SUD) treatment.1 A primary~     component of continuing care, social support, is a protective factor for SUD treatment~     relapse.2 Social support provided by community self-help groups (e.g. 12-step programs such~     as Alcoholics Anonymous) improves Substance Use Disorder (SUD) treatment outcomes.1,4~     Post-treatment referral to self-help groups was recently described as an effective, low-cost~     option,3 but counselors vary in their referral methods, often simply telling patients to~     find and attend meetings in their community.~      In a study of urban veterans leaving treatment, researchers increased 1-year SUD abstinence~     rates by more than 24% through a three-step intensive referral intervention.5 First,~     counselors discussed the importance of social support and meeting attendance. Second,~     counselors identified accessible self-help meetings near the SUD treatment site and arranged~     for a meeting liaison to accompany the patient to a meeting. Third, counselors followed up on~     attendance and addressed obstacles. A follow-up study found patients with co-morbid SUD and~     psychiatric problems significantly benefitted from the intervention.6~      The investigators have adapted this intervention so that it can be utilized in a rural as~     well as urban setting. The investigators have trained clinical staff, measured their fidelity~     to the intervention and successfully implemented it across three Veteran's Affairs (VA)~     Substance Use Disorder (SUD) treatment programs (Omaha, Lincoln and Grand Island). In 2012 an~     intriguing study showed that peer referral to 12-step support groups was significantly more~     effective than clinician referral.7 This is of particular interest given the scarcity of~     addiction counselors in rural communities and enhances the intervention's applicability to~     rural settings and other disciplines.~      Specific Aim The investigators propose implementing this intervention in a correction~     population (Intervention Group) and comparing outcomes between the Intervention Group and a~     group who are receiving standard correction services (Standard Group).~      Methods Phase I: Adapt Intensive Referral Intervention for correction population Phase II:~     Train correction staff in Intervention Research staff will train and continue to monitor~     trained correction staff to ensure fidelity to intervention and provide feedback to staff and~     leadership regularly.~      Phase III: Comparison between Intervention Group and Standard Group The two groups will be~     compared on measures of interest to the Nebraska Department of Correctional Services and on~     measures of substance use, support group attendance and involvement at standard time points.~   "
90543|NCT02382029|"~     Objective: Burning mouth syndrome (BMS) is chronic oral condition characterized with burning~     symptoms which affects perimenopausal and postmenopausal women. It seems that neuropathy~     might be the underlying cause of the condition. There are still insufficient data regarding~     successful therapy. The aim of this study was to compare efficacy of acupuncture and~     clonazepam in 42 BMS patients (38 women, 4 men), age range 66.7±12 years.~      Methods: Patients were randomly divided into two groups. Acupuncture was performed in group I~     during four weeks, 3 times per week on the points ST 8, GB 2, TB 21, SI 19, SI 18, LI 4 on~     both sides of the body as well as GV 20, each session lasted half an hour.Group II patients~     took clonazepam two times a day (0.5 mg) in the morning and after two weeks two tablets (0.5~     mg) in the morning and in the evening during the next two weeks. Prior to and one month after~     either therapy, participants fulfilled questionnaires: visual analogue scale, Beck depression~     inventory, LANSS pain scale, 36-item short form Health Survey (SF-36) and Montreal Cognitive~     Assessment (MoCA). Statistical analysis was performed by use of Student t test and Pearson's~     correlation test. P values lower than 0.05 were considered significant.~   "
90544|NCT02382016|"~     24-week study to evaluate the efficacy and safety of macitentan for the treatment of~     portopulmonary hypertension.~   "
90545|NCT02382003|"~     The study aims to develop a web-based Cognitive Bias Modification infrastructure to train~     interpretations, and evaluate the usability, acceptability, and feasibility of the program to~     reduce anxiety symptoms.~   "
90546|NCT02381990|"~     Registration of Prostate Cancer patients undergoing Prostate Cryotherapy guided by~     Mutiparametric-MRI (MP-MRI) highlighting biopsy confirmed regions. The primary outcome~     measure is 5 year oncological control. Secondary aim is lack of progression beyond the~     prostate gland. The aim of intervention is to eradicate prostate cancer disease in the~     treated area while imposing no or minimal deleterious effects in quality of life.~   "
90547|NCT02381977|"~     PANGEA is an international prospective point prevalence study to describe the epidemiology,~     interventions, and outcomes in children with acute critical brain disease.~   "
90548|NCT02381964|"~     When completing difficult tasks, the brain requires faster delivery of energy sources (oxygen~     and glucose) via the blood. There is evidence to suggest that some nutritional supplements~     may increase blood circulation in the brain which can result in improved task performance.~     The purpose of the study is to evaluate the effects of a multivitamin/mineral preparation~     (containing a range of vitamins and minerals as contained in commonly consumed~     multivitamin/minerals available off the shelf) in healthy females on cerebral (brain) blood~     flow and energy expenditure during cognitive task performance.~   "
90549|NCT02381951|"~     Parkinson's disease affects between 100'000 and 150'000 people in France. Drug therapy~     (L-Dopa and other drugs) is effective to improve motor symptoms but after an initial~     'honeymoon period' lasting a few years, motor symptoms reoccur in most patients, impairing~     gait and walking.~      Spinal cord stimulation is currently an important therapeutic option in the treatment of~     neuropathic pain. Experimental and limited clinical data suggest that this technique might~     also be used to alleviate motor symptoms and improve walking in Parkinsons patients.~      This exploratory study aims at measuring the benefits of spinal cord stimulation on the~     walking capacity of a small number of Parkinsons patients who are not adequately improved by~     drug therapy alone.~   "
90550|NCT02381938|"~     This study will evaluate the efficacy of a 6-month child care-based intervention to improve~     workers' physical activity and other health-related behaviors compared to an attention~     control intervention (Healthy Lifestyles vs. Healthy Finances). The study sample will use a~     cluster randomized design and a sample of 104 child care centers and 416 child care workers~     (4 workers/center). The intervention arm will receive a 6-month child care-based intervention~     designed to improve workers' moderate to vigorous physical activity (MVPA) and other~     health-related behaviors (Healthy Lifestyles). The control arm (attention control) will~     receive a similarly structured program about financial health (Healthy Finances). The primary~     outcome is workers' MVPA; and secondary outcomes include workers' dietary intake, weight,~     smoking, sleep, and stress, as well as the centers' health supportive policies/structures for~     staff wellness and the overall physical activity environment for children. All primary and~     secondary outcomes will be assessed at baseline, post-intervention (6 months), and~     maintenance (18 months).~   "
90551|NCT02381925|"~     The study aims are:~        1. To compare the diagnostic performance of parathyroid four-dimensional CT (4D-CT),~          scintigraphy, and ultrasound in patients who underwent parathyroid surgery for primary~          hyperparathyroidism.~        2. To compare 4D-CT, scintigraphy, and ultrasound for the ability to perform focused~          parathyroidectomy, and for rates of persistent hyperparathyroidism and complications~          from parathyroid surgery.~      Methods The investigators will create a multicenter registry consisting of patients having~     parathyroid surgery for primary hyperparathyroidism from July 2009 to June 2016. Initial~     participating centers include Duke University Medical Center, University California Los~     Angeles (UCLA) and University of Arkansas for Medical Sciences (UAMS).~      There will be no intervention in the patient's treatment or imaging. The management will be~     determined by the surgeon or clinician supervising the patient's care.~      The registry will consist of patient data regarding basic demographics, history of prior~     neck/chest surgery or radiation, parathyroid imaging, biochemical evaluation, intraoperative~     surgical findings, parathyroid pathology, and surgical outcomes within the first 6 months~     (persistent disease, recurrent laryngeal nerve injury, and hypoparathyroidism). Data will be~     entered into REDCap with no PHI. The investigators expect to include 3000 patients in the~     registry (1000 from Duke).~   "
90552|NCT02381912|"~     The purpose of the study is to investigate sexual function in patients suspected of non~     muscle invasive bladder cancer (NMIBC). The investigators hypothesis is that reduced sexual~     function is underdiagnosed in patients with non-muscle invasive bladder cancer and that~     active examination and treatment may worsen the sexual function.~   "
90553|NCT02381899|"~     The purpose of this observational study is to provide additional data to confirm the safety~     profile and efficacy of bendamustine and rituximab (BR) chemotherapy for chronic lymphocytic~     leukemia patients treated in routine clinical practice.~   "
90554|NCT02381886|"~     A Phase I study of IDH305 in patients with advanced malignancies that harbor IDH1R132~     mutations.~   "
90555|NCT02381873|"~     This exploratory study will quantify and describe patient-reported and objective measures of~     sensorimotor, neuromuscular, psychophysiological and genotypical performance capabilities and~     levels of habitual physical activity prior to and around the time of surgery.~   "
90556|NCT02381860|"~     Scientific studies in humans suggest that diets high in fruit and vegetables may be able to~     improve some aspects of mental performance such as improving memory and reaction times. One~     reason that that these improvements may occur is that these compounds contain phytochemicals~     which may increase blood flow and, therefore, the delivery of oxygen and nutrients to the~     brain. If this is the case it is possible to measure this increased blood flow by a~     non-invasive technique called Near Infrared Spectroscopy. The purpose of this study is to~     examine the effect of a fruit juice on cerebral blood flow and cognitive function~   "
90557|NCT02381847|"~     Patients with histological proven advanced gastric cancer (including cancer of the~     esophagogastric junction (AEG) without evidence of distant metastases, who fulfill the~     inclusion and exclusion criteria, can be recruited in this study. There are two treatment~     groups (A and B). The D2 radical gastrectomy will be applied in both groups. Patients~     randomized into group B will be treated with an intraperitoneal (in the abdominal cavity)~     chemoperfusion with cisplatin(75mg/m2 max 150mg/m2 max 5L ). Patients randomized into group A~     will not accept intraperitoneal chemoperfusion. Patients in both groups receive 6 cycles of~     postoperative chemotherapy (SOX or XELOX) within 4-12 weeks after the surgical procedure and~     are followed up for 24 months.~   "
90558|NCT02381834|"~     Urinalysis and urine culture are commonly employed laboratory tests in the Emergency~     Department (ED), particularly for the purposes of investigating febrile infants in whom~     bacterial etiologies must be ruled out. The standard of care for obtaining sterile urine~     specimens in this age group remains transurethral bladder catheterization, an invasive~     procedure that is painful and has the potential for causing specimen contamination and~     iatrogenic urinary tract infection (UTI). A recent study by Herreros Fernández et al (2013)~     described a novel bladder stimulation technique for newborns that facilitates midstream urine~     collection. The success rate for this procedure was 86.3%. It remains unknown however as to~     whether this technique is reproducible amongst infants who present to the ED with a~     potentially greater severity of illness. The primary objective of this study is to determine~     the success rate of this technique in children ≤ 90 days old in the ED.~   "
90559|NCT02381821|"~     100 patients aged 21-40 years old, diagnosed as primary or secondary infertility These~     patients are then assigned to receive ICSI treatment (ovulation induction, . They undergo a~     3D vaginal ultrasound before treatment to measure the junctional zone thickness and followed~     up after treatment to determine the rate of implantation.~      Intervention(s) All patients will undergo 3D ultrasound to measure the thickness of the~     junctional zone at day 21 of the cycle.~   "
90560|NCT02381808|"~     To understand 295 gene mutation mutation status (include EGFR, HER2, KRAS, BRAF, PIK3CA,ect)~     by deep sequencing in Chinese patients with pulmonary adenocarcinoma and their relationships~     with the patients' clinical features (including sex, age, smoking history and adenocarcinoma~     subtype), specify the predictive significance of the genes mutations for new targeted~     therapies in NSCLC patients, and better understand the molecular mechanism drug resistance to~     EGFR-TKIs.~   "
90657|NCT02380534|"~     To evaluate the effects of H.E.L.P. apheresis on lipid profile, Lp(a) level, and some~     inflammatory adypocytokines in patients with high cardiovascular risk.~   "
90561|NCT02381795|"~     This is an open label, investigator-sponsored, pilot study. Subjects agreeing to participate~     in the study and meeting the eligibility criteria assessed at the screening visit will be~     enrolled in the study. The length of time between screening and treatment will last between 0~     days to a maximum of 12 weeks. Subjects who enter the screening phase during a cluster~     headache episode and meet the study eligibility criteria can immediately enter the treatment~     phase and may opt to treat their cluster headache episode in the clinic. Subjects who are not~     in a cluster headache episode, who meet initial screening eligibility criteria, can remain in~     the screening phase for up to 12 weeks until their next cluster episode begins. Upon~     initiation of a cluster headache episode, subjects will enter the treatment period. Subjects~     will be trained on the proper use of the hand-held dispenser containing carbon dioxide (CO2~     )calibrated to deliver 0.5 standard liters per minute (SLPM). This dispenser will be provided~     for use in the clinic or home. Subjects will be instructed to use the nasal CO2 dispenser, 10~     seconds/nostril, as needed up to 6 times to treat one attack. Each dose must be separated by~     3-5 minutes. Subjects should treat only one attack in a 24-hour period. Subjects may treat up~     to three cluster headache attacks during the treatment phase of this study. One hour after~     the first dose, subjects can choose to treat with investigator-approved rescue medication.~     Subjects will be asked to complete an online diary after the completion of the dosing. Diary~     assessments will collect pain severity, nasal CO2 usage, acute medication usage, satisfaction~     of treatment, number of cluster attacks, and unusual symptoms. Subjects will be contacted by~     phone within 3 days of the first use of the nasal CO2 dispenser to assess adverse events~     (AEs) and medication usage. A total of 25 subjects will enter the treatment period and be~     instructed to treat up to 3 cluster headaches with nasal CO2. Within 7 days of treating their~     last cluster headache episode, subjects will return for an end of study visit.~   "
90562|NCT02381782|"~     Over the last few years, there has been a considerable interest in the development of~     screening tools to assess the capability of elderly cancer patients to tolerate anti-cancer~     treatment. Therefore, the NCCN Guidelines in Senior Adult Oncology recommend an assessment of~     co-morbid conditions that are likely to interfere with cancer treatment and tolerability. As~     presbyacusis is common in an older population, elderly cancer patients are at high risk for~     social isolation and a reduced quality of life. Therefore, in this project the investigators~     aim to validatie uHear™ as a quick and reliable screening tool to screen for presbyacusisf in~     routine clinical oncology practice.~   "
90563|NCT02381769|"~     The study will be an experimental pre-post trial in which patients with ethanol related liver~     disease (both severe alcoholic hepatitis and decompensated ) admitted in our institute from~     Jun 2013-Dec 2014 will be enrolled in the study. Those on ryle's tube feeding would receive~     polymeric blenderized kitchen based liquid diet while those tolerating orally would receive~     soft/ solid diet as tolerated as per requirement. All the patients would receive same amount~     of calories i.e., 30-35 kcal/kg ideal body weight/ day and 1-1.2 gm/kg protein. 35-40% of non~     protein calorie would be provided as fats and rest of the calories will be provided as~     carbohydrates. All patients will be transfused 250ml of 20% intra lipid per day for 3~     consecutive days, over and above the feed provided to them to be taken enterally (orally or~     through Ryle's Tube). Patients will undergo tests prior to infusion and 72 hours after~     infusion.~   "
90564|NCT02381756|"~     The aim of this study is to evaluate, in an intensive care unit, the reproducibility between~     two non-cardiologists operators and a cardiologist expert in echocardiogram, of the Simpson~     method and of the calculation of GLS for the evaluation of the systolic function of the left~     ventricle in critically ill patients intubated and ventilated.~   "
90565|NCT02381743|"~     Community health workers (CHWs) provide essential basic medical care to hundreds of millions~     of people across the globe. CHWs offer a myriad of services including community sanitation,~     breast feeding counseling, family planning, management of febrile children, and malaria~     control and prevention, to name but a few. In fact, CHWs are often the only source of primary~     health care available to some of the most disadvantaged populations in the world. However, to~     be effective, CHWs must be trained - and retrained - at regular intervals, and the costs for~     such trainings can be substantial. In the US, clinicians are required to stay current and~     maintain their competence through continuing medical education (CME). Increasingly, CME~     activities are delivered via internet-based, self-teaching modules. A typical example would~     be a set of topical readings followed by multiple-choice questions, with the answers, and CME~     credit, provided to the user upon satisfactory completion of the module. This content is~     typically delivered over the Internet. However, there is no intrinsic reason why this~     approach could not be adapted so that CME activities are delivered using standard cell phones~     via SMS text messaging. This would significantly expand professional training opportunities~     to a far greater range of CHWs than possible through computer/tablet/smart phone platforms,~     and would be particularly valuable in poorer countries with limited training budgets. In the~     mCME project, the investigators propose to test the effectiveness and cost effectiveness of a~     mobile phone-based CME delivery strategy among Vietnamese community-based physician~     assistants (CBPAs), a cadre of CHW mandated to provide primary health care to rural and~     disadvantaged populations. The investigators hypothesize that providing CME activities over a~     mobile platform will significantly improve their professional knowledge, and may also improve~     their job satisfaction and self-efficacy.~   "
90566|NCT02381730|"~     Polypoidal choroidal vasculopathy (PCV) is a disease of the choroidal vasculature, that is~     often regarded as a sub-type of age-related macular degeneration (AMD). However, PCV response~     to anti-vascular agents differs from the response of typical AMD.~      This study aims at describing the evolution of the best corrected visual acuity (BCVA) in PCV~     patients, 28 weeks after they receive one injection of intravitreal aflibercept (2mg).~   "
90567|NCT02381717|"~     The goal of the study is to evaluate whether pain control achieved by Ultrasound Guided~     Femoral Nerve Blockade (USFNB) is equal in efficacy to standard pain management practice of~     parenteral injection of opioid pain medication in patients presenting to the emergency~     department (ED) with hip fracture.~   "
90568|NCT02381704|"~     The overall purpose of the study is to determine prospectively the cost effectiveness of~     bariatric surgery following partial coverage by a large healthcare system.~   "
90569|NCT02381691|"~     Objective : To assess the analgesic effect of maternal breast milk odor in preterm neonates~     Design : A prospective, randomised, controlled, double blinded, monocentric trial.~      Méthods : The neonates were included from 01/01/2012 to 31/12/2014. Inclusion criteria were:~     neonates fed with their mother breast milk, gestational age between 30 weeks of amenorrhea~     and 36 weeks + 6 days, a postnatal age ≤ 10 days and a birth weight greater than the 5th~     percentile according to Olsen curves et al. They also had to be: clinically stable, with 48~     hours withdrawal of nasal CPAP, without administration of any analgesic or sedative drug in~     the last 48 hours and without any underlying disease. The two legal representatives must have~     signed an informed consent. The study excluded the neonates for whom no video was recorded~     during the venipuncture.~      In the first group breast milk, venipuncture was performed to the neonate while his~     mother's milk odor was being diffused. In a second control group, the same gesture was made~     with an odorless diffusor. The primary outcome was the clinical score assessment PIPP~     (Premature Infant Pain Profile). The secondary outcomes were the DAN score (Acute Pain of~     Newborn) and the salivary cortisol level.~   "
90588|NCT02381444|"~     The aim of this study is to assess the effect of LCIG (levodopa-carbidopa intestinal gel) on~     HRQL (Health-Related Quality of Life) of participants and compare the Health-Related Quality~     of Life between participants continuing to levodopa-carbidopa intestinal gel treatments~     versus participants continuing on oral therapy for Parkinson's Disease.~   "
90570|NCT02381678|"~     The objective of the study is to obtain the clinical data from patients who had the Perimount~     Heat Valve (Type:6900P and 2900) Replacement Surgery in Guangdong General Hospital during~     2001-2007 in order to evaluate the performace of this heart valve prothesis and collect the~     patients' post-operation infomation including the current living status, mortality rate, and~     the possibility of re-operation，bleeding and thrombosis.~      This is a retrospective , observentional clinical study to be conducted in Guangdong General~     Hospital in China. This study will enroll up to 200 patients.~   "
90571|NCT02381665|"~     Chronic constipation is a strong public health problem. Its prevalence is about 15% in~     Western countries with a significant impact on quality of life and health care costs . Two~     subtypes of constipation can be identified: slow transit constipation (STC), characterized by~     impaired propulsion of stool and due to dysfunction of colonic smooth muscle (myopathy) or~     its innervation (neuropathy), or both; and evacuation disorders, characterized by difficulty~     or inability with stool expulsion. They include disorders of the anorectal function such as~     dyssynergic defecation, as well as structural disorders such as rectocele, descending~     perineum syndrome and rectal prolapse .~      The first line therapy of chronic constipation is based on medical treatment combined with~     laxatives and dietary rules. However, these treatments are often disappointing. In case of~     failure, few treatment options are currently available. Surgery can sometimes be discussed~     for intractable chronic constipation. Sub-total colectomy can be proposed in case of STC but~     is associated with a significant morbidity. In case of pelvic floor disorders, a specific~     surgical treatment can be indicated. However, surgery is invasive, has a significant~     morbidity and the results are inconsistent. Recently, some studies have assessed the efficacy~     of sacral neuromodulation in the treatment of chronic constipation with some success, but~     this technique is expensive and requires the surgical implantation of a medical device . More~     recent works, including a randomized trial have showed, in children, the efficacy of~     interferential current stimulation in the treatment of chronic transit constipation . This~     treatment is used daily, at home, and uses four adhesive surface electrodes, two abdominal~     (placed below the costal margin) and two paraspinal (placed between T9 and L2) producing two~     sinusoidal currents crossing the body, 1 hour per day for 1-3 months. To date, only one~     open-label study has evaluated this technique in adults and has shown encouraging results in~     three months with an efficiency on 7/11 patients (63.6%) in the number of stools, severity~     score of constipation, quality of life's score associated with improved bowel transit time~     measured by radio-markers.~      Interferential therapy is a new treatment that has demonstrated its efficiency in the~     treatment of chronic constipation in children. Our team has published the first and only~     pilot study in adults that also demonstrated encouraging results. These data are of~     particular interest since laxative treatments are often disappointing, are expensive and may~     have adverse events.~      This study would be the first randomized study to evaluate a non-invasive and~     non-pharmacological treatment of chronic constipation in adults.~      If its effectiveness is demonstrated, it will provide, for the first time, a new non-invasive~     step for patients with laxative treatment failure before considering surgical treatment.~   "
90572|NCT02381652|"~     The objective of this study is to evaluate the safety of a repeat injection of Cingal® in~     subjects with Osteoarthritis (OA) of the knee who participated in Cingal 13-01. This will be~     done through examination of the incidence of adverse events and physical examination of the~     knee.~   "
90573|NCT02381639|"~     The current etiological pathological model of anorexia nervosa is poly-factorial involving~     individual genetic and psychological factors, in close interaction with environmental, family~     and socio-cultural factors.~      Among these factors, this study focuses on the central coherence process (cognitive ability~     to integrate complex information into a comprehensive meaning), in the active phase of the~     disease. Therefore, patients followed in the addiction service of the Nantes University~     Hospital will perform neuropsychological tests assessing executive functions involved in the~     process of central coherence.~      Impairment of central coherence process could act as a maintenance factor of the disease,~     particularly in connection with body dysmorphic disorder. The therapeutic perspectives acting~     on the central coherence process like cognitive remediation deserve to deepen knowledge on~     the cognitive profile of patients with anorexia nervosa.~   "
90574|NCT02381626|"~     The purpose of this study is to look at air quality in cabs and see if the air quality inside~     taxi cabs is connected to increased risks for lung and heart health problems. Another purpose~     of the study is to see if putting an air filter inside the car may help improve the air~     quality and lower health risks.~      This is important because air pollution can be harmful to health. Air pollution is made up of~     very tiny particles (things) floating in the air around us, called particulate matter.~     Particulate matter is made up of dust, smoke, dirt, and gas fumes and can get into our bodies~     as we breathe. It has been linked to risk for lung cancer and heart disease. It is important~     because taxi drivers spend many hours of their day inside their cars.~      The investigators hope that this study will help them find out if using air filters inside~     cabs will help lower the levels of pollution in cabs and reduce its effects on the health of~     taxi drivers. They will use these results to educate the taxi driver community.~   "
90575|NCT02381613|"~     While observational studies often find that diets rich in fish reduce the risk of disease,~     and that diets including a high intake of red meat are associated with increased risk of~     cardiovascular disease and cancer, the difference in health effects between red meat and fish~     are rarely researched in intervention studies.~      The investigators hypothesise that the post-prandial plasma response of lipids and markers of~     cardiovascular disease risk will be more favourable after intake of herring compared to beef.~      In addition, while pickling herring in a brine/sugar solution is a common form of~     preparation, little is known if there is a difference in potential health effects based on~     the preparation of herring. The investigators will compare baked and pickled herring to~     understand if preparation is potentially an important factor to be considered when looking at~     intake of fish and health.~   "
90576|NCT02381600|"~     Background: Ageing is associated with an increased risk of cognitive decline and depression.~     Vitamin D plays an important role in many of the symptoms and conditions related to advanced~     age, including impaired balance, falls and osteoporosis. Vitamin D also has a physiological~     effect on the function of the central nervous system, and studies have suggested a~     relationship between this vitamin and changes in affect and cognitive function in the~     elderly. The investigators propose a pilot study to examine the relationship between~     below-normal levels of Vitamin D to affective symptoms and specific cognitive functions in~     the elderly.~      Methods: A total of 30 subjects of both genders older than 65 years with levels of 25-OH~     Vitamin D lower than 30 ng/ml on routine laboratory screening will be referred by the~     treating family physicianfor screening. Subjects will be required to provide written informed~     consent for inclusion in the study. Exclusion criteria will include any active or unstable~     medical condition as determined by the treating physician, known neurocognitive disorder,~     known affective disorder, the use of any class of antidepressant drugs, the use of~     supplements containing vitamin D in any dose, significant visual or hearing impairment not~     corrected by spectacles or hearing aids, and a level of literacy that limits cognitive~     ability. All subjects will undergo cognitive screening by use of the MoCA test, computerized~     cognitive assessment using the the Neurotrax (®Mindstreams) computerised cognitive assessment~     battery, and the 15-item Geriatric Depression Scale. All subjects will undergo repeat testing~     for level of 25-OH Vitamin D, and where below-normal levels are confirmed patients will~     receive a supplemental monthly oral dose of 60000 units Vitamin D administered by a nurse for~     a period of 3 months. At 3 months subjects will undergo repeat testing for level of 25-OH~     Vitamin D, and repeat computerized cognitive assessment using the Neurotrax Mindstreams~     battery and the 15-item Geriatric Depression Scale (GDS).~   "
90668|NCT02380378|"~     This study was developed to document current diagnosis and treatment patterns, clinical~     outcomes, and health care resource use associated with Philadelphia-Negative~     Myeloproliferative Neoplasms, in the different risk classifications for each disease.~   "
90577|NCT02381587|"~     sjogren syndrome is an autoimmune disease that mainly affects the Salivary glands and~     Lacrimal gland In addition to the effects of this disease is characterized by overall~     systemic Muskals injury, pulmonary disease, peripheral neuropathy and vasculitis. In addition~     recent studies have shown that patients are at increased risk of the disease up to 2 cardiac~     events and stroke events Hydroxychloroquine is an RHEUMATIC DISEASE PROCESS~     SUPPRESSANTS-ANTIMALARIALS used to treat anti-inflammatory rheumatic diseases in many~     first-line treatment is sjogren syndrome.~      A recent study of the treatment in Hydroxychloroquine effect on lipid profile sjogren~     syndrome patients showed a reduction in total cholesterol levels and increase in HDL. Further~     studies of the impact made Hydroxychloroquine systemic lupus patients erythematosus (SLE)~     showed in Atherosclerosis and morbidity and mortality reduction in cardiovascular. Studies of~     patients with rheumatoid arthritis (RA) demonstrated reduced risk of developing diabetes and~     improved lipid profile Research Goals valuate The effect of HCQ treatment in cardiovascular~     patients with primary sjogren syndrome~   "
90578|NCT02381574|"~     Primary Objective:~      To evaluate the rate of re-operation during the first 5 years following the fitting of lumbar~     total disk replacement at the operated level and / or floors above and / or underlying,~     whatever the reasons~   "
90579|NCT02381561|"~     This phase I trial studies the side effects and best dose of ropidoxuridine in treating~     patients with gastrointestinal cancer that has spread to other places in the body and usually~     cannot be cured or controlled with treatment undergoing radiation therapy. Ropidoxuridine may~     help radiation therapy work better by making tumor cells more sensitive to the radiation~     therapy.~   "
90580|NCT02381548|"~     This phase I trial studies the side effects and best dose of WEE1 inhibitor AZD1775 and~     belinostat when given together in treating patients with myeloid malignancies that have~     returned after a period of improvement or have not responded to previous treatment or~     patients with untreated acute myeloid leukemia. WEE1 inhibitor AZD1775 and belinostat may~     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~   "
90581|NCT02381535|"~     This phase I trial studies the side effects and best dose of onalespib when given together~     with intensity-modulated radiation therapy (IMRT) and cisplatin in treating patients with~     squamous cell carcinoma of the head and neck that has spread from where it started to nearby~     tissue or lymph nodes. Onalespib works by blocking a protein called HSP90. HSP90 helps~     protect cells from stress and supports many other proteins that cause cell growth. When HSP90~     is blocked, tumor cell growth may be slowed or stopped and may die more easily when treated~     with chemotherapy and radiation. Drugs used in chemotherapy, such as cisplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. IMRT is a specialized radiation~     therapy that delivers beams of radiation of different intensities aimed at the tumor from~     many angles and may kill more tumor cells and cause less damage to normal tissue. Giving~     onalespib with cisplatin and IMRT may kill more tumor cells.~   "
90582|NCT02381522|"~     The purpose of the study is to investigate if briefly stopping blood flow to the patient's~     leg will lead to the patient's body being better able to tolerate possible decreased blood~     flow to regions of the brain which otherwise frequently happens after subarachnoid~     hemorrhage.~      Previous studies show that various organs such as the heart, brain or kidney can tolerate~     longer periods of decreased blood flow if prior to that insult shorter periods of decreased~     blood flow were experienced.~   "
90583|NCT02381509|"~     PRESERVE is a multi-center, prospective, open-label, non-randomized investigation of~     commercially available IVC filters from 6 manufacturers placed in subjects for the prevention~     of pulmonary embolism (PE). This study will enroll approximately 1,800 IVC filter subjects at~     up to 60 sites in the US. All treated subjects will be evaluated at procedure, 3-months,~     6-months (phone), 12-months, 18-months (phone), and 24-months post-procedure. The primary~     objective of this investigational device exemption (IDE) clinical investigation is to~     evaluate the safety and effectiveness of the commercially available IVC filters (retrievable~     and permanent) in subjects with clinical need for mechanical prophylaxis of PE with an IVC~     filter.~   "
90584|NCT02381496|"~     This is a three-part study to assess the tolerability, safety, pharmacodynamics, and~     pharmacokinetics of ascending single doses (including food interaction) of ACT-453859 in~     healthy male subjects, of ascending multiple doses of ACT-453859 in healthy male and female~     subjects, and of multiple doses of setipiprant (ACT-129968) in healthy male and female~     subjects.~   "
90585|NCT02381483|"~     Vitamin A metabolites (retinoids) have shown to activate brown fat function in preclinical~     studies, however the role of retinoids in human brown fat physiology and energy metabolism~     remains elusive. This study aims to identify a possible association between retinoid~     metabolism, brown fat activity, and energy expenditure in lean and obese subjects by using~     FDG-PET-CT, PET-MR Scans and indirect calorimetry. Additionally we will analyze the genetic~     profile of white and brown neck fat biopsies at room temperature and cold conditions in a~     subset of the study participants. More detailed molecular studies (involving other potential~     browning markers) will also be performed in adipocytes derived from human SVC.~      The optimal duration of cold exposure will be determined in a pilot study. Therefore subjects~     will be repeatedly exposed to cold and circulating retinoid levels and other plasma~     parameters will be measured at various time points.~   "
90586|NCT02381470|"~     Faropenem is an oral penem, closely related to the carbapenem class that is used for the~     treatment of bacterial infections. It has in vitro activity against Mycobacterium~     tuberculosis and this trial aims to determine the activity of faropenem with~     amoxicillin/clavulanic acid in patients with pulmonary TB.~   "
90587|NCT02381457|"~     This multi-center prospective observational study is designed to track birth outcomes and~     perinatal correlates to the Panorama prenatal screening test in the general population among~     ten thousand women who present clinically and elect Panorama microdeletion and aneuploidy~     screening as part of their routine care. The primary objective is to evaluate the performance~     of Single Nucleotide Polymorphism (SNP)-based Non Invasive Prenatal Testing (NIPT) for~     22q11.2 microdeletion (DiGeorge syndrome) in this large cohort of pregnant women. This will~     be done by performing a review of perinatal medical records and obtaining biospecimens after~     birth to perform genetic diagnostic testing for 22q11.2 deletion. Results from the follow-up~     specimens will be compared to those obtained by the Panorama screening test to determine test~     performance. Specific test performance parameters will include: PPV, specificity, and~     sensitivity.~   "
90589|NCT02381431|"~     The purpose of this study is to see if thermal images can be used instead of a chest x-ray to~     diagnose bacterial pneumonia in children with signs and symptoms of pneumonia in Nagpur,~     India. More specifically, the objectives of the study are: 1) to determine if thermal~     imaging, using a commercial thermal camera can accurately detect the presence of bacterial~     pneumonia in children receiving a chest x-ray to rule out pneumonia; 2) to evaluate the use~     of thermal imaging to monitor the course and resolution of pneumonia in children diagnosed~     with pneumonia; and 3) to determine if thermal imaging can accurately diagnose sites of~     infection that are suspected to be related to the pneumonia.~   "
90590|NCT02381418|"~     Influenza (flu) viruses change continuously, therefore also the parts of viruses used in~     influenza vaccines can vary from year to year. The current study is a phase III A clinical~     trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. The~     objective of this study is to investigate the immunogenicity and safety and tolerability of~     the changed influenza vaccine virus composition in two groups of subjects in good health:~     subjects aged >= 18 and <= 60 years and subjects >= 61 years of age (elderly).~   "
90591|NCT02381405|"~     This is an open label, randomized investigation of a proprietary blend of amino acids, called~     Enterade®, and its effect on irregularity (diarrhea) caused by radiation therapy and/or~     chemotherapy including TKI*. Subjects will be randomized to receive Enterade® or continue~     standard of care. Two patients will be enrolled on the treatment arm for each patient on the~     control arm.~   "
90592|NCT02381392|"~     Obtaining intravenous (IV) access in children under the age of 2 years is difficult,~     especially in the emergency department (ED) where the children can be frightened, dehydrated~     and ill. Often it requires multiple needle sticks and nurses to place an IV in a difficult~     child. In our ED the recently acquired an Accuvein AV400 device. This infrared light, like a~     barcode scanner, makes the veins on a child appear like roads on a map. This ideally shows~     the nurse where to place and direct the needle. This device is approved by the FDA to work~     with children and has not been shown to have any harmful effects. However, there are no~     studies showing whether this device helps in the difficult less than 2 year olds seen in the~     emergency department.~      This study will be to directly compare placing an IV in a child under 2 years of age with the~     AV400 versus not using the device. A physician, medical student, or nurse practitioner who~     has been trained on how to observe nurses place IVs will enroll children who require an IV~     for their ED clinical care (as determined by their ED doctors). This person will consent the~     parents, ask the parents questions regarding the child's past medical history, and have the~     nurse look at the veins of the child ahead of the IV access attempt to rate the level of~     difficulty expected (easy, moderate, difficult). Whether the child has the IV attempt~     performed with or without the AV400 will be computer randomized. The nurse will attempt to~     place the IV, and the study staff will observe and record the number of attempts, size of the~     IV catheter, and location of the IV. If 2 attempts are failed, the patient will cross over~     to the other condition, that is if AV400 was being used then it will not be used, and if~     AV400 was not being used then it will be used. If there are 4 failed attempts at IV~     placement, then the child will be treated as per our department's difficult IV access~     protocol, which is applied to all children with difficult IV access regardless of~     participation in the study. After the IV placement, both the parents and the nurse will be~     asked several questions regarding satisfaction with use of the AV400.~      No patient identifiers will be collected.~      The investigators will be recruiting 260 children to determine if using the AV400 device~     improves the first time needle stick success from 40% to 60%.~      Nursing approval for the study was obtained prior to the study.~   "
90593|NCT02381379|"~     To compare administration of peginterferon-α-2a for 1 year versus observation after stopping~     tyrosine kinase inhibitor (TKI) in chronic myeloid leukemia (CML) patients with deep MR ≥ 2~     years.~   "
90594|NCT02381366|"~     PNEUMOSTEM® consists of ex vivo cultured allogeneic, unrelated, human umbilical cord~     blood-derived mesenchymal stem cells (hUCB-MSCs) and it is intended for use as a cellular~     therapy product for prevention of Bronchopulmonary Dysplasia (BPD). This study is an~     open-label, single-center, dose escalation study to evaluate of safety and efficacy of~     PNEUMOSTEM® in premature infants at high risk for BPD.~   "
90595|NCT02381353|"~     After surgery to remove the eye, either by enucleation or evisceration, patients have~     variable levels of pain for several postoperative days. Some patients have almost no~     discomfort while others require significant amounts of oral narcotics and report pain of 10~     out of 10 on a numerical rating scale. The current operative standard is to infiltrate the~     eye socket with 0.5% bupivacaine during surgery leading to several hours of postoperative~     analgesia. In 2011, Pacira Pharmaceuticals released a bupivacaine liposomal injectable~     suspension (Exparel, 1.3%) which offers sustained release of bupivacaine giving postoperative~     pain control for up to 72 hours. This medication has been used in numerous surgeries~     including inguinal hernia repair, hemorrhoidectomy, bunionectomy, breast reconstruction, and~     orthopedic surgery, and the literature reports improved pain control, decreased use of oral~     opioids, and increased patient satisfaction. There are no reports of the use of Exparel in~     the ophthalmic literature. The investigators propose a randomized, controlled trial to~     compare the postoperative pain control offered by sustained release bupivacaine to that~     offered by standard plain bupivacaine after enucleation or evisceration.~   "
90596|NCT02381340|"~     Obesity and its associated conditions have reached epidemic proportions. Estimates are that~     about one third of the adults in the United States have obesity. At this moment there are~     many therapeutic approaches for the treatment of obesity. But, efficacy of most treatment~     options are limited and so far surgical intervention has been proven to be the only strategy~     to overcome severe obesity. However, bariatric surgery has limitations and risks, which might~     be minimized by non-incisional endoscopic procedures.~      BaroSense developed a new device, called the Articulating Circular Endoscopic (ACETM)~     Stapler, which can be used in the treatment of obesity. It is a trans-oral procedure, which~     intends to reduce the ability of the stomach to expand by creating plications in the region~     of the fundus and greater curvature. In contrast with other bariatric surgery it is~     endoscopically performed, reversible and if it fails most future surgical options are still~     open.~      The main study ('Open, prospective study to evaluate the safety and preliminary effectiveness~     of the BaroSense ACE™ Stapler for the treatment of obesity', multicenter study (MUMC+, AMC~     and St. Antonius), accepted by MEC AMC) seeks to determine the safety and efficacy of this~     plicating system for patients with severe obesity.~      In this sub-study the investogators want to unravel the exact mechanism and provide more~     information about the efficacy of the BaroSense ACE™ Stapler. Therefore the authors will~     measure changes in various parameters that are known to affect weight loss and metabolism,~     before and after gastric plication (by using the BaroSense ACE™ Stapler) in overweight~     subjects (these parameters will only be measured in patients at MUMC+). These parameters are~     post-prandial satiety, food-reward and related brain signalling, gastric emptying, behaviour~     towards food, food intake, satiety hormone release, microbiota composition and inflammatory~     markers.~      Objectives:~      Aim of the present study will be to assess the effect of the BaroSense ACE™ stapler on~     postprandial satiety, food-reward and related brain signalling, gastric emptying, behaviour~     towards food, food intake, hormone release, microbiota composition and inflammatory markers.~   "
90608|NCT02381184|"~     One hundred and thirty six anovulatory women with CC-resistant PCOS were scheduled randomly~     into two equal groups. Group A (n=68); received CC (100 mg/day from cycle day 3 for 10 days)~     for up to six cycles. Group B (n=68) underwent LOD and followed up for 6 months. The primary~     outcome was the ovulation rate in each group; secondary outcomes were midcycle endometrial~     thickness and serum estradiol, midluteal serum progesterone, and the rates of clinical~     pregnancy and abortion.~   "
90609|NCT02381171|"~     To evaluate the hypothesis: the effects of repetitive transcranial magnetic (rTMS)~     stimulation and/or peripheral stimulation (neurofunctional electrical acupuncture) treatments~     are more effective in pain relief than placebo-sham in patients with myofascial chronic pain.~   "
90597|NCT02381327|"~     Patients diagnosed with Binge Eating Disorder (BED) overeat food but, as opposed to patients~     with bulimia nervosa, they do not compensate for their increased food intake and therefore~     their body weight increases. It is hypothesized that the speed of eating has increased in BED~     and that body weight will decrease if the speed of eating is decreased. The speed of eating~     is measured using Mandometer, an eating disorder conditioning tool, class 2 device cleared by~     the FDA for the treatment of eating disorders. Mandometer is a scale connected to a computer,~     patients eat food from a plate on the scale and the computer stores the weight loss of the~     plate, thus recording the speed of eating. Patients decrease their speed of eating by~     following training curves on the computer screen while eating. The emergence of their own~     speed of eating on the screen makes this possible. Patients use Mandometer for lunch and~     dinner over one week at home to estimate their speed of eating and their food intake as the~     first step of clinical pratice. Mandometer is then programmed with how much and how quickly~     to eat and patients practice eating using Mandometer at home over the subsequent treatment.~     Data from 166 BED-patients using Mandometer at home and from a total of 354 patients who have~     been treated have been collected. 30 normal weight, healthy subjects will be recruited to~     test the hypothesis that their speed of eating is lower than that of the BED-patients. These~     control subjects will eat lunch and dinner using Mandometer at home over one week, but they~     will, obviously, not participate in treatment.~   "
90598|NCT02381314|"~     The purpose of this study is to evaluate the safety of enoblituzumab (MGA271) in combination~     with Yervoy (ipilimumab) when given to patients with B7-H3-expressing melanoma, squamous cell~     carcinoma of the head and neck (SCCHN), non small cell lung cancer (NSCLC) and other B7-H3~     expressing cancers. The study will also evaluate what is the best dose of enoblituzumab to~     use when given with ipilimumab. Assessments will also be done to see how the drug acts in the~     body (pharmacokinetics (PK), pharmacodynamics) and to evaluate potential anti-tumor activity~     of enoblituzumab in combination with ipilimumab.~   "
90599|NCT02381301|"~     Coronary artery disease (CAD) is the leading cause of morbidity and mortality in developed~     countries. In addition, many patients suffer from valvular and aortic disease. Although~     various tools are available to identify patients with cardiovascular (CV) disease at risk for~     major adverse cardiac events (MACE), the identification of these patients remains a clinical~     challenge.~      One promising avenue is the use of different serum biomarkers involved in atherothrombosis~     which could provide an easy and cost-effective step in risk stratification.~   "
90600|NCT02381288|"~     The purpose of this study is to evaluate the effects on serum testosterone (ST) after 6 weeks~     of subcutaneous (SC) administration of different doses and dosing frequencies of TAK-448 to~     middle-aged and older men with low ST levels.~   "
90601|NCT02381275|"~     Lighthouse, in cooperation with the University Heidelberg Public Health Institute and the~     University Köln (Cologne) would like to set up a cohort to study baseline characteristics and~     long-term clinical outcomes of patients using Tenofovir based Antiretroviral Therapy at the~     Lighthouse. As of March 2014, patients above 18 years and giving informed consent coming to~     the Lighthouse to newly initiate ART will be approached to enroll in the cohort.~      The results will be disseminated both nationally at the Ministry of Health Technical Working~     Group (TWG), at the annual Research Dissemination and Best Practices conferences of the~     College of Medicine and National AIDS Commission as well as internationally. The results will~     also be written up for publication in appropriate peer-reviewed journals.~   "
90602|NCT02381262|"~     Study Aims Specifically with our Healthy Weight Management patients that are pursuing sleeve~     gastrectomy surgery, the investigators would like to determine if the Fitbit is associated~     with health outcomes in this population.~      Primary Outcome~      • Percentage of excess weight loss - Does the use of a Fitbit positively affect the~     percentage of excess body weight loss in vertical sleeve gastrectomy patients?~      Secondary Outcomes~        -  Lifestyle changes and Exercise patterns - Does the use of a Fitbit foster positive~          lifestyle and exercise pattern changes in post-operative VSG patients?~        -  Resolution of comorbidity - Does the use of a Fitbit positively affect patient health~          via reduction of co-morbid conditions associated with morbid obesity following VSG~          surgery?~   "
90603|NCT02381249|"~     Improvements to treatment strategies for patients with cancers of the upper gastrointestinal~     tract have produced a large population of people who remain free from cancer recurrence in~     the long term following treatment.~      Surgery is the cornerstone of treatment for patients with these cancers, but while surgical~     removal of the tumour may offer the best chance of cure, these are major operations~     associated with specific long term complications. Weight loss and poor nutrition are common~     problems among patients who attain long-term cancer remission and cure after surgery. The~     mechanisms underlying these problems are not well understood and therefore treatment options~     are limited.~      Our research has demonstrated increased levels of chemical messengers (gut hormones) released~     from the gastrointestinal tract after meals in patients who have previously undergone this~     type of surgery. These chemical messengers play a role in controlling appetite and interest~     in food, and increased levels after surgery may reduce interest in eating. Understanding the~     role of gut hormones in the control of appetite may allow us to use certain medications to~     block gut hormones and hence increase appetite, allowing patients to eat more and regain~     weight, preventing nutritional problems after surgery.~      In this study, the investigators aim to determine whether exaggerated gut hormone secretion~     causes reduced appetite and interest in food after surgery. The information gained from this~     study may help us to develop treatments for patients with weight loss and nutritional~     problems after surgery.~   "
90604|NCT02381236|"~     A single-arm, open-label Phase II clinical trial to evaluate the effect of G-202 on the~     perfusion and volume of the prostate using non-invasive multiparametric prostate magnetic~     resonance imaging (mpMRI).~   "
90605|NCT02381223|"~     This study aims to collection additional data on the safety and acceptability of medical~     abortion without pretreatment pelvic ultrasound or exam in woman who meet certain criteria.~   "
90606|NCT02381210|"~     A cross sectional study design will evaluate the diagnostic value of the CRD test to the~     pregnant women attending the Dhaka Medical College Hospital and Hospital Materno-Infantil~     Inguarán, tertiary level facilities in Bangladesh and Mexico City.~   "
90607|NCT02381197|"~     A population-based prospective cohort design will evaluate the progression of urine~     congophilia in pregnancy using the Congo Red Dot test by following patients longitudinally~     across gestation in Bangladesh and Mexico City.~   "
90611|NCT02381145|"~     In this double-blind, randomized, placebo-controlled study, we aim to investigate the effects~     of a long-term supplementation on insulin sensitivity, mitochondrial function and substrate~     metabolism in healthy overweight men and women.~      In each group, 21 subjects consume 100mg Resveratrol (RSV) and 150mg Epigallocatechin-gallate~     (EGCG), respectively Placebo capsules, twice daily over a period of 12 weeks. The subjects~     receive the capsules after the last pre-measurement and continue to take them throughout the~     post-measurements.~      Before and after the supplementation period, we perform a hyperinsulinemic-euglycemic clamp~     with a glucose-tracer infusion to assess hepatic and systemic insulin sensitivity.~     Simultaneously, substrate oxidation is measured throughout the clamp by indirect calorimetry.~     Furthermore, we perform a high-fat mixed meal test, in which we collect blood and measure~     substrate oxidation during fasted and postprandial conditions. During the meal tests, extra~     plasma is collected at the start (t=-30) and the end (t=240), of which the supernatant is~     stored in light-protected tubes (EGCG is mixed 1:1 with an EGCG buffer) for analyzing~     polyphenol concentrations in the blood.~      In the male subgroup (21 men), we additionally place each 2 microdialysis probes in the~     subcutaneous adipose tissue and the gastrocnemius in order to assess local lipolysis and~     blood flow by means of ethanol infusion.~      Furthermore, a dexa-scan is performed to assess body composition and biopsies are taken under~     fasted conditions from the subcutaneous adipose tissue and the quadriceps femoralis muscle.~     These samples are stored at -80C. Part of the adipose tissue samples is collected to measure~     adipocyte size. Of the skeletal muscle biopsy, one part is directly buffered and used for the~     oxygraph to measure mitochondrial function.~      At last, feces samples are collected before and after the intervention in order to assess~     energy content, microbial composition and short-chain fatty acid content.~      Based on previous human studies in our and other departments, we hypothesize that after 12~     weeks of the combined polyphenol supplementation, insulin sensitivity and mitochondrial~     function improve. Furthermore, based on results of a short-term study performed by our group,~     that demonstrated an increase in energy expenditure, a positive effect on the regulation of~     body composition might be expected.~   "
90612|NCT02381132|"~     The purpose of this study is to explore the clinical characteristics oral MNK155 and Norco®~     7.5mg/325mg when used for the treatment of moderate to severe post operative pain.~   "
90613|NCT02381119|"~     This study addresses the challenge of increasing compliance with dietary recommendations and~     guidelines among diabetes type 2 patients by introducing professional dietary advice based on~     individual requirements.~      The objective of this study is to assess the effect of the Personalized Dietary Advice~     Services (PDAS) after a three month intervention on established markers of nutritional and~     health status in diabetes type 2 patients (HbA1c, glucose, insulin). Besides, the effect of~     the PDAS on perceived health status of diabetes type 2 patients will be assessed.~   "
90614|NCT02381106|"~     The primary overall objective of this study is to characterize the levels of and compare~     levels of the ADRB3 receptor in human non-pregnant myometrium, pregnant myometrium at~     different time points in pregnancy, in normal and dysfunctional labor and also to measure~     levels and expression of these receptors in placental arteries at different maturation~     statuses of placenta and in pre-eclampsia/hypertension~   "
90615|NCT02381093|"~     The current method of teaching Basic Life Support (BLS) courses involves a practice schedule~     where learners rotate through each station once, without repetition. Laypeople learning~     within this blocked schedule may experience poor skill retention, resulting in suboptimal~     delivery of Cardiopulmonary Resuscitation (CPR). Implementing a Contextual Interference (CI)~     practice scheduling method to BLS training would involve presenting each station multiple~     times within the same timeframe. CI is known to lead to better retention in other domains,~     such as sport and engineering. Our project will test the effect of CI on the long-term~     retention of BLS skills. We hypothesize that participants trained in BLS using CI techniques~     will have superior skill retention at 3 months compared to those trained with the~     conventional BLS course.~   "
90616|NCT02381080|"~     The purpose of this study is to assess the effect of a moderate Cytochrome P450 (CYP) 3A~     inhibitor (erythromycin) and a strong CYP3A inhibitor (voriconazole) on the steady-state~     pharmacokinetics (PK [the study of the way a drug enters and leaves the blood and tissues~     over time]) of repeated oral doses of ibrutinib in participants with B-cell malignancy~     (cancer or other progressively enlarging and spreading tumors).~   "
90617|NCT02381067|"~     The study is intended to demonstrate that the NuCel® allograft is effective and safe in~     promoting bone growth and fusion rate when used in cervical fusion in patients with one, two~     or three-level diseases of the cervical spine.~   "
90618|NCT02381054|"~     The purpose of this study is to see if the Italian language version of a questionnaire about~     symptoms that patients may have during cancer treatment is understandable to Italian speaking~     patients. The questionnaire is called the PRO-CTCAE, and was originally developed at the U.S.~     National Cancer Institute to help get information about patients' symptoms directly from the~     patients themselves. The Italian version of the questionnaire will be used in future studies~     to gain a better understanding of patient symptoms.~   "
90619|NCT02381041|"~     This study aims to compare two vasoconstrictive agents topically applied in cosmetic~     rhinoplasty: cocaine HCl 5% and adrenaline 1:1000. Blood loss during surgery as well as~     systemic effect of the studied agents are evaluated.~   "
90620|NCT02381028|"~     The aim of this small pilot study is to assess the potential effects and risks of applying~     fresh human milk locally on eczema spots in children with atopic eczema. This is a split~     body, controlled, randomized and physician blinded pilot study, of children with atopic~     eczema with two similar contralateral eczema spots having a mother breastfeeding the child or~     a sibling. Fresh expressed milk and emollient is to be applied on the intervention spot and~     emollient alone on the control area, three times a day for four weeks. Severity and area of~     the eczema spots is evaluated weekly, and samples from milk and the spots were analysed~     weekly with respect to bacterial colonisation.~   "
90621|NCT02381015|"~     This study was designed to compare the efficacy, perception, decision making, and~     cost-effectiveness of genomic and non-genomic approaches for risk assessment of prostate~     cancer and for chemoprevention of prostate cancer.~   "
90622|NCT02381002|"~     Background: Obesity is associated with alterations in iron metabolism leading to iron~     deficiency.~      Aim: to study the prevalence of obesity among primary school students, assess iron status~     among overweight/obese children with age ranging between 6 and 12 years and the effect of~     weight reduction program on iron status.~      Patients and Methods: The study will be conducted on 2 groups. Group 1 will include 1025~     primary school children recruited from 2 urban schools in Cairo with age ranging between 6~     and 12. Anthropometric measures and prevalence of overweight/obesity will be assessed. Group~     2 will include 100 obese children according to the CDC definition and 50 age and sex matched~     children with normal weight. All will be subjected to history taking, anthropometric~     measures, complete blood picture, iron profile and soluble transferrin receptor. Weight~     reduction program for 6 months will be done for obese children and all parameters will be~     re-ckecked.~   "
90623|NCT02380989|"~     Sports-related soft tissue injuries, such as sprains, strains, and contusions, are a common~     painful condition. Current treatment includes oral nonsteroidal anti-inflammatory drugs~     (NSAIDs), which have a high incidence of intolerable gastrointestinal side effects.~      Ancient Indian healing system, Ayurveda addresses the need of sports medicine up to certain~     extent. In practice, there are different treatment modalities for injuries, uses of drugs &~     dietetics as well as practices of rehabilitation. Although, previous evidences support the~     efficacy of ayurveda practices with significant reduction in pain, joint tenderness, joint~     swelling, mobility restriction and early morning joint stiffness. But there is no treatment~     studies have been performed to evaluate the clinical outcome for specific sports injuries.~      This study assessed the efficacy and safety of ayurveda gel and patches applied to the~     painful injury site for the treatment of acute minor sports injury pain.~   "
90624|NCT02380976|"~     A randomized, open-label, single-dose, crossover Phase I Study to investigate the relative~     bioavailability of DW340 and DW330SR + DW1030 co-administration in healthy male volunteers.~   "
90625|NCT02380963|"~     Dietary protein is a key element of most effective weight loss regimens. This study will~     investigate the effects of consuming soy protein on body composition and cardiometabolic~     health within the context of an effective weight loss and maintenance program called the~     Colorado Diet.~   "
90626|NCT02380950|"~     Objectives: Alcohol metabolism is changed in gastric bypass patients, leading to faster~     resorption and higher alcohol peak concentrations in blood. Because of stronger alcohol~     effects after gastric bypass we suggest that also general cognitive function is stronger~     impaired.~      Materials and Methods: We included 28 females (12 gastric bypass patients, 8 obese and 8~     normal weight subjects) in the study. Each participant had to drink 250 ml white wine.~     Directly before, 10-30 min after and 45-65 min after wine consumption cognitive functions~     were tested by test battery for attentional performance (TAP) from Zimmermann and Fimm.~     During the whole examination breath-alcohol-contents (BACs) were measured every 5 minutes~     with breathalyser Dräger Alcotest 7510.~   "
90627|NCT02380937|"~     The Radio Frequency Ablation for Atrial Flutter with Magnetic Resonance Guidance and Tracking~     Pilot Study (hereafter referred to as pilot study) is a prospective, non- randomized,~     single-center, pilot study. The purpose of this clinical study is to evaluate the safety and~     performance of the Imricor Medical Systems, Inc. (Imricor) Vision Ablation Catheter when used~     with related accessories for the treatment of type I atrial flutter. The Vision Ablation~     Catheter and its accessories have been designed for use under fluoroscopic or magnetic~     resonance guidance.~   "
90628|NCT02380924|"~     This is a randomized, single-blind, single-center, concurrently controlled, exploratory,~     Phase I study to determine the in vivo kinetics (24-hour post-infusion recovery and T50~     survival) of EryDex System (EDS) -processed autologous red blood cells (RBC) in non-patient~     volunteers. A total of 12 non-patient volunteer subjects will be enrolled and assigned to one~     of the 2 groups (6 subjects in active arm group, 6 subjects in sham arm group).~   "
90629|NCT02380911|"~     Hypercholesterolemia, a major cause of disease burden in both the developed and developing~     world, is estimated to cause 2.6 million deaths annually (4.5% of all deaths) and one third~     of ischemic heart diseases., and result in 29.7 million DALY lost. In Argentina, the~     prevalence of hypercholesterolemia increased between 2005 and 2013 from 27.9% to 29.8%,~     whereas the rate of non-optimal LDL-C, was 28.0%. The rate of high cholesterol awareness was~     37.3 % and the proportion of those who are under pharmacological treatment was dismally low:~     only 11.1%. Furthermore, only one out of four subjects with a self-reported diagnosis of~     coronary heart disease (CHD) is taking statins. and most individuals with CHD who are on~     statins have sub-optimal LDL-C levels. Although other antihypertensive, antidiabetic and~     low-dose aspirin were available free-of-charge at the primary care clinics of the public~     sector, statins had not been included until recently. As of 2014, statins (simvastatin 20mg)~     were incorporated into the package of drugs provided free-of-charge for patients with high~     cholesterol, according to CVD risk stratification. The goal of this study is to test whether~     a multifaceted educational intervention targeting physicians and pharmacist assistants,~     improves detection, treatment and control of hypercholesterolemia among uninsured patients~     with moderate to high cardiovascular risk in Argentina. Specifically, the intervention will~     test whether a multifaceted educational intervention program lowers LDL-cholesterol levels~     and CVD risk in moderate to high cardiovascular risk patients, improves physician compliance~     with clinical practice guidelines, and improves patient care management and adherence to~     medication. A cost-effectiveness study will be conducted to compare the intervention to the~     usual standard of care. This randomized cluster trial will enroll 350 patients from 10 public~     primary care clinics who will be assigned to receive either the intervention or the usual~     care. This study is timely and will generate urgently needed data on effective and, practical~     and sustainable intervention programs aimed at the prevention and control of CVD risk that~     can be directly used in other primary care settings and health care systems in LMICs.~   "
90630|NCT02380898|"~     Our study is planned to investigate if pre-emptive Ketorolac would decrease the incidence of~     intraoperative shoulder tip pain and improve discomfort during Caesarean section.~   "
90631|NCT02380885|"~     The study evaluates the effectiveness of the social cognition and interaction training~     (SCIT), in comparison to both therapeutic alliance focused therapy (TAFT) and treatment as~     usual (TAU) among persons with severe mental illness. Study purpose: 1) Assess the~     effectiveness of the SCIT and TAFT interventions, 2) Assess the processes that putatively~     contribute to the SCIT and TAFT outcomes. Method: A Randomized Controlled Trial (RCT) with~     approximately one hundred and fifty persons with severe mental illness will be carried out in~     different psychiatric rehabilitation units and clinics in Israel. To assess the relative~     effectiveness of the SCIT and TAFT interventions with persons with severe mental illness,~     both interventions will be compared to treatment as usual (TAU). Clinicians will be trained~     in both interventions, and outcome measures, including social quality of life and social~     functioning, as well as mediating processes, including the identification of affective~     states, ToM, attribution errors and therapeutic alliance, will be assessed. Cognitive~     functioning and symptom severity will be treated as covariates. Statistical analyses will~     include analysis of variance which takes into consideration attrition, effect size, mediation~     processes and covariates.~   "
90632|NCT02380872|"~     The main objective of this study was to evaluate the matrix metalloproteinase (MMP)-8, and~     -9, tissue inhibitor of matrix metalloproteinase and interleukin-1beta levels in gingival~     crevicular fluid during the early and late stages of healing for gingival recession sites~     treated by coronally advanced flap plus platelet rich fibrin (PRF) compared to CAF plus~     connective tissue graft. As PRF consists of several growth factors, it may enhance the~     healing potential of soft tissues, the investigators hypothesized that using PRF in the~     treatment of gingival recessions might regulate inflammation and promote wound healing.~   "
90699|NCT02379962|"~     The purpose of this study is to collect date related to public knowledge and attitude towards~     biospecimen-based research and their willingness to participate in biobanking in China.~   "
90633|NCT02380859|"~     Subjects diagnosed with Idiopathic Parkinson's Disease, between ages of 40-85 inclusive, who~     have been referred for gait training. Since there can be subtle differences in the brain~     organization of left- and right-handed people that may influence some of the measurements,~     right handed participants are preferred. However, a left handed participant may be~     considered. Participants will be randomly assigned to one of two groups to undergo two weeks~     of twice-daily sessions. Group A receiving goggles fitted with lenses that distort vision and~     Group B patients receiving sham goggles~   "
90634|NCT02380846|"~     This study aims to find out how consuming different proteins with rice affect metabolism.~     Most meals the investigators eat predominantly consist of a carbohydrate and protein (i.e.~     rice, noodles, bread etc with meats or seafood). However, it is still unknown how consuming~     different proteins with commonly eaten carbohydrates affect metabolism. Previous studies have~     shown that proteins stimulate hormones such as insulin, glucagon and gut hormones. However,~     the extent of the response depends on protein type. The metabolic responses to carbohydrates~     have also been shown to be greatly affected when they are eaten with proteins. However, most~     of the previous studies have used glucose as the carbohydrate and it is still unknown how~     eating proteins with carbohydrate foods such as rice affect metabolism. Therefore, this study~     has been initiated to determine the metabolic effects of eating different protein types with~     rice. Using the most common carbohydrate eaten in Asia (rice) and four commonly eaten protein~     foods (egg, chicken, fish and beancurd), this study aims to observe the metabolic effects of~     co-ingesting proteins and carbohydrate. The resulting data will provide valuable insights~     into the metabolic effects of protein-carbohydrate meals and will be useful in the~     development of practical advice and dietary guidelines for those with chronic diseases (such~     as diabetes and obesity).~   "
90635|NCT02380833|"~     The purpose of this study is to determine the effectiveness of recommending either a~     Paleolithic based diet or the United States Department of Agriculture MyPlate guidelines with~     or without exercise on physical conditioning, hormones related to energy metabolism, body~     composition, resting energy expenditure, blood biomarkers, and urine in young, adult females.~   "
90636|NCT02380820|"~     The main objective of this study is to compare the Softform Premier mattress (in static mode)~     and AIRSOFT DUO mattresses in terms of skin pressures measured at the sacral area.~   "
90637|NCT02380807|"~     This study evaluates the effect of Dry Needling on Spinal Mobility and Trigger Points in~     Patients with Fibromyalgia Syndrome.~   "
90638|NCT02380794|"~     Peripheral arterial disease (PAD) due to lower limb arterial blockages affects significant~     proportion of the population with an age-adjusted prevalence of approximately 12%.~     Claudication induced walking impairment can be debilitating and adversely affects social,~     leisure, and occupational activities in many patients and is associated with higher mortality~     among PAD patients.~      Unfortunately, very few effective therapies are available to improve leg symptoms and~     exercise performance in PAD patients. Surgery is the last resort but results vary. Therefore,~     there is a large unmet need for medical therapies that can improve long-term walking~     performance and functional capacity in PAD patients.~      Danshen and Gegen (D&G) are commonly used Chinese herbal medicine in the treatment of~     cardiovascular diseases. D&G study has been extensively researched and continued at The~     Chinese University of Hong Kong (CUHK) for their antioxidative and vasodilator properties,~     modulate anti-atherosclerosis and improve arthrogenic athophysiology. Three randomized trials~     were completed at the CUHK showing D&G improved lipid profile, vascular function and thinned~     down the internal layer of the carotid artery. One may expect the same with lower limb~     arteries. Extensive clinical experiences of use in China and Hong Kong indicated that D&G are~     well tolerated and safe.~      This project is a randomized control trial to determine the efficacy and Safety of D&G in~     improving the functional capacity & QoL in patients with symptomatic PAD. The results of this~     study have the potential to change local and international practice in providing a much~     needed therapeutic option in the treatment of PAD.~   "
90639|NCT02380781|"~     This is a prospective randomized control trial in which we propose an intervention in the~     immediate post-partum period to educate women about contraceptive options, particularly long~     acting reversible contraception (LARC) methods with an aim of increasing the amount of women~     who choose a LARC method.~   "
90640|NCT02380768|"~     The purpose of this study is to determine whether there is a clinically relevant difference~     in airway leak pressures between the Ambu AuraGain and the Laryngeal Mask Airway (LMA)~     Supreme.~   "
90641|NCT02380755|"~     Hypogonadism is a clinical condition that can be associated with obesity in man. Controversy~     exists regarding if its a condition that needs to be treated. The standard Testosterone~     Therapy is associated with increase in cardiovascular risks, according to some studies, and~     leads to infertility. The use of Clomiphene Citrate in this sub population of obese man as an~     alternative treatment option is not well studied. The aim of this protocol is to evaluate the~     cardiovascular risks, metabolic and hormonal parameters in a double blinded randomized~     placebo trial.~   "
90642|NCT02380742|"~     The purpose of this study is to evaluate if lidocaine-prilocaine (EMLA 5%) cream can reduce~     pain and discomfort at the time of vaginal pessary removal and insertion. Half of the~     participants will receive lidocaine-prilocaine (EMLA 5%) cream and the other half will~     receive a placebo cream.~   "
90643|NCT02380729|"~     The MENDEL-study will investigate whether the use of gene panel or whole genome sequencing~     (WGS) will:~        1. improve the rate of diagnosis and through this compare the performance of the two~          diagnostic approaches (gene panel vs. WGS),~        2. investigate whether use of said sequencing approaches early in the diagnostic process~          results in reduced health care spending, and~        3. result in an improved quality of life for the patients and their parents.~   "
90644|NCT02380703|"~     This study will evaluate whether a home-based targeted education and skill training~     (Aggression Prevention Training or APT) will reduce aggression in persons with dementia (PWD)~     and pain/pain-related features more than usual care plus supportive telephone calls. Half of~     the participants will receive APT and half will receive supportive telephone calls.~   "
90669|NCT02380365|"~     Experimental intervention: electrocardiography. Control intervention: none~      Duration of intervention per patient/subject:~      5 min, observation 6 months~      Key inclusion criteria:~        -  outpatients after lung transplantation (single, double or combined)~        -  outpatients on the wait list for lung transplantation~      Key exclusion criteria:~      • no informed consent~   "
90645|NCT02380690|"~     To maximize implementation potential of pain self-management in the VA, alternative delivery~     methods are needed to provide Veterans with education and support needed to self-manage their~     pain, without requiring additional resources from healthcare teams. A novel and promising~     approach is a peer coaching model, in which Veterans with chronic pain who are successfully~     managing their pain offer information, support, and mentorship to other Veterans with pain.~   "
90646|NCT02380677|"~     A Phase 1/2a, open-label, dose-escalation study with enrollment in Phase 1 to continue until~     determination of the Maximum Tolerated Dose (MTD) /Recommended Phase 2a Dose (RP2D), and then~     enrollment into Phase 2a expansion cohorts will be initiated.~   "
90647|NCT02380664|"~     Swimming training is associated with decreased bone mass and lower bone mass acquisition~     during growth periods, mainly when compared to other weight-bearing sports. Little~     information is available in adolescents pointing in the same direction but still~     controversial.~      On the other hand, bone strength do not only depends on bone mass but on bone structure and~     microarchitecture. The cross sectional area, cortex thickness or trabecular density are~     important aspects of bone health. There are few studies on the effect of swimming on bone~     architecture of adolescents. This information is relevant for present and future health of~     adolescents practicing swimming and for all the organizations promoting this sport. Jumping~     and whole body vibration training programs seem to elicit important osteogenic effects;~     however, there is little information on this regard in adolescent population, even less in~     these adolescents with potentially decreased bone acquisition such as swimmers.~      The main aims of this research project are therefore, to analyze the effect of swimming~     training on bone mass, metabolism, structure and architecture in adolescents analyzing~     possible relationships among them. Secondly, to test whether including short boots of jumping~     or whole body vibration may be able to palliate the possible deleterious effects of swimming~     and facilitate a normal or even healthier bone development. And finally to study the~     durability of training-related bone gains over time.~   "
90648|NCT02380651|"~     This study aims to assess the functional ability and health-related quality of life (HRQoL)~     of upper extremity sarcoma patients who have undergone limb salvage surgery.~   "
90649|NCT02380638|"~     The main aims of the present project include 1) to study the longitudinal effects of~     whole-body vibratory exercise on bone metabolism in adolescents with and without DS and 2) to~     evaluate whether a low frequency vibratory training program consisting of 3 sessions per week~     for 9 months (each vibratory session last approximately 10 minutes and includes 5-6 bouts of~     1 min with 1 min rest between bouts) can improve bone development in these populations.~     Finally, and additional aim of the project is 3) to determine how long these effects may last~     after the end of the intervention.~   "
90650|NCT02380625|"~     The purpose of this study is to determine whether multiple therapeutic regimens are effective~     in the treatment of Ebola Virus Disease (EVD)~   "
90651|NCT02380612|"~     This is a randomized, within-subject controlled study to compare the clinical performance of~     the ReCell device when used as an adjunct to meshed skin graft in subjects requiring skin~     grafts for closure of burn injuries. Co-primary effectiveness endpoints include: (1)~     confirmed treatment area closure (i.e., healing) prior to or at 8 weeks as assessed by a~     blinded evaluator, and (2) a comparison of the actual expansion ratio, computed as the ratio~     of measured treated area to the measured donor site area, achieved for the ReCell-treated and~     control treatment areas. Safety will be evaluated in terms of long-term durability, scar~     outcomes and treatment-related adverse events.~   "
90652|NCT02380599|"~     Spinal mobilization and spinal manipulation are common techniques utilized in the field of~     physical therapy. Despite their common utility, little is known about the physiological~     mechanisms underlying the changes experienced following the interventions. Recent research~     suggests that neurological mechanisms may be involved in the post interventional changes, but~     research supporting this view is still evolving. Therefore, this study will explore whether~     there is a neurophysiological difference between spinal manipulation and spinal mobilization~     techniques. The neurophysiological difference will be measured by monitoring heart rate~     variability, a cardiovagal indicator of autonomic nervous system activity. The primary~     hypotheses of this study are three-fold, first that spinal manipulation will result in a~     change in heart rate variability that is different then sham intervention. Second, spinal~     mobilization will result in a change in heart rate variability that is different then sham~     intervention. Finally, the investigators hypothesize that spinal mobilization and spinal~     manipulation will produce different changes in heart rate variability.~   "
90653|NCT02380586|"~     A national survey of current practices, preferred drug and technique choices for obstetric~     anesthesia and analgesia in Czech Republic and Slovak Republic.~   "
90654|NCT02380573|"~     A double-blind, placebo-controlled study that aims to investigate the effect of 2-week and~     12-week administration of USP methylene blue (MB) on cerebral blood flow, functional~     connectivity, memory and attention cognitive abilities using fMRI and behavioral measures in~     healthy aging, mild cognitive impairment (MCI) and mild Alzheimer's disease (AD) subjects.~   "
90655|NCT02380560|"~     100 women divided into 3 groups:~        -  Group I: included 50 women with preterm premature rupture of membranes (PPROM, n=50)~          with gestational age from 24 to 34 weeks.~        -  Group II: included 25 term non-labor control (T-CTR, n=25) with gestational age from 37~          to 41 weeks.~        -  Group III: included 25 preterm non-labor control (P-CTR, n=25) with gestational age from~          24 to 34 weeks.The myometrial thickness at 4 different sites9:~           a) The lower uterine segment (LUS): 2cm above the reflection of the full urinary bladder~          (b)The anterior wall: 1cm above the maternal umbilicus. (c)Fundus: by placing the scan~          probe perpendicularly above the uterine fundus so that the entire curvature of the~          uterus was visualized.~           (d)The posterior wall: through using the maternal abdominal aortic pulsation as an~          anatomic marker.~      At least 3 measurements were obtained at each site and averaged. The latency interval is~     determined in each of the 3 groups.~   "
90656|NCT02380547|"~     Usefulness of non invasive ventilation in patients extubated after more than 48 hours of~     invasive ventilation is still in debate except for specific patients (chronic pulmonary~     disease and chronic heart failure).~      Many experimental and clinical studies have shown that diaphragmatic function is depressed by~     mechanical ventilation in intubated patients.~      The investigators will test the hypothesis that non invasive ventilation after extubation may~     improve diaphragmatic function~   "
90658|NCT02380521|"~     The glucagon-like peptide 1 (GLP-1) agonist exenatide represents an effective therapy in~     patients with type 2 diabetes mellitus (T2DM), which also seems to have some important~     non-glycemic effects. Yet, these non-glycemic effects are still largely unknown.~      The effect of exenatide once weekly was investigated in controlled, blinded and open-label~     clinical studies in subjects with T2DM who were controlled on diet and exercise alone or in~     combination with oral antidiabetic agents, but also in multi-dose controlled studies and such~     studies resulted in significant reductions in glycemic parameters (mean glycated hemoglobin~     (HbA1c), fasting serum/plasma glucose as well as postprandial plasma glucose levels), but~     also in body weight, over 24 to 30 weeks. Meaningful reductions were observed as early as~     week 4 of treatment, and maintained through 6 years of treatment.~      The study investigating cardiovascular effects of exenatide once weekly is currently~     undergoing. The results available are not numerous (such as DURATION-2, DURATION-3,~     DURATION-4 studies) and cannot lead to definitive conclusions.~      In this study the investigators will evaluate the effect of exenatide once-weekly on multiple~     cardiovascular risk markers. These markers are related to subclinical atherosclerosis,~     endothelial dysfunction, oxidative stress and atherogenic lipoproteins.~      The investigators will perform an open label, single-arm, prospective, intervention study~     using exenatide once weekly for a period of 8 months on 60 patients with T2DM.~   "
90659|NCT02380508|"~     TB038 is a clinical study to assess the non-specific effects of BCG vaccination and gain a~     better understanding of how the body's immune system reacts to BCG and in turn potentially~     prevents infection from other bacteria.~   "
90660|NCT02380495|"~     Studio Nava is a National Study aiming to assess allergic rhinitis and asthma outcomes on~     Quality of Life and Quality of Sleep in adolescent patients by means of Web Survey. Studio~     Nava also proposes the innovative use of a web platform (http://nava.ibim.cnr.it/) that~     contains all standardized tools (medical-healthcare web form, ACT, Asthma control test; PSQI,~     Pittsburgh Sleep Quality Index; T5SS, Total Symptom Score; modified SIDRIA for adolescents;~     Rhinasthma; VAS scale), that will be available for the doctors after the registration to the~     web platform. Downloaded questionnaires will be delivered to case-patient, asking him/her to~     fill them during the waiting time of the visit.~   "
90661|NCT02380482|"~     Traumatic brain injury (TBI) is a frequent pathology leading to major morbidity and mortality~     in young people. Cerebral flood flow maintenance is a major goal directed therapy to improve~     the prognosis of the patient. Due to cerebral-myocardial interaction, a myocardial~     dysfunction might occur at the early phase of the traumatic brain injury. This myocardial~     dysfunction could be partly responsible for a decrease in cerebral blood flow. In such case,~     improving myocardial dysfunction may help to increase cerebral blood flow and improve patient~     prognosis. In clinical practice the easiest and non invasive way to explore myocardial~     dysfunction is with transthoracic echocardiography. The objective of this trial is to~     investigate myocardial dysfunction at the early phase of traumatic brain injury, compared~     with a controlled group without TBI.~   "
90662|NCT02380469|"~     The purpose of this study is to investigate whether a systematic early assessment of~     uncovered needs for information, supplemented by an interview about the needs with the~     patient's nurse who seeks to provide the information requested, will improve the caregivers'~     and the patients' satisfaction with information and communication and potentially also~     decrease anxiety and depression.~   "
90663|NCT02380443|"~     This is a single center, open label dose frequency escalation study of InSituVax personalized~     anti-tumor vaccine protocol combining the cryoablation of a selected metastatic lesion with~     intra-lesional immunotherapy with AlloStim®. The in-situ (in the body) cancer vaccine step~     combines killing a single metastatic tumor lesion by use of cryoablation in order to cause~     the release of tumor-specific markers to the immune system and then injecting bioengineered~     allogeneic immune cells (AlloStim®) into the lesion as an adjuvant in order to modulate the~     immune response and educate the immune system to kill other tumor cells where ever they~     reside in the body.~   "
90664|NCT02380430|"~     In France, there are no precise data regarding perioperative organization of medical~     structure and care management of ambulatory surgical patients. Particularly, data on~     management of pain, nausea and vomiting, as well as venous thromboembolic, prevention and~     treatment are needed, in several groups of patients.~   "
90665|NCT02380417|"~     This is a prospective observational trial of patient undergoing lung transplantation who have~     a thoracic paravertebral catheter(s) placed for postoperative pain control. Patients pain~     scores and opioid use were evaluated for 7 days after placement as well as any complications,~     opioid adverse events, and length of stay.~   "
90666|NCT02380404|"~     1. Hypothesis/Specific aims~      The aim of the present study proposal is to validate an implant treatment concept in the~     edentulous upper maxilla using four implants-supported locators abutments to retain removable~     prosthesis.~      Specific aims:~        -  The primary objective of the study is to evaluate the implant and prosthodontics success~          rates of the proposed implant treatment approach after a follow-up period of 1, 3 and 5~          years as well as the biological and prosthodontics complications.~        -  The secondary objective is to assess the evolution of patient centered outcomes with the~          suggested treatment in the maxilla. Oral health-related quality of life (OHRQoL) and~          patients' satisfaction relating to their prostheses will be considered.~        -  The third objective will be to compare the implant, prosthodontics and patient-centered~          outcomes according to the implant distribution; 4 anterior to maxillary sinus (ANT)~          versus 2 anterior implants and 2 implants in the maxillary tuberosity (POST).~      Hypothesis:~        -  Implant survival rate using this treatment concept is similar to restoration with~          implant-supported fixed prosthesis, based on published data. No difference of implant~          survival rates is found between ANT and POST implant distribution.~        -  Prosthodontics survival rate using the following treatment concept is similar to the~          ones found with a bar, based on published data. The ANT implant distribution causes~          fewer prosthodontics complications compared to the POST implant distribution.~        -  There is a significant improvement in OHRQoL and patient satisfaction compared to the~          baseline OHRQoL observed with a conventional removable denture. The levels of~          improvement OHRQoL and patient satisfaction are similar for ANT and POST implant~          distributions.~   "
90667|NCT02380391|"~     Elevated on-treatment platelet reactivity is an independent risk factor of major adverse~     cardiovascular events following percutaneous coronary intervention or ACS. People living with~     HIV patients have a higher risk of recurrent events after ACS than people without HIV.~      The investigators hypothesized that this increased risk is driven by higher platelet~     reactivity.~      Using a nested case-control study design, HIV-infected and HIV-uninfected patients with a~     first episode of Acute Coronary Syndrome (ACS) treated with percutaneous coronary~     intervention were matched for age, sex, known diabetes mellitus and anti-platelet therapy.~      The primary end-point was the residual platelet reactivity (RPA) on dual antiplatelet therapy~     assessed by light transmission aggregometry (LTA, 20µM ADP).~      The study was conducted in a two large public university hospitals in central Paris, France.~   "
90700|NCT02379949|"~     This randomized clinical trial compares virtual reality exposure therapy to exposure group~     therapy to a waiting list control group.~   "
90671|NCT02380339|"~     Uncontrolled diabetes is associated with increased risk for micro-vascular complication.~     Hypoglycemia is one of the major barriers in achieving good glucose control. Hypoglycemia is~     associated with a range of unpleasant symptoms including palpitations, tremor, hunger,~     sweating, confusion, difficulties in thinking as well as other idiosyncratic symptoms. Fear~     of hypoglycemia (FOH) refers to phobic avoidance reactions associated with hypoglycemia FOH~     may increase behavioral attempts to avoid hypoglycemia including decreased consumption of~     insulin and/or increased consumption of carbohydrates, resulting in poor glycemic control and~     an increased risk of diabetic complication. In this study, the investigators present a novel~     system, which simultaneously employs BioFeedback and Virtual Reality in order to cope with~     fear of hypoglycemia.~   "
90672|NCT02380326|"~     Evaluating an integrated diagnostic work-up of virtual navigation bronchoscopy (VNB),~     confocal laser endomicroscopy and micro computerized tomography (micro-CT) in the diagnostic~     path of pulmonary lesions in the non-oncological patient.~   "
90673|NCT02380313|"~     This study is being conducted to characterize the safety and recommended phase 2 dose (RP2D)~     of combining afuresertib, independently with 2 approved drugs: enzalutamide (Xtandi®, Xtandi~     is a trademark of Astellas Pharma, Inc. ) and abiraterone (Zygita®, Zytiga is a trademark~     of Janssen Biotech, Inc.). The study will be conducted in two parts. Part 1, a dose~     escalation phase, will establish RP2D of afuresertib when administered with enzalutamide or~     abiraterone. Part 2, a dose expansion phase, will further evaluate long-term safety of the~     combinations at the RP2Ds in additional subjects. Dose-finding cohorts will be studied in~     parallel and will evaluate safety and pharmacokinetic to guide selection of the dose regimens~     for further evaluation. Part 2 will begin once the RP2Ds have been established in Part 1.~     Additional doses and/or schedules may be explored if warranted, based upon the~     pharmacokinetic (PK) and pharmacodynamic (PD) assessments or emerging preclinical evidence.~     Overall, approximately 60 chemotherapy-naïve subjects with mCRPC and who are receiving either~     enzalutamide or abiraterone will be enrolled into the study.~   "
90674|NCT02380300|"~     The purpose of this study is to clear the Safety and Necessity of the Magnetic Resonance~     Imaging (MRI) in the Presence of CIEDs(Cardiovascular Implantable Electronic Devices).~   "
90675|NCT02380287|"~     This is an open label, phase 1, 3+3 dose escalating study of tolerability, safety,~     pharmacokinetics and immunogenicity of a single subcutaneous injection of the novel~     monoclonal antibody against human IL-17 - BCD-085. The study will enroll 37 healthy male~     volunteers.~   "
90676|NCT02380274|"~     The purpose of this study is to describe patterns of care in CRPC patients, as well as~     health-related quality of life (HRQoL) outcomes associated with CRPC and its management.~      This study will also describe factors influencing treatment decisions including reason(s) for~     treatment choices and triggers for treatment changes for CRPC as well as describe clinical~     outcomes based on patient characteristics.~   "
90677|NCT02380261|"~     The purpose of this study is to verify the skin and ocular tolerance of the product Systane®~     Lid Wipes.~   "
90678|NCT02380248|"~     The purpose of this study is to evaluate the efficacy and safety of Systane® Gel Drops in dry~     eye subjects following 90 days of QID (4 times/day) dosing.~   "
90679|NCT02380235|"~     This study evaluates the safety and efficiency of Pegylated Somatropin (PEG Somatropin)~     Injection in the treatment of endogenous growth hormone deficiency (GHD) in the broad of~     population of children.~   "
90680|NCT02380222|"~     The purpose of this study is to explore the key symptoms of individuals with systemic~     mastocytosis. Interviews of enrolled individuals will be conducted to learn about the disease~     symptoms and condition. The interview will last approximately 60 minutes and will be~     conducted by a trained interviewer, be audio-recorded (with patient consent), and all~     information provided by the patient will be treated confidentially and made anonymous so that~     it is non-identifiable. The interview may be conducted face-to-face, over the phone, or~     virtually via Skype, a free video conferencing program, depending upon the patient's~     geographic location. Patients will be compensated for their participating time.~      This is not a medication-related study, and no medication will be distributed or tested~     during this study. Participation in this study will not affect any treatment or assistance~     that a patient currently receives or may receive in the future.~   "
90681|NCT02380209|"~     Evaluate the feasibility of translating preclinical Chemical Exchange Saturation Transfer~     (CEST) MRI protocol designed to estimate tumor extracellular pH (pHe) to a clinical MRI~     scanner in women with early stage breast cancer. Assays are used to quantify tumor acidosis.~   "
90682|NCT02380196|"~     The primary objective of this study is to determine whether circulating tumor cells (CTCs)~     can be used as a non-invasive means of confirming pathologic diagnosis in early-stage (Stage~     I) non-small cell lung cancer (NSCLC). Patients scheduled to undergo surgical intervention~     will have blood samples obtained to test for CTCs. Presence of CTCs will be compared to final~     pathologic diagnosis based on surgical specimens to assess the sensitivity of using CTCs~     alone to make a definitive diagnosis.~   "
90683|NCT02380183|"~     This is an openly randomized controlled parallel group study evaluating the effectiveness of~     using a guided approach and free-hand approach in performing upper extremity regional blocks.~     Potential subjects for this study are the patients who are scheduled for upper extremity~     surgeries requiring supraclavicular and interscalene brachial plexus blocks at Montefiore~     Medical Center.~      Rotating residents who are participating in the study will be randomly assigned either to~     perform block under guided approach (with the help of needle guidance) or free-hand without~     the needle guidance. All the blocks will be single injection blocks utilizing the in-plane~     technique for needle insertion which is the usual protocol in our institution. Each resident~     will be performing one interscalene block with the device and one without the device and one~     supraclavicular block with device and one without the device. An independent observer will be~     present during the case and will be responsible for recording the time taken to perform the~     block, number of times the needle has been redirected and the number of times the needle is~     reinserted. This observer will also administer the satisfaction questionnaire. Number of time~     needle is redirected and number of times reinserted is also a self reported assessment by the~     physician who is performing the block. Efficacy of the block will be assessed by the standard~     of care practiced at our center.~   "
90685|NCT02380157|"~     Project titel: Oral potassium supplementation in healthy men - interactions with the~     renin-angiotensin-aldosterone system and the sympathetic nervous system Protocol number:~     KARAASS-1 EudraCT number: 2013-004460-66~      Introduction The global burden of hypertension is huge. This project focuses on the role of~     potassium in human blood pressure regulation. A potassium rich diet lowers blood pressure and~     some studies have shown an increase in blood pressure during potassium depletion. Thus an~     inverse correlation between potassium intake and blood pressure exists. In this trial the~     objective is to test how an oral potassium supplementation, administered in form of the drug~     Kaleorid®, interacts with the renin-angiotensin-aldosterone system and the sympathetic~     nervous system.~      Methods This is a randomized clinical placebo-controlled double-blinded crossover trial. A~     group of healthy men will be randomized to either 4 weeks treatment with the drug Kaleorid®,~     750mg, 3 tablets 3 times daily or to 4 weeks treatment with placebo.~      On day 26 in the first treatment period the participants meet at the hospital to start a~     24-hours ambulatory blood pressure and collect a 48-hours urine sample. The same day a blood~     sample, an electrocardiogram (ECG) and a fat biopsy from the gluteal region will be done. The~     fat biopsy is expected to contain resistance vessels, which are to be investigated further in~     the laboratory.~      On day 28 in the first treatment period the participants meet at the hospital again and are~     tested with an intravenous Angiotensin II infusion followed by continuous measurement of~     blood pressure and the following aldosterone response (using blood samples). Blood pressure~     will be measured with Finger Plethysmography and vascular tonus will be evaluated with the~     use of Impedance Cardiography, Finger Plethysmography and Doppler Ultrasound measurements of~     blood flow before, during and after the Angiotensin II infusion.~      After this first period of treatment and testing a washout period of two weeks is inserted.~     After washout, the participants crossover and starts the second treatment period.~      Feasibility All necessary authorities have approved the trial and all cooperation is~     established.~   "
90686|NCT02380144|"~     The study was designed as a randomized 2-way cross-over study to assess the bioavailability~     of carotenoids and flavonoids from sweet oranges and orange juice. Volunteers followed a~     wash-out period for 2 weeks prior to eating either 400 g of fresh oranges or 719 g of orange~     juice. The amount of test food was adjusted to deliver an equal amount of β-cryptoxanthin~     (740 µg). After a consecutive wash-out period of 2 weeks, the procedure was repeated and the~     volunteers ingested the complementary test food. Blood samples were collected at 8 time~     points up to 9.5 h after test meal consumption. Additionally, 24 h-urine was collected to~     evaluate flavonoid recovery.~   "
90687|NCT02380131|"~     Stage I：preoperative therapy~        -  Capecitabine plus oxaliplatin with herceptin is superior to surgery alone for patients~          with potentially resectable HER-2 positive gastric cancer with liver metastasis; Stage~          II: Perioperative therapy~        -  Perioperative Capecitabine plus oxaliplatin with herceptin is superior to adjuvant~          Capecitabine plus oxaliplatin alone for patients with potentially resectable HER-2~          positive gastric cancer with liver metastasis;~   "
90688|NCT02380118|"~     The purpose of this study is to determine whether IM olanzapine is safer (fewer adverse~     events) and more effective (shorter time to sedation) than conventional haloperidol or~     midazolam when used in the management of acute agitation in the emergency.~   "
90689|NCT02380105|"~     This study aims to evaluate the effectiveness of counseling on pain, function and well-fare~     outcomes for the management of patients with temporomandibular disorder (TMD).~   "
90690|NCT02380092|"~     LEGION™ Primary Total Knee System is CE-marked and marketed in all study regions. This study~     serves as post-market surveillance for LEGION™ Primary Total Knee System with the VERILAST™~     bearing surface (OXINIUM™ femoral component with highly cross-linked polyethylene tibial~     insert).~      All study subjects will receive a LEGION™ Primary Total Knee System with VERILAST™ bearing~     surface and the results will be analysed against historical data from patients who received a~     Genesis II knee replacement.~   "
90691|NCT02380079|"~     The purpose of this study is to determine the safety and clinical effects of SCD-101 when~     given to adults with sickle cell disease.~   "
90692|NCT02380066|"~     The purpose of this study is to determine whether Anyu Peibo Capsule in different doses are~     effective in the treatment of Depression.~      And to explore the preliminary information of safety and efficacy of Anyu Peibo Capsule in~     the Chinese Patients with Depression.~   "
90693|NCT02380053|"~     What are the differential effects of beta-blockers on lung and heart function during exercise~     in chronic obstructive pulmonary disease (COPD)? COPD is a major cause of illness and death.~     Not only do these individuals suffer from lung disease, but COPD often leads to other~     illnesses, particularly heart disease. Beta-blockers very successfully treat heart disease.~     It is therefore logical that one would want to use this treatment in COPD patients with heart~     disease too. However, there has always been concern that beta-blockers could cause~     significant problems in COPD by worsening lung function, as these can have the opposite~     effect to inhalers used to treat COPD that open up airways. Pointedly, there is increasing~     evidence that despite this problem, COPD patients who have been prescribed beta-blockers have~     been shown to gain benefit particularly in terms of preventing death.~      In this study, the investigators therefore want to examine which beta-blocker might be the~     safest for COPD patients, as each work slightly differently. Some beta-blockers may have a~     more beneficial effect on airways than others, whilst still benefitting the heart. The~     investigators will study two different beta-blockers; one that potentially narrows airways~     and one that potentially opens airways. The investigators will be using cardiopulmonary~     exercise testing (an exercise bike that measures both heart and lung function during~     exercise) to look for differences between both beta-blockers primarily in terms of lung~     function but also with information about the heart. The investigators will recruit people~     with moderate to severe COPD who are able to complete a cycle exercise test through their~     respiratory research department. The study will last for 10-12 weeks with 5 main visits to~     the department for serial exercise tests, breathing tests, simple heart function tests and~     simple blood tests that will tell the investigators what other effects these beta-blockers~     are having on the heart and lungs.~   "
90694|NCT02380040|"~     Photoplethismography will be measured and compared in newborns suffering from patent ductus~     arteriosus and normal controls.~   "
90695|NCT02380027|"~     This evaluates the detection rates of prostate cancer by MRI-targeted prostate biopsy~     compared to standard 12-core trans-rectal ultrasound guided (TRUS) prostate biopsy. Each~     participant will be randomly allocated to one of the biopsy tests.~      We hypothesise that MRI-targeted biopsy will detect no fewer clinically significant cancers~     than TRUS biopsy but will detect fewer clinically insignificant prostate cancers than TRUS~     biopsy.~   "
90696|NCT02380001|"~     The purpose of the present investigation is to evaluate the effectiveness of the preoperative~     administration of Dexketoprofen Trometamol, employing the third molar surgery model, when~     compared to postoperative administration of the same drug. It was hypothesized that~     preoperative oral Dexketoprofen trometamol will reduce the intensity of pain by 30% after 8~     hours of the surgery, when compared with post-operative administration.~   "
90697|NCT02379988|"~     This is a pilot study to determine whether the addition of inspiratory hold (breath holding)~     can decrease the radiation dose that the heart and lung receive for patients being treated~     for left sided breast cancer.~   "
90698|NCT02379975|"~     Some clinical and epidemiological studies have revealed a high prevalence of periodontitis~     and tooth loss in patients with rheumatoid arthritis. The aim of this study was to evaluate~     the efficacy of periodontal scaling and oral hygiene instruction for patients with mild~     chronic periodontitis and rheumatoid arthritis through clinical periodontal parameters and~     laboratory tests for CRP (C- reactive protein) and ESR (erythrocyte sedimentation rate).~   "
90701|NCT02379936|"~     The immediate newborn period is the period of highest morbidity in life. Early signs of~     serious disease are often vague and difficult to interpret for the non- specialist. Screening~     lists of clinical signs are useful but have unsatisfactory specificity or sensitivity, cover~     only one or two diseases, and are complicated to handle in low resource settings.~      In critically ill newborns, organ failure to one or multiple organ systems is frequently seen~     due to inadequate circulation to the tissues. Critical disease will cause hypoxia ischemia of~     the cells in the affected organs followed by energy deficiency. Independently of the~     condition causing the energy deficiency this will start a series of events, which initially~     cause a leaking cell membrane leading to that intracellular components, i.e. the enzyme~     Lactate dehydrogenase (LDH), will leak out into the blood. Previous research in newborns~     suggests that LDH is a clinically interesting early predictor of serious illness and may thus~     serve as an important complement to the clinical examination. If the LDH level is elevated~     the health care personnel will realize that something is wrong and call for appropriate~     measures.~      Today LDH analysis is performed at the Dept. of Clinical Chemistry with an inexpensive and~     accurate method. However, this method needs relatively large blood volumes and the delay~     between blood sampling and results is rather long, often several hours. In addition LDH is~     sensitive to hemolysis, which is quite common in blood sampling in newborns. When this is~     detected at the laboratory a new sample will be needed, thus delaying the result even more.~     Also, smaller health care facilities rarely have the laboratory equipment needed for the~     analysis of LDH.~      The Swedish company Calmark Sweden AB is now launching a point-of-care technology for LDH~     analysis called Hilda Neo. LDH is analyzed on an easy-to-use consumable test card together~     with an App on an ordinary smartphone (in the planned study, iPhone 4S). The result is~     presented within minutes and presence of hemolysis will be simultaneously detected on the~     device.~      The investigators speculate that the use of such a LDH test could serve as a diagnostic help~     for health-care staff in Vietnam in making the decision when to send a potentially sick~     newborn to a higher level neonatal unit (in this case the NICU at NPH, Hanoi)~   "
90702|NCT02379923|"~     The primary objective of this trial is to evaluate confirmation of placement of any guidewire~     beyond the chronic total occlusion (CTO) in the true vessel lumen in patients in which at~     least one Asahi series of guidewires and/or Corsair microcatheter were used.~      Procedure success will be defined as angiographic visualization of any guidewire in a~     position either distal or proximal to the occlusion depending on the route of access and the~     absence of in-hospital MACE incorporating the MI Task Force Third Universal Definition of~     Myocardial Infarction.~   "
90703|NCT02379910|"~     This is a study of safety, tolerability, pharmacokinetics and pharmacodynamics of~     AM1030-CREAM in patients with Atopic Dermatitis.~   "
90704|NCT02379897|"~     Controversy exists about the role of dietary glycemic index (GI) and fat content and~     cardiovascular risk. Our aim was to assess the long term effects of altering dietary GI,~     carbohydrate, and fat on body weight, lipids, glucose homeostasis, and C reactive protein~     (CRP) in overweight and obese subjects. Men and post-menopausal women with body mass index~     values between 28-38 kg/m2 were placed on an isoweight average American diet for 5 weeks,~     then randomized to one of 4 diets which differed in GI, carbohydrate and fat content with~     calorie restriction for 12 weeks. The same diets were continued for 5 weeks under isoweight~     conditions, and in the free-living state for 48 weeks.~   "
90705|NCT02379884|"~     This is a prospective observational study evaluating all patients requiring mechanical~     ventilation. Data will be gathered regarding the events prior to ventilation and the~     indication for mechanical ventilation. In-hospital and post-admission outcome will be~     monitored.~   "
90706|NCT02379871|"~     The topic of spinal manipulation (SM) has been a source of increasing research over the past~     decade. Research has focused primarily upon the functional and clinical outcomes associated~     with SM. The physiological mechanisms underlying the clinical changes experienced following~     SM are still largely unknown. Current thought suggests that SM may have an effect upon the~     neurophysiological system, specifically the autonomic nervous system. The purpose of this~     study will be to explore the effects of SM upon the autonomically regulated cardiovagal~     response.~   "
90707|NCT02379858|"~     The purpose of this study is to determine whether Alvimopan (Entereg) in ventral hernia~     surgery patients is associated with accelerated gastrointestinal recovery and reduced length~     of hospital stay compared to placebo controls.~   "
90708|NCT02379845|"~     RATIONALE: Radiation therapy given before surgery of soft tissue sarcoma decreases the size~     of the tumor mass and the presence of malignant cells in its peripheral region. NBTXR3 and~     radiation therapy may kill more cancer cells and increase the tumor shrinkage rendering~     surgery more feasible or easier and achieve better local control of the tumor.~      PURPOSE: This phase II/III is a prospective randomized, multi-center, open-label and active~     controlled two arms study in patients with locally advanced soft tissue sarcoma (STS) of the~     extremity and trunk wall. Patients will be randomized to receive either NBTXR3 as intratumor~     injection, activated by external beam radiation therapy or external beam radiation therapy~     alone, as preoperative treatment. Once the radiotherapy treatment is completed, tumor surgery~     will be performed in all patients.~   "
90709|NCT02379832|"~     Preeclampsia may have several causes leading to different characteristics of the pathology.~     Differentiation between the type of preeclampsia would help to treat patients more~     accurately. This project aims to identify early markers that are specific to each type of~     preeclampsia (early or late, with or without growth restriction). Through a case-control~     study, many data will be collected prospectively (serum markers, ultrasonographic markers,~     maternal factors) among nulliparous women with no sign of preeclampsia (as soon as the first~     trimester) and nulliparous women with preeclampsia (at diagnosis).~   "
90710|NCT02379819|"~     This study evaluates the long term safety and effectiveness of the Nucleus Hybrid L24 Implant~     in a group of newly implanted adults.~   "
90723|NCT02379650|"~     Recurrent pregnancy loss (RPL) affects 5% of couples trying to achieve parenthood. Most cases~     of RPL are unexplained and have no effective treatment to improve the likelihood of a~     pregnancy resulting in a live birth. This leads to significant patient and provider~     frustration and emotional stress. Hydroxychloroquine (HCQ) is a medication commonly used in~     pregnancy to treat autoimmune and connective tissue diseases such as systemic lupus~     erythematosus (SLE). This use has shown that HCQ is very safe in pregnancy. HCQ has~     anti-inflammatory and anti-thrombotic effects and thus may improve pregnancy outcomes in~     couples with unexplained RPL. Although some providers are already prescribing HCQ for~     unexplained RPL, a randomized controlled trial is necessary to determine the true efficacy~     and safety of this treatment. This study has the potential to establish support for a new~     treatment option for unexplained RPL.~   "
90724|NCT02379637|"~     This study is designed to improve knowledge regarding the initial effectiveness of~     N-acetylcysteine (NAC) on cold and cough symptoms.~   "
90711|NCT02379806|"~     Venous thromboembolism (VTE) is a frequent condition, affecting 1.8 per 1,000 people every~     year. Admission to hospital is one of the main risk factors for VTE, and could account for up~     to 20% of all VTE, making VTE prevention in admitted patients an appealing option to reduce~     VTE global burden.~      The landmark MEDENOX trial and others demonstrated the efficacy of low molecular weight~     heparins (LMWH) in reducing a composite outcome of symptomatic and asymptomatic events, the~     latter accounting for the vast majority of events.~      Publication of these trials led to the implementation of thromboprophylaxis policies in~     hospitals, which acceptance has been variable. More recently, the use of thromboprophylaxis~     has been challenged after the publication of 1) a negative trial that used 'death from any~     cause' as main outcome, 2) a systematic review showing the lack of a clear efficacy on the~     risk of pulmonary embolism or death, 3) negative trials using new oral anticoagulants, 4) the~     last version of the American College of Chest Physicians Guidelines, focusing on symptomatic~     events only, downgraded its recommendation for thromboprophylaxis in medical patients to a 1B~     recommendation, restricting its use to patients 'at increased risk of thrombosis' and~     recommending against the use of thromboprophylaxis in patients at low risk of thrombosis,~     patients bleeding or at high risk of bleeding.~      However, a limitation of this interpretation of the data is that in most trials, patients~     with screened asymptomatic events were treated with anticoagulants, preventing the occurrence~     of symptomatic events during follow-up. Moreover, subgroup analyses showed that elderly~     patients were at high risk of thrombosis in these trials, and that LMWH could be particularly~     efficient in this subgroup of patients. Conversely, their risk of bleeding is also higher~     than in younger patients and the current trials were not powered to detect a difference in~     the bleeding risk between groups. Finally, the diagnostic and therapeutic management of VTE~     is more challenging in the elderly. Therefore, we planned a randomized controlled trial on~     the efficacy of LMWH for the prevention of symptomatic VTE in elderly patients.~   "
90712|NCT02379793|"~     The purpose of the study is to investigate skin irritation of LEO 80185 gel, gel vehicle and~     Liquid Paraffin in healthy Japanese male subjects.~   "
90713|NCT02379780|"~     The investigators aimed to compare the effects of perioperative anesthesia consumption of~     ultrasound guided subcostal transversus abdominis plane and paravertebral block in~     laparoscopic cholecystectomy.~   "
90714|NCT02379767|"~     This study aims at evaluating the effect of electroconvulsive therapy in treatment-resistant~     depressed patients on the major serotonin degrading enzyme in the human brain using~     neuroimaging methods, the monoamine oxidase A. Electroconvulsive therapy is an effective~     treatment option in severe cases of depression. However, the mechanisms underlying its effect~     remain uncertain, though variations within the serotonergic neurotransmitter system seem to~     be crucially involved.~   "
90715|NCT02379754|"~     The purpose of the study is to determine whether vestibular and postural compensation~     following schwannoma surgery is improved by ablating remaining vestibular function prior to~     surgery, through gentamicin injections in the middle ear.~   "
90716|NCT02379741|"~     The purpose of this study is to determine whether ADC-1013 (an agonistic human monoclonal~     IgG1 anti-CD40 antibody) is safe and tolerable when administered intratumorally (as repeated~     injections directly into the tumor tissue) or intravenously (as repeated doses directly into~     a vein) in patients with advanced solid tumors.~   "
90717|NCT02379728|"~     Every day in Ghana, 47 babies are stillborn (SB) and 232 babies are born with low~     birth-weight (LBW) - many of whom will die in infancy or suffer lifelong consequences.~      Sleeping on the back during pregnancy has recently emerged in scientific literature as a~     potential risk factor for SB and LBW. In fact, one of the earliest studies to demonstrate~     this link was conducted in Ghana by investigators on this protocol.~      When a woman in mid-to-late-pregnancy lies on her back, her large uterus compresses one of~     the major veins that delivers blood back to her heart and may completely obstruct it. This~     may result in less blood being returned to her heart and less blood being pumped to her~     developing fetus. Such changes may negatively impact the growth of her fetus and, along with~     some other risk factors, may contribute to the death of her baby.~      The investigators have developed a device, 'PrenaBelt', to significantly reduce the amount of~     time a pregnant woman spends sleeping on her back. The PrenaBelt functions via a simple,~     safe, effective, and well-established modality called positional therapy.~      The purpose of this study is to determine the effect of the PrenaBelt on birth-weight and~     assess the feasibility of introducing it to Ghanaian third-trimester pregnant women in their~     home setting via an antenatal care clinic and local health-care staff. Data from this study~     will be used in effect size calculations for the design of a large-scale, epidemiological~     study targeted at reducing LBW and SB in Ghana and globally.~   "
90718|NCT02379715|"~     Desflurane is a halogenated ether with low solubility, giving rapid induction and emergence~     from anesthesia This character is suitable for Volatile Induction and Maintenance Anesthesia~     (VIMA). But desflurane can cause airway irritation when it used as a sole induction agent to~     adult or children, so there were many studies about reducing the airway reflex combined with~     desflurane.~      Remifentanil is a short acting opioid and is quickly hydrolyzed by nonspecific esterase in~     the plasma and multiorgan. Several studies suggest the optimal dose of remifentanil for~     reducing airway reflex or cardiovascular response for intubation combined with desflurane.~     But these studies were under 1 Minimal Alveolar Concentration (MAC) of desflurane and this~     point could be a limitation because desflurane concentration over 1 MAC increase airway~     irritation significantly. This study this study was designed to determine a median effective~     effect-site concentration (EC50) of remifentanil to prevent airway irritation during~     desflurane anesthesia over 1 MAC.~   "
90719|NCT02379702|"~     Following the first study conducted to investigate the prevalence of metabolic syndrome and~     its components in Turkey, it was aimed to demonstrate the change in general health condition~     of available patients after the period of time lapsed. This study will provide important~     information on the social and economic dimensions of metabolic syndrome and will contribute~     to development of preventive programs.~   "
90720|NCT02379689|"~     Dr. Parker (the Investigator) and Semmes Murphey Foundation (Foundation) are conducting a~     study of outcomes and safety associated with degenerative discs at Semmes-Murphey Clinic,~     P.C. (Semmes-Murphey). This study will look at a product that is derived from human tissue,~     that will be injected into the affected disc. With this study, the investigators hope to find~     a safe and effective way to treat degenerative disc disease.~   "
90721|NCT02379676|"~     The purpose of this study is to compare the effects of ticagrelor and clopidogrel on~     endothelial dysfunction and vascular inflammation~      Ticagrelor will lead to beneficial pleiotropic effects compared with treatment with~     clopidogrel in patients receiving a drug-eluting stents (DES) during percutaneous coronary~     intervention (PCI) for non-ST-segment acute coronary syndrome (NSTE-ACS) beyond 1 month after~     the index event. Ticagrelor treatment will improve percent flow-mediated dilation (FMD)~     values and reduces inflammatory gene expression on peripheral blood mononuclear cells.~   "
90722|NCT02379663|"~     This prospective study compares an oral direct factor Xa inhibitor with LMWH for~     thromboprophylaxis in the patients undergoing THA.~   "
90725|NCT02379624|"~     Acute lower gastrointestinal dysfunction is a kind of much common complication which occurred~     in critically ill patients. Once it developed, enteral nutrition would be disturbed. In this~     study, investigators suppose that early application of a sufficient amount of pectin ahead of~     enteral nutrition, may promote recovery of acute lower gastrointestinal dysfunction in~     critically ill patients, and exert its good effect on early EN support.~      Investigators designed this prospective randomized controlled trial to test and evaluates the~     effect whether EN feeding with or without a pectin start would be safe or with advanced~     clinical outcomes.~   "
90726|NCT02379611|"~     Hypothesis At 12 months of age, the neurologic development of TVA of a non cochlear implanted~     profound congenital deaf infant would be different to the development of a normally hearing~     infant.~      At 24 months of age, the neurologic development of TVA of deaf infant implanted before the~     age of 18 months would be similar to the development of a normally hearing infant.~      Main aim The main aim of the research is to study, by means of functional near infrared~     spectroscopy (fNIRS), the neurologic development of the TVA at 24 months of age (+/- 1 month)~     in a group (n=40) of normally hearing infant and in a group (n=40) of profound congenital~     deaf children implanted before the age of 18 months.~      Main outcome Measure and localization of an increase of brain blood flow during an auditory~     stimulation voice type compared to a stimulation non-voice type. Comparison of the~     results between groups at 24 months of age +/- 1 month allows to analyse eventual~     differences.~      Secondary aims and outcomes To study by means of functional near infrared spectroscopy the~     neurologic development of the temporal voice area at 12 months of age (+/- 1 month) in a~     group of normally hearing infant and in a group of profound congenital deaf infant wearing a~     standard hearing device between the age of 11 and 13 months and who will receive a cochlear~     implant between 12 and 18 months of age.~      To study the association between fNIRS data and clinical data of the evaluation of~     comprehension of the spoken language at 24 months of age.~      Methods Two groups of 40 infants matching in age will be constituted. Less than 13 months old~     children will be included during a medical consultation in the ENT department of Necker~     hospital after complete information of both parents. Written consent of both parents will be~     required. An audiophonological checking will be done.~      Then a fNIRS examination will be programmed at the maternity of the Robert Debré hospital and~     done at the age of 12 months (+/- 1 month) and 24 months (+/-1 month). This fNIRS examination~     measures the modifications in brain blood flow during the listening of human voice sound and~     environmental sound.~   "
90727|NCT02379598|"~     Cow's milk allergy is an immunologically mediated adverse reaction to milk proteins. In~     industrialized countries there is an incidence of 2-3% in children younger than 2 years.~     Cow's milk allergy may present with different clinical pictures and symptoms often~     nonspecific. Among the most common are certainly food refusal and failure to thrive until~     frameworks frank malnutrition. It was also noted that the cow's milk allergy can have a~     negative impact on the quality of life of the patient and his family.~      The treatment of this condition provides the setting of a diet that is free of the allergen~     to the base of the adverse reaction.~      There are some types of formulas for the treatment of this condition. The formulas based on~     amino acids are currently used in all cases non-responsive to treatment with the above~     formulas or in all those characterized by severe allergic reactions. Being made from amino~     acids such formulas are by definition non-allergenic. They have also proven to ensure a rapid~     resolution of symptoms favoring a resumption of growth, nutritional status, as well as lead~     to a rapid improvement in the quality of life of the patient and his family. However, the~     studies currently available to us concerning the effects of nutritional formulas based on~     amino acids affect short observation periods (usually less than 6 months) and were directed~     to a comparison only with hydrolysates of whey protein or casein and not with healthy~     subjects. To date thus lack consistent data on the nutritional effects in the medium to long~     term.~   "
90728|NCT02379585|"~     This study is to see how safe the use of short-term fasting is in breast cancer patients who~     will receive chemotherapy before undergoing surgery and to examine if the use of short-term~     fasting will decrease the side effects of chemotherapy and how much a tumor shrinks while~     receiving chemotherapy.~   "
90729|NCT02379572|"~     Standard treatment of glioblastomas (GBMs) consists of microsurgical resection followed by~     concomitant chemoradiation. The extent of resection is one of the most important prognostic~     factors with significant influence on the survival of patients. State of the art technique to~     achieve the most radical resection possible in conventional surgery is fluorescence-guidance~     with 5-aminolevulinic acid (5-ALA). If available, intraoperative MRI (iMRI)-guided tumor~     resection enables an intraoperative resection control and subsequent continuation of surgery~     if contrast enhancing tumor remnants are found. Therefore a more radical resection and longer~     survival of patients might be possible. To date no comparison of these two leading~     technologies for GBM-surgery is available to identify the best surgical therapy of this fatal~     disease and to justify significant healthcare-economic differences between both technologies.~      Goal of this study is to assess the value of iMRI guidance in the resection of GBMs in~     comparison to conventional 5-ALA microsurgery. Primary endpoint is the number of total~     resections (no residual contrast enhancement) in the postoperative MRI (T1+CM within 48 hours~     after surgery) in each group. Secondary endpoints are perioperative clinical data,~     progression free survival, patients' clinical condition and overall survival.~      The study design was chosen to be a parallel-group approach to compare iMRI and 5-ALA centers~     (n=13) to exclude possible bias which might be found by randomizing patients within~     individual iMRI centers and to have surgeons with the most experience possible in use of each~     respective technology.~   "
90730|NCT02379559|"~     The main purpose of this study is to examine the feasibility of an exercise intervention on~     metabolic syndrome (MetS) components and biomarkers related to prostate cancer in Black men~     with MetS who are at increased risk of prostate cancer.~   "
90731|NCT02379546|"~     This study was designed to determine the effect of the depth of anesthesia on the~     oculocardiac reflex (OCR) during pediatric strabismus surgery.~   "
90732|NCT02379533|"~     Patients will be randomly assigned to perform the training program in center or home-based .~     The training program will be conducted in accordance with the recommendations of the American~     College of Sports Medicine. All training sessions will be preceded by stretching of large~     muscle groups and heating (5 minutes) and at the end by cool down and stretching (5 minutes).~     The program will consist of 24 weeks with three sessions per week on alternate days. The~     aerobic training will be continuous, with an increment of 10 minutes in duration every 4~     weeks. The intensity will be prescribed according to ventilatory threshold, characterized by~     the highest intensity of physical exertion fully maintained by aerobic energy pathways. The~     intensity control was done by means of the heart rate value obtained at ventilatory~     threshold.~      Both groups receive the same intervention. However, a group exercise held in the center on a~     treadmill with the direct supervision of a physical education teacher. The other group will~     exercise at home with telephone follow-up weekly and once a month will be held at the~     training center under the supervision of a physical education teacher.~      It will also constituted a control group remain without performing any activity during the~     study period. After 24 weeks patients receive the same advice the team conducting the~     training at home.~   "
90733|NCT02379520|"~     Subjects have a type of cancer that has been associated with an infection with a virus called~     human papilloma virus (HPV). The cancer has come back, has not gone away after standard~     treatment or the subject cannot receive standard treatment.~      This is a research study using special immune system cells called HPVST cells, a new~     experimental treatment.~      Investigators want to find out if they can use this type of treatment in patients with~     HPV-cancers. They have discovered a way to grow large number of HPV-specific T cells from the~     blood of patients with HPV-cancers. They want to see if these special white blood cells,~     called HPVST cells, that will have been trained to kill HPV infected cells can survive in the~     blood and affect the tumor. They will also see if they can make the T cells more active~     against the HPV-cancers by engineering them to be resistant to the TGF-beta chemical that~     these HPV-cancers produce. They will grow these HPVST cells from the patient's blood.~      The purpose of this study is to find the biggest dose of HPVSTs that is safe, to see how long~     they last in the body, to learn what the side effects are and to see if the HPVSTs will help~     people with HPV associated cancers.~      If the treatment with HPVST cells alone proves safe (Group A), additional group of patients~     (Group B) will receive Nivolumab in addition to HPVST cells in a lymphodepleted environment.~     Nivolumab is an antibody therapy that helps T cells control the tumor and it is FDA approved~     for the treatment of certain types of cancers, including Hodgkin's lymphoma. Lymphodepletion~     will decrease the level of circulating T cells prior to infusion of HPVST cells, thereby~     giving them room to expand. The purpose of this part of the study is to find out if TGF-beta~     resistant HPVST cells in combination with Nivolumab are safe, how long they last in the body~     and if they are more effective than HPVST cells alone in controlling the tumor.~   "
90734|NCT02379507|"~     This open-label, adaptive design study was designed to determine the efficacy of the study~     product in the treatment of eczema which would be assessed by the reduction of the appearance~     of skin lesions and symptoms associated such as itching, scaling and redness.~   "
90735|NCT02379494|"~     To evaluate the feasibility of screening for preeclampsia and fetal growth restriction~     between 11-13+6 weeks' gestation utilizing the combination of uterine artery doppler,~     maternal blood pressure, maternal characteristics, placental volume, and maternal serum~     factors, including PAPPA-A, PLGF, AFP and free Beta HCG. This is a non interventional study.~   "
90736|NCT02379481|"~     This study aims to elucidate the effects of deer bone extract NS on cognitive function~     improvement and its safety in healthy adults aged 40 to 65 years who report decline in~     subjective cognitive functions using multimodal neuroimaging and neurocognitive assessments.~   "
90737|NCT02379468|"~     The purpose of this study is to evaluate the efficacy and safety of Pedyphar® ointment in the~     healing of foot ulceration in diabetic patients.~   "
90738|NCT02379455|"~     Polypharmacy increases the risk of adverse drug effects, interactions and other drug-related~     problems, and several studies indicate that inappropriate drug use is a major reason for poor~     health and impaired function in the elderly. A majority of interventions for improvement of~     drug treatment in the elderly have been evaluated by the use of surrogate outcomes such as~     drug-related problems, number of prescribed drugs or prevalence of potentially inappropriate~     prescriptions - and it is so far unclear whether such interventions can result in clinical~     significant improvements. The primary objective of this trial is therefore to evaluate the~     effect upon patients, relatives and local health care service of a structured cooperation~     between a hospital-based geriatrician and family physicians on complex drug regimens in~     home-dwelling frail elderly patients.~   "
90739|NCT02379442|"~     Background:~      - Sometimes after stem cells are transplanted, donor cells attack the recipient s cells and~     cause tissue damage. This is called acute graft-versus-host-disease (GVHD). Researchers want~     to see if bone marrow-derived mesenchymal stem cells (BMSC) can help treat GVHD. BMSC can~     travel in the body and help repair tissue. The BMSC in this study were grown from bone marrow~     from healthy volunteers.~      Objectives:~      - To test whether BMSC are safe to use soon after GVHD is diagnosed and to see how the body s~     immune system responds to BMSC.~      Eligibility:~      - People over 4 years old who had a stem cell transplant at NIH and now have acute GVHD.~     People who have had certain previous immunosuppressive therapy may be ineligible.~      Design:~        -  Participants will be screened with medical history, physical exam, and blood tests. They~          will have a GVHD exam, including skin and stool tests. They must have a functioning~          central line.~        -  Participation will last 11 weeks: 4 8 weeks of cell infusions, then follow-up for the~          rest of the weeks.~        -  Up to 12 cell infusions:~        -  Participants will come to the clinic twice weekly.~        -  They will get medicine to prevent side effects (like Tylenol and Benadryl).~        -  BMSC will be given through a small plastic tube in an arm vein or through an IV~          catheter. It will last 20 60 minutes.~        -  Participants will be monitored for 1 hour.~        -  Follow-up visits: Up to twice a week, participants will have physical exam and blood~          tests. They may have a GVHD exam.~        -  Participants who have a tissue biopsy outside the study will be asked to send a sample~          to the study.~   "
90740|NCT02379429|"~     Background:~      Urothelial cancer is cancer of the bladder, ureter, and urethra. Researchers want to better~     understand what changes in a person s cells and genes cause this cancer to form. This may~     help them find new ways to treat it.~      Objective:~      - To perform DNA sequencing to help researchers learn the differences between normal tissue~     and tumor tissue. Also, to learn how molecular changes - including gene changes - might help~     predict the course of disease and how people respond to therapy.~      Eligibility:~      - Adults age 18 and older who have or are suspected of having urothelial cancer or an~     inherited disorder that raises their risk of getting bladder cancer.~      Design:~        -  Participants will be screened with a physical exam. Their medical records and tissue~          samples will be reviewed.~        -  Eligible participants will give tissue blocks of their original tumor. The blocks will~          be put in a tissue bank.~        -  Participants medical records may be reviewed.~        -  Participants may have a medical history and physical exam.~        -  Participants may have blood and urine tests. They may have imaging scans. They may give~          urine, blood, and saliva samples. These samples may be used in future research.~        -  If participants need surgery for their cancer, researchers will keep some of the tissue~          (both tumor and normal tissue). The tissue may be used in future research.~        -  Participants will go back to the Clinical Center in 6 months. They may give saliva,~          urine, and blood samples. After 6 months, they will be seen by their local doctor for~          standard post-surgical visits.~        -  Participants will be called every 6 months to give health updates.~   "
90779|NCT02378922|"~     This clinical trial studies gene-modified, human immunodeficiency virus (HIV)-protected stem~     cell transplant in treating patients with HIV-associated lymphoma. Stem cells, or cells which~     help form blood, are collected from the patient and stored. They are treated in the~     laboratory to help protect the immune system from HIV. Chemotherapy is given before~     transplant to kill lymphoma cells and to make room for new stem cells to grow. Patients then~     receive the stem cells that were collected from them before chemotherapy and have been~     genetically modified to replace the stem cells killed by the chemotherapy.~   "
90741|NCT02379416|"~     Background:~      - Researchers want to find better ways to treat cancer. One drug that treats cancer is~     paclitaxel. Sometimes proteins block that drug from working. Researchers want to see if~     another drug, nilotinib, helps paclitaxel work better.~      Objective:~      - To test the safety of nilotinib plus paclitaxel and find out what doses of the drugs can be~     given safely to people.~      Eligibility:~      - Adults at least 18 years old with advanced cancer that has progressed after receiving~     standard treatment, or for which no effective therapy exists.~      Design:~        -  Participants will be screened with tests they usually get in their cancer care: medical~          history, physical exam, blood and urine tests, heart test, and scans.~        -  Participants will take the two study drugs in 28-day cycles. They will keep a medicine~          diary.~        -  Nilotinib will be taken by mouth twice every day except day 1 of the first cycle.~        -  Paclitaxel will be given by IV once a week for the first 3 weeks of a cycle. This will~          usually be done at the clinic.~        -  Most participants will have a weekly study visit every week for cycle 1, then the first~          3 weeks of other cycles. They will have:~        -  Physical exam at every visit.~        -  Blood tests multiple times for cycle 1, then the first 3 weeks of other cycles.~        -  Scans every 8 weeks. These may be CT or MRI scans, in a machine that takes pictures. Or~          they may be ultrasounds, where a wand is pressed on the skin with gel on it.~        -  Around 30 days after stopping the study drugs, participants will be called to discuss~          any side effects.~   "
90742|NCT02379403|"~     Background:~      - Heart disease is the leading cause of death and disabilities in the United States. Diets~     high in fruits and vegetables may reduce the risk of heart disease. Fruits, including red~     tart cherries and purple aroniaberries, may be especially beneficial. Researchers want to~     know how tart cherry and aroniaberry extracts affect heart health.~      Objective:~      - To study the benefits of tart cherry and aroniaberry extract on vascular function and other~     measures. These include inflammation, oxidation, and cholesterol.~      Eligibility:~      - Men and post-menopausal women ages 55 70 in good health and with normal or slightly high~     blood pressure or cholesterol.~      Design:~        -  Participants will be screened with a physical exam, medical history, and blood tests.~        -  Participants will have 6 visits. They will have blood taken at every visit.~        -  Visit 1:~        -  Blood vessel tests. Participants will lie down. Heart rhythm will be monitored. A device~          will be placed on the upper arm, and pictures of blood vessels will be taken.~        -  A blood pressure cuff will be tightened around the lower arm for 5 minutes.~        -  Cardio-Ankle-Vascular Index (CAVI). Blood pressure cuffs will be placed on both arms and~          legs. They will be tightened with air at the same time for a few minutes.~        -  Participants will be assigned to one of three groups. For 3 weeks each, in random order,~          they will take: aroniaberry capsules, tart cherry capsules, placebo capsules, and no~          capsules.~        -  Participants will answer questions online about their eating and exercise.~        -  Participants will be keep a record of what they eat for a few periods. They will come~          for a study visit every 3 weeks through week 15.~   "
90743|NCT02379390|"~     Primary Objective:~      To demonstrate the superiority in term of radiographic Progression-Free Survival (rPFS) of~     cabazitaxel versus either enzalutamide or abiraterone plus prednisone in patients with~     metastatic Castration-Resistant Prostate Cancer (mCRPC) who have disease progression while~     receiving AR targeted therapy (abiraterone plus prednisone or enzalutamide) within 12 months~     of treatment initiation (≤12 months).~      Secondary Objective:~        -  To compare efficacy for:~        -  Prostate-specific antigen (PSA) response rate and Time to PSA progression (TTPP).~        -  Progression Free Survival (PFS).~        -  Overall Survival (OS).~        -  Tumor response rate and duration of tumor response.~        -  Pain response and time to pain progression.~        -  Symptomatic skeletal events (SSE) rate and time to occurrence of any SSE.~        -  To analyze messenger ribonucleic acids (mRNAs) including androgen-receptor splice~          variant 7 messenger RNA (AR-V7) as a biomarker in Circulating Tumor Cells (CTCs).~        -  To evaluate safety in the 2 treatment arms.~   "
90744|NCT02379377|"~     This clinical trial studies fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG)~     positron emission tomography (PET) in imaging patients with liver cancer before undergoing~     surgery or transplant. Diagnostic procedures, such as 18F-FSPG PET, may help find and~     diagnose liver cancer and find out how far the disease has spread.~   "
90745|NCT02379364|"~     The aim of the study will be to assess the effectiveness of Diacutaneous Fibrolysis technique~     on pain, range of motion (Patellofemoral joint mobility test and muscle length test),~     strength and function in patients with Patellofemoral Pain Syndrome and muscle shortening.~      Muscle imbalance is one of most important factor associated with Patellofemoral Pain~     Syndrome. Shortening of lateral muscles of the thigh have a close relationship with patella~     position and tracking and patellofemoral pain. The scientific evidence for effectiveness of~     any soft tissue mobilization technique in patellofemoral pain syndrome patients is poor.~      Diacutaneous Fibrolysis is a non-invasive physiotherapeutic technique to release adherences~     and fibrosis between the different musculoskeletal structures. Diacutaneous Fibrolysis is~     applied by a set of metallic hooks having the advantage of allowing a deeper and more precise~     application, which could not be achieved manually.~      The present study evaluates the effectiveness of Diacutaneous Fibrolysis technique applied in~     the soft tissues more related with patellofemoral pain.~   "
90746|NCT02379351|"~     Non-stress tests (NSTs) are used to monitor the health of babies during pregnancy. These~     tests are currently conducted in clinics and hospitals. This requires travel to a clinic or~     hospital, sometimes multiple times per week, in order to receive these tests. Technology has~     been developed that now allows for NSTs to be done in other locations, including home or~     work. The Airstrip® Sense4Baby™ NST device has been FDA-approved for use by obstetricians in~     clinical and hospital settings. The investigators are evaluating the use of the Airstrip®~     Sense4Baby™ NST device in out-of-hospital settings. The investigators would like to know if~     this type of monitoring is feasible and acceptable to patients and physicians.~   "
90747|NCT02379338|"~     In this phase 1 pilot study, positron emission tomography (PET/CT) imaging will be used to~     determine the biodistribution, metabolism and excretion of a novel radiotracer~     [18F]Fluortriopride ([18F]FTP).~   "
90812|NCT02378493|"~     This is an observational study that does not change routine care.~      The primary objective of this study is to investigate the role of~     antibiogramme-antibiofilmogramme concordance (in terms of S. aureus strains and prescribed~     antibiotics) in the presence/absence of S. aureus strains at the end of a first regimen of~     antibiotics.~   "
90748|NCT02379325|"~     Smoking cessation is a priority for preventing smoking-attributable disease and reducing its~     burden. Quitting smoking at any age confers substantial and immediate health benefits,~     including reduced risks of stroke, cardiovascular disease and smoking-related cancers, and~     quitting smoking by the age of 30 reduces the risk of dying from tobacco-related diseases by~     almost 90%. The World Bank suggests that if adult cigarette consumption were to decrease by~     half in the year 2020, approximately 180 million tobacco-attributable deaths could be~     avoided. Therefore, promotion of smoking cessation has been proposed as a primary focus of~     tobacco control efforts, especially in developing countries where smoking prevalence and~     cigarette consumption are both still relatively high~   "
90749|NCT02379312|"~     To compare, in a randomized, single-blinded, cross-over study the satiety effect of a very~     low energy aerated beverage with normal energy aerated beverages in healthy subjects.~   "
90750|NCT02379299|"~     The ultimate T1D treatment tool is a closed-loop glucose control system, i.e. a fully~     automated system for intensive insulin treatment. Such system will ease the burden of~     constant treatment decision-making and at the same time it has the potential to safely~     intensify insulin therapy such that more patients can reach treatment goals. Currently, no~     off-the-shelf closed-loop system exists but research efforts in this field have been~     intensified and resulted in great progress in recent years. Most closed-loop systems consist~     of an insulin pump, a CGM, and a control algorithm residing on a mobile computer that~     continuously (every 5-15 min) computes the optimal insulin dosage from the CGM values. For~     daytime blood glucose control, however, we believe that the system needs to be further~     advanced. Consequently, we have extended our single-hormone closed-loop system such that it~     now includes a second pump for glucagon delivery and correspondingly we have further~     developed our control algorithm to compute both insulin and glucagon dosages.~      We hypothesize that we have developed a safe and effective dual-hormone closed-loop system~     for patients with type 1 diabetes and that this system is superior to single-hormone~     closed-loop therapy. The aims of this two-phase project are to 1) demonstrate~     proof-of-concept and 2) to compare dual-hormone with single-hormone closed-loop glucose~     control.~   "
90751|NCT02379286|"~     The main objective is to assess the relationships between French teenagers' attitudes and~     beliefs towards alcohol and tobacco products and the degree to which they watch and relate to~     television series and music videos.~   "
90752|NCT02379273|"~     This post approval study evaluates the long term safety and efficacy of the Nucleus Hybrid~     L24 Implant System in a group of already implanted recipients.~   "
90753|NCT02379260|"~     The aim is to built a Therapeutic Education Program for patients treated with radical~     prostatectomy in order to improve their sexuality.~      This study is carried out in two steps :~        -  Identification of specific educational objectives through a sociological study, with~          interviews and focus groups conducted and analyzed by a sociologist. Patients from the~          urology department of the hospital center (CH) Lyon Sud - Hospices Civils de Lyon (HCL)~          will be included~        -  Development of the program by a caregiver education expert (Centre Hygée), adapted~          partly from results of the qualitative study and partly from concepts and tools from the~          Education Sciences.~   "
90754|NCT02379247|"~     Investigate the use of BYL719 as combination therapy with Nab-Paclitaxel in locally recurrent~     or metastatic HER-2 negative breast cancer.~   "
90755|NCT02379234|"~     Continuous Veno-Veinous Hemofiltration (CVVH) is a frequently used renal replacement therapy~     in intensive care units for patients with acute renal failure. In theory, this therapy should~     be continuous, 24 hours/day.~      However, it is wellknown that actual duration of CVVH sessions is much lower than scheduled,~     with frequent circuit down-times (between 1 to 6 hours/day). There are many reasons for~     premature ending of CVVH sessions (i.e. catheter dysfunction, wrong settings, low~     anticoagulation…), but early detection of any dysfunction may prevent (at least in part) the~     CVVH circuit coagulation. ICU Nurses are on the first line to manage CVVH sessions,~     particularly in case of alarms.~      High-fidelity simulation has been recently proposed for health care provider education. It~     has been consistently associated with large effects for outcomes of knowledge, skills, and~     behaviors but with moderate effects for patient related outcomes. Indeed, few studies have~     assess the impact of simulation on patient outcome following complexe procedures, that~     implies team work in addition to individual skills.~      In our 12-bed surgical ICU, investigators have decided to implement CVVH technics (in~     addition to the dialysis that we already used). Before implementing this new technic in the~     ICU, investigators designed this study in order assess wether a high-fidelity based~     ICU-nurses education program would improve the outcome of CVVH sessions, compared to the~     conventional education program, proposed by the CVVH manufacturer.~   "
90756|NCT02379221|"~     The purpose of the study is to compare two modalities of local anesthetic administration~     prior to the placement of cosmetic facial injectable fillers. Both short and long term pain~     perceptions for the facial filler procedure will be compared in patients receiving 4%~     Topicaine gel on half their face and 2% lidocaine 1:100k epinephrine nerve block injections~     on the other half of their face. The objective is to quantify the subjective pain experienced~     by these two modalities of local anesthetic during the procedure of Juvederm XC filler~     injections.~   "
90757|NCT02379208|"~     The purpose of this study is to evaluate rate of progression in newly diagnosed open angle~     glaucoma with different types of perimetry. Would it be possible to find the rapidly~     progressing individuals sooner by doing perimetry more often? Is there a difference between~     different types of perimetry in early glaucoma? What would be the optimal timing of perimetry~     in newly diagnosed glaucoma? In addition the quality of life in glaucoma patients will be~     evaluated with two types of questionnaires in three different time points. The enrolled~     patients will receive appropriate treatment according to glaucoma management guidelines.~   "
90780|NCT02378909|"~     Diabetes mellitus is one of the leading causes of illness worldwide. Diabetes can affect~     nerves, skin and blood vessels. Diabetics with problems in their nerves can lose the sense of~     touch in their feet (called neuropathy) and so may unknowingly cause damage to the skin~     resulting in skin loss or an 'ulcer'. Diabetics also have difficulty healing any damaged~     tissues especially if the patients have diseased blood vessels causing a lack of blood to~     areas of the body including the feet (called ischaemia).~   "
90781|NCT02378896|"~     This study will evaluate the effects of a computerized training program coupled with~     cognitive behavioral therapy (CBT) for OCD.~   "
90758|NCT02379195|"~     Adoptive T cell therapy with tumor infiltrating lymphocytes (TIL) has achieved impressive~     clinical results with durable complete responses in patients with metastatic melanoma. The~     TILs are isolated from the patients own tumor tissue followed by in vitro expansion and~     activation for around 4-6 weeks. Before TIL infusion the patients receive 1 week of~     preconditioning chemotherapy with cyclophosphamide and fludarabine. After TIL infusion~     Interleukin-2 are administered to support T cell activation and proliferation in vivo.~      In this trial the therapy is combined with peginterferon (the pegylated form of interferon~     alpha 2b). Interferon alpha has immunomodulatory effects and is known to upregulate HLA~     expression on melanoma cells and are hypothesized to synergize with TIL therapy.~   "
90759|NCT02379182|"~     Prospective, randomized, controlled, three-arm, open-label, blinded analysis. Patients~     admitted with stroke diagnosis and with suspected dysphagia that meet the initial inclusion~     and exclusion criteria will be consented into the clinical investigation. Patients who meet~     the second set of inclusion criteria (dysphagia confirmed by VFS) will be randomized to~     either active (motor or sensory) or standard treatment (control group) arms.~      Subjects included in this clinical investigation will be evaluated at screening, 1-week,~     3-months and at 12-months post treatment.~      The main aim of the study will be to assess the effect of VitalStim therapy on improving the~     safety of swallow according to the VFS, after the treatment and at 1-year follow up, on~     patients with chronic post-stroke OD.~   "
90760|NCT02379169|"~     Low macular pigment optical density has been associated with increased risk of age-related~     macular degeneration, an important cause of vision problems in the elderly population. Dry~     eye is multifactorial disease of tears and the ocular surface associated with symptoms of~     dryness, grittiness, burning and redness of eyes. The risk of dry eye increases with age. The~     aim is to investigate the effects of sea buckthorn oil complemented with lutein on eye~     health, specifically on the macula.~   "
90761|NCT02379156|"~     The ability to maintain normal core body temperature (Tcore = 98.6°F) is impaired in persons~     with a cervical spinal cord injury (tetraplegia). Despite the known deficits in the ability~     of persons with spinal cord injury (SCI) to maintain Tcore, and the effects of hypothermia to~     impair mental function in able-bodied (AB) persons, there has been no work to date addressing~     these issues in persons with tetraplegia.~      Primary Aim: To determine if exposure of up to 2 hours to cool temperatures (64°F) causes~     Tcore to decrease in persons with tetraplegia, and if that decrease is associated with a~     decrease in cognitive function.~      Primary Hypotheses: Based on our pilot data: (1) 66% of persons with tetraplegia and none of~     the matched controls will demonstrate a decline of 1.8°F in Tcore; (2) 80% of persons with~     tetraplegia and 30% of controls will have a decline of at least one T-score in Stroop~     Interference scores (a measure of executive function).~      Secondary Aim: To determine the change in: (1) distal skin temperature, (2) metabolic rate,~     and (3) thermal sensitivity.~      Secondary Hypothesis: Persons with tetraplegia will have less of a percent change in average~     distal skin temperatures and metabolic rate, and report lower thermal sensitivity ratings~     compared with AB controls.~      Tertiary Aim: To determine if a 10 mg dose of an approved blood pressure-raising medicine~     (midodrine hydrochloride) will (1) reduce the decrease in Tcore and (2) prevent or delay the~     decline in cognitive performance in the group with tetraplegia compared to the exact same~     procedures performed on the day with no medicine (Visit 1) in that same group.~      Tertiary Hypothesis: Through administering a one-time dose of midodrine, the medicine-induced~     decreased blood flow to the skin will lessen the decline in Tcore and prevent or delay the~     associated decline in cognitive performance compared to the changes in Tcore and cognitive~     performance during cool temperature exposure without midodrine in the same group with~     tetraplegia.~   "
90762|NCT02379143|"~     Various national & international bodies like FDA, CSP has laid down the guidelines for the~     reasonable use of SWD electro therapeutic agent (EPA) ensuring safety & effectiveness.~      However, it remains uncertain, whether the practicing physiotherapists are aware of the very~     existence of this guidelines and implementing them in daily practice. Any lack of knowledge~     about this background can endanger the patient safety leading to serious health hazards.~      In the present survey, 49 physiotherapy practitioners were interviewed with a self-report~     measure to investigate their knowledge base, mode of application of SWD (6 items) & the~     awareness about recommended guidelines (5 items) etc.~   "
90763|NCT02379130|"~     The purpose of this study is to determine the effects of Family Nurture Intervention in~     preschool aged children between 2.5 and 4.5 years of age who were born prematurely and~     exhibit developmental deficits. The new approach is based on improving aspects of maternal~     nurturing behaviors as well as mother-child co-regulation, which are important to early~     development. Since young children with developmental deficits are often easily upset, mothers~     will be taught how to co-regulate with their child through comfort and calming interactions~     during 11 clinic visits. Assessments in the follow-up clinic will test the immediate and~     long-term effects of this new approach to the nurture of children who were born early and~     demonstrate developmental problems and behavioral problems.~   "
90764|NCT02379117|"~     Food intake is mainly controlled through interactions between the gut and brain (the~     homeostatic control) and through our environment, with food exposure, mood and past~     experiences (the hedonic control) playing a major role. The link between the gut and the~     brain is mainly controlled through enteroendocrine cells (EC). These cells in the bowel sense~     nutrients in the food and link with the brain to control how much we eat. They make a number~     of hormones that link with the brain to control one's eating habits.~      Crohn's disease (CD) is an inflammatory disease of the bowel which can present with a number~     of symptoms including weight loss and loss of appetite. We thought some time ago that an~     increase in the number and function of these EC could play a central role. Since then we have~     carried out work which has shown that in CD these EC increase in number and produce more~     hormones after a meal. This finding could have a negative effect on food intake. This would~     be one explanation to the symptoms so commonly experienced by these patients.~      In CD we thus feel that there might be an imbalance in the appetite control. We expect an~     increasingly sensitive gut to food intake and a subdued mood and perception to food reward~     and that this imbalance will lead to a decrease in food reward and consequently a decrease in~     food intake.~      This study will be carried out using Healthy Volunteers and CD patients. We plan to measure~     food intake though telephone interviews and plan to analyse eating behaviour through 5~     questionnaires.This study will help us to improve our understanding of what it is that~     controls food intake. This will be particularly important to patients with CD who routinely~     lose weight and appetite.~   "
90765|NCT02379104|"~     ROTEM® sigma is a new thromboelastometric coagulation analysis system. The new system is~     fully automated allowing for a simple and safe operation compared to its predecessor model~     ROTEM® delta.~      Method comparison of ROTEM® sigma with predecessor model ROTEM® delta) - confirmation of~     equality.~      Confirmation of reference intervals of the ROTEM® systems.~   "
90766|NCT02379091|"~     The purpose of this study is to establish proof of concept and identify the optimal~     efficacious dose for namilumab in RA in patients with an inadequate response to methotrexate~     (MTX-IR) and in patients with an inadequate response to one tumor necrosis factor~     (TNF)-inhibitor (TNF-IR).~   "
90767|NCT02379078|"~     Diabetes care is complicated for people with diabetes as well as for health care providers:~     they have to watch their diet, exercise, take medications, checking blood sugars and blood~     pressure, get tests and see multiple doctors. On top of that, many with diabetes have other~     health problems, such as high blood pressure or arthritis, that make care even more~     complicated. Guidelines for improving the care of people with diabetes try to help by~     summarizing the best practices for care, but because diabetes care is so complicated, it is~     hard for them to be put into practice. One solution to this is a tool that can help people~     with diabetes set health care goals that are important to them, and participate actively in~     decisions about their own health care, together with health care providers. This tool would~     have an information booklet for patients with facts that can help them make a decision, a~     worksheet to help spell out what their goals are and how they want to get there, and a~     cheat-sheet for health care providers that gives them tips on how to do this. The purpose of~     this project is to find out if a tool like this would be helpful, how to make it more helpful~     and usable, and what the best way would be to make sure that people use it.~      An interprofessional (IP) shared decision-making (SDM) and goal-setting tool kit, including a~     1-page provider enabler, a point-of-care worksheet and a patient workbook, can be implemented~     successfully in clinical practice and will reduce decisional conflict and diabetes distress~     and improve chronic care delivery and quality of life in patients with type 1 or type 2~     diabetes and 2 other comorbid chronic diseases. The investigators hypothesize that patients~     in the intervention arm of the study will have reduced decisional conflict and diabetes~     distress, and improved decision-making satisfaction, chronic care delivery and quality of~     life.~   "
90768|NCT02379065|"~     The investigators are looking at whether a new type of nebuliser (a machine used to deliver~     drugs to the airways) is better at delivering drugs to the lungs of people with Chronic~     Obstructive Pulmonary Disease (COPD), compared with the current nebulisers used in Emergency~     Departments. The investigators will randomly allocate patients who come into the Emergency~     Department with an acute episode of the COPD into either the standard nebuliser group or the~     new nebuliser group.~      Both groups will receive the same medications, it is only the method of delivering them which~     will be different.~   "
90769|NCT02379052|"~     The primary objective of the study is to assess the clinical efficacy of repeat subcutaneous~     (SC) doses of dupilumab, compared with placebo, to relieve symptoms in adult patients with~     active, moderate to severe EoE.~      The secondary objectives of the study are:~        -  To assess the safety, tolerability, and immunogenicity of SC doses of dupilumab in adult~          patients with active, moderate to severe EoE~        -  To assess the effect of dupilumab on esophageal eosinophilic infiltration~        -  To evaluate the pharmacokinetics (PK) of dupilumab in adult patients with EoE~   "
90770|NCT02379039|"~     The study's aim is to define imaging and molecular bio-markers for prediction of radiotherapy~     response of squamous cell carcinomas, in an early treatment phase.~   "
90771|NCT02379026|"~     This study evaluates the addition of a high-protein energy-restricted diet to exercise in the~     treatment of sarcopenic obesity in people aged 65 and over. Half of participants will follow~     a hypocaloric (500 kcal deficit) high-protein (1.2 -1.5 g Protein/ kg bodyweight) diet~     alongside an exercise regime, while the other half will follow the same exercise regime~     alongside their habitual diet . All participants will consume a Vitamin D3 tablet~     (25micrograms) 3 times a week to achieve a weekly intake of 75 micrograms. Total duration of~     the intervention will be 16 weeks.~   "
90772|NCT02379013|"~     The purpose of this study is to determine more objective, central and peripheral indices of~     fatigue state by exploring the neural and behavioral correlates of the alert process while~     keeping the idea to corroborate these results with those obtained during the performance of~     physical exercises and neuropsychological tests classics of attention, motivation, and~     functions evaluation. The interest of this study is to manipulate and compare the phasic and~     tonic alert mechanism through the activation of an extrinsic motivational system during~     fatigue. The investigators have chosen the alert since it is a basic cognitive process~     defined as the ability to increase attentional resources with the expectation of a target~     stimulus resulting in reduced response time. It can be phasic (extrinsic), favored by the~     presence of a warning signal preceding the target (preparation time) or tonic (intrinsic)~     occurring without warning signal (wakefulness). The evaluation of the alert is classically~     realized by a simple reaction time task with the presence or not of warning signal soliciting~     wether the tonic alert or the phasic alert.~      The investigators suppose to revisit the healthy population with brain model alert issued in~     2010 which highlighted the predominant role of the regions of the dorsolateral prefrontal~     cortex, parietal, cingulate and thalamus (non-motor) in maintaining attention and temporal~     preparation alert task.~      The investigators identify also functional, motor and cognitive components of basal ganglia~     of thalamus. Cognitive-motor paradigm and neurological dysfunctions observed in multiple~     sclerosis population will help to identify and separate the cognitive role and motor brain~     regions, particularly the thalamus and basal ganglia. New neurological hypotheses are~     proposed~   "
90773|NCT02379000|"~     Proton beam therapy is a safe irradiation modality for choroidal melanoma. But often after~     irradiation the exudation increases resulting in an exudative retinal detachment requiring~     vitreoretinal surgery. It is known that intravitreally injected triamcinolone and TTT is~     capable to decrease the exudation. If there is any advantage in a combined treatment this~     study will investigate.~   "
90774|NCT02378987|"~     The aims of this study:~        1. to investigate the difference in motor speech functions among children with cerebral~          palsy (CP) of different motor severities.~        2. to investigate the longitudinal in motor speech functions at 6 months follow-up phase~          among children with CP of different motor severities.~        3. the correlation between motor severity, personal factors, family factors, language~          ability and motor speech in children with CP.~        4. to identify the variables that can predict motor speech functions in children with CP.~   "
90775|NCT02378974|"~     The objective of the study is to evaluate the safety and the potential therapeutic effects~     per dose of Cordstem-ST Intravenous Transplantation in Cerebral Infarction subjects comprised~     of 2 treatment cohorts:~      Cohort 1 : Cordstem-ST 2.0 x 10^8 cells or Placebo on day 0~      Cohort 2: Cordstem-ST 2.0 x 10^8 cells or Placebo on day 0 and day 7~   "
90776|NCT02378961|"~     The primary objectives of the study are to evaluate the safety, tolerability, and efficacy of~     voxilaprevir (VOX) plus sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) in~     adults with chronic non genotype 1 hepatitis C virus (HCV) infection.~   "
90777|NCT02378948|"~     The aim of this study is to investigate the effects of early start versus delayed start of~     oral intake on postoperative functional recovery after an esophagectomy.~   "
90778|NCT02378935|"~     This primary objectives of the study are to evaluate the safety, tolerability, and efficacy~     of voxilaprevir (VOX) plus sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) ±~     ribavirin (RBV) in adults with chronic genotype 1 hepatitis C virus (HCV) infection.~   "
90783|NCT02378870|"~     This phase IIb study is a randomized, double-blind, placebo-controlled multi-center study~     evaluating efficacy and tolerability of Osteodex of patients with metastatic castration~     resistant prostate cancer (CRPC). Osteodex is a poly-bisphosphonate containing three known~     substances; dextran, alendronate and guanidine.~      The objective of the study is to evaluate the relative change of response markers to bone~     metabolism (B-ALP and S-P1NP) The following objectives will also be evaluated: overall~     survival, PSA response, other response markers related to bone metabolism (S-CTX and~     osteocalcin), safety, tolerability, pain and quality of life.~   "
90784|NCT02378857|"~     Cross-sectional study of a national cohort of adolescents with univentricular congenital~     heart defects and Fontan type palliation.~   "
90785|NCT02378844|"~     A prospective, double-blind, randomized, sham-controlled, multicentre investigation.~   "
90786|NCT02378831|"~     The WP200 and/or WP200U will be compared with a PSG system which is a digital physiological~     recorder system, cleared for use for clinical sleep studies. The manual scoring of the PSG~     data, performed by a trained and authorized scorer, according to the AASM (American Academy~     of Sleep Medicine) guidelines, serves as a gold standard for all determinations of~     efficacy.~   "
90787|NCT02378818|"~     This research focuses on disorders of motivation, responsible for a disability that patients~     experience daily. It is a disorder that affects behavior, especially social. Mechanisms,~     which result in these disorders, are poorly understood. This ignorance is responsible for the~     lack of effective therapy. The investigators realize this work in order to better understand~     the motivational deficits. The objective of the study is to characterize the cognitive~     mechanisms of motivational deficits in schizophrenia and depression. To answer the question~     posed in the research, it is planned to include 35 people with schizophrenia, 35 people with~     depression and 70 heathy volunteers in the Hospital of Sainte-Anne .~   "
90788|NCT02378805|"~     The hereditary type IV collagen disease Alport syndrome inevitably leads to end-stage renal~     disease. Currently there are no therapies known to improve outcome. Our non-interventional,~     observational study investigates, if medications such as ACE-inhibitors can (1) delay time to~     dialysis and (2) improve life-expectancy within three generations of Alport-families in~     Europe.~   "
90789|NCT02378792|"~     Evaluate the long-term clinical effectiveness and safety of the PINS vagus nerve stimulator~     to patients with refractory epilepsy.~   "
90790|NCT02378779|"~     Many male patients complain about their ejaculation: 21-30% of men aged between 18 and 59~     have admitted suffering from a decrease in, or loss of control of, their ejaculation. The~     quality of life of patients and their partners is impaired compared to men not suffering from~     premature ejaculation. Economically, the impact of the disease are significant. In the year~     preceding the detection of premature ejaculation patients visit twice their physician. The~     majority of men interviewed anonymously, in their General Practitioner's ( GP's) waiting~     room, considered it important to talk with their GP about their sexual concerns. Almost half~     of them preferred that their GP initiate any discussions about sexuality. More than two~     thirds of the respondents would have liked their GP to signal his or her open-mindedness by~     directly addressing sexual topics during the consultation. In 2008 a qualitative study~     brought to the fore the strategies used by GPs to initiate the discussion on premature~     ejaculation . GPs who mentioned premature ejaculation with their patient described three~     attitude-related strategies and three investigative strategies.~   "
90791|NCT02378766|"~     The purpose of this study is to evaluate the efficacy of a web-based tailored intervention to~     support persons living with HIV (PLHIV) manage the demands inherent to their health~     condition, particularly as regards to the adoption of health behaviours such as being~     physically active, following a healthy diet and quitting smoking.~      This randomized controlled trial is currently conducted entirely online at~     www.lhivehealthy.ca~   "
90792|NCT02378753|"~     The 2014 outbreak of Ebola in West Africa is the largest in recorded history with widespread~     and intense transmission in Guinea, Liberia, and Sierra Leone. The high infectivity of blood~     and secretions, lack of appropriate personal protective equipment (PPE) and challenges in~     following infection control and prevention protocols put healthcare workers at high risk~     during outbreaks, and direct contact with the bodies of deceased Ebola victims can also~     sustain community transmission. This study will accelerate introduction and use of monovalent~     recombinant vesicular stomatitis virus Ebola vaccine (rVSVΔG-ZEBOV) among healthcare workers~     and frontline personnel involved in the Ebola outbreak response in Sierra Leone, while~     concurrently evaluating the safety and efficacy of the vaccine.~      This is an unblinded, randomized trial with phased vaccine introduction in the target~     population. Participation in the study will be voluntary and open to adults 18 years of age~     and older who are at high risk of exposure to Ebola infection through their daily work and~     who work in a selected study area.~   "
90793|NCT02378740|"~     Ketamine is an IV anesthetic with non-opioid analgesic properties that has been shown to~     reduce pain while also decreasing intraoperative and postoperative opioid requirements when~     used in subanesthetic doses after a variety of surgical procedures.1 It is a non-competitive~     antagonist of N-methyl-D-aspartate (NMDA) receptors, and by this mechanism ketamine is~     believed to block the development of central sensitization and wind-up phenomenon,2,3 which~     may be helpful in preventing acute and chronic pain after repetitive insults. In a systematic~     review of ketamine as an adjuvant to opioid analgesia, low-dose ketamine was found to be a~     useful addition to standard postoperative pain management practice with opioids in 54% of~     studies.1 The studies that did not show a significant effect were in patient populations with~     low opioid requirements. Therefore, it has been suggested that future clinical trials be~     focused on patient populations with significant post-operative pain, such as spine surgery~     and major orthopedic surgery not amenable to regional analgesia, and postoperative pain in~     patients on chronic preoperative opioid therapy.1~      There are few studies examining outcomes after ketamine in the perioperative period after~     spine surgery. Loftus et al randomized patients with a history of chronic preoperative opioid~     use (i.e., daily opiate use for at least 6 weeks) to intraoperative ketamine versus placebo~     and found a 30% reduction in morphine consumption at 48 hours and an approximately 25%~     reduction in visual analog scale (VAS) pain score in the post anesthesia care unit and at 6~     weeks.4 Although this study provided evidence that there may be reduction in long-term~     postoperative pain, additional studies are needed to provide evidence that this effect is~     sustained beyond the 6-week period.~      We are interested in examining ketamine more closely in spine surgery because this patient~     population experiences significant postoperative pain that may be difficult to control due to~     preoperative opioid use (i.e., opioid tolerance). The investigators chose to study ACDF~     patients specifically because it is a common spine procedure throughout the United States and~     the patients have significant opioid requirements postoperatively. In a study examining the~     effects of the low dose ketamine for postoperative IV PCA fentanyl after cervical and lumbar~     surgery, patients in the placebo group (and thus only receiving fentanyl PCA) reported mean~     VAS scores of 4-5 with movement while receiving opioids.5~      Further, while previous studies have shown an opioid-sparing effect of ketamine as measured~     by opioid consumption and a decrease in pain as measured by VAS scores, no study to our~     knowledge has examined quality of recovery after intraoperative ketamine infusion. The~     Quality of recovery (QoR-40) score was developed by Myles et al to assess quality of recovery~     after anesthesia based on forty questions in five dimensions,6 and this score has been shown~     to be a reliable and valid outcome for patients undergoing both spine and cranial surgery.7~     QoR-40 is also of interest because it should be able to provide a global assessment of the~     possible benefit or harm of using ketamine in patients by simultaneously characterizing the~     detrimental side effects as well as the positive benefits of ketamine when used as an~     infusion at subanesthetic levels (studies thus far have shown that there are minimal side~     effects such as hallucinations).1,4~      Significance:~      Previous studies have shown an opioid-sparing effect of ketamine, however further research is~     warranted in patients whose pain may be difficult to control and whether this effect is~     sustained. ACDF patients experience significant pain post-operatively, and ketamine may~     improve their quality of recovery due to its opioid-sparing effects and prevention of chronic~     pain. Further, patient centered outcomes as measured by the QoR-40 have not been reported in~     the literature when ketamine, or other opioid sparing anesthetics, have been administered.~     This study will not only determine if the moderate dose of ketamine is beneficial or~     detrimental to the recovery of patients but also whether it can improve long term patient~     function, presumably by decreasing central pain sensitization. In addition, this study will~     set the stage for further RCT's examining other analgesic strategies in cervical spine~     surgery patients (i.e., intraoperative lidocaine infusions, volatile anesthetic vs. propofol~     as the primary hypnotic, COX-2 inhibitors, pregabalin, etc.). The overall goal would be to~     develop a multi-faceted regimen that decreases the postoperative inpatient opioid~     requirements of these patients and may facilitate long term recovery.~      The research questions:Does ketamine improve the quality of recovery at 24 hours after~     anterior cervical discectomy and fusion (ACDF)? The hypothesis: the investigators hypothesize~     that ketamine will improve the quality of recovery after ACDF surgery~   "
90794|NCT02378727|"~     The purpose of this pivotal study is to demonstrate safety and effectiveness of the CompuFlo®~     Epidural Computer Controlled System (referred to hereafter as CompuFlo® Epidural) for the~     epidural space verification.~      The CompuFlo® Epidural System is limited by federal law for investigational use only in~     United States of America and has received CE mark in European Union.~   "
90795|NCT02378714|"~     Persons who struggle with depression smoke at high rates and experience low quit rates in~     treatment. The best way to improve cessation treatment for this underserved population~     remains unknown. The proposed trial tests whether the combination of varenicline and~     behavioral mood management treatment enhances long-term abstinence for depressed smokers and,~     if so, whether this treatment achieves its effects through addressing the unique~     psychological factors that appear to maintain tobacco dependence for these smokers.~   "
90796|NCT02378701|"~     The goal of this research study is to test a quality-of-life questionnaire called QUALMS-1 in~     patients with MDS.~   "
90797|NCT02378688|"~     The primary objectives of the study are:~        -  To evaluate the safety and tolerability of MT-1303 in subjects with moderate to severe~          active Crohn's Disease（CD）~        -  To evaluate the clinical efficacy of MT-1303 in subjects with moderate to severe active~          CD.~   "
90813|NCT02378480|"~     The purpose of this study is to evaluate the safety and efficacy of omadacycline as compared~     to linezolid in the treatment of adults with acute bacterial skin and skin structure~     infections.~   "
90798|NCT02378675|"~     Apelin, Visfatin, Omentin and Resistin are adipocytokines derived from human adipose tissue~     as well as placental tissue and have been shown to be potential mediators of insulin~     resistance. In each pregnancy, a physiological Insulin resistance syndrome occurs to ensure~     that the fetus is sufficiently supplied with glucose. Due to their impact on glucose~     transport mechanisms adipocytokines play an important role for the development of insulin~     resistance.~      Gestational diabetes mellitus (GDM) is one of the most common pregnancy - associated diseases~     with a prevalence of 5-10% of all pregnancies and its prevalence is increasing. It is~     associated with severe hazards to both mother and fetus such as macrosomia, plexus palsy,~     premature delivery and intrauterine death. Furthermore, up to 50% of women with GDM develop~     Type 2 Diabetes Mellitus (DM2) within the following ten years after pregnancy. GDM seems to~     be a potent risk factor for the development of DM2 in later life by sharing a number of~     epidemiological, physiological and genetic characteristics with DM2. Therefore, alterations~     in adipocytokine levels in women with GDM, if present, may resemble those observed with DM2.~      Furthermore, the exact pathogenesis of GDM is not completely understood, however, increased~     insulin resistance is a well demonstrated mechanism.~      Adipocytokines are known to alter insulin resistance through several mechanisms described in~     the literature. The investigators therefore expect a possible relationship between the above~     described adipocytokines and gestational diabetes mellitus.~      Results of the HAPO-Study have shown a significant association between fetal outcome and mean~     blood glucose levels in women suffering from GDM. The HAPO Study group supposed a possible~     relationship between GDM and fetal insulin levels and used C-Peptide to quantify fetal~     hyperinsulinemia.~      A recent study suggests that not only hyperglycemia but also altered maternal lipid~     metabolism may constitute a risk factor for macrosomia in GDM.~      In summary, the investigators aim to illuminate a possible association between the~     adipocytokines Apelin, Omentin, Resistin and Visfatin, lipid metabolism and gestational~     diabetes mellitus.~   "
90799|NCT02378662|"~     The objectives of this study are to assess safety and to evaluate the biologic activity of~     TARGTEPO treatment in Peritoneal Dialysis patients~   "
90800|NCT02378649|"~     A randomized, placebo controlled, single center clinical trial for evaluation of efficacy and~     safety of Sildenafil administration in the cardiac ICU following Mitral Valve (MV) Surgery in~     patients with pre-operative Significant Pulmonary Hypertension.~   "
90801|NCT02378636|"~     This will be a prospective, open-label, 125 subject (maximum), two-year multicentre~     investigation to assess the safety, effectiveness and rotational stability of the modified~     600C (axis marks) intraocular lens (IOL) in subjects undergoing cataract extraction.~   "
90802|NCT02378623|"~     Patients with a patent foramen ovale in the setting of endocardially placed cardiac~     implantable electronic devices such as pacemakers, defibrillators, or resynchronization~     therapies are likely at higher risk for paradoxical embolic events from device lead thrombus.~     The investigators are conducting this study to determine if the anticoagulant medication~     Apixaban is more effective at reducing MRI detected brain lesions compared to placebo.~   "
90803|NCT02378610|"~     The relationship between the gut microbiota and stress is poorly studied in humans. In this~     study we aim to look for if stressed persons have different levels of key bacterial groups~     compared to the levels in non-stressed persons.~   "
90804|NCT02378597|"~     To develop and test a 4-session program to teach resiliency skills to Medical Interpreters.~   "
90805|NCT02378584|"~     This study evaluates the difference in pregnancy rate transferring a healthy blastocyst in~     natural or artificial cycle.~   "
90806|NCT02378571|"~     The overall purpose of this project is to determine the feasibility of conducting a large~     scale randomized clinical trial that compares remote monitoring of adherence to loop~     diuretics using a wireless electronic pillcap with usual care among recently hospitalized~     heart failure patients. The long-term goal of this program of research is to determine the~     effect of the adherence telemonitoring intervention on medication adherence and hospital~     readmissions among recently hospitalized heart failure patients.~   "
90807|NCT02378558|"~     This small pilot will allow surgeons to perform wireless breast lumpectomies using a new~     magnetic technology. This is a continuation of a previous project testing the technology, and~     the breast surgeons comfort level using this new technology.~      The aim of this project is to develop a new technique for surgical excision of lesions either~     through surgical biopsy or lumpectomy. The current standard of care involves placing a needle~     then slender wire through the lesion under image guidance by a radiologist. The surgeon then~     removes the lesion using the wire as a guide. This new technique would place a magnet through~     the lesion under image guidance by a radiologist. The surgeon would then use the MagneProbe~     in the operating room to locate the magnet and remove the lesion. This new technique would~     eliminate the use of a wire that protrudes from a patient's breast. This wire is usually~     placed on the day of surgery, prior to the procedure. The goal of this new technique is to~     eliminate wire placement and increase patient comfort throughout the day of her surgery.~   "
90808|NCT02378545|"~     The motivation for this study comes from a desire to improve the mortality of patients with~     sepsis. Oxygen is cheap, readily available and is included in current United Kingdom~     Emergency Department guidelines, but it may also be harmful to patients with sepsis - it is~     important to know if this is the case.~      This study is a pilot study to also assess the feasibility of delivering a larger adequately~     powered study.~   "
90809|NCT02378532|"~     Patients with a glioblastoma (GBM) have a poor prognosis with a median survival of 14.6~     months after maximal treatment with a resection and chemoradiation. Since the pivotal trial~     evaluating the effect of temozolomide (TMZ), overall survival has not increased.~      Treatment of GBM xenografts in vivo with chloroquine (CQ), an antimalarial agent, has been~     shown to reduce the hypoxic fraction and sensitizes tumors to radiation. Epidermal growth~     factor receptor (EGFR) amplification or mutation is regularly observed GBM and is thought to~     be a major contributor to radioresistance. The most common EGFR mutation in GBM (EGFRvIII) is~     present in 50-60% of patients whose tumor shows amplification of EGFR. EGFR provides cells~     with a survival advantage through autophagy when exposed to stresses such as hypoxia and~     nutrient starvation. This effect is even more pronounced in EGFRvIII overexpressing tumors.~     Previously, the potential effect CQ has been demonstrated in a small randomized controlled~     trial in GBM treated with radiotherapy and carmustine, which showed a trend towards increased~     overall survival. However, as the intracellular effects of chloroquine are dose-dependent the~     maximum tolerated dose for CQ in combination with concurrent radiotherapy with daily~     temozolomide needs to be established.~   "
90810|NCT02378519|"~     The aim of the study is to evaluate the effects of a the multimodal treatment with a~     web-based self-help program with cognitive behavioral therapy coaching and individual~     tailored physiotherapy on workability, health behavior and pain symptoms for persons with~     persistent pain.~   "
90811|NCT02378506|"~     Open-label immunogenicity, safety and efficacy study of etanercept manufactured using the~     high capacity process. Descriptive results will be provided however a formal hypothesis will~     not be tested in this trial.~   "
90814|NCT02378467|"~     The purpose of this study is to assess whether inhalation of 7% hypertonic saline (HS) twice~     daily for 48 weeks improves the lung clearance index by multiple breath nitrogen washout in~     comparison with inhalation of 0.9% isotonic saline (IS) in preschool children (ages 3 to 5)~     with cystic fibrosis.~   "
90815|NCT02378454|"~     This study compares the lung clearance index (LCI) in cystic fibrosis and healthy children~     obtained with two different multiple breath nitrogen washout (MBWN2) devices. Each~     participants will perform the test (LCI) in duplicate on each device.~   "
90816|NCT02378441|"~     This study is designed to evaluate safety and pharmacokinetic properties of the two~     treatments, the administration of CJ-30056 and the co-administration of atorvastatin 20mg and~     metformin SR 750mg, in healthy volunteers.~   "
90817|NCT02378428|"~     This is a Phase II study for patients with MIBG avid tumors. The study is to determine the~     response rate to <131>I-MIBG in patients with de novo, relapsed or refractory neuroblastoma~     or other MIBG avid malignant tumors 42 days post MIBG therapy. It will also be evaluating the~     tolerability and safety of the study agent by evaluating the hematopoietic and~     non-hematopoietic toxicity of <131>I-MIBG therapy. Tumor response will be evaluated by~     comparing the patient's disease pre-treatment against the patient's day +42 post <131>I-MIBG~     treatment. The evaluations may include the following: <131>I-MIBG scan, CT or MRI, urine~     catecholamine, bone marrow analyses and any other tests considered standard of care for~     cancer evaluation. To be eligible for participation, patients must have tumors that are MIBG~     avid. Patients must also have a stem cell source for autologous rescue in the event of~     protracted therapy associated cytopenias. Peripheral stem cell collections are preferred as~     the hematopoietic cell source. Bone marrow harvests for a hematopoietic cell source is an~     alternative. This study will provide data for future clinical trials utilizing <131>I-MIBG~     therapies. A room on H12 has been prepared with lead lined walls, and many radiation safety~     components to accomodate this treatment. <131>I metaiodobenzlguanidine (<131>I-MIBG) is a~     radiopharmaceutical that concentrates within adrenomedullary tissue. The agent was initially~     used for tumor imaging due to its capability to locate pheochromocytomas, neuroblastomas and~     other neuroendocrine tumors. <131>I-MIBG was subsequently used as an therapeutic agent for~     these tumor types. Phase I and II therapeutic trials targeting neuroblastoma have reported~     response rates of 10-50%. Toxicities observed have been mainly hematopoietic, with ~50% of~     patients receiving 15mCi/kg requiring stem cell reinfusion. Observed non-hematopoietic~     toxicities have been mild. Most recently, trials have been conducted combining the study~     agent with myeloablative chemotherapy and stem cell reinfusion have been performed with~     initial response rates of ~50%.~   "
90818|NCT02378415|"~     The objective of this double-blinded placebo-controlled pilot study is to determine whether a~     single sub-anesthetic rapid IV bolus dose of ketamine administered to acutely depressed~     patients with or without suicidality has a significant rapid antidepressant effect in the~     acutely depressed population. The study will pursue as a primary outcome measure whether a~     significant reduction in depressive symptoms, as assessed by the BSS and BHS, occurs shortly~     after administration of ketamine at 40, 80, 120, and 240 minutes. A secondary outcome measure~     will be assessed to determine whether this single infusion of ketamine has a sustained~     reduction in depressive symptoms within 2-weeks post-infusion with a reduction in BDI score.~     Suicidal ideation will also be assessed for determination of any reduction and sustained~     reduction post infusion by assessment of the Beck Suicidal Ideation Scale (BSS), Beck~     Hopelessness Scale (BHS) and Beck Depression Inventory (BDI) at similar intervals.~   "
90819|NCT02378402|"~     The objective of this 3-year project is to develop myocardial MRS, in particular lipid~     (triglyceride) and creatine resonances, as imaging biomarkers for patients with heart failure~     (HF). Investigators will elucidate how and, to what extent, lipid and creatine levels of the~     heart contribute to heart failure. The first year is a cross-sectional study. Investigators~     aim to compare the MRS of normal subjects and that of stable HF patients in recovery with~     normal or impaired ejection fraction (EF). Total 60 subjects will be enrolled, with 20~     subjects in each group. In the 2nd and 3rd years, investigators plan a prospective~     longitudinal study of 40 subjects. Enrolled patients will be evaluated with cardiac MRS at~     three time points, i.e., disease onset, 6 months and one year after treatment, and will be~     followed up until the end of this project (1.5~3-year follow up). In total 120 MR scans will~     be performed in the 2nd and 3rd years. The resonances from cardiac MRS, including creatine~     and lipids, will be correlated with the disease course, patient biochemistry data and~     clinical outcome. Investigators expect to make MRS to become an integral part of a clinical~     cardiac MR protocol.~   "
90820|NCT02378389|"~     Pyrotinib is an oral tyrosine kinase inhibitor targeting both EGFR and HER-2 receptors. This~     study is designed to evaluate the safety and tolerability of Pyrotinib or Pyrotinib in~     combination with Docetaxel in patients with HER2 positive advanced gastric cancer.~   "
90821|NCT02378376|"~     During this project the amount of SCFA produced in the colon after consumption of 2 different~     13C-labelled wheat fiber fractions will be quantified.~   "
90822|NCT02378363|"~     The main objective is to develop an educational program and to measure the impact on social~     representations identified as acting in the prevention of cancer. Child should write, draw~     and speak about cancer signifiance to identify individual conceptions and representations of~     health and cancer in children aged 9 to 12 years in school.~   "
90823|NCT02378350|"~     This is a multicenter, randomized, open-label study to compare QoL in subjects with end-stage~     renal disease (ESRD) requiring PD or conventional in-center HD treatment.~      Primary Objective: The primary objective is to demonstrate non-inferiority of peritoneal~     dialysis (PD) treatment as compared to hemodialysis (HD) treatment after approximately 1 year~     of therapy using the Kidney Disease Quality of Life-Short Form (KDQoL-SF) questionnaire~     domain of burden of kidney disease.~      Secondary Objectives: The secondary objectives are to observe and summarize the following~     parameters in subjects receiving PD or HD treatment except for the remaining domains of QoL~     instrument KDQoL-SF™ (version 1.3) and the 2 individual QoL items scored as single items,~     which will be compared between the 2 treatment groups:~        -  Mortality rates~        -  Switch (PD to HD or HD to PD)~        -  Transplantation rate~        -  Cause of death~        -  Dialysis adequacy (ie, urea clearance time normalized by total body water, which is the~          volume of distribution of urea [Kt/V urea] to determine the proportion of subjects~          meeting standards of care for dialysis adequacy).~        -  24-hour urine volume~        -  Change in hemoglobin and S-phosphate levels, and the percentages of subjects with values~          within the target range~        -  Change in serum albumin~        -  Frequency of adverse events (AEs) and serious AEs (SAEs), including abnormal laboratory~          test findings with clinical significance~   "
90824|NCT02378337|"~     Identify the best combination of predictive variables that influence ionizing radiation dose~     and improved image quality through analysis and quantification of PET-CT images in simulators~     and patients.~   "
94067|NCT02335879|"~     The purpose of this study is to evaluate the efficacy and safety of Domestic Recombinant~     Human Follitropin (Gonal-F) for Injection for treatment of WHO Ⅱ anovulation (including~     polycystic ovarian syndrome [PCOS] subjects).~   "
90825|NCT02378324|"~     Several reasons can explain non-attendance in cervical cancer screening. In low resource~     settings the attendance is even lower. The effect of fee as contributing reason of non~     attendance has not been studied before why the investigators decided to study this in a low~     resource setting as a randomised trial.~   "
90826|NCT02378311|"~     Cycling injuries are the 3rd most common mechanism of injury in 7-13 year olds[1]. Bicycle~     injuries have remained one of the commonest causes of paediatric abdominal trauma for over 60~     years[2,3]. 15% of child cyclist injuries involve impact with a handlebar; two-thirds of~     those are abdominal injuries[4]. Handlebar impact is now the commonest mechanism of major~     paediatric abdominal injury[3]. Serious handlebar injuries often occur after apparently minor~     falls; they are not unique to riders performing stunts[5].~      One small study found that the metal handlebar ends were often exposed on bikes of children~     sustaining severe abdominal injuries[6]. Most European safety standards do not test grip~     durability[7-10]. Day-to-day use can damage rubber grips, exposing the underlying metal~     handlebar tube.~      This feasibility study aims to test the research methods that will be used in a subsequent~     nationwide multicentre study. The main study will investigate the association between~     injuries and handlebar grip condition.~      Children attending study hospitals with any bicycle or kick scooter injury will be invited to~     participate. Parents of injured children will be invited to complete questionnaires regarding~     circumstances surrounding the injury and condition of the handlebar ends on the bike or~     scooter involved. Clinical information regarding the injury will also be collected. The~     handlebar end condition will be compared between children sustaining a handlebar end injury~     [Cases] and riders whose injury did not involve the handlebar [Controls].~      If exposed handlebar ends are more prevalent amongst riders with handlebar end injuries,~     injury prevention strategies can focus on methods to prevent damage occurring to grips~     through day-to-day use. If no such association is found, prevention strategies can be focused~     elsewhere, such as on design of effective protective clothing.~      Data collection for this feasibility study will occur between March 2015 and September 2015.~      The Chief Investigator, Mr. Andrew Neilson, funds the feasibility study.~   "
90827|NCT02378298|"~     Thyroid Associated Ophthalmopathy is condition affecting the eyes of about 10% of patients~     with Graves disease. Its combination of protrusion affecting the looks of the patient and~     pain is often severely affecting the quality of life among these patients.~      The standard treatment for this illness today is intravenous glucocorticoids together with~     methotrexate. The purpose of this study is to evaluate the effect of rituximab on patients~     that do not respond to or relapse after conventional therapy.~   "
90828|NCT02378285|"~     The purpose of this study is to assess efficacy of two intra-tendinous injections of~     platelet-rich plasma (PRP) on epicondylitis of recent evolution (≤ 3 months) compared~     compared to two intra-tendinous injections of saline solution (placebo).~   "
90829|NCT02378272|"~     The aim of the project is to explore if a complementary addition of a care manager for~     depression treatment in the primary care setting has positive effects concerning reduction of~     the patients' depressive symptoms as well as improvement of daily function and quality of~     life in a short- and long-term perspective compared with the traditional Swedish primary care~     organization. The aim is also to evaluate the care manager function in a health economic~     perspective.~      The specific aims are to develop and evaluate an evidence-based care manager program for~     patients with mild to moderate depression and to compare the evidence-based care manager~     program to treatment as usual (TAU) in terms of their short- and long-term effects on symptom~     remission, treatment adherence, care satisfaction, and self-efficacy as well as to perform a~     cost - effectiveness analysis of the care manager program, i.e. to evaluate the effects of~     the program on patients' health in relation to the running costs of the program.~   "
90830|NCT02378259|"~     Severe childhood obesity is associated with both immediate and chronic health problems and a~     severe impact on psychosocial development. Medical and behavioural interventions rarely~     result in the significant, durable weight loss necessary to improve health outcomes.~      This is a randomised clinical trial where 50 adolescents, 13-16 years of age, will be~     randomised to either early bariatric surgery (Roux-en-Y gastric bypass) or intense~     conservative treatment and possibly surgery as they have become 18 years.~   "
90831|NCT02378246|"~     THE ULTIMATE GOAL of this project is to answer the question In MILD IODINE DEFICIENCY (ID),~     should 150 μg iodine/day be administered to pregnant women with a normal diet, to attain a~     normal cognitive development of the fetus or is there no cognitive deficit from mild ID and~     no extra iodine is needed?. To answer this question, the investigators planned a randomized,~     placebo-controlled trial of iodine supplementation during pregnancy in Sweden (SWIDDICH) with~     the follow-up of childrens' COGNITIVE DEVELOPMENT at 18 months, 3.5, 7 and 14 years.~      Iodine deficiency (ID) is associated with thyroid morbidity and, especially in children, with~     impaired cognitive development. Sweden introduced iodine fortification of table salt 1936 and~     mental retardation due to severe ID is eradicated. Is mild ID during pregnancy also~     eradicated? If not, is this of importance? A national study performed by the investigators in~     2007 showed iodine sufficiency in general population, but there are no pregnancy data. Local~     studies have raised concerns for mild ID during pregnancy in Sweden and a trans-sectional~     national study is currently ongoing.~      The burning question for Sweden and the whole world is: is mild ID during pregnancy of~     importance for the developing brain of the fetus? Two large observational studies have shown~     association between mild ID during pregnancy and lower verbal IQ or educational performance~     at school-aged children. The world needs a randomized placebo-controlled trial (RTC)~     comparing the cognitive outcome in children exposed to mild ID during fetal life with~     children exposed to normal iodine levels during fetal life.~      Our HYPOTHESIS is that pregnant women in Sweden have mild ID and that children exposed to~     mild ID during fetal life have a lower cognitive development, compared to children to mothers~     taking 150 ug iodine supplementation during pregnancy.~      The MAIN AIM of the SWIDDICH trial is to determine if children exposed to mild iodine~     deficiency (ID) during fetal life achieve worse cognitive development compared to children~     exposed to normal iodine status reached by maternal iodine supplementation.~   "
90832|NCT02378233|"~     The aim of the study is to measure urinary milk iodine concentration (MIC), iodine~     concentration (UIC), thyroid hormones (TSH, FT4) and thyroperoxidase antibodies (TPOab) in~     breast-feeding women, and UIC in their nursing infants to determine if the levels are~     adequate, and to see how they can be influenced by 150 ug daily iodine supplementation in~     breast-feeding women. The hypothesis is that there is a relative iodine deficiency in this~     sub-population - lactating women and nursing children-, and that this can be influenced by~     iodine supplementation. Adequate thyroid hormone and iodine levels are very important for~     small children, when the plasticity of the brain is greatest.~      This is as a prospective, double-blind, placebo-controlled study of 221 mothers and their~     infants. In parallel, 90 age-matched healthy non-pregnant women are recruited. Mothers are~     randomized to 150 µg/day iodide supplementation or placebo.~      Pregnant women are asked for participation on a visit in pregnancy week 37, at the mother~     health care (MVC) at Mölnlycke and Skövde. The study will run for approximately 3 months for~     each individual and begins by sampling A (UIC, TSH, FT4, TPOab) at week 37 of the pregnancy,~     when mothers also get randomized to 150 µg iodine or placebo. New sampling B (UIC, TSH, FT4,~     MIC ) is collected when the baby is 3 months old. Thereafter the study is completed. In~     parallel, 90 healthy non-pregnant, non-lactating women in the same age range are recruited~     and followed with UIC, TSH, FT4, TPOab for 6 months as a control group. In each case a simple~     questionnaire is filled and blood is also frozen for future analyses.~   "
90859|NCT02377882|"~     The investigators tried to explore an alternative non-depolarizing muscle relaxant~     (rocuronium) and its optimal dosage to replace succinylcholine for IONM during thyroid~     surgery.Time frame of outcome measure was during 30 to 70min after rocuronium injection.~     Specific time points at which the will be assessed and for EMG signals will be presented.~   "
90833|NCT02378220|"~     Patients meeting eligibility criteria will be randomized into two groups, one receiving~     pharmacogenetic testing and the other not receiving pharmacogenetic testing. In this~     open-label trial, a pharmacist will make medication therapy recommendations using YouScript®~     Personalized Prescribing System for patients who receive genetic testing and standard drug~     information resources per usual for patients who do not undergo pharmacogenetic testing.~   "
90834|NCT02378207|"~     The aims of the phase 1b trial described here are to facilitate identification of assays and~     immune responses that could then be evaluated as correlates of risk and correlates of~     protection in efficacy studies and ultimately to provide leads for biomarkers of protection~     against tuberculosis. This study will complement one ongoing study (NCT02075203) evaluating~     the prevention of M. Tuberculosis infection using H4:IC31 (also known as AERAS-404).~   "
90835|NCT02378194|"~     Chronic renal failure is a syndrome that renal function is decreased, and the patient number~     is increasing. In addition, patients on dialysis have also increased. Depending on the~     chronic renal failure aggravated, the deterioration of life caused by the conduct of dialysis~     patients is caused. In addition, a problem in dialysis treatment is ongoing economic burden~     surface to increase the life of the patient and family. A solution to this problem is, or~     stops the progression of chronic renal failure prior to dialysis, it is necessary to delay.~     As a treatment for inhibiting the progression of chronic renal failure is present, along with~     diet and blood pressure-lowering drugs or a drug therapy used by kremezin. However, the~     effect is not enough, new drug development is required.~      HD-003 is a novel compound, and found to inhibit the renal failure progression. It was found~     during the search active substance that appear when the inflammation in animals. The~     investigators confirmed that the substance is present in the urine of a person during the~     study, and later established a link between kidney disease hypotheses. When performing the~     test in animal model renal failure, chronic renal Through the non-clinical testing of the~     HD-003(general toxicity studies, reproductive, developmental toxicity test, mutagenicity test~     and antigen tests) showed that a very low toxicity. When going through the review of the~     safety and pharmacokinetic Phase 1 clinical study, it was confirmed a very satisfactory~     safety and tolerability. And pharmacokinetic results from the body's absorption in healthy~     subjects had been done well, a linear correlation was observed. Finally, it was confirmed~     that the most rapidly excreted into the urine.~      This study is a Phase 2a clinical trials performed in patients with chronic renal failure in~     3, 4 steps. The evaluation of changes in serum creatinine(sCr) in vivo indicator of renal~     failure according to the progress. Evaluating the inhibitory effect of HD-003 renal failure~     progression and dose setting, and to determine the safety.~   "
90836|NCT02378181|"~     This study deploys a strategy to develop and evaluate a training-efficient, multimedia~     patient-centered Health Education Toolkit to promote shared decision making between~     counselors and patients. An existing evidence-based toolkit intervention will be adapted and~     redesigned by a patient and provider team into an engaging, narrative graphic novel~     curriculum useful in group and individual counseling. The proven behavioral interventions~     will be augmented with health education material focused on medication assisted treatment~     (MAT). We will assess feasibility and acceptability, and pilot test whether exposure to the~     Toolkit (TK) can shared decision making conversations, reduce substance use, and increase~     engagement with MAT.~   "
90837|NCT02378168|"~     Retrospective analysis of a 6-month follow up within a randomised controlled study in cardiac~     surgery with pharmacological postconditioning (sedation on intensive care unit with~     sevoflurane)~   "
90838|NCT02378155|"~     Near infrared spectroscopy (NIRS) is a technique that measures regional cerebral oxygenation~     in a non-invasive manner. Through the use of near infrared light, the difference between~     oxygenated and deoxygenated hemoglobin can be measured. By applying the Lambert-Beer law, a~     numeric result can be calculated.~      Since atrial fibrillation (AF) has been linked with an increased risk for the development of~     neurocognitive deficits, a longer period of AF might be associated with a higher risk for~     neurocognitive deficits.~      It is hypothesized that there is an increase in the regional cerebral oxygen saturation~     (rSO2) of patients with paroxysmal or persistent AF after successful cardioversion.~   "
90839|NCT02378142|"~     The purpose of this study is to test any good and bad effects of the study drug pazopanib.~   "
90840|NCT02378129|"~     The aim of this randomized, double-blind, split-mouth clinical trial is to evaluate and~     compare the desensitizing efficacies of the resin-modified glass ionomer cement ClinproTM XT~     (3M ESPE, Minnesota, USA) and the conventional glass ionomer cement Vidrion R (SS White,~     Gloucester, UK) at 2-year follow-up.~   "
90841|NCT02378116|"~     Because atrial fibrillation occurs frequently in heart surgery patients, our overall~     hypothesis is that systematic closing the left atrial appendage during surgery will reduce~     cerebral embolism coming from the thrombus formation in the left atrium.~      The specific hypothesis which sought tested is that closure of the left atrial appendage in~     connection with elective CABG and / or valve surgery will lead to fewer strokes and micro~     cerebral infarcts measured by MRI.~   "
90842|NCT02378103|"~     To evaluate epidemiological features of risk factors for aortic dissection (AD) in Chinese~     XinJiang Province patients.~   "
90843|NCT02378090|"~     The purpose of this observational study is to characterize individuals in Mexico who seek~     medical care for influenza-like illness (ILI) and Severe Acute Respiratory Infection (SARI),~     describe seasonal pattern of the pathological agents associated with ILI and SARI and to~     identify changes in severity of disease caused by a specific agent.~   "
90844|NCT02378077|"~     This study is being done to better understand the relationship between inflammation and~     insulin resistance in your Adipose (fat) Tissue .~   "
90845|NCT02378064|"~     The purpose of this study is to evaluate the effects of angiotensin receptor 1 blocker versus~     calcium channel blocker on atherosclerotic plaque inflammation using serial FDG PET/CT~     imaging of carotid artery.~   "
90860|NCT02377869|"~     Recently, a novel assay for detecting heavy/light chain (HLC) ratios has been reported which~     enables improvement in paraprotein detection and monitoring in multiple myeloma and other~     plasma-cell dyscrasias.~      The prognostic and biological role of the HLC assay has as yet not been studied in CLL.~      Aims of the proposed study:~        1. To quantify and analyze the prognostic significance of HLC ratios in the serum of CLL~          patients. (In addition to FLC)~        2. To study the different patterns of Immunoglobulin's subclass antibodies in the serum of~          patients with CLL and compare them to those of to healthy volunteers.~        3. To perform a sub-analysis in patients with CLL who have autoimmune phenomenon (AIHA and~          ITP)~   "
90861|NCT02377856|"~     Patients with acute hepatitis C virus (HCV) infection usually become chronicity if viremia~     persists after 6 months of infection. The result of using pegylated interferon plus ribavirin~     combination therapy upon these patients remains to be explored~   "
93678|NCT02340962|"~     A Phase 2, Multicenter, Randomized, Open-label, Dose-ranging Study to Evaluate the Efficacy~     and Safety of TG-2349 in Combination with Peg-interferon and Ribavirin in Treatment Naïve~     East Asian Subjects with Chronic Hepatitis C Virus Genotype 1b Infection.~   "
90846|NCT02378051|"~     The purpose of this study is to examine whether Staying Strong With Schools, a school-based~     intervention to support military-connected children, will be helpful for school professionals~     and military parents in supporting specific needs of this population of children. As part of~     the partnership between three school districts in Massachusetts and the Red Sox Foundation~     and Massachusetts General Hospital Home Base Program, the investigators will examine the~     efficacy of a training delivered to these schools. The schools will be randomly divided into~     two groups (like a toss of a coin). Half of the schools will receive the training in~     2014-2015, and the other half will be waitlisted and receive the training the following year~     (2015-2016). All participants (school teachers, military-connected children, and their~     parents) will be asked to complete questionnaires the first year. The investigators~     hypothesize that, compared to the control schools, at the end of the school year, SSWS~     schools will be associated with: (1) greater sense of competence and quality of relationships~     with military-connected children (MCC) among school professionals; (2) lower parental~     distress and increased parental sense of competence and general family functioning; and (3)~     increased social support, and fewer academic, emotional, and behavioral problems among MCC.~     The investigators hypothesize that an increase in school professionals' sense of competence~     in identifying and handling MCC's needs, increased quality of relationships with MCC, lower~     parental distress, increased parental sense of competence, and increased general family~     functioning will mediate the efficacy of SSWS on MCC's social support and psychosocial~     functioning.~   "
90847|NCT02378038|"~     This study is sponsored by Sierra Oncology, Inc. formerly ProNAi Therapeutics, Inc. It is a~     multi-center, single-arm, 2-stage, open-label phase II investigation of PNT2258 to~     characterize anti-tumor activity and collect safety data on patients with Richter's~     Transformation.~   "
90848|NCT02378025|"~     The purpose of this study is to determine whether yoga is effective for the treatment of~     chronic pain in Gulf War Illness.~   "
90849|NCT02378012|"~     This randomized clinical trial studies iPad use in reducing anxiety and depression in~     patients undergoing bone marrow transplant. A tablet device like the iPad can provide access~     to music, television, movies, books, and the Internet. It also contains a video conferencing~     system that can allow patients to communicate with family members and other members of their~     social support team. With these capabilities, an iPad distribution program may help lessen~     patient anxiety and depression during a hospital stay. Monitoring iPad use by patients may~     help doctors better understand how patients use their computers and tablets while in the~     hospital so that the software and applications of the iPad can be made more useful.~   "
90850|NCT02377999|"~     An exploratory open label, single treatment trial of anogenital warts with Picato® repeated~     up to 2 times with two weeks intervals.~   "
90851|NCT02377986|"~     Patients participate in Buried in Treasures Workshop (BIT) that has been shown to improve~     symptoms of hoarding disorder. To target levels of clutter, the investigators are testing an~     intervention to add in-home decluttering practice to the BIT workshop.~   "
90852|NCT02377973|"~     The overall aim is to provide a detailed description of growth, development and risk factors~     for later disease, especially obesity and metabolic disease in infants born by obese mothers~     and to compare them with a group of infants born by mothers without any restriction in~     prepregnancy BMI (SKOT I).~   "
90853|NCT02377960|"~     The purpose of this pragmatic multi-centre, cluster randomized controlled trial is to test~     the effectiveness of tailored SMS-text message support combined with an~     information-motivation-behavioral skills (IMB) model-based initiation of medication in~     helping outpatient care patients with hypertension to achieve blood pressure target and to~     enhance medication adherence.~   "
90854|NCT02377947|"~     This is a retrospective study in adult patients with cirrhosis and grade 3 or 4 HE (West~     Haven Criteria) to evaluate the effectiveness and safety of lactulose retention enema in the~     treatment of deep grade HE (West Haven Criteria). The study will be conducted retrospectively~     in a single center of a multispecialty tertiary care hospital in India, in which lactulose~     retention enema is the mainstay of management of cirrhotic patients with grade 3 or 4 HE~     (West Haven criteria). Dosing of lactulose retention enema in this study will be done~     according to the dosing described for rectal administration of lactulose (India): 300ml of~     lactulose mixed with 700ml of potable water to be used as a retention enema; the enema is to~     be retained for 30-60 minutes and repeated every 4-6 hours until the patient is able to take~     oral medication. This treatment regime is also the standard protocol of management of deep~     grade HE (West Haven criteria) in the study center. The standard treatment protocol of deep~     grade HE (West Haven criteria) of the study center will also ensure that all known~     contraindications of lactulose will be respected before administration of lactulose retention~     enema to the study patients. The retrospective hospital records of the patient population of~     interest within the past 6 months will be identified, and these records will be used to~     collect data required for analysis.~   "
90855|NCT02377934|"~     In the radiotherapeutic treatment of lung cancer, the dose that can be safely applied to the~     tumour is limited by the risk of radiation induced lung damage. This damage is characterized~     by parenchymal damage and vascular damage. In rats, we have found that radiation-induced~     vascular damage results in increased pulmonary artery pressure. Interestingly, the consequent~     loss of pulmonary function could be fully explained by this increase in pulmonary artery~     pressure. We hypothesize that also in patients a radiation induced increase in pulmonary~     artery pressure can be observed after radiotherapy, which may contribute to the development~     of radiation pneumonitis.~      The objective is to test the hypothesis that radiotherapy for lung cancer induces an increase~     in pulmonary artery pressure.~   "
90856|NCT02377921|"~     UX001-CL301 is a randomized, double-blind, placebo-controlled study to assess the safety and~     efficacy of 6 g/day sialic acid - extended release (SA-ER) treatment as compared with placebo~     in subjects with GNE Myopathy.~   "
90857|NCT02377908|"~     The objective of the study is to give a structured update on geriatric postgraduate education~     throughout Europe. The study will be performed as a cross-sectional structured quantitative~     online survey with qualitative comments. The survey content covers structural items, content~     and educational aspects of geriatric specialty training in European countries.~   "
90858|NCT02377895|"~     Single-center, double-masked, randomized, placebo-controlled, parallel-group, efficacy and~     safety study using the Allergen BioCube (ABC).~   "
90862|NCT02377843|"~     Coverage of HPV vaccination among US teens is low, far below Healthy People 2020 goals. A~     central reason for low coverage is infrequent and inadequate healthcare provider~     recommendation of HPV vaccine. The proposed intervention aims to train clinicians to provide~     effective recommendations for the vaccine using participatory or efficient communication~     strategies.~      This study will evaluate the effectiveness of two communication trainings to increase HPV~     vaccination coverage among adolescent patients. We will compare HPV vaccination for pediatric~     and family medicine clinics receiving a participatory communication training, efficient~     communication training, or no training. Ten clinics will be randomly assigned to each study~     arm for a total of 30 clinics. The primary outcome of this study is to compare the change in~     clinics' levels of HPV vaccination initiation coverage among 11-12 year old adolescent~     patients from baseline to 6 month follow-up. Secondarily, we will compare the change in HPV~     vaccination initiation coverage in 13-17 year old adolescents.~   "
90863|NCT02377830|"~     Background: Patients in the intensive care unit (ICU) are the sickest in hospital, and need~     advanced life-support. Survivors of critical illness are very weak and disabled. Up to 1 in 4~     have severe leg weakness impairing their quality of life for as long as 5 years after ICU~     discharge. In-bed cycling involves use of special equipment that attaches to a patient's~     hospital bed, allowing them gentle exercise while in the ICU.~      Methods: Adult patients admitted to the ICU who need a breathing machine and are expected to~     survive their ICU stay are eligible. Patients will randomly receive 30 minutes of in-bed~     cycling each day they are in the ICU or routine physiotherapy, both delivered by specially~     trained physiotherapists.~      Outcomes: Feasibility: The investigators will study whether patients can cycle on most days~     of their ICU stay, whether patients and their families agree to be a part of the study, and~     whether investigators can systematically assess patients' strength.~      Relevance: Effective methods of physiotherapy are needed for critically ill patients to~     minimize muscle weakness, speed recovery, and improve quality of life. This pilot randomized~     study is the second of several future larger studies about in-bed cycling in the ICU.~   "
90864|NCT02377817|"~     Back and right-sided sleeping position in pregnant women has recently emerged as a potential~     risk factor for low birthweight (LBW) and stillbirth (SB) in the medical literature. Assuming~     that sleep position in pregnant women is modifiable, the same literature has indicated that~     this risk factor is modifiable; however, there is no evidence that this risk factor is truly~     modifiable.~      The proposed link between back and right-sided sleeping position in a pregnant woman and LBW~     and SB of her baby is multifactorial; however, it ultimately implicates the woman's body~     position in causing compression of one of the large veins that brings blood back to her~     heart. This compression, along with other factors relating to the woman, her placenta, and~     her developing fetus, may result in decreased blood flow (nutrition and oxygen) to her~     developing baby, which, depending on the extent and duration, could result in LBW or SB of~     her baby. If the back sleeping position during pregnancy has a causative role in LBW and~     subsequently SB, the literature indicates that up to 17% of LBW and consequently 26% of SB~     could potentially be prevented by changing position to avoid back sleep. Note that 20 million~     LBW and 2.6 million SB occur each year worldwide.~      Positional therapy (PT) is a safe and effective intervention for preventing people who snore~     or people who's breathing pauses during sleep from sleeping on their back - a position that~     makes their condition worse. The most basic form of PT modifies a person's sleeping position~     by either:~        -  Preventing them from sleeping on their back through restricting their movement, or~        -  Rather than restricting movement, significantly reducing the amount of time they spend~          sleeping on their back by applying pressure points to their body while they are on their~          back, which eventually causes them to shift into a different position and avoid lying on~          their back.~      The purpose of this study is to evaluate the ability of a PT intervention to modify the~     position of pregnant women from their back and right side to their left side while they sleep~     in late pregnancy.~      This study will help determine whether this potential risk factor is modifiable by way of a~     PT intervention, and whether it is feasible to intervene to reduce or prevent back and~     right-sided position sleep in late pregnancy. Demonstrating that the sleeping position of~     pregnant women can be modified through use of a simple, inexpensive PT intervention may be~     one of the keys to achieving significant reductions in LBW and late SB rates in Canada and~     worldwide.~   "
90865|NCT02377804|"~     Stroke is the leading cause of physical disability due to the presence of spasticity.~     Different needling techniques, including Botulinum Toxin A are proposed for management of~     spasticity; however results are conflicting. The presence of spasticity in the upper~     extremity implies several impairments for daily life activities. No study has investigated~     the effects of deep dry needling inserted into the targeted spastic musculature of the~     shoulder region in patients who had suffered a stroke. The investigators will conduct a~     randomized controlled trial investigating the effects of the inclusion of deep dry needling~     into a rehabilitation program over the musculature of the shoulder region, pressure pain~     hyperalgesia and range of motion in individuals with chronic stroke. The investigators~     hypothesize that patients receiving dry needling into the spastic shoulder musculature would~     exhibit greater improvements in spasticity, pressure sensitivity and range of motion than~     those who will not receive the intervention.~   "
90866|NCT02377791|"~     Tacrolimus is a drug used commonly in kidney transplant patients to prevent graft rejection.~     Tacrolimus acts in a very narrow range in the blood for its optimum activity. If the levels~     are too high, there is a risk of kidney injury, whereas, if the levels are too low there is a~     higher risk of rejection and graft loss. Genetic differences in the gene coding for the~     enzyme cytochrome P450 (CYP3A5), which is responsible for breaking down active tacrolimus can~     contribute to variations in blood levels of tacrolimus among different individuals taking the~     same dose of the drug. Certain genetic types lead to low concentrations, whereas certain~     genetic types can lead to high levels. The proportion of individuals with different types of~     genetic variations differ among different ethnic populations. Limited data are available in~     Thai subjects or on the risk have having certain types of genetic variations on the risk of~     rejection.~      This study aims to compare the effects of different types of CYP3A5 gene variations on~     Tacrolimus drug levels and risk of acute rejection in Thais.~   "
90867|NCT02377778|"~     In this study the aim is to compare the effect of the type of anaesthetic drug used during~     oocyte retrieval on fertilization rates of oocytes retrieved after ovarian stimulation for~     in-vitro fertilization.~   "
90868|NCT02377765|"~     This study will help to determine the effectiveness of a self-supervised, home-based~     Transcutaneous Posterior Tibial Nerve Stimulation treatment protocol in maintaining~     Overactive Bladder (OAB) symptoms improvement in women responders to Posterior Tibial Nerve~     Stimulation (PTNS)~   "
90869|NCT02377752|"~     This study consists of 2 parts (Part A and Part B). The main purpose of Part A is to evaluate~     safety and side effects of olaratumab in combination with doxorubicin in Japanese~     participants with a group of rare cancers (advanced solid tumors, especially advanced soft~     tissue sarcoma [STS].) The main purpose of Part B is to evaluate how much olaratumab gets~     into the blood stream of Japanese participants with advanced solid tumors and how long it~     takes the body to get rid of it.~   "
90904|NCT02377297|"~     The aim of this study is to evaluate the survival rate and the cost-effectiveness of~     occlusal-ART restorations using three GIC brands (Fuji IX, GC Europe; Maxxion R, FGM; Vitro~     Molar, DFL) in primary molars.~   "
90870|NCT02377739|"~     The efficiency of non-invasive ventilation (NIV) in hypercapnic patients with chronic~     obstructive pulmonary disease during pulmonary rehabilitation has been shown in numerous~     studies. There is only a limited number of therapeutic options for patients with severely~     progressed interstitial lung disease (ILD). The question whether chronic hypercapnic~     ILD-patients are able to profit from nocturnal NIV and thus increase their performance in~     physical training has been left unknown. Therefore, this study aims to evaluate the~     feasibility of the initialization of a NIV for hypercapnic ILD-patients during pulmonary~     rehabilitation.~   "
90871|NCT02377726|"~     Internet based self help program with or without support of a counselor is tested among~     anonymous Internet help seekers at an open access website.~   "
90872|NCT02377713|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of~     KHK6640, given as a single dose in Japanese patients with Mild to Moderate Alzheimer's~     Disease.~   "
90873|NCT02377700|"~     Xeltis developed biodegradable patch prosthesis, the Vascular Patch Model COR-VP-001, to be~     used as a vascular patch to augment the pulmonary trunk and pulmonary arteries. The~     prosthesis is immediately mechanically functional, while its physiochemical characteristics~     should enable cell infiltration and tissue formation.~      The Xeltis Vascular Graft Model COR-VP-001 is specifically designed to improve surgical~     outcomes by reducing synthetic material related complications and improving hemodynamic~     characteristics.~   "
90874|NCT02377687|"~     To study the impact of emergency high risk GI surgery on HRQOL in elderly patients,~     seventy-five years or above and to explore the patients' experience with the informed consent~     process and the status 6 months after surgery.~   "
90875|NCT02377674|"~     The extracardiac Fontan surgery/procedure involves diverting the venous blood from the~     inferior vena cava to the pulmonary arteries without passing through the morphologic right~     ventricle. In the extracardiac conduit type of Fontan, one end of a synthetic tube graft is~     connected to the inferior vena cava and the other end to the pulmonary artery confluence.~      Xeltis developed a biodegradable prosthesis, the Xeltis Vascular Graft Model COR-VG-001, to~     be used as an extracardiac conduit between right atrium and the pulmonary arteries. The~     prosthesis is immediately mechanically functional, while its physiochemical characteristics~     should enable cell infiltration and tissue formation.~      The Xeltis Vascular Graft Model COR-VG-OO is specifically designed to enhance the Fontan~     surgery outcome by reducing synthetic material related complications and improving~     hemodynamic characteristics.~   "
90876|NCT02377661|"~     The aim of this prospective, randomised, open-label, multicentre clinical trial is to enhance~     blood pressure control in primary care by introducing a standardised and simplified titration~     regime with single pill combinations (SPC), comprising an angiotensin receptor blocker,~     calcium channel blocker and hydrochlorothiazide.~   "
90877|NCT02377648|"~     The CART Pilot study was designed to provide preliminary observations (about performance and~     safety) and generate hypotheses for future studies . The primary goal of the study is to~     evaluate the performance at one year of second-generation ABSORB Bioresorbable Vascular~     Scaffold (BVS)(Abbott Vascular, Santa Clara, CA , USA), the Everolimus Eluting Bioresorbable~     Vascular Scaffold, in heart transplant recipients affected by cardiac allograft vasculopathy~     (CAV) and significative coronary stenosis.~      The secondary objectives are:~        -  to collect data about the procedural and clinical outcomes post-procedure , 30 days, 180~          days and at 1,2 and 3-year follow-up, of patients who underwent ABSORB BVS implantation~          in order to investigate the safety of the device in CAV population;~        -  to evaluate the progression of the disease and the its interactions with the study~          device by using data derived from multi-imaging invasive techniques.~      The vascular reparative therapy and in particular the BVS technology showing important~     advantages in terms of endothelial preservation, adequate vasomotion, and restoration of the~     media and adventitia of the vessel wall, could represent a new and more effective therapeutic~     option, compared to bare-metal and drug-eluting stent technologies, for transplanted~     patients, since all these mechanisms may, at least in part, counteract the detrimental~     changes leading to CAV, namely constrictive remodeling and rapid atherosclerosis progression.~      Subjects enrolled into the clinical study will be male or female derived from the heart~     transplant recipients population of every participating center. The clinical study will~     enroll 30 subjects. Subjects, who underwent the yearly expected coronary angiography~     follow-up after heart transplant surgery, meeting the general and angiographic inclusion and~     exclusion criteria (eligibility will be assessed by Heart Team consensus) will be asked to~     sign an informed consent form. Subjects who do not meet inclusion and exclusion criteria are~     subject to the standard follow-up of heart transplant (HTx) recipients and will undergo to an~     invasive evaluation after 365 ± 28 days.~      The study comprises two distinct phases:~        -  the enrollment phase which starts with the recruitment of the first subject and it is~          planned to last one year;~        -  the follow-up phase which is planned to last three years from the enrollment of the last~          patient.~      The total duration of the study will be of four years, including both the enrollment and the~     follow-up phases~   "
90878|NCT02377635|"~     This clinical trial should prove that selenium can treat arsenic exposure in humans by~     promoting excretion. The new trial differs from previous trials in that participants will be~     maintained in a local clinic and provided with food and water from their home villages. The~     purpose of this study to determine the fate of selenium supplements in feces, urine and blood~     of volunteers living in conditions of high arsenic load in drinking water. The use of a~     clinic will enable monitoring of all intake and excretion of both arsenic and selenium, and~     will ensure that participants take their selenium doses or placebo as appropriate. This proof~     of concept is absolutely essential groundwork for any remediation strategy involving selenium~     supplements.~   "
90879|NCT02377622|"~     The study investigates the performance of a new dialyzer (Theranova 400) containing a~     membrane with increased pore sizes. The performance will be determined by the removal of~     middle molecules (with different molecular size) from the blood compartment. Two different~     Theranova 400 prototypes (AA and BB) operated in hemodialysis mode will be compared with a~     Cordiax Fx-80 dialyzer, operated in hemodialysis mode, and with a Cordiax Fx-800, operated in~     high volume hemodiafiltration mode. Safety events and albumin loss into the dialysate will be~     monitored~   "
90880|NCT02377609|"~     The principal aim of this study is to define the relationship between tacrolimus~     concentrations determined from the finger prick DBS (Dry Blood Spot) method and those~     determined from blood samples collected by venepuncture in transplant recipients.~   "
90905|NCT02377284|"~     This pilot study will test the use of visual cues to engage food service workers in~     protecting patrons with food allergies. Food service workers from Philadelphia quick-service~     restaurants were recruited to participate in a survey of attitudes that includes an embedded~     randomized experiment testing an experimental cue (photograph of an allergic child) to~     increase workers' engagement and empathy.~   "
90967|NCT02376478|"~     In this prospective, open, controlled, cross-sectional observational study patients with~     psoriasis or IBD, who received either anti-TNF-alpha inhibitors or alternates (purine-, folic~     acid analogues, phototherapy, fumaric ester, mesalazine) for their underlying disease were~     included.~      Anogenital HPV-induced lesions, mucosal HPV DNA and serological status of mucosal low-risk~     (HPV6) and high-risk HPV (HPV16, HPV18) were determined.~   "
90881|NCT02377596|"~     Our long term objective is to enhance the pediatrician's management of children with feeding~     difficulties in a primary care office-based pediatric practice setting. A prerequisite is to~     rapidly reach an accurate diagnosis so that appropriate therapy can be applied. To improve~     the efficiency and accuracy of the diagnostic interview the investigators have designed a~     Feeding Difficulty Diagnostic Tool (FDDT) consisting of a set of questions that fit beneath a~     'diagnostic cover' and prompts for basic information. Depending on the answers rendered on~     the questionnaire particular diagnoses noted on the cover are flagged for consideration.~      In this study our specific objectives are 1) to assess the feasibility and acceptability of~     using the FDDT in the pediatrician's office and 2) to obtain preliminary data on the~     reliability of using the instrument in the diagnosis and management of children with feeding~     difficulties.~        -  Feasibility and acceptability are often interrelated and will be assessed in a broad~          sense by questionnaires that ascertain, for example, the amount of time needed by~          parents and staff to fill in and use the FDDT questionnaire, the ease and difficulties~          encountered in filling out the FDDT questionnaire and the understanding of the~          questionnaire by the parents.~        -  Reliability relates to the usefulness of the FDDT questionnaire for the pediatrician in~          obtaining and organizing the information obtained from the history and physical~          including anthropometric data to reach a correct diagnosis, the latter being judged in~          this study against the diagnosis reached independently by trained experts in pediatric~          feeding difficulties using a modification of their standard diagnostic interview. The~          frequency of presentation of the various diagnostic sub-categories and the extent of the~          discrepancy between the conclusions suggested by the FDDT, the pediatrician, and the~          feeding disorder experts is unknown. Therefore' this pilot study is needed to help~          determine the sample size necessary to power a more definitive study of the diagnostic~          tool's accuracy, if necessary. The investigators anticipate that at least three of the~          categories (children with excessive selectivity, children with demonstrably poor~          appetite who are vigorous and free of organic disease, and those misperceived to have~          feeding limitations) will be well represented in this preliminary study.~   "
90882|NCT02377583|"~     The general objective is to precise the role of HPA axis activity in neuropsychological~     consequences of type 1 diabetes. The investigators hypothesize that hyperactivity of HPA axis~     is associated with higher scores of depression and changes in hippocampal volume and mean~     diffusion.~   "
90883|NCT02377570|"~     The study investigates the performance of a new dialyzer (Theranova 400) containing a~     membrane with increased pore sizes. The performance will be determined by the removal of~     middle molecules (with different molecular size) from the blood compartment. Three different~     Theranova 400 prototypes (AA, BB and CC) operated in hemodialysis mode will be compared with~     a Cordiax FX-80 dialyzer, operated in hemodialysis mode. Safety events and albumin loss into~     the dialysate will be monitored~   "
90884|NCT02377557|"~     To assess incidence of adverse drug reactions and use pattern of topical steroids among~     patients who are prescribed or purchase over the counter (OTC) topical steroids for skin~     conditions in Korea~   "
90885|NCT02377544|"~     Hopefully this research can help to provide the optimal nutrition management from pregnancy~     so that the babies wiil born with better quality of health and reduce the morbidity and~     mortality.~      Until now, there is no data regarding probiotics in Indonesien breastmilk and the role of~     probiotics supplementation on pregnant women to the baby especially from inflammation~     pathways. The investigators hope the result of this research can help reducing infant~     morbidity and mortality rate in Indonesia, also has a benefit for future research.~   "
90886|NCT02377531|"~     In the current study we aim to determine if early glucose screening and treatment among women~     at high risk for GDM improves perinatal outcome and decreases gestational weight gain. Half~     of the participant will be assigned to an early glucose screen group (12-18 weeks) and~     treatment if necessary and the other half to a standard 24-28 weeks glucose screen.~   "
90887|NCT02377518|"~     Demonstrate the feasibility of dual energy computed tomography using Krypton as a gaseous~     contrast media in order to study the in vivo ventilation.~      Two different clinical situations will be tested :~        -  Prediction of postoperative pulmonary function for oncologic patients~        -  Detection of Bronchiolitis Obliterans in lung transplant recipients.~   "
90888|NCT02377505|"~     This study aims at assessing efficacy and safety of Deep Brain Stimulation (DBS) for~     treatment of patients with treatment resistant schizophrenia, by means of a random,~     controlled and crossed study.~   "
90889|NCT02377492|"~     The goal of the investigators study is to evaluate the effectiveness of paracervical~     injection of vasopressin at the time of abdominal myomectomy to decrease blood loss. The~     investigators will continue to use intramyometrial vasopressin as this has previously been~     shown to be effective. The study will not exceed the safely documented dose of vasopressin.~   "
90890|NCT02377479|"~     The goal of the study is to measure serial hormonal levels in patients undergoing clomiphene,~     letrozole, and a combination clomiphene and letrozole cycle. This information may help us to~     optimize less expensive medications for ovulation induction, reduce the number of treatment~     cycles to achieve a successful pregnancy, and use a medication regimen that may result in~     fewer multiple gestation pregnancies.~   "
90891|NCT02377466|"~     The study's primary objective is to demonstrate the superiority of retosiban to prolong~     pregnancy and improve neonatal outcomes compared with placebo. It is a Phase III, randomized,~     double-blind, parallel-group, multicenter study and will be conducted in approximately 900~     females, aged 12 to 45 years, with an uncomplicated, singleton pregnancy and intact membranes~     in preterm labor between 24^0/7 and 33^6/7 weeks of gestation. Eligible maternal subjects~     will be randomly assigned in a 1:1 ratio to receive either retosiban IV infusion or placebo~     IV infusion over 48 hours. If not previously administered, antenatal corticosteroid treatment~     should be administered as either (1) two 12-mg doses of betamethasone given intramuscularly~     24 hours apart or (2) four 6-mg doses of betamethasone administered intramuscularly every 12~     hours. A single rescue course of antenatal corticosteroids is permitted if the antecedent~     treatment was at least 7 days prior to study enrolment. Investigators have discretion to use~     a standardized regimen of magnesium sulphate, as well as intrapartum antibiotic prophylaxis~     for perinatal group B streptococcal infection. Prior to randomization, each subject will be~     stratified by progesterone treatment and gestational age. The progesterone strata will~     consist of subjects on established progesterone therapy or subjects not on established~     progesterone therapy at Screening. The study will comprise 6 phases: Screening, Inpatient~     Randomized Treatment, Post Infusion Assessment, Delivery, Maternal Post-Delivery Assessment,~     and Neonatal Medical Review. The duration of any subject's (maternal or neonatal)~     participation in the study will be variable and dependent on gestational ages (GA) at study~     entry and the date of delivery.~   "
90892|NCT02377453|"~     A longitudinal study of function and participation in patients with stroke: An integrated~     brain imaging and biomechanical analysis~   "
90893|NCT02377440|"~     The investigators hypothesize that older persons (≥45 years) treated with ACEI for HTN~     control will have: i) improved status of bone turnover (decreased P1NP and CTX), and ii)~     decreased levels of RANKL and RANKL/OPG, compared to those not treated with ACEI and not~     using RAS-related medications~   "
90894|NCT02377427|"~     Mepolizumab is a humanized immunoglobulin G (IgG1) monoclonal antibody (mAb) that exhibits~     dose proportional and time-independent pharmacokinetics. The study will be conducted in 2~     parts. Part A: it will be pharmacokinetic (PK) and pharmacodynamic (PD) study conducted to~     support the use of mepolizumab in children aged 6 to 11 years with severe eosinophilic asthma~     and characterize the PK/PD of mepolizumab 40 milligrams (mg) or 100 mg administered~     subcutaneously depending on participant body weight. Part B: It is a long-term safety /~     pharmacodynamic phase in which extended treatment for a further 52 weeks will be offered on~     an optional basis to those subjects eligible for continued treatment. Participants with~     bodyweight <40 kilogram (kg) will be dosed with mepolizumab 40 mg and participants with body~     weight >=40 kg will be dosed with mepolizumab 100 mg subcutaneously in upper arm or thigh at~     Visit 2 (Week 0). Approximately 40 male or female participants aged 6 to 11 years will be~     screened to achieve approximately 28 eligible participants entering the treatment phase to~     allow availability of 20 evaluable participants, with a minimum of six participants enrolled~     in the <40 kg bodyweight group. The total duration of the study will be 22 weeks and will~     include a run-in period of 1-2 weeks, a treatment period of 12 weeks and a follow-up phase of~     8 weeks. A participant will be considered having completed the study if the participant~     completes all phases of the study including the follow-up phase (Week 20 [visit 8]).~   "
90895|NCT02377414|"~     This study in healthy, adult Japanese women will characterize the PK, safety and tolerability~     of retosiban at the therapeutic doses planned to be evaluated in Phase 3. The PK data will be~     compared to a sub-set of Caucasian women given the same dose of retosiban. This study has two~     cohorts, cohort 1 will be a double-blind sponsor-open (subjects and investigator blinded and~     sponsor unblinded), randomized, continuous 48 hours (h) infusion study in healthy, adult~     Japanese women of child-bearing potential. Cohort 2 is an open label and continuous retosiban~     48 h infusion study in Caucasian, adult, healthy women of child bearing potential. So, the PK~     can be compared with those of Japanese women. Approximately 32 subjects will be enrolled. In~     cohort 1, approximately 24 subjects will be enrolled and randomized to retosiban and placebo~     (2:1 ratio) to have 18 women with 12 active, 6 placebo completed subjects. In Cohort 2, 8~     subjects will be enrolled to have 6 competed subjects. The total duration of a subject's~     involvement in this part is anticipated to be up to 6 weeks (including the 28 day screening~     period).~   "
90896|NCT02377401|"~     Zanamivir is a potent and highly selective inhibitor of the influenza virus neuraminidase.~     Intravenous (IV) zanamivir is being developed for treatment of hospitalized patients with~     influenza, especially for those patients who may be in greatest need of parenteral influenza~     antiviral agents. This study is a pharmacokinetic (PK) study to evaluate the~     safety/tolerability and pharmacokinetic profiles of IV zanamivir 300 milligrams (mg) and 600~     mg in Chinese healthy subjects. Subjects will be randomized to receive either 300 mg or 600~     mg IV zanamivir as a single dose followed by repeated dose every 12 hours (h) for 5 days.~     Subjects will be contacted or will return to study center for a follow-up visit, 7 days after~     the last dose or withdrawal from the study. Total number of subjects planned for enrollment~     will be 24 such that approximately 10 subjects complete dosing and critical assessments in~     each dose cohort. The total duration of the study will be approximately 6 weeks from~     screening to follow-up.~   "
90897|NCT02377388|"~     Cardiovascular events are the main cause of mortality in diabetic patients ,on the other~     hand,during an acute myocardial infarction(AMI),hyperglycemia increases mortality and is~     related to different pathophysiologic processes.~      More important evidence regarding the effect of glycemic control on AMI patients prognosis is~     contradictory,and the potential benefits of dipeptidyl peptidase-4 inhibitors(DPP4-i) in this~     setting is unknown.~      The aim of this study is to assess the presence of pleiotropic effects of DPP4-i(sitagliptin~     or saxagliptin) and their relationship with glycemic control during in-hospital phase of AMI.~   "
90898|NCT02377375|"~     When comparing targeting precision between DBS in parkinsonian patients and OCD patients, an~     unexpected deviation from the planned targets was discovered in OCD patients (Nuttin et al.,~     2013). The objective of this trial is to investigate whether the use of a micro-electrode~     assisted technique improves targeting precision in DBS at the BNST.~   "
90899|NCT02377362|"~     This 3-part study will explore the safety and tolerability of GLWL-01 in overweight/obese~     healthy participants after single doses (in Part A), and in participants with type 2 diabetes~     mellitus after multiple doses during a 28-day period (Parts B and C).~   "
90900|NCT02377349|"~     The purpose of this study is to assess the immunogenicity and safety of Boostrix™ when~     compared to a placebo given during 27-36 weeks of gestation in healthy women aged 18-45~     years. Infants born to mothers enrolled in this study will be followed-up in two separate~     clinical studies: 201330 [DTPA (BOOSTRIX)-048 PRI] and 201334 [DTPA (BOOSTRIX)-049 BST: 048].~   "
90901|NCT02377336|"~     This study will evaluate the effect of GS-6615 in adults with chronic stable angina and~     coronary artery disease (CAD) receiving a stable daily dose of up to 2 antianginal~     medications. The study will consist of two periods: a 1 to 3 week Qualifying Period and a~     Treatment Period lasting 13 days (± 3 days). During the Qualifying Period and at the end of~     the Treatment Period, participants will undergo exercise tolerance testing.~   "
90902|NCT02377323|"~     The purpose of this study is to determine whether Rebif has an impact on employment status,~     quality of life and cognition.~   "
90903|NCT02377310|"~     Instantaneous wave-free ratio (iFR™) is a novel non-hyperaemic index of the functional~     significance of a coronary stenosis. Previous studies have shown variable levels of~     correlation with the established hyperaemic index FFR. In addition it has been proposed that~     iFR™ has superior diagnostic accuracy when compared to mean whole cardiac cycle Pd/Pa which~     can also be used to predict FFR.~      We plan to undertake a prospective clinical study in consecutive patients already undergoing~     FFR assessment in the cardiac catheterisation laboratory to compare the ability of iFR™ and~     Pd/Pa (both measured using the proprietary Volcano system) to predict FFR. We will explore~     the level of misclassification of flow limiting disease that results from use of iFR™ and~     resting Pd/Pa employed using either binary cut-off algorithms or in a hybrid decision making~     protocol. We plan to analyse 260 vessels over a 18 month period. Hyperaemia will be induced~     by intravenous adenosine (140 ug/kg/min) administered wherever possible via an antecubital~     vein. Intra-coronary nitrates will also be given in line with the standard care procedure for~     FFR measurement. Final clinical decisions following coronary physiology will be based on~     steady state FFR.~   "
90906|NCT02377271|"~     Acute ischemic optic neuropathy are the second leading cause of optic neuropathy after~     glaucoma in the population aged over 50 years. The visual prognosis of the condition is~     unfavorable in the great majority of cases, with significant effects on the visual field and~     vision. The severity of the unilateral condition is also associated with bilateralization in~     15% at 5 years. There is no effective treatment for the acute phase of the disease or to~     reduce the rate of bilateralization. In this context, it is essential to develop new~     therapeutic strategies in the acute phase of the disease to reduce the anatomical optic nerve~     damage.~   "
90907|NCT02377258|"~     The primary objective of I-CARE is to assess prospectively the presence and the extent of~     safety concerns (cancers, especially, lymphoma, and serious infections risks) for anti-TNF~     alone or in combination with thiopurines among IBD patients.~      We will stratify the risk of cancers and serious infections according to IBD phenotype and~     disease activity (clinical, radiologic and endoscopic).~   "
90908|NCT02377245|"~     The investigators created a cohort of patients with juvenile inflammatory rheumatisms with~     the purpose to follow them prospectively, and investigate the tolerance and efficacy of~     immunosuppresive and biological agents.~   "
90909|NCT02377232|"~     Several screening methods exist to screen patients for CRC ranging from invasive (i.e.,~     colonoscopy) to less invasive (i.e., testing the stool for blood). Although choice between~     screening methods is recommended, patients are not currently offered an unbiased choice and~     physicians generally recommend only colonoscopy. In this project, the investigators will~     answer the following questions: 1) Is it feasible to incorporate a DA in the AHP protocol?;~     2) Is it feasible to incorporate mailing patients a stool blood test?; 3) Does the DA change~     CRC screening decision quality, using proxy measures such as knowledge and intent; and 4)~     Does the DA change the proportion of participants that complete a CRC screening test? To~     answer these questions the investigators will compare survey responses and CRC test type~     completed between two AHP CRC surveillance patients groups - those that received usual care~     versus those that received the DA.~   "
90910|NCT02377219|"~     Our goal is to prospect the relationships between Bisphenol A (BPA) exposure (measured as its~     free and conjugated forms in blood and urine) and embryo implantation rate (measured as the~     ratio between the number of gestational sacs and the number of transferred embryos) after~     assisted reproductive technology. In order to reduce the confusion factors, the population~     study is limited to young women (aged 28 to 34), with regular menstrual cycles and without~     any medical event that could affect the implantation process~   "
90911|NCT02377206|"~     The purpose of this study is to assess the level of neuroinflammation in Alzheimer Disease~     subject (mild to moderate) estimated with Binding Potential (BP) of [18F]DPA-714, and its~     relationship with the kinetics of cognitive decline over a 24-month follow-up period (as~     assessed by Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) and~     Mini-Mental State Examination (MMSE) scores).~   "
90912|NCT02377193|"~     Induction therapy by either T-cell depleting polyclonal antibodies such as anti-thymocyte~     globulins (ATG) or non-depleting anti-interleukine 2 receptor monoclonal antibodies~     (anti-CD25 moAb: basiliximab or daclizumab) are used to prevent acute rejection, especially~     in highly sensitized patients. Both induction therapy regimens have a different tolerance~     profile. Infections and haematological side-effects are more frequently reported in patients~     receiving ATG.~      The aim of the pilot study is to evaluate ATG and basiliximab induction therapy in de novo~     sensitized kidney-transplant patients (incompatible grafts rate ≥ 50%) without donor specific~     antibodies (DSAs) detected by Luminex.~   "
90913|NCT02377180|"~     There is currently no specific diagnostic test for primary muscular pain. The present study~     investigates whether selective blockade of the suprascapular nerve can effectively abolish~     experimental pain arising from the supraspinatus muscle. Experimental muscle pain is induced~     by intramuscular injection of capsaicin, an alkaloid from red chili peppers. The study~     consists of three parts:~        1. to describe the development, time course and intensity of capsaicin-induced muscle pain~        2. to evaluate the effectiveness of suprascapular nerve block against capsaicin-induced~          muscle pain~        3. to compare suprascapular nerve block and direct intramuscular local anesthetic~          infiltration for their effectiveness in capsaicin-induced muscle pain~   "
90914|NCT02377167|"~     Patients with severe ischemic and hemorrhagic strokes, who require mechanical ventilation,~     have a particularly bad prognosis. If they require long-term ventilation, their orotracheal~     tube needs to be, like in any other intensive care patient, replaced by a shorter tracheal~     tube below the larynx. This so called tracheostomy might be associated with advantages such~     as less demand of narcotics and pain killers, less lesions in mouth and larynx, better mouth~     hygiene, safer airway, more patient comfort and earlier mobilisation. The best timepoint for~     tracheostomy in stroke, however, is not known. Preliminary data from a pilot study of early~     tracheostomy in patients with hemorrhagic or ischemic stroke suggest that such patients may~     also have improved survival and long-term functional outcomes, but a large, multicenter~     clinical trial is needed to confirm these findings.~   "
90915|NCT02377154|"~     The purpose of this study is to determine if the keratometric functions of the VERION Image~     Guided System are comparable to those of established keratometric devices (IOLMaster 500,~     Pentacam HR, LenStar LS900). Calculated intraocular lenses (IOLs) are compared as a clinical~     consequence of the biometric measurement for IOLMaster 500, LenStar LS900 and VERION Image~     Guided System.~      In addition the comfort and duration of examination in the different devices is evaluated.~   "
90935|NCT02376894|"~     The aim of this study is to examine the prevalence, severity, impacts and managements of CRF~     among Taiwanese cancer patients.~   "
90950|NCT02376699|"~     This study will examine the safety profile of SEA-CD40 given alone and in combination with~     pembrolizumab. The study will test increasing doses of SEA-CD40 given at least every 3 weeks~     to small groups of patients. The goal is to find the highest dose of SEA-CD40 that can be~     given to patients that does not cause unacceptable side effects. Different dose regimens will~     be evaluated. Different methods of administration may be evaluated. The pharmacokinetics,~     pharmacodynamic effects, biomarkers of response, and antitumor activity of SEA-CD40 will also~     be evaluated.~   "
90951|NCT02376686|"~     The purpose of this study is to determine whether music hearing in the evening before going~     to sleep can improve sleep quality, depressive symptoms and quality of life in patients with~     affective disorders.~   "
90916|NCT02377141|"~     Gastro-oesophageal varices (swollen veins in the gullet and stomach) are present in 50% of~     patients with liver cirrhosis and are its most serious complication as their rupture results~     in potentially life threatening bleeding. Bleeding from these veins occurs in up to one third~     of patients with varices. This is associated with 20% mortality at 6 weeks.~      In the event of bleeding from these veins the current UK guidelines recommend certain drugs~     followed by early endoscopic treatment with variceal band ligation (rubber bands placed over~     the veins to stop them bleeding). The use of a shunt inside the liver (TIPSS transjugular~     intrahepatic portosystemic shunt) is largely reserved for cases of uncontrolled bleeding from~     these swollen veins. A recent randomised multicenter study carried out by Garcia Pagan and~     colleagues reported improved survival with early TIPSS in patients with bleeding from these~     swollen veins in advanced liver disease. From these guideline international guidelines now~     recommend consideration of early TIPSS for all high-risk patients presenting with variceal~     bleeding. This practice clearly has significant cost implications. To validate the findings a~     further randomised control trial is needed.~      This is a multi-center parallel-group randomized controlled trial. Both hospitals taking part~     in the trial will have a TIPSS service. Patients who consent to enter the trial will be~     randomized to either: (1) Endoscopic treatment (standard care) or (2) early TIPSS.~      Potential participants will be all patients with a diagnosis of liver cirrhosis presenting~     with an acute variceal bleed to a participating hospital who do not fulfill an exclusion~     criteria. All causes of cirrhosis will be included.~      Participants will be reviewed during their regular hepatology clinic appointments at their~     respective hospitals on 3 occasions over a one-year period.~   "
90917|NCT02377128|"~     The aforementioned study was designed to evaluate short term ovarian reserve as assessed by~     anti-Mullerian hormone(AMH) levels following bilateral salpingectomy versus tubal ligation,~     as part of cesarean sections performed in women requesting future sterilization. The~     investigators aim to recruit 3 groups of 15 women undergoing elective cesarean section at the~     investigators' institution, 2 of which request sterilization (allocated to tubal ligation or~     bilateral salpingectomy) and one undergoing solely cesarean section. The groups will have~     blood drawn for AMH prior to the procedure and at a post-operation visit 8 weeks following.~     This is preformed in light of validated data offering better sterilization and possible~     diminished future risk of ovarian cancer with salpingectomy. Also, is has been proved to be~     just as safe as tubal ligation. This will be performed as a randomized controlled trial.~   "
90918|NCT02377115|"~     Postoperative delirium (POD) - a temporary state of confusion - is a frequent complication of~     surgery, which most commonly occurs in elderly patients. A tablet computer application that~     may assist preoperative risk screening for POD was developed at the University Hospital Basel~     in 2014. This study aims to investigate whether the computer program may assess the risk of a~     patient to develop POD.~   "
90919|NCT02377102|"~     Purpose: For the target population of adult patients with end stage osteoarthritis, this~     randomized clinical trial will be used to evaluate the benefit of three months of physical~     therapy compared to no treatment in patients indicated for total knee arthroplasty.~      Participants:Patients that are diagnosed with end stage osteoarthritis who are indicated for~     total knee arthroplasty.~      Procedures: Patients will be randomized to either receive physical therapy or no treatment.~     They will be scheduled to return in 3 months for discussion of operative versus continued~     nonoperative treatment of their osteoarthritis.This will be determined by change in PROMIS~     (Patient Reported Outcome Measurement Information System) score and prevention of surgery.~   "
90920|NCT02377089|"~     The investigators propose to use a clinical trial to test Trigeminal Nerve Stimulation (TNS)~     to examine the efficacy of TNS as a new treatment for PTSD in veterans. Recruitment will take~     place at the PTSD Outpatient Clinic at the VA GLA. Study participants will be asked to~     complete, at most, 9 assessments/questionnaires regarding their PTSD symptoms and quality of~     life, use the TNS device every night for 8 hours, log their use of the device, and attend~     weekly visits to monitor safety and complete assessments. Each subject will be asked to~     attend 8 visits over the course of 8 weeks. Subjects who receives the sham-controlled~     treatment will have an additional follow-up phone visit 4 weeks after the week 8 endpoint to~     examine symptom improvements.~      Enrollment and subject-related procedures are projected to take approximately 36 months.~     Preparations for clinical trial, clinical trial/study procedures and data analysis will~     occupy a 6 month period, a 36 month period, and a 6 month period, respectively. The duration~     of this project is approximately 4 years.~   "
90921|NCT02377076|"~     Dietary calcium seems to act on glycemic control, favoring the prevention and treatment of~     type 2 diabetes mellitus (DM2). It is possible that calcium modulates gut microbiota and~     increase the integrity of the intestinal mucosa. This study aims to evaluate the effects of~     dietary calcium supplementation in permeability and intestinal microbiota in overweight type~     2 diabetics. This is a single-blind, randomized, placebo-controlled, crossover study.~     Patients (n=20) with low habitual calcium intake will be allocated in control group (CONTROL)~     or test group (DAIRY). Hypocaloric diets (restriction of 500 kcal / day) will be prescribed~     containing 800 mg of calcium from dietary sources / day. During intervention period, a~     beverage (shake) (CONTROL - without the addition of calcium sources or DAIRY - 700 mg of~     calcium as milk powder) will be ingested in the laboratory. Food intake, body composition~     (total body fat and fat free mass) and anthropometric measures (waist circumference,~     waist-hip ratio, waist-height, neck circumference and sagittal abdominal diameter) will be~     evaluated at baseline and at the 6th and 12th weeks. Physical activity level, gut~     permeability, gut microbiota, and biochemical parameters (parathyroid hormone, 25-dihydroxy~     vitamin D, calcium, fasting glucose, fasting insulin, fructosamine, hemoglobin, HbA1c, uric~     acid, triglycerides, cholesterol total and partial, lipopolysaccharide, inflammatory markers)~     will be evaluated at baseline and after 12 weeks. The statistical analysis will be performed~     with the use of SPSS software (SPSS Inc., Chicago, IL, 2008, version 17.0). Parametric or~     non-parametric tests will be applied, according to the distribution of variables (level of~     statistical significance of 5%).~   "
90922|NCT02377063|"~     This is a 4 ½ week study with 20 healthy subjects (including a 2 week run-in ) . Subjects~     will be taking vegetable/fruit juice supplementation for 3 days. Blood, urine and stool~     samples will be collected at baseline, day 4 and day 17. The purpose of the study is to~     determine the effects of fruit/vegetable supplementation on colonic flora.~   "
90923|NCT02377050|"~     The primary hypothesis is that preterm infants who are less than or equal to 32 weeks~     gestation and weigh 1001-2500 grams at birth will have an increase in weight gain with a~     feeding goal of 180-200 ml/kg/day more than the commonly used feeding goal of 140-160~     ml/kg/day~   "
90946|NCT02376751|"~     This is an open-label, multicenter expanded access protocol to allow patients with a~     confirmed diagnosis of Lysosomal Acid Lipase (LAL) Deficiency in the United States (US),~     access to sebelipase alfa (recombinant lysosomal acid lipase [rhLAL]) until commercial~     product is available.~      Patients enrolled in the expanded access protocol will receive 1 mg/kg intravenous infusions~     of sebelipase alfa every other week.~   "
90924|NCT02377037|"~     There is already a lot of scientific evidence supporting the benefits of public health~     recommendations regarding physical activity (the accumulation of at least 150 minutes of at~     least moderate intensity physical activity per week). However, these 30 daily minutes~     represent only about 3% of the waking period. Recent data suggest that most of the population~     spends on average 8-9 hours / day of sedentary behavior (SB). SB is characterized by any~     activity with a metabolic cost (MC) below 1.5 METs, mainly actions in the sitting position.~     In fact, there is evidence that the more time spent sitting higher the risk of disease and~     mortality, with sitting directly associated with diseases such as type II diabetes,~     cardiovascular diseases and even cancer. The average life expectancy may increase by ~ 2~     years if the investigators reduce sitting about 3h/ day. Additionally, how people accumulate~     sitting time seems to be a major factor, with prolonged sitting associated with a higher risk~     of disease. Short-term experimental studies indicate that sedentary lifestyles affect energy~     balance enhancing weight gain. While there is some research regarding the MC associated with~     sitting and standing behaviors, the results are contradictory. Besides these conflicting~     results, the impact of transitions between these two types of behavior and how these~     transitions can contribute to MC increase have never been investigated.~      Our hypothesis is that, in both men and women, the simple replacement of sitting for~     standing may not substantially increase MC, but instead, the largest contribution may~     reside on the transitions between these two states of behavior. Therefore, the investigators~     will perform a study with the following purposes:~      Examine MC and HR associated with sitting, standing, and transitions between these two~     types of behavior in adults of both gender, apparently healthy with variable body composition~     profiles.~   "
90925|NCT02377024|"~     The objective of this study is to demonstrate the cognitive enhancement effect and safety of~     Tremella Fuciformis, using the cognitive and clinical indicators (e.g. memory, attention, and~     psychomotor speed) and the latest brain imaging methods for healthy adults suffering~     subjective cognitive impairment.~   "
90926|NCT02377011|"~     A randomized controlled trial to test the whether remote delivery of cognitive based therapy~     (CBT) is clinically and cost effective when compared to treatment as usual in adolescents and~     young adults with depression who self-harm.~   "
90927|NCT02376998|"~     Most blunt aortic injuries occur in the proximal proximal descending aorta causing acute~     transection of this vessel. Generally, surgical repair of the ruptured segment of aorta is~     associated with high rates of morbidity and mortality and in this view endovascular treatment~     seems to be a valid and safer alternative. Aim of this study is to review the experience of a~     single center with endovascular approach for the treatment of acute traumatic rupture of~     descending thoracic aorta~   "
90928|NCT02376985|"~     To examine whether the occurrence of oral mucositis can be reduced by dental oral management~     in patients by comparing the use of dental oral management through instruction by dental and~     oral surgeons (dental oral management group) and an observation group (brushing instruction~     only group) in a randomized, controlled study in females that are using everolimus for~     estrogen receptor-positive, hormone therapy-resistant refractory breast cancer.~   "
90929|NCT02376972|"~     THE STUDY HAS BEEN DESIGNED TO COMPARE THE EFFICACY OF TWO DOSES (25 MG AND 100 MG) OF~     RIFAXIMIN VAGINAL TABLETS VERSUS PLACEBO IN SUBJECTS WITH BACTERIAL VAGINOSIS~   "
90930|NCT02376959|"~     Background: The use of alternative therapies in medicine has been increasing worldwide. Among~     these therapies are energy therapies such as Reiki , Johrei, and Spiritist passe.~     Experimental studies have confirmed the action of the energy therapies in animal models or in~     cell cultures. These therapies appear to have positive effects, particularly in the reduction~     of anxiety and pain. Objective: To evaluate the effectiveness of the passe energy therapy~     in reducing anxiety in subjects presenting anxiety symptoms after 8 weeks of study. Methods:~     The recruited volunteers will be randomized into two groups: the Control Group (application~     of 8 passe simulation sessions by people without spiritualist training at the same time and~     in the same environment as the treatment group) and the Treatment Group (application of 8~     sessions of passe by spiritists with over 2 years of experience in controlled environments~     for the same period as the control group). The sample will consist of 60 patients selected by~     interviews with the expectation of a 20% reduction of anxiety in the control group and 60% in~     the treatment group with alpha of 0.05 and beta of 0.8. Results: Using the STAI scale for~     evaluation, the reduction in anxiety is expected to be significantly higher in the treatment~     group than in the control group. The investigators expect approximately 20-30% reduction of~     the anxiety in the control group by the placebo effect. Other objectives to be assessed are~     quality of life, spirituality, and depression by specific standardized scales (WHOQOL-BREF,~     DUREL, and BECK).~   "
90931|NCT02376946|"~     This study is a prospective, randomized, double-blinded, controlled, clinical trial that~     evaluates the efficacy of using PEMF in the postoperative period in decreasing swelling and~     pain after extraction of impacted third molars. The study group will be comprised of subjects~     that will receive PEMF Actiband treatment for postoperative management of pain and edema. The~     control group will be comprised of the subjects that will receive a placebo patch as~     treatment for postoperative management of pain and edema.~      Thirty (30) subjects will be randomly assigned to each group. Enrollment will continue until~     60 qualified subjects have been recruited. Eligibility criteria will be based on the~     standards for conducting oral surgery procedures on third molar extractions, in addition to~     safety considerations and contraindications for the Actiband and other agents to be used.~     Moreover, the selected subjects will have the same surgical difficulty and surgical trauma~     anticipated standardized by classification system of impacted third molars. All inclusion and~     exclusion criteria will be thoroughly explained in the relevant section of this proposal.~     Postoperative edema and pain will be evaluated using 3dMD and Visual Analog Scale,~     respectively. Different measurements will be obtained immediately before the surgery and in~     standard periodic intervals as described in the Materials and Methods section of the~     proposal. Any difference in postoperative edema, pain, and site responsible for request of~     rescue pain medication will be compared and analyzed between the two groups.~   "
90932|NCT02376933|"~     Vertebral augmentation with radiotherapy to increase the functional status and quality of~     life for patients with vertebral body metastatic cancers.~   "
90933|NCT02376920|"~     Uveal Melanoma is a rare cancer with approximately 3,000 cases diagnosed in the US every~     year. Nearly half of these experience spread of their cancer outside the eye. The~     DecisionDx-UM gene expression test classifies an individual's tumor as low risk (class 1) or~     high risk (class 2) of spreading. This study is being done to collect information about how~     physicians are using the DecisionDx-UM results to design individual treatment plans. It will~     also track outcomes or the uveal melanoma population that received DecisionDx-UM testing.~   "
90934|NCT02376907|"~     This is a retrospective study to evaluate the outcomes of endoscopic biliary drainage~     according to the timing of distal malignant biliary obstruction (MBO) in relation to gastric~     outlet obstruction (GOO) and the location of GOO.~   "
90936|NCT02376881|"~     Methanol poisoning could result in severe optic neuropathy, profound visual loss and finally~     optic atrophy and permanent, irreversible optic atrophy and visual loss. Erythropoietin (EPO)~     has recently emerged as a drug that may help retinal ganglion cell loss and improve optic~     nerve function in some acquired types of optic neuropathy including traumatic optic~     neuropathy ,ischemic optic neuropathy and optic neuritis .It has been found that EPO offer~     some protection to the optic nerve and retina when they are injured and apoptosis process~     starts in retinal ganglion cells. The standard treatments of methanol poisoning are~     reanimation, metabolic stabilization, and inhibition of alcohol dehydrogenase by antagonist~     agents and elimination of toxic metabolites in early phase of toxicity by dialysis. However,~     after established optic neuropathy and visual loss there is little chance, if any, for visual~     recovery and no definitive treatment exist for treatment in these cases. The investigators~     recently reported the investigators preliminary results on 16 cases with methanol poisoning~     and found a beneficial effect of systemic erythropoietin in methanol associated optic~     neuropathy. Now, the investigators aim to investigate the effect of this agent in a clinical~     trial.~      The purpose of this study is to determine if EPO could improves optic nerve function and help~     patients to improve visual recovery after methanol poisoning. Primary outcome measure would~     be best-corrected visual function and secondary outcome measure is ocular coherence~     tomography (OCT) measure of mean peripapillary nerve fiber layer thickness. Results of this~     study could be very valuable in formulating an evidence-based management of Methanol~     Associated Optic Neuropathy(MAON) and provide a high level evidence for changing the practice~     on management of methanol poisoning . Also it could provide valuable data for neuroprotective~     effects of erythropoietin specifically in neuroscience and ophthalmology.~      The EPO-MAON trial is designed as a randomized, controlled, observer, and interpreter blinded~     mono-center pilot trial with two parallel groups and a primary endpoint of best corrected~     visual acuity during 120 days after enrollment into treatment groups.~      All patients with methanol poisoning referred to Farabi hospital will be examined and~     evaluated for best-corrected visual acuity, pupillary light reflexes, relative afferent~     pupillary defect, color vision (Ishihara plates), fundus photography, slit lamp exam of~     anterior segment and fundus exam with 78 D lens.~   "
90937|NCT02376868|"~     Assess the repeatability and agreement of the Optic Disc Parameters, Retinal Nerve Fiber~     Layer (RNFL) Thickness, Full Retinal Thickness, and Ganglion Cell Thickness between the~     Maestro and iVue OCT devices.~   "
90938|NCT02376855|"~     The purpose of this study is to evaluate the implementation of an electronic consultation~     model for specialty services (eConsults) to improve quality of care and reduce health system~     costs. An eConsult is a non-face-to-face consultation between a primary care provider and a~     specialist that takes place via secure messaging.~   "
90939|NCT02376842|"~     The investigators hypothesize that implementing an electronic health record-based early~     warning system for severe infections (severe sepsis) will decrease the time to antibiotic~     order. The study will consist of an algorithm which will monitor lab values, vital signs, and~     nursing documentation for signs of severe sepsis. When these criteria are met, an alert will~     be delivered via the electronic health record to a nurse and doctor and simultaneously an~     alert via pager to another nurse. The investigators plan to randomize which patients will~     generate these alerts and analyze the data after collecting information for approximately 6~     months which will be sufficient to detect a 10% difference in the two patient groups.~   "
90940|NCT02376829|"~     To demonstrate that growing teenagers which present up to full cusp Class II malocclusions~     can be treated using the Invisalign System.~   "
90941|NCT02376816|"~     The proposed phase I clinical trial is a pilot study to evaluate safety and biological~     activity of the rAAVrh74.MCK.micro-Dystrophin vector administered by an intramuscular route.~     This study will evaluated the micro-Dystrophin vector as a potential dystrophin replacement~     mechanism for Duchenne Muscular Dystrophy. Two cohorts will undergo gene transfer in a~     standard three-six dose escalation scheme to establish maximum tolerated dose (MTD) using~     toxicity. A minimum of three subjects will be enrolled into each cohort. The first cohort~     will receive a total dose of 3E11 vg. The second cohort will receive 1E12 vg total dose.~   "
90942|NCT02376803|"~     Warfarin is an anticoagulant medication that is highly effective at preventing clotting~     disorders but which has a narrow therapeutic window. If warfarin is under effective patients~     are at risk of stroke, if it is over effective patients are at risk of bleeding~     complications. Physicians routinely and regularly measure a blood test (called the INR)~     that determines the effectiveness of warfarin and have a range of test values (the~     therapeutic range) in which they try to keep the patient. By convention warfarin is taken~     at dinnertime, however this is the same time of day that highly variable consumption of~     dietary vitamin K occurs (found largely in green leafy vegetables) and vitamin K alters the~     effectiveness of warfarin. Given vitamin K has a very short half-life (i.e. it is only active~     for a short period of time after it is ingested) it may make more sense to take warfarin in~     the morning (when very little vitamin K is ingested) to produce a more consistent drug~     effect. The purpose of this study is to determine whether switching current warfarin users~     from evening to morning dosing decreases time spent outside the therapeutic INR range.~   "
90943|NCT02376790|"~     The purpose of this study is to learn more about the role of etanercept alone or in~     combination with methotrexate on disease activity in subjects with psoriatic arthritis.~      To do this, etanercept alone will be compared to methotrexate alone or to combination~     etanercept and methotrexate.This study will last approximately 1 year (52 weeks) for an~     individual subject.~      Subjects will be randomized into 1 of 3 groups. Subjects will have a 1 in 3 chance of~     receiving etanercept plus methotrexate, etanercept alone or methotrexate alone. Neither the~     subject nor the study doctor can choose the group to which the subject will be randomized~     into. Subjects will take one study medication by injection under their skin and a second~     medication taken by mouth. After the first 24 weeks of the study, if the doctor evaluates the~     subject and determines that their condition has not improved, the subject may qualify to~     receive etanercept plus methotrexate.~   "
90944|NCT02376777|"~     Differences in efficacy and safety between new oral anticoagulants (NOAC) and vitamin K~     antagonist (VKA) in real practice remain uncertain.~      The few existing ambulatory studies did not answer all NOAC specific issues, such as~     prescription habits and motives, patients characteristics, biological monitoring, as well as~     the occurrence of major and minor thromboembolic events, especially in France where warfarin~     is less frequently prescribed.~      Therefore, in order to describe clinical and follow up characteristics of patients receiving~     oral anticoagulants, the investigators will set up a national prospective cohort to compare~     the occurrence of thromboembolic events between VKA and NOAC in primary care.~   "
90945|NCT02376764|"~     This study aims to deepen the investigators knowledge of Post Thrombotic Syndrome and MMPs~     (and other related molecules such as TIMPS, NGAL and cytokines) to find a predictive~     molecular system to better classify the risk of patients to develop a PTS after a DVT~     episode, in order to monitorate more strictly the patients at high risk for developing this~     complication.~   "
90947|NCT02376738|"~     This study aims to evaluate the role of leukocyte activation in coronary artery disease~   "
90952|NCT02376673|"~     This randomized controlled trial compares a specially-designed children's book to standard~     brochures for safe sleep education and reduction of Sudden Infant Death Syndrome (SIDS) risk~     in a high-risk population of young, first-time mothers enrolled in a home visitation program.~     Roughly half of the mothers will receive safe sleep education via the book, the other half~     via brochures, during prescribed home visits. Our study will assess differences in safe sleep~     knowledge, adherence to recommendations, satisfaction with materials used, and attitudes~     towards reading with their baby. Our hypothesis is that these will be higher in the group~     receiving the book, due to simpler language, appealing illustrations, emotional connection,~     and repeated exposures via shared reading.~   "
90953|NCT02376660|"~     A randomized control trial to assess the effect of oats on lipid profile of mildly~     hypercholesterolemic subjects. Subjects consumed 35g of oats twice daily (total of 70g / day)~     in place of carbohydrates as part of their usual diet. 70 grams of oats provide 3 grams of~     soluble fiber. Control group consumed the usual diet. Subjects followed up for 4 weeks. In~     total 3 assessment visits of the subjects planned for the study period.~   "
90954|NCT02376647|"~     This is a multicenter randomized controlled pilot trial to investigate the feasibility of a~     driving pressure limited mechanical ventilation strategy compared to a conventional strategy~     in patients without acute respiratory distress syndrome (ARDS).~   "
90955|NCT02376634|"~     The purpose of this randomized controlled study is to test the feasibility of clinical~     hypnotherapy as a perioperative intervention for the reduction of pre-operative anxiety,~     post-operative pain, and other-related symptoms (nausea, vomiting, spasms, length of stay,~     self mastery) in children undergoing scoliosis repair or Nuss procedure.~   "
90956|NCT02376621|"~     The study will evaluate the bioavailability of omega-3 based dietary supplements under fasted~     conditions in healthy adult subjects. Each subject will participate in 5 treatment periods.~     The order of treatments will be in accordance with the randomisation schedule.There will be a~     minimum of 4 treatment-free days between each treatment period. On each dosing occasion,~     subjects will be fasted for at least 10 hours overnight, prior to the morning of dosing.~     Twenty-four subjects will be enrolled to complete dosing of 20 subjects.~   "
90957|NCT02376608|"~     The study will evaluate the relative bioavailability of Pronovum PRF-037 and Pronovum PRF-041~     with PronovaPure 150:150 EE EU and Eskimo-3 (500 mg omega-3 acid triglyceride containing 80~     mg EPA and 50 mg DHA per gram oil) in healthy subjects.~   "
90958|NCT02376595|"~     The purpose of this study is characterize the dose-effect relationship of rocuronium bromide~     at the adductor pollicis and masseter muscles using an pharmacokinetic-pharmacodynamic (PKPD)~     model. The hypothesis is that masseter muscle has a greater sensitivity to the neuromuscular~     blockers (rocuronium), faster onset and slower recovery profile than the adductor pollicis~     muscle.~   "
90959|NCT02376582|"~     The primary objective of the proposed phase I trial is to evaluate the safety and~     tolerability of DNA-HIV-PT123 and AIDSVAX®B/E combination regimen. Though both DNA-HIV-PT123~     and AIDSVAX®B/E and the combination of the two vaccines have been evaluated in humans and~     have shown to be safe and well tolerated, this is the first time the combination regimen is~     being evaluated in HIV-1 uninfected African populations with and without S. mansoni. The~     secondary objective of the trial is to evaluate the effect of S. mansoni infection on the~     immunogenicity of the combination of DNA-HIV-PT123 and AIDSVAX® B/E vaccine regimen.~     Successful vaccination against most viruses requires efficient Th1 response. There is~     evidence that helminth infections skew the host immune system of human and animals to~     T-helper type 2 (Th2) and induce immunosuppression. Therefore, there is a potential that~     helminth infected populations may not generate the desired immune responses to vaccines~     designed to drive Th1-type and cytotoxic T-cell responses.~      Furthermore, the influence of helminth infections on the development of protective antibody~     responses remains unclear. Limited data in animal models suggests that worm infections~     reduced efficacy of vaccines.~      The proposed vaccine trial will generate safety, tolerability and immunogenicity data of a~     vaccination regimen with simultaneous administration of a candidate HIV DNA vaccine~     (DNA-HIV-PT123) and a gp120 protein vaccine (AIDSVAX®B/E). This will be the first HIV vaccine~     trial to prospectively evaluate the impact of the S. mansoni infection on safety and immune~     responses to HIV vaccines.~   "
90960|NCT02376569|"~     This study intends to collect self-reported information with multiple surveys about lifestyle~     habits, food and drink, state of mind (happy, sad, etc.) and traits (decision making, general~     personality, etc.) The purpose of this study is to understand relationships between~     self-reported information, game performance, and passive physiology measures throughout a~     daily cycle.~   "
90961|NCT02376556|"~     The investigators aim to assess the effect of blepharoplasty with or without muller muscle~     resection on the symptoms of dry eye syndrome. this will be an observational study in which~     patients undergoing the aforementioned surgeries will be followed up and monitored for dry~     eye symptoms.~   "
90962|NCT02376543|"~     Comparison Study between 19 gauge EUS FNA BNX Needle vs. 22 gauge EUS FNA BNX Needle in~     Pancreatic Fiducial Placement To Treat Pancreatic Cancer~   "
90963|NCT02376530|"~     The purpose of the research is to examine the association between price changes, nutrient~     profiling, and grocery food purchases among household grocery shoppers.~   "
90964|NCT02376517|"~     The purpose of this study is to test the effectiveness of a sun protection education program~     for children of all ethnic and racial backgrounds. Practicing sun protection in childhood can~     reduce the likelihood of developing skin cancer as an adult. The educational program consists~     of a read-along book in English and Spanish for the child to read with the parent or~     caregiver, text message reminders to practice sun protection, and a sun protective swim shirt~     for the child.~   "
90965|NCT02376504|"~     The primary objective of this project is to determine the effects of decreasing sedentary~     behavior at work by at least 3hrs/day using treadmill (walking and standing) and sit-to-stand~     (standing only) workstations on the health of overweight office workers.~   "
90966|NCT02376491|"~     This trial will compare innovating stimulation parameters, intermittent Theta Burst~     Stimulation, to the standard high frequency stimulation protocol. The Left dorsolateral~     prefrontal cortex, targeted by MRI navigation will be the site of stimulation in both~     treatment conditions. The study seeks to determine if there is a superiority in therapeutic~     efficacy with iTBS protocol compared to conventional one.~   "
90972|NCT02376413|"~     Breast-conserving surgery (BCS) is the traditional surgical treatment for early-stage breast~     cancer patients. There are evidences indicating that oncoplastic-BCS (displacement technique)~     could improve cosmetic outcomes and/or quality of life, and has similar oncological safety as~     traditional BCS does. However, there are no prospective trial comparing oncoplastic-BCS vs.~     traditional BCS in terms of cosmetic outcomes and oncological safety. In this study, the~     investigators are going to address this issue by assigning patients into traditional and~     oncoplastic-BCS group, based on their preference.~   "
90973|NCT02376400|"~     The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and~     Ad26.ZEBOV administered as heterologous prime-boost vaccine regimens in healthy adult~     participants.~   "
90974|NCT02376387|"~     The proposed research will provide evidence-based strategies for the evaluation and~     acceptance of donor hearts for transplantation. This is relevant to public health because~     judicious expansion of donor hearts used for transplantation will make this life-saving~     procedure available to a larger number of patients living with end-stage heart disease.~   "
90975|NCT02376374|"~     The investigators propose to study both inter- and intra-household Oral Polio Vaccine (OPV)~     transmission in a primarily inactivated-polio vaccine (IPV)-vaccinated community in Mexico.~     The investigators will enroll 3 distinct clusters of households in a municipality in Orizaba,~     Veracruz, Mexico prior to the February 2015 National Immunization Week (NIW.) These clusters~     will be physically separate from one another and differ only in the proportion of~     OPV-eligible children who will receive OPV during the February 2015 NIW (10%, 30% and 70%~     vaccinated.) The investigators will look at inter-household and intra-household transmission.~     The investigators will then determine if epidemiologic (i.e.: degree of contact),~     anthropometric (i.e.: nutritional status) or clinical covariates (i.e.: IPV/OPV immunization~     history) are associated with intra-household transmission.~   "
90976|NCT02376361|"~     The purpose of the study is to learn if monitoring dialysis access blood flow during dialysis~     treatment with a transonic machine (an ultrasound technique) will prevent (or reduce) the~     development of dialysis access thrombosis (clotting).~      Investigators would like to study if monitoring with a specific technique called ultrasound~     dilution technique can help prevent problems with access when compared to what is the current~     standard of care for patients.~   "
90977|NCT02376348|"~     Tanzania launched a National Strategy for scaling-up voluntary medical male circumcision in~     2010, and aims to circumcise 2.8 million males by 2015. In September 2009, Jhpiego's Maternal~     and Child Health Integrated Program (MCHIP) launched a PEPFAR-funded voluntary medical male~     circumcision (VMMC) program which has circumcised over 110,000 males in Njombe and Iringa~     regions by June 2012. In line with the national strategy, the target age for the program was~     10-34 years, but 80% of clients were aged 10-19 years. There is an urgent need to increase~     the proportion of older men (aged 20 years and above) who become circumcised, to have~     greatest impact on the HIV epidemic.~   "
90978|NCT02376335|"~     Primary Biliary Cirrhosis (PBC) is a liver disease that predominantly affects females, can~     present for the first time at any age and which develops over many years. It is caused by the~     immune system attacking the body's own tissues. People with PBC frequently experience~     profound fatigue or tiredness which they liken to their batteries running down and although~     people still want to undertake normal activities they often lack the energy to be able to do~     them. This reduces quality of life, makes it difficult for people to work and can end up with~     them becoming isolated in the community. At present the investigators have no treatment for~     fatigue in PBC. Finding a treatment for fatigue in PBC is one of the highest research~     priorities identified by patient groups.~      The aim of this study is to undertake a clinical trial to examine the effects of a treatment~     (Rituximab) on severe fatigue in PBC to help us understand whether this will be a~     potentially useful treatment. The information that this will give us about how energy~     generation changes in patients with PBC with and without the treatment will also help us to~     develop new treatments for fatigue in other diseases. The study has the potential to improve~     the quality of life of many patients with PBC, for whom there is currently no hope of~     improvement.~      The investigators will perform a randomised controlled study of Rituximab therapy in PBC~     compared to placebo (1:1 ratio).~      The study will be performed in a specialised clinical research environment at Clinical~     Research Facility Royal Victoria Infirmary. The investigators have, for many years, worked~     closely with PBC patient groups to focus on the problems that are important to our patients.~     This study is fully supported by Liver North, a liver disease charity and patient support~     group.~      The study will take place over one year and will involve between 9 and 20 visits although a~     number of these will be telephone visits. Blood tests and quality of life questionnaires will~     be performed at the start of the study and after three, six, nine and twelve months. At~     baseline and 12 weeks follow up physical activity will be monitored using monitors, and an~     exercise test and MRI scan will be performed.~   "
90979|NCT02376322|"~     Literature has shown that hypofractionated radiotherapy regimens are efficacious in patients~     with complicated bone metastases and have a low potential for severe treatment-related~     toxicities. There is a clear need for hypofractionated schedules in the complicated bone~     metastases population, especially when considering the overarching aim of palliative~     radiotherapy and the clinical features of this patient population. As well, current research~     examining hypofractionated approaches in bone metastases patients with impending or~     pathologic fractures, neuropathic pain or accompanying soft tissue masses has been markedly~     scarce.~   "
90980|NCT02376309|"~     A decrease in muscle mass can have a profound impact on quality of life, as it can lead to~     decreased strength, insulin resistance, lower basal metabolic rate and obesity. With this~     study we investigate whether ingesting leucine or getting a ND injection will reduce the loss~     of muscle mass and strength.~   "
90981|NCT02376296|"~     In this observational study, blood samples for pharmacokinetic (PK) testing will be collected~     from subjects with metastatic prostate cancer during their treatment with docetaxel. Plasma~     levels of docetaxel will be determined, and the subjects docetaxel exposure levels,~     determined as an area under the curve (AUC), will be retrospectively correlated with reports~     of toxicity, tumor response, quality of life, time to disease progression and overall~     survival to provide guidance on what the appropriate target range for docetaxel exposure~     should be for metastatic prostate cancer subjects receiving docetaxel therapy for their~     disease.~   "
90989|NCT02376192|"~     This is a study of pregnant women undergoing a cesarean delivery. It will compare their~     microcirculation before and after the anesthetic. Microcirculation means blood flow to the~     extremely small blood vessels in the body. It will also look at the differences in~     microcirculation of participants who receive an infusion of phenylephrine compared to~     participants who don't. The investigators hypothesize that spinal anesthesia will reduce the~     vascular density and proportion of perfused vessels.~   "
91526|NCT02369172|"~     CYP2B6 is involved in the metabolism of many drugs. So, it is important to assess in vivo the~     effect of ASP2151 on that enzyme to determine any possible drug interactions. The aim of this~     trial is to investigate the potential for interaction of ASP2151 with the CYP2B6 probe~     substrate bupropion.~   "
90982|NCT02376283|"~     Major heart attacks are caused by a numerous factors, including sudden clot formation in a~     coronary artery leading to a blockage and heart muscle death. The clots are largely made of~     sticky clotting blood cells (platelets). A patient having a major heart attack is treated~     with emergency primary percutaneous coronary intervention (PPCI) where a wire and balloon are~     used to reopen the coronary artery and a stent (a slotted metal tube) is placed to keep the~     artery open.~      Aspirin, and one of two other antiplatelet drugs (prasugrel or ticagrelor) are given prior to~     PPCI to prevent further clots formation. Both antiplatelet drugs are taken in tablet form and~     in healthy stable patients these drugs take at least 30 min to 2 hours to exert an adequate~     effect. Often PPCI procedures are performed well within this timescale. It is possible that~     having a major heart attack limits the bodies ability to absorb the drugs also.~      In this study, patients with major or minor heart attacks will be given either prasugrel or~     ticagrelor as per licensed indications and guideline recommendations. A 15 ml blood sample~     will be taken at first balloon inflation to reopen the blocked artery, then after 20 minutes,~     60 minutes, and 4 hours after taking the drugs. Each blood sample will be subjected to a~     variety of tests to determine antiplatelet drug activity.~      This study will identify which of the two agents used are working effectively during PPCI,~     given the very short timescales involved. It will also show if patients with major heart~     attacks absorb the drugs less well than patients with less severe heart attacks. In the~     future it might be that an intravenous agent will be more valuable in the setting of PPCI.~   "
90983|NCT02376270|"~     The population is aging worldwide, which requires more attention to health needs and leads to~     a dramatic increase in health care costs. Prevention or delay of onset of disorders~     associated with aging is needed. Dietary intake of pectin, a dietary fiber, may have~     beneficial effects on gut health parameters, i.e. intestinal barrier function, immune~     function and microbial composition. As intestinal barrier function may be compromised in the~     elderly we will investigate whether the effects of pectin on selected parameters of gut~     health differ between young vs. older individuals. The primary objective of this study is to~     investigate the effects of aging on pectin-induced changes in intestinal permeability.~     Furthermore, this study has seven secondary objectives. This study conforms to a randomized,~     double-blind and placebo-controlled design including two parallel arms.The study population~     consists of Healthy human volunteers (male and female), 18-40 and 65-75 years old, BMI 20-30~     kg/m2. One group will receive 7.5 grams of pectin supplements twice daily for four weeks. A~     second group will receive 7.5 grams of placebo supplements twice daily for four weeks. Before~     and after the supplementation period, several measurements will take place. The main study~     parameter is the change in urinary sugar excretion ratio before and after the intervention~     period.~   "
90984|NCT02376257|"~     Despite advances in both pharmacotherapy and psychotherapy for major depression, non-response~     and partial-response remain relatively common outcomes, motivating the search for new~     treatments. This study is concerned with the development of one such novel treatment, the~     augmentation of exposure-based cognitive-behavior therapy (CBT) with d-cycloserine (DCS).~   "
90985|NCT02376244|"~     Cardiac rehabilitation is a program designed to help patients regain good health through~     lifestyle change after a heart attack, heart surgery or other heart problems. Patients will~     take part in exercise sessions and education lessons, tailored to meet their personal needs.~     The exercise training component of cardiac rehabilitation may be delivered as intervals of~     short intense sessions (also known as high intensity intervals) or the current standard care~     of longer but less intense sessions (moderate intense intervals). Both exercises have been~     shown to increase fitness levels and also prevent future risk of heart disease.~      The purpose of this study is to determine the efficacy and safety of high intensity interval~     exercise training (HIIT) in patients who had a recent cardiac revascularization procedure or~     recovering from a heart attack, in comparison to current standard of moderate intensity~     exercise training in terms of their physical fitness and psychological well-being.~   "
90986|NCT02376231|"~     Surgery for ovarian cancer involves a big cut on your tummy (abdomen) followed by removal of~     pelvic organs (womb, tubes and ovaries), abdominal organs (fat tissue {omentum}, appendix)~     and any other tissues involved with cancer. Several studies worldwide have reported that~     women survive longer and enjoy a longer disease free interval before their disease returns if~     all visible disease is removed at the time of their surgery. Achieving this is not easy and~     often there is widespread disease and the surgeons are unable to remove every tumour nodule~     present as it is attached to the surface of the bowel, diaphragm and other important~     Extensive surgery with prolonged operating is associated with higher risks. Plasma energy is~     commonly referred to as the 4th state of matter after solid, liquid and gas. When a gas is~     heated, it partially or wholly ionizes resulting in high energy particles like ions,~     electrons and atoms referred to as 'plasma'. PlasmaJet® (PJ) is a new device which uses fine~     jet of neutral argon plasma from the handpiece that has been shown to have the ability to~     vaporise nodules close to sensitive organs like the bowel. It may offer the potential to~     treat the tumour nodules close to sensitive areas like the bowel. There have been no studies~     exploring its role in vaporising tumour nodules and its impact on survival. The PJ may be~     used by the surgeon to seal bleeding tissues (coagulate) or to burn away thin layers of~     tissue (ablate) by vaporization. It is licensed for use to achieve effects of coagulation and~     ablation. It is similar to conventional surgical devices that are routinely used (called~     diathermy) to achieve these effects. The PJ however is slightly different in that it may also~     be used on tissue to vaporise tumour nodules in women with ovarian cancer during surgery~     though the full extent of this role remains unclear.~   "
90987|NCT02376218|"~     It is common practice to leave a chest drainage catheter after lung surgical resections to~     manage air leaks. The air leakage will usually stop in the initial postoperative days, but in~     a few patients, it will last for a longer period of time, preventing the removal of the chest~     tube that can lead to patient discomfort, increased likelihood to develop postoperative~     complications and longer length of hospital stay. Pleurodesis is an effective method to~     address postoperative air leak which consists in injecting an irritating solution into the~     chest cavity. This is not performed regularly after lung resections for different reasons~     including associated pain, costs, and fear of infections. Pleurodesis with hyperosmolar~     glucose solution have been used for years with good results in some Asian countries because~     of its simplicity and low cost. Its effectiveness for pleurodesis has been reported in cases~     of spontaneous pneumothorax and chylothorax, but its efficiency to stop air leaks in the~     postoperative period remains to be defined.~   "
90988|NCT02376205|"~     The main objective of this study is to analyze the effects of local anesthetic application~     into the retropharyngeal space and its ability to reduce dysphagia symptoms and/or occurrence~     rates in patients undergoing anterior cervical discectomy and fusion.~   "
90990|NCT02376179|"~     We have devised a simple method to continuously measure the endotracheal tube cuff pressure~     (CP) using an invasive pressure monitoring setup (IPMS), which is used routinely in the~     operating room to monitor arterial or central venous pressures. We have previously confirmed~     both in vitro and in vivo (previous IRB approved protocol), a clinically applicable agreement~     of the IPMS readings with the values obtained from a standard manometer (gold standard). In~     the current study, we will prospectively evaluate the relationship between the patient's head~     position and CP in patients undergoing otolaryngological surgery and also measure the oxygen~     and nitrous oxide saturation in the oropharynx.~   "
90991|NCT02376166|"~     Clinical trials are critical to informing the care of patients with cancer. However, only~     3-5% of patients with cancer enroll in clinical trials. Poor accrual to trials has major~     implications with regards to the pace of progress, the cost of clinical cancer research, and~     the generalizability of results. The investigators have recently shown in an analysis of~     7,776 cancer clinical trials registered on clinicaltrials.gov that approximately 20% of~     cancer clinical trials fail to complete enrollment at all; the most often cited reason was~     poor accrual.~      Prior research has identified barriers to cancer clinical trial accrual that can be generally~     categorized in the domains of availability, awareness, and acceptance. Much attention has~     been paid to the barriers involvement awareness and acceptance - however, trial availability~     is likely a rate limiting step. This pilot study is the first in a series of planned steps~     to attempt to shift the current paradigm of bringing patients to trials to bringing trials~     to patients. With the integration of telemedicine visits, the investigators aim to decrease~     the burden of participation for patients, begin to address geographic barriers, and~     ultimately improve trial accrual. In this study, men with biochemically recurrent prostate~     cancer (a rising PSA after definitive local therapy) will receive the antidiabetic drug,~     metformin. Patients will require a single on-site visit for study enrollment. The remainder~     of the 6 month study will be conducted via a HIPPA secure telemonitoring system (monthly~     visits conducted via telemedicine with tablet computers provided to each patients).~   "
90992|NCT02376153|"~     This is a prospective, randomized, blinded clinical trial to determine if the Air Barrier~     System device reduces the incidence of surgical site infection after total hip replacement,~     acetabular repair, posterior spinal fusion, and prosthetic vascular graft procedures.~   "
90993|NCT02376140|"~     Sorghum is the primary source of food for more than 300 million people in arid and semi-arid~     regions of Africa. The grain is one of the few crops that grow well in arid climates, but has~     a low content in most essential nutrients and is difficult to digest. The African~     Bio-fortified Sorghum (ABS) Project, a consortium of nine institutions led by Africa Harvest~     Biotech Foundation International, is working to develop new varieties of sorghum that are~     easier to digest and contain lower levels of phytates to improve the bioavailability of~     micronutrients.~      In order to determine their target levels, the ABS project needs reliable information on~     current levels of micronutrient deficiency and consumption patterns of sorghum and nutrients~     of interest, e.g. iron, zinc, and vitamin A in women and preschool children, which are not~     currently available in Burkina Faso.~      A background nutrition survey among children and women, comprised of two rounds, one in the~     lean season (July - August) and one in the harvest season (November - January), has been~     conducted to provide quantitative estimates of sorghum, vitamin A, iron and zinc intakes by~     women and young children from two rural provinces of Burkina Faso. The survey also had a~     biochemical component which included blood collection and analysis for indicators of~     deficiency for vitamin A, iron and zinc. Other important components of this study included~     anthropometric measurements, household and child morbidity questionnaires, and collection of~     sorghum samples for analysis of phytate, vitamin A, iron and zinc content.~   "
90994|NCT02376127|"~     The purpose of this study is to assess imaging methods including Dynamic Contrast Enhanced~     Magnetic Resonance Imaging (DCE-MRI) and perfusion for the cancer that has spread to the~     spine. The study aims to see if using these methods will help better see response to~     treatment with radiation in patients with spine metastases from any solid cancer.~   "
90995|NCT02376114|"~     Glaucoma is one of the leading causes of blindness. Ginkgo biloba may be part of an effective~     treatment strategy for glaucoma because it has been shown to improve blood flow, it has~     antioxidant properties, it can relax smooth muscle, and it can protect neurons from damage.~     The goal of our study was to determine whether Ginkgo biloba would result in increased ocular~     blood flow which may protect against glaucoma damage.~   "
90996|NCT02376101|"~     The purpose of this current study is to evaluate whether the size of the endotracheal tube~     (ETT) that is used impacts the intracuff pressure that occurs when the airway is sealed. If~     there is excessive pressure in the cuff of a smaller ETT when it is inflated, there may be~     inherent risks associated with the use of a cuffed endotracheal tube that is less than the~     appropriate size. The investigators believe that the size of the tube chosen has an impact on~     the characteristics of the inflated cuff and hence the intracuff pressure and the sealing~     pressure are variable.~   "
90997|NCT02376088|"~     Patients with GD often present with glucose dysregulation, which, according to most studies,~     is associated with islet β-cell dysfunctions, enhanced gluconeogenesis and insulin resistance~     (IR). Current studies focus mainly on IR, and a few that investigate islet β-cell functions~     show inconsistent results. This study examined the characteristics of glucose dysregulation~     in Chinese patients with GD, and furthermore evaluated the effects of thyroid dysfunction on~     islet β-cell functions and subsequently the carbohydrate metabolism.~   "
90998|NCT02376075|"~     A recent study with the DPP-IV inhibitor Linagliptin showed an improvement in the urinary~     albumin creatinine ratio in patients with diabetic nephropathy. Gutzwiller et. Al. have shown~     that GLP-1 increases renal Na secretion and inhibits renal H secretion, further indicating~     some direct renal effects of GLP-1.~      Therefore, it seems likely that treatment with the DPP-IV inhibitor Linagliptin evolves~     several beneficial effects on microvascular and endothelial function beyond glucose control~     which most probably have an impact on the progression of renal and retinal microvascular~     disease.~      The objective of this trial is to investigate the effect of Linagliptin in comparison to~     placebo on the UACR in patients with high blood pressure and an increased albumin excretion.~     Numerous, equivalent endothelial, renal, and retinal parameters serve as objectives of the~     study. All study parameters will be handled in an exploratory sense for the generation of~     models to further discuss the role of DPP-IV inhibition on renal and retinal physiology.~   "
90999|NCT02376062|"~     Globally, access to mental healthcare is often non-existent in rural, resource-deprived~     communities despite the pervasive need for services, particularly in post-conflict and~     post-disaster settings. We are developing and piloting will develop and pilot a culturally~     appropriate training model for non-specialist providers (NSPs) to deliver high-quality mental~     health care over a period of 24 months in a primary care hospital in a rural district in~     Nepal. We will employ a mixed methods framework to evaluate change in skills, knowledge, and~     attitude in NSP's, identify key mechanisms for continuum of mental healthcare delivery, and~     efficacy and cost-effectiveness in care delivery through a government hospital, clinics, and~     a network of community health workers. This integrated approach will introduce a bundled~     intervention that includes: both an on-site care coordinator and off-site psychiatric~     supervisors based in Nepal's capital, Kathmandu, weekly case conferences, and surveys of~     NSP's and clinical supervisors every six months during the study period. To learn about the~     acceptability, feasibility and challenges in the program we will also conduct Focus Group~     Discussions among the PCPs. In the last one year of the research in Achham District we have~     seen increase in knowledge efficacy and skills among the NSPs and also improved mental health~     care services at Bayalpata Hospital. Our experience in Achham motivated us to develop a~     similar program for Charikot Primary Health Center in Dolakha District. Outcomes of this~     study will focus on efficacy of this model to appropriately identify, counsel, and treat~     patients with depression, psychosis, and post-traumatic stress disorder (PTSD) through an~     integrated rural mental healthcare delivery intervention as a model for rural healthcare~     delivery.~   "
91000|NCT02376049|"~     An Explorative Clinical Trial to Evaluate an Intra Patient Comparison Design of Topical~     Agents in Adults with Mild to Moderate Atopic Dermatitis.~   "
91001|NCT02376036|"~     The primary goal of this Phase 1 study is to assess the safety and tolerability of one MGD010~     intravenous (IV) infusion in healthy adult volunteers.~   "
91002|NCT02376023|"~     The purpose of this study is to evaluate the implementation and effectiveness of text~     messages as a means for improving adherence to cervical cancer screening.~   "
91003|NCT02376010|"~     Current oral anti-coagulation for atrial fibrillation is most commonly performed with~     warfarin. Warfarin is a vitamin K antagonist that has been shown in non-randomized trials to~     increase vascular calcification. Increased vascular calcification has been tied to increased~     cardiovascular events (CVE). This study will randomize patients currently taking warfarin to~     either continue on warfarin or be switched to rivaroxaban. Rivaroxaban is an oral~     anti-coagulant that works by inhibiting Factor Xa, and has no interaction with vitamin K.~     This study is a randomized, open label study that will randomize 120 patients and have them~     undergo blood tests and a calcium scan at baseline, and again after 12 months. Patients will~     be seen quarterly for examinations, safety checks and supply of rivaroxaban, as well as~     follow up INR testing for warfarin.~   "
91004|NCT02375997|"~     The majority of patients with newly diagnosed metastatic ESCC and gastric cancer patients~     experience a number of physical and psychosocial symptoms related to their cancer. Those~     patients endure the greatest level of distress from their disease relative to other cancer~     populations in China. Although new drugs have been applied in recent years, the median~     overall survival time of metastatic ESCC and GC patients are still around 12 months.~     Therefore, it is essential to maximize their quality of life (QOL) from the time of~     diagnosis. Multiple studies demonstrate that symptoms such as pain, fatigue, and anorexia are~     prevalent at diagnosis and worsen over time. As a result, suffering increases throughout the~     course of the illness. To be most effective, palliative care with intensive symptom~     management and psychosocial support should begin at the time of diagnosis, not once~     life-prolonging therapies have failed. And some studies have revealed that early palliative~     can even prolong the overall survival time in advanced lung cancer. The investigators then~     initiated a randomized phase III clinical trial with standard oncology care plus early~     palliative care or not in metastatic esophageal carcinoma and gastric cancer to observe~     whether the early palliative can improve the QOL and even prolong the overall survival time~     in those patients~   "
91005|NCT02375984|"~     The purpose of this protocol is to determine whether autologous TIL infused in conjunction~     with systemic high-dose IL-2 after non-myeloablative chemotherapy with cyclophosphamide and~     fludarabine can cause consistent and durable objective responses in patients who have~     metastatic melanoma at the John Wayne Cancer Institute (JWCI).~   "
91006|NCT02375971|"~     The purpose of this study is to determine if intravitreal ranibizumab is superior to laser~     ablation therapy in the treatment of retinopathy of prematurity (ROP).~   "
91007|NCT02375958|"~     A first-in-human sttudy using PCA062 in patients with p-CAD positive solid tumors.~   "
91008|NCT02375945|"~     Swelling is a common problem after knee arthroplasty often leading to delayed wound healing,~     lasting functional impairment and hematoma.~      Due to this complications, sometimes the risk for deep venous thrombosis is raised. This~     study investigates a new self adjustable device to reduce swelling more effective~     postoperatively. The investigators compare the new device to the current general practice by~     using a standard class 1 elastic stocking~   "
91009|NCT02375932|"~     Patients with type 2 diabetes are increasingly complex. Lack of time to address all patient~     and provider priorities during primary care visits represents a barrier to effective primary~     care. The investigators propose to design, implement, and evaluate in a randomized clinical~     trial a web-based tool linked to the electronic health record (EHR) that will enable complex~     patients to easily define care priorities for their upcoming visit.~   "
91021|NCT02375776|"~     This study evaluates a smart phone based mobile application designed for patients with Renal~     Cell and Prostate Cancer taking oral anti-cancer medications. (OAMs) All participants will be~     patients at the Dana Farber Cancer Institute in Boston, Massachusetts. Half of the~     participants will use the mobile application for a 3 month period along with their usual~     care. Half of the participants will just receive usual care.~      The investigators hope to show that cancer patients taking OAMs who use the mobile~     application will be better connected to their care team and will develop increased competency~     for self-care which will primarily increase medication adherence.~   "
91050|NCT02375399|"~     Echocardiography parameters for cardiac dyssynchrony had no predictive value in current~     multicentric prospective studies concerning cardiac resynchronization therapy. Comprehensive~     echocardiography and new parameters as 2D and 3D strain, as well as 3D echo have been~     analyzed, but their definite value has not been proven yet.~   "
91010|NCT02375919|"~     The Pulmonary Embolism Rule Out Criteria (PERC) is an 8-item rule, that was derived and~     tested to rule out the diagnosis of Pulmonary Embolism (PE) in the Emergency Department (ED)~     amongst low risk patients. Even though meta analyses have confirmed the safety of its~     utilization, equipoise remains - especially in European country where the prevalence of PE is~     higher than in the US- on whether this rule could be safely applied to all low risk emergency~     patients with a suspicion of PE.~      The PROPER Trial is a non inferiority , cluster randomized trial. All centers will recruit~     patients with a suspicion of PE and a low pre test probability. To rule out the diagnosis of~     PE, center will use the usual diagnostic strategies with D-dimeres measurement for 6 months,~     and PERC based strategy for 6 months.~      In the control group (usual strategy), patients will be tested for D-dimeres, followed if~     positive by a Computed Tomography of Pulmonary Artery (CTPA).~      In the intervention group (PERC Based), patients will be first assessed with PERC score. If~     PERC=0, then the diagnosis of PE will be exclude with no supplemental investigations. If~     PERC>0, then patients will undergo the usual strategy, with D-dimeres measurement +/- CTPA.~      The primary outcome is the failure percentage of the diagnostic strategy, defined as~     diagnosed deep venous thrombosis (DVT) or PE at 3 month follow up, among patients for whom PE~     has been initially ruled out.~   "
91011|NCT02375906|"~     Hepatitis delta is a major health problem, not only because of the severity of the disease,~     but also due to the lack of effective antiviral treatment. To improve the current therapeutic~     options, a better understanding of the pathophysiology is essential. Reliable research in~     this direction is only possible with large patient study groups. However, given the~     geographic distribution of hepatitis delta, larger patient cohorts would only be possible~     through multicenter collaboration.~   "
91012|NCT02375893|"~     The purpose of this study is to describe the composition of bile acids and the gut microbiota~     comparing two populations: patients with coronary atheroma and the healthy subjects.~      Our hypothesis is based on the demonstration of the anti atherogenic and anti inflammatory~     effect of certain bile acids, and the role of the gut microbiota in the metabolic regulation.~   "
91013|NCT02375880|"~     DKN-01 is a humanized monoclonal antibody (Mab) with neutralizing activity against Dkk-1 and~     is being developed as an anti-neoplastic agent. This study is designed to evaluate the~     safety, tolerability, pharmacokinetics, and anti-tumor activity of DKN-01 in combination with~     gemcitabine and cisplatin in patients with carcinoma primary to the intra- or exta-hepatic~     biliary system or gallbladder.~   "
91014|NCT02375867|"~     Fulminant hepatic failure (FHF) in children is a potentially devastating disease. The~     mortality rate may reach 80-90% in the absence of liver transplantation. Liver injury is~     considered to be mainly immune mediated with augmentation of cytolytic pathways of infected~     hepatocytes. For that, it is suggested that corticosteroids modulate the activity of the~     disease by suppressing the immune system.~   "
91015|NCT02375854|"~     The objective of this protocol is to investigate the impact of prematurity, with or without~     associated acute kidney injury (AKI), on the future risk of chronic kidney disease (CKD) by~     establishing a patient registry and biorepository. Serum and urine samples will be collected~     serially from premature infants admitted to the neonatal intensive care unit (NICU) at Albert~     Einstein College of Medicine/Weiler Hospital and subsequently followed in the NICU follow-up~     and pediatric nephrology ambulatory subspecialty clinics. The biorepository will be linked to~     a comprehensive clinical database.~   "
91016|NCT02375841|"~     The purpose of this study is to learn more about the way physicians communicate with brain~     tumor patients. This study will look at how oncologists provide information about brain~     tumors, brain scan results, and treatment options. This study will look at how oncologists~     provide information about brain tumors, brain scan results, and treatment options.~     Ultimately, the investigators hope to use these findings to improve communication between~     patients, caregivers and their doctors.~   "
91017|NCT02375828|"~     The understanding of the molecular mechanisms of neonatal diabetes has deeply changed the~     therapy of patients carrying mutations in the K-ATP channel. Indeed, those patients are not~     treated anymore by insulin injections but by glibenclamide an oral anti-diabetic drug widely~     used in type 2 diabetes. Anyway, its galenic form (pills of 5 mg) is not suitable for~     children and difficult to administrate to infants or young children. The purpose of this~     study is to determine if a new galenic form of this durg is more suitable and as efficient as~     pills in children with neonatal diabetes.~   "
91018|NCT02375815|"~     This study is designed to answer a key question in the field of implementation science.~     Specifically, it seeks to determine if a proposed model for the implementation and scale-up~     of healthcare innovations (the AIDED model) is effective and useful. To fully evaluate the~     potential of this model, the investigators will conduct a multi-year study comprising 3~     phases. This proposal represents the first of these phases.~   "
91019|NCT02375802|"~     This pilot study of 12 patients (6 control, 6 experimental) will test the safety and efficacy~     of applying autologous, adipose-derived stromal cells (ASCs), uncultured, on a Stage III or~     IV pressure ulcer. Patients in both groups would undergo a minimal risk liposuction procedure~     to withdraw 50-100 cc of adipose tissue. The tissue would be processed to extract the stromal~     layer of cells that contain stem cells. The ASCs would be injected into a fibrin sealant to~     be applied to the wound. Patients would be followed for 6 weeks to assess wound healing and~     tolerance of the treatment.~   "
91020|NCT02375789|"~     This study will be a randomised placebo controlled trial examining the effectiveness of using~     an intranasal cooling device (the RhinoChill) in providing relief of pain and symptoms of~     acute migraine. It will involve using two nasal catheters to cool the nasal cavity which~     provides localised cooling of the local nasal tissue and the blood vessels which supply blood~     to the brain. This cooling effect will cause the blood vessels to constrict as well as~     stimulating special cold receptors that are thought to be involved in the relief of migraine,~     thereby providing both pain and associated symptomatic relief. Ninety patients will be~     randomised in a 1:1 fashion, clustered to three different recruitment sites. The patients~     will have a 30 day period of data collection for their current migraine frequency, treatment~     and response to medication (with a minimum of 2 migraine attacks recorded) before starting~     the treatment phase with the RhinoChill Device. Treatment will be for 2 migraine attacks.~     Only a single treatment is allowed for the first attack, but on the second attack the patient~     may deliver 2 treatments with a gap of at least 2 hours between treatments.~   "
91022|NCT02375763|"~     Children will be recruited from the pediatric dentistry clinic of Marquette University at~     their first or recall appointment and will be asked to fill a questionnaire regarding their~     dietary habits. Afterwards a dietary analysis will be performed using a computer software,~     developed for this study and dietary instructions will be given to the children.~   "
91023|NCT02375750|"~     The primary objective of the study is to proof the successful use of Geistlich Bio-Oss® and~     Geistlich Bio-Gide® (already registered medical devices) in bony peri-implant defects due to~     peri-implantitis disease.~   "
91024|NCT02375737|"~     The investigators propose to evaluate the implementation of an efficacious medication~     adherence program in a group at high risk for CVD. The program involves patients~     receiving/responding to e-reminders to take CVD medications via patient-selected technology~     [mobile/web-based applications, short message service (SMS; text messaging), interactive~     voice response (IVR), or e-mail] supported by a tailored, monthly, self-management program~     administered by either research staff or a case manager staff member from the Duke Outpatient~     Clinic via the telephone. This is a hybrid type II implementation science study.~   "
91025|NCT02375724|"~     The aim of the present study is to evaluate the effect of aclidinium bromide 400 μg BID~     compared with placebo on COPD symptoms in a symptomatic patients population with moderate~     COPD and chronic bronchitis, and particularly assess the effects in cough by using specific~     tools to assess the occurrence and impact of this relevant COPD symptom.~   "
91026|NCT02375711|"~     The aim of this study is to investigate the role of immunosenescence in the HBV vaccination~     response in patients with renal insufficiency.~   "
91027|NCT02375698|"~     This is a Phase I, double-blind, randomized, placebo-controlled safety and immunogenicity~     study in adults who have recently been successfully treated for drug-susceptible pulmonary~     Tuberculosis (TB). The safety and immunogenicity profile of escalating doses of AERAS-456 in~     HIV-negative subjects recently treated for drug-susceptible pulmonary TB will be~     investigated. The study will be conducted at one or more sites in South Africa.~   "
91028|NCT02375685|"~     The objective of this study is to evaluate long-term safety of gevokizumab in patient with~     chronic non-infectious uveitis who previously well tolerated the study drug and may benefit~     from longterm treatment with gevokizumab.~   "
91029|NCT02375672|"~     This is a multi-institutional, single arm, open-label, phase II study, including a safety~     run-in cohort. No randomization or blinding involved.~   "
91030|NCT02375659|"~     Across the U.S. Skin of Color (SOC) clinics have been established with the goal of providing~     medical care and supporting research related to patients with skin of color. There have been~     no formal studies evaluating why patients seek medical care at SOC clinics or treatment~     outcomes. Reasons may include past experiences with other providers, the perception that~     providers working in these clinics have a special interest or knowledge in caring for~     patients with skin of color and thus may provide better care, the expectation of cultural~     sensitivity, the hope that their provider may have a similar ethnic background, and/or ease~     of communication with their provider. Through focus group discussions we aim to identify the~     factors influencing a patient's choice to seek medical care at a SOC clinic and to gain~     insight into the presence and impact of racial concordance between provider and patient. The~     current study will focus on self-identified African American patients with interest in~     conducting similar sessions with patients of other ethnicities and races in the future.~   "
91031|NCT02375646|"~     One of the well-known of complications post colonic polypectomy is bleeding usually occuring~     in the 2-week period following the procedure. Patients treated with oral anticoagulation~     (e.g. Warfarin) are a special and challenging patient group due to the need on the one hand~     to prevent thromboembolic events, and on the second hand to minimize the risk of~     post-polypectomy bleeding. Current practice guidelines recommend holding Warfarin treatment~     while bridging with LMW Heparin while resuming Warfarin treatment following the procedure.~     This practice was found to be associated with a much higher rate of bleeding compared with~     continuing Warfarin in a recent prospective trial in pacemaker transplanted patients. The~     fact that most post-polypectomy bleeding occurs within the 2-week period further questions~     the current practice of periprocedural bridging therapy. the investigators therefore~     hypothesize that patients with continuous Warfarin treatment may have similar~     post-polypectomy bleeding rates compared to patients receiving bridging therapy with LMW~     Heparin.~      This is a multicenter single-blinded prospective randomized trial comparing small~     post-polypectomy (polyps<10mm) bleeding rates between two groups of patients: Continuous~     therapy with Warfarin, vs. LMW Heparin therapy while withholding Warfarin therapy (current~     practice).~   "
91032|NCT02375633|"~     A Multicenter, Randomized, Double-blinded, Parallel, Active-controlled, Phase III Clinical~     Trial to Evaluate the Efficacy and Safety of DW-330SR2 and Pelubiprofen in Chronic Back Pain~     Patients.~   "
91033|NCT02375620|"~     The study was evaluated as the optimal dose for the treatment of SGA short stature children~     by Pegylated Somatropin, initially evaluated its efficiency and safety for the treatment of~     SGA short stature children and provided scientific, reliable basis for phase III clinical~     trials for dose selection.~   "
91034|NCT02375607|"~     The purpose of this study is to determine the correlation between preoperative algometer~     score and the amount of postoperative analgesic consumption. The algometer score of the~     patients will be recorded in the preoperative period. In postoperative period, the analgesic~     consumption rate will record and compare with the algometer score.~   "
91035|NCT02375594|"~     Exercise park equipments for the elderly are designed taking into account the physical and~     cognitive capabilities and needs of elderly individuals. These equipments are usually built~     in public spaces, and may be part of public health initiatives to promote active lifestyles~     in the elderly.~      Previous research has provided clear evidence on the short-term efficacy of exercise programs~     in improving physical function and level of physical activity in community-dwelling elderly.~     The goal of this randomized clinical trial is to assess whether an exercise intervention~     conducted in an exercise park equipment is able to achieve sustained improvements in physical~     function and level of physical activity, that are maintained for at least 3 months after the~     end of the intervention. The target population are community-dwelling elderly that are~     insufficiently active.~   "
91036|NCT02375581|"~     To investigate the efficacy and toxicity of EGFR tyrosine-kinase inhibitor (Icotinib) with~     concurrent radiotherapy in older patients with esophageal cancer.~   "
91037|NCT02375568|"~     According to many recent research, mesenchymal stem cells (MSC) isolated from synovial~     membrane and infrapatellar fat pad have higher ex vivo proliferation capacity, multipotency~     and ability to undergo chondrogenesis.~      Based on this concept, the investigators plan to get two removed tissues (synovial membrane~     and infrapatellar fat pad) from patients who have an operation of total knee replacement. The~     investigators are going to isolate and expand MSC from these two tissues respectively, and~     then compare the chondrogenesis ability for clinical application. In the other hand, the~     investigators plan to build techniques and procedures which comply with Good Tissue~     Practices (GTP)~   "
91038|NCT02375555|"~     This research study is evaluating a combination of four drugs -- lenalidomide, bortezomib,~     dexamethasone and elotuzumab -- as therapy for newly diagnosed multiple myeloma.~   "
91039|NCT02375542|"~     This study will analyse factors contributing to cardiac re-operation to determine causative~     effects~   "
91040|NCT02375529|"~     Background: Single-incision laparoscopic cholecystectomy (SILC) is increasingly being used as~     a minimally invasive surgery with potential benefits over 4-port laparoscopic cholecystectomy~     (LC) in terms of postoperative pain and faster recovery.~      Methods: Seventy-three patients with symptomatic cholelithiasis were randomized to SILC~     (n=37) or LC (n=36). Data measures included operative details, adverse events, postoperative~     pain and analgesic requirements, success of the ambulatory process, return to normal activity~     and return to work, cosmetic results and quality of life score.~   "
91041|NCT02375516|"~     The planned research aims to delay the onset of drug use and reduce harmful use and abuse~     among Hispanic youths. The culturally-tailored prevention program will be delivered to youths~     by computer. Over 5 years, the program will be developed and tested in a randomized clinical~     trial. The intervention program will include 10 initial sessions, followed by annual booster~     sessions. Outcome measurements will involve baseline, post-intervention, and three annual~     follow-up data collections.~      The study's primary hypothesis is that rates of 30-day alcohol and drug use will be lower~     among participants assigned to receive the intervention. If proven to be efficacious, the~     program will be revised and disseminated nationally.~   "
91042|NCT02375503|"~     The primary objective of this randomized, double-blind, placebo controlled trial is to~     determine the efficacy of a once per day calcium (1000mg) and vitamin D (1000IU) fortified~     food product on bone turnover markers, including parathyroid hormone (PTH) and~     microarchitecture during Army basic military training (BCT). The investigators hypothesize~     that consumption of a once daily calcium and vitamin D fortified food product will stabilize~     PTH and contribute to improved bone microarchitecture compared to placebo. The results will~     determine the efficacy of daily supplementation with calcium and vitamin D on bone turnover~     markers as well as provide novel data regarding microarchitectural changes during BCT as~     assessed by high resolution peripheral computed tomography (HRpQCT) scanning.~   "
91043|NCT02375490|"~     Childhood obesity is one of the greatest challenges facing public health and recent evidence~     shows it begins in preschool aged children. It has been suggested that interventions be~     carried out to improve physical activity and healthy eating behaviour among young children.~     This study aims to fully evaluate Healthy Start, a multilevel physical activity and healthy~     eating intervention for preschool aged children. It is hypothesized that the Healthy Start~     intervention will improve both eating and physical activity behaviors of children attending~     early childcare centers because of its influence on multiple factors.~   "
91044|NCT02375477|"~     This clinical trial studies how well inter-disciplinary educational methods work in improving~     adherence to isolation protocols in patients with Clostridium (C.) difficile infections. An~     inter-disciplinary educational method may help to prevent the spread of infection.~   "
91045|NCT02375464|"~     Gallium-68 DOTATOC is a material used to find neuroendocrine tumors (NETs) using positron~     emission tomography (PET scan). The material has already been shown to be better than the~     currently available imaging agents. This study is designed to evaluate the clinical impact of~     PET CT scanning using this agent in the evaluation and management of patients with NETs.~   "
91046|NCT02375451|"~     Radioiodine (I-131) therapy for thyroid disease is known to decrease salivary function in~     adult patients. The impact of pediatric I-131 exposure on salivary function is unknown. The~     investigators goals are to answer this question by measuring salivary gland function before~     and after I-131 administration in children who receive radioiodine therapy at our hospital~     for thyroid disease.~   "
91047|NCT02375438|"~     The aim of this study is to assess nutritional intake (quantitatively and qualitatively),~     nutritional state and body composition of patients suffering from mitochondrial cytopathy,~     compared to healthy controls. The energy intake will be calculated through dietary protocols,~     the energy expenditure by indirect calorimetry and body composition will be performed with~     bio-impedance analysis. Further on, the investigators expect to be able to provide~     nutritional counselling to this population in order to increase energy and protein intake,~     which may improve health and well-being.~   "
91048|NCT02375425|"~     The development of surrogates to predict HIV prevention product safety and efficacy is a high~     priority. An ex vivo challenge model is one such promising surrogate. Colonic tissue exposed~     to rectally applied microbicides in vivo and then challenged with HIV in the lab showed~     significant reduction in HIV replication when compared to tissue exposed to placebo gel.~     Currently, the ex vivo challenge model for ectocervical and vaginal tissue is under~     development at the Dezzutti lab at the Magee Womens Research Institute in Pittsburgh, PA.~     Currently the Reproductive Infectious Disease Research Group is conducting a study designed~     to answer important questions about the ex vivo challenge model:which HIV virus is the best~     to use in the laboratory and what is the best indicator of HIV infection. The proposed study~     delineated here will investigate the effect of BV, HSV and contraceptive use on the model .~     There will be two arms to the study; the first will investigate the impact of HSV and BV~     status and the second, contraceptive use. Vaginal and cervical biopsies will be collected~     from participants for the ex vivo challenge model.~   "
91049|NCT02375412|"~     The purpose of the study is to confirm the hypothesis that a dysfunction of the autonomic~     nervous system could complicate the postoperative course in the patient undergoing surgery.~     Measurement of heart rate variability (HRV) is a non-invasive method for evaluation of the~     autonomic nervous system.~   "
91051|NCT02375386|"~     This is study testing the feasibility of collecting neurophysiological measures of outcome~     related to body-based interventions for low back pain. The investigators will collect fMRI~     and psychophysical data about pain sensitivity before and after the interventions.~     Participants will be randomly assigned to either spinal manipulation or therapeutic touch~     groups. Participants will attend two practice sessions prior to the first data collection.~     There will be two follow-up assessments.~   "
91052|NCT02375373|"~     This prospective study will assess the effects of adding legumes, especially chick peas, to~     the diet of healthy adults on the commensal bacteria from feces of human subjects and~     resulting self-reported GI symptoms as well as markers of immune function.~   "
91053|NCT02375360|"~     Patients with food allergy and their parents will answer a food allergy quality of life~     questionnaire that will be translated to Hebrew and validated. Questionnaires will be filled~     also by patients undergoing oral immunotherapy (OIT).~   "
91054|NCT02375347|"~     This prospective study will assess the effects of adding legumes, especially chick peas, to~     the diet of healthy adults on the commensal bacteria from feces of human subjects and~     resulting self-reported GI symptoms as well as markers of immune function.~   "
91055|NCT02375334|"~     This research trial studies an adherence monitoring system in managing myelosuppression in~     patients with newly diagnosed malignant gliomas who are receiving temozolomide and radiation~     therapy. The development of an adherence monitoring system may help doctors more effectively~     utilize electronic medical records to manage myelosuppression during standard treatment with~     temozolomide and radiation therapy in patients with malignant gliomas.~   "
91056|NCT02375321|"~     Many researches have shown that patients with Obstructive Sleep Apnea (OSA) and often also~     the family members have a decreased quality of life, problems related to the sexual sphere,~     depressive disorders and anxiety problems. To date still remains controversial the~     relationship between OSA and quality of life, also the link between sleep apnea syndrome and~     depression is unclear.~      In adult patients with OSA the treatment of choice is the application of a continuous~     positive airway pressure (CPAP: Continuous Positive Airway Pressure) at the opening of the~     airways. With the CPAP treatment the sleep normalizes and daytime sleepiness fades or~     disappears.~      Many studies have shown that this treatment determines improvement of the medical and~     psychological status. However, the rate of non-adherence to treatment reported in the~     literature is about 46-83%, considering as adherence the use of CPAP for at least 4 hours per~     night. A recent study has shown that CPAP used as a single treatment in patients with OSA and~     depression, has reduced the depressive symptoms but in a significant percentage of patients~     (42%), the depressive symptoms remained unchanged or worsened. At the present time have not~     been published, to our knowledge, studies concerning the effectiveness of the combined~     treatment of CPAP and psychological support on the mood and on the quality of life OSA~     patients.~      Therefore the aim of this study is to evaluate the effects of the combined treatment with~     CPAP and psychological intervention with cognitive behavioural therapy on the mood and on the~     quality of life of OSA patients.~   "
91057|NCT02375308|"~     The purpose of the study is to compare the efficacy of an Hypnotherapeutic Treatment of~     Depression to Cognitive Behavioral Treatment of Depression in patients with mild to moderate~     Major Depressive Episodes.~   "
91058|NCT02375295|"~     The aim of this research is to determine an effective antibiotic regimen following definitive~     surgical therapy of kidney stones caused by bacterial infection (struvite stones).~   "
91059|NCT02375282|"~     Ambulation following surgery has been found to be beneficial for patients; however, nurses~     and doctors struggle with getting post-operative, hospitalized patients to walk on their own.~     One promising strategy to address this might be an ambulation orderly, an employee whose~     single responsibility is to assure that patients walk 3-4 times per day. However, the effect~     of the ambulation orderly on post-operative physical activity has not yet been described. It~     is important to quantify what the ambulation orderly does in order to assess if this is an~     effective method for helping patients walk. As a result, the investigators will perform a~     pilot randomized controlled trial to test the effects of an ambulation orderly in patients~     hospitalized with recent cardiac surgery. Half of the patients will be assigned to walk with~     the ambulation orderly 3-4 times/day and the control group will be given standard nursing~     encouragement and assistance and encouragement to walk. The investigators will evaluate the~     average total daily step counts (over the hospital course, usually 4-7 days) and the change~     in walking distance between a baseline and a final 6 minute walk test. The investigators will~     also evaluate exercise physiologic parameters (heart rate, oxygen saturation) during~     ambulation, patient functional independence, and patient satisfaction.~   "
91060|NCT02375269|"~     Remote Ischemic Preconditioning (RIPC) is mediated by intermittent brief episodes (5-10~     minutes) of short ischemia in a limb (i.e. arm), followed by reperfusion. For this purpose in~     3-4 cycles, a tourniquet is insufflated to suprasystolic pressure levels for 5 minutes and~     deflated for 5 minutes afterwards. The ischemic episodes are known to stimulate platelets and~     factors platelet dependent factors such as Serotonin and VEGF. These humoral factors have a~     systemic effect and have the potential to protect target organs (i.e. heart, kidney, liver)~     remote to the ischemic limb.~      The purpose of this randomized controlled study is to investigate the influence and impact of~     RIPC on postoperative complications in patients undergoing visceral surgery~   "
91061|NCT02375256|"~     Healthy adults received BCG on Study Day -84, followed by randomization on Study Day 0 to~     receive 2 booster doses in a blinded fashion of either AERAS-402 (N=9) or placebo (N=2) on~     Study Days 0 and 28. Subjects were followed for a total of 98 days.~   "
91062|NCT02375243|"~     The aim of the study is to evaluate the efficacy of dexmedetomidine in reducing the need for~     sedatives and analgesics in the immediate post-operative period in children who underwent~     surgical correction of complex congenital heart disease~   "
91074|NCT02375087|"~     Up to one-third of patients with myotonic dystrophy type 1 die suddenly mainly from~     arrhythmias. Sleep apnea is prevalent in myotonic dystrophy (DM1) patients. Among the serious~     complications from sleep apnea, the most alarming are arrhythmias and sudden cardiac death~     (SCD). Diagnosis of sleep apnea using simple tools in ambulatory cardiology practice may~     improve therapy of cardiac arrhythmias in patients with DM1~   "
91063|NCT02375230|"~     Establishing breathing after birth is vital for survival and long-term health of premature~     babies. 10% of all preterm babies fail to breathe after birth and require help with~     breathing. When infants need help with breathing the clinical team will place a small mask on~     the babies face to give some breaths to help the baby breath (what the investigators call~     mask ventilation).~      This procedure is done million times a day around the world and several times a day here at~     the Royal Alexandra Hospital. Providing these breaths via mask ventilation is the most~     difficult step in helping a baby breath at birth. If this is provided wrongly then baby does~     not receive enough oxygen, which could damage the brain and even cause death.~      To keep the skill level of every staff member up-to-date every staff member is required to~     re-train this rescue breaths via mask ventilation once every two years.~      The investigators believe this is not enough and that daily trainings are necessary to keep~     your skills up-to-date.~      The investigators aim to compare to different teaching techniques using daily trainings to~     see if either improves the skills of the resuscitator providing mask ventilation~      The study will last 7 month (baseline observations (2 months), intervention period (3~     months), After trial period (2 months)~      The investigators will use our routinely used equipment to record neonatal resuscitation and~     the investigators also routinely make video recordings to evaluate performance during~     resuscitation.~   "
91064|NCT02375217|"~     Prospective Randomized non inferiority Trial involving adult patients undergoing elective~     surgery under general anesthesia.56 Patients will be enrolled in 2 groups : full dose~     sugammadex vs half dose sugammadex for reversal of NMB.~   "
91065|NCT02375204|"~     This randomized phase III trial studies how well standard-dose combination chemotherapy works~     compared to high-dose combination chemotherapy and stem cell transplant in treating patients~     with germ cell tumors that have returned after a period of improvement or did not respond to~     treatment. Drugs used in chemotherapy, such as paclitaxel, ifosfamide, cisplatin,~     carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either~     by killing the cells, by stopping them from dividing, or by stopping them from spreading.~     Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by~     stopping them from dividing or killing them. Giving colony-stimulating factors, such as~     filgrastim or pegfilgrastim, and certain chemotherapy drugs, helps stem cells move from the~     bone marrow to the blood so they can be collected and stored. Chemotherapy is then given to~     prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the~     patient to replace the blood-forming cells that were destroyed by the chemotherapy. It is not~     yet known whether high-dose combination chemotherapy and stem cell transplant are more~     effective than standard-dose combination chemotherapy in treating patients with refractory or~     relapsed germ cell tumors.~   "
91066|NCT02375191|"~     The purpose of this study is to evaluate the effect of epidural dexmedetomidine added to~     ropivacaine in pediatric orthopedic surgery~   "
91067|NCT02375178|"~     This is a three arm randomized trial. The aim is to evaluate the antimicrobial activity of~     chlorhexidine and polyhexamethylene biguanide oral antiseptics on the microorganisms of the~     oral cavity. A total of 30 healthy volunteers will be enrolled and randomly allocated to~     control group (CG, n=10), which will be instructed to rinse the mouth with 10ml of a sterile~     saline solution for one minute, to chlorhexidine group (ClG, n=10), which will be instructed~     to rinse the mouth with 10ml of an 0.12% chlorhexidine solution, for one minute, or to~     polyhexamethylene biguanide group (PG, n=10), which will be instructed to rinse the mouth~     with 10ml of an 0.07% polyhexamethylene biguanide solution, for one minute. Samples of saliva~     will be collected before the mouth wash and after 30, 60 and 180 minutes. Samples will be~     plated on manitol agar, mitis salivarius agar, EMB agar and Sabouraud agar. Samples will be~     processed by a blinded microbiologist.~   "
91068|NCT02375165|"~     Acquired lymphedema is a disease that causes chronic swelling of the limb(s). It is~     frequently under-recognized or misdiagnosed. This study is designed to lead to the~     development of an accurate, noninvasive, blood test to allow testing for lymphedema.~   "
91069|NCT02375152|"~     Obsessive-compulsive disorder (OCD) is a severely disabling psychiatric disorder with a~     worldwide lifetime prevalence of 2-3% (Islam et al., 2015).Despite the efficacy of~     pharmacological and behavioural treatment methods for most OCD patients, roughly one third do~     not demonstrate significant symptom improvement, even after aggressive treatment (Foa et al,~     2007). The effectiveness of neurosurgical treatment methods (including ablative surgery) for~     those with severely disabling treatment resistant OCD is substantiated by clinical research~     (Greenberg, Rauch & Haber, 2010). The brain target of this procedure is usually the area~     between the anterior and middle third of the anterior limb of the internal capsule.~   "
91070|NCT02375139|"~     This Phase I clinical study is to evaluate the safety/tolerability and pharmacokinetics of~     DA-1229_01(Evogliptin/Metformin XR 2.5/500 mg x 2 tablets).~   "
91071|NCT02375126|"~     In this study, the investigators will collect EEG data in normal, healthy volunteers without~     a history of prior brain injury. This data will be analyzed by computer (quantitative, or~     qEEG) and stored in a normative database so that, in the future, the investigators can better~     understand and characterize the brain damage that can result from carbon monoxide (CO)~     poisoning and other types of brain injury.~   "
91072|NCT02375113|"~     This is a pilot study examining the effect of dietary supplements that contain soy products.~     The purpose of this study to find out if soy supplementation can help to reduce the storage~     of a certain kind of fat on the body, visceral fat. Visceral fat is fat found deep in the~     abdomen; it has the potential to increase the risk of certain health problems.~   "
91073|NCT02375100|"~     This study compares efficacy of transversus abdominis plane block and ilioinguinal nerve~     block for postoperative pain in patients undergoing inguinal herniorraphy with spinal~     anesthesia. One-third of the patients will receive standard postoperative pain~     regimen(control group), one-third will receive a transversus abdominis plane block (with~     ultrasound guidance) and the last group will receive an ilioinguinal nerve block(with~     ultrasound guidance) in addition to standard postoperative pain regimen. This study is a~     Randomized prospective open-label controlled study.~   "
91527|NCT02369159|"~     This study will evaluate the safety, pharmacokinetics and effectiveness of a single dose of~     IV peramivir compared to a standard 5 day course of oral oseltamivir in the treatment of~     pediatric subjects with acute uncomplicated influenza. Two thirds of the participants will~     receive peramivir, while one third will receive oseltamivir.~   "
91075|NCT02375074|"~     The share of young workers falling into early work disability is an increasingly important~     problem in Norway. Early withdrawal or exclusion from the labor market leads to large~     individual and societal costs. The SEED-trial is a randomized controlled trial aiming to~     provide evidence-based knowledge about different approaches to prevent permanent disability~     and increase labor market participation in this important and vulnerable group. The trial~     includes young adults aged 18-30 years who are at risk of early work disability, and the~     participants will be randomly assigned to 1 of 2 interventions, both aimed at facilitating~     participation in working life:~        1. Traditional Vocational Rehabilitation (TVR), offering training and preparation for the~          labor market in a sheltered environment~        2. Supported Employment (SE), focusing on competitive employment in real-life settings~          without long-lasting preceding training~      Both interventions are currently provided by The Norwegian Labor and Welfare Administration~     (NAV). Supported Employment was introduced recently and is currently being implemented, while~     traditional vocational rehabilitation with sheltered employment has been around for years.~     However, no Norwegian controlled studies have been conducted on these practices in this~     population. The current study will therefore provide new knowledge of the effect of~     traditional as well as new and promising interventions to increase labor market participation~     and prevent early disability.~   "
91076|NCT02375061|"~     This study is aimed to test the efficacy of a Positive Psychology Intervention (Best Possible~     Self, BPS) over optimism, future expectancies and positive affect at mid-term, in comparison~     to a control group, in fibromyalgia patients. The principal hypothesis is that the BPS~     intervention will enhance significantly the levels of optimism, positive future expectancies~     and positive affect in comparison to the Control group at short and mid-term.~   "
91077|NCT02375048|"~     Selected patients with early stage breast cancer undergone conservative surgery were~     randomized in two arms: Hypofractionated Whole Breast Irradiation versus Accelerated Partial~     Breast Irradiation.~   "
91078|NCT02375035|"~     To evaluate the use of the CAMbridge PROstate Biopsy devicE (CAMPROBE) as a method of~     undertaking prostate biopsy as part of their clinical management.~   "
91079|NCT02375022|"~     This single-arm pilot study tries to invesitgate how well giving icotinib with rh-endostatin~     (Endostar®) works in treating patients with advanced stage non-small cell lung cancer (NSCLC)~     with epidermal growth factor receptor (EGFR) activating mutations. Icotinib may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth.~     Anti-angiogeneiss drug, such as rh-endostatin, can block tumor growth by inhibiting the~     ability of tumors to grow new blood vessels and spread. It is not yet known whether icotinib~     is more effective when given with rh-endostatin in NSCLC patients with EGFR activating~     mutations.~   "
91080|NCT02375009|"~     This proposal aims to evaluate selective laser trabeculoplasty (SLT) as a safe and effective~     therapy to control open-angle glaucoma and reduce the risk of progression to visual~     dysfunction or blindness in the African-derived developing world. If funded, this work will~     complete the characterization of SLT's safety and efficacy profile as a means of long-term~     disease control in this population. This work will support the translation of SLT into a~     structured public health initiative to reduce glaucoma-related vision loss throughout the~     African-derived developing world.~   "
91081|NCT02374996|"~     Insulin is a hormone produced by the body to regulate blood sugar. Insulin resistance is a~     state when the body is not using insulin correctly, and more insulin is needed to maintain~     normal blood sugar. Insulin resistance is common in bipolar patients and even more common in~     bipolar patients treated with antipsychotics. Insulin resistance from antipsychotics can lead~     to type 2 diabetes, metabolic syndrome and cardiovascular disease and is known to lead to~     worse psychiatric outcomes (less mood stability) and lower life expectancies in bipolar~     disorder. Abnormal regulation of the folate cycle is known to play a role in~     antipsychotic-induced insulin resistance and the main endpoint to the folate cycle is the~     production of methyl donors for DNA methylation. DNA methylation is critical as it regulates~     how genes are expressed. Thus, changes in DNA methylation may play a role in the disease~     process of antipsychotic-induced insulin resistance. The purpose of this study is to examine~     the differences in the DNA methylation of candidate tissues known to have a role in the~     development of insulin resistance. The three groups of bipolar patients to be studied are 1)~     antipsychotic treated patients with impaired glucose tolerance, 2) antipsychotic treated~     patients with normal glucose tolerance and 3) lithium treated patients with normal glucose~     tolerance. Group 1 will be compared to groups 2 and 3 in order to assess how DNA methylation~     in the skeletal muscle and fat tissue changes due to medication effects (group 2 vs. 3) and~     medication side effects (group 1 vs. 2). Secondary analyses include the analysis of how fats~     are processed in skeletal muscle and fat tissue in relation to antipsychotic-induced insulin~     resistance and the correlation of DNA methylation across different tissues. The investigators~     hypothesize that antipsychotic-induced insulin resistance is to due changes in the way DNA is~     expressed (through epigenetic changes) which causes further changes in the way fats are~     processed in the body eventually leading to insulin resistance. This work is based on~     preliminary findings however further work is needed to identify the true mechanisms behind~     antipsychotic-induced insulin resistance and in particular, the main tissue in which this~     mechanism occurs.~   "
91082|NCT02374983|"~     Gamma Knife Radiosurgery (GKR) is a well established treatment modality for brain tumors and~     functional disorders of the brain. It relies on mathematical algorithms to predict dose~     distribution and to calculate the dose at arbitrary points in the head. For the last 25~     years, doses applied using Gamma Knife Radiosurgery have been calculated using a simple~     algorithm, called the Tissue Maximum Ratio algorithm (TMR). Dose planning using this~     algorithm, relies on a number of approximations to enable fast isodose computation during~     treatment planning. One of the most significant of these is the approximation of the head to~     water-equivalent density. The increased electron density of brain and bone (relative to~     water) and the near-zero density of air cavities in the skull may make significant~     perturbations to isodose and beam-on time calculations.~      With the advent of faster workstations, the effect of tissue in-homogeneities can finally be~     calculated in reasonable time during the treatment planning process; a newer, more modern~     algorithm known as convolution algorithm is now commercially available. It uses the values of~     density indicated in the CT scan to predict the dose distribution and is expected to more~     accurately calculate radiation dose, although it needs further investigation before clinical~     implementation. Inter- and intra-indication differences between the old and new algorithms~     need to be understood before this method can be confidently employed in a clinical setting.~     It is the aim of this study to understand the dosimetric differences between these dose~     calculation algorithms and to evaluate the implications of using the convolution algorithm~     for GKR. A large number of treatments will be re-planned using the convolution algorithm and~     compared to the TMR plans used to treat the patients. Beam-on-time, which is proportional to~     dose and a number of commonly used metrics for the targets such as coverage, selectivity,~     gradient index, and mean and maximum dose, will be estimated with both algorithms. Subgroup~     analysis will be done to assess whether any factor such as diagnosis, size of the head or~     location of the target could impact on the relative difference between the methods. The~     treatment plans will be compared and the potential implications on treatment planning will be~     elucidated.~   "
91093|NCT02374840|"~     The PREACT Registry aims to see whether data from Pharmacogenomic Testing (PGx) can help~     healthcare providers manage patient medication regimens and assess if the testing has an~     effect on reducing medication side effects, hospitalizations and emergency department visits.~      The way an individual processes a drug is in part determined by their genes, and there is~     known to be genetic variation between humans in the way drugs are metabolized. The study of~     the way genes affect a person's response to drugs is known as Pharmacogenomics.~   "
91094|NCT02374827|"~     To compare the feasibility and surgical outcomes between complete salpingectomy and standard~     postpartum tubal ligation (partial salpingectomy) at the time of cesarean delivery in women~     with undesired future fertility. as a possible ovarian cancer risk-reducing procedure.~   "
91083|NCT02374970|"~     Low back pain is not a diagnosis; it is a symptom describing the presence of pain in the~     lumbar vertebral or paravertebral region without any reference to the structure or cause of~     the process. It is one of the most widespread diseases and one of the most common reasons for~     visits in primary care setting.~      Exercises to improve lumbar stability involving co-contraction of the transversus abdominis~     have proved to be effective in reducing pain and improving function. It has been stated by~     ultrasound images that specific stabilization exercises cause contraction of the deep~     abdominal muscles, but it remains unclear whether training produce thickness muscle~     improvement and if this improvement is related to clinical findings.~      To try to resolve this issue a project of an experimental trial, double-blind (patient and~     evaluator) with two groups randomly assigned is presented. All participants will be recruited~     in an primary care center of the Catalan Health Institut and will sign informed consent. All~     will receive a protocolized treatment with therapeutic exercises and thermotherapy and,~     additionally, those assigned to the intervention group were instructed in performing lumbar~     stability exercises.~      Pain (VAS), function (Roland-Morris Questionnaire) and the thickness of the transversus~     abdominis, internal and external oblique muscles (measured by ultrasound) at baseline, end of~     treatment protocol (12 sessions) and three months after the end of treatment will be~     assessed.~      Results in pain, function, and its correlation with the mean changes in the thickness of~     transversus abdominis will be analyzed.~   "
91084|NCT02374957|"~     Twenty patients will be recruited to CLEAR. Ten will be randomized to the treatment arm~     (Cilostazol) and tenwill be randomized to the control group. Patients randomized to the~     treatment arm will receive Cilostazol for 90 days. The primary purpose of this study is to~     collect quality of life data on patients undergoing peripheral revascularization in order to~     determine the sample size required to adequately power a trial of Cilostazol versus usual~     care without Cilostazol and its effect on quality of life.~   "
91085|NCT02374944|"~     This study is a multicenter prospective randomized control trial comparing hardware retention~     (HR) to removal of hardware (RH).~   "
91086|NCT02374931|"~     This pilot clinical trial studies fluorine (F)-18 16 alpha-fluoroestradiol (18F-FES) positron~     emission tomography (PET)/computed tomography (CT) in imaging patients with desmoid tumors.~     18F-FES binds to estrogen receptors, which are present on desmoid tumors, and gives off~     radiation that may be detected by PET and CT scans. The PET/CT scan forms an image that may~     show where tumor cells with estrogen receptors can be found in the body.~   "
91087|NCT02374918|"~     Mild traumatic brain injuries (mTBI) or concussions are an increasingly prevalent injury in~     the investigators society. Patients with post-concussion syndrome have been shown to have~     deficits on tests of short term memory, divided attention, multi-tasking, information~     processing speed, and reaction time, as well as alteration in mood and emotional functioning.~     Many patients have other vague complaints including fatigue, dizziness, irritability, sleep~     disturbances, and chronic headaches. Furthermore, sleep disruption of one of the most common~     complaints in patients suffering from traumatic brain injuries, with as many as 40 to 65% of~     patients with mTBI complaining of insomnia. Sleep problems in these patients are associated~     with poorer outcome, while resolution of the sleep disturbance is associated with improvement~     in cognitive functioning.~      Despite recent evidence of the correlation between sleep quality and recovery from traumatic~     brain injury, and the well-established role of sleep in neural plasticity and neurogenesis,~     there have been virtually no direct studies of the causal effects of sleep on recovery~     following mTBI. However, it is quite likely that sleep plays a critical role in recovery~     following brain injury.~      A particularly promising non-pharmacologic approach that shows potential in~     improving/modifying abnormalities of the circadian rhythm and sleep-wake schedule is bright~     light therapy. For the proposed investigation, the investigators hypothesize that bright~     light therapy may be helpful in improving the sleep of patients with a recent history of mTBI~     and may also have other mood elevating effects, both of which should promote positive~     treatment outcome in these individuals. Bright light therapy may increase the likelihood that~     they will recover more quickly, benefit more extensively from other forms of therapy, and~     build emotional and cognitive resilience.~      This study will also have a healthy control (HC)/effect localization arm that will assist in~     identifying and mapping the brain systems before and after light exposure so that researchers~     may develop further insights into the relationship between concussion, light exposure, sleep,~     and brain function. This healthy control arm will also provide brain targets for study in the~     analysis of the Main Study Arm.~   "
91088|NCT02374905|"~     The investigators wish to investigate the feasibility of using a web based drinking app~     (www.drinksmeter.com) to reduce alcohol consumption among patients attending an outpatient~     clinic in a dental setting.~   "
91089|NCT02374892|"~     The CHAPTER III Study (Congenital Heart Adolescents Participating in Transition Evaluation~     Research) is a cluster randomized controlled trial evaluating the impact of a nurse-led~     transition intervention in combination with usual care, versus usual care alone, on preparing~     adolescents with congenital heart disease (CHD) to successfully transition from pediatric to~     adult cardiology care. The Canadian Pediatric Society and American Academy of Pediatrics have~     recommended that transition interventions begin in early adolescence. Therefore, the~     investigators propose to conduct a nurse-led intervention that addresses the educational~     needs of 13-14 year olds.~   "
91090|NCT02374879|"~     This is an open-label, non-randomised pilot study, to evaluate user performance and system~     accuracy in blood Glucose monitoring system with glucose adjustment. Twelve male and female~     volunteers aged 18-45, with a documented diagnosis of Type I diabetes for at least 12 will be~     enrolled in this study.~   "
91091|NCT02374866|"~     The literature data show that long-term monitoring has an effect on weight loss, comorbidity~     and on improving the quality of life. However, there are still no studies on monitoring obese~     patients after taking initial multidisciplinary approach. The recommendations of the HAS 2011~     advocated continuous monitoring needed to prevent weight regain, monitor the consequences of~     overweight and treat comorbidities. This requires a long-term support. The frequency of~     follow-up consultations is not specified and must be adapted to achieve a weight loss target~     and maintain. Having no specific recommendations on the frequency of monitoring, the~     investigators chose to experiment closer monitoring than our current monitoring to assess~     what is the best frequency monitoring, in terms of: weight loss, quality of life, feeding~     behavior, changes in physical abilities, evolution of comorbidities associated with obesity.~     The recommendations of the HAS 2011 advocate support of a multidisciplinary obesity for~     weight loss of 5% to 10 %, which, if maintained, can reduce comorbidities associated with~     obesity (type 2 diabetes, hypertension, pain associated with osteoarthritis).~   "
91092|NCT02374853|"~     The purpose of this research is to determine if using the antibiotic vancomycin as a~     preventative topical (on the surface of the skin) treatment during open-heart surgery will~     reduce the risk of developing a sternal wound infection.~   "
91095|NCT02374814|"~     The purpose of this study is to compare the effectiveness of a two dose versus a three dose~     schedule and intramuscular versus intradermal injection for pre-exposure prophylaxis.~   "
91096|NCT02374801|"~     The objective of the Continued Access study is to gather confirmatory evidence on the safety~     of the SonRtip lead and performance of the automatic atrioventricular (AV) delay and~     interventricular (VV) delay optimization algorithm used in the PARADYM RF SONR Cardiac~     Resynchronization Therapy with Defibrillation (CRT-D) device (Model 9770) in a patient~     population that is reflective of current heart failure treatment practice.~   "
91097|NCT02374788|"~     The aim of the study is to investigate the effects of two levels of primary care physical~     activity interventions on metabolic control and cardiovascular risk factors, compared to~     usual care in patients with pre- and type 2 diabetes.~      The hypothesis is that both levels of interventions have effect on HbA1c with the more~     intense Group intervention having superior effects.~   "
91098|NCT02374775|"~     The EMERALD trial is a multinational, multicenter study. The patients presented with~     AMI/definite evidence of plaque rupture and had underwent coronary CT angiography from 1~     month to 2 year prior to the event will be retrospectively searched. Plaques in the~     non-culprit vessels will be regarded as internal control to the ruptured plaque in the~     culprit vessel.~   "
91099|NCT02374762|"~     The goal of this study is to find the best techniques to take non-invasive images of the~     arteriovenous fistula (AVF) in hemodialysis patients.~   "
91100|NCT02374749|"~     Giving both the gap existing between the current recommendations to prevent/detect~     comorbidities and the clinical practice in patients suffering from spondyloarthritis and also~     the specificity of some recommendations to rheumatic diseases, it seems logical to check~     these recommendations in a rheumatologic environment.~      This study with its two parts should be able to demonstrate:~        -  The importance of a systematic evaluation of comorbidities in Spondyloarthritis,~        -  The utility of a nurse-led program of self-assessment and self-management of the disease~   "
91101|NCT02374736|"~     The principal objective of this pilot study is to determine whether the progression of~     chronic antibody-mediated rejection (ABMR) could be minimized by the post-transplant~     administration of high dose of Intravenous Immunoglobulins (IVIg).~      We test the hypothesis that repetitive IVIg administration reduces or stabilize the~     progressive loss of transplant function and the evolution to chronic ABMR in stable kidney~     transplant patients with HLA-DSA developed post-transplantion (de novo HLA-DSA) and~     concomitant humoral graft injury.~   "
91102|NCT02374723|"~     Constructs made from cross-linked Human Recombinant Collagen type III are being used instead~     of human donor corneas in 6 patients at Deep anterior lamellar cornea grafting. Six patients~     serve as controls and are receiving human donor corneas using the same surgical technique.~     The twelve patients will be recruited from the local waiting list for patients to be~     undergoing corneal grafting. If the patients meet the inclusion criteria and agree to~     participate following oral and written consent, they will be randomized to either group. The~     patients will be followed for 12 months and documented with OCT, In Vivo Confocal Microscopy,~     slit lamp photography a o. The study is planned as a safety study with initial efficacy~     documentation.~   "
91103|NCT02374710|"~     Although extensive research has been carried out on Anterior Cruciate Ligament (ACL) femoral~     tunnel placement, very little attention has been given to the tibial tunnel. Researchers have~     suggested that the tibial tunnel be placed in the center of the ACL footprint, which they~     described as being approximately 43% of the way (anterior-to-posterior) across the proximal~     tibia at its widest extent. However, others have suggested that a more anterior placement may~     yield improved biomechanical and clinical results. The center of the ACL footprint and the~     posterior aspect of the anterior horn of the lateral meniscus does not yield tibial tunnel~     placement a consistent percentage of the way across the tibial plateau; therefore, guidelines~     should be based on intraoperative fluoroscopic measurements. However, the question remaining~     is what percentage of the anterior-to-posterior distance across the tibia is the ideal~     location for the tibial tunnel in ACL reconstruction. This study will help answer that~     question.~      Patients with a diagnosed rupture of the ACL who are scheduled for surgical reconstruction~     will be considered for enrollment. Eligible patients will be allocated to one of two groups~     based on the location of the tibial tunnel (anterior vs. posterior) during the surgical~     procedure. In addition to a baseline (pre-operative) evaluation, participants will return for~     follow-up visits at 6, 12, and 24 months post-surgery. Follow up will be completed at 24~     months.~      The primary objective of this study is to collect subjective and objective measures of~     knee-related function in patients with an anterior vs. posterior placed tibial tunnel through~     24 months postoperative care.~   "
91104|NCT02374697|"~     The purpose of this study is to determine whether digitalizing pathological slides and let it~     accessible on a server for a second medical opinion (tele-expertise) would reduce the time to~     diagnosis.~   "
91105|NCT02374684|"~     The purpose of this study is to determine the safety and tolerability, and to evaluate the~     pharmacokinetic characteristics and food effect of Methosulide after oral administration in~     healthy adult subjects.~   "
91106|NCT02374671|"~     The purpose of this study is to evaluate the safety and effectiveness of the VisAbility Micro~     Insert System for the improvement of near visual acuity in presbyopic patients.~   "
91107|NCT02374658|"~     The ARTS-REHAB Project Research Study examines how meaningful engagement in a creative~     process might impact inpatients in rehabilitation centres. Participants in this random~     control trial study will be recruited from a slow-stream rehabilitation patient population.~     The study intervention will consist of The Royal Conservatory's Living Through the Arts~     program. Data will be collected using structured and semi-structured questionnaires along~     with observational logs and focus groups. This study will explore the effects of the program,~     comparing the intervention and control group participants' sense of hope and optimism for~     returning to their daily lives, as well as their sense of engagement in their physical~     recovery.~   "
91108|NCT02374645|"~     This is a Phase 1b, open-label, multicentre study of AZD6094 in combination with gefitinib in~     patients with epidermal growth factor receptor (EGFR) mutation positive (m+) and progressed~     on EGFR Tyrosine kinase inhibitor (TKI) treatment.~   "
91124|NCT02374437|"~     This is a single-site, randomized, partly double-blind, placebo-controlled study of Aramchol~     in sixty six (66) healthy male volunteers.~      In each part of the study subjects will be enrolled in the study within 28 days before drug~     administration(s).~      The study will consist of three parts and the subjects will be assigned to three Parts.~   "
91109|NCT02374632|"~     After gastric bypass, 10-20% of patients will obtain a suboptimal weight loss, often defined~     as <50% of the excess body weight. Exaggerated meal related secretion of gut hormones seem~     important for appetite reduction and subsequent weight loss after gastric bypass, however it~     is not clear whether different gut hormone responses are responsible for different~     postoperative weight loss responses. The purpose of the study is to investigate gut hormone~     secretion, vagal integrity and the effect of octreotide on ad libitum food intake in patients~     with suboptimal weight loss after gastric bypass and compare results to a matched group of~     gastric bypass operated patients with high postoperative weight loss but similar age, sex and~     preoperative BMI.~   "
91110|NCT02374619|"~     Iron supplementation is very common in athletes, probably due to its catalytic role on the~     oxygen transport and optimal function of oxidative enzymes and proteins during exercise.~      Iron is also characterized as a potent pro-oxidant, as it can lead to increased production of~     reactive oxygen and nitrogen species (RONS) that are involved in critical biological~     processes, such as gene expression, signal transduction and enzyme activity. In exercise, low~     levels of RONS are essential for optimal force production, whereas excessive production of~     RONS can cause contractile dysfunction, resulting in muscle weakness and fatigue. On the~     other hand, RONS are involved in signaling pathways and up-regulation of the expression of~     several genes, and therefore, RONS can provoke favorable effects such as training~     adaptations.~      The purpose of the present study is to investigate the effect of iron supplementation on~     redox status, muscle damage and muscle performance after an acute bout of a valid muscle~     damaging eccentric exercise model in adults and children.~   "
91111|NCT02374606|"~     A strength measurement device called Accurate Test of Limb Isometric Strength (ATLIS) was~     developed to precisely and conveniently measure static limb strength in patients with ALS.~     The investigator will compare ATLIS data with data from the commonly used ALS outcomes~     measure, the ALS Functional Rating Scale-Revised (ALSFRS-R), as well as an exploratory~     measure, electrical impedance myography (EIM), in a prospective, longitudinal study. Both~     outcomes measures will be performed on 100 subjects collected preferably at bi-monthly clinic~     visits during the study period.~   "
91112|NCT02374593|"~     This is a clinical study comparing targeted levothyroxine dosing based on thyroid anatomy as~     visualized on ultrasound (normal vs. ectopic/sublingual vs. athyreosis) to empiric~     levothyroxine dosing in infants with congenital hypothyroidism. Patients enrolled in the~     study for targeted dosing will be compared to controls obtained by retrospective chart~     review. The main outcome is to determine if there is a difference in the frequency of~     over-treatment and under-treatment during the first 6 months of therapy.~   "
91113|NCT02374580|"~     For more than a decade, Uganda's Ministry of Health has led a community health worker program~     model in which Village Health Teams (VHTs), cadres of unpaid volunteers, are assigned the~     task of delivering preventative health services and education to their local communities.~     Studies have demonstrated the effectiveness of Uganda's VHTs in improving certain health~     outcomes; however it is known that VHTs are not optimally supported, and there has been VHT~     attrition in recent years. The Ministry of Health has recognized the inadequate support of~     VHTs thus far and is aiming to expand VHTs to all local governments and explore ways of~     sustaining VHTs. The objective of this study is to evaluate the extent to which material~     support is a deciding factor in the efficiency and durability of Uganda's VHT initiative.~     Material support may take the form of monetary stipends, regular payment, transportation~     assistance, or nonfinancial materials such as bicycles or mobile phone airtime. This study~     will review existing literature and gather novel data through surveys of VHT members and VHT~     stakeholders. The quantitative and qualitative survey data will be analyzed for trends that~     may point to a conclusion in the context of existing health policy discourse on community~     health worker remuneration. The purpose of this study is to strengthen the knowledge base on~     whether or not the current absence of material support significantly limits the potential for~     Uganda's VHTs to be sustained and expanded. This information can be used by governmental and~     non-governmental organizations in their work to strengthen and sustain VHTs throughout the~     country.~   "
91114|NCT02374567|"~     The purpose of this multicenter-study is to investigate safety of psychopharmacological~     treatment and rates of adverse drug reactions in gerontopsychiatric inpatients. Elderly~     people are at higher risk for developing side effects under pharmacological treatment due to~     an altered metabolic situation, higher comorbidity rates and often polypharmacy. Furthermore~     gerontopsychiatric patients can often not articulate their symptoms clearly, for example due~     to pronounced cognitive impairment.~      The aim of the study is to gain valid data of possible adverse drug reaction rates, their~     potential risk factors and outcome, as well as medical prescription practises.~      To assess these outcomes an intensive pharmacovigilance-monitoring will be conducted at the~     five participating study sites.~      At Baseline demographic data, previous and present disorders, use of drugs, previous and~     present medication, quality of life, cognitive function, physical examination results,~     laboratory results and ECG will be assessed.~      Afterwards patients are visited weekly and screened for possible adverse drug reactions. All~     adverse drug reactions will be coded in the MedDRA-system.~      In case of a possible serious adverse drug reaction serum levels of all psychotropic~     substances applicated will be assessed. Drug combinations will be analysed using an~     established advanced bioinformatic tool (mediQ). Diagnosis, medication intake and possible~     adverse drug reactions are documented continually.~      2 weeks after discharge from the ward, patients will be contacted by phone to assess~     catamnestic data.~   "
91125|NCT02374424|"~     Aim of this trial is to assess the efficacy of new anti-CD20 antibody (GA101) in association~     with DHAP as induction therapy before high dose chemotherapy BEAM with ASCT in patients with~     relapsed/refractory DLBCL.~   "
91126|NCT02374411|"~     The goal of this survey of international HIPEC (Hyperthermic Intraperitoneal Chemotherapy)~     surgeons is to determine their knowledge of and attitudes towards the nutritional support~     needs of HIPEC patients and what their practice patterns are with this patient population.~   "
91127|NCT02374398|"~     The aim of the study is to determine if the use of iv TXA or Aquamantys system improve the~     postoperative hemoglobin and hematocrit after primary TKA and what is the effect of the~     simultaneous use of iv TXA and Aquamantys on the postoperative hemoglobin and hematocrit. The~     assumption is that the combination of iv TXA and Aquamantys system will enable an improvement~     in the postoperative hemoglobin and hematocrit equal or larger than the improvement generated~     by the use of Aquamantys system alone.~   "
91115|NCT02374554|"~     Respiratory rate (RR) is a vital sign used to monitor clinical condition of a patient.~     Various devices using different techniques are available to measure RR. One technique,~     capnography, uses continuous monitoring of expired gases, via a nasal cannula to assess end~     tidal CO2 concentration. This long-established technique is frequently used for patients in~     intensive care. Both RR and the shape of the capnogram waveform, which has a wave pattern~     marked by alternating inspiratory and expiratory phases, are used to help monitor the~     patient. Clinician Over-scored End Tidal C02 (COSC) waveform (whereby an expert identifies~     and scores each breath on the waveform and counts the number of breaths per minute) is~     considered to be a gold standard for measuring RR.~      Being able to record RR, without contact or interference with the patient is appealing~     because it requires minimal patient co-operation, enables measurements even during acute~     respiratory conditions, and may be more representative of real life physiology. Based on a~     principle originally described in the 1980s, a novel instrument that uses a completely~     non-contact system based on structured light plethysmography (SLP) has recently been designed~     by Cambridge University Hospitals Foundation Trust. The device has been refined with the~     development of the Thora-3Di by Pneumacare Ltd, Cambridge. A grid of visible light is~     projected onto the thoraco-abdominal wall and two digital video cameras record changes in the~     grid pattern due to breathing motion. A waveform is produced by the anterior excursion of the~     thoraco-abdominal wall (SLPVol) over time, and a numerical output of RR is provided . The~     present study aims to simultaneously measure tidal breathing with the Thora-3Di and a BCI~     Capnograph 9004 device to compare the Thora-3Di RR output against that of the gold standard~     clinician over-scored end-tidal C02 (COSC) and to assess equivalence of the two devices with~     the aim to establishing the validity of SLP for RR measurement.~   "
91116|NCT02374541|"~     The SaLSA (Screening and Linkage to Services for Autism) study will test whether patient~     navigation can help disadvantaged families obtain earlier diagnosis and treatment for their~     children who have had a positive screening test for autism spectrum disorder. Half of the~     families will be offered help from an autism patient navigator. The other half will receive~     standard care.~   "
91117|NCT02374528|"~     The repairing of various wounds is always a great challenge in burn surgery and plastic~     surgery. Skin-grafting is the main therapy. Bolster dressings are traditionally applied to~     secure the graft to the wound bed, however, there is some evidence to show that irregularly~     contoured recipient sites, poorly healing areas, reduce the success rate of skin-grafting~     with traditional bolster dressings, increasing morbidity, pain. Negative pressure wound~     therapy has been advocated as a potential solution to some of these issues. To further test~     the healing rate and safety of this new method, the investigators propose a prospective~     randomized controlled trial to compare this method with traditional bolster dressings~     application in skin-grafting.~   "
91118|NCT02374515|"~     This study investigated the impact of Endocuff-assisted colonoscopy on the adenoma detection~     rate at colonoscopy. This study involved patients undergoing elective screening or~     surveillance colonoscopy.~      Patients were randomized to undergo Endocuff or regular, high-definition colonoscopy before~     undergoing a second colonoscopy by the alternate method. The primary outcome measure was the~     detection rate for adenomas between patients who underwent Endocuff first and patients who~     underwent regular colonoscopy first.~   "
91119|NCT02374502|"~     Ankylosing spondylitis is a chronic inflammatory condition that mostly affects the spine.~     This results in back pain and stiffness, and causes difficulty with daily activities.~     Physical activity and exercise are key components of the management of ankylosing~     spondylitis, however many adults with ankylosing spondylitis do not meet physical activity~     recommendations. This study aims to investigate the effects of a twelve week intervention~     designed to increase physical activity and exercise in adults with ankylosing spondylitis.~   "
91120|NCT02374489|"~     Primary objective:~      To investigate the objective response rate in patients with ROS1 or ALK over-expressed~     locally advanced, or metastatic intrahepatic or hilar cholangiocarcinoma receiving LDK378~     Secondary objectives:The progression-free survival ,The disease control rate ,The overall~     survival ,The toxicity profiles , The correlation between clinical outcomes and the potential~     predictive biomarker for tumor response~   "
91121|NCT02374476|"~     This non-randomized study will examine the safety and efficacy of irrigated bipolar~     radiofrequency (RF) ablation in the treatment of ventricular tachycardia (VT) in patients for~     whom standard VT unipolar RF ablation has been unsuccessful. VT is a serious abnormality of~     the heart's electrical system. Ablation is a procedure that cauterizes heart tissue using~     catheters (long tubes that can be moved within or along the outside of the heart).~     Cauterizing the heart tissue is accomplished by using heat to damage the abnormal heart~     tissue that is not working well so that it can stop affecting the rest of the heart. Usually,~     heat is delivered using a unipolar catheter, in which energy travels from the catheter tip to~     a grounding pad. This research study seeks to find out if a bipolar ablation catheter, in~     which the energy travels between two catheter tips on either side of the heart muscle, can be~     used to eliminate the arrhythmia when the unipolar ablation is unsuccessful. The hypothesis~     is that the increased current density and improved rates of transmural lesion creation seen~     with bipolar RF ablation will lead to successful arrhythmia termination with minimal or no~     increased risk of complication.~   "
91122|NCT02374463|"~     Falls are dangerous leading to injuries and even death. The VA has made fall prevention a~     priority, but effective programs only reduce falls by 30%. Tai Chi, a standing exercise~     program, has been effective at improving balance but may not prevent falls. Most falls occur~     during walking when an individual experiences a slip or a trip. Programs that focus on~     walking, stepping, and recovery from a slip may be more effective at fall reduction. This~     study will compare Tai Chi to a novel multimodal balance intervention (MMBI). MMBI focuses on~     standing balance, walking, stepping, strength training, and recovery from a slip. The~     Investigators believe that the MMBI program will be more effective than Tai Chi at improving~     balance and preventing falls in older Veterans and the Investigators will use the results of~     this study to develop a larger study on fall prevention in older Veterans.~   "
91123|NCT02374450|"~     The purpose of this pre-licensure cohort study is to estimate the incidence of adverse events~     of special interest (AESI), other adverse events (AE) leading to hospitalisation or death,~     meningitis and malaria in sub-Saharan African children under 5 years of age. The outcomes of~     this study will provide the baseline data for the post-licensure EPI-MALARIA-003 (115056)~     study that will evaluate the safety, effectiveness and impact of the RTS,S/AS01E vaccine.~      An interim analysis will be performed when the RTS,S/AS01E vaccine will be implemented in~     most of the study sites. This interim analysis will be done with clean data collected on a~     sub-group of subjects having 6 months of follow-up following the administration of dose 3 of~     DTP/HepB/Hib vaccine (6 12 weeks group), or 6 months after Visit 3 (5-17 months group);~     corresponding to Visit 5. The interim analysis will concern primary safety endpoints and the~     main impact endpoints (at 6 months post last dose for the purpose of this interim).~   "
91128|NCT02374385|"~     Background:~      Ebola virus has infected and killed people, mostly in Africa. In 2014, the Ebola virus has~     affected several thousand people. There is no approved effective way to treat or prevent~     Ebola. Researchers are trying to develop a vaccine for it.~      Objectives:~      To study the anti-Ebola vaccine VSV ZEBOV (BPSC1001) to see if it is safe. Also, to see how~     it affects people's immune system.~      Eligibility:~      - Healthy men and women ages 18-65. They must not have a chronic medical condition that~     requires medicine. They must not be a healthcare worker, an animal care worker, or a~     childcare worker, and they must not have a household contact that has a compromised immune~     system, is pregnant, or is under the age of 5 years.~      Design:~        -  Participants will be screened with medical history, physical exam, and blood tests.~        -  Participants will be randomly assigned to get the vaccine or the placebo.~        -  At visit 1 (vaccination), vital signs will be taken and blood will be drawn. The vaccine~          or placebo will be injected into the upper arm muscle.~        -  Participants will return to the clinic 11 times over the next 6 months. Participants~          will have blood drawn at every study visit. Their mouth will be swabbed and urine tested~          at least four times after vaccination.~        -  For 14 days after vaccination, participants will write down their temperature, any~          symptoms, and any redness at the injection site. They will bring the booklet to each~          study visit.~      All visits take place at the Canadian Center for Vaccinology, Dalhousie University/IWK Health~     Centre, Halifax, NS.~   "
91129|NCT02374372|"~     The site where the clinical trial will be conducted is at the St-Luc hospital from the CHUM.~     This is a prospective randomized study that will compare the two treatment modalities, HD and~     HDF, through economics and pharmaco-economics parameters.~      Patients, who had previously been randomized in the CONTRAST study, will remain in their~     respective group and monitoring will continue. The next patients will be randomized in the~     same way (1: 1) using the same inclusion and exclusion criteria. HDF randomized patients will~     receive post-dilution standard reinjection (at least 100ml/min or 6 liter/hr). In rare cases,~     HDF patients can briefly have reinjection on a pre-dilution mode (if heparin need to be~     avoided for example) and the reinjection flow should be adjusted accordingly (200ml/min).~      Length and frequency of sessions will be the same in the 2 groups. Blood tests will not~     change and will be the same than those used as routine assessments. Metabolic control of~     patients will be maintained according to the guidelines. Patients will be monitored for a~     minimum of 3 years. A set of demographic and clinical data will be collected from patient~     medical records and throughout the study.~      Biochemical data as part of the usual blood tests of dialysis patients will be collected each~     month as well as will be stored and analyzed information about the annual cardiac~     ultrasounds.~      All events will be scored (hospitalizations, patterns, duration) and the list and cost of~     drugs will be compiled every three months. These data will be useful in the economic analysis~     comparing the two treatment modalities.~   "
91130|NCT02374359|"~     There is few information about the association between supraventricular arrhythmia different~     from atrial fibrillation (AF) or atrial Flutter and the risk of stroke. In this study the~     investigators hypothesized that the presence of atrial tachycardia would lead to atrial~     fibrillation and recurrent stroke in patients hospitalized for cryptogenic stroke.~      The investigators study the association of atrial tachycardia (AT), defined as four or more~     consecutive premature atrial beats, and AF, recurrent stroke and cardiovascular mortality in~     192 consecutive patients hospitalized because of cryptogenic stroke. The follow-up was 12~     months for all population~   "
91131|NCT02374346|"~     To evaluate the association of anaesthesia and surgery with postoperative headache in~     elective surgery patients By multiple logistic regression analysis of data collected during a~     six-month period from 446 patients undergoing elective surgery, a prospective single centre~     cohort study in a university hospital. Participants were interviewed preoperatively and for~     five days postoperatively regarding the appearance of headache; while demographics, life~     style, type of anaesthesia and surgery, the anaesthetic drugs administered and intraoperative~     adverse effects in elective surgery patients are recorded.~   "
91132|NCT02374333|"~     This is a pilot study to evaluate humanized CD19 redirected autologous T cells (or huCART19~     cells) in patients with relapsed or refractory CD19+ leukemia and lymphoma that was~     previously treated with cell therapy. This study is targeting pediatric patients aged 1-24~     years with CD19+ B cell malignancies with no available curative treatment options (such as~     autologous or allogeneic stem cell transplantation) who have a limited prognosis with~     currently available therapies and were previously treated with a B cell directed engineered~     cell therapy product.~   "
91133|NCT02374320|"~     The purpose of this study is to investigate whether the use of the study drug (Exparel) is~     safe and effective for treating circulation problems and pain in the hand or fingers.~   "
91134|NCT02374307|"~     The aim of this study is to investigate the effect of a falls-prevention program on quality~     of life, fear of falling, falls and physical function in older people receiving home-help~     services. The participants in the intervention group will perform the Otago exercise~     programme. The participants in the control group continue with their usual activities.~   "
91135|NCT02374294|"~     In colorectal surgery, oxygen insufflation (which leads to higher oxygen concentration in the~     surgical site) has been shown to decrease infection rate. Several pressure wounds in the~     coccyx have been successfully treated to closure with Transdermal Continuous Oxygen Therapy~     (TCOT) Given the wound healing properties of TCOT, particularly in infection-prone anatomic~     locations such as coccyx, and the microbicidal properties of oxygen, it is expected that the~     infection rate in abdominoperineal (AP) resection surgery can be reduced with transdermal~     continuous oxygen therapy. The primary objective of this study is to compare the number of~     surgical site infections associated with perineal surgery within 28 days between subjects~     randomized to receive EPIFLO or Standard of Care~   "
91169|NCT02373852|"~     The objective of this study is to collect data on the use of the WIRION system in Patients~     undergoing Percutaneous Intervention of Saphenous Vein Graft (SVG).~   "
91331|NCT02371733|"~     Decreased exercise capacity, peripheral muscle strength and quality of life and increased~     dyspnea and fatigue perception is prevalent in patients with pulmonary arterial hypertension.~     It was demonstrated exercise training has beneficial effects in patients with pulmonary~     arterial hypertension. However, no study investigated the effects of upper extremity aerobic~     exercise training, therefore effects of upper extremity aerobic exercise training on outcomes~     in patients with pulmonary arterial hypertension.~   "
91136|NCT02374281|"~     The management of the pain is a constant care concern in neonatal and maternity units. Many~     studies show an interest in the use of sugar solutions to reduce nociception during painful~     events in infants. However, these studies are based mainly on behavioral observation of the~     newborn but intrinsic mechanisms of analgesic power are not clearly understood for sucrose~     solutions.~      Our hypothesis is that the analgesic mechanism of sucrose solutions in infants involves a~     subcortical reactivity notably by action via the brain stem. To explore the intensity of pain~     and evaluate the subcortical activity, we will use 1) the analysis of heart rate variability~     (frequency indices whose HFnu) as a peripheral witness of subcortical functioning of the~     autonomic nervous system 2) electroacoustic analysis of the intensity of crying baby, 3) a~     composite pain score (DAN score).~   "
91137|NCT02374268|"~     Sarcopenia represents the loss of skeletal muscle and strength that occurs with aging. It is~     a major component of frailty and its effect on daily functioning, falls, and fractures has~     been well documented. Along with the population aging worldwide, the number of people with~     sarcopenia is expected to increase and, thus, contributing to dependency and the anticipated~     increase in health and social care costs. The cause of sarcopenia is multifactorial. Recent~     evidence suggests that some reversibility exists, highlighting the importance of intervention~     modalities. However, the role of nutritional supplementation and exercise programs, either~     individually or in combination, is still uncertain, and further randomized controlled trials~     (RCTs) have been recommended by the International Sarcopenia Initiative. Therefore, the~     investigators plan to conduct a 24-month RCT to compare the effectiveness of 12-week exercise~     program alone, combined exercise program and nutrition supplement, and non-exercise control~     group on improving muscle mass, strength and power and physical performance in Chinese older~     people who have sarcopenia defined using the Asian Working Group Criteria (AWGC). The~     investigators hypothesize that compared with the non-exercise control group, there will be~     improvement in muscle strength, power and mass, and physical performance in the exercise~     alone group, and that there will be an additive effect with the combined exercise and~     nutrition supplement group. Chinese older people aged 65 years and over will be recruited for~     a brief screening of sarcopenia and cognitive status. Potential subjects will further~     undertake detailed body composition and biochemical measurements to check for their~     eligibility. Eligible subjects will be randomized to one of the three groups: exercise~     program alone, combined exercise program and nutrition supplement, or waitlist control group~     with the same exercise program offered after 24-week of study enrollment. Each group will~     have 45 subjects. Outcome measurements including muscle strength, power and mass, physical~     performance, instrumental activities of daily living and related biochemical measurements~     will be made at baseline, 12 and 24 weeks.~   "
91138|NCT02374255|"~     The goal of this study is to increase and improve Goals of Care discussions for advanced~     cancer patients by training medical oncologists to conduct these discussions. The~     investigators will evaluate the GoC discussion's effects on patient satisfaction, receipt of~     treatment in line with preferences, use of aggressive treatment, and oncologist communication~     skill.~   "
91139|NCT02374242|"~     The purpose of this research project is to test the effectiveness of nivolumab versus~     nivolumab together with ipilimumab for the treatment of melanoma brain metastases.~      Patients are eligible to join this study if they are aged 18 years or above and have been~     diagnosed with melanoma with brain metastases.~   "
91140|NCT02374229|"~     The aim of this prospective randomized study was to evaluate the effectiveness and safety of~     the original ablation procedures ganglion plexus pulmonary artery with simultaneous~     correction of valvular heart disease, complicated by high pulmonary hypertension.~   "
91141|NCT02374216|"~     The purpose of this prospective clinical trial is to investigate and identify factors~     associated with the failure of dental implants within the population rehabilitated with~     dental implants at the Folktandvården Specialistklinik in Malmö (Spårvägsgatan 12, 214 27,~     Malmö).~   "
91142|NCT02374203|"~     The investigators first aim is to compare the EE and BEE in critically ill patients in~     Taiwan. The second aim of this study is to examine protein requirements in different age~     groups in critically ill patients, and their relationship to factors causing inadequate~     enteral nutrition, duration of mechanical ventilation, newly diagnosed infection and duration~     of intensive care unit (ICU) stay.~   "
91143|NCT02374190|"~     Globally, there is increasing focus on optimization of health system quality. International~     austerity, concerns regarding health care safety and effectiveness, and underlying~     aspirations to continually improve patient experience and outcomes are among the factors~     driving interest in measuring, rewarding, and optimizing quality of care. Care for~     cardiovascular diseases is of particular importance as a leading cause of premature death in~     the UK and across the world. With this as a backdrop, recent studies reveal the persistence~     of significant variations in risk‐adjusted health outcomes across English AMI populations,~     suggesting widespread application of ineffective care. In spite of this evidence, little is~     known on the extent to which modifiable, care‐related factors explain observed variations in~     risk‐adjusted AMI mortality rates. Set in this context, a recent conceptual model -~     emphasizing the influence of in‐hospital care on health outcomes - offers a new opportunity~     to 1) re‐examine the quality of acute treatment for AMI, and 2) reveal the extent to which~     care delivery influences and explains variations in mortality following acute admission. This~     study seeks to use data from the Myocardial Ischaemia National Audit Project (MINAP) within a~     retrospective, observational paradigm to examine the relationship between primary care,~     pre‐hospital patient status, acute clinical management and patient outcomes. Findings are~     expected to give a new perspective to quality of integrated AMI care in England.~   "
91144|NCT02374177|"~     The purpose of this study is to prove the correlation between the post-operative delirium~     (POD) and anesthetic agents. The investigators hypothesized that intravenous anaesthetics~     would show the lower incidence of POD, compared with inhalation anaesthetics in off-pump~     CABG.~   "
91145|NCT02374164|"~     The purpose of this study is to assess the effect of food on the bioavailability of~     febuxostat after a single oral dose of 80 mg febuxostat XR and to evaluate the~     pharmacokinetics (PK) of febuxostat after single oral doses of 40 and 80 mg febuxostat XR.~   "
91146|NCT02374151|"~     This is a case control prospective study aiming to investigate the accuracy of the~     electrohysterography (EHG) compared to the intrauterine pressure catheter ( IUPC) that is~     commonly used in delivery room. Women in second phase of labor - indicated for insertion of~     IUPC will be asked to participate . Patients that will give their informed consent will be~     connected both to IUPC and EHG. Medical history and demographic parameters will be taken. The~     graphs will be compared and analyzed for its frequency and intensity. Delivery mode and fetal~     well-being will be recorded~   "
91332|NCT02371720|"~     The purpose of this research study is to learn about ways to help children and adults with~     sickle cell disease who are taking the medication, hydroxyurea.~   "
91333|NCT02371707|"~     This study aims to establish bioequivalence between two tablet formulations of idalopirdine~   "
91147|NCT02374138|"~     Uncontrolled asthma in at-risk youth responds well to guideline-based therapy when patients~     remain adherent to their management plans. Adherence to inhaled corticosteroids (ICS), when~     indicated for persistent or uncontrolled asthma, is a critical component of most asthma~     management plans, and other self-management practices such as trigger avoidance are similarly~     related to improved asthma outcomes. Adherence to self-management practices is mediated by~     multiple factors, including psychosocial stress of parents and their children.~      A targeted, culturally appropriate intervention to manage psychosocial stress among the~     parents of young, African American, and socioeconomically disadvantaged urban children with~     asthma who are receiving guideline-based care may improve asthma self-management, and~     therefore asthma outcomes.~      Our overall aim is to implement and evaluate a highly collaborative, multi-dimensional,~     culturally appropriate and community-based asthma intervention to augment existing~     guideline-based best practice. The intervention will target the parents of at-risk, urban,~     African American youth, and will employ individualized psychosocial stress management and~     peer support.~   "
91148|NCT02374125|"~     There is not a clear understanding of the origin of symptoms perceived by patients with~     impingement of the soft tissue structures of the subacromial space. Tendinopathy, tendon~     rupture or other pathologies, are present in asymptomatic subjects and subjects with symptoms~     and structural integrity can also be found.~      Patients diagnosed with subacromial impingement syndrome frequently have myofascial trigger~     points in the teres major muscle. Travell and Simons reported that the symptoms caused by~     trigger points in this muscle are similar to those experienced by patients diagnosed with~     impingement syndrome, but a literature search provides few results regarding relationship~     between subacromial impingement syndrome and presence of myofascial trigger points in the~     teres major muscle.~      This study aims to provide evidence of the results that can be obtained with a specific~     approach of teres mayor muscle by two manual techniques, Trigger Point Pressure Release and~     Diacutaneous Fibrolysis, in subjects with subacromial impingement syndrome, a condition that~     still representing both a diagnostic and therapeutic challenge. Secondary objective is to~     compare the outcomes between both techniques to select for each patient the most appropriate~     to their needs and characteristics.~   "
91149|NCT02374112|"~     This study evaluates the effectiveness of medium-term supplementation with creatine to~     improve clinical outcomes in well-defined adult CFS population. Half of the participants will~     receive creatine while the other half will receive placebo.~   "
91150|NCT02374099|"~     The purpose of this study to Assess the Efficacy and Safety of the Epigenetic Modifying~     Effects of CC-486 (Oral Azacitidine) in Combination With Fulvestrant in Postmenopausal Women~     with ER+, HER2- Metastatic Breast Cancer Who Have Progressed on an Aromatase Inhibitor.~   "
91151|NCT02374086|"~     Angina in the absence of obstructive coronary artery disease is highly prevalent in women,~     and leads to increased risk for major cardiovascular events, including myocardial infarction,~     stroke, and heart failure. Annual mortality rates are ten-fold higher than mortality from~     breast cancer, and the lifetime cost of health care for women with non-obstructive chest pain~     is close to $1 million. Coronary microvascular dysfunction is a major etiological feature of~     this disease, and may contribute to disease progression. Despite our general understanding,~     effective treatment remains elusive. This pilot study will test whether regular exercise~     training can improve/reverse coronary microvascular dysfunction in women with angina but no~     obstructive coronary artery disease.~   "
91152|NCT02374073|"~     Purpose: Subacromial impingement syndrome is the most common shoulder condition. Myofascial~     trigger points in teres major muscle can be associated with this syndrome. The investigators~     objective is to find out if adding manual therapy specifically for teres major trigger points~     can produce better results in these patients.~      Method: A randomized controlled pilot study was carried out. Fifty people were randomly~     assigned to one of two groups: intervention group or control group. Both groups received a~     protocolized physical therapy treatment while the intervention group additionally received~     manual therapy for teres major trigger points.~   "
91153|NCT02374060|"~     To evaluate the relative efficacy of three commonly utilized regional corticosteroids for the~     regional treatment of uveitic macular edema: periocular triamcinolone acetonide; intravitreal~     triamcinolone acetonide; intravitreal dexamethasone implant. The primary efficacy measure~     will be percent change in central subfield thickness as measured by OCT at 8 weeks.~     Participants will continue in the study for 24 weeks in order to evaluate relative effects of~     the 3 treatment strategies on the duration of treatment effects, requirement for additional~     injections, and adverse effects.~   "
91154|NCT02374047|"~     This is a 2-part, Phase 1, placebo-controlled, double-blind, randomized, single and multiple~     ascending dose study. CAT-2054 will be administered either as an uncoated capsule (CAT-2054)~     or a coated capsule (CAT-2054-C). In Part A, CAT-2054 or placebo is administered as a single~     dose in a fasting state at 4 dose levels; at 3 dose levels, subjects will return for a second~     dose of the study drug after a high-fat meal. Additionally, at 1 dose level, CAT-2054-C or~     placebo will be administered as a single dose in a fasting state, and subjects will return~     for a second dose of the study drug after a high-fat meal. In Part B, CAT-2054 will be~     administered as multiple ascending doses at 4 dose levels for 14 consecutive days. In~     selected cohorts, CAT-2054, CAT-2054-C or CAT-2054 with atorvastatin will be dosed to assess~     safety in anticipation of future clinical trials.~   "
91155|NCT02374034|"~     The primary purpose of this experimental study was to determine the acute effect following~     one treatment and the short-term effect after a two-week program of Egoscue corrective~     exercises on chronic knee and hip pain.~   "
91156|NCT02374021|"~     In a randomized controlled clinical trial, investigators will compare the effects on~     [18F]-fluorodeoxyglucose positron emission tomography-computed tomography (FDG PET/CT) from~     two treatment regimens in rheumatoid arthritis (RA) patients deemed methotrexate inadequate~     responders (MTX-IRs). Two common RA treatments will be compared: triple therapy~     (sulfasalazine, methotrexate, and hydroxychloroquine) versus tumor necrosis factor (TNF)~     inhibitor (etanercept or adalimumab, plus background methotrexate for all subjects and~     hydroxychloroquine for subjects who were taking this at screening).~   "
91528|NCT02369146|"~     The purpose of this phase II study is to evaluate the safety, tolerability and efficacy of~     two multi-dose regimens of UB-421 monotherapy in replacement of HAART in HIV-1 infected~     adults with virological suppression.~   "
91157|NCT02374008|"~     Purpose:~      The purpose of this study is to evaluate the postoperative analgesic effect of a combined~     Saphenous nerve block and Obturator nerve block with local infiltration analgesia in the~     tissue around the knee after total kneearthroplasty. In the combined nerve blocks we use a~     mixture of Ropivacaine and Adrenaline combined with high dose systemic dexamethasone and~     Ketorolac and the mixture for local infiltration consist of Ropivacaine, Adrenaline and~     Ketoroloc. The investigators hypothesis is that the combined nerve blocks reduces pain and~     reduces the opioid consumption and thus reduce side effects such as nausea, vomiting and~     lethargy compared to the current treatment with local infiltration analgesia.~      Background:~      Nerve blocks as analgesic treatment after orthopedic surgery is a recognized and proven~     procedure. The nerve blocks have the disadvantage that not only do they anesthetize the~     sensory nerve fibers but also the nerve fibers to the muscles of the leg. The Saphenous nerve~     block causes only stunning of sensory nerves to the knee region. The Obturator nerve block~     causes both stunning of the sensory nerves to the knee region and the thighs inward leading~     muscles, and does not affect the patient's mobilization capacity.~      Both blocks are known to be a good addition to the analgesic treatment. Ropivacaine is a~     well-known local anesthetic. Adrenaline have also been used in other studies, in addition to~     the local anesthetic agent, and has been shown to prolong the effect of the nerve block.~     Saphenous and Obturator nerve block with all four drugs Ropivacaine and Adrenaline combined~     with high dose systemic Dexamethasone has not been systematically investigated in knee~     replacement surgery, and it is not known whether this method will provide better pain~     treatment.~      Method~      The patient can receive one of two treatments, determined randomly:~        -  A. Saphenous and Obturator nerve block with active anesthetics (Ropivacaine, Adrenaline)~          combined with systemic ketoroloc and high dose Dexamethasone and local infiltration~          around the knee joint with placebo medicine (normal saline).~        -  B. Both blocks with placebo medicine (normal saline) and local infiltration around the~          knee joint with activ local anesthetic.~      Neither patient, investigator or staff around the patient will have knowledge of which~     treatment the patient has received.~      The blocks will be placed before the operation and local infiltration around the knee joint~     will be given by the surgeon during the operation.~   "
91158|NCT02373995|"~     Graves' orbitopathy (GO), also known as thyroid eye disease, affects approximately 3 million~     people in Europe with an estimated socioeconomic burden of 6.4 billion euros per annum. GO is~     a complication of Graves' disease which is an autoimmune disease and the commonest cause of~     an overactive thyroid gland. The treatment of GO remains unsatisfactory and the majority of~     patients report long-term impairment of quality of life. The effects of gut derived antigens,~     from micro-organisms and nutrients, on the autoimmune response will be tested in the animal~     model by probiotic and contra-biotic intervention. In the Indigo interventional trial the~     investigators will add to the standard anti-thyroid drug treatment (ATD) a specifically~     designed probiotics (LAB4, Cultech Ltd., West Glamorgan, UK) to assess whether it is possible~     to modify the microbiome in GD patients and improve their immunological status.~   "
91159|NCT02373982|"~     This is a Multicenter Observational 1-year retrospective cohort study evaluating the~     predictive value of the Left Atrial Sphericity on the recurrence rate of atrial fibrillation~     after pulmonary vein ablation procedure.~      Inclusion of consecutive patients undergoing AF ablation during 2013 in whom a 3D-imaging of~     the left atrium (Cardiac CT or MRA) was acquired prior to the procedure and when~     procedural/follow-up data was prospectively collected.~   "
91160|NCT02373969|"~     Verify the changes in coagulation system during total knee replacement surgery with~     tranexamic acid single bolus infusion.~   "
91161|NCT02373956|"~     The main objective of this study is to document the effectiveness of a honey-based medical~     device (Hyalumel) in the management of pressure ulcers. The effectiveness of the medical~     device will be judged according to the evolution of the surface of the wound at the end of 12~     weeks of treatment.~   "
91162|NCT02373943|"~     The main objective of this human trial is the demonstration that β-carotene in fortified~     maize has good bioavailability as a plant source of vitamin A and that when humans ingest the~     biofortified product retinol levels are higher than when they ingest non biofortified white~     maize.~   "
91163|NCT02373930|"~     Treatment of human immunodeficiency virus (HIV) infection requires daily oral administration~     of a combination of antiretroviral drugs to reduce the patient's HIV levels. Dolutegravir~     (DTG), a HIV-1 integrase inhibitor (INI), and Rilpivirine (RPV), a non-nucleoside HIV-1~     reverse transcriptase inhibitor (NNRTI), are approved for the treatment of HIV infection.~     This study is aimed to evaluate the relative bioavailability and food effect of single doses~     of several experimental fixed dose combination (FDC) tablets of Dolutegravir 50 milligrams~     (mg) and Rilpivirine 25 mg (DTG/RPV 50 mg/25 mg) relative to co-administration of a single~     dose of the reference single entity products (DTG 50 mg and RPV 25 mg) in healthy adult~     subjects. This is a 2-part study. Part 1 will be conducted as a randomized, open label,~     3-way, crossover design in 24 subjects. Part 1 will evaluate the relative bioavailability of~     up to 4 test formulations relative to the reference single entity products administered in~     fed state. Part 2 will be conducted as a randomized, open-label, 3-way crossover design in 3~     distinct cohorts each with 12 subjects. Part 2 will evaluate the relative bioavailability of~     up to 3 most promising FDC formulation selected from Part 1 (DTG/RPV FDC-1, DTG/RPV FDC-2,~     DTG/RPV FDC-3) administered in fasted and fed state. Subjects will also receive the reference~     treatment from Part 1 co-administered under fasted conditions. This study will consist of a~     screening visit, three treatment periods each with a single dose of study drug separated by a~     washout of at least 9 days and a follow-up visit. The total duration of participation of a~     subject in this study will be approximately 10 weeks.~   "
91164|NCT02373917|"~     In this study the investigators will collect Blood,sputum and saliva samples for~     Characterization of Methylation Patterns in lung Cancer.~   "
91165|NCT02373904|"~     The purpose of this study is to collect safety and performance data of the Photodynamic Bone~     Stabilization System (PBSS) when used for the treatment of painful impending and actual~     fractures of the humerus secondary to metastatic cancer.~   "
91166|NCT02373891|"~     Acebrophylline is metabolized by being separated into Ambroxol and 7-theophylline when orally~     administered as a salt composed of an acid-base as a compound that was synthesized by and~     chloride (salifying) the ambroxol to 7-theophylline. Acebrophylline is selectively applied to~     the bronchial or lung tissue and inhibit the activity of phospholipase bronchoalveolar shows~     the expectorant action to raise the surface activity of the alveolar, leukotrienes (LTs) and~     by suppressing the production of prostaglandins (PGs), showed potent anti-inflammatory~     activity, bronchial was celebrated by reducing the bronchial hyperreactivity to normal state~     is allowed to recuperate or extended.~      It was developed to improve compliance improve pharmaceutically Acebrophylline that intake~     twice daily 100mg to Surfolase CR that intake once daily 200mg~   "
91167|NCT02373878|"~     The purpose of this study was to evaluate the impact of telecoaching conducted by a counselor~     trained in motivational interviewing paired with a portion control device for obese patients~     receiving care in a certified patient-centered medical home. The investigators will conduct a~     randomized, controlled clinical trial evaluating the effectiveness of a telecoaching~     intervention with a portion control device.~   "
91168|NCT02373865|"~     This exploratory double blind randomized active controlled study is designed to assess the~     effects of a treatment with therapeutical dosage of sitagliptin versus therapeutical dosage~     of glimepiride as add on therapy in patients with diabetes mellitus type 2 (T2DM) patients~     inadequately controlled on metformin monotherapy.~   "
91170|NCT02373839|"~     Preeclampsia is an important disease that develops during pregnancy and it is one of the main~     contributors to maternal and fetal complications.~      The only known definitive treatment is delivery. Although delivery is always appropriate for~     the mother, it might not be the best for a very premature neonate.~      In cases of non-severe preeclampsia there no benefit delaying delivery beyond 37 weeks. It is~     also well established that before 34 weeks an expectant management confers perinatal benefit~     with minimum amount of additional maternal risk. There is then an area of uncertainty between~     37 and 37 weeks. This is why in this period it is a clinical need to select high risk~     patients of complications that will benefit from labor induction, and differentiate them from~     low risk patients that can be manage expectantly until 37 weeks.~      Placental growth factor (PlGF) is an angiogenic factor that is lower in pregnant women with~     preeclampsia and current evidence shows that it as a predictor of adverse pregnancy outcome~     and requirement of delivery.~      Circulating levels of PIGF at 34 weeks could help to identify those women that may benefit~     from labor induction and those where delivery can be delayed until 37 weeks with low risk for~     maternal complications.~   "
91171|NCT02373826|"~     During coronary angiography, the lumen of the arteries is imaged but intravascular ultrasound~     (IVUS) is necessary to determine the plaque extension and its composition, lesion length and~     luminal reference diameter. We aimed to investigate the accuracy, feasibility, safety and~     value of a novel method for co-registration of IVUS and coronary angiographic images.~   "
91172|NCT02373813|"~     The purpose of this study is to evaluate the efficacy of etanercept monotherapy compared to~     methotrexate monotherapy on maintenance of remission in subjects with Rheumatoid Arthritis~     who were on etanercept plus methotrexate therapy.~      This is a multicenter, randomized withdrawal, double-blind controlled study in subjects with~     Rheumatoid Arthritis on etanercept plus methotrexate therapy who are in very good disease~     control for 6 months prior to study entry. The study will consist of a 30-day screening~     period, a 24-week open label run-in period, a 48-week double-blind treatment period and a~     30-day safety follow-up period.~      Approximately 358 subjects will be enrolled and approximately 250 subjects will be randomly~     assigned in a 2:2:1 ratio to one of three treatment groups: etanercept 50 mg weekly by~     subcutaneous injection plus oral placebo for methotrexate (n = 100), oral methotrexate 10 to~     25 mg weekly plus placebo for etanercept (n = 100) and etanercept 50 mg weekly by~     subcutaneous injection plus oral methotrexate 10 to 25 mg weekly (n = 50).~   "
91173|NCT02373800|"~     The primary objective of this study is to determine if a cervical hardness score (determined~     by cervical ultrasound with elastography) can predict delivery mode (vaginal versus cesarian~     for slow dilatation (more than 2-3h without fetal suffering) regardless of the induction mode~     (ocytocin alone or with an intravaginal device releasing PGE2).~   "
91174|NCT02373787|"~     A 5-year clinical investigation on creos xenoprotect~   "
91175|NCT02373774|"~     The purpose of this study is to determine if performing an ultrasound to identify the space~     to insert the needle before performing a lumbar puncture will improve success of the~     procedure and patient safety.~   "
91176|NCT02373761|"~     This study seeks to find out if the tibial and patellar components of the Stryker Triathlon~     Tritanium primary total knee replacement achieve adequate fixation to the underlying bone.~   "
91177|NCT02373748|"~     The purpose of this study is to evaluate the movements performed according to the BioGaming~     YuGo software, and verify that they are rehabilitation movements.~   "
91178|NCT02373735|"~     The purpose of this study is to investigate the effect of stroke volume variation (SVV)~     guided fluid therapy on the blood loss and postoperative outcomes in radical cystectomy.~   "
91179|NCT02373722|"~     This randomized clinical trial studies how well website application (web app) based education~     and text messaging works in improving skin wound care in patients undergoing Mohs surgery (a~     surgical procedure used to treat skin cancer). Website application and text messaging based~     education may help patients stick to wound care instructions before and after surgery, lower~     anxiety level, and may help monitor their activity.~   "
91180|NCT02373709|"~     To elucidate the disease pathway of perinatal depression by identifying genetic variants~     which could play a role in predisposing to the condition and/or lead to better understanding~     of the pathogenesis of the condition. This is achieved by investigating for associations~     between oestrogen receptor genetic variants and perinatal depression.~   "
91181|NCT02373696|"~     Incidence and risk factors for persistent post surgical pain after Caesarean section are~     investigated. Demographic, psychophysical testing and genetic screening factors are performed~     in the perioperative period. Phone survey is performed to investigate the incidence of~     persistent post surgical pain after Caesarean section.~   "
91182|NCT02373683|"~     The aim of this prospective pilot study is to determine the effect of heliox delivered via a~     proprietary calibrated heated and humidified high flow nasal cannula (HFNC) system (Vapotherm~     Precision Flow Heliox) in children ages 0-24 months with severe bronchiolitis.~   "
91183|NCT02373670|"~     A feasibility study randomizing participants (parents of children age 2-5 years old) to~     receive either education or a parent mentor with the aim of improving health behaviors and~     improving their body mass index z-score.~   "
91196|NCT02373501|"~     To evaluate the effects of extra-abdominal repair of the uterine incision compared to~     intra-abdominal repair, and to study is there superiority of one technique over the other in~     terms of primary outcomes - operative( up to 4 hours after beginning of anesthesia) and post~     operative ( until day 4 after operation ) measurements , secondary outcomes, long-term~     outcomes and subjective outcomes.~      PRIMARY OUTCOMES:~      Intra - operative ( during the operation up to 4 hours from anesthesia )~        -  nausea and vomiting~        -  intraoperative hypotension~        -  intraoperative pain~      Post operative ( 4 hours from anesthesia and until release from hospital )~        -  Blood transfusion~        -  Venous thromboembolism~        -  Febrile Morbidity~        -  Endometritis~        -  Wound Infection~        -  Death~      Subjective measures:~        -  complain of pain 1-10 on day 1 post operative~        -  time until walking~        -  number of Days until having bowel movement~        -  overall satisfactory~      SECONDARY OUTCOMES:~        -  Operative time~        -  Estimated blood loss ( ebl ) - hemoglobin levels~        -  Hospital stay~   "
94902|NCT02324946|"~     The DES-OSA Score and the STOP-BANG score were predictive scores for Obstructive Sleep Apnea.~      This study will compare, among patients scheduled for bariatric surgery, these two scores as~     predictive scores for a difficult intubation.~   "
91184|NCT02373657|"~     Trachoma is a blinding disease caused by ocular strains of Chlamydia trachomatis. The Carter~     Center and Proctor Foundation have been jointly conducting trachoma research in the Goncha~     Siso Enese woreda of Amhara for the past 8 years, through a series of clinical trials. We~     have found that repeated mass administration of oral azithromycin can greatly reduce the~     prevalence of trachoma, but mass antibiotics have been unable thus far to eliminate~     infection. The World Health Organization recommends not only antibiotics for control of~     trachoma, but an entire SAFE strategy (Surgery for in-turned eyelids, Antibiotics, Facial~     hygiene promotion, and Environmental improvements such as latrines and water points).~     Trachoma is more common in villages and households with poor access to water and latrines, so~     improving the public health infrastructure is thought to be important for limiting~     transmission of trachoma. However, there is very little evidence to support the efficacy of~     installing new water points for trachoma. There has been only one previous attempt to study~     the role of hand dug well installation for trachoma control, and this study, conducted in~     Niger, found that installing wells was not effective. We now propose a project to improve the~     public health infrastructure of Goncha Siso Enese woreda by helping with the construction of~     water points (e.g., hand-dug wells) and providing hygiene education, in order to determine~     whether improving access to water and hygiene information will be effective for control of~     trachoma and soil-transmitted helminths.~   "
91185|NCT02373644|"~     The purpose of the research project is to compare the effectiveness of non-thrust~     mobilization and exercise versus thrust manipulation and dry needling in patients with~     sacroiliac dysfunction. Physical therapists commonly use both approaches to treat sacroiliac~     joint dysfunction, and this study is attempting to determine if one approach is more~     effective than the other.~   "
91186|NCT02373631|"~     The purpose of this research is to compare the effectiveness of conventional physical therapy~     (manual physical therapy, exercise, range of motion, and stretching) versus conventional~     physical therapy combined with dry needling in patients with knee osteoarthritis (OA).~     Physical therapists commonly use conventional physical therapy techniques and dry needling to~     treat knee OA, and this study is attempting to find out if the addition of dry needling to~     conventional physical therapy has an equal, greater, or lesser effect than conventional~     physical therapy alone.~   "
91187|NCT02373618|"~     The purpose of this research is to compare patient outcomes following treatment of plantar~     fasciitis with conventional physical therapy (stretching, strengthening, ultrasound, manual~     therapy, and cryotherapy) and conventional physical therapy plus dry needling. Physical~     therapists commonly use conventional physical therapy techniques and dry needling to treat~     plantar fasciitis, and this study is attempting to find out if the addition of dry needling~     to conventional physical therapy is more effective than conventional physical therapy alone.~   "
91188|NCT02373605|"~     The purpose of this research is to compare two different approaches for treating patients~     with cervicogenic headaches: non-thrust mobilization and exercise versus thrust manipulation~     and dry needling. Physical therapists commonly use all of these techniques to treat~     cervicogenic headaches. This study is attempting to find out if one treatment strategy is~     more effective than the other.~   "
91189|NCT02373592|"~     This study aims to implement daily temperature measurements of feet complemented by SMS and~     voice messaging to prevent diabetic foot ulcers in patients with type 2 diabetes mellitus at~     high risk of ulceration.~      Design: Physician-blinded, randomized, 18-month trial.~      Setting: Diabetes outpatient clinics from two public hospitals~      Population: Subjects will be eligible if they (1) have a diagnosis of type 2 diabetes~     mellitus, (2) are between 18 - 80 years of age, (3) have a present dorsalis pedis pulse in~     both feet, (4) are in risk group 2 or 3 using the diabetic foot risk classification system as~     specified by the International Working Group on the Diabetic Foot, (5) have an operating cell~     phone or a caregiver with an operating cell phone, and (6) have the ability to provide~     informed consent.~      Hypothesis: The investigators hypothesize that implementation of an enhanced intervention~     that combines daily temperature measurement for the reduction of diabetic foot ulcer with SMS~     and voice messaging will improve patient measurement compliance and reduce diabetic foot~     ulcers in a middle income country.~   "
91190|NCT02373579|"~     Study the role of oxidative stress in methotrexate induced hepatic damage, and the possible~     protective effect of OMEGA-3 fatty acids against methotrexate hepatotoxicity using clinical~     and biochemical parameters.~   "
91191|NCT02373566|"~     In this study the efficacy of an acellular dermal template (Novomaix), combined with split~     thickness skin grafts, for use in patients with full thickness skin defects, is tested.~     Results will be compared intra-patient with those obtained after conventional treatment with~     split thickness skin grafts. The investigators expect this treatment to provide better~     outcome regarding scar quality.~   "
91192|NCT02373553|"~     MB Children maintains the same postural pattern in preoperative and postoperative~     adenotonsillectomy? The age influences the incidence of more exacerbated postural changes?~     The proposed early physiotherapy intervention can minimize future functional deficits? Trying~     to answer some of these questions, the objective of present study is to investigate the~     initial kinematics of the shoulder girdle, cervical and thoracic spine in MB children pre and~     post adenotonsillectomy and then evaluate the effects of a physical therapy intervention~     program for MB children who persisted with postural changes.~   "
91193|NCT02373540|"~     The purpose of this study is to obtain real-world clinical outcome data for the Algovita~     Spinal Cord Stimulation system when used, on-label, according to the applicable directions~     for use.~   "
91194|NCT02373527|"~     The purpose of this study is to compare the safety and effects of fasting or not fasting~     overnight before a cardiac catheterization (heart procedure). The study will compare patients~     who have nothing to eat after midnight before the procedure to those who are allowed to eat~     or drink before the procedure.~   "
91195|NCT02373514|"~     Patients presented with dysmenorrhea composed the study population. One gram paracetamol and~     50 mg dexketoprofen in 100 ml saline with a rapid infusion were compared in ceasing~     dysmenorrhea in emergency department.~   "
91233|NCT02373020|"~     Despite the characterization of many aetiologic genetic changes. The specific causative~     factors in the development of sporadic colorectal cancer remain unclear. This study was~     performed to detect the possible role of Enteropathogenic Escherichia coli (EPEC) in~     developing colorectal carcinoma.~   "
91197|NCT02373488|"~     The aim of this study is to investigate the effect of connective tissue manipulation and~     abdominal massage on severity of constipation and health related quality of life in patients~     with chronic constipation. According to literature, there are studies that investigate the~     effects of abdominal massage on bowel movements. But there is no randomized controlled trial,~     explore the short and long-term effects of different massage technics on chronic~     constipation. Hypothesis of this study is that connective tissue manipulation and abdominal~     massage improves symptoms of constipation and health related quality of life in patients~     suffering with constipation.~   "
91198|NCT02373475|"~     Postoperative pulmonary complications are main cause of overall perioperative morbidity and~     mortality in the patients following general anesthesia. A protective ventilation strategy~     refers to the use of low VT (in the range of 4-8 ml/kg of the predicted body weight) with~     positive end-expiratory pressure (PEEP), with or without recruitment maneuver. Protective~     ventilation has been considered the optimal practice in patients suffering from the acute~     respiratory distress syndrome (ARDS). However, few human studies have assessed how to~     ventilate healthy lungs in patients undergoing general anesthesia, especially in prone~     position. Prior studies reported that in the patients undergoing major abdominal surgery in~     supine position, intraoperative lung protective ventilator settings had the potential to~     protect against pulmonary complications. Therefore, the investigators planned this study to~     better specify the effect of intraoperative protective ventilation in surgical patients in~     the prone position.~   "
91199|NCT02373462|"~     To study the effect of olmesartan on walking distance and quality of life in peripheral~     artery disease patients with hypertension treated For intermittent claudication.~   "
91200|NCT02373449|"~     Neuropathic or nerve injury related pain (NP), an extremely unpleasant condition that is~     difficult to treat, often has a severe, persistent, and unremitting course. Conventional~     treatments are often ineffective in relieving NP. Recently, the investigators have developed~     a cost-efficient regimen involving use of low dose infusions of ketamine for treating~     neuropathic pain in patients in whom oral medications have failed. We have observed excellent~     benefits in many of these patients. However, this treatment requires titration and monitoring~     during the infusion and currently it is not possible to predict which patients will benefit~     from this intervention. The investigators have shown that functional magnetic resonance~     imaging (fMRI) of the brain can be used as a tool to predict relief of pain and to assess the~     effect of treatment in some chronic pain conditions. This innovative project involves~     development of an fMRI-guided treatment with intravenous ketamine in patients with NP. This~     study aims to analyze patterns of changes in fMRI of the brain, before and after infusion of~     ketamine and to correlate the changes with pain intensity. The information from this study~     will help to deliver this therapy earlier to those patients who are most likely to benefit~     from ketamine.~   "
91201|NCT02373436|"~     The hemiparesis is one of the most important sequelae of stroke, and generally have greater~     impairment in the upper limb (UL) contralateral to the brain injury. To obtain greater amount~     of use and most affected UL movement quality, studies have described as a rehabilitation~     technique constraint Induced Therapy (CIT). The objectives of this study will evaluate the~     effect of CIT in severe hemiparetics patients in the quantity and quality of movement UL and~     grip strength, and the relation between the scapular kinematics and trunk with the quality of~     movement measured clinically. Randomized crossover study with systematic reviews in AB mode,~     where A is the baseline to the evaluation of the period of 2 weeks without any intervention~     and B, the two-week period with intervention. One group will start with the intervention~     period (BA) and the other group with the period without intervention (AB). The intervention~     will be for 3 hours / day, 5x / week for two weeks and use of wrist and fingers restriction~     UL unaffected. To evaluate the quality and quantity of UL use in real environment will be~     used to Motor Activity Log (MAL), to quantify the motor skill the Wolf Motor Function Test~     (WMFT), the 3D movement of the scapula and trunk during arm elevation and functional~     activities of the UL will be measured by the electromagnetic tracking system and grip~     strength by hand dynamometer.~   "
91202|NCT02373423|"~     A clustered-randomized controlled trial in which 45 food companies are the unit of~     randomization. The intervention companies will receive an advocacy program which comprises of~     commonly used advocacy actions, incorporating a theory of change model. The control companies~     will have no specific intervention targeted at them. The aim of this study is to quantify the~     effects of advocacy delivered by a local non-government organization on the salt content of~     food products produced or marketed by companies in Australia.~   "
91203|NCT02373410|"~     The purpose of this study is to analyze the accuracy of needle insertion and the discomfort~     during different ergonomic conditions faced by anesthesiologists during spinal anesthesia. In~     particular,the investigators intend to compare the angles between the patients' back and the~     inserted spinal needle in the coronal plane at different operating table heights.~   "
91204|NCT02373397|"~     The objective of this clinical study is to test the efficacy of CACICOL20® (RGTA OTR 4120) in~     improving wound healing and nerve regeneration in the anterior cornea, in a patient~     population undergoing therapeutic laser treatment for corneal dystrophy or recurrent corneal~     erosions.~   "
91205|NCT02373384|"~     The aim of the study is to evaluate the predictors of success of oral dissolution therapy in~     radiolucent renal stones in a large series of patients from a tertiary referral center in~     order to define the optimum case scenarios where oral dissolution therapy could be~     implemented.~   "
91206|NCT02373371|"~     The main objective of this study is to compare efficacy and safety of Metvix® natural~     daylight photodynamic therapy with those of Metvix® conventional photodynamic therapy in~     subjects with mild actinic keratoses (intra-individual comparison)~   "
91234|NCT02373007|"~     The purpose of this study is to show that the modified technique Scopinaro surgery allows a~     better control or reduction of complications often found in nutritional pancreatic and~     biliary derivations, starting from the assumption of a modified technique is as effective as~     Scopinaro classical technique for reducing overweight and control of comorbidities in obese~     patients with grade II and III.~   "
91529|NCT02369133|"~     The investigators designed a prospective randomized study to investigate the efficacy of~     intravenous (IV) preemptive paracetamol on postoperative pain scores, patient satisfaction,~     total morfin consumption and the incidence of morfin‑related side effects in patients~     undergoing cesarean section.~   "
91207|NCT02373358|"~     Neuroscience evidence indicates that trauma is stored in the body, that trauma impairs the~     language centers found in the brain, and that emotion centers in the brain tend to override~     cognitive centers in the brain following trauma. Most evidence-based models to date to treat~     trauma using cognitive therapy, which does not fully resolve symptoms, particularly in the~     case of complex trauma. This evidence has led to researchers to call for alternative,~     body-oriented treatments that target trauma from the lowest levels of regulation up to higher~     levels of regulation in the brain. Yoga has been proposed as one such intervention. Recent~     research has investigated the benefits of yoga to treatment adult females who have~     experienced PTSD, but only anecdotal, descriptive, and qualitative data is available for~     studies of yoga with adolescents. This mixed methods study seeks to generate quantitative~     data demonstrating whether or not the 6-week group yoga intervention leads to decreases in~     general mental health and trauma-specific symptoms and qualitative data regarding the~     components of the intervention the participants found both helpful and unhelpful.~   "
91208|NCT02373345|"~     The purpose of the present study is to determine the association between factors known to be~     associated with the development of chronic low back pain (psychological and biological) and~     the evolution of functional disability in individuals with a history of low back pain. To do~     so, 100 individuals with a history of nonspecific low back pain will be followed over a~     period of 18 months. During this time frame, participants will be evaluated three times in~     the laboratory (initial, at 6 months and at 18 months) to determine pain and tolerance~     thresholds, pain inhibition processes as well as neuromuscular activation. Moreover, these~     participants will be assessed every three months (initial, 3, 6, 9 12, 15 and 18 months) for~     functional disability and pain intensity levels of their low back pain as well as for~     psychological symptoms usually associated with the development of chronic low back pain. It~     is hypothesized that high psychological symptoms measured initially will be associated with~     high functional disability throughout the study .~   "
91209|NCT02373332|"~     This study investigates the potential protective effects of altering fatty acid in the~     platelet as a method for prevention of platelet activation and thrombosis in type 2 diabetes~     mellitus. Fatty acids (omega-3 and omega-6) and their oxidized lipids will be evaluated for~     protection from agonist-mediated platelet activation in platelets from type 2 diabetics and~     healthy controls.~   "
91210|NCT02373319|"~     The aims of this study are (1) to validate a self-screening method for cardiovascular (CV)~     risk that does not require the supervision of a health professional (including~     self-measurement of blood pressure, lipid profile evaluated by dry chemistry, and~     self-administered questionnaires on sex, age, diabetes, and tobacco consumption). (2) From~     these data, the investigators will generate personalized recommendations based on the best~     available evidence. The investigators will also analyze whether this innovative approach~     improves adherence to preventive recommendations for cardiovascular and other chronic~     diseases.~   "
91211|NCT02373306|"~     Implantable cardioverter-defibrillator (ICD) is a widely used and effective therapy which~     reduces the risk of cardiac death in many cardiac diseases, both implanted for secondary and~     primary prevention. It is known that recurrent arrhythmias and ICD discharges have adverse~     prognostic significance. Parameters that would identify patients who are at increased risk of~     arrhythmias and appropriate ICD interventions would be of clinical value. The aim of the~     study is to evaluate the usefulness of non-invasive programmed stimulation (NIPS) in~     determining the likelihood of life-threatening arrhythmic events in patients with ICD.~   "
91212|NCT02373293|"~     This is an epidemiological, observational, prospective, multicentric study in 400 adult~     patients admitted to hospital for mild acute pancreatitis to to assess the prognostic value~     of the antithrombin III in the development of moderate or severe acute pancreatitis.~   "
91213|NCT02373280|"~     To compare the eradication success rate between 10-days sequential therapy and 7-days~     tailored therapy based on H. pylori culture and antimicrobial susceptibility testing.~   "
91214|NCT02373267|"~     Screening of TMA patients for ADAMTS13 activity and the description of systemic organ damage~     and/or organ failure in different entities of thrombotic microangiopathies (TMA)~   "
91215|NCT02373254|"~     This study is being conducted to evaluate whether NSAIDS are more or less effective in bone~     healing than opioids in acute fracture pain. Participants will be randomized to one of three~     groups for first line treatment of pain related to the fracture.~   "
91216|NCT02373241|"~     Untreated hypertension and renal injury are risk factors for increased morbidity and~     mortality in sickle cell disease, yet early markers of progressive disease have not been~     identified and therapies to prevent the development of adverse cardiovascular outcomes have~     not been defined. Circadian blood pressure, as defined by 24 hour blood pressure monitoring,~     is more accurate than clinic blood pressure in defining secondary hypertension and abnormal~     nocturnal blood pressured dipping and nocturnal hypertension have been linked to progressive~     renal disease in other diseases.~      Methodology/Aims: A randomized feasibility trial of losartan will be conducted among~     adolescent HbSS and SB0 thalassemia patients (11-19 years) with abnormal nocturnal blood~     pressure dipping. During this six month feasibility trial, two dosing strategies of losartan~     (titrated to keep clinic BP <95th percentile vs. <75th percentile) will be analyzed for~     safety and effect on restoring normal circadian blood pressure.~      A prospective cohort study among HbSS and SB0 thalassemia patients (6-19 years) will also be~     conducted to evaluate the incidence of hypertension and role of monitoring potential~     biomarkers of kidney injury and hypertension. Cohort participants will undergo annual~     evaluations of hypertension(24 hour blood pressure monitoring for participants ≥ 11yrs,~     clinic BP in all participants) and markers of kidney injury/hypertension.~      Expected Results: At the completion of the feasibility trial, vital background information~     will be obtained to design a definitive multicenter trial of hypertension in sickle cell~     disease. At the completion of the cohort study, the incidence of pediatric hypertension will~     be identified and the role for monitoring blood and urine biomarkers will be better~     understood.~      As therapy for patients with renal failure is dismal, it is imperative that SCD patients at~     risk are identified early and that therapeutic trials are conducted that prevent progression.~   "
91217|NCT02373228|"~     Hearing impaired persons suffer from inferior music perception with and without hearing aids.~     Hearing aids, however, are primarily designed to improve speech intelligibility not music~     enjoyment. This study investigates the potential benefit of signal processing strategies that~     are optimized for music. The purpose of this study is to improve music compression for~     hearing impaired people.~   "
91218|NCT02373215|"~     This is a single-center clinical research study with the purpose to evaluate the safety,~     tolerability, and pharmacokinetics (PK) of nalbuphine HCl ER (extended release) tablets in~     end-stage renal disease (ESRD) patients receiving hemodialysis (HD) therapy and reporting~     pruritus.~   "
91219|NCT02373202|"~     Primary Objective:~      To document the long-term safety of sarilumab added to non-methotrexate (non-MTX)~     disease-modifying antirheumatic drugs (DMARDs) or as monotherapy.~      Secondary Objective:~      To document the long term efficacy of sarilumab added to non-MTX DMARDs or as monotherapy.~   "
91220|NCT02373189|"~     Nearly 50% of U.S. veterans report they experience pain on a regular basis. This chronic pain~     often co-occurs with other disorders including post-traumatic stress disorder (PTSD),~     depression, anxiety and insomnia. A common approach to treating chronic pain is opioid~     analgesics, which are not always effective, and increasingly associated with abuse and~     misuse. Thus, there is an urgent need to develop readily available, safe, and practical~     complementary nonpharmacological approaches to manage chronic pain in U.S. veterans. Chronic~     pain is a multidimensional phenomenon, inter-related with many factors, including negative~     mood and poor sleep. The central circadian clock, in the suprachiasmatic nucleus in the~     hypothalamus, is well recognized to regulate both mood and sleep, and even small delays~     (shifts later) in circadian/sleep timing are associated with depression and disrupted sleep.~     These results suggests that later circadian/sleep timing may be a modifiable risk factor for~     pain. Thus, a self-administered morning bright light treatment at home may be a potentially~     efficacious adjunctive strategy for managing chronic pain. This R34 grant will develop a~     morning bright light treatment to help manage chronic pain and improve PTSD symptoms,~     depression, anxiety and sleep in U.S. veterans. Patients will have 7 baseline days at home,~     followed by a baseline pain sensitivity assessment and home circadian phase assessment (dim~     light melatonin onset). Following an instructional home visit, patients will then~     self-administer morning bright light treatment for 6 days, followed by reassessments of pain~     sensitivity and circadian phase. Assessments will be repeated after another 7 days of morning~     bright light treatment. Pain, mood and sleep (wrist actigraphy) will be assessed daily~     throughout baseline and treatment. Pain, mood and sleep will also be rated by veterans daily~     during a 1 month follow up after cessation of light treatment. This study will determine the~     feasibility, acceptability and efficacy of bright light treatment in a sample of U.S.~     veterans experiencing chronic low back pain.~   "
91221|NCT02373176|"~     [14C]PRC-4016 (Icosabutate) - A Phase I, Open-Label Study of the Absorption, Metabolism and~     Excretion Following Oral Dosing to Healthy Male Subjects.~      Objective: To evaluate the pharmacokinetics of total radioactivity in blood and plasma and~     PRB-01022 (icosabutate) (unchanged drug) in plasma following a single oral administration of~     [14C]PRC-4016 to healthy male subjects.~      To obtain a mass balance of oral [14C]PRC-4016 by quantifying the urinary and faecal~     excretion of radioactivity.~      To examine the profile of metabolites in plasma, urine and faeces. To further assess the~     safety and tolerability of a single oral dose of [14C]PRC 4016 in healthy male subjects.~   "
91222|NCT02373163|"~     This trial is designed to:~        1. Assess the response to montherapy with : a thiazide diuretic (HCTZ), a calcium-channel~          blocker (CCB, amlodipine) and an angiotensin-receptor blocker (telmisartan), among~          hypertensive subjects who live at sea level, at medium altitude above sea level and at~          high altitude above sea level.~        2. To test whether diferentes exist in the response to therapy among subjects who live at~          different altitude above sea level~        3. To assess the hemodynamic characteristics of hypertension in populations that live at~          sea level, at medium altitude above sea level, and at high altitude above sea level.~   "
91223|NCT02373150|"~     This study will assess the pharmacokinetics of single and repeated doses of imeglimin in~     healthy Japanese subjects, and the safety and tolerability of single and repeated doses of~     imeglimin in healthy Japanese subjects.~   "
91224|NCT02373137|"~     The purpose of this study is to compare visual acuity outcomes of two types of endothelial~     keratoplasty: 1) Ultrathin Descemet's Stripping Endothelial Keratoplasty (DSAEK) or 2)~     Descemet's Membrane Endothelial Keratoplasty (DMEK). Half of the participants will be~     randomized to have DSAEK and the other half will have DMEK.~   "
91225|NCT02373124|"~     This study evaluates the feasibility of a treatment paradigm that involves naturalistic~     cocaine use opportunities in the context of psychotherapy aimed at utilizing these~     opportunities therapeutically.~   "
91226|NCT02373111|"~     Photoaging is caused by the superposition of chronic ultraviolet (UV)-induced damage on the~     intrinsic aging process, and accounts for the majority of age-associated changes in skin~     appearance. Reactive oxygen species (ROS) play a key role in UV-induced skin damage and~     diminish skin matrix protein levels, leading skin aging. Strategies utilizing endogenous skin~     antioxidants as well as plant-derived or synthetic compounds have been examined.~      Astaxanthin mainly from marine algae and crustaceans is a kind of carotenoids which were~     well-known photo-protective agents with strong antioxidant activity. Several studies have~     revealed that supplementation of astaxanthin effectively protect skin against UV damage~     through free radicals.~      In addition, matrix metalloproteinase-1 induced by UV irradiation is an important step toward~     skin aging. Recently, many studies pointed out that phytoestrogens exhibit agonistic and~     antagonistic estrogen activities, suppressing activity of MMP-1 in skin. Isoflavone is a kind~     of phytoestrogen from soybean and mainly act on skin and bones, inhibiting MMP-1 effectively.~      The present study is designed to take isoflavone combined with astaxanthin to maximize their~     anti-aging ability and objectively measure the effects of the mixture on facial wrinkles,~     hydration, and elasticity.~   "
91227|NCT02373098|"~     The main purpose of this study is to measure the serum levels of cytokines and chemokines~     that are known to increase during multiple sclerosis relapses.~      Cytokines are a broad and loose category of small proteins that are important in cell~     signaling.~      The second purpose of the study is to test the cytokine/chemokine changes measured in the 3rd~     and 6th months on the efficacy parameters.~   "
91228|NCT02373085|"~     Antimicrobial treatment of asymptomatic bacteriuria (AB) in kidney transplant recipients~     (KTR) is controversial. The investigators performed a comparative, parallel-group,~     randomized, open-label study to assess, in a real clinical setting, the feasibility of and~     benefit derived from systematic search and antimicrobial treatment of all episodes of AB.~   "
91229|NCT02373072|"~     This is a study with two sequential cohorts, each with three treatment periods. Single doses~     of PF-06649751 will be tested in this study, starting at a low dose and escalating to a dose~     projected to be under the current limits for drug concentration. Each cohort will aim to~     achieve approximately 9 completers. Primary endpoint is safety and tolerability, secondary~     endpoint is MDS-UPDRS part III.~   "
91230|NCT02373059|"~     A research study to enhance clinical discussion between patients and pharmacists using a~     shared decision making tool for type 2 diabetes or usual care.~   "
91231|NCT02373046|"~     This is a randomized, single-center, open-label, 2-sequence, 2-period, single-dose, crossover~     study to assess the bioequivalence and the total 24-hour urinary glucose excretion (UGE) of~     400 mg LX4211 administered as a single 400-mg tablet compared to 2 × 200-mg tablets in~     healthy subjects under fasted conditions.~   "
91232|NCT02373033|"~     This study evaluates the effects of folate-rich foods regarding improvement of folate status~     compared with folic acid supplement. A randomized, parallel intervention trial with two~     active groups (folate-rich foods or folic acid supplement) and one control group (apple juice~     - 0 µg/d folate) was executed over 12 weeks.~   "
91557|NCT02368769|"~     The purpose of the study is to assess whether performing a frozen section diagnosis off site~     with virtual slides would be as quick and accurate as usual technique.~   "
91235|NCT02372994|"~     This project will pilot and test a new online communication tool, Loop, developed within a~     research framework with participatory and user-centred design. This pilot trial focuses on~     advanced cancer as an example of complex care. Cancer care involves many healthcare~     providers, spanning hospital to home. There is no organized way for them to communicate. Loop~     is a practical tool for ongoing collaboration in the patient's actual team of care that~     engages patients. The study will answer the questions: does Loop improve communication~     efficiency, engage patients and family physicians, and show early benefits in quality and~     health care costs?~   "
91236|NCT02372981|"~     Novel minimally invasive techniques were established for prolapsing haemorrhoids to minimise~     the drawbacks of the golden standard of haemorrhoidal treatment, conventional~     haemorrhoidectomy techniques. Ligation techniques, such as Doppler-guided haemorrhoidal~     artery ligation (DG-HAL), were introduced to reduce the arterial inflow of the AVP and thus~     prevent the haemorrhoidal zone from being part of the continence system. Apart from~     inappropriate application of this surgical alternative for higher grade haemorrhoids, high~     recurrence rates of up to 38% after DG-HAL are due to technical failure of the ligation~     technique itself. This is a prospective randomised controlled trial to evaluate the efficacy~     of additional Doppler-guided ligation of submucosal haemorrhoidal arteries in patients with~     symptomatic grade III haemorrhoids.~   "
91237|NCT02372968|"~     The aim of this pilot study is to develop at Nestlé Research Center a database of metabolic~     profiles, body composition, food habits and physical activities on a large cohort of human~     volunteers. Analysis of collected data will serve to measure the variability of the data and~     to assess the potential of combining metabonomics with imaging techniques (iDXA) to monitor~     the metabolic and physiologic effects of foods.~   "
91238|NCT02372955|"~     Dapagliflozin has been shown to lower clinic systolic and diastolic blood pressure in~     patients with type 2 diabetes mellitus. The exact mechanism(s) by which dapagliflozin lowers~     clinic SBP is unknown. The primary objective of the study is to determine the effect of~     dapagliflozin , 10 mg daily, on parameters of arterial stiffness: aPWV, augmentation index~     (AI), 24-hour blood pressure patterns, SBP, and pulse pressure. Urinary sodium excretion, and~     Intravascular volume status will be recorded. The study will involve 21 subjects for a~     duration of 16 weeks.~   "
91239|NCT02372942|"~     Primary endpoint will be evaluate the effectiveness of vaginal lactoferrin in the reduction~     of the 30% of preterm deliveries versus the use of progesterone, in specific selected~     patients, with consequent improvement in neonatal outcome.~      Secondary endpoint will be compare antibacterial and anti-inflammatory activity of~     lactoferrin by evaluation of systemic biochemical and urinary markers.~   "
91240|NCT02372929|"~     The primary objective of this study is to document all cases of EUS in patients with~     esophageal cancer and determine if the inability to advance the gastroscope beyond the tumor~     correlates with locally advanced disease stage at Endoscopic Ultrasound.~   "
91241|NCT02372916|"~     Given the aging population who will be affected by wet AMD and lack of effective GA~     treatment, it is crucial to assess the safety profile of repeated ranibizumab injections in~     AMD patients with GA, particularly the possible risk of GA development and enlargement. This~     potential adverse effect has significant implication in the discussions with patients~     regarding the risks and benefits of AMD treatment and injection frequency. While monthly~     injections provide slight improvement of visual acuity at 2 years (Martin et al., 2012), the~     risk of GA enlargement may offset this benefit in visual acuity.~      Previous studies assessed the association between intravitreal ranibizumab injections and de~     novo GA development in injection-naïve eyes (Martin et al, 2012, Querques et al., 2012.,~     Grunwald et al., 2014), rather than GA enlargement in patients with preexisting GA. To the~     best of the investigators knowledge, there has been no prospective study assessing the~     association between intravitreal ranibizumab injections and rate of GA progression in~     patients with pre-existing GA. There is also no prospective study comparing the morphological~     features of GA between patients who are receiving intravitreal injections and those who are~     not, nor the concordance of GA enlargement rate between the 2 eyes among patients receiving~     and not receiving treatment.~   "
91242|NCT02372903|"~     One of the main symptoms of endometriosis is pain, but his pathogenesis is not fully~     understood. The detection of mast cells in the endometriosis lesions supports the hypothesis~     that mast cell degranulation may contribute to development of pain and hyperalgesia.~      N-acylethanolamines (NAEs) are a class of endogenous compounds that regulate inflammation and~     pain, controlling mast-cell activation. The aim of the study is to investigate the efficacy~     of palmitoylethanolamide-polydatin combination on pain relief in symptomatic patients with~     endometriosis.~   "
91243|NCT02372890|"~     In head and neck squamous cell carcinoma (HNSCC), the presence of lymph node metastases in~     addition to free resection margins following surgical resection of the primary tumor is an~     important prognostic factor, and may impact planning of surgery as well as of radiotherapy.~     Until now, imaging modalities including PET/CT and MRI did not allow to exclude especially~     small lymph node metastases.~      Compared to standard whole-body PET/CT acquisition techniques, high-resolution (HR) head and~     neck PET/CT acquisitions promise improved detection of lymph node metastases in head and neck~     squamous cell carcinoma (HNSCC). This prospective study aims to determine the sensitivity and~     specificity of lymph node staging with HR FDG-PET/CT in HNSCC by correlating PET/CT with~     histopathology after neck dissection. HR PET/CT may have a relevant impact on the therapeutic~     concept, and the planning and dose prescription of radiotherapy.~   "
91244|NCT02372877|"~     The purpose of this study is to evaluate the performance of the AMICUS Red Blood Cell~     Exchange (RBCx) System (Exchange and Depletion/Exchange procedures) in patients with sickle~     cell disease.~   "
91280|NCT02372409|"~     By employing a combination of advanced MRI techniques and correlative serum biomarkers of~     blood brain barrier (BBB) disruption, the investigators plan to develop a powerful, first of~     its kind clinical algorithm in pediatrics whereby the investigators can measure and identify~     the window of maximal BBB disruption post MLA to 1) allow for an alternative to surgery in~     incompletely resected tumors, 2) allow for optimal chemotherapeutic dosing to achieve the~     greatest benefits and the least systemic side effects and 3) distinguish subsequent tumor~     progression from long-term MLA treatment effects. Preliminary data in adult imaging studies~     have shown that the BBB disruption lasts for several weeks following treatment before~     returning to a low baseline. This pilot therapeutic study will provide preliminary validation~     in pediatric patients.~   "
91245|NCT02372864|"~     Short Rationale: Risk-reducing salpingo-oophorectomy (RRSO) is a mainstay in preventing~     ovarian cancer in BRCA1/2 mutation carriers, as ovarian cancer screening is ineffective in~     detecting ovarian cancer in an early and curable stage. Women who underwent RRSO experienced~     bothersome menopausal symptoms and worsening of sexual functioning related to acute surgical~     menopause. Hormone replacement therapy (HRT) will mitigate some of the RRSO induced~     menopausal complaints, however it does not reduce the complaints to a premenopausal level and~     the sexual symptoms are not alleviated. Mindfulness interventions were found to improve~     sexual functioning and alleviate menopausal symptoms in various populations. It has not been~     investigated whether mindfulness-based stress reduction (MBSR) is effective in mitigating the~     RRSO-induced menopausal complaints in BRCA1/2 mutation carriers and if this effect is~     sustained over a longer period of time.~      Objective: To examine the effect of MBSR training on the menopause-specific quality of life~     in BRCA1/2 mutation carriers who experience RRSO-induced menopausal complaints.~      Study population: Female BRCA1/2 mutation carriers who were younger than 52 years at the time~     of RRSO reporting two or more moderate to severe menopause related complaints after~     undergoing RRSO.~      Study design: Prospective randomized controlled trial with a follow-up time of twelve months~     conducted at the University Medical Center Groningen (UMCG)~      Intervention: Eight-week MBSR training consisting of a weekly class of two and half hours and~     a full retreat day. Furthermore participants are asked to practice mindfulness exercises at~     home for 45 minutes, six days a week.~      Main study parameters/endpoints: Menopause specific quality of life score measured by the~     Menopause-specific quality of life questionnaire (MENQOL). Nature and extent of the burden~     and risks associated with participation, benefit and group relatedness: There are no risks~     associated with taking part in a MBSR training or filling out the questionnaires that will be~     used in this study. The content of the questionnaires concerns intimate matters and could be~     considered burdensome. A possible benefit for the participants of the MBSR training is that~     participants will be more able to cope with their complaints after RRSO. The group~     relatedness is reflected in the fact that RRSO is specifically performed in women with a~     hereditary risk of ovarian cancer such as BRCA1/2 mutation carriers.~   "
91246|NCT02372851|"~     The purpose of this study is to determine whether the use of a point-of-use water filtration~     technology can reduce the Arsenic content in drinking water and reduce the Arsenic body~     burden.~   "
91247|NCT02372838|"~     This study assesses the long-term functional outcomes of upper extremity long bone defects~     treated with the free fibula bone transfer.~   "
91248|NCT02372825|"~     Treatment of extensive traumatic acute bone defects or sequela in heel or ankle poses a~     formidable challenge for the reconstructive surgeon. These defects can be treated with the~     vascularized iliac crest transfer. The purpose of this study is to assess the reliability and~     the long-term outcomes of free iliac crest flap transfer for these indications.~   "
91249|NCT02372812|"~     A randomised controlled clinical trial to assess the effect of intraoperative dexamethasone~     on the 24 hour post operative pain scores of adult patients in Mulago hospital undergoing~     mastectomies, laparotomies and thyroidectomies. The adverse effects of dexamethasone at this~     dose were also assessed for.~   "
91250|NCT02372799|"~     The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone~     compared with placebo in pediatric outpatients (7-17 years of age) with major depressive~     disorder.~   "
91251|NCT02372786|"~     The purpose of this study is to compare the efficacy of 7% lidocaine / 7% tetracaine cream~     and 2,5% lidocaine / 2,5% prilocaine cream in reducing self-reported pain during a single~     laser procedure in the treatment of acne keloidalis nuchae and tattoo removal.~   "
91252|NCT02372773|"~     This study is being done to learn more about normal thinking and behavior, mild thinking and~     behavior problems, Frontotemporal Dementia and other forms of dementia in families in which~     one or more relatives have a mutation associated with Frontotemporal Dementia.~   "
91253|NCT02372760|"~     Bronchoscopy is a commonly performed procedure for inpatients to visualize the airways when~     indicated. It is routinely done for both diagnostic (to lavage and biopsy the respiratory~     tract) and therapeutic purposes (to relief an obstruction or remove foreign bodies). Given~     the possible side effects of cough of varying severity this procedure can be uncomfortable to~     patients, some would even shy away from having a bronchoscopy even when it's medically~     indicated.~      Recently a spray catheter was designed to deliver more uniform anesthesia to the airways as~     compared to the conventional way of injecting the anesthesia into the bronchoscopy working~     channel. The investigators aim to conduct this study with the hope of improving patient care,~     providing comfortable procedures, helping more patients opt in for bronchoscopy when~     indicated.~   "
91254|NCT02372747|"~     To compare the safety and feasibility of Delta-shaped anastomosis and Billroth II anastomosis~     after totally laparoscopic distal gastrectomy for gastric cancer(TLDG).~   "
91255|NCT02372734|"~     The research study will investigate the longitudinal cognitive outcomes in subjects admitted~     as children diagnosed with sepsis who may have had acute kidney injury. Each subject will be~     contacted 2-15 years after their incident admission in order to solicit responses to a~     functional and cognitive quality of life survey. Children admitted during the same time frame~     that did not have kidney injury will also be surveyed.~   "
91256|NCT02372721|"~     Sepsis is the most common cause of childhood death worldwide. Millions of children survive,~     but are left with impaired health. Sepsis-related Acute Kidney Injury (sAKI) is increasingly~     recognized as a significant factor associated with long-term mortality among different~     patient populations. Renal dysfunction and subsequent chronic kidney disease is implicated in~     the development of hypertension and cardiovascular disease. The investigators overall~     hypothesis is that, in the pediatric population, sepsis-related AKI will have unrecognized,~     long-term consequences with regard to kidney function, endothelial function, blood pressure~     control, and overall health.~   "
91257|NCT02372708|"~     To evaluate the therapeutic efficacy and the safety for the treatments on malignant melanoma~     by combining semiantigen dinitrophenyl (DNP) in situ immunotherapy and laser therapy, and~     carry out monitoring on related immunological parameters of the patients.~      72 patients with stage III (b or c) or stage IV skin (which could not be excised by~     operations) malignant melanoma were treated by combining simple semiantigen DNP in situ~     immunotherapy and laser therapy respectively. The changes in peripheral blood CD4+CD25+Treg~     regulatory T cells (Treg), CD8+T, CD4+ T effector cells, IL-10, TGF-β and other inhibitory~     cytokines of the patients were detected, the changes in anti-DNP IgG antibody titer was~     monitored, the relationship between delayed-type hypersensitivity (DTH) and survival was~     observed, and results of clinical follow-ups were also examined.~   "
91258|NCT02372695|"~     To provide evidence based prospectives of the potential benefit effects of paricalcitol, an~     analog of vitamin D, over the prevention / retardation of the progression of neoangiogenesis~     (vessels), atherosclerosis and vascular calcification.~   "
91281|NCT02372396|"~     The goal of this project is to refine an existing compassion meditation protocol for~     individuals with PTSD, to examine the safety and feasibility of this approach and to collect~     data to make initial estimates of efficacy.~   "
91259|NCT02372682|"~     Reliable methods of evaluating liver fibrosis using noninvasive techniques in the pediatric~     population are limited and inconclusive. Liver biopsy remains the gold standard; however, it~     requires sedation in pediatric patients, has a risk of hemorrhage, and provides unreliable~     results secondary to sampling error. Sonoelastography is a new method of evaluating liver~     disease that eliminates these pitfalls. There are 3 types of quantitative sonoelastography~     currently in use.~      Transient elastography is a non-imaging based technique used in adults to measure liver~     fibrosis in which a mechanical vibrator creates a low-frequency wave causing shear stress in~     the liver at a fixed depth. This technique does not work in small livers and, therefore, is~     not appropriate for pediatric patients.~      Acoustic Radiation Force Impulse Imaging (ARFI) and Shear Wave Imaging (SWE) use real-time~     ultrasonography and administer focused high-intensity, short-duration pulses to produce shear~     waves in the liver tissue. ARFI calculates the degree of tissue displacement and creates an~     elastogram or measurement of the stiffness of the sampled liver tissue without corresponding~     images. It is limited since only a small sample or region of interest (ROI) can be obtained,~     and it is unable to provide a corresponding elasticity map of the tissue.~      SWE is the newest elastography technique. It measures tiny displacements of tissue in a~     larger ROI with corresponding ultrasound images which provides a side by side image of the~     liver and color-coded elasticity map of the sampled tissue. Advantages include a larger ROI~     and simultaneous viewing of the selected region of interest which provides better anatomic~     detail with a corresponding color map of the tissue elasticity which may result in more~     accurate scoring of the stage of fibrosis.~      There are a few studies of ARFI in the pediatric population. Studies using SWE for evaluation~     of liver fibrosis are also few, and, all but one in adults. However, these studies have shown~     it to be an accurate method for liver fibrosis staging. Use of SWE in assessing liver~     fibrosis in pediatric patients may represent an accurate noninvasive alternative to liver~     biopsy in evaluating liver fibrosis as well as avoid the use of sedation.~   "
91260|NCT02372669|"~     The objective of this study is to evaluate whether the additional use of a nerve tube in~     primary microsurgical repair of traumatic sensory nerve lesions of the hand has an effect on~     convalescence and functional results.~   "
91261|NCT02372656|"~     This randomized controlled clinical trial compares efficacy of 1.2% simvastatin with 1%~     metformin in chronic periodontitis subjects.~   "
91262|NCT02372643|"~     Monocentric pilot interventional study. The aim of the study is to assess clitoral doppler~     ultrasonographic parameters in a population of sexually healthy volunteer women in order to~     obtain reference values. Psychobiological correlates of female sexual function will also be~     studied through hormonal testing and psychological evaluation.~   "
91263|NCT02372630|"~     This is a single center, prospective randomized double blind, parallel and placebo controlled~     study to evaluate oxidative stress and inflammation before and after treatment with~     linagliptin for 12 weeks. We will also, testing whether Linagliptin is an insulin sensitizer.~   "
91264|NCT02372617|"~     Prospective study enrolling patients with cerebral palsy and with subluxation of the hips >~     40% and acetabular dysplasia. The patients will be stratified according the degree of~     subluxation and age. The treatment protocol is composed by femur variation osteotomy and~     periacetabular osteotomy. Patients will be divided in two groups according the type of bone~     graft used at periacetabular osteotomy (autologous or ceramic).~   "
91265|NCT02372604|"~     Chronic Spontaneous Urticaria (CSU), defined by the persistence of daily or almost daily~     urticaria over 6 weeks, affects 0.5% to 1% of the general population. In more than half of~     the cases, it lasts more than 2 years. It can dramatically alter the quality of life, in~     particular sleep, and generates numerous consultations and hospitalizations, with an average~     annual cost per patient close to 2000 euros in Europe. The treatment is based on the~     validated 2nd generation anti-H1 antihistamines dosage of one tablet per day whose~     effectiveness is satisfactory, however about half the time. In cases of severe CSU refractory~     to treatment with anti-H1 licensed dosage, few therapeutic alternatives exist, still~     off-label: the monketulast, an anti-leukotriene, ciclosporine or methotrexate, as~     immunosuppressants. Various studies have shown the important benefit of an expensive anti-IgE~     biological: the omaluzimab. Several open studies have also suggested superior efficacy and~     good tolerability of anti-H1 in higher dosage (double, triple or quadruple) including~     levocetirizine.~      The off-label use of these high dosages of anti-H1 is growing very rapidly in France, tending~     to replace the use of anti-H1 first generation or substitution to another 2nd generation~     anti-H1 recommended by the French Society of Dermatology.~      This study, under the aegis of the Urticaria Group of the French Society of Dermatology,~     intends to compare the efficacy of levocetirizine 4 tablets/day versus 1 tablet/day in the~     treatment of CSU resistant to anti-H1 licensed dosage.~   "
91266|NCT02372591|"~     Pain is very common in persons with a history of addiction, but few studies have examined the~     best treatment of pain in this population. This is a study to determine the pain relief~     provided by intravenous hydromorphone (Dilaudid) or buprenorphine given to persons maintained~     on stable doses of methadone or buprenorphine who have chronic musculoskeletal pain.~     Experimental sessions will require overnight stays on a residential research unit. In these~     sessions, persons will be exposed to standard experimental pain techniques at baseline and~     then rate the relief (if any) provided by the study medication when exposed to the same~     techniques. Persons will be asked to participate in 3 sessions, each separated by at least 7~     days.~   "
91267|NCT02372578|"~     The purpose of this study is to assess analgesic efficacy of ASP3662 relative to placebo in~     subjects with painful diabetic peripheral neuropathy (PDPN) as well as assess the safety and~     tolerability of ASP3662 relative to placebo.~      The analgesic effect is evaluated by measuring percent responders, change in daily worst pain~     score, change in average daily pain score, Patient Global Impression of Change (PGIC) and~     Clinical Global Impression of Change (CGIC).~   "
91268|NCT02372565|"~     The purpose of this study is to evaluate the feasibility of a social media and~     text-message-delivered, Social Cognitive Theory-based, culturally relevant intervention~     designed to promote physical activity among African American women. An 8-week, 2-arm~     randomized trial will be implemented. Arm 1 will receive a culturally-relevant,~     technology-based physical activity intervention delivered via Facebook and text messages. Arm~     2 (Comparison Group) will receive a standard print-based physical activity promotion~     materials consisting of high quality physical activity promotion brochures produced by the~     American Heart Association.~   "
91269|NCT02372552|"~     This is a single centre, prospective, non-randomised pivotal clinical investigation to be~     undertaken at St Mark's Hospital, Harrow, UK.~   "
91282|NCT02372383|"~     The purpose of this study is to determine antimycobacterial drug pharmacokinetics (PK) and~     pharmacodynamics (PD) in patients with cystic fibrosis (CF) to improve treatment of~     nontuberculous mycobacterial (NTM) lung disease.~   "
91283|NCT02372370|"~     The study investigates the potential of a range of different physical pretreatments to~     enhance methyl aminolevulinate (MAL)-induced protoporphyrin IX (PpIX) in the skin prior to~     photodynamic therapy (PDT).~   "
91270|NCT02372539|"~     Dexamethasone is a steroid commonly used for the prevention of chemotherapy-induced nausea~     and vomiting (CINV). While effective, high dose dexamethasone is associated with numerous~     side effects, even when used for a short duration. One such effect is elevated blood glucose,~     or hyperglycemia. Current literature suggests increased risk of infection, poor wound~     healing, and increased mortality in non-cancer surgical patients with steroid-induced~     hyperglycemia. There is also evidence to support that elevations in blood glucose are~     associated with worsened outcomes in cancer patients. Much of this data comes from cancer~     patients that are treated in an inpatient setting where blood glucose is routinely checked.~     Limited data is available describing the fluctuations in blood glucose following~     dexamethasone administration in cancer patients being managed in an outpatient setting, such~     as the Anschutz Cancer Pavilion (ACP) Infusion Clinic. This study aims to characterize the~     effects dexamethasone has on blood glucose in cancer patients by utilizing Continuous Glucose~     Monitoring (CGM) devices. These devices are minimally invasive, are FDA approved, and can~     produce real-time data of blood glucose fluctuations over a course of 3-7 days. By inserting~     the devices under the skin of the abdomen, the investigators can evaluate the temporal~     relationship between glucose abnormalities and dexamethasone administration. Results from~     this study will not only increase the knowledge base of dexamethasone-induced hyperglycemia~     and identify patients at increased risk, but also allow future research to be conducted in~     order to determine if standard protocols can proactively minimize steroid-induced glucose~     fluctuations.~   "
91271|NCT02372526|"~     The purpose of this study is to determine the type of macronutrient (carbohydrate, lipid or~     protein) that most potently stimulates the endogen secretion of different gut hormones~     (primary outcome = Glucagon-Like peptide-1) in gastric bypass operated patients. The study~     also includes a comparison of the secretion of gut hormones after oral intake of lipid with~     or without a pancreatic lipase inhibitor.~   "
91272|NCT02372513|"~     Cholesteryl Ester Storage Disease (CESD) is an autosomal recessive lysosomal storage disorder~     (LSD) caused by mutations in the lysosomal acid lipase gene (LIPA) that markedly reduce~     lysosomal acid lipase (LAL) activity, leading to the accumulation of lipids, predominately~     cholesteryl esters and triglycerides, in various tissues and cell types. In the liver,~     accumulation of lipids leads to diffuse microvesicular steatosis, which progresses to~     fibrosis and ultimately, to micronodular cirrhosis. Patients typically present with~     hepatomegaly, liver dysfunction, hepatic failure and type II hyperlipidemia. Although~     hepatosteatosis is a typical finding, the liver biopsy diagnosis may be misclassified as~     non-alcoholic fatty liver disease, non-alcoholic steatohepatitis or cryptogenic liver~     disease. Biopsy and radiological findings are not considered diagnostic, but help to~     suspicion of CESD. The definitive diagnosis is based on deficient LAL activity and/or LIPA~     gene mutations.~      CESD is pan-ethnic, however, the disease incidence is unknown. The estimated incidence of the~     disease indicates that CESD should be largely underdiagnosed especially in European patients.~     Elevation of serum transaminases, and hepatomegaly are early indications of liver impairment.~     Therefore, CESD should be considered as a differential diagnosis in liver disease of unknown~     origin.~      To data, there is no study which evaluated the frequency of CESD in children with unexplained~     transaminase elevation and/or organomegaly and/or chronic liver disease. The aim of this~     prospective, multicenter and cross-sectional study is to investigate frequency of CESD in~     children with unexplained transaminase elevation and/or and/or chronic liver disease and to~     identify demographic and clinical features of CESD.~   "
91273|NCT02372500|"~     It is unknown whether post operative chewing gum will reduce post operative ileus. This study~     is a randomised controlled trial that will determine whether chewing gum three times a day~     following surgery will reduce post operative ileus. Time to passage of flatus will be used to~     determine that incidence of ileus.~   "
91274|NCT02372487|"~     The aim of this randomized trial is to detect whether or not the use of Sildenafil citrate~     therapy will increase the amniotic fluid volume expressed in term of amniotic fluid index~     measured via ultrasound for fetuses of pregnancies complicated by oligohydramnios, and to~     compare the outcomes of Sildenafil-treated pregnancies with similar pregnancies that will~     remain Sildenafil-naïve.~   "
91275|NCT02372474|"~     The purpose of this work is to evaluate the therapeutic potential of Autologous Mesenchymal~     sc (MSC) therapy in women suffering from POF.~   "
91276|NCT02372461|"~     The relative benefits and risks of antibiotic therapy in WHO defined fast breathing pneumonia~     in pre-school children in resource limited settings are controversial both at an individual~     and public health level. Most infections are viral or self-limiting and non-selective drug~     treatment has contributed to the global epidemic of antibiotic resistance. There is no high~     quality trial evidence in managing children with fast breathing in community settings and the~     WHO itself has called for evidence on which to update guidance. The investigators proposed~     non inferiority trial comparing standard antibiotic treatment with placebo in poor urban slum~     settings in South Asia to address this deficit.~   "
91277|NCT02372448|"~     Patients eligibility to targeted therapies relies on a molecular test performed on a tumor~     sample collected by biopsy. This invasive procedure is associated with a relative high risk~     of morbidity and requires the intervention of a costly and important technical platform.~     Thus, inoperable patients can be deprived from potentially more efficient therapies. A~     liquid biopsy of Circulating Tumor Cells (CTCs) present in the blood and their molecular~     characterization is an appealing alternative to meet an urgent need for these patients.~     Moreover no CTC-based molecular test is currently routinely available.~      The 5-year survival rate of patients with non-small cell lung carcinoma (NSCLC) is low.~     Recent reports demonstrated that the detection of an ALK rearrangement in the tumor tissue~     allows patients with late-stages NSCLC to benefit from crizotinib treatment.~      However, 1) the detection of an ALK rearrangement is currently performed on small biopsies or~     fine-needle aspirates and can be hindered by the limited tissue quantities available. Tumor~     tissue is difficult to obtain in patients with advanced/metastatic lung cancer for whom~     surgery is rarely a component of treatment. Finding alternative and more effective means of~     diagnosing an ALK rearrangement are critical issues for identifying patients who may benefit~     from treatment with crizotinib; 2) some patients develop resistance to crizotinib due to de~     novo ALK mutations.~      In this setting, circulating tumor cells (CTCs), which have been shown to be detectable by~     ISET (Isolation by Size of Epithelial Tumor Cells) method in 80% to 100 % of late stages lung~     cancer patients represent a non-invasive and easily accessible source of tumor material for~     assessing ALK rearrangement and escaping mutations in a kinetic manner. The ISET method was~     first published in 2000 and several independent teams have now established its high~     sensitivity and specificity of ISET for NSCLC. With ISET, specificity can be achieved using~     the same methods and criteria used by cytopathologists to diagnose solid tumors.~      The high sensitivity and specificity of ISET are two essential starting points for the~     feasibility of this present project. Low-throughput molecular characterization of CTCs~     isolated by ISET has also been achieved. The remaining challenge consists in developing~     high-throughput ISET-based molecular tests for personalized medicine that are transferable to~     the clinics.~      The Team 1 at the CHU de Nice and the Team 2 at the Gustave Roussy Institute have~     demonstrated that the detection of an ALK rearrangement in CTC isolated by ISET is feasible~     and consistent with results obtained in corresponding tumor tissues. In this context, the aim~     of this project is to obtain 1) a definitive prospective clinical validation of the use of~     CTC as an alternative to tumor tissue for ALK analysis-based patients stratification; 2) a~     proof that escaping mutations can be detected early by kinetic analysis of CTC in patients~     treated by crizotinib. ALK rearrangement will be prospectively investigated in CTCs isolated~     by ISET at diagnosis and during follow up from patients with stage IIIb/IV lung cancer and de~     novo mutations will be searched in patients with resistance to crizotinib. This study will~     provide both clinical and economic benefit to targeted treatment of patients with advanced~     lung cancer.~      This project is strongly original as no CTC-based ALK rearrangement test has been~     independently validated up to now with clinical samples. The development of non-invasive~     theranostic test through the genetic analysis of CTCs is a clinically relevant goal for~     non-invasive stratification of cancer patients, avoiding morbidity related to lung biopsy and~     surgery. It would allow determining patient's eligibility to targeted therapies on a blood~     sample analysis. CTC-based ALK test could be useful to guide the choice of ALK targeted~     therapy in patients with lung cancer. Furthermore, developing biomarkers based on CTCs~     analysis would open the way to the non-invasive follow up of aggressive cancers, early~     detection of mutations associated with resistance to targeted therapies and tailoring~     treatment to a real time analysis of the evolving tumor cell populations. This test is~     expected to markedly improve patients' quality of life avoiding invasive diagnostic~     procedures.~   "
91278|NCT02372435|"~     Patients with hip, knee and shoulder PJI, will be treated with a two-stage exchange Revision.~      Patients will be randomized into 2 groups: the experimental Group will get a reimplantation~     after a short interval (2-3 weeks) while the control Group after a long standard interval.~      Primary objective of the study is Infection outcome. The infection-free status is defined~     as absence of clinical (e.g. no fistula), laboratory (e.g. normal C-reactive protein) and~     radiological signs of infection (e.g. no septic loosening).~      Secondary objective is Functional outcome.The functional assessment will be performed using~     joint-specific scores (HARRIS HIP SCORE, CONSTANT SHOULDER SCORE, KNEE SOCIETY SCORE, OXFORD~     HIP SCORE, OXFORD KNEE SCORE, QUICK DASH SCORE) involving the range of motion (ROM), patient~     mobility / independency in daily life, subjective evaluation of pain using a visual analog~     pain scale (1-10 points) and life-quality evaluation (EQ5D5L score).~   "
91279|NCT02372422|"~     The purpose of this study is to determine if the use of routine transvaginal cervical length~     ultrasound can be used to prevent preterm deliveries in twin gestations.~   "
91284|NCT02372357|"~     A new prophylactic posaconazole dosing regimen of 120mg/m² tid is evaluated pharmacologically~     in children 13 years and younger, suffering from a hematologic malignancy.~   "
91285|NCT02372344|"~     The purpose of this study is to assess the effect of food timing on pharmacokinetics (PK) of~     AZD0585 and the effect of food timing on tolerability and safety of AZD0585 in healthy male~     Japanese subjects.~   "
91286|NCT02372331|"~     Enhanced Recovery After Surgery (ERAS) is not the program that aim to reduce postoperative~     hospital stay, but the multimodal strategies that aim to attenuate the loss of, and improve~     the restoration of,functional capacity after surgery on evidence-based medicine. The benefits~     of ERAS is proved in many surgical procedures, such as upper gastrointestinal surgery and~     colorectal surgery. However, pancreaticoduodenectomy (PD, Whipple's operation) is still one~     of most complex abdominal surgery, and there is no evidence that ERAS is beneficial on PD.~      This study investigate the clinical effectiveness of ERAS on PD.~   "
91287|NCT02372318|"~     The aim of this study is to use functional Magnetic Resonance Imaging (fMRI) to measure~     neural reactivity to alcohol-related and emotional cues in alcohol dependent subjects~     following a single dose of the opioid receptor modulator nalmefene. The study will be done in~     a cross over design with nalmefene versus placebo.~   "
91288|NCT02372305|"~     FlexHD and Alloderm are two common products used in breast reconstruction to hold tissue~     expanders and implants in place. There have been few chart review studies comparing outcomes~     between the two materials in breast reconstruction. These studies have determined there is no~     difference in complication rates between the two materials. However, there have never been~     any active studies to date. This study will serve as a randomized controlled trial comparing~     FlexHD and Alloderm. Several outcomes will be measured based off of inclusion and exclusion~     criteria to determine if either product is more suitable for use in breast reconstruction.~     This will be performed by randomly assigning patients to receive either FlexHD or Alloderm.~     Designated outcomes will be followed closely postoperatively. Outcomes will be statistically~     analyzed to determine complication rates between FlexHD and Alloderm and thus which product~     is better to use in breast reconstruction.~   "
91289|NCT02372292|"~     Although the traditional determinant of renal dysfunction in heart failure was suggested as~     decreased cardiac output and renal hypo perfusion, recent studies have demonstrated the~     association of persistent systemic venous congestion and kidney dysfunction. Relief of the~     congestion has demonstrated to improve renal functions in decompensated heart failure. The~     current trial was set up to investigate the changes of renal venous impedance and renal~     arteriolar resistivity indices with diuretic therapy, in patients with congestive renal~     failure. The investigators asked whether measurement of renal venous impedance index or renal~     arteriolar resistivity index can guide the practice of diuretic therapy.~   "
91290|NCT02372279|"~     In a conventional in vitro fertilization (IVF) cycle, daily microscopic observation of~     embryos outside the incubator to assess their morphology and establish a selection process is~     performed. In this way it is possible to know which embryo or embryos have greater~     implantantion capacity and will be transferred to the uterus to obtain a viable pregnancy.~     However, these observations can produce deleterious effects on embryo development due to~     changes in temperature, pH and osmolarity of the culture media, as well as a negative effect~     of direct light microscope for observation. This project aims to test the hypothesis that~     non-embryonic observation produces a beneficial effect on embryo quality until day 5 of~     development (blastocyst stage) and, therefore, on rates of implantation and ongoing~     gestation, compared with the conventional protocol of observations under the inverted~     microscope on days two, three and five of development.~   "
91291|NCT02372266|"~     To determine the effect of a policy of early maternal-newborn infant discharge (12-24 hours)~     with a home visit on admission to the Level II/III nursery and hospital admissions and~     readmissions.~   "
91292|NCT02372253|"~     The overall purpose of this trial is to assess the efficacy and safety of using oral~     verapamil in subjects with recent onset T1D in order to downregulate TXNIP and enhance the~     patients' endogenous beta cell mass and insulin production. The objectives are therefore to~     assess parameters of beta cell survival (including new biomarkers), insulin production and~     glucose control and the feasibility of this approach and thereby provide the basis for~     future, larger/expanded, longer-term verapamil studies and the off-label use of this approved~     drug for T1D.~   "
91293|NCT02372240|"~     This is a phase 1/2 single arm study to determine the safety and efficacy of VLX1570 IV~     infusion administered with low dose dexamethasone in patients with relapsed or relapsed and~     refractory multiple myeloma.~   "
91294|NCT02372227|"~     The purpose of this study is to evaluate rising dose levels of VS-5584 administered in~     combination with a fixed dose of VS-6063 in subjects with relapsed malignant mesothelioma to~     determine a recommended Phase 2 dose (RP2D) for further development of this combination in~     this indication.~   "
91295|NCT02372214|"~     The purpose of this study is to produce a patient-specific simulator for endovascular~     infra-renal aneurysm repair training and than analyze the effect of simulator training on the~     performance of vascular surgery residents.~   "
91296|NCT02372201|"~     Consequences of Colon Hydrotherapy plus probiotic intervention on composition of GI~     microbiota and well being are analysed in subjects claiming GI inconveniences due to~     Irritable Bowel Syndrome or food intolerances.~   "
91297|NCT02372188|"~     The purpose of this study is to elucidate whether bitter taste induced by the bitter compound~     caffeine and the reduction of bitter taste by addition of the bitter masking compound~     Homoeriodictyol sodium salt (HED) influence gastric acid secretion, subjective feelings of~     hunger, ad libitum food intake and satiating hormones in healthy volunteers.~   "
91298|NCT02372175|"~     To evaluate the effectiveness of candidate dengue vaccine formulations, it is prudent to~     develop an appropriate challenge model. To this end, this first-in-human study will examine~     the safety and effectiveness of the Dengue 1 Live Virus Human Challenge (DENV-1-LVHC) product~     and assess the ability of this virus strain to elicit an uncomplicated dengue-like illness.~   "
91313|NCT02371967|"~     This prospective, observational, cohort study is designed to assess the effectiveness and~     safety outcomes of vismodegib and to assess actual day-to-day disease and participant~     management by the physician.~   "
91314|NCT02371954|"~     The study is a randomized pilot trial of a health promotion intervention in the prevention of~     anxiety and depression in older Hispanics.~   "
91315|NCT02371941|"~     This is a randomized, double-blind, placebo-controlled study of oral cromolyn sodium when~     made into a viscous preparation for the treatment of eosinophilic esophagitis.~   "
91558|NCT02368756|"~     The Endurance 2 Trial is to determine the need for ongoing intravitreal aflibercept~     injections for patients with diabetic macular edema who have previously completed the VISTA~     study.~   "
91299|NCT02372162|"~     This single center, open-label, uncontrolled, non-randomized observational study in patients~     with advanced HCC. The patients qualify either to a local treatment with transarterial~     chemoembolization (TACE) or to a systemic treatment with the multikinase inhibitor sorafenib.~     The aim of this feasibility study is to get a comprehensive image and molecular fingerprint~     of individual tumors, with the intention to govern therapy decisions. Furthermore, to improve~     the care of patients that get progressive disease under treatment, the investigators have to~     improve the investigators understanding of the development of therapy resistance, which will~     improve patient care at the time point of progressive disease. Therefore, the data of 20~     patients in each group will be used to identify molecular and / or image patterns, that can~     be used to predict treatment responses and thus govern an optimized individual cancer~     treatment for patients with advanced HCC.~   "
91300|NCT02372149|"~     The purpose of this study is to determine whether intravenous immunoglobulin (IVIg) is an~     effective intervention for patients with diabetes, peripheral neuropathy, and demyelination~     on nerve conduction studies. All patients will receive both IVIg and placebo for 3 months~     each, with a 3 month washout period in between.~   "
91301|NCT02372136|"~     In preterm infants fed human milk, milk needs to be fortified to meet nutrient~     recommendations. Fortification can be 1) standard, 2) individualized (adjusted based on daily~     human milk nutrient analysis and milk volume), or 3) optimized (adjusted based on growth rate~     and serum analyses).~      The first specific aim will determine whether individualized and optimized nutrition during~     hospitalization results in improved growth in the neonatal intensive care unit (NICU) in~     extremely low gestational age (GA) neonates (ELGANs, <29 weeks) and in small for GA (SGA,~     birth weight <10th percentile for GA) preterm infants compared with optimized nutrition.~      The second specific aim will determine whether individualized and optimized nutrition in the~     NICU improves neurodevelopmental outcomes (acquisition of development milestones) and reduces~     the risk of disproportionate growth (i.e., excess fat) in the NICU and findings suggestive of~     metabolic syndrome in the first 3 years of life.~   "
91302|NCT02372123|"~     The aim of this study is to investigate the effect of connective tissue manipulation on pain~     threshold in women with primary dysmenorrhoea. According to literature, there are studies~     that measure the pain threshold. But there is no randomized controlled trial which explore~     the short and long-term effects of connective tissue manipulation on primary dysmenorrhoea.~     Hypothesis of this study is that connective tissue manipulation increases pain threshold and~     decreases severity of pain in women suffer with primary dysmenorrhoea.~   "
91303|NCT02372110|"~     The proposed study aims to investigate experimentally anxiety sensitivity and physiologic~     sensations associated with anxiety using a paradigm combining hydrocortisone, caffeine, and a~     set of social stress challenges. Following informed consent, participants will be instructed~     to ingest either 400 milligrams of caffeine (an amount of caffeine roughly equivalent to that~     in two 8 oz. cups of brewed coffee from Starbucks), and 20 milligrams of hydrocortisone or~     two placebo capsules via stratified, random assignment. Physiologic and self-reported~     measures of stress and anxiety will be taken.~   "
91304|NCT02372097|"~     The purpose of this study is to investigate the bioequivalence of 2 tablets of SYR-472 25~     milligram (mg) and 1 tablet of SYR-472 50 mg administered to healthy adult males.~   "
91305|NCT02372084|"~     To assess the pharmacokinetics of a single oral dose of osilodrostat (LCI699) 30 mg in~     subjects with mild, moderate and severe hepatic impairment compared with subjects with normal~     hepatic function.~   "
91306|NCT02372071|"~     The primary objective of this study is to define the performance evaluation of BiliCare TcB~     device to the gold standard bilirubin tests.~   "
91307|NCT02372058|"~     The primary objective of this study is to define the performance evaluation of BiliCare TcB~     device to the gold standard bilirubin tests.~   "
91308|NCT02372032|"~     Lumbar disc herniation (LDH) is a common pathological process leading to spinal surgery. Open~     discectomy used to be a widespread procedure for surgical treatment for symptomatic LDH.~     Currently, several minimal invasive surgeries have been uesd widely. Percutaneous lumbar~     discectomy(PLD) and ozone therapy are two widely used minimal invasive treatment, and ozone~     therapy combined other minimally invasive treatment could improve other minimally invasive~     treatment's clinical effectiveness. The effectiveness of which has been proved to be~     comparable to conventional open discectomy.~      In this study, a single-blind randomized controlled trial will be performed to evaluate the~     effectiveness of two minimal invasive discectomy, percutaneous lumbar discectomy combined~     with ozone and percutaneous lumbar discectomy, for the treatment of symptomatic LDH.~      Two groups of patients will be investigated; 1) patients diagnosed with lumbar disc~     herniation undergoing PLD combined with ozone, and 2) patients diagnosed with lumbar disc~     herniation undergoing PLD.~      The primary endpoints of the study will be changes in in pain and functional status by the~     Visual Analog Scale (VAS) and functional status as measured by Oswestry Low Back Disability~     Questionnaire (Oswestry Disability Index,ODI) and Japanese Orthopaedic Association (JOA) as~     measured at pre- and post-operation, 1 month, 3 months, 6 months. Secondary outcomes include~     response evaluation by MacNab response evaluation criteria as measured at pre- and~     post-operation, 1 month, 3 months, 6 months. Treatment effect is defined as the difference in~     the mean change from baseline between the two groups.~      For the first time,the results of this trial will provide scientific evidence as to the~     relative effectiveness of PLD combined with ozone versus PLD for minimal invasive surgical~     treatment for symptomatic lumbar disc herniation.~   "
91309|NCT02372019|"~     The purpose of this study is to determine whether briefly reactivating a fear memory 20~     minutes prior to administering a social anxiety treatment will enhance the durability of~     treatment effects.~   "
91310|NCT02372006|"~     Open-label, dose escalation, monotherapy, basket trial with biomarker specific MTD expansion~     cohort/Phase II part.~      The trial will consist of 2 parts:~        1. Dose finding part to determine the MTD~        2. Biomarker specific MTD expansion cohort/Phase II part to assess clinical anti-tumour~          activity in included tumour types~   "
91311|NCT02371993|"~     Asthma in the elderly is poorly understood, as most studies have not included this patient~     group. In a previous study of adults with asthma, choline supplementation had a positive~     effect on asthma symptoms and allowed to decrease asthma pharmacologic treatment. The present~     study is a randomized, double-blind, placebo-controlled, cross-over study of choline~     supplementation. The investigators will study the effect of choline 650 mg taken orally twice~     daily x 6 weeks versus placebo on asthma symptom scores (Asthma Control Test) and spirometric~     values (FEV1, FEV1/FVC, FEF25-75%). The investigators will also look at the effect of choline~     supplementation on peripheral blood eosinophils, serum immunoglobulin E (IgE) and~     homocysteine levels.~   "
91312|NCT02371980|"~     The purpose of this study is to evaluate the efficacy of vortioxetine (5, 10, and 20 mg)~     versus placebo during the first 28 weeks of the 32-week double-blind treatment period in the~     prevention of relapse in participants with major depressive disorder (MDD) who responded to~     acute treatment with vortioxetine 10 mg.~   "
91316|NCT02371928|"~     This study is designed to investigate the efficacy and safety of a supervised neuromuscular~     exercise program versus a standard home exercise program for patients with post-traumatic~     symptomatic anterior shoulder instability.~      Participants with at least one week of symptom duration are randomly assigned to either a~     12-week structured, supervised Shoulder Instability Neuromuscular EXercise (SINEX) program~     versus a standard HOMe EXercise (HOMEX) program.~      The H1-hypothesis is that the SINEX program results in a greater increase in quality of life~     and physical function than the HOMEX program at the primary endpoint at three months~     follow-up from baseline~   "
91317|NCT02371915|"~     This project will be conducted in two phases. Phase 1: RA patients will be recruited to~     participate in five repeated examinations occurring in one day to compare between and within~     specialties, ensuring reasonable equivalency of examination findings. Phase 2: RA patients~     living > 100 km from Saskatoon will be randomized to the intervention or control group, with~     both groups having three follow-up appointments in 3-month intervals. The intervention group~     will be evaluated by a physiotherapist supported by a rheumatologist through~     videoconferencing, while the control group will continue to travel to Saskatoon for follow-up~     care.~   "
91318|NCT02371902|"~     Chronic lateral epicondylitis is usually managed conservatively. The purpose of this~     single-blinded, randomized, controlled study is to compare the clinical therapeutic effects~     of extracorporeal shock wave therapy (ESWT) in comparison with cryoultrasound (Cryo-US)~     therapy in chronic lateral epicondylitis (LE) during a period of 12 months.~   "
91319|NCT02371889|"~     The purpose of this study is to advance the effort to develop personalized pharmacotherapy~     for alcohol use disorders (AUDs). The investigators propose to conduct a 12-week,~     prospective, randomized clinical trial of the moderating effect of rs2832407 on the efficacy~     of TOP in reducing heavy drinking (HD) in 200 individuals of European descent with DSM-5 AUD.~     The investigators will stratify the randomization on genotype and oversample rs2832407*C~     homozygotes, the most TOP-responsive genotype, to ensure comparable numbers of patients in~     the four medication x genotype groups. The investigators will use daily data collection to~     examine changes in relevant process variables (e.g., alcohol expectancies) and their~     interaction with genotype and medication group as predictors of HD. The proposed study is~     innovative in that it will be the first prospective test of a pharmacogenetic hypothesis~     involving TOP; it will use daily reports to examine expectancies and how they interact with~     medication and genotype to predict HD; and it will enroll DSM-5 AUD patients whose goal is~     either to reduce or stop drinking, which will increase the study's external validity.~   "
91320|NCT02371876|"~     The purpose of this study was to determine if untrained subjects with diabetes can operate~     the Investigational ONYX PLUS Blood Glucose Monitoring System (BGMS) and obtain valid glucose~     results.~   "
91321|NCT02371863|"~     Surgical treatment is the only approach with potentially defined clinical success for organic~     mitral valve (MV) regurgitation. Recurrent or persistent complaints after initial successful~     MV repair is a clinical challenge in current practice. Especially when echo parameters at~     rest are within or near normal ranges and patients presenting disproportionately symptomatic~     in relation to the observed results. However, while MV regurgitation is a hemodynamic~     disease, currently used 2-dimensional (2D) transthoracic echocardiography (TTE) at rest lacks~     information about hemodynamic changes. Physical stress echocardiography is a promising~     technique to complement nowadays rest TTE in order to improve interpretation of hemodynamic~     changes. However, normal values for exercise echo are lacking in this postoperative patients~     cohort. A prospective, observational trial to determine normal values in stress~     echocardiographic parameters in asymptomatic patients after successful MV repair for organic~     MV regurgitation, is therefore highly needed.~      Purpose of the SEP- study is to determine normal values in stress echocardiographic~     parameters in asymptomatic patients at least 6 months after successful MV repair for organic~     MV regurgitation. These normal values for stress echo are of utmost importance to correctly~     and accurate interpret stress echo results during postoperative follow-up and to improve~     clinical decision making in patients post MV repair.~   "
91322|NCT02371850|"~     This is a single-dose, Open-label, Non-Randomized, 2-way Crossover Bioequivalence Study to~     compare nicotine release after heating of a brand name (Nicoderm CQ) and generic (Aveva skin~     patch) nicotine skin patches in adult smokers.~   "
91323|NCT02371837|"~     The intervention will consist in a 6 week of pilates practice in older population to check~     the prevention of fall effectiveness.~   "
91324|NCT02371824|"~     DCE-MRI were performed in sixty adults (hips and lumbar spine). For each region of interest~     studied, the investigators determined the morphology of each time-concentration curve (TCC)~     and calculated semi-quantitative and pharmacokinetic parameters: initial slope (IS), area~     under the curve (AUC), time to peak (TTP), Ktrans, Kep and Ve. Clinical data were collected~     anamnestically.~   "
91325|NCT02371811|"~     The investigators use v care during abdominal hysterectomy and evaluate its effect on~     duration of operation time, surgical complications and vaginal length.~   "
91326|NCT02371798|"~     The purpose of this research study is to see if magnetic resonance imaging (MRI) with a~     double dose of contrast, or dye, and delayed imaging with MRI can help to diagnose Meniere~     Disease.~   "
91327|NCT02371785|"~     This study evaluates the performance of the CorPath 200 System to deliver guide wires and~     balloons to blockages in the arteries of the leg.~   "
91328|NCT02371772|"~     The aim of the study was to compare self-management of anticoagulant treatment with~     conventional anticoagulant treatment in Norway.~   "
91329|NCT02371759|"~     The purpose of this study is to determine whether 2% lidocaine (L) + clonidine (C) (15~     mcg/ml) as a vasoconstrictor achieves efficient (equal or better parameters of intraoral~     local anesthesia in comparison to 2% lidocaine + epinephrine (E) (1:80 000)) and safe (stable~     cardiovascular parameters - systolic, diastolic, mean blood pressure and heart rate)~     intraoral local anesthesia in patients with Diabetes mellitus type 2.~   "
91330|NCT02371746|"~     This is a multiple cohort study that will evaluate the safety and efficacy of ENV515~     travoprost XR in patients with open-angle glaucoma or ocular hypertension.~   "
91751|NCT02366208|"~     This trial is to assess the efficacy and safety of Polyethylene Glycol thymosin alpha1~     (PEG-Tα1), a new long immunomodulator (Category 1.1 of Chemical Drugs) being developed from~     Hansoh Pharmaceutical of China, in combination with adefovir in HBeAg-positive patients with~     chronic hepatitis B.~   "
91334|NCT02371694|"~     Background: Based on international evidence, current management of people with T1DM on~     intensive insulin therapy (IIT) use algorithms based on the meal carbohydrate content (MCC)~     to calculate the prandial insulin dose. Typically, these calculations do not take into~     account the protein or fat content of the meal. There is a lack of clinical advice for~     optimal management of high protein/fat meals due to a paucity of evidence regarding the~     impact of protein/fat on glycaemic control.~      Objective: To determine the mean glucose excursion from fasting (measured by continuous~     glucose monitoring, CGMS) at each 30 minute interval over the 8 hour postprandial period for~     each test condition. Protein effects will be looked at in a separate parallel study in~     Australia.~      Hypothesis: The fat content of a meal will cause a dose-response change in the postprandial~     glucose concentration in children with T1DM.~      Research Design and Methods: Randomised cross-over study involving thirty patients. Inclusion~     criteria: T1DM >1 year, aged 8-18 years, with HbA1c <8% and BMI <91st centile, on intensive~     insulin therapy. Participants will be given a test meal on 6 consecutive nights in random~     order; 4 test meals varying in fat content, and one 20g carbohydrate test meal with zero fat~     given as control meal. A CGMS will be used to assess glucose responses at 5 minute intervals~     for 8 hours after test meal consumption. The relationship between the fat loads in the test~     meals and the mean change in postprandial glucose concentration will be analysed and~     described.~      Conclusions: This study will determine whether fat causes dose dependent response in glucose~     concentrations leading to refining the guidelines and possible adjustment of insulin doses~     for the fat content of a meal.~   "
91335|NCT02371681|"~     Background:~      - Tuberculosis (TB) is a lung infection caused by bacteria. When people with TB cough, they~     may spread these bacteria. Researchers are looking for new TB medicines. They want to find a~     faster way to tell if a drug might combat TB.~      Objective:~      - To learn the effect of different anti-TB drugs on microbiological, radiographic and~     immunologic markers in people with TB.~      Eligibility:~      - Adults age 18-65 who weigh 30-90 kg and have common TB bacteria that can be treated with~     common TB medicines.~      Design:~        -  Participants will be admitted to the hospital for screening. They will have medical~          history, physical exam, and chest radiograph. They will give blood, urine, and sputum~          samples.~        -  Participants will be put in 1 of 8 groups.~        -  Participants will get one or a combination of TB medicines daily for about 14 days.~        -  Each day, participants:~        -  Will discuss side effects.~        -  May have a physical exam.~        -  Will spit mucus into a cup. They may breathe in saline water through a nebulizer to make~          them cough.~        -  Participants will have blood taken 3-4 times during the study~        -  Participants will have 2-3 Fluorodeoxyglucose Positron Emission Tomography/Computed~          Tomography (FDG-PET/CT) scans. FDG is a radioactive sugar molecule which helps measure~          TB disease in the lungs. It will be injected into a vein. Participants will lie in a~          scanner that takes pictures.~        -  Around study day 14, participants will leave the hospital. They will be referred to a~          local TB clinic. There they will get the standard 4 TB medicines. Those in group 8 will~          already be on these medicines and will have another FDG-PET/CT on day 28.~        -  Participants will be in the study for up to 28 days.~   "
91336|NCT02371668|"~     Background:~      - Researchers want to see if a new drug reduces flu disease in people treated with this drug~     versus a placebo. The drug has an antibody that may help the immune system fight the flu.~     Placebo is only sugar and water. All participants will get the flu virus. They may or may not~     develop flu symptoms.~      Objective:~      - To see if the drug CR6261 reduces flu disease in people treated with this drug versus a~     placebo.~      Eligibility:~      - Healthy nonsmokers ages 18 45.~      Design:~        -  Participants will be screened under a separate protocol.~        -  Participants must use contraception or abstinence for several weeks before and after the~          study. They must have no alcohol for 1 day before each visit. Any medicine must be~          approved by the study doctor until after follow-up.~        -  Participants will stay in a hospital isolation unit for at least 10 days.~        -  They will have:~        -  Medical history~        -  Physical exam~        -  Blood and urine tests~        -  Heart and lung test~        -  Tests for drugs and alcohol~        -  Throughout their stay, participants will:~        -  Be closely watched by a medical team~        -  Have nasal washes and swabs several times a day~        -  Participants will have the flu virus sprayed in each nostril.~        -  The next day, participants will get either study drug or placebo through a soft plastic~          tube placed in a vein by needle. It will take 2 hours. They will not know which they~          get.~        -  Participants can go home after 10 days if they test negative for the flu 2 days in a~          row.~        -  Participants will have daily questionnaires at home and 2 follow-up visits over 2~          months.~   "
91337|NCT02371655|"~     The aim of this study is to compare a new regimen of reduced bowel preparation that does not~     include low fiber diet with another reduced bowel preparation including low-fiber diet.~   "
91338|NCT02371642|"~     The purpose of this project is to evaluate the utility of left ventricular strain as part of~     the assessment of patients in the emergency department with acute heart failure (HF). The~     central hypothesis of the investigation is that left ventricular strain will prove to be a~     treatment response variable in patients with acute HF. Patients who are being treated for~     acute HF with intravenous (IV) vasoactive medications (diuretics, vasodilators, inotropes)~     will be eligible for enrollment. Patients who give written consent will receive a focused~     bedside echocardiogram within 30 minutes of the initiation of therapy for acute HF. Images~     that are captured during this echocardiogram will be interpreted by a blinded cardiologist~     offline. 23 hours after this initial focused echocardiogram a member of the study team will~     perform a follow-up focused echocardiogram, capturing the same images that will then be~     interpreted by a blinded cardiologist offline.~      Offline analysis will be performed using a proprietary software package from General Electric~     called Automated Function Imaging (AFI). The AFI software will be used to calculate~     longitudinal strain of the left ventricle (LV). Regional and global strain values will be~     calculated for each focused echocardiogram for each subject. It is our hypothesis that LV~     strain will demonstrate improvements from the initial echocardiogram to the follow-up~     echocardiogram, unlike other echocardiographic indices in HF such as LV ejection fraction.~   "
91752|NCT02366195|"~     The study is a phase 2, multi centered, single arm study designed to evaluate the correlation~     between CD8+ cell density and objective response rate in subjects with unresected stage IIIB~     to IVM1c melanoma. This study will also evaluate the safety and tolerability profile of~     talimogene laherparepvec.~   "
91339|NCT02371629|"~     This study is a post-authorization commitment to the European Medicines Agency (EMA). The~     study serves to determine whether the treatment of patients with stable, symptomatic Chronic~     Obstructive Pulmonary Disease (COPD) with the investigational drug NVA237 is efficient and~     safe. The efficacy and safety of the drug will be tested for twice daily dosing against once~     daily dosing. The primary criterion to assess efficacy will be the trough FEV1 (defined as~     mean evaluation at 23 h 15 min and 23 h 45 min post dose) measurements of patients who have~     been treated for 12 weeks with NVA237 b.i.d versus those that have received NVA237 o.d.for 12~     weeks.~   "
91340|NCT02371616|"~     An 8 week clinical study to evaluate the ability of an experimental dentifrice containing~     calcium sodium phosphosilicate and sodium fluoride to provide relief from dentine~     hypersensitivity compared to a marketed dentifrice containing calcium sodium phosphosilicate~     and sodium monofluorophosphate.~   "
91341|NCT02371603|"~     This study will be a two-part with an open-label, single oral dose, two-way crossover study~     design. Part A and Part B of the study are independent and may be conducted in parallel. The~     Part A of the study will assess the effect of an oral dose of GSK1278863 on the~     pharmacokinetics of a CYP2C8 (pioglitazone) and OATP1B1 (rosuvastatin) probe substrate in~     order to determine the potential for clinically-significant drug interactions with CYP2C8 and~     OATP1B1 substrates. The Part B of the study will assess the effect of a weak CYP2C8 inhibitor~     (trimethoprim) on the pharmacokinetics of GSK1278863 and its six predominant metabolites.~     Part A will be conducted in approximately 30 healthy subjects, having a randomized study~     design. There will be approximate 7-day washout period between each dosing period. Part B~     will be conducted in approximately 20 healthy subjects, having single sequence study design.~     Follow up will be conducted within 7 to 10 days after the last dose in both Part A and B. The~     total duration of a subject's involvement in the part A of the study will be approximately 8~     weeks (Screening to Follow-up) and in part B will be approximately 7 weeks (Screening to~     Follow-up).~   "
91342|NCT02371590|"~     This is phase 1/2 study for patients with CLL or (SLL) who have not been previously treated.~     This study will evaluate whether obinutuzumab and lenalidomide is safe and tolerable in this~     setting and induce complete clinical responses.~   "
91343|NCT02371577|"~     This is phase 2 study of the immunomodulatory drug, lenalidomide, to evaluate potential~     beneficial effects on the immune system of patients with chronic lymphocytic leukemia (CLL)~     and CLL-associated immunodeficiency. 17 patients will be enrolled with CLL, small lymphocytic~     lymphoma (SLL), or monoclonal B-cell lymphocytosis (MBL), and measurable immune compromise,~     but not an iwCLL indication for CLL therapy (ie non-progressive disease).~   "
91344|NCT02371564|"~     Acute exacerbation of chronic obstructive pulmonary disease (COPD) is associated with poor~     outcome, especially when intubation is required, thus underlining the importance of~     optimizing non-invasive ventilatory support to avoid intubation. Practically, because of~     treatment intolerance, non-invasive ventilation (NIV) cannot be administered 24-hour a day~     for a long period of time and alternative solutions must be found to deliver oxygen as~     efficiently as possible to allow NIV interruptions. High flow humidified oxygen therapy~     (HFHO) consists of delivering a high-flow (15-60 L/minute) heated air-oxygen mixture (FIO2~     21-100%) through a dedicated nasal cannula and can be interesting in this context. This well~     tolerated technique improves oxygenation and decreases respiratory rate and dyspnea in~     patients suffering from acute hypoxemic respiratory failure. In chronic COPD patients, using~     HFHO can decrease respiratory rate and PaCO2. In COPD exacerbation, using HFHO can~     conceptually be interesting. First, the high air-oxygen flow delivered well matches the~     patient's inspiratory demand and should decrease the work of breathing. Second, as during~     HFHO a high flow is continuously delivered in the airways, a wash-out of the anatomical dead~     space should occur and CO2 clearance should be enhanced. Despite this strong physiological~     rational for the use of HFHO in patients suffering from COPD exacerbation, the effects of~     using HFHO instead of conventional oxygenotherapy in combination with non-invasive~     ventilation (NIV) in this context has never been explored.~      The main objective of the study is to explore the effects of using HFHO in combination with~     NIV in acute COPD exacerbation and to assess the underlying mechanisms of action.~   "
91345|NCT02371551|"~     The primary concern in complex renal cysts (CRC) with malignant potential is the accurate~     diagnosis and characterization. Patients with CRC have to undergo frequent imaging~     surveillance (every 6-12 Mo), in which the progression suggests a neoplastic process. The~     gold standard for establishing diagnosis and necessity for surgical intervention (i.e.~     partial nephrectomy) is conventional computer tomography (CT) imaging. Its main drawback is~     the radiation dose to the body and intravenous contrast media administration, which has a~     risk of nephrotoxicity.~      Magnetic resonance imaging (MRI) with special functional sequences (fMRI) and~     contrast-enhanced ultrasonography (CEUS) allow measuring tissue blood flow and perfusion~     characteristics without ionizing radiation or nephrotoxic contrast media. To compare the~     diagnostic accuracy, sensitivity and specificity of CEUS/functional MRI versus the gold~     standard CT, 60 patients with CRC will be evaluated using all these 3 modalities. The main~     hypothesis is that fMRI and CEUS have equal accuracy with CT regarding diagnosis and~     classification of CRC lesions.~   "
91346|NCT02371538|"~     Human Breast milk in young children with Norovirus Infection~   "
91347|NCT02371525|"~     To test the effectiveness of Prepmate, a novel multi-modal, technology-based intervention for~     pre-exposure prophylaxis (PrEP) adherence support among young men who have sex with men~     (MSM).~   "
91348|NCT02371512|"~     Study to assess mitral valve therapy for advanced insufficiency of functional or ischemic~     origin in patients with moderate-to-severe mitral regurgitation (MR) of primarily functional~     pathology and reduced left ventricular function considered to be at high surgical risk~   "
91349|NCT02371499|"~     The aim of the study is to collect data for the assessment of the Lactobacillus casei DG~     (Enterolactis plus®) effect on overall abdominal pain/discomfort, symptoms and gut microbiota~     composition in patients with Irritable Bowel Syndrome.~   "
91382|NCT02371070|"~     The investigators study aims to test the correlation between the Hemochron Signature~     point-of-care testing (POCT) device (ITC, USA) and low plasma levels of all three currently~     approved direct oral anticoagulants (DOAC; rivaroxaban, apixaban and dabigatran) and to~     determine the diagnostic accuracy of POCT to rule out or detect relevant levels of DOAC in~     real-life stroke patients.~   "
91766|NCT02366013|"~     This is a dose escalation study to test the safety and immunogenicity of an oral HIV-1~     vaccine.~   "
91350|NCT02371486|"~     Cesarean scar defects (CSDs), i.e. deficient uterine scars following a cesarean section,~     involve discontinuity at the site of a previous Cesarean section scar. These anatomical~     defects have been reported to be associated with postmenstrual spotting, chronic pelvic pain~     and infertility. Few case series have suggested improved fertility (most probably by~     improving implantation of embryos) The aim of this study is to prospectively record embryonal~     implantation rate during IVF in patients with CSDs, and to evaluate the effect of~     hysteroscopic repair of CSDs on fetal implantation during IVF.~   "
91351|NCT02371473|"~     Acetazolamide improves central sleep apnea related to opium consumption.~   "
91352|NCT02371460|"~     The aim of this randomized controlled trial is to determine whether docosahexaenoic acid (or~     DHA, an omega-3 lipid) supplementation in lactating mothers providing breast-milk to their~     infant born below 29 0/7 weeks of gestational age (GA) improves BPD-free survival at 36 weeks~     post-menstrual age (PMA). Half of participants will receive docosahexaenoic acid (DHA), an~     omega-3 lipid, while the other half will receive a placebo.~   "
91353|NCT02371447|"~     This phase I/II trial will assess the safety and efficacy of intravesical instillation of~     VPM1002BC in patients with recurrent non-muscle invasive bladder cancer after TURB~     (transurethral resection of the bladder) and standard BCG therapy. In phase I part of the~     trial, a 3+3 dose de-escalation design will be applied to determine the recommended phase II~     dose (RP2D). In phase II part of the trial, a maximum of 39 patients will be treated at RP2D~     to further assess the preliminary efficacy of VPM1002BC.The efficacy and tolerability of~     VPM1002BC will be compared to results previously reported for BCG in a similar population.~     The quality of life will be also investigated as a secondary endpoint. Additional immunology~     assessments are foreseen as exploratory analyses to investigate the immunogenicity of~     VPM1002BC.~      The Phase II of the trial has been opened on 27.07.2016.~   "
91354|NCT02371434|"~     The aim of this trial is to collect evidence of the safety of administering autologous~     CD4+CD25+FoxP3+ natural regulatory T cells (nTregs) to living-donor renal transplant~     recipients. In addition, the study will determine whether post-transplant nTregs infusion~     allows a tapering of conventional maintenance immunosuppression within 60 weeks after~     transplantation.~   "
91355|NCT02371421|"~     To pursue this objective, we will be measuring uric acid at baseline and post 14 days of~     twice daily allopurinol therapy in 30 Hmong participants with documented gout or~     hyperuricemia and known genotype for key renal transporters of uric acid.~   "
91356|NCT02371408|"~     The study will assess the efficacy of PPI-668 (USAN: ravidasvir hydrochloride) in combination~     with sofosbuvir, with or without ribavirin, in the following Egyptian HCV gt-4 patient~     populations:~        1. Treatment-naïve patients, with and without cirrhosis (Group 1)~        2. Previous non-responders to interferon-based therapies, without cirrhosis (Group 2)~        3. Previous non-responders to interferon-based therapies, with cirrhosis (Group 3)~   "
91357|NCT02371395|"~     Worldwide, approximately 2 billion people live in areas at risk for malaria with morbidity~     surpassing 250 million cases, with approximately 800,000 deaths, per year. Of the four~     species of malaria parasites that cause human infection, P. falciparum is responsible for the~     majority of severe malaria cases followed by P. vivax. Early and accurate diagnosis is~     essential for prompt and correct treatment, which can reduce the death rate and interrupt~     transmission. Currently, conventional methods for the diagnosis of malaria include~     microscopic examination of thin and thick blood smears and rapid diagnostic tests (RDTs).~     Light microscopy in practice typically detects parasitemia as low as 100 parasites/µl and it~     can differentiate species. The advantage of microscopy includes the ability to estimate~     parasitemia, the possibility to identify parasite stages, including gametocytes, and its low~     cost. However, this method is labor intensive, difficult to standardize, and requires~     well-trained microscopists. The majority of RDTs are based on detection of P. falciparum~     histidine-rich protein 2 (HRP-2) antigen and do not detect all malaria species. RDTs that~     detect lactose dehydrogenase (LDH) and aldolase generally broadly react with all four species~     of malaria parasites and therefore cannot differentiate among the species although efforts~     are underway to improve their performance for species detection. In settings where multiple~     malaria species co-circulate, molecular methods may be more reliable than microscopy and RDTs~     in accurately diagnosing the species of malaria parasites with low parasitemias. However,~     conventional molecular methods, such as nested polymerase chain reaction (nested PCR) or~     real-time PCR, are technically challenging and resource intensive and are generally~     restricted to reference laboratories due to the need for well-equipped laboratories.~     Recently, new molecular methods that can be used in field settings have been developed and~     this opens up new opportunities for exploring molecular tools for malaria diagnosis in~     endemic countries. With the objective of facilitating use of molecular tools for malaria~     control programs, the malaria laboratory at the Centers for Disease Control and Prevention~     (CDC) in Atlanta, USA developed a simple isothermal molecular method called Real-Time~     Fluorescence Loop-Mediated Isothermal Amplification (RealAmp) for the diagnosis of malaria.~     Currently, RealAmp primers exist for detecting the Plasmodium genus and the detection of P.~     falciparum and P. vivax species. The RealAmp method has great potential as a molecular tool~     for the diagnosis of malaria in the field (and other infections of major public health~     impact, such as HIV and tuberculosis). It can provide an alternative to conventional~     PCR-based diagnostic methods for field use in clinical and operational programs. The~     objective of this proposal is to validate the sensitivity of RealAmp for detection of malaria~     parasites in blood spots from patients with clinical diagnosis of malaria in two endemic~     states of Brazil with co-circulation of P. falciparum and P. vivax. In this evaluation,~     RealAmp and microscopic examination will be compared to a real-time PCR method as a reference~     test.~   "
91358|NCT02371382|"~     The purpose of this multicentre, prospective study is:~        -  Document the Clinical and Radiographic performance of the stem at 3 months, 1 year, 3~          years, 5 years, 7 and 10 years.~        -  Report Safety and Survivorship up to 10 years F/up.~   "
91359|NCT02371369|"~     This is a Phase 3 clinical study, which aims to evaluate the effectiveness of an~     investigational drug called pexidartinib for the treatment of certain tumors for which~     surgical removal could cause more harm than good.~      The main purpose of this study is to gather information about the investigational drug~     pexidartinib, which may help to treat tumors of pigmented villonodular synbovitis (PVNS) or~     giant cell tumor of the tendon sheath (GCT-TS).~      The study consists of two parts with a follow-up period. In Part 1, eligible study~     participants will be assigned to receive either pexidartinib or matching placebo for 24~     weeks. A number of assessments will be carried out during the course of the study, including~     physical examinations, blood tests, imaging studies, electrocardiograms, and questionnaires.~     MRI scans will be used to evaluate the response of the tumors to the treatment. Some~     subjects, assigned to placebo in Part 1 transitioned to pexidartinib for Part 2.~      Then a protocol amendment was written to allow only pexidartinib patients to continue into~     Part 2. Part 2 is a long-term treatment phase in which all participants receive open-label~     pexidartinib. There was also a follow-up period added to Part 2.~   "
91360|NCT02371356|"~     Depression during pregnancy is prevalent (15-20%) and has an adverse impact on fetal outcomes~     including preterm delivery (PTD) and low birthweight (LBW). Currently, significant confusion~     exists about if and how depression during pregnancy should be treated, given the unknown~     risk-benefit profiles of various treatments. We propose to conduct a two-stage prospective~     cohort study to determine if treating depression in pregnancy is effective in improving fetal~     outcomes, and which treatment is most effective: pharmacotherapy, psychotherapy or a~     combination. The risk-benefit of the treatments will be examined separately for two~     depression types: pregnant women with depression only and those with other psychiatric~     comorbidities to evaluate possible differences in treatment effectiveness between the two~     groups. Findings will provide answers to long standing stakeholder questions of how to treat~     depression in pregnancy and which treatment is most effective with the best risk-benefit~     profile in improving fetal outcomes. Selecting an effective treatment could reduce PTD or~     LBW, thus, reducing infant mortality and morbidity, and medical costs.~   "
91361|NCT02371343|"~     Gestational diabetes is the development of diabetes during pregnancy. Left untreated,~     gestational diabetes and preeclampsia can lead to serious -- or even fatal -- complications~     for both mother and child. Some evidence suggesting omega-3 fatty acids might help protect~     women from two serious pregnancy complications -- gestational diabetes and preeclampsia.~     Omega-3 fatty acids, in particular Docosahexaenoic acid (DHA), help a pregnant woman give her~     developing baby every advantage in life starting in-utero. Recent studies suggested that the~     biologic processes underlying the observed associations may involve epigenetic changes,~     specifically DNA methylation. In this study the investigators aimed to examine the effect of~     fish oil supplementation in women with gestational diabetes mellitus on newborn outcomes and~     insulin like growth factor 1 DNA methylation.~   "
91559|NCT02368743|"~     This national, observational and multicentre study aims at establishing a picture of real~     clinical practices management among patients treated with Pentasa®, according to the current~     therapeutic strategy in proctitis or distal proctosigmoiditis. This study should be able to~     provide data on patients' health related quality of life, compliance and efficacy in real~     clinical practice~   "
91362|NCT02371330|"~     This is a prospective longitudinal study that evaluates Platelet Function Analyzer-100~     (PFA-100) CT-ADPs (closure time-ADP) and incidence of bleeding using the Neonatal Bleeding~     Assessment Tool - Neo-BAT in preterm neonates <32 weeks gestational age or with a birth~     weight <1500 grams and with different degrees of thrombocytopenia.~      The investigators hypothesized that PFA-100 CT-ADP, a global in vitro test of primary~     hemostasis, will be a better predictor of clinical bleeding in neonates than platelet count~     alone. A bleeding risk assessment marker could help physicians more accurately determine the~     risk/benefit ratio of platelet transfusions, guiding platelet transfusion decisions in~     neonates with thrombocytopenia.~   "
91363|NCT02371317|"~     The purpose of this research study is to examine the efficacy of two stress management~     interventions in reducing blood pressure (BP) in patients who have prehypertension (BP~     between 120/80 and 139/89). It is expected that participants will be better able to control~     their BP through reducing stress and increasing healthy lifestyle behaviors.~   "
91364|NCT02371304|"~     Current therapy for early colorectal cancer is radical Total Mesorectal Excision (TME).~     Colorectal surgical resections are accompanied with high morbidity of up to 33% and 90 days~     mortality of up to 9% in the fragile elderly patients as is seen in the results of the Dutch~     Surgical Colorectal Audit (DSCA) of 2013. Additionally, rectal cancer surgery is associated~     with substantial loss of health related quality of life due to defecation disorders,~     incontinence, sexual dysfunction and stoma related morbidity. These disadvantages are~     acceptable when radical surgery is the only option for cure. Advances in technology enabled~     the development of local excision of early rectal cancer with precise endoluminal~     microsurgery or local endoscopic excision resulting in a significant decrease in short- and~     long term morbidity. However current evidence is of inadequate quality to conclude on the~     oncologic safety of local treatment for early rectal cancer. Imaging can predict outcome and~     tailors treatment in more advanced cancer but fails in early cancer. Pathological assessment~     of the excised tumor tissue provides the optimal information on tumor stage, tumor~     characteristics and tumor differentiation, thereby it enables to predict the risk of~     recurrence after local treatment alone. For early rectal cancers, with a low risk on~     recurrence based on favourable tumor characteristics local excision is seen as safe and these~     patients do not require an additional treatment. However, for patients with early rectal~     cancer with a higher risk on recurrence based on tumor characteristics there is no consensus~     on the additional treatment after local excision. According to the National guideline these~     patients receive a TME procedure. However, for this subgroup of patients local treatment~     followed by chemoradiotherapy might also be oncological safe. Current evidence is of~     inadequate quality to be conclusive. For this subgroup of patients with early rectal cancer~     with high risk tumorcharacteristics the TESAR trial is designed, in which patiens will be~     randomised after local endoluminal excision between an additional TME-procedure (standard)~     and adjuvant chemoradiotherapy. Primary endpoint of the study will be local recurrence at 3~     three year follow-up.~   "
91365|NCT02371291|"~     Our collection of memories for personal experiences plays an important role in shaping our~     sense of who we are as people. These memories, termed autobiographical memories, can also be~     helpful in social situations, for sharing the details of our experiences with other people,~     reminiscing about pleasant times and solving problems by remembering what has and hasn't~     worked in the past. Different types of autobiographical memory are helpful to us depending on~     the particular situation the investigators are in at the time. Recent research has shown that~     experiencing depressed mood can affect how we relate to our autobiographical memories, so~     that instead of providing a rich source of personal information in a helpful and flexible~     way, the types of memories that come to mind are more narrowly focused on difficult or~     negative experiences. This can cause low mood to persist over time.~      The purpose of this study is to test a newly-developed therapeutic training package for~     depressed mood (MemFlex), designed to encourage helpful and flexible ways of relating to~     autobiographical memories. The MemFlex programme consists of a one-to-one orientation session~     with the researcher to introduce the training package, followed by a workbook that is~     completed at home.~   "
91366|NCT02371278|"~     The loss of muscle mass with aging is associated with a dysregulation of muscle protein~     synthesis (MPS) that is generally characterized by a suppressed MPS response to protein~     ingestion. This 'anabolic resistance' to protein feeding can be overcome with the ingestion~     of larger protein servings (~0.4g/kg/meal, equivalent to ~ 30 - 40g/meal); however, older~     adults would likely find it challenging to consume such quantities of protein on a per meal~     basis.~      The amino acid leucine has a unique role as a key 'activator' of MPS. Some research shows~     that increasing the leucine content of a suboptimal dose of a protein supplement can enhance~     the MPS response in older adults. However it is currently unknown whether the co-ingestion of~     leucine with normal, mixed meals can increase MPS. Furthermore, it has been suggested that~     leucine supplementation may only benefit older adults consuming suboptimal daily protein~     intakes. Therefore, the purpose of the current study is to examine the impact of leucine~     co-ingestion with mixed macronutrient meals on the myofibrillar protein synthetic response in~     older men consuming daily protein intakes at or below the current recommendations. A further~     objective is to determine whether the myofibrillar protein synthetic response to a session of~     resistance exercise is enhanced by leucine supplementation with meals. The investigators~     hypothesize that, in both the exercised and non-exercised condition, leucine co-ingestion at~     meals will enhance integrative myofibrillar protein synthesis in older adults consuming lower~     daily protein intakes, but will not augment MPS in those consuming higher daily protein. The~     investigators further hypothesize that the influence of leucine supplementation on MPS will~     be greater in the exercise condition than the non-exercise condition.~   "
91367|NCT02371265|"~     The overall objective of the study is to develop and test a pilot intervention in central~     Mozambique to implement the new WHO Option B+ guidelines that seek to increase the~     proportion of HIV-positive pregnant women in six antenatal care clinics who start~     antiretroviral therapy (ART) prior to delivery, and are retained in care after 90- days.~   "
91368|NCT02371252|"~     Osteoporosis is a common disease defined as a decrease in bone mass and strength which~     increases risk of fragility fractures. This disorder may affecting health in many adults~     which causing disability, morbidity, and mortality. Current first-line medical therapy is~     bisphosphonates which alendronate is one of the most widely used. However, expenditure on~     medicines is one of the major problem of inadequate access to treatment.~      The investigators hypothesized that generic alendronate will have the same clinical efficacy~     as the brand formulation. Therefore, the result of this study is extremely crucial. If~     adequate efficacy of generic alendronate could be established and if it affords the same~     safety profile as those of brand alendronate, the use of generic alendronate could then be~     recommended.~   "
91560|NCT02368730|"~     In this non-interventional multicentre, prospective, observational cohort study, the efficacy~     of desmopressin is evaluated in patients with platelet dysfunction due to acetylsalicylic~     acid or cox-1-inhibitors within the context of surgical procedures.~   "
91767|NCT02366000|"~     The aim of this study is to identify parent-children communication in relation to health risk~     behaviors (smoking, drinking and illegal drug taking) in adolescents, and to enhance better~     parental skills in preventing these behaviors in children.~   "
91369|NCT02371239|"~     Introduction: Changes in lifestyle are responsible for an important part of the type 2~     diabetes epidemic of the last decennia. Current guidelines for physical activity focus mainly~     on high energy expenditure advising 30 minutes per day moderate to vigorous physical activity~     (most often physical exercise). Recent studies suggest that sitting has negative metabolic~     effects independent of the time spent exercising (Duvivier et al. PLOS ONE 2013).~      Low intensity physical activity (LIPA) -such as walking and standing- has been suggested to~     be an alternative to decrease the hyperglycaemic effect of sitting. Compared to exercise,~     LIPA might be a more feasible strategy. But, it remains to be determined whether reducing~     sitting time by replacing it by LIPA, results in lower 24 hour blood glucose levels and less~     blood glucose fluctuations (glycaemic variability) in type 2 diabetes patients and whether~     these effects are independent of the increase in energy expenditure~      Methods: The study population will involve 19 people with type 2 diabetes (BMI: 25-35 kg/m2)~     who perform no, or only little, exercise and who are treated with diet only or with oral~     blood glucose lowering medication. They will perform three regimes of each four days: 1) a~     sitting regime, 2) an exercise regime and a 3) sit less regime. Daily energy expenditure of~     the exercise regime will be identical to that of the sit less regime. Sitting, walking and~     standing will be objectively measured by a 24 hour physical activity monitor. The energy~     spent during exercise will be standardised and quantified by using a bicycle ergometer;~     energy intake will be standardised as well. During each regime blood glucose will be measured~     with a 24 hour continuous glucose sensor.~   "
91370|NCT02371226|"~     AGT-181 is a fusion protein containing alpha-L-Iduronidase that is intended to deliver the~     enzyme peripherally and to the brain, when administered intravenously. This study is a safety~     and dose ranging study to obtain safety and exposure data, as well as information on the~     biological activity of the investigational drug.~   "
91371|NCT02371213|"~     The purpose of the study is to determine whether social networking on mobile phone in~     antenatal care health education is effective in the improvement of maternal and neonatal~     outcomes compared with usual antenatal care.~   "
91372|NCT02371200|"~     Prospective study of an electromyography (EMG) based seizure detection and warning system for~     detecting generalized tonic-clonic (GTC) seizures.~   "
91373|NCT02371187|"~     Exercise is frequently prescribed as a favorable lifestyle intervention to prevent/reverse~     type 2 diabetes. It is also prescribed in addition to concurrent pharmacological treatment,~     such as metformin. Recent data (animal and human) suggest that metformin may attenuate the~     favorable benefits of exercise training. In light of the physiological mechanism of~     Dapagliflozin (sodium-glucose co-transporter 2 (SGLT2) inhibition), one might speculate that~     rather than inhibit, it will augment the favorable adaptations to exercise training.~   "
91374|NCT02371174|"~     The primary objective of the study is to clarify factors affecting the incidence of~     peripheral neuropathy in patients treated with HALAVEN. A total of 590 patients will be~     enrolled in this study with 295 patients in the treatment group of primary or secondary~     chemotherapy and 295 patients in the treatment group of tertiary or later chemotherapy.~   "
91375|NCT02371161|"~     A phase II prospective, non-randomized study. The study aim is to evaluate the feasibility~     and activity of high-dose therapy with stem cell in elderly patients with aggressive lymphoma~     relapsed FIT or resistant to first line therapy.~   "
91376|NCT02371148|"~     This is a prospective, multicenter phase II trial designed to determine efficacy and safety~     of Bortezomib plus Rituximab plus Bendamustine in patients with relapsed/refractory~     Waldenstrom's Macroglobulinemia.~   "
91377|NCT02371135|"~     The purpose of this study is to understand the role bacteria that normally live in the colon~     may play in colorectal cancer risk, in addition to the hereditary risk to colorectal cancer.~     The investigators will collect stool specimens as well as additional colon biopsy specimens~     during the patient's scheduled colonoscopy procedure. The investigators will also collect a~     questionnaire about diet and lifestyle. The samples will be used to study the impact of diet~     on naturally-occurring oral and gut bacteria and their influences on human health including~     risk of cancer.~   "
91378|NCT02371122|"~     The purpose of this study is to evaluate the effect of different spinal cord stimulation~     settings in the treatment of leg pain. Subjects will receive a randomized order of four~     different programmed stimulation settings for 3 weeks each followed by a fifth and final~     setting.~   "
91379|NCT02371109|"~     Routine screening for gonorrhoea and chlamydia involves urine samples in males and selftaken~     vulvovaginal swabs (VVSs) in females. As well as infecting the urethra (pee tube) and cervix~     (neck of womb), gonorrhoea and chlamydia may also infect the rectum (bottom) and throat (both~     called extragenital sites), often with no symptoms. In some people infection will be found at~     more than one site, but in others it will only be in one, and if all anatomical sites are not~     tested some infections will be missed. In certain women one third of infections may be~     missed, in men who have sex with men (MSM) up to 90% may be missed, if extragenital swabs are~     not taken. Currently, routine community testing does not include extragenital sites. Until~     recently these samples could not easily be taken outside clinical settings (hospitals,~     clinics or surgeries), but new DNA tests for gonorrhoea, called NAATs, now make this~     possible.~      However, they are expensive, and taking samples from extragenital sites would treble the~     costs. We propose that swabs from the three sites per person are pooled and analysed together~     rather than tested separately. This method would identify whether the person had the~     infection but not the anatomical site; this would not alter the management of the individual.~     Swabs from the rectum and throat have historically been taken by clinicians (doctors or~     nurses). The main attraction of community screening is that it is client led using selftaken~     samples. Recent studies suggest that selftaken swabs from the rectum and throat are~     acceptable to clients and may be as good as swabs taken by clinicians, but the~     costeffectiveness of this approach has not been investigated. Our aim is to establish whether~     in MSM and females selftaken samples that are pooled and processed by NAATs are as effective~     as the individual tests taken by clinicians.~   "
91380|NCT02371096|"~     Pharmacokinetic properties, efficacy, safety and tolerability of RGB-03 and MabThera will be~     compared in patients suffering from Rheumatoid Arthritis.~   "
91381|NCT02371083|"~     This is a prospective trial to investigate optimal timing of care for vaginal pessaries. A~     vaginal pessary is a silicone device that is placed in the vagina to support the pelvic~     organs of a woman who has pelvic organ prolapse. Some women are willing and able to remove~     their own pessary on a regular basis. In women who are either unwilling or unable to remove~     their own pessary, complete pessary care is provided in the urogynecology office. Complete~     pessary care involves regular removal and cleaning of the pessary with a vaginal examination.~     In our practice, the investigators typically remove vaginal pessaries and examine the vagina~     every 3 months in patients for whom the investigators provide complete pessary care. Interval~     of pessary removal varies widely between practitioners. In the literature, removal intervals~     vary from weekly to yearly. In this study, the investigators will randomize participants to~     pessary care with removal every 12 weeks or every 24 weeks.~   "
91383|NCT02371057|"~     Estimates of the prevalence of acromegaly, a condition resulting from excess growth hormone~     secretion, are as high as 1:1000. If detected late acromegaly increases the risk of joint~     destruction, heart disease, sleep apnoea, high blood pressure, diabetes, and polyps in the~     colon. To have a greater effect on long-term outcomes this disease needs to be detected~     early. By screening a 'high risk' population (sleep apnoea clinic) the investigators may be~     able to detect these patients earlier and prevent late complications of the disease. At LTHT~     the referral pathway for new referrals to the sleep apnoea clinic involves initial attendance~     to pick up a pulse oximeter to wear overnight to measure oxygen levels. These readings show~     approximately 1:4 patients displays evidence of significant obstructive sleep apnoea to~     warrant referral to the treatment group for continuous positive airway pressure (CPAP),~     weight management, and occasionally mandibular adjustment.~      Patients attending the sleep apnoea clinic either as new referral or for review will be asked~     to participate in the proposed study. The study is cross-sectional in design incorporating~     two sub-populations within the sleep apnoea clinic. The first cohort comprises patients under~     follow-up known to have sleep apnoea, and the second cohort those patients prospectively~     attending the sleep apnoea clinic for assessment. If after an explanation of the study they~     agree to participate blood will be taken for assessment of IGF-I and they will be asked to~     complete a simple questionnaire.~      The aim will to be to screen 1000 consecutive patients. The questionnaire will incorporate~     five simple questions to be completed with a 'yes' or 'no' answer. Where IGF-I levels are~     elevated patients will be investigated further for the possibility of acromegaly. The~     presence of biochemically proven acromegaly will be used to determine if the simple question~     has sufficient sensitivity to use as a screening tool.~   "
91384|NCT02371044|"~     The investigators study aims to test the correlation between the CoaguChek point-of-care~     testing (POCT) device (Roche, Switzerland) and low plasma levels of all three currently~     approved direct oral anticoagulants (DOAC; rivaroxaban, apixaban and dabigatran) and to~     determine the diagnostic accuracy of POCT to rule out or detect relevant levels of DOAC in~     real-life stroke patients.~   "
91385|NCT02371031|"~     This is a pilot study designed to evaluate the potential of using FDOPA-PET/MRI for improving~     surgical planning and providing non-invasive prognostic information in patients with gliomas~     that have substantial non-enhancing regions. The results will be used to develop larger~     adequately powered studies.~   "
91386|NCT02371018|"~     The purpose of this study is to examine the effect of nutritional supplementation during~     hemodialysis treatment on beat-to-beat hemodynamics and treatment efficiency in a crossover~     design.~   "
91387|NCT02371005|"~     Systemic sclerosis (SSc) is a rare multisystem connective-tissue disorder characterized by~     three major pathological hallmarks: widespread fibrosis, vasculopathy and immunological~     abnormalities. As all connective tissues can be affected, this condition has multiple effects~     on the orofacial region. Indeed, the latter is involved in approximately 80% of SSc patients.~     Oral manifestations have a major impact on quality of life and require specific treatments~     that should be performed as early as possible.~      Widening of the periodontal ligament space, that seems to be linked to an increased collagen~     synthesis, is one of the most common dental radiographic finding. However, this radiologic~     sign has been mostly studied on two-dimensional radiographs. The investigators have recently~     described in a patient suffering from SSc the existence of calcifications within the~     periodontal ligament space using Cone Beam Computed Tomography (CBCT) approach (Jung et al.,~     Oral Surg Oral Med Oral Pathol Oral Radiol 2013). Such calcifications, that have never been~     observed before, could be part of the phenotypic spectrum of the disease, in particular when~     dystrophic calcinosis is associated. They could furthermore constitute a specific feature of~     SSc. However, this radiographic sign requires to be investigated in a largest number of~     patients.~      Several cytokines have been implicated in SSc pathogenesis. A recent study has revealed that~     elevated CXCL4 serum levels correlate with disease complications, suggesting that this~     molecule could be used as a prognostic biomarker. Increased IL-6 serum levels also correlate~     with SSc severity. Gingival crevicular fluid can be easily collected from the gingival~     crevice surrounding the teeth and constitute an indicator of local but also systemic~     inflammation. Analysis of gingival crevicular fluid cytokine profile could contribute to the~     identification of specific SSc biomarkers and allow a better comprehension of oral~     manifestations pathogenesis.~      The aim of this case-control study is to characterize precisely the oral manifestations~     associated with SSc within the National Referral Center for Rare Autoimmune Diseases~     (Strasbourg, France) patient cohort in order to identify specific radiological, clinical~     and/or biological signs. Some of them could be correlated to the severity or to the prognosis~     of the disease. To the investigators knowledge it is the first study using tridimensional~     CBCT approach.~   "
91388|NCT02370992|"~     Low dose rate brachytherapy using iodine 125 is well established as a treatment for low and~     intermediate risk prostate cancer. Currently there is uncertainty as to the safety of this~     technique in patients who have had a previous transurethral resection of the prostate gland~     (TURP) for obstruction of the urine flow through the prostatic urethra. Early experience when~     the technique was being developed in the 1980s suggested that there was a higher incidence of~     urinary incontinence after brachytherapy if there had been a previous TURP. It is however~     clear that with increasing experience many centres offer this treatment to patients who have~     had previous TURP, using various parameters to select patients including time from the TURP~     and persence or absence of a significant cavity within the gland on MRI scanning. There has~     been no systematic study of I125 brachytherapy after TURP in the current era which might~     address and inform the practice for future patient. Hence this study is designed to formally~     assess the safety of I125 brachytherapy after previous TURP.~   "
91389|NCT02370979|"~     This is a multi-center prospective study. The primary objective of DRONE study is to~     investigate the change of the size of HIV-1 DNA reservoir in blood from baseline to week 48~     (W48) in participants treated by DTG-based regimen. Secondary objectives include: DTG~     pharmacokinetic and analysis of biomarkers of immune activation from baseline to W48.~   "
91390|NCT02370966|"~     The purpose of this study is to determine whether intake of berry powder effective in the~     treatment of systemic and oral inflammation.~   "
91391|NCT02370953|"~     OVERVIEW Cataract is a clouding of the crystalline lens which causes vision loss and~     blindness if untreated. Cataract surgery is the most frequently performed surgical~     intervention in medicine with an incidence of 880 surgeries per 100.000 population in 2010~     amounting to a total number of over 160.000 surgeries per year in the Netherlands.~      Approximately 22% of patients with cataract have a substantial pre-existing corneal~     astigmatism. Toric IOLs provide the opportunity to correct pre-existing astigmatism, offering~     the patients optimum distance vision without the use of spectacles or contact lenses. Toric~     IOLs are increasingly used in cataract and refractive surgery.~      Since the introduction of toric intraocular lenses (IOLs) in the treatment of cataract in~     patients with pre-existing corneal astigmatism, numerous studies have shown the importance of~     accurate positioning of the toric IOL to the intended alignment axis. An error of 5º in toric~     IOL alignment will decrease the anticipated effect by 17% and thus misalignment will decrease~     the effectiveness of the astigmatism treatment. There are several methods used to align the~     toric IOL at the intended axis. Most of these use a 3-step ink-marking procedure and are~     performed manually. Clinical study showed an average error of 5º in toric IOL alignment when~     using this method.~      Two new tools that have recently been introduced to the market are the VERION Measurement~     Module and VERION Digital Marker. Together, these tools provide integrated digital guidance~     for alignment of toric IOLs and they have the potential to eliminate the error in horizontal~     axis marking and the alignment axis marking error. This will lead to an improved visual~     outcome. So far, there are no published studies using the VERION tools for toric IOL~     alignment in cataract surgery. Therefore, the investigators will perform this randomized~     control trial.~      MAIN HYPOTHESIS~      The investigators hypothesise that cataract surgery with the implantation of a toric IOL,~     when using the VERION-tools, compared to manual ink-marking, in patients with corneal~     astigmatism will lead to:~      - An increase in accuracy in toric IOL alignment~      OBJECTIVES~      Primary Objective:~      The primary objective of the study is to compare the accuracy in toric IOL alignment when~     using the VERION-tools for alignment of the toric IOL or the conventional manual ink-marking~     procedure.~      Other hypotheses and objectives are available in the detailed description.~   "
91392|NCT02370940|"~     The purpose of this study is to investigate whether regular consumption of phytate dampens~     its negative effect on nonheme iron absorption.~   "
91393|NCT02370927|"~     The objectives are to test the acute effects of different cereals containing pulse~     ingredients on: 1) aerobic endurance and substrate oxidation during exercise 2) response of~     blood glucose, insulin and appetite to an aerobic exercise session, and 3) food intake two~     hours following the exercise session. The investigators hypothesize that consumption of~     cereals containing pulse ingredients 60 minutes before exercise will increase aerobic~     endurance (lower oxygen consumption), decrease carbohydrate oxidation (greater respiratory~     quotient), and a reduction in lactate production during compared to the same exercise session~     following the ingestion of a non-pulse food. The investigators also hypothesize that~     consumption of cereals containing pulse ingredients will lead to lower blood glucose,~     insulin, appetite and food intake, suggesting lower calorie compensation, following a~     60-minute aerobic exercise session compared to the same exercise session following the~     ingestion of a non-pulse food.~   "
91394|NCT02370914|"~     The purpose of this study is to establish and evaluate a distinctive signal for concussion.~   "
91395|NCT02370901|"~     Babies 4-7 months of age with positional plagiocephaly will be treated with repositional~     techniques verse helmet therapy. The helmet therapy children will be fitted a helmet at~     Westcoast Brace and Limb and monitored during treatment to ensure proper fitting of helmet.~     The repositioning children's parents will given instructions on how to perform neck~     stretching exercises and repositioning techniques and monitored during treatment. The~     anthropometric measurements will be done by licensed orthotist at monthly intervals for a~     total of six months of treatment. Before treatment, 6 months, 12 months, and 24 months from~     treatment all of the children will be scanned by Star Scanner (Orthomerica) to provide~     objective measurement of the cranial vault asymmetry and index.~   "
91396|NCT02370888|"~     The purpose of this study is to determine the maximum tolerated dose, dose limiting side~     effects, and the safety of increasing doses of lenalidomide in patients with AML and MDS who~     have a small amount of detectable disease after allogeneic stem cell transplant.~   "
91397|NCT02370875|"~     Benign essential blepharospasm (BEB) is a functionally disabling focal dystonia. Botulinum~     neurotoxin (BoNT) therapy is suboptimal in many BEB patients. Repetitious transcranial~     magnetic stimulation (rTMS) therapy is a promising noninvasive therapy and has shown positive~     benefits in BEB. rTMS therapy can be easily combined with BoNT injections to enhance the~     effects of BoNT in BEB.~   "
91398|NCT02370862|"~     Bowel care (BC) is a time-consuming and cumbersome activity of daily living for most~     individuals with SCI. Previous studies have reported that the average time to complete a BC~     routine is 45 minutes; 10-20% of SCI individuals report BC routines lasting for more than 1~     hour. In past studies, the investigators have shown that a medication called neostigmine~     (NEO) combined with a medication called glycopyrrolate (GLY) can increase bowel activity and~     thus, promote bowel movement. The investigators have successfully used this medication with~     traditional and novel methods of colonoscopic preparations, and have shown that it improves~     the quality of these preparations. In this Phase I, proof of concept pilot study, the~     investigators propose to study the effectiveness of this medicine when it is delivered~     through the skin. In order to make delivery more efficient, the investigators will be using a~     technique called iontophoresis, which uses a mild electric current to drive the drug through~     the surface of the skin. The instrument includes an electrode containing the active agent~     (delivers charge) and an oppositely charged electrode (receives charge) which will be placed~     on the surface of the skin. The study design will consist of a screening visit to determine~     each individual's response to a previously established IV dose of NEO and GLY, followed by a~     dose titration study (two visits) of iontophoresed NEO and GLY. Study visits will be~     separated by no less than 2 days and no more than 14 days.~      If this delivery method is shown to be effective, it may represent a way to vastly improve~     the clinical utility of this medication by allowing for needle-free self administration, and~     expanding the clinical indication to routine, at home bowel care.~   "
91399|NCT02370849|"~     In this open-label, single-center, small sample size, randomised, parallel-group, controlled~     study, the investigators aim to assess efficacy and safety of addition of nimotuzumab to CS~     chemotherapy in patients with previously untreated advanced gastric adenocarcinoma. Sixty-two~     patients are required and randomly assigned (1:1) to each group.~      The control regimen (CS chemotherapy) is recommended as the standard first-line regimen for~     advanced adenocarcinoma of the stomach or gastroesophageal junction in japan.~   "
91400|NCT02370836|"~     This study evaluates that effects of psycho-oncological education on distress and quality of~     life in solid tumor cancer patients who have completed chemotherapy with curative intent.~     Half of the participants will received a psycho-oncological educational intervention while~     the other half will receive usual care.~   "
91401|NCT02370823|"~     The primary objective of this study is to determine the levels of proteins and/or cellular~     components of the synovial fluid that are indicative of microenvironment phenotypes of the~     osteoarthritic knee compared to unilateral unaffected joints pre-injection to 6 weeks~     post-Regenexx® SD treatment.~   "
91402|NCT02370810|"~     The purpose of this study is to determine the feasibility and effectiveness of a CBT-based~     internet intervention for adults with tinnitus in the United Kingdom~   "
91403|NCT02370797|"~     The purpose of this study is to determine if lumpectomy followed by Intraoperative Electron~     Radiation Therapy (IOeRT) as a single, full dose partial breast irradiation will have as good~     or better results in preventing recurrence of local breast cancer, cosmetic appearance and~     early and late side effects.~   "
91404|NCT02370784|"~     The purpose of this study is to learn about the effect atorvastatin on blood vessel function~     and Raynaud symptoms in patients with early diffuse systemic sclerosis.~      Systemic sclerosis is a disease characterized by blood vessel injury, immune system~     activation and fibrosis. Blood vessel injury is thought to be important early in the disease.~     Blood vessel complications of systemic sclerosis include Raynaud phenomena, finger and toe~     ulcers, and pulmonary hypertension. While atorvastatin reduces cholesterol, it is recognized~     to have many effects beyond cholesterol reduction. These include improvement of blood vessel~     function and reduction of fibrosis. We hypothesize that treatment with atorvastatin over 16~     weeks will improve blood vessel function and Raynaud symptom in patients with early diffuse~     systemic sclerosis. We hope that by targeting therapy early in the disease we may delay blood~     vessel changes and improve Raynaud symptoms.~   "
91405|NCT02370771|"~     Hand osteoarthritis is a common phenotype of osteoarthritis which affects about 70 % of the~     elderly population. Usually considered as a minor illness, it nevertheless leads to an~     important functional impairment. The mechanism of this disease is still poorly known.~     Furthermore there are 2 different subtypes : erosive and non erosive hand osteoarthritis from~     which mechanisms may differ.~      Methods:~      This is a cross-sectional study recruiting patients with hand osteoarthritis addressed in~     consultation of rheumatology and plastic surgery in Rouen University Hospital.~      Two groups of patients will be studied: 20 patients with non erosive subtype of hand~     osteoarthritis and 20 patients with erosive subtype of hand osteoarthritis.~      A clinical evaluation of hand osteoarthritis will be performed. Blood sample for proteomic~     analysis will be taken. Hand MRI and Bone Mineral Analyser will be performed.~   "
91406|NCT02370758|"~     This study will evaluate whether a test for Cytomegalovirus (CMV) specific cell-mediated~     immunity can be used to determine whether patients who complete a course of therapy for CMV~     viremia need secondary antiviral prophylaxis. Subjects that have negative CMV CMI will~     receive antiviral prophylaxis for 2 months and those with positive CMV CMI will have their~     prophylaxis stopped.~   "
91407|NCT02370745|"~     This study has two protocols the aims of which are:~        1. To identify age-related effects of AA on incretin secretion and whether and to what~          extent AA exhibit a true incretin effect (gut- mediated increases in plasma insulin) in~          younger individuals. (Protocol 1)~        2. To define the extra-pancreatic ''novel'', insulin independent effects of glucagon like~          peptide-1 (GLP-1) on postprandial muscle protein and glucose metabolism and~          microvascular blood flow. (Protocol 2)~   "
91408|NCT02370732|"~     The proposed project will help to understand the changes in reinforcement and impairment~     experienced by Roux en Y bariatric surgery (RYGB) patients who consume alcohol. In this study~     the investigators propose to investigate RYGB patients with a prospective, longitudinal~     design. Investigators will examine driving impairment before and after surgery as well as~     study cognitive changes and reinforcement changes that may occur in RYGB patients while~     consuming alcohol. Finally, investigators aim to better characterize the changes that occur~     in the pharmacokinetics of alcohol following bariatric surgery and examine key variables~     which may play a role in the development in alcohol use disorders.~   "
91409|NCT02370719|"~     The purpose of this study is to evaluate a patient-centered diabetes self-management mobile~     application (app), which was developed with feedback from both patients and healthcare~     providers. During the 12 month randomized control trial, participants in the intervention~     group will be provided with a mobile phone and commercial home medical devices, such as a~     weight scale, glucometer and activity monitor. The measurements taken from the medical~     devices will wirelessly transfer to the mobile phone, where the app will assess the data and~     provide patients with actionable self-management knowledge. The proposed intervention may be~     helpful in increasing adherence to recommended self-care practices, improving self-efficacy,~     and enhancing the overall patient experience.~   "
91410|NCT02370706|"~     This is a phase Ib study with the primary purpose is to estimate the MTD and/or RDE for the~     triple combination of PIM447, formerly LGH447, plus ruxolitinib and LEE011 as well as for the~     doublets, PIM447 plus ruxolitinib, and LEE011 plus ruxolitinib, in patients with~     myelofibrosis (MF). Each regimen will be assessed for safety, tolerability, pharmacokinetics~     (PK) and pharmacodynamic effects, and preliminary anti-myelofibrosis activity, including~     changes in spleen volume, JAK2V617F allele burden, and hematologic response.~   "
91411|NCT02370693|"~     The purpose of this study is to look at whether bortezomib, mycophenolate or the combination~     of both is better to treat scarring of the lung caused by Systemic Sclerosis.~   "
91412|NCT02370680|"~     This study is being conducted to evaluate the safety and the length of effect on platelet~     build-up in the arteries of Durlaza™ as compared to immediate-release Bayer® aspirin 81 mg or~     subject's current aspirin 81 mg of choice in patients who have Type 2 diabetes mellitus and~     cardiovascular disease or multiple risk factors of developing cardiovascular disease.~   "
91413|NCT02370667|"~     Prescribing exercise for people with painful knee osteoarthritis (OA) is essential for pain~     management, improved function, and chronic disease prevention. Exercise that decreases joint~     exposure to damaging loading while eliciting adequate muscular activation for strength~     improvements is ideal. The purpose of this 3-arm RCT is to compare mobility, strength, pain,~     and MRI outcomes between the low-loading biomechanical exercise program (BE), a traditional~     exercise program for knee OA (TE), and a control group completing meditation classes (M).~   "
91414|NCT02370654|"~     This study will evaluate the effects of Chen-style Tai Chi compared to conventional exercise~     in pulmonary rehabilitation for COPD patients. Half of participants will receive the~     Chen-style Tai Chi intervention, while the other half will receive the conventional exercise~     intervention. Both groups will receive the same eduction and support during pulmonary~     rehabilitation.~   "
91415|NCT02370641|"~     A total of 20 individuals, 10 urolithin excretors and 10 nonexcretors will be enrolled. The~     excretor status will be determined by analysis for urolithin A glucuronide in 24 hour urine~     after one dose of POMx. A blood sample and stool sample will be obtained before administering~     the extract. Subjects will be asked to consume one capsule of 1000 mg POMx daily for 4 weeks.~     At day 28, a blood sample, 24 hour urine sample will be obtained, and the stool collected by~     the participant in the prior 24 hours will be returned to the Center. Blood and urine~     urolithin, ellagic acid levels and stool bacteria enumeration and identification (including~     pyrosequencing) will be measured with the samples collected. A stool DNA sample will be~     preserved and frozen for potential future measurement of gene-nutrient interaction in~     pomegranate metabolism.~      Throughout the study participants will be instructed not to consume pomegranate products,~     walnuts, or polyphenol-rich fruits ((strawberry, raspberry etc) or juices drawn from a list~     used in prior studies. The study will be carried out in accordance with the guidelines of the~     Human Subjects Protection Committee of the University of California, Los Angeles. All~     subjects will give written informed consent before the study begins. Participants will be~     recruited by advertisement in the local newspaper in the Los Angeles Area close to UCLA.~   "
91561|NCT02368717|"~     The purpose of this study is to investigate the efficacy and safety of 4-week double-blind~     treatment with PENTASA enema compared with placebo enema in Chinese patients with mild to~     moderate active left-sided ulcerative colitis, followed by a maximal 28-week open-label~     extension phase with PENTASA enema and/or PENTASA tablets.~   "
91416|NCT02370628|"~     The VITTA trial is a randomized, controlled, single-blinded, cross-over trial comparing~     percutaneous vertebroplasty with facet block in patients with acute (<1month) and painful~     vertebral compression fractures.~      The treatment offered for vertebral compression fractures (VCFs) in the interventional arm of~     the trial is vertebroplasty, which will be performed in accordance with the standardized~     protocol of the Canadian Association of Radiologists. Patients in the control arm will~     receive facet block, where a long-acting local anesthetic agent and corticosteroids are~     injected in the spinal articular facets at the affected level.~   "
91417|NCT02370615|"~     The purpose of this study is to evaluate the effect of repeated-dose administration of~     itraconazole on the pharmacokinetics of TAK-272, as well as the effect of repeated-dose~     administration of TAK-272 on the pharmacokinetics of digoxin or midazolam in healthy Japanese~     adult males.~   "
91418|NCT02370602|"~     The purpose of this study is to estimate phosphodiesterase 10A (PDE10A) occupancy in brain~     following a single dose of TAK-063.~   "
91419|NCT02370589|"~     This is a randomized, observer-blind, placebo-controlled trial in male and female subjects~     ≥18 to <50 years of age. Subjects will be healthy adults based on history, physical~     examination, and baseline clinical laboratory testing.~      Approximately 230 eligible subjects will be enrolled into 1 of 13 treatment groups.~      Treatments will comprise two IM doses at a 21-day interval (Day 0 and Day 21), in alternate~     deltoids with the test article assigned (i.e., saline placebo, dose of EBOV GP vaccine with~     or without Matrix-M adjuvant), in a 0.5mL injection volume.~   "
91420|NCT02370576|"~     Determination of incidence and prevalence of PTSD and other types of psychopathology (such as~     anxiety and affective disorders) after traumatic birth experiences and elucidation of salient~     risk factors in the local population sample- by prospective follow-up.~   "
91421|NCT02370563|"~     The aim of this study is to explore the efficacy of 18F-FSPG in the detection of primary or~     metastatic brain cancer lesions confirmed by a standard of truth, preferably histology. This~     is a single center, open labelled, non-randomized study. A total of 30 subjects with brain~     tumor or brain metastases will be enrolled. All different stages of malignancies will be~     recruited, including those with different types of pathologies and grades, and newly~     diagnosed or recurrent disease.~   "
91422|NCT02370550|"~     The purpose of this large multicenter, randomized, double-blinded, controlled clinical study~     is to investigate the efficacy and safety of Cyclosporin A for primary Sjogren's syndrome~     associated pneumonitis(pSS-IP), which has important implications for the establishment of~     standardized diagnosis and treatment of pSS-IP.~   "
91423|NCT02370537|"~     This study is a 2-part open-label, randomized, crossover, multicenter, non-therapeutic Phase~     II study to investigate the presence of pancreatic exocrine insufficiency (PEI) in patients~     with Type 2 diabetes mellitus (T2DM), and to investigate the pharmacokinetics (PK) of~     EPANOVA® (omega-3 carboxylic acids) and omega-3-acid ethyl esters (OMACOR®, Abbott Healthcare~     Products Ltd) following a single oral dose in patients with different degrees of PEI.~   "
91424|NCT02370524|"~     The primary objective of this exploratory imaging study is to further characterize [18F]T807,~     an investigational PET radioligand for imaging Tau (thought to be a downstream biomarker~     indicative of neurodegeneration in conditions such as AD).~   "
91425|NCT02370511|"~     The purpose of this trial is to establish the safety and feasibility of the Edwards SAPIEN~     XT™and SAPIEN 3™ device and delivery systems in patients with severe symptomatic calcific~     mitral valve disease with severe mitral annular calcification who are not candidates for~     standard mitral valve surgery.~   "
91426|NCT02370498|"~     This is a study for participants with advanced gastric or gastroesophageal junction~     adenocarcinoma who have had tumor progression after first-line treatment with platinum and~     fluoropyrimidine doublet therapy. The primary study hypotheses are that pembrolizumab~     (MK-3475) prolongs progression free survival (PFS) and overall survival (OS) for participants~     with tumors that show positive programmed cell death ligand 1 (PD-L1) expression.~      As of 20-March-2016, enrollment will be limited to PD-L1 positive participants.~   "
91427|NCT02370485|"~     The purpose of this study is to evaluate how much of the LY2801653 drug is available in the~     body when given in 2 different formulations with and without a meal to healthy participants~     who are not able to have children. In addition, this study will measure how much of the drug~     gets into the blood stream and how long it takes the body to get rid of it. Information about~     any side effects that may occur will also be collected. The study will last about 27 days.~     Screening is required within 28 days prior to the start of the study.~   "
91428|NCT02370472|"~     The use of Ultrasound Guided Regional Anaesthesia (USRA) has increased over the last decade.~     Theoretically, ultrasound imaging may increase efficacy and safety by allowing visualization~     of the needle pathway and local anaesthetic spread around the nerve. In addition to knowledge~     of anatomy and general principles of ultrasonography, USRA requires learning new skills such~     as image interpretation, needle-beam alignment, and needle trajectory tracking. The hand-eye~     coordination required during needle advancement requires practice to master because the~     needle must be properly aligned with the ultrasound probe in order to maintain the needle~     path in the beam at all times. Adding to the difficulty, hand and needle movements can occur~     in three axes, but an ultrasound image is seen in only two dimensions. Since the ability to~     acquire the necessary skills to perform USRA is subjective and not yet validated, it is~     difficult to recommend a single, effective training pathway.~      Currently, the only method of supervised training before performing an USRA procedure on an~     actual patient involves practicing needle insertion in a phantom or cadaver. Studies~     assessing the impact of learning using these methods are lacking. It is possible that some~     practitioners may choose alternative one-off learning methods. Such methods are not~     standardized and are thus difficult to evaluate.~   "
91438|NCT02370342|"~     This clinical trial studies a type of ultrasound called robot-assisted laparoscopic~     high-intensity focused ultrasound for performing thermal ablative therapy, or sound wave~     therapy, in treating patients with small kidney masses undergoing partial removal of the~     kidney. The robot-assisted ultrasound probe takes images of the kidney to help doctors locate~     the mass. The probe then uses high frequency sound waves to target and ablate (or destroy)~     the kidney mass, which may be a cancerous tumor or benign tissue. Surgery is then performed~     to remove the part of the kidney with the mass. Robot-assisted laparoscopic high-intensity~     focused ultrasound for thermal ablative therapy may be safer and help doctors see the tumor~     better when performing kidney surgery.~   "
91429|NCT02370459|"~     The University of North Carolina will test the effectiveness of the Centers for Disease~     Control and Prevention's AFIX model for increasing HPV vaccination coverage among~     adolescents. AFIX (Assessment, Feedback, Incentives and eXchange) consists of brief quality~     improvement consultations that immunization specialists from state health departments deliver~     to vaccine providers in primary care settings. Using immunization registry data, the~     specialist evaluates the clinic's vaccination coverage and delivers education on best~     practices to improve coverage. We will compare changes in HPV vaccination coverage before and~     after consultations for high-volume pediatric and family medicine clinics across three study~     conditions: traditional consultations (in-person group), virtual consultations (webinar~     group), or no consultations (control group). In each participating state, 30 clinics will be~     randomly assigned to each study arm, for a total of 90 clinics per state, or 270 clinics~     overall. The primary objective of this study is to compare the change in coverage for HPV~     vaccine initiation among 11-12 year old patients, from baseline to 6-month follow-up.~     Secondarily, we will compare the change in coverage for other vaccines and age groups.~   "
91430|NCT02370446|"~     The purpose of this study is to see if using the MedLog is helpful to patients. Since the~     investigators do not yet know if this MedLog is helpful, some patients will receive it and~     some will receive our standard of care. The investigators want to know whether providing~     patients with this additional information is helpful and if having this additional~     information about their treatment schedule has an effect on their quality of life.~   "
91431|NCT02370433|"~     Bowel care (BC) is a time-consuming and cumbersome activity of daily living for most~     individuals with SCI. Previous studies have reported that the average time to complete a BC~     routine is 45 minutes; 10-20% of SCI individuals report BC routines lasting for more than 1~     hour. In past studies, the investigators have shown that a medication called neostigmine can~     increase bowel activity and thus, promote bowel movement. The investigators have successfully~     used this medication with traditional and novel methods of colonoscopic preparations, and~     have shown that it improves the quality of these preparations. In this study, we would like~     to test the applicability of this medication to bowel care routines.~      The investigators believe that the addition of this medication to the beginning of regular~     bowel regiments will significantly decrease the time and effort needed to complete BC, thus~     improving patient perception of their BC routines and quality of life. SCI individuals~     followed by the James J Peters VA Medical Center (JJPVAMC) SCI Medical Service are admitted~     on a routine basis for inpatient respite care, therapy, and/or annual physicals. Such~     inpatient stays typically range in duration from 1 week to 3 weeks, during which the patient~     undergo BC routines assisted by the inpatient care team. BC routines are typically performed~     every other day, or thrice weekly (Monday, Wednesday, Friday) in Blue Rooms located on the~     inpatient SCI wards (IE and ID). The bowel care routine, including duration of procedure, use~     of assistive medications or devices, and completeness of bowel care are documented in the~     patients' electronic medical chart (CPRS) by care providers. The investigators propose to~     perform the described protocol in individuals who have been admitted to the hospital for~     routine care and are otherwise healthy. In doing so, the investigators can ensure that~     patients are vigilantly monitored during each BC session, and that any changes in BC pattern~     are accurately observed and documented. Furthermore, by performing these procedures on an~     inpatient basis, study investigators can ensure the consistency of care and daily routine,~     allowing for better control of study conditions.~   "
91432|NCT02370420|"~     The investigators include patients attending the outpatient clinic in the area of Orthopedics~     and Traumatology of the investigators hospital with a diagnosis of knee osteoarthritis, which~     treatment is medical. Patients will be divided into two groups. In both groups, they will be~     given verbal, clear and detailed information on the approach to follow, the intra-articular~     application of Platelet-Rich Plasma in the knee, plus rehabilitation exercises. In the first~     group will be held single application, while in the second group three applications will be~     made at an interval of two weeks each. Both groups will be assessed before and after~     application, together with outpatient follow-up by the SF-12 Health Survey (SF-12), Western~     Ontario and McMaster Universities Arthritis Index (WOMAC) and Visual Analogue Scale (VAS).~   "
91433|NCT02370407|"~     This is a randomized controlled trial that will randomize 40 surgical skill naive medical~     students to practice on a robotic simulator or laparoscopic simulator after first completing~     a baseline evaluation on both surgical simulation platforms. Medical students will be~     evaluated again after 10 practice sessions on the laparoscopic or robotic platforms to assess~     transferability of skills between the surgical simulation platforms.~   "
91434|NCT02370394|"~     The study developed and assessed an innovative, high-reach, easily implementable, low-cost~     computer-delivered intervention (Reach out for a Safe Environment; ROSE Program) that~     addressed known barriers in early identification and intervention with perinatal women with~     IPV seeking treatment for mental illness.~   "
91435|NCT02370381|"~     Nose bleeding (epistaxis) is a common emergency. It is often difficult to estimate blood loss~     and the current hemoglobin of patients. In patients with oral anticoagulation, it is~     important to measure the level of hemodilution. Several situations with the importance of the~     fast determination of these parameters have been identified in previous studies [1,2]. The~     blood sampling from the venous punction is the standard in these investigations. However,~     this requires the corresponding painful puncture and also the time required at the~     laboratory.~      Since many patients present themselves with active bleeding, it is obvious that this blood~     could be used for determining the following parameters: Hemoglobin and INR/Quick. The nose~     blood can be analyzed with commercial rapid test devices. If these devices could generate~     same or similar results and after further validation of the method, painful punctures could~     be waived.~   "
91436|NCT02370368|"~     This study will examine the effects of six week dance training, using the Xbox Kinect Just~     Dance 2014 programme, on the agility scores along with general and hamstring flexibility and~     extensibility of the hip flexor. The effects of the dance programme will be compared with~     those of proven agility training techniques (ladder drills).~   "
91437|NCT02370355|"~     This research trial studies molecular characterization of circulating tumor cells (CTCs) and~     circulating tumor (ct) deoxyribonucleic acid (DNA) in blood and plasma samples from patients~     with prostate cancer that has spread to other places in the body and/or has not responded to~     previous treatment with hormones. Studying samples of blood and plasma collected from~     patients with prostate cancer before, during, and/or after treatment in the laboratory may~     help doctors learn more about changes that occur in DNA and identify the development of drug~     resistance.~   "
91439|NCT02370329|"~     This pilot phase II trial studies P1101 (polyethyleneglycol [PEG]-proline-interferon~     alpha-2b) in treating patients with myelofibrosis. PEG-proline-interferon alpha-2b is a~     substance that can improve the body's natural response and may slow the growth of~     myelofibrosis.~   "
91768|NCT02365987|"~     The purpose of this study is to investigate whether there are differences in postprandial~     metabolic indices following interesterified fats used in commercial spreads versus the~     corresponding un-interesterified blend.~   "
91440|NCT02370316|"~     The present randomised clinical trial aims to assess the clinical and neurobiological changes~     following Metacognitive Interpersonal Therapy -standard approach (MIT-SA) compared with~     Clinical Structured Treatment (CST) derived from specific recommendations in APA guidelines~     for borderline personality disorder (BPD). The investigators will assess clinical changes in~     metacognitive abilities and in emotion regulation and changes in brain activation patterns at~     the resting state and while they view emotional pictures. A multidimensional assessment will~     be performed at the baseline, at 6, 12, 18 months. The investigators will take structural and~     functional Magnetic Resonance Images (MRIs) in MIT-Treated BPD (N=30) and CST-treated BPD~     (N=30) at baseline and after treatment, as well as a group of 30 healthy and unrelated~     volunteers that will be scanned once for comparison. Furthermore, blood analyses will be done~     in order to assess level of BDNF and some hormone levels (oxytocin and vasopressin) before~     and after treatments.~   "
91441|NCT02370303|"~     The purpose of this study is to isolate and measure circulating tumor cells in the blood~     stream to advance detection of cancer and treatment monitoring. In this study, the~     investigators will utilize the novel technology for circulating tumor cell detection in order~     to evaluate their presence in patients with lung cancer.~   "
91442|NCT02370290|"~     This pilot research trial studies quantitative imaging metrics derived from contrast enhanced~     computed tomography (CECT) in enhancing assessment of disease status in patients with kidney~     cancer. Quantitative imaging is the extraction of quantifiable features from radiological~     images for the assessment of disease status. Collecting quantitative imaging metrics from~     CECT imaging may help doctors predict tumor aggressiveness and nuclear grade (tumor stage)~     and assess treatment response and prognosis in cancer imaging.~   "
91443|NCT02370277|"~     This pilot research trial studies the effects of chemotherapy on intestinal~     bacteria/organisms (microbiota) in patients newly diagnosed with breast cancer. Change in~     intestinal microbiota may be associated with weight gain in patients treated with~     chemotherapy. Weight gain has been also associated with cancer recurrence. Examining the~     types and quantity of bacterial composition in the stool of breast cancer patients treated~     with chemotherapy may help determine whether body weight and composition are associated with~     changes in the intestinal microbiota and allow doctors to plan better treatment to prevent~     weight gain and possibly disease recurrence.~   "
91444|NCT02370264|"~     This pilot clinical trial studies questionnaires in identifying arms, shoulder, and neck~     (upper extremity) function and quality of life after treatment in patients with breast~     cancer. Patients may experience arms, shoulder, and neck impairments that negatively affect~     their functioning and quality of life after cancer-related treatment. Studying upper~     extremity function and quality of life in patients after breast cancer treatment may help~     doctors determine the prevalence and severity of long-term functional impairments and the~     relationship between the perception of impairments due to breast cancer treatment and its'~     impact on quality of life.~   "
91445|NCT02370251|"~     This is a single-assignment study to evaluate whether Omegaven (IV fish oil) is effective at~     treating liver disease in children on long-term IV nutrition.~   "
91446|NCT02370238|"~     Reparixin oral tablets are being tested as a CSC targeting agent in patients with metastatic~     non- human epidermal growth factor receptor (HER2)-amplified BC. An open label Phase 1b~     clinical study (REP0111) is ongoing (enrollment completed) in five US sites, under IND #~     112502, to test safety, tolerability, pharmacokinetics and detect early signs of antitumor~     activity of increasing doses of reparixin oral tablets in combination with a fixed dose of~     weekly paclitaxel. The study has demonstrated safety and tolerability of the combination~     across the three dose levels explored and recorded objective responses in the published range~     for single agent weekly paclitaxel in the target population. The highest dose level explored~     (i.e., 1200 mg t.i.d.) was identified as the recommended phase 2 dose. Durable responses have~     been recorded in patients with TNBC.~      The current phase 2 study thus aims to evaluate the Progression Free Survival of patients~     with metastatic TNBC [newly diagnosed metastatic or relapsed following (neo)adjuvant~     chemotherapy] receiving reparixin in combination with paclitaxel versus paclitaxel alone.~   "
91447|NCT02370225|"~     The purpose of this sudy is to investigate the effects of a regular aerobic exercise on~     aerobic capacity, fatigue, depression, quality of life, perception of symptoms and disease~     activity in women with pSS.~   "
91448|NCT02370212|"~     Recent evidence suggests that high -intensity interval training (HIIT) may be an effective~     strategy to improve cardiorespiratory fitness, exercise performance, and insulin sensitivity.~     In addition, creatine (Cr), a nitrogen- containing compound, is widely used to enhance high~     intensity exercise performance. A seminal study demonstrated that the muscle content of Cr~     and phosphocreatine (PCr) can be elevated by exogenous Cr. Oral intake of Cr increases the~     concentration in blood and muscle, and part of the increased muscle Cr is transformed to PCr~     (a process catalyzed by Cr kinase). Cr supplementation increases total Cr (TCr = Cr + PCr) by~     ~20%, with the PCr component accounting for 10% of the increase.~      Combining HIIT and Cr is intriguing for two reasons; first, Cr supplementation improves~     performance through increasing PCr, PCr recovery, and muscle buffering which may facilitate~     higher training intensities and therefore greater training adaptations. Secondly, both Cr and~     HIIT have individually been shown to increase GLUT 4 and insulin sensitivity, suggesting that~     Cr supplementation may be an adjunct to HIIT for improving glucose control. To date, there~     have only been two studies investigating the performance effects of Cr combined with HIIT~     with preliminary positive results. No studies have examined the impact of combined Cr + HIIT~     on outcomes related to insulin sensitivity. Therefore, the purpose of this research is to~     examine the combined effects of Cr and HIIT on performance and insulin sensitivity as~     determined via an oral glucose tolerance test (OGTT) in young healthy adults.~   "
91449|NCT02370199|"~     This study evaluates 670 nm energy in the form of red light to stimulate blood flow changes~     in healthy adults. All participants will receive red light to their leg. They will also~     receive a continuous infusion of Definity (octafluoropropane) ultrasound contrast.~   "
91471|NCT02369900|"~     The main purpose of this study is to determine the effects of controlling the heart rate of~     patients with septic shock using an intravenous medication called esmolol.~   "
93679|NCT02340949|"~     This trial compares induction treatment with FOLFOX with or without aflibercept in a high~     risk population selected by MRI, prior to receiving standard chemoradiation (capecitabine~     combined with 50.4 Gy in 28 days) and surgery, in order to evaluate the efficacy in terms of~     pCR.~   "
91450|NCT02370186|"~     Severe sepsis results in over 300,000 Emergency Department (ED) visits and 215,000 deaths~     annually in the US. Currently there are no effective drug therapies for sepsis. High density~     lipoprotein (HDL) has antioxidant, anti-inflammatory, and antithrombotic properties and is~     protective in sepsis. Its functions in sepsis are primarily mediated by its main~     apolipoprotein, Apo-A1, that: 1) neutralize potent bacterial toxins, 2) protect blood vessel~     walls from damage, 3) prevent tissue damage through antioxidant properties, and 4) mediate~     thymocyte apoptosis (critical for survival) and endogenous corticosteroid release. However,~     recent literature presents inconsistent data on HDL functionality and shows that HDL becomes~     non-functional during acute inflammatory states called dysfunctional HDL (Dys-HDL). Several~     causes for Dys-HDL have been hypothesized including the presence of Apo A1 polymorphisms,~     which may worsen the pathologic inflammatory response in sepsis and have been demonstrated in~     early sepsis, making Dys-HDL an unstudied potential early marker. This project aims to: 1)~     determine the presence of Dys-HDL in adult patients with early severe sepsis who present to~     the ED (Dys-HDL will be tested using a novel cell free assay and HDL Inflammatory Index will~     be measured), and 2) examine the relationship between Dys-HDL and cumulative organ~     dysfunction via Sequential Organ Failure Assessment (SOFA) score. Results of this study could~     establish Dys-HDL as an early disease marker for sepsis which is influential in the~     development of sepsis-induced organ dysfunction.~   "
91451|NCT02370173|"~     Sleep disturbance is nearly ubiquitous among individuals suffering from PTSD and is a major~     problem among service members returning from combat deployments. The proposed study aims to~     test a novel, inexpensive, and easy to use approach to improving sleep among service members~     with PTSD.~      Primary outcome measures will include not only PTSD symptom improvement but also include~     neuroimaging of brain structure, function, connectivity, and neurochemistry changes. The~     proposal is firmly grounded in the emerging scientific literature regarding sleep, light~     exposure, brain function, anxiety, and resilience. Prior evidence suggests that bright light~     therapy is effective for improving mood and fatigue, and our pilot data further suggest that~     this treatment may be effective for improving daytime sleepiness and brain functioning in~     brain injured individuals. Thus, this intervention, in our own research and in the work of~     others, has been shown to affect critical sleep regulatory systems. Improving sleep may be a~     vital component of recovery in these service members. Our approach would directly address~     this issue. Our preliminary data have shown that this approach is extremely well tolerated~     and is effective for improving sleep, mood, cognitive performance, and brain function among~     individuals with brain injuries.~      Finally, the potential impact of this study is high because of the capability of~     transitioning the research to direct clinical application almost immediately. If the bright~     light treatment is demonstrated as effective, this approach would be readily available for~     nearly immediate large-scale implementation, as the devices have been widely used for years~     in other contexts, are already safety tested, and commercially available from several~     manufacturers for a very low cost. Thus, the impact of this research on treating PTSD would~     be high and immediate.~   "
91452|NCT02370160|"~     This is a phase I/II study of DT2219 for the treatment of relapsed or refractory CD19 (+)~     and/or CD 22 (+) B-lineage leukemia and lymphoma. The study consists of two phases - a phase~     I dose/schedule finding component using the maximum tolerated dose identified during the~     previous phase I study, but with a higher number of doses and a two-stage phase II extension~     component to confirm safety and make a preliminary determination of the activity level by~     disease using the dose identified in phase I.~   "
91453|NCT02370147|"~     A two-arm randomized controlled trial for smokers who are not intent to quit smoking will be~     proposed in outpatient department clinics of People's Liberation Army General Hospital in~     Beijing, China. Smoking reduction intervention arm (SRI) consisting of a very brief~     face-to-face individual smoking reduction intervention lasted about one minute, and five~     follow-up interventions lasted for about minute each. Control arm (EDA) consisting of a very~     brief face-to-face individual exercise and dietetic advices lasted for the same intervention~     time as SRI, and also five follow-up interventions lasted for one minute each with different~     intervention contents.~   "
91454|NCT02370134|"~     This study is aimed to study the feasibility and safety of parkinson's glove that combined 2~     module of tremor detection and tremor suppression with electrical muscle stimulation for~     using as device for rest tremor suppression in parkinson's disease patients~   "
91455|NCT02370121|"~     Gymnema sylvestre has demonstrated promising effects in the treatment of obesity,~     dyslipidemia, hypertension, insulin secretion, among others. The above mentioned findings~     show that Gymnema sylvestre has an excellent potential for the prevention and treatment of~     metabolic syndrome.~   "
91456|NCT02370108|"~     This study is aimed to study the safety and feasibility of electrical muscle stimulation~     (EMS) in suppression of tremor from various causes especially for rest tremor in Parkinson's~     disease.~   "
91457|NCT02370095|"~     Acute Respiratory Distress Syndrome (ARDS) is a rapidly progressing lung disease caused by a~     number of factors including pneumonia, sepsis and acute trauma that leads to reduced lung~     function and breathlessness. There are no pharmacological treatments approved for the~     treatment of ARDS. This pilot trial will study the safety and efficacy of Treprostinil sodium~     by inhalation for preventing the progression of acute hypoxemic respiratory failure to~     positive pressure ventilation and/or ARDS in patients at high risk.~   "
91458|NCT02370082|"~     The purpose of this study is to evaluate the performance of the SAVI SCOUT® Surgical Guidance~     System (SAVI SCOUT). The SAVI SCOUT is a medical device, used to provide real-time guidance~     during localized excisional biopsy or lumpectomy procedures, by helping the surgeon locate~     and remove the desired tissue (i.e., the lesion and surrounding normal tissue). The SAVI~     SCOUT has been 510K cleared.~      The SAVI SCOUT is intended to assist surgeons in the location and retrieval of a non-palpable~     abnormality as localized by radiographic or ultrasound methods. In this study, the ability of~     the SAVI SCOUT to guide surgeons to find a lesion will be evaluated instead of the standard~     technique of wire localization.~   "
91472|NCT02369887|"~     This is a prospective observational cohort study that aims to enroll a total of 2000 Thai MSM~     and TG at five health facilities in four provinces of Thailand. Each participant will be~     followed for 18 months. Baseline and historical rates of HIV testing/re-testing, initial CD4~     counts, retention in care, and ART adherence at the study clinics, at the study clinics~     combined, and national data (if available) will be compared with rates after implementation~     of the Test and Treat strategy. Analysis will also include an assessment of HIV prevalence~     and incidence. This study will use similar objectives, indicators, and procedures as those~     used in an ongoing Test and Treat study by the Thai Red Cross AIDS Research Centre in three~     tertiary care hospitals, and a study to be conducted with PEPFAR Key Populations~     Implementation Science (KPIS) funding through United States Agency for International~     Development (USAID), in community-based centers, allowing comparison of uptake and follow-up~     of MSM and TG using the Test and Treat strategy in a variety of settings.~   "
91459|NCT02370069|"~     Patients with severe chronic kidney disease (CKD) are at a great risk for infection due to~     their immune system being suppressed. Pneumococcal infection is particularly common and often~     results in death due to inflammation of lung (pneumonia) or the whole body (sepsis). This~     infection can be prevented using vaccines which help build protective immunity. The currently~     recommended pneumococcal vaccine (Pneumovax), however, is often inefficient in this group of~     patients. There is thus an urgent need to improve the existing vaccination policy.~      The goal of this research is to optimize pneumococcal vaccination of patients with severe~     CKD. Many patients suffering from CKD have already been vaccinated with Pneumovax. Because~     this vaccine has low immunogenicity in immunocompromised individuals, they may still develop~     infection. A new vaccine, Prevnar13, has superior immunogenicity and has been recently~     approved for immunization. There is, however, no specific policy regarding immunization of~     adult CKD patients, and it is furthermore unknown whether previous Pneumovax immunization~     negatively affects immune response to Prevnar13.~      In order to test whether previous immunization with Pneumovax affects the immune response of~     severe CKD patients to Prevnar 13, the investigators will immunize two groups of adult stage~     4 and 5 CKD patients with one dose of Prevnar 13 and will assess their initial immunological~     response, its longevity, and vaccine safety. The first group will consist of patients who had~     been previously immunized with Pneumovax, and the second group will include participants with~     no history of pneumococcal vaccination.~      Antibody levels and opsonophagocytic activity (OPA) will be quantified. The longevity of the~     immune response will be assessed. As a secondary objective, the immune response will be~     analyzed in the context of demographic and clinical characteristics of the vaccinated~     participants.~   "
91460|NCT02370056|"~     The anticipated advantages of 3D laparoscopic visualization for the surgeon are greater~     accuracy and speed in manual skills, translating to decreased operative time, reduced~     learning curve, and superior safety.We aimed to determine the feasibility of the laparoscopic~     approach using 3D visualization in the surgical treatment of ulcerative colitis~   "
91461|NCT02370043|"~     The purpose of this study is to assess the safety, tolerability, and the effect of food on~     KQ-791. Each participant may receive up to 3 single doses of KQ-791 (at up to 3 different~     dose levels) and 1 placebo dose over the course of the study. Up to 6 escalating dose levels~     may be studied, in two distinct groups or cohorts.~   "
91462|NCT02370030|"~     Triple blind placebo-controlled study to determine if administering citrulline in patients~     with sepsis and severe sepsis slows progression to multiple organ failure and death,~     measuring biomarkers of endothelial dysfunction. Patients are divided into placebo or~     citrulline and followed up for 1 month.~   "
91463|NCT02370017|"~     The object of this study is to identify the combined effect of ANKL and doublet chemotherapy~     in advanced NSCLC. The investigators design the combination of ANKL and approved chemotherapy~     as the 3rd and 4th courses in the patients who get stable response after x2 induction as the~     first line chemotherapy. ANKL (2x10*9) from peripheral blood 32ml is administered rapidly iv~     12-36hr after each chemotherapeutic agents while peak effect of NK cell ligand modulation by~     chemotherapeutic agent is maintained. After 4th course, response evaluation is done by~     Response Evaluation Criteria in Solid Tumors (RECIST) and 40% or more partial response (PR,~     increased by 15% or more from historical control 25%) is the expected target and Simon's two~     stage design will be applied through the study (power 80%, a= 0.95, N1= 33, N= 68)~   "
91464|NCT02370004|"~     The aim of the study is proof of concept and to establish the feasibility of performing a~     study of resistive flexibility and strength training (RFST) in patients with asthma, with the~     future goal of designing a larger randomized trial to test the hypothesis that RFST leads to~     greater improvement in asthma symptoms, pulmonary function tests, range of motion and~     connective tissue mobility compared with a control conventional physical therapy~     intervention.~   "
91465|NCT02369991|"~     This study assesses the long-term results of compound tibial reconstruction treated with a~     microvascular latissimus dorsi flap and bone transport technique during the last 25 year in~     Helsinki University central Hospital.~   "
91466|NCT02369978|"~     This randomized, blind, parallel-group trial will evaluate the efficacy and safety of~     Nifurtimox (NFX) and Benznidazole (BZN), the two usual interventions to treat the parasite~     Trypanosoma cruzi.~      The investigators will test whether NFX is an effective trypanocidal agent (by comparison~     with placebo) and equivalent to BZN (as active comparator) in terms of both parasite-related~     and safety outcomes.~      Individuals found seropositive and without clinical signs of dilated cardiomyopathy will~     receive either of the active treatments or matching placebo. Participants allocated to NFX or~     BZN will receive either a 60-day (full-dose) or a 120-day (half-dose) active treatment,~     whereas the control group will receive placebo for 120 days. There will be thus four arms of~     active treatment (NFX60, NFX120, BZN60 and BZN120), and a fifth control arm receiving placebo~     (1:1:1:1:1 allocation ratio) where every participant in the trial will take 120 days of study~     drug (the groups receiving full-dose will complete a 120-day masked treatment with placebo).~      The study plans to enroll 500 participants from Colombia (in two different geographical~     areas) and Argentina, in order to explore regional differences in the treatment effects.~   "
91467|NCT02369965|"~     The purpose of this study is to determine the efficacy and safety of albuvirtide plus~     lopinavir-ritonavir in HIV-1-infected adults who failed first-line antiretroviral therapy.~   "
91468|NCT02369939|"~     Randomized study to investigate the efficacy of deep regional hyperthermia in patients with~     anal carcinoma treated by standard radiochemotherapy with MMC and 5-FU.~   "
91469|NCT02369926|"~     This study aims to calibrate the Multiple Sclerosis Functional Composite (MSFC) for home~     implementation in a phase 2 trial of lisinopril in multiple sclerosis. In this initial stage,~     participants are required to travel to the study site one day a week for three weeks to~     complete the MSFC. They are also required to complete the MSFC at home once weekly for three~     weeks using remote sensing technology and video conferencing.~   "
91470|NCT02369913|"~     This proposal is designed to test the hypothesis that humans shift to reliance on ketone~     bodies as a cardiac fuel source during the development of HF. The investigator also propose~     that this shift to ketone utilization can be detected by metabolomic profiling of blood.~      Specific Aim 1: To determine if the failing human heart exhibits increased extraction of~     blood-borne ketone bodies. Ketone bodies will be measured in coronary sinus, arterial, and~     central venous blood samples to determine AV differences. The HF group will be comprised of~     patients undergoing cardiac resynchronization therapy with an implantable~     cardioverter-defibrillator. The Control group will be compromised of patients without~     evidence of structural heart disease who are undergoing catheter ablation for~     supraventricular tachycardia.~      Specific Aim 2: To determine whether blood samples from humans with HF display metabolomic~     signatures indicative of increased myocardial ketone body utilization. Quantitative targeted~     metabolomics will be performed on the samples described in Aim 1 to determine if metabolite~     markers (e.g. C4-OH acylcarnitine, acetylcarnitine, succinate) found to be associated with~     increased myocardial ketone body oxidation in animal models are increased in the human HF~     group compared to the controls.~   "
91474|NCT02369861|"~     Subjects with moderate-to-severe Dry Eye by symptoms will be screened including history,~     ophthalmic examination to include the status of their ocular structure and function and~     evaluation of tear production. Blood will be blood drawn for complete blood count and~     chemistry panel. They will also have a urinalysis and pregnancy test in women of~     child-bearing potential.~      Subjects will have a two week run-in period in which they use artificial tears. If their~     Dry Eye signs and symptoms do not improve significantly, they will be enrolled and will~     receive study drug.~      Safety evaluation includes assessment of the structure and function of the eyes including~     retina examination and corrected visual acuity.~      Subjects who meet the inclusion and exclusion criteria will be randomly assigned to one of~     two treatment arms, ACCS or artificial tears eye drops. The randomization scheme is 1:1~     ACCS:artificial tears. Subjects will self-administer their eye drops four times each day.~      Subjects will be seen in the office of the ophthalmologist/optometrist at baseline (week~     zero), one week, three weeks, six weeks and ten weeks. Eye examination will be done at each~     visit. The baseline eye tests and lab work will be repeated after the treatment phase of the~     study at the end of week six. Following 6 weeks of treatment, the subjects will be followed~     for 4 additional weeks.~   "
91475|NCT02369848|"~     Shockwave Medical, Inc. intends to conduct a prospective, single-arm, multi-center, clinical~     study designed to evaluate the safety and performance of the Shockwave Lithoplasty™ System in~     subjects with moderate to heavily calcified peripheral arteries with 3.50mm to 7.0mm~     reference vessel diameter at the target site. The Shockwave Lithoplasty™ System is indicated~     to generate sonic shockwave energy within the target treatment site and disrupt calcium~     within the lesion to allow for subsequent dilation of a peripheral artery stenosis using low~     balloon pressure. Up to sixty (60) subjects will be enrolled and treated with Lithoplasty to~     yield thirty (51) evaluable subjects complete the study assuming a 15% lost to follow-up~     rate.~   "
91476|NCT02369835|"~     This randomized phase III trial studies how well modified Dakin's solution works in reducing~     radiation-induced dermatitis, a common skin reaction to radiation therapy, in patients with~     head and neck cancer undergoing radiation therapy. Modified Dakin's solution may reduce~     inflammation in the body, which may prevent or reduce dermatitis after radiation therapy.~   "
91477|NCT02369822|"~     There are no solid treatment guidelines for idiopathic intractable epilepsy in children. The~     investigators propose that vitamin C being an antioxidant will improve seizure frequency and~     EEG in children with idiopathic intractable epilepsy.~   "
91478|NCT02369809|"~     Aim of the study is to gain more knowledge about efficacy and safety of Neovasculgen® in~     daily clinical practice and obtain information about the quality of life in patients treated~     with Neovasculgen®.~   "
91479|NCT02369796|"~     The purpose of this study is to evaluate the effects on serum testosterone after 4 weeks of~     subcutaneous (SC) dose administration, with different doses and dosing frequencies of TAK-448~     to overweight/obese males with hypogonadotropic hypogonadism.~   "
91480|NCT02369783|"~     The main objective of the study is to validate a methodology with Psychometric tool to~     measure levels of patients social fragility.~      This tool will be dematerialized on a tablet. The answers will be then processed by a~     decision support algorithm, which automatically send an alert to detection of social~     fragility of the patient to the nurse navigators.~   "
91481|NCT02369770|"~     Early after stroke, patients often have significant motor impairment and sensory deficit.~     Evidence has demonstrated heightened plasticity and significant recovery in the acute phase~     (first months) post stroke but there has been a lack of effective and practical protocols and~     devices for early intensive sensorimotor therapy.This research study will conduct a~     randomized clinical trial of an intensive motor-sensory rehabilitation on patients with acute~     stroke using a wearable rehabilitation robot. The primary aims are to facilitate sensorimotor~     recovery, reduce ankle impairments, and improve balance and gait functions. This clinical~     trial will be conducted on the Study and Control groups of acute stroke survivors.~   "
91482|NCT02369757|"~     The main objective is to evaluate the impact of the recruitment and training of a~     peer-navigator on the participation rate of colorectal cancer screening among underserved~     area. The role of the navigator is to establish an intervention culturally-tailored to the~     inhabitants in order to promote the Fecal Occult Blood test (FOBT) and accompany the~     inhabitants to complementary exams, if needed.~   "
91483|NCT02369744|"~     Ureteral calculi, commonly known as kidney stones, are a frequent cause of Emergency~     Department (ED) visits. These stones can get caught in the ureter (the tube connecting the~     kidney to the bladder) and cause symptoms including pain, nausea, and vomiting. As long as~     the obstructing stone meets certain conditions and the patient isn't too sick, the patient is~     usually sent home to try and pass the stone without surgery. This treatment is known as~     medical expulsive therapy (MET), and routinely involves the use of a drug called tamsulosin,~     which relaxes the smooth muscle of the urinary system to help the stone pass. Silodosin is a~     drug in the same class of tamsulosin, but which is thought to have a more selective action~     and a quicker onset, which would theoretically make it better for aiding in kidney stone~     passage. The purpose of this study is a head-to-head, blinded comparison of these two drugs~     to see how quickly they result in stone passage. Subjects are patients presenting to the ED~     with acute kidney stone shown by CT scan, and who are appropriate for MET. The main study~     intervention is randomization to receiving either tamsulosin or silodosin. The hypothesis is~     that silodosin will have decreased time to stone passage compared to tamsulosin.~      Subjects who qualify and consent are randomized to a two-week course of either silodosin or~     tamsulosin. They are also given prescriptions for standard of care medications for pain and~     nausea, as well as a pain diary. They receive a follow-up phone call after one week to remind~     them of their follow-up appointment, ask about adverse events, and determine if their stone~     has passed. They have a follow-up visit with study staff at the end of their two week~     treatment to collect their pain diary, pill count, adverse events, and to determine if their~     stone has passed. Study participation ends after this follow-up visit.~   "
91484|NCT02369731|"~     This study is being performed as a post-approval safety study (PASS), per the~     Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA), to~     gather data on Translarna (ataluren) safety, effectiveness, and prescription patterns in~     routine clinical practice.~   "
91485|NCT02369718|"~     Cochlear implant microphones are subject to aging and dirtying. The evolution may affect~     their efficiency. Several signal coding strategies are used in cochlear implants and their~     behaviour may be more or less affected by the aging process. In this work the investigators~     wish to assess this phenomenon.~   "
91793|NCT02365662|"~     This is an open-label, Phase I, dose escalation study to determine the recommended Phase 2~     dose, maximum tolerated dose, and evaluate the safety and pharmacokinetic profile of ABBV-221~     in participants with advanced solid tumors likely to exhibit elevated levels of Epidermal~     Growth Factor Receptor (EGFR).~   "
91486|NCT02369705|"~     Subjects with cardiac disorders will be tested in the sleep laboratory with a conventional~     full-night PSG recording along with WP 200/WP200U ambulatory sleep diagnostic device in a~     synchronized manner.~      The PSG data will be scored manually by a trained polysomnographic scorer, according to~     standard criteria for this clinical routine.~      The data obtained by the WP200/WP200U will be analyzed automatically for RDI, AHI, sleep~     stages, snoring (optional) and body position (optional), in addition to parameters specific~     to cardiac subjects. The analysis will be performed by the WP200/WP200U software (zzzPAT) and~     will be compared to the PSG's manual scoring which serves as a Gold Standard.~   "
91487|NCT02369692|"~     The purpose of this prospective study is to gather procedural use and safety data on the~     initial use of the Magellan Robotic System with the Magellan Robotic Catheter 6 Fr, Vascular~     Accessories 6 Fr and Microcatheter Driver This study will focus on, but not be limited to,~     endovascular embolization procedures in the peripheral vascular, for example, embolization of~     the splenic and hepatic arteries, uterine arterial embolization (UAE), prostatic arterial~     embolization (PAE), and trans-arterial chemoembolization (TACE).~      The data will be analyzed for medical education, societal presentation and/or publication by~     the investigator.~   "
91488|NCT02369679|"~     Treatment of lymphedema is based on a combined program called complex decongestive therapy.~     The components of the complex decongestive therapy are skin care, kinesiotherapy, manual~     lymphatic drainage and compression. The compression with multilayer bandage has proved to be~     the most effective of these therapies when analyzed separately.The multilayer bandage~     produces a gradient compression on the limb where distal pressure is higher than proximal~     pressure. Several materials are needed for the multilayer bandage, including tubular bandage~     lining, digit bandages, foam under-cast padding and multiple layers of short-stretch bandages~     to cover the entire limb. The Precast Adjustable Compression Wrap fits each patient through a~     Velcro system.~      The aim is to compare the effectiveness of a precast adjustable compression wrap (Circaid)~     with the multilayer compression bandages in the treatment of the upper limb lymphedema.~   "
91489|NCT02369666|"~     The primary purpose of this study is to determine if 4-weeks ingestion of LycoRed (code~     40051) product containing a mixture of tomato extract with carotenoids and phytochemicals by~     endurance runners attenuates inflammation, muscle damage and soreness, and oxidative stress~     during 24 hours recovery from a 2-h running bout.~   "
91490|NCT02369653|"~     The purpose of this study is to compare the effect of a blood thinning drug called Apixaban~     versus no administration of a blood thinning drug, in preventing blood clots in children with~     leukemia or lymphoma. Patients must be receiving chemotherapy, including asparaginase, and~     have a central line (a catheter inserted for administration of medications and blood~     sampling).~   "
91491|NCT02369640|"~     During the past decades, simulation-based training has become essential for making trainees~     fit for clinical practice. Traditionally, trainees are instructed to practice with as few~     errors as possible during simulation-based training. However, recent evidence from the field~     of psychology suggests that transfer of learning may improve if trainees are encouraged to~     commit errors during training. The aim of this study is to assess on performances with real~     patients the effect of error-management instructions compared to error-avoidance instructions~     during simulation-based virtual reality ultrasound training.~      This study is planned as a randomized controlled trial. Participants include medical students~     with no prior simulation practice at the fifth or sixth year of medical school. All~     participants receive 3 hours simulation-based ultrasound training focusing on fetal weight~     estimation. The participants (N=60) are randomized into two groups: Participants in group 1~     are instructed to follow the simulator program step-by-step to achieve the highest possible~     simulator metric scores by making as few errors as possible. Participants in group 2 are~     instructed to experiment and explore and to deliberately make errors during training. A~     simulation-based pre- and post-test is administered before and after training.~      Participants are scheduled to perform a transfer test seven to ten days after simulation~     training. The transfer test consists of fetal weight estimation on a real patient. The~     primary outcome is weight deviation of participant measurements compared to expert findings.~     Secondary outcomes include performance assessments of pre-, post- and transfer test~     performances by blinded ultrasound experts using the Objective Structured Assessment of~     Ultrasound Skills (OSAUS) scale. Using an alpha level of 0.05, an effect size of 0.80, and a~     power of 0.80, 25 participants are needed in the two study groups. Loss to follow-up of up to~     20% of study participants is anticipated, resulting in 30 participants in each study group.~   "
91492|NCT02369627|"~     The purpose of this study is to evaluate a new approach to increase HIV testing among young~     adult Black, Hispanic, and white men-who-have-sex-with-men (MSM). In this randomized,~     controlled trial, participants will be assigned to one of three HIV testing groups: (1) rapid~     HIV self-testing group (OraQuick® In-home HIV Test), (2) conventional home-based HIV~     testing group (Home Access Express), and (3) community/medical-based HIV testing group. Upon~     completion of testing, participants will receive a questionnaire to evaluate their HIV~     testing experience, and also inquire about recommendations for future testing. Study~     participants will also have the option to refer other study eligible males to the study via~     email.~   "
91493|NCT02369614|"~     This is a randomized placebo/sham controlled, double-blind study investigating the efficacy~     of high- and low-frequency rTMS applied to the right DLPFC at either 1 Hz, 10 Hz, or sham~     rTMS as compared to an OASIS treatment as usual group for the treatment of PTSD symptoms.~   "
91494|NCT02369601|"~     Premature rupture of membranes refers to the rupture of the fetal membranes prior to the~     onset of labor. Premature rupture of membranes is associated with a number of neonatal and~     maternal complications including an increased incidence of perinatal mortality and~     intra-amniotic infection. There is a need for improved diagnostic testing because of~     limitations of the current methods.~      PRO-MComplete is an immunochromatographic test that detects insulin growth factor binding~     protein 1 and alpha-fetoprotein in vaginal fluid as an indicator of membrane rupture.~   "
91495|NCT02369588|"~     This study tests the effect of serving larger portions of all foods in a meal on the outcome~     of food and energy intake. Using a crossover design, participants are served the meal once a~     week for four weeks and the portion sizes are varied at each meal. Some of the foods served~     at the meal are low in calorie density (calories per gram) and some are higher in calorie~     density. The aim is to determine whether intake in response to larger portions differs~     depending on characteristics of the subjects or of the foods.~   "
91496|NCT02369575|"~     The purpose of this study is to investigate new therapies for advanced lung disease.~   "
91497|NCT02369562|"~     The purpose of this retrospective study is to investigate and identify factors associated~     with the failure of dental implants within the population rehabilitated with dental implants~     at the Folktandvården Specialistklinik in Malmö (Spårvägsgatan 12, 214 27, Malmö).~   "
91794|NCT02365649|"~     To determine the efficacy and safety of multiple doses of ABT-494 in subjects with moderately~     to severely active Crohn's Disease with a history of inadequate response to or intolerance to~     Immunomodulators or anti-Tumor Necrosis Factor (TNF) therapy.~   "
91498|NCT02369549|"~     An investigator initiated pilot trial: two arm, double blind, placebo controlled, randomized,~     parallel group of approximately 750 patients with chronic kidney disease, and who have~     evidence of overt proteinuria, will be treated with micro-particle curcumin versus placebo~     over 24 weeks from start of the investigational medication date (approximately 6 months) to~     test whether curcumin can slow chronic kidney disease progression in patients. Three 30 mg~     capsules of micro-particle curcumin will be self-administered once daily in the morning to~     determine the the safety and efficacy of curcumin relative to placebo in reducing~     albuminuria, reducing urinary interleukin-18 and slowing the loss of eGFR.~   "
91499|NCT02369536|"~     The objective of this study is to provide clinical data to support the effectiveness of a~     mixture of ingredients of natural origin, suitably selected and packaged, in the protection~     from liver damage, in subjects with NAFLD.~      Study design: double-blind, randomized, multicentre trial, placebo-controlled on two parallel~     groups.~      The study participants are healthy volunteers, since they do not have nor had any~     liver-related clinical symptom, but simply laboratory (plasma levels greater than normal for~     at least one of the liver parameters -aspartate aminotransferase AST, alanine~     aminotransferase ALT or γ -glutamyltranspeptidase γ-GT) or instrumental (ultrasonographic~     abnormalities of steatosic liver) tests altered as compared to normal ranges.~      Three months treatment with the nutraceutical mixture or placebo. Outcomes tested before and~     at the end of treatment - 3 months).~   "
91500|NCT02369523|"~     The investigators plan to evaluate the length of time to discharge readiness between the~     groups (continuous femoral nerve blocks (cFNB) vs. liposomal bupivacaine (LB) vs.~     periarticular infusion cocktails (PIC) following primary total knee arthroplasty (TKA). In~     addition, the investigators will compare quadriceps strength recovery over time and~     exploratory variables between the groups.~   "
91501|NCT02369510|"~     The purpose of this study is to investigate whether the addition of a medication called~     epinephrine to spinal medications prolongs the duration of the anesthesia. The medication~     standardly used in spinal anesthesia is a local anesthetic (bupivacaine) and an opiate pain~     medication (morphine). These medications typically last about 2 hours. The investigators want~     to determine if adding epinephrine to the spinal medications prolongs the anesthetic without~     side effects. A longer duration of anesthesia may be useful in prolonged repeat cesarean~     section. Epinephrine is known to prolong the action of some local anesthetics, but the~     investigators want to specifically study combining it with the medications the investigators~     use regularly for cesarean section.~      You may qualify to take part in this research study because you are having a repeat cesarean~     section. Repeat cesarean sections sometimes last longer than 2 hours. The investigators want~     to determine if epinephrine will prolong the anesthetic.~   "
91502|NCT02369497|"~     This is a prospective study on the Ascension HRA device to collect data to assess the safety~     and effectiveness of the HRA.~   "
91503|NCT02369484|"~     The purpose of this study is to investigate the control of disease in pretreated patients~     with advanced non small cell lung cancer (NSCLC) harbouring HER2 exon 20 mutations as well as~     the safety and tolerability (how severe the side effects are) of the treatment with afatinib.~   "
91504|NCT02369471|"~     To evaluate the pharmacokinetics, safety and tolerability of GWP42006 compared with placebo,~     in the presence of other antiepileptic drugs (AEDs).~   "
91505|NCT02369458|"~     No agent is known to have efficacy in patients with incurable HNSCC that progressed with~     prior platin, 5-FU, cetuximab and taxane. Herein lies the unmet need to be addressed by this~     trial. Based on the preclinical and clinical data presented, the investigators propose that~     mitomycin C will have anti-tumor activity in these patients.~   "
91506|NCT02369445|"~     The purpose of this pilot study is to compare an innovative toilet training strategy with a~     standard behavioral intervention in children with autism spectrum disorder (ASD), as~     implemented by teachers in the school setting. Thirty classrooms with a total of 60 children~     with ASD (aged 3 - 10 years) will be enrolled in the study. Each classroom will be randomly~     assigned to either the innovative strategy group or the standard behavioral group. The~     innovative strategy employs an electronic moisture pager that sends a signal when the child~     begins having a urine accident. Outcome measures include rate of urine accidents and rate of~     toilet use in the two groups.~   "
91507|NCT02369432|"~     This proof of concept study aims to assess in patients suffering from atopic dermatitis if~     polymeric microparticles reach the pilosebaceous follicles of inflamed skin.~   "
91508|NCT02369419|"~     Background: The cardiac resynchronization therapy (CRT) has been shown to improve symptoms~     and outcome of patients with congestive heart failure (HF), and depressed left ventricular~     ejection fraction (LVEF < 35 %). The rate of non-responders to CRT is estimated at 30 %. Yet,~     the impact of frailty on the response to CRT has not been studied, until now.~      Purpose : To assess the impact of frailty in the elderly, on the response to CRT.~   "
91509|NCT02369406|"~     The overall objective of this study is to determine whether very early antiretroviral~     treatment (ART) initiation in HIV-infected infants limits the seeding of viral reservoirs and~     maintains immune responses, potentially allowing future periods off ART.~   "
91510|NCT02369393|"~     To compare the clinical and cost-effectiveness of Behavioral Activation (BA) and Physical~     Activity (PA) for adults with major depressive disorder (MDD) or adjustment disorder with~     depressive symptomatology with a wait list control group (WL) in Spanish population.~   "
91511|NCT02369380|"~     Aim of this study is to evaluate the decrease of plantar pain of forefeet due to restoration~     of plantar pad tissue density and of cushioning function with an hyaluronic acid dermal~     filler as mechanical-supplementation in subjects with metatarsalgia further use of high heel~     shoes~   "
91512|NCT02369367|"~     The goal of this clinical research study is to find the highest tolerable dose of~     lenalidomide combined with Camptosar (irinotecan) as well as to see if this drug combination~     can help control malignant gliomas.~      Researchers will also study if a special magnetic resonance imaging (MRI) technique (dynamic~     MRI scan) is useful in looking at the effect of treatment on the tumor. Another goal is to~     learn the effect of lenalidomide on tumor tissue in patients who need surgery for the~     disease.~      This record represents the Phase II portion of original Phase I/II study (see registration~     record NCT00671801).~   "
91795|NCT02365636|"~     This is a study to evaluate the safety and efficacy of 4% and 8% w/w TV 45070 ointment~     compared with placebo ointment applied topically and twice daily to the area of PHN pain for~     4 weeks in patients with PHN~   "
91513|NCT02369354|"~     Talking About Live Kidney Donation Support (TALKS) will study the effectiveness of education,~     behavior, and financial support interventions to improve consideration of live kidney~     transplantation/live kidney donation among African Americans on the deceased kidney waiting~     list. We hypothesize that interventions to help potential kidney transplant recipients and~     their potential donors overcome barriers to live donor kidney transplant (including family~     discussions, financial, or logistical barriers) could improve potential recipients' receipt~     of live kidney transplants.The main outcomes of TALKS will include whether potential~     recipients (1) have potential live donors call into the transplant center on their behalves;~     (2) have potential donors evaluated for transplant; or (3) receive a live donor kidney~     transplant.~   "
91514|NCT02369341|"~     The purpose of this study is to evaluate the safety and immunogenicity of GSK Biologicals'~     Quadrivalent Split Virion Influenza Vaccine Fluarix Tetra (2015 Southern hemisphere) in~     adults (18 to 60 years of age) and in the elderly (over 60 years of age).~   "
91515|NCT02369328|"~     Stroke is the second most frequent causes of mortality in the word after cardiovascular~     disease and the most frequent cause of disability. The majority of strokes are ischemic~     (87%). Ischemic stroke may benefit from efficient therapy if the delay from stroke onset not~     exceeds 4H30 (intra-venous thrombolysis). In case of irreversible cerebral lesion, the long~     term functional recovery is largely dependent from the ability of the brain to reorganize.~     Conventional magnetic resonance imaging represents the most sensitive tool to diagnose stroke~     at the acute phase. However, up to now, no imaging tool is available to determine the time of~     stroke onset. Moreover, no imaging tool is available to precisely quantify the functional and~     structural plasticity mechanisms occurring after stroke. The main objective of the present~     study is to test the accuracy of sodium MRI to determine the time of stroke onset. The~     secondary objectives of the study are to determine the ability of non-conventional MRI~     techniques to quantify the degree of tissue damage and brain reorganization after stroke.~     Thirty patients will be included during the first 24 hours after stroke onset. Multimodal MRI~     (including perfusion MRI, sodium MRI, resting-state functional MRI, high resolution~     anatomical MRI) and clinical evaluation will be carried on at the inclusion, after 24 hours,~     at 3 months and at 12 months.~   "
91516|NCT02369315|"~     This study evaluates Venezuela's National System of Child and Youth Orchestras, better known~     as El Sistema.~   "
91517|NCT02369302|"~     The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug~     interaction between DWC20141 and DWC20142 in healthy adult subjects.~   "
91518|NCT02369289|"~     A vegan diet is more and more prevalent in the general population in Israel in recent years.~     There have been some concerens that a vegan diet may lack in bone-health related nutrients~     (such as calcium, protein and vitamin D), and therefore may cause a decreased bone mineral~     density. The study aims to compare bome mineral density and other biochemical bone health~     parameters in vegan and omnivore non-menopausal Israely females.~   "
91519|NCT02369276|"~     The investigators suppose: 1. SND may cause damage to the soft tissue around shoulder girdle.~     2. The soft tissue injury may be related with the order of severity of wing scapula and~     duration after SND. The aims of this study are: 1. To assess the functional disabilities of~     shoulder and upper extremity in different time period after SND. 2. To evaluate the soft~     tissue lesion of shoulder with soft tissue ultrasonography to prove our hypothesis. This~     study is a two years, prospective, cross-section study. The investigators will enroll 80 HNC~     post SND within 3months, >3- 6months,> 6months -1 year, more than 1 year as four different~     groups, 20 patient in each group.~   "
91520|NCT02369263|"~     Emergency Medicine (EM) Residents routinely conduct bedside ultrasound exams in the Emergency~     Department (ED) employing the two point compression method. This study endeavors to~     investigate the accuracy and utility of bedside ultrasound for Deep Vein Thrombosis (DVT) in~     the ED by EM Residents by comparing the results of that exam against the gold standard of a~     DVT ultrasound performed in the Radiology Department and interpreted by a Radiologist.~   "
91521|NCT02369250|"~     Rosuvastatin (RSV) is a new synthetic, second-generation, sulfur-containing, hydrophilic~     statin, that stimulate bone formation in critical-size cortical bone defects adjacent to~     titanium implants, when administered locally in bone. Platelet-rich fibrin (PRF) is a~     platelet concentrate with sustained release of various growth factors, having regenerative~     potential to treat periodontal defects. Porous hydroxyapatite (HA) bone grafting material has~     clinically satisfactory response, when used to fill periodontal intrabony defects. This~     double-masked randomized study is designed to evaluate the potency of combination of RSV~     1.2mg in situ gel with 1:1 mixture of autologous PRF and HA bone graft in the surgical~     treatment of mandibular degree II furcation defects when compared with autologous PRF and HA~     bone graft placed after open flap debridement (OFD).~   "
91522|NCT02369237|"~     Anemia and inflammation are very common in patients with renal diseases. The most common~     procedure to detect anemia is to determine blood hemoglobin concentrations. The Haemospect®~     is a portable device for non-invasive hemoglobin determination that works with a sensor that~     is applicable in infants and adults alike.~      The objective of this trial is to collect spectra with the non-invasive Haemospect® device in~     children of different age groups with renal failure and different hemoglobin concentrations.~     In parallel, corresponding hemoglobin values shall be obtained invasively to form the basis~     for the development of an algorithm for the device.~      To determine inflammation, the frequencies of vasomotion and oxygenation of the tissue are~     measured non-invasively with the Haemospect®. Various blood parameters for iron and~     inflammation will also be determined, such as ferritin, hepcidin, transferrin, serum iron,~     white blood cell count and CRP.~   "
91523|NCT02369224|"~     A Cross- Sectional study; To assess the intra-rater and inter-rater reliability of a~     hand-held dynamometer (HHD) in the assessment of lower extremity strength in patients with~     multiple sclerosis~   "
91524|NCT02369211|"~     To examine pharmacoeconomics of IV acetaminophen (Ofirmev). Specifically, to examine its~     potential to improve hospital efficiency and patient outcomes. The investigators compare the~     addition of IV acetaminophen versus placebo on postoperative PACU recovery times, inpatient~     hospital length of stay (LOS), patient satisfaction scores, postoperative pain scores,~     consumption of opiates as rescue agents and side effects, and costs associated with~     postoperative medications among patients undergoing robotic-assisted laparoscopic~     prostatectomy (RALP).~   "
91530|NCT02369120|"~     Aim: The aim of this project is to identify chronic low back pain patients´ beliefs about the~     origin and meaning of pain for developing a biopsychosocial web-based educational~     intervention. The other aim of this project is to assess the effectiveness of this web-based~     educational intervention for chronic low back pain patients on pain cognitions, pain~     intensity, and disability.~      Methods: Mixed methods design, combining both qualitative and quantitative methodologies. For~     the qualitative part of this study, the investigators will use qualitative in-depth~     semi-structured interviews. For the quantitative phase we will use an experimental study~     design.~      Subjects: Chronic low back pain patients between 18-65 years old, attending a primary care~     setting in the city of Lleida.~      Expected outcomes: The investigators expect to change and modify chronic low back pain~     patients´ cognition by using our web-site educational intervention, with the further outcome~     of reducing pain and disability.~   "
91531|NCT02369107|"~     Nausea and vomiting are the most common symptoms experienced by cancer patients after~     chemotherapy. Some patients have to endure such unpleasant symptoms even after using of~     antiemetic or anti-vomiting medications.The purpose of this study is to assess the~     therapeutic effects and safety of acupuncture for chemotherapy-induced nausea and vomiting on~     patients with malignancy~   "
91532|NCT02369094|"~     Acupressure has been used for thousands of years in China. Through applying pressure on the~     specific acupoints based on TCM theory, acupressure could promote relaxation and wellness,~     balance yin-yang and treat diseases.~      The PI has been using acupressure to treat various diseases in the clinics of the School of~     Chinese Medicine, HKU. Acupressure has demonstrated significant efficacy in treating~     geriatric diseases, obstetric diseases, pediatric diseases, rheumatoid arthritis and various~     painful symptoms. When applying acupressure on the Head- Neck - Shoulder area, it could also~     help to improve insomnia, reduce pain, and regulate the mood of the patients.~      Frailty is a geriatric syndrome of growing importance in the medical field. Prevalence of~     frailty increases with age. As our life expectancy increase, there will be more elderly~     suffered from frailty in the later stage of their life. Although there is still a lack of~     universally accepted clinical definition for frailty, the syndrome is now commonly understood~     as decreased reserves in multiple systems, and lowered resilience to negative stress. Frailty~     could be initiated by single or multiple conditions including malnutrition, chronic diseases,~     lack of exercise, stress and physiological or social changes caused by aging. Its~     manifestation includes sarcopenia, anorexia, energy reduction, dysfunctional neuroendocrine~     system and a pro-inflammatory state. Frailty could affect the emotional state of the elderly,~     meanwhile, positive affect is protective against the functional and physical decline~     associated with frailty.[1] There is limited treatment or medication for frailty. The~     investigators believe that acupressure could be a possible non invasive means to improve the~     general health conditions, including the emotional conditions of the frail elderly. In the~     past 2 years, the school of Chinese Medicine has been promoting acupressure as a health~     maintenance technique to the elderly, mostly frail elderly living in the community dwelling~     through seminars. It is in our interest to run a prospective research to further understand~     the efficacy of acupressure in a wider range of frail elderly. The investigators would like~     to use a well-designed pragmatic randomized controlled trial (PRCT) to investigate if~     acupressure could help the frail elderly to improve their general quality of life.~   "
91533|NCT02369081|"~     This study was recommended by NICE, as part of its 2006 guidance for the treatment of~     hypertension, and is urgently required to provide evidence for the treatment recommendations~     in patients with resistant hypertension. The study will be a randomised placebo-controlled~     double-blind crossover comparison of an α-blocker (α), β-blocker (β), and K+-sparing diuretic~     (∆).~      Patients will have a BP at entry above target on ABPM or home monitoring despite supervised~     administration of maximum tolerated doses of A+C+D. Over 48 weeks they will then receive, in~     random order either placebo or two doses each of doxazosin (α), bisoprolol (β) or~     spironolactone (∆). Each treatment cycle will last 12 weeks, with a forced dose-doubling at 6~     weeks.~      The time course for the study will be similar to study one. 340 patients will provide 90%~     power, at α=0.01 to detect a 3 mmHg overall difference in home sBP between any one drug and~     placebo, with spironolactone hypothesized to be best overall. The study will be able to~     detect a 6 mmHg difference in sBP between each subject's best and second-best drug predicted~     by tertile of plasma renin, justifying routine use of the measurement in patients with~     resistant hypertension.~   "
91534|NCT02369068|"~     The goal of this study is to compare the effectiveness of two different medications used in~     intravaginal trigger point injections (injections into extremely painful areas of a muscle)~     to treat chronic pelvic pain. The study compares onabotulinumtoxinA (BOTOX®) (a drug prepared~     from the bacterial toxin botulin which temporarily paralyzes muscles) to Kenalog (a synthetic~     corticosteroid used as an anti-inflammatory agent).~   "
91535|NCT02369055|"~     The aim of this study is to analyze and describe rehabilitation pathways of stroke patients~     in northern Norway and Denmark in relation to how patients describe their health-related~     quality of life one year post stroke.~      The study will consist of 1) Translate, cross-cultural adapt and validate a questionnaire 2)~     Describe the level of quality of life and rehabilitation pathway in the two countries 3)~     In-depth interviews of a smaller group of patients for a more complex understanding~      The study is part of a larger prospective observational multicenter-study of two patient~     cohorts with stroke.~   "
91536|NCT02369042|"~     External measure of thoracic fluid content (TFC) combined with vital signs (HR,respiratory~     rate(RR), posture and movements) using the technology developed by Kyma Medical Technologies~     while tracking clinical changes in acute in-hospital and chronic outpatient heart failure~     patients.~   "
91537|NCT02369029|"~     This is the first study where BAY1238097 is given to humans. Impact of the study is to~     evaluate if patients with advanced cancer show clinical benefit under the treatment with~     BET(Bromodomain and extraterminal domain family ) inhibitor.Patients with solid tumors (all~     comers) and lymphoma will receive the study drug treatment in an escalation scheme (no~     placebo group) to determine the safety, tolerability and maximum tolerated dose (MTD) of~     BAY1238097. the relative bioavailability of Liquid Service Formulation and tablets will be~     determined~      After MTD is defined, patients with solid tumors (all comer, hepato cellular carcinoma, lung~     cancer, NUT(nuclear protein in testis)-midline carcinoma), melanoma and lymphoma will be~     enrolled A separate escalation scheme will be applied to patients with leucemias, and at the~     maximal tolerated dose, patients with AML amd multiple myeloma will be enrolled.~      the study will also assess the pharmacokinetics, biomarker status, pharmacodynamic parameters~     of BAY1238097 and tumor response to the treatment.~      BAY1238097 will be given twice weekly as oral application. Treatment will be stopped if the~     tumor continues to grow, if side effects occur, wich the patient cannot tolerate or if the~     patient decides to withdraw from the treatment.~   "
91538|NCT02369016|"~     To assess the safety of copanlisib~   "
91796|NCT02365623|"~     The purpose of this study is to explore safety and efficacy of TMC207 administered as part of~     a multi-drug regimen for 24 to 48-week treatment in Japanese participants with pulmonary~     multi-drug resistant tuberculosis (MDR-TB), and to evaluate pharmacokinetics (PK) of TMC207~     and its primary metabolite M2.~   "
91539|NCT02369003|"~     This pilot study is designed to follow up on a previous, preliminary study and test the~     long-term safety and feasibility of the implantation of autologous peripheral nerve grafts~     into the substantia nigra pars compacta (SNpc) or the basal nucleus of Meynert (NBM) in the~     basal forebrain of participants with PD undergoing deep brain stimulation (DBS) surgery.~     Peripheral nerve tissue contains Schwann cells which produce growth factors that have been~     demonstrated to support the survival and function of neurons.~      Participants will serve as their own donor for the tissue, which will be implanted at the~     time they undergo DBS surgery.~   "
91540|NCT02368990|"~     The aim of the study is to collect real world information on patients with locally advanced~     or metastatic non small cell lung cancer (NSCLC) who progressed after first line treatment~     with an approved Tyrosine-Kinase Inhibitor (TKI), who are known to be T790M positive and have~     been prescribed second line platinum-based chemotherapy (Pemetrexed + Cisplatin~     /Carboplatin).~   "
91541|NCT02368977|"~     This study will evaluate the feasibility of using the Third Eye Panoramic device in~     conjunction with standard colonoscopes in a clinical setting.~      Patients will undergo a colonoscopy procedure during which the study device will provide~     video imaging of areas of the colon that are difficult to evaluate with the colonoscope~     alone.~      The utility of the device will be assessed from the impressions of the investigators and from~     telephone follow-up with subjects to assess for post-procedural complications.~   "
91542|NCT02368964|"~     In standard IVF stimulation cycle,human chorionic gonadotropin (hCG) is usually used at the~     end of controlled ovarian hyperstimulation (COH) as a surrogate to only the luteinizing~     hormone (LH) surge. Yet, the last dose of follicle stimulating hormone (FSH) is usually given~     between 12-24 hours before the hCG triggering dose.One protocol used at the investigators~     unit, after a cycle with low proportion of mature oocytes per number oocytes retrieved, is~     triggering with high dose hCG (500 mcg)-38 hours prior to oocyte aspiration.~      Lately, new researches showed that dual triggering of final oocyte maturation with a~     combination of GnRH- agonist and hCG, could improve the live-birth rate of normal responders~     undergoing the GnRH-antagonist COH protocol~      Another treatment option is high dose hCG. Only few case reports have described the use of~     high dose hCG after aspiration of non mature oocytes at a previous cycle. At the~     investigators IVF unit, patients with previous history of high percentage of immature oocytes~     retrieved, are triggered at the following cycle, either with double trigger or with high dose~     of hCG decided by the physician consulting the patient. It is still not known with which way~     of triggering more mature oocytes is retrieved.~      The aim of this study is to perform a prospective randomized controlled study in patients~     with low proportion of mature-MII oocytes oocytes (<75%) per number oocytes retrieved,~     despite normal response to controlled ovarian hyperstimulation ( COH ) comparing cycles~     triggered with high dose hCG to those triggered with hCG+GnRH agonist.~   "
91543|NCT02368951|"~     To evaluate the safety, tolerability, maximum tolerated dose, pharmacokinetics, and~     pharmacodynamics of the anti-FGFR2 antibody drug conjugate BAY1187982 in subjects with~     advanced solid tumors known to express fibroblast growth factor receptor 2 (FGFR2)~   "
91544|NCT02368938|"~     The Northern Shanghai Study is a prospective community-based study, which is aimed to~     investigate the prognostic factors, including conventional cardiovascular risk factors and~     asymptomatic target organ damage, for mortality and cardiovascular diseases, in 5,000 elderly~     Chinese.~   "
91545|NCT02368925|"~     Study is a prospective clinical trial to evaluate the efficacy of the Ulthera® System to~     improve Lifting Skin on the Neck. Changes from baseline in the FACE-Q Appraisal of Neck scale~     score and Global Aesthetic Improvement Scale scores will be assessed at study follow-up~     visits.~   "
91546|NCT02368912|"~     This study consists of four parts:~      Part 1 is a randomized, double-blind, placebo-controlled, single ascending dose study in~     healthy young male subjects to evaluate the safety, tolerability pharmacokinetics (PK) and~     effect on certain hormones and if possible to determine the highest well-tolerated dose of~     ASP1707 in healthy young male subjects under fasted conditions.~      Part 2 is an open label, randomized crossover, single dose study to determine the effect of~     food on the pharmacokinetics of ASP1707and effect on certain hormones in healthy young male~     subjects.~      Part 3 is a randomized, double-blind, placebo-controlled, multiple ascending dose study to~     evaluate the safety, tolerability and pharmacokinetics (PK) of ASP1707 in healthy elderly men~     and healthy premenopausal females, and to determine the effect on certain hormones in males.~     Age and gender is also evaluated.~      Part 4 is a randomized, double-blind, placebo-controlled, parallel, multiple dose study to~     evaluate the safety, tolerability and PK of ASP1707, and its effect on certain hormones in~     healthy pre-menopausal female subjects.~   "
91547|NCT02368899|"~     This project expands upon the proof-of-concept work done under the pilot project in order to~     get Interventionaire© poised for more widespread use. Interventionaire© is designed to deploy~     a computerized interactive questionnaire to patients in a physician waiting room. The~     information gathered is intended to be a conversation starter for primary care providers and~     patients (who may feel more at ease with the computer in revealing health risk behaviors,~     like alcohol abuse). Widespread use of Interventionaire© could result in a substantial cost~     savings by delivering a wide reaching and highly acceptable prevention strategy for~     integrating risky health behavior screening and brief intervention into mainstream medical~     practice.The investigators overall hypothesis is that participants receiving the computerized~     intervention will have greater improvement than those receiving the attention control~     condition.~   "
91548|NCT02368886|"~     This randomized phase II trial studies how well lower-dose compared to standard dose~     regorafenib works in treating patients with colorectal cancer that has spread from the~     primary site (place where it started) to other places in the body and does not respond to~     treatment. Regorafenib may stop the growth of colorectal cancer by blocking the growth of new~     blood vessels necessary for tumor growth and by blocking some of the enzymes needed for cell~     growth. It is not yet known whether lower-dose or standard dose regorafenib is more effective~     in treating patients with colorectal cancer. Clobetasol propionate is a steroid cream that is~     commonly used to treat a variety of skin conditions and may help prevent hand-foot skin~     reactions in patients receiving regorafenib.~   "
91797|NCT02365610|"~     To investigate the potential antiepileptic effects of GWP42006 as add-on therapy in subjects~     with inadequately controlled focal seizures.~   "
91549|NCT02368873|"~     Study is a prospective, multicenter, randomized trial evaluating whether prophylactic~     laparoscopic placement of a dual-component IPOM mesh around a colostomy may prevent~     parastomal hernia compared with conventional colostomy after abdominoperineal resection.~     Eligible subjects will be recruited prospectively from five Finnish Hospitals (Oulu~     University Hospital,Vaasa Central Hospital, Helsinki University Hospital, Lahti Central~     Hospital, Jyväskylä Central Hospital). Patients were considered eligible for this study if~     undergoing laparoscopic abdominoperineal resection for rectal adenocarcinoma. Patients are~     randomized to prophylactic preperitoneal placement of a dual-component mesh (Dynamesh IPOM)~     around permanent colostomy or to conventional permanent colostomy. Estimating a parastomal~     hernia rate of 50%, a sample size of 26 patients per each study group is projected to provide~     90% power (1-beta) with a alpha 0.05 (2-beta) to detect a 40% reduction in risk for~     parastomal hernia at 1-year. Since we expect a dropout rate of 20%, 37 patients per study~     group will be included in this study.~      All abdominoperineal resections are performed using laparosopic technique. At the and of the~     abdominal laparoscopic phase the straight permanent end colostomy is performed. In the~     intervention group the 10 x 10 cm Dynamesh IPOM mesh is cut in the middle according to volume~     of the bowel. Stapled bowel end is then pulled through the crosswise opened mesh, which is~     pushed to the abdomen and fixed to the peritoneum.~      Follow-up visits are scheduled at 1-, 3- and 12-month after surgery. Patients are evaluated~     for their clinical status and C-reactive protein, leukocytes and hemoglobin are assessed at~     each control visit. Computed tomography (CT) scan with and without Valsalva maneuver is~     performed 12 months after surgery for radiological evaluation of possible parastomal hernia.~      The primary end-point of this study is the incidence of clinically and radiologically~     detected parastomal hernias, and their extent 12 months after surgery. The secondary outcome~     end-points were colostomy-related morbidity such as stomal stenosis, necrosis and/or wound~     infection.The extent of parastomal hernia was graded at CT according to the Hernia Society~     criteria.~      Statistical analysis is performed using a SPSS statistical software. Continuous variables are~     reported as the mean and standard deviation, whereas nominal variables are reported as counts~     and proportions. Univariate analysis is performed with the Mann-Whitney U test and Fisher's~     exact test. P-values < 0.05 are considered statistically significant.~   "
91550|NCT02368860|"~     This is an exploratory Phase I study is to assess the safety and tolerability of the OXIRI~     regimen [oxaliplatin (O), xeloda (X) and irinotecan (I)] and to evaluate for preliminary~     evidence of efficacy, in patients with advanced and/or metastatic pancreatic adenocarcinoma.~     The investigators hypothesize that 2 of 3 weekly doses of oxaliplatin and genotype~     directed-dosing of irinotecan in combination with chronomodulated capecitabine (xeloda)~     administered continuously will be more tolerable than the FOLFIRINOX regimen (folinic acid,~     fluorouracil, irinotecan and oxaliplatin) while maintaining anti-tumour activity.~   "
91551|NCT02368847|"~     Urinary tract infections are one of the most common types of infections in older persons. The~     general aim of this study is to improve the epidemiological knowledge and develop a better~     diagnostic algorithm for urinary tract infections in older institutionalized individuals in~     order to reduce excessive prescribing of antibiotics and prevent antimicrobial resistance.~   "
91552|NCT02368834|"~     This study designed and evaluated a psychoeducation program for parents of ADHD children in~     terms of improving medication adherence and clinical benefits.~   "
91553|NCT02368821|"~     A deeper understanding of the syncytiotrophoblast development processes and its properties~     may allow a better understanding of the placenta pathological process for the development of~     treatment models for the relevant pregnancy complications.The aim of this study is to compare~     telomere length, aggregate formation, and senescence markers in placentas from complicated~     pregnancy with placentas from normal pregnancy.~   "
91554|NCT02368808|"~     Coping with Loss is a randomized controlled trial to assess the effectiveness of a~     bereavement intervention targeting female adolescents who have experienced the death of~     someone important in their lives. Adolescents aged 12 and older in the Free State province of~     South Africa will be invited to participate in an 8-session school-based peer support group~     focused on coping with loss. Interventions will be implemented by Social Workers from Child~     Welfare Bloemfontein and Childline Free State (CWBFN & CLFS) that have provided support~     services for orphans and vulnerable children (OVC) in the Free State Province since 2013. The~     study population will be identified through the CWBFN & CLFS intake process and consist of~     bereaved female adolescents from up to 11 participating schools. Eligible adolescents will be~     randomly assigned to receive the intervention in 2015 or wait-listed for enrollment following~     the study period. Survey data will be collected from adolescents and caregivers before and~     two months following the completion of the interventions. Data will be analyzed to assess for~     pre- and post-test differences between the intervention and wait-listed group on key~     psychosocial outcomes, including measures of grief, resilience, mental health, social~     support, academic competence and adolescent-caregiver interactions.~   "
91555|NCT02368795|"~     Pancreatitis is the most important complication of ERCP. The severity of this condition~     varies from mild to severe and can lead to prolonged hospitalization, surgical interventions,~     and even death. Several patient-related and procedure related factors have been identified~     that are associated with a higher risk of post-ERCP pancreatitis. So far, several methods~     have been proposed to avoid pancreatitis in patients at higher risk of this complication.~      Several studies have shown that different drug therapies (indomethacin suppository, a~     sublingual nitrate tablet and the administration of intravenous Ringer's solution) each may~     reduce the incidence of post-ERCP pancreatitis. All these drug therapies are safe, cheap and~     easy to administer.~      Several other studies have shown that pancreatic duct stenting (placement of a plastic tube~     in the pancreatic duct) is an effective intervention in preventing and reducing the severity~     of post-ERCP pancreatitis, especially in high-risk groups. However, there are still a few~     drawbacks to consider with pancreatic duct stenting: there are some difficulties with~     insertion of a PD stent, it is associated with a need for radiological follow-up and/or~     repeat endoscopy for removal, higher cost and a small but important risk of complications~     (e.g. stent migration).~      Most of the clinical trials of pancreatic duct stenting were performed, before the results of~     trials of drug therapies were available. Moreover, no RCT (to the investigators knowledge)~     has compared the efficacy of pancreatic duct stenting in patients who already received a~     combination of drug therapies to prevent post-ERCP pancreatitis in high-risk patients. The~     purpose of this study is to determine the noninferiority of a combination of drug therapies~     in relation to pancreatic duct stenting to prevent post-ERCP pancreatitis in high-risk~     patients.~   "
91556|NCT02368782|"~     Otoacoustic emissions (OAEs) are non-invasive, easy to apply and objective test methods which~     are widely used to determine the presence of hearing in audiology clinics. Under some~     circumstances and children, the study should be applied under general anaesthesia. The aim of~     this study was to find out the influence of propofol (P) and ketamine (K) on OAE~     measurements. .~      Methods: Thirty- healthy children who will underwent adenoidectomy and tonsillectomy will be~     included in this study after Institutional ethics committee approval and informed consent of~     parents. Children will be evaluated one day before surgery by tympanometry. Psychologically~     prepared children will be admitted to the operating room. Following EMLA (Eutectic Mixture of~     Local Anesthetics ) cream application IV line will be inserted. ECG and non-invasive blood~     pressure will be monitored. Transient evoked otoacoustic emissions (TEOAEs) and distortion~     product otoacoustic emissions (DPOAEs) will measured in both ears of each patient (n=20 ears)~     prior to P or K administration( Pre-P and Pre-K). Propofol will be given 2mg/kg or ketamine~     2mg/kg intravenously and 40% O2 in air will be given by mask ventilation. Five minutes later~     TEOAE and DPOAE measurements will be repeated (Post-P and Post-K). After this measurement the~     routine general anaesthesia and surgical protocol will be commenced. Heart rate, blood~     pressures TEOAE and DPOAE measurements will be compared at pre and post stages by paired~     Student's t- test.~   "
91562|NCT02368704|"~     The purpose of this study is to investigate whether Endoplasmic Reticulum (ER) stress pathway~     is activated in peripheral tissues (adipose tissue) in insulin resistant diabetic patients~     compared to healthy subjects normoglycemic matched for age and sex an to investigate whether~     ER stress pathway can be activated in response to insulin. Indeed, some preliminar on rates~     studies shows that ER stress pathway is activated by insulin in liver and adipose tissue~     showing that hyperinsulinemia might help trigger stress path ER.~      For this, we propose a case control study of type 2 diabetic patients vs control subjects in~     which markers of ER stress will be evaluated from abdominal subcutaneous adipose tissue~     obtained before and after euglycemic hyperinsulinemic. We chose to consider adipose tissue~     subcutaneous rather than visceral adipose tissue for obvious reasons of lesser invasiveness.~   "
91563|NCT02368691|"~     The purpose of this study is to determine if GTx-024 is effective and safe in the treatment~     of patients with advanced, androgen receptor positive triple negative breast cancer (AR+~     TNBC).~   "
91564|NCT02368678|"~     The objective of this study was to evaluate whether short-term full mouth disinfection~     protocol could have a greater reduction in the levels of halitosis and volatile sulfur~     compound or not, when compared to quadrant-wise scaling and root planing~   "
91565|NCT02368665|"~     Compare the safety and efficacy of amlodipine besylate and candesartan cilexetil combination~     therapy on patients of essential hypertension who are not properly controlled by amlodipine~     besylate monotherapy.~   "
91566|NCT02368652|"~     Compare the safety and efficacy of amlodipine besylate and candesartan cilexetil combination~     therapy on patients of essential hypertension who are not properly controlled by candesartan~     cilexetil monotherapy.~   "
91567|NCT02368639|"~     This study will use a modified version of a positive airway pressure device to supply air to~     the participant, while undergoing supervised polysomnography. Positive airway pressures are~     typically applied to many patients with hypoventilation, in this study these pressures will~     be titrated by a qualified sleep technician. During the night these pressures will be altered~     to optimise comfort.~   "
91568|NCT02368626|"~     The need for cosmetic facial enhancement procedures with minimal down time and low risk has~     led to the development of methods for non-surgical skin rejuvenation. Various ablative lasers~     were developed, which remove the full skin surface in a controlled manner. However, the~     prolonged recovery and the significant risks prompted the development of fractional lasers~     which ablate the skin in a fractional manner, leaving untreated areas to improve healing~     process. In the past few years, fractional RF systems have been introduced that enable~     controlled skin resurfacing accompanied with dermal collagen remodeling. System using focused~     ultrasound , coagulating small volume of tissue in the dermis , have shown a lifting effect.8~     Similar to these devices the EndyMed Pro™ System with RF Micro-Needles handpiece (INTENSIF)~     enables fractional skin coagulation with dermal heating for the reduction of wrinkles~     together with a lifting effect.~   "
91569|NCT02368613|"~     The purpose of this study is to evaluate adequate-dose of DW-3102 in the treatment of~     hypercholesterolemia patients by conducting phase 2a. 4 groups involving placebo group, each~     groups are composed by 16, will be participated in this trial.~   "
91570|NCT02368600|"~     The number of women with gestational diabetes mellitus (GDM) had been increasing. Maternal~     GDM has a great impact on both the health of the mothers and the offspring. Antenatal~     lifestyle interventions, in particular dietary intervention appear to be feasible to improve~     maternal GDM and weight gain. To the best of our knowledge, there has been no such trial~     examining the feasibility of a lifestyle intervention in pregnant women in Hong Kong.~     Therefore, we plan to conduct a randomized controlled trial comparing a lifestyle~     modification program (LMP) in early pregnancy and the usual antenatal care in high risk~     Chinese pregnant women in Hong Kong. Intervention group subjects (n=110) will participate in~     a dietitian-led LMP including dietary and exercise component from the first antenatal (AN)~     booking to 24 weeks gestation. 110 women in the control group will receive routine hospital~     antenatal care. The primary endpoint will be the prevalence of GDM measured using a 75 g oral~     glucose tolerance test at 24-28 weeks gestation. The secondary endpoints will be the~     proportion of infant born with large for gestational age (>=95th percentile of the customized~     birth weight) and macrosomia (>=4 kg at birth). The intervention group involves dietary and~     exercise advice and monitoring. No drug or invasive procedure is involved. The control group~     will receive routine antenatal care and will be provided with an educational pamphlet on diet~     and exercise during pregnancy.~   "
91571|NCT02368587|"~     The purpose of this study is to investigate the safety and efficacy of intracoronary or~     intravenous infusion human umbilical Wharton's jelly-derived Mesenchymal Stem Cell (WJMSC) in~     patients with ischemic cardiomyopathy secondary to myocardial infarction.~   "
91572|NCT02368574|"~     Based on the value-based medicine, a randomized clinical trial was conducted to compare the~     role of class II and class III hysterectomy in patients with low risk early staged cervical~     cancer (defined as tumor lesions less than 2cm with less than 50% stromal invasion).~   "
91573|NCT02368561|"~     A pilot study of the effects of 3 retro-calcaneal hyalin G-F 20 injection on the clinical and~     radiological changes in 20 adult patients with changes in insertional achilles tendinopathy.~   "
91574|NCT02368548|"~     The study aims to assess the clinical and economic impact of a pharmaceutical care program~     initiated in the Emergency Department versus conventional follow-up of patients with~     decompensated heart failure/COPD.~   "
91575|NCT02368535|"~     The investigators wanted to determine if the establishment of interdisciplinary rounds has~     made meaningful changes in the perceptions of teamwork and communication.~      The purpose of this study is to determine if the establishment of interdisciplinary daily~     rounding has improved teamwork in an academic, tertiary care labor and delivery unit.~   "
91576|NCT02368522|"~     The study aims to collect information on the current treatment patterns for Hepatitis C in~     participating countries. There is also a focus on patients receiving a daclatasvir-containing~     treatment regimen who will be followed prospectively for 12 months after treatment initiation~     to collect real-world data on effectiveness and safety of the treatment. Additional analysis~     will differentiate between selected subpopulations.~   "
91798|NCT02365597|"~     The purpose of this study is to evaluate the objective response rate (complete response [CR]+~     partial response [PR]) of the selected dose regimen in participants with metastatic or~     surgically unresectable urothelial cancers that harbor specific FGFR genomic alterations.~   "
91577|NCT02368509|"~     The aim of the present study was to evaluate the impact of chemotherapy on sensorial~     perception in lung cancer patients in comparison to a control group (individuals without lung~     cancer and chemotherapy treatment). We will use a longitudinal approach whereby 44 patients~     and 44 controls will be tested for olfactory and gustatory abilities before and after~     treatment (for patients) and for two sessions separated by the same duration for controls.~     Primary measure outcome will be to examine the impact of treatment on the perception of~     hedonic valence of odors. Secondary measure outcome will include odor and taste perceptual~     changes and questionnaires on eating habits and behaviors, in order to examine the impact of~     treatment on odor, taste and food perception.~   "
91578|NCT02368496|"~     Recent progress in parenteral nutrition has contributed to improve vital prognosis and to~     reduce morbidity in patients with severe intestinal failure.~      Currently, home parenteral nutrition is the only alternative to prolonged hospitalization for~     those patients. However, long-term parenteral nutrition can result in complications~     especially in bone, such as osteopenia or osteomalacia, then increasing the risk of~     fractures. Children are especially at risk because of bone growth and peak mineralization~     acquisition during puberty.~      Moreover, frequency and risk factors of those complications are not well documented for~     children.~      Dual-energy X-ray Absorptiometry (DXA) is considered as the golden standard for bone~     mineralization measurement. In pediatrics, this technique has some limits such as the~     underestimation of Bone Mineral Density (BMD) in short stature, the overestimation of the BMD~     in tall children, and the inability to distinguish cortical from trabecular bone or to~     evaluate the bone microarchitecture.~      HR-pQCT, High Resolution peripheral Quantitative Computed Tomography enables noninvasive~     assessment of bone microarchitecture (virtual bone biopsy) using a radiation similar to DXA.~     However this technique has never been validated in patients with long-term parenteral~     nutrition.~      During the usual follow-up of the patients, HR-pQCT will be the only exam which will come in~     addition to the routine medical tests.~   "
91579|NCT02368483|"~     This is a single-group, prospective, intervention study. A total of 30 participants with~     unilateral symptomatic femoroacetabular impingement will be included into the study. The~     intervention consists in neuromuscular training for the lower limb muscles (12 weeks, 2~     times/week supervised training, 2 times/week home training). The training includes physical~     exercises routinely used worldwide in clinical settings. No control intervention group was~     included into the study because nowadays there is no standard conservative treatment for~     patients with symptomatic femoroacetabular impingement. Assessments will be performed at (1)~     baseline, (2) mid-intervention, (3) end-intervention, and (4) follow-up. Clinical,~     functional, neuromuscular and self-reported parameters will be collected during assessments.~   "
91580|NCT02368470|"~     New generations of fluoroquinolones, like levofloxacin and moxifloxacin, exhibit a~     broad-spectrum activity against Gram-positive and Gram-negative bacteria, and have been~     successfully introduced into the treatment of Helicobacter pylori infection. However, it was~     suggested that resistance to fluoroquinolones has been increasing in the Korean population~     and the resistance is most likely mediated through point mutation in gyrA. Gemifloxacin~     (FACTIVE®) is an enhanced-affinity, broad-spectrum fluoroquinolone suitable for once-daily,~     oral dosing. In vitro studies have shown that gemifloxacin displays potent activity against~     Gram-positive organisms, whilst retaining good activity against Gram-negative organisms.~     Gemifloxacin is the most potent member of the quinolone class against S. pneumoniae with~     activities 16-64 times greater than those of ciprofloxacin and ofloxacin and 2-8 times~     greater than those of moxifloxacin. Importantly, gemifloxacin displays potent in vitro~     activity against strains of S. pneumoniae with known resistance to β-lactams, macrolides and~     other members of the quinolone class. This potent activity is believed to be due to the~     enhanced affinity of gemifloxacin for topoisomerase IV, the major fluoroquinolone target in~     S. pneumoniae. Furthermore, gemifloxacin displays potent activity against H. influenzae and~     M. catarrhalis and atypical organisms such as L. pneumophila, C. pneumoniae and M.~     pneumoniae. It has proven particularly effective in respiratory and urinary tract infection.~   "
91581|NCT02368457|"~     Mandibular osteoradionecrosis, despite its low incidence, remains being the most problematic~     and irreversible complication after head and neck radiotherapy with no medical treatment to~     limit or reduce symptoms.~      Different clinical trials have shown a significant scientific evidence that the treatment~     with pentoxifylline + tocopherol achieves a certain effectiveness in the treatment of the~     tissue fibrosis. This study proposes to use this drugs to determine if there is healing of~     mandibular osteoradionecrosis and/or a symptomatic improvement as well.~   "
91582|NCT02368444|"~     The purpose of the proposed study is to evaluate the effectiveness of a cognitive behavioral~     therapy (CBT) and yoga program for improving posttraumatic stress disorder (PTSD) symptoms~     and sleep quality in people who have experienced a traumatic event and are reporting trauma~     symptoms.~   "
91583|NCT02368431|"~     This is a randomized, placebo-controlled, double-blind, 16 week trial of the medication~     zonisamide for the treatment of heavy drinking alcoholic Veterans.~   "
91584|NCT02368418|"~     China Rural Health Initiative (CRHI), a large-scale, factorial, cluster-randomized,~     controlled trial was conducted in 120 villages selected from 5 Northern Provinces of rural~     China between 2010 and 2012. Two interventions were evaluated through CRHI. One is the~     standard disease management program of individuals at high risk of cardiovascular disease~     delivered by Primary Care Providers (village doctors). Another one is a community-based Salt~     Reduction program delivered by community health educators. CRHI study interventions had ended~     for two years now and provide a good opportunity for us to understand whether its effects~     could be prolonged to a longer term. This study wants to evaluate the effects of CRHI~     interventions at 2 years after the end of CRHI (from Sep 2014 to Feb 2015).~      In this follow-up survey, the baseline cohort of 5050 and post-intervention cohort of 4887~     CRHI participants who were randomly selected from the 120 villages from 5 northern provinces~     of rural China will be recruited for the follow up study from Sep 2014 to Feb 2015. A~     questionnaire derived from CRHI baseline and post-intervention surveys will be used to~     collect data on disease history, medication use, care seeking patterns, lifestyle factors and~     so on. Weight, height, blood pressure and heart rate will be measured in the standard ways.~   "
91799|NCT02365584|"~     The primary objective of the study is to evaluate the impact on quality of life of Lanreotide~     Autogel 120 mg in combination with standard care, in comparison to the standard care alone,~     in subjects affected by inoperable malignant bowel obstruction.~   "
91585|NCT02368405|"~     This is a randomized controlled trial to study a nutrition education intervention in~     individuals with spinal cord injuries both in the acute rehabilitation setting (n = 100) and~     the community setting (n = 100). Participants in the treatment group will receive six~     interactive nutrition lectures based upon a successful program that has been used in older~     adults titled Eat Smart, Stay Well. The goals of intervention are to improve whole-grain,~     fruit and vegetable, and low-fat dairy intake and reduce fat and saturated fat intake.~     Secondary outcomes will include improvements in waist circumference of body mass index and~     some biomarkers such as cholesterol and blood sugar.~   "
91586|NCT02368392|"~     The aim of this study is to describe incidence of in-hospital deaths and outcomes after~     attempted cardiac arrest resuscitation, availability of resuscitation equipment and medical~     staff training in state Hospitals of Sri Lanka.~   "
91587|NCT02368379|"~     The purpose of this study is to determine presence of central adrenal insufficiency in~     children with Prader Willi Syndrome using low dose (1 mcg) ACTH stimulation test compared to~     results of overnight metyrapone test.~   "
91588|NCT02368366|"~     Traumatic brain injury (TBI) is the most common cause of acquired disability in youth and a~     source of significant morbidity and family burden. Novel behavior problems are among the most~     common and problematic consequences, yet many youth fail to receive needed psychological~     services due to lack of identification and access. Linking youth with TBI to effective~     treatments could improve functional outcomes, reduce family burden, and increase treatment~     satisfaction. The investigators overarching aim is to compare the effectiveness, feasibility,~     and acceptability of three formats of family problem solving therapy (F-PST) for improving~     functional outcomes of complicated mild to severe adolescent TBI: therapist-guided,~     face-to-face; therapist-guided online; and self-guided, online F-PST.~   "
91589|NCT02368353|"~     The first psychotic episodes are preceded by a pauci-symptomatic phase from 2 to 4 years~     during which the psychotic symptoms are present at a subliminal level in severity or in~     frequency. The clinical criteria mental status with risk (AR) identifies patients among~     whom 10 in 40 % will make a psychotic transition in the year.~      Our hypothesis is that interventions to reduce reactivity to stress are effective in reducing~     the intensity of psychotic symptoms in subjects with prodromal psychotic symptoms. Our~     project is to evaluate a therapy for stress management in at risk patients, compared to a~     conventional monitoring, and implement a longitudinal follow-up concerning the reduction of~     psychotic symptoms in conjunction with other markers of stress. Nonstigmatizing, these~     interventions offer an alternative to antipsychotics all the more interesting since they~     should also reduce the risk of depression and suicide.~   "
91590|NCT02368340|"~     Hermansky-Pudlak Syndrome (HPS) is a rare genetic disease that is associated with~     oculocutaneous albinism, bleeding, granulomatous colitis, and pulmonary fibrosis in some~     subtypes, including HPS-1, HPS-2, and HPS-4. Pulmonary fibrosis causes shortness of breath~     and progressive decline in lung function. In HPS patients with at-risk subtypes, almost all~     adults eventually develop fatal pulmonary fibrosis unless they undergo lung transplantation.~      The purpose of this study is to identify the earliest measurable pulmonary disease activity~     in individuals at-risk for HPS pulmonary fibrosis. The study also aims to develop biomarkers~     that will aid in understanding of the causes of HPS pulmonary fibrosis and facilitate more~     rapid conduct of therapeutic trials in HPS patients with mild pulmonary disease in the~     future.~   "
91591|NCT02368327|"~     This clinical study is part of the BIOVACSAFE project which is funded by the Innovative~     Medicine Initiative. In this study we will take a small muscle biopsy in order to identify~     any differences in the response around the actual site of injection compared with responses~     we measure in blood at the same time.~   "
91592|NCT02368314|"~     The purpose of the study is to prove equivalence of efficacy and safety of BCD-080 and Clexan~     for deep vein thrombosis and embolism prophylaxis at orthopedic surgeries.~   "
91593|NCT02368301|"~     The objective of this expanded access program is to provide treatment with elotuzumab in~     combination with lenalidomide and dexamethasone for patients with relapsed or refractory~     multiple myeloma at U.S. sites where licensed physicians determine clinical need.~   "
91594|NCT02368288|"~     The aim of interferon therapy in HBeAg positive chronic hepatitis B was to make patients~     obtain immune control to hepatitis B virus defined as occurred HBeAg seroconversion and HBsAg~     loss with sustained viral response after treatment. However this target could not be get if~     patients keep HBV DNA positive during interferon treatment and offend relapse after withdraw~     of treatment. In this trail, Nucleoside(acid) analogues(NA) will add on patients with HBV DNA~     load ≥1000copies/ml after 6 months of interferon treatment, and the efficacies of the combine~     therapy were evaluated by the rates of HBeAg seroconversion and HBsAg loss after 48 weeks of~     combined therapy, compared with control group.~   "
91595|NCT02368275|"~     The objective of these cohorts is to detect potential genetic, neurophysiological~     psychological and cognitive risk factors for the development of chronic postsurgical pain~     including neuropathic pain.~   "
91596|NCT02368262|"~     This study evaluates (risk)factors influencing (in)continence in children with and without a~     brain injury.~   "
91597|NCT02368249|"~     The investigators aim to address whether terlipressin improves the renal outcome after liver~     surgery. Therefore the investigators are planning to conduct a double-blinded randomized~     control trial. The investigators will randomize patients undergoing any kind of liver surgery~     and being at increased moderate to high risk for post-operative acute renal failure into a~     control group receiving post- operative a placebo or into a group receiving post-operatively~     terlipressin in combination with human albumin.~   "
91608|NCT02368106|"~     This study will create a patient data registry to collect and analyze information on~     technology usage and outcomes among patients receiving a broad range of relatively new~     radiation treatments that have become standards of care in our practice. Review of this~     information will serve as a basis for development of better patient management plans, to~     inform decisions about acquisition of new technologies, to provide information about quality~     in our care delivery, and to create a database that will securely warehouse ongoing~     information about what treatments the patients we serve need most and the challenges they~     face in the treatment process. The information gathered is likely to not only improve our~     services at the University of Maryland and its community sites but to advance medical science~     and enhance the quality of care for cancer patients.~   "
91598|NCT02368236|"~     This study will adapt and test a touch-screen computer program to evaluate cancer risk and~     provide patient-tailored recommendations for appropriate risk-based testing. This~     individually tailored intervention delivered right at the point of primary care and just~     prior to the office visit, can be a helpful and non-obstructive adjunct to clinical care.~      The primary aim of this project is to test whether a tailored intervention promoting~     risk-appropriate cancer testing results increases participation compared with a simple~     non-tailored reminder or no reminder. The trial is designed to determine the extent to which~     the Cancer Risk Intake System (CRIS) facilitates (1) participation in risk-appropriate~     colorectal cancer testing, as documented by electronic medical record audit; (2) patient~     receipt of risk-appropriate colorectal cancer testing recommendations from their physicians,~     as documented by electronic medical record audit; and (3) changes in patients' intent to~     participate in risk-appropriate colorectal cancer testing, as documented by patient report.~      The Family and Community Medicine and General Internal Medicine clinic databases will be used~     to identify potentially eligible patients with upcoming scheduled appointments. Because~     physicians will be the unit of random assignment, patients will be coded before study~     invitation as potential participants in the intervention or the comparison group. A random~     sample of eligible intervention and comparison group patients will be selected for contact.~     Identified patients will be mailed letters from the practices and signed by their physicians~     requesting their participation. The letters will describe a study of beliefs and practices~     about cancer prevention and early detection and will provide a toll-free number to refuse~     contact. One week after the mailing, patients who have not called to refuse contact will be~     called by study staff to explain the study, verify eligibility and, if the patient agrees, to~     arrange an in-person meeting at the clinic 30 minutes prior to their appointment. These calls~     will be made by trained research assistants who will follow standard calling protocols. After~     consent, participants will complete the computerized data collection (CRIS) immediately prior~     to a scheduled primary-care appointment. Intervention group patients and their physicians~     will receive a printout recommending risk-appropriate colorectal testing and ways to overcome~     perceived barriers to testing. A member of the research team will hand the patient his or her~     printout and will deliver the other printout to the physician. Comparison group patients and~     physicians will receive non-tailored printouts that are simple reminders about testing.~      The investigators will also establish a true no-contact control by conducting a retrospective~     chart review for randomly selected patients who did not receive an invitation to participate~     in the study. This no-contact control will establish a baseline screening rate. The~     investigators will then conduct analysis with the comparison and intervention group to see if~     individuals who participate in CRIS have a higher screening rate for colorectal cancer~     compared to the non-contact group. These additional data will help us better assess study~     Aims 1 and 2.~   "
91599|NCT02368223|"~     The aim of the study is to determine the feasibility of the portable version of the~     YouGrabber® system in children with central motor disorders.~   "
91600|NCT02368210|"~     This Phase 3 study (Study 306) has been designed to determine and compare the efficacy and~     safety of 122-0551 Foam and Vehicle Foam applied twice daily for two weeks in subjects with~     plaque psoriasis.~   "
91601|NCT02368197|"~     This study is designed to compare the safety and efficacy of paclitaxel-eluting balloon (DEB)~     versus conventional percutaneous transluminal angioplasty (PTA) for the treatment of~     hemodynamically significant recurrent cephalic arch stenosis in brachial cephalic fistulas in~     hemodialysis patients.~   "
91602|NCT02368184|"~     The purpose of this study is to obtain observational data allowing for the preliminary~     assessment of the utility of a noninvasive physiologic monitor for monitoring of patients~     with congestive heart failure.~   "
91603|NCT02368171|"~     Research design: This is a controled prospective study.~      Methodology:~      Patients with newly diagnosed and untreated OSA with total apnea-hypopnea index (AHI) >5/h,~     and control (AHI<5/h) will be recruited from the Long Beach VA sleep center. Controls are~     subjects without OSA or other sleep disorders and no sign of pulmonary hypertension based on~     echo. The investigators also measure pulmonary artery pressure by 2D Echo and exclude patient~     with any sign of left heart dysfunction. PH will be defined as RVSP > 35 mmHg or mean PA~     pressure>25 mmHg. The investigators will recruit subjects with and without PH and OSA in~     three separate groups:~        1. group one : OSA+ PH,~        2. group two: normal individual with no OSA and no PH,~        3. group three: OSA with no PH Pulmonary function test will be done to exclude patients~          with underlying lung disease.~      The inclusion criteria is: Age >20, AHI >5, AHI <5 (as control), RVSP > 35 mmHg OR Mean PA~     pressure>25 mmHg, RVSP < 35 mmHg OR Mean PA pressure < 25 mmHg (as control).~      Subjects will be excluded if they had known peripheral vascular disease, liver disease,~     hemolytic anemia, inflammatory disease, active infection, or if they were pregnant, on~     therapy for OSA, on chronic steroid treatment, or younger than 20 years of age, patients with~     left heart failure (systolic or diastolic), patients are on PH medications including~     sildenafil, active smokers, COPD and asthma, active infection or inflammatory disease and~     collagen vascular disease.~      Nocturnal polysomnography will be performed and scored according to the American Academy of~     Sleep Medicine.~      Exhaled Carbon monoxide (CO) will be measured with a calibrated fuel cell type~     electrochemical device with sensor sensitivity of 1 ppm. The mean of three reproducible~     measurements will be recorded and corrected for ambient CO.~      Exhaled Nitric Oxide (NO) will be measured. At each testing session, at least three~     flow-regulated FENO measurements will be performed.~      The investigators will repeat 2D Echo and measurements of above factors after 3 months of~     CPAP treatment. The investigators also check patient's compliance with the treatment by~     downloading data off of their CPAP device.~      Each subject will be informed of the experimental procedures, which is approved by the Human~     Investigation Committee of the VA-Long Beach.~      Finding:~      The investigators hypothesize that HO pathway causing perturbation of pulmonary endothelial~     function by inhibition of nitric oxide.~      Clinical significance:~      OSA is associated with PH, but exact mechanism is not well known. In the past, I have shown~     that increased endogenous CO in the setting of elevated NO concentration is associated with~     endothelial dysfunction in patient with OSA. Therefore, the investigators sought to~     investigate the roles of HO and NO pathways in patients with OSA associated with PH.~      Impact/significance:~      It addresses a fundamental gap in our understanding of how OSA results in increase the~     pulmonary artery pressure and if substantiated, will provide the basis for the design and~     testing of new approaches to prevention and treatment of OSA.~   "
91604|NCT02368158|"~     In this study predictors of fitness to drive a car in cardiologic patients after acute~     intervention and discharge from hospital to home or rehabilitation are determined in addition~     to possible automotive monitoring of vital signs via contact less sensors.~   "
91605|NCT02368145|"~     This study is being done to see if there is a relationship between stroke, post-stroke~     depression, and measures of inflammatory and/or stress compounds in the blood. Brain injury,~     as caused by stroke, leads to an inflammatory response in the brain which in turn can~     influence inflammatory and stress responses in other parts of the body outside of the brain.~     These responses can be measured by analyzing various substances in the blood and in the white~     blood cells. The investigators will measure these substances (cytokines, glucocorticoids) and~     compare them to the absence, presence, or degree of depression that the investigators will~     determine by neurological and psychological testing. The investigators will be drawing blood~     for this study on admission, at or around day 3, at or around day 7 and at or around day 90,~     which is not part of routine stroke care. The investigators will be asking subjects to~     participate in answering question/scales on these same days, some of these questionnaires are~     also not part of routine stroke care. Standard stroke care is being done other than blood~     drawing/participating in answering questions/scales. Approximately 25 people will be enrolled~     over one year.~   "
91606|NCT02368132|"~     The proposed study seeks to compare usual care and two different interventions for caregivers~     (CGs) of Veterans with dementia that are brief and administered by telephone. In the first~     intervention, care management (i.e., assistance from a nurse or social worker who works with~     the CG and Veteran's primary care providers), support, psychoeducation, and skills training~     are tailored to each individual CG and delivered on an individual basis. In the second~     intervention, care management is tailored and delivered to each individual CG, but support,~     psychoeducation, and skills training are delivered (also by phone) in a group format. This~     study will allow us to examine the added benefit of participating in a CG group that provides~     mutual peer support and feedback. The investigators also will evaluate the extent to which~     spousal vs. adult child CGs respond differently to the two interventions. Findings will help~     refine patient/CG-centered care management and support programs designed to facilitate access~     to services and improve the quality of life of Veterans with dementia and their families.~   "
91607|NCT02368119|"~     Ebola virus causes an infection known as Ebola virus disease (EVD). This it is generally a~     severe disease which can also lead to death. The 2014 outbreak of EVD in West Africa is the~     largest ever. Researchers want to develop a vaccine to prevent Ebola infection.~      This study will assess the safety of a single dose of the bivalent Ebola Zaire candidate~     vaccine VRC-EBOADC069-00-VP (cAD3-EBO) when administered to healthy Malian adult volunteers,~     age 18-65 years (mostly health care workers and other front line workers [e.g., individuals~     who incinerate contaminated materials]), at one of 2 dosage levels, 2.0 x 10(10) vp or 2 x~     10(11) vp. It is impossible for someone to get an Ebola infection from this vaccine.~      Heterologous booster dose allocation - Each participant will be offered the opportunity to be~     included in the booster step of this study. After obtaining consent and the additional review~     of pertinent medical history, participants in each group will be randomized to receive the~     candidate booster vaccine, MVA-EbolaZ or placebo.~      This will be the first clinical trial in Mali with bivalent cAd3-based Ebola vaccine and the~     first where the dosage level contains > 10(11) vp. It follows completion of a Phase Ib trial~     in Malian health care workers that tested three dosage levels of monovalent cAd3-EBO Z~     vaccine. The data generated in West Africans (Mali) on the tolerability and immunogenicity of~     the bivalent vaccine will be compared to clinical and immunologic responses documented in in~     parallel studies in East African subjects (Uganda) and North American subjects (NIH,~     Bethesda, MD, USA).~      Objectives:~        -  To see if an Ebola vaccine is safe and to study immune responses to it.~        -  To study the effect of the MVA-EbolaZ booster on the immune response~      Eligibility:~      - Healthy adults ages 18-65.~   "
91612|NCT02368054|"~     Cervical conization is done for pre-cancer disease. The procedure is performed with local~     anesthesia and general anesthesia. Local anesthesia is given by paracervical block, and~     several different local anesthetics is being used including bupivacaine with and without~     adrenaline. Adrenaline might reduce local bleeding and reduce toxicity of bupivacaine by~     reducing absorption, but might affect cardiovascular function. This study will examine this~     effect.~   "
91613|NCT02368041|"~     This is a single-center, non-randomized study.The study staff will use the InSpectraTM tissue~     oxygen saturation (StO2) monitor manufactured by Hutchinson Technology to measure baseline~     StO2 levels after applying the noninvasive probe to the thenar eminence. After a stable~     reading is obtained, a blood pressure cuff will be inflated 40 mmHg above the obtained~     systolic pressure and the rate of desaturation (Rdes; % × sec-1) will be recorded. After 3~     minutes or once the StO2 level comes to zero (whichever is earlier), the cuff pressure will~     be released and the rate of reperfusion (Rres; % × sec-1) will be measured. The investigators~     hypothesize that heart failure in children causes a baseline lower thenar tissue oxygen~     saturation (StO2), a faster rate of desaturation (Rdes) and a prolonged rate of reperfusion~     (Rres). The investigators also hypothesize that these changes will correlate with the~     severity of heart failure. The results of this study will provide groundwork for studies~     looking at correlation of therapy modification based on the combination thenar StO2 and~     clinical presentation.~   "
91614|NCT02368028|"~     The fact that dental caries remains a major public health problem mandates that oral-health~     researchers explore new strategies for assessment of caries risk, as well as for caries~     prevention and management. Dental caries occurs when acids produced by bacterial glycolysis~     of dietary carbohydrates causes demineralization of the tooth enamel. A major focus of caries~     research has been on identifying and characterizing acid-generating bacteria and the~     mechanisms of acid resistance. The purpose of this study is to investigate the type of~     bacteria that grows in the mouth and on teeth.~   "
91615|NCT02368015|"~     Hepatic cysts are fluid-filled cavities located in the liver parenchyma. They are usually~     asymptomatic, but can cause mass-related symptoms as abdominal pain, dyspnea and nausea.~     Aspiration sclerotherapy is indicated in patients with a dominant hepatic cyst to alleviate~     symptoms by draining the hepatic cyst to reduce cyst diameter. Spontaneous cyst infection, or~     following aspiration sclerotherapy, presents a severe complication of hepatic cystic disease~     requiring frequent hospitalization, long-term antibiotic treatment, and in some invasive~     therapies. Evidence that antibiotics are able to reach adequate intracystic concentration is~     however lacking. To prevent procedure-related cyst infection in patients receiving aspiration~     sclerotherapy, cefazolin prophylaxis is given as standard of care. In this study we want to~     assess the hepatic cyst penetration capacity of cefazolin by comparing serum and cyst fluid~     concentrations of cefazolin. We hypothesize that cefazolin is able to penetrate hepatic~     cysts, with treatment naïve cyst allowing a better penetration, reducing the risk of~     developing cyst infection following aspiration sclerotherapy.~   "
91616|NCT02368002|"~     The purpose of this study is to learn how to personalize weight loss programs. In this~     research we will study:~        1. Whether a weight loss counselor should decide if the traditional weight loss therapy is~          working either after 3 or 7 weekly sessions of therapy and~        2. For those who haven't lost the expected amount of weight, whether it is more effective~          to add packaged meals to the traditional weight loss therapy or to change to an enhanced~          version of behavioral weight loss therapy.~   "
91617|NCT02367989|"~     Lifestyle modifications that include a diet high in fibre may lower the risk of developing~     type 2 diabetes (CDA, 2013). In this context, the presence of soluble dietary fibre in~     carbohydrate rich foods has been widely recognized for its effect on post-prandial glucose~     response (PPGR). Among these, oat and barley derived β-glucan have received tremendous~     attention for their biological effects, including their ability to reduce PPGR in a wide~     variety of food matrices (Poppitt et al, 2007). A health claim for PPGR would increase market~     demand for food grade barley, and help those who want to limit the rise in blood sugar after~     a meal choose products to meet their goals, but there are several gaps in the literature that~     need to be filled before a submission to Health Canada can be successful: 1) test foods in~     appropriate serving sizes; 2) test both the glucose and insulin response; 3) include a~     reference product that matches in total fibre, macronutrient, and energy profile; 4) perform~     dose response. The proposed study design will address all of these gaps in the current~     literature and take into consideration Health Canada's guidance document for health claims~     related to the reduction in PPGR, which sets out the criteria by which the validity of such~     claims will be assessed.~      Hypothesis:~      Barley β-glucan will reduce the PPGR in healthy participants in a dose dependent manner.~      Specific objectives:~        1. To determine the minimum and most effective dose of barley β-glucan in waffles on PPGR~          and insulin response in a cross-over, randomized, controlled clinical trial.~        2. To assess the effect of barley β-glucan in waffles on appetite-related sensations using~          visual analog scales.~        3. To demonstrate whether the test and reference products were liked or disliked similarly~          by participants.~        4. To assess any gastrointestinal side effects from eating the test products~   "
91618|NCT02367976|"~     The purpose of the study is to evaluate the efficacy and safety of rh-prouk as~     pharmacoinvasive therapy on those ST Elevated Myocardial Infarctions patients, it is designed~     as a multicenter, active controlled, single blinded study. The primary endpoint is to assess~     the coronary recanalization 90 minutes after thrombolysis. The secondary endpoint is to~     evaluate the mortality rate at day 30.~   "
91635|NCT02367755|"~     Therapeutic hypothermia has been proven to significantly improve the survival and~     neurological prognoses in patients resuscitated from cardiac arrest. Propofol has been~     reported to exhibit potentials in mitigating ischemia-reperfusion injury via the~     antioxidative, anti-inflammatory and neuroprotective mechanisms. This study is to investigate~     the potentials of propofol in further improving the survival and neurological prognoses in~     this era of therapeutic hypothermia.~   "
91636|NCT02367742|"~     It has been demonstrated the essential role of physical activity in the prevention of~     overweight and obesity. Nevertheless, the effect of a program of physical activity on the~     maintenance of body weight in subjects who have previously followed a dietary intervention is~     still unknown. The aim of this study was to investigate this topic by evaluating the effect~     of two different programs of physical activity on subjects who have followed a dietary~     intervention but presented again NAFLD a year after the treatment.~   "
91637|NCT02367729|"~     This study evaluates the effectiveness of a neurostimulator applied to the outer ear for~     adolescents with functional gastrointestinal disorders. The neurostimulator provides nerve~     stimulation to a branch of the vagus nerve which is thought to be involved in transmission of~     pain signals. Half of the study subjects will receive an active nerve stimulator while the~     other half will receive an inactive one.~   "
91619|NCT02367963|"~     Cardiovascular disease is the leading cause of death in Spain and worldwide. Interventions~     targeting dietary patterns, weight reduction and new physical activity habits often result in~     impressive rates of initial behavior changes, but frequently these are not translated into~     long term maintenance. We hypothesize that a peer-group intervention, addressing multiple~     facets of cardiovascular disease risk factor can be successfully implemented improving the~     adherence of participants to healthy habits.~      A multicenter, randomized control trial scheme was adopted. A peer-group based intervention~     approach in which community members support each other to promote health-enhancing changes~     was chosen. Around 600 participants from 7 Spanish municipalities received a 12h initial~     training and were randomly allocated to intervention or control groups for a 12-month peer~     intervention. Baseline measurements took place before and after the initial training.~     Follow-up measurements will be taken at the end of the intervention and 1 and 2 years after~     the end of the study. The primary outcome is the improvement in a newly defined score~     combining 5 individual variables. Secondary outcomes are 1, 2 and 3 years variations in~     anthropometric parameters and/or healthy behaviors.~      The project seeks the empowerment of subjects from 25 to 50 years of age to improve their~     overall health habits and self-control of risk factor through peer education. The initiative~     is being developed in cooperation with the Spanish Agency for Consumer Affairs, Food Safety~     and Nutrition (AECOSAN). This study will allow the economic and feasibility evaluation of the~     intervention, which will enable policy makers to consider its potential wider implementation~     for a real community-based intervention.~   "
91620|NCT02367950|"~     The purpose of the study is to evaluate the feasibility of introducing an exercise programme~     for endometrial cancer survivors.~   "
91621|NCT02367937|"~     The aim of the study is to evaluate the effect of PRC-4016 at steady state on the~     pharmacokinetics (PK) of cytochrome P450 (CYP) 3A substrates (midazolam, simvastatin), a~     CYP2C9 substrate (omeprazole) and a CYP2C19 substrate (flurbiprofen) in healthy male/female~     subjects.~   "
91622|NCT02367924|"~     Efficacy and safety of trabectedin in real-life practice, routinely used for the management~     of advanced sarcoma after failure of anthracyclines and ifosfamide or patients unsuited to~     receive these drugs in Germany.~      Trabectedin is indicated for the treatment of patients with advanced soft tissue sarcoma,~     after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents.~     Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients.~   "
91623|NCT02367911|"~     This Phase 3 study has been designed to determine and compare the efficacy and safety of~     122-0551 Foam and Vehicle Foam applied twice daily for two weeks in subjects with plaque~     psoriasis.~   "
91624|NCT02367898|"~     The purpose of this study is to measure the efficacy of an online cognitive training program~     against an active control condition in a large, randomized trial.~   "
91625|NCT02367885|"~     The purpose of this study is to evaluate the safety and immunogenicity of an intramuscular~     injection of TAK-850 in healthy pediatric Japanese participants.~   "
91626|NCT02367872|"~     The purpose of this study is to examine the effects of renal and hepatic impairment on~     TAK-272 pharmacokinetics with a single oral administration of TAK-272 in participants with~     renal or hepatic impairment.~   "
91627|NCT02367859|"~     This pilot clinical trial studies dabrafenib and trametinib in treating patients with~     ameloblastoma and a specific mutation (change) in the BRAF gene. Dabrafenib and trametinib~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
91628|NCT02367846|"~     This preclinical randomized crossover study will examine the effects of oral versus non-oral~     contraceptive therapy on bone turnover in young exercising women. In an effort to expose the~     route-dependent effects of oral versus non-oral contraceptive therapy on bone turnover, the~     investigators will examine 1) the effects of ethinyl estradiol on bone calcium balance using~     the 41Ca technology and 2) the underlying physiological mechanisms associated with the~     effects of oral versus non-oral contraceptive therapy on net bone calcium balance.~   "
91629|NCT02367833|"~     This study will determine whether the negative effects of combined oral contraceptive (COC)~     therapy on the growth hormone/insulin-like growth factor-1 (GH/IGF-1) axis and bone turnover~     are dependent on the route of administration such that an attenuation of these effects is~     observed when a comparable dose of non-oral transdermal contraceptive (TDC) and contraceptive~     vaginal ring therapy (CVR) are also tested.~   "
91630|NCT02367820|"~     The purpose of this 52-week open label study is to determine the safety of a new opioid~     molecule, NKTR-181, in patients with moderate to severe chronic low back pain or chronic~     non-cancer pain.~   "
91631|NCT02367807|"~     This is a 48-week prospective observational study that will allow testing of the hypothesis~     that a program in which pre-exposure prophylaxis (PrEP) is administered to young men of color~     who have sex with men (yMSMc) in a community youth drop-in center in conjunction with a~     multifaceted behavioral intervention as well as standard HIV prevention interventions can~     achieve at least 70% retention, as well as a medication adherence rate significantly better~     than that previously reported in the literature. The proposed program evaluation can provide~     critical information for the enhancement and scale-up of successful PrEP programs at FIGHT~     and elsewhere in an effort to make PrEP available to a growing number of persons at risk of~     acquiring human immunodeficiency virus (HIV).~   "
91632|NCT02367794|"~     This randomized, open-label study will evaluate the safety and efficacy of atezolizumab~     (MPDL3280A) in combination with carboplatin + paclitaxel or carboplatin + nab-paclitaxel~     compared with treatment with carboplatin + nab-paclitaxel in chemotherapy-naive participants~     with Stage IV squamous NSCLC.~   "
91633|NCT02367781|"~     This randomized Phase III, multicenter, open-label study is designed to evaluate the safety~     and efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 [PD-L1] antibody)~     in combination with carboplatin+nab-paclitaxel compared with treatment with~     carboplatin+nab-paclitaxel in chemotherapy-naive participants with Stage IV non-squamous~     NSCLC. Participants will be randomized in a 2:1 ratio to Arm A~     (Atezolizumab+Nab-Paclitaxel+Carboplatin) or Arm B (Nab-Paclitaxel+Carboplatin).~   "
91634|NCT02367768|"~     The investigators were looking for resuscitation management, trauma mechanism, risk factors,~     and de novo biomarkers related to prognosis and long-term outcome for evaluating trauma~     patients besides injury severity score (ISS) guiding the traumatologist. The medicare~     resource could be utilized efficiently along with increasing in the survival and quality of~     lifer (QoL) in major trauma.~   "
91638|NCT02367716|"~     The purpose of this clinical study is to observe the safety and efficacy of the multi-vector~     LV lead in Chinese patients that are indicated for Cardiac Resynchronization Therapy (CRT).~      This is a multi-center, non-randomized observational study.~      The total duration of the study is expected to be 2.5 years. The clinical study will be~     conducted in no more than 15 centers in China. Approximately 120 subjects will be enrolled in~     this study. Subjects will be followed up at 3, 6, 12months and every 6 months afterwards. All~     subjects need to be followed for at least 6 months.~   "
91639|NCT02367703|"~     Hysterectomy for benign uterine disease is often intended to young perimenopausal patients.~     Currently laparoscopic hysterectomy is commonly used in this indication. We are wondering if~     decreasing the diameter of laparoscopic instruments could reduce postoperative pain and~     improve esthetic result without increasing operative time. The purpose of the study is to~     improve patients' care.~   "
91640|NCT02367690|"~     Patients with eligible diabetic foot ulcers will be screened, treated, and followed for~     complete ulcer closure. This is a randomized trial. All patients will receive~     standard-of-care treatment. Additionally, some patients will receive treatment with topical~     Selinexor gel and some will receive topical placebo gel.~   "
91641|NCT02367677|"~     To compare measurements made by a computer software (ImageJ) made on photographs to the~     traditional clinical measures with a ruler in the evaluation of blepharoptosis~   "
91642|NCT02367664|"~     Japanese encephalitis (JE) is an acute viral zoonotic disease. Neurologic manifestations of~     the disease range from subtle changes in behavior to serious problems, including blindness,~     ataxia, weakness, and movement disorders. The Japanese encephalitis virus (JEV) occurs~     primarily in Southeast Asian. It is spread by culicine mosquitoes, most often Culex~     tritaeniorhynchus. Its incubation period is 5 to 15 days.In China, JE epidemic peak season is~     from June to August and it mainly occurred in children. JE has ranked in top ten infectious~     diseases according to either incidence or mortality. JE vaccines are used to protect the~     population especially young children and infants from encephalitis diseases. Live attenuated~     JE vaccines are now widely used. They are directly produced from attenuated virus which may~     increase the possibility of virulence reversion. Many developed countries are using purified~     model inactivated JE vaccine. Therefore, it is an inevitable trend in China to develop a new~     generation of safer and more effective inactivated vaccine to prevent and control epidemic~     encephalitis.~   "
91643|NCT02367651|"~     Pazopanib monotherapy is approved by the Food and Drug Administration (FDA), European~     Medicines Agency, and other regulatory authorities worldwide for the treatment of patients~     with advanced renal cell carcinoma and patients with advanced soft tissue sarcoma (STS) who~     received prior chemotherapy. Based on the improved progression-free survival and sustained~     responses observed in a pivotal Phase 3, randomized, placebo-controlled study, it is~     hypothesized that pazopanib may have a role in a maintenance setting for STS in maintaining~     the initial response to chemotherapy and delaying the need for further treatment at relapse~     and its associated toxicity and impact on health-related quality-of-life. This Phase 2,~     randomized, double-blind, placebo-controlled study will evaluate maintenance therapy with~     pazopanib versus placebo in subjects with advanced or metastatic STS who have not progressed~     after 4 to 6 cycles of first-line anthracycline-based chemotherapy. Approximately 188~     eligible subjects will be randomized in a 1:1 ratio to treatment with pazopanib 800~     milligrams (mg) daily or placebo. Study completion will be the point at which 70% of~     randomized subjects have died. Once a subject has objective evidence of disease progression,~     the subject will be managed as per standard practice by their physician. Subjects will~     continue to be followed for second progression, health related quality of life, survival~     until study completion, withdrawal of consent, or early termination of the study.~   "
91644|NCT02367638|"~     The purpose of this study is to determine whether varicella live vaccine is safe and~     effective in the healthy adults.~   "
91645|NCT02367625|"~     Globally, cervical cancer is the second most common cancer for women and kills approximately~     250,000 women every year, with the annual number of deaths expected to increase to 410,000 by~     2030. The majority (88%) of these deaths occur in low- and middle-income countries (LMICs)~     where screening and prevention services are limited. Prevention of cervical cancer by~     identification and treatment of cervical cancer precursors is key, since treatment resources~     for invasive disease are scarce. A cervical cancer screening program cannot be effective~     unless it is linked with a proven intervention to prevent the development of cervical cancer.~     The World Health Organization (WHO) recently released the WHO guidelines for screening and~     treatment of precancerous lesions for cervical cancer prevention, which recommends a~     screen-and-treat approach for cervical cancer prevention, with cryotherapy being the first~     choice of treatment for women who have a positive screen. However, these programs are still~     slow to be implemented in part due to the current high cost and low efficiency of cryotherapy~     equipment that is often prone to breaking. Jhpiego, an affiliate of Johns Hopkins University,~     has developed a new cryotherapy device, CryoPop, that is one tenth the cost of current~     equipment while also ten times more efficient. Once proven safe, feasible and effective,~     CryoPop could save tens of thousands of lives in low- and middle-income countries each year~     by preventing cervical cancer.~   "
91655|NCT02367482|"~     In this research study, we will track the build-up of tryptophan, a radioactive tracer, in~     the brain using positron emission tomography (PET) scanning. Tryptophan, in its natural~     state, is an amino acid (one of the building blocks of proteins) that is normally present in~     the brain, and is used by the brain cells to create various other compounds. This process is~     altered in the presence of a brain tumor. By using a form of tryptophan marked with a small~     amount of radiation, we will be able to track this process during the course of the PET scan.~     This research will help determine if AMT PET is a useful method to recognize and~     differentiate between various types of brain tumors. In addition, to study the mechanisms of~     altered tryptophan uptake in the tumor and brain, we will also measure tryptophan levels and~     related molecules in your blood (obtained as a part of the PET procedure) and tumor tissue~     (in case you will have surgery to remove the tumor). This will help us to find new approaches~     to treat brain tumors in the future by altering abnormal tryptophan metabolism.~   "
91927|NCT02363894|"~     The purpose of this DEFINITIVE AR Two Year Follow-up Extension Study is to gather data to~     assess and estimate the long term effect of treating a vessel with plaque excision (PE) in~     combination with paclitaxel-coated balloon angioplasty (PTX PTA) compared to treatment with~     PTX PTA alone.~   "
91646|NCT02367612|"~     Respiratory and gastrointestinal infections are common in children under the age of 4 years,~     especially after the start of schooling. These conditions are facilitated by a still~     incomplete functional maturation of the immune system and the anatomical structure and~     function of the respiratory and gastrointestinal tract still developing. The frequency and~     duration of these conditions involves a high discomfort and significant costs, in relation to~     medical appointments, taking medication, the need for hospitalization, days of absence from~     school and work days lost by parents. Functional foods derived from the fermentation of cow's~     milk with probiotic strains have been proposed for the prevention of infectious diseases in~     children. Several products have been investigated, with sometimes conflicting results.~     Diversity in experimental designs, populations evaluated, and bacterial strains used in the~     preparation of fermented products are probably responsible for these discrepancies. Recently~     we started a study approved by the Ethics Committee for Biomedical Activities Carlo Romano~     of the University of Naples Federico II (protocol number 210/12) to evaluate the~     effectiveness of foods fermented with Lactobacillus paracasei CBA-L74 in the prevention of~     common winter infections in school children aged between 12 and 48 months. Studies of~     pre-clinical phase showed anti-inflammatory activity of milk fermented with the strain~     Lactobacillus paracasei L74-CBA in terms of stimulation of the production of the cytokine~     IL-10 and decreased synthesis of IL-12, also in response to stimulation with Salmonella~     typhimurium. The data were obtained in in vitro studies on dendritic cells and ex vivo~     intestinal biopsies as well as in tests on healthy mice and on a mouse model of experimental~     colitis. A preliminary analysis of the data was found that subjects treated with fermented~     milk showed fewer infectious episodes, as well as a lower incidence of respiratory tract~     infections or gastrointestinal, with a statistically significant difference between the study~     groups. It was also observed a significant increase in the levels of α- and β- defensins,~     LL-37 and secretory IgA in the group of subjects treated with fermented milk compared to~     subjects treated with fermented rice or placebo.~      Therefore, we decided to extend the period of study of five additional months, in order to~     perform an evaluation of the effectiveness of fermented milk (which was more effective)vs~     placebo.~   "
91647|NCT02367599|"~     CCTG 595 is an open-label clinical trial of the effect of a text messaging intervention vs.~     standard of care on adherence to Truvada as PrEP in MSM at increased risk for HIV infection~     (ClinicalTrials.gov Identifier: NCT01761643). Eligible subjects for this matched case control~     substudy will receive vitamin D 4000 IU/day for 24 weeks, from week 24 through week 48. In~     CCTG 595, plasma from participants are being collected and stored at entry and every 12~     weeks. These plasma samples will be used to measure P1NP, CTX, PTH, and vitamin D levels in~     both cases and controls at entry, week 24, and week 48.~   "
91648|NCT02367573|"~     Inguinal hernia can be repaired laparoscopically. In the normal laparoscopy there are only~     two-dimensional view, which is somewhat challenging when operating in three-dimensional~     environment. The three-dimensional laparoscopic systems are gradually entering the operating~     rooms. There are plenty of evidence of the benefits of 3D-system in laboratory conditions.~     However, no prospective randomized trials have been published in the clinical point of view.~     Therefore, the purpose of this study is to investigate is there something to gain in changing~     into 3D laparoscopic system in the transabdominal pre-peritoneal (TAPP) inguinal hernia~     repair.~   "
91649|NCT02367560|"~     Calcific tendinitis is a common and challenging problem in the orthopedic surgeon's office.~     The chronic and variable course of the condition can lead to dissatisfaction with~     conservative management. Current standard of care at the Thunder Bay Regional Health Sciences~     Centre is referral for treatment by either needle decompression therapy by a radiologist or~     shockwave therapy by a physiotherapist. The purpose of this study is to compare the~     efficacies of these treatment options.~   "
91650|NCT02367547|"~     This pilot study compares three photosensitisers, hexylaminolevulinate (HAL) and~     aminolevulinic acid nano emulsion (BF-200 ALA) to methylaminolevulinate (MAL) in photodynamic~     therapy of superficially growing basal cell carcinomas. Study is conducted using randomised~     prospective double blinded comparing design. Fluorescence is measured in A.U. (Arbitrary~     Unit) with standardised set-up before and after the exposure. Efficacy is assessed~     clinically, histologically and by hyperspectral imaging system at 3 months, 12 months and 5~     years.~   "
91651|NCT02367534|"~     Islet transplantation is one of the effective and promising options for type 1 diabetes~     mellitus treatment1-4. The liver is the primary target location for infusion and portal vein~     catheterization is generally used. Percutaneous transjugular, percutaneous transhepatic,~     laparoscopically transmesenteric and laparoscopically transumbilical approaches were often~     utilized to access the portal. Current islet infusion approach via portal vein of liver has~     various defects. Percutaneous trans-hepatic puncture is risk of possible severe hemorrhage~     and portal thrombosis. The laparoscopic entry techniques require longer surgical duration and~     have an increased rate of catheterization failure. Moreover, the catheters were not allowed~     to indwell for subsequent infusions.~      In the current study, the investigators aim to performed open surgery, catheterized the~     umbilical vein and infused islets into the portal vein. The catheter was indwelled for one~     month after surgery. Therapeutic effects, surgical parameters and complications were observed~     to evaluate feasibility and safety.~   "
91652|NCT02367521|"~     Traumatic brain injury (TBI) is frequently complicated by depression and other problems such~     as post traumatic stress disorder (PTSD), sleep disturbance, cognitive deficits and~     behavioral problems. Untreated depression can lead to reduced productivity and poor global~     outcome. There is no Food and Drug Administration (FDA) approved drug for the treatment of~     TBI-related depression. The overarching goal of this small study is to determine the~     effectiveness of low frequency right (LFR) rTMS for the treatment of post-TBI depression and~     co-occurring psychiatric symptoms. Repetitive transcranial magnetic stimulation (rTMS) is a~     brain stimulation technique. It involves generating a brief magnetic field in a coil that is~     placed on the scalp. The magnetic field passes through the skull and induces a weak~     electrical current in the brain that briefly activates neural circuits at the stimulation~     site. Adults aged 18 and older, with a history of head injury of mild or moderate severity ,~     who are currently experiencing symptoms of clinical depression may join the study.~   "
91653|NCT02367508|"~     The study evaluates the feasibility, acceptability, and preliminary efficacy of a mindfulness~     meditation-based intervention designed to provide a synergistic solution to the avoidant~     coping that often inhibits advance care planning discussions that are crucial to quality~     end-of-life care.~   "
91654|NCT02367495|"~     Hypothesis:~      Angioplasty with a novel paclitaxel-coated balloon (PCB; Agent, Boston Scientific) with~     citrate-based excipient will be non-inferior to conventional paclitaxel-coated balloon with~     iopromide excipient (PCB) for the treatment of coronary restenosis after implantation of~     limus-analogue drug-eluting stents (DES)~   "
91656|NCT02367469|"~     The main purpose of this study is to determine the potential clinical utility of PET imaging~     using the radiotracer [C-11]alpha-methyl-L-tryptophan in the diagnosis, differentiation and~     monitoring of various brain tumors, both before and after initial treatment. We will also~     study mechanisms and clinical significance of abnormal brain tumor tryptophan metabolism~     using resected tumor tissues.~   "
91657|NCT02367456|"~     This multi center open label Phase 1b study is designed to evaluate the safety, efficacy,~     pharmacokinetics (PK), and pharmacodynamics (PD) of glasdegib (PF-04449913) when combined~     with azacitidine in patients with previously untreated Higher Risk Myelodysplastic Syndrome~     (MDS), Acute Myeloid Leukemia (AML), or Chronic Myelomonocytic Leukemia (CMML). This clinical~     study includes two components: (a) a safety lead in cohort (LIC) and (b) an expansion phase~     with an AML cohort and an MDS cohort.~   "
91658|NCT02367443|"~     This is a phase I/II trial on concomitant RT-full dose CHT using accelerated~     hypofractionation schedule as currently being in routine use in Poland for sequential~     combination or RT alone. Objectives of the study are: to estimate rate of grade ≥ 3 CTCAE~     adverse effects related to treatment and to estimate tumor control, progression~     free-survival, and overall survival in patients treated with this regimen. Stage III NSCLC~     patients are treated according to the following schedule: RT: 58.8 Gy in 21 fractions (2.8~     Gy/fraction, 5 times a week, 6 times in the third week; CHT concomitant with RT (2 cycle of~     Cisplatinum and Vinorelbine, every 21 days). Feasibility of the studied approach is evaluated~     by scoring the toxicity during RT-CHT and therafter, as well as percentage of treatment~     completion; efficacity is evaluated by estimation of local control and survival. If toxicity~     and efficacity are similar or better than those observed in modern series of conventionally~     fractionated RT-CHT, the studied regimen will become a routine treatment schedule in our~     institution in order to spare RT resources. In the future, a randomized comparison of the~     studied schedule with conventionally fractionated RT-CHT for locally advanced NSCLC is also~     planned.~   "
91659|NCT02367430|"~     The purpose of this study is to investigate whether a well-established case management model~     called Critical Time Intervention (CTI) can help individuals with hoarding disorder who are~     concerned about the risk of eviction. Each individual with hoarding disorder will be assigned~     to work with a CTI Specialist for 9 months, who will provide referrals for mental health~     treatment, legal consultations, and registration for entitlements. All participants will be~     offered a facilitated group intervention called the Buried in Treasures Workshop. The CTI~     Specialist will also facilitate reconnecting the individual with supportive family/friends~     and will monitor and support the de-cluttering of the patient's home.~      A second comparison group will be offered the same group intervention (Buried in Treasures~     Workshop) without the other parts of the CTI protocol.~   "
91660|NCT02367417|"~     The objective of this study is to collect outcome information on patients requiring Total~     Knee Replacement (TKR) in primary or revision cases and therefore receiving the LINK®~     Endo-Model® SL® under routine conditions.~   "
91661|NCT02367404|"~     Objectives:~      Primary: Comparison of proportion of patient achieving continence between the four arms at 6~     months.~      Secondary:~        -  Comparison of time to achieve continence between the four arms.~        -  Comparison of urinary symptoms and quality of life improvement between the four arms.~        -  Assessment of adverse events in Duloxetine arms.~      Primary outcome/ time frame: Proportion of patient achieving continence at 6 months.~     Continence is defined as using no pador only security pad.~      Secondary outcome:~        -  time to achieve continence~        -  Quality of life tested in relation to incontinence according to Visual Analog Scale~          (VAS) and King's Health Questionnaire (KQH).~        -  Urinary symptoms measured with International Prostate Symptom Score (IPSS).~      No. of subjects entered: 300 patients informed and included, 240 patients will be randomized.~      Statistical methods~        -  Proportion of patients who achieve continence and time to achieve continence will be~          compared between the four arms.~        -  Comparison of quality of life outcomes between the four arms~        -  Comparison of clinical variables that can affect the primary/secondary outcome -~          univariate and multivariate analysis (ITT).~   "
91662|NCT02367391|"~     This study is evaluating the feasibility and short term smoking cessation outcomes of an~     automated smoking cessation intervention delivered via mobile phone text messaging as an~     adjunct to Varenicline in a primary care setting.~   "
91663|NCT02367378|"~     The purpose of this study is to collect information on the effect of minimally invasive spine~     tumor decompression on treated patients. This treatment option is less invasive that the~     standard surgical decompression and is expected to result in better wound healing, decreased~     tissue trauma, and decreased pain after surgery.~   "
91664|NCT02367365|"~     Neovascular Age-Related Macular Degeneration (NV AMD) remains the leading cause of vision~     loss among people over 65. Intravitreal injections with drugs that block VEGF have~     revolutionized treatment of NV AMD. However, less than 40% of treated patients have~     clinically significant imporovement in vision. In this study, we will determine the relative~     frequency of neovascular subtypes in two groups: 1) a representative, treatment-naive NV AMD~     patient population, and 2) a population of patients who develop recurrent NV AMD activity~     while off treatment and assess the frequency of persistent disease activity (PDA) according~     to specific neovascular morphologic subtypes. This information will clarify the scope of the~     PDA problem and will identify patients with PDA who may benefit from additional therpeutic~     strategies.~   "
91665|NCT02367352|"~     The purpose of this study is to evaluate the safety and tolerability and determine the MTD to~     subsequently define an RP2D of alisertib in combination with weekly paclitaxel in East Asian~     patients with advanced solid tumors.~   "
91666|NCT02367339|"~     Evaluation of the prevalence of ESBL-Enterobacteriaceae colonization among ICU staff~   "
91683|NCT02367105|"~     The prevalence of obesity in Veterans is greater than in the general population, and even~     more so among users of the VA Health Care System. In addition, the population of obese older~     Veterans is rapidly increasing as more baby boomers become senior citizens. In older~     Veterans, obesity exacerbates the age- related decline in physical function and causes~     frailty which predisposes to admission to a VA chronic care facility. However, the optimal~     clinical approach to obesity in older adults is controversial because of the concern that~     weight loss therapy could be harmful by aggravating the age-related loss of muscle mass and~     bone mass. In fact, the MOVE (Managing Overweight/Obese Veterans) program does not have any~     guidelines for eligible Veterans if they are 70 or older. It is possible that the addition of~     testosterone replacement to lifestyle therapy will preserve muscle mass and bone mass and~     reverse frailty in obese older Veterans and thus prevent their loss of independence and~     decrease demand for VA health care services.~   "
91667|NCT02367326|"~     Inflammatory bowel disease (IBD) groups together Crohn's Disease (CD) and ulcerative colitis~     (UC). Its prevalence is high representing approximately 0.4% of the population. The peak~     incidence for these diseases ranges between 2 and 30 years of age with a second peak for CD~     recently reported at 60. These diseases develop over time into complications requiring in 2/3~     of cases surgical resection procedures in CD and colectomy in over 20% of cases. Cohort data~     has recently shown that the early use of azathioprine from the first year would decrease the~     need for surgery. Aside from biologics, azathioprine is the most widely used~     immunosuppressant in IBD management. Its metabolism is highly variable in the overall~     population since over 10% of patients are slow metabolizers and 15% fast metabolizers. This~     explains partly treatment failures and side effects with thiopurines. A lot of research has~     shown that metabolite measurement of azathioprine (6-TGN end methylated derivatives) could be~     used clinically even if these results remain controversial. In fact, their positive~     predicative value (PPV) in clinical response does not exceed 60%. This costly testing cannot~     be done everywhere, is not reimbursed by national health services, and may not be used in~     some countries. It is, however, key in order optimize these drugs at a time when only two~     anti-TNFs are possible in the event of failure on thiopurines. Older studies have shown that~     MCV and lymphonenia could be markers for thiopurine impregnation. Recently, an American study~     provided a mathematic formula enabling to achieve over 80% PPV for the clinical response on~     AZA but this calculation needs to be confirmed and it is, moreover, patented (costly).~   "
91668|NCT02367313|"~     This Phase 2 protocol is designed to compare two dose levels of Vapendavir versus placebo.~     The objectives are to obtain safety and efficacy data in moderate to severe asthmatic~     patients, aged 18 to 75 years at risk of loss of asthma control due to presumptive Human~     Rhinovirus infection.~   "
91669|NCT02367300|"~     A prospective, non-randomized trial to validate the database of brain electrical activity~     recordings and clinical information collected from patients who present to the ED following~     closed head injury.~   "
91670|NCT02367287|"~     Although the diet of the US population meets or exceeds recommended intake levels of most~     essential nutrients, the quality of the diet consumed by many Americans is sub-optimal due to~     excessive intake of added sugars, solid fats, refined grains, and sodium. The foundations and~     outcomes of healthy vs. unhealthy eating habits and activity levels are complex and involve~     interactions between the environment and innate physiologic/genetic background. For instance,~     emerging research implicates chronic and acute stress responses and perturbations in the~     Hypothalamic-Pituitary-Adrenal axis in triggering obesity-promoting metabolic changes and~     poor food choices. In addition, the development of many chronic diseases, including~     cardiovascular disease, diabetes, cancer, asthma and autoimmune disease, results from an~     overactive immune response to host tissue or environmental antigens (e.g. inhaled allergens).~     A greater understanding is needed of the distribution of key environment-physiology~     interactions that drive overconsumption, create positive energy balance, and put health at~     risk.~      Researchers from the USDA Western Human Nutrition Research Center are seeking volunteer study~     participants for a cross-sectional metabolic phenotyping study of healthy people in the~     general population. Observational measurements include the interactions of habitual diet with~     the metabolic response to food intake, production of key hormones, the conversion of food~     into energy: the metabolism of fats, proteins, and carbohydrates, characteristics of the~     immune system, stress response, gut microbiota (bacteria in the intestinal tract), and~     cardiovascular health. Most outcomes will be measured in response to a mixed~     macronutrient/high fat challenge meal.~   "
91671|NCT02367274|"~     A prospective, non-randomized trial for the extension and replication of the development~     database of brain electrical activity recordings and clinical information collected from~     patients who present to the ED following closed head injury.~   "
91672|NCT02367261|"~     The current prospective clinical study's aim is to determine ABT's SPI implant survival rate,~     crestal interproximal bone resorption during 24 months post implant insertion and to~     assimilate the drilling sequence during the clinical use of SPI implants.~   "
91673|NCT02367248|"~     The main purpose of this study is to determine whether deferoxamine and xingnaojing injection~     is effective and safe as a treatment for intracerebral hemorrhage.~   "
91674|NCT02367235|"~     The purpose of this study is to evaluate the efficiency of the Colpassist vaginal positioning~     device during robotic-assisted sacrocolpopexy.~   "
91675|NCT02367222|"~     The purpose of this database study is to assess if Arepanrix™ vaccination during the 2009~     pandemic was associated with an increased risk of multiple sclerosis (MS) in Manitoba,~     Canada.~   "
91676|NCT02367209|"~     In the recent years a novel method for functional lung imaging called Fourier decomposition~     MRI (FD MRI) has been introduced that allows for simultaneous assessment of regional lung~     perfusion and ventilation-related information without exposure to ionizing radiation or~     administration of intravenous or inhalational contrast agent. In this project, the~     investigators plan to investigate whether Fourier decomposition (FD) MRI is able to provide~     similar clinical information on regional lung perfusion as the standard methods SPECT/CT and~     DCE MRI in patients with COPD.~   "
91677|NCT02367196|"~     CC-90002-ST -001 is an open-label, Phase 1, dose escalation and expansion clinical study in~     subjects advanced, refractory solid and hematologic cancers.~   "
91678|NCT02367183|"~     This study is design to explore the effect of GED-0301 on clinical and endoscopic outcome and~     to evaluate its safety in subjects with active Crohn's disease.~   "
91679|NCT02367170|"~     Investigators will assess the effect of exercise on markers of inflammation and protein~     catabolism. This research study will further our understanding of how treating Chronic~     Critical illness (CCI) - related respiratory muscle weakness with strength training can not~     only improve muscle function, but also potentially blunt the inflammation and catabolism of~     Peristent Inflammation/Immunosuppression and Catabolism (PICS).~   "
91680|NCT02367157|"~     The purpose of this study is to determine how the applications of Kinesio Tape affect the~     morning stiffness in patients with rheumatoid arthritis.~   "
91681|NCT02367131|"~     Study to investigate the safety and efficacy of daily use of JARDIANCE® Tablets in Japanese~     elderly patients with type 2 diabetes mellitus.~   "
91682|NCT02367118|"~     The purpose of this study is to determine whether prednisone is effective in the treatment of~     chronic rhinosinusitis without nasal polyps in adult patients.~   "
91687|NCT02367053|"~     The trial is a randomized, double-blind First in Human trial to evaluate the safety and~     tolerability of ZP4207 in healthy volunteers (HV) and in insulin-induced hypoglycemic T1D~     (type 1 diabetes) subjects as compared to native glucagon. The trial includes two parts.~      Part 1 includes dose escalation of ZP4207 in cohorts of 8 subjects. In each cohort, subjects~     will be randomized 3:1 to receive either a single ascending dose of ZP4207 (6 subjects) or a~     single fixed dose (SD) of native glucagon (2 subjects). The doses will be administered s.c.~     in 4-5 cohorts and i.m. in 3 cohorts.~      Part 2 includes two sequence groups of 10 hypoglycemic T1D subjects. The subjects will be~     treated with fixed single doses of ZP4207 and native glucagon s.c. in a sequential cross-over~     design in a randomized treatment order.~   "
91688|NCT02367040|"~     The purpose of this study is to evaluate whether copanlisib in combination with rituximab is~     superior to placebo in combination with rituximab in prolonging progression free survival~     (PFS) in patients with relapsed iNHL who have received one or more lines of treatment,~     including rituximab and who either had a treatment-free interval of ≥ 12 months after~     completion of the last rituximab-containing treatment, or who are unwilling to receive~     chemotherapy/for whom chemotherapy is contraindicated on reason of age, comorbidities, and/or~     residual toxicity.~   "
91689|NCT02367027|"~     Rivaroxaban is a substance developed for use in the treatment of blood coagulation~     disorders.Thrombosis (blood clots) can occur as a result of excessive coagulation activity in~     the blood vessels. Excessive coagulation activity can occur in children as well, and~     rivaroxaban is therefore being developed for the treatment of thromboembolic events in~     children and adolescents. As small children are often unable to swallow tablets, an oral~     suspension (mixture of a liquid containing finely distributed solids) has been developed~     which allows dosing according to body weight.The objective of this trial is to compare the~     bioavailability (proportion of a substance that remains available unchanged in the blood~     circulation) of a new oral suspension of rivaroxaban with a previously used oral suspension~     and with a rivaroxaban tablet approved for treatment. In order to evaluate the potential~     influence of food, the new oral suspension containing 20 mg rivaroxaban will be taken after~     consuming food. In addition, the pharmacokinetics (concentrations of the drug and breakdown~     products (metabolites) in blood), safety and tolerability will be assessed.~   "
91690|NCT02367014|"~     This study will be a Phase 1/2, multi-center, randomized, double-blind, multiple ascending~     dose, placebo-controlled study, enrolling an anticipated 36 subjects with mitochondrial~     myopathy associated with genetically confirmed mitochondrial disease to evaluate the safety,~     tolerability, pharmacokinetics (PK), and preliminary efficacy of MTP-131 in this patient~     population.~   "
91691|NCT02367001|"~     Our goal is to evaluate, in France, the effectiveness (in terms of participation) of the~     general practitioner involvement (signature) and a more personalized communication in~     invitation letters to organized screening of breast, colorectal and cervical cancers.~      The hypothesis on which this project is based is that communication is probably more~     effective if the receiver feels personally targeted by invitation letters (Dear Martin, I~     am writing ...) and if he knows the issuer (his general practitioner rather an unknown~     person).~   "
91692|NCT02366988|"~     Biliary obstruction complicates the course of chronic pancreatitis in 3%-23% of patients and~     in these cases, endoscopy and surgery are the treatment modalities of choice.~     Morbid-mortality of these procedures is similar and physicians face the decision between~     endoscopy and surgery for this group of patients, with no randomized controlled trial~     available comparing these procedures.~      The PASTEC trial is a multicenter, phase III, randomized, comparing the effectiveness of~     surgical and endoscopic interventions in the management of bile duct stricture for chronic~     pancreatitis.~      The primary end point is 18-months normalization of serum alkaline phosphatase. Secondary end~     points are morbid-mortality rate, quality of life, numbers of endoscopic or surgical~     procedures, length of stay. Eighty-six patients need to be included.~   "
91693|NCT02366975|"~     There are many evidences in the literature showing that the metabolic syndrome (MetS) is~     associated with BPH / LUTS. There are also numerous evidence that hypogonadism is associated~     with both conditions, thus being one of the most probable pathogenetic factor underlying the~     association between MetS & BPH / LUTS.~      Preliminary evidences from observational clinical studies have shown that treatment with~     testosterone replacement in hypogonadal patients with MetS reduces the symptoms of lower~     urinary tract symptoms (LUTS) associated with BPH. Preclinical studies performed by the~     investigators research group show in an experimental model of metabolic syndrome the~     occurrence of marked inflammation and tissue remodeling of the prostate gland, which is~     prevented by treatment with testosterone replacement (Vignozzi et al., 2012). There is~     therefore a need for a clinical trial to demonstrate the effect of treatment with~     testosterone replacement in reducing the inflammation of the prostate and its effectiveness~     in improving the symptoms related to inflammation in patients with prostatic BPH associated~     with metabolic syndrome and testosterone deficiency .~      The aims of the present study is to evaluate the effectiveness of testosterone replacement~     therapy compared to placebo in reducing signs and symptoms of inflammation of the prostate~     and LUTS symptoms in hypogonadal patients with metabolic syndrome and BPH who are candidates~     for radical prostatectomy simple.~      For this purpose both clinical (assessment of specific symptoms of prostatitis assessed by~     questionnaire National Institutes of Health Chronic Prostatitis Symptom Index, NIH-CPSI and~     assessment of the symptoms of LUTS and questionnaires International Prostate Symptom Score,~     IPSS), ultrasound (transrectal ultrasound evaluation of markers of prostatic inflammation:~     macrocalcifications, inhomogeneity etc.), biochemical (evaluation of inflammatory cytokines~     in the semen), urodynamic and histology (histomorphometric and immunohistochemical analysis~     of samples prostate derived from patients enrolled in the study or not treated with~     testosterone) scores will be performed. Along with the symptoms and clinical signs of~     prostate inflammation and LUTS, the effect of testosterone therapy or placebo on penile~     erection will be also evaluated.~   "
91694|NCT02366962|"~     The purpose of this study is to confirm the safety until Day 29 after injection of a single~     dose of quadrivalent vaccine ASP7374 in adult subjects aged 20 or older~   "
91695|NCT02366949|"~     Determine the safety, tolerability, maximum tolerated dose (MTD), and recommended Phase 2~     dose (RP2D) of oral BAY 1217389 given in combination with intravenous (IV) paclitaxel using~     an intermittent dosing schedule (2 days on / 5 days off) in subjects with advanced~     malignancies.~   "
91696|NCT02366936|"~     The purpose of this study is to determine the effectiveness of the Tortle Midliner~     positioning system in prevention and/or treatment of dolichocephaly, which can develop in~     preterm infants during the hospital stay.~      Specific Aim: Determine if the use of the Tortle Midliner is a more effective prevention and~     treatment strategy for dolichocephaly than current standard of care intervention in the Duke~     Intensive Care Nursery (ICN).~   "
91697|NCT02366923|"~     The study will explore in vivo lens dehydration rates across a 12hr wear period for the study~     lenses.~   "
91698|NCT02366910|"~     The study will explore in vivo lens dehydration rates across a 12hr wear period for the study~     lenses.~   "
91928|NCT02363868|"~     The purpose of this study is to examine the healthcare costs among patients with CML~     receiving dasatinib or nilotinib as first line therapy in a commercially or Medicare insured~     population.~   "
91699|NCT02366897|"~     The project is aimed at addressing the fundamental issue in antipsychotic therapeutics -the~     balance between mental state benefits and neurological risks.The latter cannot be~     overestimated and clinical skills in themselves are inadequately sensitive to refine~     practice. With all current and pipeline antipsychotics based on central dopamine blockade,~     there is little prospect that therapeutics can be improved by advances in pharmacology alone.~      The project uses, for the first time, technology that is not only simple, real-life and~     user-friendly but modern and socially held in high regards. The proposal depends on~     patients receiving antipsychotic medication where clinically indicated. At all times,~     subjects will receive clinically-indicated therapy. The major ethical issue will relate to~     the issue of informed consent in those suffering from major psychiatric disorder. This is a~     routine consideration in psychiatric practice and the investigators will seek guidance on~     this from the Consultant Psychiatrist responsible for potential participants and would not~     proceed with initial approaches in cases of doubt or absence of capacity.~      This is a pilot/feasibility study with no intention to utilise the data for commercialisation~     of the device or to expand the CE (Conformité Européenne) marking.~   "
91700|NCT02366884|"~     The cell behavior that the investigators regard as malignant, including: cell autonomy;~     invasion and digestion of surrounding normal tissues; migration and colonization of distant~     organs; ability to develop resistance to drugs, temperature, or radiation; and ability to~     kill the host, are not only characteristics of cancer cells, but of pathogenic and/or~     opportunistic unicellular organisms (bacteria, fungi and protozoa). Rudolf Virchow~     (1821-1902), the father of modern pathology, first pointed out the resemblance between the~     biological behavior of cancer cells and that of single-celled organisms when causing~     infections. He thought, incorrectly, that cancer cells were cells infected with bacteria and~     had acquired their pathogenic behavior from them. Others later postulated that the behavior~     of cancer cells was likely due to the re-expression of past traits and behaviors (atavism)~     derived from their past evolutionary experience as independent, single-celled organisms from~     which all cells in multicellular organisms originated. In other words, the behavior of~     pathogenic unicellular organisms, including: unlimited replicative potential; capacity for~     invasion, migration, and metastases; abilities to evade the host's immune system, to generate~     multi-drug resistance; and to kill a host, are what the investigators define as cancer when~     one of the investigators cells re-express these past ancestral traits. This reversion or~     de-evolution of a differentiated cell to its ancestral undifferentiated, unicellular form has~     been named Atavistic Metamorphosis.~      This does not imply that cancer cells are bacteria, protozoa, or yeasts. It means that cancer~     cells express functions and/or behaviors similar to their ancestral parents, the unicellular~     organisms from which our cells originated.~      If this is true, a combination of drugs that are effective to eradicate certain unicellular~     organisms may work in cancer treatment.~      The principal objective of this study is to determine whether there is a benefit for patients~     with advanced, metastatic and terminal cancers to be treated with combinations of selected~     drugs conventionally used in medical practice to kill bacterial, fungal and protozoal cells.~   "
91701|NCT02366871|"~     The study will evaluate the incidence of major bleeding (including clinically relevant~     non-major (CRNM) bleeding) events in women undergoing surgery for gynecologic cancer with~     apixaban 2.5 mg BID compared to current standard of care, subcutaneous enoxaparin 40 mg QD~     for 28 days post surgery.~   "
91702|NCT02366858|"~     The investigators hypothesis is that a 22 gauge needle can yield core tissue, obviating the~     need to use the 19 gauge needle for core tissue procurement.~   "
91703|NCT02366845|"~     This study plans to learn more about transfusion of a human blood component called plasma in~     patients who have liver problems. Patients are asked to be in this study because they have~     liver disease and therefore may require the transfusion of plasma.~      The dose of plasma required to reach certain blood clotting laboratory targets is usually~     determined by clinicians. Due to the complexity of the patient's blood clotting disorder,~     determining the appropriate dose of plasma is very difficult. The investigators have~     developed a dosing table based on information from other patients with liver disease and the~     investigators are testing it to see if it is a more accurate dosing tool then clinician~     chosen dosing of plasma in patients with liver disease who need one or more plasma~     transfusions~   "
91704|NCT02366832|"~     The purpose of this study is to determine if treatment with percutaneous cryoablation yields~     significant differences in the evaluative criteria of Phantom Limb Syndrome (PLS).~   "
91705|NCT02366819|"~     This pilot clinical trial studies genetic analysis-guided irontecan hydrochloride dosing of~     modified fluorouracil, irinotecan hydrochloride, leucovorin calcium, oxaliplatin~     (mFOLFIRINOX) in treating patients with gastroesophageal or stomach cancer that has spread~     from where it started to nearby tissue or lymph nodes. Drugs used in chemotherapy, such as~     fluorouracil, irinotecan hydrochloride, leucovorin calcium, and oxaliplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Leucovorin calcium may also help~     fluorouracil work better. Genetic analysis may help doctors determine what dose of irinotecan~     hydrochloride patients can tolerate.~   "
91706|NCT02366806|"~     This study is being conducted to investigate the effect of a more in-depth education plan for~     patients with breast cancer. Patients will be randomized to receive either the standard~     education plan during their breast cancer treatment or they will receive in-depth education~     about their breast cancer treatment. In order to see what kind of effect the different~     education plans have, patients will fill out three identical questionnaires during the course~     of treatment.~   "
91707|NCT02366793|"~     The potential consequences after breast cancer surgery are joint pain and sensitive~     disorders, the main sign of which is alterations in shoulder mobility. Global kinesitherapy~     has been shown to be effective at increasing shoulder range of motion restriction. However,~     literature does not consider specific manual therapy techniques, which means peripheral~     nerves and articular capsule have not been taken into account. These two tissues are~     potentially damaged structures during surgery and they are main responsible for shoulder~     range of motion restriction The main objective of this study is to pilot the effectiveness of~     accessory joint and nerve mobilization techniques in order to get an overview of the~     articular capsule and nerve dysfunctions involvement in shoulder motion restriction.~   "
91708|NCT02366780|"~     Breast milk is a unique and unmatched nutritional and non-nutritive source of bioactive~     factors for the health and development of infants.Colostrum, which is produced in low~     quantities for the first 3 to 4 days after birth, is rich in immunologic components and~     developmental factors.~      Breastfeeding difficulties during the first days of life of an infant are common. Moreover,~     not all infants can be directly fed at the breast.~      Therefore, breast milk feeding at this early stage is initiated and promoted by the~     expression of breast milk either manually or by use of a pump. Whether the method of milk~     expression at this stage has a qualitative impact on colostrum is currently unknown.~      The purpose of this randomized controlled study is to compare the effect of manual expression~     with electric pump expression upon the macronutrient composition of breast milk.~   "
91710|NCT02366754|"~     The purpose of this study is to address the need for targeted treatments that induce~     functional and structural changes in the brain, ultimately improving neurobehavioral~     functioning, the investigators propose examining the therapeutic effectiveness of repetitive~     Transcranial Magnetic Stimulation (rTMS). The objective is to improve functional recovery for~     persons remaining in vegetative (VS) and minimally conscious (MCS) states 3 to 12 months~     after severe TBI. The approach is to determine the neurobehavioral effect of rTMS, the~     relationship between neurobehavioral changes and net neural effects, and to identify and~     define the neural mechanisms related to neurobehavioral improvements by providing 30 active~     or placebo rTMS sessions.~   "
91711|NCT02366741|"~     Small cell lung cancer (SCLC) harbors a high risk for brain metastases. Prophylactic whole~     brain radiotherapy (PCI)) is the standard treatment for these patients after completing~     chemo-radiotherapy to the chest, with a 5% survival advantage. Recent data suggest minimal~     risk for hippocampal involvement in these patients. There is no published data thus far~     testing the effect of hippocampal sparing during WBRT on the patient's neuro-cognitive~     function, QOL, and survival.., The goals of the proposed study are to assess prospectively~     the neurocognitive changes in patients with LD SCLC who are candidates for PCI before, and~     periodically after PCI~   "
91712|NCT02366728|"~     This randomized phase II study will assess the impact of pre-conditioning on migration and~     survival among newly diagnosed glioblastoma (GBM) patients who have undergone definitive~     resection and completed standard temozolomide (TMZ) and radiation treatment, as well as the~     impact of tetanus pre-conditioning and basiliximab together on survival. After completing~     standard of care radiotherapy with concurrent TMZ, patients will be randomized to 1 of 3~     treatment arms: 1). receive cytomegalovirus (CMV)-specific dendritic cell (DC) vaccines with~     unpulsed (not loaded) DC pre-coinditioning prior to the 4th vaccine; 2). receive CMV-specific~     DC vaccines with Tetanus-Diphtheria Toxoid (Td) pre-conditioning prior to the 4th vaccine;~     3). receive basiliximab infusions prior to the 1st and 2nd DC vaccines along with Td~     pre-conditioning prior to the 4th vaccine. A permuted block randomization algorithm using a~     1:1:1 allocation ratio will be used to assign patients to a treatment arm. Randomization will~     be stratified by CMV status (positive, negative), with the assignment to arms I and II being~     double-blinded. Effective March 2017, randomization to Group III has been terminated.~   "
91713|NCT02366715|"~     Bronchiolitis is an acute lower airway infection caused by a viral infection. It is a major~     cause of winter admissions to pediatric wards. Accepted therapies include oxygen support and~     IV fluids, whereas other supportive therapies such as inhalations are of questionable~     benefit. Moderate to severe cases are a source of distress to patient, parents and medical~     staff often necessitating Pediatric Intensive Care Unit admission. Heated Humidified High~     Flow Nasal Cannula (HHHFNC) therapy has been shown lately to improve the work of breathing,~     oxygen saturation, and CO2 pressure (PCO2) values as well as decrease PICU admissions and~     intubation rates. We planned a prospective and retrospective study in order to check the~     feasibility of using HHHFNC in a primary pediatric ward and its effect on clinical well~     being, respiratory status and PICU admission.~   "
91714|NCT02366702|"~     The purpose of this descriptive and exploratory pilot study is to investigate: (1) sagittal~     plane hip kinematics and kinetics and (2) metabolic consumption/cost, for bilateral~     transfemoral walking with passive prostheses versus powered prostheses. The pilot study will~     collect data from three subjects with bilateral transfemoral amputations. Differences in~     kinetics, kinematics, and oxygen consumption/cost when comparing passive and powered~     components may indicate benefits for clinical application of powered devices for persons with~     lower limb amputation.~   "
91715|NCT02366689|"~     The objective of this clinical research study is to assess the efficacy of a commercially~     available triclosan/copolymer toothpaste compared to a commercially available oral hygiene~     multi-component regimen encompassing the use of a manual toothbrush, a toothpaste containing~     stannous fluoride / sodium hexametaphosphate and a mouthwash containing cetylpyridinium~     chloride relative to a negative control regimen in reducing established dental plaque and~     gingivitis over three and six months of assigned product use.~   "
91716|NCT02366676|"~     The purpose of this study is to evaluate the efficacy of Combined Intravesical Therapy With~     Hyaluronic Acid and Chondroitin Sulphate in the Treatment of Recurrent Cystitis Refractory to~     Escherichia Coli Extract~   "
91717|NCT02366663|"~     This randomized phase III trial studies 90-yttrium ibritumomab tiuxetan and combination~     chemotherapy compared with combination chemotherapy alone before stem cell transplant in~     treating patients with diffuse large b-cell non-Hodgkin lymphoma that has returned after a~     period of improvement. Radioactive substances linked to monoclonal antibodies, such as~     90-yttrium ibritumomab tiuxetan, can bind to cancer cells and give off radiation which may~     help kill cancer cells. Drugs used in chemotherapy, such as carmustine, etoposide phosphate,~     cytarabine, and melphalan (BEAM), work in different ways to stop the growth of cancer cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. It is not yet known whether 90-yttrium ibritumomab tiuxetan and BEAM before a stem~     cell transplant are more effective than BEAM alone in treating patients with diffuse large~     b-cell non-Hodgkin lymphoma.~   "
91718|NCT02366650|"~     The purpose of this prospective, non-interventional clinical study is to assess the clinical~     validity of a number of markers (including Heparin Binding Protein (HBP), Procalcitonin~     (PCT), C-reactive protein (CRP), White cell count (WCC) and lactate) for indicating the~     presence of organ dysfunction, or outcome, of patients with organ dysfunctions following~     emergency department admission or hospitalization. Secondary objectives are to identify novel~     putative biomarkers and to identify risk factors for negative long-term effects of acute~     critical illness The HBP assay is an enzyme-linked immunosorbent assay (ELISA) for the~     quantitative determination of Heparin Binding Protein in human plasma.~   "
91719|NCT02366637|"~     This study proposes to evaluate the safety and efficacy of PF-03715455 in subjects with~     moderate to severe Chronic Obstructive Pulmonary Disorder.~   "
91750|NCT02366221|"~     The specific aim of the study is to obtain long-term follow-up information on patients who~     have completed their standard clinical care in the Orthopaedic Hand and Upper Extremity~     Service. The study will help to qualify and quantify long-term recovery and outcomes from~     uncommon upper extremity fractures, as well as non-fracture bone and joint conditions. The~     hypotheses vary, but generally focus on the patterns of injury, the results of treatment and~     the complications encountered.~   "
91720|NCT02366624|"~     The purpose of this study is to evaluate the effect of bariatric surgery in bile acid~     homeostasis and its interrelationship with the metabolic changes induced by the surgery.~      This study contemplates the following hypothesis:~        -  Bariatric Surgery induce a new study state in bile acid homeostasis with higher bile~          acid synthesis in association with increased bile acid content.~        -  The major effects of bariatric surgery on bile acid synthesis and is observed one month~          after surgery with a progressively decline during the first year of follow-up.~        -  Gastric bypass increases serum bile acid content, postprandial plasma bile acid response~          and fecal bile acid excretion.~        -  Serum bile acids changes induced by gastric bypass are positively correlated with~          changes in gastric inhibitory polypeptide (GIP) levels and postprandial concentration of~          insulin and glucagon like peptide-1 (GLP-1) and inversely correlated with thyrotropic~          hormone (TSH) and postprandial concentration of glucose.~        -  Changes in postprandial plasma bile acid response induced by gastric bypass positively~          correlates with changes in postprandial concentration of insulin, GLP-1 and peptide YY~          (PYY) and inversely correlates postprandial response of ghrelin and glucose.~   "
91721|NCT02366611|"~     The purpose of this study is to determine if Transcranial Direct Current Stimulation (tDCS)~     can reduce pain perception associated with the effects of receiving definitive radiation~     therapy or chemoradiotherapy in head and neck cancer (HNCa) patients.~   "
91722|NCT02366598|"~     The objectives of this trial are to assess the health benefits of acute hemp protein~     consumption compared to soybean protein and a non-protein control on: 1) blood glucose,~     appetite and blood pressure for one hour following consumption, 2) food intake at an ad~     libitum meal one hour following consumption and 3) blood glucose, appetite and blood pressure~     following the ad libitum meal to determine the second meal effect of hemp protein.~   "
91723|NCT02366585|"~     The main purpose of the trial is to investigate the effect of locally delivered ciclosporin~     as an adjunct to non-surgical mechanical debridement in the treatment of chronic~     periodontitis and to compare it to mechanical debridement alone.~   "
91724|NCT02366572|"~     The objectives are to test the acute effects of different cereals containing pulse~     ingredients on: 1) post-prandial blood glucose, insulin and appetite for two hours, and 2)~     food intake two hours following consumption of pulse products.~      We hypothesize that cereals containing pulse ingredients will lead to lower blood glucose,~     insulin, appetite and food intake responses compared to non-pulse cereals.~   "
91725|NCT02366559|"~     The primary objective of this study is to compare the efficacy and risk of adverse events of~     electrocautery versus 532 nm Q-switched neodymium-doped yttrium aluminium garnet (Nd:YAG)~     laser for the treatment of flat seborrheic keratoses.~      This study is a pilot study designed to determine feasibility of these procedures.~   "
91726|NCT02366546|"~     Following pre-treatment with cyclophosphamide and/or fludarabine, NY-ESO-1-specific TCR gene~     transduced T lymphocytes are transferred to the patients with NY-ESO-1-expressing solid~     tumors.~   "
91727|NCT02366533|"~     The goal of ATN 093 is to determine program-level factors associated with the effectiveness~     of SMILE in Caring for Youth Linkage-to-Care (LTC) program network at the 15 Adolescent~     Medicine Trial Units (AMTU). This will be accomplished by evaluating and categorizing the~     various LTC programs at the AMTUs and then examining the association between the LTC program~     characteristics (providers, practices, and systems) and the proportion of Human~     Immunodeficiency Virus (HIV)-infected youth, ages 12-24 years old, inclusive, linked to care~     and maintained in care. As such, this study focuses on LTC programs at the AMTUs as the unit~     of analysis and not the youth themselves.~   "
91728|NCT02366520|"~     The purpose of this study is to determine whether a handheld mirror helps to reduce child~     behavior problems during dental treatment. It will be tested by randomized crossover design.~     Child participants will receive dental treatment under two conditions: during one of the~     treatment days the child will be given a handheld mirror; another treatment will be done~     without the child having the mirror. Each condition will be assign on separate days, and the~     day, which the child has the mirror, will be assigned by chance.~   "
91729|NCT02366507|"~     Traditional devices to measure blood pressure include automatic sphygmomanometer (pressure)~     cuff systems or manual blood pressures obtained by auscultation (listening with a~     stethoscope). Both these techniques fail to provide accurate and consistent blood pressure in~     the hypotensive (low blood pressure) state, which is often encountered in emergency~     departments and intensive care units. Alternately, invasive arterial pressure measurement is~     time-intensive, painful, expensive, and risks include bleeding, infection, and neurovascular~     injury.~      In clinical practice, the Doppler velocimetry system is occasionally used in hypotensive,~     critically-ill patients when an immediate systolic blood pressure measurement is vital for~     clinical and therapeutic management. With a technique similar to that used to obtain a manual~     blood pressure, the Doppler velocimetry system can be used in place of the auscultation of~     the brachial pulse to accurately determine the systolic blood pressure. It is currently~     unknown whether additional information can be obtained by evaluation of the Doppler waveform~     in healthy vs. critically-ill patients. The goal is this project is to digitally record~     Doppler waveforms of critically-ill patients in the Emergency Department (ED) via a standard~     8MHz (fetal) Doppler probe, correlate the Doppler readings with current blood pressure and~     heart rate, and determine if waveform shapes and parameters are predictive of hemodynamic~     compromise.~   "
91730|NCT02366494|"~     Identify exosomal micro RNA that predict responses to ADT~   "
91731|NCT02366481|"~     Given that glutamate carboxylation or decarboxylation is key to the metabolic role of~     osteocalcin (at least in mouse models) and that carboxylation is vitamin K dependent, it is~     critical to isolate the effect of vitamin K manipulation on carboxylation of osteocalcin and~     its subsequent effect on glucose metabolism in clinical trials. The purpose of this~     randomized, double-blind, placebo-controlled clinical trial in adults is to determine whether~     eight weeks of daily supplementation with vitamin K2 (menaquinone-7) can improve markers in~     blood associated with diabetes risk.~   "
91732|NCT02366468|"~     The purpose of this study is to demonstrate that the change of best corrected visual acuity~     (BCVA) is comparable in patients treated with ranibizumab at the discretion of the~     investigator vs. treatment according to a standard of care scheme (pro re nata, as needed).~   "
91733|NCT02366455|"~     The right-sided double lumen endobronchial tube (R-DLT) is seldom. The principal cause of~     reticence for using the R-DLT are the difficult positioning of its lateral orifice in front~     of the origin of the right upper lobe (RUL) and the variability of the length of the right~     main stem bronchus (RMSB). Both the angle between the right upper lobe (RUL) bronchus origin~     and the RMSB and the length of the RMSB can be measured with high resolution CT-scan. These~     measures can be useful in clinical practice as they help to determine when a R-DLT should not~     be used or used with caution when facing a large variation of the angle of the RUL or a~     proximal implantation of a RUL bronchus .~   "
91734|NCT02366442|"~     The overarching goal of the proposed study, named SYNERGY, is to explore relationships among~     balance performance, cognitive function, affective dysregulation, as they relate to the~     community re-integration in Veterans with TBI. The SYNERGY study findings can aid in the~     development of a better outcome models for the clinicians in facilitating effective community~     re-integration in Veterans with TBI~   "
91735|NCT02366429|"~     Randomized controlled trial evaluating an Internet-delivered Cognitive Behavioral Therapy~     (ICBT) adapted for pregnant women suffering from antenatal depression. The ICBT-program will~     be added to treatment as usual (TAU) and compared to TAU only.~      Participants (n=60) are recruited from all over Sweden (only Swedish citizens can~     participate) and are assessed and treated on a distance via a secure web platform and~     telephone.~   "
91736|NCT02366416|"~     The aim of this study is to investigate the effects og physical exercise on bloodglucose and~     pain from the musculoskeletal system in patients with type 2 diabetes.~      The patients will be recruited to 12 weeks of exercise twice weekly. The outomes are long~     term bloodglucose (HbA1c) and pain reported in questionaires. In data analyses the patients~     will be stratified to patients with a high or a low degree of complications related to~     diabetes.~   "
91737|NCT02366403|"~     Post traumatic stress disorder (PTSD) is a condition that develops as a result of exposure to~     a traumatic event. The purpose of this study is to determine whether a breathing meditation~     technique (Sudarshan Kriya Yoga; SKY) provides a treatment benefit that is as effective as~     the standard intervention. Patients' PTSD symptoms will be monitored before treatment, at the~     end of treatment, one month after treatment and 12 months after treatment.~   "
91738|NCT02366390|"~     The purpose of this trial is to determine whether a minimal homebased psychoeducative~     intervention is effective in management of anxiety and dyspnea in patients with severe~     chronic obstructive pulmonary disease.~   "
91739|NCT02366377|"~     The purpose of this study is to evaluate the efficacy and safety of 3 different doses of~     SHR3824 compared with placebo in patients with type 2 diabetes mellitus who are receiving~     treatment with metformin monotherapy (ie, treatment with a single drug) and have inadequate~     glycemic (blood sugar) control.~   "
91740|NCT02366364|"~     The purpose of this study is to assess the safety and tolerability of multiple oral (PO)~     ascending doses of NRX-1074 in normal healthy volunteers.~   "
91741|NCT02366351|"~     The purpose of this study is to obtain information on PK/PD, efficacy and safety of SHR3824~     over 12 weeks in Chinese patients with Type 2 Diabetes. This will be done by comparing the~     effect of SHR3824 to placebo when given in oral doses.~   "
91742|NCT02366338|"~     Atrial fibrillation is the major cause of acute ischemic stroke. The risk of stroke was shown~     to decline by oral anticoagulant therapy. The investigators intended to evaluate appropriate~     use of anticoagulants in non-valvular AF patients.~   "
91743|NCT02366325|"~     The purpose of this study is to evaluate the safety,efficacy, pharmacodynamics (PD), and~     pharmacokinetics (PK) of multiple intravenous doses of EPO-018B in participants with chronic~     kidney disease (CKD) who are on hemodialysis.~   "
91744|NCT02366312|"~     The purpose of this study is to determine how well a daily dose of 150 mg of Erivedge~     (vismodegib) reduces Keratocystic odontogenic tumor (KCOT) size, and to evaluate the safety~     of this dose. Erivedge is FDA-approved for use in adults with a specific type of skin cancer.~     However, the drug is experimental for patients with KCOT.~   "
91745|NCT02366299|"~     Assessment of sedative effects of dexmedetomidine and propofol on the clinical course of~     delirium and neuroinflammation in patients with SIRS using CAM-ICU scale and protein S100b in~     serum.~   "
91746|NCT02366286|"~     The prevalence of hepatitis B virus (HBV) and hepatitis C virus (HCV) in the United States~     (US) is relatively low. However, immigrant populations in the US from Asia and sub-Saharan~     Africa have substantially higher prevalence than the general population and are consequently~     at a significant risk for hepatocellular carcinoma (HCC). Indeed, the age-adjusted incidence~     rates for HCC in the US have tripled from 1975 to 2005. As the population demographics have~     changed, the 2000 US census estimated the number of Somalis in Minnesota at 25,000 but~     current estimates put the number at around 50,000 due to primary refugee arrivals as well as~     secondary immigration from other states. There is no available data for Somali immigrants in~     the US on HBV and HCV prevalence, HBV and HCV genotypes/subgenotypes, and genetic and~     immunologic risk factors predisposing Somalis to HBV and HCV and the subsequent development~     of HCC. Therefore. this study will fill these gaps in the Somali population to understand the~     relative importance of HBV and HCV infections in causation of HCC.~   "
91747|NCT02366273|"~     Patients with psoriasis will be evaluated. The investigators will collect personal history,~     concomitant diseases and in particular the presence of type 2 diabetes mellitus, impaired~     fasting glucose and impaired glucose tollerance. The aim of the study will be to evaluate if~     there is a correlation among inflammation, insulin-resistance and psoriasis.~   "
91748|NCT02366247|"~     This trial is to assess the efficacy and safety of Polyethylene Glycol thymosin alpha1~     (PEG-Tα1), a new long immunomodulator (Category 1.1 of Chemical Drugs) being developed from~     Hansoh Pharmaceutical of China, in combination with adefovir in HBeAg-positive patients with~     chronic hepatitis B.~   "
91749|NCT02366234|"~     AIM:~      The aim of this study is to assess whether patients with an acute distal tubercle fracture of~     the scaphoid treated with a removable brace for 4 to 6 weeks have the same level of symptoms~     and disability 6 months after injury as the average for the normal population.~      NULL HYPOTHESIS:~      Patients with an acute distal tubercle fracture of the scaphoid have Quick DASH (Disabilities~     of the Arm Shoulder and Hand) scores at or above the population norm (a score of 13 in Norway~     and 10.9 in the United States) 6 months after injury when treated symptomatically with a~     removable brace.~   "
91753|NCT02366182|"~     Failed intubation and ventilation in obstetrics remains one of the most common causes of~     death directly related to anesthesia. The reported incidence of failed intubation in~     obstetrics is 1:300, which is significantly higher than that in the non-obstetric population.~     A clinical screening test with high sensitivity and specificity for prediction of difficult~     airway may help reduce morbidity and mortality from general anesthesia. Few studies have~     identified increased neck circumference as the best single predictor of problematic~     intubation. However the cutoff point of this test for identifying patients at high risk of~     difficult intubation is not clear.~      The aim of this study is to determine the optimal cutoff point, which validates prediction of~     difficult ventilation and/or intubation for obstetric patients. Preoperative airway~     assessment will be done including neck circumference. Intraoperative difficult ventilation~     and/or intubation will be recorded. Optimal cutoff point of neck circumference will be~     calculated by Receiver Operating characteristics (ROC) curve.~   "
91754|NCT02366169|"~     This registry is intended as an observational, post-marketing surveillance tool. The registry~     allows collection of baseline demographics and user experience of the commercially available~     MUSE system. Data collection aims to aggregate a minimum of 3 years follow-up on a large~     number of subjects during use outside the constraints of a prescribed clinical study.~   "
91755|NCT02366156|"~     This study will evaluate the effects of encapsulated botanical extracts, previously shown to~     inhibit the enzyme diacylglycerol-acyltransferase-1 (DGAT-1) in vitro, on fasting and~     postprandial lipid metabolism during an oral fat tolerance test (OFTT) in apparently healthy,~     overweight and obese adult men and women.~   "
91756|NCT02366143|"~     This randomized, open-label study will evaluate the safety and efficacy of atezolizumab (an~     engineered anti-programmed death-ligand 1 [PD-L1] antibody) in combination with~     carboplatin+paclitaxel with or without bevacizumab compared with treatment with~     carboplatin+paclitaxel+bevacizumab in chemotherapy-naïve participants with Stage IV~     non-squamous NSCLC. Participants will be randomized in a 1:1:1 ratio to Arm A~     (Atezolizumab+Carboplatin+Paclitaxel), Arm B~     (Atezolizumab+Carboplatin+Paclitaxel+Bevacizumab), or Arm C~     (Carboplatin+Paclitaxel+Bevacizumab).~   "
91757|NCT02366130|"~     The goal of this clinical research study is to learn if Xofigo® (also called Ra-223~     dichloride) combined with hormone therapy and denosumab can help to control breast cancer~     that has spread to the bones and/or bone marrow. The safety of this study drug combination~     will also be studied.~      This is an investigational study. Denosumab and the hormone therapies used in this study are~     FDA-approved and commercially available for the treatment of metastatic breast cancer. Ra-223~     dichloride is FDA-approved and commercially available for the treatment of bone metastases.~     It is considered investigational to use the combination of Ra-223 dichloride, hormone therapy~     and denosumab to treat patients with bone cancer that has spread to the bones.~      The study doctor can explain how the study drugs are designed to work.~      Up to 36 participants will be enrolled in this study. All will take part at MD Anderson.~   "
91758|NCT02366117|"~     The study design is that of a cluster randomised controlled trial~      The aims of the study were: 1) to assess the quality of care of the residential units for~     people with long-term mental disorders; 2) to design a training intervention for the staff of~     the units in the intervention group; 3) to assess the effectiveness of the intervention 4 and~     8 months after it ended.~      The main outcome variable was level of activity of the users. Secondary outcome variables~     were the QuIRC dimensions.~      The selection of the sample was by residential units for people with long-term mental~     disorders.~      The inclusion criteria were all the middle and high-support residential units in Portugal.~     Units that had only one type of service users (e.g., mental retardation, dementia) were~     excluded.~      The quality of care of the units was assessed with the QuIRC filled on line by the managers~     of the units and validated with Service Users Interview Schedule, a face-to-face interview~     with the users (users that could not give informed consent or collaborate in the interview~     were excluded).~   "
91759|NCT02366104|"~     BSHA is a cohort study of healthy elderlies enrolled voluntarily. It has been ongoing since~     December 2008. And the purpose of this study is to assess clinical and biological markers of~     cardiovascular risk in very elderly participants.~   "
91760|NCT02366091|"~     The investigators are studying whether anti-inflammatory agents can improve abnormal coronary~     artery function in patients with coronary artery disease (CAD) and abnormal coronary artery~     endothelial function.~   "
91761|NCT02366078|"~     The purpose of this study is to investigate the outcomes of the Stress Management and~     Resiliency Training (SMART) program among Public School staff in 2 communities in Minnesota.~     Feasibility of a blended in-person and online teaching approach of the program will also be~     evaluated.~   "
91762|NCT02366065|"~     - Lowering intraocular pressure is the only proven treatment for glaucoma. Medications,~     almost always in the form of eye drops, are a mainstay for lowering intraocular pressure. Eye~     drops have the disadvantage of being difficult to administer and can have adverse effects on~     the surface of the eye and the surrounding tissues. Lowering intraocular pressure can be~     accomplished with oral carbonic anhydrase inhibitors, but the many systemic side effects of~     these agents relegates them to drugs of last resort. Therefore, an effective, well-tolerated,~     oral agent would be an important addition to the treatment of glaucoma. The hypothesis is~     that oral acetaminophen can lower intraocular pressure to a clinically significant degree in~     a dosing regimen that is both safe and convenient. The research is important because~     acetaminophen is inexpensive, available over-the-counter, and has a well known safety and~     side effect profile.~   "
91763|NCT02366052|"~     The main aim of the study is to determine if an oral supplementation of the LCS has a~     beneficial effect by itself or even enhances the beneficial effects of a moderate life-style~     intervention on the progression of NAFLD in humans.~   "
91764|NCT02366039|"~     This study is to assess the diagnostic accuracy and precision of the Probe-based Volumetric~     Laser Endomicroscopy (pVLE) imaging system in detecting dysplasia in BE in both in vivo and~     ex vivo imaging of Endoscopic Mucosal Resection (EMR) tissue, as compared to standard~     histopathology~   "
91765|NCT02366026|"~     The primary objective is to compare & evaluate between the treatment groups the changes in~     decline/reduction of HIV viral load changes in the Remune + Amplivax group vs the Amplivax~     placebo groups. Additional objectives include changes in WBC White Blood Cell counts & CD4+ &~     CD8+ T cell counts along with increased HIV immunity.~   "
91769|NCT02365974|"~     Uncontrolled blood pressure represents the main factor in the development of target organ~     lesions and, consequently, cardiovascular events, which are the leading cause of morbidity~     and mortality worldwide. In most cases resistant hypertension is preceded by target organ~     lesions, and is strongly influenced by risk factors or associated diseases. To control this~     disease requires an adequate and intense therapeutic approach that includes lifestyle changes~     and the use of several antihypertensive drugs. However, the results are not always~     satisfactory despite intensive treatment. Of the different pathophysiological mechanisms~     involved in the pathogenesis of resistant hypertension (RH), two, sympathetic overstimulation~     and therapies that block the sympathetic system, have been widely studied. But, these~     approaches are invasive and expensive. Another possible approach is by transcutaneous~     electrical nerve stimulation (TENS), a non-invasive method that modulates activity by~     inhibiting primary afferent pathways using low-frequency transcutaneous electrical~     stimulation. Some studies have shown that TENS reduces blood pressure in patients with~     hypertension. The current study will evaluate the effect of applying TENS in the~     cervicothoracic region of subjects with resistant hypertension, seeking to develop a new low~     cost and readily available therapy to treat this group of hypertensive individuals.~   "
91770|NCT02365961|"~     Patients undergoing a hip scope procedure will be recruited for this study. They will be~     randomized to either receive a nerve block or no nerve block (pain medicine only). Pain~     levels and clinical outcomes will be assessed through 3 months post-operatively.~   "
91771|NCT02365948|"~     This study will characterize the pharmacokinetics (PK) of certolizumab pegol (CZP) and~     evaluate safety of CZP in healthy Chinese subjects. 36 subjects will be randomized to receive~     one of 3 dose levels of CZP or placebo. The total study duration will be approximately 71-94~     days for each subject.~   "
91772|NCT02365935|"~     The investigators primary outcome was to evaluate the effectiveness in term of Overall~     Survival (OS) and disease free interval (DFI) of two different platinum-based chemotherapic~     regimen (3 and 6 cycles) for treatment of Locally Advanced Cervical Cancer (LACC) (IB2-IIB)~     previously treated with Neoadjuvant Chemotherapy Plus Radical Surgery (NACT+RS).~      The secondary outcome was to evaluate and compare safety, in term of toxicity profile, of the~     two treatment options.~   "
91773|NCT02365922|"~     Frontotemporal Lobar Degeneration (FTLD) is the neuropathological term for a collection of~     rare neurodegenerative diseases that correspond to four main overlapping clinical syndromes:~     frontotemporal dementia (FTD), primary progressive aphasia (PPA), corticobasal degeneration~     syndrome (CBS) and progressive supranuclear palsy syndrome (PSPS). The goal of this study is~     to build a FTLD clinical research consortium to support the development of FTLD therapies for~     new clinical trials. The consortium, referred to as Advancing Research and Treatment for~     Frontotemporal Lobar Degeneration (ARTFL), will be headquartered at UCSF and will partner~     with six patient advocacy groups to manage the consortium. Participants will be evaluated at~     14 clinical sites throughout North America and a genetics core will genotype all individuals~     for FTLD associated genes.~   "
91774|NCT02365909|"~     Postdural puncture headaches (PDPH) are a consequence of spinal and epidural anesthesia in~     approximately 1% of cases when performed in obstetric patients. The gold standard treatment~     for a PDPH is currently an epidural blood patch (EBP), which involves placing a needle back~     into the epidural space of the neuraxium and then injecting 20 ml of the patient's own blood~     through the needle and into the epidural space to form a clot over the insult in the tissue~     layer that causes the headaches. The investigators want to test the efficacy of using a less~     invasive procedure, called a sphenopalatine block (SPGB), for treatment of PDPH. SPGB has~     been used for many years in the treatment of migraines and cluster headaches, and there are~     several case reports of its use to successfully treat PDPH as well. SPGB simply involves~     applying a local anesthetic to the mucosa in the back of each nostril to numb the nerves that~     cause the headache. The investigators hope that the SPGB will reduce the number of PDPH~     patients that require and EBP.~   "
91775|NCT02365896|"~     Prospective Randomized Controlled Multicenter Clinical Trial for Comparison of Safety Between~     Totally Laparoscopic Distal Gastrectomy(TLDG) and Laparoscopy-Assisted Distal~     Gastrectomy(LADG) With Billroth-II Reconstruction and D2 Lymphadenectomy for Locally Advanced~     Gastric Cancer~   "
91776|NCT02365883|"~     The purpose of this study is to image human prostate tissue using a new transrectal~     photoacoustic imaging probe and correlate this with ultrasound and MRI imaging performed once~     the specimen has been surgically removed. We hope to see what we can visualize with our~     device as this has never been done before. Eventually, we hope to use a similar device to~     image the prostate in men being seen by their doctor for prostate cancer.~   "
91777|NCT02365870|"~     This study will evaluate the effectiveness of the rotigotine transdermal patch in reducing~     anxiety in people with Parkinson's disease.~   "
91778|NCT02365857|"~     A Randomized, Controlled, Double blind study aiming to evaluate the analgesic potentials and~     side effect profile of different dose levels of Dexmedetomidine added to subarachnoid~     bupivacaine in full-term pregnant women undergoing elective cesarean section using spinal~     anesthesia. The investigators ultimate goal is to find out the least effective dose which~     will be associated with minimal or no side effects. The primary outcome will be the time to~     two sensory block segment regression.~   "
91779|NCT02365844|"~     The purpose of this study is to characterize the blood supply at the base of the tongue and~     within the tonsil region. We hypothesize that high-resolution Narrow Band Imaging (NBI) will~     improve the diagnosis of oropharyngeal carcinoma (OPC). The goal is to provide the better~     assessment of tumor and thus providing better preoperative expectations to patients with OPC~     or tumor extent prior to radiation therapy.~   "
91800|NCT02365571|"~     This study involves single doses of LY3154207 and will evaluate the effects of LY3154207 on~     the body. There will be 3 parts to this study.~      Part A will test single increasing doses of LY3154207 and will last approximately 7 weeks for~     each participant. Each participant will receive two doses of LY3154207, if part A is~     completed.~      Part B will test a single dose of LY3154207 and will last approximately 5 weeks for each~     participant. Part B includes collecting fluid from the spinal column to measure levels of~     LY3154207.~      Part C will include a single dose of LY3154207 given alone and then a second dose given along~     with itraconazole to look for change in LY3154207 levels. Part C will last about 3 weeks for~     each participant.~      Participants may only enroll in 1 of the 3 parts of the study.~   "
91780|NCT02365831|"~     While therapeutic strategies for HER2-positive breast cancer are well defined, there is not a~     standard strategy for HER2-negative tumors.~      Because of lack of information related to the the factors affecting the choice of a~     particular treatment strategy, as well as the optimization of the correct sequence of~     treatments, the choice of the treatment for the advanced disease remains highly empirical and~     may differ significantly among the different cancer centers.~      The purpose of this study is the observation of a cohort of patients with metastatic~     HER2-negative in terms of:~        1. the choice of chemotherapy treatments starting from the first line of treatment;~        2. factors that may influence these choices;~        3. correlation among the characteristics of patients (age, menopausal status, etc.) and~          type of adjuvant and metastatic treatment ;~        4. clinical outcome (pattern of relapse, time from diagnosis, etc.);~        5. evaluation of the adherence to the literature's recommendations for therapeutic~          sequences in clinical practice.~   "
91781|NCT02365818|"~     To study the safety and efficacy of CG0070, an oncolytic virus expression GMCSF in high grade~     non muscle invasive bladder cancer patients who failed BCG therapy and refused cystectomy.~   "
91782|NCT02365805|"~     Neoadjuvant chemotherapy (NAC) is increasingly used for early-stage operable breast cancer.~     Response of breast cancer to NAC is correlated with survival: patients who obtain greatest~     survival advantage are those who attain complete response of their primary tumor. BReast~     Cancer 1 (BRCA1) plays a crucial role in DNA repair and associations between BRCA1 mRNA~     expression and sensitivity to platinum and/or resistance to taxanes has been previously~     documented. We propose a two-arm, randomized, multi-centre, open-label phase II study to~     compare the efficacy and tolerability of NAC customized by BRCA 1 levels versus standard FEC~     chemotherapy, being pathological complete response the primary endpoint.~   "
91783|NCT02365792|"~     The ProDEms-trial focuses on nurses and ambulance drivers working in prehospital care, taking~     care on the one hand of patients suffering from time-sensitive critical conditions like~     STEMI, acute stroke or severe traumatic brain injury, and on the other hand of patients whose~     lives are not in immediate danger but suffer from acute exacerbation of chronic conditions or~     suffer from acute pain.~      In the current study the investigators will use a multistage approach to test the hypothesis~     whether the use of a CDSS in prehospital emergency care will: 1. Improve protocol adherence,~     2. Reduce emergency department length of stay, 3. Improves diagnostic accuracy; without~     impeding the workflow of the prehospital team or impairing patient safety.~   "
91784|NCT02365779|"~     High-grade serous ovarian cancer is the most threatening type of gynaecological cancer with~     an important mortality due to late diagnosis. However the prognosis is excellent in the early~     stages of the disease. Recently it has been described a new serous carcinogenic sequence from~     the fallopian tube with tubal precancerous lesions. Therefore the identification of these~     early preinvasive lesions would be of great interest in the population with hereditary~     predisposition for ovarian cancer (concept of oncofertility) and in the general population~     (to determine whether bilateral salpingectomy has to be performed during a hysterectomy for~     benign disease).~      The optical biopsy has been developed and validated in the detection of early precancerous~     lesions (such as Barrett's oesophagus or in situ cancer of the bladder). The first objective~     of this study is to prospectively assess the efficacy of optical biopsy (Cellvizio®) in the~     study of fallopian tubes during laparoscopy with correlation between the histopathological~     and immunohistochemical analysis and the endomicroscopy image interpretation. The second~     objective is to describe the optical biopsy pictures in order to state a classification.~   "
91785|NCT02365766|"~     This is a pre-surgical study involving subjects with muscle invasive bladder cancer, or~     urothelial cancer, who are candidates for neoadjuvant therapy. It is is a two-part trial with~     a one-arm phase Ib portion followed by a two-arm phase II portion. The study treatment is~     stratified into two cohorts based on cisplatin eligibility.~   "
91786|NCT02365753|"~     A double-blinded randomized control study using a pulsed electromagnetic field therapy to~     establish whether this device decreases patient pain and decreases narcotic use in women who~     have undergone cesarean delivery.~   "
91787|NCT02365740|"~     This study evaluates the prevalence of gastric emptying (GE) in type 1 diabetic patients~     (DM1) free of chronic complications in comparison with a group of healthy control subjects.~     The investigators will also assess the relationship between GE and glucose control (HbA1c,~     postprandial glucose variability), gut peptide hormones (GLP-1, GIP, and ghrelin), and~     gastrointestinal symptoms.~      In addition, in patients with delayed GE the investigators will investigate the effect of~     tailored pre-prandial insulin bolus administered by means of insulin pump in reducing~     postprandial glucose variability, evaluated through continuous glucose monitoring system.~   "
91788|NCT02365727|"~     Patients will be randomized (like the flip of a coin) to receive Exparel and a nerve block,~     standard of care for this procedure, or Exparel alone for pain management after surgery. They~     will also be asked to complete questionnaires before surgery, during their stay at the~     hospital after surgery, then at 3 months, 6 months and 12 months after surgery to assess pain~     and/or function levels, as well as the amount of pain medicine patients have used after~     surgery. Patients' leg strength will be measured immediately after surgery and again at 3, 6~     and 12 months after surgery.~   "
91789|NCT02365714|"~     This study will prospectively evaluate the technical feasibility, acute toxicity, late~     effects and oncologic outcomes of CyberKnife Stereotactic Accelerated Partial Breast~     Irradiation (CK-SAPBI) in early stage breast cancer. It will evaluate quality of life (QOL)~     issues as they relate to treatment-related side effects and cosmetic results.~   "
91790|NCT02365701|"~     This study is to evaluate efficacy of the investigational drug Motilitone at 90 mg in~     patients with Functional Dyspepsia as measured by change in maximum tolerated volume and~     aggregate symptom score on the nutrient drink test.~   "
91791|NCT02365688|"~     The purpose of this study is to retrospectively evaluate the hemodynamic response to goal~     directed fluid therapy fluid during open abdominal surgery where goal directed fluid therapy~     is a standard of care after establishing a pre-incision baseline response to fluids.~   "
91792|NCT02365675|"~     The purpose of this study is to compare the efficacy of four dressings (covers) namely: gauze~     with petrolatum , cellulose acetate with petrolatum , pure carboxymethylcellulose with silver~     and nanocrystalline silver to improve the new growth of skin, reduce pain and itch in persons~     suffering from pemphigus and pemphigoid.~   "
91801|NCT02365558|"~     The purpose of this study is to evaluate the effect of increased stomach pH on how much~     evacetrapib is found in the blood stream and how long the body takes to get rid of it when~     given to healthy participants. Information about any side effects that may occur will also be~     collected.~      There are two parts to the study. Participation in both parts will be required.~      The study will last approximately 30 days, not including screening.~   "
91802|NCT02365532|"~     This study will evaluate the effect of oral GS-6615 on QTc interval in healthy adults with~     dofetilide-induced QTc prolongation.~   "
91803|NCT02365519|"~     The purpose of this study is to evaluate the efficacy of LME636 compared to vehicle in the~     reduction of ocular symptoms and to evaluate the safety and tolerability of LME636, when~     administered topically for up to 42 days, in subjects with severe dry eye disease.~   "
91804|NCT02365506|"~     This study will evaluate the effect of oral eleclazine (GS-6615) on QTc interval, safety, and~     tolerability in adults with long QT2 syndrome.~   "
91805|NCT02365493|"~     The aim of this clinical trial is to determine whether a novel combination antibiotic~     treatment (vancomycin/daptomycin + beta-lactam) is superior to the standard antibiotic~     treatment (vancomycin/daptomycin) for hospitalised adults with Methicillin Resistant~     Staphylococcus aureus bacteraemia. The hypothesis is that the addition of beta-lactam~     antibiotics (these are antibiotics from the penicillin family) to the standard therapy will~     lead to more efficient bacterial killing and hence lead to faster clearance of bacteria from~     the blood stream and other areas of infection, thereby reducing the risk of the spread of~     infection and death.~      The study design is an investigator-initiated, multi-centre, open-label, randomised~     controlled trial. This will include 440 participants diagnosed with Methicillin Resistant~     Staphylococcus aureus bacteraemia recruited over a period of 4 years (July 2015 - June 2019)~     from within Infectious Diseases inpatient units across 21 hospital sites including 18 from~     within Australia and 3 located in Singapore. Participation will be voluntary and subject to~     informed consent. The participants will be randomised 1:1 to either the standard therapy~     group or combination therapy group. The combination therapy will include a treatment of~     intravenous beta-lactam for the first 7 days of treatment, in addition to the standard~     treatment (either vancomycin or daptomycin). The primary outcome measure will be~     complication-free survival 90 days post randomisation.~   "
91806|NCT02365480|"~     This randomized, pilot phase I trial studies the side effects of berberine chloride in~     treating patients with ulcerative colitis and who are in remission (a decrease in or~     disappearance of signs and symptoms of cancer) to reduce the risk of colorectal cancer.~     Patients with ulcerative colitis are at increased risk for colorectal cancer. Chemoprevention~     is the use of drugs, such as berberine chloride, to keep a disease/condition from forming or~     coming back. The use of berberine chloride may keep colorectal cancer from forming in~     patients with ulcerative colitis.~   "
91807|NCT02365467|"~     The purpose of the Feasibility study is to characterize the safety of the Valiant Mona LSA~     Thoracic Stent Graft System, including an assessment of the safety and effectiveness of the~     device acutely and at the 30 day visit in the identified subject population. This study will~     also evaluate the current instructions for use and may direct changes to the delivery and~     deployment steps.~      The purpose of the expansion to the Feasibility Study is to characterize the Valiant Mona LSA~     Thoracic Stent Graft System, in particular to assess the safety and effectiveness of the~     device acutely and at the 30 day visit, in subjects enrolled with chronic, Type B~     dissections.~   "
91808|NCT02365454|"~     A multicenter, prospective, open-label, non-randomized, interventional clinical study,~     sponsored by Endospan Ltd. Patients will be followed-up for five years.~   "
91809|NCT02365441|"~     An open label randomised trial for adults with histologically confirmed measurable metastatic~     GIST who have received no other treatment for metastatic disease. The study aims to determine~     if an alternating regimen of imatinib and regorafenib has sufficient activity and safety in~     comparison to imatinib alone to warrant further evaluation as a first line treatment for~     metastatic GIST.~   "
91810|NCT02365428|"~     Fewer pregnant women achieve recommendations for physical activity (PA) (30 minutes of~     moderate PA 5 days of the week) as compared to non-pregnant women (15.8% to 26.1%~     respectively), and PA participation declines as pregnancy progresses. The benefits of PA~     during pregnancy are abundant to both the mother (e.g., reduced weight gain, lower risk of~     gestational diabetes) and the fetus (e.g., decreased fat mass, improved stress tolerance).~     Pregnancy represents a significant time in a woman's life in which she may be motivated to~     change her health behaviors due to concerns for the healthy development of the fetus and a~     quick return to pre-pregnancy weight. Hence, pregnancy represents a critical time to support~     women in PA participation.~      In our previous research, 94% of pregnant and postpartum women of varying socioeconomic~     statuses reported using the Internet for pregnancy and PA information. Despite some women~     increasing their PA participation as a result, most did not know if a website was reputable~     or reliable (i.e. evidence-based). Studies have reported that most online health information~     is unregulated and inaccurate. Further, women often receive inadequate PA information from~     physicians who are constrained by time and lack of knowledge about PA. Therefore, directing~     pregnant women to evidence-based websites via text messaging may provide a feasible approach~     to improve PA participation. PA participation in pregnant women is an ongoing challenge that~     warrants testing of innovative solutions.~      The purpose of this study is to determine the feasibility of using mobile phone text~     messaging to refer pregnant women to evidence-based websites for PA information to increase~     PA levels.~   "
91825|NCT02365233|"~     The primary objective of this trial is to measure changes in hepatic lipid content using~     three common alternative therapeutic strategies to improve glycemic control in patients with~     type 2 diabetes who are not controlled with metformin alone.~   "
91826|NCT02365220|"~     The purpose of this study is to investigate the placebo effect in a smartphone-based~     training, ostensibly designed to improve mood and perceived stress by daily exposition to~     either mock sound or color.~   "
91827|NCT02365207|"~     Patients with invasive bladder cancer will be given 3-6 treatments (based on treatment~     response) BCG intravesically followed by a cystectomy.~   "
91828|NCT02365194|"~     A pre-operative physical conditioning and weight loss intervention (prehabilitation) compared~     to standard counseling prior to ventral hernia repair for obese patients (BMI 30-40 kg/m2) at~     a safety-net hospital results in a higher proportion of patients being hernia- and~     complication-free 2 years after surgical consultation.~   "
91811|NCT02365415|"~     This is a research study to assess whether an oral medication can benefit some patients being~     treated for peripheral pulmonary stenosis (PPS), which is narrowing of the blood vessels that~     send blood to the lungs (pulmonary arteries).~      In the cardiac catheterization laboratory, the investigators treat PPS by dilating the~     narrowed segments of pulmonary arteries using balloon catheters. Sometimes the investigators~     also place stents which are mesh tubes that help keep the narrowed vessel open. Some stents~     suffer from in-growth of tissue into the stents which causes recurrent obstructions inside~     the stent (i.e. making the opening inside the mesh tube narrow again), so called in-stent~     stenosis (ISS).~      The purpose of this study is to use a medication that is approved for use in children (for a~     different purpose) to decrease the amount of cell ingrowth inside the stents (i.e. decrease~     the problematic in-stent stenosis). The medication is called rapamycin, also known as~     sirolimus (trade name Rapamune). It has antiproliferative properties which means that it~     slows down cell division which the investigators believe cause the recurrent narrowing inside~     stents.~      Rapamycin is a medicine that can be taken by mouth as a liquid or pill or via a feeding tube.~     There will still be a need for interventions in the catheterization laboratory but the~     investigators hope that by taking this medicine some children would need fewer~     catheterizations in the future. Our early experiences with a few patients who have been~     treated with rapamycin due to in-stent stenosis in the pulmonary arteries suggest that it may~     be helpful.~      In this study, patients and families who are interested in possibly trying this new approach~     will be randomized to sirolimus or no sirolimus. The investigators will compare the~     developement of ISS over time between these groups, in a hope to learn whether oral sirolimus~     reduces ISS development.~   "
91812|NCT02365402|"~     The aim of interferon therapy in HBeAg negative chronic hepatitis B was to make patients~     obtain immune control to hepatitis B virus defined as sustained viral response after~     treatment. However this target could not be get if patients keep HBV DNA positive during~     interferon treatment and offend relapse after treatment withdraw. In this trail, entecavir~     will add on patients with HBV DNA load ≥1000copies/ml after 3 months of peginterferon alpha~     2a treatment, and the efficacies of the combine treatment will be evaluated by the rate of~     sustained viral response after 48 weeks of treatment and 24 week follow up.~   "
91813|NCT02365389|"~     A previous study showed that in situ MTZ vaginal gel twice daily is more effective than the~     conventional vaginal gel product in sustained cure of BV( 4 weeks after treatment) (80.0% in~     the in-situ gel group as compared with 47.4 in the conventional gel group.The current study~     aims to compare the efficacy of the use of once daily in situ MTZ vaginal gel (0.8%) versus~     twice-daily conventional MTZ vaginal gel in treatment of BV.~   "
91814|NCT02365376|"~     The objective of this protocol is to enable collection of biospecimens to facilitate current~     and future multidisciplinary research in rare genetic disorders and medical conditions.~   "
91815|NCT02365363|"~     The objectives are to test the acute effects of different bagels containing pulse ingredients~     on: 1) aerobic endurance and substrate oxidation during exercise 2) response of blood~     glucose, insulin and appetite to an aerobic exercise session, and 3) food intake two hours~     following the exercise session. We hypothesize that consumption of bagels containing pulse~     ingredients 60 minutes before exercise will increase aerobic endurance (lower oxygen~     consumption), decrease carbohydrate oxidation (greater respiratory quotient), and a reduction~     in lactate production during compared to the same exercise session following the ingestion of~     a non-pulse food. We also hypothesize that consumption of bagels containing pulse ingredients~     will lead to lower blood glucose, insulin, appetite and food intake, suggesting lower calorie~     compensation, following a 60-minute aerobic exercise session compared to the same exercise~     session following the ingestion of a non-pulse food.~   "
91816|NCT02365350|"~     The primary objective is to demonstrate superiority of follicle flushing with the STEINER-TAN~     Needle® as compared to single lumen aspiration in terms of numbers of COCs retrieved.~   "
91817|NCT02365337|"~     The aim of this study is observing the relation between serum Vitamin D levels and~     morphokinesis of time lapse monitored Day 5 embryo in between 18 and 38 years age women~     undergoing controlled ovarian hyperstimulation (COH) because of unexplained or tubal factor~     infertility. Individuals will be divided into 2 groups according to serum vitamin D levels as~     normal or low , and the influence of those levels in morphokinetic parameters of embryos will~     be identified.~   "
91818|NCT02365324|"~     The proposed integrated project will evaluate the effects of an evidence-based extension~     education program, Family Fitness Program (FFP) grounded in Stages of Change Learning Theory~     and guided by Social Cognitive Theory (SCT), with and without a peer-education mode of~     delivery on balancing calories to manage body weight (BW), reducing certain foods and food~     components, increasing selected foods and nutrients, building healthy eating patterns [i.e.,~     fundamental principles of the Dietary Guidelines for Americans (DGAs), 2010] and SCT~     variables. Briefly, the 12-week program will target early adolescent children, ages 11-14~     years, test a peer-education approach to behavioral change and will be delivered as an~     after-school program in local middle schools in support of childhood obesity prevention. Data~     will be collected at baseline (preintervention), after the 12-week program~     (post-intervention) and 6 months after completion of the program (maintenance).~   "
91819|NCT02365311|"~     The investigators used transesophageal echocardiography (TEE) to assess the change of~     pulmonary blood flow and bi-ventricular function during lung isolation. The investigators~     hypothesized that changes in pulmonary venous flow with lung isolation may be related the~     shunt fraction and oxygenation during one lung ventilation (OLV). The investigators also~     observed the cardiac function during two lung ventilation (TLV) and OLV in supine and lateral~     position by TEE.~   "
91820|NCT02365298|"~     In vitro studies show that some hydrogel materials uptake more lysozyme than other hydrogel~     materials and that this protein remains largely active and promotes reduced cytokine response~     in an in vitro culture of human corneal epithelial cells. This study investigates whether~     these data transfer to the in vivo situation.~   "
91821|NCT02365285|"~     The investigators will test the hypothesis that acute central acetylcholinesterase inhibition~     will restore PNS activity and reduce oxidation in AAW compared to whites.~   "
91822|NCT02365272|"~     The aim of the study is the evaluation of PK/PD target attainment of amikacin in ED patients~     with severe sepsis and septic shock.~   "
91823|NCT02365259|"~     The current study examines the effect of phototherapy equipped with Narrow Band UVB lamps on~     vitamin D production in persons with MS.~   "
91824|NCT02365246|"~     Removal of IgE through adsorption of IgE on a specially designed column after apheresis of~     blood has the potential to improve the severity of atopic dermatitis.~      In this study the investigators will treat patients with a severe form of Atopic dermatitis~     not responding or having to much side effects to systemic imunosuppressive treatment with~     this modality.~   "
91829|NCT02365181|"~     The control of perioperative pain is necessary to avoid worst surgical suites after shoulder~     arthroplasty. Interscalene block (ISB) with or without catheter is the gold standard in~     postoperative analgesia after shoulder prosthesis but neurological or respiratory adverse~     events can occured . The intra-articular local (IAL) anesthetic infiltration with catheter is~     a simple procedure. Its efficacy was proved in knee and hip arthroplasty but not in shoulder~     arthroplasty. Our hypothesis was the IAL is as effective as ISB in early postoperative~     analgesia after shoulder arthroplasty.~   "
91830|NCT02365168|"~     Study hypothesis:~      Some children and adolescents with fish allergy can tolerate eating some species of fish~      Purpose of the study:~      The purpose of this study is to determine to which degree fish allergic children and~     adolescents can tolerate some species of fish and find the minimal eliciting allergen dose to~     which only 10% of participants get allergic reaction.~      Participants:~      Participants are 40 patients recruited from children and adolescents outpatient clinics at~     the University Hospital of North Norway with a history of fish allergy and sensibilisation of~     one or more fish species with either positive specific IgE in serum or skin prick test.~     Patients with sensibilisation to one or more fish species that never have eaten fish are also~     recruited.~      Method:~        -  All participants undergo a clinical examination including lung function test with~          spirometry before inclusion in the study.~        -  All participants are tested for allergic sensibilisation with measure of specific IgE~          against common food and inhalation allergens in addition to 10 different fish species.~        -  All participants are challenged with cod, salmon, mackerel and placebo, disguised in a~          chocolate mousse. The challenges are performed in randomized order with Double Blind~          Placebo Controlled Food Challenge (DBPCFC) on 4 different challenge days with minimum 6~          weeks in between each challenge day.~        -  Participant with allergy to pollen will not be challenged during pollen season.~        -  Test food is developed especially to this study in cooperation with The National~          Institute of Food Research in Norway and The University of Manchester. The National~          Institute of Food Research in Norway have produced a dried powder of cod, salmon and~          mackerel. The Molecular Allergology group at Manchester Institute of Biotechnology, the~          University of Manchester, have produced test kits based on chocolate mousse containing~          low and high doses of the fish powders. The National Institute of Food Research have~          measured protein content and microbiology in the fish powders. The Molecular Allergology~          group have provided quality measurements of the final product and tested the disguise in~          a sensoric test panel.~        -  Participants with no allergic reaction to one or more of the blinded challenges undergo~          open food challenge with larger doses of cooked fish than used in the DBPCFC, after the~          randomization has been broken.~   "
91831|NCT02365155|"~     There is enough scientific evidence of the benefits detection of frailty in patients with~     heart failure, which is an important prognostic factor. The usefulness of screening frailty~     as flattering tool making diagnostic and therapeutic decisions in patients with heart failure~     and now emerges in various recent studies. However, it is not found in the literature any~     study on the potential effectiveness of a comprehensive intervention on the fragility that~     includes the physical section (endurance, strength, flexibility and balance), nutritional,~     hormonal (supplementation deficit D vitamin) and pharmacological (adjusted to clinical~     guidelines according to requirements) in patients with heart failure after hospitalization~     for cardiac decompensation, to improve survival and reduce cardiac decompensation and~     hospital admissions resulting in a better quality of life for these patients. Therefore, the~     investigators designed the following study.~   "
91832|NCT02365142|"~     Purpose: To determine the safety, feasibility and effectiveness (clinical and radiological)~     of intra-articular administration of autologous mesenchymal stem cells (MSCs) with platelet~     richa plasma (PRGF) in patients with knee osteoarthritis.~      Patients and methods~      Clinical trial phase I- II, randomized , multicenter , with two treatment arms and 19~     patients for each group. The investigators compare the intraarticular injection of against~     the administration of two different doses of mesenchymal stem cells with hialuronic acid~     according to the following scheme:~        1. Group A: 3 intra-articular injections of platelet rich plasma (PRGF®) separated by 7~          days.~        2. Group B: 3 intra-articular injections of platelet richa plasma (PRGF®) separated by 7~          days and one with Mesenchimal stems cells. Intra-articular injection of 100 million~          autologous mesenchymal progenitor stem cells cultured ex - vivo (cell suspension sterile~          small volume (5-10 ml ) in a vehicle suitable for intraarticular injection ) followed by~          an intraarticular injection of platelet richa plasma (PRGF®). The treatment is completed~          with 2 more injection of platelet richa plasma (PRGF®) separeted by one week.~      In addition the investigators assess the response to intra-articular infusion of CMM~     analyzing the following parameters:~        -  Clinical assessment of pain and function (Baseline, 1, 3, 6 and 12 months since~          treatment): VAS , WOMAC , KOOS , EuroQol, SF-16, Lequesne , WOMAC , KOOS.~        -  Radiographic (baseline and 12 months from treatment): Femorotibial space.~        -  Radiographic using MRI (baseline and 12 months from treatment): by assessing the number~          location of the lesions , cartilage thickness , signal intensity , subchondral bone~          alteration , volume and WORMS and dGEMRIC protocols.~   "
91833|NCT02365129|"~     The energy burning capacity of brown adipose tissue makes it an attractive target for~     anti-obesity therapies. Sympathetic nervous system (SNS) is the classical regulator of brown~     adipose tissue; however, recent findings show a pool of novel brown adipose tissue activators~     that sidestep the need for stimulating the SNS, including cardiac natriuretic peptides. Of~     interest is that both SNS and non-SNS brown adipose tissue activators are sensitive to~     physical exercise, which opens new horizons and opportunities to study the potential effect~     of exercise-based therapeutic interventions. Moreover, a new protein released by~     exercise-stimulated skeletal muscle, irisin, seems to play a key role in the browning program~     of white adipose tissue. Most of the available evidence comes from animal studies, which is~     sometimes difficult to infer to human physiology. The overall objective of the ACTIBATE~     randomized controlled trial is to study the effect of long-term exercise training (6 months)~     on brown adipose tissue activity and quantity (primary outcomes) in young overweight and~     obese adults. The clinical significance of activating and recruiting brown adipose tissue on~     resting metabolic rate and cardiometabolic profile in humans will be determined. The~     investigators will also study at the molecular level the benefits of exercise on the~     regulation pathways in two different tissues: white adipose tissue and skeletal muscle, as~     well as identifying possible cross-talk between the exercising muscle and heart, and fat.~     Information from exercise-induced signaling on brown adipose tissue, white adipose tissue and~     skeletal muscle will help on identifying potential molecular therapeutic candidates.~   "
91860|NCT02364778|"~     This is a prospective study to analyze the outcome of provisional main vessel stenting on~     side branch by utilizing Two-Dimensional (2D) and Three-Dimensional (3D) frequency domain~     optical coherence tomography (FD-OCT). To analyze the fate of side-branch after provisional~     main vessel stenting based on morphology defined prior to PCI by OCT. Offline analysis of~     side branch impingement of the ostium of SB leading to acute loss in SB diameter area, carina~     shift and plaque shift will be also be performed.~   "
91861|NCT02364765|"~     The purpose of the present study was to compare some hematologic parameters and operation~     time in patients who underwent esthetic bimaxillary surgery under hypotensive anesthesia.~   "
91834|NCT02365116|"~     Every year in the United States about 1 million people make a suicide attempt and more than~     38,000 die by suicide. The risk of suicide is highest among individuals with mental illness~     who have been hospitalized due to suicidal thoughts or behaviors, yet there are few~     interventions known to reduce suicide risk in this population. This study will develop and~     pilot test a peer mentorship intervention by which trained peer professionals will use their~     own personal experience with recovery from mental illness to instill hope and belongingness~     in high-risk patients and provide additional support to prevent future suicidal thoughts or~     behaviors.~      The specific aims of the study are to: (1) develop a peer mentorship intervention to reduce~     suicide risk among patients psychiatrically hospitalized with suicidal ideation or following~     a suicide attempt; (2) Conduct a randomized controlled pilot study to assess the~     acceptability, feasibility, and fidelity of the peer mentorship intervention in preparation~     for a larger efficacy trial; and (3) an exploratory aim will be to measure potential~     mediators and moderators of intervention effectiveness in terms of belongingness,~     burdensomeness, and hopelessness according to the interpersonal theory of suicide.~   "
91835|NCT02365103|"~     The purpose of this study is to investigate the inhibition effect of tea consumption on non~     haem iron absorption with the use of an iron tracer. The study also aims to assess the effect~     of time variability of tea consumption on non haem iron absorption from a typical western~     breakfast.~   "
91836|NCT02365090|"~     1. To determine whether a binocular iPad game app is effective in improving visual acuity~          and reducing interocular suppression in amblyopic children~        2. To compare the amount of visual acuity improvement achieved with the binocular game app~          to the amount achieved with patching (standard treatment for amblyopia)~   "
91837|NCT02365077|"~     This is a observation clinical trial. We are collecting the patients with glucocorticoid.~     They were divided into the experiment group (with femur head necrosis) and control group~     (without femur head necrosis).Then, we will analyse the patients' genome with genome-wide~     association study (GWAS). Our purpose is to find susceptibility loci for~     glucocorticoid-induced femur head necrosis in the Chinese population.~   "
91838|NCT02365064|"~     The study will determine which of two different types of positive airway pressure (PAP~     therapy) modes are more effective in reducing sleep breathing events in chronic insomnia~     patients and in decreasing insomnia severity.~   "
91839|NCT02365051|"~     This community-based translational trial tests the value of a proven non-pharmacologic~     intervention for older adults living with dementia and informal caregivers when this~     intervention is incorporated into a publicly-funded home and community based service program.~     Half the participants will receive customary publicly-funded services alone, and half will~     receive customary services plus the proven non-pharmacologic intervention.~   "
91840|NCT02365038|"~     This is a multicenter randomized controlled pilot trial to investigate the feasibility of a~     driving pressure limited mechanical ventilation strategy compared to the ARDS Clinical~     Network strategy (conventional strategy) in patients with acute respiratory distress syndrome~     (ARDS).~   "
91841|NCT02365025|"~     Amongst adolescents, there is a gap that widens with age between recommended sleep duration~     and actual sleep time. Due to this gap, bodily and mental functions such as those related to~     the metabolic and immune systems, performance, memory, school achievement and creative~     ability can be harmed. Moreover, lack of sleep involves an increased risk of accidents and~     injuries, behavior problems and reduced quality of life.~      Biological factors that explain changes in sleep patterns include delays in the circadian~     timing system and in the homeostatic system that regulate sleep and wakefulness. These~     changes cause a growing and continuous delay in sleep phase during adolescence. In addition,~     a number of environmental factors affect sleep patterns: variables such as early school start~     time, increased homework assignments, after-school activities, lack of parental demand for~     adequate sleep hours, and increased screen time, or use of electronic media, including~     television, computer games, internet and cellular phones.~      Based on the Parental Style model, the authoritative parenting style is characterized by~     parents setting high demands on their children on the one hand and displaying high levels of~     responsiveness to their children on the other. The authoritarian parenting style is~     characterized by parents setting high demands on their children on the one hand yet~     displaying low levels of responsiveness to their children on the other. The permissive~     parenting style is characterized by parents setting low demands on their children and~     displaying high levels of responsiveness to their children. In several investigations, the~     authoritative parenting style has been shown to have a positive influence on child~     development, academic achievement and psychosocial competency, and promoted healthy behaviors~     in adolescents, such as good eating habits, increased physical activity and a decrease in~     risky behaviors such as smoking, alcohol abuse, extreme diets and early sexual behavior.~      The Conceptual Model views parents as the sole agents of change in their children's life, and~     focuses on the power of personal example, environmental changes and promotion of the~     authoritative parental style. The main aim of this research is to evaluate the effectiveness~     of an intervention program that deals with increasing parents' awareness of the changes that~     characterize adolescents and encourages the authoritative parental style based on the~     Parenting Style Model.~   "
91842|NCT02365012|"~     This study will evaluate whether treatment with the α1-agonist, midodrine, reduces subjective~     orthostatic lightheadedness as measured by the Non-Motor Symptoms Scale for Parkinson's~     Disease (NMSS) questionnaire, in patients with (positive control group, OH) or without~     documented orthostatic hypotension(orthostatic intolerance, OI). It will also demonstrate the~     effect of treatment with an α1-agonist, midodrine, on beat-to-beat blood pressure and heart~     rate response during Valsalva maneuver (measured by Continuous Non-invasive Arterial~     Pressure, CNAP) in patients with OI or OH and evaluate the relationship to symptom~     improvement.~   "
91843|NCT02364999|"~     This is a multinational, double-blind, randomized, parallel-group Phase 3 clinical trial~     evaluating the efficacy and safety of bevacizumab-Pfizer plus paclitaxel and carboplatin~     versus bevacizumab-EU plus paclitaxel and carboplatin in first-line treatment for patients~     with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous NSCLC.~   "
91857|NCT02364817|"~     Some recent studies have found that adult attention deficit - hyperactivity disorder (ADHD)~     was frequent among patients with alcohol-dependence. However, no investigation has ever~     addressed whether ADHD may impact the drinking outcome.~      Moreover, most of the different aforementioned studies assessed ADHD using the ADHD~     self-report scale (ASRS). The ASRS is a screening questionnaire that is of limited diagnostic~     value, and the overrepresentation of high-score ASRS among patients with alcohol-dependence~     could be in part due to differential diagnoses such as antisocial or borderline personality~     disorders, executive function impairments, or isolated impulsiveness.~      The study aims to evaluate ADHD: Gaps between patients with Alcohol Dependence and Impact on~     early Relapse (AGADIR). In AGADIR, subjects with alcohol-dependence are recruited at the end~     of a residential detoxification program. They are assessed for ADHD using the ASRS, but also~     with a standardized diagnostic tool, i.e., the Diagnostic Interview for ADHD in adults (DIVA~     2.0). Potential differential diagnoses are screened during the baseline visit. The patients~     are followed-up during the 12 first post-detox weeks, through a standardized psychosocial~     treatment. ASRS is re-performed at the end of the follow-up.~   "
91844|NCT02364986|"~     There are two standard and a few second line treatments for RRMS. Since the disease cannot be~     cured by these existing treatments and all treatment options have significant limitations,~     there is the need to develop new treatment strategies to improve therapy of patients with~     RRMS. We developed a RIG-I ligand as a new therapeutic strategy for patients with MS. The~     RIG-I ligand functions partially via induction of Interferon beta (IFN-b), but has advantages~     over therapy with recombinant IFN-b. Identification of suitable biomarkers to monitor~     treatment with RIG-I ligand and to guide the dose steps would help to increase the safety of~     the volunteers in the early clinical trials with RIG-I ligand.~      The RESI study is designed to analyse immune readouts and potential biomarkers such as type I~     IFN levels, type I IFN dependent immune activation and miRNA expression following Rebif or~     Avonex (Interferon beta 1a) application. Rebif is applied s.c. at a dose of 44 µg three times~     a week (on day 1,3,5 and 8), and Avonex i.m. at a dose of 30µg once a week (on day 1 and 8),~     as they are routinely used in RRMS-therapy. The immune readouts are assessed on day 1, 3, 5~     and 8 immediately before application of Rebif/Avonex and on day 1 and 8 at 1 / 6 / 12 /24 hrs~     after Rebif/Avonex application by analysing blood samples. Since studies of the RIG-I ligand~     will start in healthy volunteers and will be continued in MS patients we need data from both~     populations since they could show significant differences in response to IFN-b. Thus, the~     RESI study includes healthy volunteers, RRMS-patients already under Rebif/Avonex treatment,~     and RRMS-patients who have to yet started a therapy with Rebif/Avonex.~   "
91845|NCT02364973|"~     The main purpose of the present study is to examine the diagnostic performance of combined~     PET-MRI in detecting colonic and small bowel wall inflammatory processes caused by ulcerative~     colitis and Crohn's disease.~   "
91846|NCT02364960|"~     The purpose of this study is to create a registry to evaluate the use of intra-operative~     radiation therapy (IORT) and to study the efficacy and toxicity of breast radiotherapy given~     intra-operatively as a single fraction after breast conserving surgery,~   "
91847|NCT02364947|"~     The efficacy, safety, and dose-response of nalmefene hydrochloride at 10 mg and 20 mg in~     patients with alcohol dependence will be evaluated in a multicenter, randomized,~     double-blind, placebo-controlled, 3-parallel-group comparative trial. The superiority of~     nalmefene hydrochloride at 20 mg to placebo will be verified in terms of reduction of alcohol~     consumption.~   "
91848|NCT02364934|"~     To explore and compare the effects of propoful, sevoflurane, and a combination of both on the~     pharmacokinetics and pharmacodynamics of rocuronium.~      To discover and confirm sex differences on the pharmacokinetics and pharmacodynamics of~     rocuronium.~      To evaluate and examine aged people on the pharmacokinetics and pharmacodynamics of~     rocuronium.~   "
91849|NCT02364921|"~     The purpose of this study is to evaluate the effectiveness of a multilayer compression~     bandage (two layers), compared with the crepe bandage, on healing of venous leg ulcers, in~     patients attended in nursing Primary Care Health Centres, at 12 weeks follow-up.~   "
91850|NCT02364908|"~     This study is a biomedical, open label, therapeutic strategy, interventional, non-randomized,~     multicenter study to evaluate the non compliance to antimalarials in patients with systemic~     lupus in the Nord Pas-de-Calais region (FRANCE). It is conducted in two visits. These visits~     consist in obtaining blood sample, performing a clinical examination and filling in a~     questionnaire (Quality Of Life, Coping...).~      The goal for the noncompliants patients is to guide them towards the therapeutic education~     with professionals (nurses and physicians).~   "
91851|NCT02364895|"~     This study evaluates effectiveness of mailed invitations for colorectal cancer screening~     among screen-eligible Ontarians who are due for screening. The study will evaluate the~     effectiveness of mailed invitations in general (compared to no invitation) but will also~     determine if new invitation letters (2 letters for male, 1 letter for females) are more~     effective than current invitation letters used by the ColonCancerCheck program.~   "
91852|NCT02364882|"~     This is a Phase 1, single center, open-label, within-subject dose-escalation study evaluating~     the safety and pharmacokinetics of SST-6006 in healthy postmenopausal women. Three dose~     levels of SST-6006 and a placebo regimen will be evaluated: 1 g (0 mg of sildenafil), 1 g (50~     mg of sildenafil), 2 g (100 mg of sildenafil), and 4 g (200 mg of sildenafil). Doses will be~     administered sequentially and will be separated by a 14-16 day washout period. All 3 dose~     levels and the placebo will be applied both externally and internally.~   "
91853|NCT02364869|"~     This 12-week double-blind randomized controlled clinical trial aims to investigate the effect~     of a prebiotic (fructooligosaccharide - FOS) on serum and urinary levels of uremic toxins~     (p-cresyl sulfate and indoxyl sulfate) of non-dialysis dependent CKD patients, and the impact~     of such intervention on cardiovascular markers, intestinal permeability, endotoxemia and~     inflammatory response.~   "
91854|NCT02364856|"~     This study evaluates Analgesia Nociception Index (Heart Rate Variability based index) and its~     variations after painful stimulations in children with cerebral palsy : acute procedural pain~     (botulinum toxin injections), and recurrent pain (physiotherapy).~   "
91855|NCT02364843|"~     This is the 5th in a series of physiological studies to determine the amino acid requirements~     of infants. There have been 4 studies to determine tyrosine, methionine, threonine and lysine~     requirements in infants when they are fed by parenterally (intravenously). Due to the new~     requirements of Health Canada for preparation of parenteral solutions, the investigators are~     starting the phase of the study that determines the enteral (oral) intake of threonine in 1 -~     6 mo infants in the interim.~   "
91856|NCT02364830|"~     Colpermin ® (Peppermint oil) is used in the treatment of Irritable Bowel Syndrome but~     Peppermint (Mentha x piperita) isn't native in Iran. So in this study the Enteric-Coated of~     Anise-oil will formulate and use in treatment of Irritable Bowel Syndrome with pain and~     bloating.~   "
91858|NCT02364804|"~     The purpose of this study is to evaluate the efficacy of anti-emetic drug Aprepitant upon the~     combination chemotherapy of nedaplatin and docetaxel for non-small cell lung cancer (NSCLC).~   "
91859|NCT02364791|"~     The purpose of this study is to explore whether the addition of Hemopatch to standard care~     can reduce prolonged air leaks and shorten the use of air drainage tube after surgery in~     thoracic lung surgery patients at high risk for prolonged air leaks.~   "
91929|NCT02363855|"~     The primary objectives of this study are to investigate the safety and tolerability of BAY~     1841788 in Japanese subjects with metastatic castration-resistant prostate cancer (mCRPC) and~     the PK of BAY 1841788 and its major metabolite BAY 1896953.~   "
91862|NCT02364752|"~     The aim of this 2-part study is to assess B-type natriuretic peptide (BNP) as well as other~     circulating and imaging biomarkers in myocardial function. Part 1 assesses biomarker levels~     in healthy participants and participants with cardiac dysfunction. Part 2 assesses BNP and~     other circulating biomarker levels, and performs imaging in participants with cardiac~     dysfunction who continued from Part 1. The primary hypothesis is that compared to healthy~     participants, biomarker levels are elevated in participants with mild/moderate and severe~     cardiac dysfunction.~   "
91863|NCT02364739|"~     Fertility knowledge and awareness is considered insufficient in women of reproductive age~     from developed countries. The objective of this study is to evaluate if educational~     interventions in oocyte donors increase on their level of fertility knowledge and awareness.~   "
91864|NCT02364726|"~     The purpose of this study is to find out the effects of acupuncture on reducing nerve damage.~      Acupuncture is a medical technique of inserting very thin needles into the energy points on~     the body with the aim to restore health and well-being. It has been used widely to treat~     pain, such as lower back pain and joint pain. In this study the investigators will assess if~     acupuncture can be used to ease the pain, tingling and numbness that may be caused by~     chemotherapy and improve quality of life during chemotherapy.~   "
91865|NCT02364713|"~     This randomized phase II trial studies how well oncolytic measles virus encoding thyroidal~     sodium iodide symporter (MV-NIS) compared to investigator's choice chemotherapy works in~     treating patients with ovarian, fallopian, or peritoneal cancer. Measles virus, which has~     been changed in a certain way, may be able to kill tumor cells without damaging normal cells.~   "
91866|NCT02364700|"~     This is an interventional pilot study investigating the feasibility of using the hand of hope~     (HOH) device for individuals with decreased hand function after stroke.~   "
91867|NCT02364687|"~     Detecting scarred heart muscle is important to diagnose and treat of a wide variety of heart~     conditions. Magnetic resonance imaging (MRI) can assess scarred heart muscle but it is time~     consuming, contraindicated for some patients and not tolerated by others. Computed tomography~     (CT) imaging has the potential to provide a rapid comprehensive assessment of the heart. This~     study will assess CT imaging of the heart muscle of patients who have previously undergone~     MRI of their heart. Using a state of the art CT scanner the investigators will develop a low~     radiation dose protocol to identify scarred heart muscle. The investigators will use and~     develop software techniques to analyse these images. This will enable us to develop a new way~     to identify and measure scarred heart muscle that will benefit patients with heart disease.~   "
91868|NCT02364674|"~     The objective of this study is to detect Bronchiolitis Obliterans Syndrome (BOS) in an early~     stage using the outcome parameters generated by Functional Respiratory Imaging (FRI). Robust~     and automated segmentation algorithms will be developed for these parameters, focusing on~     quantitative computed tomography (CT) image analyses to provide the physician a more~     sensitive diagnostics tool. The evolution of BOS over time will be monitored using non-rigid~     image registration methods.~   "
91869|NCT02364661|"~     Hepatitis B virus is a small DNA virus that affects 400 million people worldwide. The virus~     infects the liver and previous studies, done in tissue culture and in animals, have shown~     that viral replication is affected by metabolic changes occurring in the liver. Specifically,~     starvation induces HBV gene expression and replication, in parallel to the activation of the~     gluconeogenesis response, and feeding attenuates viral activity. In this study we are going~     to recruit HBV patients with detectable viremia and analyze their viral load after an over~     night starvation versus after a morning meal. Our hypothesis is that following an over-night~     starvation viral load will be higher than that in the fed state.~   "
91870|NCT02364648|"~     The purpose of this study is to examine the effect of mitochondria derived oxidative stress~     on vascular function in patients with moderate to severe Chronic Kidney Disease.~   "
91871|NCT02364635|"~     PRC 4016 (Icosabutate) - A Phase I, Single-Blind, Placebo Controlled, Single Oral Dose,~     Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects~      Objective:~        -  To assess the safety and tolerability of single ascending oral doses of icosabutate in~          healthy subjects~        -  To evaluate the pharmacokinetic (PK) parameters of icosabutate in healthy subjects~   "
91872|NCT02364622|"~     The purpose of this study is to determine whether using the flexible Trachway(R) intubating~     stylet could facilitate and promote the accurate placement of double-lumen endobronchial~     tube.~   "
91873|NCT02364609|"~     This phase I/Ib trial studies the side effects and best dose of pembrolizumab when given~     together with afatinib dimaleate in treating patients with non-small cell lung cancer that~     has spread to other places in the body and usually cannot be cured or controlled with~     treatment, or has come back and does not respond to erlotinib hydrochloride. Monoclonal~     antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and~     spread. Afatinib dimaleate may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Giving pembrolizumab and afatinib dimaleate together may be an~     effective treatment for non-small cell lung cancer.~   "
91874|NCT02364596|"~     The purpose of this study is to evaluate the safety and immunogenicity of a single~     vaccination of an investigational vaccine against Staphylococcus aureus (SA4Ag) in healthy~     adults aged 18 to <65 years.~   "
91883|NCT02364479|"~     This is a randomized, double-blind, multicentral clinical trial to investigate the efficacy~     and safety of Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc fusion protein~     injection (Yisaipu®) in the treatment of active axial spondyloarthritis(SpA). The primary~     purpose is to assess the different maintaining treatment programme in SpA patients with~     controlled inflammation by Yisaipu®. And the second purpose is to assess the eficacy and~     safety of Yisaipu® in axial SpAs. The trial will include 180 patients with stable NSAIDs~     therapy, and at the first stage they will receive 24-week full-dose of Yisaipu®. Then at the~     second stage the patients who achieve low disease activity (LDA, ASDAS<2.1) at 24th week will~     be randomizedly divided into three group: full-dose of Yisaipu® group, half-dose of Yisaipu®~     group and placebo group. And the blind stage will last for 24 weeks. Patients who complete~     the 48-week therapy or achieve disease-flare criteria during the blind stage would finish the~     study.~   "
91884|NCT02364466|"~     Prospective, observational cohort study of peripheral T cell lymphoma. Purpose is to~     investigate the complication including febrile neutropenia in the era of pegylated G-CSF~     prophylaxis.~   "
91875|NCT02364583|"~     This study specifically seeks to provide data on the safety, tolerability and pilot efficacy~     of short course, high dose primaquine treatment in Papua New Guinean children aged 5-10~     years, in a cross-sectional study design. Community screened asymptomatic cases and/or cases~     of clinically diagnosed malaria admitted to the out-patient units of the health center, will~     be screened for Glucose-6-phosphate dehydrogenase deficiency (G6PD) and malaria illness by~     rapid diagnostic test and P. vivax infection confirmed by light microscopy. Following~     treatment with artemether-lumefantrine (Coartem), G6PD normal children will be enrolled into~     the study and followed for 2 months. Primaquine treatment will be allocated to study~     participants in a step-wise design; firstly receiving the current 14 day treatment regimen of~     0.5 mg/kg total dose (n=40); secondly, a 7 day treatment regimen receiving a total dose of~     1.0 mg/kg/day; then thirdly, receive 1.0 mg/kg twice daily dose (bd) for a total of 3.5 days,~     should the 7 day treatment prove to be safe and well tolerated. In addition to this~     dose-escalation study, the pharmacokinetic profiles of single doses of 0.5 mg/kg and 1.0~     mg/kg will be determined using an intensive sampling protocol, in children aged 5-10 years.~     The pharmacokinetic profiles obtained by this sub-study will be essential for modeling the~     population pharmacokinetic data obtained from the dose-escalation study. As there is~     currently no data on the safety, tolerability and efficacy of primaquine in children, the~     present study will validate previous observation and contribute to the knowledge of~     primaquine as a treatment for liver stages of Plasmodium vivax infection.~   "
91876|NCT02364570|"~     Cardiovascular disease (CVD) is largely a lifestyle-related condition that is the #1 killer~     of adults in the United States. Our work is aimed at understanding how short-term increases~     in blood sugar, like those that accompany eating a meal, affect blood vessel function and the~     risk of CVD. This research is aimed at understanding how meals composed of eggs affect~     short-term increases in blood sugar from eating, which are connected with increased risk of~     CVD. In particular, the investigators are trying to identify a specific meal composed of~     either whole eggs, egg yolks, or egg whites, that best reduces acute increases in blood sugar~     brought on by meals that consist of majority carbohydrate. At the same time, the~     investigators are trying to explore the protective affects that eggs may have on blood vessel~     function and the reduction of CVD risk.~   "
91877|NCT02364557|"~     This randomized phase II/III trial studies how well standard of care therapy with~     stereotactic radiosurgery and/or surgery works and compares it to standard of care therapy~     alone in treating patients with breast cancer that has spread to one or two locations in the~     body (limited metastatic) that are previously untreated. Standard of care therapy comprising~     chemotherapy, hormonal therapy, biological therapy, and others may help stop the spread of~     tumor cells. Radiation therapy and/or surgery is usually only given with standard of care~     therapy to relieve pain; however, in patients with limited metastatic breast cancer,~     stereotactic radiosurgery, also known as stereotactic body radiation therapy, may be able to~     send x-rays directly to the tumor and cause less damage to normal tissue and surgery may be~     able to effectively remove the metastatic tumor cells. It is not yet known whether standard~     of care therapy is more effective with stereotactic radiosurgery and/or surgery in treating~     limited metastatic breast cancer.~   "
91878|NCT02364544|"~     The goal of the Improving Care and Reducing Cost (ICRC) Program, is to improve disease~     management and the overall process of care in treating the chronic illness schizophrenia in~     order to reduce ER visits and hospital days while providing better care, better health and~     increased patient satisfaction. This will be done by fostering innovation in the use of~     technology and by training and deploying a new cadre of personnel in the behavioral health~     field: Mental Health/Health Technology (MH/HT) Case Managers.~   "
91879|NCT02364531|"~     The purpose of this study is to temporally evaluate the impact of abiraterone acetate~     (ZYTIGA) therapy on Patient Reported Outcomes (PROs) and on clinical outcomes in the~     chemotherapy-naive metastatic castrate-resistant prostate cancer (mCRPC) population. Safety~     data, levels of health care resource utilization associated with abiraterone acetate (ZYTIGA)~     therapy will also be prospectively collected and analyzed.~   "
91880|NCT02364518|"~     The purpose of this study is to assess the safety and effectiveness of TranQuillTM Sling (a~     suture or thread used in surgery that is knotless) in snoreplasty (surgery procedure) for the~     treatment of snoring and mild OSA in adult subjects. The TranQuill Sling Snoreplasty (QSS) is~     a procedure where the suture will be inserted into the soft palate tissues for the treatment~     of snoring and/or mild obstructive sleep apnea. Soft palate tissues are tissues in the back~     of the roof of the mouth.~      The research results will be used to provide data on feasibility (strengths and weaknesses),~     safety, performance, and effectiveness data for the Surgical Specialties, Inc as a therapy~     for snoring and/or mild obstructive sleep apnea. The TranQuillTM Sling is approved by the~     U.S. Food and Drug Administration (FDA). The TranQuillTM Sling is used in all types of~     surgery that involved deep tissues in the body.~      The investigator in charge of the study is Dr. Boyd Gillespie. MUSC and Dr. Gillespie receive~     financial support from Surgical Specialties, Inc. to conduct the study. MUSC is the only~     place that this study will be conducted. For this research study the investigators plan to~     enroll a total of up to 20 subjects at the Medical University of South Carolina.~   "
91881|NCT02364505|"~     The aim of the project is to investigate the impact of a multiple sclerosis specific~     telemedicine mindfulness-based Intervention on the quality of life of people with multiple~     sclerosis and their caregivers.~   "
91882|NCT02364492|"~     The purpose of this study is to evaluate if a maximum tolerated dose (MTD) can be obtained~     following 2 administrations of the MAG-Tn3 + AS15 cancer vaccine when administered at doses~     of 30 µg, 100 µg or 300 µg IM every three weeks.~   "
91912|NCT02364089|"~     The general objective is to evaluate the consequences of surgical removal of SCSI on~     hypertension and cardiovascular risk factors in order to determine on an evidence-based basis~     if surgical excision of SCSI is preferable to an intensive medical regimen in patients with~     hypertension.~   "
91913|NCT02364076|"~     This is a non-randomized clinical trial in patients with thymic carcinomas who failed prior~     systemic therapy. All subjects will receive pembrolizumab and epacadostat treatment in three~     week cycles until unacceptable toxicity, death, progressive disease or withdrawal.~   "
91914|NCT02364063|"~     This study evaluates the effectiveness of a voiding reeducation program as treatment for~     incontinence in children with a brain injury.~   "
91885|NCT02364453|"~     The purpose of this study is to determine the effects of antihistamine (Clemastin) on~     migraines triggered by pituitary adenylate cyclase activating peptide-38 (PACAP38) as well as~     on biochemical markers for mast cell degranulation in migraine patients. Also, to investigate~     the occurrence of migraine in migraine patients after infusion of PACAP38 in lower dosages~     than previously investigated. As this has never been done before it is unknown how a lower~     dose of PACAP38 will affect 1) the incidence of migraine attacks, 2) the accompanying~     symptoms, 3) head pain characteristics, and 4) debut and duration of migraine attacks.~      Our three hypotheses are:~        1. Pre-treatment with Clemastin reduces PACAP38 sensitivity and inhibits development of~          migraine in migraine patients.~        2. Clemastin inhibits the increase in plasma concentration of TNF-alpha, histamine and~          tryptase after PACAP38-infusion.~        3. PACAP38 in lower dosages (4, 6 and 8 pmol/kg/min) induces migraine in migraine patients.~   "
91886|NCT02364440|"~     Enrolled subjects will receive Ultherapy™ System treatment on the back of their both hands.~     Follow-up visits will occur at 90 days post-treatment. Study photos will be obtained~     pre-treatment and at 90 days post-treatment~   "
91887|NCT02364427|"~     Acute Kidney Injury is a condition where your kidneys suddenly stop working properly and~     usually occurs if you are already unwell with an illness and can happen after having surgery.~     Having an episode of acute kidney injury increases the risk of progression to chronic kidney~     disease (CKD) later on and decreases long-term survival. It also has a major socioeconomic~     impact with regards to admissions and length of hospital stay. There is currently no~     universally accepted treatment or method of identifying patients that are at risk. The~     investigators aim to measure arterial stiffness in patients prior to them undergoing cardiac~     surgery to investigate whether this measurement is associated with an increased risk of~     patients developing acute kidney injury after surgery. The investigators are planning to~     measure arterial stiffness, and examine a blood sample, for kidney health-related levels to~     determine whether there is an association between those patients who have stiff arterial~     vessels and those patients who may develop acute kidney injury after surgery.~   "
91888|NCT02364414|"~     The purpose of this study is to compare the accuracy of measurements derived from a~     commercially available direct intra-oral scanning system with those taken from plaster study~     models, and to compare cost implications of both systems.~      The investigators will test the hypotheses:~        -  There is no systematic difference between measurements taken from the Trios scanner and~          study models.~        -  There is no difference in the cost of producing digital models.~   "
91889|NCT02364401|"~     The purpose of this study is to compare the efficacy of catheter ablation for atrial~     fibrillation between contact force-guided and impedance-guided annotation using automated~     annotation system (Visitag™). Patients who receive atrial fibrillation ablation are randomly~     assigned in the same number to two groups with impedance guided ablation and contact force~     guided ablation using contact force sensing catheter (THERMOCOOL® SMARTTOUCH™ catheter,~     Biosense Webster, Inc., Diamond Bar, CA).~   "
91890|NCT02364388|"~     Imagio breast imaging system, is an opto-acoustic (OA) imaging system designed to~     concurrently collect images in conjunction with diagnostic ultrasound ( co-registered OA and~     B-mode imaging). This medical device has CE-marking and is approved for use in Europe and~     other nations.~      This is a post-market, non-randomized multi-center surveillance study.~   "
91891|NCT02364362|"~     Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and~     Flt3. Phase I study has shown that the toxicity is manageable.~      This study assessed the safety and maximum tolerated dose of continuous daily treatment with~     Famitinib plus docetaxel (60 mg/m^2, every 3 weeks) in patients with Advanced Non-squamous~     and Non-Small Cell Lung Cancer (NSCLC) to determine the recommended dose for the Phase II~     trial.~   "
91892|NCT02364349|"~     This double-blinded randomized clinical trial investigates any differences in allergic~     responses elicited by Bee Venom (BV) and Essential Bee Venom (eBV).~   "
91893|NCT02364336|"~     Background:~      - Chronic hepatitis B is caused by a virus that infects the liver. Cure is not possible but~     the virus can be controlled with the use of antiviral medicines,. Researchers think that~     adding a second antiviral medicine might help.~      Objective:~      - To understand how peginterferon might help treat people with chronic hepatitis B. Also, to~     see if peginterferon is safe to use with other antiviral medications.~      Eligibility:~      - Adults age 18 and older who have chronic hepatitis B and had therapy with 1 or more oral~     medicines for hepatitis B for at least 4 years.~      Design:~        -  Participants will be screened with physical exam and medical history. They will complete~          health questionnaires about their levels of fatigue and pain. They will have blood and~          urine tests. They may have an eye exam.~        -  Participants also will have a Fibroscan. A test to measure how stiff your liver is.~        -  Eligible participants will have a liver biopsy. Blood will be drawn.~        -  Participants will be admitted to the NIH Clinical Center. They will be injected with the~          study drug. Then they will have a second liver biopsy. They will be discharged 24 hours~          later.~        -  Participants will give themselves study drug injections under the skin weekly for 24~          weeks.~        -  Participants will have 5 clinic visits during the 24-week treatment period. Then they~          will have follow-up visits every 12 weeks for 48 weeks.~        -  During visits, participants may have a physical exam and medical history. They may have~          blood and urine tests. They may have a Fibroscan and complete questionnaires. At the~          final visit, they will also have a Fibroscan.~   "
91915|NCT02364050|"~     Prospective data collection of a consecutive series of elderly patients with large B-cell~     lymphoma newly diagnosed, receiving before the start of treatment Multidimensional Geriatric~     Assessment (VGM) through the use of Activity of Daily Living (ADL), Instrumental Activity of~     Daily Living (IADL) and Cumulative Illness Rating Scale for Geriatrics (CIRS-G).~   "
91930|NCT02363842|"~     The study is a multi-center, prospective, randomized, controlled, clinical study evaluating~     the effects of microclimate management using Skin IQ™ MCM coverlet placed over commercially~     available pressure redistribution surfaces compared to standard of care (SOC). The objective~     of this study is to evaluate if a commercially available pressure redistribution surface when~     combined with the Skin IQ™ MCM coverlet will significantly reduce pressure ulcer (PU)~     incidence as compared to use of a commercially available pressure redistribution surface by~     itself by decreasing the effects of excessive moisture and temperature at the skin and~     surface interface.~   "
91894|NCT02364323|"~     The risk of diabetic kidney complications includes non-modifiable risk factors such as~     genetic predictors, as well as modifiable risk factors such as hyperglycaemia, hypertension,~     hyperlipidaemia and proteinuria. Genetic testing for personalized medicine is increasing in~     popularity, though evidence that genetic testing can empower patients to modify behaviour and~     reduce clinical risk remains lacking. In this project, the investigators aim to utilize a~     personalized risk counseling with genetic testing to evaluate its impact on risk factor~     control in diabetic patients. The investigators hypothesize that knowledge of genetic +/-~     clinical risk will empower patients and lead to improvement in the number of treatment~     targets achieved. The investigators will recruit 400 patients with diabetes. All subjects~     will undergo a comprehensive assessment of the risk of diabetic complications based on~     clinical risk factors. Half of the patients will be randomized to receive additional genetic~     testing of a panel of genetic markers proven to predict renal complications in our~     population: ACE I/D, aldose reductase (CA)n and PRKCB1 gene polymorphisms. The results of~     personalized risk assessment will be communicated by a health counsellor in the intervention~     arm. The impact of testing and patient knowledge of the result of genetic testing on~     achievement of treatment targets (A1c, BP, LDL-cholesterol, TG, use of ACEI/ARB) and patient~     behavior will be evaluated after 12 months. The other arm will receive results of the genetic~     testing at the completion of the study period. The study will help towards developing a~     strategy to empower patients through structured and personalized risk assessment will provide~     a novel approach to identify high-risk subjects for early intensive management, and may lead~     to reduction in long-term complications.~   "
91895|NCT02364310|"~     Medico-economics assessment (cost-effectiveness) of the unilateral carotid barostimulation~     with Barostim NeoTM compared to usual care in patients with resistant hypertension~     (multicenter randomized, PROBE trial), followed-up for 12 months, with a lifetime-long~     modeling.~   "
91896|NCT02364297|"~     In the last years, important advances have been done in the treatment and prevention of~     fundal variceal bleeding in patients with cirrhosis. Experts agree that the combination of~     pharmacological and endoscopic therapy (with tissue adhesives) should be the first line~     therapy in the acute bleeding episode from isolated gastric varices (IGV1) or type 2~     gastroesophageal varices (GOV2) varices; whereas transjugular intrahepatic portosystemic~     shunt (TIPS) is considered a rescue therapy. TIPS has been shown to effectively prevent~     variceal rebleeding but with a potential increase in the incidence of hepatic encephalopathy~     and/or liver failure. In this sense, a recent randomized controlled trial (RCT) in esophageal~     variceal bleeding showed that an early TIPS, performed during the first 72h after patient~     admission resulted in a significant decrease in failure to control bleeding and early and~     late rebleeding. Moreover, survival was also significantly increased as well as other~     portal-hypertension related complications (ascites, spontaneous bacterial peritonitis,~     hepatorenal syndrome, etc).~      The present study is directed at comparing the outcome of patients with acute bleeding from~     fundal varices (IGV1 or GOV2) treated by standard therapy (vasoactive drugs + endoscopic~     injection of tissue adhesives) with or without early TIPS (performed during the first 1-5~     days after admission). Main end-point will be survival free of variceal rebleeding at 1 year~     from inclusion.~   "
91897|NCT02364284|"~     Reporting patterns and results of initial antibiotic treatment in patients with complicated~     urinary tract infection (cUTI), complicated intra-abdominal infection (cIAI) and nosocomial~     pneumonia (NP) including ventilator-associated pneumonia (VAP) - RECOMMEND Study~   "
91898|NCT02364271|"~     The investigators hypothesize that coronary artery calcium score (CACS), heart-type fatty~     acid binding protein (H-FABP) concentration, high-sensitive troponin t (hs-cTnT)~     concentration and Thrombolysis in Myocardial Infarction (TIMI) score positively correlate~     with the rate of the major adverse cardiac events (MACE) at 30 days and 6 months in patients~     presenting to the ED with suspected acute coronary syndrome (ACS).~      The aims of the present study in patients with chest pain of uncertain cardiac cause and a~     non-ischaemic initial electrocardiogram (ECG) presenting to the ED are~        1. To investigate whether there is any correlation between CACS, H-FABP concentration,~          hs-cTnT concentration and modified TIMI score with the MACE rate at 30 days and 6~          months;~        2. To evaluate the predictive values of CACS, H-FABP, hs-cTnT, modified TIMI score and~          various combinations.~      Study design and participants This prospective observational study was conducted in the~     Prince of Wales Hospital in Hong Kong.~      Chest pain adult patients suspected with acute coronary syndrome were recruited.~     Point-of-care H-FABP and hs-cTnT tests, TIMI score and CT scan for coronary calcium score~     were performed on study subjects. Patients were followed-up at 30-day and 6 months for the~     occurrence of major adverse cardiac events.~      In 2014, a modified HEART score incorporating hs-cTnT was included as one of the predictors~     under study alongside with modified TIMI score, FABP and CACS. The HEART score was completed~     retrospectively.~   "
91899|NCT02364258|"~     This will be a single center, open label, randomized, cross-over study in patients with~     dyslipidemia comparing the pharmacokinetics of rosuvastatin and atorvastatin in patients with~     greater than or equal to one variant allele in the SLCO1B1 gene (-11187 and/or c.521) to~     patients with the wild-type/wild-type genotype.~      The studies goal is to establish the role of genetic variation and development in key~     transporters on the dose-exposure relationship of two commonly used statin drugs in children.~     This study is the first step in a series of investigations aimed to determining the~     mechanisms behind variations in physiologic response, clinical efficacy and significant~     adverse effect risk that surround the statin drugs in children and adolescents.~   "
91900|NCT02364245|"~     The purpose of this study is to design and evaluation the feasibility, effects of~     Kinect-based Computer Games as Upper Extremity Training Tool in Children with Cerebral Palsy.~   "
91901|NCT02364232|"~     The purpose of this study was to compare the treatment effects of home-based or clinic-based~     bilateral training with and without mirror feedback programon on physiological markers,~     sensorimotor, cognition, daily functions, and participation among patients with chronic~     stroke.~   "
91902|NCT02364219|"~     The primary purpose of this study is to determine whether a prewarming period of at least 30~     minutes during induction of general and combined epidural anesthesia reduces the core~     temperature drop normally occuring in patients undergoing cyto-reductive and major abdominal~     surgery. In addition the effect of prewarming on intra and postoperative body core~     temperature will be evaluated.~   "
91903|NCT02364206|"~     Glioblastomas are extremely resistant to treatment, including radiotherapy and/or~     chemotherapy. Mitogen-activated protein kinase (MAPK) cascades are key signaling pathways~     involved in the regulation of normal cell proliferation, survival and differentiation.~     Activation of p38 MAPK has been associated with a poor prognosis among patients with~     glioblastoma during the temozolomide (TMZ) era and represents a compensatory response by~     tumor cell to environmental stress such as radiation or chemotherapy.~      LY2228820 is a potent and selective inhibitor of p38 MAPK, and reduces phosphorylation of its~     cellular target, MAPK-activated protein kinase 2 (MAPKAPK-2) . LY2228820 is a good candidate~     to target malignant glioma resistance to the gold standard treatment combining radiation and~     TMZ by acting on both tumor and stromal cells.~      The primary objectives of this study were to determine the recommended dose of LY2228820 in~     combination with TMZ and radiotherapy during chemoradiotherapy period (phase I) and to~     estimate the 6-month progression free survival (PFS) rate of patients treated with LY2228820~     when administered at the recommended dose in combination with radiotherapy and concomitant~     TMZ (phase II)~   "
91904|NCT02364193|"~     Heart failure (HF) is a major health problem, which is characterized by reduced cardiac~     function leading to pulmonary congestion. Most episodes of acute HF requiring unplanned~     hospitalization are due to pulmonary congestion. There is an urgent clinical need for~     quantitative, reproducible, minimally invasive, and noninvasive methods to assess thoracic~     fluid status. The potential value of dynamic contrast-enhanced magnetic resonance imaging~     (DCE-MRI) to this end has been suggested and demonstrated in-vitro. In this study the~     investigators aim to compare intra-thoracic fluid volume assessed by DCE- MRI using bolus~     kinetic parameters of the indicator dilution theory and bioimpedance spectroscopy (BIS).~      Primary objectives: This study evaluates the correlation between change in BIS and change in~     bolus kinetic parameters in response to a fluid challenge.~      Secondary objectives: The sensitivity of the bolus kinetic parameters to fluid challenges and~     the normal range DCE-MRI bolus kinetic parameters is evaluated in healthy subjects.~      Study design: Prospective nonrandomized pilot study.~      Study population: Healthy volunteers.~      Intervention: The subjects will receive an intra-venous injection of gadolinium, a MRI~     contrast agent. External pressure will be applied by means of a leg-compression device in~     order to induce a rapid increase of the preload by blood auto-transfusion.~      Main study parameters: Pulmonary transit time (PTT), skewness of the indicator dilution curve~     which is a measure of trans-pulmonary dilution, intrathoracic blood volume (ITBV), changes in~     bolus kinetic parameters, and thoracic impedance in response to fluid challenges. The~     correlation between changes in bolus kinetic parameters and thoracic impedance in response to~     fluid challenges.~   "
91905|NCT02364180|"~     We intend to measure evoked EMG at two sites in subjects who are chronically taking~     pyridostigmine.~   "
91906|NCT02364167|"~     The study entitled Acupuncture vs. placebo acupuncture and vs. standard therapy for pain~     control after elective caesarian section - a randomized controlled trial aims to investigate~     whether acupuncture with indwelling fixed needles reduces pain and analgesic requirement as~     compared to placebo and standard therapy in patients after after elective caesarian section~     (CS) in the period from January 2015 to May 2016.~      For that purpose 180 adult patients scheduled to elective elective CS in spinal anesthesia~     will be recruited according to eligibility criteria. 120 patients will be randomized either~     to verum or placebo acupuncture, 60 patients will be included in non-randomized standard~     therapy arm. The outcome measures are: postoperative analgesic requirement, pain intensity,~     incidence of side effects and physiological parameters.~   "
91907|NCT02364154|"~     The hypothesis of the present study is that metabolic phenotyping of blood plasma allows to~     (i) discriminate between colorectal cancer patients and control subjects and (ii) identify~     new biomarkers for colorectal cancer. In order to test this hypothesis, the investigators~     will apply proton nuclear magnetic resonance (1H-NMR) spectroscopy to perform metabolic~     phenotyping of blood plasma in 50 colorectal cancer patients and 50 control subjects.~     Multivariate statistics will be performed to assess the discriminative power of the applied~     methodology in distinguishing between both groups and to identify metabolites with potential~     as biomarkers for colorectal cancer.~   "
91908|NCT02364141|"~     The aim of this study was to evaluate the long-term effects of the task-specific training~     with trunk restraint comparing to the free one in post-stroke reaching movements. Twenty~     hemiparetic chronic stroke patients were selected and randomized into two training groups:~     Trunk restraint group - TRG (reaching training with trunk restraint) and Trunk free group -~     TFG (unrestraint reaching). Twenty sessions with forty-five minutes of training were~     accomplished. The subjects were evaluated in pre-treatment (PRE), post-treatment (POST) and~     three months after the completed training (RET). The measures administered were the Modified~     Ashworth Scale, Barthel Index, Fugl-Meyer Scale and kinematic analysis (movement trajectory,~     velocity, angles).~   "
91909|NCT02364128|"~     At least 15 million Americans are morbidly obese, or more than 100 pounds overweight. Medical~     treatments including drugs and behavior modification have proven ineffective in producing~     significant and lasting weight loss in this group. While bariatric surgery is extremely~     effective for most patients, it also carries risks for both short and long-term~     complications. There are currently four different types of bariatric surgery available and~     the risks and benefits of these procedures vary widely and are strongly affected by patient~     and clinical characteristics.~      Decision making under these circumstances should reflect informed patient's values and~     preferences regarding these trade-offs. Instead, the choice of bariatric procedure is more~     often driven by the beliefs and experiences of the bariatric surgeon that a patient happens~     to see. Variability in the type of surgery recommended to patients likely results from some~     combination of surgeons' subjective opinions and personal experiences with regard to the~     risks and benefits of the treatment options and delegated decision making on the part of~     patients.~      The goals of this research proposal are to develop, implement, and evaluate an informed~     decision support tool for treatment of morbid obesity. This project will be conducted within~     the context of the Michigan Bariatric Surgery Collaborative (MBSC), which is a statewide~     clinical registry and quality improvement program that has the participation of virtually~     every bariatric surgeon and program in the state of Michigan. The MBSC registry now includes~     externally audited clinical data for more than 80,000 consecutive bariatric surgery patients.~     MBSC outcome measures include complications occurring within 30 days as well as weight loss,~     comorbidity resolution, quality of life and satisfaction at 1, 2, and 3 years after bariatric~     surgery.~   "
91910|NCT02364115|"~     The purpose of the study is to investigate effectiveness of stereotactic body radiotherapy in~     patients with bone metastatic disease.~   "
91911|NCT02364102|"~     The investigators aim to study whether hypothyroidism negatively affects Brown adipose tissue~     (BAT) function in humans and whether BAT function can be restored to normal by thyroid~     hormone supplementation.~   "
91916|NCT02364037|"~     The investigators study is testing models of contraceptive care that were developed as part~     of the Contraceptive CHOICE Project. CHOICE is a prospective cohort study of 9,256 women~     designed to: 1) promote the use of long-acting reversible contraceptive (LARC) methods which~     include interuterine devices (IUD) and subdermal implants; 2) remove financial barriers to~     contraception; 3) evaluate continuation of and satisfaction with reversible methods; and 4)~     reduce unintended pregnancies in the St. Louis region. CHOICE demonstrated that interventions~     such as comprehensive contraceptive counseling, increased access, and removal of financial~     barriers increase the uptake of LARC methods and reduce unintended pregnancy. The~     investigators objective is to determine whether the CHOICE model of contraceptive care can be~     equally successful in the real world of community clinics.~   "
91917|NCT02364024|"~     The purpose of this study is to confirm that linear quantification of CD3+ cells is a~     prognostic biomarker in localized colorectal carcinomas.~   "
91918|NCT02364011|"~     The purpose of this investigation is to determine both patient-reported and performance-based~     outcomes, specifically muscle function and kinematic/kinetic outcomes, between four different~     surgical total knee prostheses in individuals following TKA. Change scores will be determined~     based on patient-reported outcomes, kinematic/kinetic data, knee extension strength/power,~     static/dynamic balance control, mobility measures and functional performance testing during~     functional tasks (i.e. walking, ascending/descending stairs, sit-to-stand). After evaluating~     the pattern of change in lower-extremity function, the investigators will be better prepared~     to address residual functional impairments and prognostic factors linked to maximal recovery~     over two years.~   "
91919|NCT02363998|"~     The purpose of this Phase 3 open-label treatment study is to evaluate the safety and~     effectiveness of lofexidine at a clinically relevant dose to alleviate symptoms of acute~     withdrawal from any opioid, including methadone and buprenorphine. This study will take place~     in a variety of clinical scenarios, both in-clinic and outpatient settings.~   "
91920|NCT02363985|"~     The combination of infectious diseases and malnutrition is the most prevalent, preventable~     public health problem in the world, responsible for millions of deaths annually, particularly~     in infants and children. Approximately 13 million children die each year in developing~     countries from infectious diseases, with the majority of these deaths related to~     malnutrition. The relationship between infections and malnutrition is synergistic, each~     further compromising the outcome of the other. Malnutrition compromises natural immunity~     leading to increased susceptibility to infections, more frequent and prolonged disease~     episodes, and increased severity of disease. Likewise, infections can aggravate or~     precipitate malnutrition through decreased appetite and food intake, nutrient malabsorption,~     nutrient loss or increased metabolic needs. Another issue is that infections (as well as~     overweight and obesity status) affect nutritional biomarkers making it difficult to assess~     the real magnitude of some nutritional problems. This is the case of vitamin A. Vitamin A~     deficiency is defined to be of severe public health importance if 20% or more of a defined~     population has a serum retinol concentration of less than 0.7 µmol/L. However, circulating~     concentrations of serum retinol are reduced by infections and in such situations serum~     retinol concentration is not a good indicator of vitamin A status. Serum acute-phase proteins~     can indicate the severity and duration of an infection. Correcting vitamin A deficiency is~     addressed in Ethiopia through vitamin A supplementation of children, dietary diversity and~     using bio-fortified foods. However, assessing vitamin A status, and the effectiveness of~     government interventions, is challenging in settings where infectious diseases are endemic,~     as in most area of the country. Evaluation of vitamin A status is relatively insensitive when~     based on changes in serum retinol concentrations, which are homeostatically controlled and~     negatively affected by subclinical infections. Liver stores of vitamin A, the best indicator~     of vitamin A status, cannot be routinely evaluated. The isotope dilution technique is the~     preferred method for determining vitamin A status and assessing the efficacy and~     effectiveness of intervention programs aimed at improving vitamin A status. It is the only~     indirect assessment method that provides a quantitative estimate of vitamin A status across~     the continuum of deficient to excessive stores.~   "
91921|NCT02363972|"~     A prospective single-arm well-controlled study to evaluate the safety and effectiveness of a~     less invasive means of establishing vascular access to facilitate dialysis in patients with~     end stage renal disease.~   "
91922|NCT02363959|"~     The objective of this study is to evaluate the effect of hyperbaric oxygen therapy (HBOT) on~     airway complications in post-lung transplant recipients with evidence of restricted levels of~     blood and oxygen in the airway tissue. Study subjects with extensive airway tissue damage in~     the early post-transplant period will be randomized to HBOT or usual care and followed~     clinically for 12 months following randomization. The investigators hypothesize that HBOT~     will decrease the number of airway complications in the treated subjects.~   "
91923|NCT02363946|"~     The purpose of the study is to determine the safety and tolerability of escalating doses of~     ARC-AAT and to evaluate the pharmacokinetics of ARC-AAT and the effect of ARC-AAT on~     circulating levels of alpha-1 antitrypsin. The study will consist of two parts, Part A~     (conducted in healthy volunteers) and Part B (conducted in AATD patients) at up to 9~     escalating dose levels with 6 participants per dose level.~   "
91924|NCT02363933|"~     This is a Phase 2 single-arm study to assess the efficacy of perampanel as an adjunctive~     anti-epileptic drug (AED) in patients with primary glioma that are presenting refractory~     partial onset seizure activity (defined as 3 or more seizures in a 28-day period). In this~     study, patients will be started on a dose of 2 mg of perampanel daily taken orally at bedtime~     for 2 weeks. At the start of week 3 perampanel will be titrated up in dose in 2mg increments~     per week up to 8mg daily, as long as it is well tolerated by the patient. The highest dose of~     perampanel will be 8 mg orally at bedtime. Once this is achieved, patients will remain on a~     maintenance dose of 8 mg for 12 more weeks. The planned treatment dose is 8mg, but the dose~     can be modified by the physician based on patient reported tolerability. Titration and taper~     periods will be determined by the physician in the case where patients do not reach the~     planned treatment dose of 8 mg daily. Patients will be assessed in the Brain Tumor Center~     Clinic every 8 weeks. Study assessments will be made at enrollment, 8 weeks, 16 weeks, and 24~     weeks. Assessments will include history and physical examination (H&P) including Karnofsky~     Performance Status (KPS), neurological examination, evaluation of seizure history,~     patient-reported outcomes of QoL, and computer based neurocognitive testing. After a total of~     16 weeks of therapy, perampanel will be tapered down. At Week 17, patients will begin taking~     6mg of perampanel, Week 18 4mg, Week 19 2mg, and Week 20 they will no longer take perampanel.~     Patients will be considered off treatment at the end of week 20, once perampanel has cleared~     their system. Patients will then be monitored through Week 24. Patients will continue to take~     their original AED regimen after they stop perampanel. If seizure control is achieved during~     the maintenance period or if seizures occur during the tapering period, patients can be~     continued on perampanel per the discretion of the treating physician. In this instance,~     perampanel will be prescribed by the treating physician and not provided within the confines~     of the study. Efficacy will be assessed using a log of patient-reported seizure activity. As~     is standard procedure at the Preston Robert Tisch Brain Tumor Center (PRTBTC), patients will~     be given a log to record the number of seizures that occur. Research team members will~     regularly contact patients for reminders and reports from the log. Safety will be assessed~     with the following laboratory evaluations: complete blood count (CBC) with differential,~     complete metabolic panel (CMP), and toxicity assessment.~   "
91925|NCT02363920|"~     Nasal High Oxygen Flow (HOF) has been demonstrated to reduce the re-intubation rate in~     hypoxic patients and ameliorate breathing pattern in hypercapnic patients.~      The aim of this study is to better understand the physiological mechanism underlying these~     results, assessing the respiratory mechanics in stable hypercapnic COPD patients.~   "
91926|NCT02363907|"~     The purpose of this study is to evaluate the effectiveness and safety of the Dexcom G4 System~     when used as an adjuvant to blood glucose testing over a 7-day period in people 2 to 17~     years-old with diabetes mellitus.~   "
91931|NCT02363829|"~     Patients 18 years of age and older with clinical stages IIA, IIB, IIIA, IIIB, IVA cervical~     carcinoma limited to the pelvis will receive twice daily oral nelfinavir (NFV) and weekly IV~     cisplatin in combination as radiosensitizers with daily whole pelvic external beam and~     intracavitary radiation brachytherapy.~   "
91932|NCT02363816|"~     Weight gain, hypertension, high cholesterol and sugar abnormalities in childhood are strongly~     linked and predict the risk of further complications and early death in adulthood. The newer~     antipsychotics, called the second generation antipsychotics are commonly used to treat mood~     disorders in adult and pediatric populations. Their use has substantially increased (up to~     5-fold) in the past 15 years in children due to their approved use by the Food and Drug~     Administration and higher acceptance in the general medical community. However, second~     generation antipsychotics are known to have very damaging side effects that cause children to~     gain substantial amounts of weight, have high cholesterol, high blood pressure and high sugar~     levels. Despite the known risks their use is still needed and may be contributing to the high~     rates of obesity-related diseases in childhood and ultimately shorter life-spans in~     adulthood. How second generation antipsychotics cause these side effects is still not well~     known. Preliminary evidence has identified a novel pathway that may be associated with second~     generation antipsychotic side effects. This pathway has not been studied, is involved in~     vitamin A metabolism and is called the beta-carotene pathway. Beta-carotene is an important~     part of our diet because it acts as an anti-oxidant (fights harmful oxidative stress in the~     body) and it produces the active form of vitamin A which is essential for several processes~     in our body. The investigator's work has identified a backup in this pathway which the~     investigators hypothesize is due to genetic variation of the enzymes found within this~     pathway.~      The investigators hypothesize that genetic variation in the beta-carotene pathway is~     responsible for the side effects associated with second generation antipsychotics. The~     investigators want to complete a cross-sectional, pilot study in the pediatric population~     that will be used for future prospective, extramural applications.~      The investigators propose two aims for this study:~      Aim 1: Determine how second generation antipsychotics change beta-carotene metabolism. For~     this aim, the investigators hypothesize that high beta-carotene:retinoic acid ratios will be~     due to genetic varition in the beta-carotene pathway.~      Aim 2: Define the relationship between beta-carotene metabolism, oxidative stress and second~     generation antipsychotic induced insulin resistance. For this aim the investigators~     hypothesize that low beta-carotene levels will be associated with high oxidative stress~     levels and insulin resistance.~   "
91933|NCT02363803|"~     Diabetic nerve pain [painful diabetic peripheral neuropathy] is a common medical problem with~     few reliably effective treatments. There is some evidence that sensory testing may help~     determine how individuals will respond to analgesic therapy. In this study, the investigators~     are evaluating the relationship between sensory testing and subject response to lidocaine~     infusion therapy.~   "
91934|NCT02363790|"~     This study is comparing the outcomes patients undergoing LVHR, PFC as opposed to a bridged~     repair with assessment of patient reported satisfaction and function at 6 months of~     follow-up.~   "
91935|NCT02363777|"~     Design: Level I randomized prospective outcomes study comparing two groups of patients. One~     group will receive bupivacaine and dilaudid thoracic epidural analgesia (PCA)~     post-operatively. The other will receive bilateral ultrasound guided paravertebral blocks~     with indwelling paravertebral catheters with an infusion of 0.2% ropivicaine post-operatively~     and a PCA.~      Sample Size: 50 patients Study Duration: Approximately 12 months Population:. Patients~     presenting to the University of Minnesota Medical Center for elective open pancreatic~     surgery.~      Primary Objective: To determine if bilateral paravertebral catheters in patients with open~     pancreatic procedures result in decreased pain compared to patients treated with thoracic~     epidural for post-operative pain.~      Secondary Objectives:~        1. To determine whether the use of bilateral paravertebral catheters impacts the length of~          ICU and hospital stay for patients, compared to a thoracic epidurals in patients~          undergoing elective open pancreatic surgery.~        2. To determine whether the use of ultrasound guided bilateral paravertebral catheters~          leads to lower risk of complications, compared to use of a thoracic epidural in patients~          undergoing open pancreatic surgery.~   "
91936|NCT02363764|"~     Accurate identification of lower respiratory tract pathogens is standard of care in the~     management of CF patients and it is therefore recommended to perform regular bacterial~     cultures, at least once a year, but some even recommend monthly cultures. This can be done~     through different methods, of which sputum and bronchoalveolar lavage (BAL) are the gold~     standard. However, BAL is an invasive method, not designated to repeat monthly. Therefore,~     the diagnosis of lower respiratory tract infections can be challenging in the~     non-expectorating CF patient. Other methods, such as induced sputum (IS), cough swabs and~     nasal swabs, have been developed to obtain bacterial cultures in these patients. Studies have~     investigated the reliability of these different sampling methods, however, with controversial~     conclusions.~   "
91937|NCT02363751|"~     Open-label, non-randomized, multicenter, phase II, single arm non comparative trial~     evaluating toxicity and efficacy of gemcitabine plus platinium salt in combination with~     bevacizumab in first-line setting in metastatic collecting duct carcinoma.~   "
91938|NCT02363738|"~     Studies show the presence of immuno-inflammatory disturbances in individuals with Bipolar~     Disorders (BD). Increased levels of circulating proteins known as cytokines that promote~     inflammation have been consistently reported in individuals with bipolar disorders. A~     particular cytokine referred to as Tumor Necrosis Factor (TNF)-alpha is among those cytokines~     that have been consistently identified across depressive, manic, and euthymic periods.~     Disturbances in inflammation however, are not seen in all individual with bipolar disorder.~     Those individuals with signs of inflammation also often present with higher prevalence of~     medical disorders that are also associated with inflammation. Those individuals with~     significant signs of inflammation may respond to anti-inflammatory treatments. In this study,~     individuals with bipolar depression who exhibit signs of high inflammation will be enrolled~     and treated with either an anti-inflammatory biologic known as infliximab or placebo~     (saline).~   "
91939|NCT02363725|"~     Background:~      Colchicine is an old well-known venerable drug routinely used in gout attacks for instance.~      More recnetly it is regularly use in the treatment of pericarditis. It couls exert~     antiiflammatory effects targeting the adverse inflammation occuring incase of acute~     myocardial infarction, which is involved in poor outcomes or longer stay at hospital.~      Endpoints:~        -  Main endpoint: AUC CRP during the initial hospital stay~        -  Secondary endpoints:~             -  Clinical: oucomes~             -  Imaging: ETT, MRI~             -  Biological: various biomarkers~      Method Randomized, controled, open-labbelled, comparing two parallel arms: conventionnal~     optimal treatment versus conventionnal optimal treatment + colchicine~   "
91940|NCT02363712|"~     Painful knee osteoarthritis is common and treatments, short of knee replacement, are limited.~     The investigators plan to test the efficacy of a novel promising device for treatment of knee~     osteoarthritis affecting the inner part of the knee, the most common location. There are no~     disease modifying treatments available and therefore there is an emphasis on conservative~     management techniques to benefit individuals. Many of these treatments (insoles, braces,~     physiotherapy etc) have been shown to have relative success in individuals but a new novel~     device is demonstrating better effectiveness in this patient group. APOS (All Phases of Step)~     therapy consists of a shoe oriented system of care that works by shifting the load across~     parts of the knee and retraining the lower extremity muscles. Preliminary data suggest~     impressive favourable reductions in knee pain and a commensurate decrease in knee loading~     during walking. However, APOS treatment has never been evaluated in a randomised controlled~     trial even though it is widely used among Bupa members and in other parts of the world. In~     addition, no study has fully investigated the mechanism in which this treatment is aiding~     knee pain, whether it is primarily a biomechanical (mechanics of movement) alteration, a~     muscle strength and control change, or a combination of the two. The investigators propose to~     conduct a randomised blinded controlled trial of APOS treatment among persons with painful~     knee osteoarthritis affecting the inside (medial or lateral) of their knees. The~     investigators will focus on pain outcomes and quality of life but to better understand how~     and in whom APOS treatment is working, the investigators will also obtain data on loading~     across the knee in the gait laboratory, along with measures of strength and function. In~     addition to the standard pain scales, changes in knee structure on treatment using MRI~     (Magnetic Resonance Imaging) will be analysed to determine whether bone marrow lesions (bone~     bruises) are reduced as these are strongly linked with pain in individuals with medial or~     lateral knee osteoarthritis, and are related to loading of the medial or lateral knee. APOS~     has committed to provide the shoe system and a matched sham device, that they have developed,~     and will also provide the technicians trained to calibrate the pertupods (balls under the~     sole of the foot) on the shoe without charge. The research will be undertaken in a University~     setting for the gait evaluations which has strong links with the Wellcome Trust Clinical~     Research Facility in Manchester for the MRI imaging. Running a randomised controlled trial is~     very labour and time intensive and therefore the team assembled has vast experience of~     carrying out randomised controlled trials of other treatments in knee osteoarthritis, and is~     experienced in both ethical requirements, recruitment and evaluation. The costs requested~     reflect the nature of this research with a large proportion on staff costs and also non-staff~     costs for the MRI imaging and other non-staff costs.~   "
91952|NCT02363556|"~     This randomized controlled trial will use a 2 by 2 factorial design to assess methods of~     cervical preparation prior to Dilation and Evacuations (D&Es) at 14 0/7 to 19 6/7 weeks~     gestational age. In total, 160 woman will be randomized to misoprostol alone or Dilapan with~     misoprostol and separately randomized to buccal or vaginal administration of 400-mcg~     misoprostol. A total of 80 women will receive 400-mcg misoprostol only (40 vaginal and 40~     buccal). Another 80 women will have Dilapan inserted and then use misoprostol (40 vaginal and~     40 buccal). Four to six hours later, the Dilation and Evacuation (D&E) procedure will be~     performed.~   "
91941|NCT02363699|"~     Ineffective treatment of postoperative pain may cause organic damage and chronic pain.~     Nevertheless, opioids, the leading drugs used for this purpose, present side effects that~     sometimes restrict their usability. In a multimodal context, new postoperative analgesia~     techniques have been developed focusing in the reduction of opioid use and their adverse~     effects, as well as postoperative chronic pain prevention. In this background, continuous~     intravenous infusion of lidocaine during perioperative period has shown to be promising. This~     trial aimed to compare postoperative analgesia, opioid consumption, duration of ileus and~     length of hospital stay and IL-1, IL-6, IL-10, α TNF and γ IFN levels in patients undergoing~     to laparoscopic cholecystectomies who received intravenous lidocaine in comparison to a~     control group. Intravenous lidocaine in the perioperative period of laparoscopic~     cholecystectomies was not able to reduce postoperative pain, opioid consumption, and duration~     of ileus or length of hospital stay. However, its anti-inflammatory effect was evidenced by~     the significant changes in the studied cytokines.~   "
91942|NCT02363686|"~     The purpose of this study is to learn more about problems with swallowing that could develop~     in patients who are very sick and need a machine to help them breathe.~   "
91943|NCT02363673|"~     The aim of this study is to determine the effect of individualised homoeopathic treatment of~     children with Autism Spectrum Disorder (ASD).This study is of descriptive case study design,~     with a structured interview and quantitative measurement components taking place over 12~     weeks, with a consultation every 4 weeks. Children aged 3-6 years of age with ASD are invited~     to participate and their parent/guardian is required to be present during each consultation.~     Each consultation will consist of a homoeopathic case taking, conduction of the Childhood~     Autism Rating Scale (CARS) and Autism Treatment Evaluation Checklist (ATEC) measures and a~     brief physical exam. After each consultation, the participant will receive an individualised~     homoeopathic remedy, according to their individual symptoms and characteristics, to take for~     the subsequent 4 weeks. This remedy will be determined using the Mercurius® repertory~     software.~   "
91944|NCT02363660|"~     1. Compare rates of seroconversion and GMTs generated following a 3-dose series of vaccine~          in women given low doses of vaccine by the ID route with the NFI (Group III) to those~          women given standard doses by the IM route with a needle and syringe (Group I) at 1~          month, 6 months and 18 months following completion of the vaccination series.~        2. Compare rates of seroconversion and GMTs generated following a 3-dose series of vaccine~          in women given standard doses of vaccine by the IM route with the NFI (Group II) to~          those women given standard doses by the IM route with a needle and syringe (Group I) at~          1 month, 6 months and 18 months following completion of the vaccination series.~   "
91945|NCT02363647|"~     The Personalized Discovery Process is the only program offering patients treatment~     recommendations based on an empirically constructed Drosophila fly model of their disease.~     Special committee selects one of the one of the few 2-3 FDA approved drug combinations or~     single agents that improved survival in the fly cancer model.~   "
91946|NCT02363634|"~     A randomized double blind placebo controlled trial to evaluate the effects of a specialized~     magnesium on mood states and sleep quality in older adults.~   "
91947|NCT02363621|"~     This study is designed to compare the post injection inflammation and pain seen after~     intravitreal injections of ranibizumab 0.3mg and aflibercept 2.0mg in patients with DME.~      The investigators will be evaluating patients (1-7 days) post injections for:~      1. Intraocular inflammation (defined as anterior chamber and/or vitreous cells 2. Pain (as~     measured on a standardized pain scale).~   "
91948|NCT02363608|"~     The purpose of this study is to describe the effects of canine-assisted activity visits on~     patients and staff in a hospital setting. The Caring Canines program uses dogs who have been~     trained to be obedient, calm and comforting. It involves a visit by a volunteer (called the~     dog's handler) and the volunteer's dog that has been trained and tested to have a good~     personality and to follow commands. A visit typically lasts about 10-15 minutes with the~     patient interacting with the dog while the dog is supervised by the handler. Memorial Sloan~     Kettering currently has Caring Canine dogs visit patients but the investigators don't yet~     know the impact of these visits on patients and staff. The investigators would like to see~     how the Caring Canine visits impact a patients' mood, including anxiety, stress, and sense of~     well-being. Two groups of patients will take part in this study - the first group will~     receive standard post surgery care and will not receive a visit from the Caring Canines~     program and the second group will receive daily visits (Tuesday -Friday) from the Caring~     Canines program while they are on M15. The purpose of this study is to look at differences in~     well-being between patients who have the visits with the dogs and patients who do not.~   "
91949|NCT02363595|"~     The purpose of this study is to identify specific clinical and molecular characteristics that~     are predictive of tumor progression in small thyroid cancers.~   "
91950|NCT02363582|"~     Human milk (HM) is considered the gold standard nutrient for infants, which contains a lot of~     beneficial nutrients such as prebiotics and lactoferrin. Previous studies have shown that~     both prebiotics and lactoferrin play important roles in generating a bifidobacteria-dominated~     colonic microflora.The purpose of this study is to investigate the stool~     characteristics,acceptability, and gastrointestinal tolerance in term infants fed a starting~     infant formula supplemented with prebiotics and lactoferrin.~   "
91951|NCT02363569|"~     This is a prospective study, where the investigators will monitor pregnant women at 4-23~     weeks of pregnancy coming to the Women- E.R. at Meir Hospital due to spontaneous -or~     after intercourse- bleeding or bleeding secretions. The women will fill out questionnaires~     regarding past illness, vaginal bleeding, and gynecologic history. Then they will undergo~     full examination including ultrasound. After discharge, the investigators will recommend to~     all the women who came due to bleeding or bleeding secretions to avoid intercourse for two~     weeks after the bleeding stops. Afterwards they will be monitored until their delivery date~     (filling questionnaires a month after coming to the E.R. and at the end of the pregnancy).~     After they give birth the investigators will assess the rate of pregnancy, obstetric and~     embryonic complications in each of the study groups.~   "
91953|NCT02363543|"~     The purpose of this randomized, comparative study is to determine whether Hyalomatrix is as~     effective as IntegraTM Meshed Bilayer Wound Matrix when used in subjects who receive~     concurrent treatments with both products on their first and/or second degree burns located on~     both hands.~   "
91954|NCT02363530|"~     This randomized controlled subject- and examiner-masked study comprised patients scheduled~     for cataract surgery.The patients will be randomly assigned to receive either balanced salt~     solution（BSS）or hydroxypropyl methylcellulose（HPMC）2% gel （Cornea Protect）.Each subject~     should undertake examination including - rupture time (TBUT), height of the river of tears,~     fluorescence staining, Schirmer Ⅰ test, ocular surface disease index (OSDI) and~     self-conscious symptom assessment questionnaire for assessment.~   "
91955|NCT02363517|"~     This study will investigate the feasibility of treating people who inject drugs (PWID) with~     hepatitis C virus (HCV) in community-based settings with a 12-week course of oral therapy~     combination of sofosbuvir plus ledipasvir. It will also measure the effectiveness of using a~     social network-based approach to reduce HCV incidence among PWID.~   "
91956|NCT02363504|"~     The cause of Alzheimer's disease, the most common form of dementia, remains unknown.~     Neuropathological studies suggest that a small area in the brainstem, the locus coeruleus,~     might be the site of the onset of the disease. This area is the sole source of noradrenalin~     to the brain, a neurotransmitter involved in arousal, but also cognitive functions. Animal~     and pharmacological studies have hinted towards an important role of this area in memory~     functioning. However, these studies were hampered by the limited spatial resolution, making~     it hard to clearly localize the locus coeruleus in the brain. New developments in brain~     imaging allow now to visualize the brain with stunning precision. Furthermore, a non-invasive~     new stimulation method, transcutaneous vagus nerve stimulation, is believed to excite the~     locus coeruleus and thereby influencing neuronal networks and memory functioning.~      There are three aims in this project:~        1. To investigate how the functional interaction between the locus coeruleus and other~          brain areas, in particular the medial temporal lobe areas, during memory processes~          (encoding, consolidation and retrieval) change with development of Alzheimer's disease.~        2. To investigate associations between noradrenaline, memory performance and brain~          functioning. The investigators aim to investigate how acute noradrenalin levels change~          during the different memory processes and whether or not this is beneficial for~          performance. Furthermore, the investigators will investigate whether this interaction~          between noradrenalin, memory performance and brain functioning is different healthy~          older individuals (n =35) or patients with prodromal Alzheimer's disease (n =35).~        3. To investigate the underlying neural network changes during transcutaneous vagus nerve~          stimulation. The investigators will focus on differences in functional connectivity~          between the locus coeruleus and the medial temporal lobe areas in healthy older~          individuals and prodromal Alzheimer's disease patients. An experimental condition will~          be compared with a sham condition in a pseudo-randomized cross-over design.~   "
91957|NCT02363491|"~     The dose-confirming part of this study, comprising at least 10 patients is designed as a~     single center, prospective, single arm, open label in patients who have failed or are~     unresponsive to Azacitidine (AZA) or Decitabine (they may also have additionally failed an~     Erythropoiesis Stimulating Agent (ESA) followed by a dose expansion part with an additional~     30 patients; the objective of the whole study being to assess the safety, efficacy,~     pharmacokinetics and pharmacodynamics of intravenously infused multiple doses of OPN-305 in~     low and intermediate-1 risk myelodysplastic syndrome (Second line Lower risk MDS).~   "
91958|NCT02363478|"~     Esophagus is commonly affected in Systemic Sclerosis (SSc) and esophageal function is~     compromised in about 75% of patients. Previous studies have shown that buspirone, an orally~     available 5-HT1A (serotonin 1a receptor agonist), enhances esophageal motility in healthy~     volunteers. Recently, the investigators observed that a single dose of buspirone (10mg)~     improves lower esophageal sphincter (LES) function in patients with SSc and esophageal~     involvement .~      Objectives: To evaluate the effect of continuous administration of buspirone on esophageal~     dysfunction and related symptoms in SSc using high resolution manometry (HRM).~   "
91959|NCT02363465|"~     To optimize a medical device for intradermal injection, knowledge concerning the thickness of~     epidermis and dermis at the proximal forearm is required. Since scientific knowledge is~     lacking, the investigators will examine the skin thickness (epidermis and dermis) of adults~     using imaging technology (High Frequency Ultrasound). The investigators hypothesize that they~     are able to correlate the thickness of the (epi)dermis to a specific combination of~     parameters age, gender, and BMI.~      Based on these results, the investigators can define which needle type and length is needed~     to correctly perform injections into the dermal layer.~   "
91960|NCT02363452|"~     The purpose of this study is to determine if treatment with reverse transcriptase inhibitors~     returns the interferon signature observed in patients with AGS to normal levels.~   "
91961|NCT02363439|"~     An extension study for patients who complete 24 weeks of IMO-8400 on study 8400-401.~   "
91962|NCT02363426|"~     The purpose of this study is to evaluate intravaginal culture using the medical device~     INVOcell to generate day 5 blastocysts in comparison to traditional IVF.~   "
91963|NCT02363413|"~     The study is based on the assumption that in the Overlap Syndrome, the introduction at home~     of the NIV is as effective in terms of compliance and clinical and gazometric improvement,~     and life quality, that setting hospital start up. The investigators will study the initiation~     of NIV at home versus in hospital in two randomized Overlap Syndrome patient groups. The main~     objective of the study is to demonstrate the non-inferiority of the initiation of the NIV at~     home versus hospital in terms of compliance.~   "
91964|NCT02363400|"~     Nasopharyngeal carcinoma (NPC) is a geographically endemic, Epstein-Barr virus~     (EBV)-associated carcinoma of epidermoid origin. It occurs most commonly in Southern China~     and Southeast Asia. The NPC cells are poorly differentiated or undifferentiated with a high~     incidence of lymphatic and hematological dissemination. Because of the inherent anatomic~     constraints and a high degree of radiosensitivity, radiotherapy (RT) has been the primary~     treatment for NPC patients.~      NPC is also a chemosensitive tumor. Various modes of combined chemoradiotherapy have been~     used to treat NPC patients with advanced-stage diseases during recent 20 years. However,~     treatment outcome for locoregionally advanced NPC is still unsatisfactory.~   "
91965|NCT02363387|"~     The investigators propose to evaluate a novel incentive intervention to promote suppression~     of viral load in people living with HIV that will employ empirically-based parameters that~     have been proven critical to the effectiveness of incentive interventions. Participants (N =~     200) from medical clinics that serve adults living with HIV in Baltimore will be randomly~     assigned to an Incentive or a Usual Care Control group. Incentive group participants will~     receive incentives for maintaining suppressed and undetectable viral loads. The incentive~     program will employ high magnitude incentives, provide incentives for decreases in viral load~     early in treatment before a patient's viral load has reached undetectable levels, arrange~     frequent incentives early in treatment and reduce the frequency of incentives as participants~     achieve progressively longer periods of viral load suppression, arrange a schedule of~     escalating incentives for sustained suppression of viral load, and the intervention will be~     maintained for two years. Usual Care Control participants will only receive the standard HIV~     medical care offered in their clinic. Assessments will be conducted every 3 months throughout~     the two years of treatment and every 6 months throughout the year following treatment. The~     primary outcome measure will be the percentage of participants that have undetectable viral~     loads at the 3-month assessments conducted throughout the 2-year intervention period.~     Secondary measures will include adherence to HIV care and post-treatment outcomes. The~     investigators will also assess moderators and mediators of the effects of the incentives on~     the suppression of viral load, and conduct cost-effectiveness and cost-benefit analyses. If~     the incentive intervention maintains suppressed viral load and is economically sound, it~     could be used to improve the health of adults living with HIV, reduce health care costs, and~     reduce HIV transmission in the community.~   "
91966|NCT02363374|"~     Preoperative 5-FU-based (5-fluorouracil) chemoradiotherapy (CRT), total mesorectal excision~     surgery, and 4 cycles of adjuvant 5-FU - as established by CAO/ARO/AIO-94 - is at present a~     standard of care for patients with locally advanced rectal cancer (UICC stage II and III).~     The phase III German CAO/ARO/AIO-04 trial showed, that the addition of oxaliplatin increased~     treatment efficacy in terms of early secondary efficacy endpoints (e.g. the pCR-rate). With a~     median follow-up of 50 months, the primary endpoint of this trial - disease free survival -~     was significantly improved in the oxaliplatin-containing treatment arm (3-year disease-free~     survival (DFS) 71.2% versus 75.9%, hazard ratio (HR) 0.79, 95% confidence interval (CI)~     0.64-0.98, p=0.03). The hereby proposed randomized phase II trial CAO/ARO/AIO-12 aims at~     finding novel and innovative aspects of rectal cancer treatment, and will thus provide~     important information for defining the experimental arm in the upcoming large scale trial of~     the group. Compared to the current standard, in both study arms, the sequence of the three~     treatment modalities is modified, placing the chemotherapy block before surgery. The~     pre-operative sequence of chemotherapy -> chemoradiotherapy (arm A) has been shown to be~     feasible with no early tumor progression prior to definitive surgical resection in a small~     randomized phase II study from Spain. The sequence chemoradiotherapy -> chemotherapy (arm B)~     may be beneficial according to response kinetics considerations, and by maintaining a highly~     effective local treatment in the first place. Both approaches could avoid the problem of~     major compliance problems with post-operative adjuvant chemotherapy. CAO/ARO/AIO: German~     Rectal Cancer Study Group~   "
91967|NCT02363361|"~     This is a phase II, single center, open-label, non randomized clinical study to assess the~     uptake, safety and tolerability of Imatinib in acute Cervical Spinal Cord Injury patients.~     The aim is to determine if Imatinib reaches sufficient blood levels when given to patients~     with cervical spinal cord injury, via a gastric feeding tube, and also evaluate the safety~     and tolerability of this drug treatment.~   "
91968|NCT02363348|"~     Randomized double-blind controled clinical trial to assess the efficacy and safety of~     L-arginine to prevent preeclampsia.~      applied to pregnant women with risk factors for preeclampsia. the main result was the~     development of preeclampsia as well as side effects to taking l arginine besides perinatal~     outcomes~   "
91969|NCT02363335|"~     Background:~      The drug Roflumilast (Daliresp) is used to treat Chronic Obstructive Pulmonary Disease~     (COPD). COPD is a lung disease that makes it difficult to breathe. Studies have shown that~     this drug decreased the blood sugar of people with type 2 diabetes. Sitagliptin (Januvia) is~     a medication presently used to treat diabetes. Researchers think that both of these drugs may~     decrease blood sugar by causing an increase in the hormone GLP-1.This hormone is secreted in~     the small intestines and stomach and is also known as an incretin. Researchers want to study~     how these drugs affect blood sugar, insulin, and other hormones in the blood.~      Objectives:~        -  To study the effects of Roflumilast (Daliresp) and Sitagliptin (Januvia) on blood sugar~          and insulin.~        -  To better understand GLP-1 and other gut hormones. This may lead to new treatments for~          type 2 diabetes.~      Eligibility:~        -  Healthy volunteers age 21 55.~        -  Body Mass Index (BMI) less than 30~      Design:~      -This study will require one screening visit and four study visits, scheduled about 3-weeks~     apart.~      Screening visit requires participants to arrive after fasting for 10 hours and have the~     following:~        -  Medical history, physical exam, height, weight, blood pressure measurements and blood~          and urine tests.~        -  A 2-hour oral glucose tolerance test (OGTT). Participants will drink an orange-flavored~          drink containing 75 grams of sugar (300 calories). A blood sample will be taken prior to~          drinking the beverage and 2-hours later.~        -  An electrocardiogram (EKG) to measure the electrical activity of the heart.~        -  Questionnaires about risk for depression or suicide.~      Study visits 1to 4:~        -  Participants will arrive the evening prior and blood work will be done to confirm~          eligibility. They will not eat or drink anything except water starting at 8:00 p.m.~        -  About 6:30 a.m. the following day, an I.V. (small plastic tube) will be placed in an arm~          vein and used to take 20 blood samples over a period of about 11 hours.~        -  Participants will receive one of the following study medication/placebo groupings in~          random order:~             1. Roflumilast (Daliresp) 500 mcg pill; and 1 placebo pill~             2. Sitaglipitin (Januvia) 100 mg pill; and 1 placebo pill~             3. Roflumilast (Daliresp) 500 mcg pill; and Sitagliptin (Januvia) 100 mg pill~             4. 2 placebo pills~        -  One hour later, they will have a 10-hour mixed meal test (MMT). They will be asked to~          drink a nutritional shake (Ensure Plus). Blood samples will be taken over the next 10~          hours to measure blood sugar, insulin and other hormones. At the end of the test, they~          will be given a meal.~        -  Participants will answer questions about side effects and symptoms. They will receive a~          follow-up phone call within 10 days.~   "
91970|NCT02363322|"~     Background:~      - Ebola is a viral infection that can spread quickly and causes life-threatening disease.~     Right now there is an Ebola outbreak in many countries in West Africa. There are no approved~     treatments for Ebola. But possible treatments are being developed. Researchers need to study~     these treatments to see if they help people get better.~      Objective:~      - To identify possible Ebola treatments. Also, to learn if adding 1 or more experimental~     drugs to advanced Ebola care can reduce the risk of death.~      Eligibility:~      - People who have recently been diagnosed with Ebola, usually by a test called the Polymerase~     Chain Reaction (PCR), and have been hospitalized in an isolation unit for treatment.~      Design:~        -  Participants will be randomly assigned to Group A or B. Both groups will get advanced~          level care. One group will also get an experimental drug.~        -  Participants may have blood tests. They may have another PCR test.~        -  Researchers will try to learn how the participant got Ebola.~        -  Participants put in the experimental drug group may start taking medicine within 24~          hours of enrollment. It may be given by mouth or intravenously. Additional doses may be~          needed.~        -  Participants may have a series of timed blood tests over the first 24 to 48 hours after~          they take the medicine.~        -  Blood will be drawn frequently. Other body fluids (urine, stool, vaginal fluid, etc.)~          may also be collected.~        -  Participants will be followed for up to 60 days. They may be evaluated for any long-term~          effects of the experimental treatment(s). They may be asked to return for 1 or more~          outpatient visits.~        -  For consenting participants, follow-up will be extended for up to one full year past Day~          58 with contact/visits every 1-3 months to assess for a history of signs or symptoms~          potentially consistent with late onset of virologic relapse syndrome.~   "
91971|NCT02363309|"~     Background:~      - Non-alcoholic fatty liver disease (NAFLD) is a common cause of abnormal liver tests. It is~     closely linked to health problems like obesity and diabetes. Researchers want to use a breath~     test to measure the metabolism of fatty acids and learn more about the causes of disease.~     They will compare the results between people who do and do not have NAFLD. They will also~     repeat the test in people with NAFLD after treatment to see improvement.~      Objectives:~      - To measure the metabolism of fatty acids and compare them between people who do and do not~     have NAFLD, and people with NAFLD before and after treatment.~      Eligibility:~        -  People age 21 and older with NAFLD~        -  Healthy volunteers~        -  non-NAFLD metabolic syndrome~      Design:~        -  Participants will be screened with medical history, physical exam, and fasting blood~          tests.~        -  Participants will fast overnight.~        -  Participants will sit in a comfortable chair. They will relax for 15 minutes. Then a~          narrow plastic tube will be put under their nostrils. It will be connected to a breath~          test device.~        -  Participants will drink palmitate or acetate in a heated liquid meal (Ensure). Palmitate~          is a fatty acid and acetate is a small molecule that is a building block for fatty~          acids. Both palmitate and acetate are natural compounds that are in our body and our~          food.~        -  Participants will sit for 6 hours. They can read, watch television, work on a computer,~          or other relaxed activity. The air they breathe out from their nose will be collected~          and analyzed. They may take a bathroom break after 3 hours. They may drink water after 3~          hours.~        -  Participants will get a meal after the test.~        -  Participants will have another visit at least 1 week later. They will repeat the test~          with the other compound (acetate of palmitate).~        -  Participants may be asked to repeat a test to study the result of a change like weight~          loss or medicine. Thus, participation can last from 1 week to several years.~   "
91991|NCT02363049|"~     The present study is a multicentric randomized phase III trial designed to assess whether~     overall survival and quality of life are improved in patients with asymptomatic colon cancer~     and unresectable SLM treated with resection of the PT followed by chemotherapy versus~     chemotherapy alone.~   "
91992|NCT02363036|"~     Accumulating evidence suggest that the proliferative, invasive, and immune tolerance~     mechanisms that malignant tumors use to establish a nutrient supply and evade or edit the~     host immune response are similar to those used by the developing placenta during normal~     pregnancy. In addition to the shared capacity for invading through normal tissues, both~     cancer cells and cells of the developing placenta create a microenvironment supportive of~     both immunologic privilege and angiogenesis.~      CD11b+Gr1+ cells are a heterogeneous population of bone marrow-derived cells (BMDC) that~     consist of immature myeloid cells (IMCs), and were first described as myeloid-derived~     suppressor cells. In healthy individuals, IMCs that are generated in the bone marrow~     differentiate into mature granulocytes, macrophages, or dendritic cells (DCs). These cells~     have been shown to play an essential role in mediating immune suppression in animal models of~     human tumors. As a result of tumor-induced alterations in myelopoiesis, IMCs have been found~     in peripheral blood, lymphoid organs and the tumor tissue itself. An increased population of~     IMCs was identified in patients with several tumor types. Accordingly, IMCs detected in the~     peripheral blood of such patients bearing express the common myeloid marker CD33 but lack~     markers of mature myeloid cells such as the MHC class II molecule HLADR.~      IMCs have been shown to actively promote tumor growth and metastasis by modulating the~     cytokine environment, and through vascular remodeling by promoting angiogenesis.~      It has been demonstrated in our laboratory that IMCs infiltrate placentas of pregnant mice~     and actively promote angiogenesis. These cells show striking similarity to IMCs that populate~     malignant tumors. Accordingly, human placentas are also infiltrated by a significant~     population of IMCs. Immunostaining of human placentas showed that IMCs comprise around 25% (~     range 10-40%) of total placental CD45+ bone marrow-derived hematopoietic cells and that this~     population is located close to blood capillaries. We also demonstrated that immature DCs,~     cells originally described to regulate the adaptive immune response, also promote~     angiogenesis in models of choroidal neovascularization, endometriosis and tumors.~      This is a retrospective study on patient's blood samples of pregnant women who came to~     delivery in our department during 1.1.2014-31.12.2014, to compare the abundance of monocytes~     and neutrophils in: 1. Term active labor. 2. Elective cesarean section.~      According to our previous findings, we hypothesize that monocytes in active delivery will be~     lower than in women without signs for labor. We also hypothesize that neutrophils will be~     more abundant in active delivery than in women without signs for labor.~      We plan to screen anonymous electronic data of women who delivered in our departement during~     2014 according to the following eligible criteria, stratified into 2 categories: 1. Women who~     were admitted in active labor. 2. Women who were admitted for elective Cesarean Section~     without signs of labor.~      We will compare the abundance of monocytes and neutrophils in blood counts that were taken on~     admission day between the two populations.~   "
91972|NCT02363296|"~     Background:~      - Brain activity changes with changes in body temperature. Brain activity can be studied with~     a procedure called transcranial magnetic stimulation (TMS). Researchers want to cool the~     brain through the scalp using a cooling cap. They want to see if cooling changes the brain~     and body s response to TMS.~      Objectives:~      - To look at the effects of cooling on the brain.~      Eligibility:~      - Right-handed adults age 18-50 who can abstain from caffeine and tobacco.~      Design:~        -  Participants will be screened with medical history and physical exam. They will be asked~          about alcohol use, smoking, and substance abuse. They may take a pregnancy test. They~          may have a magnetic resonance imaging (MRI) scan of the brain. For MRI, participants lie~          on a table that slides in and out of a metal tube that takes pictures.~        -  Participants will have 3 outpatient visits. The following procedures will occur at each~          visit.~        -  Participants will wear a cooling cap for up to 45 minutes. Cool water will flow through~          the cap. It will feel like an ice pack in a towel. Their core temperature will be~          monitored. Their temperature will also be measured under their tongue and on scalp,~          stomach, forearm, and calf.~        -  Participants will have TMS before and after wearing the cap. A brief electrical current~          will pass through a wire coil held on their scalp. Electrodes that detect muscle~          movement will be placed on their hand. They will also have repetitive TMS, which uses~          repeated magnetic pulses. Their wrist will also receive a shock.~   "
91973|NCT02363283|"~     This phase II trial studies how well glembatumumab vedotin works in treating patients with~     middle layer of the wall of the eye (uveal) melanoma that has spread to other parts of the~     body (metastatic) or has returned at or near the same place after a period of time during~     which the cancer could not be detected (locally recurrent). Glembatumumab vedotin may shrink~     the tumor by binding to tumor cells and delivering tumor-killing substances to them.~   "
91974|NCT02363270|"~     Our previous published research comparing the efficacy of intravenous ketamine to morphine~     has shown ketamine to provide equivalent relief of moderate to severe acute pain in emergency~     medicine patients. Secondary analysis of the previous published research has also revealed~     ketamine to have statistically more side effects. The investigators believe that increasing~     the time of administration of the ketamine, from a push injection to a drip infusion, will~     minimize the side effects experienced by recipients of ketamine.~   "
91975|NCT02363257|"~     Three years since the Smoke Free Mumbai campaign and six years since the ban on smoking in~     public places was implemented. It is necessary to review the situation at this point in time~     so that corrective actions if necessary can be taken. Hence, this study is planned to~     understand the perceptions and attitudes of commuters and bus employees (drivers, conductors~     and ticket checkers) regarding the law, its implementation, reactions from the commuters,~     violations observed, violations reported.~      This study will help evaluate the implementation of provision of prohibiting smoking in~     public places and help understand how to increase the compliance. The results will inform~     enforcement and public health agencies about where to target enforcement and public education~     resources.~   "
91976|NCT02363244|"~     This is a pilot study to assess the cell adequacy and quality of Pap smears and adequacy of~     samples for HPV DNA virus test done after application of 5%acetic acid in a VIA test.Normally~     a Pap test and HPV DNA test is performed before application of acetic acid. It is assumed~     that application of acetic acid may alter the cell adequacy of Pap test and HPV DNA test, if~     any of the above tests is done immediately after VIA test.The present study aims to see the~     effect of 4-5% acetic acid [vinegar] on the cell adequacy and quality of Pap smear and sample~     adequacy for HPV DNA test.~   "
91977|NCT02363231|"~     The process of weaning from mechanical ventilation was decided after clinical judgment and~     weaning predictive index. Nevertheless, indexes predicting weaning outcome like Maximal~     Inspiratory Pressure (MIP) are frequently inaccurate. However the long-term involvement of~     respiratory muscles in critically ill patients has not been established. The objective of~     this study was to assess the relationship on MIP at extubation on one-year mortality in~     critically ill patients.~   "
91978|NCT02363218|"~     Study Phase: multi-institutional Phase II study Primary Objective(s): To determine overall~     survival for HCC patients treated with CyberKnife SBRT at 2 years.~      Secondary Objective(s): 1) To determine overall survival for HCC patients treated with~     CyberKnife SBRT at 1 year 2) To determine local control using RECIST and EASL criteria at 1~     and 2 years 3) To assess progression-free survival at 1 and 2 years 4) To assess acute and~     late toxicities following CyberKnife SBRT.~      Hypothesis: Overall survival rate of HCC patients at one year after SBRT treatment is not~     less than 65%.~      Study Design: Single arm study. Patients will undergo a CT scan with and without contrast and~     MRI scan for radiation treatment planning and target delineation.SBRT will be delivered on~     the CyberKnife with Synchrony Respiratory Tracking capabilities. The tumor will be tracked~     with 3 implanted fiducial seeds for targeting. Treatment will be delivered in 3 fractions~     within a 7 day window at the discretion of the investigator.~      Sample size: The sample size required is 93 with a power of 90%, p=0.05, 50% response rate is~     considered not effective (p0) and 65% overall survival rate at 1 year (p1) is considered~     effectiveness of the treatment. The estimated drop-out rate is 20%, so the total sample size~     would be 117.~      Statistical Considerations: The set of Intention-To-Treat (ITT) will be analyzed. All~     patients will be censored at their last visit, including the patients lost to follow-up. All~     patients will be followed and counted in the therapy to which they were assigned, even if~     they decline that therapy. Only those patients who refuse (in writing) to have their outcomes~     count in the study's conclusions will not be included in the analyses from that time forward;~     however, the follow-up data for such patients will be included up until the time they~     withdraw consent. Such patients will be replaced.~      Baseline characteristics of patients will be presented with summary statistics. Time-to-event~     survival rates for OS and DFS will be estimated using the Kaplan-Meier method and presented~     at one and/or two years. The incidence of acute and late toxicities will be presented in~     tabular form on both a per-patient and per-event basis.~   "
91979|NCT02363205|"~     The purpose of this study is to determine whether tailored internet-administrated cognitive~     behaviour therapy (CBT) is a feasible approach in the treatment of depressive symptoms and~     comorbid anxiety symptoms.~   "
91993|NCT02363023|"~     The study is designed to evaluate sensitivity, specificity and accuracy of non-bronchoscopic~     bronchoalveolar lavage and endotracheal aspirate in comparison with bronchoscopic~     bronchoalveolar lavage (gold standard), as methods for etiologic diagnosis of ventilator~     associated pneumonia and their impact in morbimortality.~   "
91994|NCT02363010|"~     The major goal of this project is to evaluate an innovative approach to obesity. This study~     will determine if behavioral treatment can be improved by 1) implementing a primary focus on~     PA following initial weight loss treatment, and 2) using a novel, acceptance-based approach~     to the promotion of PA.~   "
91995|NCT02362997|"~     This phase II study is designed to determine the clinical efficacy of PD-1 blockade, using~     the anti-PD-1 monoclonal antibody pembrolizumab (MK-3475), administered as consolidation~     therapy after autologous stem cell transplant (ASCT), in patients with relapsed or refractory~     (R/R) Diffuse Large B Cell Lymphoma (DLBCL), classical Hodgkin Lymphoma (cHL) or peripheral~     T-cell lymphoma (PTCL) in 1st remission.~   "
91980|NCT02363192|"~     Of the 5.2 million people with asthma in the UK, approximately one in every 40 have severe~     asthma that needs the maximum available treatments advised in national asthma guidelines~     (known as the 'British Thoracic Society / Scottish Intercollegiate Guidelines Network British~     Guideline on the Management of Asthma'). Despite this, asthma is still inadequately~     controlled in about half of these patients and they are classed as having 'difficult asthma'.~     There maybe potential for improvement of the care and health of these patients through better~     use of medicines and greater input from pharmacists, but more research is needed.~      The aim of the study is to measure the effects over six months of coordinated information and~     advice about medicines from hospital and community pharmacists on asthma control in patients~     with difficult asthma. The patients in the study (52 in total) will be recruited from adult~     patients attending a specialist difficult asthma clinic in a hospital.~      Patients will be randomly chosen to have either an appointment with the specialist pharmacist~     (intervention group), or usual medical care (control group). Usual care will involve seeing~     the Consultant or Specialist Registrar (doctor) in the clinic. Patients in the intervention~     group will receive i) assessment and education on asthma, and review of their inhaler~     technique, from a hospital Advanced Clinical Pharmacist and ii) will also be referred for a~     medicines use review from their usual community pharmacist (chemist), to take place 1-2~     months after their hospital clinic appointment. The Advanced Clinical Pharmacist will be~     working closely with the Consultant.~      Results will be measured using methods that have been developed by experts in asthma and~     tested in previous research. Asthma control will be measured using Juniper's Asthma Control~     Questionnaire. Other measurements will cover quality of life, use of medication, use of~     healthcare resources, and inhaler technique.~   "
91981|NCT02363179|"~     The investigators will conduct a prospective quasi-experimental design study of patients in~     the University of Florida Health Emergency Department. Live preferential music will be~     performed for patients in the emergency department on alternating days over 20 weeks, and~     subjects exposed to the music intervention will be matched to a cohort that present to the~     emergency department on days with no music to assess impact on patient and healthcare~     provider satisfaction, pain medication utilization, length of stay, and cost of care.~   "
91982|NCT02363166|"~     Given that the Emergency Department (ED) has become the entry way for large populations of~     patients into the health care system, a strategy of sampling MRSA isolates in ED populations~     and merging this information with patient-level data may present a window to hypothesize and~     investigate CA-MRSA transmission within the community and its impact on hospital-acquired~     infections.~   "
91983|NCT02363153|"~     This study examines the effects of individualized diet and exercise plans on muscle strength,~     quality of life and respiratory function in Pompe disease. Subjects will be given a diet and~     exercise plan based on their individual needs, which will be followed for 16 weeks.~     Participants will also be provided with an activity tracker in order to track their exercise~     activities, access to an app that will allow them to input their daily food intake, and they~     will also come to the University of Florida for exercise tests, respiratory tests and~     questionnaires.~   "
91984|NCT02363140|"~     The menisci in the knee joint are important for normal functioning of the knee. Meniscus~     tears are amongst the commonest of injuries to the knee. The pattern and blood supply of the~     meniscus tears determines the treatment plan and outcome. The surgeon identifies the blood~     supply to the meniscus tear area during the arthroscopy(key hole operation) and decides the~     treatment option ie repair versus partial meniscectomy.~      This study aims to identify any changes that occur in the meniscus blood supply. The~     following are the main aims of the 'MOVE'study-~        1. Use of non-invasive methods ie MRImaging to assess meniscus vascularity to~          preoperatively plan treatment and advice patient on recovery.~        2. The study would assess changes in meniscus blood supply depending on age of the patient.~        3. The study aims to assess the alteration in meniscus blood supply following an~          arthroscopic(key hole) meniscal repair operation.~   "
91985|NCT02363127|"~     Randomised, prospective, investigator-blinded, controlled, single-centre study to assess the~     impact on the ongoing pregnancy rate with the use of two progesterones with different~     administration routes, in recipients of fresh embryos from donor oocytes, undergoing~     endometrial preparation for fresh embryo transfer.~   "
91986|NCT02363114|"~     The primary objective of this study is to determine whether baseline DOC screening can add to~     clinical and demographic data to predict the occurrence of a composite negative outcome (any~     of: recurrent stroke, myocardial infarction, death, or admission to a long-term care (LTC) /~     complex continuing care (CCC) facility) within one year of screening, in stroke prevention~     clinic patients.~   "
91987|NCT02363101|"~     The purpose of this study is to evaluate the costs, health-related quality of life and~     preference values from lung cancer patients assisted in a Brazilian public health care unit.~   "
91988|NCT02363088|"~     Cervical cancer is the most common cancer in women under 35 years and is a major public~     health concern. Fortunately, the natural history of this malignancy can be beneficially~     improved through cytological screening. However, the success of screening programmes depends~     on their ability to attract the at risk population, as well as the analytical sensitivity~     and specificity of the screening test. In the UK, screening consistently falls short of the~     80% national target and recent evidence shows uptake is decreasing, in part due to the~     introduction of HPV vaccination programmes. In the under 30s London population, average~     coverage only reached 50% in 2013. Given this information, the cervical screening programme~     is under increasing pressure to improve uptake, and need an evidence based intervention.~      We aim to improve the uptake of cervical screening using SMS messaging through a randomised~     controlled trial. The trail will evaluate both the prevalent and incident rounds of screening~     and within the intervention group, analyse how the content of text reminders influences their~     effectiveness. Specifically we will evaluate a) neutral b) messenger c) social norms d)~     framed gain/loss reminders. Unlike our previous trial, this SMS reminder will encourage the~     booking of an appointment which has never been tested, rather than simply reminding women to~     attend. All women being invited for cervical screening, registered at participating GPs~     within Hillingdon will be eligible to participate. Women will also be provided with a 2 week~     window during which they can opt out of the research. Given the sample sizes we predict the~     trial will take 9 months.~   "
91989|NCT02363075|"~     The main purpose of this study is to estimate the efficiency at 3 months of dexamfetamine~     sulphate on the MFI 20 scale in severe fatigue of patients with stabilized gliomas.~   "
91990|NCT02363062|"~     The major objective of the project is to map/identify new loci/genes, by a combination of~     whole exome sequencing and genome-wide linkage in autosomal dominant FTLD families excluded~     for known mutations.~      Several secondary goals will be attained in the course of during the project:~      For each novel gene identified in this project, we will determine the spectrum of mutations,~     evaluate their frequency and characterize the associated phenotypes. This will allow us to~     establish genotype-phenotype correlations in a large number of families, which will improve~     the nosology of these disorders and the diagnostic procedures;~   "
91997|NCT02362971|"~     The aim of this study is to evaluate the external validity of a randomized controlled trial~     comparing choice of hip arthroplasty for elderly patients (>80 years) with a displaced~     femoral neck fracture.~      The hypotheses are that patient reported hip function, quality of life are better and~     healthier in those included in the randomized controlled trial than those excluded. The~     external validity of the randomized controlled trial is acceptable.~      A prospective randomized controlled trial is planned and patients with a displaced femoral~     neck fracture will be included and randomized between either a hemiarthroplasty or total hip~     arthroplasty. All patients screened will be included in a prospective cohort study for~     evaluation of the external validity of the randomized controlled trial. The prospective~     cohort study will consist of 3 different groups.~      Patients included in the randomized controlled trial will form group 1. Patients eligible for~     the randomized controlled trial but did not give their informed consent and therefore~     excluded, form group 2.~      Patients with a femoral neck fracture which by any reason were excluded form group 3.~      Primary endpoint is patient-reported hip function (Harris hip score) and pain on the operated~     extremity evaluated with VAS (Visual Analogue Scale) and patient reported quality of life~     evaluated with EuroQol (EQ-5D). Secondary outcome measurement are the frequency of the~     complications, periprosthetic fracture, dislocation, revision surgery due to wound infection~     (deep and superficial) and loosening of the components. Baseline data, age, sex, comorbidity,~     cognitive status, weight, height, motor function, complications and reoperations. Follow up~     is performed 1-2 years after surgery.~      Group 1 is followed up in the ongoing randomized controlled trial by visits to the orthopedic~     department at Danderyd Hospital. Group 2 and 3 are followed up by telephone interview 1-2~     year after surgery.~   "
91998|NCT02362958|"~     Evaluating the Efficacy of Lapatinib in Combination With Chemotherapy in Patients With~     Trastuzumab-refractory Metastatic HER2-positive Breast Cancer.~   "
91999|NCT02362945|"~     Post-Partum Hemorrhage (PPH) is a common obstetrical complication. It may occur after both~     vaginal and cesarean delivery with a reported prevalence of 4-6% of deliveries [1].~     Prophylactic treatment with oxytocin after fetus extraction is a common practice.~     [1,2]Transexamic acid - Hexakapron is a potent antifibrinolytic, it prevents lysine adhesion~     to plasminogen molecules by blocking its binding site. It can lower fibrinolysis rate and by~     that reduce bleeding [9]. Systematic treatment of anti-fibrinolytic drugs is in surgical~     practice after procedures such as coronary artery bypass graft, orthopedic surgeries and~     liver transplantation [10-13]. Hexakapron is an FDA approved drug, it is defined as a class B~     drug for pregnancy and lactation [12], it is already being used in a non-routine fashion in~     the delivery room during PPH.In obstetrics Hexakapron given before vaginal or cesarean~     delivery has been presumed to decrease blood loss and PPH. 2 studies that included 453 woman~     reported decrease in PPH (RR 0.51, 95% CI 0.36 to 0.72) [13-15]. However specific protocols~     for prophylactic treatment with Hexakapron as available with oxytocin are lacking, and~     further research is necessary to determine such guidelines [16].~   "
92000|NCT02362932|"~     The purpose of this study is to determine the health impact of a basic sanitation~     intervention in Maputo, Mozambique.~   "
92001|NCT02362919|"~     The aims of the study are to a) identify individuals with a poor response to influenza~     vaccination and b) identify factors associated with a poor response to influenza vaccination.~   "
92002|NCT02362906|"~     The purpose of this study is to evaluate the effectiveness of traditional Chinese medicine~     for treatment of pediatric pneumonia. It is a multicenter randomized controlled trial.~   "
92003|NCT02362893|"~     The purpose of the study is to access the change in mean daytime systolic blood pressure in~     participants with essential hypertension not adequately controlled (defined as mean systolic~     daytime ambulatory blood pressure ≥ 135 mmHg) and randomly assigned to either an intervention~     group with one-time only Direct Observed Therapy (DOT) immediately followed by ABPM or a~     control group with standard ABPM.~   "
92004|NCT02362880|"~     The main purpose of the study is to assess safety of a single dose of FBB followed by PET~     scan in individuals at risk of genetic Alzheimer's disease.~   "
92005|NCT02362867|"~     The protocol will define the clinical study for Ortho Development's Balanced Knee® System~     (BKS) for subsequent review and approval by an Institutional Review Board (IRB).This clinical~     study will compare the clinical outcomes of BKS to currently marketed devices.~   "
92006|NCT02362854|"~     The aim of this study was to compare the efficacy of a diode laser (DL) as an adjunct to~     conventional scaling in the treatment of mild-to-moderate peri-implantitis. A prospective~     clinical, radiographic and microbiologic split-mouth study was conducted to test the~     following null hypothesis; adjunct application of a diode laser, in the conventional~     treatment of peri-implantitis, are not associated with a statistically significant difference~     regarding the microbial counts, marginal bone loss and peri-implant parameters.~   "
92007|NCT02362841|"~     There are no available criteria for determining the optimal flow rate and mean arterial~     pressure level in patients under cardiopulmonary bypass (CPB). Transcutaneous carbon dioxide~     tension (PtCO2) has been proposed for microcirculation monitoring and it could be useful for~     guiding hemodynamic optimization under CPB. The goal of this exploratory study was to~     determine the factors that influence PtCO2 variations during CPB.~      DESIGN: Cutaneous ear lobe CO2 tension was monitored along with hemodynamic parameters every~     10 minutes during CPB, until aortic unclamping. SETTING: French university teaching hospital~     PARTICIPANTS: Patients scheduled for cardiac surgery requiring CPB were prospectively~     included.~   "
92008|NCT02362828|"~     The aims of EPiMAP Obstetrics are:~        -  to identify risk factors for failure of epidural blood patch in the obstetric population~          for management of post dural puncture headache.~        -  to describe European practices in the management of accidental dural puncture in the~          Obstetric population.~   "
92009|NCT02362815|"~     We designed a two arms prospective, randomised, simple blinded trial to compare the impact of~     clear liquid intake on gastric content before delivery. We hypothesize that there will be no~     difference between the two groups, leading to safety of clear liquid intake during labour.~   "
92010|NCT02362802|"~     This study aims to investigate the impact of antitachycardia pacing ( ATP) on the myocardial~     tissue with respect to its potential micro damage measured by several myocardial markers,~     especially by high-sensitive TroponinT.~   "
92011|NCT02362789|"~     The study is designed to explore the kinetics of psoriasis symptoms, pruritus intensity and~     lesional biomarkers during 16 weeks of treatment with 300 mg secukinumab in patients with~     moderate to severe psoriasis and a high pruritus involvement at baseline. For patients who~     achieve extensive remission defined as a PASI response of 98-100%, the kinetics of psoriasis~     and pruritus symptoms will be further explored during a randomized withdrawal phase of 16~     weeks. Biopsies will be taken to investigate lesional biomarkers related to the pathogenesis~     of pruritus in psoriasis patients.~   "
92012|NCT02362776|"~     This study aims to determine whether metabolic changes occur in blood plasma of cancer~     patients, and whether these changes can be used as a biomarker to detect cancer. These~     analyses will be done by means of nuclear magnetic resonance (NMR) spectroscopy.~   "
92014|NCT02362750|"~     The Evaluating Cancer Survivorship Care Models project is an innovative 3-year study that is~     collecting data to help understand how to best deliver follow-up care to cancer survivors.~     Cancer is a complex disease requiring complex treatments that can cause lasting impacts after~     treatment ends. Some patients face physical, psychosocial, spiritual and/or practical~     challenges as they adjust to life after cancer. Fortunately, health care providers have begun~     to focus on the consequences of cancer and its treatment and are more actively working with~     cancer survivors to manage post-treatment needs and care.~      Led by the George Washington University and funded by the Patient-Centered Outcomes Research~     Institute, this project brings together representatives from the Commission on Cancer, the~     Cancer Support Community, LIVESTRONG and the American Cancer Society as well as cancer~     survivors and healthcare professionals to better understand how different strategies or~     models of care impact outcomes that are most important to cancer survivors. The project will~     focus on survivors of breast, prostate and colorectal cancers and will be relevant for~     understanding the needs and preferences of survivors of other cancers as well. The emphasis~     is on patient-centered outcomes, which are outcomes that are most significant to patients,~     such as patient satisfaction and quality of life.~   "
92015|NCT02362737|"~     This study will test ways to improve health behaviors using an intervention that has been~     specially designed for African-American men. The program, called Active & Healthy Brotherhood~     (AHB), will provide information on basic health, and healthy eating, physical activity,~     stress management, and how to get medical care when needed.The AHB intervention will be~     compared to a control group that will receive basic health information in videos and~     brochures.~   "
92016|NCT02362711|"~     The purpose of this long-term study is to determine whether NPC-16 is effective in the~     treatment of dysmenorrhea.~   "
92017|NCT02362698|"~     this research adopted multicentered, randomly and parallel control methods to observe the~     clinical effects of electro-acupuncture combined psychological intervention on internet~     addiction disorder, aim to provide a convenient, affordable and effective clinical protocol.~   "
92018|NCT02362685|"~     Exertional symptoms are the hallmarks of metabolic myopathies, supporting the concept of~     using functional tests when this diagnosis is suspected. Exercise increases the concentration~     of muscle metabolites in the venous blood supply (e.g. lactate, pyruvate, and ammonia)~     especially during recovery. The purpose of this study is to compare the results of exercise~     testing with to the data from muscle biopsy or genetic analysis.~   "
92019|NCT02362672|"~     The purpose of this study is to determine whether a new opioid molecule, NKTR-181, is~     effective for the relief of moderate to severe chronic low back pain as compared to a~     placebo.~   "
92020|NCT02362659|"~     The purpose of this observational registry is to compare the safety and efficacy of an~     antithrombotic regimen comprising one single antiplatelet agent plus an oral anti-thrombotic~     versus those consisting of DAPT alone or DAPT plus oral antithrombotic therapy. This registry~     will assess whether the antithrombotic therapy intensity will vary positively with physician~     perceived ischemic risk at the time of percutaneous coronary intervention (PCI), and whether~     an inverse association will be observed with perceived bleeding risk.~      This study will also evaluate the physician use of objective benefit-risk assessment scores~     and their influence on prescription of antithrombotic therapy in atrial fibrillation (AF)~     patients undergoing PCI. Additionally the study will investigate whether patient perceived~     relevance and accessibility of anti-platelet and anticoagulant treatment regiments will~     predict treatment adherence and whether non-adherence will independently influence outcome.~      Approximately 2500 subjects with non-valvular AF undergoing all-comer PCI with stenting will~     be enrolled in North America and Europe, sites to be determined. Follow-up will be done via~     telephone by trained research coordinators at each participating site at 30 days, 6 months~     and 12 months.~   "
92021|NCT02362646|"~     The main purpose of this research is to determine whether injecting mesenchymal precursor~     cells (MPC) into the heart during surgery to implant a left ventricular assist device (LVAD)~     is safe. MPCs are normally present in human bone marrow and have been shown to increase the~     development of blood vessels and new heart muscle cells in the heart. In addition, this~     research is being done to test whether injecting the MPCs into the heart is effective in~     improving heart function.~   "
92022|NCT02362633|"~     The purpose of this study is to investigate the long-term effect of Transcranial Direct~     Current Stimulation (tDCS) on appetite control related brain regions.~   "
92023|NCT02362620|"~     PROSTAC is a prospective multi-centre study to analyse circulating and tissue biomarkers that~     may predict prognosis and response in patients with CRPC treated with Docetaxel or~     Cabazitaxel.~   "
92024|NCT02362607|"~     The investigators aim to assess whether using integrated diabetes management protocol using~     smartphone would increase glucose control among diabetes patients.~   "
92025|NCT02362594|"~     This study will assess whether post-resection adjuvant therapy with pembrolizumab improves~     recurrence-free survival (RFS) as compared to placebo for high-risk participants with~     melanoma (Stage IIIA [> 1 mm metastasis], IIIB and IIIC). The study will also assess whether~     pembrolizumab improves RFS versus placebo in the subgroup of participants with programmed~     cell death ligand 1 (PD-L1)-positive tumor expression. Participants will be stratified for~     stage of disease and region and then will be randomly assigned to receive either~     pembrolizumab or placebo.~      An interim analysis of efficacy is planned after approximately 330 RFS events have been~     reported and will be based on efficacy in the intention to treat population (primary efficacy~     population). If the superiority of pembrolizumab compared to placebo is confirmed, the final~     analysis will occur immediately after the interim analysis. The study will continue until 409~     RFS events have been reported if superiority is not confirmed.~   "
92026|NCT02362581|"~     Comparison of prophylaxis and on-demand treatment in children with moderate to severe~     hemophilia A.~      This study determines to compare the efficacy of prophylaxis and on-demand treatment in~     moderate to severe hemophilia A children in King Chulalongkorn Memorial Hospital, Bangkok,~     Thailand~   "
92027|NCT02362568|"~     The purpose of this study is to determine if cervical ultrasound exploration can predict~     difficult intubation better than main validated clinical criteria.~   "
93913|NCT02337881|"~     The aim of this study is to assess whether or not the emergency tocolytic effect of combined~     nifedipine and sildenafil citrate will have a superior effect over nifedipine alone in terms~     of inhibiting eminent preterm labor and improving perinatal outcomes.~   "
92028|NCT02362555|"~     Ossification of nuchal ligament often observed in patient with chronic neck pain, previous~     study showed ossification of nuchal ligament was associated with cervical spondylosis and~     radiculopathy. Patient with chronic neck pain was divided into two groups according to the~     presence of ossification of nuchal ligament on cervical radiographic images.~      This study is to evaluate and compare the neck function including range of motion, neck~     strength and pressure pain threshold, radiography characteristics and functional disability~     between two groups.~   "
92029|NCT02362542|"~     The purpose of this study is to investigate the effect of Transcranial Direct Current~     Stimulation (tDCS) on appetite control related brain regions.~   "
92030|NCT02362529|"~     The purpose of this study is to determine if translocator protein total distribution volume~     (TSPO VT) is elevated in major depressive disorder that is not responding to medication and~     if adding minocycline can affect TSPO VT. Many remain treatment resistant with common~     antidepressant treatments and the investigators think it may be due to poor targeting of~     brain pathologies.~   "
92031|NCT02362516|"~     To assess the exposure of BI 425809 in cerebrospinal fluid relative to plasma as well as~     safety and tolerability, and to evaluate the effect of different doses of BI 425809 on~     biomarkers levels in cerebrospinal fluid.~   "
92032|NCT02362503|"~     The purpose of this study is to determine whether the BMS Attachment Inhibitor (BMS-663068)~     is effective in the treatment of heavily treatment experienced HIV-1 patients with multi-drug~     resistance.~   "
92033|NCT02362490|"~     Antiviral therapy is the most important method to slow and stop the progress of the disease~     in patients with chronic hepatitis B (CHB). Nucleoside (acid) analogues (NA) can Effectively~     suppress HBV replication, but it should be continue used and relapse would happen in most~     patients after withdrawal of therapy. However, long-term use of NA could induce viral~     resistance mutation lead to loss of efficacy. Interferon treatment can enhance specific and~     non-specific immune function in chronic hepatitis B patients, make patients get immune~     control to HBV infection and obtain sustained response after treatment. Thus the CHB patients~     on the treatment of NA should be stop NA treatment after interferon treatment. In this study,~     the effects of interferon treatment in CHB patients who were on the NA treatment and obtained~     HBsAg level≤250 IU/ml.~   "
92034|NCT02362477|"~     The immediate objective of this project is to evaluate the clinical effectiveness of a~     telemental health modality (video-teleconferencing) for providing an evidence-based group~     intervention to female rural veterans, Reservists, National Guardsmen, and civilians~     suffering with PTSD. This study is an expansion, seeking to add a treatment arm of women, to~     an already CDMRP-funded study that completed in July 2014 treating male combat veterans with~     military-related PTSD. The long-term objective of this project is to disseminate an~     empirically sound TMH PTSD protocol for male and female veterans, Reserve and Guard that will~     extend the use of CPT to remote rural sites. It is hypothesized that using VTC, will be as~     effective as the in-person mode of service delivery for providing CPT.~   "
92035|NCT02362464|"~     Background:~      - Few studies or literature are available about the long-term safety of repeated peptide~     vaccinations in people over a period of time. Long-term vaccination may be needed to control~     tumors. Researchers gave a group of men a series of vaccine injections over 2 years. Now they~     want to give those same men the new version of the vaccine. They want to see if it produces~     different types of immune responses and also ensure that repeated vaccinations are safe.~      Objectives:~      - To find out the long-term safety of repeated TARP peptide vaccinations.~      Eligibility:~      - Men who took part in NCI protocol 09-C-0139.~      Design:~        -  Participants will be screened with blood tests, scans, physical exam, medical history,~          and an evaluation of how well they perform everyday activities.~        -  Participants will have apheresis. Blood will be removed with a needle from one arm. A~          machine will separate the white blood cells. The blood, minus the white cells, will be~          returned through a needle in the other arm.~        -  Participants will have 14 visits. At each visit, they will have a physical exam and~          blood tests. They will discuss any side effects.~        -  Participants will get vaccine injections at weeks 3, 6, 9, 12, 15, and 24. The vaccine~          will be made from the participants own cells.~        -  Participants will get a Vaccine Report Card to complete after receiving vaccine.~        -  The study lasts 96 weeks.~   "
92036|NCT02362451|"~     Background:~      - Men who continue to have an elevated or rising prostate specific antigen (PSA) level after~     their primary prostate cancer treatment are at increased risk for their cancer to progress.~     The time it takes to progress is highly variable. One way to predict this progression is~     based on the change in PSA levels over time. This is called the PSA doubling time (PSADT).~     Researchers want to test a vaccine on men with Stage D0 prostate cancer. Stage D0 means the~     PSA has become detectable again or has started to rise after primary treatment, but has not~     spread to other organs.~      Objectives:~      - To test a vaccine s effectiveness on the rate of PSA increase using PSADT and tumor growth~     rates.~      Eligibility:~      - Men with Stage D0 prostate cancer with a PSADT between 3 and 15 months.~      Design:~        -  Participants will be screened with blood tests, scans, physical exam, and medical~          history. Their prostate cancer will be confirmed.~        -  Participants will undergo apheresis. Blood will be removed with a needle from one arm. A~          machine will separate the white blood cells. The blood, minus the white cells, will be~          returned through a needle in the other arm.~        -  Participants will have 14 visits. At each visit, they will have a physical exam and~          blood tests. They will discuss any side effects.~        -  Participants will get injections of either the vaccine or placebo at weeks 3, 6, 9, 12,~          15, and 24. Both will be made from the participants own cells.~        -  Participants will be selected randomly to receive either active vaccine or placebo. For~          every two participants assigned to active vaccine, one participant will be assigned to~          placebo vaccine.~        -  Participants will get a Vaccine Report Card to to complete after receiving vaccine.~        -  The study lasts 96 weeks.~   "
92093|NCT02361710|"~     The aim of this study is determining the affects of serum vitamin D levels to implantation~     and clinical pregnancy rates in women undergoing elective vitrified/thawed embryo transfer.~     Two groups will be identified according to the serum vitamin D levels on eFET transfer day~     and later on implantation, clinical pregnancy and ongoing pregnancy rates will be compared~     between those groups~   "
93969|NCT02337153|"~     Codify the treatment of teeth by stiff Corticotomy technique. Evaluate the duration of~     treatment and tooth movement.~   "
92037|NCT02362438|"~     Background:~      - The Gigaxonin gene lets the body make a protein chemical called Gigaxonin. Nerves need~     Gigaxonin to work properly. Giant Axonal Neuropathy (GAN) causes a shortage of functional~     Gigaxonin. Nerves stop working normally in people with GAN. This causes problems with walking~     and sometimes with eating, breathing, and many other activities. GAN has no cure. Over time,~     GAN can shorten a person s life. Researchers want to see if a gene transfer treatment may~     help people with GAN.~      Objectives:~      - To see if a gene transfer is safe and shows potential to help people with GAN.~      Eligibility:~      - People age 5 and older with GAN.~      Design:~        -  For 2 months participants must live full-time within 100 miles of the NIH.~        -  Participants will be screened by phone and in person. They will take many tests. Some~          are listed below. Their medical records will be reviewed. Their caregivers may be~          contacted.~        -  Participants will have a total of about 30 visits, weekly, monthly, and then yearly over~          15 years. They will include many of the tests below.~        -  Physical and nervous system exams.~        -  Blood, urine, and stool samples.~        -  Nerve, lung, heart, and eye tests.~        -  Questionnaires.~        -  MRI scans, nerve biopsies, and spinal taps. Participants will be sedated for some tests.~        -  Speech, memory, muscle, and mobility tests.~        -  Skin biopsy (small sample removed).~        -  Participants will take many medicines. Some require intravenous lines.~        -  Participants will get the gene transfer through an injection by spinal tap into their~          cerebrospinal fluid, which flows around the brain and spinal cord. The genes are packed~          in a modified virus that carries the genes to cells in their body. Participants safety~          is not guaranteed.~   "
92038|NCT02362425|"~     Background:~      - Ryanodine receptor type 1-related myopathies (RYR1-RM) are the most common muscle diseases~     that people are born with in the U.S. They affect development, muscles, and walking.~     Researchers want to test a new drug to help people with these diseases.~      Objectives:~      - To see if the drug N-acetylcysteine decreases muscle damage in people with RYR1-RM. To see~     if it improves their exercise tolerance.~      Eligibility:~      - People age 7 and older with a confirmed genetic diagnosis of RYR1 or a clinical diagnosis~     of RYR1 and a family member with a confirmed genetic diagnosis.~      Design:~        -  Participants will be screened with a checklist of criteria. They will have a muscle~          biopsy. A needle will remove a tiny piece of muscle in the lower leg.~        -  Study visits will take several days.~        -  Visit 1:~        -  Medical history~        -  Physical exam~        -  Blood, urine, and saliva tests~        -  Questions about symptoms and quality of life~        -  Heart, lung, and walking tests~        -  Muscle Oxygenation Capacity Test. A blood pressure cuff around the thigh will be~          tightened for up to 10 minutes.~        -  Biodex testing, stretching the leg against resistance~        -  Muscle ultrasounds. A probe will be moved over the skin.~        -  Participants may be photographed or videotaped during procedures.~        -  They may have a muscle biopsy.~        -  Six months later, visit 2 will repeat visit 1. Participants will start taking the study~          drug dissolved in water or placebo three times a day for 6 months.~        -  Participants will stay at NIH for 2 days after starting the study drug.~        -  Participants will keep an online pill diary daily and be contacted by phone during the~          study.~        -  Six months after starting the study drug, study visit 3 will repeat some or all of visit~          1.~   "
92039|NCT02362412|"~     The purpose of this study was to evaluate the efficacy, safety, and pharmacokinetics of~     switching FK949E (sustained-release quetiapine) 50-mg and 150-mg tablets to the other tablet~     at the equivalent total daily dose in bipolar disorder patients with major depressive~     episodes.~   "
92040|NCT02362399|"~     To detect the effect of sildenafil citrate on Doppler parameters in fetuses suffering from~     growth restriction to support its use later as prolonged therapy in those pregnancies at~     higher risk for such complication.~   "
92041|NCT02362386|"~     The objective of the study is to assess the logistical and biological feasibility of~     preparing ADRCs from adipose tissue excised during standard-of-care burn wound excision using~     the Celution® System for autologous, same-day application to the burn wound.~   "
92042|NCT02362373|"~     The investigators will conduct a prospective, seven-month pilot study to explore~     pharmacokinetic (PK) and pharmacodynamic (PD) effects among women with epilepsy using the~     levonorgestrel intrauterine system (LNG IUS) for contraception. The investigators will enroll~     twenty women with well-controlled epilepsy maintained on stable anti-epileptic drugs (AED)~     therapy seeking the LNG IUS for contraception. The primary outcomes are AED levels and~     seizures before and after LNG IUS placement. Secondary outcomes include LNG levels, evidence~     of ovulation three weeks after insertion (serum progesterone >3ng/ml), bleeding and spotting,~     endometrial thickness, continuation, satisfaction and adverse events (removals, expulsions,~     side effects). The investigators will conduct a baseline month assessment, insertion visit,~     and follow-up visits at 21 days, three months and six months.~   "
92043|NCT02362360|"~     The purpose of this study is to investigate the influence of a new ostomy product on the~     peristomal fit for people with an ileo- or colostomy.~   "
92044|NCT02362347|"~     The purpose of this investigation is to determine the effect of a weighted compression vest~     in addition to usual medical care and exercise rehabilitation on cardiovascular,~     neurocognitive, balance and anxiety measures in individuals medically diagnosed with, and~     being treated for, a mild traumatic brain injury.~   "
92045|NCT02362334|"~     This study evaluates the various ocular parameters which are necessary for ocular biometry~     and the calculated IOL powers using both dual Schiempflug analyzer and optical low-coherence~     refelctometry.~   "
92046|NCT02362321|"~     Current opinion regarding the use of steroids in the treatment of chronic subdural hematomas~     are mostly based on observational studies. Here we present data from a prospective randomized~     pilot study of twenty chronic subdural hematoma (CSDH) patients treated with dexamethasone or~     placebo for 30 days.~      Twenty patients with computed tomography (CT)- or magnetic resonance imaging (MRI)-confirmed~     CSDH were recruited from a single center and randomized in order to receive dexamethasone or~     placebo as a conservative treatment. Patients affected to the treatment group received oral~     dexamethasone 12mg/day for three weeks followed by tapering. These patients were followed for~     6 months and the rate of success of conservative treatment versus placebo was measured.~     Parameters such as hematoma thickness and global impression of change were also compared~     before and after treatment with chi-square tests. Adverse events and complications were~     documented.~   "
92047|NCT02362308|"~     The investigators will test the hypothesis that endogenous aldosterone impairs insulin~     secretion and insulin sensitivity in subjects with primary aldosteronism.~   "
92048|NCT02362295|"~     PARME study had 3 objectives:~        -  To identify the specific number of incarcerated individuals with terminal illness in~          need of palliative care.~        -  To describe the health and penal situation of these prisoners.~        -  To analyse the situation of these ill prisoners especially in the context of suspended~          sentence for medical ground~      In order to answer these questions, the investigators used a mixed method research.~   "
92049|NCT02362282|"~     Recent research in gait training for stroke survivors showed that coordinated gait components~     can be best restored using the following interventions together: coordination exercises, over~     ground gait training, and body weight supported treadmill training (BWSTT). These results are~     important because, to the investigators' knowledge, there have been no other reports of the~     restoration of coordinated gait components for those with persistent gait deficits (> 6~     months after stroke). However, a remaining problem was that the restored coordinated gait~     movements measured in the laboratory did not generalize for many subjects to the everyday~     environment. The confluence of several factors can cause lack of generalization. First, dual~     task performance (gait and cognitive attention task) can degrade both gait and attention~     ability, even in healthy adults. Second, stroke can impair attention. Third, during walking~     in the everyday environment, attention is required in order to safely process normally~     occurring stimuli. Therefore, given the success of the new gait training protocol in the lab~     setting, it is important to address the problems remaining for generalization of the~     recovered coordinated gait pattern to the everyday environment. The primary hypothesis of~     this study is that greater gains in gait speed will be produced by combined motor and~     cognitive training versus motor training alone.~   "
92050|NCT02362269|"~     The proposed study is a randomized, double-blind, controlled, multi-center clinical trial of~     six months of daily oral vitamin D3 (cholecalciferol). This study will randomize 334~     community-dwelling post-menopausal women of European and African descent (~167 from each~     ancestry) in a 1:1 ratio between the control arm and the dosing algorithm arm using~     stratified block randomization with a block size of six and stratification by site~     (ancestry). The sample size of 334 includes 10% over-recruitment to allow for loss to~     follow-up. The European ancestry women will be seen in the Madison clinic and the African~     ancestry women will be seen in the Milwaukee clinic. The proposed study will focus on~     post-menopausal women because this is the subset of the population that both Dr. Engelman's~     and Dr. Binkley's preliminary data are drawn from. Moreover, 25(OH)D concentrations are~     typically lower in women and in older individuals, since production of vitamin D in the skin~     following sun exposure decreases with age. Therefore, this group of individuals is likely to~     benefit the most from vitamin D supplementation, especially when personalized based on~     biology using the proposed dosing algorithm.~   "
92051|NCT02362256|"~     The aim of this study is to investigate which method of naltrexone induction during rapid~     opioid detoxification causes stronger stress response and has a higher influence on opioid~     abstinence caused by opioid induction.~   "
92052|NCT02362243|"~     Purpose and Aims: The purpose of this study is to assess the clinical effectiveness of back~     and core exercise interventions for low back injury prevention in firefighters. Aim 1.~     Compare the effectiveness of 2 worksite exercise interventions (supervised, web-based)~     relative to control to reduce lost work days related to low back injury and illness in~     firefighters.~      Relevance: Low back injury is one of the most common and disabling disorders in firefighters.~     Thus, novel interventions are needed to counteract the adverse consequences of this disorder~     and its impact on firefighter safety.~      Methods: A cluster randomized controlled trial will be conducted in career, full active duty~     firefighters (n = 345) who will be randomly assigned (by fire station) to 1 of 3 intervention~     groups - 1) supervised exercise (n = 115), 2) web-based exercise (n = 115), or 3) control (n~     = 115). Participants in the supervised and web-based exercise groups will perform back and~     core exercises previously tested in our recent FEMA-funded grant (EMW-2009-FP-00418), twice~     per week for 12 months while on duty, in addition to their usual physical fitness routine -~     The supervised group will perform exercise under direct supervision of certified exercise~     specialists, and the web-based group will utilize a web-based exercise system. The control~     group will not perform back and core exercises, but will continue their usual physical~     fitness routine and receive brief education on general exercise and physical activity~     principles. Outcome measures include low back injury and illness data obtained and~     cross-checked from various sources, other standard clinical outcome measures for low back~     pain and disability, and validated physical fitness tests.~      Anticipated Outcomes: We hypothesize that the supervised and web-based interventions will~     reduce lost work days related to low back injury and illness by 40% compared with control.~     Assuming positive results, this study will deliver an evidence-based exercise intervention~     for low back injury prevention specifically designed for firefighters and assessed in a~     full-scale randomized controlled trial.~   "
92053|NCT02362230|"~     Evaluating the safety and efficacy of Icotinib administered in 2-month treatments, in~     patients with metastatic triple-negative breast cancer that have received at least two prior~     treatments.~   "
92054|NCT02362217|"~     This study is aimed at assessing the safety of candidate Hepatitis C vaccines~     AdCh3NSmut/MVA-NSmut and HIV vaccines ChAdV63.HIVconsv/MVA.HIVconsv when administered~     separately or in combination to healthy volunteers. The study also aims to assess the~     cellular immune response generated by these vaccines when administered as mentioned above.~   "
92055|NCT02362204|"~     Lung cancer patients experience significant physical symptoms, psychological distress and~     have many supportive care needs that impact on quality of life. Implementing the role of a~     Lung Cancer Nurse (LCN) is a response to meet the needs of patients and caregivers.~      Primary aim is to assess the feasibility of a LCN intervention and feasibility to collect~     longitudinal patient self-assessment questionnaires at the Thoracic Cancer Centre of the~     University Hospital of Lausanne.~      Secondary aims are: i) to describe self-reported changes in self-efficacy, symptoms and unmet~     supportive care needs across three time points during the first line therapy and ii) to~     explore professional acceptability of the new LCN model evaluating the perceptions of~     barriers and facilitators of the model by the LCN and the other multidisciplinary members of~     the comprehensive lung cancer care team.~      An exact single-stage (no interim analysis) design will be applied to determine feasibility~     for further studies to be undertaken. Secondary outcomes will be analyzed descriptively at~     each data collection (Baseline, Time1, Time2) time point and professional acceptability will~     be explored by focus groups with selected members of the interdisciplinary team.~   "
92056|NCT02362191|"~     Purpose: Using transcranial alternating current stimulation (tACS), the investigators will~     study and attempt to treat mood dysregulation in women with premenstrual dysphoric disorder~     (PMDD).~      Participants: Women between ages 18-45 with a diagnosis of PMDD confirmed by participation in~     a PMDD diagnostic study (IRB# 05-3000).~      Procedures (methods): After a re-screening and consent appointment, eligible participants~     will begin daily ratings and have baseline EEG performed during the follicular and luteal~     phases. Following the luteal phase EEG, the patient will receive, in a double blind~     cross-over fashion, 5 days of tACS, 40 minutes/session, performed in two successive months.~     On the first and fifth days of each treatment, EEG will be performed. Patients' symptoms will~     be assessed at the end of each session and with the daily mood ratings.~   "
92094|NCT02361697|"~     This is a prospective, non-randomised, non-blinded, single center study of children and~     adolescents with multiple sclerosis and clinically isolated syndrome to detect differences or~     early changes in diffusion-weighted imaging (DTI) by magnetic resonance imaging (MRI).~   "
92057|NCT02362178|"~     Blood products are commonly used before invasive procedures in patients with end-stage liver~     diseases despite cirrhosis being a thrombophylic state. Traditional coagulation tests (namely~     INR and PLTs count) are known to be unreliable in predicting bleeding risk before invasive~     procedures and in representing the real coagulation status of cirrhotic patients.~     Notwithstanding they are still used to guide blood products administration before invasive~     procedures. Thromboelastography (TEG) has been shown to be effective in detecting signs of~     hypo-hypercoagulability possibly being an alternative method to guide blood products~     transfusion. The aim of this randomized controlled study was to evaluate the efficacy of TEG~     as a guide for blood products transfusion in cirrhotic patients undergoing invasive~     procedures.~   "
92058|NCT02362165|"~     Bortezomib-based triple-drug combination has greatly improved the response rate of multiple~     myeloma patients. Bortezomib,doxorubicin,and dexamethasone (PAD) is commonly used in clinical~     practice.Recent studies have found that cyclophosphamide, bortezomib,and dexamethasone~     (CyBorD)seems better than PAD in efficacy. However, there is no randomized phase 3 trial~     comparing these two regimens in the treatment of newly diagnosed multiple myeloma patients.In~     this study, the investigators will compare the efficacy and safety of these two regimens~     using once-weekly subcutaneous injection of bortezomib.~   "
92059|NCT02362152|"~     This non-interventional, multinational study of topical field treatment of actinic keratosis~     (AK) aims to collect real-life experience with ingenol mebutate as well as one or two other~     topical field therapies commonly used in the individual country. Physicians will report~     baseline characteristics, while the main study focus will be on patient reported outcomes 3-4~     weeks after treatment completion (treatment satisfaction, adherence, resource utilization and~     Health Related Quality of Life.~      Dermatology centres in Denmark, Norway, Sweden, the Netherlands, the United Kingdom and~     Canada will participate.~   "
92060|NCT02362139|"~     In the investigators institution, there is a wide use of Papaverine in delivery room, but~     this use is optional, and is left to the discretion of the physician.~      The aim of the investigators study is to prospectively evaluate the influence of Papaverine~     administration in the latent phase of labor, on the duration of labor.~   "
92061|NCT02362126|"~     Observational prospective multicenter study to investigate efficacy and safety of endoscopic~     full thickness resection in the lower GI tract using a novel over-the-scope full thickness~     resection device.~   "
92062|NCT02362113|"~     A total of 300 adults would be included in the present cross-sectional study. glycemic index~     (GI) and glycemic load (GL) would be assessed by using a validated self-administered~     dish-based semi-quantitative food frequency questionnaire. Validated Iranian versions of~     Hospital Anxiety and Depression Scale and General Health Questionnaire-12 would be used to~     assess anxiety, depression and psychological distress.~   "
92063|NCT02362100|"~     The primary objective is to determine if a difference exists in functional outcomes, as~     measured by the Constant score, when comparing nonoperative management and locking plate~     surgical fixation of low-energy displaced proximal humerus fractures in the elderly~     population over a 2-year follow-up period. Secondary outcomes will include an assessment of~     the ASES score, the SF-36 quality of life score, complication rates, re-operation rates,~     radiographic time to union, radiographic malunion, hardware position and evidence of~     avascular necrosis or posttraumatic osteoarthritis .~   "
92064|NCT02362087|"~     The purpose of this study is to document what course of action physicians choose for their~     patients when they develop taxane acute pain syndrome (TAPS) and to identify patients at the~     greatest risk of TAPS by examining specific human genome markers such as single nucleotide~     polymorphisms (SNPs) and Copy Number Variations (CNVs) that may explain the genetic~     (hereditary) component.~   "
92065|NCT02362074|"~     The purpose of this study is to describe the impact of treatment with adalimumab on work~     related productivity and economic burden in patients with Rheumatoid Arthritis (RA) treated~     in Canada.~   "
92066|NCT02362061|"~     100 patients aged 21-40 years old, diagnosed as primary or secondary infertility . These~     patients are then assigned to receive fertility treatment (ovulation induction, ICSI,~     intrauterine insemination and IVF). They undergo a 3D vaginal ultrasound before treatment to~     measure the junctional zone thickness and followed up after treatment to determine the rate~     of implantation.~   "
92067|NCT02362048|"~     ACP-196 Alone and in Combination with Pembrolizumab in Subjects with Advanced or Metastatic~     Pancreatic Cancer~   "
92068|NCT02362035|"~     This study is evaluating the safety, pharmacodynamics (PD), and efficacy of acalabrutinib and~     pembrolizumab in hematologic malignancies.~   "
92069|NCT02362022|"~     Combination of volatile and opioid agents are used to achieve unconsciousness, haemodynamic~     stability and analgesia for surgical prosedures. This prospective, randomized, double-blind,~     controlled study evaluates the effects of two different doses of morphine sulphate (0.1 mg/kg~     and 0.2 mg/kg), on desflurane consumption, recovery characteristics, postoperative analgesic~     requirements and side effects during total abdominal hysterectomy.~   "
92070|NCT02362009|"~     The purpose of the Fibroid Registry is to provide a comprehensive database that captures~     patient characteristics, clinical outcomes and pot-treatment quality of life measures for~     patients treated for uterine fibroids. This database will serve as a platform for future~     comparative effectiveness and other health services research studies.~   "
92095|NCT02361684|"~     To compare the clinical and cost-effectiveness of blended Cognitive Behavioural Therapy (CBT)~     for adults with major depressive disorder (MDD) with treatment as usual (TAU) in Spanish~     population.~   "
92096|NCT02361671|"~     Elevated intracranial pressure (ICP) is a common and potentially life threatening condition~     arising from a variety of pathological conditions. The ability to monitor ICP is a crucial~     aspect in the management of these patients. Currently, the diagnosis of whether ICP is~     elevated or not is determined either with clinical signs (headache, nausea and vomiting or~     visual disturbances) or from the changes in the preoperative neuroimaging modalities such as~     computerized tomography (CT scan) and/or magnetic resonance imaging (MRI).~      Recently, transorbital ultrasonography has gained popularity as a noninvasive bedside exam~     that has been shown to be useful in the diagnosis of raised ICP by evaluating the change in~     the optic nerve sheath diameter (ONSD).~      The aim of our study is to use transorbital ultrasound to evaluate ONSD changes in patients~     with intracranial pathology and to compare the changes in the ONSD before and after surgical~     intervention as well as between patients with and without clinical or radiological signs of~     increased ICP.~   "
92071|NCT02361996|"~     It is a common understanding that patients with coronary heart disease are suffering, among~     others, from reduced myocardial perfusion. In order to increase (normalize) the reduced~     perfusion, when conventional approach failed, coronary bypass surgery, coronary vessel~     dilatation/stenting are performed. The similar situation with reduced myocardial perfusion~     may be found in patients with stenosis of the aortic valve, where aortic valve replacement~     may increase myocardial perfusion by left-ventricular remodelling. However, there is~     presently no method established to measure myocardial perfusion quantitatively and~     noninvasively before and after a therapeutic intervention.~      Data of pre- and post-therapeutic myocardial perfusion, quantitatively measured in~     ml/100g/min would strengthen the indication for specific therapeutic approach and enable an~     objective control of effectiveness of the applied therapy.~      Hypothesis:~      There is a measureable difference in quantitative myocardial perfusion values before (lower)~     and after (higher) interventional or surgical procedure.~      The goal of the study is to measure myocardial perfusion by advanced CT technology (e.g. iCT~     256 Brilliance ) quantitatively in ml/100g/min in three groups of patients:~        1. Before and after coronary bypass surgery~        2. Before and after coronary vessel dilatation/stenting~        3. Before and after aortic valve replacement.~      The investigators will not assign specific interventions to the subjects of these three~     groups. Therefore, the research is strictly observational.~      Design:~      Prospective study to measure quantitatively myocardial perfusion in the above mentioned three~     groups of patients with simultaneous control and registration of all essential, physiological~     determinants of myocardial perfusion immediately prior to each CT study. The CT myocardial~     perfusion measurements will be performed directly after the indication for intervention or~     surgery and on the last day before discharge from hospital.~      All the collected data (determinants) inclusively the CT-studies will be anonymised and~     archived on a local server. The investigators of the University of Medical Computed Sciences~     and Technology, Innsbruck / Austria will perform the evaluation of the myocardial perfusion~     measurements and all statistical analysis independently of the CT-studies performing~     physicians.~   "
92072|NCT02361983|"~     The aim of this study is to compare the success rate of lung isolation and time to accomplish~     a correct placement of the device between anesthetists with experience in thoracic anesthesia~     (defined as at least 4 years clinical practice experience as attending anesthetists in~     thoracic) and residents in training in thoracic anesthesia.~   "
92073|NCT02361970|"~     The purpose of the study is to evaluate the status and function of gamma delta T cells in~     peripheral blood of sepsis patients.~   "
92074|NCT02361957|"~     RATIONALE: The underlying etiology in inflammatory bowel diseases such as Ulcerative Colitis~     is not yet fully understood. Studies suggest a relation between higher intestinal~     permeability and aberrant changes of the epithelium. Dysbiosis of the intestinal microbiota~     might be the cause. Probiotics may restore the balance of the intestinal microbiota. In~     theory this could improve intestinal permeability and therefore reduce disease activity and~     maintain remission in patients with Ulcerative Colitis.~      OBJECTIVE: To investigate whether a specifically designed multispecies probiotic mixture~     (ecologic 825®), as adjuvant therapy, can contribute to an improvement of intestinal~     permeability, microbiota composition, disease activity and inflammatory markers in ulcerative~     colitis.~      STUDY DESIGN: 12-wk placebo-controlled randomized double-blind intervention with 2 parallel~     arms.~      STUDY POPULATION: Adults diagnosed with left sided Ulcerative Colitis or Pancolitis in~     remission or mild stage of the disease. For inclusion of the patients the Patient Simple~     Clinical Colitis Activity Index (P-SCCAI) will be used.~      INTERVENTION: Patients will receive either two daily dosages of 3 g of Ecologic® 825 or two~     daily doses of 3 g of the placebo, containing only the carrier material (both produced by~     Winclove Probiotics).~      MAIN STUDY PARAMETERS/ENDPOINTS: Main study parameter is intestinal permeability measured by~     several techniques: the lactulose/mannitol absorption test (L/M test), LPS levels in blood~     serum and faecal zonulin. Secondary, inflammation will be measured from faecal calprotectin~     and blood c-reactive protein (CRP) levels. Furthermore samples will be stored to measure~     cytokine concentrations in serum and to analyse the microbial composition of the faecal~     samples using the HITchip. For the disease related quality of life the irritable bowel~     disease questionnaire (IBD-Q) and SF-36 will be used. All parameters will be measured at~     three time points; t=0, t=6 and t=12 weeks.~   "
92075|NCT02361944|"~     The investigators will recruit and randomize 200 elective cardiac surgery patients to receive~     physiologic oxygenation (normoxia) or hyper-oxygenation (hyperoxia) during surgery to test~     the hypothesis that intraoperative physiologic oxygenation decreases the generation of~     reactive oxygen species, oxidative damage, and postoperative organ injury compared to~     hyper-oxygenation.~   "
92076|NCT02361931|"~     The investigative product, developed by Remedor, is a unique gel formulation that optimizes~     the administration of EPO to the wound bed. This novel formulation has been shown to~     stabilize EPO in the gel and to maintain its activity over long periods.~   "
92077|NCT02361918|"~     Evaluating predictive value of serum procalcitonin, C-Reactive Protein, drain IL-6 and~     TNF-alpha for anastomotic leakage in post-operative period.~   "
92078|NCT02361905|"~     Cellular leiomyomas (CLs) are described as leiomyomas that are significantly more cellular~     than the surrounding myometrium, often with crowding and overlapping of nuclei. they often~     are soft and appear more tan or yellow and less circumscribed than the usual leiomyomas.~     Pre-operatively CLs can be recognized at ultrasound evaluation because they appear as~     hypoechoic uterine lesions. patients with hypoechoic myoma have a significantly longer~     surgery time after treatment with a gonadotropin-releasing hormone (GnRH) analog probably~     related to degenerative changes induced by this treatment. Hypoechoic CLs should be more~     responsive to ulipristal acetate treatment than common leiomyomas. The antiproliferative~     ulipristal effect, moreover, induces a condition of apoptotic necrosis that, compared to~     GnRH-a myxoid necrosis, probably allows an easier surgical enucleation of the tumor.~   "
92079|NCT02361892|"~     The uterine leiomyoma is the most common female benign disease.UPA seems to be most effective~     for the medical management of fibroids and could be place as preoperative adjunct to surgery~     but also as medical therapy to avoid surgery. No data have been published about the effect of~     UPA on FSH (Follicle stimulating hormone) or AMH levels nor on ovarian antral follicle count~     (AFC) or vascularization indexes during and after treatment. Considering that in young women~     of reproductive age (under 40 years old), desiring pregnancy, UPA has been proposed to avoid~     or postpone surgery, also in a long-term administration program, data about its effect on~     women ovarian reserve are urgently needed.~      For these reasons, data on biochemical (AMH, FSH and E2) and 3D ultrasonographic (VI, Flow~     index, AFC) parameters of women treated by UP are needed to assess the effect of the drug in~     terms of ovarian reserve modification.~   "
92080|NCT02361879|"~     The uterine leiomyoma is the most common female benign disease. Submucosal fibroid are about~     10%, they distort the endometrial cavity causing heavy and/or irregular bleeding (AUB) and~     infertility. Hysteroscopic removal of submucosal myomas improves this conditions. GnRH~     analogues are commonly used before hysteroscopic myomectomy to make surgery easier and safer,~     but they are expensive, have potential side effects and lack a robust evidence base to~     support this practice. Ulipristal acetate treatment was able and faster to control in 90% of~     cases uterine bleeding associated with fibroids than GnRH agonists. UPA significantly~     improved quality of life and pain reduction.~   "
92081|NCT02361866|"~     The purpose of this study is to evaluate the effectiveness(immunogeneicity) and safety of~     'GC1107' administered intramuscularly in healthy Adults.~   "
92082|NCT02361853|"~     Accumulating evidence suggest that the proliferative, invasive, and immune tolerance~     mechanisms that malignant tumors use to establish a nutrient supply and evade or edit the~     host immune response are similar to those used by the developing placenta during normal~     pregnancy. In addition to the shared capacity for invading through normal tissues, both~     cancer cells and cells of the developing placenta create a microenvironment supportive of~     both immunologic privilege and angiogenesis.~      CD11b+Gr1+ cells are a heterogeneous population of bone marrow-derived cells (BMDC) that~     consist of immature myeloid cells (IMCs), and were first described as myeloid-derived~     suppressor cells. In healthy individuals, IMCs that are generated in the bone marrow~     differentiate into mature granulocytes, macrophages, or dendritic cells (DCs). These cells~     have been shown to play an essential role in mediating immune suppression in animal models of~     human tumors. As a result of tumor-induced alterations in myelopoiesis, IMCs have been found~     in peripheral blood, lymphoid organs and the tumor tissue itself. An increased population of~     IMCs was identified in patients with several tumor types. Accordingly, IMCs detected in the~     peripheral blood of such patients bearing express the common myeloid marker CD33 but lack~     markers of mature myeloid cells such as the MHC class II molecule HLADR.~      IMCs have been shown to actively promote tumor growth and metastasis by modulating the~     cytokine environment, and through vascular remodeling by promoting angiogenesis.~      It has been demonstrated in our laboratory that IMCs infiltrate placentas of pregnant mice~     and actively promote angiogenesis. These cells show striking similarity to IMCs that populate~     malignant tumors. Accordingly, human placentas are also infiltrated by a significant~     population of IMCs. Immunostaining of human placentas showed that IMCs comprise around 25% (~     range 10-40%) of total placental CD45+ bone marrow-derived hematopoietic cells and that this~     population is located close to blood capillaries. The investigators also demonstrated that~     immature DCs, cells originally described to regulate the adaptive immune response, also~     promote angiogenesis in models of choroidal neovascularization, endometriosis and tumors.~      Tho objective in this proposed study is to compare the abundance of IMC, DC, monocytes and~     neutrophils counts in blood samples of normal pregnancies: 1. in women in term active labor.~     2. In women not in labor. 3. In pre term labor.~      According to our previous findings, the investigators hypothesize that IMC's, monocytes and~     in active delivery (both term and pre term) will be lower than women without signs for labor.~     The investigators also hypothesize that DC's and neutrophils will be more abundant in active~     delivery (in term and pre term) than women without signs for labor.~      Experimental plan:~      Blood count will be collected from pregnant women who agree to participate in the research:~      The samples will be sent for the routine complete blood count in Hillel Yaffe hematologic lab~     and also will be analyzed for IMC's and DC's population in our lab using fluorescent~     immunostaining with specific monoclonal antibodies and flow cytometry.~      IMC's per total CD45 positive hematopoietic cells from the placental tissue will be analyzed~     using fluorescent immunostaining with specific monoclonal antibodies and flow cytometry . The~     specific location of these cells in the placenta will be identified within the placental~     tissue using Immunohistochemistry (IHC). The expression of pro angiogenic genes will be~     analyzed by RT PCR and Western blotting.~   "
92132|NCT02361203|"~     The purpose of this study is to determine whether aerobic exercise can enhance the effects of~     exposure therapy treatment for fear of heights.~   "
92083|NCT02361840|"~     Shock is one of the five leading causes of income and mortality in emergencies. It generates~     a decrease in the availability of oxygen to the tissues, resulting in ischemia, pulmonary~     involvement and tissue reperfusion syndrome. This pathologies can trigger Syndrome of Acute~     Respiratory Distress (ARDS) and death.~      Troponin I (TI) has been reported as early marker for ischemia and mortality other than~     coronary syndromes in critical patients.~      Objective. Set the increase of TI as a predictor of ARDS in children with shock.~      Null hypothesis. Increase serum in children with shock predicts the onset of ARDS.~      Methodology. Prospective cohort type test diagnostic. Displays institutional. Sampling~     non-probability, consecutive inclusion. Calculation of the sample size: interval of~     confidence (IC) 95%, power - 80%; ratio non-exposed: exposed 2:1; n = 62.~      Inclusion criteria: informed consent signed by the parent; children admitted to pediatric~     emergency (PEU) 1 month to 14 years with shock requiring mechanical ventilation.~      Exclusion criteria: intake of toxic (TI value increment per will), ≥3 concentrated~     erythrocyte transfusion or plasma prior to entering PEU.~      The investigators call exposure to the increase of TI≥0 05ng/ml and event to the development~     of ARDS. Determine TI value in plasma serum in the first 24 h, through Enzyme Immunoassay for~     the Quantitative Determination of Cardiac-Specific Troponin-I in Human Serum (cTnI ELISA),~     (reported as cardiac triage). Monitoring for 7 days.~      Study was approved by Hospital Ethics Committee (Research record 003/12)~   "
92084|NCT02361827|"~     To date, several studies have been done to explore the relationship between Vitamin D level~     and IVF outcome; however, the results are controversial. Sample sizes in these studies~     mentioned above were relatively small. In addition, there are no prospective cohort studies~     in this field. Thus, here the investigators carry this prospective observational cohort study~     to demonstrate the relationship between vitamin D level and IVF outcome.~   "
92085|NCT02361814|"~     The objective of this pilot study is to gain observational insight into potential preventive~     features of amniotic membrane transplantation in the adhesion formation after flexor tendon~     repair.~   "
92086|NCT02361801|"~     Inotropic agents are usually administered in the postoperative period after cardiac surgery.~     In most cases, dobutamine is administered routinely, for the probable occurrence of~     myocardial dysfunction after cardiopulmonary bypass or a low cardiac output with minimal~     evidence of altered tissue perfusion.~      Recent data show that inotropic agents are used in 35-52% of cardiac surgeries in the~     perioperative period. However, the use of inotropic agents may be associated with adverse~     events, including myocardial ischemia, by elevation in myocardial oxygen consumption and the~     imbalance between supply and consumption, and tachyarrhythmias (atrial fibrillation, sinus~     tachycardia, ventricular tachyarrhythmias), primarily due to the β1-adrenergic effect.~      This study is a non-inferiority clinical randomized study aiming to compare the use of~     dobutamine in a liberal strategy (in all patients at the time of withdrawal of CPB) with a~     restrictive strategy (based on clinical and hemodynamic evidence of low cardiac output~     syndrome associated with altered tissue perfusion). Our primary hypothesis is that the~     restrictive use of dobutamine is as safe and effective as the liberal one.~   "
92087|NCT02361788|"~     Background:~      Neonatal hyperbilirubinemia is the most common reason for admission in the neonatal period~     (first month of life) worldwide and at SMRU. The skin of the newborn baby becomes jaundiced,~     which is caused by a high level of bilirubin in the blood. In some neonates the level of~     bilirubin increases to a level that can cause braindamage or even death. There are different~     causes known that can lead to higher levels of bilirubin, for example G6PD deficiency and~     prematurity. In case of neonatal hyperbilirubinemia the neonate needs to be treated with~     phototherapy (blue light therapy). If there is prolonged jaundice (≥ 21 days), further~     investigations needs to be done.~      Objectives:~      Primary objective:~      To determine the etiology of neonatal hyperbilirubinemia in neonates with a gestational age~     of ≥ 28 weeks from the refugee and migrant population, on the Thai-Myanmar border.~      Secondary objective:~        -  Establishing the incidence of neonatal hyperbilirubinemia~        -  Determine the risk factors for the development of neonatal hyperbilirubinemia~        -  Determine the incidence of prolonged neonatal jaundice~        -  Determine the neurodevelopmental outcome, at the age of 6 and 12 months~        -  Determine the body composition, using air-displacement plethysmography, at birth, 1, 2~          and 3 months of age~        -  Determine the incidence of anaemia and illness episodes during the first year of life~        -  Determine the incidence of helminthic infection at the age of one year~        -  Assess the knowledge level and misbeliefs on neonatal hyperbilirubinemia among the~          mothers and SMRU health care staff~      Research design:~      The study will conduct an exhaustive prospective descriptive study, all eligible newborns~     will be enrolled after obtaining the informed consent from their mothers. During pregnancy~     and delivery we will collect clinical data about the mother. At birth we will take umbilical~     cord blood (9 ml) to test for different causes of neonatal hyperbilirubinemia. In the first~     week of life we plan 4 moments to measure the bilirubin and hematocrit level (0.05 ml),~     weight and ask questions about feeding and other practices. Based on the bilirubin results we~     will determine whether the neonate needs phototherapy. After the first week we weekly~     follow-up will be conducted and in case of visible jaundice we will measure the bilirubin~     level. If the neonate is still jaundiced after the age of 21 days we will further investigate~     the cause. In the infant period, until the age of one year, we plan to have monthly follow-up~     to assess the health and growth of the child and at the age of 3, 6 and 12 months we will do~     a neurodevelopmental test.~      An improved understanding of the pathological processes contributing to the development of~     neonatal hyperbilirubinemia is needed in order to to identify neonates at risk and develop~     improved management.~   "
92088|NCT02361775|"~     Level I randomized prospective outcomes study comparing two groups of patients. One group~     will receive Dilaudid patient controlled analgesia (PCA) post-operatively. The other will~     receive an ultrasound guided paravertebral block with indwelling paravertebral catheter with~     an infusion of 0.2% Ropivicaine post-operatively and a PCA.~   "
92089|NCT02361762|"~     The goal of the project is to better understand executive control—how children manage complex~     or conflicting information in the service of a goal. This skill has been linked to social and~     academic functioning in typically developing children. Executive control is often reduced in~     children with autism spectrum disorders, but it has not been a focus of treatment. This~     project will have the goal of determining whether computer-training tasks developed to~     enhance the executive control skills of preschoolers and school-aged children without autism~     are appropriate for children with ASD. The investigators do not yet know if this training is~     beneficial for children with ASD. In addition, because executive control has been found to~     relate to social knowledge and problem solving, the investigators will collect information~     with this type of task to measure possible effects of training.~   "
92090|NCT02361749|"~     Chronic idiopathic constipation is most common cause of Constipation in childhood with~     numerous cases in Egypt. Numerous conservative measures were tried but many fail. Surgical~     options include Longitudinal Myectomy of the muscle or injection of Botulinum toxin.~     Objectives: Comparative study between Botulinum toxin injection and Myectomy in treatment of~     Idiopathic Constipation~   "
92091|NCT02361736|"~     Hydroxyethyl starch (HES) is commonly used as plasma expander during surgery but may be~     nephrotoxic as seen in studies in patients with sepsis. The investigators hypothesized that~     the possible nephrotoxicity of 6% HES 130/0.4 could be revealed by measurements of urinary~     and plasma neutrophil gelatinase-associated lipocalin and interleukin-18 (IL-18) in old~     patients with normal renal function during orthopaedic surgery.~   "
92097|NCT02361658|"~     Elevated intracranial pressure (ICP) is a common and potentially life threatening condition~     arising from a variety of pathological conditions including traumatic brain injury (TBI),~     intracranial hemorrhage, subarachnoid hemorrhage and brain tumors. Monitoring the ICP is the~     most important aspect of the management of these patients. Recently, transorbital~     ultrasonography has gained popularity as a noninvasive bedside exam that has been shown to be~     useful in the diagnosis of raised ICP by evaluating the change in the optic nerve sheath~     diameter (ONSD). Transorbital ultrasonographic measurement of ONSD appears to be a~     noninvasive, relatively inexpensive bedside examination for the diagnosis of raised ICP. The~     investigators aimed to determine the changes in ONSD with acute controlled changes in ICP in~     healthy volunteers. The controlled changes in ICP will be produced by manipulating the PCO2~     with the use of Respiract and jugular venous compression with the use of custom made neck~     collar.~   "
92098|NCT02361645|"~     The purpose of this study is to assess vitreous concentrations of nonsteroidal~     antiinflammatory drugs (NSAIDs) and prostaglandin E2 in patients treated with NSAIDs before~     vitrectomy.~      A total of 0.5 to 1 mL undiluted vitreous was removed from the midvitreous cavity at the~     beginning of the surgery before infusion with balanced salt solution. Samples were~     immediately frozen and stored at -40°C until analysis. Samples were evaluated in a masked~     fashion. Vitreous concentrations of the study drugs were quantified using a reverse-phase~     liquid chromatography mass spectroscopy system. The minimum quantification limit for~     ketorolac, bromfenac, nepafenac, and amfenac was 0.8 ng/mL. Prostaglandin E2 concentrations~     were determined using a commercially available competitive enzyme immunoassay kit (R & D~     Systems, Minneapolis, MN).~   "
92099|NCT02361632|"~     The intention of this study is to determine wether coffee added milk change gastric volume in~     comparison with gastric volume after drinking black coffee~   "
92100|NCT02361619|"~     Four periods of oral dosing following overnight fasting (1. known metabolic probe drug~     cocktail consisting of caffeine, diclofenac, esomeprazole, metoprolol, midazolam; 2.~     dabigatran + cocktail; 3. dabigatran alone; 4. clarithromycin 3 days + cocktail +~     dabigatran). Blood samples collected for pharmacokinetics over 24 h. Washout between periods.~     Adverse events, haematology and clinical chemistry recorded.~   "
92101|NCT02361606|"~     Adolescents are often reluctant to receive psychological help. The investigators developed a~     web-based cognitive behavioral self-help intervention for adolescents with type 1 diabetes.~     The investigators aimed to examine the participation rate and outcomes on glycemic control~     and quality of life.~   "
92102|NCT02361593|"~     The aim of this study is to evaluate efficacy and safety of transparent cap-assisted~     endoscopic sclerotherapyI(lauromacrogol injection) in management of esophageal varices.~   "
92103|NCT02361580|"~     Primary null hypothesis:~      • Keeping a personal diary has no effect on upper-extremity disability (assessed w/ PROMIS~     [Patient Reported Outcome Measurement Information System] upper extremity) 8 weeks after~     injury.~      Secondary null hypotheses:~        -  Keeping a personal diary has no effect on avoidance of painful activities (assessed w/~          PROMIS pain interference) 8 weeks after injury.~        -  Keeping a personal diary has no effect on symptoms of depression (assessed w/ PROMIS~          depression) 8 weeks after injury.~        -  There are no factors associated with upper-extremity disability 8 weeks after injury.~   "
92104|NCT02361567|"~     Opioid naive patients are randomized to receive either TRAMACET or PERCOCET at the time of~     discharge following mild to moderate pain risk surgery. The following will be assessed: 1)~     Brief pain inventory (BPI) for the month. 2) Post operative pain management satisfaction. 3)~     Whether they sought any repeat opioid prescription. 4) Whether they intend to seek repeat~     opioid prescription. It is expected that both groups will have similar pain outcomes but~     those patients in the Percocet group will be more likely to seek a second prescription.~   "
92105|NCT02361554|"~     The purpose of this pilot study is to investigate the use of deep brain stimulation (DBS) of~     the substantia nigra pars reticulata (SNr) in subjects with treatment-resistant~     schizophrenia. There is a subset of patients with schizophrenia who continue to have~     persistent psychotic symptoms (auditory hallucinations and delusions) despite multiple~     adequate medication trials with antipsychotic medications including clozapine. There are~     currently no available treatments for such patients who generally have poor function and are~     chronically disabled, unable to work, live independently or have meaningful social~     relationships. Neuroimaging studies in patients with schizophrenia have revealed information~     about pathological neural circuits that could be suitable targets using deep brain~     stimulation. Although not yet tested in patients with schizophrenia, DBS is in early phase~     clinical trials in other psychiatric disorders.~      This pilot study will investigate the use of DBS in treatment-resistant schizophrenia~     subjects who have exhausted all other therapeutic alternatives but continue to have~     persistent disabling psychotic symptoms. Of note, DBS is not FDA approved for use in patients~     with schizophrenia. The method will be similar to that used in subthalamic nucleus~     stimulation in patients with Parkinson's Disease. However, the electrode will be advanced~     slightly inferior into the SNr, a major outflow nucleus of the basal ganglia, with the~     intention of causing local inhibition of SNr outflow resulting in disinhibition of the~     mediodorsal nucleus (MDN) of the thalamus. Hypofunction of the MDN has been implicated in the~     pathophysiology of schizophrenia in post-mortem as well as multiple structural and functional~     imaging studies. Evidence suggests that dysfunction of the MD is implicated in both positive~     and cognitive symptoms (such as working memory impairment) in schizophrenia. Frequent~     monitoring and clinical assessment with psychiatric scales will be used to monitor treatment~     response.~   "
92106|NCT02361541|"~     Hepatitis C (HCV) is an important global public health problem, disproportionately affecting~     HIV positive populations. Asia and Africa account for most of the co-infection burden, but~     access to HCV screening and treatment is still very limited. It is expected though, with the~     recent therapeutic advances and increasing global advocacy efforts, that HCV treatment should~     become a feasible option in the near future.~      Sihanouk Hospital Center of HOPE (Phnom Penh, Cambodia) is catering for one of the largest~     HIV cohorts of the country, followed in an ambulatory settings. In this cohort, the~     prevalence of HCV co-infection will be determined, as well as HCV genotype diversity and the~     severity of liver disease. The researcher will also explore the performance of simple blood~     tests/panels as predictors of significant fibrosis and/or cirrhosis.~      Patients will attend two study-visits. All adult patients of the HIV patient cohort of SHCH~     will be proposed HCV testing during their next HIV follow-up consultation, following the~     latest algorithm of the Centre for Disease Control (CDC) (May 2013). Anamnesis and clinical~     examination will focus, additionally to routine practice, on presence of general and HCV~     liver-disease related features. Laboratory analyses will include basic HIV tests (CD4), and~     tests for liver function such as Hepatitis B surface antigen (HbsAg) .~      During the following routine HIV follow-up consultation, the results of HCV testing will be~     explained to the patient. If the patient is HCV negative, his/her study participation ends~     here. If currently infected with HCV, the clinician will repeat the HCV liver-disease~     (extra-hepatic & hepatic) related anamnesis and clinical examination, and prescribe~     additional blood tests for the non-invasive liver fibrosis/cirrhosis blood panel tests, liver~     and kidney function. Patients will moreover be asked to undergo a liver ultrasound and liver~     stiffness measurements.~   "
92133|NCT02361190|"~     The proposed study will test the effects of a fast-acting testosterone nasal spray on the~     fear reactions of young men to two distinct anxiety challenges (social and nonsocial) using a~     double-blind randomized experimental design.~   "
92107|NCT02361528|"~     The concept of acquired immunodeficiency after a first severe infection in the ICU is widely~     described in the literature. There is a dual risk: increased mortality and increased~     secondary infections. Several approaches of immunostimulatory treatments have been proposed~     in the literature. The treatment proposed by this study consists of the administration of~     Granulocyte-macrophage colony-stimulating factor (GM-CSF), colony stimulating factor widely~     used particularly in the USA where it is marketed. A phase 2 clinical trial was conducted in~     Germany in 2009.~      The main objective is to measure the incidence of ICU-acquired infections in 2 groups of~     patients treated by GM-CSF or placebo. ICU patients at risk are defined as surviving at D3~     from a severe sepsis or septic shock and presenting a sepsis associated immunodepression. The~     detection of immunosuppressed patients will be achieved by measuring the HLA-DR (Human~     Leucocyte Antigen DR)with a threshold of less to 8000 sites.~      Our hypothesis is that the number of secondary infections (primary endpoint) will be~     significantly reduced in the treated group.~   "
92108|NCT02361515|"~     The present randomized, open, multicentric Phase II trial, in parallel groups with two arms~     of treatment, compares the treatment A, moderate hypofractionated radiotherapy of 62Gy, to~     treatment B, stereotactic irradiation of 37.5 Gy with hyaluronic acid injection in the space~     between the prostate and the rectum to preserve the rectal-wall from high doses of~     irradiation. The study aims to assess the rates of late urinary toxicities of grade ≥ 2~     induced by a moderate hypofractionated radiotherapy (62Gy in 20 fractions of 3.1Gy) and by a~     stereotactic radiotherapy (37.5Gy in 5 fractions of 7.5Gy), and the rectal toxicities after~     an injection of hyaluronic acid between the rectal wall and the prostate.~      Ninety-six patients and 9 centers are included in the protocol.~   "
92109|NCT02361502|"~     The proportion of male patients who participated in the phase III study of mirabegron was~     about 28% and the data on the efficacy and safety of mirabegron in Korean male OAB patients~     have limits. For this reason, this study will assess the efficacy and safety of mirabegron in~     Korean male OAB patients.~   "
92110|NCT02361489|"~     The aim of the study is to observe patients with Type 2 Diabetes on basal insulin alone or~     basal insulin with oral agents can be efficiently and safely started with meal time insulin~     using U100 rapid acting insulin analog and V-Go® Disposable Insulin Delivery Device (V-Go)~     using one of two dose titration algorithms to achieve improved A1C at 4 months.~   "
92111|NCT02361476|"~     Clonidine is widely used off-label in children for several indications. Clonidine is used for~     treatment and/or prevention of postoperative agitation in children anaesthetised with~     Sevoflurane. The investigators don´t have solid evidence for the effect and the investigators~     don´t have data for characterization of the pharmacokinetic profile among age-groups for~     children 1-6 years.~      In this study the investigators want to investigate if IV Clonidine administered at the end~     of surgery can prevent/reduce postoperative agitation. Secondary outcomes include~     measurements of postoperative pain relief and adverse effects, including a 30-day follow-up.~   "
92112|NCT02361463|"~     Laparoscopy training programs with virtual reality simulators are widely used before new~     surgeons are allowed to operate on patients. Laparoscopic surgery results in shorter time to~     recover, less surgical trauma and thereby a shorter stay at the hospital compared with open~     surgery. However, it is more difficult to learn laparoscopic surgery, than open surgery, in~     part because surgeons have to work in a 3-dimensional space, through a 2-dimensional~     interface on a screen. This results in loss of depth perception and therefore a higher visual~     and cognitive load. This trial examines if using 3D vision instead of 2D vision on the~     laparoscopic virtual reality simulator reduces the time to reach proficiency, by decreasing~     the cognitive and visual load during practice on a Virtual Reality Simulator.~   "
92113|NCT02361450|"~     Spina Bifida is a developmental congenital disorder caused by the incomplete closing of the~     embryonic neural tube, leading to serious malformations of the nervous system. Caudal~     neuropore malformations almost always lead to sensory-motor deficits (including complete~     paraplegia) with orthopedic deformations, pressure sores, and pelvic/perineal neurological~     dysfunctions (affecting the bladder-sphincter, anorectal, and genital sphere).~      The purpose of the study is to assess the efficacy of retrograde colonic irrigation~     associated with usual care (medical treatments, patient education) on anorectal dysfunction~     (incontinence and/or constipation), compared to usual care only.~   "
92114|NCT02361437|"~     This study is designed to evaluate if Vasculera, a marketed medical food product, will~     improve the rate and extent of healing of diabetic ulcers.~   "
92115|NCT02361424|"~     The purpose of this study is to assess the safety and efficacy on cognitive impairment and~     functioning of several doses of PXT00864 (new fixed combination of acamprosate and baclofen~     at low dose) in patients with mild Alzheimer Disease.~   "
92116|NCT02361411|"~     The purpose of this study is to~        1. Early identify patients based on clinical manifestation, imaging, gene and histology,~          explore diagnostic tools~        2. get gene repertoire of Chinese~        3. Build a cerebral amyloid angiopathy (CAA) prospective cohorts, observing the disease~          history, and exploring prognostic factors of hemorrhage in CAA patients~   "
92117|NCT02361398|"~     The investigators conducted a pilot study to compare the effect of Positive End Expiratory~     Pressure(PEEP) setting guide by the highest on oxygenation and by lung electrical impedance~     tomography(EIT) on survival in subjects with severe Acute Respiratory Distress~     Syndrome(ARDS).~   "
92118|NCT02361385|"~     The importance of the detection of early inflammatory arthritis is recognised as being~     essential to the prevention of permanent joint damage. Furthermore, drug development in~     inflammatory arthritis is in increasing need of imaging that is able to sensitively and~     accurately detect and quantify inflammation in a reproducible and objective manner. There is~     an increasing body of evidence to support the role of PET-CT for these indications. The PET~     tracer 11CPBR28 is specific to the translocator protein (TSPO) highly expressed on activated~     macrophages. In this proof of principle study, the investigators aim to ascertain whether or~     not the PET tracer 11CPBR28 is taken up in inflamed joints. The investigators also aim to~     explore the significance of TSPO to inflammatory arthritis, through blood and joint lining~     samples.~   "
92134|NCT02361177|"~     The investigators are interested in the impact of intranasal oxytocin in unethical behavior.~   "
92135|NCT02361164|"~     The primary objectives are to evaluate relationship between nasopharyngeal microbial~     colonization and the occurrence of AOM or pneumonia in infants.~   "
92119|NCT02361372|"~     In a controlled, parallel, double-blind intervention study over 6 months, the investigators~     investigated the effects of kefir-fermented milk (1,600 mg/kg) supplemented with calcium~     bicarbonate (CaCO3, 1,500 mg/kg) and bone metabolism in 40 osteoporosis patients, and~     compared them with CaCO3 alone without kefir supplements. Bone turnover markers were measured~     in fasting blood samples collected before therapy and at 1, 3, and 6 months. BMD values at~     the spine, total hip, and hip femoral neck were assessed by dual-energy x-ray absorptiometry~     (DXA) at baseline and at 6 months.~   "
92120|NCT02361359|"~     Psychologic status is associated with poor outcome after joint arthroplasty and perhaps~     chronic pain. To enhance the therapeutic effect of a psychologic intervention, the specific~     disorders or pain-related beliefs that contributed to chronic pain should be identified. We~     therefore determined whether specific psychologic disorders (depression, anxiety disorder) or~     health-related beliefs (self-efficacy, pain catastrophizing) are associated with chronic pain~     after joint arthroplasty for osteoarthritis.~   "
92121|NCT02361346|"~     This Phase I, multiple ascending dose study will seek to enroll subjects with progressive B~     cell non-Hodgkin's lymphoma with measurable disease (lesion > 1.5 cm) (including SLL) OR~     relapsed/refractory B-cell CLL who have received standard treatment with at least one~     anti-CD20 antibody (e.g.; rituximab, ofatumumab)) containing front-line regimen that resulted~     in initial response, followed by relapse/recurrence and who are not eligible for any further~     approved biologic therapy, chemotherapy and/or autologous stem transplantation and/or refuse~     alternative approved therapies and/or are unlikely to achieve clinical benefit from any~     therapy of higher priority by Investigator assessment.~   "
92122|NCT02361333|"~     The purpose of this study is to determine whether a teaching intervention can help increase~     the use of remote monitors in patients with implantable cardioverter defibrillators.~   "
92123|NCT02361320|"~     The goal of this study is to learn if computed tomography (CT) scans can help researchers~     predict how patients with pancreatic cancer may respond to chemotherapy.~      This is an investigational study. The CT scans are performed using FDA-approved and~     commercially available methods.~      Up to 259 patients will take part in this study. All will be enrolled at MD Anderson.~   "
92124|NCT02361307|"~     The outcomes of ADL training in stroke patients depend on multifactors and essential~     practical point is cooperation plus effective communication between occupational therapist~     and nurse.~   "
92125|NCT02361294|"~     The study is designed to evaluate the role of platelets and immature platelets in the~     ethiopathology of deep venous thrombosis and pulmonary embolism.~   "
92126|NCT02361281|"~     Sarcoidosis is a chronic lung disease that is characterized by fatigue, shortness of breath,~     chest pain and reduced lung function. Suffering from these diseases has a very negative~     effect on the quality of life. When people are suspected of having sarcoidosis various~     markers in the blood are measured. Ultimate diagnosis, however, always requires invasive~     techniques such as bronchoscopy and lung biopsy. Consequently, there is an urgent need for a~     new diagnostic tool that is easy, quick and most of all non-invasive and thus friendly for~     the patient.~      Such a new diagnostic tool might be found in examining the exhaled air of patients, which~     contains a complex mixture of so-called volatile organic compounds (VOCs) that are the result~     of damaging processes that occur in the lung. Determining the VOC profile in the breath can~     be used as a biomarker, or biological indicator, of those damaging processes. In other words,~     searching for unique VOC profiles in the breath of sarcoidosis patients might lead to the~     development of a diagnostic tool that only uses their exhaled breath.~      The current study involves 25 sarcoidosis patients and 25 healthy volunteers. The aim of this~     study is find VOCs in exhaled air that can be used to diagnose sarcoidosis. In a previous~     study, sarcoidosis-specific VOCs were found, which we intend to validate using the current~     study.~   "
92127|NCT02361268|"~     The purpose of this study is to compare the effects of intra-dialysis yoga to an educational~     program among patients with end-stage renal disease. The investigators hypothesize that yoga~     as compared to the educational program will significantly improve quality of life.~   "
92128|NCT02361255|"~     Parkinson's disease (PD) and Drug-induced Parkinsonism (DIP) can be clinically~     indistinguishable and DIP sometimes represents unmasking of underlying PD. The objective of~     this study is to determine the relationship of underlying Parkinson's disease (PD) to the~     incidence and clinical outcome in DIP using non-motor assessments as a marker for~     nigrostriatal degeneration.~      Research Design: This is a nested case-control design to investigate risk factors associated~     with the development of DIP and persistent Parkinsonism after antipsychotic (AP) withdrawal~     (a potential clinical marker of underlying PD). Target enrollment is 45 subjects.~      Methodology: We will examine objective olfactory function (via objective olfactory testing),~     other non-motor symptoms of PD (via standardized validated questionnaires), and motor~     findings (via clinical exam and quantitative gait analysis) in: 1) DIP patients (30 subjects)~     compared to AP-treated patients without Parkinsonism (15 subjects) and 2) patients with~     persistent Parkinsonism compared to those whose symptoms resolve in the DIP cohort followed~     prospectively after a change in AP treatment. Additionally, in patients where it was~     performed clinically, we will evaluate dopamine transporter SPECT imaging (DaTI) as a marker~     of nigrostriatal integrity examining the ability of qualitative and semi-quantitative~     analysis to distinguish between pharmacologic and degenerative Parkinsonism. We will also~     measure serum uric acid and Apolipoprotein A1, two putative biomarkers in early PD, and~     examine their relationship with clinical and radiologic status.~   "
92129|NCT02361242|"~     PLEODIAL-II study is an extension of the previous pilot PLEODIAL-I study (CLN-PXT00864-03~     protocol) and is designed for the descriptive analysis of patients with mild AD who are~     exposed to PXT00864 over an additional 24-week period.~   "
92130|NCT02361229|"~     It's known that organ transplant recipients with long-term drug-induced immunosuppression~     have a increase of the life-time incidence of squamous cell carcinoma. This study will~     analyze the incidence and type of skin cancer in the Swiss Transplant Cohort Study and the~     association with exposure to immunosuppressive and antiinfective drugs and other parameters~     like age or gender of organ transplant recipients.~   "
92131|NCT02361216|"~     The objective of the trial is to investigate efficacy and safety of ingenol mebutate gel for~     actinic keratosis applied to large treatment areas once daily for three consecutive days on~     face, scalp or chest.~   "
92169|NCT02360722|"~     This is a single- country, interventional, double-arm study involving Chinese Elderly~     subjects.~   "
92136|NCT02361151|"~     The high rates of childhood obesity in the US demand innovative and cost-effective weight~     gain prevention tools; mobile applications (apps) represent one such solution. Using a~     randomized design, the mFIT study tests the effectiveness of using commercially available~     apps and a physical activity (PA) monitoring device (Tech, n=50 parent-child dyads) compared~     to the apps and PA device plus a mobile website and theory-based family intervention that~     encourages increased parent-child communication about PA and healthy eating as well as family~     behavior change (Tech+, n=50 parent-child dyads).~   "
92137|NCT02361138|"~     SHR3824 is a novel inhibitor of renal sodium-glucose cotransporter 2, allows an~     insulin-independent approach to improve type 2 diabetes hyperglycemia. In this multiple-dose~     study the investigators evaluated the safety, tolerability and PK/PD profiles of SHR3824 in~     healthy subjects.~   "
92138|NCT02361125|"~     The goal of this clinical research study is to evaluate the effectiveness of ritalin~     (methylphenidate) taken on an as needed basis for the management of cancer related fatigue.~     The effects of methylphenidate on pain, mood, and sedation will be evaluated. Researchers~     will also evaluate the level of fatigue throughout the day and any possible causes of~     fatigue.~   "
92139|NCT02361112|"~     Pyrotinib is an oral tyrosine kinase inhibitor targeting both EGFR and HER-2 receptors. This~     study is designed to evaluate the safety and tolerability of Pyrotinib in combination with~     capecitabine in patients with HER2 positive metastatic breast cancer:~      To evaluate the safety and tolerability of pyrotinib, and the maximum tolerated dose (MTD) To~     determine the dose-limiting toxicity (DLT) To determine the pharmacokinetic profile of~     Pyrotinib To assess preliminary antitumor activity To determine preliminary regimen dose for~     phase II study~   "
92140|NCT02361099|"~     This is a study that evaluates an optimization of the monitoring of patients with lung cancer~     in order to extend the survival of patients by improving their quality of life and decreasing~     anxiety generated by the achievement of balance sheets imaging. The spacing of the follow-up~     imaging also helps to reduce the cost of such monitoring. The main objective of this study is~     to evaluate the overall survival of patients.~   "
92141|NCT02361086|"~     The goal of this clinical study is to determine the safety, tolerability, pharmacokinetics~     and activity of once-daily (QD) oral dosing of VT-464, a lyase-selective inhibitor of CYP17,~     in patients with castration-resistant prostate cancer (CRPC).~   "
92142|NCT02361073|"~     The event-related potentials may be different in patients with Takotsubo cardiomyopathy than~     in patients without Takotsubo.~   "
92143|NCT02361060|"~     Pulmonary complications are relatively frequent after surgery, and can be associated with an~     increase in morbidity and mortality. Although there are several causative mechanisms that can~     lead to postoperative pulmonary complications, alterations in the shape and motion of the~     chest wall are of primary importance.~      In the investigator´s institution the incidence of postoperatory hypoxemia defined as~     pO2/FiO2 <300 is over 20% for patients after major abdominal surgery.~      Observational and randomized clinical trials have demonstrated that incomplete neuromuscular~     recovery during the early postoperative period may result in acute respiratory events~     (hypoxemia and airway obstruction) and an increased risk of postoperative pulmonary~     complications.~      A recent study in laparoscopic bariatric surgery showed that patients in which neuromuscular~     block reversal was done with sugammadex had less chest X-ray pathological changes than those~     from an historical cohort reversed with neostigmine.~      The hypothesis is that differences in pulmonary complications, as atelectasis and hypoxemia,~     between patients reverted with sugammadex or neostigmine may be more apparent with more~     sensitive techniques like spirometry or lung ultrasound when they exist.~      Lung ultrasound (LUS) has demonstrated a sensitivity of 90% and a specificity of 98%, to~     detect alveolar consolidation in critical ill patients while chest radiography data are known~     to be imprecise.The investigator would like to explore the utility of LUS in postsurgical~     patients and the relationship between degree of hypoxemia and consolidation area.~      Objectives:~        1. Primary: Forced vital capacity decreases after surgery. This reduction may be relieved~          in the absence of residual neuromuscular block. Objective is to assess differences after~          reversal with neostigmine versus sugammadex in:~           • Forced vital capacity (FVC)~        2. Secondary objectives: To assess differences after reversal with neostigmine versus~          sugammadex in:~             -  Atelectasis size determined by lung ultrasound (Plannimetry)~             -  pO2/FiO2 <300 1 hour after surgery~             -  Explore the accuracy of lung ultrasound (LUS) to diagnosis postoperative~               atelectasis and its correlation with chest Xray, FVC and pO2/FiO2.~      Hypotheses:~        1. Sugammadex NMB reversal results in a lower reduction of forced vital capacity (FVC) as~          compared to NMB reversal with neostigmine.~        2. Atelectasis is common after major surgery. Size of atelectasis determined by lung~          ultrasound planimetry is lower one hour after sugammadex reversal as compared to the~          neostigmine group.~        3. The incidence of post-surgical hypoxemia is lower in the sugammadex group as compared to~          the neostigmine group (Hypoxemia defined as pO2/FiO2 less than 300 is expected in 20% of~          patients after major abdominal surgery).~        4. Lung ultrasound has a better capacity to detect alveolar consolidation than Chest Xray~          after major surgery.~        5. Atelectasis size determine by planimetry has a good correlation with pO2/FiO2 and~          decrease of FVC after surgery~   "
92144|NCT02361047|"~     This pilot study will evaluate the feasibility, acceptability, and potential efficacy of a~     parent-targeted, phone-based program to prevent unhealthy weight gain and improve biomarkers~     of oxidative stress and inflammation among childhood acute lymphoblastic leukemia survivors.~   "
92145|NCT02361034|"~     This is a multiple Ascending dose (MAD) study with GRC 27864 in Healthy and Elderly Subjects.~   "
92146|NCT02361021|"~     Evaluation of lung aeration during weaning from mechanical ventilation determined by~     electrical impedance tomography and lung ultrasound~   "
92147|NCT02361008|"~     The purpose of this study is to investigate the security and validity of transesophageal~     echocardiography(TEE)-guided perventricular device closure(TPDC) through minithoracotomy in~     treatment of infundibular ventricular septal defect(IVSD) with asymmetric occluder.~   "
92148|NCT02360995|"~     The objective of this clinical research study is to evaluate clinical efficacy of Colgate~     Total Toothpaste as compared to Crest Pro-Health Toothpaste and Crest Pro-Health Mouthwash,~     and Crest Cavity Protection Toothpaste and Crest Fluoride Mouthwash in reducing gingivitis~     and dental plaque in adults in a six-week clinical study.~   "
92149|NCT02360982|"~     The aim of this study is to compare the risk factors and the incidence of delirium following~     orthopedic surgery under the general or regional anesthesia in elderly patients.~   "
92170|NCT02360709|"~     The purpose of this study is to evaluate the safety, efficacy and deliverability of the CRE8~     sirolimus-eluting stent system in the treatment of patients with de novo coronary artery~     lesions.~   "
92190|NCT02360449|"~     The purpose of this study is to investigate whether a social initiation motivation~     intervention (SIMI) focused on training children with ASD to initiate to peers during~     structured play activities will result in more frequent initiations to typically developing~     peers during free play. The SIMI approach under investigation uses behavioral strategies~     based in Applied Behavior Analysis and Pivotal Response Treatment to motivate children with~     ASD to initiate to peers. Children with ASD will be randomly assigned to either the SIMI or a~     waiting list. Treatment will be provided for 8 weeks in the context of a weekly social skills~     group.~   "
92191|NCT02360436|"~     Analyis of the Glutathione Cycle in Children with Rett Syndrome~   "
92192|NCT02360423|"~     The purpose of this study is to evaluate the safety, efficacy and deliverability of the CRE8~     sirolimus-eluting stent and the RESOLUTE zotarolimus-eluting stent in the treatment of~     patients with de novo coronary artery lesions.~   "
92150|NCT02360969|"~     Strabismus is a common condition (4-6% of the population) . The screening and treatment is a~     public health issue. Indeed, beyond the disfigurement, this disease is very supplier of~     amblyopia which is definitive if it is not detected and treated early (before 6 years old).~      Initial treatment of strabismus is medical with orthoptic reeducation through penalization of~     the better eye in case of amblyopia or wearing optical correction in case of associated~     refractive disorder.~      The second step is the treatment of strabismus is the surgery, when medical treatment has not~     resulted in a recovery of the visual axes. The principle of surgery is to weaken or~     strengthen one or more extraocular muscles of one (or two) eye to correct the eyes squint~     deviation. The main difficulty of surgical treatment is to assess the amount of strengthening~     or weakening muscles to do in order to obtain the best result and for a long time.~      The investigators know that the postmortem anatomical position of the eyes is generally a~     slight elevation and divergence, but is inferior to the angle of divergence of the orbital~     axes. Curare and similar products which inhibit the nervous transmission at the neuromuscular~     junction, can be used to reproduce this situation in normal subjects.~      The sign of general anesthesia is then to evaluate the angle of strabismus when the patient~     is under deep general anesthesia and with a complete muscle relaxation, obtained only when~     curarised it. If one or both eyes are recovering under general anesthesia, strabismus is~     mainly due to dynamic changes and surgery limiting muscle play (wire operation) and sometimes~     one eye is justified. A combination of both is possible (down + wireless), guided by the~     importance of the sign of general anesthesia on two prominent eyes or one eye. This sign of~     general anesthesia is however less known and most poorly quantified in healthy subjects. Yet~     it seems very important to determine what is deviation in normal subjects after neuromuscular~     blockade, as his eye movement is also subject to mechanical factors and spastic. This would~     indicate whether the state of rectitude (no strabismus) is the result of a deviation at~     complete rest (appearing under general anesthesia) and corrected by spastic elements~     wakefulness or, in another case this righteousness is already present in the state of general~     anesthesia (due to static factors) and slightly modified by enlightenment.~   "
92151|NCT02360956|"~     The purpose of this study is to determine whether olmesartan medoxomil is effective in the~     treatment of coronary atherosclerosis progression and epicardial adipose tissue(EAT) volume~     reduction in patients with coronary atherosclerosis detected by coronary CT~     angiography(CCTA).~   "
92152|NCT02360943|"~     The treatment of the venous thromboembolic disease, including pulmonary embolism (PE), is~     based on anticoagulants. During the last decade, all the randomized clinical trials~     evaluating these anticoagulants have included PE patients with an average age below 60 years.~     But in clinical pratice, approximately 50% of PE patients are older than 75 years.~      So the investigators want to perform a french multicentre prospective cohort of consecutive~     patients receiving an anticoagulant treatment for a symptomatic and confirmed PE. All the~     validated and available anticoagulant treatments are authorized in this cohort~     (unfractionnated and low molecular weight heparins, fondaparinux, vitamin K antagonists and~     direct oral anticoagulants).~      This cohort will provide data regarding the bleeding risk and the risk of PE recurrences and~     regarding the pharmacokinetic (PK) and pharmacodynamic (PD) properties of these~     anticoagulants in this older population. Using population approach modelling , the~     investigators will pay particular attention to the sources of PK/PD variability PK / PD such~     as genetic polymorphisms of P-glycoprotein and cytochrome P450.~      Using all these data , the investigators will try to identify significant risk factors for~     bleeding and venous thromboembolic events.~   "
92153|NCT02360930|"~     The trial is to determine if a difference exists in the way that adolescents and young adults~     metabolize the chemotherapy agent vincristine compared to younger children.~   "
92154|NCT02360917|"~     At Cedars-Sinai Medical Center, we have developed a novel curriculum for a 6-week~     psycho-educationally-based, cognitive behavioral program to help patients with subjective~     cognitive complaints after cancer treatment, titled Emerging from the Haze™ (Haze). Each~     series meets once a week for 2 hours for 6 weeks. The leading neuropsychologist covers~     material such as guided relaxation, behavioral strategies for automatic/negative thoughts,~     compensatory strategies for attention and memory, executive functioning, pacing, and balance.~     Each Haze series will be electronically delivered in a live format to our satellite site, The~     University of Kansas.~   "
92155|NCT02360904|"~     The primary aim of this study is to assess and compare change in QOL during chemotherapy as~     measured by the Functional Assessment of Cancer Therapy-Breast (FACT-Breast) score between~     patients receiving yoga and those not receiving yoga. Secondary endpoints will include other~     measures of QOL such as sleep quality measured with the Pittsburg Sleep Quality Inventory~     (PSQI), anxiety and depression using Hospital Anxiety and Depression Scale (HADS), and~     adherence to yoga and to chemotherapy treatment.~   "
92156|NCT02360891|"~     Amyotrophic lateral sclerosis (ALS) is a complex polymorph and devastating neurodegenerative~     disease. Although the pathophysiological mechanisms underlying the development of ALS remain~     to be fully elucidated, there have been significant advances in the understanding of ALS~     pathogenesis, with evidence emerging of a complex interaction between genetic factors and~     dysfunction of vital molecular pathways. However, the numerous randomized clinical trials~     (RCT) for ALS have failed to generate improved drug treatments. Biomarkers able to bring~     prognostic value and to distinguish the different endophenotypes of this polymorphic disease~     could help to better select clusters of patients in order to improve the RCT outcomes.~     However, little progress has been made in the development of viable diagnostic, prognostic~     and monitoring markers. This could be explained by common shortcomings, such as relatively~     small sample sizes, statistically underpowered study designs, lack of disease controls and~     poorly characterized patient cohorts. It is yet crucial that the investigators further~     develop and validate ALS biomarkers and incorporate these biomarkers into the drug~     development pipeline for ALS.~      The aim of the present study is therefore to determine the clinical, biological, imaging, and~     electrophysiological biomarkers of prognosis of survival without events (i.e. severe~     comorbidity, 24 hours of non invasive ventilation, tracheotomy). This is a prospective~     observational multicentric French study of a cohort of 1000 ALS patients.~      This large multimodal database will be open for international fruitful scientific~     collaborations.~   "
92157|NCT02360878|"~     We want to evaluate the impact of the EndoBarrier Gastrointestinal Liner (DJBS) on glucose~     metabolism as well as gut and pancreatic hormone secretion.~   "
92179|NCT02360592|"~     This study is a multi-center, randomized, prospective, open-label Phase IV Clinical trial to~     evaluate efficacy and safety of interferon alfa-2b therapy combinated with interleukin 2 and~     hepatitis B therapeutic vaccine versus interferon alfa-2b alone in chronic hepatitis B~     patients with entecavir achieving HBeAg seroclearance. Patients were randomized to one of 3~     groups to receive different antiviral treatment.~   "
92180|NCT02360579|"~     Prospective, interventional multicenter study evaluating adoptive cell therapy (ACT) with~     autologous TIL infusion (LN-144) followed by interleukin 2 (IL-2) after a nonmyeloablative~     lymphodepletion (NMA-LD) preparative regimen.~   "
92158|NCT02360865|"~     1: Is endothelium function impaired in COPD? Other chronic cardiovascular diseases are~     associated with endothelial dysfunction, and the endothelium plays an important role in~     regulating vascular tone, tissue blood flow, coagulation and the inflammation process.~     Although the specific causes of endothelial dysfunction remain unclear, physical inactivity,~     chronic systemic inflammation and smoking are all known to be associated with endothelial~     abnormality.~      2. Is Muscular Sympathetic Nerve Activity (MSNA) increased in COPD? A balanced regulation of~     blood flow to skeletal muscles may be disturbed by pathophysiology and may therefore~     contribute to the exercise intolerance and skeletal muscle depletion seen in patients with~     COPD.Skeletal muscle blood flow is tightly regulated to match tissue oxygen demands and is~     thus adapted to meet energy requirements. During physical activity, the sympathetic nervous~     system is activated (exercise pressor reflex), resulting in increased ventilation, heart~     rate and a redistribution of cardiac output from inactive to active tissues. The~     redistribution of cardiac output to the body organs is heterogeneous. Blood flow to skeletal,~     respiratory and cardiac muscle increases as exercise intensity increases, whereas blood flow~     to gastrointestinal, renal and reproductive tissues decreases. As blood pressure during~     exercise remains largely unchanged, the redistribution of blood flow is caused by changes in~     vascular conductance. These conductance changes are caused by an overall vasoconstriction~     induced by the increased sympathetic outflow of noradrenaline (NA), and a vasodilation of~     vascular beds supplying the working skeletal -, cardiac- and respiratory muscle.~   "
92159|NCT02360852|"~     This study will evaluate the safety, tolerability and influence on itching, bile acids and~     liver enzyme changes in patients with PBC (Primary Biliary Cirrhosis) treated with A4250~   "
92160|NCT02360839|"~     Endoscopic ultrasound (EUS) with fine needle aspiration (FNA) for cytology and/or fine needle~     biopsy (FNB) for histology may be used in the diagnostic work-up of intrathoracic and~     intrabdominal lesion of unknown origin. Certain lesions (such as pancreatic adenocarcinoma)~     are often well characterized by cytology assessment of FNA-samples while others are not (such~     as GIST-tumors).~      This study is a part observational (early study phase) and part interventional study (late~     study phase) on the diagnostic accuracy of EUS-assisted tissue sampling by FNA or FNB during~     a 10-year period on a tertiary endoscopy centre.~   "
92161|NCT02360826|"~     Anticipating an increased use of statins in children and adolescents, it is imperative that~     we understand the genetic and developmental characteristics affecting the pharmacokinetics~     and pharmacodynamics of statins in childhood and adolescence. Simply extrapolating pediatric~     dosing guidelines from adult dose-exposure-response relationships fails to recognize the~     potential impact of growth and development in pediatric patients, which may have important~     clinical implications for drug efficacy or toxicity. Current evidence indicates that genetic~     variation in the SLCO1B1 transporter is important for statin disposition and toxicity in~     adults. The ontogeny of SLCO1B1 during human growth and development has not been well~     characterized, and limited pediatric data indicate that the genotype-phenotype relationship~     in children is the opposite of that observed in adults. Therefore, investigating the relative~     roles of SLCO1B1 ontogeny and genetic variation in statin disposition and response is key to~     determining the age at which the statin dose-exposure-response relationship mimics adults,~     and has important implications for other medications transported by the SLCO1B1 protein.~      As the first step in this process, our specific aims for the current investigation are 1) to~     determine the effect of genetic variation of SLCO1B1 on the pharmacokinetics of pravastatin~     and simvastatin by comparing Cmax, AUC and elimination between children and adolescents with~     2 functional SLCO1B1 alleles and those with one or more variant alleles, and 2) to determine~     if the magnitude of the genetic effect on pravastatin pharmacokinetics (defined as Cmax, AUC~     and elimination) is equivalent to the effect on simvastatin pharmacokinetics. As a secondary~     aim, Cmax and AUC of pravastatin and simvastatin will be compared between children and~     adolescents for each genotype group. These results will be utilized to determine the sample~     size necessary to adequately power future studies characterizing the role of ontogeny on~     statin disposition.~      The ultimate goal of this proposed investigation is to establish the role of genetic~     variation in key transporters on the dose-exposure relationship of two commonly used statin~     drugs in children. This study is the first step in a series of investigations aimed at~     determining the mechanisms behind variations in physiologic response, clinical efficacy and~     significant adverse effect risk that surround the statin drugs in children and adolescents.~   "
92162|NCT02360813|"~     This clinical trial tests the feasibility, effectiveness and patient satisfaction with~     cognitive remediation therapy for patients diagnosed with schizophrenia or schizoaffective~     disorder within a forensic hospital. It is hypothesised that patients receiving cognitive~     remediation therapy will have an improvement in cognitive performance, real world~     functioning, symptoms, violence risk and benefit more from additional psychosocial treatment~     programmes over time relative to patients receiving treatment as usual. Furthermore it is~     hypothesised that it will be feasible to carry out such a study and that patients will report~     high rates of satisfaction with cognitive remediation therapy. Finally it is hypothesised~     that differences on the effectiveness measures will be maintained at 6 month follow up after~     the end of treatment.~   "
92163|NCT02360800|"~     Bleeding after redo cardiac surgery is a common, unresolved and consequences-heavy event as~     per present day. Tisseel (Baxter inc) sprayed on the already hemostased mediastinum jut~     before closing seems a promising technique to radically diminish bleeding.~      This study aims to verify this efficacy volume in chest drains) and possibly the consensual~     blood transfusion lessening.~   "
92164|NCT02360787|"~     The purpose of this study is to determine whether inclusion of almonds in a weight loss~     regimen will augment the rate of weight loss, promote a greater fat mass/fat-free mass ratio~     of weight loss, improve blood pressure and ameliorate the post-lunch dip in cognitive~     function.~   "
92165|NCT02360774|"~     The purpose of this study is to investigate the effect of canagliflozin, a medication~     approved by the FDA for the treatment of type 2 diabetes, on body weight and metabolism in~     people with type 2 diabetes who are overweight or obese.~      Canagliflozin lowers glucose levels in the blood by making the kidneys excrete, rather than~     absorb, glucose. Canagliflozin is also often associated with weight loss.~      The study population will generally be type 2 diabetics, ages 18-75 years old, who are~     overweight or obese.~   "
92166|NCT02360761|"~     The role of sublobar resection(Wedge resection or anatomic segmentectomy) for small(≤ 2cm)~     early stage non-small cell lung cancer has been studied by Lung Cancer Study Group and is~     being studied by several ongoing trials. However, elderly patients(aged ≥70 years) in these~     trials is under-represented, as in most of the ongoing clinical trials. This study focuses on~     the elderly population of early stage lung cancer, and aims to investigate the outcome of~     lobectomy versus sublobar resection for peripheral stage I non-small cell lung cancer (NSCLC)~     in elderly patients.~   "
92167|NCT02360748|"~     The study proposes that addition of high protein plant based diet will improve serum albumin~     as well serum phosphate for patients with End Stage Renal Disease (ESRD) on Dialysis. Patient~     will be provided additional food items to help improve their nutritional status.~   "
92168|NCT02360735|"~     Manual Lymphatic Drainage (MLD) is a specialized massage technique utilized to decrease~     various forms of edema. This technique promotes reuptake of interstitial fluid along the~     pathways of the lymphatic system. This technique promotes healing, decrease swelling, and~     decrease pain.~   "
92171|NCT02360696|"~     Duodenal eosinophilia has been associated with dyspepsia in adults and the investigators have~     previously described the finding of duodenal mucosal eosinophilia in 71-79% of children~     undergoing diagnostic endoscopy. Previous studies in children have shown positive response to~     montelukast with approximately 50% finding complete relief and 20-30 percent showing no~     response.~      There are a number of factors that have the potential to contribute to the observed~     variability in response to montelukast. These include variability in:~        1. systemic drug exposure (drug absorption, biotransformation and/or elimination)~        2. regulation of leukotriene biosynthesis~        3. cysteinyl leukotriene receptors and downstream mediators~        4. patient disease phenotype (e.g. Functional Gastrointestinal Disorder (FGID) disease~          classification, psychologic profile)~      In this study, the investigators propose to utilize biopsy specimens stratified by drug~     response to identify candidate gene expression modules that will be validated in a~     prospective study design. The overall goal of this program is to develop a signature of~     montelukast response that can be applied not only to eosinophilic gastroenteritis, but more~     generally to other diseases, such as asthma, where the drug is widely used with variable~     success.~   "
92172|NCT02360683|"~     This study identify preoperative predictors of response to subthalamic stimulation at 1 year,~     3 years and 5 years in terms of quality of life, from a broad prospective multicenter study~     French with standardized collection of clinical data , imaging and genetic .~      The investigators want to identify factors that predict the improvement of quality of life~     for one year corresponding to a decrease of PDQ39 score of at least 20 %. They believe that~     improvement would be less likely to become zero to 3 or 5 years and question the indication~     of the subthalamic stimulation (risks and costs). This is part of a process of~     personalization of the therapeutic care that is of any interest to the subthalamic~     stimulation. It is a therapeutic option that could be dangerous if patient selection is not~     optimal , and expensive, if the benefit is not large enough to reduce the number of~     medications and hospitalizations medium term . In addition, it will quantify the improvement~     of quality of life in the longer term and harmonize national assessments .~   "
92173|NCT02360670|"~     Stroke affects over 125,000 people each year in the UK and leaves at least 50% disabled.~     Treatment of stroke caused by a blockage in a blood vessel (ischaemic stroke), with~     clotbusting drugs improves the chances of good recovery, but must be given within 4.5 hours~     of onset. Currently only a small proportion of patients who arrive in hospital within 4.5~     hours are treated. This is largely due to uncertainty about diagnosis and concerns about risk~     of bleeding associated with clotbusting medication. Patients with mild or improving symptoms~     in particular are often not treated because of uncertainty about relative risks and benefits.~     However, around one third of these patients go on to be significantly disabled. Routine CT~     scanning often does not show abnormalities in acute stroke (which take hours to become easily~     visible), and cannot show the extent or severity of blood flow changes in ischemic stroke.~      We wish to investigate the value of additional CT scanning that gives information on the~     blood vessels (angiography, CTA) and blood flow to the brain (perfusion, CTP) by undertaking~     a randomised trial. Extra scans are done in the same scanner and involve some extra~     radiation, injections of a contrast dye, and some extra time to acquire process and~     interpret. The extra scans may allow better treatment decisions for patients by increasing~     diagnostic certainty and by better assessment of stroke severity. However, we do not know~     whether the potential gains from better selection justify the resources and potential~     treatment delays that are involved. We will investigate whether the proportion of patients~     given clotbusting drugs differs between the two scanning protocols; and whether the outcomes~     differ, using standard measures of disability. We will also investigate whether use of~     different scanner manufacturers' software affect interpretation of scans.~   "
92174|NCT02360657|"~     The purpose of this study is to determine the safety, tolerability and effect of JNJ-54861911~     on level of amyloid-beta in Cerebrospinal Fluid (CSF) and plasma following 4 weeks of~     treatment in Japanese participants asymptomatic at risk for Alzheimer Dementia (ARAD) at the~     intended target dose range.~   "
92175|NCT02360644|"~     This study investigates the effect of vitamin D deficiency on drug metabolism and transport~     in patients with chronic kidney disease (CKD) and in healthy controls.~      The central hypothesis is that vitamin D concentrations independently affect metabolism and~     transport function in CKD patients. An over-arching goal of this proposal is to make drug~     therapies safer and more effective to reduce the significant morbidity and mortality in~     patients with CKD.~   "
92176|NCT02360631|"~     The purpose of this study is to examine whether or not providing Chantix (varenicline) will~     help African American smokers quit smoking.~   "
92177|NCT02360618|"~     A single arm, single center window of opportunity trial of using a combination of metformin~     and simvastatin as a neoadjuvant treatment for patients with invasive bladder cancer who are~     to undergo cystectomy. The study will assess the feasibility of conducting window of~     opportunity trials in invasive bladder cancer the drug combination's affects on a variety of~     important clinicopathologic variables.~      The goal is to enroll 44 patients within 18 months. An interim analysis will be conducted at~     12 months, and the study will be prematurely closed if fewer than 10 patients have been~     enrolled at that time. Patients will be administered 850mg of metformin twice daily along~     with 20mg of Simvastatin. Patients will be enrolled following the formal diagnosis of~     invasive bladder cancer or at first visit following referral to the London Health Sciences~     Center (LHSC). Patient's will receive metformin and simvastatin from the time of enrollment~     until the night prior to their operation in the absence of safety or tolerability concerns.~   "
92178|NCT02360605|"~     In the proposed project the investigators will evaluate two different follow-up approaches to~     improve low income patients' completion of initial and annual colorectal cancer (CRC)~     screening using the Fecal Immunochemical Test (FIT), the most sensitive FOBT. The purpose of~     this study is to compare the effectiveness of two distinct follow-up strategies to promote~     CRC screening: a prevention coordinator (PC) approach vs. an automated telephone reminder~     (ATR) system. The investigators will adapt a successful intervention tested in the Health~     Literacy and Cancer Screening Project by adding a follow-up strategy to the health literacy~     intervention. Specific Aims: The investigators Primary Aims are to: 1. Compare the~     effectiveness of the PC and ATR strategies to improve initial and repeat CRC screening. 2.~     Compare the cost effectiveness of the PC and ATR strategies for initial and repeat CRC~     screening. The investigators Secondary Aims are to: 3. Conduct a process evaluation of both~     follow-up strategies to investigate implementation and barriers 4. Determine if the effects~     of either strategy vary by patients' literacy skills. 5. Explore patient characteristics~     associated with CRC screening knowledge, beliefs, self-efficacy, and compliance over time~     between study arms.~   "
92297|NCT02359058|"~     The main purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and~     antitumor response of ramucirumab in combination with platinum/fluoropyrimidine regimens in~     Japanese participants with advanced gastric/gastrooesophageal junction cancer who have not~     received chemotherapy.~   "
92181|NCT02360566|"~     Prior research has shown that people with psychotic illnesses, like schizophrenia, who make~     sense of and meaningfully integrate their psychotic experiences into their life story are~     more likely to recover from their illness. This process of developing a coherent narrative~     seems especially relevant for young people who are experiencing their first episode of~     psychosis. There is a need for interventions that can help facilitate the formation of~     recovery-oriented narratives, particularly in the early stage of illness. Participatory video~     is a group process that involves the facilitated creation of short documentary-style videos~     in which individuals are supported to reflect on and tell their personal stories. Although it~     has been used to foster self-identity, self-empowerment and give voice to a variety of~     marginalized and stigmatized populations, its use and evaluation as a clinical intervention~     has been limited.~      The purpose of this study is to determine whether the novel use of participatory video~     facilitate narrative development and promote recovery for individuals with early psychosis is~     an effective, feasible, and acceptable means of treating youth in the early stages of~     psychotic illnesses. Although the current study is hypothesis generating in nature, the~     investigators are expecting that participating in the Participatory Video intervention will~     result in improvements in narrative development, symptoms, self-perceived recovery,~     self-esteem, self-stigma, social functioning and hope. Additionally, the investigators expect~     that Participatory Video intervention will prove to be acceptable to participants and a~     feasible intervention for early psychotic disorders.~   "
92182|NCT02360553|"~     Adolescents nowadays is having most of their times other than school hours spending on screen~     by playing games, watching the movies and surfing the internet. Thus, it was suggested that~     Internet-based interventions have the potential for establishing healthy dietary style and~     physical activity that may persist in adulthood and reduce the risk of chronic disease.~     Preventing adolescent obesity requires an attitude of willingness by adolescents to implement~     healthy behaviors. By providing the health related activities in website, it would help the~     adolescents to spend time on screen by having something which can benefit them and improve~     their knowledge and attitudes.~   "
92183|NCT02360540|"~     PERC rule was created to rule out pulmonary embolism (PE) without further exams, with~     residual PE risk <2%. Its safety is currently confirmed in low PE prevalence populations as~     north-American. In European high PE prevalence population, it has been showed that PERC rule~     used alone or associated with low clinical probability assessed by revised Geneva score (RGS)~     was not safe. In retrospective study, we suggest that the combination of PERC rule with~     implicit clinical probability (gestalt) could allow the use of the PERC rule.~      PERCEPIC, an observational prospective multicenter study performed in France and Belgium,~     will test this hypothesis. Therefore, 3000 patients will be included in 12 centers. Primary~     outcome will be the rate of thromboembolic events or death related or possibly related to PE~     in patients with low implicit clinical probability and negative PERC rule (8 criteria~     absents). Upper limit of confidence interval of this rate must be equal or lower than 3% to~     consider PERC rule as safe in this combination.~   "
92184|NCT02360527|"~     A clear association between type 2 diabetes (T2D) and Alzheimer's disease (AD) has been~     reported. This association is independent of vascular impairment, and therefore, it could be~     attributed to neurodegeneration triggered or accelerated by diabetes itself. At present there~     are no methods to identify T2D patients at risk for developing AD. The retina shares many~     features with the brain and, therefore, has been suggested as an easily accessible way of~     examining pathology in the brain. In fact, many patients with AD present retinal~     abnormalities. However, the diagnosis of diabetes, a condition frequently associated with~     retinal neurodegeneration, has not been considered. On this basis, the final aim of this~     proposal is to identify diabetic patients at risk for developing AD based on the assessment~     of retinal neurodegeneration by means of non-invasive tests. Specific aims: 1) To compare the~     prevalence of morphological and functional abnormalities related to retinal neurodegeneration~     among three groups of T2D patients: patients with AD, patients with Mild Cognitive Impairment~     (MCI) and patients without AD or MCI. 2) To assess whether the retinal neurodegenerative~     features are related to severity of AD. 3) To explore whether the combined retinal~     neurodegeneration in diabetic patients with AD has a different functional and/or~     morphological pattern in comparison with neurodegeneration secondary to diabetes alone.~     Methods: Case-control study. Retinal neurodegeneration will be assessed by mutifocal~     electroretinogram (mfERG) and spectral domain optical coherence tomography (SD-OCT). The~     potential confounders will be considered in data analyses. Feasibility: A unique~     multidisciplinary consortium has been created in order to warrant the feasibility of the~     project Expected impact: This innovative approach will fill a gap that currently exist in the~     health care system and will reduce the economic burden associated with T2D patients with AD.~     In addition, this project would be the backbone for future prospective studies.~   "
92185|NCT02360514|"~     This study was aimed evaluate long-term immunity response by neutralizing antibody test of~     adults in high risk population of HFRS .~   "
92186|NCT02360501|"~     The standard treatment strategy for locally advanced (stage IVA) and metastatic (stage IVB)~     nasopharyngeal carcinoma has not been defined yet. Generally induction chemotherapy is given~     to those patients in order to shrink the tumor volume and facilitate the following radiation~     therapy. Thus, in this study, the investigators use the combination of~     Docetaxel+Cisplatin+Xeloda (DCX) to treat locally advanced and metastatic nasopharyngeal~     carcinoma patients, in order to evaluate the efficacy and safety profiles.~   "
92187|NCT02360488|"~     The current study will test the effectiveness of a novel home-based telehealth system~     designed to improve motor recovery and patient education after stroke. A total of 124~     subjects (the number may be larger depending on the rate of subject dropout) with arm motor~     deficits 4-36 weeks after a stroke due to ischemia or to intracerebral hemorrhage will be~     randomized to receive 6 weeks of intensive arm motor therapy (a) in a traditional in-clinic~     setting or (b) via in-home telerehabilitation (rehabilitation services delivered to the~     subject's home via an internet-connected computer). The intensity, duration, and frequency of~     this therapy will be identical across the two groups, with subjects in both treatment arms~     receiving 36 sessions (18 supervised and 18 unsupervised), 80 minutes each (including a 10~     minute break), over 6 weeks. The primary endpoint is within-subject change in the arm motor~     Fugl-Meyer (FM) score from the Baseline Visit to 30 Day Follow-Up Visit. Arm motor status is~     the focus here because it is commonly affected by stroke, is of central importance to many~     human functions, and is strongly linked to disability and well being after stroke.~   "
92188|NCT02360475|"~     The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of~     different formulations of a single intramuscular dose of GSK Biologicals' investigational RSV~     vaccine, in healthy, non-pregnant women aged 18 to 45 years.~   "
92189|NCT02360462|"~     This is a clinical trial that intend to determine if transcranial direct current stimulation~     (tDCS) is effective in the treatment of postoperative pain and in the anxiety level in the~     preoperative period of hallux valgus surgical treatment~   "
92193|NCT02360410|"~     The proposed study is a randomized controlled trial that compares the effectiveness of an~     electronic personalized health screening app incorporating motivational feedback (i.e.,~     Check Yourself) to usual care. The purpose of this study is to determine whether Check~     Yourself is more effective than usual care in reducing health risk behaviors and improving~     quality of care among adolescents receiving primary health care services.~   "
92194|NCT02360397|"~     The purpose of this study is to determine whether ranolazine has beneficial effects on~     cardiac ischemia through reduction of premature ventricular contraction burden.~   "
92195|NCT02360384|"~     Irritable bowel syndrome is common. Currently, it is a diagnosis of exclusion. There is~     increasing evidence of the importance of the microbiota in the pathophysiology of this~     disorder. However, it has been challenging to measure the activity of the microbiota in~     vivo as much of the GI tract is inaccessible. Fermentation by the microbiota occurs in the~     colon, a by product of which are short chain fatty acids. Measuring pH in the colon could~     potentially act as a surrogate marker of fermentation. The investigators are undertaking a~     randomised controlled trial in patients with IBS measuring the pH in the digestive tract~     using a wireless motility capsule at baseline and in response to dietary changes in patients~     with diarrhoea predominant IBS and in response to linaclotide in those with constipation~     predominant IBS to ascertain the effect of these interventions on the microbiota and clinical~     outcomes.~   "
92196|NCT02360371|"~     This study will evaluate the magnitude of individual differences that exist in human response~     to a blinded study medication.~   "
92197|NCT02360358|"~     A prospective, multicenter, randomised controlled phase II study in which patients with~     therapy resistant (arterio-) venous leg/foot ulcers are treated with Tiscover® (test group)~     or with AS210 (control group) to determine the safety and relative efficacy of both products.~   "
92198|NCT02360345|"~     This is an open label, single-centre dose escalation phase 1 clinical trial of ONX-0801.~      The study will evaluate two schedules of ONX-0801 concurrently: once weekly and alternate~     week dosing, of repeated 28-day treatment cycles.~      The study will consist of two stages: the dose escalation phase, in which the recommended~     phase II dose will be determined; and the expansion phase, in which up to 30 patients will be~     treated at the recommended phase II dose and schedule to further support the design of~     subsequent trials of ONX-0801.~   "
92199|NCT02360332|"~     The aim of the research project is to conduct evidence-based research on a nationally known~     vocational rehabilitation (VR) service model (Project Search) for individuals with Autism~     Spectrum Disorders (ASD). This information may be useful to high schools and vocational~     rehabilitation agencies that endeavor to use evidence based practices to serve individuals~     with ASD.~   "
92200|NCT02360319|"~     The goal of this project is to show that the best possible option for preventing relapses in~     patients suffering from first episode (<1 year of anti-psychotic medication) or early phase~     (< 5 years of lifetime exposure to anti-psychotic medication) schizophrenia is by enhancing~     medication adherence. The study is designed to answer the question of whether the use of~     long-acting injectable (LAI) antipsychotics early in the course of treatment can break the~     cycle of frequent relapse that affects so many patients with early phase schizophrenia. The~     participating research sites (not individual patients) will be randomly assigned to either~     medication prescribed by their treating physician (with no restrictions) or to a regimen that~     involves a monthly long acting injectable antipsychotic. The sites will be assigned on a one~     to one basis to either of the arms taking into account types of patient population and~     geographical area. Patients enrolled in the study will participate in regular assessments~     either over the phone or in person and be followed for a period of 2 years. The primary~     outcome measure is time to first hospitalization.~   "
92201|NCT02360306|"~     Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is widely used~     in the diagnosis of mediastinal and hilar adenopathy as well as in staging in lung cancer~     patients. Many studies have confirmed the utility of EBUS-TBNA with high sensitivity,~     specificity, and accuracy for the diagnosis of mediastinal and hilar adenopathy. 1-3 Less~     well reported has been the use of the EBUS bronchoscope to perform other procedures such as~     transbronchial biopsy (TBBx), endobronchial biopsy (EBBx), bronchoalveolar lavage (BAL) and~     airway brushings. While not well reported in the medical literature, anecdotal evidence~     supports these practices. The investigators propose a methodological evaluation of the full~     spectrum of procedures that have been performed and that are possible using an EBUS~     bronchoscope.~   "
92202|NCT02360293|"~     This project is Project three of a four project Prevention Coaching Lab CREATE grant entitled~     Transforming Prevention into Action aimed at effectively engaging patients and their~     families to improve their health and medical care.~      This project will test the feasibility and effectiveness of the prevention focused, internet~     mediated healthy lifestyle Stay Strong program tailored to the needs, preferences and~     demographics of OEF/OIF Veterans.~   "
92203|NCT02360280|"~     About one-third of depressed patients will not get better after multiple antidepressant~     treatments. This situation put a high burden on patients with depression due to worsening~     quality of life and increasing health care costs. Difficult-to-treat depression might be even~     worse among Veterans given that the frequency of depressive symptoms is 2 to 5 times higher~     than among the general US population. A breakthrough discovery happened in recent years when~     investigators found that one infusion from an old anesthetic named ketamine showed high~     efficacy and rapid antidepressant effect (sometimes within hours) but lasted only up to a~     week. The investigators propose to study if multiple infusions of ketamine can provide~     greater and longer antidepressant effects than one infusion. If that is the case, multiple~     infusions could be an alternative to relieve depressive symptoms that do not response to~     multiple antidepressant drugs.~   "
92204|NCT02360267|"~     The goal of the Pediatric Bipolar Registry (PBR) is to provide a comprehensive assessment~     regarding the diagnosis and treatment of pediatric bipolar disorder to children and~     adolescents with any current mood state and/or children/adolescents who are offspring of a~     parent with bipolar disorder (BD) type I or II and their families.~   "
92237|NCT02359838|"~     This research study is evaluating if co-management by a geriatrician embedded in the oncology~     clinic can improve outcomes for frail older adults with blood cancers. A rigorous pre-entry~     frailty assessment by a trained research assistant will be followed by randomization to~     geriatrician co-management versus usual care for patients found to be frail or pre-frail.~   "
92205|NCT02360254|"~     Rationale. Degludec is a longer-acting insulin analog compared to glargine and detemir. In a~     fraction of type 1 diabetic patients, insulin glargine and insulin detemir may not achieve~     24h coverage, reflected by raising pre-dinner glucose levels when they are administered at~     bedtime. As up-titration of bedtime long acting insulin increases risk of nocturnal~     hypoglycaemia, this clinical problem can be addressed by an additional injection of in the~     morning. These type 1 diabetic patients may benefit from shifting from twice daily insulin~     glargine/detemir to once daily insulin degludec, which shows an extended activity over 24h,~     up to 48h.~      Objective. To evaluate the effects of shifting from twice daily insulin glargine or detemir~     to once daily insulin degludec on HbA1c and glucose profiles in type 1 diabetic patients~     during a period of 3 months.~      Study design. Observational analytic prospective study. Protocol. Type 1 diabetic patients on~     twice daily insulin glargine or detemir (because of pre-dinner hyperglycemia due to supposed~     glargine/detemir coverage <24h) will be identified and enrolled. During a run-in period of 1~     week, the investigators will collect data on HbA1c values as IFCC/DCCT-aligned and on glucose~     profiles using glucose meters. Patients will undergo a 7-14 day continuous glucose monitoring~     before and eventually during (additional 7-14 days) the shift from twice to once daily basal~     insulin. Patients will be re-assessed 12 weeks after initiation of insulin degludec with~     determination of HbA1c and 7-14 day continuous glucose monitoring.~   "
92206|NCT02360241|"~     This study aim is to evaluate the needle positioning precision, compared to the real path~     planned by the physician on healthy voluntaries, by positioning a fictional needle, without~     inserting it.~      Additionally, this study will evaluate:~        -  the robot precision,~        -  the robot detection robustness,~        -  the software and device ergonomics,~        -  the device security.~   "
92207|NCT02360228|"~     Investigating the effects of non-invasive transcranial current stimulation as a treatment for~     auditory hallucinations in patients with schizophrenia.~   "
92208|NCT02360215|"~     This randomized phase III trial compares memantine hydrochloride and whole-brain radiotherapy~     with or without hippocampal avoidance in reducing neurocognitive decline in patients with~     cancer that has spread from the primary site (place where it started) to the brain. Whole~     brain radiotherapy (WBRT) is the most common treatment for brain metastasis. Unfortunately,~     the majority of patients with brain metastases experience cognitive (such as learning and~     memory) deterioration after WBRT. Memantine hydrochloride may enhance cognitive function by~     binding to and inhibiting channels of receptors located in the central nervous system.~     Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Using~     radiation techniques, such as intensity modulated radiotherapy to avoid the hippocampal~     region during WBRT, may reduce the radiation dose to the hippocampus and help limit the~     radiation-induced cognitive decline. It is not yet known whether giving memantine~     hydrochloride and WBRT with or without hippocampal avoidance works better in reducing~     neurocognitive decline in patients with brain metastases.~   "
92209|NCT02360202|"~     Clinical observation frequently shows a paradoxical effect of topical corticosteroids in~     charge of a sudden melting of edema in the first days of treatment, which could be due to~     mobilization of extracellular. No study has shown the value of this measure in patients~     treated with topical steroids. This uncertainty, coupled with the observation of the~     paradoxical effects of topical steroids on edema are some patients that despite the systemic~     absorption of clobetasol propionate, a salt-free diet is not currently recommended practice.~   "
92210|NCT02360189|"~     Aim: To identify psychological and socioeconomic predictors of cardiac-rehabilitation (CR)~     attendance and uncover mechanisms of CR non-attendance.~      Design: Quantitative, observational, prospective study. Hypothesis a: Educational-level,~     comorbidity, anxiety, depression, self-efficacy, cohabitation and distance from residence are~     predictors of CR attendance.~      Hypothesis b: The expected social gradient in CR attendance is explained partly by~     differential exposure of comorbidity, anxiety, depression, self-efficacy, cohabitation and~     distance to the rehabilitation clinic.~   "
92211|NCT02360176|"~     Demonstrate non-inferiority of the single port for sleeve gastrectomy compared to the~     reference method in terms of complications using a score of morbidity and mortality at 6 and~     24 months: Rate of fistula, intra and extra abdominal abcess, hemorrhage, gastric stenosis,~     splenic lesions, hernia, residual gastric pouch and mortality~   "
92212|NCT02360163|"~     The purpose of this study is to reduce, by using the ultrasound guided technique, the minor~     surgical procedures that might be required to deliver fluids into the blood of critically ill~     patients simply because the patients' veins cannot be located through the manual technique.~   "
92213|NCT02360150|"~     The purpose of this study is therefore to show that associated with cardiac angiography~     echocardiography, in myocardial seen late, would provide the information necessary for the~     decision revascularization, in a timely manner.~      This would allow the patient to avoid duplication of tests including risk related to coronary~     angiography (bleeding complications, stroke ...) and those related to the implantation of~     coronary stent (stent) without expected earnings in case of non-viability . This would also~     reduce the length of hospital stay and costs due to numerous reviews.~   "
92214|NCT02360137|"~     Atherosclerosis is the most common cause of stroke. The aims of the project are to compare~     the visual and digital analysis of sonographic images of atherosclerotic plaque in carotids~     in vivo, in vitro and with a histological composition of the plaque obtained from patients~     indicated to carotid endarterectomy, to compare the characteristics of symptomatic and~     asymptomatic atherosclerotic plaques and, subsequently to verify a hypothesis that ultrasound~     can identify the sonographic plaque characteristics associated with an increased risk of~     plaque progression and of ischemic stroke (unstable plaque) in patients with carotid~     atherosclerosis. Identifying of the sonographic characteristics of unstable plaque will allow~     to improve indication criteria for carotid endarterectomy or stenting and also potential~     changing of a drug therapy in patients with unstable plaque in the future. Cost efficiency~     and availability of duplex ultrasound equipment may enable to improve diagnosis of unstable~     plaque using this new plaque characteristics evaluation in the majority of patients with~     carotid plaques.~   "
92270|NCT02359409|"~     This study aims to look if use of goggle balloon can help to complete colonoscopy in patients~     with very redundant colons.~   "
92271|NCT02359396|"~     This is a randomized open-label, three-arm, phase 1 clinical study. The investigators aim to~     investigate a Chinese Proprietary Medicine, MZRW on its tolerability, system exposure and~     pharmacokinetics profile.~   "
92215|NCT02360124|"~     This study is a randomized clinical trial lasting for 30 months. A total of 300 subjects will~     be recruited from social centres for elders located in different districts in Hong Kong.~     Baseline clinical examination will be conducted by a single calibrated examiner in the social~     centres using an intra-oral LED light, mouth mirrors and probes. Subjects will be randomly~     allocated into the three study groups and receive interventions accordingly. Follow-up~     examinations at 6-month intervals will be carried out to assess the clinical outcomes, i.e.~     whether new root caries has developed and whether the active root caries found at baseline~     have become arrested (remineralized and hardened) or not. Photographs of the arrested lesions~     will be taken to assess their colour. Results of this study will provide the much needed~     evidence to guide the dental professionals in Hong Kong and worldwide in deciding on the most~     appropriate intervention for the prevention and treatment of this common dental disease of~     the older adults.~   "
92216|NCT02360111|"~     This is a pilot study which will be done in a small number of patients. The purpose of this~     study is to test the safety and benefit of giving a type of chemotherapy - cyclophosphamide -~     after the transplant to prevent graft versus host disease (GVHD) in patients with abnormal~     kidney function. GVHD is one of the most common complications of a stem cell transplant .~   "
92217|NCT02360098|"~     Smooth emergence (wake up) from anesthesia is an important consideration in patients~     undergoing neurosurgical procedures as blood pressure changes associated with violent~     emergence can cause intracranial hemorrhage and brain swelling. At the same time, emergence~     should also be quick so that patients' neurological function can be assessed at a timely~     manner. Pattern of emergence from anesthesia is poorly investigated and understood. Epilepsy~     surgery involves resecting epileptogenic tissues including limbic structures which may be~     functionally normal. Hence the emergence process can be complicated in patients having~     diseased limbic structures or those having therapeutic removal of limbic structures as in~     epilepsy surgery. Limbic structures are responsible for memory, language and executive~     function and hence loss of some of these higher functions is to be expected in the~     postoperative period. Preoperative neuropsychological assessments are often used to predict~     their risk for postoperative loss of higher functions and behavior changes. In our experience~     the investigators have seen that there is a spectrum of emergence characteristics in patients~     undergoing temporal lobectomy that can vary from dangerously agitated patient to much~     sedated, unarousable patient. Delirium and agitation can be dangerous and have serious~     consequences for the patient such as injury, increased pain, hemorrhage, self-extubation and~     removal of catheters requiring physical or chemical restraint. On the other hand the~     unarousable patient may pose dangerous airway complications and limit neurological assessment~     in the immediate postoperative period. Hence it is essential to have a clue about post~     anesthesia emergence behavior in patients having epilepsy surgeries. The aim of this study is~     to look at the pattern of emergence from anesthesia after epilepsy surgery and to determine~     if preoperative neuropsychological assessment help predict the pattern of emergence in~     patients undergoing anterior temporal lobectomy and amygdalohippocampectomy.~   "
92218|NCT02360085|"~     Cervical myelopathy is commonly associated with degenerative spinal disease. Dysfunction of~     the autonomic nervous system is also evident in many cases of cervical myelopathy. Autonomic~     dysfunction may result in haemodynamic instability and hypotension under anaesthesia. It is~     important to maintain adequate mean arterial pressure in order to perfuse the spinal cord and~     prevent cord ischemia. Heart rate variability, the physiological variations of the~     differences between heart beats, has been used to diagnose autonomic dysfunction. In patients~     with cervical myelopathy it may enable the anaesthetist to predict hypotension thereby~     allowing for early treatment and prevention of spinal cord ischemia.~   "
92219|NCT02360072|"~     This is a prospective observational study , to clarity the characteristics of airway~     inflammation, airway reactivity and airway resistance in rhinitic children with or without~     asthma and to explore the possible predictors in the progression of allergic rhinitis to~     asthma.~   "
92220|NCT02360059|"~     The goal of this clinical research study is to learn if metformin can help to control nerve~     damage (loss of motor or sensory function) that may be caused by treatment with paclitaxel in~     patients with breast cancer.~      In this study, metformin will be compared to a placebo. A placebo is not a drug. It looks~     like the study drug, but it is not designed to treat any disease or illness. It is designed~     to be compared with a study drug to learn if the study drug has any real effect.~   "
92221|NCT02360046|"~     This study aims at assessing the effect of today's standard of hydrocortisone dosage versus~     previous hydrocortisone dosage on flexibility and partitioning of ectopic lipid depots (IMCL~     and IHCL) after a standardised fat load followed by a short-term aerobic exercise in patients~     with corticotropic pituitary insufficiency.~   "
92222|NCT02360033|"~     Goals of the study:~      Systemic Therapy was approved in 2008 by the Scientific Advisory Board on Psychotherapy~     (Wissenschaftlicher Beirat Psychotherapie: WBP) for a variety of disorders which, at the~     time, did not include anxiety disorders. According to the 2007 joint methods paper of the WBP~     and the Mutual Federal Committee (Gemeinsamen Bundesausschuss: G-Ba), there must be three~     randomized-controlled trials (RCT) for anxiety disorders. These studies are available now but~     lack explicit details about the clinical significance of the reductions they show in social~     anxiety symptoms. This project is funded by the German Association for Systemic Therapy,~     Counseling and Family Therapy (Deutsche Gesellschaft für Systemische Therapie, Beratung und~     Familientherapie: DGSF).~      Study design:~      The study is planned as a mono-centric, balanced pilot RCT. It investigates the feasibility~     of an RCT comparing Systemic Therapy and Cognitive Behavioral Therapy for Social Anxiety~     Disorders (SAD) in 32 patients.~   "
92223|NCT02360020|"~     Stent delivery failure occurs in 4% of all percutaneous coronary interventions (PCI) and >90%~     of these failures are due to vessel tortuosity and/or calcification. The XLIMUS eluting~     coronary stent (CARDIONOVUM GmbH, Bonn, Germany) is a new type of endovascular prostheses~     characterised by better mechanical properties than traditional DES. This is a prospective,~     non-randomized, single-center pilot study, aiming to evaluate the performance of the XLIMUS~     DES in severely complex coronary lesions in real-world clinical practice.~   "
92224|NCT02360007|"~     Despite the undisputed effectiveness of agonist maintenance for treating opioid dependence,~     current capacity is inadequate to meet need in the U.S. and internationally. Indeed, an~     alarming number of clinics have extensive waitlists for treatment slots. Patients can remain~     on these waitlists for years, placing them at elevated risk for illicit drug use, criminal~     activity, infectious disease, overdose and mortality during this period. These delays in~     treatment access represent a significant barrier to the widespread delivery of effective~     opioid treatment, and there is a critical need to develop creative new approaches for~     mitigating these delays. Our overarching goal in this application is to develop a novel~     Interim Buprenorphine Treatment (IBT) that can bridge delays in treatment access. Our~     integrative treatment package includes five key components, each strategically chosen to~     maximize patient access to pharmacotherapy for opioid dependence while minimizing~     nonadherence, abuse and diversion: Buprenorphine, Computerized adherence monitoring, mHealth~     clinical support delivered via Interactive Voice Response, Automated random call-backs for~     urinalysis and adherence monitoring, and HIV+Hepatitis Education delivered via iPad. The~     Primary Aim of this Stage I Behavioral and Integrative Treatment Development application is~     to evaluate the feasibility and initial efficacy of IBT in a 12-week randomized trial in~     which 70 opioid-dependent adults wait-listed for agonist maintenance are randomized to~     receive IBT (n=35) or continue in a Waitlist Control condition (WLC; n=35). WLC participants~     who have not entered treatment by Week 12 will be offered the opportunity to cross over to~     IBT at that time, contributing additional within-subject data with which to evaluate the~     efficacy of the IBT intervention. The proposed research is innovative in several important~     ways: By facilitating the eradication of waitlists for opioid treatment, it represents a~     significant departure from the status quo and stands to produce a fundamental shift in how~     treatment of opioid dependence is conceptualized and delivered. The IBT components are highly~     novel, both individually and as an integrative interim treatment package for opioid~     dependence. This study will be the first to investigate the utility of IBT in the patients~     and settings that stand to benefit most from it. The investigators also propose a~     multi-pronged dissemination approach that will ensure that our work is readily transported to~     clinical practice and will have a direct impact on real-world treatment of opioid dependence.~     Taken together, the proposed project will produce a highly innovative technology-assisted~     pharmacotherapy protocol that can be widely disseminated to increase access to life-saving~     opioid treatment. The overarching and specific aims of this proposal are directly relevant to~     NIDA's mission of improving the accessibility, implementation and effectiveness of drug abuse~     treatment.~   "
92235|NCT02359864|"~     This study is designed to assess the safety and toxicity/adverse events associated with the~     use of low dose fractionated whole brain irradiation in those patients who have been~     diagnosed with probable Alzheimer's disease according to the National Institute of~     Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related~     Disorders Association (NINCDS-ADRDA) criteria. As a secondary goal it will establish whether~     or not the intervention with low dose whole brain irradiation might change the recognized~     progression of Alzheimer's Disease. The investigators will also collect information from the~     AMYVID ® (florbetaben F 18 Injection) positron emission tomography (PET) Scans to determine~     if there is any correlation between neurocognitive/quality of life scores and changes in~     amyloid plaque size, number and location.~   "
92225|NCT02359994|"~     This is a prospective, multicenter, multidisciplinary, controlled clinical investigation~     evaluating the safety and efficacy of PerClot in achieving intraoperative hemostasis compared~     to a similar marketed hemostatic device.~      Three hundred and twenty four subjects across a maximum of 25 investigational sites~     undergoing open elective cardiac, general, or urological surgical procedures who meet the~     eligibility criteria will be intraoperatively randomized to receive no more than the entire~     contents of up to two 5 gram bellows of either the investigational device or a control~     hemostatic agent on a bleeding site, whose anatomic site is smaller than or equal to 25cm²~     and whose anatomic application site is smaller than or equal to 47cm², when bleeding is~     within the pre-defined bleeding severity range after any applicable conventional means for~     hemostasis are attempted as specified in the intraoperative procedures.~      Each investigational site is expected to enroll approximately 13-40 subjects. All~     investigational sites will be located in the U.S. Follow-up will occur at hospital discharge~     and 6 weeks post-device application. For oncologic subjects, an additional follow up will~     occur at 24 months post device application.~   "
92226|NCT02359981|"~     MyBehavior is a mobile application with a suggestion engine that learns a user's physical~     activity and dietary behavior, and provides finely-tuned personalized suggestions. To our~     knowledge, MyBehavior is the first smartphone app to provide personalized health suggestions~     automatically, going beyond commonly used one-size-fits-all prescriptive approaches, or~     tailored interventions from health-care professionals. MyBehavior uses an online multi-armed~     bandit model to automatically generate context-sensitive and personalized activity/food~     suggestions by learning the user's actual behavior. The app continually adapts its~     suggestions by exploiting the most frequent healthy behaviors, while sometimes exploring~     non-frequent behaviors, in order to maximize the user's chance of reaching a health goal~     (e.g. weight loss).~   "
92227|NCT02359968|"~     Resectable esophageal or junctional cancer requires medical treatment by radiotherapy and~     chemotherapy followed by surgery. Currently, one of the most commonly used chemotherapy~     treatment is the FOLFOX. It is a combination of three drugs administered intravenously:~     fluorouracil, oxaliplatin and folinic acid. This is the standard treatment.~      Another protocol of chemotherapy is widely used by certain European and American teams, due~     to promising results : a combination of two drugs administered intravenously: Paclitaxel and~     Carboplatin (CarboP-pacliT). At present, no clinical study has shown the superiority of one~     treatment over the other.~      The objective of this Phase II study is to clarify clinical practice by comparing these two~     chemotherapy treatments.~   "
92228|NCT02359955|"~     This study aims to evaluate masticatory efficiency of the zero-degree teeth complete denture~     in treatment of edentulous patients of severely resorbed ridge.Patients will be crossed over~     to be treated with zero-degree teeth complete denture and anatomic teeth complete denture.~     For each patient, the masticatory efficiency and electromyography with different denture will~     be recorded and analysis.~   "
92229|NCT02359942|"~     1. To compare the diagnostic accuracy of the 13C-Urea breath test between using the citric~          acid as test meal and controlled group by endoscopic biopsy methods(histology, CLOtest~          and H. pylori culture).~        2. To compare the delta value of 13CO2 results between before and after ingestion of citric~          acid as test meal.~   "
92230|NCT02359929|"~     Subjects in this study have had an allogeneic (blood or marrow cells from another person)~     blood or marrow transplant to treat leukemia, lymphoma or other cancer of the blood, and have~     now developed Graft Versus Host Disease (GVHD) that is not responding to standard treatment.~     GVHD is when the graft (transplanted bone marrow or blood) attacks the recipient's body. GVHD~     occurs early after transplant (acute) and/or sometimes months after transplant (chronic).~     Both forms can be life threatening; chronic GVHD can be a lifelong disabling condition.~      Mesenchymal stromal cells (MSCs) exist in tissues throughout the body. One place they are~     found is in the bone marrow and from here they can be obtained by needle aspiration, the same~     way bone marrow samples are obtained to test for leukemia. This study uses autologous MSCs~     obtained from the recipient with acute and/or chronic GVHD, which have a lower chance of~     being rejected. These MSCs may promote tolerance, helping the donor immune cells accept the~     recipient's body.~      This trial is being conducted as a step toward testing the long-term hypothesis that freshly~     cultured autologous MSC grown in platelet lysate-containing medium will modulate donor T-cell~     immune responses and reduce GVHD in allo-HSCT recipients. As a phase I dose escalation trial~     of autologous MSC in patients with acute and chronic GVHD, the main aim is to evaluate the~     safety of this therapy and its effects on GVHD biomarkers and T-cell phenotype~   "
92231|NCT02359916|"~     The pervasiveness of high-calorie, nutrient-poor snacks in the environment is believed to~     have contributed to the epidemic levels of obesity and cardiometabolic disease in the U.S.~     This project tests whether a novel snack vending machine system that uses brief time delays~     to reduce the immediacy of reward from unhealthy snacks will improve the healthfulness of~     snack choices. If successful, this project will identify a new environmental intervention~     that could contribute substantially to obesity and cardiometabolic disease prevention efforts~     in schools, worksites, and other settings.~   "
92232|NCT02359903|"~     ASART-1 clinical study is a phase 1 study which carried out to establish the pharmacokinetic~     equivalence and equal safety profile of BCD-055 (infliximab manufactured by JSC BIOCAD,~     Russia) and Remicade when used as multiple IV infusions for the treatment of ankylosing~     spondylitis.~   "
92233|NCT02359890|"~     This is a prospective safety assessment of the study device during radiofrequency (RF)~     ablation treatment of patients with drug refractory symptomatic atrial fibrillation~     (SMART-SF).~   "
92234|NCT02359877|"~     This is an international multicenter study of tolerability, pharmacokinetics and~     pharmacodynamics of drug product BCD-054 (CJSC BIOCAD, Russia), administrated intramuscular~     and subcutaneous, compared to Rebif® (Merck Serono S.p.A., Italy) and Avonex® (Biogen Idec~     Ltd, UK) in healthy volunteers. The study involves 2 stages - single ascending dose~     administration and multiple estimated therapeutic dose administration of BCD-054.~   "
92236|NCT02359851|"~     This phase II trial studies how well pembrolizumab works in treating patients with uveal~     melanoma that has spread to other places in the body and usually cannot be cured or~     controlled with treatment. Monoclonal antibodies, such as pembrolizumab, may block tumor~     growth in different ways by targeting certain cells.~   "
92238|NCT02359825|"~     Current strategies for peripheral nerve repair are severely limited. Even with current~     techniques, it can take months for regenerating axons to reach denervated target tissues when~     injuries are proximally located. This inability to rapidly restore the loss of function after~     axonal injury continues to produce poor clinical outcomes. The investigators propose testing~     the efficacy and safety of a combination therapy: polyethylene glycol (PEG) assisted axonal~     fusion technique to repair peripheral nerve injuries in humans.~   "
92239|NCT02359812|"~     Sensory and motor impairments following stroke can lead to substantial disability involving~     the arm and hand. The investigator hypothesized that excessive local and cross-coupled~     stiffness, diminished individuation and proprioceptive acuity will be present among multiple~     degree of freedom in the upper limb. The stiffness and spasticity will increase with time~     post-stroke. The objective of this study is to quantify the progression throughout the arm~     and hand during recovery from stroke. The investigator will measure the clinical assessment~     scores, and neuromechanical properties including range of motion, active and passive cross~     coupling, and spasticity by the IntelliArm robot.~   "
92240|NCT02359799|"~     The purpose of this study is to investigate the effectiveness of home-based and lab-based~     stretching and active movement rehabilitation on ankle impairments in children with cerebral~     palsy using a portable rehab robot. Children with spastic cerebral palsy are placed into two~     groups, participating in robot-guided passive and active movement training in a research lab~     setting (lab group) or in home setting (home group).~   "
92241|NCT02359786|"~     This is a retrospective data collection on treatment of various disorders. This registry will~     include a variety of different products, implants, technologies and procedures. The registry~     will also collect any adverse events/complications that occur during or following treatment~     of these conditions. The data may be utilized to develop strategic treatment pathways and/or~     benchmarking that will improve patient care. Ultimately, the goal of the registry is to~     enhance the understanding of healthcare and the treatment in these disease states.~   "
92242|NCT02359773|"~     The purpose of this pilot research study is to identify the characteristics of~     magnetocardiograms that correlate with a non ischemic chest pain status and a myocardial~     infarction patient status. The study uses a non SQUID magnetocardiogram device.~   "
92243|NCT02359760|"~     INTRODUCTION: Dentoalveolar surgeries such as piezocision, have been developed with the aim~     to accelerate the tooth movement and therefore reduce the length of orthodontic treatment.~     Although this surgical technique seems to present several advantages, such as decreased risk~     of decalcification or orthodontic relapse, its use as a routine practice is not yet~     recommended. The main purpose of this study is to determine the duration of orthodontic~     treatment by using the piezocision. The secondary objectives are to evaluate the effect of~     this surgical technique on bone density, root resorption, osteoclast activity, inflammatory~     events and pain assessment. MATERIAL AND METHODS: The investigators will conduct a~     prospective study. The experimental group will consist of 14 adults, subjects from 18 to 40~     years-old (10 women, 4 men). The control group will consist of 30 matched patients, who have~     been already treated in the orthodontic clinic of the University of Montreal. The~     reliabilities of Intra and Inter assesors will be measured for each doctor. After completion~     of the surgical guides from CBCT, the Piezocision will be performed the same day of the~     bracket indirect placement. The surgical procedure will be standardized and did it by the~     same surgeon. The appointments will be every 2 weeks for 4 months, then every month. The~     investigators will make an assessment of pain by using a numerical visual scale, during the~     first 7 days after surgery. Analysis of inflammatory markers (IL-1) and osteoclast activity~     (RANKL, OPG) will be evaluated from the gingival sulcus fluid collected at day 0, 1, 3, 5, 8,~     12, 16 and 24 weeks. At the end of the treatment, the overall quality evaluation of treatment~     using the American Board of Orthodontics' grading system would be realized by two blind~     external observers to limit bias.~   "
92244|NCT02359747|"~     try to find genomic DNA in culture medium after the embryos develop on Day 3 and Day 5 also~     in single step culture media. using direct PCR Polymerase Chain Reaction and also WGA Whole~     Genome Amplification before PCR and sequencing of the samples to find the point mutation~   "
92245|NCT02359734|"~     To identify the key issues around use of computerized patient infusion devices (called smart~     pumps).~      To develop strategies that will improve the prevention of intravenous errors that will be~     broadly applicable.~      The investigators will conduct a national study using the general methodology developed by~     Husch et al. to allow a rapid assessment of the frequency and types of medication errors at~     an institution.~      The key questions the investigators will address are:~        1. What are the frequency and types of intravenous medication errors?~        2. How much variability is there by frequency and type among settings?~        3. After review of the initial data, what strategies appear to have the greatest potential~          for reducing intravenous medication error frequency?~        4. How effective is an intervention including a bundle of these strategies at multiple~          sites?~   "
92246|NCT02359721|"~     The present study was done to evaluate the effect of clarithromycin as an adjunct to scaling~     and root planning at baseline, three months and six months intervals . Clinical,~     microbiological and immunological parameters were taken. Clinical parameters include gingival~     index , probing depth and clinical attachment level. In the present study, improved clinical~     and microbiological outcomes were attained using adjunctive clarithromycin, including GI, PD~     reduction, CAL gain and reductions in the frequency of detection of C-reactive protein, Pg,~     Aa. These results together with the recommended easy dosage and limited side effects make the~     use of this antibiotic in the treatment of periodontitis patients but only for a shorter~     period of time.~   "
92247|NCT02359708|"~     This study aims to investigate if recolonisation of the hand flora occur after surgical hand~     washing and is there a bacterial leakage at the glove cuff site in cardiac surgery? Also~     investigate if thera are differences in microbial flora and recolonisation between hospital~     and non-hospital persons.~   "
92248|NCT02359695|"~     The objective of this study is to assess whether a low dose of GH supplementation (0.5~     IU/day) increases clinical pregnancy rates in women with a history of POR who failed to~     become pregnant in two previous IVF cycles.~   "
92296|NCT02359071|"~     The primary aim of our study was to analyze the independent factors affecting handover~     duration in Emergency Department. The secondary aim was to identify the factors affecting~     Emergency Department handover rates.~   "
92249|NCT02359682|"~     This study will enrolled 90 healthy volunteers. The sublingual microcirculation will be~     examined by sidestreamdark-field videomicroscopy (MicroScan;Microvision Medical, Amsterdam,~     The Netherlands). Five video sequences (20 s) was obtained from different sublingual sites,~     and digitally stored the images with code numbers that did not reflect volunteers'~     information for later offline analysis by automated analysis software (AVA 3.0; Academic~     Medical Centre, University of Amsterdam, Amsterdam, The Netherlands).~   "
92250|NCT02359669|"~     The objective of the study is to explore the impact of a combined intervention including a~     growing up milk (GUM) fortified in micronutrients and cognitive stimulation on cognitive~     abilities, mother-child- interaction and behavior in children of 3 to 5 years from less~     enriched home environments.~   "
92251|NCT02359656|"~     The purpose of this study was to determine the clinical and radiographic long - term results~     in geriatric patients who had undergone surgical or non - operative treatment of odontoid non~     - unions, with particular regards to late bony fusion, cervical spine motion, neurological~     sequela, and patient's quality of life.~   "
92252|NCT02359643|"~     Kawasaki disease (KD) is an acute multi-system vasculitis syndrome of unknown etiology~     occurring mostly in infants and children younger than 5 years of age. In developed countries,~     it is the leading cause of acquired heart disease in children. However, KD remains a~     mysterious disease.~      Single high dose intravenous immunoglobulin (IVIG, 2gm/kg) and aspirin are standard treatment~     for KD. Aspirin have been prescribed in treatment of KD for decade even earlier than usage of~     IVIG. High dose aspirin mainly act as anti-inflammation, while low dose aspirin as~     anti-platelet. IVIG may play most of the role of anti-inflammation in acute stage of KD.~     Hsieh et al. reported that KD without high dose aspirin had the same treatment response after~     IVIG. Therefore it is still unclear about the necessarily of high dose aspirin in acute stage~     of KD.~      This study was conduct to investigate the role of high dose aspirin in acute stage of KD via~     a multi-center randomized control trail, and we plan to achieve the followings till year~     2017:~        1. Enroll 300 KD patients from multiple medical centers . Randomize group patients as group~          1: with high dose aspirin (more than 30/mg/kd/day) until fever subsided and shift to low~          dose aspirin (3-5mg/kg/day, N=150); and group 2: without high dose aspirin during acute~          febrile stage, only use low dose aspirin (N=150).~        2. Compare data including fever days, admission duration, laboratory data (CBC/DC, GOT/GPT,~          BUN/Cr, Alb, ESR, CRP, 2D echo), IVIG treatment response and CAL formation rate~          (followed at least 1 year).~   "
92253|NCT02359630|"~     Evaluation of the EzT in comparison with the endotracheal tube (ETT) for its use during~     general anesthesia.~   "
92254|NCT02359617|"~     The study seeks to evaluate a novel treatment approach for performing continuous real-time~     glucose sensing and insulin delivery at the same subcutaneous tissue site.~   "
92255|NCT02359604|"~     Proton Pump Inhibitors (PPI) are standard in the therapy of pediatric GERD. In the past it~     has been hypothesized, that either direct inhibition of bacterial ATPase or elevation of the~     pH may lead to changes in the intestinal microbiome. Small series published in adults suggest~     a predominance of streptococci, a possible reason for increased incidences of pneumonia under~     PPI therapy. Studies in children are yet scarce.~      This study will include 20 infants. GERD will be verified by 24h-intraluminal impedance~     monitoring. All patients will have undergone conservative measures prior to initiation of PPI~     therapy (due to persisting symptoms). Children will receive a commercial PPI for 8 weeks~     (esomeprazole 1mg/kg/day). Stool samples will be collected before initiation of PPI, under~     PPI (4 weeks after initiation) and 8 weeks after discontinuing PPI therapy. The intestinal~     microbiome will be determined by 16S rDNA-based microbial community profiling by~     high-throughput pyrosequencing.~      Data will be compared by dependent non parametric test (Wilcoxon). P-values <0.05 will be~     considered statistically significant.~   "
92256|NCT02359591|"~     【Background& Purpose】In order to early detect the problems a child might have during his/her~     development, an effective screening tool is of great needs. The [Taipei City Child~     Development Screening checklist] is often used to serve this process. This text version is~     mainly distributed to the parents to fill out during their child regular check-ups to the~     hospitals and clinics. The drawbacks of this checklist is that it lacks of active~     participation of the target population, and the text version limits its usage to people who~     are not familiar with Chinese characteristics, such as those new inhabitant. These lead to~     low screening rates therefore causing delayed early intervention. 【Purpose】The purpose of~     this study was to design and develop the multi-media graphic version of the [Taipei City~     Child Development Screening checklist] based on its original text version.【Method】The~     developed muti-media system will be checked for is validity. Thirty parents/legal guardians~     of children in each target age groups will be recruited randomly for the clinical reliability~     evaluation.~   "
92257|NCT02359578|"~     The lymphatic system is one of the keystones of fluid homeostasis in the interstitium. In~     analogy with the arterial systolic pressure, the lymphatic systolic pressure can give us~     information about the functioning of the cardiovascular system and fluid exchange. Actually,~     knowledge about this physiological parameter is incomplete because of the lack of technology.~     Former measurement techniques of the lymphatic systolic pressure in the living healthy man~     were invasive and too complex to be interpreted.~      The lymphatic occlusion pressure has to be clarified because lymphedema treatment, concerning~     the pressure to be applied on the edematous tissue is still based on controversial concepts.~      On one hand, techniques such as Manual Lymphatic Drainage, sustain the necessity to apply a~     very low pressure in order to avoid the squeezing of superficial lymph vessels. On the other~     hand sustainers of Intermittent Compression Therapy advocate the necessity to apply~     relatively high pressure to obtain a decongesting effect. These completely opposite opinions~     triggered us to study lymphatic pressure more thoroughly.~      Lymphofluoroscopy (emerging imaging technique in the field of lymphology) is now used since 3~     years by the promoters of this study to visualize the architecture of the superficial~     lymphatic network and the progression of the lymph inside the highlighted vessels. This~     technique will be used in the present (prospective and multicentric) study to observe the~     effect of a pressure applied on the limb on the displacement of the lymph, and then to~     determine the occlusion pressure of the lymphatic vessels.~   "
95748|NCT02313883|"~     A Pharmacokinetic Pilot followed by a Phase I/II, Blinded, Randomized, Controlled, Parallel~     Arm Trial to Evaluate the Safety, Tolerability and Efficacy of PerioSept® and Scaling and~     Root Planing in Subjects with Periodontitis~   "
92258|NCT02359565|"~     This phase I trial studies the side effects and best dose of pembrolizumab and to see how~     well it works in treating younger patients with high-grade gliomas (brain tumors that are~     generally expected to be fast growing and aggressive), diffuse intrinsic pontine gliomas~     (brain stem tumors), brain tumors with a high number of genetic mutations, ependymoma or~     medulloblastoma that have come back, progressed, or have not responded to previous treatment.~     Monoclonal antibodies, such as pembrolizumab, may block tumor growth in different ways by~     targeting certain cells.~   "
92259|NCT02359552|"~     This is a Phase II, randomized, double blind, placebo controlled, parallel group, proof of~     concept three-site study, to evaluate the effect of Rasagiline in the regional brain~     metabolism on 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG-PET).~   "
92260|NCT02359539|"~     The use of autogenous graft materials has been recorded to be a gold standard in regenerative~     therapy. This study directed toward evaluation of two autogenous regenerative materials,~     marginal periosteal pedicle graft (MPP) and platelet rich fibrin (PRF) as membrane barriers~     for treating intrabony defects. In spite of its reported significant clinical outcomes, the~     limited availability of the periosteum makes it necessary to evaluate other autogenous~     alternatives such as PRF that could offer predictable outcomes.~   "
92261|NCT02359526|"~     To provide treating physicians with experience with ILUVIEN as well as monitoring its safety~     (and effectiveness) in a real-life chronic diabetic macular edema (DME) patients judged~     insufficiently responsive to available therapies.~   "
92262|NCT02359513|"~     Bulimia nervosa (BN) is a serious mental illness characterized by massive food crises~     followed by anxiety and compensatory behaviours (vomiting more often). Recent data show an~     increasing prevalence and a serious prognosis, due to excess mortality by suicide but also~     somatic complications.~      Two types of treatments are validated : serotoninergic antidepressants (SSRI) and~     psychotherapy. Many clinical trials confirm the effectiveness of the SSRI. But many studies~     also emphasize the important proportion of non-responders to SSRI, few of them analyze the~     reasons for this non-answer.~      To better understand the mode of action of SSRI, we should analyse the serotonergic activity~     in the central nervous system in bulimia. Recently, specific brain 5HT1A serotonin receptor~     ligands ([18F] MPPF or [11 C] WAY-100635), were used in positron emission tomography (PET) to~     characterize the serotonergic abnormalities of bulimic patients. The ligand [18F] MPPF has~     the feature to be sensitive to the level of endogenous serotonin.~      A first pilot study using PET with [18F] MPPF realized between the University Hospital of~     Saint Etienne and Lyon CERMEP showed a diffuse increase of the binding potential of [18F]~     MPPF in bulimic patients, suggesting a decrease in serotonin activity.~      The brain regions affected were angular gyrus, medial frontal cortex, left insula, cingulate~     gyrus and orbitofrontal gyrus. These areas are involved in major bulimic symptoms (impulse,~     taste, instinct, anxiety and satiety). However, we noticed an interindividual heterogeneity~     of cortical binding of [18F] MPPF.~      In front of the heterogeneity in terms of efficacity of SSRI and brain serotoninergic~     activity, it seems necessary to continues investigations, to determine if there is a link~     between brain serotonin profile and responding to SSRI in bulimia nervosa.~   "
92263|NCT02359500|"~     This study plans to demonstrate the safety and efficacy of [68Ga]-DOTA-tyr3-Octreotide~     ([68Ga]-DOTATOC) as an accurate imaging technique for diagnosis, staging, and monitoring of~     response to treatment in patients with Somatostatin receptor expressing tumors who undergo~     imaging with a clinical indication. The investigators will conduct a study for 68Ga-DOTATOC~     as a diagnostic PET/CT imaging agent for the detection of NETs, mainly carcinoid tumors.~     68Ga-DOTATOC will be used in diagnostic assessment of patients with known or suspected NETs~     for whom there is an appropriate standard clinical indication for 68Ga-DOTATOC PET/CT either~     at staging or during follow up.~   "
92264|NCT02359487|"~     The overall purpose of this study is to evaluate an intervention that aims to reduce~     alcohol-related HIV sexual risk behaviors among HIV-negative men in Namibia. The objectives~     of the study are to determine the effectiveness of an individual counseling intervention in~     reducing alcohol-related HIV sexual risk behaviors among men, and in reducing harmful and~     hazardous alcohol use among men.~   "
92265|NCT02359474|"~     This trial compares trabectedin alone to trabectedin in combination with regional~     hyperthermia in patients with high-risk soft tissue sarcoma. The study is designed to~     demonstrate a significant benefit for sarcoma-therapy by adding regional hyperthermia.~   "
92266|NCT02359461|"~     The purpose of the study is to demonstrate an improvement of vascular function, and~     particularly dependent vasodilation flow and micro-vasculature, by STENDO for diabetic~     patients compared to a control period in crossover.~      Action by shear stress causing vasodilation away from the microcirculation, STENDO should~     have a beneficial effect on vascular function in type 2 diabetics. These effects could be~     both treble just after the completion of a session with the device, and chronic with a~     potentiating effect of different sessions.~      The investigators propose to study the different vascular function evaluation parameters we~     have, to highlight these acute and chronic changes. The investigators will also study the~     physical abilities to change topics and behavioral changes (spontaneous physical activity in~     particular) and impact on subject quality of life.~   "
92267|NCT02359448|"~     This is an an open label clinical trial of sustained-release Melatonin 2mg once daily for 12~     weeks in patients with Parkinsons's Disease reporting nocturia, defined as getting up~     regularly at night > twice to pass urine. The primary objective of this study is to evaluate~     the effects of exogenous melatonin on bother related to nocturia. Secondary objectives are to~     evaluate: 1) Mean night time urinary frequency 2)Volume of urine voided at night~     3)Incontinence and other lower urinary tract symptoms (LUTS) 3)Quality of sleep 4) Quality of~     life 5) Sleep disturbance of partners 6)Safety~   "
92268|NCT02359435|"~     Reverse hybrid therapy is a one-step two-phase treatment for Helicobacter pylori infection~     with less cost than standard triple therapy. Whether reverse hybrid therapy can replace~     standard triple therapy as the recommended first-line treatment is unknown. The investigators~     compared the efficacy of 12-day reverse hybrid therapy and 12-day standard triple therapy in~     first-line treatment.~   "
92269|NCT02359422|"~     The purpose of this study is to conduct a randomized controlled trial of a media literacy~     education program for middle school students with the goal of enhancing decision-making~     skills to prevent early and risky sexual behavior and teen pregnancy, and encourage healthy~     relationships.~   "
92272|NCT02359383|"~     Chest physiotherapy (CP) facilitates the absorption of fluid in the pleural cavity and~     reduces the formation of fibrous adhesions in patients with pleural infection, allowing a~     faster clinical, functional and radiological improve. The aim of the study is to determine if~     the CP associated with conventional medical treatment (CT) improves functional sequelae~     secondary to pleural infectious.~   "
92273|NCT02359370|"~     Justification and Objectives: The hemodynamic response to stimuli of the airways is a common~     phenomenon and its control is important to decrease systemic repercussions. The objective of~     this study is to compare the effects of intravenous administration of Magnesium Sulphate~     versus Lidocaine in the hemodynamics of this reflex after laryngoscopy and tracheal~     intubation. Methods: This double blind, randomized, single center, and prospective study~     evaluated 56 patients, ASA 1 or 2, aged between 18 and 65 years, scheduled for elective~     surgeries under general anesthesia with tracheal intubation. Patients were divided into two~     groups. Group M received 30mg/kg of Magnesium Sulphate, and group L 2 mg/kg of Lidocaine~     through continuous infusion, immediately before induction of anesthesia. The values for blood~     pressure (BP), heart rate (HR) and bispectral index (BIS) were measured in both groups at six~     distinct moments related to the administration of the drugs under study.~   "
92274|NCT02359357|"~     To determine the safety and tolerability of single and multiple escalating doses of FDL169 in~     healthy male subjects.~   "
92275|NCT02359344|"~     A randomized, double-blind, placebo controlled, two period crossover study to investigate the~     pharmacokinetics, tolerability and cognitive effects of 8 days dosing of CNV1014802 in~     healthy young versus elderly male and female subjects. Treatment periods will be separated by~     13 days. The primary outcome measures are pharmacokinetics (PK) and tolerability.~   "
92276|NCT02359331|"~     As increasing the antibiotics resistance, the effectiveness of traditional Helicobacter~     pylori (H. pylori) therapies has been declined coincidentally.~      In this study, the investigators evaluated the efficacy of H. pylori eradication between a 7~     days personalized therapy for H. pylori infection based on the results of antibiotics~     resistance by using H. pylori culture and minimal inhibitory concentration (MIC) and the 14~     days bismuth contained quadruple 2nd rescue regimens, and the investigators analyzed the~     prevalence of the antibiotic resistance after 1st eradication of H. pylori in the tailored~     therapy group.~   "
92277|NCT02359318|"~     Background: Orthodontic bracket debonding is known to cause side-effects such as enamel~     cracks or fractures. There is a lack of information on potential benefits or side-effects of~     removing brackets from infiltrated enamel, in terms of enamel damages, in vivo.~      Purpose: To assess enamel damages following debonding in demineralised teeth with or without~     prior infiltration (Icon, DMG, Hamburg, Germany), compared to those following bracket removal~     from sound enamel, in order to provide guidelines for the right time point of infiltration of~     post-orthodontic lesions (during or following orthodontic treatment).~      Design: Single-center, randomized, single blinded, split-mouth controlled clinical trial~     Subjects: 30 subjects with fixed multi-bracket (MB) appliances treated at the orthodontic~     clinic of Dr. Roberto Vogel, Temuco, Chile: It is planned to include 20 consecutive patients~     with extensive decalcifications, and 10 patients without decalcifications. Random allocation~     of demineralized dental arch quadrants to the different treatment groups (debond with or~     without prior infiltration, and sound teeth).~      Investigated tooth groups: Upper and lower canines, and upper and lower incisors.~      Methods: Bracket bonding procedure (Transbond XT 3M, Unitek) is identical for all patients~     and also for the re-attachement of brackets. Teeth allocated to the infiltration group will~     receive bracket removal, infiltration and rebonding of new brackets 4 weeks prior to final~     debonding. De-bonding procedures are identical for all patients.~      Silicone replicas are made directly following bracket removal (prior to adhesive removal).~     Replica analysis is performed using a confocal microscope (Zeiss LSM780) at the Department of~     Cell Biology, University of Concepción, Chile.~   "
92278|NCT02359305|"~     This is a retrospective chart review. The objective of the current study is to determine the~     analgesic efficacy and side effect profile of intravenous acetaminophen when administered to~     infants undergoing pyloromyotomy. In addition, recovery characteristics of infants who were~     administered intravenous acetaminophen will be compared to infants who did not receive~     intravenous acetaminophen to determine if there were any appreciable differences with regard~     to postoperative discomfort, PACU time, time to oral feeds and hospital discharge.~   "
92279|NCT02359292|"~     The study is performed to evaluate the total systemic exposure and lung bioavailability of~     CHF 5993 pMDI combination, in healthy volunteers subjects.~   "
92280|NCT02359279|"~     The proposed test is intended to enable dentists to differentiate between cavitated and~     non-cavitated tooth decay in the areas where teeth are in contact (interproximal surfaces).~     In these areas, dentists cannot visually inspect for caries, and currently bitewing X-rays~     (BWs) only correctly detect the presence of enamel decay 15-25% of the time. This low~     sensitivity can lead to late treatment resulting in unnecessarily large fillings, crowns,~     pain, root canals, and possible later loss of teeth.~   "
92281|NCT02359266|"~     This study evaluates the efficacy of vitamin D replacement therapy in reducing depressive~     symptoms in patients with chronic liver disease and vitamin D deficiency. Patients with~     normal vitamin D levels will be monitored as controls, and they will not receive any~     intervention.~   "
92282|NCT02359253|"~     Sensorimotor impairments following stroke often involve complex pathological changes across~     multiple joints and multiple degrees of freedom of the arm and hand, thereby rendering them~     difficult to diagnose and treat. The objective of this study is to evaluate multi-joint~     neuromechanical impairments in the arm and hand, then conduct impairment-specific treatment,~     and determine the effects of arm versus hand training and the effects of passive stretching~     before active movement training.~   "
92283|NCT02359240|"~     The current project was designed to examine dynamic changes in muscle wasting during sepsis.~     Researchers will focus the mitochondrial dysfunction of muscle cells and investigate the role~     of HO-1 in it. Researchers interested in identifying factors involved in the pathology of~     muscle wasting during sepsis.~   "
92284|NCT02359227|"~     Planned enrollment is approximately twelve subjects with stable chronic heart failure.~     Enrolled subjects will receive up to eight sequential days of continuous, stepwise, dose~     increasing, subcutaneous (SQ) infusions of open-label cenderitide via the Insulet Drug~     Delivery System. Planned infusion rates of cenderitide will be administered to subjects~     continuously during four, 48-hour infusion periods.~   "
92285|NCT02359214|"~     Supplementation studies with vitamin D have been performed where cardiometabolic risk markers~     have been assessed but these are few, and results are inconsistent. Hence, the purpose of~     this study is to determine:~        1. Whether administering supplemental Vitamin D3 at a dose of 5000IU/day (125µg) in~          overweight and obese adult participants for 8 weeks will significantly increase~          circulating concentrations of 25(OH)D or achieve optimal vitamin D status.~        2. Whether administering supplemental Vitamin D3 at a dose of 5000IU/day (125µg) in~          overweight and obese participants for 8 weeks will significantly improve the~          cardiometabolic parameters measured.~        3. To evaluate the relationship between these variables and 25(OH)D concentration. We~          hypothesise that there will be a significant increase in plasma 25(OH)D following 8~          weeks (56days) supplementation of oral vitamin D3 at a dose of 5000IU/day (125µg);~          Administering supplemental Vitamin D3 at a dose of 5000IU/day (125µg) in overweight and~          obese participants for 8 weeks will significantly improve the cardio metabolic~          parameters measured, and there will be a relationship between these variables and~          25(OH)D concentrations.~   "
92286|NCT02359201|"~     The purpose of this study is to evaluate the reduction of craving after administration of~     V0018 1.5 mg compared to placebo in healthy moderately dependent smokers.~   "
92287|NCT02359188|"~     Randomized, double-blind trial to investigate the influence of a single 4 hours episode of~     transcutaneous vagal nerve stimulation on the expression of microRNA, various cytokines,~     chemokines, neuropeptides, cerebral resting state and gastric motility in healthy volunteers.~   "
92288|NCT02359175|"~     Whereas it, in the case of conventional thoracotomy, has been demonstrated that thoracic~     epidural analgesia is more effective than systemic opioids in terms of pain relief and~     preservation of postoperative pulmonary function, the efficacy of epidural analgesia in~     video-assisted thoracic surgical (VATS) procedures, has not been sufficiently studied, but a~     beneficial effect might very well be present.~      On the other hand, the risks associated with placement of a thoracic epidural catheter are~     well known and if similar pain relief can be achieved without it with no or only~     insignificant alternative side effects, this would be preferable.~      The literature regarding the usefulness of epidural analgesia for reducing pain in~     Video-Assisted Thoracic Surgery is, at best, scarce with two small studies showing some~     effect and two showing no difference, none of the studies being blinded randomized controlled~     trials of adequate size.~      The SEAVATS Study will try to answer this question.~   "
92289|NCT02359162|"~     Purpose :To compare the efficacy and and safety of the P-Gemox chemotherapy regimen with~     those of the EPOCH regimen for stage IE to IIE ENKTL.~   "
92290|NCT02359149|"~     Anti-VEGF agents are given for a variety of previously untreatable eye diseases. The last~     years indications for their use and consequently the number of patients needing treatment,~     have been increasing. Most patients require multiple injections. This has resulted in many~     eye departments administering thousands of injections per year, also at St Olavs University~     Hospital Trondheim. To cope with this increase in workload, it would be helpful if injections~     would be given not only by the physicians but also by the nurses. This study's objective is~     to compare efficiency, patient satisfaction and cost per patient of injections given by~     nurses and physicians.~   "
92291|NCT02359136|"~     Background: The Local infiltration analgesic (LIA) technique has been widely used to reduce~     opioid requirements and improve the patient's mobilization after total hip arthroplasty~     (THA). However, the evidence for LIA in THA remains to be clarified.~      Purpose: To evaluate whether a single shot LIA in addition to a multimodal analgesic regimen~     reduces acute postoperative pain and opioid requirements after THA.~   "
92292|NCT02359123|"~     The main purpose in the treatment of patients with advanced cancer and cancer anorexia~     cachexia syndrome (CACS) is to prolong life and to improve quality of life (QoL) as far as~     possible. QoL in patients with CACS is directly related to loss of appetite and loss of~     weight. Cannabis pills are given in Israel to advanced cancer patients with various symptoms~     in order to improve their QoL. There is data on safety/toxicity of cannabis, and these pills~     are given under the regulations of the Israel Ministry of Health.~      The purpose of this study is to examine the influence of Cannabics capsules on improving loss~     of appetite and loss of weight.~   "
92293|NCT02359110|"~     The purpose of this study is to prospectively determine the influence of immediate~     pre-operative gabapentin administration on acute postoperative pain. The investigators~     hypothesize that immediate post-operative pain will be improved with pre-operative~     administration of gabapentin.~   "
92294|NCT02359097|"~     This clinical trial studies steady state blood volume maps using ferumoxytol~     non-stoichiometric magnetite magnetic resonance (MRI) in imaging patients with glioblastoma.~     MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used~     to create detailed pictures of areas inside the body. Contrast agents, such as ferumoxytol~     non-stoichiometric magnetite, may enhance these pictures and increase visibility of tumor~     cells and the blood vessels in and around the tumors.~   "
92295|NCT02359084|"~     Emerging evidence demonstrates that Autism Spectrum Disorder (ASD) can be reliably diagnosed~     by age two, and that early identification and intervention can improve outcomes. Low-income~     and minority children with ASD, however, are diagnosed later and experience greater delays in~     service provision than their white and more financially advantaged peers. Feasible,~     culturally appropriate interventions with broad scale-up potential are necessary to reduce~     this disparity. This project builds upon pilot studies of an adapted version of Patient~     Navigation, as means to reduce disparities in ASD diagnosis and service provision. Patient~     Navigation is a lay-delivered case management approach that focuses on overcoming logistical~     hurdles to care during a defined episode.~      This project has 2 components, both of which take place in urban, integrated care networks~     that provide healthcare to low-income children. This registration is for the clinical trial~     component of the study. The project is a multisite, randomized comparative effectiveness~     trial of a systemic, lay-delivered adaptation of Patient Navigation, referred to as Family~     Navigation (FN), which begins with a failed autism screen and ends 100 days after an ASD~     diagnosis is made. The basic structure of both intervention arms is a collaborative care~     system. The conventional care management arm (CCM) is consistent with the type of care~     provided within a traditional - but high quality - medical home. The FN arm provides more~     intensive, individually tailored, care coordination and theory-based family support.~   "
92298|NCT02359045|"~     This study is a randomized, open-label, cross-over study in healthy subjects performed at a~     single study center. The study is divided into two parts, Part 1 and Part 2. The purpose of~     the study is to compare the pharmacokinetics (PK) of three different prototype capsule~     formulations (omega-3-carboxylic acids test formulations) with Epanova® capsules 1000 mg~     under fasted conditions in Part 1 and under fed conditions in Part 2. The results will be~     used as basis for choice of formulation for further pharmaceutical development.~   "
92299|NCT02359032|"~     The purpose of this study is evaluate the safety and tolerability of single and multiple~     ascending oral doses of ASP6858. This study will also evaluate the pharmacokinetics (PK) of~     ASP6858 and its metabolites as well as the effect of food to the PK of ASP6858. The study~     will also evaluate the pharmacodynamics of ASP6858.~   "
92300|NCT02359019|"~     This phase II trial studies how well pembrolizumab works in treating patients with extensive~     stage small cell lung cancer after completion of combination chemotherapy. Pembrolizumab may~     be effective in controlling small cell lung cancer for a longer period of time in patients~     with responsive or stable disease after completion of combination chemotherapy.~   "
92301|NCT02359006|"~     Opioids are the most commonly utilized pharmacological treatment for moderate to severe pain.~     However, their clinical value is hindered by the development of opioid-induced hyperalgesia~     (OIH). OIH manifests as heightened pain sensitivity, and is an increasingly challenging~     drawback to the efficacy of opioid treatment. Although the mechanism of action modulating OIH~     is not completely understood, previous animal studies suggest that this phenomenon is a~     result of proinflammatory responses. Thus, administering an adjunct anti-inflammatory agent~     may attenuate OIH. Minocycline is one such agent; it is a tetracycline derivative antibiotic~     that inhibits microglia activation, nitric oxide (NO) production, and the release of~     pro-inflammatory cytokines and chemokines. In fact, recent evidence suggests that minocycline~     may attenuate the neuroinflammatory effects of opioids while enhancing their antinociceptive~     effects. Therefore, the investigators will determine if minocycline will mitigate OIH in~     methadone-maintained patients.~   "
92302|NCT02358993|"~     The investigators will determine the efficacy of an innovative short regimen of methenamine~     hippurate on prevention of post-operative UTI in patients requiring short-term~     catheterization after pelvic reconstructive surgery through a single-blind, randomized~     controlled trial. Primary outcome will be the rate of symptomatic UTI within 3 weeks of~     catheter removal. The investigators will study cost-effectiveness, antibiotic resistance~     profiles, and adverse drug effects. Findings may reduce antibiotic use and nosocomial UTIs.~   "
92303|NCT02358980|"~     Hypothesis: Free light chain (FLC) removal haemodialysis will increase the rate of renal~     recovery in patients with cast nephropathy, severe renal failure and de novo multiple~     myeloma.~      This study will evaluate patients with multiple myeloma and severe renal failure treated with~     KIDNEY Therapy (previously called SUPRA HFR) to remove free light chains.~   "
92304|NCT02358967|"~     Patients undergoing chronic hemodialysis are at increased risk for cardiovascular disease,~     attributed in part to increased oxidative stress, inflammation and dyslipidemia. Intervention~     with a naturally occurring dietary supplement may improve certain biomarkers of inflammation~     and oxidative stress and improve the lipid profile.~   "
92305|NCT02358954|"~     The goal is to establish the practical usefulness of vestibular stimulation for modulating~     pain perception and to describe the possible mechanisms that could underlie neural~     vestibular-somatosensory interactions.~   "
92306|NCT02358941|"~     Attention deficit/hyperactivity disorder (ADHD) is among the most common childhood-onset~     psychiatric disorders, with a negative and long-lasting impact on academic achievement,~     social integration and quality of life. In recent years, the efficacy of non-pharmacological~     treatments for ADHD, such as neurofeedback training (NF) and computerized cognitive training~     (CCT), has been at the centre of research. Although an increasing number of well-designed~     studies have shown that both methods may improve ADHD core symptoms according to parents'~     ratings, the underlying mechanisms are still a matter of debate. Teachers often report~     smaller improvements, if any. This has been explained by their lesser involvement in the~     training. It remains questionable, however, whether other factors may also account for this~     effect and whether methods other than placebo control may be applied in order to demonstrate~     the specificity and efficacy of NF and CCT.~      The main purpose of this project is to demonstrate and compare the efficacy of two different~     computer-based treatment methods for children and adolescents with ADHD, namely NF and CCT,~     and to examine the impact of different treatment settings, with half of the participants~     being trained in a clinical setting and the other half at school. The investigators want to~     show that is feasible to implement NF and CCT in a school setting and that both methods,~     conducted either at school or in a clinical setting, may lead to significant improvements of~     ADHD symptoms as well as to specific and differential effects. Besides the differential~     impact of the settings on informant ratings, the investigators will evaluate the effects of~     the training methods on neuropsychological and electrophysiological outcome. Classroom~     behavior of the children before and after the training will be evaluated by trained observers~     not informed on treatment assignments and settings.~   "
92307|NCT02358928|"~     Concurrent with the rising prevalence of childhood obesity, the co-morbid condition of~     non-alcoholic fatty liver disease (NAFLD) has become the leading cause of chronic liver~     disease among children. NAFLD is characterized by accrual of excess triglycerides (TG) in the~     liver that leads to inflammation, fibrosis, and cirrhosis. One-third of the pediatric~     population has NAFLD, a disease strongly associated with insulin-resistance and~     metabolic-syndrome (Met-S). NAFLD is predicted to become the leading cause of liver~     transplantation in adults by 2030.~      Current understanding of NAFLD indicates that presence of excess TG in liver is an absolute~     requirement for disease progression. First-line therapy for NAFLD is focused on decreasing~     adiposity and improving insulin sensitivity through diet and exercise. Recent adult data~     indicate that dietary carbohydrate-restriction is more effective at reducing hepatic~     TG-content than traditional calorie-restriction. Few studies have been conducted to establish~     resolution of hepatic steatosis by any intervention. Such studies in pediatrics are primarily~     limited by a need for liver biopsy. However, hepatic proton magnetic resonance spectroscopy~     (H-MRS) is a new innovative tool used to quantitatively measure hepatic TG content in a~     non-invasive manner.~      The primary aim is to compare the impact of dietary weight loss via carbohydrate-restriction~     and calorie-restriction on hepatic TG-content quantified by H-MRS in obese children with~     biopsy-proven NAFLD and Met-S.~      This IRB approved protocol is a randomized control study. The investigators will recruit~     subjects from the Center for Obesity and its Consequences in Health and the pediatric~     gastroenterology clinics between the ages of 11-17 years who meet criteria for NAFLD and~     Met-S. A H-MRS will be obtained in each subject prior to the start of dietary intervention.~     Fifty-four subjects will be randomized to either a carbohydrate-restricted or~     calorie-restricted diet for 6 months with no change in baseline activity. A repeat H-MRS will~     be compared to baseline to determine the whether dietary carbohydrate-restriction is superior~     to calorie-restriction for reducing hepatic TG content. The investigators believe that~     subjects on the carbohydrate-restricted diet will have marked decrease in hepatic TG content~     compared to those in the calorie-restricted diet given the same degree of reduction in body~     mass index.~   "
92308|NCT02358915|"~     The current study intends to test the effectiveness of a two-step training paradigm for a set~     of skeletal muscles, which are above and behind the external portion of the ear~     (Peri-auricular muscles).~   "
92309|NCT02358902|"~     This study consists of a randomized, double-blind, clinical trial with two months' duration~     of follow-up. The variable used was the VAS for pain, considering the values of any~     difference between the data before and after stimulation.~   "
92310|NCT02358889|"~     The purpose of this study is to evaluate the safety, biological activity and pharmacodynamic~     effect of repeated intravitreal doses of hI-con1 0.3 mg administered as monotherapy and in~     combination with ranibizumab 0.5 mg compared to ranibizumab 0.5 mg monotherapy in treating~     patients with choroidal neovascularization (CNV) secondary to age-related macular~     degeneration (AMD).~   "
92311|NCT02358876|"~     Study objectives are to improve motion sensor algorithms for measuring bradykinesia in the~     clinic and the home, evaluate test-retest reliability of motion sensor algorithms for~     measuring bradykinesia compared to clinician raters, determine if participant-perceived~     symptom severities correlate with motion sensor measures, determine if speed, amplitude, and~     rhythm fluctuate differentially throughout the day in individuals with implanted deep brain~     stimulation systems, receive feedback on the usability of Kinesia One, and evaluate Kinesia~     One compliance in the home.~   "
92312|NCT02358863|"~     The purpose of this study is to determine whether molecular profile-directed therapy~     (otherwise known as personalized treatment) can improve the effectiveness of standard~     chemotherapy combinations for patients with esophagogastric adenocarcinoma. A series of tests~     will be performed on a sample of tumor; based on the results of these tests, a patient will~     be assigned to a chemotherapy treatment.~   "
92313|NCT02358850|"~     This is a randomized prospective study to determine the optimal postoperative pain medication~     regimen for adults (18 years old and older) undergoing tonsillectomy with or without~     adenoidectomy for chronic tonsillitis and/or snoring and/or obstructive sleep apnea. All~     participants will undergo the same tonsillectomy surgical technique (with or without~     adenoidectomy) under general anesthesia and be randomized to one of three postoperative pain~     control regimens (all of which are commonly used pain medications for post-tonsillectomy~     pain):~        1. Norco (Hydrocodone and Acetaminophen)~        2. Percocet (Oxycodone and Acetaminophen)~        3. Dilaudid and Tylenol (Acetaminophen)~      Participants will be discharged home the day of surgery and will be sent home with~     questionnaires to assess their daily pain level, oral intake, amount of nausea/vomiting, and~     amount of pain medications taken for the 14 days following their surgery. Data will be~     collected and analyzed to determine if there is a difference in pain levels or oral intake or~     nausea/vomiting in the different pain regimen groups. Secondary endpoints will include weight~     change from preoperative weight to weight at 2-3 weeks after surgery in addition to~     postoperative complications including visits to the Emergency Department and~     post-tonsillectomy bleed rates.~      Participants will be seen 1-2 weeks following their surgery in the ENT (Ear, Nose and Throat)~     clinic per normal postoperative protocol and will not require any specific clinic visits~     related to this study.~   "
92314|NCT02358837|"~     With the proposed project we seek to advance the detection and diagnosis of breast cancer in~     an outpatient breast clinic. Novel sonographic approaches will be scrutinized. The first aim~     of this study will be to explore whether there is an advantage of ductosonography over~     conventional breast sonography in detecting and localizing breast lesions by comparing the~     diagnostic accuracy of ductosonography and conventional breast sonography in detecting~     suspicious and unclear sonographic lesions.In Addition, reliability and time requirement of~     ductosonographic examination will be investigated. The second specific aim is to investigate~     the potential of tissue elasticity as a diagnostic marker in solid breast lesions (US-BI-RADS~     3, 4 and 5) by elastosonography. The study design allows investigating the reproducibility of~     the method.~   "
92315|NCT02358824|"~     A randomized, open-label, single-dose, four-period, two-way, crossover study,~   "
92316|NCT02358811|"~     Sleep apnea is a common disease in the general population and more particularly in elderly~     subjects in whom prevalence can reach 30 % after 70 years old. In adults (<55 years old)~     cardiovascular consequences are well known and make sleep apnea treatment necessary. However~     elderly (>70 years old) apneic subjects are less symptomatic in terms of sleepiness, they~     usually present a lower index of respiratory events and cardiovascular consequences in this~     population are still discussed, driving some authors to consider sleep apnea in the elderly~     as a specific disease and making the need for a treatment questionable.~      In this study the investigators will focus on the comparison between adult and elderly apneic~     subjects in terms of cognitive and cardiovascular consequences. Adult apneic patients suffer~     from a decrease of cognitive performance as well as grey matter local atrophy, particularly~     in the hippocampus and in the frontal lobes. According to fewer studies, white matter can~     also be affected by a demyelinisation process. These structural modifications are sometimes~     associated with disorders of executive and memory functions. In the elderly, no clear~     association can be drawn between cognitive decline and sleep apnea. Moreover, to our~     knowledge, the cerebral state of elderly symptomatic apneic subjects has mostly not be~     investigated.~   "
92317|NCT02358798|"~     The widespread neonatal detection of cystic fibrosis in France since 2002 permits to treat~     children from birth. New treatments used for young children involve to assess efficacy~     criteria specific to this population. Standard respiratory function criteria for older~     children and adults is forced expiratory volume/second.~      This technique is not suited for preschool aged children (3 to 6 years old) because they are~     too old to be sedated and too young and immature to be able to make forced expiration~     technique that are correct, reproducible and prolonged during more than 1 second.~      For preschool aged children, in order to assess distal damage and her consequence, the~     evaluations are: airway resistance by debit interruption technic (Rint), plethysmographic~     measure of specific resistance (sRaw), functional residual capacity by Helium dilution~     technique (CRF He), arterial blood gas measurement, pulmonary clearance index.~      All these methods have a better success rate and can be used in alternative or with forced~     spirometry. However, each of them gives only a part of information on airway and lung damage~     of detected children. It is necessary to combine them for a better information on overall~     respiratory damage.~      In France, each respiratory function test laboratory uses one or any of these methods in~     addition to flow-volume curve, in function of his practices and his equipment.~      So, respiratory function test of preschool aged children is going to diversify more and more~     to the detriment of an homogeneity of practices between different centers.~      A referent population during a longitudinal multicenter monitoring on large cohorts that~     describe the evolution of pulmonary function, obtained by a standardized methodology is~     necessary to assess the efficacy of any new treatment. And, with the homogenization of care~     of children detected of cystic fibrosis in different centers, the description of natural~     evolution of pulmonary function by a standardized methodology will improve the discriminative~     power of measure of respiratory function to assess the presence of a worsening in~     preschool-aged children.~   "
92318|NCT02358785|"~     This study will provide clinical data in an observational setting. Individuals undergoing~     LSG, and who meet study entry criteria, may be enrolled. LSG procedures will be performed~     according to institutional standard-of-care (SOC) using the study stapler. All study subjects~     will be followed for approximately 4 weeks for safety and outcomes.~   "
92319|NCT02358772|"~     This is a comparison of clinical outcomes between a pre-hospital and an in-hospital~     thrombolysis patient registry.~   "
92320|NCT02358759|"~     In this newly developed protocol, and idea, is to manage those abnormally developed zygotes~     from different ART procedures.~      The investigators developed the plan and requirements needed to select the target extra~     nucleus or pronuclei to be extruded from fertilized egg in order to maintain developing~     healthy normal embryo.~   "
92321|NCT02358746|"~     Rationale: Nowadays ventricular tachycardia (VT) ablation in structural heart disease is~     performed primarily by early referral; while at the same time we still struggle with the~     limited longterm ablation success of endocardial VT ablation. An underestimated number of VTs~     from ischemic substrate have an epicardial exit. However, one cannot accurately predict who~     is in need of epicardial ablation. The investigators hypothesise endo/epicardial substrate~     homogenization in a first approach to be superior to endocardial substrate homogenization~     alone, in terms of recurrence on follow-up.~      Objective: To show superiority of a combined endo/epicardial approach compared to a stepwise~     approach in the ablation of ventricular tachycardia in a population with ischemic~     cardiomyopathy on VT recurrence.~      Study design: Multicenter prospective open randomized controlled trial. Study population: All~     patients above 18 years with an ischemic cardiomyopathy being referred for a ventricular~     tachycardia ablation.~      Intervention: One group undergoes endo/epicardial ablation and the other group has~     endocardial ablation only as a first approach.~      Main study parameters/endpoints: The main study endpoint is the difference in recurrences of~     ventricular tachycardia on follow-up - clinical or on implantable cardioverter defibrillator~     (ICD) interrogation - between the two ablation groups; secondary endpoints are procedure~     success and safety.~   "
92322|NCT02358733|"~     This is a pilot study which aims to determine the role of IMSI in poor responders.~   "
92323|NCT02358720|"~     This study is a prospective, randomized, monocentre, controlled explorative study in the~     parallel-group design to determine the pain relief after RT of patients with spinal bone~     metastases. Thereby two different techniques were evaluated: single fraction IMRT with 1 x 24~     Gy versus fractionated RT with 10 x 3 Gy. Prior to their enrolment into the study, the~     patients will undergo a staging of the vertebral column in connection with their~     radiation-planning computed tomography (CT) and MRI to measure the myelon dimension. After~     the baseline results have been recorded, the patients will be randomized into one of the two~     groups: single-fraction IMRT 1 x 24 Gy (n = 30) or fractionated RT 10 x 3 Gy (n = 30). The~     target parameters will be measured and recorded at baseline, at the end of RT (t1) and twelve~     weeks (t2) and six months following the end of the irradiation period (t3).~   "
92324|NCT02358707|"~     The specimens from patients as knee osteoarthritis diagnosed who was applied ibuprofen~     phonophoresis will be analyzed.~   "
92325|NCT02358694|"~     This study is being conducted to see if serum-derived bovine immunoglobulin/protein isolate~     (SBI) is safe and well tolerated in pediatric patients with IBS-D.~      Main Hypothesis :Pediatric patients with IBS-D, who take SBI, will have no significant~     adverse events at 4 and 8 weeks and their quality of life will be better than the patients~     who receive placebo.~   "
92326|NCT02358681|"~     Ketorolac is an evidence-based, first-line acute migraine therapy that is commonly used in~     the pediatric population; however, it is typically administered by the intravenous (IV) or~     intramuscular (IM) routes, both of which require a painful and distressing needle stick to~     administer.~      The intranasal (IN) route is a painless and effective way of administering analgesics,~     including ketorolac: IN ketorolac has been shown to be an effective analgesic in adults for~     painful conditions, including acute migraine headaches. However, IN ketorolac has been~     understudied in children, and it is not known how effective it is compared to IV ketorolac,~     which is currently the most common way of administering ketorolac to children. If IN~     ketorolac is shown to be no less effective than IV ketorolac, IN ketorolac may be a viable~     and painless alternative to effectively treat acute migraine headaches in children.~      Therefore, our primary aim is to demonstrate that IN ketorolac is non-inferior to IV~     ketorolac for reducing pain in children with acute migraine headaches.~   "
92327|NCT02358668|"~     This is a single-centre, 16-week, randomized, double-blind, placebo-controlled, 3-treatment~     arm pilot study to evaluate the efficacy and safety of BTI320 in the treatment of high risk~     subjects with pre-diabetes.~      This is a pilot study aiming to test whether taking a medicine named BTI320 that slows down~     carbohydrate absorption in the gut, will lower blood sugar. The study aims to recruit 60~     individuals in Hong Kong. To take part in the study, subjects must have pre-diabetes, that~     is, they have blood sugar levels that are above normal but not reaching diabetes range. The~     medicine BTI320 is currently licensed as a health supplement in Hong Kong and is known~     alternatively as SUGARDOWN®. The investigators are comparing the effectiveness of BTI320~     against a dummy tablet. Both tablets look and taste identical and during the study, subjects~     will not know which of these tablets they are taking. There is a 4 in 5 chance of receiving~     active medication and 1 in 5 chance of receiving placebo. Subjects will be followed up~     closely every 2 to 4 weeks for a period of time up to 22 weeks.~      The study visits will take between 30 minutes to 3 hours, depending on additional checks that~     are required on a particular visit including oral glucose tolerance test and meal tolerance~     test. At visits involving meal tolerance test, subjects will be required to stay for~     approximately 3 hours. In addition, at Visit 2, Visit 4 and 3 days before Visit 7, a~     continuous glucose monitoring system device will be installed.~      Throughout the study period, subjects will return to the study center for check-ups including~     careful enquiry about whether they have developed any side-effects from taking the~     medication, physical examination, as well as blood tests.~   "
92328|NCT02358655|"~     Atrial fibrillation (AF) is a common heart condition, and increases the risk of stroke by six~     times. There are several medications (blood thinners) that can prevent strokes in AF~     patients. Many AF patients present to the emergency department, but about half of AF patients~     leave without prescription of a blood thinner. The study aims to evaluate if adding options~     like giving a patient education kit, encouraging emergency room physicians to prescribe a~     blood thinner and providing a specialized AF clinic to patients will increase the number~     patients receiving blood thinners to prevent strokes.~   "
92403|NCT02357667|"~     This study will evaluate the differences in cardiovascular parameters between women with~     severe preterm preeclampsia and those without preeclampsia using echocardiography and~     maternal blood. The investigators will also look at associations of abnormal cardiovascular~     findings and immediate complications among a high risk cohort of pregnant African American~     women.~   "
92329|NCT02358642|"~     Background: Older people with neurological dysphagia are at risk of recurrent aspiration~     pneumonia. Angiotensin converting enzyme inhibitor (ACEI) has been shown to improve~     swallowing and cough reflexes which may protect dysphagic patients from aspiration pneumonia.~      Hypotheses: ACEI reduces the risk of pneumonia in older patients who are nasogastric tube fed~     because of dysphagia from cerebrovascular diseases.~      Design: Randomized placebo controlled trial~      Method: 302 older patients who have been tube fed for more than two weeks because of~     dysphagia secondary to cerebrovascular diseases are randomized to take half of lisinopril 5~     mg or placebo tablet once daily for 26 weeks. The subjects will be recruited from medical~     wards in Prince of Wales and Shatin Hospitals, and from outpatients of geriatric or speech~     therapy clinics, who have had hospital stay in previous three months. The subjects are~     followed up at week 12 and 26. The primary outcome is the incidence rate of pneumonia as~     determined by pneumonic change on X ray and clinical criteria. The secondary outcomes are~     mortality rate, total episodes of pneumonia over 26 weeks, and swallowing ability defined by~     the Royal Brisbane Hospital Outcome Measure at week 12. Cost effectiveness analysis of public~     health care and personal health care costs will be performed. Intention to treat and log rank~     will be used to analyzed the group differences in outcomes. 60 subjects (30 in each trial~     group) recruited from medical inpatients at Prince of Wales Hospital will undergo swallowing~     videofluoscopy at baseline and week 12 follow-up.~   "
92330|NCT02358629|"~     Trial is to evaluate the safety and performance of the NovaCross™micro-catheter in respect to~     providing additional guidewire support that is expected to allow easier crossing of~     femoropopliteal and infra-popliteal Chronic Total Occlusion (CTO) lesion. The procedure will~     be conducted on a patient diagnosed with a CTO in a peripheral vessel that requires~     revascularization.~   "
92331|NCT02358616|"~     This study is primarily exploratory and is designed to both identify factors that may have~     affected participant adherence to study product in VOICE, and describe how sexual behaviors,~     such as anal sex, may have had an effect on product efficacy. As such there is no specific~     hypothesis that is being tested.~   "
92332|NCT02358603|"~     This study is to collect human activity and ECG data from heart failure (HF) patients to aid~     in the development of a novel chronotropic incompetence (CI) algorithm designed to diagnose~     CI in patients with HF.~   "
92333|NCT02358590|"~     This pilot study evaluates the effect of theory menu-based mini-videos on vitamin D adherence~     in older adult with osteoporosis. Half of participants will watch the videos while the other~     half will receive usual care (treating physician advice).~   "
92334|NCT02358577|"~     To evaluate the feasibility of conducting a randomized controlled trial (RCT) evaluating the~     efficacy of early in-bed cycling in addition to usual care physiotherapy, compared to usual~     care physiotherapy, on functional recovery in critically ill children.~   "
92335|NCT02358564|"~     To better understand the relationship between gut barrier function and the symptomatology and~     pathophysiology of IBS.~   "
92336|NCT02358551|"~     The intrathoracic subclavian venous technique for pacemaker implantation may be associated~     with serious complications. Axillary vein puncture tends to reduce lead implantation~     complications such as pneumothorax and lead crush, but clinical adoption is not widely~     acknowledged, especially in China, although this approach has been proposed for 20 years. The~     major concern is the learning curve for axillary vein puncture and its success rate. The~     investigators try to prove that the success rate of axillary vein puncture is non-inferior to~     subclavian vein puncture, hence to promote the clinical application of axillary vein puncture~     to reduce pacemaker implantation complications.~   "
92337|NCT02358538|"~     To evaluate the efficacy of open-label ganaxolone as adjunctive therapy for uncontrolled~     seizures in female children with PCDH19 mutation and other rare genetic epilepsies in an~     open-label proof-of-concept study.~   "
92338|NCT02358525|"~     The aim of this descriptive study is to examine potential changes regarding inflammatory~     cytokine levels, depressive symptoms and quality of life over the course of the 4-week~     inpatient rehabilitation program which includes a cassette of modalities including~     counseling, psychosocial education and supervised exercise training as a main pillar, and to~     further investigate if there are correlations between changes in immune regulation,~     depressive symptoms and quality of life.~   "
92339|NCT02358512|"~     The purpose of this study is to determine whether intermittent nasogastric enteral feeding,~     rather than conventional continuous enteral feeding, will preserve muscle mass in the~     critically ill (Primary end-point). Such maintenance may translate into improved outcomes~     including reduced length of intensive care unit (ICU) and/or hospital stay, as well as number~     of days on a ventilator. In addition, long-term improvements in health-related quality of~     life and physical activity levels may result in these ICU survivors once they are back in the~     community. Indeed, such benefits could translate into reductions in primary healthcare usage~     and its related costs (secondary end-points).~   "
92340|NCT02358499|"~     The main goal of this study is to see how the body breaks down an antifungal drug named~     posaconazole in children with certain cancers, blood disorders, or transplantation of bone~     marrow or similar blood cells. This study will also help us learn whether a child's age,~     genetics, or disease affect how well the body breaks down posaconazole.~   "
92341|NCT02358486|"~     The aim of the study is to investigate the effect of acupuncture on functional dyspepsia~     compared with sham control. The study aims to clarify the mechanism of acupuncture by~     assessing functional magnetic resonance imaging and metabolomics.~   "
92342|NCT02358473|"~     The purpose of this study is to evaluate the safety of mogamulizumab in combination with~     docetaxel in adult subjects with previously treated locally advanced or metastatic non-small~     cell lung cancer.~   "
92343|NCT02358460|"~     A randomised controlled trial comparing volume-targeted ventilation to pressure-limited~     ventilation in infants born at or near term.~   "
92344|NCT02358447|"~     By the comparison of two operation methods navigated and non-navigated TKR with SPECT/CT we~     want to show wich method has the better outcome.~   "
92408|NCT02357602|"~     Purpose:~      The purpose of this study is to characterize the dose-proportionality in the distribution of~     tenofovir alafenamide (TAF) and tenofovir (TFV) in plasma and mucosal tissues, and~     TFV-diphosphate (TFV-DP) in peripheral blood mononuclear cells (PBMCs) and mucosal tissues of~     healthy female subjects following a single oral dose of GS-7430 at 5mg, 10mg, and 25mg.~   "
92345|NCT02358434|"~     The proposed study is a retrospective, observational study. A group of 5 subjects with the~     AttuneTM cruciate retaining (CR) fixed bearing total knee arthroplasty (TKA) are analysed~     during level walking, a deep knee bend, sitting down onto a chair, standing up from a chair~     and stair descent at least 12 months post-operatively, in terms of 3D fluoroscopic assessed~     tibio-femoral TKA motion as well as simultaneous skin marker assessed whole leg motion and~     ground reaction forces. The obtained information helps the manufacturer (DePuy) to evaluate,~     bring to market and advance the implant. Furthermore the information will be integrated in a~     model, which will be developed at the Center for Orthopaedic Engineering, University of~     Denver. By means of this model, different conditions such as the use of an advanced~     prosthesis design can be simulated and tested.~      The objective of this study is in a first step to demonstrate the capability of data~     collection and analysis of level gait, deep knee bend, sitting down onto a chair, standing up~     from a chair and stair descent on a limited sample size of five subjects. Secondly to~     quantify and describe the three-dimensional kinematics for the cruciate retaining (CR), fixed~     bearing AttuneTM TKA during daily activities such as those mentioned.~   "
92346|NCT02358421|"~     Polycystic ovarian syndrome (PCOS) patients have an increased risk of ovarian~     hyperstimulation syndrome (OHSS) after assisted reproduction techniques (ART). In addition,~     these women have a high risk of develop further metabolic disorders. Rotterdam criteria~     defined by the European Society of Human Reproduction and Endocrinology (ESHRE) are used for~     the diagnosis of PCOS.~      The aim of this study is both to determine the prevalence of PCOS in infertile patients who~     require ART in our Center and to evaluate the usefulness of each specific diagnosis criterium~     within Rotterdam criteria of PCOS as predictor of risk of OHSS. It also seeks to establish a~     cohort of patients identified according to specific Rotterdam criteria of PCOS to assess the~     incidence of long term complications.~   "
92347|NCT02358408|"~     The study consists of 2 parts:~      The objective of part 1 of this study is the performance of a short evaluation of system~     accuracy for 25 subjects in order to familiarize the study personnel with the study BGMS to~     be used during the planned evaluation of system accuracy (see IDT-1416-BL (Part 2)), ensure~     that the Karajishi meters are fully functioning, assure and document the accuracy of the~     comparison method, evaluate and validate the processes and procedures of the study~     methodology. The objective of part 2 of this study is the evaluation of system accuracy~     following ISO 15197:2013 (E), clause 6.3 in which accuracy requirements and applicable test~     procedures for blood glucose monitoring systems intended for self-monitoring of blood glucose~     by patients are stipulated.~      This study will be performed for Karajishi Contour and Karajishi Contour TS (manufacturer:~     Bayer Healthcare Diabetes Care) with 3 reagent system lots for each BGMS.~   "
92348|NCT02358395|"~     This is an open-label, multicenter, phase 1 study of BBI608 in combination with Sorafenib.~     This study population is adult Japanese patients with advanced hepatocellular carcinoma in~     Sorafenib combination therapy.~   "
92349|NCT02358382|"~     The purpose of the study is to determine whether it is possible to manage the flow of blood~     through blood vessels using varying levels of carbon dioxide during cardiac surgery, and what~     effect this has on how well the major organs of the body work.~   "
92350|NCT02358369|"~     The Bimatoprost Ocular Insert is intended to provide sustained delivery of bimatoprost to the~     ocular surface to lower the intraocular pressure (IOP) in patients with open-angle glaucoma~     or ocular hypertension.~      This study will evaluate the safety and efficacy of two different doses of the Bimatoprost~     Ocular Insert, compared to an active control arm with timolol ophthalmic solution (0.5%).~   "
92351|NCT02358356|"~     Two parallel phase II randomized open label trials of Lutetium-177 Octreotate~     (177Lu‐Octreotate) peptide receptor radionuclide therapy (PRRT) and capecitabine~     (CAP)/temozolomide (TEM) chemotherapy (chemo): (i) versus CAPTEM alone in the treatment of~     low to intermediate grade pancreatic neuroendocrine tumours (pNETs); (ii) versus PRRT alone~     in the treatment of low to intermediate grade mid gut neuroendocrine tumours (mNETs).~   "
92352|NCT02358343|"~     Patients whose kidneys fail generally require dialysis treatments to sustain life. The~     ability of patients to make major adjustments in their lives for dialysis is hampered by~     depression that affects almost one-quarter of such individuals. There are no studies that~     have adequately tested whether treatment of depression is effective in dialysis patients and~     if there is any difference between the response to the two most commonly available forms of~     treatment, psychotherapy and anti-depressant drug therapy.~      To fill this important gap in the investigators knowledge, the investigators propose to~     undertake (1) a randomized controlled clinical trial of 200 patients to test whether an~     engagement interview will result in a higher proportion of dialysis patients accepting~     treatment for depression; and (2) a randomized controlled clinical trial of 120 patients to~     determine whether there is any difference in the likelihood of improvement of depressive~     symptoms with psychotherapy or drug therapy among dialysis patients with depression. Patients~     in these studies will be enrolled from among individuals receiving care in 50 dialysis~     facilities in three metropolitan areas - Seattle, Dallas, and Albuquerque. The research~     proposal has been developed with the support of patients, caregivers, and stakeholders to~     ensure that the findings from the study are relevant to them and can be readily implemented~     in day-to-day clinical practice. Hence, the engagement interview and psychotherapy will be~     delivered in a dialysis facility to ease the burden on patients, and the dose of the study~     drug will be changed in partnership with the study participants. In addition to depressive~     symptoms, the effect of treatment on other meaningful outcomes such as fatigue and sleep will~     be determined.~      The two forms of treatment for depression being tested in this clinical trial are very~     different from each other and patients differ with regards to the treatment option preferable~     and/or available to them. Successful completion of the clinical trial will provide patients,~     caregivers, and other stakeholders with the information that they would need when faced with~     a diagnosis of depression in patients undergoing hemodialysis. This will allow patients to~     select evidence-based treatments to improve outcomes that are relevant to them.~   "
92353|NCT02358330|"~     Smoking is the leading preventable cause of cancer mortality in the US. Despite its profound~     health and economic costs, smoking treatment is infrequently provided in healthcare settings,~     and when provided, it is not sufficiently effective. To address this, this project will~     develop and evaluate more efficient electronic health record (EHR) methods to identify~     smokers and engage them in evidence-based treatment.~   "
92354|NCT02358317|"~     The purpose of this pilot study is to determine whether a video-game based motor training can~     affect postural stability, daily living skills, autism symptoms, and white matter~     microstructure of the corticospinal tract in adolescents with Autism Spectrum Disorder (ASD).~   "
92355|NCT02358304|"~     The main objective of this randomised clinical trial is to is to compare the frequency of~     recurrence between patients who received nasal spray calcitonin after curettage of Central~     Giant Cell Granuloma and without it.~   "
92356|NCT02358291|"~     In our study, a multicenter randomized controlled，single blind trial will be performed to~     evaluate the effectiveness and safety of these three procedures for the treatment of~     symptomatic lumbar disc herniation.~   "
92357|NCT02358278|"~     The goal of this study is to determine the incidence and characteristics of Emergence~     Delirium (ED) in children aged 0 - 13 undergoing general anesthesia and being taken care of~     at the paediatric PACU of the Charité Campus Virchow-Clinic. Therefore the Paediatric~     Anesthesia Emergence Delirium Scale (PAED) is used. In order to measure the patient's pain~     level, age-appropriate pain scales (CHIPPS or FPS-R) are applied. Risk factors for the~     occurrence of ED are to be determined and therapeutic approaches in case of an occurring ED~     are to be evaluated. Finally the future implementation of ED-monitoring in the PACU is to be~     prepared.~   "
92358|NCT02358265|"~     To compare CSU disease activity at the end of the follow up phase between patients that had~     been treated daily continuously vs. on-demand in the treatment phase~   "
92359|NCT02358252|"~     This research investigated the heart rate variability (HRV) and stroke patients' orthostatic~     hypotension in hospitalized stroke patients accompanied with dizziness at varied tilting~     angle controlled by tilting table.~   "
92360|NCT02358239|"~     Dizziness and vertigo account for roughly 4% of chief symptoms in the emergency department~     (ED). Pharmacological therapy is often solicited for these symptoms, such as vestibular~     suppressants, anti-emetics and benzodiazepines. However, every medication is accompanied with~     unavoidable side-effects. To the best of the investigators knowledge, no papers surveyed~     assess the feasibility of applying acupuncture as an emergent intervention means to the~     treatment of dizziness and vertigo. The investigators study targeted on filling in this gap~     by performing a clinical control trial to evaluate the efficacy and safety of traditional~     Chinese medicine - acupuncture - in treating patients with dizziness and vertigo in ED.~   "
92361|NCT02358226|"~     The purpose of this study is to test the efficacy of randomizing all young men in a~     neighborhood to receive: 1) soccer training; 2) soccer and vocational training; or 3) a~     control condition, as a means to engage young men in HIV prevention. The investigators~     hypothesize that the intervention will reduce young men's substance use and increase HIV~     testing.~   "
92362|NCT02358213|"~     This aim of this study is to compare the reproducibility of reading of five international~     experts concerning the anomalies of the salivary glands.~      The reproducibility is measure on patients and not on recorded data.~   "
92363|NCT02358200|"~     Open label, non-randomized, dose escalation and expansion Phase Ia/b trial to evaluate the~     safety of the combination of BMN 673 and carboplatin, and subsequently BMN 673 in combination~     with paclitaxel and carboplatin to determine the recommended Phase II dose of the~     combination.~   "
92364|NCT02358187|"~     The study will assess the immunogenicity, safety and preliminary clinical efficacy of the~     GAA/TT-peptide vaccine and poly-ICLC in HLA-A2+ children with unresectable low-grade gliomas~     that have received at least two chemotherapy/biologic regimens. Radiation therapy counts as~     one biologic regimen, but patients may not have received radiation to the index lesion within~     1 year of enrollment.~   "
92365|NCT02358174|"~     An association between hemorrhoidal disease and matrix metalloproteinases (MMPs) has been~     described previously. MMPs regulate extracellular structural proteins and tissue remodeling.~     Neutrophil gelatinase-associated lipocalin (NGAL) is involved in the regulation of MMP~     activity. The aim of this work was to study the relationship between the levels of MMPs and~     NGAL and different stages hemorrhoids.~      The study provides potentially important insights to the understanding of the natural history~     of Hemorrhoids and MMPs and NGAL regulation.~   "
92366|NCT02358161|"~     The 5 year survival of patients with locally advanced or metastatic pancreatic cancer is less~     than 5 %. Since the introduction of gemcitabine, further advances in therapy in the~     advanced/metastatic setting have been extremely slow. Numerous phase III studies have~     evaluated different gemcitabine-based regimens as first-line therapy, but in most cases, any~     observed benefits have been small and restricted to patients with a good performance status~     (PS). Recently two new chemotherapy combination schedules, FOLFIRINOX and Gemcitabine +~     nab-paclitaxel demonstrated a significant survival improvement compared to gemcitabine alone.~     Nab-paclitaxel is especially interesting because it is able to break-down the tumor matrix~     and increases the concentration of cytotoxic drugs in the tumor.~      Our study will explore the modification of the desmoplastic reaction seen in pancreatic~     cancer using two approaches, targeting tumor stroma by nab-paclitaxel and the hedgehog~     inhibitor LDE225 and targeting the tumor cells with gemcitabine and nab-paclitaxel.~   "
92367|NCT02358148|"~     This prospective observational study will evaluate and compare the sensitivity and~     specificity of the Modified TIMI, HEART and SACS Scores for accurately predicting the~     presence and absence of obstructive coronary artery disease (OCAD) as diagnosed during~     coronary angiography in the cardiac catheterization suite. In addition, we plan to determine~     if a variant of SACS, HEART, TIMI, or a hybrid score resulting from combining formulas from~     two or all three scores yields a new tool that exceeds the predictive performance of all~     three current models for determining the absence or presence of OCAD.~   "
92368|NCT02358135|"~     The investigators propose to evaluate whether an innovative collaborative connected health~     (CCH) model increases access to specialists and improves patient outcomes. CCH offers~     multiple modalities for patients and primary care providers (PCPs) to access dermatologists~     online directly and asynchronously to maximize effectiveness in a real-world setting. CCH~     also fosters team care and patient engagement through active sharing of management plans and~     multidirectional, informed communication among patients, PCPs, and dermatologists. The~     specific aims of the proposal are to (1) determine whether the CCH model results in~     equivalent improvements in psoriasis disease severity compared to in-person care, (2)~     determine whether the CCH model results in equivalent improvements in quality of life and~     mental health compared to in-person care, and (3) assess whether the CCH model provides~     better access to care than in-person care.~   "
92369|NCT02358122|"~     A dietary intervention study designed as a randomized, controlled, parallel intervention of~     6-weeks duration. A total of 75 participants will be included in the study and randomly~     allocated to one of three interventions (refined wheat, whoelgrain wheat or wholegrain rye).~     Clinincal examinations including anthropometric assessment, fecal, urine and fastign blood~     sampling, dietary assessment and a meal challenge will be done before (week 0) and after~     (week 6) the intervention. At timepoints week 0, 2, 4 and 6 questionnaires will be filled in~     concerning satisfaction with diet and gastrointestinal symptoms.~   "
92370|NCT02358109|"~     Spain is the second country in the world that consume more drugs. The average drug~     expenditure per capita in Andalucía during 2011 was 219.2 €. This drug spending increases~     during the perimenopausal period. According to the Study of the Economic Impact of Sport on~     Health Spending of the Ministry of Health of the Generalitat of Catalonia, for every euro~     invested in sports promotion 50 euros are saved in health spending accumulated over 15 years.~     The main objectives of this project are: i) To analyze the (cost-effectiveness) effect of an~     exercise program on the prescription of drugs in a sample of Andalusian women aged 45-60~     years. ii ) To study the level of physical activity and sedentarism (measured objectively by~     accelerometry ) , functional capacity , quality of life and clinical profile of this~     population. iii ) To analyze the relationship between levels of physical activity /~     sedentarism and pharmaceutical expenditure. In the present project, an exercise program aimed~     at minimizing symptoms and health problems associated with the perimenopausal period will be~     performed (Dyslipidemia, diabetes, anxiety, depression, quality of life, quality of sleep,~     obesity, osteoporosis and cardiovascular disease). A total of 160 perimenopausal women will~     be randomly assigned to the intervention group exercise (n = 80 ) or to the usual care group~     (n = 80). Participants in the intervention group will train 3 days / week ( 60 min per~     session ) for 16 weeks.~      With the analysis of the results of this project new patterns of objective work as well as~     the most significant practical resources for the design of a master plan may be determined.~     Results are expected to be able to shed some light on the implementation of programs of~     health promotion that are both time beneficial for the Andalusian Public Health and for the~     family , institutional and community economy.~   "
92371|NCT02358096|"~     The purpose of this study is to evaluate the efficacy of ASP8232 in reducing Urinary Albumin~     to Creatinine Ratio (UACR) in subjects with Type 2 Diabetes Mellitus (T2DM) and Chronic~     Kidney Disease (CKD) at 12 weeks compared to placebo.~   "
92372|NCT02358083|"~     The purpose of this study was to determine whether messages about 1. relative risk of~     vaccination vs. other activities and 2. strength of doctor's recommendation influenced~     parental intention to get own child vaccinated against human papillomavirus (HPV) or~     Influenza.~   "
92373|NCT02358070|"~     The purpose of this study is:~        -  to investigate the risk factors of HCC among Americans with focus on lifestyle factors~          and energy balance.~        -  to identify single nucleotide polymorphisms (SNPs) and haplotypes that are associated~          with HCC risk through a genome-wide search.~        -  to assess if genetic susceptibility differs by hepatitis virus infection or lifestyle~          factors, and to explore if there are interplays or effect modifications between genetic~          factors and viral infection or lifestyle factors.~   "
92374|NCT02358057|"~     The main objective is to determine if dexmedetomidine combine with alfentanil allow a level~     of conscious sedation within maximum security conditions in an emergency department.~      Patients included in the study will receive an injection of dexmedetomidine via a TIVA~     Injectomat Agilia, specially programmed for the injection of dexmedetomidine.~      Patients will also receive a dose of alfentanil, 1 minute before the technical act.~   "
92375|NCT02358044|"~     This is a study comparing grazoprevir (MK-5172) plus elbasvir (MK-8742) treatment with~     sofosbuvir (SOF) plus Pegylated Interferon plus Ribavirin (RBV) [PR] treatment in~     treatment-naïve and prior PR treatment failure participants with chronic Hepatitis C Virus~     (HCV) genotype (GT)1, GT4, or GT6 infection. The primary objectives are to compare efficacy~     (assessed by the percentage of participants achieving sustained virologic response 12 weeks~     after ending study treatment [SVR12]) and safety between the grazoprevir plus elbasvir~     treatment arm and the SOF plus PR treatment arm. The primary hypothesis is that the~     percentage of participants achieving SVR12 in the grazoprevir plus elbasvir treatment arm is~     non-inferior to that in the SOF plus PR treatment arm.~   "
92376|NCT02358031|"~     Participants with recurrent or metastatic (R/M) squamous cell cancer of the head and neck~     (HNSCC) will be randomly assigned to receive pembrolizumab alone, or pembrolizumab + a~     platinum-based drug (cisplatin or carboplatin) + 5-Fluorouracil (5-FU), or cetuximab + a~     platinum-based drug (cisplatin or carboplatin) + 5-FU. The primary study hypothesis is that~     pembrolizumab or pembrolizumab in combination with chemotherapy prolongs progression free~     survival and overall survival compared to standard treatment.~   "
92377|NCT02358018|"~     The purpose of this study is to use a new type of scan, called 68Ga-DOTATOC PET/CT scan,~     instead of OctreoScan, the standard scan, to diagnose, monitor and manage your tumor.~     68Ga-DOTATOC is an improved imaging agent being routinely used in many centers outside the~     USA, with better tumor detection than with OctreoScan.~   "
92378|NCT02358005|"~     Recently, It is known that the efficacy of botulinum toxin type A (BTX-A) with extracorporeal~     shock wave therapy (ESWT) is greater than that of BTX-A with electrical stimulation in the~     management of post-stroke spasticity of the upper limb. However, it was not determined which~     dose of ESWT is optimal as a adjuvant therapy after BTX-A injection on the upper limb in~     patients with stroke. Therefore, the aim of this study is to evaluate the optimal dose of~     ESWT after botulinum toxin type A injection for post-stroke spasticity~   "
92379|NCT02357992|"~     The goal of this clinical research study is to evaluate the outcome of a standard radiation~     treatment called stereotactic radiotherapy (SRT) for NSCLC.~      Specifically, researchers want to learn if standard SRT has as good of an outcome at 3 years~     after the procedure. The safety of the study treatment will also be analyzed.~   "
92380|NCT02357979|"~     The objective of this clinical study is to evaluate whether the use of the new CO2 - 9.3μm~     short-pulsed laser increases the caries resistance of occlusal pit and fissure surfaces in~     patients in addition to fluoride therapy. This will be quantified by visual exams with the~     International Caries Detection and Assessment System (ICDAS II), SOPROLIFE daylight and blue~     fluorescence, and DIAGNOdent Laser Light-induced Fluorescence. This is a randomized, single~     blind, prospective, split mouth controlled, clinical trial over 12 months.~   "
92381|NCT02357966|"~     This study will evaluate the maximum safe dose of the true human monoclonal antibody, 514G3,~     in the treatment of patients with Staphylococcus Aureus bacteremia. Preliminary evidence of~     efficacy will be evaluated as well. Patients will receive 514G3 plus antibiotics or placebo~     plus antibiotics in approximately a 3 to 1 ratio.~   "
92404|NCT02357654|"~     During IVF cycles an embryo is generally placed into the uterine cavity between 3 and 5 days~     after fertilization. For a successful pregnancy to take place, that embryo must then implant~     in the properly primed and staged endometrium, which subsequently must continue to develop to~     accommodate the growing and maturing embryo and then fetus. This process is normally~     regulated by hormonal interactions between the fetal, endometrial and luteal tissue. It has~     been found that after IVF additional support for the endometrium with progesterone improves~     implantation and subsequent live birth rates in IVF cycle . Recent data has shown that~     additional supplementation with a single administration of a GnRH agonist around the time the~     time of embryo transfer may further enhance these rates .~   "
92382|NCT02357953|"~     Perioperative hemodynamic optimization requires monitoring adapted to the risks of the~     surgery and the patient. The investigators currently use a local hemodynamic protocol based~     on the data of the literature. According to this protocol, specific patients may require~     cardiac index and central venous oxygen saturation monitoring. the investigators chose to~     monitor the cardiac index (CI) with the transpulmonary thermodilution technique (TPTD)~     (PiCCO, Pulsion Medical System, Munich, Allemagne). The technique is based on the injection~     of a cooled bolus of saline into a central vein with a central venous catheter (CVC). The~     variation of temperature is measured with an arterial femoral catheter and allows the~     assessment of the cardiac output according to Stewart-Hamilton's theory. Many studies showed~     the reliability of this technique (Bein J Cardio Thorac Vasc Anesth 2004, Buhre Cardio thorac~     vasc anesth 1999, Felbinger J Clin ANesth 2005, Felbinger TW J Clin Anetsh 2002, Godie O Ann~     Thorac Surg 1999).~      In our institute, most of the patients are fitted with a port for chemotherapy or parenteral~     nutrition. When PiCCO monitoring is necessary, a central venous catheter is inserted on the~     opposite side of the permanent implantable venous port. Indeed, insertion of the CVC can be~     more difficult because of the port. It may be interesting to use the port for TPTD in order~     to avoid the insertion of a new CVC. This would be possible only if the measurement of CI by~     the port was as reliable as the classical measurement with a CVC.~      The aim of this study was to assess whether measurement of the CI by TPTD was possible and~     reliable via the port. The investigators conducted a prospective study comparing the~     measurement of the CI by TPTD before and after fluid challenge via the port versus the CVC.~   "
92383|NCT02357940|"~     The purpose of this 14-day, two phase clinical study is to test the tolerance of a new~     over-the-counter moisturizing balm on subjects with eczema.~   "
92384|NCT02357927|"~     This is a controlled trial of the Mini-AFTERc intervention to reduce fears of recurrence in~     breast cancer patients. The sample will be collected in NHS Fife Breast Cancer Services~     (n=32). The intervention is a short telephone counseling service of 20 minutes delivered by~     the patient's breast cancer specialist nurse. Dependent measures consist of the ACCRE FoR 4~     item measure and the EORTC Intervention overall satisfaction scale.~   "
92385|NCT02357914|"~     Shoulder pain is very common in people with spinal cord injury (SCI). Persons with high-level~     paraplegia have higher chances to suffer shoulder pain and injury than those with lower-level~     paraplegia due to the shoulder muscle imbalance. As people with SCI overuse the shoulder~     during routine daily activities, the onset of pain or injury lead to increased healthcare~     expenses, limitation in activity, depression, decreased participation, and reduced quality of~     life. One of the main reasons of shoulder pain is believed to have a altered scapular~     movement. To clarify the mechanism of the shoulder pain and injury, comprehensive~     understanding of three-dimensional scapular kinematics is required. Ultrasound is a low-cost~     and non-invasive imaging system and has been used to diagnose the shoulder pain and injury in~     individuals with SCI. A freehand ultrasound (FUS) combining ultrasound with motion capture~     system to evaluate scapular movement was developed and presented favorable results in~     able-bodied population. The purpose of this study is to compare the FUS and widely used~     skin-based method against a radiographic based gold standard in people with paraplegia, and~     to elucidate the relationship among scapular movement and shoulder pain, pathology. This~     study will also allow us to gain more understanding of how level of injury influences the~     scapular behavior during functional activities. The investigators believe more severe~     shoulder pain and pathology will be associated with greater abnormal scapular movement. The~     investigators also believe that people with high-level paraplegia will have greater scapular~     abnormality than people with low-level paraplegia during arm elevation and weight relief~     raise tasks. By completing this study, the investigators will expect to deliver a reliable~     and valid tool to evaluate scapular movement and gain a better understanding how the altered~     scapular movement is related to shoulder pain and pathology. The investigators will also~     learn how the level of injury affects the scapular behavior during functional activities. The~     results of this study may help the shoulder pain management leading to the improvement in the~     quality of life of individuals with SCI.~   "
92386|NCT02357901|"~     This is a randomized, double-blind, placebo controlled, multicenter study in male and female~     participants who are seeking treatment for opioid use disorder.~   "
92387|NCT02357888|"~     The purpose of this study is to evaluate the reduction of craving and its time course after~     administration of V0018 2.5 mg compared to placebo in healthy highly dependant smokers.~   "
92388|NCT02357862|"~     The purpose of this study is to evaluate the impact of isolated mitral valve annuloplasty on~     the geometry and the function of the tricuspid valve complex.~   "
92389|NCT02357849|"~     We are conducting a randomized, 24-week, double-blind study, comparing fluoxetine with~     aripiprazole in 48 patients with attenuated positive symptoms at a level of at least moderate~     severity.~   "
92390|NCT02357836|"~     The purpose of this study is to determine the pharmacodynamics effects of itraconazole in~     early-stage non-small cell lung cancer.~   "
92391|NCT02357823|"~     Streptococcus pneumoniae is a cause of high morbidity and mortality in HIV-positive subjects,~     representing the leading etiological agent of severe bacterial pneumonia. International~     guidelines recommend that HIV positive patients aged >=19 years, who are 13-valent conjugate~     vaccine (PCV13) naïve, should receive a single dose of PCV13. Pneumococcal polysaccharide~     vaccine 23-valent (PPV23) should be given >=8 weeks after indicated dose of PCV13, and a~     second dose of PPV23 should be given 5 years later. For those who previously received PPV23,~     PCV13 should be administered >=1 year after the last PPV23 dose. HIV infection affects~     humoral immunity both through reduced T-cell help and changes in the B-cell compartment.~     Neither amount of circulating memory B cells nor their functions are restored by~     antiretroviral therapy: this may affect antibody mediated immunity, even in well-treated HIV~     patients. In asplenic childrens a single dose of PCV13 seems sufficient to restore the pool~     of anti-pneumococcal polysaccharides IgG memory B cells. In adults, it has been reported that~     a single dose of 7-valent pneumococcal conjugate vaccine induces significant increases in~     serotype-specific memory B-cell populations, conversely, immunization with PPV23 seems to~     decrease memory B-cell frequency. However, data on immunological response after PCV13 in HIV~     positive adults are still scanty and the optimal pneumococcal prophylaxis strategy needs~     further investigation. Number of PCV13 doses is actually demanded to clinical judgment for~     each patient; also current Italian indications recommend at least one dose, but till 3 doses~     seem to be suggested for immunocompromised patients. Present study aims to investigate short~     and long term immunological response after different standard vaccine schedule and to~     evaluate pneumococcal nasopharyngeal colonization in vaccinated patients.~   "
92392|NCT02357810|"~     The purpose of this clinical research study is to learn if pazopanib when given in~     combination with topotecan can help to control sarcomas. The safety of this drug combination~     will also be studied. Pazopanib hydrochloride and topotecan hydrochloride may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth.~   "
92393|NCT02357797|"~     This is a 16-week, randomized, double-blind, parallel group, placebo-controlled study~     comparing adjunctive vortioxetine with identically appearing adjunctive placebo pills in 88~     stable patients with a research diagnosis of schizophrenia determined with the Structured~     Clinical Interview for DSM (SCID). Patient randomization will be stratified by illness~     duration (i.e., </=5 years and >5 years) in order to allow for post-hoc analyses examining~     whether earlier illness moderates greater negative and /or cognitive symptom reduction in~     response to vortioxetine.~   "
92405|NCT02357641|"~     Examination of probable distinction between cardiac or non- cardiac thoracal disorder via~     echocardiographic myocardial strain analysis~   "
92394|NCT02357784|"~     Women with Dual Incontinence (DI) (both Urinary Incontinence (UI) and Fecal Incontinence~     (FI)) often have more bothersome symptoms, quality of life impact, and sexual dysfunction~     than those with just UI or FI. In many situations, DI is the result of a failure of~     communication between the brain and the sacral nerve, which controls the bladder, bowel, and~     pelvic floor. The only currently available treatment with level 1 effectiveness data for the~     treatment of BOTH UI and FI is called Sacral Neuromodulation (SNM). Sacral Neuromodulation is~     a standard of care treatment that involves surgically implanting a device in to a patient's~     body to target communication issues between their brain and bladder/bowel. Because the exact~     mechanism of action of SNM remains unclear, this study aims to better understand how SNM~     affects the nerves of patients with DI. Patients who are already planning on undergoing SNM~     device implantation will be recruited to this study. Study participants will undergo Current~     Perception Threshold (CPT) Testing and fill out questionnaires before SNM and 3 months after~     their SNM treatment. CPT Testing uses mild electrical stimulation in the urethra and rectum~     to measure and quantify the amount of physical stimuli required for the nerves in the pelvic~     floor to sense a stimulus. By learning more about nerve function in patients with DI, the~     investigators hope to find a way to screen patients before treatment with SNM to make sure~     the treatment will be effective for that individual.~   "
92395|NCT02357771|"~     Advances in orthodontics have improved the quality of appliances and treatment protocols,~     raising the standard of patient care. However, enamel demineralization is still a problem~     associated with orthodontic treatment, leading to the formation of white spot lesions; this~     is a grave concern to orthodontists and patients.~      The overall prevalence of white spot lesions among orthodontic patients has been reported to~     be between 4.9% and 84%.1 When basic oral hygiene is poor, orthodontic appliances create~     areas of plaque stagnation, especially around brackets, bands, wires, and other attachments.~     Levels of acidogenic bacteria, present in the plaque, notably Streptococcus mutans (S~     mutans), are higher in orthodontic patients than in non-orthodontic patients.~      This causes demineralization around the brackets and leads to white spot lesions. They are~     most prevalent around the cervical region of bands in the posterior region, whereas in the~     anterior region, the lateral incisors in both arches, followed by the canines, are most~     commonly affected.~   "
92396|NCT02357758|"~     Approximately, 3% of males and 8% of females will develop a urinary tract infection (UTI)~     during childhood, and most of these will be effectively treated by short-term antibiotic~     therapy. A subset of these children (20-48%), will develop recurrent UTI (RUTI), which may~     have long-term effects in the form of hypertension or renal damage.~      In an effort to prevent RUTIs physicians prescribe sulfamethoxazole-trimethoprim (Septra) or~     nitrofurantoin as low dose antibiotic prophylaxis. However, recent evidence suggests that~     during prophylactic therapy the body is exposed to antibiotic levels capable of increasing~     antibiotic resistance and bacterial virulence. This has been shown to be true in the~     uropathogens E. coli and Staphylococcus saprophyticus, yet it is not known if Enterococcus~     sp. demonstrate similar mechanisms. Additionally, antibiotics have been shown to disrupt the~     natural balance of the human microbiome, potentially leading to major long term problems.~      As a uropathogen, enterococci consistently rank in the top 3 causes of RUTI, especially in~     children under 3 years of age. Additionally, Enterococcus is notorious for developing~     antibiotic resistance and studies have shown that children with enterococcal UTIs exhibit a~     higher rate of recurrence than those with non-enterococcal UTIs.~      The investigators hypothesize the current practice of antibiotic prophylaxis in children with~     RUTI is detrimental and can change the bacterial and sensitivity profiles of these patients.~   "
92397|NCT02357745|"~     Neopterin has been identified as a marker of cellular immune system activation. It is~     synthesized by macrophages upon stimulation with the cytokine interferon-gamma and is~     indicative of a pro-inflammatory immune status. Neopterin concentration increases with~     increasing severity of periodontal disease in diverse body fluids like Urine, Saliva and~     Plasma. Hence Neopterin can be considered as an important inflammatory marker in periodontal~     disease as well as other systemic diseases.~   "
92398|NCT02357732|"~     This study evaluates nivolumab in combination drug treatments involving 1) nivolumab and~     dabrafenib 2) nivolumab and trametinib and 3) nivolumab, dabrafenib and trametinib in~     patients with BRAF or NRAS-mutated metastatic melanoma.~   "
92399|NCT02357719|"~     The high prevalence (9% in men and 4% in women) of sleep apnea / hypopnea syndrome (SAHS) in~     adults is now well documented as well as its cardiovascular repercussions. Previous studies~     showed a conclusive link between SAHS and severe cardiovascular diseases such as~     hypertension, myocardial infarction, heart failure and stroke.Then, SAHS is a public health~     issue in adults.~      In this context, early detection of such a disease is crucial if the management is tailored~     to the patient, the practitioner's choice of therapy moving towards continuous positive~     airway pressure (CPAP) or mandibular advancement device. The detection is based on full~     nocturnal polysomnography or polygraphic recordings. Polysomnography remains the gold~     standard but it is a time consuming and costly examination. Polygraphic recording is a test~     that allows simplified the diagnosis of severe patients, but may not be sufficient for mild~     form of SAHS. Thus, the SAHS is a pathology under-diagnosed and under-treated. The validation~     of a technique for identifying patients most at risk to either limit the number of~     polysomnographic examination is requested.~   "
92400|NCT02357706|"~     Little is understood about how different auto-adjusting PAP devices operate. The purpose of~     this evaluation is to compare two devices in a randomised two night PSG trial.~   "
92401|NCT02357693|"~     The purpose of this study is to determine whether patients at high risk for postoperative~     nausea and vomiting can benefit from aprepitant, ondansetron and dexamethasone in the~     perioperative period.~   "
92402|NCT02357680|"~     This study will investigate the effect of diaries written by relatives for critically ill~     patients on the risk of posttraumatic stress symptoms.~      Utilizing a randomized controlled design pairs of one patient and one relative will be~     assigned to either diary intervention or standard care. The effect of the diary will be~     evaluated using a questionnaire 3 months post charge.~      The results of this study will add to the body of knowledge on how diaries may help critical~     care survivors and their relatives to proceed with their lives.~   "
92406|NCT02357628|"~     The investigators believe that regulated oxygen-enriched negative Pressure Therapy (RO-NPT)~     will be beneficial in the reduction or elimination of anaerobic infection in hard-to-heal~     soft tissue wounds.~   "
92409|NCT02357589|"~     The 3D-systems have emerged also to the world of surgery, and the three-dimensional~     laparoscopic systems are gradually entering the operating rooms. In the normal laparoscopy~     there are only two-dimensional view, which is somewhat challenging when operating in~     three-dimensional environment. Even though the 3D-systems have been widely studied in~     laboratory circumstances, there are still no evidence of benefits of 3D vs 2D in clinical~     point of view and no prospective randomized trials have been published. Therefore, the~     purpose of this study is to investigate is there something to gain in changing into 3D~     laparoscopic system for cholecystectomy (LCC).~   "
92410|NCT02357576|"~     Parenteral nutrition-associated cholestasis (PNAC) and liver disease (PNALD) are associated~     with significant morbidity and mortality in neonates and is felt to be exacerbated by~     soybean-based lipid emulsions. Much research is currently being directed at identifying ways~     to reduce this risk. Reduction of the dose of soybean-based lipid given as a component of~     parenteral nutrition is one possible strategy. In this study we will compare standard dosing~     of soybean-based lipid (up to 3/kg/day) with a minimized dose (1 g/kg/day) and evaluate for~     the development of cholestasis and adequate growth between the two groups. Longterm followup~     will include an assessment of neurodevelopmental outcomes at 12 and 24 months of age.~      Funding source - FDA OOPD~   "
92411|NCT02357563|"~     Submucosal fibroid grow inside the uterine cavity and are associated with menorrhagia,~     abnormal uterine bleeding (AUB) and infertility. Type II (G2) fibroids often require more~     surgeries due to their particular position in the myometrium. Surgery, moreover, should~     always be tailored, particularly in patients wishing to conceive, to preserve the integrity~     of the myometrium. Preoperative use of GnRH agonist appears to be relevant and beneficial in~     patients with submucous fibroids, but are associated with several side effects. the eighty~     percent of patients treated by UPA showed a clinically meaningful reduction of more than 25%~     in fibroid volume, and 50% of patients a reduction of 50%. fibroid volume reduction appeared~     to be maintained for 6 months after the end of UPA treatment~   "
92412|NCT02357550|"~     This project tend to investigate the affection of ketone bodies on brain metabolism. This~     will be done by measuring human cerebral uptake of energy substrates, together with~     functional parameters, using PET imaging and appropriate radiotracers under hyperketonemia in~     healthy subjects by ketone infusion.~      Hypotheses~        1. Increased levels of ketone bodies in healthy subjects leads to decreased glucose uptake~          by brain cells contributing to hyperglycaemia.~        2. Increased levels of ketone bodies in healthy subjects leads to increased cerebral blood~          flow.~        3. Altered oxygen consumption during hyperketonemia in healthy subjects.~   "
92413|NCT02357537|"~     This study is designed to assess differences in remote and on-site patient study~     participation in the State of Massachusetts, as well as the significance of dietary~     interventions and their impact on UC. The study will activate one site with a Principal~     Investigator who will utilize each subject's local care system (local Gastroenterologist) to~     collect study data, along with telemonitoring and video visits, to make key study assessments~     and decisions regarding subjects' progression in the study.~   "
92414|NCT02357524|"~     The study will determine the magnitude and duration (time to resolution i.e., returning to~     normal ranges) of elevations in the following coagulation test results after a single 1200 mg~     dose of oritavancin: Prothrombin Time/International Normalized Ratio (PT/INR), Activated~     clotting time (ACT), Activated Partial Thromboplastin Time (APTT), Chromogenic Factor Xa~     Assay, D-dimer, Silica Clot Time and Dilute Russell's Viper Venom Time (DRVVT).~   "
92415|NCT02357511|"~     The study aims to define the sensitivity and specificity of a novel continuous noninvasive~     blood pressure monitor.~   "
92416|NCT02357498|"~     The purpose of this research study is to compare the extent of resection (EOR) in patients~     with nonfunctioning pituitary adenomas undergoing transsphenoidal surgery using a~     microsurgical technique to those patients who have undergone surgery with a fully endoscopic~     technique. Another goal is to compare surgical complications, endocrine outcomes, visual~     outcomes, length of surgery, length of hospital stay, and readmission rates between the two~     transsphenoidal surgery techniques. This is an observational data collection study with no~     experimental procedures or experimental medicines. Endonasal transsphenoidal removal of a~     pituitary tumor is a unique procedure and there is little information comparing the two~     surgical techniques.~   "
92417|NCT02357485|"~     This safety and feasibility study used autologous adipose-derived stromal cells (ADSC), the~     stromal vascular fraction (SVF), to treat 8 osteoarthritic (OA) knees in 6 patients of grade~     I to III (K-L scale) with initial pain of 4 or greater on a 10 point scale, under~     Institutional Review Board (IRB) approved protocol.~   "
92418|NCT02357472|"~     The supplementation of Dehydroepiandrosterone (DHEA) has been used in some centers for~     patients with previous poor ovarian reserve and response in an attempt to improve pregnancy~     outcomes. However, there still has controversy on the clinical effect on the 75mg/d for the~     use,especially in Asian people. Whether the double dosage of DHEA in patients with poor~     ovarian reserve and response in China can improve the IVF outcome with little side effect is~     unknown.~      The aim of this randomized controlled study is to compare the effect of a higher dose (150mg~     daily) and a standard dose (75mg daily) of DHEA on the number of oocytes obtained in poor~     ovarian responders. The effect of DHEA action on the cumulus cells will be examined.~   "
92419|NCT02357459|"~     The purpose of this study was to assess the safety and efficacy of FX006 for the treatment of~     pain in patients with osteoarthritis of the knee.~   "
92420|NCT02357433|"~     The study objective is to clarify whether the application of high doses CPFA (Coupled~     Plasma-Filtration Adsorption) in addition to the current clinical practice is able to reduce~     hospital mortality in septic shock patients in intensive care unit (ICU).~   "
92421|NCT02357420|"~     The purpose of this study is to evaluate the effects of multiple dose regimens of RM-131 on~     vomiting episodes, gastric emptying and gastroparesis symptoms in patients with Type 1 and~     Type 2 diabetes mellitus and gastroparesis. Study drug (RM-131 and placebo) will be~     administered subcutaneously in a blinded fashion.~   "
92506|NCT02356302|"~     Research is currently underway to develop new HIV prevention strategies. Intravaginal rings~     (IVRs) are one drug delivery method that is currently being studied. This study will evaluate~     the safety and pharmacokinetics of IVRs containing vicriviroc, MK-2048, and a combination of~     vicriviroc/MK-2048, in healthy, HIV-uninfected women.~   "
92422|NCT02357407|"~     Fluoroquinolones (FQ) are among pivotal antibiotic treatments in difficult-to-treat~     infections. Their efficacy has been shown to be linked to the ratio area under the curve~     (AUC) of their plasma concentrations over the minimum inhibitory concentration (MIC) of the~     bacteria treated. Eventually, Forrest et al., reported in gram-negative infections that an~     AUC/MIC above 125 conducted to a 80 to 90% clinical success whereas success decrease to 30 to~     40% in patients with an AUC/MIC below this threshold. These results have been reproduced~     recently by Zelenitsky et al. in intensive care unit (ICU) patients with threshold similar to~     the one obtained by Forrest et al. Lastly, elevated concentrations of FQ should be related~     with the onset of adverse events. Thus, therapeutic drug monitoring (TDM) of FQ appears of~     potential interest, particularly in case of severe infections (intensive care unit (ICU)~     patients) or complicated and cost-related infections (osteoarticular infected (OAI)~     patients), with an increasing level of evidence of its use.~      However, FQ TDM requires access to the full AUC of the drug with the need of many samples~     drawn to patients. This appears to be irreconcilable with clinical practice but can be~     achieved using population pharmacokinetic (PkPop) modelling. PkPop allows estimating~     pharmacokinetic parameters of the drug by introducing covariates (demographic, biological,~     clinical…) and modelling inter-individual pharmacokinetic variability. The model created~     allows then accessing to individual parameters of patients and thus, estimating~     concentrations and AUC of the FQ. This approach may also be used in clinical practice to~     determine a limited sampling strategy allowing an adequate estimation of AUC with a minimum~     of samples.~   "
92423|NCT02357381|"~     A multi-center, prospective, non-randomized, single arm, open label, post-market,~     observational study to evaluate the use of the eneura, springtms system in reduction of~     migraine headache symptoms.~   "
92424|NCT02357368|"~     This is a prospective cohort study focusing on HIV negative women. The investigators want to~     learn how the following types of contraceptive methods: Depot medroxyprogesterone acetate~     (DMPA), Etonogestrel impant (Eng-Implant), Levonorgestrel intrauterine device (Lng-IUD) and~     the ParaGard® T 380A Intrauterine Copper Contraceptive impacts the vaginal immune~     environment.~   "
92425|NCT02357355|"~     Charcot Marie Tooth 1A (CMT 1A) is a common inherited disorder of the nerves in the body. The~     disease can result in difficulties with strength and balance as well as in foot deformities~     such as high arches, hammer toes, and tight ankles. Because of these difficulties, the~     disease may affect driving, especially because driving requires quick responses at times such~     as slamming on the brakes or turning the steering wheel quickly. The following study~     determines driving performance in individuals who have CMT 1A.~   "
92426|NCT02357342|"~     Phase 2 clinical trial, single site, randomized, subject-masked study to determine safety and~     efficacy of intravitreal injections of Sirolimus in subjects with wet Age-Related Macular~     Degeneration (wet AMD) with persistent intraretinal or subretinal edema due to neovascular~     AMD despite previous AntiVEGF treatment.~   "
92427|NCT02357329|"~     This study will investigate fat taste and if free fatty acids (FFA) in food function as a~     signal for fat content. FFA are quite unpleasant - the investigators want to measure if the~     concentration in different foods correlates with hedonic preference. FFA concentration from a~     variety of foods will be used to determine if people who have greater sensitivity for FFA~     find foods with higher FFA concentrations less acceptable. Further, this study with determine~     whether the relationship between fat taste and hedonic food preference is modified by sex and~     body mass index (BMI).~   "
92428|NCT02357316|"~     The investigators seek to determine how genetics and the environment influence the ability to~     taste and smell fat. The investigators believe that people who consume higher fat diets and~     people who have higher body fat levels are less able to taste and smell fat. The~     investigators expect to see that people who are less able to taste and smell fat will share~     certain genetic differences.~   "
92429|NCT02357303|"~     The upper endoscopy is one of the most common methods for the diagnosis and treatment of~     upper gastrointestinal (GI) tract diseases and provides a unique opportunity to identify~     early neoplastic lesions.~      Before an upper endoscopy it is required a 6 hour fasting period[1]. However, even with this~     fasting period, sometimes the mucosal visualization, especially in the stomach, is impaired~     by the presence of foam, bubbles or gastric mucus.~      To improve visualization of the gastric mucosa, it is possible to administrate an oral~     solution of defoaming agents such as Simethicone and mucolytic agents like Pronase or~     N-Acetylcysteine previously to the procedure.~      The aim of this project is to determine if the use of premedication with simethicone, alone~     or in association with N-Acetylcysteine, improves mucosal visualization during an upper GI~     endoscopy.~   "
92430|NCT02357290|"~     Children between the ages of 5-17 years old who have or display symptoms of emotional~     dysregulation (explosiveness, mood swings, irritability, and/or violent behavior) are invited~     to participate in a 12-week research study to determine the effectiveness and safety of the~     natural treatment N-acetylcysteine (NAC) for children with emotional and behavioral problems.~     After undergoing a comprehensive evaluation by medical doctors with a specialty in this area,~     children who are found eligible to participate in this research study will be treated with~     NAC. Following the evaluation period, this research study requires 12 weekly visits, either~     in our office or over the phone, in an effort to closely monitor each child's response to the~     medication. Eligible participants will receive study-related evaluations and weekly study~     visits with our study doctors at no cost.~   "
92440|NCT02357160|"~     The Value of Integrating Visual Arts (VIVA): Evaluating the Benefits of Hospital Room Artwork~     on Inpatient Wellbeing will use a large randomized controlled trial design to investigate how~     the inclusion of visual arts in the hospital rooms of cancer patients benefits their~     quality-of-life during treatment. This 18-month research study will provide hospitals with~     evidence of the therapeutic value of the visual arts as measured by patients' perceptions of~     anxiety, pain ratings, use of pain medications, need for nurses, and length of stay. Data~     also will be collected on patients' evaluation of hospital rooms, specifically on décor~     including artwork, so as to correlate patient wellbeing with the presence of artwork.~     Ultimately, this project aims to increase support of and appreciation for the arts from a~     major consumer—namely, healthcare providers—by justifying the value of integrating local~     visual art into inpatient rooms and providing patients with aesthetic choice during their~     stay.~   "
92431|NCT02357277|"~     There are over 10 million individuals with asthma using inhaled glucocorticoids (IGCs) in the~     United States. While oral GCs are recognized to have destructive skeletal effects, far less~     is known about the effects of IGCs. This gap in our knowledge is of critical importance, not~     only because of the prevalence, chronic nature and long duration of IGC use, but also because~     several studies have found that patients using IGCs are at increased risk of fracture.~     Fracture risk is greatest in postmenopausal (PM) women, in whom IGCs may augment negative~     effects of estrogen loss and aging.~      The investigators hypothesize that initiation of IGCs in IGC naïve PM women will lead to~     decreased bone formation and uncoupling of bone turnover, a potential mechanism for the~     effect of IGCs on the skeleton.~      To test our hypothesis, the investigators will perform a randomized, controlled 4 week study~     of the acute effects of commonly used doses of budesonide (360 or 720 mcg) on bone turnover~     and circulating osteoblast precursors in 60 treatment naïve, non-asthmatic, PM women. These~     studies are of high clinical significance because there are currently no guidelines regarding~     screening, prevention or treatment for osteoporosis in patients using IGCs, nor is IGC use~     taken into account when calculating fracture risk in PM women, the group at highest risk of~     fracture. High quality evidence for low volumetric bone mineral density (BMD) and abnormal~     bone quality in PM women using IGCs has the potential to change clinical practice by~     supporting specific interventions to prevent bone loss and fractures.~   "
92432|NCT02357264|"~     This project will study the use of ultrasound of the chest for the detection of fluid in the~     lungs in patients with pre-eclampsia vs pregnant patients without pre-eclampsia.~     Pre-eclampsia is a syndrome usually diagnosed in the second half of pregnancy in which~     patients develop elevated blood pressure and may develop protein in their urine, neurologic~     abnormalities, fluid in the lungs, and abnormal blood tests associated with the liver and~     kidney. Pulmonary edema (fluid in the lungs) in pre-eclampsia can lead to patient discomfort~     and significant morbidity and mortality. It can be detected using chest x-ray, although this~     type of imaging offers significant disadvantages, including radiation, which is of particular~     concern in pregnant patients. In addition, previous studies have demonstrated that chest~     x-ray is not very accurate in the detection of fluid in the lungs. Multiple previous studies~     have demonstrated the utility of chest ultrasonography in detecting fluid in the chest,~     although the vast majority of these studies involved patients with acute decompensated heart~     failure. Our goal is to evaluate bedside ultrasound of the chest in patients with~     pre-eclampsia in comparison to normal pregnant patients to determine whether these patients~     have abnormal fluid in the chest.~      The investigators will divide our patients into two groups. In the study group, the~     investigators will include patients with pre-eclampsia with or without shortness of breath,~     and in the control group, the investigators will include pregnant patients without~     pre-eclampsia. Informed consent will be obtained from all patients enrolled in the study.~     These patients will then undergo an ultrasound of the chest, performed by a member of the~     Emergency Medicine Ultrasound Division. The images will be transmitted wirelessly from the~     ultrasound machine to a secure web based cloud (Q-path) and will be subsequently reviewed by~     expert reviewers.~   "
92433|NCT02357251|"~     This is a single-blinded randomized control trial comparing the current perioperative care of~     the investigators gynecologic oncology patients with a standardized perioperative enhanced~     recovery pathway. Adult patients undergoing laparotomy by one of the gynecologic oncology~     surgeons will be eligible to participate. The primary outcome will be length of~     hospitalization including any days of readmission in the 30 days post-operatively. Secondary~     outcomes will include 30-day readmission rate, complications, quality of recovery, and pain~     control.~   "
92434|NCT02357238|"~     In order to improve the investigators knowledge about uveitis and the underlying mechanism of~     disease, the investigators propose collecting blood from patients with uveitis, isolating DNA~     and sequencing the DNA to identify genetic mutations or associations in these patients.~   "
92435|NCT02357225|"~     Pyridostigmine is an acetylcholinesterase inhibitor, which degrades acetylcholine at the~     neuromuscular junction. Based on recent studies, pyridostigmine may be an effective adjuvant~     treatment for people with Pompe disease, as it increases the functional impact of this~     neurotransmitter.~      Hypothesis: the use of pyridostigmine in Pompe disease will improve transmission of~     acetylcholine across the neuromuscular junction, skeletal muscle function, respiratory~     function, and quality of life.~   "
92436|NCT02357212|"~     The aim of this research is to evaluate the effect of early invasive therapy and appropriate~     revascularization compared with conservative management and selective revascularization among~     women with an acute coronary syndrome.~   "
92437|NCT02357199|"~     This study aims to investigate the prevalence of oral infection in chronic renal disease~     patients and to examine whether a focused oral hygiene intervention can reduce oral infection~     leading to reduced systemic inflammatory parameters in chronic renal disease patients in~     hemodialysis, chronic renal disease patients waiting for kidney transplantation, and chronic~     renal disease patients who has been transplanted 1-1½ year previously. The results will be~     compared to a gender- and age-matched healthy control group.~   "
92438|NCT02357186|"~     Head injury is a frequent reason for consultation with pediatric emergencies, over 95% are~     mild head injury defined by a Glasgow score greater than or equal to 13. In October 2009, the~     Pediatric Emergency Care Applied Research Network has published a rule clinical decision~     support of mild head injury of the child with the aim to identify children at very low risk~     for clinically severe intracranial lesions in order to avoid the use of CT and unnecessary~     exposure to radiation ionizing. This clinical decision rule constructed from a multicenter~     prospective cohort 42,412 American children allows on anamnestic and clinical elements to~     guide medical decision for conducting brain imaging, hospital monitoring or discharge home~     placing the child in three levels of risk of clinically severe intracranial lesions.~      Since March 2012, the French Emergency Medicine Society recommends for the treatment of mild~     head trauma the child's use of the clinical decision rule provided that it is the subject of~     a validation study externally. Indeed, after the construction phase and before its daily~     application, a clinical decision rule must be subject to an broad validation process so that~     its predictive performance can be definitively established.~      The investigators' work aims to conduct this broad validation study prospective multicenter~     way in a French pediatric population, as recommended by the French Emergency Medicine~     Society, in order to confirm or deny its predictive performance and allow its application and~     generalization. The investigators will check and if the Rule Clinical Decision is adapted or~     not to the management of mild head injuries in the French pediatric population.~   "
92439|NCT02357173|"~     The purpose of this study is to examine cigarette smokers' use of electronic cigarettes~     (e-cigarettes), and how use of e-cigarettes affects short term smoking behavior.~   "
92465|NCT02356835|"~     This is a 10-week, randomized, controlled study to evaluate the efficacy and safety of the~     APT001 plasma and nitric oxide treatment in subjects with a diabetic foot ulcer.~   "
92441|NCT02357147|"~     This study was originally designed as a multicenter, double-blind, randomized, parallel-group~     study, using a placebo control or amatuximab 5 milligrams per kilogram (mg/kg), administered~     weekly, designed to evaluate the safety and efficacy of amatuximab in combination with~     pemetrexed and cisplatin in participants with unresectable Malignant Pleural Mesothelioma~     (MPM) who have not received prior systemic therapy.~      Per a business decision made by the Sponsor, participants who were randomized to amatuximab~     and are still on active treatment at the time of the protocol amendment may consent to~     continue to receive weekly treatment with amatuximab until disease progression or intolerable~     toxicity at the discretion of the principal investigator. Participants randomized to placebo~     or who were in follow-up at the time of the amendment have been discontinued from the study.~   "
92442|NCT02357134|"~     The goal of this clinical research study is to learn if high-flow oxygen, low-flow oxygen,~     high-flow air, or low-flow air, when given during structured exercise sessions, can help~     reduce difficulty breathing in cancer patients. Researchers also want to learn if these~     therapies can help to improve lung function and quality of life.~   "
92443|NCT02357121|"~     This is an open-label pilot, feasibility/exploratory study to evaluate the safety of laser~     interstitial thermal therapy (LITT) using Visualase in the focal ablation of prostate tissue~     and to gather data for the design of future studies. Intra-procedure temperature and~     concurrent rectal wall thermistor monitoring will be performed for internal validation.~     Subjects will be monitored for adverse events, and health-related quality of life (HRQOL)~     questionnaires will be obtained. Post-treatment MRI and biopsies will be obtained to evaluate~     histologic and radiologic changes. Biomarker (PSA, PCA3 and PHI) kinetics will also be~     monitored.~   "
92444|NCT02357108|"~     The goal of this study is to learn what types of conversations patients prefer to have with~     their doctor about treatment options and how patients view their doctor's compassion.~   "
92445|NCT02357095|"~     The purpose of this study is to determine whether UACE(uterine artery chemo-embolization)~     followed by suction curettage under the guidance of ultrasonography or hysteroscopy can~     decrease complications in the treatment of Caesarean scar pregnancy (CSP).~      CSP is a special form of ectopic implantation within a fibrous tissue surrounding the~     previous delivery caesarean scar. The probability of CSP is 1:1800 to 1:2,226 in all~     pregnancies, and 6.1% in ectopic pregnancy after cesarean delivery. It's a long-term~     complication after cesarean delivery with very serious consequences,such as uterine rupture~     and massive uterine bleeding.There are more than ten methods to treat CSP,however, no~     universal management guidelines have been established up to now.~      Present methods for CSP treatment include:1)medical treatment,usually systemic or local~     methotrexate（MTX）;2）suction curettage;3)medicine combined with uterine curettage;3）surgical~     treatment（hysteroscopic,laparoscopic or vaginal surgery）;4) uterine artery~     embolization(UAE);5) The combined use of the above methods.~      Moreover, the rupture of the CSP and heavy bleeding may still occur following medical~     treatment.Suction curettage and excision of the CSP are associated with profuse bleeding.~     Surgical treatment is less micro-traumatic than nonsurgical interventions. For CSP, UAE~     followed by suction curettage appears to have more advantage than systemic MTX treatment and~     may be a priority option.So some author suggests that curettage and systemic methotrexate~     therapy and embolization as single treatments should be avoided if possible,combination of~     them is more effective. Plenty of evidences suggested that UACE followed by suction curettage~     under the guidance of ultrasonography or hysteroscopy is a priority choice.~      However,in our clinical practices,suction curettage of CSP is more difficult than usual~     induced abortion procedure of normal early pregnancy,because PCSD(previous cesarean scar~     defect)is very common in CSP.In random populations the incidence of PCSD is present in~     24%-69% of women evaluated with transvaginal sonography. Scar defects were seen in 61%~     (66/108), 81% (35/43) and 100% (11/11) of the women who had undergone one, two and at least~     three Cesarean sections by the transvaginal ultrasound examination.~      What is the incidence of complications of suction curettage combined with UACE for CSP~     treatment remains unknown.How to decrease the complications remains unknown too.So we~     designed this study.~   "
92446|NCT02357082|"~     Registry intends to prospectively collect data regarding the safety of magnetic resonance~     imaging (MRI) studies in patients with cardiac pacemakers on implantable cardioverter~     defibrillators.~   "
92447|NCT02357069|"~     This is a randomized, double-blind, parallel group, multicenter clinical study to evaluate~     the efficacy, safety, pharmacokinetics and immunogenicity of LBEC0101 compared to Enbrel in~     subjects with active Rheumatoid Arthritis despite Methotrexate therapy.~   "
92448|NCT02357056|"~     The purpose of this research is to objectively compare various training modalities currently~     available in minimally invasive and robotic surgery to determine the most effective training~     methods specific to robotic cardiac surgery. We hope to recruit medical trainees with minimal~     robotic surgery training experience, randomly assigned to one of three groups (Dry wab, da~     Vinci Simulator and Wet lab). Trainees will be evaluated at baseline for a standardized tasks~     common in robotic cardiac surgery and then divided into one of the three training modalities.~     Trainees will be given sufficient time to become proficient with a variety of predetermined~     tasks unique to each training group. The trainees will then undergo a reevaluation with the~     cardiac surgery specific tasks at the end of a standard training period. We will then be able~     to compare our three groups to show if any have benefits over the others in regards to~     improvement in technical ability, understanding of the robots functions, efficacy of~     training, speed of technical skill development, accuracy and efficiency of movement. We will~     rate each modality on their reproducibility, accuracy of representation, and ease of set up~     and perform a cost analysis for each of the training methods.~   "
92449|NCT02357043|"~     The study aims to evaluate the accuracy of the blood glucose level results obtained from~     fingertip using the Dario Blood Glucose Monitoring System (BGMS) compared to YSI as well as~     to evaluate the usability of the Dario Blood Glucose Monitoring System (BGMS) by laypersons~     using only device labeling.~   "
92450|NCT02357030|"~     The Gulf War Synergy Trial will evaluate the safety and efficacy of a currently available~     medication, methylphenidate (Ritalin®), combined with a GWI Nutrient Formula (K-PAX Synergy)~     to treat Gulf War Illness (GWI).~   "
92451|NCT02357017|"~     The purpose of the study is to test the hypothesis that persistent fluid retention and high~     sympathetic output contributes to the development of refractory hypertension (HTN). The~     investigators will determine, in a cross-over assessment of high and low salt diets, if~     dietary sodium restriction reduces 24-hr ambulatory BP in patients with refractory HTN.~     Moreover, the investigators will determine if dietary sodium restriction lessens the severity~     of obstructive sleep apnea (OSA) in patients with refractory HTN.~   "
92452|NCT02357004|"~     The purpose of this protocol is test whether patients with hypertension refractory to~     antihypertensive treatment have evidence of excessive sympathetic (i.e., nervous system)~     activity.~   "
92453|NCT02356991|"~     Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and~     Flt3. Phase I study has shown that the toxicity is manageable.~      The purpose of this study is to evaluate the efficacy and safety profile of Famitinib in~     patients with Advanced Non-squamous and Non-Small Cell Lung Cancer (NSCLC).~   "
92454|NCT02356978|"~     Evaluating the efficacity of a new device phototherapy by comparing it with conventional~     phototherapy. Jaundice occurs in many newborns, and is, in most cases benign, However, owing~     to the potential neurotoxicity of unconjugated bilirubin, newborns must be monitored to~     identify those who might develop severe hyperbilirubinemia an, in rare cases, acute bilirubin~     encephalopathy or kernicterus. Treatment of jaundice in newborn relies on phototherapy,~     exposing their skin to light of a specific wavelength . Fluorescent tubes or halogen lamps~     have been used as light sources for phototherapy for many years. Light-emitting diodes (LEDs)~     are more recent sources which are power efficient, have a longer life and are portable with~     low heat production. Several technologies and devices are developed using LEDs and specially~     a compact system.~   "
92455|NCT02356965|"~     The purpose of the study is to test two different doses of ketamine sub-lingual (under the~     tongue) wafer against placebo to see how effective the medication is to treat moderate to~     severe pain after wisdom tooth extraction.~   "
92456|NCT02356952|"~     Metabolic Syndrome (MetS) is a cluster of multiple risk factors of metabolic origin~     associated with an increased risk of cardiovascular disease, type 2 diabetes mellitus and~     other diseases, including some cancers. There has been an increased interest of researchers~     in the relationship between MetS and diet and, specifically, Mediterranean diet would be~     beneficial for people with high risk of developing MetS or individuals with established MetS.~   "
92457|NCT02356939|"~     Randomized controlled trial including 7 French transplantation centers. Pre-inclusion of the~     patients is made when enlisted for LT. Definitive inclusion and randomization is performed~     during LT, for patients undergoing a duct-to-duct biliary anastomosis with a graft bile duct~     diameter smaller than 7mm. In the intraductal stent tube group, a custom-made segment of a~     T-tube is placed into the bile duct, and removed endoscopically four to six months~     postoperative. The surgical technique is available on a movie during randomization on the~     website. The primary endpoint is the occurrence of biliary complications, including biliary~     fistulae and strictures, during six months of follow-up. Secondary evaluation criteria are~     the incidence of complications related to the stent placement and its extraction by~     endoscopy.~      Discussion: Biliary complications following LT are significant causes of morbidity,~     retransplantation and eventually mortality. Although controversial, the use of a T-tube has~     been proven to be useless and even responsible for specific complications in many studies,~     including several randomized trials. However, several studies have identified a small bile~     duct diameter as a risk factor for biliary stenosis. A threshold of 7mm was found to be~     significantly associated to biliary stenosis. Our team published a preliminary study~     including 20 patients using a new technique of intraductal stenting. Only 4 complications~     were reported in the overall study population while no biliary complication occurred in the~     subgroup of patients who received a whole graft LT. Moreover, no technical failure and no~     procedure-related complications were noted before and during drain removal. Although~     intraductal stent tube in duct-to duct biliary anastomosis seems feasible and safe, a~     multicentric randomized controlled study is needed to validate it as a protective tool for~     biliary complications following LT.~   "
92458|NCT02356926|"~     Multicenter cluster randomized study to evaluate the reduction of the rate of severe medical~     errors with implementation of systematic cross checkings between emergency physician.~   "
92459|NCT02356913|"~     The purpose of the study is to compare the pharmacokinetic (PK) profiles and assess~     bioequivalence between three new nicotine gum formulations and a reference nicotine gum in~     healthy smokers.~   "
92460|NCT02356900|"~     This study seeks to examine the effectiveness of training while in a hyperoxic-hyperbaric~     environment for exercise performance at altitude. Subjects will complete a short,~     high-intensity interval training (HIT) program inside the hyperbaric chamber.Before and after~     this training phase, all subjects will be tested for maximum aerobic capacity at a simulated~     high altitude of 15,000ft in a hypobaric chamber, as well as for molecular markers of~     mitochondrial oxidative capacity in a skeletal muscle biopsy.~      A group of individuals of similar characteristics completing this training program in a~     normoxic-normobaric environment will serve as a control.~   "
92461|NCT02356887|"~     During neurosurgical procedures, patients need to be placed in sitting position for surgical~     access especially in surgeries in the vertex or posterior fossa. Due gravitational effect of~     sitting position the flow in IJV may be reduced. Venous air embolism (VAE) is a common~     complication of sitting position craniotomy and carries high mortality and morbidity. Venous~     pressure decreases as the head of the patient is raised above the heart. Hence, negative~     venous pressure in the cerebral venous system promotes entrapment of air in accidental~     opening of the sinuses.~      Common methods to prevent VAE in sitting position include increasing the venous pressure by~     either jugular venous compression and/or increasing the venous pressure by adding positive~     end expiratory pressure (PEEP). Both these methods can decrease venous return and can lead to~     brain swelling.. In addition, improper neck position can cause the kinking of the IJV which~     may lead to decreased venous drainage and increased ICP. This has been shown to be the~     contributing factor for intraoperative brain swelling and postoperative neck and tongue~     swelling leading to airway obstruction. Optimal brain perfusion is best in the neutral~     position of the head, but surgery cannot always be performed with this.~      Currently, there are no studies that looked into the IJV flow in sitting position and effect~     of venous outflow obstruction on the IJV flow. Valsalva maneuver (forced inspiration with~     closed glottis) and /or compression of internal jugular veins (IJV) are the two commonly used~     physiological methods that can cause venous outflow obstruction. A custom made neck collar~     can be used for compression of internal jugular vein and previous investigations have used a~     similar device in a rat model to demonstrate the protective effects on slosh-mediated brain~     injury by increasing intracranial blood volume . While the collars have not yet been studied~     on people for their effectiveness at preventing concussions, many studies have looked at the~     effect of neck collars on both jugular compression and ICP..~      The purpose of this study is to measure the venous blood flow of healthy volunteers by the~     use of an ultrasound and Doppler velocimetry in sitting position. the investigators will~     measure the IJV flow on both sides in sitting position at rest and at two conditions of~     venous outflow obstruction- 1. Neck compression using a custom made collar and 2. During 30~     seconds Valsalva maneuver. This study will provide information on the cerebral venous~     drainage. This information will be very useful in planning and positioning of patients~     undergoing neurosurgical procedures and to prevent complications from the improper patient~     position.~   "
92462|NCT02356874|"~     The overall aim of this multicenter randomised controlled trial (RCT) is to investigate if~     exercise can modify the disease course and prevent comorbidity in patient with~     spondyloarthritis (SpA).~   "
92463|NCT02356861|"~     The purpose of this study is to learn if an experimental treatment can help thinking ability,~     and memory in Veterans with mild or moderate traumatic brain injury (mTBI), and~     post-traumatic stress disorder (PTSD). The experimental treatment is called transcranial,~     light-emitting diode (LEDs) therapy,and uses groups of LEDs mounted inside a helmet. The~     helmet is worn on the head, and the LEDs shine painless light on the sides, middle and front~     of the head through the scalp. The participants receive a series of LED treatments which take~     place as outpatient visits at the VA Boston Healthcare System, Jamaica Plain Campus. The LEDs~     contain near-infrared diodes. The FDA considers the LED device used here, to be a~     non-significant risk device. The LEDs do not produce heat.~   "
92464|NCT02356848|"~     This study will evaluate a comprehensive tailored behavioral intervention aimed to improve~     foot self-care and self-monitoring (combined with dermal thermometry) to prevent recurrent~     ulcers in Veterans at highest risk of amputation. This intervention may be a novel strategy~     for improving self-care and early detection of foot abnormalities in this at-risk population~     using psychological theories to target multiple health behaviors simultaneously. This could~     be an efficient and cost-effective approach to improve diabetes-related foot health behavior,~     and other risk factors in patients who are vulnerable to devastating consequences related to~     amputation.~   "
92466|NCT02356822|"~     This is an investigational multi-site outcomes registry intended to collect information about~     a patient's cancer care. Patients may enter the Registry at any time during the patient's~     current stage in the continuum of care. The registries main objectives will be to measure and~     evaluate the effects of patient care throughout the care continuum, resulting in the~     identification of the most effective treatment options. Objectives will encompass evaluations~     and analytics around safety, effectiveness, and improved efficiencies.~   "
92467|NCT02356809|"~     The purpose of this study is to determine whether pl-vegf165 (Neovasculgen) is effective in~     the treatment of digital ulcers related to secondary Raynaud's phenomenon associated with~     systemic scleroderma~   "
92468|NCT02356796|"~     The purpose of this study is to evaluate the effect of a multidisciplinary group based~     treatment compared to standard physiotherapy for women with chronic pelvic pain (CPP). The~     hypothesis is that multidisciplinary group based treatment is more effective than standard~     physiotherapy for women with CPP. The participants will be randomized to one of two treatment~     arms, and the treatment effect will be evaluated 12 months after start of intervention.~   "
92469|NCT02356783|"~     Our aim is to assess usability and compliance of a wireless pedometer for monitoring step~     count after a lumbar epidural steroid injection for the treatment of radicular pain in low~     back pain patients. Our main hypothesis is to demonstrate pedometer measured step count can~     be used to measure efficacy of pain interventions.~   "
92470|NCT02356770|"~     The objective of this study is to investigate the safety and the function of the collagen~     Matrix 10808 in humans and to compare it versus the standard therapy, the transplantation of~     the autologous connective tissue graft. The Collagen Matrix was developed for soft tissue~     augmentation. It is a three dimensional porous Matrix and consists mainly of Collagen I and~     III.~      Study patients must have a single tooth gap with insufficient soft tissue volume after~     implant placement. Therefore a soft tissue augmentation will be necessary.~   "
92471|NCT02356757|"~     The PATRIOT study will evaluate a risk-based personalized behavioral intervention to improve~     foot self-care, self-monitoring, and modifiable risks for amputation such as blood glucose,~     blood pressure and cholesterol in order to prevent diabetic foot ulcers in patients at higher~     than normal risk for amputation. This novel intervention aims to improve self-care and early~     detection of foot abnormalities in at-risk patients with diabetes and poor foot self-care~     using advanced behavioral approaches to target adherence to multiple health behaviors,~     including foot self-care, self-monitoring, medication adherence, dietary adherence, and~     physical activity simultaneously. If this promising behavioral theory-driven approach~     delivered using common technology (phone) to the patient at home can work in a setting where~     improvements in foot care are so urgent, it will be an important scientific contribution.~   "
92472|NCT02356744|"~     Ultrasound follow up for 9 months pregnancy in women underwent baraitric surgery before and~     after 1 year of surgery.~   "
92473|NCT02356731|"~     Epilepsy is one of the most common neurological diseases.Approximately 53 million people~     suffering from chronic recurrent epilepsy in 1990 and that number increased about 58 million~     in 2005.~      The annual incidence of epilepsy varies considerably in different epidemiological studies,~     ranging from 11 cases per 100,000 general population to 230 cases per 100,000 people.~      To date there has been discovered the ideal Antiepileptic Drugs. The drug, ie, that are safe~     and effective, it has good daily administration frequency, easily administered from all~     roads, which has high bioavailability, which is not highly bound to proteins, and not holding~     inductive or inhibitory effect.~   "
92474|NCT02356718|"~     This study examines whether computer tasks can improve memory and other cognitive functions~     among patients receiving inpatient treatment for substance use disorders.~   "
92475|NCT02356705|"~     Midazolam is often given before surgery to sedate a patient before anesthesia is given.~     Children are often given a small dose either by mouth or squirted into the nose. Children~     will often spit out the oral midazolam, making it difficult to know how much medicine, if~     any, they have received. Giving midazolam into the nose is more reliable, but children may~     complain of pain, stinging, and may become upset due to the discomfort. Nosebleeds may also~     occur when midazolam is squirted alone into the nose. The purpose of this study is to see if~     adding a numbing medicine, xylocaine, to the nasal midazolam makes giving the midazolam~     easier and more comfortable without affecting how the midazolam works as a sedative. This is~     follow up to the pilot study, Project # 994. This will expand the previous study, with~     additional participants and revised xylocaine concentration~   "
92476|NCT02356692|"~     The purpose of this study was to investigate the overall clinical comfort performance of~     enfilcon A and senofilcon A lenses over 15-minutes of lens wear.~   "
92477|NCT02356679|"~     The purpose of this study is evaluate the Efficacy and Safety of EUPASIDIN-S Tab. in~     Gastritis Patients.~   "
92478|NCT02356666|"~     Different definitions of nocturnal hypoventilation are used in the recent literature. The~     investigators aimed to compare the prevalence of nocturnal hypoventilation in a neuromuscular~     disease's population according to different definitions issued from the literature.~   "
92479|NCT02356653|"~     The goal of this protocol is to expand access for patients who lack a fully HLA (Human~     leukocyte antigen) matched sibling donor and who are candidates for allogeneic hematopoietic~     stem cell transplant (HSCT). These patients have a serious or immediately life-threatening~     disease for which HSCT is indicated. These patients are not eligible for other Children's~     Hospital of Philadelphia IRB approved protocols that utilize CliniMACs technology for T~     depletion.~   "
92490|NCT02356510|"~     The current guidelines still recommend emergent PCI of the culprit lesion and state that~     primary PCI should be limited to the culprit vessel with the exception of cardiogenic shock~     and persistent ischaemia after PCI of the supposed culprit lesion. This recommendation is~     based on a high number of studies. However, several studies are present about the safety and~     efficacy of non-culprit vessel PCI during acute MI. Nowadays, the debate is increasingly~     going on about the PCI of the non-culprit arteries during the index event with newer~     prospective randomized studies. Besides, it is still unclear for the culprit artery whether~     to treat only the culprit lesion or all the other lesions in the culprit vessel during the~     index event. The present report describes a retrospective comparison between the two~     strategies during primary PCI for STEMI, looking for their influence on the clinical and~     angiographic course of the patients.~   "
92480|NCT02356640|"~     Patients suffering from pancreatic cancer are associated with a poor prognosis and survival~     of less than one year is expected in inoperable tumours. Management of these patients would~     be towards palliation of symptoms. Severe pain occurs in 50 to 70% of the patients and this~     intractable pain is often difficult to treat. Different pharmacological agents have been~     used in the past to control this pain and these include non-steroidal anti-inflammatory drugs~     and narcotic agents. However, patients' responses are often variable and difficult to~     predict. Furthermore, these agents are associated with their own adverse effects and may~     further impair quality of life.~      Celiac plexus neurolysis (CPN) was first described in 1919, since then, different approaches~     of performing the procedure have been described. The standard technique involves a~     percutaneous approach but CPN can also be performed by an intra-operative approach with open~     or laparoscopic means. Results from meta-analysis have shown that CPN was associated with~     superior pain relief as compared to analgesic therapy alone and reduces the need for opioids~     analgesics in patients with inoperable pancreatic cancer. Furthermore, CPN causes fewer~     adverse effects than opioid analgesics and it is the preferred method of improving pain~     relief in these patients.~      Recently, endoscopic ultrasonography (EUS) - guided CPN has become popular. The approach is~     safe and effective and was shown to be associated with long lasting pain relieve in patients~     suffering from chronic pancreatitis or pancreatic cancer. Serious complications are uncommon~     and are less than 2% in these series. Transient diarrhoea and hypotension are common after~     CPN and is seen up to 30% to 40% of the patients, regardless of whether the procedure is~     being done by the EUS or percutaneous approach. The EUS approach offers several theoretical~     advantages over the percutaneous option. Most notably is the visualization of the celiac~     ganglia situated anterior to the aorta, allowing direct injection of the ganglia with alcohol~     resulting in celiac ganglion neurolysis (CGN). This increases the accuracy of CPN and may~     result in improved pain control. Furthermore, it could reduce complications associated with~     the percutaneous approach that includes lower extremity paresthesia and paralysis.~      Hence, the aim of the study is to compare the efficacy and safety of endoscopic ultrasound~     (EUS)-guided celiac ganglion neurolysis (CGN) versus percutaneous celiac plexus neurolysis~     (CPN) in reducing cancer pain in patients suffering from inoperable cancer. With direct~     visualization and injection of the celiac ganglion, the investigators hypothesis that~     EUS-guided CGN is more advantageous on improving pain relief and decreasing the need for~     opioid analgesics in patients with inoperable cancer as compared to percutaneous CPN.~   "
92481|NCT02356627|"~     The purpose of this study is to examine the effectiveness and cost-effectiveness of the~     Cancer Home Life Intervention compared to usual care on performance of and participation in~     everyday activities and quality of life in people with advanced cancer living at home.~   "
92482|NCT02356614|"~     This is a post-approval, multicenter, prospective, non-randomized, open-label, clinical study~     to evaluate the safety and effectiveness of the LAP-BAND® AP System in a lower obese~     population (BMI ≥ 30 kg/m2 and < 40 kg/m2) with one or more obesity-related comorbidity up to~     10 years after implantation.~   "
92483|NCT02356601|"~     Ultrasound is used increasingly to aid placement of neuraxial blocks. Good visibility of~     ligamentum duramater complex and posterior longitudinal ligament (LF, PLL) has a positive~     predictive value of 85% for successful neuraxial block. Dural puncture could still be~     feasible despite the absence of a good view, as reflected by a negative predictive value of~     30%.~      Poor neuraxial ultrasound view could be due to limitations of ultrasound or various other~     anatomical reasons which might include absent LF, calciﬁcation of ligaments, spinous process~     contact and presence or absence of epidural or subdural fat. This will be the first study of~     its kind to compare neuraxial ultrasound with MRI. The aim of this study is to look for~     anatomical correlation between neuraxial ultrasound and MRI at various lumbar interspinous~     levels and to look at factors that contribute to abnormal neuraxial imaging. Assuming the~     predicted abnormal ultrasound images to be around 30% and predicted abnormal MRI images to be~     5%, 79 images should give a power of 0.9 and alpha 0.01 to analyse the association between~     the two. Sample Size Calculations were performed using statistical software R version 2.15.2~   "
92484|NCT02356588|"~     The purpose of this study is to compare the efficacy and safety of the sublingual Sufentanil~     Tablet (ST) 30 mcg to the sublingual Placebo Tablet (PT) for the short-term management of~     moderate-to-severe acute post-operative pain in patients after abdominal surgery.~   "
92485|NCT02356575|"~     The aim of this study is to determine which of two treatments (acupuncture or cognitive~     behavioral therapy) works better for treating insomnia in cancer survivors. The investigator~     also wants to study the factors that might impact why someone might prefer or do better in~     one treatment over the other.~      Group 1 will get Acupuncture - Acupuncture is an ancient Chinese Technique of using very thin~     needles inserted in the skin to treat different symptoms and illness, and to promote healing.~      Group 2 will get Cognitive Behavioral Therapy for Insomnia (CBT-I) - CBT-I is a treatment to~     address behaviors and thoughts that are known to effect problems with sleep.~   "
92486|NCT02356562|"~     The purpose of this study is to evaluate the safety and efficacy of~     ombitasvir/paritaprevir/ritonavir and dasabuvir with or without sofosbuvir (SOF) and~     ribavirin (RBV) in DAA treatment-experienced adults with Genotype 1 Chronic Hepatitis C Virus~     infection. This study will contain 2 parts.~      Part 1: Approximately 20 participants and at least 10 of the 20 participants previously~     treated with the combination of ombitasvir/paritaprevir/ritonavir and dasabuvir, with or~     without RBV, and experienced treatment failure.~      Part 2: Approximately 10 participants and all participants previously treated with~     SOF/ledipasvir and experienced treatment failure.~   "
92487|NCT02356549|"~     The purpose of this study is to determine if the use of tailored health messages and/or~     involving physicians are effective in increasing African American (AA) patient activation in~     a clinical trial consultation. The proposal will use a composite score for patient activation~     derived from the Street Patient Activation Coding system. This will help to determine the~     effectiveness of our intervention on patient activation and patient centered clinical trial~     decision.~   "
92488|NCT02356536|"~     The CuePeD trial is an intervention trial measuring the effectiveness of a novel treatment~     for Freezing of Gait (FOG) in Parkinson's disease (PD). The primary intervention is the use~     of a wearable cueing device (WCD), which detects and responds to FOG and extinguishes on the~     resumption of normal walking. It is designed for use in PD patients with FOG, in their home~     environment where FOG is most severe. Kinematic data will be logged by a memory card in the~     belt worn device recording FOG, and falls. The device will be used on 3 different settings in~     a gait laboratory environment, and then for 2 weeks in the patient's own home using the same~     3 settings. A battery of psychometric instruments will be administered before and after the~     trial~   "
92489|NCT02356523|"~     The Purpose of this study is to evaluate the incidence of delirium in Cardiac Intensive Care~     Unit Patients.~   "
92505|NCT02356315|"~     New advances in medical imaging have allowed for the measurement of brain activity related to~     chronic pain. In addition to the brain, the investigators aim to use functional magnetic~     resonance imaging to investigate pain processing in the brainstem and spinal cord in healthy~     subjects and chronic neck pain patients. The information gained from this study will increase~     the investigators understanding of how chronic pain is encoded in the nervous system and~     assist in developing more effective treatment strategies.~   "
92491|NCT02356497|"~     Bone metastases are frequent distant manifestations of cancer, with pain as a common and~     devastating consequence. The primary treatment for painful bone metastases, external beam~     radiation therapy, is moderately effective: about 60% of patients who undergo conventional~     radiotherapy experience (partial) pain relief. Several factors associated with treatment~     failure have been identified, but no attempts have been made to collapse these factors into a~     clinically useful prediction tool to predict treatment response. In addition, to aid in~     therapy selection based on expected survival time, development of survival models is~     essential. Finally, we need innovative treatments as alternatives or additive to standard~     treatment options to improve quality of life (QoL). For these reasons, we set up the PRESENT~     cohort study, recruiting patients at the departments of radiation oncology and orthopedic~     surgery.~      We aim to provide detailed information about clinical data, create an infrastructure for~     efficient, fast and pragmatic evaluation and implementation of innovative interventions, as~     well as development of accurate new prediction tools.~   "
92492|NCT02356484|"~     The aim of this study is to evaluate the predictive value of albumine, C-reactive protein~     (CRP), procalcitonin, and lactates in terms of surgical stress and postoperative~     complications. These biomarkers will be measured from the day before surgery until~     postoperative day four in patients undergoing major surgery. Major surgery was defined as~     esophagus, gastric, liver, pancreas, endocrine, retroperitoneal, or colorectal procedures~     including an organ resection for benign or malignant disease and lasting more than 2 hours.~   "
92493|NCT02356471|"~     This pilot clinical trial studies how well consumer-based activity monitor works in~     evaluating and measuring activity of older patients with abdominal cancer undergoing surgery.~     Consumer-based activity monitor (CAM) may identify patients who are at-risk for increased~     post-surgery medical problems. With early identification of at-risk patients, CAM provide~     supervised exercise in the preoperative and postoperative periods to improve over mobility~     and potentially decrease preoperative complications among patients undergoing major abdominal~     surgery.~   "
92494|NCT02356458|"~     Mantle cell lymphoma (MCL) remains an incurable disease with frequent relapses and no~     standard therapeutic options in case of relapse. Prolongation of remissions or induction of~     longer remissions is therefore crucial. Recently, a synergistic increase in the proteasomal~     inhibition of ibrutinib in both bortezomib-sensitive and refractory MCL cells was shown.~     These findings, along with the reported single agent activities of both drugs and the~     non-overlapping toxicities, are the rationale to combine ibrutinib and bortezomib in MCL in~     this trial~   "
92495|NCT02356445|"~     Retrospective review of the outcome of use of immunosuppressive drugs in treatment of~     sarcoidosis~   "
92496|NCT02356432|"~     Anticoagulants are generally recognized as a necessary therapy to prevent the recurrence of~     ischemic stroke in patients with non-valvular atrial fibrillation (NVAF), but in some~     patients they also cause bleedings, particularly intracranial hemorrhage. One of the~     independent predictors of intracerebral hemorrhage is the presence of cerebral microbleeds~     (CMBs); a high incidence of intracerebral hemorrhage is reported in patients with multiple~     CMBs. Recent study suggested that patients who had CMBs at baseline developed more new CMBs~     after 2 years (26%), compared with patients (12%) who did not have CMBs at baseline. However,~     there has been no study on the progression of CMBs in patients receiving so-called novel oral~     anticoagulants (NOACs).~      This study tests the hypothesis that the incidence of hemorrhagic stroke is lower in patients~     receiving NOACs (dabigatran, rivaroxaban, apixaban, and edoxaban) than in those receiving~     warfarin, and this difference reflects the difference in the effects of warfarin and NOACs on~     the progression of CMBs. Towards this goal, we enroll 200 patients with at least one CMB~     detected by 1.5 T MRI (T2*WI) at baseline, who treated with NOACs or warfarin for 12 months.~     Primary endpoint is the proportion of subjects with an increased number of CMBs at Month 12~     of treatment with NOACs or warfarin. If the results of this study support the efficacy of~     NOACs in preventing increase of CMBs, this would be of great interest to domestic and~     overseas clinicians, in view of the potential therapeutic impact, including that for primary~     prevention of ischemic stroke.~   "
92497|NCT02356419|"~     The study is a single center and open test, and the dose of successive incremental method was~     taken. In order to determine the tolerance and safety after a single intravenous injection of~     different doses of rESP in healthy subjects, the investigators had this trial. On the other~     hand, this study is to preliminarily explore the pharmacokinetics in healthy subjects.~   "
92498|NCT02356406|"~     This prospective study evaluates celiac plexus radiosurgery for pain control in patients with~     upper abdominal malignancies.~   "
92499|NCT02356393|"~     Association between serum magnesium and clinical outcome in patients with acute MI (AMI) with~     1 year follow-up in 300 patients in regions supplied by desalinated drinking water (DSW)~     (Sheba MC) and 150 patients in regions with non-desalinated drinking water (DW) (Nahariya~     MC).~   "
92500|NCT02356380|"~     To determine the affects of Physical Therapists clinical reasoning using thoracic spine~     mobilization for neck pain compared to a standard protocol.~   "
92501|NCT02356367|"~     The purpose of this study is to determine the predictive factors of poor compliance to sleep~     disordered breathing therapy in chronic heart failure patients treated for central sleep~     apnea. To characterize nocturia pathophysiology associated with SDB in this population. To~     use telemonitoring data to define predictive factors of poor compliance.~   "
92502|NCT02356354|"~     The aim of this study is to understand why the regeneration of the cutaneous sensory nerve~     fibers is poor in post-burn scar.~      The presence or the lack of several molecular factors known to regulate neuronal cell~     development will be evaluate and compared within biopsies from healthy skin and post-burn~     scar.~   "
92503|NCT02356341|"~     This observational study is intended to collect outcome data from a cohort of 90 patients~     suffering from symptoms of dry eye disease due to meibomian gland dysfunction who are treated~     with the medical device NovaTears® eye drops for a duration of 6 to 8 weeks.~   "
92504|NCT02356328|"~     This observational study is intended to collect outcome data from a cohort of 30 patients~     suffering from dry eye disease due to chronic ocular Graft-versus-Host Disease (GvHD) who are~     treated with the medical device NovaTears® eye drops for a duration of 11 to 13 weeks.~   "
92507|NCT02356289|"~     The purpose of this study is to establish initial safety, tolerability, pharmacokinetics and~     pharmacodynamics of MYK-461 in human subjects. This is a randomized, double-blind,~     placebo-controlled, sequential group, single ascending (oral) dose study in healthy~     volunteers aged 18-55 years.~   "
92508|NCT02356276|"~     HIPEC-01 is a prospective, open, randomized multicenter phase III clinical study conducted in~     China. To determine the efficacy of hyperthermic intraperitoneal chemotherapy (HIPEC) in the~     treatment of locally advanced gastric cancer, patients are randomized into HIPEC group and~     control group. In HIPEC group, the patients undergo radical gastrectomy with D2~     lymphadenectomy and HIPEC with paclitaxel and postoperative chemotherapy. Patients in the~     control group just undergo radical gastrectomy with D2 lymphadenectomy followed by~     postoperative chemotherapy. Patients in both groups receive 6-8 cycles of postoperative~     systemic chemotherapy (XELOX or SOX regimens) and are followed up for 5 years or until death.~   "
92509|NCT02356263|"~     Stressors impair optimum function of an individual physiologically and psychologically.~     Overcoming stress is possible when one knows which aspects of life are the most troublesome~     to manage for individuals. There are certain tools available in Pakistan that can measures~     stress in selected populations but there are no validated tools that may quantify stress~     which results from events occurring in different aspects of life.~      Recent Life Changes Questionnaire (RLCQ) is a tool that measures stress of individuals~     through life changing events. It has five categories; work, home and family, health, personal~     and social and financial. The objective of the study is to adapt RLCQ and validate it so that~     it may measure stress among people living in Karachi, Pakistan.~   "
92510|NCT02356250|"~     Rationale for the study:~      To try and define PEF in cirrhotic patients with CSPH, and maybe to try to find a correlation~     between HVPG result and PEF result in a way that the result of the PEF test will be able to~     predict if a patient has CSPH (yes of no). By this, to try and develop a portable~     office-based device that can produce immediate results in a non-invasive manner in cirrhotic~     patients and help in evaluating prognosis in these patients in a noninvasive manner.~      Aim:~      The aim of this study is to try and characterize the peripheral endothelial function (PEF) in~     patient with cirrhosis and CSPH. This will be evaluated by measuring the PEF in every patient~     before evaluating his HVPG level in a hemodynamic study.~   "
92511|NCT02356237|"~     This study is aimed to evaluate the influence of episiotomy on various maternal and neonatal~     outcomes. Half of the participants will undergo selective episiotomy (according to routine~     delivery management at the particular hospital), while the other half will not undergo~     epitiotomy at all.~      Our hypothesis is that no differences in maternal and neonatal outcomes will be demonstrated~     between these two groups.~   "
92512|NCT02356224|"~     SHR3824 is a novel inhibitor of renal sodium-glucose cotransporter 2, allows an~     insulin-independent approach to improve type 2 diabetes hyperglycemia. In this single-dose~     study the investigators evaluated the safety, tolerablity and PK/PD profiles of SHR3824 in~     healthy subjects.~   "
92513|NCT02356211|"~     Objective To reduce subsequent falls following Multifactorial Falls Assessment Design:~     Prospective Case Control~      Population: Frail elderly Veteran outpatient population referred for falls assessment~      Methods: Prospective controlled trial of Geriatric Multifactorial Falls Assessment Clinic~     patients followed for 1 year and outcomes compared to Falls e-Consult Clinic (chart review)~     and Acute Geriatric Evaluation and Management (GEM) Inpatient Unit discharge control groups.~   "
92514|NCT02356198|"~     This study is prospective, randomized trial in which EXPAREL TAP block is compared to~     standard IT opioid administration, in relieving postoperative pain, decreasing length of~     stay, and use of narcotic medication.~   "
92515|NCT02356185|"~     Background:~      Data are scarce concerning injecting drug use (IDU) and alcohol consumption among~     HIV-infected people on highly active antiretroviral treatment (HAART) in Cameroon. The aim of~     this study is to determine the prevalence of alcohol consumption and IDU among HIV-infected~     people on HAART; to determine sociodemographic factors associated with alcohol abuse and IDU~     among people on HAART; and to determine impact of alcohol consumption and IDU on adherence to~     HAART.~      Methods/Design:~      The investigators will conduct a cross sectional study at the Yaoundé Central Hospital in~     Cameroon, from February to August 2015. Using a self-report questionnaire, the investigators~     will include at least 1,000 HIV-infected adults (18 years or more) on HAART for at least one~     month coming for HIV care. The investigators will exclude pregnant women. Data collection~     will include sociodemographic and economic profile, alcohol consumption using Alcohol Use~     Disorders Identification Test, injecting drug use, adherence to HAART using visual analog~     scale and self-rate report. The investigators will perform sub-analysis for sex group and~     area of habitation. A p value < 0.05 will be considered statistically significant.~      Discussion:~      There is a critical need of accurate estimates of the amplitude and the distribution of IDU~     and alcohol consumption among HIV-infected adults, in order to inform health policies maker~     for curbing burden of both injecting drug use and alcohol consumption among people living~     with HIV.~   "
92516|NCT02356172|"~     Background:~      - Isolated (or Congenital) GnRH Deficiency (IGD) is a rare disease. People who have this go~     through puberty late. Some never reach puberty or don t complete it without treatment. They~     also may have an impaired sense of smell or other health problems. Research shows that~     disorders like this can have a negative effect on a person s psychological profile.~      Objective:~      - To understand the psychological outcomes in people with IGD. These can include depression,~     anxiety, poor health, and poor social function.~      Eligibility:~        -  Adults age 18 and over with IGD. They must be currently on a full dose of hormone~          replacement therapy for at least 3 months.~        -  Healthy adult volunteers.~      Design:~        -  Participants will get a username and password. This will give them access to questions~          online. They can do this from any computer connected to the Internet.~        -  Participants will log in and complete the questionnaires. There are 5 total, but they~          will appear as 1 continuous set of questions. Answering them takes about 1 hour or less.~        -  The first set is about the participant s disorder. The rest ask about depression,~          anxiety, global health, and social function.~        -  All answers will be used for research and to better understand reproductive disorders.~          Only researchers from the NIH Unit on Genetics of Puberty and Reproduction and from this~          study will know which answers belong to which participant.~   "
92517|NCT02356159|"~     Background:~      - In allogeneic stem cell transplantation (SCT), stem cells are taken from a donor and given~     to a recipient. Sometimes the recipient s immune system destroys the donor s cells. Or donor~     immune cells attack the recipient s tissues, called graft-versus-host disease (GVHD). This is~     less likely when the recipient and donor have similar human leukocyte antigens (HLA).~     Researchers want to see if the drug palifermin improves the results of allogeneic SCT from~     HLA-matched unrelated donors.~      Objective:~      - To see if high doses of palifermin before chemotherapy are safe, prevent chronic GVHD, and~     improve immune function after transplant.~      Eligibility:~      - Adults 18 70 with blood or bone marrow cancer with no HLA-matched sibling, but with a~     possible HLA-matched donor.~      Design:~        -  Participants will be screened with medical history, physical exam, and blood and urine~          tests. They will have scans and heart and lung exams.~        -  Before transplant, participants will:~        -  Have many tests and exams. These include blood tests throughout the study and bone~          marrow biopsy.~        -  Get a central line catheter if they do not have one.~        -  Have 1 3 rounds of chemotherapy.~        -  Take more tests to make sure they can have the transplant, including medical history,~          physical exam, and CT scan.~        -  Get palifermin by IV and more chemotherapy. They will get other drugs, some they will~          take for 6 months.~        -  Participants will get the SCT.~        -  After transplant, participants will:~        -  Be hospitalized at least 3 4 weeks.~        -  Have tests for GVHD at 60 days and 6 months. These include mouth and skin photos and~          biopsies.~        -  Stay near D.C. for 3 months.~        -  Visit NIH 5 times the first 2 years, then yearly. They may have scans and biopsies.~   "
92518|NCT02356146|"~     Tacrolimus dose highly varies among Asian kidney transplant recipients. This can be explained~     by variety of CYP3A5 expression. CYP3A5 genotyping is highly recommended for patients~     receiving tacrolimus. Here, we assessed the tacrolimus dose prediction by comparing CYP3A5~     expression and tacrolimus dosage using tacrolimus concentration after single dose~     administration prior to kidney transplantation.~      Plasma tacrolimus trough level was measured at 12 hours after first dose of 0.1 mg/kg of~     tacrolimus (TacC12), orally administered in 51 new kidney transplant recipients. Patients~     with CYP3A5 inhibitor/inducer co-medications were excluded. Genotyping for CYP3A5 expression~     were carried out by RT-PCR. The dosages of tacrolimus at post-operative day 7 and dosage~     which provided stable therapeutic levels in post-operative month 1 to 3 (C0 5-8 ng/mL) were~     recorded.~      The genotyping, TacC12, and target tacrolimus dosage have good correlations.~   "
92519|NCT02356133|"~     record,describe and discuss the relationship among rSO2, MAP,CAM value, vital organ~     disfunction and the outcome of patients after operation by Near-Infrared Spectroscopy in~     Endovascular Neurosurgery~   "
92520|NCT02356120|"~     The purpose of this study will be to evaluate the measurement of tricuspid annular plane~     systolic excursion (TAPSE) by emergency physician performed echocardiogram on patients with~     suspected pulmonary embolism (PE) who are scheduled to get a computed tomography of the~     pulmonary arteries (CTPA)~   "
92521|NCT02356107|"~     The investigators hypothesize that the administration of two widely available, naturally~     occurring dietary supplements, 5 hydroxytryptophan and creatine monohydrate, will reduce the~     severity of depression in individuals exposed to chronic hypoxia by living at altitude. The~     purpose of this study is to determine if 8 weeks of dietary augmentation with oral 5 g~     creatine daily and 100 mg 5-HTP twice daily reduces hypoxia-related depressive symptoms~     measured by the 17-item Hamilton Depression Rating Scale (HAM-D) in women with SSRI or~     SNRI-resistant depression.~   "
92522|NCT02356094|"~     Characterization of posterior corneal changes in primary open angle glaucoma patients, using~     Scheimpflug examination.~   "
92523|NCT02356081|"~     Chemotherapy may cause distressing symptoms which can impact on patients' quality of life.~     Chemotherapy is frequently given on an outpatient basis therefore patients are often required~     to manage the symptoms they experience at home without direct supervision from healthcare~     professionals. This study aims to evaluate the impact of a mobile phone based, remote~     monitoring, symptom management system (ASyMS) on the delivery of care to people with~     nonmetastatic breast, colorectal or haematological cancer during chemotherapy and for one~     year following treatment. The study aims to compare a number of outcomes of patients using~     the ASyMS intervention with outcomes of patients who receive normal care at their hospital.~     For up to 6 cycles of chemotherapy treatment, once a day and any other time they feel unwell,~     patients allocated to the mobile phone group will enter information on the phone regarding~     any symptoms they are experiencing, take their temperature and enter this on the phone. The~     information is sent via secure connection to a computer, which assesses the information and~     sends an alert to their health care professional in the hospital, who will call the patient~     at home if the patient has reported problematic symptoms. Patients in the normal care group~     will receive care as normal at their hospital. Both groups of patients will be asked to~     complete a series of questionnaires before they start treatment, after each chemotherapy~     cycle (for a maximum of 6 cycles) and at 3 monthly intervals for up to one year thereafter (a~     subset of patients will also be asked to complete midcycle symptom assessments). The study~     will also evaluate the cost benefit of ASyMS, assess changes in clinical practice as a result~     of ASyMS and develop a predictive risk model (statistical model) for use in future care of~     patients receiving chemotherapy for these cancers. This multicentre study is taking place~     across a number of European countries.~   "
92524|NCT02356068|"~     Patients with cirrhosis present complex coagulation defects. Conventional coagulation tests~     (INR, platelets count) can not predict bleeding or blood product requirements during liver~     transplantation. Thromboelastometry (TEM)analyser measures the viscoelastic of the whole~     blood coagulation generation and lysis. TEM results are available more rapidly than~     conventional tests and give additional information regarding coagulation strengh, platelet~     function, and fibrinolysis.~   "
92525|NCT02356055|"~     People with Alzheimer's disease and related dementias present with changes in how they think,~     move and emotionally respond to daily life situations. While type of dementia will dictate~     how severe certain symptoms are, all people with dementia will report a gradual change in how~     they function in daily life skills. Losing the ability to do daily life tasks, such as using~     a cell phone, balance a checkbook or get dressed in the morning signifies loss for both the~     person with dementia and their caregiver. Caregivers that assist with daily life tasks report~     more depression and anxiety, as well as a higher burden of care. People with dementia that~     lose the ability to perform daily tasks report more depression and decreased satisfaction~     with life. Despite gains in research, researchers are still missing important pieces that~     will improve rehabilitation interventions for improving daily life skills.~      In order to address the needs of people with dementia, an intervention called Skill-building~     through Task-Oriented Motor Practice (STOMP) was developed by an occupational therapist. Our~     team proposes that improvement in daily life skills is possible under certain circumstances.~     First, the daily life task a person is addressing in rehabilitation should be~     personally-meaningful and should also be the task practiced in therapy which is called~     task-oriented training. For example, a person that is having trouble making a sandwich~     should practice making a sandwich. Second, the investigators propose that people with~     dementia need a lot of correct practice so that the brain has time to rewire how to do~     the task correctly. Therefore, when patients practice tasks using STOMP, investigators do not~     allow our participants to make errors and patients practice for long periods of time.~     Investigators also incorporate and provide new technology into training such as medication~     reminder alarms and photo phones which allow you to dial a number by choosing a loved one's~     picture.~      In this pilot study, the investigators want to look more closely at the how the amount of~     time you practice influences study outcomes. The investigators believe that the findings from~     this study will support our belief that more time in therapy is needed to enhance how someone~     with dementia learns.~   "
92527|NCT02356029|"~     The primary objective of this study is to determine how often cardiopulmonary resuscitation~     (CPR) is perceived as inappropriate by Healthcare Providers (HCPs) working in prehospital~     Ambulance Services and Emergency Departments. Perception of inappropriate CPR is defined as~     resuscitation efforts perceived by HCPs as disproportionate to the expected prognosis of the~     patient in terms of survival or quality of life.~      When a HCP perceives CPR as inappropriate, this may cause moral and emotional distress. This~     perception may be modulated by the personal background and professional role of the HCP, but~     also by his/her working conditions. Apart from the workload, the resulting distress can be~     influenced by the way non-technical skills are developed within the team and the ethical~     environment in which the HCP functions. Frequent exposure to similar patient care situations~     and/or a professional environment not acknowledging the distress may lead to deficient coping~     mechanisms and accumulation of moral distress. This may be associated with job leave, burnout~     and a decreased quality of patient care. Acute distress may also influence the quality of~     care provided to actual and future patients.~      Secondary objectives of the study are to evaluate whether perceived inappropriateness of CPR~     is not only associated with patient related factors but also with personal characteristics~     and work related factors. Potential consequences for HCP's like moral distress and~     intentional job leave will be assessed.~   "
92528|NCT02356016|"~     The aim of the study is to determine the effect of whole body electromyostimulation (WB-EMS)~     and/or nutritional on body composition and functional tasks in elderly females with~     sarcopenic obesity. Seventy-five, non-sportive, independently living women 70 years and older~     with Sarcopenic Obesity were randomly assigned to either a WB-EMS group ( n=25), a~     WB-EMS/nutritional supplements (n=25) or a semi-active control group (an=25). The WB-EMS~     protocol applied one session of 18 min/week of WB-EMS (bipolar, 85 Hz). Nutritional strategy~     based on a high protein supplement.~   "
92529|NCT02356003|"~     Tics are the core symptom of Tourette syndrome. These are repetitive, sudden, semi-voluntary~     movements or sounds. In some children, these tics can be especially bad and require~     treatment, however, options are limited. It is only with time and practice that youth with~     Tourette syndrome are better able to suppress their tics. For these reasons, new~     interventions are needed. The investigators will target a brain region involved in tics~     called the supplementary motor area. Using low frequency repetitive transcranial magnetic~     stimulation, the investigators will inhibit the activity, in a similar way to the tic~     suppression that develops with age. The investigators propose the following objectives: (Aim~     1) The investigators hypothesize that Tourette syndrome symptom severity (as measured by the~     Yale Global Tic severity Scale) will decrease with low frequency repetitive transcranial~     magnetic stimulation targeting the supplementary motor area. (Aim 2) The investigators~     further hypothesize that improvement in Tourette syndrome symptoms will be moderated by low~     frequency repetitive transcranial magnetic stimulation induced changes in GABA and glutamate~     in the supplementary motor area, and changes in the functional connectivity between the~     supplementary motor area and primary motor cortex. Eleven children (7-12 years of age) with~     Tourette syndrome will be undergo low frequency repetitive transcranial magnetic stimulation~     (five times a week for three weeks). After the three weeks, they will look for changes in tic~     severity and brain chemistry and function. By developing a novel avenue for treating Tourette~     syndrome, they can directly impact the care of children by reducing the severity of tics and~     improving quality of life.~   "
92530|NCT02355990|"~     The study objective is to demonstrate the safety of Minimally Invasive Micro Sclerostomy~     (MIMS) device for lowering elevated IOP in patients diagnosed with glaucoma.~   "
92531|NCT02355977|"~     To evaluate the respective or combinatory efficacy of locally delivered 2% Minocycline (MO)~     and surface and root planning (SRP) by assessing both clinical parameters and the loads of~     four main periodontal pathogens in treating chronic periodontitis.~   "
92532|NCT02355964|"~     This project aims to study the effects of lifestyle changes on asthma and systemic~     inflammation in a randomized clinical trial of diet and exercise. The project is a~     multidisciplinary collaboration in the areas of medicine, physiology and nutrition, centred~     on improving asthma control in non-obese sedentary asthmatics via simple means.~   "
92533|NCT02355951|"~     Objectives:~      Primary Objective:~      To identify and preselect patients with chronic HBV mono infection, who are undetectable for~     anti-Ad5 nAb, currently being treated with nucleo(t)sides, for participation in the TG1050.02~     Phase1/1b First in Man (FIM) study.~      Secondary Objectives:~      To assess the prevalence of undetectable anti-Ad5 nAb in chronic HBV mono-infected patients.~      Methodology:~      Patients with chronic HBV mono-infection, who are currently being treated with nucleo(t)sides~     for their HBV infection, will be enrolled in this study to measure Ad5 nAb levels. A single~     peripheral blood collection (4 mL) will be obtained and Ad5 nAb titers will be measured by a~     central laboratory using a newly validated assay.~   "
92534|NCT02355938|"~     The primary purpose of this study is to compare the clinical outcomes of cure and recurrence~     of Clostridium difficile infection in spinal cord injured patients who are treated with oral~     Fidaxomicin vs. oral Vancomycin. The secondary aim of this study is to compare the overall~     costs of treatment of Clostridium difficile infection in the two study groups.~   "
92535|NCT02355925|"~     The present study is designed as a pilot study with 150 patients in each group. Data~     collection form will be filled by the researcher who does not know the type of intervention~     in each group. Data analysis will be done through descriptive and perceptive statistical~     methods by using SPSS software version 20 for windows~   "
92536|NCT02355912|"~     The purpose of this study is for transfemoral amputees to walk with an experimental robotic~     prosthesis. Electric signals will be measured from their muscles and used to help control an~     artificial leg. The investigators will record from sensors placed on a prosthesis and~     electric signals measured from muscles in the participants leg to see if the investigators~     can develop better computer programs to help predict subject actions and prostheses function.~   "
92537|NCT02355899|"~     This study evaluates the potential usefulness of photodynamic therapy with PD P 506 A in~     patients with distal subungual onychomycosis of the great toenail. Patients will receive four~     PDT treatments with PD P 506 A in weekly intervals.~   "
93450|NCT02343952|"~     This is an open label, multi-institutional, single arm phase II trial of consolidation~     therapy with pembrolizumab, following initial treatment with concurrent chemoradiation in~     patients with inoperable or unresectable stage IIIA or IIIB NSCLC. No randomization or~     blinding is involved.~   "
92538|NCT02355886|"~     This randomized phase II/III trial studies gabapentin in reducing the need for pain~     medication in patients with bladder cancer undergoing surgery to remove the bladder and~     nearby tissue and organs. Gabapentin may reduce the amount of pain medicine required after~     surgery, improve pain after surgery, and/or reduce the length of hospital stay after surgery.~   "
92539|NCT02355873|"~     CRRT patients are generally critical ill patients with unstable conditions, such as low blood~     pressure,severe SIRS,et al. Acute kidney injury(AKI)is especially prevalent,with even two or~     more organ failure. CRRT serves as an important supportive therapy.Continuous anticoagulation~     is needed to prevent treatment interruptions due to clotting of the extracorporeal circuit.~     Unfractionated heparin or low molecular weight heparin both increase the risk of bleeding and~     heparin induced thrombocytopenia in such cases.However, the problem of CRRT without~     anticoagulation is the early filter clotting. An alternative method is the use of heparin~     coated hemofilter. The AN69 ST hemofilter, a surface-treated polyacrylonitrile membrane~     hemofilter, allows irreversible fixing of heparin to filter membrane, is able to reduce~     thrombogenic properties of the membrane. In this study, we observe the efficacy and safety of~     heparin-coated AN69 ST hemofilter in CRRT patients, and compare to the original AN69 membrane~     hemofilter.~   "
92540|NCT02355860|"~     In an urban gynecology practice serving patients with publicly and privately funded~     insurance, female sexual dysfunction was associated with low income, depression, urinary~     incontinence, and sexual inactivity.~   "
92541|NCT02355847|"~     Additional educational training lectures were provided to healthcare workers. Outcome measure~     of cultural competency was completed to assess patient safety, risk management, and cultural~     competency of healthcare providers in an urban academic Labor and Delivery Unit.~   "
92542|NCT02355834|"~     Inflammatory Bowel Disease (IBD) affects 250,000 adults in the United Kingdom (UK) and causes~     bouts of diarrhoea which are hard to control. Over a quarter of patients experience extremely~     distressing faecal incontinence (FI). Even when the disease is in remission, the majority of~     patients live in fear of not finding a toilet in time. This curtails their activities and~     quality of life. The National Institute for Clinical Excellence (NICE 2007) has issued~     national guidance on actively asking patients about FI and a step-wise care plan for managing~     FI. However, this has not been evaluated in people with IBD, the vast majority of whom do not~     ask for help, even when they have frequent FI.~      Across six expert centres in the UK, the investigators will perform 3 linked studies: [1] The~     investigators will screen people with IBD, offering the opportunity to obtain help with bowel~     control. The investigators will compare uptake of a postal approach versus response to a~     proactive face-to-face asking approach at a physical or telephone clinical appointment. [2]~     The investigators will conduct a randomised controlled trial (RCT) comparing two different~     approaches (IBD nurse specialist plus self-help booklet versus self-help booklet alone) to~     see which one produces the best results in terms of reductions in FI, other symptoms, costs~     and quality of life at 6 months after intervention. Booklet group participants may access the~     nurse intervention at 6 months if they wish, when the RCT is finished. [3] Interviews will be~     performed at the end of the intervention, gathering patient views and preferences and staff~     perspectives via Qualitative interviews and free text questionnaire comments, to enable a~     rich understanding and interpretation of our results.~      The investigators will disseminate the results widely to people with IBD and health~     professionals and take active steps to embed successful interventions in NHS services, having~     gained sound evidence on how many people want help, whether intervention is effective in~     improving FI, and patient and staff views on interventions.~   "
92543|NCT02355821|"~     This study evaluates the effect of moxonidine versus bisoprolol on collagen type 1~     C-telopeptide in postmenopausal female patients with arterial hypertension and osteopenia.~   "
92544|NCT02355808|"~     Lack of internet infrastructure, personal skills, and service provision have been identified~     as potential barriers to e-health but as yet there is no good evidence of the impact of~     interventions to improve them. This study aims to assess impact on e-health uptake of three~     interventions (i) superfast broadband, (ii) a tailored leaflet to help participants improve~     personal internet skills and support, (iii) GP interventions to improve health service~     provision of e-health. In a cluster randomised factorial controlled trial, 1388 households~     from 78 postcodes were randomly selected from the 20088 Cornish postcodes and allocated to~     the 8 (2X2X2) arms of the study. Comparison of 'e-health readiness' and 'miles travelled'~     from baseline to 18 month follow-up between the 8 arms of the study, will be used to assess~     the effects of interventions, singly and in combination.~   "
92545|NCT02355795|"~     The aim of the current study is to evaluate the effects of diets with three levels of dietary~     fat on weight change and related cardiometabolic risk factors in a 6-month randomized~     controlled-feeding trial.~   "
92546|NCT02355782|"~     The purpose of this compassionate use study, for two patients with thrombotic~     microangiopathy, is to provide expanded access to patients who have participated in the~     clinical trial OMS721-TMA-001 and in whom improvement in their disease markers was observed~     while on treatment or to patients who could otherwise benefit from the treatment. This is a~     treatment protocol; not a research protocol.Therefore, only patients in study OMS721-TMA-001~     deemed eligible by the investigator may participate.~   "
92547|NCT02355769|"~     Preventing heart failure (HF) deterioration is a great challenge for contemporary medicine.~     The progress course of HF is with increasing frequency of subsequent hospitalizations~     (approximately 30% of hospitalizations are the repeated ones). It is estimated that the costs~     of hospital stays constitute nearly 2/3 of healthcare costs provided for HF patients. The~     difficulty in treatment of patients with HF deterioration is associated with numerous~     comorbidities and coexisting complications (i.e. aggravation of ischaemic heart disease, lung~     diseases, infections, electrolyte disturbances, anaemia, renal failure as well as operations,~     in particular emergency ones). Our study is aimed to evaluation the complex~     pathophysiological background related to heart failure deterioration with respect to the~     effect of applied in-hospital treatment.~   "
92548|NCT02355756|"~     This will be a single center, open-label study in healthy male subjects between 18 and 45~     years old to determine the dose response profiles of dermal blood flow in response to~     intradermal injections of maxadilan. The study will consist of 2 parts: Part I: dose and time~     finding and Part II: reproducibility over time.~   "
92549|NCT02355743|"~     The primary research question is, in patients with short bowel syndrome requiring central~     venous access device (CVAD) for long-term total parenteral nutrition, is once weekly~     recombinant tissue plasminogen activator (rtPA) lock therapy more effective than routine care~     using heparin flushes in reducing the incidence of line-associated thrombosis and infection.~   "
92589|NCT02355223|"~     The study is designed to evaluate the clinical impact of a novel strategy for tuberculosis~     (TB) infection control known as FAST (Find cases Actively based on cough surveillance,~     Separate temporarily, and Treat effectively). It is anticipated that this will decrease time~     to effective treatment initiation and also decrease transmission of TB to health care~     workers.~   "
92550|NCT02355730|"~     This study is to further develop and optimise the design and manufacturing process of a~     handheld device to monitor and manage Warfarin (blood thinning anticoagulation drug) therapy.~     The device comprises of a handheld instrument and a disposable test strip and reports how~     blood coagulation is working in terms of standardised units called International Normalised~     Ratio (INR). A single drop of fresh whole blood and plasma will be added to the strip and the~     INR result displayed on the instrument. Blood samples are to be collected from patients~     attending a hospital based INR clinic who are on Warfarin Therapy. The samples are to be used~     in a series of experiments in the laboratory to test the Microvisk POC INR Monitors accuracy,~     precision, stability and robustness.~   "
92551|NCT02355717|"~     The proposed research brings together complementary expertise to systematically elucidate the~     longitudinal effects of (1) total and regional body fat and (2) the metabolic impairment that~     accompanies obesity on bone development during growth. The contribution of this research will~     be significant because it will provide a solid foundation for understanding the influence of~     fat (total and regional distribution) on overall bone strength, and whether insulin~     resistance, beta-cell dysfunction, abnormal lipids, and inflammation could be underpinning~     factors in the fat-bone strength relationship via effects on bone modeling activity. This~     knowledge will provide critical information needed to maximize potential therapeutic~     interventions to counter the linked risks of obesity and osteoporosis, both major public~     health concerns.~   "
92552|NCT02355704|"~     Renal Insufficiency is a priority disease in health system, which may require renal~     replacement therapy based on renal transplantation, which is considered as therapy of choice.~     During the procedure of renal transplantation, the graft could be damaged by~     ischemia-reperfusion which generates complications in its function.~      Recently the anti-inflammatory and immunomodulatory effects of statins have been emphasized,~     which could be beneficial in renal transplantation.~   "
92553|NCT02355691|"~     For the target population of adult patients following primary total hip arthroplasty, the~     randomized clinical trial will be used to evaluate the efficacy of the use of a mobile~     negative pressure wound therapy(NPWT) device compared to a standard absorptive dressing in~     the immediate postoperative period. We will apply two dressing types and evaluate the~     postoperative wounds with a wound scoring system (ASEPSIS) that incorporates multiple~     variables of wound infection risk.~   "
92554|NCT02355678|"~     Tonsillectomy is one of the most frequent surgical operations performed in children [1-4]. It~     is usually associated with postoperative nausea and vomiting (PONV) with an incidence ranging~     from 23% to 73% [2]. Dexamethasone has been shown to be effective in reducing PONV after~     tonsillectomy using standardized anesthetic technique [2, 5-7]. Previous studies utilizing a~     different technique, the pre-incision infiltration of local anesthesia, had shown to decrease~     post-tonsillectomy pain, reduce analgesic consumption and provide a rapid return to normal~     activity [8, 9]. Given the effectiveness of dexamethasone and the pre-incision infiltration~     anesthetic technique, it would be beneficial to compare the effect of each on PONV.~   "
92555|NCT02355665|"~     The purpose of this study is to assess the efficacy and safety of a novel nicotine product~     for continuous abstinence from smoking. Efficacy of product will be evaluated by assessments~     of self-reported abstinence, verified by exhaled carbon monoxide (CO) levels.~   "
92556|NCT02355652|"~     The goal of this prospective randomized double-blind study is to compare clinical and~     radiological results of cemented and uncemented total knee arthroplasty (TKA).~      Two hundred and fifty patients will be randomized in two groups : cemented TKA and uncemented~     TKA.~      The primary outcome is the comparison of the International Knee Society (IKS) Score revised~     in 2011 at one year postoperative.~      The second outcome is the comparison of standard one year-postoperative x-rays looking for~     signs of loosening.~   "
92557|NCT02355639|"~     The purpose of this study is to assess steroid induced skin atrophy by sonography.~   "
92558|NCT02355626|"~     Anxiety is commonly considered as an epiphenomenon of the cognitive and emotional response to~     a threat. Anxiety is a consequence of the reciprocal interaction between stress and the~     neuroendocrine, autonomic and immune systems. A systematic and circumstantial assessment of~     anxiety in critically ill patients has never been done. Our hypothesis is that high levels of~     anxiety at ICU admission are associated with death or the occurrence of one or more organ~     failure during the first 7 days, and that anxiety should be considered as a warning sign in~     critically ill patients.~   "
92559|NCT02355613|"~     Randomized double arm phase III study to evaluate feasibility and safety of Gamma Knife~     radiosurgery and Linac Based (Edge) radiosurgery in brain metastatic patients~   "
92560|NCT02355600|"~     Survival in young patients with cancer has increased and also have increased the adverse~     long-term side effects of chemotherapy, there is a large number of women who experience loss~     of ovarian function without accomplishing their reproductive desire due to gonadotoxic~     treatment. The ovarian reserve determine the response to controlled ovarian hyperstimulation~     in fertility preservation treatments as well as in assisted reproduction techniques.~     Improving this reserve by avoiding its depletion during the process could result in increase~     fertility rates after cancer treatment.~      Collecting follicles during tamoxifen treatment would increase the number of cryopreserved~     oocytes and thus rise the potential ovarian reserve in these patients, which is reduced due~     to age, chemotherapy and length of treatments.~      The aim of this study is to retrieve viable mature oocytes during adjuvancy with tamoxifen in~     breast cancer patients to improve the probability of subsequent pregnancy.~   "
92561|NCT02355587|"~     The EXPAND Registry Study follows patients with cutaneous melanoma who have had the~     DecisionDx-Melanoma gene expression assay performed as part of their clinical care. Data will~     be collected through review of medical records from clinical visits with physician.~      The purpose is to document the clinical application of results obtained from the DecisionDx-~     Melanoma multi-gene assay and to track outcomes of patients for whom DecisionDx-Melanoma~     testing has been completed. Additionally the study will assess the health economic impact of~     DecisionDx-Melanoma testing as it relates to the Melanoma population.~   "
92590|NCT02355210|"~     This study evaluates the effect of a dietary supplement to improve gut health. The~     participants will take one of six dietary treatments for three weeks, and the gut bacteria~     and the gut intestinal barrier will be assessed to determine if these dietary treatments~     beneficially change these markers of gut health.~   "
92562|NCT02355574|"~     The INTEGRATE Registry Study follows patients with cutaneous melanoma who have had the~     DecisionDx-Melanoma gene expression assay performed. Data will be collected through review of~     medical records from clinical visits with physician.~      The purpose is to document the clinical application of results obtained from the DecisionDx-~     Melanoma multi-gene assay and to track outcomes of patients for whom DecisionDx-Melanoma~     testing has been completed. Additionally the study will assess the health economic impact of~     DecisionDx-Melanoma testing as it relates to the Melanoma population.~   "
92563|NCT02355561|"~     The purpose of this study is to assess the effect of a high-fat/high-caloric breakfast on the~     rate and extent of absorption of the single oral dose of 25 mg JNJ-54861911 test formulation~     in healthy elderly participants.~   "
92564|NCT02355548|"~     This study is looking at the safety and effectiveness of treating Patients diagnosed with a~     low-risk Pulmonary Embolism (PE) in an outpatient setting instead of the standard, in-patient~     hospitalization. Patients have several medical tests done during their Emergency Department~     visit. Based on those tests, those who are determined to have a low-risk PE are eligible to~     participate in the study. Those choosing to participate are discharged after 12 hours of~     medical observation. Patients who choose to participate are followed up by telephone~     approximately 90 days later.~   "
92565|NCT02355535|"~     This Phase I dose escalation study will evaluate Procaspase Activating Compound-1 (PAC-1), a~     small molecule that activates procaspase -3 to caspase-3, resulting in apoptosis of cancer~     cells, in patients with advanced malignancies. PAC-1 is taken orally on days 1-21 of a 28-day~     cycle. The maximum tolerated dose (MTD) of PAC-1 (5 dose levels) will be determined using a~     modified-Fibonacci dose-escalation 3+3 design. Treatment continues until disease progression,~     unacceptable toxicity, physician discretion, or patient refusal.~   "
92566|NCT02355522|"~     This is a randomized, double-blinded, double placebo-controlled trial. Patients undergoing~     saline infusion sonohysterography (SIS) will be recruited and randomized into three groups to~     receive (a) 3ml of 2% lidocaine gel on the cervix and 5ml of intrauterine normal saline; (b)~     3ml of KY jelly on the cervix and 5ml of 2% intrauterine lidocaine or (c) 3ml of KY jelly on~     the cervix and 5mL of intrauterine normal saline prior to SIS. Pain levels will be recorded~     to evaluate the efficacy of local lidocaine gel and intrauterine lidocaine infusion in~     reducing pain during the SIS.~   "
92567|NCT02355509|"~     Is a randomized, double-blind, placebo-controlled trial to determine the behavior of~     hyperglycemia and postprandial lipemia after a standard mixed meal load in patients with~     carbohydrate intolerance treated with acarbose.~   "
92568|NCT02355496|"~     This is a clinical trial to evaluate the impact of presenting medicare fee data for inpatient~     laboratory tests in the electronic health record on provider ordering behavior at a tertiary~     care hospital.~   "
92569|NCT02355483|"~     The purpose of this study is to determine whether non-contrast abdominal computed tomography~     (CT) impacts management (diagnosis, need for surgery and treatment) in elderly patients~     admitted to the emergency department with abdominal pain.~   "
92570|NCT02355470|"~     This study will offer the first formal assessment for sexual violence (SV) in the college~     student health center setting, developed for a high risk group of college students, and is~     designed to facilitate patient and provider comfort in discussing sexual violence and related~     abusive experiences (including the role of alcohol) via semi-scripted screening tools. The~     intervention specifically involves the training of all clinical staff (health educators,~     counselors, medical assistants, nurses, and clinicians) to deliver a universal education and~     brief counseling intervention titled GIFTSS (Giving Information for Trauma Support and~     Safety) to all clients seeking college health services integrated into usual clinical~     practice, provide universal education about SV regardless of disclosure, counsel clients on~     harm reduction strategies to reduce risk for SV, and provide supported referrals to sexual~     assault advocates, with the goal of reducing SV among college students.~   "
92571|NCT02355457|"~     The primary aim of the study is to investigate new cardiac biomarkers and algorithms to~     diagnose acute coronary syndrome in patients with suspected acute myocardial infarction.~   "
92572|NCT02355444|"~     Cardiovascular disease (CVD) is the most common cause of death in Ireland, accounting for 33%~     of all deaths. Hypertension or elevated blood pressure, is also a significant health problem,~     however, it is one of the major controllable risk factors associated with CVD. While~     increased consumption of fruit and vegetables is associated with reduced risk of CVD,~     evidence is accumulating that consumption of berry fruits in particular, may promote~     cardiovascular health. Blackberries have a favourable nutritional profile, in that they are~     rich in dietary fibre, vitamins C, K and folate but low in dietary fat and kilocalories. In~     addition, blackberries are a rich source of antioxidants, and contain numerous phytochemicals~     including polyphenols. The aim of this study is to investigate the potential beneficial~     effects of blackberry consumption on cardiovascular health, in particular, effects on blood~     pressure.~   "
92573|NCT02355431|"~     The purpose of this study is to determine if INCB039110 in combination with erlotinib is safe~     and effective in the treatment of nonsquamous non-small cell lung cancer (NSCLC) that is~     Stage IIIB/Stage IV or recurrent whose tumors have EGFR activating mutations.~   "
92574|NCT02355418|"~     This study investigates the hypothesis that diffuse interstitial cardiac fibrosis develops in~     response to chronic volume overload from severe degenerative mitral regurgitation. The~     investigators will investigate the functional (exercise) and symptomatic (PROMS) outcomes of~     patients with severe but asymptomatic mitral regurgitation who have the option of choosing~     surgical repair or watchful waiting.~   "
92575|NCT02355405|"~     Lung ultrasound offers a novel, reliable and radiation-free tool for diagnosing perioperative~     atelectasis and evaluating its severity in adult patients undergoing general anesthesia in~     the operating room.~   "
92576|NCT02355392|"~     The purpose of this study is to determine the prevalence of hypertension among citizens of~     Holstebro, Denmark aged 55-64 years, including both the well treated, the untreated and the~     insufficiently treated, and to estimate the prevalence of white coat and masked hypertension~     using home blood pressure measurements with telemedical data transmission.~   "
92617|NCT02354859|"~     The purpose of this study is to assess the efficacy of IV gallium to improve pulmonary~     function as measured by a 5% or greater relative improvement in forced expiratory volume in~     one second (FEV1) from baseline to Day 28.~      Funding Source - FDA OOPD~   "
92577|NCT02355379|"~     Colorectal cancer occurs mainly in elderly patients. Recent estimation showed that in France~     more than 50% of the patients diagnosed with a colorectal cancer are 70 years old or more.~     Adjuvant chemotherapy has demonstrated a benefit on disease-free survival and overall~     survival after a stage III colon cancer resection. Nevertheless adjuvant chemotherapy is~     poorly used in elderly patients. Prognostic improvement with chemotherapy based on 5FU is~     suggested by a post-hoc analysis of randomized prospective clinical trial. But elderly~     patients in this study were highly selected and patients older than 80 represented only 0.7%~     of the total population. Thus, there is still a concern about the benefit of adjuvant~     5FU-based chemotherapy in very elderly unselected patients.~      The recommended treatment for stage III adjuvant chemotherapy is a combination of~     fuoropyrimidine and oxaliplatin. Nevertheless oxaliplatin did not demonstrated survival~     advantage in elderly patients.~      Altogether there are still two matters of debate:~        -  First, is there a benefit of fluoropyrimidine-based adjuvant chemotherapy for unfit~          elderly patients?~        -  Second, is there a benefit of oxaliplatin-based adjuvant chemotherapy for fit elderly~          patients? The aim of this randomized phase III study is to evaluate the benefit for~          disease-free survival of adjuvant chemotherapy in elderly patient and which~          chemotherapy.~      The elderly patient population will be dichotomized into two groups according to physician's~     choice after a multidisciplinary evaluation involving a geriatrician, with two different~     randomization assignments. The patients with an expected life-expectancy below 4 years~     according Lee score are excluded of this study.~      Some biological tumour abnormalities are more frequently observed in elderly (i.e. mismatch~     repair deficiency), therefore an evaluation of specific biological prognostic factors is~     needed in elderly population.~   "
92578|NCT02355366|"~     The present study aims to examine the effects of a 4 month, family focused therapy (FFT)~     intervention on the 1 year course of mood symptoms in offspring of parents with bipolar~     disorder (BD). The study will also examine the level of expressed emotion among families and~     how this impacts on FFT treatment outcomes. This study seeks to replicate a previous study by~     Miklowitz, Schneck, Singh, Taylor, George and colleagues (2013), which demonstrated the~     efficacy of FFT among BD offspring. Importantly, the present study will introduce biological~     measures that predict and reflect improvement in symptoms and expressed emotion. These~     markers reflect stress-related biological systems and include saliva samples to ascertain~     cortisol, interleukin-6 (IL-6) and salivary alpha amylase (sAA).~   "
92579|NCT02355353|"~     The primary objective of this study is to correlate the percentage change in apparent~     diffusion coefficient (ADC) between baseline and early therapy (at day 14) with tumor~     regression grade (TRG) measured in the surgical resection specimen.~   "
92580|NCT02355340|"~     This research study is evaluating bone mineral density in childhood cancer survivors who have~     a history of bone fracture.~   "
92581|NCT02355327|"~     This feasibility trial aims at assessing practical issues and feasibility of a future~     randomised controlled trial (RCT) to determine the effectiveness of vibrating vaginal pelvic~     floor training balls for postpartum pelvic floor muscle rehabilitation, at monitoring harms~     of the experimental intervention, and at exploring women´s perspectives on and experiences~     with the interventions and the trial.~   "
92582|NCT02355314|"~     Acute kidney injury (AKI) is common in intensive care unit (ICU) patients and remains~     associated with a dismal prognosis. The diagnosis of AKI relies on functional criteria~     (oliguria and serum creatinine elevation), which carry several important limitations.~     Additionally, the investigators lack biomarker that may predict short term renal prognosis.~      Doppler-based renal resistive index (RI) measurement is a rapid and noninvasive investigative~     tool that may hold promise for early AKI detection in ICU patients or in differentiating~     transient from persistent AKI in selected critically ill patients. Although several studies~     have suggested adequate performance in predicting short-term reversibility of AKI, most of~     these studies were performed in limited patient samples. Additionally, a recent study has~     identified discrepant results regarding its diagnostic performance.~      The main objective of this large prospective multicentre study is to assess diagnostic~     performance of Doppler-based renal resistive index in diagnosing persistent AKI in critically~     ill patients requiring mechanical ventilation.~   "
92583|NCT02355301|"~     The main objective of the investigators is to improve the quality of care in patients with~     orthopedic disorders followed in St Luc hospital (Brussels Belgium). To do this, the~     investigators want to assess the impact of Orthopedic treatments at the structural level~     (bone structure, muscle, etc.), at the functional level (mobility, strength, stiffness...),~     on the restriction of activities of patients (walking, make its care daily..) and on the~     limitation of participation in the life of every day (sport, work, social life, cultural...).~     This functional evaluation of patients with orthopedic disorders by the ICF model is an~     original approach rarely used in muscular-skeletal impairments that can very improve the~     management of these patients and their quality of life. In addition, the investigators~     associate the harvesting of all medical and computer data collected by high-precision tools~     in the surgical treatments, to better define the surgical precision and improve the quality~     of surgical care.~   "
92584|NCT02355288|"~     The purpose of this study is to evaluate whether less invasive bypass surgery using the left~     chest wall artery is more or less effective than inserting a heart stent in patients with~     diabetes and a blockage of the main artery at the front of the heart. This will be a clinical~     trial study where the investigators will test the rate of recruitment into the study, as well~     as the feasibility of allocating each of the 2 treatments.~   "
92585|NCT02355275|"~     The purpose of this study is to determine the effectiveness of a Thera-Band based home~     exercise program (HEP) on LBP and disability 4 weeks post treatment discharge.~   "
92586|NCT02355262|"~     This randomized research trial studies the Community-based Health Information Technology~     (HIT) Tools for Cancer Screening and Health Insurance Promotion (CATCH-UP) intervention in~     increasing cancer screening and prevention care in uninsured patients at community health~     centers. The CATCH-UP intervention may contribute to increased rates of insurance coverage,~     leading to improved cancer screening and prevention rates in community health care settings,~     and general recommended preventive care.~   "
92587|NCT02355249|"~     This study is a multi-center, randomized, and open-label trial to compare the safety and~     feasibility of traditional three incisions and minimally invasive thoracol-laparoscopic~     esophagectomy for esophageal cancer.~   "
92588|NCT02355236|"~     Naxozol is a combination product of naproxen, a non-steroidal anti-inflammatory drug (NSAID)~     and esomeprazole, a proton pump inhibitor which is designed to improve symptoms and reduce~     risk of gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers in~     the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. The~     purpose of this study is to investigate whether naxozol protects the gastrointestinal tract~     effectively compared to celecoxib, a COX-2 inhibitor.~   "
92618|NCT02354846|"~     An Observational Study on Evaluating the Efficacy and Safety of Preemptive Antiviral Therapy~     with Tenofovir in HBsAg-positive Patients with Diffuse Large B-cell Lymphoma Receiving~     Rituximab-CHOP Chemotherapy (SPEED study)~   "
92591|NCT02355197|"~     Fasting and two hours postprandial blood sugar were done to all cases between 28 and 32 weeks~     and high blood sugar levels were found so Cases were controlled by both diet and insulin.~      The 200 pregnant women with Gestational diabetes mellitus were randomized using automated web~     based randomization system into 2 groups, Group1 received 1 gram L-ascorbic acid (vitamin C~     )per day from the time of diagnosis until the time of delivery in addition to routine~     treatment of diabetes (diet & insulin). Group2 received only the treatment of diabetes~   "
92592|NCT02355184|"~     This study is a Phase 2b, multi-center, extension study designed to evaluate the long-term~     efficacy, safety, and tolerability of PRO 140 monotherapy for the maintenance of viral~     suppression in patients who were stable on combination antiretroviral therapy and completed~     12 weeks of treatment under PRO140_CD01 Treatment Substitution Study without experiencing~     virologic failure.~      Consenting patients will continue to receive PRO 140 monotherapy for 160 additional weeks.~     Total treatment duration with PRO 140 will be up to 161 weeks with one week overlap of~     existing retroviral regimen and PRO 140 at the end of the treatment extension phase in~     subjects who do not experience virologic failure.~   "
92593|NCT02355171|"~     The 'Personalize My treatment' (PMT) platform is a novel form of biobanking in which cancer~     patients willingly consent to provide residual, clinical samples (surplus after diagnostic~     testing) of their tumors for cancer research, to give access to their medical record for data~     collection and then followed prospectively throughout the trajectory of their illness. They~     further willingly consent to be recontacted for being informed of other research projects,~     including clinical trials.~   "
92594|NCT02355158|"~     Study CLO-311 is a multicenter, open-label, single-arm study to assess the long-term use of~     Clonidine Gel in the treatment of pain associated with PDN. Subjects who have completed their~     12-week participation in Study CLO-290 or Study CLO-310 are eligible to rollover into this~     study and receive active study drug in an open-label manner.~   "
92595|NCT02355145|"~     A non-interventional, multicentre study to observe the main criteria used in clinical~     practice by physicians when selecting the second-line add-on therapy in patients with~     inadequately metformin-controlled type 2 diabetes in 2 time points at 1 year distance. Data~     will be collected by reviewing the medical records of patients with type 2 diabetes and~     add-on therapies at the time of presenting to endocrinologist according to clinical practice.~     The patients will participate in only one study visit, at the time of enrolment. Two study~     groups are to be defined at two time-points.~   "
92596|NCT02355132|"~     This study examines the impact of a randomized insurance experiment on preventive services~     receipt and healthcare utilization in safety net patients using linked public insurance~     claims and safety net clinics' electronic health record (EHR) data.~   "
92597|NCT02355119|"~     Patients with resected pancreatic cancer who fulfill the selection criteria will be~     randomized to receive one of the two treatment arms for a period of 6 months: Gemcitabine,~     the standard arm, or FOLFOXIRI (the combination of 5-Fluorouracil/Folinic Acid, Oxaliplatin~     and Irinotecan), the experimental arm.~      A total of 310 patients will be enrolled in about 50 Italian centers.~   "
92598|NCT02355106|"~     The objective of the study is to demonstrate the safety and feasibility of the Adagio System~     in subjects with Atrial Flutter.~   "
92599|NCT02355093|"~     This study aims to compare continuous femoral nerve block with adductor canal block after~     anterior cruciate ligament reconstruction arthroscopically，especially in the effect on~     quadriceps strength; and to evaluate which regional anesthesia is more ideal for the patients~     postoperatively.~   "
92600|NCT02355080|"~     This is a randomized controlled clinical trial in which adults receiving drug abuse treatment~     will be recruited to participate in a HIV and hepatitis C (HCV) testing study. The purpose of~     this study is to test the efficacy of two HIV/HCV testing strategies on increasing receipt of~     test results: (1) on-site bundled rapid HIV/HCV testing (i.e., joint offer of HIV and HCV at~     the point of encounter), and (2) standard of care for HIV and HCV testing.~   "
92601|NCT02355067|"~     This study is intended to compare the acceptability and feasibility and explore outcomes~     related to two different formats of a parenting program for mothers with postpartum~     depressive symptoms. One version will be a traditional, in-person group format, while the~     other will be a social media group format. The investigators will also explore the~     differences in outcomes of both formats, looking at depressive symptoms, parenting sense of~     competency, and parenting interactions with children.~   "
92602|NCT02355054|"~     The purpose of this study is to provide clinical access to PET/CT and PET/MRI with C-11~     choline for evaluation of men with biochemically recurrent prostate cancer while awaiting~     approval of the Washington University Abbreviated New Drug Application for C-11 choline.~   "
92603|NCT02355041|"~     Adolescent obesity is associated with a number of serious health conditions and most obese~     adolescents become obese adults. Despite this fact, very few adolescent health centers offer~     clinical weight loss programs. This is likely because most weight loss programs require~     extensive resources and are not covered by most health insurance policies. However, this is~     expected to change since the American Medical Association's recent decision to recognize~     obesity as a disease. Therefore, it is important to identify simple and effective nonsurgical~     programs for weight loss, which can be used in adolescent health centers. The investigators~     are proposing to show that a meal replacement based diet program will be effective in~     reducing body mass index (weight adjusted for height). In this pilot study, 90 adolescents~     will either participate in a meal replacement based weight loss program or watch an~     educational video. Body mass index and body fat will be recorded over time to see if~     adolescents participating in the meal replacement program lose more weight than those who do~     not participate in this program.~      In order to address this objective, the investigators will assess group differences in body~     mass index (BMI; kg/m2), body composition (% body fat), eating disorder symptoms and~     psychological/behavioral variables.~   "
92604|NCT02355028|"~     The purpose of this study is to evaluate the efficacy of 84 successive days of topically~     administered LHA510 compared to vehicle in reducing the number of patients requiring~     intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) therapy (Lucentis®) for~     recurrence of active choroidal neovascularization (CNV).~   "
92712|NCT02353624|"~     The aim of this study was to test the physiological response to a 2800 km cycling expedition,~     from Copenhagen, Denmark to Nordkapp, Norway, in a group of older male recreational cyclists.~   "
92605|NCT02355015|"~     The study aims to address the following aims~        1. To provide an overview of the epidemiology of the patients who are managed in the~          Singapore General Hospital for NTM infections.~        2. To evaluate the medical care of patients in the institution with regards to the type of~          medical and/or surgical treatment received and specifically, the antibiotic regime and~          duration administered.~        3. A longitudinal follow up which will allow an assessment of our care and patient outcome~          in this population cohort~   "
92606|NCT02355002|"~     The purpose of this study is to test the efficacy of 1-Hz repetitive transcranial magnetic~     stimulation (TMS) over the pre-supplementary motor area as a treatment for obsessive~     compulsive disorder. Additionally, this study aims to identify the mechanisms of action of~     TMS and potential biomarkers and predictors of treatment response.~   "
92607|NCT02354989|"~     The purpose of this study is to evaluate the effect on distance covered in a 6 minute walking~     test of Rate Responsive pacing in patients with permanent atrial fibrillation and reduced~     left ventricular ejection fraction treated with atrioventricular junction ablation and~     biventricular pacing.~   "
92608|NCT02354976|"~     This study is a double-blind randomized, placebo-controlled, parallel-group, 12 week study~     performed in 2 centres in Sweden to assess the effect of Omega-3 carboxylic acids and~     fenofibrate on liver fat measured with magnetic resonance imaging (MRI) in patients with~     over-weight and hypertriglyceridemia.~   "
92609|NCT02354963|"~     This study aims to assess whether activation of primordial follicles through ovarian cortex~     fragmentation may increase the number of antral follicles present in the ovary of patients~     with diminished ovarian reserve. Secondary outcomes include number of oocytes retrieved and~     pregnancy rates after IVF.~      Hypothesis; Evaluate whether the proposed intervention increases the pool of antral follicles~     (potentially stimulable ones).~   "
92610|NCT02354950|"~     This will be a Phase 1, open-label, parallel group, two-part, single-dose adaptive study in~     adults with moderate and mild (if needed) hepatic impairment and matched, healthy control~     subjects with normal hepatic function. In Part 1, healthy control subjects (n=8) matched to~     subjects with moderate (n=8) hepatic impairment will be enrolled. If the geometric mean total~     plasma area under the concentration-time curve from time zero (pre-dose) extrapolated to~     infinite time (AUC[0-infinity]) of GSK1265744 is increased by >2-fold in moderately impaired~     subjects relative to matched controls, Part 2 will be conducted to evaluate GSK1265744 PK in~     subjects with mild hepatic impairment (n=8) and matched, control subjects (n=8). All subjects~     will receive a single 30 milligram (mg) oral dose of GSK1265744. The primary objective of the~     study is to compare plasma PK parameters of GSK1265744 in subjects with hepatic impairment to~     healthy controls matched in gender, age, and body mass index (BMI).~   "
92611|NCT02354937|"~     GSK1265744 (744) is an integrase strand transfer inhibitor (INSTI) currently in development~     for both the treatment and prevention of human immunodeficiency virus (HIV) infection. Renal~     elimination of unchanged 744 is extremely low, with no parent 744 detected in the urine after~     a single 30 mg radiolabeled dose. Despite the minimal contribution of renal clearance on~     overall 744 elimination, renal impairment may potentially inhibit some pathways of hepatic~     and gut drug metabolism and transport, and as a result may impact 744 pharmacokinetics. The~     current Food and Drug Administration (FDA) draft guidance for renal impairment studies~     suggests that a pharmacokinetic (PK) study in patients with renal impairment be conducted~     even for those drugs primarily metabolized or secreted in bile.~      The study will be comprised of two cohorts (severe renal impairment and normal renal~     function) of 8 subjects each. Upon enrolment, each subject will be admitted to the study~     center and undergo serial PK sampling following a single dose of oral 744 30 milligrams (mg).~     Subjects will return to the clinic for follow-up evaluations 10-14 days after the 744 30 mg~     dose.~   "
92612|NCT02354924|"~     The purpose of this study is to demonstrate that the VISCO (Olifilcon A) soft contact lens~     could be prescribed as a supportive care for myopic persons.~   "
92613|NCT02354911|"~     The purpose of this study is to determine whether dendritic cells collected via leukapheresis~     and incubated with antisense DNA oligonucleotides and then injected back into the same~     subject will serve as modulators of the immune system in a manner that disrupts the~     autoimmune process responsible for the destruction of pancreatic beta cells in subjects with~     new onset type 1 diabetes.~   "
92614|NCT02354898|"~     This is an open-label, multicenter, phase 1 dose escalation study of BBI503 monotherapy, or~     BBI503 in combination with Sorafenib. This study population is adult patients with advanced~     solid tumors in monotherapy, or adult patients with advanced hepatocellular carcinoma in~     combination therapy.~   "
92615|NCT02354885|"~     Coagulopathy in trauma increases mortality and morbidity. Early administration of tranexamic~     acid (TXA) seems to improve survival and outcome. Thus this study evaluates the~     administration of TXA on scene by the emergency medical services (EMS) or by the crew of a~     rescue helicopter in multiple trauma patients or isolated traumatic brain injury (TBI).~     Coagulopathy will be assessed by standard laboratory tests as well as thromboelastometry.~   "
92616|NCT02354872|"~     The ultimate goal of this research is to develop a chronic care treatment package for smokers~     that will address the challenges and opportunities of each phase of the cessation process -~     motivation, preparation, cessation, maintenance, and relapse recovery. That is, to develop~     treatments for smokers not yet ready to quit, those who are preparing to quit, those actively~     engaged in the quitting process and those who have tried to quit but relapsed. To achieve~     this goal, this research comprises three distinct research studies, each of which represent a~     phase in a comprehensive chronic care treatment model for clinical intervention with smokers~     in the primary care setting: the Motivation Study, the Cessation Study, and the Long-term~     Quitting Study. The goal of each study is to test and identify effective intervention~     components for distinct phases of the smoking cessation process. These components will then~     be combined for future research on the effectiveness of this chronic care treatment package.~     This study is a 2x2x2x2 factorial design. Participants will be randomized to one of two~     levels on four different factors: 1) Nicotine Mini-Lozenge vs. No Mini-Lozenge, 2) Behavioral~     Reduction Counseling (intervention: BR) vs. No Behavioral Reduction Counseling, 3) 5Rs~     Motivation Counseling (intervention 5 R's) vs. No 5Rs Motivation Counseling, and 4)~     Behavioral Activation Counseling (intervention BA) vs. No Behavioral Activation Counseling.~     These components have strong theoretical and empirical support, but their relative, additive,~     and interactive effects are unknown.~   "
92619|NCT02354833|"~     The purpose of the study is to determine if a medication called phenylephrine, which helps to~     control blood pressure, is more effective as a continuous intravenous (IV) infusion compared~     to continuous IV norepinephrine in maintaining blood pressure during a spinal anesthetic for~     a cesarean delivery. Good blood pressure control has been shown to decrease nausea and~     vomiting during and after cesarean delivery under spinal anesthesia. For elective cesarean~     delivery, all participants will receive spinal anesthesia with a local anesthetic and~     morphine (provides long term pain control after cesarean delivery). This study plans to~     enroll 80 pregnant research subjects 18 years and above. Patients will be randomly assigned~     according to a computer generated system to be in one of two groups.~   "
92620|NCT02354820|"~     This project seeks to expand an existing computerized decision support system used in~     pediatric primary care. The expanded system will add a module that helps clinicians recognize~     constipated children and then provides evidence-based reminders for constipation management,~     as well as automates patient educational materials. The current system is deployed across~     multiple sites, and the constipation module will be randomized to deployment in different~     sites. The difference in constipation management and patient outcomes will then be compared~     between sites receiving the intervention and sites not receiving the intervention over a 12~     month period.~   "
92621|NCT02354807|"~     To determine whether pharmacological stimulation of supraclavicular Brown Adipose Tissue (BAT~     or Brown Fat) and subcutaneous White Adipose Tissue (WAT) using an FDA-approved beta3~     agonist is as effective in increasing oxidative metabolism in BAT and WAT as is the exposure~     to cold, the investigators will assess the efficacy of an FDA approved beta3 agonist~     Mirabegron (trade name Myrbetriq, Astellas Pharma, Inc.) for increasing oxidative metabolism~     in supraclavicular BAT and subcutaneous WAT in lean and obese young adults.~      The investigators anticipate that both methods to stimulate supraclavicular BAT and~     subcutaneous WAT will result in similar 18F-labeled fluoro-deoxyglucose (FDG) tracer uptake~     on positron emission tomography (PET) images as well as oxidative metabolism. This would~     demonstrate that pharmacological stimulation of BAT is effective and could lead to further,~     more detailed clinical trials in obese subjects.~   "
92622|NCT02354794|"~     The purpose of this study is to determine whether oral supplementation with one form of~     arginine improves vascular endothelial function in healthy subjects with risk factors~     associated with the metabolic syndrome~   "
92623|NCT02354781|"~     The proposed clinical trial is an outgrowth of the safety record and functional improvement~     seen in the BMD follistatin gene therapy trial. In this study the investigators propose to~     inject AAV1.CMV.huFS344 at a total dose of 2.4E12 vg/kg to six DMD patients. This dose will~     be divided between gluteal muscles, quadriceps and tibialis anterior. This is a wider~     distribution of vector than given to BMD patients, who overall improved the distance walked~     on the 6MWT without adverse events related to viral transduction into a single muscle.~   "
92624|NCT02354768|"~     Dehydration is a major problem of high output stoma with a 17% rate of readmission at 30~     days. Dehydratations are resulting of significant electrolyte loss: sodium, potassium and~     renal failure. Nowadays, there are no recommendations nor national nor international for high~     output ileostomy treatment. Apart from the anti-diarrhea treatments used in current practice,~     somatostatin analogs have proven efficacy in the literature. Theses analogs permit to~     decrease significantly gastrointestinal secretions. Several teams use these analogs in order~     to decrease the flow of highly productive ileostomy.~      The aim of the study is to evaluate the efficacy first line treatment with lanreotide~     associated with current anti-diarrheal treatment for patients with high output ileostomy (or~     greater throughput 1.5l / 24h) with or without associated dehydration~   "
92625|NCT02354755|"~     The purpose of the current study is to examine whether changes in intraoperative ambient~     temperature has in impact on the clinical performance of the physicians in training which~     include Anesthesiology and Surgical residents, fellows and certified nurse anesthetists~     (CRNA). Reaction times will be measured via a 10-minute psychomotor vigilance test (PVT,~     Ambulatory Monitoring Inc., NY) device.~   "
92626|NCT02354742|"~     Echocardiography (cardiac ultrasound) is being used more often in the critical care setting~     for management of severe infection (septic shock). Early studies show echocardiography to be~     useful in these patients, but at this time, there are no good clinical trials to justify its~     use.~      Our study goals/objectives are as follows:~        1. To conduct an unblinded, two-group randomized controlled clinical trial to compare an~          echocardiography-guided resuscitation protocol with an Early Goal Directed Therapy~          (EGDT) protocol in patients with severe sepsis or septic shock.~        2. Demonstrate that a sepsis treatment protocol using transthoracic echocardiography and~          other non-invasive assessments of cardiac output will result in more rapid resolution of~          septic shock compared to invasive EGDT.~        3. Demonstrate patients receiving the non-invasive echocardiography protocol will receive~          less administration of intravenous fluid.~   "
92627|NCT02354729|"~     Fifteen million Americans suffer from food allergies. Food allergies can be life threatening;~     the only known life-saving treatment is epinephrine. Adolescents/young adults are at~     increased risk of adverse events, because of increased risk-taking with food and decreased~     likelihood of carrying epinephrine. This is a pilot randomized trial to test text message~     reminders, with and without financial incentives, to encourage allergic young adults to carry~     epinephrine.~   "
92628|NCT02354716|"~     The purpose of this study is to investigate the use of a functional luminal imaging probe to~     characterize benign esophageal luminal strictures before and after dilation and identify~     predictors of response to therapy. Patients will be evaluated during endoscopy using~     functional luminal imaging (EndoFLIP; Crospon Medical Devices, Galway, Ireland) to~     characterize the geometry of benign luminal esophageal narrowing before and after dilation.~   "
92629|NCT02354703|"~     The primary study objective is to determine the efficacy of ondansetron (0.33 mg twice daily)~     administered orally for a period of 16 weeks in reducing risky drinking among currently~     drinking subjects with alcohol use disorder who have selected genotypes at the serotonin~     transporter and receptor genes. The secondary objective is to assess the safety and~     tolerability of ondansetron in subjects with alcohol use disorder who have selected genotypes~     at the serotonin transporter and receptor genes.~   "
93451|NCT02343939|"~     This study will evaluate the efficacy, safety, and tolerability of entospletinib (GS-9973)~     when administered as monotherapy or in combination with chemotherapy in adults with acute~     myeloid leukemia (AML).~   "
92630|NCT02354690|"~     Background:~      Adoptive T cell therapy with tumor infiltrating lymphocytes (TILs) has been reported to~     induce durable clinical responses in patients with metastatic melanoma. From patients own~     tumor material T cells are extracted, expanded and activated in vitro in a 4-6 weeks culture~     period. Before TIL infusion patients are preconditioned with a lymphodepleting~     chemotherapeutic regimen. After TIL infusion, patients are treated with IL-2 to support T~     cell activation and expansion in vivo.~      The BRAF inhibitor is an approved treatment of metastatic melanoma and functions by~     selectively inhibiting the BRAF mutated enzyme, consequently halting the proliferation of~     tumor cells. Furthermore, in vitro tests have shown that vemurafenib has immunomodulatory~     effects that are hypothesized to synergize with TIL therapy, which has been confirmed in~     animal studies.~      Objectives:~        -  To evaluate safety and feasibility when combining vemurafenib and ACT with TILs.~        -  To evaluate treatment related immune responses~        -  To evaluate clinical efficacy~      Design:~        -  Patients will be screened with a physical exam, medical history, blood samples and ECG.~        -  Patients will start vemurafenib 960 mg BID and will continue during TIL preparation.~        -  7 days after start of vemurafenib, patients will undergo surgery to harvest tumor~          material for TIL production.~        -  Patient stops vemurafenib and is admitted day -8 in order to undergo lymphodepleting~          chemotherapy with cyclophosphamide and fludara starting day -7.~        -  On day 0 patients receive TIL infusion and shortly after starts IL-2 infusion~          continually following the decrescendo regimen.~        -  The patients will followed until progression or up to 5 years.~   "
92631|NCT02354677|"~     COPD is characterized by exagerated decline FEV1 related to obstructive non reversible~     airflow. This could be the consequence of structural changes and inflammatory pattern of the~     bronchial wall. Lesions could lead to normal but also abnormal remodeling specially in COPD~     including a decrease in Club cells number and function.There is no treatment actually~     available targeted to a normal repair of the epithelium. The objective of this work is to~     identify potential targets for reprograming bronchial epithelial cells I order to achieve a~     good repair.~   "
92632|NCT02354664|"~     This study intends to evaluate dynamic respiratory motor performance as a valuable measure of~     pulmonary function in adults with late-onset Pompe disease. The investigators will adopt a~     strategy that includes comprehensive evaluations of respiratory volume, flow, and timing~     parameters during resting and loaded breathing. These evaluations will then be associated to~     the standard clinical measure of maximal inspiratory pressure, the static inspiratory muscle~     function, as well as magnetic resonance imaging of thoracic expansion and diaphragmatic~     descent at rest and with exertion. Outcomes in participants with late-onset Pompe disease~     will be contrasted to the function of age- and gender-matched control subjects. This approach~     will enable the investigators to evaluate the relationship between dynamic diaphragmatic~     function and respiratory motor function.~   "
92633|NCT02354651|"~     The purpose of this study is to determine the effect of diaphragm pacing on respiratory~     function in subjects with Pompe disease by evaluating the duration and pattern of spontaneous~     respiratory function versus paced ventilation respiratory function in patients with Pompe~     disease who have received the NeuDx Diaphragm pacer (DPS).~   "
92634|NCT02354638|"~     In addition to the passengers smoking inside the cab, the taxi drivers,are themselves~     addicted to smoking and/ or use of smokeless tobacco. Since tobacco is highly addictive, the~     cab drivers using tobacco need help in quitting. It is also necessary to raise the awareness~     of the cab drivers with respect to the hazards of tobacco and significance of the smoke free~     legislation.~      It's been six years since the implementation of rules prohibiting smoking in public places~     and a re-look at the compliance to this regulation is necessary. The study will also help~     tobacco users to quit their habits. They will get screened for oral premalignant and~     malignant lesions.~      Also, the cab drivers may pass on some effective messages regarding importance of keeping~     oneself away from tobacco, to the customers while commuting. In view of the above background,~     the current study is proposed to look at all these aspects.~      The findings of the study will be certainly generating useful information with regards to~     lacunae in the existing system for appropriate implementation and for strengthening anti~     tobacco advocacy in our country.~   "
92635|NCT02354625|"~     The purpose of this study is to assess the safety of autologous human Schwann cell (ahSC)~     transplantation in participants with chronic SCI.~      This trial design is phase I, open label, unblinded, non-randomized, and non-placebo~     controlled multiple injury cohorts.~   "
92636|NCT02354612|"~     This is a multicenter, open-label, non-randomized, study of TRC105 in patients that have~     completed a previous TRC105 study and are judged by the investigator to have the potential to~     benefit from continued TRC105 therapy.~   "
92637|NCT02354599|"~     The purpose of this study is to evaluate safety, pharmacokinetics and pharmacodynamics of~     single subcutaneous injection of MT203 in healthy adult Japanese and Caucasian male~     participants.~   "
92638|NCT02354586|"~     This is a Phase 2, open-label, single arm study to evaluate the safety and efficacy of~     niraparib in ovarian cancer patients who have received three or four previous chemotherapy~     regimens. Niraparib is an orally active PARP inhibitor. Niraparib will be administered once~     daily continuously during a 28-day cycle. Health-related quality of life will be measured by~     Eastern Cooperative Oncology Group performance status (ECOG). Safety and tolerability will be~     assessed by clinical review of adverse events (AEs), physical examinations,~     electrocardiograms (ECGs), RECIST tumor assessments and safety laboratory values.~   "
92639|NCT02354573|"~     What is heart failure with normal ejection fraction? The heart contracts (pumps) and relaxes~     with each heartbeat. In some people with heart failure, the heart contracts normally but~     there is reduced relaxation of the heart. As a result, people notice a feeling of~     breathlessness, ankle swelling and fatigue especially on exertion.~      The investigators feel that patients with reduced or impaired relaxation of the heart have~     less heart filling time and poor energy utilisation during exercise. Therefore, the~     investigators are conducting a study to more thoroughly understand the disease condition by~     giving a drug called ivabradine to reduce the heart rate and hence to increase the heart~     filling time in these patients.~   "
92640|NCT02354560|"~     Colorectal cancer (CRC) is a leading cause for cancer related mortality in the western world~     with a lifetime risk of 6%. Etiology is complex, while genetic background significantly~     affects the risk. Around one third of all genetic disorders as well as most cases of Familial~     Adenomatous Polyposis (FAP) and a large proportion of all sporadic CRC cases occur as a~     result of premature nonsense mutations (creating a stop codon) in an individual's adenomatous~     polyposis coli (APC) gene. Nonsense mutations are single-point alterations in the DNA that~     prematurely halt the protein translation process, producing a shortened, nonfunctional~     protein. In many of these cases, if the cell can be 'persuaded' to ignore the premature stop~     codon signal, the resulting protein may be able to ameliorate or stop the disease.~      Recently, members of the aminoglycoside family of antibiotics have been found to induce~     ribosomal read-through of nonsense mutations, leading to expression of a full length,~     functional protein. Investigators have recently shown that members of the aminoglycoside and~     macrolide antibiotic families can induce read-through of the nonsense mutations in the APC~     gene and lead to reduced oncogenic phenotypes in CRC cells and in different mice models.~      The aim of this project is to determine the ability of the macrolide antibiotic-erythromycin~     to induce read-through of the nonsense mutations in the APC gene and to induce expression of~     a full length, functional APC protein in patients suffering from FAP and to tests its effect~     on adenoma number and size and on desmoid tumors in these patients. The future goal is to~     maximize the effect of stop-codon suppressors on APC while minimizing side effects.~      In this study investigators will select FAP patients which carry APC nonsense mutations,~     treat them with erythromycin PO for 4-6 months and examine colonic and duodenal adenomas as~     well as abdominal desmoid tumors, that will be documented before during and after treatment.~     In parallel, investigators will test polyp, adenoma and desmoid tissue samples as well as~     blood samples from these patients for changes in expression levels of the APC protein and~     related oncogenic markers.~      Suppression of nonsense mutations within the APC gene should be of benefit for patients~     suffering from FAP, attenuated FAP or multiple adenomas and for patients with advanced or~     diffuse CRC. Furthermore, given the rapid progress being made in the identification of~     different nonsense mutations in human genes that lead to mostly un-curable disease, the~     identification of clinically approved compounds that suppress nonsense mutations and that can~     be administered long-term without significant side effects would open new venues in the~     treatment of genetic human diseases that arise from pre-mature stop codons in important~     coding sequences.~      Immediate goal: establish the ability of erythromycin to read-through APC nonsense mutation~     in FAP patients. The read-through effect of erythromycin will be clinically tested by~     counting and measuring the number and size of both colonic and duodenal adenomas before and~     over treatment and by measuring the size of known desmoid tumors. Samples of the adenomas and~     desmoid tumors will be tested by western blot, immunofluorescence and immunohistochemistry~     for restoration of APC expression and changes in oncogenic markers. These experiments should~     be conducted within 6 month.~      Long term objective:~        1. Determine the lowest dose of erythromycin that can inhibit growth of colonic neoplasia~          and CRC in patients expressing a truncated APC protein due to nonsense mutations.~        2. Examine the ability of a panel of additional macrolide antibiotics to induce APC~          nonsense mutation suppression using in-vitro methods. Investigators will focus on~          macrolide antibiotics that are currently in clinical use and are administrated for long~          terms. These objectives should take around 6 month and will be conducted in parallel.~   "
92641|NCT02354547|"~     The purpose of this study is to determine the dose limiting toxicities and recommended phase~     2 dose of SGT-53 alone and in combination with topotecan and cyclophosphamide in pediatric~     patients with recurrent or refractory solid tumors.~   "
92642|NCT02354534|"~     This phase I research protocol is designed to assess immunogenicity and clinical endpoints in~     patients with HPV16 CIN2/3. The protocol tests the use of artesunate in suppository~     formulation applied intravaginally in patients with cervical dysplasia (CIN2/3).~      The primary endpoint is to determine and evaluate the safety, tolerability, and feasibility~     of intravaginal administration of artesunate in health women with CIN2/3.~   "
92643|NCT02354521|"~     An observational, point-prevalence cohort study of nutrition therapies in critically ill~     children in PICUs across the world. Baseline information will be collected including PICU and~     hospital demographics and characteristics (e.g. age, diagnostic category, PRISM score,~     weight, height) of critically ill children requiring mechanical ventilation in the PICU.~     Nutrition practices such as route of nutrition, kilocalorie and protein levels prescribed and~     received, interruptions, etc., will be collected on a daily basis from PICU admission~     onwards, for a maximum of 10 days. Data on clinical outcomes (e.g. duration of mechanical~     ventilation, PICU stay, hospital stay, acquired infections) will be collected up to 60 days~     after admission to the PICU. The main objective of the study is to examine the association~     between energy and protein intake adequacy (in relation to the prescribed goals for these~     nutrients) and 60-day mortality in mechanically ventilated children.~   "
92644|NCT02354508|"~     This is a phase IIIb multicenter, open-label; single arm study to evaluate the efficacy and~     safety of pasireotide LAR 40 mg and 60 mg in patients with inadequately controlled acromegaly~     with maximal approved doses of first generation somatostatin analogues. The study will enroll~     inadequately controlled patients by high doses (maximal approved) of first-generation~     somatostatin analogues given for at least 3 months. Patients will receive pasireotide LAR 40~     mg or 60 mg during the 36 week core study phase. Patients who have completed all visits of~     core phase and have completed all the assessments at the core phase completion visit can move~     into the 32-week extension phase. Patients can continue with study treatment until~     pasireotide LAR is commercially available and reimbursed in their respective country or until~     the end of the extension phase whichever occurs first.~   "
92645|NCT02354495|"~     The investigators aim to examine the feasibility of individualized diet intervention in~     children dependent on long-term mechanical ventilator support at home. The investigators will~     use a multidisciplinary model that will allow for diet modification based on comprehensive~     nutrition, metabolic and respiratory assessments performed in the subjects' home. the impact~     of this intervention (for 12 weeks) on body composition and respiratory variables will be~     assessed.~   "
92646|NCT02354482|"~     Funded by the Patient Centered Outcome Research Institute (PCORI), nationally recognized~     leaders in health care and research methods are partnering with patients and caregivers to~     evaluate the effectiveness of current efforts at improving care transitions and develop~     recommendations on best practices for patient-centered care transitions and guidance for~     spreading them across the U.S.~   "
92647|NCT02354469|"~     Recently, researchers and clinicians have examined many different forms of concussion testing~     aimed to assess if a brain injury has occurred and to what degree it affects the individual~     being tested. Due to the multifaceted and complex presentation of concussive injuries and the~     unknown effects of repeated head trauma, it is unlikely that a single test of physiological~     or behavioral function will reflect the full range of injury-related damages from a~     concussive event or from a series of cumulative head traumas, as well as the injury response~     within brain tissue. However, by combining a variety of objective assessments which may~     detect structural and functional alterations following head trauma into a single study, a~     clearer understanding of the multi-faceted presentation resulting from head trauma may be~     identified. The identification of biomarkers and the utilization of objective and clinically~     feasible tools will provide a method to assess three domains across multiple systems affected~     by head trauma: 1) the prognostic value of initial concussion assessments to identify injury~     severity and factors responsible for prolonged recovery, 2) the temporal window of recovery~     and potential vulnerability of brain tissue post-injury, and 3) the long-term alterations~     associated with repeated head trauma exposure.~   "
92648|NCT02354456|"~     Atrial fibrillation (AF) is one of the most common cause of preventable ischemic stroke and~     associated with increased cardiovascular morbidity and mortality. Our previous AFTER study~     demonstrated the general epidemiological data about the patients with valvular and~     nonvalvular AF in Turkey. However, data is lacking about the use of new oral anticoagulants~     (NOACs), time in therapeutic INR range (TTR) in vitamin K antagonist users and AF management~     modality in our country. In this multicenter trial the investigators aimed to analyze, follow~     and evaluate the epidemiological data in non-valvular AF patients.~   "
92649|NCT02354443|"~     The purpose of this study is to describe the safety profile of ProHema-CB as part of a single~     cord blood unit transplant after a myeloablative conditioning regimen in pediatric patients~     with inherited metabolic disorders. The safety profile will primarily be assessed by~     neutrophil engraftment.~   "
92650|NCT02354430|"~     To investigate the possible effect of an unsupervised water-exercise program, on the~     intensity of low back pain and the number of days spent on sick leave, among healthy pregnant~     women Our hypothesis is, that 45 minutes of water exercise twice a week for a period of 12~     weeks during pregnancy, will reduce the intensity of low back pain and the days spent on sick~     leave.~   "
92651|NCT02354417|"~     This is an open-label, safety study of a single ProHema-CB product administered following~     myeloablative conditioning regimen in pediatric subjects with hematologic malignancies.~   "
92652|NCT02354404|"~     Phase Ib study in 90 healthy adults,18 years to 65 years of age, to evaluate the safety,~     tolerability and immunogenicity of the VRC-EBOADC069-00-VP (cAd3-EBO) and VRC-EBOADC076-00-VP~     (cAd3-EBOZ) investigational Ebola vaccines in Part 1 and boosting with the~     VRC-EBOMVA079-00-VP (MVA-EbolaZ) investigational Ebola vaccine in Part 2.~      Part 1: Randomizations to cAd3-EBO or cAd3-EBOZ at two different dose levels within Group 1~     will include at least 60 volunteers who have never received an investigational Ebola vaccine.~     Randomizations to cAd3-EBO at two different dose levels within Group 2 may include up to 30~     eligible participants who previously participated in the RV247 vaccine clinical trial and~     received the investigational VRC-EBODNA023-00-VP (Ebola DNA WT) vaccine.~      Part 2: Participants in Part 1 may receive a booster vaccination with the MVA-EbolaZ vaccine~     at the same dose level.~   "
92653|NCT02354391|"~     The objective of this study is to determine the efficacy, safety, and patient satisfaction of~     pretreatment with Picato® gel 4 days prior to methyl aminolevulinate photodynamic therapy~     (MAL PDT). Patients diagnosed with actinic keratosis who are eligible to receive topical~     treatment with ingenol mebutate (Picato®) and photodynamic therapy will act both as the test~     group and the control group. Each patient will have four distinct treatment areas of 25cm2 on~     the scalp, and/or scalp and face. Three of the treatment areas will receive Picato® 0.015%~     gel, MAL PDT, or Picato® 0.015% and MAL PDT combined. One area will serve as a control and~     will receive none of the treatments.~   "
92654|NCT02354378|"~     The goal of this study is to determine the effects of dexmedetomidine on memory and recall of~     children who are receiving dexmedetomidine sedation administered for magnetic resonance~     imaging (MRI) studies. Dexmedetomidine is currently the standard drug for sedation for~     diagnostic (MRI, computerized tomography (CT) and Nuclear Medicine) radiological studies at~     Boston Children's Hospital (BCH). The effect of dexmedetomidine on memory and recall in~     children has not been studied.~   "
92655|NCT02354365|"~     Typically doctors adjust the settings on the ventilator to ensure that children receive~     enough help to decrease the work they perform to breathe, receive enough oxygen through the~     machine to pass into the blood and to the organs, and remove acid that builds up in the~     blood. However, sometimes the settings we choose can result in damage to the lungs. We are~     trying to find a better way to determine the best ventilator settings, which can minimize~     potential damage to the lungs, and still provide children with enough support to decrease the~     work they have to do to breathe. We believe we can personalize these choices for each child~     by looking at the pressure that is generated in the chest while children breathe with the~     ventilator. This is accomplished by using a small tube which goes through the nose and into~     the esophagus or stomach, which is hooked up to a computer or the ventilator to monitor~     pressure. This same tube can then also be used to monitor how much work children need to do~     to breathe as we are turning down the ventilator in preparation to remove the breathing tube.~   "
92656|NCT02354352|"~     The study is to demonstrate non-inferiority of spironolactone vs. eplerenone in preserving~     cardiac and pulmonary function in patients with preserved LV ejection fraction. Males with~     Duchenne muscular dystrophy (DMD) confirmed clinically and by mutation analysis will be~     enrolled. Subjects will be randomized to either eplerenone or spironolactone. Subjects will~     use a drug diary to record daily compliance of taking the study medication as well as any~     concerns they may have during the study period. Subjects will undergo cardiac magnetic~     resonance imaging (CMR) and pulmonary function tests (PFT) at baseline and then again at 12~     months post enrollment. Subjects will also complete a quality of life questionnaire at~     baseline and 12 months. Degree of elbow contracture will be measured using a goniometer at~     baseline and 12 months.~   "
92657|NCT02354339|"~     The metabolic syndrome is a high prevalence disease worldwide. About a quarter of the adult~     population suffers from the disease and predispose the onset of diseases like cardiovascular~     disease and diabetes mellitus type 2.~      The first line of treatment for metabolic syndrome is diet and exercise but patients have a~     low attachment to the treatment, so pharmacologic therapy is required. There is no a single~     drug that could help to the treatment of all metabolic syndrome components.~      Irvingia gabonensis, better known as African mango, is widely consumed in central and western~     Africa, mainly the fruit and seeds. Besides being part of the diet of African the seeds have~     been used for the treatment of diseases such as dysentery, diabetes and as an analgesic.~      Resent investigations have demonstrated that an extract of African mango seeds induce~     significantly weight loss in subjects with obesity, and also improves some biochemical~     parameters such as glucose and the lipid profile.~      The aim of this study is to evaluate the effect of Irvingia gabonensis on metabolic syndrome,~     insulin secretion and insulin sensitivity.~   "
92658|NCT02354326|"~     This clinical trial studies dual energy computed tomography (CT) in finding cancer that has~     spread from the original (primary) tumor to the bone (bone metastases) in patients with~     cancer. Diagnostic procedures, such as dual energy CT, may help find and diagnose bone~     metastases and may be more accurate compared to single energy CT alone.~   "
92659|NCT02354313|"~     A phase III multicenter, randomized study with Lenalidomide (Revlimid®) maintenance versus~     observation after intensified induction regimen containing rituximab followed by high dose~     chemotherapy and Autologous Stem Cell Transplantation as first line treatment in adult~     patients with advanced Mantle Cell Lymphoma: IIL study (MCL0208).~   "
92660|NCT02354300|"~     Flow diverters have been approved since 2012 for the treatment of large, wide neck~     intracranial aneurysms. These devices have been associated with embolic events which cause~     blockage in a blood vessel and can result in long term complications. One possible cause of~     these events is the formation of small emboli during placement of the device.~   "
92661|NCT02354287|"~     There is no consensus method for removal of diminutive (5mm) to small(6-9mm) colorectal~     polyps at colonoscopy. Neither the European Society of Gastrointestinal Endoscopy or the~     American Society of Gastrointestinal Endoscopy have guidelines for the removal of these~     polyps, despite the fact that around 90% of lesions removed by polypectomy at colonoscopy are~     diminutive to small.~      Multiple techniques are used for polyp removal, especially diminutive lesions. These include~     either forceps, both hot and cold, as well as snare with electrocautery or cold snare.~     Forceps utilises shearing force to grasp tissue and remove it, with the hot method passing a~     current through the grasper to essentially burn tissue. Snare is the use of a small metal~     loop placed and tightened at the base of polyps to cut through the tissue either straight~     away in a cold method or with electrocautery where a small current is passed through the loop~     to assist cutting through tissue. Surveys of Colonoscopists and Gastroenterologists in~     Australia and the United States show that the choice of method used for diminutive to small~     polyps is highly variable with cold snaring marginally favoured.Studies into polypectomy~     techniques are limited and it is clear that additional data and the review of polypectomy~     methods needs to be undertaken in order determine the optimal method for the removal of~     diminutive and small colorectal polyps.~      A technique is used at the Gloucestershire National Health Service (NHS) trust involving a~     submucosal pre injection with a standard solution then the use of cold forceps for removal of~     polyps ≤7mm. This appears to be both very safe and highly effective method for the removal of~     these lesions compared to other techniques. No formal published studies have been completed~     to evaluate this method at national and international levels. We propose a study to evaluate~     the effectiveness, safety and costs of this method.~   "
92662|NCT02354274|"~     To investigate the effect of escalation of radiation dose to tumor and lymph nodes based on~     an inhomogeneous dose distribution controlled by FDG-PET positive areas compared to a~     standard homogeneous dose spread~   "
92663|NCT02354261|"~     The study will assess the safety and efficacy of SUBA-Cap in subjects with Basal Cell~     Carcinoma Nevus Syndrome.~   "
96368|NCT02305771|"~     The aim of the study is to demonstrate that our semantic knowledge (elements of our long-term~     memory and the process we use them) respond to a graphic organisation and gather together~     following accurate patterns called cliques (neural networks).~   "
92664|NCT02354248|"~     TST (Triple stimulation technique) helps to better quantify the proportion of motor units~     activated by transcranial magnetic stimulation. The abnormal amplitude registered by TST is~     proportional to the intensity of conduction disorders. The evaluation of these disorders is~     more precise with this technique than with the slowing of the central conduction time (CCT).~      The investigators propose to use this technique in CNS pathologies where this disorder is~     significant and essential, like multiple sclerosis and stroke.~   "
92665|NCT02354235|"~     The purpose of this study is to evaluate the efficacy and safety of co-administration of~     Teneligliptin (MP-513) and Canagliflozin (TA-7284) once daily for 24 weeks in Japanese~     patients with Type 2 diabetes mellitus who are receiving treatment with Teneligliptin and~     have inadequate glycemic control.~   "
92666|NCT02354222|"~     The purpose of this study is to evaluate the efficacy and safety of co-administration of~     Canagliflozin (TA-7284) and Teneligliptin (MP-513) once daily for 24 weeks in Japanese~     patients with Type 2 diabetes mellitus who are receiving treatment with Canagliflozin and~     have inadequate glycemic control.~   "
92667|NCT02354209|"~     The purpose of the study is to look at possible reasons why some HIV positive people who take~     their drugs properly and have no resistance to these drugs, still have low amounts of virus~     detectable in their blood. This is known as Low Level Viraemia (LLV). When low levels of HIV~     virus are present, some can mutate and make the drugs less effective (i.e. some variants of~     the virus become more resistant). Currently, however, these resistance mutations may be~     difficult to detect using standard tests for resistance because the amount of virus in the~     blood is very low and the standard tests aren't sensitive enough to pick up the mutations.~     The investigators will use more sensitive mutation detection methods, known as Next~     Generation Sequencing (NGS), to look at whether see if there are any low levels of drug~     resistant HIV virus developing in the blood when LLV occurs. The investigators will look at~     the different treatment strategies that are used in routine standard practice when LLV is~     detected and evaluate which is most effective in preventing development of resistance. The~     investigators hope this research will help to inform guidelines on the best way to treat HIV~     in the future.~   "
92668|NCT02354196|"~     To determine the total plaque burden, plaque severity and composition of patients undergoing~     Cardiac CT who do not have any previous history of CVD. There are two cohorts:~        1. A retrospective follow-up for MACE endpoints of patients who underwent a CCTA >1 year~          ago as part of the Big PICTURE Trial, who meet the inclusion criteria of Big PICTURE 2.~        2. A prospective observational registry of patients referred to undergo CCTA with a 1 and 2~          year follow-up.~   "
92669|NCT02354183|"~     Research suggests that individuals with Borderline Personality Disorder (BPD) experience low~     motivation for change (Skodal, Buckley, & Charles, 1983). Dialectical Behavior Therapy (DBT;~     Linehan, 1993) includes commitment strategies that are designed to improve motivation. No~     studies have examined the effectiveness of these strategies. The proposed study will evaluate~     the efficacy of a brief DBT intervention consisting of commitment strategies plus skills~     training for people who self-harm. Participants will be randomly assigned to either a single~     orientation session of (1) commitment strategies plus psychoeducation or (2) psychoeducation.~     Immediately following their orientation session, all participants will be enrolled in a 90~     minute group skills training session. Primary outcomes include autonomous motivation and~     frequency of self harm behaviours. Assessments will be conducted at six time points:~     baseline, after the initial orientation session, after the skills training group session, and~     at one week, one month, and three month follow-up~   "
92670|NCT02354170|"~     The goal of the study is to assess the efficacy and safety of mifepristone 300 or 900-mg~     once-daily dosing by mouth for 4 weeks in patients with central serous chorioretinopathy.~   "
92671|NCT02354157|"~     Control rules are common parental practices that use food as reward to encourage children to~     conduct parents' preferred behaviors. This field observational study aims to examine whether~     control rules are associated with children's increased fat, carbohydrate and total energy~     intake in everyday eating, and whether this effect is moderated by individual differences in~     sensitivity to reward, and by gender differences.~   "
92672|NCT02354144|"~     The LIMIT-Study is a placebo-controlled, double-blinded randomized controlled trial designed~     to explore the efficacy of a carrageenan-based lubricant as a topical microbicide for~     preventing HPV acquisition. Individuals at high risk for infection (men who have sex with~     men, or MSM, and especially those with HIV) will be included in the trial. Participants will~     complete a self-administered baseline questionnaire during the enrolment visit, and follow-up~     questionnaires during all other six visits. The shorter follow-up questionnaires are intended~     to evaluate recent sexual behaviours and to corroborate the responses given during the~     baseline visit. These questionnaires will measure HPV risk factors, compliance, and monitor~     safety and tolerability of the gels. Between follow-up visits, participants will be asked to~     log into a secure web module at least once a week to answer questions on daily sexual~     activities, condom and study gel use, and adverse evens. Individuals will be screened for~     eligibility over the telephone or in person and eligible men will attend an enrolment visit,~     where the nurse will obtain informed consent and instruct the participant on gel use. They~     will receive a one month's supply of gel and provide the first specimen. Random number sets~     will be assigned to the treatment and control gel. Each participant will be assigned an~     individual code, which will be used to match him to the study arm. Lastly, the nurse will~     provide details about HPV infection and advice about condom use and sexual health. HPV~     infection status will be measured using anal specimens at baseline (enrolment/time 0), and at~     all follow-up clinic visits (1, 2, 3, 6, 9 and 12 months).~   "
92673|NCT02354131|"~     Part 1 (Phase 1): safety and tolerability of bevacizumab-Niraparib combination Part 2~     (Randomized Phase 2): to compare Progression-Free Survival (PFS)~      PARP inhibitors are active as monotherapy to treat patients with recurrent ovarian cancer;~     the strongest activity being observed in the platinum sensitive, gBRCAmut subgroup as well as~     in gBRCAwt, HRD population but also in HRD negative disease.~      In the same population there is level one evidence that bevacizumab is beneficial. And a~     phase two randomized study has indicated that combination of a PARP inhibitor with~     anti-angiogenic drug is superior to PARP inhibitor alone.~      The question is:~      Is niraparib combined with bevacizumab superior to niraparib? The comparison of tolerability~     and efficacy of niraparib-bevacizumab combination against niraparib.~   "
92674|NCT02354118|"~     The purpose of this study is to determine the safest and most effective flushing solution for~     maintaining patency (unobstructed flow) in implanted port catheters. The complication rate in~     patients whose ports are flushed with saline only will be compared to the complication rate~     in patients whose ports are flushed with a combination of saline and heparinized saline.~   "
92675|NCT02354105|"~     The primary purpose is to assess the effectiveness of certolizumab pegol in patients with~     axial spondyloarthritis under routine clinical practice.~   "
92676|NCT02354092|"~     Cervical dilators are frequently used for preparation prior to second trimester surgical~     abortion. While their use decreases complications associated with surgical abortion, their~     placement is often uncomfortable for the patient. Currently there are no proven methods for~     reducing pain during osmotic dilator placement. The use of numbing medication around the~     cervix (paracervical block) may decrease this placement pain.~   "
92677|NCT02354079|"~     The aim of this study is to identify new targets in cholesterol metabolism thanks to a~     genetically-based strategy.~   "
92678|NCT02354066|"~     Patients often seek advice from their treating doctor if they are able to drive with a foot~     orthosis after a first metatarsal osteotomy for symptomatic hallux valgus and/or after an~     additional forefoot surgery. This challenging question is of obvious importance for the~     patient and other road users. Previous studies already issued driving ability after different~     orthopedic procedures and with knee and ankle devices on the brake reaction time but missed~     to address the same for foot orthoses after hallux valgus or forefoot surgery.~      This missing evidence made us evaluate the influence of wearing a foot orthosis after a first~     metatarsal osteotomy or forefoot surgery on driving ability (brake response time; BRT).~      The overall time frame is about nine weeks; each appointment for BRT measurement takes about~     fifteen to twenty minutes. The first BRT measurement is one day before the foot surgery~     without a foot orthosis (normal shoe)and with the orthoses (control run) (1) at two days (2),~     two weeks (3), four weeks (4) and six weeks (5) after the operation with a HVS and a FRS and~     eight weeks postoperative without a foot orthoses (6).~   "
92679|NCT02354053|"~     Modern antiretroviral therapeutic regimens offer a vast array of choice that permits tailored~     therapy for HIV patients. While modern regimens have improved the rates of virologic~     suppression overall and reduced adverse effects of antiretroviral treatment, an important~     sub-group of HIV infected persons is unable to maintain adherence to their treatment~     regimens, fail to achieve long term virologic control and remain at risk for HIV related~     disease progression and transmission of HIV infection.~      Hypothesis: switching from current cART regimen to a Triumeq based regimen combined with~     adherence support will improve the rate of HIV suppression in vulnerable populations~     non-adherent to the their current cART as determined by the achievement of HIV-1 RNA < 50~     copies/mL at Week 24 post randomization.~   "
92680|NCT02354040|"~     Although most patients admitted with acute coronary syndrome or acute ischemic stroke in~     South Asian countries receive these evidence-based treatments, their overall continuation in~     the outpatient phase of care remains low. Patient from Pakistan are uniquely challenged in~     this respect because the overall literacy rates remain one of the lowest in Pakistan among~     South Asian Countries. In addition, a great majority of Pakistani patients often do not~     understand or follow health prescriptions (which are still written in English). Additionally,~     due to an unregulated health industry, they frequently take multiple opinions and~     prescriptions from different physicians. The investigators propose to develop a talking~     prescription for patients with stroke or myocardial infarction for secondary prevention.~     This will enable them to understand their medications better, improve health literacy and~     adherence. This is an IT enabled health literacy intervention. Physicians will prescribe~     statin and/or antiplatelet to the selected patients and enter the necessary details on an~     Optical Mark Recognition (OMR) sheet.Patients will be assigned to either of the 2~     arms--either regular care or talking prescriptions. Follow-up will be done at 3 months post~     recruitment for behavioral knowledge assessment and adherence assessment.~   "
92681|NCT02354027|"~     The purpose of the study is to investigate the potential interaction between multiple oral~     doses of SHR3824 and a single oral dose of metformin in healthy adult volunteers.~   "
92682|NCT02354014|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (explores~     what the body does to the drug), and anti-mycobacterial activity of bedaquiline (TMC207) in~     children and adolescents (0 months to less than [<] 18 years of age) diagnosed with confirmed~     or probable pulmonary multidrug resistant tuberculosis (MDR-TB), in combination With a~     Background Regimen (BR) of MDR-TB Medications.~   "
92683|NCT02354001|"~     The aim of the project is to investigate the use of Raloxifene (a new form of estrogen) in~     the treatment of young women with schizophrenia and schizoaffective disorder. Raloxifene is a~     Selective Estrogen Receptor Modulator (SERM),which means that it can affect the central~     nervous system (CNS) effects of estrogen (eg. improving emotional symptoms, memory,~     information processing and concentration), without adversely affecting reproductive~     tissue/organs such as breast, uterus and ovaries. The investigators are conducting a~     double-blind, placebo controlled, three month study comparing the psychotic symptom response~     of women with schizophrenia in both groups. One group will receive standard antipsychotic~     medication plus 120mg Raloxifene, while the second group will receive standard antipsychotic~     medication plus oral placebo.~   "
92684|NCT02353988|"~     Growing studies demonstrated that Androgen Receptor (AR) has an oncogenic role for the~     patients with AR-positive Triple Negative Breast Cancer (TNBC). AR antagonists in therapy,~     such as bicalutamide, completely binds to the AR, increasing AR degradation, thus are~     investigated for the efficacy of the treatment of patients with AR-positive TNBC in the~     study.~   "
92685|NCT02353975|"~     This open-label, randomized, two-period, two-treatment (single doses of 10 mg SHR3824 fasted~     or fed), crossover study was conducted to evaluate the effect of a high-fat meal on the~     pharmacokinetics of SHR3824 and mass balance study in 12 healthy subjects.~   "
92686|NCT02353962|"~     The aim of this study is to evaluate the feasibility and usability of newly developed~     exergames on exploring the hemineglected space of left neglected stroke patients. Furthermore~     to understand the experience of living with visuospatial neglect and to explore the users'~     experiences (patients and clinic staff) with those new exergames.~   "
92687|NCT02353949|"~     The study examines subjects where there might be an indication for Amyloid-PET according to~     the Criteria defined by the Amyloid Imaging Task Force. In these subjects the impact of a~     Flutemetamol (Vizamyl)-Positron-Emission-Tomography -Scan (PET) on clinical management and~     disease course will be studied over 6 months.~   "
92688|NCT02353936|"~     As a 2nd generation EGFR-TKI that irreversibly binds to EGFR receptors, afatinib showed the~     possibility of superior effects to 1st generation TKIs such as erlotinib and gefitinib. In a~     phase III study LUX-lung 3 in patients with EGFR mutation-positive non-small-cell lung~     cancer, afatinib monotherapy showed longer progression-free disease survival time of 11.1~     months than that (6.9 months) of pemetrexed/cisplatin combination therapy. Based on such the~     results, it is currently recommended as the standard first-line treatment for EGFR~     mutation-positive lung cancer, and clinical studies are also being actively conducted in~     other types of carcinomas characterized by EGFR gene mutation and overexpression. Thirty (30)~     solid cancer patients were included in a phase I trial of afatinib, and of them, a patient~     with esophageal cancer had partial response. Taken together, based upon the results from~     clinical trials of afatinib conducted so far, 7 out of 15 esophageal cancer patients achieved~     clinical responses of 3 months or longer.~      Hence, the overall results from previous studies of gefitinib and erlotinib as EGFR TKIs and~     our study of dacomitinib, as well as from preceding studies of afatinib - a 2nd generation~     EGFR TKI - suggest the possibility of an effective therapy in esophageal cancer characterized~     by well-known EGFR overexpression. In this phase II trial, afatinib shall be administered to~     patients with squamous cell carcinoma of esophagus to evaluate its effects and toxicity.~     Also, biomarkers to predict responses to afatinib shall be explored through further studies.~   "
92689|NCT02353923|"~     The purpose of this study is to determine whether supplementation with OcuStem, a nutritional~     supplement, will reduce the progression of mild to moderate diabetic retinopathy.~   "
92690|NCT02353910|"~     Prospective studies on the incidence of VTE during severe sepsis and septic shock remain~     absent, hindering efficacy assessments regarding current VTE prevention strategies in septic~     patients. The investigators will prospectively study consecutively enrolled ICU patients with~     severe sepsis and septic shock admitted at three hospitals. All patients will provide~     informed consent and the study will be IRB approved. VTE thromboprophylaxis, provided per~     standard of care and according to the patients' primary team, will be recorded for all~     patients. Patients will undergo bilateral lower (and upper, if a central venous catheter~     [CVC] was present) comprehensive compression ultrasonography (CUS) and will be followed for~     symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE) prior to discharge. The~     investigators will perform multivariate regression analyses to identify predictors of VTE.~   "
92691|NCT02353897|"~     This study aims to look at patient and physician satisfaction of long term Glabellar lines~     (GL) treatment with Dysport in a real life setting. It will also allow better understanding~     of what patients expect from the treatment, and the injection practices used by doctors.~   "
92692|NCT02353884|"~     The purpose of this study is to find the characteristics of mild cognitive impairment (MCI)~     using technology of Multi-Modality MRI , including structural MRI, functional MRI and~     diffusion tensor imaging(DTI). Then analyze the difference between progressive MCI (MCIp) and~     stable MCI (MCIs) and further construct the predictable classifier from MCI to Alzheimer's~     disease (AD) based on Multi-Modality MRI characteristics of MCI patients.~   "
92693|NCT02353871|"~     The purpose of this study was to demonstrate the safety and the efficacy of a single~     treatment of an injectable liquid form of Clostridium botulinum toxin type A haemagglutinin~     complex (BTX-A-HAC; hereafter referred to as BTX-A-HAC Next Generation (BTX-A-HAC NG)), used~     for the improvement in the appearance of moderate to severe glabellar lines (the lines~     between the eyebrows).~   "
92694|NCT02353858|"~     The current trial is evaluating the impact of deep regional hyperthermia on the pathological~     complete response rate in locally advanced rectal cancer in the context of preoperative 5FU~     based radiochemotherapy.~   "
92695|NCT02353845|"~     One purpose of this study is to construct the diagnosis system for early Alzheimer's~     disease(AD), which is also called amnestic mild cognitive impairment (aMCI), and then further~     construct the predictable classifier from aMCI to AD based on Multi-Modality MRI~     characteristics of aMCI patients.~   "
92696|NCT02353832|"~     The purpose is to determine if use of rectal spacers are effective at improving protection of~     rectum from high dose radiation, using rate of rectal ulceration as a surrogate measure of~     acute effects. It is also to determine whether it provides sufficient dosimetric benefits to~     warrant further clinical investigation in future SABR (Stereotactic Ablative Body Radiation)~     related clinical studies.~   "
92697|NCT02353819|"~     Since high risk prostate cancer requires higher radiation, this study is being done to~     determine the maximum tolerated dose of radiation to the prostate and pelvic regions. Also to~     determine the feasibility and safety of each treatment fraction by using cone-beam Computed~     Tomography(CT) information and high speed Graphics Processing Unit based computation~     treatment planning systems. We also plan to determine the safety of treatment to the~     prostate. Health-related quality of life will be measured as part of current clinical~     practice.~        -  Determine the maximum tolerated dose (MTD) or to safely escalate dose to the pelvic~          nodal using 90 day acute toxicity endpoint~        -  Determine feasibility and safety of adaptive real time re-planning of the pelvic nodal~          region at each treatment fraction by using cone-beam CT (CBCT) information and high~          speed GPU based computation treatment planning systems~        -  Determine the safety and tolerability of 9.5 Gy per fraction in five fractions (47.5 Gy~          total dose) to the prostate~        -  To follow tumor related outcomes (i.e. PSA control, progression-free survival (PFS),~          distant metastasis (DM) free survival, and overall survival (OS)~        -  Health-related quality of life (HRQOL) will be measured as part of current clinical~          practice Patients in each dose cohort will all be treated as a single group for dose~          escalation. There will be two levels of dose escalation—to prostate lesions and to~          pelvic lymph node region. Prostate/SV PTV will be treated at a fixed dose of 9.5 Gy per~          fraction for 5 fractions (47.5 Gy) based on our previous phase I/II study experiences.~          The starting dose for the dose escalation to the pelvic region PTV will be 4.5 Gy per~          fraction for 5 fractions (total dose= 22.5 Gy). Subsequent cohorts of patients will~          receive an additional 0.5 Gy per treatment (total 2.5 Gy per escalation). The starting~          dose for MRI-visible prostatic lesions will be 10 Gy and subsequent cohorts will receive~          an additional 0.5Gy per treatment (total of 2.5Gy per escalation).~   "
92698|NCT02353806|"~     This is a phase IV prospective trial to collect and analyze information about the maternal~     pharmacokinetics of amlodipine besylate at the time of delivery and during postpartum~     lactation. The study will also evaluate amlodipine concentrations in the infants of~     breastfeeding mothers who are taking amlodipine besylate for treatment chronic hypertension.~   "
92699|NCT02353793|"~     Hypothermia is a common problem in traumatized patients leading to severe complications such~     as impaired coagulation, increased rate of wound infections and overall patient discomfort~     among others. Therefore, the investigators test out the new self warming ReadyHeat® blanket~     device against the currently used cotton wool blanket in terms of effects on the prevention~     and treatment of hypothermia.~   "
92700|NCT02353780|"~     An Agency for Healthcare Research and Quality executive summary indicated that better~     comparative effectiveness trial designs are needed to determine the relative merits of~     existing versus new and expensive biologic drug therapies for rheumatoid arthritis (RA).~     There are now 9 biologic therapies approved for treating RA. Four classes of biologics (TNF~     antagonists, B-cell inhibitors, T-cell co-stimulator blocker, and Interleukin-6 receptor~     blocker) are approved for use in RA patients with moderate or severe disease activity.~     Several critical questions have arisen, such as 1) what therapy should be prescribed after~     failure of methotrexate and/or other oral disease modifying antirheumatic drugs (DMARDs) to~     adequately control disease activity; 2) what is the level of efficacy of the various biologic~     therapies when compared in head-to-head trials; and 3) what are the mechanisms associated~     with failure of methotrexate and/or other oral DMARD therapy and responsiveness to biologic~     therapies. The MAZERATI study will provide the foundation for answering these questions and~     determining the mechanisms associated with these biologic therapies.~   "
92701|NCT02353767|"~     This study aims to estimate the prevalence of bridging liver fibrosis and cirrhosis (METAVIR~     score ≥ F2) according to METAVIR score in HIV infected patients not chronically infected by~     viral hepatitis but exhibiting a metabolic syndrome according to the IDF definition~     (International Diabetes Foundation).~   "
92702|NCT02353754|"~     This is a Phase 4, multicenter, open-label study evaluating EXPAREL infiltration into the~     transversus abdominis plane (TAP) after bupivacaine hydrochloride (HCl) spinal anesthesia in~     subjects undergoing elective Cesarean section (C-section).~   "
92703|NCT02353741|"~     This single-arm phase II study aims to study the efficacy of a possible first line treatment~     that combines epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKIs) with~     concurrent thoracic radiation therapy for stage IV non-small cell lung cancer (NSCLC) with~     active EGFR mutation, as well as assessing PFS, OS, tumor response, etc. to verify that this~     new combinational therapy can benefit short-term and long-term survival of the patients with~     advanced NSCLC.~   "
92704|NCT02353728|"~     The study is an open-label phase 2 clinical and translational trial designed to evaluate the~     effects of nilotinib on the leukemic stem cell population in subjects with newly diagnosed~     chronic phase chronic myeloid leukemia (Ph+ CML in CP). Nilotinib is FDA-approved to treat~     subjects with Ph+ CML in CP. Subjects on study will be monitored according to accepted~     National Cancer Comprehensive Network [NCCN] clinical guidelines for 24 months. After 24~     months, if continued therapy is needed subjects will be transitioned to commercial supply of~     study drug.~   "
92705|NCT02353715|"~     This is a pilot exercise physiology and quality of life study of subjects receiving standard~     of care therapy for their prostate cancer using FDA-approved drugs per their labeling~     (abiraterone, enzalutamide, or sipuleucel-T). Subjects with progressive, asymptomatic or~     minimally symptomatic mCRPC scheduled to be treated with either enzalutamide or abiraterone~     acetate for ≥3 months or a course of sipuleucel-T will be allocated to one of the treatments~     arms, according to the treatment chosen by the treating physician.~   "
92706|NCT02353702|"~     Upper abdominal surgery is known to induce such pulmonary complications as pneumonia,~     atelectasis, pleural effusion. The post operative diaphragmatic dysfunction participates to~     these complications and lasts for 7 days after upper abdominal surgery. The sniff-test is a~     recognized tool for measuring the diaphragmatic function.The purpose of this study is to~     evaluate the effectiveness of parietal analgesia with continuous infiltration of local~     anesthesic on diaphragmatic function after upper abdominal surgery through a subcostal~     incision. Our main outcome is to measure the diaphragmatic function with the sniff test in 44~     patients with parietal infiltration of ropivacaine and in 44 patients with placebo. Our~     secondary outcomes are the evaluation of the effect of continuous parietal analgesia with~     ropivacaine on IPmax and EPmax, oxygen saturation, post operative pulmonary complications and~     post operative recovery. This prospective study will determine if the pre peritoneal local~     infiltration of ropivacaine is useful to decrease post operative diaphragmatic dysfunction.~   "
92707|NCT02353689|"~     This study aimed to investigate the effects of FODMAP contents in enteral nutrition (EN)~     formulas on major gastrointestinal intolerance symptoms and nutritional status in tube fed~     patients through the randomized, double blind and placebo-controlled trial.~   "
92708|NCT02353676|"~     Control of postoperative pain is a foremost goal in achieving a satisfactory postoperative~     recovery. Surgical removal of lower third molars is accompanied by postoperative pain that is~     at its peak in the first 12 hours. Our study evaluates if the use of 2% lidocaine~     hydrochloride for the surgical removal of lower third molars with a postoperative 0.5%~     bupivacaine supplementation would result in lesser postoperative pain and a decrease in~     ingestion of oral analgesics to control the pain when compared to a placebo.~   "
92709|NCT02353663|"~     Rheumatic heart disease remains a major challenge in low and middle income countries. Early~     detection of clinically silent valvular lesions by screening echocardiography allows timely~     implementation of secondary antibiotic prevention, and may prevent progression of disease to~     severe valvular damage and heart failure. The objective of the study is to assess the~     prevalence of rheumatic heart disease among schoolchildren in Arequipa, Peru. Subsequently,~     the investigators will evaluate progression of disease in children with early stages of~     subclinical rheumatic heart disease.~      The investigators will perform a population-based observational survey for rheumatic heart~     disease using portable echocardiography among schoolchildren aged 5 to 16 years from randomly~     selected public and private schools. Rheumatic heart disease will be documented both~     according to the modified World Health Organization definition and the echocardiographic~     criteria suggested by the World Heart Federation.~   "
92710|NCT02353650|"~     The study is a randomised double-blinded trial. A group of 40 tinnitus patients with a~     naturally low Q10 level will be selected out of a preselected group of 160 screened out of a~     pre-existed database or patients which visited the ENT-consultation. The 40 patients with the~     lowest level will be asked to take 2 months Q10 (n=20) or the placebo (n=20). To evaluate the~     effect on hearing and tinnitus characteristic; audiometric test, tinnitus analysis and~     auditory evoked responses will be used as outcome measurements.~   "
92711|NCT02353637|"~     The aim of the study is to investigate, in severely obese adolescents, the effects of a high~     protein, restricted carbohydrates utilizing partial meal replacements diet (HPRC-PMR) on~     weight loss, body composition, and bio-chemical markers of lipid metabolism, insulin~     resistance, and inflammation over a 12 months period.~   "
92713|NCT02353611|"~     Bleaching protocol In each session, volunteers received prophylaxis with pumice powder and~     water. Then, gingival tissue was protected using a light-cured resin gum barrier applied~     according to the manufacturer's instructions (Lase Protect - DMC, São Carlos, SP, Brazil).~     Both bleaching agents were prepared by mixing hydrogen peroxide and thickening compounds~     according to the manufacturer's instructions (with 3 peroxide drops for 1 drop of thickener).~     The resultant gels were distributed uniformly on the upper hemiarcade surfaces of the teeth.~     A total of 8 teeth between the first premolars were bleached for each patient. In each~     bleaching session, the bleaching gels were applied twice for 12 minutes each. In each~     application, the surface of the gel was light activated with continuous irradiance for 12~     minutes using LED/laser light with a total power of 1800 mW (Whitening Lase Plus - DMC~     Equipamentos, São Carlos, SP, Brazil). Three bleaching sessions were completed for the~     patients, and the interval between sessions was 7 days~   "
92714|NCT02353598|"~     This randomized, placebo-controlled, double-blind, parallel-arm study will evaluate the~     safety and tolerability of at least two dose levels of intravenous (IV) crenezumab in 24-72~     participants with mild to moderate Alzheimer disease (AD) (mini-mental state examination~     [MMSE] 18 to 28 points, inclusive). An optional open-label extension (OLE) will be offered~     after the completion of initial double-blind stage.~   "
92715|NCT02353585|"~     The present study will monitor and explore acute neurovascular emergencies in patients~     treated with NOACs compared to those under treatment with VKAs. The primary aims of this~     study are: (1) To investigate characteristics, management and outcome of intracranial~     hemorrhage (ICH) in patients treated with NOAC compared to VKA. (2) To investigate the~     management and outcome of patients with acute ischaemic stroke under NOAC compared to VKA.~   "
92716|NCT02353572|"~     This phase I/II trial studies the safety and best dose of melphalan and bortezomib when given~     prior to an autologous stem cell transplant and to see how well they work in treating~     patients with multiple myeloma. Drugs used in chemotherapy, such as melphalan, work in~     different ways to stop the growth of cancer cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Bortezomib may help melphalan work~     better by making cancer cells more sensitive to the drug. Giving chemotherapy before an~     autologous hematopoietic stem cell transplant helps kill any cancer cells that are in the~     body and helps make room in the patient's bone marrow for new blood-forming cells (stem~     cells) to grow. After treatment, stem cells are collected from the patient's blood and~     stored. More chemotherapy is then given to prepare the bone marrow for the stem cell~     transplant. The stem cells are then returned to the patient to replace the blood-forming~     cells that were destroyed by the chemotherapy. Giving melphalan together with bortezomib~     prior to autologous hematopoietic stem cell transplant may be a better treatment for multiple~     myeloma.~   "
92717|NCT02353559|"~     The purpose of this study is to test the feasibility of an individual psychological and~     physical symptom intervention, called Emotion And Symptom-focused Engagement (EASE), to~     reduce traumatic stress and physical symptom burden in individuals newly diagnosed with acute~     leukemia.~   "
92718|NCT02353546|"~     Managing Cancer And Living Meaningfully (CALM) is a brief psychotherapy designed to alleviate~     distress in advanced cancer. In an earlier intervention-only pilot trial, CALM was associated~     with reductions in depressive symptoms and death anxiety and an increase in spiritual~     wellbeing. The purpose of this study is to assess the feasibility of a large-scale randomized~     controlled trial (RCT) of CALM and to identify preliminary effects in advanced cancer. This~     phase 2b pilot RCT employed intervention and usual care arms with 3 and 6 month follow-ups.~     The primary outcome was depressive symptoms (PHQ-9) and secondary outcomes included diagnosis~     of major depression (SCID), death anxiety, attachment security and spiritual wellbeing.~     Multilevel regression was used to compare change over time between groups. 60 patients with~     advanced cancer will be recruited from the Princess Margaret Cancer Centre, Toronto, Canada,~     and equally randomized into intervention and usual care conditions.~   "
92719|NCT02353533|"~     Adenomatous lesions of the colon are premalignant lesions which have the potential to develop~     cancer. Therefore adenomas should be resected endoscopically (endo- mucosa resection, EMR).~     EMR is conducted after submucosal injection of saline which allows to lift the desired lesion~     prior to resection. In some cases EMR is complicated due to incomplete or failed lifting~     after the injection of saline. This so- called non- lifting sign is a predictor for~     malignancy of the lesion. Difficult- to- lift polyps are also difficult- to- resect. A higher~     proportion of these lesions fail to be resected completely using the EMR technique.~      Alternatively, an over- the- scope full- thickness resection device (FTRD) can be used in~     order to resect colonic lesions. The FTRD technique has been described elsewhere (Schmidt et~     al. Gastroenterology 2014; 147: 740-742.e2). No comparative data exists until now on the~     performance of FTRD resection compared to standard EMR resection of difficult- to- resect~     colon adenomas.~      In this study the investigators aim to compare the success of FTRD versus EMR of difficult-~     to- resect adenomatous lesions (≤ 20 mm).~   "
92720|NCT02353520|"~     Initially, a written consent was obtained from each participant. Then they became familiar~     with the procedure. For intrarater reliability, the first rater assessed the strength of~     pinch grip, elbow flexion and shoulder abduction in three different sessions at short~     intervals on same day in same environmental conditions. All the assessments were performed on~     the same day in three sessions. Assessment duration of all the sessions was 5 minutes.~      For inter-rater reliability, Before the beginning of Procedure both the raters were~     familiarized with the motricity index. The motricity index was administered by two different~     raters on the same subjects within 2 days who were blind to each others results and heir~     results were recorded separately.~   "
92721|NCT02353507|"~     The purpose of this prospective, randomized, comparative multi-center study is to compare the~     effective management of two silver-based dressings in managing exudative wounds in first and~     second degree burns.~   "
92722|NCT02353494|"~     This is an observational safety and efficacy study on dihydroartemisinin-piperaquine in~     Timika, Indonesia with a 42 day follow up period.~   "
92723|NCT02353481|"~     The aim of the study is to develop and assess a prognostic model for patient's survival up to~     1 year after unscheduled acute heart failure hospital admission in England and Wales.~   "
92724|NCT02353468|"~     This phase II trial studies how well giving bortezomib, lenalidomide, and dexamethasone~     together works in treating patients with multiple myeloma undergoing stem cell transplant.~     Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for~     cell growth. Biological therapies, such as lenalidomide, may stimulate the immune system in~     different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as~     dexamethasone, work in different ways to stop the growth of cancer cells, either by killing~     the cells or by stopping them from dividing. Giving bortezomib, lenalidomide, and~     dexamethasone together may kill more cancer cells.~   "
92725|NCT02353455|"~     Drug metabolism in the liver is subject to large fluctuations (differences between women and~     men, people of different ethnic backgrounds, children and adults). These large differences~     are responsible for very different drug effects and side-effects (and especially liver damage~     caused by drugs) between individuals. Recent scientific findings suggest that blood derived~     cells can be used to model individual effects of drugs on the liver reflect inter-individual~     differences. Since liver damage caused by drugs is a diagnosis of exclusion, the~     aforementioned cells can be used to identify patients that show higher sensitivity to~     hepatotoxic side-effects and - in case several drugs are involved - identify the causal agent~     or possible interactions.~   "
92726|NCT02353442|"~     To identify biomechanical and sensibility changes in people with posterior capsule tightness~     in people with and without shoulder pain.~   "
92727|NCT02353429|"~     This is a prospective study evaluating the activity and the safety of toremifene in patients~     with primary or recurrent sporadic DTs.~      Patients will be enrolled after the histological confirmation of DTs on biopsy Patients will~     start at 60 mg daily and dose-escalate to 180 mg upon progression. Disease assessment will be~     performed by contrast-enhanced MRI or CT scan, pain evaluation by a visual analog scale (VAS)~     every 3 months for the first and second year, twice yearly thereafter. Response will be~     evaluated either by RECIST and/or symptomatic relief.~   "
92728|NCT02353416|"~     Advanced glycation end products (AGE) result from a chemical reaction between the carbonyl~     group of reducing sugar and the nucleophilic NH2 of a free amino acid or a protein; lysine~     and arginine being the main reactive amino acids on proteins. Following this first step, a~     molecular rearrangement occurs, rearrangement of Amadori resulting to the formation of~     Maillard products.~   "
92729|NCT02353403|"~     The study aims to evaluate the glycaemic and insulinaemic response of short-chain~     fructo-oligosaccharides (scFOS) used to replace sugars (e.g. dextrose) in foods.~   "
92730|NCT02353390|"~     This is a randomized controlled open-label trial. During the study, adolescents and young~     adults scheduled to receive at least one intra-muscular (IM) vaccine will receive either oral~     water hydration in addition to standard care or standard of care alone to evaluate the effect~     of water hydration on the primary outcome of presyncope. This study will also evaluate the~     acceptability of pre-vaccination hydration among adolescents and young adults.~   "
92731|NCT02353364|"~     The study is designed to evaluate the effectiveness of pre-implantation genetic screening~     (PGS) for infertility patients of advanced maternal age undergoing assisted reproductive~     treatment. Half of the patients will have their embryos tested by PGS and 1 or 2~     chromosomally normal embryos with the highest morphological grading transplanted back to the~     uterus. The other half of the participants will not have their embryos tested and 1 or 2~     untested embryos with the highest morphological grading transplanted back to the uterus.~   "
92732|NCT02353351|"~     Prospective, multicenter, case-cohort study.To identify potential risk factors associated~     with the occurrence of erosion due to implantation of the AMPLATZER™ Septal Occluder (ASO.)~   "
92733|NCT02353338|"~     Background: Wrist fractures are a common injury among people aged 55-70. The radius is one of~     the bones making up the wrist joint, and is typically the site of injury in a broken wrist.~     Methods of treating a broken radius include placing the wrist in a cast for 6 weeks~     (conservative management) or receiving surgery. Surgery allows for earlier movement of the~     wrist and return to activity, while being placed in a cast is less invasive than surgery.~      Surgery to fix these fractures has become more common; however there is little agreement~     about who should receive surgery and who should be placed in a cast to heal. The goal of this~     study is to compare outcomes between people aged 55-70 who have broken their wrist and had~     surgery, and those who received a cast.~      Procedures: Participants in this study will be randomly assigned to one of two study groups~     within 1 week of injury at their first clinic visit with the surgeon.~      Patients in Group A (surgical management) will continue with casting for a total of 6 weeks,~     as indicated by the surgeon.~      Patients in Group B (conservative management) will receive surgery, and the attending surgeon~     will determine the best fracture fixation method for the wrist.~      The research coordinator will assess the injured wrist at 6 weeks, 3, 6, and 12 months after~     the initial injury. At each assessment, the wrist will be examined and participants will be~     asked to fill in some questionnaires about health, pain, wrist function, and satisfaction~     with the wrist. An X-ray will also be performed on the wrist to assess bone healing.~     Information from each visit will be used to determine how participants are doing and to~     compare the 2 study groups.~   "
92734|NCT02353325|"~     Salt is one of the very few regularly purchased food item in all socioeconomic classes~     including poor remote areas with subsistence farming. Therefore, it is a promising vehicle~     for fortification with micronutrients, such as iodine, iron, vitamin A, to alleviate the~     burden of micronutrient deficiencies. However, ensuring the bioavailability of iron and the~     sensory quality in fortified salt is difficult. Water-soluble iron compounds, such as ferrous~     sulphate FeSO4, are the most bioavailable, but they react with moisture and impurities in~     salt, and cause unacceptable changes in colour. Encapsulation can reduce iron-mediated colour~     change in fortified salt without significantly compromise bioavailability. In the present~     project we aim to investigate the iron bioavailability from salt fortified with FeSO4 using a~     new encapsulation type based on hyaluronic acid (HA) and a polymer from the eudragit family~     (EPO).~   "
92735|NCT02353312|"~     To study the hypothesis that treating patients with underlying diastolic dysfunction with~     oral Kuvan® (BH4, also known as tetrahydrobiopterin) in addition to current best practices~     will improve metabolic and echocardiographic diastolic function parameters.~   "
96947|NCT02298231|"~     This research study evaluates the effectiveness of a low-cost Virtual Reality-based (VR)~     training system in providing a customized balance treatment in a skilled clinical setting.~     Participants will be assigned to one of three treatment groups.~   "
92736|NCT02353299|"~     This is a Phase IV, randomized, double-blind, placebo-controlled, four-arm crossover study.~     The study will assess the effects of a single dose of Silenor 6 mg compared with matching~     placebo and a single dose of zolpidem 10 mg compared to its matching placebo at the~     respective T-max in normal healthy adult male volunteers. The study will be conducted in~     approximately 52 male subjects~   "
92737|NCT02353286|"~     Patients with either post-cholecystectomy bile leak or benign biliary stricture are recruited~     for endoscopic insertion of a biodegradable biliary stent. A follow-up of 12 months with~     repeated serum samples and magnetic resonance imaging is scheduled. The primary end points~     are feasibility of endoscopic insertion with the novel implantation device and stricture or~     leak resolution as well as clinical treatment success.~   "
92738|NCT02353273|"~     The objective of this study is to evaluate the systemic exposures of WH-1 ointment which~     includes Salvigenin and Asiaticoside A in subjects with chronic diabetic foot ulcers~     following topical application of WH-1.~   "
92739|NCT02353260|"~     The purpose of this study is to determine whether Ultrasound Hyperthermia is effective and~     safe in the treatment of Oral and Maxillofacial-Head and Neck Cancer.~   "
92740|NCT02353247|"~     The overall objective of this study is to confirm that oral progesterone is an effective way~     to manage bothersome bleeding; thus increasing the rate of continuation of the etonogestrel~     contraceptive implant in adolescents.~   "
92741|NCT02353234|"~     The consumption of wholemeal cereals has been associated with the reduction of several~     chronic diseases. The mechanisms behind these protective effects may be linked, besides~     dietary fiber and micronutrients, to an increased intake of phenolic compounds, mainly,~     hydroxycinnamates contained in the bran. Among bran fractions, aleurone usually contains the~     highest concentration of ferulic acid, principally contained as monomeric form and diferulic~     acid esters linked to arabinoxylans, representing the most relevant subclasses. The aim of~     the study was to evaluate the absorption of hydroxycinnamates by measuring the urinary~     excretion of phenolic metabolites in humans fed with two different kind of a commercial~     bread, as wholegrain bread and a white bread enriched with aleurone fraction. Moreover, the~     pharmacokinetics of the main phenolic compounds was also evaluated by measuring the~     circulating metabolites in plasma samples.~   "
92742|NCT02353221|"~     The CPMC early arthritis registry will recruit participants from a population of new patients~     undergoing evaluation at the office of participating physicians. Patients enrolled in the~     registry will undergo longitudinal observation and sampling. The investigators will collect~     questionnaire data and create a biological sample repository. The information obtained will~     be use to generate hypotheses aimed at explaining how environmental and genetic factors are~     interrelated to influence UA disease outcomes. Analysis will be performed on the patient's~     data and biological samples in order to; A. Assess the epidemiological and clinical~     characteristics of patients with early arthritis in the referral pool at CPMC.~      B. Analyze the phenotype and genotype of peripheral blood mononuclear cells (PBMC) from~     individual patients based on their chemokine/cytokine secretion, cell adhesion molecule~     expression, gene expression, DNA methylation and non coding RNA profiles.~      C. Generate hypothesis aimed to identify clinical criteria and novel biomarkers to be used in~     the diagnosis, prognosis, and therapeutic decisions for patients with early UA~   "
92743|NCT02353208|"~     Capsule endoscopy is a non-invasive way to examine the small bowel, but its yield is limited~     by the battery life. In 20% of cases, the recording stops before the entire length of small~     bowel is examined. Capsule transit speed is dependent on bowel motility. When we eat, the~     brain sends signal to the bowel to speed up motility. In this study the investigators wish to~     determine if chewing bacon (sham feeding) can trick the brain to speed up bowel motility and~     improve the rate of complete small bowel examination.~   "
92744|NCT02353195|"~     The aim of this study was to evaluate the potential clinical benefits of Monopolar Capacitive~     Resistive Radio-frequency (448 kHz) (MCRR)F for the treatment of myofascial chronic neck~     pain.~   "
92745|NCT02353182|"~     Animal studies suggest general anaesthetics harm the developing brain. It is unclear if these~     findings are relevant to humans but the issue has become a major concern. Recent data have~     found that monkeys exposed to anaesthesia as infants grow up to have slower learning than~     those not exposed.~      The aim of the TREX pilot study is to determine the feasibility of an alternative anaesthetic~     regimen for lower abdominal/lower extremity surgery in infants 1-12 months of age.~   "
92746|NCT02353169|"~     Dexmedetomidine is a sedative drug that is commonly used to improve calmness and reduce pain~     in children waking up after surgery. Some of the side effects of dexmedetomidine, such as a~     potential change in how the heart muscles contract and changes in blood sugar and potassium~     levels, are poorly understood. The current study aims to examine these changes directly in~     healthy children undergoing elective surgery by measuring the heart beats (with an~     electrocardiogram) and blood sugar and potassium at specific times before and after~     dexmedetomidine is given. The investigators aim to establish a better understanding of this~     drug's safety profile.~   "
92747|NCT02353156|"~     The investigator will perform a randomized clinical trials to compare the effect of pain~     management and wound healing after hemorrhoidectomy between warm sitz bath and electronic~     bidet.~   "
92748|NCT02353143|"~     The purpose of this study is to assess the safety of MEN1112, given as intravenous infusion,~     in patients with relapsed or refractory AML. Pharmacokinetics, clinical activity and~     potential immunogenicity of MEN1112 will be evaluated as well.~   "
92761|NCT02352974|"~     The objectives of this study is to~        -  Evaluate the safety of giving GAD-Alum (Diamyd) directly into lymph glands in~          combination with an oral vitamin D regimen~        -  Evaluate how the above mentioned treatments influence the immune system and endogenous~          insulin secretion.~   "
92790|NCT02352597|"~     Prospective study conducted on 150 women with polycystic ovarian syndrome (PCOS) were~     randomly divided into 3 groups: group I (50 women) received clomiphene citrate (CC) only 50~     mg orally every 8 hours started from cycle day 3 for 5 days, group II (50 women) received 2mg~     estradiol valerate daily from cycle day 7 - 11 in addition to CC and group III (50 women)~     received phytoestrogen (20mg of cimifuga racemosa from day 1- 12) in addition to CC.~   "
92791|NCT02352584|"~     A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Phase III~   "
92749|NCT02353130|"~     Specific Aim 1: Obtain proof of concept evidence that cortical metrics will change in~     response to treatment with Memantine extended release (XR)®, an agent that modulates n-methyl~     d-asptartate (NMDA) receptor activation, in children with autism spectrum disorders (ASD) who~     clinically demonstrate treatment response.~      Hypothesis1: Children with ASD who have dramatic clinical response to Memantine XR® will~     exhibit changes in their cortical metrics, which will differ less from neurotypical children.~     Subjective ratings of improvement will be correlated with the change in cortical metrics.~      The completion of these aims will be essential to design a larger federally funded trial to~     validate cortical metrics as an outcome measure in a more heterogeneous pediatric ASD sample.~     Specifically, the feasibility data obtained may demonstrate the potential for detecting~     changes in cortical metrics over time, so that a larger grant could focus on determining how~     sensitive and clinically relevant changes in cortical metrics are or may indicate the need to~     explore different interventions to use in a validation study. We have chosen to use Memantine~     XR® because of its impact on NMDA neurotransmission, its current evaluation in a large~     multi-site randomized ASD clinical trial whose initial results are expected shortly, and our~     own observations of clinical improvements and good tolerability in the ongoing trial.~   "
92750|NCT02353117|"~     Nearly 1.5 million pregnant women are infected with syphilis each year, and it is estimated~     that half of them will have adverse birth outcomes. Congenital syphilis remains a major~     public health issue, despite the fact that maternal syphilis is easy to detect and treat.~     Multiple barriers impair the elimination of congenital syphilis. Syphilis is often~     stigmatized and of low priority, and even women attending prenatal care early are potentially~     facing multiple clinical barriers. The study objective is to use implementation research~     methods to evaluate a multifaceted intervention to increase the use of evidence-based~     clinical procedures to prevent congenital syphilis. The investigators will perform a~     facility-based, two-arm parallel cluster randomized implementation trial in the Democratic~     Republic of the Congo and Zambia. The intervention will be multifaceted, tailored by~     formative research, and include: opinion leaders, reminders, monitoring, and feedback;~     point-of-care rapid tests; and treatment kits to be used immediately if the rapid test is~     positive. Improving syphilis screening and treatment will be promoted as a key step toward~     improving the quality of all components of prenatal care.~   "
92751|NCT02353104|"~     This open-label, adaptive-design, pilot study was designed to evaluate the effect of~     Onion-Pumpkin Extract in supporting healthy blood pressure as assessed by the change in~     systolic and diastolic blood pressures. The effect of the product on glucose metabolism,~     lipid levels, and antioxidant levels would also be determined. Tolerability and safety of the~     study product would also be investigated.~   "
92752|NCT02353091|"~     Auditory Processing Disorder (APD) is a disorder where the functions of the ear (outer,~     middle, inner) are normal but the person has difficulty identifying or discriminating sounds~     (Dawes & Bishop, 2009) and experiences listening difficulties in noise. Personal Frequency~     Modulation (FM) systems are wireless listening devices that pick up the speaker's voice and~     transmit it to a receiver in the listener's ear. In this way, the negative effects of ambient~     noise, distance from speaker and reverberation are reduced (Keith & Purdy, 2014).~      The principal research question is whether FM systems improve auditory attention, listening~     in noise performance and listening in spatialised noise in children with Auditory Processing~     Disorder (APD) in relation to just auditory training alone. We hypothesize that the FM system~     will lead to improved attention scores, improved speech in noise perception (aided and~     unaided) and improved ability to listen in spatialised noise that after prolonged FM use (6~     months). Additionally, we hypothesise that these results will correlate with questionnaires~     (filled out by parents, teachers and children).~      Thirty (30) children with a diagnosis of an APD from the Great Ormond Street Hospital~     Audiology clinic will be recruited. The children need to fulfil the following criteria:~        1. Diagnosis of APD (based on routine clinical tests at GOSH):~             1. Abnormal performance on the auditory figure ground test (a speech in noise test) of~               the SCAN-C (i.e. at the 1st percentile score as per UK norms), or in the High-Cue~               or Low-Cue score of the LiSN-S test and~             2. Abnormal performance in one non-speech auditory processing test (frequency pattern,~               duration pattern, gaps in noise or random gap detection pattern tasks), and~             3. Parent reported speech in noise and other listening difficulties.~        2. No neurological disorder, pervasive or attention deficit disorder or developmental~          delay.~        3. Normal IQ.~        4. Age range 8-11 years.~   "
92753|NCT02353078|"~     Could Sucralfate be a non-steriodal treatment option for patients with Eosinophilic~     esophagitis?~   "
92754|NCT02353065|"~     Colles fractures are a common type of wrist fracture that often requires manipulation in the~     Emergency Department. Currently xrays are used to assess whether this has been successful,~     which are done once the plaster cast has been applied. This study will assess whether~     ultrasound can be used immediately after the manipulation to check the position, before the~     plaster cast is applied. This would then be followed by an xray as normal.~      The aim is to assess the feasibility of a full study to determine which method is faster,~     causes less pain, and also to assess if either approach reduces the need for repeat attempts~     at manipulation and surgical repair.~   "
92755|NCT02353052|"~     Evaluate the reliability of morphology standards for GIST pathologic type, staging and~     grading by retrospective analyzing clinical data; on this basis, establish a GIST~     standardized and individualized treatment mode to maximum benefit GIST patients, avoid under-~     and over-treatment.~   "
92756|NCT02353039|"~     The purpose of this study is to evaluate the efficacy and safety of the investigational~     products in the patients with gastritis during their participation in the study.~   "
92757|NCT02353026|"~     This is a Phase One study to determine the safety, tolerability, and maximum tolerated dose~     of intravenous artesunate in patients with solid tumors. A rapid dose escalation design will~     be used, in which single patients will be enrolled to escalating dose levels until a grade 2~     or higher toxicity occurs during cycle 1. Enrollment will then continue using 3 to 6 patients~     at each dose level until a dose is reached at which 2 or more patients out of 6 experience a~     treatment-related toxicity.~   "
92758|NCT02353013|"~     The investigators will compare weight gain based on fat accretion and change in body~     composition in preterm infants receiving different amounts of enteral protein.~   "
92759|NCT02353000|"~     Recently stereotactic radiosurgery (SRS) in 5 up to 10 brain metastases showed to have equal~     survival as in 2 up to 4 brain metastases. Whole brain radiotherapy (WBRT) is currently the~     gold standard for patients with more than 3 brain metastases, but has significant side~     effects. In this prospective randomized phase III trial WBRT is compared to SRS for patients~     with 4 up to 10 BM.~   "
92760|NCT02352987|"~     This study is designed to find out the effectiveness of combination of ethanol extract of~     neem leaf, propylene glycol (40%) and salicylic acid (10%) in the treatment of palmar~     arsenical keratosis.~   "
92762|NCT02352961|"~     There are both supply and demand gaps in our understanding of how best to implement MMC~     services. In terms of supply of MMC services, there is a need to better understand what the~     best way is of efficiently accessing mature men(25-49 years old) . The investigators also~     want to understand the type of service delivery approach and environment that would make~     mature men(25-49 years old) feel more comfortable when attending an MMC clinic. Demand of MMC~     requires identifying messaging that works to address mature men's (25-49 years old) issues so~     that they might be willing to undergo MMC. To further advance HIV prevention and advocacy of~     male circumcision the investigators also need to consider the perspectives of women on what~     approach MMC messaging should take. A combination of male and female viewpoints could inform~     MMC outreach messaging where IEC materials are tailored to address the barriers to MMC.~     Identifying the specific barriers to MMC among males and including the perspectives~   "
92763|NCT02352948|"~     This study is a Phase III, randomised, open label, multi-centre study assessing the efficacy~     and safety of MEDI4736 (durvalumab) versus Standard of Care in NSCLC patients with PD-L1~     positive tumours and the combination of MEDI4736 (durvalumab) plus tremelimumab~     (MEDI4736+treme) versus Standard of Care in NSCLC patients with PD-L1-negative tumours in the~     treatment of male and female patients with locally advanced or metastatic NSCLC (Stage~     IIIB-IV), who have received at least 2 prior systemic treatment regimens including 1~     platinum-based chemotherapy regimen for NSCLC. Patients with known EGFR (Epidermal growth~     factor receptor) tyrosine kinase (TK) activating mutations and anaplastic lymphoma kinase~     (ALK) rearrangements are not eligible for the study (prospective testing is not planned~     within this study). The Standard of Care options are: an EGFR tyrosine kinase inhibitor~     (erlotinib [TARCEVA®]), gemcitabine or vinorelbine (NAVELBINE®).~   "
92764|NCT02352935|"~     The purpose of this study is to investigate the safety and efficacy of irreversible~     electroporation for unresectable Hepatic carcinoma in poor liver function, also Progress Free~     Survival (PFS) and Over Survival (OS) will be recorded.~   "
92765|NCT02352922|"~     The investigators are studying ways to improve pain control after surgery. One way to~     decrease pain is to inject incisions with a numbing medicine (local anesthetic) while in the~     operating room. There is an FDA approved extended-release version of a commonly used local~     anesthetic (bupivacaine) that can last for 4 days instead of 6 hours. The investigators are~     studying whether using the extended-release medication (Exparel) will give better pain relief~     after laparoscopic and robotic-assisted hysterectomies.~   "
92766|NCT02352909|"~     From a rehabilitation point of view, while several approaches exist to retrain runners with~     PFPS, it is not clear which one is most effective, or why. The goals of this~     randomised-controlled trial are: 1) to compare the effectiveness of three rehabilitation~     programs on pain and functional limitations of runners with PFPS and 2) to explain why the~     programs are effective or not based on laboratory analyses. After baseline evaluation,~     runners will be randomly assigned to one of three treatment groups, each with a specific~     8-week rehabilitation program aimed at addressing the efficiency of a specific type of~     retraining. These groups are: 1) Control; 2) muscle recruitment; 3) reducing knee loading~     during running.~      The investigators hypothesis is that the intervention targeting a reduction in knee loading~     will be significantly more effective in reducing symptoms and improving function of runners~     with patellofemoral pain syndrome.~   "
92767|NCT02352896|"~     EPI-743 in Leigh syndrome subjects that participated in previous EPI743-12-002 study.~   "
92768|NCT02352883|"~     This clinical trial studies magnetic resonance imaging (MRI) and gene expression in~     diagnosing patients with abnormal cells in the breast duct that have not spread outside the~     duct. MRI uses radio waves and a powerful magnet linked to a computer to create detailed~     pictures of areas inside the body. MRI may help find and diagnose patients with breast~     cancer. It may also help doctors predict a patient's response to treatment and help plan the~     best treatment. Genetic studies may help doctors predict the outcome of treatment and the~     risk for disease recurrence. Performing MRI with genetic studies may help determine the best~     treatment for patients with breast cancer in situ.~   "
92769|NCT02352870|"~     To explore whether it is feasible to recruit and retain haemodialysis patients into a~     randomised controlled trial of online cognitive-behavioural therapy to manage distress~   "
92770|NCT02352857|"~     The study aims to evaluate the glycaemic and insulinaemic response of short-chain~     fructo-oligosaccharides (scFOS) used to replace sugars (e.g. dextrose) in foods.~   "
92771|NCT02352844|"~     The purpose of this research study is to look at participants with solid tumor malignancies~     and specific mutations respond to treatment with everolimus.~   "
92772|NCT02352831|"~     There are two parts to this study: the goal of the first part of the study is to find the~     best dose of tosedostat when given in combination with capecitabine. The goal of the second~     part of the study is to look at how participants respond to treatment with tosedostat and~     capecitabine.~   "
92773|NCT02352818|"~     The aim of this CTO registry is to gather data including patient demographic date, cardiac~     risk factors, procedural technical data and procedural success/outcome rates. Furthermore, we~     aim to evaluate the safety and performance of various CTO specific guidewires, devices (such~     as the CrossBoss/Stingray dissection ren-entry device) and other recognised and approved~     techniques (retrograde wire escalation, retrograde dissection re-etry techniques). The~     incidence of recognized complications (dissections, perforations, cardiac tamponade, vascular~     complications, radiation injury, acute kidney injury) will also evaluated. We will assess~     clinical outcome at 1 year after succesful CTO procedures.~   "
92774|NCT02352805|"~     This observational clinical study investigates cellular and plasmatic activation markers as~     well as proteins involved in coagulation and inflammation in patients being connected to~     different extracorporeal circulation (ECC) and circulatory support devices under intensive~     care conditions.~   "
92775|NCT02352792|"~     Patients with locally advanced suqamous cell carcinoma of the head and neck region receive a~     hypoxia scan either by magnetic resonance tomography, computed tomography or~     fluoromisonidazole (FMISO)-PET-CT. Patients presenting with hypoxia are randomized into~     standard therapy consisting of intensity modulated radiotherapy (IMRT) with 70 Gy plus either~     5-fluorouracil/mitomycin C or cisplatinum (Arm A) or a dose escalation of 10% (77Gy) to the~     hypoxic volume applied via simultaneous integrated boost in addition to the standard~     treatment (Arm B).~   "
92777|NCT02352766|"~     Recently, targeted next generation sequencing (NGS) platforms have been introduced that allow~     inexpensive testing for hundreds of mutational hotspots at the same time. A number of~     additional mutational markers in thyroid cancer have been identified. Highly promising~     markers associated with tumor prognosis have also been found. This multi-institutional study~     aims to validate the diagnostic use of mutational markers in thyroid nodules with~     indeterminate cytology.~      The proposed hypothesis is that a broad NGS-based genotyping of thyroid nodules using a large~     panel of mutational markers applied to thyroid FNA samples can provide an accurate cancer~     risk stratification in thyroid nodules.~      The performance of the panel will be tested in a multi-institutional double-blind prospective~     study of FNA samples from thyroid nodules with indeterminate cytology and available surgical~     outcome~   "
92778|NCT02352753|"~     This is a prospective, multicenter, single-arm study in children 2 to 17 years of age with OI~     to evaluate efficacy and safety of denosumab.~   "
92779|NCT02352740|"~     The purpose of this study is to compare the metabolic fate of two oral forms of L-Arginine in~     healthy subjects featuring metabolic syndrome related risk factors~   "
92780|NCT02352727|"~     To quantitative measurement of nocturnal hypokinesia of Parkinson's disease patients compares~     with their spouses by using multisite accelerometers for 1 night at their home. To determine~     whether the nocturnal movement of Parkinson's disease patients less than normal elderly~     people or not.~   "
92781|NCT02352714|"~     This study aims to compare pain during insertion of the Skyla® IUS using a 100mm visual~     analog scale (VAS) among 92 young women aged 14 to 22 years randomized to receive a~     paracervical (n=46) block versus a sham paracervical block (n=46).~   "
92782|NCT02352701|"~     This study compared efficacy and safety of basic triple therapy including Ilaprazole 10mg,~     Levofloxacin 500mg and Amoxicillin 1000mg BID for 10 days on the first line eradication~     treatment of H.pylori~   "
92783|NCT02352688|"~     This study evaluates the effects of enhanced geriatric input on elderly patients undergoing~     colorectal cancer surgery. Half of the participants will received additional pre, peri and~     post-operative care from the geriatric team, while the other half will receive standard~     surgical care.~   "
92784|NCT02352675|"~     Lysine analogs, like tranexamic acid (TXA) or epsilon aminocaproic acid (EACA), are~     antifibrinolytic agents routinely administered in children undergoing different surgeries~     associated with a high bleeding risk (e.g. cardiac, craniofacial, and orthopedic surgeries).~     Although there is a growing literature regarding the pharmacokinetic characteristics of these~     drugs in children, the plasmatic concentration required to completely inhibit fibrinolysis~     remains to be determined. In this in vitro study, the investigators will use an experimental~     model of fibrinolysis designed for rotational thromboelastometry (ROTEM®) to determine the~     minimal concentration inhibiting fibrinolysis for both TXA and EACA. In addition, this study~     will be used to create and validate a new experimental assay to measure fibrinolysis and the~     effect of antifibrinolytic agents.~   "
92785|NCT02352662|"~     This prospective study will aim to globally assess the coagulopathy induced during cardiac~     surgery with cardiopulmonary bypass (CPB) in a large pediatric population. The investigators~     primary objective will be the understanding of CPB-induced coagulopathy based on demographic~     and surgical characteristics, and coagulation assays. Secondary objective will aim at~     determining the relationship between coagulation assays, postoperative blood loss, and~     transfusion requirements. The ultimate goal will be to design an algorithm using~     point-of-care monitoring that could be used to guide hemostatic therapies in neonates and~     children undergoing cardiac surgery.To do this, investigators will examine the coagulation in~     the laboratory based setting.~   "
92786|NCT02352649|"~     The purpose of this study is to determine safety and efficacy of pl-vegf165 (Neovasculgen)~     for regeneration of peripheral nerve. Pl-vegf165 (Neovasculgen) is the permitted in Russian~     Federation angiogenic medication that induce growth of new vessels and included in a complex~     therapy for patients with peripheral arterial diseases in Russia. It has also been shown to~     enhance nerve regeneration and muscle reinnervation in animals but these properties have not~     previously been studied in patients. Moreover, currently there is no method in clinical use~     to speed the rate of recovery after nerve injury. The objective of this study is to explore~     the ability of pl-vegf165 to benefit the treatment of patients with peripheral nerve injury.~     The investigators hypothesize that treatment with intraneural injections with pl-vegf165~     after peripheral nerve reconstruction will accelerate nerve regeneration, reduce the period~     of denervation and improve muscle reinnervation and recovery in patients with peripheral~     nerve injury.~   "
92787|NCT02352636|"~     Osteoarthritis (OA) is the most common form of arthritis in Hong Kong and a prevalent~     condition in the ageing population. With disease progression, some clients may develop severe~     pain and profound limitations in ambulation, which may result in morbidity and impaired~     physical functions. Among the available treatments, pharmacological therapies primarily focus~     on musculoskeletal pain relief. However, adverse effects, such as gastrointestinal~     haemorrhage arising from non-steroidal anti-inflammatory drugs have led to an increasing~     number of concerns regarding the use of these treatments. Other non-invasive complementary~     methods for osteoarthritic knee (OA knee) should be explored because of the limitations of~     pharmacological therapy.~      Auriculotherapy (AT) is one of the approaches in traditional Chinese medicine (TCM). It is a~     therapeutic method by which specific points on the auricle are stimulated to treat various~     disorders of the body. The present study is a four-arm randomised controlled study to~     determine the effectiveness of AT using magneto-AT (MAT) and/or laser AT (LAT) to improve the~     conditions of elderly patients suffering from OA knee. The effectiveness of MAT and LAT in~     terms of alleviating pain, relieving stiffness and promoting a range of motion, and enhancing~     functional abilities will be determined.~      Subjects in 'Treatment arm 1' will receive MAT on specific auricular points on one side of~     the ear during each treatment session. A deactivated laser will be used to achieve the effect~     of subject blinding. Subjects in 'Treatment arm 2' will receive LAT using low-energy laser~     applied to selected acupoints of the ear, and a plaster centred with a portion of Junci~     Medulla that mimics MAT treatment will also be given. Subjects in 'Treatment arm 3' will~     receive a combined approach (both MAT and LAT). Subjects in the 'placebo arm' will serve as~     placebo controls. Six auricular acupoints that are considered to have an effect on the OA~     knee will be selected. Only one ear at a time will receive treatment. Thus, the ears will be~     treated alternately. The total treatment period will be four weeks. The experimental objects~     will be replaced every other day. Therefore, treatment will be performed thrice a week.~     Subjects will be assessed at baseline up to 3 months after the therapy. This study could~     advance the knowledge on the complementary approaches than can be used to improve OA knee~     conditions in the elderly.~   "
92788|NCT02352623|"~     Health-related Quality of life in Danish stage IB-III cutaneous melanoma patients.~   "
92789|NCT02352610|"~     A Prospective Randomized Trial Comparing Standard Ligament Reconstruction Tendon~     Interposition (LRTI) VS Ligament Reconstruction Tendon Interposition (LRTI) with an~     interference screw for thumb carpometacarpal arthritis~   "
92792|NCT02352571|"~     The purpose of this study is to determine the maximum tolerated dose(MTD)/Recommended Phase 2~     Dose(RP2D) and to evaluate the safety and tolerability of GC1118 when given by intravenous~     (IV) infusion to patients with stage IV solid tumors.~      The study will also evaluate pharmacokinetics, immunogenicity and antitumor effect of GC1118~     and explore prognostic biomarkers and pharmacodynamic biomarkers.~   "
92793|NCT02352558|"~     This is a multicenter, open label, Phase 1 dose-escalation study of BBI608 administered to~     patients with relapsed, refractory hematologic malignancies, including multiple myeloma,~     lymphoma, and others.~   "
92794|NCT02352545|"~     Cough is a common symptom of respiratory medicine clinic patients, which has complex etiology~     and wide-ranging. Cough is usually divided into three categories by time: acute cough,~     subacute cough and chronic cough. Subacute has a 3~8 weeks course of disease. Its main~     etiology is postinfectious cough, which is mostly secondary to viral infection.Considering~     its overexpression in postinfectious patient, Cysteinyl leukotriene (CysLTs) plays a role in~     gathering eosinophils to respiratory. The level of FENO has a significant correlation with~     inflammatory airway eosinophils. While CysLTs overexpressed in vivo, the level of FENO may~     increase. Montelukast, as CysLTs-receptor-1 antagonists， plays a role of controlling airway~     inflammation and decrease airway high activity by suppressing the biological activity of~     CysLTs. It is effective in theory to therapy sub-acute cough by Montelukast, to short the~     course and to relieve cough symptoms as soon as possible. The aim is to research whether FENO~     can be used as a biomarker to optimized treatment regimen of sub-acute cough.~   "
92795|NCT02352532|"~     The focus of this project is to evaluate the diagnostic utility of Shear Wave Elastography~     (SWE) in individuals after routine low back injury and begin an initial investigation of it's~     ability to effectively guide physical therapy treatment with dry-needling as a relevant~     treatment intervention.~      Specific Aim #1: Evaluate the diagnostic utility of SWE in differentiating individuals with~     and without LBP. The investigators will also examine the interaction between tissue change~     and clinical improvement. The investigators hypothesize that individuals with LBP will have~     higher muscle stiffness (shear modulus) at rest and impaired (lower) stiffness during~     contraction than individuals without LBP.~      Specific Aim #2: Evaluate the effectiveness of dry-needling in decreasing aberrant muscle~     stiffness in individuals with LBP. The investigators hypothesize that individuals with LBP~     that receive dry-needling will exhibit larger changes than both individuals with LBP that~     receive sham dry-needling and than individuals without LBP that receive dry-needling.~      Specific Aim #3: Evaluate the effectiveness of dry-needling in decreasing pain and disability~     in individuals with LBP. The investigators hypothesize that individuals with LBP that receive~     dry-needling will exhibit larger improvements than individuals with LBP that receive sham~     dry-needling.~   "
92796|NCT02352519|"~     In this research study, the investigators are trying to find out which of the two methods of~     injecting local anesthetics (at the site of the belly button cut or by ultrasound guided~     rectus sheath block) will provide better pain relief and less need for pain medication after~     surgery in children undergoing single incision laparoscopic appendectomy.~   "
92797|NCT02352506|"~     Acute kidney injury (AKI) is a common complication in critical care patients. Currently no~     parameters are available for early prognosis of AKI. Macrophage migration inhibitory factor~     (MIF) has been associated with AKI in clinical studies. The aim of this study is to evaluate~     the time course of MIF concentrations in patients with AKI.~   "
92798|NCT02352493|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and~     pharmacodynamics of ALN-CC5 in healthy adult volunteers and subjects with PNH~   "
92799|NCT02352480|"~     The aim of this trial is to demonstrate the effectiveness of complete wound healing in a~     prospective, open-label, randomized trial in which diabetic food ulcers (DFU) will be treated~     using Aurix plus Usual and Customary Care (UCC) and compared to a group receiving just UCC as~     provided in up to 100 U.S. wound centers~   "
92800|NCT02352467|"~     The aim of this trial is to demonstrate the effectiveness of complete wound healing in a~     prospective, open-label, randomized trial in which pressure ulcers will be treated using~     Aurix and standard care and compared 1:1 to patients receiving undefined Usual and Customary~     Care.~   "
92801|NCT02352454|"~     The aim of this trial is to demonstrate the effectiveness of complete wound healing in a~     prospective, open-label, randomized trial in which venous leg ulcers (VLU)n will be treated~     using Aurix and compared to patients receiving undefined Usual and Customary Care (UCC)~   "
92802|NCT02352441|"~     Many Service members (SM) experience executive dysfunction associated with mild traumatic~     brain injury symptom complex (mTBI-sc), for which they receive cognitive rehabilitation.~     Cognitive rehabilitation (CR) for executive dysfunction often involves metacognitive strategy~     instruction (MSI) to help patients self-regulate their behavior though a goal management~     process - identifying a goal, anticipating performance problems, generating possible~     solutions, self-monitoring performance during the activity, recognizing maladaptive task~     strategies, stopping and then modifying real-time task behavior by choosing an alternate~     strategy. MSI alone often does not result in improved daily functioning because it requires~     conscious cognitive oversight to employ (which is difficult for people with executive~     dysfunction) and it presumes that simply establishing goals propels goal-directed action,~     when for many people, this is not so. Social psychologists report that people who set~     implementation intentions (if-then statements that link specific situational cues with~     specific goal actions) are more likely to perform goal actions than those who only set goal~     intentions. Implementation intentions are believed to be effective because they enable people~     to switch from conscious-effortful reflective action control to automatic, reflexive action~     control associated with selected situational cues. A team of researchers from the Courage~     Kenny Research Center (CKRC), Traumatic Brain Injury Center at Fort Campbell, KY (TBIC-FC),~     and Neurofunctional Research and Consulting has developed a brief CR intervention to teach SM~     with mTBI-sc to set implementation intentions called ACTION (AutomatiC iniTiation of~     IntentiONs) sequence training. The purpose of this pilot study to evaluate: 1) the~     practicality of instructional methods used to teach SM with mTBI-sc to perform the ACTION~     sequence and 2) the efficacy of ACTION sequence training in achieving personal goals and~     performance on a task that challenges executive function using a small randomized controlled~     trial. If the results are positive, a larger study would be conducted to determine the impact~     of ACTION sequence training on SM performance on military-relevant tasks and goals.~   "
92843|NCT02351895|"~     This is a prospective Infection Control study comparing rates of antibiotic usage and~     infections in the General Intensive Care Unit (GICU) in beds with copper impregnated linens~     versus regular linens.~   "
92882|NCT02351388|"~     This project will investigate the safety and efficacy of transcranial direct current~     stimulation (tDCS) in the treatment of depression among patients with Alzheimer's disease.~     The investigators aim to ameliorate depressive symptoms among patient with Alzheimer's~     disease, by anodal stimulation on left dorsolateral prefrontal cortex and cathodal~     suppression on right supraorbital area. Active stimulation will be compare to sham condition~     in 20 patients (10 in each groups).~   "
92803|NCT02352428|"~     The overall aim of this population-based screening study is to assess whether the skin cancer~     screening training of family physicians and dermatologists leads to improved screening~     outcomes. The training course aims to increase the accuracy of detecting early stages of skin~     cancer. Screening outcomes of an intervention region (Calgary, Canada) in which physicians~     receive training will be compared with screening outcomes of a control region (Edmonton,~     Canada) where no physician training is administered.~      The investigators will determine whether:~        -  clinical screening outcomes are more favorable in the group of trained physicians~          compared to non trained physicians~        -  there is an increase of knowledge about skin cancer screening among trained physicians,~          compared to non trained physicians~        -  skin cancer screenings are associated with psycho-social harms~        -  population-based screening has an effect on the overall incidence and~          stage-specific-incidence of skin cancer in Alberta~      The investigators are aiming to recruit 100 physicians per region (total of 200 physicians)~     who will screen 40,000 to 80,000 individuals over a period of 20 months.~   "
92804|NCT02352402|"~     In the POPular CABG study we investigate if the addition of ticagrelor, a drug that inhibits~     blood platelets from clotting, to treatment with aspirin will reduce the rate of saphenous~     vein graft occlusion as assessed with coronary computed tomography angiography at 1 year~     after coronary artery bypass grafting surgery.~   "
92805|NCT02352389|"~     The purpose of the proposed study is to gather critical information that may be useful in~     designing effective prevention and treatment strategies for control of seasonal influenza and~     an influenza pandemic. In particular, the critical questions are related to the virus'~     ability to adapt to efficient replication and spread in humans.~      Influenza is a contagious respiratory illness caused by influenza A and B viruses. Influenza~     infections result in about 230,000 hospitalizations and 36,000 deaths annually in the United~     States. Children with cancer are more likely to have serious influenza and complications than~     those who have no underlying medical problems. They are also more likely to have prolonged~     influenza illnesses and to shed influenza viruses from their noses for long periods of time~     (sometimes for months). Recent studies suggest that influenza viruses may also be carried and~     shed from the gastrointestinal tract. New types of influenza viruses emerge frequently~     through mutations that occur when the viruses replicate. These mutations allow the virus to~     escape from killing by the immune system and are, in large part, responsible for seasonal~     epidemics of influenza that occur in the fall or winter months. It is possible that viruses~     can mutate when they are carried in the respiratory or gastrointestinal tracts for long~     periods, potentially giving rise to viruses that spread more easily to other persons, cause~     more severe disease, lead to new influenza epidemics or make the viruses resistant to drugs~     used to treat influenza.~      Researchers at St. Jude Children's Research Hospital want to learn about how influenza~     viruses mutate in immunocompromised children. They will investigate how long children with~     cancer carry influenza viruses in their nose, throat and gastrointestinal tract and the~     characteristics of any mutations that are found in these viruses.~   "
92806|NCT02352376|"~     This is a prospective, quantitative, randomized, crossover study. Were included in this study~     10 people in the Intensive Care Unit at University Hospital in Uberlandia, on the first day~     of the postoperative coronary artery bypass graft (CABG). For data collection was performed~     randomization on the block (2: 4), to determine the first technique to be used and then a~     wash-out period of one hour was allowed for the research subject reaches the systemic~     arterial pressure, heart rate, respiratory rate and oxygen saturation baseline. And after,~     for cross-over, the second technique was performed. Non-invasive ventilation was performed~     for 30 minutes each ventilator. All subjects underwent noninvasive ventilation using two~     models of ventilators, they are conventional (designed for invasive ventilation but is also~     used in non-invasive ventilation mode) and specific (designed for non-invasive ventilation).~     Hemodynamic, autonomic and respiratory variables are monitored. We use the hypothesis that~     non-invasive ventilation performed with two fan models can alter autonomic function and that~     there is hemodynamic changes related to autonomic function in different ventilators in~     postoperative coronary artery bypass grafting.~   "
92807|NCT02352363|"~     This study is a 12-month, open-label, randomized, multicenter study which will evaluate the~     safety and efficacy of CVT-301 for the treatment of up to 5 OFF episodes per day in~     Parkinson's Disease (PD) patients experiencing motor fluctuations (OFF episodes) and will~     include a concurrent observational cohort of PD patients managed using the usual standards of~     care.~   "
92808|NCT02352350|"~     Blood lactate levels will be measured using a simple handheld device at time of return of~     spontaneous circulation (ROSC) following out of hospital cardiac arrest (OHCA). Patient~     outcomes tracked will include rate of survival to hospital discharge, rate of 6 month~     survival, and neurological status. The hypothesis for this pre-hospital study is to confirm~     the previous in-hospital findings that very high blood lactate after ROSC is associated with~     very high mortality and severe neurological impairment.~   "
92809|NCT02352337|"~     The pancreas cancer is the 4th cause of death. All stage confused, the survival at 5 years is~     note over 5 %. At metastatic stage, the pancreatic adenocarcinoma is an incurable disease~     with the survival median of 2-4 months without chemotherapy.~      Up to 2011, gemcitabine was the only reference treatment of this type of cancer. But until,~     the FOLFIRINOX could permitted to improve significantly the overall survival (6,8 months with~     gemcitabine vs 11,1 months with FOLFIRINOX) and the progression free survival (3,3 months~     with gemcitabine vs 6,4 months with FOLFIRINOX) for patients under 76 years. Main toxicities~     of this treatment are hematological, gastrointestinal and neuropathy with apparition of~     sensitive neuropathy, reversible, related to oxaliplatin.~      These results are on a population under 76 years old. In this study, the median age of~     patients at inclusion was 61 years old and FOLFIRINOX was still beneficial for patients more~     than 65 years old. Given the increase of proportion of patients than more of 65 years old~     with pancreatic cancer and given the increase of life expected, it is important to know the~     effectiveness and tolerance of such treatment for patient older than 65 years and 76 years.~      FIRGEM is an original strategic sequential treatment witch alternates, every 2 month, 4~     cycles of FOLFIRI.3 and 2 cycles of 3 injections of gemcitabine. There is no cross resistance~     known between this 2 treatments witch limit toxicities and preserve quality of life of~     patients. A Phase II trial testing this treatment regimen to classical regimen of~     gemecitabine, showed an overall survival of 11 months in the FIRGEM regimen and an overall~     survival of 8,2 months in the gemcitabine regimen. The rate of progression was 45% near of~     progression rate with FOLFIRINOX. Tolerance is close to that FOLFIRINOX regimen but this~     strategic doesn't induce limiting neurotoxicities and allow to use oxaliplatin in 2de line of~     treatment.~      The trial propose to evaluate the effectiveness and tolerance of FOLFIRINOX regimen (8~     cycles) with LV5FU2 in maintenance (that could increase the FOLFIRINOX tolerable without~     decrease efficiency), to FIRGEM regimen and to FOLFIRINOX (12 cycles) which is the reference~     regimen.~   "
92810|NCT02352324|"~     The main goal of our study is to assess the accuracy and reproducibility of continuous~     beat-to-beat cardiac output (CO) measurement using pulse wave transit time in patients~     undergoing off-pump coronary artery bypass grafting.~   "
92811|NCT02352311|"~     This is a randomized, open-label, single-dose, 2-treatment, 2-way, 2-period crossover study~     to evaluate the safety and the pharmacokinetic characteristics of DKF-313 (dutasteride and~     tadalafil) in healthy male volunteers.~   "
92812|NCT02352298|"~     The purpose of this study is to assess the performance of the Dario Blood Glucose Monitor~     (BGMS), at elevated altitudes, by obtaining whole blood fingerstick samples from individuals~     and analyzing the blood on the Dario Blood Glucose Monitor (BGMS) and comparing the readings~     to readings obtained from the YSI 2300 STAT Plus glucose analyzer.~   "
92813|NCT02352285|"~     The objective is to evaluate the efficacy and safety on the tolvaptan for increasing serum Na~     levels in patients with worsening heart failure and hyponatremia.~   "
92814|NCT02352272|"~     Objectives: investigate the effects of 6 nights of sleep extension on physical and cognitive~     performances before, during total sleep deprivation (39 hours continuous awaking) and after a~     subsequent recovery sleep.~      Design: Subjects participated in two experimental conditions (randomized cross-over design):~     extended sleep (10-h in bed, EXT) and habitual sleep (8-h in bed, HAB). In each condition,~     subjects performed two consecutive phases: (1) six nights of either EXT or HAB (2) three~     experiments days in-laboratory:baseline (BASE), sleep deprivation (TSD) and after 10 h of~     recovery sleep(REC). Performance tests were administered every 3 hours over the 3-d in~     laboratory.~      Setting: This cross-over and randomized study was conducted under standardized laboratory~     conditions with continuous polysomnographic recording Participants: 14 healthy men (age~     range: 26-37 years) participated in the study.~      Interventions: EXT vs. HAB sleep durations prior to total sleep deprivation (39 hr continuous~     awaking).~   "
92815|NCT02352259|"~     The study is prospective, phase II study, The primary objective of the study is evaluation of~     the feasibility and safety of intraoperative electrochemotherapy of colorectal liver~     metastases. The secondary objective is to determine the efficacy of electrochemotherapy~     treatment, based on histological and radiological evaluation of treated metastases. The~     endpoints are: toxicity according to the Common Terminology Criteria for Adverse Events~     (CTCAE) ver. 4.0 and response rate measured by percentage of vital tumor cells and mRECIST~     criteria.~   "
92816|NCT02352246|"~     Postmenopausal women, as men, are more prone to central or android obesity. Abdominal fat~     mass is associated with an increase of cardiovascular diseases (CVD). In type 2 diabetic~     (T2D) patients, the risk of CVD mortality is more than double compared with that in~     age-matched subjects.~      Most exercise programs designed for weight loss have focused on steady-state exercise (SEE)~     of around 30 min at a moderate intensity several times a week. Disappointingly, these kinds~     of exercise programs have led to little or no fat loss (Shaw et al. 2006). Accumulating~     evidence suggests that high intensity intermittent exercise (HIIE) has the potential to be an~     effective exercise protocol for reducing fat of overweight individuals, especially at the~     abdominal level (Boutcher 2011, Kessler 2012). Despite these results, HIIE program has never~     been used in TD2 postmenopausal women to favor a specific decrease of abdominal fat mass.~      The aim of our study was to compare the effects of 16-week steady-state exercise (SSE)~     program with high intensity intermittent exercise (HIIE) program on total abdominal and~     visceral fat mass in T2D postmenopausal women.~      It is hypothesized that HIIE compared to SSE program would result in significantly greater~     reductions in total abdominal and visceral fat mass.~   "
92817|NCT02352233|"~     Colonoscopy is the gold standard technique for diagnosis and treatment of colonic lesions.~     Moreover, high definition colonoscopes (HD) associated to digital chromoendoscopy had shown~     better results regarding adenoma and polyps detection when compared to standard non HD~     scopes. However, evidence shows that during standard colonoscopy many lesions could be~     missed, including polyps, cancer and other kind of lesions. This could be correlated to many~     factors and recently reports show evidence that lesions behind the folds could be missed~     because the limitation of a forward view examination. Until know, a new auxiliary imaging~     device called Third Eye Retroscope had demonstrated more lesions detection during~     colonoscopy using a retro view, but with some limitations as absence of HD vision, the need~     of additional equipment and the fact the device occupies the accessory channel, limiting~     therapeutic efficiency. Recently a new HD colonoscope called RETROVIEW (PENTAX Medical) has~     been developed. It permits visualization of colonic mucosa in forward view, in retroflex view~     and allows for performance of diagnostic and therapeutics in a single colonoscope.~   "
92818|NCT02352220|"~     COPD (Chronic Obstructive Pulmonary Disease) is a Public Health problem due to its impact in~     the patient's quality of life, high prevalence, growing incidence and socioeconomic~     implication. COPD natural history and first stages determinants are unknown. Knowing them~     will help to understand the natural history of the disease and to design interventions that~     can modify the prognosis of the disease.~      Study objectives: (1) To characterize an early COPD population from a multidimensional point~     of view including demographic, social, family and clinical data, lung function, exercise~     capacity, image, microbiology, quality of life, exacerbations, comorbidities and blood and~     sputum biomarkers. (2) To compare this patients with smoking subjects, with normal lung~     function, matched by age, sex and site. (3) To create an early COPD cohort to be followed in~     the future to understand the complete natural history of the disease.~      Methods: Design: multicenter cross-sectional study that will allow establishing a~     well-characterized cohort of early COPD patients for later follow-up. Recruitment will be~     done in Primary Care settings. Subjects: smokers (> 10 packs year) between 35-50 years old~     with a spirometry (normal or obstructive) done in the last year. Diagnosis of COPD will be~     based on the smoking history and a postbronchodilator test FEV1(Forced Expiratory Volume in~     the first second) / FVC(Forced Vital Capacity) < 70%. Age, sex and site matched 'healthy'~     smoker controls will be compared with the COPD cases. Variables that will be collected in the~     reference hospitals are: health questionnaires, lung function test, exercise capacity, blood~     and sputum samples, and low dose CT-scan. Statistical analysis: early COPD patient's~     characteristics will be described and then, will be compared, with control subjects through a~     conditional multiple logistic regression analysis.~   "
92819|NCT02352207|"~     This research focuses on lung malformations detected in fetuses during prenatal ultrasound~     exams. Pathogenic mechanisms of these rare malformations are poorly understood. Improved~     knowledge is needed, to give families better information, and to better standardize treatment~     decisions The main goal is to better predict neonatal complications associated with these~     malformations, by identifying key predictive markers during the fetal period.~      To achieve this objective, it is planned to include 400 pregnant women with prenatal~     diagnosis of pulmonary malformation in 45 health centers in France. This is the largest study~     on this topic at the international level.~   "
92820|NCT02352194|"~     The purpose of this study is to assess the physical capacity of patients with multiple~     sclerosis and the effects of rehabilitation, encompassing physical therapy and physical~     activity as it is carried out in the day hospital of (the Physical and Rehabilitation~     Medicine department) at Garches Hospital. We will compare the results of assessments carried~     out before and after a standard rehabilitation program.~   "
92854|NCT02351752|"~     IgA nephropathy is the most common type of primary glomerulonephritis and might caused by~     deposition of immune complex containing IgA in mesangium and causing local immune activation.~     Hydroxychloroquine reduces the activation of dendritic cells and the inflammatory process and~     showed the potential effect of treatment of patients with IgA nephropathy.~      The investigators study will recruite IgA nephropathy patients with proteinuria range from~     0.75 to 3.5g/d even after three-month treatment by sufficient ACEi/ARB. The patients were~     treated with Hydroxychloroquine 300-400mg/d according to eGFR. The proteinuria will recorded~     every two months and total four months. Then, the drug will be stopped for two months for~     observation of change of proteinuria.~   "
92821|NCT02352181|"~     In current practice, management of coagulation during liver transplantation is performed~     either through standard coagulation status or with ROTEM® depending on practitioner choice~     and availability of materials. In this context, the ROTEM® is used since over 2 years by~     anesthesiologists in the digestive surgery department of the Croix Rousse hospital in Lyon,~     France.~      Indeed liver transplantation surgery is at high risk of bleeding due to coagulopathy~     developed by patients who are eligible, due to coagulation factor synthesis deficiencies in~     the cirrhotic liver. On the other hand the standard coagulation profile is a poor reflection~     of coagulopathy in such patients because the imbalance between pro- and anti-coagulant~     factors are not taken into account by PT and aPTT measures. Management of intraoperative~     hemorrhage may be facilitated by the ROTEM® which is performed from whole blood and which~     allows the detection of abnormalities in the balance between pro- and anti-coagulant factors.~      This technique was already evaluated in liver, cardiac, and obstetric surgery but also in~     traumatology. Randomized trials in liver transplantation surgery have shown changes in~     transfusion practices but did not focus on the consequences of such changes.~   "
92822|NCT02352168|"~     The purpose of this study is to determine whether treating upper airway with intranasal~     corticosteroids in children with allergic rhinitis and no asthma may bring favors in reducing~     lower airway inflammation and improving small airway function.~   "
92823|NCT02352155|"~     Bleeding peptic ulcer is a common medical emergency. Endoscopic treatment stops bleeding in~     those actively bleeding from their peptic ulcers, reduces further bleeding, transfusion,~     surgery and deaths. After initial endoscopic control of bleeding, approximately 10% of them~     will develop recurrent bleeding. Mortality rate in this group of patients is at least 4 fold~     higher. In the few who need surgery, mortality approaches 30%. Prevention of further bleeding~     is therefore a major treatment objective. Currently the investigators use a high dose~     infusion of proton pump inhibitor (PPI) for 72 hours to render gastric pH neutral. In a~     previous randomized trial, the investigators showed that the rate of bleeding in 30 days was~     around 7% with such an approach. In a small subgroup of high risk patients defined by~     presentation with shock and ulcers > 2 cm in size, 1 in 6 would re-bleed. An alternate~     strategy is to select those at especially high risk of further bleeding and repeat endoscopic~     treatment the next morning. The investigators have shown that persistence of major bleeding~     stigmata, i.e. a visible vessel, during a second endoscopy predicts further bleeding. It is~     therefore logical that by repeating endoscopic treatment the next morning, the investigators~     can prevent further bleeding and possibly surgery and deaths. The current study proposes to~     develop a score to identify those at risk of further bleeding after endoscopy. The~     investigators used a historical cohort with carefully collected clinical data to derive a~     risk score. In this derivation phase of 939 patients, the investigators have developed a 9~     point risk score which consists of the following parameters (Age>60, Male sex, ulcer>2cm,~     posterior bulbar in location, spurting or Forrest Ia bleeding and admission hemoglobin of < 8~     g/dl). Using AUROC and Youden J statistics, a score of 5 or above has been shown to highly~     predictive of further bleeding. The score will then be validated in a prospective cohort of~     patients with bleeding peptic ulcers. In the final phase of this study, the investigators~     propose a randomized controlled trial to test the hypothesis that a second look endoscopy~     with treatment in selected high risk patients can further reduce bleeding and improve their~     outcomes. After endoscopic hemostasis to their bleeding peptic ulcers, patients are risk~     stratified based on the score. Those with a score of 5 or more are randomized to receive the~     standard treatment (a high dose PPI infusion) or a second look endoscopy with treatment in~     addition to PPI infusion. The primary outcome to the trial is further significant clinical~     bleeding.~   "
92824|NCT02352142|"~     The purpose of this proposal is to conduct a replication study of Family Nurture Intervention~     (FNI) at CHoNJ. FNI facilitates mother-infant interactions that are vital to early~     development. These include early and repeated mother/infant calming interactions during the~     NICU stay, such as interactive touch with vocal soothing, sustained reciprocal olfactory~     exposure and family practice in comforting, and systematically implemented skin to skin~     holding. This has already been studied at CHONY. Findings reveal that infants who receive FNI~     have significant increases in EEG power, a measure of brain activity, near to term age, when~     compared with those who receive Standard Care.~      There will be two groups; STANDARD CARE (SC) and INTERVENTION (FNI). In addition, 10 pilot~     subjects will be enrolled to train the staff involved in the procedures used in this~     Randomized Control Trial (RCT). The pilot patients will be enrolled identical to study~     patients and will be encouraged to participate fully. They will not be included in the~     analysis of the RCT.~      The STANDARD CARE group will receive current standard of care in NICU. The INTERVENTION~     group, in addition to the standard care, will receive the FNI intervention, which will be~     facilitated by our Nurture Specialists. In addition to the SC and FNI groups, there will be a~     third non-randomized group of infants born at term age who will receive standard care for~     newborns at CHoNJ. Assessments in the NICU will include physiological measures (ECG EEG),~     measures of maternal sensitivity through recorded mother-infant interactions and a variety of~     specimen collections (saliva, blood, and breast milk samples). The investigators will be~     conducting two follow up studies, at 4 months corrected age and at 12 months corrected age.~     The investigators will test the immediate and long-term effects of this approach to the~     development of preterm infants.~      The investigators hypothesize that this intervention will alter a wide range of indices of~     physiological regulatory capacities, and increase brain activity as measured by EEG (power~     and coherence) such that a brain activation pattern in the intervention group will be more~     similar to that of full term infants as opposed to the standard care group. Longer term~     indices of mother psychological and infant neurobehavioral outcomes will also be improved~     when assessed during the first few months of life.~   "
92825|NCT02352129|"~     : Fibrosis, in general, is a scarring process, which is characterized by fibroblast~     accumulation and excess deposition of extracellular matrix (ECM) proteins, which leads to~     distorted organ architecture and function. The contribution of fibrogenesis to impaired~     cardiac function is increasingly recognized. The fibrotic ECM causes increased stiffness and~     induces pathological signaling within cardiomyocytes resulting in progressive cardiac~     failure. Also, the excessive ECM impairs mechano-electric coupling of cardiomyocytes and~     increases the risk of arrhythmias. But today patient treatment and prognosis is based on~     ejection fraction quantification, QRS duration, and symptoms.~      Hypothesis: the increased level of fibrosis quantified using T1 mapping technique, compared~     with normal value, is of prognostic value in patient with dilated cardiomyopathies under~     optimal treatment.~      Methods: 330 patients are planned to be included and followed for 2 years~   "
92826|NCT02352116|"~     This study aims to assess the differences in overall pain severity, pain management, and~     satisfaction during recovery period between two groups of children who either receive or do~     not receive additional education related to expectation and management of postoperative pain.~   "
92827|NCT02352103|"~     To assess and compare the short-term post-operative continence recovery rate in two cohorts~     of men undergoing Robot Assisted Radical Prostatectomy (RARP), each randomized to undergo~     RARP with Vattikuti Institute technique or Retzius sparing technique.~   "
92828|NCT02352090|"~     The main objective of the study is to compare the metabolic effects of natural estradiol and~     synthetic ethinylestradiol used in combined oral contraception in healthy women. A~     progestin-only preparation will be used in comparison. The main goal is to study the effects~     on glucose metabolism, coagulation and a markers of chronic inflammation (such as hs-CRP).~     Our hypothesis is that the natural estradiol preparation will influence blood glucose levels,~     markers of coagulation and chronic inflammation less than the ethinylestradiol preparation.~     The progestin-only preparation will not effect these parameters.~   "
92829|NCT02352077|"~     The purpose of this study is to assess the safety and efficacy of NeuroRegen scaffold with~     bone marrow mononuclear cells (BMMCs) or mesenchymal stem cells (MSCs) in patients with~     chronic spinal cord injury.~   "
92855|NCT02351739|"~     Study of the Combination of ACP-196 and Pembrolizumab in Subjects With Platinum Resistant~     Metastatic Urothelial Cancer~   "
92830|NCT02352064|"~     Allogeneic stem cell transplantation was developed to cure many patients with hematological~     malignancies. It results in the development of graft versus host disease (GVHD) in 30-70% of~     cases. Chronic GVHD diagnosis currently uses biopsies of affected organs (skin, liver,~     gastrointestinal tract) and / or the observation of typical clinical signs sufficient for~     diagnosis. However, the anatomical sites for biopsy including the digestive tract are not~     clearly identified (high or low biopsy) and may present risks in their realization in~     particular in patients weakened by blood disease or immunosuppression.~      PET-CT with 18F-FDG has already been evaluated in chronic inflammatory diseases such as~     Crohns disease with good sensitivity and specificity. It interest in the graft against the~     host was studied in acute forms of digestive and allows lesion mapping and monitoring the~     effectiveness of treatment.~      Among patients with chronic GVHD scleroderma form, PET with 18F-FDG enabled to view~     musculoskeletal uptakes localized to the affected areas identified with MRI.~      The investigators propose a study evaluating the sensitivity and specificity of the~     examination by PET-CT with 18F-FDG in the diagnosis of chronic GVHD compared to conventional~     diagnostic tools.~   "
92831|NCT02352051|"~     The aim of this study was to evaluate and compare the effects of Atomoxetine(ATX) and osmotic~     release oral system-methylphenidate (OROS-MPH) therapies on executive functions, activities,~     treatment response time and adverse effects based on discernible clinical effects in children~     with combined type attention deficit-hyperactivity disorder (ADHD).~   "
92832|NCT02352038|"~     The aim of the study is to assess the effects of low-level laser therapy (LLLT) in patients~     with periodontitis during orthodontic-periodontal treatment for 12 months on the following~     aspects: (1) Effects on periodontal status; (2) Effects on alveolar bone remodeling; (3)~     Effects on cervical dentin sensitivity; (4) Effects on pain and quality of life.~      To eliminate any bias, the investigators will initially hypothesize that there is no~     difference in periodontal status, jawbone remodeling, tooth sensitivity, pain and quality of~     life in patients having teeth with chronic periodontitis and receiving LLLT with orthodontic~     treatment versus teeth undergoing orthodontic treatment without incorporation of LLLT.~   "
92833|NCT02352025|"~     The primary objective of this study is to determine if S-equol, an ER-beta agonist, is~     effective in decreasing the proliferation rate of triple negative breast cancer.~   "
92834|NCT02352012|"~     The purpose of this study is to determine whether injecting autologous blood or putting~     bronchial plug through bronchoscope is effective in the treatment of refractory pneumothorax.~   "
92835|NCT02351999|"~     The study is a prospective, multi-center, non-randomized single arm interventional~     investigation with the TSP Crosser Transseptal Access System, a new complete solution for~     transseptal puncture and left atrial access and catheter navigation, for patients with atrial~     fibrillation ablation referred for radiofrequency catheter ablation.~   "
92836|NCT02351986|"~     Background: Subacromial impingement syndrome (SIS) is a chronic and disabling disease,~     characterized by compression and mechanical abrasion of the tendons of the rotator cuff~     muscles, subacromial bursa and tendon of the long head of the biceps against the anterior~     surface of the acromion, coracoacromial ligament or the acromioclavicular joint during arm~     elevation movement. After the trauma, inflammatory processes initiate and may lead to loss of~     function when untreated. This inflammation leads the release of cytokines (IL-6, IL-10, IL-1β~     and TNF-α) whose acts as inflammatory mediators. Physical therapy works in treating SIS with~     the goal of reducing pain and inflammatory process. Cryotherapy is widely used in physical~     therapy by anti-inflammatory and analgesic effects, low cost, effectiveness and easy~     application. Objective: The aim of the study is to evaluate the effects of a cryotherapy~     protocol, applied on shoulder of subjects with SIS, on serum inflammatory mediators~     (cytokines) and local pressure pain threshold. Possible changes in function and pain will~     also be evaluated. Materials and Methods: 30 subjects will be selected and share in two~     groups, 15 healthy subjects and 15 subjects with SIS. Function assessments and quality of~     life will be held using the DASH and WORC questionnaires. Cryotherapy will be applied for 4~     consecutive days, lasting 20 minutes without interruption through ice pack over the shoulder~     of SIS carriers. For the blood samples, 20ml of blood will be collected at the first and last~     day of the intervention, and then stored at -80 ° C.~   "
92837|NCT02351973|"~     The purpose of this study is to determine whether the routine combination of optimal thiazide~     and K+-sparing diuretic will both increase efficacy of BP reduction and reduce risk of~     glucose intolerance; and whether K+-sparing diuretics alone may have a neutral or even~     beneficial effect upon glucose tolerance.~   "
92838|NCT02351960|"~     The purpose of this study is to evaluate the effectiveness of symptom control in~     gastroesophageal reflux disease (GERD) participants following treatment with dexlansoprazole.~   "
92839|NCT02351947|"~     The purpose of this research study is to improve methods for evaluation of brain changes~     during motor learning for patients with stroke, who have difficulty performing daily tasks~     with their arm and hand. The methods for evaluation of brain changes will consist of the~     combination of magnetic resonance imaging (MRI) and electroencephalography (EEG).~   "
92840|NCT02351934|"~     The purpose of this study is to find out if giving a medicine called furosemide, which is a~     diuretic or water pill, after colon surgery will safely shorten the patient's length of~     hospital stay.~   "
92841|NCT02351921|"~     This study will investigate how repetitive transcranial magnetic stimulation delivered as a~     protocol called 'continuous theta-burst stimulation (cTBS)' alters motor output and force~     control to a muscle in the forearm and touch perception in individuals with chronic,~     incomplete spinal cord injury. CTBS is a non-invasive technique that involved repetitive~     delivery of transcranial magnetic stimulation at a frequency of 30 Hz over the arm~     representation in the primary motor or sensory cortex. The purpose of this study is to~     determine whether cTBS is an effective intervention to increase motor output to a muscle and~     increase force control of that muscle and also improve the sense of touch.~   "
92842|NCT02351908|"~     The purpose of this study is to observe the safety of Truvada® (TDF/FTC) in relation to its~     impact on kidney function combined with different Integrase Inhibitors (Dolutegravir, or~     Elvitegravir/Cobicistat or Raltegravir), when given to patients who are commencing treatment~     for HIV infection for the first time.~      All three combinations (Raltegravir + Truvada®, Dolutegravir + Truvada® and Stribild®, a~     single pill which contains Elvitegravir/Cobicistat/Truvada®) are currently recommended by the~     national guide-lines and used in standard clinical practice.~   "
92844|NCT02351882|"~     Alzheimer's disease (AD) is commonly associated with behavioural changes such as agitation.~     Severe agitation is important to treat because it not only increases progression of AD and~     physical health problems (increased falls and weight loss), but it also decreases quality of~     life and increases caregiver stress. Currently prescribed treatments (i.e., antipsychotics)~     for agitation in AD do not work in everybody and when they do work the effect is small and~     they increase the risk of harmful side effects, including death. As a result, there is an~     urgent need for safer medication options. The cannabinoid nabilone can now be prescribed in~     capsule form for appetite and pain killing effects. Nabilone's calming effects may benefit~     those with agitation, and help the weight loss and untreated pain frequently associated with~     agitation. Through a clinical trial, the investigators hope identify the benefits of nabilone~     in the treatment of agitation in AD.~      The investigators objective is to determine whether nabilone is an efficacious and safe~     treatment for agitation, as well as having benefits for pain, weight and behavioural~     symptoms. This will be a 14 week clinical trial (participants take nabilone for 6 weeks,~     placebo for 6 weeks (order randomized) with 1 week between treatments). The investigators~     will assess and compare agitation, weight, pain, memory, behaviour and safety.~      Nabilone is a new class of medication that may be a safe and effective treatment for~     agitation in AD, with added benefits on appetite and pain. Reducing these symptoms would~     increase quality-of-life and reduce caregiver stress.~   "
92845|NCT02351869|"~     This study is a 7-day randomized, double-blind proof-of-concept pilot study of nitrous oxide~     vs. midazolam in 40 adults (20-60 years) with bipolar disorder (BD) (type I or II). Ongoing~     pharmacological and psychosocial treatments may continue, provided that they have not been~     initiated or significantly modified in the preceding 2 weeks. Participants' current treatment~     as prescribed by clinical psychiatrists will not be modified or interfered in this study. The~     study involves 3 visits. During study visit 1, participants will complete screening to ensure~     study eligibility. This will be done using interview measures. During study visit 2,~     participants will complete anthropomorphic measurements, measurement of endothelial function,~     screening blood work, ECGs, and an anaesthesia screener. During study visit 3, participants~     will receive the treatment (nitrous oxide or midazolam), complete an MRI scan, and complete~     interview measures and self-reports. There will be anthropomorphic measurements taken as~     well. The participant will be required to complete phone interviews and self-reports over the~     subsequent 7 days. There are 4 main predictions: 1. Nitrous oxide will significantly reduce~     depression symptoms vs. midazolam. 2. Nitrous oxide will significantly increase frontal~     cortical perfusion vs. midazolam. 3. Lower perfusion in frontal cortical regions at baseline~     will be associated with greater improvement in depression symptoms following nitrous oxide~     treatment. 4. Poorer endothelial function will be associated with greater improvement in~     depression symptoms following nitrous oxide treatment.~   "
92846|NCT02351856|"~     This is a rollover study designed to investigate the safety and effectiveness of~     investigational study drug ARRY-371797 in patients who previously received ARRY-371797 in a~     study for patients with LMNA-related dilated cardiomyopathy sponsored by Array BioPharma and~     may, in the Investigator's opinion, derive benefit from continued treatment.~   "
92847|NCT02351843|"~     The purpose of this study is to demonstrate the clinical feasibility of low amplitude~     electroconvulsive therapy (ECT) to reduce, and possibly eliminate the side effects of ECT by~     lowering the strength of the ECT stimulus from the conventional 800 mA to 500 mA. Low~     amplitude ECT could potentially reduce the risks associated with ECT while preserving its~     unparalleled efficacy. This novel development would remove key obstacles to allow for the~     wider adoption of ECT as a safe and effective therapy.~   "
92848|NCT02351830|"~     The EEU has proven effective in multiple studies evaluating various aspects of seasonal~     allergic rhinitis. All previous EEU clinical trials have utilized ragweed or grass pollen as~     the allergen of choice for dispersal, due to the local population, but many emerging~     treatments for allergic rhinitis are allergen specific, thus it is desirable to expand the~     repertoire of pollen selection for use in the EEU. Ragweed, grass and birch pollen have~     differing appearances and sizes but essentially, both have characteristics which promote the~     ability to keep the pollen grains suspended and hence, the ability to maintain proper~     concentrations within the EEU. Preliminary validation studies conducted in the EEU, absent of~     human volunteers, have confirmed our ability to release, disperse and maintain birch pollen~     concentrations in the EEU using the existing technology.~      This study aims to validate the use of birch pollen on a clinical scale. By adding non-~     allergic participants into the EEU, the investigators hope to determine if non-allergic~     persons exhibit differences at baseline in their epigenetic biomarkers from those who have~     pre-existing and established allergic airways inflammation.~   "
92849|NCT02351817|"~     The primary objective of the investigation is to explore the acceptance of a newly developed~     adhesive.~   "
92850|NCT02351804|"~     The purpose of this study is to investigate whether dexamethasone as an adjuvant to~     ropivacaine for adductor canal block increases duration of the sensory block, when~     controlling for a systemic effect using a paired design and bilateral blocks.~      The investigators hypothesize that adding dexamethasone to ropivacaine will prolong block~     duration compared with ropivacaine + placebo.~   "
92851|NCT02351791|"~     The primary purpose of the study is to investigate the impact that feces mixtures have on the~     peristomal skin when using a standard adhesive.~   "
92852|NCT02351778|"~     In study the investigators sought to~        1. Assess the quality of life experience in stable post stroke survivors in Pakistan and~          detail important factors influencing quality of life.~        2. Explore the association between primary care giver`s quality of life and stroke~          survivor's quality of life.~        3. To validate the quality of life tools and experience via in depth interviews and focus~          group discussion with the primary care giver of stroke patients to report the quality of~          life of the primary care giver.~   "
92853|NCT02351765|"~     The purpose of this study is to determine the recommended phase II dose, and to assess the~     safety of acelarin in combination with cisplatin in patients with locally advanced/~     metastatic biliary tract cancers.~   "
92856|NCT02351726|"~     Prospective, non-randomized, multicenter post-approval study to collect long term clinical~     and echographic data on Mitroflow DL patients.~   "
92857|NCT02351713|"~     Therefore, the purpose of this study is to compare the effectiveness of two exercise training~     programs for improving cardiorespiratory fitness: the ACE three-zone training model (i.e.,~     threshold based training) versus the more common ACSM recommended relative percent method~     (i.e., %HRR).~      It is hypothesized that:~        1. The ACE three-zone training model will elicit greater mean changes in cardiorespiratory~          fitness (as measured by VO2max) when compared to the relative percent method.~        2. Participants in the ACE three-zone training model group will be more likely to have~          favorable VO2max responses; while comparatively, participants in the relative percent~          method group would be more likely to experience a VO2max nonresponse to exercise~          training.~   "
92858|NCT02351700|"~     A randomized, double-blind, placebo-controlled intervention trial involving 100 treated~     subjects undergoing endonasal trans-sphenoidal (ENTS) resection of pituitary lesion. Subjects~     will be randomized into two groups: 50 treated in the opioid-sparing arm and 50 treated in~     the standard post-operative medication arm.~   "
92859|NCT02351687|"~     Children who recover from moderate acute malnutrition in Malawi remain at high risk for~     relapse or death in the year following recovery. This cluster-randomized trial will evaluate~     a package of affordable, safe, proven interventions specifically targeted to this population~     of children in an attempt to decrease their risk of relapse or death following recovery from~     moderate acute malnutrition. These children will be followed for a year following recovery to~     assess rates of relapse and mortality.~   "
92860|NCT02351674|"~     The trial is a single centre, retrospective cohort, non-interventional study to be conducted~     in the department of cardiology, Chinese PLA General Hospital, Beijing, China. To evaluate~     the link between mean perioperative clinical heart rate and short-term composite outcomes~     during PCI among local CHD patients.~   "
92861|NCT02351661|"~     The Nutrition Care In Canadian Hospitals study, conducted by the Canadian Malnutrition Task~     Force had the primary purpose of determining the prevalence of malnutrition in Canadian acute~     care hospitals. Secondary objectives were to determine the independent association of~     malnutrition with patient centred outcomes (e.g. length of stay) and describe the nutrition~     care processes for malnourished and well nourished patients.~   "
92862|NCT02351648|"~     To find out if a transitional care model can reduce the rate of unscheduled readmission to~     the Department of Internal Medicine (DIM) in SGH~   "
92863|NCT02351635|"~     The purpose of this study is to confirm the sensitivity and specificity of the BÜHLMANN fCAL™~     ELISA as an aid in diagnosis to differentiate between Inflammatory Bowel Disease (IBD;~     Crohn's Disease (CD), Ulcerative Colitis (UC), or indeterminate colitis) and Irritable Bowel~     Syndrome (IBS).~      To estimate the predictive value of a positive test (positive predictive value (PPV)) and the~     predictive value of a negative test (Negative Predictive Value (NPV)) using the proposed test~     outcomes for BÜHLMANN Calprotectin Test results when used in patients referred for diagnostic~     evaluation with signs and symptoms suggestive of either IBS or IBD.~      To confirm the inter-laboratory consistency of test results for the BÜHLMANN fCAL™ ELISA.~      To provide exploratory observations of test results in patients between the age of 2 and 21~     years.~      To provide a sample set from normal subjects with no symptoms or signs of gastrointestinal~     disease for use in Expected Value Testing.~   "
92864|NCT02351622|"~     The investigators are undertaking a multicentre, randomised controlled trial of 120 adults~     with newly diagnosed ITP from 5 medical centers in China. Part of the participants are~     randomly selected to receive caffeic acid tablets combining dexamethasone and the other part~     are selected to receive high-dose dexamethasone treatment. Platelet count, bleeding and other~     symptoms were evaluated before and after treatment. Adverse events are also recorded~     throughout the study.~   "
92865|NCT02351609|"~     Cigarette smoking is a significant health threat. To eliminate disparities in cancer burden,~     smoking rates must be reduced among populations where smoking is disproportionately~     concentrated: those with low socioeconomic status (SES). The investigators will apply two~     methods that are being used in the field of health disparities to the challenge of promoting~     smoking cessation among low SES smokers. These include: 1) Patient navigation; patient~     navigators are often lay persons, working as paid employees, who guide patients through the~     health care system and 2) Financial incentives; investigators propose to provide monetary~     incentives: $250 for smoking cessation within 6 months after study enrollment, and $500 for~     an additional 6 months of abstinence after the initial cessation. The investigators will~     recruit/randomize 352 smokers to a randomized controlled trial comparing the combination of~     Patient Navigation (delivered over 6 months) and Financial Incentives versus Enhanced~     Traditional Care control condition (smoking cessation brochure/list of cessation resources).~     The RCT will take place among adult daily smokers seen in the past year at BMC primary care~     practices, with a primary outcome of smoking cessation at one year. Follow-up by telephone,~     for both groups, will occur 6, 12, and 18 months after enrollment.~   "
92866|NCT02351596|"~     This study aims to determine if participation in a core stability physiotherapy group~     programme can improve the balance of children with cerebral palsy. It is hypothesised that~     teaching the children how and when to activate their deep core stabilising muscles may help~     improve their body awareness and their ability to control their alignment and therefore~     positively affect their balance. Children with cerebral palsy from the ages of 7 to 17, who~     can walk independently, will be randomly selected to join either the control group or~     intervention group, after completion of their baseline balance assessments. Each group will~     be re-assessed after completion of their 4 week intervention or control period.~   "
92879|NCT02351427|"~     The purpose of this study is to determine whether bortezomib is effective in the treatment of~     acute cellular rejection after kidney transplantation.~   "
92880|NCT02351414|"~     MPO is conducting this PMCF study to evaluate the safety and efficacy of its EVOLUTION® Total~     Knee Arthroplasty (TKA) components marketed in the EU. These types of studies are required by~     regulatory authorities for all devices that do not have medium to long-term clinical evidence~     available at the time of gaining approval to market in the EU. This study has been designed~     in accordance with MEDDEV 2.12/2 rev 2.~   "
92881|NCT02351401|"~     Patients can potentially monitor disease activity of rheumatoid arthritis (RA) through~     self-assessed swollen joints (clinical synovitis)joint counts but reliability of joint~     swelling is poor. The objective is to evaluate the use of education by ultrasound feedback on~     the ability of patients to assess for clinical synovitis swollen joints in RA.~   "
92867|NCT02351583|"~     Preeclampsia is a disease of pregnancy affecting 3% to 8% of all pregnancies and is a major~     cause of maternal and perinatal morbidity and mortality. Characterized by alter placentation~     with subsequent release of inflammatory mediators leading to a generalized endothelial~     dysfunction. It is now accepted that endothelial dysfunction heralds the clinical~     manifestations of preeclampsia.~      The side-stream darkfield (SDF) microscopy device emits a 550 nm green light with a depth~     region of interest of 500 um. Green light is absorbed by the erythrocytes and appears black.~     SDF is a well-known non-invasive tool that can study the microcirculatory changes. It was~     used before in many situations especially in sepsis and septic shock patients.~      Near-infra-red spectroscopy (NIRS) device, measures the absorbance of near-infra-red (NIR)~     light by tissues perfused with oxygenated blood, and is capable of measuring changes in~     parenchymal volume tissues. It was used before in many situations (including pregnant~     patients) to reflect the tissue oxygenations.~      The investigators are planning to use the SDF and NIRS tools to study the microcirculatory~     change in preeclamptic subjects and normal pregnant subjects. If these two devices are able~     to determine any changes this should stand as a baseline for future studies in this field.~   "
92868|NCT02351570|"~     By the health reform GKV in 2000 as well as by the competitive strengthening law GKV in 2007~     in §20 SGB V the health insurance schemes have received an enlarged action frame in the~     primary prevention and the operational health support.~      Through these paragraphs arises the possibility for citizens to let refund health-supporting~     programmes or health training of the health insurance schemes.~      Doctor's recommendation is one of the most important predictors by therapy decisions of~     patients.~      At the same time, primary prevention takes a very small part of the working hours of general~     practitioners.~      Hence, is the aim of the present study to examine whether and how general practitioners could~     be incorporated in the mediation of prevention's offers.~      To reach this aim, must be grasped first, to what extent general practitioners are already~     integrated into in the mediation of the primary prevention courses. There is up to now no~     information about whether general practitioners know about the GKV-improved prevention~     programmes for GKV-insured person and whether they are involved in their mediation. This~     research project will close this gap.~      The aims of the study are:~        1. to explore the roll of primary prevention in the general practitioner's consultation~        2. to analyse which social institutions are responsible for primary prevention according to~          the general practitioner's opinion~        3. to explore which primary prevention's programmes do general practitioners in their~          consultation recommend~        4. to analyse which factors play a role in the mediation~        5. to explore whether general practitioners with §20 are familiar.~      This is a mixed methods study which combines a mail survey of all general practitioners in~     Berlin with focus groups of 25 general practitioners.~      In this study all general practitioners of Berlin (n=1300) will be mailed. Participants for~     the focus groups are invited from the pool of teaching doctors of the Institute for General~     Medicine at the Charite.~      After both methods are analyzed on their own, the triangulation of the interpretation of both~     data sets will be done to find possible answers of the study questions. Bi-directionality of~     results will contribute to find possible interpretations of the survey responses in the~     results of the focus group discussions, as well as the results of the focus groups~     discussions could be explained by the results of the survey (Flick).~   "
92869|NCT02351557|"~     This study examines the effect of blood flow through the lungs and the body on the~     consumption and hence requirement of the anesthetic agent isoflurane.~   "
92870|NCT02351544|"~     According to the peripheral trigger theory of migraine headaches, nociceptive inputs from~     irritated or compressed cranial nerve branches can lead to neurovascular changes in the brain~     that cause migraine headaches. Advanced treatments aimed at deactivating the peripheral~     trigger points can be administered to patients who have failed medical management of~     migraines. Those accepted advanced treatments include botulinum toxin A injection in order to~     temporarily paralyze muscles causing nerve compression, and surgery to release those~     compression points permanently. An advantage of surgery is the ability to release~     non-muscular causes of nerve compression, such as fascial bands or intersecting arteries.~      Botulinum toxin A injection into trigger sites has been shown in multiple studies to be~     effective at reducing the frequency and severity of migraine headaches, and is a very~     commonly administered treatment for refractory migraines. It is approved by the FDA for the~     treatment of chronic migraines.~      Similarly, surgical decompression of trigger sites has previously been shown to have superior~     clinical outcomes to medical management, through a randomized, blinded controlled-trial~     performed at Case Western Reserve in 2009. Patients either received actual decompression of~     the trigger sites, or sham surgery (exposure and visualization of the trigger sites, without~     decompression). At one-year follow-up, the group who underwent actual surgery demonstrated a~     statistically higher proportion with significant improvement in their migraines (83.7% vs.~     57.7%, p=0.014), and with complete elimination of their migraines (57.1% vs. 3.8%, p<0.001).~     Several other reports have confirmed the good clinical outcomes of surgery demonstrated in~     this trial, and surgical decompression is now commonly performed by several surgeons around~     the United States.~      Prognostic factors predicting the success of surgical decompression in migraine headache~     treatment include older age of migraine onset, visual symptoms/aura, and 4-site~     decompression. Factors predicting failure of surgery include excessive operative blood loss,~     and surgery on only one or two trigger sites.~      One criticism of the studies on peripheral trigger decompression surgery for migraines has~     been that most of the results have originated from the same institution (Case Western~     Reserve), and from the same author (Guyuron). While several studies at other institutions~     have demonstrated positive outcomes of peripheral trigger decompression, these have only~     included a small number of patients.~      In addition, the sham surgery randomized-controlled trial has been criticized for not~     clarifying any prior treatments that patients had undergone before peripheral trigger~     deactivation, and for not showing how medication use patterns changed after surgery. Another~     criticism of that study was the fact that patients were examined by neurologists before the~     study but not after the study, and that surgery was performed on some patients with episodic~     migraines, who are known to not benefit from botulinum toxin. It is unclear what migraine~     types are most likely to benefit from surgical decompression.~      The investigators' goal is to perform a multi-center, prospective trial to demonstrate the~     effectiveness of peripheral trigger decompression in the treatment of migraine headaches,~     which would address the criticisms mentioned above. The main aim is to demonstrate that the~     positive results demonstrated by Guyuron et al are reproducible at other institutions and by~     other surgeons using similar techniques on different patient populations.~   "
92871|NCT02351531|"~     The aim of the study is to assess the hypoallergenicity of a new thickened extensively~     hydrolyzed formula.~   "
92872|NCT02351518|"~     Traumatic brain injury (TBI) affects 1.5 million patients per year in the United States,~     resulting in more than 50,000 deaths and more than 230,000 hospitalizations annually.~     Approximately 90,000 of these patients will suffer permanent impairment and more than half~     will experience short-term disability.~      Secondary injury processes play a critical role in the development of ischemia after trauma~     to the central nervous system and occur hours-to-days after the primary insult. Ischemia can~     lead to cerebral infarction or stroke. Ischemia has been described as the single most~     important secondary insult and has been identified histologically in approximately 90% of~     patients who die following closed head injury. Several factors resulting in post-traumatic~     cerebral ischemia have been identified: increased intracranial pressure (ICP), systemic~     arterial hypotension, and cerebral vasospasm. Cerebral vasospasm has been described as a~     sustained arterial narrowing. Clinically, the onset of new or worsening neurological symptoms~     is the most reliable indicator of cerebral vasospasm following a ruptured cerebral aneurysm.~     However, cerebral vasospasm is often unrecognized in patients suffering from moderate to~     severe TBI. These patients frequently have altered mental status due to the primary brain~     injury. In addition, they require narcotics for their pain and paralytics and/or sedatives~     while on a mechanical ventilator for airway protection. Thus, relying on the neurological~     exam to observe deteriorating neurological signs consistent with post-traumatic vasospasm~     (PTV) is reliable. While the etiology and outcome of patients with vasospasm secondary to~     ruptured aneurysm is well documented, the clinical significance of PTV after TBI is unknown.~     A better understanding of the role of cerebral autoregulation in the development of cerebral~     vasospasm could provide the answer. This proposal is for a pilot observational study~     describing the association of the impairment of cerebral autoregulation as measured by near~     infrared spectroscopy (NIRS) with the development of clinically significant vasospasm in~     patients with moderate to severe TBI. The information will serve as preliminary data for~     further study.~   "
92873|NCT02351505|"~     This phase II trial studies how well selinexor work in treating patients with small-cell lung~     cancer that has returned after a period of improvement. One specific way cancer cells~     continue to grow is by getting rid of certain proteins called tumor suppressor proteins:~     that would normally cause cancer cells to die. Selinexor works by trapping tumor suppressing~     proteins within the cell and may cause the cancer cells to die or stop growing.~   "
92874|NCT02351492|"~     Patients with gallstone disease should be checked whether a common bile duct (CBD) stone~     could be present. In case of a certain suspicion for CBD stones further investigations should~     be performed. This can either be done by magnetic resonance cholangio-pancreaticography~     (MRCP) or by intraoperative cholangiography. The study investigates which pathway would be~     favorable in regard of an early hospital demission.~   "
92875|NCT02351479|"~     A six-month interventional program to determine the biological and psychosocial effects of~     hula as a form of physical activity for female breast, cervical, endometrial or ovarian~     cancer survivors living on Oahu.~   "
92876|NCT02351466|"~     The investigators have previously studied a group of young children with T1D using brain MRI,~     age-appropriate neurocognitive testing and continuous glucose monitoring, followed for 18~     months. The investigators observed significant differences in gray matter volumes and white~     matter microstructure in the children with diabetes as compared to controls. These~     differences appeared to increase over time, with slower rates of brain growth in the T1D~     group (Mazelli, et al, Diabetes 2014; Barnea-Goraly, et al, Diabetes Care 2014; Mauras, et~     al, Diabetes 2015). In this new protocol the investigators will include the same children~     with T1D and healthy controls previously studied and recruit new similar subjects to replace~     those lost by attrition. The investigators will be using structural and functional brain MRI,~     neurocognitive testing and measures of glycemic control, to determine if changes in the brain~     persist or worsen over longitudinal follow up, and whether these changes are associated with~     measures of glycemic control and neurocognitive metrics as these children grow and progress~     through puberty.~   "
92877|NCT02351453|"~     The primary objective of AID study is to identify the medico-neuropsychological,~     socio-economic and environmental baseline characteristics of dyads associated with the~     institutionalization of AD patients.~   "
92878|NCT02351440|"~     The objective of this study is to determine the effect of preoperative duloxetine on~     postoperative quality of recovery after ambulatory surgery, specifically laparoscopic~     gynecological surgery.~   "
92883|NCT02351375|"~     This study will explore whether the IntelliCap® system can be used to study the human~     microbiota composition in the small intestine. The IntelliCap® system is an oral drug~     delivery and patient monitoring system consisting of a capsule-shaped device and ancillary~     equipment. The IntelliCap® capsule is also able aspirate fluid from its environment. Here, we~     explore whether the capsule is able to take a fluid sample from the lumen of the~     gastrointestinal tract for microbiota analysis. To study this, a controlled dietary~     intervention that is expected to induce a temporary change in microbiota composition will be~     performed in healthy volunteers. Microbiota composition of samples collected from the small~     intestine using the IntelliCap® system will be compared to fecal samples from the same~     individuals collected at the same time point.~   "
92884|NCT02351362|"~     Given there is substantial loss to follow-up soon after delivery among HIV-positive pregnant~     women in South Africa, we will conduct a pilot study of an innovative approach to improve~     retention in care targeted to this specific population at high risk of drop-out. The problem~     of poor retention in care is well documented, but interventions to address the issue are~     lacking. In order to design an effective intervention that will be tested in a future~     randomized controlled trial, we will first complete preliminary research via a pilot study in~     order to determine the feasibility and acceptability of an incentive program (i.e., a~     supermarket voucher) to reduce loss to follow-up among HIV-positive women after delivery.~      The primary objective of this study is to determine the feasibility of a voucher incentive~     intervention aimed at improving retention in postpartum HIV care~      Secondary objectives include: a) to determine the efficacy of the intervention at increasing~     postpartum retention; b) to determine the acceptability of the intervention in terms of~     women's preferences for the intervention compared to other possible interventions; c) to~     assess differences in patient retention among women newly diagnosed with HIV vs. those who~     knew their HIV-positive status before pregnancy; and d) to assess differences in patient~     retention among women who initiated ART during pregnancy vs. those who were on ART before~     becoming pregnant.~      We will enroll up to 200 adult (≥18 years), pregnant, HIV-positive women attending antenatal~     care who have not previously enrolled in the study at Hikhensile Clinic, Johannesburg, South~     Africa. The study will be a prospective intervention cohort study with historical controls.~     Intervention subjects will receive a one-time supermarket voucher of R50 (about $5.00) for~     participants who return for at least one postpartum visit at the study clinic within 10 weeks~     of delivery.~   "
92885|NCT02351349|"~     Chronic kidney disease is a common diagnosis in the elderly population and it is associated~     with significant morbidity and health care costs. The prevalence rates increase with age to~     about 40% for adults aged > 65 years. In the elderly population (age 65 and over), CKD is~     associated with a higher burden of comorbid conditions and frailty. The prevalence of frailty~     is higher in CKD patients with rated being double in early stages and nearly 6 times higher~     beyond stage 3b. Previously reported frailty mortality rates of 18% at 3 years and 47% at 7~     years comparing with mortality rates in non frail individuals of 3% and 12% respectively. In~     this study, the investigators investigate the effect of multidisciplinary interventions upon~     frail elderly patients with CKD not yet on dialysis. This interventions include best medical~     care, nutrition, physiotherapy, and social, psychological and spiritual support.~   "
92886|NCT02351336|"~     If the investigators could prove that three -dimensional ultrasound measurement of fetal~     adrenal gland volume can accurately predict the likelihood of preterm birth in patients~     having symptoms and signs of PTL , they would be able to use it as a valuable component for~     assessment and early management of high risk pregnant women for PTB which can be positively~     reflected on the risk of neonatal morbidity and mortality in those patients.~   "
92887|NCT02351323|"~     Over the past two decades, type 2 diabetes mellitus (T2DM) has emerged from relative~     obscurity to become one of the most serious complications of obesity in Hispanic obese~     populations, especially among those with a family history of T2DM. Few therapies have~     demonstrated long term efficacy in combating obesity and risk of T2DM in youth. Given the~     emerging evidence that glutamine and leucine (building blocks of protein) may affect energy~     partition and thus diabetes risk, and that the relationship of glutamine and diabetic risk~     has been further evaluated in one adult observational cohort study but data on leucine are~     lacking, we plan to conduct a clinical trial to determine the efficacy of glutamine to reduce~     insulin resistance, a diabetes risk factor.~      The primary specific aim of the research plan is to conduct a randomized, double-blind,~     placebo controlled, clinical trial to test the efficacy of 6 months supplements of glutamine~     in reducing biomarkers for insulin resistance and weight gain among 56 obese Hispanic~     adolescents age 12-19 years with a BMI at or above the 95th percentile and a family history~     of T2DM. At the end of the grant period, we will have obtained preliminary data to plan~     pivotal clinical trials of glutamine coupled with or without lifestyle changes.~   "
92888|NCT02351310|"~     This is a randomized prospective clinical study that will evaluate the effects of antenatal~     corticosteroid administration (ACS) vs. placebo in singleton pregnancies who are threatening~     to deliver prematurely between 22 0/7 and 23 6/7 weeks on admission with the goal of~     improving composite neonatal mortality and morbidity.~   "
92889|NCT02351297|"~     This study aims at evaluating the consequences of a 3 weeks high protein diet on the large~     intestine ecosystem (microbiota, metabolites and gene expression in rectal mucosa). Those~     parameters will be analysed with technics including OMICs methods. After a run-in period, 42~     volunteers will receive either soy or milk protein or maltodextrin as a placebo control. This~     trial is double blind randomized placebo-controlled paralleled design (3 arms). Longitudinal~     sampling will allow the comparison of parameters during the study.~   "
92890|NCT02351284|"~     To determine the prevalence of hypovitaminosis D in HIV infected patients, and the~     consequences on secondary hyperparathyroidism, and bone mineral density (BMD). Also, to~     establish the improvement in vitamin D status, parathyroid hormone (PTH) and BMD, in case of~     receiving vitamin D supplementation, during a follow up period of at least 1 year.~   "
92891|NCT02351271|"~     The aim of the study is to demonstrate the performance and safety of the Femtosecond~     laser-assisted anterior capsulotomy and lens fragmentation on human eyes using the FEMTO LDV~     Z8 compared to conventional technique in cataract surgery.~   "
92906|NCT02351076|"~     The aim of the study is to compare correlation for right to left shunts (mainly patent~     foramen ovale) detection for three methods-transesophageal echo as a gold standard,~     transcranial doppler with contrast agent (microbubbles) and new method- Flow detection system~     ( Cardiox TM) in young stoke patients ( age under 55 years).~   "
92907|NCT02351063|"~     HABIT-II is a feasibility study aimed at home monitoring of patients with heart failure.~     B-type natriuretic peptide (BNP) has strong correlations to the severity of heart failure.~     Lower BNP levels are closely associated with better clinical outcomes. The goal of HABIT-II~     is to demonstrate that the results of daily patient self-testing of BNP at home will provide~     sufficient information to guide physicians to modify therapy and lower BNP levels over time.~   "
92892|NCT02351258|"~     The overall goal of this Community Central Line Infection Prevention (CCLIP) trial, supported~     by grant R01 HS022870 from the Agency for Healthcare Research and Quality, is to determine~     whether use of a promising new intervention, namely 70% isopropyl alcohol embedded protective~     caps on central lines, in the home setting is associated with a reduction in ambulatory~     central line-associated bloodstream infections (CLABSI) in a high-risk population of~     pediatric hematology/oncology patients. Despite successes in CLABSI reduction efforts for~     inpatients, it remains unknown what generalizable best practices should be with chronic~     central lines in the home setting and how effective involving patients and caregivers across~     multiple institutions in CLABSI reduction efforts will be. This research will involve a~     cluster-randomized, cross-over design, clinical trial. This proposal will focus on the~     caregivers integral to ambulatory pediatric central line care: patients and families. The~     specific aims of the proposed research program are:~      Specific Aim #1: Evaluate whether use of 70% isopropyl alcohol embedded protective caps on~     central lines reduces the rate of CLABSI in ambulatory pediatric hematology/oncology~     patients.~      Hypothesis: Use of 70% isopropyl alcohol embedded protective caps on central lines will be~     associated with at least a 25% reduction in the ambulatory CLABSI rate for pediatric~     hematology/oncology patients.~      Specific Aim #2: Evaluate whether use of 70% isopropyl alcohol embedded protective caps on~     central lines reduces the rate of all positive blood cultures in ambulatory pediatric~     hematology/oncology patients.~      Hypothesis: Use of 70% isopropyl alcohol embedded protective caps on central lines will be~     associated with at least a 25% reduction in the positive blood culture rate at home for~     pediatric hematology/oncology patients.~      Specific Aim #3: Evaluate whether the use of 70% isopropyl alcohol embedded protective caps~     on central lines changes the distribution of bacteria isolated from blood cultures of~     pediatric hematology/oncology patients.~      Hypothesis: Use of 70% isopropyl alcohol embedded protective caps on central lines will~     reduce Gram-positive CLABSI, secondary blood steam infections, and single positive blood~     cultures at home for pediatric hematology/oncology patients.~   "
92893|NCT02351245|"~     Lip hemangiomas are at higher risk than those located in other sites. However, studies about~     clinical characteristics of lip hemangiomas have not been enough. The investigators want to~     conduct a prospective study on the clinical features of lip hemangiomas.~   "
92894|NCT02351232|"~     A randomized placebo-controlled clinical trial investigating the effects of Liraglutide as an~     add-on to intensive insulin therapy in overweight insulin pump treated type 1 diabetes~     patients in suboptimal glycemic control.~   "
92895|NCT02351219|"~     The study is conducted as a monocentric prospective phase II trial. Patients with~     unresectable stage III locally advanced pancreatic cancer (defined for extended encasement of~     superior mesenteric artery/celiac axis/hepatic artery or for combined venous and arterial~     involvement or for unreconstructible venous encasement), ECOG PS 0-1 and age 18-75 are~     eligible.~      After multidisciplinary evaluation of resectability, treatment with FOLFOXIRI is provided for~     a maximum of 12 cycles with multidisciplinary evaluation of disease status every 4 cycle.~      In case of tumors have deemed resectable surgery is considered. In case tumors remain~     unresectable, radiotherapy is evaluated after the end of chemotherapy.~      Primary objective of the study is the rate of patients who become resectable and undergo~     radical surgical resection after chemotherapy.~      Secondary objectives are: response rate, progression-free survival, overall survival,~     toxicity.~   "
92896|NCT02351206|"~     As low back pain (LBP) imposes a heavy socioeconomic burden, early detection of pathologic~     intervertebral disc change in young adults holds high clinical relevance as a common~     structural cause of LBP. The investigators therefore assessed the feasibility of using X-ray~     disc space height measurements as a predictive evaluation method of lumbar disc herniation~     (LDH) and degeneration in LBP patients in their early 20s.~   "
92897|NCT02351193|"~     While practicing the different assisted reproductive techniques, the investigators are faced~     daily by the problem of poor responder females, and the debate about predicting its results~     based on the outcome of the different ORTs used. Due to the cost of AMH as an indicator for~     ovarian response, the need to re-assess its role was essential in our community, which led us~     to conduct this prospective multi-center IVF study.~   "
92898|NCT02351180|"~     The purpose of this study is to determine if the use of inhaled beclomethasone after a~     community-acquired respiratory viral infection in a lung transplant recipient decreases the~     risk of the subsequent development of chronic lung allograft dysfunction.~   "
92899|NCT02351167|"~     The investigators' goal is to identify the most appropriate smoking cessation treatments for~     smokers based on genetic information. Smokers try to quit smoking but relapses are common.~   "
92900|NCT02351154|"~     Atrophic gastritis (AG) is a chronic disease, associated to gastric adenocarcinoma moreover~     if severity AG is present. Sydney system classified AG as mild, moderate and severe, but with~     moderate interobserver agreement, due to this system is based in a visual analogic scale~     (qualitative analysis). Confocal endomicroscopy showed an accuracy of 98% for diagnosis~     gastric diseases, but when grading AG still remains a qualitative measure. Recently, a new~     software called Cellvizio® Viewer (CV) permits to measure in micrometers (µm) the~     structures observed after confocal laser endomicroscopy probe studies. Based on the~     hypothesis that AG severity is correlated with crypts size diminution, the aim of this study~     is to determine a quantitative way to classify the severity of AG measuring the crypt area~     and inter-crypt spaces in patients with AG.~   "
92901|NCT02351141|"~     The investigators will apply 129Xenon and/or 3He image acquisition and analysis methods in~     120 asthma patient volunteers in order to characterize and probe the relationship between~     lung structure and function using imaging.~   "
92902|NCT02351128|"~     The purpose of this trial is to evaluate the efficacy of lanreotide on locally evolving~     and/or metastatic MCC in a national prospective multicentre phase II study (centres belonging~     to the skin cancer task force of the French Society of Dermatology namely Groupe de~     Cancérologie Cutanée de la Société Française de Dermatologie). This one-arm study, for which~     the primary endpoint is overall response to lanreotide, will follow an A'Hern plan in one~     step (A'Hern RP. Sample size tables for exact single-stage phase II designs. Stat Med 2001,~     20:859-66) with main evaluation at 12 weeks on a population of 35 patients. The investigators~     make assumption that a 40% success rate at 3 months would be desirable, but if it was 20% or~     less the treatment would be unacceptable. It gives a trial size of 35 patients with a cut-off~     of 12 patients. Over 12 patients lanreotide will be considered as effective.~      The lanreotide treatment (Somatuline LP 120 mg injected subcutaneously every 28 days) will be~     provided by IPSEN Pharma laboratory. An ancillary immunohistochemistry study on somatostatine~     receptors 2,3,5, dopamine receptors 1,2 and polyomavirus MCPyV will bring new data on this~     neuroendocrine tumour and potentially provide new therapeutic perspectives.~      The results of this study may :~        -  determine whether somatostatin analogues may help to treat locally advanced and/or~          metastatic MCC;~        -  address whether there is a correlation between positive SPECT-CT (octreoscan) assessment~          and therapeutic response to lanreotide;~        -  evaluate the place of TEP-CT and SPECT-CT for MCC evaluation/staging;~        -  evaluate in future studies, with the ancillary data, other analogues or hybrid~          molecules;~        -  consider, if positive results are obtained from this study, somatostatin analogues as~          adjuvant treatment after surgery of primary MCC.~   "
92903|NCT02351115|"~     The purpose of this study is to determine whether people who usually have photosensitive~     epilepsy will show a reduction in epileptic activity when they take a single dose of Staccato~     Alprazolam as compared to placebo.~   "
92904|NCT02351102|"~     The purpose of this study is to determine whether Valacyclovir treatment, administered during~     pregnancy after proven primary maternal Cytomegalovirus (CMV) infection, reduces fetal~     transmission rates and prevents fetal injury in cases of fetal infection.~   "
92905|NCT02351089|"~     The aim of the current Project is to study the efficacy of a probiotic Product in reducing~     the symptoms of gastrointestinal toxicity linked to the irradiation of gynecologic cancer.~   "
92908|NCT02351050|"~     The aim of the project is to demonstrate a fibrinolytic effect of sonothrombolysis (continual~     transcranial Doppler monitoring) using 2 MHz diagnostic probe on the reduction of risk of~     brain infarctions due to the activation of endogenous fibrinolytic system during angioplasty~     and stenting of coronary arteries. 120 patients indicated for coronary angioplasty and~     stenting will be enrolled into the study in order to demonstrate a twenty-percent risk~     reduction of number and volume of brain infarctions detected using MRI examination 24 hours~     after cardiac endovascular treatment in 5% level of significance. Patients will be randomized~     - subgroup 1 will undergo a 40-240 minute non-diagnostic TCD monitoring during endovascular~     procedure, subgroup 2 will undergo interventions without TCD monitoring.~      Confirmation of our hypothesis that sonothrombolysis is able to activate endogenous~     fibrinolytic system during coronary angioplasty and stenting with consecutive reduction of~     the number and volume of brain infarcts, can lead to the increase of the safety these~     patients. We can presume that up to 50% of patients indicated for endovasular heart treatment~     can be treated using these methods in the future.~   "
92909|NCT02351037|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of ibrutinib~     alone or in combination with either cytarabine or azacitidine in the treatment of subjects~     with Acute Myeloid Leukemia (AML) who have failed standard treatment, or subjects without~     prior therapy who refuse standard chemotherapy.~   "
92910|NCT02351024|"~     The Sponsor is developing a new form of naproxen (the study drug, OXP005), for the potential~     treatment of rheumatic and painful conditions. The study will compare the study drug to an~     already marketed formulation of prescription strength naproxen (Naprosyn® the reference~     product) by looking at how a single dose of the drug is taken up by the body. The safety and~     tolerability of the drug will also be assessed.~   "
92911|NCT02351011|"~     Osteoarthritis (OA) is one of the most common forms of arthritis. It is a lasting condition~     in which the material that cushions the joints, called cartilage, breaks down. This causes~     the bones to rub against each other, causing inflammation, stiffness, pain and loss of joint~     movement. Currently, there are few effective treatments available for patients suffering from~     OA.~      Mesenchymal stem cells (MSCs) are cells that have the ability to self-regenerate, which means~     they have the ability to make copies of themselves and to turn into other kinds of cells~     (e.g. cartilage cells). Stem cell science shows much promise for the future treatment of~     osteoarthritis, but much of the research is still in the early stages. In this study,~     researchers want to determine the safety of MSCs that a patient can tolerate without causing~     side effects. This will be done by starting at a low dose of MSCs and moving on to the next~     higher dose level provided there are no safety concerns. Researchers will also be looking at~     the function of the knee over time, which may give them some insight on the usefulness of~     MSCs as a treatment option.~   "
92912|NCT02350998|"~     This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with~     bilateral middle ear effusion requiring tympanostomy tube placement. Eligible subjects will~     receive a single dose to each ear of 6 mg OTO-201, administered intraoperatively into the~     middle ear through the lumen of the tympanostomy tube (trans-tympanostomy tube TTT). The~     study is designed to characterize safety and any procedural issues associated with TTT drug~     administration of OTO-201.~   "
92913|NCT02350985|"~     The presented study aims to compare effectivity of propranolol with effectivity of~     venlafaxine in escalating dose in subjects with vestibular migraine (VM) over a period of 12~     weeks. The study population consisted of subjects diagnosed definite VM according to criteria~     of Bárány Society and Migraine Classification Subcommittee of the International Headache~     Society (IHS). Effectivity of therapy was measured by Dizziness Handicap Inventory (DHI),~     number of vertiginous attack of last month and visual analogue scale (VAS) reported dizziness~     related Quality of Life (QOL). Beck Anxiety Inventory (BAI) and Beck Depression Inventory~     (BDI) were also used to determine psychiatric improvement played role in response to therapy~     in venlafaxine treatment arm.~   "
92914|NCT02350972|"~     In patients with multiple metastatic nodules of melanoma, the investigators evaluated whether~     autologous cytokines injected into cutaneous metastases would induce a systemic immune~     response as evidenced by the accumulation of dense lymphocytic infiltrates in metastases that~     had never been injected. Such immune responses were observed, and often the never-injected~     metastasis regressed completely. 20% of patients remained free of disease for greater than 5~     years.~   "
92915|NCT02350959|"~     The present study is intended to assess the vulnerability of plaques seen on CCTA by means of~     TVC Imaging System and to make comparisons between plaques with adverse plaque~     characteristics and ones without adverse plaque characteristics in terms of plaque volume and~     lipid core contents.~   "
92916|NCT02350946|"~     The purpose of this study is to shed light on the basic neurobiological mechanisms which~     underlie social information processing in healthy men. More specifically, we intend to~     examine whether a person's social competence level is related to the patterns of neural~     activity and his visual search strategies during evaluation of social scenes. Furthermore, it~     will be assessed whether an oxytocin-driven increase in activity in brain areas relevant to~     the task will facilitate social information processing and thus enhance task performance.~     Additionally it will be examined whether oxytocin can facilitate response inhibition in an~     emotional context.~   "
92917|NCT02350933|"~     The purpose of this study is to determine whether possible damages of the trachea caused by a~     prior prolonged intubation (> 24h) can be observed by rigid endoscopy of the trachea and if~     cuffed tracheal tubes cause less damages than cuffed tubes.~   "
92918|NCT02350920|"~     Over 18,000 Irish people are affected by the inflammatory bowel diseases (IBD), Crohn's~     disease and ulcerative colitis. These illnesses often arise at a young age and can be~     associated with significant physical disability. In addition, there is considerable~     psychosocial disability associated with IBD. Previous studies have suggested that simple~     psychological interventions may be valuable in improving quality of life and may even improve~     disease activity. However, there has been no comprehensive trial to determine the precise~     effect of psychological interventions on quality of life (QOL), stress or disease activity.~     Our aim is to conduct a randomised controlled trial of a simple psychological intervention to~     determine it's effect on QOL and stress~   "
92933|NCT02350725|"~     The purpose of this pilot study is to investigate the pharmacodynamic and pharmacokinetic~     parameters of a novel furosemide formulation administered subcutaneously as compared to oral~     furosemide.~   "
92919|NCT02350907|"~     The purpose of this study is to develop a laboratory-based assay that will be a real-time PCR~     test to detect the organism N. gonorrhoeae and its most important genetic markers of~     antimicrobial resistance. This study will also determine factors associated with gonorrhoea~     and describe sexual behaviours of men who have sex with men, to inform parameters for a~     mathematical model of gonorrhoea transmission and antimicrobial resistant gonorrhoea.~   "
92920|NCT02350894|"~     This study examines the possible microstructural changes in the brain during recovery after~     mTBI using diffusion MRI.~   "
92921|NCT02350881|"~     Foot silicone implants suffer from bad reputation on the market, due to poor results obtained~     with the first generations of implants. Allergies to silicone, infections due to silicone and~     implants breakage used to be common with previous generations of silicone implants.~     Publications relative to those implants showed that the survival rates after 5 years of~     follow-up were unsatisfactory.~      Since 1998, Tornier has been selling a new generation of silicone implants made of Ultrasil™.~     The use of this new material in its manufacturing process together with its innovative~     geometry, make the Primus™ FGT a much more resistant, anatomic and long lasting implant.~      The main objective of this study is to evaluate the clinical outcomes of the implantation of~     Primus™ FGT implant in great toe arthroplasty. The study will capture long term outcomes in~     terms of functional metrics from documented clinical data. Other objectives are to evaluate~     the outcomes in terms of radiological evaluation and of safety during all the follow-up.~   "
92922|NCT02350868|"~     The Dose Escalation Phase will determine the MTD of MPT0E028 and evaluate its safety and~     tolerability, PK, PD, and preliminary clinical effects; the subsequent Dose Confirmation~     Phase will be a cohort expansion at or below the MTD (i.e., an RP2D) of MPT0E028.~   "
92923|NCT02350855|"~     The main aim of the study is to assess the effectiveness of tailored nutritional intervention~     in delaying the progression of cachexia to refractory cachexia in adult female cancer~     patients.~      The tested hypothesis stated that intake of nutrient rich bread mix (along with dietary and~     physical activity counselling) for six months, improved the anthropometric and biochemical~     indices in free-living patients suffering from cancer cachexia.~   "
92924|NCT02350842|"~     Cardiac resynchronization is a recommended therapy for patients with advanced heart failure,~     under optimized medical treatment with reduced left ventricular ejection fraction and~     prolonged QRS, nevertheless, still 30% of the population do not respond to standard~     biventricular implantation.~      Non-response can be explained by a combination of factors including sub-optimal patient~     selection, placement of the pacing lead over a zone of slow conduction, insufficient~     correction of mechanical dyssynchrony including sub-optimal lead implantation. Few data~     distinguish true non-responders from patients in which effective resynchronization was not~     delivered through standard biventricular implantation.~      Triple-site cardiac resynchronization pacing (stimulation at three ventricular sites) has~     been proposed to improve synchrony and thus the response rate in (Cardiac Resynchronisation~     Therapy) CRT recipients.~   "
92925|NCT02350829|"~     Diffuse fibrosis (or scarring) of the heart muscle is found in a variety of congenital heart~     diseases and in cardiomyopathies (heart muscle disease), and is considered a mediator of~     decreased cardiac function. The detection and quantification of diffuse myocardial fibrosis~     has recently become feasible non-invasively, using cardiac magnetic resonance (CMR), applying~     a new technique labeled T1 mapping. With this technique, the part of the heart tissue which~     is not made up of muscle cells (extracellular volume) can be quantified, as long as the~     individual's hematocrit (cellular volume in the blood) is known. The extracellular volume in~     the heart tissue is regarded as a quantifiable marker for the extent of diffuse myocardial~     fibrosis.~      In the proposed study this new T1 mapping technique shall be applied in patients with~     different forms of congenital heart disease (n=130), cardiomyopathies (n=40) and in control~     subjects (n=30). The additional scan time due to participation in the study will be~     approximately 5-10 minutes, without changing the clinical protocol.~      The main objective is to study the presence and extent of myocardial fibrosis by T1 mapping~     CMR in pediatric patients with congenital heart disease and cardiomyopathies, in comparison~     to cardiovascularly healthy controls.~   "
92926|NCT02350816|"~     This extension study will allow participants to continue receiving treatment with HGT-1410~     and to initiate treatment in patients who received no-treatment in Study HGT-SAN-093, and~     will evaluate the long-term safety and efficacy of the study drug.~   "
92927|NCT02350803|"~     patients were enrolled by the inclusion criteria and were undergo lefort 1 maxillary~     osteotomy. after the latency phase the distraction was done in anterior- posterior vector.~     patients were divided by randomized allocation in 2 groups. in group 1 the distractor was~     removed after consolation phase, and in group 2 fixation devices were placed immediately~     after removal of distractors. data regarding relapse were analyzed by lateral cephalogram~     X-ray taken in 3 different phases of the trial. change of occlusal plane and the A point of~     the cephalometric analysis were determined as reference point of the study.~   "
92928|NCT02350790|"~     Patients who are planning to undergo laparoscopic surgery for endometriosis will be assigned~     to either ablation or excision of endometriosis. The investigators think that patients who~     have excision of endometriosis will have greater relief of pain.~   "
92929|NCT02350777|"~     The purpose of this study is to see if giving the patient stem cells their original donor~     (boost) after removing the T cells (T cell depleted- TCD boost) without further chemotherapy.~     The investigators want to see if this can improve bone marrow function. This would also~     improve the patients white blood counts, red blood counts and platelets. This may make the~     patients chances of improving and surviving better. The investigators will also be looking at~     the short term side effects and risks of the TCD boost.~   "
92930|NCT02350764|"~     The purpose of this study is to closely examine tumor and blood samples from patients treated~     with nivolumab and ipilimumab in order to try to identify why some patients with lung cancers~     respond and why some patients do not.~   "
92931|NCT02350751|"~     The purpose of this study is to evaluate the safety and pharmacokinetics of MEDI8852 compared~     to placebo when administered to healthy adult subjects.~   "
92932|NCT02350738|"~     This study evaluates the effects of Multimodal Cognitive Enhancement Therapy (MCET) for~     people with mild cognitive impairment and early stage dementia by a randomized, controlled~     (mock-therapy), double-blind, cross-over trial~   "
92934|NCT02350712|"~     The purpose of this study is to test a study drug called patritumab. Patritumab may work when~     combined with other medications that are approved in the UK for treating Squamous Cell~     Carcinoma of the Head and Neck (SCCHN), called cetuximab, cisplatin or carboplatin. It is~     hoped that patritumab may have some benefit in treating patients with cancer. This study will~     help identify how much patritumab can be given in combination with cetuximab, and cisplatin~     or carboplatin. This study will show how safe and how well tolerated patritumab is when these~     medications are given together.~   "
92935|NCT02350699|"~     To use the Nautilus BrainPulse to compare and contrast the signal patterns from this cohort's~     signal patterns with those of concussed high school athletes.~   "
92936|NCT02350686|"~     Phase II study of second line capecitabine plus oxaliplatin (XELOX) in patients with advanced~     biliary tract carcinoma after failure of gemcitabine-based chemotherapy.~   "
92937|NCT02350673|"~     This is an open-label, multi-center, Phase Ib clinical study of cergutuzumab amunaleukin, in~     combination with atezolizumab, to investigate the safety, pharmacokinetics, and therapeutic~     activity in participants with locally advanced and/or metastatic carcinoembryonic antigen~     (CEA)-positive solid tumors, whose disease has progressed on or who are intolerant to the~     standard of care therapy. Enrolled participants who continue treatment will be treated until~     loss of clinical benefit, unacceptable toxicities, or withdrawal of consent. The study will~     include 2 parts: a dose-escalation Part I and a dose expansion Part II. The anticipated~     treatment period is 24 months for both cergutuzumab amunaleukin and atezolizumab and may be~     modified if emerging data suggest a benefit.~   "
92938|NCT02350660|"~     Pilot study to assess the effect of oral immunotherapy on specific IgE levels and antigen~     consumption in two distinct food allergies.~   "
92939|NCT02350647|"~     Patients will be randomized to receive HEALICOIL™ REGENESORB (the study anchor) or TWINFIX~     Ultra HA, a similar comparative product, for use in the repair of their shoulder injury. They~     will be asked to complete questionnaires throughout the study and will receive an MRI, CT and~     multiple ultrasound images. The MRIs and radiographs will be used to assess bony ingrowth at~     the repair site, and the ultrasound to assess repair success rate of the rotator cuff. The~     clinical and radiological outcomes will be compared between the study and control groups. It~     is hypothesized that there will be 85% high quality ossification at anchor site for HEALICOIL~     REGENESORB and 49.9% high quality ossification for TWINFIX Ultra HA at 24 months.~   "
92940|NCT02350634|"~     The study is designed to examine the relationship between imaging results detected on a~     18F-AV-1451 PET scan and pathology found at autopsy within six months of imaging.~   "
92941|NCT02350621|"~     A prospective randomized clinical trial. Cervical spondylotic foraminal stenosis with~     radiculopahty. Comparison results between 2 treatment options: ACDF and minimal invasive~     posterior cervical foraminiotomy.~      80 patients to be followed for 2 years. Parameters to study: NDI, VAS, EQ-5D, complications,~     health economics, recurrens of stenosis, movement of facet joints pre- and postoperatively~     (foraminotomy group).~   "
92942|NCT02350608|"~     Observational study of 20 postoperative cardiac surgery patients. On admission to the ICU the~     patients will receive a noninvasive monitor recording arterial pulse waveform and ECG. The~     monitoring will continue to the ward for two days. The data will be compared with the routine~     monitoring methods.~   "
92943|NCT02350595|"~     The potential health effects of high intake of lean or fatty fish will be investigated in~     overweight or obese adults. Participants consume 750g/week of fillets of fish for 8 weeks.~      Hypothesis:~      High intake of fatty or lean fish will beneficially affect glucose regulation and the immune~     system.~   "
92944|NCT02350582|"~     Patients with breast cancer undergo a series of psiclofisicas alterations during cancer~     treatment, chemotherapy phase being one of the more aggressive ete effect. These changes~     reduce the quality of life and result in a loss of physical health-related condition. Studies~     have shown that the practice of physical exercise and rehabilitation strategies enhance or~     attenuate the impact of chemotherapy on quality of life of patients. At present,~     technological development from telerehabilitación systems is a promising strategy that~     enables fast and efficient communication between health professionals and patients,~     especially at this stage of the disease where the patient may encounter difficulties in~     matching measures improving their lifestyle with aggressive medical treatment.~      To carry out this study a controlled study masked, parallel-group done were conducted usual~     care control group and an intervention based on a web system telerehabilitación to improve~     the physical condition associated with health and performed quality of life.~   "
92945|NCT02350569|"~     The primary objective of this study is to evaluate the antiviral efficacy of treatment with~     ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) therapy at the time of liver~     transplantation and through 4 weeks posttransplant in adults with genotype 1 or 4 hepatitis C~     virus (HCV) infection who are undergoing primary liver transplantation.~   "
92946|NCT02350556|"~     For several years, the postural disorders assessment in hemiplegic patients was conducted~     through force plate, using the center of plantar pressure displacement in a static position.~      These are widely used in physical therapy both for assessment and rehabilitation of patients~     with balance disorders.~      For hemiplegic patients, an asymmetric distribution support on each foot and an increased~     surface area of postural sways (more marked on the medio lateral axis) are observed.~      These studies, based on the study of plantar pressure ,are not enough to providea full~     description of the spatio-temporal organization of postural components in hemiplegic~     patients.~      Indeed, postural stabilometric evaluation is based on a simplification of the human skeleton~     by considering it as a simple inverted pendulum swinging on his ankles.~      This simplified model can't be used in dynamic assessment because of the simultaneous~     contributions of several joints during movement. This restricts its clinical interest because~     patients are more exposed to imbalances and falls in dynamic situations. Thus, the hip~     angular movement results in a center plantar pressure displacementwhich is impossible to~     discriminate from the ankle axis movement using stabilometric signal only.~      Thus, it seemed interesting to study another variable valid in dynamic conditions : the~     displacement of center of mass during a dynamic balancing task. This variable is obtained~     through 3D motion capture of the different segments of the human body. The dynamic test is a~     dynamic postural assessment following ball avoidance from three different directions. The~     center of mass displacement will be compared with a functional test known to be~     representative of dynamic balance of the individual capacities: The Timed Up and Go test~     (TUG).~      All of this data aims to improve the hemiplegic postural assessment for physical therapy and~     to help develop new rehabilitative approaches.~   "
92947|NCT02350543|"~     This study evaluates the continuation (non-discontinuation) of Aspirin during TURBT. Half of~     participants will continue their usual low-dose Aspirin regimen during TURBT and throughout~     the perioperative period, while the other half will discontinue Aspirin use ten days prior to~     surgery (standard recommendation) and restart therapy two weeks post-discharge.~   "
92948|NCT02350530|"~     BACKGROUND:~      For patients with liver-limited metastatic colorectal cancer (mCRC), complete resection of~     liver metastases is the only potentially curative treatment. The current goal of medical~     treatment for colorectal cancer with initially unresectable liver metastases is to maximize~     the rate of secondary resection and prolong overall survival (OS). A strong correlation was~     found between response rate and secondary resection rate of metastases, and the triple drugs~     combination of infusional 5-fluorouracil/leucovorin (5-FU/LV), irinotecan, and oxaliplatin~     (FOLFOXIRI) was recommended can be used in selected patients with potentially resectable~     metastases in order to improve response rate and make resection more possible. The addition~     of a anti-VEGFs monoclonal antibody such as bevacizumab to chemotherapy has been shown to~     increase response rate, resection rate and improve OS in the first-line treatment of mCRC~     patients. The efficacy and safety of bevacizumab in addition to triplet drugs were previously~     tested in OLIVIA trial, the resection rate of liver metastases of 49% was reported, and the~     response rate was 81%; most common grade 3-4 adverse events was neutropenia. On the basis of~     such promising results, we conducted the present randomized study to explore whether~     FOLFOXIRI plus bevacizumab compared with FOLFOXIRI alone as first-line treatment could~     improve radical resectability in patients with RAS mutation-type, unresectable liver-only~     metastatic colorectal cancer.~      OBJECTIVE:~      The primary objective of the FOBULM study is to evaluate the efficacy of FOLFOXIRI plus~     bevacizumab compared to FOLFOXIRI alone in patients with initially unresectable liver-limited~     RAS mutation-type mCRC.~      Secondary objectives are safety and tolerability of the treatment, efficacy in terms of~     objective response rate (ORR), OS, progression free survival (PFS), quality of life and an~     assessment of biomarkers for predictive response and prognosis.~   "
92949|NCT02350517|"~     This phase Ⅱ study was designed to evaluate the efficacy and safety of endostar combined with~     paclitaxel and nedaplatin as first-line therapy in treating patients with recurrent or~     metastatic esophageal squamous cell cancer.~   "
92950|NCT02350504|"~     MRI has been recognized for many years as the safest and the most precise imaging method,~     particularly for children. However, the accuracy of MRI demands from the patient to avoid any~     movement while the examination is in process. This task is accomplished with difficulty by~     children and requires the assistance of an anesthetizing staff. In this research, our main~     goal is to investigate an introductory instruction as an assistive tool in performing MRI~     without the need in anesthesia.~   "
92951|NCT02350491|"~     Rheumatoid arthritis (RA) is a systemic disease, which mainly targets joints and results in~     osteoarticular destruction and serious disability. When clinical symptoms (painful and~     swollen joints) occur, the innate and adaptive immune responses against self antigens have~     already been largely amplified. This might explain that even when RA patients are treated~     very early and aggressively, a remission of the disease can only be obtained in approximately~     half of them. This proportion of remission under treatment can only be achieved using treat~     to target strategies involving biologics, such as anti-TNF. Unfortunately, less than 20% of~     patients remain in remission after treatment discontinuation. Thus, despite the availability~     of 5 different types of biologics, there are still therapeutic unmet needs. However, a~     spontaneous, drug-free decrease of disease activity can be observed in a physiological~     condition, pregnancy. Although most of treatments of RA have to be discontinued during~     pregnancy, a marked improvement, and sometimes remission, can be observed during pregnancy,~     with frequent post-partum flares. The situation is the opposite with an increased risk of~     flares in systemic lupus erythematosus (SLE), a rare systemic autoimmune disease which~     generally progresses in flares-up and can affect nearly any organ (the skin, joints, kidneys,~     the brain, the heart, …). The course of the disease remains unpredictable for a given~     patient, and very few biomarkers are available to help clinicians to identify patients a risk~     of flares. Thus, safe therapeutic options remain limited, especially in patients with serious~     complications. A specific concern in SLE is the fact that the disease usually starts in women~     entering their sexual and reproductive life. Even with a stable condition (i.e : lupus~     without recent flares and no impaired renal or cardiac function) as it is medically~     recommended before getting pregnant, up to 40% of SLE patients flare up during pregnancy.~      We hypothesize disease-specific and pregnancy-induced epigenetic changes, especially those~     regarding the pattern and levels of microRNAs, could explain the clinical improvement and the~     risk of flares in RA and SLE, respectively. A better understanding of the underlying~     mechanisms could help to identify new biomarkers, notably those predicting flares in SLE, and~     therapeutic targets, by trying to mimicking or amplifying micro-RNA changes observed in RA~     and targeting them in SLE.~   "
92952|NCT02350478|"~     This study is planned to evaluate if linagliptin can improve endothelial function in patients~     with type 2 diabetes mellitus. In addition, the effect of linagliptin on arginine~     bioavailability ratios and postchallenge glycaemic control will be studied.~   "
92953|NCT02350465|"~     The objectives of this study are to: 1) validate a rapid, portable, cost-effective method for~     screening myosteatosis and sarcopenia using diagnostic ultrasound, and 2) investigate a novel~     approach to progressive resistance exercise involving eccentric muscle actions that will~     counter the local effects of myosteatosis and sarcopenia in African Americans.~   "
92954|NCT02350452|"~     Endometriosis is a benign chronic gynaecological disease that affects 10% of women of~     reproductive age and takes 40% of them to assisted reproduction techniques.~      The purpose of the study is to compare the antimüllerian marker (AMH) and antral follicular~     count (AFC) , with the most common serological markers of ovarian reserve. The investigators~     intend to confirm their clinical utility in the assessment of ovarian function, and to~     promote their use in predicting decreased ovarian reserve.~      The work therefore moreover arises the objective to validate the bibliographic data about~     using the laser for haemostasis after stripping endometriomas, to amplify knowledge available~     in the literature on the surgical treatment of ovarian endometriomas and on the diode laser~     application in minimally invasive surgery, appraising the trend of AFC and AMH levels and the~     possible surgical implications on fertility .~   "
92955|NCT02350439|"~     Fractional flow reserve (FFR) is an established invasive method for assessing the~     physiological significance of coronary artery stenosis. However, in recent studies it has~     been observed and reported some degree of variation in the fraction of the coronary artery to~     the aortic pressure (Pd / Pa) during the infusion of standard adenosine dose (140mg/kg/min).~     The observed variation may be attributed to a failure to achieve maximal hyperemia with the~     normal dose. The administration of adenosine at a higher dose (200μg/kg /min) may influence~     coronary flow reserve (FFR) eliminating Pd / Pa variation during adenosine infusion.~      This is a prospective study which will be conducted in patients after coronary angiography~     with at least one angiographic lesion ≥50% in coronary vessels.~      Patients after written consent will undergo assessment of lesion severity with FFR under a~     three-minute infusion of adenosine 140mg/kg/min. In patients during steady state hyperaemia~     (determined by visual assessment) exhibiting variation in Pd / Pa ratio ≥ 0.05 (e.g.~     difference of max Pd/Pa minus min Pd/Pa) the examination will be repeated after 5 min with~     three-minute infusion under high dose adenosine (200mg/kg/min). The minimum ratio Pd/Pa per 3~     beats will be offline analyzed. The FFR during steady hyperemia state is defined as the~     average of the minimum ratio Pd / Pa per three beats.~   "
92968|NCT02350270|"~     The main objective of the GOOD initiative was to determine which spatio-temporal gait~     parameters and/or combination(s) of spatio-temporal gait parameters best differentiate~     between cognitively healthy individuals (CHI), patients with mild cognitive impairment (MCI)~     and those with mild and moderate dementia.~   "
93473|NCT02343640|"~     The purpose of this study is to use ultrasound imaging to determine if there are certain~     frequencies, durations, and intensities of baseball pitching that expose a college baseball~     player to increased risk of injury to their ulnar collateral ligament of their elbow~     throughout one baseball season.~   "
92956|NCT02350426|"~     This is an adaptive Positron Emission Tomography/ Computed Tomography (PET/CT) and Dynamic~     Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) open-label study design for the~     investigation of inflammation in adult rheumatoid arthritis (RA) patients, not involving~     therapeutic intervention. Each study participant will undergo two half body PET/CT scans from~     the pelvis to the bottom of the feet (including hands and wrists) with an additional bed~     position centred on the shoulders. One scan will be conducted with 18F-FDG and the other with~     18F-GE-180. The first PET/CT scan (PET1) will be performed 4 weeks (28 +/- 2 days) after the~     first screening visit, whereas the second PET/CT scan (PET2) will be carried out within 2~     weeks (7 +/- 7 days) after PET1. The order of PET/CT scans for each subject will be based on~     a computer generated randomisation schedule after the screening visit. A sub-group of study~     participants will be invited to undergo an additional dynamic 18F-GE-180 PET scan of a~     selected joint (knee or wrist) prior to their 18F-GE-180 PET/CT half body scan. The primary~     objective of the study is to quantify inflammation in joints of RA patients by determining~     18F-FDG and 18F-GE-180 uptake using PET, and DCE-MRI parameters.~   "
92957|NCT02350413|"~     The experience of the chronic illness negatively engraves on the quality of life of patients.~     Endometriosis is a disease that affects millions of women of childbearing age; it has~     repercussions on psychological health, as shown by numerous recent studies.~      The aim of the present study is to validate the italian version of EPH 30, a self reported~     questionnaire, already used internationally, in order to determine the quality of life in~     women with endometriosis, assess their psychological health and the effectiveness of~     therapies.~   "
92958|NCT02350400|"~     Background~      Hepatic metastases of colorectal cancer (MCC) is quite common and is a major source of~     morbidity and mortality. There has been evidence to show that hepatic arterial~     chemoembolisation using DC beads (drug eluting beads, 100-300μm) loaded with irinotecan~     (DEBIRI) showed improved overall survival when compared to systemic therapy (FOLFIRI), but~     being larger they have their limitations.~      New 70-150μm beads are recently available and currently there is limited data concerning its~     use. Safety of these beads have not been tested in local patients.~      Hypothesis / Aim To study the safety and pharmacokinetics of the smaller 70-150μm DEBIRI in a~     pilot study of 5 patients. The smaller 70-150μm beads will be able to deliver a more~     consistent and higher dose to tumoral tissue with a smaller systemic dose. Being smaller and~     less embolic, it will also be better tolerated. Patients will also be genotyped for their~     UGT1A1*28 and UGT1A1*6 polymorphism status as the latter genotypes are associated with~     decreased clearance of irinotecan and SN-38 in Asian patients.~      Methods Single centre, pilot study, prospectively recruiting 5 patients with unilobar~     disease, refractory to systemic chemotherapy~      The primary endpoints:~        1. establish safety and toxicity profile of the irinotecan loaded DEBIRI beads~        2. establish pharmacokinetics and systemic exposure of irinotecan and its active~          metabolite, SN-38.~      The secondary outcome measurements:~        1. the incidence and severity of adverse events, liver function parameters and laboratory~          abnormalities;~        2. response rate,~        3. progression free survival~        4. overall survival~      Clinical Significance~      This treatment modality has the advantage of directly delivering irinotecan to the liver~     metastases from colorectal cancer. This local mode of drug delivery may result in a higher~     intratumoral drug concentration and rapid tumour shrinkage leading to downstaging of the~     hepatic metastatic lesions. These therapeutic outcomes may also downstage patients to hepatic~     resection.~   "
92959|NCT02350387|"~     The purpose of this study is to determine if there are differences in balance, strength,~     functional performance and self-reported outcomes for subjects with knee osteoarthritis who~     complete a low intensity, long duration eccentric training program compared to those who~     complete a high intensity, short duration eccentric training program. This study will be~     utilizing the Eccentron (manufactured by BTE Technologies) for the performance of all~     eccentric exercise.~   "
92960|NCT02350374|"~     The total amount of carbohydrates (CHO) at meal consumed strongly predicts the glycemic~     response in children and adolescents with type 1 diabetes. Carbohydrate counting is a~     technique to adapt a dose of rapid acting insulin to the carbohydrate content of a meal.~     Thanks to this flexible insuline therapy, the glycemic control and the quality of life tend~     to improve. Carbohydrate counting is a recommended technique in the adult diabetic~     population. There is little data on the use of this methode in youth with diabetes. There are~     no studies on the change of carbohydrates content at meals in children and adolescents with~     diabetes practicing counting carbs, while it is the main interest of this technique. The aim~     of this study is to assess how children and adolescents with type 1 diabetes use the~     possibility to change their carbohydrate amount at each main meal when they use the counting~     carb method. The investigators hypothesize that children vary their amount of CHO greatly.~     This is an argument for using this technique in pediatrics~   "
92961|NCT02350361|"~     Here we are going to find a method by using available multiple drugs including angiogenesis~     medicine - Endostar to treat lung cancer patients who acquired resistence from EGFR-TKI but~     have responsed to it before.~   "
92962|NCT02350348|"~     To study the 30-day morbidity and mortality after neonatal anaesthesia, and predictive~     factors that can be responsible for poor outcome.~   "
92963|NCT02350335|"~     All patients with acute aneurysmal hemorrhage are treated in accordance with our~     institutional protocol. After securing of the aneurysm, some smokers with acute aneurysmal~     hemorrhage are randomly assigned to transdermal nicotine replacement (NRT). The short- and~     long-term effect of NRT will be studied comparing non-smokers, smokers without NRT and~     smokers with NRT.~   "
92964|NCT02350322|"~     The aim of this study is to assess the effects of giving a schoolmeal with fatty fish, a~     schoolmeal without fish or omega-3 capsules on Noregian adolescents cognitive performance~     (concentration and learning abilities), mental health statua and markers of nutritional~     status. In addition, to disentangle the effect of fatty fish eaten as food and the effects of~     omega-3 fatty acids taken as a supplement.~   "
92965|NCT02350309|"~     This is a single-dose, randomized, placebo-controlled, 3-way crossover study of 2 dosage~     strengths of E2006 (5 mg and 10 mg) in subjects with insomnia disorder.~   "
92966|NCT02350296|"~     The present bioequivalence phase I study is needed to compare the bioavailability and the~     concentration-time profile of the new immediate release formulation of KLS 40 mg with the~     reference compound OKi®, ketoprofen lysine salt 80 mg granules for oral solution (bipartite~     sachets).~      The objective of the study is to investigate the bioequivalence between two formulations~     containing ketoprofen lysine salt (KLS) when administered as single oral dose in two~     consecutive study periods to healthy male and female volunteers under fasting conditions.~   "
92967|NCT02350283|"~     To evaluate the safety and efficacy of Solitaire thrombectomy in Chinese patients with acute~     stroke within 12 hours of symptom onset.~   "
93031|NCT02349438|"~     This study will test the feasibility that differences in contact lens wettability can be~     measured with a wavefront sensor.~   "
92969|NCT02350257|"~     The primary objective of this study is to test the effectiveness of internet-delivered and~     therapist-guided internet-based cognitive behavior therapy (ICBT) for children with anxiety~     disorders (including social anxiety disorder, separation anxiety disorder, generalized~     anxiety disorder, panic disorder and specific phobia) in a randomized trial where~     participants will be allocated to either ICBT or to a supportive control condition.~     Non-responders (defined as those participants who still uphold their primary anxiety disorder~     after the ICBT treatment) will be offered traditional (face-to-face) CBT. Follow-ups are~     conducted at 3 and 12 months after treatment completion.~   "
92970|NCT02350244|"~     Evaluate the benefit of an intervention by a computer program comprising active breaks, in~     the form of a personalized self-program on functional impairment and / or pain, among~     employees with latent or symptomatic upper extremity MSDs and spine (+/- eyestrain) in~     connection with the computer work environment.~   "
92971|NCT02350231|"~     Multiple pregnancies accounted for 1 - 6 % of all births in UK during 2007. More than 98% of~     these multiple births being twin births . Preterm birth defined as birth occurring prior to~     37 weeks of gestation and it was about 15 % of pregnancies in developed world and 12.7 % in~     the United States.~      Preterm birth is the leading cause of infant and neonatal mortality. Premature neonates are~     at increased risk of developing respiratory distress syndrome, sepsis, intraventricular~     hemorrhage, and necrotizing enterocolitis.~      Twin pregnancy is considered one of the important risk factors of preterm birth. Over~     distension of uterus may be one of the etiological factors for preterm birth. However, no~     definite effective interventions have been shown to prevent preterm delivery in twin~     pregnancy.~      Three large randomized trials suggested that progesterone might prevent preterm delivery in~     high-risk singleton pregnancy especially those with previous preterm delivery or short cervix~     might be reduced by antenatal progesterone.~      Fonseca et al (2007) concluded that women with short cervix are less likely to deliver~     preterm ≤34 weeks if they are treated with vaginal progesterone.~   "
92972|NCT02350218|"~     The purpose of this study is to evaluate superiority of Eglandin® (Alprostadil) 720㎍compared~     to 360㎍ in terms of safety, efficacy in living donor liver transplant patient, peak AST~     levels followed by Eglandin administration were assessed.~   "
92973|NCT02350205|"~     This clinical trial is designed to assess the safety, effectiveness and benefits of Self~     Assembled Skin Substitute SASS grafts as a permanent skin replacement for the treatment of~     full-thickness burn wounds that require permanent coverage where the availability of donor~     sites is limited.~   "
92974|NCT02350192|"~     Cardiovascular disease (CVD) is the leading cause of death globally and e-health educational~     programs have been proved to be effective support to CVD clients. However, most e-health~     programs lack personalization and this seldom results in exercise behavioral change.~     Considering the advantages of e-health programs, as well as the widespread internet use and~     the rising trend of younger patients having CVD in Hong Kong, we conducted a Randomized~     Controlled Trial (RCT) to investigate the effectiveness of a home-based interactive e-health~     educational intervention versus usual care for middle aged cardiac vascular (CV) patients on~     their total physical exercise, exercise adherence and quality of life.~   "
92975|NCT02350179|"~     The aim of this study is to evaluate the efficacy of tranexamic acid in reducing blood loss~     during and after elective C.S.~      The Research Question Is Tranexamic acid effective in reducing blood loss during and after~     elective Caesarean section?~      The Research Hypothesis The TXA could be able to reduce blood loss during and after elective~     Caesarean section.~      The null hypothesis will therefore state that:~      There will be no difference between TXA and placebo in reducing blood loss during and after~     elective Caesarean section.~   "
92976|NCT02350166|"~     Surgical resection is still recommended as the optional treatment for colorectal liver~     metastasis (CLM) patients. There are two main concerns for resectable colorectal liver~     metastasis which remain controversial: surgical time and surgical type. As for the former,~     synchronous resection of primary colorectal tumor and liver metastasis, with the reason of~     fare overall survival rate and absence of a second surgery, has gained wide population from~     gastrointestinal surgeons who believe it will bring benefits to CLM patients. With regard to~     surgical type, Open liver resection is the optimum choice for CLM patients no matter what the~     metastasis profile is. And for management of primary tumor, laparoscopic procedure is mature~     in surgical skill and has been evidenced equivalent overall survival rate compared with open~     resection. So, primary colorectal tumor resection could be either open or laparoscopic~     procedure. Therefore, the investigators team conducted the controlled trial to compare two~     surgical procedures in treatment of resectable colorectal liver metastasis. Patients will be~     randomly assigned into conventional laparotomy group for simultaneously resection of both~     primary colorectal tumor and liver metastasis, or laparoscopic-assisted small-incision group~     for resection of laparoscopic colorectal tumor combined with synchronously small-incision~     open resection of liver metastasis. The aim of this trial is to observing short-term~     operative effects after surgeries.~   "
92977|NCT02350153|"~     The purpose of this study is to study since 1987 all patients diagnosed with CD in Sweden and~     determine their outcomes including mortality. A secondary objective is to focus on patients~     in remission and identify determinants of their different outcomes.~   "
92978|NCT02350140|"~     Early accurate diagnosis is one of the first crucial steps in care for infants born to~     HIV-infected mothers. Early initiation of antiretroviral therapy (ART) relies upon early~     diagnosis and results in significant reductions in infant morbidity and mortality. The~     investigators recently concluded a successful randomized controlled trial in Kenya entitled,~     Improving uptake of early infant diagnosis of HIV for prevention of mother-to-child HIV~     transmission (PMTCT): a randomized trial of a text messaging intervention~     (ClinicalTrials.gov # NCT01433185). In this study, text messages developed using a behavioral~     theoretical framework significantly improved maternal attendance at post-partum clinic~     appointments and rates of testing to facilitate early infant diagnosis of HIV in a selected~     population and controlled setting. Understanding the effectiveness of this intervention (and~     its limitations) in a real-world, routine-care setting represents the next step in the~     translational pathway to public health impact. The investigators therefore now propose a~     cluster randomized, stepped wedge trial in 20 clinics operated by the Kenyan Ministry of~     Health in the Nyanza region of Kenya and use the Reach, Effectiveness, Adoption,~     Implementation, and Maintenance (REAIM) framework to understand the effectiveness of the text~     messaging to improve testing (TextIT) intervention. Our specific aims are:~        1. To determine the effect of TextIT on maternal attendance at postpartum clinic visits~          during the randomized stepped-wedge rollout of the intervention.~           Hypothesis 1: A greater proportion of women at health facilities implementing TextIT~          will attend clinic within eight weeks postpartum compared to women at health facilities~          implementing standard care.~        2. To determine the effect of TextIT on virological infant HIV testing within eight weeks~          after birth during the randomized stepped-wedge rollout of the intervention.~           Hypothesis 2: Infants of women at health facilities implementing TextIT will be more~          likely to have virological HIV testing compared to infants of women at health facilities~          implementing standard care.~        3. To determine the costs and cost-effectiveness of TextIT. The investigators will estimate~          the cost per patient and per health gain achieved (disability-adjusted life year, DALY)~          comparing TextIT to current standard care.~      Hypothesis 3: The TextIT intervention will be more cost-effective than current standard care.~   "
92979|NCT02350127|"~     Nearly 1 in 10 older Veterans have dementia, which is a devastating condition that leads to a~     progressive loss of independence and functional status. Currently available dementia~     medications do not alter the disease course. Therefore, it is critically important to~     identify effective strategies for helping older Veterans living with dementia to enhance~     their functional status and quality of life. The investigators have developed a novel,~     integrative exercise program called Preventing Loss of Independence through Exercise (PLIE)~     that incorporates elements from Eastern and Western exercise modalities and is designed to~     build and maintain the capacity to perform basic functional movements while increasing~     mindful body awareness and enhancing social connection. Pilot study results suggest that PLIE~     is associated with meaningful improvements in physical function, cognitive function and~     quality of life as well as reduced caregiver burden. The goal of the current study is to~     perform a full-scale randomized, controlled trial to test the efficacy of PLIE in older~     Veterans with dementia.~   "
92980|NCT02350114|"~     This is an observational study of the functional capacity of patients with Heart failure with~     Reduced Ejection Fraction (HFrEF) who are admitted to the hospital for routine medical~     treatment.~   "
92981|NCT02350101|"~     In 2008 at the University Hospital Zurich (USZ) a massive transfusion protocol was~     introduced. Based on laboratory diagnostics and point of care (POC) devices including ROTEM.~      Goal of this retrospective study is to evaluate the influence of this algorithm on~     coagulation, use of blood products, coagulation factors and ROTEM evolution.~   "
92982|NCT02350088|"~     To evaluate the safety and efficacy of Hirschsprung's disease~   "
92983|NCT02350075|"~     The aim of this study is to determine the clinical success of short implants (6mm) alone and~     standard implants (10mm) combined with sinus floor elevation in atrophic maxilla.~   "
92984|NCT02350062|"~     Different neuromuscular monitors may be available in the same care structure. Two different~     monitors are available in the investigators' institution in the operative room and the~     recovery room. However, these two monitors have not been compared and may not be~     interchangeable. Starting the monitoring with one device and continuing with another device~     may be inaccurate and may lead to inadequate medical decisions. The investigators therefore~     conducted this observational study to compare the two devices available in our institution.~   "
92985|NCT02350049|"~     The purpose of this study is to evaluate the safety and effectiveness of the Cementless~     Oxford Partial Knee System.~   "
92986|NCT02350036|"~     50 pregnant females were divided in two groups, twenty five as a control group and twenty~     five as high risk group; they were subjected to uterine artery Doppler, measurement of~     maternal serum and detection of (MTHFR) gene polymorphisms in first trimester at 11 to 14~     weeks of gestation, all pregnancies were followed until 40 weeks for development of~     pre-eclampsia~   "
92987|NCT02350023|"~     Alopecia areata (AA) is an autoimmune disease that involves the hair follicles. Topical~     corticosteroids are the established agents for treating this disorder. There are several case~     reports and case series which have demonstrated the efficacy of topical prostaglandins. The~     two agents have not been compared head-to-head in the published literature. The investigators~     attempt to compare the efficacy and safety of topical betamethasone and topical latanoprost~     in the treatment of localised alopecia areata.~   "
92988|NCT02350010|"~     There were lack of data and analysis about medical management, etiology, and long-term~     outcome of Intracerebral Hemorrhage (ICH) in Beijing. In this study the investigators do~     acute CT angiography, a non-invasive imaging method to explore etiology and prognostic risk~     factors of ICH. Further the investigators will aim to develop and validate a risk score for~     predicting 1-year functional outcome after ICH.~   "
92989|NCT02349997|"~     Fluid retention in the legs due to chronic heart failure (CHF) during the daytime may~     redistribute to neck when with supine positioning at night. A portion of the shifted fluid~     accumulates in the neck, and narrows the upper airway, predisposing the patient to~     obstructive sleep apnea (OSA) and central sleep apnea (CSA). However, the mechanism of~     overnight fluid shift on OSA and CSA remains unclear. The investigators pre-experiment~     demonstrated there may be a different mechanism of overnight fluid shift on OSA and CSA. The~     accumulation of water content in neck soft tissue increases neck circumference and leads to~     pharyngeal resistance, upper airway collapse and causes OSA. The effect of nocturnal fluid~     shift on CSA may be because of increasing of chemosensitivity (fluctuation of PaCO2),~     circulation delay and hemodynamic disordered. This study is aimed to explore the different~     mechanism of overnight fluid shift on OSA and CSA by comparing the changes of upper airway~     (inside diameter, water content, and pharyngeal resistance), PaCO2, circulation delay~     (lung-to-finger circulation time) and hemodynamic (loop gain).~   "
92990|NCT02349971|"~     This study looks to examine the feasibility and efficacy of using MR-HIFU to ablate Osteoid~     Osteoma lesions in children and young adults.~   "
92991|NCT02349958|"~     To determine treatment response to surgical debulking and intra-operative Intraperitoneal~     Hyperthermic Chemotherapy (IPHC) in patients with the following malignancies:~      Gynecologic cancers (ovarian, primary peritoneal or fallopian tube, and uterine/cervical~     cancers).~      Mesotheliomas. GI cancers (Gallbladder, liver, small intestine, pancreas, stomach, colon,~     appendix).~      To monitor the toxicities and complications of this treatment regimen. To measure treatment~     related QOL changes after IPHC.~   "
92992|NCT02349945|"~     CONDITION: Idiopathic male infertility In men with idiopathic infertility, the sperm DNA~     fragmentation index (DFI) within 12 weeks of FSH therapy and 12 weeks follow-up improves~     depending on the FSHR genotype as assessed by the non-synonymous SNP rs6166 (wild type or~     p.N680S).~      This is a phase II b, multicenter, prospective, open label, one arm, clinical trial~     stratified according to the patient's genotype.~      INTERVENTION: FSH therapy (150 I.U. sc every other day for 12 weeks) in infertile men who are~     homozygous for the wild-type FSHR or the p.N680S allele of the FSHR. Duration of intervention~     per patient: 12 weeks~      Primary efficacy endpoint: Sperm DFI. Number of patients with an improvement in DFI > 60% Key~     secondary endpoint(s): pregnancy, semen parameters, serum levels of inhibin B and AMH.~   "
93032|NCT02349425|"~     A randomized, double-blind, placebo-controlled, crossover, dose escalation study of~     gefapixant (AF-219) in subjects with Refractory Chronic Cough.~   "
93474|NCT02343627|"~     This study will examine the safety, tolerability and efficacy of NVXT in a new formulation in~     patients with mild-to-moderate fungal infection of the toe nail.~   "
92993|NCT02349932|"~     A person's blood type is defined by the types of sugars they express on their red blood~     cells, with antibodies being made to non-self sugars and excluding blood cells expressing~     these sugars (the basis of blood transfusion reactions). These same sugars can be expressed~     by commensal bacteria in our gut lumens. The investigators hypothesize that a person's~     antibodies to non-self sugars also attach to and exclude non-self sugar-expressing bacteria~     in our guts. Supporting our hypothesis, a person's blood type correlates with the overall~     composition of their gut flora. Because these sugars are also used by certain pathogens to~     initiate infection, this information could directly inform our understanding of host~     susceptibility to various infectious organisms.~   "
92994|NCT02349919|"~     The purpose of this study is to investigate the effectiveness of oral procaterol in treatment~     of non-asthmatic patients who suffer from persistent cough following upper respiratory tract~     infection (URTI).~   "
92995|NCT02349906|"~     The aim of the trial is to describe the safety and efficacy of intravenous (i.v.) Treosulfan~     compared to the conventional (myeloablative) dose of i.v. Busulfan, each administered as part~     of a standardised Fludarabine-containing conditioning regimen and to contribute to a PK model~     which permits - in conjunction with data comparing Treosulfan and Busulfan in adults with~     malignant diseases - to extend the use of Treosulfan in the paediatric population by~     extrapolating efficacy.~   "
92996|NCT02349893|"~     The United States is currently experiencing an increase in the incidence and prevalence of~     obstructive sleep apnea (OSA). With prevalence in middle-aged adults of 2 to 4% of the~     population, untreated OSA has been implicated in increased risk for cardiovascular disease,~     including hypertension and heart failure, daytime sleepiness, and increased risk of motor~     vehicle accidents.~      This study was design in order to evaluate the CelonProSleep plus for multi-level~     radiofrequency ablation (RFA) of the palate and base of tongue as a treatment for mild to~     moderate obstructive sleep apnea syndrome (OSAS).~   "
92997|NCT02349880|"~     Shared decision-making is being promoted as a promising approach for engaging patients with~     schizophrenia in medical decisions and improving satisfaction and adherence.~      To implement shared decision-making, both physicians and patients should commit to it and~     engage in a mutual decision process. Most research, however, has addressed interventions that~     either focus on the doctors' side (e.g. communication skills) or on informing patients~     about treatment options (e.g. decision aids). These approaches have been shown to be~     feasible in clinical practice but had no strong effects on treatment patterns or adherence,~     possibly because they were insufficient to motivate and enable patients to engage actively in~     decision-making. Moreover, these interventions still rely on the doctor's willingness to~     share decisions, which has been shown to vary considerably.~      To overcome these limitations and since many patients do not feel competent to participate in~     decision-making we developed an intervention that focuses on patients' communicative~     competencies. this intervention, a five session group-training, will be implemented for~     inpatients suffering from schizophrenia.~   "
92998|NCT02349867|"~     This is a phase 1 study of concurrent chemoradiation using a regimen of sorafenib and~     vorinostat with gemcitabine and radiation following chemotherapy in patients with pancreatic~     cancer to find the RP2D of the concurrent chemoradiation combination. A traditional 3+3~     dose-escalation design will be conducted for the sorafenib and vorinostat dose escalation.~     Adenocarcinoma of the pancreas without distant metastasis that has been treated with ≥ 1~     prior therapy (not including radiation) encompassing at least 2 months. Adequate hematologic,~     hepatic, and renal function. Ability to take oral medication. To determine the doses and~     schedule appropriate for phase 2 study of sorafenib and vorinostat with concurrent~     gemcitabine and radiation therapy (RT) as neoadjuvant treatment of pancreatic cancer~     following chemotherapy.~   "
92999|NCT02349854|"~     Seborrheic dermatitis is a common, inflammatory skin condition that causes flaky, white to~     yellowish scales to form on oily areas such as the scalp or inside the ear. These scales can~     occur with or without underlying reddened skin. In addition to causing psychological~     distress, low self esteem, and embarrassment, seborrheic dermatitis is associated with scalp~     pruritus (itch). Treatment modalities exist to control scalp flaking and itch associated with~     seborrheic dermatitis, although such therapies often lose efficacy over time. As seborrheic~     dermatitis is a chronic (life-long) condition, better treatments are needed. The~     investigators propose to better characterize in subjects with seborrheic dermatitis involving~     the scalp versus normal scalp controls: (a) the clinical characteristics of the associated~     itch and (b) the pattern of nerve innervation to the scalp. In this way, the investigators~     hope to get a comprehensive understanding of the factors causing scalp itch with the aim that~     this information will create new candidates to which treatment modalities can be designed. At~     least 12 (up to 20) subjects and similar number of control subjects without disease will have~     one clinic visit including questionnaires, testing of sensation on the scalp, and biopsy of~     the scalp.~   "
93000|NCT02349841|"~     To evaluate the early bactericidal activity (EBA), safety, tolerability and pharmacokinetics~     of meropenem administered intravenously three times a day, plus amoxycillin/CA administered~     orally three times a day; and of faropenem administered orally three times a day, plus~     amoxycillin/CA administered orally three times a day; for 14 consecutive days, in adult~     participants with newly diagnosed, smear positive pulmonary tuberculosis, in order to help~     establish proof-of-concept for carbapenem antibiotics as antituberculosis agents and to~     select the appropriate agent and route of administration for later stage clinical~     development.~   "
93001|NCT02349828|"~     A prospective, randomized trial to calculate incidence of Herpes Simplex Virus in an~     in-patient burn population and determine efficacy of prophylactic antiviral therapy to~     prevent viral infection and/or reactivation. Hypothesis is that antiviral prophylaxis will be~     effective in reducing HSV infection/reactivation.~   "
93002|NCT02349815|"~     -  To describe characteristics (demographic, clinical, social) of first time users of~          Jaydess~        -  To estimate the duration of use of Jaydess~        -  To study switching patterns, e.g. what are the hormonal contraceptive methods used~          before and what are the methods after discontinuing Jaydess~        -  To study off-label use of Jaydess~   "
93003|NCT02349802|"~     Phase I study to determine the device-related injection failure rate of the single-use,~     pre-filled autoinjector.~   "
93094|NCT02348619|"~     This trial is a 6-week, double-blind, placebo-controlled, randomized-withdrawal, multicenter~     study of safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult~     subjects with OSA.~   "
93004|NCT02349789|"~     Gait and balance disturbances are one of the most incapacitating symptoms of Parkinson's~     disease (PD) (Boonstra et al. 2008). They can cause falls and are therefore associated with~     the negative spiral of (near) falls, fear of falling, fractures, reduced mobility and social~     isolation; hence, having a profound negative impact on quality of life (Lin et al. 2012).~     Originally, symptoms of PD were ascribed to dopamine deficiency and basal ganglia dysfunction~     (Wu et al. 2013). However, in the last decades it has become clear that other brain~     structures are also involved in the pathophysiology of PD (Snijders et al. 2011; Stefani et~     al. 2007). An intriguing, emerging insight is that the cerebellum may be involved in the~     pathophysiology of PD (Wu et al. 2013). That is, the cerebellum is hyperactive in PD patients~     during different motor tasks (Yu et al. 2007; Hanakawa et al. 1999; del Olmo et al. 2006).~     However, whether cerebellar hyperactivity is pathological or compensatory and how it affects~     gait and balance in PD patients remain open questions. Here, the investigators aim to~     elucidate the role of the hyperactive cerebellum in gait dysfunction in PD patients by~     modulating cerebellar excitability with state-of-the-art non-invasive brain stimulation~     techniques and investigate the effects on gait.~   "
93005|NCT02349776|"~     Allograft transplants are offered to people with haematological cancers sometimes as the best~     chance of a cure. However, the survival rates for these procedures can be quite poor, as the~     transplant, in itself, can be lifethreatening.~      In addition, these procedures usually involve a period of lengthy hospitalisation accompanied~     by a host of debilitating conditions which patients must cope with in isolation due to their~     increased risk of serious infection. Perhaps unsurprisingly, there is considerable evidence~     that mood plays a role in the way people recover.~      I wish to investigate the psychological impact of providing testimonies from survivors of~     transplants to patients undergoing the procedure.~      The plan is initially to collect about 10-15 testimonials from past transplant patients using~     a videotaped structured interview then to collate these testimonials into a booklet format~     and DVD.~      This booklet and DVD would be used as an intervention where 40 consecutive patients who are~     going ahead for transplant are invited to receive the testimonial intervention.~      Patients will be asked to complete one mood measure (the HADS), the Life Orientation Test~     (LOT), and a questionnaire about expectations of treatment in clinic once a decision to~     proceed to transplant has been made. Patients will receive the testimonies upon admittance to~     the transplant unit and then receive the HADS and a structured interview within the first~     week of being admitted to the transplant ward (just prior to receiving the transplant) and~     within the first two weeks following the transplant.~      Comparative analyses of the measures between the three time points would be performed and~     qualitative analysis of the structured interview data.~      Around 80 people undergo transplant each year, it is estimated that the project will be~     completed by September 2016. The intention would be to publish following completion.~   "
93006|NCT02349763|"~     Comparison of the efficacy and side effects of intravenous and oral regimens of dexamethasone~     for prophylaxis of paclitaxel-associated hypersensitivity reactions in primary ovarian,~     fallopian tube and peritoneal cancer patients receiving first cycle of combination paclitaxel~     and carboplatin.~   "
93007|NCT02349750|"~     The study included 154 infertile women Patients received 100 mg of oral clomiphene citrate~     for five days starting on day 3 of the menstrual cycle, followed by daily injection of 150 IU~     of hMG and when more than two dominant follicles reached a diameter of 17 mm 5,000 IU of hCG~     was injected intramuscularly. Patients were randomly allocated into two equal groups: Group C~     received IUI without ESI and Group S had ESI using No.8 neonatal feeding tube and after 24 to~     36 hours, IUI was performed. Successful pregnancy was con-firmed by ultrasound and patients~     had failed trial underwent another trial of IUI for a maximum of three trials.~   "
93008|NCT02349737|"~     Evaluation of electromagnetic interference between Bioelectrical Impedance Analysis (BIA) and~     implantable cardioverter defibrillators (ICDs).~   "
93009|NCT02349724|"~     The main purpose of this research is to verify the safety of CEA targeted chimeric antigen~     receptor T cells and to determine the proper dosage of CAR T cells infused.~   "
93010|NCT02349711|"~     In this randomized, double-blind, placebo-controlled study, participants with seasonal~     allergies will receive a daily probiotic or placebo for 8 weeks. Questionnaires will assess~     health-related quality of life, stress, physical activity, gastrointestinal symptoms, adverse~     events, and compliance. In a subset of subjects, stool and blood samples will be collected at~     baseline and at week 6 of the intervention (estimated to be peak allergy season) to~     characterize microbial communities and immune function.~   "
93011|NCT02349698|"~     The main purpose of this research is to verify the safety of CD19 targeted chimeric antigen~     receptor T cells and to determine the proper dosage of CAR T cells infused.~   "
93012|NCT02349685|"~     As increasing the antibiotics resistance, the effectiveness of traditional Helicobacter~     pylori (H. pylori) therapies has been declined coincidently. In this study, the investigators~     evaluated the efficacy of H. pylori eradication between a personalized therapy for H. pylori~     infection based on the results of antibiotics resistance by using H. pylori culture and~     minimal inhibitory concentration (MIC) and the traditional 2nd rescue regimens, and the~     investigators analyzed the prevalence of the antibiotic resistance after 1st eradication of~     H. pylori in the tailored therapy group.~   "
93013|NCT02349672|"~     Hypoxic-ischemic encephalopathy (HIE) is a serious birth complication due to systemic~     asphyxia which occurs in about 20 of 1,000 full-term infants and nearly 60% of premature~     newborns. Between 10-60% of babies who exhibit HIE die during the newborn period and up to~     25% of the HIE survivors have permanent neurodevelopmental handicaps in the form of cerebral~     palsy, mental retardation, learning disabilities, or epilepsy. HIE also has a significant~     financial impact on the health care system. In the state of Florida, the total cost for~     initial hospitalization is $161,000 per HIE patient admitted, but those costs don't take into~     account the life-long costs.~      Current monitoring and evaluation of HIE, outcome prediction, and efficacy of hypothermia~     treatment rely on a combination of a neurological exam, ultrasound, magnetic resonance~     imaging (MRI) and electroencephalography (EEG). However, these methods do a poor job in~     identifying non-responders to hypothermia. MRI requires transport of the neonate with a~     requisite 40-45 min scan, which is not appropriate for unstable neonates. Moreover, the~     amplitude integrated EEG (aEEG), a common bedside monitoring technique currently used in~     these patients to assess candidates and predict outcomes prior to hypothermia, can be~     adversely affected by hypothermia itself and the patient may not appear to improve until~     re-warming. Consequently, the development of a simple, inexpensive, non-invasive, rapid~     biochemical test is essential to identify candidates for therapeutic hypothermia, to~     distinguish responders from non-responders and to assess outcome. This research is the first~     step needed to treat neonates with HIE employing a personalized medical approach using serum~     proteins GFAP and UCH-L1 as biomarkers and by monitoring neonates responses to therapeutic~     hypothermia. These biomarkers will aid in the direct care by providing a rapid test to~     predict outcomes and select candidates who are likely to benefit from therapeutic hypothermia~     and gauge a response to the neuroprotective intervention.~   "
93014|NCT02349659|"~     24-SMI-2014 is a Randomised Controlled Trial with an optional one way cross-over comparing~     Conservative Medical Management (CMM) to treatment with the Axium neurostimulator + CMM.~     Subject population is chronic inguinal pain refractory to previous surgical intervention~     (neurectomy).~   "
93015|NCT02349646|"~     10-SMI-2012 is a post market observational, questionnaire based study to assess the~     effectiveness of the commercially available Axium neurostimulator in the management of~     peripheral neuropathy~   "
93016|NCT02349633|"~     This is a Phase 1/2 study of PF-06747775 as a single agent and in combination with other~     cancer treatments in patients with advanced EGFRm NSCLC. The overall clinical study consists~     of a Phase 1 single agent dose-escalation and expansion part to determine the RP2D of~     PF-06747775 single agent in patients with previously-treated EGFRm NSCLC followed by~     sequential evaluations of PF-06747775 at the RP2D in 3 different clinical scenarios as~     detailed below:~        -  Cohort 1: Phase 2 evaluation of PF-06747775 as a single agent in previously untreated~          patients with advanced EGFRm NSCLC,~        -  Cohort 2: Phase 1b single arm evaluation of PF-06747775 in combination with palbociclib~          (Cohort 2A) followed by Phase 2 randomized evaluation of PF 06747775 in combination with~          palbociclib vs PF-06747775 single agent (Cohort 2B) in previously-treated patients with~          EGFRm NSCLC with a secondary T790M mutation (del 19 and T790M or L858R and T790M), and~        -  Cohort 3: Phase 1b evaluation of PF-06747775 in combination with avelumab in~          previously-treated patients with EGFRm NSCLC with a secondary T790M mutation (del 19 and~          T790M or L858R and T790M).~   "
93017|NCT02349620|"~     The main objective of this clinical trial study is to consider the effect of~     Platelet-Rich-Factor (PRF) on implant stability and marginal bone resorption around dental~     implants.~   "
93018|NCT02349607|"~     This study will examine the activity of PF-05089771 and pregabalin, alone and in combination~     on a panel of evoked pain tests carried out from 0.5 to 10 hours following oral dosing in~     healthy male subjects~   "
93019|NCT02349594|"~     To evaluate the effects of infusion of a Fish oil-based lipid emulsion on TNF-α production~     and other relevant immune functions. A soybean oil emulsion, rich in the omega-6~     polyunsaturated fatty acid linoleic acid, will serve as control.~   "
93020|NCT02349581|"~     This is a pilot study of the pectoral nerves block (PECS) in patients with persistent pain~     after breast cancer surgery.~   "
93021|NCT02349568|"~     Multiple reports in the literature showed the efficacy of EUS comparable to ERCP in the~     diagnosis of common bile duct ( CBD ) stone. The EUS-based strategy has provided the cost~     effectiveness in diagnosis of CBD stone in defined patient risk groups was showed in previous~     studies. The aim of our study was to assess the cost effectiveness of EUS based strategy~     versus ERCP based strategy in diagnosis of CBD stones in patients with intermediate risks for~     CBD stones in a real working situation in a developing country.~   "
93022|NCT02349555|"~     This open label study seeks to study the effects of a nutritional supplement on inflammatory~     markers, metabolic parameters, and safety in subjects compared to baseline after taking~     supplement for 2 and 4 months.~   "
93023|NCT02349542|"~     The purpose of this study is to evaluate the serum levels (pharmacokinetics) of bupivacaine~     in a series of patients undergoing simultaneous bilateral total knee arthroplasty with the~     use of a standardized periarticular injection containing free bupivacaine and liposomal~     bupivacaine.~   "
93024|NCT02349529|"~     Children and young people with epilepsy are at increased risk of poorer outcomes related to~     emotional and psychological adjustment, peer relationship problems, lower academic attainment~     and mental health problems across the lifespan. Despite the well understood risks, there~     continues to be a lack of psychological and psychosocial support for young people with~     epilepsy, and a corresponding lack of evidence regarding the effectiveness of psychosocial~     interventions. This study aims to evaluate a manualised psychosocial group intervention for~     adolescents with epilepsy. A cognitive behaviour therapy approach is used, aimed at~     increasing awareness of how epilepsy may impact upon thoughts, feelings and activities and to~     develop strategies for improved psychological adjustment. In addition, an epilepsy knowledge~     component aimed at improving a sense of control and epilepsy self-management is included. A~     group delivery format allows an opportunity for social modelling, and social problem solving,~     helping others and relating to other young people with similar experiences. The social~     learning context and availability of knowledgable facilitators (an epilepsy nurse specialist~     and clinical psychologist) are also key aspects of the intervention. The study will allow us~     to establish a standard manualised group intervention that can be used throughout the UK~     which aims to; establish the effectiveness and desirability of this approach; improve the~     overall quality of life, psychological health and social integration of young people with~     epilepsy; and to improve epilepsy knowledge and selfmanagement skills aimed at maximising~     seizure control and overall management.~   "
93025|NCT02349516|"~     A randomized, controlled study of the safety and efficacy of Squalamine Lactate Eye Drops in~     combination with Ranibizumab intravitreal injections in patients with diabetic macular edema.~     The study duration is 52 weeks and patients will be randomized to one of four treatment arms.~   "
93026|NCT02349503|"~     This is a Phase 1, multicenter, open-label, single-dose study to evaluate the safety and~     tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of NBI-77860 in subjects with~     congenital adrenal hyperplasia (CAH). The study will be conducted in approximately 15~     adolescent females (12-18 years of age) with a documented medical diagnosis of classic~     21-hydroxylase deficiency CAH. The study will include three independent dose cohorts of~     NBI-77860 (approximately 5 subjects per dose cohort). Ascending doses will be evaluated as~     part of a sequential-cohort design.~   "
93027|NCT02349490|"~     Patients with active gastrointestinal bleeding can be included. 5ml of SerasealTM/Fastact~     (Wortham Laboratories, Chattanooga, USA), a CE-certified medical product for in human~     intraoperative use as hemostatic agent, is topically applied via catheters to the bleeding~     site. In group A, Seraseal is applied as initial method for hemostasis. In group B, Seraseal~     is applied after an initial failure of the institutional standard method. Homeostatic success~     is determined by 5 min without bleeding at gastrointestinal site. after application of~     Seraseal.~   "
93028|NCT02349477|"~     This treatment study is a 16-weeks outpatient clinical trial where subjects with alcohol~     dependence will get medication, which might help them to reduce or stop their drinking, or a~     placebo ( placebo is a capsule that looks the same as the investigational drug, but has no~     real medication. It is a sugar pill).~   "
93029|NCT02349464|"~     The purpose of this study is to determine whether a post-hospital discharge lactation support~     system increases preterm infant intake of mother's milk.~   "
93030|NCT02349451|"~     This study is a Phase 2 randomized, double-blind, double-dummy, active- and~     placebo-controlled, parallel-group study designed to assess the safety, tolerability,~     efficacy, pharmacokinetics and immunogenicity of multiple doses of ABT-122 in participants~     with active PsA who are inadequately responding to MTX treatment.~   "
93033|NCT02349412|"~     The study intervention consists of the early integration of palliative care services into~     standard oncology care in an outpatient setting for patients with advanced lung and~     non-colorectal gastrointestinal malignancies who are not being treated with curative intent.~     The palliative care services provided to patients randomized to the intervention will be~     provided by board-certified physicians and/or advanced practice nurses and will focus on the~     following areas: (1) developing and maintaining the therapeutic relationship with the~     patients and family caregivers; (2) assessing and treating patient symptoms; (3) providing~     support and reinforcement of coping with advanced cancer in patients and family caregivers;~     (4) assessing and enhancing prognostic awareness and illness understanding in patients and~     family caregivers; (5) assisting with treatment decision-making; and (6) end-of-life care~     planning.~   "
93034|NCT02349399|"~     The study objectives are to characterize new users of Cyproterone Acetate / Ethinylestradiol~     (CPA/EE) in 2011/2012 and in 2014 according to demographics, treatment characteristics,~     previous diagnosis of acne, hirsutism or other hyperandrogenic conditions, previous acne~     treatment and (concomitant) use of hormonal contraceptives identified in Healthcare Databases~     in the UK (THIN), the Netherlands (PHARMO) and Italy (HSD).~   "
93035|NCT02349386|"~     The objective of this clinical study is to evaluate the safety and efficacy of three~     different doses of BHR-200 (0.36% transdermal estradiol gel) compared to placebo for the~     maintenance of testosterone (T) suppression in men with advanced androgen-sensitive prostate~     cancer.~   "
93036|NCT02349373|"~     Running is a natural part of human locomotion and humans have been running for million of~     years. In modern society, running has become a popular way of exercise and is undertaken by~     many people worldwide, possibly because it provides a cheap and easily accessible form of~     exercise, and the positive effects of running on health and fitness are well known.~     Unfortunately, running is also associated with a high risk of injury.~      The purpose of this project is to investigate how a running schedule which focuses either on~     running distance or running speed influence the overall risk of injury and the types of~     injury sustained in recreational runners.~   "
93037|NCT02349360|"~     The purpose of this research study is to determine the effects of the probiotic,~     Lactobacillus johnsonii N6.2, on safety, gastrointestinal function, wellness, fecal bacteria~     and blood biomarkers in healthy individuals.~   "
93038|NCT02349347|"~     The purpose of this study is to assess the efficacy of intensified intravenous Melphalan in~     combination with a transplant of patients' own blood stem cells for a maximum of three~     cycles.~      In a recently completed small Phase I study looking at the use of higher doses of intravenous~     Melphalan with the combination of lenograstim (a drug that stimulates bone marrow to produce~     white blood cells helping to fight infection) and patients' own blood infusion over 4 cycles~     of treatment has proved encouraging. The results of this study showed rapid improvement in~     pain and a fall in circulating tumour cells within two weeks of starting Melphalan. However,~     slow platelet recovery after the fourth cycle meant longer periods of platelet transfusion.~     For this trial we intend to assess the efficacy of an intensified intravenous Melphalan with~     transplant of patients' own blood stem cells over a shorter time period. This study will~     involve approximately 39 patients over a 3 year period.~   "
93039|NCT02349334|"~     Faecal incontinence occurs when a person passes faeces (stools) without the usual control. It~     is a distressing condition that is actually very common although under-reported because of~     embarrassment. Milder symptoms may be managed by treatments such as dietary change, drugs and~     bowel retraining, but many patients still resort to surgery to improve symptoms. Although~     several operations exist to treat incontinence e.g. those aiming to repair damaged anal~     sphincter muscles, it is now clear that these often have poor results.~      Two relatively new treatments called sacral nerve stimulation (SNS) and percutaneous tibial~     nerve stimulation (PTNS) involve sending pulses of electricity to the nerves controlling the~     bowel and muscles of the anus (anal sphincter).~      SNS does this by inserting electrodes in the lower back just above the tailbone and~     connecting them to an implanted electrical stimulator which is buried in the buttock and acts~     a bit like a heart pacemaker. SNS is a relatively well-established treatment in specialist~     centres, which has been used for over 10 years. It has been shown in studies to be successful~     for faecal incontinence achieving some improvement in at least three quarters of patients. In~     Europe, this procedure is fast becoming first treatment offered when non-surgical treatments~     fail. Nevertheless, SNS is not a miracle cure for all, requiring 2 operations, with potential~     complications and expensive equipment (> £10,000 approx).~      PTNS is a newer treatment, which involves electrically stimulating a nerve at the ankle,~     using a very small needle, as an outpatient (a bit like acupuncture). This sends signals back~     to the spine region to try and improve symptoms of faecal incontinence. Since this is a newer~     treatment, fewer studies have been performed to quantify how successful it is, but early~     results of PTNS suggest that it may be as good as SNS. If this is true, this is very~     important because it is much less invasive and considerably cheaper than SNS (equipment £500~     per patient).~      This project will for the first time determine how effective PTNS is in the treatment of~     patients with faecal incontinence, by comparing it to sham (fake stimulation). This study is~     a properly designed clinical trial of 212 patients in at least 14 UK Specialist Centres.. The~     results of this trial will lead to direct benefits for patients and the NHS.~   "
93040|NCT02349321|"~     Development and evaluation of a multi-faceted school-based intervention to prevent intimate~     partner violence among Grade 8 high school students in South Africa~   "
93041|NCT02349308|"~     The purpose of this study is to demonstrate the stability of blood flow with the CentrosFLO~     catheter, during intermittent dialysis over a period of 6 months after placement.~   "
93042|NCT02349295|"~     The main purpose of this study is to evaluate how effective and safe the study drug known as~     ixekizumab is in participants with active psoriatic arthritis.~   "
93043|NCT02349282|"~     In an ageing population, the need for interventions to help older people remain healthy,~     active and independent for as long as possible, increases. Although several studies suggest a~     beneficial effect of vitamin D3 on maintaining or improving muscle strength and physical~     functioning, particularly in vulnerable populations, results are contradicting. Randomized,~     placebo-controlled trials are needed to further establish the effect of vitamin D on muscle~     strength in the frail elderly population.The primary aim of this study is to determine the~     effect of daily supplementation with two different forms of vitamin D on muscle strength in~     frail elderly people over a period of 24 weeks.~   "
93044|NCT02349269|"~     The aim of the investigators trial was to evaluate association between new onset~     postoperative atrial fibrillation (POAF) and late cardiovascular morbidity and mortality.~   "
93045|NCT02349256|"~     The study uses in depth interviews to understand their experience of somatoform disorder,~     possible explanations and their experience of somatoform disorder, possible explanations and~     their understanding of treatments, especially their ideas about psychosocial treatments.~   "
93046|NCT02349243|"~     This is a randomized, controlled, double blind clinical trial. The purpose of this study is~     to investigate the weight loss efficacy of entacapone. In this study, participants are~     randomly divided into entacapone and placebo groups. The percentage change in body weight,~     the body mass index, waist circumstance, extent of fatty liver, quantity of visceral fat,~     serum insulin, serum triglyceride and the adverse effects are compared between the two~     groups.~   "
93047|NCT02349230|"~     Subjects were randomized into 3 treatment groups (15 subjects per group): 1) Control -~     received no treatment 2) Placebo - received a sham Astym® treatment 3) Astym® Treatment -~     received Astym® treatment to the lower extremity. Subjects were blinded to whether they~     received the Astym® treatment or placebo treatment intervention. After a 5-minute warm-up on~     a lower body ergometer the subjects were familiarized to the operations of a computerized leg~     press machine that measured the maximum force output (Newtons) during a unilateral isometric~     squat test. A baseline measure of maximal force output (pre-test) was determined by the~     average of 3 trials with a 30 second rest period between the trials. The subjects then~     received the designated treatment intervention. Immediately following the treatment~     intervention (0 minutes following treatment intervention) the subjects were retested~     (post-test) using identical testing procedures by an investigator blinded to the treatment~     intervention received by the subject. Maximum force output measured in Newtons for the~     post-test was subtracted from the maximum force output (Newtons) pre-test and then converted~     to a percentage of change [(post-test - pretest)/pretest X 100). The percent change of~     maximal force output from pre-test to post-test measures was compared using a one-way~     analysis of variance with alpha set at 0.05. A Tukey's post-hoc analysis determined~     statistical differences between the groups.~   "
93048|NCT02349217|"~     The goal of this study is to explore the effects of a Mindfulness Based Couples Intervention~     on relationship satisfaction with quality of life and immune system function among breast~     cancer survivors and their partners.~   "
93049|NCT02349204|"~     Music is commonly heard in operating room. The goal of this study is to measure the effect of~     music on surgical performance using a intraocular surgery simulator. The music chosen is~     Sonata for 2 pianos D-440 from Mozart. The participants will complete 2 tasks on the~     simulator, both with and without music, in a randomized sequence. The results will be~     subtracted from the simulator and analyzed.~   "
93050|NCT02349191|"~     This study is a prospective, single arm, non-randomized, interventional study to evaluate the~     safety and effectiveness of Omental transposition (OT) in subjects with early stage AD.~      Within-subjects (repeated-measures) design will be utilized to compare follow-up outcomes to~     baseline.~      The following assessments will be performed at baseline, then at 1, 3, 6, 12, and 24 months~     following surgery:~        -  Montreal Cognitive Assessment (MoCA)~        -  Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog)~        -  General Practitioner Assessment of Cognition (GPCOG)~        -  Eight-item Informant Interview to Differentiate Aging and Dementia (AD8) Subjects who~          have early stage AD confirmed by a neuropsychological test (MoCA) and who are healthy~          enough to undergo surgery.~      The experimental procedure to be performed is omental transposition (OT) surgery. It will be~     performed as a laparoscopic or open procedure for omental lengthening and an open procedure~     for brain access, with a general surgeon performing the omental lengthening/tunneling and a~     neurosurgeon performing brain access/brain biopsy/omental placement on brain.~      Up to twenty-five (25) subjects, with the first 5 subjects being part of a learning curve~     group and the next 20 subjects being part of the experimental group.~      The duration of each subject's participation will be approximately 25 months from screening~     through the 24 month follow-up visit.~   "
93051|NCT02349178|"~     This is a Phase 2 study designed for the purpose of estimating various parameters surrounding~     the efficacy of Clofarabine, Cyclophosphamide and Etoposide in eliminating minimal residual~     disease (MRD) in acute leukemia patients otherwise in remission and without causing~     significant delay of HCT due to treatment related toxicity.~      A single course of bridge chemotherapy is given prior to the transplant procedure as an~     approach to improved disease-free survival in a patient group who historically has had~     inferior outcomes.~   "
93052|NCT02349165|"~     The gold standard corneal crosslinking (CXL) technique involves the initial step of~     epithelial removal, in order to achieve a sufficient treatment effect (meaning: stabilisation~     of progressive keratoconus (KC). Our aim is to evaluate the effects of transepithelial CXL~     (TE-CXL), whereby the epithelium is left intact and the cornea is instead treated by a~     solution composed of 0.1% riboflavin, combined with enhancers, after which standard CXL is~     performed. This solution seems to facilitate riboflavin penetration into the corneal stroma~     through the intact epithelium. The investigators expect to achieve a similar effect of TE-CXL~     with the advantage of a faster healing time and less risk of infections.~   "
93053|NCT02349152|"~     This study evaluates the effect of using remifentanil during cardiopulmonary bypass surgery~     to supress the hyperglycemic response in perioperative period. Half of the participants will~     receive continuous intravenous remifentanil during surgery, while the other half will receive~     intermittent intravenous fentanyl during surgery. Intermittent intravenous fentanyl~     administration is this institution's standard of care.~   "
93054|NCT02349139|"~     This study will be conducted in three parts. Part A is a dose-escalation study to determine~     two safe and tolerable doses of ASN001 for men with metastatic castration resistant prostate~     cancer. Part A will also characterize the pharmacokinetics and pharmacodynamics of the ASN001~     through blood sampling. Subjects in Part B will receive one of two doses identified in Part A~     to determine which one is more effective, and collect additional pharmacokinetic data. Part C~     is an extension for subjects completing either Part A or B.~   "
93055|NCT02349126|"~     Patients with chronic HBV infection will receive ARC-520 in combination with entecavir or~     tenofovir and be evaluated for safety and efficacy.~   "
93056|NCT02349113|"~     This study is being done to study age-related bone changes in women. The investigators know~     that the major cause of osteoporosis is a shortage of the female hormone estrogen. This study~     will look closer at how this shortage of estrogen works to cause a decrease in bone~     formation.~   "
93057|NCT02349100|"~     To determine FDG uptake following uncomplicated EVAR using the Nellix endoprosthesis. Does~     uncomplicated EVAR using the nellix endoprosthesis result in increased FDG uptake and false~     positive PET imaging?~   "
93058|NCT02349087|"~     In Kuopio University Hospital Department of Clinical Neurophysiology there have been designed~     a fast EEG electrode, that is suitable for acute emergency use. This study will address the~     clinical use of acute EEG with this fast EEG electrode in in- hospital patients who have been~     resuscitated due to cardiac arest. After resuscitation patients will be treated in ICU and~     EEG will be recorded for 24 hours.~   "
93059|NCT02349074|"~     Post-cardiac arrest ischemia/reperfusion phenomenon led to organs injury and failure. Among~     the different organs, gastro-intestinal tract injury could contribute to post-cardiac arrest~     shock.~      The ischemic injury of the gastro-intestinal (GI) tractus is suggested by abnormalities in~     digestive biomarkers and by the frequent endotoxemia after CA. However, direct mucosal damage~     has not been clearly demonstrated after OHCA. The real incidence of ischemic lesions of GI~     tract and their potential involvement in the post-CA shock is therefore unknown.~      We propose an original clinical research program aimed at rigorously determining the~     incidence of upper GI lesions after OHCA and analyzing their contribution to the severity of~     post-CA shock through a prospective, interventional, multicentric study~   "
93060|NCT02349061|"~     The purpose of this study is to evaluate the efficacy of ustekinumab as measured by a~     reduction in disease activity for subjects with active Active Systemic Lupus Erythematosus~     (SLE - chronic disorder of connective tissue in which there can be skin rash, arthritis,~     kidney problems, and anemia, among other problems).~   "
93061|NCT02349048|"~     The purpose of this study is to evaluate the efficacy of 6 or 8 weeks of treatment regimen~     containing simeprevir (SMV), daclatasvir (DCV) and sofosbuvir (SOF) in treatment-naive (not~     having received treatment with any approved or investigational drug) participants with~     chronic hepatitis (inflammation of the liver) C virus (HCV) genotype 1 infection with early~     stages of liver fibrosis or with cirrhosis.~   "
93062|NCT02349035|"~     The purpose of this study is to improve prosthesis control for transradial amputees with~     combining targeted muscle reinnervation surgery (TMR) and pattern recognition control.~   "
93063|NCT02349022|"~     The purpose of this study is to compare the diagnostic performance of [89Zr]-Df-IAB2M PET/CT~     with that of [111In]-capromab pendetide as an immuno PET tracer in the detection of prostate~     cancer pre-prostatectomy as confirmed by pathology.~      Individuals participating in this study will have a [111In]-capromab pendetide scan, as well~     as a PET scan following the injection of [89Zr]-Df-IAB2M.~   "
93064|NCT02349009|"~     1:1 active treatment: placebo, blinded trial, evaluating the effect of a 4-week treatment~     period with topical C-82 on skin expression of two gene biomarker surrogates (THBS1 and COMP)~     for the modified Rodnan skin score (MRSS). Study subjects will be randomized to apply the~     active study medication daily for 4 weeks to either the right or left forearm and placebo to~     the contralateral forearm.~   "
93065|NCT02348996|"~     Adequate control of extracellular volume is a major goal of renal replacement therapy in~     patients with chronic renal disease. Fluid overload is present in the early stages of chronic~     kidney disease and contributes significantly to hypertension, arteriosclerosis and high~     prevalence of left ventricular hypertrophy. These are associated with high rates of morbidity~     and mortality in this group of patients, rates on dialysis in Brazil is around17.9 % per~     year. Dry weight during hemodialysis remains a delicate gap between hypervolemia and~     hypovolemic. Many studies have shown that tight control of post - dialysis weight is related~     to better outcomes in short term and higher long-term survival. Many methods have been~     proposed for estimating the hydration status of hemodialysis patients in an objective manner,~     including ultrasonography of the inferior vena cava and echocardiography. However, these~     methods are very time-consuming and cumbersome to use in daily practice. In most dialysis~     centers, the dry weight is evaluated on subjective clinical criteria, with trial and error~     and time consuming. It was recently introduced in Brazil to monitor body composition by~     multifrequency bioimpedance, called Body Composition Monitor ( BCM ) manufactured by~     Fresenius Medical Care. The BCM is a piece of bioimpedance spectrometry using a three~     compartment model, able to quantify objectively and accurately the extracellular volume and~     hydration status of each patient by measuring body resistance to an electric current. The~     procedure is safe, simple and relatively inexpensive. The BCM uses multi-frequency currents~     (ranging from 5 to 1000 KHz ). The availability of this device evaluation of body composition~     which assesses the dry weight more efficiently and objectively determine a target to be~     achieved to prevent left ventricular hypertrophy, hypertension better manage and improve~     cardiovascular outcomes, motivates us to perform this study. So the goal is to compare the~     efficacy between bioelectrical impedance analysis and clinical evaluation for suitability of~     dry weight in hemodialysis patients. A prospective, randomized, crossover study, which will~     include all chronic renal failure patients on hemodialysis at St. Luke 's Hospital (PUC -~     RS), including patients with at least three months on HD and over 18 years of age. The~     expected primary outcome is to achieve greater accuracy in determining the state of hydration~     and dry weight of these patients.~   "
93066|NCT02348983|"~     Being obese can be a risk factor for many health problems, including high cholesterol, high~     blood pressure, low back pain, heart attacks and some cancers. Truckers, who are integral to~     our economy, face challenges that put them at increased likelihood of being obese. The~     investigators want to come up with a program to help drivers get to a healthy weight and stay~     there.~      The WHEEL pilot study is a 12 week weight loss intervention in long-haul commercial truck~     drivers. The study involves two visits to the University of Utah's Rocky Mountain Center for~     Occupational and Environmental Health, one at the start of the study and a second one at the~     end of the study. Both visits include a general health history questionnaire, a 24-hour diet~     recall questionnaire, anthropometric measurements, as well as an assessment of blood~     pressure, hemoglobin A1c, and a cholesterol and lipid panel. Each truck driver is assigned a~     health coach who helps the driver create and achieve three health goals.~      The health coach works with the driver to set individualized goals specific to weight loss,~     and contacts the driver weekly to check in and tweak goals as needed.~      Drivers are also compensated for their participation in the study and get to keep all of the~     intervention materials that the investigators give them. All that the researchers ask is that~     they try their best to have a healthier lifestyle and give us feedback on what they liked and~     didn't like in the study.~   "
93067|NCT02348970|"~     To evaluate the efficacy (non-inferiority) in terms of response between patients using custom~     fitted mandibular advancement devices ONIRIS® and patient using laboratory custom made~     devices TALI, after 2 months of use. Sleeping tests were performed.~   "
93095|NCT02348606|"~     This trial is a 12 week, randomized, double-blind, placebo controlled, multicenter, 5-arm~     parallel group study of safety and efficacy of JZP-110 in the treatment of excessive~     sleepiness in adult subjects with OSA.~   "
93096|NCT02348593|"~     This trial is a 12-week, randomized, double-blind, placebo controlled, multicenter,~     4-treatment parallel group study of the safety and efficacy of JZP-110 in the treatment of~     excessive sleepiness in adult subjects with narcolepsy.~   "
93068|NCT02348957|"~     CML requires ongoing treatment and assessment of treatment milestones in order to manage the~     disease properly. Dasatinib is approved for the treatment of newly diagnosed PH+ CP-CML and~     CML in chronic or accelerated phase or blast crisis in patients resistant or intolerant to~     prior therapies including Imatinib. Although Imatinib has demonstrated unprecedented efficacy~     in clinical trials, mostly in chronic phase CML, there is lack of published data on how CML~     is managed in real-life clinical practice settings. Therefore this non-interventional study~     is designed to collect real-life data on CML-treatment with Dasatinib in clinical routine~     with respect to first and second line treatment and/or switch setting (within 1st line or~     from 1st line TKI to 2nd line Dasatinib). Emphasis lies on health care provided in registered~     doctor's practices as here most of CML patients who are not involved in clinical trials are~     treated.~   "
93069|NCT02348944|"~     The purposes of the study are to assess intra individual biological variability of serum and~     urinary cartilage specific biomarkers and define the best standardized conditions for blood~     and urine sampling in the frame of biomarkers dosage.~   "
93070|NCT02348931|"~     Investigation of the effect of customized nasal braces in the correction of nasal deformities~     with and without prior corrective surgery.~        -  Trial with medicinal product~   "
93071|NCT02348918|"~     A Phase 2 Randomized, Controlled, Double-Masked, Multicenter Clinical trial Designed to~     Evaluate the Safety and Exploratory Efficacy of Luminate® (ALG-1001) as Compared to Avastin®~     and Focal Laser Photocoagulation in the Treatment of Diabetic Macular Edema~   "
93072|NCT02348905|"~     ACTHAR gel has efficacy in the treatment of cutaneous sarcoidosis~   "
93073|NCT02348892|"~     The large share of chronic diseases correlated with an aging population calls to develop~     necessary coordination between the hospital and non-hospital (professional of the city, home~     ...) to create new complementarities.~      Since July 2013, the Nantes University Hospital experiences the establishment of a~     coordinator route patient in Gerontology. The evaluation program of the benefit of~     coordinating the course in elderly patients in health establishment (PROCOPES) must allow to~     prove the efficiency of the intervention of a coordinator route patient, following elderly~     patients in complex situations, both within the hospital and outside the hospital (home,~     nursing home,...). The objective of PROCOPES is to show the added value of an innovative~     position that can make the link between the hospital and the city on deemed complex~     situations.The pilot study results present a strong interest for health care settings,~     nursing home and in the world of research. It will also permit to have preliminary data for~     bigest studies.~   "
93074|NCT02348879|"~     This study is to evaluate the safety of AMG 403 in healthy adult subjects. The study consists~     of a 21 day screening period followed by administration of the investigational product and up~     to 154 day evaluation period.~   "
93075|NCT02348866|"~     This study will determine if there is a difference in bacterial contamination (CFU/cm2)~     between obstetric resident surgical scrubs donned at home and those donned at the hospital.~   "
93076|NCT02348853|"~     U.S. Army Medical Research & Materiel Command Telemedicine and Advanced Technology Research~     Center (TATRC) is sponsoring the HF2 (Healthy Families, Healthy Forces) Study. This is a~     randomized trial comparing two different interventions for sustainable weight loss.~     Specifically, the investigators will compare a current best practice(CBP) intervention that~     includes standard dietary advice with a new, Healthy Weight for Living (HWL) intervention~     that includes recommendations to eat a diet rich in protein, dietary fiber, low glycemic~     index carbohydrates and low calorie foods. The objective of this study is to compare the CBP~     and HWL interventions when delivered to adult dependents of active duty (AD) military~     personnel and measure weight loss effects in both the adult dependents and the AD military~     personnel they live with.~   "
93077|NCT02348840|"~     The purpose of the study is to explore ways to improve maternal and child outcomes in the~     ethnic Maya speaking the Kaqchikel language population, which experiences wide disparities in~     health care access and outcomes when compared to other inhabitants of Guatemala who are not~     ethnically Maya and live in other parts of the country.~   "
93078|NCT02348827|"~     The aim of the present study is to compare an intervention consisting of Family~     Psychoeducation (FPE) to an active control intervention of social support for relatives of~     patients with a diagnosis of major depression.~   "
93079|NCT02348814|"~     The overall aim of this study is to validate a quantitative digital tool for staging liver~     fibrosis in biopsies from chronic human liver diseases and then evaluate it prospectively in~     patients.~   "
93080|NCT02348801|"~     Older people with diabetes will be assigned to the 1-year lifestyle program or no lifestyle~     program while continuing usual treatment for diabetes. The lifestyle program will consist of~     teaching how to practice healthy diet and regular exercise at our facility and continued into~     the community and home. It is hoped that the results would provide convincing proof about the~     usefulness of lifestyle change in older patients with diabetes.~   "
93081|NCT02348788|"~     Both artemether-lumefantrine and chloroquine are currently used and recommended by Malaysian~     Ministry of Health as blood stage treatments for non-severe P. vivax and P. knowlesi malaria.~     Microscopic misdiagnosis between Plasmodium species remains a large issue in Sabah, Malaysia~     and elsewhere. In order to facilitate potential policy change to a unified ACT guideline for~     all malaria species in Sabah artemether-lumefantrine needs to be evaluated for P. vivax~     malaria.~      Preliminary data in a recently completed RCT evaluating artesunate-mefloquine vs chloroquine~     for P. vivax showed up to 36% P. vivax recurrence with chloroquine monotherapy by day 28 post~     treatment without primaquine. Based on these data blood stage chloroquine treatment failure~     rates should also be evaluated in the context of standard concurrent (rather than delayed)~     liver stage primaquine dosing, due to both its potential blood stage synergistic effect in~     addition to known decreased recurrence rates. As artemether-lumefantrine is one of the~     current first line Ministry of Health ACTs used in Sabah with a lower adverse event profile~     compared to artesunate-mefloquine, this was recommended as the more appropriate ACT to~     evaluate against chloroquine.~   "
93108|NCT02348437|"~     The purpose of this study is to determine the functional outcome of repairing the pronator~     quadratus (PQ) muscle in subjects operated for a distal radius fracture (DRF) with volar~     locked plating.~   "
93082|NCT02348775|"~     We have recently reported that older patients with HIV are deficient in glutathione (GSH) due~     to decreased availability of cysteine and glycine, and that oral supplementation with~     cysteine (as n-acetylcysteine) and glycine for 2-weeks corrects their own levels, and~     improves (but does not fully normalize) concentrations of red-cell GSH. We also found that~     when GSH deficient, subjects had impaired mitochondrial fuel oxidation and this improved with~     an increase in intracellular GSH concentrations. These older HIV patients also had~     significant increases in muscle strength with improvement of GSH levels.The current proposal~     in older HIV patients will investigate study if cysteine and glycine supplementation for a~     duration of 12 weeks will result in changes in : (a) GSH levels; (b) body~     composition/anthropometry; (c) strength and function; (d) quality of life; (e) mitochondrial~     energetics; (f) biochemistry (including dyslipidemia and oxidative stress); (g) protein and~     glucose metabolism; (h) cognition and memory. After completing supplementation for 3 months,~     GSH concentrations, strength, function, mitochondrial energetics and neurocognitive tests~     will be measured for a further 2 months to determine the effects of washout.~   "
93083|NCT02348762|"~     The investigators have previously reported that older patients with HIV are deficient in~     glutathione (GSH) due to decreased availability of cysteine and glycine, and that oral~     supplementation with cysteine (as n-acetylcysteine) and glycine for 2-weeks corrects their~     own levels, and improves concentrations of red-cell GSH. The investigators also found that~     when GSH deficient, subjects had impaired mitochondrial energetics and this improved with an~     increase in intracellular GSH concentrations. The current proposal will investigate if~     cysteine and glycine supplementation for a duration of 24 weeks will result in changes in :~     (a) GSH levels; (b) body composition/anthropometry; (c) strength and function; (d) quality of~     life; (e) mitochondrial energetics; (f) biochemistry (including dyslipidemia and oxidative~     stress); (g) protein and glucose metabolism; (h) cognition and memory. 3 months after~     completing supplementation, measurement of GSH concentrations, strength, function,~     mitochondrial energetics and neurocognitive tests will be done to determine the effects of~     washout.~   "
93084|NCT02348749|"~     The purpose of this study is to see how a new tracer named 18F-MFBG (Meta Fluorobenzyl~     Guanidine) behaves in the body after injection, how it spreads to all the organs and how it~     is removed from the body. We will also study how long 18F-MFBG lasts in the blood after~     administered. In addition we want to study if 18F-MFBG can show Neuroendocrine tumors on a~     PET-CT scan.~   "
93085|NCT02348736|"~     A randomized controlled prospective study of laryngoscopy and intubation time comparing~     SensaScope and the McGrath® Series 5 video laryngoscope.~   "
93086|NCT02348723|"~     The primary objective of this trial is to assess the safety of an uninterrupted dabigatran~     etexilate periprocedural anticoagulant regimen compared to an uninterrupted warfarin regimen~     in Non-Valvular Atrial Fibrillation (NVAF) patients undergoing Atrial Fibrillation (AF)~     ablation in a PROBE (Prospective, randomized, open label, blinded end point) active~     controlled study.~      Secondary objectives are to assess additional safety endpoints and efficacy in this clinical~     setting.~      It is not intended to assess confirmatory hypothesis, this is an exploratory study.~   "
93087|NCT02348710|"~     This randomized controlled trial will test a multicomponent intervention to increase exercise~     Outcome Expectations (OEs) and assess effects of OE changes on exercise intentions and levels~     of exercise. Sixty early stage breast cancer survivors will be recruited from the Duke Cancer~     Institute. Participants will be randomized to the exercise OE intervention or an attention~     control group. Both groups will receive the American Cancer Society diet and exercise~     guidelines and an accelerometer. The intervention group will also receive an OE workbook~     containing self-directed activities to increase OEs by focusing on OE importance (value~     placed on the outcome(s)), certainty (perceived probability outcome(s) will occur); and~     accessibility (frequency with which the outcome(s) are thought of). The attention control~     group will receive a workbook containing the same activities focused on diet, rather than~     exercise.~   "
93088|NCT02348697|"~     Non-interventional study to evaluate safety and efficacy of NOVOCART 3D in adult and~     adolescent patients with full thickness cartilage defects after the treatment with NOVOCART~     3D.~   "
93089|NCT02348684|"~     The association between radiation exposure and cardiac disease is well recognized, it is not~     fully understood if there exists an optimal or safe radiation dose-volume relationship.~   "
93090|NCT02348671|"~     The purpose of this study is to investigate if wound dressings are capable in reducing the~     effects of shear- force at the skin. With our own shear- force model we are able to apply 19~     Newton shear- force combined with 9 newton pressure at the skin of the non- dominant forearm.~     After half an hour we measure IL-1alpha/ total protein- ratio, cutaneous blood flow (Laser~     doppler, Moor LDI) and the erythema index (DSMIIColormeter) which occurs as an effect of~     shear- force application at the skin.~      Then, we apply 19 Newton shear- force combined with 9 Newton pressure at the dominant~     fore-arm but this time we put a wound dressing between the skin and shear- force model. After~     half an hour we measure the IL-1alpha/total protein-ratio, cutaneous blood flow and the~     erythema index.~      This research consists of three research day, each day we are going to investigate a~     different wound dressing~   "
93091|NCT02348658|"~     This is a phase 1, randomized, open-label, crossover study to evaluate the food-effect of~     single oral dose of TAK-536TCH final formulation tablet in healthy adult male participants.~   "
93092|NCT02348645|"~     The purpose of this study is to assess the feasibility of a full-scale multicenter~     randomized, controlled trial comparing the effectiveness of two surgical treatments for a~     condition associated with lumbar spinal stenosis called degenerative lumbar~     spondylolisthesis. Both treatments are currently used, but individual surgeons use different~     selection criteria for each treatment and use the procedures at different rates. The two~     procedures are decompression with fusion (the most common surgical procedure for~     spondylolisthesis) and midline-sparing decompression alone (which is also a standard~     treatment, but is not as widely used for treating spondylolisthesis). The investigators plan~     to collect the evidence on the following:~        1. The feasibility of the trial protocol, and~        2. Preliminary data on the effectiveness of each treatment.~   "
93093|NCT02348632|"~     This is a Phase 3 study to assess the long-term safety and maintenance of efficacy of JZP-110~     in subjects who have completed Study 14-002, 14-003, 14-004, 15-004, 15-005, ADX-N05 201, or~     ADX-N05 202.~   "
93097|NCT02348580|"~     The study uses experimental methods to evaluate the effectiveness of an educational~     intervention in Rwanda. The intervention, designed by Aflatoun and AMIR, involves training~     teachers on the use of active-learning methods to implement a social and financial education~     curriculum with students in primary and secondary schools. Teachers then implement the social~     and financial curriculum with students in order to improve their personal, social, and~     financial competencies.~      Teacher training will take place in November-December 2013 and the curriculum implementation~     will be evaluated in the 2014 school year.~      The study will examine the following hypotheses:~        1. Did teachers use of active learning methods in class increase due to the training~          received?~        2. Did students' levels of engagement and on-task behaviour increase as a result of the~          intervention's pedagogy and content?~        3. Did the following competencies of students improve due to the intervention?~             1. Self-efficacy~             2. Social skills~             3. Financial literacy~             4. Planning attitudes~             5. Savings attitudes~             6. Savings behavior~             7. Entrepreneurship~        4. Did the intervention change student's pass rates on the primary six (P6) and secondary~          three (S3) final examinations for the classes in which it was implemented?~        5. Did the intervention change student drop out rates in the classes which it was~          implemented?~   "
93098|NCT02348567|"~     Introduction: Accreditation programmes for healthcare systems have been implemented in more~     than 70 countries to stimulate high-quality organisational performance. Several Danish~     healthcare institutions are covered by the Danish Healthcare Quality Programme (DDKM) and all~     Danish public hospitals have been accredited according to the DDKM since 2010.~      The dates of each survey are currently being announced 8-10 months beforehand. Announcing~     surveys has been criticised for creating an arranged reality. It has therefore been~     suggested that a national intervention be conducted to evaluate the effect of unannounced~     hospital surveys.~      Methods and analysis: All public somatic and psychiatric hospitals in Denmark (n=30) were~     invited to participate in the trial. Twenty-three hospitals (77%) (3 university hospitals, 5~     psychiatric hospitals, and 15 general hospitals) agreed to participate and to be randomised~     to one of the trial clusters. Eleven hospitals will receive announced surveys (control group)~     and 12 hospitals will receive unannounced surveys (intervention group).We hypothesise that~     hospitals receiving unannounced surveys will be rated as less successful than hospitals~     receiving announced surveys, defined as meeting less compliance with accreditation standards~     and performance indicators. Nine experienced surveyors employed and educated by The Danish~     Institute for Quality and Accreditation in Health Care (IKAS) will be responsible for~     conducting the surveys according to an abbreviated version of the current Danish periodic~     survey. The outcome is compliance with indicators reflecting organisational performance.~     Compliance will be analysed using logistic or linear regression analysis with random effects,~     contingency tables, and Pearson's chi-squared test or Fishers exact test, whichever is most~     appropriate.~      Ethics and Dissemination: This trial is pending ethics approval from Research Ethichs Comite~     for North Denmark Region. The findings from this randomised controlled trial will be~     disseminated through peer-reviewed journals, national and international conferences and will~     be utilised as health care political decision making for the future national accreditation~     programme. In addition, the results will facilitate to validate the effect of unannounced~     hospital surveys; given the issues of currently meeting an arranged reality during hospital~     surveys, this seems extremely desirable.~   "
93099|NCT02348554|"~     The aim of this study was to validate functions for estimating energy expenditure in~     controlled and free-living conditions. This method was based on accelerometry data acquired~     from smartphones worn in a trouser pocket. The developed functions have been compared to the~     estimations provided by three research devices named Fitmate, Armband and Actiheart.~   "
93100|NCT02348541|"~     Assess the feasibility of CollaGUARD following Hysteroscopic Adhesiolysis.~   "
93101|NCT02348528|"~     CC5013-MM024 is a multicenter, open-label, Extended Access Program (EAP) of lenalidomide plus~     low dose dexamethasone regimen in Chinese subjects with relapsed or refractory MM who~     participated in Study CC-5013-MM-021. For subjects who remained progression free under Rd~     treatment of Study CC-5013-MM-02 1, this LAP offers the option to continue lenalidomide~     treatment for subjects who have shown therapeutic benefit.~   "
93102|NCT02348515|"~     Recent evidence of a potential role for cardiac progenitor cells (CPCs) in cardiac repair and~     the discovery of a vasoprotective axis of the renin-angiotensin system (RAS) offer such~     breakthroughs. Investigators have observed that an imbalance in the vasoprotective axis~     {angiotensin converting enzyme 2 (ACE2)/angiotensin-(1-7) [Ang-(1-7)]/Mas receptor} and the~     vasodeleterious axis [angiotensin converting enzyme (ACE)/angiotensin II (AngII)/AngII type 1~     receptor (AT1R)] of the RAS within the CPCs affects their functionality and regenerative~     potential. Investigators believe that restoring the balance between these two axes of the RAS~     is essential to improve CPC function and enhance their reparative capabilities. These~     observations have led to the hypothesis that genetic modification of CPCs by overexpression~     of ACE2/Ang-(1-7) will enhance their reparative function and improve their potential to~     attenuate myocardial ischemia-induced cardiac damage.~   "
93103|NCT02348502|"~     Chronic hepatitis B (CHB) is a serious liver disease worldwide, and the leading cause of~     cirrhosis and hepatocellular carcinoma (HCC). HBsAg loss/seroconversion is considered to be~     the ideal endpoint of antiviral therapy in both HBeAg-positive and -negative patients, and~     the ultimate treatment goal in CHB, However HBsAg loss occurred rarely by interferon~     treatment. Although It was reported that in nature history HBsAg level≤100 IU/ml can bring~     good long term outcomes in patients with chronic hepatitis B. it was not clear whether~     patients who achieved HBsAg level≤100 IU/ml by interferon treatment could maintain sustained~     viral response and the state of HBsAg level≤100 IU/ml.~   "
93104|NCT02348489|"~     To compare efficacy and safety between SGI-110 and Treatment Choice in adults with previously~     untreated AML who are not considered candidates for intensive remission induction~     chemotherapy.~   "
93105|NCT02348476|"~     This study is a retrospective chart review to assess the tolerability and efficacy of~     treatment with Simbrinza™ used for patients with Open-Angle Glaucoma or Ocular Hypertension.~   "
93106|NCT02348463|"~     Bacterial vaginosis (BV) is a known risk factor for preterm delivery. This study was~     conducted in an attempt to investigate if treatment of bacterial vaginosis in early pregnancy~     could reduce the risk for preterm delivery.~      Women were screened for bacterial vaginosis during the first visits at the maternal health~     care unit with a vaginal sample that were taken by the midwife or by herself. After the~     vaginal samples was air dried it was sent to the gynaecological department and was~     investigated using Hay/Ison classification. Eligible women were those who had lived in~     Skaraborg and delivered at Skaraborg hospital.~   "
93107|NCT02348450|"~     This study is aimed to evaluate the progression-free survival(PFS) and also survival of IP~     and EP (head-to-head) as the first line therapy for extensive stage small-cell lung cancer~     and to explore the reasonable first-line therapy for Chinese population. An open-label,~     multi-center study will be conducted with dynamic randomization of approximately 1:1 ratio~     with an estimation of 308 eligible participants.~   "
93109|NCT02348424|"~     This is an open-label Phase I study of plasma, genitourinary, rectal, and pharyngeal~     pharmacokinetics of a single 1000mg oral dose of solithromycin. Study Objectives: The primary~     objective is to determine the pharmacokinetics of solithromycin in plasma, vaginal, cervical,~     seminal, rectal, and pharyngeal fluid samples after a single 1000mg oral dose.~   "
93110|NCT02348411|"~     The purpose of this study is to evaluate the safety and initial effectiveness of MRI-guided~     focused ultrasound thermal ablation of a designated area in the brain of patients suffering~     from medication-refractory MDD, using the ExAblate transcranial system.~      The ExAblate system is a medical device that involves a focused ultrasound system and an MRI~     scanner. ExAblate delivers a pulse of focused ultrasound energy, or sonication, to the~     targeted tissue. For MDD Patients: one or more thermal lesion will be created on Bilateral~     Anterior Limb of internal Capsule.~      The treatment begins with a series of standard diagnostic MR images to identify the location~     and shape of target to be treated. The ExAblate computer uses the physician's designation of~     the target volume to plan the best way to cover the target volume with small spots called~     sonications. These treatment spots are cylinder shaped. Their size depends on sonication~     power and duration. During the treatment, a specific MR scan, which can be processed to~     identify changes in tissue temperature, provides a thermal map of the treatment volume to~     confirm the therapeutic effect. The thermal map is used to monitor the treatment in progress,~     and confirm that the ablation is proceeding according to plan, thus closing the therapy loop.~      The ExAblate transcranial operates a helmet-shaped transducer (currently utilizing~     1000-element phased array transducer) positioned above the subject head. The ExAblate~     transcranial system also includes means to immobilize the subject head, cool the interface~     water, and software for CT analysis and phase correction computation.~      After informed consent and screening, eligible subjects will proceed to the treatment. All~     subjects will be followed at Day 1, 7 days, 1 month , and 6 months . At follow up visits,~     patients will be evaluated for general health, neurological changes (including MMSE exam),and~     efficacy measurements as well as for device/procedure related adverse events that may have~     occurred during the follow-up period. Six (6) month follow up visit will also include Full~     Battery Cognitive/Neurological Testing~   "
93111|NCT02348398|"~     The goal of this clinical research study is to learn if the combination of topotecan and~     pazopanib can help to control recurrent cervical cancer. The safety of the study drug~     combination will also be studied.~   "
93112|NCT02348385|"~     The goal is to examine sex differences in amphetamine-induced dopamine release in tobacco~     smokers and nonsmokers.~   "
93113|NCT02348372|"~     GSK1278863A is a novel small molecule agent, which stimulates erythropoiesis through~     inhibition of hypoxia-inducible factor (HIF)-prolyl hydroxylases (EGLNs). This compound is~     being developed for the treatment of anemia. This study, PHI115385, will be the first~     administration of GSK1278863A to Japanese subjects to investigate the safety, tolerability,~     pharmacokinetics, and pharmacodynamics of single oral doses in healthy Japanese adult~     subjects. Healthy Caucasian adult subjects will be included in order to compare~     pharmacokinetics of GSK1278863A and its metabolite(s), and pharmacodynamics of GSK1278863A.~   "
93114|NCT02348359|"~     The purpose of this study is to evaluate the safety and efficacy of X-82 in the treatment of~     vision loss due to wet AMD.~   "
93115|NCT02348346|"~     Environmental cleanliness As antimicrobial resistance is a major and overall deteriorating~     public health problem international cooperation is necessary. Continued progress is needed to~     implement and improve programmes for the prevention and control of antimicrobial resistance~     and HAIs.~      Environmental cleanliness might be one of the most important initiatives to reduce HAIs.~     Hospital surfaces are heavily contaminated with bacteria with the highest numbers on surfaces~     closest to the patients. Bed rails, nurse call buttons, curtains, towel dispensers, door~     handles, sinks, floors, clinical information stations, medical devices, stethoscopes, staff~     toilets etc. Actually, general hospital wards and Intensive Care Units are loaded with an~     abundance of potential pathogens 8,9,10. Surviving days, weeks or even months in the~     environment 11. Colonizing patients with bacteria from the hospital environment and getting~     HAIs or even die.~      As most ventilator-associated pneumonias (VAPs) are the result of nosocomial microorganisms~     the environment plays an important role in the acquisition of pathogenic bacteria by~     contaminating health care workers hands and equipment 12,13. Furthermore, ICUs and wards~     struggle with colonized patients with ESBL-bacteria from sinks eventually leading to dead or~     outbreaks of group A streptococcus infections from contaminated curtains 14,15.~      As key healthcare-associated pathogens have the capacity to persist for weeks to months on~     hospital surfaces indirect transmission is a serious threat, especially as antimicrobial~     resistance increases. Hospitalization in a room in which the previous patient had been~     colonized or infected with nosocomial pathogens (e.g. MRSA, VRE, multidrug-resistant~     Acinetobacter, Pseudomonas or C. difficile) has been shown to be a risk factor for~     colonization of infection with the same pathogen for the next patient16. Furthermore, the~     most important risk factor for hand and glove contamination of healthcare workers with~     multidrug-resistant bacteria has been demonstrated to be positive environmental cultures 17.~     To decrease the frequency and level of contamination of environmental surfaces the Centre for~     Disease Control and Prevention recommends routine disinfection of medical equipment and~     environmental surfaces to prevent the spread of potential pathogens through the hospital ward~     or ICU 18. Improved room cleaning has shown to decrease the risk for MRSA, VRE and C.~     difficile acquisition. Unfortunately, environmental cleaning is frequently inadequate. Less~     than 50% of hospital room surfaces are adequately cleaned and disinfected even by~     environmental services personnel. Environmental services personnel have low wages, are under~     time pressure to clean rooms quickly with high turn-over rates of patients. Novel materials~     and cleaning technologies have been developed as ultraviolet germicidal irradiation (UVGI) or~     hydrogen peroxide vapor (HPV). However, both technologies are expensive and can just be used~     for terminal cleaning and not during routine daily care 16. Self-disinfecting surfaces may~     overcome these problems. Once applied antimicrobial surfaces will continuously reduce the~     bioburden of nosocomial pathogens preventing transmission and decrease HAIs.~      MVX One of these self-disinfecting products is MVX. MVX contains titanium dioxide which by~     the use of nanotechnology is now available for use in the health sector. Working as a~     photocatalyticum it generates, in the presence of light, hydroxy radicals and oxygen radicals~     for at least five years after coating hospital surfaces (durability test TUV Rheinland).~     Laboratory tests show that MVX is effective in killing bacteria, viruses and fungi (see~     attachment 1 for summary test results).~      The positive results reported on the effects of MVX from laboratory evaluations still have to~     be confirmed in the clinical setting. After getting the CE-marking Gelderse Vallei Hospital~     in Ede, the Netherlands, will be the first hospital in Europe to study the efficacy of MVX in~     the Intensive Care Unit (ICU).~   "
93116|NCT02348333|"~     The purpose of this study is to assess the safety, tolerability, pharmacokinetics and~     pharmacodynamics of 7-day-repeated doses of FYU-981 administered orally to healthy male~     adults once daily. Participants are randomized to placebo (n=3) or FYU-981 (n=6) in each~     step. After follow-up examination in the step of lower dose, the next dose is administered.~   "
93117|NCT02348320|"~     This is a phase 1 open-label study to evaluate the safety and immunogenicity of a~     personalized polyepitope DNA vaccine strategy. The personalized polyepitope DNA vaccines will~     be formulated as naked plasmid DNA vaccines. The hypothesis of this study is that~     personalized polyepitope DNA vaccines will be safe for human administration and capable of~     generating measurable CD8 T cell responses to mutant tumor-specific antigens.~   "
93118|NCT02348307|"~     The purpose of this study is to assess the safety, tolerability, pharmacokinetics and~     pharmacodynamics of single doses of FYU-981 administered orally to healthy male adults in~     fasted and fed conditions. Participants are randomized to placebo (n=3) or FYU-981 (n=6) in~     each step. After follow-up examination in the step of lower dose, the next dose is~     administered. The effect of food on PK/PD of FYU-981 is also investigated.~   "
93119|NCT02348294|"~     1. The objective of this study is to acquire knowledge about the development of reactive~          hyperaemia and inflammatory responses of the skin after shear- force and pressure~          loading. We want to investigate if patients with diabetes type 2 will develop more skin~          damage, because of a decreased microvascular function.~        2. The second objective of this study is: to investigate if the cytokine production of the~          skin is increased in patients with type 2 diabetes with a history of Charcot~          osteoarthropathy in comparison with patients with neuropathy without a history of~          Charcot osteoarthropathy.~      The participant is asked to put his left arm on a support cushion. Then we mark an area of~     2.5 cm x 3 cm with a permanent marker at the plantar aspect of the left fore-arm and the~     adhesive side of a Sebutape is placed within this area for collection of IL-1α/ total protein~     concentrations in a non- loaded situation (event 1) for two minutes. Second, we measure the~     cutaneous blood cell flux within the borders of the marked area with a Laser doppler.~     Finally, we measure the erythema index in this area with a colorimeter. Then we place the~     shear- pad over the marked area we apply 9,8 Newton (N) pressure with 19 N shear- force for~     half an hour. After this period a new Sebutape is placed for two minutes, followed by~     cutaneous blood cell flux and the erythema index measurement within the borders of the marked~     area. We repeat these measures after 15 minutes, 30 minutes, 45 minutes and 60 minutes, At~     the same time we performed the same experiment at the right arm, but instead of loading this~     arm with shear- force and pressure, we apply only 9,8 N pressure at this arm. The same~     measures with the sebutape, laser doppler and colorimeter are done before and after loading~     of the skin. The measures are repeated at 15 minutes, 30 minutes, 45 minutes and 60 minutes.~   "
93120|NCT02348281|"~     This prospective, single center, phase II study is to evaluate the efficacy and safety of~     bicalutamide as a treatment in androgen receptor (AR)-positive metastatic triple-negative~     breast cancer (mTNBC) patients.~   "
93121|NCT02348268|"~     Mechanical neck pain is a musculoskeletal disorder usually associated with work absenteeism.~     Myofascial release therapy (MRT) is currently under development and has the treatment of~     mechanical neck pain as one of its main focal points. However, there is a paucity of studies~     reporting its effectiveness. For that purpose a randomized single-blind parallel group study~     was designed to compare the effectiveness of MRT with manual therapy (MT) for treating~     occupational mechanical neck pain. The sample (n=59) was randomly assigned to two therapeutic~     intervention programs. Group I patients were treated with MT and Group II patients were~     treated with MRT. Variables studied were intensity of neck pain, cervical disability, quality~     of life (QoL), craniovertebral angle and ranges of cervical motion.~   "
93157|NCT02347787|"~     This is a multi-center randomized controlled trial comparing the effectiveness of community~     health worker (CHW) vs. usual clinician support in helping chronically-ill patients with low~     socioeconomic status to improve their health outcomes.~   "
93158|NCT02347774|"~     This is a trial of 12 weeks of treatment with nebulized SUN-101 using an Investigational~     eFlow® Closed System (CS) nebulizer in subjects with chronic obstructive pulmonary disease~     (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD 2014)~     guidelines.~   "
93122|NCT02348255|"~     This phase II trial studies the safety of NovoTTF-100A in combination with bevacizumab and~     carmustine and to see how well they work in treating patients with glioblastoma multiforme~     that has returned for the first time. NovoTTF-100A, a type of electric field therapy,~     delivers low intensity, alternating wave-like electric fields that may interfere with~     multiplication of the glioblastoma multiforme cells. Monoclonal antibodies, such as~     bevacizumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in~     chemotherapy, such as carmustine, work in different ways to stop the growth of tumor cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Giving NovoTTF-100A together with bevacizumab and carmustine may be an effective~     treatment for glioblastoma multiforme.~   "
93123|NCT02348242|"~     60% of the patients hospitalized in intensive care and sedated suffer from insufficient~     inferior eyelid occlusion. Thus, they are at risk for corneal damage (estimated risk 20% to~     57%). The prevention of such corneal damage can be done using several techniques (artificial~     tears, eyelid occlusion dressing, aqueous gel). The efficacy of these techniques has never~     been compared in a rigorous study. Therefore it is not yet possible to determine an~     evidence-based strategy to prevent corneal damage in intensive care patients.~      This study aims at assessing the efficacy of primary prevention of corneal lesions in~     intensive care patients, in order to elaborate an evidence-based nursing protocol.~   "
93124|NCT02348229|"~     The investigators designed a prospective randomized, controlled clinical trial then recruited~     149 consecutive advanced gastric cancer patients. Further divided into a ERAS group (n=73)~     and a conventional pathway group (n=76). Surgical technique in both groups was same~     laparoscopic-assisted gastrectomy with D2 lymphadenectomy. Compared outcomes included~     clinical parameters and serum indicators.~   "
93125|NCT02348216|"~     This is a single arm, open-label, multi-center, phase 1/2 study, to determine the safety and~     efficacy of KTE-C19, an autologous anti-CD19 chimeric antigen receptor (CAR)-positive T cell~     therapy, in refractory aggressive Non-Hodgkin Lymphoma (NHL).~   "
93126|NCT02348203|"~     This randomized phase II trial studies the effects of aspirin and zileuton on genes related~     to tobacco use in current smokers. Aspirin and zileuton may interfere with genes related to~     tobacco use and may be useful in preventing lung cancer in current smokers.~   "
93127|NCT02348190|"~     The overall objective of the current proposal is to strengthen the putative link between FFA~     induced insulin resistance and atherosclerotic vascular disease (ASVD). To this end, the~     investigators will test the following hypotheses: 1) that FFA induced activation of protein~     kinase C βII (PKC β II) and δ and other serine kinases such as IκB kinase (IKK) in human~     muscle is associated with a decrease in insulin stimulated tyrosine phosphorylation of the~     insulin receptor substrate-1 (IRS-1) and of IRS-1 associated phosphatidylinositol 3 (PI3)~     kinase; 2) that these changes precede the development of insulin resistance; 3) that the~     decrease in IκB-α results in activation of nuclear factor κB (NFκB) and the expression of~     adhesion molecules and cytokines; 4) that PKC and IKK are involved in producing insulin~     resistance and activation of the IκB/ NFκB pathway and lastly 5) that the same mechanisms~     operative in healthy volunteers are also operative in patients with T2DM.The investigators~     will test these hypotheses in normal (current) and diabetic volunteers (previously completed)~     . Euglycemic-hyperinsulinemic clamps will be performed with and without co-infusion of lipid~     plus heparin (to raise FFAs) and by obtaining serial muscle and fat biopsies and blood~     samples will be obtained for measurement of substrates, hormones, enzymes and metabolites.~   "
93128|NCT02348177|"~     The purpose of this study is to determine the lopinavir levels in blood of HIV and TB~     infected children (3-15kg) when given lopinavir/ritonavir in a 1:1 ratio with rifampicin~     containing TB regimen and its safety.~   "
93129|NCT02348164|"~     The goal of the research study is to measure and compare the absorption of equivalent amounts~     of beta-cryptoxanthin and Iycopene provided in citrus fruit. The investigators want to~     determine whether adults absorb beta-cryptoxanthin to a greater extent than lycopene, when~     both are supplied in comparable citrus fruits.~   "
93130|NCT02348151|"~     It is still not clearly known whether doing the walk test in a course is different from doing~     it on a treadmill in the lack of a ten-meter-long corridor. In case of a positive outcome in~     this study, we will have an alternative for this test in places where there is not enough~     room, benefiting the assessment of COPD patients' functional capacity. In the literature,~     there are still some controversies about performing the test on a treadmill or in a corridor~     and whether there is interference with the distance walked. Our hypothesis is that there is~     no interference with the distance walked, and thus we have one more option to perform the~     test in case there is no 10-meter corridor available.~   "
93131|NCT02348138|"~     The main purpose this study is to analyze the effects of isometric handgrip training on~     cardiovascular risk in hypertensive. For this, approximately 60 hypertensive, under~     anti-hypertensive medication, will be selected and randomly distributed into three groups:~     home-based isometric handgrip training (HBT), supervised isometric handgrip training (ST) and~     control group (CG).Subjects assigned to the HBT and ST will train three times per week for a~     total of 12 weeks, will perform a bout of isometric handgrip exercise: four sets of 2-min~     isometric contractions (using alternate hands) at 30% of maximal voluntary contraction.~     However, the subjects of the HBT group conduct the training without daily supervision.~     Subjects randomized to the CG will be encouraged to increase the level of physical activity~     and make healthy eating, without, however, receive specific recommendations.Baseline and~     after 12 weeks of intervention, the following cardiovascular risk indicators will be~     obtained: blood pressure, arterial stiffness, cardiac autonomic modulation, vasodilatory~     capacity and oxidative and inflammatory stress markers, in addition to microalbuminuria. For~     data analysis, in addition to descriptive statistics, two-way ANOVA for mixed model will be~     applied for within and between groups comparison. If the premises of this test are met. The~     level of significance that will be adopted is p<0.05.~   "
93159|NCT02347761|"~     This is a trial of 12 weeks of treatment with nebulized SUN-101 using an Investigational~     eFlow® Closed System (CS) nebulizer in subjects with chronic obstructive pulmonary disease~     (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD 2014)~     guidelines.~   "
98622|NCT02276352|"~     Study to assess the relative bioavailability of two 7.5 mg meloxicam tablets (American type)~     compared to one 15 mg meloxicam tablet (American type), and to investigate~     dose-proportionality over the dosage range 7.5 mg to 15 mg~   "
93132|NCT02348125|"~     In this study, 50 children between 3 and 12 years old with formally diagnosed autistic~     spectrum disorders (ASD) and also having significant mitochondrial dysfunction will be~     treated for a 3 month period with the Mitochondrial Cocktail, a combination of specific~     nutritional supplements and metabolite intermediates (including anti-oxidants) and bio-energy~     substrates. A series of neurological and psychological evaluations will be conducted by~     trained evaluators/clinicians to evaluate both the severity and the clinical presentation of~     the ASD/mitochondrial dysfunction with each subject at baseline prior to treatment, after the~     3 month treatment and again at 6 months, after another 3 month non-treatment period. In~     addition, laboratory investigations will be conducted at the same time-points to assess the~     mitochondrial dysfunction and cellular biomarkers thought to be associated with autistic and~     mitochondrial disorders. These investigations will include the analysis of samples of blood~     and cheek/buccal swabs collected from each child to assess select biochemical markers of ASD.~     The Mitochondrial Cocktail treatment will be administered at home once a day continuously for~     a total of 3 months. All the children in the study will be treated with the same~     Mitochondrial Cocktail (an open label study).~   "
93133|NCT02348112|"~     The aim of this postmarket study is to compare the safety and effectiveness of the Altis~     Single Sling (SIS) to an FDA cleared transobturator and/or retropubic sling through 36~     months.~   "
93134|NCT02348099|"~     This is a pilot study to enroll 100 people to assess the incidence of lipohypertrophy as~     detected with ultrasound and its impact on glycemic variability.~   "
93135|NCT02348086|"~     The purpose of this study is to determine the impact that treatment with a cellular~     concentrate derived from an individual's own fat, known as the stromal vascular fraction~     (SVF), has on pain and functionality in people with rheumatoid arthritis (RA). SVF contains~     multiple cellular components, including stem cells, with both regenerative and~     anti-inflammatory properties. This therapy has shown promise for ameliorating the symptoms of~     RA. This study is designed to evaluate changes in pain and functionality in individuals with~     RA for up to 12 months following SVF treatment.~   "
93136|NCT02348073|"~     Our project aims to develop a new therapeutic approach in epilepsy-associated attention~     disorders in children, through evaluation of the clinical impact of dietary n-3 fatty acids,~     containing eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) conjugated to a~     phospholipid vector. The primary objective is to evaluate the efficacy of a PUFA~     supplementation (PS-Omega 3), after 12 weeks of treatment, on attention disorders in children~     with epilepsy. Secondary objectives include:~        -  To evaluate the impact of a supplementation of PS-Omega 3 on quality of life.~        -  To evaluate the impact of a supplementation of PS-Omega 3 on serum and erythrocyte lipid~          profiles.~        -  To assess the tolerance of a supplementation of PS-Omega 3.~        -  To assess the impact of a supplementation of PS-Omega 3 on the frequency of seizures.~        -  To describe the impact of a supplementation of PS-Omega 3, at 24 weeks,~             1. on attention disorders in children with epilepsy,~             2. on quality of life,~             3. and on serum and erythrocyte lipid profiles. This study will recruit 272 subjects~               aged 6- 16 years, suffering from epilepsy (any type) and attention deficit~               hyperactivity disorder (ADHD) (inattentive or combined type) according to DSM V~               criteria in 12 clinical sites in France.~   "
93137|NCT02348060|"~     The purpose of this study is to determine the impact that treatment with a cellular~     concentrate derived from an individual's own fat, known as the stromal vascular fraction~     (SVF), has on the quality of life of people with chronic obstructive pulmonary disease~     (COPD). SVF contains multiple cellular components, including stem cells, with both~     regenerative and anti-inflammatory properties. This therapy has shown promise for~     ameliorating the symptoms of COPD. This study is designed to evaluate quality of life changes~     in individuals with COPD for up to 12 months following SVF treatment.~   "
93138|NCT02348047|"~     Compare ventilation parameters in Adaptative Support Ventilation mode to conventional mode,~     on intubated, ventilated and sedated patients, during their secondary transfer from an~     hospital to another, by a SMUR team.~   "
93139|NCT02348034|"~     The study will explore the ability of negative pressure wound therapy (Prevena dressing) to~     reduce post operative superficial surgical site infection rate in elective colorectal~     surgery. Half of the participants will receive Prevena dressing on closed incision~     immediately after the operation while other half will receive conventional surgical dressing.~   "
93140|NCT02348021|"~     Prospective, multi-center, non-randomized, open-label trial designed to enroll 139 patients~     in Japan. All patients will receive a DCS and will be followed for 2 years.~   "
93141|NCT02348008|"~     This is an open label, multi-institutional, single arm study of dose escalation phase Ib~     cohort, followed by a phase II cohort of anti-PD-1 antibody MK-3475 in combination with~     bevacizumab. No randomization or blinding is involved.~   "
93142|NCT02347995|"~     Stroke survivors experience severe muscle wasting during the chronic phase of recovery, with~     implications for strength, function and general health. Although resistive exercise training~     effectively combats this problem, it is unknown whether sub-optimal protein intake limits the~     observed gains in skeletal muscle growth. Skeletal muscle adaptations may occur when~     resistive training (RT) is combined with nutritional therapy in the form of post- exercise~     protein consumption. This study would be the first to directly compare RT+protein~     supplementation to RT+placebo (same calories as protein supplement) in those with chronic~     hemiparesis caused by stroke, providing evidence-based rationale for combination therapy in~     the clinical care of this population.~   "
93143|NCT02347982|"~     This study will compose a national database of cardiovascular diseases' risk factors,~     concomitant diseases and the drug usage among the elderly patients in Turkey.~   "
93144|NCT02347969|"~     The main objective of this trial is to evaluate the effect of the daily dose of X34 dietary~     supplement on skin radiance (clinical assessment) for 8 weeks.~   "
93270|NCT02346318|"~     The randomized controlled multicenter clinical study of compound Kushen Injection to reduce~     the radiotherapy related adverse reactions in lung cancer is a phase Ⅳ clinical trials，The~     main purpose is to evaluate the effect of compound Kushen Injection in preventing and~     reducing the radiotherapy related adverse reactions. The participants of the clinical trials~     are patients with lung cancer who need thoracic radiotherapy. In clinical trials, one group~     of participants is given compound Kushen Injection with chemoradiotherapy, while another~     group is only given chemoradiotherapy. The period of trials is 18 months.~   "
93145|NCT02347956|"~     Gastric cancer is one of the most common malignancy worldwide. Surgical resection of the~     tumor is the only curative treatment for gastric cancer. However, surgical procedure~     accompanies postoperative pain and prolonged hospitalization. To lessen the surgical trauma~     and stress, minimally invasive surgery were introduced. Laparoscopic gastrectomy was accepted~     as safe and effective alternative to open gastrectomy. Furthermore, reduced port and single~     port laparoscopic gastrectomy are considered to minimize the surgical trauma during~     gastrectomy. However, limitations of laparoscopic approach using reduced port includes~     unergonomic posture of surgeon, physiologic tremor and collision of instruments. To overcome~     these limitations, robot surgery using novel single-site technology enabled surgeons to~     perform the surgical procedure reducing the number of trocar from three to one for insertion~     of scope and two robotic arms. Previously, successful application of single-site technology~     for cholecystectomy and hysterectomy were reported. The aim of this study is to validate the~     safety and feasibility of reduced port robotic distal gastrectomy using single-site~     technology for the surgical treatment of gastric cancer.~   "
93146|NCT02347943|"~     This study evaluates long-term safety and effectiveness of primary sinus surgery in a~     real-world population of adults with chronic rhinosinusitis (CRS) or recurrent acute~     rhinosinusitis (RARS). This post-market study will evaluate sinus surgery performed using~     commercially available sinus instrumentation (e.g. sinus balloon catheters, powered~     microdebriders, manual instruments).~   "
93147|NCT02347930|"~     Establish an integrated evaluation system of ultrasound technology for the prognosis of acute~     kidney injury, and in order to achieve non-invasive, reliable early diagnosis gold~     standard. Set up collabration with the expert in National Cheng Kung University Medical~     Center of Taiwan who did a lot of excellent work in basic research of prevention the~     progression of acut kidney injury. Study the experience about prevention progression of~     kidney disease in clinical and basic field. Establish cooperation with the professional in~     Hong Kong University of Science and Technology. To set up the system of natural products~     research and assess the Astragalus medicinal value.~   "
93148|NCT02347917|"~     This is an open-label, multicenter, phase 1/2 study of BBI608 in combination with pemetrexed~     and cisplatin chemotherapy as a 1st line treatment for Malignant Pleural Mesothelioma (MPM).~   "
93149|NCT02347904|"~     In this prospective single arm study the investigators will assess the feasibility of S-1 and~     Oxaliplatin as adjuvant treatment in patients with esophageal cancer.~      The primary objective is to assess the feasibility of administering adjuvant S-1 and~     Oxaliplatin (SOX) in patients with esophageal cancer after neoadjuvant chemoradiotherapy with~     paclitaxel and carboplatin and esophagectomy. Primary end point is the percentage of patients~     completing the preplanned number of 6 cycles of SOX.~   "
93150|NCT02347891|"~     The goal of the trial is to evaluate the efficacy and safety of belimumab as a maintenance~     therapy in adults with refractory Idiopathic inflammatory myositis (IIM) as compared with~     standard of care. This is a multicentre double-blind, placebo-controlled trial.~   "
93151|NCT02347878|"~     Headache following a lumbar puncture （post-lumbar-puncture headache,PLPH）is a common and~     often debilitating syndrome, which was reported to occur in about 40% patients who received~     lumbar puncture. Now there lacks of effective approaches in the prophylaxis of PLPH, although~     some physicians consider bed rest for at least 6 hours to be a useful methods (Some recent~     meta-analysis found no benefit of bed rest for any hours in the prevention of PLPH). Studies~     have found that P substances and its receptor (Neurokinin-1 receptor, NK-1R)have played an~     important role in the pathogenesis of PLPH. Thus, we hypothesize that use of NK-1R inhibitor~     (aprepitant) 1 hour before lumbar puncture may decrease the incidence of PLPH and lower the~     severity of PLPH.~   "
93152|NCT02347865|"~     The purpose of the study is to describe the characteristics and management of post menopausal~     women with osteoporosis treated with Prolia in France, and examine the use of Prolia in~     routine clinical practice in France~   "
93153|NCT02347852|"~     The purpose of this trial is to quantitatively assess the average amount of physical activity~     that patients are capable to perform while receiving regorafenib for the treatment of~     metastatic colorectal cancer. The assessment of this reference value, measured by CE~     (Conformité Européene)-certified pedometer and international physical activity questionnaire,~     will allow an estimation on the feasible amount of physical activity for patients in this~     therapeutic setting.~      This study is available for patients who are included in the global non-interventional study~     CORRELATE (Safety and efficacy of regorafenib in metastatic colorectal cancer patients;~     NCT01843400) in Austria.~   "
93154|NCT02347839|"~     The purpose of this study is to studying neoadjuvant gefitinib followed by surgery, followed~     by adjuvant gefitinib to see how well it works in treating patients with unresectable stage~     III NSCLC harboring EGFR mutations.~   "
93155|NCT02347826|"~     An email questionnaire about subjective satisfaction and discomfort has been sent to 243~     patients undergoing non-surgical facial and cervical lift 1 week, 1 month, 6 months and 1~     year after treatment.~   "
93156|NCT02347813|"~     This study is proposed based on our work showing that the diabetes drug Pioglitazone strongly~     inhibits growth of tissue cultured squamous cell carcinoma (SCC) of the skin. This occurs at~     concentrations readily achievable by oral administration of this drug using doses currently~     approved for the treatment of diabetes. In our study, we propose to enroll 40 non-diabetic~     adult subjects (18-80 yrs of age inclusive) with a documented clinical history of frequent~     occurrence of skin squamous cell cancer to receive Pioglitazone (Actos®,Takeda~     Pharmaceuticals). Each subject will receive usual care for all new tumors they develop while~     on study (i.e, excision and plastic repair). The study protocol will randomize (1:1) patients~     for 6 months of observation followed by 6 months of treatment (group 1) or 6 months of~     treatment with drug followed by observation for 6 months (to examine washout effects). The~     biopsy specimens collected on and off therapy will be examined to determine if they express~     AKR1C3, an enzyme we believe increases resistance of SCC to prostaglandin inflammatory~     mediators. We will also examine the histologic grade of the removed tumors and study whether~     Pioglitazone treatment can decrease the number of aggressive versus well differentiated~     tumors in study patients. This pilot study is designed to detect a statistically significant~     change in SCC tumor numbers but is not sponsored by the drug manufacturer. The data obtained~     will not be used to effect a change in the product label.~   "
93160|NCT02347748|"~     Background: Pre anaesthesia anxiety in children is a strong predictor of postoperative~     behavior challenges and outcomes. In addition, intra-operative stress can precipitate~     post-traumatic stress symptomatology. Comfort Talk, consisting of rapport, relaxation, and~     reframing of potentially stressful experiences, applied pre-operatively in script form, has~     been highly successful in alleviating anxiety and positively affecting procedural outcomes in~     adult patients undergoing interventional procedures. No published literature exists~     evaluating its' impact in paediatric cardiac catheterization. Purpose: To investigate the~     impact of comfort talk on the level of pre-induction anxiety, procedural and recovery~     experience, as well as short-term post-procedural behaviour and satisfaction after discharge~     in pediatric patients undergoing cardiac catheterization procedures. Design: Prospective~     randomized, double blind controlled trial. Participants: 160 children, ages 7-18 years,~     having a cardiac catheterization procedure under general anaesthesia. Intervention: Group A~     will be read a pre-procedure comfort talk script in the pre-procedure work-up area; Group B~     will be read a pre-extubation (before the breathing tube is removed) script ; Group C will be~     read a pre-procedure plus a pre-extubation script; Group D will not be read any script. All~     groups will be treated according to the standard of care approaches usually provided for~     anaesthesia, catheterization, and recovery. Outcomes: We will compare the effect of the~     script strategy on preoperative anxiety. Procedural and recovery measurements will include~     room time in the catheterization suite, time to discharge from the recovery room; drug use,~     vomiting, rebleeds, and cardiorespiratory stability. Postoperative behaviour will be assessed~     by questionnaire. Postoperative anxiety and pain will be secondary outcome measures using~     queries on 0-10 verbal self-report scales Hypotheses are:~        1. Patients being read a preoperative Comfort Talk script will experience less anxiety~          prior to anaesthesia induction.~        2. The reduction of anxiety prior to induction is associated with better immediate and~          short-term recovery outcomes.~        3. Patients being read a pre-extubation script will recover better than controls.~        4. The combination of a pre-procedure script and a pre-extubation script will have the~          greatest positive effect on physical and emotional well-being in the immediate recovery~          period and at short term follow-up.~   "
93161|NCT02347735|"~     Rationale: Colorectal cancer is the fourth most common cause of cancer death worldwide,~     estimated to be responsible for almost 610,000 deaths in 2008. Surgery remains the~     predominant curative treatment type for colorectal cancer, but has a major impact on the~     patient's wellbeing by demanding large amounts of metabolic reserves. This can lead to the~     development of frequently observed and severe postoperative complications. The most important~     complication after colorectal surgery is anastomotic leakage (AL), which has an incidence of~     8-15% in the Netherlands. AL is associated with high short-term mortality rates of up to 40%.~     Even though many attempts have been made to reduce the incidence of this dreaded~     complication, none of these interventions have been successful so far. Despite proper patient~     selection and improvement in surgical techniques, the percentage of AL has been stable for~     years.~      Objectives: To investigate whether recently identified patient-specific factors can predict~     the occurrence of anastomotic leakage in patients undergoing elective surgery for colorectal~     cancer.~      Study design: Prospective observational study Study population: Adult colorectal cancer~     patients undergoing elective surgery. Main study parameters/endpoints: Primary endpoint: AL~     within 30 days postoperatively Secondary endpoints: Intestinal microbiome in fecal sample,~     I-FABP, SM22, Calprotectin, C-reactive protein(CRP), Citrullin, complement factors in blood,~     VOCs in exhaled air, COX-2 & MBL polymorphisms in buccal smear, L3-index & atherosclerosis~     measurements on CT-scans, SNAQ & MUST scores~   "
93162|NCT02347722|"~     The purpose of this study is to evaluate existing biomarkers and see if they can be used to~     accurately diagnose the etiology of heart failure.~   "
93163|NCT02347709|"~     The primary purpose of this study is to determine the degree of loss of epidermal nerve~     fibers near a foot wound in patients with diabetic foot ulcers. The secondary purpose will be~     to determine whether the degree of epidermal nerve fiber loss, the clinical examination,~     nerve conduction studies or the molecular profile correlates with appearance of lower~     extremity ulcers in patients with diabetes.~   "
93164|NCT02347696|"~     This study aims to evaluate the effect of two programs of different intensity level of~     physical activity, of low glycemic index Mediterranean Diet and of the interaction of both,~     on NAFLD score and on the lipid composition of the erythrocyte membrane.~   "
93165|NCT02347683|"~     The optimal timing to measure thyroglobulin(Tg) after thyroidectomy is unknown in patients~     with thyroid cancer. The ATA and NCCN guidelines are not specific on optimal timing of Tg~     levels in post-op state and suggest anywhere between 2-12 weeks.~      Hypothesis - Post -op Tg nadirs at 6-8 weeks .~      Primary Objective -Determine optimal timing of post thyroidectomy Tg nadir, so to determine~     the most accurate time to check post operatively.~      Secondary Outcome - Determine factors that will affect Tg levels post operatively.~      All adults age 19 and above already planning to undergo near total /total thyroidectomy for~     reasons unrelated to the study.~      Measure Tg , Tg Ab and TSH pre-op, post op ---> 7-14 days, 4 wk, 6 wk, and 3 month in~     patients with pathology confirmed benign disease.~      Measure Tg , Tg Ab , TSH pre-op, post op ---> 7-14 days, 4 wk, 6 wk, 3 month, 6 month, and 12~     month in patients with thyroid cancer.~   "
93166|NCT02347670|"~     The project aims to determine the effectiveness of a patient-centered health care delivery~     system focused on improving follow-up adherence in patients diagnosed with glaucoma. Over the~     course of 1 year, a 6-person team comprised of one attending physician; project managers and~     community health educators, ophthalmic technician, and patient navigators will complete a~     baseline visit, baseline assessment and 2-3 follow-up visits. The patient navigator will~     assist participants in community groups and a portion of the office-based participants with~     scheduling follow-up appointments~   "
93167|NCT02347657|"~     This is a Phase 3, randomized, double blind, placebo controlled, parallel group, multicenter~     study in people with CF who are homozygous for the F508del CFTR mutation.~   "
93178|NCT02347514|"~     Community health centers across the US are seeking to address the growing prevalence of~     diabetes in adults. The University of Chicago has partnered with the MidWest Clinicians'~     Network (MWCN) to conduct a research study to train community health center staff and~     providers to implement and sustain diabetes group visits, also referred to as shared medical~     appointments, at their health center. The study's aims are to: 1) Develop, conduct, and~     evaluate a training program for health center staff to implement a diabetes group visit~     intervention in their health center; 2) Assess the implementation of diabetes group visits in~     the community health center setting and determine the cost of implementation; 3) Assess the~     feasibility and cost of implementing a text-messaging intervention in addition to the~     implementation of diabetes group visits in the CHC setting at one health center and 4) Assess~     the impact of the diabetes group visits alone and diabetes group visits plus text-messaging~     on diabetes process measures, patient outcomes, and patient satisfaction compared to control~     patients from the same health center with six months of follow-up once the six-month group~     visit program ends.~   "
93548|NCT02342652|"~     This is a Phase 1, randomised, single-blind, placebo-controlled, 2 stage study design with 2~     multiple dose cohorts of healthy elderly subjects.~      The purpose of the study is to determine the safety, tolerability and pharmacokinetics of~     ASLAN003 in healthy elderly male and female subjects.~   "
93168|NCT02347644|"~     The objective of this study is to explore the efficacy of brief motivational interventions~     (BMIs) for treatment of youth with alcohol and other drug problems after at least 3 months.~     The results of previous studies indicate that brief interventions for unhealthy alcohol use~     have been shown to be effective in primary care settings, with most studies focusing on~     adults and few studies focusing on youth. To date, no BMI studies have been conducted in the~     Ukraine among youth with alcohol or other drug use. Of particular concern are emerging adults~     ages 18-25 who may be at particularly high risk for alcohol problems given historical events~     related to the fall of the Soviet Union and the subsequent economic down turn.~      This study will evaluate the efficacy of BMI by comparing BMI and no BMI conditions among two~     samples of youth screening positive on the prescreen survey for risky drinking. The subject~     pool will come from the Psychoneurological Department: the first location is located in the~     Railway Clinical Hospital, its clinical base, and the second in classes in the department at~     Kiev National Medical University.~      The total sample of 120 will be broken down to 1.) 60 patients from Railway Clinical~     Hospital; and 2.) 60 students from Kiev National Medical University. Participants will be~     stratified by recruitment site and randomized to condition: BMI and control, with follow-up~     assessment at 3 months. In addition to being the first of study to evaluate the efficacy of~     BMI on substance use problems among youth in Ukraine, this study will examine BMI~     intervention processes in relation to alcohol and other drug outcomes. Findings will inform~     research and clinical practice to enhance early identification and prevention of problematic~     alcohol use trajectories among emerging adults~   "
93169|NCT02347631|"~     This is a prospective, single center, randomized, bilateral crossover, dispensing clinical~     trial to evaluate the effects of the water gradient lens, DAILIES TOTAL1, on the biology of~     corneal epithelium over two months of daily wear compared to wear of a control high oxygen~     permeable silicone hydrogel daily disposable contact lens, the ACUVUE TruEye; and to~     correlate these changes with alterations in the lid wiper, tear film and cellular changes at~     the limbus. The total proposed duration of this study is 12 months to ensure enrollment of up~     to 94 established contact lens wearers, with anticipated completion of 84. Data will be~     collected at baseline and following 2 months of daily wear for each lens type. Based upon~     data from the investigators previous contact lens clinical trials, a 1 month washout period~     is required prior to initiating lens wear to eliminate any potential residual solution or~     lens effects on the corneal epithelium and restore homeostasis. The study is scheduled to~     commence upon Institutional Review Board approval.~   "
93170|NCT02347618|"~     The purpose of this study is to determine whether a short-course of stereotactic body~     radiotherapy (SBRT) prior to surgical resection of pancreatic adenocarcinoma is feasible and~     well-tolerated.~   "
93171|NCT02347605|"~     The purpose of this study is to determine if changing the timeframe (relative to cue~     presentation) at which the nicotine lozenge is given can attenuate the increase in symptoms~     of tobacco craving and withdrawal that occur when smokers are presented with smoking cues. In~     this cross-over study, all subjects attend three laboratory sessions at which either nicotine~     lozenge or placebo is given prior to presentation of smoking cues or after presentation of~     smoking cues. The order in which the three conditions will be presented are randomized.~   "
93172|NCT02347592|"~     The straight Tenckhoff is the most common catheter for peritoneal dialysis. A new, more~     expensive,self-locating catheter with a heavy tip has been developed by Di Paolo. The~     investigators used these catheters in parallel for several years. To clarify what catheter~     has least problems the investigators performed a comparative study to clarify if outflow~     problems differed between these catheters.~   "
93173|NCT02347579|"~     Complex Regional Pain syndrome Type I (CRPS-I) is a chronic progressive disease. Patients~     experience dramatic decline of overall well-being, despite the absence of any apparent~     physical cause. The main symptoms are hypersensitivity to pain (hyperalgesia) and~     experiencing normal tactile stimulation as painful (allodynia) in the absence of peripheral~     nerve damage. The debate on the aetiology of CRPS-I is still open.~      The therapy offered to CRPS-I patients is diverse and can involve invasive and non-invasive~     interventions. Current (inter)national guidelines recommend physiotherapy as the best~     non-invasive treatment for rehabilitation. Recently, cognitive and behavioural Graded~     Exposure in Vivo (GEXP) therapy aimed at reducing pain-related fear was found to be effective~     (De Jong et al. 2005), and more effective than standard physical therapy (ReMOVE study,~     articles in preparation). By reducing pain-related fear EXP might reconcile motor output and~     sensory feedback.~      Another type of pain is lower back pain (LBP), which affects 70% to 85% of general~     population, but usually heals within 12 weeks in 90% of patients. The rest of the patients~     suffer from intractable, chronic LBP despite no evident organic abnormality. Research shows~     that also in these patients cognitive and behavioural aspects of pain are important and~     related to physical performance and self-reported disability (Vlaeyen et al., 2000). Several~     studies have demonstrated the success of GEXP in this patient group: GEXP resulted in~     improvements in pain-related fear, catastrophizing, performance of daily relevant activities,~     and in pain intensity (Leeuw et al., 2008).~      This study aims to investigate the effect of GEXP on brain regions involved in the processing~     of harmless tactile stimuli in CRPS-I and CLBP patients, as well as its effect on tactile~     discrimination thresholds. We hypothesize that GEXP will induce 1) an improvement of tactile~     discrimination thresholds, 2) a functional reorganization of primary and secondary~     somatosensory cortex (in regions related to the affected limb in CRPS-I; and to the back in~     LBP), 3) changes in activation of emotional brain circuits during non-noxious stimulation, 4)~     changes in resting state connectivity between emotional and sensory brain areas, 5) changes~     in measures reflecting white matter integrity. No systematic changes are expected in the~     healthy controls.~      Patients diagnosed with CRPS-I and CLBP will participate in a Magnetic Resonance Imaging~     (MRI) experiment. In this observational study, we examine the effects of GEXP treatment that~     all patients receive as part of usual care. Anatomical as well as diffusion-weighted and~     T2*-weighted (Blood oxygenation level dependent) MR images will be acquired. The study has a~     3x4 split plot design with group (CRPS-I patients and CLBP receiving GEXP treatment / healthy~     controls) as between-subjects variable and time (pre-, during, post-treatment and follow-up)~     as within-subject variable.~   "
93174|NCT02347566|"~     Patients with Chronic Obstructive Pulmonary Disease are characterised by a sedentary~     lifestyle. This contributes to increase the number of hospitalizations and mortality.~     Changing this lifestyle is a major objective of the management of these patients. Pulmonary~     rehabilitation helps patients to increase their fitness, but modifying a longstanding~     sedentary habit is more difficult to achieve. This project aims at modifying patients' long~     term physical activity with a physical activity coaching programme. This will help patients~     to transform the benefits of pulmonary rehabilitation into a healthier active lifestyle and~     contribute to reduce hospitalizations, increase quality of life and survival.~   "
93175|NCT02347553|"~     It is known that hypoglycaemia affects various domains of cognitive function. One aspect of~     cognitive function is 'social cognition', which is our ability to interpret facial~     expressions, gestures and speech. It is an approach to understanding human judgement and~     behaviour. There is anecdotal evidence for negative behavioural responses such as~     aggressiveness and argumentativeness during hypoglycaemia and while research has shown that~     hypoglycaemia can cause significant changes in mood, little information exists regarding its~     effect on social cognition. It is therefore not known whether hypoglycaemia affects this~     aspect of cognitive function but, if it did, it could explain why people with low blood sugar~     due to insulin treatment are often resistant to offers of help (for example, they may~     misinterpret a friendly gesture as being threatening). Knowledge of this effect of~     hypoglycaemia can be used to educate relatives and carers of people with diabetes who may~     suffer this problem.~      Hypoglycaemia is also known to have an effect on the electrical rhythm of the heart. This is~     thought to be secondary to adrenaline secretion during hypoglycaemia which provokes a fall in~     the blood level of potassium, a type of electrolyte. Other electrolyte imbalances are known~     to predispose to heart rhythm abnormalities or arrhythmias in other situations and it is not~     known if the levels of these other electrolytes are affected during hypoglycaemia.~      Using specific tests of social cognition and continuous electrocardiographic (ECG)~     monitoring, this study aims to find out whether social cognition is affected by an hour of~     hypoglycaemia and how hypoglycaemia affects blood electrolyte levels and the~     electrophysiology of the heart.~   "
93176|NCT02347540|"~     This study is a cross-sectional case-control study where classical as well as more innovative~     risk factors for CVD will be explored.~      In western countries, more women than men die of cardiovascular disease (CVD), making CVD in~     women an important public health issue. Misdiagnosis of CVD in women is frequently observed,~     posing the clinician for diagnostic and therapeutic dilemmas that can easily result in~     inadequate treatment and worse prognosis. Despite these challenges, CVD in women has been~     underexposed in scientific research.~      Women have gender-specific risk factors like a history of preeclampsia (PE) that contribute~     to their risk for CVD. PE complicates 5-10% of pregnancies, recurs in ~25% and is associated~     with a 2-4 fold increased risk for CVD. Moreover, pre-symptomatic heart failure (HF) stage B~     occurs in 40% of women with a history of PE. HF stage B is thought to precede the development~     of the, mortality related, clinical HF stages C and D (structural heart disease in~     combination with symptomatic disease). Early detection and tailored intervention of women~     with stage B HF decreases progression to the clinical stages and might therefore improve~     clinical outcome and cardiovascular related mortality.~      Phenotypic presentation of HF is currently split up between systolic HF also called HF with~     reduced ejection fraction (HFrEF) and diastolic HF or HF with preserved ejection fraction~     (HFpEF). Women more often have HFpEF in contrast to men. Different pathophysiology and~     disease progression in women compared to men seems to be an important underlying factor. The~     current clinical HF diagnostic tools (e.g. natriuretic hormones and high sensitivity~     troponins) fail to identify early changes that prelude adverse cardiac remodelling and HF,~     and do not discriminate between HFrEF and HFpEF. Moreover, there are sex-related differences~     in biomarker levels for detection of CVD. As a result, clinicians are forced to wait for the~     failing heart to become clinically evident before they can intervene. Therefore, there is an~     urgent need to assess novel biomarkers that could help select high risk women needing further~     follow up and intervention. Biomarkers may not only improve early diagnosis but may also~     unravel disease pathways of HFpEF. Especially when combined with measurements of subclinical,~     surrogate risk markers.~      Objectives~        -  To determine the impact of PE on incidence of macro-and micro-vascular dysfunction~          reflected by surrogate measures for coronary artery disease (CAD) and HFpEF.~        -  To perform a genome wide association study (GWAS) and associate novel biomarker~          expression levels with endothelial function, cardiac diastolic function and IMT~          measurement.~        -  To identify risk factors and surrogate measures for CVD in a) former PE patients without~          HFpEF, b) former PE patients with HFpEF and c) healthy parous controls.~      Study population Cases: women with a history of PE Controls: women with uncomplicated~     pregnancies in the history. Measurements will be performed in clusters at postpartum~     intervals of: ½-2, 5-10, 10-15 and 15-30 years. Number of inclusions will be: 425, 350, 282~     and 233 for each follow-up group respectively.~      Primary endpoints The prevalence of macro- and microvascular dysfunction in former PE~     patients. Novel biomarker detection in former PE patients associated with HF in general and~     HFpEF in particular.~      Secondary endpoints~        -  Lifestyle (questionnaire)~        -  Cognitive ability (questionnaire)~        -  Depression score (questionnaire)~        -  Metabolic syndrome (MetS)~        -  Arterial endothelial function (Flow mediated dilation (FMD))~        -  Intima Media Thickness (IMT)~        -  Glycocalyx thickness (by means of the Glycocheck)~        -  Venous function (plethysmograph)~        -  Electrocardiogram (ECG)~        -  Ergometry~   "
93177|NCT02347527|"~     The overall goals of this project are to determine the impact of an implicit priming~     intervention, designed to alter food perceptions, on both brain responses to food and on food~     intake behaviors in overweight/obese individuals. The investigators hypothesized that this~     bottom-up sensory-level conditioning approach would effectively result in reduced preference~     for high-calorie foods.~   "
93179|NCT02347501|"~     The primary purpose of this study is to determine if sitagliptin (Januvia®) improves~     psoriasis severity after 24 weeks of treatment in 60 participants with psoriasis who do not~     have type 2 diabetes mellitus, and who are due to receive a course of narrowband~     ultraviolet-B phototherapy (NB-UVB). The investigators will compare the change in psoriasis~     severity in 60 participants treated with both sitagliptin and NB-UVB to 60 participants~     treated with NB-UVB alone. Participants will be recruited from two centres and after a 3 week~     run-in period will be followed prospectively for 36 weeks. Participants will be stratified by~     centre, plasma glycated haemoglobin level (HbA1c), obesity status and previous response to~     NB-UVB, after which they will be randomly allocated to Arm A or Arm B. Participants will be~     treated with either sitagliptin for 24 weeks and NB-UVB (Arm A), or NB-UVB alone (Arm B).~      Both the research participants and the investigators will be aware of the trial arm to which~     the research participant has been allocated randomly (open-label study). Research~     participants are prohibited from using systemic psoriasis therapy for the duration of their~     trial involvement.~      Participants will be assessed at 8 study visits over 39 weeks. Participants will complete~     questionnaires, have a medical history recorded and physical examination, blood sampling and~     skin biopsies taken (in a small number of willing participants at 2 visits).~      The following endpoints will be analysed:~      Changes in psoriasis severity at 24 and 36 weeks; changes in validated quality of life~     scores; incidence of adverse events; incidence of discontinuation of one of the study IMPs,~     time to relapse of psoriasis; changes in cardiovascular disease risk factor profiles; changes~     in cytokines, hormones, expression of immune proteins in blood and skin biopsies; and genetic~     profiles that predicts best response to sitagliptin therapy.~      The investigators hypothesize that sitagliptin therapy decreases psoriasis severity.~   "
93180|NCT02347488|"~     This study aims to test the effectiveness of a novel combined endotracheal tube holder and~     bite guard when compared with the current standard of care, tape and an oral airway.~   "
93181|NCT02347475|"~     This study aims to measure the changes induced by packed red blood cell (PRBC) transfusion in~     the superior mesenteric artery (SMA) flow velocity and intestinal oxygenation indices in~     premature neonates. These changes will be measured in relation to feeding, before and after a~     blood transfusion. Overall reduction of intestinal perfusion is a risk factor for necrotizing~     enterocolitis (NEC) - a condition with significant mortality and long term morbidity.~     Identifying specific patterns of flow velocity and tissue oxygenation changes will allow for~     planning, studying and implementing risk avoidance and minimization strategies.~   "
93182|NCT02347462|"~     Bilevel Positive Airway Pressure (BiPAP) is increasingly being reported as an effective and~     safe method of respiratory support for children with severe asthma exacerbations unresponsive~     to standard therapies and with impending respiratory failure. Much of the evidence base~     supporting its use comes from retrospective observational studies, and there is currently a~     lack of data from randomized controlled trials to inform this practice.~      The investigators hypothesize that the use of BiPAP in children with moderate to severe~     asthma exacerbations could reduce the length of hospital stay, need for invasive ventilation,~     and use of intravenous bronchodilators. The investigators aim to test this hypothesis by~     randomizing children attending the Emergency Department with a moderate to severe clinical~     severity score refractory to inhaled bronchodilators to receive either BiPAP in addition to~     standard asthma care, or standard care alone.~   "
93183|NCT02347449|"~     The main goal of this study is to characterize whether the results of the Oncotype DX® assay~     affect the physician's treatment recommendations for the adjuvant treatment of women with~     ER-positive (ER+), early breast cancer (EBC) with 1-3 positive lymph nodes who are potential~     candidates for chemotherapy, but for whom the benefits of chemotherapy may be uncertain.~   "
93184|NCT02347436|"~     The known correlation between benign prostatic hypertrophy (BPH) and hypertension could be~     explained by 3 theoretical pathway models. Whether hypertension causes BPH, BPH causes~     hypertension or the two are caused by a common factor is currently unknown.~      In this study it will be investigated whether hypertension is due to the direct effects of~     infravesical obstruction to urinary outflow in patients with benign prostatic hyperplasia.~     The approach will be blood pressure measurement in patients who will have a resection of the~     prostate.~   "
93185|NCT02347423|"~     The background of the present clinical trial is the overall aim of the World Health~     Organization (WHO) to obtain eradication of polio in the world. As part of this overall plan,~     inactivated polio vaccine (IPV) against poliovirus types 1, 2 and 3, at an affordable price,~     needs to be available in low resource third world countries. The intention of the present~     phase II clinical trial is to determine if reduced dose(s) of IPV-Al SSI are safe in the~     target population and do not decrease the immunogenicity clinically significantly compared to~     full dose IPV Vaccine SSI. The infants will receive three doses of one of the trial vaccines~     according to the WHO Expanded Program on Immunization (EPI) schedule of 6, 10 and 14 weeks of~     age.~      A total of 824 healthy infants will be included in the trial.~   "
93186|NCT02347410|"~     This study evaluates the safety and effectiveness of the Spineology Interbody Fusion System~     (SIFS) in an instrumented interbody lumbar fusion in subjects presenting with symptomatic~     single-level lumbar degenerative disc disease.~   "
93187|NCT02347397|"~     This is a prospective, randomized, multicenter clinical study in elderly Chinese subjects to~     compare the safety and efficacy of the SS Bipolar Head and SL-TWIN Stem with Bipolar Head and~     SL-PLUS Stem in hemiarthroplasty of the hip~   "
93188|NCT02347384|"~     This is a prospective, randomized, multicenter clinical study in Chinese subjects to compare~     the safety and efficacy of the Delta PLUS Femoral Head and SL-TWIN Stem with BIOLOX forte~     ball head and SL-PLUS Stem in total hip arthroplasty~   "
93189|NCT02347371|"~     The purpose of this registry is to determine the long term outcomes of heart transplantations~     performed at the Semmelweis University Heart and Vascular Center. All eventual interventional~     and non-interventional procedures will be accounted for and summarized.~   "
93190|NCT02347358|"~     This study is to test a hypothesis that temporary implantation of JRecanTM blood flow~     recanalisation device within 6.5 hours of symptom onset of acute ischemic stroke due to a~     major intracranial artery occlusion following IV r-tPA can provide a greater rate of early~     successful recanalisation than treatment of IV r-tPA alone.~   "
93238|NCT02346734|"~     The primary objective of this study will be to assess the feasibility and patient acceptance~     of a Home Automated Telemanagement (HAT) system in multiple sclerosis patients.~      Our hypothesis is that home telemanagement will be effective and useful in the rehabilitation~     of multiple sclerosis patients. Specifically, the investigators hypothesize that home~     telemanagement using a daily exercise diary, monitoring of compliance with a tailored~     exercise program and regular assessment of strength and motor functions will: 1. Be feasible~     and acceptable in patients with multiple sclerosis 2. Improve patient compliance with home~     exercise program 3. Increase patient mobility and motor functions 4. Be a feasible and~     effective mechanism for affecting multiple sclerosis patient self-efficacy 5. Improve quality~     of life~   "
93191|NCT02347345|"~     The investigator's hypothesis is that active injectors will show a partial reduction in~     markers of immune activation with HCV therapy whereas non-injectors will show a more~     significant reduction in these markers, and will exhibit levels of immune activation that~     approach that seen in similarly studied healthy volunteers.This is based on observations that~     this group of investigators have made. They have shown that individuals who inject drugs have~     high level of immune activation in blood and tissue. Immune activation or chronic~     inflammation has been associated with accelerated aging, cardiovascular, renal and liver~     disease as well as CNS dysfunction. It remains unclear whether increased levels of immune~     activation are due to non-sterile injection of drugs, chronic infection with Hepatitis C,~     chronic opiate use, or perhaps combinations of all 3. To understand the potential~     contribution of infection with Hepatitis C the investigators will compare levels of immune~     activation pre- and post treatment with an all oral, one pill once daily, interferon sparing~     treatment of HCV in 2 groups of chronically HCV infected patients- one actively injecting~     with drugs and the other free of injection for at least 4 months. Immune activation~     comparisons will also include non-injecting healthy volunteers.~   "
93192|NCT02347332|"~     For patients relapsing after platinum-based therapy, few data are available. The current use~     of cetuximab associated with radiotherapy in localized disease and associated with~     platinum-based chemotherapy in the first-line setting stresses the need for new therapeutic~     options at later stages of SCCHN.Vinca-alkaloids demonstrated activity in SCCHN. Vinflunine~     demonstrated superior antitumour activity to vinorelbine in preclinical animal models. Recent~     preliminary phase I results of the vinflunine plus methotrexate combination in SCCHN, based~     on a clinical review, show encouraging antitumour activity and an acceptable safety profile.~     Therefore the combination of vinflunine and methotrexate appears a promising salvage regimen~     after platinum failure.~      The present study has been designed as a multicenter, randomised phase III study which will~     compare the combination of IV vinflunine with methotrexate to methotrexate alone in SCCHN~     patients having failed platinum-based therapy.~   "
93193|NCT02347319|"~     Purpose~      - To evaluate the efficacy of Biphenyl dimethyl dicarboxylate(DDB)/Garlic Oil in patients~     with elevated transaminase chronic liver disease.~   "
93194|NCT02347306|"~     Cardiovascular disease remains the leading cause of death worldwide. Identifying individual~     patients at risk of a suture adverse events, including myocardial infractions (heart~     attacks), remains a major diagnostic challenge. Recent studies have shown that coronary~     plaques responsible for hear attack are composed of a large lipid core with a thin overlying~     fibrous cap. Although these features can be identified using invasive imaging modalities,~     non-invasive imaging options remain limited due to their poor spatial resolution. Recently~     the investigators have developed and validated a novel tool that will allow us to~     characterise coronary plaque composition based on dual source CT images. Our aim is to assess~     this tool within a cohort of patients who have already undergone a coronary CT as part of a~     previous study.~   "
93195|NCT02347293|"~     The experimental model is a semi-acute, over-night, study where the purpose is to evaluate~     food factors related to colonially derived regulation and satiety in healthy subjects.~   "
93196|NCT02347280|"~     LAY SUMMARY~      Clostridium Difficile (C.difficile) is a bacterial infection that can cause an inflammation~     of the colon, (C.difficile colitis). This sometimes progresses to a sudden and severe~     illness. The present treatment for fulminant colitis is a total abdominal colectomy with end~     ileostomy. This means, a surgery is performed which removes the entire diseased colon. The~     end of the small intestine is then brought out to the front of the abdomen as a stoma, and~     the patient wears a bag. Despite this invasive treatment, there remains a significant rate of~     death (38-50%). In addition, patients have a long recovery after this long operation and many~     (67%) will not be fit for a second big operation to remove the stoma (that is to reconnect~     the intestine).~      The purpose of our study is to determine if a loop ileostomy with colonic lavage will result~     in better outcomes. A loop ileostomy is when a loop of small intestine is brought out to the~     abdomen and the colon remains in the abdomen. The diseased colon, which is preserved, is~     washed with a warm solution (like the solution used in a colonoscopy preparation) and then~     treated with an antibiotic via this ileostomy. So far, one study has been done using a loop~     ileostomy with colonic lavage. 42 patients who underwent this treatment were compared to 42~     patients that underwent the standard of care (complete removal of the colon with end~     ileostomy). The 42 patients who underwent a loop ileostomy showed a significant decrease in~     rate of death compared to the standard of care. Also, in the study, patients who underwent a~     loop ileostomy had a much higher rate of reconnection of the intestine (closing the stoma).~     The purpose of this study is to see if a loop ileostomy with colonic lavage can treat~     patients with fulminant colitis with less risk of death than the standard of care.~      Once the patient is diagnosed with fulminant colitis and meets the eligibility criteria,~     he/she will be asked by the surgeon on-call if they would like to participate in this~     research study. If they agree to be in this study, they must first sign a consent form. They~     may be asked by the surgeon to enroll in either the investigational arm (loop ileostomy) or~     the standard of care arm. After surgery, all patients will receive the same standard routine~     care. During the hospital stay, information will be taken from their chart for purposes of~     the study. Routine follow up visits with their surgeon will be at 2, 3, 6, and 12 months~     after surgery. If the patient decides to be in the study, the patient will be expected to~     complete all the follow up study visits. The patient will not be required to do anything~     extra or have any extra tests if they decide to be in the study at any of these visits.~   "
93197|NCT02347267|"~     The impact of reduction in consumption of caloric and no caloric sweetened beverages on:~        -  weight~        -  body composition~        -  blood pressure~        -  young adults~   "
93198|NCT02347254|"~     The proposed study is to evaluate the safety and initial effectiveness of the ExAblate~     Transcranial MRgFUS) treatment of patients with L-dopa induced dyskinesia of Parkinson's~     disease (LID PD).~      Safety:~      To evaluate the incidence and severity of adverse events associated with ExAblate~     Transcranial 4000 MRgFUS treatment of dyskinesia of Parkinson's disease.~      Effectiveness:~      To determine the level of effectiveness of the ExAblate Transcranial MRgFUS treatment of LID~     in PD patients. Efficacy will be determined utilizing clinical rating scales for dyskinesia~     (UPDRS-IV and the Unified Dyskinesia Rating Scale) from examinations at Baseline, 3-Months~     and 12-Months post-ExAblate treatment.~   "
93199|NCT02347241|"~     The overall objective is to determine whether a bundled In-hospital Newborn Resuscitation~     Edu-cation intervention (INSPIRE-D) improves process of care associated with improved newborn~     survival and neurologic outcomes.~   "
93200|NCT02347228|"~     The objectives of this Phase I study are to determine the maximum tolerable dose (MTD) and to~     evaluate pharmacokinetics (PK), safety/ tolerability and - preliminary efficacy of OB318 in~     patients with advanced solid malignancies.~   "
93201|NCT02347215|"~     Serial assessment of angina status and ischemia on stress echo over one year among patients~     with moderate ischemia on stress imaging and non-obstructive CAD on coronary CT angiography.~   "
93202|NCT02347202|"~     A 20+ year randomized controlled trial (RCT) demonstrated the many benefits of a counseling~     and support intervention for spouse caregivers, the NYU Caregiver Intervention (NYUCI). The~     NYU Caregiver Intervention (NYUCI) is an evidence-based intervention that provides counseling~     and support for families involved in the care of a relative or friend with Alzheimer's~     Disease and Related Dementias (ADRD). Most notably, the NYUCI substantially reduced~     caregiver's depressive symptoms, improved their physical health, and extended the time~     persons with ADRD remained at home by an average of 1.5 years (Mittelman et al., AG14634,~     formerly MH42216; See http://www.ncbi.nlm.nih.gov/pubmed/17101889).~      The intervention is now being widely implemented in-person, but there are barriers that~     prevent many caregivers from receiving its benefits, including geographic distance;~     impediments to older adults leaving their homes; and travel considerations for counselors~     which make it impossible to provide the NYUCI in person.~      The goal of this study is to evaluate the efficacy of an online videoconferencing version of~     the NYUCI. This innovative application has massive implications for social service delivery~     to older adults, because it will make it possible to deliver an in-person intervention, via~     the internet, which is already evidenced based to older adult caregivers who cannot currently~     be served. It will create the online reservation and management technology linking counselors~     with families as well as the evidence of effectiveness of providing such services via secure~     video teleconferencing vehicles. The proposed Telehealth Technology for Distance Counseling~     (TTDC) and related online educational training modules will connect skilled providers to the~     families of persons with dementia without regard to geographic location. Implications for~     rural healthcare delivery are particularly persuasive. To the investigators knowledge, this~     will be the first large-scale TTDC to be developed and rigorously tested with a randomized~     controlled trial. The investigators hypothesize that such a system, coupled with online~     training for providers and families on tele- counseling and distance caregiving, will have~     similar benefits to those achieved with in-person counseling during the original NYUCI RCT.~      This project includes an online reservation and management technology linking counselors with~     families via secure videoconferencing vehicles. The Telehealth Technology for Distance~     Counseling (TTDC), and online technology developed as part of this overall effort, will~     connect skilled providers to the families of persons with dementia without regard to~     geographic location. The related online clinical modules (i.e., interactive, computer-based~     educational materials) developed as a part of this grant effort will prepare counselors to~     provide the intervention, and caregivers to utilize the internet software, to be able to~     participate in counseling.~      The TTDC will include a scheduling system to link counselors to families at their mutual~     convenience and assure delivery in a cost-effective manner. The TTDC has the additional~     potential to transform ADRD care in ethnic and culturally diverse communities by connecting~     highly trained NYUCI counselors with specialized language and cultural skills to families who~     would not have access to these resources locally.~      In this study investigators will have 240 caregivers navigate the online educational module~     and the online reservation system for connecting caregivers with social workers. Half of the~     caregivers will then be paired with social service providers to receive counseling over the~     telephone, and the other half with be paired with social service providers to receive~     counseling via Zoom, a video conferencing program. Recruiting across the United States and~     Toronto, Canada.~   "
93203|NCT02347189|"~     Non-randomized, multi-center, prospective surveillance study to investigate and assess the~     residual risks, and to confirm the currently established safety and performance of the Melody~     TPV PB1016.~   "
93204|NCT02347176|"~     The aim of the study is to evaluate the efficacy and safety of tralokinumab in adults with~     atopic dermatitis~   "
93205|NCT02347163|"~     Recent evidences suggest that zoledronate (zol), one of the most used bisphosphonates (BPs)~     in the clinical setting for the prevention and treatment of bone metastasis in cancer~     patients, may have antitumor activity in early breast cancer in terms of improved disease~     free survival, overall survival and better response in BPs treated patients. BPs are~     mevalonate pathway inhibitors and one of the most intriguing hypothesis supporting their~     anticancer activity relies on the modulation of the mevalonate downstream metabolism.~     Biologically active mevalonate metabolites are involved in tumour cell proliferation and~     invasion and selected cancer subtypes may present a more pronounced mevalonate activity, able~     of maintaining an aggressive phenotype. The mevalonate pathway has deep impact on the~     function of YAP/TAZ, transcriptional regulators of tumour growth, and preclinical evidences~     suggest that BPs are able to interfere with YAP/TAZ expression, via mevalonate pathway. This~     study addresses the clinical role of BPs in triple negative breast cancer (TNBC) patients~     selected by the level of mevalonate pathway regulation, namely the p53 expression. This study~     is a multicenter single-arm, phase II study primarily aimed at assessing the anti-tumor~     activity of pre-operative zol measured through its effect on the Ki67 proliferative~     biomarker, in TNBC patients classified according to the p53 expression (high vs low p53~     expression). Patients with newly diagnosed, untreated, operable TNBC, intended to definitive~     breast surgery and suitable for pre-operative therapy with zoledronate will receive a~     pre-operative, single administration of zol (4mg i.v.), 7 days before definitive breast~     surgery. Ki67 levels will be assessed in tumor samples collected at the time of diagnosis and~     after zoledronate treatment at the time of definitive surgery. The secondary objective of the~     study is to investigate the effect of zoledronate on critical genes/proteins related to p53~     and mevalonate pathways, p53/PIN1 and YAP/TAZ, analyzed in the tumor tissue collected at the~     time of diagnosis and at definitive surgery. Zol safety profile will be evaluated by the~     NCI-CTCAE scale, version 4.0, and by the occurrence of serious adverse reactions. The total~     number of patients required is forty. The overall duration of the project is 32 months (30~     months for accrual, followed by 2 months of follow-up after the recruitment of the last~     patient).~   "
93206|NCT02347150|"~     Several patients die in the intensive care unit (ICU) due to their acute disease and comorbid~     conditions. Moreover, after ICU discharge, some ICU survivors still die in the wards.~      Previous studies have shown that the clinical condition of the patient at the time of ICU~     discharge may influence in-hospital prognosis. Non-modifiable factors, such as age and~     comorbid conditions certainly play a role. But inflammatory status (especially C-reactive~     protein - CRP), Sequential organ failure score (SOFA) score and Therapeutic intervention~     scoring system (TISS) 28 score have also been related with the risk of hospital death.~      Admission to a high dependency unit may reduce the ICU length of stay (LOS). This strategy~     may also help to improve prognosis contributing to further stabilize the patient, facilitate~     his autonomy and the removal of invasive devices. However the benefit of a step-down strategy~     (from ICU to a high dependency unit) has never been evaluated.~      The development of a score to evaluate the risk of patients discharged from the ICU may help~     to improve the allocation of resources, either to prolong the ICU stay, or admission to a~     high dependency units or the ward.~   "
93207|NCT02347137|"~     As the loss of muscle mass with aging is associated with a dysregulation of muscle protein~     synthesis (MPS) that is generally characterized by an 'anabolic resistance' to nutrients, the~     primary outcome of the trial is to investigate the effect of a mixed macronutrient beverage~     on post-prandial myofibrillar MPS. However, the 'anabolic resistance' of aging may be~     predominantly influenced by the contractile activity of skeletal muscle; for example, the~     investigators have demonstrated that 2 weeks of reduced habitual activity (i.e. daily step~     count) induces anabolic resistance in otherwise healthy older adults. In contrast, resistance~     exercise is well-known to enhance muscle mass and can increase the sensitivity of skeletal~     muscle to dietary amino acids. Therefore, all participants will undergo a 2-week reduced step~     count intervention combined with a unilateral leg resistance exercise protocol to induce an~     'unhealthy' or 'anabolically resistant' leg and a relatively 'healthy' or 'anabolically~     sensitive' leg, respectively; this within subject model will be utilized to investigate the~     effect of the mixed macronutrient beverage in both relatively 'healthy' and 'unhealthy' older~     muscle. The investigators will also measure changes in muscle mass, muscle function, and~     cardiovascular health of both legs before and after the 2-week intervention to determine the~     effect of reduced activity and the protective effect of minimal, low-intensity exercise on~     these outcomes.~   "
93208|NCT02347124|"~     The current study will test the effectiveness of a multi-modal behavioral intervention (the~     Oral Health 4 Life program) targeted to smokers who are ready to quit smoking and seeking~     services through tobacco quitlines.~      The investigators hypothesize that, compared to people in the control arm, participants in~     the enhanced intervention will:~        1. Be more likely to quit smoking as evidenced by 7 day point prevalent abstinence rates at~          6 month follow-up [primary outcome] and at 2 month follow-up [secondary outcome].~        2. Be more likely to see a dental care professional in the past 6 months at 6 month~          follow-up [primary outcome].~        3. Exhibit more positive change in relevant oral health knowledge/beliefs and attitudes~          (e.g., self-efficacy, motivation) that could influence future behavior change.~   "
93209|NCT02347111|"~     In this pilot and feasibility study, the investigators will enroll patients with frequent~     symptomatic episodes of atrial fibrillation (AF) in a cross-over study testing two different~     classes of anti arrhythmic drugs (AADs). This pilot and feasibility study will provide~     preliminary data for a larger study in which the investigators will test the hypothesis that~     a common AF genetic risk allele modulates response to different AADs.~   "
93210|NCT02347098|"~     The purpose of this randomized, multi-site, clinical trial is to determine whether intensive~     therapy consisting of cholesterol-lowering statin drugs plus apheresis to cleanse the blood~     of low-density lipoprotein (LDL) cholesterol is more effective than statin therapy alone in~     reducing plaque volume in heart arteries of patients who have already suffered an acute~     coronary syndrome (ACS). The study will also investigate whether this intensive approach can~     help increase the presence of endothelial progenitor cells (EPC), stem cells that have been~     shown to reduce CV events in ACS patients. This study has two phases and FDA approval for~     phase II has been received and all information has been updated to reflect PREMIER Phase II.~   "
93211|NCT02347085|"~     Randomized, Phase IIIb, Two-period, Two-treatment Double-blind, Multi-center, Crossover Study~     to Evaluate the 24-hour Lung Function Profile in Subjects with Moderate to Very Severe COPD~     after 4 Weeks of Treatment with PT003 and Placebo MDI~   "
93212|NCT02347072|"~     Randomized, Phase IIIb, Three-period, Three-treatment, Double-blind, Multi-center, Crossover~     Study to Evaluate the 24-hour Lung Function Profile in Subjects with Moderate to Very Severe~     COPD after 4 Weeks of Treatment with PT003, Open-Label Spiriva® Respimat® (Tiotropium~     Bromide) as an Active Control, and Placebo.~   "
93239|NCT02346721|"~     The primary objectives of this study are to evaluate the efficacy, safety, and tolerability~     of treatment with sofosbuvir/velpatasvir (SOF/VEL) in participants with chronic genotype 1,~     2, 4, 6 or indeterminate HCV infection who received placebo in the Gilead-sponsored study~     GS-US-342-1138.~   "
93213|NCT02347059|"~     Deep Brain Stimulation (DBS) of the Subthalamic nucleus (STN) is an established treatment for~     patients with advanced Parkinson's disease (PD). STN DBS improves dopaminergic~     drug-responsive motor symptoms, thus allowing a reduction of post-operative drug dose.~     However, a considerable variation in the extent of dopaminergic drug reduction has been~     reported, with values ranging from 20% to 100%. Both L-dopa and DAs can be used, however,~     there are no formal studies examining which type of antiparkinsonian medication may be more~     effective and/or better tolerated following STN DBS.~      Aim of our study is to compare the efficacy and the tolerability of L-dopa monotherapy versus~     DAs monotherapy after STN DBS over a 3-month follow up period.~      This study is a prospective, single blind parallel trial comparing L-dopa monotherapy and DAs~     monotherapy after STN DBS. Patients will be enrolled in pairs, with one patient randomly~     assigned to L-dopa monotherapy and the other to DA monotherapy after STN DBS (20 patients for~     each study arm). Treatment assignment will be unmasked for the patient but will be blinded~     for the neurologist programming DBS and evaluating the patient. Another neurologist will be~     in charge of medication adjustments. Primary outcome is the change in severity of non-motor~     symptoms as assessed by the Non-motor Symptoms Scale (NMSS) at 3-month follow up visit after~     surgery.~      In spite of an improvement of the motor condition many patients develop apathy and depression~     following surgery (Neurosurgery in Parkinson's disease: the doctor is happy, the patient~     less so). This study will shed light on the best way to manage patients after STN procedure,~     thus contributing to a further improvement of the surgical outcome in a population of young~     and motivated patients (those commonly receiving STN DBS), eventually bringing them closer to~     a normal personal and social life.~      Results of our study may provide new insights in the management of advanced PD after STN DBS,~     further leading to development of future larger trials.~   "
93214|NCT02347046|"~     The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety~     after single oral administration of FYU-981 to subjects with renal insufficiency and with~     normal renal function.~   "
93215|NCT02347033|"~     Generalised Anxiety Disorder (GAD) is common, causes unpleasant symptoms and impairs people's~     functioning. It is often chronic and may be accompanied by depression and other anxiety~     disorders. It is not currently clear whether medication or psychological therapy provides~     better long term outcomes for those not responding to simpler low intensity treatments so we~     propose to compare the clinical effectiveness of a pharmacological treatment (the drug~     Sertraline) with a Cognitive Behavioural Therapy (CBT) intervention.~      Our hypothesis is that in people with GAD who have not responded to low intensity~     psychological interventions, CBT will lead to a greater improvement in their GAD symptoms as~     measured using the GAD-7 scale at 12 month follow-up than Sertraline.~   "
93216|NCT02347020|"~     This study will test the hypothesis that a late sleep (Ls) and/or late meal (Lm) behavioral~     pattern, with equal sleep duration, will promote positive energy balance and insulin~     resistance (IR).~   "
93217|NCT02347007|"~     The purpose of this study is to determine whether introducing almonds into the diet of~     overweight and obese Blacks and Hispanics improves body composition, decreases liver fat, and~     lowers cardiovascular disease profile.~   "
93218|NCT02346994|"~     The purpose of this study is to compare the effects of a cooking oil on metabolic rate,~     appetite, and metabolic risk markers.~   "
93219|NCT02346981|"~     The purpose of the present study was to analyze the effect of 12 weeks of resistance training~     on post-exercise blood pressure (BP) and to to correlate the acute and chronic decrease in~     blood pressure (BP) following resistance training in normotensive older women. Twenty-eight~     older women were randomly assigned to a training group (TG) or to a control group (CG). The~     TG underwent a resistance training program (8 exercises, 2 sets, 10-15 repetitions), while~     the CG performed stretching exercises (2 sets, 20 s each, 2 nonconsecutive days/week). Both~     groups performed the intervention for 12 weeks. At baseline and after intervention the~     subjects were submitted to two sessions: resistance exercise session and control session. In~     these sessions, BP was obtained in pre and post-sessions. Rest blood pressure were also~     measure at baseline and after 12 weeks of intervention.~   "
93220|NCT02346968|"~     Established markers of kidney function, such as creatinine, have considerable limitations in~     the diagnosis of delayed graft function (DGF) after kidney transplantation (KT). Indeed,~     creatinine does not accurately reflect minor changes of renal function as its levels change~     only upon significant fluctuations of the latter. CAF22 is a molecule which arises from the~     degradation of a larger protein and it is proposed to be a reliable and more sensitive marker~     of renal function. This study aims to further clarify this issue by measuring blood and urine~     concentrations of CAF22 and comparing them with creatinine levels before and after KT.~      The main assumption is that blood CAF22 levels could serve as a more sensitive kidney~     function biomarker than creatinine post-KT to detect DGF.~   "
93221|NCT02346955|"~     The purpose of this study is to evaluate the safety and tolerability of humanized IgG4~     (kappa) isotype monoclonal antibody against CEACAM1 (CM-24 [MK-6018]), administered~     intravenously as monotherapy and in combination with Pembrolizumab (MK-3475), in participants~     with selected advanced or recurrent malignancies. Escalating multiple doses will be evaluated~     to determine the recommended dose for Phase 2 clinical studies.~   "
93222|NCT02346942|"~     The Primary objective of this study is to understand the rheumatoid arthritis (RA) population~     in national integrated delivery network who are treated with first- or second-line biologic~     disease modifying anti-rheumatic drug (bDMARD) therapy (with or without Methotrexate) and to~     evaluate switching patterns and reasons for switching to another bDMARD.~   "
93223|NCT02346929|"~     The purpose of this study is to determine the efficacy of ultrasound guided hematoma block~     versus traditional blind hematoma block for analgesia in distal radius fracture reduction.~   "
93224|NCT02346916|"~     The purpose of this study is to determine whether there is a positive correlation between the~     ability to sense chest pain in the context of myocardial ischemia and the ability to sense~     discomfort associated with the topical application of the TRPV1 agonist capsaicin (the active~     ingredient on hot chili peppers).~   "
93240|NCT02346708|"~     This study plans to learn more about the brain function related to thinking problems in~     individuals with Parkinson's disease.~   "
93241|NCT02346695|"~     Impaired myocardial deformation may determine cardiac diastolic dysfunction. The~     investigators will investigate the vascular determinants of myocardial deformation and~     twisting-untwisting and their interrelation with exercise capacity in patients with untreated~     arterial hypertension~   "
93329|NCT02345538|"~     The purpose of this study is to establish the range of pelvic floor pressure in groups of~     women, including women with and without pelvic pain, and compare the change in perineometer~     measurements between rest and maximum pelvic floor contraction in women with and without~     pelvic pain. Purpose is also to determine whether resting pelvic floor perineometer~     measurements correlate with the severity of pain symptoms in women with chronic pelvic pain.~   "
93225|NCT02346903|"~     The purpose of this study is to determine whether there is a positive correlation between the~     ability to sense chest pain in the context of myocardial ischemia and the ability to sense~     discomfort associated with the topical application of the TRPV1 agonist capsaicin (the active~     ingredient on hot chili peppers). Patients undergoing clinical elective balloon angioplasty~     of a coronary stenosis will be asked to quantify the subjective intensity of any chest pain~     they feel during a standardized episode of myocardial ischemia produced by a one-minute~     coronary balloon occlusion, using a previously-validated numeric rating scale. The same~     patients will subsequently be asked to grade the subjective intensity of cutaneous discomfort~     resulting from application of a capsaicin-containing patch (Capzasin-HP Cream, an~     over-the-counter product approved for topical application to treat muscle and joint aches) to~     the forearm. The goal will be to determine whether an association can be demonstrated between~     the subjective perception of ischemic chest pain during coronary balloon occlusion and~     cutaneous capsaicin sensitivity. Such an association could have considerable clinical value,~     as it might allow physicians to prospectively assess an individual's ability to perceive~     myocardial ischemia/infarction by assessing his/her subjective response to the topical~     application of capsaicin.~   "
93226|NCT02346890|"~     The study is designed to evaluate safety, tolerability, pharmacodynamics and pharmacokinetics~     of AZD1722 in healthy volunteers taking Renvela.~   "
93227|NCT02346877|"~     This study will evaluate whether the effect of personalized patient counselling tool,~     Information-Motivation-Strategy (IMS) based on the results of the Beliefs about Medicines~     Questionnaire (BMQ) will improve persistence of Enbrel (etanercept) therapy at week 52 in~     subjects with rheumatoid arthritis over the historical control as estimated by the standard~     of care.~   "
93228|NCT02346864|"~     The purpose of this study is evaluating the effectiveness of three-stair-position (TSP) on~     the rate of Apnea of Prematurity (AOP), the feeding performance and the vital signs.~   "
93229|NCT02346851|"~     Post stroke hemiplegia patient have shoulder subluxation in affected side. The investigators~     use functional electrical stimulation in posterior deltoid and supraspinatus for prevention~     and treatment. But the investigators hypothesis self triggered myoelectric stimulation system~     has more effective for shoulder subluxation. The purpose of this study is to compare~     post-stroke shoulder subluxation treatment FES and triggered FES.~   "
93230|NCT02346838|"~     Forty-eight prediabetic men and women (50-75 years of age) will participate in a 6-week~     feeding study in which they will randomized to receive either 10 g/day of inulin or placebo.~     All subjects will be fed an isocaloric diet (50% carbohydrate, 35% fat, 15% protein,)~     controlled for micronutrient content for 6 weeks to avoid the potential confound of~     individual differences in diet on gut microbiota. Measurements of intestinal permeability,~     insulin sensitivity, and skeletal muscle metabolic flexibility will be made prior to and~     following the controlled feeding period. Stool samples will be collected to assess gut~     microbial communities.~   "
93231|NCT02346825|"~     The Baby CHAMP Study is a multisite clinical trial funded by the National Institutes of~     Health that is examining the the use of constraint-induced movement therapy (CIMT) for~     infants and toddlers as a effective treatment, since there have been no randomized control~     trials (RCT) for the age range as well as monitor the stress levels as related by self-report~     of parents or biological indicators. Infants and toddlers who meet study eligibility~     requirements at one of the three clinical sites (Charlottesville, VA, Columbus, OH, and~     Roanoke, VA) will be invited to enroll, and their parents will be provided all necessary~     paperwork along with informational documentation.~   "
93232|NCT02346812|"~     Healthy individuals (n=18) will participate in 2 controlled-feeding study periods that are 3~     weeks each in length: 1) Control diet 2) Brassica diet. The control diet will consist of~     typical American foods and will be free of Brassica vegetables and free of glucosinolates and~     isothiocyanates. The Brassica diet will contain the control diet plus~     glucosinolate/isothiocyanate treatment foods. There will be a break of 3 weeks in between~     study periods. Blood, urine, and fecal samples will be collected at the end of each study~     period. Eligible participants will be selected based on genotype for glutathione~     S-transferase (GST), which has been shown to influence the potential protective role of~     dietary Brassicas. Half the participants (n=9) will be GSTM1-positive individuals and half~     (n=9) will have the GSTM1-null genotype.~   "
93233|NCT02346799|"~     The purpose of this study is to determine whether healthy habits can be formed more~     effectively when people are rewarded for repeated engagement in a given healthy behavior at a~     specific, routinized time each day rather than at any time.~   "
93234|NCT02346786|"~     sports accidents and incidents are relatively frequent. We hypothesize that the pursuit of~     good hydration, including days without training or competition could prevent their occurrence~   "
93235|NCT02346773|"~     Currently, there is considerable interest in the possibility that dietary supplementation~     with fatty acids, mostly omega-3 fatty acids, will have potential benefits for brain~     development. Epidemiological and clinical studies support the idea that relative~     disappearance of omega-3 diet from the diet in developed countries has been linked with~     increases in both physical and mental disorders. Omega-3 deficiency may lead to cognitive~     impairment, motor dysfunction and visual acuity problems. It is further known that families~     with lower socioeconomic status may have poorer diet and, consequently, may not realize their~     full potential regarding their cognitive abilities. The aim of this project is to evaluate~     effectiveness of a diet intervention rich in omega-3 acid in healthy children 9-to-12 years~     old from less well-off families.~   "
93236|NCT02346760|"~     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of a~     single subcutaneous dose of UB-621 in healthy volunteers.~   "
93237|NCT02346747|"~     This is a multicenter, randomized, double-blind, placebo-controlled, Phase 2 study of~     maintenance Vigil Ovarian (gemogenovatucel-T) in women with Stages IIIb, IIIc or IV~     high-grade papillary serous/clear cell/endometrioid ovarian, fallopian tube or primary~     peritoneal cancer. Subjects will have had a minimum of 4 and a maximum of 12 doses of Vigil~     prepared and stored from ovarian tumor cells obtained at the time of primary surgical~     debulking or initial diagnostic/evaluative laparoscopy (tissue for immunotherapy manufacture~     must be procured prior to initiation of neoadjuvant chemotherapy). An equal number of placebo~     doses will manufactured. Subjects will have achieved a clinically defined complete response~     following primary surgery and adjuvant chemotherapy.~   "
93242|NCT02346682|"~     There is heterogeneity in patients with depression. Many scholars propose that~     individualization of antidepressant achieves better outcomes. However, the scientific~     theoretical basis of individualized treatment is still quite weak. Different clinical~     subtypes of depression and their possible biomarkers are critically needed to provide the~     individualization with theoretical base. Diagnostic types of major depression disorder (MDD)~     based on the Theory of Traditional Chinese Medicine (TCM) and possible differentiations in~     neurobiochemistry, metabonomics and neuroimaging could be one of ways to explore the~     biomarkers and support the theory of the individualized treatment.~      The hypothesized results will be of help to clarify the biological basis of MDD with LDQS and~     with DBHS, to provide the TCM with further scientific evidence, to explore the pathogenesis~     of depression, to improve the objective diagnosis of depression, and to promote targeted~     interventions by Western medicine, TCM or both.~   "
93243|NCT02346669|"~     The incidence of obesity has dramatically increased during the last three decades, leading to~     a significant increase of obesity-related morbidity, including type 2 diabetes mellitus~     (T2DM) that is characterized by resistance of target tissues to insulin action. T2DM obese~     patients may be treated by medications or by bariatric surgery. Both alternatives have~     limitations due to incomplete resolution of the diseases, high cost or potential procedural~     related morbidity. An increasing body of evidence points to a role of the enteric microbiota~     in the pathogenesis of obesity-related insulin resistance. In addition to that, the gut~     microbiota is directly affected by the diet composition. Studies in T2DM mice carrying human~     gut germs, demonstrated special interactions between the gut microbiota and the host,~     creating a typical microbiota composition which changes significantly following diet change~     from a western diet, rich with sugar, to a vegetarian diet rich with fibers. This rapid~     alternations in the microbiota composition has also shown in humans, after changing from~     western to high fiber diet. A change in diet life style may lead to an improvement in T2DM~     symptoms such as decrease in visceral adipose tissue.~   "
93244|NCT02346656|"~     15-SMI-2013 is a post market, observational, questionnaire based study to assess the~     effectiveness of the commercially available Axium neurostimulator in the management of~     chronic post surgical groin pain~   "
93245|NCT02346643|"~     11-SMI-2013 is a post market, observational, questionnaire based study to assess the~     effectiveness of the commercially available Axium neurostimulator in the management of~     intractable, chronic pain~   "
93246|NCT02346630|"~     Stroke is the leading cause of acquired long-term disability in adults in developed~     countries. Despite aggressive rehabilitation, lasting upper extremity impairment remains in~     the majority of stroke survivors. It is hypothesized that enhancing neuroplasticity through~     the combination of drug therapy and physical therapy could enhance outcomes for stroke~     survivors. The combination of levodopa and intensive physical therapy shows promise in~     enhancing the functional motor recovery of stroke patients during the sub-acute and chronic~     period without reported significant side effects. Robotic-aided training is a promising tool~     that has the potential to deliver high-intensity, task-oriented, reproducible therapy that~     can decrease the burden on a therapist. Since the evidence behind dopaminergic potentiation~     of neuroplasticity and stroke recovery is promising, it is the investigators aim to combine~     dopaminergic drug therapy with highly intensive robotic-assisted therapy to provide superior~     upper extremity functional recovery over traditional stroke rehabilitation.~   "
93247|NCT02346617|"~     To evaluate the safety and efficacy for treatment of persistent CMV infection in~     hematopoietic cell transplant (HCT) recipients.~   "
93248|NCT02346604|"~     People with mild chronic obstructive pulmonary disease (COPD) can have significant~     physiological abnormalities and breathing inefficiency which become more pronounced during~     the stress of exercise, leading to intolerable breathing discomfort (dyspnea). To better~     understand the mechanisms of respiratory symptoms and exercise limitation in mild COPD, we~     will examine detailed lung function tests and other important measurements during rest and~     exercise in people with mild COPD compared with healthy non-smokers. This will be the first~     study to uncover the fundamental causes of breathing inefficiency and the related shortness~     of breath during physical exertion in patients with mild COPD. We hope to demonstrate that~     one simple measurement during exercise [the relation (ratio) between the total amount of air~     breathed (ventilation) and the amount of carbon dioxide breathed out] gives meaningful~     information about the extent of damage to the small airways and blood vessels in mild COPD~     and the overall gas exchanging function of the lungs, without the need for an arterial blood~     sample.~      This is a case-controlled observational study not involving an intervention. Participants~     will complete 2 visits approximately 1 week apart, each conducted at the same time of day.~     Visit 1 will consiste of screening for iligibility, symptom and activity assessments,~     pulmonary function tests and an incremental cycle cardiopulmonary exercise test (CPET) for~     familiarization purposes. Visit 2 will include spirometry followed by an incremental cycle~     CPET with detailed measures of ventilatory, gas exchange, sensory-perceptual and arterial~     blood gas responses.~   "
93249|NCT02346591|"~     The investigators developed a responsive mobile-web app, Jauntly, which was designed to~     take advantage of the known connections between positive emotions, stress reduction and~     stress resilience. The app's goal was to lead users through research-proven positive~     emotion-enhancing exercises and relevant educational materials. Intervention activities~     covered five well-being-generating content areas: 1) promoting the experience and recognition~     of gratitude; 2) encouraging positive social relationships and feelings of social support; 3)~     improving stress resilience via mindfulness and other relaxation-focused activities; 4)~     focusing and capitalizing on individual strengths (as opposed to limitations and weaknesses);~     and 5) general positive mood inducing activities. Program content was adapted from a variety~     of stress-relevant research areas including health psychology/psychosomatic medicine,~     social/personality psychology, positive psychology, and clinical psychology.~   "
93250|NCT02346578|"~     The objective of this study is to compare the efficacy and safety of enzalutamide or~     alternative AA therapy in CRPC participants who were previously treated with a combined~     androgen blockade therapy which included bicalutamide (Bic-CAB). Efficacy and safety of~     enzalutamide and alternative AA therapy will be evaluated, and effective therapy against CRPC~     after treatment with Bic-CAB will be investigated.~   "
93251|NCT02346565|"~     The overall question the investigators would like to help answer is whether SE with or~     without MCE data can be widely used as a first line investigation in women with no previous~     history of Coronary Artery Disease (CAD) who present with chest pain of recent onset. In~     order to answer this question the investigators will look at the following:~      i) Is SE superior to ExECG in terms of cost to diagnosis and negative predictive value of~     CAD?~      ii) What is the additive value of myocardial perfusion data to wall motion data for~     predicting significant CAD on angiography and future cardiac events in women?~      iii) What is the additive value of Carotid ultrasonography in a large population of women~     referred for stress testing?~   "
93252|NCT02346552|"~     The main objectives of this study are to evaluate the ease of use and performance of the~     AutoLap system compared to human camera holder during general and bariatric laparoscopic~     surgeries.~   "
93253|NCT02346539|"~     The investigators will determine whether an acute dose of nicotine, in the form of the~     nicotine lozenge, impacts brain and behavioral measures of mood and reward responsiveness in~     individuals with major depressive disorder.~   "
93254|NCT02346526|"~     The purpose of this study is to look for markers of how Ra-223 improves the lives of men with~     prostate cancer. This study makes use of Ra-223 in the standard FDA-approved way, but adds~     non-standard testing in an attempt to gain insight about how the drug works and how best to~     track patients who are receiving the drug.~   "
93255|NCT02346513|"~     Primary objectives:~        1. To measure serum metal ion levels (blood Chromium (Cr) and Cobalt (Co) ion~          concentration) in patients that received the Ceramic on Metal arthroplasty of hip and~          who have well functioning primary total hip arthroplasties during short and medium- term~          follow up time points.~        2. To compare blood ion levels of patient that received COM arthroplasty with the blood ion~          levels of patient receiving non-COM standard total hip arthroplasty (a Metal on~          polyethylene or ceramic on polyethylene total hip arthroplasty) at short- term and~          medium-term follow up time points .~      Secondary Objective:~      1) To determine whether these blood levels correlate with any device specific factors such~     as: component position, size and type, wear rate and/or patient specific factors such as~     gender, body mass index, age and activity level.~   "
93256|NCT02346500|"~     Benign prostatic hyperplasia (BPH) is a major cause of lower urinary tract symptoms (LUTS)~     affecting aging men. Medical therapy for BPH includes alpha adrenergic blockers and~     5α-reductase inhibitors. In men with moderate-severe LUTS due to BPH, surgical therapy should~     be considered for 1) those who failed medical therapy and/or 2) those with refractory urinary~     retention, renal insufficiency secondary to BPH, recurrent urinary tract infections (UTI's),~     or bladder stones. The gold standard for the surgical therapy of BPH has been transurethral~     resection of the prostate (TURP). However, TURP is associated with significant comorbidities~     such as bleeding, prolonged catheterization, and absorptional hyponatremia. To minimize these~     problems associate with TURP, alternative minimally invasive treatment techniques have been~     developed. Two of the most commonly used treatment modalities include a photoselective laser~     vaporization of the prostate (GreenLight PVP) using the potassium titanyl phosphate (KTP)~     laser and holmium laser enucleation of prostate (HoLEP). The major problem in all these~     minimally invasive treatment modalities is that they are generally associated with a higher~     retreatment rate. In addition, there is no intraoperative and objective measurement, other~     than a limited, transurethral visualization of the prostatic cavity, to assess the extent of~     the vaporization or enucleation.~      We propose to use the transrectal ultrasound (TRUS) and a novel robot, the TRUS robot, to~     hold and manipulate the TRUS probe to monitor the extent of the vaporization or enucleation~     of the prostate gland intraoperatively. TRUS has been extensively used for the biopsy needle~     guidance during prostate biopsy. However, it has never been used during transurethral~     prostate procedure. The TRUS Robot has been used safely in the current clinical trial,~     NA_00027540, Ultrasound-Guided Navigation in Robot-Assisted Laparoscopic Radical~     Prostatectomy. We would like to study the feasibility and safety of using TRUS and the TRUS~     Robot to monitor the minimally invasive treatment of BPH, such as GreenLight PVP.~   "
93257|NCT02346487|"~     The study will be carried out to provide supportive clinical data on the feasibility,~     efficacy, safety, and PK of LPV based therapies in routine treatment setting and will be~     based on the existing LPV/r pellets which already represent a clear advantage in comparison~     with the liquid formulation.~   "
93258|NCT02346474|"~     Background:~      - It is important for doctors to know how much fat a person has in his or her body. Machines~     called DXAs measure how much fat mass and fat-free mass a person has. Researchers in this~     study have a new DXA machine, and they want to know if it measures body fat as well as the~     old machine. They also want to see how body fat readings from the new DXA compare to readings~     from a magnetic resonance imaging (MRI) scan.~      Objectives:~      - To see if two DXA machines give the same results when measuring body fat. Also, to know~     whether the DXA and MRI give the same results in measuring visceral and subcutaneous fat.~      Eligibility:~      - People 18 years and older who weigh less than 350 pounds.~      Design:~        -  Participants will be screened with a medical history and physical exam. Women will have~          a pregnancy test. Researchers will make sure participants are able to have an MRI if~          they volunteered to.~        -  Participants will have their body fat measured by each DXA scanner. They will lie~          quietly on a padded table while being scanned. The scan uses X-rays to take pictures of~          the body. Both scans will be done on the same morning and will take 10-15 minutes on~          both machines.~        -  Some participants also will have their body fat measured with MRI. They will lie in a~          long, tube-shaped scanner. The machine uses strong magnetic fields and radio waves to~          take pictures of internal organs. Participants will sign an additional consent form for~          this procedure.~   "
93259|NCT02346461|"~     Background:~      - People with GNE myopathy have muscle weakness and can have difficulty walking . The disease~     comes from a gene mutation related to the production of a sugar called sialic acid.~     Researchers think decreased sialic acid may cause the muscle problems. Researchers are~     testing the drug ManNAc which is a building block of sialic acid. It is a powder that is~     dissolved in water.~      Objective:~      - To evaluate the safety of 90 days of ManNAc given by mouth.~      Eligibility:~      - Adults ages 18 60 diagnosed with GNE myopathy.~      Design:~        -  Eligible participants will be admitted to the NIH Clinical Center for the first visit~          and will stay 10 14 days. Participants will have:~        -  Medical history and physical exam~        -  Electrocardiogram to measure heart function~        -  Blood and urine tests~        -  Muscle strength tests~        -  Magnetic resonance imaging (MRI) muscle scans. Participants will lie on a table that~          slides in and out of a metal tube that takes pictures~        -  Questionnaires~        -  Muscle biopsies. Samples of muscle will be taken, one each from the arm and leg.~        -  The study drug as a liquid twice a day~        -  Participants may wear a small activity monitor throughout the study. It can be worn on a~          waistband.~        -  After discharge from the initial visit, participants will take the study drug at home.~          Participants will need to record if they miss any doses.~        -  Visit 2 will be at 6 weeks for 1 2 days of medical evaluation. Blood samples will be~          drawn.~        -  Visit 3 will be at the end of the study. Participants will stay in the NIH Clinical~          Center for 5 6 days for medical evaluations, muscle tests, and scans. Another muscle~          biopsy will be taken. Blood samples will be drawn.~        -  Participants will be contacted by telephone or email about 4 times after leaving the~          clinic.~   "
93330|NCT02345525|"~     The aim of this study is to evaluate the feasibility of a Home-based Constraint-Induced~     Movement Therapy (hCIMT) compared to a Modified Constraint-Induced Movement Therapy (mCIMT)~     delivered in a outpatient setting on upper limb motor recovery in stroke survivors.~   "
93260|NCT02346448|"~     One of the major elements of successful endoscopic retrograde cholangiopancreatography (~     ERCP) is the timely and uncomplicated cannulation of the common bile duct (CBD) . Various~     factors may adversely affect the cannulation procedure of the CBD leading to complications~     (acute pancreatitis after ERCP, perforation of the duodenum , bleeding ). Endoscopic~     sphincterotomy is frequently required for interventional procedures (eg stone extraction).~     During sphincterotomy, incision of the orifice of the papilla will be performed by using a~     sphincterotome. Complications due to sphincterotomy are known: Bleeding, increased rates of~     acute pancreatitis, small bowel perforation and scarring with consecutive stenosis of the~     papilla. As an alternative to sphincterotomy, balloon dilatation using balloon catheters can~     be performed. As a result, bleeding complications and scarring as late effects might be~     prevented. Current data is limited in terms of the risk of acute pancreatitis after ERCP when~     using a balloon catheter.~      This study aims to evaluate the incidence of acute pancreatitis and other complications after~     ERCP. Balloon dilatation of the papilla will be prospectively compared with endoscopic~     sphincterotomy in a randomized multicenter setting.~   "
93261|NCT02346435|"~     Retrospective studies indicate that active surveillance for clinically localized, small renal~     masses (cT1a, <=4cm) is safe. It is our hypothesis that active surveillance is safe and~     efficacious when compared prospectively to patients undergoing immediate intervention for~     their small renal mass.~   "
93262|NCT02346422|"~     The purpose of this trial is to characterize the safety profile and preliminary activity of~     high-dose MYDICAR® in persons with advanced heart failure when added to their maximal and~     optimized therapy.~   "
93263|NCT02346409|"~     Essential tremor (ET) is a frequent and disabling disorder with progressive worsening of~     postural tremor of the upper limbs that impairs most of the manual activities of every day~     life (feeding, drinking, etc.). Although the pathophysiology of essential tremor (ET) is not~     fully elucidated, tremor is associated with abnormal activity within different brain regions,~     in particular the thalamus and the cerebellum. Deep brain stimulation (DBS) of the ventral~     intermediate nucleus of the thalamus (VIM-Thal) reverses the symptoms of tremor but is an~     invasive procedure. Transcranial stimulation of the cerebellum may represent a non-invasive~     therapeutic option for ET patients. Here, the investigators propose to test the efficacy of~     cerebellar stimulation in 15 ET patients previously operated for DBS of the thalamus. To~     further understand how this treatment provokes tremor reduction, the investigators will~     analyse the brain neuronal activity in 13 others ET patients candidate to thalamic DBS by~     using combined electrophysiological recordings of the thalamus (with the electrodes~     implanted), the cerebellum and the cortex with magnetoencephalography.~   "
93264|NCT02346396|"~     The purpose of this study is to confirm the analgesic effect of tDCS in neuropathic chronic~     pain, to estimate the importance and the duration of this effect, and to improve its~     efficiency by the use at home.~      It is established that the repetition of the sessions of cortical stimulation over a week~     improves their analgesic efficacy. However, this effect does not exceed a few weeks and is~     much lower than that of the stimulation implanted surgically. Implanted stimulation operates~     periodically, several times a day, and this repetition of doses , akin to the regular~     taking of a medicine, may explain its longer efficacy for pain relief which, may extend over~     several years (André-Obadia and al 2014).~      No study at this date has estimated the long-term effect of non-invasive stimulation when is~     also periodically repeated on a daily basis, over several weeks.~   "
93265|NCT02346383|"~     To determine the best parameters with various leads to cover back and leg pain and provide~     best pain relief~   "
93266|NCT02346370|"~     A Phase 1b study for subjects with Stage IIIB/IV NSCLC to participate in 1 of 2 portions of~     this study. The first portion is Dose Escalation in which subjects are tested with PEGPH20 at~     various doses (1.6, 3.0, 2.2 and 2.8 mcg/kg) in addition to dosing with the standard dose of~     docetaxel of 75 mg/m2 (PDoc) once every 21-day cycle. Based on observations on the safety and~     tolerability of study treatment from dose escalation cohorts dosed to date (1.6 and 3.0~     mcg/kg of PEGPH20), two additional dose levels will be tested, 2.2 and 2.8 mcg/kg. Up to 30~     additional subjects may be enrolled to test these dose levels. The second portion of Phase 1b~     is Cohort Expansion in which the recommended Phase 2 dose (RP2D) of PDoc identified in dose~     escalation is administered every 21 days to approximately 50 subjects with high hyaluronan~     (HA-high) prospectively measured in their tumor tissue.~   "
93267|NCT02346357|"~     Hip arthroscopy is commonly associated with moderate-to-severe postoperative pain. The~     purpose of this study is to investigate the analgesic efficacy of preoperative obturator~     nerve block as measured by postoperative pain scores and postoperative analgesic~     requirements. The primary outcome will be the patient's first reported pain scores in the~     post anesthesia care unit (PACU).~   "
93268|NCT02346344|"~     A multi-year clinical study to improve tools for measuring the function of insulin-producing~     beta cells in people with type 2 diabetes mellitus.~   "
93269|NCT02346331|"~     Sepsis is a clinical syndrome representing deranged hemodynamics (such as tachycardia)~     secondary to severe infection. In high-income countries (HICs), early resuscitation of septic~     patients with protocol-driven therapy, including quantitative fluid administration guided by~     invasive monitoring, has resulted in improved outcomes for septic patients. Prevalence and~     mortality of sepsis are thought to be higher in sub-Saharan Africa (SSA) than in high-income~     countries; however, most hospitals in SSA lack the technology and resources necessary to~     implement the resuscitation protocols used in HICs and therefore, mortality from sepsis~     remains high. The World Health Organization (WHO) has recently disseminated an algorithm for~     resuscitation of septic patients in low resource settings. This algorithm is based on expert~     consensus only, and its efficacy has never been tested.~      This study will be conducted in the Casualty Department of Moi Teaching and Referral Hospital~     (MTRH) in Eldoret, Kenya.~      The purpose of this study is to describe the epidemiology of patients presenting with severe~     sepsis, to examine the microbiology causing severe sepsis, to describe current management and~     outcomes for severe sepsis, and to test the effect of implementation of the WHO resuscitation~     algorithm at MTRH.~      The study design is a prospective before and after clinical trial. In an initial~     observational phase, adult patients presenting to the MTRH Casualty Department with sepsis~     and severe sepsis (the latter of which will be defined by elevated lactate) will be enrolled~     into a prospective observational cohort. Demographic data, medical characteristics, and~     microbiological studies will be obtained, then the management and outcomes of these patients~     will be observed. In a second phase, patients with sepsis will continue to be enrolled into a~     prospective observational cohort, while patients with severe sepsis will be enrolled into an~     intervention group. Patients in the intervention group will be managed according to the WHO~     resuscitation algorithm. Specifically, the WHO algorithm involves fluid boluses guided by~     vital signs and physical exam findings, rapid and early administration of empiric~     antibiotics, and frequent patient monitoring. The outcomes of interest are achievement of~     lactate clearance, which is a correlate of tissue perfusion, as well as 24-hour, in-hospital,~     and 30-day mortality.~   "
98738|NCT02274831|"~     The purpose of this study is to see if patients who receive an email reinforcing their~     discharge instructions after being discharged from the emergency department will have an~     affect on follow-up care with their primary physician.~   "
93271|NCT02346305|"~     The effectiveness of NIV is clearly demonstrated but no recent studies describe the~     prescription based on clinical data and the conditions of using NIV at home according the~     various respiratory diseases.~      The investigators' purpose is that a better knowledge of NIV practices could improve both the~     quality to support patients at home and the efficacy of the treatment.~      The main objective of this study is to analyze the clinical data justifying the prescription~     of NIV advice according respiratory disease. The secondary objectives are to study~     comorbidities, treatment failures, survival rate during the study period.~   "
93272|NCT02346292|"~     The study is an observational multicenter descriptive study. It is planned to enroll~     approximately 1250 subjects with severe and very severe COPD hospitalized for the reason of~     COPD exacerbation into departments of pulmonology or therapy. The study will be conducted in~     approximately 20-25 institutions of treatment and prevention in Russian Federation and will~     include about 50 to 60 subject at each clinical site.~   "
93273|NCT02346279|"~     The aim of this survey is the evaluation of the responsiveness and the estimation of the MCID~     of the German and French Multiple Sclerosis Questionnaire for Physiotherapists, a self-rating~     Patient Reported Outcome questionnaire. This multicenter project uses a combined anchor and~     distribution based approach with multiple anchors to provide a range of MCID estimates or a~     single MCID for the reliable and valid Items, Activity and Participation group and the Total~     Score of the MSQPT, which should to be used as guidelines in daily practice.~   "
93274|NCT02346266|"~     A stroke awareness program for school-aged children to learn the signs/symptoms of stroke,~     teach their parents and make healthy life-style choices.~   "
93275|NCT02346253|"~     This phase I/II trial studies the side effects and how well high-dose brachytherapy works in~     treating patients with prostate cancer that has not spread to other parts of the body.~     Brachytherapy is a type of radiation therapy in which radioactive material sealed in needles,~     seeds, wires, or catheters is placed directly into or near a tumor and may be a better~     treatment in patients with prostate cancer.~   "
93276|NCT02346240|"~     The purpose of this study is to investigate the efficacy and safety of two dose levels of~     certolizumab pegol compared to active comparator and placebo in adults with moderate to~     severe chronic plaque psoriasis.~   "
93277|NCT02346227|"~     1. Introduction Cervical cancer (CC) is a major public health problem in Low-income~          countries (LICs), particularly in the Democratic Republic of the Congo (DRC), where the~          estimated number of cases is 3839 per year. (WHO, 2010).~           Persistent infection with Human Papillomavirus (HPV) is recognized as the necessary~          cause for the development of CC. Thus, CC is a disease that is easily preventable~          primarily by vaccination against HPV and secondarily through screening and treatment of~          precancerous lesions of the cervix.~           In LICs, the high incidence of CC is due to both high rates of infection with HPV, a~          failure to initiate and sustain effective screening programs based on cytology and the~          non-availability of vaccination against HPV. These situations highlight the need to~          implement simple and inexpensive screening and treatment methods suitable for LICs.~          These methods include screening by visual inspection of the cervix after application of~          acetic acid (VIA) and treatment with a topical antiviral drug (AV2).~        2. Aims~           This study aims to:~             -  Evaluate the clinical efficacy of AV2 as a treatment for HPV-associated lesions of~               the uterine cervix;~             -  Identify HPV genotypes found in Kinshasa;~             -  Determine the cost-effectiveness of an algorithm combining screening by VIA and AV2~               and that combining VIA and cryotherapy treatment;~        3. Methods After basic training of local health workers on VIA, on collection of cervical~          samples for HPV testing (quantitative Polymerase Chain reaction, qPCR) and liquid-based~          cytology (LBC) and on application of AV2, a screening and treatment program will be~          offered to women aged 25 and older who will give their informed consent.~      All women with lesions on VIA will be randomized into one of two groups to receive either~     treatment by AV2 or placebo.~      All women with lesions on VIA will be monitored and reviewed after two months and after six~     months for repeat tests (VIA and LBC for lesions, qPCR for viral load, conversion and~     reinfection rates).~   "
93278|NCT02346214|"~     The purpose of this study is to develop a novel, highly automated method of gestational age~     estimation at delivery combining anterior lens capsule vascularity (ALCV) and biophysical~     parameters appropriate for use in low income countries. The specific aims of the proposed~     study are: (1) To develop an algorithm to predict gestational age at delivery from 26 to 42~     weeks' gestation with ALCV and key biophysical parameters (2)To evaluate the performance of~     ALCV and biophysical parameter-based gestational age estimates. Specifically, we hypothesize~     that the accuracy of the predictive algorithm will be comparable to commonly used measures of~     gestational age dating (±2 days) and have better precision (±14 days) than commonly used~     measures of gestational age dating.~   "
93279|NCT02346201|"~     Apathy in Dementia Methylphenidate Trial 2 (ADMET 2) is a Phase III, placebo-controlled,~     masked, 6 month, 10-center randomized clinical trial sponsored by National Institutes of~     Aging involving 200 participants with Alzheimer's disease (AD). ADMET 2 is designed to~     examine the efficacy and safety of methylphenidate as treatment for clinically significant~     apathy in AD participants. ADMET 2 will enroll participants from real world settings such as~     outpatient, nursing home, and assisted living facilities and will examine the effects of~     methylphenidate on apathy and cognition. ADMET 2 will also conduct careful safety monitoring.~   "
93280|NCT02346188|"~     Lead is negatively linked to nutritional status, behavior and cognition in children. Despite~     extensive knowledge of its toxicity and efforts to reduce exposure, lead continues to be a~     problem in developed and developing countries. When lead exposure is unavoidable due to its~     pervasive nature, effective means of protecting or disrupting that exposure need to be~     developed. Nutritional interventions are one such option. We conducted a 2x2 factorial,~     placebo-controlled trial of 6-month iron and zinc supplementation among lead-exposed children~     in Torreón, Mexico (altitude 1060 m). Nine schools were selected based on proximity to a lead~     smelter and first-graders were individually randomized to daily treatment with 30 mg iron, 30~     mg zinc, both, or placebo. In addition to biochemical indicators, cognitive functions and~     behavior were evaluated at baseline, after the 6-month supplementation period, and again~     after another 6 months (without supplementation).~      At baseline, 602 children ages 6.2-8.5 years were enrolled.~   "
93281|NCT02346175|"~     The purpose of this study is to evaluate the pharmacodynamics (PD), pharmacokinetics (PK),~     safety and tolerability following single and multiple oral doses of 5mg to 20 mg SHR3824 in~     Type 2 diabetes mellitus patients.~   "
93356|NCT02345187|"~     The study will aim to compare the effects of a beverage powder fortified with multiple~     micronutrients and Bacopa monnieri extract (test product) to a non-fortified isocaloric~     beverage powder (control product) on cognitive outcomes of attention and working memory.~   "
93549|NCT02342639|"~     The purpose of this study is to determine if Rifaximin decreases serum and urine levels of~     bacterial byproducts and inflammatory markers in patients with chronic kidney disease and to~     evaluate changes in the bacterial content of the stool from these individuals.~   "
93282|NCT02346162|"~     The US obesity epidemic is being transmitted to the next generation. Growing evidence~     suggests that both a mothers' weight at pregnancy onset, and excessive weight gain during~     pregnancy, are associated with increased risk of pregnancy-related complications such as~     gestational diabetes and pre-eclampsia, and an increased risk that her child will become~     obese and face obesity-related health issues in later life.~      Currently, over one-third of reproductive-aged women in the U.S. are obese [body mass index~     (BMI) ≥ 30]. Our research team has shown that we can improve birth weight outcomes in babies~     of obese women who start a weight-management intervention program at 14 to 15 weeks of their~     pregnancy (soon after their first prenatal visit). However, organogenesis and metabolic~     programming begin early in the first trimester, well before the first prenatal visit.~     Therefore, waiting to address mothers' weight, physical activity, and diet quality until the~     first prenatal visit is not optimal. Given the need to reach overweight and obese women prior~     to pregnancy, and the Institute of Medicine's (IOM's) recent recommendation, based on~     observational studies, that women should reach a healthy weight before conceiving, this~     randomized clinical trial will evaluate a comprehensive preconception weight loss program.~   "
93283|NCT02346149|"~     Diabetes Mellitus (DM) includes several metabolic diseases all characterized by high sugar~     levels in the blood. Although diabetic nephropathy is widespread, its underlying~     pathophysiological mechanisms remain poorly understood and, so far, little progress has been~     made to prevent the development of diabetic nephropathy and to delay kidney functions~     decline.~      Increasing amount of data based on animal studies support the pathogenic role of tissue~     hypoxia in the development and progression of diabetic nephropathy. Blood Oxygenation-Level~     Dependent Magnetic Resonance Imaging (BOLD-MRI) is increasingly used in research to measure~     cortical and medullary oxygenation in a non-invasive manner. Interestingly, in two~     cross-sectional clinical studies, we have recently found a positive correlation between high~     circulating blood glucose levels and cortical R2* levels in type 2 DM patients. This~     discovery suggests that an increase in glycemia might acutely decrease renal tissue~     oxygenation.~      The goal of this study is to investigate the impact of serum glucose on renal tissue~     oxygenation in healthy subjects and subjects with glucose intolerance.~   "
93284|NCT02346136|"~     The proposed study will determine whether Tai Chi is an effective and practical intervention~     to improve overall function and lower health care utilization in an expensive, vulnerable~     population of seniors that is more representative of many US communities than those~     previously studied. If the results are favorable, our study will also provide the necessary~     training and protocol manuals to replicate Tai Chi programs in senior housing facilities~     across the nation to help prevent, better manage, and overcome frailty among seniors.~   "
93285|NCT02346123|"~     The purpose of this study is to analyze the influence of polymorphisms of the genes CLDN-1~     (Claudina-1), LGALS3 (Lectin galactoside-binding soluble 3), SOCS3 (Suppressor of cytokine~     signaling 3), IL-28B (interleukin-28B), CCL5 (Chemokine C-C ligand 5) in the determination of~     clinical forms and in the percentage of cardiac fibrosis in patients with Chagas disease.~   "
93286|NCT02346110|"~     This study focuses on optimizing the postoperative pain treatment after major foot and ankle~     surgery by prolonging the duration of the ultrasound-guided saphenous block. The currently~     used single shot saphenous block only covers half of the pain intensive period from the~     saphenous territory, which results in a sharp, break-through pain requiring opioids. The~     hypothesis is that this protracted mixture will keep the patients free of pain without the~     use of opioids for the entire pain intensive period and thus increase rehabilitation and~     patients' satisfaction.~   "
93287|NCT02346097|"~     The purpose of this study is to investigate if optimal electrical resynchronization~     achieved by targeting left ventricular lead placement to the myocardial region with the~     latest electrical activation combined with post-implant pacemakersettings for narrowing the~     paced QRS width causes an excess improvement in the pumping function of the heart (the left~     ventricular ejection fraction) in Cardiac Resynchronization Therapy (CRT)~   "
93288|NCT02346084|"~     The purpose of the study is to evaluate the safety, acceptability, and PK/PD profile of~     maraviroc gel following rectal and vaginal administration. The study also includes oral~     exposure to maraviroc.~   "
93289|NCT02346071|"~     Background:~      An increasing number of adolescents report recurrent functional somatic symptoms. Some~     experience persistent symptoms and may receive functional somatic syndromes (FSS) diagnoses~     (i.e. symptoms not attributable to any known conventionally defined physical disease),~     characterised by severe disability and reduced quality of life.~      The aim of this study is to:~        1. Develop an Acceptance and Commitment Therapy (ACT)-based group intervention for~          adolescents with severe FSS (conceptualized as Bodily Distress Syndrome (BDS), see~          detailed description).~        2. Examine the efficacy of group based ACT in adolescents (aged 15-19 years) with severe~          FSS.~      The ACT-based treatment, with 9 sessions of group therapy and one follow up meeting is~     compared to standard treatment/enhanced usual care, which is one single advisory~     consultation.~      The study includes approximately 120 patients.~   "
93290|NCT02346058|"~     Evaluation efficacy and safety of Esarin Gel in subjects with chronic venous insufficiency or~     varicose veins combine superficial vein thrombophlebitis.~   "
93291|NCT02346045|"~     A. Hypertension is a major cardiovascular risk factor and numerous treatment strategies have~     been developed to treat hypertension properly and reduce cardiovascular risk.~      B. However, there is a subgroup of hypertension which are resistant to treatment.~        1. Resistant hypertension is associated to sympathetic hyperactivity~        2. Renal sympathetic nerve is known to be associated with systemic sympathetic activity~        3. According to research of recent years, catheter based renal sympathetic denervation is a~          safe and effective treatment modality to treat resistant hypertension C. Resistant~          hypertension is observed in end stage renal disease (ESRD) frequently.~      D. Sympathetic hyperactivity is observed in ESRD patients E. Catheter based renal sympathetic~     denervation is expected to improve resistant hypertension in ESRD patients~      F. The aim the present study is to evaluate the effects and safety of catheter based renal~     sympathetic denervation on resistant hypertension in ESRD~   "
93292|NCT02346032|"~     Phase II Study of Refametinib, a MEK inhibitor, as second-line treatment in advanced biliary~     tract adenocarcinoma~   "
93293|NCT02346019|"~     The purpose of our study is to improve the fit and function of prosthetic sockets for above~     the knee amputees through the use of an outpatient thigh reduction surgical procedure.~   "
93294|NCT02346006|"~     An increasingly physical inactive lifestyle in the Western World has led to a higher number~     of lifestyle -related diseases. The consequences are now already present in childhood with an~     increased prevalence of overweight, obesity, and diabetes. Inactivity is also accompanied by~     cardiovascular iseases and is also thought to be associated with an increased incidence of~     nearsightedness (myopia).~      Myopia is the most frequent eye disease globally, and causes severe personal and societal~     expenses and may additionally lead to secondary eye disorders such as retinal detachment,~     glaucoma, and cataract.~      The retina is the only place in the human body where it is possible to directly inspect the~     blood vessels (microvasculature). Photography of the eye background allows a noninvasive~     examination of the retinal structure in which it is possible to make measurements on the~     retinal blood vessels.~      It is well known that early vascular chances can be detected with this method and that there~     are correlation between these changes and systemic diseases, such as hypertension, stroke and~     other cardiovascular diseases.~      This study is a new subproject in The Childhood Health, Activity, and Motor Performance~     School (CHAMPS) Study Denmark, also known as the Svendborg Project. The project has a~     well-defined cohort with originally 1515 school students who since 2007 have been divided~     into two groups: schools with extra exercise during school hours and matched traditional~     schools. CHAMPS-DK aims to investigate the effect of increased physical activity on current~     and future health of children and adolescents.~      Thanks to this unique child cohort it is possible to investigate the correlation between~     physical activity, myopia and retinal vascular diameters in a large group of Danish~     schoolchildren. We want to study the degree and reversibility of physical activity and its~     effect on the development of myopia and retinal blood vessel changes. However, there is still~     a lack of knowledge about the correlation between physical activity and retinal vascular~     diameters in children. Furthermore, it is still unclear whether physical activity can prevent~     the development of myopia; such a realization could have far-reaching consequences in form of~     a modified approach to the necessity for exercise and, furthermore, potentially a significant~     socio-economic benefit.~   "
93295|NCT02345993|"~     The purpose of this study is to determine whether extra fine formoterol/beclomethasona are~     more effective in the treatment of asthmatic crisis when added to conventional treatment~     compared with conventional treatment alone.~   "
93296|NCT02345980|"~     Despite its beneficial effect, ureteral stents may produce symptoms (such as hematuria,~     dysuria, frequency, urgency, urge incontinence and suprapubic or flank pain) that affect the~     quality of life in 70-80%.~      This study will be conducted to evaluate the role of Phosphodiestrase 5 inhibitor (Sildenafil~     Citrate) in relieving these symptoms.~   "
93297|NCT02345967|"~     The purpose of this study is to verify safety and assess tolerance of a long-term, implanted~     glucose monitoring sensor. The study will also provide data to characterize the response~     properties and calibration of the implanted sensor and determine if such properties vary with~     implant duration.~   "
93298|NCT02345954|"~     The purpose of this study is to compare the operative, anatomic functional outcome as well as~     the subjective outcome of laparoscopic supracervical hysterectomy and sacropexy compared to~     laparoscopic hysteropexy (conserving the uterus).~      The investigators expect that both laparoscopic procedures are equal in regards to operation~     time, complication rate, anatomic and functional outcome as well as subjective outcome.~   "
93299|NCT02345941|"~     This project will utilize the first web-based program to provide tailored injury prevention~     education. The existing Safety in Seconds program was adapted into a smartphone platform.~     Parents are recruited from and engage in the program in the clinical setting (PED or PTS).~     Parents download the app onto their smartphone which is used to ask the questions, collect a~     parent's responses, assess the parents' safety needs and give tailored directions for proper~     car sear use. The control group parents will also engage with the smartphone app and receive~     immediate feedback. However, they will receive tailored educational messages about smoke~     alarms. Parents will also have access to the online SIS v 2.0 Parent Portal which will have~     educational features (e.g., tips for keeping children content in their CSSs, links to helpful~     websites). The investigators will use emerging technology such as push notification and email~     to remind parents to visit the portal and have their child's car seat reassessed.~      The investigators plan to conduct a cost benefit analysis of the program's expected financial~     benefit from the perspective of a third party payer of medical claims and an in-depth~     examination of program adoption and implementation using qualitative data collected from key~     informant interviews, direct observations of the clinic environments, and document review.~   "
93300|NCT02345928|"~     The purpose of this study is to evaluate the safety and tolerability of single ascending dose~     of CNTO 7160 administered intravenously (IV) in healthy participants and multiple dose~     administered IV in participants with asthma and atopic dermatitis.~   "
93301|NCT02345915|"~     Taking into account the specificities of adolescent and young adult cancer patients led~     agencies (in particular the French National Cancer Institute INCa, through the last Cancer~     Plan), to initiate projects targeting this population. Acute leukemia is among the most~     common cancers in adolescents and young adults. Recent therapeutic advances now allow hope~     for a cure in about 50% of this population. The issue of post-cancer is therefore of~     particular importance for young adults with cancer. Our aim is to establish the health~     determinants in young adult leukemia survivors and to compare the frequency of these effects~     and their explanatory factors to the data collected in children or adolescent leukemia~     survivors program (LEA). 90 patients followed up at the Institut Paoli-Calmettes cancer~     center and Nice University Hospital have been identified and would be included in this~     study.Collected data will include information on the initial disease and its treatments,~     physical sequelae (fertility, thyroid function, heart function, visual function, secondary~     tumors, viral infections, lung function, bone metabolism, iron metabolism, metabolic~     syndrome, osteonecrosis, alopecia ... ), quality of life, social and occupational integration~     and relationship with care system.~   "
93302|NCT02345902|"~     Haloperidol and Non-Pharmacologic Treatment are recognized treatments for delirium. This~     study will evaluate which is the best treatment for hypoactive delirium.~   "
93303|NCT02345889|"~     Adenoma detection rate (ADR) is a validated marker for reducing the risk of interval~     colorectal cancer after a screening colonoscopy. Recent studies suggest that novel devices~     attached to the colonoscope tip may improve the ADR of doctors performing a screening~     procedure~   "
93328|NCT02345551|"~     This project will assess the feasibility of a 12-week physical activity program developed~     specifically for females exposed to a known occupational carcinogen - shiftwork. Physical~     activity has been shown to decrease cancer risk, but the investigators research has found~     that female shift workers face unique barriers to participating in physical activity. This~     project will use a combination of telephone-based behavioural counseling sessions with a~     physical activity coach, and innovative web-based physical activity tracking software using a~     Fitbit and website or smartphone app to address commonly reported barriers to physical~     activity in female shift workers.~   "
93384|NCT02344823|"~     The investigators want to analyze the effect of Vardenafil on Erectile Dysfunstion and portal~     hemodynamics in patients with liver cirrhosis.~   "
93304|NCT02345876|"~     The hypothesis of central auditory processing disorders has been advanced to explain the~     anomalies of the grapheme/phoneme combination in some dyslexia. These phonological disorders~     may be linked to abnormalities of the efferent (medial olivocochlear) system modulation and~     of cortical asymmetry. Indeed, the efferent system has an asymmetry in relation to~     handedness. Thus, in right-handed subject, it is predominant on the right side. In contrast,~     in the subject-handed dyslexic, the efferent system tends to be right-lateralized or~     non-lateralized. However, after an audio-visual training, normal lateralization can appear.~     This maturation of the efferent system lateralization during reading acquisition seems to~     have a particular profile in dyslexics with phonological disorder, especially if it is~     persistent. This finding allows to consider new prognostic evaluation and speech therapy~     rehabilitation in the dyslexic child.~   "
93305|NCT02345863|"~     A prospective, open-label, multicenter Phase-II trial to evaluate the efficacy and safety of~     a sequential regimen of Bendamustine followed by GA101 and Ibrutinib followed by Ibrutinib~     and GA101 maintenance in CLL patients.~   "
93306|NCT02345850|"~     The study is designed as a three arm randomized Phase III, multicenter trial comparing two~     calcineurin inhibitor (CNI)-free strategies for Graft-versus-Host Disease (GVHD) prophylaxis~     to standard tacrolimus and methotrexate (Tac/Mtx) in patients with hematologic malignancies~     undergoing myeloablative conditioning hematopoietic stem cell transplantation.~   "
93307|NCT02345837|"~     The aim of this study is to detect whether or not performing an endometrial sampling in the~     cycle preceding ovulation induction with clomiphene citrate can improve pregnancy outcomes in~     the next cycle.~   "
93308|NCT02345824|"~     This is a single-institution, open-label, early-phase study to assess the ability of~     ribociclib (LEE011) to inhibit CDK4/CDK6/Rb/E2F signaling and cell proliferation/viability in~     core and infiltrating tumor tissues obtained from patients with recurrent glioblastoma or~     anaplastic glioma compared to the baseline/primary pathologic tumor specimen. Abundant~     preclinical evidence indicates that Rb-deficient cancer cells are resistant to CDK4/6~     inhibition and ongoing trials with CDK4/6 inhibitors exclude patients with Rb-deficient~     tumors. The investigators will evaluate 10 patients with Rb-positive glioblastoma or~     anaplastic glioma in this study. Given that a minority of glioblastomas ha Rb loss the~     investigators anticipate enrolling a maximum of 20 patients, to meet our goal of 10 patients~     with Rb-positive tumors.~   "
93309|NCT02345798|"~     This pilot clinical trial studies a video-assisted intervention in improving recovery of~     patients undergoing surgery to remove lung cancer or cancer that has spread to the lung and~     their caregivers. The intervention uses educational videos to prepare patients and families~     for surgery and teach them how to manage the symptoms after surgery. Teaching patients and~     their families what to expect before and after surgery may help improve patient and caregiver~     quality of life, help patients recover better from surgery, and support families in their~     role as caregivers after surgery.~   "
93310|NCT02345785|"~     The purpose of this study is to evaluate the change of penile corpus cavernosum after caudal~     block using ultrasonography in pediatric patient.~   "
93311|NCT02345772|"~     Hormonal therapy administered before surgery in ER-positive and HER2-positive patients with~     breast cancer.~   "
93312|NCT02345759|"~     Dietary management of CKD patients proved important to postpone dialysis. Long-term~     compliance to protein-restricted diets was discussed. Psychological aspects involved in~     certain dietary behaviour have never been studied.~   "
93313|NCT02345746|"~     In this study, Hepatic Arterial Infusion will be combined with systemic therapy for patients~     with liver-only or liver-predominant metastases who have failed at least one line of systemic~     chemotherapy.~   "
93314|NCT02345733|"~     The goal of the study is to evaluate strategies that target the microbiota for the treatment~     of Ulcerative Colitis , This study will involve a novel diet that the investigators developed~     , based on the hypothesis that UC involves dysbiosis , underutilzation of certain metabolic~     pathways and use of pathways that increase risk of inflammation . The investigators have~     postulated that manipulation of colonic bacterial metabolism with this diet will induce~     remission in UC without involving additional immune suppression.~   "
93315|NCT02345720|"~     The purpose of this study is to evaluate the etafilcon - PVP (multi-focal)~   "
93316|NCT02345707|"~     This study is a single-center, randomized, open-label, two cohorts, 3-way cross-over design~     in 36 subjects to assess the oral bioavailability of four new cabotegravir (CAB) sodium salt~     tablet formulations relative to the current CAB sodium salt formulation being used in the~     phase IIb studies under fasting conditions. All treatments will be administered as single 30~     mg doses of CAB. Safety evaluations and serial PK samples will be collected during each~     treatment period. A follow-up visit will occur 10 - 14 days after the last dose of study~     drug. Treatment period doses will be separated by a 14 day washout. Participation in this~     study will be approximately 12 weeks.~   "
93317|NCT02345694|"~     The purpose of this randomised controlled study is to determine the impact of continuous~     positive airway pressure (CPAP) versus sub-therapeutic CPAP (placebo) on the control of gait~     upon severe sleep apnea patients, based on stride time variability.~   "
93318|NCT02345681|"~     Patients admitted in the Intensive Care Unit (ICU) frequently display and excessive fluid~     balance over a very short period of time. This positive fluid balance is the consequence of~     different organ failures (pulmonary, cardio-vascular, kidney…) or aggressive fluid~     resuscitation, which is mandatory in the early phase of ICU course. However recent data~     strongly suggest that an excessive fluid balance could be detrimental per se (increase of ICU~     morbidity or even mortality). There are controversies regarding the potential benefit of~     controlling this fluid balance with diuretics which are commonly used worldwide in various~     indications (acute and chronic heart failure, chronic kidney failure). In the ICU literature~     data are lacking, regarding the possible advantages and drawbacks of diuretics in this~     indication. The aim of our study is to test an algorithm with furosemide to reduce fluid~     overload in severe ICU-patients.~   "
93319|NCT02345668|"~     The aim of this study is to assess the efficacy of a Transdiagnostic Internet-based Protocol~     (Emotion Regulation Protocol) for the treatment of unipolar mood disorders (major depression~     and dysthimia) four anxiety disorders (Panic disorder, agoraphobia, generalized anxiety~     disorder and social anxiety disorder) and obsessive-compulsive disorder in comparison with~     Treatment as Usual in specialized care (Spanish public mental health system).~   "
93320|NCT02345655|"~     In France, General Practitioners (GPs) are widely involved in opiate maintenance treatment~     (OMT) by initially prescribing buprenorphine and monitoring patients under buprenorphine and~     methadone. Number of treated patients is around 150,000 with 75% of them treated by~     buprenorphine. Among the guidelines for improving OMT, urine testing is mandatory for~     initiating methadone, whereas it is recommended for initiating buprenorphine and during~     follow-up. Urine drug tests are based on immunoassay techniques and enable a qualitative~     analysis of the recent drug consumption, with detection based on designated thresholds, allow~     a better appraisal of drug exposure, before initiating and during OMT. While intrinsic~     diagnostic value of these tests is already demonstrated, the consequences of carrying out~     these tests on OMT have not been clearly established. Some studies suggest that patients~     exposed to drug tests may have a better OMT retention and in patients treated by methadone,~     performing urine screening tests has been shown to be associated with a mortality risk~     reduction in a Scottish retrospective cohort of opioid addicts. Actually, despite the~     recommendations to perform these tests, few GP prescribe tests, and few patients are~     regularly screened. Availability of commercial kits for urine drug testing in the medical~     office should improve their utilisation.~      The widespread of urine drug screening tests use in ambulatory care is a reality for some GPs~     working in addictology networks. Despite a global benefit reported in the literature with a~     better control in prescribing OMT and a better patients' adherence, as far as the~     investigators know, no study has yet explored the impact of the use of urine drug screening~     test in decision making in general practice with an intervention study.~   "
93321|NCT02345642|"~     We are comparing two pneumatic compression devices, VenaFlow (stationary) and MCS (portable)~     in both the supine an standing position. We will start supine and will take 3 baseline~     measurements of venous velocity and then apply a device and take 3 measurements of the~     increase in peak venous velocity. We will repeat this with the second device. We will then~     have the subject stand and repeat the above with each device. We will randomize the order of~     the devices in the supine and standing position. This study will involve 10 healthy subjects~     of various ages and 10 total hip replacements (THR) patients.~   "
93322|NCT02345629|"~     The goal of this clinical research study is to learn if a cordotomy reduces pain in patients~     with unmanageable cancer pain. A cordotomy is a procedure, guided by computed tomography (CT)~     scans, that is performed on the spinal cord and is designed to reduce pain transmission.~   "
93323|NCT02345616|"~     The pulmonary hypertension (HTP) due to a left heart disease or a hypoxemiant lung disease is~     frequent in cardiac surgery. The HTP represents an independent risk factor of morbidity and~     mortality in cardiac surgery, entering to the criteria of Euroscore evaluation (European~     System for Cardiac Operative Risk Evaluation).~      An acute perioperative hemodynamic decompensation of these patients is frequent.~     Perioperative hemodynamic modifications, hypoxemia, hypercapnia, sympathetic stimulation,~     increase pulmonary vascular resistances (RVP) and might provoke right ventricular failure.~      The anesthetic induction and the beginning of mechanical ventilation are the most sensible~     times due to the risk of hemodynamic decompensation. The suppression of the sympathetic tonus~     which is consequence of the anesthetic induction, decrease the systemic vascular resistances~     and lead to decrease of blood pressure. In return, the anesthetic induction is associated~     with an increase of pulmonary vascular resistances, resulting in increase of the postcharge~     and the work of the right ventricle (VD). These systemic and pulmonary hemodynamic~     modifications can lead to equalization, or even an inversion of the systemic and pulmonary~     pressures. As consequence, a hemodynamic collapse or even a heart arrest can arise.~      The patients suffering from HTP are hypoxemic. They have very limited oxygen reserves due to~     decrease of the functional residual capacity (CRF). The apnea period, which follows the~     anesthetic induction, is often associated with a fast desaturation, even if a good~     pre-oxygenation was performed before. This desaturation causes an increase of the pulmonary~     vascular resistances with the hemodynamic consequences previously mentioned. A risk of~     hypoxic heart arrest is also present.~      Nitric Oxide (NO) is an endogenous mediator produced from the vascular endothelium. The NO is~     a powerful vasodilator and is used in intensive care in inhaled way as selective pulmonary~     vasodilator (iNO). NO decreases the RVP, the shunt effect and improves the oxygenation by~     optimization of ventilation-perfusion ratio. The short lifetime of iNO (6sec approximately)~     allows a fast metabolism without inducing any undesirable effects such as the systemic~     hypotension.~      No studies, until now, have investigated the use of iNO in pre-oxygenation before anesthetic~     induction in cardiac surgery.~      We hope to demonstrate that iNO used in oxygenation before anesthetic induction will have a~     beneficial effect on the respiratory and cardiovascular parameters.~      Our objective is to estimate the feasibility and the tolerance of iNO before anesthetic~     induction of the patients with a moderate or severe HTP programmed for cardiac surgery with~     extracorporeal circulation. The effect will be estimated in terms of efficiency (hemodynamic~     and respiratory optimization).~   "
93324|NCT02345603|"~     Non-randomized study of 5 subjects that have been selected for prophylactic open surgery due~     to abdominal aortic aneurysm. During surgery the renal arteries are identified and subjected~     to about 60 seconds each of freezing by application of liquid nitrogen in dedicated catheters~     around the circumference of each artery. Another 5 patients that are not subjected to the~     freeze therapy serve as controls. Main outcome is change in ambulatory blood pressure levels.~   "
93325|NCT02345590|"~     Weakening and expansion of the main abdominal artery (abdominal aortic aneurysm, AAA) is a~     common problem in older Australians. The majority of AAAs are small (<55 mm) and affect~     90,000 individuals in Australia and 4.5 million world-wide. Currently, the only treatment~     available for AAA is surgery. However, surgical therapies are not effective for small AAAs,~     and these patients undergo a program of repeat imaging and consultation to monitor the size~     of the aneurysm and symptoms.~      This proposal is aimed at addressing the urgent need to identify a medical treatment able to~     limit progression of AAAs.~      The study design and rationale are based on strong preclinical evidence supporting the value~     of eplerenone (an agent indicated for treatment of heart failure) in limiting AAA~     progression. If proved effective, this medication would:~        1. Reduce the number of patients requiring costly surgery~        2. Reduce the number of surgery related deaths and complications~        3. Provide a therapy suitable for the rapidly expanding elderly age group who have AAAs.~   "
93326|NCT02345577|"~     Kidney recipients loose significant amounts of muscle mass and skeleton minerals in the early~     post-transplantation period and suffer from increasing abnormalities of neuromuscular~     functions.~      Stochastic whole body vibration (WBV) therapy is a relatively new form of movement~     physiotherapy that is used for strength training. Various clinical studies have shown that in~     addition to muscle function, WBV also improved body balance and bone mineral density. To~     study the impact of stochastic WBV physiotherapy on musculoskeletal parameters after renal~     transplantation, kidney transplant recipients will be enrolled and undergo WBV. The~     investigators hypothesize that WBV physiotherapy improves both maximum muscle strength and~     muscular performance~   "
93327|NCT02345564|"~     Osteochondral lesions in knee and ankle are injuries commonly seen in young patients.~     MaioRegen fleece is a cartilage substitute which can be used in circumscribed defects.~      This prospective study follows patients treated with MaioRegen implants from pre-surgery~     until 24 months post-surgery.~   "
98760|NCT02274545|"~     H7N9 viruses have caused an outbreak of severe respiratory disease in 2013-2014 in China that~     affected many older adults. This study will evaluate the safety of and immune response to a~     live attenuated H7N9 vaccine in adults 50 to 70 years old.~   "
93331|NCT02345512|"~     People with learning disabilities (LDs) experience high levels of health problems, including~     cerebral palsy, other problems associated with posture, movement and function, and injury~     (falls are the commonest cause of injury in this population, and poor balance/coordination~     are a contributory factor). The aim of this project is to investigate the clinical and cost~     effectiveness of lycra splinting garments (LSGs), worn to improve posture, movement and~     function, for adults (16 years and over) with LDs who fall. This project aims to investigate~     the clinical and cost effectiveness of LSGs to prevent future falls of adults with LDs, to~     inform practice and guidelines within local and national NHS adult services.~      Falls and fall injury are a serious problem for people with LDs (people with LDs experience~     similar rates of falls as the elderly in the general population but at a younger age),~     whereby interventions are warranted. Labbased 3D movement analysis will be conducted with~     adults with LDs who fall during two visits to perform simple tasks (e.g. walking) (once prior~     to being provided with LSG, and once 6 weeks after wearing the LSGs at home).~   "
93332|NCT02345499|"~     To date, no trials have been designed to compare open Vs laparoscopic radical cystectomy in~     the elderly patients, both in terms of functional and clinical outcome measures. A more~     meaningful comparison of the two modalities is that of a randomized controlled trial.~   "
93333|NCT02345486|"~     The administration of intravenous crystalloids is ubiquitous in the care of the critically~     ill. Commonly available crystalloid solutions contain a broad spectrum of electrolyte~     compositions including a range of chloride concentrations. Recent studies of associated~     higher fluid chloride content with acute kidney injury and mortality but no large, randomized~     trials have been conducted. In preparation for a large, cluster-randomized,~     multiple-crossover trial comparing 0.9% sodium chloride to physiologically-balanced isotonic~     crystalloids (Lactated Ringers or Plasmalyte-A) in intensive care unit patients, this pilot~     study will enroll all patients admitted to the medical intensive care unit at a single~     tertiary center for a sixth month period. The primary objective will be to test the ability~     of an electronic order entry tool to ensure administration of assigned study fluid or record~     contraindications to assigned study fluid. The pilot study will also demonstrate the~     feasibility of collecting demographic, severity of illness, fluid management, vital sign,~     laboratory, acute kidney injury and renal replacement therapy, and outcome data in an~     automated, electronic fashion.~   "
93334|NCT02345473|"~     Very few factors may be identified as prognostic for patients with bladder cancer undergoing~     radical cystectomy. Recently, detection of circulating tumor cells has shown to be very~     promising in anticipating both the likelyhood of distant metastases and survival in patients~     with breast cancer, melanoma, prostate cancer and other malignancies. In the present study we~     both tested the detection rate of circulating tumor cells using a PCR based methodology in~     the peripheral blood of patients undergoing radical cystectomy, and we further correlated our~     results with their clinical outcome.~   "
93335|NCT02345460|"~     This phase II trial studies how well combination chemotherapy works in treating patients with~     pancreatic cancer before undergoing surgery. Drugs used in chemotherapy, such as irinotecan~     hydrochloride, oxaliplatin, leucovorin calcium, and fluorouracil (FOLFIRINOX), work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Giving more than one drug~     (combination chemotherapy) before surgery may make the tumor smaller and reduce the amount of~     normal tissue that needs to be removed.~   "
93336|NCT02345447|"~     The purpose of this study is to study whether a herbal-based medication is superior to~     placebo for prevention of acute otitis media in pre-school children with upper respiratory~     tract infection.~   "
93337|NCT02345434|"~     Fraud and waste is estimated to cost the American health care system nearly $200 billion each~     year, and the public Medicare and Medicaid programs about $60 billion each year. This study~     will evaluate a new method for fighting fraud: mailing informative letters to outlier~     providers to notify them of their aberrant behavior. These letters are targeted at high~     prescribers of schedule II controlled substances in Medicare Part D. The investigators will~     look at the effects of these letters on the behavior of providers and their patients. These~     effects are of substantial policy interest as they suggest how to best design anti-fraud~     policies. They are also of academic interest, shedding light on the behavior of physicians~     and their patients.~   "
93338|NCT02345421|"~     The objective of this study is to determine the frequency of Lysosomal Acid Lipase Deficiency~     (LAL D) by lysosomal acid lipase (LAL) enzyme activity assay in patients who are considered~     to be at risk.~   "
93339|NCT02345408|"~     This is an open-label phase 1-b study to evaluate the safety and efficacy of CCX872-B in~     patients with pancreatic adenocarcinoma also receiving FOLFIRINOX chemotherapy.~   "
93340|NCT02345395|"~     The study is designed to evaluate the efficacy and safety of minimally invasive neurosurgical~     techniques for patients with incidental cerebral aneurysms of the anterior circulation in the~     Hospital das Clínicas of the University of São Paulo Medical School.~   "
93341|NCT02345382|"~     To determine the safety, tolerability, pharmacokinetics, maximum tolerated dose, and~     recommended Phase II dose of BAY1143572 in a once-daily or an intermittent dosing schedule in~     subjects with advanced acute leukemia~   "
93342|NCT02345369|"~     The purpose of this study is to look at the effect of locking or not locking a set screw when~     placing a rod and screws device in the thigh bone and hip to fix hip fractures. The set screw~     is an extra screw in the device that will not allow the screw that goes into the ball of the~     ball and socket joint in the hip to slide at all in relation to the rod in the thigh bone,~     which it goes through. It is not known whether it is better to lock the set screw (not allow~     sliding of the hip screw) or leave it unlocked (allow sliding of the hip screw). Participants~     in this study are patients with intertrochanteric hip fractures receiving standard care for~     this injury (lining the fracture up in a normal position and inserting a rod in the thigh~     bone with a screw that goes through the rod into the ball of the ball and socket of the hip).~     Patients who consent to participate will be randomized to one of two arms : 1. Set screw is~     unlocked or 2. Set screw is locked. Participants will all get standard postoperative care and~     standard postoperative xrays.~   "
93550|NCT02342626|"~     The overall goal of this project is to test an interactive, multi-media decision aid in the~     form of an electronic clinical decision dashboard designed to improve the quality of clinical~     decision making for initial treatment of patients with newly diagnosed, low or intermediate~     risk prostate cancer.~   "
93343|NCT02345356|"~     Caribbean Hispanics are a population with a disproportionately high prevalence of~     cardio-metabolic disorders but with a limited expectation of benefits from current~     pharmacogenetic algorithms derived mainly in subjects of relatively pure ancestry. The~     investigators focus on warfarin responses to develop urgently-needed DNA-driven prescription~     guidelines for this population, who have arisen from European, West African and Amerindian~     genomic origins to produce a highly heterogeneous population. Our project combines admixture~     analysis and DNA-sequencing with development of more accurate rules for better predictability~     of warfarin dosing to immediately serve this medically underserved population.~   "
93344|NCT02345343|"~     The primary objective of the study is to report adverse events of on-treatment AEs by the~     treating physicians during a specified 24-month study period in patients with venous~     thromboembolism at the sentinel site(s) for the National Center of Pharmacovigilance (CNFV)~     in Mexico.~   "
93345|NCT02345330|"~     This study will assess the safety and effectiveness of ImmunoPulse IL-12® in~     treatment-refractory metastatic and unresectable squamous cell carcinoma of the head and neck~     (HNSCC). ImmunPulseIL12® is the combination of intrtumoral interleukin-12 gene (also known as~     tavokinogene telseplasmid [tavo]) and in vivo electroporation-mediated plasmid~     deoxyribonucleic acid [DNA] vaccine therapy (tavo-EP) administered using the OncoSec Medical~     System (OMS). Intratumoral tavo is a gene therapy approach to directly induce a~     pro-inflammatory response within a tumor to initiate and/or enhance anti-tumor immunity.~   "
93346|NCT02345317|"~     Age-related macular degeneration (AMD) is the leading cause of irreversible blindness in~     industrial countries. Reticular pseudodrusen (RPD) have been recognized as an additional~     phenotypic characteristic frequently observed in patients with AMD. Several studies have~     proven that the prevalence of RPD is associated with AMD as well as a high risk of disease~     progression to geographic atrophy, the late form of dry AMD. The pathogenesis of RPD is yet~     still incompletely understood. Retrospective studies have demonstrated that the RPD affected~     retinal area increases over time. Potential factors influencing progression of RPD have not~     been intensely studied and potentially predictive markers are yet unknown. The primary~     objective of this study is to characterize RPD progression in more detail and to identify~     predictive markers of RPD progression and development of AMD late stages.~   "
93347|NCT02345304|"~     To assess the influence of different dose strengths of BI 1181181 on single dose kinetics of~     midazolam (CYP3A4 probe drug), warfarin (CYP2C9 probe drug), omeprazole (CYP2C19 probe drug)~     and digoxin (P-gp probe drug)~   "
93348|NCT02345291|"~     A multicenter, Phase 2a, randomized, double-blind, placebo (vehicle)-controlled,~     parallel-group, dose-finding study designed to evaluate the efficacy, safety and tolerability~     of NRD135S.E1 in adult patients with diabetes mellitus type 1 or 2 with neuropathic pain.~     Potential study patients will sign informed consent prior to undergoing any study-related~     procedure.~   "
93349|NCT02345278|"~     Allergic rhinitis/rhinoconjunctivitis is a symptomatic disorder of the nose induced by an~     immunoglobulin E (IgE) mediated inflammatory response. Treatment may involve pharmacotherapy~     and specific immunotherapy (IT). IT represents the only treatment that might alter the~     natural course of the disease. The amount of administered allergen is crucial for both~     efficacy and safety of specific IT. SUBLIVAC FIX Mite mixture is a preparation for sublingual~     IT (SLIT) and is indicated for the treatment of allergic disorders such as allergic rhinitis~     and rhinoconjunctivitis, caused by sensitisation to house dust mite (HDM) allergens.~      According to the European Medicines Agency Guideline on the clinical development of products~     for specific IT for the treatment of allergic diseases, products should be tested at~     different dosages to provide preliminary data on safety and tolerability with regard to the~     maximum tolerated dose and suitable dose escalation scheme. This trial is designed to~     investigate the tolerability and safety of different dosages of SUBLIVAC FIX Mite mixture.~   "
93350|NCT02345265|"~     This phase II trial studies how well olaparib and cediranib maleate work in treating patients~     with ovarian, primary peritoneal, or fallopian tube cancer that has come back (recurrent).~     Olaparib and cediranib maleate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth.~   "
93351|NCT02345252|"~     The primary objective of this study is to evaluate the noninferiority of switching to~     emtricitabine/rilpivirine /tenofovir alafenamide (FTC/RPV/TAF) fixed-dose combination (FDC)~     as compared to continuing FTC/RPV/tenofovir disoproxil fumarate (TDF) FDC (FTC/RPV/TDF) in~     virologically suppressed HIV-1 infected participants.~   "
93352|NCT02345239|"~     The purpose of this study is to demonstrate the immediate impact of pantoprazole on 24-H~     glycemic control and on post-prandial glucose excursion in patients with type 2 diabetes.If~     our data support the previous animal, observational and clinical studies results, PPIs could~     become a new anti-diabetic agent with a good and safe profile for type 2 diabetes~   "
93353|NCT02345226|"~     The primary objective of this study is to evaluate the non-inferiority of switching to~     emtricitabine/rilpivirine/tenofovir alafenamide (FTC/RPV/TAF) fixed dose combination (FDC) as~     compared to continuing the non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen of~     efavirenz /FTC/tenofovir disoproxil fumarate (EFV/FTC/TDF) FDC in virologically-suppressed~     HIV-1 infected participants.~   "
93354|NCT02345213|"~     The purpose of this study is to confirm the efficacy of Aricept in patients with dementia~     with Lewy bodies (DLB).~   "
93355|NCT02345200|"~     Ataxia telangiectasia (A-T) is a rare devastating human recessive disorder characterized by~     progressive cerebellar ataxia, immunodeficiency, chromosomal instability, and cancer~     susceptibility. In addition to that, a high percentage of patients show dystrophy, growth~     retardation and poor weight gain. Nevertheless, there are only a few studies assessing this~     problem. Aim of the present proposal is to investigate the exact body composition, manual~     muscle strength and hormonal status in patients with A-T compared to healthy controls matched~     for gender and age. A pelvic sonography in females was performed in order to evaluate the~     sexual maturity of their inner genitalia. Tanner score was determined to define the physical~     development. Every subject received a nutritional diary to review its calorie intake and the~     quality of diet. The investigators expect that the A-T cohort shows an altered body~     composition, impaired muscle strength, changed hormonal status concerning the sexual hormones~     and a delayed physical development compared to healthy controls.~   "
98782|NCT02274259|"~     Comparing ranibizumab and aflibercept in a treat and extend algorithm evaluating the number~     of needed injections over a 18 month period in patients with newly diagnosed CRVO.~   "
93357|NCT02345174|"~     Human epidermal growth factor receptor 3 (HER3) expression is seen across a wide variety of~     solid malignancies and is associated with poor prognosis. Up-regulation of HER3 expression~     and activity is also associated with resistance to multiple pathway inhibitors. GSK2849330, a~     monoclonal antibody (mAb) targeting HER3, is a new agent for subjects whose tumors express~     HER3. This study aims to characterise the biodistribution and dose-receptor occupancy~     relationship of GSK2849330 in patients with advanced HER3 expressing solid tumours via the~     use of PET imaging. This study will be conducted in two parts. Part 1 will be the imaging~     phase where each subject will receive two doses of GSK2849330 containing both Zirconium-89~     (89Zr) labelled GSK2849330 and unlabeled GSK2849330. The amount of unlabeled GSK2849330~     present in each dose will be varied to explore the effect on target mediated uptake of 89Zr~     into HER3 expressing tissues and tumors. Subjects will then proceed to the continuation phase~     (Part 2) for continued treatment with unlabelled GSK2849330. The study is planned to enroll~     approximately 12-15 subjects.~   "
93358|NCT02345161|"~     This is a phase IIIa, randomised, double-blind, double-dummy, parallel group multicenter~     study evaluating once daily FF/UMEC/VI (100 microgram [mcg]/62.5 mcg/25 mcg) inhalation~     powder versus twice daily budesonide/formoterol (400 mcg/12 mcg). The primary purpose of this~     study is to demonstrate improvements in lung function and health status for subjects treated~     with FF/UMEC/VI compared with budesonide/formoterol for 24 weeks. Once-daily 'closed' triple~     therapy of a Inhaled Corticosteroid/ Long-acting Muscarinic Receptor Antagonists/ Long Acting~     Beta-Agonist (ICS/LAMA/LABA) combination FF/UMEC/VI (100 mcg/62.5 mcg/25 mcg) in a single~     device is being developed with the aim of providing a new treatment option for the management~     of advanced (GOLD Group D) COPD which will reduce the exacerbation frequency, allow for a~     reduced burden of polypharmacy, convenience, and increase the potential for improvement in~     lung function, Health Related Quality of Life (HRQoL) and symptom control over established~     dual/monotherapies.~      Subjects meeting all inclusion/exclusion criteria and who have successfully completed all~     protocol procedures at the Screening Visit will enter the two-week run-in period. Following~     the run-in period, eligible subjects will be randomised (1:1) to one of the following~     double-blind treatment groups: FF/UMEC/VI 100 mcg/62.5 mcg/25 mcg via the ELLIPTA™ dry powder~     inhaler (DPI) once daily in the morning and placebo via reservoir inhaler twice daily OR~     Budesonide/formoterol 400 mcg/12 mcg via reservoir inhaler twice daily and placebo via the~     ELLIPTA DPI once daily in the morning.~      The target enrollment is 1800 randomised subjects at approximately 200 study centers~     globally. The total duration of subject participation will be approximately 27 weeks,~     consisting of a 2-week run-in period, 24-week treatment period and a 1-week follow-up period.~     Subjects will run-in on their existing COPD medications for 2 weeks and in addition will be~     provided with short acting albuterol/salbutamol to be used on an as-needed basis (rescue~     medication) throughout the study. Subjects will discontinue all existing COPD medications~     during the randomised treatment period but may continue their study supplied rescue~     albuterol/salbutamol. A sub-set of approximately 400 subjects will remain on blinded study~     treatment for up to a total of 52 weeks to provide additional long term safety data.~      ELLIPTA and NUBULES are a trade marks of the GlaxoSmithKline Group of Companies. Other~     company or product names mentioned herein may be the property of their respective owners~   "
93359|NCT02345148|"~     The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of~     intranasally administered esketamine in elderly participants (greater than equal to [>=] 75~     years of age) and younger healthy adult participants (18 to 55 years of age, inclusive).~   "
93360|NCT02345135|"~     Death in Ataxia telangiectasia (A-T) is usually due to cancer or chronic lung failure around~     20 years of age. Despite low lymphocyte counts (CD3, CD4, CD8 and CD19), IgA and IgG subclass~     deficiency opportunistic and acute severe respiratory infections are rare. The prevailing~     wisdom is that an immunoglobulin replacement therapy is not necessary in most of the~     patients. However no placebo controlled trials have been performed so far. The aim of this~     trial was to investigate the prevalence of mild and severe respiratory infections and / or~     chronic cough in classical A-T patients compared to healthy controls.~   "
93361|NCT02345122|"~     This four-year research study will evaluate an integrated care model of telephone-based,~     computer-aided care management using a new role of Mental Health Technician and specialized~     software to support primary care providers in providing mental health care. The study will~     compare the effectiveness of this model vs. enhanced usual care in improving initiation of~     specific treatment by the primary care provider, reduction in severity of symptoms, and~     improvement in quality of life or functioning.~   "
93362|NCT02345109|"~     The clinical protocol of the clinical testing of this device:~        1. Objective of the test: To verify the functions and efficiency of devices.~        2. Test methods and procedures: Comparison Test.~        3. Device Under Test (DUT): Transtek Body Fat Analyzer, Model: GBF-835-N2, GBF-835-N2 Plus,~          LS202-B1, LS202-B1 Plus, LS206-E1, LS206-E1 Plus, GBF-1251-B1, and GBF-1251-B1 Plus.~        4. Comparison device: TRANSTEK GBF-1251-B and Tanita BC-533.~        5. Study endpoints: DUT and the comparison device are substantial equivalence.~        6. Statistical methodology used: Description of statistical methods.~   "
93363|NCT02345096|"~     This study aims to evaluate the effect of a specific strain of Saccharomyces cerevisiae on~     improving the effectiveness of conventional treatment of vulvo-vaginal candidiasis. This is a~     randomized, double-blind, placebo-controlled study.~   "
93364|NCT02345083|"~     Frailty is a dynamic process from fit (robust) and pre-frail elderly. There is no previous~     study that determine the risk factors from fit to pre-frailty and pre-frailty to frailty in~     Indonesian elderly.~      This study was aimed to define the risk factors and clinical outcomes of frailty transitional~     status in Indonesian elderly.~   "
93365|NCT02345070|"~     Primary Objective:~      To evaluate, in comparison with placebo, the efficacy of 2 dose levels of SAR156597~     administered subcutaneously during 52 weeks on lung function of patients with Idiopathic~     Pulmonary Fibrosis (IPF).~      Secondary Objectives:~      To evaluate the efficacy of 2 dose levels of SAR156597 compared to placebo on IPF disease~     progression.~      To evaluate the safety of 2 dose levels of SAR156597 compared to placebo in patients with~     IPF.~   "
93366|NCT02345057|"~     This study is a randomized, placebo-controlled, double-blind, multi-center study to evaluate~     efficacy and safety of different doses of CS-3150 compared to placebo in Japanese Type 2~     Diabetes Mellitus and Microalbuminuria.~      The Primary endpoint is the change from baseline in urinary albumin to creatine ratio (UACR).~   "
93367|NCT02345044|"~     This study is a randomized, placebo-controlled, double-blind, multi-center study to evaluate~     efficacy and safety of different doses of CS-3150 compared to placebo in Japanese~     hypertensive subjects. Primary endpoint is change from baseline in sitting systolic and~     diastolic blood pressure.~   "
93368|NCT02345031|"~     This study aims to demonstrate that the investigational drug AUT00063 is effective and safe~     in the treatment of age-related hearing loss.~   "
93369|NCT02345018|"~     The goal of this registry study is to provide insight in the safety and efficacy of treatment~     with MOCA for primary insufficiency of the GSV with a diameter >/=12mm, insufficient~     antero-lateral branches and insufficiency of the GSV below the knee.~   "
93370|NCT02345005|"~     This post market registry consists of a retrospective and a prospective part. The first part~     is a retrospective registry of all implanted IBE devices of Gore in the Netherlands after CE~     mark was obtained, to get an initial insight on the feasibility and safety of this procedure.~     The second part is to prospectively register all data on implanted IBE Gore devices, in order~     to gain more robust data on the efficacy of the device in maintaining hypogastric artery~     patency.~   "
93371|NCT02344992|"~     The addition of BioChaperone to already marketed prandial insulin analogue accelerates the~     onset and shorten the duration of action of insulin lispro due to facilitation of the~     absorption of the insulin after subcutaneous injection.~      This trial is intented to compare the post-prandial blood glucose control of BioChaperone~     insulin lispro and Humalog® when injected after a standardized meal as well as the~     pharmacokinetic profile of BioChaperone insulin lispro and Humalog® in subjects with type 1~     diabetes mellitus.~      This is a double-blinded, randomized, controlled, two-period crossover phase Ib trial to~     compare the blood glucose control after ingestion of a standardized meal, with BioChaperone~     Lispro at 0.2U/Kg and Humalog at 0.2U/Kg.~   "
93372|NCT02344979|"~     Purpose: To evaluate the efficacy and safety of rHuTPO/rHuIL-11 in the treatment for~     chemotherapy-induced thrombocytopenia in patients with NSCLC receiving gemcitabine and~     cisplatin or carboplatin chemotherapy.~   "
93373|NCT02344966|"~     The objective of this study is to evaluate the prognostic factors of acute leukemia patients~     and to invent the molecular genetic test for sensitive detection of minimal residual disease,~     and thereby this study would contribute to plan the risk adapted treatment. Patients will~     have samples of blood and/or bone marrow collected during diagnosis process, treatment and/or~     thereafter~   "
93374|NCT02344953|"~     The objective of this study is to evaluate the prognostic factors of acute leukemia patients~     received stem cell transplantation and to invent the molecular genetic test for sensitive~     detection of minimal residual disease, and thereby this study would contribute to plan the~     risk adapted treatment. Patients will have samples of blood and/or bone marrow collected~     during treatment or thereafter~   "
93375|NCT02344940|"~     To compare the safety of toremifene and tamoxifen therapy in premenopausal patients with~     operable breast cancer by monitoring gynecological abnormality,blood lipid level,hepatic~     abnormality,estrogen level and perimenopausal symptoms.~   "
93376|NCT02344927|"~     It is unclear whether the use of fluids given by a drip is beneficial to cancer patients in~     the last days of life, and as a result many individuals do not receive such treatment~     (although they do receive fluids by mouth, and regular mouth care). The researchers want to~     undertake a large study (main study) to determine the benefits of fluids given by a drip,~     but first need to undertake a small study (feasibility study) to ensure that the main study~     can be done.~      The feasibility study will be done in twelve units (hospitals, hospices) in England & Wales;~     each unit will be allocated a treatment at random, and all patients in the unit will receive~     that treatment (if appropriate). Standard treatment A consists of drinking fluids (if~     possible), regular mouth care, and treatment of any symptoms; standard treatment B consists~     of drinking fluids (if possible) , regular mouth care, fluids by a drip, and treatment of any~     symptoms.~      Patients will be assessed on a four hourly basis, and any uncontrolled symptoms will be~     recorded. The main symptom of interest is agitation (delirium), which has multiple causes,~     including dehydration and kidney failure. Uncontrolled symptoms will be appropriately~     treated, e.g. patients with pain will be given painkillers. Equally, problems relating to the~     fluids given by a drip will also be recorded. Involvement in the study will not interfere~     with the patient's general care, and there will be no additional blood or other tests.~   "
93377|NCT02344914|"~     To assess if the use of the dental support device( DSD) Laboraide™ shortens the second stage~     of labor and decreased the rate of obstetrical interventions, and if it's use alleviate pain.~   "
93378|NCT02344901|"~     The aim of this study is to evaluate the present status of stroke prevention strategies in~     patients with non-valvular atrial fibrillation (NVAF). Vitamin K antagonists (VKAs) have been~     the only available oral anticoagulant therapy for decades. Recently novel oral anticoagulants~     have emerged as an alternative for VKAs. This study is planned to evaluate the~     epidemiological characteristics, thromboembolic and bleeding risks, stroke prevention~     strategies and appropriateness of oral anticoagulant use in NVAF patients. Time in~     therapeutic range (TTR) is going to be calculated as the percent of visits in range (2-3) for~     warfarin patients. This is a national multicenter observational study in which Turkey is~     divided into seven regions. A proportional number of patients to the population of every~     region is planned to be included.~   "
93379|NCT02344888|"~     The purpose of this study is to evaluate the effect of concomitant administration of~     prednisolone during use of clomiphene citrate (CC) for induction of ovulation in infertile~     lean women having CC resistant polycystic ovarian syndrome (PCOS).~   "
93380|NCT02344875|"~     The purpose of this study is to assess the pharmacokinetics, safety and pharmacodynamics~     after single oral administration of FYU-981 to male and female elder subjects in comparison~     with non-elder subjects.~   "
93381|NCT02344862|"~     The purpose of this study is exploratory investigation of safety and efficacy (dose response~     and optimal dose according to the percent reduction from baseline in serum urate level at the~     final visit) of FYU-981 administered orally to hyperuricemic patients with and without gout~     for 8 weeks (dose-escalating initial period: 4 weeks followed by maintenance period: 4 weeks)~     by the method of randomized (dynamic allocation), placebo-controlled, double-blind, parallel~     group comparison.~   "
93382|NCT02344849|"~     This phase I clinical trial is designed to evaluate the safety of autologous Mesenchymal Stem~     Cells (MSC) injected intracavernously.~   "
93383|NCT02344836|"~     Smartphones have the capability to monitor health-related behaviors (exercise, diet, etc.)~     and provide social support which has the potential to play a powerful role in health~     promotion. The objective of this study is to refine and pilot test the Social POD app for~     personalized health monitoring and interaction founded on a combination of social networks,~     recommender systems, motivational research, and health behavior theory. The aim of our~     proposed project is to conduct a 3-month pilot RCT among overweight and obese adults (N=150)~     comparing a theory-based podcast (TBP) plus self-monitoring using a commercially-available~     calorie and weight tracking app (current most popular diet self-monitoring method) versus TBP~     plus self-monitoring and social support/incentive points for participating with the Social~     POD app (TBP+Social POD).~   "
93385|NCT02344810|"~     This partially randomized phase I/II trial studies the side effects and best dose of c-Met~     inhibitor AMG 337 when given together with oxaliplatin, leucovorin calcium, and fluorouracil~     and to see how well they work in treating patients with stomach or esophageal cancer that has~     spread to other places in the body and usually cannot be cured or controlled with treatment.~     C-Met inhibitor AMG 337 may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as, oxaliplatin, leucovorin calcium,~     and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. Giving c-Met~     inhibitor AMG 337 with oxaliplatin, leucovorin calcium, and fluorouracil may kill more tumor~     cells.~   "
93386|NCT02344797|"~     Worldwide, more than 200 million patients have major non-cardiac surgery annually and a~     significant proportion of these patients suffer major cardiovascular complications (e.g.~     nonfatal myocardial infarction, cardiac arrest, vascular death) within 30 days of their~     surgery. Perioperative myocardial infarction is the most common cardiovascular complication~     and recent clinical studies have shown that even minor myocardial injury in relation to~     non-cardiac surgery is associated with 30-day mortality.~      Remote ischemic preconditioning is a procedure, which protects remote tissues and organs e.g.~     against ischemia-reperfusion injury. Cycles of forearm or leg ischemia and reperfusion by the~     inflation of a blood-pressure cuff for brief periods are the preferred method.The aim of this~     interventional clinical study is to determine whether remote ischemic preconditioning can~     reduce markers of myocardial injury in emergent or urgent non-cardiac surgery.~   "
93387|NCT02344784|"~     The purpose of this study is to show that Prepulse inhibition test of acoustic startle~     response is an indicator of objective diagnostic characteristics of attention deficit~     disorder in children and adolescents.~      by demonstrating that Prepulse inhibition test of acoustic startle response is impaired in~     children and adolescents suffering from attention deficit disorder in the relation to the~     normal function described in the literature.~      The investigators will try to prove our hypothesis by an experiment that consists of two~     phases:~      Phase I (about 25 minutes):~      The patient will enter the room, will be asked to sit on a chair, and will be asked to look~     at a computer screen showing silent video of aquarium fish, then the patient will be~     connected to both the Prepulse inhibition test device and the Galvanic skin response device~     and pass the tests.~      Phase II (about 25 minutes):~      After completion of Phase I, each participant will receive his daily regular dose of~     methylphenidate and after an hour and a half from taking the drug, will repeat the tests,~     both the Prepulse inhibition test and the Galvanic skin response test.~      Duration of the entire experiment is 140 minutes (two hours and twenty minutes).~   "
93388|NCT02344771|"~     More than one in 100 otherwise healthy patients undergoing non-cardiac surgery will die~     within 30 days post-operatively, and of these patients 45% will die from vascular causes such~     as myocardial infarction. The pathogenesis of perioperative myocardial infarction is complex~     and to date not fully elucidated. The physiological stress response associated with the~     surgical procedure is believed to be central in the development of perioperative~     cardiovascular complications. Surgery initiates systemic inflammation, hypercoagulability and~     increases the production of catecholamines and cortisol. These drastic systemic changes lead~     to a state of myocardial oxygen supply-demand mismatch, which added to acute endothelial~     dysfunction and ruptures of vulnerable plaques, may result in myocardial injury.~      The endothelium is a regulator of vascular homeostasis, vascular tone and structure and~     exerts anticoagulant, antiplatelet and fibrinolytic properties. Endothelial dysfunction is~     characterized by a decreased vascular bioavailability of nitric oxide probably due to an~     increased degradation of nitric oxide via its interaction with locally produced reactive~     oxygen species. No clinical studies have investigated whether peri- and postoperative~     endothelial dysfunction is associated with an increased risk of perioperative myocardial~     injury. Endothelial dysfunction may be a key element in the development of perioperative~     myocardial injury.~      The aim of this observational clinical study is to closely examine the endothelial function~     and its dynamics in the early postoperative period.~   "
93389|NCT02344758|"~     The purpose of this study is to develope a novel method to determine gluten intake and to~     check gluten-free diet adherence in celiac patients by detection of gluten immunogenic~     peptides in urine.~   "
93390|NCT02344745|"~     Urodynamics are performed in the evaluation of urinary incontinence in women considering~     surgery or who have failed conservative therapies. Urodynamic testing requires the placement~     of small catheters into the bladder and the vagina or rectum. Many women experience anxiety~     around the procedure which can affect patient satisfaction. Lavender aromatherapy has been~     associated with decreased anxiety in a variety of clinical situations. The purpose of this~     study is to determine a difference in self-reported anxiety and pain levels before, during,~     and after multichannel urodynamics in patients given lavender aromatherapy versus placebo.~     This study design is a randomized control trial. Women scheduled for urodynamic testing at~     the Los Angeles County University of Southern California (LAC+USC) Urogynecology clinic will~     be invited to participate. Participants will be randomized to the aromatherapy or the placebo~     group after informed consent is obtained and immediately before undergoing multichannel~     urodynamics. The participants will complete the Hospital Anxiety and Depression Survey (HADS)~     at baseline. They will be asked to rate their level of anxiety and pain before, during, and~     15 min after the study using the visual analogue scale and Wong-Baker pain scale. At the end~     the participants will also be asked to rate their satisfaction with the visit overall. The~     primary endpoint is defined as anxiety immediately after catheters are placed. Data will be~     entered into a coded database for analysis using the independent samples t test, the~     Mann-Whitney U test, and the chi square test. Intention to treat analysis will be used.~   "
93391|NCT02344732|"~     1. To compare the corneal epithelial defect healing time between diabetic patients~          receiving and not receiving supplementary oxygen after vitrectomy.~        2. To determine whether factors such as age, duration of diabetes, duration of surgery and~          level of glycemic control have any influence on corneal epithelial wound healing time in~          diabetic patients receiving and not receiving supplementary oxygen post-vitrectomy.~   "
93392|NCT02344719|"~     The investigators want to analyze the effect of Taurin on portal hemodynamics in patients~     with advanced liver cirrhosis.~   "
93393|NCT02344706|"~     A large proportion of patients (up to 20%) who suffer from an epileptic seizure and remain~     unconscious suffer from a non-convulsive epileptic seizure. The condition is difficult to~     diagnose, and impossible without the required instruments. Electroencephalogram is required~     in the diagnosis of non-convulsive status epilepticus. Presently, the diagnostic value and~     implementation of such a device in the prehospital field is little studied. The aim of this~     study is to evaluate the diagnostic value of the acquired electroencephalogram with a~     prototype EEG/EKG adapter connected to a Physio-Control LifePak 15 defibrillator/monitor. The~     EEG is registered in a otherwise normal fashion with scalp-electrodes, but only three~     channels are monitored, as this is deemed sufficient for the prehospital field, as well as~     for monitoring the epileptic seizures.~   "
93394|NCT02344693|"~     Sudden cardiac death can occur due to a multitude of causes. The underlying case can affect~     the overall prognosis. A return of spontaneous circulation not exceeding 30 minutes following~     a successful cardiopulmonary resuscitation is usually deemed imperative, if the patient is to~     survive. Monitors for evaluating the cardiac function during and after resuscitation are~     implemented on a daily basis (ekg, pulseoxymetry, blood pressure monitoring, cardiac~     sonography), but no devices for registration of the cortical brain activity exist. The aim of~     this study is to provide a 3-channel electroencephalogram using a prototype EEG/EKG adapter,~     connected to a Physio-Control LifePak 15 monitor/defibrillator, in patients who regain~     spontaneous circulation following non-traumatic cardiac arrest.~   "
93395|NCT02344680|"~     In this study the investigators will determine risk factors for liver fibrosis among HIV-HBV~     co-infected patients in Lusaka, Zambia, and assess the long-term effectiveness of~     antiretroviral drugs in the prevention and/or reduction of liver disease.~   "
93396|NCT02344667|"~     Recent studies support the use of Stereotactic Body Radiation Therapy (SBRT) for the~     treatment of localized prostate cancer (PrCa). SBRT is a way to deliver radiation very~     precisely allowing higher doses to be delivered with fewer treatments, potentially improving~     patient outcomes. Cyberknife and Volume Modulated Arc Therapy (VMAT) are accepted SBRT~     techniques. However, the effects of the specific SBRT treatment technique on patient outcomes~     have not been evaluated in randomized trials.~      Although such a trial would be of great interest, patients' willingness to participate is~     unclear. Multiple patient and clinician factors contribute to the decision to enter a~     randomized trial. This feasibility study will evaluate patients' willingness to participate~     in a trial comparing Cyberknife and VMAT SBRT for the treatment of early stage PrCa. Patients~     accepting enrolment will be randomized to one of the two types of SBRT delivery. Up to 66~     patients will be approached, and up to 40 randomized. A questionnaire will help to identify~     the factors influencing the patient's decision to participate or not. This study will gather~     information on feasibility, PSA control, patient outcomes and side effects, and will inform~     the design of a future randomized phase II/III study.~   "
93397|NCT02344654|"~     The primary objective is to compare the success rates of intraoperative fluorescent~     cholangiography using indocyanine green versus conventional X-ray cholangiography for the~     identification of bile duct anatomy during laparoscopic cholecystectomy for complicated~     gallstone disease in a randomized design with 120 patients.~   "
93398|NCT02344641|"~     The study evaluates the efficacy of heart function improvements in type 2 diabetes and heart~     failure patients with exenatide, and also investigates the mechanisms of exenatide improving~     heart function.~   "
93399|NCT02344628|"~     The study will be a single blinded, randomized, controlled open label non-inferiority phase~     III, trial with two parallel groups, conducted in Ghana and Papua New Guinea (PNG). The~     ultimate goal is to establish if a 20mg/kg dose of azithromycin is as effective as a 30mg/kg~     dose in the treatment of yaws. Approximately 600 clinically and serologically diagnosed yaws~     patients will be included in the study. Patients will be randomized to receive treatment with~     the two antibiotic regimens as follow: (i) Regimen I (AZT20): Single oral dose of 20 mg/kg~     azithromycin (ii) Regimen II (AZT30): Single oral dose of 30 mg/kg azithromycin. The~     follow-up period of patients will be 6 months. Assessments before, during and after the~     antibiotic treatment will include full medical history, clinical assessment of the lesion~     and, laboratory investigations. The primary efficacy parameters are healing of the lesion at~     4 weeks and a four-fold decline in RPR titre at 6 months after start of treatment.~   "
93400|NCT02344615|"~     The investigators compared the postoperative analgesia of nerve stimulator-guided and~     ultrasound-guided infraclavicular block for upper extremity surgery.~   "
93401|NCT02344602|"~     Patients with type 1 diabetes mellitus (T1DM) are at high risk of developing kidney~     complications potentially leading to end stage renal disease. Uric acid (UA), the end product~     of purine metabolism, emerged as an important determinant of renal and vascular injury due to~     its ability activate the renin-angiotensin-aldosterone system (RAAS) and increase production~     of harmful reactive oxygen species (ROS). ROS cause progressive endothelial cell dysfunction,~     inflammation, tissue fibrosis and eventually cell death. These processes are enhanced in DM~     because of the effect of hyperglycemia.~      Since existing preventive drug therapies fail to completely prevent kidney damage, an~     examination of the effect of UA lowering against initiation and progression of renal and~     vascular complications is therefore of the utmost importance. The purpose of this study is to~     examine the effect of UA lowering with febuxostat on renal and systemic vascular function in~     patients with uncomplicated T1DM. It was hypothesized that UA lowering will improve kidney~     and systemic vascular function through effects on blood vessel function and anti-inflammatory~     effect.~      Kidney and blood vessel function will be assessed under conditions of normal and high blood~     sugar levels before and after 8 weeks of treatment with the UA lowering drug febuxostat in~     patients with diabetes and during normoglycemia only in health controls.~      Current treatment for renal and vascular complications in DM patients includes blockade of~     the RAAS. Unfortunately, angiotensin converting enzyme inhibitors (ACEi) and angiotensin II~     (AngII) receptor blockers (ARBs) lead to incomplete RAAS suppression, and do not completely~     prevent renal or vascular complications. Moreover, dual RAAS blockade increases renal and~     cardiovascular risk. Recent experimental work suggests that UA lowering therapies can block~     the RAAS, suppress inflammation and promote renal and systemic vascular protection.~     Therefore, our study is critical in determining the possible role of early UA lowering on~     renal and systemic hemodynamic dysfunction in young patients with T1DM.~   "
93402|NCT02344589|"~     Our aim is to investigate which components of the quadriceps femoris muscle are affected~     following an ACB with different volumes (10, 20 and 30 ml) of 1% lignocaine evaluated by~     electromyography. Both a placebo treatment (20ml saline) and the femoral nerve block (20ml~     lignocaine 1%) as an active comparative will be used for model control. Further, we want to~     investigate the effect of volume on motor block. This will be evaluated by measuring the~     Maximum Voluntary Isometric Contraction (MVIC) of the quadriceps femoris muscle.~   "
93472|NCT02343653|"~     The purpose is to investigate the effect of strength training on muscle strength, muscle mass~     and nutritional status in patients with liver cirrhosis to clarify possible metabolic and~     inflammatory changes during this intervention. In addition the investigator examine if the~     intervention is associated with fewer hospital readmission and an improved quality of life.~   "
93403|NCT02344576|"~     The left ventricular assist device (LVAD) is growing rapidly among people dying from~     end-stage heart failure who are unable to get a heart transplant. These patients elect to~     live out the remainder of their lives dependent on a partial artificial heart—so-called~     destination therapy (DT). Although patients may live longer with a DT LVAD, it poses many~     risks, including stroke, serious infection, and bleeding. Most of these patients have other~     medical problems that are not fixed by the DT LVAD. Patients must be connected to electricity~     at all times. A caregiver is required, which often places stress on loved ones. Therefore,~     the decision whether or not to get a DT LVAD is often an extremely difficult one.~     Unfortunately, our research shows problems with the way this medical decision is currently~     being made in hospitals across the United States. Hospitals that offer DT LVAD treatment do~     not follow a standard process. The forms, pamphlets, websites, and videos used to help~     patients and families are biased and too difficult for most people to understand. Lastly,~     this is an emotional and even scary decision for most patients and their families, but the~     process does not help them deal with these feelings.~      Using feedback from patients, caregivers, clinicians, the study team made a paper and video~     decision aid to help people who are offered DT LVAD make this most difficult of decisions.~     Unlike the information that is now available, our decision aid focuses on options, fears, and~     the needs of caregivers, is balanced, and is paired with training for doctors and nurses on~     how to best talk about DT LVAD. The investigators now propose to test the effectiveness and~     implementation of this intervention. The investigators will apply the Reach, Effectiveness,~     Adoption, Implementation, Maintenance (RE-AIM) evaluative framework to a stepped-wedge,~     cluster-randomized, controlled trial across 6 medical centers.~      Aim 1. Evaluate the Reach and Effectiveness of the DT LVAD shared decision support~     intervention to improve patient and caregiver experiences.~      Hypothesis 1a: The intervention will reach 90% of eligible patients. Hypothesis 1b:~     Post-implementation, patients and caregivers will have improved decision quality (greater~     knowledge and higher value-treatment concordance).~      Aim 2. Assess the Adoption, Implementation, and Maintenance of the DT LVAD shared decision~     support intervention across multiple providers and settings.~      Hypothesis 2: The intervention will be: adopted by key personnel; implemented consistently;~     and maintained after trial completion.~   "
93404|NCT02344563|"~     A randomized, single-dose, two-way crossover study to evaluate bioequivalence of two~     formulations of meropenem (meropenem intravenous injection 0.5 g) after intravenous infusion~     in healthy volunteers.~   "
93405|NCT02344550|"~     The purpose of this study is to evaluate the efficacy of addition of everolimus to letrozole~     with LHRH agonist in premenopausal metastatic breast cancer patients who failed to tamoxifen~     treatment.~   "
93406|NCT02344537|"~     The investigators wish to conduct a preliminary study to examine the efficacy of meditation~     among patients with Post Treatment Lyme Syndrome (PTLDS). Specifically, the investigators~     will use the breathing, meditation, and stretching techniques common to Kundalini Yoga~     practice. The investigators plan to assess the degree in which this practice can reduce~     Post-Treatment Lyme Disease symptoms. Because fatigue and pain are so common among patients~     with PTLDS, the primary focus of this study will be fatigue and pain. Secondary outcomes will~     include cognitive complaints, physical and mental functioning, medical utilization, somatic~     symptoms, and psychopathology.~   "
93407|NCT02344524|"~     The purpose of this trial is to study the role of small bore chest drains in draining~     traumatic hemothorax and pneumothorax.~   "
93408|NCT02344511|"~     Dalbavancin for Pediatric Osteomyelitis~   "
93409|NCT02344498|"~     Viral hepatitis kills nearly one million people each year, even though effective treatment~     exists. The aim of this study is to establish a treatment protocol for hepatitis B, which is~     simple and cheap enough to be implemented in resource-limited settings.~   "
93410|NCT02344485|"~     The aim of this pilot study is to investigate the effect of Osteopathic Manipulative Medicine~     (OMM) in decreasing constipation symptoms in people with Parkinson's disease (PD). A second~     but optional aim is to determine if OMM changes the bacterial flora of the mouth and gut. OMM~     is a safe and gentle manual treatment provided by osteopathic physicians. All participants~     will receive OMM during the second half of the eleven week trial.~   "
93411|NCT02344472|"~     A multicenter, randomized phase III study to compare chemo- versus endocrine therapy in~     combination with dual HER2-targeted therapy of Herceptin® (trastuzumab) and Perjeta®~     (pertuzumab) in patients with HER2 positive and hormone-receptor positive metastatic breast~     cancer.~   "
93412|NCT02344459|"~     The purpose of this study is to perform a randomized controlled trial to compare the efficacy~     of 80mL double balloon catheter versus a 30mL single catheter balloon for pre-induction~     cervical ripening by evaluating the change in Bishop score.~   "
93413|NCT02344446|"~     The purpose of this study is to investigate if skilled physical therapy treatment for~     dizziness after sports-related concussion, delivered after greater than 30 days~     post-concussion is effective to remediate physical symptoms. This will be the first study~     that explores differential PT treatment for dizziness in concussed athletes who have physical~     symptoms 30+ days after concussion. The findings of this important research have great~     potential to influence clinical practice and place increased emphasis on and acceptance of~     manual skills and neuromotor training in the treatment of concussed patients with dizziness.~   "
93414|NCT02344433|"~     A Relational Agent (RA) virtual counselor (VICKY: VIrtual Counselor for Knowing Your Family~     History) has been developed to collect family health history information for common health~     conditions including heart disease, stroke, diabetes, hypertension and various cancers. In~     this study, the investigators will conduct a randomized controlled trial (RCT) to compare the~     efficacy of using VICKY to the existing My Family Health Portrait (MFHP) tool for collecting~     family health history information among an underserved primary care patient population. The~     primary aims of the study are to 1) evaluate the efficacy of VICKY versus MFHP for collecting~     accurate family health histories and 2) determine whether accuracy varies as a function of~     health literacy. This project will obtain validation data on the efficacy of both VICKY and~     MFHP for collecting accurate family history data among an underserved patient population, in~     two languages (English and Spanish). The study will determine whether a virtual counselor can~     overcome many of the existing barriers to using traditional web-based family history tools.~   "
93415|NCT02344420|"~     BIOWOMEN is a study designed to compare the Cardiac Resynchronization Therapy (CRT) response~     rate in a Heart Failure (HF) population with an equal distribution of men and women.~     Different clinical variables will be collected (QRSd, Left Bundle Brunch Block (LBBB), HF~     etiology…) and compared in order to demonstrate that women may respond even better than men.~   "
93436|NCT02344134|"~     The purpose of this study is to describe the immunogenicity and safety of the cell~     culture-derived influenza vaccine compared with the egg-derived influenza vaccine among~     subjects.~      To describe the immunogenicity, antibody levels are evaluated by hemagglutination~     inhibition(HI) assay from sera obtained pre-vaccination and 21 days post-vaccination.~      To describe the safety, the time of onset and duration of local and systemic solicited~     adverse events are assessed and reported. Unsolicited adverse events and serious adverse~     events are collected and categorized throughout the study period.~   "
93416|NCT02344407|"~     Background:~      - Ebola virus disease (EVD) affects many people in Liberia and other countries in West~     Africa. It is caused by the Ebola virus and makes people sick with fever, headache, vomiting,~     diarrhea, rash, and bleeding. About half the people with EVD die. There is no approved~     treatment for it. Researchers are studying two Ebola vaccines. The vaccines do not cause~     Ebola.~      Objectives:~      - To study the safety and efficacy of two Ebola vaccines.~      Eligibility:~      - Adults 18 and older who live in Liberia and are at risk for Ebola infection but have never~     had Ebola.~      Design:~        -  Participants will give information including birthdate, gender, occupation, and location~          of home. They will give contact information for themselves and 2 alternate contacts.~          They will give a history of their contact with people with Ebola. Some participants may~          have a physical. They may have blood taken.~        -  Participants will be injected with either an Ebola vaccine or a placebo with a needle in~          the upper arm. The placebo is a salt solution.~        -  Participants will have blood taken.~        -  Participants will be watched for 30 minutes.~        -  Participants will return to the clinic 1 week and 1 month after they get the shot. They~          will have blood taken.~        -  After that, participants will be contacted monthly to discuss how they are feeling. They~          may be contacted by phone, may visit the clinic, or may have a home visit.~        -  The study ends 8-12 months after participants get the shot. If one of the vaccines works~          against Ebola and does not have many side effects, participants can get the vaccine if~          they did not get it in the study.~   "
93417|NCT02344394|"~     The overall objective of the study is to compare and assess the clinical outcomes of the~     standard of care hybrid ablation using epicardial ablation in conjunction with endocardial~     PVI alone versus epicardial ablation in conjunction with endocardial ablation using PVI with~     additional RF ablation in a randomized, prospective population of patients with persistent AF~     of at least 6 months duration. All devices that are used are being utilized under the~     approved labeling of the devices.~   "
93418|NCT02344381|"~     Carbohydrate is stored in the body as glycogen, which is mainly found in the liver and~     muscle. During endurance exercise, muscle glycogen is used as fuel for the working muscles~     and liver glycogen is broken down to provide glucose to maintain blood glucose (sugar)~     levels. Both liver and muscle glycogen are important for our ability to perform~     intense/prolonged endurance exercise. Therefore, it is important to replete these stores~     after an intense/prolonged endurance exercise session in order to recover and perform~     optimally during a subsequent exercise bout, especially if the next exercise session is~     within 24h (e.g. stage races such as the Tour de France, tournament-style competitions such~     as the Olympic games and ultra-endurance events).~      Carbohydrate intake has been shown to increase the availability of glycogen in the muscle and~     liver after exercise. The carbohydrates typically found in sports drinks are glucose and~     sometimes fructose. It has been observed that the ingestion of glucose will lead to a maximum~     rate of absorption of approximately ~1 g/min. However, if we also provide a different source~     of carbohydrate (fructose) then this is absorbed through a different pathway and therefore we~     can absorb up to ~1.75 g/min of carbohydrate. In addition, both carbohydrate sources are~     metabolised differently in the human body. By supplementing both glucose and fructose, we can~     potentially replenish the liver and muscle glycogen stores at a faster rate than ingestion of~     glucose only.~      Sucrose is a naturally occurring sugar that is made up of a single glucose and single~     fructose molecule. Therefore, theoretically, this can use the two different pathways of~     absorption and also maximise carbohydrate delivery. It is not yet known however, what impact~     this has on our liver and muscle glycogen stores post-exercise when supplemented in~     relatively high amounts. Therefore the aim of this study is to assess whether relative high~     amounts of sucrose ingestion will improve liver and muscle glycogen repletion after endurance~     exercise.~   "
93419|NCT02344368|"~     Despite the fact that oral sucrose is the most frequently studied non-pharmacological~     intervention for procedural pain relief in infants, there is a paucity of data on the minimal~     effective dose. The aim of this study is to find the minimal effective dose of sucrose to~     reduce pain during a single venous blood sampling procedure.~   "
93420|NCT02344355|"~     This clinical trial evaluates adding high-dose ascorbate (vitamin C) to standard of care~     treatment of glioblastoma multiforme (a type of brain tumor) in adults. All subjects will~     receive high-dose ascorbate in addition to the standard treatment.~   "
93421|NCT02344342|"~     The proposed project is a 2x2 factorial designed study aimed at assessing the impact of 1) a~     home tele-monitoring system and 2) a flexible diuretic regimen among high risk heart failure~     patients in the University of Michigan Health System (UMHS).~   "
93422|NCT02344329|"~     A Comparison of AmnioExcel® and Total Contact Casting (TCC-EZ) Versus Standard Wound Care and~     TCC-EZ in Treating Diabetic Foot Ulcers Best practice is to treat DFUs with standardized care~     and, if unsuccessful, use advanced modalities. This prospective clinical trial will compare~     healing rates between two treatment modalities in patients with DFUs in an ambulatory wound~     care clinic. The treatments are Total Contact Cast (TCC-EZ) with AmnioExcel® and TCC-EZ with~     standard treatment.~      Adult participants 18 years or older with a diabetic foot ulcer located on the plantar~     surface and >1 cm in diameter will be asked by the Altru Wound Care Clinic MD or Family Nurse~     Practitioner visit to participate in the study if they have not demonstrated a 50% in~     reduction in wound area after two weeks of standard treatment. For those potential subjects~     who do not have 3rd party reimbursement the cost of the product and application will be~     covered by the respective company. They must be cognitively intact as evaluated by wound~     clinic primary care providers. Participants must agree to use the study treatments as~     directed, and to keep clinic visits during the 12-week trial or until the ulcer closes,~     whichever comes first.~   "
93423|NCT02344316|"~     Migraine in adolescents is common and effective and safe preventive treatments are needed.~     This is a pilot randomized controlled trial of melatonin versus placebo for migraine~     prevention in adolescents 12-17 years old.~   "
93424|NCT02344303|"~     Assess the electrocardiogram effects of TRV130 relative to placebo at therapeutic and~     supratherapeutic doses.~   "
93425|NCT02344290|"~     The study is funded by the National Heart, Lung, and Blood Institute, with additional~     infrastructure support provided by the National Institute of Allergy and Infectious Diseases.~      People infected with HIV are at risk for cardiovascular disease (CVD). This study will~     evaluate the use of pitavastatin to reduce the risk of CVD in adults infected with HIV who~     are on antiretroviral therapy (ART).~   "
93437|NCT02344121|"~     Analysis to quantify intra-fraction, inter-fraction and post-treatment changes in tumor~     target volumes and surrounding normal organs in radiation therapy.~   "
93452|NCT02343926|"~     Primary Objective:~      To compare the clinical efficacy of gemigliptin and vildagliptin as add-on therapy to~     metformin in terms of change in Hemoglobin A1c (HbA1c) reduction.~      Secondary Objectives:~      To compare the safety and tolerability of gemigliptin and vildagliptin:~        -  Number of patients who experience at least one episode of hypoglycemia.~        -  Number of patients experiencing adverse event (AE), serious adverse event (SAE).~        -  Assessment of patients compliance defined as number tablets returned by patients.~   "
93426|NCT02344277|"~     Brugada syndrome is an inherited arrhythmia syndrome with an increased risk of syncope and~     sudden death resulting from episodes of polymorphic ventricular tachychardia and~     fibrillation. Currently, there is no medical therapy for the Brugada syndrome and the only~     treatment available is the implantation of an ICD. There is no discussion on the interest of~     the ICD implantation in secondary prevention and in patients who experienced syncope but the~     best therapeutic is more difficult to draw in asymptomatic patients. Recently we demonstrated~     that in asymptomatic patients with a spontaneous type 1 aspect of Brugada syndrome, (i) there~     was a significant risk of ventricular arrhythmia, (ii) the problem of inappropriate shocks~     can be solve with a good ICD programming and (iii) the problem of lead failure remains the~     main problem in this young population very active and represent the main limitation to larger~     indication of ICD implantation in this population with a very long life expectancy as these~     patients had a normal life expectancy except the risk of ventricular arrhythmia.~      In this context the S-ICD System (Boston Scientific Inc.) which is an implantable~     defibrillator technology that treats ventricular tachyarrhythmias using a subcutaneous pulse~     generator and electrode system rather than a transvenous lead system, represents a very~     attractive opportunity as it gives the possibility to protect the patients of the risk of~     ventricular arrhythmia with no risk of lead failure. However, as this is a new technology and~     as Brugada syndrome patients are a very specific population (very active patients, specific~     and changing over time ECG aspect that is at risk of T wave over sensing and high risk of~     SVT), it seems important to evaluate the effectiveness and the safety of S-ICD in this~     specific context.~   "
93427|NCT02344264|"~     The patients will be included the 1. or 2. day after surgery. All THA patients will be~     screened. Those reporting VAS > 40 during active 30 degrees hip flexion will be asked to~     participate.~      Included patients will receive 2xNCFL (singleshot) first placebo (8 ml saline) and then~     ropivacaine (8 ml ropivacaine 7,5mg/ml) or the other way around (randomized). There will be~     45 minutes between the two blockades. The blockades will be ultrasound guided.~   "
93428|NCT02344251|"~     In pharmacotherapy trials involving drug-dependent individuals, medication compliance is a~     significant issue, as rates tend to be low and adherence to medication may predict improved~     outcomes (Baros et al, 2007; McRae et al, 2004; O'Brien et al, 1996; Somoza et al., 2010).~     However, methods commonly used to determine compliance may result in inaccurate measurement~     of adherence. In this study, we propose to assess the effectiveness and safety of the ID-Cap~     System, a novel compliance measurement device, in a healthy population.~   "
93429|NCT02344238|"~     In pharmacotherapy trials in drug-dependent populations, medication compliance is a~     significant issue, as rates tend to be low and adherence to medication may predict improved~     outcomes (Baros et al, 2007; McRae et al, 2004; O'Brien et al, 1996; Somoza et al., 2010).~     However, methods commonly used to determine compliance may result in inaccurate measurement~     of adherence. It is therefore essential to develop measurement systems that not only~     accurately and objectively measure compliance, but can also have the potential to increase~     compliance in difficult to treat disorders such as addiction. In this study, we propose to~     assess the acceptability, tolerability, and efficacy of the ID-Cap, a novel compliance~     measurement device, in a healthy population.~   "
93430|NCT02344225|"~     Phase 2, open-label, randomized, multi-center studies in infants and premature infants are~     necessary to determine treatment and preventative strategies for ROP. This study was designed~     to: a) target infants at the highest risk of ROP in a large number of centers with variable~     rates of ROP (all stages and severe ROP or stage 3+); and b) assess whether caffeine plus~     systemic or ophthalmic NSAID will decrease ROP among infants most at risk for ROP. The study~     is designed to determine whether the novel treatment regimens are safe and potentially~     effective for ROP prevention and to obtain requisite data for the development of a Phase III~     efficacy/safety randomized blinded trial. Since caffeine is used extensively in NICUs as~     standard of care for ELGANs, no placebo group is included.~   "
93431|NCT02344212|"~     The long-term objective of this study protocol is to develop and test a culturally sensitive,~     community-based intervention, ESENCIAL Para Vivir (Essential for Life) to promote weight loss~     and diabetes prevention among overweight or obese Latina immigrants. We chose to focus on~     Latinas because Latinas are at especially high risk for developing diabetes and currently~     there are not Spanish programs available in our area that provide education about weight~     management and diabetes prevention.~   "
93432|NCT02344199|"~     Beta-blockers should be administered to all patients with heart failure stage II to IV~     according to NYHA.Beta-blockers reduce mortality and hospitalizations and improve the~     operational phase for all categories of patients with heart failure. Since beta-blockers,~     only carvedilol, metoprolol, bisoprolol and recently nevimpololi have shown these benefits~     and so, only they have evidence to be provided.~      Eplerenone is indicated, in addition to conventional therapy, for reducing the risk of~     cardiovascular mortality and morbidity in stable patients with left ventricular dysfunction~     (LVEF ≤ 40%) and clinically proven heart failure after recent myocardial infarction.~   "
93433|NCT02344186|"~     The main objective of the study will be to test the hypothesis that treatment with~     Liraglutide will decrease ER stress and adipose tissue in obese patients with type 2~     diabetes. Experimental Approach: The investigators will use a prospective, single blind,~     placebo controlled study design to study 12 obese patients with type 2 diabetes mellitus~     (T2DM). 6 patients will first receive Liraglutide for 24 weeks followed by placebo for 12~     weeks. The other 6 patients will first receive placebo for 12 weeks followed by Liraglutide~     for 24 weeks.~      Measurements: The investigators will determine glycemic control (with HbA1c), body~     composition (bioelectric impedance analysis), insulin sensitivity (with~     hyperinsulinemic-euglycemic clamps), insulin secretion (with oral glucose tolerance testing),~     energy balance (calories in vs. calories out), plasma lipid levels and obtain subcutaneous~     fat biopsies to determine ER stress response markers before and after placebo and before and~     after Liraglutide treatment.~   "
93434|NCT02344173|"~     The purpose of this registry is to assess the performance and clinical effectiveness of a~     combination of SJM mapping and ablation products in the treatment of subjects with atrial~     fibrillation (AF).~   "
93435|NCT02344160|"~     The objective of the study is to demonstrate non-inferiority of stem revision rate in~     subjects implanted with the REDAPT™ System with a revision rate of less than 9.8% at the 5~     year mark assuming an observed rate of 6.5% at 5 years. Additional data will be collected as~     outcomes of safety and effectiveness data up to 10 years post REDAPT revision surgery.~   "
93438|NCT02344108|"~     Obstructive sleep apnea (OSA) affects up to 1% of the general pediatric population and is~     associated with adverse behavior and quality of life, as well as long term cardiopulmonary~     system complications. Trisomy 21 (Down Syndrome) is the most common chromosomal disorder,~     with a incidence of approximately 1 per 660-800 births. Patients with Down Syndrome have a~     higher incidence of OSA than the general pediatric population, with rates of 30-60%,~     resulting in increased morbidity and decreased quality of life for affected individuals. In~     children, adenotonsillectomy (T&A) is often a contributing factor to OSA, and~     adenotonsillectomy is a first line treatment. Children with Down Syndrome often undergo T&A~     for obstructive sleep apnea, however 30-50% will have persistent obstructive sleep patterns~     requiring continuous positive pressure airway support (CPAP) or tracheotomy. Persistent~     obstruction is attributed to anatomic and physiologic differences in this population,~     including reduced muscular tone, macroglossia, maxillary hypoplasia, and lingual tonsil~     hypertrophy. This pilot study is designed to determine if the Inspire® Upper Airway~     Simulation System, Model 3024 IPG, and any subsequent iteration thereof that are approved~     under P130008 for the treatment of obstructive sleep apnea, which has already been approved~     for use in adults with OSA, can be safely implanted and used in adolescents and young adults~     with Down Syndrome.~   "
93439|NCT02344095|"~     The investigators aimed to evaluate the safety of weekly paclitaxel with oncothermia and~     weekly cisplatin with oncothermia in patients with recurrent or persistent epithelial~     ovarian, fallopian tube or primary peritoneal carcinoma. This trial is a randomized phase 1~     trial. The investigators planned to perform it for 1 year. In this trial, a total of 12~     patients with recurrent or persistent epithelial ovarian, fallopian tube or primary~     peritoneal carcinoma are randomly assigned to either a paclitaxel or cisplatin group in ratio~     of 1 to 1. Paclitaxel group are treated with weekly paclitaxel and oncothermia. Cisplatin~     group are treated with weekly cisplatin and oncothermia. In each group, limiting toxicity is~     evaluated after treating 3 patients for 4-cycles. Primary endpoint is occurrence of limiting~     toxicity. Secondary endpoints are response rate, progression-free survival, overall-survival,~     quality of life, pain, fatigue and compliance rate.~   "
93440|NCT02344082|"~     This prospective study will include both an intervention and control arm. The control arm~     will receive face-to-face pharmacy clinic visits per standard of care. The intervention arm~     will receive pharmacy clinic visits plus additional telephone follow-up. Patients with a~     hemoglobin A1c in the last 3 months greater than 9% will be eligible. Eligible patients must~     have a primary care physician at Johns Hopkins Outpatient Center (JHOC) or East Baltimore~     Medical Center (EBMC).~      Purpose: To compare the change in hemoglobin A1c over the 3 month study period in the~     intervention group in which patients participate in telemedicine, to a control group in which~     they do not~   "
93441|NCT02344069|"~     Effect of immediate, pre-emptive fibrinogen concentrate in patients with trauma haemorrhage~     needing haemostatic resuscitation - a randomized, controlled, double-blinded~     investigator-initiated pilot trial~   "
93442|NCT02344056|"~     The Cognition Intervention Study Dortmund (CogniDo) and the Cognition Intervention Study~     Dortmund PLUS (CogniDo PLUS) investigated the short-term effects of having school lunch~     versus skipping it on children's basal (CogniDo) and executive (CogniDo PLUS) cognitive~     functions in the afternoon. The present Coco study connect this two previous studies and~     investigates the effect of having school lunch versus skipping it on children's basal and~     executive cognitive functions later in the afternoon.~   "
93443|NCT02344043|"~     Purpose of the Study Critical illness requiring life support affects over 150 000 people in~     Ontario every year. With aggressive support, the number of people who die from critical~     illness is decreasing. However, people who survive often have neurological problems. These~     neurological problems often include difficulties with memory, concentration, and attention.~     These problems are associated with poor quality of life among survivors of critical illness.~     The aim of this study is to identify the factors that contribute to these neurological~     deficits. Specifically, the investigators are testing whether changes in oxygen delivery to~     the brain during critical illness are related to both short- and long-term neurological~     complications.~      Procedures involved in the Research When patients are diagnosed with a critical illness such~     as shock or respiratory failure, they are treated with intravenous fluids, medications to~     raise their blood pressure, and can be placed on a ventilator to assist with their breathing.~     They are observed in an intensive care unit (ICU). This research protocol does NOT interfere~     with the normal treatment of patients with critical illness. The procedure involved in this~     research protocol requires the placement of two stickers to either side of the patient's~     forehead, and information about oxygen delivery to the brain will be recorded. When the~     patient has recovered from the critical illness, they will be asked to perform several~     neurological tests. Some of these tests will be done with a pencil and paper, while others~     will use a robotic device to test arm movements, reaction time, and concentration.~      Potential Harms, Risks or Discomforts:~      This research study involves the placement of a sticker sensor to either side of the~     forehead. Rarely, patients may develop a rash to these electrodes. The investigators monitor~     patients very carefully for rashes, and if a rash is to occur, the sticker sensor will be~     removed. With regards to the neurological testing, rarely patients can have some mild muscle~     stiffness after moving their arms in the robot. The investigators do not expect any other~     further harms, risks, or discomforts.~   "
93444|NCT02344030|"~     Comparison of intubation time from the time to fix the Trachealtube to the first end-tidal~     CO2 ventilation by means of the curve on the ventilator at KV standard blade and KV channeled~     blade~   "
93445|NCT02344017|"~     The purpose of this first-in-man study is to evaluate safety, tolerability and~     pharmacokinetics of ODM-204 in patients with metastatic castration-resistant prostate cancer.~   "
93446|NCT02344004|"~     A study to evaluate the effectiveness of Liposomal Amikacin for Inhalation (LAI) when added~     to multi-drug regimen in subjects with Nontuberculous Mycobacterial (NTM) lung infection~     caused by Mycobacterium Avium Complex (MAC).~   "
93447|NCT02343991|"~     The purpose of this study is to evaluate the safety of BBB disruption using transcranial~     MRI-guided focused ultrasound in conjunction with an intravenous ultrasound contrast agent to~     increase the accumulation of doxorubicin in brain tumours and the adjacent brain using the~     ExAblate Transcranial system (220 kHz). Data will be collected to establish the basic safety~     of this type of treatment as the basis for later studies to evaluate its clinical efficacy.~   "
93448|NCT02343978|"~     The purpose of this study is to evaluate the safety and efficacy of KWA-0711 in Chronic~     Constipation (CC) patients.~   "
93449|NCT02343965|"~     Each year, 17000 cases of severe hematological diseases are diagnosed in France, with more~     than 6,000 of these requiring hospitalization in a protective, sterile environment. New~     methods, such as touch massage, have emerged in response to anxiety symptoms observed in~     patients in such sterile and isolated surroundings. We hypothesize that during the period of~     isolation, touch massage becomes a nursing care which can help the patient.~   "
93453|NCT02343913|"~     This study is an additional component of protocol 6005, titled Simplifying Menstrual~     Regulation (MR): Exploring the role of at-home semi-quantitative pregnancy tests for~     follow-up to menstrual regulation service provision in Pakistan. The study seeks to pilot a~     self-assessment checklist that will help women, who receive medical services for incomplete~     abortion, correctly identify warning signs and symptoms and determine whether to return to~     the clinic. The checklist can serve as a useful resource to help with the timely~     identification of women who need additional care and can help streamline service delivery. In~     addition, this study will provide important data on the role of misoprostol at varying levels~     of health services offering an array of treatments for incomplete abortion.~   "
93454|NCT02343887|"~     Despite undetectable plasma viral load under treatment, about 30% of HIV infected patients~     show asymptomatic neurocognitive impairment or minor cognitive disorder. These symptoms~     impact the compliance of the treatment, though its performance and daily life quality. To~     this day, no therapy tested has proved its efficiency, including the strategy of the~     antiretroviral therapy (cART) optimization according to the Cerebral Penetration~     effectiveness Score (CPE).~      Description of the study: an open prospective comparative monocentric pilote study,~     randomised in three groups which investigates the efficiency of a 6 months-cognitive~     rehabilitation program on improving asymptomatic or minor cognitive disorder for undetectable~     HIV+ patients. This study gathers HIV-1 patients undetectable under stable cART with a good~     cerebral penetration who develop asymptomatic or minor cognitive disorders connected to HIV~     infection. Those who have severe psychiatric disorder or who are on medication that could~     interfere with psychometrical tests will be excluded.~      Main Objective: to compare the impact of a cognitive rehabilitation program over a 6 months~     period on the evolution of minor cognitive disorders and asymptomatic patients to a control~     group and a group treated with psychological support.~   "
93455|NCT02343874|"~     The prevalence of alcohol-related disorders in the general population is around 10%. The~     relationship between the use of healthcare services, costs and the amount of alcohol consumed~     by the general population is unknown. Because alcoholism is a major public health problem, it~     is significant to determine the prevalence of consumption of primary users and the~     relationship between the dose of alcohol and health care costs. This information may allow~     the implementation of preventive strategies to reduce consumption with the aim to reduce~     morbidity and healthcare expenditure.~      A cross-sectional study will be carried out. Patients over 17 years old, treated at primary~     healthcare centers in Catalonia that have available data on alcohol consumption from January~     2010 to December 2012 will be included. Clinical and sociodemographic data will be collected.~     Health service use and health care costs from 2013 will be collected from SIDIAP (The~     Information System for the Development of Research in Primary Care) database.~      A positive relationship between grams of alcohol consumed per week and the use of resources~     and health expenditure will be expected and also the level of risk of alcohol consumption.~     There will be a descriptive analysis of the clinical data and sociodemographic variables. A~     multivariate analysis will be done to see the relationship between alcohol consumption and~     health care costs and health care service utilization.~   "
93456|NCT02343861|"~     Atopic dermatitis is the most common chronic inflammatory skin disease in children and~     severely affects quality of life (QoL) of patients and their parents. The application of~     topical medications and emollient is the mainstay of the treatment, but complexity of the~     treatment and lack of self-care knowledge cause poor adherence, leading to therapeutic~     failure. Adequate education about the chronic disease and its treatment was known to improve~     the treatment adherence. There are a variety forms like generalized information leaflets and~     video clips for imparting information to patients and individualized tailoring education was~     considered more effective way to improve patients' adherence. The aim of this study is to~     determine the efficacy of tailored education in dermatology area, especially the emollient~     usage in patients with atopic dermatitis.~   "
93457|NCT02343848|"~     The association between physical activity and several complication of pregnancy will be~     evaluated .~   "
93458|NCT02343835|"~     This protocol will study the impact of Irreversible electroporation (IRE) on immune response~     in patients diagnosed with unresectable pancreatic cancers smaller than 5.0 cm. It will~     profile the immune response to IRE of unresectable pancreatic cancers. The intra-tumoral and~     systemic immune response to IRE will be determined and compared to pre-ablated pancreatic~     cancer specimens and historical control specimens.~   "
93459|NCT02343822|"~     To determine the ideal dose of PRP for lateral epicondylitis. To see if 2 PRP injections are~     better than a single PRP injection or a saline injection to improve function and pain in~     patients with lateral epicondylitis.~   "
93460|NCT02343809|"~     Diacutaneous Fibrolysis (DF) is a manual method of treatment, usually adjuvant, addressed to~     the mechanical pain of the locomotor system. In our clinical practice a favorable effect is~     observed in patients with chronic lateral epicondylitis, but there are no published studies~     evaluating the results of this technique.~      The objective of this trial is to evaluate if DF provides a further improvement in pain~     intensity, pain-pressure threshold, function and pain-free grip strength, in patients with~     chronic lateral epicondylitis being treated with physiotherapy. For this purpose, we conduct~     a randomized controlled trial, double-blind (patient and evaluator) in a Public Primary Care~     Center.~      Sixty subjects will be randomized (computer application) into three groups: Intervention~     Group, Placebo Group and Control Group. All the three groups receive the same protocolized~     treatment of physiotherapy and additionally. Additionally, the Intervention Group receives~     six sessions (two sessions in a week during three weeks) of real DF and the Placebo Group~     receives six sessions (two sessions in a week during three weeks) of sham DF. The Control~     Group receives the protocolized treatment of physiotherapy only.~      Pain intensity (VAS), pain-pressure threshold (pressure algometry), function (DASH~     questionnaire) and pain-free grip strength (digital dynamometer) will be measured at~     baseline, after treatment period, and three months after discharge from treatment. After~     discharge for treatment the patient subjective opinion about their evolution will be~     collected through the Global Rating of Change (GROC) scale.~   "
93461|NCT02343796|"~     The purpose of this study is to determine whether fibre-reinforced composite resin~     restorations are effective for single tooth replacement, elimination of tooth mobility~     following periodontal treatment and as an orthodontic retainer.~   "
93462|NCT02343783|"~     The purpose of this study is to characterize the cell (the basic building block of all living~     things) populations and inflammatory (pain and swelling) mediator responses in suction skin~     blister fluid after allergic skin reaction (ASR) [rash] induction with D. Pteronyssinus~     [house dust mite (HDM)], Alternaria alternata, or Aspergillus fumigatus allergens in~     participants with atopic dermatitis (AD) [Skin rash, Eczema] or allergic asthma (AA)~     [breathing disorder in which there is a wheezing and difficulty breathing].~   "
93463|NCT02343770|"~     Juvenile idiopathic arthritis (JIA) is the most common form of arthritis in children. The~     etiology is unknown. Several types of arthritis fall under the JIA heading. Oligoarticular~     JIA with antinuclear antibodies affects about half of all children. There 's no specific~     markers. Our purpose is to identify new markers in this pathology. The ProtoArray®Human~     Protein Microarray allows rapid and efficient detection of protein interaction using a~     suitable protein or small molecule probe. The investigators hope so detect novel potential~     autoantigen biomarkers specific in JIA.~   "
93464|NCT02343757|"~     The early detection of a preclinical AD or early stage of AD with amyloid imaging could~     improve the diagnosis and provide knowledge for better therapeutical approach by combining~     the best of imaging: structural MR sequences and newly FDA-approved biomarker for amyloid PET~     imaging, all these two techniques with their strengths in one machine.~      Specific Aims and Hypotheses can be summarized as follows:~        1. To assess image quality and diagnostic performance of 18F-florbetapir (AMYVID) PET/MRI,~          including direct comparison to corresponding PET/CT images of the same patients.~        2. To evaluate the incremental value of using 18F-florbetapir (AMYVID) in addition to~          2-[F-18]-fluoro-2 deoxy-D-glucose (FDG) versus FDG alone. Does quantification of plaque~          burden correlate with degree of neuronal degeneration as depicted by FDG as well as with~          clinical severity?~        3. To determine plaque burden quantitatively with 18F-florbetapir (AMYVID) in PET (form~          PET/CT and from PET/MR) using novel software developed specifically for these brain~          application; Computer-Aid Diagnosis for Dementia for amyloid imaging - CAD4D-amyloid~   "
93465|NCT02343744|"~     The purpose of this study is to examine descriptively the efficacy of CNTO 1959 in~     participants with generalized pustular psoriasis (GPP) or erythrodermic psoriasis (EP).~   "
93466|NCT02343731|"~     Studies show that family members share as much or more of the composition of their microbiota~     (the trillions of micro-organisms in our guts) with their dogs as they do with each other~     (Song et. al. 2013). This shows that the introduction of dogs into home environments has a~     profound impact on the human microbiota. Additionally, many studies show that children raised~     with dogs are less likely than others to develop a range of immune-mediated disorders,~     including asthma and allergies (Ownby, Johnson, and Peterson 2002; Almqvist et al. 2003;~     Havstad et al. 2011). This suggests that dogs can serve as probiotics for children by~     appropriately training their immune systems not to produce inflammation in response to~     harmless stimuli. What is not known, however, is whether the same is true for elderly~     populations and dogs. Thus, this study seeks to explore whether dogs might also improve the~     physical and mental health of elderly adults by improving the structure and function of their~     microbiota. The investigators propose a pilot/proof of concept study to investigate whether~     dogs might improve the physical and mental health of elderly adults via changing (improving)~     the structure and function of their microbiota (gut flora). The investigators propose a~     pre-post study design that among 20 elderly individuals (aged 50 and older) to investigate~     the probiotic effect that dogs might have on these individuals. The investigators are~     particularly interested to know whether introducing a dog into a home where one has not lived~     in the recent past increases the positive microorganisms in the guts of the humans living~     with them. The investigators will also measure the changes in markers of inflammation (from~     blood samples) as well as the changes in self-reported scores of depression, frailty,~     physical activity, and general health and well-being mobility among human participants. In~     order to assess any effects in the animal study participants, the investigators will also~     collect and analyze fecal and blood samples as well as conduct home visits to observe canine~     and human interactions and bonding and conduct assessments of canine well-being using~     questionnaires/observational techniques that have been validated for these purposes in other~     studies. Additionally, the investigators will assess the interactions between of the~     participants with the dog and how having a dog in the home may influence an individual's~     relationship with the dog and his/her thoughts about the microbiota, human and canine health~     and human-animal interactions through monthly semi-structured interviews.~      The investigators have previously received IACUC approval for this study, approval number~     14-537.~   "
93467|NCT02343718|"~     The purpose of this study is to determine the best dose of vinblastine that can be given with~     a new drug, temsirolimus.~   "
93468|NCT02343705|"~     The objective of the Latella-2 study is to demonstrate the safety and efficacy of the Latella~     Knee Implant System for the reduction of medial osteoarthritis knee pain.~   "
93469|NCT02343692|"~     Up to 13.5% of patients that undergo a magnetic resonance imaging (MRI) scan of their abdomen~     without pancreatic symptoms are found to have an incidental pancreatic cyst, with the~     frequency increasing with age. In a post-mortem series, 25% of patients had a pancreatic~     cyst, of which 32% were potentially premalignant and 3% malignant. Premalignant cysts are~     currently either observed or removed surgically according to international guidelines.~     Observation is associated with significant anxiety for patients and a growing cost to the~     National Health Service, while surgery for this usually benign condition is associated with~     not insignificant morbidity and mortality. Premalignant pancreatic cysts may be indolent for~     a number of years before malignant transformation, creating a window of opportunity for~     minimally invasive intervention and cure. New early treatment options for premalignant~     tumours are urgently required. This study will evaluate the safety and efficacy of a novel~     minimally invasive technique for the treatment of pancreatic cystic tumours; endoscopic~     ultrasound guided radiofrequency ablation (EUSRFA).~      If successful it will offer an alternative to long term observation or surgery for patients~     with this condition.~   "
93470|NCT02343679|"~     This is a phase II, single arm, unblinded study of ceritinib in patients with rel/ref~     hematologic malignancies. Up to 24 evaluable subjects will be enrolled with an interim~     analysis for efficacy after the first 9 subjects are enrolled. Any subject who takes at least~     one dose of study drug will be evaluable for safety. Only subjects who complete at least 1~     cycle of study drug and have clear progression on physical exam or have had at least one~     restaging study will be considered evaluable for response. Each subject will receive the same~     dose of 750mg po daily at the study entry. Subjects with stable disease or better will be~     allowed to continue study drug until disease progression or until intolerable adverse events~     or patient or physician decision. Intrapatient dose reductions will be allowed for adverse~     events. This is a multicenter study with Duke as the lead site. Blood and tissue samples,~     will be collected and used for exploratory analysis.~   "
93471|NCT02343666|"~     This pilot phase I trial studies the side effects and best dose of human immunodeficiency~     virus (HIV)-resistant gene modified stem cells in treating HIV-positive patients who are~     undergoing first-line treatment for Hodgkin or Non-Hodgkin Lymphoma. Stem cells are collected~     from the patient and HIV-resistance genes are placed into the stem cells. The stem cells are~     then re-infused into the patient. These genetically modified stem cells may help the body~     make cells that are resistant to HIV infection.~   "
93475|NCT02343614|"~     The treatment of non-muscle invasive bladder cancer (NMIBC) is problematic given the variable~     natural history of the disease. Although contemporary treatment options are limited, new~     targets and new approaches are under investigation for preventing bladder cancer recurrence~     and progression. Among those, COX-2 is a promising target since plays an important role in~     urothelial carcinogenesis and iCOX-2 selective inhibitors, like celecoxib, effectively~     inhibit tumor development and growth and enhances survival, in bladder cancer in vitro and in~     vivo models.~      Therefore, the investigators conducted a pilot study of celecoxib to prevent recurrence in~     patients with intermediate risk NMIBC.~   "
93476|NCT02343601|"~     The purpose of this study is to determine whether hemodynamic optimization with~     photoplethysmography (ClearSight, Edwards Lifesciences, Irvine, CA) during colorectal surgery~     could decrease the incidence of perioperative complications.~   "
93477|NCT02343588|"~     The study was designed as a national multi-centered cluster randomized controlled trial~     involving more than 70,000 children and adolescents aged 7-18 years from 7 provinces in~     China. In each center, about 12-16 primary and secondary schools, with totally at least 10000~     participants were randomly selected (Primary: Secondary=1:1). All of the selected schools~     were randomly allocated to either intervention or control group (Intervention:~     Control=1:1).The multi-components school-based and family-involved scheme was conducted~     within the intervention group for 9 month, while students in the control group followed their~     usual health practice. The intervention consisted of four components: a) Create supportive~     school and family environment, b) Health lifestyles education and related compulsory physical~     activities, c) Instruct and promote school physical education, d) Self-monitor obesity~     related behaviors. Four types of outcomes including anthropometric, behavioral, blood~     chemical and physical fitness were measured to assess the effectiveness of the intervention~     program.~   "
93478|NCT02343575|"~     Delirium is the most often encountered psychiatric diagnosis in the general hospital, with~     incidence up to 85% in the intensive care unit (ICU) setting and with significant~     consequences on patients' morbidity and mortality. Currently, although not FDA approved,~     antipsychotics are often considered the first-line pharmacological treatment. However, there~     can be limitations to their use, including side effects or lack of efficacy. Valproic acid~     (VPA) is one of the alternatives at times used in such patients which from limited case~     series data appears to be helpful and tolerated. VPA can provide relief from agitation that~     poses a threat to the safety and recovery of the patient. Moreover, mechanistically it~     addresses the neurochemical and cellular abnormalities inherent in delirium (it has~     NMDA-antagonist, anti-dopaminergic, GABAergic,anti-inflammatory, anti-apoptotic, and histone~     deacetylase inhibitor properties, among others). The purpose of this study is to evaluate the~     efficacy and tolerability of the VPA in the first known to us randomized controlled trial.~   "
93479|NCT02343562|"~     Hirschsprungs Associated Enterocolitis (HAEC) with incidence up to 30% postoperatively. The~     objective of the trial is to prevent postoperative HAEC by using Probiotics.~   "
93480|NCT02343549|"~     All patients will complete best standard of care radiation, temozolomide and bevacizumab (6~     weeks). Within two weeks of completion of this initial treatment period, study patients will~     be fitted with the NovoTTF-100A System and treated continuously. They will be treated with~     TTFields for 12 months for an average of 18 hours per day. The patient may elect to take a~     treatment break for a total of 3 days per month, for each month and still be in compliance.~     This will consist of wearing four electrically insulated electrode arrays on the head. The~     patients will also continue with maintenance temozolomide/ bevacizumab.~   "
93481|NCT02343536|"~     The goal of the study is to identify a dose and schedule of CC-486 that can be safely~     administered with R-CHOP. To evaluate the safety and maximum tolerated dose (MTD) or the~     maximal administered dose (MAD) of CC-486 in combination with rituximab, cyclophosphamide,~     doxorubicin, vincristine, and prednisone (R-CHOP) in subjects with high risk (IPI 2 or more)~     previously untreated DLBCL or Grade 3B FL.~      Also, to determine pharmacokinetics (PK) of CC-486 when administered alone and in combination~     with R-CHOP and to explore preliminary efficacy of CC-486 plus R-CHOP by 2007 International~     Working Group (IWG) criteria.~   "
93482|NCT02343523|"~     The present study proposes to utilize a novel, wearable device, QI Device, which has multiple~     sensors embedded in a wrist-watch in order to explore its monitoring capabilities in~     individuals with congestive heart failure.~   "
93483|NCT02343510|"~     PCR for chlamydia DNA is done in paraffin blocks of cases of primary tubal cancer and is~     compared to cases of high grade serous ovarian cancer and normal tubes .~   "
93484|NCT02343497|"~     The purpose of this study is to investigate whether astaxanthin supplementation can impact~     triglyceride plasmatic concentrations in volunteers presenting mild dyslipidemia.~   "
93485|NCT02343484|"~     Many different minimally invasive techniques have been used for the treatment of chronic~     discogenic low back pain refractory to conservative treatments, with various results. The aim~     of this study is to assess the efficacy of the combination of intradiscal pulsed~     radiofrequency and gelified ethanol versus gelified ethanol alone, on pain and quality of~     life of patients sufferring from chronic discogenic low back pain.~   "
93495|NCT02343354|"~     Women with gestational diabetes (GDM) have increased risk of developing type 2 diabetes;~     their children show more insulin resistance and diabetes compared to offspring of mother~     without diabetes in pregnancy. An increased diabetes risk is also observed among partner of~     adult with prediabetes/type 2 diabetes. The investigators have pilot-tested a program for~     diabetes risk reduction among women within 5 years of a GDM pregnancy (MoMM program). The~     investigators are now enhancing the program to engage directly the partner (MoMMii program).~      In MoMMii, 66 couples with a history GDM in the mother will participate in a multimodal~     diabetes prevention program that includes healthy meal preparation training, discussion of~     eating and physical activity behaviours and developing home environments that facilitate~     healthy habits, pedometer-based step count monitoring, and participation in family-based~     activities (frisbee, soccer) as well as individual exercise (e.g., use of exercise equipment,~     floor resistance exercises). Participants will be encouraged to communicate between sessions~     with study personnel and with one another to create a between family support network. All~     mothers and fathers will participate in five sessions over six months. The investigators will~     examine changes in health-related behaviours, blood pressure, glucose levels, and insulin~     sensitivity/resistance in both mothers and fathers.~   "
93486|NCT02343471|"~     Cardiovascular disease (CVD) is one of the most important and frequent causes of death.~     Postprandial lipidemia (PPL) is an independent risk factor for CVD, besides the traditional~     risk factors e.g. hypertension, high LDL-cholesterol, family disposition of CVD and type 2~     diabetes (T2D). A high PPL is associated with an increased risk of myocardial infarction and~     stroke. Reduction of increased PPL, as a part of CVD prevention, is therefore pivotal.~     Especially in groups with increased risk of CVD, like the metabolic syndrome (MeS) and T2D.~     Identification of a simple diet-related method will possibly result in reduction of CVD in~     healthy as well as high-risk subjects.~      The aim of this project is to investigate the effect whey protein consumed as pre-meal prior~     to a fat-rich meal on responses of triglycerides and apolipoprotein B48 (ApoB48) in subjects~     with type 2 diabetes compared to healthy subjects. Secondarily the aim is to study the~     responses of glucose, insulin, glucagon, amino acids, inflammatory markers, incretins, rate~     of gastric emptying and metabolomics. Also satiety feeling will be measured.~      Investigators hypothesize that whey protein consumed 15 minutes prior to a fat-rich~     isocaloric meal reduces triglyceride- and ApoB48 responses more in type 2 diabetic subjects~     compared to healthy subjects.~      The investigators research will hopefully contribute to a better understanding of how PPL can~     be modified in a simple manner. It will promote innovation to the food industry for~     development and production of healthy food products, which can be applied in the fight~     against CVD in the background population in general and high-risk people in particular. Thus,~     the results of this project can impart knowledge of great importance both to the national and~     international food industry as well as the healthcare systems.~   "
93487|NCT02343458|"~     A chronic dosing (24 weeks) study to assess the efficacy and safety GFF MDI; PT003), FF MDI;~     PT005, and GP MDI; PT001) in subjects with moderate to very severe COPD, compared with~     placebo.~   "
93488|NCT02343445|"~     The goal of the study is to evaluate the safety and tolerability of P-1037 and to determine~     whether the combination of P-1037 with hypertonic saline or P-1037 alone has a greater effect~     on lung function in patients with CF than placebo (0.17% saline).~   "
93489|NCT02343432|"~     This study was aimed to investigate the impact of using different epidural volumes.~      Patients with acute discogenic pain were included in the study.~   "
93490|NCT02343419|"~     The aim of the study is to compare standard spirometric evaluation of methacholine challenge~     test with plethysmographic, interrupter technique and forced oscillation technique (FOT)~     evaluation of the airways resistance.~      The study group will consist of patients referred for methacholine challenge test. All~     patient will undergo spirometric, plethysmographic, interrupter technique and FOT~     examinations - before and after inhalation of aerosols. Patients will also undergo the~     measurement of nitric oxide concentration in exhaled air and laboratory tests, including:~     blood count, measurement of serum C-reactive protein, sodium, potassium, creatinine,~     immunoglobulin E and N-Terminal pro-brain natriuretic peptide (NT-proBNP) concentration.~      The investigators intend to assess, if plethysmographic, and/or interrupter, and/or FOT~     measurement of bronchial reactivity can replace standard spirometric assessment.~     Plethysmography, interrupter technique and FOT are much more easier to perform for patients.~     Furthermore, those two techniques are less dependent on patient's motivation and cooperation~     ability. Thus, usage of FOT, interrupter technique and/or plethysmography in bronchial~     hyperreactivity testing could make methacholine challenge test more comfortable and available~     for more patients. The investigators are also going to analyze the relationship between~     exhaled nitric oxide and functional indices of bronchial hyperreactivity.~   "
93491|NCT02343406|"~     This study is to evaluate the efficacy and safety of ABT-414 alone or with temozolomide~     versus temozolomide or lomustine alone in participants with recurrent glioblastoma~     multiforme.~      The study includes a Pediatric sub-study to evaluate safety, tolerability and~     pharmacokinetics of ABT-414 in a pediatric population.~      Adult enrollment has been completed and the study is now only recruiting for pediatric~     participants.~   "
93492|NCT02343393|"~     This is a single-blind, randomised, clinical trial assessing the efficacy of Hydralazine and~     Isosorbidedinitrate combination (oral agents) in HF patients with renal dysfunction.~   "
93493|NCT02343380|"~     The investigators aim at analyzing whether eating a standard meal in the evening (at 8:00 pm)~     determines in the same individuals a lower diet-induced thermogenesis (DIT) and a different~     hormonal response than the consumption of the same meal in the morning (at 8:00 am).~      The primary outcome is: the intra-individual variation in DIT after the evening and morning~     meal consumption.~      The secondary outcomes are the intra-individual variations in glucose, triglyceride, insulin,~     free fatty acids, leptin, glucagon-like peptide-1, acylated ghrelin, adrenalin, noradrenalin,~     after the evening and morning meal consumption.~   "
93494|NCT02343367|"~     The H4K Trial is a randomized controlled trial to improve children's body composition by~     testing a comprehensive, culturally and linguistically relevant, family-oriented intervention~     for overweight and obese Hispanic children (ages 6-11) in three pediatric clinics in San~     Antonio, Texas. The H4K trial will test the efficacy of a 6-month pediatric obesity~     management intervention (physician counseling plus telephone counseling, newsletters and text~     messages) compared to standard care (physician counseling only) on three outcomes: 1) body~     composition (i.e., waist circumference, weight and z-BMI); 2) insulin, glucose and~     cholesterol levels; and 3) behavior change in physical activity (PA), sedentary behavior and~     consumption of sugary beverages and fruits and vegetables. The investigators will recruit 230~     overweight and obese children—and a parent or guardian for each—and randomize them to the H4K~     intervention (n = 115 child/parent dyads) or standard care (n = 115 child/parent dyads). The~     investigators hypothesize that intervention children will significantly improve their body~     composition, increased their PA levels and diet quality (more fruits and vegetables and less~     sugary beverages), and decrease their sedentary activity, compared to children in standard~     care. If successful, this study will generate new scientific knowledge about effective~     Hispanic family-based approaches for obesity prevention with high potential for replication~     in underserved areas across the nation.~   "
93517|NCT02343055|"~     The overall objective of this study is to evaluate a collaborative self-management~     intervention in patients with moderate to severe COPD in a primary care population. To~     achieve this objective the investigators developed a diagnostic and treatment pathway for the~     management of COPD in primary care that is based on national guidelines and focused on~     patient self-management.~   "
93496|NCT02343341|"~     Project 1. Primordial/primary behavior change in children~      Problem: Childhood obesity has more than doubled over the past 30 years, with nearly~     one-third of children aged 6 to 11 years being obese. These children are more likely to~     become obese adults and are at a higher risk for the development of diabetes, hypertension,~     heart disease and cancer.~      Approach: This research tests the hypothesis that habits are formed very early in life and~     that children can help their parents live healthier lives. The investigators attempt to test~     this hypothesis by evaluating the impact of an educational program focusing on diet, physical~     activity, knowledge of the human body, and management of emotions for preschool children aged~     3 to 5 years, their parents/caregivers and teachers. The investigators will first assess the~     environmental factors, facilitators, and barriers to implementation of a health promotion~     educational program tailored for preschoolers in Harlem, New York. This information will be~     used to tailor the educational program for the children in Harlem. The investigators will~     evaluate the effectiveness of the program in children aged 3 to 5 years by randomly assigning~     blocks of schools to an up to 5-month educational and playful health promotion intervention~     or to usual curriculum. The program will also have components for teachers and parents of~     these children in order to make their learning environment conducive to positive change. The~     impact of our program will be assessed on children's knowledge, attitudes, habits, weight,~     exercise and diet using simple questionnaires and measurements.~      Impact: The investigators expect to demonstrate a positive impact on knowledge, attitudes and~     habits in preschool children in an under-served population. Also aim is to demonstrate that~     this early educational program can increase the proportion of preschool aged children with~     normal weight. This approach has the potential to meaningfully modify the projected rise in~     obesity and cardiovascular disease by affecting an entire generation of children. The~     investigators believe that the healthy habits that the children will acquire through this~     program will lead them to be healthier adults. Thus, the mission aligns closely with the~     American Heart Association's mission of, Building healthier lives, free of cardiovascular~     diseases and stroke.~   "
93497|NCT02343328|"~     The investigators wish to compare Fecal Microbiota Transplant (FMT) capsules to placebo~     capsules in subjects with TWO episodes of C. difficile. The investigators have numerous~     subjects and physicians requesting FMT at the time of a second relapse, in order to prevent~     further hospitalizations, obtain a faster and more durable cure, avoid costly medications~     like fidaxomicin and oral vancomycin, and fix the underlying dysbiosis. In some instances,~     subjects feel like they are being asked to get sick again before they can pursue the most~     effective option. The investigators propose to study these subjects with a rigorous placebo~     controlled design, which will contribute significantly to our understanding of the utility of~     FMT, timing, and the real relapse rates in a tertiary referral center. Subjects who relapse~     with placebo will by definition have a third episode, meet consensus criteria for FMT, and~     will be offered standard FMT by capsule at that time. Additionally, this study will allow~     us to further capture safety data, in comparison to placebo capsules and further enhance our~     understanding of the microbiology of dysbiosis, earlier on in the illness course. Lastly, the~     investigators may decide to perform a cost analysis.~   "
93498|NCT02343315|"~     The purpose of this study is to compare the added effects of TENS and Supervised Motor~     Control Exercises (SMCE) over Unsupervised Home Exercise Program (UHEP) on disability, pain~     and other outcomes.~   "
93499|NCT02343302|"~     A very common complication following distal pancreatectomy is leakage from the pancreas, or~     what is called a pancreatic fistula. We hypothesize that operative drains which create~     suction may contribute to the development of leakage from the pancreas. This study evaluates~     the effect of using non-suctioning drains to prevent the development of this complication.~   "
93500|NCT02343289|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of~     esketamine administered by the intranasal (administered through the nose) and oral routes and~     to evaluate the effects of clarithromycin on the pharmacokinetics of intranasally~     administered esketamine.~   "
93501|NCT02343276|"~     Single-center study, randomized, double-blind, placebo controlled, with patients undergoing~     diagnostic or therapeutic catheterization via the transradial approach. Patients will be~     randomized into two groups: one group will receive the vasodilator nitroglycerin during the~     procedure (intervention group), and a second group will receive saline 0.9% in the same~     volume and time during the procedure (control group).~      Will be evaluated: incidence of spasms of the radial artery, ability to perform the procedure~     without the need to change the access site, pain presented by the patient, time and total~     radiation of the procedure.~   "
93502|NCT02343263|"~     The purpose of this study is to evaluate the effect of combining two interventions already in~     use at some institutions for reducing post-operative pain following tonsillectomy or~     adenotonsillectomy. The standard of care at most institutions is to leave the tonsillectomy~     wound bed exposed to heal on its own over one to two weeks. At many institutions, surgeons~     inject or topically apply local anesthetics such as bupivacaine hydrochloride to the~     tonsillectomy wound bed to help reduce post-operative pain. At other institutions, surgeons~     apply a layer of fibrin sealant, which is derived from the proteins that help form blood~     clots in blood, to the tonsillectomy wound bed in order to cover the site and reduce~     irritation and exposure of the wound bed. Use of fibrin sealant has the additional benefit of~     potentially reducing postoperative bleeding (hemorrhage) rates. Both the post-tonsillectomy~     use of bupivacaine (injection and topical) and the use of topical fibrin sealant application~     have been studied previously in the scientific literature; some studies show a clear benefit,~     others show no significant reduction in pain when they are used. No studies have documented~     harm. The purpose of this study is to evaluate the efficacy of infusing bupivacaine~     anesthetic into the fibrin sealant prior to application to the tonsillectomy wound bed. In~     this way, the combined product would function as a sort of medicated bandaid covering the~     painful wound bed and slowly delivering an entirely safe total dose of bupivacaine into the~     wound bed to reduce post-operative pain. Parents will be provided post-operative pain~     measurements to complete during the first 10 postoperative days and return to the researchers~     for data analysis.~   "
93503|NCT02343250|"~     A Randomized, Open-label, Single Dosing, Two-way Crossover Clinical Trial to Compare the~     Safety/Tolerability and Pharmacokinetics of the Combination of Cilnidipine 10mg and Valsartan~     160mg in Comparison to Each Component Coadministered in Healthy Male Volunteers~   "
93504|NCT02343237|"~     The purpose of this study is to evaluate the analgesic effects of a 6 weeks osteopathic~     treatment on patients with fibromyalgia.~   "
93505|NCT02343224|"~     This is a phase II study of the drug, pegylated interferon alfa-2b (PEG-IntronTM), used to~     treat brain tumors in a pediatric population. Researchers want to see if treatment with~     PEG-IntronTM will stop tumor growth for patients with juvenile pilocytic astrocytomas or~     optic pathway gliomas.~      The purposes of this study are:~        -  To learn more about the response to pegylated interferon~        -  To learn more about the side effects of pegylated interferon~        -  To learn more about MRI images in patients with Juvenile Pilocytic Astrocytomas or Optic~          Pathway Gliomas.~        -  To learn more about quality of life in patients treated with pegylated interferon~   "
93506|NCT02343211|"~     Paraneoplastic Neurological Syndromes (PNS) are rare remote effects of cancer, not directly~     attributed to mass lesions, metastases, infections, ischemia, coagulopathy, metabolic~     disruptions or tumour treatment. Currently, PNS treatment is mostly limited to tumour~     treatment. Because of an initial inflammatory stage early in the evolution of the PNS several~     immunotherapy modalities have been tried. Intravenous human immunoglobulins could be expected~     to provide a stabilization or even improvement of PNS, if administered early enough to~     prevent permanent neuronal damage.~   "
93507|NCT02343198|"~     The use of neuromuscular electrical stimulation (NMES) as a home-based therapy following~     total knee arthroplasty. Measures of interest: lower limb venous hemodynamics, joint range of~     motion, lower limb swelling, walking speed, quality of life, activities of daily living,~     device usability, device compliance, activity levels, and pain (VAS).~   "
93508|NCT02343185|"~     This study is a double-blind randomized clinical trial with two arms which aims to study the~     effects of diaphragmatic treatment in patients with nonspecific low back pain.~      Low back pain has a great importance in today's society, and it is therefore important to~     develop an effective treatment for this condition. People with chronic nonspecific low back~     pain, can present respiratory disorders and get anxiety states, affecting mainly the~     diaphragm muscle. Therefore, given its direct anatomic relationship, the diaphragm may be~     part of the development of chronic low back pain. Although clinical practice guidelines for~     chronic low back pain have been developed, it hasn't been explored before a physiotherapy~     treatment especially aimed at a diaphragmatic treatment.~      A double-blind randomized clinical trial with two arms will be used for this purpose, 64~     patients with nonspecific low back pain referred from different hospitals of Castellón will~     be randomized into two groups:~        -  Diaphragmatic intervention with osteopathic manual therapy treatment (D).~        -  Diaphragmatic intervention with placebo treatment group (P).~      An osteopathic manual therapy protocol for the treatment of back pain including techniques~     for the diaphragm muscle will be applied to the patients in group D, in a total of 5~     sessions. For patients in group P, the same protocol will be performed on the diaphragm but~     with placebo treatment techniques.~      The study focuses on the analysis of the following variables: scores on the questionnaires:~        -  Pain: McGill Pain Questionnaire and VAS (Visual Analogical Scale ).~        -  Fear Avoidance: (FABQ)~        -  Disability: Oswestry Disability Index and Roland-Morris~        -  Anxiety: HADS: (Hospital Anxiety and Depression Scale)~        -  Catastropizing: PCS (Pain Catastropizing Scale)~        -  Satisfaction with treatment (Escala de Satisfacción con el tratamiento)~      The results of these pre-intervention and post-intervention variables will be compared~     between the two groups in the first session, in the fourth session and in the first and third~     month after the first intervention. The VAS score will also be assessed in the second and~     third session.~   "
93509|NCT02343172|"~     To determine the MTD/RP2D of the HDM201 and LEE011 combination and evaluate whether the~     combination is safe and has beneficial effects in patients with liposarcoma.~   "
93510|NCT02343159|"~     The primary objective of the study is to determine whether a Medication Event Monitoring~     System (MEMS®) cap with a liquid crystal display (LCD) reader (a smart cap) along with~     additional patient counseling intervention (Arm 3) can improve adherence to dimethyl fumarate~     (DMF) treatment in Multiple Sclerosis (MS) patients as compared to a MEMS cap without an LCD~     reader (a standard cap) and no patient counseling intervention (standard of care, Arm 1) at~     Month 12.~      The secondary objectives of this study in this study population are: to determine if data~     display on a smart MEMS cap with an LCD reader (Arm 2) can improve adherence as compared to a~     standard MEMS cap without an LCD reader (Arm 1) at Month 12; to determine whether the~     addition of patient counseling intervention based on MEMS data (Arm 3), or data display from~     a MEMS cap with an LCD reader (Arm 2) can improve adherence compared to standard MEMS cap~     without an LCD reader (Arm 1) at Month 6; to assess persistence and compliance at Months 6~     and 12 for all arms; to assess the association between adherence and patient- reported~     outcomes (PROs) for all arms including Multiple Sclerosis Impact Scale (MSIS-29), and the~     Work Productivity and Activity Impairment Questionnaire (WPAI): MS v2.0.~   "
93511|NCT02343146|"~     The incidence of type 1 diabetes (T1D) in young children (age <5 years) is rising. The burden~     of responsibility for disease management rests on parents and caregivers to check blood~     sugar, administer insulin, and monitor diet and physical activity to maintain tight glycemic~     control. This occurs at a vulnerable time in life when children's behavior is unpredictable,~     their T1D is difficult to control, and parenting stress is elevated. Despite behavioral~     interventions that have demonstrated success in reducing rates of parent stress and improving~     child behavior, improvements in young children's glycemic control has not been sufficiently~     achieved. The investigators' research will attempt to achieve this goal through the~     development and pilot of an innovative behavioral intervention for T1D in parents of young~     children. The focus of the intervention is on improving young children's nutrition and~     physical activity through the use of parent consultants and delivery of intervention through~     phone and text messaging. The study will be conducted in two phases. In Phase 1, 10 primary~     caregivers of young children (<5 years) diagnosed with T1D for at least 6 months will receive~     the intervention and then be assessed at 3- and 6- months post baseline on indices of~     behavior and glycemic control (including continuous glucose monitoring). Participants will~     also complete in-depth surveys to provide qualitative as well as quantitative data. At the~     end of Phase 1, the data will be analyzed and used to develop the intervention further for~     Phase 2. During Phase 2, 60 participants and their children will be randomized to either the~     revised intervention (treatment) or usual care (control) condition. Intervention components~     include: T1D management support delivered by trained lay parent consultants, and T1D~     parenting strategies specific to improving eating and physical activity behaviors delivered~     by bachelor's level behavioral assistants via telephone and text messaging. Biomedical and~     psychosocial measurements (including HbA1c, physical activity, nutrition, mealtime behavior,~     parenting stress, quality of life) will occur at baseline and 3- and 6-months post baseline.~     The results of this work will ultimately lead to a program which can improve young children's~     T1D management and glycemic control that can be translated into a variety of clinical~     practice settings.~   "
93512|NCT02343133|"~     The purpose of this study is to determine whether HemaMax is safe and well tolerated to~     support efficacy under FDA's Animal Rule to reduce the morbidity and mortality associated~     with the hematopoietic syndrome of acute radiation syndrome.~   "
93513|NCT02343120|"~     This study will evaluate the safety, tolerability, pharmacokinetic profile and treatment~     effect of a new drug known as BGB-3111 in patients with B-Cell Lymphoid Malignancies.~   "
93514|NCT02343107|"~     Abdominal obesity and its metabolic consequences, particularly type 2 diabetes, require~     personalized nutritional monitoring. Today, it is not always possible to provide patients~     with appropriate care to both, the diet plan, physical activity, stress and sleep management.~     Emerging data have shown the effectiveness of remote support (e- coaching), in order to~     increase the level of physical activity and reducing calorie intake which causes weight loss~     similar to that obtained during a face to face consultation. Compared to a food survey~     conducted by a dietician, the dietary survey MXS computer software showed similar results on~     the collection of nutritional data. Furthermore, users preferred this method of remote~     collection compared to direct interview. The investigators recently developed a tool for~     e-coaching combining this computerized dietary survey and education and support modules on~     diet and physical activity (MXS- health program) for the patients. The aim of the~     investigators' study is to compare efficacy of this new software vs usual care.~   "
93515|NCT02343094|"~     The purpose of this study is to determine whether sodium phenylbutyrate can reduce Lcn2~     urinary expression in proteinuric patients.~   "
93516|NCT02343081|"~     The purpose of this crossover, single-dose, bioequivalence study is to compare the rate and~     extent of absorption of Temozolomide after the administration of the study product~     (Dralitem®, Monte Verde S.A.) and the reference product (Temodal®, Schering Plough) in~     primary Central Nervous System patients.~   "
93518|NCT02343042|"~     This study will independently assess the efficacy and safety of six combination therapies for~     the treatment of patients with Relapsed/Refractory Multiple Myeloma (RR MM) and Newly~     Diagnosed Multiple Myeloma (NDMM). The combinations to be evaluated include: selinexor +~     pomalidomide + dexamethasone (SPd), selinexor + bortezomib + dexamethasone (SVd), selinexor +~     lenalidomide + dexamethasone (SRd), selinexor + pomalidomide + dexamethasone + bortezomib~     (SPVd), selinexor + daratumumab + dexamethasone (SDd), and selinexor + carfilzomib +~     dexamethasone (SKd).~      The abbreviations for combination treatments have been revised to use V (Velcade) for~     bortezomib, R (Revlimid) for lenalidomide, D (Darzalex) for daratumumab, and K (Kyprolis) for~     carfilzomib.~   "
93519|NCT02343029|"~     Physical activity exerts a variety of long-term health benefits in older adults.This~     randomised controlled trial investigates the effect of a 12-week physical exercise program on~     the change in cerebral metabolism as assessed with Magnetic Resonance Spectroscopic Imaging.~     Follow-up lasts for 6 months.~   "
93520|NCT02343016|"~     The aim of the investigators work is to describe the agreement between NIRS and ecodoppler,~     as monitoring systems of liver and kidney graft's perfusion in the immediate postoperative~     period in pediatric patients.~   "
93521|NCT02343003|"~     This study is designed to:~        -  Determine the effectiveness (primarily measured by pain relief) of Coolief when used to~          create radiofrequency lesions of the genicular nerves compared to pain relief following~          corticosteroid injection; and~        -  Confirm the safety of Coolief when used to perform radiofrequency lesions of the~          genicular nerves in subjects to manage knee pain compared to safety of corticosteroid~          injection~   "
93522|NCT02342990|"~     Periventricular Leukomalacia (PVL) is a white matter lesion surrounding the lateral~     ventricles of the brain occurring in the prenatal period, associated with a disorder of~     movement and posture, known as bilateral cerebral palsy. Children with PVL and bilateral~     cerebral palsy have spared verbal abilities, as measured by verbal Intelligence Quotient~     (verbal IQ) tests, while non-verbal intelligence and especially visuo-perceptual and~     visuo-spatial abilities are impaired. In addition some studies underline the impact of PVL~     also on executive function, especially in terms of working memory and in the ability to~     inhibit distraction.~      Working Memory is the ability to retain and manipulate information for brief periods of time.~     It is important in several complex cognitive functions, such as academic learning and in~     planning and organizing daily life activities. School-based activities, indeed, such as math~     and reading depend on a student's ability to pay attention to several instructions or~     information and to hold and integrate them in their mind.~      Recent behavioural and neurofunctional studies describes the effect of an evidence-based and~     computer-based training on working memory, the Cogmed Working MemoryTraining. Functional MRI~     show increase in parietal and prefrontal activity after this training, while the behavioural~     data demonstrate the generalization of this effect also on cognitive functions not directly~     trained, as attention, inhibition, learning and non-verbal reasoning. Cogmed Working~     MemoryTraining (RoboMemo®, CogMed-Cognitive Medical Systems, Stockholm, Sweden) is an online~     treatment comprising a number of visuo-spatial and verbal exercises that vary automatically~     depending on the individual child's performance in any given task. The training period is~     intensive and includes 25 home session for five weeks, 30-45 minutes each day. A~     Cogmed-trained coach monitors training progress and participants' commitment daily.~      Only one ongoing study has used the CogMed training in children with cerebral palsy, but~     without investigating the correlation between behavioural findings with neurofunctional data.~      The aim of this study is to analyze the effect of the working memory training with CogMed on~     trained and not directly trained cognitive abilities and on the changes in cortical~     electrophysiological reorganization during the sleep after training. The sleep analysis will~     be focused in particular on the slow waves activity [frequency range of 1-4.5 Hz] and on the~     sleep spindle [frequency range of 12-14Hz], which reflect the depth of sleep and are related~     to memory processes, learning and brain plasticity.~      The results of this project will shed light on the mechanisms of neuroplasticity, by~     enhancing knowledge on the neuropsychological effects of a specific working memory training~     and on the neurophysiological underpinnings of these behavioural effects in a clinical~     population of children with congenital brain lesions, as PVL.~   "
93523|NCT02342977|"~     The purpose of this study is to determine how effect lacosamide is in reducing the amount of~     pain medication needed following a total hip arthroplasty. The study team hypothesizes that a~     single dose of lacosamide will reduce the amount of pain medication required after surgery.~     The study team plans to evaluate the amount of pain medication needed and quality of pain~     control during a subject's hospital stay and at their three month follow-up visit following~     their surgery.~   "
93524|NCT02342964|"~     Non-invasive methods of the quantification of fibrosis may help to assess the development of~     fibrosis at a specific moment of the evolution of the disease, in the order to decide the~     initiation of treatment with ursodeoxycholic acid which may slow the progression to hepatic~     cirrhosis:~        -  FibroTest,~        -  The ultrasound impulse elastography, Fibroscan (FS)~        -  Ultrasound Elastography by ShearWave (SWE)~        -  Magnetic resonance elastography (MRE). The purpose of this study is to assess the~          contribution of these methods in the diagnosis of hepatic fibrosis during the evolution~          of the cystic fibrosis.~   "
93525|NCT02342951|"~     The purpose of this study is to determine the efficacy of a non invasive method of detecting~     the pulmonary disease in order to initiate treatment against cystic fibrosis as soon as~     possible.~      Moreover this screening procedure permits to note the improvement following the treatment and~     to choose the optimal treatment in term of efficacy.~   "
93526|NCT02342938|"~     The SEMAINE project will investigate intracranial EEG (icEEG) simultaneously recorded with~     either fMRI or MEG to 1) improve identification of the epileptogenic zone in patients~     suffering from drug-resistant partial epilepsy, and 2) define the functional organization of~     neural networks underlying human perception and cognition in order to prevent inadvertent~     deficits resulting from neurosurgical resection. In particular, high-frequency activity~     (HFA), as measured with icEEG, has been demonstrated in recent years as a relevant index for~     both epileptogenic tissue and healthy cortical processing, but its correlates in fMRI and MEG~     require further investigation. This will be a pioneering effort in several respects, as the~     first to directly measure high-frequency neural activity in tandem with fMRI, and among the~     first to do so with MEG. In addition to their attractiveness as noninvasive imaging~     techniques, fMRI and MEG have the potential to examine whole-brain networks that are not~     accessible to icEEG's necessarily limited spatial coverage. Furthermore, such a campaign of~     simultaneous recordings will take unprecedented advantage of icEEG as the bridge between the~     two noninvasive techniques, providing compelling evidence for the links between all three~     measurements with respect to underlying high-frequency neural activity in both health and~     disease. This project will therefore lead to improved selection of epilepsy surgery~     candidates and improved neurosurgical outcomes from the precise mapping of epileptogenic and~     healthy brain networks. The same techniques will be immediately applicable to functional~     mapping of other types of neurosurgery populations as well as diagnostic neuroimaging of~     neurological and psychiatric populations.~   "
93527|NCT02342925|"~     This single-center, non-randomized, open-label, two treatment, two period, fixed sequence~     crossover study will investigate the effect of RG1662 treatment on the activity of key renal~     transporters in healthy male and female participants using metformin. The effect of RG1662 on~     other renal function parameters will also be explored.~   "
93528|NCT02342912|"~     This is a randomized trial designed to translate and deliver programs via social media for a~     healthy body weight to university students. Specifically, in this trial, we will randomly~     assign 450 overweight/obese (BMI between 25-45kg/m2) university students (ages 18-35)~     enrolled at two colleges (George Washington University and University of~     Massachusetts-Boston) to one of two social media weight loss treatments (personalized or~     generic) or a contact control. The social media treatments consist of Facebook groups to~     provide social support, connectedness and intervention content, as well as daily text~     messages. Assessments will be conducted at baseline, 6, 12, and 18 months post baseline, with~     the primary outcome being weight loss at 18 months. We hypothesize that: a) Tailored Social~     Media will lose significantly more weight at the above time points compared with Targeted~     Social Media. b) Both the Tailored Social Media and Targeted Social Media groups will have~     greater weight loss at the 6, 12, 18 month follow-ups than Contact Control. The secondary aim~     is to evaluate changes in metabolic risk factors among those participants who have maintained~     at least 5% weight loss at 18 months. We hypothesize that participants who achieve a 5%~     weight loss at 6 and 18 months will have significantly lower triglycerides, higher HDL~     cholesterol, and lower blood pressure than those who do not achieve and maintain that weight~     target. Finally, we will conduct additional formative work to evaluate the implementation~     feasibility of this intervention on college campuses, including an assessment of costs as~     well as the sustainability infrastructure using the PRISM (Practical, Robust Implementation~     and Sustainability Model) model as a guide. The results of this study have the potential to~     significantly impact the delivery of obesity treatment services on college campuses.~   "
93529|NCT02342899|"~     Obesity is an escalating issue, with an accompanying increase in referrals of patients with~     obesity-related respiratory failure. Currently, these patients are electively admitted to~     hospital for initiation of non-invasive ventilation (NIV), but it is unknown whether~     outpatient initiation is as effective as inpatient set-up. The investigators hypothesise that~     outpatient set up using an auto-titrating NIV device will be more cost effective than~     nurse-led inpatient titration and set-up.~      The investigators will undertake a multi-national, multi-centre randomised controlled trial.~      Subjects will be randomised to receiving usual inpatient set-up, which will include nurse-led~     initiation of NIV or outpatient set-up with an automated NIV device. Subjects will be~     stratified according to trial site, gender and previous use of NIV or continuous positive~     airway pressure. Assuming 10% drop out rate, a total sample of 82 patients will be required.~     Cost effectiveness will be evaluated using standard treatment costs and health service~     utilisation and using health related quality of life measures (SRI and EQ5D). Change in the~     severe respiratory insufficiency (SRI) questionnaire will be based on analysis of covariance~     (ANCOVA) adjusting for the baseline measurements between the two arms of patients.~   "
93530|NCT02342886|"~     The purpose of this study is to assess the efficacy, safety and tolerability of a combination~     of moxifloxacin, PA-824, and pyrazinamide treatments with varying doses and treatment lengths~     from 4 to 6 months in subjects with drug-sensitive (DS) pulmonary TB compared to standard~     HRZE treatment.~      This study will also assess the efficacy, safety and tolerability of a combination of~     moxifloxacin, PA-824, and pyrazinamide treatments after 6 months of treatment in subjects~     with multi drug-resistant (MDR) pulmonary TB compared to a combination of moxifloxacin,~     PA-824, and pyrazinamide treatments in DS-TB subjects.~   "
93531|NCT02342873|"~     The investigators compared the postoperative analgesia of nerve stimulator-guided and~     ultrasound-guided interscalene block after shoulder surgery.~   "
93532|NCT02342860|"~     The investigators will conduct a cluster-randomized trial to assess the impact of a~     school-based water, sanitation and hygiene program on health and educational outcomes of~     school children in Saravane Province, Laos. The intervention will include an improved water~     supply (borehole), a sanitation block that includes three pour-flush latrines with rainwater~     harvesting to be used for flushing and a urinal, and sinks for handwashing with soap. The~     school will also receive a facility for group handwashing (large pipe where many children can~     wash hands at once. United Nations International Children's Emergency Fund (UNICEF) will~     additionally provide behavior change education. Our key outcome of interest is pupil absence,~     which will be measured longitudinally using roll-call on days of schools visits. Secondary~     outcomes include self-reported absence, diarrhea and respiratory infection of a random~     selection of students. The investigators will also monitor the fidelity of the intervention~     and assess school conditions and pupil sanitation and handwashing behaviors using structured~     observation.~   "
93533|NCT02342847|"~     This is an observational, post-authorization, prospective follow-up, multi-centre, national~     study designed to describe the spectrum of health-related quality of life in patients with~     metastatic pancreatic cancer previously untreated with chemotherapy This study is designed to~     observe patients treated in routine clinical practice, without the exclusion limitations of a~     clinical trial. Patients will be enrolled in 7 Spanish sites. In all cases, the decision to~     treat patients will be performed prior to the decision to include the patient in the study.~      Given the observational nature of the study, follow-up of patients will be performed~     according to standard clinical practice of each site.~   "
93534|NCT02342834|"~     The purpose of this study is:~        -  to measure the size of the effect on glucose tolerance of a small mixed protein and~          lipid meal given as a pre-load in individuals with different glucose tolerance status~        -  to investigate the underlying mechanisms by accurately evaluating beta cell function,~          insulin sensitivity, insulin clearance and glucose kinetics (oral absorption, endogenous~          production, rate of utilization) together with gut hormones plasma concentration.~   "
93535|NCT02342821|"~     This Study will attempt to provide information / linkage to HBV care for persons at risk in~     the Greater Boston area.~   "
93536|NCT02342808|"~     This study will examine the effects of lifestyle intervention on fitness, dietary habits, and~     body weight in patients with resistant hypertension (RH). Patients will be randomized to~     either a 4-month adjunctive lifestyle intervention designed to lower BP that will be~     delivered in a center-based CR program (C-LIFE), or to standardized education and physician~     advice (SEPA) designed to promote the same healthy behaviors and reflecting the current~     highest possible standard of care for promoting a healthy lifestyle in RH.~   "
93537|NCT02342795|"~     The purpose of this study is to use Randomized Controlled Trial (RCT) methods to examine the~     influence of novel tobacco products on biomarkers of toxicant exposure and disease risk,~     reports of adverse events, and concurrent use of other tobacco products. In this case, the~     novel products are one type of electronic cigarette and an imitation cigarette or cigarette~     substitute.~   "
93547|NCT02342665|"~     The primary objective of this study is to assess the safety profile of copanlisib at the~     recommended dose (primary endpoint). The recommended dose of copanlisib for Japanese patients~     will be determined in the dose escalation/safety evaluation part~   "
93538|NCT02342782|"~     This phase I trial studies the side effects and best dose of yttrium Y 90 basiliximab when~     given together with standard combination chemotherapy before a stem cell transplant in~     treating patients with mature T-cell non-Hodgkin lymphoma. Radioactive substances linked to~     monoclonal antibodies, such as yttrium Y 90 basiliximab, can bind to cancer cells and give~     off radiation which may help kill cancer cells. Drugs used in chemotherapy, such as~     carmustine, cytarabine, etoposide, and melphalan (BEAM), work in different ways to stop the~     growth of cancer cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Giving yttrium Y 90 basiliximab and chemotherapy before a stem~     cell transplant may help kill any cancer cells that are in the body and help make room in the~     patient's bone marrow for new blood-forming cells (stem cells) to grow. Stem cells that were~     collected from the patient's blood and stored before treatment are later returned to the~     patient to replace the blood-forming cells that were destroyed.~   "
93539|NCT02342769|"~     TRIUMPH is a prospective, non-interventional observational study on the use of the fixdose~     combination TRIUMEQ (Dolutegravir/Abacavir/Lamivudine) and the respective monitoring measures~     in the practice of HIV care in Germany. The primary study objective is a descriptive report~     of the incidence of therapeutic monitoring measures in HIV-infected patients under TRIUMEQ~     therapy in everyday routine practice in Germany. The study is designed to enroll~     approximately 400 patients. There are no protocol-mandated visits or procedures associated~     with the study. Each patient is expected to participate for a maximum of 3 years or until~     premature discontinuation (i.e., discontinuation of TRIUMEQ, due to death, withdrawal of~     consent, lost to follow-up. TRIUMEQ is a registered trademark of the ViiV Healthcare group of~     companies.~   "
93540|NCT02342756|"~     The use of positive end-expiratory pressure (PEEP) has been shown to prevent the cycling~     end-expiratory collapse during mechanical ventilation and to maintain alveolar recruitment,~     keeping lung portions open, increasing the resting end-expiratory volume. On the other hand~     PEEP may also overdistend the already open lung, increasing stress and strain.~      Theoretically high frequency oscillatory ventilation (HFOV) could be considered an ideal~     strategy in patients with ARDS for the small tidal volumes, but the expected benefits have~     not been shown yet.~      PEEP and HFOV should be tailored on individual physiology. Assuming that the esophageal~     pressure is a good estimation of pleural pressure, transpulmonary pressure can be estimated~     by the difference between airway pressure and esophageal pressure (PL= Paw - Pes). A PL of 0~     cmH2O at end-expiration should keep the airways open (even if distal zones are not certainly~     recruited) and a PL of 15 cmH2O should produce an overall increase of lung recruitment.~      The investigators want to determine whether the prevention of atelectrauma by setting PEEP~     and mPaw to obtain 0 cmH2O of transpulmonary pressure at end expiratory volume is less~     injurious than lung recruitment limiting tidal overdistension by setting PEEP and mPaw at a~     threshold of 15 cmH2O of transpulmonary pressure.~      The comparison between conventional ventilation with tidal volume of 6 ml/Kg and HFOV enables~     us to understand the role of different tidal volumes on preventing atelectrauma and inducing~     lung recruitment.~      The use of non-invasive bedside techniques such as lung ultrasound, electrical impedance~     tomography, and transthoracic echocardiography are becoming necessary in ICU and may allow us~     to distinguish between lung recruitment and tidal overdistension at different PEEP/mPaw~     settings, in order to limit pulmonary and hemodynamic complications during CMV and HFOV.~   "
93541|NCT02342743|"~     The purpose of this pilot study is to assess the efficacy of the Cefaly device in the~     treatment of chronic migraine prior to implement a control trial where the size and final~     protocol will be specified thanks to the outcomes of this pilot trial.~   "
93542|NCT02342730|"~     This pilot clinical trial studies whether obese stage I-II endometrial cancer survivors or~     patients with atypical hyperplasia (abnormal cells in the lining of the uterus) would go see~     a weight loss specialist if it was recommended by their cancer doctor. Excess body weight or~     obesity is one of the most common contributors to (causes of) endometrial cancer. Over~     two-thirds of women who have survived endometrial cancer are obese. Complications of obesity,~     such as heart disease are often more dangerous than the cancer itself. A weight loss of even~     5-10% of excess body weight is associated with improved health. Often, meeting with a doctor~     or person who is an expert in weight loss (bariatric specialist) is the best way to lose~     weight and keep it off. Endometrial cancer survivors or patients with atypical hyperplasia~     who go see a weight loss specialist recommended by their doctor may be able to achieve a~     healthier body weight.~   "
93543|NCT02342717|"~     To investigate whether and to what extent co-administration of multiple doses of itraconazole~     affect single dose pharmacokinetics of BI 425809 in healthy male subjects~   "
93544|NCT02342704|"~     The primary objective of this study is to assess the effect of natalizumab compared to~     fingolimod on the evolution of new on-treatment T1-gadolinium-enhancing (Gd+) lesions to~     persistent black holes (PBH) over 52 weeks. The secondary objectives of this study in this~     study population are to assess the effect of natalizumab compared to fingolimod on: magnetic~     resonance imaging (MRI) measures of central nervous system (CNS) tissue destruction as~     measured by the number of new T1-Gd+ lesions; various other MRI measures of disease activity;~     No Evidence of Disease Activity (NEDA); Relapse on treatment over 52 weeks; The change in~     information processing speed as measured by the Symbol Digit Modalities Test (SDMT).~   "
93545|NCT02342691|"~     The primary objective is to evaluate the safety of an investigational compound, BLXA4-ME,~     topically applied as a daily oral rinse in adults with gingivitis. Safety will be assessed by~     the incidence of adverse events, including mucosal inflammation and irritancy and findings~     from safety labs. Subjects will be monitored for development of periodontitis, and oral flora~     will be analyzed to detect an increase in opportunistic organisms.~      The secondary objective is to assess preliminary efficacy of the oral rinse, by monitoring~     changes in the plaque index (PI), modified gingival index (MGI), bleeding on probing (BOP)~     and levels of interleukin -1β (IL-1β) in gingival crevicular fluid (GCF).~      The study comprises three groups in a randomized, placebo-controlled double-blind clinical~     trial design. The treatment group (1.0 μM BLXA4-ME oral rinse) and the placebo rinse group~     will each include 50 subjects. The no-rinse control group will consist of 25 subjects.~     Subjects in the treatment and placebo rinse groups will receive oral rinse (BLXA4-ME or~     placebo) to be applied once daily after morning teeth brushing. Safety parameters will be~     assessed before and after 3, 7, 14, 21, and 28 days of treatment. Efficacy parameters will be~     assessed before and after 14 and 28 days of treatment.~   "
93546|NCT02342678|"~     The LILA study is a pilot randomized parallel-group trial of a group-based yoga therapy~     program versus physical conditionin control program for treatment of urinary incontinence in~     ambulatory middle-aged and older women. Women aged 50 years and older who meet the criteria~     for frequency of incontinence episodes, are not using other clinical treatments for~     incontinence, and meet minimum physical mobility requirements and other eligibility criteria~     will be recruited from the general San Francisco Bay Area.~   "
93551|NCT02342613|"~     This Phase 1 clinical study is designed to examine the safety and feasibility of using~     anti-CD3/CD28 activated marrow infiltrating lymphocytes (MILs) as treatment of relapse after~     allogeneic hematopoietic cell transplantation (alloHCT) for patients with hematologic~     malignancies with bone marrow involvement of their relapsed disease. These MILs will be~     derived from the bone marrow of the relapsed patient who had previously received~     post-transplantation cyclophosphamide (PTCy) as graft-versus-host disease (GVHD) prophylaxis~     (PTCy-MILs). A bone marrow aspiration will be performed on the patient to collect ~200ml of~     marrow for ex vivo expansion. During this expansion process, T cells will be activated and~     expanded by co-stimulation with anti-CD3/anti-CD28 monoclonal antibodies covalently attached~     to super-paramagnetic microbeads. Patients will be treated with salvage therapy while this ex~     vivo expansion is ongoing. After the simultaneous salvage therapy and ex vivo expansion, the~     activated PTCy-MILs will be reinfused. Patients will be monitored with the primary objective~     being the feasibility of expanding to targeted dose levels activated PTCy-MILs that do not~     cause grade III-IV acute GVHD within the first 90 days after PTCy-MIL infusion.~   "
93552|NCT02342600|"~     This study evaluates the combination of trametinib and pazopanib in patients with advanced~     gastrointestinal stromal tumors (GIST).~   "
93553|NCT02342587|"~     Although anti-HER2 (human epidermal growth factor receptor 2) therapy is currently approved~     for breast, gastric, and gastroesophageal cancers overexpressing the HER2 protein or~     amplified for the HER2 gene, HER2 aberrations (gene amplification, gene mutations, and~     protein overexpression) are reported in other diverse malignancies. Indeed, about 1-37% of~     tumors of the following types harbor HER2 aberrations: bladder, cervix, colon, endometrium,~     germ cell, glioblastoma, head and neck, liver, lung, ovarian, pancreas, and salivary duct.~      Lapatinib is an orally active, reversible, small molecule TKI that potently inhibits both~     ErbB1 and ErbB2 tyrosine kinase activity. Data suggest that a dual ErbB1 and ErbB2 inhibitor~     may provide improved therapeutic benefit compared with inhibitors that target only one or the~     other receptor.~      Therefore, this phase 2 study is designed to evaluated the activity of lapatinib in patients~     with HER2-positive refractory cancer.~   "
93554|NCT02342574|"~     Double blind, placebo controlled, parallel group ascending dose study evaluating single and~     multiple (x8 days) dose levels of F901318 in groups of male healthy subjects with the~     objective of defining a dosing schedule for phase ll clinical trials. F901318, a novel and~     potent antifungal agent for the treatment of invasive aspergillosis, will be delivered~     intravenously in a range of dosing schedules driven by pharmacokinetic evaluation in real~     time. Safety and tolerability of those schedules will also be assessed.~   "
93555|NCT02342561|"~     This study evaluates the effect of Iodine-impregnated self-adhesive plastic drapes (IIAD) on~     the quantity of skin bacteria, which is a known factor in the development of surgical site~     infections in orthopedic surgery. 16 patients scheduled for total knee replacement surgery~     (TKA) are recruited for participation in an intervention performed at the orthopedic ward of~     Odense University Hospital, Denmark.~      Right or left patient knee is randomized to receive draping with IIAD, while the other knee~     is not draped. Local standard preoperative procedure for knee surgery is then simulated.~      After 75 minutes both knee are sampled for bacterial quantity using the cup scrub method and~     samples are aerobically incubated. The bacterial growth of the IIAD and no-drape group are~     then compared using nonparametric statistics.~   "
93556|NCT02342548|"~     This study is a 12 month open label extension study of PF-02545920 20 mg dosed BID following~     study A8241021 in subjects with HD. Primary endpoints will be to assess long-term safety and~     tolerability of 20 mg BID of PF-02545920. Secondary endpoints will be the change from~     baseline in the Total Motor Score (TMS)assessment, and/ior the Total maximum Chorea (TMC)~     assessment of the Unified Huntington Disease Rating Scale (UHDRS) after 6 and 12 months of~     treatment, and Clinical Global Impression-Improvement score after 6 and 12 months of~     treatment. Subjects, who were assigned to the 20 mg PF-02545920 dose group in the preceding~     A8241021 study, will receive 20 mg PF-02545920 without any titration. All other subjects will~     be titrated to the 20 mg BID dose as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15~     mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Up to 260~     subjects may take part in this open label extension~   "
93557|NCT02342535|"~     The goal of this study is to pilot-test a culturally-salient physical activity intervention,~     using a randomized design, among under served, overweight/obese South Asian women at high~     risk for developing Diabetes.~   "
93558|NCT02342522|"~     The purpose of this study is to determine whether remote ischemic conditioning can reduce~     cardiac death and hospitalization for heart failure in patients presenting with a~     ST-elevation myocardial infarction and treated by percutaneous coronary intervention.~   "
93559|NCT02342509|"~     The new MIRUS system as well as the established AnaConDa system uses a reflector to conserve~     volatile anaesthetics (VA). Both systems act with commercially available ICU ventilators. In~     contrast to AnaConDa the MIRUS includes an automated control of end-tidal VA concentrations.~     In this study the investigators compared feasibility, costs and recovery times after~     anaesthesia with isoflurane (ISO), sevoflurane (SEVO) or desflurane (DES) in ventilated and~     spontaneously breathing patients.~   "
93560|NCT02342496|"~     The purpose of this study is to evaluate the ability of a blend of berries and probiotics in~     reducing low-grade inflammation and intestinal permeability in the elderly. The intervention~     period is one month. Blood and fecal samples will be collected for analysis at baseline and~     at the end of the intervention with the aim to analyse possible changes in different~     parameters at the two timepoints. The participants will also be asked to keep a study diary~     throughout the study period for the documentation of their intestinal health and as a means~     for checking compliance.~   "
93561|NCT02342483|"~     This randomized, double-blind, adaptive design study aims to prove that the~     Methylsulfonylmethane study product improves nasal breathing and stuffy nose symptoms after~     exposure to environmental allergens. Endpoints include percent change in Peak Nasal~     Inspiratory Flow, VAS Nasal Symptom Score, number of sneezes and number of used tissues in~     response to allergen exposure.~   "
93562|NCT02342470|"~     The purpose of this study is to evaluate the efficacy and safety by comparing prevention of~     recurrent peptic ulcer in low-dose aspirin users between PMK-S005 and Placebo.~   "
93563|NCT02342457|"~     Children with chronic constipation, suspected of having hirschsprungs disease, who are~     admitted for rectal biopsy will be included in the study. During the procedure,~     electrophysiological reading from the site chosen for biopsy will be done. Correlation~     between electrophysiological data and histopathology will be analyzed.~   "
93564|NCT02342444|"~     The risk of developing a blood clot occurs in up to 60% of all critical care patients. Many~     times enoxaparin (or Lovenox) is given to patients who are at a higher risk of developing~     clots in their legs or lungs. There are two standard doses of enoxaparin that are recommended~     by the drug companies. These two doses have never been directly compared in trauma, general,~     and vascular surgery patients. The purposes of this study are:~        1. to compare the development of blood clots in patients receiving 30mg twice daily of~          enoxaparin compared to patients receiving 40mg once daily of enoxaparin.~        2. to determine if there is higher risk of bleeding complications in patients receiving~          30mg twice daily of enoxaparin compared to patients receiving 40mg once daily.~      Patients enrolled into the study will be randomized to receive enoxaparin, 30mg twice daily~     or enoxaparin, 40mg once daily. Patients will then be monitored for signs and symptoms of~     blood clots. At the time of discharge (or before, if medically indicated), an ultrasound test~     will be performed to look for blood clots in the patient's legs.~      The investigators will compare incidence of blood clots formed between the 2 groups of~     patients to determine if one dose of enoxaparin relates to a lower rate of blood clots in~     critically ill patients. The investigators will also compare the incidence of bleeding~     complications between the 2 groups.~   "
93565|NCT02342431|"~     The study is a comparison of a patient warming system using a forced-air, non-compressible~     under-body mattress (Möck & Möck, Hamburg, Germany) versus a regular forced-air underbody~     mattress system during pediatric cardiac catheterization in 40 patients.~      The hypothesis is, that the non-compressible mattress provides better warming with less~     incidence of perioperative hypothermia (Core temperature < 36 °C) and faster warming slope~     (°C / time). The study is prospective, randomized, controlled and single-blinded.~      Inclusion criteria will be pediatric patients < 1 year of age without fever or a treatment of~     therapeutic hypothermia.~   "
93566|NCT02342418|"~     This is an open label, single-dose, pharmacokinetic study in 9 obese and 9 age-, sex-, ideal~     body weight- matched non-obese subjects. Qualifying subjects who have completed an informed~     consent will receive a single intravenous dose of tedizolid with the collection of 11 blood~     samples over 72 hours post dose.~   "
93567|NCT02342405|"~     The frequency of preoperative cardiac ischemia and the 30-days postoperative mortality is~     much higher than previously assumed, with approximately 10 % of patients undergoing~     non-cardiac surgery suffering from postoperative myocardial injury. A recent danish study~     furthermore showed that patients treated with a high inspiratory oxygen fraction during~     surgery had a higher 1 year mortality compared with patients treated with a low inspiratory~     fraction. This was especially significant among patients undergoing cancer surgery. A~     possible explanation, is that a high oxygen fraction results in oxidative stress and~     endothelial dysfunction.~      With this randomized cross-over study we wish to investigate the effect of a high inspiratory~     oxygen fraction on the endothelial function among healthy male volunteers. The primary~     outcome is the endothelial function assessed by the EndoPat system. Secondary outcomes are~     changes in oxidative biomarkers. Heart rate variability (HRV) recordings will serve as a~     measure for the effect of oxygen on the autonomic nervous system.~   "
93568|NCT02342392|"~     The purpose of this study is to evaluate the pterygium vascularity and size before and after~     intralesional ranibizumab injection and to evaluate its recurrence rate following pterygium~     excision surgery.~   "
93569|NCT02342379|"~     Dual center, single arm, two-stage, non-blinded, prospective study of combination therapy~     bevacizumab at 10mg/kg and TH-302 at 670mg/m2 every 2 weeks (6 week cycle) until disease~     progression.~   "
93570|NCT02342366|"~     The purpose of this study is to determine whether gamma-Hydroxybutyrate (GHB) has prosocial~     and prosexual effects in healthy male participants, and to characterize these putative~     effects via behavioral tests, functional magnetic resonance imaging (fMRI),~     electroencephalography (EEG), and neuroendocrine parameters. The investigators predict that~     GHB in fact has prosocial and prosexual effects which can be neurobiologically characterized~     using the assessed methods. Such effects would be of high interest for the treatment of~     mental disorders which involve impairments of social interaction and sexual function such as~     major depression or autism.~   "
93571|NCT02342353|"~     The goal of the study is to find the best dose of pacritinib when given in combination with~     erlotinib.~   "
93572|NCT02342340|"~     This is a single site, blinded, randomized, controlled study designed to examine~     phytochemical absorption, metabolism and excretion, as well as vascular health and satiety,~     after ingestion of 4 different bean varieties (pinto, navy, red kidney, black). Eligible~     participants will attend 6 in-person clinic visits for comparative testing of the 4 bean~     varieties versus lentils and rice.~   "
93573|NCT02342327|"~     The purpose of this study is to determine if in smokers of menthol cigarettes, switching to~     non-menthol cigarettes prior to a cessation attempt results in greater cessation success than~     attempting to quit without first switching~   "
93574|NCT02342314|"~     The study involves a single dose of LY3143753 or LY3185643, given as an injection into the~     abdomen. The study will evaluate the effects of the LY3143753 or LY3185643 on your body. The~     study is approximately 12 weeks for each participant, not including screening. Screening is~     required within 28 days prior to the start of the study. This study involves Part A~     (LY3143753) and Part B (LY3185643). Participants may only enroll in one part and at one dose~     level.~   "
93575|NCT02342301|"~     We aim to determine if changing a person's workstation from a traditional seated desk to a~     height adjustable standing desk for a period of approximately 3 months is associated with~     alterations in traditional measures of cardiometabolic risk.~   "
93624|NCT02341664|"~     The purpose of the Patient and Provider Assessment of Lipid Management Registry (PALM) is to~     gain a better understanding of physicians' cholesterol medication prescribing practices,~     patient and physician attitudes and beliefs related to cholesterol management, and current~     utilization of cholesterol-lowering therapies given the new ACC/AHA guideline~     recommendations. The PALM Registry hopes to allow for the design of ways to improve~     cholesterol management and decrease the burden of cardiovascular disease (CVD) in the US.~   "
93576|NCT02342288|"~     A rare but terrible complication of vision loss has been known to occur after surgery,~     including spine surgery. It is commonly thought that increased intraocular pressure (IOP) is~     one of the reasons for this rare vision loss. It has been shown that the prone position can~     increase the IOP, and that tilting the patient with the head down can also increase IOP. The~     investigators will be measuring IOP before, during, and after a posterior spine surgery to~     see if the investigators can influence the intraocular pressure with elevated head position~     change. Two groups will be studied: one group of patients will receive standard care with the~     head in neutral position, while the other group will have the head slightly elevated 10~     degrees during prone spine surgery.~   "
93577|NCT02342275|"~     The purpose of this study is to compare the efficacy of orally administered propranolol~     versus atenolol in the treatment of potentially disfiguring or functionally threatening IHs.~   "
93578|NCT02342262|"~     RATIONALE: The prevalence of migraine is higher in patients with various intestinal diseases.~     An explanation could be that migraine is caused by a 'leaky gut': an increased intestinal~     permeability that allows food particles to pass the gastrointestinal wall. Probiotics may be~     able to improve intestinal barrier function.~      OBJECTIVE: To test whether probiotics, as adjuvant therapy, can reduce incidence and severity~     of migraine attacks by reducing intestinal permeability.~      STUDY DESIGN: 12-week placebo-controlled randomized double-blind intervention with selected~     probiotics.~      STUDY POPULATION: Adults who experience at least 4 migraine attacks per month. INTERVENTION:~     Subjects will receive either one daily dose of 2 g of Ecologic® Barrier or 2 grams of the~     placebo, containing only the carrier material (both provided by Winclove Probiotics).~      MAIN STUDY PARAMETERS/ENDPOINTS: Incidence and severity of migraine attacks, measured by~     diaries and validated headache questionnaires will be measured at baseline and after 4, 8,~     and 12 weeks of probiotic/placebo administration. Secondary, intestinal permeability will be~     measured by the lactulose/mannitol absorption test in urine (screening, baseline and 12~     weeks) and by fecal zonulin (baseline, 4, 8, and 12 weeks). Inflammation will be assessed~     from blood C-reactive protein and cytokine concentrations (baseline, 4, 8, and 12 weeks).~     Fecal samples will also be used for microbial analysis.~   "
93579|NCT02342249|"~     The purpose of this study is to evaluate the antiviral effect, as measured by viral titer in~     nasal secretions in adults with acute uncomplicated seasonal influenza A following~     administration of VX-787.~   "
93580|NCT02342236|"~     Postoperative Cognitive Disorders (POCD) are common in hospitalized people > 60 year old,~     especially in orthopedic patients. Etiology of POCD is complex, and in some aspects still~     remains unclear. The role of thromboembolic events in etiology of POCD was discussed. The~     incidence of such events in patients who underwent big joints arthroplasty can be as high as~     40 to 60%, although some cases are subclinical. Thromboembolic material can block a blood~     flow through a vessels in the brain. As a consequence cerebral neurons can be damaged or~     destroyed. After neuronal damage specific substances, such as S100B protein, glial fibrillary~     acidic protein (GFAP) and neuron-specific enolase (NSE) are released to the blood. The serum~     concentrations of these biomarkers can be measured. Moreover, the block of blood flow will~     decrease regional cerebral saturation in affected parts of the brain.~      In this project the authors would like to analyze the correlation between the regional~     cerebral saturation and serum concentration of both S100B protein and GFAP in orthopedic~     patients scheduled to primary hip arthroplasty.~   "
93581|NCT02342223|"~     The purpose of this study is to test the safety of Voluma and see what effects it has on HIV~     facial lipoatrophy. The hypothesis is that Voluma will be safe, efficacious and positively~     impact the quality-of-life in the treatment of facial lipoatrophy in patients with HIV.~   "
93582|NCT02342210|"~     Recent research has suggested that mindfulness-based interventions for psychosis may be~     effective in reducing the negative symptoms of schizophrenia (e.g., social withdrawal, lack~     of motivation) and the distress associated with psychotic symptoms (e.g., hearing voices) and~     could lead to improvements in functioning and quality of life. However these findings are~     based on small studies that largely consist of patients with chronic illness. Little is yet~     known about the use of mindfulness interventions for young people recovering from their first~     episode of psychosis.~      The purpose of this study is to determine whether the Mindfulness Ambassador Council (MAC), a~     12-week facilitated group intervention promoting mindfulness skills and the development of~     emotional and social competencies, is an effective, feasible, and acceptable means of~     treating youth in the early stages of psychotic illnesses. Although the current study is~     hypothesis generating in nature, based on previous investigations of Mindfulness Based~     Interventions for psychoses (Chadwick, 2014), we are expecting that participating in the MAC~     intervention will result in improvements in clinical, cognitive, functional, and health~     service utilization parameters. Additionally, we expect that the MAC intervention will prove~     to be acceptable to participants and a feasible intervention for early psychotic disorders.~   "
93583|NCT02342197|"~     Objective: To compare two stimulation protocols, the minidose long protocol and the microdose~     flare protocol designed for low responders undergoing ICSI.~      Design: Randomized prospective study. Setting: University hospital IVF unit. Patients: 60~     poor responder patients coming for IVF center for ICSI. Interventions: Minidose long protocol~     in which half the dose of agonist was administered from the mid luteal phase until the day of~     HCG administration was compared with microdose flare protocol in which half the dose of GnRH~     was administered from the second day of the cycle until the day of HCG administration. Both~     groups received Gn stimulation from the second day of the cycle (300-450 IU).~      Main outcome measures: Number of oocytes retrieved.~   "
93584|NCT02342184|"~     This study will carry out to assess the efficacy of GB-0998 (intravenous~     immunoglobulin;400mg/kg/day for five days) in the treatment of the Guillain-Barré Syndrome~     based on the changes in Hughes Functional Grade (FG) as primary endpoint, and in addition, to~     assess the safety of GB-0998.~   "
93618|NCT02341742|"~     This study is an observational study. The purpose of this study is to assess the relationship~     between bone health and daily physical activity in children and adolescents with inflammatory~     bowel disease (IBD). Reduced bone mineral density is a common complication in pediatric IBD.~     Physical activity is an important determinant of health throughout the whole lifespan.~     Engaging in regular moderate-to-vigorous physical activity has important health benefits.~     Based on available evidence, the investigators hypothesize that daily moderate-to-vigorous~     physical activity could improve bone health (ie bone mineral density) in children and~     adolescents with IBD.~   "
93585|NCT02342171|"~     This is an emergency, phase 2/3, open-label, non-randomized, clinical trial that will~     evaluate Convalescent Plasma (CP) added to standardized supportive care (SC) in patients with~     confirmed Ebola Virus Disease (EVD). No patient will be refused CP when compatible products~     are available and all efforts will be made to maximize CP availability during the study. EVD~     patients recruited during the period before CP becomes available or for whom no compatible CP~     is available will be given SC and will be followed for study outcomes. Data from these SC~     patients will be the used as comparator in the analysis of the study. The primary objective~     of the study is to assess if CP + SC improves the 14 day survival of patients, compared to SC~     alone.~      The Investigators aim to enroll a total number of 130 - 200 patients who will be treated~     treated with CP assuming equal numbers of patients treated with SC alone. If there would be~     insufficient patients treated with SC, patients treated at the research site prior to study~     start may be included in the comparison group.~      Patients will be recruited in the Ebola Treatment centre managed by Medecins Sans Frontieres~     (MSF) in Conakry, Guinea. All patients and/or relatives presenting at the centre will be~     informed about the study, and will be invited to provide consent at the time of admission~     inside the treatment centre. Only patients for whom ebola infection is confirmed with~     polymerase chain reaction (PCR) will be enrolled in the study. After inclusion, eligibility~     to the intervention will be reassessed on regular intervals. If the eligibility criteria are~     not met by 48 hours after inclusion, only SC will be continued.~      In line with the guidance of the World Health Organization (WHO), two units of CP will be~     given. EVD patients will be transfused with ABO-compatible CP using standard procedures.~     Details on the modalities of transfusion can be found in the WHO guidance document and the~     MSF guidelines on blood transfusion. All patients will be under close observation for~     transfusion-related adverse reactions during and up to 4 hours after transfusion. 24 hours~     after the start of transfusion, a blood sample will be collected for viral load assessment.~     All other aspects of patient management will be according to MSF clinical guidelines. The~     decision to discharge a patient should be taken on clinical grounds, but can be supported by~     the laboratory results. After discharge, the patient will be followed up by the study team~     until day 30.~   "
93586|NCT02342158|"~     PERMED01 is a prospective monocenter clinical trial which aims to evaluate the number~     patients with locally advanced or metastatic cancer for whom identification of molecular~     alterations in tumor samples can lead to the delivery of a targeted therapy. PERMED01 will~     enroll 460 patients in 3 years.~   "
93587|NCT02342145|"~     The purpose of this study is to evaluate the basiliximab for prevention of graft-versus-host~     disease in unrelated allo-genetic hematopoietic stem cell transplantation for thalassemia~     major. The objective was to evaluate the effect and safety of basiliximab for acute~     graft-versus-host disease.~   "
93588|NCT02342132|"~     Children with neuromuscular diseases (NMDs) and weak chest muscles suffer frequent chest~     infections, hospital admissions and reduced life expectancy. Physiotherapy is widely used but~     there is limited research data to support choice of therapy. The investigators will study the~     clinical value of the three most commonly used chest physiotherapy devices in children with~     NMD's by measuring lung function tests before and after each of the three treatments. This is~     a pilot study. The best device will be selected for a long term study of early physiotherapy~     intervention in children with NMDs.~      The treatments that have been developed to break the cycle of decreasing lung volume and poor~     secretion clearance, in children with NMDs, are all based on the same logical but unproved~     theory of treatment:~        1. The loss of lung volume is reversed by applying positive pressure to the lungs via a~          face mask - literally reinflating the lungs with pressure. The three devices the~          investigators will test all provide positive pressure assistance during the inspiratory~          phase.~        2. The temporarily increased lung volume then allows higher expiratory flow rates which~          helps to clear secretions. The expiratory phase is assisted by manual chest compression~          or, in one device, helped by application of negative pressure during exhalation.~      All three devices that the investigators wish to compare follow this two-step approach. The~     hypotheses behind our study are:~        1. Treatments combining positive pressure inhalation with assisted coughing during~          exhalation, will produce measurable improvements in lung volume and expiratory cough~          flow rates when tested in children with NMDs.~        2. One of the three devices tested will be superior to the others. This will provide~          research-based justification for a long term study of the value of early intervention in~          children with NMDs.~   "
93589|NCT02342119|"~     Living donor kidney transplantation (LDKT) is the optimal treatment for end-stage kidney~     disease (ESKD). But, the evaluation process for a kidney transplant is lengthy, time~     consuming, and burdensome to the patient. Also, race disparities exist in rates of transplant~     evaluation completion, transplantation, and LDKT. Our previous and ongoing NIDDK-funded~     research indicates that cultural factors (i.e., perceived discrimination in health care,~     religious objection to LDKT), transplant knowledge, and demographic characteristics (e.g.,~     age, education, income) independently and significantly predict time to complete transplant~     evaluation. In December 2012 the investigators' transplant center implemented a one-day~     streamlined evaluation process, dubbed Kidney Transplant Fast Track (KTFT), but it has not~     been evaluated for efficacy or cost effectiveness. Thus, the investigators propose a~     quasi-experiment to determine the efficacy and cost-effectiveness of the KTFT (n=1030)~     compared to historical controls (n=1140) who were recruited for the investigators' current~     NIDDK study to increase transplant rates. At the same time, the investigators will conduct a~     randomized controlled trial (RCT) targeting vulnerable patients with the educational~     component of the TALK intervention (Talking About Live Kidney Donation) to increase LDKT. For~     both components of the proposal, the investigators will target vulnerable populations because~     they are most at risk for extended evaluation times and lower rates of LDKT. Using CONSORT~     standards, participants will be randomly assigned to TALK (n=515) versus no-TALK (n=515)~     conditions and undergo two interviews at pre-transplant work-up and at completion of~     transplant evaluation in order to: (1) test whether KTFT and TALK will reduce transplant~     evaluation time, and increase rates of transplant and LDKT in members of vulnerable groups;~     (2) determine whether engaging in a streamlined and coordinated-care evaluation experience~     within the transplant center reduces negative perceptions of the healthcare system; and (3)~     test the cost effectiveness of the KTFT with TALK relative to standard practices. The results~     of this two-pronged approach will help pave the way for other transplant centers to implement~     a fast-track system at their sites, improve quality of care by transplanting a larger number~     of vulnerable patients, and may help address stark race/ethnic disparities in rates of LDKT.~   "
93590|NCT02342106|"~     The investigators will study the immune cell subpopulations in follicular fluid of patients~     undergoing In-Vitro Fertilization (IVF) treatment in our clinic. The investigators will~     corelate the presence of immature myeloid cells to the ovarian stimulation response as~     indicated by follicle stimulating hormone (FSH) and number of follicles or estradiol level~     developed on the day of human chorionic gonadotropin (hCG) administration.~   "
93591|NCT02342093|"~     Background: Drospirenone (DRSP) seems to have a favorable effect on blood pressure (BP);~     however, when associated with ethinylestradiol (EE), this effect does not seem to occur. This~     study has the objective to assess possible differences in BP associated with the use of COCs~     containing DRSP with different doses of ethinylestradiol.~      Materials and methods: This open-label parallel-group randomized clinical trial involved~     women randomized to use either 30 mcg of EE+DRSP (n=22) or 20 mcg of EE+DRSP (n=22). Daytime,~     nighttime and 24-hour BP were evaluated by ambulatory blood pressure monitoring (ABPM) at the~     beginning of the trial and six months after drug therapy.~   "
93592|NCT02342080|"~     Patients with incomplete spinal cord injury~   "
93593|NCT02342067|"~     A single center, open-label, fixed sequence study to evaluate the pharmacokinetics (PK) of~     Cenicriviroc (CVC) administered with and without Pioglitazone (PGZ), and to evaluate the PK~     of PGZ administered with and without CVC.~   "
93604|NCT02341924|"~     The objective of this research project is to investigate the ability to affect cardiovascular~     disease (CVD) risk factors through a novel, easily implemented functional food-based~     approach. The goal of the proposed project is to evaluate the effect of a range of~     proprietary products specifically formulated to deliver convenient pre-packaged~     condition-specific foods to positively impact blood cholesterol levels in statin intolerant~     and/or statin unwilling participants. The specific aim of this project is to evaluate the~     changes in serum low-density lipoprotein (LDL)-cholesterol, triglyceride (TG) glucose,~     insulin and high-sensitivity C-reactive protein (hsCRP) concentrations over a 4 week regimen~     using healthy tasty foods which are self-selected by a statin intolerant patient group.~   "
93594|NCT02342054|"~     High-dose rate brachytherapy (HDR-BT) is an advanced technology theorized to be more~     advantageous than LDR-BT and External Beam Radiotherapy (EBRT), to the patient himself, and~     in terms of resource allocation. Studies of HDR-BT monotherapy have encouraging results in~     terms of biochemical control, patient survival and toxicity, but there are still certain~     limitations that preclude recommending HDR-BT monotherapy outside the setting of a clinical~     trial.~      The primary endpoint of this study is to evaluate the safety, tolerance and impact on quality~     of life (QoL) of the BT-HDR 19Gy administered in single fraction in patients with low and~     intermediate risk prostate cancer. Secondary endpoint is to measure the efficacy, in terms of~     cancer control and satisfaction of the patients undergoing the experimental treatment.~      Forty nine patients will be recruited for the experimental procedure Quality of Life,~     tolerance, gastrointestinal and genitourinary toxicity will be assessed using standardized~     procedures and scales. Patient satisfaction with the procedure will be appraised using~     five-category predetermined Likert scale questions.~      Two different types of intermediate analyses will be performed: with 15 and 30 recruited~     patients.~      The experimental treatment tested in this study is very innovative. Since prostate cancer is~     the most frequent cancer in men in Spain, this trial results are very likely to have a major~     impact on the standard therapy for prostate cancer in our National Health Service, allowing~     for a higher number of Hospitals within our country and other countries starting protocols of~     HDR BT 19Gy in single fraction.~   "
93595|NCT02342041|"~     The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of~     SUVN-G3031 in healthy male subjects following single or multiple ascending doses.~   "
93596|NCT02342028|"~     To compare the number and function of regular T cell of patients with obstructive sleep apnea~     (OSA) versus that of age-, gender- and BMI (body mass index)-matched controls~   "
93597|NCT02342015|"~     Background: Circulating osteoprogenitors and RANKL expression in immune cells have been~     implicated in the pathogenesis of osteoporosis and vascular calcification. The role played by~     statin therapy in the bone-vascular axis is unknown.~      Methods: Twenty naïve post-menopausal osteoporotic hypercholesterolemic women will be treated~     with Atorvastatin 40 mg/day for three months. Blood samples will be collected at baseline and~     at the end of the treatment. Gene expression analysis will be performed to assess~     modification in OPG/RANK/RANKL expression in isolated T-cells and monocytes. A flow cytometry~     analysis will be used to study changes in the levels of circulating osteoprogenitor cells.~   "
93598|NCT02342002|"~     The purpose of the proposed study is to compare - in a randomized, placebo-controlled,~     double-blinded trial - a combination of mifepristone and misoprostol to misoprostol used~     alone for missed abortion.~   "
93599|NCT02341989|"~     One course of adjuvant carboplatin AUC7 is considered internationally to be a standard~     treatment option in clinical stage I seminoma, regardless of risk factors. Treatment is based~     on a large, randomized phase III study comparing adjuvant carboplatin with adjuvant~     radiotherapy. This study was done without registering data on possible risk factor for~     relapse. The relapse rate following carboplatin was in this study estimated to be 5.3 %. Data~     from a prospective, risk-adapted Spanish study showed that patients without risk factors had~     a very low risk of relapse, even without adjuvant treatment. This result is also confirmed by~     a recent analysis of SWENOTECA VII data, showing that this group of patients has a risk of~     relapse of less than 5 % without adjuvant treatment.~      Combined data from SWENOTECA V and VII studies indicate a high risk of relapse in patients~     with one or two risk factors (tumor 4 cm, stromal invasion of rete testis) treated with one~     course of adjuvant carboplatin. The relapse rate in this group of patients was 9.4 %,~     indicating a very modest effect of one course of adjuvant carboplatin. If adjuvant~     chemotherapy is the preferred treatment strategy, more potent chemotherapy regimens should be~     explored in this patient group. The results from SWENOTECA III/VI studies with one course of~     cisplatin-based adjuvant chemotherapy in clinical stage I nonseminoma, show a very low rate~     of relapse. As seminoma is even more chemosensitive than nonseminoma the relapse rate~     following one course of adjuvant BEP is expected to be very low, close to 1 %.~      The overall aim is to investigate whether one course of adjuvant BEP have a lower relapse~     rate than one course of adjuvant carboplatin AUC7. In addition, it will be investigated if~     there is a difference in health related quality of life as well as acute and long-term~     toxicities from treatment.~   "
93600|NCT02341976|"~     To study which position on the whole body vibrator machine would stimulate the pelvic floor~     muscles.~   "
93601|NCT02341963|"~     The purpose of this pilot study is to test the safety of oral ketamine to treat acute pain~     after amputation surgery. The objective of the proposed research is to conclusively determine~     if oral ketamine is a safe alternative analgesic to opioid for acute pain in subjects~     undergoing elective amputation of the lower extremity. All participants will receive oral~     ketamine.~   "
93602|NCT02341950|"~     This study will evaluate the efficacy of a newly developed serious game, SCI HARD, to enhance~     self-management skills, self-reported health behaviors, and quality of life among adolescents~     and young adults with spinal cord injury and disease (SCI/D). SCI HARD was designed by the~     project PI, Dr. Meade, in collaboration with the UM3D (University of Michigan three~     dimensional) Lab between 2010 and 2013 with funding from a NIDRR (National Institute on~     Disability and Rehabilitation Research) Field Initiated Development Grant to assist persons~     with SCI develop and apply the necessary skills to keep their bodies healthy while managing~     the many aspects of SCI care. The study makes a unique contribution to rehabilitation by~     emphasizing the concepts of personal responsibility and control over one's health and life as~     a whole. By selecting an innovative approach for program implementation, we also attempt to~     address the high cost of care delivery and lack of health care access to underserved~     populations with SCI/D living across the United States (US).~      H1: SCI Hard participants will show greater improvements in problem solving skills, healthy~     attitudes about disability, and SCI Self-efficacy than will control group members; these~     improvements will be sustained over time within and between groups.~      H2: SCI Hard participants will endorse more positive health behaviors than control group~     members; these improvements will be sustained over time within and between groups.~      H3: SCI Hard participants will have higher levels of QOL than control group members; these~     differences will be sustained over time within and between groups.~      H4: Among SCI Hard participants, dosage of game play will be related to degree of change in~     self-management skills, health behaviors and QOL.~   "
93603|NCT02341937|"~     Patients with cancer have a high risk of deep vein thrombosis which often develops in the~     veins of the lower limbs. The initial evaluation of clinically suspected deep vein thrombosis~     includes the estimation of the clinical probability by calculating risk scores such as the~     Wells score and the measurement of the D-dimer. However, the usefulness and accuracy of the~     clinical scores and d-dimer test are lower in patients with cancer who often undergo~     unnecessary (serial) ultrasonography.~      The aim of the current study is to analyze variables that predict the presence of thrombosis~     and may improve the accuracy of the Wells score. In addition, various cut-off of the d-dimer~     will be evaluated with the goal of improving the sensibility and specificity of the test.~   "
93606|NCT02341898|"~     Background: Physical restraints as bedrails and belts are still regularly applied in German~     nursing homes despite clear evidence showing their lack of effectiveness and safety. In a~     cluster-randomized controlled trial, the efficacy of a guideline-based multicomponent~     intervention has been shown with a significant reduction in physical restraints use without~     adverse events. The present study aims to apply different versions of the original~     intervention in nursing home residents in four different regions throughout Germany in order~     to evaluate the effectiveness of the programme.~      Methods/Design: Pragmatic cluster-randomized controlled trial comparing two intervention~     groups ((1) updated original programme and (2) brief version of the updated programme) with a~     control group (3) receiving printed study materials (optimized usual care). Intervention (1)~     consists of an information programme for all nurses, additional training and structured~     support for nominated key nurses, and provision of printed study material and other~     supportive material. For intervention (2) nurses' training is only optional carried out~     facultatively by key nurses who have received an additional train-the-trainer module. The~     control group (3) receives printed study material only. Overall, 120 nursing homes including~     approximately 10800 residents will be recruited, randomized to one of the three groups and~     followed up for 12 months. The primary outcome is defined as proportion of residents with at~     least one physical restraint at 12 months. Physical restraint use will be assessed by direct~     observation. Secondary outcomes are residents` quality of life as well as safety parameters~     as i.g. falls and fall-related fractures. Process and cost measures will also be assessed.~   "
93607|NCT02341885|"~     A prospective international, multi-centre, prevalence study on the epidemiology of the use of~     renal replacement therapy for ICU patients who have acute kidney injury and chronic end stage~     kidney disease.~   "
93608|NCT02341872|"~     The purpose of this study is to determine whether Fluoride varnish + calcium (Clinpro White~     Varnish) and polipeptide solution (Curodont Repair) are effective in the treatment of~     remineralization therapy. The investigators will diagnose their alone or in combination~     effects on white spot lesions. Aesthetics (tooth-colored), remineralization, microbiological~     effects will be evaluated separately. Spectrophotometer (Vita Easy Shade) , Quantitative~     Light Fluorescence (QLF), Diagnodent(Cavo Diagnodent) and culture methods in microbiology~     laboratories are used for aesthetic, remineralization and microbiological assessments. The~     measurements will be made baseline, 6 weeks, 3 months and 6 months later after the~     applications and recorded.~   "
93609|NCT02341859|"~     Lens Fitting Evaluation of CooperVision MyDay™ Compared with 1-DAY ACUVUE® TruEye® and~     DAILIES TOTAL1®~   "
93610|NCT02341846|"~     This interview and focus group study will explore patient, caregiver, and health professional~     opinions about the potential roles of digital technology to support effective cancer pain~     management. The views, opinions, and ideas expressed in this study will be used to design and~     develop a digital intervention which is likely to take the form of a measurement (pain and~     analgesic use) guided medication management intervention to improve cancer pain management in~     the community.~   "
93611|NCT02341833|"~     The aim of the investigators study is to investigate the effects of anaesthetic~     preconditioning with sevoflurane during organs harvesting in brain dead donors. More~     particularly, the investigators will investigate whether sevoflurane preconditioning protects~     against ischaemia-reperfusion the livers and kidneys allografts after a prolonged period of~     cold ischaemia and whether this protection translates in a better clinical functional~     recovery of these allografts.~   "
93612|NCT02341820|"~     This project which is fully funded by the European Union FP7 Program is designed to pull~     together all the information we obtain from scans and x-rays to design a personalised 3-D~     digital model of each patient, their anatomy and disease. We can then use this as follows: as~     (i) an aid to surgical planning to enable objective clinical decision making (ii) a decision~     support tool to communicate the available treatment options to the patient and facilitate~     shared decision making and provision of personalised care and (iii) to enable standardised~     objective evaluation of the aesthetic outcome of the treatment procedures. This study aims to~     demonstrate the ability of the Virtual Physiological Human concept to empower breast cancer~     patients and assess the impact on their care and quality of life.~   "
93613|NCT02341807|"~     This clinical study evaluates the safety and tolerability of AAV2-hCHM in subjects with~     Choroideremia gene mutations. Two dose groups will be evaluated.~   "
93614|NCT02341794|"~     The purpose of this study is to investigate the effects of rosuvastatin treatment on degree~     of intracranial arterial stenosis.~   "
93615|NCT02341781|"~     The objective of this study is to determine the effectiveness of lenalidomide in subjects~     with relapsed or refractory Mantle Cell Lymphoma (MCL) following ibrutinib treatment. MCL~     subjects who require treatment after receiving ibrutinib therapy are considered a population~     with high unmet medical need. It is therefore of benefit to have data on the outcomes of~     treatment options available in this patient population.~      An observational study design was chosen to collect the clinical data already existing or~     being collected for MCL subjects being treated with lenalidomide.~      MCL subjects who received lenalidomide either as monotherapy or as combination treatment~     after having relapsed or progressed on ibrutinib treatment or were refractory or intolerant~     to ibrutinib treatment are eligible for the study. Lenalidomide does not need to be the next~     subsequent treatment after ibrutinib.~   "
93616|NCT02341768|"~     The primary requirement of the implantable cardioverter defibrillator (ICD) is to preserve~     life by terminating life-threatening arrhythmias (VT/VF). The treatment options vary in terms~     of techniques and medical devices, based on the patient's condition.~      It is extremely important in the clinical practice to identify which patients' subgroup~     benefits the most from the ICD therapy, which comorbidity has a major impact on the patients'~     prognosis, or which pre-intra-post procedural behaviors provoke less complications, and~     affect the patient's outcome (including prolonged or unwanted hospitalizations).~   "
93617|NCT02341755|"~     This study aims to evaluate the accuracy of dual energy computerized tomography (DE-CT) in~     predicting the need for surgery in patients with Crohn's disease and intestinal lesions with~     obstructive symptoms.~      Patients with known Crohn's disease which were scheduled to perform abdominal CT for~     obstructive symptoms preformed it in a dual energy protocol and then followed for an outcome~     of surgery. DE-CT parameters were then compared between patients who underwent surgery and~     those who did not.~   "
93619|NCT02341729|"~     The first aim of the study is to prove that after starting the therapy with crushed tablets,~     the platelet inhibition will be as expected after starting therapy with intact tablets.~     Gurbel et al. showed that 100% of the patients on ticagrelor treatment have a decrease from~     baseline platelet aggregation of >10% 4 hours after last maintenance dose. So the~     investigators expect that after 3 days of treatment, all of our patients will have a closing~     time of more than 106seconds.~      The investigators will observe two different clinical conditions of Acute Coronary Syndrome.~     First after semi-urgent coronary artery bypass graft (CABG) surgery, secondly in patients~     after cardiac arrest.~      Both are clinical situations in which crushed tablets are needed to give. The second~     objective is to determine plasma concentrations of Ticagrelor and AR-C124910XX (active~     metabolite of ticagrelor) in these two patient populations after receiving 180mg or 90mg~     start-dose. Determination of plasma concentrations is done after protein precipitation, by~     using liquid chromatography with mass spectrometry detection. Measurements will be determined~     before intake (0h) and at 0,5; 1; 2; 4; 8; 24h and at day 4 +4h.7 The first 24h this will be~     a crushed tablet and 4 hours after the first intake at day 4 of therapy, this will be a non~     crushed tablet.~   "
93620|NCT02341716|"~     The purpose of this randomized clinical trial is to determine and compare the clinical and~     cost effectiveness of three methods for exercise therapy as treatment for patients with~     intermittent claudication. The methods tested are a hospital-based (SET) and a home-based~     (HET) supervised exercise program and unsupervised walk advice (WA) and all patients are~     followed for 12 months. Unsupervised WA consists of advice of at least 30 minutes walking~     with Nordic Poles (NP) at least three times per week and this basic treatment, including best~     medical treatment, is used in all three treatment groups. In addition to this basic~     treatment, the SET group patients during the first six months participate in group-based~     exercise therapy in the hospital for 50 minutes three times weekly, supervised by a~     physiotherapist. The HET group patients perform the same exercise in their home 50 minutes~     three times weekly during six months receiving feedback from a physiotherapist by a phone~     call every 14th day. The SET and HET group patients are recommended to continue the 50~     minutes three times weekly exercise therapy in their homes without supervision during the~     last six months. Primary outcome is change from baseline to 12 months in walking distance~     during six minutes in a hospital corridor (6MWT) and co-primary outcome is change from~     baseline to 12 months in health-related quality of life (HRQoL) using the SF36 questionnaire.~     Secondary outcomes include fulfillment of patient-specified goals with treatment (PSFS),~     change in health-related quality-of-life (HRQoL) with a disease-specific instrument~     (VascuQoL), walking impairment as measured by the Walking Impairment Questionnaire, physical~     activity (accelerometer) and compliance with physical exercise therapy (patient diary).~   "
93621|NCT02341703|"~     Polycystic ovary syndrome (PCOS) affects 5-10% of women in childbearing age. Hyperinsulinemia~     contributes to chronic anovulation commonly encountered in women with PCOS. The first choice~     therapy is clomiphene citrate (CC). In CC resistant cases, the American College of Obstetrics~     and Gynecology (ACOG) recommends the use of insulin sensitizer metformin. Other insulin~     sensitizing agents include rosiglitazone and pioglitazone. Pioglitazone is said to improve~     fertility and ovulation in patients with PCOS.CC may be associated with poor endometrial~     thickening due to its antiestrogenic effect. Letrozole may improve this condition. In this~     study we will compare the effect of combined letrozole-metformin with that of combined~     letrozole-pioglitazone in ovulation induction in CC-resistant PCOS women~   "
93622|NCT02341690|"~     Type 2 Diabetes (T2D) is one of the most common chronic diseases world vide. Patients with~     T2D experiences reduced quality of life and have a lower physical activity level. Physical~     activity is well documented treatment to the patient group. The effect of physical activity~     is shown to reduce co-morbidity, and better functional level and quality of life.~      Interval Walking Training (IWT) is a new and effective exercise type. IWT is done by walking~     in a slow and a fast tempo. InterWalk is an application to a smartphone. By using InterWalk~     the patient can to IWT independently and when used, the app has, as an exercise tool, the~     potential to better the individual functional level and to measure the physical activity~     level with the integrated personalised walking test.~      Motivation for change of habits and lifestyle is subjectively determined by the individual,~     his or hers individual resources and environment. It is important to get insight in these~     individual challenges in order to be better structure possible help.~      The combination of an exercise log, a measure of physical activity fromInterWalk and insight~     in motivational aspects on an individual level, is essential for successful individualised~     training.~      The primary objective of the study is to investigate if the InterWalk app is more effective~     in increasing the physical activity level compared to a standard care offer in a sample of~     newly T2D diabetes patients across 52 weeks.~      Secondarily, we will investigate if the IW app can reduce sitting time, induce weight loss,~     improve glycaemic control, increase quality of life, improve cardio-respiratory fitness and~     reduce the use of diabetes medication.~      The study is designed to test the hypothesis that replacing a standard exercise program in~     the normal municipal standard care with the Interval Walking Training delivered by the IW app~     with and without a motivational support program, can increase the long-term physical activity~     level in patients with T2D for a period of 52 weeks.~      From January 2015 to June 2016 all patient's with T2D, who are referred to the promotion~     centres in the municipality, will be offered to participate in the study. In total 513~     patients with T2D from different municipalities in Denmark will be included and randomly~     allocated into three groups. One group will receive standard care and the two other groups~     will do IWT with the InterWalk app. All three groups are followed by the promotion centre for~     8-14 weeks (according to the rehabilitation in the municipality) and hereafter only one of~     the IWT groups will receive motivational support up to 52 weeks.~      All patients, no mater group allocation, will be tested and fulfill questionnaires, three~     times during the intervention period - at baseline, after 8-14 weeks and after 52 weeks. The~     interventions take place at the promotion centres in the municipalities two times a week and~     the patient will be encouraged train by them selves one time a week.~   "
93623|NCT02341677|"~     The purpose of this study is to determine how well SmartTarget guided prostate biopsies~     perform, compared with our current standard of visually directed biopsies in the detection~     of prostate cancer.~      The diagnosis of prostate cancer is dependent upon sampling the prostate to confirm disease.~     Standard trans-rectal biopsies are taken in a random fashion, without prior knowledge of the~     disease location. Transperineal mapping biopsies overcome this by systematically samples the~     entire gland but are very intensive and time consuming to perform.~      An alternative method is to perform targeted prostate biopsies where an MRI prior to biopsy~     can be used to inform doctors about the location of the disease. This is a difficult~     procedure to perform as it requires the surgeon to mentally translate the location of disease~     on MRI image to the live ultrasound seen in theatre.~      SmartTarget may help this procedure by providing guidance to the location of the disease by~     fusing the MRI image onto the live ultrasound, thereby providing the clinician a target to~     biopsy.~      This trial will compare the outcomes of visually directed biopsies with those directed by~     SmartTarget~   "
93663|NCT02341157|"~     This is a two-step observational cohort study evaluating the impact of adding PikoLogic® to~     the current disease management COPD discharge protocol subsequent to an admission for COPD~     exacerbation.~   "
93625|NCT02341651|"~     High blood pressure (BP) is the leading attributable risk for cardiovascular disease (CVD).~     In rural South Asia, hypertension remains to be a significant public health issue with~     sub-optimal rates of case finding and management. A trial to investigate integrated primary~     care strategies to control hypertension is planned. Packaged interventions for the planned~     full-scale study are varying combinations of 1) home health education (HHE) by trained~     community health workers (CHW), 2) trained government primary health centre mid-level~     providers (MLP) led care and 3) trained private practitioners. The goal of the full-scale~     study is to test which combination of the above interventions is the most effective in~     lowering blood pressure among adults with hypertension in rural communities. In addition, the~     full-scale study aims to quantify the incremental cost- effectiveness of each approach in~     terms of cost per projected cardiovascular disease (CVD) disability adjusted life-years~     (DALYs) averted.~   "
93626|NCT02341638|"~     The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and~     pharmacodynamics (PD) of a single and multiple oral doses of BMS-986141 in healthy subjects.~   "
93627|NCT02341625|"~     The purpose of this study is to determine the safety, tolerability, pharmacokinetics,~     immunogenicity, antitumor activity and pharmacodynamics of BMS-986148 administered alone and~     in combination with nivolumab in patients with mesothelioma, non-small cell lung cancer,~     ovarian cancer, pancreatic cancer and gastric cancer.~   "
93628|NCT02341612|"~     Subjects were randomly placed in five groups: (1) single exposure at 5°C in cold water~     immersion, (2) single exposure at 15°C in cold water immersion, (3) multiple exposures at~     10°C in cold water immersion, (4) whole body cryotherapy (WBC) at 110°C and (5) passive~     recovery (control group). The single exposure groups performed cold water immersion~     immediately after exercise-induced muscle damage (EIMD) for 20 minutes. The multiple~     exposures group performed cold water immersion immediately, 24h, 48h and 72h after EIMD (once~     a day) for 20 minutes. The WBC group remained in the cabin immediately after EIMD for 3 min.~     The control group was not exposed to treatment after the EIMD protocol. The subjects were~     asked to visit the laboratory on seven occasions. The first visit was the familiarization of~     the subjects with experimental procedures and their anthropometric assessment. One week after~     familiarization, on visit two, volunteers performed the exercise-induced muscle damage (EIMD)~     protocol and they were allocated to one of experimental groups. Indirect markers of muscle~     damage and inflammatory responses were evaluated at baseline (pre), immediately post, 24h,~     48h, 72h, 96h, and 168h following the EIMD protocol by measuring anterior thigh muscle~     swelling, isometric knee extensors peak torque, knee extensors muscle soreness,~     countermovement vertical jump and blood sample analyzes.~   "
93629|NCT02341599|"~     The purpose of this study is to characterize the effect of renal function on the plasma,~     urine, and dialysate pharmacokinetic profile of CB-238,618 in humans. The study will also~     assess the safety profile and tolerability of CB-238,618 in subjects with varying degrees of~     renal impairment and in healthy subjects.~   "
93630|NCT02341586|"~     The purpose of this research is to determine if cooking with an iron ingot called the Lucky~     Iron Fish (LIF) increases the hemoglobin status in women of childbearing age living in Preah~     Vihear, Cambodia. The investigators hypothesize that the use of the LIF during cooking over a~     12-month period will be as efficacious at increasing hemoglobin concentration as iron~     supplements (18 mg elemental iron) and will be more efficacious than the control.~   "
93631|NCT02341573|"~     The purpose of this study is conducting a randomized, single blind, controlled intervention~     trial to observe the therapeutic effect of experienced chinese herbal formulas based on~     different stages and different symptoms in pediatric asthma.~   "
93632|NCT02341560|"~     This study will determine the effect of QPI-1007 on visual function in subjects with~     recent-onset NAION and assess the safety and tolerability of intravitreal injections of~     QPI-1007 in this population. This study will also evaluate the structural changes in the~     retina following administration of QPI-1007.~   "
93633|NCT02341547|"~     This is a prospective, observational, non-inferior study in ESRF patients stable on Eprex who~     are switched to a Biosimilar Epoetin Alfa. Study plans to recrut 44 patients. Following~     recruitment, a baseline data collection of full routine laboratory test before switch to~     Binocrit.Primary endpoint is Mean change in haemoglobin levels at 12 weeks and Secondary~     endpoint is Mean change in haemoglobin levels at 6 weeks Safety endpoint will be Adverse drug~     reactions and serious adverse effects Analysis: Changes from baseline at Week 6 and Week 12~     will be evaluated using paired t-test or Wilcoxon signed ranks test as appropriate. Changes~     in continuous variables over time were evaluated using repeated-measures analysis of~     variance. Patients with iron-deficiency (ferritin <100 ng/ml or transferrin saturation <20%)~     will be analysed separately~   "
93634|NCT02341534|"~     The BIO|GUARD-MI study investigates whether continuous arrhythmia monitoring and the~     consequent treatment after detected arrhythmias in patients after acute myocardial infarction~     with preserved cardiac function, but other risk factors, decreases the risk of major adverse~     cardiac events.~   "
93635|NCT02341521|"~     An open label study in 9 male and 9 female healthy subjects to determine the pharmacokinetics~     of parent compound and metabolite after eight days of dosing.~   "
93636|NCT02341508|"~     The primary purpose of this study is to evaluate the safety and tolerability of Lpathomab in~     healthy volunteers. Additional endpoints include characterization of the pharmacokinetic~     (PK), pharmacodynamic (PD), and immunogenicity profiles of a single IV dose of Lpathomab in~     healthy volunteers.~   "
93637|NCT02341495|"~     The purpose of this study is to find out if by giving a combination of 3 drugs the leukemia~     will go into complete remission (meaning the leukemia is completely gone), and to find out~     how long it stays away. The drugs used in this project are FDA approved and commercially~     available.~   "
93638|NCT02341482|"~     The purpose of the current study is to characterize the pharmacokinetic (PK) profile of PF~     04958242 when co administered with a strong cytochrome P450 3A4 (CYP3A4) inhibitor.~   "
93677|NCT02340975|"~     This is a randomized, multicenter, open-label, dose-exploration and dose-expansion study to~     evaluate the safety, tolerability, antitumor activity, PK, pharmacodynamics, and~     immunogenicity of MEDI4736 in combination with tremelimumab, MEDI4736 monotherapy or~     tremelimumab monotherapy in subjects with metastatic or recurrent gastric or gastroesophageal~     junction adenocarcinoma~   "
93639|NCT02341469|"~     In 2010, one in six children in Burkina Faso died before the age of five, mainly due to lack~     of access to quality health care services. Most of these deaths could have been avoided~     through cost-effective interventions. Ensuring that sick children receive adequate care in a~     country where 80% of the population lives in rural areas requires improved accessibility and~     high quality primary health care services. The Integrated Management of Childhood Illnesses~     strategy (IMCI) was developed by the World Health Organization (WHO) and the United Nations~     Children's Fund (UNICEF) in the 1990s and is an excellent way to improve the quality of~     country's child health services. However, in Burkina Faso IMCI suffers from a low level of~     adherence by health workers. According to a recent evaluation by the Ministry of Health~     (MoH), only 8.2% of children had benefited in 2012 from an consultation using IMCI guideline.~     Moreover, an analysis of children's records showed that only 15% of IMCI consultations were~     being correctly delivered and, for instance, only 34% of children with pneumonia who needed~     an antibiotic were prescribed the correct treatment. The obstacles to IMCI adoption in~     Burkina Faso are diverse and include inadequate training methods, shortage of material~     (papers, forms), lack of quality supervision by district executive teams, lack of integration~     between IMCI monitoring tools and the national health information system etc.~      The Integrated eDiagnosis Approach (IeDA) aims to address the poor quality of child health~     services in Burkina Faso by increasing the level of adherence to IMCI guidelines. IeDA is an~     innovative strategy combining information and communication technologies (using the Registre~     Electronique des Consultations [REC], an electronic IMCI patient record designed by Terre des~     hommes, Tdh) and a quality improvement approach. The approach has been piloted over three~     years in two different districts in the north of Burkina Faso, Tougan and Séguénéga. This~     medium scaling-up demonstration project will combine implementation and research components~     with a goal to enable national scaleup.~      Terre des hommes is in charge of the implementation of the project and the London School of~     Hygiene and Tropical Medicine (LSHTM) will coordinate the research component of the study in~     partnership with Centre Muraz.~      The primary hypothesis is that the Integrated eDiagnosis Approach will lead to improved~     adherence to IMCI guidelines and management of childhood illnesses in two regions (with a~     target of 75% of correct diagnoses and prescriptions).~   "
93640|NCT02341456|"~     This is a phase Ib, open-label, multicentre study of AZD1775 administered orally in~     monotherapy and in combination with carboplatin and paclitaxel to Asian patients with~     advanced solid tumours.~   "
93641|NCT02341443|"~     Mandibular fractures represent approximately 50% of the total facial fractures and are~     commonly (more than half) presented in more than one location. A few simple fractures can be~     treated using a conservative approach. More often, however, mandibular fractures require~     stabilization using open reduction and internal fixation.~      Simple mandibular fractures can be treated using non-rigid fixation techniques that rely on~     the load-sharing principle, by which stabilization is accomplished with both fixation devices~     and bone surfaces. On the other hand, more complex fractures with continuity defects or~     comminuted need to be handle using rigid fixation where the device assumes all the forces~     (load-bearing principle). These approaches are well established, whereas the level of~     evidence for the treatment of bilateral double mandibular fractures (DMF) is still scarce. In~     fact, which surgical treatment, or combination of treatments, leads to the best outcome and~     the lowest rate of complications in bilateral DMFs is an open question.~      The purpose of this study is to assess the complication rate in patients suffering from~     bilateral DMF treated either using non-rigid fixation on both fracture sides or a combination~     of rigid fixation on one side and non-rigid fixation on the other side.~   "
93642|NCT02341430|"~     This study is being done to test the efficacy of Symbotex™ as an effective synthetic mesh~     option in the repair of grade I and II ventral hernias.~   "
93643|NCT02341417|"~     The primary objective of this study was to characterize the long-term safety and tolerability~     of cinacalcet in pediatric patients with chronic kidney disease (CKD) receiving dialysis.~   "
93644|NCT02341404|"~     The primary aim of the study was to characterize and quantify the histopathological changes~     in the surgical specimens obtained in patients undergoing prostatectomy in addition to~     imaging changes (MRI) following a single injection of Liproca Depot in patients with~     localized prostate cancer.~   "
93645|NCT02341391|"~     The primary purpose of the this study is to evaluate the safety of TissueGene-C, a gene~     therapy product that uses allogenic human chondrocytes expressing Transforming Growth~     Factor(TGF)-β1 by assessing the inflammation at the injection site, the incidence and~     severity of the adverse events, the physical examination findings, and the laboratory test~     results after the intra-articular injection of TissueGene-C.~      And Secondary purpose is to evaluate the biological efficacy (knee pain, range of motion,~     functional tests, and MRI) of TissueGene-C and the distribution of TissueGene-C outside the~     injection site.~   "
93646|NCT02341378|"~     To assess the efficacy and safety of the intra-articular injection of TissueGene-C in~     patients with degenerative arthritis of the knee~   "
93647|NCT02341365|"~     Objective: To investigate the correlation between total and bioavailable serum 25-OH vitamin~     D, ovarian reserve and ovarian response to controlled stimulation in egg donors.~   "
93648|NCT02341352|"~     Analysis different measures preventive effect on carious Lesions incidence and oral~     microecological system change of preschool children~   "
93649|NCT02341339|"~     Prospective Feasibility Study:~      Fallopian tube cells will be obtained from patients undergoing laparoscopic surgery during~     their surgical evaluation of infertility. Of note, these patients are already scheduled to~     undergo surgery as part of their standard of care.~   "
93650|NCT02341326|"~     Early changes associated with the development of smoking-induced diseases, e.g., COPD and~     lung cancer (the two commonest causes of death in U.S.) are often characterized by abnormal~     airway epithelial differentiation. Airway basal cells (BC) are stem/progenitor cells~     necessary for generation of differentiated airway epithelium. Based on our preliminary~     observations on SAE BC cells and FGFR2 signaling, we hypothesized that suppression of FGFR2~     signaling in the SAE BC stem/progenitor cells by cigarette smoking renders these cells less~     potent in generating and maintaining normally differentiated SAE, shifting these cells~     towards a COPD associated phenotype. To test this, SAE basal cells will be isolated from~     cultured cells obtained through bronchoscopic brushings and analyzed through in vitro assays~     for their stem/progenitor capacities.~   "
93651|NCT02341313|"~     Low blood sugar levels are common in babies after birth. This may be normal as babies can use~     other sources of energy. However if a baby does not produce these fuels the brain can be~     starved of energy and be damaged. Measurement of these fuels is not done as part of clinical~     practice in the newborn. We aim to see whether at the same time as taking the blood sugar~     level from a heel prick we can measure these fuels in a small drop of blood. At the same time~     as blood needs to be taken for clinical reasons we want to take a drop of blood from 50~     babies to see how good the point of care (POC) meters are compared to the laboratory at~     measuring these fuels. If accurate these POC meters could identifying those at risk from~     brain damage as well as prevent separation of mothers and babies who are establishing breast~     feeding.~   "
93652|NCT02341300|"~     Anemia of pregnancy is defined as a hemoglobin concentration of less than 11 g/dL in the~     first and third trimesters, and less than 10.5 g/dL in the second trimester. The rates of~     anemia are variable and depend largely on preexisting iron stores and supplementation.~     Estimates from the World Health Organization report that 35% to 75% of pregnant women in~     developing countries and 18% of women from industrialized countries are anemic. Maternal~     anemia is associated with an increased risk of preterm birth, low birthweight, and small for~     gestational age infants. Many studies have shown improvement in these outcomes with maternal~     iron supplementation in cases of iron-deficiency anemia. Mounting evidence also indicates~     that maternal iron deficiency in pregnancy reduces fetal iron stores, perhaps well into the~     first year of life.~      Anemia in pregnancy can also impact maternal morbidity and mortality. Viteri reported that~     anemic pregnant women are at greater risk of death during the perinatal period and that~     anemia is the major contributory or sole cause of death in 20-40% of the 500,000 maternal~     deaths per year.~      The need for iron averages close to 1000mg in a typical singleton gestation. This amount~     considerably exceeds the iron stores of most women and will result in iron-deficiency anemia~     unless supplemental iron is taken. One problem with iron supplement use is compliance,~     secondary to adverse effects such as constipation and nausea. Research on the use of cast~     iron pots in decreasing the incidence of iron-deficiency anemia in non-pregnant women has~     been promising. These studies have demonstrated good compliance with no reported adverse~     effects. The aim of our study is to determine if providing anemic women in the first~     trimester of pregnancy with a cast iron pot will decrease the incidence of anemia later in~     pregnancy.~      Hypothesis: Cooking in cast iron pots will increase hematocrit levels in pregnancy.~   "
93653|NCT02341287|"~     The investigators plan to test the effectiveness of warm gel gloves in reducing the time it~     takes individuals to fall asleep (sleep latency). The investigators will have subjects track~     their sleep for two-weeks using both sleep logs and a small wristwatch-like monitor called an~     actigraph to measure the degree of the persons' difficulty falling asleep. It must take at~     least 30-minutes to fall asleep 3-days per week to qualify for the study. If a subject~     qualifies, they will wear the heated gel gloves or a placebo non-heated gel glove during~     sleep for two-weeks and sleep will be measured again using sleep logs and actigraphy. The~     baseline sleep latency data will be compared to the treatment period using a independent~     t-test. The investigators believe that wearing the warm gel gloves will reduce sleep latency.~   "
93654|NCT02341274|"~     Amorphous solid dispersion (ASD) formulations are increasingly used by the pharmaceutical~     industry to develop poorly water-soluble drugs into effective oral dosage forms. Examples~     include the antifungal drug itraconazole, the HIV protease inhibitor combination,~     lopinavir/ritonavir and the immunosuppressive, tacrolimus. There is potential for significant~     variation in bioavailability of ASD and thus heightened concern regarding the therapeutic~     efficacy as generic versions of these poorly water-soluble compounds become approved. The~     variation in bioavailability is to be expected because of our limited understanding of the~     precise physical chemistry of drug polymer amorphous solid dispersion formulations.~   "
93655|NCT02341261|"~     The proposed study will randomize participants with diabetic peripheral neuropathy into two~     groups. One group of participants will receive standard-of-care counseling while the other~     group will undergo supervised exercise and counseling to increase physical activity.~   "
93656|NCT02341248|"~     Exclusive Enteral Nutrition (EEN) is the liquid diet given to children with active Crohn's~     Disease (CD). EEN has previously been shown to induce changes in major bacterial metabolites~     and dominant bacterial species which are more profound in children that clinically improve.~     This study aims to determine whether it is possible to maintain these bacterial changes with~     prolonged supplementary enteral nutrition (SEN) while returning to normal diet and if this~     can reduce risk of subsequent relapse for children with CD.~      New technologies will allow measurement of a broad range of bacteria and metabolites, to test~     if the clinical response to EEN and changes in gut inflammation are associated with bacterial~     composition and chemical products; and if maintenance of changes using SEN reduces the risk~     of relapse over a 12 month period.~      The study will aim to recruit all potential Crohn's disease children coming to a tertiary~     paediatric centre for colonoscopy. Once consented, an initial blood, urine and faecal sample~     will be requested along with 8 mucosal biopsies during the routine endoscopy session. If~     diagnosed with CD, and if the clinician prescribes treatment with EEN, an additional blood~     sample will be requested at the end of EEN, and 5 faecal and urine samples spread over 12~     months; as well as some dietary information.~      Samples will be collected from up to 42 children with CD and 42 age- and sex-matched healthy~     volunteers. Initial samples taken from children who were not diagnosed with CD will be~     compared with CD samples to look for potential metabolic disease markers. Characterisation of~     faecal bacteria and metabolites in both faeces and urine; as well as measurement of blood~     inflammatory biomarkers will be performed.~   "
93657|NCT02341235|"~     The purpose of this study is to compare an enhanced intervention that includes narrative and~     game components to a standard intervention that only targets self-monitoring. These~     approaches will be tested among postmenopausal breast cancer survivors who are sedentary and~     overweight.~   "
93658|NCT02341222|"~     The Buckypaper (BP) is an innovative material that has attracted the attention of many~     research groups engaged in the study of its possible applications in various technological~     fields. Our purpose is demonstrate the viability of the application of nanotechnologies to~     the General Surgery in human with thwe use of a new self standing prosthetic device for the~     reconstruction of abdominal wall defects.~   "
93659|NCT02341209|"~     This study looks at the efficacy of Doxycycline for the treatment of Cutaneous T-cell~     Lymphomas.~   "
93660|NCT02341196|"~     This study examines the risk of thrombogenicity of the carotid patches in polyurethane~     compared to carotid patches in polyester including death, any stroke, carotid thrombosis at~     30 days and long-term results including stroke and recurrent carotid stenosis at 10 years.~      This study was run at the University of Roma, La Sapienza and at the University of Poitiers,~     randomisation was done in both enters after approval by the Ethical committee of the~     University of Roma (Record uploaded)~   "
93661|NCT02341183|"~     The primary objective of this study is to assess tolerability and effect of HS (hypertonic~     saline) delivered with the tPAD (transnasal Pulmonary Aerosol Delivery) device on mucociliary~     clearance (MCC) in chronic obstructive pulmonary disease/chronic bronchitis (COPD/CB)~     subjects. The investigators hypothesize that HS delivery via tPAD will be safe and and while,~     and will improve MCC.~   "
93662|NCT02341170|"~     The primary aim of this study is evaluate the impact of hippocampal-sparing prophylactic~     cranial irradiation (HS-PCI) on survival status in patients with nodal-positive (locally~     advanced) adenocarcinoma by comparing overall survival rates of patients undergoing HS-PCI to~     that of patients without this intervention. In addition, this study aims to investigate~     whether HS-PCI is detrimental on neurocognitive function and to evaluate its impact on the~     patient's quality of life.~   "
93664|NCT02341144|"~     This is a prospective, double-blinded, randomized controlled study comparing the efficacy of~     pre-incisional percutaneous rectus sheath block to intra-operative rectus sheath block under~     direct visualization prior to closure of the incision for providing post-operative analgesia~     following umbilical hernia repair in children. The current management for reducible umbilical~     hernias is umbilical hernia repair under general anesthesia as an outpatient procedure.~      Patients aged 3-18 years old with a diagnosis of umbilical hernia will be screened for study~     inclusion. Eligible patients and their parents/guardians will be approached and, if~     agreeable, consented for the study pre-operatively. Patients will be randomized to receive~     either pre-incisional percutaneous rectus sheath block by the anesthesiologist or~     intra-operative rectus sheath block under direct visualization prior to closure of the skin~     incision by the surgeon. The patient, patient guardians, select research team members, and~     post-anesthesia care unit (PACU) staff will be blinded to the method of analgesic~     administration.~   "
93665|NCT02341131|"~     The main objective of the study is to analyse the role of a neurotrophic factor (BDNF) as a~     putative biological marker of the cognitive recovery in schizophrenia following a Cognitive~     Remediation Therapy (CRT). Additionally, the role as outcome predictors of BDNF serum levels~     and the Val66met polymorphism and data from functional and structural neuroimaging will be~     studied.~   "
93666|NCT02341118|"~     BRCA1 or BRCA2 genes, are implicated in 10-15% of ovarian cancer cases, increased to 22%~     germline BRCA1/2 mutation frequency in patients with high grade serous histology subtype,~     including those women who have no family history of breast or ovarian cancer. With the rapid~     advancement of therapeutics targeted this population, this protocol seeks to provide genetic~     BRCA1/2 screening to all patients with high grade serous ovarian cancer. This information may~     help in selection of future treatment options and genetic testing for BRCA1/2 may be used to~     potentially prevent a proportion of cancer for the family members.~      This study will be an opportunity for patient to improve access at genetic and molecular~     testing for BRCA1/2 mutation which could impact her future treatment option. Moreover, this~     study will allow to prospectively assess the proportion of patients with BRCA mutation in~     ovarian cancer and describe the type of mutations identified in a large population.~   "
93667|NCT02341105|"~     Randomized trial of low-dose amiodarone therapy versus catheter ablation (CA) in older~     patients with persistent atrial fibrillation (AF).~      Primary Objective: To compare amiodarone to catheter ablation in patients aged 50 to 80 years~     with symptomatic AF for the composite outcome of hospitalization for cardiovascular cause or~     emergency department visit for atrial arrhythmia~   "
93668|NCT02341092|"~     Post-traumatic behavioral disorders : analysis and valuation of the expertise of use of the~     close friends of people victims of traumatic brain injury.~   "
93669|NCT02341079|"~     The purpose of the study is to evaluate the efficacy of local infiltration of liposomal~     bupivacaine versus use of an indwelling femoral peripheral nerve block in controlling early~     postoperative pain in primary total knee arthroplasty. The investigators hope to demonstrate~     equivalency of treatment modalities to provide an alternative to the commonly used treatment~     of femoral nerve blockade.~   "
93670|NCT02341066|"~     To evaluate the contribution of the assessment of endothelial dysfunction (ED) in improving~     coronary hearth disease (CHD) risk stratification obtained by the Framingham risk score (FRS)~     in rheumatoid arthritis population (RA).~   "
93671|NCT02341053|"~     Non-ambulatory children with a neuromuscular disability such as spinal muscular atrophy (SMA)~     are at significant risk for poor bone health as defined by low bone mineral density (BMD) and~     increased propensity to fracture. Poor bone health is thought to be related, at least in~     part, to abnormally low levels of load experienced by the skeleton. A common physical~     approach for increasing bone density is to stimulate the musculoskeletal system by increasing~     the amount and duration of weight-bearing in the lower extremities. For non-ambulatory~     individuals, this takes the form of using an assisted standing device to enable the child to~     spend time in a standing position with some degree of weight placed on the lower limbs. Some~     of these physical interventions demonstrate variable improvement in BMD in children with~     neuromuscular conditions, and some do not. A serious limitation in the previous work in this~     area is a failure to objectively measure the magnitude and duration of the loading~     experienced by the lower extremities. Thus, a lack of change in BMD may be due to the~     extremities experiencing only a fraction of the body weight (due to load-sharing with the~     assistive device) for an inadequate duration of standing time.~      In order to investigate the efficacy of standing treatment for increasing BMD, the~     investigators will develop a simple, portable and inexpensive transducer that will measure~     the magnitude and time course of the load experienced by the lower extremities of individuals~     with SMA who use a stationary assisted standing device. The specific goal of this proposed~     project will be to develop, validate and establish the initial feasibility of such a~     measurement device.~   "
93672|NCT02341040|"~     The goal of the study is to determine accurate blood test levels that can predict whether or~     not subjects are truly allergic to certain foods. In this study, subjects that are clinically~     documented to be wheat-allergic will participate in a double blind oral food challenge. Blood~     will be collected from the subject to evaluate the potential allergenicity of proteins~     introduced into genetically modified crops and evaluate wheat-specific immunoglobulin-e (IgE)~     antibody reactivity to biotech and conventional wheat varieties.~   "
93673|NCT02341027|"~     This study will evaluate if immediate postpartum placement of a levonorgestrel (LNG)~     contraceptive implant within 5 days of delivery improves implant utilization at 6 months~     postpartum compared to implant placement at 6-8 weeks postpartum among women in Uganda.~   "
93674|NCT02341014|"~     This is an open label phase Ib/IIa study of patients with relapsed/refractory B- and T-cell~     lymphomas who are treated with carfilzomib, lenalidomide and romidepsin in a 3+3 design. The~     phase IIa portion of the study will involve a dose expansion at the MTD to better~     characterize the efficacy and to inform further disease specific studies.~   "
93675|NCT02341001|"~     The purpose of this study is to determine whether text message support after discharge from a~     bariatric service improves outcomes following bariatric surgery.~   "
93676|NCT02340988|"~     The purpose of this study is to assess the drug interaction potential and time course of the~     effect of oritavancin on warfarin pharmacokinetics in an open label, single arm manner.~   "
93680|NCT02340936|"~     The purpose of the Phase I of the study is to evaluate the safety and the maximum-tolerated~     dose (MTD) of the combination R-ESHAP with lenalidomide as salvage therapy for patients with~     relapsed or refractory diffuse large B-cell lymphoma The purpose of the Phase II of the study~     is to evaluate ORR of LR-ESHAP in patients with relapsed or refractory DLBCL candidates to~     HDT and ASCT~   "
93681|NCT02340923|"~     The purpose of this protocol is to perform Electrical Impedance Myography (EIM) testing on~     healthy children and children with duchenne muscular dystrophy so as to develop a new,~     convenient tool for the office based assessment of children with a wide variety of~     neuromuscular conditions.~   "
93682|NCT02340910|"~     This study will enroll people with SCI who have spasticity and some ability to walk. The goal~     is to understand if standing on a platform and receiving WBV results in decreased spasticity~     and improved walking ability.~   "
93683|NCT02340897|"~     The aim of this study was to elucidate the accuracy and inter-rater agreement of diagnosis of~     nontuberculous mycobacterial lung disease based on chest computed tomography findings.~   "
93684|NCT02340884|"~     Study Title: A Pilot Randomized Controlled Trial of the Promoting Resilience in Stress~     Management (PRISM) Intervention for Adolescents and Young Adults with Cancer~      Study Population and Sample Size: Two cohorts of Adolescent and Young Adult (AYA) patients~     with diagnosis of new or recurrent cancer between 1 and 10 weeks prior to enrollment: those~     ages 13-17 (N=50); (2) those ages 18-25 (N=50).~      Study Design: Pilot randomized controlled trial (RCT).~      Primary Objective: To test the efficacy of the Promoting Resilience in Stress Management~     (PRISM) among Adolescents and Young Adults with cancer.~      Primary Outcome: Change in patient-reported resilience (based on score of standardized~     Connor-Davidson Resilience Scale) at 6 months.~      Secondary Outcomes:~        1. Patient-reported resilience at 2, 4, and 12 months~        2. Patient-reported self-efficacy, benefit-finding, psychological distress, quality of~          life, and health-behaviors at 6 and 12 months.~        3. Qualitative assessment of patient-reported goals at 6 and 12 months~        4. Development of a cohort of AYA cancer survivors for assessment of long-term psychosocial~          outcomes~      Study Duration: 3 years~   "
93685|NCT02340871|"~     In Israel, because of special qualification in neurogenetics, during a 30 year career ,we~     have found, characterized and treated at least 13 novel neurological diseases. The genetic~     basis was elucidated with geneticist colleagues both in Israel and worldwide. The diseases we~     have found encompass all the fields of pediatric neurology including intellectual disability,~     epilepsy, muscle-nerve disorders, malformations of the brain, microcephaly, macrocephaly,~     cerebellar ataxia, chorea. dystonia, cerebral palsy and many other symptoms and signs.~      We are especially interested in consanguineous families, in whom the parents are first or~     second degree cousins. These families often bear autosomal - recessive diseases. If the~     family is informative - with 2 or more affected children - then with current genetic~     techniques there is a good chance of finding the causative gene to this specific disease.~     This is not only a theoretical - academic accomplishment. In practice, after discovering the~     gene, the family is given genetic counseling and in their further pregnancies the geneticists~     will examine either by preimplantation genetic diagnosis (PGD) or amniocentesis if the embryo~     is affected or not. In the early stages of the pregnancy if the embryo is indeed affected by~     the disease caused by the gene we have found and the religious official consents, genetic~     counseling can offer termination of pregnancy to the couple.~      Needless to say, we know the immense burden of an affected child on the family, community and~     society. The parents are guilt-ridden, the affected child draws extensive resources from~     educational, health and rehabilitation authorities. We can contribute to the well-being of~     the family and the clan (because many times the relatives are affected).~      We can perform sophisticated genetic studies such as Whole Genome Sequencing and Whole Exome~     Sequencing.After an informative family is recruited to the study, we will explain the aims of~     the research. The parents and eligible patients will sign informed consent forms, according~     to the local Helsinki Board. Blood samples will be taken in Israel, DNA extracted in the~     Israeli lab and then shipped coded to the researchers in USA or Germany. If the researchers~     will find a new gene the family will be notified and given appropriate genetic counseling. We~     will continue to follow and treat the family onwards.~   "
93686|NCT02340858|"~     This trial is studying how well Irreversible Electroportion (IRE) therapy works in treating~     patients with breast cancer. IRE kills tumor cells by Electrical impulses creating nano-pore~     on the cell membrane and inducing target cell death.This may be an effective treatment for~     patients with unresectable breast cancer.~   "
93687|NCT02340845|"~     The Phase II randomized, two-armed clinical study will investigate the efficacy of high dose~     versus low dose Bromelain (Comosain) in human subjects diagnosed with advanced late stage~     cancers. The study subjects will be randomly assigned to each group by a coin toss. Bromelain~     (Comosain) extract, derived from the stem and fruit of Ananas Comosus will be administered~     orally each day.~   "
93688|NCT02340819|"~     The purpose of this study is to evaluate the safety and efficacy of an investigational~     treatment (teduglutide) in Japanese patients with PN-dependent SBS. This study will also look~     at how teduglutide moves through the body (pharmacokinetics).~   "
93689|NCT02340806|"~     Administration of anesthetic solution into the epidural space is usually accomplished by a~     combination of continuous infusion, provider-administered boluses and patient-administered~     boluses (patient controlled epidural analgesia [PCEA]). The optimal method for maintaining~     labor analgesia is unknown. Several studies have demonstrated that timed-intermittent~     boluses, in combination with patient-controlled epidural analgesia (PCEA), provide superior~     maintenance of labor analgesia than maintenance with a continuous infusion with PCEA.~     Epidural infusion pumps capable of delivering timed boluses of local anesthetic with PCEA~     recently became commercially available. Several infusion rates are available for delivering~     the timed bolus, and the optimal bolus rate is unknown.~   "
93690|NCT02340793|"~     National guidelines recommend 15-20% weight loss for severe and complicated obesity. Weight~     loss maintenance can be achieved in around 33% of patients at 12 months.~      The BEYOND study will administer Counterweight Plus; a nutritionally replete Total Diet~     Replacement Plan (TDR) of 800+ Calories followed by structured Food Reintroduction, and~     Weight Loss Maintenance programmes.~      The study will incorporate three work packages with the aim of:~        1. examining changes in body composition with substantial (target >15kg) non-surgical~          weight loss (work package 1, WP1)~        2. characterizing the metabolic adaptations during weight loss and maintenance (work~          package 2, WP2)~        3. examining Rescue Packages as a method of weight re-gain prevention (work package 3,~          WP3).~   "
93691|NCT02340780|"~     The purpose of this study is to find out what effects a new drug, buparlisib, has on chronic~     lymphocytic leukemia.~   "
93801|NCT02339350|"~     Treatment of pediatric acute lymphoblastic leukemia (ALL) has advanced and the overall~     survival exceeds 80% nowadays. However the overall survival of high risk ALL remains 75-90%,~     thus recent studies focus on treatment intensification according to the risk group. According~     to the previous reports, we designed a multicenter prospective trial for pediatric ALL.~   "
93692|NCT02340767|"~     The study will determine whether dentists who use a diagnostic device treat suspicious~     occlusal carious lesions (SOCL) surgically more often, with the same frequency, or less~     frequently, than dentists not relying on a diagnostic device. The study will also determine~     -- among those SOCLs that are opened -- whether the proportion of lesions that extend into~     the dentin when dentists are using a diagnostic device is more than, the same, or less than~     when no device is used.~   "
93693|NCT02340754|"~     The primary purpose of this study is to assess the feasibility of mindfulness-based stress~     reduction (MBSR) for adults with any type of multiple sclerosis. The secondary objectives are~     to: 1) Explore the ability of MBSR to improve perceived stress and quality of life compared~     to an education control group; and 2) Explore the durability of the effects of MBSR over one~     year.~   "
93694|NCT02340741|"~     Effect of intraoperative insufflation of carbon dioxide on the neurologic complications in~     the early postoperative period after open cardiac surgery.~   "
93695|NCT02340728|"~     The purpose of this study is to compare the effects good and/or bad of combining~     radiofrequency ablation with placement of a second stent, versus a second stent alone. The~     investigators will also look at the safety of the combination treatment, and see which~     treatment is better. In either case, the second stent will be placed inside the existing~     stent as is done in standard practice when treating a blocked stent for the first time.~   "
93696|NCT02340715|"~     The purpose of this study is to determine if it would be helpful to use advanced MRI imaging~     techniques to take additional views of the tumor target for radiation treatment planning or~     treatment follow-up MRI.~   "
93697|NCT02340702|"~     The presence of chronic obstructive pulmonary disease (COPD) would confer increased~     in-hospital mortality and length of hospital stay in patients with acute decompensated heart~     failure Assess the (1) prevalence of COPD in patients who are hospitalized for acute~     decompensated heart failure and (2) the association between COPD and in-hospital mortality or~     length of stay in this cohort.~   "
93698|NCT02340689|"~     Specific mutations relating to hyperoxaluria will be determined via DNA analysis by the Mayo~     RKSC research staff.~   "
93699|NCT02340676|"~     This research study is evaluating a combination of a therapy called Extra-corporeal~     Photopheresis (ECP) with a drug called Interleukin-2 (IL-2) as a possible treatment for~     chronic graft-versus-host-disease (GVHD) following allogeneic stem cell transplant.~   "
93700|NCT02340663|"~     Clinical trials of bite splint use and night time tooth grinding have not been performed.~     Consequently, there are no definitive outcome measures or efficacy standards that can be~     applied to large clinical trials. The present preliminary trial will determine what objective~     measures can be used to evaluate efficacy. The outcome variables will fall into four~     categories: (1) fabrication efficacy, (2) compliance, (3) functional efficacy, and (4) user~     satisfaction. The immediate goals will: (1) focus on the over-the counter SOVA night guard,~     (2) conduct tests under controlled clinical conditions using the 'gold standard', the acrylic~     'bite splint' or 'orthotic', hereafter called the Michigan bite splint, to compare the~     performance and efficacy of the SOVA night guard. Subsequent studies will be able to use the~     outcome variables identified in this study for broader clinical trials.~      Specific Aim 1. To compare the SOVA night guard to the custom-acrylic Michigan bite splint in~     clinical laboratory conditions. Hypothesis: There will be no significant differences between~     the devices in terms of fabrication efficacy, functional efficacy or user satisfaction.~      Specific Aim 2. To compare the SOVA night guard to the custom-acrylic Michigan bite splint~     under ecologically relevant conditions, i.e., the home environment. Hypothesis: There will be~     no significant differences between the devices in terms of compliance or functional efficacy.~   "
93701|NCT02340650|"~     This is a pilot study involving 100 subjects. The primary aim will be to conduct image~     analysis with the use of High resolution micro-endoscope(HRME) and Line-Scanning Confocal~     High Resolution Micro-endoscope (LSC-HRME) on the profile of normal bladder tissue, inflamed~     bladder tissue, suspicious bladder tissue and bladder cancer tissues .~      The secondary aim will be to examine the effectiveness of the new HRME and LSC-HRME device~     for early diagnosis of bladder cancer with less invasive procedure.~      This is a pilot study examining imaging analysis in patients with normal bladder tissue,~     inflamed bladder tissue, suspicious bladder tissue, and bladder cancer who are scheduled to~     have cystoscopy.~      This is a cross sectional study therefore, each patient will participate only once in this~     study. The study involves only 1 visit: Visit #1: schedules cystoscopy and biopsy procedure~     that are part of standard care and then capturing image with the use of HRME/LSC-HRME device~     as a part of research procedure.~      All the procedures performed in this study are normally done in the work-up of patients~     scheduled to have cystoscopy procedure and is considered a routine procedure for bladder~     cancer screening. The only procedure/treatment which is not routine is the use of HRME and~     LSC-HRME. Biopsy will be taken at the time of cystoscopy that involves standard of care.~     Images taken by HRME/LSC-HRME device will then be correlated with pathology results of the~     biopsied tissue. The samples will be coded and de-identified data will be sent to Dr. Rebecca~     Richards-Kortum laboratory for correlation.~      The blood and urine samples collected during the screening visit are routine tests for~     patients with bladder cancer and will be handled according to standard of practice. The test~     results will be included in the subject's research and medical charts. Additional research~     related information will be provided at the end of the study.~      Risks include those related to cystoscopy and HRME/LSC-HRME device may include infection,~     pain, difficulty with urination and blood in urine, perforation.~      Potential benefits may include to this subject class for early detection of bladder cancer~     with minimal invasive technique.~      Understanding the effects of HRME and LSC-HRME device on the bladder screening may improve~     screening and detection methodologies for future patients with bladder cancer.~   "
93702|NCT02340637|"~     The purpose of this study is to provide knowledge regarding the effect of early intervention~     and prevention on the development of anxiety and depression in children. The focus of the~     intervention is to reduce symptoms of anxiety and depression and help children develop skills~     to enhance self-esteem in order to improve life quality. Gender and ethnicity will be studied~     as moderating factors. Primary care givers will be trained in the use of evidence based~     methods for children with internalizing difficulties. Children in need will be identified and~     receive improved services, based on international standards. Active collaboration will be~     established nationally between three Centers for child and adolescent mental health~     (RKBU/RBUP) and internationally with Philip C. Kendall at the Temple University in~     Philadelphia and Kevin Stark at University of Texas at Austin.~      Primary aims are to examine if an indicated group and school based program, Coping Kids, is~     more effective than treatment as usual (TAU) in reducing high levels of symptoms of both~     anxiety and depression among 8-12 year old schoolchildren, and if the the effects are stable~     over 12 months.~   "
93724|NCT02340351|"~     The purpose of this study is to determine whether auricular acupuncture (AA) according to the~     NADA protocol and progressive muscle relaxation (PMR) differ in their effectiveness of~     treating people with anxiety disorders or major depressive disorder. We hypothesized, that~     both treatments show significant effects in alleviating the examined items (tension, anxiety,~     anger/aggression and state ofr mood) and that there is no significant difference between~     these two treatments.~   "
93703|NCT02340624|"~     Tobacco smoking in pregnancy remains one of the most important and preventable cause of~     adverse pregnancy outcomes. Data from National Survey of Drug Use and Health (NSDUH)~     suggests, that the annual average rates of current cigarette use among women aged 15 to 44~     who were not pregnant decreased from 30.7 percent in 2002-2003 to 24.0 percent in 2012-2013.~     However, the prevalence of cigarette use among pregnant women in this age range did not~     change significantly during the same time period (18.0 percent in 2002-2003 and 15.4 percent~     in 2012-2013)Smoking cigarettes during pregnancy and nursing causes considerable health~     damage to the fetus and to the infant during the initial growth phase. An estimated 19.8~     million women in the United States smoke. Nationally, 23 percent of women report smoking in~     the 3 months before pregnancy, while 13 percent report smoking in the last 3 months of~     pregnancy. Overwhelming evidence suggests that maternal smoking during pregnancy is~     associated with an adverse pregnancy outcomes including IUGR, placenta previa, abruption~     placentae, preterm premature rupture of membranes, low birth weight, perinatal mortality,~     intrapartum stillbirth and ectopic pregnancy. Moreover, prenatal exposure to tobacco smoke~     also increases risk of attention deficit and hyperactivity disorder (ADHD) and sudden infant~     death syndrome (SIDS) in the offspring.Children born to mothers who smoke during pregnancy~     are at increased risk of asthma, infantile colic, and childhood obesity.~      Brief interventions are shown to be associated with small but clear increases in smoking~     cessation in pregnancy, but are rarely used. Technology may fill this void. For the present~     study, pregnant women reporting smoking during pregnancy will be recruited and randomly~     assigned to one of eight combinations of three technology-delivered intervention approaches:~     Brief intervention, Quitline referral, and SmokeFreeMoms text messages~     (http://women.smokefree.gov/smokefreemom.aspx).~   "
93704|NCT02340611|"~     This is a phase 2 study (the second phase in testing a new drug or drug combination) to see~     how useful adding investigational drug cediranib to olaparib after disease progression on~     olaparib alone in patients with ovarian cancer.~   "
93705|NCT02340598|"~     Randomized trial of supplying a cold vest as compared with controls (no cold vest) on~     cardiovascular risk factors such as blood lipids, insulin, blood pressure and body weight and~     also on basal metabolic rate. Recruitment of 100 participants and 70 are randomized to being~     given a vest which they can use to increase basal metabolic rate during 1-2 hours (as long as~     the pre-cooled vest stays cool) by activating brown adipose tissue and/or shivering. The~     remaining 30 subjects will constitute a control group. Lab tests and anthropometrics are~     checked at baseline, after 2 months and after 1 year.~   "
93706|NCT02340585|"~     The primary objective of this study is to demonstrate effectiveness and safety of the~     Neuroform Atlas Stent System for use with bare metal embolic coils.~   "
93707|NCT02340572|"~     Anticalins® are engineered human proteins that are able to bind specific target molecules.~     The Anticalin PRS-080#022-DP to be investigated in this study is directed against hepcidin~     and is intended for treatment of anemia of chronic disease. This phase I First-in-Human study~     shall investigate safety and pharmacokinetics in healthy human volunteers.~   "
93708|NCT02340559|"~     The purpose of this study is to assess the effectiveness of Meta-Cognitive Training (EMC) in~     people with a brief psychotic disorder, especially positive symptoms.~      The secondary objectives would be to assess the effect of EMC on metacognition (cognitive~     distortions and deficits in theory of mind), psychosocial functioning and quality of life,~     neuropsychological functioning and gender, as well as determine the changes produced by EMC~     in the insight of each session and the maintenance of the effects of EMC program at six~     months of treatment.~   "
93709|NCT02340546|"~     In chronic systolic heart failure patients submitted to cardiac resynchronization therapy,~     the study aims at assessing whether geometric variations in coronary sinus lead tip~     trajectory throughout the cardiac cycle acutely induced by biventricular pacing, are~     predictive of the volumetric and clinical response to the treatment at six-month follow-up.~   "
93710|NCT02340533|"~     The purpose of this study is to develop and evaluate a hysteroscopic endo-myometrial biopsy~     for diagnosing adenomyosis.~   "
93711|NCT02340520|"~     This is a pilot study designed to evaluate the effects of theophylline and roflumilast on~     circulating Histone deacetylase (HDAC) levels in subjects with COPD, and the bronchodilator~     effects of corticosteroids. Studies will be performed in 10 subjects with COPD nonresponsive~     to bronchodilators. Subjects will receive theophylline tablets for 1 week, followed by~     measurement of circulating HDAC and the acute effect of oral prednisone on the bronchodilator~     response to inhaled beta agonist. Roflumilast tablets will be added to the theophylline for a~     further week and the studies repeated. The study will provide preliminary data on the effects~     of theophylline and roflumilast on circulating HDAC levels and the effects of corticosteroids~     on the beta agonist bronchodilator response in COPD.~   "
93712|NCT02340507|"~     This study is carried out to find out the inclusion of high and low glycaemic Index (GI)~     foods to daily meals impact on 24 hour blood glucose fluctuations and food intake.~   "
93713|NCT02340494|"~     This project proposes to develop and test an internet resource - a supported self-management~     website - that will guide younger women to relevant knowledge and resources, and provide~     tools that will help YWBC become more skilled and confident in coping with the many~     challenges of breast cancer. The study will be conducted in collaboration with the newly~     funded, pan-Canadian Young Breast Cancer Cohort (CYBCC) program being led from Women's~     College Hospital. The resource is expected to reduce knowledge gaps experienced by YWBC, and~     help them be partners in decision-making about their care, which has been shown to reduce~     anxiety and depression years later.~   "
93714|NCT02340481|"~     The purpose of this study is to evaluate the efficacy and safety of combined loperamide~     hydrochloride and simethicone compared to loperamide hydrochloride monotherapy in treating~     acute diarrhea associated with abdominal discomfort caused by gastrointestinal gas~     accumulation.~   "
93715|NCT02340468|"~     In the field of cancer treatment, it is generally accepted that the enhancement of oxygen~     delivery to tumors can augment the effect of anti-cancer therapies. In the case of~     chemotherapy, this enhancement might lead to a larger amount of a given dose of treatment~     reaching the tumor and having an effect.~   "
93716|NCT02340455|"~     Hyperalgesia is known to be caused by the excitatory amino acid through NMDA receptor. GABA,~     an inhibitory amino acid, alters the opioid receptor sensitivity against pain resulting~     hyperalgesia. If the GABA level can be maintained at certain level, the progression into~     hyperalgesia can be averted. GABA related drugs are known to decrease the postoperative~     opioid consumption, lower the degree of pain, and prevent hyperalgesia. We hypothesize the~     effective postoperative pain management and the prevention of hyperalgesia from pregabalin,~     GABA analogue, and the possible sex difference in such effects of pregabalin.~   "
94004|NCT02336698|"~     The purpose of this study is to demonstrate the efficacy, safety, and tolerability of~     fulranumab as Monotherapy compared with placebo in participants with signs and symptoms of~     osteoarthritis of the hip or knee that are not adequately controlled by current pain therapy.~   "
93717|NCT02340442|"~     Maternal obesity, overweight and hypertensive disorders are among the most important risk~     factors for complications during pregnancy. Several lines of evidence indicate that~     overweight or obese women, as well as women with hypertensive disorders show increased risks~     of preterm birth before 32 weeks. However, an easy to determine, common reliable prognostic~     factor which allows for the early identifications of risk patients is still lacking.~     Recently, it has been reported that assessment of endothelial function may be a new promising~     tool for predicting the risk of adverse pregnancy outcome. As such evidence has been provided~     that endothelial dysfunction is prevalent among women with preeclampsia and is able to~     identify women at increased risk of preterm delivery and small-for-gestational-age (SGA)~     births. Several lines of evidence indicate that functional and structural changes of retinal~     vessels are altered in vascular related disease and may predict cardio-vascular events.~     Consequently, the current study seeks to investigate whether flicker induced vasodilatation,~     a well established parameter to test vascular function in-vivo is altered in women with low~     and high risk pregnancies when compared to a healthy control group. The data gained from this~     study may provide the basis for a larger longitudinal trial to assess whether vascular~     changes in the retina may predict the risk for complication during pregnancy.~   "
93718|NCT02340429|"~     Medical care today is moving towards patient centered care (PC) and patient empowerment (PE),~     both in practice and in medical staff training . Applying this methodology enhances patient~     autonomy in the clinical setting and allows shared decision making.~      Current mobile and video technology enables the caregiver(clinician) to share visual data~     with the patient, making him or her a more active participant in the medical procedure. It~     has been shown that higher patient satisfaction rate regarding the patient/physician~     encounter, has a positive effect on medical procedure outcome and patient compliance.~      Patient centered care and Patient Empowerment benefits are maximized using the proper tools.~     One such tool is the video otoscope. In this study we apply the PC/PE approach of medical~     care and introduce video otoscopy in the setting of a pediatric emergency room. We use an~     affordable (~300$), FDA approved, High Res. video otoscope. (DE500 Digital Video~     Otoscope,Firefly global Inc.) Patients will be randomized upon admission into two groups:~     video otoscopy and standard otoscopy. Upon discharge from the pediatric ER, parents will be~     asked to answer a short questionnaire regarding their satisfaction with the ER visit and the~     otoscopic examination.~      We aim to study the impact of affordable, high res. video otoscopy, on the general~     satisfaction of parents from their emergency room experience, vs their experience when~     undergoing a regular otoscopic examination.~      Inclusion criteria: children under 18y admitted to the pediatric ER for any reason,~     undergoing routine otoscopy, who's parents have signed an informed consent.~      Exclusion criteria: no parental informed consent,lake of compliance or inability to perform~     otoscopy.~      Number of participants: 60 (30 in each group) Study start: January 2015 Study ends:January~     2016 Study location: Ziv medical center, Zefat Israel~   "
93719|NCT02340416|"~     Cerebral microemboli (ME) are frequently generated during major orthopaedic surgery. The~     primary objective of this study was applying novel transcranial Doppler (TCD) ultrasound~     software algorithm to quantify (ME load/15 minutes) and qualify (particulate vs. gaseous) ME,~     detected as high-intensity transient signals (HITS) in both middle cerebral arteries (MCAs)~     before and after orthopaedic surgery.~   "
93720|NCT02340403|"~     Neurotoxic chemotherapy, including oxaliplatin, are responsible for very disabling~     neuropathic pain that can last for months or even years after the end of chemotherapy.~     Currently, there is no effective neuroprotective treatment to prevent or relieve this pain.~     The only strategy is the reduction of oxaliplatin doses or premature discontinuation of~     therapy, with the risk of burdening the prognosis for remission. Thus, a better understanding~     of the pathophysiology of these iatrogenic neuropathies appears necessary in order to~     discover new potential therapeutic targets.~      Preclinical works were able to demonstrate important metabolic changes in certain brain~     structures in an animal model of oxaliplatin-induced neuropathy. A significant increase of~     choline concentration has been found in the posterior insular cortex of neuropathic animals~     compared with control animals. Furthermore, the concentrations of choline were positively~     correlated to nociceptive thresholds. Thus, neuropathic pain induced by oxaliplatin would~     involve the posterior insular cortex and would be associated with an increase in choline~     concentration at this level. Clinical translation of these preclinical results is feasible in~     practice since choline concentration can be determined in the brain by non-invasive magnetic~     resonance spectroscopy.~   "
93721|NCT02340390|"~     Evaluate the safety and effectiveness of patients who received G7 Acetabular system in~     conjunction with Ceramic on Ceramic articulation and Taperloc Complete Microplasty stem~     compared to patients who received the Exceed ABT Acetabular system with the same combination~   "
93722|NCT02340377|"~     The primary objective of the proposed study is to determine the use of a wireless method to~     monitor and record core body temperature during a Whole Body Hyperthermia treatment, compared~     to an indwelling rectal thermometer.~      This protocol is intended to study the differences between a rectal temperature probe and an~     approved wireless and indigestible thermometer during a WBH session. The current standard in~     monitoring core body temperature is the usage of an indwelling rectal thermometer. Many~     patients and potential study subjects, however, decline receiving the treatment, due to the~     discomfort of using this measuring method and a wireless measuring device would open the~     possibility for those patients to receive a treatment. The primary endpoint for example of a~     treatment for MDD is currently defined with reaching a rectal temperature of 38.5 C. However,~     due to the proximity of the probe to the body's surface, the core body temperature will vary~     from the rectal temperature and the comparison between the two methods with a validation of~     the wireless device is necessary.~      The investigators will monitor subject's physiological outcome from a single Whole Body~     Hyperthermia treatment in an open fashion (no placebo/control condition). This study will~     include safety assessments 7 days several days prior to or same day as the WBH, and include~     follow-up assessments 1 day and 1 week later.~   "
93723|NCT02340364|"~     The investigators are asking subjects to take part in the Patient NAVIgation to Reduce~     Readmissions among Black Men with Heart Disease (NAVI-HF) research study. This research study~     will test how well trained laypeople working as patient navigators will help patients~     recently hospitalized for heart failure avoid future hospitalizations. NAVI-HF is a new~     program sponsored by funding from the National Institute of Minority Health and Health~     Disparities. People who enter into the study will work with a patient navigator to undergo~     the full program or work with a trained layperson to receive general education on heart~     disease treatment and prevention. The purpose of the study is to determine whether a patient~     navigation program will be effective in reducing the number of hospitalizations in the future~     for program participants. This study will enroll 416 participants from UAB.~   "
98811|NCT02273882|"~     Purpose of this study is to evaluate clinical, humanistic and health economic burden of~     Respiratory Syncytial Virus (RSV) in infants born 29 to 35 Weeks Gestational Age (wGA)~     hospitalized for RSV at up to 12 months of age.~   "
93725|NCT02340338|"~     Toxic Shock Syndrome (TSS) a severe condition with high morbidity and mortality results from~     the hosts overwhelming inflammatory response and cytokine storm. Staphylococcal superantigen~     toxins are the main causative agents. Toxic shock syndrome toxin (TSST-1) being responsible~     for almost all of menstruation associated and more than 50% of all other cases. There is no~     specific therapy.~      The aim of this study is to demonstrate the safety and tolerability of the BioMed recombinant~     toxic shock syndrome toxin (rTSST-1) Variant Vaccine in healthy adults. The second aim of the~     study is to measure antibodies in the blood of these healthy volunteers which have been~     produced in response to treatment with the BioMed rTSST-1 Variant Vaccine. These antibodies~     are expected to be important in resistance against the diseases. 46 healthy adults, male and~     female, age 18-64 years will be assigned to 6 dose groups of the vaccine at the Department of~     Clinical Pharmacology of the Medical University of Vienna. The patients will be monitored for~     vital signs, hematology, clinical chemistry, blood cytokine level and antibodies against~     TSST-1. Immunization will be repeated 4 weeks after the first with the same dose.~   "
93726|NCT02340325|"~     Background Scarring typically occurs after trauma, burn injury or surgery. Hypertrophic~     scarring presents as raised, red and itchy lesions which variably respond to various~     treatment modalities, such as corticosteroids, pressure garments, laser therapy, the use of~     silicone sheets and radiotherapy.~      Kynurenine, or Fibrostop 1 (FS1), and its further breakdown products, such as kynurenic~     acid, or Fibrostop 2 (FS2), are endogenous products found in many systems and have shown~     potential in reducing scar formation in animal studies.~      The aim of study is to evaluate the safety and tolerability of FS2 cream applied to the skin~     of healthy human subjects.~   "
93727|NCT02340312|"~     Recurrent abdominal pain has long been acknowledged to be the most common chronic pain~     entities in children. The purpose of this study is to describe the microbiome in children~     with FD and to explore relationships between the microbiome and postprandial distress~     syndrome, anxiety scores, and mucosal biomarkers or anxiety. The specific goals of this study~     are to: 1) Determine the frequencies and relative proportions for specific bacteria or~     bacteria phyla in children with FD in both duodenal mucosal specimens and stool samples. 2)~     Determine if the frequencies or proportions of specific bacteria or bacteria phyla differ~     between children with and without PDS. 3) Determine bi-variate correlations between~     bacteria/phyla frequency, bacteria/phyla proportions, anxiety scores, and mucosal biomarkers,~     respectively.~   "
93728|NCT02340299|"~     To investigate whether nasal high frequency oscillation ventilation (nHFOV) immediately after~     extubation reduces the arterial partial pressure of carbon dioxide (paCO2) at 72 hours after~     extubation in comparison with nasal continuous positive airway pressure (nCPAP) in very low~     birth weight infants (VLBWs).~   "
93729|NCT02340286|"~     The purpose of this study is to determine energy expenditure and fat oxidation in 2 year old~     children.~   "
93730|NCT02340273|"~     Human clinical trial to measure the effect of long duration therapeutic ultrasound on tendon~     injuries. The hypothesis is that use of long duration ultrasound will relieve pain, increase~     tendon strength, and improve quality of life for patients with tendon injury.~   "
93731|NCT02340260|"~     Exercise is considered a cornerstone in the prevention and treatment of type 2 diabetes, but~     few patients exercise according to guidelines. In this study the effect of two time efficient~     high intensity exercise protocols on glycemic control and other cardiometabolic risk factors~     are investigated in patients with type 2 diabetes.The investigators assume that glycemic~     control is improved more by low-volume high intensity interval training than by extremely~     low-volume sprint interval training.~   "
93732|NCT02340247|"~     The purpose of this study is to examine the effects of bile acids on GLP-1 secretion after~     Roux-en-Y gastric bypass.~   "
93733|NCT02340234|"~     This randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy~     of lebrikizumab administered subcutaneously (SC) in adult participants with persistent~     moderate to severe atopic dermatitis (AD) who are inadequately controlled by topical~     corticosteroids (TCS). The study includes a screening visit, a 2-week run-in period, a~     12-week blinded treatment period, and an 8-week safety follow-up period. Following screening~     visit, eligible participants will enter in run-in period (Days − 14 to − 1) during which a~     protocol-specified topical therapy regimen will be initiated. At the end of the run-in~     period, participants who have: 1) demonstrated compliance with the protocol-specified TCS~     regimen, and 2) who continue to fulfill the eligibility criteria will be randomized.~   "
93734|NCT02340221|"~     This international, multicenter, randomized, double-blinded, placebo-controlled study is~     designed to compare the efficacy and safety of taselisib + fulvestrant with that of placebo +~     fulvestrant in postmenopausal women with estrogen receptor (ER)-positive, human epidermal~     growth factor receptor-2 (HER2)-negative, oncogene that encodes for~     phosphatidylinositol-4,5-bisphosphate 3-kinase (PIK3CA)-mutant, unresectable, locally~     advanced or metastatic breast cancer after recurrence or progression during or after an~     aromatase inhibitor (AI) therapy. There will be a 2:1 randomization to the taselisib arm~     versus the placebo arm. Enrollment will be enriched for participants with PIK3CA mutant~     tumors via central testing. The anticipated duration of the study is approximately 3.5 years.~   "
93735|NCT02340208|"~     The primary purpose of this research study is to evaluate how safe, how well tolerated and~     how effective a range of doses of L-DOS47 in patients with non-squamous non-small cell lung~     cancer when given as a monotherapy.~   "
93736|NCT02340195|"~     The purpose of this study is to evaluate the pharmacokinetics properties of idalopirdine~     following multiple dosing in patients with renal impairment and compare to those in healthy~     subjects~   "
93737|NCT02340182|"~     The objective of this study is to investigate the role of the gut microbiota in the systemic~     priming of immune effector cells. Twelve healthy male volunteers, 18-35 years of age, will be~     treated with broad spectrum antibiotics (ciprofloxacin, vancomycin, metronidazole) for seven~     days, in order to deplete the gut microbiota. Blood and faeces will be sampled before, 24~     hours and 6 weeks after the 7-day period of antibiotics. Main study endpoints include~     laboratory parameters for inflammatory responses, functional assays (ex vivo stimulation~     assay) and gut microbiota composition.~   "
93738|NCT02340169|"~     The objective of this study is to evaluate the potential of Topicort® (desoximetasone)~     Topical Spray, 0.25% to suppress hypothalmic pituitary adrenal axis function. The secondary~     objectives are to evaluate the efficacy parameters, pharmacokinetics and adverse event~     profile.~   "
93739|NCT02340156|"~     This Phase II clinical trial is an open label, single arm, multicenter study of the~     combination of intravenously administered SGT-53 and oral temozolomide in patients with~     confirmed glioblastoma who have proven tumor recurrence or progression. The objective of this~     trial is to assess 6 month progression free survival (PFS), overall survival (OS), anti-tumor~     activity, safety and possibly to evaluate, nanoparticle delivery to tumor site, and the~     induction of apoptosis in the tumor..~   "
93740|NCT02340143|"~     The study is intended to assess the amount of crying and fussiness in infants fed an infant~     formula containing probiotics.~   "
93741|NCT02340130|"~     This is an open-label, non-controlled, non-randomised, prospective safety study in patients~     with rhinitis or allergic rhinoconjunctivitis, with controlled asthma, and clinically~     relevant sensitisation to dust mites from the Pyroglyphidae and Glycyphagidae families.~   "
93742|NCT02340117|"~     This clinical trial is an open label Phase II study of the combination of intravenously~     administered SGT-53 and gemcitabine/nab-paclitaxel in patients with metastatic pancreatic~     cancer as a first-line treatment. The objective of the study is to evaluate the safety,~     tolerability, toxicity and efficacy (specifically Progression Free Survival at 5.5 month~     (PFS5.5mos)) of this combination therapy.~   "
93743|NCT02340104|"~     The purpose of this study is to compare how much baricitinib (study drug) gets into the blood~     stream when it is given as a single dose (in tablet form) and as an intravenous infusion~     (injection given directly into a vein via a small needle). Each participant in the study will~     make four visits to the investigator site over the course of about 6 weeks.~   "
93744|NCT02340091|"~     The objective of this study was to evaluate the efficacy and safety of HA IDF plus (with~     lidocaine) injected in the nasolabial fold compared to HA IDF (without lidocaine).~   "
93745|NCT02340078|"~     The objective of this study was to evaluate the efficacy and safety of HA IDF II plus (with~     lidocaine) injected in the nasolabial fold compared to HA IDF II (without lidocaine).~   "
93746|NCT02340065|"~     The aim of this study is to evaluate Endocuff- assisted colonoscopy in terms of its possible~     additive contribution in the detection of important lesions, namely polyps and cancers,~     compared to standard colonoscopy, in a series of patients undergoing back-to-back screening~     or surveillance colonoscopies in a randomized fashion. Moreover, we aim to assess possible~     changes regarding post-polypectomy surveillance programs following Endocuff utilization.~   "
93747|NCT02340052|"~     This is a prospective observational cohorte study. The aim is to investigate actual pain~     treatment and outcomes in a large population of total hip arthroplasty patients at 5~     different hospitals in Denmark.~   "
93748|NCT02340039|"~     Raised blood glucose levels can lead to adverse modifications to functional proteins within~     the body and eventually lead to the development of type 2 diabetes. Fruit polyphenols may~     help to control glycaemia following a carbohydrate meal or beverage. The aim of this study is~     to investigate the effects of blackcurrant (BC) and apple (A) extracts on postprandial~     glycaemia, insulinaemia and plasma gastric inhibitory polypeptide concentrations following a~     mixed carbohydrate test meal.~   "
93749|NCT02340026|"~     The purpose of this study is to determine the optimal treatment duration of a novel early~     mobility training program (dynamic supported mobility, DSM) between 6 to 24 weeks of~     treatment; and to evaluate the clinical futility of this intervention compared to current~     rehabilitation practice.~   "
93750|NCT02340013|"~     This is a pilot study examining the feasibility of implementing a large randomized control~     trial looking at the effect of endometrial shedding with medroxyprogesterone acetate compared~     to no pre-treatment in women taking clomiphene citrate for ovulation induction for~     infertility due to oligo-ovulation or anovulation.~   "
93751|NCT02340000|"~     The aim is to determine if high-dose amoxicillin/clavulanate is more effective than~     standard-dose amoxicillin/clavulanate in treating acute bacterial sinusitis in adults seen at~     a primary care office.~   "
93752|NCT02339987|"~     Procure Tumor and Initiate Melanoma Tumor-Reactive Tumor Infiltration Lymphocytes (TIL)~   "
93753|NCT02339974|"~     The goal of this study is to determine the short term safety (<30 days) and efficacy (6~     months) of the heterotopic implantation of the Edwards-Sapien XT valve in the inferior vena~     cava for the treatment of severe tricuspid regurgitation in patients who are inoperable or at~     a very high surgical risk for tricuspid valve replacement.~   "
93754|NCT02339961|"~     Doppler signals can be recorded from the lung parenchyma by means of a pulsed Doppler~     ultrasound system incorporating a special signal processing package- the Transthoracic~     Parametric Doppler (TPD) (Echosense Ltd., Haifa, Israel). Systemic sclerosis patients often~     develop pulmonary vascular disease leading to pulmonary hypertension. The TPD system may~     provide important insight into pulmonary blood vessels characteristics by the LDS (Lung~     Doppler Signals) signals that are related to pulmonary hypertension. The TPD performance in~     detecting PAH in SSc patients will be assessed in the study.~   "
93755|NCT02339948|"~     Patients with locally confined prostate adenocarcinoma (clinical stage T1c - T2bN0M0, Gleason~     score 7, PSA 20 ng/ml) are assigned to one of two treatment arms. Low risk patients (T1c-T2a~     and PSA <10 ng/ml and Gleason Score 6 or less) will receive 5 fractions of 8.0 Gy for a total~     of 40 Gy. Intermediate risk patients (T2b or PSA >10 ng/ml orGleason Score 7) will receive~     1.8 Gy of IMRT for 25 fractions over 5 weeks for a total of 45 Gy. They will then receive a~     boost consisting of 4, 5.5 Gy fractions after IMRT for a total of 22 Gy.~   "
93756|NCT02339935|"~     This study aims to implement and test a specific brief Applied Behavior Analysis model for~     assessing and responding to severe challenging behavior during acute medical and behavioral~     hospitalization for children with ASD. The investigators will evaluate the impact of this~     program by conducting a randomized trial across both medical and psychiatric hospital~     settings.~   "
93757|NCT02339922|"~     This phase II trial studies how well ixazomib citrate and rituximab work in treating patients~     with B-cell non-Hodgkin lymphoma that grows slowly (indolent). Ixazomib citrate may stop the~     growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal~     antibodies, such as rituximab, may block cancer growth in different ways by targeting certain~     cells. Giving ixazomib citrate together with rituximab may work better in treating indolent~     B-cell non-Hodgkin lymphoma.~   "
93758|NCT02339909|"~     This trial is a randomised controlled trial to assess whether annual attendance rates at~     diabetic eye screening appointments in Kensington, Chelsea and Westminster could be improved~     by offering invitees a small financial incentive. The research questions are:~        1. Are incentives an effective strategy to encourage participation in the screening~          programme?~        2. Does the design of the financial incentive scheme affect its effectiveness in~          influencing participation in health screening?~        3. Does the choice of incentive scheme, if successful, attract patients who have a~          different demographic or socioeconomic status to those who attend screening regularly?~        4. Is offering these incentives a cost-effective strategy for enhancing participation?~   "
93759|NCT02339896|"~     To determine Immunogenicity and Safety Study of Modified TRC-ID Regimen with A New~     Chromatographically Purified Vero Cell Rabies Vaccine (SPEEDA®) as post exposure rabies~     intradermal regimen with or without Rabies Immunoglobulin in Children~   "
93760|NCT02339883|"~     Background:~      - Magnetic resonance imaging (MRI) creates high-quality images of the human body without~     x-rays. It uses a strong magnetic field and radio waves to take pictures. Researchers want to~     test a scanner that uses a high magnetic field strength.~      Objective:~      - To study how the body responds to being in a high field 11.7T MRI scanner.~      Eligibility:~      - Healthy people ages 22 65.~      Design:~        -  Participants will be screened with a medical history and physical exam. They will~          complete a healthy volunteer questionnaire and an MRI safety screening form. They may~          have a 3T MRI scan of the brain.~        -  Participants will have an MRI scan. They will lie on a table that will slide in and out~          of the MRI cylinder very slowly. They will be asked to lie still.~        -  Participants will do simple tasks while inside the machine. These can include listening~          and responding to questions, tapping fingers, or moving a hand.~        -  While in the scanner, participants will hear loud knocking noises. They will get~          earmuffs.~        -  Right when they exit the scanner, participants will get a questionnaire to fill out.~          This will ask about how they felt inside the scanner.~        -  During the MRI, participants heart rate, respiratory rate, and skin temperature will be~          measured. Before and after the scan, these things plus blood pressure will be measured.~        -  Participants will be tested before and after being in the MRI scanner. They will answer~          questions, take pen-and-paper or computer tests, and do simple actions. Their sense of~          smell may be tested.~   "
93761|NCT02339870|"~     This randomized clinical trial studies expressive writing in improving the wellbeing or~     comforting capacity of caregivers of patients with cancer. Expressive writing is a type of~     intervention that asks people to write about important topics (in this case participants'~     experience with their spouses'/partners' cancer) and their emotions/feelings surrounding~     them. Expressive writing, including benefit finding and traumatic disclosure, may be a type~     of at-home-therapy that caregivers can utilize in an attempt to increase their own wellbeing,~     offer better comfort to cancer patients, and by association, help cancer patients cope with~     and manage the cancer experience.~   "
93762|NCT02339857|"~     The purpose of this study was to investigate whether the no-touch saphenous vein grafts that~     were used in coronary artery bypass surgery between 2003-2008 had a patency rate comparable~     to the left internal thoracic artery when the vein grafts were anatomised to the left~     anterior descending artery.~   "
93763|NCT02339844|"~     The study is a prospective 2 year multimodal follow-up study of initially antipsychotic-naïve~     first-episode psychotic patients involving a standardized intervention with monotherapy with~     aripiprazole during the first 6 weeks. Patients and matched healthy controls will be examined~     after 6 weeks, 6 months and 2 years. They will be examined with MR-scannings, neurocognitive~     tests, EEG, and PET-scannings.~   "
93764|NCT02339831|"~     The purpose of this study is to determine how well an active motion device, Camoped, works~     compared to a continuous passive motion device, CPM, for rehabilitation after partial or~     total knee replacement. It is hypothesized that the Camoped active motion device will provide~     outcomes equal to or superior than the CPM. Patients undergoing either partial or total knee~     replacement will be given the opportunity to participate. If they elect to participate,~     preoperative data will be collected including demographics, measures of strength, balance and~     knee bending, as well as surveys regarding current physical and mental health, as well as~     knee function. After surgery, patients will be randomly selected to receive either the~     Camoped or the CPM for use during their rehabilitation. After discharge, participants will be~     asked to maintain a daily diary tracking their use of the assigned device, as well as their~     daily pain levels. At a visit 4 weeks after surgery, participants will be asked to complete a~     series of surveys pertaining to their health and knee function, as well as to perform tests~     of strength, balance and knee bending. These results will be used to determine if one device~     produces superior rehabilitation results following total or partial knee replacement surgery.~   "
93765|NCT02339818|"~     The main purpose is to evaluate the effectiveness of the Eliquis® (apixaban) Prescriber Guide~     and Patient Alert Card in terms knowledge of the important identified risk of bleeding~     associated with Eliquis treatment communicated by the RM tools.~   "
93766|NCT02339805|"~     This is a prospective descriptive monocentric study whose purpose is to describe the clonal~     evolution of the mutational pattern in cfDNA of a cohort of patients with Diffuse Large~     B-Cell Non-Hodgkin Lymphomas (DLBCL) before, during and after standard treatment~   "
93767|NCT02339792|"~     This randomized controlled pragmatic study is aimed to set-up, assess and implement an~     integrated e-learning program of medical education in an hospital setting, focused on~     teaching and implementing CGA added to geriatric pharmacological notions (GPNs) to improve~     the quality of drug prescribing in elderly patients~   "
93768|NCT02339779|"~     This multicentre randomized controlled trial aims to evaluate a new breast reconstruction~     technique- autologous fat transfer (AFT). Female patients with breast cancer schedule to~     receive a mastectomy (or having undergone mastectomy in the past) will be randomized to~     undergo breast reconstruction with either AFT (intervention group) or reconstruction with~     implants (control group). AFT will be evaluated in terms of quality of life, aesthetic~     result, complications, oncological safety and cost-effectiveness.~   "
93788|NCT02339519|"~     This study aimed to compare the advantages and disadvantages of LMA Supreme, LMA Classic and~     LMA Fastrach regarding ease of insertion, repositioning, insertion time, effects on~     hemodynamic parameters, provision of adequate and safe airway, and oropharyngeal and systemic~     complications.~   "
93769|NCT02339766|"~     Most women having planned cesarean section receive spinal anesthetic for the procedure.~      Typically, spinal opioids are administered during the same time as a component of multimodal~     analgesia to provide pain relief in the 16-24 hr period postoperatively. However, spinal~     opioids are frequently associated with adverse effects such as nausea, pruritus, sedation and~     occasionally respiratory depression.~      The quadratus lumborum (QL) block is a regional analgesic technique which blocks T5-L1 nerve~     branches and has an evolving role in postoperative analgesia for lower abdominal surgeries~     and is a potential alternative to spinal opioids. There is some evidence that it may provide~     visceral along with somatic pain relief. It is a simple and safe technique that has been~     studied in lower abdominal surgeries, but has not been studied for pain relief after cesarean~     section.~      If found effective, it will have the advantage of a reduction in opioid associated adverse~     effects while providing similar quality of analgesia. This block has evolved from the~     previously known transversus abdominis plane block.~      We propose to undertake a study that will compare the relative efficacy of QL block with~     local anesthetic to spinal morphine. We will also study if it provides any incremental~     benefit when administered in addition to spinal morphine.~   "
93770|NCT02339753|"~     Carboplatin is widely used for conditioning regimens of autologous hematopoietic stem cell~     transplantation for pediatric solid tumor, but the pharmacokinetics has not been evaluated in~     pediatric stem cell transplantation before. As carboplatin have renal toxicity, the~     pharmacokinetic study of carboplatin would help the safe and effective administration of~     carboplatin for transplantation patients. Especially, the dose of carboplatin is higher at~     conditioning chemotherapy, resulting in higher toxicity.~      Carboplatin is a drug mostly excreted by kidney, and the dose of carboplatin is recommended~     according to the body surface area and kidney function, represented by glomerular filtration~     rate. After analyzing the pharmacokinetics of carboplatin, analyses will also be done for the~     methods to determine the appropriate carboplatin dose.~   "
93771|NCT02339740|"~     This phase III trial studies tretinoin and arsenic trioxide in treating patients with newly~     diagnosed acute promyelocytic leukemia. Standard treatment for acute promyelocytic leukemia~     involves high doses of a common class of chemotherapy drugs called anthracyclines, which are~     known to cause long-term side effects, especially to the heart. Tretinoin may stop the growth~     of cancer cells by blocking some of the enzymes needed for cell growth. Arsenic trioxide may~     stop the growth of cancer cells by either killing the cells, by stopping them from dividing,~     or by stopping them from spreading. Completely removing or reducing the amount of~     anthracycline chemotherapy and giving tretinoin together with arsenic trioxide may be an~     effective treatment for acute promyelocytic leukemia and may reduce some of the long-term~     side effects.~   "
93772|NCT02339727|"~     It's known that Docosahexaenoic acid DHA and all Polyunsaturated Fatty Acids PUFA are~     important in neurodevelopment of term and preterm infants. This study tried to determine the~     utility of a balanced contribution of DHA and Arachidonic acid AA (omega-6/omega-3) in milk~     formula, with a ratio similar to that found in breastfeeding, equal to 2, in very premature~     infants less than 1500 grams and / or less than 32 weeks of gestational age. To evaluate~     values of fatty acids they have in blood and psychomotor development they achieve.~   "
93773|NCT02339714|"~     A multi-centre clinical trial done by us（ISRCEN90807007）showed that active acupuncture had~     significantly greater effect on symptoms of allergic rhinitis than either sham acupuncture or~     no active treatment. The object of that study was to evaluate the effectiveness and safety of~     acupuncture for allergic rhinitis. As an explanatory research, acupuncture was defined as the~     only intervention for treatment group and sham acupuncture, no active treatment as its~     control groups. Besides, acupuncture combined moxibustion showed better and longer effect~     than acupuncture on allergic rhinitis patients in our previous pilot study. According to this~     result, we are taking a pragmatic randomized controlled trial to further evaluate whether~     acupuncture combined moxibustion is more effective than conventional treatment.~   "
93774|NCT02339701|"~     The primary goal of this phase II study is to compare the change of EPIC HRQOL scores (1-year~     minus baseline) between SBRT and IMRT.~   "
93775|NCT02339688|"~     Current study will investigate the quality (psychometric properties) and clinical utility of~     several mobility measures, according to disability level. Therefore, several aspects will be~     inquired:~        -  Was there an effect of rehabilitation~        -  Is the measure able to detect change over time? And thus the change exceed measurement~          error and is it clinically important (responsiveness)~        -  Does the measure assess what it claims to measure (validity)~        -  Is the measure able to differentiate all performances of the patients, inclusively the~          very good and very bad performances (floor and ceiling effects)~        -  Does the measure gives similar results under consistent test conditions on another~          testing day (reliability) Worldwide, theoretical approaches to physical therapy and~          rehabilitation in Multiple Sclerosis often appear significantly different. Since the~          present research protocol will be performed at different centers across European~          countries (and US sites), this multi-center study can additionally be applied for~          mapping the volume and content of rehabilitation, as well as the differential impact of~          diverse rehabilitation approaches and training volume on mobility, for several~          disability levels.~      Some health-economic analyses will be performed to examine what the approximate cost of~     rehabilitation compared to effects is and what drivers of costs are (setting, equipment,~     staff).~   "
93789|NCT02339506|"~     Models of stress such as hypoglycemia have identified that stress results the next day in~     decreased baroreflex sensitivity. This project will test the hypothesis that these delayed~     changes in autonomic nervous system function are secondary to a rise in ACTH. The~     investigators will infuse cosyntropin versus placebo in a double-blind, crossover study in~     healthy adults and measure the delayed effects on the autonomic system as measured by~     cardiovagal baroreflex sensitivity.~   "
93800|NCT02339363|"~     The present study was a randomized controlled trial that explored the feasibility,~     acceptability, and effectiveness of short-term mindfulness training among adolescents. The~     primary purpose was to investigate the effectiveness of two main Mindfulness-Based Stress~     Reduction components—sitting meditation and hatha yoga—on working memory, stress, anxiety and~     mindfulness. The influence of daily home practice compliance on intervention outcomes was~     also examined.~   "
93776|NCT02339675|"~     Current study will investigate de quality (psychometric properties) and clinical utility of~     several measures of upper limb function, according to disability level. Therefore, several~     aspects will be inquired:~        -  Was there an effect of rehabilitation~        -  Is the measure able to detect change over time? And thus the change exceed measurement~          error and is it clinically important (responsiveness)~        -  Does the measure assess what it claims to measure (validity)~        -  Is the measure able to differentiate all performances of the patients, inclusively the~          very good and very bad performances (floor and ceiling effects)~        -  Does the measure gives similar results under consistent test conditions on another~          testing day (reliability) Worldwide, theoretical approaches to physical therapy and~          rehabilitation in Multiple Sclerosis often appear significantly different. Since the~          present research protocol will be performed at different centers across European~          countries (and US sites), this multi-center study can additionally be applied for~          mapping the volume and content of rehabilitation, as well as the differential impact of~          diverse rehabilitation approaches and training volume on mobility, for several~          disability levels.~      Some health-economic analyses will be performed to examine what the approximate cost of~     rehabilitation compared to effects is and what drivers of costs are (setting, equipment,~     staff).~   "
93777|NCT02339662|"~     The purpose of the study is comparing two drugs efficacy for the treatment of pain originates~     from masticatory muscles. The two drugs are - Amitriptlyne (amitriptyline) and Gabapentin~     (gabapentin), both of them are common use in for the treatment of chronic pain Methods -~     patient that is diagnosed as suffering from myofacial pain, will receive one of the~     medications above (Gabapentin or amitriptyline) for one month only, after which he will be~     invited to pain clinic for control. Two weeks after that, the patient will start taking the~     other drug for 1 month and then invited again to the department for recall and continue~     standard treatment . The patient can choose whether to continue medication with one of the~     drugs or stop this medication treatment. Total duration of the experiment is two and a half~     months.~   "
93778|NCT02339649|"~     The main goals of this study are to provide a cognitive, neurological, brain morphological,~     and serological profile of sepsis survivors in order to make long-term prognosis of recovery~     and estimate the need for rehabilitation measures in order to help patients reintegrate into~     normal daily life.~   "
93779|NCT02339636|"~     A clinical study of subclinical enthesitis and synovitis in patients with vulgaris psoriasis~   "
93780|NCT02339623|"~     If we could prove that three -dimensional ultrasound measurement of fetal adrenal gland~     volume can accurately predict the likelihood of preterm birth in patients having symptoms and~     signs of PTL , we would be able to use it as a valuable component for assessment and early~     management of high risk pregnant women for PTB which can be positively reflected on the risk~     of neonatal morbidity and mortality in those patients.~   "
93781|NCT02339610|"~     This post-marketing investigation will evaluate the rate of recovery of the ATTUNE knee from~     the time of surgery through the 6 month endpoint in patients with severely painful and/or~     severely disabling Non-inflammatory Degenerative Joint Disease (NIDJD).~   "
93782|NCT02339597|"~     Primary hypothesis:~      The objective compliance ( # of hours per night of APAP therapy) is higher in patients who~     get the APAP treatment initiation at home due to the fact that they get better support by~     telemetric control and the possibility of prompt interventions.~      Secondary hypothesis:~      Based on the higher support at the home APAP initiation the following parameters will be~     better in comparison to the standard supply in laboratory:~      Objective measures:~        -  mask leakage~        -  pressure~        -  Apnea-Hypopnea-Index (AHI)~      Subjective measures:~        -  quality of life~        -  sleepiness~   "
93783|NCT02339584|"~     The purpose of this study is to compare the fixed combination (BID) [Brinzolamide 10 mg/mL /~     Brimonidine 2 mg/mL eyes drops, suspension] to the unfixed combination (BID) [Brinzolamide 10~     mg/mL eye drops, suspension plus Brimonidine 2 mg/mL eyes drops, solution] with respect to~     intraocular pressure (IOP)-lowering efficacy.~   "
93784|NCT02339571|"~     This randomized phase II/III trial studies the side effects and best dose of nivolumab and~     ipilimumab when given together with or without sargramostim and to see how well they work in~     treating patients with stage III-IV melanoma that cannot be removed by surgery. Monoclonal~     antibodies, such as ipilimumab and nivolumab, may kill tumor cells by blocking blood flow to~     the tumor, by stimulating white blood cells to kill the tumor cells, or by attacking specific~     tumor cells and stop them from growing or kill them. Colony-stimulating factors, such as~     sargramostim, may increase the production of white blood cells. It is not yet known whether~     nivolumab and ipilimumab are more effective with or without sargramostim in treating patients~     with melanoma.~   "
93785|NCT02339558|"~     This phase II trial studies how well nivolumab works in treating patients with nasopharyngeal~     cancer that has returned after a period of improvement (recurrent) and/or has spread to other~     parts of the body (metastatic). Monoclonal antibodies, such as nivolumab, may block tumor~     growth in different ways by targeting certain cells.~   "
93786|NCT02339545|"~     This is an acute, observational, prospective, multi-center clinical study to evaluate~     Coronary Flow Reserve using the Volcano FloWire® after treatment with Orbital Atherectomy and~     stenting of de-novo severely calcified lesions due to Coronary Artery Disease. 15 subjects~     will be enrolled in up to 3 active U.S. study sites. Subjects who undergo successful~     revascularization using Orbital Atherectomy and stenting will be eligible for enrollment. All~     enrolled subjects will be treated with the OAS and stenting and seen at 24 hours or at~     discharge, whichever is earlier. The purpose of the study is to evaluate coronary artery flow~     reserve following successful treatment of severely calcified coronary lesions with the OAS~     and stenting.~   "
93787|NCT02339532|"~     The main objective of this multicenter study will therefore be to evaluate pathologic~     complete response rates of an anthracycline-based regimen [FEC 100 - TAXOTERE® - HERCEPTIN® -~     PERTUZUMAB] and a non anthracycline-based regimen [TAXOTERE® - CARBOPLATINE - HERCEPTIN® -~     PERTUZUMAB] according to the presence or not of TOP2A gene amplification in a population of~     breast cancer patients with HER2 overexpression.~      A very important objective of the study will be the evaluation of biomarkers that predict~     response to treatment.~   "
98918|NCT02272491|"~     The aim of the present study is to test whether or not the use of translucent monolithic~     zirconia crowns bonded to a titanium base abutment perform similar to~     porcelain-fused-to-metal crowns on single implants in the posterior region.~   "
93790|NCT02339493|"~     Atrial fibrillation (AF) is the most preventable cause of stroke. CHADS and CHA2DS2VASc~     scores predict the likelihood of stroke in patients with nonvalvular AF. Atrial flutter~     confers a similar risk of stroke as atrial fibrillation. Anticoagulant therapy with warfarin,~     dabigatran, rivaroxaban, apixaban, and edoxaban is effective for prevention of thromboembolic~     stroke in most patients with AF. However, despite widely available risk stratification tools,~     five options for anticoagulation, and evidence-based practice guidelines, thromboprophylaxis~     for stroke prevention in AF is under-prescribed in the U.S., Europe, and worldwide. The~     investigators have previously demonstrated the efficacy of an alert-based computerized~     decision support (CDS) strategy for prevention of symptomatic venous thromboembolism (VTE) in~     at-risk hospitalized patients not receiving any thromboprophylaxis. The investigators' goal~     is to create and evaluate an alert-based CDS strategy for stroke prevention in patients with~     nonvalvular AF or atrial flutter in a randomized controlled trial.~   "
93791|NCT02339480|"~     This project is to penetrate and consummate the research mechanism of massage therapy on~     simple obesity. Latest researches indicate that the energy regulation network system of~     hypothalamus and metabolic disorders on adipocyte may be the pathological bases which result~     in obesity. The research group have firstly conducted effect studies of massage therapy on~     model of simple obesity rats and observed some neurobiological mechanism (whole effect~     mechanism), meanwhile, the team have discussed influences on the development of preadipocyte~     and function of endocrine with dynamic mechanical stimulation in vitro (local effect~     mechanism). This research aims at centering on the hypothesis that massage therapy can act on~     energy regulation network system of hypothalamus specifically, thus regulating the energy~     metabolic disorders. Then applying functional magnetic resonance imaging (fMRI) to explore~     whether patients with simple obesity exist abnormality on energy regulation network system of~     hypothalamus, ascertain mechanisms how massage therapy treat energy metabolism disorders of~     simple obesity, deepen mechanism study on how massage therapy prevent and treat obesity and~     enrich the clinical application's scientific connotation that massage therapy treat simple~     obesity.~   "
93792|NCT02339467|"~     Community walking is an issue that older adults with chronic conditions have described as~     important to participation in the community. Walking outside the home is a universally~     accessible form of physical activity that has multiple health benefits. Walking for 150~     minutes per week can help reduce the risk of cardiovascular disease, hypertension, stroke,~     diabetes, osteoporosis, and depression, as well as falls. Practice walking across roads,~     slopes and curbs, while talking, and dealing with crowds and traffic, is safe and feasible~     and can improve confidence, balance and walking ability. Being physically active outdoors in~     nature appears to improve mental health more than being active indoors. Despite these health~     benefits, the majority of older Canadians do not walk outside on a regular basis. Barriers to~     walking outside include fear, physical disability due to chronic disease, the appropriateness~     of footwear and walking aids, and the physical environment, such as uneven pavement, weather~     and temperature. To date, the best strategy for getting people to walk outdoors regularly is~     unknown. The investigators propose to evaluate the effectiveness of a dynamic 1-day workshop,~     at which older adults who infrequently walk outdoors learn strategies to facilitate outdoor~     walking, such as appropriate use of footwear, ambulatory aids and equipment, goal setting,~     and practice skills related to increasing outdoor walking. The workshop will be compared to~     the workshop plus involvement in a walking group for 3 months. Outcomes include outdoor~     walking activity, total physical activity, walking ability, participation, and health-related~     quality of life. Each participant will have three evaluations: before the intervention and 3~     and 6 months later. The investigators will interview select participants at 6 months to ask~     them about their opinions of what worked and didn't work. Increasing outdoor walking is~     expected to improve health and well-being, and help people live independently in the~     community for longer.~   "
93793|NCT02339454|"~     Low intensity shockwaves have been proven in animal and pilot clinical studies to induce~     local growth of new blood vessels. Small single-center clinical trials with shockwave therapy~     showed promising results in reducing angina symptoms, improving perfusion and contractility~     in patients with refractory angina and stress-induced ischemia on imaging test.~      The hypothesis of this study is that shockwave therapy could improve angina symptoms and~     exercise tolerance in broader population of patients with stable angina regardless of imaging~     test results Study aims to demonstrate anti-anginal efficacy of Extracorporeal Shockwave~     Myocardial Revascularization Therapy (ESMR), on top of stable optimal medical treatment in~     patients with stable angina.~   "
93794|NCT02339441|"~     The aim of the study is to compare the effectiveness of commonly used immunosuppressant~     treatments for early diffuse cutaneous systemic sclerosis (SSc).~   "
93795|NCT02339428|"~     Patients will be randomized to receive diclophenac sodium or placebo two hours before~     diagnostic colonoscopy. Intensity of pain as measured on a 10-point Likert scale will be the~     primary outcome. Patients will be followed until hospital discharge, an average of 10 days.~   "
93796|NCT02339415|"~     The purpose of this study is to evaluate the effects of pharmacologic FXa inhibition (via~     edoxaban 30 mg daily) on inflammation, as reflected in plasma Interleukin-6 levels.~   "
93797|NCT02339402|"~     Developing a new non-invasive prenatal test for single gene disorders from cell free fetal~     DNA, retrieved from the mothers blood.~   "
93798|NCT02339389|"~     Epidural techniques offer the advantage of being able to titrate the level, density, and~     duration of the blockade through the use of a catheter and are associated with relative~     maternal hemodynamic stability. One of the disadvantages, however, include a raise in~     maternal temperature that is attributed to labor epidural technique. This study will assess~     if decreased maternal ventilation following induction of labor analgesia causes a raise in~     temperature.~   "
93799|NCT02339376|"~     The overall goal of this study is to open up the promising treatment of repetitive~     transcranial magnetic stimulation (rTMS), which has been shown to be effective against~     seizures in patients with surface neocortical foci, to a much larger population of patients~     with mesial temporal lobe epilepsy (MTLE) and other forms of epilepsy with deep foci, who are~     not currently considered good rTMS candidates.~      The investigators hypothesize that rTMS can modulate the hyperexcitable state in patients~     with deep seizure foci by targeting its usage to accessible cortical partner regions. In this~     study the investigators aim 1) to map the functional connectivity of the epileptogenic mesial~     temporal lobe in patients with medically refractory mesial temporal lobe epilepsy; and 2) to~     perform a randomized controlled assessment of repetitive transcranial magnetic stimulation~     protocols applied to specific neocortical targets in mesial temporal lobe epilepsy. The~     methods used in this study will include magnetic resonance imaging (MRI) of the brain,~     electroencephalography (EEG), and transcranial magnetic stimulation (TMS).~   "
93822|NCT02339064|"~     This is a Phase 3, multicenter, open-label, safety and tolerability study of continuous~     apomorphine infusion in subjects with advanced Parkinson's Disease (PD) whose motor~     fluctuations remain unsatisfactory with levodopa (or levodopa/carbidopa) and at least one~     other class of drugs or mode of therapy for PD.~   "
93802|NCT02339337|"~     This is an open label, randomized-controlled, comparative trial. HBV and HCV dually infected~     patients with negative hepatitis B e antigen (HBeAg) were enrolled in the study. The~     definition of HBV and HCV dual infection included seropositivity of HCV antibody (anti-HCV)~     and HBsAg for more than 6 months, together with positive serum HCV RNA. Eligible subjects~     were randomized into 2 groups at treatment initiation. Subjects who were randomized into the~     genotype guided therapy (GGT) group received Peg-IFN and standard dose RBV (1200 mg/day) for~     48 weeks in subjects infected with HCV genotype 1 or Peg-IFN and low dose RBV (800 mg/day)~     for 24 weeks in subjects infected with HCV genotype 2/3; the patients were then followed for~     6 months. For subjects who were randomized into the response guided therapy (RGT) group, the~     duration of Peg-IFN and RBV therapy was abbreviated to 24 weeks in subjects with HCV genotype~     1, a pre-treatment low viral load (LVL, < 400000 IU/mL) and RVR (defined asHCV RNA <50 IU/mL~     at 4th week of therapy); the duration was 16 weeks in subjects with HCV genotype 2/3 and RVR.~   "
93803|NCT02339324|"~     This study plans to to estimate the safety profile of the combination biotherapy regimen~     consisting of standard-dose interferon alpha-2b (HDI) and anti-PD1 monoclonal antibody,~     Pembrolizumab, for the neoadjuvant therapy of locally/regionally advanced/recurrent melanoma.~     Also, the objectives of this trial include the evaluation of prognostic and predictive~     biomarkers, radiologic preoperative response rate, pathologic response rate, progression free~     survival and overall survival. Up to 30 evaluable patients will be accrued.~   "
93804|NCT02339311|"~     One in three people will be diagnosed with diabetes by 2050, and the proportion will likely~     be higher among Native Americans. Diabetes control is currently suboptimal in underserved~     populations such as Zuni Indians despite a plethora of new therapies. Patient empowerment is~     a key determinant of diabetes control, but such empowerment can be difficult to achieve due~     to resource limitation and cultural, language and health literacy barriers. The investigators~     will conduct a home-based chronic disease (diabetes) educational intervention using Community~     Health Representatives (CHRs) to associate improvement in Patient Activation Measures scores~     (primary outcome) and clinical indicators of diabetes control (secondary outcomes).~   "
93805|NCT02339298|"~     The purpose of the study is to evaluate whether intraoperative music application has a~     positive impact on postoperative behavior in children and adolescents.~   "
93806|NCT02339285|"~     Investigating the effects of non-invasive transcranial alternating current stimulation (tACS)~     on patients with Major Depressive Disorder (MDD).~   "
93807|NCT02339272|"~     The aim of this study was to assess meiotic recombination in primary spermatocytes,~     synaptonemal complex length and the correlation with chromosomal abnormalities in testicular~     spermatozoa from infertile men with idiopathic non-obstructive azoospermia (NOA).~   "
93808|NCT02339259|"~     Background:~      The clinical features and prevalence of tropical rickettsial illnesses such as murine and~     scrub typhus in Bangladesh are unknown. Following testing for malaria, patients with~     undifferentiated fever are frequently treated empirically for typhoid or diagnosed clinically~     with a viral fever. Since murine and scrub typhus are common causes of fever in other~     countries in the region, it is likely they are prevalent in Bangladesh. Murine and scrub~     typhus may be treated cheaply and effectively with doxycycline.~      Primary aim:~      - Describe the clinical features of scrub and murine typhus in Bangladeshi patients~      Secondary aims:~        -  Assess the proportion of patients screened for malaria having rickettsial illnesses~        -  Understand the pathophysiology of severe scrub typhus and murine typhus~        -  Prospective evaluation of rapid diagnostic tests for scrub and murine typhus~      Methods:~      Scrub typhus and murine typhus rapid tests will be introduced to CMCH in conjunction with~     existing malaria testing facilities. Consenting febrile adult patients who have had malaria~     and typhus rapid tests and meeting the entry criteria will be enrolled. Samples will be saved~     for serology and real time polymerase chain reaction (PCR) testing for O. tsutsugamushi and~     Rickettsia spp. A thorough history and examination will be undertaken. Hemodynamic status~     will be assessed by ultrasound upon enrolment. Patients will be followed up for outcome and a~     second sample will be taken for convalescent serological testing on day 14 where possible.~      Analysis The proportion of patients screened for malaria with an acute febrile illness due to~     scrub typhus and murine typhus will be calculated. The clinical features of scrub and murine~     typhus, malaria and patients negative for these conditions will be compared. Healthy subject~     samples will be used to provide normal ranges. The sensitivity and specificity of the rapid~     tests will be assessed as compared to the gold standard of PCR and serology combined.~   "
93809|NCT02339246|"~     The purpose of the study is to compare the pharmacokinetic parameters of three different~     formulations of tacrolimus.~      Eligible patients will be treated with all three formulations in a pre-defined sequence.~   "
93810|NCT02339233|"~     The overall aim is to assess whether task specific locomotor training and spinal cord~     electrical stimulation (SCES) can induce neural reorganization of the functionally isolated~     human spinal cord to improve standing and stepping in individuals with functionally complete~     SCI. The investigators propose that locomotor training will result in generation of more~     effective standing and stepping efferent patterns by restoring phase dependent modulation of~     reflexes and reciprocal inhibition, reducing clonus and mediating interlimb coordination. The~     investigators propose that the SCES will optimize the physiological state of the spinal cord~     interneuronal circuitry compromised by compensating for loss of supraspinal input for the~     retraining of these tasks.~   "
93811|NCT02339220|"~     The purpose of this study is to determine the value of Constraint-Induced Movement therapy~     (CIMT) for improving motor function and general fitness in adults with subacute and chronic~     traumatic brain injury (TBI), particularly TBI acquired during active military duty, in~     comparison to a Lakeshore Enriched Fitness Training (LEFT). The study will also test the~     effect of a set of enhanced versus standard procedures for transferring therapeutic gains~     from treatment setting to everyday life. Lastly, this study will determine whether any~     therapeutic effects observed are correlated with neuroplastic white matter or grey matter~     changes.~   "
93812|NCT02339207|"~     This randomized, double-blind, placebo-controlled, 3-part study will assess the safety,~     tolerability, and pharmacokinetics of orally administered AL-335 in healthy volunteers (HV)~     and subjects with CHC infection.~   "
93823|NCT02339051|"~     Osteoporosis is a large public health disease, characterized by low bone mass and micro~     architectural deterioration of bone tissue, resulting in enhanced bone fragility and~     consequent increase in fracture risk. Osteoporosis is present when bone mineral density (BMD)~     or content (BMC), measured by dual-energy X-ray absorptiometry (DXA), is more than 2.5 SDs~     below the mean value of the young adult. BMD measured by DXA is a surrogate measure of bone~     strength and is the primary determinant of fracture risk in both men and women. However, the~     majority of fragility fractures occur in women and in individuals who do not have~     osteoporosis according to these standards, indicating that BMD is just one among several~     indicators of bone health and that assessment of fracture risk should also rely on other bone~     properties. Newer imaging methods, such as quantitative computerized tomography (QCT), can~     complement information from DXA-measurements due to its ability to assess volumetric BMD and~     bone geometry and to differentiate between cortical and trabecular bone compartments. Bones~     are composite materials made predominantly of living cells, extracellular matrix, water and~     lipids. This composite nature of the bone material enables it to absorb stresses by elastic~     deformation and to endure high loads before fracturing. A new in vivo measurements of bone~     material strength can be used to evaluate bone mechanical properties and thereby the fracture~     risk. It is well established that the skeleton benefits, in terms of increased density, from~     regular physical activity. However, changes in BMD are still the main surrogate for assessing~     improvements in exercise-induced bone health despite the experimental findings as well as~     findings in humans showing that improvements in mechanical bone properties are independent of~     changes in BMD. These improvements in mechanical bone properties may be due to changes in~     bone shape or matrix composition. It could then be argued that a decrease in BMD is only one~     of the possible manifestations of osteoporosis and that bone strength or fragility is~     multifactorial. The objective for this study is to investigate the role of mechanical loading~     on bone material strength and bone microarchitecture in middle-aged women. The overall~     hypothesis is that mechanical loading is a regulator of bone material strength and~     microarchitecture in middle-aged women. This is an intervention study where the participants~     will act as their own controls. The investigators intend to include 40 postmenopausal and~     healthy women 50-60 years of age in the study. Advertisements in local papers and at the~     hospital will be used to come into contact with suitable study subjects. The women will be~     asked to perform an intervention program, including jumping on one leg every day during a~     3-month period according to a protocol with a gradually increasing load/number of jumps. The~     women have to choose one of their legs as intervention-leg and stick to the chosen leg~     throughout the study. The leg without intervention will be used as a control. Both bone~     material strength (BMS) and bone microarchitecture will be measured before and after~     intervention in both legs (tibia). The operators measuring BMS (OsteoProbe®) and bone~     microarchitecture (high resolution pQCT) will be blinded concerning each participant's choice~     of leg for intervention. In addition, subjects will be asked to register daily physical~     activity in a structured diary. The primary outcome measure will be changes in bone material~     strength (BMS) in the lower leg (tibia) with intervention compared to the leg (tibia) without~     intervention. Participants will attend two clinic visits, at baseline and after 3 months when~     the intervention period is completed. The secondary outcome measures will be changes in total~     volumetric density, cortical volumetric density, cortical cross sectional area and trabecular~     bone volume fraction in the lower leg (tibia) with intervention compared to the leg (tibia)~     without intervention.~   "
93864|NCT02338518|"~     Chemotherapy is an important therapeutic method for unresectable gastric cancer patients.~     However, there is currently no established standard chemotherapeutic regimen for gastric~     cancer. The aim of our study was to compare the efficacy and toxicity between SEEOX and SOX~     regimens. The investigators estimate that combined intravenous and intra-arterial intensified~     SEEOX neoadjuvant chemotherapy may be a safe and promising regimen in unresectable gastric~     cancer patients.~   "
93865|NCT02338505|"~     Phase II prospective single-institutional study.~   "
93866|NCT02338492|"~     This study will collect safety and performance data of the Photodynamic Bone Stabilization~     System (PBSS) when used for the treatment of fractures of the humerus secondary to metastatic~     cancer.~   "
93813|NCT02339194|"~     BACKGROUND: The literature has shown that simplified methods for complete denture fabrication~     can be as effective as the traditional techniques, but with less expenditure of time and~     resources, without prejudice to the patients. However, the effectiveness of these simplified~     methods for patients with more complex medical conditions haven't been deeply explored.~      OBJECTIVES: To evaluate the effectiveness of a proposed simplified method for complete~     dentures fabrication for patients with severely resorbed mandibular alveolar bones.~      METHOD: edentulous patients requesting treatment with bimaxillary complete dentures in a~     university clinic will be rehabilitated following a simplified technical proposal, being~     divided randomly into two groups according to the mandibular arch molding technique. In group~     A, a single impression with alginate through pre-fabricated trays will be performed, while~     patients allocated in group B will receive a second molding with a more complex technique.~     After 3 and 6 months, besides important clinical parameters, it will be investigated aspects~     related to patient's perceptions about the success of treatment. The study will be conducted~     with a minimum of 30 participants per group, and comparisons between the two groups will be~     made by means of tests suitable for distribution of data.~   "
93814|NCT02339168|"~     This phase I trial studies the side effects and best dose of metformin hydrochloride when~     given together with enzalutamide in treating patients with prostate cancer that has not~     responded to previous treatment with hormones. Hormone therapy using enzalutamide may fight~     prostate cancer by lowering the amount of androgens the body makes and blocking the use of~     androgens by the tumor cells. Metformin hydrochloride, used for diabetes, may also help kill~     tumor cells. Giving enzalutamide together with metformin hydrochloride may kill more tumor~     cells.~   "
93815|NCT02339155|"~     This study, as a post-marketing commitment to the Food and Drug Administration, is designed~     to detect the effect of raxibacumab on anthrax vaccine adsorbed (AVA) immunogenicity in a~     healthy volunteer population. This is a randomized, open-label, parallel group, two arm study~     to compare the immunogenicity of AVA at 4 weeks after the first AVA dose, when AVA is~     administered alone or concomitantly with raxibacumab. The study is planned to enroll~     approximately 30 to 534 subjects in up to 3 cohorts. The total duration of the study will be~     approximately 26 weeks. The dates reflect cohort 1.~   "
93816|NCT02339142|"~     Thyroid eye disease is an autoimmune disorder affecting approximately 50% of individuals with~     autoimmune thyroid diseases resulting in enlargement of ocular muscles and may lead to~     congestion of the eyelids and ocular surface, ocular movement restriction and double vision,~     and optic nerve compression and loss of vision.~      First line medical therapy is oral or intravenous corticosteroids (CS), which several studies~     have shown results in reduction of soft tissue congestion, but some studies suggesting that~     ocular restriction or visual loss may still occur in spite of CS therapy.i~      External beam radiotherapy (XRT) is second line therapy but is controversial, with some~     studies suggesting benefit in preventing onset of double vision or optic nerve compression~     while other studies suggest it has no benefit. Most proponents of XRT for TED believe that it~     is most effective early in the disease evolution. XRT has been shown to be a safe therapy~     with few side-effects, although retinopathy changes have developed in a small percentage of~     diabetics and its use is avoided for diabetics.~      Combined oral prednisone and XRT has been shown to be more effective in reducing soft tissue~     inflammation and motility complications than either monotherapy in two different studies.~      To date there have been no trials comparing combined XRT and iv CS with iv CS alone for early~     progressive TED to identify potential benefit in reducing the severity of motility disorders~     or preventing the onset of dysthyroid optic neuropathy. That is the purpose of this study.~   "
93817|NCT02339129|"~     This is a Phase 2, prospective, randomized, dual-center, double-blind, placebo-controlled,~     parallel-group study designed to determine the dosing interval, efficacy and safety of~     SST-0225 (5.4 grams, applied up to 6 times in 24 hours, over a 48-hour dosing period) for the~     treatment of pain associated with DOMS.~   "
93818|NCT02339116|"~     Bev improves the efficacy of first-line chemotherapy in unresectable mCRC. In the phase III~     TRIBE trial upfront FOLFOXIRI plus bev provided a significant advantage in terms of PFS and~     RR compared to FOLFIRI plus bev. A trend toward better OS was also evidenced. The second-line~     treatment was at investigator's choice. A manageable increase in diarrhea, mucositis and~     neutropenia was reported, while no differences in febrile neutropenia, serious adverse events~     and toxic deaths were evidenced.~      A growing amount of data support the clinical relevance of achieving an early and deep tumor~     shrinkage.~      Phase III TML and BEBYP trials demonstrated that the continuation of bev beyond disease~     progression combined with a switched chemotherapy regimen provided a significant advantage in~     terms of OS and PFS.~      Based on recent evidences, the partial interruption of the upfront induction chemotherapy~     before disease progression and the prosecution of bev until disease progression as~     maintenance treatment is a valid strategy in the treatment of mCRC.~      On the basis of these considerations, a first-line doublet plus bev followed by a second-line~     switched doublet (from oxaliplatin to irinotecan and viceversa) plus bev should be considered~     a standard option for mCRC patients. Only retrospectively collected data are currently~     available about the efficacy of first-line FOLFOXIRI plus bev followed by second-line~     rechallenge with FOLFOXIRI plus bev. We therefore designed the present phase III randomized~     trial of first-line FOLFOXIRI plus bev followed by reintroduction of FOLFOXIRI plus bev at~     progression versus FOLFOX plus bev followed by FOLFIRI plus bev at progression in first- and~     second-line treatment of unresectable mCRC patients.~   "
93819|NCT02339103|"~     The purpose of this study is to compare two novel active rewarming techniques in mildly~     hypothermic people. Volunteers will undergo 3 cooling trials in a circulating bath at 14~     degrees celsius and will then be rewarmed with either shivering alone, warmed iv fluids~     (IVF), or water perfusion pads applied to the hands and feet. The investigators hypothesize~     that both heated IVF and water perfusion pads to the arteriovenous anastomoses (AVAs) will~     prove to provide significantly superior rewarming rates than shivering alone.~   "
93820|NCT02339090|"~     The trial will compare a twice-monthly somavaratan dosing regimen for non-inferiority of~     treatment effect against daily injections of rhGH.~   "
93821|NCT02339077|"~     This is a descriptive study to determine the role of fetal GBS disease as a cause for~     stillbirths~   "
93824|NCT02339038|"~     Background:~      - Treatment for Hepatitis C has changed a lot in the past 2 years. Most of this change comes~     from a combination of medicines that is yielding high cure rates. But its long-term effects~     are uncertain. One problem is that a lot of people need the treatment, but only a few~     specialists can give it. The success rate for Hepatitis C treatment by primary care doctors,~     nurse practitioners, or physician assistants is largely unknown. Researchers want to see how~     provider type affects treatment outcomes. They will conduct a large, community-based study in~     the District of Columbia.~      Objectives:~      - To see if people can be treated for Hepatitis C safely and successfully in community-based~     health centers.~      Eligibility:~      - Adults who need treatment for chronic Hepatitis C infection.~      Design:~        -  Participants will be screened with blood tests. Their current medicines will be~          reviewed.~        -  Participants will give researchers access to their medical records. Researchers will~          follow participants through these records.~        -  Participants will see a primary care or infectious disease provider. The provider will~          tell them about their treatment. They will be told how often they will visit the~          provider and how often they will have their blood drawn. They will get a calendar of~          study visits.~        -  Participants will take Harvoni for 8, 12, or 24 weeks. They will visit their care~          provider monthly.~        -  Participants will have monthly follow-up visits for up to 3 months after they finish~          their medicine.~        -  Participants will have yearly follow-up visits with their care provider for up to 10~          years.~   "
93825|NCT02339025|"~     Background:~      - Researchers at the National Cancer Institute and the Department of Defense are trying to~     learn more about what causes cancer, heart disease, and other health problems. To do this,~     they gather data on risk factors and biological markers. They get these data from large~     groups of people in long-running studies. As these groups of people age, researchers must~     form new groups. TRICARE is a health insurance program for uniformed service members and~     their families. It is a major part of the Military Health System. Researchers hope to form a~     new study group from TRICARE members. This study will test if TRICARE members will take part~     in a research study.~      Objectives:~      - To test if TRICARE members will take part in a research study.~      Eligibility:~      - TRICARE members aged 35 74 with military primary care providers at Walter Reed National~     Military Medical Center. They must not have a prior diagnosis of cancer other than~     non-melanoma skin cancer.~      Design:~        -  Participants will fill out a survey. It will ask about their risk factors for cancer and~          other chronic diseases. Their medical records will be reviewed. They will give a blood~          sample.~        -  If a larger study is formed, then participants data will be used in the larger study.~          They may be asked to give more samples.~   "
93826|NCT02339012|"~     Background:~      - Biomarkers are substances in people s blood and tissues. They help researchers understand~     diseases and signs of aging. Scientists want to do more research on biomarkers to find ways~     to improve quality of life in old age.~      Objective:~      - To learn more about biomarkers and their relationship to aging.~      Eligibility:~      - Adults at least 20 years old who weigh at least 110 pounds and have a body mass index below~     30. They must agree that their genetic samples can be collected, studied, and stored.~      Design:~        -  Participants will be screened with medical history, physical exam, and blood and urine~          tests. They will have heart tests and nurse will assess their veins. They will fill out~          a questionnaire.~        -  Participants will have a 2-day baseline visit. Then they will return every 2 years for~          up to 10 years. These follow-up visits will repeat the baseline visit:~        -  Repeat of screening procedures.~        -  Physical performance tests like balance and walking tests.~        -  Leg and grip strength tests.~        -  Health and mental state questions.~        -  Memory and problem solving tests.~        -  Cytapheresis. Blood will be removed through a needle in the vein of one arm and run~          through a machine. The blood will be returned through a needle in a vein of the other~          arm.~        -  Visits may also include:~        -  Magnetic resonance imaging scans. Participants will lie on a table that slides in and~          out of a machine that takes pictures.~        -  Diabetes test. After fasting, participants will drink a sweet drink and give blood.~        -  Breathing and walking tests.~        -  Wearing a device that record physical activity.~        -  Scan of the abdomen and the right leg.~        -  A small amount of muscle tissue and/or skin removed.~   "
93827|NCT02338999|"~     Background:~      - Lupus causes a person s immune system to attack the body. It can cause blood vessel~     problems, heart attack, or stroke. Researchers want to see if the drug pioglitazone may help.~      Objectives:~      - To see how well pioglitazone improves blood vessel function and decreases blood vessel~     inflammation. To study its effect on lupus symptoms.~      Eligibility:~      - Adults at least 18 years old with lupus.~      Design:~        -  Participants will be screened with medical history, heart test, and blood and urine~          tests. They may have a bone density test.~        -  Visit 1:~        -  Participants will have:~        -  Physical exam and blood drawn.~        -  Peripheral Arterial Tonometry (Endopat). A cup will be placed on the finger and a~          pressure cuff on the arm.~        -  Cardio-ankle vascular index (CAVI) and/or Sphygmocor. Electrodes will be placed on both~          wrists, a microphone on the chest, and a blood pressure cuff on each arm and leg.~          Another test will involve placing a small device on a fingertip.~        -  18-Fluorodeoxyglucose (FDG) positron emission tomography/computerized tomography~          (PET/CT) (some participants). A radioactive sugar will be injected into a small plastic~          tube in an arm vein. Participants will lie on a bed that moves in and out of a scanner~          that takes pictures.~        -  Participants will get a 3-month-supply of the study drug or placebo. After 1 week, their~          dose may increase.~        -  After those 3 months, they will not take either drug for 8 weeks. Then they will switch~          and take the other drug for 3 months.~        -  Participants will have 6 more visits over 8 months after Visit 1. Tests from Visit 1 may~          be repeated. They may have a urine test.~   "
93860|NCT02338570|"~     Evaluation of unfavourable outcome-related factors in patients affected by renal cell cancer~     in treatment with everolimus and previously treated with a Vascular endothelial growth factor~     (VEGF) inhibitor (i.e. sunitinib, sorafenib,pazopanib, or bevacizumab+interferon)~   "
93912|NCT02337894|"~     The purpose of this study is to assess the effect of an eight-week dietary supplementation~     with essential amino acids plus arginine on liver and plasma lipid content, whole-body fat~     oxidation, whole-body insulin sensitivity, whole body protein metabolism, and body~     composition in obese pre-pubertal children.~   "
93828|NCT02338986|"~     Background:~      - There are more emerging infectious diseases recently. Some could affect many people. Some~     like Severe Acute Respiratory Syndrome (SARS) or Middle East Respiratory Syndrome (MERS) are~     caused by new germs. Sometimes known germs suddenly infect new and large areas, like Ebola.~     Many of these diseases don t have good treatments available. Researchers may be able to~     develop a treatment by using antibodies against these infections.~      Objective:~      - To collect antibodies from people with high levels of antibodies to the diseases being~     studied.~      Eligibility:~      - Healthy men 18-70 years old who weigh at least 110 pounds. They may have been infected with~     or vaccinated for one of the new infections researchers are studying.~      Design:~        -  Participants will be screened with medical history and blood tests. Researchers will~          determine if the participant can have apheresis.~        -  Participants will have apheresis. First, they will be interviewed. Then, a needle will~          be placed in a vein. Blood will be drawn, and a machine will separate the blood cells~          from the antibodies and protein. The blood cells will then be returned to the~          participant through another vein. It takes about 60 minutes for the actual collection.~        -  Participants will be asked to have the procedure at least 3 times. They can participate~          in up to 20 sessions total as part of this study. There must be at least 7 days between~          sessions.~   "
93829|NCT02338973|"~     Background:~      - People with rod-cone dystrophy (RCD) or enhanced S-cone syndrome (ESCS) have excess fluid~     under the retina of their eye. This can cause vision loss. The medicine interferon gamma-1b~     may help people with these diseases.~      Objectives:~      - To see if interferon gamma-1b eyedrops are safe for people with RCD or ESCS. To see if the~     medicine can decrease retina fluid and help prevent vision loss.~      Eligibility:~      - People at least 12 years old with RCD or ESCS. Those with ESCS must have two mutations in~     the NR2E3 gene.~      Design:~        -  Participants will be screened with medical history, physical exam, eye exam, and blood~          tests.~        -  Participants will stay at NIH for 2 days and get the first eyedrops.~        -  Participants will give themselves 4 study eyedrops 4 times daily for 2 weeks and keep a~          diary.~        -  Participants will have 2 phone calls and 5 outpatient visits over 8 weeks. They may~          have:~        -  Repeats of screening tests.~        -  Questionnaires.~        -  Small piece of skin removed.~        -  Eye exams, including eye dilation and tasks on computer screens.~        -  Fluorescein angiography. A dye injected into an arm vein will travel to the blood~          vessels in the eyes. A camera will take pictures.~        -  Electroretinography. Participants will sit in the dark wearing eyepatches. A small~          electrode will be taped to the forehead. After 30 minutes, researchers will remove the~          eyepatches and put in numbing eyedrops and contact lenses. Participants will watch~          flashing lights.~        -  Electrooculography. Electrodes will be attached outside of the eyes and eye function~          will be measured in the dark and the light.~        -  Participants will have a follow-up visit after 52 weeks.~   "
93830|NCT02338960|"~     A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an~     Open-label Extension to evaluate the efficacy of bremelanotide (BMT), administered~     subcutaneously (SC) on an as needed basis for the treatment of HSDD (with or without~     decreased arousal) in premenopausal females.~   "
93831|NCT02338947|"~     Introduction:~      Advances in modern medicine have led to people living longer and healthier lives. Frailty is~     an emerging concept in medicine yet to be explored as a risk factor in cardiac surgery. When~     it comes to CABG surgery, randomized controlled clinical trials have primarily focused on~     low-risk (ROOBY, CORONARY), elevated-risk (GOPCABE) or high-risk patients (BBS), but not on~     frail patients.~      Therefore, we believe that off-pump CABG could be an important technique in patients with~     limited functional capacity to respond to surgical stress. In this study, the authors~     introduce the new national, multicenter, randomized, controlled trial FRAGILE, to be~     developed in the main cardiac surgery centers of Brazil, to clarify the potential benefit of~     off-pump CABG in frail patients.~      Methods:~      FRAGILE is a two-arm, parallel-group, multicentre, individually randomized (1:1) controlled~     trial which will enroll 630 patients with blinded outcome assessment (at 30 days, 6 months, 1~     year, 2 years and 3 years), which aims to compare adverse cardiac and cerebrovascular events~     after off-pump versus on-pump CABG in pre-frail and frail patients. Primary outcomes will be~     all-cause mortality, acute myocardial infarction, cardiac arrest with successful~     resuscitation, low cardiac output syndrome/cardiogenic shock, stroke, and coronary~     reintervention. Secondary outcomes will be major adverse cardiac and cerebrovascular events,~     operative time, mechanical ventilation time, hyperdynamic shock, new onset of atrial~     fibrillation, renal replacement therapy, reoperation for bleeding, pneumonia, length of stay~     in intensive care unit, length of stay in hospital, number of units of blood transfused,~     graft patency, rate of complete revascularization, neurobehavioral outcomes after cardiac~     surgery, quality of life after cardiac surgery and costs.~      Discussion:~      FRAGILE trial will determine whether off-pump CABG is superior to conventional on-pump CABG~     in the surgical treatment of pre-frail and frail patients.~   "
93832|NCT02338934|"~     This is a single arm, open-labelled study to determine the effectiveness of combination~     Cinacalcet with Vitamin D analogue in the treatment of severe hyperparathyroidism in patients~     with ESRF on haemodialysis. Patients will be started on PO Cinacalcet 25mg OD + PO/IV active~     Vitamin D analogues adjusted by increments/decrements in steps of 1 mcg 3x per week every 1-4~     weeks until the corrected calcium level is within 2.4-2.54 mmol/L. After iPTH has reached~     2-9x ULN, patient enters maintenance phase. If serum calcium falls below 2.1mmol/L, active~     Vit D dose will be increased and if it is above 2.54 mmol/L, the dose will be decreased.~      Percentage reduction of iPTH levels from baseline at 6,12 and 24 months treatment and~     Percentage of patients achieving iPTH levels within the target range of 2-9x upper limit~     normal at 6, 12 and 24 months will be determined~   "
93833|NCT02338921|"~     To assess the efficacy of treatment with sitagliptin or dapagliflozin or lobeglitazone in~     type 2 diabetes mellitus patients, who had inadequate glycemic control even though use of two~     drug combination therapy with glimepiride and metformin.~   "
93834|NCT02338908|"~     Shoulder pain is highly prevalent in the society. The role of muscle tissues in this~     pathology has received increasing interest. Some studies have proposed the role of myofascial~     trigger points in this population. The purpose of the current clinical trial is to compare~     the effects of physiotherapy treatment consisting of an eccentric exercise protocol versus~     the same physical therapy program plus the addition of trigger point dry needling (TrP-DN) on~     pain and function in patients suffering from unspecific shoulder pain.~   "
93867|NCT02338479|"~     This is a prospective non-therapeutic study, assessing the long-term toxicity of pediatric~     HCT for hematologic malignancies. This study is a collaboration between the Pediatric Blood~     and Marrow Transplant Consortium (PBMTC), the Center for International Blood and Marrow~     Transplant Research (CIBMTR), the National Marrow Transplant Program (NMDP) and the Resource~     for Clinical Investigation in Blood and Marrow Transplantation (RCI-BMT) of the CIBMTR. The~     study will enroll pediatric patients who undergo myeloablative HCT for hematologic~     malignancies at PBMTC sites.~   "
93835|NCT02338895|"~     Acute Kidney Injury (AKI) develops in 88% to 30% of critically ill patients admitted to an~     intensive care unit and is a strong predictor of mortality.Therefore any management strategy~     that prevents progression of renal risk to injury or failure has the potential to improve~     outcomes in these patients.Conventional management of acute oliguria in shock has been to~     blindly 'push' fluids to improve renal perfusion or to give loop diuretics once fluid loading~     has been considered as accomplished. However both volume overload and 'blind' attempts at~     fluid removal can worsen renal injury and have been associated with higher mortality by~     venous overcongestion and inappropriate hypovolemia. It seems reasonable to assume that a~     bedside test to visualize volume status and renal perfusion may assist in improving outcomes~     in this cohort.The investigators developed a goal-directed ultrasonographic protocol to~     provide immediate hemodynamic information in acutely oliguric patients with shock as well as~     a management algorithm for guiding therapy. The investigators incorporated IVC diameter~     measurement, respiratory variation and response to a passive leg raise to assess whether~     further fluid boluses were required and a measurement of renal perfusion to determine whether~     diuretics or renal replacement therapy were indicated. The investigators aim to measure the~     effects of this management protocol on the rates of AKI in the study participants as compared~     to prior to the implementation of the protocol.The study design is a prospective,~     observational. Since this is a proof of concept study, the projected sample size is 40~     patients. An interim analysis will be carried out after 20 patients are enrolled and a~     further 20 will be enrolled as necessary~   "
93836|NCT02338882|"~     During cataract surgery an artificial lens is implanted in the eye. These artificial lenses~     are called intraocular lenses (IOLs) and there are many different types of IOL designs. IOLs~     are of fixed focus and so unless a multifocal IOL is used you would need to wear spectacles~     for viewing near objects. This study has been designed to look at how well a multifocal IOL~     corrects distance and near vision in comparison with a conventional monofocal IOL. Both types~     of IOLs are commercially available and are commonly implanted. Using new non-invasive methods~     we hope to be able to better judge the visual performance of these IOLs. In addition the~     study will involve imaging and examining the IOLs to determine the prevalence of any~     post-operative complications.~   "
93837|NCT02338869|"~     Multicenter randomized controlled trial (RCT) testing the effect of a dialogue-based~     psychosocial intervention for stroke acute survivors in primary care one to six months~     poststroke. Primary outcome is psycho-social health and wellbeing, measured by GHQ28 (primary~     outcome) and SAQoL (secondary outcome). 400 stroke survivors are randomized into intervention~     group or control group. Patients are followed up for 12 months.~   "
93838|NCT02338856|"~     The purpose of this study is to investigate the safety and tolerability of MB12066 after~     multiple dose and to investigate the pharmacokinetic characteristics of MB12066 after~     multiple dose.~   "
93839|NCT02338843|"~     This is a Phase 3, double-blind, randomized study of LJPC-501 (angiotensin II) in adult~     patients diagnosed with catecholamine-resistant hypotension (CRH) conducted in multiple~     centers globally.~   "
93840|NCT02338830|"~     To evaluate the value of vaginal progesterone therapy for reduction of preterm labor in~     asymptomatic twin pregnancies who have sonographic short cervix~   "
93841|NCT02338817|"~     Glycogen storage disease (GSD) patients frequently experience periods of hypoglycemia,~     putting them at risk for several complications, such as hepatomegaly, adenomas, and~     cirrhosis. As of now, glycogen storage disease patients are limited to using finger stick~     glucose meters to monitor their glycemia at home. Diabetes Sentry, a non-invasive~     hypoglycemia detector designed like a watch, has been available for diabetic patients to~     non-invasively alert for hypoglycemia, but has never been tested in a GSD population. The~     investigators propose to test the accuracy of the Diabetes Sentry on patients with GSD types~     0, I, III, VI, and IX, by measuring their metabolic markers every two hours, as well as~     whenever the device alerts for hypoglycemia. If accurate, it could be a useful tool for GSD~     patients in managing hypoglycemia, both clinically and at home.~   "
93842|NCT02338804|"~     The purpose of this study is to evaluate the safeness and effectiveness of mix vaccine (MV).~     Enrolled patients will receive standard treatment according to National Comprehensive Cancer~     Network (NCCN) guide line with or without combining MV injection. The efficacy and side~     effect will be compared between the two groups.~   "
93843|NCT02338791|"~     The purpose of this study is to measure the amount of movement between the bones of the~     shoulder joint when mobilization techniques are applied by a physical therapist.~   "
93844|NCT02338778|"~     The purpose of this study is to evaluate the safeness and effectiveness of mix vaccine (MV).~     Enrolled patients will receive standard treatment according to National Comprehensive Cancer~     Network (NCCN) guide line with or without combining MV injection. The efficacy and side~     effect will be compared between the two groups.~   "
93845|NCT02338765|"~     The purpose of the 12-week study is to determine if competing a physical activity program~     with a buddy helps increase daily physical activity when compared to completing the same~     physical activity program without a buddy.~   "
93846|NCT02338752|"~     The purpose of this study is to evaluate the safeness and effectiveness of mix vaccine (MV).~     Enrolled patients will receive standard treatment according to National Comprehensive Cancer~     Network (NCCN) guide line with or without combining MV injection. The efficacy and side~     effect will be compared between the two groups.~   "
93861|NCT02338557|"~     Study was conducted Effectiveness of Motor Relearning Programme and Mirror Therapy along with~     Conventional Physiotherapy treatment for improving Hand Function In Patients with stroke.~     study was an experimental study conducted on 12 stroke patients using convenient sampling~     method .Subjects were divided into two equal groups (n=6). Group A was given conventional~     physiotherapy and Motor Relearning Programme exercises for the affected hand and Group B~     received conventional physiotherapy for the affected hand and mirror therapy for the~     unaffected hand. Chedoke arm and hand inventory (CAHAI) was used as primary outcome measure~     for evaluation of hand function before and after application of therapeutic Intervention~   "
93862|NCT02338544|"~     The purpose of this observational trial is to assess application and convenience of Epiduo®~     PUMP under daily clinical practice conditions in patients with moderate to severe~     inflammatory acne.~   "
93847|NCT02338739|"~     Retaining HIV-infected patients in care is critical, but loss to follow-up after enrolment~     often reaches 20%-40% by two years, placing millions of patients at risk of poor outcomes. A~     strategy to optimize retention within resource constraints is urgently needed. Sequential~     adaptive strategies - a novel class of public health approaches - may offer a solution. A~     candidate sequential adaptive strategy would start with a less expensive intervention (e.g.,~     SMS) in all patients and then apply a more costly and intensive one (e.g., navigator) only to~     patients who show early signs of poor retention. This study involves a sequential multiple~     assignment randomized trial to evaluate a family of such strategies. the investigators will~     randomize 1,800 adults newly initiating antiretroviral treatment (ART) at 4 HIV clinics in~     the Nyanza region of Kenya to (1) standard of care routine education and counselling (REC),~     (2) SMS text messages, or (3) transport vouchers. Patients with early signs of weakening~     retention (defined as the first time a patient is 14 days late for an appointment) will be~     re-randomized to (1) a single episode of outreach (standard of care), (2) SMS combined with~     vouchers, or (3) a peer navigator. Patients not successfully contacted by 28 days after~     missed visit (and not verified to have left the area or transferred to another clinic) will~     also be rerandomized to of one the same three re-engagement interventions. Individuals~     randomized at first stage to SMS or voucher that do not miss a visit by at least 14 days in~     the first 12 months of follow up will be re-randomized at 12 months to stop first stage~     intervention or continue with that same intervention to 24 months. The investigators primary~     objective is to assess the comparative effectiveness of sequenced intervention strategies to~     prevent initial lapses in retention and to treat those that occur. The investigators primary~     endpoint is fraction of time retained in care two years after enrolment. In addition, the~     investigators will assess the comparative effectiveness of first-stage strategies (REC, SMS,~     voucher) to prevent lapses in retention, and the comparative effectiveness of second stage~     strategies (outreach, SMS + voucher, navigator) to re-engage patients after initial lapse.~     This study will also compare outcomes among patients who continue versus discontinue the SMS~     and voucher interventions, including a small complementarity component utilizing qualitative~     methods to examine the voucher approach and the effects of discontinuing this approach after~     success among a subset of participants. At study conclusion the investigators output will be~     a menu of adaptive strategies for retention, accompanied by estimates of cost and~     effectiveness, which policy makers in different settings can use to advance the impact of HIV~     care and treatment programs in Africa.~   "
93848|NCT02338726|"~     To assess pelvic floor symptoms and quality of life in elderly women.~   "
93849|NCT02338713|"~     The purpose of this study is to demonstrate that the intestinal absorption of calcium from a~     novel calcium carbonate-vitamin D3 chewable tablet formulation (calcium 500 milligrams (mg)~     and vitamin D3 1000 International Units (IU)) increases the amount of calcium excreted in~     urine and decreases parathyroid hormone (PTH) in serum as compared with Baseline.~   "
93850|NCT02338700|"~     The purpose of this study is to evaluate the safeness and effectiveness of mix vaccine (MV).~     Enrolled patients will receive standard treatment according to National Comprehensive Cancer~     Network (NCCN) guide line with or without combining MV injection. The efficacy and side~     effect will be compared between the two groups.~   "
93851|NCT02338687|"~     The purpose of this study is to assess, in pregnant women with calcium-poor diets, what is~     the effectiveness of low-dose (500 mg/day) calcium supplements associated with an educational~     intervention, compared to the educational intervention alone, in the prevention of~     preeclampsia and hypertensive disorders during pregnancy.~   "
93852|NCT02338674|"~     Patients with chronic hepatitis B infection (CHI) awaiting assisted reproduction usually~     require antiviral therapy due to vertical transmission risk and laboratory safety. However,~     no consensus is reached regarding the medication. This study aimed to explore the efficacy~     and safety of tenofovir (TDF) and telbivudine (LdT) in this population.~   "
93853|NCT02338661|"~     This study is a prospective, single-center, postmarket clinical observation to observe the~     clinical and radiographic long-term performance of the SBG hip stem.~   "
93854|NCT02338648|"~     The purpose of this study is to evaluate the efficacy and safety of SUN-131 1.5% TDS as~     compared with placebo TDS in the treatment of chalazion based on the proportion of subjects~     that have complete response. Complete response is defined as the absence of any significant~     clinical signs of a chalazion with possible scaring or skin defects resulting from healing of~     the chalazion allowed.~   "
93855|NCT02338635|"~     Peritoneal fibrosis is one of the major causes of technical failure in patients on peritoneal~     dialysis (PD) for long period of time. Although the exact mechanisms of peritoneal damage~     during PD still remain unclear, generation of Endoplasmic reticulum (ER) stress may be~     responsible for progressive membrane dysfunction. Ursodeoxycholic acid (URSA) is a powerful~     inhibitor of ER stress to protect peritoneal fibrosis in peritoneal dialysis in the~     investigators in-vitro study. In this study the researchers investigated the hypothesis that~     URSA protect peritoneal membrane damage.~   "
93856|NCT02338622|"~     This is a phase I trial of the combination of the PARP inhibitor olaparib and AKT inhibitor~     AZD5363.~      There are two parts to this study. Part A: dose escalation, and Part B: dose expansion.~      Part A will investigate the combination of 300 mg bd of olaparib with intrapatient ascending~     doses of AZD5363 administered for either 4-days-on, 3-days-off, and 2-days-on, 5-days-off.~      Once the Maximum Tolerated Dose (MTD) is reached for both arms (or under the advice from the~     Safety Review Committee (SRC) one of the schedules will be discontinued), the schedule with~     the optimum safety and PK/PD profile will be taken forward to a dose expansion phase (Part~     B).~      Part B will evaluate the optimized dose/schedule identified in Part A of the study in~     patients with (1) BRCA1/2 mutant cancers (with previous disease progression on PARP inhibitor~     monotherapy), or (2) advanced sporadic tumours (e.g. TNBC, CRPC, HGSOC and tumours with~     somatic mutations or other aberrations known to result in a hyperactivated PI3K-AKT pathway).~   "
93857|NCT02338609|"~     The primary objective of CRAD001M2305 is to report the long-term effects of everolimus~     treatment on height, weight and sexual development (using Tanner Stages) in children and~     adolescents with Tuberous Sclerosis Complex (TSC)-associated with Subependymal Giant Cell~     Astrocytoma (SEGA). The study will monitor the growth and development of pediatric patients~     with TSC-associated SEGA, previously enrolled in CRAD001M2301 until they reach Tanner Stage~     V, or until age 16 for females or 17 for males whichever occurs first.~   "
93858|NCT02338596|"~     As clinical and radiographic performance of an ultra-short anatomic cementless stem have been~     investigated only two randomized controlled studies, well-designed trials should aim for a~     thorough comparison of the outcomes of ultra-short and conventional cementless stems. The~     purpose of this study was to compare the outcomes of ultra-short and conventional stems in~     the same young patients who underwent simultaneous bilateral sequential total hip~     arthroplasties.~   "
93859|NCT02338583|"~     This prospective, single-arm multi-center study will provide clinical data in an~     observational setting using the Echelon Flex™ 45 and 60 Powered ENDOPATH® Stapler~     Articulating Endoscopic Linear Cutters (study Endocutter). Individuals undergoing VATS~     lobectomy for suspected or confirmed Non Small Cell Lung Cancer (NSCLC), or individuals~     undergoing VATS diagnostic wedge resection in accordance with their institution's Standard of~     care (SOC), and who meet study entry criteria, may be enrolled.~      Study procedures will include a wedge resection, wedge resection followed by lobectomy of the~     same lobe, or lobectomy.~   "
93868|NCT02338466|"~     Proximal Middle Cerebral Artery (MCA) occlusions constitute the most severe stroke.~     Intra-venous thrombolysis with rt-PA within the first 4,5 hours is the only proven effective~     treatment. Prognosis is closely related to the recanalization rate that reaches only 30 to~     50%. A new therapeutic strategy consisting in a sequential intravenous (IV) thrombolysis by~     rt-PA followed by 50UI/kg of IV tenecteplase (TNK) has been proposed in case of no~     recanalization after rt-PA. A case series of 13 consecutive patients treated by this~     association has been published in 2011. A high rate of recanalization without hemorrhagic~     transformation increase has been reported. However, efficiency and safety of this therapeutic~     have to be assessed in a randomized multi-centric study. Such a study is of great interest~     since interventional neuroradiology has not already shown superiority regarding IV rt-PA.~     Moreover interventional neuroradiologists specialists are only available in major hospital~     and an IV sequential strategy could provide an interesting alternative.~      Main study objectives:~      Main Clinical Objective:~      Sequential thrombolysis should be associated with a significant better outcome at 3-month,~     assessed by the modified Rankin score (mRS).~      Main Radiological Objective:~      Sequential thrombolysis should be associated with a higher rate of recanalization (TIMI 2b/3)~     at 24-hour.~   "
93869|NCT02338453|"~     This RCT examines the effectiveness of Attention Bias Modification Treatment (ABMT) as an~     augment to Cognitive-Behavioral Group Treatment (CBGT) for Social Anxiety Disorder (SAD) in~     adults. It is expected that ABMT vs. control training condition would achieve better~     therapeutic outcomes as indicated reduction in symptoms.~      Participants from three groups (estimated 40 patients) will be offered to participate in the~     study~   "
93870|NCT02338440|"~     Veno-occlusive disease (VOD) after hematopoietic stem cell transplantation (HSCT) remains the~     major complication. VOD occurs in 11-31% of pediatric HSCT and the mortality reaches up to~     50%.~      Prostaglandin E1 (PGE1) have been reported to prevent and relieve the severity of VOD by~     Gluckman et al.. Lipo-PGE1 is a transporter of PGE1, which is superior in concentrating PGE1~     and acts for prolonged time. Because of the prolonged effective time, lipo-PGE1 acts~     comparable effects by 1/4~1/8 of PGE1 dose. Empirically, pediatric HSCT centers adopt~     lipo-PGE1 in dose of 1 mcg/kg/day (0.042 mcg/kg/hr), which is 1/7 of the dose recommended by~     Gluckman, et al. This prospective study will investigate the concentration of lipo-PGE1 with~     preventive lipo-PGE1 with empirical dose (1 mcg/kg/day).~   "
93871|NCT02338427|"~     Amyloidosis is involved in many rare diseases in relation to the diversity of amyloid~     proteins involved in the formation of abnormal tissue deposits. There are approximately 30~     proteins involved in amylose's constitution. The therapeutic management varies depending on~     the type of amyloidosis observed.~      The application of conventional techniques immunolabeling of amylose does not allow the~     comprehensive characterization of amylose forms, due to failures of the technic, the false~     positivity of some results, or lack of frozen tissue available for typing light chain~     (lambda, kappa).~      In this study, the main objective is the comparison of two capacity of amylose~     characterisation: immunohistochemistry and proteomics analysis.~      The purpose of this study is to validate the superiority of proteomic analysis by~     demonstrating the improvement of the precision, the reduction of technical failure, as well~     as the correction of erroneous diagnosis, authorizing a more adapted therapeutic management.~   "
93872|NCT02338414|"~     The aim of this study is to evaluate the efficacy of romiplostim administered at every other~     week in ITP patients who attained stable platelet counts ≥ 50 x 109/L for 4 consecutive weeks~     after weekly doses of romiplostim.~   "
93873|NCT02338401|"~     Resting metabolic rate (RMR) declines by 1-2% per decade after 20 years of age. This~     reduction is linked to a decrease in fat free mass (FFM) (10-20%) and the rate of energy~     expenditure of tissues (Manini 2010).~      It has also been shown that as we age there is a:~        -  Concomitant reduction in basal fat and carbohydrate oxidation, most likely due to the~          decrease in RMR than to a change in respiratory exchange ratio (RER) (St-Onge and~          Gallagher 2010).~        -  A change towards a more saturated membrane of different tissues (Rabini et al 2002).~      Incorporation of omega-3s, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), into~     cell membranes may alter energy metabolism by:~        -  Increasing the rate at which proteins operate (Hulbert 2007).~        -  Promoting the release of EPA and DHA into the cytosol which will act as ligands for~          peroxisome proliferator-activated receptors (PPARs) (Calder 2011). PPARs play an~          important role in energy homeostasis by regulating genes involved in lipid metabolism~          (Kota et al 2005).~        -  Augmenting protein synthesis through activation of the mTOR-p70s6k pathway (Di Girolamo~          et al 2014).~      Supplementation with fish oil in older males and females:~        -  Increases whole muscle phospholipid profile of EPA and DHA (Smith et al 2011).~        -  Increases lean body mass (LBM), RMR, and fatty acid oxidation (Logan et al unpublished)~        -  Decreases carbohydrate oxidation (Logan et al unplubished). Skeletal muscle (SM)~          accounts for 20-30% of RMR (Zurlo et al 1990, Manini 2010), therefore it is tempting to~          speculate that these changes may occur by some of the mechanisms described earlier, with~          skeletal muscle being an important contributor.~      To date there are no studies that have examined the effect of n-3 supplementation (3g/day)*~     on plasma membrane fatty acid composition, RMR and substrate oxidation, and the possible~     mechanisms behind it.~      Therefore the purpose of this study is to determine whether in older adults (female and~     male), supplementation with n-3 alters:~        1. RMR and fatty acid oxidation.~        2. Membrane composition of whole muscle and sarcolemma.~        3. Content of skeletal muscle membrane fatty acid transport proteins.~        4. Dose response of NaKATPase and SERCA efficiency~        5. Content of mitochondrial proteins~        6. Expression and content of PPARs and proteins involved in translocation of FA~          transporters (AMPK, ERK1/2, CamKII).~        7. Phosphorylation of AMPKα(THR172), ERK1/2(THR202 TYR204) and CaMKII(THR286).~        8. Proteomic profile of skeletal muscle.~        9. Body composition~   "
93874|NCT02338388|"~     The aim of this trial is the surgical method in cesarean deliveries, especially the uterotomy~     closure technique.~   "
93875|NCT02338375|"~     The purpose of this study is to evaluate the safety and efficacy of adding allogenic~     umbilical cord blood-derived stem cell product(Cartistem®) on currently standard treatment of~     arthroscopic curettage and microfracture for osteochondral lesion of talus.~   "
93876|NCT02338362|"~     The purpose of this study is to determine whether a commonly prescribed orally inhaled~     corticosteroid treatment will induce a clinically meaningful elevation in intraocular~     pressure, when administered to patients with ocular hypertension (OHT) or open-angle glaucoma~     (OAG). Based on the response to high-dose corticosteroids, this patient group is more likely~     than the normal population to demonstrate this adverse effect.~   "
93877|NCT02338349|"~     The purpose of this study is to evaluate the safety, tolerability and preliminary efficacy of~     elacestrant (RAD1901) in patients with advanced ER+, HER2-negative breast cancer.~   "
93878|NCT02338336|"~     To evaluate drug safety and efficacy in patients treated with Nowarta110 and to determine~     therapeutic activity against Plantar Warts~        -  Clinical Tolerance~        -  Clinical Recovery~        -  Evaluate Safety~   "
93879|NCT02338323|"~     The purpose of this study is to determine whether febuxostat and benzbromarone could protect~     renal function, and which one could be better.~   "
93880|NCT02338310|"~     To determine whether perioperative endocrine therapy with an aromatase inhibitor (AI)~     followed by standard adjuvant therapy improves outcome compared with standard adjuvant~     therapy alone in postmenopausal women with hormone receptor positive breast cancer.~      To determine whether the proliferation marker Ki67 as measured by immunohistochemistry (IHC)~     in the excised cancer around 2 weeks after starting AI therapy will predict for time to~     recurrence (TTR) in the individual patient more effectively than the pre-treatment Ki67~     value.~      To determine whether molecular profiling 2 weeks after starting endocrine therapy predicts~     for long-term outcome in postmenopausal women with hormone receptor positive breast cancer~     better than at diagnosis.~   "
93881|NCT02338297|"~     Transcatheter arterial chemoembolization (TACE) is a key palliative treatment for patients~     with inoperable hepatocellular carcinoma (HCC). Arterioportal shunts (APS) can aggravate~     portal hypertension and the shunts let lipiodol flow to normal liver tissue and result in~     poor Lipiodol deposition in the tumor, causing liver ischemia.~      Occlusion of APS is a vital and initial step for the following embolization of tumor.~     Ethanol-gelfoam mixture(EGM) and gelfoam only both can occlude APS in patients with~     hepatocellular carcinoma (HCC).~      The aim of this study was to evaluate the efficacy and safety of EGM in treatment of APS in~     the procedure of TACE, and to analyze the prognostic factors for survival in this kind of~     patients.~   "
93882|NCT02338284|"~     Patients admitted to the ICU may have delayed awakening after their critical illness has~     resolved. Though most either are due to metabolic causes or delayed elimination of sedative~     medications, more serious pathologies such as intracranial hemorrhage, ischemic stroke, and~     vasogenic edema may also be the cause of coma. These pathologies all result in increases in~     intracranial pressure (ICP) with cerebral edema. Identifying elevated intracranial pressure~     elevations have so far, relied on invasive monitoring techniques requiring placement of an~     intracranial or intraventricular catheter.~      The optic nerve sheath diameter (ONSD) has been described as a highly sensitive (88-94%) and~     specific (85% - 94%) noninvasive technique of identifying increased intracranial pressures in~     patients with brain trauma, intracranial bleeding or stroke[1-4]. This method requires~     placement of an ultrasound probe on the patient's closed eyelid and then a direct measurement~     of the diameter of the optic nerve sheath at a pre-specified distance from the globe. A value~     greater than 58 mm has been shown to correlate significantly with an increased ICP (> 20 cm~     H20); r = 0.71, p<0.001 [5].~      The investigators hypothesize that bedside ultrasound measurement of the ONSD is a simple~     screening test for increased intracranial pressure and can be used to rapidly and efficiently~     identify patients in the ICU who have coma due to an increase in intracranial pressure. The~     investigators propose to carry out an observational trial to determine the predictive ability~     of the Optic Nerve Sheath Diameter for cerebral edema/ increased intracranial pressure and to~     compare it with the results of neuroimaging (CT and/or MRI).~   "
93883|NCT02338271|"~     1. Subject: 10 patients~           : Chronic low back pain patients with lumbar intervertebral disc degeneration~        2. Investigational Product~           : Autologous adipose derived mesenchymal stem cells plus hyaluronic acid derivatives~          (Tissuefill)~        3. Time frame~             -  1 year~   "
93884|NCT02338258|"~     The purpose of the study to supplied the diagnostic and treatment criteria of the nonunion of~     the long tubular bone after treatment of Intramedallery nailing~   "
93885|NCT02338245|"~     This is an open-label, randomized, parallel group Phase 2A/2B study to evaluate the clinical~     activity of ASLAN001 in combination with capecitabine compared with lapatinib in combination~     with capecitabine in patients with HER2 positive metastatic breast cancer that has failed on~     prior trastuzumab therapy.~   "
93886|NCT02338232|"~     This is single-center, open-label, prospective study of telmisartan for the prevention of~     acute GVHD in approximately 60 subjects undergoing allogeneic HCT for treatment of a~     hematologic malignancy.~   "
93887|NCT02338219|"~     The purpose of this study is t o evaluate levator ani morphology following normal vaginal~     delivery and cesarean section (elective and emergent), using three-dimensional (3D)~     ultrasound, and to study the effect of mode of delivery on female sexual function.~   "
93888|NCT02338206|"~     The long down regulation protocol is widely used in the in vitro fertilization cycles, now it~     will be assessed regarding its efficacy, in poor responder females undergoing in vitro~     fertilization cycles, alone and after the addition of growth hormone.~   "
93889|NCT02338193|"~     Women with a history of gestational diabetes (GDM) are at substantially increased risk of~     type 2 diabetes mellitus (T2DM). Compared with the general population, these women are more~     likely to be overweight or obese. Moreover, weight gain after GDM is significantly associated~     with T2DM, independent of baseline body weight. Weight gain, particularly increased central~     adiposity after delivery, is strongly associated with deterioration of β-cell compensation~     for insulin resistance. Taken together, our findings and other studies support increased~     abdominal fat as the strongest factor associated with declining B-cell compensation for~     insulin resistance in prior GDM women at high risk for T2DM. Dapagliflozin is a novel highly~     selective SGLT2 inhibitor that improves glycemic control by reducing renal glucose~     reabsorption leading to urinary glucose excretion. Its efficacy and safety has been studied~     in multiple randomized controlled trials including an add-on to metformin compared with a~     placebo. To the extent that glucotoxicity contributes to the demise in β-cell function in~     subjects with impaired glucose, SGLT2 inhibitors also may prove useful in the treatment of~     prediabetes. An additional secondary benefit of SGLT2 inhibition is the elimination of~     calories in the form of glucose. The loss of glucose with attendant caloric loss contributes~     to weight loss; in addition, improvements in β cell function have been seen. Weight loss seen~     with SGLT2 inhibitors is similar to that seen with glucagon-like peptide 1 analogs, and may~     be more acceptable because they are oral agents. A consistent finding in all dapagliflozin~     studies has been a reduction in blood pressure. The investigators hypothesize that~     combination dapagliflozin -metformin treatment over a 24-week period will have a greater~     positive impact on body weight, anthropometric measurements and glycemic and cardiometabolic~     parameters than dapagliflozin or metformin monotherapy in overweight/obese at-risk women with~     a history of GDM.~   "
93890|NCT02338180|"~     It is of clinical importance to arrest the development of approximal caries at an early~     stage. The potential for initial caries to develop into manifest lesions has motivated~     studies on the use of sealants to arrest the progression of caries on both occlusal and~     approximal tooth surfaces.~      Therefore, the aim of the present study was to follow-up and examine after 3.5 years, the~     efficacy of sealing caries-free or non-cavitated mesial surfaces of first permanent molars~     abutting lesions on the distal surfaces of second primary molars. The null hypothesis tested~     here was that preventive and therapeutic sealants do not prevent the development or slow the~     progression of dental caries over a period of 3.5 years in comparison to non-sealed control~     surfaces.~   "
93891|NCT02338167|"~     Among patients with breast cancer the subgroup of patients with metastases are considered the~     group of patients with the worst prognosis. Not only with regard to therapy decisions but~     also with regard to quality assured healthcare and health economics this entity of patients~     remains a challenge.~      Recently, novel advances in breast cancer therapy aim at the targeted therapy of tumor~     entities and identification of patients, for whom the greatest therapy benefit and the least~     side effects are expected.~      However molecular assessment of the patient and the tumor in the metastatic situation is not~     performed on a routine basis and in many cases tumor characteristics from the primary tumor~     are considered reliable enough to make therapy decisions for the metastatic patients.~     Although molecular reassessment of tumor characteristics from tumor material of the~     metastasis is recommended in national guidelines, only a minority of patients is biopsied,~     because of the invasiveness of the procedure, even though biopsy related complications are~     reported to be rare.~      With modern analytic methods from blood based biomaterial there seems to be an opportunity to~     correlate blood based tumor assessments with actual characteristics of the tumor. These~     include expression analysis, tumor mutation analysis, tumor gene copy number abberations and~     others. One of the main aims of the PRAEGNANT study is therefore to establish an~     infrastructure for the comprehensive analysis of tumor and metastatic molecular~     characteristics of the patient and the tumor.~      Furthermore the impact of health care related outcomes such as health economics novel~     approaches for integration of patients in study conduct and health care awareness are study~     aims of the PRAEGNANT study.~   "
93892|NCT02338154|"~     The purpose of this active post-market surveillance study is to confirm the safety and~     effectiveness of the EDWARDS INTUITY Valve System in the study population.~      The objective is to evaluate cardiac performance characteristics and adverse events rates~     associated with the EDWARDS INTUITY Valve in patients undergoing AVR. The AVR surgical~     approach is either full or partial sternotomy or a right anterior thoracotomy.~   "
93893|NCT02338141|"~     This study will evaluate the effectiveness of portable colposcopy when compared to~     conventional colposcopy (25x magnification of the cervix, the gold standard) and~     Visualization Inspection with Acetic acid (VIA, with 1x magnification, the accepted~     low-resource method). Half the participants will be evaluated for cervical pathology by~     portable colposcopy after VIA assessment, while the other half will be evaluated by~     conventional colposcopy. This study also will use collected lab specimens for human~     papillomavirus (HPV)-positive women to determine those HPV genotypes most prevalent among~     higher grade disease cases (CIN II+) and among the sub-group of human immunodeficiency virus~     (HIV)-positive women.~   "
93894|NCT02338128|"~     The purpose of this study is to determine whether Febuxostat could protect cardiovascular~     function of peritoneal dialysis patients by lowering serum uric acid.~   "
93895|NCT02338115|"~     The purpose of this prospective observational study is to understand the relationship between~     paclitaxel exposure and development of peripheral neuropathy during treatment.~   "
93896|NCT02338102|"~     The purpose of this study is to learn whether nasal saline irrigation is beneficial to~     patients undergoing radiation therapy for oropharyngeal cancer.~   "
93897|NCT02338089|"~     Postpartum hemorrhage (PPH) is a leading cause of maternal morbidity and mortality worldwide~     and is caused most commonly by poor uterine muscle (myometrium) tone after delivery. The~     first line agent used in the prevention and treatment of PPH is oxytocin.~      Women who require augmentation of labor with intravenous oxytocin because of inadequate labor~     progression have been shown to be at increased risk of PPH. Typically, for augmentation of~     labor, oxytocin is used as a continuous infusion, with no consensus on the initial dose, its~     increments or maximal limit. High concentration continuous oxytocin infusions are not without~     theirs risks, which include hyperstimulation, fetal distress, as well as uterine rupture.~      Studies have shown the clinical benefits of pulsatile oxytocin delivery for labor induction~     and augmentation with regards to requirement of less total oxytocin, similar uterine~     contractility and similar rates of caesarean delivery when used for labor induction and~     augmentation. However, the rate of PPH as a primary outcome measure has not been~     investigated. Therefore we currently do not know the effect of pulsatile oxytocin delivery on~     the rate of PPH.~      The investigators hypothesize that the effect of myometrial desensitization following~     pulsatile oxytocin exposure would be lower when compared to continuous oxytocin exposure.~     These results will help in establishing whether myometrial contractility and sensitivity to~     oxytocin can be better preserved by delivery of pulsatile oxytocin, rather than continuous~     oxytocin for labor induction and augmentation, and thereby result in less PPH.~   "
93898|NCT02338076|"~     Petrolatum is a very well-known emollient that has been used since the 1800's. Not only has~     it been used to help with dry skin, but it is also marketed as a substance that protects~     minor cuts and burns. In the past it was thought to be inferior to topical antibiotics in~     infection prevention for cutaneous wounds. However, in 1996 a large, multicenter trial~     including over 900 patients showed that petrolatum is as safe and effective as the topical~     antibiotic, bacitracin in preventing infections for patients undergoing dermatological~     surgery. In this trial, not only did the petrolatum group have similarly low rates of~     infection, this group also reported no cases of contact dermatitis. Aside from being more~     expensive than petrolatum, bacitracin and other topical antimicrobials (i.e. neomycin) have~     been known as common culprits of contact dermatitis. In a study done by the North American~     Contact Dermatitis Group between 2005-2006, 9.2 and 10% of the over 4,000 patients who were~     patch tested had an allergic reaction to either bacitracin or neomycin, respectively. For the~     above reasons, it is clear that petrolatum is an appealing alternative to topical antibiotics~     for infection prevention in patients undergoing dermatological procedures. This study however~     lacked any mechanistic analyses to provide molecular insight as to how petrolatum was~     effective at infection prevention.~      The aim of this research is to study the effect of petrolatum on innate immune reactions in~     the skin. In particular, petrolatum's effect on various antimicrobial peptides after contact~     with the skin for 3 days will be examined. This will be done through immunohistochemistry for~     various cellular infiltrates as well as mRNA gene expression via RT-PCR analysis for~     inflammatory and AMP genes. Tissue samples of petrolatum occluded skin will be compared to~     both healthy skin and skin under occlusion alone as controls. These comparisons will isolate~     the effect of the petrolatum on the skin.~   "
93899|NCT02338063|"~     The purpose of this study is to determine whether immersive virtual reality technology is an~     effective intervention tool for HIV Prevention with adolescents.~   "
93910|NCT02337920|"~     Despite effective femoral artery endarteriectomy, patients with occlusive arteritis may need~     complementary stenting of revascularization procedures within the 2 years after the primary~     surgery because of a poor blood supply in their lower limb extremity. The Near infrared~     spectrophotometry (NIRS) is a non-invasive monitoring of the brain or tissue oxygenation and~     provide information on the quality of the local oxygen supply. The aim of our observational~     study is to correlate the intraoperative NIRS variations at the calf and the soles and the~     one-year evolution of the arteritis.~   "
93900|NCT02338050|"~     This is a phase II, open-label, nonrandomized, prospective study to evaluate the activity,~     safety, and feasibility of administration of moxetumomab pasudotox in the pre-allogeneic~     hematopoietic cell transplantation (HCT) setting to patients with B-lineage Acute~     Lymphoblastic Leukemia (ALL) who are in a morphologic complete remission and have~     pre-transplant minimal residual disease (MRD) > 0.01% (detected by flow cytometry). The~     primary objective of this study is to determine if treatment with moxetumomab pasudotox in~     the MRD positive setting is able to lead to MRD negativity (< 0.01% by flow cytometry) or at~     least a 1-log10 reduction in MRD prior to allogeneic HCT.~   "
93901|NCT02338037|"~     This pilot trial studies the brain concentration of eribulin mesylate in treating patients~     with primary or metastatic brain tumors. Drugs used in chemotherapy, such as eribulin~     mesylate, work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Collecting small~     samples of brain fluids may help determine how well eribulin mesylate concentrates into the~     brain tumor.~   "
93902|NCT02338024|"~     This study proposes to assess whether a modified Antiretroviral Treatment Access Study~     intervention, proved to be effective in the U.S. and based on the nurse case management~     approach, can impact the enrollment in HIV care of recently detected HIV-positive patients in~     specialized health care clinics in three regions in Ukraine, using the existing local~     infrastructure. The proposed study addresses a significant public health issue of non-/late~     enrollment of HIV-positive persons in HIV care and treatment.~   "
93903|NCT02338011|"~     1. Compare the effect and safety of gefitinib alone with gefitinib plus concomitant~          WBRT(whole-brain radiotherapy ) in treatment of NSCLC patients harboring an EGFR~          mutation with multiple BM.~        2. Verify the failure pattern of NSCLC patients harboring an EGFR mutation with multiple~          BM.~        3. Explore the rescuable therapy after progression of disease.~   "
93904|NCT02337998|"~     Purpose: Quantify the relationship between brachial plexus deformations caused by backpack~     carriage and upper extremity performance.~      Significance of expected results:~      The study will allow to quantify the effect of load carriage on both neural and vascular~     function parameters.~      Study plan The effect of nerve strain on neural function: based on the strains obtained for~     each load from computational simulation, and from animal studies published in the literature,~     the expected neural function, (e.g., motor and sensory) dysfunction will be estimated.~      Following signing an informed consent form, 12 young adult subjects (18-35 years) will don a~     military backpack loaded with 25-40 kg. Each volunteer will undergo the following test at~     baseline, following 45 min exposure, and following 15 min of recovery:~        1. Index finger microvascular flow will be measured by photoplethysmography (PPG).~        2. Sensory measurement at the finger; Light touch threshold will be measured by mechanical~          stimulation that will be applied using Von Frey Filaments of the Semmes-Weinstein~          Monofilament (SWM) type.~        3. Forearm thermal sensation threshold; As a measure of sensory function in the forearm,~          cold and warm sensation thresholds will be measured with a computerized quantitative~          thermal sensory device.~           Immediately following the 45 min loading exposure, the fine motor function of the index~          finger will be tested by the following procedures (in an unloaded condition):~        4. Index finger motor function; Force application profile during a trigger press will be~          measured using a force sensor located on a trigger of a dummy weapon simulator. Force~          application rate, peak force, and press-to-press peak force variability will be measured~          based on 10 trigger presses.~        5. Accuracy of force application; Will be evaluated by the simulated shot accuracy,~          horizontal displacement (X) and vertical displacement (Y).~        6. Subjective parameters; in all time points, the volunteers will be asked to rate their~          level of pain sensation intensity (VAS sensory) and degree of unpleasantness (VAS~          affective) in the shoulders and other load bearing sites, as well as ratings of~          perceived exertion (RPE). All subjective parameters will be assessed using visual~          analogue scales.~   "
93905|NCT02337985|"~     This pilot clinical trial studies gene therapy following combination chemotherapy in treating~     patients with acquired immune deficiency syndrome (AIDS)-related non-Hodgkin lymphoma.~     Placing genes that have been shown in the laboratory to inhibit the growth and spread of the~     immunodeficiency virus (HIV) into the patient's peripheral blood stem cells may improve the~     body's ability to fight HIV. Drugs used in chemotherapy work in different ways to stop the~     growth of cancer cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Giving gene therapy after combination chemotherapy may improve~     the body's ability to fight HIV and AIDS-related non-Hodgkin lymphoma.~   "
93906|NCT02337972|"~     The aim of this study is to investigate the conjunctival bacterial flora and antibiotic~     resistance patterns following serial intravitreal injections of anti-VEGF in diabetic~     patients, using a povidone-iodine preparation without preinjection or postinjection topical~     antibiotics.~   "
93907|NCT02337959|"~     The purpose of this clinical study is to evaluate the imaging performance of the DRX Plus~     3543 and DRX Plus 3543C Detectors (flat panel digital imaging devices) as compared to the~     currently marketed Carestream DRX-1 Detector. The results of this study will be included in a~     Traditional 510(k) FDA Submission to obtain clearance to market the new detectors in the US.~     The study was designed in accordance with the FDA Guidance titled Guidance for the~     Submission of 510(k)'s for Solid State X-ray Imaging Devices, issued on August 6, 1999.~   "
93908|NCT02337946|"~     The purpose of this study is to exploratorily examine efficacy and safety in the patients~     with chemotherapy-naïve unresectable, advanced/recurrent colorectal carcinoma of KRAS~     wild-type who have been treated with 6 cycles (2 weeks/cycle) of first-line mFOLFOX6 +~     panitumumab combination therapy and then assigned to two groups i.e., a group receiving~     5-FU/LV + panitumumab combination therapy and a group receiving mFOLFOX6 + panitumumab~     combination therapy.~   "
93909|NCT02337933|"~     The metabolic syndrome is characterized by the presence of overweight/obesity, insulin~     resistance, hyperglycemia, dyslipidaemia and hypertension and an inflammatory state, which~     together increase the risk of developing cardiovascular disease (CVD) or diabetes mellitus~     type 2 (DM2). It is also characterized by a decreased insulin sensitivity, namely, lower~     ability of insulin to metabolize glucose, key in the physiopathogeny of disease process.~      In the search for a pharmacological agent that can attend more components of the metabolic~     syndrome and above all improve insulin sensitivity to effectively prevent the development of~     CVD and DM2, ursolic acid is a promising compound.~      Ursolic acid is a pentacyclic carboxylic acid present in medicinal herbs, parts of some~     fruits like apple peel, and plants such as rosemary. There is scientific evidence of~     important benefits of ursolic acid level in vitro and in vivo on insulin, metabolism of~     lipids and glucose, as well as on the body weight and metabolic parameters. However, the~     results are not clear and the mechanisms are not fully elucidados.~      The aim of this study is to evaluate the effect of ursolic acid on the insulin sensitivity~     and metabolic syndrome.~   "
93911|NCT02337907|"~     The study is designed to compare the effects of BI 409306 compared to placebo in patients~     with cognitive impairment due to Alzheimer's Disease~   "
93914|NCT02337868|"~     This trial will be a randomized, placebo controlled, double-blind (within dosing group), dose~     escalation phase 1 trial, evaluating dosages of 1 mcg and 4 mcg of HydroVax-001 WNV vaccine~     given intramuscularly on Day 1 and Day 29 in up to 50 healthy adults > /=18 and < 50 years of~     age. The primary objective is to assess the safety, reactogenicity, and tolerability of the~     HydroVax-001 WNV vaccine administered intramuscularly in a two-dose series on Days 1 and 29~     at a dose of 1 mcg or a dose of 4 mcg.~   "
93915|NCT02337855|"~     This is a Phase I, first-in-human study of a vaccine against S. mansoni infection.The study~     will recruit 72 healthy adult males and non-pregnant females from a single clinical center to~     test two formulations of Sm-TSP-2 vaccine (using the Alhydrogel® only, and using Alhydrogel®~     plus GLA-AF), each at 3 different doses: 10ug, 30ug, and 100ug. The primary objective is to~     assess the safety and reactogenicity of ascending doses of Sm-TSP-2/Alhydrogel® (10ug, 30ug,~     or 100ug) with or without GLA-AF vaccine given as three doses administered on Days 1, 57, and~     113.~   "
93916|NCT02337842|"~     This is phase I, double blind, placebo-controlled safety and infectivity study of~     experimental human Norovirus genogroup GII.4 administered to healthy adults 18-49 years of~     age. Subjects susceptible to the human norovirus GII.4 challenge strain. The challenge study~     will be conducted in 2-3 cohorts of approximately 20 subjects each.Subjects will remain in~     the inpatient facility for at least four days following challenge and assessed daily for~     clinical and virologic evidence of norovirus infection. The primary objectives are to~     evaluate the safety and reactogenicity of the norovirus GII.4 (CIN-1; 031693) challenge stock~     and to determine a safe and optimal challenge dose of Norovirus GII.4 Challenge Stock~     norovirus to achieve illness in > /=50% of subjects. Illness is defined as: diarrhea (>3~     loose or liquid stools or >300 gm of loose or liquid stool /24h), and/or vomiting during the~     inpatient period, in a participant with evidence of infection.~   "
93917|NCT02337829|"~     This study is to determine the response to acalabrutinib in patients with chronic lymphocytic~     leukemia (CLL) or small lymphocytic lymphoma (SLL).~   "
93918|NCT02337816|"~     Endometriosis is one of the most common benign gynecological, affecting about 10% of~     premenopausal women. The pathophysiology of this disease is still not completely clear.~     Despite its prevalence, there is no blood test available for the diagnosis of endometriosis~     and the average delay time to diagnosis is 9.4 years.~      Metabolomics is a scientific discipline that studies changes in metabolites related to the~     pathophysiology of the disease.~      Aim of the study is to identify an alteration in the expression of the metabolites in women~     with endometriosis~   "
93919|NCT02337803|"~     The study will aim to determine the effectiveness of a strength training program using~     resistance bands to increase strength in adults ≥65 years old~   "
93920|NCT02337790|"~     This study is designed to validate the use of the CoVa Monitoring System in subjects with~     implanted devices.~   "
93921|NCT02337777|"~     The purpose of this study is to study the diagnostic efficiency of functional magnetic~     resonance imaging in Abdominal and Pelvic Diseases.~   "
93922|NCT02337764|"~     The purpose of this study is to evaluate long-term safety of TVP-1012 (1 mg/day) with~     levodopa in Japanese participants with Parkinson's disease.~   "
93923|NCT02337751|"~     The purpose of this study is to evaluate the long-term safety of TVP-1012 (1 mg/day) in~     Japanese participants with early Parkinson's disease.~   "
93924|NCT02337738|"~     The purpose of this study is to evaluate the efficacy and safety of TVP-1012 (0.5 mg or 1~     mg/day) as an add-on to levodopa in Japanese participants with Parkinson's disease with~     wearing-off phenomenon.~   "
93925|NCT02337725|"~     The purpose of this study is to evaluate the efficacy and safety of TVP-1012 (1 mg/day)~     administered to Japanese patients with early Parkinson's disease.~   "
93926|NCT02337712|"~     This Phase II randomized study is to determine whether once-daily simultaneous modulated~     accelerated thoracic radiotherapy (RT) resulted in better survival than twice-daily RT for~     patients with limited-stage small-cell lung cancer (LD-SCLC).~   "
93927|NCT02337699|"~     25-SMI-2014 is a post market observational, questionnaire based study to assess the~     effectiveness of the Axium neurostimulator as a treatment for chronic post surgical groin~     pain. Within is also a nested feasibility study to assess the clinical utility of a~     Quantitive Sensory Testing (QST) protocol in the management of the described study group.~   "
93928|NCT02337686|"~     The goal of this clinical research study is to learn if Keytruda (pembrolizumab) can help to~     control glioblastoma. The safety of this drug will also be studied.~      This is an investigational study. Pembrolizumab is FDA approved and commercially available~     for the treatment of some types of melanoma. Its use against brain tumors in this study is~     investigational. The study doctor can explain how the study drug is designed to work.~      Up to 20 participants will be enrolled in this study. All will take part at MD Anderson.~   "
93929|NCT02337673|"~     The purpose of this study is to determine whether Electrical Impedance Tomography can be used~     as sensitive and specific predictor in the detection of postoperative pulmonary complications~     (e.g. pneumonia, bronchitis, acute respiratory distress syndrome, pleural effusion,~     pneumothorax, pulmonary edema, atelectasis, pulmonary embolism, hypoxemia, hypercapnia,~     spasms and obstructions of the airway) in patients undergoing epigastric surgery.~   "
93930|NCT02337660|"~     The purpose of this study is to examine whether non-alcoholic fatty liver disease (NAFLD) is~     associated with hepatic glucagon resistance and hyperglucagonemia.~   "
93931|NCT02337647|"~     The purpose of the research study is to evaluate how well the Distortion Correction Data~     Collection (DCDC) App works. The DCDC App is an experimental software application that is~     being developed at the University of Nebraska Omaha. The DCDC app will map and draw the~     visual distortions of patients with Age-related Macular degeneration.~   "
93932|NCT02337634|"~     The goal of the proposed study is to evaluate the efficacy and safety of silymarin in~     individuals with gambling disorder. The hypothesis to be tested is that silymarin will be~     more effective and well tolerated in subjects with gambling disorder compared to placebo. The~     proposed study will provide needed data on the treatment of a disabling disorder that~     currently lacks a clearly effective treatment.~   "
94005|NCT02336685|"~     The purpose of this study is to demonstrate the efficacy, safety, and tolerability of~     fulranumab as adjunctive therapy compared with placebo in participants with chronic moderate~     to severe pain and functional impairment from knee or hip osteoarthritis that is not~     adequately controlled by current pain therapy.~   "
93933|NCT02337621|"~     Recovery following major surgical procedures can be influenced by both physical (optimization~     of cardiopulmonary function, pain control, activity) and psychological factors. Physical~     activity recommendations for post-operative patients is difficult, in part because little is~     known about the short- and long-term benefits of exercise and mobility on post-operative pain~     and return to normal functioning.~   "
93934|NCT02337608|"~     -  Approximately 60 patients suffering from moderate to severe ulcerative colitis will be~          evaluated for improvement of disease activity (efficacy) when taking GLPG1205 or~          matching placebo once daily for 12 weeks in addition to their stable background~          treatment.~        -  During the course of the study, patients will also be examined for any side effects that~          may occur (safety and tolerability), and the amount of GLPG1205 present in the blood~          (Pharmacokinetics) as well as the effects of GLPG1205 on disease- and mechanism of~          action-related parameters (Pharmacodynamics) in blood, stool and colonic biopsies will~          be determined.~   "
93935|NCT02337595|"~     The stud will evaluate whether infusions of CD45RA-depleted lymphocytes from the donor early~     post-transplant is a safe way to improve immunity to common infections in recipients of~     TCR-alpha/beta depleted hematopoietic stem cell grafts.~   "
93936|NCT02337582|"~     A cluster randomized controlled trial was performed in Bogotá, Colombia between 2007-2008 to~     evaluate the effects of an opportunistic (hospital-based) screening program (intervention)~     vs. usual care (control) in which 26 clinics were randomized to an intervention (N=13) or~     control arm (N=13). At intervention clinics general practitioners were instructed to perform~     clinical breast examination (CBE) on all women aged 50-69 years attending clinics for~     non-breast health related issues, and to refer them for mammographic screening. Physicians~     from control clinics were not specifically instructed to perform breast-screening or refer~     women for mammography, but could do so if they thought it appropriate ('usual care'). Women~     were followed for 2 years post-randomization.~   "
93937|NCT02337569|"~     The objective of this study is to evaluate efficacy and safety of NPC-02 in patients with~     Zinc Deficiency.~   "
93938|NCT02337556|"~     To compare the nutritional effect on blood glucose of two commercially available enteral~     diets in overweight or obese patients in the Intensive Care Unit.~   "
93939|NCT02337543|"~     This study is a double blind, placebo controlled, ascending single and multiple oral dose~     study conducted in two parts, aimed at determining the safety and tolerability of single and~     multiple oral doses of NEO6860 in healthy subjects.~      Key secondary objectives are: assessment of the pharmacokinetic profile, effect of food and~     gender.~      The analgesic effect of NEO6860 will be investigated using experimental capsaicin-evoked pain~     methods.~      Part A will comprise an ascending single dose, with 6 dose levels. Part B will comprise an~     ascending multiple dose, with 2 dose levels.~   "
93940|NCT02337530|"~     The purpose of this study is to find out what effects a new drug, selumetinib, has on lung~     cancer when receiving standard chemotherapy with pemetrexed and platinum-based chemotherapy.~   "
93941|NCT02337517|"~     This pilot clinical trial studies how well vismodegib works in treating patients with chronic~     graft-versus-host disease that did not respond to previous steroid treatment. Chronic~     graft-versus-host disease can cause a build-up of scar tissue under the skin and lead to~     symptoms such as sclerodermatous skin changes, dry mouth, dry eye, narrowing of the~     esophagus, or vaginal graft-versus-host disease. Vismodegib may work against the build-up of~     scar tissue and be a better treatment for chronic graft-versus-host disease caused by a~     hematopoietic stem cell transplant.~   "
93942|NCT02337504|"~     Tremendous efforts and resources have been expended by the global community to ensure that~     antiretroviral therapy (ART) is available and accessible to all that need it. Despite these,~     less than a half of Human Immunodeficiency Virus (HIV)-infected patients requiring ART in~     sub-Saharan Africa (SSA) are receiving it. Some of the most significant barriers to attaining~     universal access to ART in this region include large distances that patients have to travel~     to clinic, time spent in accessing care and a significant shortage of human resources. In~     order to address these challenges the World Health Organization (WHO) advocates alternative~     care models especially those that incorporate task-shifting to lower cadre health care~     workers and lay persons. Unfortunately, few such alternative care models have been identified~     and very little data exist on their long-term outcomes.~      With this project we will develop and assess an alternative care model that is established on~     the platform of a HIV-infected peer-group (ART Co-op) and facilitated by community health~     workers (CHW's). This model of care is intended to decentralize ART services and bring them~     closer to the patients. Specifically, we will:~        1. Develop an acceptable and sustainable model for extending HIV care and treatment into~          the community.~        2. Perform a pilot study comparing the outcomes of patients enrolled in the ART Co-ops~          program to those receiving standard of care.~        3. Determine the cost savings and cost effectiveness of ART Co-ops.~   "
93943|NCT02337491|"~     In this research study, the investigators are looking to determine the effectiveness of~     Pembrolizumab (MK-3475) when given with bevacizumab or when given alone for the treatment of~     recurrent glioblastoma multiforme (GBM). This study will also test the safety and~     tolerability of Pembrolizumab (MK-3475) when given alone or with bevacizumab.~   "
93944|NCT02337478|"~     This pilot phase II trial studies how well vincristine sulfate liposome works in treating~     patients with acute myeloid leukemia that has returned after a period of improvement or has~     not responded to previous treatment. Drugs used in chemotherapy, such as vincristine sulfate~     liposome, work in different ways to stop the growth of cancer cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Liposomal~     encapsulation prolongs bioavailability (proportion of drug that enters the circulation when~     introduced into the body) of vincristine sulfate, and may increase its delivery to cancer~     cells with fewer side effects.~   "
93945|NCT02337465|"~     This clinical trial studies if kilo-voltage cone beam computed tomography (KV-CBCT) and~     ultrasound imaging works in guiding radiation therapy in patients with prostate, liver, or~     pancreatic cancer. Computer systems, such as KV-CBCT and ultrasound imaging, allow doctors to~     create a 3-dimensional picture of the tumor may help in planning radiation therapy and may~     result in more tumor cells being killed.~   "
93946|NCT02337452|"~     Objectives:~      To develop a secure, web-based program for family outreach in Clinical Cancer Genetics (CCG).~      The long-term goals of this program are expected to include, but are not limited to the~     following:~        1. To enable families with inherited cancer susceptibility and/or at increased familial~          risk of cancer to provide personal and family history of neoplasia through a convenient~          and self-directed program.~        2. To enable communication of possible inherited cancer susceptibility with and among~          family members through the web-based portal.~        3. To facilitate genetic testing, screening and prevention strategies in those at risk.~        4. Establish high-risk cohort for optional participation in research and clinical trials.~   "
93947|NCT02337439|"~     In this study, participants with schizophrenia and schizoaffective are given computer~     exercises to complete. The goals of the study are to determine whether: 1) any of the~     computer exercises can improve information processing problems in schizophrenia, 2)~     improvements in information processing are related to other cognitive improvements, and 3)~     there are changes in brain activity associated with using the computer exercises.~      The study will involve clinical interviews, cognitive tests, and frequent computerized~     cognitive training over the course of 2 months. Some participants will also have~     electroencephalography, a non-invasive test that measures brain activity, to determine~     whether there are changes in brain activity with the computer training.~   "
93948|NCT02337426|"~     This phase 1 trial studies the side effects and best dose of dimethyl fumarate when given~     together with temozolomide and radiation therapy(RT) in treating patients with newly~     diagnosed glioblastoma multiforme (GBM). Dimethyl fumarate may help radiation therapy work~     better by making tumor cells more sensitive to the radiation therapy. Drugs used in~     chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.~     Giving dimethyl fumarate with temozolomide and radiation therapy may work better in treating~     glioblastoma multiforme.~   "
93949|NCT02337413|"~     Constipation treatment has been found to ameliorate symptoms in some patients with nocturnal~     enuresis (bed wetting at night). This study aims to explore if treatment of patients without~     overt constipation (As defined by the ROME III criteria) will also respond to stool softening~     and GI behavioral therapy with reduction of their urinary tract symptoms when added to~     standard urotherapy.~   "
93950|NCT02337400|"~     The aim of this study is to evaluate a new cognitive behavioral smoking reduction program for~     ambulant patients in a three-armed study design. Study participants will be randomized to one~     of the following three study groups: experimental group: 5-week lasting cognitive behavioral~     reduction program (smoke_less); active comparator: 15 minutes counseling interview; waiting~     group: no intervention.~      The three follow-up measures take place after the reduction program in week 6, 17 an 29.~     After the finalisation of the last follow-up, participants from the active comparator and~     waiting group get the chance to take part at the smoking reduction program at no charge.~   "
93951|NCT02337387|"~     The purpose of this study is to evaluate the tolerability of two different formulations of~     blosozumab in women who have reached menopause.~      This study will last approximately 12 weeks for each participant, not including screening.~     Screening is required within 28 days prior to starting the study.~   "
93952|NCT02337374|"~     Purpose The aim of this study is to investigate the contribution of preoperative urodynamics~     to mid-urethral slings (MUS) success for developing an algorithm that uses conventional and~     easily accessible tools Methods Women with stress urinary incontinence and who desired~     surgical correction of their incontinence were included in the study. The selection of the~     procedure was according to an algorithm used in an institution developed by a chief of~     urogynecology department who had 25 years of urogynecology experience. Urodynamic and~     baseline factors that may be associated with surgery failure were analyzed in MUS failure.~   "
93953|NCT02337361|"~     An innovative, self-administered computerized screening and brief intervention (SBI) for~     drinking during pregnancy will be adapted for use with non-pregnant childbearing age women~     and its efficacy will be tested in a small trial. Study findings will inform a larger~     randomized control trial for a primary prevention tool with the potential for broad health~     impact.~   "
93954|NCT02337348|"~     Coronary artery intervention with stents is a routine procedure with several clinical~     indications. A stentfailure, ie stentrestenosis and/or stentthrombosis will occur in some~     patients. Several different mechanisms have been suggested. Stentfailure may be caused by~     mechanical properties of the stent. This may be secondary to suboptimal stentimplantation, ie~     over/undersizing or acquired ie malapposition or stentfracture. These stentproperties may be~     difficult to identify with conventional coronary angiography due to low image resolution. The~     hypothesis of the study is that high resolution imaging with optical coherence tomography~     (oct) will improve diagnosis and enable a more specific or tailored treatment with a~     subsequent reduction in later stentfailure.~   "
93955|NCT02337335|"~     Assesment of a predictive model of anemia management: Dosage of erythropoietin (EPO) and Iron~     adminsitration in hemodialysis patients.~   "
93956|NCT02337322|"~     There are few randomized clinical trials in advanced HIV patients. This is a multicenter,~     randomized, open clinical trial, comparing 2 parallel groups, to compare the immunological~     reconstitution and the virological efficacy and safety of 2 different combinations of~     antiretroviral therapy given once a day (QD): abacavir plus lamivudine plus either~     dolutegravir, or darunavir-ritonavir during 96 weeks in advanced antiretroviral naïve HIV-1~     infected patients with less than 100 CD4+ T-cells/mm3. Primary endpoint is the median~     increase in CD4+ T-cell count at 48 weeks after starting HAART.~   "
93957|NCT02337309|"~     SF1126 is a novel inhibitor of PI3 kinase and mTOR that includes an active moiety (consisting~     of LY294002) linked to an RGDS tetrapeptide that targets the active agent to integrin~     expressing tissues. In this first pediatric phase 1 trial of SF1126, dose escalation will~     follow a 3+3 dose escalation design. Once a recommended phase 2 pediatric dose is identified,~     an expansion cohort of 10 patients with tumors with MYCN amplification, Mycn expression, or~     Myc expression will be treated.~      Funding Source - FDA OOPD~   "
94734|NCT02327156|"~     The investigator evaluated the motor and sensory block durations and the postoperative~     analgesic effects of adding dexmedetomidine to levobupivacaine for sub-Tenon's anesthesia in~     patients undergoing vitreoretinal surgery. Motor and sensory block durations were considered~     as a primary endpoint.~   "
93958|NCT02337296|"~     This study includes a novel intervention entitled ADHERE, which includes one~     semi-structured 30-minute face-to-face session and three 10-minute weekly phone sessions over~     4 weeks, administered by an advanced practice nurse (APRN) to promote management of symptoms~     and adherence in patients prescribed oral anti-cancer agents. Innovations in cancer treatment~     are changing the treatment delivery landscape. It is projected that by 2015, 25% of treatment~     will be delivered in pill form. This shift in the treatment paradigm places greater~     responsibility on patients. However, patients with cancer are known to miss as much as~     one-third of the prescribed doses of oral agents required for treatment of their disease.~     Barriers to oral agent adherence include symptom severity, low self-efficacy, depressive~     symptoms, lack of motivation, or beliefs that the medicine will not help, age, and regimen~     complexity. The therapeutic outcome for those taking oral agents depends heavily on the~     ability of patients to adhere to the prescribed regimen. Thus, a critical need exists to test~     interventions that promote adherence and symptom management in patients taking oral agents.~      ADHERE provides systematic patient education (PE) with the investigators evidence-based~     Medication Management and Symptom Management Toolkit (Toolkit). This is combined with brief~     cognitive behavioral therapy (CBT) to focus thoughts and beliefs to influence action; and~     motivational interviewing (MI) to elicit reasons from patients to take action. The National~     Cancer Institute (NCI), American Society of Clinical Oncology (ASCO), and Oncology Nursing~     Society (ONS) have made adherence to oral agents a priority. Thus, the investigators are~     testing ADHERE's impact on symptom severity and adherence to the oral agent regimen and~     determining the acceptability and feasibility of the intervention among patients with cancer.~   "
93959|NCT02337283|"~     The aim of the study is to investigate the safety, tolerability, and pharmacokinetics of~     multiple rising doses of BI 425809 tablets given orally once daily for 12 days to young and~     elderly healthy male and female volunteers and to compare single dose pharmacokinetics of BI~     425809 given in the morning and in the evening.~   "
93960|NCT02337270|"~     This is a phase 1 study, in healthy volunteers who have previously been immunized with~     bacilli Calmette Guerin (BCG), to evaluate the safety and immune responses that develop in~     the blood and lungs following the administration by aerosol of a new experimental~     adenovirus-based vaccine for tuberculosis (TB), Ad5Ag85A.~   "
93961|NCT02337257|"~     Poor vitamin D status is very common in African Americans. Periodontitis (gum disease) are~     shown to be related to theincreased risk of cardiometabolic diseases. Vitamin D is freely~     available and cheap supplement that has shown beneficialeffect in the immune system~     regulation and maintenance of the cardiovascular health. In this study The investigators~     hypothesize thatvitamin D supplementation for 16 weeks in African Americans with~     periodontitis will result in clinical improvement in theirgum health as well as their~     cardiometabolic risk profile~   "
93962|NCT02337244|"~     The primary objective of this study is to obtain implant survivorship and clinical outcomes~     data for commercially available Persona knee implants used in primary total knee~     arthroplasty. The assessment will include:~        1. Implant survivorship based on removal of a study device.~        2. Safety based on incidence and frequency of adverse events.~        3. Clinical performance measured by overall pain and function, quality of life data,~          radiographic parameters and survivorship.~   "
93963|NCT02337231|"~     A randomized, controlled, cross-over clinical trial of borage oil vs soybean oil to determine~     whether the metabolism and/or impact of medium chain-polyunsaturated fatty acids (MC-PUFAs)~     in botanical oil supplements are changed in relationship to specific genotypes in a SNP~     (rs174537) strongly associated with FADS1 activity and PUFA metabolism.~   "
93964|NCT02337218|"~     This is a double‐blind randomized clinical trial. Both patients and the podiatrist that will~     evaluate and monitor study patients will be blinded to electrical stimulation application.~     The manufacturer of the units will be asked to not inform which patient received which unit.~     Each unit will be coded with a unique identification number, and the manufacturer units~     revealed their status, placebo or electric stimulation, only at the end of data collection~     for the last patient. Subsequently, the investigators could match the status of the~     identification numbers with the corresponding units to start analyzing the data. Patients~     that receive an activated electrical stimulation unit will receive a standard dose of 50~     volts as described above.~      The investigator will enroll a cohort of 80 diabetes (type II) patients with peripheral~     neuropathy (see section 6 for sample size justification). The diagnosis of diabetes mellitus~     will be based on World Health Organization criteria.(World‐Health‐Organization 1999). The~     inclusion and exclusion criteria are described in table III. The clinical assessments are~     described in table IV. The investigator will discuss the study design, duration, and its~     risks with potential subjects asked to participate. The participant will be provided with a~     consent form to read at their leisure. The investigator will be available to answer questions~     or provide more explanation as requested by potential participants and their family.~   "
93965|NCT02337205|"~     This is a phase 1 study to access the safety and tolerability of KX2-391 ointment in subjects~     who have Actinic Keratosis. This study will also access the amount of KX2-391 drug that~     enters the blood stream through dermal application of the ointment.~   "
93966|NCT02337192|"~     We demonstrated the use of the Antimicrobial Photodynamic Therapy as a coadjutant oral~     decontamination agent. It was also shown that SDS surfactant improves the antibacterial~     action of APDT when using Curcumin as the photosensitizer. The decontamination levels~     obtained with APDT are comparable with the levels observed with the use of Chlorhexidine. The~     clinical relevancy is the control of oral microbial load which will improve the patients'~     quality of life and will decrease the possibility of cross contamination in the dental~     office.~   "
93967|NCT02337179|"~     The purpose of this study is to determine the feasibility of introducing voluntary medical~     male circumcision as a form of HIV prevention in high HIV prevalence areas in the Dominican~     Republic.~   "
93968|NCT02337166|"~     BACKGROUND: Periodontal disease is an infection that results in progressive loss of dental~     support, which may lead to tooth loss.. The goal of the present study was to evaluate if~     recombinant human Fibroblast Growth Factor type 2 (rhFGF-2) applied in periodontal intrabony~     defects in a hyaluronic acid (HA) carrier would enhance the clinical paramenters of~     regeneration of the periodontal attachment apparatus and the long-term maintenance of the~     results obtained. METHODS: Thirty adult patients were evaluated. Initial treatment consisted~     in plaque control measures executed previously to the experimental phase. Two intra-bony~     defects in each patient were ramdomly allocated for each of the treatment methods employed.~     Control group (n=30) were treated by open debridement with the papilla preservation flaps,~     while the text group (n=30) also received a topical application of rhFGF-2/HA in the~     intrabony defect. The parameters evaluated were, probing depth (PD), gingival recession~     (REC), probing attachment level (PAL) and probing bone level (PBL). Clinical measurements~     obtained at baseline and 1, 5 and 10 years after the surgical procedure were compared.~   "
93970|NCT02337140|"~     Since 2002, transcatheter aortic valve implantation (TAVI) has resulted in a dramatic change~     in the prognosis of patients with aortic valve stenosis illegible to surgery. However, this~     intervention may induce heavy conduction disorder due to the proximity of the aortic annulus~     and the conduction pathways. So far, there is no clear recommandation for clinical management~     of conduction disorder after TAVI. Standard criterion cannot be applied due to the multiple~     comorbidity factors observed in these patients. As described in conventional aortic valve~     surgery, a degree of inflammation and ischemia of the conduction pathways may be involved in~     the first days. This is the reason underlying the systematic implantation of epicardial~     electrodes. Such temporary back-up pacing is not possible in TAVI patients.~      The primary end-point of this study is to confirm that standard criterion for pacing are~     reliable in post-TAVI conduction disorders and to analyze the contribution of a systematic~     electrophysiological study (EPS).~      In TAVI patients, indications for pacing were persistent high-degree atrioventricular block~     (AVB) or bundle branch block appearance associated to HV interval longer than 70ms, 24 hours~     after the procedure.~      After a two-month follow-up, clinical and ECG evaluation and 24-hour holter monitoring will~     be realized in patients without pacemaker and compared to data obtained from the devices in~     pacemaker-implanted patients (% of ventricular pacing > 1% ; presence of more than 1 AVB~     episod).~   "
93971|NCT02337127|"~     Current treatment guidelines indicate that oral antiviral agents for HBeAg-positive chronic~     hepatitis B virus infection (CHB) can be stopped if the patient has undergone HBeAg~     seroconversion with HBV-DNA loss measured at two consecutive occasions at least 6 months~     apart (primary treatment endpoint). Stopping treatment can be considered if undetectable~     HBV-DNA has been documented on three separate occasions 6 months apart in HBeAg-negative~     patients. However, oral antiviral drugs currently approved for the treatment of CHB have~     relatively limited sustained long-term efficacy and a large proportion of patients will~     suffer from HBV recurrence after stopping treatment.~   "
93972|NCT02337114|"~     Is Acceptance and Commitment Therapy (ACT) feasible and acceptable for adults with severe~     Traumatic Brain Injury (sTBI) in inpatient services? sTBI is associated with depression,~     anxiety and low self awareness. A key factor in recovery is adjustment to the effects of~     injury. Psychological intervention may facilitate this change; however what works is unclear.~     ACT seeks to improve psychological flexibility; the ability to be present with difficult~     thoughts and emotions, rather than fighting them, and to accept ourselves as we are, not what~     we believe we should be. Current research is limited, but what is published suggests it may~     be useful for this group.~      Due to the limited research this pilot study aims to conduct preliminary analysis on the~     acceptability and feasibility of ACT for people with sTBI whilst also examining the~     suitability of the study protocol in order to make recommendations for future studies.~     Clients and staff from three Brain Injury Rehabilitation Trust (BIRT) centres will be~     recruited, one of which will serve as the intervention centre.~      Clients in the intervention group will be asked to complete questionnaires a week before and~     after participation in the 6 week ACT programme. Clients in the comparison group will be~     asked to complete questionnaires a week before and after receiving 6 weeks of treatment as~     usual (TAU). The treatment group will also receive TAU. All participants will be invited to~     participate in a focus group at the end of this 8 week period to discuss their involvement in~     the study.~      Staff will be asked to complete a parallel version of one of the client questionnaires within~     a similar timeframe. In addition staff at the intervention centre will be invited to attend a~     focus group and complete an additional questionnaire after the eight week period.~   "
93973|NCT02337101|"~     Background:~      Five - 15 % of patients with concussion continue to experience impairing physical, cognitive~     and emotional symptoms longer than 3 months post-injury. Currently, no standardised treatment~     is available for patients with persistent post-concussional symptoms (PCS) and systematic~     treatment studies remain limited.~      Aim:~        1. to develop an early intervention programme based on principles from~          cognitive-behavioural therapy and graded exercise for young patients with PCS lasting~          more than 3 months, and~        2. to evaluate the efficacy of this intervention on PCS in a randomised, controlled trial.~      Methods:~      Patients aged 15 - 30 years diagnosed with concussion at hospitals in Central Denmark Region~     will be screened for persistent symptoms two months post-injury. Those with impairing~     symptoms will be invited to participate in a randomised controlled trial comparing the early~     intervention programme with enhanced usual care. We expect to include 120 patients from~     2015-2016. Treatment will be interdisciplinary and will begin approximately 3 - 5 months~     after concussion. All patients will complete self-report measures at baseline and 3, 6 and 15~     months after randomisation. The primary outcome is severity of PCS.~   "
93974|NCT02337088|"~     The purpose of this study is to determine if there is a difference in neonatal outcomes with~     delayed umbilical cord clamping at 30 versus 60 seconds. Our primary outcome will be~     intraventricular hemorrhage (IVH) (bleeding in the brain) in these infants.~   "
93975|NCT02337075|"~     Being physically active is important for everyone's health, but it is often challenging for~     people to start and sustain an activity routine. The investigators will develop and pilot~     test the PATH (PAthway To Health) program with Indigenous communities served by the Kwakiutl~     District Council (KDC) Health on North Vancouver Island. The project idea was conceived~     through a partnership between the communities and University of British Columbia health~     researchers. The PATH program will include an education sessions on how to be active,~     physical activity coaching by community health workers, and the use of Fitbit Flex (a~     wearable activity tracker). The investigators will develop a culturally appropriate online~     application to pair with Fitbit, which will provide instant feedback to individuals about~     their activity level. 60 community members will be recruited to test the PATH program. Their~     physical activity level, health status and use of activity resources at KDC Health Centres~     will be assessed.~   "
93976|NCT02337062|"~     A comparison of the efficacy of APD421 and placebo when combined with a standard anti-emetic~     in the prevention of PONV in patients at high risk of Post-operative Nausea and Vomiting~     (PONV).~   "
94002|NCT02336724|"~     Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and~     Flt3. Phase I study has shown that the toxicity is manageable.~      The purpose of this study is to evaluate the efficacy and safety profile of Famitinib in~     patients with advanced or metastatic gastrointestinal stromal tumor who failed from imatinib~     therapy.~   "
93977|NCT02337049|"~     In order to assess surrogate markers of cardiovascular risk in subtypes of preeclampsia, we~     will conduct a 10-year follow-up study comparing 40 women with a history of early onset~     preeclampsia; 40 women with a history of late onset preeclampsia and 40 women with a history~     of normotensive pregnancies.~      Eligible participants delivered at the Department of Obstetrics at Randers Regional Hospital~     1998-2008.~      Early-onset preeclampsia is defined as preeclampsia that develops before 34 weeks of~     gestation, whereas late-onset preeclampsia develops at or after 34 weeks of gestation.~   "
93978|NCT02337036|"~     Tacrolimus is the cornerstone immunosuppressant in children with liver transplantation, its~     use is complicated by its narrow therapeutic index and variable pharmacokinetics. This study~     is designed to assess the posology of tacrolimus in post-transplantation in the month after~     liver transplantation to obtain a therapeutic target between 10-15 ng/mL and the impact of~     biological and genetic factors on the pharmacokinetic parameters in paediatric liver~     transplant recipients.~   "
93979|NCT02337023|"~     The investigators perform neuropsychological tests and brain scintigraphy in 30 healthy~     subjects.~      These results will be compared with data obtained out of episode in patients with~     Kleine-Levin syndrome (KLS).~      The investigators want to determine if brain functional imaging and cognitive abnormalities~     persist during asymptomatic period in a large series of patients with KLS, and to find~     predictors of these abnormalities.~   "
93980|NCT02337010|"~     Patients who are scheduled for: elective oesophageal tumour resection, total gastrectomy,~     pancreas resection, major vascular, total cystectomy will be recruited.To investigate effects~     of central venous pressure (CVP) and central venous saturation (ScvO2) guided fluid~     management on intraoperative haemodynamic parameters, volume and vasopressor requirement, and~     postoperative organ function and postoperative inflammatory response.~   "
93981|NCT02336997|"~     The purpose of this study is to evaluating whether autologous grafted fat transplantation or~     SVF transplantation is safe and/or effective to accelerating skin regeneration and soft~     tissue expansion.~   "
93982|NCT02336984|"~     The purpose of the study is to treat patients with Ductal carcinoma in situ (DCIS) with a~     combined treatment of DC1 vaccine with Trastuzumab. In this study the investigators will~     assess the safety and immunogenicity of the combination therapy. The target population is~     women over 18 years of age and have a diagnosis of DCIS that express HER-2 3 positive.~     Participants will receive 6 vaccines along with 2 doses of trastuzumab.~      This study began at the Abramson Cancer Center of the University of Pennsylvania and will~     continue at H. Lee Moffitt Cancer Center and Research Institute.~   "
93983|NCT02336971|"~     This study seeks to enroll 76 couples in which one of the members is a combat-veteran with~     PTSD. Each couple will be randomized into one of two cognitive-behavioral therapies developed~     specifically as a treatment for PTSD—either Prolonged Exposure (PE) [1-4] or~     Cognitive-Behavioral Couples Therapy (CBCT) [5-7]. Whereas, PE was developed as a one-on-one~     therapy that focuses on treating the individual, CBCT for PTSD incorporates the partners into~     therapy and seeks to directly address relationship functioning while treating the PTSD~     symptomatology. Both partners in each couple will complete a battery of several assessments~     measuring various aspects of psychological distress (e.g., depression, PTSD) and relationship~     functioning at five time-points throughout the study. But, only the partners assigned to the~     CBCT group will be involved in the actual therapy sessions. Analysis will be carried out to~     identify whether any significant differences exist between PE and CBCT in treating PTSD and~     improving relationship functioning.~   "
93984|NCT02336958|"~     For ultrasound guided intermediate cervical plexus block this randomized comparison is~     testing the hypothesis, that an additional perivascular infiltration is associated with~     increased block quality.~   "
93985|NCT02336945|"~     This is a multi-center, prospective, non-pivotal, single arm, non-significant risk evaluation~     the Abbott Sensor Based Glucose Monitoring System - Pro across different stages of T2~     diabetes management. This is a non-significant risk study.~   "
93986|NCT02336932|"~     The purpose of this study is to describe changes in vitamin D parameters before, during and~     after a well-defined elective surgical trauma (knee arthroplasty) and to compare these~     changes to other steroid hormones (testosterone and oestrogens). The hypothesis is that~     profound changes in free and total vitamin D will occur as a result of changes between~     intravascular vs extravascular protein compartments during surgical trauma.~   "
93987|NCT02336919|"~     Participants will be recruited during their hospitalization for either heart attack or~     unstable angina and will be randomly assigned to either a text message program (Txt2Prevent)~     or usual care. They will be texted for the first 60-days after discharge. Texts will include~     topics regarding self-management and discharge protocols such as reminders to make an~     appointment with their general practitioner or to refill medication prescriptions. After 60~     days, the two groups will be compared for hospital readmission rates, quality of life,~     medication adherence, and self-management.~   "
93988|NCT02336906|"~     Constipation treatment has been found to ameliorate symptoms in some patients with lower~     urinary tract dysfunction (including day time or combined day time/night time urinary~     incontinence). This study aims to explore if treatment of patients without overt constipation~     (As defined by the ROME III criteria) will also respond to anti-constipation treatment with~     reduction of their urinary tract symptoms. Assessment of severity and response of lower~     urinary tract dysfunction will be based on the Vancouver NULTD/DES questionnaire.~   "
93989|NCT02336893|"~     The purpose of this study is to assess whether a formal training strategy using an interview~     PACIENTE may improve physician's skills and quality of communication with family members at~     the ICU.~   "
93990|NCT02336880|"~     This pilot randomized controlled trial (RCT) aims to test the feasibility and effectiveness~     of a guided internet-delivered cognitive behavioural therapy intervention in the treatment of~     cardiac anxiety and fear of body sensations in patients with non-cardiac chest pain. The~     control group will receive care-as-usual.~   "
93991|NCT02336867|"~     Anal fistulas are the main etiology of perianal abscesses and suppurations. They are common~     and generally associated with pain, anal incontinence, impaired quality of life and work~     incapacity. The therapeutic management of this disease has a double objective: heal the~     suppuration and preserve the sphincter function. Each year, anal fistulas affect 1 in 10 000~     in the normal population, with a difference in prevalence between men and women (1.23 per 10~     000 men and 0.56 per 10 000 women). The average age of the patients was 40 years (Simpson et~     al., 2012).~      In about 80% of cases, anal fistulas are secondary to an infection of Hermann and Desfosses'~     anal glands (cryptogenic or cryptoglandular). Infection of the anal gland can result in an~     abscess between the internal and external sphincters, which in turn can spread to other parts~     of the perianal region. The infection can follow many directions from this point in the~     intersphincteric plan. When the pus reaches the skin, the fistula is formed. Anal fistula~     therefore has always an intraductal origin, cryptic, with a primary port at this level, and~     the disregard of which causes the recurrence of the fistula; and usually a secondary port in~     the skin.~      Fistulas are usually divided into two groups. The first group contains fistulas called~     simple, which are intersphincteric fistulas or trans-sphincteric involving only the lower~     third of the sphincter complex. Fistulas usually didn't affect any muscle. The second group~     contains fistulas called complex. These are intersphincteric, trans-sphincteric, or even~     suprasphincteric, extrasphincteric fistulas.~      For many years, the treatment of choice was to open the fistula (fistulotomy), but this~     procedure was associated with a risk of incontinence, the consequences could be potentially~     devastating. Other surgical treatments include setons, fibrin glue, collagen plugs and~     advancement flap technique to cover internal opening of the fistula. The success of these~     therapies remains variable.~      The advancement flap technique remains a strategy of choice in the treatment of anal fistulas~     and particularly in the case of complex fistulas. The success rate of the advancement flap~     technique remains variable across studies but a recent meta-analysis finds a success rate of~     around 60%.~      A new technique for closing anal fistula is currently in development with the use of a~     closure clip nitinol (OTSC® Proctology Laboratory: OVESCO and French Distributor: Life~     Partners). This new technique has been validated in a porcine model of anal fistula, ensuring~     the safety of the device. A first case was published in a patient with complex anal fistula~     (high trans-sphincteric). After erosion fistula tract with a special brush, a nitinol clip~     (OTSC® Proctology) was deposited on the internal opening of the fistula. Eight months after~     surgery, the fistula was healed and the clip was removed by cutting with special pliers. This~     technique is currently being broadcast and dozens of patients were treated with this clip~     without any further scientific validation of the process.~      To date, this innovative technique of the closure clip has not yet been assessed in a~     randomized controlled trial. It is therefore essential to carry out a prospective evaluation~     in order to determine the effectiveness and safety of this new device in the case of complex~     anal fistulas.~   "
93992|NCT02336854|"~     A randomized, open-label, two-way crossover study to assess the tolerability and~     pharmacokinetics of Tacrobell® Tab. and Prograf® Cap. after a single oral dose in healthy~     male volunteers.~   "
94003|NCT02336711|"~     Phase I study to assess the feasibility (i.e. early toxicity) of Molecular Imaging-based Dose~     Escalation in HPV Negative Patients With Locally Advanced SCC of the Oropharynx.~   "
93993|NCT02336841|"~     The aim of this study is to test a novel guided self-help intervention for patients with~     Anorexia Nervosa. The 6-week intervention includes the use of self-help materials (i.e. a~     workbook and short video-clips) and weekly guidance from a peer mentor (i.e. a person~     recovered from Anorexia Nervosa). Self-reports will be completed at baseline, end of 6 weeks,~     and 6- and 12 months follow-up. Participants interested in taking part will be randomly~     allocated to one of two groups.~   "
93994|NCT02336828|"~     This study is to validate the use of the modified early warning score (MEWS) in an adult~     oncology ward as a predictor of 7 day mortality or intensive care unit (ICU) admission. It is~     expected that either a MEWS score ≥4 or a change in score of ≥2 from the initial reading will~     be associated with an increased risk of death or ICU admission, and should be regarded as a~     MEWS Alarm. If MEWS is proof to be a reliable alternative tool, early diagnosis and~     aggressive management of life-threatening complications in oncology patients, results in~     dramatic improvements in overall survival rates.~      This is a prospective, single centre, observational, cohort study. Objective of this study is~     to investigate the ability of the Modified Early Warning Score (MEWS) to predict 7 day~     mortality in adult clinical oncology ward patients.~      The alternate hypothesis of this study is a significant difference in 7 day mortality between~     adult oncology ward patients with a MEWS Alarm and adult oncology ward patients without a~     MEWS alarm.~      The null hypothesis is a no significant difference in 7 day mortality between adult oncology~     ward patients with a MEWS Alarm and adult oncology ward patients without a MEWS alarm.~      The primary outcome measure in this study is the number of patients who die within 7 days of~     a MEWS Alarm (7 day mortality).~      The secondary outcome measure in this study is the number of patients admitted to ICU within~     7 days of a MEWS Alarm.~   "
93995|NCT02336815|"~     This is a Phase 2b, single-arm, open-label, multicenter study of selinexor 80 mg plus~     dexamethasone 20 mg (Sd) dosed twice weekly in four-week cycles, in patients with~     penta-refractory MM (Parts 1 and 2) or quad refractory MM (Part 1 only).~   "
93996|NCT02336802|"~     Anxiety disorders are characterized by exaggerated levels of fear that are not proportional~     to the actual level of threat. More specifically, anxiety patients have marked deficits in~     the downregulation of fear reactions during situations of objective safety. Pre-clinical~     research on Pavlovian fear conditioning and extinction has discovered that fear~     downregulation stems from areas in the prefrontal cortex (the ventro-medial prefrontal~     cortex, vmPFC) that recruit intercalated cells in the amygdala to inhibit its central~     nucleus, which is responsible for a variety of behavioral expressions of fear (Milad & Quirk,~     2012). Accordingly, functional magnetic resonance imaging studies (fMRI) revealed reduced~     vmPFC activity coupled with increased fear reactions during situations of objective safety in~     anxiety patients (Milad et al., 2009). Another core symptom of anxiety disorders, though much~     less investigated, is the excessive avoidance of situations that trigger the fears. These~     'safety behaviors' often interfere with daily life activities and valued goals in life, and~     they are thought to perpetuate the exaggerated levels of fear by precluding opportunities to~     learn that the feared situations are actually not dangerous. Surprisingly, experimental~     research on avoidance behaviors in anxiety patients is virtually non-existent. This~     experiment modifies the Pavlovian fear conditioning procedure to include avoidance, and~     explores the behavioral and neural processes of this type of fear regulation in anxiety~     patients (trans-diagnostically) and healthy individuals.~   "
93997|NCT02336789|"~     The investigators propose to transplant feces from thin, disease-free donors into obese~     patients undergoing colonoscopy for screening for colorectal carcinoma.~      The investigators will obtain feces from healthy donors with a BMI of between 21-24. The~     investigators will perform colonoscopy on healthy patients with a BMI of 30-40 kg/m2 who have~     a clear indication for a screening examination.~      All patients will undergo a screening colonoscopy and will be allocated to receive either 250~     ml of diluted fecal material prepared from a screened donor, or an equivalent volume of~     normal saline (sham transplantation).~      The patients will be reviewed at 1 3 6 and 12 months. At this time note will be made of their~     weight, BMI and waist circumference. In addition note will be made of their fasting glucose~     and lipid profile.~   "
93998|NCT02336776|"~     Chronic kidney disease is a renal injury and progressive and irreversible loss of kidney~     function and in its most advanced stage is called chronic renal failure.~      Although hemodialysis replace some kidney function, patients suffer some alterations~     characterized by uremic syndrome typically expressed by: motor neuropathy and/or autonomic~     neuropathy, cardiac or musculoskeletal myopathies, peripheral vascular changes, among others.~     Thereby, the the adoption of physical exercise should be encouraged. However, it is known~     that the ability to exercise the subject in hemodialysis is low and keeping in mind the~     weakness of the muscular system in these individuals, the aim of this study is to assess the~     effects of functional electrical stimulation (FES) on muscle architecture of patients with~     chronic kidney disease hemodialysis.~      For this the following assessments will be performed before and after stimulation:~     ultrasonography to assess muscle architecture; six-minute walk test to functional capacity;~     Kidney Disease and Quality of Life - Short Form questionnaire for quality of life; sit and~     stand test for resistance of the lower limbs; dynamometric by load cell for muscle strength~     of the lower limbs; flow-mediated dilatation to endothelial function; blood collection for~     analysis of inflammatory markers and DNA damage.~      The subjects will be randomized into two groups, FESG (functional electrical stimulation~     group) and CG (control group). The first will receive the FES in the quadriceps muscle of~     both thighs, for eight weeks, three times a week during hemodialysis session. While the~     control group only will be evaluated and re-evaluated.~      Expected results at the end of the protocol with FES are: increased quadriceps muscle~     thickness; longest distance covered on the six-minute walk test; improved quality of life;~     increase in resistance of the lower limbs; increased muscle strength of the lower limbs;~     improved endothelial function; improved inflammatory status and DNA damage.~   "
93999|NCT02336763|"~     This clinical trial studies giving radiation therapy to the liver in patients with uveal~     (eye) melanoma who have a specific chromosome loss (monosomy 3) or are DecisionDx Class 2 and~     therefore more likely to have their disease spread from the eye to the liver. Radiation~     therapy uses high energy x-rays to kill tumor cells and shrink tumors. Early radiation to the~     liver may reduce the development of tumors in the liver and the overall risk of disease~     recurrence.~   "
94000|NCT02336750|"~     Comparing Dexamethasone, Aprepitant and Mirtazapine With Dexamethasone and Aprepitant in~     Delayed Emesis Control and Appetite Improvement~   "
94001|NCT02336737|"~     The purpose of this pivotal study is to provide prospective evidence that the~     SentiMag®/SiennaXP® is safe and non-inferior to the current standard of care for lymph node~     localization in patients with breast cancer as part of a sentinel lymph node biopsy (SLNB)~     procedure and to summarize measures of product safety and performance.~   "
94006|NCT02336672|"~     In patients with locally advanced tumour, neoadjuvant treatment has been proposed in various~     modalities as a way to decrease size and downstage the tumour leading to a re-sectable~     disease. The HybridTherm probe (HTP), (ERBE Elektromedizin GmbH, Tübingen, Germany) com-bines~     bipolar RF-ablation with cryogenic induced cooling. It is well known that a bipolar~     radiofrequency system creates ablation with less collateral thermal damage than standard~     monopolar systems but with the trade-off to lose overall efficiency.~   "
94007|NCT02336659|"~     The aim of this study is to examine the effect of GLP-1 and other gut-secreted hormones~     (glucagon, GIP, grelin and PYY) on food-intake, appetite and glucose metabolism after~     Roux-en-Y gastric bypass surgery.~   "
94008|NCT02336646|"~     Bone marrow MSCs will be isolated from allogenic donors, expanded under hypoxic conditions~     using medium containing no serum or animal-derived reagents, and applies for Phase Ⅰ/Ⅱ study~     in treating 18 recipients with ischemic limb diseases.~   "
94009|NCT02336633|"~     The purpose of this study is to evaluate the therapeutic potential of Resveratrol on the~     caudate volume in HD patients, using volumetric MRI.~   "
94010|NCT02336620|"~     The Purpose of this study is to determine the impact of balanced salt solution versus~     chloride rich solution on clinical outcomes in paediatric severe sepsis or septic shock~   "
94011|NCT02336607|"~     The purpose of this study is to evaluate the effects on blood pressure control, pulse wave~     velocity, as well as safety and tolerability of felodipine single or combine with other drugs~     in Chinese Hypertension patients.~   "
94012|NCT02336594|"~     This is a Phase 1, randomized, open-label, 4-way crossover pharmacokinetic (PK) and~     pharmacodynamic (PD) study in healthy adult male subjects designed to assess the relative~     bioavailability of RDEA3170 2.5 mg tablets administered as a 10 mg dose (2.5 mg × 4 tablets)~     and of a single RDEA3170 10 mg tablet. This study will also assess the effect of a low-fat~     and high-fat meal on the PK and PD of RDEA3170 10 mg tablets.~   "
94013|NCT02336581|"~     To test the effectiveness of Acceptance and Commitment Therapy (ACT) versus enhanced~     Treatment as Usual (eTAU) delivered by hospital staff for inpatients with psychotic-spectrum~     disorders.~   "
94014|NCT02336568|"~     Oxytocin (OT) - a neurohormone and neuromodulator which is mainly synthesized in the~     hypothalamus - is a mediator stress regulation and improves social bonding. Recently, several~     theoretical studies suggested that PTSD patients have abnormal functioning of the OT system.~     According to these theories, dysfunction in the oxytocin system may modulate the~     interpersonal impairment that characterizes PTSD, and therefore intranasal OT may potentially~     relieve these symptoms. In two current studies that were conducted in Rambam health care we~     found that a single dose of intranasal OT reduces anxiety and irritability symptoms, and~     enhances emotional empathy and compassion, in patients with PTSD. The main goal of this study~     is to examine the effects of 21-days intranasal Oxytocin on clinical symptoms and social~     function in these patients.~   "
94015|NCT02336555|"~     This study aims to determine whether MK-8291 is effective in reducing pain in participants~     with post-herpetic neuralgia (PHN) with allodynia. The primary hypothesis is that when~     compared to placebo, treatment with MK-8291 reduces the change from baseline in~     participant-reported pain intensity by 1 on an 11-point numeric rating scale.~   "
94016|NCT02336542|"~     96 TB subjects and 96 non-TB subjects with lung disease who all meet the standard are divided~     into different groups through a randomized, blind methods.Every subject inject intradermally~     ESAT6-CFP10 and TB-PPD in different arms of the same person.Specific γ- IFN(gamma interferon)~     detection is needed before the injection.Evaluate the sensitivity (positive coincidence rate)~     ,the specificity (negative coincidence rate) and the coincidence rate of ESAT6-CFP10 in the~     tuberculosis patients and non-tuberculosis patients with lung diseases, and determine the~     optimal dose of ESAT6-CFP10 for clinical auxiliary diagnosis of tuberculosis.~   "
94017|NCT02336529|"~     Persistent pain after breast cancer surgery (PPBCS) affects 25-60% of breast cancer survivors~     and nerve damage has been implicated as the cause of this neuropathic pain condition. Local~     anaesthetic blockade of tenderpoints and the intercostobrachial nerve (ICBN) could provide~     clues to pathophysiological mechanisms as well as aiding diagnosis and treatment of PPBCS but~     has never been attempted. The aims of this study is to examine clinical effect of ultrasound~     guided blockades of the ICBN and tenderpoints of pain.~   "
94018|NCT02336516|"~     Post diarrheal hemolytic and uremic syndrome (D+HUS) is the first etiology of acute renal~     failure in children less than 5 years old in France. Previous works highlighted a mortality~     rate of 2 % and a prevalence of renal sequelae at one year after D+HUS onset in 25 % of~     patients D+HUS is a consequence of a gastrointestinal infection with shiga toxin (Stx)~     producing E.coli (STEC). The most frequent straight is E.coli O157H7. The sequence of STEC~     induced HUS is now well known. Typically, digestive symptoms appear five days following STEC~     ingestion. STEC colonize the intestinal mucosa, adhere to the enterocyte and cause a typical~     attaching/effacing lesion and inflammation. Then, diarrhea and vomiting occurred. D+HUS~     occurs in about 10% of patients and is a consequence of Stx systemic absorption. Indeed, Stx~     are released in the gastrointestinal tract, then after transferred to the systemic~     circulation. At the cellular level, Stx binds the globotriosylceramide (Gb3Cer) localized at~     the surface of the endothelial and epithelial cells of target organs. Following binding to~     Gb3Cer, the A subunits of Stx are internalized and trigger the activation of the apoptotic~     program leading to cell death. In addition, Stx are also able to enhance the production and~     the release of pro inflammatory factor (IL-1, TNFα, IL-6). Cytokines locally produced by~     Stx-stimulated cells can amplify the inflammatory processes and the prothrombotic state~     leading to the constitution of the microangiopathic lesions of HUS. To this day, management~     of D+HUS involves supportive care mainly based on fluid management, dialysis and red blood~     cells transfusions. Specific therapies used in D+HUS (plasma infusion, antithrombotic and~     anti inflammatory agents) failed to improve the course of D+HUS. The use of antibiotics~     remains not recommended while meta-analysis clearly showed that the use of bactericidal~     antibiotics could worse the course of D+HUS. In vitro experimentations highlighted that some~     classes of antibiotics like fluoroquinolones dramatically increase the production and the~     release of Stx before bacterial lysis and worsen the outcome of D+HUS in animal models. By~     contrast, azythromycin, a bacteriostatic antibiotic of the macrolides family blocking the~     protein synthesis in bacteria, has a strong inhibitory effect on Stx production and release~     by STEC as well as it inhibits the in vitro growth of STEC strains. In addition, azithromycin~     is able to inhibit the Stx-induced production of inflammatory cytokines which are considered~     to be essential for the development of D+HUS. Consistently the use of azithromycin in animal~     models of D+HUS dramatically improved the survival rate. Preliminary data on humans with~     D+HUS treated with azithromycin highlighted a lower prevalence of severe gastrointestinal~     involvement than in control patients. All these data supported the hypothesis that~     azithromycin should have a beneficial effect on D+HUS and should improve the short and long~     term outcome and deserves to be formally demonstrated in human with D+HUS.~   "
94019|NCT02336503|"~     To assess the safety and efficacy of 3 doses of BBI-4000 and vehicle (4 treatment arms), when~     applied once a day for 4 weeks, for the treatment of axillary hyperhidrosis.~   "
94020|NCT02336490|"~     This randomized pilot study proposes to field-test key logistical aspects of studying an~     intervention already available to patients on the pediatric ward, namely a discharge~     medication delivery service, called Meds-in-Hand, which has been refined via a quality~     improvement process, but not rigorously studied nor fully implemented.~   "
94021|NCT02336477|"~     Treatment strategies in non-dystrophic myotonias are based on selective case reports,~     clinical experience and theoretical benefit. Presently, the most promising antimyotonic~     medication is mexiletine (MEX) but its manufacturing was stopped. The proposed randomized,~     double-blind, placebo-controlled, crossover trial is designed to:~        1. study the safety and efficacy of mexiletine for the treatment of non-dystrophic~          myotonias~        2. validate electromyographic tests as a standardized outcome measure of myotonia~        3. assess the reliability and validity of a new clinical rating scale for myotonia~   "
94022|NCT02336464|"~     Although pain has been extensively studied in ICU patients, only a few studies have focused~     on dyspnea, which is experienced by 50% of mechanically ventilated patients. The purpose of~     the present study is to determine whether dyspnea in intensive care unit patients is~     associated with a higher length of stay in the ICU and a higher incidence of post traumatic~     stress disorders.~   "
94023|NCT02336451|"~     This is a phase II, multi-center, open-label, five-arm study in which the efficacy and safety~     of oral ceritinib treatment will be assessed in patients with NSCLC metastatic to the brain~     and/or to leptomeninges harboring a confirmed ALK rearrangement, using the FDA approved Vysis~     ALK Break Apart FISH Probe Kit (Abbott Molecular Inc.) test and scoring algorithm (including~     positivity criteria). If documentation of ALK rearrangement as described above is not locally~     available, a test to confirm ALK rearrangement must be performed by a Novartis designated~     central laboratory. Patients must wait for the central laboratory result of the ALK~     rearrangement status before initiating treatment with ceritinib.~   "
94024|NCT02336438|"~     One of the emerging complications of RNY gastric bypass surgery is mild to severe refractory/~     recurrent postprandial hypoglycemia. This complication can lead to a significant reduction in~     quality of life to severe disability. Unfortunately at this time there are no treatment~     guidelines or proven therapeutic options for the treatment of this complication. One of the~     proposed treatment options is the use of fiber supplements to help modify the absorption of~     glucose, slow the food bolus transit time more toward normal and restore the postprandial~     (after meal) glucose homeostasis. The investigators are proposing a pilot project for the use~     of Glucomannan soluble fiber as a treatment option for postprandial hypoglycemia in this~     cohort. This project will help the investigators to identify if Glucomannan soluble fiber can~     be used as an effective dietary supplement to eliminate or reduce this condition~   "
94025|NCT02336425|"~     This study planned to assess the effect on the reduction in rate of severe asthma~     exacerbations of different dose levels of QGE031 in asthma patients that are inadequately~     controlled with inhaled steroid plus beta-2 agonist medication with or without oral steroid.~     However, this study was terminated due to the efficacy results from an interim analysis (at~     the end of treatment epoch) of the Phase II study CQGE031B2201 (NCT01716754). Planned data~     analyses were not performed for this study due to the early termination and the very limited~     dataset (only 10 participants received study medication of the 440 participants planned).~   "
94026|NCT02336412|"~     Secondary preventative medications are prescribed to reduce the risk of recurrent stroke~     following ischaemic stroke. However, continuation rates can be as low as 50% and are likely~     to be multifactorial. One factor will be patients forgetting to take the medication or a~     reduced appreciation of the importance of the medication as the time from the stroke passes.~     Numerous approaches to improve persistence to secondary preventative medications have been~     tried. One simple approach is use of mobile phone text messages as a reminder for patients to~     take their medications. In this study, we will introduce an educational and motivational~     strategy to inform patients about their medications and explore whether a reminder~     intervention, using Short Message Service (SMS), improves adherence to antiplatelet drugs,~     antihypertensive medications and lipid lowering drugs. We will also explore whether this~     improves blood pressure and cholesterol levels in the first 3 months after stroke.~   "
94027|NCT02336399|"~     Chronic hepatitis B (CHB) is a serious liver disease worldwide, and the leading cause of~     cirrhosis and hepatocellular carcinoma (HCC).HBsAg loss/seroconversion is considered to be~     the ideal endpoint of antiviral therapy in both HBeAg-positive and HBeAg-negative patients,~     as well as the ultimate treatment goal in CHB. However, some patients who have achieved HBsAg~     loss would reverse back to HBsAg positive, or even become HBV reactive with recurrence of~     viremia. In current study, the viral and HBsAg response in patients who have achieved HBsAg~     loss by interferon (IFN) treatment will be observed for 96 weeks after the completion of IFN~     treatment. The primary analysis will be performed at the end of 96 weeks. Following the~     completion of the study period of 96 weeks, patients will be offered to participate in a long~     term study for further observation of additional 144 weeks (total of 240 weeks from the~     enrollment).~   "
94028|NCT02336386|"~     The purpose of this study is to determine whether Cyclophosphamide, Liposome doxorubicin and~     Dexamethasone（CDD) Plus Bortezomib might have effective in extramedullary plasmacytoma.~   "
94029|NCT02336373|"~     Sickle cell disease (SCD), specifically hemoglobin SC disease (HbSC), is a subtype of sickle~     cell disease with typically higher hemoglobin and milder or later disease complications.~     Sickle cell disease is a disorder in which red blood cells (RBCs) are abnormally shaped. This~     can result in painful episodes, serious infections, and damage to body organs. One medication~     used to treat sickle cell disease is hydroxyurea.~      Hydroxyurea therapy offers significant benefits for infants, children, and adolescents with~     sickle cell anemia. These include a reduction in the frequency of pain crises and acute chest~     syndrome (inflammation of the lungs). Hydroxyurea has been given to many HbSC patients but~     HbSC patients were not included in the large clinical trials used to test hydroxyurea in SCD,~     so less is known about how HbSC patients respond to hydroxyurea.~      The purpose of this research study is to see if hydroxyurea, a medication given to many~     children with the most common type of sickle cell, those who are homozygous for the sickle~     mutation (HbSS), helps children who have HbSC. The investigators will see if it helps by~     giving a questionaire when the medication is started, and then every two months at a clinic~     visit. The questionaire, called the Pediatric Quality of Life Inventory (PedsQL™) Sickle Cell~     Disease Module version 3.0, measures quality of life. The investigators will also see how~     hydroxyurea changes laboratory test numbers, and blood thickness.~   "
94030|NCT02336360|"~     This study will obtain data from urine in subjects administered 18F-AV-1451 in an~     Avid-sponsored study to augment the calculation of radiation dosimetry estimates.~   "
94031|NCT02336347|"~     To compare pharmacokinetics (PK) of AVP-786 (deuterated [d6] dextromethorphan hydrobromide~     [d6-DM]/quinidine sulfate [Q]) to AVP-923 (dextromethorphan hydrobromide [DM]/Q) at steady~     state.~   "
94032|NCT02336334|"~     Measuring and logging head positions of patients which underwent surgery with~     gasendotamponades.~   "
94033|NCT02336321|"~     In this study, 6 volunteer participants with chronic spinal cord injury will be invited to~     use an autonomous hand exoskeleton device controlled by a brain/neural-computer interaction~     (BNCI) system fusing electroencephalography (EEG) and electrooculography (EOG) to detect the~     intention of the user to grasp objects of daily life. The BNCI system consists of a~     lightweight hand exoskeleton connected to portable motors, rechargeable batteries and a~     computerized control system integrated into a wheelchair. Before, during and after use of the~     BNCI system the volunteers will perform standardized assessments and complete questionnaires~     to assess the functional and psychological effects of the exoskeleton. Functional outcomes~     primarily focus on motor function in performing daily life actions while psychological~     outcomes primarily focus on safety, reliability as well as predisposition and perceptions of~     disability.~   "
94054|NCT02336048|"~     This multicenter, double-blind, randomized, placebo-controlled study will evaluate the safety~     of a single infusion of tocilizumab versus placebo, administered in addition to standard~     premedications (antipyretic, antihistamine, and corticosteroid) prior to the first infusion~     of obinutuzumab administered in combination with oral chlorambucil to participants with~     previously untreated B-CLL who have comorbidities. All eligible participants will be treated~     with a total of 6 cycles of obinutuzumab + chlorambucil (cycle length = 28 days).~   "
94034|NCT02336308|"~     Burn-related pain is severe and often difficult to manage. Healthcare workers struggle with~     keeping burn patients comfortable, especially when these patients undergo dressing changes of~     their burn wounds of their skin since these procedures often cause severe pain. Patients with~     burn wounds frequently require high doses of opioids (narcotics) and calming (anxiolytic)~     agents to the extent that clinicians must weigh the risks associated with these doses against~     achieving adequate analgesia and comfort. The biggest risk is over-sedation to cause~     breathing troubles. Inadequate pain control during these procedures heightens pain~     perception, anxiety, and fear surrounding the experience and may lead to patients~     experiencing additional psychological disorders like depression, acute stress disorder (ASD),~     and post-traumatic stress disorder (PTSD). Therefore, therapeutic options for better~     management of pain and anxiety during these procedures need to be identified.~      This study will address whether the addition of ketamine during dressing changes improves~     patients' pain control and comfort and whether this leads to favorable psychological~     outcomes. The study is designed to compare ketamine with placebo when they are added to usual~     care (opioids and anxiolytics) during dressing changes. The main outcomes of the study will~     be the amount of opioid and anxiolytic agents each group receives during their procedure; the~     presence of pain-related anxiety shortly after the procedures; blood markers of stress during~     the procedures; and the presence of depression, anxiety and stress disorders prior to~     discharge. This study will assess whether the early administration of ketamine reduces pain~     and anxiety to prevent the need for high doses of opioids and anxiolytics. A total of 30~     patients will be enrolled.~   "
94035|NCT02336295|"~     The study aims to validate a Food Frequency Questionnaire (FFQ) designed specifically for the~     vegan population in Israel. The participants will complete the FFQ, and the data will be~     verified by evaluating the participants energy expenditure (by measuring BMR, body~     composition and daily activity) and conducting a 24-hour food interview.~   "
94036|NCT02336282|"~     A common and potentially debilitating late effect of childhood cancer treatment is~     neurocognitive impairment, frequently in the domain of executive dysfunction, which can limit~     educational attainment, employment, and quality of life. Among the survivors of childhood~     acute lymphoblastic leukemia (ALL) in the SJLIFE cohort, the frequency of executive function~     impairment has been shown as high as 58.8%, with moderate to severe impairment as high as~     33.5%, and risk for impairment increased with time from diagnosis. Given the potential of~     pervasive impact of neurocognitive impairment on daily life, interventions directed at~     reducing neurocognitive dysfunction among childhood cancer survivors with long-term follow-up~     are needed. This study examines the potential feasibility and efficacy of a novel~     intervention to improve executive function.~      Primary Objectives:~        -  To evaluate the feasibility of a home-based intervention using Transcranial Direct~          Current Stimulation (tDCS) and cognitive training in adult survivors of childhood ALL~          participating in the SJLIFE protocol at St. Jude Children's Research Hospital (SJCRH).~      Secondary Objectives:~        -  To estimate the efficacy of a tDCS intervention paired with cognitive training.~        -  To explore the short-term effect of tDCS on measures of executive function among adult~          survivors of childhood ALL participating in the SJLIFE protocol~   "
94037|NCT02336269|"~     Primex's PGX assay is an in vitro, semi automated assay, intended for the determination of~     certain genes involved in drug metabolism utilizing buccal swabs. Detection of certain~     genotypes is used as an aid in the selection of appropriate medications based on the~     individuals' specific genotype and should be used in conjunction with other clinical~     information. The results from this tests constitutes one parameter in a multicriterion~     medication selection process, encompassing both clinical and laboratory-based assessments.~   "
94038|NCT02336256|"~     Introduction: Any form of trauma, including surgery is known to result in oxidative stress.~     Single incision laparoscopy is a step forward towards almost scarless surgery. It is also~     expected to result in a lower degree of free radicals generation and faster normalization of~     the organism's antioxidant capacity.~      Aim: The aim of the study was to assess a number of plasma oxidative stress markers in~     patients operated due to inguinal hernia using typical totally extra peritoneal (TEP) and~     modified single incision laparoscopic surgery (SILS) methods.~      Material and methods: Thirty-two consecutive patients with no acute disease and severe~     chronic disorder, were qualified for inguinal hernia laparoscopic surgery. All were caucasian~     males, aged 24-69 and they underwent one of two surgical approaches: totally extra-peritoneal~     repair (TEP) and single incision laparoscopic surgery (SILS). TEP patients created Group 1~     (n= 17) and SILS patients formed Group 2 (n= 17). Total antioxidant status (TAS) and~     thiobarbituric acid-reacting substances (TBARS) were determined in three time points: before,~     one day and four days after the laparoscopic surgery.~   "
94039|NCT02336243|"~     This study evaluates the effectiveness of maternal supplementation with Docosahexaenoic acid~     (DHA) early in pregnancy to reduce the incidence of deep placentation disorders: preterm~     birth, preterm labor, preterm premature rupture of membranes, preeclampsia and fetal growth~     restriction. Half of the participants in early pregnancy will receive DHA 600 mg per day,~     while the other half will receive placebo. Investigators will study also the ability of DHA~     supplementation, early in pregnancy, to enhance invasion and transformation of spiral~     arteries by trophoblast, as deep placentation indicators.~   "
94040|NCT02336230|"~     The study plans to treat at least 60 pediatric subjects, male and female, between the ages of~     2 months and 17 years inclusive with acute Graft versus Host Disease (aGVHD) following~     allogeneic hematopoietic stem cell transplant (HSCT) that has failed to respond to treatment~     with systemic corticosteroid therapy. Subjects may have Grades C and D aGVHD involving the~     skin, liver and/or gastrointestinal (GI) tract or Grade B aGVHD involving the liver and/or GI~     tract, with or without concomitant skin disease.~   "
94041|NCT02336217|"~     The purpose of this pilot study is to determine the utility of an algorithm for better~     glucose control in diabetic patients communicated via an App to help improve outcomes and~     reduce urgent care and ER visits as well as improve A1C and quality of life.~   "
94055|NCT02336035|"~     Eligible patients that sign an informed consent will be randomized to operation with volar~     locking plate or cast immobilization. Primary follow-up after 1 year.~   "
94916|NCT02324764|"~     The objective of this study is to determine the rate of radial artery occlusion and vascular~     access site complications following transradial angiogram using a new Terumo (Tokyo, Japan)~     Glidesheath Slender, in comparison with the currently used 6 French (6 Fr.) radial sheath.~   "
94042|NCT02336204|"~     The increase of overweight and obesity in young Italian people, nowadays showed by several~     epidemiological data, has been related to the misuse of alcohol and to a lack in nutritional~     knowledge.~      Thus the aim of our study was to investigate if different nutritional knowledge from could~     affect body composition and drinking habits of a cohort of local young people.~      104 healthy subjects (56 males and 54 females) were recruited using oral advertisements among~     the students of 18-19 years-old belonging to the Istituto Agrario and the Istituto~     alberghiero Raineri-Marcora of Piacenza. The subjects were asked to complete a questionnaire~     on alcohol consumption and another one related to nutritional knowledge. Then anthropometric~     data were measured: height, weight, waist and hips circumferences, waist-hips ratio and~     skinfolds were evaluated for each subject and body fat mass was calculated.~   "
94043|NCT02336191|"~     A prospective Observational study including 50 living donor liver transplant recipients to~     monitor the graft functions through thromboelastometry~   "
94044|NCT02336178|"~     The purpose of this post-approval study is to evaluate the safety and efficacy of Benefix in~     subjects with hemophilia B in usual care settings in China.~   "
94045|NCT02336165|"~     This is an open-label, non-randomized, multicenter Phase 2 study of MEDI4736 with three~     non-comparative cohorts:~      Cohort A: 37 subjects with newly diagnosed unmethylated MGMT GBM will receive MEDI4736 every~     2 weeks in combination with standard radiotherapy.~      Cohort B: 30 bevacizumab-naïve subjects with recurrent GBM will receive MEDI4736 every 2~     weeks as monotherapy.~      Cohort B2: 32 bevacizumab-naïve subjects with recurrent GBM will receive MEDI4736 every 2~     weeks + bevacizumab every 2 weeks (10 mg/kg).~      Cohort B3: 32 bevacizumab-naïve subjects with recurrent GBM will receive MEDI4736 every 2~     weeks + bevacizumab every 2 weeks (3 mg/kg).~      Cohort C: 17 bevacizumab-refractory subjects with recurrent GBM will receive MEDI4736 every 2~     weeks in combination with continued bevacizumab.~   "
94046|NCT02336152|"~     To study if a one piece body suite (T-balance, Telespro, Finland) is equally effective in~     maintaining peri-operative body temperature as forced air warming, during open low-back~     surgery of medium duration.~   "
94047|NCT02336139|"~     To evaluate the proportion of patients with undetectable HCV RNA at 12 weeks post end of~     treatment (SVR12) following sofosbuvir/GS-5816 therapy for 12 weeks in people with chronic~     HCV infection and recent injection drug use.~   "
94048|NCT02336126|"~     This is a pilot study of a biopsychological intervention program for adolescent chronic~     fatigue syndrome. The program is related to cognitive behavioral therapy, which has been~     proven beneficial in this disorders, but includes other mental techniques, such as emotional~     control and metacognitive elaboration.~      The aim of this pilot study is to explore a) patients' experiences and b) possible positive~     effects on symptoms. We hypothesise that the intervention will be regarded feasible by the~     patients, and that fatigue score will improve during the intervention period.~   "
94049|NCT02336113|"~     Earlier studies have shown that pharmacists detect and solve drug related problems (DRPs)~     when they are a part of the multidisciplinary treatment-team at hospital wards. However, in~     the Norwegian health care system, there is a lack of studies on the effect of pharmacist~     intervention on clinically relevant outcomes. Hospital readmissions has both clinical and~     economical negative effects, and time outside the hospital until an eventual readmission is~     considered as a clinical relevant outcome measure. The investigators are conducting a~     randomized controlled trial at an internal medicine ward at Oslo University Hospital. 400~     acute admitted patients using minimum 4 regular drugs from minimum 2 drug groups will be~     enrolled in the study. Patients randomized to the Control group will receive standard care~     (without a pharmacist involved) and patients randomized to the Intervention group will~     receive a pharmacist in their treatment team during the hospital stay. The study hypothesis~     is that including a pharmacist in the multidisciplinary treatment team at a hospital ward,~     will improve the patients drug treatment, hence lead to an increased time outside the~     hospital until an eventual readmission.~      The investigators have approved protocol amendment to use the data from the study. The~     investigators aim to identify these patients by building a statistical model based on~     significant variables from the data collected in the ongoing randomised controlled trial. The~     hypothesis for the first part of the project is that a set of patient characteristics can~     identify patients who are at high risk of drug-related readmissions and who would benefit~     most from the pharmaceutical intervention. The model will be validated using data from 100~     new patients admitted to the internal medicine ward.~   "
94050|NCT02336100|"~     Gastroesophageal reflux disease (GERD) patients without obvious mucosal break by endoscopy~     were examined by FICE, followed by confocal. Validity scores for MERD diagnosis were~     analyzed.~   "
94051|NCT02336087|"~     This pilot phase I trial studies the side effects of gemcitabine hydrochloride, paclitaxel~     albumin-stabilized nanoparticle formulation, metformin hydrochloride, and a standardized~     dietary supplement in treating patients with pancreatic cancer that cannot be removed by~     surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride and paclitaxel~     albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of~     tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them~     from spreading. Metformin hydrochloride, used for diabetes, may also help kill cancer cells.~     Dietary supplements (curcumin, vitamin D, vitamin K2, vitamin K1, B-6, high selenium broccoli~     sprouts, epigallocatechin gallate, L-carnitine, garlic extract, genistein, zinc amino~     chelate, mixed toxopherols, ascorbic acid, D-limonene) can block different targets in the~     cancer cell simultaneously and may slow down cancer growth. Giving gemcitabine hydrochloride,~     paclitaxel albumin-stabilized nanoparticle formulation, and metformin hydrochloride with a~     dietary supplement may work better in treating patients with pancreatic cancer that cannot be~     removed by surgery.~   "
94052|NCT02336074|"~     This study will be a two-arm prospective 1:1 randomised controlled trial comparing:~      Arm A: cART preferably including raltegravir (combination ART cART - control) Arm B: cART~     preferably including raltegravir (cART) plus ChAdV63.HIVconsv (ChAd) prime and MVA.HIVconsv~     (MVA) boost vaccines; followed by a 28-day course of vorinostat (10 doses in total).~      We hypothesise that this intervention in primary HIV infection will confer a significant~     reduction in the latent HIV reservoir when compared with cART alone.~   "
94053|NCT02336061|"~     The purpose of this study is to evaluate of gender differences on the psychosocial and~     economic impact in patients with advanced non-small cell lung cancer.~   "
94056|NCT02336022|"~     Pediatric postoperative patients are at increased risk for post-operative respiratory~     complications such as hypoventilation. There is no objective measure of early respiratory~     parameters that would predict respiratory compromise after surgery efficiently in pediatric~     patients. Current respiratory assessment in non-intubated patients relies on oximetry data,~     impendence respiratory rate monitor and subjective clinical assessment. Pulse oximetry has~     been extremely helpful in recognizing oxygen desaturations but it is a late indicator of~     respiratory decline. New advances in technology and digital signal processing have led to the~     development of an improved impedance based Respiratory Volume Monitor (RVM). The RVM~     (ExSpiron™, Respiratory Motion, Inc.; Waltham, MA) has been shown to provide accurate~     real-time, continuous, non-invasive measurements of tidal volume (TV), minute ventilation~     (MV) and respiratory rate (RR) mostly in adult patients. The investigators' primary~     hypothesis is that the non-invasive, impedance-based RVM monitor will accurately reflect TV,~     RR and MV in pediatric patients.~   "
94057|NCT02336009|"~     Total wrist arthroplasty (TWA) surgery has developed gradually and can offer patients with~     rheumatoid arthritis/osteoarthritis reduced wrist pain with mainly preserved wrist range of~     movement. Each year 60-70 patients in Sweden are operated with a total wrist arthroplasty.~     Several implants are available on the market and they all have different pros and cons. One~     risk with a total wrist arthroplasty is loosening of the implant. If an implant is loose,~     revision of the implant to another TWA is sometimes possible, if not, a wrist fusion is the~     likely alternative. Revision rates five years after the index operation have improved,~     however, they cannot yet compare with the results after a total hip arthroplasty. A newly~     designed TWA has been developed by the department of Hand Surgery, Örebro university~     Hospital, Örebro, Sweden, in cooperation with Trimed Inc. The newly developed TWA offers~     theoretical advantages and has been biomechanically tested at the Mayo clinic.~      This is a pilot study where patients operated with the TWA will be assessed pre and~     postoperatively according to study protocol in order to evaluate outcome after TWA~     radiologically, clinically and regarding patient perceived outcome measures.~   "
94058|NCT02335996|"~     Identifying hypercortisolism patients at risk for cardio-vascular events despite biological~     cure, and determine which patients should be particularly followed. Hypercortisolic patients~     represent an ideal in vivo model to determine the interactions between glucocorticoids and~     ectopic fat development.~   "
94059|NCT02335983|"~     The purpose of the study is to assess the safety, tolerability and activity of a once-weekly~     regimen of carfilzomib in combination with lenalidomide and dexamethasone for the treatment~     of multiple myeloma.~   "
94060|NCT02335970|"~     This study evaluates the effect of a training intervention after thoracoabdominal resection~     of the oesophagus. Half of the patients scheduled for thoracoabdominal oesophagus surgery~     were randomized to an intervention group while the other half a control group.~   "
94061|NCT02335957|"~     The main purpose of this study is to show the non-inferiority of the incidental irradiation,~     as compared to intentional irradiation of the axillary nodes, in terms of 5-years~     disease-free survival (DFS) of early stage breast cancer patients with limited affectation of~     sentinel node assessed by OSNA (250 to 15,000 copies/uL), treated with breast-conservative~     surgery without axillary lymphadenectomy.~   "
94062|NCT02335944|"~     The study is designed to determine the maximum tolerated dose (MTD) or recommended phase 2~     dose (RP2D) of EGF816 in combination with INC280 and to estimate the preliminary anti-tumor~     activity of EGF816 in combination with INC280 in patients with advanced non-small cell lung~     cancer (NSCLC) with documented EGFR mutation.~   "
94063|NCT02335931|"~     The project concerns a type of very debilitating diabetic foot complications called Charcots~     osteoarthropathy (COA). This disease is characterized by a rapidly progressing destruction of~     the load bearing joints, primarily in the feet, resulting in loss of structure and~     remodeling. Untreated this cascade leads to the collapse of the bones, meaning severe pain~     and walking disability for the patient. Reconstruction is often very difficult or impossible,~     and furthermore the collapse can lead to chronic foot ulcers and infections, which in the~     worst case can be fatal.~      Treatment options are currently limited to early diagnosis and physical offloading~     (immobilisation), assisted wound healing and surgical intervention.~      The purpose of this project is to investigate and describe the bone-related factors, which~     separate COA from other, less acute, diabetic foot changes. The investigators wish to~     describe the long term consequences of COA - both anatomically, physiologically and~     biochemically.~      The investigators will be doing this in a follow-up investigations on a group of COA patients~     tested 8 years ago. Little is known of the long term changes to the bone structure after~     acute COA, and the investigators want to visualize to what extend the bone damage is~     permanent.~      To do this the investigators will be using DXA-scans, x-ray, blood tests including bone~     markers, neurophysiological tests and occlusion plethysmography.~   "
94064|NCT02335918|"~     This is a study to determine the clinical benefit (how well the drug works), safety, and~     tolerability of combining varlilumab and nivolumab (also known as Opdivo® , BMS-936558). Both~     drugs target the immune system and may act to promote anti-cancer effects.~   "
94065|NCT02335905|"~     This research study is looking at an antibiotic medicine, Ceftaroline Fosamil (Ceftaroline),~     which fights infections like the one the subject has. Ceftaroline is effective against~     S.aureus germs including those that are called Methicillin Resistant Staphylococcus aureus~     (MRSA.)~      Ceftaroline has been approved by the U.S. Food and Drug Administration (FDA) for use in~     adults and children with Community-Acquired Bacterial Pneumonia [a type of lung infection]~     and Acute Bacterial Skin and Skin Structure Infections. Ceftaroline is not yet approved for~     treatment in subjects with hematogenous osteomyelitis, therefore, the use of Ceftaroline in~     this research study is considered investigational.~      The goal of this research study is to find out what side effects there may be when children~     are taking Ceftaroline and to study how effective Ceftaroline is in treating bone infections~     due to Staphylococcus aureus in children. The investigators are also studying what the body~     does to the study drug, Ceftaroline, and if the doses the investigators use result in blood~     levels that the investigators think are going to be effective against bone infections in~     children. This is called pharmacokinetics (PK).~   "
94066|NCT02335892|"~     Multi centre, prospective, non interventional study in 200-240 UK relapsing remitting~     multiple sclerosis patients. Patients will complete questionnaires at baseline, 3, 6 and 12~     months.~   "
94068|NCT02335866|"~     The main objective of this study was to evaluate the clinical effectiveness of platelet-rich~     fibrin membrane used in combination with a coronally advanced flap and to compare it with the~     use of a subepitelial connective tissue graft in combination with a coronally advanced flap~     in Miller class I-II bilateral gingival recession treatment~   "
94069|NCT02335853|"~     Nerve growth factor (NGF-R) receptors are between the detrusor muscle fibers and can cause~     afferent signals. Metabolic syndrome and obesity have been advocated to be risk factors for~     the development of overactive bladder.~   "
94070|NCT02335840|"~     Introduction: reduction of blood pressure after physical exercise is called post exercise~     hypotension (PEH). However, previous studies demonstrate that ingestion of caffeine~     equivalent to three tea-cup of coffee abolishes this phenomenon. Objective: evaluate the~     influence of different doses of coffee in PEH. Methods: eleven hypertensive performed four~     experimental sessions of aerobic exercise in cycle ergometer (40 minutes of duration,~     intensity between 60% and 80% of maximum heart rate) succeeds for the ingestion of one~     (CAF-1), two (CAF-2), three (CAF-3) doses of caffeinated coffee (144 mg/dose), or three doses~     of decaffeinated coffee (DESC). Blood pressure was measured in rest and during 120 minutes of~     recovery post exercise, each 10 minutes.~   "
94071|NCT02335827|"~     The purpose of this study is to investigate the safety and efficacy of irreversible~     electroporation (IRE) for unresectable renal tumors.~   "
94072|NCT02335814|"~     This first-in-human (FIH) clinical trial is a Phase 1/1b, open-label, sequential-group,~     dose-escalation and cohort expansion study evaluating the safety, PK, PD, and antitumor~     activity of FLX925 in subjects with relapsed or refractory AML.~   "
94073|NCT02335801|"~     The objective of this study is to determine whether the presence of metabolic alteration and~     anabolic deficiencies in patients with chronic heart failure are able to identify a subset of~     patients with poor outcome.~   "
94074|NCT02335788|"~     This is an open label, acute, non-randomized, prospective, first in man (FIM) single-center~     study of the EMBA Medical Peripheral Embolization Device (PED).~   "
94075|NCT02335775|"~     The purposes of this study are to determine whether total lymph node count or the percentage~     of identified nodes with metastatic disease are influenced by (1) the method of categorizing~     tissue specimens or (2) the techniques of pathologic processing following lymphadenectomy.~      Patients with newly diagnosed endometrial carcinoma of high risk histologic type or uterine~     carcinosarcoma whose risk of LN metastasis exceeds 15% will be enrolled on this study.~     Patients will undergo staging to include hysterectomy and selective lymphadenectomy as per~     the clinical judgment of the primary Gynecologic Oncologist. Type of hysterectomy and the~     extent and distribution of lymphadenectomy is at the discretion of the surgeon. All patients~     will be scheduled for surgical staging. Each subject will have lymph nodes harvested on one~     side divided into specific basins, and on the contralateral side classified only as pelvic~     or aortic. Surgical node specimens in the operating room will be labeled by (1) specific~     nodal basins on the randomly determined side as external iliac, obturator, common~     iliac, aortic, or high aortic and by (2) pelvic versus aortic (common iliac nodes~     will be considered as part of the pelvic specimen) on the contralateral side.~   "
94076|NCT02335762|"~     40 healthy subjects were recruited using advertisements posted at the Catholic University of~     Piacenza, between January and October 2012. Height (using a stadiometer) and weight (using a~     Gima scale) of each subject were measured and the body mass index (BMI) was calculated~     (kg/m2). Subjects who satisfied inclusion criteria were instructed on how to document all~     food and drink consumed daily for 3 days using a diary previously used in the Italian~     National Survey INRAN-SCAI. They were asked to eat as usual in subsequent 3 days to emulate~     as best their habits. They were educated to report also the place, time, number and quantity~     of serving portions consumed. If they were not able to weight exactly each portion, a~     photographic atlas developed for the Italian component of the European Prospective~     Investigation into Cancer and Nutrition (EPIC) study was used. At the end of the three days~     the food diaries were checked and for each subject the energy intake was estimated.~   "
94077|NCT02335749|"~     Evaluate the safety and efficacy of the ZELTIQ CoolSculpting System using a small area~     applicator for non-invasive subcutaneous fat reduction in the distal thigh.~   "
94078|NCT02335736|"~     The antagonist protocol in a novel method of stimulation in the in vitro fertilization (IVF)~     patients. It has been tried in poor responders, polycystic ovary (PCO) patients and normal~     females undergoing IVF. Can it be used with the same efficacy in all patients?~   "
94079|NCT02335723|"~     The primary objective of this clinical investigation is to investigate the feasibility and~     possible benefits of the Alteco® LPS Adsorber in treating patients with septic shock with~     presumed endotoxemia of abdominal or urogenital origin.~   "
94080|NCT02335710|"~     Smith & Nephew's first edition of the Journey posterior stabilizing total knee arthroplasty~     was analyzed by the Center for Musculoskeletal Research in a past research study, and it was~     determined that subjects experienced more normal-like kinematic patterns. They also achieved~     excessive axial rotation and a decrease in weight-bearing knee flexion. Since Smith & Nephew~     has made modifications to the Journey bi-cruciate stabilizing (BCS) total knee arthroplasty~     (TKA) design, researchers will again evaluate the kinematics of subjects implanted with the~     revised design to determine if subjects experience normal-like kinematic patterns and if~     greater weight-bearing knee flexion is achieved. The objective for this study is to analyze~     the in vivo kinematics for subjects implanted with a 2nd generation Journey BCS TKA and~     compare those patterns to subjects having a normal knee and those having the 1st generation~     Journey posterior stabilizing (PS) TKA that were analyzed in the previous study.~   "
94090|NCT02335580|"~     The prevalence of portal vein thrombosis (PVT) in patients with liver cirrhosis is 5-20%.~     Current evidence regarding the effect of portal vein thrombosis on the prognosis of cirrhotic~     patients remains under debate. Considering that PVT potentially elevates the portal pressure~     and thereby increase the risk of variceal bleeding, we focus on the patients with high-risk~     varices and variceal bleeding as the study population. Thus, the main goals are to analyze~     the effect of PVT on the incidence of first variceal bleeding in patients without any prior~     bleeding history but with high-risk varices, the incidence of recurrent variceal bleeding in~     patients with a history of variceal bleeding, and the treatment failure rate of variceal~     bleeding in patients with acute variceal bleeding. Certainly, the survival is also observed~     in all patients.~   "
94081|NCT02335697|"~     Female circumcision (FC) causes both immediate and long-term health consequences. In general,~     the more severe type of FC, the worse health consequences can be seen. Despite the negative~     health effects, the practice of FC is still found to be highly prevalent in many countries,~     mainly in Africa and the Middle East. Many studies have been performed on FC in African~     countries where the custom is widespread and there have also been many attempts to eradicate~     the practice in these countries. However, considerably less research exists on FC in~     non-practicing societies where there has been an influx of immigrants from countries that~     traditionally carry out this practice. Further, no anti-FC interventions designed using a~     comparison group have been performed in any country outside Africa.~      This cluster randomized controlled trial aims to evaluate the effectiveness of a~     community-based participatory intervention on changing attitudes towards FC among newly~     arrived Somali immigrants in Sweden. Included in the research is an assessment of the~     acceptability of the intervention. Based on social convention theory, we hypothesize that an~     interaction between established Somali immigrants, thought to be predominantly opponents of~     FC, and newly arrived Somali immigrants will facilitate changes in attitudes among the newly~     arrived.~      The trial will be implemented in two municipalities in Sweden that have a high proportion of~     Somali immigrants. Somali organizations in these municipalities will constitute the clusters.~     In total, 8 clusters will be included, 4 intervention clusters and 4 control clusters.~   "
94082|NCT02335684|"~     This randomized trial has been designed to study if it is possible to enhance work capacity~     during submaximal efforts in heart failure patients supported with continuous-flow left~     ventricular assist devices (CF-LVAD).~      The hypothesis is that exercise tolerability during low to moderate workloads in CF-LVAD~     patients can be increased when pump speed is increased soon after the onset of exercise.~   "
94083|NCT02335671|"~     The purpose of this study is to investigate the use of intra-operative Magnetic Resonance~     Imaging (MRI) and Mass Spectrometry (MS) during breast conserving surgery, and to determine~     if these tests are capable of accurately predicting the presence or absence of breast tumor~     in surgical specimens at the margins.~   "
94084|NCT02335658|"~     The study evaluates the long term safety of DSP-5423P in patients with schizophrenia.~   "
94085|NCT02335645|"~     This case series will follow standard ACL protocol, while using biomechanical movement~     analysis to analyze running mechanics using a body weight supported treadmill.~      Standard ACL protocol will be followed throughout the treatment of each patient. The only~     variance from treatment will be using motion analysis software to analyze gait patterns at~     different points throughout the rehabilitation.~      The first motion analysis will be performed at week 6 of the rehabilitation process. Prior to~     this treatment, manual muscle testing of the hip, knee and ankle using a handheld~     dynamometer, two outcome measures, range of motion, pain, and patient satisfaction will be~     performed. At this treatment, motion capture sensors will be placed on the patient at~     different anatomical positions. The patient will then run in a body weight supported~     treadmill. During this run, video capture will be performed and later analyzed to determine~     biomechanical kinematics.~      This process will be repeated at week 8 of rehabilitation in the body weight supported~     treadmill.~      At week 10, the patient will shift treatment from the body weight supported treadmill, to a~     standard treadmill. The process will be repeated using the same anatomical landmarks and~     video capture.~      The final video capture will be performed at week 12. At this visit, video capture will be~     performed. The patient will also repeat all test, measures, and questionnaires from week 6.~      At all visits between video capturing, standard PT will be performed with a focus on patient~     deficits and following the standard protocol.~   "
94086|NCT02335632|"~     Background/Aims:~      The investigators explored the therapeutic effects of probiotics in patients with AH.~      Methods:~      Between December 2012 and January 2015, the investigators conducted a 7-day,~     double-controlled, randomized, prospective clinical trial comparing the efficacy of~     probiotics in improving liver enzymes, LPS, pro-inflammatory cytokines, stool culture, and~     stool Polymerase chain reaction denaturing gradient gel electrophoresis. AH was defined as an~     aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2 and elevated AST (ALT)~     level with an alcohol consumption history within 48 hours. Patients were randomized to~     receive 7 days of cultured Lactobacillus rhamnosus R0011/acidophilus R0052 (120 mg/day) or~     placebo. The levels of liver enzymes, modified Discriminant Function (mDF), LPS, and~     pro-inflammatory cytokines, stool culture, and stool Polymerase chain reaction denaturing~     gradient gel electrophoresis were checked at baseline and again after therapy.~   "
94087|NCT02335619|"~     Currently at the BC Cancer Agency, oncologists decide when to refer a patient to the Pain and~     Symptom Management/Palliative Care (PSMPC) team, and their decisions are made subjectively~     and without standard guidelines/symptom assessment tools. Patients are often referred late in~     their treatment. The PSMPC team sees patients in their own clinic, separately from the~     oncologists, and do not often collaborate in a patient's care.~      Early integration of palliative care into oncological care has been shown to improve quality~     of life and to prolong survival, as well as to reduce inappropriately aggressive oncological~     care at end of life, and reduce costs of care. We will test an early oncology-integrated~     palliative care model, with the aims of determining whether 1) the introduction of PSMPC~     support at the time of diagnosis leads to better symptom management and quality of life of~     patients, 2) early integration of palliative care into medical oncology care reduces~     aggressiveness of cancer treatment near end of life, and 3) a fully integrated service~     delivery model is sustainable.~   "
94088|NCT02335606|"~     Abatacept Registry in Taiwan~   "
94089|NCT02335593|"~     The purpose of the study is to evaluate the effect of Zinc supplementation on health status~     of hemodialysis patients through measurement of the following before and after Zinc~     administration: Inflammatory markers, Oxidative stress markers and Anemia markers. Also,~     Evaluation of quality of life of hemodialysis patients before and after Zinc administration~     using Fatigue severity scale questionnaire.~   "
94091|NCT02335567|"~     To compare two competing newly designed 3D sequences for black blood carotid plaque imaging~     techniques with the industry standard 2D sequnce for black blood.~   "
94154|NCT02334735|"~     Vaccine adjuvants are compounds used to increase specific immune responses to antigens, but~     have minimal toxicity or lasting immune effects on their own. This study investigates the use~     of dendritic cells as an adjuvant for NY-ESO-1 and Melan-A/MART-1 peptides compared to~     Montanide® in study subjects with melanoma in complete clinical remission.~   "
94092|NCT02335554|"~     Depression is one of the most prevalent mental disorders to afflict adults. It seriously~     impacts role functioning and often takes a recurrent or chronic course. Because most adults~     who suffer from depression never receive treatment, there is a critical need to develop~     interventions that can be easily implemented and widely disseminated. Interventions that~     reduce the performance-impairing symptoms of subclinical depression and prevent the onset of~     major depression can improve employee well-being, while reducing healthcare costs and~     improving productivity. This project produced a mobile-web program to activate cognitive~     behavioral skills in workers with subthreshold depression, reduce depression symptoms,~     improve functioning in the workplace, and potentially reduce the risk for escalation to~     full-syndrome depression.~   "
94093|NCT02335528|"~     SimCoach, a computer program featuring a virtual human that speaks and gestures in a~     videogame-like interface, is designed to encourage servicemembers, especially those with~     signs or symptoms of post-traumatic stress disorder (PTSD) or depression, to seek help to~     improve their psychological health. The assessment included a formative component assessing~     SimCoach's design, development, and implementation approaches, as well as a summative~     component assessing outcomes among participants in a user experience survey and a randomized~     controlled trial (RCT).~   "
94094|NCT02335515|"~     The primary objective of the study was to assess the gastric residence time (GRT) of the~     Soctec capsule after a standardized breakfast. 12 healthy subjects will undergo an initial~     screening visit. Eligible subjects will undergo the study procedure. The hypothesis is that~     the GRT of the Soctect Capsule after a standardized breakfast and lunch will be longer~     compared to literature values reported for a simliar sized capsule.~   "
94095|NCT02335502|"~     04-SMI-2012 is post market, observational, questionnaire based study to assess the~     effectiveness of the commercially available Axium neurostimulator in the management of~     chronic, intractable pain.~   "
94096|NCT02335489|"~     14-SMI-2013 is a post market, observational, questionnaire based study to assess the~     effectiveness of the commercially available Axium neurostimulator in the management of~     neuropathic pain of the foot and/or lower limb~   "
94097|NCT02335476|"~     The investigators will use optical coherence tomography to detect the ex-vivo tissue image of~     surgical removed melanoma or other benign pigmented lesions of skin.~   "
94098|NCT02335463|"~     The investigators will use an advanced high resolution 3D optical coherence tomography (OCT)~     technology to observe colon and skin images in ex vivo.~   "
94099|NCT02335450|"~     This study evaluates the effectiveness of personalized physical activity coaching combined~     with the use of a physical activity monitor to support increased levels of daily physical~     activity in individuals with multiple sclerosis. All five participants will receive the~     intervention over the four week intervention phase.~   "
94100|NCT02335437|"~     Chronic fatigue syndrome (CFS) is characterized by unexplained, disabling and long lasting~     fatigue, as well as pain, impaired memory, sleep difficulties and other symptoms.~     Epstein-Barr virus (EBV) infection might precipitate CFS. In this study, 200 adolescents~     undergoing acute EBV infection will be followed prospectively, and also compared with a group~     of healthy controls. The aim is twofold:~        -  To identify factors that predispose to chronic fatigue among adolescents with acute EBV~          infection~        -  To compare pathophysiological features of patients with acute EBV infection with a group~          of healthy controls.~      Possible risk factors for chronic fatigue 6 months after EBV-infection includes:~        -  Severity of the initial infection~        -  Immune responses characteristics~        -  Characteristics of the neuroendocrine stress response~        -  Cognitive functioning~        -  Emotional disturbances~        -  Genetics/ epigenetics of candidate genes~        -  Certain personality traits~        -  Critical life events~   "
94101|NCT02335424|"~     This is a study using pembrolizumab (MK-3475, KEYTRUDA®) for first-line treatment of~     participants with advanced/unresectable (inoperable) or metastatic urothelial cancer who are~     ineligible for cisplatin-based therapy. The primary study objective is to determine the~     objective response rate (ORR) in all participants, in participants whose tumors rely on~     programmed cell death ligand 1 (PD-L1) protein (PD-L1-positive tumors), and in participants~     with strongly PD-L1-positive tumors.~   "
94102|NCT02335411|"~     This is a study of pembrolizumab (MK-3475) for advanced gastric or gastroesophageal junction~     adenocarcinoma; pembrolizumab will be given as monotherapy to participants who have had~     previous treatment or who are treatment-naïve; pembrolizumab will also be evaluated as~     combination therapy with cisplatin and 5-Fluorouracil (5-FU) or (Japan only) capecitabine in~     treatment-naïve participants. The primary study hypothesis is that pembrolizumab will provide~     a clinically meaningful Overall Response Rate (ORR).~   "
94103|NCT02335398|"~     Methadone is a synthetic mu opioid agonist that has been proved as clinically effective in~     pain management. However, methadone usage for pain control in Thailand has been limited~     because physicians are not familiar with its dosing and concern about the risk of drug~     accumulation and cardiac arrhythmia. Therefore, this prospective study was conducted to~     evaluate the efficacy and safety of a methadone protocol in Thai patients with severe chronic~     noncancer and cancer pain.~   "
94104|NCT02335385|"~     Conventional laparoscopic varicocelectomy using 3 ports has been used for treatment of~     varicocele in our department since the nineties. However, the relatively several trocar~     wounds represent a big challenge against its acceptance by many of our patients who prefer~     the open approach with one or at least two wounds.~      Single incision laparoscopic surgery (SILS), since its introduction in 2007, has been proven~     to be feasible and effective, with high patient satisfaction rates regarding improved~     cosmotic outcomes, reduced postoperative pain, and rapid return to normal activities. (10,~     11) SILS for varicocelectomy has been reported to be safe and effective alternative to~     conventional laparoscopic varicocelectomy in a few studies.~   "
94105|NCT02335372|"~     Objectives:~      Primary Objective: To perform a pilot clinical study to test multi-modal optical imaging for~     detection of cervical neoplasia in Brazil.~      Secondary Objective: Analyze clinical data to establish the imaging modes which demonstrate~     the highest degree of correlation with disease state.~   "
94106|NCT02335359|"~     The purpose of this study is to determine whether tranexamic acid is effective in reducing~     intraoperative blood loss and necessity for haemotransfusion in patients undergoing open~     abdominal aortic aneurysm repair~   "
94108|NCT02335333|"~     The primary purpose of this study is to measure the correlation between baseline expression~     of aging biomarkers, SenesceTest in blood of organ donor and renal graft function. This pilot~     study will study patients who are undergoing renal transplantation with organs from extended~     criteria donors, standard criteria donors or donation after cardiac death and compare ability~     of SenesceTest to predict renal graft function immediately after the transplant and at 1 year~     followup.~   "
94109|NCT02335320|"~     Acute or chronic HCV infection can lead to liver complications, including liver failure,~     cirrhosis or liver cancer. For patients with hepatitis C infection, the major clinical~     question remains the terms of treatment initiation. In Europe, new treatments are available~     since the approval of three direct acting antivirals. However with the high cost of these~     treatments, they are currently only available for critically ill patients. Other molecules~     are currently in advanced clinical development phases. The use of clinical predictors remains~     relevant for the selection of a suitable treatment for each patient, in particular to limit~     the adverse effects and reduce costs. Currently the quantification of viral load is a measure~     of response to treatment; with the recommendation to stop treatment in patients who fail to~     achieve an undetectable level of viral load. Genetic factors have also been identified as~     predictors of response to treatment, in particular polymorphisms of the IL-28B gene.~     Genotyping of this gene is currently performed using classical PCR amplification applied to~     DNA extracted from blood, with a time to result of 2-3 weeks. We propose in this protocol to~     test a non-invasive method and rapid test for IL-28B genotype which could be used for point~     of caring testing, and ultimately better patient management.~      This is a monocenter, cross-sectional study among HCV chronic patients. The study will be~     conducted in 250 HCV patients, all viral genotypes combined, at Cochin Hospital (Paris,~     France).~      Objectives The principal objective is to assess the accuracy of the newly developed~     Point-of-Care genotyping assay (Genedrive® IL-28B Assay) to detect in HCV patients the~     genotype CC versus non CC (i.e. CT and TT) against the TaqMan Allelic Discrimination Assay as~     gold standard.~      The secondary objective is to assess the concordance between the genotype results of the~     Genedrive and the gold standard regarding the three genotypes CC, CT and TT.~   "
94110|NCT02335307|"~     This study will examine the effect of having genotype information on pain management and pain~     control for patients treated in family medicine clinics. This study will also examine~     physician-perceived usefulness of genotype information. Patients will be enrolled from family~     medicine clinics serving as either implementation sites or control sites. Patients from~     implementation sites will undergo genotyping, while those from control sites will not by~     genotyped.~   "
94111|NCT02335294|"~     The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with~     placebo in patients with acute postoperative pain following abdominoplasty.~   "
94112|NCT02335281|"~     There are many limitations in the current treatments of Inflammatory bowel disease (IBD). Now~     the investigators realized that the intestinal microecological is closely associated with the~     development of IBD. So the standardized fecal microbiota transplantation is considered to be~     simple but effective emerging therapies for the treatment of IBD. In this project the~     investigators intend to carry out a single-center, randomized, single-blind clinical~     intervention study. The investigators will recruit 40 patients with IBD (20 cases of~     Ulcerative Colitis and 20 cases of Crohn's disease) in China. The patients will be randomly~     divided into 2 groups, one group will be given treatment of standardized fecal microbiota~     transplantation, the other will be simply treated with mesalazine, followed up for at least 1~     year. The investigators propose to determine the efficiency, durability and safety of~     Standardized Fecal Microbiota Transplantation for IBD treatment.~   "
94113|NCT02335268|"~     There are currently no licensed drugs in the EU to treat thrombocytopenia in MDS patients~     classified as IPSS low/int-1. Prior studies with romiplostim (a TPO receptor agonist) in MDS~     found that baseline concentration of TPO as well as transfusion history were predictive of~     subsequent response in a retrospective model. The current prospective study has the aim to~     explore whether both pretreatment variables (endogenous TPO, TPO-level, platelet transfusion~     history) can predict the response to subsequent short-term treatment with romiplostim.~   "
94114|NCT02335255|"~     To compare the efficacy and safety of the test formulation Naftifine Hydrochloride Gel 2% to~     Naftin® (Naftifine Hydrochloride) Gel 2%~   "
94115|NCT02335242|"~     A Phase 2 study to evaluate safety and efficacy of sildenafil taken orally to improve or~     resolve lymphatic malformations in children. Subjects may receive either placebo or treatment~     in an oral dosage with an open label extension for subjects who received placebo. The study~     treatment assignment will be randomized in a double blind fashion. MRI examination will~     evaluate change in lesion volume due to treatment. Other safety and efficacy measures will be~     taken through the 32-week study duration.~      Funding Source - FDA OOPD~   "
94116|NCT02335229|"~     20-SMI-2013 is a post market, observational, questionnaire based study to assess the~     effectiveness of the commercially available Axium neurostimulator in the management of~     chronic post surgical pain~   "
94117|NCT02335216|"~     18-SMI-2013 is a post market, observational, questionnaire based study to assess the~     effectiveness of the commercially available Axium neurostimulator in the management of~     chronic pain following lumbar discectomy (Failed Back Surgery Syndrome)~   "
94118|NCT02335203|"~     Objective: To compare pre- and post-treatment glandular cellularity in women with complex~     atypical hyperplasia or grade 1-2 endometrial adenocarcinoma who are treated with~     intramuscular depot medroxyprogesterone acetate (DMPA) versus placebo injection prior to~     hysterectomy. The secondary objective is to compare various other outcomes including~     molecular, histologic, pathologic and clinical endpoints in women treated with DMPA versus~     placebo prior to hysterectomy.~      Hypothesis: Patients treated with DMPA will have significantly decreased glandular~     cellularity post-treatment when compared to patients treated with placebo injection. Patients~     treated with DMPA will exhibit previously described changes in molecular tumor marker~     expression patterns and other characteristic histologic changes. Patients treated with DMPA~     will report less bothersome vaginal bleeding prior to surgery when compared to patients~     treated with placebo injection.~      Study Design: Double blinded randomized controlled trial~      Population: Women being treated at the Women and Infants Program in Women's Oncology who have~     a biopsy-proven diagnosis of complex atypical hyperplasia or grade 1-2 endometrial~     adenocarcinoma with disease clinically confined to the uterus, with a plan to undergo~     hysterectomy.~      Study Period: February 2015 to June 2016~   "
94155|NCT02334722|"~     The purpose of this study is to see if there are any differences between patients who receive~     Levetiracetam extended-release tablets for one week after surgery to remove a brain tumor~     versus those who receive Levetiracetam extended-release tablets for six weeks after surgery.~     Specifically, we will see if one group has less side effects than the other, and whether or~     not one group has more seizures than the other.~   "
94119|NCT02335190|"~     The sacroiliac (SI) joint is a common source of low back pain. Radiofrequency ablation (RFA)~     can be used to treat low back pain from the SI joint , and is often recommended by physicians~     to provide long lasting pain relief. However, the use of RFA for SI joint pain has not been~     as successful as RFA for pain in other areas of the back and neck. X-ray guidance~     (fluoroscopy) is currently used to perform this procedure. Under fluoroscopy, however, it can~     be difficult for physicians to identify necessary landmarks, and there are risks to the~     patient because of radiation exposure. In contrast, ultrasound may provide better image~     guidance than fluoroscopy, and there is no radiation risk. The purpose of this study is to~     examine if ultrasound guided SI joint RFA is effective.~   "
94120|NCT02335177|"~     Elderly people are still at risk for falling at home. The objective of the study is to~     evaluate at home the impact of an intervention for 3 months combining technologies for~     autonomy and tailored physical activity program. The study is performed among patients aged~     75 years and over leaving Charles Foix Geriatrics hospital or already supported by carer of~     professional home-care service Ages & Vie and with a loss of autonomy requiring physiotherapy~     and home support workers. It is a prospective, randomized, single-center, in cluster study~     which compares a Patient group (interventional group) with the intervention program~     (technologies + physical activities) with a control group benefiting from usual care home.~     Our hypothesis is that in the interventional group fewer falls were observed and improved~     different scores (Timed Up and Go Test,Barthel index, Quality of Life questionnaire of Duke)~     were reported compared to the control group.~   "
94121|NCT02335164|"~     Recombinant hemagglutinin has been shown to induce protective neutralising antibodies against~     avian influenza virus but is relatively non-immunogenic. An ideal pandemic avian influenza~     influenza vaccine would combine hemagglutinin antigen with an appropriate adjuvant to~     increase its immunogenicity. This Phase 1 study will collect preliminary human safety and~     efficacy data on combined formulations of recombinant hemagglutinin with Advax adjuvant~     formulations administered by intramuscular injection~   "
94122|NCT02335151|"~     Proportion of circulating tumor cells (CTC) in the postoperative phase after curative tumor~     removal of pancreatic cancer will be determined and correlated to the accordance of~     anesthesia (desflurane versus propofol)~   "
94123|NCT02335138|"~     The proposed research aims to address the question: Compared to the current standard of care~     for home-based HIV tests, in which persons conduct and interpret HIV tests without~     counseling, does the addition of video conferencing with a remote counselor increase~     health-enhancing, protective behaviors among male-male couples and facilitate linkage to care~     for those who test positive?~   "
94124|NCT02335125|"~     The goal of this pilot study is to develop and implement a larger scale, multi-site stepped~     collaborative care trial that targets injured patients with presentations of Posttraumatic~     Stress Disorder (PTSD) and related comorbidity.~   "
94125|NCT02335112|"~     The purpose of this study is to evaluate the safety and efficacy of irreversible~     electroporation (IRE) for unresectable Head and Neck Neoplasms.~   "
94126|NCT02335099|"~     This study is a randomized, placebo-controlled, single blind clinical trial. Seventy patients~     with ESRD on chronic HD and a functioning AVF will be recruited. The following data will be~     documented on each patient: 1-Age/gender/race/body weight/cause of ESRD 2-Vintage of HD~     3-Time since access was placed 4-Type and place of access and blood flow rate of access~     5-History of prior access problems 6-Comorbid conditions (Hypertension, coronary artery~     disease, Diabetes Mellitus, Bleeding problems, peripheral vascular disease). 7-Current~     medications (Coumadin, Erythropoiesis stimulating agents, heparin, other antiplatelets,~     digoxin, statins). Patients will be randomized into two groups to receive: Group 1:~     Ticagrelor 90 mg PO BID Group 2: Placebo drug PO BID.~   "
94127|NCT02335086|"~     The purpose of this study is:~        1. To examine the association between stable and unstable coronary artery disease (CAD)~          with markers of DNA damage and repair,~        2. To examine the association between plaque morphology as assessed by frequency-domain~          optical coherence tomography (FD-OCT) and markers of DNA damage and repair in order to~          identify potential markers of plaque instability,~        3. To examine the association between markers of DNA damage and repair and major adverse~          cardiovascular events defined as death, MI and unplanned percutaneous or surgical~          revascularization,~   "
94128|NCT02335073|"~     Liver biopsy is the reference method for the measurement of liver fibrosis. But it has many~     limitations, such as sampling error and individual variation in interpreting the results.~     Currently, serum liver fibrosis markers have been employed as non-invasive diagnosis of liver~     fibrosis and evaluation of the severity of liver fibrosis. They include laminin (LN),~     hyaluronic acid (HA), collagen type IV (CIV), and N-terminal propeptide of collagen III~     (PIIINP). However, few study was conducted to explore the role of these liver fibrosis~     markers in evaluating the prognosis of liver cirrhosis. Our hypothesis is that LN, HA, CIV,~     and PIIINP in combination or alone can predict the prognosis of liver cirrhosis.~   "
94129|NCT02335060|"~     The overall purpose of this study is to examine the effect of N-acetylcysteine (NAC) on the~     acute effects of Delta-9-tetrahydrocannabinol (THC). This will be tested by pretreating~     healthy individuals with NAC and then assessing their responses to THC.~   "
94130|NCT02335047|"~     Passive flexion of the trunk (relative to the legs) may be accompanied by contraction of the~     psoas muscles, even when the subject has been told not to contract any muscles. The psoas~     contraction is involuntary and cannot be controlled by the subject. This lack of passivity~     might be concomitant with lower back pain: the impairment may be present when lower back pain~     is present and/or absent when lower back pain is absent.~      The study's primary objective is thus to determine the sensitivity and/or specificity of a~     clinical test for impaired hip flexor passivity in cases of lower back pain during passive~     flexion of the trunk (from the supine position,).~      The secondary objective is to show that a negative test (after administration of correcting~     measures) is correlated with a decrease in pain (i.e. pain intensity and the functional~     repercussions of pain).~   "
94166|NCT02334579|"~     The purpose of this study is to find out the effects (good and bad) of highly focused~     radiation on you and your prostate cancer. The purpose of this evaluation is to see if this~     treatment causes fewer side effects that other standard treatment approaches, and to evaluate~     the effect of this treatment on your prostate tumor and your quality of life over time.~   "
94131|NCT02335034|"~     OBJECTIVE: To evaluate the improvement of patients with gonarthritis exposed to a~     multidisciplinary care program with and without associated classroom educational program.~     METHODS: 152 patients (men and women) aged 40 or older with arthritis stages I to III of~     Kelgren and Lawrence. Have been treated with drugs, orthotics and referred to physical~     rehabilitation (physiotherapy and/or physical activity). Patients will be randomized into 2~     groups of 76 and will go through pre-assessment with multidisciplinary team: Psychologist -~     assess cognitive ability; level of anxiety, and depression. Nutritionist - anthropometric~     parameters and diet quality. Social Worker - Level of education, religion, autonomy and~     mobility capacity to the hospital. Physiotherapist - range of motion, pain, function and~     quality of life. Occupational Therapy - range of motion and strength. Physical Educator -~     level of physical activity and functional capacity. Orthopaedic - additional examinations,~     disease classification, orthotics, report to Social Security and Traffic Department,~     evaluation questionnaires (SF 36, VAS, WOMAC, LEQUESNE), referral to physical therapy,~     physical activity and inform consent. A group will submitted to two interventions, with an~     interval of two months between each intervention. The control group will only make~     evaluations / consultations with all professional teams without classes for 2 years, then~     will attend the courses and will be followed by two more years. Interventions will be~     lectures and practices with the seven professional teams, covering the topic arthritis~     (orthopedic team), what is disease, being ill, and the role of the patient in the treatment~     (psychology) to obtain behavioral change. Lectures and practices with physical therapy and~     occupational therapy to show the importance of exercise in relieving symptoms (physical~     therapy), the importance of rest and proper ergonomics at home and at work (occupational~     therapy). The nutritionist shows proper alimentation. Lecture and practice with physical~     educator (showing the difference between the laber work and regular physical activity as well~     as the importance of strength exercises, resistance and stretching) and theoretical class~     with the social service by calling attention to the importance of leisure. After two months,~     the second intervention is made in order to verify the acquired concepts. Six months, 1, 2, 3~     and 4 years after the first evaluation, the groups will be called to new multi evaluation.~   "
94132|NCT02335021|"~     The purpose of this study is to investigate the effects of dietary exposure to artificial~     sweeteners on taste sensitivity, preference and brain response in adults. The investigators~     hypothesize that dietary exposure to artificial sweeteners (sucralose) will decrease~     sensitivity to taste, shift preference of sweet and savory taste to a higher dose, and reduce~     brain response in amygdala to sweet taste compared to sucrose.~   "
94133|NCT02335008|"~     The goal of this study is to test the hypothesis that repeated consumption of artificial~     sweetener reduces sweet taste intensity.~   "
94134|NCT02334995|"~     Dissynergic defecation causes solitery rectal ulcer. The biofeedback therapy improves~     dissynegy and heals soliter rectal ulcer.~   "
94135|NCT02334982|"~     The purpose of this study is to characterize the safety and tolerability profile of TAK-137~     when administered as a single dose of tablets at escalating dose levels in healthy~     participants.~   "
94136|NCT02334969|"~     The purpose of this study is to assess the efficacy and safety of Naoxintong Capsule in the~     secondary prevention of ischemic stroke by the multi-center,~     randomized,double-blind，placebo-controlled trial design project.~   "
94137|NCT02334956|"~     120 individuals with alcohol, cannabis or nicotine dependence as well as healthy controls~     will be administered a whole-brain imaging exam. The current research project constitutes a~     highly novel approach to understanding the pathophysiology of addiction through its~     combination of neuroimaging with state-of-the-art information concerning the real-time~     expression of risk factors.~   "
94138|NCT02334943|"~     Immune Activation persists in HIV-1 infected patients despite efficient antiretroviral~     treatment. This immune activation is responsible for immune deficiency as well as for~     non-AIDS related comorbidities, such as non-alcoholic Fatty liver disease, metabolic syndrome~     or osteoporosis. The goal of this observational transversal multicentric study is to~     establish the etiologic factors of persistent immune activation in treated HIV-1 infected~     patients (persistent de novo infection of T CD4+ cells, microbial translocation, active~     coinfections, immunosenescence, T CD4+ cells lymphopenia, Treg deficiency), its different~     forms ( activation of T CD4+ cells, T CD8+ cells, B cells, NK cells, monocytes, granulocytes,~     platelets, endothelial cells or general inflammation) and the potential correlation between~     causes, forms of immune activation and emergent comorbidities (kidney, bone or liver~     dysfunction, metabolic syndrome).~   "
94139|NCT02334930|"~     PEComa is rare tumor affecting particularly patients with Tuberous Sclerosis. Biological~     similarities were seen between PEComa and infantile hemangioma. Propranolol is highly~     efficient to treat infantile hemangioma and we believe that this drug can also be useful for~     the treatment of PEComa.~      Purpose : to understand the mechanism of action of propranolol in PEComas and related~     pediatric vascular lesions and to select possible novel targets of betablockers in vascular~     tumors related to PEComas by using YAP oncogene activation as a molecular marker~   "
94140|NCT02334917|"~     This study is being carried out to assess equivalence of scar outcome for two absorbable~     sutures used for wound closure on the face in dermatologic surgery: rapidly absorbable~     polyglactin 910 (VicrylRapide™) and fast-absorbing plain gut (5-0 fast). This is important~     because absorbable sutures are commonly used in Mohs surgery for epidermal closure, yet there~     is no evidence indicating if any of the sutures above allow for a better cosmetic outcome~     (less erythema, edema, and scarring).~   "
94141|NCT02334904|"~     Significant changes in brain morphology are observed in people with first-episode psychosis.~     Studies have shown that total brain volume and particular brain structures are decreased in~     people with psychosis disorders. Recent evidence suggests that some atypical antipsychotic~     drugs can maintain or increase brain volumes. Thus, we plan to use MRI scans to measure~     changes in brain morphology in subjects recently diagnosed with bipolar or psychosis~     disorders who are taking the atypical antipsychotic drugs aripiprazole or risperidone.~     Secondary objectives include taking blood samples for fasting metabolic indices and~     neuropsychiatric measures for comparisons between drug treatments.~   "
94142|NCT02334891|"~     The purpose of this study is to investigate the patient characteristics, selection of~     treatment, and factors associated with clinical outcomes in Japanese patients with acutely~     decompensated congestive heart failure.~   "
94143|NCT02334878|"~     This study evaluates the effectiveness of mesenchymal stem cells in treatment of stress~     urinary incontinence due to intrinsic sphincter deficiency; in which the problem is weakness~     or damage of the sphincter muscle responsible for continence. Mesenchymal stem cells are~     undifferentiated cells which can undergo self-renewal & differentiation into other cell types~     like muscle cells; thus can be used to regenerate the damaged sphincter muscles. In this~     study mesenchymal stem cells will be obtained from bone marrow from the patient, processed, &~     then re-injected periurethrally. Effectiveness will be compared to that of the surgical~     treatment (tension-free vaginal tape).~   "
94192|NCT02334241|"~     The aim of this study is to demonstrate, during a 12-week follow-up, a greater efficacy of~     using Sorbact® dressing technology in addition to best local cares compared to best local~     cares alone in the management of diabetic foot ulcers~   "
94144|NCT02334865|"~     This phase I trial studies the safety of SVN53-67/M57-KLH peptide vaccine in incomplete~     Freund's adjuvant together with sargramostim in treating patients with newly diagnosed~     multiple myeloma who are receiving lenalidomide maintenance therapy. Vaccines made from~     survivin peptide may help the body build an effective immune response to kill cancer cells~     that express survivin. Incomplete Freund's adjuvant may help stimulate the body's immune~     response to a vaccine treatment. Colony-stimulating factors, such as sargramostim, may~     increase the production of blood cells. Lenalidomide may stop the growth of cancer cells by~     blocking some of the enzymes needed for cell growth. Giving SVN53-67/M57-KLH peptide vaccine~     in incomplete Freund's adjuvant and sargramostim before or after the start of lenalidomide~     maintenance therapy may be a better treatment for multiple myeloma.~   "
94145|NCT02334852|"~     The AF is the most common arrhythmia in clinical practice affecting 1-2% of the general~     population. It is the most common cause of cerebrovascular events (CVE), responsible for 25%~     of all ischemic strokes and 50% of cardioembolic strokes.~      The CARMEN-AF registry is planned to be the first registry of non-valvular AF in Mexico with~     national representation, planning and specific objectives for publications. Follow-up period~     of two years is planned.~   "
94146|NCT02334839|"~     Preeclampsia toxemia (PET) is a pregnancy related complication that is usually expressed as~     new onset hypertension and proteinuria after 20 weeks of gestation. scarce data exists~     regarding the effectiveness of PAT plethysmography use in women with PET and whether adverse~     results are found compared to healthy gravidas. Thus, we aimed to assess endothelial function~     using PAT plethysmography in women with PET and compare their results to both healthy~     gravidas and those with only gestational hypertension.~   "
94147|NCT02334826|"~     The purpose of the study is to investigate the extent of ischemia and left ventricular~     function in cardiovascular magnetic resonance (CMR), as well as patency of coronary arteries~     and grafts in coronary computed tomography angiography at 12 months follow up in patients~     with advanced coronary artery disease treated with percutaneous coronary intervention with~     the implantation of bioresorbable scaffolds or coronary artery bypass graft surgery.~      Additionally, the clinical results of the two methods of revascularization will be carried~     out annually up to 5 years.~   "
94148|NCT02334813|"~     Patients above age 18 with a first episode of immune thrombocytopenia are randomized 1:1~     between 2-4 weeks of daily prednisone (1 mg/kg/d) with subsequent dose tapering (arm A) and~     six 3-week cycles of pulsed dexamethasone (0.6 mg/kg/d, days 1-4; arm B). The primary~     endpoint is duration of remission defined as platelets ≥50/nl.~   "
94149|NCT02334800|"~     This is a phase 1 study to describe the plasma pharmacokinetics of a single oral 75mg dose of~     palbociclib administered to healthy volunteers, and subjects with mild, moderate, and~     severely impaired hepatic function.~   "
94150|NCT02334787|"~     To assess the safety (especially skin findings) and pharmacokinetics by applying 0.3%, 1%, or~     3% formulation of 5g OPA-15406 ointment to a 1000 cm2 area as a single-dose and as a~     multiple-dose twice daily for 2 weeks in Japanese healthy adult male subjects.~   "
94151|NCT02334774|"~     Endotracheal intubation may contribute to the difficulties in swallowing and subsequent oral~     intake. Estimated 62% of patients who had been intubated ≧48 hours will experience~     post-extubation dysphagia. Clearly, intervention is needed but studies are lacking in this~     regard. Thus, the objective of this pilot trial is to evaluate effects of an Oral Swallowing~     Care Program on swallowing and oral intake status in patients following prolonged~     endotracheal intubation.~      This study employs a before-and-after intervention design. We will enroll 80 post-extubated~     adult patients (50 years old and older) who had prolonged (≥48 hours) oral endotracheal~     intubation from six medical intensive care units at a medical center in Taipei, Taiwan.~     Participants will be assessed within 48 hours post-extubation for the baseline data, then a~     14-day, daily Oral Swallowing Care Program involves moisturizing and cleansing oral cavity,~     massaging salivary gland, oral motor exercise, and intake education will be provided. Outcome~     will be assessed on 7th, 14th, and 21st day post-extubation including oral health status,~     oral sensation (stereognosis, light touch and two-point discrimination), tongue and lip~     strength, salivary secretion, body weight. In addition, Three-Step Swallowing Screen (3-SSS)~     and Functional Oral Intake Scale will be assessed daily. The data will be analyzed by SAS 9.3~     software package.~   "
94152|NCT02334761|"~     Over the past decade the paradigm of care in oncology has evolved with the advent of~     personalized medicine. Yet, despite this exciting prospect, there are currently only a few~     disease subtypes where therapeutic approaches with proven benefit exist such as EGFR targeted~     therapies in EGFR-mutant lung tumours. With the increasing number of novel molecularly~     targeted agents available, the importance of building our understanding of cancer biology is~     critical.~      Challenges to implement personalized medicine include the limitations of molecular testing,~     tumour heterogeneity and molecular evolution, costs, and the quality and morbidity associated~     with tumour biopsies. Sequential biopsies are essential to better understand biological~     markers of response and resistance, and identify predictive or prognostic markers. Despite~     the scientific rationale for biopsies, incorporating them into practice can be challenging,~     as in many cases there is no direct advantage to the patient. This project aims to understand~     the effect of research biopsies on the patient. The Investigator hypothesize by learning more~     and gaining a better appreciation of the impact on the patient, Investigators will increase~     the likelihood of achieving serial biopsies.~      The ability to obtain serial biopsies is dependent on the patient's experience. To understand~     the clonal progression of cancer and validate predictive and prognostic markers of response,~     studies now target biopsies both at enrollment and at progression. As Investigators strive to~     achieve this, improving our understanding of the patient's experience will help us identify~     factors that positively and negatively impact on patient participation and influence the~     probability of successfully obtaining sequential samples.~   "
94153|NCT02334748|"~     The objective of this extension protocol is to collect safety data (serious and non-serious~     adverse events) and to provide continuous canakinumab to patients in France who completed~     study CACZ885G2301E1, CACZ885G2306 or CACZ885N2301 until a decision regarding reimbursement~     in France is effective for canakinumab (Ilaris®) in these indications.~   "
94953|NCT02324283|"~     Which is more adequate general anesthetic agent, desflurane or propofol, for emergence and~     recovery time, and perioperative oxygenation in lung resection surgery?~   "
94156|NCT02334709|"~     Tyrosine kinase inhibitors (TKIs) are often used in the standard treatment for patients with~     metastasized renal cell carcinoma. In addition to their ability to specifically inhibit tumor~     growth, TKIs also interfere with the vascularisation of the tumor. Unfortunately, most~     patients do not obtain long-lasting clinical benefit from this treatment. The goal of the~     current study is to enhance the effect of TKIs by combining them with stereotactic~     radiotherapy treatment of one of the metastases. This type of radiotherapy allows us to~     precisely irradiate the tumor with minimal effect on the surrounding healthy tissue. Recently~     it has been demonstrated that this type of radiotherapy stimulates the immune system to~     attack the tumor. By combining stereotactic radiotherapy with TKIs we expect to observe a~     reduction of metastases in a bigger population of patients.~      In the first part of our study we focus on the safety of the combination therapy. In the~     second part we will evaluate the combined treatment response.~   "
94157|NCT02334696|"~     The IMPROVA study is designed to identify novel predictors of vascular access success or~     failure. Clinical assessment complimented by Doppler ultrasound is the only currently~     employed methods of assessing suitability for placement of arteriovenous fistulae (AVF).~     These techniques are not capable of predicting vascular access outcomes suggesting that other~     potentially measurable factors may play a part.~      Despite efforts to improve placement of AVF in both the haemodialysis incident and prevalent~     population, many patients continue to dialyse through a central venous catheter (CVC),~     exposing them to higher risks of infection, co morbidity and mortality than dialysing via an~     AVF. Furthermore, AVF primary failure rates are reportedly as high in 20-50% in published~     series confirming that ultrasound cannot inform the clinician sufficiently to accurately~     predict success or failure.~      The aim of this study is to perform enhanced assessments of arterial health preoperatively~     and correlate these measurements with early AVF outcome. We intend to perform pulse wave~     analysis and velocity; measure advanced glycation end products and assess endothelial~     function using a vascular occlusion test. We also aim to assess whether patient reported~     symptoms of hand function can predict AVF outcome. These non-invasive measurements will~     provide a more accurate picture of overall vascular health prior to AVF formation with the~     ultimate intention of informing the clinician as to the likelihood of success or failure.~   "
94158|NCT02334683|"~     This study seeks to compare the use of ultrasound and electrophysiologic techniques to target~     muscles for the treatment of spasticity and focal dystonia of the limbs. The purpose of this~     study is to investigate the use of two ways of locating the muscle for botulinum toxin (BoNT)~     injection for the treatment of focal hand dystonia and upper limb spasticity.~     Electrophysiologic guidance, using electrical stimulation, and ultrasound are the standard~     ways of locating muscles during a treatment of BoNT injection.~   "
94159|NCT02334670|"~     It is hypothesized that implementing plasma CrAg screening in clinics providing routine HIV~     care will enable identification of Vietnamese adult patients with advanced HIV (CD4 ≤100~     cells/μL) who have early cryptococcal disease, enable prompt preemptive treatment with~     high-dose fluconazole, and improve survival.~   "
94160|NCT02334657|"~     Spontaneous subarachnoid hemorrhage (SAH) is usually caused by rupture of an intracranial~     aneurysm, but in up to 15% of patients with spontaneous SAH, no discernible bleeding source~     can be identified despite of repetitive radiological imaging. Patients, at least 18 months~     after ictus of a non-aneurysmal SAH, received a regular mail including a letter explaining~     the study purpose and the postal questionnaire consisting a short-form health survey with 36~     simple questions. If we didn't receive answers after three months we made telephone~     interviews with the patients' family members or their general practitioner.~   "
94161|NCT02334644|"~     This study will evaluate the effectiveness of 12-weeks of probiotic treatment in adults with~     primary Obsessive-Compulsive Disorder and whether this treatment will alter the microbiota~     composition in these patients.~   "
94162|NCT02334631|"~     Video capsule endoscopy (VCE) is a procedure where a small camera is swallowed to examine the~     small bowel. Although the procedure is useful for diagnosing small bowel diseases, air~     bubbles can obscure the recorded images. Simethicone is a medication that can be used to~     disperse the air bubbles. However, prior studies using this medication have shown only a~     modest benefit. In our study, we would like to investigate whether increasing the amount of~     medication will improve the recorded images further.~   "
94163|NCT02334618|"~     The purpose of this study is to use a novel load monitoring technology to correlate limb~     loading to ankle fracture outcomes. This study will collect continuous limb loading data and~     will provide the first objective insight into how limb loading directs fracture healing.~   "
94164|NCT02334605|"~     Nasal hyper reactivity is defined as an increased sensitivity of the nasal mucosa to stimuli~     such as temperature changes, changes in humidity, emotional stress, physical activity, smoke~     and/or other scents and gives often rise to nasal symptoms such as rhinorrhea, nasal~     obstruction and/or sneezing.~      nasal hyper reactivity is a clinical feature of rhinitis and rhinosinusitis, affecting more~     than 20% of the total Western population.~      Cold, dry air exposure has been shown to be a reliable method for diagnosis of nasal~     hyperreactivity. The new, shorter protocol for cold dry air provocation that recently has~     been validated as a useful diagnostic tool to evaluate nasal hyperreactivity with high~     specificity and sensitivity, is already a major step forward but still rather time-consuming~     and not always very practical in use.~      A hyperosmolar saline solution loaded on a small nasal sponge as described earlier has also~     been reported as being an effective means of evaluation of nasal hyperreactivity. In~     addition, capsaicin nasal spray has also been reported as being an elegant tool for the~     evaluation of the response of TRP channels on the nasal mucosa.~      So far, we lack data on the comparison between the 3 different diagnostic tools for the~     evaluation of nasal hyperreactivity in rhinitis.~   "
94165|NCT02334592|"~     Health Canada's Radiation Emitting Devices (RED) Act provides exposure time guidelines for~     sunbed use. These guidelines are intended to protect sunbed users from overexposure to UV~     radiation. Overexposure is defined as exposure that exceeds the amount needed for vitamin D~     production and could lead to skin or eye damage. Acute overexposure induces sunburn.~     However, the effect of the recommended time exposure schedule on serum 25(OH)D response has~     not been characterized. Further, it is unknown if the maximum time exposures are required to~     reach and/or maintain optimal 25(OH)D levels. The aim of the current study is to characterize~     serum 25(OH)D response to regular sunbed use following the time exposure schedule recommended~     by Health Canada.~   "
94167|NCT02334566|"~     Immigrant and refugee children and youth are the fastest growing segment of Canadian society,~     but their mental health is too often overlooked even though their high rates of symptoms are~     increasingly of concern. These children and youth face the same developmental challenges as~     other children, but migration and resettlement amplify challenges and also create additional~     risks. Although a literature about the effects of immigrant family life on the mental health~     of children exists, very little research has examined the specific extent and implications of~     post-traumatic stress disorder (PTSD) among refugee children and youth. In addition, the best~     practice intervention strategies that most optimally support their mental health difficulties~     have not been evaluated. This study investigates the effectiveness of a treatment~     intervention in a sample of refugee children: Narrative Exposure Therapy or NET and KIDNET~     (developed for younger children), selected due to their documented superiority relative to~     other forms of treatment for children and youth with PTSD.~   "
94168|NCT02334553|"~     Evaluate the safety and tolerability of a single dose of S-1226 (8%) in subjects with mild~     atopic asthma.~   "
94169|NCT02334540|"~     The satiety effects of pulses compared to a matched smoothie will be measured.~   "
94170|NCT02334527|"~     This multicenter phase II trial will evaluate palbociclib (PD-0332991) in patients with~     metastatic urothelial carcinoma (UC) with cyclin-dependent kinase inhibitor 2A (CDKN2A) (also~     referred to as p16) loss and positive Retinoblastoma (Rb) expression after failure of~     first-line chemotherapy.~   "
94171|NCT02334514|"~     The purpose of this study is to determine the duration of viral shedding in hospitalized~     patients with influenza virus, treated with oseltamivir.~   "
94172|NCT02334501|"~     This is an open label, 2-period, fixed-sequence study in 15 healthy adult subjects under fed~     conditions. To evaluate the effect of multiple doses of lansoprazole on the absorption and~     pharmacokinetics (PK) of a single dose of neratinib in healthy subjects.~   "
94173|NCT02334488|"~     Prospective, multicenter, randomized and open label study evaluating the benefit on renal~     function at 12 months post-transplantation, with an immunosuppression without calcineurin~     inhibitor at 3 months and combining mycophenolate sodium-Everolimus versus an~     immunosuppression combining Everolimus-Tacrolimus, in de novo renal transplant patients.~   "
94174|NCT02334475|"~     Chronic low back pain, with or without lower extremity pain, which arises from various~     structures of the spine constitutes a majority of pain complaints. The sacroiliac joint (SIJ)~     has been implicated as the primary source of pain in 10% to 27% of patients with mechanical~     low back pain below L5 vertebra. The common causes of SIJ pain include a trauma like direct~     fall on the buttocks, a rear-end or broad-side type motor vehicle accident, and an~     unanticipated step into a hole or from a miscalculated height, fusion surgery, anterior~     dislocation, inflammatory and degenerative sacroiliac joint disease and idiopathic. The~     treatment of SIJ pain remains a therapeutic challenge. Besides physiotherapy and systemic~     therapies including non-steroidal anti-inflammatory drugs (NSAIDs) and biologic agents,~     intra-articular and peri articular injections of SIJ, radiofrequency neurotomy and surgical~     fusion are often performed for pain relief. However, the success of these interventions has~     been determined according to the therapeutic efficacy and correct placement of the drug. The~     image guidance of SIJ injections seems to be important due to the complex anatomy of the~     joint causing a low accuracy when performed according to clinical judgement only. The~     feasibility of ultrasound (USG) guided injection of SIJ has recently been demonstrated~     resulting in very high success rates up to 90%. Various agents being used in SIJ injections~     include local anaesthetics, corticosteroid, botulinum toxin-A, 12.5% dextrose,~     phenol-glycerine-glucose (P2G) and sodium morrhuate (cod liver oil extract). SIJ steroid~     injection is commonly used technique and has been found to be effective to treat SIJ pain.~     However, the main drawback is short term effect. Borowsky et al reported improvement in~     visual analog score (VAS) of 14.1% and reduction of VAS ≥ 50% in only 12.50% patients at 3~     months after intra-articular steroid (2 mL 0.5% bupivacaine plus 40 mg methylprednisolone)~     SIJ injection. Treatment modalities being currently used do not, in general, address the~     disease process itself, there is clearly a need to investigate treatments that are more~     widely applicable for symptom management and which may also directly address the disease~     process itself. Current research efforts aim at modifying the rate of healing of joint by~     using biological healing factors which are various growth factors (transforming growth~     factor, vascular endothelial growth factor, fibroblast growth factor, epidermal growth~     factor, platelet derived growth factor etc.) found abundantly in the human blood especially~     in platelets. The platelet rich plasma (PRP) is an ideal autologous biological blood-derived~     product, which can be exogenously applied to various tissues where it releases high~     concentrations of platelet derived growth factors that enhance the body's natural healing~     response. In addition PRP possesses antimicrobial properties that may contribute to the~     prevention of infections. PRP is now being widely tested in different fields of medicine for~     its possibilities in aiding the regeneration of tissue with low healing potential. Local~     injection of PRP is a new modality which has been effectively used for the treatment of~     Achilles tendon injury in athletes, chronic epicondylar tendinopathy, chronic patellar~     tendinosis, rotator cuff tear, anterior cruciate ligament injury, gonoarthrosis and plantar~     fasciitis. The intra-articular injection of PRP into knee joint has been found to reduce the~     incidence of local inflammatory changes in early knee osteoarthritis. Recently, PRP has been~     used for low back pain caused by SIJ laxity showing significant improvement in pain scores.~     However, there is no study at present comparing the efficacy of intra-articular injection of~     PRP with corticosteroids for the treatment of chronic SIJ pain. Considering the vast~     potential of PRP and its safety, this study aimed at studying the efficacy of ultrasound~     guided intra-articular SIJ injection of leukocyte free PRP for chronic low back pain due to~     SIJ pathology. In the current study, we tested the hypothesis that the SIJ injection of~     leukocyte-free PRP may be more effective for the treatment of sacroiliac joint pain as~     compared with steroid injection.~   "
94175|NCT02334462|"~     Background:~      - Malaria is a severe infection caused by a parasite. People can get malaria if a mosquito~     that carries the parasite bites them. Malaria infection does not happen in the United States,~     but many people in Africa, Asia, and South America are at risk for it. Researchers want to~     test two vaccines that may help decrease malaria infection.~      Objective:~      - To see if two vaccines (Pfs25M-EPA/Alhydrogel and Pfs230DIM-EPA/Alhydrogel ) are safe in~     humans and cause an immune response that will prevent malaria parasites from correctly~     growing in the mosquito.~      Eligibility:~      - Healthy adults ages 18 50.~      Design:~        -  There are several groups in this study. Each group will receive a different dose of the~          vaccine and some groups will received both vaccines.~        -  Vaccinations will be given on two days about 4 weeks apart.~        -  Participants will receive each vaccine as an injection into the arm. Blood will be drawn~          on the day of vaccination.~        -  In the 4 weeks after receiving a vaccination, participants will have at least 3 clinic~          visits and 1 phone contact. They will have at least 3 more visits and 3 phone contacts~          over the next 6 months.~        -  At each visit, participants will be evaluated for side effects to the vaccine and any~          new health changes or problems. They will be asked how they are feeling and if they have~          taken any medicine. Blood and urine samples may be taken at the visit. More follow-up~          visits may be needed to follow up on changes or problems.~   "
94176|NCT02334449|"~     Phase I study to assess the safety, tolerability and pharmacokinetics of ascending single and~     multiple doses of the investigational medicinal product in healthy volunteers~   "
94177|NCT02334436|"~     The primary objective is to demonstrate the safety and efficacy of DWP-450 (Botulinum~     purified neurotoxin, Type A) Injection in the treatment of moderate to severe glabellar lines~     associated with corrugator and/or procerus muscle activity in adult subjects~   "
94178|NCT02334423|"~     The primary objective is to demonstrate the safety and efficacy of DWP-450 (Botulinum~     purified neurotoxin, Type A) Injection in the treatment of moderate to severe glabellar lines~     associated with corrugator and/or procerus muscle activity in adult subjects~   "
94179|NCT02334410|"~     After a complete spinal cord injury (SCI), the patient becomes wheelchair-dependent, and the~     associated lack of weight-bearing and inactivity of paralysed muscles can lead to extensive~     bone loss in the long bones of the legs. It has been documented that the most rapid phase of~     bone loss is during the first year, but bone loss can continue for a number of years~     post-injury, leading to an increased risk of fracture in chronic SCI. Through a previous~     longitudinal study, in which we described rates of bone loss in the first year of SCI using~     peripheral Quantitative Computed Tomography (pQCT), we showed that there is a subset of~     patients who suffer from extremely rapid bone loss, losing up to 50% of their bone mineral~     density (BMD) in the first 12 months post-SCI. As a result of this work, we now know that, by~     performing repeat bone scans within months of injury, we are able to detect and red-flag~     those patients at highest risk of rapidly weakening bones. We propose that, once these~     patients have been identified, there is an opportunity to intervene with bone-stimulating~     interventions within months of injury, before BMD reaches dangerously low values. In this new~     phase of the research, therefore, we are introducing an intervention phase to the~     longitudinal pQCT study. For this, we aim to trial a physical intervention, Whole Body~     Vibration (WBV), that could potentially reduce rates of further bone loss in fast bone~     losers. Vibration would achieve this by acting as a mechanical stimulus for bone cells, to~     encourage bone formation. If shown to be successful as an early bone-stimulating~     intervention, it may prove to be a tool for reducing future fracture risk in patients with~     SCI.~   "
94193|NCT02334228|"~     Few studies targeting obesity in serious mental illness have reported clinically significant~     risk reduction, and non have been replicated in community settings or demonstrated sustained~     outcomes after intervention withdrawal. The researchers sought to replicate positive health~     outcomes demonstrated in a previous randomized effectiveness study of the In SHAPE program~     across urban community mental health organizations serving an ethnically diverse population.~   "
94180|NCT02334397|"~     Operative vaginal delivery (with forceps or vacuums) is frequently performed secondary to~     maternal exhaustion, which leads to an inability to push effectively; 40% of operative~     vaginal deliveries at Prentice are for maternal exhaustion. The risk of severe birth trauma~     is increased three to four fold with operative delivery. This randomized, controlled trial~     will compare rates of operative vaginal delivery and severe birth trauma in two groups of~     women: (1) an intervention group who will participate in the antepartum Total Control®~     fitness and education program modified for pregnancy; and (2) a control group. Women will be~     recruited and followed from the second trimester until 6 weeks postpartum; all will complete~     validated questionnaires regarding their (1) level of worry and knowledge about their~     birthing experience (2) pelvic floor symptoms and quality of life (3) sexual function (4)~     satisfaction with their birthing experience and (5) level of depressive symptoms at various~     time points during and after their pregnancy. Obstetrical data will also be collected.~   "
94181|NCT02334384|"~     The goal of this study is to demonstrate safety and tolerability of a novel antimicrobial~     wound dressing, Antimicrobial TheraGauze. The unique microvillous structure of TheraGauze is~     ideal for the development of an antimicrobial wound dressing. In vitro testing has~     demonstrated that tobramycin is an ideal compound for integration into TheraGauze providing~     excellent killing of MRSA and other organisms that commonly cause wound infections.~     Tobramycin is a non-absorbable aminoglycoside that will be contained solely to the wound bed~     preventing any potential for systemic toxicities. In vivo testing of tobramycin-impregnated~     TheraGauze used in mouse wound models has confirmed no systemic absorption of tobramycin as~     demonstrated by undetectable blood levels. TheraGauze has been commercially available for 10~     years as a wound dressing. Tobramycin has been available for many years as a topical~     antibiotic as eyedrops and as an inhaled antibiotic for patients with cystic fibrosis,~     demonstrating excellent safety in both cases.~      This Phase I trial will test Antimicrobial TheraGauze (ATG) as an antimicrobial wound packing~     for patients presenting to an Emergency Department with skin abscess (furunculosis). Subjects~     will either receive ATG or standard of care wound packing (cotton wick or iodoform wick).~     Subjects will return to the ED in 2 days for wound packing removal and reassessment of their~     wounds and symptomatology. A final followup will be performed by a physician and study~     coordinator in an outpatient setting on day 7.~   "
94182|NCT02334371|"~     The importance of selecting patients with ovarian cancer who will benefit from either primary~     debulking surgery or neoadjuvant chemotherapy followed by interval debulking surgery has been~     acknowledged worldwide but the optimal diagnostic modality to serve in this matter remains to~     be discovered. We believe that combined magnetic resonance imaging and positron emission~     tomography (MR-PET) can be of great clinical value in preoperative staging of patients with~     ovarian cancer.~   "
94183|NCT02334358|"~     To evaluate long-term safety of YVOIRE classic s by incidence of adverse events including~     injection site local reactions and biodegradability~   "
94184|NCT02334345|"~     Radiotherapy may cause severe skin changes that significantly interfere with the patient's~     quality of life and may reduce radiotherapy effectiveness. Many skin care instructions and~     various topical agents are recommended to help patients in the management of radiation skin~     reactions, but evidence to support the value of the topical treatments of the irradiated skin~     is lacking. In the present study we investigated the effects of two topical agents used as~     supportive care to protect skin during radiotherapy.~   "
94185|NCT02334332|"~     This pilot clinical trial studies an educational brochure in preparing patients with gastric~     cancer and their caregivers for recovery after surgery. Giving an educational brochure may~     help prepare patients and their caregivers by improving knowledge about symptoms after~     surgery. It may also improve quality of life and reduce worry after surgery.~   "
94186|NCT02334319|"~     This pilot clinical trial studies how well ganetespib works before surgery in treating~     patients with stage I-IVA squamous cell carcinoma of the head and neck that can be removed by~     surgery. Ganetespib may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Studying samples of blood and tissue in the laboratory from patients~     receiving ganetespib may help doctors learn more about the effects of ganetespib on cells. It~     may also help doctors understand how well patients respond to treatment.~   "
94187|NCT02334306|"~     A Phase 2a study to evaluate the efficacy and safety of AMG 557/MEDI5872 in Primary Sjögren's~     Syndrome~   "
94188|NCT02334293|"~     The purpose of this study is to determine if a fat emulsion comprised of omega-3 fatty acids,~     Omegaven, would be beneficial in the management of steatotic liver injury in parenteral~     nutrition (PN) by its inhibition of de novo lipogenesis, the reduction of arachidonic~     acid-derived inflammatory mediators, prevention of essential fatty acid deficiency through~     the presence of small amounts of arachidonic acid, and improved clearance of lipids from the~     serum.~   "
94189|NCT02334280|"~     The goal of this project, which has not changed, is to evaluate the statewide implementation~     of a two-component intervention (health promotion plus academic detailing) with respect to~     consumer outcomes and changes in provider prescribing. The intervention, called In SHAPE, is~     delivered to people with serious mental illness (SMI) by two community mental health clinics~     (CMHCs). These CMHCs are compared to two CMHCs delivering usual-care to individuals with SMI.~     The specific aims of this study are:~        1. Evaluate person-level and provider-level outcomes including: (a) consumer health~          behaviors, health indicators, mental health indicators, and acute health service~          utilization, (b) provider prescribing practices and program fidelity, and (c) program~          costs.~        2. Evaluate system-level outcomes including: (a) consumer health behaviors and health~          indicators, (b) provider prescribing and program fidelity, and (c) acute services use.~   "
94190|NCT02334267|"~     This study is a prospective, single center, single blind (patient and laboratory),~     randomized, cross-over, two week investigation of intradialytic acid-base kinetics and~     physiology associated with use of two commercial acid dialysate concentrates in prevalent~     hemodialysis patients.~   "
94191|NCT02334254|"~     To evaluate the safety for the combination of Rivaroxaban and Ticagrel versus triple~     antithrombotic regimen (Vitamin K Antagonist (VKA), Clopigogrel and Aspirin) in patients with~     atrial fibrillation and coronary artery disease undergoing percutaneous coronary intervention~     (PCI).~   "
94954|NCT02324270|"~     To demonstrate the therapeutic efficacy of a generic diclofenac epolamine patch against~     Flector patch in the treatment of pain in subjects with minor ankle sprain~   "
94194|NCT02334215|"~     The purpose of this study is to determine which of three approaches started in jail is more~     effective in treating opioid use disorder: (1) methadone treatment without counseling (termed~     interim methadone) coupled with case management (termed patient navigation); (2) interim~     methadone without patient navigation; (3) or an enhanced treatment as usual including opioid~     detoxification, overdose prevention and drug treatment information and referral.~   "
94195|NCT02334202|"~     This research study is aimed at the prevention of excessive weight gain in female military~     dependents at high risk for adult obesity. The purpose of this study is to determine whether~     reducing Loss of Control (LOC) eating and associated indicators through use of interpersonal~     psychotherapy (IPT) will be feasible and acceptable to female adolescent dependents who~     report such behaviors. Moreover, patterns in the data will be examined to assess whether IPT~     influences body weight gain trajectories and prevent worsening disordered eating and~     metabolic functioning among female military dependents at heightened risk for unhealthy~     weight gain.~   "
94196|NCT02334189|"~     The study aims to test whether it is possible to reduce pressure on Emergency Departments by~     sending a personal feedback letter to people who have recently attended an Emergency~     Department and whose health issues could likely have been dealt with elsewhere. These~     attendances clearly have many causes. However, it is likely that some attendances are due to~     behavioural factors - in other words, the various ways in which users interact with services.~     This study focuses on one particular behavioural factor: lack of feedback to users making~     avoidable visits.~      The study will take place in collaboration with an NHS hospital trust. Each week during the~     trial, the hospital trust will identify those Emergency Department attendances in the last~     seven days which, according to clinical judgement, could have been dealt with elsewhere.~     Patients will then be randomly selected to receive a letter containing information on~     alternative healthcare options for non-emergency health concerns. Patient records will be~     analysed to determine whether the patients who received the letter are less likely to make an~     avoidable repeat visit to the Emergency Department in the future, compared with patients who~     received no letter.~   "
94197|NCT02334176|"~     The investigators conducted this prospective, randomized, observer-blinded, non-inferiority~     trial to compare single perivascular injection to double injection (musculocutaneous nerve~     and perivascular injection) US guided axillary brachial plexus block.~   "
94198|NCT02334163|"~     Evaluating the efficacy and safety of nitazoxanide in comparison to standard treatment in~     patients with grade II-III hepatic encephalopathy (HE). Also, Evaluating the effect of~     administering nitazoxanide on the improvement of patient's quality of life.~   "
94199|NCT02334150|"~     Combined spinal-epidural analgesia (CSEA) is sometimes used for difficult births, but whether~     it contributes to postpartum pelvic muscle disorder is unclear. This randomized controlled~     trial examined whether CSEA affects the electrophysiological index of postpartum pelvic floor~     muscle during labor. The investigators plan to recruit 300 primiparous healthy women.~   "
94200|NCT02334137|"~     The overarching purpose of this project is to provide diabetes education to the diverse~     patient population at the Lions Eye Clinic, a resident-run ophthalmology practice at~     California Pacific Medical Center. Because of high clinic volume in a teaching environment,~     our patients often experience long wait times. The goal of this program is to utilize this~     wait time for diabetes education, a much-needed corollary to the eye care that patients~     receive at our clinic.~      This pilot project will investigate the impact of a program like this in our patient~     population. Specifically, the investigators are investigating whether diabetes education~     delivered in an ophthalmology setting enhances patient understanding of diabetes (via~     knowledge surveys) and/or leads to improved blood glucose control (via hemoglobin A1c). This~     is a 6-month study that runs through April 2015, and looks at the impact of an interactive~     diabetes education iPad app +/- in-person sessions with a diabetes educator. A subset of~     patients who meet with a diabetes educator will also be shown their own retinal images~     (compared to a normal retina).~   "
94201|NCT02334124|"~     Many children every year present to the Emergency Department (ED) at The Royal Children's~     Hospital (RCH) with cellulitis (skin infection). If it is mild, the children can go home with~     oral antibiotic treatment. If it is complicated and severe, these children are admitted to~     hospital for intravenous (IV, through a drip) antibiotic treatment. There is a middle group~     with uncomplicated moderate/severe cellulitis who require IV antibiotics but who are not~     acutely unwell. In order to determine whether it is just as effective for children with~     uncomplicated moderate to severe cellulitis to receive antibiotic treatment at home (via~     Hospital-In-The-Home) as it is to receive antibiotic treatment in hospital, there is a need~     to conduct a larger study and randomly assign children to receive either HITH or hospital~     ward care.~      The primary research question to be addressed is:~      In children with moderate/severe uncomplicated cellulitis, is the failure rate at 2 days~     following the first dose of antibiotic non-inferior for children treated with IV antibiotics~     at home compared to the failure rate at 2 days following the first dose for children treated~     with IV antibiotics in hospital?~   "
94202|NCT02334111|"~     The impact of parental opioid use disorder and other substance use exposure on child welfare~     and the healthcare system is undeniable. Between 2000 and 2009, the number of delivering~     mothers using or dependent on opiates rose nearly five-fold, and it is estimated that 48-94%~     of children exposed to opioids in utero will be diagnosed with neonatal abstinence syndrome~     (NAS), a set of behavioral and physiological complications resulting from abrupt substance~     withdrawal at birth. Opioid abuse is usually coupled with use of other substances, and~     research has demonstrated that children born to parents with substance use disorders are~     three to four times more likely to suffer abuse or neglect.~      Currently, the standard of care for pregnant women who are being treated for opiate~     dependence at Boston Medical Center (BMC) is to receive all their prenatal care in the~     RESPECT Clinic, an innovative program of the BMC Department of Obstetrics and Gynecology~     designed to treat addiction during the prenatal and early postnatal period. Once the child is~     born, BMC staff files a report of suspected child abuse and neglect in accordance with the~     Massachusetts General Laws section 51A. The state Department of Children and Families makes a~     determination regarding the disposition of these families. Medically, most of these children~     are treated in-patient at BMC for NAS and then discharged to follow-up with routine pediatric~     primary care. Currently, approximately 85% of infants born exposed to opioids go home with~     their mothers, and the remainder receive substitute care, either with other family members or~     via foster care.~      This investigation is a randomized controlled trial of RESPECT-Plus, a continuum of promising~     and evidence-based practices designed to strengthen family protective factors and improve~     health permanency and well-being outcomes for children born to mothers in treatment for~     opioid use disorder. Anticipated outcomes of the intervention include fewer reports of~     supported child abuse or neglect filings in the child's first year of life, fewer days in~     out-of-home placement; fewer terminations of parental rights in the child's first year of~     life; and improvements in family functions overall (e.g. improved access to basic~     needs/social determinants of health, improved parental resilience, and decreased maternal~     depression).~   "
94203|NCT02334098|"~     The objectives of this project are as follows:~        1. To assess whether omega-3 dietary supplementation for six months can reduce~          externalizing behavior problems (antisocial and aggressive behavior) in schoolchildren~          aged 8 to 18, both at the end of treatment and six months post-treatment~        2. To assess whether omega-3 supplementation can enhance cognitive and brain functioning as~          measured both by neurocognitive and psychophysiological measures~        3. To assess whether any improvements in cognitive and brain functioning can help account~          for any improvements in behavior.~   "
94204|NCT02334085|"~     The HOW Study is a first-of-its-kind international online study for women and men with and~     without a history of breast cancer. The investigators will collect information about your~     health, your job, your diet, and your family history, among other topics that can help us get~     a better understanding of breast cancer and its potential causes. Periodically, the~     investigators will send you questionnaires about anything and everything. All you have to do~     is fill them out online. It's that simple. This is a partnership and the investigators need~     you for the long haul. The more questionnaires you fill out, the more information the~     investigators will have that can help us have a better understanding of why women get breast~     cancer.~   "
94205|NCT02334072|"~     Even though the effects of anesthetic agents both inhalation and intravenous have been well~     described, the effect of laryngeal mask airways haven't. The purpose of the study is to~     determine the effects of different types of laryngeal mask airways on middle ear pressure.~   "
94206|NCT02334059|"~     Opioid sparing anesthesia is extremely important in the post-operative obese population. With~     more and more obese patients entering the operating room a multi-modal approach to analgesia~     is crucial. Finding effective alternatives to opioid therapy is the rationale of this~     proposal. Literature involving ketamine and magnesium in bariatric surgical patients is very~     sparse.~   "
94207|NCT02334046|"~     Elderly patients show different pharmacokinetic and pharmacodynamic variables and usually~     need smaller doses of anaesthetic drugs than younger patients. The purpose of this study was~     to investigate the optimal effect-site concentration of remifentanil for preventing cough~     during emergence in elderly patients under sevoflurane and remifentanil anesthesia.~   "
94208|NCT02334033|"~     Hypertension is an underdiagnosed and undertreated disease in real-life. Blood pressure and~     kidney functions are known to be closely related. Increased serum level of Cystatin C, a~     sensitive biomarker for renal function, seems to predict adverse cardiovascular events. The~     investigators aimed to evaluate the predictive value of serum Cystatin C for control of~     hypertension in a community-based study.~   "
94209|NCT02334020|"~     The purpose of the study is evaluate the effect of the Mental Health First-aid training~     course on a Danish population of employees.~   "
94210|NCT02334007|"~     After any surgery, there is a risk of venous thromboembolism (VTE), including Deep Vein~     Thrombosis (DVT) in the major veins of the legs and Pulmonary Embolus (PE) in the lungs.~     These clots are usually prevented by the administration of low-molecular-weight heparin, a~     blood thinner that prevents clotting. In most surgical specialties like thoracic or vascular~     surgery, this treatment is used until patients are discharged from the hospital. However, in~     orthopaedic surgery, there is strong evidence that longer term preventative treatment up to~     35 days after hospital discharge helps to reduce VTE occurrences. In thoracic surgery, there~     is an even greater risk of developing PE because of the surgical stress, the common presence~     of cancer and direct damage to blood vessels in the lung during surgery. Despite the~     potential utility, the use of extended VTE prevention has never been evaluated in the~     thoracic surgery population. If extended treatment prevents clots, more patients will avoid~     complications related to VTE. There is currently very limited information available on the~     incidence of venous thromboembolism (VTE) in patients undergoing lung cancer resection and~     the utility of extended thromboprophylaxis (ET) in this patient population. Furthermore, in~     contrast to patients undergoing orthopaedic surgery where ET has become standard of care,~     duration of thromboprophylaxis is not well defined in this patient population. Therefore,~     there is a clear need to systematically evaluate the effects of extended VTE prophylaxis on~     the incidence of VTE in the post-op population.~   "
94211|NCT02333994|"~     The aim of the study was to evaluate the Efficacy of Education With Balance Exercise in~     Reducing Fear of Falls in Elderly Population . In the present study the educational program~     along with balance training was delivered to group A, (Experimental group) and only Balance~     training was delivered to group B, (Control group) for 6 weeks for 1 hr duration once weekly.~     Education program included education about the risk factors of falls such as environmental~     hazards, importance of good nutrition, use of stick while walking, avoiding slippery~     surfaces. Balance training consists of stance activities and balance exercise program. The~     outcome measures for this intervention were Activities specific balance confidence scale and~     berg balance scale.~   "
94212|NCT02333981|"~     This study was formulated to determine the efficacy of passive oral motor regimen for~     drooling in children with multiple disabilities. Seven subjects aged 7-19yrs were taken in~     the study. All the subjects received passive treatment which included light touch, stroking,~     vibration, tapping, pressure and stretch. All the techniques have been proved to be effective~     in treating drooling. Relative sterility and hygiene was maintained throughout the procedure~     as sterilized gloves and napkins were used. The measurement protocol was designed to check~     effectiveness on drooling in children. The protocol was given for 4 weeks with treatment~     sessions given 3 times per week and the treatment duration was 30min. Twelve sessions of oral~     motor stimulation therapy given during the 4 weeks. Thirteen after 4 weeks of treatment,~     improvement was found in terms of the severity as well. Primary outcome measure taken was~     Drooling Frequency and Severity rating scale and secondary outcome measure being taken was~     drool quotient. Pre and post intervention scores of Drooling Frequency and Severity rating~     scale and drool quotient were taken and data was analyzed using wilcoxon signed rank test .~   "
94239|NCT02333630|"~     The investigators aim to study the clinical efficacy of a mobile health application,~     AsthmaCare, and it's impact on long term health outcomes for asthma. AsthmaCare is a novel~     application developed by members of the study team that was previously studied in a pilot~     study of 21 children/teenagers 9-16 years old. During the 30 day pilot study, there was~     universal usage and acceptance by all participants of this novel form of technology and~     asthma management. This current study aims to measure clinical outcomes for users of the app.~   "
94213|NCT02333968|"~     Pain is a prevalent and distressing symptom in patients with cancer, having an enormous~     impact on functioning and quality of life. Integration of patient self-management and~     professional care by means of care technology provides new opportunities in the outpatient~     setting. In this project a technology based and nurse delivered multicomponent~     self-management support intervention has been developed. Important components include~     monitoring, feedback, education, and nurse support. Following feasibility evaluation, the~     primary aim of this randomized controlled trial is to assess the effect of the intervention~     regarding pain intensity and quality of life as compared to care as usual. Secondary outcomes~     of the effect evaluation are self-efficacy, knowledge, anxiety and depression, and pain~     medication use. Besides, a cost-evaluation and summative process evaluation will be~     performed.~   "
94214|NCT02333955|"~     The primary objective of this study is to determine the safety and tolerability of extended~     dosing with a fixed dose of GCS-100 3 mg IV push in patients with Chronic Kidney Disease~     (CKD).~   "
94215|NCT02333942|"~     This study is being performed to generate data regarding brain vibration /oscillation~     differences between individuals with dementia and normal controls. The purpose of this study~     is to compare signal patterns generated from the impact on the scalp from these brain~     oscillation patterns from individuals with Alzheimer's disease, Frontotemporal Lobar~     Degeneration, Mild Cognitive Impairment and Age-Matched Normal Controls.~   "
94216|NCT02333929|"~     The objective of the study is to demonstrate the performances of the STA® - Rivaroxaban~     Calibrator and STA® - Rivaroxaban Control in combination with the STA® - Liquid Anti-Xa to~     determine the quantity of rivaroxaban in plasma samples by measurement of its direct anti-Xa~     activity.~   "
94217|NCT02333916|"~     Rationale: Body weight is not well regulated in all individuals. In an obesogenic~     environment, where overeating is common, some individuals are more prone to weight gain and~     therefore overweight than others. Yet, the reasons behind this are unclear. Resistant~     individuals often have higher physical activity levels (PALs). It seems that - at higher~     levels of physical activity and therefore energy expenditure - satiety signals are more~     precisely regulated, making one better at matching energy intake with expenditure. In other~     words, active people may not overeat where sedentary people would. However, this does not~     explain the differences in weight gain observed when subjects all have to overeat (imposed~     overfeeding). It could be that active people are better able to cope metabolically with the~     extra calories because of already higher levels of carbohydrate and fat oxidation compared to~     their inactive counterparts.~      Objectives: 1/ To study the effects of overfeeding (normal diet composition) on substrate~     balance and oxidation and more specifically fat balance and oxidation; 2/ to study the~     effects of exercise and training on fat oxidation during overfeeding (normal diet~     composition).~      Study design: This controlled intervention study will follow a cross-over design. Each~     subject will spend 5 nights and 4 days in a respiration chamber on two occasions, separated~     by a 10-week training period.~   "
94218|NCT02333903|"~     This study compares the ratio of lean mass losses over total body mass losses between~     patients undergoing sleeve gastrectomy followed by physical activity training versus patients~     undergoing sleeve gastrectomy only~   "
94219|NCT02333890|"~     Chloroquine (CQ) is a well known, well tolerated medication that has been used for many years~     traditionally for arthritis, lupus, and malaria. It has anti-inflammatory properties but is~     often the drug of choice for arthritis and malaria due to its few side effects. Recently,~     laboratory investigations have proven that CQ may potentially have anti-cancer properties, by~     inhibiting a process which allows cancers such as breast cancer to continue to grow (a~     process known as autophagy). Therefore, this study will look at how well CQ can inhibit the~     growth of breast cancers in patients while waiting for surgery.~   "
94220|NCT02333877|"~     The purpose of this study is to determine whether suture using the Device of Leukosan~     Skinlink is more faster and safer than that of nylon in the treatment of simple wound for~     ED patients.~   "
94221|NCT02333864|"~     The purpose of this study is to determine if the POGO® system delivers accurate blood glucose~     readings in the hands of the lay user and assess the POGO® system accuracy when used by~     trained health care professionals.~   "
94222|NCT02333851|"~     Pilot study to compare the efficacy and safety of a premixed-insulin regimen (70%~     intermediate insulin and 30% regular insulin) to a basal-bolus insulin regimen (glargine once~     daily and glulisine before meals) hospitalized patients with type 2 diabetes.~   "
94223|NCT02333838|"~     Allogeneic cord blood stem cell transplantation is a potentially curative therapy for~     patients with haematological malignancies. We have extensive experience with the use of Cord~     Blood Transplantation (CBT) in patients with advanced myeloid malignancies. In adults~     however, the 40% Non-Relapse Mortality (NRM) rate observed after CBT conditioned with a~     myeloablative conditioning has encouraged the development of CBT with Reduced Intensity~     Conditioning (RIC). Our previous national CBT protocol (the Minicord French protocol -~     NCT00797758) showed that RIC CBT can reduce NRM, but relapse remains the main post-transplant~     event (>30% at one year). Thus, the development of reduced toxicity rather than RIC~     conditioning for CBT is warranted in order to improve the outcome of such transplants by~     limiting NRM and reducing relapse rate. The Fludarabine, ATG and intensified doses of IV~     Busulfan (9.6 mg/Kg total dose) regimen is a well-established preparative regimen for~     reduced-intensity/toxicity conditioning prior to allogeneic stem cell transplantation using~     peripheral blood stem cells mobilized with G-CSF (ClinicalTrials.gov Identifier:~     NCT00841724). However, such regimen is likely not sufficient to allow for CB cell~     engraftment. Thiotepa is an alkylating and radio-mimetic agent with a large anti-tumor~     activity including leukemic cells, the ability to cross the blood-brain barrier and to~     improve engraftment of hematopoietic stem cells. This drug has been combined to usual~     conditioning regimen without increasing the toxicity but improving the engraftment rate and~     potentially reducing the relapse rate. Thus, in the context of adult CBT for high risk~     myeloid malignancies, we propose to prospectively evaluate a reduced toxicity conditioning~     based on the association of Thiotepa, Fludarabine, IV Busulfan and ATG with the objective to~     achieve acceptable NRM rates, and to allow for improved anti-leukemic control based on the~     cytotoxic component of the conditioning regimen itself, while waiting for the long term~     immune-mediated disease control (GVL effect).~   "
94224|NCT02333825|"~     This is a multi-center, randomized controlled clinical trial, the purpose of which is to~     determine if patients age 25 and younger who undergo medial patellofemoral ligament (MPFL)~     reconstruction have lower rates of recurrent instability compared to those treated~     non-operatively. The MPFL is a ligament that stabilizes the kneecap, and maintains its proper~     position in the groove on the femur (thighbone). Instability refers to a situation in which~     the kneecap moves out of place, or dislocates. When instability is recurrent, it occurs more~     than once in the same knee.~   "
94991|NCT02323789|"~     To assess whether intravenously administered third-party bone marrow-derived mesenchymal~     stromal cells (MSCs) are safe and have an impact on disease severity in RDEB~   "
94225|NCT02333812|"~     Head and neck cancers usually occur in patients who have a history of long tobacco use.~     Chronic obstructive pulmonary disease (COPD) is a chronic progressive disease of the airways~     and lung parenchyma that is also associated with exposure to tobacco. COPD and head & neck~     cancer share a common environmental risk factor in cigarette smoke exposure. the~     investigators hypothesize that patients with chronic lung disease related to smoking have a~     higher risk to develop cancer in the head and neck.~      The investigators designed a study to assess the prevalence of cancer and pre-cancer disease~     in the head & neck in patients with chronic lung disease. the investigators will examine~     patients with and without a history of smoking and chronic lung disease in order to determine~     the prevalence of head and neck cancer in the different groups. The patients who will be~     included in the study will undergo comprehensive evaluation of their lung function and voice~     performance.~      This study is a joint effort of the Pulmonology Institute and the Department of~     Otolaryngology, Head & Neck Surgery in Israel and the Netherlands.~   "
94226|NCT02333799|"~     The purpose of this study is to evaluate the efficacy, safety, tolerability and~     pharmacokinetics of bedaquiline plus PA-824 plus linezolid after 6 months of treatment~     (option for 9 months for subjects who remain culture positive at month 4) in Subjects with~     either pulmonary extensively drug resistant tuberculosis (XDR-TB), treatment intolerant or~     non-responsive multi-drug resistant tuberculosis (MDR-TB).~   "
94227|NCT02333786|"~     Investigators designed a prospective randomized controlled study to compare the~     long-axis/in-plane and short-axis/out-of-plane methods during the ultrasound-guided arterial~     catheterization in pediatric patients younger than 5 years old.~   "
94228|NCT02333773|"~     The purpose of this study is to evaluate the safety and efficacy of irreversible~     electroporation (IRE) for unresectable Portal venous tumor emboli.~   "
94229|NCT02333760|"~     An open follow up study of patients enrolled in the Phase 1/2 clinical trial of~     haematopoietic stem cell gene therapy for the Wiskott-Aldrich Syndrome and treated with~     autologous CD34+ cells transduced with the w1.6_hWASP_WPRE (VSVg) lentiviral vector.~   "
94230|NCT02333747|"~     The effect of transcutaneous electric acupoint stimulation (TEAS) on the quality of recovery~     in patients undergoing thyroidectomy surgery remains unclear. Therefore, the investigators~     conducted this prospective, randomized, double-blind study to verify the hypothesis that~     pre-operative TEAS could improve the quality of recovery (QoR) after thyroidectomy surgery.~   "
94231|NCT02333734|"~     The overall objective of this study is to examine the blood flow in the thigh muscles and~     sugar metabolism before and after 8 weeks of high intensity interval training (HIIT) on a~     bicycle ergometer in patients with type 2 diabetes (T2D) and matched controls. The following~     parameters are included in the assessment:~        -  Sugar Metabolism~        -  Muscle and fat mass~        -  The blood flow at rest around the thigh muscles~        -  Oxygen uptake test on a bicycle ergometer and 5 km time trial~   "
94232|NCT02333721|"~     The purpose of this study is to explore the short-term, long-term and oncological outcomes of~     laparoscopic spleen-preserving No. 10 lymph node dissection in a left-sided approach for~     advanced middle or upper third gastric cancer.~   "
94233|NCT02333708|"~     To demonstrate that microparticles (MPs), having a powerful procoagulant potential, are in~     larger amounts in the blood of patients with histologically proven giant cell arteritis~     (GCA), compared with patients matched for age, sex and with or without inflammatory syndrome.~   "
94234|NCT02333695|"~     A medical device for magnetic therapy for spinal cord injuries (SCI) will be disclosed. The~     apparatus comprises a combination of several magnets enclosed in a supportive cover. The~     magnets are placed in a proper position and their polarity can be changed at any time without~     any difficulty.~   "
94235|NCT02333682|"~     The investigators are intending to perform a clinical study in healthy subjects on the~     pharmacokinetics of different doses of Hy.D Calcifediol compared to vitamin D3~     (cholecalciferol) in order to gain insight into the dose response relationship and to assess~     kinetic differences including the steady state. The metabolites 1,25(OH)2D, 24,25(OH)2D will~     be assessed throughout the study to assess the metabolism of vitamin D vs. 25(OH)D. Vitamin~     D3 will be measured throughout the study to assess compliance with the restriction of~     exogenous vitamin D supplementation.~   "
94236|NCT02333669|"~     Lung fluid absorption disorders are largely mediated by transepithelial Na+ reabsorption~     through alpha epithelial sodium channels (α-ENaCs) in alveolar epithelial cells. Increasing~     evidence has demonstrated that these lung disorders might be an important cause of neonatal~     respiratory distress syndrome (NRDS) by influencing gas exchange or surfactant function,~     particularly in near-term and term infants. The SCNN1A gene, which encodes the α-ENaC, might~     predispose infants to NRDS. To explore whether the single-nucleotide polymorphisms (SNPs) of~     SCNN1A are associated with NRDS, we conducted a case-control study to investigate the~     NRDS-associated loci in Han Chinese infants. Seven target SNPs were selected from the SCNN1A~     gene and were genotyped using the improved multiplex ligase detection reaction (iMLDR).~   "
94237|NCT02333656|"~     Previous research has shown that the osteoarthritis care for persons with hip or knee~     osteoarthritis in Norway has a potential for improvement as the provided care may not~     necessarily reflect evidence-based guideline recommendations. This study will determine if a~     new model for integrated osteoarthritis (OA) care in primary health care will result in~     improved quality of osteoarthritis care and health benefits for the patients (reduced pain~     and body weight, increased function and activity level) among patients with hip and/or knee~     osteoarthritis. Further, this study will examine if the new model reduce the number of~     unnecessary referrals to Magnetic Resonance Imaging (MRI) and to orthopaedic surgeons in~     secondary care, and if it increases the number of referrals to physiotherapy treatment and~     the number of discharge reports from the physiotherapists to the referring general~     practitioner.~   "
94238|NCT02333643|"~     A phase 2, randomized, vehicle-controlled, double-blind study to assess the efficacy, safety~     and pharmacodynamics (PD) of topically applied CLS003 in otherwise healthy patients with~     cutaneous warts.~   "
94297|NCT02332876|"~     Many cancer survivor experience treatment-related impairments in mental abilities such as~     memory, attention, and concentration (known as cognition). Research indicates that physical~     activity can improve cognition in healthy adults; however, little is known about whether~     physical activity can improve cognition among cancer survivors. This study will test whether~     a physical activity intervention results in improvements in cognition among breast cancer~     survivors, which may lead to interventions to improve cognition.~   "
94240|NCT02333617|"~     This is a blinded randomized controlled trial to assess the effectiveness of manual therapy~     to improve hip abduction strength in patients with acute anterior knee pain.~      The primary objective of this study is to see if manual therapy to the gluteus medius can~     significantly alter within-session measurements of hip abductor strength in patients with~     anterior knee pain.~      The secondary objective of this study is to see if manual therapy to the gluteus medius can~     significantly alter within session pain in patients with anterior knee pain.~   "
94241|NCT02333604|"~     The Cancer Experience Registry®: An Online Initiative to Understand the Experiences of Those~     Impacted By a Cancer Diagnosis.The Registry is a web-based platform to distribute~     cross-sectional and longitudinal surveys. Study surveys are designed based on input from~     advisor experts, including patients and caregivers, and focus on the social, emotional,~     physical, financial and decision-making experiences of those who have been diagnosed with~     cancer and their caregivers. Findings contribute toward enhancing care for patients,~     survivors and caregivers via programming and policy initiatives.~   "
94242|NCT02333591|"~     GLP-1 is an agent for treatment of type 2 diabetes and may have protective effects on the~     cardiovascular system. The mechanism is complex and there seems to be a dual function with~     intact GLP-1 (7-36), acting through the GLP-1 receptor, and the GLP-1 (9-36) metabolite~     acting independently of the GLP-1 receptor.~      Coronary flow reserve (CFR) is the ratio of flow through the coronary arteries during stress~     to during rest and it reflects coronary microcirculation. Impaired CFR is a strong predictor~     of poor prognosis of cardiovascular disease.~      The aim of the study is to investigate the acute effects of GLP-1 on coronary~     microcirculation and endothelial function in adults with obesity.~   "
94243|NCT02333578|"~     A Phase I/II Pilot Clinical Trial to Evaluate the Efficacy and Safety of Ebola Virus Disease~     (EVD) Convalescent Plasma (ECP) for treatment of EVD.~   "
94244|NCT02333565|"~     To determine if combination of everolimus and octreotide exert an anti-tumoral activity in~     recurrent and/or aggressive meningiomas growth with limited adverse effects.~   "
94245|NCT02333552|"~     Frailty is a dynamic process from fit (robust) and pre-frail elderly. There is no previous~     study that determine the risk factors from fit to pre-frailty and pre-frailty to frailty in~     Indonesian elderly.~      This study was aimed to define the risk factors of frailty transitional status and its~     correlation with quality of life in Indonesian elderly outpatients.~   "
94246|NCT02333539|"~     The overall objective of this study is to address the critical need of improving insulin pump~     adherence in adolescents with Type 1 Diabetes (T1D) by providing personalized intervention~     using evidence-based techniques during routine diabetes clinic visits at point of care.~   "
94247|NCT02333526|"~     The aim of the study is to evaluate the soluble biomarker syndecan-1 (sSdc1) taken from~     venous blood of patients with infectious intestinal diseases such as Clostridium~     difficile-associated colitis, bacterial colitis, Norovirus enteritis and Crohn´s disease or~     ulcerative colitis. The level of sSdc1 will be compared with disease activity in patients~     with active inflammation and with disease in remission. Secondary objectives were the~     assessment of correlation of the above-mentioned factors with the CRP value. Subjects will be~     volunteers. Blood will be taken as part of the routine clinical work-up after the written~     agreement blood and sSdc1-level will be assessed using a human-specific sSdc1 ELISA assay. In~     addition, the subjects are asked to answer a short questionnaire. The study is designed as a~     prospective, comparative cohort study.~   "
94248|NCT02333513|"~     This trial is aimed at evaluating the safety and effectiveness of PCV chemotherapy in~     patients with recurrent high-grade glioma with IDH1/2 mutation.~   "
94249|NCT02333500|"~     This prospective pilot study will compare adolescents with restrictive anorexia nervosa who~     participated for 3 months at olfactory workshops, patients who did not, and healthy~     patients.The groups will be evaluated before the workshops and after three months, with the~     wanting score after olfactory stimuli and with serum oxytocin level.~   "
94250|NCT02333487|"~     The purpose of this PET study is to verify the binding of Lu AF35700 after multiple oral~     dosing at the dopamine and the serotonin receptors in male patients with schizophrenia.~   "
94251|NCT02333474|"~     The purpose of this study is to evaluate the safeness and effectiveness of mix vaccine (MV).~     Enrolled patients will receive standard treatment according to National Comprehensive Cancer~     Network (NCCN) guide line with or without combining MV injection. The efficacy and side~     effect will be compared between the two groups.~   "
94252|NCT02333461|"~     Excess caloric consumption, particularly from inexpensive, energy dense foods that are high~     in fat and refined carbohydrates, is a major driver of the global obesity epidemic. Dietary~     supplements that promote reduced intake of energy dense foods and/or impact the absorption~     and metabolism of fat and carbohydrates in the body can be used to help consumers control~     their weight. We identified two separate mechanistic approaches to target these effects.~      Diacylglycerol acyltransferase-1 (DGAT-1) is an enzyme involved in the formation of dietary~     fat into circulating triglycerides within the body. Once dietary fat is digested and~     absorbed, the resulting fatty acids are re-esterified into triglycerides. Inhibition of~     DGAT-1 results in delayed and decreased re-esterification of dietary fats into circulating~     triglycerides. It is hypothesized that this effect may lead to decreased deposition of excess~     dietary fat as adipose tissue, possibly due to increased fatty acid oxidation in the~     enterocytes.~      Ghrelin is a hormone that is known to stimulate appetite in humans. When calorie dense fatty~     foods are sensed in the stomach, ghrelin is acylated and activated via ghrelin~     O-acyltransferase (GOAT). The activation step attaches a medium chain fatty acid to the~     ghrelin molecule that enables it to transmit a signal in the brain that triggers eating and~     fat storage in adipose tissue. Interfering with the GOAT pathway will inhibit ghrelin~     activation and possibly diminish food intake and lipid storage. This concept is supported by~     animal studies in which weight gain in a high fat diet model is prevented when GOAT is~     inhibited.~      Our objective was to determine whether botanicals demonstrating in vitro DGAT-1 and GOAT~     inhibition have similar mechanistic effects in the human body. Based on the results of this~     study, prototype formulas may be developed and clinically- tested for outcomes related to~     weight management.~   "
94253|NCT02333448|"~     The study consists in taking 4 tubes of blood at different times over a period of 10 days,~     via a catheter (central venous or arterial catheter) already in place in the usual~     therapeutic management. These samples will make it possible to measure blood levels of~     certain markers specific to invasive candidiasis. PCR will be used to quantify fungal load~     precisely, that is to say the quantity of yeast present in the blood and to monitor this~     quantity over time.~      These samples will be transferred to a specialized unit and stored for a maximum of three~     years for use at the end of the study.~   "
94992|NCT02323776|"~     The purpose of this study is to identify features of the cumulative dose-volume histogram~     (DVH) for patients treated with trimodality therapy in oesophageal cancer and correlate these~     with postoperative complications.~   "
94254|NCT02333435|"~     Prostate cancer, the most frequently diagnosed cancer among occidental men, is associated~     with a major individual and societal burden. Although still controversial, the literature~     suggests that a high consumption of omega-3 fatty acids (ω3) has protective effects against~     prostate cancer. One of the proposed mechanisms of action of ω3 lies in their~     anti-inflammatory properties. In addition, there are some observational evidences suggesting~     an association of ω3 intake with a lower rate of depression in cancer patients. However, no~     clinical study has tested the efficacy of ω3 supplementation on psychological and quality of~     life outcomes in that population. Several evidences point to a possible involvement of~     inflammation in psychological issues. Reducing the systemic inflammatory state may have~     beneficial impact on the quality of life of these patients. Preliminary work from this team~     of investigators, in a cohort of patients managed with active surveillance for their~     low-grade prostate cancer, show a strong inverse association between the risk of prostate~     cancer progression (to high-grade) and the level of prostatic eicosapentanoic acid (EPA- a~     type of ω3).~      HYPOTHESIS: EPA-rich monoglycerides fish oil (MAG-EPA) has global positive effects on~     prostate cancer cell proliferation, inflammation and on the patient's psychosocial~     functioning and quality of life.~      The investigators propose a double blind, randomized controlled clinical trial. 130~     consecutive patients suffering from high-risk prostate cancer who choose to be treated by~     radical prostatectomy will be eligible to this study. The presence of high-grade cancer will~     be mandatory.~      The intervention, a daily supplementation with 3g supplement of fish oil monoglycerides rich~     in EPA, vs. placebo capsules containing high oleic sunflower oil, will start six weeks before~     the prostatectomy and will continue for one year after surgery. The potential confounding~     variables will be measured before the start of the intervention: age, anthropometric~     parameters, stage and clinical and pathological tumor grade (Gleason score), pre-operative~     level of prostate specific antigen and diet.~      This project proposes a simple intervention by dietary supplementation that could eventually~     help to reduce the incidence and/or progression of prostate cancer, and the consequences of~     its treatment, and thus could contribute to diminish the heavy individual and societal burden~     of prostate cancer. The clinical data generated by this trial will serve as solid basis for a~     large-scale phase III clinical trial.~   "
94255|NCT02333422|"~     The investigators therefore propose a pilot study to establish the effectiveness of NIRS~     Neurofeedback training in reducing the intensity of ADHD symptom expression on children,~     improvement of the cognitive and global functions associated with ADHD, effects on cerebral~     blood perfusion in the cortex and safety plus possible unknown side-effects.~   "
94256|NCT02333409|"~     Pancreatic cancer is the sixth most common cause of cancer death in Hong Kong. Patients~     suffering from pancreatic cancer are associated with a poor prognosis and survival of less~     than one year is expected in inoperable tumours (1). Management of these patients would be~     towards palliation of symptoms. Severe pain occurs in 50 to 70% of the patients and this~     intractable pain is often difficult to treat (2). Pain management is a major part of the~     comprehensive therapy in patients with pancreatic cancer, and it also affects their quality~     of life. Electroacupuncture seems to be a promising way to control the cancer pain and reduce~     the dose and side effects of pain killers including opioid. This study aimed to investigate~     the efficacy and safety of electroacupuncture in reducing pancreatic cancer pain in patients~     suffering from inoperable pancreatic cancer.~   "
94257|NCT02333396|"~     The project seeks to study the use of an navigator-based intervention called PICU Supports.~     The study will test the impact of PICU Supports during and after PICU discharge on parent~     outcomes (satisfaction with decision making, decision regret, anxiety, depression,~     post-traumatic stress, health-related quality of life, and complicated bereavement) and on~     parent and healthcare team member assessments of communication and team collaboration.~   "
94258|NCT02333383|"~     This is a prospective mono-country, multi-center study in Ankylosing Spondylitis (AS)~     subjects treated with Adalimumab. At least 200 subjects will be enrolled at approximately 10~     sites. The baseline assessment should be performed prior to the first dose of Adalimumab.~     Study visit will be conducted at 12, 28, 36 and 52 week after baseline. All subjects will~     have one follow-up approximately 70 days after last dose of Adalimumab.~   "
94259|NCT02333370|"~     The purpose of the Phase Ib is to:~        1. determine the recommended dose of LEE011 in combination with a standard dose of~          letrozole as well as to provide additional safety and anti-tumor activity data in Asian~          non-Japanese patients~        2. determine the recommended dose of LEE011 in combination with a standard dose of~          letrozole as well as to provide additional safety and activity data in Japanese patients~        3. evaluate the safety and anti-tumor activity of LEE011 at the RP2D established in the~          dose escalation part in combination with a standard dose of letrozole, fulvestrant or~          tamoxifen plus goserelin in Japanese patients.~   "
94260|NCT02333357|"~     This study is developing and testing a 12-step toolkit with five modules, training counselors~     to use them, and studying their frequency of use, desirability, effectiveness and patient~     outcomes. The toolkit includes counselor written guides, posters, client worksheets,~     engagement activities, and videos designed to be shown during substance abuse treatment group~     sessions to explain and encourage 12-step participation.~   "
94261|NCT02333344|"~     It's to investigate the efficacy of Zoledronic acid treatment on the early prosthetic~     fixation in post-menopausal osteoporosis women under cementless total hip arthroplasty after~     24-month observation.~   "
94262|NCT02333331|"~     The purpose of this study is to determine the efficacy of repeat dosing with multiple dose~     levels of bimagrumab on patient physical function, skeletal muscle mass and strength in older~     adults with sarcopenia. In addition, this study will generate data on the safety,~     tolerability, and pharmacokinetics of bimagrumab in older adults with sarcopenia.~   "
94263|NCT02333318|"~     The objective of this study is to investigate the safety, tolerability and pharmacokinetics~     (PK) of VVZ-149 injection after a single dose or loading/maintenance dose in healthy older~     male volunteers.~   "
94264|NCT02333305|"~     We propose a study on Ataxia with oculomotor apraxia type 1 (AOA1) in which Coenzyme Q10~     (CoQ10) deficit has been observed. Main objectives of the study are :~        -  To monitor evolution of albumin in patients affected with AOA1 while supplemented with~          CoQ10 ;~        -  To measure with clinical scales and biological markers efficacy of supplementation on~          disease evolution.~      AOA1 is characterised by Hypoalbuminemia. Disease duration is negatively correlated with~     albumin level. This study aims to understand mechanisms of the disease and our hypothesis is~     that correction or stabilization of albumin level with CoQ10 supplementation could impact~     disease evolution. The study is planned from 1 to 2 years supplementation. The CoQ10 is~     classified as a food supplement and has already been tested in other neurological conditions.~   "
94317|NCT02332616|"~     This study evaluates the pathophysiological effects of a single dose of methylprednisolone~     administered prior to total knee-arthroplasty surgery. The investigators examine the effect~     on complement activation.~      Half of participants will receive intravenous Solu-Medrol 125 mg, while the other half will~     receive placebo.~      The investigators hypothesize that the group receiving methylprednisolone will experience~     beneficial inhibition of the undesirable parts of the complement activation.~   "
94265|NCT02333292|"~     Objectives: 1) To evaluate la proportion of hepatitic C virus (HCV)-monoinfected patients who~     show sustained virologic response (SVR) to treatment including direct-acting antivirals~     (DAAs) in the clinical practice in clinical units that treat infectious diseases and 2) to~     determine the frequency of adverse events, including those that are severe and/or cause~     treatment interruption, in DAA-based therapy in this setting.~      Design: Multicentric, prospective post-authorised cohort study. Setting: Hospitals of the~     Hepatitis Study Group (GEHEP) of the Spanish Society of Infectious Diseases and Microbiology~     (SEIMC).~      Study population: HCV-monoinfected patients that initiate DAA-based treatment outside~     clinical trials.~      Variables: The primary efficacy outcome variable is the proportion of patients who reach~     undetectable HCV-RNA 12 weeks after the scheduled end of therapy (SVR12). The primary safety~     outcome variable is the percentage of subjects who discontinue therapy due to adverse events.~      Statistical analysis: A descriptive study will be performed, as well as a double sensibility~     analysis of the frequency of SVR12 using both an intention-to-treat and an on-treatment~     approach. Those variables that are associated with SVR12 with a p-value <0.2 will be included~     in a logistic regression analysis in which SVR12 will be the dependent variable.~   "
94266|NCT02333279|"~     The investigators will determine the cancer risk in organ transplant recipients compared to~     the general population with the help of statistical analysis. Secondly the investigators will~     try to characterize the different cancer types.~   "
94267|NCT02333266|"~     The purpose of this study is to determine whether the newly developed biosensor can be used~     to detect and quantify fungal cells in human blood samples.~   "
94268|NCT02333253|"~     40 patients attending IVF center during 2013 &2014 were fulfilling criteria of poor response~     and they failed to go through OPU as they gave <3 mature follicles on a dose of 300U GN or~     more. All patients were revised for history, examinations and investigations, including age,~     type and duration of infertility, day 3 FSH, Day 3 E2, AMH, AFC.~   "
94269|NCT02333240|"~     New-onset raised blood pressure (BP) affects about one in ten pregnancies. For some women,~     raised BP is an indication of pre-eclampsia: newly arising high blood pressure in pregnancy~     combined with protein leaking into the urine. After birth, women's BP remains elevated for a~     period of time, but in most cases returns to normal over 2-12 weeks. During this period~     medication needs to be adjusted to achieve the correct control. Research suggests that better~     BP control during this period is associated with improved long-term health outcomes. The~     investigators would like to find out whether home BP monitoring, and self-adjustment of~     medications according to an individualised protocol, could improve BP control and patient~     satisfaction.~      This pilot study has been set up to inform the planning of a large-scale multi-centre~     randomised controlled trial by testing the feasibility of the protocol. The investigators~     want to increase our experience of applying this management approach in this subset of~     patients; to select the most appropriate primary outcome measure and to estimate the effect~     size of this intervention; to assess recruitment potential; and to evaluate feasibility of~     coordinating this trial across several centres. The primary objective of the large-scale~     trial will be to determine whether the self-management approach can improve BP control in~     women with medicated hypertensive disorders of pregnancy in the postnatal period.~      Women recruited to the study will be randomly assigned to one of two groups: self-management~     or usual care. Participants allocated to 'usual care' will have their BP monitored and~     medication adjusted by their general practitioner (GP) and midwife as normal. Participants~     allocated to the 'self-management' group will use a home BP monitor daily following discharge~     from hospital after birth. They will be provided with an individualised schedule for~     gradually decreasing their medication(s) in line with their BP readings. Women will be~     followed up for 6 months.~   "
94270|NCT02333227|"~     The hypothesis of the investigators' project is that comprehensive primary preterm birth~     prevention, inclusive of maternal oral health with xylitol chewing gum (the intervention),~     will reduce the rate of periodontal disease and caries, preterm birth prevalence, and~     neonatal mortality.~   "
94271|NCT02333214|"~     Frailty is a highly prevalent condition, reaching approximately 7% to 30% of older adults~     aged from 65 up to 80 years [2]. Although exercises seemed to be beneficial for the frail~     elders, there is still insufficient evidence to indicate the appropriate modality, frequency~     and intensity of physical exercises that were able to improve physical functioning in this~     population [9]. The virtual reality (VR) using interactive games (exergames) have generated~     broad scientific and clinical interest in recent years[10]. Studies indicate that older~     adults can benefit from training with exergames in improving mobility [12, 13], lower limb~     strength [14], cognition, particularly executive function [13], body balance [10, 15-18],~     reaction time [12] and may contribute indirectly to prevent falls [10, 19, 20]. But, there is~     still insufficient evidence to suggest that the use of exergames are superior even to other~     types of intervention [21-23] or in combination with conventional physiotherapy [24] The~     purpose of this study is to investigate the effectiveness of adding exercises using~     interactive videogames (exergames) in improving physical functioning on frail and pre frail~     older people when compared to conventional physiotherapy. A parallel randomized clinical with~     a 6 month follow-up period will be conducted with 82 frail community dwelling older adults.~     Participants randomized to the Experimental Group will be submitted to 30 minutes of~     conventional physiotherapy and 20 minutes of therapy using interactive games Xbox 360 Video~     Game and Entertainment Microsoft System with Kinect sensor.~      The Control Group will receive 50 minutes of conventional physiotherapy. Both groups will~     receive 50 minutes of intervention twice a week for 12 weeks. Primary outcomes will be~     assessed by the Short Physical Performance Battery, the Usual walking speed test and Four~     Step Square Test in the baseline, 3 and 6 months after that.~   "
94272|NCT02333201|"~     Dysphagia significantly contributes to morbidity and mortality in non-critically ill patients~     (as e.g. in stroke). Long term consequences of dysphagia include, among others, malnutrition,~     prolonged enteral tube feeding and increased risk of aspiration. In the present observational~     analysis, the investigators aim to elucidate the incidence and the impact of dysphagia on the~     clinical course of a mixed population of ICU patients post invasive mechanical ventilation.~   "
94273|NCT02333188|"~     This phase I/II trial studies the side effects of genetic analysis-guided dosing of~     paclitaxel albumin-stabilized nanoparticle formulation, fluorouracil, leucovorin calcium, and~     irinotecan hydrochloride (FOLFIRABRAX) in treating patients with gastrointestinal cancer that~     has spread to other parts of the body and usually cannot be cured or controlled with~     treatment. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle~     formulation, fluorouracil, leucovorin calcium, and irinotecan hydrochloride, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Genetic analysis may help doctors~     determine what dose of irinotecan hydrochloride patients can tolerate.~   "
94318|NCT02332603|"~     This study evaluates the pathophysiological effects of a single dose of Methylprednisolone~     administered prior to total hip- and knee-arthroplasty surgery. The investigators examine the~     effect on blood glucose homeostasis.~      Half of participants will receive intravenous Solu-Medrol 125 mg, while the other half will~     receive placebo.~      The investigators hypothesize that the glucose homeostasis remains equally stable in the~     group receiving Methylprednisolone as in the group receiving placebo.~   "
95360|NCT02318953|"~     This study evaluate if in an ambulatory breast reconstruction patient population at Women's~     College Hospital (WCH), can we avert in-person follow-up care through the use of mobile app~     home monitoring compared to conventional, in-person follow-up care in the first 30-days~     following surgery.~   "
94274|NCT02333175|"~     The aim of this project is to evaluate the needs and provision of care for patients in the~     late stages of Parkinsonism and their carers in several European countries, to compare the~     effectiveness of different health and social care systems, and to lay the foundation for~     improved outcomes in this population. The investigators will undertake an in-depth assessment~     of patients and their care arrangements in a population recruited through networks in six~     European countries. The systems and procedures that are used in the provision of care will be~     reviewed through a systematic literature review, interviews and assessments of patients,~     carers and health care providers, and through a trial comparing assessment by a specialist~     with management suggestions, guidance and access to telephone advice to that of usual care.~     Through interviews, questionnaire assessment and review of current health-care and social~     care arrangement, the investigators will assess the needs, provision of care and use of~     health-care resources, and their impact on patient and carer outcomes in different countries.~     National and regional databases will also be interrogated to identify current practice and~     use of healthcare resources and drug usage. A systematic literature review of the evidence~     for effective management strategies, analysis of the study data, and evaluation of change in~     outcomes following specialist review will provide the basis for recommendations in the~     management of late stage Parkinsonism. The investigators will also evaluate potentially~     useful outcome measures for use in this patient group. In addition to charting the needs and~     current care provision for late stage Parkinsonism in different European countries, its cost~     and effectiveness, and an analysis of health-care and social care predictors of improved~     outcome, the project will produce a platform for the assessment of patients with late stage~     Parkinsonism, their current treatment and care provision, as well as guidelines on the~     management of this late disease phase.~   "
94275|NCT02333162|"~     This phase I trial studies the side effects and the best dose of intensity modulated total~     marrow irradiation (IMTMI) when given together with fludarabine phosphate and melphalan in~     treating patients with cancers of the blood (hematologic) that have returned after a period~     of improvement (relapsed) undergoing a second donor stem cell transplant. IMTMI is a type of~     radiation therapy to the bone marrow that may be less toxic and may also reduce the chances~     of cancer to return. Giving fludarabine phosphate, melphalan, and IMTMI before a donor stem~     cell transplant may help stop the growth of cells in the bone marrow, including normal~     blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune~     system from rejecting the donor's stem cells. When the healthy stem cells from a donor are~     infused into the patient they may help the patient's bone marrow make stem cells, red blood~     cells, white blood cells, and platelets.~   "
94276|NCT02333149|"~     This study is a multi-center, randomized, triple-blind, placebo-controlled parallel-group~     trial, in which each participant is offered an N-of-1 trial. The purpose of this study is to~     assess the efficacy and safety of melatonin (3 mg or 6 mg) compared with placebo for initial~     insomnia in children with attention-deficit disorder.~   "
94277|NCT02333136|"~     The LighTouch device shines imperceptible red light into the skin and measures the light that~     comes back out using the method of Raman Spectroscopy. Some of this light is color shifted~     and some is not. Using a proprietary numerical recipe, the LighTouch device combines the~     signals in this remitted light and calculates hematocrit, glucose, protein and potentially~     other analytes. Thus the LighTouch device produces information without painful physical~     insult to the patient and can trend changes in these blood analytes in order to predict the~     need for intervention.~   "
94278|NCT02333123|"~     This efficacy study evaluates the safety and effectiveness of aspirin for venous leg ulcer~     healing. The study also examines whether patients can be recruited to a larger study.~     Patients with chronic venous leg ulceration presenting and undergoing care in leg ulcer~     community clinics or hospital out-patient clinics, or registered with a clinic but are~     receiving care at home will be recruited. All patients will receive standard compression~     bandaging. Half of the participants will be randomised to receive aspirin, while the other~     half will receive a placebo.~   "
94279|NCT02333110|"~     Palliative radiation therapy represents 40% of the on-going radiation at the Jewish General~     Hospital. In a traditional palliative radiation treatment to bulky or radioresistant tumors,~     radiotherapy schema varies from 24 to 30 Gys given in 3 to 10 fractions, depending on the~     tumor size, tumor location and tumor pathology. However, for many patients this treatment~     involves considerable toxicity, travel and time spent at the hospital. Spatially fractionated~     radiation (SFR) is an alternative technique that consists in delivering one single treatment,~     given through a grid containing holes. The present study is proposing to validate SFR as a~     safe and effective mean to palliate patients with symptomatic bulky tumors (more than 8 cm)~     or with tumors known to be resistant to radiation.~   "
94280|NCT02333097|"~     Comparative genomic hybridization (CGH)-based microarrays are now often used during pregnancy~     in case of fetal polymalformation in order to assess significant genomic alterations.~     However, it is not clear whether array-CGH provide a diagnostic utility in case of isolated~     congenital heart defect.~      This is the first prospective study aiming at defining the right chromosomal screening when a~     fetal isolated congenital heart defect is identified by ultrasound.~   "
94281|NCT02333084|"~     This is a randomized, placebo controlled study. The first subject is expected to be enrolled~     in July 2014, and the last subject is expected to complete the study by July 2015. Each~     subject will be provided with the PRN Joint Comfort Formula, placebo or PRN Flex Omega~     Benefits® combination depending on randomization (1:1:1 at each site) during the course of~     the study. Instructions and frequency of use will be determined by the labelling.~   "
94282|NCT02333071|"~     A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an~     Open-label Extension to evaluate the efficacy of bremelanotide (BMT), administered~     subcutaneously (SC) on an as needed basis for the treatment of HSDD (with or without~     decreased arousal) in premenopausal females.~   "
94283|NCT02333058|"~     The primary goal of this study is to evaluate an alternative myeloablative, but reduced~     toxicity conditioning regimen in children, to describe the safety and efficacy of intravenous~     (i.v.) Treosulfan administered as part of a standardised Fludarabine-containing conditioning~     and to contribute to the current pharmacokinetic model to be able to finally give age (or~     body surface area) dependent dose recommendations. The treatment regimens given in the~     protocol MC-FludT.17/M are based on sufficient clinical safety and efficacy data. Considering~     the vital indication for allogeneic haematopoietic stem cell transplantation of the selected~     patient population, the risk-benefit assessment is therefore reasonably in favour of the~     study conduct.~   "
94284|NCT02333045|"~     This study seeks to understand the immune cells in the cervical fluid of in the blood and~     genital tract of HIV-negative healthy female volunteers and to see if these cells can be~     modified using a combined anti-viral and antiinflammatory drug called maraviroc, a medicine~     used in the treatment of HIV infection.~   "
94285|NCT02333032|"~     The main objective of this study is to determine if a single session of treadmill training~     with a positive slope improves the kinematic parameters of the hip, knee and ankle on the~     paretic lower limb.~      Secondarily we will quantify the efficiency of a such training on kinetic and functional~     parameters.~   "
94286|NCT02333019|"~     While the U.S. teen birth rate is currently at its lowest level, it remains high in relation~     to other industrialized countries and continues to be a public health concern due to health~     risks for teen mothers and their babies, and associated social and economic costs. Parental~     monitoring, supervision, and open communication about sexual issues have been found to be~     protective factors for adolescent sexual activity and pregnancy. Our theoretically based~     Internet program for parents of pre-adolescent children aged 10-14, Let's Talk about Sex, is~     designed to build parental communication, knowledge, and attitudes to discuss sensitive~     topics with their child, including sexuality, pregnancy prevention, and preventing sexually~     transmitted illnesses (STIs). This age group of children was selected because parental~     communication about pregnancy and STI prevention will be most effective if initiated prior~     to, rather than after, the age when children commonly become sexually active. The Let's Talk~     about Sex program is grounded in behavior change theory and incorporates the use of video~     for behavioral modeling and emotional support.~   "
94287|NCT02333006|"~     This study is conducted over 18 months. The main objective of this study is to test and~     compare the relevance and reliability of different tools for measuring the anosognosia.~      Secondary objectives are :~        -  identify the relevant test who are able to evaluate more specially the cognitive~          processes involved in anosognosia~        -  explore the links between the anosognosia manifestations and the psychological~          manifestations~   "
94288|NCT02332993|"~     The purpose of this study is to examine the changes that result in the wound healing of a~     type II Diabetic using Negative Pressure Therapy after 12 weeks of daily supplementation of~     ImmunAge (Fermented Papaya Preparation (FPP). ImmunAge (FPP) is a supplement made from Carica~     papaya Linn and is available over the counter. ImmunAge (FPP) is an investigational drug,~     which means it has not been approved by the U. S. Food and Drug Administration (FDA).~     Approximately 30 subjects will participate in this study. 15 subjects will take the~     supplementation and 15 subjects to take no supplementation as the control. The~   "
94289|NCT02332980|"~     This phase II trial studies how well pembrolizumab alone or with idelalisib or ibrutinib~     works in treating patients with chronic lymphocytic leukemia or other low-grade B-cell~     non-Hodgkin lymphomas that have returned after a period of improvement or have not responded~     to treatment. Monoclonal antibodies, such as pembrolizumab, block cancer growth in different~     ways by targeting certain cells and allow the immune system to attack the cancer. Idelalisib~     and ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for~     cell growth. Giving pembrolizumab alone or with idelalisib or ibrutinib may be an effective~     treatment in patients with chronic lymphocytic leukemia or other low-grade B-cell non-Hodgkin~     lymphomas.~   "
94290|NCT02332967|"~     The primary objective of this trial is to demonstrate that infants receiving an infant~     formula in which 40 or 50% of the palmitic acid is in the sn-2 position have, during the~     first 4 months of life, stools that are softer than those of infants receiving a control~     formula.~   "
94291|NCT02332954|"~     The purpose of the study is to describe the association/correlation between change in~     patient-reported cognitive symptoms and work productivity in gainfully employed patients~     receiving vortioxetine for a Major Depressive Episode (MDE).~   "
94292|NCT02332941|"~     The purpose of this study is to determine if treatment of Age Related Macular Degeneration~     (AMD) with a new medication,rituximab is effective. To address this issue, investigators~     propose a clinical trial in which patients with late stage disease, poor vision and who have~     failed treatment by conventional means will receive rituximab by direct injection into the~     affected eye and will be followed for improvement in the structure of their retina. Age~     Related Macular Degeneration (AMD) is a leading cause of vision loss in the elderly with~     routine care involving injections in the eye to improve and to prevent worsening of vision.~     However, some patients do not respond to the medications that we currently have and as such~     an alternative medication is needed. One potential medication is rituximab, which has been~     injected into the eye for primary eye cancer, and has been tolerated well and led to patient~     improvement. Investigators will obtain baseline eye tests then plan on injecting this~     medication in to the eye of our patients with late stage AMD, by first placing numbing drops~     into the eye, then injecting the medication directly into the eye using sterile techniques.~     Investigators will then follow the patient and repeat eye tests to monitor for improvements.~   "
94293|NCT02332928|"~     This is a double-blind, placebo-controlled trial wherein subjects with breast cancer will be~     randomized to receive either 20 mg oral melatonin or placebo the night before their first RT,~     nightly throughout their RT, and for an additional 2 weeks following the completion of their~     RT. After informed consent is obtained from eligible subjects, they will then be~     electronically randomized on a 1:1 ratio to melatonin treatment or placebo. The subjects will~     be stratified according to treatment duration (less than 3 weeks; equal to or greater than 3~     weeks) and prior chemotherapy.~   "
94294|NCT02332915|"~     A growing neurorehabilitation literature suggests that intense treatment may be desired to~     maximize the effects of therapy following neurologic injury. This investigation is designed~     to facilitate the development of efficacious, clinically applicable treatment for acquired~     apraxia of speech by examining the effects of intensity of treatment (e.g., 9 hours per week~     vs. 3 hours per week, while holding total number of sessions constant) with a group of~     speakers who have chronic apraxia of speech and aphasia.~   "
94295|NCT02332902|"~     This trial is evaluating the use of oral Everolimus to determine if there is a reduction in~     the size of the disfiguring cutaneous lesions in patients with Neurofibromatosis 1 over a 6~     month period. The evaluation will be done by 3D photography measuring volume with the LIFEVIZ~     Micro system.~   "
94296|NCT02332889|"~     The main purpose of this study is to determine the safety of using the combination of~     decitabine and a cancer vaccine plus Hiltonol. The vaccine will be made from the subject's~     blood cells and is designed to interact in the subject's body with cells that are programmed~     to fight specific tumor proteins NY-ESO-1, Melanoma Antigen Gene-A1 (MAGE-A1) and Melanoma~     Antigen Gene-A3 (MAGE-A3). The decitabine will be given to increase the amount and activity~     of these cancer proteins on the surface of tumor cells to increase the possibility that the~     vaccine will stimulate cells to act against the tumor cells. Subjects will be assessed to~     determine how these tumors respond to the treatment.~   "
94382|NCT02331771|"~     This randomized, placebo-controlled trial will evaluate the use of donepezil compared to~     placebo to reduce the risk of memory impairment after electroconvulsive therapy (ECT).~   "
94298|NCT02332863|"~     Endoscopic ultrasound (EUS) has been pivotal in accomplishing image guided radiation therapy~     (IGRT) in patients with pancreatic cancer by allowing precise contouring and identification~     of target lesions in the pancreas via placement of fiducials using fine needle aspiration~     (FNA) needles. Currently, back-loading the fiducials is the only option for preparing~     delivery of fiducials via the EUS approach. A prototype 22-Gauge EUS needle preloaded with~     four fiducials has recently been developed, and used in a porcine models with successful~     results. There are no randomized controlled trials comparing total duration of time needed~     for placement of fiducials using technical success of the traditional back- loading technique~     of fiducial markers to the new preloaded needles in regards to EUS based fiducial marker~     placement for IGRT in pancreatic cancer.~      Hypotheses~      Use of a 22 G preloaded needle for EUS guided fiducial marker placement in patients with~     pancreatic cancer will:~        1. Be delivered in at least require 60% less of the procedure time that it takes for~          traditional back-loaded 22G needles~        2. Improve overall procedure efficiency~        3. Maintain comparable technical success and adverse event rates.~      Primary Aims~      1) To compare the procedure time of 22G needle placement of three Visicoil (brand of flexible~     linear back-loaded fiducial markers) fiducial markers and 22G needle preloaded fiducial~     markers.~      Secondary Aims~        1. To compare adverse event rates in 22G needle placement of Visicoil fiducial markers and~          22G needle preloaded fiducial markers~        2. To compare endpoints of technical success defined as proper placement of two to three~          fiducial markers in a pancreatic neoplasm in 22G needle placement of Visicoil fiducial~          markers and 22G needle preloaded fiducial markers.~   "
94299|NCT02332850|"~     This study will be conducted as a standard Phase 1b, open-label, multi-center study of~     patients with relapsed and/or refractory Myeloma who have received at least two prior~     therapeutic treatments or regimens. Throughout the Phase I portion of this study, a standard~     3+3 dose escalation design will be utilized. Two dosing cohorts will evaluate escalating~     doses SAR650984 (5mg/kg and 10 mg/kg Day 1 and 15 of each 28-day cycle) with standard dose~     Carfilzomib (20-27 mg/mg2). Once a safe dose is established, an expansion cohort will further~     evaluate safety and begin to assess activity of this combination (SAR650984 (5mg/kg or 10~     mg/kg Day 1 and 15 of each 28-day cycle) with standard dose Carfilzomib).~      During the dose escalation portion of the study, the DLT period will be the first cycle (28~     days) or from Day 1 through Day 28 of initial study treatment.~      Expansion Phase Cohort An expansion cohort will begin once the MTD of SAR650984 plus standard~     dose Carfilzomib is established. The Expansion Cohort will enroll 18 patients for additional~     safety and preliminary efficacy data of SAR650984 plus Carfilzomib at the MTD.~   "
94300|NCT02332837|"~     Online trials require informed consent from participants. Massive online trials make~     face-to-face signed consent unrealistic and existing consent comprehension could be improved~     to increase participant safety and understanding.~      This trial will compare understanding of traditional digital consent with multi-media consent~     and with consent that is multi-media and interactive and uses a test and train model.~      The computer will assign participants to 1 of 3 methods to present online consent to~     participants~   "
94301|NCT02332824|"~     The primary objective of this study is to test the efficacy and safety on daily oral doses of~     TAK-272 5 mg, 20 mg, 40 mg and 80 mg in patients with type 2 diabetes mellitus and~     microalbuminuria by randomized, double-blind, placebo-controlled, parallel-group comparison~     in order to determine the clinical dose of TAK-272.~   "
94302|NCT02332811|"~     Primary Objective:~      Evaluate the reduction in serum phosphorus from baseline to end of study with Sevelamer~     carbonate tablets 800 mg and Sevelamer carbonate Powder 2.4 g in chronic kidney disease (CKD)~     patients both on haemodialysis and not on dialysis~      Secondary Objective:~      Evaluate the safety on the basis of adverse events, changes in laboratory values and vital~     signs from baseline (Day 0) to Day 56 (End of treatment/ End of Study)~   "
94303|NCT02332798|"~     This study aims to assess the safety, tolerability and pharmacokinetics of PF-04958242 in~     multiple ascending doses in subjects with stable schizophrenia.~   "
94304|NCT02332785|"~     With this study, the investigators plan to review the clinical, epidemiology, pathology, and~     endoscopic features of colon serrated lesions as well as outcome of endoscopic resection of~     these lesions. The findings will help us define the natural history of colon serrated~     lesions, develop techniques for endoscopic management of patients with serrated lesions, and~     identity areas for improvement. The data will be used for continuing quality improvement and~     presenting our outcomes at academic meetings and publishing our results in peer reviewed~     journals.~   "
94305|NCT02332772|"~     With this study, the investigators plan to review the performance of colonoscopic resection~     of large (> 1 cm) and flat lesions in the colon. The findings will help us define the role of~     colonoscopic resection of colon polyps and flat lesions and identity areas for improvement.~     The data will be used for continuing quality improvement and presenting our outcomes at~     academic meetings and publishing our results in peer reviewed journals.~   "
94306|NCT02332759|"~     The Materna device aims to prevent pelvic tissue damage by preventing overstretching of~     pelvic floor muscle fibers during delivery. The device is a single use, disposable,~     mechanical dilator that penetrates the first 4 cm or ½ of the vaginal canal and gradually~     expands the vagina from a resting diameter of 2-3 cm to the fully expanded size of a~     delivering fetus, roughly 8-10 cm. The Materna device will be used during the first stage of~     labor, for roughly 1-2 hours, in a hospital Labor and Delivery unit, under the supervision of~     trained clinical labor and delivery providers~   "
94307|NCT02332746|"~     The purpose of this study is to explore temporal relationships between self-worth and~     physical activity (PA) participation in middle-aged women (aged 35-64 years). We are~     particularly interested in the predictive role of self-worth on women's daily PA~     participation.~      This study will include two phases: a pilot phase to test the procedures and a test phase to~     assess self-worth and PA. During the test phase, Women will receive text message prompts in~     the morning, afternoon, and evening for 28 days on their cell phones. Each prompt will~     include a link to an 11-item mobile Internet-based survey assessing momentary PA, self-worth,~     and self-efficacy. Women will also concurrently wear an activity monitor (GENEActiv) to~     objectively measure their activity levels throughout the study.~   "
94308|NCT02332733|"~     The purpose of this study is to evaluate the safety of and immune response to two doses of a~     dengue vaccine (TV003) given 6 months apart to healthy adults, adolescents, and children in~     Thailand.~   "
94383|NCT02331758|"~     The purpose of this study is to explore the factors which affect ovarian response of PCOS~     patients with IVF-ET treatment, in order to provide predictive clinical index for the outcome~     of IVF-ET treatment in PCOS patients. After figuring out the controllable factors,~     researchers would be able to educate PCOS patients and improve the success rate while~     reducing the incidence of complications during the treatment at the same time.~   "
94384|NCT02331745|"~     This study evaluates the Granulocyte colony-stimulating factor (G-CSF) in the treatment of~     Acute on Chronic Liver Failure in adult. Half participants will receive G-CSF and standard~     treatment in combination, while half participants will receive standard treatment.~   "
94309|NCT02332720|"~     This is a randomized, three-part, parallel-group, open-label trial of grazoprevir (MK-5172)~     (100 mg) and Uprifosbuvir (MK-3682) (300 mg or 450 mg) with either elbasvir (MK-8742) (50 mg)~     or ruzasvir (MK-8408) (60 mg), and with and without ribavirin (RBV), in treatment-naive (TN)~     or treatment-experienced (TE) cirrhotic (C) or non-cirrhotic (NC) participants infected with~     hepatitis C virus (HCV) genotype (GT) 3, GT4, GT5, or GT6. Part A will consist of 4 arms to~     evaluate the safety of dose combinations. In Part B, participants will take 2 uprifosbuvir~     (+) grazoprevir (+) ruzasvir (MK-3682B) fixed dose combination (FDC) tablets once daily~     (q.d.) by mouth, with or without twice-daily (b.i.d.) RBV (200 mg capsules; weight-based~     dosing). Participants who relapse following completion of therapy in Part A will be offered~     the option of retreatment with 16 weeks of uprifosbuvir (+) grazoprevir (+) ruzasvir with RBV~     in Part C (data obtained from Part C will not be used in the analysis of outcome measures).~   "
94310|NCT02332707|"~     This is a randomized, three-part, open-label trial of grazoprevir (GZR; MK-5172) (100 mg) and~     uprifosbuvir (UPR; MK-3682) (300 mg or 450 mg), with either elbasvir (EBR; MK-8742) (50 mg)~     or ruzasvir (RZR; MK-8408) (60 mg), and with or without ribavirin (RBV), in treatment-naïve~     (TN) cirrhotic (C) or non-cirrhotic (NC) hepatitis C virus (HCV) participants with chronic~     HCV genotype (GT) 1 or GT2 infection. Part A will consist of 8 arms to evaluate the safety of~     dose combinations. In Part B, participants will take 2 UPR+GZR+RZR fixed dose combination~     (FDC) tablets once daily (q.d.) by mouth, with or without twice-daily (b.i.d.) RBV (200 mg~     capsules; weight-based dosing). Participants who relapse following completion of therapy in~     Part A will be offered the option of retreatment with 16 weeks of UPR+GZR+RZR with RBV in~     Part C (data obtained from Part C will not be used in the analysis of outcome measures).~   "
94311|NCT02332694|"~     Fibromyalgia has become an increasingly pressing public health problem in the United States.~     Although some treatments exist for Fibromyalgia, many individuals suffering with Fibromyalgia~     do not adequately respond to currently available treatment options, highlighting the need to~     develop and test new interventions for the disorder. To address this pressing clinical issue,~     we will conduct a pilot study to determine if Whole Body Hyperthermia (WBH) reduces symptoms~     in adults suffering from Fibromyalgia. We plan to recruit individuals with Fibromyalgia who~     will receive a single session of WBH to determine if this single session improves~     Fibromyalgia symptoms and if so whether this improvement will last at least 2 weeks. To do~     this, the study will include self-report symptom assessments immediately before and one and~     two weeks after WBH. In addition blood will be collected at these time points to explore~     whether WBH changes immune system chemicals that are believed to contribute to fibromyalgia.~     We intend to conduct the study until 10 individuals with fibromyalgia have received a single~     treatment of WBH and have completed all pre-treatment and post-treatment assessments. Given~     scientific evidence from our research group that WBH may improve depression, we anticipate~     that it may also be of benefit or adults suffering from Fibromyalgia.~   "
94312|NCT02332681|"~     Osteoporosis is a systemic bone disease characterized by low bone mass and microarchitectural~     deterioration of bone tissue with consequent bone fragility and susceptibility to fracture.~     Fifty percent of women and 20% men older than 50 y.o. will have an osteoporotic fracture~     (fragility fracture). Fragility fracture is defined as one that results from a low-energy~     trauma such as a fall from body height. A previous fracture is an important predictor of a~     new fracture, especially in the first 5 years after initial fracture. A second fracture can~     be particularly devastating if it is a hip fracture. Low bone mineral density, measured by~     bone densitometry, as well as a previous osteoporotic fracture, are the two major risk~     factors for the occurrence of a new fracture.~      A more rational approach currently used to minimize the costs of health care in a shorter~     period of time uses the strategy of firstly preventing the occurrence of secondary fracture,~     followed by primary prevention strategies. In this context, correct identification of~     fragility fractures and consequent treatment of those individuals is imperative. There are~     currently insufficient data about the epidemiology and evolution of other fragility~     fractures, also known as non-vertebral non-hip fracture (NVNH). Among these, distal radius~     fracture and proximal humerus fractures are the most frequent. There is a type of fracture,~     however, that is simply ignored by the medical community: the knee insufficiency fracture.A~     possible explanation for this information gap could be the fact that, until a few years ago,~     this entity was believed to be a osteonecrosis of the knee. Only recently it is becoming~     clear that the cause of pain and marrow bone edema that occur subtly in older individuals is,~     in fact, a insufficiency fracture. The perception that this lesion is actually a fracture is~     relatively new. The knee insufficiency fracture usually occurs in older individuals and those~     with knee osteoarthritis. This study therefore aims to evaluate whether there is a relation~     between knee insufficiency fracture and osteoporosis. Moreover, it is expected to find out if~     this fracture may be defined as a fragility fracture, electing the individuals affected by it~     to a prophylaxis for the occurrence of new osteoporotic fracture.~   "
94313|NCT02332668|"~     This is a two-part study of pembrolizumab (MK-3475) in pediatric participants who have any of~     the following types of cancer:~        -  advanced melanoma (6 months to <18 years of age),~        -  advanced, relapsed or refractory programmed death-ligand 1 (PD-L1)-positive malignant~          solid tumor or other lymphoma (6 months to <18 years of age),~        -  relapsed or refractory classical Hodgkin lymphoma (rrcHL) (3 years to <18 years of age),~          or~        -  advanced relapsed or refractory microsatellite-instability-high (MSI-H) solid tumors (6~          months to <18 years of age).~      Part 1 will find the maximum tolerated dose (MTD)/maximum administered dose (MAD), confirm~     the dose, and find the recommended Phase 2 dose (RP2D) for pembrolizumab therapy. Part 2 will~     further evaluate the safety and efficacy at the pediatric RP2D.~      The primary hypothesis of this study is that intravenous (IV) administration of pembrolizumab~     to children with either advanced melanoma; a PD-L1 positive advanced, relapsed or refractory~     solid tumor or other lymphoma; advanced, relapsed or refractory MSI-H solid tumor; or rrcHL,~     will result in an Objective Response Rate (ORR) greater than 10% for at least one of these~     types of cancer.~   "
94314|NCT02332655|"~     The purpose of this study is to determine the tolerability and optimal dose of cannabidiol~     (CBD) as an simultaneous treatment in children and young adults with Sturge-Weber syndrome~     (SWS) and drug resistant epilepsy.~   "
94315|NCT02332642|"~     This pilot clinical trial aims at evaluating immuno-modulating effects of palliative~     treatment with specifically dosed standard chemotherapeutics in patients with metastatic~     melanoma (AJCC stage IV) by assessing myeloid-derived suppressor cells' (MDSCs) count and~     activity.~   "
94316|NCT02332629|"~     This study evaluates the pathophysiological effects of a single dose methylprednisolone~     administered prior to total knee-arthroplasty surgery (TKA). The investigators examine the~     effect on the endothelial glycocalyx shedding due to surgical trauma.~      Half of participants will receive intravenous Solu-Medrol 125 mg, while the other half will~     receive placebo.~      The investigators hypothesize that the group receiving methylprednisolone will experience~     reduction in glycocalyx degradation compared to the placebo-group, early after TKA.~   "
94319|NCT02332590|"~     Primary Objective:~      To demonstrate that sarilumab monotherapy was superior to adalimumab monotherapy with respect~     to signs and symptoms as assessed by disease activity score 28 (DAS28)-erythrocyte~     sedimentation rate (ESR) in participants with active rheumatoid arthritis (RA) who were~     either intolerant of, or considered inappropriate candidates for continued treatment with~     methotrexate (MTX), or after at least 12 weeks of continued treatment with MTX, were~     determined to be inadequate responders.~      Secondary Objectives:~      To demonstrate that sarilumab monotherapy was superior to adalimumab monotherapy in~     participants with active RA who were either intolerant of, or considered inappropriate~     candidates for continued treatment with MTX, or after at least 12 weeks of continued~     treatment with MTX, were determined to be inadequate responders, with respect to:~        -  Reduction of signs and symptoms of RA.~        -  Improvement in quality of life assessed by participant reported outcome questionnaires.~      Assessment of the safety and tolerability of sarilumab monotherapy (including immunogenicity)~     throughout the study.~   "
94320|NCT02332577|"~     Primary Objective:~      To evaluate the clinical efficacy of pristinamycin at a dose of 2g x 2/day for 2 days then 1g~     x 3/day for 5 to 7 days versus amoxicillin 1g x3 /day for 7 to 9 days, 5 to 9 days after the~     end of treatment.~      Secondary Objectives:~      To evaluate the clinical efficacy in a subpopulation bacteriologically documented at~     inclusion and according to procalcitonin level.~      To evaluate the efficacy of treatments against pneumococcus. To evaluate the rate of relapse~     and mortality 30±2 days after treatment is started.~      To document failures. To collect and follow up adverse events.~   "
94321|NCT02332564|"~     CORONARY ARTERY DISEASE AND THE BENEFIT OF BYPASSES Despite considerable advances in~     medicine, cardiovascular diseases remain the number one cause of death globally. In~     industrialized countries, coronary artery disease (CAD) is the leading cause of death,~     consequence of myocardial infarction (MI). Artificial - or natural - bypasses exert a~     protective effect by providing an alternative source of blood flow to a myocardial territory~     potentially affected by an acute coronary occlusion. Coronary collaterals represent~     pre-existing inter-arterial anastomoses and as such are the natural counter-part of~     surgically created bypasses. In patients with chronic CAD, sufficient coronary collaterals~     have been shown to confer a significant benefits in terms of overall mortality and~     cardiovascular events.~      EXTRACARDIAC-TO-CORONARY COLLATERAL SUPPLY Commonly, coronary collaterals are implicitly~     understood to exist between coronary artery branches. However, the structural existence of~     coronary collaterals with an extracardiac connection has been confirmed by anatomical~     investigations. Pathophysiologically and with regard to a potential for arteriogenic~     stimulation, the connections from the internal mammary arteries, are of special interest.~      In a recently published work the investigators have investigated the effect of temporary~     balloon occlusion of the distal IMA on coronary collateral function. There were equivocal~     findings for the left circumflex coronary artery: CFI was increased by ipsilateral IMA~     occlusion, but the level of myocardial ischemia was unchanged.~      MYOCARDIAL STEAL VIA INTERNAL MAMMARY ARTERIES In the investigators' previous study, the~     coronary occlusion with simultaneous distal IMA occlusion was always performed first as a~     conservative measure against false-positive detection of internal-mammary-to-coronary artery~     connections. Repetitive coronary occlusions per se result in higher collateral flow by~     collateral recruitment and reduced ischemia by ischemic preconditioning and augmented~     collateral function. Conversely, the sensitivity of the employed method was reduced and might~     have contributed to the equivocal findings in case of the left circumflex artery. Moreover,~     the hypothesize d mechanism of localized pressure augmentation was not investigated.~      This study aims to further characterize the prevalence and function of natural ipsilateral~     IMA-to-coronary connections, as well as to investigate the hemodynamic mechanisms of coronary~     collateral function augmentation by distal IMA occlusion. In the investigators' last study,~     the increased coronary collateral function in response to manipulation of a potential~     coronary collateral donor (in this case, the IMA) was taken as indirect evidence for the~     existence of IMA-to-coronary-artery connections. Thus, the employed distal IMA occlusion~     served as a positive stimulus. Conceptually, additional evaluation with a negative stimulus~     could heighten the discriminatory power of the investigation. This could be in the form of a~     hyperemic stimulus affecting the collateral donor, ie in analogy to myocardial or coronary~     steal (ie, a reduction in coronary collateral supply to a collateral recipient).~   "
94322|NCT02332551|"~     The purpose of this study is to investigate the safety and efficacy of irreversible~     electroporation for unresectable Hepatic carcinoma close to the gallbladder, also Progress~     Free Survival (PFS) will be recorded.~   "
94323|NCT02332538|"~     Most guidelines are not strict for recommending single treatment approach for Moderate to~     large prostate.~      In this study the investigators planned to test the Greenlight (532-nm) laser Photoselective~     Vapo-Enucleation of the Prostate (PVEP) using (XPS) 180W system compared to bipolar~     transurethral resection of the prostate (TURis) and Holmium Laser Enucleation of the Prostate~     (HOLEP) in reduction of lower urinary tract symptoms (LUTS) secondary to BPH in a prospective~     randomized trial.~   "
94324|NCT02332525|"~     The purpose of this study is to investigate the effect of oral vibratory stimulus on the~     brain activity and cognitive function of elderly people with non-dementia subjects (cognitive~     normal, mild cognitive impairment)~   "
94325|NCT02332512|"~     Apatinib is a new kind of selective Vascular Endothelial Growth Factor Receptor 2(VEGFR-2)~     tyrosine kinase inhibitor (TKI). The investigators have finished the preclinical,phase I and~     phase II clinical studies and found its promising anti-tumor activity and tolerable~     toxicities. A disease-control rate of 61.1% and a mPFS of 4.7 months were showed in apatinib~     phase II study in patients with NSCLC.~      The study aims to compare the efficacy and safety of apatinib to placebo in advanced~     non-squamous non-small cell lung cancer patients.~   "
94326|NCT02332499|"~     The purpose of this study is to compare the effects and safety of Anlotinib with placebo in~     patients with metastatic colorectal cancer refractory to standard chemotherapies.~   "
94327|NCT02332486|"~     Due to the change of life style, the incidence of oral cavity mucous membrane disease~     increased.In this study，been done a large number of pre-clinical practice and some~     experimental studies， based on the application of metabolomics technology to ultra-high~     liquid-mass spectrometry metabolomics analyzer as the core means， The metabolism of pattern~     recognition and combination of modern analytical techniques to measure blood and urine of~     patients with OLP-specific clearance of endogenous metabolites，and after the intervention of~     moss drink endogenous metabolites in the body as a whole group of. At the same time， the use~     of flow cytometry,，ELISA， immunohistochemistry and other modern technology, research OLP~     patients using clean moss drink before and after treatment of local lesions and peripheral~     blood CD4 +，CD8 + lymphocytes，Th1 cytokines (IFN-γ， TNF-α)， Th2 cytokines (IL-4，10) the~     dynamic changes. From metabolomics， cellular immunology， inflammation mechanism perspective~     of local OLP lesions， peripheral blood and changes in endogenous metabolites in the~     process,，in-depth study of traditional Chinese medicine to drink clean moss multi-component~     multi-target treatment of this disease mechanism， is widely used in traditional Chinese~     medicine treatment of OLP provide a theoretical basis for the promotion of Chinese medicine~     Qingxian Yin in the oral mucosal disease in the application， effectively solve clinical~     practice problems.~   "
94328|NCT02332473|"~     This study is a multi-center, randomized, prospective open-label study to assess the efficacy~     and safety of combination of peginterferon alfa-2b (40kD, Y-shape) and GM-CSF in~     interferon-naïve chronic hepatitis B patients with HBeAg positive. Patients were randomized~     to one of the 2 groups to receive different antiviral treatment.~   "
94329|NCT02332460|"~     Infliximab is the active ingredient in a drug currently sold by the trade names Remicade,~     Remsima and Inflectra. Infliximab neutralizes tumor necrosis factor (TNF) α, a chemical~     messenger (cytokine) in the immune system, and belongs to a class of drugs called TNF~     inhibitors. 8-55% of patients receiving infliximab have an infusion reaction. Infusion~     reactions are unintended reactions that occur during infusion of the drug and up to 14 days~     after. The incidence varies widely in different studies and seems difficult to determine due~     to variations in reporting of reactions, different definitions of reactions and retrospective~     data collection. The aim of this study is to estimate the incidence of infusion related~     reactions and investigate risk factors and immunological mechanisms of infusion reactions to~     infliximab in patients with a chronic inflammatory disease.~   "
94330|NCT02332447|"~     Sudden unexpected death in epilepsy (SUDEP) primarily affects young adults with~     drug-resistant epilepsy, with an incidence of about 0.4%/year. The diagnosis of SUDEP~     requires that anamnestic data and post-mortem examination do not reveal a structural or~     toxicological cause for death. Generalized tonic-clonic seizures (GTCS) are the main risk~     factor for SUDEP, which they appear to trigger in most instances. Indeed, experimental and~     clinical data strongly suggest that most SUDEP result from a postictal respiratory~     dysfunction progressing to terminal apnea, later followed by cardiac arrest.~      Postictal apnea could partly derive from a seizure-induced massive release of endogenous~     opioids. Animal studies suggest that such seizure-related release of endogenous opioid~     peptides participate to termination of seizures. In patients with epilepsy, functional~     imaging studies have confirmed that seizures induce release of endogenous opioids. The~     brainstem respiratory centers contain the highest density in opioid receptors, accounting for~     respiratory depression being one of the cardinal symptoms of opioid overdose.~      The investigators hypothesis is that SUDEP partly results from a post-ictal apnea promoted by~     a GTCS-induced massive release of endogenous opioids, and that an opioid antagonist could~     represent an effective preventive treatment of SUDEP. This could be achieved by chronic~     administration of Naltrexone, an opioid antagonist that has been used in a large population~     of patients with chronic alcoholism at high risk of seizures, without showing any~     pro-convulsant effect. This is a crucial feasibility issue since antagonising a mechanism~     thought to participate to seizure termination could theoretically aggravate seizures.~      Before evaluating the efficacy of chronic administration of naltrexone, it is legitimate to~     perform a proof of concept study by testing the acute effect of an equivalent injectable~     treatment (Naloxone) in the immediate aftermath of GTCS recorded inhospital during video-EEG~     monitoring of patients with refractory epilepsy. One third of these patients develop~     postictal respiratory dysfunction and hypoxemia, which should be reduced by the investigators~     intervention if the investigators hypothesis is correct.~      The main objective of the study is to evaluate the efficacy of 0.4 mg intravenous naloxone,~     versus placebo, administered in the immediate aftermath of a GTCS, in reducing the severity~     of the postictal central respiratory dysfunction occurring after the end of the seizure, as~     measured by pulse oximetry.~      About 25% of patients with drug-resistant partial epilepsy who undergo long-term video-EEG~     monitoring develop at least one partial secondary generalized tonic-clonic seizure. However,~     these patients cannot be individualized a priori. Therefore, all adult patients with~     drug-resistant epilepsy who will undergo long-term video-EEG monitoring in one of the~     participating centres, will lack all exclusion criteria, and will give their written informed~     consent to participate to the study if they develop GTCS, will be included in the study. They~     will all benefit from continuous monitoring of pulse oximetry (together with video, EEG, and~     respiration recordings), and will be equipped with a peripheral venous catheter throughout~     the video-EEG. The modalities of the video-EEG monitoring will be consistent with the current~     practices and similar across the 14 centres (apart from the venous catheter which is not~     standard practice).~      In case of occurrence of a generalized tonic-clonic seizure, patients will be randomized~     (1:1) to receive intravenous naloxone (0.4 mg) or placebo. Placebo will be isotonic sodium~     chloride which preparation and packaging will be centralized to ensure its~     indistinguishability from naloxone. Randomization will be centralized and stratified by~     centre. The evolution from a partial seizure to a GTCS being gradual, and the total duration~     of the seizure ranging from 2 to 3 minutes, the injection will be prepared during the course~     of the seizure. Given the assumptions about the role of endogenous opioids release in the~     spontaneous termination of seizures, naloxone will be administrated immediately after the end~     of the GTCS and not before.~      All digital data (video, EEG, respiration, SpO2) will be centralized and evaluated blind to~     other data by the PI of the study who will not be involved in the video-EEG monitoring of the~     included patients. The same automatic and objective analysis of SpO2 data than the one~     already developed in the PHRC REPOMSE will be performed.~   "
94396|NCT02331589|"~     Background: Korea red ginseng (KRG) has anti-carcinogenic activity, anti-oxidant activity,~     and cancer related anti-fatigue.~      Methods: Seventy five patients with non-alcoholic hepatitis were prospectively randomized to~     receive 3 weeks of KRG or placebo. Liver function test, pro-inflammatory cytokines,~     adiponectin, fatigue severity scale, and antioxidant activity were check and compared.~   "
94397|NCT02331576|"~     The purpose of this study is to evaluate the analgesic efficacy of perineural fentanyl~     combined with local anesthetics in the post operative pain control with continuous femoral~     nerve block after total knee arthroplasty.~   "
94331|NCT02332434|"~     Rational: The world and french epidemic of obesity and diabetes represents a major problem of~     public health. The prevalence in France, in the adult population, is 15 % corresponding to~     6.9 million people for obesity and 6 % corresponding to 3.9 million people for diabetes.~     Morbidly obesity (body mass index 40 kg/m²), the most serious, is more and more frequent.~     Cardiovascular diseases are the first cause of morbidity and mortality. The atherogenic~     dyslipidemia of these insulin-resistant obese type 2 diabetic patients characterized by the~     quartet: elevated plasma triglycerides, low high-density lipoprotein-cholesterol, increased~     proportion of small and dense low-density lipoproteins, is widely explained by the blood~     accumulation of TRL from the liver and the intestine, and represents a major cardiovascular~     risk factor. The overproduction of intestinal TRL (which apoprotein B48 is the specific~     tracer) is a constituent recently recognized of insulin-resistance and the atherogenous role~     of these intestinal TRL has been shown. In view of this important overmortality and the~     failures of the medical, nutritional, dietary and psychotherapeutic combined treatment, the~     bariatric surgery quickly developed. Two main procedures are performed: 1 based exclusively~     on the gastric restriction (the sleeve gastrectomy) and one associating a malabsorption (the~     gastric bypass).~      Objectives: The main objective of this study is to compare the effect of each surgical~     procedure and the differential effect of the 2 bariatric surgery procedures on the production~     and clearance rates of the intestinal TRL. The secondary objectives are to compare the effect~     of each surgical procedure and the differential effect of the 2 bariatric surgery procedures~     on the production and clearance rates of the hepatic TRL and to document the potential links~     between the expected reduction of these productions after the surgery and the loss of weight,~     the improvement of the insulin-sensitivity, the changes in hormones, the decrease of the~     inflammatory state, the changes in energy expenditure, body composition and energy intake.~      Methods: It is a multicentric, prospective, comparative study of cohorts. After~     identification of the eligible subjects, the kinetics (production and clearance rates) of~     intestinal and hepatic TRL will be performed in the hospital, using established stable~     isotope enrichment methodology (5,5,5-D3-L-Leucine), in 2 groups of obese patients (15~     patients per surgery procedure), before and 6 months after the surgery.~      Perspectives: A better understanding of the dyslipidemia of obese type 2 diabetic patients~     and the factors modulating this dyslipidemia may lead to develop new dietary and/or drugs~     and/or surgical treatments targeted at the enterocyte to improve the lipid profile of these~     patients and reduce the incidence of cardiovascular diseases. Moreover, a differential effect~     between the 2 surgical procedures could help to choose the best surgical procedure for obese~     type 2 diabetic patients depending on the lipid profile at baseline.~   "
94332|NCT02332421|"~     In this study, two distractors will be used to retract maxillary canines into the extraction~     sites. The first distractor is a modified Hyrax expander with two arms soldered to two bands~     connected to a canine and a molar; and the second one is a similar to the first one but with~     the addition of a third arm.~      The purpose of this investigation is to compare the two distractors in terms of: final~     position of the canine, canine pulp vitality, molars' anchorage, patient's acceptance to the~     appliance.~   "
94333|NCT02332408|"~     Clinical objective of the study is to compare the analgesic effect, toxicity and pathologic~     effect in the tumors of two radiotherapy schedules used for patients suffering from painful~     vertebral haemangiomas~   "
94334|NCT02332395|"~     The aim of this study is to determine the effect of surgical priority either emergency or~     elective on postoperative pain in caesarean section operations. Patients whose undergo~     caesarean section operation are included into this study. Patients will invite to complete~     the Pain Catastrophizing Scale questionnaire in preoperative period. The patients will be~     divided into two groups in terms of applied surgical priority whether emergency or elective.~     After caesarean section, patient controlled analgesia is used for pain relief. And the~     intensity of pain will be measured by using numerical rating scale.~   "
94335|NCT02332382|"~     The research subject~      Health organizations around the world have determined that breastfeeding is the most critical~     source of nutrition for newborns in the first weeks and months of their lives. A mother's~     breast milk contains unique nutritious components and other nonnutritive elements that help~     promote healthy baby growth and development (1, 2). Recent studies show that a mother's~     breast milk contains components that vary from each specimen. There are great evidences that~     maternal and environmental factors have a strong influence on the composition of breast milk.~     Fatty acids, the second most common component found in breast milk, show extreme sensitivity~     to maternal nutrition (3, 4).~      Latest studies show that breast milk also contains bacterial communities that may have health~     implications of newborn. The structure of these bacterial communities also varied greatly~     between subjects (5) .~      In the research, we propose to investigate the connection between maternal nutrition,~     different fatty acids and their role in the growth and development of bacterial populations~     existing in breast milk.~   "
94336|NCT02332369|"~     This study evaluates the safety and effectiveness of a capsular tension ring (CTR) when used~     during cataract surgery. Capsular Tension Rings are used during intraocular lens implantation~     to give added support in order to keep the intraocular lens well centered, especially in eyes~     with weak or partially absent zonules. In many cases, capsular tension rings allow a lens to~     be successfully implanted into an eye which otherwise could not have supported an intraocular~     lens, and have enabled patients to regain normal activities again after cataract surgery.~   "
94337|NCT02332356|"~     This randomized, controlled study aims to evaluate the impact of therapeutic intervention~     (step up) for the patients who are clinical remission with Magnetic Resonance~     Enterocolonography (MREC) active. In addition, to evaluate the impact of therapeutic step~     down for the patients who archived clinical and MREC remission. The primary endpoint is the~     rate of clinical remission at 104 weeks.~   "
94338|NCT02332343|"~     Dry age-related macular degeneration (AMD) is a common cause for severe visual loss in the~     elderly and represents an unmet need. So far no treatment is available for geographic atrophy~     (GA), which represents the advanced dry form characterized by expanding areas of outer~     retinal atrophy with corresponding absolute scotoma. The foveal retina may be spared until~     late in the course of the disease, a phenomenon termed foveal sparing. However, the disease~     process ultimately also involves the central retina leading to irreversible loss of central~     vision. While the natural history of eyes with GA has been extensively studied with regard to~     the entire atrophic area, morphology-function analyses for foveal sparing GA in particular~     are still missing. Such data are needed for various purposes including the future use in~     interventional pharmacological trials aiming to slow the progression of GA and to preserve~     the foveal retina. In this study, different imaging modalities for accurate detection and~     quantification of preserved foveal retinal areas will be assessed.~   "
94339|NCT02332330|"~     This study is designed to collect post market data on use of the VEST, particularly on~     saphenous vein grafts to the right territory of the heart.~   "
94340|NCT02332317|"~     The purpose of this study is to identify whether patients with newly diagnosed advanced~     cancer benefit from a 12-week palliative rehabilitation program integrated with standard~     oncology treatment.~   "
94341|NCT02332304|"~     To determine the relationship between the result of amniotic fluid optical density between 26~     and 36 6/7 weeks of pregnancy and the risk of developing neonatal respiratory distress~     syndrome.~   "
95361|NCT02318940|"~     The purpose of this study is to compare the effectiveness and safety of the installation of~     femoral central venous catheter (CVC) ultrasound-guided real-time 2D versus the landmark~     method~   "
94342|NCT02332291|"~     It can be difficult to achieve remission in individuals with late-life depression (LLD) and~     they often require aggressive treatment. This challenge is in part due to age-related~     vascular changes that are common in LLD. Successful antidepressant treatment involve changes~     across affective, cognitive, and default mode networks. We hypothesize that in LLD, vascular~     disease adversely affects response to antidepressants by disrupting connectivity of these~     networks. The primary goal of this project is to characterize how focal vascular damage~     affects regional connectivity and response to antidepressants. Based on past work and pilot~     data, we a priori focus on the cingulum bundle and uncinate fasciculus. These key fiber~     bundles connect frontal, temporal, and cingulate regions involved in cognition and affective~     responses. Our central hypothesis is that ischemic damage to the cingulum bundle and uncinate~     fasciculus contributes to structural and functional connectivity deficits of those tracts.~     This results in a disconnection effect that alters the function of connected regions. In~     turn, this increases the risk of a poor response to antidepressants.~      Our approach is to enroll up to 130 adults over age 60 years with a diagnosis of Major~     Depressive Disorder. Subjects will complete clinical evaluation, cognitive testing, and~     MRI/functional MRI (fMRI) sessions, including an fMRI emotional oddball task that includes~     attentional and affective components. Participants will be stratified by cerebral lesion~     severity and randomized in a 2:1 ratio to a double-blinded 8-week trial of escitalopram or~     matching placebo. Those who do not remit will transition to an 8-week trial of open-label~     bupropion, an antidepressant with a different mechanism of action. This will allow us to~     determine if different and distinct circuit deficits affect response to antidepressants with~     different mechanisms of action while also accounting for the placebo response.~   "
94343|NCT02332278|"~     To determine the effect in the post operative period of early feeding (4 hours after surgery)~     vs. traditional management (feeding 12 hours after surgery) in uncomplicated cesarean~     section.~   "
94344|NCT02332265|"~     The purpose of this study is to evaluate a multilevel economic and food security program~     (Support to Able-Bodied Vulnerable groups to Achieve Food Security; SAFE) in rural central~     Malawi as implemented and assigned by CARE-Malawi on HIV vulnerability and other health~     outcomes.~      Hypothesis: HIV vulnerability can be reduced through a coordinated set of locally tailored~     individual and structural interventions that reduces poverty, reduces food insecurity,~     strengthens community bonds, and addresses gender inequality.~   "
94345|NCT02332252|"~     To determine the risk of surgical site infection after surgical skin incision, comparing~     electrocautery vs. scalpel.~   "
94346|NCT02332239|"~     The purpose of this randomized controlled study is to evaluate acceptability and feasibility,~     and to gather preliminary data about efficacy, of iDOVE, a brief emergency department~     introductory session + longitudinal automated text-message depression prevention program for~     high-risk teens.~   "
94347|NCT02332226|"~     The aim of this project is to evaluate a person-centred informational intervention aimed at~     parents of children with cancer.~      The following hypotheses will be tested: an informational intervention emanating from the~     parents' self-identified needs is associated to decreased illness-related parenting stress,~     decreased post-traumatic stress symptoms, increased received knowledge, decreased anxiety,~     decreased depression, increased satisfaction with information, and decreased number of health~     care contacts in parents.~   "
94348|NCT02332213|"~     The study is aimed to determine the potential of volatile marker testing for identification~     of gastrointestinal cancers (in particular - colorectal and gastric cancers), the related~     precancerous lesions in the stomach and colon.~      The study will be addressing the role of confounding factors, including lifestyle factors,~     diet, smoking as well as addressing the potential role of microbiota in the composition of~     exhaled volatile markers.~   "
94349|NCT02332200|"~     This is a retrospective chart review with a short follow-up phone questionnaire for our~     patients who have been treated by Nationwide Children's Hospital physical therapy and sports~     medicine for a spondylolysis or spondylolisthesis injury.~      Currently, no research exists to guide referral for safe physical therapy rehabilitation for~     patients with spondylolysis and spondylolisthesis injuries. By performing this retrospective~     study the investigators can gain information to better guide physical therapy referral time.~     This may also serve as foundation for a future prospective randomized trial.~      Currently, Nationwide Children Hospital physicians vary from immediate referral to physical~     therapy to 3 + months of rest prior to beginning therapy. By performing a retrospective chart~     review assessing time to referral to therapy and patient outcomes the investigator can gain~     some guidance for when it is safe to prescribe physical therapy rehabilitation for patients~     with spondylolysis and spondylolisthesis injuries.~      Patients with an active spondylolysis or spondylolisthesis injury who are referred to~     physical therapy early will return to activity/sport sooner without increased risk of adverse~     reaction.~   "
94350|NCT02332187|"~     Patients that are on mechanical ventilators in medical intensive care units (MICU) have~     extremely weak leg muscles. Currently there is no treatment to prevent or reverse this~     weakness. Treatments with a thigh muscle stimulator, called an All Stim 2, can improve leg~     muscle strength and help patients regain leg function after knee surgery. The purpose of the~     present study is to determine if treatments with the All Stim 2 device can also improve leg~     muscle strength in patients on mechanical ventilation.~   "
94351|NCT02332174|"~     The purpose of this study was to determine the pharmacokinetic (PK) and safety profile of~     single and multiple doses of rufinamide. The effects of food and sex on the PK properties of~     rufinamide in these Chinese volunteers were also evaluated.~   "
94352|NCT02332161|"~     Anterolateral thigh (ALT) free flap tissue transfer is a commonly used method of head and~     neck reconstruction after head and neck cancer removal. The procedure involves removing some~     muscle, skin, and tissue from the thigh, and this may affect leg function. The purpose of~     this study is to determine the impact of ALT on ambulation and activities of daily living~     (ADLs)~   "
94353|NCT02332148|"~     3VM1001 is a topical cream that may be useful for the treatment of chronic osteoarthritis of~     the knee. This proof of concept study is a randomized, placebo-controlled, double-blind study~     to compare treatment with 3VM1001 cream to an inactive cream placebo. Subjects will~     self-treat for 30 days.~   "
94354|NCT02332135|"~     Microwave ablation, as a new method to therapy secondary hyperparathyroidism(SHPT), now is~     developing rapidly. However, it is still unknown whether it is effective to accept microwave~     ablation for hemodialysis patients with mild-to-moderate SHPT. In this prospective,~     randomised control and paried clinical trial study, the investigators will observe the~     efficiency and safety of microwave ablation in hemodialysis patients with mild-to-moderate~     secondary hyperparathyroidism. The patients in age-matched control group will accept active~     Vitamin D therapy.~   "
95448|NCT02317796|"~     A Multi-center, Double Blind, Randomized, Placebo-controlled, Parallel Group Phase IIa Study~     of MLR-1023 in Adult Subjects With Uncontrolled Type 2 Diabetes~   "
95449|NCT02317783|"~     The initial goal of the investigators interdisciplinary group of imagers, oncologists,~     neurologists, neuro-psychologists, and biostatisticians is to obtain proof of concept pilot~     data for eventual submission of a National Cancer Institute Quick-Trial for Imaging and~     Image-Guided Interventions: Exploratory Grant (R10) depending on the results of this pilot~     study.~      The overall objective is to use [18F]Flutemetamol, FDG-PET, and MRI to better understand~     CICI, which effects up to 16 -50% of individuals receiving long-term adjuvant~     chemotherapy.2,3 To date there have been few studies examining this problem using~     multi-modality imaging techniques to better understand this complex and significant problem.~      FDG-PET and MRI are routinely used in clinical practice for the evaluation of cognitive~     dysfunction in older populations complaining of memory dysfunction. It is well recognized~     that FDG-PET can assist with the differentiation and characterization of various cognitive~     disorders due to unique patterns of cerebral metabolism caused by various cognitive and~     dementia-causing disorders.4-6 FDG-PET has been studied extensively in dementia research and~     has a high reliability in detecting Alzheimers disease (AD) many years before it can be~     diagnosed reliably using clinical criteria.4~      To the investigators knowledge, there has been only a single small study using FDG-PET and~     bolus water activation paradigms in cancer patients complaining of memory problems.7 To date,~     there have been no studies using [18F]Flutemetamol as a PET imaging agent to assess the~     possibility of increased amyloid plaque burden as a potential contributing factor to the~     cognitive deficits and complaints seen in patients experiencing CICI. The novel feature of~     this project is in the combined use of [18F]Flutemetamol-PET, FDG-PET, and anatomic MRI to~     study a poorly understood but common problem: cognitive impairment in breast cancer patients~     treated with chemotherapy.~      If [18F]Flutemetamol, FDG-PET, and MRI can provide information on the pathophysiology of this~     disorder, it will be an important step in better understanding the etiology of this~     phenomenon and possibly other conditions resulting in cognitive dysfunction. These imaging~     assessments will make it possible to explore any altered changes in cerebral structure,~     metabolism, and amyloid deposition that may be responsible for CICI. This may help to predict~     which individuals may be affected by this problem and provide information for eventual~     therapeutic strategies to treat this common cancer-associated disorder.~      This study will use [18F]Flutemetamol and FDG-PET imaging to assess and quantify the amyloid~     plaque burden and cerebral glucose metabolism, respectively, in breast cancer patients~     suffering from CICI and correlate those findings with structural changes on MRI. The~     [18F]Flutemetamol and FDG-PET scans of these study patients will then be compared to two GE~     software databases (CortexID-FDG and CortexID-Flutemetamol) which contain scan data from~     healthy control individuals to evaluate for abnormalities in cerebral glucose metabolism and~     amyloid plaque burden differing from the values expected for individuals in their age range.~   "
94355|NCT02332122|"~     A single center case-control study with 100 COPD patients will be organized to compare~     patients with and without bronchiectasis with regard to the presence of Aspergillus in sputum~     samples, Aspergillus sensitization and vitamin D. Induced sputum samples will be optimized~     for culture, Aspergillus galatomannan analysis and RT-PCR.~      This study is part of a larger project in which we assume that chronic respiratory infection~     by Aspergillus fumigatus and the accompanying immune response play an important role in the~     development of bronchiectasis in COPD. We suspect that this mechanism is controlled by~     vitamin D and it fails by suppression of the vitamin D receptor by Aspergillus fumigatus.~      The present study is designed by the Laboratory of pneumology and will be conducted in~     collaboration with the Laboratory of clinical bacteriology and mycology of the Catholic~     University of Leuven.~   "
94356|NCT02332109|"~     Clinical observation to confirm the clinical safety and efficacy of ODM 5 in the treatment of~     corneal edema caused by Fuchs' endothelial dystrophy.~   "
94357|NCT02332096|"~     Diagnosis and treatment of sleep apnea with continuous positive airway pressure (CPAP)~     therapy has been shown to decrease arrhythmia recurrence in patients with AF following~     ablation. However, patients with AF undergoing ablation are not routinely screened for sleep~     apnea, despite an estimated sleep apnea prevalence of 25% in the general population, and~     perhaps higher among patients with AF. Home sleep testing is frequently used for evaluation~     of sleep apnea.~   "
94358|NCT02332083|"~     The goal of this randomized controlled study was to examine the effects of a 8 weeks~     innovative training regime (stochastic resonance whole-body vibration [SR-WBV] and virtual~     virtual games [VG]) in the skilling up phase on physical performance, cognition and falls in~     elderly in need of care population.~   "
94359|NCT02332070|"~     1. To examine two main predictor variables independently and then jointly in stratified and~          multivariate analyses for the outcomes of CSA-AKI, MARCE, need for RRT, and inpatient~          mortality, and the composite, as well as the outcomes of 30 day rehospitalization or~          death, and finally for the days out of hospital and alive adjusted to person-year of~          time~             1. Days from coronary angiogram performed with IOCM to cardiac surgery (1, 2, 3, etc)~             2. Thakar Acute Renal Failure (ARF) score (1 to 17)~        2. To examine the interrelationships between time in days between angiogram and surgery and~          the ARF Score with the Society of Thoracic Surgery (STS) Risk score for mortality~   "
94360|NCT02332057|"~     The aim of this study is to determine the effectiveness of a combination of diclofenac and~     lidocaine gel in reducing pain during IUD insertion.~   "
94361|NCT02332044|"~     The purpose of this study is to evaluate the drug-drug interaction between Erdosteine and~     Bepotastine besilate in healthy adult volunteers.~   "
94362|NCT02332031|"~     To evaluate the effect of levothyroxine on the absorption, distribution, metabolization and~     elimination of sorafenib and safety in healthy male subjects~   "
94363|NCT02332018|"~     Evaluation of accuracy and reliability of 2D and 3D measurements of the spine and lower limbs~     in adults based on biplanar radiographs with MicroDose protocol compared to a standard dose~     protocol~   "
94364|NCT02332005|"~     An interventional study to investigate the efficacy and safety of diepalrestat (BNV-222) in~     diabetic patients with diabetic peripheral neuropathy. Subjects will receive twice daily an~     oral dose of diepalrestat, an aldose reductase inhibitor, or placebo to investigate the~     effect on motor nerve conduction velocity (MNCV) and symptomatic clinical responses over 12~     months of treatment. Subjects will be assessed at screening and baseline, with office visits~     every 12 weeks, for a total of 6 visits. The study will explore in a double-blind fashion,~     the effect of two doses of diepalrestat, 150 and 300 mg, to reduce the loss in nerve~     conduction velocity that is expected to be demonstrated in the group randomized to placebo~     treatment for up to 12 months.~   "
94365|NCT02331992|"~     Obstructive Sleep Apnea (OSA) is a common sleep disordered breathing condition effecting~     around 2-4% of the middle aged population and is characterized by periodic collapse of the~     upper airway during sleep. Continuous Positive Airway Pressure (CPAP) is the primary~     treatment for patients with OSA. Despite the effectiveness of CPAP in abolishing upper airway~     obstruction, acceptance of and adherence with therapy has been sub-optimal.~      Over the past decade, considerable research has focused on determining the factors~     responsible for poor CPAP adherence. Two key areas have been identified: patient-reported~     symptoms, including mask discomfort, pressure intolerance and nasal symptoms and the~     importance of patient education and support. In addition we know that the patient experience~     during the crucial first days and weeks of their journey predicts longer term adherence.~      This study investigates the ability of an automated program that assists patients towards~     continuous positive airway pressure (CPAP) therapy adherence.~   "
94366|NCT02331979|"~     This trial will investigate the safety and utility of spinal cord neuromodulation to improve~     urinary bladder function in the context of spinal cord injury.~   "
94367|NCT02331966|"~     The tumors that cause oncogenic osteomalacia (TIO) express and release in the circulation~     phosphaturic factors such as fibroblast growth factor-23 (FGF-23) that decrease renal~     phosphate absorption through acting in the proximal renal tubule and decreasing Type 2a and~     2c sodium-phosphate co-transporter. They typically follow a benign clinical course and even~     in the rare malignant cases, local recurrence occurs in less than 5% and distant metastasis~     are very uncommon.~      In this study we aim to investigate the role of other molecular pathways such as ERK1, ERK2,~     mTOR, EGFR, MEK1, MEK2, VEGFR3, AKT1, AKT2, IGFR-1, IGFR-2, PDGFRA, PDGFRB, cMET, FGFR2,~     apart from FGF23, KLOTHO and PHEX, in the behavior of histopathologically benign mesenchymal~     phosphaturic tumors.~   "
94368|NCT02331953|"~     Postoperative delirium is an important problem in patients undergoing major surgery. The~     incidence of delirium was 12.5% in the patients over 70 years old undergoing spine surgery. A~     study shows that a low preoperative regional cerebral oxygen saturation (rSO2) is associated~     with postoperative delirium after on-pump cardiac surgery. This same perturbation likely also~     increases the risk for postoperative delirium after spine surgery, although there are little~     data that have evaluated this hypothesis. Therefore, this observational study was designed to~     explore the relationship between perioperative rSO2 and the delirium in elderly patients~     undergoing spine surgery.~   "
94369|NCT02331940|"~     The aim of this study was to compare the tiotropium Respimat Soft Mist Inhaler and the~     HandiHaler in terms of their effects on sleeping oxygen saturation (SaO2) and sleep quality~     in patients with COPD.~   "
94370|NCT02331927|"~     The primary objective of the two phase PERMAD trial is the evaluation of the impact of a~     personalized marker-driven treatment approach with early detection of progression and~     modification of treatment on cytokines and angiogenic factors (CAF) and efficacy.~      In regard of the two parts, the primary objective of the run-in phase (n=50 patients) with~     conventional switch of chemotherapy together with the anti-angiogenic agent is the~     determination of a distinct cytokines and angiogenic factor (CAF) profile during treatment~     with FOLFOX and bevacizumab, which allows early detection/prediction of progressive disease.~     The primary objective of the marker-driven randomized part (n=150 patients) with~     marker-driven switch of antiangiogenic agent and maintenance of chemotherapy is the~     evaluation of the efficacy of an early marker-driven switch of anti-angiogenic treatment~     (bevacizumab to aflibercept)~      This is a multicentre, multinational, open labeled, prospective, randomized, controlled phase~     II study designed to assess the clinical utility of an early marker driven change of~     anti-angiogenic treatment (bevacizumab to aflibercept) maintaining the chemotherapy backbone~     until definite radiological progression in first line treatment of patients with metastatic~     colorectal cancer. After completing the run in phase of the study, with at least 30 patients~     completing their first line treatment (due to progression, secondary resection or toxicity)~     and being evaluable for CAF analyses, the results will be reviewed by an Independent Data~     Monitoring Committee (IDMC). Based on that review the decision to continue with, modify or~     cancel the randomized part will be made.~      The primary endpoint of the run-in phase with conventional switch of chemotherapy together~     with the anti-angiogenic agent is:~      • Progression free survival (PFS1) of first line treatment~      The primary endpoint of the randomized part with marker-driven switch of antiangiogenic agent~     and maintenance of chemotherapy is:~      • Progression free survival rate at 6 months (PFSR@6) after first cycle after randomization.~   "
94371|NCT02331914|"~     Gastrointestinal stromal tumors (GISTs) belong to the sarcoma group and are characterized by~     oncogenic mutations in the c-KIT, PDGFRA, BRAF and NF-1 genes that drive tumor growth. Since~     tyrosine kinase inhibitors (TKIs) have become available, the median survival of GIST patients~     increased from 9 months to over 5 years. Consequently, this rare disease has become a role~     model for other targeted therapies. However, response to TKIs is extremely heterogeneous:~     ~15% of the patients experience no benefit from imatinib, whereas ~17% of the patients enjoy~     stable disease for over 9 years. Treatment failure due to primary and secondary resistance is~     caused in part by mutations in oncogenic genes that cause change in drug sensitivity. A new~     technique, using circulating tumor DNA, has enabled us to assess mutations in a simple blood~     sample obtained from patients on treatment, and thus detect new mutations early in the course~     of the disease. Also, differences in pharmacokinetic drug behavior add to the observed~     heterogeneity, and may cause resistance due to drug underexposure and thereby proliferation~     of the least sensitive tumor cells. This offers the opportunity to optimize and personalize~     targeted treatment for individual GIST patients by timely treatment adaptation based on early~     detection of secondary TKIs resistance mutations. Achieving this urgently requires data on~     daily clinical practice, including prospective serial mutation analysis and serial drug~     plasma concentration measurement. At a fundamental level this will also help to unravel the~     driving factors behind primary and secondary TKIs resistance in this model disease.~   "
94372|NCT02331901|"~     This study examine the possible microstructural changes in the middle brain after mTBI using~     diffusion MRI~   "
94373|NCT02331888|"~     Once in labor, the parturient will be connected to the routine fetal doppler and EUM. When~     necessary according to clinical indications, the scalp electrode will be connected. Tracing~     will be recorded simultaneously from all three devices until delivery.~   "
94374|NCT02331875|"~     The primary objective of this open label Phase Ib/II trial is to evaluate the clinical and~     pharmacological activity of IPH2201 as a single-agent in treatment-naïve pre-operative~     patients with operable Squamous Cell Carcinoma of the Oral Cavity .~      43 patients are planned to be enrolled. The first 6 patients will receive IPH2201 at a dose~     of 4 mg/kg q2w x 4. Subsequent patients will be treated at a dose of 10 mg/kg q2w x 4.~     Standard loco-regional treatment with surgery followed by adjuvant therapy will be initiated~     after the last administration of IPH2201.~   "
94375|NCT02331862|"~     Purposes of this study will be as follows:~        1. To design a prospective, randomized, and open-labeled study to investigate the effect~          and the side effect of MPD in combination with conventional antibiotics to affect~          clinical course, outcome, and medical expenses.~        2. To compare level of the urinary and serum cytokines before and after received MPD for~          the following sub-aim:~      I. To determine the population who is benefit from MPD to reduce the severity of clinical~     course and subsequent renal scarring.~      II. To understand the mechanism by which the MPD could shorten the clinical course and reduce~     the renal scarring.~   "
94376|NCT02331849|"~     Esophageal Motility in eosinophilic esophagitis will be evaluated by High Resolution~     Manometry before and after medical treatment - motility is suspected to change/improve after~     therapy.~   "
94377|NCT02331836|"~     Comparison of Endocuff-assisted, Cap-assisted and Standard colonoscopy for assessment of the~     adenoma detection rate (ADR)~   "
94378|NCT02331823|"~     Multi-center, prospective study is performed to investigate the efficacy of new short-course~     regimen for retreatment pulmonary tuberculosis patients.~      To obtain optimized short-course regimen, decrease treatment cost and improve success rate.~   "
94379|NCT02331810|"~     Primary Objective:~      Assess in systemic lupus erythematosus (SLE) patients the effect of SAR113244 on B-cell~     subsets compared to placebo.~      Secondary Objectives:~      Assess in male and female lupus patients after SC single dose of SAR113244 the tolerability~     and safety of SAR113244.~      Assess in male and female lupus patients:~        -  The pharmacokinetics of SAR113244.~        -  The pharmacodynamics of SAR113244 for the following disease parameters:~             -  Safety of Estrogens in Lupus Erythematosus National Assessment Systemic Lupus~               Erythematosus Disease Activity Index (SELENA-SLEDAI) score, British Isles Lupus~               Assessment Group (BILAG) score (if applicable), BILAG-Based Composite Lupus~               Assessment (BICLA) (if applicable), systemic lupus erythematosus responder index~               (if applicable), Lupus-quality of life and Functional Assessment of Chronic Illness~               Therapy-Fatigue, anti-double stranded deoxyribonucleic acid antibody and~               anti-nuclear antibody levels and plasma complement levels (C3, C4), erythrocyte~               sedimentation rate and C-reactive protein.~             -  Peripheral blood B and T cell subsets.~   "
94380|NCT02331797|"~     Minimally invasive surgery is becoming more common in many surgical fields. The wide view of~     endoscope allows for minimally invasive transcanal approach instead of large postauricular~     opening. The investigators conduct this study to compared post operative pain score (by~     Visual Analogue Scales) between conventional microscope lateral placing tympanoplasty and~     endoscopic lateral placing tympanoplasty.~   "
94381|NCT02331784|"~     The primary objective of this study is to evaluate the effects of the experimental treatment~     (cognitive training) further outlined in this protocol on the cognitive abilities (e.g.,~     processing speed, attention, working memory, and executive function), brain functionality,~     functional status and quality of life of individuals with age-related cognitive decline as~     compared to a computer-based active control.~   "
94385|NCT02331732|"~     This trial aims to increase the wellbeing of tuberculosis patients and their adherence to~     medication in Chisinau, The Republic of Moldova. The design is an individually randomised~     controlled trial (RCT) and will involve 400 TB patients during their 'continuation phase' of~     treatment. The trial will have two arms; 200 patients will form the control group and receive~     the standard provision of Directly Observed Treatment (DOT) and 200 will receive Virtually~     Observed Treatment (VOT).~      VOT differs from DOT in that the daily observation of patients taking their medication will~     be observed via internet video messages rather than in-person. Based on a small sample of~     patient interviews we think that for some patients DOT may be a hindrance rather than a help.~     VOT allows patients to take their treatment in the comfort of their home and means they don't~     have to travel to their polyclinic every day.~      There will be a central VOT observation centre where VOT observers will view and respond to~     video messages sent in by patients in the VOT arm. The messages will be sent via an M-Health~     app. The VOT observers will also respond to the patients by sending feedback to the patients.~     The trial duration will depend on the recruitment rate of eligible patients but is expected~     to take 16 months.~   "
94386|NCT02331719|"~     Intracerebral hemorrhage (ICH) is the most severe form of stroke: early mortality is 40%, and~     80%-of survivors are physically disabled with high rates of cognitive impairment and~     depression.~      In an effort to address the issues with conventional treatments, a new integrated systematic~     approach has been developed. This approach utilizes an educational process where specific~     core competencies (pillars) of mapping, navigation, access, optics and automated resection~     have been integrated into a single standardized system to deliver targeted therapy for an~     individual patient based on location and patient factors. This system has demonstrated safety~     and efficacy in oncology patients and is also FDA approved for use in the ICH patient~     population as well.~      This registry will collect data form multiple site that preform the MiSPACE procedure as part~     of clinical care. The intent of this registry is to collect data on the economic impact as~     well as clinical outcomes using the MiSPACE approach with the integrated technology in the~     early treatment of ICH.~   "
94387|NCT02331706|"~     This trial is designed to determine the feasibility of conventional induction chemotherapy,~     IFNand G-CSF mobilized DLI (IFN-DLI) in subjects with relapsed AML and ALL after allo-SCT.~   "
94388|NCT02331693|"~     The purpose of this study is to determine whether autologous T cells bearing chimeric antigen~     receptor that can specifically recognize EGFR overexpressed in tumor cells is safe and~     effective for patients with EGFR-overexpressing malignant glioma.~   "
94389|NCT02331680|"~     This is a study to investigate the efficacy and safety of OPC-41061 by 24-week oral~     administration of OPC-41061 at 15-mg or 30-mg or placebo in patients with chronic renal~     failure who are undergoing hemodialysis or hemodiafiltration and who have daily urine volume~     of at least 500 mL/day.~   "
94390|NCT02331667|"~     The main aim of this intervention study is to test the effect of diet on improvement in~     cognitive performanc in kindergarden children aged 4-6 years. Children will be randomly~     allocated into two groups, one consuming prepared meals with herring or mackerel for four~     months, and one group consuming meals containing meat as a control group.~   "
94391|NCT02331654|"~     Pain represents one of the most common symptoms of Multiple Sclerosis (MS) that can seriously~     affect patient health-related quality of life.~      Central neuropathic pain, the main form of pain in MS patients, represents a significant~     clinical problem, in consideration of its poorly responsiveness to available therapies.~      Direct Current Stimulation (tDCS) is a non-invasive, well-tolerated procedure with an high~     and well documented neuromodulation activity at Central Nervous System (CNS) level. First~     evidences obtained by animal, neurophysiological and clinical studies suggested its potential~     efficacy in neuropathic pain treatment.~      In particular spinal DCS (sDCS) has been proven to modulate Nociceptive Withdrawal Reflex~     (NWR), an objective and sensitive tool to explore pain processing at the Spinal Level and~     recommended by European Federation of Neurological Society (EFNS) to evaluate the analgesic~     effect of treatments. In this order of view the investigators' objective is to investigate~     sDCS efficacy in MS neurophatic pain treatment applying validated clinical scales,~     neurophysiological acquisitions and specific biological marker dosages.~   "
94392|NCT02331641|"~     The performance of multiple minor hepatectomies (MMH) instead of major hepatectomies (MH) in~     patients with colorectal liver metastases (CLM) is object of debate. We build a study, using~     the propensity score matched analysis, to compare the short- and long-term outcome of the tow~     groups of patients.~   "
94393|NCT02331628|"~     Effect of Extracorporeal Shock Wave Therapy on Chronic Neurogenic Heterotopic Ossification in~     Traumatic Brain Injured (TBI) patients~      Chronic Neurogenic Heterotopic Ossification (NHO) - Heterotopic ossification is a well known~     late complication of traumatic brain injury. Extracorporeal Shock Wave Therapy - ESWT- is~     used in various medical situations and is being tested for feasibility of use in TBI~     patients.~   "
94394|NCT02331615|"~     Traumatic brain injury (TBI) particularly affects the frontal lobes and patients often suffer~     from executive dysfunction and behavioral disturbances. These types of injuries often involve~     axonal damage to pre frontal brain areas, which mediate various cognitive and behavioral~     functions. Dorsolateral prefrontal circuit lesions cause executive dysfunction, orbitofrontal~     circuit lesions lead to personality changes characterized by disinhibition and anterior~     cingulate circuit lesions present with apathy. Patients who suffered traumatic frontal lobe~     damage often demonstrate a lasting, profound disturbance of emotional regulation and social~     cognition.~      Weak transcranial direct current stimulation (tDCS) induces persisting excitability changes~     in the human motor cortex. this effect depends on the stimulation polarity and is specific to~     the site of stimulation. Interacting with cortical activity, by means of cortical~     stimulation, can positively affect the short-term cognitive performance and improve the~     rehabilitation potential of neurologic patients. In this respect, preliminary evidence~     suggests that cortical stimulation may play a role in treating aphasia, unilateral neglect,~     and other cognitive disorders.~      Several possible mechanisms can account for the effects of tDCS and other methods on~     cognitive performance. They all reflect the potential of these methods to improve the~     subject's ability to relearn or to acquire new strategies for carrying out behavioral tasks.~     It was also found that Activation of prefrontal cortex by tDCS reduces appetite for risk~     during ambiguous decision making.~      In this tDCS study the investigator uses one anode and one cathode electrode placed over the~     scalp to modulate a particular area of the central nervous system (CNS). The stimulation is~     administered via the neuroConn DC.Stimulator Serial number 0096. The DC-STIMULATOR is a~     micro-processor-controlled constant current source. The DC-STIMULATOR is a CE-certified~     medical device for conducting non-invasive transcranial direct current stimulation (tDCS) on~     people.Electrode positioning is determined according to the International EEG 10-20 System.~   "
94395|NCT02331602|"~     The purpose of this study is to evaluate the antiinflammatory effects of rivaroxaban compared~     with dabigatran in patients with atrial fibrillation.~   "
94398|NCT02331563|"~     A total of 60 adult patients American Society of Anesthesiologists physical status I,II, III~     were randomized to Group B (n = 30) receiving TAP block with 0.25% bupivacaine and Group D (n~     = 30) with 0.5 mcg/kg dexmedetomidine added to 0.25 % bupicavaine followed by general~     anaesthesia. Total local anaesthetic volume was standardised with 20 ml each sides of the~     abdomen. Hemodynamic responses to surgical incision and intraoperative fentanyl consumption~     were noted. Visual analog scale (VAS) scores were assessed on the emergence, at 1, 2, 3, 4,~     5, 6 and 24 h. Time to first rescue analgesic (when VAS ≥4 cm or on demand), duration of~     postoperative analgesia, incidence of postoperative nausea-vomiting were also noted.~   "
94399|NCT02331550|"~     To evaluate the rate of regression and progression of low-grade squamous intraepithelial~     lesion comparing expectant vs. ablative treatment.~   "
94400|NCT02331537|"~     The purpose of this study is to examine if an internet-based exposure therapy is effective in~     reducing excessive worry amongst patients who suffer from this problem.~   "
94401|NCT02331524|"~     There are few studies that demonstrate how to best improve daily activity in people with~     heart failure (HF). Exercise alone has been shown to be ineffective, but other techniques~     such as daily activity feedback with encouragement or health coaching may be helpful. This~     research study will investigate two different treatment approaches for improving daily~     activity: 1) daily activity feedback and encouragement, and 2) health coaching with an~     individualized home exercise program. Both treatment approaches are hypothesized to result in~     improved daily activity compared to a control group.~   "
94402|NCT02331511|"~     The purpose of this study is to determine whether Aspirin or Clopidogrel are effective in the~     prevention of venous obstruction after implantation of cardiac pacemaker or defibrillator.~   "
94403|NCT02331498|"~     A phase I/II study of pazopanib in combination with temozolomide in patients with newly~     diagnosed glioblastoma multiforme after surgery and RT-CT (PAZOGLIO study)~   "
94404|NCT02331485|"~     Aim of the study is to assess the role of negative pressure therapy in the prevention of the~     complication of the laparotomy wound in the high risk patients group.~      Primary outcome: Reduction in wound infection rate by 50%~      Secondary outcome: Reduction of the length of hospital stay Decrease of using abx. for wound~     management Decrease cost of patient treatment~   "
94405|NCT02331472|"~     This study is to evaluate the efficacy of urine biomarker in patients with interstitial~     cystitis/painful bladder syndrome~   "
94406|NCT02331459|"~     Exercise has a beneficial role in geriatric patients categorized as frail. Nevertheless, it~     is not known physical training pattern more beneficial for these patients. The reasons for~     heterogeneity and lack of consistency of the results described by published intervention~     programs may be the diversity of isolated - resistance, endurance or proprioceptive trainings~     - or a combination of them. There are no studies with a combined program of this three kinds~     of physical training.~      The objective of this study is to know if a multicomponent physical training program during~     180 days in dwelling-community frail geriatric patients can improve scores on functional,~     activities of daily living, mood, cognitive and quality of life scales and producing changes~     in blood levels of biological and genetic markers.~   "
94407|NCT02331446|"~     The investigators will do an intervention on four groups of previously sedentary~     post-menopausal women which consists: group 1 - 30 minutes per day of physical protocol;~     group 2 - 50 minutes per day of physical protocol; group 3 - 70 minutes per day of physical~     protocol; group 4 - sedentary control women. The protocol consists of three sessions per week~     of concurrent training (half session with aerobic training and the other part with weight~     training). Inflammatory and oxidative parameters will be analyzed and the investigators~     hypothesized that 90 minutes per week of concurrent training (group 1) will reduce the~     inflammatory parameters and the oxidative stress, and this improvements will be greater so~     much as the longer the sessions (a dose-response effect). The physical activity practiced out~     of the intervention will be controlled by a questionnaire (the commuting and leisure sections~     of the International Physical Activity Questionnaire) and the food intake by a 24-hour food~     recall.~   "
94408|NCT02331433|"~     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of~     APN1125 when administered as single doses to healthy adult subjects.~   "
94409|NCT02331420|"~     To assess the impact of weight loss due to bariatric surgery, as compared to the effect of~     optimal medical therapy alone on endothelial function, subclinical atherosclerosis,~     cardiovascular autonomic function in obese patient affected by type 2 diabetes.The study~     consists in a 2-arm randomized trial, in which patients will be randomly assigned to~     bariatric surgery or optimal medical therapy. Each patient will be studied at baseline (T0)~     and 12 months thereafter (T1).~   "
94410|NCT02331407|"~     Stroke is a leading cause of neurological disability worldwide, often causing significant~     weakening and paresis of the affected arm. National spending on post-stroke rehabilitation is~     project to expand 20% to 35% through 2010. As a new tool for therapists, robotic stroke~     therapy devices have the potential to be a cost-effective device aid to physical therapy and~     enable novel modes of exercise not currently available. While recent studies have shown~     chronic patients benefit from repetitive practice, it is not clear whether they improved via~     a reduction in impairment or increased functional compensation because there is a lack of~     standard treatment and scales to assess rehabilitation efficacy in chronic stroke patients.~     This study aims to reconcile difference performance measurements in robotic rehabilitation to~     assess the outcome of robotic rehabilitation training.~   "
94411|NCT02331394|"~     The current proposal is a feasibility and acceptability study to establish the necessary~     groundwork for more detailed investigations into the role of CH in reducing symptoms and~     improving quality of life in NSCLC patients at the Jewish General Hospital (JGH). A~     standardized and easily administered form of CH will be used, incorporating a carefully~     selected combination of herbs designed to alleviate a range of common symptoms suffered by~     patients with advanced NSCLC.~   "
94412|NCT02331381|"~     The results of this imaging and treatment planning protocol will aid in developing procedures~     for patient localization and future clinical implementation of low-field MRI to confirm~     positioning prior to radiation treatment. Images acquired during this study may aid future~     study design for adaptive planning based on low-field MRI images. Moreover, results of this~     imaging and treatment planning may lead to guidance on optimal use of this novel device.~   "
94413|NCT02331368|"~     Multiple myeloma (MM) is a common incurable blood cancer causing debilitating symptoms-bone~     pain, kidney failure, low blood counts and infection. Chemotherapy outcomes are disappointing~     due to short-term response and long-term toxicities.~        1. Studies showed these patients have weak immune against MM due to the immune checkpoint~          mediated by the PD1/PD-L1 interaction between immune cells and MM. Anti-PD-1 antibody~          (anti-PD1) disrupts this interaction, thus unleashing immune cell function and leading~          to killing of MM cells.~        2. Studies further showed enhancement of this unleash after autologous transplant and~          better MM control by anti-PD1 when used after transplant.~        3. Anti-PD1 has been extensively studied in patients with other cancers. It is very safe~          and effective and has been FDA-approved. Complications are of mild degree and easy to~          manage successfully in out-patient setting. Severe complications are rare.~      Thus, we are proposing an efficacy study of anti-PD1 treatment after transplant to improve MM~     treatment outcomes. This is a collaborative study with Medical College of Wisconsin~     (headquarter of Center for International blood and Marrow Transplant Research). We~     hypothesized that anti-PD1 treatment will increase the MM response and the MM control~     duration when it is added to the standard MM treatment after transplant. Anti-PD1 will be~     given at the dose and interval, which had been studied previously (200 mg intravenous~     injection every 3 weeks) between 2 weeks until 6 months after transplant. Subjects will be~     monitored closely during and after anti-PD1 therapy until at least 1 year post transplant.~     Late complications will be followed until 3 years.~   "
94414|NCT02331355|"~     There is an urgent need to develop hand transplant programs in this country. To this end, the~     University of Michigan Hospital and Health Systems is developing such an interdisciplinary~     program. The Transplant Center would like to track the patient experience from pre-operative~     care through surgery and post-operative care.~      Detailed information will be collected from the patient medical records, including:~     Pre-operative screening, demographics, medications; Surgical information ; Post-operative~     inpatient and out-patient care; laboratory and other test results; physical assessments,~     psychological assessments and quality of life assessments.~   "
94415|NCT02331342|"~     Cardiac output (CO) is an important parameter in the diagnosis and therapy of cardiac~     diseases. The aim of the study at hand was to evaluate NICOM (bioreactance) as a new method~     for determinion of CO and to compare it to Innocor (inert gas rebreathing), which previously~     showed promising results.~   "
94416|NCT02331329|"~     Cardiac output (CO) is an important parameter in the diagnosis and therapy of cardiac~     diseases. The current standard methods for the determination of CO, however, are either~     invasive (e.g. right heart catheterization) or technically expendable and expensive (magnetic~     resonance tomography, MRT). Therefore, the aim of the study at hand was to evaluate NICOM~     (bioreactance) as a new method for determinion of CO and to compare this new technique to~     MRT.~   "
94417|NCT02331316|"~     The purpose of this study is to find out if drinking extra water helps people lose or~     maintain weight loss and reduce hunger and, if so, what volume of water is most effective and~     when is it best to drink it.~   "
94418|NCT02331303|"~     The objective of this study is to evaluate the extent of potential off-label use of Xofigo in~     Sweden.~   "
94419|NCT02331290|"~     This study is designed to determine if changes in acetyl amantadine (AA) metabolism with~     systemic chemotherapy - reflective of SSAT1 activity - are predictive of response to systemic~     therapy in patients with lung cancer. Ten patients with adenocarcinoma and 10 with small-cell~     cancer who are at American Joint Committee on Cancer (AJCC) stages 3 or 4 at the time of~     diagnosis will participate. AA metabolites will be examined by ELISA prior to initiation of~     systemic chemotherapy and after the second cycle of therapy. Changes in the pattern of~     metabolites will be correlated with convention clinical and radiographic response criteria.~   "
94420|NCT02331277|"~     The primary objective of this trial is to investigate the safety and tolerability of multiple~     doses of BI 655064 following weekly subcutaneous injection for 4 weeks in healthy Chinese~     male volunteers.~      The secondary objective is the exploratory evaluation of the pharmacokinetics and~     pharmacodynamics of multiple doses of BI 655064 following weekly subcutaneous injection for 4~     weeks in healthy Chinese male volunteers.~   "
94421|NCT02331264|"~     PRIMARY OBJECTIVE To establish the effect of metal ion release from metal hip implants on~     cardiac function~      STUDY OUTCOME MEASURES~      To assess the effect of metal ions from hip implants on cardiac function as measured by~     Cardiac Magnetic Resonance Imaging (CMR) and Echocardiogram. This involves the surrogate~     detection of cobalt ion deposition within cardiac tissues and assessment of ejection fraction~     and tissue characterization (with and without contrast).~      STUDY IMPACT~      With 60,000 patients having a metal on metal (MOM) hip implant in the United Kingdom (UK),~     and over a million worldwide, there is need to clarify this important question, which is the~     source of significant concern amongst patients and surgeons alike. Also, this problem is not~     unique to MOM hips since all hip implants contain metal and as seen in various case reports~     high blood cobalt levels have arisen after catastrophic failure (e.g. fracture of a ceramic~     bearing surface) leading to abnormal wear of the implant and release of metal ions into the~     body. In the UK, over 80,000 hip implants are inserted annually.~   "
94422|NCT02331251|"~     The Phase Ib and II cohorts will enroll patients with metistatic solid tumors.~      Phase II only will enroll the following patients:~      Patients with metastatic sarcoma to be enrolled in the following 4 arms: pembro plus~     gemcitabine, pembro plus gemcitabine and docetaxel, pembro plus gemcitabine and vinorelbine,~     and pembro plus liposomal doxorubicin.~      Patients with metastatic pancreatic adenocarcinoma to be enrolled in the pembro plus~     gemcitabine and nab-paclitaxel arm.~      Patients with extensive-stage small cell lung cancer to be enrolled in the pembro plus~     irinotecan arm.~      Patients with ER+ breast cancer to be enrolled in the pembro and vinorelbine arm.~      Patients with ovarian cancer to be enrolled in the pembroplus liposomal doxorubicin arm.~      Patients with metastatic TNBC (ER/PR/HER2 negative) to be enrolled in the pembro plus~     gemcitabine arm.~   "
94470|NCT02330627|"~     The proposed project aims to test the efficacy and neural correlates of a behavioral~     treatment program comprised of positive activity interventions in a sample of individuals~     seeking treatment for anxiety or depression. Participants will be randomly assigned to an~     immediate or delayed treatment condition, and will be compared on measures of positive and~     negative emotions, brain responses to reward and punishment/loss, subjective well-being, and~     symptoms at baseline and post-treatment.~   "
94423|NCT02331238|"~     This cluster-randomized school-based study will examine the effectiveness of a program for~     the primary prevention of perpetration of teen dating violence and sexual violence among~     middle school male athletes. Engaging men and boys in preventing violence against women and~     girls is recognized by major global health organizations as a critical public health~     strategy. Coaching Boys into Men is a theory- and evidence based program intended to alter~     gender norms that foster teen dating violence/sexual violence perpetration, promote bystander~     intervention, and reduce teen dating violence/sexual violence perpetration. Coaches receive a~     60-minute training and biweekly check-in from a violence prevention advocate to administer~     the intervention to their athletes via 12 mini-lessons conducted weekly throughout a sport~     season. In a randomized trial of program effectiveness among high school athletes (Centers~     for Disease Control and Prevention CE001561-01, PI Miller), male athletes receiving the~     program demonstrated increased positive bystander intervention behaviors and less verbal~     abuse perpetration compared to controls. This project seeks to test the effectiveness of this~     program with younger male athletes in grades 6-8.The innovations are three-fold: (1) testing~     the efficacy of a novel teen dating violence/sexual violence prevention program for middle~     school male athletes; (2) training athletic coaches in Teen Dating Violence/Sexual Violence~     prevention thus implementing primary prevention that does not rely on teachers or classroom~     time; and (3) integrating the goal of changing gender norms with the technique of a bystander~     intervention approach to reduce teen dating violence/sexual violence prevention. The~     experimental design involves a 2-armed cluster randomized- controlled trial in 41 middle~     schools (38 clusters) in Pennsylvania. Schools will be randomly assigned to either~     intervention or control (standard coaching) condition. Coaches in intervention schools will~     receive Coaching Boys into Men training. Baseline surveys will be collected for all~     intervention and control site athletes entering grades 6-8 at the start of each sports~     seasons across Year 1 (Time 1; N= 973 athletes). Follow up surveys will be collected at the~     end of each sports season (Time 2). All participating athletes will be re-surveyed 12 months~     after baseline (Time 3).~   "
94424|NCT02331225|"~     Systemic sclerosis (SSc, also known as scleroderma) is a disease characterized by fibrosis of~     the skin and organs, inflammation, and an abnormal endothelial cell lining inside of vessels.~     A common and deadly complication of SSc is pulmonary hypertension (PH), which is an abnormal~     elevation in the blood pressure within the lung blood vessels. Early identification and~     treatment of PH is important in SSc, and no clinical factors can predict which patients will~     develop PH with acceptable accuracy. A potential marker of PH in SSc is the presence of~     increased amounts of endothelial microparticles (EMPs), which are substances circulating in~     the blood that were released from damaged vessel wall endothelial lining. A main goal of this~     study is to investigate if there is a difference in EMP levels between SSc patients with and~     without PH. The investigators will also use human endothelial cells in a lab environment to~     test whether these EMPs isolated from SSc patients are actually causing damage to the vessel~     lining. Lastly, the investigators will investigate the potential benefit of a medication used~     after transplant, mycophenolate mofetil (MMF). This will be done by causing damage to~     isolated human endothelial cells and treating them with MMF. The main goal of this portion of~     our study is to see if EMP levels are reduced when cells are treated with MMF. Overall, the~     investigators anticipate the following outcomes of this study: 1) use EMP levels to~     differentiation patients with SSc who have PH from those without PH, 2) use EMPs to~     understand how endothelial damage occurs in SSc, and 3) use EMPs to help us develop new~     treatments for patients with vascular diseases.~   "
94425|NCT02331212|"~     This research trial studies the role of a substance called hyaluronic acid in causing the~     growth of cancer stem cells in the bones of patients with breast cancer. Cancer stem cells~     are a type of cancer cells that may cause the cancer to spread to other parts of the body.~     Studying samples of blood and bone marrow from patients and animal models in the laboratory~     may help doctors learn more about whether hyaluronic acid affects the growth of cancer in the~     bones.~   "
94426|NCT02331199|"~     The investigators will study 200 women with singleton pregnancies presented with prelabor~     preterm rupture of membranes or undergoing cesarean section (CS). Amniotic fluid lamellar~     body count (LBC) and fetal pulmonary artery Doppler will be done to all women. LBC and fetal~     pulmonary artery Doppler will be correlated with fetal outcome~   "
94427|NCT02331186|"~     Urinary incontinence is well documented as a comorbidity of obesity. Studies demonstrate~     improvement of incontinency after weight loss. However, the mechanisms are still not clear.~     Aim of our study to analyze the effects of bariatric surgery on pelvic floor function in~     women.~   "
94428|NCT02331173|"~     The purpose of this study is to evaluate subjects with X-linked retinoschisis in a clinical~     setting to collect data on disease progression.~   "
94429|NCT02331160|"~     Breech presentation occurs in approximately 3-5% of all pregnancies, and breech birth is more~     complicated and risky for the fetus than births of fetuses in the cephalic position.~      Therefore, it is desirable to turn the fetus from breech presentation to cephalic position~     before labour. This is traditionally done by external cephalic version, where the doctor~     manually tries to turn the fetus; the success rate of this is approximately 50%, and~     complications occur in about 0.5%. In addition there is discomfort and pain to the pregnant~     woman.~      The investigators will assess the effect of using the rebozo prior to the external version.~     Use of rebozo is a recognized technique from Mexico, where the midwife with a scarf 'shake'~     the pregnant woman's pelvis over several sessions, so the fetus spontaneously turns to~     cephalic presentation or the external version is facilitated.~      There are no known complications associated with the rebozo method. Use of rebozo in breech~     presentation has never before been studied scientifically, but is used in many places in the~     world. The investigators are planning an open-labeled randomized controlled study in~     pregnancies with verified breech or transverse presentation: by lot either standard external~     cephalic version or preceding rebozo-treatment with subsequent external cephalic version.~      The investigators want to assess whether the use of rebozo - either as pre-treatment for~     external cephalic version or as a catalyst of spontaneous version - will increase the~     incidence of the cephalic presentations at labour and thus reduce the number of planned~     caesarean section.~      The population will be pregnant women with ultrasound verified breech or transverse~     presentation;all women who fulfill the local guideline criteria for external cephalic~     version, can be included. Exclusion criteria are non-Danish speaking or reading.~      The recruitment will be conducted by midwife at week 35 in the antenatal care. The study~     design will be open-labeled randomized controlled. Randomisation is done by closed envelope~     method and stratified by parity. Intervention is rebozo exercises performed over 3-5 days~     from randomization. In case of persistent breech presentation, the woman is offered standard~     external cephalic version. The control group will also be offered external cephalic version~     after 3-5 days from randomization.~      The investigators will use source data from existing local databases, Obstetrics Database~     and version Database, for collecting birth outcome. In all stages of intervention~     documented electronically by project midwives.~      The primary objective is the number of successful versions in total, i.e., after intervention~     and external cephalic version. We expect to increase the success rate from 50% to 65%, thus~     requiring 378 women in the study.~      Secondary objectives are the number of successful vaginal births with birth in head position~     and total number of caesarean.~   "
94430|NCT02331147|"~     This is comparison trial comparing human dermis to standard wound care for non healing~     diabetic wound~   "
94431|NCT02331134|"~     The overall goal of this study is to develop a pre-clinical platform of melanoma and head and~     neck squamous cell cancer that will allow the investigators to learn more about these~     diseases and discover better and more individualized treatments.~   "
94432|NCT02331121|"~     Unintentional injuries are the leading cause of death for children and infants under 14 years~     of age. Many of these deaths are preventable, in part by promoting injury prevention~     behaviors but also by administering effective emergency first aid techniques until advanced~     care arrives. This project created a web site program that paired video-based instruction~     with interactive skills training to teach parents of children birth to 12 years old basic~     first-aid and CPR skills, and that included the option to practice skills as needed.~   "
94433|NCT02331108|"~     To compart differences on the effect on core temperature between anesthetic induction with~     intravenous propofol versus inhalation induction with sevoflurane~   "
94434|NCT02331095|"~     This is a pilot, randomized, open-labelled study. Eligible patients will be enrolled and~     randomized 1:1 into anticoagulation arm or anticoagulation plus atorvastatin arm, with~     atorvastatin given at 40 mg orally daily for 3 months. The targeted total accrual is 80~     patients, with 40 in each arm. Patients will be recruited from the hospitals and clinics at~     The Ohio State University Wexner Medical Center. Follow up visits are planned at enrollment,~     3 months, and 9 months after randomization. At each follow up, blood will be obtained and~     assessments will include structured interviews of signs and symptoms of recurrent venous~     thromboembolism (VTE), bleeding, post thrombotic syndrome, and adverse events from study~     drugs.~   "
94435|NCT02331082|"~     Globally, over seven million children under the age of five die each year, although a suite~     of interventions—safe delivery care, neonatal care and resuscitation, and management of~     childhood diarrhea, malnutrition, and pneumonia—can prevent many of these deaths when~     implemented within functioning health systems. This study will include a quasi experimental,~     stepped wedge, cluster-controlled trial of a mobile health care coordination and quality~     improvement intervention designed to facilitate comprehensive health systems strengthening.~     It will do this through training and equipping community-level health care clinics to manage~     chronic diseases through use of the Chronic Care Model, structured quality improvement~     sessions to promote clinical mentorship, and use of an integrated electronic medical record~     to provide real-time data for disease surveillance. The investigators hypothesize that~     improving upon the health system in these ways will lead to a 25% reduction in under-two~     mortality through improved services for the citizens of Achham, Nepal.~   "
94436|NCT02331069|"~     The posterior antebrachial cutaneous nerve (PACN) can be compressed between the deltoid and~     triceps, with resultant pain and dysfunction. The active treatment for this study will be~     injection of the point of compression and along the painful course of the sensory nerve with~     5% dextrose. The control treatment will be physical therapy.~   "
94437|NCT02331056|"~     There are some risks of pulmonary edema in patients undergoing pulmonary lobectomy with one~     lung ventilation. The overloading of fluid administration could be related to the development~     of pulmonary edema in patents after thoracic surgery. But fluid restriction may cause major~     organ hypoperfusion during the surgery. The purpose of this study is to evaluate the ability~     of stroke volume variation as an indicator for a fluid responsiveness in patient who receives~     pulmonary lobectomy via thoracotomy.~   "
94438|NCT02331043|"~     Efficacy of plant stanols as esters on LDL-cholesterol reduction is well documented.~     LDL-cholesterol lowering efficacy of the ingredient in a biscuit (providing 2 g plant stanols~     as esters per day) is less well known.~   "
94439|NCT02331030|"~     This study evaluates the addition of Pecs II block to ultrasound-guided supraclavicular~     brachial plexus block in patients undergoing arteriovenous graft creation surgery.~     Participants will be randomised into two equal groups, one receiving supraclavicular and pecs~     II blocks, the other receiving supraclavicular block and sham block (Grade 1).~   "
94440|NCT02331017|"~     To evaluate the combination of electric hearing through Cochlear Implant and acoustic hearing~     through hearing aid in bimodal users with moderate-to-severe hearing loss in the~     non-implanted ear. The research will also provide pilot study data on unilateral Cochlear~     Implant recipients with residual useful acoustic hearing in the implanted ear whose acoustic~     hearing has been preserved.~   "
94441|NCT02331004|"~     Investigators have created a protocol of intervention to treating the general disability of~     upper limbs.~   "
94442|NCT02330991|"~     The purpose of this study is to evaluate the clinical benefit and safety of two different~     Dose-Intense temozolomide regimens（one-week on/one-week off regimen versus continuous~     dose-intense regimen）in patients with glioblastoma at first relapse.~   "
94443|NCT02330978|"~     Bone marrow-derived mesenchymal stem cells (MSC) therapy is a promising treatment for several~     degenerative diseases, including retinopathies and glaucoma, however no previous safety study~     involving humans has been conducted. The objective of this study is to evaluate effects of~     autologous bone marrow-derived MSC transplantation in the worst eye of 10 patients with legal~     bilateral blindness due to glaucoma. Primary outcome are types and severity of adverse~     effects. Secondary outcomes are changes in visual field, visual acuity, optical coherence~     tomography, and retinal ganglion cells function.~   "
94444|NCT02330965|"~     The primary goal of this study is to evaluate the effects of BAF312 (siponimod) on select~     immune and neuronal (nerve) cells by examining laboratory specimens (blood and/or spinal~     fluid) at multiple time points, prior to, and following the initiation of BAF312 or placebo~     treatment, in patients with Secondary Progressive Multiple Sclerosis (SPMS) who are enrolled~     in a clinical trial (NCT01665144) to evaluate the effectiveness and safety of BAF312.~   "
94445|NCT02330952|"~     Primary objective:~      The aim of this study is to determine the efficacy and safety of five days of oral~     corticosteroids (40 mg / day) for the treatment of acute exacerbations of COPD (AECOPD) in~     outpatients.~   "
94446|NCT02330939|"~     The purpose of this study is to determine whether dietary fats may affect postprandial~     glycemic response differently according to their quality, and these effects may differ~     whether they are assumed in the context of meals with high or low glycemic index in patients~     with type 1 diabetes. This interaction between quality of fat and glycemic index of~     carbohydrates may have clinical implication for the calculation of prandial insulin dose in~     these patients.~   "
94447|NCT02330926|"~     Cancer cachexia is a multi-factorial syndrome defined by an ongoing loss of skeletal muscle~     mass (with or without loss of fat mass) that cannot be fully reversed by conventional~     nutritional support and leads to progressive functional impairment.~      There is an urgency for improving management, but there is no consensus on the optimal~     treatment for cancer cachexia. Several single therapies for cancer cachexia have been~     examined in clinical trials, with disappointing overall results. As multiple factors are~     responsible for the development of cachexia, it has been argued that optimal cachexia~     interventions should target all components: multimodal therapy for a multimodal problem.~      The overall aim of this study is to early prevent the development of cachexia rather than~     treatment late in the disease trajectory. From a patient perspective a short term effect will~     be to improve physical and psychological function, to reduce symptom burden and to improve~     survival. In other words live a longer and better life during and after chemotherapy. Direct~     effects of the cachexia intervention are expected to be reduction of weight and muscle loss,~     and improved physical activity and quality of life.~   "
94448|NCT02330913|"~     Laparoscopic gastrectomy became a good option for early gastric cancer. Surgical trend is~     gradually changed to totally laparoscopic gastrectomy from laparoscopy-assisted gastrectomy~     requiring mini-laparotomy. Various types of intracorporeal anastomosis have been introduced~     for esophagojejunostomy during total gastrectomy. We invented a novel anastomosis method~     using linear stapler for total gastrectomy. Three procedures (Jejunal resection, esophageal~     resection and closure of common entry hole after anastomosis) was performed with only one~     stapler. Therefore, the novel method is simple and fast. Also, this new technique is better~     economically than previously introduced anastomosis using linear stapler because lesser~     number of stapler is required. We want to demonstrate the feasibility of novel intracorporeal~     anastomosis method during laparoscopic total gastrectomy.~   "
94449|NCT02330900|"~     Evaluation of electromagnetic interference between modern cell phones and contemporary~     implantable cardioverter defibrillators (ICDs)~   "
94450|NCT02330887|"~     In rural Nepal, the major drivers of underutilization of skilled birth attendance are~     poverty, poor social support and inadequate birth planning. Drawing from similar programs~     that have been shown to improve maternal and neonatal outcomes, we have designed a group~     antenatal care program that uses a participatory learning and action process to engage women~     in identifying and solving problems accessing maternity care services and create a supportive~     social network. We plan to test a group antenatal care program that will change antenatal~     care in three major ways: 1) conduct care in a group setting with women matched by~     gestational age, 2) incorporate participatory learning and action, and 3) provide expert and~     facilitated peer counseling.~   "
94451|NCT02330874|"~     In a recent study, which included 845 patients that at the time of ICU discharge had at least~     one risk factor for readmission, the investigators' group developed a new readmission risk~     score in the ICU, Safe Discharge from ICU (SD-ICU), using parameters easily and routinely~     measured in ICU: the Charlson comorbidity (ICC), the TISS-28 (Therapeutic Intervention~     Scoring System - 28), the length of stay in ICU and age. Through ROC curve analysis, the~     investigators found that patients with a score above 14.5 had a high probability of~     readmission.~      The objective of this study is to validate the Safe Discharge from ICU (SD-ICU) score as a~     tool to predict unplanned readmissions to the intensive care unit.~      All adult patients discharged from a 37 bed general ICU from April 2014 to March 2015 will be~     included in the study. The SD-ICU score is routinely calculated at the time of discharge from~     the ICU. Patients will be divided into two groups: those with SD-ICU score> 14.5 (group 1)~     and those with a score equal to or less than 14.5 (group 2). The two groups will be compared~     with respect to the frequency of unplanned readmissions. Stepwise, multivariate logistic~     regression will be used to investigate the association between the risk factors for~     readmission used in SD-ICU score and ICU readmission as outcome.~   "
94452|NCT02330861|"~     Subjects are patients who are planned to do percutaneous coronary intervention for coronary~     stenosis in the left circumflex artery without other stenosis in the left ascending artery~     and the right coronary artery, or a patient with normal coronary artery. Immediately after~     coronary angiography or percutaneous coronary intervention, the investigators will evaluate~     for coronary hemodynamics by distribution of wave intensity which is calcurated by coronary~     pressure and flow velocity with Combowire in each coronary segment. Also, they will assess~     coronary morphology by View It in each coronary segment.~   "
94453|NCT02330848|"~     Proposed is a randomized, controlled, modified Latin square parallel design study with two~     treatment arms to examine walnut consumption effects on diet quality, body composition, and~     markers of cardiovascular risk in adults at risk for diabetes over a 6-month period. A~     modified crossover design (Latin square)27-29 will allow for both paired and unpaired~     analyses.~   "
94454|NCT02330835|"~     This project evaluated a multimedia student behavior management program for school bus~     drivers and school administrators.~   "
94455|NCT02330822|"~     This is a randomized controlled trial with a split mouth design. Patients with an indication~     of lower dental extraction will be asked to join this research project at the Department of~     Oral and Maxillofacial Surgery at University of Damascus Dental School. Each patient whose~     case requires bilateral extraction, one side will serve as an experimental side, whereas the~     other side will serve as a control.~      Participants should have symmetric teeth that need extraction in the lower jaw. Hyaluronic~     acid will be injected following extraction in one of the two sides with random allocation.~      cone-beam computerized tomography (CBCT) images will be taken for each participant~     immediately post-extraction and at six months post-operatively.~   "
94456|NCT02330809|"~     The purpose of this study is to find out if drinking extra water helps people prevent or~     relieve headaches and hunger and, if so, what volume of water is most effective and when is~     it best to drink it?~   "
94457|NCT02330796|"~     A Phase IIA, open-label, multicenter, active-controlled, parallel-group clinical trial~     designed to evaluate the safety and efficacy of two doses of Bucillamine compared with~     low-dose Colchicine in the treatment of patients with acute gout flare.~   "
94458|NCT02330783|"~     There is no standard treatment in patients with renal cell carcinoma that was previously~     treated with VEGF targeted therapies and mTOR inhibitors.So investigators conducted a~     randomized, open-label, multi-center phase II study to compare bevacizumab plus sorafenib~     versus sorafenib for the third-line treatment of patients with Metastatic renal cell~     carcinoma.~   "
94459|NCT02330770|"~     Comparing the reproductive outcomes of intracytoplasmic sperm injection (ICSI) cycles in~     women at risk of ovarian hyperstimulation syndrome (OHSS) subjected to gonadotropin releasing~     hormone (GnRH) antagonist protocol followed by trigger with concomitant GnRH agonist (GnRHa)~     and low-dose human chorionic gonadotropin (HCG) administration (dual trigger), GnRHa trigger~     with single luteal low-dose HCG or GnRHa trigger with multiple luteal low-doses HCG~   "
94460|NCT02330757|"~     Evaluation of endometrial preparation using either hormonal therapy or ovarian stimulation~     prior to frozen-thawed embryo transfer (FET) in patients without polycystic ovarian syndrome~     (PCOS)~   "
94520|NCT02329964|"~     This study is comparing of rocuronium-sugammadex and succinylcholine during LMS surgery that~     is characterized by short operation time, required intense paralysis and ambulatory setting,~     has not been investigated.~   "
95450|NCT02317770|"~     This study compares the effect of nebulized lidocaine and lidocaine spray in patients~     undergoing esophago-gastro-duodenoscopy. The investigators evaluate the success rate of the~     procedure between two methods.~   "
94461|NCT02330744|"~     The purpose of this study is to test the effects of a computerized approach/avoidance~     training (AAT) procedure on behavioral, affective, and brain mechanisms that are important~     for reward sensitivity and well-being in individuals diagnosed with major depression. The~     training procedure is designed to modify automatic approach responses for positive social~     stimuli. The primary aim is to determine the effects of approach/avoidance training on the~     functioning of brain systems during reward processing in individuals diagnosed with major~     depression. A secondary aim will determine whether brain activation patterns following~     approach/avoidance training predict subsequent affective and behavioral responses during~     reward processing. An exploratory aim will test whether completing the approach/avoidance~     training procedure in combination with a brief computer-delivered behavioral activation~     program for depression will produce larger changes in depression symptoms, positive emotions,~     and social relationship functioning from pre- to post-intervention compared to the control~     training procedure.~   "
94462|NCT02330731|"~     AIM: To compare between n-butyl-2-cyanoacrylate, iso-amyl-2-cyanoacrylate and mixture of 72%~     chromated glycerin with hypertonic glucose solution in management of gastric varices.~      METHODS: Ninety patients with gastric varices presented to Endoscopy Unit of Ain Shams~     University Hospital were included. They were randomly allocated into three groups; each group~     included 30 patients treated with intravariceal sclerosant injections in biweekly sessions~     till complete obturation of gastric varices; Group I (n-butyl-2-cyanoacrylate; Histoacryl®),~     Group II (iso-amyl-2-cyanoacrylate; Amcrylate®) and Group III (mixture of 72% chromated~     glycerin; Scleremo® with glucose solution 25%). All the procedures were done electively~     without active bleeding. Recruited patients were followed up for 3 months.~   "
94463|NCT02330718|"~     The purpose of this study is to elucidate the factors which are associated with the diagnosis~     and predict prognosis and therapeutic targets by collecting specimens of tissue sample,~     peripheral blood, and bone marrow aspirates at the time of diagnosis or relapse/refractory in~     patients with malignant hematologic disorders except acute leukemia. This study is eligible~     for patients who are diagnosed with malignant hematologic disorders except acute leukemia or~     who will have diagnostic procedure with suspicion of having hematologic malignancy.~     Prospective cohort is for patients who are not in treatment for hematologic malignancy.~     Retrospective cohort is for patients who are diagnosed and in treatment.~   "
94464|NCT02330705|"~     Evaluation of the effect of altering the timing of human chorionic gonadotropin (HCG)~     administration on the clinical pregnancy rate in intrauterine insemination (IUI) cycles.~   "
94465|NCT02330692|"~     Developing a molecular genetic test that can identify prognostic factors which can predict~     response to treatment, and to contribute to the establishment of future therapeutic~     strategies base on prognostic factors by undergoing peripheral blood and bone marrow~     examination of Myelodysplastic Syndrome (MDS) patients at diagnosis and relapse.~   "
94466|NCT02330679|"~     Despite significant advances in pharmacological treatment, the global burden of depression is~     increasing worldwide. The major challenge in antidepressant treatment is the clinicians'~     inability to predict the variability in individual response to the treatment. The development~     of biomarkers to predict treatment outcomes would enable clinician to find the right~     medication for a particular patient at the early stage of the treatment and thus could reduce~     prolonged suffering and ineffective protracted treatment. Brain imaging studies that examined~     brain predictors of treatment response based on group comparisons have limited value in~     classifying individuals as responders or non-responders. Machine learning classification~     techniques such as the support vector machine (SVM) method have proven useful in the~     classification of individual brain image observations into distinct groups or classes.~     However, studies that have applied the SVM method to structural and functional magnetic~     resonance scans (fMRI) involved small sample sizes and were confounded by placebo responses.~     Furthermore, a recent meta-analysis of clinical trials and EEG studies have shown that early~     clinical responses and brain changes at the early phase of antidepressant treatment may~     predict later clinical outcomes suggesting that neural markers measured in the early phase of~     antidepressant treatment may improve predictive accuracy. However, there is no fMRI study to~     date that has examined the predictive accuracy of data obtained in early phase of the~     treatment. We have preliminary fMRI data relating to early treatment response that form the~     basis of this proposed study.~      The main objective of this study is to use machine learning method to examine the predictive~     value (sensitivity, specificity, accuracy) of resting state and emotional task-related fMRI~     data collected at pre-treatment baseline (week 0) and in the early phase of antidepressant~     treatment (week 2) in the classification of remitters (< 10 MADRS scores after 12 weeks of~     treatment) and non-remitters in patients with major depressive disorder (MDD). A secondary~     objective is to determine which data set (week 0 or week 2) gives the best predictive value.~   "
94467|NCT02330666|"~     Engaging in health-risk behaviors such as tobacco and alcohol use put youth at risk for~     health problems that may compromise their futures and are extremely costly to society.~     Positive parent-child communication, characterized by openness, satisfaction with the family,~     caring, and effective problem-solving, has been found to be protective against a youth's~     involvement in health-risk behaviors. To promote positive adult-youth communication, in~     earlier work we developed, tested, and found efficacious an intervention, Mission Possible:~     Parents and Kids Who Listen (MP). This study is designed to test the following hypotheses:~     (a) Adults and youth who participate in MP will demonstrate more positive communication when~     compared with adults who did not participate; (b) Youth who participate in MP will have a~     lower incidence of health-risk behavior when compared with youth who did not participate; and~     (c) Positive adult-youth communication will mediate childhood health-risk behavior in the~     presence of risk processes that predict participation. The experimental design is a 2-group~     (intervention and comparison) pre-test repeated measures design with six waves of data~     collection over three years and two booster sessions of the intervention. Elementary school~     and community centers in Madison and Chicago served as recruitment sites for parent-child~     dyads.~   "
94468|NCT02330653|"~     The primary aim of this phase I/II, randomized, placebo controlled study is the assessment of~     safety and tolerability of universal donor FMT compared to placebo in pediatric and young~     adult subjects (ages 5 years through 30 years) with active ulcerative colitis (UC) who have~     have failed, are intolerant to, or have refused traditional first-line maintenance therapy.~     Secondary objectives include the identification biomarkers in both donor and recipient that~     may confer a clinical response and to establish whether or not ongoing FMT maintenance~     therapy is required for maintenance of clinical benefit in pediatric UC.~   "
94469|NCT02330640|"~     This study is designed to demonstrate that the onset of the antiplatelet effect of 90mg bid~     dose ticagrelor is more rapid and greater than 75 mg qd dose clopidogrel in patients~     undergoing CABG surgery.~   "
94571|NCT02329301|"~     To quantify the relative effectiveness, cost, and cost-effectiveness of fMDA and MDA with~     DHAp against no mass treatment for reducing P. falciparum parasite prevalence, confirmed OPD~     malaria case incidence and cohort infection incidence in areas of high and low malaria~     transmission and in a program-relevant manner that will permit adoption and adaptation for~     wider-scale deployment.~   "
94471|NCT02330614|"~     128 patients between 18 and 76 years who attended the Operative Dentistry Clinic at Dental~     School, Universidad de Chile, were included in the study. 58 patients were bleaching~     (experimental group) and 70 patients don't accepted the bleaching procedure (control group)~     were included in this study and signed a consent form.Experimental group Patients who agreed~     to be bleaching were treated with 10% carbamide peroxide (CP) gel (Whiteness Perfect, FGM) to~     each subject With verbal instructions for 3 weeks with daily applications of 1 hour according~     to manufacturers indications , before and after this procedure was applied again the NEO-FFI~     personality test form, had 30 minutes to answer it.Control group:Patients who refused to be~     bleached were administered the personality test NEO-FFI, had 30 minutes to answer it.~   "
94472|NCT02330601|"~     The recurrent rate of CBDS in patients with recurrent CBDS is high. It was reported that up~     to 60% of patients had stone recurrence within two years after stone retrieval by ERCP.~     Although EPLBD is useful for for extraction of large CBDS with less operation time and~     mechanical lithotripsy.It is not known whether EPLBD could prevent the recurrence in patients~     with recurrent CBDS.Although Harada et al found that EPLBD might reduce the short-term~     recurrence of CBD stones in patients with previous ES. It is a retrospective study with a~     small sample size (n=94).~      Here a prospective, randomized controlled study including two tertiary centers was designed.~     The aim of this study was to investigate whether EPLBD could reduce the recurrence rate in~     patients with recurrent CBDS.~   "
94473|NCT02330588|"~     Childhood obesity is an urgent public health issue. Roughly one-quarter of Canadian children~     are overweight, putting them at risk for chronic diseases. Because most families access~     health services in primary care, it is an ideal venue for obesity prevention. Specifically,~     programs in primary care can prevent unhealthy weight gain in healthy weight children~     (primary prevention) AND reduce unhealthy weight gain in children who are already overweight~     (secondary prevention). Parents play a key role in children's health, so it is vital to~     include parents in strategies to prevent childhood obesity.~      The following objectives of this study are to: (i) develop a web-based, brief program for~     parents as an educational tool to motivate parents to support healthy lifestyles in children,~     and access community resources and health services that can prevent childhood obesity; (ii)~     assess the acceptability of the program using focus groups with parents, and~     pediatric-focused health care professionals, trainees, and administrators; and (iii) recruit~     parents (n=200) in primary care and collect data at baseline and 1-month follow-up to explore~     if the program led to changes in parents' motivation to support their children's lifestyle~     habits, and families' use of resources and health services to prevent childhood obesity.~      It is hypothesized that the developed screening, brief intervention, and referral to~     treatment (SBIRT) will (i) encourage parents of healthy weight children to seek resources to~     eat healthfully and be physically active to maintain their weight status (primary [1°]~     prevention), and (ii) guide parents of unhealthy weight children to access educational tools~     and community services to reduce their child's obesity and associated health risks (secondary~     [2°] prevention).~      By providing families with tailored feedback, practical educational tools, and information on~     local health services, this research will help to address oft-cited barriers primary care~     clinicians commonly report when providing effective obesity-related health services, and~     encourage family self-management of obesity-related behaviors.~   "
94474|NCT02330575|"~     The purpose of the study is to examine the benefit and specific outcomes of a community-based~     exercise program that is designed to address the needs of individuals who are receiving or~     recovering from cancer treatment.~      Eighty cancer survivors from Edmonton and Calgary will take part in the 24-week long study.~     Survivors will be randomly assigned to one of two groups. The first group will take part in~     an 8-week supervised exercise program followed by 8 weeks of self-directed or home-based~     exercise (early exercise group). The other 40 participants will continue with their normal~     activities for 16 weeks (delayed exercise group). After the 16 week period, participants in~     the delayed exercise group will take part in the 8-week supervised exercise program.~      Exercise sessions will take place at selected YMCAs in Edmonton and Calgary. Exercise~     sessions will be supervised by specially trained exercise specialists who have received~     special training in exercise and cancer.~      Outcomes of the study will include feasibility, physical fitness measures, cancer-related~     symptoms and quality of life.~   "
94475|NCT02330562|"~     This is a Phase 1/2 clinical trial to evaluate a new combination of drugs, marizomib (MRZ)~     and bevacizumab (BEV; Avastin®), for the treatment of WHO Grade IV malignant glioma. The~     study population includes subjects who are in first or second relapse and who have not~     previously received any bevacizumab or other anti-angiogenic agent or proteasome inhibitor~     for treatment of malignant glioma. Phase 1 evaluates the combination of MRZ and BEV, while~     Phase 2 evaluates single-agent MRZ. Part 3 (Phase 2) includes a combination MRZ using~     intra-patient dose escalation, and BEV at a fixed dose.~   "
94476|NCT02330549|"~     A Phase 2a, randomized, double-blind, placebo-controlled, multi-center study of CVC to be~     conducted in approximately 50 adult obese subjects (BMI ≥ 30 kg/m2) with prediabetes or type~     2 diabetes mellitus and suspected NALFD.~   "
94477|NCT02330536|"~     Video-assisted thoracoscopic surgery (VATS) has become a standard technique for addressing~     all types of thoracic pathology. Insufflation of carbon dioxide (CO2) into the operated chest~     cavity could increase lung collapse and improve surgical field view. The actual thoracic~     pressure values may not be identical with the presetting on the insufflator display. This~     overshoot pressure during VATS may compromise cardiac and pulmonary function. The purpose of~     this study is to evaluate the effects of intrathoracic pressure overshoot during two-lung~     ventilation on the hemodynamic and respiratory function and clarify the relative safety of~     two different techniques of insufflation.~   "
94478|NCT02330523|"~     To compare the effectiveness of demineralized freeze-dried bone allograft + cross-linked~     collagen membrane with xenograft + non-cross-linked collagen membrane for posterior~     extraction socket ridge preservation.~   "
94479|NCT02330510|"~     The prevalence of both Alzheimer's Disease (AD) and stroke doubles each decade over 65 years~     old. Both are major causes of dementia, currently estimated to affect 46 million people~     worldwide. The current costs globally are $818 billion. Additionally, in population studies~     elders over 65 years, covert cerebral small vessel disease appears on MRI scans as silent~     lacunar infarcts in 25% as Microbleeds in 10%, and as focal or diffuse 'incidental' white~     matter disease (WMD) in 95%. WMD is extensive in 20%, with a clinical threshold effect around~     10cc2. Small vessel disease is even more common in dementia, often coexisting with AD and~     independently contributing to cognitive decline and progression to dementia. Longitudinal~     imaging using cerebral amyloid labeling opens a new opportunity to understand the~     additive/interactive effects of small vessel disease and AD.~      The design of this study includes recruitment of two cohorts, including Mild Cognitive~     Impairment (MCI) and/or early Alzheimer Disease subjects from memory clinics and subjects~     with strokes/TIA from stroke prevention clinics. Inclusion criteria include the presence of~     moderate/extensive white matter disease, eg. Fazekas score of 2 (with confluent~     peri-ventricular hyperintensities) or Fazekas score of 3, as determined by previous MR or CT,~     > 60 years of age, Mini-Mental Status Exam (MMSE) scores ≥ 20. Subjects will undergo 3T~     structural MRI (including T1, PD/T2, FLAIR, GRE, DTI, ASL, and resting state fMRI), glucose~     PET, amyloid PET (using AV-45 florbetapir) and neuropsychological testing, as well as blood~     sampling. Repeat MR and PET/CT imaging and neuropsychological testing will be conducted at 24~     months. The imaging portion is designed to closely parallel the Alzheimer's Disease~     Neuroimaging Initiative (ADNI) in order to benefit from the availability of both cognitively~     normal controls (NC), MCI and Alzheimer's disease subjects with minimal WMD.~   "
94480|NCT02330497|"~     Advances in conventional imaging (abdominal ultrasound, CT scan, MRI) are so great that~     chance to discover a incidental solid or cystic pancreatic lesion is becoming usual.~     Endocrine tumors have variable malignant potential depending on their size, some malignancy~     for lesions larger than 2 cm and indefinite for a smaller size. The branch-duct like IPMN~     (intraductal papillary mucinous pancreatic tumor) involving the pancreatic secondary ducts~     represent half of pancreatic cystic tumors and may degenerate into 5 to 10% of cases. Signs~     and risk of degeneration are the presence of mural nodules greater than 5 mm and size > 3 cm,~     although the latter criterion is discussed. Mucinous cystadenomas could degenerate between 30~     and 50% of cases even though the role of size is much discussed (<4 cm). The follow-up~     imaging is performed using MRI and endoscopic ultrasonography (EUS). A fine needle aspiration~     for cytology and histology is possible and determination of biological markers is useful. But~     cytology is often unprofitable due to the poor cellular profile of the cystic pancreatic~     tumor. Once the diagnosis of suspected malignancy, the patient should be referred to the~     surgeon for pancreatic resection more or less extensive. But this attitude is facing a~     significant operative risk with up to 30% of morbidity and mortality between 1 and 3 % for~     cephalic resections. Some patients with high post operative risks are inoperable. For these~     reasons, some teams have proposed the destruction of the walls of the cyst under EUS, US or~     CT control by washing with absolute alcohol content of cystic tumor.~      An interesting alternative endoscopic destruction would be the use of radio frequency~     ablation technique (RFA). RFA is a recognized technique for local tumor destruction by~     delivering thermal energy to obtain coagulation necrosis of the lesion. Taewong Medical ™~     recently developed a radiofrequency needle EUSRA® coupled with a combo VIVA ™ generator for~     applying RFA sub EUS control. But no prospective study is available at this date regarding~     the treatment of the cystic or solid tumoral pancreatic lesion with this technique. The~     primary endpoint of the present study is to investigate the feasibility and safety of this~     guided radiofrequency probe EUS for the treatment of pancreatic endocrine tumors or~     inoperable pancreatic cystic tumors. The secondary objective will be the efficiency.~   "
94481|NCT02330484|"~     Based on patients' HbA1c improvement, this study aims to establish an incentive strategy to~     family physicians and patients respectively to evaluate the affect on the adherence to~     medication among patients with type2 diabetes.~   "
94482|NCT02330471|"~     In a randomized clinical trial of 120 women undergoing large loop excision of the~     transformation zone (LLETZ)-conization for cervical dysplasia, two coagulation modes, spray~     versus forced coagulation, will be compared. The primary outcome of the study is time to~     complete hemostasis, secondary outcomes are intraoperative blood loss, postoperative pain,~     and postoperative bleeding complications.~   "
94483|NCT02330458|"~     Goal is to prospectively determine if stool calprotectin and change in bowel wall thickness~     and hyperemia, as seen on small bowel ultrasound, at week 0, 14, and 54 can be used to~     predict response at week 54 to infliximab in pediatric patients with small bowel Crohn's~     Disease.~   "
94484|NCT02330445|"~     Part A Primary Objective To determine the safety of six months of PRTX-100 administration.~     Part B Primary Objective To obtain antisera from normal volunteers that have developed~     anti-PRTX-100 antibodies.~      Secondary Objective(s) To assess rheumatoid arthritis activity during the period of PRTX-100~     treatment To evaluate the development of anti-PRTX-100 antibodies To explore feasibility of~     joint evaluations with ultrasound To explore feasibility of biomarkers as disease markers~   "
94485|NCT02330432|"~     Recent evidence suggests that sepsis continuum includes an immune paralytic state, which may~     play a significant role in sepsis. Mycobacterium w by its TLR4 agonist activity may help in~     restoring immunity, thereby improving outcomes in patients with severe sepsis.~      In this randomized trial, the investigators propose to evaluate the efficacy of Mw in~     patients with severe sepsis.~   "
94486|NCT02330419|"~     This is a double-blind, placebo-controlled trial of 120 binge-drinking MSM to 12 weeks of~     naltrexone 50mg, to be taken in anticipation of heavy drinking. Ethnically and racially~     diverse participants will be recruited using Respondent Driven Sampling as well as active~     field recruitment. MSM will be seen weekly for alcohol-metabolite urine testing, study drug~     dispensing, and brief counseling for alcohol use. Safety assessments and behavioral surveys~     will be completed monthly.~   "
94487|NCT02330406|"~     The purpose of this study is to determine whether Anagliptin or Sitagliptin are effective in~     reducing the low-density lipoprotein cholesterol in patients with type 2 diabetes and~     cardiovascular risk factors on statin.~   "
94488|NCT02330380|"~     This is a prospective longitudinal observational pilot study of psoriasis patients on~     continuous standard-of-care systemic therapeutics to determine the level of change in~     established (plasma/serum) and investigative (cellular) biomarkers that are associated with~     increased risk of CVD events.~      The final endpoint of the proposed study will be a ranking of the examined biomarkers based~     upon an integrated assessment of biomarker behavior over time.~      Secondary outcomes will assess changes in coronary artery calcification scoring, PET-MRI,~     skin biopsies, and clinical improvement.~   "
94489|NCT02330367|"~     AC0010 is a novel, potent, small molecule irreversible tyrosine kinase inhibitor (TKI) that~     selectively targets mutant forms of the epidermal growth factor receptor (EGFR) while sparing~     wild-type (WT) EGFR. The purpose of the study is to evaluate the pharmacokinetic (PK) and~     safety profile of oral AC0010; to determine the maximum tolerated dose (MTD) and/or~     recommended Phase 2 dose (RP2D) of oral AC0010; to assess the safety and efficacy of AC0010~     in previously treated mutant EGFR in NSCLC patients with EGFR T790M mutation.~   "
94490|NCT02330354|"~     The purpose of this study is to evaluate the effect of a 7-month social marketing program -~     Healthy Me, Healthy We (previously called Our Year of Healthy Living) - in improving~     preschool children's (3-4 years) diet and physical activity behavior. Healthy Me, Healthy We~     will use social marketing approaches in the child care center to promote the use of healthy~     diet and physical activity behaviors by children, as well as their teachers and parents. The~     program will use visual cues, educational materials, activities, and a song to deliver~     targeted healthy behavior messages that connect the teacher, child, and parents. Centers will~     implement the Our Year of Healthy Living program in their classrooms over the course of a~     school year (October-April). Prior to initiation and after completion of the program,~     researchers will collect information about diet, physical activity, child body mass index~     (BMI), and center and home environment information from participants. From the beginning of~     the program to the end, children enrolled in the program will have 1) a greater increase in~     physical activity and decrease in sedentary time, 2) improved diet, and 3) smaller increase~     in body mass index compared to children in centers that do not complete the program.~     Additionally, from the beginning of the program to the end, homes and centers that~     participate in the program will have greater improvements in scores on the home and center~     environment assessments compared to centers and homes that do not participate.~   "
95553|NCT02316431|"~     Diagnostic accuracy of PET/magnetic resonance and PET/CT will be compared concerning primary~     tumor, regional nodes, metastasis (TNM) staging and therapeutic influence. Workflow scenarios~     will be evaluated to create imaging protocols which are time efficient and diagnostically~     accurate.~   "
94491|NCT02330341|"~     The term prediabetes has been used to encompass the first alterations on glucose metabolism~     such as impaired fasting glucose and glucose intolerance, and its early detection and~     treatment could prevent the appearance of diabetes mellitus type 2, a high prevalence disease~     worldwide.~      Artemisia dracunculus, also known as estragon, has been used in Ayurvedic medicine for the~     treatment of diabetes.~      Different in vitro and in vivo studies have shown that Artemisia dracunculus increases~     insulin signaling and improves insulin sensitivity.~      The aim of this study is evaluate the effect of Artemisia dracunculus on glucose intolerance,~     insulin sensitivity and insulin secretion.~   "
94492|NCT02330328|"~     This is a randomized controlled, multi-center, non-blinded non-inferiority study examining~     the utility of telemetry monitoring in patients admitted who are low risk for acute coronary~     syndrome. Each of the six sites will prospectively enroll 250 patients in each arm of the~     study randomized to either a med-surg bed (no telemetry) or a telemetry bed during their~     admission. Research study coordinators will enroll patients and then follow them throughout~     their hospital course and record primary and secondary end point events.~      The research coordinators will collect information on the following items for data~     collection: age, gender, smoking history, history of hypertension, history of diabetes~     mellitus, history of hypercholesterolemia, and history of family member with early heart~     disease or myocardial infarction, and body mass index. Research coordinators will document if~     the patient had any of the following events during their hospital course: death, myocardial~     infarction (MI), upgrade to a higher level of care, dysrhythmia, results of any stress~     testing or cardiac catheterization. In addition patients will be contacted at 30 days and 365~     days to inquire about MI, needing for percutaneous coronary intervention (PCI), or~     revascularization (CABG).~      Based on previous studies, we hypothesize that patients aged 18-49 years who are at low risk~     for Acute Coronary Syndrome (ACS) are unlikely to benefit from continuous heart monitoring~     while admitted to the hospital for chest pain. We suspect that the rate of significant events~     may approach zero in this group of participants. This study aim is to show that a bed without~     remote monitoring- telemetry- is adequate when these low risk participants with chest pain~     are hospitalized.~   "
94493|NCT02330315|"~     The purpose of this study is to investigate the effects of transcranial direct current~     stimulation (tDCS) in conjunction with transcranial ultrasound (TUS) on pain perception and~     functional limitations in people with osteoarthritis of the knee. The investigators~     hypothesize that there will be a decrease in pain levels with active stimulation, when~     compared to sham stimulation.~   "
94494|NCT02330302|"~     Hip fractures are common in our elderly population and is associated with pain before and~     after surgery. The current pain management for patients who have undergone surgery for hip~     fractures include a combination of oral painkillers, opioids (eg morphine) and regional~     anaesthesia techniques, which involves the injection of local anaesthetic drugs near nerves~     supplying the hip joint to numb the operation site. As opioids have many side effects,~     especially in the elderly patients, regional anaesthesia techniques can help to reduce the~     use of opioids and the related side effects. This may enhance their recovery and length of~     hospital stay~   "
94495|NCT02330289|"~     Studies suggest that some laboratory tests ordered for hospitalized patients are duplicative~     or have limited value. This study will evaluate a normative feedback intervention to reduce~     overuse of laboratory tests for hospitalized patients by internal medicine~     physicians-in-training.~   "
94496|NCT02330276|"~     Early Phase Pre-Clinical and Initial Clinical Research on (+)- Epicatechin.~   "
94497|NCT02330263|"~     Surgical stress creates a state of insulin resistance which has been related to increased~     postoperative complications. Fasting before surgery induces a catabolic state that~     contributes to the development of insulin resistance. The aim of this study is to evaluate~     the effect of preoperative oral carbohydrates on postoperative insulin resistance in patients~     undergoing OPCAB (off-pump coronary artery bypass surgery). Sixty patients, aged 20 to 79~     years, scheduled for OPCAB will be divided into carbohydrate (n=30) and control (n=30)~     groups. Randomly selected patients of the carbohydrate group are given 400ml of 12.8 g/100 ml~     carbohydrate beverage in the evening before surgery and in the morning of the operation day~     (3 hours before their scheduled operation). In contrast, patients in the control group~     consume no food or drink after midnight before their surgery. The primary endpoints are~     postoperative insulin resistance measured by short insulin tolerance test.~   "
94498|NCT02330250|"~     This project aims to improve adherence rate through pharmaceutical care in patients with~     systemic lupus erythematosus (SLE) to help achieving therapeutic goals and finally to improve~     the quality of life of these patients.~   "
94499|NCT02330237|"~     The aim of the study is to evaluate the safety and the therapeutic activity of the~     combination of Natural Gel combination and hair mask of plant origin in patients with mild to~     moderate plaque psoriasis.~   "
94500|NCT02330224|"~     High blood pressure (BP) is a serious public health problem responsible for heart attack,~     stroke and kidney failure. One in four adults in Singapore has hypertension. We propose a~     pilot study in 2 polyclinics in Singapore, 1 deliver a structured multi-component~     intervention and another usual care. A total of 100 adults with uncontrolled high blood~     pressure will be followed for 3 months. The intervention includes 1) algorithm-driven~     antihypertensive treatment for all patients using fixed-dose combination and lipid lowering~     for high risk patients, 2) motivational conversation for high risk patients; and 3) telephone~     based follow-ups of all patients by a team of physician supervised nurse practitioners and~     nurses. The change in BP will be compared between intervention and control groups. The~     structured care including the above mentioned components is likely to be more effective than~     usual care in lowering BP levels of patients with uncontrolled high blood pressure. Such a~     program is also likely to be more cost effective in terms of money spent for improving~     quality of patients' life. The findings of the pilot will inform the design of a larger~     cluster randomized trial in eight polyclinics in Singapore. If the main study is successful,~     the findings will be informative for policymakers to roll out intervention in all polyclinics~     and primary care centers across Singapore, and other countries with similar healthcare~     infrastructure.~   "
94591|NCT02329041|"~     Previous study showed that McGrath Series 5 videolaryngoscope is an alternative tool for~     double-lumen tube intubation. We have compared it with traditional Macintosh laryngoscopefor~     double-lumen tube intubation. In this study, we will investigate its role in double-lumen~     tube intubation by comparison with another videolarygoscope.~   "
94501|NCT02330211|"~     The primary aim of this phase I/II, randomized, placebo controlled study is the assessment of~     safety and tolerability of universal donor FMT compared to placebo in pediatric and young~     adult subjects (ages 5 years through 30 years) with active Crohn's colitis (CD) who have~     failed, are intolerant to, or have refused traditional first-line maintenance therapy.~     Secondary objectives include the identification biomarkers in both donor and recipient that~     may confer a clinical response and to establish whether or not ongoing FMT maintenance~     therapy is required for maintenance of clinical benefit in pediatric CD.~   "
94502|NCT02330198|"~     The purpose of this study is to validate the Foot and Ankle Ability Measure in Finnish.~   "
94503|NCT02330185|"~     The most used anatomical landmark for application of spinal anesthesia is Tuffier's line.~     Other alternative landmark is tenth rib. However there is no trial that compare these~     landmarks based on using ultrasonography.~   "
94504|NCT02330172|"~     This study aims to make a comparison of surgical condition and recovery time between~     rocuronium 0.45 mg/kg and neostigmine group and rocuronium 0.9 mg/kg and sugammadex group.~   "
94505|NCT02330159|"~     Pilonidal disease (PD) is a chronic disease with a major impact on patient quality of life~     and productivity. Thus, wound healing would have a significant effect on patient quality~     outcomes, patient quality of life, and healthcare utilization, as well as societal benefits~     from allowing this vital population to return to productivity. There is no consensus on~     postoperative wound care after surgery for PD. Negative pressure therapy is commonly used.~     However, this therapy is costly and cumbersome, and not evidence-based to optimize wound~     healing or postoperative patient or financial outcomes. The investigators goal is to~     investigate the impact of MatriStem® Wound Matrix and MicroMatrix® (ACell, Inc., Columbia,~     MD) on pilonidal wound healing. Secondary goals are to evaluate the impact of MatriStem Wound~     Matrix and MicroMatrix on postoperative outcomes, quality of life, and healthcare costs after~     surgical management of pilonidal disease.~   "
94506|NCT02330146|"~     The primary purpose of this study is to assess the safety profile of RCT-01 injections as~     compared to placebo injections. This study will also measure the impact these injections will~     have on tendon structure and function and the symptoms of Achilles tendinosis.~      28 participants will be selected for this study based on their health status, current/past~     medications, and ability to adhere to protocol-related requirements. Prior to entering the~     screening phase of the study, all potential study participants will have had to have at least~     3 months of therapy for their unilateral, chronic (symptoms >6 months) Achilles tendinosis~     directed by a certified physiotherapist without a clinical response. At the first visit and~     after providing informed consent participants are evaluated against the study~     inclusion/exclusion criteria and provide blood samples for screening assessments (including~     virology). If suitable for study participation, participants will provide a biopsy from the~     scalp from which RCT-01 will be prepared.~      Baseline evaluations of participants' overall health and tendinosis, in particular, will be~     performed on the day of injection. Once all baseline assessments have been completed, the~     tendon to be treated will be anesthetized and will receive ultrasound-guided injections of~     either placebo (cryomedium) or RCT-01.~      All participants will return to the clinic for repeat assessments of their unilateral~     Achilles tendinosis and overall health at seven (7) visits over the following 6 months.~     Participants will also complete an eccentric training physiotherapy program under the~     guidance of a certified physiotherapist for two (2) months after receipt of injections. Total~     duration of patient participation is approximately eight (8) months.~   "
94507|NCT02330133|"~     Mid-life women, aged 35-50, are currently an underserved population in the areas of~     unintended pregnancy and STI prevention interventions. Common perception is that women in~     this age range are no longer sexually active, or are past the menopause transition, but in~     reality, sexual activity remains stable through mid-life and into the post-menopausal years.~     Additionally, physiological and relationship status changes (e.g. divorce or death of a~     partner) put these women at increased risk for both unintended pregnancy and STI's. This~     project developed and evaluated a theoretically-based multimedia intervention designed to~     assist mid-life women in protecting themselves from sexually transmitted infections and~     unintended pregnancy.~   "
94508|NCT02330120|"~     The aim of this study is to compare the effects of dexmedetomidine and propofol on pulmonary~     mechanics in intensive care patients.~   "
94509|NCT02330107|"~     Lower urinary tract symptoms (LUTS) represent a widespread health problem that negatively~     affects the quality of life (QoL) of majority of the male aging population. Although LUTS are~     not life threatening, these symptoms include urinary retention, voiding difficulty, frequent~     feeling of urinary urgency, and nocturia, all of which negatively affect the daily functions,~     sleep quality, and sexual activities of patients. Despite the proven effectiveness of~     conventional pharmacological therapies, most men are reluctant to try these treatments~     because of perceived side effects and potential complications. Other non-invasive~     complementary treatments for LUTS should be explored because of the limitations of~     pharmacological therapy.~      Auriculotherapy (AT), one of the approaches in traditional Chinese medicine, is a therapeutic~     method in which specific points in the auricle are stimulated to treat various physical~     disorders. AT is a specialized form of acupuncture in which the ear is viewed as a~     microsystem of the body. A minimally invasive measure of AT, instead of using needles, is~     adopted in this study to avoid pain induction.~      This randomized controlled trial (RCT) aims to determine the effectiveness of AT in improving~     the conditions of the elderly with LUTS in terms of symptom relief, enhancing QoL, and~     improving sleep conditions. Male subjects, who are 60 years old or above and with moderate to~     severe LUTS, will be recruited.~      Subjects in 'Treatment arm 1' will receive MAT and placebo LA on specific auricular points on~     one side of the ear during each treatment session. Subjects in 'Treatment arm 2' will receive~     LA and placebo MAT using low-energy laser applied to selected acupoints of the ear, and a~     plaster centred with a portion of Junci Medulla that mimics MAT treatment will also be given.~     Subjects in 'Treatment arm 3' will receive a combined approach (both MAT and LA). Subjects in~     the 'placebo arm' will serve as placebo controls. Six auricular acupoints that are considered~     to affect LUTS will be selected. Only one ear at a time will receive treatment. Thus, the~     ears will be treated alternately. The total treatment period will be four weeks. The~     experimental objects will be replaced every other day. Therefore, treatment will be performed~     thrice a week. Subjects will be assessed at baseline up to 3 months after the therapy. This~     study can advance our knowledge of complementary approaches to improve the LUTS conditions of~     the elderly population and the feasibility of AT among clients with LUTS in a future~     large-scale study.~   "
94510|NCT02330094|"~     The purpose of this study is to see how much gabapentin will reduce headaches associated with~     subarachnoid hemorrhage (SAH) and to reduce the amount of narcotic pain medication~     prescribed.~   "
94547|NCT02329613|"~     The main objective of this study was to evaluate and compare 6-month calorie intakes between~     a group of patients receiving a standard dinner and a group of patients whose evening meal is~     improved; compliance will be assessed on a food card with 5 levels of consumption: no (0%),~     25%, 50%, 75%, all (100%). This per patient per meal food card will be prepared 3 days per~     month for 6 months and will, from the total calorie intake of each dish, estimate calorie~     intake ingested per day on all meals of the day.~   "
94511|NCT02330081|"~     A total of twelve healthy volunteers will donate one unit of fresh whole blood. This unit~     will be treated with the Mirasol Pathogen Reduction Technology for Whole blood and then~     stored for 24h. At the end of storage, platelet concentrates will be separated from the unit,~     tested for key in vitro parameters and radiolabeled. On the same day (so 24h after the~     donation of whole blood), the volunteer will donate a fresh sample of whole blood. Platelets~     will be separated from this fresh sample and labeled with another radio-isotope. Then, the~     two radiolabeled platelet aliquots will be infused simultaneously and the recovery and~     survival of the two types of platelets will be measured.~   "
94512|NCT02330068|"~     The purpose of this study is to evaluate the feasibility of developing a microbiome probe of~     depression and to evaluate the microbiome change in a preliminary analysis of treatment~     response (n=20) vs. non response (n=20) to the antidepressant citalopram. This study is a 12~     week open trial that will enroll approximately 80 participants (anticipated 40 study~     completers with paired biomarker data) with an episode of major depression, Bipolar I or~     Bipolar II and 40 age- and sex-matched healthy controls.~   "
94513|NCT02330055|"~     The primary aim of the study is to evaluate the effect of the method of delivery (vaginal~     delivery vs. cesarean section) on oxygen saturation in the first postpartum night. The~     investigators hypothesize that nocturnal desaturation occurs more frequently in cesarean~     section compared with vaginal delivery, expressed as either the duration of SpO2 below 90% or~     the Oxygen Desaturation Index (ODI). The ODI is defined as number of oxygen desaturations by~     at least 3 % per hour. Furthermore, the investigators expect a higher pulse rate and a lower~     mean and minimum SpO2 in the cesarean section group compared with the vaginal delivery group.~      The secondary aim of the study is to investigate how the upper body position during sleep (45~     degree elevated vs. non-elevated) affects the oxygen saturation during the first postpartum~     night.~      The investigators hypothesize that an upper body elevation to 45 degrees decreases the~     incidence of desaturation events, expressed as either the duration of SpO2 below 90% or the~     ODI , compared with a non-elevated body position within each delivery group (vaginal delivery~     or cesarean section).~      The third aim of the study is to identify independent predictors of nocturnal desaturation in~     postpartum women. To that end, the investigators will administer questionnaires and collect~     demographic and clinical data according to various obstructive sleep apnea screening scores,~     including the P-SAP, STOP-Bang, and Epworth Sleepiness Scale. The investigators will also ask~     the patient to rate the pain during the study night on a verbal numerical rating scale.~   "
94514|NCT02330042|"~     Diabetic retinopathy (DR) is caused by changes in the blood vessels of the retina associated~     with long-term Type 1 or Type 2 diabetes mellitus. DR is a leading cause of blindness in the~     United States. Standard optical coherence tomography (OCT) cannot directly detect vascular~     changes, which may occur early affecting the passage of blood through the tiny capillaries~     (reduced capillary flow) or cause the greatest damage through formation of abnormal blood~     vessel growth (neovascularization). Currently, fluorescein angiography (FA) is the gold~     standard for detecting these changes, but FA requires an injection of a dye into the vein of~     the arm of the patient. This dye can cause undesirable side effects. Recently, OCT has been~     used to make functional measurements (such as total retinal blood flow among others) and to~     perform angiography. Thus, functional OCT may provide a useful, alternate way to evaluate~     diabetic retinopathy.~   "
94515|NCT02330029|"~     The purpose of this study is to test the onset of action, offset of action, efficacy, and~     safety of pinaverium and an herbal medication for irritable bowel syndrome (IBS) for a long~     term (over one year). Pinaverium has been in many countries, but there is no randomized,~     double-blind, large sample size, and placebo-controlled study on this medication yet. Tong~     Xie Yao Fang (Formula for pain and diarrhea) is a historically and contemporarily used~     traditional Chinese medicine that can be used for IBS. The hypothesis is that the two~     remedies are effective and safe for IBS treatment with no significant different onset and~     offset of actions when tested by modern clinical standards and criteria.~   "
94516|NCT02330016|"~     This is a single center study of the safety and efficacy of Juvedérm Voluma for the treatment~     of hypognathism.~      Each qualified subject will undergo treatment with Juvedérm Voluma in the anterior and~     lateral chin for volume correction. Prior to treatment, the principal investigator will~     evaluate the severity of chin recession using a 90 degree image and a goniometer to measure~     the angle from the glabella to the chin. Subjects will be eligible for injection if the angle~     measures between 145 - 160 degrees. Facial digital photography will be captured prior to~     treatment and at each subsequent visit. The subject will complete a safety and injection site~     response (ISR) diary beginning on the evening of treatment.~      The subject will return at Day 3 and Day 14 after initial treatment, at which time the~     subject will undergo photography and the investigator will rate treatment improvement (GAIS).~     An independent image analysis technician will assess the degree of correction. The~     investigator will evaluate the treatment area for any adverse events (AEs).~      The subject will return 30 days after initial treatment, and the principal investigator will~     determine if a touch-up treatment is warranted. If deemed necessary, a touch-up treatment may~     be administered. Facial digital photography will be captured prior to treatment and following~     treatment. The subject will return 3 days after the touch-up to undergo digital photography~     and for the principal investigator to assess safety/improvement.~      After initial or touch-up treatment, whichever is last, routine follow-up visits for safety~     and effectiveness will occur at 1 (30 days), 2, 4, 6, 9 (telephone call only) and 12 months.~     At all follow-up visits, facial digital photography will be captured and the investigator~     will rate treatment improvement (GAIS).. At screening and at Months 1, 2, 4, 6 and month 12~     subjects will complete the satisfaction of face overall module of the FACE-Q questionnaire.~      The goal of this study will be to assess the feasibility of Voluma XC for the treatment of~     hypoplastic chins~   "
94517|NCT02330003|"~     The purpose of this study to evaluate the safety of IL-YANG Inactivated Split Influenza~     Vaccine (IL-YANG FLU Vaccine Prefilled Syringe INJ.) in comparison with Fluarix Prefilled~     Syringe (inactivated split influenza vaccine) after single-dose intramuscular administration.~   "
94518|NCT02329990|"~     Phosphorus is a mineral that is naturally present in our foods and is required by our bodies~     for normal function. It has been found that phosphorus supplementation taken before meals has~     the potential to reduce meal size. However its long term effect has not been measured yet. It~     is well accepted that changes in body weight require about 3 months. Using body weight as the~     outcome, which is the ultimate outcome of weight loss approaches, would provide robust~     information on the role of phosphorus.~   "
94519|NCT02329977|"~     ERCP is the primary choice for removal of common bile duct stone (CBDS) currently. However,~     4-24% patients underwent recurrence after successful clearance of CBDS. Stone re-formation~     due to chronic inflammation of biliary duct is generally considered an important cause of~     CBDS recurrence, which is associated with duodenal-biliary reflux (DBR) after sphincterotomy.~     Although it was believed that DBR was the important cause of CBDS recurrence, the direct~     evidence was still lacking. Here we conducted a case control study to investigate the DBR~     rate in patients with recurrent CBDS after ERCP.~   "
94521|NCT02329951|"~     In this study, we are attempting to determine which factors are associated with~     interventional treatment outcome for LBP (and to what extent). Up to 346 patients with LBP~     who are considered to be good candidates for therapeutic interventional procedures will be~     given a complete history and physical exam, which includes the assessment of Waddell signs,~     and querying them regarding factors shown in non-interventional studies or retrospective~     studies evaluating interventional treatments to be associated with negative treatment~     outcomes. These factors include the presence of Waddell and other physical exam signs, opioid~     use, allergies, psychopathology, concomitant pain conditions, a 6-point Likert scale on~     expectations, sleep abnormalities, secondary gain (e.g. medical board or litigation),~     procedure-related pain, obesity, and smoking history. They will then proceed to undergo their~     scheduled intervention, which will be limited to epidural steroid injections (ESI), facet~     blocks and if positive, radiofrequency denervation, and sacroiliac (SI) joint injections. A~     positive outcome will be defined as > 50% pain relief based on average pain score at 1-month~     and a score of at least 4 on a 1-5 Likert satisfaction scale. Those with a positive outcome~     at 1-month will remain in the study and be followed again at 3-months.~   "
94522|NCT02329938|"~     Unlike Lichtenstein tension free repair for inguinal hernia, Desarda's repair was introduced~     as a pure tissue repair with no need for mesh. In other words; the complications which may~     arise from the use of a foreign body (mesh) will be avoided. The idea was to evaluate the~     efficacy of this new repair and compare it to the standard Lichtenstein repair.~   "
94523|NCT02329925|"~     The coordination of swallowing and breathing is an important mechanism because the route for~     air and deglutition is partly shared in the pharynx. Tongue Stabilizing Device (TSD) is a~     preformed appliance for Obstructive Sleep Apnea (OSA) that protrudes the tongue and improves~     upper airway structure and function during sleep. Investigators will attempt to assess~     efficacy of TSD therapy on OSA and the physiological change of swallowing and breathing~     routes in OSA patients during sleep.~   "
94524|NCT02329912|"~     Postoperative ileus (POI) is a frequent complication after abdominal surgery leading to~     nausea, vomiting and infectious complications. Bowel dysmotility can last for days and~     necessitates parenteral nutrition resulting in an prolonged hospital stay and a high economic~     burden.~      Until now there is no evidence based therapy of manifest POI because of missing valid~     surrogate markers demonstrating the severity and resolution of POI.~      A novel tool to examine gastrointestinal function is the SmartPill®. By measuring pH value,~     temperature and intraluminal pressure the capsule is able to analyse gastric emptying, small~     bowel transit, large bowel transit and peristaltic activity.~      Unfortunately the use of the SmartPill® is not allowed in the first three months after~     abdominal surgery. Therefore a trial is needed to investigate the behaviour of the SmartPill®~     during its passage through the human gastrointestinal tract immediately after surgery.~      The primary endpoint is~      - to investigate the safety of the SmartPill® in patients after abdominal surgery.~      The secondary endpoints are:~        -  is the SmartPill® able to detect the gastrointestinal transit and the peristaltic~          activity followed by abdominal surgery compared with patients which underwent~          thoracic/vascular surgery.~        -  is it possible to correlate the measured parameters (delayed gastrointestinal transit,~          lack of peristalsis) with the clinical signs of POI (nausea, vomiting, prolonged~          duration until first postoperative defecation).~        -  is the detected peristaltic activity influenced by intravenous applicated prokinetic~          drugs~        -  is the detected peristaltic activity influenced by physiotherapy~      Using those endpoints the investigators hope to demonstrate the safety of the SmartPill®~     after abdominal surgery, to evaluate its ability to analyse severity and length of POI and to~     examine whether the used prokinetic drugs and postoperative mobilization are able to~     influence peristaltic activity.~   "
94525|NCT02329899|"~     Observational study aimed at evaluating the clinical impact of a standardised diagnostic~     procedure for the investigation of patients with suspected mild bleeding disorder (MBD).~   "
94526|NCT02329886|"~     China, efforts are underway to respond to an unprecedented epidemiologic transition, with~     soaring rates of cardiovascular disease (CVD), including heart disease and stroke. Yet there~     may be limitations in translating observations and findings derived from Anglo-based~     population studies. As such, there is a critical need for population-based studies that~     provide insight into the risk factors, incidence, and outcomes of CVD in China. The Qingdao~     Port Health Study is a population-based prospective cohort study of employees of the Qingdao~     Port Group, China, designed to investigate the burden of CVD and risk factors (e.g.,~     sociodemographic, biological, environmental and clinical factors) associated with disease~     onset and outcomes.~   "
94527|NCT02329873|"~     The purpose of this randomized controlled trial was to evaluate the effects of a respiratory~     rehabilitation exercise training package on dyspnea, cough, exercise tolerance, and sputum~     expectoration of hospitalized elderly patients with acute exacerbation of chronic obstructive~     pulmonary disease (AECOPD). Using purposive sampling, 61 participants were recruited and~     randomly assigned to either the experimental group (n = 30) or the control group (n = 31).~     The experimental group participants received the respiratory rehabilitation exercise training~     twice a day and 10-30 minutes per session for four days. The control group participants~     received usual care and health education. Data were collected at baseline and at the end of~     the four-day intervention.~   "
94528|NCT02329860|"~     This was a multicenter, randomized, double-blind, phase III trial. This clinical study~     evaluates the efficacy and safety of Apatinib in patients with advanced liver cancer who have~     progressed on Systemic Therapy (Chemotherapy and/or Targeted Therapy).~      Approximately 400 patients who meet the entry criteria will be randomly assigned in a 2:1~     ratio to Apatinib or placebo (1/3 chance to receive placebo).~      Primary endpoint of the study is overall survival.~   "
94529|NCT02329847|"~     The purpose of this study is to determine the safety and to establish the recommended phase 2~     dose (RP2D) for the combination of ibrutinib and nivolumab in participants with chronic~     lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), follicular cell lymphoma (FL)~     and diffuse large B-cell lymphoma (DLBCL). Once the dose is optimized, the combination will~     be assessed for Pharmacokinetics, Pharmacodynamics, and preliminary efficacy, further safety~     in participants with CLL/SLL, FL or DLBCL and in participants with Richter syndrome.~   "
94548|NCT02329600|"~     The study included forty individuals divided into 3 groups. 10 control subjects, 15 oral~     lichen planus (OLP) patients who were treated with topical corticosteroids and 15 oral lichen~     planus (OLP) patients who were treated with topical corticosteroids and green tea tablets.~   "
94549|NCT02329587|"~     This study is investigating whether combining noninvasive brain stimulation with behavior~     therapy can help to improve outcomes for obsessive-compulsive disorder (OCD). Exposure and~     response prevention (ERP) -- a specific type of behavior therapy -- is a first line treatment~     for OCD. This study will test whether a form of noninvasive brain stimulation called~     transcranial direct current stimulation (tDCS), can help ERP work better.~   "
94530|NCT02329834|"~     The proposed study aims to compare the pharmacokinetics and bioavailability of intravenous~     and subcutaneous Furosemide. Although these regimens are not intended to be bioequivalent,~     they are both expected to achieve therapeutic plasma levels and induce effective diuresis.~      The test formulation in this study is a buffered solution, Furosemide Injection Solution at 8~     mg/mL at pH 7.4 (range 7.0 to 7.8) and is intended for SC injection according to the~     instructions in the protocol. A commercial formulation of Furosemide Injection, USP will~     serve as the reference drug in this study, which will be administered by IV bolus. It~     contains furosemide 10 mg/mL in solution at alkaline pH of 8.0 to 9.3 and is marketed for IV~     and IM injection.~      The objectives of this study are:~        -  To characterize the pharmacokinetics of furosemide administered by continuous~          subcutaneous infusion using a biphasic delivery profile.~        -  To estimate the absolute bioavailability of furosemide administered by continuous~          subcutaneous infusion compared with an equivalent dose of furosemide administered by~          intravenous bolus administration.~   "
94531|NCT02329821|"~     The investigators are trying to investigate metabolism of lactate sourced from IV Hartmann's~     solution in patients with hepatocellular carcinoma(HCC) compared with a control~     group(donation for liver transplantation) with normal liver function. Second purpose of this~     study is finding the predictive factor of changing metabolism of lactate sourced from IV~     Hartmann's solution in patients with HCC.~   "
94532|NCT02329808|"~     This is a clincial validation study of a dried blood spot (DBS) method for the analysis of~     immunosuppressive and antifungal agents currently subject of therapeutic drug monitoring~     (TDM) in a pediatric population.~      The primary goal is to clinically validate a finger prick DBS method compared to conventional~     venous sampling for the analysis of 5 immunosuppressive and 4 azole antifungal drugs in the~     pediatric population. Secondairy goals include feasibility of the finger prick DBS method in~     the target population, to design an inventory of costs that will be incurred in future~     health-economic analyses and to construct a population PK model based on the available data~     collected for the primariy goal.~   "
94533|NCT02329795|"~     This study seeks to investigate if advanced image-analysis of diagnostic scans, can be used~     to predict how aggressive brain tumors (glioblastoma) respond to standard chemo- and~     radiation treatment.~   "
94534|NCT02329782|"~     Multi-site, randomized controlled trial of the Adherence Readiness Program (ARP) adherence~     intervention for HIV clients starting or restarting antiretroviral therapy (ART) for the~     purpose of achieving and sustaining optimal levels of ART adherence and virologic~     suppression. Eligible participants will be randomized to receive either the ARP intervention~     or usual care (no intervention) and followed for 24 months.~   "
94535|NCT02329769|"~     The purpose of this study is to see whether PRO044 is safe and effective to use as medication~     for Duchenne Muscular Dystrophy (DMD) patients with a mutation around location 44 in the DNA~     for the dystrophin protein.~   "
94536|NCT02329756|"~     The objective of this study is to investigate the effect of tranexamic acid (TXA)~     administration on the outcome of cesarean-hysterectomy in women with suspected Morbidly~     Adherent Placenta (MAP; placenta accreta, increta, percreta).~   "
94537|NCT02329743|"~     The primary objective of this study is to assess the efficacy and safety of 2 concentrations~     of RX-10045 ophthalmic solution, 0.05% and 0.1%, compared to placebo for the treatment of~     ocular inflammation and pain in subjects undergoing cataract surgery.~   "
94538|NCT02329730|"~     Choose healthy subjects and patients with TB, distribute them into different dose groups~     according to the recombinant EC allergen dose from low to high average. Conducting clinical~     trials of TB-PPD or placebo as controlled arms intradermal injection. Do specific interferon~     gamma detection before the skin test，after the test 72h±2h and 144h±2h. Evaluate the safety~     of the recombinant EC allergy , and provide the appropriate dose range for phase IIb clinical~     trials.~   "
94539|NCT02329717|"~     This study evaluates the efficacy and safety of PBI-05204, an extract of the leaves of Nerium~     oleander, in patients with Stage IV metastatic pancreatic cancer. All patients will receive~     PBI-05204.~   "
94540|NCT02329704|"~     This study evaluates the quality of sperm produced after semen processing using Density~     Gradient (DG) and swimming down (SD).~   "
94541|NCT02329691|"~     The main objective is to explore and evaluate the effect of a change in the WHO checklist on~     the safety climate in the operating room at a University Hospital in Gothenburg.~   "
94542|NCT02329678|"~     Introduction: The present clinical trial was conducted to evaluate the efficacy of membrane~     barrier in the healing of apicomarginal defects.~      Methods: Thirty patients meeting inclusion criteria were selected and allocated randomly into~     two groups: collagen membrane group and control group. Clinical and radiographic measurements~     were recorded during follow up at regular intervals of 0, 3, 6, 9, and 12 months after~     surgery. The criteria for success included the absence of clinical signs and symptoms, and~     complete or incomplete radiographic healing.~   "
94543|NCT02329665|"~     The primary objective of this study is to collect CT images of patients undergoing CT Guided~     Needle Intervention Procedures which will be used for the development of the NeedleWaysTM~     System.~   "
94544|NCT02329652|"~     This study is to evaluate the use of a fully implanted device for providing hand function,~     reach, and trunk function to individuals with cervical spinal cord injury.~      Funding Sources:~      FDA OOPD NIH NINDS~   "
94545|NCT02329639|"~     Metastatic Breast cancer (MBC) patients from ten Italian Divisions of Medical Oncology, with~     histologically confirmed HER2-negative MBC, treated with a first-line therapy including~     bevacizumab 10 mg/m2 i.v. on days 1 and 15 combined with first-line paclitaxel 90 mg/m2 i.v.~     on days 1,8 and 15, every 4 weeks, will be enrolled for the present pharmacogenetic study.~     MBC patients treated with first-line chemotherapy including paclitaxel without bevacizumab~     will be also enrolled as control group.~   "
94546|NCT02329626|"~     The main objective of this study is to make a first evaluation of the relationship between~     metabolic abnormalities objectified by Positron emission tomography with~     2-deoxy-2-[fluorine-18]fluoro- D-glucose integrated with computed tomography (PET CT 18 FDH)~     performed at rest at the onset of symptoms in patients with a first episode of motor~     conversion disorder and the persistence of a motor disability at 6 months measured by the~     modified Rankin score (mRS).~   "
94550|NCT02329574|"~     Chronic pain is devastating both to individuals and society. In an aging population, surgery~     is an increasing cause of chronic pain, with rates of persistent post-operative pain ranging~     from 10-65%.In particular, Persistent Post-Mastectomy Pain (PPMP) occurs in roughly one third~     of women who have had mastectomy. The occurrence of PPMP does not seem to be strongly~     determined by the type of surgery, chemotherapy, and radiation treatment, suggesting that~     individual person-specific factors may play a more important role. In fact, recent studies~     indicate that individual differences in pain sensitivity (psychophysics) are more closely~     associated with PPMP than surgical/medical variables. Specifically, sensory testing revealed~     that women who developed PPMP had lower pressure pain thresholds and greater temporal~     summation of pain stimuli than women who did not develop this chronic pain condition.~     Moreover, psychosocial factors such as anxiety, depression, catastrophizing, and somatization~     were more prominent in women with PPMP. These preliminary, retrospective studies suggest that~     individual psychophysical and psychosocial characteristics could be important risk factors~     for PPMP. Accordingly, the aim of this study is to comprehensively and prospectively study~     women having mastectomy surgery, to determine the relationship between pre-operative~     psychophysical and psychosocial factors and the development of PPMP. Using these data, a~     prediction model for PPMP will be developed, thus allowing a preoperative calculation of a~     PPMP risk score for any patient facing mastectomy.~   "
94551|NCT02329561|"~     This study evaluates the pharmacokinetics and pharmacodynamics of the enantiomers of tramadol~     and O-desmethyltramadol (ODM) in generally healthy young and elderly adults. Using a~     randomised, double-blind, crossover design, participants were administered a single 200mg~     tramadol extended-release tablet and placebo.~   "
94552|NCT02329548|"~     This study uses an Alizarin Red powder mixture to characterize the sweat distributions in~     youth during tilt table testing. Patients with a known orthostatic sweat response from a~     prior clinical tilt table test in the investigators laboratory will be recruited. The~     Alizarin Red powder will be applied to exposed skin, and quantitative sweat will be measured~     at the thigh. During tilt testing, serial photos will be taken once the sweat response~     occurs. Sweat distributions will be compared during syncope (orthostatic sweat), during~     periods of anxiety (emotional sweat), and in patients with POTS (with and without syncope).~   "
94553|NCT02329535|"~     Twin pregnancies are more likely to be delivered preterm than singleton pregnancies. Vaginal~     progesterone administration (200 mg Utrogestan) to asymptomatic women with a singleton~     pregnancy and sonographic short cervix reduced the risk of preterm birth (PTB) and neonatal~     morbidity and mortality, yet not proved efficient in twins' pregnancy. The investigators'~     hypothesis is that a higher dose of vaginal micronized progesterone will be more effective in~     preventing PTD. The objectives of the study is to compare the rate of preterm birth and~     perinatal morbidity and mortality in a twin pregnancy with short cervical length treated with~     vaginal 400 mg of micronized progesterone to no treatment. The study is Randomized, open~     label, of twin pregnancy between 16-26 weeks of gestation with cervical length under 25 mm.~     Women will be randomly assigned to either treatment or no treatment group. Progesterone~     treatment will be given until 36 weeks of gestation. Other management will be according to~     standard protocol.~   "
94554|NCT02329522|"~     Objective~      The Ultrasonic Cardiac Output Monitor (USCOM) is a non-invasive, quantitative method for~     measuring and monitoring cardiovascular haemodynamic parameters in patients. The aims of this~     study are:~        1. To investigate whether there is any correlation between haemodynamic parameters and COPD~          severity.~        2. To investigate whether USCOM-derived haemodynamic variables may be used as prognostic~          indicators of 6-month, 1-year, 3-year and 5-year readmission.~        3. To investigate whether USCOM-derived haemodynamic variables may be used as prognostic~          indicators of 6-month, 1-year, 3-year and 5-year all-cause mortality.~      Design, Setting and Subjects This prospective observational study will be conducted in the~     Prince of Wales Hospital in Hong Kong.~      Interventions Haemodynamic measurements made using the USCOM, and spirometry, will be~     performed as appropriate on subjects in respiratory clinic, the emergency department, medical~     wards and on ICU. In order to assess inter-observer variability, a second, blinded operator~     will repeated 15% of scans.~   "
94555|NCT02329509|"~     The purpose of this study is to evaluate which surgical protocol for treating Unilateral~     Cleft Lip and Palate (UCLP), a single or two stage repair ( with hard palate late closure)~     will have less impact in mid facial growth.~      The study hypothesis states that a two stage cleft palate repair , with a late hard palate~     repair will reduce maxillary growth impairment.~   "
94556|NCT02329496|"~     To confirm the acute performance and safety of the Lotus™ Valve with the Next Generation~     Delivery System for transcatheter aortic valve replacement (TAVR) in symptomatic patients~     with severe calcific aortic stenosis who are considered high risk for surgical valve~     replacement.~   "
94557|NCT02329483|"~     This study aims to predefine the threshold FSH doses during the early follicular phases in~     low- dose step-up ovulation induction cycles used to treat anticipated high responders by~     monitoring total testosterone and androstenedione blood levels. The blood levels of total~     testosterone and androstenedione levels will be measured in patients at the starting day and~     at every control day when vaginal sonographic folliculometries and blood estradiol~     measurements are made. Hence, we are aiming to define an early monitoring parameter by which~     we will be able to define a follicular response to treatment before estradiol rise or~     apparently selected follicular growth.~   "
94558|NCT02329470|"~     A randomized, controlled study in parallel design recruiting 100 patients, 50 in each group.~     The patients have had CPAP (Continuous Positive Airway Pressure) treatment between 2 months~     to 2 years. The patients are investigated, then half of them (50 patients) are randomized to~     withdrawal of CPAP treatment during 3-5 nights followed by second investigation. 50 patients~     (control group) continue with CPAP but are investigated similarly than CPAP withdrawal group~     after 3-5 nights. The aim of the study is to investigate the effects of obstructive sleep~     apnea to arterial stiffness (primary outcome) and whether there is increase in insulin~     resistance, cathecol amines, if systemic inflammation occurs after short-term CPAP~     withdrawal, and what is the impact of age, gender and oxygen saturation on arterial stiffness~     (secondary outcomes).~   "
96221|NCT02307695|"~     To investigate whether saxagliptin could reduce the fluctuation of glycemia and improve the~     glycemic control in those type 1 diabetes through mechanisms of suppressing glucagon~     secretion, improving beta cell function, and re-regulating of the T cell immune system.~   "
94559|NCT02329457|"~     Hematopoietic stem cell transplantation (HSCT) is well-established therapy for patients with~     malignant hematological diseases. Varicella zoster virus (VZV) reactivation, clinically~     manifested as herpes zoster (HZ), is a major complication that affects up to 50% of patients.~     Most patients will require hospitalization. Despite treatment with high dose acyclovir,~     patients may develop severe complications including the disabling postherpetic neuralgia,~     corneal ulceration, viral dissemination and secondary bacterial infection. The median onset~     of infection is the fifth month following transplantation, with 91% of cases occurring within~     the first year. Direct vaccination of transplants recipients with subcutaneous~     live-attenuated VZVv before transplantation and up to one year after transplantation is~     contraindicated. A small prospective non-randomized study has demonstrated that subcutaneous~     vaccination for donors before HSCT may offer some protection against VZV reactivation in the~     recipients. Recently, dose-sparing influenza vaccine delivered via a novel intradermal~     microneedle has been shown to elicit a good immunogenic response in both healthy and elderly~     subjects. We sought to assess the efficacy and safety of the novel intradermal~     live-attenuated VZVv in sibling donors undergoing HSCT.~   "
94560|NCT02329444|"~     Contrast-induced acute kidney injury (CI-AKI) is a significant iatrogenic complication of~     contrast media use associated with prolonged hospitalization, cardiovascular events,~     persistent kidney damage and increased risk of all-cause mortality. When remote ischemic~     preconditioning is applied before percutaneous coronary intervention (PCI), the kidneys can~     be protected against ischemia-reperfusion injury and subsequently CI-AKI. In this randomised~     controlled trial, diabetic nephropathy patients undergoing PCI as part of their assessment~     and treatment of cardiovascular disease are randomized to receive RIPC or control sham~     preconditioning.~   "
94561|NCT02329431|"~     The goal of this study is to develop an intervention to teach activation skills to Latino~     parents who bring children for mental health services.~   "
94562|NCT02329418|"~     Relatives of patients in situation of withholding and withdrawing life-sustaining therapies~     often show post traumatic stress disorder (PTSD) (60%)[1]. This number is even greater when~     family members are active in this decision (81%) or when communication is not optimal between~     medical team and family members.~      There are several ways to assist families of patients in intensive care units [2], amongst~     them the use of a written document to explain the environment, therapies and possible~     outcomes.~      Here the investigators want to test the impact of a written document in the context of~     end-of-life conference in intensive care units. Specifically, this research addresses wether~     such written support could decrease 3-months post-traumatic stress disorder, anxiety and~     depression exhibited by the closest family member or the patient representative.~   "
94563|NCT02329405|"~     This study investigates the effects of pregnane X receptor (PXR) activation on hepatic fat~     content in healthy volunteers. Rifampicin (an antibiotic and also an efficient PXR activator)~     and placebo will be given for a week to volunteers. Hepatic fat content is measured with~     magnetic resonance imaging and blood samples are collected at the end of each study arm. The~     investigators' hypothesis is that rifampicin causes accumulation of fat to the liver.~   "
94564|NCT02329392|"~     This study is aim to evaluate usefulness of the perioperative monitoring of skin perfusion~     pressure as an indicator of perpheral perfusion in patients undergoing on-pump cardiac~     surgery. Association of the intraoperative and postoperative 6hr skin perfusion pressure with~     perioperative serum lactate level is going to be assessed.~   "
94565|NCT02329379|"~     1. To elucidate the therapeutic role of levothyroxine on the patient with atypia of~          undetermined significance (AUS) goiter, we would design a prospective, open label and~          non-randomized trial to verify the therapeutic effects on goiter with AUS by means of~          TSH (Thyrotropin; Thyroid-Stimulating Hormone) suppression related reduction of goiter~          volume with subsequent alleviation of previous cytological malignant tendency. During~          following for 1-2 years after therapy with simultaneous monitor of possible adverse~          effects of levothyroxine (eltroxin), we collected blood samples and gathered all~          necessary data as well as performed thyroid sonography with fine-needle aspiration (FNA)~          for the subjects. Furthermore, we would finish our individual study for each enrolled~          subject if his/her condition exhibited the criteria of primary end point: reduced goiter~          volume under sono >15% or cytology: benign for 2 times; operation for thyroidectomy, CAD~          attack, refractory arrhythmia, newly DM (Diabetes Mellitus), etc.~        2. To re-evaluate the current prevalence of goiter within Taiwanese adults, we recruited~          all patients who presented possible thyroid related symptoms, such as unexplained body~          weight loss with increased appetite, palpitation, hand tremors, neck swelling,~          hoarseness and abnormal sensation over throat. Only the patients with goiter proven by~          thyroid sono in euthyroid status without other preexisting major disorders can be~          enrolled in our trial to undergo open label, non-randomized study.~   "
94566|NCT02329366|"~     This project aims to result in the identification of such markers, and the development of a~     feasible quantitative method of distinguishing between tissue that has the capacity to heal~     and tissue that does not, thus identifying a non-healing phenotype.~   "
94567|NCT02329353|"~     Periodontitis is one of the most common chronic inflammatory disease with the etiology of~     bacterial plaque and is associated with a number of putative bacterial species. The~     periodontal destruction is substantially mediated by the host, driven by the bacterial~     challenge. The presence of pathogenic bacteria with the absence of so-called beneficial~     bacteria and the susceptibility of the host are the main aetiological factors of periodontal~     diseases.~   "
94568|NCT02329340|"~     Injuries are the leading cause of death and disability in children in America. Most injuries~     can be prevented when parents implement effective child safety practices. This project will~     create a behaviorally based program to teach parents what to do to prevent injuries to their~     school aged child, in an effort to reduce the number of injuries, hospitalizations, medical~     costs, and missed work days.~   "
94569|NCT02329327|"~     The purpose of this study is to evaluate the hemostatic efficacy of andexanet alfa in~     patients receiving a factor Xa inhibitor who are experiencing an acute major bleed. The~     safety of andexanet will also be studied.~   "
94570|NCT02329314|"~     Collect the details about hepatic dysfunctional patients induced by various etiology who have~     a usage of Glycyrrhizic Acid, then arrange and analyse the data to evaluate the clinical~     curative effect of glycyrrhizic acid.~   "
94572|NCT02329288|"~     NAION produces an ischemic insult in the optic nerve head presumably due to the hypoperfusion~     of the short ciliary arteries that supply it.~      Intravenous injection of glucocorticoid have proven to be effective in treatment of~     Nonarteritic Anterior Ischemic Optic Neuropathy,but have some side effects. the investigators~     believe that offering them Retrobulbar Triamcinolone Acetonide Injection that might halt the~     progression of the visual acuity and visual field loss if our hypothesis is correct, would~     greatly improve their chances of avoiding blindness.~   "
94573|NCT02329275|"~     Azoospermia is found in 5-20% of all men suffering from infertility, and in more than 20%~     azoospermia remains unexplained. The investigators suggest, that HPV may be an etiological~     factor in azoospermia and reduced sperm production.~      The investigators plan to examine the occurrence of HPV in testicular tissue from 100~     azoospermic men and to compare with the HPV occurrence in testicular tissue from a control~     group of 40 normal, healthy men undergoing vasectomy. Since HPV, in a recent Danish study,~     was detected on sperm in 16% of 188 randomly selected semen donors, the investigators also~     plan to examine the occurrence of HPV on sperm ejaculated during the last week before~     vasectomy. If HPV should be found in testicular tissue from men belonging to the control~     group, it will be highly relevant to compare with the HPV occurrence on sperm ejaculated from~     the men in concern.~      A Linear Array HPV Genotyping Kit from Roche will be used for detection of HPV in testicular~     tissue and ejaculates. In total, with this test kit 37 HPV genotypes are examined for,~     including 13 high risk types.~   "
94574|NCT02329262|"~     This approach will train peer mentors to deliver a culturally appropriate intervention and~     provide social support that is critical for facilitating and sustaining health behavior~     change. The objective is to compare the efficacy of an innovative healthy lifestyle skills~     mentoring program (Mentored Planning to be Active [MBA]) to a teacher led program (PBA) for~     increasing physical activity in Appalachian high school teens. MBA emphasizes the social~     determinants of health by using a social networking approach that trains peer mentors to~     support targeted teens~   "
94575|NCT02329249|"~     There is an important need for effective smoking cessation programs that both (a) promote the~     effective use of pharmacological aids, such as nicotine replacement products and bupropion,~     and (b) provide cognitive-behavioral support for stopping smoking.The Internet is an~     increasingly attractive intervention medium for delivering behavior change interventions,~     including smoking cessation.This study examined smoking cessation rates among adults~     participating in a randomized controlled trial of the Smokefree Partners: 21 Days to Freedom~     ™ program, a theoretically based, online smoking cessation program that included message~     tailoring and interactivity combined with the live personal support of a smoking cessation~     coach. Coaching support was provided almost entirely asynchronously via prescripted but~     individually tailored emails.~   "
94576|NCT02329236|"~     The aim of the our study is to investigate whether there is an increased incidence of ADHD (~     based on self reports and questionnaires) among children with short stature due to~     constitutional growth delay (CGD) in comparison with children with Familial short stature.~   "
94577|NCT02329223|"~     This was a Phase III, multicenter, randomized, double-blind, placebo-controlled,~     parallel-group study to evaluate the efficacy and safety of omalizumab administered~     subcutaneously as an add-on therapy for the treatment of adolescent and adult participants 12~     - 75 years who received the diagnosis of refractory chronic spontaneous uriticaria and who~     remained symptomatic despite standard-dosed non-sedating H1 antihistamine treatment.~   "
94578|NCT02329210|"~     Bardet-Biedl Syndrome (BBS) is a rare genetic disorder associated with a vast array of~     symptoms. The features of BBS are highly variable, even between siblings, making long-term~     follow-up and centralization of information vital to better understanding this complex~     disease and designing effective treatments.~      Marshfield Clinic has developed the Clinical Registry Investigating Bardet-Biedl Syndrome~     (CRIBBS) to gather comprehensive health information from patients diagnosed with BBS in a~     single repository. This information will be used to inform patients, families, and physicians~     about the complex features of BBS and will serve as a platform for researchers to develop~     effective and targeted treatment strategies for patients with BBS.~      CRIBBS is a web-based, confidential database and the privacy of patients enrolled in the~     registry will always be respected. Information maintained in the database will be~     identifiable only by an assigned study identification number, not by name. The registry~     strictly complies with HIPAA regulations. CRIBBS participants may be contacted periodically~     with information regarding clinical trials or research studies, but participation is entirely~     voluntary.~      CRIBBS will bring together complex genetic and clinical information from BBS patients to~     accelerate research into effective treatments, attract additional researchers, and make it~     easier for researchers to identify patients and find funding for innovative studies.~   "
94579|NCT02329197|"~     Women with history of previous IVF cycle failure will be subjected to a fresh IVF cycle. At~     the time they will be undergoing embryo transfer, 50 IU of human chorionic gonadotropins~     diluted in 0.025ml of tissue culture media will be injected intrauterine by embryo transfer~     catheter 10 minutes before embryo transfer procedure.~   "
94580|NCT02329184|"~     The purpose of this study is to establish initial safety, tolerability, pharmacokinetics and~     pharmacodynamics of MYK-461 in human subjects. This is a sequential group, single ascending~     (oral) dose study in NYHA Class I, II, or III patient volunteers aged 18-65 years.~   "
94601|NCT02328911|"~     The proposed study is a randomized, double-blinded clinical trial to evaluate the efficacy of~     a course of laser therapy on peripheral neuropathic pain in persons with diabetes. The~     hypothesis is that laser therapy will produce significant improvement on measures of~     self-reported pain among adults with diabetes.~   "
94602|NCT02328898|"~     The study objective is to assess the safety and efficacy of the Permanent Polymer~     Zotarolimus-Eluting Stent Resolute Integrity™ to the Polymer Free Amphilimus-Eluting Stent~     Cre8™ compared in an all-comer patient population. 1 month of dual antiplatelet duration will~     be applied in stable angina pectoris patients. Myocardial infarction patient population will~     be treated with 12 months of dual antiplatelet therapy.~   "
94603|NCT02328885|"~     Pilot, multicentric, open-label, single-arm, phase I-II clinical trial to evaluate the safety~     and efficacy of a novel Umbilical Cord Blood Transplantation (UCBT) platform, that consists~     of a UCBT of the 80 fraction, followed by a Donor Lymphocyte Infusion (DLI) of the 20~     fraction (between 60 and 90 days after transplantation).~   "
94581|NCT02329171|"~     Rationale:~      Cervical Intraepithelial Neoplasia (CIN) is the premalignant condition of cervical cancer.~     High grade CIN (CIN 2-3) is currently treated by large loop excision of the transformation~     zone (LLETZ). This treatment has potential complications, such as hemorrhage, infection and~     preterm birth in subsequent pregnancies. For this reason, non-invasive therapies are needed.~     Imiquimod (an immunomodulator) was proven effective in the treatment of HPV-related vulvar~     intraepithelial neoplasia (VIN) and may also be effective in HPV-related CIN. [van Seters,~     2012] However, the evidence is limited and study results are not consistent. [Grimm, 2012;~     Pachman, 2012; Lin, 2012]~      Objectives:~      Primary objectives: (1) to investigate the efficacy of imiquimod 5% cream for the treatment~     of CIN2-3 lesions and (2) to develop biomarker panels to predict clinical response to~     imiquimod therapy.~      Secondary objectives: to assess side effects of imiquimod treatment and LLETZ, disease~     recurrence and quality of life.~      Hypothesis:~      The investigators hypothesize that imiquimod will be an effective treatment modality in~     approximately 50-75% of CIN lesions treated without surgical intervention.~      Study design:~      Single-centre randomized controlled intervention trial.~      Study population:~      140 women with a histological diagnosis of CIN2-3, equally divided over two study arms.~      Intervention:~      Patients will be randomized into one of two arms:~        1. Imiquimod treatment arm. Patients in this group are treated by a 16-week regime of~          imiquimod 5% cream.~        2. Standard treatment arm. LLETZ will be performed on patients in this group.~      Colposcopy with diagnostic biopsies will be performed after 10 weeks for the imiquimod~     treatment arm. In case progressive disease, the treatment will be ended and appropriate~     surgical excision will be performed. Treatment efficacy will be evaluated after 20 weeks, by~     colposcopy with diagnostic biopsies. A histological biomarker panel will be developed,~     consisting of markers representing both host and viral factors.~      Main study parameters/endpoints:~      The primary endpoint of the study is regression-or-not of CIN2-3, defined as CIN1 or less at~     the colposcopy at 20 weeks for the imiquimod arm and PAP 1 cytology at 6 months for the LLETZ~     group.~   "
94582|NCT02329158|"~     The purpose of this study is to determine whether disinvestment in hydroxyl-ethyl starches~     (HES) for patients undergoing cardiac surgery was safe and effective.~   "
94583|NCT02329145|"~     Chronic heart failure is becoming more and more common disease and activation of sympathetic~     nervous system plays a crucial role in its development. There is some data allowing to~     suspect that one of the new treatment methods- renal denervation, also in patients with~     chronic heart failure may lead to decrease of systemic activity sympathetic nervous system~     and, as a consequence, to decrease of disease progression. The research hypothesis is whether~     renal denervation in case of symptomatic heart failure, even the optimal treatment therapy is~     used (including resynchronization therapy), is contributing to the improvement in parameters~     of neurohormonal activation, hemodynamics and clinical patient status. The aim of the study~     is to obtain a new knowledge concerning renal denervation in chronic heart failure, So far~     only very limited data- mostly case reports- are available in this study area.~   "
94584|NCT02329132|"~     Recent reports suggest that anti-VEGF agents (ranibizumab) may suppress the progression of~     retinal nonperfusion area. This protective effect would cause the increase of the oxygen~     consumption in the diabetic retina. We expect that the current study using the retinal~     oximetry would show the protective effects of ranibizumab on the hypoxia in the diabetic~     retina. This study is designed to analyze the effects of ranibizumab (Lucentis) to the~     retinal oxygen saturation or consumption in eyes with diabetic macular edema.~   "
94585|NCT02329119|"~     Schizophrenia is considered as the most frequent and the most severe chronic psychotic~     disorder. Its evolutionary modes and its clinical symptomatology remain particularly~     heterogeneous. Moreover, the brain processes involved in schizophrenia are still far from~     being clearly understood. Current empirical studies provide a mean duration comprised between~     1 and 3 years without any specific diagnosis or treatment. These diagnosis issues are partly~     based on difficulties in the early distinction between schizophrenia and bipolar affective~     disorders (BD).~      These results emphasize the necessity of new early indices (or endophenotypes). Such markers~     are intended to be more specific than classical clinical manifestations. In other words, they~     have to be absent among patients with differential diagnosis, such as BD. Among other~     possible early indices, several electrophysiological disturbances have been explored.~      Our study is designed to mainly describe the N400 component among patients with schizophrenia~     or BD. This component is classically interpreted as indexing the integration the meaning of a~     linguistic stimulus in its preceding context. Our main hypothesis aims to show a specific~     alteration of N400 component among patients with schizophrenia when compared to participants~     with BD.~      The second aim of this study concerns the exploration of four other event related potentials~     (ERPs) among patients with schizophrenia or BD:~        -  the P50 component, involved in early sensory gating processes,~        -  the P300 component, thought to reflect attentional resource allocation and working~          memory updating of stimulus context,~        -  the P600 component, elicited during same paradigms than N400, and reflecting their~          syntactic congruity.~        -  the CNV (Contingent Negative Variation), reflecting processes of motor anticipation~      Regarding to their potential 'endophenotypes' status, our aim consists in comparing the N400~     and three other ERPs among patients with schizophrenia or bipolar affective disorder. Since~     the schizophrenic specificity of such ERPs alterations still remains rarely studied, we also~     propose to describe the possible relations between these ERPs results and clinical scores~     observed among patients.~   "
94586|NCT02329106|"~     The purpose of this study is to evaluate the safety and efficacy of irreversible~     electroportion in unresectable liver cancer close to diaphragmatic dome.~   "
94587|NCT02329093|"~     As we have previously reported, the primary cause of hip OA with accompanying joint pain~     might be bone alterations which can be microfracture. In order to prove it, it is planned~     that conservative treatment will be performed on the hip OA patients with accompanying joint~     pain for the first year. For the second year, if the patients still have joint pain, they~     will do non-weght bearing walk.~   "
94588|NCT02329080|"~     This is an open, non comparative, multicentre phase II trial, to evaluate the efficacy and~     feasibility of a new sequential combination of HD-MTX-AraC-based chemoimmunotherapy, followed~     by R-ICE regimen, and by high-dose chemotherapy supported by ASCT.~   "
94589|NCT02329067|"~     The objectives of the proposed study are to assess whether the metabolic effects of walnut~     consumption depends on which food components the walnuts substitute (i.e. carbohydrates;~     saturated fatty acids) and whether it is important to consume walnuts as snacks or with~     meals.~   "
94590|NCT02329054|"~     There is no specific treatment for Ebola Virus Disease (EVD). Current EVD care are~     supportive, and includes intravenous or oral rehydration, nutrition, pain killers, treatment~     of coinfections with antibacterial and antimalarial drugs, and blood transfusion when~     appropriate. Despite these interventions, mortality remains high since the ongoing Ebola~     outbreak in West Africa was declared in April.~      Potential anti-Ebola specific interventions include convalescent plasma, monoclonal and~     polyclonal antibodies, small inhibitory RNA (siRNA), synthetic adenosine analogues or RNA~     polymerase inhibitors. All these interventions are considered investigational due to lack of~     data in humans with EVD.~      In this study, the investigators chose to study the efficacy of favipiravir because this~     drug:~        -  showed anti-Ebola efficacy in immunodeficient murine models;~        -  has been studied in thousands of adult humans participating in anti-influenza trials,~          with good tolerance; it has been approved for treating novel or resistant influenza~          infections in Japan;~        -  is immediately available;~        -  can be used orally, and can be easily given in both adults and children because pills~          can be crushed and mixed in food or liquids;~        -  has recently been used in Europe for treating several patients with EVD; the French drug~          safety agency (ANSM) has reviewed published data as well as data provided by the firm~          (Toyama Chemical Co., Ltd), and approved its compassionate use in EVD.~      Here the investigators propose to assess the efficacy of high-dosed favipiravir in reducing~     mortality in humans with EVD.~      In the present trial JIKI (means Hope in Kissi language), investigators, sponsor,~     scientific advisory board and safety monitoring board will be coordinated in a very reactive~     way, so that any new fact can be discussed rapidly and the research plan can be adapted~     accordingly (change in drug dosage; use of drug combination; combination with another~     strategy such as passive immunization with convalescent plasma, etc.).~   "
94592|NCT02329028|"~     The EEG is widely used in the diagnosis of central nervous system pathology, including~     epileptic seizures and epilepsy. Presently, EEG is available only during office hours in most~     hospitals, pending on the availability of a clinical neurophysiologist and the lack of oncall~     possibility outside these hours. Standard EEG devices are large and their operation require~     meticulous application of several leads. The department of clinical neurophysiology at~     Helsinki University Central Hospital has developed a mini-EEG device for use in the emergency~     department as well as in the prehospital setting. The aims of this pilot study is to evaluate~     the feasibility of the mini-EEG in the prehospital setting. Patients with a decreased level~     of consciousness, as evaluated by the emergency medical provider on the scene, are included.~     The mini--EEG device is to be used by a specially trained emergency medical supervisor. EEG~     is otherwise obtained in a normal fashion, but only three electrodes are used. The sample~     size is 30. Data are collected as a part of the clinical work in daily practice. The aim is~     to collect observational data on feasibility, no clinical interventions will be performed~     based on the EEG. No funding is needed as data is collected during daily work.~      The mini-EEG is a prototype EEG/EKG-adapter, designed by Helsinki Univeristy Central~     Hospital, and as such, does not have a trade name. It is to be connected to a~     monitor/defibrillator used by the EMS personel, currently the LifePak 15, manufactured by~     Physio-Control, Redmond, WA 98052. (www.physio-control.com)~   "
94593|NCT02329015|"~     The purpose of this study is to compare the academic and psycho-social benefits of a~     yoga-informed health and wellness program (HWP) to a standard physical education program for~     middle and high school students within New York City (NYC) schools.~   "
94594|NCT02329002|"~     Rationale: Hereditary retinoblastoma survivors have an increased risk to develop second~     primary tumors (SPT) at a later age (with the highest risk in their teens), especially when~     they have been irradiated for retinoblastoma. The investigators hypothesize that regular~     screening with magnetic resonance imaging (MRI) could lead to early detection of SPTs leading~     to improved survival.~      Objective: To evaluate the potential benefit of craniofacial MRI screening for early~     detection subclinical secondary cancers in patients previously irradiated for hereditary~     retinoblastoma.~      Study design: Prospective multicenter non-invasive screening study. The total study duration~     will be four years of screening plus five years of follow-up.~      Study population: Irradiated hereditary retinoblastoma patients 8-18 years old Main study~     parameters/endpoints: To evaluate the ability of craniofacial MRI for early detection of~     SPTs, the investigators will determine the sensitivity and specificity of MRI at detecting~     SPTs in irradiated hereditary retinoblastoma patients.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: Included patients will undergo yearly craniofacial MRI for a period of 4 years.~     They will also be asked to fill out a psychological burden assessment form each visit. A~     potential risk of screening might be associated anticipatory anxiety, but screening also~     could be reassuring for patients and their parents; the investigators are not sure which will~     outweigh. False-positive results from MRI screening could lead to unnecessary further~     diagnostics leading to possible added anxiety and diagnostics (e.g., biopsies). However, this~     group of patients have a high risk of developing SPTs, with poor 5-year survival statistics.~     Early detection and therefore treatment of earlier stage (smaller) tumors, might therefore~     increase survival of this patient group.~   "
94595|NCT02328989|"~     For 25 years, the twin pregnancy rate has regularly increased in the majority of European~     countries and in the United States, by 35% between 1981 and 2006. Increased use of medically~     assisted procreation and older maternal age are the two main causes. At the present time twin~     pregnancies represent nearly 20% of premature deliveries. The rate of very premature births~     (< 32-34 weeks) is 7 times higher in twin pregnancies than in singleton pregnancies. As~     prematurity accounts for 75% of neonatal morbidity and mortality, and extreme prematurity is~     the principal cause of neonatal mortality and of brain sequelae in twins, the search for a~     preventive treatment appears as a priority in perinatal medicine. The investigators recently~     showed in a prospective multicenter study that cervical ultrasound at 22 and 27 wks was a~     better predictive investigation of premature delivery < 34 wks than digital examination.~     Recently in a randomized trial in a population of short-cervix singleton pregnancies, the~     premature delivery rate decreased by 40% in the pessary group compared with the usual~     management group. No other trial of pessary use in short-cervix twin pregnancies was~     published today. Recently, in a historical comparison of twins with twin-to-twin transfusion~     syndrome treated with laser, Carreras et al. have showed a decreased rate of preterm delivery~     with the use of pessary in case of short cervix. The investigators wish to set up a~     randomized multicenter study in France in the population of short-cervix twin pregnancies to~     show a potential benefit of the pessary compared with simple surveillance.~   "
94596|NCT02328976|"~     The purpose is to compare, using functional magnetic resonance imagery in resting-state, the~     connectivity of the hypothalamus in 2 groups of migraineurs. The first group is composed of~     chronic migraineurs, studied outside a migraine attack and is compared to gender- and age-~     matched episodic migraineurs with very few attacks per month and studied in the attack-free~     period. The primary outcome will be the connectivity index of the hypothalamus to brainstem~     areas activated during migraine attacks and to the trigeminal-cervical complex.~   "
94597|NCT02328963|"~     Cytomegalovirus (CMV) infection is the most frequent opportunistic viral infection after~     transplantation. It is associated with an increased incidence of acute rejection and lower~     graft and patient survivals. The goal of this study is to demonstrate that an~     immunosuppressive regimen associating everolimus and reduced dose of cyclosporine A can~     prevent acute rejection episodes as efficiently as standard regimen but also efficiently~     reduce the incidence of CMV infection at 6 months post-transplantation.~   "
94598|NCT02328950|"~     A 5 day course of fludarabine and cytarabine (FA) will be administered followed by full~     intensity conditioning regimen (Bucy) in the setting of allogeneic stem cell transplantation~     (SCT). The purpose of this study is to explore the antileukemic, immunosuppressive effects~     and safety of FA as the backbone of a conditioning regiment for the treatment of patients~     with high-risk, recurrent or refractory acute Leukemia and advanced myelodysplastic syndrome.~   "
94599|NCT02328937|"~     This is a prospective, single site, unmasked, cross-over study with three silicone hydrogel~     contact lenses comparing central corneal swelling.~   "
94600|NCT02328924|"~     This study, prospective randomized controlled trial, tried to identify a cut off value of~     luteinizing hormone predictive of in vitro fertilization outcome in a fixed or flexible~     gonadotropin-releasing hormone antagonist protocols.~      202 norma-ovulatory women < 39 years were randomized to fixed or flexible group in GnRH~     antagonist protocols The follicular phase profile of luteinizing hormone, estradiol and~     progesterone in the two study groups was measured. Total number of retrieved oocytes,~     implantation and pregnancy rate were recorded.~   "
96256|NCT02307240|"~     This is a Phase I, open-label, multi-center trial designed to evaluate the safety,~     tolerability and pharmacokinetics of CUDC-907 administered orally to subjects with~     advanced/relapsed solid tumors.~   "
94604|NCT02328872|"~     Compass is a randomised controlled trial of primary HPV testing for cervical cancer screening~     in Australia. A pilot study involving 5,000 women was carried out in 2013-2014. The trial~     will involve recruiting 121,000 women from primary health clinics. Women aged 25-69,~     attending for cervical screening or for routine follow-up will be invited to participate in~     the 2-arm trial. A liquid-based cytology (LBC) sample will be taken from consenting women and~     sent to VCS Pathology. Women will be randomised in a 1:2 parallel group allocation to LBC and~     HPV arms using randomisation with the minimisation procedure, with stratification by birth~     cohort according to whether offered HPV vaccination in Australia's national publicly-funded~     HPV vaccination program (date of birth >=July 1st 1980 and <1st July 1980). In the LBC~     (active control) arm, women will undergo 2.5 yearly image read cytology screening with reflex~     HPV triage testing for low grade cytology. In the HPV (intervention) arm women will undergo 5~     yearly HPV screening with partial genotyping enabling separate identification of HPV16 and~     HPV18 and referral of this group for diagnostic evaluation, and secondary randomisation of~     intermediate risk women testing positive for oncogenic HPV (but not HPV 16 or 18) to either~     image read LBC screening or dual-stained (DS) cytology testing with p16/Ki67. The laboratory~     reports issued to practitioners will specify the recommended management for women, according~     to study arm and test results.Participating women will be flagged on the Victorian Cervical~     Cytology Registry (VCCR) and clinical outcomes will be tracked via the VCCR. Data linkage~     between the VCCR and the National HPV Vaccination Program Register will be performed in order~     to integrate vaccination and screening histories for trial participants. Participants will be~     followed for an anticipated 5 years from the time of recruitment and the primary outcome is~     based on the total cumulative detection of CIN3+ after exit testing at 5 years.~   "
94605|NCT02328859|"~     A custom designed Virtual Gait Retraining System (VGRS) is being adapted for balance and~     mobility rehabilitation in individuals with transtibial amputation. The system is composed of~     a treadmill that can simulate different environmental situations such as walking up stairs~     and hills and going around curves. The treadmill is synchronized with an immersive display~     and an avatar of the user. The combination of variable terrain and visual feedback is~     extremely promising as a means for amputee patients to achieve improved functional mobility~     after gait training. The proposed work is relevant to public health because it is the first~     step in developing a novel rehabilitation system that will use visual feedback for gait~     training in amputees and others with pathological gait disorders. The research is pertinent~     to the mission of the Department of Veterans Affairs which is committed to improve the~     quality of life of Veterans with disability.~   "
94606|NCT02328846|"~     Evaluation of the microcirculation is currently limited. Continual assessment of the tissue~     carbon dioxide-arterial carbon dioxide (PtC02-aCO2) offers a new, novel and noninvasive~     method of determining the state of the microcirculation. The investigators will apply two~     non-invasive devices, the Braedius sidesteam darkfield microscopy (SDF) microscopy device to~     the sublingual circulation and the transcutaneous PtC02 probe to the forehead in subjects~     undergoing cardiac surgery with cardiopulmonary bypass. The PtC02-aCO2 gradient will be~     determined and correlated with the videomicroscopic images of the sublingual~     microcirculation. Thereafter the incidence of postoperative organ failure and acute kidney~     injury will be determined and correlated with PtC02-arterial CO2 gradient and~     videomicroscopic images.~      Data will be analyzed by standard descriptive statistical methods.~   "
94607|NCT02328833|"~     The aim of this study is to evaluate the effects of an active multifactor implementation~     process of a Computerized Depression Guideline in Primary Care. The CPG-DEPc use use, the key~     outcomes and its maintenance over time in patients and professionals will be analyzed.~   "
94608|NCT02328820|"~     This study evaluates the prognostic value and therapeutic potential of combined pressure and~     flow measurements when evaluating a coronary artery stenosis. Lesions with intact coronary~     flow reserve (CFR) despite a reduced fractional flow reserve (FFR) will receive optimal~     medical therapy. Only lesions with a simultaneous reduction in both CFR and FFR will be~     treated with percutaneous coronary intervention (PCI).~   "
94609|NCT02328807|"~     The main purpose of this study is to evaluate the safety and efficacy of focal (targeted)~     Radio-Frequency Ablation (RFA) in men with low or intermediate-risk, clinically localized~     prostate cancer.~   "
94610|NCT02328794|"~     Using the NIH-funded Way to Health platform, the investigators will conduct this smoking~     cessation RCT among Vitality/Discovery beneficiaries. The investigators will be able to~     determine the effectiveness of 4 different interventions aimed at smoking cessation, two of~     which are incentive structures that are each grounded in behavioral economic principles. The~     other interventions will determine the effectiveness of various cessation aids, including~     electronic cigarettes and text messaging, on smoking cessation. This study will be conducted~     as an opt-out procedure where participants are automatically enrolled in the program but have~     the choice to unenroll if they so chose. This pragmatic approach will allow us to investigate~     the effects of such programs in an employee based population that can be easily mimicked in~     other employee based populations.~   "
94611|NCT02328781|"~     The purpose of this study is to evaluate the safety and efficacy of Firehorus vertebral~     artery rapamycin-target-eluting stent system (hereinafter referred to as Firehorus) in~     treatment of symptomatic vertebral artery stenosis.~   "
94612|NCT02328768|"~     The overall purpose of this study is to determine if replacing standard soybean oil based fat~     emulsions with Omegaven®, a fish oil based fat emulsion, can reverse or prevent the~     progression of parenteral nutrition associated liver disease. It is a compassionate use~     protocol for patients who already have significant liver disease related to parenteral~     nutrition.~   "
94613|NCT02328755|"~     This protocol is an open label, single arm, non-randomized, phase I / II clinical trial~     investigating the use of pegylated interferon alpha-2a (peg-IFN-α, Pegasys®, Genentech) for~     prevention of relapse in acute myeloid leukemia (AML) not in remission at the time of~     allogeneic hematopoietic stem cell transplantation (HCT).~   "
94614|NCT02328742|"~     The main objective of this study is to describe the level of expression of the biological~     factors involved in the formation of adhesions (Transforming growth factor beta, Activin A,~     inhibin) at the time of a first diagnostic hysteroscopy among women with synechia, another~     intracavitary disease or no intracavitary disease.~   "
94642|NCT02328378|"~     The Quadratus Lumborum block (QLB) was first described by Blanco in 2007. The main advantage~     of QLB compared to the Transversus Abdominis Plane block (TAP) is the extension of local~     anesthetic agent beyond the TAP plane to the thoracic paravertebral space. The wider spread~     of the local anesthetic agents produces extensive analgesia and prolonged action of the~     injected local anesthetic solution.~      Previous studies showed that TAP block may not be effective in improving postoperative~     analgesia in patients who had cesarean section under spinal anaesthesia.~      The aim of this randomised controlled, double blinded study is to examine the effect of QLB~     on the postoperative pain management in patients who had cesarean section under spinal~     anesthesia.~   "
94615|NCT02328729|"~     Incident and extent of pulse alteration during administration of various modes of local~     anesthesia in children during routine dental treatment. Our aims are: (1) To estimate the~     percent of patients who receive mandibular block , C-CLAD-IL or infiltration injections and~     show increase in their pulse rate during the delivery of anesthesia (in spite of negative~     aspiration) as result of infiltration of adrenalin into their blood vessels. (2) To estimate~     the extent of pulse rate alteration in correlation with the velocity or volume of local~     anesthesia injected. (3) To examine the correlation between increase in the pulse rate and~     effectiveness of anesthesia. (4) To examine the correlation between the needle gauge (27 &~     30) and increase in pulse rate during mandibular block injection in spite of negative~     aspiration. We will recruit children that undergo routine dental treatment under local~     anesthesia (such as mandibular block, infiltration or C-CLAD-IL). Patients will be connected,~     immediately before and during the entire delivery of the local anesthetic, to pulse-oximeter~     that will be connected to a computer and continuously monitor pulse rate and saturation~     during the delivery of local anesthesia. Each aberrant event which may occur during~     alteration of the pulse rate such as gag reflex, coughing, or pain related disruptive~     behavior will be documented on the computer in real time by another person that is not the~     treating dentist. All types of local anesthesia delivery will be performed by the~     computerized-controlled local anesthesia delivery system - Single-Tooth-Anesthesia which~     connected to a computer and documents continuously the amount and velocity of the local~     anesthetic delivered to the patient. All injections will be performed by using a 29 gauge~     needle, except when children will be treated under general anesthesia, the injection will be~     performed also by 27 gauge needle. In case the pulse rate will increase to 150% of the~     baseline rate, or when the pulse will reach 150 beats/minute the injection will be stopped~     immediately. The continuation of the local anesthetic delivery will be continued in different~     location and only after the return of the pulse to its basic rate. A total of 100 patients~     will receive local anesthetic containing 1:100,000 adrenalin and 50 patients without~     adrenaline. Three modes of local anesthesia will be evaluated: C-CLAD-IL, infiltration and~     mandibular block= a total of 300 patients.~   "
94616|NCT02328716|"~     The purpose of this clinical trial is to Investigate whether the administration of HIPEC with~     Cisplatin (75 milligrams per square meter of body surface) after surgical cytoreduction in~     women with ovarian, tubal or primary peritoneal carcinoma increased disease-free survival~     period compared with patients without HIPEC treatment.~   "
94617|NCT02328703|"~     This is a prospective, randomized, double-blind, placebo-controlled, repeated measures study~     with intention-to-treat that involves exposure to Reiki therapy or a placebo control~     intervention for a total of six treatments, three treatments per week for two weeks, with a~     2-week follow-up for the decrease of neuropathic pain in extremity trauma.~   "
94618|NCT02328690|"~     The purpose of this prospective, double-blind, repeated measures study is to assess the~     efficacy of Binaural Beat Technology (BBT) on anxiety and anxiety related cardiovascular~     measures as well as to assess the feasibility of implementing a BBT intervention in a~     military population during the high risk post-deployment window.~   "
94619|NCT02328677|"~     ColoCare is an international prospective cohort study of stage I-IV colorectal cancer~     patients (ICD-10 C18-C20).~   "
94620|NCT02328664|"~     After endoscopic removal of a colorectal polyp that harbors (unexpected) adenocarcinoma,~     pathology usually can not guarantee a radical resection from an oncological point of view. In~     such case, additional surgical resection is advised. However, only in 15% of patients,~     residual adenocarcinoma is found. This study investigates the sensitivity of biopsies from~     the polypectomy scar for residual adenocarcinoma.~   "
94621|NCT02328651|"~     This is a single-blinded randomized trial aiming to evaluate the effectiveness of Xiaoer~     Jiebiao Oral liquid in combination with Ribavirin treatment on patients with hand-foot-mouth~     disease compared with the controlgroup that recieve only libavirin treatment.~   "
94622|NCT02328638|"~     The purpose of the proposed study is to develop and pilot test a manual-based,~     interdisciplinary intervention for youth, ages 3 to 10 years, with autism spectrum disorder~     (ASD) and overweight called the Changing Health in Autism through Nutrition, Getting fit, and~     Expanding variety (CHANGE) obesity program.~   "
94623|NCT02328625|"~     This registry study will assess the safety and performance of the Celution Device in the~     processing of an autologous graft consisting of adipose derived regenerative cells (ADRCs) in~     the treatment of hand scleroderma.~   "
94624|NCT02328612|"~     Phase I, randomized, parallel group, placebo control, unicentric, interventional study.~     Thirty two healthy male volunteers aged between 18-35 years will be randomized into the eASCs~     or placebo group if they meet all the inclusion criteria at a 3:1 ratio.~      The treatment administration will be infused intravenously to the following groups after~     randomization:~        -  First arm: 250,000 cells/kg~        -  Second arm: 1 million cells/kg~        -  Third arm: 4 million cells/kg~        -  Fourth arm: placebo according to their weight.~      An hour after the end of the eASCs administration, all subjects will be given an intravenous~     dose of LPS. Subjects will be allowed to leave in the evening once deemed clinically stable~     by the investigator.~   "
94625|NCT02328599|"~     Initially, 4 teams of investigators conducted randomized controlled trials (RCT) at their own~     site to evaluate the effectiveness of bariatric surgery compared to medical/lifestyle~     management of type 2 diabetes. Each study followed subjects for a duration of about 1 - 3~     years. Following this, a consortium was created to pool data and continue to follow study~     participants. This early collaboration of the 4 groups of investigators was supported by~     Industry sponsors (Ethicon, Inc and Medtronic-MITG). Now, the investigators have successfully~     received a grant from the NIH, as the sole supporter of continued observational follow-up of~     study participants.~      The continuing aim of this study is to combine data from the 4 studies and follow the~     original randomized subjects for an additional 5 years of follow-up. The purpose of the study~     is to determine the longer term durability and effectiveness of bariatric surgery compared to~     medical/lifestyle intervention on the treatment of type 2 diabetes.~   "
94626|NCT02328586|"~     This research project will test the feasibility and effectiveness of group acupuncture for~     the treatment of musculoskeletal pain (back pain, shoulder pain, neck pain and/or~     osteoarthritis).~   "
94627|NCT02328573|"~     The study will focus on the impact of communal singing on patients with stroke and their~     personal caregivers. Forty post-stroke patients will be randomly assigned to two groups: the~     first group of 20 stroke survivors and their caregivers (up to 40 total participants) will~     receive 6 months (approximately 24 sessions) of music therapy. The second control groups of~     20 stroke survivors and their caregivers will receive standard post-stroke care~   "
94643|NCT02328365|"~     More than one third of patients with colorectal cancer (CRC) suffer from comorbidity such as~     heart and lung diseases. This comorbidity markedly impairs survival after surgical treatment~     owing to increased mortality within the first weeks to months after surgery. Since the~     operation itself constitutes a severe challenge to the patient's cardiopulmonary system, this~     study aims to elucidate whether a more systematic perioperative management and follow-up of~     colorectal cancer patients with cardiopulmonary comorbidity may improve their outcome as~     measured by complications, hospitalisation times, and survival.~   "
96284|NCT02306876|"~     This study is designed to investigate the safety, tolerability pharmacokinetics and~     pharmacodynamic effects of PF-06412562 following multiple dose administration as MR tablets~     in healthy adult males.~   "
94628|NCT02328560|"~     The project aims primarily to measure the expected paramedic consultation announcement~     benefits for the patient, at different levels. It will measure improvements in the management~     of patients treated with chemotherapy. Indeed, paramedical consultation ad aims to provide a~     better understanding of the disease and treatment incurred, which should lead to the~     implementation of joint strategies between the healthcare team and the patient to prevent the~     effects of and treatment of the disease by the patient and caregivers.~      This improvement is to promote the fair treatment by reducing patient anxiety and / or carers~     and involving them in the management of their disease. In this context, it is shown a profit~     of paramedical consultation for the patient, it will work, based on the recommendations of~     the Cancer Plan, strengthen the need to routinely offer paramedic Ad consultation.~      This work should also help measure the impact of ad paramedical consultation on optimizing~     care consumption off-line therapy and to assess the associated costs.~      For patients who received paramedic ad or not consultation, it will therefore be of~     particular compare intercurrent hospitalizations, commuting structure of care, the number of~     consultations with the doctor, the reports of cure, additional biological monitoring or other~     health care consumption.~      With the participation of several centers in the fight against cancer, this study will~     provide valuable information on the practice of paramedical consultation ad in several tumor~     sites.~      It will objectify the benefit provided by the Medical device announcement for both patients~     and the organization and use of care prerequisite to encourage better integration of this~     device in the course of patient care, the consultation paramedical ad remaining poorly~     understood by many health professionals.~   "
94629|NCT02328547|"~     The objectives of this study are (1) to determine the efficacy of fecal microbiota~     transplantation (FMT), given as oral capsules, compared with placebo for the treatment of~     refractory diarrhea-predominant irritable bowel syndrome (IBS-D); (2) determine the impact of~     FMT on the intestinal microbiome of patients with IBS-D; and (3) assess the safety,~     feasibility, and tolerability of FMT for patients with IBS-D.~   "
94630|NCT02328534|"~     The investigators evaluate the feedback of using swim down semen processing method during~     preparation for ICSI and compare the results of pregnancy and embryos quality with the cases~     used density gradient method for their semen processing.~   "
94631|NCT02328521|"~     The investigators aim to investigate the effect of oral nicorandil on neointima after~     coronary drug-eluting stent implantation in patients with diabetic mellitus.~   "
94632|NCT02328508|"~     This study evaluated the effect of hyperbaric oxygen therapy (HBOT) on wound healing,~     inflammation index, glycemic control, amputation rate, survival rate of tissue, bacterial~     wound cultures, and quality of life (QOL) in diabetic foot ulcer (DFU) patients with~     diabetes.~   "
94633|NCT02328495|"~     The aim of this study is to compare the effectiveness of misoprostol versus uterine~     straightening by bladder filling for pain relief in menopausal patients undergoing office~     hysteroscopy.~   "
94634|NCT02328482|"~     This will be a multi-center, randomized withdrawal, open-label, non-treatment concurrent~     control, parallel group study. Patients completing protocol BBCO-001 will be offered the~     opportunity to enter into this 12-month randomized withdrawal protocol.~   "
94635|NCT02328469|"~     The main objective of this study is:~        -  to establish etiology of acute aseptic meningitis/meningoencephalitis in Slovenia~        -  to assess the clinical course and outcome of tick-borne encephalitis and Lyme~          neuroborreliosis~        -  to characterize the inflammatory proteins, gene polymorphisms, and transcriptome~          profiles in patients with tick-borne encephalitis and Lyme neuroborreliosis~   "
94636|NCT02328456|"~     The purpose of the study is to use a randomized controlled design to determine the impact of~     a SMS messaging associated with free eye drops intervention on the following outcomes among~     patients after trabeculectomy surgery in rural China.~   "
94637|NCT02328443|"~     Evaluation and validation of metabolic markers for the assessment of CYP3A activity and~     prediction of drug-drug interaction in Korean healthy subjects.~   "
94638|NCT02328430|"~     Comparison of standard spirometry to non invasive remote lung function measures of chest wall~     movement using depth camera technology.~   "
94639|NCT02328417|"~     Prospective non randomized study of two cohorts: usual protocol and the application of~     accelerated recovery protocol. F/up after discharge, 90 days and thereafter according to~     protocol of each center. Compliance to be assessed.~   "
94640|NCT02328404|"~     This is a prospective double-blind, randomized, parallel-group, placebo-controlled trial~     designed to examine the effect of supplementation with 50,000 IU vitamin D3 for 3 months on~     Polycystic Ovary Syndrome (PCOS) prognosis, serum 25-Hydroxy Vitamin D (25(OH)D) level, serum~     chromium level, insulin resistance, and Body Mass Index (BMI), in 60 overweight Jordanian~     female patients diagnosed with PCOS and with hypovitaminosis D.~   "
94641|NCT02328391|"~     OBJECTIVE study the effectiveness of the administration of Erlotinib 150 mg/Day v.o. in~     second-line treatment in patients with lung cancer advanced non-small of histology~     predominantly flaky by assessing the survival free of progression (SLP).~      Design Studio postautoritation of multicenter observational follow-up prospective (EPA-SP)~     type.~      DISEASE OTRASTORNO A study of cell Lung Cancer not small (NSCLC). MEDICATION object data to~     study the drug under study is erlotinib.~      -Dose and treatment guidelines follow the corresponding product sheet. Management of dosage~     and adverse effects specified in point H. 15 of the Protocol.~      POPULATION in study and number TOTAL of subjects population under study: adult patients with~     diagnosis of NSCLC with predominantly squamous histology total number of subjects: the~     participation of approximately 51 patients is expected DISEASE OR DISORDER TO STUDY Non Small~     Cell Lung Cancer (NSCLC). MEDICATION DATA OBJECT OF STUDY The drug under study is erlotinib.~      -Dose and treatment guidelines Follow the corresponding product sheet. Management of dosage~     and adverse effects specified in point H. 15 of the Protocol.~      STUDY POPULATION AND NUMBER TOTAL OF SUBJECTS Study: adult patients with diagnosis of NSCLC~     with predominantly squamous histology total number of subjects: the participation of~     approximately 51 patients is expected.~   "
94769|NCT02326688|"~     Reproducibility assessment of a quantitative measure of the amount of trunk compensation by~     kinematic analysis in a grasping task in stroke patients.This maladaptive trunk~     compensation is suspected to be underlined by arm non-use in some patients, since this~     abnormal movement impairs the ability of patients to correctly flex their shoulder and extend~     their elbow during grasping.~   "
94644|NCT02328352|"~     Nanotechnologies applied to General Surgery and Emergency Surgery: The Buckypaper as a new~     fixing method for prosthetic materials in the treatment of abdominal wall hernias in humans,~     in laparotomic procedures and as a new device for the treatment of solid cancer and~     hematopoietic system tumors.~      The experimentation on this new material, preliminary conducted on breed female rabbit New~     Zeeland, will be applicable to human, if the results in terms of toxicity and durability will~     be comfortable.~   "
94645|NCT02328339|"~     The study will explore the benefit of tea for microcirculation. Subjects will consume tea ar~     a placebo matched for taste and appearance in a blinded cross over design.~   "
94646|NCT02328326|"~     This trial will compare two methods of increasing engagement in care and success in diabetes~     management, among patients with diabetes with high-risk features, who also have family~     members involved in their care.~   "
94647|NCT02328313|"~     To determine if exercise will affect the increase in p16 expression that is associated with~     both chemotherapy administration and advancing age.~   "
94648|NCT02328300|"~     This is a single arm, single center study of 15 patients with brain lesions being treated at~     UNC Hospitals. Subjects will undergo one (1) FLT-PET-MRI scan before their scheduled surgical~     biopsy of their brain lesion(s).~   "
94649|NCT02328287|"~     Failed fusion and failure to relieve back pain following spinal fusion are still frequent,~     irrespective of the type of procedures or grafts used by the surgeon. Moreover, revision~     surgeries are unfortunately associated with higher procedure-related complication rates,~     technical difficulties, longer operative time, and quite disappointing and unreliable success~     rates for both fusion and clinical results.~      The present Phase 2a study aims at demonstrating the safety and efficacy of ALLOB®, a~     proprietary population of allogeneic osteoblastic cells, in rescue interbody fusion.~   "
94650|NCT02328274|"~     Laparoscopic subtotal hysterectomy (LASH) for benign uterine lesion has regained its~     popularity in the past decade due to its minimal invasiveness that results in less operation~     time, less blood loss and quicker return to normal activity. The standard surgical procedure~     in LASH includes separation of adnexa and round ligament from pelvic sidewall or uterus,~     dissection of the vesico-uterine peritoneum and opening of the paravesical space; followed by~     amputation of the uterus with energy-producing modalities (such as Harmonic Scalpel,~     monopolar electrocautery, bipolar electrocautery). Large uteri may result in longer operative~     time and higher possibility of conversion to laparotomy due to technical difficulty and~     excessive blood loss. In order to overcome these difficulties, we introduce a modified~     surgical technique of LASH which incorporated two methods of vessels ligation and~     laparoscopic in situ morcellation.~   "
94651|NCT02328261|"~     This is a phase 2 study to evaluate the efficacy of single-agent icotinib in patients with~     advanced nasopharyngeal carcinoma.~   "
94652|NCT02328248|"~     The purpose of this study is to observe the effective and safety in the laparoscopic repair~     of hiatal hernia using biological patch versus plastic.~   "
94653|NCT02328235|"~     Skeletal muscle burns a significant amount of the fat and sugar that circulates in the blood~     stream. Ideally, when sugar is elevated in the blood stream, the muscle will either use it to~     make new energy or store it for later use. Likewise, for fatty acids. Skeletal muscle of~     obese and diabetic humans has been shown to inadequately use either sugar or fatty acids when~     they increase in the blood stream, and this has been termed metabolic inflexibility. The~     cause of metabolic inflexibility is not known, but it is believed that eating more fat than~     the body needs for energy may be a contributing factor. Metabolic inflexibility in skeletal~     muscle is bad because if the muscle does not use the sugar or fat, it will be stored~     elsewhere in the body and potentially lead to obesity and the resistance to insulin. The~     investigators have performed a research study with nonobese, healthy humans during which we~     fed them a high fat diet for 5 days. Interesting, only 5 days of a high fat diet is~     sufficient to cause the skeletal muscle to become metabolically inflexible just like that~     observed in obese and diabetic humans. The investigators are proposing addition studies to~     feed healthy humans a high fat diet for 5 days in effort to better understand what causes~     metabolic flexibility. The investigators are speculating that a high fat diet causes the~     intestines to release a substance called endotoxin that causes muscle to become metabolically~     inflexible. The investigators will test this notion in our proposed studies.~   "
94654|NCT02328222|"~     BACKGROUND: Non-steroid maintenance immunosuppression after transplantation can improve~     long-term lipid and hemodynamic profiles without severe acute rejection (AR) events that~     alter graft function or survival. Our objective was to evaluate the effects of early steroid~     withdrawal (ESW) on the frequency and severity of AR using an immunosuppressive scheme~     consisting of mycophenolate (MMF) and tacrolimus (TAC) in combination with an induction~     treatment with basiliximab.~      METHODS: A randomized clinical trial was performed on first renal transplant recipients. In~     the ESW group, patients were selected for corticosteroid treatment withdrawal on the fifth~     day post-transplantation. In the Control group, patients continued steroid treatment.~   "
94655|NCT02328209|"~     Recently studies have shown that intravitreal injection of ranibizumab is effective for age~     related macular degeneration. However there are problems about injection regimen of~     maintenance phase. We plan to perform new simplified treat and extend regimen using~     ranibizumab.~   "
94656|NCT02328196|"~     The McGill Ingestive Skills Assessment (MISA) for measuring dysphagic clients' functional~     performance during meals has been previously translated into Danish (MISA-DK) and this~     translated version validated. Critical issues about the construct validity of the scale, per~     se, had been raised. Consequently, major revisions of the MISA-DK have been undertaken, which~     necessitates a new validation process. Therefore, the purpose of this study is to evaluate~     the construct validity of a revised version of the MISA-DK when used amongst dysphagic adults~     in hospitals settings and community services.~   "
94657|NCT02328183|"~     The objective of the study is to evaluate the efficacy of Polymyxin B for treatment Gram~     negative bacterial infection. The hypothesis of study is Polymyxin B would be the new~     antibacterial agents for Thai Gram negative infected patients in case of desirable outcomes~     and minimal side effects.~   "
94658|NCT02328170|"~     The purpose of this study is to determine the correlation of specific IgE levels to common~     foods and aeroallergens measured by EUROIMMUN Allergy and ImmunoCap~   "
96285|NCT02306863|"~     This study will evaluate whether whole-body vibration applied over a 12-week period is~     effective in treating motor symptoms of Parkinson's disease.~   "
94659|NCT02328157|"~     Toric intraocular lens (IOL) is now widely used for the cataract surgery with preoperative~     corneal astigmatism.~      Symptomatic epiretinal membrane (ERM) is often treated with 25-gauge transconjunctival~     sutureless vitrectomy, resulting in good visual recovery. So far, however, limited~     information is available on the the stability of axis rotation, astigmatism correction, and~     improvement in uncorrected distance visual acuity, using astigmatism-correcting IOL in a~     25-gauge transconjunctival sutureless vitrectomy combined with cataract surgery. In the~     current study, eyes with a preoperative corneal cylinder of more than 0.75 diopter had a~     triple procedure for idiopathic ERM using a toric IOL. Outcome measures will be the amount of~     IOL axis rotation, uncorrected visual acuity, corrected distance visual acuity, and corneal~     and refractive astigmatism up to 6 months postoperatively. We are expecting to show that~     postoperative IOL axis stability is similar to that reported for cataract surgery alone in~     vitrectomy (triple procedure) for idiopathic ERM with a toric IOL.~   "
94660|NCT02328144|"~     Hemorrhoidal disease occurs in 50% of people over 40 years old and is the most common cause~     of anorectal surgery. One of the complications of hemorrhoidectomy is pain, which is a~     difficult symptom to appreciate and assess, by its frequent and large variations in~     sensitivity in each patient. Many studies have been done to reduce patient postoperative~     pain, but there is no ideal method. The application of both oral and topical metronidazole~     has shown to decrease pain following hemorrhoidectomy, but its use is not standardized.~      The investigators evaluated the effect of oral administration of metronidazole versus~     homologated placebo in pain control after hemorrhoidectomy~   "
94661|NCT02328131|"~     The great diversity of regimens and treatment lines, the different efficacy of these, mostly~     due to the increase in bacterial antibiotic resistance and regional differences, requires a~     continuous critical analysis of clinical practice, evaluating systematically the efficacy and~     safety of the different regimens and the cost-effectiveness of the different~     diagnostic-therapeutic strategies. This will help in the design of an efficient and optimized~     treatment that will reduce number of re-treatments, diagnostic tests and the appearance of~     associated pathologies such as peptic ulcers, gastrointestinal bleeding and, probably,~     gastric cancers. Therefore, the evaluation of real clinical practice using~     non-interventionist registries will help to improve the design and organization of European~     Consensus on the management of H. pylori infection, which is the best way to establish~     healthcare efficiency.~      Primary aim~      To obtain a database registering systematically over a year a large and representative sample~     of routine clinical practice of European gastroenterologists in order to produce descriptive~     studies of the management of H. pylori infection.~      Secondary aims~        1. To evaluate H. pylori infection consensus and clinical guidelines implementation in~          different countries.~        2. To perform studies focused on epidemiology, efficacy and safety of the commonly used~          treatments to eradicate H. pylori.~        3. To evaluate accessibility to healthcare technologies and drugs used in the management of~          H. pylori infection.~        4. To allow the development of partial and specific analysis by the participating~          researchers after approval by the Registry's Scientific Committee~      Methodology Non-interventionist prospective multicentre international registry promoted by~     the European Helicobacter Study Group. A renowned gastroenterologist from each country was~     selected as Local Coordinator (30 countries). They will in turn select up to ten~     gastroenterologists per country that will register the routine clinical practice~     consultations they receive over 10 years in an electronic Case Report Form (e-CRF). Variables~     retrieved will include clinical, diagnostic, treatment, eradication confirmation and outcome~     data. The database will allow researchers to perform specific subanalysis after approval by~     the Scientific Committee of the study.~   "
94662|NCT02328118|"~     Proliferative diabetic retinopathy(PDR) is the leading cause of visual loss in diabetic~     patients. Operation is an efficient method to treat PDR. Anti-vascular endothelial growth~     factor (anti-VEGF) can be used as an adjuvant therapy which can make operation more easy.~   "
94663|NCT02328105|"~     ABRAXANE, based on results from prior studies, is a promising drug in squamous cell carcinoma~     of the lung. This study will help to explore the combination of ABRAXANE and carboplatin more~     thoroughly in the subgroup of patients who had the best response in prior studies as well as~     determine whether there are any biomarkers which can predict for response.~   "
94664|NCT02328092|"~     The purpose of this study is to assess the efficacy of daily sacral root magnetic stimulation~     for 10 sessions in patients with nocturnal enuresis.Eligible patients were randomized to~     receive either real or sham repetitive sacral root magnetic stimulation (rSMS; 15 Hz with a~     total of 1500 pulses/session) for 10 sessions. Evaluation was performed before starting~     treatment, immediately after the 5th and 10th treatment session, and 1 month later, using~     frequency of enuresis/week, visual analogue scale (VAS) and Quality of life. Cortical~     excitability of upper and lower limbs were done before and after the end of sessions.~   "
94665|NCT02328079|"~     The purpose of this study is to assess the efficacy of antiviral medicine (acyclovir) in~     complete recovery of facial Palsy. Fifty patients (Males and females) with acute Facial Palsy~     within the first 3 days of onset with age ranged from 15-60 years old. Each patient submitted~     to the following clinical evaluation using House and Brackmann6 facial function scoring~     system and Synnybrook grading system neurophysiological assessment of facial nerve and~     muscles before and after the end of treatment and then after the end of first and second~     month of treatment. EMG will be done for facial muscles of both sides beside measuring facial~     nerve excitability to determine the excitation threshold by recording the minimum electrical~     stimulus required to produce visible muscle contraction. A difference greater than 3.5 mA~     between the affected and unaffected side is considered to be significant in terms of poor~     prognosis. Nerve conduction study of facial nerves of both sides using concentric needle~     electrode. Trigeminal Blink reflex for both side of the face. Facial functional recovery was~     defined as good or complete using the same criteria used in the 2001 practice guideline.~     Using the House and Brackmann6 facial function scoring system, we considered an outcome of~     grade I or II a good recovery.~   "
94666|NCT02328066|"~     The purpose of this study is to evaluate the diagnostic accuracy of NICE classification to~     predict deep submucosal invasion of colonic polyps > 1 cm, considering histology as the gold~     standard, in a group of endoscopists who previously performed a training program.~   "
94667|NCT02328053|"~     The study is a randomised control trial to assess the visual and clinical outcomes of~     collagen cross linking in fungal keratitis. Fungal keratitis is a major cause of corneal~     blindness in India and the therapeutic options available are minimal to handle the advanced~     complications and sequalae caused by the disease.The antimicrobial and tissue remodeling role~     of corneal cross linking was demonstrated by several studies earlier,we anted to specifically~     assess the role of corneal cross linking in non resolving fungal keratitis in prevention of~     perforation and enhancement of healing process.~   "
94717|NCT02327377|"~     Functional abdominal pain (FAP), a pediatric pain condition without significant organic~     pathology, is a precursor to chronic pain and high healthcare utilization in young adulthood.~     This project aims to identify child and family characteristics that predict differential~     responses to a Cognitive Behavior Therapy intervention administered online to patients with~     FAP and their parents. The goal is to acquire scientific knowledge to guide individualized~     treatment of patients with FAP.~   "
94668|NCT02328040|"~     There are many recent advances in insulin treatment of type 1 Diabetes Mellitus (Type 1 DM),~     however after a meal sugars are always a concern. There is a drug sitagliptin (Januvia) which~     is FDA approved to treat people with type 2 diabetes which helps correct their glucose~     (sugars) after meals. This study is going to test whether this drug can improve the after~     meal sugars in people with type 1 diabetes. To test this, you will be given a mixed meal and~     its effects on insulin levels. The hormones that affect blood glucose as well as your sugar~     levels will be measured by a series of blood tests. We will also look for high blood sugars~     which might occur because of food staying longer in the stomach than usual or due to the~     suppression of a hormone called glucagon which increases blood sugar. If you qualify, you~     will be given sitagliptin (Januvia) 50 mg and 100 mg dosages. You and the researchers will~     not know which dose you are taking at any single visit. We will first enroll 10 subjects with~     established type 1 Diabetes Mellitus for at least 1 year, between the ages of 18-30 years~     old. The first 10 patients will be evaluated for safety parameters such as ability to keep~     blood sugars < 70 mg/dl for at least 70% of the time, no episode of severe hypoglycemia (low~     blood sugars) and so on. After this safety criteria is established, we will then recruit~     subjects between the ages of 14-19 yrs for the next phase of the study. A total of 17~     subjects will be enrolled into the study.~   "
94669|NCT02328027|"~     The objectives of the study are:~      Primary objective:~      - To determine the safety and tolerability of medical imaging with 99mTc-rhAnnexin V-128~      Secondary objectives:~        -  To determine the biodistribution, pharmacokinetics and radiation dosimetry of~          99mTc-rhAnnexin V-128~        -  To demonstrate the time-dependant distribution and localization of 99mTc-rhAnnexin V-128~          both in RA and AS patients~        -  To determine ability of early imaging with 99mTc-rhAnnexin V-128 to evaluate the~          presence of lesions before and after short term treatment of either RA or AS patients.~      Study hypothesis:~      99mTc-rhAnnexin V-128 could be used as an adjunct for the diagnosis of early stage rheumatoid~     arthritis and ankylosing spondylitis and for the assessment of response to treatment of these~     diseases.~   "
94670|NCT02328014|"~     This study is evaluating the safety, pharmacokinetics (PK), pharmacodynamics (PD), and~     efficacy ACP-196 and ACP 319 in B-cell malignancies.~   "
94671|NCT02328001|"~     This study performs a single intervention of informing endoscopists how much the disposable~     accessories cost following each procedure. Following this single and simple intervention,~     prospective analysis of EGD and colonoscopy accessory use and pathology specimen costs will~     be compared to the same resource costs during a control period where endoscopists are blinded~     to their observation.~   "
94672|NCT02327988|"~     This study propose investigate the effect of cryotherapy and laser therapy in response to~     strenuous exercise-induced muscle damage on the biceps brachii muscle (muscle of the arms).~     All the individuals underwent to an strenuous exercise protocol (2 series of 10 contractions~     of non-dominant elbow flexors) and three assessments (pre, post and 48hr after the exercise),~     composed of pain sensation, measure of the strength and muscle activation.~   "
94673|NCT02327975|"~     Physical inactivity is a health problem that affects people worldwide and has been identified~     as the fourth largest risk factor for overall mortality (contributing to 6% of deaths~     globally). Many researchers have tried to increase physical activity (PA) levels through~     traditional methods without much success. Thus, many researchers are turning to mobile~     technology as an emerging method for changing health behaviours.The study consists of a~     physical activity intervention through a mobile application in elderly. The study is a 3x2~     model, in which the sample is distributed in three study groups (over 53 years) and were~     evaluated at 10 weeks from baseline.~   "
94674|NCT02327962|"~     Chronic kidney disease (CKD) accelerates vascular stiffening related to age. Arterial~     stiffness may be evaluated measuring the carotid-femoral pulse wave velocity (PWV) or more~     simply, as recommend by KDOQI, monitoring pulse pressure (PP). Both correlate to survival and~     incidence of cardiovascular disease. PWV can also be estimated on the brachial artery using a~     Mobil-O-Graph; a non-operator dependent automatic device. The aim was to analyse whether, in~     a dialysis population, PWV obtained by Mobil-O-Graph (MogPWV) is more sensitive for vascular~     aging than PP.~      A cohort of 143 patients from 4 dialysis units has been followed measuring MogPWV and PP~     every 3 to 6 months and compared to a control group of non-CKD patients.~   "
94675|NCT02327949|"~     The purpose of this study is to determine whether this new W-Shaped Angular Plate is more~     effective and more safe to operate than the traditional reconstruction plate in the treatment~     of the posterior wall fracture of acetabulum.~   "
94676|NCT02327936|"~     The purpose of this study is to evaluate the tolerability of Fesoterodine and Oxytbutynin XL~     and to compare their efficacy for overactive bladder syndrome in children.~   "
94677|NCT02327923|"~     Comparison of intraoperative infusion of lidocaine and esmolol in the postoperative~     requirement of opioid for postoperative pain management after laparoscopic cholecystectomy to~     decrease opioid related side effects and enhance postoperative recovery with multimodal~     analgesia approach.~   "
94678|NCT02327910|"~     Three hundred aged(age>65y) patients were randomized to Commom group(C group). Qualitative~     TOF monitoring (TOF group). Qualitative TOF and transcutaneous partial pressure of carbon~     dioxide monitoring(Unite group). Anesthetic management was standardized in all subjects .The~     patients of C group were extubated when standard criteria were met; T group patients had a~     TOF ratio of greater than 0.90 as an additional extubation criterion;and U group patiens were~     extubated when TOF ratio is greater than 0.90 and meanwhile transcutaneous partial pressure~     of carbon dioxide recovered to preoperative ±5mmHg .All the patients were transport to the~     PACU after extubation.Compare the adverse respiratory events at the moment of extubation, on~     the arrival of PACU, at 30min and 60min moment in the PACU respectively.~   "
94718|NCT02327364|"~     The purpose of this 3-year, multi-site, non-randomized, prospective, observational study is~     to characterize the natural history of Pearson Syndrome. The Syndrome is a rare mitochondrial~     disorder due to a large-scale mtDNA deletion. Children typically present in their 1st two~     years of life (most in infancy) with anemia and/or pancreatitis. Most individuals with~     Pearson Syndrome die in childhood. Those who survive evolve to Kearns-Sayre Syndrome/Chronic~     Progressive External Ophthalmoplegia (KSS/CPEO) although accurate survival estimates are not~     yet known.~   "
94679|NCT02327897|"~     Background:~      - Asthma is a serious clinical and public health problem. Researchers want to collect data to~     better understand how bacteria and other things in the environment can affect people's~     asthma.~      Eligibility:~      - Nonsmoking adults age 18 - 60 who have moderate to severe asthma and are not pregnant or~     breastfeeding.~      Design:~        -  Partaicipants will complete a medical history form before the first visit.~        -  Study visits will include collecting medical history, and conducting physical exam, lung~          and smoking tests. Participants will give blood, urine, stool, dust, saliva, and sputum~          samples.~        -  Participants will take tests that measure their breathing abilities. They will give~          saliva samples for DNA study. They will get kits to collect stool and dust samples at~          home. They will fill out surveys.~        -  Participants will have visits every 6 months for 5 years. They can schedule sick visits,~          if needed, at no cost to the participant. For all visits, they will have asthma~          check-ups and get treatment, at no cost to the participant.~        -  Some participants may take part in a sub-study that includes one 4-hour visit. They will~          have medical history, physical exam, and lung tests. They will have urine tests to check~          for pregnancy and tobacco exposure. Then they will have bronchoscopy. For this, an~          intravenous line will be placed in an arm vein. The nose and throat will be numbed. A~          flexible fiber-optic tube will be inserted into their airways through the nose. Their~          airways will be examined and areas of their lung will be washed. A small sample of cells~          will be taken.~   "
94680|NCT02327884|"~     Background:~      - Salivary glands in and around the mouth and throat make saliva. Salivary gland disorders~     can affect a person s quality of life. Studying people who have a disease that affects their~     salivary gland(s) may teach researchers about the disorders and their genetics.~      Objectives:~      - To study salivary gland diseases and disorders. To collect data and samples from people~     with salivary gland problems and their relatives.~      Eligibility:~        -  People more than 4 years old who have or are suspected to have a disease involving~          salivary glands.~        -  Their relatives more than 4 years old.~        -  Healthy volunteers 18 years or older.~      Design:~        -  Participants may be screened with:~        -  Medical history~        -  Physical exam~        -  Blood and urine tests~        -  General oral and dental history and exam~        -  Saliva collection~        -  Eye exam and test for dry eyes~        -  Health questionnaires (adults)~        -  Biopsy of some minor salivary glands. A small incision will be made on the inside of the~          lower lip and several tiny salivary glands will be removed.~        -  Participants will have 2 3 visits. These may include:~        -  Repeats of some screening tests~        -  Ultrasounds of some glands. Researchers will put some gel on the face, then press on it~          with a smooth wand.~        -  Adults may have other biopsies~        -  A small catheter inserted into the opening of the parotid gland duct on the inside of~          the cheek. A saline solution (in a syringe) will fill the duct.~        -  Swishing a saltwater solution in the mouth for 10 seconds and then spitting into a cup~        -  Scrapings collected from teeth, tongue, and cheeks~   "
94681|NCT02327871|"~     To control patient's body temperature remains of major importance especially after cardiac~     arrest (CA). Therapeutic hypothermia (TH) targeted to 32-34°C is now recommended for most~     unconscious CA patients. However, available modalities for inducing TH have a number of~     technical (side effects), logistical (difficulties of placement), and financial (cost)~     barriers. The Esophageal Cooling Device (ECD) is a multi-chambered silicone heat exchanger~     placed in the esophagus providing highly efficient heat transfer to a patient. The ECD is a~     device that potentially improves the effectiveness of TH in minimizing the risks of existing~     methods (such as invasive cooling). Initial mathematical and animal studies have shown strong~     support for the efficacy and safety of the ECD. Placement of a naso-gastric probe is a~     systematic standard of care for all unconscious patients suffering from CA. The present study~     will replace the usual naso-gastric probe by the ECD that can be used for gastric suctioning~     as usually done in such patients.~      The aim of this prospective, interventional study is to assess the feasibility and safety of~     the ECD in resuscitated CA-patients and treated with 32-34°C targeted TH. The primary outcome~     is the feasibility of inducing, maintaining, and rewarming patients from TH using the ECD~     (cooling rate, rewarming rate, and the percent of time within goal temperature during the~     goal-temperature maintenance period). Evaluation of adverse events (including cardiac~     arrhythmias, severe bradycardia, myocardial infarction/re-infarction, dysphagia, odynophagia,~     aspiration pneumonia, non-aspiration pneumonia, esophageal reflux and injury, and~     esophagitis) will be closely monitored during the whole period of the targeted temperature~     management (secondary endpoint).~   "
94682|NCT02327858|"~     According to the World Health Organisation, depression and problem drinking are among the~     leading causes of disability worldwide. Most patients who present with problem drinking~     and/or depression have poor quality of life and pose a great economic burden to society due~     to their higher use of health services. We seek to develop a new, enhanced, efficient,~     innovative and cost effective treatment strategy aimed at reducing the burden that these two~     mental conditions impose on sufferers, their families as well as the community and health~     systems. In a recent pilot study of supportive text messages in Ireland conducted by the~     Principal Applicant and a team of researchers for patients with problem drinking and~     co-occurring depression, we established that patients who received twice daily supportive~     text messages for three months had significantly less depressive symptoms than those who did~     not receive such messages. There was also a trend that patients who received the supportive~     text messages were more likely to have higher alcohol free days than those who did not~     receive any supportive text messages.Our study was limited by the small number of~     participants and it did not examine the impact of the text messages on health services~     utilization. Our study did not also examine the effects of supportive text messages on those~     with only depression or only problem drinking. The proposed study seeks to extend the~     knowledge gained from the pilot study in Ireland by examining the impact of supportive text~     messages in the individual disorders~   "
94683|NCT02327845|"~     The goals of this study are: (1) to better understand the relationship between the phenotype~     and genotype of amyotrophic lateral sclerosis (ALS) and related diseases, including primary~     lateral sclerosis (PLS), hereditary spastic paraplegia (HSP), progressive muscular atrophy~     (PMA), and frontotemporal dementia (FTD); and (2) to develop biomarkers that might be useful~     in aiding therapy development for this group of disorders.~   "
94684|NCT02327832|"~     Patients eligible for this study include those with decompensated liver cirrhosis with a~     Child-Pugh score ≥7 (Child-Pugh B) in whom further improvement with current medical treatment~     is not expected. Other inclusion criteria are age 20 to 75 years and a serum total bilirubin~     of 3.0 to 5.0 mg/dL, or if the total bilirubin is <3.0 mg/dL, patients who are still deemed~     unsuitable as a candidate for general anesthesia. About 30 mL of autologous bone marrow was~     collected from the bilateral iliac crests under local anesthesia, heparin was added after~     collection. In addition, at the Center for Regenerative and Cell Therapy at Yamaguchi~     University Hospital, a nucleated cell fraction was prepared. Next, a cell suspension was~     prepared by adding culture medium, and this was inoculated into a culture flask. After~     subculturing for 3 weeks, the cells were infused through a peripheral vein. The primary~     endpoint is the incidence of adverse events up to 24 weeks after ABMSC infusion.~   "
94685|NCT02327819|"~     Supplementation of BCAA found to reduce the risk of developing liver cancer, but the affect~     of BCAA on existing liver cancer is unknown.~      The participants (post curative intent surgery) will be supplemented with either~     BCAA/non-BCAA-enriched protein supplement. The intervantion will go on for 2 years or until a~     new liver tumor is found.~   "
94686|NCT02327806|"~     Pulsed electromagnetic field therapy (PEMFT) is a reparative technique most commonly used in~     the field of orthopedics for the treatment of non-union fractures. The aim is to test the~     effect of the magnetic induction on brute force of treated muscle in oncological patients.~     Oncology patients were chosen as we assume that the ipmrovement will be more noticable in~     oncology patients than in a non-oncology, healthy subjects.~   "
94687|NCT02327793|"~     The purpose of this study is to provide a description of blood flow changes in the brain~     after blood pressure lowering drugs are given. This information will be used by physicians to~     guide blood pressure lowering therapy in stroke patients in the future.~   "
94688|NCT02327780|"~     Treatment of IBS is very problematic. Despite the wide range of pharmacological and~     non-pharmacological therapies, there is no universally accepted approach. In recent years,~     the low FODMAP diet has been developed, a dietary approach that aims to relieve the symptoms~     of IBS. FODMAPs (Fermentable Oligosaccharides, Di-saccharides, Mono-saccharides and Polyols)~     are a group of dietary sugars that may be poorly absorbed in the small intestine and~     fermented by bacteria to produce gas. Ingestion of FODMAPs may also result in alterations in~     fluid content in the colon and trigger functional gut symptoms in some individuals. This~     study aims to examine the effectiveness of the FODMAP diet in Israel in improving symptoms of~     IBS compared to the standard dietary advice.~   "
94689|NCT02327767|"~     The goal of this project is to test a device (Zondervan et al, 2013) that can provide active~     assistance for arm training for people in Vietnam with severe to moderate stroke, but that is~     also simple and does not rely on powered actuators. The hypothesis is that individuals with a~     severe chronic stroke, who exercise with a mechanically passive rehabilitation device, will~     have improved arm movement ability without experiencing an increase in arm pain.~   "
94690|NCT02327754|"~     The purpose of this study is to investigate the effect of topiroxostat on urinary albumin~     excretion and the safety in patients with early stage diabetic nephropathy and hyperuricemia~     with or without gout. Participants are randomized to placebo (n=20) or topiroxostat (n=40)~     for 28 weeks. The investigational drugs for this study are supplied by FUJI YAKUHIN CO., LTD.~   "
94691|NCT02327741|"~     1010 patients post stenting were enrolled to receive Plavix more than 12 months and less than~     that and rate of bleeding, complication and major cardiovascular adverse events ( MACE) were~     compared to evaluate safety and feasibility of long term Plavix therapy post stenting.~   "
94692|NCT02327728|"~     To evaluate the efficacy of different botulinum toxin A injection patterns in treating benign~     essential blepharospasm and to compare their influence on condition of eye surface .~   "
94693|NCT02327715|"~     This study evaluates generic emtricitabine(FTC) efficacy and safety in Chinese naive pregnant~     HBsAg positive patients in prevention of HBV vertical transmission. Single group patients~     were enrolled to receive emtricitabine till 24 weeks after delivery.~   "
94694|NCT02327702|"~     This study evaluates generic emtricitabine(FTC) efficacy and safety in Chinese naive pregnant~     chronic hepatitis B patients. Single group patients were enrolled to receive emtricitabine~     till 48 weeks after delivery.~   "
94695|NCT02327689|"~     This study evaluates generic emtricitabine(FTC) plus adefovir dipivoxil in Chinese naive HBV~     related cirrhosis patients. Patients were divided into 2 groups: compensated HBV related~     cirrhosis patients and decompensated HBV related cirrhosis patients.~   "
94696|NCT02327676|"~     This study evaluates generic emtricitabine(FTC) in Chinese naive children chronic hepatitis B~     patients. Single group of child patients were enrolled, which include HBeAg positive and~     negative Chronic hepatitis B(CHB)group.~   "
94697|NCT02327663|"~     This study evaluates generic emtricitabine(FTC) in Chinese naive chronic hepatitis B~     patients. Patients were divided into 2 groups: HBeAg positive Chronic hepatitis B(CHB)group~     and HBeAg negative Chronic hepatitis B(CHB)group.~   "
94698|NCT02327650|"~     Generally, osteoarthris (OA) is considered as primarily cartilage disease. However, as we and~     others have previously reported, a portion of OA might be caused primarily by bone~     alterations. In this study, we prospectively and retrospectively show that the bone~     altertations may affect OA primarily in all of the joints.~      In addition, rheumatoid arthritis (RA) is a joint disease when immune system attacks~     synovium. Joint destruction occurrs continuously if suitable treatment is not performed. The~     etiology of RA is still largely unknown. As with OA, RA can be primarily damaged in bone,~     instead of cartilage. Here we prospectively and retrospectively show that the bone~     altertations may affect RA primarily in all of the joints.~   "
94699|NCT02327637|"~     Bed rest has been a commonly prescribed intervention for high risk pregnancies, despite the~     lack of data to support its benefits, and increasing evidence pointing to potential harms. In~     this study, the effects of bed rest compared to moderate activity will be on maternal mood~     and muscle strength will be evaluated in patients with preterm premature rupture of membranes~     (PPROM).~   "
94700|NCT02327624|"~     The principal hypothesis of this study is that two different maintenance regimens of~     ticagrelor are safe, tolerable and associated with significant inhibition of erythrocyte~     adenosine reuptake compared to clopidogrel in patients undergoing elective Percutaneous~     Coronary Intervention (PCI) for stable Coronary artery disease (CAD).~   "
94701|NCT02327611|"~     Postoperative renal failure is the most significant risk factor for early mortality after~     elective surgical repair of thoracoabdominal aortic aneurysms (TAAAs).~      To prevent damages related to kidney ischemia during aortic crossclamping and TAAA repair,~     the most recent guidelines recommend the use of cold crystalloid or blood perfusion. Since~     the most studied crystalloid solution is the Ringer's lactate solution, this can be~     considered the standard of care for evaluating the effectiveness of other substrates.~      An histidine-tryptophan-ketoglutarate enriched crystalloid solution named Custodiol (Dr.~     Franz Kohler Chemie GmbH, Bensheim, Germany) is currently used for organ preservation during~     transplantation and for cardioplegia during open-heart surgery in most EU countries. This~     solution may provide a better grade of renal protection to ischemic damage than the standard~     crystalloid solutions.~      A recent observational study published by our group suggested a lower incidence of~     postoperative renal kidney injury in patients undergoing open TAAA surgical repair using~     renal perfusion with Custodiol, as compared to those perfused with an enriched Ringer's~     lactate solution.~      Objective of this study is the confirmation of the promising findings about the effectiveness~     of renal perfusion with Custodiol during repair of TAAA compared with other crystalloid.~      The study will be a prospective, single-center, randomized, double-blind, controlled trial,~     investigating Acute Kidney Injury in patients undergoing TAAA open repair using Custodiol~     renal perfusion versus an enriched Ringer's lactate solution. It is expected to enroll adult~     patients undergoing elective TAAA open repair. Participants will be followed for the duration~     of hospital stay, an expected average of 2 weeks.~   "
94702|NCT02327585|"~     ADHD children have executive function (EF) impairments,so we randomize the children to the~     training or a waitlist to improve EF ,adding contingent reinforcement to ascertain whether EF~     deficits are amenable to the training in children with ADHD.~   "
94703|NCT02327572|"~     This research project aims to study this intriguing relationship between ageing and breast~     cancer biology, and more specifically the changes that occur within the tumor~     microenvironment with increasing age. Furthermore, it will focus on the link between these~     microenvironmental changes and organismal ageing (as measured by chronological age, geriatric~     evaluation of elderly patients, and circulating biomarkers of ageing), since it seems logical~     that age-related changes in the stromal part of a tumor (fibroblasts, immune cells,~     endothelial cells, fatty cells, …i.e. host cells) are due to the ageing process of the entire~     body. Most particularly, the amount and type of infiltrating immune cells might reflect the~     degree of immunosenescence of the host. More and more research points out the crucial role of~     the immune system in tumorigenesis and progression, and, at the same time, the immune system~     is one of the most affected components in the process of ageing. .~   "
94704|NCT02327559|"~     The purpose of this small randomized controlled trial (RCT) is to compare the impact of a~     brief (16 hour) 3rd trimester mindfulness-based childbirth education program, Mind in Labor~     (MIL): Working with Pain in Childbirth, with a standard care/treatment as usual (TAU)~     active control condition of standard hospital- and community-based childbirth education. The~     MIL group is expected to demonstrate a reduction in fear of labor (less pain catastrophizing~     and greater childbirth self-efficacy), less perceived pain in labor, less use of pain~     medication in labor, greater birth satisfaction, and better prenatal and postpartum~     psychological adjustment compared to the TAU group.~   "
94705|NCT02327546|"~     The primary purpose of this study is to assess the single-dose bioavailability of AKB-6548~     with ferrous sulfate relative to AKB-6548 in healthy volunteers.~   "
94706|NCT02327533|"~     In this study, the investigators evaluated molecular biomarkers which play a role in the~     development of generalized aggressive periodontitis (GAgP) using gingival tissue samples~     through omics-based whole-genome transcriptomic while using healthy individuals as background~     controls.~   "
94707|NCT02327520|"~     The authors retrieved in-patient medical data, including the expense, from the 2010 Thailand~     Nationwide Hospital Admission Database, which is part of the National Health Security Office~     (NHSO). The diagnosis of digestive diseases with any form of colitis listed in the causes,~     either as principal diagnosis or co-morbidity, coding by the ICD-10 was recorded. The~     inclusion criteria were: 1) diagnosis of enterocolitis due to Clostridium difficile~     (ICD10-A07); and 2) age of more than 18 years. If the data was incomplete, the case was~     excluded. The baseline characteristics, including age, sex, co-morbidity disease and history~     of endoscopy or surgery, were recorded. The burden of CDI was evaluated by length of hospital~     stay (LOS), mortality rate, and hospital charge.~   "
94708|NCT02327507|"~     Dental caries (tooth decay) is a disease with significant public health implications~     afflicting low-income children, with marked rural disparities in disease prevalence and~     treatment. More than 70% of 11th grade children in Crook, Deschutes and Jefferson counties~     have experienced tooth decay. Effective approaches to prevent decay include brushing with~     fluoridated toothpaste and professional dental care. Medicaid enrolled children are legally~     entitled to dental care under Early Periodic Screening, Diagnosis and Treatment (EPSDT), yet~     <50% had any care in 2010. Free distribution of toothpaste and toothbrushes combined with~     parental education can increase toothbrushing frequency and reducing tooth decay. However,~     many parents are confused about when to start, how much and often toothpaste should be used,~     and how to overcome behavioral difficulties in brushing toddlers' teeth or getting older~     children to brush their own. The investigators' objective is to implement and evaluate a~     community-wide toothpaste distribution campaign enhanced by telephone support for OHP~     children and adolescents and their families in Central Oregon~   "
94719|NCT02327351|"~     Treatment Study to assess of safety and efficiency of T cells receptor (TCR) alfa beta~     depleted graft for hematopoietic stem cell transplantation (HSCT) from haploidentical and~     unrelated donors in patients with primary immunodeficiency diseases~   "
94720|NCT02327338|"~     Objective- To see if the use of heat at home between physical therapy sessions results in~     better therapy outcomes in people with acute neck pain.~      Setting: Physical Therapy outpatient rehabilitation center Participants: 90 people with acute~     nonspecific neck pain broken into 4 groups. Intervention: All subjects will undergo 45~     minutes of therapy 2 times per week for 2 weeks. All subjects will accomplish 1 hour of~     therapeutic exercise at home on days when there is no therapy. Thirty of the subjects will~     use ThermaCare neck wraps before home exercise, 30 used Ibuprofen plus ThermaCare neck wraps~     before home exercise, 15 will use a sham heat wrap and an Ibuprofen placebo each day (1200 mg~     / day) and the last 15 will be controls with conventional physical therapy.~   "
94709|NCT02327494|"~     Anesthesia favouring deep/intense neuromuscular blockade during laparoscopy may restore~     hemodynamics. However, no studies has been performed comparing oxygenation parameters during~     laparoscopy in colorectal surgery in either moderate or intense neuromuscular blockade.~      The investigators aim to investigate whether the intense neuromuscular blockade produces a~     better oxygenation profile measured by the central venous oxygen saturation than the moderate~     neuromuscular blockade.~      This is a one centre, prospective clinical trial to compare oxygenation data at different~     stages of neuromuscular blockade in high-risk patients scheduled for colorectal surgery. Data~     recording will be blinded to the anesthesiologist in charge of the patient, who will manage~     patients by a determined protocol, based on stroke volume data to direct fluidotherapy. Data~     analyzer will be not be involved in the study design or in writing reports from the study.~     Inclusion criteria: Be a candidate to a colorectal surgical resection procedure and one of~     these conditions: ≥ 70 y.o, or respiratory co-morbidity, or cardiac co-morbidity or~     haemoglobin level < 11g/dl. The primary outcome is the absolute number of the central venous~     oxygen saturation, measured at the following points: basal, after tracheal intubation, before~     pneumoperitoneum or abdominal incision, after pneumoperitoneum or abdominal incision, 5 and~     10 minutes before administration of rocuronio to produce intense blockade, continuously~     during profound neuromuscular blockade until the end of surgery, before sugammadex~     administration, after sugammadex administration, after tracheal extubation, for the 24 hours~     post surgical. Data of the regional cerebral oxygen saturation will be measured at the same~     points.~      The investigators hypothesize that oxygenation data will be favourable by applying the~     intense neuromuscular blockade in comparison with moderate neuromuscular blockade. Also, the~     investigators hypothesize that oxygenation data obtained during the whole procedure including~     the first 24-hours post-surgery, measured by the regional cerebral oxygen saturation are~     comparable to data obtained by the central venous oxygen saturation. The investigators want~     to obtain information about influence in the outcome of producing profound neuromuscular~     blockade during laparoscopy colorectal by comparison of outcome data with matched historical~     control.~   "
94710|NCT02327481|"~     The purpose of this study is to explore the feasibility of 3D Laparoscopic Surgery for~     Gastric Cancer.~   "
94711|NCT02327455|"~     The specific aim of this clinical trial is to translate the investigators new 4DE (three~     sptial dimensions pluse time) stress echocardiographic method to patients with coronary~     artery disease referred for clinically indicated dobutamine stress/rest echo to evaluate the~     reproducibility of the technique in this clinical setting.~   "
94712|NCT02327442|"~     The purpose of this study is to assess the safety, biodistribution, dosimetric properties of~     the positron emission tomography (PET) radiopharmaceutical agent 68Ga-NOTA-NFB. To~     preliminarily evaluate its application in glioma diagnosis.~      To assess the application of 68Ga-NOTA-NFB PET/CT in the evaluation of the neoadjuvant~     chemotherapy in patients with breast cancer before and after the therapy.~   "
94713|NCT02327429|"~     In Canada, there is a fast-growing population with diabetes, and the majority of diabetes~     cases are type 2 diabetes (T2D). Diabetes and its complications, such as cardiovascular~     diseases, eye disease and foot disease, impair the quality of life and life expectancy.~      Chinese are the second largest visible minority in Canada. The diabetes incidence increased~     much more rapidly in the Canadian population of Chinese origin compared with that of European~     origin in past decades. Cultural factors are very likely to affect individual behaviour in~     diabetes treatment. Both international and Canadian diabetes organizations have recognized~     the importance of taking into account the cultural background and individual preferences in~     diabetes treatment.~      However, there lacks cultural relevant nutritional recommendations or guidelines for Chinese~     Canadians except some literally translated materials which may not be culturally relevant. In~     order to fill the gap, the investigators have developed a Chinese menu plan that includes~     commonly consumed Chinese dishes with nutrients breakdown and cooking tips to provide~     guidance for patients in their daily meal planning. This menu plan is a cultural translation~     of the Canadian nutritional guidelines, which is urgently needed among Chinese immigrants~     with T2D in Edmonton, according to our previous needs assessment.~      In this pilot test, the investigators will examine the feasibility and effectiveness of the~     Chinese menu plan. Twenty Chinese with T2D in Edmonton will be recruited to use the menu plan~     for 3 consecutive months and relevant indices of T2D will be tested as indicators of~     effectiveness. Feedback from participants will be obtained through one-on-one interviews and~     appropriate modifications will be made to the menu plan.~   "
94714|NCT02327416|"~     This study is a multi-center, randomized, prospective, open-label Phase III Clinical trial to~     assess the efficacy and safety of combination and sequential treatment with Y peginterferon~     Alfa-2b,entecavir and GMCSF in chronic hepatitis B patients nucleotides or nucleosides~     experienced. Patients were randomized to one of 3 groups to receive different antiviral~     treatment.~   "
94715|NCT02327403|"~     Background: Proteinuria develops in about 30% of kidney transplant recipients and is a strong~     predictor of graft loss. The amount of proteinuria has a direct correlation with the risk of~     graft failure. Novel therapies are urgently needed to reduce proteinuria and prevent graft~     loss in transplant recipients, since ACE inhibitors carry a number of limitations in the~     transplant setting, including significant reduction in renal function, anemia and~     hyperkalemia.~      Preliminary data: B7-1 is expressed at significant levels in about 10% of kidney allograft~     biopsies with predominance in patients with proteinuria.~      Hypothesis: We hypothesize that B7-1 targeting therapy may reduce proteinuria and improve~     graft survival in proteinuric transplant recipients that have B7-1 staining on allografts. In~     addition, the absence of CNI nephrotoxicity and the potential protective effect of Belatacept~     on DSA production may be of benefit in this subset of transplant patients.~      Objectives:~      Primary: Determine the effect of Belatacept conversion in reducing proteinuria by 25% at 12~     months in renal transplant recipients (≥1gram/d) that are either B7-1-positive or negative on~     kidney biopsy.~      Secondary: Assess the effect of Belatacept conversion in the percent change of renal function~     from baseline to 12 months; donor-specific anti-HLA antibodies presence and intensity (MFI);~     correlation of B7-1 positivity on immunofluorescence on biopsy with B7-1-expression in urine~     extracellular vesicles; adverse events; acute rejection episodes; blood pressure control; new~     onset diabetes; hyperlipidemia; graft survival; and patient survival.~   "
94716|NCT02327390|"~     This phase I trial studies the safety and best dose of ex-vivo activated lymph node~     lymphocytes (X-ACT) as well as how well the immune system responds to X-ACT treatment in~     participants with stage IIIC-IV melanoma. X-ACT treatment involves removing a participant's~     lymph node(s) close to a melanoma tumor. These lymph nodes contain special kind of cells~     (called T cells) which can be activated (getting the cells to start up certain responses in~     the immune system) outside of the body in an approved laboratory. The activated T cells are~     then injected back into the same participant using an i.v. to help the participant's immune~     system to target melanoma. The participant will undergo regular blood testing to determine~     whether the X-ACT treatment has resulted in changes to the immune system and also whether the~     T cells which were given back to the patient persist in the blood stream over time. In~     addition, the effect of the X-ACT treatment on the growth or shrinkage of the participant's~     melanoma will be measured.~   "
94721|NCT02327325|"~     Chronic low back pain (cLBP) is one of the most common and disabling conditions among US~     military Veterans. Although physical activity can improve cLBP outcomes, the majority of~     Veterans with cLBP are inactive. Therefore the VA is in need of effective programs that can~     help older Veterans with cLBP to increase their physical activity and improve associated~     outcomes. This is particularly relevant for older Veterans with cLBP who are at greater risk~     for functional limitations. The proposed project will be a pilot study of a telephone-based~     physical activity program or physical activity combined with cognitive behavioral pain~     management for older adult Veterans with cLBP. Older Veterans are of particular interest~     because prior studies of physical activity for cLBP have not addressed this vulnerable~     patient group. This study will also inform the VA about whether certain patients with cLBP,~     who have greater pain sensitivity, may benefit from other treatment to supplement a physical~     activity program.~   "
94722|NCT02327312|"~     To evaluate the safety and effectiveness of Trabecular Micro-Bypass stents (two stents per~     study eye) vs. laser trabeculoplasty, in subjects with open angle glaucoma~   "
94723|NCT02327299|"~     Iron deficiency is a highly prevalent nutrient deficiency which is a public health problem,~     especially in developing countries. There are several strategies to correct iron deficiency~     in populations: besides supplementation with tablets, one of the most sustainable and~     effective strategies on medium term has been iron fortification, the addition of iron to~     regularly consumed foods. In fortification, the chemical nature of the compound to be added~     plays an important role: depending on the compound sensory qualities of the fortified foods~     can vary as well as the iron absorption. Iron pyrophosphate (FePP) and ferrous sulfate~     (FeSO4) are two commonly used iron fortification compounds in foods such as rice, breakfast~     cereals, pasta, flour and others. We want to test the effect of addition a food stabilizer on~     the absorption of ferric pyrophosphate (FePP) and ferrous sulfate (FeSO4) when added to~     bouillon, as was recently suggested by in vitro experiments in the laboratory.~   "
94724|NCT02327286|"~     Randomized trial aiming to investigate the effectiveness of a lifestyle intervention program~     implemented within the first year after a pregnancy complicated by gestational diabetes~     (GDM), in delaying or preventing the development of type 2 diabetes.~   "
94725|NCT02327273|"~     The purpose of this study is to evaluate the safety profile, tolerability, Pharmacokinetics~     (PK) and Pharmacodynamics (PD) following single and multiple oral doses of BMS-963272 in~     healthy subjects.~   "
94726|NCT02327260|"~     This project will pilot test an intervention to increase participation rates in cardiac~     rehabilitation and medication adherence among patients following a cardiovascular event. The~     intervention will use an educational video shown during referral to cardiac rehabilitation~     (before hospital discharge), along with a brief, telephone-delivered counseling session to~     increase motivation to participate in cardiac rehabilitation and take all cardiac medications~     as prescribed (following hospital discharge). One hundred twenty patients who have~     experienced a cardiovascular event, and who are eligible for cardiac rehabilitation, will be~     recruited to participate in the study. Three groups of participants (40 each) will be formed:~     a control group that receives standard care, a first experimental group that sees the~     educational video and receives motivational counseling to attend cardiac rehabilitation, and~     a second experimental group that receives motivational counseling to adhere to their~     medications as prescribed. It is expected that the experimental group participants will~     differ from the control group participants in rates of participation in cardiac~     rehabilitation (experimental group #1) and medication adherence (experimental group #2). If~     successful, this intervention could be used in hospital settings to increase patients'~     adherence behaviors.~   "
94727|NCT02327247|"~     The study was conducted as an open-label, balanced, randomized, two-treatment, two-period,~     two-sequence, single-dose, crossover, bioequivalence study comparing Felodipine extended~     release tablets USP 10 mg (containing felodipine 10 mg) manufactured by OHM Laboratories,~     Inc., NJ, 08901 with PLENDIL® extended release tablets 10 mg (containing felodipine 10 mg)~     manufactured by Merck & Co. Inc. Whitehouse Station, NJ 08889 USA for AstraZeneca LP~     Wilmington, DE 19850 in healthy, adult, male, human subjects under fasting condition.~   "
94728|NCT02327234|"~     The study will assess airway responses in mild atopic asthmatics undergoing repeat allergen~     challenge testing and will investigate whether ibuprofen changes the response.~   "
94729|NCT02327221|"~     The investigational product, named Ovasave (Ova-Treg), is a cell-based therapy, consisting of~     an autologous antigen-specific regulatory type 1 T lymphocyte expanded population~     administered via the intravenous route as an infusion.~      The study is a multicenter, randomised, double-blinded, placebo-controlled, multi-dose and~     multi-injection study; followed with a 16-week phase with either the possibility for an~     open-label treatment part or a safety follow-up part with no injection.~      Then, the patients will be followed in an additional long-term safety follow-up, of maximum~     duration of 3 years from the first administration.~   "
94730|NCT02327208|"~     The objectives of this study are to: 1) determine effects of a prototype recovery food~     product providing supplemental energy on whole-body protein balance, skeletal muscle mass,~     and biomarkers of physiological status and strain during winter military training, and 2)~     determine the extent to which varying macronutrient composition (protein-based [PRO] versus~     carbohydrate-based [CHO]) of the food product modulates the physiological consequences to~     strenuous military training.~   "
94731|NCT02327195|"~     The purpose of this study is to assess whether methylphenidate affects time of emergence from~     isoflurane general anesthesia. Time to emergence was defined as the time from termination of~     isoflurane to extubation. After stopping isoflurane infusion, when the patient breaths~     spontaneously with adequate tidal volume and respiratory rates, the trachea will be extubated~     and the time will be recorded.~   "
94732|NCT02327182|"~     The objective of this study is to evaluate the safety and efficacy of 2 fixed dose of MT-4666~     administered once daily for 52 weeks with or without receiving a concomitant~     acetylcholinesterase inhibitors (AChEIs), in patients with mild to moderate Alzheimer's~     Disease (AD).~   "
94733|NCT02327169|"~     The primary purpose of this study is to determine the safety profile and the maximum~     tolerated doses (MTDs)/ potential recommended phase 2 doses (RP2Ds) of the combination~     treatments of MLN2480 + MLN0128, MLN2480 + alisertib, MLN2480 + paclitaxel, MLN2480 +~     cetuximab, and MLN2480 + irinotecan in participants with advanced nonhematologic~     malignancies.~   "
94735|NCT02327143|"~     The aim of this study is to compare how much of the study drug gets into the blood stream~     when it is given as a single oral dose and as an intravenous infusion (given directly into a~     vein via a small needle).~      The study will also provide information on how well the study drug is tolerated when given as~     a tablet in combination with giving it intravenously, and information on any changes in heart~     function.~      The study will last about 10 days. Screening is required within 28 days before study drug is~     given.~   "
94736|NCT02327130|"~     Carbon-12 and carbon-13 are naturally-abundant isotopes in exhaled breath carbon dioxide. The~     ratio of carbon-13 to carbon-12 in exhaled breath is known as the breath delta value (BDV).~     This study is seeking to determine if the breath delta value of critically ill adults is an~     early indicator of the onset of infection that may lead to sepsis.~   "
94737|NCT02327117|"~     Total Knee Arthroplasty (TKA) is a common orthopedic surgery usually leads to Bleeding. The~     null hypothesis of this study was that TA has no effect on post surgical bleeding in patients~     undergoes TKA.~   "
94738|NCT02327104|"~     The dependence on tobacco is a predictable leading cause of death. The treatment based on the~     cognitive-behavioral therapy, including relapse prevention, became standard for tobacco~     dependents; yet scientific advances are still needed. Accordingly, the Mindfulness-Based~     Relapse Prevention (MBRP) program, adjunct to treatment, has shown promising results. The~     purpose of this project is to evaluate the effectiveness of the program MBRP as an adjunct in~     the treatment of smoking cessation instituted by the Ministry of Health, through the~     Instituto Nacional do Câncer (INCA) in Brazil.There will be a randomized clinical trial, with~     a simple random allocation. 60 patients will participate in this study receiving treatment~     (INCA'S standard) randomized between two groups: the MBRP Group (EG), which will undergo~     eight sessions of MBRP; and the Control Group (CG) that will undergo eight sessions of the~     traditional model of Relapse Prevention.This study will be conducted at Ambulatory benchmark~     to smoking cessation treatment in the city of Juiz de Fora (Minas Gerais State- Brazil).~     Changes will be evaluated on several variables such as cessation of smoking, anxiety,~     depression, craving, positive and negative affects and will investigate the association of~     levels of mindfulness with smoking cessation. The data will be assessed at baseline (T0) and~     four other times: 1 (T1), 3 (T2), 6 (T3) and 12 months (T4) after the initiation of the~     study, besides being subjected to evaluations of regularly planned maintenance in the~     protocol of Ministry of Health. For data analysis there will be used Analysis of Variance~     with Repeated Measures and Longitudinal Logistic Regression, in order to evaluate the effect~     of two types of intervention on the evolution of comorbidities and abstinence of patients.~   "
94739|NCT02327091|"~     The age-related increase in falls is strongly associated with a decline in muscle strength by~     the mechanism of sarcopenia. There has been great interest in developing approaches to~     counteract the effects of sarcopenia, and thereby reduce the age-related decline in muscle~     mass with vitamin D that have muscular effect. However, a limited number of studies~     demonstrate a vitamin D analog (alfacalcidol) increase in lower body muscle strength in~     adults with vitamin D deficiency. A double-blinded randomized controlled trial was conducted~     in order to determine the effect of alfacalcidol on the upper-body muscle strength in~     Indonesian elderly women in age group of 60 or more who had low handgrip strength.~   "
94740|NCT02327078|"~     This is a Phase 1/2, open label study. Phase 1 consists of 2 parts. Part 1 is a~     dose-escalation assessment of the safety and tolerability of epacadostat administered with~     nivolumab in subjects with select advanced solid tumors and lymphomas. Part 2 will evaluate~     the safety and tolerability of epacadostat in combination with nivolumab and chemotherapy in~     subjects with squamous cell carcinoma of head and neck (SCCHN) and non-small cell lung cancer~     (NSCLC).~      Phase 2 will include expansion cohorts in 7 tumor types, including melanoma, NSCLC, SCCHN,~     colorectal cancer, ovarian cancer, glioblastoma and diffuse large B-cell lymphoma (DLBCL).~   "
94741|NCT02327065|"~     The purpose of this study is to compare the diagnosis accuracy of FNA and FNB biopsy on~     pancreatic, retroperitoneal, mediastinum and pelvic cavity solid occupying lesions.~   "
94742|NCT02327052|"~     One of the most challenging issues of chronic Chagas disease is to provide earlier detection~     of heart involvement. Two-dimensional speckle tracking (2-D ST) echocardiography, a new~     imaging modality with useful applications in several cardiac diseases, has been validated for~     subjects with myocardial infarction against cardiac magnetic resonance (CMR). Here the~     investigators hypothesize that the longitudinal global strain (LGS) has an incremental value~     to ejection fraction for predicting myocardial fibrosis in subjects with Chagas disease.~   "
94743|NCT02327039|"~     In Phase 2b/3 clinical trials, Dapagliflozin has been shown to raise HDL cholesterol levels~     by about 4 mg/dl (1 mmol/l), which is generally considered a clinically-meaningful change. As~     this HDL cholesterol increase is carried out with concomitant improvement in glucotoxicity~     and body weight reduction, it is possible that treatment with Dapagliflozin also improves HDL~     function. This is important because clinical, epidemiological and experimental studies~     indicate that HDL function may be more important than HDL cholesterol levels in determining~     the protective cardiovascular effects of HDL particles. In addition, knowing the effects of~     Dapagliflozin on HDL function can help interpreting the increase in HDL cholesterol levels~     observed in Dapagliflozin-treated patients. Finally, discovery of extra-glycemic effects of~     Dapagliflozin will shed new light on the potential benefits of therapy with Dapagliflozin and~     SGLT2i in general. So far, no study evaluated the effects of Dapagliflozin (or other SGLT2i)~     on HDL function.~      The investigators hypothesize that Dapagliflozin, in addition to raising HDL cholesterol~     levels, also increases HDL functionality, measured as reverse cholesterol transport and~     anti-oxidant capacity, in patients with T2DM~   "
94744|NCT02327026|"~     The aim of this study is to improve the management of patients in cardiac arrest, and this by~     comparing two initial airway management methods: Tracheal intubation and bag-valve-mask~     ventilation.~      The survival rate at 28-day with favorable neurological function will be compared in the~     tracheal intubation group versus the bag-valve-mask group~   "
94745|NCT02327013|"~     The purpose is to determine the effect of vortioxetine treatment on ADHD symptoms in adult~     patients with ADHD in a 12 weeks study.~   "
96071|NCT02309658|"~     The propose of this study is to determine if neoadjuvant chemotherapy followed by~     chemoradiation is safe and effective in locally advanced cervical cancer patients. Moreover,~     the study would determine if there is any association between hENT1 expression and response~     rate to gemcitabine.~   "
94746|NCT02327000|"~     The purpose of this clinical trial is to compare the pharmacokinetic characteristics of~     GLA5PR GLARS tablet 150mg and Lyrica Capsule 75mg.~      GLA5PR GLARS tablet 150mg is a New Formulation which is made by GL Pharm Tech.~      GLARS(Geometrically Long Absorption Regulated System) is New Solution to Sustained Absorption~     by Extending the Absorption Site.~      To overcome the shortcomings of the currently existing sustained release drug delivery~     technologies the investigators have recently developed a novel drug delivery system to enable~     a drug to be dissolved irrespective of the surrounding environment and further absorbed up to~     colon. The investigators coined this Geometrically Long Absorption Regulated System(GLARS).~   "
94747|NCT02326987|"~     The purpose of this clinical trial is to compare the pharmacokinetic characteristics of~     GLA5PR GLARS tablet 150mg and Lyrica Capsule 75mg.~      GLA5PR GLARS tablet 150mg is a New Formulation which is made by GL Pharm Tech.~      GLARS(Geometrically Long Absorption Regulated System) is New Solution to Sustained Absorption~     by Extending the Absorption Site.~      To overcome the shortcomings of the currently existing sustained release drug delivery~     technologies the investigators have recently developed a novel drug delivery system to enable~     a drug to be dissolved irrespective of the surrounding environment and further absorbed up to~     colon. The investigators coined this Geometrically Long Absorption Regulated System(GLARS).~   "
94748|NCT02326974|"~     This research study is studying a combination of drugs as a possible treatment for breast~     cancer that has tested positive for a protein called HER2.~      The names of the study interventions involved in this study are:~        -  Trastuzumab emtansine (also called T-DM1)~        -  Pertuzumab~   "
94749|NCT02326961|"~     The primary objective of this study is to evaluate the safety and feasibility of~     intraarticular injection of Celution prepared adipose-derived regenerative cells injected~     into knees of patients with chronic knee pain due to osteoarthritis.~   "
94750|NCT02326948|"~     This case-control study matched by age and sex was performed to evaluate the region specific~     risk factors for gallbladder cancer in Jeju island, Korea.~   "
94751|NCT02326935|"~     The intent of this clinical study is to answer the questions: 1) is the proposed treatment~     safe and 2) is treatment effective in improving the disease pathology of patients with~     Multiple Sclerosis and clinical outcomes.~   "
94752|NCT02326922|"~     Research hypothesis: Release of levonorgestrel from Metraplant-E levonorgestrel releasing~     intrauterine contraceptive device is inadequate to be used as a medical line of treatment of~     dysfunctional uterine bleeding.~      The investigators aim to evaluate the therapeutic effect of the intrauterine system~     (Metraplant-E) in the treatment of dysfunctional uterine bleeding.~   "
94753|NCT02326909|"~     The purpose of this study is to establish in vivo sensitivity and specificity of OCT in the~     diagnosis of Upper Urinary Tract Urothelial Carcinoma.~   "
94754|NCT02326896|"~     Risk factors for difficult intubation are well described in anesthesiology. But intubation in~     the intensive care unit (ICU) is a challenging issue, associated with severe life-threatening~     complications. Non-anesthesiologist trainees performing ICU intubation may not fully~     appreciate the potential difficulty and complications.~      Therefore in this retrospective analysis the MACOCHA score will be used to determine~     difficult intubation in the ICU and predict intubation failure.~   "
94755|NCT02326883|"~     This pragmatic clinical trial will evaluate the effectiveness of two population-based~     outreach programs for preventing suicide attempts among patients identified as at-risk. The~     study will be conducted at Kaiser Permanente (KP) Washington (the lead site) and at~     HealthPartners, KP Colorado and KP Northwest. Electronic health records will be used to~     identify outpatients aged 18 or older who respond to a routinely administered PHQ depression~     questionnaire by reporting thoughts of death or self-harm most of the days or nearly every~     day. This trial will be limited to patients receiving care from one of the four~     participating health systems. Eligible patients will be automatically assigned to continue in~     usual care (1/3) or to either of the two intervention programs (1/3 each). Those assigned to~     usual care will not be contacted at all by study staff and will continue to receive usual~     care from treating primary care and mental health providers. Both intervention programs~     involve outreach by Epic secure messaging (with optional telephone outreach for those not~     reading messages). The Care Management intervention includes routine outreach to assess~     ongoing risk of suicide attempt and care management to monitor and facilitate ongoing~     engagement in outpatient follow-up. The Care Manager will coordinate care with treatment by~     primary and behavioral health care providers using Epic Staff Messaging (or telephone~     contacts if necessary). The Skills Training intervention uses an online skills training~     program to support patients in developing and using self-management skills for emotion~     regulation and crisis management. A Coach will monitor each participant's use of the program~     and send periodic messages (using Epic secure messaging) to encourage and support use of the~     program and practice of program skills. Each intervention continues for up to one year. In~     all three groups (Usual Care, Care Management, and Skills Training) virtual data warehouse~     data will be used to identify likely suicide attempts over 18 months following randomization.~     Analyses will compare risk of suicide attempt among all those randomized, regardless of~     response to the initial invitation or level of participation in the intervention programs.~     Comparison of all those randomized is the only scientifically valid method for assessing the~     overall impact of either program on population-level risk of suicide attempt.~   "
94756|NCT02326870|"~     The main objectives of this study are to evaluate the performance and ease of use of the~     Follow me mode of the AutoLap system during general and gynecological laparoscopic~     procedures.~   "
94757|NCT02326857|"~     Background:~      - Researchers want to learn more about breast cancer in Latin American women. They also want~     to learn how and why women respond differently to standard treatment. Tissue and blood~     samples from women with breast cancer are needed to study this disease in order to find new~     ways to prevent, diagnose, and treat it.~      Objective:~      - To learn more about the biology and genetics of breast cancer in Latin American women.~      Eligibility:~      - Latin American women age 18 and older of all ethnic backgrounds who have clinical stage II~     or III breast cancer. They must still be active and able to self-care.~      Design:~        -  Participants are only agreeing to have extra tissue or blood samples collected. They are~          also letting tissue left over from surgery be used for research. No procedures outside~          of standard care will be done.~        -  Participants may have a medical history, physical exam, and blood tests. They may have a~          pregnancy test. They may have an ultrasound, mammogram, and other scans. They may have~          an intravenous needle placed in an arm vein.~        -  Participants may have a core biopsy. For this, a needle is inserted into the breast. A~          piece of tissue is extracted.~        -  Participants who have chemotherapy may have blood taken after treatment/before surgery.~          Tissue may also be collected.~        -  Participants will complete a questionnaire. It will ask about their social and economic~          background. It will ask about their family history of cancer. It will also ask about~          access to diagnosis and treatment of breast cancer.~        -  Participants may be followed for up to 5 years.~   "
96072|NCT02309645|"~     The purpose of this study is to evaluate the safety and efficacy of EVICEL® when used for~     suture-line sealing in dura-mater closure in elective or urgent paediatric cranial~     neurosurgery to provide intraoperative watertight closure.~   "
94758|NCT02326844|"~     Background:~      - The new drug BMN 673 (talazoparib) has been shown to fight tumor cells in animals and some~     people. It is a poly (ADP-ribose) polymerase (PARP) inhibitor. It works on tumor cell~     deoxyribonucleic acid (DNA) damage repair process. Researchers want to see if BMN 673 shrinks~     cancer again in women with ovarian cancer and whose cancer initially got shrunk but grew back~     on the first PARP inhibitor.~      Objective:~      - To study BMN 673 (talazoparib) in people with ovarian cancer born with a breast cancer~     (BRCA) mutation and whose cancer got shrunk but became worse after they took a similar drug.~      Eligibility:~        -  Women at least 18 years old:~        -  with recurrent and/or metastatic germline breast cancer mutation (gBRCAm)-associated~          ovarian cancer AND~        -  whose disease is growing after already being treated with PARP inhibitors AND~        -  with no other treatment(s) in between the first PARP inhibitors and a screening visit.~      Design:~        -  Participants will be screened with medical history, physical exam, and heart and blood~          tests.~        -  Participants will take the study drug by mouth once daily. They will take the drug in~          28-day cycles.~        -  They will keep a diary of doses and any side effects.~        -  Participants will have 4 study visits in cycle 1, then 1 visit every cycle. Visits may~          include:~        -  Blood tests~        -  Physical exam~        -  Computed tomography (CT) or magnetic resonance imaging (MRI) scans. Participants will~          lie in a machine that takes pictures of their body.~        -  Ultrasound~        -  Participants will have a biopsy before starting the study drug. A small piece of tumor~          tissue will be removed by needle, guided by a scan. They may have two more biopsies~          later.~        -  Participants will be followed for 30 days after taking the last dose of study drug. A~          physical exam, blood tests, and CT or other scans will be done.~        -  Participants will have follow-up calls to ask about any side effects.~   "
94759|NCT02326818|"~     Background:~      - It is hard for people with arm spasticity and focal hand dystonia to control their arm and~     hand muscles. They are often treated with botulinum toxin (BoNT) injections. Electromyography~     with electrical stimulation (e-stim) and ultrasound are used to find muscles for BoNT~     injection. Researchers want to learn which method is faster and more comfortable.~      Objective:~      - To compare 2 ways of finding muscles for BoNT injection for the treatment of focal hand~     dystonia and upper limb spasticity.~      Eligibility:~      - Adults 18 and older with focal hand dystonia or arm spasticity who have been getting~     onabotulinumtoxin-A injections in protocol 85-N-0195.~      Design:~        -  Participants will be screened with medical history and physical exam.~        -  Participants will push or pull on a device that measures arm strength. They will have a~          neurologic exam. Women will have a pregnancy test.~        -  Participants will have a BoNT injection using either e-stim or ultrasound.~        -  For e-stim, sticky pads will be placed on the arm. A needle will be placed in the~          muscle. A small electric shock will be given through the needle. Then the injection will~          be given.~        -  For ultrasound, a probe will be moved across the skin. A screen will show an image of~          the muscles. Then the injection will be given.~        -  Participants will have a second injection 3 months later. They will have the method that~          was not used for their first injection.~        -  After each session, participants will rate their experience.~        -  Participants will have follow-up visits 1 month after each injection. They will be~          examined and asked about their response to treatment. Arm strength will be measured.~   "
94760|NCT02326805|"~     This randomized phase II trial studies how well PROSTVAC (prostate-specific antigen~     [PSA]-TRICOM) works in preventing disease progression in patients with prostate cancer~     undergoing active surveillance. Vaccines made from a person's tumor cells may help the body~     build an effective immune response to kill tumor cells that express PSA.~   "
94761|NCT02326792|"~     The fatigue of the trunk extensor muscles is often reported in people with the chronic low~     back pain (LBP). Evidences have showed that the strengthening muscular by the training of the~     lumbar spinal muscles is efficient to decrease the pain and disability symptoms of patients~     with the chronic LBP. Also, some studies have reported improve of the strength and endurance~     of the back muscles from of this type of training muscular. However, the exercise~     prescription for the trunk extensor muscles during the training is still not clear in the~     literature. In fact, no study has showed any differences between one and three sets of~     specific lumbar exercise with regard to better prescription of training in healthy subjects~     (e.g; preventive action) as well as in LBP subjects (e.g; intervention action).~   "
94762|NCT02326779|"~     The aim of this study is to evaluate the survival benefit of low-dose aspirin use for stage~     II-III esophageal cancer patients.~   "
94763|NCT02326766|"~     This study evaluated effects of red ginseng consumption on blood pressure (BP) and fasting~     plasma metabolomes.~   "
94764|NCT02326753|"~     The purpose of this study is to assess the adequacy of mask ventilation with the different~     sized-oropharyngeal airway.~   "
94765|NCT02326740|"~     The study will evaluate the efficacy and safety of gevokizumab in treating active ulcers of~     pyoderma gangrenosum (PG).~   "
94766|NCT02326727|"~     Regional anesthesia may decrease the release of endogenous opioids, increase Natural Killer~     cell (NK) function and decrease development of metastasis. The recent analysis of the Cancer~     Registry has noted an improved 5-year survival in patients who received epidural analgesia~     during surgery for colorectal carcinoma.~   "
94767|NCT02326714|"~     The purpose of this trial is to investigate the effect and safety of auricular acupressure on~     adolescent and young women with PCOS. Subjects will be randomly assigned in to two arms:~     Auricular acupressure arm and placebo auricular acupressure, both arms will be treated for~     three months. Body mass index, oral glucose tolerance test, hormonal profile and metabolic~     profile will be determined.~   "
94768|NCT02326701|"~     Echocardiographic assessment of right ventricular function is an important diagnostic tool,~     and is a challenge due to the unique structure and anatomy of the right ventricle. Lately a~     new technique has been developed and used for evaluating both the left and the right~     ventricle function. This technique, called two dimensional (2D) speckle tracking, is based on~     detecting speckles in the myocardial tissue and using them as acoustic markers. The movement~     of these speckles represents the movement of the tissue, and allows us to evaluate its~     function, contraction and relaxation, this by calculating the strain rate, which is the speed~     of the speckles, and the strain, which is the distance between them.~      In the last few years this technique has been used to evaluate the systolic function of the~     right ventricle in several pathological conditions, such as pulmonary hypertension, pulmonary~     embolism and amyloidosis. Nonetheless, so far there has been little data on the normal RV~     strain and strain rate values.~      In this study the investigators aim to validate two dimensional (2D) speckle tracking~     measurements of the RV function by comparing them to strain measurements by cardiac MRI. Each~     patient performing cardiac MRI for any indication will perform an echocardiography~     examination in addition, and strain analysis performed on the cardiac MRI will be compared~     with two dimensional speckle tracking analysis performed on the echocardiography.~   "
96312|NCT02306512|"~     The purpose of this study is to determine if immunofluorescence (IF) can effectively identify~     features of malignant melanoma in situ, on sun-damaged skin, in the setting of Mohs~     Micrographic Surgery.~   "
94770|NCT02326675|"~     Oral mucositis is a common complication of cancer therapy. Mucositis results from damage to~     the mucosal epithelium after delivery of chemotherapy or radiation treatments designed to~     treat the cancer. A number of treatment factors have been shown to influence the incidence~     and severity of mucositis, including chemotherapy type and dosage. High-dose chemotherapy~     before stem cell transplantation can cause severe oral mucositis and is often the side effect~     that patients find the most difficult to endure. Cryotherapy, keeping ice chips in the mouth~     during chemotherapy infusion, has been shown to prevent or alleviate mucositis caused by~     high-dose melphalan alone or given in combinations used in pre-transplant conditioning. One~     other drug notorious for causing severe mucositis is etoposide (VP-16). The specific aims of~     the study are: 1) to assess tolerability of cryotherapy given during chemotherapy~     administration; 2) to determine the efficacy of cryotherapy in reducing etoposide-induced~     mucositis.~   "
94771|NCT02326662|"~     This research investigates the use of autologous neural stem cells in patients with complete~     traumatic spinal cord injury.~   "
94772|NCT02326649|"~     This study will test the capability of a non-invasive instrument (the PhysioFlow impedance~     cardiography instrument) to measure cardiac output in patients with congenital heart disease~     (CHD). This instrument works by placing electrodes on the skin of a patient and measuring~     electrical impedance through the chest, which is proportional to blood volume and blood flow~     at any given time. The instrument has been validated in patients with structurally normal~     hearts, but in the only two studies using it for patients with CHD, it was deemed too~     inaccurate for clinical use. The manufacturer of the device would require access to data on~     the patients in order to improve its accuracy, and that has not been feasible thus far. This~     study would begin by comparing cardiac output based on the PhysioFlow monitor to standard~     techniques, then after possible changes to the instrument to enhance accuracy, would test the~     instrument again in the same way.~   "
94773|NCT02326636|"~     The purpose of this research is to investigate the efficacy of transplanting screened donor~     fecal material in treating patients with recurrent Clostridium difficile infection.~     Participants with refractory Clostridium difficile infection will be given healthy donor~     stool administered by colonoscopy or enema and their response will be evaluated by symptom~     questionnaire and stool testing for Clostridium difficile at 4 weeks after the treatment.~   "
94774|NCT02326623|"~     Many medical procedures aimed at helping children can cause them pain and distress. If~     children have certain levels of pain or distress, it can have long lasting negative effects.~     The emergency department can be a very stressful place for children and their parents. There~     are also many procedures that children may have in the emergency department that can cause~     pain and distress. These include procedures such as needle pokes, stitches, or setting a~     broken bone. Two common methods of managing a child's pain in the emergency department are~     drugs and distraction. Drugs are not always practical and may come with unwanted side~     effects. Distraction is often used by parents or health professionals to help children deal~     with pain and stress. Distraction can lower the child's pain and distress by moving their~     attention from the painful experience, for example a needle poke, to a more positive feeling~     such as watching a movie, playing a game, or listening to music. This study will test if~     iPads are useful to help lower pain and distress for children (ages 6 to 11 years) who are~     visiting an emergency department and need an intravenous line put in. The results from this~     study could be important for many children receiving medical care, as distraction is safe and~     the use of iPads is enjoyable for many children.~   "
94775|NCT02326610|"~     SGA Infants who do not show a developmental catch-up growth within the first 6 months of life~     fall in the category of SGA children shown to have defects in the GH/IGF-I axis, resulting in~     partial hGH/IGF-I deficiency.~      Up to 1/4 of children born SGA have neurodevelopmental deficits. The partial hGH/IGF-I~     deficiency in SGA children can be the major or contributory cause of to their~     neurodevelopmental deficits~      To assess the effect of early growth hormone treatment given to symmetrical small for~     gestational age (SGA) infants not demonstrating catch-up growth on neurodevelopment and~     growth between birth and 6-12 months.~      The study is an innovative research not previously performed for improving neurodevelopmental~     outcome of SGA infants. As this is the first study of its kind, the safety of use of GH has~     not been reported, however based on multiple studies assessing use of GH in infants and young~     children, it is reasonable to similarly expect no short and long-term adverse effects.~      The study will take place at the Tel Aviv Medical Center only.~   "
94776|NCT02326597|"~     Sickle cell disease (SCD) is an inherited disorder with chronic multi-system manifestations~     affecting 100,000 individuals in the US, largely of minority origin and associated with~     substantial morbidity, premature mortality, individual suffering, healthcare costs and loss~     of productivity. Disease modifying treatments such as Hydroxyurea, chronic blood transfusion~     and curative bone marrow transplantation are offered to patients based on physician~     preference and current practice informed by clinical trials. Decision aids are tools that~     could help translate evidence from these sources into practice by helping clinicians involve~     patients in making deliberate choices based on accessible information about the options~     available and their outcomes and to help them make decisions based on their values and~     preferences.~      The overarching goal of this project is to develop and implement a web based decision aid~     individualized to patient characteristics to help patients with SCD achieve more accurate~     perception of risks and benefits of treatment options and make decisions in congruence with~     their values and preferences.~      The investigators will conduct needs assessment interviews as indicated by the data for~     saturation and validation of findings. The investigators will conduct beta testing of the~     web-based decision aid to clarify development and validate findings. The investigators will~     use a randomized controlled trial of the effectiveness of a web-based decision aid to give~     patients accurate information about risks and benefits of therapies and enable them to make~     decisions based on their individual values and preferences.~      To provide accurate information to patients and caregivers about the risks and benefits of~     various treatments for sickle cell disease and to enable them to make informed and involved~     therapeutic decisions based on their values, preferences and stated goals.~   "
94777|NCT02326584|"~     This study will examine the safety profile of vadastuximab talirine (SGN-CD33A) by itself~     (monotherapy) or in combination with other standard treatments. The main purpose of this~     study is to find the best dose and schedule for SGN-CD33A when given in combination with~     standard induction treatment, in combination with standard consolidation treatment, or by~     itself for maintenance treatment. This will be determined by observing the dose-limiting~     toxicities (the side effects that prevent further increases in dose) of SGN-CD33A. In~     addition, the pharmacokinetic profile and anti-leukemic activity of the study treatment will~     be assessed.~   "
94855|NCT02325557|"~     A Phase 1/2 multicenter, dose determining, open-label study of ADXS31-142 monotherapy and a~     combination of ADXS31-142 with Pembrolizumab (MK-3475) in patients with metastatic~     castration-resistant prostate cancer. Part A will be dose-determining of ADXS31-142~     monotherapy. Part B will be dose-determining of ADXS31-142 and Pembrolizumad (MK-3475) in~     combination. Part B expansion will treat additional patients with the recommended dose from~     Part B.~   "
94778|NCT02326571|"~     Spontaneous intracerebral bleeding also known as spontaneous intracerebral hemorrhage (sICH)~     constitute 10-15 % of all apoplexies. The Prognosis is considerably worse than it is for the~     larger population of patients suffering from cerebral thrombosis. Development of brain edema~     seemingly contributes to the disadvantageous prognosis. However, the mechanisms behind is~     only understood fragmentarily.~      By using multimodal neuro monitoring, the investigators seek to investigate~     electrophysiological and metabolic processes, which seem to accompany the formation of edema~     and clinical deterioration in patients suffering from sICH.~   "
94779|NCT02326558|"~     The purpose of this study is to evaluate the feasibility, safety and efficiency of zero~     ischemia laparoscopic microwave ablation-assisted enucleation in comparison with conventional~     laparoscopic partial nephrectomy in the treatment of T1a renal cell carcinoma.~   "
94780|NCT02326545|"~     Anxiety is the most prevalent form of children's mental health problems and demand far~     exceeds treatment availability. Even when children do have access to care, evidence-based~     treatments such as cognitive-behavioural therapy have several limitations: they are largely~     didactic, leaving children unmotivated and disengaged; children get little practice in using~     the skills they are taught, creating a large gap between their knowledge and their everyday~     behaviour and therapy is costly, often prohibitive for the children that most need it.~     Therapeutic video games can address each of these gaps: they are engaging contexts through~     which children practice skills (rather than memorize lessons), and they cost substantially~     less than conventional approaches. The proposed research will test the effectiveness of~     MindLight, an innovative video game that targets childhood anxiety problems. MindLight~     incorporates several evidence-based strategies including relaxation and exposure techniques,~     attention bias modification methods, and neurofeedback mechanics that together produce an~     immersive game world through which children learn to manage and overcome anxiety symptoms.~     Two randomized controlled studies with 8-16 year old children are proposed to test the~     effectiveness of MindLight in reducing anxiety: the first is a prevention study aimed at~     children at risk for developing serious anxiety problems and the second is a clinical trial~     aimed at decreasing symptoms in anxiety-disordered children. Children randomly assigned to~     the intervention group will play MindLight for 5 hours over 2-3 weeks; control participants~     in the prevention sample will play a commercial video game with a similar theme for the same~     amount of time whereas control participants in the clinical sample will use an online~     cognitive behavioural therapy (CBT) program. Both studies will assess children's anxiety~     levels before the intervention, just after, and at a 3-month follow-up. Moderators (e.g.,~     comorbidities) and mediators (e.g., attention biases) will be assessed to identify potential~     mechanisms of change associated with successful intervention effects.~   "
94781|NCT02326532|"~     The overall goal of this proposal is to address barriers to the use of patient reported~     outcome (PRO) data in the Dept. of Veterans Affairs (VA) health care system.~   "
94782|NCT02326519|"~     Routine data collection will be conducted during normal sinus rhythm and AV synchronous~     pacing for approximately 20 minutes. The data collected will then be processed and the P, R~     and T wave amplitudes will be measured.~   "
94783|NCT02326506|"~     Veno-arterial extracorporeal life support (VA-ELS) is used to support patients with acute~     cardiac failure. In that context, sufficient drainable venous volume is crucial for reliable~     and adequate support. To date, no reliable measurement method exists to monitor drainable~     volume adequately. Furthermore, it is still unresolved how to diagnose adequate cardiac~     recovery.~      Previous (pre)clinical studies showed that the calculation of the dynamic filling index may~     provide a valuable parameter to monitor the drainable volume in patients supported by VAELS.~     In addition, a case report showed that measurement of the dynamic filling index could~     successfully be used to estimate cardiac recovery in a single patient supported by VA-ELS in~     the ICU.~      This study will assess the dynamic filling index as a representation for drainable volume and~     cardiac recovery using standard recorded perfusion data in patients supported by VA-ELS~   "
94784|NCT02326493|"~     Approximately one third of patients treated with cardiac resynchronization therapy (CRT) do~     not derive any clinical benefit. CRT response can be improved by tailoring LV lead placement~     and programming of atrio-ventricular (AV) and inter-ventricular (VV) stimulation intervals to~     the individual patient. However, the best strategy to optimize lead positioning and device~     programming still remains to be established. Earlier work in our research group suggests that~     the vector cardiogram (VCG) can be used to determine the optimal LV lead position and AV- and~     VV-intervals, and pilot studies showed the feasibility to derive a VCG-like signal (D-VCG)~     from the implanted pacing electrodes. Other studies have suggested that the best position for~     the LV electrode is the region of latest electrical activation. The region of latest~     electrical activation can be identified by measuring the electrical delay on the LV lead~     (LVLED) during implantation. The objective of this study is to investigate whether D-VCG can~     be used to determine the optimal AV- and VV-interval and whether VCG and LVLED can be used to~     determine the optimal LV lead position.~   "
94785|NCT02326480|"~     Identify news genetic causes of different type of obesity (syndromic, familial or isolated~     obesity) by highlighting new mutations or new implied genes~   "
94786|NCT02326467|"~     Literature provides overwhelming evidence supporting the use of chlorhexidine gluconate (CHG)~     a rapid onset, broad spectrum, topical antiseptic for reducing healthcare-associated~     infections (HAIs). CHG is believed to be superior to other forms of antiseptics because, when~     it is applied to the skin surface, it leaves a lasting residue on the skin. CHG has been~     shown to be well tolerated in patients 2 months of age and older. However there is limited~     evidence to support the use of topically applied CHG in infants less than 2 months of age~     because of potential safety concerns in this population. The purpose of this study will be to~     describe the safety of bi-weekly CHG baths in a sample of Newborn Intensive Care Unit (NICU)~     and pediatric Cardiac Intensive Care Unit (CICU) patients by measuring the incidence of skin~     problems and CHG blood levels.~   "
94787|NCT02326454|"~     This study investigates the safety and efficacy of a photosensitive drug (talaporfin sodium)~     activated by an intraurethrally placed drug-activating device. Two different light doses will~     be tested against placebo groups in this 4-arm study.~   "
94788|NCT02326441|"~     The purpose of this study is to determine the safety and tolerability of the study drug~     KX2-361 and to determine how much of the study drug enters the bloodstream, in patients with~     advanced malignancies that have not responded to conventional therapies.~   "
94838|NCT02325791|"~     The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and~     immunogenicity of REGN2222 in infants born no more than 35 wGA (weeks gestational age), who~     are no more than 6 months of age at the time of enrollment in their respective geographic~     location. In order to optimize the potential benefit in this vulnerable population, we will~     conduct this study during the RSV season using dosing regimens that are expected to be~     effective.~   "
94856|NCT02325544|"~     The study will test the hypothesis that Cognitive Behavioural Therapy plus Standardised~     Medical Care (SMC) will have greater clinical and cost effectiveness than SMC alone in~     treating adult patients with dissociative seizures which had not initially ceased after~     diagnosis.~      About 12-20% of patients who attend neurology or specialist epilepsy clinics because of~     seizures do not in fact have epilepsy. Most of these people have what are referred to as~     dissociative (non-epileptic) seizures (DS). This means that they have episodes that resemble~     epileptic seizures but which have no medical reason for their occurrence and instead are due~     to psychological factors. In younger adults DS are about four times more common in women than~     men. A high percentage of these people will have other psychological or psychiatric problems~     and may have other medically unexplained symptoms. It is generally thought that people with~     DS will benefit from psychological treatments. However, studies on this have been small or~     have not compared the psychological therapy with the treatment people normally receive~     (standardised medical care). There is some evidence that cognitive behavioural therapy (CBT),~     which is a widely accepted talking therapy that focuses on the person's thoughts, emotions~     and behaviour, as well as considering the physical reactions and sensations that may occur in~     people's bodies, may lead to a reduction in how often people have DS. The investigators have~     previously developed a CBT package for people with DS. In a relatively small study by our~     group, published in 2010, people receiving CBT overall showed greater reduction in how often~     they had their DS. The investigators are now conducting a larger study, across several~     different hospitals, to obtain more definite results about the effectiveness of our CBT~     approach for DS.~      The investigators aim to invite ~ 500 adult patients with DS (but without current active~     epilepsy), who have been given their diagnosis by a neurologist or specialist in epilepsy, to~     take part in their study. Up to 698 might be invited if insufficient patients are progressing~     to the RCT.~      The investigators will collect initial information about these people and ask them to keep a~     record of how often they have their DS following diagnosis. Three months after the diagnosis,~     those who have agreed to take part in the study will be seen by a psychiatrist, who will~     undertake a psychiatric assessment and ask them about factors which may have led to the~     development of their DS. Patients who have continued to have DS in the previous 8 weeks and~     who meet other eligibility criteria and are willing to take part in the trial, will be~     randomly allocated to standardised medical care or CBT (plus standardised medical care) as~     further treatment for their seizures. These people will be asked to continue to complete~     seizure diaries and questionnaires, provide regular seizure frequency data following receipt~     of DS diagnosis and will need to be willing to attend weekly/fortnightly sessions if~     allocated to CBT. The investigators initially aim to randomise 298 people (149 to each study~     arm) although now allow for up to 356 to account for loss to follow-up.~   "
94789|NCT02326428|"~     Ischemic stroke, i.e. irreversible damage of a part of the patient's brain, is caused by the~     formation of blood clot in the major vessel which gives blood supply to a certain part of the~     brain. At early time, within the first 4,5 hours, the conventional treatment is to try to~     dissolve this blood clot with a medication (thrombolytic drug) which is administered to the~     blood through the needle in the vein. If the clot still remains there, additional treatment~     is possible - going directly to the clot via artery and taking it out with a special device.~     Patients may be included even if they are not treated with intravenous thrombolysis because~     of contraindication or other reasons. The purpose of the present study is to evaluate the~     benefit and safety efficacy of thrombectomy and standard stroke care in clinical routine~     treatment of acute occlusive stroke compared to standard stroke care only.~   "
94790|NCT02326415|"~     The aim of this study is to reduce the postoperative hospital stay, without increasing~     morbidity and mortality postoperative, expressed in terms of rate of complications and~     readmissions.~   "
94791|NCT02326402|"~     This study is intended to be a multicenter, prospective observation registry. By collecting~     prospective descriptive data, provide insight into disease defining characteristics resulting~     in the clinical decision to use TandemHeart for mechanical support and enhance knowledge of~     best practice regarding clinical management, weaning and removal/exit strategies.~   "
94792|NCT02326389|"~     The purpose of this study is to evaluate the potential benefits of combining cognitive~     remediation and exercise in improving cognitive functioning and response to psychiatric~     rehabilitation.~   "
94793|NCT02326376|"~     A non-interventional, post authorization safety study to evaluate the safety of Kineret in~     the treatment of Cryopyrin Associated Periodic Syndromes (CAPS) in routine clinical care with~     regard to serious infections, malignancies, injection site reactions, allergic reactions and~     medication errors, including re-use of syringe.~   "
94794|NCT02326363|"~     This study will provide important information concerning the used of mindfulness-based~     relapse prevention (MBRP) as a continuing care strategy for Veterans who have completed~     primary treatment for a SUD. Most research is focused on the acute care of SUDs, but the risk~     of relapse to substance use is highest during the period immediately following treatment and~     attention to continuing care is critical. If this trial demonstrates that MBRP promotes~     sustained abstinence and improved functional outcomes, this will provide a valuable treatment~     to facilitate rehabilitation and recovery for Veterans with SUDs.~   "
94795|NCT02326350|"~     Acute Respiratory Distress Syndrome (ARDS) causes the lungs to fail due to the collection of~     fluid in the lungs (pulmonary oedema). ARDS is common in severely ill patients in Intensive~     Care Units and is associated with a high mortality and a high morbidity in those who survive.~     There is a large economic burden with direct healthcare costs, but also indirectly due to the~     impact on the carer and patient through their inability to return to full time employment.~     There is little evidence for effective drug (pharmacological) treatment for ARDS. Blood cells~     called platelets have increasingly been recognized to play a key role in the development of~     ARDS. There is increasing information that aspirin, a drug which is widely used to treat~     heart disease, might be important in treating ARDS. We plan to test if aspirin will help in~     the treatment of ARDS. To do this we will divide patients suffering from ARDS into two~     groups, one of which will get aspirin and the other a harmless dummy (or placebo) tablet who~     will then be followed up to determine if lung function improves. If effective this may lead~     to further research to determine if aspirin is effective in patients with ARDS. This project~     will also provide new information about mechanisms in the development of ARDS leading,~     potentially, to other new treatments.~   "
94796|NCT02326337|"~     The purpose of this study is to evaluate the efficacy, safety and economical benefits of~     Cyclical Pressure Topical Wound Oxygen (TWO2) Therapy in the treatment of chronic diabetic~     foot ulcers. Subjects will wear a standardized off-loading device and use advanced moist~     wound therapy (AMWT) dressings. Following a 2 week run-in period with the standardized care~     and after meeting all the eligibility criteria, half the subjects will use the TWO2 device,~     while the other half will use a sham device.~   "
94797|NCT02326324|"~     This study aims to investigate the diagnostic and prognostic utility of cardiovascular~     magnetic resonance (CMR) imaging in a large cohort of unselected patients who are undergoing~     CMR scanning for clinical indications (i.e. suspected/confirmed cardiovascular disease). CMR~     indices will be related to the presence and severity of cardiovascular disease and other~     markers of cardiovascular and health status.~   "
94798|NCT02326311|"~     In this phase III clinical randomized study, fixed intermittent administration (one month~     ON/one month OFF) of TKIs (control arm), will be compared with progressive intermittent~     administration (one month ON/one month OFF for the 1st year; one month ON/two months OFF for~     the 2nd year; one month ON/three months OFF for the 3rd year) (experimental arm). Imatinib~     (Glivec), or Nilotinib (Tasigna), or Dasatinib (Sprycel) will be given intermittently at the~     same daily dose that was given daily at the time of the enrollment . Chronic phase Ph+ CML~     patients in stable major molecular response (MR3.0 or MR4.0) after ≥2 years of standard~     treatment with IM, NIL, or DAS will be randomized 1:1 to receive fixed INTERIM or~     progressive INTERIM. Randomization will be stratified by type of TKI (IM, NIL, or DAS,) and~     by depth of molecular response (MR3.0or MR4.0). The study is aimed to evaluate if a~     progressive increase of intermittent treatment discontinuation until 3 months is able to~     improve QoL outcomes with respect to fixed intermittent administration of TKIs (control~     arm) and to maintain MR3.0 / MR4.0 molecular response. Patients' self reported EORTC QLQ-C30~     outcome measure will be assessed throughout the three years follow up period. The QoL results~     in this trial will be presented in accordance with high methodological quality criteria for~     documenting patient-reported outcomes (PRO) data in RCTs, including the CONSORT PRO~     recommendations. Furthermore, the study could give additional clinical and biological~     information to optimize TKIs therapy in elderly.~   "
94799|NCT02326298|"~     The purpose of this study is to investigate the efficacy and safety of two dose levels of~     certolizumab pegol in adults with moderate to severe chronic plaque psoriasis when~     administered every 2 weeks.~   "
94839|NCT02325778|"~     This study is designed to determine if CTI prior to CPVA/PVI/Linear Lesions/Fractionation~     results in reduced left atrial ablation lesion sets prior to restoration of sinus rhythm in~     patients with long standing persistent atrial fibrillation in the absence of antiarrhythmic~     drug therapy compared to CTI after CPVA/PVI/Linear Lesions/Fractionation.~   "
94800|NCT02326285|"~     This study is designed as a single arm, un-controlled, open-label, multi-center hypothesis~     generating two-stage phase II trial. It is based on the assumption that the proposed~     treatment scheme doubles the rate of pathologic complete remission in Mutated epidermal~     growth factor receptor (EGFRmt) + NSCLC patients compared to historical control data from~     standard treatments.~      Patients with NSCLC and activating EGFR mutation in stages II, IIIA and IIIB eligible for~     induction therapy with docetaxel and cisplatin and gefitinib~      Patients will be treated for 12 days with gefitinib 250 mg/day p.o. (d -12 to -1) and induced~     with chemotherapy docetaxel 75 mg/m2 and cisplatin 50 mg/m2 d1+2 and intercalated gefitinib~     250 mg/day d4-20 (cycle 1 and 2) and d4-17 (for cycle3). Surgery is planned in the 4th week~     after d1 of the last cycle.~   "
94801|NCT02326272|"~     The purpose of this study is to investigate the efficacy and safety of two dose levels of~     certolizumab pegol in adults with moderate to severe chronic plaque psoriasis.~   "
94802|NCT02326259|"~     The investigators are doing this research for two reasons. The first is to see how the retina~     (back of your eye) changes when your blood sugar is treated with medication for the first~     time. This will help us better understand the progression of a condition known as Diabetic~     Retinopathy. The second reason is to provide diabetic blood samples, which will possibly help~     identify biomarkers for diabetic retinopathy. Biomarkers are things that indicate the~     presence of a specific condition, and indicate a higher likelihood of developing that~     condition.~   "
94803|NCT02326246|"~     The purpose of this study is to investigate the hypothesis, that mMRI provides a more~     accurate and secure interpretation of the aggressiveness of prostate cancer initially/before~     mMRI defined as low risk. In doing so we will investigate and assess the affect of mMRI on~     gleason score upgrade, risk classification upgrade and changes in treatment strategy (active~     surveillance vs. operation).~   "
94804|NCT02326233|"~     The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of the~     pre-filled pen and pre-filled syringe of SB5 in healthy subjects.~   "
94805|NCT02326220|"~     This is a randomized, double-blind, placebo-controlled, parallel-group study to evaluate the~     effect of alirocumab in comparison with placebo on the frequency of LDL apheresis treatments~     in patients with HeFH undergoing LDL apheresis therapy.~   "
94806|NCT02326207|"~     The purpose of this study is to determine incidence of ventilator-associated pneumonia~     compared between weekly and no routine ventilator circuit changes in neonatal intensive care~     unit~   "
94807|NCT02326194|"~     Since its first outbreak occurred in 1976, Zaire Ebola virus have been associated with 14~     outbreaks reported up to 2014. The Zaire Ebola virus in 2014 causing the most serious~     outbreak was considered to be a new epidemic strain, with GP homology of the gene was only~     97.6%, compared to the GP gene of the strain in 1976. This investigational Ad5-EBOV vaccine~     was developed according to the 2014 epidemic Zaire strain and formulated as freeze-dry~     products which could be stored at 4℃.~      This is a single center, double-blind, placebo control, dose-escalation phase 1 clinical~     trial. This study will determine the safety and side-effect profile, and immunogenicity of an~     investigational Ad5-EBOV vaccine.~   "
94808|NCT02326181|"~     The study will investigate the effects of different training types ,including combined~     inspiratory with expiratory pressure threshold training,inspiratory pressure threshold~     training on patients with chronic obstructive airway disease and investigate whether~     expiratory pressure threshold training associated with inspiratory pressure threshold~     training would be better than inspiratory pressure threshold training alone, with regard to~     exercise capacity, respiratory muscle strength and endurance.~   "
94809|NCT02326168|"~     Approximately 25 subjects will be enrolled and receive a standard WHO adult potency BCG~     immunization (1cc/50mg live mycobacilli) in the deltoid. Following a wait period after BCG~     vaccination, patients will then receive standard strength BCG intravesical therapy once a~     week for a total of 6 weeks. The BCG is instilled and held in the bladder for approximately 2~     hours. While the BCG is retained in the bladder the patient should be repositioned every 30~     minutes to maximize bladder surface exposure to the agent. Patients will undergo a cystoscopy~     every 3 months following most recent TURBT. Study duration last approximately 6 months.~   "
94810|NCT02326155|"~     An observational, prospective cohort study to evaluate the safety and efficacy of Remsima™ in~     patients with Crohn's disease (CD) or Ulcerative Colitis (UC)~   "
94811|NCT02326142|"~     The primary objective of this study is to assess the efficacy of a single dose of OBE001, an~     oral oxytocin antagonist, given for up to 7 days to delay preterm birth by 7 days compared to~     placebo.~   "
94812|NCT02326129|"~     The investigators wants to determine if 11β-HSD1 activity will be positively associated, and~     5α-reductase activity negatively associated, with (a) degree of insulin resistance defined by~     the homeostatic model assessment of insulin resistance index (HOMA-IR) and (b) worsening~     glycemic control defined by higher HbA1c and impaired fasting glucose in a group of obese~     children and young adults with or without type 2 diabetes compared to lean children and young~     adults without diabetes. The investigators also want to identify key metabolic signatures~     associated with diabetes using metabolomic profiling.~   "
94813|NCT02326116|"~     The purpose of this study is to evaluate if Tracheal Traction Exercises (TTE) performed prior~     to anterior cervical spine surgery can result in a decreased rate of dysphagia.~   "
94814|NCT02326103|"~     The study is aimed to evaluate the additional role of ciprofloxacin therapy in severe~     alcoholic hepatitis combined to prednisolone therapy in an open-label placebo controlled~     manner.~   "
94815|NCT02326090|"~     The objective of the Phase 2 study is to compare the safety and efficacy of cis-UCA~     Ophthalmic Solutions to placebo for the treatment of the signs and symptoms of dry eye.~   "
94840|NCT02325765|"~     In this study，the investigators want to determine the corelation between circulating~     nuclearsome and the development of SIRS occured after congenital cardiac surgery, including~     the serverity of organ damage and inflamation.~   "
94841|NCT02325752|"~     The investigators conducted an open randomized control study of patients who received the~     transitional care program versus patients who received usual care at the Singapore General~     Hospital from Aug 2011 to Sept 2012.~   "
94842|NCT02325739|"~     Estimate the maximum tolerated dose and/or recommended phase II dose and efficacy of FGF401~     as single agent and in combination with PDR001 in patients with hepatocellular carcinoma and~     as single agent in patients with other solid malignancies.~   "
94816|NCT02326077|"~     Objectives:~        -  Evaluation of the correlation between the sonographic parameter and clinical findings~          (e.g. digital examination) in any cephalic (not only occipital anterior) position~        -  Examination of the relationship between various sonographic parameters~        -  Determination of intraobserver and interobserver variation in obtaining the sonographic~          measurements~        -  Analysis of the temporal variation of the different sonographic measurements in normal~          spontaneous vaginal delivery versus obstructed labor in fetuses with occiput anterior~          versus those with persistent occiput posterior~        -  Establishment of a sonopartogram that should replace in an objective way Friedmann~        -  Establishment of cut-off values that may help clinicians to choose between vaginal~          operative delivery or caesarean section~        -  Another interesting aspect of intrapartum transperineal ultrasound imaging is whether~          there is a psychological benefit to the patient in being able to follow on the~          ultrasound screen how fetal head descent and position are being assessed objectively.~   "
94817|NCT02326064|"~     Ovarian cancer is the fifth leading cause of cancer death in women worldwide. Most of these~     cancers are manifested in the form of an ovarian cyst. Practitioners are faced with two main~     difficulties. The first is to establish an early diagnosis. The second is to differentiate a~     benign tumor, a malignant tumor.~      To date, there is only one biological tumor marker routinely performed before an ovarian~     cyst, the CA-125 (cancer antigen 125). Unfortunately, many studies have been performed and~     show a sensitivity and specificity unsatisfactory in view of the severity of the disease.~      The principal investigator therefore propose to evaluate a new tumor marker, as well as its~     use in algorithms to help differentiate benign from malignant tumors, and allow earlier~     diagnosis in cases of ovarian cancer.~   "
94818|NCT02326051|"~     Evaluation of the effect of altering the timing of initiation of low molecular weight heparin~     (LMWH) administration on the pregnancy outcomes in women with antiphospholipid syndrome (APS)~   "
94819|NCT02326038|"~     Traditionally, memory impairments in the elderly population are treated using cholinesterase~     inhibitors, although impairments remain after treatment. Dopamine (DA) is also involved in~     cognition and is especially of interest in healthy ageing because of the role in processing~     speed and cognitive control. To what extent dopamine treatment improves memory and attention~     in older impaired individuals is unknown. However, such an effect is conceivable because of~     the close relationship between memory and attention in aging and since improved processing~     speed and cognitive control may lead to improved memory.~      The investigators aim to examine, in the impaired older population, whether a treatment using~     methylphenidate, a DA re-uptake inhibitor that enhances DA, improves attention and memory.~     The study will be conducted according to a cross-sectional, double-blind, placebo-controlled,~     2-way cross-over design. 20 male and female patients with Mild Cognitive Impairment (MCI),~     amnestic type, aged above 60 years of age; 20 male and female patients with MCI, non-amnestic~     type, will be recruited from the Orbis Medical Centre. Participants will be treated once with~     20 mg methylphenidate (MPH) and once with placebo. All medications will be administered~     orally with a capsule. The treatment order will be established by counterbalancing.~   "
94820|NCT02326025|"~     The purpose of this study is to assess how the body handles olaratumab when it is given with~     another drug called doxorubicin.~      The safety and tolerability of these drugs will be studied. Each participant will complete~     two 21-day cycles in a fixed order. Participants who complete Cycle 2 may continue to receive~     olaratumab + doxorubicin for an additional six 21-day cycles and then may receive olaratumab~     alone until discontinuation criteria are met.~      Screening is required within 21 days prior to first dose.~      Part B was added in October, 2015 to assess how the body handles a higher dose of olaratumab~     when given with doxorubicin.~      Participants may only enroll in one part.~   "
94821|NCT02326012|"~     The primary aim is to investigate the effectiveness of Emotion Regulation Individual Therapy~     for Adolescents (ERITA) who self-harm.~   "
94822|NCT02325999|"~     The purpose of this study is to determine whether Endoscopic Submucosal Dissection combine~     with Laparoscopic Regional Lymph node Dissection for early gastric cancer can improve~     Disease-free survival ？~   "
94823|NCT02325986|"~     The purpose of this study is to evaluate the efficacy and toxicity of radiotherapy~     concurrently with weekly chemotherapy of 5-FU and cisplatin in patients with postoperative~     locoregional recurrence of esophageal squamous cell carcinoma.~   "
94824|NCT02325973|"~     The purpose of this study is to assess whether the Index of Microcirculatory Resistance (IMR)~     can be considered a prognostic predictor for the occurrence of events at one year of follow~     up after primary Percutaneous Coronary Intervention (PCI) in ST-Elevation Myocardial~     Infarction (STEMI) patients.~      Any correlation between IMR and the short and medium term outcomes, defined as cardiovascular~     death, re-Myocardial Infarct (MI), re-hospitalization for Heart Failure (HF), resuscitation~     or Implantable Cardioverter Defibrillator (ICD) appropriate shock, will be assessed in the~     study.~   "
94825|NCT02325960|"~     This is a 16-week, Single-center, Randomized, Open Label, Parallel Controlled Group~     Comparison of the Comprehensive Glycemic Control of Exenatide and Insulin Glargine on Type 2~     Diabetes Patients Inadequately Controlled With Metformin Monotherapy.~   "
94826|NCT02325947|"~     The purpose of this study is to assess the efficacy of non-invasive BCI-exoskeleton~     technology based on EEG patterns recognition matching to motor imagery in post-stroke~     patients with hand paresis.~   "
94853|NCT02325583|"~     Newborn often sedated during MRI but sedation itself creates adverse events and management is~     more challenging in the MR environment. The investigators describe the investigators initial~     experience with oral 30% glucose administration through a pacifier during MRI for imaging of~     newborns. Using this technique, majority of newborns can complete MRI examination without the~     need for sedation and also offers the availability of administering sedatives to unsuccessful~     patients.~   "
94854|NCT02325570|"~     Multicenter, prospective, interventional open case series study using a randomized~     split-mouth design in moderate to severe chronic periodontitis patients having half-mouth~     treated with the KLOX BioPhotonic OraLum gel with a LED curing lamp as an adjunct to~     conventional non-surgical periodontal treatment (SRP) versus SRP alone in the second~     (control) half-mouth.~   "
94857|NCT02325531|"~     The investigators propose to compare the effectiveness of 3 strategies (low, medium, high~     intensity) at supporting CHCs' implementation of the ALL Initiative (an intervention shown to~     reduce patients' cardiovascular disease (CVD) event risk), through a cluster-randomized~     trial.~   "
94827|NCT02325934|"~     Elvitegravir is an HIV-1 integrase inhibitor which is marketed in a fixed dose combination~     tablet with cobicistat, tenofovir and emtricitabine (Stribild®, referred to as STB). For~     patients with swallowing difficulties, administration of whole tablets can be problematic and~     tablets are cut or crushed to ease administration. In addition if HIV patients develop~     opportunistic infections, patients can become severely ill and may end up on the intensive~     care. Patients at the intensive care might not be able to swallow medication. Therefore it is~     useful to know if it is possible to administer STB through a different route, like a feeding~     tube. If STB can be crushed or dissolved and given through a catheter it is also useful to~     know if it can be given with drip feed.~      Currently there is no information about crushing STB tablets. Crushing STB tablets into a~     liquid medium has not been studied and is not recommended according to the SPC text.~     Depending on the biopharmaceutical characteristics of a drug formulation, crushing tablets~     can lead to altered pharmacokinetics of drugs.~      It is important to know whether pharmacokinetics are influenced by crushing of tablets as low~     concentrations are associated with virologic failure. Therefore higher doses might be needed.~     In addition, higher Cmax and/or exposure can lead to toxicity. As a result therapeutic drug~     monitoring is advised, or crushing the drug is a contra-indication based on the available~     data.~      It has been shown that simultaneous oral ingestion of antacids and elvitegravir gives a~     decrease in Cmax and AUC of elvitegravir. This interaction is not shown for co-ingestion with~     omeprazole. Which makes it unlikely that this interaction is caused by a pH-lowering effect~     influencing the absorption of elvitegravir. It is probably a local gastrointestinal~     complexation phenomenon, similar to what has been observed with other HIV integrase~     inhibitors. A possible pharmacokinetic interaction between elvitegravir and complexation~     formers may be expected. Especially considering the active binding sites of elvitegravir~     which bind magnesium metal ion cofactors. Although there is data that STB can be ingested~     with a protein rich drink, it is unclear if foods or liquids containing high amounts of~     magnesium or other cations can cause this same interaction.~      Therefore this study will be conducted to investigate whether crushed and suspended STB and~     crushed and suspended STB with drip feed are bioe-quivalent to taking STB as a whole.~   "
94828|NCT02325921|"~     Diagnostic imaging for renal masses of unknown nature using conventional imaging modalities~     such as 3 phase contrast-enhanced computed tomography (CT) is not always conclusive. After~     (partial) nephrectomy, 10-20 % of the resected tumors show benign histology which could not~     be identified on diagnostic imaging. With improved imaging techniques available, leading to~     improvements in characterisation of renal tumors, the number of unnecessary resections may be~     reduced. The objective of this study is to evaluate the diagnostic performance of diffusion~     weighted magnetic resonance imaging (DW-MRl) in assessing the nature of renal masses,~     including the use of diffusion tensor imaging (DTI).Therefore patients >18 years of age~     scheduled for undergoing (partial) tumor nephrectomy will undergo one additional MRI~     examination.~   "
94829|NCT02325908|"~     The purpose of this study is to learn how the amount of fluid in the body of a hemodialysis~     patient affects him or her. Body hydration is the amount of fluid in the human body and known~     to be related to blood pressure. Too much fluid can lead to high blood pressure which can~     cause heart problems and eventually lead to death. Bioimpedance Spectroscopy (BIS) is a~     method that may be used to measure body hydration. This can be applied in the whole body,~     arm, trunk, calf, and leg. It is a non-invasive and inexpensive method and no known risk. BIS~     measurements can be used to assess optimal hydration status which is defined as a patient's~     ideal weight after completing a dialysis treatment. The investigators hypothesize that your~     target weight may be better estimated by the BIS. The results of this study, in particular~     the continuous measurement of calf hydration which is associated with the hydration of the~     whole body, may provide useful information about physiologic (healthy) body hydration. It~     may possibly help to improve treatment procedures for patients in the future. The Renal~     Research Institute plans to enroll 100 chronic hemodialysis patients and 200 healthy controls~     in this study.~   "
94830|NCT02325895|"~     The objective of the investigators current study was to examine whether 50 g dried plum would~     be as effective as 100 g dried plum in reversing bone loss in osteopenic older postmenopausal~     women.~   "
94831|NCT02325882|"~     The aim of this study to test hypothesis that addition of dexmedetomidine to fentanyl based~     intravenous patient controlled analgesia (PCA) improves postoperative pain compared with~     conventional thoracic epidural and intravenous patient controlled analgesia after radical~     open gastrectomy.~   "
94832|NCT02325869|"~     DebriS Interventional REmoval in ACS (DESIRE-ACS) Study to assess the safety and performance~     of the ECA Bell balloon in subjects undergoing coronary percutaneous interventions.~   "
94833|NCT02325856|"~     A reasonable and simple algorithm was used to guide the dry weight determination with Body~     Composition Monitor with the principle of Bioimpedance Spectroscopy (BCM-BIS) and analyze the~     feasibility of this algorithm and evaluate the influence of BCM-BIS-guided fluid management~     on the incidence of dialysis morbidities and clinical outcomes in maintenance hemodialysis~     (MHD) patients.~   "
94834|NCT02325843|"~     Ocular chemical burn is one of the cause of vision loss in our country, and there are no~     satisfactory treatment. Human bone marrow mesenchymal stem cells (MSC) have the biological~     characteristics of self-renewal, immune regulation, multidirectional differentiation and~     tissue repair. Our preliminary research showed that in corneal alkali injury rats, the MSC~     can accelerated the cornea repair, inhibited angiogenesis. The aim of this study is to access~     the efficacy and safety of mesenchymal stem cell in the treatment of corneal burn in human.~   "
94835|NCT02325830|"~     The objective of this prospective, multi-center, randomized, double-blind trial is to assess~     the safety and efficacy of the CARILLON Mitral Contour System in treating functional mitral~     regurgitation (FMR) associated with heart failure, compared to a randomized Control group~     which is medically managed according to heart failure guidelines.~   "
94836|NCT02325817|"~     The purpose is to observe and evaluate the safety and efficacy of Bingo drug-eluting balloon~     in the treatment of patients with bifurcation lesions of coronary artery.~   "
94837|NCT02325804|"~     The main purpose of this study is to assess metabolic effects (decreased amount of body fat~     content, insulin sensitivity and lipid profile improvement) of weight loss intervention based~     on specific life style counseling (low calorie metabolic stairs diet and circuit-based~     exercise in a comparison to conventional diet and exercise. The main hypothesis is that more~     significant beneficial metabolic effects will have specific life style counseling effect than~     conventional diet and exercise. The main purpose of this study is to assess above mentioned~     metabolic changes before and after 6-8 weeks of weight loss intervention.~      The investigators will also study the following:~        1. The impact of life style counseling induced weight and/or fat loss on physical fitness~        2. The impact of life style counseling induced weight and/or fat loss on metabolic~          parameters (e.g. insulin sensitivity, lipid profile, ect.)~   "
94858|NCT02325518|"~     The purpose of this study is to evaluate AZORGA® Ophthalmic Suspension compared to COSOPT®~     Ophthalmic Solution for IOP-lowering efficacy in subjects with open-angle glaucoma or ocular~     hypertension.~   "
94843|NCT02325726|"~     Postoperative acute renal failure is a frequent complication after cardiac surgery. The~     current practice cannot predict Acute Kidney Injuries (AKI) early enough to reduce a~     significant kidney assault and prevent an organic dysfunction leading to cortical tubular~     necrosis.~      Several recent studies in cardiac surgery have shown that, both sonographic criteria, such as~     the Renal Resistive Index (IRR) and urinary biomarkers can predict AKI promptly. These~     urinary biomarkers are the 'tissue inhibitor of metalloproteinases' (TIMP-2) and the~     'insulin-like growth factor binding protein' (IGFBP7). These two proteins are sought~     noninvasively, directly in the urine, within the same test called 'NephroCheckTM'. These~     markers, ultrasonographic and biologic, have the advantage of being easy to perform,~     accessible and seem to have both high sensitivity and specificity to predict AKI promptly~     after cardiac surgery. Thus, the IRR and the NephroCheckTM test could become essential tests~     to guide clinicians in determining rapidly whether a patient will develop AKI. However, so~     far, no study has compared these markers yet.~      Therefore, the aim of this prospective observational study will be to compare the~     effectiveness of the IRR with the NephroCheckTM to predict AKI promptly after cardiac~     surgery. The secondary outcome will be to determine the threshold of these markers from which~     patients will be likely to develop AKI~   "
94844|NCT02325713|"~     This is a phase I, open-label, randomized, 4 period, crossover, single-center trial. The~     purpose of this trial is to assess the relative bio-availability of racemate Oral Dispersible~     Tablet praziquantel (ODT-PQZ) (MSC1028703A) 150 milligram (mg) versus the current marketed~     praziquantel (PZQ) (Cysticide® 500 mg) formulation in healthy male volunteers.~   "
94845|NCT02325700|"~     This prospective study was designed to analyse the postoperative and long-term outcomes of~     total laparoscopic vs. open surgical repair of infra-renal abdominal aortic occlusive disease~     (AOD) and infra-renal aortic aneurysmal disease (AAA) in comparable groups of patients using~     a propensity analysis model.~   "
94846|NCT02325687|"~     Obstructive sleep apnea (OSA) is common and is a risk factor for postoperative complications,~     including respiratory and cardiac events and delirium. Despite this risk, however, there are~     currently no accepted biomarkers that can predict poor outcomes, making it unclear to see~     which patients will have complications after surgery, and who might need prolonged monitoring~     or an extended hospital stay. An improved understanding of the pathophysiology of OSA is~     required to identify potential biomarkers for outcomes after surgery, as well as to develop~     new treatments. The aim of this pilot study is to identify serum and cerebrospinal (CSF)~     biomarkers associated with obstructive sleep apnea (OSA). The presence of cytokines and~     neurotrophins will be determined and quantified in both patients with OSA and in controls.~     The CSF samples will additionally be analyzed by proteomic methods to identify potential~     biomarkers with significantly different levels present in patients with and without OSA. The~     working hypothesis is that OSA patients who are non-CPAP-compliant will have higher levels of~     circulating cytokines and lower levels of circulating neurotrophins in serum and CSF,~     compared to patients who are CPAP-compliant and/or controls.~   "
94847|NCT02325674|"~     Post Authorisation Safety Registry for US patients with Generalised Lipodystrophy treated~     with Metreleptin~   "
94848|NCT02325661|"~     The objective of this study is to translate the AKQoL-questionnaire which measures the~     quality of life of patients with actinic keratosis into German and to validate it for the~     Swiss population.~      By using the technique of cognitive interviewing the investigators are focussing on the~     patients' understanding of the questions. The first session of cognitive interviews will~     show, where there is need for improvement in terms of misinterpreted phrases or vaguely~     worded questions. The goal is to rephrase the questions according to the feedback of the~     patients. The revised version will then be presented to a new population.~   "
94849|NCT02325648|"~     The most popular surgical treatment of peritoneal cancer is the type known as hyperthermic~     intraperitoneal chemoperfusion (HIPEC), a type of cytoreductive surgery for which a~     significantly high survival rate has been demonstrated by several studies. It is widely known~     that HIPEC entails severe physiological changes and precautions during anesthesia. However,~     very few studies have systematically outlined and organized these changes for each system,~     and most existing studies only report retrospective data or are limited to gynecological~     surgeries. Therefore, the present researchers planned a prospective observational study to~     determine the physiological changes that occur in patients during HIPEC cytoreductive~     surgeries performed in the colon and rectal surgery department of the investigators hospital.~     The investigators planned to monitor the patients' body temperature, metabolism,~     cardiovascular and respiratory changes during HIPEC cytoreductive surgery and analyze the~     anesthetic methods applied to identify the optimal anesthetic management strategy for HIPEC~     cytoreductive surgeries.~   "
94850|NCT02325635|"~     Randomized prospective multi-site validation study.~   "
94851|NCT02325622|"~     The liver plays a crucial role in physiological glycemic control through its involvement in~     several glucose metabolism processes, including glycogenogenesis and glycogenolysis. Liver~     diseases result in impaired glucose metabolism due to hepatocyte dysfunction, termed as~     hepatogenous diabetes. Abnormal glucose metabolism is found in over 90% of patients with~     liver cirrhosis. and clinically significant diabetes is known to occur in 30% to 70% of the~     patients.~      A cohort study of cirrhotic patients with hepatogenous diabetes reported a relatively low~     diabetic complication rate, and the majority of mortality causes were complications related~     to liver cirrhosis; furthermore, mortality rate due to diabetic complications were reported~     to be low. Nonetheless, the average survival rate following the diagnosis of liver cirrhosis~     is rising due to increasing early detection rate and improvements in treatment modalities,~     and such rise in survival is expected to result in increased prevalence of hepatogenous~     diabetes and its complications. Therefore, it is necessary to formulate an accurate diagnosis~     of hepatogenous and to provide appropriate treatment.~      Analyses of the Diabetes Control and Complications Trial (DCCT) demonstrated an association~     between glycated hemoglobin (HbA1c) and mean plasma glucose concentration in diabetic~     patients, and currently, HbA1c is being employed as an appropriate marker in diagnosing~     diabetes mellitus and in monitoring the control of mean blood glucose.~      The association between mean plasma glucose concentration and HbA1c in cirrhotic patients has~     not been clearly established as of yet; however, HbA1c in cirrhotic patients is expected to~     be influenced by various factors resulted by liver cirrhosis and splenomegaly, including~     rapid erythrocyte turnover rate and other glycation processes.~      Therefore, HbA1c may not be an appropriate indicator in the diagnosis of hepatogenous~     diabetes or the monitoring of glycemic control; however, no systemic study on this issue has~     been performed so far. Therefore, the investigators are aiming to investigate the association~     between mean plasma glucose concentration and HbA1c in patients with compensated or~     decompensated liver cirrhosis who also have hepatogenous diabetes.~   "
94852|NCT02325596|"~     This study aimed to evaluate the upstream events of Th17/Treg imbalance in CRS and their~     immune regulatory factors. Then the investigators aimed to explore the regulatory role of~     miRNA on DC-Th axis and its dysfunction in the pathogenesis of CRS, in order to determine the~     miRNA expression profile in CRS and clarify the role of miRNA in the pathogenesis of CRS by~     regulating the DC-Th axis.~   "
94859|NCT02325505|"~     Tuberous Sclerosis Complex (TSC) is a multisystemic autosomal dominant disease that is~     characterized by the development of benign neoplasms in brain, kidney, lung, skin and heart.~     TSC is caused by mutations in TSC1 and/or TSC2 genes, which encode, respectively, hamartin~     and tuberin, that are involved in the regulation of cell proliferation, cell cycle and~     protein synthesis. Most patients exhibit dermatological, renal, neurological and pulmonary~     (lymphangioleiomyomatosis, LAM) manifestations. Neurological involvement include subependymal~     nodules, subependymal giant cell astrocytomas and cortical tubers. LAM is characterized by~     the proliferation of LAM cells around the airways, blood vessels and lymphatics, which result~     in vascular and airway obstruction and cyst formation. The most frequent TSC manifestation in~     the kidney is the development of angiomyolipomas (AML). Dermatologic lesions represent the~     most common manifestations of TSC, mainly hypomelanotic macules and facial angiofibromas. The~     most significant functional implication of the tuberin-hamartin complex is its regulatory~     role upon the mammalian target of rapamycin (mTOR) pathway. Mutations in TSC1 or TSC2 lead to~     increased mTOR activity and favor tumor development and growth. All lesions associated with~     TSC, sporadic LAM and sporadic AML share a common molecular pathogenesis, based on TSC1/TSC2~     mutations and mTOR hyperactivity. Up to date, TSC patients have been followed in separated~     medical services in our institution, according to their predominant phenotype. The current~     knowledge, however, suggest that the ideal follow up of such patients should be conducted in~     an integrated fashion among the specialties associated with the main disease manifestations.~     Experts in TSC from each of these areas have recently created a TSC/LAM/AML integrated~     program in the University of São Paulo Medical Center, and his project will be initiated with~     the generation of an integrated TSC/LAM/AML registry, which intends not only to clinically~     characterize this patient population but also to document the employed treatment modalities.~     Once this first goal is achieved, clinical trials are planned to be performed. The central~     aim of this observational study is to clinically characterize the TSC/LAM/AML subject~     population followed and referred to the University of São Paulo Medical Center. Specific~     aims: To characterize the pulmonary, the neurological, the renal and the dermatologic~     phenotypes of this patient population.~   "
94860|NCT02325492|"~     This is a one center, Phase IIa, randomized, double blind, placebo controlled study designed~     to evaluate the efficacy and safety of two Aramchol doses in subjects 18 to 75 years of age,~     with newly formed cholesterol gallstones in their gallbladder following bariatric surgery~     confirmed by gallbladder ultrasound ..~   "
94861|NCT02325479|"~     Heparin also has the ability to bind with and modulate a wide variety of proteins, which can~     influence a number of physiological processes involved in implantation & trophoblastic~     development. These processes include adhesion of the blastocyst to the endometrial surface &~     trophoblastic differentiation & invasion.~      A recent Cochrane review hinted towards research to study the possible effects of the local~     (uterine), & NOT SYSTEMIC application of heparin during Assisted reproductive technology~     (ART). Based on the above evidence the investigators hypothesize that low molecular weight~     heparin given intrauterine at mock embryo transfer after oocyte pick up will help improve~     pregnancy rates in patients undergoing ART.~   "
94862|NCT02325466|"~     The hypothesis being that both aspirin-ticagrelor and ticagrelor monotherapy will be superior~     to aspirin monotherapy in the reduction of whole blood viscosity at the end of each 4 week~     treatment period. Study participants will be randomized into 3 groups, and each group will~     receive each of 3 treatments in the cross-over study. At the end of each individual 4 week~     treatment period the investigators will determine whether there are differences in low and~     high shear rate dependent viscosity and investigate the effect of the treatment on peripheral~     arterial blood flow using pulse volume recordings, ankle brachial index and toe pressures.~     Subjects will be eligible if they have ankle-brachial index less than or equal to 0.85, or if~     a patient's blood vessels are calcified, patients will have toe-brachial index less than or~     equal to 0.6 performed using continuous-wave Doppler.~   "
94863|NCT02325453|"~     Gastric cancer represents a great challenge for health care providers and requires a~     multidisciplinary context in which surgery plays a main role.~      Minimally invasive surgery has been progressively developed, first with the advent of~     laparoscopy and more recently with the spread of robotic systems, but a number of issues are~     currently being debated, including the limitations in performing effective extended lymph~     node dissections and, in this context, the real advantages of using the robotic systems, the~     possible role for the Advanced Gastric Cancer, the reproducibility of completely~     intracorporeal techniques and the oncological results achievable during follow-up.~      A multicenter study with a large number of patients is now needed to further investigate the~     safety and efficacy as well as long-term outcomes of robotic surgery, traditional laparoscopy~     and the open approach.~   "
94864|NCT02325440|"~     A trial in patients with relapsing remitting multiple sclerosis (RRMS)~      Main objectives:~        -  To evaluate changes in the reconstitution of immune surveillance over time upon~          switching from natalizumab to fingolimod assessed by a change in the expression of~          CD49d.~        -  To evaluate changes in the migratory capacity of immune cells/peripheral blood~          mononuclear cells (PBMCs) upon switching from natalizumab to fingolimod in an in-vitro~          model of the blood-brain-barrier (BBB).~        -  To evaluate changes in paraclinical disease activity over time upon switching from~          natalizumab to fingolimod assessed by MRI (changes in Gd+, T2w lesions and DTI).~        -  To evaluate changes in T1w / FLAIR lesions upon switching from natalizumab to~          fingolimod.~   "
94865|NCT02325427|"~     This study is to investigate changes in brain activities in acute stroke patients , and to~     correlate findings with clinical outcome measures. Another aim of the study is to investigate~     whether transcranial direct current stimulation (tDCS) could improve motor function in~     subjects with poor brain activity after stroke. The brain activity will be measured by single~     and paired pulse TMS (transcranial magnetic stimulation). The study hypothesizes that:~        1. The neural mechanisms employed in patients who have different response to TMS~          stimulation are different. It is hypothesized that patients with no response upon TMS~          stimulation might have poorer motor function outcome, compared with patients with~          response upon TMS stimulation.~        2. The result of clinical outcome measures is related with TMS measurement.~        3. tDCS intervention is beneficial to subjects with poor brain activity. Clinical outcome~          measures will include a battery of upper limb motor tests such as upper extremity~          component of the Fugl-Meyer Assessment, Modified Ashworth scale for spasticity, box and~          block test, and manual muscle testing. Clinical outcome and TMS measurement will be~          assessed at within 2 weeks, 4-6 weeks and at 6 months post-stroke.~   "
94866|NCT02325414|"~     The overall objective of this study is to define an effective therapeutic approach, using~     currently available medication, to prevent or mitigate the loss of bone mass and bone~     strength that occurs after acute spinal cord injury.~   "
94901|NCT02324959|"~     The purpose of this study is to determine whether acupuncture and computer-based attention~     training can be combined for more effective post-stroke attentional deficits.~   "
94867|NCT02325401|"~     The purpose of this research study is to test the safety of adding metformin to standard of~     care. The standard of care treatment will be cisplatin once every 3 weeks for 3 treatments~     and radiation for 7 weeks.~      Metformin is a medication that is currently used to treat diabetes. Increasing amounts of~     metformin will be given to groups of patients already receiving normal treatment for their~     cancer to see if metformin causes any good effects by killing your cancer or bad effects~     (side effects).~   "
94868|NCT02325388|"~     Pressure ulcers are prevalent conditions that result in substantial financial costs to the~     healthcare system as well as significant distress to affected patients and their families.~     This study is a parallel two-group randomized controlled trial that aims to study how the use~     of a pressure sensing device with continuous visual feedback of pressure imaging may~     potentially decrease the interface pressure of patients who are at risk of pressure ulcers in~     an acute hospital setting.~   "
94869|NCT02325375|"~     Amyotrophic lateral sclerosis (ALS) is a fatal disease with progressive muscle weakness~     leading to severe disability and eventually death.Since the diagnosis relies on clinical~     features and electromyographic abnormalities, which may occur rather late in the disease~     course, there is a need to identify diagnostic tests that can confirm or exclude the~     diagnosis of ALS in the earlier phase of the disease.~      More recently, there are studies suggesting neuroinflammation to play a role for the~     development of ALS. Cluster of differentiation 163 is found to be up regulated in a large~     range of inflammatory diseases.~      At the investigators lab, pilot data (Kallestrup M et al, unpublished data) has shown~     promising results. There was an increased level of cluster of differentiation 163 (sCD163) in~     cerebrospinal fluid in 7 patients with ALS compared with controls.~      The purpose of the investigators study is to define the concentration of sCD163 in the~     cerebrospinal fluid and serum in patients with ALS compared with controls (patients with~     unspecified neurological symptoms). Furthermore, the investigators will define the~     concentrations of protein, glucose, immunoglobulin G index and other factors in the spinal~     fluid.~   "
94870|NCT02325362|"~     The purpose of this study is to demonstrate that Miglustat restores the function of the~     cystic fibrosis transmembrane conductance regulator (CFTR) in adult patients with cystic~     fibrosis homozygous for the F508del mutation.~   "
94871|NCT02325349|"~     The primary objective of this Phase II study is to evaluate the use of labelled RGD ligand in~     PET/CT to predict and/or to early assess the efficacy of chemotherapy including an agent with~     antiangiogenic effect.~      The predictive value of this approach will be determined by independent assessors on basis of~     data at the end of the treatment: RECIST 1.1 criteria for CT or MRI, PERCIST criteria for FDG~     PET/CT, clinical, endoscopic and histological findings.~   "
94872|NCT02325336|"~     Serious medication administration errors are common in hospitals. Various interventions were~     developed to help prevention of such errors such as bar-code technology. Investigators aimed~     to study the effect of bar-code-assisted medication administration (BCMA) system on the rate~     of medication errors in two hospitals.~      They will conduct a randomized controlled trial in 6 care units of two hospitals in Paris,~     France. Each unit will be randomized in either the control group or the intervention group~     using the bar-code system to help drug administration. The observation method will be used to~     evaluate the error rates in the 2 groups at baseline and when BCMA will be implanted. Nurses~     of the unit will be randomized to determine who will be observed during the administration~     rounds.~      Considering the results of a passed observational study in 4 units (Berdot, BMC Health Serv~     Research 2012) and the results of the study by Poon and al. (NEJM 2010), investigators~     estimated that 5.981 TOE (Total Opportunities for Errors) are needed to detect a relative~     reduction of 45% of error rate.~   "
94873|NCT02325323|"~     This prospective cohort study aims to assess the incidence of gastric cancer in patients with~     intestinal metaplasia in body of stomach or angular incisure.~      As secondary objectives, among the patients included in the cohort, the study will:~        -  assess the incidence of low grade dysplasia,~        -  assess the incidence of high grade dysplasia in patients with low grade dysplasia,~        -  identify risk factors of progression to dysplasia and gastric cancer.~   "
94874|NCT02325310|"~     In order to assess the safety of breastfed infants after their mother's postpartum~     immunization with a combined measles-mumps-rubella (MMR) vaccine, the purpose of this study~     is to investigate whether measles vaccine strain is excreted in breast milk of breastfeeding~     women with negative rubella and measles serologies.~   "
94875|NCT02325297|"~     After the death of a patient in the hyper-technical context of intensive care, his relatives~     are particularly vulnerable and often exhibit symptoms of anxiety, depression, post traumatic~     stress and complicated grief. The first results of a qualitative study Famiréa current~     (CAESAR) support the idea that the bereaved relatives suffer from persistent~     misunderstandings and a feeling of abandonment of the resuscitation team. Many families~     suggest the need for contact with the team after the patient's death. The letter of~     condolence received by some families allowed them to feel recognized in their pain~     resuscitation teams. This has led us to ask the question of post-death monitoring and~     interest to send to bereaved relatives a letter of condolence, as recommended by the American~     consensus conference in 2004 on good palliative care. This strategy would allow the~     recognition of both close to the pain but also the strong bond that united the resuscitation~     team. The hypothesis of the study is that the post-death followed in the form of a letter of~     condolence sent by the intensive care physician who was in charge of the patient, could~     reduce the risk of having symptoms of anxiety / depression and post-traumatic stress and~     reduce the rate of complicated grief.~      Famirea 22 is randomized clinical trial aimin to compare two bereaved groups: one group who~     did not receive a letter of condolence and a group that received a letter of condolence 15~     days after the death.~   "
94876|NCT02325284|"~     The development of tools for assessment and management of pain in newborns and children is a~     high priority and represents a significant unmet need. The inadequate treatment of pain and~     the overuse of analgesics can cause harmful consequences for neonates, infants, and children.~     To accomplish successful pain management in children one must first objectively assess pain.~     Thus, to address these critical issues with pain management, the Human Algometer and methods~     are under development by Drs. Julia Finkel and Zena Quezado, Pain Medicine Program (SZI) at~     Children's National Medical Center.~   "
94877|NCT02325271|"~     The study evaluates the intra-individual variability of VEGF levels over a period of 6 months~     as well as the circadian variation of VEGF levels, both under standardized conditions in~     patients with type 2 diabetes without DME and matched subjects with normal glucose tolerance~     (NGT). Secondary objectives of the study are to evaluate the relationship of individual~     VEGF-levels to biomarkers of inflammation, HbA1c and major cardiovascular risk factors.~   "
94878|NCT02325258|"~     The aim of the present study was to evaluate the ability of health-care professionals in~     addressing sepsis, and the impact of a telephone call upon receival of blood cultures in the~     clinical microbiology department, from a clinical microbiologist, in the early management of~     sepsis.~   "
94879|NCT02325245|"~     The purpose of this study is to investigate the effects of metformin to prevent frailty in~     pre-frail non-diabetic elderly. Several outcomes measured in this study are frailty status,~     quality of life, handgrip strength, gait speed, and serum myostatin levels.~      We hypothesize that metformin for 16 weeks could prevent frailty in pre-frail elderly.~   "
94880|NCT02325232|"~     Celiac disease (CD) is the most common chronic autoimmune enteropathy in Western Countries~     with an estimated prevalence ranging from 1:100 to 1:200. It is usually characterized by a~     benign course with clinical and histological remission, provided that a strict gluten-free~     diet (GFD) is followed by patients. Less frequently, CD can be characterized by a complicated~     course, when facing with a refractory disease (RCD) or with malignancies of the~     gastrointestinal (GI) tract, namely lymphoma and adenocarcinoma of the small bowel (SB).~     Different studies estimated a relative risk (RR) for neoplastic GI complications in CD~     ranging from 2 to 40 and from 10 to 60 for primary gut lymphoma and adenocarcinoma,~     respectively. Although uncommon, the discussed malignancies has a severe prognosis,~     reflecting the need for an early diagnosis. This project aims to establish an enteroscopic~     approach to improve the diagnostic timing and survival of CD patients at risk to develop SB~     tumors.~   "
94881|NCT02325219|"~     The purpose of this study is to demonstrate the superiority of CNTO 1959 (guselkumab) to~     placebo in the treatment of participants with moderate to severe plaque-type psoriasis (A~     common genetically determined, chronic, inflammatory skin disease characterized by rounded~     erythematous, dry, scaling patches).~   "
94882|NCT02325206|"~     Dapagliflozin has been effective at lowering glucose and hemoglobin A1c (HbA1C) in subjects~     with tpye 2 diabetes (T2DM), when studied as monotherapy as well as in combination with~     insulin or oral anti-diabetic medications.This lead to investigations if this therapy would~     also be of benefit in type 1 diabetes as intensive insulin therapy is associated with glucose~     fluctuations, hypoglycemia, weight gain, and subsequent insulin resistance, all of which may~     reduce efficacy.~      The purpose of the pilot study is to collect clinical data on the HbA1c-dependent effect of a~     single-dose of 10mg dapagliflozin on the insulin dose administered intravenously during a~     glucose-infusion and an oral mixed-meal for the ensuing 24 hours with blood glucose kept~     between 160 - 220 mg/dl.~      The first objective is to investigate the degree of insulin dose reduction 24 hours after a~     single dose of 10mg dapagliflozin in patients with type 1 diabetes Further objectives are to~     investigate~        -  the effect on urinary glucose excretion~        -  if this effect is influenced by baseline glycemic control~        -  if dapagliflozin influences postprandial insulin need~        -  if dapagliflozin is associated with elevated ß-hydroxybutyrate levels~        -  PK after oral administration of 10mg dapagliflozin~   "
94883|NCT02325193|"~     The Minimed®640G system (MM640G) consists of a combination of insulin and glucose sensor for~     continuous glucose monitoring (CGM). Here, the glucose sensor transmits not only the~     continuous glucose data on the display of insulin pump but, in the case of hypoglycemia also~     interrupt their insulin delivery of pump. In the currently available system Paradigm®VEO, the~     interruption takes place at a settled threshold level. In difference in the new system MM640G~     the shutdown algorithm can already be proactive and help avoid hypoglycemia completely. The~     so called PLGM algorithm (predictive low glucose management) should be tested in the user~     evaluation. The main objective is to answer the question of reducing the rate of hypoglycemia~     by application of the new PLGM algorithm.~      Included are a total of 24 patients, aged 1-21 years, in three pediatric diabetes centers.~   "
94884|NCT02325180|"~     This is a prospective, open label, randomised controlled trial to assess the safety and~     efficacy of dihydroartemisinin-piperaquine and artemether-lumefantrine in children and adults~     with uncomplicated Plasmodium falciparum malaria infection. Molecular markers for~     antimalarial resistance will also be assessed and the presence of molecular markers in the~     parasites will be associated with treatment outcomes.~   "
94885|NCT02325167|"~     The purpose of the study is to test the effectiveness of a short-term manualised individual~     psychotherapy, called Existential Behavioural Therapy (EBT), to prevent depression in~     informal caregivers of palliative patients.~   "
94886|NCT02325154|"~     We plan to investigate the relationship between hypotensive epidural anesthesia for hip~     arthroplasty and cerebral oxygen saturation.~   "
94887|NCT02325141|"~     Leakage is the most common complication after laparoscopic sleeve gastrectomy which may~     amount to 20% in some studies. We hypothesize that Clostridium botulinum neurotoxin A (BTX-A)~     injection into the pyloric sphincter during the operation may decrease the risk of~     postoperative gastric leakage.~   "
94888|NCT02325128|"~     Investigators will examine whether post-exposure naps can be used to strengthen therapeutic~     extinction memories formed during exposure therapy for extreme social anxiety. Thirty-two~     individuals with high levels of social anxiety, evidenced by scores of 60 or greater on the~     Liebowitz Social Anxiety Scale, by self-report during a clinical interview and by~     demonstrated enhanced psychophysiological reactivity when imagining a socially stressful~     scenario, will be enrolled as one of four participants in one of eight successive offerings~     of a validated 5-session exposure-based group treatment for extreme social anxiety. The third~     and fourth sessions conclude with each participant delivering a speech on a topic~     individually chosen to elicit significant social anxiety. Following these sessions,~     participants will go to the sleep laboratory where two will be given a 2-hour sleep~     opportunity with polysomnographic (PSG) monitoring and two will be similarly instrumented but~     undergo 2 hours of monitored quiet wakefulness. Before and after treatment, participants will~     be individually assessed for social anxiety symptoms using standardized self-report~     instruments and a Trier Social Stress Test (TSST) modified for continuous psychophysiological~     monitoring. Ambulatory monitoring of home sleep will also be obtained using actigraphy and~     sleep diaries. The investigators hypothesize that, post treatment, those individuals who~     napped will show greater questionnaire-based clinical improvement as well as lesser~     psychophysiological reactivity during the modified TSST compared to those who remained~     quietly awake. The investigators further hypothesize that characteristics of sleep quality~     and architecture during naps, specifically durations of total sleep, REM and slow-wave sleep,~     as well as REM continuity, will predict greater clinical improvement and lesser~     psychophysiological reactivity to the TSST in those who napped following their third and~     fourth therapy sessions. Positive results will provide the first proof-of-principle for sleep~     augmentation of exposure therapy for clinically significant extreme social anxiety.~   "
94889|NCT02325115|"~     Background: Despite current popularity, positive mental health is under researched. This is~     possibly due to a lack of consensus on appropriate measuresThe Warwick-Edinburgh Mental~     Well-Being Scale (WEMWBS) is a 14 positively phrased Likert-style list of items developed to~     measure mental well-being. Its validation has been internationally explored. This report~     presents the French validation of the WEMWBS (F-WEMWBS) in non-clinical and clinical~     populations.~      Methods: Two non-clinical populations comprised of 319 working adults (WORK), and 75 students~     (STUD), and one clinical population of 121 patients with remitted schizophrenia (PRS) were~     included in the validation study. Participants completed the F-WEMWBS as well as~     complementary measures of psychological constructs potentially related to well-being.~   "
94890|NCT02325102|"~     Co-occurence of multiple pathogens in children is a known phenomenon, however the potential~     effect on the probability to develop a disease and on its severity, as well as the~     relationships between them, has not been studied adequately.~      In this study, children admitted to the pediatric department with a clinical presentation of~     an infectious disease were tested for the presence of multiple pathogens. Data about their~     clinical status and about the accessory examinations performed during hospitalization were~     collected and analyzed.~   "
94891|NCT02325089|"~     Sleep apnea involves significant increases in disease and death, but its consequences in~     people over 65 years of age are incompletely recognized. Intraoral mandibular advancement~     appliances reduce the number of apneas and hypopneas. The investigators hypothesized that~     oral appliances provided to the elderly may prevent hypertension and other consequences of~     sleep apnea in large populations, at a favorable cost/benefit relationship for the public~     health system.~   "
94892|NCT02325076|"~     The airflow moving from mouth to the lungs, which can be measured by pulmonary function~     tests, may be affected by the anatomic disorders of the upper airway. Difficult airway can be~     considered as the anatomic disorder of the upper airway as well. Therefore, there can be a~     relationship between difficult airway and pulmonary function tests. The purpose of this study~     is to elucidate the association between the pulmonary function tests and difficult airway.~   "
94893|NCT02325063|"~     The primary objective of this study is to compare the evolution of pain profiles among~     patients suffering from lateral epicondyalgia (tennis elbow) following three types of~     treatment: PRP-L injection versus type A botulinum toxin injection versus corticoid~     injection.~   "
94894|NCT02325050|"~     The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and~     Ad26.ZEBOV as heterologous and homologous prime-boost vaccine regimens in healthy adult~     participants.~   "
94895|NCT02325037|"~     The purpose of this First-in-Human study is to evaluate the safety and tolerability after~     single ascending oral doses of GLPG1837 given to healthy subjects, compared to placebo. Also,~     the safety and tolerability of multiple ascending oral doses of GLPG1837 given to healthy~     subjects daily for 14 days compared to placebo, will be evaluated.~      Furthermore, during the course of the study after single and multiple oral dose~     administrations, the amount of GLPG1837 and its metabolite present in the blood and urine~     (pharmacokinetics) will be characterized.~      The effect of food on the pharmacokinetics of GLPG1837 and its metabolite will also be~     evaluated.~      The potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1837 will~     be explored as well.~   "
94896|NCT02325024|"~     The study aims to determine the pharmacokinetic (PK) profile of a single oromucosal dose of~     Sativex® (i.e. how the body absorbs, distributes, metabolises and excretes the drug) when~     subjects have severe renal impairment or end stage renal disease (ESRD), compared with~     subjects who have normal renal function.~      The primary clinical hypothesis is that there will be an effect from severe renal impairment~     on the PK of Sativex® when administered as a single oromucosal dose.~      The study additionally aims to evaluate the safety and tolerability of the same single~     oromucosal dose of Sativex® in subjects with severe renal impairment or ESRD.~   "
94897|NCT02325011|"~     The study aims to evaluate the effect of fluconazole on the pharmacokinetic (PK) profile of a~     single oromucosal dose of Sativex® (i.e. how the body absorbs, distributes, metabolises and~     excretes the drug) in healthy subjects with a history of cannabis use.~      The primary clinical hypothesis is that no drug-drug interaction between Sativex® and~     fluconazole will be detected as effects on PK parameters of Sativex®, when both are~     administered to healthy human volunteers who have experience using cannabis.~      The study additionally aims to evaluate the safety and tolerability of an oromucosal dose of~     Sativex® in subjects when given concurrently with fluconazole.~   "
94898|NCT02324998|"~     Despite recent advances in the treatment of Castrate-Resistant Prostate Cancer (CRPC), there~     remains an unmet medical need to identify and optimise additional treatment for those~     patients with early prostate cancer who are at greatest risk of relapse following first-line~     treatment with curative intent.~      This is a phase I study investigating the feasibility and tolerability of a short course of~     neoadjuvant treatment with olaparib, either as a monotherapy or in combination with~     degarelix) given in the window-of-opportunity prior to radical prostatectomy in men with~     early, localised intermediate-/high- risk prostate cancer. Our primary objective is to~     determine the pharmacodynamic biomarker effects of olaparib (a PARP inhibitor) in this~     patient population.~      Participants will receive either single agent olaparib or olaparib in combination with~     degarelix (androgen deprivation) for two weeks prior to routine radical prostatectomy. We~     will use immunohistochemistry to quantify changes in the levels of biomarkers of PARP~     inhibition, e.g. PAR, gamma H2AX, pH2A(s129) and Rad51 foci, using tumour samples taken at~     baseline and at the time of radical prostatectomy. An intra-operative prostate biopsy will~     permit us to examine biomarker variability between the samples.~      The incidence and severity of Adverse Events will be documented and we will assess the number~     of trial participants who undergo surgery on schedule. We will assess preliminary evidence of~     tumour response, e.g. pathological changes and Prostate Specific Antigen (PSA). We also~     intend to investigate changes to the ctDNA profile by comparing blood samples collected~     throughout the study.~   "
94899|NCT02324985|"~     This study is designed to evaluate the analgesic safety and efficacy of study drug (AP0302)~     applied topically every 6 hours as compared to a vehicle, in subjects experiencing delayed~     onset muscle soreness.~   "
94900|NCT02324972|"~     The primary objective of this study is to evaluate the effect of 12 weeks of treatment with~     once daily administration of AQX-1125 compared to placebo on change from baseline in Target~     Lesion Symptom Score in subjects with mild to moderate atopic dermatitis~   "
94903|NCT02324933|"~     This study will evaluate the value of dosing pain medications based upon a patient's~     pre-operative tolerance to pain medications. Study participants will be assigned to one of~     two groups, a treatment group and a control group. The treatment group will be given pain~     medications after surgery based upon their measured response to pain medications prior to~     surgery. The control group will be given pain medications based upon the normal dosing~     routine as is currently practiced. Both groups will be closely monitored for side effects and~     have their pain scores recorded for the first 48 hours following surgery.~   "
94904|NCT02324920|"~     The purpose of this study is to assess whether the Closed Loop Stimulation (CLS) in addition~     to the DDD pacing is effective in reducing syncopal recurrences. The study hypothesis is that~     DDD pacing with CLS stimulation is able to prevent syncopal recurrences completely or~     partially by transforming syncope in pre-syncope.~   "
94905|NCT02324907|"~     The purpose of this study is to determine the clinical efficacy of a novel dynamic~     compression intramedullary nail for tibiotalocalcaneal (TTC) arthrodesis.~   "
94906|NCT02324894|"~     Mammography remains an imperfect screening test especially in women with extremely dense~     breast tissue, missing biologically aggressive cancers especially in younger population and~     picking up indolent cancers that do not need treatment.~      The most sensitive test for breast cancer detection at our disposal is magnetic resonance~     imaging (MRI). The preliminary study of Dr Kuhl provide strong arguments that Ultra FAST~     Breast Magnetic Resonance is suitable for breast cancer screening with high sensitivity and~     specificity values.~      Data clearly demonstrates that FAST breast MRI could be the standard for breast cancer~     screening: it is safe, does not induce cancers, and can find more cancers than mammography.~      However this study was performed in women with low to moderately increased risk.The value of~     FAST Breast Magnetic Resonance in normal screening population has to be assessed before a~     modification of current strategy of breast cancer screening with mammography.~   "
94907|NCT02324881|"~     This pilot clinical trial studies a pain management smartphone application for monitoring~     pain in patients with locally advanced head and neck cancer who are undergoing radiation~     therapy. The study is also open to patients with esophageal or lung cancer. A smartphone~     application may allow patients to assess their symptoms in a manner that is closer to~     real-time than having to recall pain episodes during once weekly on-treatment visits with a~     health care provider. This real-time monitoring may improve the timing and efficacy of~     interventions leading to better pain-control and quality of life.~   "
94908|NCT02324868|"~     Venous catheters are necessary for the treatment of many patients. Showering with a venous~     catheter is often prohibited due to the infection risk when the insertion site becomes wet.~     Therefore these patients are challenged to keep the catheter insertion site dry and always~     covered with a dressing. Washing themselves is often impossible without assistance of a nurse~     or significant other. For patients with a catheter connected to an infusion line, it is even~     more difficult. Showerpatch is a newly developed dressing that safeguards the insertion site~     of an IV catheter from water during bathing activities. The purpose of this trial is to~     evaluate the impact of the availability of Showerpatch by comparing the outcomes in patients~     regarding the patient's autonomy in bathing activities, the material use and the time needed~     from caregivers in home care. Additionally qualitative data on patient's bathing activities~     and the use of Showerpatch will be collected.~   "
94909|NCT02324855|"~     The main aim is to analyze whether the routine use of chest physiotherapy in non cystic~     fibrosis bronchiectasis (NCFB) improves the cough severity and the quality of life in this~     population. In addition, the secondary end-points include incidences of exacerbations,~     changes in lung function, exercise capacity, airways inflammation, sputum analysis and~     eventual adverse events.~   "
94910|NCT02324842|"~     Specific Aim 1.To examine whether the combination of liraglutide plus canagliflozin can~     prevent the increase in HGP following institution of canagliflozin therapy and produce an~     additive or even synergistic effect to lower the plasma glucose concentration and A1c.~      Specific Aim 2: To examine whether combination therapy with liraglutide plus canagliflozin~     can produce an additive, or even synergistic, effect to promote weight loss and reduction in~     hepatic and visceral fat content.~      Specific Aim 3. To examine whether combination therapy with liraglutide plus canagliflozin~     can produce an additive or even synergistic effect to reduce systolic/diastolic blood~     pressure and 24-hour integrated blood pressure.~   "
94911|NCT02324829|"~     Physiotherapists spend a large amount of their time with patients observing their~     rehabilitation techniques. A patient going through rehabilitation exercises are routine and~     does not necessarily require the attention of the physiotherapist. This research will develop~     a sensor system that will be strapped onto the patients and will provide feedback on how~     accurately the exercise is being executed. This will free up the physiotherapist to focus on~     diagnosis and other tasks that will better utilize the physiotherapist's training. A previous~     study has shown that this system is feasible for healthy subjects. This study would test to~     see if this system is extendable to rehabilitation subjects.~   "
94912|NCT02324816|"~     Evaluate the performance of a cryolipolysis system using a colder treatment parameter for~     non-invasive reduction of subcutaneous fat in the lateral thighs.~   "
94913|NCT02324803|"~     assess the activity and toxicity of second-line treatment with pazopanib after failure of~     first-line sunitinib treatment in patients with clear cell mRCC; to investigate the potential~     association of DLL4, Notch1, VEGFA, PDGFRB, HIF-1α and HIF-2α with clinical response to~     pazopanib in mRCC patients.~   "
94914|NCT02324790|"~     This is a pilot study to investigate the efficacy and safety of the Negative Pressure Sleep~     Therapy System for the treatment of obstructive sleep apnea.~   "
94915|NCT02324777|"~     Primary Objective:~      - To determine the analgesic dose-response characteristics of vapourized cannabinoids with~     varying degrees of delta-9-tetrahydrocannabiol (THC)/ Cannabidiol (CBD) ratios.~      Secondary Objectives:~        -  To compare functional changes and patient preferences of different cannabinoid (THC,~          CBD) profiles in patients with OA (Osteoarthritis);~        -  To describe the Pharmacokinetics (PK) of vapourized cannabis of differing cannabinoid~          profiles in patients with OA;~        -  To explore the short term safety of vapourized cannabis with different cannabinoid~          profiles.~        -  To describe the incidence and severity of psychoactive events.~   "
94917|NCT02324751|"~     Using an established model of human typhoid infection, whereby healthy adults are~     deliberately exposed to typhoid-causing bacteria, the investigators will determine how~     effective a new typhoid conjugate vaccine (Vi-TCV) is in preventing infection. The new~     typhoid vaccine will be compared with a control vaccine (meningococcal ACWY). The protective~     effect of a currently used typhoid polysaccharide vaccine (Vi-PS) will also be studied and~     compared with the control vaccine using this model of typhoid infection.~      A second component of this study will involve vaccinating 15-20 participants with Vi-PS.~     Serum will be obtained prior to vaccination and 4-6 weeks after vaccination. The~     post-vaccination serum will be pooled and used to create an anti-Vi IgG serum standard.~   "
94918|NCT02324738|"~     This is an open-label sequential pharmacokinetic study in 16 healthy glucose-6-phosphate~     dehydrogenase (G6PD) normal Thai subjects at Faculty of Tropical medicine, Mahidol~     university.~      The 16 subjects have already participated in a healthy volunteer studies in the past either~     i) Open-Label Study to Evaluate Potential Pharmacokinetic Interaction of Orally Administered~     primaquine and dihydroartemisinin-piperaquine (DHA-PQP) in Healthy Adult Subjects or ii)~     Comparison of the electrocardiographic effects in relation to Pharmacokinetic profile of~     chloroquine and piperaquine in healthy Thai subjects~      Every subject was administered a single dose of three tablets of DHA-PQP from previous~     studies. To avoid unnecessary exposure of DHA-PQP again, we propose to include the results of~     DHA-PQP arm from these previous studies and ask the healthy subjects to participate this~     study for receiving only single dose of three tablet of DHA-PQP (40mg/320mg) and two tablet~     of Mefloquine (250mg) on first admission and single dose of two tablet of Mefloquine on~     second admission.~   "
94919|NCT02324725|"~     This study evaluates the biological markers of treatment of opioid dependent individuals with~     an extended release formulation of the opioid antagonist naltrexone. The biological measures~     include functional MRI, blood levels of naltrexone and its metabolites, urine toxicology and~     behavioral tests probing various aspects of personality, memory, reward processing and~     attention.~   "
94920|NCT02324712|"~     Purpose: 1) To investigate differences in pro-inflammatory and anti-inflammatory cytokines~     and growth factors in the circulating blood (and cytokine levels only in saliva) of patients~     with chronic temporomandibular disorder (TMD) before and after acupuncture; 2) To determine~     differences in cytokine profiles between real and sham acupuncture in circulating blood of~     patients with chronic TMD; and 3) To explore correlations between these changes and clinical~     outcomes.~      Participants: Patients with chronic TMD pain recruited through the University of North~     Carolina-Chapel Hill (UNC-CH) Orofacial Pain Clinic.~      Procedures (methods): Participants will complete a self-administered questionnaire assessing~     TMD-related comorbidity. During the initial visit, study examiners will record clinical~     characteristics of muscles and joints of the head, neck and body according to newly~     recommended diagnostic criteria (DC) for TMD. Clinical outcomes include a pain index~     (computed from numeric rating scales) of masseter, temporalis and the supplemental painful~     muscles, and patient-reported symptoms (using the Measure Yourself Medical Outcome Profile;~     MYMOP) and pain intensity (using the Pain Scale). Blood (5 cc) will be taken before and after~     acupuncture treatments. Participants will self-collect pre-treatment and post-treatment~     saliva samples. Patients will receive 4 acupuncture treatments, once per week for 4 weeks.~     The primary outcome measure is change in IL-8 levels in circulating blood and saliva after 4~     weeks of real acupuncture compared with sham acupuncture. Secondary outcome measures include~     comparing changes in levels of nerve growth factor (NGF), tumor necrosis factor-alpha~     (TNFα),vascular endothelial growth factor (VEGF), platelet-derived growth factor (PDGF),~     basic fibroblast growth factor (bFGF), and IL-1α, IL-2, IL-4, IL-6 and IL-10, before and~     after real acupuncture at Week 1 compared with sham acupuncture and before and after real~     acupuncture at Week 4 compared with sham acupuncture. The exploratory outcome measure is~     correlation between changes in cytokine levels and clinical variables after 4 weeks of real~     acupuncture compared with 4 weeks of sham acupuncture.~   "
94921|NCT02324699|"~     Use of co-induction with corticosteroid therapies may accelerate the remission rate when used~     with vedolizumab. Further, this may lead to higher rates of response and remission at week 10~     than would be seen with vedolizumab monotherapy.~   "
94922|NCT02324686|"~     The purpose of this study is to determine whether vitamin K supplementation will improve~     anticoagulation control in patients on hemodialysis taking warfarin for atrial fibrillation.~     Patients who participate will receive vitamin K1 three times a week on dialysis days for a~     period of four months. INR levels collected during this period will be compared to the four~     month period prior to receiving the vitamin K1 to determine if vitamin K improves the~     standard deviation of INRs and time in therapeutic range.~   "
94923|NCT02324673|"~     This is a Phase 1/2, open-label trial designed to assess the pharmacokinetics, safety,~     tolerability, and preliminary efficacy of 3 multiple ascending doses of Cannabidiol Oral~     Solution in a sequential fashion.~      Participants will be pediatric (aged 1-17, inclusive), experiencing treatment-resistant~     seizures, and satisfy all inclusion/exclusion criteria.~   "
94924|NCT02324660|"~     Several studies and registries suggested that the concomitant presence of acute coronary~     syndromes (ACS) and chronic obstructive pulmonary disease (COPD) is significantly associated~     with poor prognosis. It has been suggested that diagnosis of COPD is frequently missing.~     Thus, it is plausible that a significant percentage of patients with ACS may have~     unrecognized COPD. This missing diagnosis may contribute significantly to poor prognosis. The~     investigators suppose that the concomitant use of peak expiratory flow (PEF) measurement and~     of Respiratory Health Screening Questionnaire (RHSQ, adapted version) could be useful as~     screening test for COPD in patient smokers or former smokers admitted to hospital with a~     diagnosis of ACS. In all screened patients COPD diagnosis will be confirmed (or not) two~     months after hospital discharge with spirometry. In the same setting of patients, the~     investigators will characterize the underlying pathological mechanisms, evaluating several~     inflammation, platelet and endothelial markers.~   "
94925|NCT02324647|"~     Standard diagnostic work-up for adrenal incidentalomas (AI) consists of periodical~     biochemical analysis and CT-scanning in case the initial work-up does not demonstrate the~     presence of hormonal hypersecretion or adrenocortical carcinoma (ACC), respectively. The~     overall aim of this study is to improve the cost-effectiveness of the diagnostic strategy for~     AI. Cost-effectiveness of urine steroid profiling (USP) will be compared to the standard~     diagnostic strategy of repeated CT-imaging.~   "
94993|NCT02323763|"~     The investigators propose to explore the link between bipolar disorder, anxiety, and suicide~     by investigating intertemporal discounting in depressed, suicidal patients with bipolar I and~     II disorder who have various levels of anxiety. The investigators will determine the effect~     of anxiety on their intertemporal discounting (small rewards now compared to larger rewards~     later) in a decision-making paradigm and investigate the associated functional neuroanatomy~     using functional magnetic resonance imaging (fMRI).~   "
96095|NCT02309346|"~     Septic abortion is a serious condition. Women with septic abortion are treated with~     clindamycin plus gentamicin using divided doses, i.e., thrice a day.~      The objective of this study is to compare the rates of cure between once or thrice a day use~     of clindamycin with gentamicin in cases of septic abortion.~   "
94926|NCT02324634|"~     Stroke is the largest cause of adult disability in the United Kingdom. Loss of hand function,~     muscle weakness, pain, and joint deformities are persistent and disabling problems for nearly~     half of all stroke survivors. This can, in part, result from patients not getting adequate~     therapy targeting the hand and arm in the very early stages of rehabilitation. Previous~     research has highlighted the importance of early rehabilitation interventions after stroke.~     Although in stroke patients the damage is to the brain rather than the limbs, muscle wastage~     (atrophy) can occur soon after stroke through non-use. Muscle atrophy can even occur in those~     who have retained some degree of active arm movement. Electrical stimulation (ES) is a~     painless treatment in which small pulses of electrical current from a battery operated~     portable device are used to activate a paralysed muscle and produce a strong muscle~     contraction. ES has been shown to increase brain activity and can hence influence the~     formation of new nerve pathways (known as neuroplasticity) to replace those damaged by~     stroke. Previous studies have concluded that six weeks of ES to the muscle on the back of the~     forearm improved the chance of a person recovering arm function. However, as the intensity of~     treatment was not sufficient to prevent the complications identified in this proposal, the~     impact of any functional benefit was significantly limited. We plan to build on previous~     research by training clinical therapists to operate ES devices; starting ES much earlier~     after stroke; applying a higher intensity treatment to more of the forearm muscles (i.e. both~     the front and back of the forearm) and providing treatment for a longer period of time than~     previously carried out. We will evaluate the feasibility of incorporating ES into a patient~     self-management programme to enable independent use outside of routine therapist led~     rehabilitation sessions.~   "
94927|NCT02324621|"~     This phase I trial studies the long-term side effects of the continuation of oral ONC201 in~     treating patients with solid tumors that have spread to other places in the body who have~     previously benefited from receiving this drug. Oral ONC201 may stop the growth of tumor cells~     by blocking some of the enzymes needed for cell growth.~   "
94928|NCT02324608|"~     This pilot clinical trial studies the side effects and how well cetuximab before surgery~     works in treating patients with skin cancer that forms, grows, and spreads quickly and has~     spread from where it started to nearby tissue or lymph nodes. Monoclonal antibodies, such as~     cetuximab, may block tumor growth in different ways be targeting certain cells. Giving~     cetuximab before surgery may make the tumor smaller and reduce the amount of normal tissue~     that needs to be removed.~   "
94929|NCT02324595|"~     Phase II multicentric study~   "
94930|NCT02324582|"~     This is a single center Phase I safety and efficacy study of MK-3475 therapy used in~     combination with bladder infused BCG treatment for patients, 18 years or older, with high~     risk superficial bladder cancer (cancer not yet involving the muscle of the bladder wall) who~     have had removal of their bladder tumor. Patients will be enrolled to a single treatment~     group of a fixed dose of MK 3475 and BCG.~   "
94931|NCT02324569|"~     The purpose of this study is to evaluate the efficacy and safety of SYR-472 when administered~     at a dose of 100 mg once weekly as an add-on to insulin therapy (SYR-472 100 mg~     combination/SYR-472 100 mg combination group) using insulin preparation alone/ SYR-472 100 mg~     combination group as a control in patients with type 2 diabetes mellitus and inadequate~     glycemic control despite treatment with insulin preparations in addition to diet and/or~     exercise therapy; and to evaluate the long-term efficacy and safety of SYR-472 when~     administered at a dose of 100 mg once weekly as an add-on to insulin therapy in patients with~     type 2 diabetes mellitus and inadequate glycemic control despite treatment with insulin~     preparations in addition to diet and/or exercise therapy.~   "
94932|NCT02324556|"~     All patients planned for an anterior resection due to rectal cancer with a total mesorectal~     excision are included. This is a feasibility study, thus no randomization will be performed.~      Primary endpoint is clinical and pathologic examination of the specimen. Secondary end-points~     include clinical variables such as conversion rate, re-admission and/or re-operation due to~     any complication and health economy analyses.~   "
94933|NCT02324543|"~     This study will be looking at whether gemcitabine, taxotere, and xeloda (GTX) in combination~     with cisplatin and irinotecan is effective (anti-tumor activity) and safe in patients with~     metastatic pancreatic cancer.~   "
94934|NCT02324530|"~     This is a clinical study on patients to compare the effects of CPAP on lung volume diaphragm~     motion, heart position and tumor motion compared to free breathing. Only patients with~     significant tumor motion of greater than 1 cm amplitude or unfavorable chest wall geometry~     (heart close to chest wall) identified on standard imaging and simulation will be candidates~     for the study. Patients will be re- simulated and planned for radiation treatments with CPAP.~     The radiation plans generated with and without CPAP will be compared to evaluate the impact~     of CPAP on tumor motion and dose delivered to adjacent critical structures such as the heart~     and lung.~   "
94935|NCT02324517|"~     Therapy of patients with severe hemophilia (including hemophilia with inhibitors) and other~     severe bleeding disorders could be monitored and guided based upon special clotting assays ,~     eg thrombin generation and thromboelastography. In this study blood sampled from patients~     with bleeding disorders will be evaluated applying ex- vivo spiking assays with various~     coagulation concentrates to potentially address the feasibility of replacement /bypass~     agents/ combined therapy for future bleeding episodes. Patients that will be further treated~     by any regimen potentially suggested (as standard care- not within trial) will be thereafter~     followed , including repeated lab studies to assess the impact of therapy upon hemostasis.~   "
94936|NCT02324504|"~     This study will enroll up to 192 children less than 18 years of age, who will receive~     electrocardiographic guidance for placement of a PICC in addition to radiography done as~     standard care. The investigators will determine the location of the PICC tip from both ECG~     and radiograph, and then measure the degree of correlation between the two methods.~   "
94937|NCT02324491|"~     The purpose of this study is to evaluate efficacy and safety of ZGN-440 (beloranib) in obese~     adult subjects with type 2 diabetes mellitus.~   "
94938|NCT02324478|"~     The autonomic nervous system state (ANSS) and the autonomic nervous system state index~     (ANSSi) - two indices derived from the pulse photo-plethysmography analysis - have been~     recently advocated as a measure of sympathetic activity in the anesthetized patients, but~     their validity has not been yet demonstrated. We will conduct a study aiming to assess if~     ANSS and ANSSi reflect autonomic nervous system modulation on cardiovascular system in~     healthy humans under general anaesthesia.~   "
94939|NCT02324465|"~     The investigators plan to conduct a randomized trial comparing the intubation success rate~     and time of the King Vision Video Laryngoscope to the Glidescope video laryngoscope in order~     to demonstrate the comparability of the devices.~   "
96109|NCT02309164|"~     This study aims to determine the effectiveness of the use of acupuncture in relieving sensory~     and motor symptoms as well as functional impairment and quality of life of patients with~     chemotherapy induced peripheral neuropathy~   "
94940|NCT02324452|"~     In this study it will be determined whether the rate of severe toxicity associated with~     fluoropyrimidine treatment (capecitabine or 5-fluorouracil) can be significantly diminished~     by individualized dosing of fluoropyrimidines based on upfront genotypic assessment of~     dihydropyrimidine dehydrogenase (DPD) deficiency.~      In addition to the genotyping, the DPD phenotype of all patients will be determined by~     measuring the baseline dihydrouracil/uracil (DHU/U) ratio, in order to investigate whether~     phenotype-guided treatment can further improve patient safety. In a subgroup of patients,~     other phenotyping methods will be tested: measuring the plasma levels of uracil after a~     uracil test dose and a uracil breath test after a dose of [2-13C] -labeled uracil. To~     validate these tests, these phenotyping results will be compared with the results of a DPD~     activity assay (which measures DPD enzyme activity in peripheral blood mononuclear cells),~     which is considered the gold standard in measuring DPD phenotype.~   "
94941|NCT02324439|"~     This is a phase 0/phase I feasibility trial to test the hypothesis that flaxseed~     supplementation is an effective maintenance therapy for patients with ovarian cancer who are~     in clinical remission following platinum-based regimens. The investigators further~     hypothesize levels of estrogen metabolites and prostaglandin E2 in this patient population~     will correlate with recurrence of disease, extent of tumor burden, invasion and metastasis.~   "
94942|NCT02324426|"~     Excessive free radical formation and depletion of the brain's primary antioxidant,~     glutathione, are established components of Parkinson's disease (PD) pathophysiology. While~     there is rationale for the therapeutic use of reduced glutathione (GSH) in PD, and even some~     preliminary evidence to suggest the use of GSH can lead to symptomatic improvement, obstacles~     surrounding currently employed delivery methods have hindered the clinical utility of this~     therapy. Intranasal GSH, (in)GSH, is a novel method of glutathione augmentation. The aim of~     this study is to evaluate whether 200 mg of (in)GSH results in measurable changes in brain~     glutathione concentrations, as measured by magnetic resonance spectroscopy (MRS) in 15~     individuals with PD.~   "
94943|NCT02324413|"~     Children who are upset during induction of general anaesthesia are frequently distressed~     postoperatively and are more likely to demonstrate negative behaviour changes.~      This pilot study is a randomised controlled study of clonidine vs placebo during anaesthesia~     to identify whether postoperative behavioural disturbance may be minimised.~   "
94944|NCT02324400|"~     The study is intended to verify the safety and assess the performance of up to 3-days~     treatment protocol with the RenaSense System in ADHF patients.~   "
94945|NCT02324387|"~     The goal of this clinical research study is to compare Tc99m sestamibi molecular breast~     imaging (MBI) scans to mammograms and ultrasounds (the current standard of care) to learn if~     MBI scans can measure if the disease is responding to chemotherapy.~   "
94946|NCT02324374|"~     This will be a feasibility study to evaluate the role of endocytoscopy in classifying~     colorectal polyps in vivo. The primary outcomes will be to determine the key endocytoscopy~     image features of neoplastic and non-neoplastic colorectal polyps. The target population will~     include adult subjects undergoing screening and surveillance colonoscopies.~   "
94947|NCT02324361|"~     To date, approaches that show the most promise for preventing and/or reversing the course of~     childhood obesity involve the delivery of intensive lifestyle interventions within a~     family-based context, emphasizing the necessity of parental involvement and making changes in~     family routines and the home environment. Considering that the current demand for pediatric~     weight management programs far exceed availability, as well as the high attrition rates~     observed in such programs, there is a great need for more accessible and efficient means of~     delivering these interventions to reduce the burden of childhood obesity.~      The goal of this study is to understand whether text messaging and social media platforms can~     be leveraged to address the important issue of childhood obesity by engaging parent/guardians~     in one of these strategies, and whether these strategies produce similar outcomes. No~     existing study has compared these strategies head-to-head, and the investigators believe that~     this project will be instrumental in understanding the determinants of success in these~     strategies and allow us to collect sufficient intelligence to be able to deploy these~     meaningfully to patients as part of usual care.~   "
94948|NCT02324348|"~     It is known that no reflow phenomenon by microvascular obstruction after revascularization in~     STEMI increase infarct size, cardiac remodeling, and a risk of late mortality. Major~     mechanism of microvascular obstruction is distal embolization during procedure. Some~     investigators showed deferred stenting decreased the degree of microvascular obstruction~     compared with immediate stenting in STEMI. The aim of current study is to compare impact of~     immediate stent implantation versus deferred stent implantation on infarct size and~     microvascular perfusion in patients with ST-segment elevation myocardial infarction (STEMI).~   "
94949|NCT02324335|"~     Oral Mucositis (OM) is a painful and debilitating side effect of many of the drug/radiation~     regimens used to treat cancer. This study examines the investigational drug brilacidin and~     its possible application in prevention of oral mucositis in patients undergoing~     chemoradiation for treatment of head and neck cancer.~   "
94950|NCT02324322|"~     The purpose of this research study is to evaluate an exoskeleton device and mobility skills~     in the device.~   "
94951|NCT02324309|"~     The study is designed to compare meal time glucose control associated with BIOD-531, a~     rapidly absorbed concentrated insulin to that associated with Humalog Mix 75/25 and Humulin R~     U-500 in patients with diabetes and severe insulin resistance.~   "
94952|NCT02324296|"~     ABSTRACT Objectives Combination chemotherapy is very active in small cell lung cancer (SCLC),~     although no improvement in overall survival (OS) has been done in the last 25 years , with~     Cisplatin-Etoposide (PE) still considered the world-wide standard, with an average median~     survival of about 7-8 months in patients with extended disease (ED).~      In 1995, a randomized trial of the Hoosier Group in 171 ED patients showed a significant~     advantage in overall survival in patients treated with PEI (Cisplatin, Etoposide and~     Ifosfamide), compared to PE. Despite that, PEI regimen has not become a commonly used regimen~     in SCLC.~      Materials and Methods Here we present a series of 46 consecutive patients (30 males and 16~     females) with SCLC that were treated at our Institution with PEI regimen: Cisplatin 20mg/m2,~     Etoposide 75mg/m2 and Ifosfamide 1200mg/m2, day 1 to 4, every 3 weeks.~      Patients received a total of 219 cycles of chemotherapy, with a mean of 4,7 cycles per~     patient. Median age was 63 (range 59-70); performance status (PS) was 0 in 29 patients (63%),~     1 in 13 patients (28%) and 2 in 4 patients (9%).~   "
94955|NCT02324257|"~     Study BP29541 is a first-in-human, open-label, multi-center, dose-escalation Phase I clinical~     study of single-agent RO6958688 in participants with locally advanced and/or metastatic~     carcinoembryonic antigen (CEA) positive solid tumors who have progressed on standard~     treatment, are intolerant to standard of care (SOC), and/or are non-amenable to SOC. The~     study will be conducted in two parts. Part I of the study will investigate the safety and~     pharmacokinetics of a single dose of RO6958688 in single participant cohorts with dosing~     starting from a minimal anticipated biological effect level dose of 0.05 milligrams (mg) and~     up to a maximum dose of 2.5 mg. Part II will establish the appropriate therapeutic dose based~     on safety, pharmacokinetics, and the maximum tolerated dose (MTD) of RO6958688 for the once~     per week (QW) regimen, every three weeks (Q3W) regimen, and for the step up dosing regimen.~     The overall target sample size is approximately 185 evaluable participants.~   "
94956|NCT02324244|"~     Prospectively assessment of CMV viremia by real-time polymerase chain reaction (PCR) in a~     broad cohort of consecutive immunocompetent adults admitted to a major heart surgery~     intensive care unit (MHS-ICU) with the goal of determining the epidemiology, risk factors,~     and clinical significance of CMV infection.~   "
94957|NCT02324231|"~     In a multi-center open-label cluster-randomized controlled parallel-group multiple crossover~     non-inferiority trial in children and adolescents up to 20 years diagnosed with cancer~     requiring chemotherapy, primarily the safety, and secondarily the efficacy and other~     endpoints, of a high (39.0°C) versus low (38.5°C) temperature limit defining fever (TLDF) for~     the diagnosis of fever in chemotherapy-induced neutropenia (FN) is studied. Safety is~     assessed by the rate of safety relevant events per chemotherapy exposure time, a composite~     endpoint including serious medical complications and bacteremia during FN. Patients are~     repeatedly randomized (cluster: study site) to the high or the low TLDF every month,~     resulting in possible multiple crossovers in one patient. The high TLDF is declared not to be~     inferior regarding safety compared to the low TLDF if non-inferiority of the rate ratio of~     safety relevant events is proven, with a single-sided non-inferiority margin of 1.33,~     applying mixed Poisson regression.~   "
94958|NCT02324218|"~     This study is being conducted to assess the risk of hepatitis B (HepB) diagnosis among~     diabetes mellitus (DM) and non-DM patients of 0-80 years of age with in a large~     population-based cohort in United Kingdom (UK) using data from the CPRD database.~   "
94959|NCT02324205|"~     The aim of this recruitment plan (ADAPT-BX) is to collect image and technical data on both~     digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM), along with~     other subject data including histology results from biopsy specimen examination and cancer~     classification data from initially asymptomatic women referred for biopsy after recall from~     screening and diagnostic work-up. These data will be included in a subsequent and~     prospectively planned pooled analysis described in a separate protocol (ADAPT-BIE) examining~     superiority of DBT to FFDM for breast cancer diagnosis and other clinical performance~     measures.~   "
94960|NCT02324192|"~     Objective: To evaluate the correlation / association between inflammatory ultrasonography~     findings and clinical /functional assessment in symptomatic hand OA interphalangeal joints~     (IP). To evaluate the intra and interobserver reproducibility of ultrasound findings.~      Methods: It was conducted a prospective study in 60 symptomatic hand OA patients. They were~     assessed in six times (T0, T1, T4, T8, T12 and T48 weeks) by blind observers (clinical and~     ultrasonography). The intra and interobserver reproducibility analysis was performed in 25%~     of the sample. Differences were considered as statistically significant when p< 0.05.~   "
94961|NCT02324179|"~     Our objective is to determine whether HIV infected youth have higher level of endothelial~     dysfunction, as measured by Peripheral Arterial Tonometry, when compared to age matched~     healthy controls. The investigators also aim to gather preliminary data on whether~     endothelial Peripheral Arterial Tonometry (endoPAT) measurements of endothelial dysfunction~     are independently associated with HIV and antiretroviral factors, and with markers of~     inflammation and traditional cardiovascular disease risk.~   "
94962|NCT02324166|"~     In retinal surgery, endophthalmitis is a sight-threatening eye infection that could~     complicate patient vision after the operation. At Toronto Western Hospital, for retinal~     surgery (operating at the back of the eye) it is common practice to administer an antibiotic~     (cefazolin) at the end of surgery, to reduce the risk of post-operative endophthalmitis. The~     antibiotic is administered by injection underneath the part of the eye called the~     conjunctiva. However, this antibiotic injection is often associated with high levels of~     post-operative pain. Previous studies have observed a reduction of this pain by injecting an~     anesthetic (lidocaine) in the subconjunctival space before the antibiotic. This study will~     seek to examine whether mixing 2% lidocaine with cefazolin before its injection will reduce~     post-operative pain in the retinal surgery setting.~   "
94963|NCT02324153|"~     This trial focuses on a Phase II randomized masked clinical trial testing the effectiveness~     and safety of peri-operative administration of ramelteon, a melatonin agonist in the~     prevention of postoperative delirium.~   "
94964|NCT02324140|"~     The study investigates inflammatory and antiinflammatory response in patients with severe~     aortic valve stenosis needing either surgical treatment (surgical aortic valve replacement)~     or interventional cardiology treatment (transcatheter aortic valve implantation using the~     transfemoral access route or the transapical access route).~   "
94965|NCT02324127|"~     Detect plasma Hsp90α concentration of liver cancer patients, healthy volunteers, benign liver~     diseases.~   "
94966|NCT02324114|"~     Detect plasma Hsp90α concentration of colorectal cancer patients, healthy volunteers, benign~     colorectal diseases patients.~   "
94967|NCT02324101|"~     Detect plasma Hsp90α concentration of breast cancer patients, healthy volunteers, benign~     breast diseases patients~   "
94968|NCT02324088|"~     To evaluate the benefit of adding docetaxel-5 fluorouracile (D-5FU) regimen after~     pre-operative epirubicin-cyclophosphamide (EC) and loco-regional treatment in inflammatory~     breast cancer (IBC).~   "
94997|NCT02323711|"~     This study is investigating the relative risks and benefits of using two common materials for~     coverage of the skin incision at cesarean delivery. We will perform the first prospective and~     the first randomized controlled trial examining the use of a standard postoperative dressing~     versus skin glue for coverage of the closed skin incision after cesarean delivery. The~     hypothesis is that using skin glue for coverage of the incision will be associated with~     decreased wound complications and increased patient satisfaction.~   "
94969|NCT02324075|"~     Background (brief):~        1. Burden: In low income neighborhoods in Dhaka many households share toilets which are~          often unsanitary and their discharge contaminates the community.~        2. Knowledge gap: Behavior change messages have the potential to make people concerned~          about maintaining shared toilets quality, cleanliness and safety of the facility. There~          are many contributors to poor sanitation in low income neighborhoods in Dhaka but it's~          not clear that the situation can be improved with behavior change or even which specific~          messages to target.~        3. Relevance: Water Sanitation for the Urban Poor (WSUP) is a nongovernmental organization~          working to improve shared sanitation facilities in Dhaka. They are interested in~          developing and evaluating a behavior change program to improve shared sanitation in~          Dhaka and to generate lessons that would be relevant for other low income urban settings~          globally.~      Hypothesis: A behavior change communication intervention can improve the quality and~     cleanliness of sanitation services available to low-income residents of Dhaka.~      Objectives:~        1. To deliver behavior change messages (which target key behaviors influencing the quality~          and cleanliness of shared sanitation facilities) to randomly selected low-income~          communities in Dhaka.~        2. To evaluate the effectiveness of a behavior change communication intervention designed~          to change targeted behaviors related to the quality and cleanliness of shared sanitation~          facilities.~      Methods:~      Local non-governmental organizations will deliver the intervention (behavior change~     communication package) in randomly selected communities. For this study the investigators~     will assess the impact of this intervention on the targeted behaviors using follow-up surveys~     and spot checks.~   "
94970|NCT02324062|"~     This study is about understanding the use of a genetic test (Myriad Genetics myRisk panel)~     that analyzes 25 genes related to different hereditary cancer conditions. The investigators~     hope to learn more about how this type of genetic test is used clinically. The investigators~     also hope to understand more about the experience of individuals and families who undergoing~     this test of genetic testing.~   "
94971|NCT02324049|"~     To evaluate the safety and tolerability of intravenous (IV) administration of SBC 103 in~     subjects with mucopolysaccharidosis III, type B (MPS IIIB, Sanfilippo B) with evaluable signs~     or symptoms of developmental delay.~   "
94972|NCT02324036|"~     The proposed study is a pilot study to gather data on the effectiveness and feasibility of a~     software tool (EMPATHy) to help patients communicate effectively with doctors about problems~     they face with their medication regimens. EMPATHy will be incorporated into an existing~     clinic-based intervention called Coached Care, in which community health workers (CHWs,~     non-professional community members) work as a Coach to patients to help them improve~     engagement and communication during the medical visit.~   "
94973|NCT02324023|"~     Cancer in the colon and rectum represents a global health burden being the most common cancer~     of the digestive tract. It is the second most common cancer in Denmark and only about half of~     the patients survive this diagnosis. Thorough characterization of the tumour preoperatively~     is very important, since it determines if the patient should be treated with chemotherapy~     before operation and, in the future, which operation would be most suitable for the patient.~      Research has shown that endoscopic ultrasound (EUS) is superior to a CT-scan, in determining~     the local growth of the tumour in rectal cancer. Today, a CT-scan is the image modality of~     choice, and is used in all Danish hospitals when it comes to colon cancer. Hopefully, the~     investigators can apply EUS in colon cancer patients and thereby alter our diagnostic~     approach, towards a quicker and safer way to determine which treatment the investigators~     should offer the patient.~      With the screening programme for colorectal cancer in Denmark the investigators will find~     more and more cases of colorectal cancers, especially in the early stages, before symptoms~     begin. These small tumours put doctors in several dilemmas concerning the strategy of~     treatment. Even today, the investigators are very reluctant in offering large-scale~     operations to elderly and fragile patients who have been diagnosed with cancer in the rectum.~     Instead, local endoscopic operations are performed in selected patients. This approach has~     not yet been tried in early colonic cancers. However, it might turn out that local,~     endoscopic surgery will show to be beneficial for patients with colon cancers and maybe even~     decrease morbidity, mortality and the regenerative period after surgery.~      The aim of this PhD-project is to investigate the utility of the EUS-method in characterizing~     tumours in the colon and in investigating the blood flow in the tumour.~   "
94974|NCT02324010|"~     The purpose of this study is to evaluate the acute effects of sitagliptin on postprandial~     glycemia, incretin hormones and blood pressure, and the relationship to gastric emptying,~     after a mashed potato meal in patients with type 2 diabetes.~   "
94975|NCT02323997|"~     This study will investigate the types of HPV in samples from women with cervical pre-cancer~     and cancer and gather information to help investigate the impact of HPV vaccination in~     Switzerland.~   "
94976|NCT02323984|"~     Identification of specific circulating microRNAs and microemboli formation (diagnosed by TC~     Doppler) in both delirious groups and nondelirious group will be our primary target. Delirium~     assessment through standardized questionnaires will be done at baseline (day of the surgery -~     pre operatory), immediately after surgery (in post anesthesia care unit) and then every 12~     hours in Day 1 and Day2 after surgery. The investigators will use linear mixed models to~     describe the change patterns overtime, and compare differences at each time point.~     Inflammatory biomarkers will be explored overtime as well. The investigators will also~     explore age effect on cognitive function - cognitive reserve - based on the score of the~     cognitive test administered at baseline.~   "
94977|NCT02323971|"~     Dual antiplatelet therapy consisting in aspirin and clopidogrel is the cornerstone of the~     treatment of the prevention of the thrombotic events in patients with coronary artery disease~     (CAD), showing a reduction in adverse events.~   "
94978|NCT02323958|"~     This study is to observe whether transcutaneous electrical stimulation at specific acupoints~     could improve the quality of emergence in patients undergoing robotic laparoscopic~     gynecologic surgery.~   "
94979|NCT02323945|"~     Accumulating evidence suggests that repeatedly breathing low oxygen levels for brief periods~     (termed intermittent hypoxia) is a safe and effective treatment strategy to promote~     meaningful functional recovery in persons with chronic spinal cord injury (SCI). The goal of~     the study is to understand the mechanisms by which intermittent hypoxia enhances motor~     function and spinal plasticity (ability of the nervous system to strengthen neural pathways~     based on new experiences) following SCI.~   "
94980|NCT02323932|"~     The purpose of this study is to evaluate the benefit of bimodal hearing and bilateral~     cochlear implant hearing in comparison to unilateral cochlear implant hearing in the~     perception of speech intonation.~   "
94994|NCT02323750|"~     TransitionCHF aims to recruit a unique cohort of patients with asymptomatic left ventricular~     dysfunction (NYHA I) to study the progression to symptomatic (>NYHA I) HF and to identify~     parameters/ biomarkers promoting and predicting the individual risk of transition. Results~     from TransitionCHF Cohort Study will inform and refine current treatment guidelines. The~     implementation of common patient data sets and biobanking standards will enable data and~     biomaterial sharing with other DZHK study groups. This study will set the standard for a~     unique DZHK heart failure database and Biobank for innovative preclinical and clinical~     trials.~   "
94995|NCT02323737|"~     Patients with untreated extensive-stage small cell lung cancer(SCLC) were randomly assigned~     to receive either irinotecan/cisplatin (IP) or etoposide/cisplatin(EP), The association of~     efficacy and toxicity of IP regimen was analyzed.~   "
94996|NCT02323724|"~     To determine the improvement in diagnosis of papillary carcinoma by detecting mutation V600E~     BRAF in retrospective cases with inconclusive cytologic diagnosis (categories III, IV and V~     of Bethesda System)~   "
94981|NCT02323919|"~     Using a randomized clinical trial with 3 groups, the investigators will conduct a~     head-to-head evaluation of two different theoretically-based interventions, SystemCHANGE and~     CHANGE+, as compared to Usual Care to improve the adoption and maintenance of exercise in~     older cardiac patients. SystemCHANGE, a novel intervention that focuses on environmental~     change uses System Improvement strategies to increase exercise, will be compared to CHANGE+~     (an intervention based contemporary cognitive behavioral strategies). Study questions are:~     (1) Is there a difference between SystemCHANGE, CHANGE+ and Usual Care in exercise adoption~     when controlling for covariates (age, race, functional capacity, body fat, co-morbidity,~     muscle or joint pain, exercise experience, home and neighborhood environment, and~     depression), for individuals following a cardiac rehabilitation program (CRP)? (2) Is there a~     difference between SystemCHANGE, CHANGE+, and Usual Care in exercise maintenance when~     controlling for covariates? (3) Do system changes, social support for exercise,~     problem-solving skills, motivation, health beliefs, and exercise self-efficacy mediate the~     effects of SystemCHANGE, CHANGE+, or Usual Care on exercise adoption? (4) Do system changes,~     social support for exercise, problem-solving skills, motivation, health beliefs, and exercise~     self-efficacy mediate the effects of SystemCHANGE, CHANGE+ and CHANGE+ interventions in terms~     of health care spending, labor force participation and earnings, and household productivity?~      Older persons (N=420) recovering from cardiac events will be randomly assigned to the three~     groups. Measures of exercise adoption and maintenance (# of metabolic equivalents {METS}~     expended, and whether or not a subject remains exercising) will be taken for 1 year after~     completion of a CRP using heart rate wristwatch monitors, exercise diaries, and 7-Day Recall~     Survey. The effect of covariates also will be assessed. Mechanisms by which the interventions~     achieve their effects will be determined. Multivariate analyses will examine and compare the~     effects of the interventions over time. A cost-effectiveness analysis also will be conducted.~   "
94982|NCT02323906|"~     CC-122-HCC-001 is a Phase 1b dose escalation and expansion clinical study of CC-122 in~     combination with sorafenib for subjects with unresectable HCC who have received no prior~     systemic therapy for HCC. The dose escalation phase of the study will explore several dose~     levels of CC-122 in combination with sorafenib, followed by an expansion part of the study~     using the optimal combination dose regimen.~   "
94983|NCT02323893|"~     The goal of this study is to visualize biodistribution of a PET tracer called [18F]F-AraG~     through time in healthy human volunteers.~   "
94984|NCT02323880|"~     This phase I trial studies the side effects and best dose of selinexor in treating younger~     patients with solid tumors or high-grade gliomas that have come back (recurred) or do not~     respond to treatment (refractory). Drugs used in chemotherapy, such as selinexor, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading.~   "
94985|NCT02323867|"~     This is a single arm pilot study for patients using α/β T cell-depleted PSCT in with~     alternative donor sources with hematologic malignancies receiving alternative donor~     (unrelated or partially matched related) mobilized peripheral stem cells (PSCs) using the~     CliniMACS system for T cell depletion plus CD19+ B cell depletion to determine efficacy as~     determined by engraftment and GVHD, and one year leukemia free survival.~   "
94986|NCT02323854|"~     Post market prospective, non-randomized, single-arm, multicenter study, designed to~     demonstrate dose response of an ablation system using a percutaneous approach in patients~     with primary, metastatic, or recurrent primary lung tumors.~   "
94987|NCT02323841|"~     Currently conservative treatment for patients of childbearing affected by cervical cancer is~     reserved for women with FIGO stage IA2 - IB1 with tumor size less than 2 cm . The~     trachelectomy and the cone biopsy with pelvic lymphadenectomy are the choice for these~     patients wishing to preserve their reproductive function.~      In this context , recently literature show the results about the use of neo-adjuvant~     chemotherapy about the reduction of tumor volume and therefore the magnitude of the~     subsequent surgical treatment (including patients with tumors larger than 2 cm ). So it~     becomes crucial a prospective analysis on the possibility to include in this type of~     treatment patients with stage IB1 and IIA1 with tumor size greater than 2 cm ( up to 4 cm ) .~      The current study , in fact , would like to do a prospective evaluation on the advantages of~     neo-adjuvant chemotherapy in the possibility of broadening the inclusion criteria to~     conservative treatment in women , suffering from cervical cancer, stage IB1 and IIA1 ( with~     tumor volume between 2 and 4 cm) and wishing to preserve their reproductive function.~   "
94988|NCT02323828|"~     Evaluation of the effect of ingestion of high RS-cookies prepared from high amylose corn~     starch on food intake and appetite control of a cohort of healthy students. Cookies were~     prepared with increasing RS content and were fed to 18 healthy students in a blind trial~     versus a placebo.~      Parameters of interest were: short and long time intake (ad libitum test meal and 12 h diet~     diaries, respectively).~   "
94989|NCT02323815|"~     Globally, child undernutrition is the underlying cause for 3.1 million deaths of children~     younger than 5 years. 18.7 million children under five years of age suffer from severe acute~     malnutrition (SAM) and an additional 33 million children suffer from moderate acute~     malnutrition, and are at risk of developing SAM~      In Sub-Saharan Africa, there is often poor integration between programs to treat child acute~     malnutrition and programs that focus on the prevention of acute and chronic undernutrition -~     resulting in many missed opportunities for using prevention platforms to screen and refer SAM~     children, or for using screening and referral platforms to provide prevention services.~      This project will address two critical gaps related to the integration of preventive and~     treatment programs: 1) screening and treatment of MAM/SAM have not yet been systematically~     integrated into routine health-center visits or mainstreamed into community outreach~     programs; and 2) screening programs do not offer any preventive services for those children~     found not to be suffering from MAM/SAM at the time of screening; mothers of children~     identified as non-MAM/SAM case are usually sent home without receiving any health or~     nutrition inputs and as a result, may fail to come back for screening because they do not see~     any tangible benefit associated with their participation in the screening. This project will~     specifically address these gaps by assessing the effect of an integrated approach consisting~     of higher screening coverage and preventive Behavior Change Communication (BCC) +~     Small-Quantity Lipid-based Nutrient supplementation (SQ-LNS) on both prevention and treatment~     of child undernutrition.~   "
94990|NCT02323802|"~     Results after interventions on lifestyle in the secondary prevention of ischemic heart~     disease are not always consistent, and the Guidelines multidisciplinary measures aren't~     easily achievable.~      Therefore, the purpose of this research project is the identification of an interventional~     approach to effective secondary prevention and realistic feasibility, in a field of~     multifactorial risk. The study is open to patients who totaled a double chronic disease,~     obesity/overweight and coronary heart disease, and who experienced a first event of ischemic~     cardiac infarction (AMI). The aim is to evaluate the effectiveness of a group educational~     intervention in a sample of overweight and obese patients (BMI > 24.9) incurred in a first~     episode of acute myocardial infarction (non-STEMI and STEMI), comparing with the classic~     approach of prescriptive diet therapy.~   "
94998|NCT02323698|"~     Accumulating evidence suggests that repeatedly breathing low oxygen levels for brief periods~     (termed intermittent hypoxia) is a safe and effective treatment strategy to promote~     meaningful functional recovery in persons with chronic spinal cord injury (SCI). The goal of~     the study is to understand how caffeine may augment the effects of intermittent hypoxia on~     motor function and spinal plasticity (ability of the nervous system to strengthen neural~     pathways based on new experiences) following SCI.~   "
94999|NCT02323685|"~     Safety and effect of SANGUINATE on patients DCI following SAH.~   "
95000|NCT02323672|"~     45 individuals were subdivided into 3 groups, 15 patients with oral premalignant lesions, 15~     patients with oral malignant lesions and 15 control individuals. Levels of chemerin and MMP-9~     were evaluated in serum and saliva of these subjects utilizing the ELISA technique.~   "
95001|NCT02323659|"~     Comparison of methotrexate versus interferon-alfa 2b on efficacy, safety and quality of life~     in patients with primary cutaneous T-cell lymphomas after failure of topical or phototherapy~     treatment.~   "
95002|NCT02323646|"~     The primary objective of this study is to determine the safety and efficacy of two vaginal~     doses of Proellex administered for up to 2 courses of treatment (18 weeks each), each~     separated by an Off-Drug Interval (ODI), to premenopausal women with symptomatic uterine~     fibroids.~   "
95003|NCT02323633|"~     Children with ADHD display a certain brainwave profile which might be different to that of a~     child who does not have ADHD. Treatment with tPCS (transcranial pulsed current stimulation)~     has shown that this brainwave profile could possibly be altered to more closely resemble a~     brainwave profile of a child who does not have ADHD. Researchers believe that by changing~     this brainwave profile it might lessen symptoms of ADHD.~      tPCS is a name used to describe the type of current this device produces. It involves~     randomly (in no specific pattern) produced pulses of current at different times that the~     brain picks up. These pulses of low current stimulate the brain in a certain way and affect~     the brainwave activity.~      Treatment is given by applying a low frequency current using small electrodes clipped to the~     earlobes. The current comes from an external battery source. The pulses of current generated~     by this device stimulate certain parts of the brain which result in a possible increased~     control of attention and behaviour. This treatment has already been proven to be safe and~     will not hurt your child.~      Due to these specific parts of the brain being stimulated, and the positive results of~     previous research, it seems possible to control certain functions in children suffering from~     inattention and hyperactivity.~      The idea of using tPCS stimulation as a possible way for helping children with confirmed ADHD~     opens a new window to future research. The final goal of this device and research is to offer~     a safe, non-invasive (conservative treatment that does not require piercing into the body or~     the removal of tissue) treatment that can be used on a long-term basis and shows a clear~     improvement of ADHD symptoms for children and even adults with ADHD.~   "
95004|NCT02323620|"~     This is multicentre, randomised open-label, controlled, parallel-group phase III study. Its~     aim is to demonstrate that a triple intracoronary infusion of autologous bone marrow-derived~     mononuclear cells in addition to state of the art treatment is safe and reduces all-cause~     mortality in patients with reduced left ventricular ejection fraction (≤45%) after successful~     reperfusion for acute myocardial infarction when compared to a control group of patients~     undergoing best medical care.~   "
95005|NCT02323607|"~     This phase I trial studies the side effects and best dose of pacritinib when given together~     with chemotherapy in treating patients with acute myeloid leukemia that have an abnormal~     change (mutation) in the fms-related tyrosine kinase 3 (FLT3) gene. Pacritinib may stop the~     growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as cytarabine, daunorubicin hydrochloride, and decitabine, work in~     different ways to stop the growth of cancer cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Giving pacritinib and chemotherapy~     may be a better treatment for acute myeloid leukemia with FLT3 mutations.~   "
95006|NCT02323594|"~     Grps 1, 2, 3 This study will be testing the performance of ASV and DCV pediatric chewable~     tablets.~      Grp #4 The purpose of this group is to support the marketing authorization of a DCV 90-mg~     tablet~   "
95007|NCT02323581|"~     Prospective, nonrandomized, single-center, single-arm feasibility and safety study to assess~     the feasibility and safety of endovascular stent-graft implantation using a standard~     configuration branched and fenestrated stent graft (TAAA device) or physician-specified~     branched and fenestrated stent grafts (Physician-Specified TAAA Devices) for treatment of~     thoracoabdominal aortic aneurysms (TAAA) involving the mesenteric and renal arteries in~     patients at high risk for open surgery.~   "
95008|NCT02323568|"~     This project is part of a large multicenter multidisciplinary program that will thoroughly~     explore the needs and difficulties of patients with BCR as well as those involved in their~     care. The results of this research program will propose recommendations for better structure~     and understand the follow up of these patients.~      From the limited data in the literature, the long-term remission in patients with ovarian~     cancer reported a significant and persistent fatigue, poor QoL, disorders of sexuality as~     well as somatic and mental illness; consumption is also a medical records for these patients.~      In this context, our team has initiated a large case-control study to assess fatigue~     (identified major problem in the long-term remission in patients with ovarian cancer), QoL~     and rehabilitation of patients in remission from an epithelial ovarian cancer (regardless of~     the stage of cancer at diagnosis, early or advanced) 3 years after the initial treatment,~     compared with women of the same age without ovarian cancer or serious chronic disease , from~     the general population.~      Patients and controls complement standardized and validated self-administered questionnaire~     (part 1). This study investigated 215 patients in long remission from ovarian cancer compared~     to 215 women of the same age without cancer. Recruitment of patients is currently underway,~     in close collaboration with teams from the Group GINECO very involved in this project.~      Following this step, an additional component is planned: it is to offer patients who~     participated in part 1, a specific gynecological consultation to assess in detail the effects~     of the treatments in order to better meet the needs of patients .dropoff window~   "
96122|NCT02308995|"~     The aim of this randomized controlled trial is to compare operative data and early~     postoperative outcomes of laparoscopic excision of endometrioma using barbed sutures with~     those of laparoscopic excision of endometrioma using conventional sutures.~   "
95009|NCT02323555|"~     A prescription of injectable anticancer therapy requires the collection of medical data~     (interview and physical examination) and often allied (laboratory tests). This requirement is~     made on the day of the arrival of the patient to not prepare these treatments incorrectly.~      After receiving the prescription of treatment, it will take about 1 hour to prepare for~     pharmacy and more in times of high activity, to provide the day hospital pockets treatment,~     incompressible time when the patient waits to have his treatment.~      A process has been selected (Optima) to anticipate prescribing injectable cancer treatments~     and their manufacturing to reduce patient waiting times on the day of his coming François~     BaclesseCentre day hospital.~   "
95010|NCT02323542|"~     The present study aims at investigating the effect of ingesting 2 cereal products differing~     by their SDS content on the kinetics of glucose in healthy volunteers.~   "
95011|NCT02323529|"~     The purpose of this study is to look at the steady-state serum concentrations of nitisinone~     when switching from twice daily and once daily dosing.~   "
95012|NCT02323516|"~     The mechanisms of action of the side effects associated with targeted therapies are still~     poorly understood. He was found in patients treated with gefitinib, increased levels of~     thromboxane B2 and P-selectin Thromboxane B2 is the result of the hydrolysis of thromboxane~     A2, which is itself obtained from Prostaglandin H2 under the action of the thromboxane~     synthetase. The thromboxane A2 is produced by platelets and the active pro-thrombotic~     properties as follows: stimulation of platelets and activation of other increased platelet~     aggregation.~      The selectins are cell adhesion proteins with a role in the adhesion phenomena. P-selectin is~     expressed by platelets and endothelial cells.~      The demonstration of increased plasma levels of thromboxane B2 and P-selectin leaves suggest~     a role of platelet activation in the occurrence of side effects associated with targeted~     therapies.~      Kanazawa's study was conducted in 39 Japanese patients, trying to assess the value of~     low-dose acetylsalicylic acid or 100mg per day, that is to say, anti-aggrégantes doses, the~     occurrence rash and diarrhea induced by gefitinib.~      In this study, the group of patients treated with acetylsalicylic acid presented a lower rate~     of side effects significantly, 58.3% versus 77.8%. The frequency of diarrhea was 18.5% (or 5~     patients) in the standard group versus 0% in the group with acetylsalicylic acid. Similarly,~     it was found a reduction in the occurrence of skin rash, 33.3% or 4 patients in the~     acetylsalicylic acid group versus 74.1% s, 20 patients in the standard group. Finally, in~     this study, it was not revealed significant differences in terms of response to treatment~     with gefitinib (37% in the standard group versus 33% in the group treated with aspirin~     patient) It does not exist in our knowledge of prospective data evaluating the effect of~     acetylsalicylic acid on the reduction of side effects associated with targeted in a~     population of patients of Caucasian-type treatment.~   "
95013|NCT02323503|"~     Cardiac resynchronization therapy (CRT) has been shown to reduce heart failure (HF),~     hospitalizations and death in patients with left ventricular ejection fraction (LVEF) <35%~     and wide QRS. CRT provides electromechanical resynchronization and improves LV systolic~     function. The induced LV reverse remodeling or near normalization in LVEF to ≥45% is~     associated with a significant reduction in the risk of subsequent life-threatening~     ventricular tachyarrhythmias (VTA). And at the time of replacement, the need for~     defibrillator back-up after an event-free first CRT-D service-life for patients with improved~     LVEF is a controversy question.~      80% of Implantable Cardioverter Defibrillator (ICD) patients implanted for primary prevention~     do not experience VTA during the life-time of their first device.~      So, regarding patients implanted with a CRT-D for primary prevention at the time of first~     implantation, the question is will they experience VTA after their device replacement by~     another CRT-D.~   "
95014|NCT02323490|"~     This study will compare meniscal healing augmented or without augmentation with bone marrow~     stimulation techniques The assessments will include validated, disease specific, patient~     oriented outcome measures, second look arthroscopy during second step ACL reconstruction.~     Results of this study will help ascertain whether microfractures improve meniscal healing~     rates.~   "
95015|NCT02323477|"~     The purpose of this phase 1/2 clinical trial is to evaluate the efficacy and safety of~     allogeneic human umbilical cordstroma derived multipotent stem cells (hUCS-MSCs) in~     myocardial infarction (MI). All subjects will be taken into the bypass coronary surgery prior~     to the cell administration. This 2-year study comprise three independent groups, where the~     first group (n=20) will take no cells, second group will take autologous BM-MNCs (n=20), and~     third group (n=39) will be receiving allogeneic hUCS-MSCs. In all transplantations cells will~     be administered to the approximately 10 peri-infarct areas at one time. The infarct zone will~     be determined by the MR, SPECT and PET imaging. Only male subjects between 30-80 years of~     age. The efficiency of the therapy will be evaluated according to the parameters measured by~     MR, SPECT, and Echocardiography. All subject were taken into those measurements prior and 6,~     12, 18 and 24 months after the operation.~   "
95016|NCT02323464|"~     300 patients with colorectal cancer will be investigated before surgery and 60 of them will~     also be investigated in the same manner after surgery. Investigations will include~     polysomonographic sleep apnea recordings during one night, lung function measurements, blood~     gas samples and a questionnaire, but only before surgery including questions on sleep, sleep~     apnea, lung disorders.~      Outcome: side effects of surgery and mortality rate, association with cancer type.~      Prevalence of sleep apnea, sleep quality, hypoxemia and lung function before and after~     surgery.~   "
95017|NCT02323451|"~     This study evaluates the safety and efficacy of investigational products in the treatment of~     knee Osteoarthritis. Half of participants will receive medical chitosan, while the other half~     will receive sodium hyaluronate.~   "
95018|NCT02323438|"~     A single-center, randomized, controlled, switching, open-label, parallel cohort study.~     Smoking subjects will be confined to a clinic for 9 days. During their stay, baseline~     assessments during ad libitum smoking will occur for the first 3 days. Following baseline,~     subjects will be switched to either an Electronic Cigarette or Nicotine Gum, and post-product~     switch assessments will occur for 6 days.~   "
95019|NCT02323425|"~     The purpose of this study is to evaluate the protective effects of upper limb ischemic~     postconditioning on collateral circulationin young symptomatic intracranial atherosclerosis~     and the baseline characteristics of trial participants, as an open, randomized controlled,~     prospective controlled trial.~   "
95066|NCT02322801|"~     This multi-center, observational, retrospective-prospective cohort study will investigate the~     safety of rituximab (MabThera) by collecting data from daily clinical practice on the use of~     rituximab and its relative clinical impact, particularly with regard to adverse events. Data~     from each patient will be collected over 24 months after enrolment in the study. Target~     sample size is up to 325 patients.~   "
95067|NCT02322788|"~     A randomised, double-blind, double-dummy, multi-site, phase III, single dose, 4-way~     cross-over pharmacodynamic study evaluating the efficacy of Bricanyl Turbuhaler M3 compared~     to Bricanyl Turbuhaler M2 by studying the protective effect on methacholine induced~     bronchoconstriction in patients with stable, mild to moderate asthma~   "
95020|NCT02323412|"~     Low-back pain (LBP) is the single leading cause for disability worldwide, affects all age~     groups and has increased from 58 million years lived with disability (YLDs) in 1990 to 83~     million YLDs in 2010. The burden is accordingly substantially higher than previously~     assessed, causing activity limitation and work absence with subsequently enormous economic~     burden. Norwegian expenses reach at least NOK 24 billions annually whereof a substantial part~     is hospital costs. The research project responds to this challenge and aim to conduct a~     multicenter randomized placebo-controlled trial, complemented by a study of epigenetic and~     molecular biomarkers, to re-examine the finding of a recent randomized controlled trial that~     antibiotic treatment can cure patients with chronic low back pain (LBP), a former disc~     herniation and present Modic Changes (MCs). The hypothesis is that MCs is caused by low~     virulent anaerobic organisms in the disc. Investigators also want to add important new~     knowledge to the research field beyond the only former RCT by broadening the inclusion~     criteria to include both patients with type I and type II MCs, improving the MRI assessment~     of MCs, further clarifying the pathogenesis of MCs by studying genetic variability, gene and~     protein expression of inflammatory biomarkers, and conducting health economic analysis.~   "
95021|NCT02323399|"~     The primary objective of this study is to evaluate the dose effect of Phenylephrine~     Hydrochloride Injection on the treatment of clinically relevant decreased blood pressure in~     the pediatric population, ≥12 to 16 year old patients undergoing general and neuraxial~     anesthesia.~      The secondary objectives are to describe changes in blood pressure and heart rate, time to~     onset and to maximal response, and the duration of response; to assess the safety of the~     product in this population; and to characterize the pharmacokinetics of phenylephrine~     hydrochloride.~   "
95022|NCT02323386|"~     Background: Across the European Union there are 535,000 Total Knee Arthroplasty (TKA)per~     year. Statistics indicate that for patients over 60 year old approximately one out of 20 will~     require corrective reoperations within 10 years after surgery. However, for patients younger~     than 60 years, approximately one out of 10 will require revision total knee arthroplasty~     within 10 years of surgery. As the number of younger patients is increasing, there has been a~     shift in focus in total Knee Replacement (TKR) outcome, with post-operative function and~     implant longevity being the important issues for quality of patient care. Furthermore, it has~     been reported that up to 25% of patients are not satisfied with the functional results of~     their TKA. In vivo the gold standard for obtaining reliable 3D measurements is RSA. However~     these are often static, because of even most advanced x-ray film exchanger limit the number~     of pictures taken to less than 10 per second. Our dynamic RSA technique allows producing real~     time x-ray video of TKA in weight-bearing (WB) conditions with active muscle contraction.~      The purpose of this study is to investigate the effect of a new implant design on the~     post-operative active knee kinematics, focusing on mid-flexion instability of the joint. A~     prospective randomized study will be performed on a new implant: the DePuy ATTUNETM~     fixed-bearing (FB) posterior-stabilized (PS) knee prosthesis.~   "
95023|NCT02323373|"~     This clinical trial investigated two different routes of administration of tranexamic acid in~     total knee arthroplasty: topical compared to intravenous.~   "
95024|NCT02323360|"~     The trial is a multicentre, prospective, randomised controlled, unblinded, parallel-group~     superiority trial of SBRT versus standard TAE/TACE for the curative treatment of inoperable~     HCC treated with a TAE/TACE incomplete cycle.~   "
95025|NCT02323347|"~     At which deleterious cut off value of progesterone on day of HCG (P-hCG) in our IVF program~     should fresh embryo transfer (ET) be cancelled?~   "
95026|NCT02323334|"~     This study involves single and multiple doses of LY3202626 and will evaluate the effects of~     LY3202626 on the body. There will be 4 parts to this study. In Parts A and B, single~     increasing doses of LY3202626 will be given in capsule form. Part A will also include~     itraconazole given orally as a solution. Part A will last approximately 8-12 weeks. Part B~     will last approximately 5-6 weeks. In Parts C and D, participants will be dosed multiple days~     with the study drug. Part C will last approximately 11-14 weeks. Part D will last~     approximately 11-14 weeks and participants must have Alzheimer's Disease. Participants may~     only enroll in one part.~   "
95027|NCT02323321|"~     To evaluate the effectiveness of the OCS™ Heart to recruit, preserve and assess donor hearts~     that may not meet current standard donor heart acceptance criteria (as identified above) for~     transplantation to potentially improve donor heart utilization for transplantation~   "
95028|NCT02323308|"~     The aim of study is to describe the clinical, immunological, serological, virological and~     therapeutic characteristics of HIV+ patients harboring isolated anti-HBc profile and to~     assess the response to vaccination in these patients.~   "
95029|NCT02323295|"~     This study is designed to characterize the effects of high energy radiation on bone~     breakdown, with a specific interest in reducing the rate of sacral fractures. Although~     radiation is very important in managing tumors, it is related to complications such as bone~     fractures. In this research study, the investigators are looking to determine changes in~     blood markers, bone density, and bone structure following radiation and to better understand~     the reason for these changes.~   "
95030|NCT02323282|"~     To determine the median effective concentration of ropivacaine hydrochloride for~     ultrasound-guided supraclavicular brachial plexus block. The result can provide reference for~     choosing appropriate drug concentration in clinical anesthesia.~   "
95031|NCT02323269|"~     The primary objective of the study is to estimate the annualized relapse rate (ARR) over a~     12-month period in patients with Relapsing-Remitting Multiple Sclerosis (RRMS) who are~     treated with dimethyl fumarate (DMF) as their initial therapy (treatment-naïve), or switching~     from interferon (IFN) or glatiramer acetate (GA) (after suboptimal response defined as~     suboptimal efficacy, intolerance, or poor adherence to IFN or GA), as determined by the~     Prescribing Physician. The secondary objectives of this study in this study population are:~     To assess the impact of DMF over a 12 month period on patient reported outcomes (PROs) and~     health economic related outcomes; and to evaluate additional clinical outcomes at Month 12.~   "
95032|NCT02323256|"~     This study aims at investigating new automatic fitting techniques for cochlear implant~     patients based on objective measures. For this reason, the evolution of these~     neurophysiological measures, expressing the encoding of pure tones and speech, will be~     characterized in cochlear implanted patients as a function of post-implantation time and will~     be compared to those of normal hearing subjects. Moreover, the effect of auditory training~     with new tools based on serious games will be assessed.~   "
95033|NCT02323243|"~     Detrusor striated sphincter dyssynergia (DSSD) is defined as the persistence or increasing of~     the striated sphincter activity during voiding and characterizes the spinal cord injuries~     located under the protuberance. The standard treatment for DSSD is medical, either~     pharmacological or by clean intermittent self-catheterisation (CISC). Some patients are~     unable to perform CISC and require alternative surgical techniques such as external~     sphincterotomy which is invasive, irreversible and with no adjustment period for the patient.~      Urethral stents have been developed as an alternative to surgical sphincterotomy. Temporary~     stents provide a non-definitive treatment, especially for evolutionary pathologies, for~     patients refusing a destructive surgery (psychosocial impact), or for patients having not~     defined yet their therapeutic preference. The Allium company has developed the  Bulbar~     Urethral Stent  (BUS) system, which advantages are the possibility to perform the procedure~     under local anesthesia and to remove more easily the stent, with similar performances~     compared to the other devices. In order to quantify the interest of the BUS system, the~     investigators propose to perform a prospective study aimed at describing its technical and~     clinical results in terms of efficacy and safety.~   "
95034|NCT02323230|"~     This phase 2 study is designed to assess the efficacy and safety of DPX-Survivac plus low~     dose cyclophosphamide in subjects with recurrent diffuse large B-cell lymphoma (DLBCL) who~     are not eligible for transplant.~   "
95035|NCT02323217|"~     The imdazoline2 binding site (I2BS) is known to reside inside astrocytes. Changes in the~     numbers of I2BS in post mortem tissue has implicated them in a range of psychiatric~     conditions such as depression and addiction, along with neurodegenerative disorders such as~     Alzheimer's disease and Huntington's chorea. Preclinical studies have also demonstrated~     functional interactions with the opioid system, where I2BS ligands have been shown to affect~     tolerance to morphine and alleviate some of the morphine withdrawal syndrome in rats.~     Recently the I2BS and I2BS ligands have been shown to have some interesting analgesic effects~     in different models of pain and a novel I2BS ligand, CR4056, is currently undergoing Phase II~     clinical trials as a novel treatment for neuropathic pain and acute non- specific pain~     states.~      The location of I2BS on astrocytic glial cells and the possibility that they may in some way~     regulate glial fibrillary acidic protein have led to increased interest into the role of I2BS~     and I2BS ligands in conditions characterised by marked gliosis. The number of I2BS has been~     shown to increase in Alzheimer's disease post mortem, and it has also been suggested that~     I2BS may be a marker for the severity and malignancy of human glioblastomas.~      The lack of suitable imaging tools for the I2BS has meant that information regarding the~     number and distribution of I2BS in the brain has come from preclinical species and in vitro~     post-mortem studies. The recent development of [11C]BU99008 as a suitable PET ligand to~     quantify I2BS in vivo, enables the direct quantification of I2BS availability and regional~     distribution in the living human brain. In this study the investigators plan to utilise~     [11C]BU99008 to quantify the regional brain availability of I2BS in the human brain in vivo~     using PET.~   "
95036|NCT02323204|"~     Children presenting to the University of Iowa Health Care System (UIHC), Blank Children's~     Hospital (Blank), Children's Hospital of Minneapolis, and Kansas City Mercy Children's~     Hospital with an injury resulting in admission will be the sample population. A child will be~     included if they are 10-17 years old with an unintentional injury. Consenting children and~     their parents will be asked to complete a series of four questionnaires: before hospital~     discharge, at 1-month post discharge, 3-months and 6-months post discharge. The parent-child~     dyads will be randomized (1:1) to receive 1) training in Link for Injured Kids or 2) Trauma~     Education. The survey completed in the hospital will be a paper survey or online via an iPad,~     and follow-up surveys can be completed on paper or online.~      Aim #1: Assess the feasibility of Link for Injured Kids through qualitative research with~     parents and providers of previously injured children from UI Children's Hospital.~      Aim #2: Through a randomized trial, determine the range of potential psychosocial and~     behavioral health indicators possibly impacted by Link for Injured Kids. This will identify~     the types of outcomes which could include post-traumatic stress disorder (PTSD), depression,~     nonspecific distress, quality of life, absenteeism, school performance, coping skills,~     communication skills, and access to mental health.~   "
95037|NCT02323191|"~     This Phase 1, open-label, multicenter, global study will evaluate the safety,~     pharmacokinetics, and activity of emactuzumab and atezolizumab administered in combination in~     participants with selected locally advanced or metastatic solid tumors that are not amenable~     to standard treatment.~      Participants who receive emactuzumab and atezolizumab will continue to receive study drug as~     long as they experience clinical benefit in the opinion of the investigator or until~     unacceptable toxicity or symptomatic deterioration attributed to disease progression as~     determined by the investigator after an integrated assessment of radiographic data, biopsy~     results (if available), and clinical status, or withdrawal of consent.~   "
95038|NCT02323178|"~     Treatment of patients with chronic myelomonocytic leukemia (CMML) and thrombocytopenia.~   "
95039|NCT02323165|"~     The primary aim is to determine if this new technique will detect and identify bacteria in~     the blood sooner than standard blood cultures or identify patients who may be septic without~     growing bacteria in their cultures. These will be correlated with the data collected from~     medical records on presumed sepsis. These results will be linked to data concerning infection~     that will be available as part of routine care including blood counts and other laboratory~     values that would be part of the routine medical care such as a white blood cell count. The~     earlier the bacteria are identified and the appropriate antimicrobials are administered the~     better the patient outcome.~   "
95068|NCT02322775|"~     The purpose of this trial is to confirm the safety and clinical benefit of benralizumab~     administration in asthma patients with mild to moderate persistent asthma in order to gain an~     understanding of the benefit/risk of benralizumab across the spectrum of asthma disease.~   "
95069|NCT02322762|"~     DISCOVER is a Non Interventional Study study to describe the disease management patterns and~     clinical evolution over three years in type 2 diabetes mellitus patients initiating a second~     line anti-diabetic treatment.~   "
95070|NCT02322749|"~     A Study to assess, against a reference selumetinib capsule, if the drug levels of a variant~     of selumetinib capsule are comparable, and to assess how drug levels differed in another~     variant of Selumetinib in Healthy Male Volunteers.~   "
95040|NCT02323152|"~     Postpartum depression is a disease with a prevalence of 10% which has not only deleterious~     consequences for the mother but also for the baby and can delay the physical, social and~     cognitive development of the baby. Therefore we consider very important to prevent this~     disease as from the centers of care for women with a multidisciplinary approach. The aim of~     this study is to determine whether psychoeducation oriented in problem solving is effective~     in preventing the development of postpartum depression in women with very high risk.~      Methodology: screening of 1000 women in 3rd trimester of pregnancy. We expect that 25% have~     at least one risk factor for postpartum depression (250). Of these women, aproximately a 50%~     will have a very high risk of developing postpartum depressión and will be included in the~     study (n = 125). These women will be randomized to two groups: treatment with psychotherapy~     focused on problem solving (6 sessions: 1 individual session + 5 group sessions) or usual~     care control group (usual postpartum control).~      After treatment, women will be evaluated twice, at the end of therapy and at 6 weeks.~     Survival curves will be used tu assess the time it takes patients to develop major depression~     in the postpartum.~   "
95041|NCT02323139|"~     This study is a phase Ib add-on study of the combination of LDE255 to azacitidine in patients~     without marrow response after at least 6 cycles of azacitidine.~   "
95042|NCT02323126|"~     To determine the efficacy and safety of Nivolumab in combination with EGF816 and of Nivolumab~     in combination with INC280 in previously treated NSCLC patients~   "
95043|NCT02323113|"~     The purpose of the Phase 1b dose finding phase is to determine the safety, tolerability, and~     maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of TAK-659 in participants with~     relapsed or refractory AML. The purpose of the Phase 2 expansion phase is to evaluate~     preliminary efficacy of TAK-659 in relapsed or refractory AML as measured by overall response~     rate (ORR).~   "
95044|NCT02323100|"~     We propose to test the effectiveness of the combination of CF pancreatic enzyme replacement~     therapy (PERT) on absorption of Ravicti® and subsequent restoration of nasal epithelial~     cystic fibrosis transmembrane conductance regulator (CFTR)-mediated chloride transport during~     the nasal potential difference (NPD) test. Funding source FDA Office of Orphan Products~     Development.~   "
95045|NCT02323087|"~     The purpose of this study is to determine whether point-of-care susceptibility testing~     improve correct choice of antibiotics, clinical and microbiological outcome in patients with~     uncomplicated urinary tract infection in general practice compared to point-of-care urine~     culture.~   "
95046|NCT02323074|"~     In this project we will design a control algorithm to identify the focalized motor-related~     clusters for hand function on each stroke patient. A real-time feedback will control the~     robotic hand when motor imagery is successfully identified. Finally, the focalized BCI-robot~     training will be compared in a randomized controlled trial to evaluate the training~     effectiveness and changes in the EEG patterns.~   "
95047|NCT02323061|"~     A BCI system for stroke subjects will be designed in an attempt to train the motor-related~     areas in their brains responsible for hand open/close function. A robot hand will be used and~     controlled by the system in real time based on EEG pattern for identification of motion~     intention for hand movements in the motor cortex. A randomized controlled trial study design~     will be adopted. All subjects will be assessed by clinical assessments including FMA and~     neuroimaging assessments using multimodal MR techniques before and after the training to~     evaluate training effectiveness.~   "
95048|NCT02323048|"~     The aim of the study is to extend our investigations of drug-associated conditioning with~     healthy volunteers. The investigators have recently completed a pilot study demonstrating~     that subjects show an increase in self-reported preference for a visual stimulus paired with~     stimulant drug administration. Furthermore, our pilot data suggest that methamphetamine acts~     synergistically with rewards in the environment, such that this conditioning effect is~     facilitated by experiencing the drug in the presence of rewarding, or positive events, such~     as earning money. The investigators now aim to extend these findings by assessing not only~     self-reported preference, but also attentional and psychophysiological (electromyogram; EMG)~     responses to the drug-associated stimuli.~   "
95049|NCT02323035|"~     This investigation is designed to evaluate the at-home usability, performance, user~     acceptance and reliability of the Headgear with a CPAP Mask for a duration of 2-4 weeks.~   "
95050|NCT02323022|"~     The purpose of this study is to compare the clinical efficacy and safety of IAC regimen and~     IA regimen as induction chemotherapy for initial diagnosed AML patients. 840 cases are~     supposed to recruited in 3 years.~   "
95051|NCT02323009|"~     This is a study to evaluate whether PEEP adjusted by use of an esophageal balloon to overcome~     negative transpulmonary pressure; or adjusted by use of CStat to achieve the best effective~     static compliance will have any effect on outcomes with respect to ventilator weaning in~     tracheotomized morbidly obese patients (BMI >=40) with at least one failed prior weaning~     attempt.~   "
95052|NCT02322996|"~     The goal of the current study is to combine existing and new tools for quantifying patient~     self-report to characterize changes in acute pain. The ability to quantitatively measure~     self-report provides behavioral pain phenotypes that can serve as the basis for clustering~     patients into sub-groups based on their self-report of their symptoms, eliminating observer~     based perceptions of patients' pain.~   "
95053|NCT02322983|"~     Cerebral Palsy induces oral alterations that impact on oral health, requiring dental~     treatment. The objective of this study was to evaluate the use of conscious sedation with~     nitrous oxide (N2O) in the control of stress during dental treatment in individuals with~     Cerebral Palsy.~   "
95054|NCT02322970|"~     Investigators aim to assess sensitivity and specificity of transcranial doppler in ruling out~     intracranial hypertension in all patients admitted to intensive care unit for brain injury~     and needing Intracranial Pressure (ICP) monitoring (according to international guidelines).~     Non invasive ICP measurement through the use of transcranial doppler will be carried out~     before and after standard invasive ICP monitoring placement.~   "
95055|NCT02322957|"~     This study is designed to evaluate the potential for a PK drug-drug interaction between~     FV-100 and ritonavir. The study is a single-center, open-label, randomized, 2-way crossover~     design in healthy volunteers.~   "
95071|NCT02322736|"~     The study will shed additional light on the impact of Vectibix® under the current, standard~     clinical conditions of mCRC treatment in Greece. It will provide data on the duration and the~     outcomes of Vectibix® treatment in real-life setting.~   "
95056|NCT02322944|"~     This study aims to develop quality improvement strategies and relevant tools focusing on~     reperfusion therapy in patients with STEMI, and to evaluate their effectiveness via a~     hospital-level cluster randomized clinical trial, based on the nationally representative~     collaborative network of over 100 hospitals established in China PEACE retrospective study.~     In a baseline survey period, through consecutively recruiting all eligible inpatients and~     collecting relevant medical information, the performance of all participating hospitals~     before the implementation of the intervention will be assessed. During the following~     intervention period, 6-10 hospitals that show the strong willingness and ability to~     collaborate will be selected as process optimization group. Their clinical pathways and~     team building will be re-organized for the purpose of quality improvement, and develop~     individualized treatment strategies and process. Meanwhile, other participating hospitals~     will be divided into intervention and control groups in a 1:1 ratio, in which the~     intervention group will take the treatment improvement strategy into implementation, while~     the control group will maintain the routine practice pattern. All hospitals will~     consecutively recruit qualified patients in the same method adopted in baseline period. Then~     the reperfusion rates and other performance measures will be compared among different groups~     (process optimization, intervention and control).~   "
95057|NCT02322931|"~     The investigators will assess the feasibility of intraoperative use of C-arm cone-beam CT~     imaging for intraoperative dosimetric evaluation in prostate low-dose-rate (LDR)~     brachytherapy. Patients recruited are those who will receive standard LDR brachytherapy for~     prostate cancer treatment. Consenting patients will undergo additional 3D C-arm cone-beam CT~     imaging (3D C-arm) and motorized trans-rectal ultrasound (TRUS). Volumetric and dosimetric~     measures will be compared to those using the standard Day-0 CT images. The investigators hope~     that the intraoperative 3D C-arm provides quality assurance measures sufficient to eliminate~     the need for Day-0 CT LDR brachytherapy and provide the opportunity for intraoperative~     modification of seed delivery plan.~   "
95058|NCT02322918|"~     The purpose of this study is to determine if candidate polymorphisms in brain-derived~     neurotrophic factor (BDNF) and catechol-o-methyl transferase (COMT) are predictive of~     psychosis disorder severity, symptomology, and resolution in patients at BCPP. A secondary~     objective will be to form a biorepository of blood and saliva samples from patients at BCPP~     so that further genetic, proteonomic and pharmacogenomic studies may be done to gain insight~     into the genetic basis of differences in psychosis disorder presentation and manifestation,~     and differences in response to antipsychotic drug treatment.~   "
95059|NCT02322905|"~     Informal caregivers of cancer patients report high levels of psychological distress as~     evidenced in markedly increased levels of anxiety and depression. High levels of~     psychological distress in caregivers have also been found to be associated with poorer health~     and increased levels of pro-inflammatory cytokines that are well-established risk factors for~     physical illness and stress-related mortality. Previous psychological interventions using~     cognitive methods have only produced small effect sizes and more research on how to~     effectively alleviate caregiver burden is needed. The proposed project will investigate the~     effect of Emotion Regulation Therapy (ERT) for caregivers of cancer patients. ERT is a novel~     approach specifically targeting emotion regulation with the aim of improving mental and~     physical health. The effect of ERT will be examined in a randomized controlled trial~     comparing ERT to usual medical care (UMC).~   "
95060|NCT02322892|"~     The main purpose of this pilot study is to test the effects of thiamine (vitamin B1)~     administration before and after major cardiac surgery. Half of patients will receive thiamine~     and the other half will receive placebo.~      The investigators' main hypothesis is that thiamine will improve cellular oxygen consumption~     and lead to decreased levels of post-operative lactate levels and ultimately improved patient~     outcomes.~   "
95061|NCT02322879|"~     A purpose of this protocol is to is to compare the metabolites of the toxic bioactivating~     pathway after acetaminophen alone or acetaminophen followed by Propylene Glycol (PG) and to~     determine if it prevents the formation of the toxic metabolites of acetaminophen.~   "
95062|NCT02322866|"~     To evaluate the efficacy and safety of an approximate 1.5 mg/kg/day dose of oral sarecycline~     compared to placebo in the treatment of moderate to severe facial acne vulgaris~   "
95063|NCT02322853|"~     Metastatic breast cancer (MBC) remains an incurable disease and despite an improvement of the~     effect of systemic treatments. After relapse on first-line non-steroidal aromatase inhibitor,~     current clinical practice and treatment guidelines include tamoxifen, fulvestrant (an ER~     antagonist) and exemestane as available options (NCCN treatment guidelines 2012), but in this~     context of resistance, their efficacy are poor.~      Some results confirm the possibility to improve the efficacy of tamoxifen in metastatic~     setting by a combination with therapy targeting signal transduction pathways. Other~     transduction pathways seem to be involved in endocrine sensitivity/resistance, such as~     RAS/RAF/MEK/MAK pathway.~      LY2228820 inhibits the activity of p38 MAPK (selective inhibitor of the α and β isoforms of~     p38 MAPK in vitro) and reduces phosphorylation of its cellular target, MAPK-activated protein~     kinase 2 (MAPKAP-K2).~   "
95064|NCT02322827|"~     This study is designed to see how HIV infected patients perform when taking a single fixed~     dose HIV medication compared to a regimen with multiple tablets. The study is also going to~     be looking at the differences in complications between the two groups.~   "
95065|NCT02322814|"~     This three-cohort, multi-stage, randomized, Phase II, multicenter trial will evaluate the~     safety and tolerability and estimate the efficacy of cobimetinib plus paclitaxel versus~     placebo plus paclitaxel in Cohort I, of cobimetinib plus atezolizumab plus paclitaxel in~     Cohort II, and of cobimetinib plus atezolizumab plus nab-paclitaxel in Cohort III in~     participants with metastatic or locally advanced, triple-negative adenocarcinoma of the~     breast who have not received prior systemic therapy for metastatic breast cancer (MBC).~     Participants may continue on study treatment until the development of progressive disease~     (PD) or the loss of clinical benefit, unacceptable toxicity, and/or consent withdrawal. The~     Cohort I target sample size is 12 participants for the safety run-in stage and approximately~     90 participants in the expansion stage. Each of Cohorts II and III will consist of a safety~     run-in stage of approximately 15 participants followed by an expansion stage of approximately~     15 participants.~   "
95072|NCT02322723|"~     In Israel, data is lacking regarding the long-term effectiveness of Adalimumab in outpatient~     real life setting. Moreover, the association between long-term effectiveness of Adalimumab~     and patients' functional status as well as cultural aspects of sick leaves and visits to~     physician's clinics has not been demonstrated in this population. This study will collect the~     required data in real life settings.~   "
95073|NCT02322710|"~     Evaluation of non-inferiority on healing rates of two dressings Urgotul and TulleGras MS in~     the treatment of surgical acute wounds.~   "
95074|NCT02322697|"~     Patients on chronic hemodialysis without obstructive coronary artery disease identified by~     coronary angiography were randomly divided into the two groups: carnitine group and control~     group. SPECT using FFA analogue, BMIPP, was performed before and one year after intravenous~     administration of L-carnitine (1000 mg on every dialysis session). Control group received the~     examination of BMIPP SPECT at the same time of the carnitine group. The effects of chronic~     intravenous administration of L-carnitine on myocardial fatty acid metabolism were~     investigated among this population.~   "
95075|NCT02322684|"~     The purpose of this study is to assess the success rate of bougie-guided endotracheal~     intubation compared to blind intubation through the Air-Q intubating laryngeal mask~   "
95076|NCT02322671|"~     This study is designed to estimate the bioavailability of montelukast from the 5 milligrams~     (mg) montelukast sodium (GW483100) test formulations relative to 5 mg montelukast sodium~     reference chewable tablets (innovator product). It is an open-label, randomized, single dose,~     three-way cross over, six sequence study in 18 healthy human subjects. Each subject will~     participate in all three treatment periods. Subjects will be randomized to one of six~     sequences and administered one of the three treatments A, B or C in each treatment period,~     where Treatment A is 5mg chewable tablet of reference 5 mg montelukast sodium reference~     chewable tablets (innovator product), Treatment B is test formulation 1: 5mg montelukast~     sodium (GW483100) chewable tablet and Treatment C is test formulation 2: 5mg montelukast~     sodium (GW483100) chewable tablet. The treatment periods will be separated by a washout~     period of 7 to 14 days. Total duration in the study for each subject will be approximately 8~     weeks from screening to the follow-up visit.~   "
95077|NCT02322658|"~     This is an open-label, randomized, two-period, two-treatment, two-sequence, balanced, single~     dose, crossover, oral bioequivalence study in healthy, adult, human subjects under fed~     conditions.~   "
95078|NCT02322645|"~     This is an open-label, randomized, two-period, two-treatment, two-sequence, balanced, single~     dose, crossover, oral bioequivalence study in healthy, adult, human subjects under fasting~     conditions.~   "
95079|NCT02322632|"~     An open-label, balanced, randomized, two-treatment, two-sequence, two-period, single-dose,~     crossover oral bioequivalence study in healthy subjects under fasting conditions.~   "
95080|NCT02322619|"~     An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose,~     crossover, oral bioequivalence study in human subjects under fasting conditions.~   "
95081|NCT02322606|"~     The purpose of this study is to assess the safety, tolerability and pharmacokinetics of~     TAK-137 in healthy male subjects.~   "
95082|NCT02322593|"~     The purpose of this trial is to evaluate the efficacy of TAS-118 plus Oxaliplatin compared~     with S-1 plus Cisplatin in overall survival in patients with advanced gastric cancer.~   "
95083|NCT02322580|"~     The purpose of this study is to investigate the association between trough serum levels of~     etanercept, antibodies towards etanercept and its effectiveness in psoriasis patients.~   "
95084|NCT02322567|"~     The purpose of this study is to examine the relationship between pre-operative LV diastolic~     function and post-operative complications and kidney function in living-donor kidney~     transplantation patients.~   "
95085|NCT02322554|"~     The goal of the Cellular and Tissue Based Therapy Registry (CTPR) for Wounds is to provide~     real world patient data from electronic health records submitted to meet Stage 2 Meaningful~     Use in order to understand the value of these products among patients with chronic wounds and~     ulcers. Randomized, controlled trials to establish product efficacy routinely exclude~     patients with the co-morbid conditions common to patients seen in usual clinical practice and~     thus the results of these RCTs tend to be non-generalizable. Little is known about the~     effectiveness of CTPs among typical patients.~   "
95086|NCT02322541|"~     The study will consist of a single 5-day dietary treatment period. Subjects will consume an~     Allium-free diet for 3 days. Alliums are vegetables such as garlic, onions, chives, shallots,~     and leeks. On day 4, subjects will consume a breakfast consisting of garlic and will then~     provide blood and urine samples for 10 hours, and on the following morning.~   "
95087|NCT02322528|"~     The purpose of this study is to evaluate the effects of an anti-inflammatory drug (Lotemax®)~     on the surface of the eye and tear film (a film that coats the eye which is made up of oil~     and water).~   "
95088|NCT02322515|"~     The relevance of this study is to determine the effects of a patellar taping on muscle~     activation of the vastus medialis oblique (VMO), vastus lateralis (VL) and gluteus medius~     (GM) during different proprioceptive exercises frequently utilized in rehabilitation program.~   "
95089|NCT02322502|"~     The aim of this study is first to assess if desflurane is superior in order to achieve a~     faster emergence from anesthesia.~   "
95090|NCT02322489|"~     15 participants will be included in the present study. They will attend two groups of three~     sessions (i.e. sessions 1-2-3 and sessions 4-5-6) spaced by 3 months:~        -  session 1 and 4 (performed a few days before the experimental session): session for~          participants to get familiarized with the test battery.~        -  session 2 and 5: experimental session (the test battery followed by the provocative~          task, the test battery, the one-hour treatment and the test battery again).~        -  session 3 and 6 (performed 2 days later): the test battery.~      The test battery included flexibility, functional, pressure pain threshold tests.~      The provocative task was an isokinetic eccentric task for knee flexors and extensors.~      The treatment was either a microcurrent therapy or a placebo microcurrent therapy.~   "
95091|NCT02322476|"~     Welcome or not Herpes Simplex virus (HSV) is an ever present guest in the intensive care unit~     (ICU). Several studies have documented a high frequency of HSV reactivation in critically ill~     patients despite that clinical impact remains unknown.~   "
95092|NCT02322463|"~     Early and appropriate pain management in the emergency department (ED) is an important aspect~     of child care. Studies in the adult population revealed that ethnicity might be associated~     with disparities in analgesia and opioid treatment in ED patients suffering from limb~     fractures. The investigators aim to explore if ethnicity has an influence on analgesic~     practice in the pediatric ED. The objective of this study is to determine whether minority~     population Arab children with orthopedic injuries are less likely than Jewish children to~     receive oxycodone for limb fracture.~   "
95093|NCT02322450|"~     2QG1 is a Phase IIa study aiming to assess the blood pressure lowering effect of 4-week~     administration of QGC001 oral doses in patients with grade I or II essential hypertension~     compared to placebo, to assess the safety and tolerability, to obtain preliminary PK~     information for QGC001 given as multiple oral doses and to determine preliminary PD profile~     of QGC001 multiple oral doses on plasma and urine hormones, which will be compared to that of~     placebo.~   "
95094|NCT02322437|"~     This study aims to evaluate whether psychiatric home treatment is an effective and efficient~     alternative to acute inpatient care in mental hospitals. A one-year prevalence cohort of~     psychiatric patients in need of hospitalization are randomly assigned to either treatment at~     inpatient wards (treatment as usual) or a new care model with the additional option of~     treating patients at their homes by mobile care teams. The primary focus is on checking~     whether optional home treatment leads to a reduction of inpatient days during a two-year~     follow-up period. In addition, the two service models will be compared regarding treatment~     cost and outcomes as well as satisfaction of patients and their relatives with psychiatric~     care.~      Furthermore, a sub-cohort of randomly chosen patients from the prevalence-cohort will be~     examined by a highly trained clinical assessor to test and verify the diagnoses and the~     clinical ratings made by the staff members of the mental hospital under routine everyday~     conditions.~   "
95095|NCT02322424|"~     Pancreatic fistula (PF) grade C, defined by the International Study Group of Pancreatic~     Fistula (ISGPF) is associated with a life-threatening complication after~     pancreaticoduodenectomy(PD). Therefore, The aim of this study is to clarify the risk factors~     for grade C PF by Japan and Taiwan cooperative project.~   "
95096|NCT02322411|"~     The overall goal of this randomized controlled pilot study is to characterize effects of~     SwallowSTRONG® Device-Facilitated Isometric Progressive Resistance Oropharyngeal (DF I-PRO)~     therapy in a dose response framework on swallowing-related outcomes in a group of unilateral~     ischemic stroke patients. These results will be used to determine adequate sample size in~     order to support a larger clinical trial focused on the efficacy of this therapy approach for~     improving swallowing safety. The first aim is to determine differences in swallowing~     physiology and bolus flow measures a) between a group of unilateral ischemic stroke subjects~     undergoing SwallowSTRONG® DF I-PRO therapy and controls and b) between 8 and 12 weeks of~     treatment. The second aim is to examine changes in level of oral intake and swallowing~     quality of life in post-stroke patients undergoing DF I-PRO therapy as compared to a control~     group and as they relate to treatment duration response at 8 weeks and 12 weeks. The third~     aim is to evaluate effects of DF I-PRO therapy on overall health status reflected by the~     number of pneumonia diagnoses and overall hospital readmission rates in post-stroke subjects~     undergoing DF I-PRO therapy compared to controls.~   "
95097|NCT02322398|"~     The purpose of this retrospective study was to assess the outcome of In Vitro Fertilization~     (IVF) according to the type of medication used for controlled ovarian stimulation (COS). The~     study compared the pregnancy rate obtained by 398 patients who had received COS with~     recombinant Follicle Stimulating Hormone (rFSH) plus recombinant Luteinising Hormone (rLH) in~     2:1 ratio vs. the one observed in 450 patients who had been treated with human Menopausal~     Gonadotropin (hMG), stratifying results according to the number of retrieved oocytes.~   "
95098|NCT02322385|"~     Autosomal dominant polycystic kidney disease (ADPKD) is an inherited disease. We plan DNA~     analysis using the next generation sequencer (NGS) and examine the relationship between~     mutational types and clinical phenotypes. The accuracy of DNA analysis with NGS is tested by~     Sanger's method. The kidney and life survival curves will be compared between PKD1, PKD2 and~     non-ADPKD family members.~   "
95099|NCT02322372|"~     The investigators of the current study aimed to evaluate the effect of spinal anesthesia with~     low dose bupivacaine combined with femoral blockade on duration of anesthesia and time of~     first analgesic requirement during postoperative period~   "
95100|NCT02322359|"~     Context: Chest compressions represent an important physical effort leading to fatigue and~     cardiopulmonary resuscitation quality degradation. Despite a known harmful effect of chest~     compressions interruptions, current guidelines still recommend provider switch every 2~     minutes. Feedback impact on chest compressions quality during an extended cardiopulmonary~     resuscitation remains to be assessed.~      Study design: simulated prospective monocentric randomized crossover trial. Participants and~     methods: Sixty professionals rescuers of the pre-hospital care unit of University Hospital of~     Caen (doctors, nurses and ambulance drivers) are enrolled to performed 10 minutes of~     continuous chest compression on manikin (ResusciAnne®, Laerdal), twice, with and without a~     feedback device (CPRmeter®). Correct compression score (the main criterion) is defined by~     reached target of rate, depth and leaning at the same time (recorded continuously).~      Hypothesis: Feedback device delay fatigue effect arises during cardiopulmonary resuscitation.~   "
95101|NCT02322346|"~     The investigators aimed to evaluate the effects of different concentrations of preincisional~     peritonsillar levobupivacaine (0.25% ve 0.5%) on postoperative pain and bleeding~   "
95102|NCT02322333|"~     This is a double-blind, placebo-controlled, randomized, multi-center study. Subjects agreeing~     to participate in the study and meet the entry criteria assessed at the screening visit, will~     begin a 28 day baseline period to confirm their diagnosis, as well as establish baseline~     migraine characteristics. During this baseline period, subjects will continue treating their~     migraines as usual, simply recording the information in a daily headache diary. Subjects who,~     after completing the baseline, continue to meet entrance criteria will be eligible to enter~     into the treatment phase and be randomized according to the Clinvest generated randomization~     schedule. Approximately 142 subjects (71 subjects per arm) will be randomized and enter the~     treatment phase receiving MLD10 or placebo in a 1:1 design at 6 United States sites. Diary~     assessments will collect study medication adherence, pain severity, headache symptoms, acute~     medication usage, and unusual symptoms. Serum samples will be collected and analyzed for~     ionized magnesium, electrolytes, and creatinine.~   "
95103|NCT02322320|"~     This study is designed to compare long-term outcomes among patients randomized on the BMT CTN~     0702 protocol (NCT01109004), A Trial of Single Autologous Transplant with or without~     Consolidation Therapy versus Tandem Autologous Transplant with Lenalidomide Maintenance for~     Patients with Multiple Myeloma. It is hypothesized that use of novel anti-myeloma agents~     will improve long-term progression-free survival (PFS) after high-dose melphalan followed by~     autologous hematopoietic cell transplantation (HCT) as compared to a second autologous~     transplantation.~   "
95104|NCT02322307|"~     HealthPROMISE is a mobile application (app) for patients that allows regular tracking of~     symptoms by patients and communicates them to physicians. The purpose of this randomized~     controlled trial is to determine the impact of the HealthPROMISE application on improving~     patient outcomes. The trial will look at how much patients use the application, whether~     physicians change treatment in response to new information from patients, and how the~     patients quality of life change over the span of the study. The investigators hypothesize~     that HealthPROMISE will enhance physician-patient communication and improve clinical~     outcomes.~   "
95105|NCT02322294|"~     This study is investigating the effects of 8 weeks of supplementation with Glucodia™, on~     glucose parameters, triglycerides and body weight as compared to a placebo. Half of the~     subjects will be administered Glucodia™, while the other half will receive placebo.~   "
95106|NCT02322281|"~     The purpose of this study is to compare the anti-tumor efficacy of oral single-agent~     rociletinib, as measured by investigator assessment of the PFS, with that of single-agent~     cytotoxic chemotherapy in patients with EGFR-mutated, advanced/metastatic NSCLC after failure~     of at least 1 previous EGFR-directed TKI and at least 1 line of platinum-containing doublet~     chemotherapy.~   "
95107|NCT02322268|"~     The purpose of this study is to determine whether Cosmos caudatus is effective as an adjuvant~     therapy for type 2 Diabetes Mellitus.~   "
95108|NCT02322255|"~     Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease~     characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) that result~     in abnormal bone formation in muscles, tendons, and ligaments. Flare-ups begin early in life~     and may occur spontaneously or after soft tissue trauma, vaccinations, or influenza~     infections. Recurrent flare-ups progressively restrict movement by locking joints leading to~     cumulative loss of function and disability. This 3-year, non-interventional, two-part,~     natural history study is designed to gain insight into total body HO, FOP disease~     progression, the impact of FOP on subjects' physical functioning, and clinical features and~     biomarkers that may be useful in the diagnosis and monitoring of disease progression. This~     natural history study will also provide important information to inform the design of~     subsequent interventional trials.~   "
95109|NCT02322242|"~     A standard interscalene nerve block is performed with long acting local anesthetic~     (bupivacaine or ropivacaine in concentrations varying from 0.25% to 0.75%). The purpose of~     this study is to investigate the effect of the addition of perineural dexamethasone (4mg) to~     a standard ropivacaine solution (0.5%) on analgesic duration of low dose interscalene block~     compared to ropivacaine alone for interscalene block with systemic dexamethasone.~      Ropivacaine is not an intervention as a local anesthetic is pre-requisite to performing a~     nerve block.~   "
95110|NCT02322229|"~     The purpose of this study is to observe the anatomical and functional outcomes of ocriplasmin~     (JETREA®) over a 6-month follow-up period.~   "
95111|NCT02322216|"~     The purpose of this study is to evaluate olopatadine 0.2% QD (once per day) compared to~     olopatadine 0.1% BID (twice per day) in the treatment of ocular itching associated with~     allergic conjunctivitis.~   "
95112|NCT02322203|"~     Background:~      - Niacin is a vitamin in many foods, including meats, fish, fruits, and vegetables. It is~     often used as a dietary supplement that causes many improvements in the body. Researchers~     think it can affect heart health.~      Objective:~      - To better understand the good effects of niacin supplementation on cholesterol, fat~     metabolism, and vascular health.~      Eligibility:~      - Adults 18 years of age and older with fasting good cholesterol (HDL-C) below 60 mg/dL.~      Design:~        -  Participants will come to the clinic 4 times during the study.~        -  They will complete a 7-day food journal before visits 1 and 3.~        -  At visit 1, participants will be screened with questions about their diet and exercise,~          medical history, and any drugs and vitamins they take. Vital signs and body mass index~          will be measured.~        -  They will have a Cardio-Ankle Vascular Index (CAVI) test of the arteries. Blood pressure~          will be taken in the arms and legs and the heart will be monitored.~        -  Blood will be drawn. Participants will fast for 8 12 hours before this.~        -  Women will have a pregnancy test.~        -  Eligible participants will get a 2-week supply of niacin. They will take 2 tablets daily~          for one week, then 4 daily.~        -  Visit 2 will be 2 weeks after visit 1 and the niacin dose will be increased. Visit 3~          will be 16 weeks after visit 1, and participants will stop taking niacin. Visit 4 will~          be 4 6 weeks after stopping niacin.~        -  During study visits, participants will repeat visit 1 tests.~   "
95113|NCT02322190|"~     Background:~      - Some allogeneic stem cell transplant recipients get acute graft-versus-host disease (GVHD).~     They always get steroids as the first treatment, but this may not work. Those people where~     steroids are not enough may benefit from a treatment called extracorporeal photopheresis~     (ECP). ECP exposes white blood cells to ultraviolet light outside the body. Researchers want~     to study how certain markers in the blood predict the severity and outcome of acute GVHD and~     how ECP treatments work for people with acute GVHD. They will also study how these markers in~     the blood may help predict who should get ECP and its effects on the immune system.~      <TAB>~      Objectives:~      - To learn more about treatments for acute GVHD after allogeneic stem cell transplantation.~      Eligibility:~      - Adults with acute GVHD enrolled in an NCI allogeneic transplantation protocol.~      Design:~        -  Transplant physicians will confirm participant eligibility.~        -  Participants will receive treatment with steroids for their acute GVHD as prescribed by~          their transplant physician. This will continue while they are enrolled on this study.~        -  If steroids work in treating their acute GVHD, then every 28 days for 6 months,~          participants will have:~        -  a physical exam.~        -  blood tests.~        -  If steroids do not work, participants will get additional treatments as prescribed by~          their transplant physician who may choose to use ECP as a part of this additional~          treatment.. For ECP, blood is removed through an intravenous (IV) catheter. A machine~          separates the white blood cells from the other blood parts. Those cells are treated with~          methoxsalen and exposed to ultraviolet light. Then they are returned to the participant~          through their IV.~        -  Participants who get ECP will over at least 6 months have:~        -  veins researched. They may have a catheter placed in a larger vein in the chest or~          groin.~        -  multiple blood tests.~        -  multiple pregnancy tests (if needed).~        -  multiple ECP procedures.~        -  At the end of ECP treatment and 6 months after ECP, participants will have additional~          physical exams and blood tests.~   "
95451|NCT02317757|"~     These days, there is higher proportion of elderly cancer patients. Most of them have~     comorbidities, borderline performance status and nutritional status. The discontinuation of~     chemotherapy due to unbearable toxicities was not uncommon. Comprehensive geriatric~     assessment might be beneficial in selection of suitable elderly patients for chemotherapy~     administration.~   "
95114|NCT02322177|"~     Background:~      - People with inborn errors of metabolism can t turn food into energy the right way. This can~     affect a person s growth and health. Researchers want to know how this condition affects a~     pregnant woman and her baby.~      Objectives:~      - To collect data from the medical records of women with an inborn error of metabolism. Also,~     to create a pregnancy registry of inborn errors of metabolism.~      Eligibility:~        -  Women with an inborn error of metabolism who either:~        -  have been pregnant in the past,~        -  are currently pregnant, or~        -  have recently talked with their doctor about becoming pregnant.~      Design:~        -  This study will collect data only. No extra tests will be done.~        -  Participants will be in the study for the length of their pregnancy and for 1 year after~          delivery.~        -  Participants will answer questions about their family s health.~        -  The participant s doctor will send their medical records to researchers. These may~          include data about:~        -  Last health care visit before pregnancy~        -  Blood, urine, ultrasound, or lab results during pregnancy~        -  Delivery and recovery after delivery~        -  Researchers will ask for the test(s) used to confirm pregnancy.~        -  After the participant has her baby, researchers will ask for data about how the baby is~          doing. This may include when the baby is sitting, walking, talking, etc.~        -  The data will be placed into a database. The database will not include the participant s~          name or identifying data.~   "
95115|NCT02322164|"~     Background:~      - Researchers are studying a topical (skin) cream that reduces pain. This is called an~     analgesic cream. They want to try a new test to better measure how well it works. Heat will~     be applied to the participants arms and they will judge the intensity of the temperatures.~     Researchers will compare the pain reduction from this cream to other pain relief treatments.~      Objective:~      - To better measure the effects of a pain-relieving (analgesic) cream.~      Eligibility:~      - Healthy volunteers ages 18 50.~      Design:~        -  There will be 2 study sessions.~        -  Session 1 will be about 1.5 hours.~             -  Participants will be screened with physical exam and urine drug test. They will~               answer medical and psychological questions.~             -  Participants will have sensory testing.~        -  A moisturizer will be put on their arms. A heating device will be placed on their arms.~          It gives heat pulses of about 2 seconds each. Some are warm and some are very hot.~          Participants will say how strong each pulse is. They can move away if it gets painful.~        -  Then the pain-relieving cream will be put on one arm. The moisturizer will be put on the~          other. Participants will get more pulses and rate them. They will also get pairs of~          pulses and compare them.~        -  Some participants will return for session 2 for 1 hour. They will receive similar~          sensory testing as in session 1.~   "
95116|NCT02322151|"~     Background:~      - The drug filgrastim (rGCSF) increases the number of blood-forming cells in the bloodstream.~     These cells can be collected from donors bloodstreams and used for transplant. Studies have~     shown that rGCSF is present in the breast milk of nursing mothers who are taking it. Based on~     these studies, it is now recommended that a nursing mother should not breastfeed from the~     time she receives the first dose of the drug until 2 days after the final dose. Researchers~     want to study the amount of the drug and its effect on the cells present in donor blood and~     breast milk. They hope to better understand the effects of this drug on breast milk.~      Objectives:~      - To understand the effects of filgrastim on breast milk.~      Eligibility:~      - Women enrolled in NIH protocol 00-CC-0165 and currently breastfeeding.~      Design:~        -  Participants will receive rGCSF daily for 5 days. They will have blood taken daily.~        -  Participants will get a freezer bag containing 10 sterile, labeled containers for breast~          milk collection.~        -  Participants will transfer some of the breast milk they pump into one of the containers.~          They will write the date and time the milk was collected on the container. They will~          freeze the samples. Any remaining milk should be disposed of.~        -  Participants will bring the samples to NIH on the day of their stem cell collection~          procedure.~        -  For days 1 and 2 after stem cell collection, participants will continue to collect and~          freeze breast milk samples and dispose of any remaining milk.~        -  For days 3 5 after stem cell collection, participants will collect and freeze samples.~          They can also resume normal breastfeeding.~        -  A research nurse will arrange to collect the samples.~   "
95117|NCT02322138|"~     The study objective is to evaluate the gastrointestinal tolerance of infant formula~     supplemented with prebiotics.~   "
95118|NCT02322125|"~     Powered exoskeletons have emerged recently, promising to offer walking to individuals with~     severe spinal cord injury who are unable to walk. We will use the ReWalk exoskeleton to train~     walking in individuals with chronic, severe spinal cord injury. We will determine the~     characteristics of individuals who most benefit from such training, and identify the~     neuroplasticity induced by the training. We will further determine the feasibility of the~     ReWalk for home and community ambulation.~   "
95119|NCT02322112|"~     Too much body-fat has been linked to a low-grade inflammation throughout the body. This~     inflammation is thought to then cause different diseases, like heart disease and diabetes. A~     lower amount of inflammation is usually seen in people that follow a high fiber diet. A~     reason for this is the microbes that live in our gut. Fiber is a main food source for these~     microbes. This allows fiber to actually change the type of microbes that live in our gut.~     Also, when fiber gets fermented by these microbes, health-promoting waste products get~     released. We aim to determine how exactly our gut microbes contribute to the health~     properties of fiber.~      We hypothesize that fiber's health properties depend on how the gut microbes respond to the~     fiber. To test this, we plan to add three different fibers to the diets of healthy overweight~     and obese individuals for six weeks. We then will determine how the different fibers affect~     an individuals' health by looking at how established markers of health change from adding the~     fiber. Following this, we will see how an individual's gut microbes respond to the added~     fiber. The response will be decided by looking at changes to the microbe community, as well~     as their ability to ferment the fibers. By connecting health outcomes to the gut microbes'~     response, we can test if the gut microbes' response to the fiber determines the fiber's~     ability to effect health. If we can understand how our gut microbes respond to different~     fibers and the importance of that response. Then we could personalize diets to have a greater~     impact on improving health.~   "
95452|NCT02317744|"~     This study will test the effectiveness of the combination of Naltrexone and Bupropion~     relative to placebo for reducing binge eating in persons with obesity and binge eating~     disorder.~   "
95120|NCT02322099|"~     Antiretroviral therapy (ART) initiation is associated with a significant loss of bone mineral~     density (BMD), characterised by increases in bone turnover, which is largely limited to the~     first 48 weeks of therapy. Bisphosphonates, such as alendronate, decrease bone turnover and~     can limit loss of bone mineral density.~      This study aims to determine if a short course of treatment with the oral bisphosphonate~     alendronate can limit loss of bone mineral density associated with initiation of ART in HIV-1~     infected, antiretroviral naive, adult subjects.~   "
95121|NCT02322086|"~     This is a multicenter study of subjects with mild to moderate psoriasis. Subjects will apply~     PH-10 vehicle daily for 28 consecutive days followed by active PH-10 daily for 28 consecutive~     days to their plaque psoriasis areas on the trunk or extremities (excluding palms, soles,~     scalp, facial and intertriginous sites). Biopsies of one target plaque will be collected at~     baseline (at least 7 days prior to first study treatment on Day 1) and at Days 29 and 64,~     with a 7-day interval between biopsy at Day 29 and commencement of application of application~     of active PH-10 on Day 36. Study data from each subject will serve as an internal control~     (i.e., assessment at baseline and at the end of application of PH-10 vehicle) for assessment~     of clinical and cellular response to active investigational agent.~   "
95122|NCT02322073|"~     Visceral obesity and adipose inflammation is considered a driving force of obesity-related~     systemic disease, e.g. liver cirrhosis and chronic kidney disease (CKD). Inflammatory~     resolution is actively regulated by specialized pro-resolving mediators (SPMs), including the~     endogenous eicosanoid LXA4. Impairment of SPMs may underlie development of obesity-related~     pathology.We hypothesize that obese patients who develop obesity-related liver and kidney~     disease do so because they suffer from impaired endogenous production of pro-resolving~     lipids. This will result in aggravated adipose inflammation, which causes systemic~     pathologies such as kidney disease. We thus wish to investigate adipose inflammation and the~     pro-resolving lipid profile of obese subjects with and without CKD and liver disease. We also~     aim to investigate whether LXA4, LXB4 and other anti-inflammatory agents (such as AICAR) can~     alter the phenotype of human adipose macrophages in ex vivo tissue culture.~   "
95123|NCT02322060|"~     In this study, the investigators used the newly developed technique i.e. in vitro activation~     of dormant follicles (IVA) to promote ovarian follicle growth much more efficiently than~     natural, in vivo process for women with Primary Ovarian Insufficiency (POI).Firstly, the~     investigators remove one ovary under laparoscopic surgery. Then, we dissect ovarian cortex~     from the ovarian medulla. The ovarian cortex is cut into small cubes and cultured with medium~     containing drugs to activate dormant follicles. After 2 days of culture, the ovarian cubes~     are transplanted mainly beneath the membrane of Fallopian tubes under laparoscopic surgery.~     The ovarian cortex could be cryopreserve for future re-transplantation and in some cases, for~     convenience to arrange second surgery. Once frozen, the ovary can be preserved~     semipermanently. After transplantation, patients receive ultrasound monitoring together with~     measurement of serum hormone levels for 10-12 months. If growing follicles are detected,~     follicle growth is stimulated by injection of hormones (gonadotropins). Using the same ovum~     pick up approach used in IVF (in vitro fertilization), we pick up oocytes from the follicles~     and fertilize them. Fertilized eggs are cultured and then cryopreserved for future embryo~     transfer.~   "
95124|NCT02322047|"~     The purpose of this study is to see whether the drugs prazosin and naltrexone will decrease~     alcohol cravings and drinking in individuals who have problems with alcohol and have used~     alcohol at risky levels in the past 90 days.~      Prazosin is a medication that is FDA approved for treating people with high blood pressure.~     Some studies have shown that prazosin may also decrease nightmares and improve sleep in~     Veterans suffering from Posttraumatic Stress Disorder (PTSD). The use of prazosin for PTSD~     nightmares is an off-label use. That means that the FDA has not approved prazosin for PTSD~     nightmares. The current study is evaluating an off-label use of prazosin to determine~     whether it is helpful in decreasing alcohol cravings and consumption among people with~     alcohol problems.~      Naltrexone is a medication that is FDA approved for treating alcohol problems.~      This study is sponsored by the Department of Defense and the Congressionally Directed Medical~     Research Program (DoD/CDMRP). We expect approximately 240 participants in this study, which~     will run over approximately 4 years. Study participants will be involved in the study for 7~     weeks, or until they complete the Final Assessment.~   "
95125|NCT02322034|"~     The investigators aim at investigating whether 24-week high intensity interval training might~     exert beneficial effects by modulating neurohormonal axis in patients with chronic heart~     failure (CHF). Furthermore, the effect of detraining on neurohormonal axis in CHF patients~     will be evaluated.~   "
95126|NCT02322021|"~     This is a Phase 2 study to evaluate safety and tolerability of daily dosing with elenbecestat~     (proposed international proprietary name [pINN]) (E2609) in Mild Cognitive Impairment~     (MCI)/Prodromal participants and in participants with Mild to Moderate Dementia due to~     Alzheimer's Disease (referred to as mild to moderate AD).~   "
95127|NCT02322008|"~     Can genetic markers be used to predict anti-TNF response? A cohort was established to~     identify SNPs associated with anti-TNF therapy in patients with inflammatory bowel disease.~   "
95128|NCT02321995|"~     This study aims to evaluate the Zenalux IM1, an optical spectroscopy device with a pressure~     sensor. The pressure sensor is intended to overcome the inconsistencies attributable to~     variations in use of the device. This study will involve using the device on healthy~     volunteers. Three tissue parameters will be used to analyze the pressure effects in two ways:~     within- and across-subject variability. Measurements will be taken under the tongue and on~     the inside of the cheek. The device is noninvasive and is approved for preclinical use.~   "
95146|NCT02321761|"~     Amantadine hydrochloride is one of the drugs given at rehabilitation programs to people who~     suffered Acquired Brain Injury in order to expedite recovery and improve functioning.~      A previous study examined the spatially asymmetric allocation of attention in patients with~     traumatic brain injury (TBI). Patients demonstrated significantly worse performance with~     leftward than with rightward cross-hemi field shifts of attention. This is reminiscence of~     neglect patients. This difference was significantly reduced during and following treatment.~     Our objective is to investigate whether Amantadine Hydrochloride is effective in improving~     allocation of spatial attention and improving function in people with Traumatic Brain Injury.~   "
95129|NCT02321982|"~     The purpose of this study is to determine whether separate- versus same-day preoperative~     consultation affects time to treatment (start to finish), utilization rate of Mohs, rate of~     case cancellations, cost, and patient satisfaction. The investigators hypothesize that~     patients with same-day preoperative consultation will have a shorter time between cancer~     diagnosis and removal but, only when coordination of care is needed, longer time between~     removal and consultation with other specialists, as compared to patients with separate-day~     consultation. The investigators anticipate that patients with same-day preoperative~     consultation will have a decrease in travel cost as compared to patients with separate-day~     consultation. The investigators expect that there will be no difference in various~     satisfaction matters between groups, with the exception of potentially greater convenience~     reported by patients in the same-day preoperative consultation group. Finally, the~     investigators hypothesize that there will be no difference between groups in regards to rates~     of surgery cancellation.~   "
95130|NCT02321969|"~     Experimental studies have shown the chemopreventive properties of green tea extract (GTE) on~     colorectal cancer. And colorectal adenomas are precursors to colorectal cancers. The aim of~     this study is to determine the preventive effect of GTE supplements on metachronous~     colorectal adenomas by giving GTE tablets of which are equivalent of 9 cup-of-green tea per~     day (0.9 g/day GTE, 0.6 g/day Epigallocatechin gallate (EGCG).~   "
95131|NCT02321956|"~     The purpose of this study is to determine whether ultrasound study of the airway to predict~     endotracheal tube size in anesthetized pediatric patients better than the tube size formula~   "
95132|NCT02321943|"~     The objective of this study is to explore the longitudinal course of self-disturbances (SD)~     in schizophrenia. The main aim of the study is to investigate, in a 6-7-year follow-up of a~     representative sample of patients with first-episode schizophrenia, bipolar disorder and~     other psychoses. The overall aim is to expand our knowledge about the role of SDs in~     psychotic disorders. Increased knowledge here will aid diagnosis and treatment. The current~     study is a seven year follow-up of this representative cohort, with baseline measures of SDs~     and a comprehensive clinical and neurocognitive assessment battery.~   "
95133|NCT02321930|"~     This proposal will evaluate if musculoskeletal ultrasound (MSUS) measures or multi-biomarker~     disease activity (MBDA) improve in patients treated with tofacitinib over 3 months, and~     whether early MSUS measures/MBDA can predict response to therapy.~   "
95134|NCT02321917|"~     In this study, the investigators would like to compare a heparin-coated tubing system for~     minimized extracorporeal circulation (MECC) with the conventional tubing system for MECC,~     which does not contain heparin coating. The MECC system has been used since 14 years in the~     investigators' hospital as an extracorporeal system to support circulation and provide oxygen~     to the tissues during coronary artery bypass grafting. Until today, the investigators~     performed more than 5000 MECC procedures in their department.~   "
95135|NCT02321904|"~     The overall aim of this study is to confirm the utility of corneal confocal microscopy (CCM)~     as a new technique to rapidly and non-invasively assess diabetic neuropathy (DN) in children.~     This study will be divided into two phases: Phase 1 will be a cross-sectional study of~     children with type 1 diabetes and normal controls, while phase 2 will be a longitudinal~     assessment of a subgroup of children with type 1 diabetes recruited during Phase 1.~   "
95136|NCT02321891|"~     The investigators examine the efficacy of two different transcranial direct current~     stimulation (tDCS) stimulation protocols in the treatment of anxiety in an open-label pilot~     study.~   "
95137|NCT02321878|"~     This trial is conducted in Asia. The aim of this trial is to evaluate safety and~     effectiveness of Victoza® in patients with type 2 diabetes mellitus (T2DM) in combination~     with antidiabetes agents other than sulfonylurea under post-marketing normal clinical~     practice conditions.~   "
95138|NCT02321865|"~     The objective of this study is to check the dose control method of NPC-02 and the holding~     effect for the target serum zinc concentration in patients with zinc deficiency.~   "
95139|NCT02321852|"~     The purpose of this study is to investigate the effects of the eNOS activating agent~     triflusal on episodic memory and cognitive functions in healthy participants.~   "
95140|NCT02321839|"~     To evaluate the visual outcome, number of injections and visits, and the effect of mental~     status of a treat and extend regimen in managing neovascular age-related macular degeneration~     with intravitreal ranibizumab.~   "
95141|NCT02321826|"~     The aim of this study is to determine the effect of listening to music on sleep quality~     (subjective and objective), daytime dysfunction and neurophysiological arousal in patients~     with insomnia.~   "
95142|NCT02321813|"~     The purpose of the study is to determine whether a quality of life pathway with defined~     diagnostic and therapeutic options improves quality of life in colorectal cancer patients~     during follow-up.~   "
95143|NCT02321800|"~     To determine the efficacy and safety of intravenous S-649266 in hospitalized adults with~     complicated urinary tract infections caused by Gram-negative pathogens.~   "
95144|NCT02321787|"~     The purpose of our study is to evaluate whether utilizing ultrasound assessment during caudal~     epidural injection can reliably identify unrecognized and unsuccessful nerve blocks during~     the procedure, guide proper technique, and alter pain management outcome measurements for~     patients.~      Patients will be randomized to a group either undergoing caudal injection by a trainee using~     typical techniques or by using typical techniques in addition to ultrasound for confirmation~     of successful injection. The patients enrolled in this study will have the same~     intraoperative care, in line with the standard of care. Data will be collected~     intraoperatively and postoperatively on pain scores, time for performance of caudal block,~     and perceived success of the block. There will be no direct benefit to the patients enrolled~     in this study, but future patients may benefit from the use of ultrasound for the~     confirmation of a successful block.~   "
95145|NCT02321774|"~     Monitor stress response in a virtual reality environment using a wearable sensor to analyze~     and track heart rate variability (HRV).~   "
95147|NCT02321748|"~     CYP2C8 is involved in the metabolism of many drugs. So, it is important to assess in vivo the~     inhibitory effect of ASP2151 on that enzyme to determine any possible drug interactions. The~     aim of this trial is to investigate the potential for interaction of ASP2151 with the CYP2C8~     probe substrate montelukast.~   "
95148|NCT02321735|"~     : Stages III and IV serum ovarian cancer are the most lethal of all gynecologic cancers;~     however, some advanced-stage ovarian cancer patients are long-term survivors. These patients~     may provide the key to long-term survival and bring hope to all women with Stages III and IV~     ovarian cancer. There is no meaningful explanation of why some patients with ovarian cancer~     become long-term survivors and what their quality of life is long after their initial~     diagnosis. This research project will specifically determine molecular features within tumors~     along with genetic, quality of life, and lifestyle features that predict for long-term~     survival for patients with Stages III and IV ovarian cancer. It will bring together~     sophisticated molecular techniques, researchers with longstanding interest, a wide spectrum~     of consumer advocates (a number being long-term survivors), and quality of life experts to~     analyze the most carefully maintained patient database in the world—the Gynecologic Oncology~     Group database. We anticipate the results from this project will identify specific~     biochemical pathways and genetic features associated with long-term survival that can be used~     to improve the treatment, survival, and survivorship of patients with this disease. There is~     clearly something unique among patients who survive Stage III or IV ovarian cancer long term,~     and we believe that when we understand what this is, we can increase the number of long- and~     longer-term survivors.~   "
95149|NCT02321722|"~     Glaucoma is an eye disease that damages the optic nerve, it cause blindness if not diagnosed~     and treated properly. The major risk factor for the development and progression of glaucoma~     is increased intraocular pressure. Colonoscopy is one of the most preformed world wide~     screening exam. It is used to detect colon cancer at its early stages. As part of this~     examination, the examiner inflates the inspected colon with air in order to increase the~     colon lumen for better visualization of the colon. As a consequence of the insufflation the~     intrabdominal pressure increases as well. the increase in intrabdominal pressure could~     increase intraocular pressure. The aim of this study is to evaluate the intraocular pressure~     increase while preforming colonoscopy.~   "
95150|NCT02321709|"~     Primary Objective:~      To assess the tolerability and safety of SAR113244 in male and female lupus patients after~     every 4 (Q4) weeks repeated ascending subcutaneous doses of SAR113244.~      Secondary Objectives:~      To assess in male and female lupus patients:~        -  The pharmacokinetics of SAR113244.~        -  The pharmacodynamics of SAR113244 for the following disease-related parameters:~             -  Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus~               Erythematosus Disease Activity Index (SELENA-SLEDAI) score, British Isles Lupus~               Assessment Group (BILAG) score (if applicable), BILAG-Based Composite Lupus~               Assessment (BICLA) (if applicable), systemic lupus erythematosus responder index~               (SRI) (if applicable), Lupus-quality of life (QoL) and Functional Assessment of~               Chronic Illness Therapy (FACIT)-Fatigue, anti-double stranded deoxyribonucleic acid~               antibody (anti-dsDNA Ab) and anti-nuclear antibody levels (ANA) and plasma~               complement levels (C3, C4), erythrocyte sedimentation (SED) rate and C-reactive~               protein.~             -  Peripheral blood B and T cells subsets.~   "
95151|NCT02321696|"~     Work-related upper extremity disorders are common problems in working populations in western~     countries. Lateral epicondylitis (LE) or tennis elbow is the most frequent type of soft~     tissue syndrome of the elbow, with an annual incidence of four to seven cases per 1000~     patients in general practice, and as high as 15 % of workers in highly repetitive hand task~     industries.~      LE is a painful condition, leading to loss of function of the affected limb. Therefore it can~     have a major impact on the patient's work and personal life. If untreated, it persists for an~     average of six to 24 months and associated with significant sickness absence in 5 % of~     affected working-aged adults. The cost is therefore high, both in terms of loss of~     productivity and health care utilization.~      Many treatments have been advocated in the management of LE, possibly implying that much is~     unknown about its etiology and how it best should be treated. Systematic reviews have failed~     to draw any firm conclusions as to what treatment is most effective in managing this~     condition.~      Over the past 10 years acupuncture has gained wider acceptance for treating pain, by both~     clinicians and consumers of health, and there is some evidence suggesting that acupuncture~     treatment is effective in of acute symptoms in LE. A recent study supports that also elbow~     manipulation have a short-term relief of acute symptoms in LE, especially when combined with~     eccentric exercise. Our study will therefore explore the clinical effectiveness of~     physiotherapy versus acupuncture treatment of LE, compared with watchful waiting.~   "
95152|NCT02321683|"~     The purpose of this trial is to evaluate a new method of applying hydroxyapatite coatings on~     cement-less femoral stems.~   "
95153|NCT02321670|"~     A multicentre, prospective, randomized study comparing bulbar urethroplasty with excision and~     primary anastomosis or with an onlay grafting procedure using buccal mucosa.~   "
95154|NCT02321657|"~     RELAX Anaesthetics is a randomised clinical trial assessing the effectiveness of using an~     iPad app with art, music and games to relax and distract children, reduce anaesthetic~     induction time and make drug cost savings prior to surgery.~   "
95155|NCT02321644|"~     This is a two-part, phase 1 study to evaluate the pharmacokinetics and pharmacodynamics of~     multiple doses of CC-90001 and the effects of food and formulation on the pharmacokinetics of~     single dose CC-90001 in healthy subjects. Part 1 involves the exposure of subjects to the~     minimum amount of UV-B light that causes minimally perceptible skin reddening. This will take~     place before dosing (baseline) and 3 times more while on increasing doses of CC-90001. Punch~     biopsies of the exposed areas will be taken and assessed for c-Jun terminal kinase activity.~     Part 2 involves evaluation of changes in pharmacokinetics of 2 formulations of CC-90001 when~     administered in the fasted state and after a high-fat meal.~   "
95156|NCT02321631|"~     The purpose of this study is to study the effects of EPA-enriched supplement compared with~     conventional supplement in malnourished head and neck cancer patients undergone surgery.~     Primary outcome is perioperative weight changing.~   "
95193|NCT02321137|"~     The primary purpose of the LAA-CLOSURE trial is to assess the efficacy and safety of surgical~     closure of LAA in patients undergoing aortic valve replacement. This randomized, prospective,~     open-label international multicenter trial will enroll 1040 patients undergoing aortic valve~     replacement with CHA2DS2-VASC score ≥2 but without an indication for anticoagulation at the~     time of enrollment. Patients will be randomized in 1:1 fashion to standard therapy + surgical~     closure of LAA vs. standard therapy alone. The duration of the study is five years (plus~     additional 10 years).~   "
95157|NCT02321618|"~     African-American men suffer more than most other groups from hypertension (HTN) but often~     have less access and less contact with doctors. Previous work by the study's Principal~     Investigator in Dallas, Texas, and Altadena, California, showed that barbershops are an~     excellent place to identify black men with high blood pressure and to enlist the aid of their~     barbers as healthcare extenders.~      The purpose of this study in Metro Los Angeles (LA) is to compare two types of barber-based~     patient-centered blood pressure programs to see which type is more effective in improving the~     customers' high blood pressure. One type emphasizes blood pressure medication and the other~     type emphasizes lifestyle modification for high blood pressure.~   "
95158|NCT02321605|"~     This study is aimed to test the efficacy of a Positive Psychology Intervention (Best Possible~     Self) over optimism, future expectancies and positive affect at mid-term, in comparison to a~     control group. The principal hypothesis is that Best Possible Self intervention will enhance~     significantly the levels of optimism and positive affect in comparison to the control group~     at short and mid-term.~   "
95159|NCT02321592|"~     The study is designed~        -  to demonstrate efficacy of AFM13 with an optimized treatment schedule~        -  to decide whether AFM13 warrants further investigation in a phase III clinical trial~   "
95160|NCT02321579|"~     This study is designed as a hospital-based cross-sectional and randomized placebo-controlled~     intervention trial. One hundred and fifty patients with either cirrhosis or cirrhosis~     combined with hepatocellular carcinoma (HCC) who meet the inclusion criteria will be~     recruited from Taichung General Veterans Hospital. One hundred patients will be randomly~     assigned to either the 1) placebo group (n = 25); 2) vitamin B-6 group; (50 mg/d, n = 25); 3)~     glutathione (GSH) group (500 mg/d, n = 25); or 4) vitamin B-6 (50 mg/d) plus GSH (500 mg/d)~     group (n = 25) for 3 mo. Data on demography, anthropometry and medical history will be~     collected. Patients with cirrhosis or cirrhosis combined with HCC will have fasting blood~     drawn in the clinics. Additionally, patients who participated in the intervention study will~     have blood drawn at month 0, 1, 2 and 3 during intervention period. Hematological~     measurements, plasma vitamin B-6 status, GSH, inflammatory markers, homocysteine, cysteine,~     SAM, SAH, oxidative stress indicator, oxidized GSH and GSH related antioxidant enzyme~     activities will be analyzed.~   "
95161|NCT02321566|"~     This study is an open-label study to determine the feasibility of Motor Cortex Stimulation~     (MCS) in the treatment of patients with chronic pain of the face or upper extremity. MCS will~     be delivered by use of an electrode and pulse generator, which are FDA approved for spinal~     cord stimulation but are not approved for MCS. The study has as a single-arm design with the~     subject at baseline serving as a control for the response to MCS.~   "
95162|NCT02321553|"~     The purpose of the study is to determine the effect of consumption of brown rice on the risk~     factors of metabolic syndrome (MetS) as compared to consumption of white rice. Brown and~     white rice will be provided in the form of rice cakes and 100g will be consumed per day for 5~     weeks each. The investigators hypothesize that brown rice will have beneficial effects as it~     is rich in fiber and also phytochemicals.~   "
95163|NCT02321540|"~     The goal of Part 1 of this clinical research study is to find the highest dose of (Imbruvica)~     ibrutinib that can be given to patients with non-small cell lung cancer (NSCLC). The goal of~     Part 2 of this clinical research study is to learn if the dose of ibrutinib found in Part 1~     can help to control the disease.~      The safety of this drug will also be studied in both parts of the study.~   "
95164|NCT02321527|"~     The goal of this clinical research is to learn if an ultrasound contrast agent called OPTISON~     (perflutren protein type A) is effective in finding sentinel lymph nodes before surgery.~     Contrast agents can help make ultrasound images more accurate. The sentinel lymph node is the~     first node that may be the target of cancer cells that spread from the tumor.~   "
95165|NCT02321514|"~     The purpose of this study is to generate initial insights into the safety and performance of~     the Tendyne Mitral Valve System. The study includes adult patients with symptomatic mitral~     regurgitation who are not suitable candidates for conventional mitral valve repair or~     replacement. The study will include up to 350 subjects at up to 40 centers. Follow-up~     evaluations will be conducted through 5 years post implantation.~   "
95166|NCT02321501|"~     The goal of this clinical research study is to find the highest tolerable dose of ceritinib~     (LDK378) and everolimus that can be given to patients with NSCLC or head and neck cancer. The~     safety of the drug combination will also be tested.~   "
95167|NCT02321475|"~     The purpose of this study is to determine the effectiveness of EGb 761® (Tanakan®) in Russian~     patients of middle age and younger, suffering from psycho-emotional symptoms added to~     cognitive disorders based on the improvement of FAM test (feeling-healthy, activity, mood~     test) score.~   "
95168|NCT02321462|"~     The purpose of this study is to demonstrate that Eziclen is non-inferior to Fortrans® (the~     reference colonic lavage in Russia) administered in adult subjects scheduled to undergo~     colonoscopy for a routinely accepted diagnostic indication.~   "
95169|NCT02321449|"~     To evaluate the effectiveness of treatment with Circadin based on sleep improvement as~     assessed by the modified Questionnaire Scoring Subjective Characteristics of Sleep before and~     after the treatment~   "
95170|NCT02321436|"~     The purpose of this study is to investigate if early administration (i.e. within 12 weeks~     after stroke) of Dysport® 500 U injections may delay the appearance or the progression of~     upper limb symptomatic spasticity.~   "
95171|NCT02321423|"~     International Pachyonychia Congenita Research Registry (IPCRR) is a patient registry for~     those suffering from Pachyonychia Congenita (PC). PC is an ultra-rare extremely painful skin~     disorder that causes painful blisters and callus on feet and sometimes hands, thickened~     nails, cysts and other features. The IPCRR consists of a questionnaire, patient photos,~     physician notes from telephone consultation to validate questionnaire, free genetic testing.~   "
95196|NCT02321098|"~     The main objective is to compare efficacy, in terms of antifungal activity of Loceryl Nail~     Lacquer associated with a Cosmetic Varnish and Loceryl Nail Lacquer alone, in the treatment~     of mild to moderate toenail Distal Subungual Onychomycosis.~      The second objective of this study will be photographic follow-up of clinical improvement and~     cure after the initial treatment period of 12 weeks, for 15 additional months.~   "
95172|NCT02321410|"~     Atherosclerosis may initiate early in life and takes years to progress. This contrasts to the~     abrupt coronary or cerebrovascular events occurring following the transition from a stable to~     an unstable atherosclerotic plaque. The causes of this discontinuity of the disease are~     complex and probably multiple. There is increasing evidence that, besides inflammation,~     neovascularisation of atherosclerotic plaques and intra-plaque hemorrhages play an important~     role in plaque instability ending-up frequently in acute thrombotic occlusion or distal~     embolisation of athero-thrombotic material associated with heart attack or stroke.~     Contrast-enhanced Ultrasound, is a bed-side non-invasive technique, which allows to enhance~     microvascular structures and to visualize the adventitia and intraplaque vascularization.~     Dynamic contrast-enhanced plaque MRI (DCE-MRI) which has also been evaluated for in vivo~     detection and quantification of plaque neovascularity. Together with the presence of a large~     lipid-rich core, thin fibrous cap, positive remodeling and active inflammatory infiltrate,~     plaque neovascularisation is considered a valid marker of high-risk (or vulnerable) plaque as~     demonstrated in histopathological studies using microvessel density.~      Aim of the study is to assess and validate the value of contrast enhanced ultrasound (CEUS),~     a bed-side technique, in detecting plaque neovascularisation and compare it with the~     quantitative assessment by DCE-MRI in carotis atherosclerosis.~      A group of 30 patients with asymptomatic carotid atherosclerosis (> 50% stenosis on Doppler~     ultrasound) will undergo Carotid Duplex ultrasounds and CEUS. High-resolution plaque MRI and~     DCE-MRI will be performed in the same patients and will be analyzed by two separate operators~     blinded to the results of the CEUS in order to detect the efficacy of CEUS when compared with~     in vivo DCE-MRI, as the standard of reference.~   "
95173|NCT02321397|"~     This study is aimed to demonstrate equivalence between combinations of lower strength OXN PR~     tablets (OXN PR LST) and single higher strength OXN PR tablets (OXN PR HST) taken at the same~     overall daily dose.~   "
95174|NCT02321384|"~     This study is a single-center, double-blind, randomized, placebo-controlled, single-ascending~     dose (SAD) and multiple-ascending dose (MAD) study that will evaluate the safety,~     tolerability and pharmacokinetics (PK) of RO6889678 and the combination of RO6889678 with~     Ritonavir (RTV) following oral administration in healthy volunteers. The effect of food on~     the PK of RO6889678 and the effect of multiple dosing of RO6889678 and the combination of~     RO6889678 with RTV on the PK of a single oral microdose of midazolam will be evaluated.~      Healthy participants will be screened up to 28 days before randomization and sequentially~     enrolled into SAD and MAD unboosted and RTV-boosted cohorts, then randomly assigned to~     RO6889678 or matching placebo. In RTV-boosted cohorts participants will take RO6889678 in~     combination with RTV. To explore the effect of food on RO6889678 PK, a cohort of volunteers~     will participate in a two-period food effect sub-study. Participants enrolled in the MAD~     cohorts will be given an oral microdose of midazolam before and after the repeat treatment~     with RO6889678 to evaluate the drug-drug interaction potential of RO6889678.~   "
95175|NCT02321371|"~     In this study, all patients with ACLF (Acute on Chronic Liver Failure) with grade III/IV HE~     (Hepatic Encephalopathy) getting admitted in our institute will be enrolled after the~     fulfilment of inclusion/exclusion criteria and consent of the patient's attendants.~     Investigation of the patient (as mentioned in the proforma) will be done.~      Intervention step 1:~      liq Lactulose 100 mL stat followed by 30 mL/ hourly through NG/NJ route + Lactulose enema 3rd~     hourly - till 4 time soft stool is passed, then 30 mL through enteral route 6th hourly (If~     patient has no bowel sounds, only enema will be given)~      Intervention step 2:~      (after 24 hours of introduction of step 1, if no rapid reduction in ammonia to <70mcg/dL)~     Randomization to L or R arm R Arm (Addition of Rifaximin) Continuation of Lactulose +~     addition of Rifaximin 400 mg 8th hourly through enteral route L Arm (Lactulose only)~     Continuation of Lactulose therapy for further 48 hours.~   "
95176|NCT02321358|"~     This trial is a three-armed randomized controlled trial which will explore the utility of an~     implementation intention intervention on aerobic and resistance exercise in older (60+)~     prostate and breast cancer survivors and improving quality of life. It is expected that those~     in the experimental groups will report greater increases in their physical activity,~     resulting in greater improvements in their quality of life.~   "
95177|NCT02321345|"~     This is a feasibility study of pre-transplant involvement of a palliative care provider in~     the setting of HCT. Although this is primarily a feasibility pilot, the investigators will~     explore how patients are affected by the palliative care meetings as well as test data~     collection mechanisms that would be used in a future randomized clinical trial.~      The investigators hypothesis is that patients will be amenable to pre-transplant involvement~     of the palliative care team and might welcome the chance to discuss palliative care issues~     separate from the primary team. Palliative care providers also have special training and~     experience in conducting these interactions and expertise in supportive care practices. They~     will be available should a patient's condition become life- threatening. This study is~     therefore designed primarily to evaluate the level of comfort / distress of patients when a~     palliative care consultation and follow-up are integrated into their care.~   "
95178|NCT02321332|"~     Comparison between unilateral sequential and bilateral simultaneous endoscopic thoracic~     sympathectomy for palmar hyperhidrosis on patients outcomes notably compensatory~     hyperhidrosis.~   "
95179|NCT02321319|"~     This pediatric study is designed to provide safety information, dosing guidelines, and a~     pharmacokinetic (PK) evaluation of once-daily hydromorphone hydrochloride (HCl)~     extended-release (ER) tablets in children with chronic painful conditions who are~     opioid-tolerant prior to enrollment under the Pediatric Research Equity Act (PREA) of 2003.~   "
95180|NCT02321306|"~     Open-label, multicenter study in adults with Primary Biliary Cirrhosis (PBC) designed to~     evaluate the long-term safety and tolerability of daily dosing with LUM001.~   "
95181|NCT02321293|"~     The purpose of this study is is to assess the safety and tolerability of curcumin in~     combination with EGFR-TKIs in selected patients with advanced non-resectable mutant EGFR~     NSCLC.~   "
95194|NCT02321124|"~     Connective tissue manipulation (CTM) is a manual reflex therapy, which increases intestinal~     motility by stimulating autonomic nervous system to re-balance the parasympathetic and~     sympathetic functions. However, there is no randomized controlled trial (RCT) regarding the~     efficacy of CTM on constipation. This study was planned to investigate the effects of CTM in~     patients with chronic constipation.~      Patients who have diagnosis of chronic constipation according to Rome III criteria were~     recruited and randomized to intervention and control group. The intervention group received~     CTM in addition to the lifestyle advice, while the control group was given only lifestyle~     advice for constipation. All assessments were performed at baseline and at the end of 4~     weeks. The primary outcome measure was the Constipation Severity Instrument (CSI). Secondary~     outcomes included Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL),~     Bristol Stool Scale (BSS) and 7-day bowel diary. Differences between groups were analyzed~     with t-tests, Mann-Whitney U test and Chi-square test.~   "
95182|NCT02321280|"~     Denosumab, a fully human monoclonal antibody to RANKL was approved for the treatment of~     postmenopausal osteoporosis in June 2010. It is administered subcutaneously once every 6~     months and is highly effective in reducing the risk of vertebral, non-vertebral, and hip~     fracture risk. There are 3 main concepts underpinning the rationale for using Denosumab to~     treat CD.~        1. CD is associated with an increased risk for osteoporosis and the biology of osteoporosis~          and T cell mediated inflammation, thought to be integral in CD, involve the RANKL~          paradigm~        2. Animal models of bone loss and colitis treated with RANKL inhibitors improve both bone~          mass and colitis. A dinitrofluorobenzene sulfonic acid (DNBS) model of colitis in our~          lab showed significant improvement with Denosumab treatment compared to vehicle (saline)~          treatment.~        3. CD is associated with an increase in mutations at the locus that encodes for RANKL The~          investigators are conducting an open label pilot study of single dose Denosumab 120 mg~          s.c. to patients with active Crohn's disease, with assessment of clinical response and~          remission at 12 weeks.~   "
95183|NCT02321267|"~     Macular diseases often cases severe visual impairment. Recent clinical introduction of~     anti-vascular endothelial growth factor agents may change the clinical course of various~     macular diseases, including age-related macular degeneration (AMD), polypoidal choroidal~     vasculopathy (PCV), retinal angiomatous proliferation (RAP), central serous chorioretinopathy~     (CSC), myopic choroidal neovascularization (CNV), retinal vein occlusion (RVO), diabetic~     macular edema (DME), and so forth. The advance in vitrectomy improve visual outcomes in some~     maculae diseases, including epiretinal membrane (ERM), macular hole (MH), vitreomacular~     traction syndrome (VMTS).~      Patients with such macular diseases are registered and are followed up for 5 years with~     appropriate treatment for each patient. By the analysis of the correlation between initial~     examinations and final visual acuity, factors associated with good visual prognosis will be~     elucidated.~   "
95184|NCT02321254|"~     The aim of this study is to assess the clinical effectiveness of the RehaARM-robot and to~     determine the feasibility of including robotic therapy in daily rehabilitation programmes,~     after stroke. Additionally, we aim to investigate the acceptance of this intervention from~     patients and therapists. A total of 10 patients will be recruited in this study, all the~     patients will receive 1 hour of standard therapy together with 45 min of robot therapy every~     day. The robot therapy will last 45 minutes, for 15 consecutive days within a maximum period~     of four weeks. Additional 15 minutes are required for placing surface electrodes on the~     shoulder and patient preparation. The study will include passive and active shoulder training~     of four movements: Horizontal abduction/adduction, abduction/adduction, internal/external~     rotation and flexion/extension. The passive part lasts 10 minutes and the active part 35~     minutes.~   "
95185|NCT02321241|"~     The aim of the TITAN study is to describe the clinical practices of a cohort of patients with~     wAMD refractory to ranibizumab (persistence of intra-retinal and/or subretinal fluid) who~     switch to aflibercept after less than 12 months of ranibizumab treatment.~      The study will be conducted in real-life conditions and will allow describing conditions of~     use of aflibercept in patients refractory to ranibizumab~   "
95186|NCT02321228|"~     The purpose of this study is to determine whether an innovative preventive strategy,~     consisting of early salpingectomy upon completion of childbearing with delayed oophorectomy~     beyond current guideline age, improves menopause-related quality of life without~     significantly increasing ovarian cancer incidence in comparison to current standard~     salpingo-oophorectomy in female BRCA1/2 mutation carriers.~   "
95187|NCT02321215|"~     The purpose of this study is to determine if it is effective and feasible to provide a~     chronic obstructive pulmonary disease (COPD) education program to patients admitted with an~     acute exacerbation of COPD.~   "
95188|NCT02321202|"~     The safety and efficacy of ω-3 fatty acid in patients with liver cancer followed hepatectomy~     is not known. This study provided evidences that ω-3 fatty acid-based parenteral nutrition~     improved postoperative recovery for cirrhotic patients with liver cancer underwent~     hepatectomy..~   "
95189|NCT02321189|"~     Choroidal thickness represents blood-flowing of eyes. The investigators detect the choroidal~     thickness of the young participant using SD-OCT to see the effect of Resveratrol Based~     Nutritional Supplement on Choroidal Thickness.~   "
95190|NCT02321176|"~     There is blood-eye barrier in eyes,but some oral medicines can enter in the tissues of eyes.~      The primary objective of the study is to study the Pharmacokinetics of Trans-resveratrol and~     Its three Metabolites in Human Eyes and Blood~   "
95191|NCT02321163|"~     Objectives: This study aims to examine the use of low frequency (2Hz), low amplitude~     (intensity just produce visible muscle contraction), and long duration (2x3 hrs/day)~     neuromuscular electrical simulation (NMES) in attenuating the effects of muscle atrophy~     resulted from disuse.~      Design and subjects: The study is a randomized, double-blind, controlled, and parallel group~     study. Subjects with stable chronic obstructive pulmonary disease (COPD) will be included.~     Intervention: Subjects will be randomized to 3 groups to receive different NMES program over~     the quadriceps and calf muscles: (i) the proposed NMES program; (ii) conventional NMES~     program (50Hz, 30 min/day), or sham group for a period of 8 weeks.~      Outcome measures:The effectiveness of the NMES will be evaluated by the improvement in muscle~     cross-sectional area (CSA), muscle performance (muscle strength, muscle shortening velocity~     and muscle activation testing), functional performance (6 min walk) and subjects' rating of~     the perceived acceptability of the stimulation protocol.~      Data analysis: Baseline characteristics of the intervention and sham groups will be compared~     using one way ANOVA. Two-way mixed repeated measures analysis of variance will be performed~     to examine the differences between groups over time for all the outcome variables. The~     significance level is set at p < 0.05.~      Expected results: The investigators hypothesize that the proposed new paradigm of NMES would~     be more effective in improving muscle cross-sectional area (CSA), strength, endurance, and~     exercise tolerance.~   "
95192|NCT02321150|"~     The aim of this study is to introduce a new surgical technique for the removal of pterygiums~     that entails the use of bipolar electrocautery to secure the graft, rather than sutures.~      With this, the objective is to evaluate the benefits of a new technique for pterygium surgery~     with respect to postoperative patient comfort, surgery time, cost and recurrence rate.~   "
95195|NCT02321111|"~     The purpose of this study is to determine whether pharmacologic inhibition of Toll-like~     receptor 4 (TLR4) with eritoran for injection (E5564) prevents lipid-induced insulin~     resistance in lean, normal glucose tolerant (NGT) subjects.~   "
95197|NCT02321085|"~     Prospective randomized (rhythm control or rate control in heart failure patients with new~     onset atrial fibrillation) Objective of study 1. To analyze long term outcome of patients~     with heart failure with new onset atrial fibrillation according to the rhythm control 2. To~     analyze remodeling of atrium and ventricle by the new onset AF in heart failure patients 3.~     To analyze the change of LV function and functional capacity according to the rhythm in~     patients with HF and new onset AF~   "
95198|NCT02321072|"~     Objectives:~        1. To study the short- and long-term effect of two different PaO2 targets on circulatory~          status, organ dysfunction and outcome in patient admitted to the ICU with Systemic~          Inflammatory Response Syndrome (SIRS) criteria.~        2. To study underlying mechanisms of hyperoxia by determining differences in oxidative~          stress response between the hyperoxic and the normoxic patients.~      Study design:~      Randomized, prospective multicentre clinical trial~      Study population:~      Patients admitted to the Intensive Care unit with ≥ 2 positive SIRS-criteria and an expected~     ICU stay of more than 48 hours~      Intervention:~      Group 1: target PaO2 120 (105 - 135) mmHg (high-normal)~      Group 2: target PaO2 75 (60 - 90) mmHg (low-normal)~      Primary endpoints:~      The primary endpoint will be cumulative daily delta SOFA score (CDDS) from day 1 to day 14.~   "
95199|NCT02321059|"~     Patients with an incisional hernia in the midline and controls with an intact abdominal wall~     are examined twice with one week apart, in order to establish the test-retest reliability and~     internal and external validity of the Goodstrength trunk dynamometer.~   "
95200|NCT02321046|"~     This is a multicentre, non-interventional, prospective study to be carried out in~     representative oncology departments / institutions in order to determine the prevalence of~     EGFR mutations in treatment-naive Russian patients with cytologically verified advanced NSCLC~     in Russia.~   "
95201|NCT02321033|"~     Aim of the study is to investigate the impact of glycemic index (provided as soft drinks) on~     changes in insulin sensitivity, metabolic flexibility, and arterial stiffness in response to~     detraining.~      The investigators hypothesize that low glycemic soft drinks decrease the detraining-induced~     impairment of insulin sensitivity, metabolic flexibility and arterial stiffness.~   "
95202|NCT02321020|"~     The present study aimed at evaluating mid-term results of radiofrequency modified maze~     procedure in mitral patients in terms of sinus rhythm and atrial contractility restoration~   "
95203|NCT02321007|"~     The purpose of this study is to establish a tissue and data repository consisting of samples~     of human placentas, umbilical cord blood, and maternal blood, collected at the time of~     delivery. Specimens will be used in cellular, molecular, and functional studies to learn more~     about changes in placental structure and function, which can result in serious pregnancy~     complications and determine life-long health by programming the fetus for future metabolic~     and cardiovascular disease.~   "
95204|NCT02320994|"~     In this first step of the study the investigators will assess the needs, disease burden and~     current treatments of long-term stroke patients (phase MAS-I).~      The ultimate aim of the complete MAS project (MAS I, II & III) is the development of a model~     of stroke aftercare delivery that can be evaluated to estimate effects in both our local and~     the wider stroke population.~   "
95205|NCT02320981|"~     Our hypothesis is that patients with GERD and/or Eosinophilic Esophagitis (EE) have lower~     esophageal impedance measurements when compared to patients who do not have GERD or EE.~   "
95206|NCT02320968|"~     This study is designed to determine if the addition of the MedclineTM Sleep Assist Device~     will decrease night-time gastroesophageal reflux disease events.~   "
95207|NCT02320955|"~     The complications after reimplantation of cryoconserved autologous bone flaps are reported~     inhomogeniously in the literature. Especially the incidence of bone flap resorption varies~     from 0% to about 30%. More recent retrospective studies seem to find higher resorption rates~     and thus suggest to implant artificial bone replacements from the start. The Swiss~     Prospective Autologous bone Resorption Study is the first propspective observational study~     designed to determine the true incidence of autologous bone resorption.~   "
95208|NCT02320942|"~     This study is a preliminary study to assess whether it is possible to introduce an exercise~     program for BMT patients after discharge from hospital. The exercise program will include 3~     endurance (stationary bike, walking) and 2 resistance (weights, stretch bands) training~     sessions/week, until 100 days after BMT. Our second plan is to test changes in QoL, aerobic~     fitness, muscle strength, total body fat and mineral composition, and blood immune markers~     with exercise in the 100 days after BMT. The investigators anticipate this study will improve~     the QoL, mobility, and strength of patients after BMT, therefore allowing a faster and~     healthier recovery.~   "
95209|NCT02320929|"~     This study evaluates the effect of postoperative intermittent closed-catheter irrigation on~     the recovery from the purulent flexor tenosynovitis. One group of patients suffering from~     acute purulent flexor tenosynovitis is treated using intraoperative irrigation only and the~     other group having both intra- and postoperative irrigation.~   "
95210|NCT02320916|"~     Arterial blood-gas (ABG) measurements are the gold standard to evaluate pulmonary gas~     exchange. However, arterial punctures are more painful than venous punctures and, in ICU~     patients, cause greater anxiety than tracheal aspiration. The only technique that has been~     shown to effectively reduce pain during arterial punctures is the subcutaneous injection of~     lidocaine. However, this technique is more time consuming and is poorly used.~      Topical anesthesia is widely used during arterial punctures despite the lack of proof of~     efficacy.~      While performing arterial punctures with small gauge needles is feasible, to the best of the~     investigators knowledge no studies have assessed the effect of needle gauge on arterial~     puncture related pain.~      The aim of the present study was to compare the pain experienced during arterial punctures~     performed with a 25 G or 23 G needle. The secondary endpoints were the characterization of~     the pain and the anxiety associated with the arterial punctures.~   "
95223|NCT02320747|"~     Tai Chi has been widely practiced as a Chinese martial art that focuses on slow sequential~     movements, providing a smooth, continuous and low intensity activity. It has been promoted to~     improve balance and strength and to reduce falls in the elderly, especially those 'at risk'.~     The potential benefits in healthy younger age cohorts and for wider aspects of health have~     received less attention.~      The present study documented prospective changes in balance and vascular responses for a~     community sample of adults.~   "
95211|NCT02320903|"~     The goal of the current trial is to assess the feasibility of a newly developed prototype of~     a cell phone app called VillageWhere. VillageWhere is designed to improve clinical outcomes~     of youth with externalizing behavioral problems by improving parental monitoring of youth~     whereabouts and activities while increasing the delivery of rewards to teens for good~     behavior. This Phase I Small Business Innovation Research (SBIR) proposal seeks to develop~     and conduct initial feasibility testing of the VillageWhere prototype. The primary features~     of the prototype include location monitoring via smartphones' global positioning system (GPS)~     functionality as well as facilitating teen self-appraisal of meeting behavioral expectations.~     Good behavior is rewarded with points that are tracked by the app and can be used to redeem~     for real-world rewards. The investigators will conduct an 45-day open trial (N=20~     caregiver/teen dyads) to assess use, feasibility and acceptability for teens involved in the~     juvenile justice system or otherwise struggling with externalizing behavioral problems.~     Caregivers and teens will be assessed at baseline, before receiving the app, and at the end~     of the app use period (45 days). The therapist of each caregiver/teen dyad will also be~     assessed at the end of the app use period. Primary outcomes include: use of app features,~     monitoring of teen behavior and whereabouts, delivery of real-world rewards, and feasibility~     and acceptability. Secondary outcomes include: parenting behaviors, externalizing teen~     behaviors and internalizing teen behaviors.~   "
95212|NCT02320890|"~     The primary objective of this study is to investigate whether the transcranial direct current~     stimulation (tDCS) improves the cognitive function in patients with Mild Cognitive Impairment~     (MCI)~   "
95213|NCT02320877|"~     In this prospective trial 50 patients, diagnosed with moderate to severe obstructive sleep~     apnea (OSA) (AHI > 15/h sleep) will be included and treated with mandibular advancement~     devices (MAD). These patients will undergo cardiovascular examination; echocardiography and~     24h-blood pressure monitoring, on top of the normal clinical evaluation of OSA patients.~     These cardiovascular examinations will take place before and during MAD therapy.~   "
95214|NCT02320864|"~     To evaluate operational aspects of studying pre to post surgery/hospitalization changes in~     the integrity of a major white matter pathways and how these contribute to reductions in the~     ability to produce forceful muscle contractions.~   "
95215|NCT02320851|"~     The purpose of this study is to evaluate the efficacy of a manualised, multimodal group~     psychotherapy, based on integrative psychotherapy (IPT) and tailored to somatoform~     vertigo/dizziness (SVD) subgroups of mental disorders, compared to self-help groups (SHGs) in~     patients with SVD. The investigators hypothesise that patients who received IPT will~     demonstrate greater improvement concerning their vertigo-related handicap compared to~     patients from the SHGs. The investigators will also analyse the cost-effectiveness of~     experimental and control intervention.~   "
95216|NCT02320838|"~     The purpose of this study is to determine whether the transcutaneous application of~     unmodulated 5 Kilohertz (KHz) alternating currents are effective in decreasing the thermal~     and mechanical experimental pain and cause changes in peripheral nerve conduction. Moreover~     evidence whether the effect and comfort of this current is greater than Conventional TENS~     (Transcutaneous Electrical Nerve Stimulation) commonly used for the treatment of clinical~     pain.~   "
95217|NCT02320825|"~     The purpose of this study is to find out whether giving one higher dose of radiation is as~     good at treating the tumor in the patient's spine after surgery as giving three lower doses~     of radiation.~   "
95218|NCT02320812|"~     This study evaluates the safety and potential activity of a single dose of live human retinal~     progenitor cells (jCell) administered to adults with retinitis pigmentosa. Two different dose~     levels of cells will be assessed in each of two groups of patients.~   "
95219|NCT02320799|"~     The aim of this study is to conduct a 12-week IPT+TAU versus wait list TAU in a cohort of~     HIV+GBV+ women in Nyanza Province to relieve depression and PTSD and improve ARV adherence.~     This pilot study will provide data on the efficacy trends, acceptability and feasibility of~     our IPT intervention and will generate preliminary findings for an R01-funded intervention to~     test the intervention's efficacy for remediating the effects of GBV trauma on mental health~     and HIV-related outcomes.~      Hypothesis 1: IPT+ TAU will be more effective for reduction of depression and PTSD than TAU~     alone.~      Hypothesis 2: IPT+TAU will be acceptable and feasible.~   "
95220|NCT02320786|"~     Losing the ability to walk can lead to fewer opportunities to socialize with friends and~     family and participate in the community. When this happens, powered wheelchairs can provide~     access to homes and communities, contributing to health and well-being. Training by a~     qualified occupational therapist allows an individual to use a powered wheelchair safely and~     effectively. Learning to drive a powered wheelchair can be difficult, frustrating and time~     consuming for people with cognitive and physical challenges. In this study, we will ask~     participants with cognitive impairments to complete training with an occupational therapist~     using either a shared control wheelchair or training methods according to the standard of~     care. We believe shared control training, entitled Collaborative Powered mobility Innovative~     Learning OpporTunity (CoPILOT) will enhance driving skill while maximizing safety learning.~     CoPILOT has the potential to enable people to participate more in their day to day lives and~     regain mobility independence.~   "
95221|NCT02320773|"~     A study to understand the impact of Betmiga® on patients quality of life, satisfaction with~     treatment, how long patients remain on treatment, patterns of healthcare resource~     utilisation, and safety as prescribed by the physicians in routine clinical practice.~   "
95222|NCT02320760|"~     This randomized controlled study evaluates the effect of individualized physical activity on~     prescription (PAP) in older overweight adults. The primary hypothesis is that an~     individualized prescription of physical activity increases physical activity level in~     overweight older adults after 6 months. Secondary hypothesis are that the increased physical~     activity level will improve cardio metabolic risk factors and quality of life.~      200 women and men, aged 65 with low physical activity level, overweight, and abdominal~     obesity, will be randomized to an intervention group or a control group. The control group~     receives general information about physical activity and registration of physical activity~     level for one week. The intervention group receives in addition an individualized physical~     activity on prescription with patient-centered counseling.~      After six months both groups go through the same health check-up as at baseline and~     follow-ups take place after 12 and 24 months.~   "
95224|NCT02320734|"~     Rationale: Endoscopic (thoraco-laparoscopic) esophageal surgery is a high risk procedure~     where the use of deep neuromuscular block (NMB) may increase field visibility and anaesthesia~     conditions. Under these conditions, boluses of muscle relaxants can be given on indication~     only OR by continuous infusion. We hypothesize that deep NMB by continuous infusion of~     rocuronium as compared to on demand bolus administration facilitates surgical and anesthesia~     conditions during thoraco-laparoscopic esophageal resection but higher doses of sugammadex~     are needed to reverse NMB at the end of surgery.~      Objective: Primary objective is to evaluate the use of deep muscle relaxation versus on~     indication only on surgical and anesthesia conditions in patients for endoscopic esophageal~     resection. Secondary objectives are to evaluate the (hypothetical) dose of sugammadex needed~     in both groups in an economical perspective and to compare the intra-operative cardiac and~     respiratory incidents and post-operative complication rate of both groups.~      Study design: a single-center randomized controlled double-blinded intervention study.~      Study population: All patients > 18 years to undergo a thoracolaparoscopic esophageal~     resection.I Intervention: Patients are randomized to receive either continuous infusion of~     rocuronium 0.6 mg/kg/hr (group 1) or continuous infusion of NaCl 0.9% 0.06 ml/kg/hr (group~     2). On demand boluses of Rocuronium 0.3 mg/kg can be given in both groups.~      Main study parameters/endpoints: The primary outcome parameter of this study is the SRS~     during the abdominal phase of thoracolaparoscopic esophageal surgery. Secondary outcomes~     measured are SRS during the thoracic phase, the number of on demand boluses infused, the dose~     of Sugammadex needed in both groups to reach a TOF of > 90%, duration of surgery, a~     cost-analysis, the incidence of intra-operative cardiac and respiratory incidents and the~     ability of surgeons to estimate which neuromuscular blocking regime was given to the patient.~   "
95225|NCT02320721|"~     Primary Objective:~      To demonstrate the non-inferiority of H0E901-U300 to Lantus, in change of glycated hemoglobin~     A1c (HbA1c).~      Secondary Objectives:~      To demonstrate the superiority of H0E901-U300 in comparison with Lantus in:~        -  Percentage of participants with at least one severe and/or confirmed (by plasma glucose~          ≤70mg/dL [3.9mmol/L]) hypoglycemia event from 22:00 to 08:59 next morning~        -  Percentage of participants with at least one nocturnal (from 00:00-05:59) severe and/or~          confirmed (≤70mg/dL [3.9mmol/L]) hypoglycemia event~        -  Percentage of participants with at least one severe and/or confirmed (by plasma glucose~          ≤70mg/dL [3.9mmol/L]) hypoglycemia event occurring at any time of day~        -  HbA1c change~   "
95226|NCT02320708|"~     This is a dental pain study evaluating the efficacy and safety of a single dose of test~     acetaminophen (ACE) (1000 mg) compared to commercial acetaminophen (1000 mg), ibuprofen (IBU)~     (400 mg), and placebo over a 6 hour period. Subjects will undergo dental extraction of three~     or four third molars.~   "
95227|NCT02320695|"~     The purpose of this study is to have subjects report whether or not several antibiotic~     products sting when they are applied to minor wounds created on the inner arms.~   "
95228|NCT02320682|"~     What is the intensity of F-PET uptake adjacent to four analyzed hip endoprosthetic components~     and in healthy femur and acetabulum, 1, 4 and 9 months after surgery?~   "
95229|NCT02320669|"~     This is a study to determine the safety and efficacy of liothyronine sodium/triiodothyronine~     (Triostat), a synthetic thyroid hormone, when given to infants with congenital heart disease~     during cardiopulmonary bypass surgery. Funding Source - FDA OOPD.~   "
95230|NCT02320656|"~     HEMATO-BIO-IPC-2013-015 is a monocenter prospective longitudinal study. Our aim is to define~     predictive clinical and biological factors in acute leukemia, myelodysplastic syndromes and~     myeloproliferative disorders by using genomics, genetics and epigenetics, in vitro and in~     vivo drug sensitivity studies,and translational immonulogy and immunomonitoring studies.~      HEMATO-BIO primary outcome measure is to identify molecular, genomic and epigenetic,~     pharmacologic and immunophenotypic alteration in acute leukemia, myelodysplastic syndromes~     and myeloproliferative disorders by collecting, at diagnosis and/or complete remission and/or~     relapse:~        -  tumor samples: marrow aspiration, blood sampling.~        -  non-tumor samples: skin biopsy, buccal swab . from 360 patients treated at our cancer~          center.~   "
95231|NCT02320643|"~     The purpose of this study is to evaluate the efficacy, recurrence, postoperative~     complications of partially absorbable mesh(Seratom®PA) in patients with pelvic organ~     prolapse.~   "
95232|NCT02320630|"~     This trial aims to compare the cost effective and effect of preventing recurrence by~     different treatment of TFP and HCQ combined SSZ for remittent RA.~   "
95233|NCT02320617|"~     The purpose of this study is to investigate the diagnostic accuracy of ADC value of diffusion~     weighted MRI in comparison of conventional treatment assessment criteria in evaluation of~     chemotherapy. Moreover, the investigators aim to clarify the correlation of ADC value with~     histologic type and grade of lung cancer and survival of patients.~   "
95234|NCT02320604|"~     Dosing guidelines for liposomal amphotericin B (AmBisome) in (morbidly) obese patients are~     not available. Subsequently, the pharmacokinetic profile of AmBisome in this specific patient~     population is still largely unknown.~      To build a valid pharmacokinetic model, obese patients with a BMI ≥ 40 undergoing endoscopic~     gastric bypass surgery will receive a single dose of 1 mg/kg or 2 mg/kg AmBisome (besides~     standard anti-bacterial prophylaxis) and a PK-curve will be drawn. These PK-values can then~     be compared to the pharmacokinetics of a normal-weight group.~   "
95235|NCT02320591|"~     This study assesses the effects of the Centers for Medicare and Medicaid Services'~     Comprehensive Primary Care (CPC) initiative on physician practices, practice staff, Medicare~     and Medicaid costs and service utilization, quality of care, and patient outcomes. CPC~     provides financial resources, timely feedback on key practice outcomes, and a learning~     network to support practice transformation to improve quality of care and lower costs.~   "
95236|NCT02320578|"~     The aim of this prospective randomized pilot study is to verify if the operative time of a~     Radical abdominal hysterectomy (LRH) with pelvic lymphadenectomy for early stage cervical~     cancer (FIGO stages IA2-IB1-IIA<2cm) and for advanced stage cervical cancer (FIGO stages~     IB2-IIA>2cm-IIB) submitted to neoadjuvant chemotherapy (NACT) with complete clinical response~     could be further reduced using 3D Laparoscopy (Olympus Medical Systems Corp) versus standard~     laparoscopy~   "
95237|NCT02320565|"~     This prospective randomized pilot study is aimed to verify if the operative time of a total~     laparoscopical hysterectomy (TLH) with pelvic lymphadenectomy for endometrial cancer FIGO~     stage IB-II could be reduced using 3D laparoscopy versus standard laparoscopy~   "
95238|NCT02320552|"~     The purpose of this study is to determine the prevalence of protein-energy wasting and~     obesity among Danish dialysis patients.~   "
95239|NCT02320539|"~     The purpose of this study is to validate results from a related trial (NCT01791257) and to~     compare the profile of microRNA in blood from patients suffering subarachnoid hemorrhage with~     and without systemic complications.~   "
95265|NCT02320201|"~     To determine the effects of electrical stimulation of the nerves in the foot on overactive~     bladder conditions in children.~   "
95240|NCT02320526|"~     Interval training is superior to continuous training for improving glycemic control,~     hereunder glycemic variability and -spikes. However, the underlying mechanisms and the~     clinical impact is at present unknown.~      The overall objective of this project is to determine the mechanisms underlying aeroic~     interval-training-induced reductions in glycemic variability and -spikes, and the impact on~     levels of systemic inflammation in type 2 diabetes patients. It is hypothesized that aerobic~     interval training reduces glycemic variability and -spikes more than continuous training due~     to larger improvements in both peripheral insulin sensitivity and the mass action effect of~     glucose. Moreover, it is hypothesized that these reductions in glycemic variability and~     -spikes also reduces systemic inflammation.~   "
95241|NCT02320513|"~     This is a pilot study intended to gather data in order to inform future studies about the~     role of feedback as an incentive for increasing levels of physical activity which could~     improve health in hemodialysis patients.~   "
95242|NCT02320500|"~     Patients with chronic knee pain attributed to osteoarthritis and referred to orthopedics as~     potential candidates for a knee replacement will receive standard physiotherapy or~     myofascial-specific therapy over 8 weeks. Based on the investigators pilot investigation, the~     investigators expect those who receive myofascial-specific therapy to experience reduced pain~     (compared to the standard therapy group) and increased flexibility compared to baseline~     levels. This simple conservative therapy could postpone (or in some cases, eliminate) the~     need for a knee replacement since pain is the major indication for surgery. If successful,~     this treatment could improve the quality of life and increase productivity for thousands~     suffering from knee osteoarthritis and preserve valuable health care resources.~   "
95243|NCT02320487|"~     This is a Phase 2, open-label, multicenter study to evaluate the safety and efficacy of BG~     induction therapy in participants with previously untreated CLL. The anticipated time on~     study treatment is 24 weeks.~   "
95244|NCT02320474|"~     This is a one-year pilot, interventional, prospective, single arm, non-randomized,~     multicentric (3 centers) controlled study that aims to evaluate the response of type 3~     choroidal neovascularization to treatment by Aflibercept following a classic protocol.~   "
95245|NCT02320461|"~     The Brazilian Longitudinal Study of Adult Health (ELSA-Brasil) aims to contribute with~     relevant information regarding the development and progression of clinical and subclinical~     chronic diseases, particularly cardiovascular diseases and diabetes. The investigators~     enrolled 15,105 civil servants from predefined universities or research institutes. Baseline~     assessment (2008-2010) included detailed interviews and measurements to assess social and~     biological determinants of health, as well as various clinical and subclinical conditions~     related to diabetes, cardiovascular diseases and mental health. For the ascertainment of~     incident events, annual telephone surveillance is being conducted since 2009, and a second~     visit of interviews and exams is under way (2012-2014). Long-term biological sample storage~     is provided for sera, plasma, urine and DNA. Baseline data is available for analyses, and~     collaboration via specific research proposals directed to study investigators is welcome.~      This multicenter study is chaired by a steering committee, made up of the coordinators and~     vice-coordinators of each of the six centers. No individual center coordinates the study. The~     six institutions listed in the contact details all sponsor the study.~   "
95246|NCT02320448|"~     This is a feasibility study that aims to evaluate whether PIPAC (Pressurized Intraperitoneal~     Aerosol Chemotherapy) is a safe and feasible treatment in Danish patients with peritoneal~     cancer.~   "
95247|NCT02320435|"~     This is a single-arm, multi-center, open-label extension study designed to provide pertuzumab~     to patients who continue to derive benefit from pertuzumab, as well as to collect long-term~     safety and efficacy data of pertuzumab therapy. Patients receiving pertuzumab as an~     investigational medicinal product (IMP) in a Roche-sponsored Global study who continue to~     receive pertuzumab at the time of the Parent study end are eligible for continued treatment~     in this extension study. Patients with solid tumors who have not experienced progressive~     disease in the Parent study and, in the Investigator's opinion, may potentially benefit from~     continued Perjeta treatment will continue to receive pertuzumab until disease progression,~     unacceptable toxicities, Investigator decision, patient non-compliance, patient death,~     patient request to withdraw, or study termination by the Sponsor.~   "
95248|NCT02320422|"~     The purpose of this study is to pilot-test a tailored telemetric intervention to improve~     adherence to medications in adults who had a liver transplant and are presently non-adherent~     (as measured by tacrolimus levels).~   "
95249|NCT02320409|"~     The purpose of this study is to evaluate to determine the effect of food on the PK of a~     single dose of 250 mg Sufatinib and its metabolites in healthy subjects.~   "
95250|NCT02320396|"~     This is an efficacy and safety study of desloratadine (MK-4117) in Japanese participants with~     seasonal allergic rhinitis (SAR). The primary hypothesis of this study is that the change~     from Baseline in Total Nasal Symptom Score (TNSS) is improved by desloratadine compared to~     placebo.~   "
95251|NCT02320383|"~     A Prospective, Multicenter, Randomized Phase-Ii Trial Comparing Efficacy And Safety Of~     Fludarabine + Cyclophosphamide + Ga101 (Fcg) And Bendamustine + Ga101 (Bg) In Patients With~     Relapsed Or Refractory Cll Followed By Maintenance Therapy With Ga101 For Responding Patients~   "
95252|NCT02320370|"~     The investigators examine the efficacy of two different transcranial direct current~     stimulation (tDCS) stimulation protocols in the treatment of acute anxiety in an open-label~     pilot study in patients who have faced severely stressful life events.~   "
95253|NCT02320357|"~     CD40 Ligand (CD40L) has been identified as a key feature in systemic lupus erythematosus~     (SLE) pathogenesis, a systemic autoimmune disease characterized by a multiorgan involvement.~     As platelets are a major source of soluble CD40L (sCD40L), we propose to study the effect of~     clopidogrel, a platelet inhibitor, on plasmatic sCD40L levels in SLE patients.~   "
95266|NCT02320188|"~     The purpose of the study is to determine in a randomized controlled trial (RCT), the efficacy~     of eccentric exercise training in restoring muscle mass and function in patients with~     rheumatoid cachexia.~   "
95453|NCT02317731|"~     The purpose of this study is to determine whether patients drinking their bowel preparation~     solution with a straw will have improved tolerability for ingestion of their bowel~     preparation solution and achieve a higher bowel preparation quality score than patients~     drinking their bowel preparation solution without a straw.~   "
95254|NCT02320344|"~     The 3-month face-to-face Partners in Care intervention will be community-based and~     community-led by trained community peer educators from these four partnering community~     organizations. The intervention involves 12 weekly, group lessons with each lesson lasting~     about 1 and 1/2 hours. Individuals with a hemoglobin A1c (HbA1c; average blood sugar levels)~     greater than or equal to 7% will be recruited for the study because they represent the most~     at-risk for diabetes-related complications. Over a 3-year accrual period, the community~     partners will recruit and enroll 150 eligible NHs and PPs, as well as deliver and evaluate~     the intervention in their respective community settings. The primary outcomes of our study~     are hemoglobin A1c and self-reported diabetes specific quality of life. Secondary outcomes~     are cholesterol levels (including HDL, LDL, total cholesterol, and triglycerides), blood~     pressure, body mass index, and psychosocial adaptation.~   "
95255|NCT02320331|"~     The purpose of the OHA PILI 'Ohana Project is to disseminate and evaluate the effectiveness~     of a community-based intervention (PILI 'Ohana Intervention Program) aimed at eliminating~     obesity in Pacific Peoples across the four islands. Dissemination will involve implementation~     of the program in eight communities through partnerships with nine different community-based~     organizations serving those areas (four founding community partners and five new community~     partners). These organizations provide services to a large number of Pacific Peoples,~     including (but not limited to) Native Hawaiians, Samoans, Filipinos, and Chuukese.~      The main aims are to: (1) train five additional community organizations and their staff to~     deliver the PILI 'Ohana Intervention Program, (2) to enroll 150 overweight/obese participants~     across 8 different communities and four different islands into the intervention program, and~     (3) to evaluate the effectiveness of the program in reducing weight/BMI by at least 3% of the~     participant's initial weight.~      The PILI 'Ohana Intervention is a 9-month lifestyle intervention focusing on individual~     health behaviors in the context of family and community environments and in the~     socio-cultural context of Pacific Peoples. In order to increase the likelihood that an~     organization will implement the PLP, they will be able to adapt the intervention and~     participant assessments. The POP will provide guidance on adaption of the intervention and~     assessments at the training (CHS #21680). What is described below is the maximum amount of~     contact and assessment procedures that participants will undergo. Therefore, organizations~     may change the timing of the 14 lessons and refrain from using all the assessment procedures,~     but will still provide the 14 lessons and offer the same incentives to participants for~     assessments.~   "
95256|NCT02320318|"~     Irritable Bowel Syndrome with diarrhoea (IBS-D) is a functional gastrointestinal disorder~     characterised by chronic or recurrent abdominal pain or discomfort and diarrhoea. The aim of~     this trial is the evaluation of the efficacy and safety of oral ibodutant 10 mg once daily as~     compared to placebo in women with IBS-D over a 12-week treatment period.~   "
95257|NCT02320305|"~     This randomized pilot clinical trial studies melanoma antigen recognized by T-cells 1~     (MART-1) antigen with or without toll-like receptor 4 (TLR4) agonist glucopyranosyl lipid~     A-stable oil-in-water emulsion (GLA-SE) in treating patients with stage II-IV melanoma that~     has been removed by surgery. Vaccines made from MART-1a peptide or antigen may help the body~     build an effective immune response to kill tumor cells. Giving TLR4 agonist GLA-SE with~     MART-1 antigen may help increase the immune response to MART-1a antigen.~   "
95258|NCT02320292|"~     This randomized phase III trial studies rituximab and yttrium Y-90 ibritumomab tiuxetan to~     see how well they work compared to rituximab alone in treating patients with untreated~     follicular lymphoma. Monoclonal antibodies, such as rituximab, may find cancer cells and help~     kill them. Radioactive substances linked to monoclonal antibodies can bind to cancer cells~     and give off radiation which may help kill cancer cells. It is not yet known whether~     rituximab works better with or without yttrium Y-90 ibritumomab tiuxetan in treating~     follicular lymphoma.~   "
95259|NCT02320279|"~     The objective is to contribute data to ongoing research activities focused on identification~     of EKG waveform changes in the context of clinical conditions and maternal medication use.~     Additionally, to develop the capacity to measure contractions more accurately and more~     reliably using skin-surface electrodes.~   "
95260|NCT02320266|"~     Deep brain stimulation (DBS) is an FDA approved, and widely used method for treating the~     motor symptoms of Parkinson's disease (PD), Essential Tremor (ET), Dystonia and Obsessive~     Compulsive disorder (OCD). Over 100,000 patients worldwide have now been implanted with DBS~     devices. Current approved methods to locate the DBS target regions in the brain use a~     combination of stereotactic imaging techniques and measurements of the electrical activity of~     brain cells. As part of the standard clinical technique, electrical data are collected from~     individual nerve cells. The target brain region emits unique electrical signals. At certain~     brain locations, during DBS surgery, additional electrical data that are generated in~     response to sound will be collected. Regions of the brain that have a decreased response to~     repeated sound (auditory gating) may be important DBS targets for improving thinking. The~     aims are (i) during DBS surgery, in addition to EEG, use microelectrodes in the brain to find~     brain regions, along the normal path to the DBS target, where auditory gating occurs and then~     (ii) determine if stimulation of the identified region(s) alters auditory gating measured by~     EEG. Also an additional aim (iii) is to measure electrical activity at the scalp with EEG to~     characterize auditory gating in patients before and after DBS surgery and also a healthy~     control population.~   "
95261|NCT02320253|"~     The goal of this project is to translate the Look AHEAD intensive lifestyle intervention for~     type 2 diabetes and obesity into usual care at community health centers, comparing an~     in-person group program (IP), a telephone conference call (TCC) group program, and referral~     to medical nutrition therapy (MNT), the current standard of care.~   "
95262|NCT02320240|"~     The purpose of this study is to determine if there is an excess risk of acute kidney injury~     (AKI) with Serotonin-norepinephrine reuptake inhibitors (SNRIs) as compared to Selective~     serotonin reuptake inhibitors (SSRIs), two classes of medication used for the treatment of~     depression.~   "
95263|NCT02320227|"~     To evaluate the safety of a personal lubricant when used as indicated as a personal lubricant~     in the vagina and vulvar/perineal areas at least four times weekly for two weeks in a~     population of healthy females~   "
95264|NCT02320214|"~     To evaluate the safety of Miami w/ frag Personal lubricant when used as indicated as a~     personal lubricant in the vagina and vulvar/perineal areas at least four times weekly for two~     weeks in a population of healthy females.~   "
95267|NCT02320175|"~     The investigators propose implementing a bundle of communication interventions - Patient and~     Family-Centered I-PASS - to improve the quality of information exchange between physicians,~     nurses, and families, and to better integrate families into all aspects of daily decision~     making in hospitals. The investigators believe that doing so has the potential to~     substantially improve both patient safety and patient and family experience.~      The specific aims of the project are - To test the hypothesis that a) rates of serious~     medical errors (including both preventable adverse events and near misses), determined both~     by an established, systematic daily hospital surveillance methodology (primary outcome) and~     family reports (secondary outcome); as well as b) poor verbal handoffs during family centered~     rounds (FCRs - assessed through direct observation - secondary outcome); rates of discordant~     understanding of the care plan between healthcare providers and families (assessed through~     survey instruments - secondary outcome); and rates of family (primary outcome) and nurse and~     physician dissatisfaction (secondary outcomes) will decrease following implementation of~     Family-Centered I-PASS, as compared with current practice.~   "
95268|NCT02320162|"~     The aim of this project was to compare the effectiveness of experiential learning (EL) and~     traditional lecturing (TL) school-based oral health education on the oral health knowledge,~     attitude, habits, oral hygiene, gingival health and caries incidence of 10 and 13-year-old~     Greek children. Thee hundred and fifty children were selected from three areas of Greece.~     Information on oral health knowledge, attitude and behaviour were obtained using a~     questionnaire. Dental plaque was recorded using a modified hygiene index, gingivitis was~     assessed using the simplified gingival index and dental caries was measured by recording the~     number of Decayed, Missing and Filled teeth (DMFT) using the British Association for the~     Study of Community Dentistry (BASCD) criteria. All children were examined by two calibrated~     dentists, using a World Health Organisation (WHO) periodontal probe and artificial light.~     Questionnaires were delivered and clinical examinations were performed at baseline and at 6~     and 18 months post-intervention. The EL oral health educational program was implemented by~     teachers using the program's manual.~   "
95269|NCT02320149|"~     To evaluate the efficacy and safety of an approximate 1.5mg/kg/day dose of oral sarecycline~     compared to placebo in the treatment of moderate to severe facial acne vulgaris~   "
95270|NCT02320136|"~     The investigators want to characterize high-frequency oscillations (HFOs) in intracranial~     recordings, which may occur as markers of epileptogenic tissue and also under physiological~     stimulation.~      The investigators want to show that recording of high-frequency oscillations (HFOs) is~     feasible in our project population both intraoperatively and during presurgical physiological~     conditions.~   "
95271|NCT02320123|"~     Racial differences in health care are documented across the health care continuum and persist~     in aging and end-of-life (EOL) care. African Americans (AA) and other underrepresented~     minorities often choose more aggressive therapies at the end of life and are less likely to~     utilize hospice care in the terminal stages of their illness. Potential reasons for these~     disparities include: lack of knowledge of and misperceptions about palliative and hospice~     care, spiritual beliefs, and mistrust in the health care system, among others. Despite the~     literature on disparities in end-of-life (EOL) care and reasons for underuse and the presence~     of national EOL care guidelines, attempts to address this problem have been limited and often~     not rigorously evaluated. The majority of interventions to promote EOL care were done in~     majority populations and focused predominantly on trying to change physician awareness of~     patient's pain, symptoms, and values or to change physician communication behavior. While~     these early studies made tremendous contributions to the study of EOL care and the needs of~     the terminally ill, the interventions associated with these studies did not reach their~     desired effectiveness. The investigators propose a different strategy that would focus~     specifically on previously identified barriers to utilization of advance directives,~     palliative care, and hospice care among African Americans - including physicians' difficulty~     and discomfort with prognostication, AA patients' knowledge, attitudes and beliefs towards~     hospice and palliative care, conflict between patients' spiritual beliefs and the general~     hospice and palliative medicine philosophy of care, and medical mistrust. The goal of this~     project is to improve methods of prognostication for physicians and increase awareness of EOL~     care options for AAs. To overcome the dual challenges of physicians' reluctance to discuss~     EOL care and patients' discomfort in engaging in such conversations, the investigators will~     use the electronic medical record (EMR) to automatically identify AA patients with~     life-limiting illness who are eligible for counseling about EOL care options. To change~     knowledge and attitudes toward EOL care options among AA patients, the investigators will~     design a culturally sensitive intervention that will combine multimedia materials and a~     culturally concordant lay health advisor who will deliver tailored education and counseling.~   "
95272|NCT02320110|"~     Childhood obesity is one of the most serious global public health challenges of the 21st~     century (Daniels et al., 2009). Mexico has the highest prevalence of obesity, (Secretaría de~     Salud, 2009); 34.4% of children and 35% of adolescents are overweight or obese (ENSANUT~     2012). Obesity has major health consequences for children and adolescents; On the other hand,~     undernutrition as well has important deleterious consequences on children's health.~      Anything that disrupts energy balance may cause individuals to be underweight, overweight or~     obese. Fat has been considered an endocrine organ for some time (Elizondo, 2011). Recently,~     skeletal muscle has been shown to function as a peripheral endocrine organ by releasing~     myokines, (Pedersen, 2012). Most recently, a new identified hormone secreted by muscle tissue~     in mouse, irisin, has been discovered. Irisin acts on white adipose cells in culture and in~     vivo to stimulate UCP1 expression and a broad program of brown-fat-like development. Irisin~     was induced with exercise in mice and humans which caused an increase in energy expenditure~     in mice with no changes in movement or food intake (Boström et al., 2012).~      Irisin was thus, promptly hypothesized as a hormone influencing body weight, obesity and type~     2 diabetes mellitus, among other conditions (Sanchis-Gomar et al., 2012). Some studies have~     indicated that circulating levels of irisin in humans correlate positively with~     anthropometric parameters such as BMI, fat mass, fat free mass, and are higher in obese~     patients compared to lean ones (Stengel et al., 2013; Huh et al., 2012; Roca-Rivada et al.,~     2013; Crujeiras et al., 2014; Pardo, 2014). Studies have shown an association between irisin~     levels, insulin resistance and the metabolic syndrome (Park et al., 2013; de la Iglesia et~     al., 2014; Crujeiras et al., 2014; Pardo et al., 2014). However, some others have found a~     negative correlation with anthropometric parameters, finding lower irisin levels in obese~     patients (Moreno-Navarrete et al., 2013). Noteworthy, all these studies have been performed~     in adults. To date, there are only two studies evaluating irisin levels in children. One~     found that a 1-year long lifestyle intervention program was associated with an elevation in~     irisin levels in obese children, although no correlation was found between irisin levels and~     anthropometric markers (Blüher et al., 2014). The other study investigated normal weight~     Saudi children and found correlations between circulating irisin and glucose and HDLc, but a~     negative association with insulin resistance (Al-Daghri et al, 2014).~      Besides, associations between irisin levels and adiponectin, leptin and resistin in the set~     of obesity have been explored, the three of them are implicated in the physiopatology of~     obesity.~      As there are still conflicting data regarding the association of irisin with anthropometric~     parameters, obesity and the metabolic syndrome, as well as its 'association with other~     adiponectines, and most important, there is scarce data of these associations in children,~     the objective of this study will be to correlate the circulating irisin and adipokines levels~     across a broad spectrum of body mass index ranging from undernourished to obese as well as~     with insulin resistance and risk factors for the metabolic syndrome in Hispanic children.~      The sample size with statistical power for this study yielded a sample of 40 children. Frozen~     stored plasma (-80°C) will be taken from a previous study performed in children which has~     been published (Elizondo-Montemayor et al., 2014). The samples will be divided into five~     groups, 8 per group, according to the CDC and American Academy of Pediatrics body mass index~     percentile classification: 1.) underweight = <3 percentile; 2.) normal weight = >3 - < 85~     percentile; 3.) Overweight = >85 - < 95 percentile, and 4.) obese = > 95 percentile. The~     fifth group will correspond to children with known metabolic syndrome according to the~     classification specified by Cooks et al (2008). Anthropometric measurements will include BMI,~     percentile BMI, waist circumference, % body fat, fat mass, fat free mass, and triceps skin~     fold. Biochemical measurements will include glucose, total cholesterol, low-density~     cholesterol (LDL), high-density cholesterol (HDL-c) and triglycerides. Clinical measurements~     will include blood pressure, physical activity records and dietary habits. All biochemical,~     anthropometric and clinical measurements were previously performed in a former published~     study (Elizondo-Montemayor et al., 2014).~      Irisin, adiponectin and leptin will be measured in plasma media using commercial ELISA kits.~   "
95273|NCT02320097|"~     When examining a subject in quiet stance from the side, the leg segment is usually seen to be~     oriented upwards and forwards by about 5°; the knee may be flexed by a few degrees, the~     shoulders are behind the great trochanter and the head is held forwards. The forward head~     position moves the center of gravity forwards and thus may increase pressure under the~     forefoot. Conversely, moving the head backwards should be accompanied by an increase in~     pressure under the heel and thus decreased pressure under the forefoot.~      The study's objective is to study the influence of alignment of the head with the back (i.e.~     a rearward head position) and head rotation on the foot pressure distribution (measured using~     a foot pressure platform).~   "
95274|NCT02320084|"~     The purpose of this study is to look at the long term safety profile of Orfadin treatment in~     patients suffering from hereditary tyrosinemia type 1 (HT-1). Patients included in the study~     will use Orfadin according to normal clinical practice.~   "
95275|NCT02320071|"~     The primary objective of the present study is to investigate a possible correlation between~     abdominal wall function and subjective measures of QoL before and after laparoscopic repair~     of small- to medium sized incisional hernia.~      This prospective study includes 25 patients undergoing laparoscopic incisional hernia repair.~     Abdominal wall function is examined by determination of maximal truncal flexion and extension~     with a fixated pelvis using a Goodstrength dynamometer (Metitur Ltd., Jyväskylä, Finland).~     Subjective scores of QoL (HerQLes), pain (visual analogue scale) and physical activity~     (International Physical Activity Questionnaire) are assessed. Patients are examined before,~     one month after and three months after the operation. Furthermore, pulmonary function is~     examined preoperative and three months postoperative by standard spirometry (forved vital~     capacity, peak expiratory flow, forced expiratory volume in 1 second) as well as maximum in-~     and expiratory pressure is measured.~   "
95276|NCT02320058|"~     This is a study of Nivolumab combined with Ipilimumab followed by Nivolumab by itself for the~     treatment of patients with Melanoma that has spread to the brain. Patients with~     histologically confirmed Malignant Melanoma and asymptomatic brain metastases are eligible~     for the study.~   "
95277|NCT02320045|"~     A Phase 1 study to evaluate the pharmacokinetics of ITCA 650 in subjects with mild and~     moderate renal impairment compared to the pharmacokinetics of subjects with normal renal~     function~   "
95279|NCT02320019|"~     Research Hypothesis:~      There will be a greater proportion of VAS responders defined as those who achieve ≥ 50%~     reduction from baseline in VAS for low back pain at week 12 following intradiscal injection~     of YH14618 compared to placebo. Patients have been diagnosed as one or two symptomatic lumbar~     degenerative disc disease defined as Pfirrmann grade 2 to 4 using MRI. Patients have suffered~     from persistent low back pain with at least 3 months of conservative therapy and must have~     low back pain measured by VAS≥4 cm and modified Oswestry disability index (mODI) ≥30% at the~     baseline.~   "
95280|NCT02320006|"~     Acupuncture is one of the traditional Chinese practices widely used in China for more than~     3000 years. In recent years, the use of acupuncture within infertility has gained popularity~     all over the world, but there is no research describing the use of acupuncture in infertility~     of incompletely obstructive fallopian tube. In this paper, we present a research design~     evaluating the effects of acupuncture on incomplete fallopian tube obstructive infertility.~     This is a randomized, control acupuncture and signal-blind trial. A total of 120 patients~     will be enrolled in this study and will be randomized into two groups. True acupuncture plus~     hydrotubation or control acupuncture plus hydrotubation will be performed for 12 weeks. The~     purpose of this paper is to evaluate the additional value of acupuncture on the tubal patency~     rate and pregnancy rate beyond Hydrotubation ,therefore to guide clinical.~   "
95281|NCT02319993|"~     keywords： Traditional Chinese Medicine, Herbs, Clinical trial, Insomnia, Quality of life,~     Suan-Zao-Ren Tang, Tian-wang-bu-xin-dan~   "
95282|NCT02319980|"~     The aim of this study is to investigate whether extracranial-intracranial(EC-IC) bypass~     surgery could prevent rebleeding and improve neurological function in adult moyamoya with~     hemorrhagic onset.~   "
95283|NCT02319967|"~     Chicago is an epicenter for asthma health disparities in the U.S., with African-American~     children 5-11 yrs bearing a disproportionate share of the burden. Among the most visible of~     these disparities is the high rate of visits to the Emergency Department (ED) for~     uncontrolled asthma. Clinical uncertainties regarding the real-world effectiveness of~     guideline recommendations for ED discharge and strategies to reduce environmental triggers at~     home contribute to practice variation and poor adherence to guidelines. The CHICAGO Trial~     tests both ED- and home-level interventions to improve clinically meaningful outcomes in a~     minority pediatric ED population with uncontrolled asthma.~   "
95284|NCT02319954|"~     Periorbital edema and ecchymosis are common morbidities in the post-operative period after~     rhinoplasty. Lateral osteotomy techniques used to reshape the bony nasal pyramid are large~     contributing factors to the degree of bruising and edema. This is due to injury to the~     angular vessels that are crossing the osteotomy sites. Depending on the degree of swelling~     and bruising, it can cause difficulty with visual acuity in the early post-operative period.~     Most importantly, this can be quite distressing to the patient and impact the time required~     to return to normal social activities. Numerous studies have examined various interventions~     to reduce periorbital swelling and ecchymosis. These include peri-operative steroids,~     lidocaine with epinephrine injections, fibrin sealant, permissive intra-operative hypotension~     and subperiosteal osteotomy techniques. Peri-operative steroids have been most extensively~     studied. Recent meta-analysis by Hatef et al, found that pre-operative steroids were~     effective for decreasing post-operative edema and ecchymosis. Steroids however, carry with it~     the risks of psychosis, immunosuppression, weight gain, uncontrolled blood glucose and~     avascular necrosis of the hip. As such, broadly applicable and cost-effective techniques to~     minimize post-operative edema and ecchymosis without the risk profile of steroids would be~     ideal. Taskin et al. recently examined the efficacy of the combination of intraoperative cold~     saline-soaked gauze compression and corticosteroids on rhinoplasty morbidity. The study group~     received compression with a cold saline soaked gauze to the nasal dorsum during the surgery~     and the control group received compression with a dry gauze. Both groups received a~     pre-operative dose of intravenous steroids. The study group had significantly less~     periorbital edema and ecchymosis on post-operative days 1, 3, 5 and 7. This study~     unfortunately did not examine the role of compression alone and the study was performed in~     the presence of steroids, which is not routinely utilized by all surgeons. As such, the~     proposed study will provide evidence for the use of direct compression intra-operatively~     after lateral osteotomy in order to reduce post-operative edema and ecchymosis. The findings~     of this study may provide a simple, effective and non-costly technique to minimize the~     morbidity of rhinoplasty.~   "
95285|NCT02319941|"~     The purpose of this study is to compare Low-Dose, Standard-Dose Ticagrelor and Clopidogrel~     for Inhibition of Platelet Reactivity in Patients with Acute Coronary Syndromes~   "
95286|NCT02319928|"~     This protocol describes the epos (ancient greek (Επος) for story) of a group of related~     clinical trials aiming at addressing one of the most important unsolved challenges in the~     prevention of colorectal cancer (one of our major cancer killers); the surveillance of~     patients with premalignant polyps in the large bowel.~      This project is timely because large scale colorectal cancer screening programmes are~     currently rolled out in most Western countries. These programmes are diagnosing large numbers~     of individuals with premalignant polyps (adenomas and serrated polyps). This creates both a~     diagnostic and resource dilemma, because the optimal surveillance strategy for these~     individuals to reduce future cancer risk is currently unknown..~      The EPoS trials will randomize or register more than 27,500 individuals in different European~     countries to different surveillance colonoscopy intervals to disentangle the most effective~     and cost-effective surveillance strategy for the population. Subjects will be randomized~     according to their presenting polyp chracteristics The EPoS I trial randomizes patients with~     low-risk adenomas into 5 or 10-year surveillance; ; EPoS II randomizes patients with~     high-risk adenomas into 3 or 5-yearly surveillance ; EPoS III will include patients with~     serrated polyps in a one-arm study with surveillance after 5 and 10 years. The primary~     endpoint for all three trials is incidence of colorectal cancer after 10 years of follow-up.~      This EPoS trials are the largest in polyp surveillance ever conducted. They address a~     clinical problem affecting hundreds of thousand individuals in Europe and the US each year,~     it has a large size, and should thus provide definitive results.~   "
95287|NCT02319915|"~     Evaluate the pharmacokinetic profile of tranexamic acid injected intra-articularly with or~     without adrenaline, in a population of patients undergoing knee replacement.~   "
95288|NCT02319902|"~     To establish if heated humidified carbon dioxide gas improves pain scores as well as nausea~     and analgesic requirements in post operative patients compared to standard cold carbon~     dioxide.~   "
95304|NCT02319694|"~     This project studies the impulsive side effects of common treatments for Parkinson's Disease.~     By learning how parts of the brain involved in Parkinson's encode information related to~     reward and motivation, the investigators will better understand the reasons why Parkinson's~     patients often suffer from compulsive gambling, hypersexuality, and repetitive tinkering~     (punding). These results may lead to the design of better methods of deep brain stimulation~     (DBS) that minimize the behavioral side effects of Parkinson's treatment.~   "
95474|NCT02317458|"~     This study is designed to evaluate the efficacy and safety of the C3BS-CQR-1 in the treatment~     of patients with chronic heart failure secondary to ischemic cardiomyopathy.~   "
95289|NCT02319889|"~     This pilot clinical trial studies stereotactic body radiation therapy followed by combination~     chemotherapy in treating patients with non-small cell lung cancer. Stereotactic body~     radiation therapy is a specialized radiation therapy that delivers one to five high doses of~     radiation directly to the tumor and may kill more tumor cells and cause less damage to normal~     tissue than conventional radiation. Drugs used in chemotherapy, such as carboplatin and~     paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the~     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Giving stereotactic body radiation therapy, followed by~     carboplatin, and paclitaxel albumin-stabilized nanoparticle formulation may kill more tumor~     cells and result in a better and more durable response than conventional radiation and~     chemotherapy. The purpose of this study is to test the safety of this approach prior to~     larger studies.~   "
95290|NCT02319876|"~     The current project was designed to examine the express TIM-3 on lymphocytes and monocytes~     and its role in immunosuppression during sepsis.~   "
95291|NCT02319863|"~     This study examines the role of this simple technique on postoperative metastasis and long~     term survival.~   "
95292|NCT02319850|"~     Sarcopenia is an age-related loss of muscle mass that may affect over 25% of individuals over~     the age of 60 and results in a 3 to 4 times increased likelihood of developing a disability.~     Despite these observations, sarcopenia is rarely subject to a systematic screening process as~     a part of customary geriatric care. Furthermore, when lean body mass (LBM) is measured via~     dual energy X-ray absorptiometry (DXA) in older adults, it is typically within a reactive,~     hospital-based, model of healthcare where muscle wasting is only assessed after a loss of~     functional independence. The investigators propose an affordable, portable screening method~     with ultrasound imaging to be performed in primary care settings.~      The investigators long term goal is to identify individuals at risk, and intervene with~     treatments that may prevent the onset of debilitating loss of muscle function in the elderly.~   "
95293|NCT02319837|"~     The purpose of this study is to assess enzalutamide plus leuprolide in patients with~     high-risk nonmetastatic prostate cancer progressing after radical prostatectomy or~     radiotherapy or both.~   "
95294|NCT02319824|"~     This pilot, phase I trial studies the safety of cancer-testis antigen (NY-ESO-1)-specific T~     cells (a type of immune cell) in treating patients with NY-ESO-1-expressing sarcomas that~     have spread to other places in the body and are receiving palliative (relief of symptoms and~     suffering caused by cancer) radiation therapy. Placing a modified gene for NY-ESO-1 into~     white blood cells may help the body build an immune response to kill tumor cells that express~     NY-ESO-1. Palliative radiation therapy may help patients with advanced sarcoma live more~     comfortably. Giving NY-ESO-1-specific T cells following palliative radiation therapy may be a~     better treatment for patients with sarcomas.~   "
95295|NCT02319811|"~     The purpose of this study is to determine the long-term survivorship and clinical outcomes of~     all cryopreserved meniscus transplants performed by Dr. Frank Noyes.~   "
95296|NCT02319798|"~     Inflammatory bowel disease (IBD) refers to two chronic diseases (Crohn's disease and~     ulcerative colitis) that affect the intestines. The number of new cases of IBD in people~     younger than 16 years old has been increasing in the United Kingdom (UK), and is currently~     estimated to be 700 new cases every year. There is no cure for IBD and patients experience~     episodes of flareups in between periods of wellbeing.~      Traditionally, children with IBD are asked to attend regular hospital appointments. This~     means that, even if they are well, they have to get to the hospital and this can involve~     travelling long distances.~      Telephone consultations have been shown to be beneficial in some areas of medicine but this~     approach has not been well studied in children. The aims of this study are to determine~     whether telephone consultations would improve quality of life, patient satisfaction,~     proportion of consultations attended and whether they would be safe and reduce costs for~     patients and the National Health Service (NHS). Investigators plan a randomised controlled~     trial involving 92 participants recruited from amongst the 250 children and adolescents aged~     between 8 and 16 years who attend the regional paediatric IBD centre in Manchester. Half will~     be assigned to telephone consultations, and half to face to face consultations. The study~     would have the approval of the local ethics committee and participants would have provided~     written consent. Investigators will compare outcomes in the two groups over 2 years. If~     telephone consultations prove to be effective, the NHS could offer children with IBD the~     choice of either telephone consultation or face to face consultation for their outpatient~     followup. Those who are doing well would not have to make unnecessary journeys to the~     hospital. This would free up clinic spaces and allow patients who are unwell, and new~     patients to be seen more quickly, thus reducing waiting~   "
95297|NCT02319785|"~     The main purpose of this study is to examine the treatment effects and the combined-therapy~     of the robot-assisted therapy (RAT) by using two groups of combined-therapy with different~     sensory feedback and one group of unilateral RAT in the investigators trial to compare the~     relative treatment effects to mirror therapy group, bilateral RAT, and conventional~     rehabilitation (CR) considering motor ability, basic daily functions, mobility, quality of~     life, and kinematic variables.~   "
95298|NCT02319772|"~     This is a 2-part, first-in-human dose-ranging study to evaluate the safety, tolerability and~     pharmacokinetics of escalating doses of BCX4430 administered via intramuscular (IM) injection~     in healthy subjects. In part 1, subjects will receive a single dose of BCX4430; in part 2~     subjects will receive BCX4430 for 7 days.~   "
95299|NCT02319759|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of guselkumab~     in participants with Active Psoriatic Arthritis (PsA).~   "
95300|NCT02319746|"~     General objective:~      To assess the effectiveness of a treatment program specific for cannabis abuse (cognitive~     behavioral treatment + pharmacological treatment) compared to standard treatment~     (pharmacological treatment + psychoeducation) in patients with first episodes psychosis (FEP)~     cannabis users.~      Design A multicenter single-blind randomized study with 1 year of follow-up. The~     effectiveness of a treatment program specific for cannabis abuse (cognitive behavioral~     treatment + pharmacological treatment) compared to standard treatment (pharmacological~     treatment + psychoeducation) in patients with first episodes psychosis (FEP) cannabis users~     will be assessed.~      Patients will be randomly assigned to one of two treatments:~        1. Experimental group (N=50): Cognitive-behavioral treatment specific for cannabis abuse +~          pharmacological treatment~        2. Control group (N=50): standard treatment: psychoeducation + pharmacological treatment~   "
95301|NCT02319733|"~     The aim of the study is to assess if implantation of a bioresorbable vascular scaffold (BVS)~     for intermediate coronary lesions with morphological signs of vulnerable plaque in patients~     prone for acute coronary syndromes (ACS) will stabilize the plaque, improve natural~     vasomotion and increase vascular diameter.~   "
95305|NCT02319681|"~     This study seeks to establish the acceptability and evaluate the limited efficacy of Simple~     Reminiscence (SR), a home-delivered non-pharmacological intervention designed to relieve~     stress, improve affect, and prevent or quell disruptive or maladaptive behaviors in~     community-residing individuals diagnosed with early Alzheimer's disease (EAD). Unmanaged~     episodes of anxiety can be antecedents of maladaptive behaviors, including agitation, anger,~     and sometimes even violence.~      SR is a dyadic strategy; both the person with EAD and the caregiver engaged the patient's~     memory to interrupt a current episode of anxiety.~   "
95306|NCT02319668|"~     The primary objective of this study will be to evaluate the effect of two week pre-surgical~     rinsing with an antimicrobial mouthrinse containing 0.2% w/v Chlorhexidine digluconate on the~     total number of plaque bacteria in the mouth 3 days post implant surgery. The study will be~     conducted at Eastman Clinical Investigation Centre (ECIC), University College London (UCL)~     Eastman Dental Institute. Participants will be those who require a single and simple surgical~     implant to be placed, and will be recruited from new patient referrals within the Eastman~     Dental Hospital~   "
95307|NCT02319655|"~     During the last decade optical coherence tomography (OCT) extended the possibilities for in~     vivo macula diagnostic and was increasingly used for pre- and post-operative imaging of~     retinal diseases. Spectral-domain optical coherence tomography (SD-OCT) with its increased~     scanning speed and image-resolution provides more detailed information of microstructures in~     the macula. Epiretinal membrane (ERM) is a disorder involving the posterior pole of the~     eyeball. It can be idiopathic or caused secondarily in various ocular conditions, such as~     uveitis, trauma, retinal detachment or retinal vascular diseases. In patients who suffer from~     loss of vision and metamorphopsia, vitrectomy and membrane peeling is usually performed to~     remove the ERM.~      Different study groups showed that intraoperative use of SD-OCT is possible. Two groups~     already achieved to work operation microscope integrated SD-OCT setup. Due to the high axial~     resolution of the SD-OCT some groups reported about an increased hyporeflective zone in the~     subfoveal region appearing directly after the membrane peeling procedure. It was hypothesized~     that this phenomenon could be an expression of surgical trauma, as this hyporeflective zone~     disappears in follow up OCT 10 days after surgery.~   "
95308|NCT02319642|"~     This study will continue to evaluate the safety & efficacy of Certolizumab Pegol (CZP) for 6~     months in Chinese subjects with active Rheumatoid Arthritis who participated in RA0044.~   "
95309|NCT02319629|"~     Risk factor of cholelithiasis is rapid weight loss after bariatric surgery and change in the~     gallbladder function which is secondary to surgery. Many observational studies support this~     fact, and a high incidence of 28% -71% after gastric bypass surgery (RYGB) was reported in~     them. According to another publication, the incidence of gallbladder diseases is 5-36% after~     jejunoileal bypass surgery and 2.8-36% after gastric bypass surgery.~   "
95310|NCT02319616|"~     The primary objectives of this study are to investigate the efficacy and safety of topical~     steroid ointment (clobetasol 0.05%) for the treatment of the cutaneous manifestations of~     toxic epidermal necrolysis (TEN).~   "
95311|NCT02319603|"~     A randomized, double-blind, two dose group, parallel-control multi-center, post-marketing~     clinical trial，to evaluate the efficacy and safety of Wenxin keli in treating atrial~     premature beats by different dose,to provide a scientific basis for rational clinical use of~     drug.~   "
95312|NCT02319590|"~     The study aims 1) to determine autoantibody titers against the AGTR1 receptor and against the~     ETA receptor, 2) to characterize cytokine expression profiles of heart-specific activated T~     cells in patients with systolic heart failure. Auto-antibody titers and specific cytokine~     expression profiles in heart-specific activated T cells will then be correlated with heart~     failure progression and outcome.~   "
95313|NCT02319577|"~     A sub-population of patients affected by non-small cell lung cancer (NSCLC) with activating~     mutations of the epidermal growth factor receptor (EGFR) do not gain benefit from treatment~     with tyrosine-kinase inhibitors (TKIs). The hypothesis of this study is that the addition of~     chemotherapy with oral vinorelbine to first-line TKI might result in improved outcomes in~     EGFR-mutated patients.~   "
95314|NCT02319564|"~     The investigators goal is to conduct a pilot randomized controlled trial (RCT) whose purpose~     is to determine the feasibility of a randomized trial designed to determine if either inhaled~     beclomethasone or a combination of inhaled beclomethasone/salbutamol (Clenil Compositum) are~     superior to placebo in treating pre-school aged children with an acute wheezing episode.~   "
95315|NCT02319538|"~     The investigators have already proven that absolute total thyroidectomy gives elimination of~     anti-TPO antibodies. Our hypothesis is that this elimination also eliminates the typical~     Hashimoto symptoms, namely: Serious tiredness, increased need of sleep, pain in musculature~     and joints and dryness in eyes and mouth. The prerequisite for this effect is that the total~     thyroidectomy is meticulously performed. There exists no other treatment that can eliminate~     the antibodies. The study is randomized between operation and ordinary conservative medical~     treatment with thyroxine control and supplementation. The symptoms in both groups are~     evaluated by 5 different Quality of Life schemes, internationally approved.~   "
95316|NCT02319525|"~     The study will compare the efficacy of the usual education materials to individualized~     computerized decision guide on decision conflict of patients with lupus nephritis making~     treatment decisions regarding immunosuppressive therapies.~   "
95317|NCT02319512|"~     The purpose of this study is to determine whether the use of chewing gum effects~     postoperative ileus after pancreaticoduodenectomy.~   "
95341|NCT02319200|"~     Metformin treatment during 36 months could be associated with decreased risk of HCC~     occurrence and liver related death in patients with compensated HCV cirrhosis and~     insulinoresistance.~      This study is an ancillary of the observational study from the CIRVIR cohort in which more~     than 1200 patients with compensated HCV cirrhosis are currently included.~      participating centers : 26~   "
95342|NCT02319187|"~     Esophageal cancer is a highly aggressive malignancy with a poor overall outcome.~      The purpose of this study is to evaluate the progression free survival and safety of~     irinotecan plus S1 versus S1 alone in the patients with previously treated advanced~     esophageal cancer~   "
96584|NCT02302963|"~     This is a randomized, controlled trial of Unified Safety System (USS) Virginia closed-loop~     versus sensor-augmented pump (SAP) therapy for hypoglycemia prevention in subjects with type~     1 diabetes and hypoglycemia unawareness and/or risk for hypoglycemia.~   "
95318|NCT02319499|"~     Many Indonesian infants are already iron deficient before they reach the age of six months,~     which also determines the high prevalence of anemia among under-five children. Iron~     deficiency ultimately leads to anemia, and there is clear evidence that iron deficiency~     anemia during early childhood has a marked negative effect on child development and cognitive~     function (Lozoff et al.1991; Idjradinata & Pollitt, 1993). This negative impact on childhood~     development is one of the main reasons why iron deficiency during infancy should be prevented~     or treated.~      Since diets low in iron is usually also low in zinc, zinc deficiency --which has negative~     consequence on growth-- is common in iron deficiency area. In Southeast Asia, the condition~     is exacerbated by the rich phytate content in the complementary foods which inhibits the~     absorption of iron as well as zinc (Gibson, 1994). Thus, combining both iron and zinc, hence,~     is expected to decrease both iron and zinc deficiencies and hence improve growth and~     development of the children.~      Recently, there has been an emerging view which looks at the two-way relationship between~     nutrition, health, and psychosocial well-being. This concept is supported by studies on~     positive deviance, a term used to refer to children who grow and develop well in~     impoverished environments where most children are victims of malnutrition and chronic illness~     (Zeitlin et al., 1990). The mechanism which helps to explain how psychosocial factors, such~     as the affect between mother and child, are associated with adequate growth and development:~     'Psychological stress has a negative effect on the use of nutrients whereas psychological~     well-being stimulates the secretion of growth-promoting hormones. Pleasantly stimulating~     interactions can enhance the child's tendency to exercise its developing organ systems and~     hence to utilize nutrients for growth and development'.~      Understanding how the psychosocial environment can promote or inhibit the benefit of~     supplementation intervention is necessary in order to have a better way of setting about~     providing supplements. In fact, many supplementation programs do not incorporate~     complementary program elements that would help to improve the health and psychosocial~     development of children at the same time that they improve nutritional status' (Myers, 1995).~     Looking from this perspective, not only will supplementation benefit the psychosocial~     development but also the psychosocial environment can promote the benefit of the~     supplementation on the nutritional status and developmental outcomes of infants.~      The purpose of the study is to investigate whether multi-micronutrient supplementations~     (zinc+iron, zinc+iron+vit.A) have positive effect on infants' growth and developmental~     outcomes, and whether the effect is modified by psychosocial care.~   "
95319|NCT02319486|"~     This study will evaluate a uniform chemotherapy protocol for nonmetastatic extraocular~     retinoblastoma~   "
95320|NCT02319473|"~     Jakarta acute coronary syndrome enrolled patients with acute coronary syndrome admitted to~     the emergency department of all health centers in Jakarta and the surrounding area.~   "
95321|NCT02319460|"~     This observational cohort study is designed to obtain product safety information from the~     routine clinical setting within large, diverse, community-based populations. In the setting~     of acute major bleeding in which patients are treated for Vitamin K antagonist reversal, the~     risk of thromboembolic events (TEE) in patients treated with Kcentra® and in patients treated~     with plasma will be assessed.~   "
95322|NCT02319447|"~     For most patients with kidney failure, living donor kidney transplant (LDKT) is their best~     treatment option. Unfortunately, Blacks (vs. non-Blacks) are more likely to have kidney~     failure but less likely to receive LDKTs. In this study, the investigators will test an~     intervention designed to address this disparity, by performing a parallel group, two-arm~     randomized clinical trial among 500 Black kidney transplant candidates. The main objective of~     this study is to test an educational and behavioral intervention that is designed to increase~     receipt of LDKT among transplant candidates (persons active on the deceased donor kidney~     transplant waiting list) who are Black. Our overall hypothesis is that a multi-component~     intervention administered to Black transplant candidates will increase both readiness to~     pursue LDKT and actual receipt of LDKTs. The investigators will randomly assign kidney~     transplant candidates on the kidney transplant waiting list to either: (1) a control group~     that will receive Usual Care, or (2) an Intervention group that will receive a group-based~     intervention, as well as monthly mailings and a follow-up phone call by a transplant~     educator.~   "
95323|NCT02319434|"~     The purpose of this study is to determine the usability and acceptance of the Ostom-i Alert~     Sensor. The investigators would like to see if is generally helpful to ostomy patients and~     whether it has a beneficial impact on living with an ostomy bag. Results from this study will~     be used to determine if a larger clinical study is feasible.~   "
95324|NCT02319421|"~     Context: Alarm fatigue is a threat to hospital patient safety. National surveys reveal that~     high alarm rates interrupt patient care, reduce trust in alarms, and lead clinicians to~     disable alarms entirely. Safety huddles offer an appropriate forum for reviewing alarm data~     and identifying patients whose high alarm rates may necessitate safe tailoring of alarm~     limits.~      Objectives: To evaluate the impact of a focused physiologic monitor alarm reduction~     intervention integrated into safety huddles that involves discussing safe monitor parameter~     adjustments on the physiologic monitor alarm rates of individual patients with high alarm~     rates who meet low acuity criteria.~      Study Design: A prospective, quasi-experimental pilot study of the impact of the huddle~     intervention on the alarm rates of low acuity high alarm rate individual patients discussed~     in huddles in the PICU. The huddle intervention will consist of a script to facilitate the~     discussion of the alarm data.~      Setting/Participants: Participants will include all low acuity patients and their providers~     in the PICU at The Children's Hospital of Philadelphia.~      Study Interventions and Measures: The primary outcome is the rate of crisis and warning~     alarms per patient day for intervention cases as compared with others in the high alarm / low~     acuity cohort. Safety measures will include unexpected changes in patient acuity or code blue~     events within one week of monitor change or discharge.~   "
95325|NCT02319408|"~     Insufficient migration and activation of tumour specific effector T cells seems to be the one~     important reason for inadequate host anti-tumour immune response. Ionizing radiation can~     induce a variety of immune responses. The goal of this randomized trial is to assess if a~     preoperative single fraction low dose radiation is able to improve anti-tumour immune~     response in operable early stage lung cancer.~   "
95326|NCT02319395|"~     The  Behavioural Addiction and Genetics in Parkinson's Disease  study (BADGE-PD) is a~     national (France), multicenter, genetic association, case-control study to identify genetic~     factors associated with behavioural addiction (or Impulse Control Disorders, ICD) related to~     dopamine agonists treatment in Parkinson's disease (PD). Polymorphisms of candidate genes~     supposed to be involved in this adverse effect will be compared in 200 PD patients with ICD~     (n=200) and 200 matched PD patients without ICD (n=200).~   "
95358|NCT02318979|"~     The proposed study aims to characterize the effects of running-specific leg prosthetic~     stiffness and height during on performance during running and sprinting to optimize~     running-specific prosthesis prescription. The investigators will collect biomechanical and~     metabolic data from participants with unilateral and bilateral below the knee amputations~     while they run at different speeds on a treadmill. This data will be used to understand the~     effects of running prostheses. Then, these parameters will be used to develop prosthetic~     prescription techniques for people with below the knee amputations.~   "
95359|NCT02318966|"~     To compare efficacy of Glycosade® with uncooked corn starch (UCCS for the dietary management~     of hepatic glycogen storage diseases (GSD).~   "
95327|NCT02319382|"~     There is accumulating evidence suggesting that inflammatory processes, through microglial~     activation, would play a key role in the neurodegenerative process of Parkinson's disease~     (PD). It is considered that microglial activation would be part of self-propelling cycle of~     neuroinflammation that fuels the progressive dopaminergic neurodegeneration. It is however~     hard to evidence microglial activation in vivo, especially in the substantia nigra: first,~     the investigators need very high resolution imaging tools and then, the only ligand available~     to date, 11C-PK11195, has a low sensitivity and specificity and provided heterogeneous~     results.~      18F-DPA-714 is a new PET ligand which labels microglial cells. The investigators aim to~     explore the topography and intensity of microglial activation in several different groups of~     PD patients: 1) de novo, drug-naïve subjects (n = 6); 2) non-fluctuating treated patients~     (honeymoon) (n = 10); 3) advanced drug-responsive patients motor fluctuations (wearing-off~     or dyskinesia) (n = 6); 4) patients with LRRK2 gene mutation (n = 6); and 5) related to~     healthy patients carriers of the mutation LRRK2(n = 6). PET imaging will be performed with a~     new generation tomography having a very high resolution.~      This study might reveal significant neuroinflammatory process in the midbrain of PD patients~     and will determine if such process is present in both sporadic and genetic forms of PD. The~     results of this study might provide a new biomarker of disease pathological progression and~     help as identifying subjects who might most benefit from a specific anti-inflammatory drug.~   "
95328|NCT02319369|"~     This will be a Phase 1, open-label study of DS-3032b to assess its safety and tolerability~     and identify a Maximum Tolerated Dose (MTD)/tentative Recommended Phase II Dose (RP2D) in~     subjects with refractory or relapsed Acute Myelogenous Leukemia (AML), Acute Lymphocytic~     Leukemia (ALL), Chronic Myelogenous Leukemia (CML) in blast phase, or high risk MDS in Part~     1-Dose Escalation and refractory or relapsed AML or high risk Myelodysplastic Syndrome (MDS)~     in Part 2-Dose Expansion.~   "
95329|NCT02319356|"~     The purpose of this study is to determine whether dietary nitrate supplementation improves~     performance in cardiopulmonary exercise testing (CPET).~   "
95330|NCT02319343|"~     This study evaluates the pathophysiological effects of a single dose Methylprednisolone~     administered prior to total knee-arthroplasty (TKA). The investigators examine the effect on~     thigh muscle function to evaluate the efficacy of Methylprednisolone on knee-extension~     strength at discharge after TKA.~      Half of participants will receive intravenous Solu-Medrol 125 mg, while the other half will~     receive placebo.~      The investigators hypothesize that the group receiving Methylprednisolone will experience~     smaller loss of knee-extension strength compared to the placebo-group, early after TKA.~   "
95331|NCT02319330|"~     The overall objective of this project is to demonstrate that a low cost, cell phone-delivered~     intervention is a promising, feasible and acceptable way to improve the prevention and~     treatment outcomes of women in India who are affected by HIV and inter-related mental health~     and psychosocial risk factors.~   "
95332|NCT02319317|"~     The specific aim of this study is to assess the feasibility of a web-based intervention to~     prevent risky driving with teen drivers licensed in the previous 90 days.~   "
95333|NCT02319304|"~     The purpose of this study is to assess the effects, both good and bad, of adding very low~     dose fractionated radiation therapy (LDFRT) to the pelvis, with FOLFOX chemotherapy prior to~     surgery. Standard pelvic radiation therapy given once a day (Monday through Friday) over~     approximately 5.5 weeks is not given in this study. You will receive 6 cycles of FOLFOX (each~     cycle is 2 weeks) and you will also get an LDFRT to your pelvis given twice a day on the~     first two days of each cycle.~   "
95334|NCT02319291|"~     This registry is intended to evaluate the clinical outcomes of the DePuy P.F.C. Sigma PS150~     RP Total Knee System. 200 participants will be enrolled prospectively or retrospectively and~     the follow up period will be 5 years. Data collection will include Radiographic Analysis,~     Knee Society Evaluation and Adverse Events.~   "
95335|NCT02319278|"~     To non-invasively image myocardial accumulation of ultrasmall superparamagnetic particles of~     iron oxide (USPIOs) by an increase in R2* values (compared to controls) within the myocardium~     of patients with:~      i. cardiac transplantation ii. acute myocarditis iii. suspected cardiac sarcoidosis~   "
95336|NCT02319265|"~     DAMSEL 2 is a pilot Phase II study in patients with sepsis. Stage 1 will assess the~     pharmacokinetics of melatonin and its major metabolite after a single dose of 50 or 100mg~     exogenous melatonin in two small groups of patients with sepsis in order to make dosing and~     dosing interval decisions for Stage 2.~      Stage 2 is a double blind randomised controlled trial of melatonin in patients with sepsis at~     the dose and dosing interval decided after Stage 1. Measurements of melatonin and its major~     metabolite, and an array of biomarkers of inflammation and oxidative stress will be made,~     plus transcriptome (mRNA) analysis. This study will inform a planned larger phase II trial.~   "
95337|NCT02319252|"~     The study is an unblinded randomized trial, designed to examine whether gastric- or jejunal~     feeding tubes are the most effect full to feed patients with alcoholic liver diseases and~     non-sufficient oral intake.~      The primary outcome will be differences in nutrition intake between the groups. Secondary~     outcomes will be: the amount of unplanned tube discontinuations; handgrip and patients'~     quality of life, nausea & vomiting.~      The study will include 40 patients at Aarhus University Hospital, Denmark.~   "
95338|NCT02319239|"~     Primary purpose of the study is to develop a stereotactic radiation treatment to prostate~     cancer which minimizes treatment related toxicity. Movement of the prostate during a~     radiation therapy will be monitored by temporary implanted electromagnetic transmitter. This~     data will be used to define prostate marginals (PTV) for stereotactic treatment. Radiation~     toxicity to rectum will be reduced by using a rectum fixation during a treatment.~      Study group I (20 patients) will be treated 39 x 2 Gy and study group II (20 patients) with~     20 x 3 Gy fractionation schedules. With the data collected from these groups treatment~     marginals to prostate will be defined and used to treat group III (40 patients) with 5 x 7.25~     Gy.~      Second purpose of this study is to assess if Diffusion-weighted magnetic resonance imaging~     could be used to evaluate radiation treatment response in intermediate prostate cancer.~     Androgen deprivation therapy is not allowed in this study.~   "
95339|NCT02319226|"~     Graft-versus-Host Disease (GVHD), is the most frequent and severe complication of allogeneic~     hematopoietic stem cell transplantation (HSCT). Much of our knowledge on the pathophysiology~     of GVHD has been gained from experimental models but far less from the study of the disease~     in humans. Recent developments in basic biology open new avenues to the development of~     biomarker sets that could predict GVHD severity and prognosis that could be tested and~     validated through well-designed multicenter clinical trials.~      The main goal of this project is to further our understanding of the pathogenic mechanisms of~     human GVHD on one hand, and of functional immune tolerance on the other. Furthermore, this~     study aims at setting up a clinically relevant biomarker set in human GVHD and immune~     tolerance in a discovery cohort.~      The objectives of this project are:~      1. To define phenotypic, functional and molecular correlates of acute GVHD early after~     HSCT/at its onset 2. To study thymic reconstitution and the T-cell repertoire after HSCT~     during period 2 3. To identify functional and molecular correlates of immune tolerance in~     long-term survivors of HSCT 4. Preparing for biomarker validation into a clinical trial We~     propose a prospective analysis of a cohort of 680 patients transplanted from an HLA-identical~     sibling donor at Saint Louis hospital. Analyses will be performed during 3 critical,~     clinically relevant, periods.~        1. Period 1: Analysis at the onset of GVHD, or at the time of engraftment 30 days after~          HSCT in patients not developing GVHD. An additional blood sample will also be analyzed~          90 days after HSCT.~        2. Period 2: Thymic function analysis using measurements of T-cell receptor excision~          circles (TREC) will be performed at 6 and 12 months post-transplant for all patients.~          T-cell receptor analysis on sorted T-cell populations will be performed by NGS.~        3. Period 3: In tolerant patients (patients more than 2 years after HSCT not requiring~          immunosuppressive treatment), or in patients still requiring immunosuppressive therapy~          after 2 years. We will also analyze the corresponding immune parameters for each donor.~      The longitudinal design of this study will allow us to provide an integrated view of GVHD~     pathophysiology and mechanisms of immune tolerance in human.~      Prospectively identified phenotypic, molecular or functional biomarkers will then be tested,~     in a subsequent study, from biological materials prospectively collected within the French~     wide CryoStem cohort. Thus, as the final task of this project, we will perform statistical~     analyses taking into account confounding clinical variables influencing the outcome (i.e.~     GVHD-related death or tolerance). Preparing for a clinical trial will need moving from~     classical Bioinformatics analyses into clinically relevant statistical analyses that include~     sequential biological measurement in the discovery set cohort. Main points that will be taken~     into accounts for this task are the followings;~        1. Transplant-related mortality (TRM) can be estimated in the range of 20%; 2year~          post-allogeneic HSCT~        2. TRM is mostly (even if totally) due to GVHD and its associated immune deficiency~        3. GVHD cumulative incidence can be estimated in the range of 40%~        4. 80 patients will be prospectively studied and 30 patients will be analyzed (cross~          sectional study) for part 3 only.~        5. Since GVHD-related mortality and tolerance are mutually exclusive situation the optimal~          calculation for the validation cohort can be expected~        6. This calculation will be the basis for the proposal of an interventional clinical trial.~   "
95340|NCT02319213|"~     The purpose of this study is to evaluate the changes of intraocular pressure due to the~     increase of intra abdominal pressure.~   "
95343|NCT02319174|"~     The purpose of the study is to help make a lower cost automatic blood pressure monitor device~     for diagnosis and monitoring of pre-eclampsia in pregnant women, where automatic blood~     pressure monitoring is limited or not available. The study will compare this low cost device~     to a commercially available system used for pre-eclamptic women in many United States~     hospitals that the investigators will be bringing to Malawi as a part of this study.~      The team hopes to show that this lower cost blood pressure machine works well and can help~     women with pre-eclampsia. The study also aims to see if this machine is easy for the nurse to~     use.~      70 pregnant women who are either at-risk or diagnosed with pre-eclampsia will be enrolled at~     University of Texas Health Science Center Houston. Patient arm circumference will be measured~     with measurement tape.~      They will be seated upright in a comfortable chair with arm at heart level and an arm blood~     pressure cuff from either the automatic blood pressure monitor or a manual sphygmomanometer~     will be placed on the left arm.~      The cuff will be inflated and then deflated until measurement concludes. Heart rate will be~     measured with tactile arterial palpation.The process will be repeated for a total of up to~     nine measurements, alternating between measurements with the automatic blood pressure monitor~     and the manual sphygmomanometer. There will be a waiting period of 45-60 seconds between each~     measurement.~      The results of this study will help researchers understand the performance and usability of~     this device in Malawi and help decide if any design changes are needed.~   "
95344|NCT02319161|"~     The investigators aimed to investigate the efficacy of calcium channel blockers and beta~     blockers for controlling tourniquet induced blood pressure increase in patients undergoing~     carpal tunnel operations with IVRA. For this purpose files of patients undergoing operation~     under IVRA were retrospectively examined in terms of demographical and hemodynamic variables.~   "
95345|NCT02319148|"~     The primary objective of the study is to estimate the effects of different strong enzyme~     (CYP3A4) inhibitors, itraconazole, diltiazem, or verapamil on the single dose~     pharmacokinetics of PF-00489791 in healthy volunteers. The study will enroll approximately 18~     subjects that are randomized to 1 of 3 treatment groups. The study is also intended to~     determine the safety and tolerability of single-dose PF- 00489791 when it is administered~     with steady-state itraconazole, diltiazem, or verapamil.~   "
95346|NCT02319135|"~     The hypothesis is that the replacement of the standard fludarabine and cytarabine based~     therapy by azacytidine could result in an improvement of RFS and OS rates in the experimental~     arm. To fulfill the medical needs in such frail and elderly population, improvements in terms~     of atileukemic efficacy in the azacytidine experimental arm should be attained without~     increasing the therapy-related toxicity or decreasing the patients QoL.~   "
95347|NCT02319122|"~     The aim of this randomized, stratified, single-blinded study is to compare two home based~     strength-training protocols (High Intensity Interval Training and Progressive Resistance~     Training) and their effects on muscle strength, gait and aerobic and anaerobic capacity in~     children with cerebral palsy.~   "
95348|NCT02319109|"~     This is a prospective, single-center study in healthy volunteers to establish a PT/INR~     reference interval for the Microvisk International Normalized Ratio (INR) Test System. The~     primary objective of this study is to establish the reference interval for the measurement of~     prothrombin time (PT/INR) using the Microvisk INR Test System. The second objective is to~     evaluate the safety of the device.~   "
95349|NCT02319096|"~     Pelvic floor muscle training (PFMT) is the first line therapy recommended by NICE for the~     treatment of SUI. Due to poor motivation and compliance only 15-20% of women comply with the~     regimen. Whole body vibration (WBV) exercise has been developed as a new modality in the~     field of physiotherapy. The Galileo machine is a unique device for applying whole-body~     vibration. The investigators are currently using this therapy as an alternative to~     traditional pelvic floor muscle therapy. The investigators aim to audit the investigators~     treatment of whole body vibration.~   "
95350|NCT02319083|"~     The E-CABG registry is a multicenter, European registry collecting data on the preoperative~     characteristics, treatment strategies and outcome of patients undergoing isolated coronary~     artery bypass grafting (CABG).~   "
95351|NCT02319070|"~     This study is a prospective, single center, observational, 2-cohort study of adult patients~     with severe Hemophilia A. There is no randomization procedure and all patients will be~     treated as per usual clinical practice. Patients will be followed up for 18 months after~     enrolment.~   "
95352|NCT02319057|"~     The purpose of this study is to evaluate ORM-12741 concentrations in the blood after~     different study drug formulations~   "
95353|NCT02319044|"~     The purpose of this study is to determine the efficacy and safety of investigational medical~     products (MEDI4736 monotherapy, tremelimumab monotherapy, and MEDI4736 + tremelimumab~     combination therapy) in the treatment of patients with recurrent or metastatic carcinoma of~     the head and neck who have progressed during or after treatment with a platinum containing~     regimen for recurrent/metastatic disease.~   "
95354|NCT02319031|"~     The purpose of the study is to determine if the combination of Daclatasvir, Sofosbuvir and~     Ribavirin for 12 or 16 weeks is safe and effective in the treatment of Genotype 3 Chronic~     Hepatitis C (HCV) in patients with advanced fibrosis or compensated cirrhosis. Patients in~     this study may have already been treated prior for HCV or may have never received treatment~     for their HCV.~   "
95355|NCT02319018|"~     This phase I trial studies the side effects and best dose of alisertib when given together~     with combination chemotherapy in treating patients with gastrointestinal tumors. Alisertib~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~     Drugs used in chemotherapy, such as fluorouracil, leucovorin calcium, oxaliplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Giving alisertib with more than one~     drug (combination chemotherapy) may be a better treatment for gastrointestinal tumors.~   "
95356|NCT02319005|"~     The purpose of this study was to evaluate the safety and efficacy of revusiran (ALN-TTRSC) in~     patients with transthyretin (TTR) mediated Familial Amyloidotic Cardiomyopathy. Dosing has~     been discontinued; patients are being followed-up for safety.~   "
95357|NCT02318992|"~     The objective of the study is to investigate the efficacy of fresh, frozen or lyophilized~     fecal microbiota transplantation (FMT) via colonoscopy in patients with recurrent C.~     difficile associated diarrhea (RCDAD). We will generate a frozen, lyophilized or fresh fecal~     microbiota transplantation (FMT) inoculum from well-screened healthy volunteer donors of ≥150~     gram/sample. Delivery of FMT will be performed colonoscopically. Fecal samples from donors~     and recipients will be saved for later metagenomic studies to characterize the microbiome of~     the gut in patients before and after FMT.~      Donors will be enrolled and screened at the Center for Infectious Disease laboratory for~     enteric pathogens at University of Texas School of Public Health (EPDL-UT-SPH) which is~     College American Pathologist and Clinical Laboratory Improvement Amendments certified~     laboratory. The donors will come from a variety of places, including the University of Texas~     School of Public Health. We will screen at least 70 donors to recruit at least 20 qualified~     donors.~      Recipients All patients to be treated must have a physician who is willing to care from them~     after discharge from our facility. Recipients will need to have insurance or be willing to~     self-pay for this therapy. Attending physician of recipients/patients will order the FMT and~     make clinical decisions related to overall health for his/her patients. All patients~     undergoing therapy will be handled as outpatients at either Baylor St. Luke's Medical Center~     in the Texas Medical Center, the Digestive Disease Center at Memorial Hermann in the Texas~     Medical Center, or Kelsey-Seybold Clinic - Main Campus on Holcombe Blvd. Once the procedure~     is completed, the recipient will be transferred back to their original medical treatment~     facility or be released to home care under the care of their physician. A gastroenterologist~     with privileges at Endoscopy procedure site will perform the FMT via colonoscopy. The Center~     for Infectious Disease enteric pathogens laboratory at the University of Texas School of~     Public Health will prepare donor stool for administration via a colonoscope. We will screen~     at least 120 recipients to recruit 100 qualified recipients.~      Evaluation of the safety of FMT and recurrence of clinical symptoms of CDAD will be performed~     by the primary physicians and research coordinators from the EPDL-UT-SPH. The primary~     endpoint is to evaluate the safety of the FMT (fresh or frozen or lyophilized health donor~     feces) for the treatment of patients with 3 or more episodes of RCDAD. A second efficacy~     endpoint is to evaluate the recurrence of clinical symptoms and CDAD after initial therapy.~     In order to monitor any health effects for safety, participants will be contacted quarterly~     for three years following study completion. The recipient will be contacted by the~     investigator pre- and approximately 7, 14 and 30 days after the procedure is performed. The~     following procedures will be completed: review recipient diary with the recipient to ensure~     that the following information is recorded correctly and a fresh stool sample will be~     collected from recipient, tested for C. difficile toxins and an aliquot (2 mL) stored at -80C~     for future analysis (e.g. microbiome). The recipients will be contacted by phone for their~     diarrhea status.~   "
96601|NCT02302742|"~     PROGECT is a registry for patients with Triple Negative breast cancer (TNBC) or patients who~     have an identified germline mutations (such as a mutation on the BRCA1 or BRCA2 genes).~   "
95362|NCT02318927|"~     The study objective is to explore Deep Brain Stimulation (DBS) in two specific brain regions~     (Globus Pallidum, or GPI, plus the pedunculopontine nucleus, or PPN) for on medication~     freezing of gait (FoG) in Parkinsons Disease (PD). Hopefully, information gathered from these~     two brain regions after surgery will allow for the development of a personalized DBS system~     to address FoG. The primary outcome will be a comparison of the pre-operative number of FoG~     episodes in the laboratory during the FoG battery versus those 6 months post-DBS at the~     optimized device settings.~   "
95363|NCT02318914|"~     The study will evaluate the long-term safety of gevokizumab in treating active PG ulcers~   "
95364|NCT02318901|"~     There will be two phase II cohorts for pembro plus trastuzumab: one cohort will be for~     patients with unresectable HER2 overexpressing gastric or GEJ cancers, the other cohort will~     be for patients with HER2 overexpressing metastatic breast cancer (MBC). The pembro plus~     ado-trastuzumab emtansine phase II arm will be for patients with HER2 overexpressing MBC.~     There will be two phase II cohorts for pembro plus cetuximab: one cohort will be for patients~     with HNSCC, the other cohort will be for patients with K-ras, B-raf, N-ras wildtype~     metastatic CRC.~   "
95365|NCT02318888|"~     The study aims at investigating if icodextrin 4% instilled in abdominal cavity during surgery~     can reduce the risk of surgery and hospitalisation for small bowel obstruction in patients~     with colorectal cancer. Follow-up data is collected from the Swedish national colorectal~     cancer registry.Patients are followed for 5 years postoperatively.The study is a randomized~     Swedish multicenter study and planned to include 1,800 patients. A safety control is planned~     after 300 included patients.~   "
95366|NCT02318875|"~     Joints and muscles disorders are common symptoms in the population. They are characterized by~     swelling, pain, functional impairment and morning stiffness. These disorders can be really~     disabling and painful, affecting the person's quality life. The purpose of this clinical~     trial is to test Kritech (Krill oil) efficacy in reducing these symptoms in 154 subjects~     complaining functional discomfort associated to joints and muscles disorders.~   "
95367|NCT02318862|"~     Gastroesophageal reflux disease (GERD) is a common condition affecting more than 100 million~     adults in the U.S., and it significantly impacts patients' quality of life while imposing~     billions of dollars of direct and indirect costs each year upon our healthcare system.~     Current diagnostic tests for GERD are highly invasive and medically inadequate, and the goal~     of this project is to develop a novel, minimally invasive Mucosal Impedance technique for~     more accurate detection of GERD while reducing costs.~   "
95368|NCT02318849|"~     Taking advantage of college students' frequent use of online technology, including social~     networking sites (e.g., Instagram a social media site /Facebook a social networking site) and~     social media sites (e.g., YouTube), we will create an online intervention that leverages this~     technology to engage and educate Asian, Native Hawaiian, Pacific Islanders (ANHPI)students~     about a range of topics related to organ donation following death.~   "
95369|NCT02318836|"~     This is a Phase 1, open-label, parallel-group, single-dose study of lofexidine in 6 adult~     subjects with mild hepatic impairment (Child Pugh score of 5 6), 6 adult subjects with~     moderate hepatic impairment (Child Pugh score 7 9), 6 adult subjects with severe hepatic~     impairment (Child Pugh score 10 15), and 6 control subjects with normal hepatic function with~     mean age, body mass index (BMI), and gender distribution targeted to be similar to the~     impaired hepatic function cohorts.~   "
95370|NCT02318823|"~     The present study aims to evaluate effects of beer (alcohol) on social cognition.~   "
95371|NCT02318810|"~     Mask ventilation during induction of anesthesia can be improved by administration of~     neuromuscular blocking agents (NMBAs). NMBAs are usually administered after testing mask~     ventilation; however, muscle relaxants may improve mask ventilation and they do not alter~     mask ventilation. Thus, growing evidence suggests to administer muscle relaxants before~     testing mask ventilation. We will study different dosages of rocuronium; we assume that~     higher dosages of rocuronium will improve mask ventilation compared with lower dosages.~   "
95372|NCT02318797|"~     Adults with serious mental illness (SMI) frequently have unmet medical needs which place them~     at risk for adverse health outcomes. While there are proven ways to manage and/or prevent~     serious medical conditions common among this population, information is needed to understand~     their impact on outcomes that matter most for patients, particularly in community mental~     health centers (CMHCs) where most adults with SMI receive their care and rural areas where~     locating and receiving health care services can be challenging.~      The investigators will test two promising ways for promoting the health, wellness, and~     recovery of adults with SMI. One way will help patients manage their health and health care~     through self-management strategies, including the use of a web portal, and peer support~     (patient self-directed care) and the other through interactions with nurses during clinic~     visits (provider-supported integrated care).~      The investigators will compare the two interventions on three primary patient-centered~     outcomes (i.e. patient activation in care, health status, engagement in primary/specialty~     care). The investigators hypothesize that:~        1. Patient self-directed care will result in improvement in patient activation.~        2. Provider-supported integrated care will result in greater improvement in frequency in~          primary/specialty care visits.~        3. Both interventions will result in significant improvements in the three primary~          outcomes.~      The investigators will collect information from patients, caregivers, and clinic staff at~     different points in time during the study. Patients will be asked to complete questionnaires~     and additional data on their service use will be gathered. Some patients and providers will~     also be interviewed about their experiences with care. The investigators will examine these~     data to learn if, how, and why the new services improve outcomes over time. This information~     will help us understand patient and other stakeholder views about the services and, if~     appropriate, ensure their continued and/or expanded availability.~   "
95373|NCT02318784|"~     The purpose of this study is to determine if carfilzomib is safe and effective in the~     treatment of patients with advanced neuroendocrine tumors.~   "
95374|NCT02318771|"~     This randomized clinical trial studies radiation therapy and MK-3475 in treating patients~     with head and neck cancer, kidney cancer, melanoma, or lung cancer that has returned, has~     spread to other parts of the body, or cannot be removed by surgery. Radiation therapy uses~     high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as MK-3475, may block~     tumor growth by targeting certain cells and causing the immune system to attack the tumor.~     Studying the effects of MK-3475 with radiation therapy on the body may help doctors learn~     whether it may be an effective treatment for these solid tumors.~   "
95375|NCT02318758|"~     A study to assess the interaction of acohol and oral treprostinil.~   "
95487|NCT02317289|"~     Freezing of gait (FOG) is a particular and troublesome symptom occurring in some Parkinsonian~     patients. Our objective is to adapt and extend FOG detectors in order to include other~     associated gait pattern changes, like festination.Our purpose is to develop a wearable~     assistant which would trigger the most appropriate cueing aid just before occurrence of the~     freezing episode.~   "
96664|NCT02301923|"~     This study aims to determine the average compliance of a patient under CPAP therapy for~     obstructive sleep apnea as well as the various factors that influence it.~   "
95376|NCT02318745|"~     This study seeks to investigate the efficacy and mechanisms of a highly promising Culturally~     Informed Family Therapy for Adolescents in preventing the emergence of two important health~     disparities in Hispanic youth, namely drug use & HIV and other sexually transmitted~     infections (STI). The proposed study is submitted as part of a P60 application entitled~     NCMHD Center for Culturally-Tailored Hispanic Health Disparities Research (El Centro), in~     response to the NIH RFA-MD-06-002: Establishing Comprehensive NCMHD Research Centers of~     Excellence.~      This study investigates: 1) the efficacy of the treatment in reducing existing psychiatric,~     behavioral and family problems in youth, and 2) the indicated prevention effects of the~     intervention on the emergence of drug use and HIV/STI 20 months after baseline. There is a~     substantial literature linking disruptive behaviors (i.e., conduct disorder and attention~     deficit hyperactivity disorder) and mood instability (i.e., depressive disorders) and family~     conflict to the development of the Hispanic health disparities of drug use and HIV/STI.~     Conduct disorder (CD), attention deficit hyperactivity disorder (ADHD) and depressive~     disorders (DD) will be targets of treatment, as will be the family risk factors (e.g., poor~     parenting, family conflict) and acculturation-related stressors, all of which have been shown~     to place youth on a destructive trajectory toward deteriorating health.~   "
95377|NCT02318732|"~     This study evaluates exposure to California's Armed and Prohibited Persons System (APPS) and~     risk of future violence and other important outcome events among individuals who legally~     purchased firearms in the past but have since become prohibited from owning them. The main~     hypothesis is that APPS will be associated with a significant reduction in risk for future~     violence among individuals who are directly affected.~   "
95378|NCT02318719|"~     Investigate the efficacy and safety of DS-5565 in subjects with Post-Herpetic Neuralgia (PHN)~     in comparison to placebo~   "
95379|NCT02318706|"~     Investigate the efficacy and safety of DS-5565 in subjects with Diabetic Peripheral~     Neuropathic Pain (DPNP) in comparison to placebo~   "
95380|NCT02318693|"~     This is a study of the efficacy of sitagliptin and glibenclamide in a short-term treatment on~     the glucose variability using continuous glucose monitoring (CGM) in Japanese participants~     with type 2 diabetes mellitus (T2DM). The primary hypothesis is that treatment with~     sitagliptin will be superior to treatment with glibenclamide in the change from baseline in~     mean amplitude of glycemic excursions (MAGE) through continuous glucose monitoring (CGM)~     after 13 days of treatment.~   "
95381|NCT02318680|"~     The study aims to assess whether a follow home visit after discharge of frail elderly~     patients from Nykøbing Falster Hospital reduces the risk of readmission within 180 days.~      Staff from the hospital ward identifies patients fulfilling the inclusion criteria and refers~     the patients to two project nurses at the hospital (follow home team). One of the project~     nurses gets the informed consent from the patient, or in case of a patient who is not able to~     give informed consent, from the family and general practitioner. The patient is then~     randomized to intervention (follow home visit after discharge) or control.~      In the intervention group, the hospital project nurse and the patient meets with the~     municipal nurse in the patient's home on the same day the patient is being discharged from~     the hospital. During this visit the discharge from the hospital and the actual functioning of~     the patient in his own surroundings is reviewed, using a structured assessment.~   "
95382|NCT02318667|"~     The purpose of this study is to evaluate serum soluble human Suppression of Tumorigenicity 2~     (ST2) protein, the receptor for IL-33 and a member of the proinflammatory IL-1 receptor~     superfamily, as a surrogate biological marker predictive of disease outcome and therapeutic~     response to golimumab treatment in subjects with moderate to severe UC who have failed on~     prior conventional therapies. The primary endpoints of this study are to correlate serum~     soluble ST2 levels with endoscopic activity (endoscopic subscore of the Mayo score) and~     histological activity (Geboes index) of disease.~   "
95383|NCT02318654|"~     The primary objective of this study is to compare the efficacy of ice pack to topical~     eutectic mixture of local anesthesia (EMLA) for pain control in diode 810 nm laser axillary~     hair removal.~      This study is a pilot study designed to determine feasibility of these procedures.~   "
95384|NCT02318641|"~     Retinal oximetry can be measured with newly developed Oxymap (Oxymap ehf, Reykjavik,~     Iceland). Briefly, the device simultaneously acquires digital images at two wavelengths and~     automatically tracks retinal vessels on both images. Retinal vessel oxygen saturation is~     estimated by spectrophotometric analysis of light reflected from retinal vessels and from the~     immediately surrounding retina. Oxygen saturation measurements are made on major temporal~     arteries and veins. Briefly, the first and second degree vessels are used, with the addition~     of third degree vessels in images where peripapillary haemorrhage prevented analysis close to~     the optic disc. Vessel segments chosen for analysis are used consistently for consecutive~     measurements in the same retina.~   "
95385|NCT02318628|"~     The aim of the 3A Study is to assess the role of MetS on the arterial mechanics and vascular~     health in different age groups using the Cardio Ankle Vascular Index (CAVI) of the Vasera~     system and the classic carotid-femoral Pulse Wave Velocity (PWV).~   "
95386|NCT02318615|"~     The purpose of this comparable cohort study is to evaluate the efficacy and safety of~     immediate axillary plasty with pedicled partial Latissimus Dorsi muscle flap for lymphedema~     prevention in breast cancer patients who are undergoing axillary dissection.~   "
95387|NCT02318602|"~     This is a multicenter, open-label trial to assess the long-term safety and efficacy of~     Cannabidiol Oral Solution as adjunctive therapy for pediatric and adult participants with~     treatment-resistant seizure disorders, including Lennox-Gastaut syndrome (LGS) or Dravet~     syndrome (DS). All participants have rolled over from previous trials: INS011-14-029~     (NCT02324673), INS011-14-024 (NCT02318537), or INS011- 14-025 (NCT02318563).~   "
95388|NCT02318589|"~     This Phase I trial will establish the recommended phase II dose of eribulin in combination~     with fixed doses of oral irinotecan in adolescents and young adults with relapsed or~     refractory solid tumors. Eribulin will be administered intravenously on days 1 and 8 of a~     21-day cycle, while irinotecan will be administered orally on days 1-5. Patients will be~     assigned an eribulin dose level at the time of enrollment using a 3 + 3 Phase I design.~   "
95389|NCT02318576|"~     This study seeks to examine whether 12 weeks of home-based computerized cognitive training on~     Cognitive Motor Interference (CMI) will improve walking and cognitive function in persons~     with MS.~   "
95390|NCT02318563|"~     This Phase 3 study will enroll participants diagnosed with Dravet Syndrome (DS) who are still~     experiencing at least one tonic-clonic, clonic, and/or focal seizures with motor components~     (FSMC) per week, despite ongoing treatment with up to three antiepileptic drugs (AEDs), and~     meet the other inclusion/exclusion criteria.~      Following a 28-day baseline period, participants will begin an 84-day treatment period.~     Participants will be assigned to receive twice-daily doses of placebo or cannabidiol oral~     solution at the highest dose determined to be safe in a previous trial.~      Following study completion, all participants will be invited to receive Cannabidiol Oral~     Solution in an open label extension study (under a separate protocol).~   "
95391|NCT02318550|"~     The purpose of the registry is to accumulate pre-and post-scan device interrogation data for~     the purpose of determining the risk of MRI for patients with implantable devices.~   "
95392|NCT02318537|"~     This Phase 3 trial will enroll participants diagnosed with Lennox-Gastaut Syndrome (LGS) who~     are still experiencing at least 4 motor seizures involving the trunk or extremities per week,~     despite ongoing treatment with up to 3 antiepileptic drugs (AEDs) and who meet~     inclusion/exclusion criteria.~      Following a 28-day baseline period, participants will begin an 84-day treatment period.~     Participants will be assigned to receive twice daily doses of placebo or cannabidiol oral~     solution at the highest dose determined to be safe in a previous trial.~      Following study completion, all participants will be invited to receive Cannabidiol Oral~     Solution in an open label extension study (under a separate protocol).~   "
95393|NCT02318524|"~     Fungal infections could play a role in chronic obstructive pulmonary disease (COPD) patient's~     exacerbations and in lung function impairment. In fact, Aspergillus fumigatus is often~     isolated from respiratory samples, but few data are available about its clinical~     significance. Aspergillus colonization could be associated to a higher risk of invasive~     pulmonary aspergillosis (IPA), which, in COPD patients, is characterized by a 2% incidence~     (probably underestimated) and a high mortality (72 to 95%). Similarly, detection of~     anti-Aspergillus antibodies is quite frequent in COPD patients but its significance and~     usefulness for aspergillosis diagnosis and follow-up have not been assessed. Furthermore,~     several studies suggest a frequent carriage of Pneumocystis jirovecii, reaching 37-55%, with~     a higher frequency in the most severe COPD stages and a possible role of colonisation in the~     occurrence and progression of COPD.~      As these colonization and sensitization phenomena could be related to domestic exposure to~     airborne or, for P. jirovecii, to human reservoirs, the investigators set-up a study in order~     to (i) Evaluate how domestic exposure to mould or to P. jirovecii could impact fungal~     colonization and sensitization frequency in COPD patients, (ii) Study the relationship~     between these fungal colonization/sensitization phenomena and lung function impairment in the~     course of COPD and (iii) Have a better understanding of mould and P. jirovecii circulation in~     the close environment of patients (between airborne, human reservoirs and patients).~      In fine, this study will provide data (i) On fungal contamination levels (species and conidia~     concentration) of COPD patient's homes in a French region, (ii) On the relationship between~     fungal exposure level and colonization/sensitization phenomena, (iii) On the role of fungal~     colonization/sensitization in lung function impairment, (iv) To design diagnostic,~     therapeutic, and preventive options for the management of COPD patients, taking into account~     fungal environmental exposure and colonization/sensitization impact on the evolution of the~     disease.~   "
95394|NCT02318511|"~     This is a Prospective, Randomized study evaluating the efficacy of ReNu for the treatment of~     Kellgren-Lawrence grade 2 or 3 osteoarthritis. Patients will be randomized into 1 of 3 groups~     for injection into the effected knee: 1) ReNu - study treatment, 2) Hyaluronic Acid (HA)~     injection - with commonly used injection material and 3) Saline. After treatment, patients~     will be followed up to 12 months to evaluate improvements using common pain and function~     subscales.~   "
95395|NCT02318498|"~     Myocardial infarction with angiographically normal coronary arteries (MINCA) is common (7-8 %~     of all myocardial infarctions). There are several different causes behind MINCA where true~     infarction due to thromboembolism, myocarditis or Takotsubo stress cardiomyopathy are the~     main findings. The underlying diagnosis is often made by clinical findings sometimes with the~     help of cardiac MRI (CMR). Investigators have previously shown that it was possible to give~     50 % of the patients a diagnosis made by the combination of clinical findings and CMR made in~     median 12 days after the acute event. The present study aim at improve the diagnostic~     accuracy by an early CMR with latest technique.~   "
95396|NCT02318485|"~     This project aims to conduct a multicentre human clinical trial to effectively diagnose and~     treat limbal stem cell deficiency (LSCD) which can be caused by a number of different disease~     processes, all of which have a common denominator, i.e. a loss of the normal functioning~     epithelial stem cells of the cornea. A number of different diseases such as aniridia, steven~     johnson's syndrome, ocular cicatricial pemphigoid, bacterial keratitis, or chemical and~     thermal injuries to the cornea can lead to gradual loss of its functioning epithelial stem~     cells. This leads to vascularization of the cornea with surrounding conjunctival epithelium~     growing over it resulting in its scarring and opacification. These corneas, since vascular,~     no longer retain their immune privilege and prove extremely challenging to the ophthalmic~     surgeon. Grafting donor corneas which in normal circumstances (non vascular corneas) would~     give excellent results, exhibit high rates of rejection. This can be very frustrating for~     both the patient as well as the surgeon. Since there are a number of different contributing~     disease pathologies, our estimate is that there are approximately 100 patients per year in~     Belgium that suffer from some degree of LSCD. These patients are very often not correctly~     diagnosed since this is a relatively new disease first described in 1990 after the discovery~     of limbal epithelial stem cells in 1989. The low rates of diagnosis could potentially be~     increased by in vivo confocal scanning microscopy as a non invasive screening test to detect~     early signs of LSCD and therefore offer conservative treatment options. In the cases where~     total limbal stem cell deficiency has already developed, conventional corneal grafting is not~     suitable due to the high vascularity of the host bed. In this situation we propose~     transplanting standardized limbal epithelial stem cell grafts generated from the patient's~     own ocular stem cells (from the good eye, where available) or from HLA matched donors. Tiny 1~     by 2mm superficial limbal (peripheral cornea) biopsy can be taken and the epithelial stem~     cells expanded in the laboratory on a biological substrate, until there is a graft measuring~     >8mm in diameter generated in 2 a week period. This can then be transplanted onto the~     diseased eye after removal of scar tissue using a novel surgical technique we have developed.~   "
95397|NCT02318472|"~     The purpose of this study is to determine whether early mobilization after Achilles tendon~     rupture can speed up healing and improve patient outcome.~   "
95398|NCT02318459|"~     This is a pilot study for evaluating the feasibility of using High Intensity Interval~     Training in geriatric hospitalized patients compared to the standard current rehabilitation~     practice.~   "
95399|NCT02318446|"~     The present study is planned to study effect of folic acid supplementation on homocysteine~     levels and CV risk factors such as BP and lipids in adolescent epileptics taking~     anti-epileptic drugs (AEDs).~   "
95400|NCT02318433|"~     The primary aim of the study is to see if a single wrist injection (intra-articular) of~     dexamethasone at the time of treatment will reduce the incidence of early-onset of post~     traumatic osteoarthritis.~   "
95488|NCT02317276|"~     The purpose of this study is to assess the differential expression of AD biomarkers in serum,~     plasma, and skin biopsies from both lesional and non-lesional skin in moderate to severe AD~     patients in the presence of TCS and after withdrawal from TCS.~   "
95489|NCT02317263|"~     This is a multicenter, prospective, placebo-controlled, double-blind randomized Phase II~     clinical trial assessing the effect of testosterone treatment vs. placebo treatment for 96~     weeks duration on whole brain atrophy in men with MS.~   "
95401|NCT02318420|"~     OVERALL OBJECTIVE In an East African referral hospital, to develop and analyze the effect of~     locally agreed and achievable guidelines and a continual in-house training program for~     strengthening partogram-based monitoring-to-action during labour.~      INTERVENTION Paper partograms (WHO), locally developed labour management guidelines (the~     PartoMa guidelines) and continual in-house education.~      OVERALL DESIGN A quasi-experimental pre-post-study (The PartoMa study).~      SETTING Department of Obstetrics and Gynaecology, Mnazi Mmoja Hospital, Zanzibar.~      POPULATION Labouring women delivering at the study site from October 2014 to January 2016 and~     their offspring, as well as health providers. Women and their offspring will be enrolled~     at/after unset of labour and followed until discharge.~      ENDPOINTS The primary composite endpoint is stillbirths and birth asphyxia. For further~     description and secondary outcomes, please see below.~      STUDY TIME Data collection from October 2014 to January 2016, supplemented by a post-exit~     collection of case file data from October 2016 - January 2017.~   "
95402|NCT02318407|"~     This is a sequential, randomized, double-blind, placebo controlled, multiple dose, dose~     escalation study in subjects with OA knee pain (n=32; 8/cohort). In each cohort, subjects~     will be randomized 3:1 to receive SC AMG 403 or placebo once every 4 weeks for a total of 4~     doses (Q28D x 4).~   "
95403|NCT02318394|"~     To evaluate the safety and tolerability of MEDI0562 in adult subjects with selected advanced~     solid tumors~   "
95404|NCT02318381|"~     Aim of this prospective double blind randomized clinical trial is to understand the~     correlation of suprascapular neuropathy in the setting of large and massive tears of the~     shoulder rotator cuff and to investigate whether arthroscopic dissection of the superior~     transverse scapular ligament is positively related to the improvement of this neuropathy.~   "
95405|NCT02318368|"~     Phase 2 multicenter, controlled, randomized, double-blind study to evaluate the efficacy and~     safety of ficlatuzumab versus placebo when administered with erlotinib in subjects with~     previously untreated metastatic EGFR-mutated NSCLC and BDX004 Positive Label.~   "
95406|NCT02318355|"~     This study is a randomized control trial in volunteer blood donors to quantify the effect of~     blood loss and subsequent crystalloid infusion on hemoglobin and markers of resuscitation~     such as base deficit and lactate.~   "
95407|NCT02318342|"~     This is a prospective study designed to evaluate the structural and functional integrity of~     transcatheter or surgical bioprosthetic valves with multimodality imaging. The study further~     aims to confirm resolution of the early bioprosthetic valve thrombotic changes with Vitamin K~     antagonists (warfarin) mediated anticoagulation therapy.~   "
95408|NCT02318329|"~     This is a three-part, open-label, safety, tolerability, and PK study of FPA144. Patients will~     be enrolled in Part 1 (A or B, dose escalation) or Part 2 (dose expansion) of the study, but~     not both.~   "
95409|NCT02318316|"~     The most effective treatment of hematologic malignancies and some benign hematological~     diseases is allogeneic stem cell transplantation therapy. Pulmonary complications can occur~     after allogeneic stem cell transplantation. And these complications effect mortality and~     morbidity in these patients. In this study we want to investigate the use of exhaled breath~     condensate (EBC) collection which is a simple and completely noninvasive method. By this way~     we hope to detect pulmonary complications early. EBC, has been implicated in the~     pathophysiology of inflammatory airway diseases such as cystic fibrosis, asthma, chronic~     obstructive pulmonary disease (COPD) and bronchiectasis. EBC, has not been investigated~     before in patients who underwent stem cell transplantation.~   "
95410|NCT02318303|"~     Study to evaluate the two different strengths and dose regimen of GSP 301 to be effective in~     treatment of seasonal allergic rhinitis.~   "
95411|NCT02318290|"~     Critically ill patients who are mechanically ventilated may require prolonged administration~     of sedatives and analgesics. Their prolonged use has been associated with withdrawal symptoms~     upon rapid weaning in critically ill patients. These withdrawal symptoms may be associated~     with adverse clinical outcomes. Although well studied in the paediatric population, little is~     known about the epidemiology, risk factors and optimal screening methods in adults. Studying~     this problem is essential as we strive to develop proper weaning strategies.~      Methods: Prospective observational two-center study in critically ill adult patients~     Objectives: 1) Describe the incidence of iatrogenic withdrawal of sedatives and analgesics in~     critically ill adult patients and 2) Evaluate the performance of screening tools assessing~     withdrawal that were developed for the paediatric patient in the adult population.~   "
95412|NCT02318277|"~     The purpose of this study is to explore the safety, tolerability, pharmacokinetics,~     immunogenicity and preliminary efficacy of INCB024360 administered in combination with~     MEDI4736 in subjects with selected advanced solid tumors.~   "
95413|NCT02318264|"~     This cross over design study will be used to determine the influence of elastic kinesiology~     tape on the speed and amplitude of quadriceps activation (anterior thigh) during selected~     resisted and weight bearing exercises.~   "
95414|NCT02318251|"~     The purpose of the present study is to compare two different physiotherapy programs regarding~     their effect on stress urinary incontinence.~   "
95415|NCT02318238|"~     The purpose of this study is to find an alternative to the six minute walk test by validating~     six minute step test and four metre gait speed in healthy children. Both tests were~     previously validated in adults and are easier to achieve in non-hospital settings.~   "
95416|NCT02318225|"~     The aim of this study is to assess whether vaginal misoprostol reduces pain during office~     hysteroscopy in parous patients with no risk factors for experiencing severe or unacceptable~     pain.~   "
95417|NCT02318212|"~     International Observational E-Registry on the use of osmotic dilators DILAPAN-S® / DILASOFT®~     for cervical priming prior to induced abortion.~   "
95418|NCT02318199|"~     Emergence agitation is a frequent complication that can have serious consequences during~     recovery from general anesthesia. However, agitation has been poorly investigated in patients~     after craniotomy. In this prospective multicenter cohort study, adult patients will be~     enrolled after craniotomy and emergence agitation will be evaluated. The incidence, risk~     factors and outcome will be investigated.~   "
95810|NCT02313064|"~     This will be the first-in-human (FIH) study with the oral formulation of CXA-10. The main~     purpose of this trial is to demonstrate the safety, tolerability and pharmacokinetics (PK) of~     CXA-10 and its metabolite(s) administered as single ascending oral doses to healthy~     volunteers (Part A). The effects of food on the PK of CXA-10 will also be investigated (Part~     B).~   "
95419|NCT02318186|"~     Abstract~      This is a multi-center, open-label pharmacokinetic (PK) study examining the relationship~     between the steady-state plasma concentration and dose of treprostinil delivered~     intravenously or subcutaneously in children with pulmonary arterial hypertension (PAH).~     Subjects will be divided into 5 cohorts by age. A blood sample will be obtained from each~     subject at steady state. Additional blood samples will be obtained from a small subset of~     subjects with a 15% increase or with at least a 15ng/kg/min increase in dose from steady~     state. Samples will be sent to a pharmacokinetic laboratory for analysis. Linear regression~     analysis will be used to determine the relationship between the steady state plasma~     concentration and drug dose. A power model will be used to assess dose proportionality.~   "
95420|NCT02318173|"~     International Observational E-Registry on the use of DILAPAN-S® osmotic dilator / DILASOFT®~     osmotic dilator for cervical ripening prior to labour induction.~   "
95421|NCT02318160|"~     Oxidative status in autoimmune thyroiditis was not investigated previously in children and~     adolescents. We investigated oxidant and antioxidant systems in a cohort of Egyptian children~     and adolescents with AIT to explore their relation with biomarkers of autoimmunity and~     thyroid function.~   "
95422|NCT02318147|"~     Infectious complications are responsible for most of deaths in acute pancreatitis.Intestinal~     barrier dysfunction and increased intestinal permeability was associated with bacterial~     translocation which is believed to prompted these infections.The purpose of this clinical~     trail is to observe the potential capability of FMT in reduce the bacterial translocation and~     alleviate infectious complications by the reconstruction of a gut functional state.~   "
95423|NCT02318134|"~     The intestinal microbiota plays a pivotal role in the maintenance of intestinal homeostasis~     and protecting the gut against pathogens by competing for nutrients, creating the intestinal~     biological barrier and modulating the host immune system.After the onset of acute~     pancreatitis,the intestinal hypoperfusion and the release of inflammatory mediators result in~     intestinal barrier dysfunction and intestinal bacteria dysbiosis.This leads to Bacterial and~     endotoxin translocation, which may cause infectious complications which are major causes of~     death in SAP patients.Recently,FMT was shown its efficacy in the treatment of~     gastrointestinal(GI) diseases and non-GI disorders associated with Intestinal flora~     disturbance by re-establishing the damaged Intestinal Bacteria homeostasis.However,the~     mechanism by which FMT results in cure of diseases has been poorly understood.This study aims~     to investigate the therapeutic potential of FMT for SAP patients with intestinal barrier~     dysfunction.~   "
95424|NCT02318121|"~     Prolonged labour is a cause of maternal mortality and morbidity and perinatal mortality and~     morbidity. Prolonged labour is most often defined as onset of regular , rhythmical painful~     contractions accompanied by cervical dilatation where labour is longer than 24~     hours.prolonged active phase should not last longer than 12 hours without full assessment in~     a facility able to offer management and treatment of complications.Causes of prolonged labour~     usually due to poor or uncoordinated uterine action , fetal head malposition , and or~     abnormal pelvis either due to bone or soft tissue obstruction.~      Arrested or prolonged labor is a frequent indication of cesarean delivery.Prolonged labor is~     also associated with increased pain and negative birth experience. Women with a prolonged~     first stage of labor have experienced a higher rate of postpartum hemorrhage,~     chorioamnionitis and neonatal admission to the intensive care unit.~      Caesarean section rates are over 20% in many developed countries and have increased nearly~     four-fold relative to the 5% rate observed in the early 1970s. The main diagnosis~     contributing to this increase is dystocia or prolonged labor.Data obtained from local~     hospital records showed that Caesarean section rate in Assiut University Women's Health~     Hospital is 47.96% at 2013.~      Dystocia is a term used for delay of labor progress and usually refers to abnormally slow~     cervical dilatation.It has been proposed that the partogram should include, as a diagnostic~     criterion, a 1 cm/hour line originating at admission. The World Health Organization has~     proposed a modified partogram that recommends that active phase be diagnosed only at 4 cm or~     more.~      Oxytocin augmentation of uterine contractions with or without amniotomy is widely used in the~     modern obstetric practice to treat a slow labour, although the timing of oxytocin initiation~     and amniotomy may vary widely.This intervention is based on the hypothesis that the most~     frequent cause of dystocia is inadequate uterine contraction.~      The mechanism by which amniotomy speeds up labour remains unclear it is thought that when the~     membranes are ruptured ,the production and release of prostaglandins and oxytocin increases~     resulting in stronger contractions and quicker cervical dilatation. I has been found that~     early intervention (augmentation versus routine care ) with amniotomy and oxytocin to be~     associated with a modest reduction in the risk of caesarean section. Moreover, amniotomy~     found to be associated with an increased risk of cesarean delivery compared with women~     without amniotomy for shortening of spontaneous labour.~      The 3 methods ( Amniotomy, Oxytocin or both) used for augmentation of labor in different~     settings without a real conclusion which is better.~   "
95425|NCT02318108|"~     The purpose of this study is to test the effectiveness and cost effectiveness of an assisted~     work process redesign intervention in achieving improved diabetes care in primary care~     practices. The strategies that we will test represent a novel method for assisting practices~     in developing the skills to overcome clinical inertia and health care system barriers to~     improved diabetes care by helping them to implement and use a diabetes registry to identify~     needed clinical or preventive services an opportunities for treatment intensification where~     appropriate for their patients with diabetes. This is accomplished by helping practices~     develop methods for improving the efficiency and effectiveness of clinical care processes~     through integration of a diabetes registry into regular clinical practice. This integration~     is accomplished through changes in the work processes in the practice setting to ensure that~     population health tasks (such as outreach to patients who do not attend scheduled chronic~     care visits and systematic identification for follow up of patients who may not be taking~     prescribed medication therapies) become a part of the regular work of clinical support staff~     and other members of the primary care practice team.~   "
95426|NCT02318095|"~     This research protocol will evaluate the feasibility of administering neoadjuvant gemcitabine~     and nab-paclitaxel with hypofractionated, image guided, intensity modulated radiotherapy~     (HIGRT) in resectable and borderline resectable pancreatic cancer~   "
95427|NCT02318082|"~     This research study is a way of gaining new knowledge about the treatment for cGVHD that has~     not responded to steroids. This research study is evaluating a drug called Interleukin-2~     (IL-2) as a possible treatment for cGVHD. In this Phase I study, the investigators are~     looking to see if 8- week individual patient dose- escalated IL-2 therapy for cGVHD is safe~     and its effects on your immune cells.~   "
95526|NCT02316782|"~     The purpose of this research study is to determine if Intravascular Ultrasound (IVUS)~     grayscale and VH (Virtual Histology)-IVUS pre-stenting can assess more accurately the~     location, amount, and type of a blockage than angiogram alone. Additionally, this study is to~     determine if IVUS grayscale and VH-IVUS guidance will result in improved acute and long term~     procedural outcome vs. bifurcation stenting with only angiographic guidance in native~     coronary arteries.~   "
96313|NCT02306499|"~     This study will include cryopreserved sperm from infertile azoospermic men, with proven~     diagnosis of varicocele (clinical & sonographic), which will be used for ICSI in an ART~     program in Sohag. Patients personal and medical history and socio-demographic data will be~     retrieved from their saved medical files.~   "
95428|NCT02318069|"~     The risk for tick borne encephalitis increases in Sweden. Together with an increased~     awareness of the possibility to acquire protection by vaccination, this has led to an~     increase in the number of doses of the vaccine distributed in Sweden each year - now being~     approximately 400.000. The first year, two doses with an interval of 1 month is recommended~     for the general population, followed by a third dose approximately one year later and an~     additional booster dose three years after the third.~      Preliminary results from a previous study showed a higher percentage protected (=titer at~     least 10) after 3 doses than after 2 doses (Rombo et al. EUDRA CT 2011 001348-31, unpublished~     information). In the same study, there were no differences between those who were vaccinated~     0+7+21 compared to 0+30+90. The investigators were surprised to find marked differences~     between 2 and 3 doses also in the younger control group.~      The investigators therefore aim to confirm results in a new study and to add a group with a~     double dose at day 0 and then a single dose at day 30 and 360~   "
95429|NCT02318056|"~     Specific Aim 1: To determine if one of three burn dressings provides a less painful healing~     experience for partial thickness hand.~      Specific Aim 2: To evaluate if one of three dressings provides greater functionality during~     and after healing of partial thickness hand burns.~      Specific Aim 3: To determine if one of three burn dressings promotes aesthetically superior~     healing results for partial thickness hand burns.~   "
95430|NCT02318043|"~     Adenosine monophosphate (AMP) may reflect airway inflammation and hyperresponsiveness, but~     relationship between AMP and histamine (His, a conventional stimulus) bronchial provocation~     test (BPT) in asthma is not fully elucidated.~      The investigators aimed to compare both BPTs and determine their usefulness in reflecting~     changes of asthmatic symptoms.~      BPTs were performed in cross-over fashion, at 2-4day intervals. Cumulative doses eliciting~     20% FEV1fall (PD20FEV1), diagnostic performance and adverse events were compared. Patients~     with PD20FEV1 lower than geometric mean were defined as responders, otherwise poor~     responders. Patients with uncontrolled and partly controlled asthma, who maintained their~     original inhaled corticosteroids therapy, underwent reassessment of airway responsiveness and~     asthmatic symptoms 3 and 6 months after.~   "
95431|NCT02318030|"~     Adequate control of immunosuppression is critical in preventing graft failure after solid~     organ transplantation (SOT) and in avoiding life-threatening viral and malignant~     complications. Prolonging patient and graft survival and delaying re-transplantation as~     children reach adulthood is critical to optimal use of a scarce resource. This requires~     tailoring post-transplant management to the unique needs of the child. Immunosuppression~     management is challenging in infants, children and youth. The interval from birth to young~     adulthood sees profound changes in physiological processes, body size and immune maturation;~     infancy and adolescence are the periods of most rapid and dramatic change. Three pivotal~     factors affect immunosuppression control in the child: 1) age-dependent variation in drug~     metabolism; 2) developmental changes in immune function with increased childhood~     susceptibility to infections, including those caused by viruses; and 3) behavioural changes~     in adolescence and young adulthood linked with poor treatment adherence.~      This project will identify the most important factors influencing immunosuppression control~     across the pediatric age range, from infancy to young adulthood, including age-related~     changes in drug metabolism, immune function, and susceptibility to viral infections, as well~     as health care system factors affecting treatment adherence. This is the first comprehensive,~     multi-organ transplant study to identify age-related biologic and health care systems~     determinants of variability in immunosuppression control in children and youth. Results will~     inform personalized age-appropriate strategies to improve immunosuppression control and~     reduce the unacceptably high graft failure and viral complication rates in this vulnerable~     population.~      The POSITIVE Study brings together researchers across Canada and is one of 6 projects and 3~     cores that constitute the Canadian Institute of Health Research (CIHR) funded~     interdisciplinary research program called the Canadian National Transplant Research Program~     (CNTRP). The CNTRP is a national program designed to increase organ and tissue donation in~     Canada and enhance the survival and quality of life of Canadians who receive transplants. As~     a national program, CNTRP provides robust power for pediatric studies that would not~     otherwise be possible. While primarily focused on issues unique to a pediatric and young~     adult population, this study will interact closely with all other CNTRP projects. These~     reciprocal interactions will accelerate new discovery that can be cross-applied in different~     populations outside of pre-specified age groups. Interactions will ensure rapid knowledge~     transfer, uptake and dissemination into practice. This is the largest national cohort study~     of pediatric transplant patients to date in Canada, and it will create a longitudinal dataset~     with clinical and biological specimens linkable to transplant registries and provincial~     administrative datasets.~   "
95432|NCT02318017|"~     In the current study, we will administer three widely administered cognitive tasks while~     simultaneously measuring electroencephalography (EEG) in ADHD patients before and after~     methylphenidate immediate release (IR) treatment compared to placebo. In addition we will~     compare the effective connectivity dynamics to normal subjects. Using this novel network~     analysis approach, we will attempt to address the currently limited cognitive network~     literature. We will attempt to map the connectivity between the discrete brain regions during~     the execution of the tasks before and after treatment with methylphenidate IR. Comparison~     with healthy control subjects will enable us to determine whether the direction of~     methylphenidate induced changes in brain functioning (in youths with ADHD) will be toward or~     away from normal connectivity patterns. We will also examine whether network patterns differ~     between the healthy controls and the ADHD patients.~   "
95433|NCT02318004|"~     The aims of the present study are to evaluate the information obtained by the EarlySenese~     monitoring system and examine correlation of the obtained data and clinical events.~   "
95434|NCT02317991|"~     The purpose of this study is to determine whether nab-Paclitaxel (Abraxane®) and ramucirumab~     (Cyramza®) are effective when used in combination for treating patients with metastatic~     gastroesophageal cancer who have either progressed or not responded to prior therapy.~   "
95435|NCT02317978|"~     Records of women who had in vitro fertilization (IVF) or intra-cytoplasmic sperm injection~     (ICSI) in Dar AlTeb sub-fertility center will be reviewed and the follicular sensitivity~     index (FSI) will be calculated and correlated with pregnancy.~   "
95436|NCT02317965|"~     The purpose of this study is to detect whole chromosome abnormalities in maternal blood.~   "
95437|NCT02317952|"~     The purpose of this study is to determine if a new extensively hydrolyzed formula can be~     consumed by children with Cow's Milk Allergy.~   "
95438|NCT02317939|"~     A two-step multi-centre study with 240 rheumatoid arthritis patients.~   "
95527|NCT02316769|"~     In this study, the investigators compare the effectiveness of two relatively new video~     laryngoscopes, McGrath MAC (Covidien, Dublin Ireland) and the King Vision (King Systems,~     Noblesville, IN), by practitioners experienced in airway management but with limited exposure~     to these two devices. Our hypothesis was that, the McGrath MAC device would require fewer~     intubation attempts and shorter intubation times than the King Vision when performed by~     novice users.~   "
95528|NCT02316756|"~     This is first in human (FIH), double-blind, sponsor open, placebo-control trial to examine~     the safety, tolerability, pharmacokinetics and pharmacodynamics following a single ascending~     doses of PF-06648671 in healthy subjects.~   "
95439|NCT02317926|"~     The proposed study design is a prospective, randomized, double-blind, crossover study. After~     informed consent is obtained, patients will be randomized to receive either desiccated~     thyroid in capsules, or L-T4/L-T3 (ThyrolarTM) in capsules, or L-T4 alone capsules. All study~     participants, physician investigators, those administering the neurocognitive tests and those~     analyzing test results will be blinded throughout the study.~      Subjects will undergo memory testing, a disease specific symptom questionnaire, a general~     mental health assessment, a complete physical examination, baseline EKG, and biochemical~     testing consisting of serum TSH, free T4, total T4, total T3, free T3, T3 resin uptake,~     reverse T3, sex hormone binding globulin (SHBG), serum iodine, a lipid panel, insulin,~     glucose and leptin. This testing and DXA scan of body composition will be performed at~     baseline and after each 3 month treatment period. Deiodinase type 2 (DIO2) polymorphisms~     analyses - will also be performed at the beginning of the study and the results will be~     blinded to the investigators performing the memory testing.~      After 5-6 weeks on the study medication, TSH levels will be checked and the medication~     adjusted to maintain TSH level between 0.46-4.68 mIU/L. Once the TSH level is in the desired~     range, subjects will continue the medication for an additional 6 weeks. Subjects will then be~     crossed-over to the other treatment arm for 3 months. Again, testing will be performed after~     each treatment period. Finally the subjects will again switched over to the 3rd arm and~     testing will be performed after treatment period.~      A cross-over design is preferred because we are assessing subjective symptoms such as~     clinical well-being and other parameters. Therefore, we will be able to evaluate the~     effectiveness of L-T4/T3 (ThyrolarTM) vs DTE vs T4 alone in the same patientssubjects. This~     is also supported by the previous study by Escobar-Morreale et al.~      Additionally, the Wechsler memory scale, DEXA for body composition, measurment of reverse T3,~     insulin, leptin, and DIO2 polymorphisms analysis will be included for the research portion of~     this study. Further, the frequency of serum blood draws, for research purposes, will be at~     intervals of 0, 6, 12, 18, 24, 30 and 36 weeks.~   "
95440|NCT02317913|"~     To investigate the epidemiological pictures of Kawasaki disease (KD) in Shanghai from 2008~     through 2012, and illustrate the risk factors of coronary arterial lesions .~   "
95441|NCT02317900|"~     Dengue viruses are widespread in most tropical and subtropical regions of the world. This~     study will evaluate the safety and protective efficacy of a dengue vaccine (called TV005)~     against viremia and rash induced by a DENV-2 vaccine virus (called rDEN2∆30-7169) in healthy~     adults.~   "
95442|NCT02317887|"~     Background:~      - X-linked juvenile retinoschisis (XLRS) is caused by changes in the RS1 gene. These changes~     cause abnormal function of the eye protein retinoschisin. Without normal retinoschisin, the~     layers of the retina split and vision is lost. Researchers want to try to introduce a healthy~     RS1 gene into eye cells, to see if this helps retinal cells make healthy retinoschisin. They~     will put the gene in a virus. The gene and virus package is known as a gene transfer vector~     (AAV-RS1 vector).~      Objectives:~      - To see if the AAV-RS1 vector is safe to use in people.~      Eligibility:~      - Adults 18 and older with a mutation of the RS1 gene, 20/63 vision or worse in one eye, and~     XLRS.~      Design:~        -  Participants will be screened with genetic tests to confirm XLRS. They will have a~          medical history and physical and eye exams.~        -  At visits 1-2, participants will have some or all of the following:~        -  Medical history~        -  Physical exam~        -  Blood and urine tests~        -  Tuberculosis skin test~        -  Eye exam~        -  Vision tests (for one test an intravenous line will be placed in the arm. A dye will be~          injected that will travel to the blood vessels in the eye).~        -  At visit 3, the AAV-RS1 vector will be injected with a needle in the study eye.~          Participants pupils will be dilated. They will get numbing eye drops.~        -  Visits 4-13 will occur in the 18 months after gene transfer. Many of the above tests~          will be repeated. Participants will discuss any side effects.~        -  Visits 14-17 will occur yearly between years 2 and 5.~        -  After year 5, participants will be contacted yearly by phone for up to 15 years.~   "
95443|NCT02317874|"~     This phase I trial studies the side effects and best dose of talazoparib when given together~     with carboplatin and paclitaxel in treating patients with solid tumors that have spread to~     other places in the body or cannot be removed by surgery. Talazoparib may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth~     of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Giving talazoparib with carboplatin and paclitaxel may kill more tumor~     cells.~   "
95444|NCT02317861|"~     The purpose of this study is to explore the pharmacodynamics (PD), pharmacokinetics (PK),~     safety, and tolerability of multiple doses of RDEA3170 administered in combination with~     febuxostat compared to RDEA3170 administered alone and febuxostat administered alone in~     Japanese adult male subjects with gout or asymptomatic hyperuricemia.~   "
95445|NCT02317848|"~     The prevalence of sleep-disordered breathing is common in patients with stable chronic heart~     failure (up to 83%). Basically, the SAS is divided into two categories: central SAS (CSAS)~     and obstructive SAS (OSAS). The two can coexist. In patients with CHF, the presence of SAS is~     associated with higher mortality.~      CHF is associated with a high rate of re-hospitalization and significant morbidity and~     mortality and is considered as a major medical and economic problem. To date, few studies~     have investigated the prevalence, severity, persistence and the role of SAS during cardiac~     decompensation. For different pathophysiological considerations, it is assumed that SAS is~     exacerbated during AHF. Therefore SAS is not conventionally screened during this phase. This~     assumption has been questioned recently by some studies which showed stability of the type of~     SAS and its severity between the decompensation episode and the stable HF.~      Our hypothesis is that SAS during an AHF episode of CHF will remain stable both in terms of~     severity and type at three months of decompensation. Thus early polygraphy may be reliable~     for identifying HF patients with SAS.~   "
95446|NCT02317835|"~     To evaluate a recently developed non-invasive infrared thermal camera called Diabetic Foot~     Ulcer Prevention System (DFUPS) in a clinical setting by studying healthy volunteers.~   "
95447|NCT02317809|"~     Some women cannot have children because they cannot produce enough follicle stimulating~     hormone (FSH) and luteinising hormone (LH). When this happens the ovaries fail to produce an~     egg during the menstrual cycle - a condition known as anovulation. Anovulation can be treated~     by giving replacement FSH and LH. Pergoveris is a medication that contains both FSH and LH.~     It is used for the treatment of anovulation in women who do not produce enough FSH and LH.~      A new, liquid formulation of Pergoveris is being tested in this study. It will be compared~     with the current freeze-dried marketed formulation to see if the new formulation gets into~     the blood stream as easily as the current formulation.~      This study will involve 38 healthy female subjects and 2 treatment periods and will last for~     approximately 77 days. Each subject will receive a single dose of the new liquid formulation~     and a single dose of the current marketed formulation separated by an interval of two weeks~     in a randomised (by chance) order. Blood samples will be taken at regular intervals over 2~     weeks after each dose to measure levels of FSH and LH.~      To participate female subjects must have normal ovaries on internal ultrasound scan, a normal~     result from a cervical smear test, be taking the combined oral contraceptive (OC) pill.~      Eligible subjects will have their usual OC pill replaced with another called Marvelon~     throughout the study. After 14 days subjects will have their levels of FSH and LH checked and~     if sufficiently reduced will only then proceed to dosing.~      Subjects will then receive one of the formulations. An ultrasound scan of the ovaries will be~     performed 7 days later, and another one 7 days later just before the next dose. Subjects~     whose ovaries show signs of stimulation will not be given the second dose. The ultrasound~     scan will be repeated 7 days after the second dose.~   "
95454|NCT02317718|"~     Vitamin D has a major play in bone and calcium metabolism. Vitamin D deficiency (below 20~     ng/ml) has also been linked to adverse health outcomes such as malignancy, cardiovascular~     disease, immune functioning, and glucose metabolism. Recent data from retrospective and~     prospective trials have demonstrated contradictive results concerning the role of vitamin D~     in female reproduction and IVF outcome. Some studies have found that women deficient in~     vitamin D had lower ovarian reserve and significantly lower clinical pregnancy rates when~     compared to patients who were sufficient levels in vitamin D. Some studies also demonstrated~     that serum 25-OH-D3 levels correlates with antimullerian hormone (AMH) levels in women of~     advanced reproductive age. It may also have a role to play in endocrine dysfunction and~     abnormal folliculogenesis in polycystic ovaries .~      The aim of this prospective cohort study including infertile women undergoing IVF treatment~     is to investigate the association between serum 25-OH- D3 levels and parametres of ovarian~     reserve (AMH, antral follicle count, number of oocytes collected) and clinical pregnancy and~     miscarriage rates .~   "
95455|NCT02317705|"~     This study is being done to:~        -  test the safety of OTL38~        -  see if OTL38 helps light up the cancer when viewed with the special camera system~        -  test the safety of the special camera system for use along with OTL38 during surgery~   "
95456|NCT02317692|"~     The current pilot study aims to close the existing gap in our knowledge about effective~     psychosocial treatments for Latino families by providing preliminary data regarding the~     acceptability and efficacy of a culturally-modified ADHD treatment and possible moderators~     that will support a future R01. Specifically, the current pilot study is the first step in a~     larger program of research aimed at definitively determining if culturally-modified ADHD~     treatment outperforms standard treatment when examining engagement and acceptability~     outcomes, as well as symptomatology and parental functioning, and if so, which treatment~     modifications are necessary and for whom. The following study aims will be examined.~        1. Aim 1 is to explore if the culturally-modified treatment results in better engagement~          and acceptability outcomes (i.e., parental attendance, retention, engagement, and~          satisfaction) than standard treatment and to determine the strength of these effects.~        2. Aim 2 is to explore if the culturally-modified treatment results in improvements in ADHD~          symptomatology, as well as parental functioning (i.e., parenting stress and efficacy),~          to explore if the modified treatment results in similar or greater improvements than~          standard treatment, and to determine the strength of these effects.~        3. Aim 3 is to explore possible moderators (i.e., socioeconomic status (SES) and behavioral~          and cognitive acculturation) that may explain the relationship between treatment type~          (i.e., standard versus culturally-modified) and outcomes and to determine the strength~          of these interactions.~   "
95457|NCT02317679|"~     Pulsed dye laser (PDL) is the gold standard treatment for port-wine stains (PWS). However,~     the outcomes are highly variable due to the new angiogenesis occurring after laser~     irradiation. Studies suggest that endothelin is involved in the neoangiogenesis that occurred~     after treatment of port-wine stains by PDL. The main objective of this pilot clinical trial~     is to evaluate the effectiveness and safety of an inhibitor of endothelin orally taken, the~     Bosentan, following PDL treatment. Four patients with facial port-wine stain resistant to the~     PDL treatment will be included. The treatment by Bosentan (2 mg/kg twice daily, maximum 62,5~     mg twice daily) will be given one day before the PDL irradiation and continued for 14 days.~     Only one test area of PWS will be treated with PDL. The primary outcome measure will be an~     important or complete improvement (Investigator Global Assessment 3 or 4) between treated~     area and non treated one, 14 days after the end of the treatment which corresponds to one~     month after the laser PDL session. The evaluation will been performed on standardized~     pictures by 2 independent physicians blinded to the region treated or not.~   "
95458|NCT02317666|"~     Older people often use medications with anticholinergic or sedative side effects which~     increase the risk of falling, fractures caused by falls and cognitive impairment. In the~     Netherlands, medication reviews are done by pharmacists in collaboration with the general~     practitioner to optimize medication use and reduce these adverse drug events. To maximize the~     benefits of medication reviews it is helpful to identify patients with high risk medication,~     yet few appropriate tools are available The Drug Burden Index (DBI) designed in Australia,~     calculates anticholinergic and sedative drug burden. This study evaluates whether the DBI can~     be used to identify patients with anticholinergic and sedative medication in need of a~     medication review. A clustered randomized controlled intervention study will be conducted.~     Per pharmacy (cluster), one pharmacist will perform the medication reviews. In each pharmacy,~     one half of eligible patients will be randomly allocated to the control group and the other~     half in the intervention group. Data will be collected at baseline and at follow-up, 3 months~     after the medication review has taken place. The study population includes community-dwelling~     patients aged ≥ 65, with polypharmacy (≥ 5 medications) and a DBI value ≥ 1 (n = 190)~     selected by 10 community pharmacists. The intervention consists of a structured 5-step~     multidisciplinary medication review (STRIP method) as described in the multidisciplinary~     guidelines of Dutch General Practitioners performed by the pharmacist in collaboration with~     the general practitioner. The main endpoint is the difference in proportion of patients~     having a decrease of the DBI ≥ 0.5 between the intervention and control group at 3 months~     follow up. Secondary outcomes are anticholinergic side effects, risk of falls, cognitive~     function, function of daily activity, hospital admission and mortality. All participants will~     be informed about the study and asked to provide informed consent. Data will be processed~     confidentially. Only the researcher will have access to the data. If required, the Dutch~     Inspection of Healthcare will also be granted access to the data for Inspection. The burden~     of patients will be kept at a minimum by trying to retrieve as much information as possible~     from patient's medical records and by using questionnaires and tests that were specifically~     developed for this population. In the investigators opinion, participation does not involve~     risks.~   "
95459|NCT02317653|"~     The purpose of this study is to identify the influences of pregnancy on breast milk and the~     effects of these on the health of babies during the first 2 months of life. The investigators~     hypothesize that overweight and obese mothers will have lower serum n-3 to n-6 PUFA ratios~     during pregnancy and postpartum than normal weight mothers and will be positively correlated~     with TNF-α, IL-1β, resistin, and negatively correlated ghrelin levels both in serum and in~     breast milk in postpartum.~   "
95460|NCT02317640|"~     The aim of this study is to understand what happens to muscle and bone in spinal cord injured~     males after four months of training using stand training, with body weight support (BWS),~     with testosterone replacement therapy (TRT), and electrical stimulation (ES). Specifically,~     researchers will investigate nerve, muscle, and bone changes in the lower limbs in response~     to stand training and ES when combined with TRT compared to i) standing alone with TRT; ii)~     stand training alone with placebo; iii) stand training alone and ES with placebo.~   "
95461|NCT02317627|"~     This study is being done to evaluate the safety, tolerability, activity, pharmacokinetics~     (PK), and daily dose regimen of KD025 administered orally for 12 weeks to subjects with~     psoriasis vulgaris who have failed at least one line of systemic therapy.~   "
95462|NCT02317614|"~     Antiretroviral therapy (ART) increases life expectancy and quality of life for individuals~     infected with HIV, and can reduce the chance of HIV transmission, but a high degree of~     adherence to ART is required to achieve these benefits. Unfortunately, only 59% of patients~     in North America report ART adherence >90%. Thus, ART adherence interventions are a critical~     part of the fight against HIV/AIDS. Injection drug use and crack cocaine use are major~     factors in the transmission of HIV, and are associated with non-adherence to ART. Several~     types of interventions, most notably directly administered antiretroviral therapy (direct~     observation of antiretroviral administration and patient supports) and contingency management~     (the provision of incentives contingent upon objective evidence of adherence) have been~     effective in promoting ART adherence in drug users. However, a core problem with all ART~     adherence interventions is that their effects do not last after the interventions are~     discontinued. The common finding of post-intervention dissipation of effects suggests that~     ART adherence interventions may need to be long-term or even permanent adjuncts to ART for~     drug users. The investigators intend to develop an intensive intervention that incorporates~     the most effective techniques for promoting ART adherence in drug users, and delivers them in~     a manner that allows for their large-scale implementation as long-term or even permanent~     adjuncts to ART. Thus, we will bundle a targeted group of effective component interventions~     into a smartphone application that is easy for patients to use, simple to manage, and~     maximally convenient for all stakeholders. Our ultimate goal is to produce an intervention~     that is highly effective and scalable. Toward that end, the SteadyRX intervention to be~     developed under this project will be largely automated and will (1) facilitate consultation~     with care providers (2) provide reminders when a dose is overdue, (3) provide electronic~     remote observation of medication-taking, and (4) reward ART adherence. In addition to~     developing this smartphone-based intervention, a pilot study will be conducted in 50 HIV+~     adults with a detectable viral load who use drugs or are in drug treatment. In this study,~     participants will be randomly assigned to receive usual care, or usual care plus the SteadyRX~     intervention.~   "
95463|NCT02317601|"~     The Study is a double-blinded, randomized, placebo-controlled trials. The Objective is to~     investigate the effect of single-high-dose glucocorticoid on surgical stress response and~     postoperative delirium among Elderly hip Fracture Patients undergoing surgery.~   "
95464|NCT02317588|"~     This study is single site, double-blind, randomized, cross-over study designed to compare the~     effects of flax oil and fish oil supplementation on the oxylipin profile in healthy males and~     females. Eligible participants will complete two (2) Supplementation Phases (flax oil versus~     fish oil) and will be asked to attend 6 in-person clinic visits (0, 1, 3, 7, 14 and 28 days)~     for blood and urine collection during each phase. Participants will consume 8 capsules a day~     for 28 days containing either A) Flax Oil at 4 grams of ALA per day ,in one phase and B) Fish~     Oil at a dose of 4 grams DHA + 0.8 grams EPA per day in the next phase. Participants will be~     randomized and blinded and will therefore no know what supplement they are taking in either~     phase.~   "
95465|NCT02317575|"~     This study evaluates four test formulations of a glucose lowering drug (LY900014)~     administered by injection under the skin of the abdomen. The study will be conducted in~     healthy people to investigate how the human body handles LY900014 and the effect of LY900014~     on blood sugar levels. Side effects and tolerability will be documented. The study will be~     conducted in two parts (Part A and Part B) to achieve its objectives. Each part of the study~     will last for about 11 to 12 weeks, including screening and follow up. Screening is required~     within 28 days prior to entering into either study Part A or Part B.~   "
95466|NCT02317562|"~     Primary objective:~      To assess the efficacy of I10E administered at a reduced maintenance dose in sustaining CIDP~     response after an initial 6-month treatment in PRISM study. (I10E-1302).~      Secondary objective:~      To assess the safety of I10E in this patient population.~   "
95467|NCT02317549|"~     Septic shock is a potentially life-threatening condition that can result in multi-organ~     dysfunction syndrome (MODS) and mortality. LB1148 was formulated to preserve gut integrity~     during physiological shock and ameliorate the subsequent autodigestion leading to MODS and~     mortality. The purpose of this study in septic shock patients is to determine if enteral~     administration of LB1148 will increase the number of days alive without cardiovascular,~     pulmonary or renal replacement therapy through Day 28.~   "
95468|NCT02317536|"~     This study evaluates two L-Carnitine-based products on muscle function in healthy older~     adults (55 to 70 years old). These products are suspected to improve muscle function and~     possibly promote building of muscle mass. One third of the subjects will be on Carnipure~     Product 1, one third will be on Carnipure Product 2 and one third will be on placebo.~   "
95469|NCT02317523|"~     This study evaluates the effectiveness of Behavioral Activation (BA) therapy vs Support and~     Information for reducing risk for emotional and cardiovascular diseases in Alzheimer's~     caregivers. Half of participants will receive BA and the other half will receive support and~     information.~   "
95470|NCT02317510|"~     The aim of this study was to compare general anesthesia (GA) and combined (epidural and~     spinal) anesthesia (CA) for laparoscopic cholecystectomy. General anesthesia is a gold~     standard for laparoscopic cholecystectomy(LC). The use of combined anesthesia may offer~     several advantages over general anesthesia.~      Fifty patients will be randomly assigned to either the CA LC (25 patients) or GA LC (25~     patients). All patients has symptomatic gall stone disease or polyp of gall bladder.~     Intraoperative events related to combined anesthesia , postoperative complications, pain~     score and duration of operation time will record.~   "
95471|NCT02317497|"~     Background: Sedation of the intensive care unit (ICU) patient is necessary to relieve the~     patient from pain, anxiety and agitation and to enable mechanical ventilation, diagnostic~     investigations and invasive procedures. While sedation policy has shifted from deep sedation~     to moderate, minimal, or even no sedation in the general ICU, optimal sedation of the~     cerebrovascular ICU patient is unclear and controversial.~      Method: MOderate vs DEep Regime in NeuroIntensive care SEdation (MODERNISE) is a prospective,~     randomized, open, two-center trial. Patients with acute ischemic stroke, intracerebral~     hemorrhage or subarachnoid hemorrhage who need to be ventilated are eligible for enrollment.~     It is intended to enroll 50 patients per group (n=100). Patients are randomized within 72h~     from admission to either moderate sedation as defined by Richmond Agitation Sedation Scale~     (RASS) >= -3 or to deep sedation as defined by RASS < -3 for the next 72h, after which~     weaning from sedation is aimed for in a stepwise fashion in both groups. If reduction of~     sedation is not feasible, patients remain at their respective sedation level for another 12~     hours, and sedation reduction is then tried again. Patients are multimodally monitored for~     systemic and cerebral parameters (the latter including bispectral index (BIS) monitoring).~     The primary endpoint is ICU length of stay (ICU-LOS); secondary endpoints are several~     pre-defined variables of the ICU course, feasibility of sedation levels without violation of~     pre-defined safety criteria, pre-defined complications, and short- and long-term functional~     outcome and mortality.~      Conclusion: The feasibility, safety and benefits of moderate as opposed to deep sedation even~     in the acute phase of severe cerebrovascular disease needs to be clarified in a prospective~     randomized study. Results from this study might change sedation regimes and help prevent~     unwanted effects of deep sedation in the brain-injured patient.~   "
95472|NCT02317484|"~     The purpose of this study is to evaluate clinical efficacy and safety of Sodium Glucose~     Co-transporter 2 (SGLT2) inhibitor, ipragliflozin, at doses of 50mg and 100mg, for Type II~     Diabetes under usual care. It is also to investigate and analyze the exploratory influential~     factor of ipragliflozin treatment on clinical efficacy and safety.~   "
95473|NCT02317471|"~     The purpose of this study is to evaluate the safety and effectiveness of autologous gp96~     treatment of gastric cancer.~   "
95475|NCT02317445|"~     Objective: To investigate the relationship between Helicobacter pylori (Hp) infection and the~     prognosis of acute coronary syndrome (ACS) in a Chinese population and to explore the~     significance of Hp eradication therapy in preventing major adverse cardiac events (MACE) and~     upper gastrointestinal bleeding (UGIB) in patients on dual antiplatelet treatment. Methods:~     To analyze 472 ACS patients with drug-eluting stent (DES) implantation from January 1, 2008~     to December 31, 2010 in the department of cardiology at Beijing Mentougou District Hospital.~     Patients were divided into three groups: Group 1, the Hp-negative patients (Hp-); Group 2,~     the Hp-positive patients with eradication therapy (Hp+ Therapy); and Group 3, the Hp-positive~     patients without eradication therapy (Hp+ No Therapy). All patients took 13C urea breath~     test, high sensitive C-reactive protein (hs-CRP)，homocysteine (HCY) and other biochemical~     indicators. The investigators explored the correlations of Hp eradication therapy with MACE~     (including recurrent myocardial infarction, revascularization and death) and UGIB after 3 to~     5 years of follow-up using survival analysis.~   "
95476|NCT02317432|"~     The primary intervention offered through this study is a manualized and culturally adapted~     CBT intervention combined with an exercise intervention, administered by trained Community~     Health Workers and exercise trainers to ethnic minority elders with moderate to severe mood~     symptoms and at risk of disability. In addition to the intervention implementation, the study~     examines how to successfully build collaborative research for the provision of evidence-based~     mental health and disability prevention treatments for ethnic minority elders in~     community-based settings. Thus, the study will evaluate the three components necessary for a~     successful intervention: efficacy, since the intervention must work, acceptability among~     clients and partnering agencies, and feasibility and sustainability within the organization.~   "
95477|NCT02317419|"~     This is a first-in-human, open-label, multi-center, Phase 1 study of RO6927005. The study~     will establish the safety and tolerability profile of RO6927005 and will be conducted in two~     parts.~      In Part A, the first dose escalations will be carried out using cohorts of 1 patient. Single~     patient cohorts will be used to investigate increasing doses until a first dose-limiting~     toxicity (DLT) is reached or until grade-2 related toxicity (except infusion-related~     reactions), whichever comes first. At least 3 patients will be enrolled in each cohort~     thereafter, which, if required, can be expanded with additional patients. Part B of the study~     will consist of a multiple ascending dose phase (multiple patients cohorts - >/= 3 patients)~     followed by an extension phase of RO6927005 given in combination with~     gemcitabine/nab-paclitaxel.~      Preliminary clinical activity will be explored throughout the study. Patients will be treated~     until disease progression and/or lack of clinical benefit, unacceptable toxicities,~     withdrawal from treatment for other reasons, death, pregnancy or termination of the study by~     the Sponsor, whichever comes first.~   "
95478|NCT02317406|"~     The purpose of this study is to evaluate the effect of the probiotic product on the GI tract~     flora composition.~   "
95479|NCT02317393|"~     The purpose of this study is to evaluate the contribution of the imaging to the expression of~     intégrines αvβ3 for the characterization of the residual masses of non-seminoma tumors at the~     end of chemotherapy.~      The investigators hope that the results of this first stage of the clinical trial come to~     consolidate the preclinical results obtained by the investigators team to characterizing the~     interest and the strong contribution of the use of a tracer resting on the expression of αvβ3~     integrine for the diagnosis of simple necrosed mass at the end of the treatment of a~     non-seminoma tumor, so allowing to defer a surgery to about 40 % of the patients.~   "
95480|NCT02317380|"~     Background:~      - Researchers want to learn about people s beliefs and values. They also want to learn about~     how people respond to information about cancer risk. They have created two short studies.~     They have combined these studies for convenience.~      Objective:~      - To learn about people s beliefs and values, and about how people respond to information~     about cancer risk.~      Eligibility:~      - Adults age 40-70 who are overweight, have never had cancer, and have an opposite-sex close~     relationship with someone in that age group who is also overweight.~      Design:~        -  This study will take place online or in a laboratory.~        -  Participants will take part in two studies. One is Values Study. The other is Cancer~          Risk Information.~        -  In Values Study, some participants will choose the most important value from a list.~          They will write about why that value is important to them. Others will choose the least~          important value from a list. They will write about why that value may be important to~          someone else.~        -  In Cancer Risk Information, participants will read a health message about a cancer risk~          relevant to themselves or to a close other. Some will wear special glasses that track~          their eye movements as they read.~        -  Participants will then answer questions about their beliefs about cancer risk and their~          intentions to lose weight.~        -  Both studies will take 30 minutes.~   "
95481|NCT02317367|"~     Background:~      - People respond differently when asked about their values. They also respond differently~     when they learn about how their actions affect their lives and health. Researchers want to~     learn more about these differences. This can help them improve public health messages.~      Objective:~      - To see how people respond differently to questions about their values and to information~     about alcohol and breast cancer.~      Eligibility:~      - Women age 18 and older who drink 7 or more alcoholic drinks per week.~      Design:~        -  This study will take place online.~        -  Participants will be randomly assigned to a group that will complete a certain task.~        -  Researchers will ask participants to complete 2 small studies:~        -  Values Study. Some participants may write briefly about a value that is important to~          them or to someone they are close to. Some participants will complete a short~          questionnaire instead of the writing exercise.~        -  Alcohol and Breast Cancer Study. Participants will read a health message. This will be~          about the link between alcohol use and increased breast cancer risk. Participants will~          then answer questions about what they read and their beliefs about alcohol and breast~          cancer.~        -  Both studies should take about 30 minutes.~   "
95529|NCT02316743|"~     The purpose of this study is to determine whether levothyroxine supplementation is beneficial~     in patients with systolic heart failure and subclinical hypothyroidism on the functional~     class evaluated with a 6 minute walk test.~   "
96665|NCT02301910|"~     The aim of the study is to determine if single-bolus recombinant nonimmunogenic~     staphylokinase is effective and save thrombolytic agent in patients presenting ST-segment~     elevation myocardial infarction in comparison to tenecteplase.~   "
95482|NCT02317354|"~     Background:~      -X-linked retinoschisis (XLRS) is an inherited eye condition. Researchers want to learn more~     about how people with XLRS choose to take part in research studies. They hope to find ways to~     help other people make decisions about joining early phase trials~      Objective:~      -To learn more about how people think and feel about taking part in early phase research.~      Eligibility:~      -Adults age 18 or older with diagnosed XLRS. They must be eligible to be screened for a Phase~     I/II ocular gene transfer clinical trial.~      Design:~        -  Participants will be screened for the XLRS gene transfer study. They will be~          interviewed:~        -  Eligible participants who join the study - before the gene transfer procedure, then 3~          months and 12 months after it.~        -  Eligible participants who do not join the study - after their screening visit and 3~          months and 12 months later.~      <TAB>- Participants who are screened but ineligible - after their screening visit.~      <TAB>- Participants who choose not to be screened - at the time they make the decision and 1~     year later.~        -  Interviews will ask for the participants thoughts about the clinical trial and why they~          chose to take part or not. The interviews will be recorded.~        -  On the day of interview 1, participants will fill out a survey about their mood and~          personality.~        -  On the days of interviews 2 and 3, participants will fill out a survey about their mood.~        -  Interviews may be done in person or by phone. Surveys can be done online or through the~          mail. Or they can be done in person at the NIH Clinical Center.~   "
95483|NCT02317341|"~     Background:~      - Fatigue is a common side effect of cancer and its treatment. No medications can treat this~     fatigue. Researchers want to see if the drug ketamine can improve fatigue after radiation~     therapy for cancer. They will compare the effects of ketamine on fatigue to midazolam, a~     sedative with similar effects.~      Objectives:~      - To better understand fatigue in people who completed radiation therapy for cancer. To look~     at the effects of a dose of ketamine on fatigue.~      Eligibility:~      - Adults 18 and older who completed radiation therapy for cancer and are enrolled in NIH~     protocol 08-NR-0132.~      Design:~        -  Participants will be screened with medical history, physical exam, and blood and urine~          tests. They will complete questionnaires about their fatigue and take a breath alcohol~          test.~        -  The study is divided into 2 phases:~        -  During the first phase I visit, participants will have blood taken. They will talk about~          their fatigue and other symptoms. They will take thinking and handgrip strength tests.~          Then they will get either ketamine or placebo (midazolam) through an intravenous line,~          placed by a needle guided by a thin plastic tube into an arm vein.~        -  Participants will have a follow-up phone call within 1 day.~        -  Participants will have phase I visits 3, 7, and 14 days after infusion. For the 3- and~          7-day visits, participants will take thinking and handgrip strength tests. They will~          complete questionnaires, talk about infusion side effects, and have blood taken. For the~          14-day visit, they will talk about their fatigue and infusion side effects. They will~          start phase II that day.~        -  Phase II visits are the same as phase I, except that the 14-day visit is over the phone.~   "
95484|NCT02317328|"~     Background:~      - By the time diseases of the retina are detected, serious damage has often already been~     done. Researchers want to find better ways of viewing the retina. One way called adaptive~     optics may help detect problems earlier.~      Objectives:~      - To study if adaptive optics can help find better ways to diagnose, treat, and manage~     retinal diseases.~      Eligibility:~        -  People over age 12 with an eye disease.~        -  Healthy volunteers over age 12 with 20/20 vision or better.~      Design:~        -  Participants will be screened with medical history and eye exams. These may include~          dilating pupils and taking pictures of the eyes.~        -  Participants will have 1 or more study visits. They will have:~        -  Medical and eye history.~        -  Questions about their medications.~        -  Eye exam including pupil dilation.~        -  Adaptive optics imaging. After dilation, participants sit still while looking into an~          adaptive optics instrument. They look at specific places and images are taken of their~          retina.~        -  They may also have:~        -  More images.~        -  Perimetry. Participants look into a lens and press a button when they see a light.~        -  Color vision tests.~        -  Electroretinogram. Participants will get numbing eye drops and special contact lenses. A~          small metal electrode will be put on their forehead. They will look at flashing lights~          and try not to blink.~   "
95485|NCT02317315|"~     Preterm delivery (PTD) is a leading cause of neonatal mortality and continues to be a major~     public health concern, reaching 12.9% in 2006, despite intense research to reverse this~     trend. Currently, fetal fibronectin (fFN) screening and cervical length determined by~     ultrasound are two tests which are proven to have benefit in the identification of those at~     greatest risk for preterm delivery. However the benefit of these tests is limited to~     situations where a negative result can avoid unnecessary interventions. Currently, maternal~     fetal monitoring is limited, as it is difficult to see what is going on in the placenta~     (maternal-fetal interface) without invasive measures such as placental biopsy or~     amniocentesis. Our goal for this study is to identify a group of biomarkers in non-invasive~     compartments (such as saliva, blood, urine, and/or cervical and vaginal secretions) that are~     associated with preterm labor and birth. We hypothesize that preterm labor will display an~     inflammatory profile, which consists of unique inflammatory biomarkers from different~     non-invasive bodily fluid compartments (such as Il-10 in urine, VEGF in cervical secretions,~     and IP-10 in saliva), that correlates with a high incidence of preterm birth.~   "
95486|NCT02317302|"~     In this study, 50 evaluable patients will undergo one FDG-PET study during their~     chemoradiation, in addition to the standard of care pretreatment and 3-month post-treatment~     clinical FDG-PET/CT or FDG-PET/MR scans. From all FDG-PET studies, tumor volume, SUVmax,~     FDGhetero, and texture maps will be obtained. Evaluating the changes in tumor SUVmax and~     heterogeneity during treatment will aid in better understanding the role of these biological~     parameters in inadequate response to chemoradiation. Other researchers, using MRI imaging,~     have evaluated changes in the cervical tumor volume during treatment. The investigators~     expect there will be variation in how cervical tumors shrink and change during chemoradiation~     and therefore we are going to use multiple measures in addition to tumor volume to evaluate~     cervical tumor metabolic heterogeneity. Being able to predict at diagnosis the patients who~     are at higher risk for persistent disease following chemoradiation would allow for future~     studies where these high risk patients could be specifically targeted with more aggressive~     therapy.~   "
95490|NCT02317250|"~     A substantial portion of people covered by Medicare will develop Alzheimer's disease and~     other forms of dementia that together devastate the lives of millions of people in the United~     States, and cost us a total of over $200 billion every year. Getting a brain scan with a PET~     scanner to look for abnormal brain metabolism patterns is recognized as reasonable and~     necessary for some patients with a recently established diagnosis of dementia (Centers for~     Medicare and Medicaid Services (CMS), Decision Memo CAG-00088R), but the evidence is~     considered less clear for patients having less severe cognitive problems, and/or for patients~     getting a brain scan with a PET scanner to look for abnormal proteins in the brain (CMS~     Decision Memo CAG-00431N). This project employs a scientifically rigorous design~     (prospective, multi-centered, randomized controlled trial) to determine whether such PET~     scanning can help distinguish more accurately than is being done in current clinical practice~     those patients with early molecular changes in their brains who will benefit from Alzheimer~     related treatments from those patients who will not, as proven by measuring to what extent~     the PET scans actually lead to earlier appropriate therapy, and in fact result in improved~     outcomes for Medicare beneficiaries and for the health care system in which they obtain care.~   "
95491|NCT02317237|"~     Patients suffering a stroke with a large vessel occlusion is often treated intra veneous~     thrombolyse and on top of that also intra arterial therapy. It is unknown what form of~     anaestesia is best during intra arterial therapy. The investigators will randomize these~     patients between general anaestesia and local anaestesia. Outcome will be growth of the~     ischemic lesion as judged on an MRI scan.~   "
95492|NCT02317224|"~     Surgery plays an important role in the treatment of anterior mediastinum disease. The major~     surgical approaches include: cervical approach, mid-sternal approach, cervical combined~     mid-sternal approach and video-assisted thoracoscopic approach. The cervical approach is~     rarely adopted because of its restricted visual field. The cervical combined mid-sternal~     approach have a broader field of vision, given this advantage, the surgeon can remove the~     thymus and its surrounding fat tissue more thoroughly. But the trauma of this approach is~     much larger, and the postoperative complication is also a serious problem. The video-assisted~     thoracoscope is often adopted by left or right approach, this minimally invasive procedure~     can not remove anterior mediastinum fat thoroughly. In clinical practice, the investigators~     designed a new method named 3-Hole subxiphoid approach. This study is designed to compare~     the safety and validity between this new method and others.~   "
95493|NCT02317211|"~     Anthocyanins, the water-soluble compounds that make plants appear different colors, have been~     shown to prevent insulin resistance, reduce the blood glucose and oxidative stress in~     rodents. The purpose of our study is to evaluate a potential protective effect of purified~     anthocyanins supplement on type 2 diabetes mellitus patients.~   "
95494|NCT02317198|"~     A randomized controlled, open label, multicenter trial with 1000 patients aged 70 years and~     older, presenting with Non-ST-elevation acute coronary syndrome. Patients will be randomized~     to either clopidogrel or the novel P2Y12 inhibitor (ticagrelor or prasugrel). Patients will~     be followed for one year for outcomes such as bleeding episode requiring medical intervention~     and net clinical benefit (all cause mortality, non-fatal myocardial infarction, non-fatal~     stroke, PLATO major and minor bleeding).~   "
95495|NCT02317185|"~     The overall goal of this clinical study is to characterize the fusion rate of geneX® ds bone~     graft substitute in comparison to autograft, which is considered the gold standard for~     posterolateral fusion. Assessments are made using AP and Lateral x-rays, F/E x-rays, and CT~     scans geneX® ds has been cleared by the FDA for use in these procedures; however this study~     will allow more detailed characterization of geneX® ds performance in the long-term (1 year).~     By using the patient as their own control, direct comparison to autograft can be performed~     while minimizing other variables.~   "
95496|NCT02317172|"~     Elderly people usually have systemic diseases and take medications that can cause dry mouth.~     The purpose of this study is to determine whether continuous use of edible, gel-based~     artificial saliva in geriatric population with dry mouth problems will reduce signs and~     symptoms of dry mouth and improve quality of patients' saliva.~   "
95497|NCT02317159|"~     This is a efficacy and safety study of imatinib Mesylate Capsule as First line treatment in~     patients with chronic phase of Chronic Myeloid Leukemia.~   "
95498|NCT02317146|"~     There are huge doubts as to how long to keep postpartum magnesium sulfate. Studies~     demonstrating the usefulness for 24, 12 or 6 hours are of little evidence and do not take~     into account the use of magnesium sulphate before delivery. Termination of pregnancy is the~     best option to prevent eclampsia and magnesium sulphate has proven effective, but do not know~     the minimum effective dose.The investigators believe that if the patient has received less~     than 8 continuous hours of magnesium sulphate before delivery, maintain magnesium sulfate for~     6 hours is as effective as keeping it for 24 hours.~   "
95499|NCT02317133|"~     The primary objective of this study is to search for evidence of quantitative or functional~     defects in plasma regulatory T cells (Tregs) in pediatric patients with Henoch Schönlein~     Purpura (HSP) as compared to a control population.~   "
95500|NCT02317120|"~     Primary objective To determine BRCA1 and BRCA2 variants in 250 Romanian women with~     breast/ovarian cancer selected for likeliness to harbor germline mutations in these genes by~     specific criteria for high-risk status including age at disease onset.~      Secondary objective Considering the fact that BRCA testing is not a routine procedure in~     Romania and mutation prevalence varies in different populations, we intend to look for the~     founder mutation in our population, running full BRCA genes sequencing to a representative~     population sample. This would allow a more targeted approach to real-life practice and would~     ensure personalized solutions for every patient in need.~   "
95530|NCT02316730|"~     24 healthy male volunteers are to be assigned to take orally Sanchi-Tongshu Capsule (Enteric~     coated pellets) and Sanchi-Tongshu Capsule in fasting condition according to a randomized,~     crossover, self-control method, with ginsenoside Rg1, ginsenoside Re and notoginsenoside R1~     as detection indicators. Establish the blood drug concentration-time  curve, compare the~     bioequivalence of the main effective ingredients of the two preparations during the~     absorption process in human.~   "
95531|NCT02316717|"~     This study will evaluate the safety and preliminary efficacy of two dose levels of IMM-124E~     in reducing liver fat and/or serum alanine aminotransaminase (ALT) compared with placebo.~   "
95501|NCT02317107|"~     Previous research and position statements have outlined the necessity of balance and gait~     testing in the post-concussion evaluation of athletes. However, many of the currently~     available balance testing techniques lack objectivity and sensitivity to the effects of~     concussion. Such balance impairments may exist following concussion due to disruption of~     vestibular and/or ocular motor systems. However, no clinically feasible tools have been~     longitudinally examined to detect gait balance control deficits or to investigate how~     vestibular or motor dysfunction may lead to gait imbalance. Additionally, participation in~     physical and cognitive activities post-concussion may affect recovery. While limited evidence~     exists to support this notion, further investigation is necessary to improve clinical~     management recommendations.~      The proposed study will allow for the examination of tools which add value to post-concussion~     clinical evaluations and study-related outcomes will enhance the understanding of dynamic~     balance control and vestibular/ocular motor recovery, and their potential for implementation~     into concussion management protocols.~   "
95502|NCT02317094|"~     This study evaluates the effects of a low-intensity blood-flow restricted exerciser protocol~     on patient reported physical function, in patients with sporadic inclusion body myositis. The~     study is designed as a parallel group randomized controlled trial with a treatment group and~     a control group.~   "
95503|NCT02317081|"~     Prospective, multicenter, single arm study, to assess the feasibility and safety of the~     Axetis Inert Stent for treatment of patients with de novo coronary artery stenosis in native~     vessels.~   "
95504|NCT02317068|"~     This study aims to determine whether increasing atrial base rate pacing to achieve at least~     75-80% atrial pacing in patients with sick sinus syndrome undergoing the implementation of~     dual-chamber pacemaker can be useful to prevent or decrease the atrial fibrillation during 6~     months follow-up duration.~   "
95505|NCT02317055|"~     The purpose of this study is to measure the tissular oxygen saturation in brain by magnetic~     resonance imaging on subjects and to correlate the results with near infrared spectroscopy~     measurements.~   "
95506|NCT02317042|"~     This study is to evaluate the efficacy of a new therapy (Automatic Expiratory Positive Airway~     Pressure with intelligent Volume Assured Pressure Support (AutoEPAP iVAPS)) designed to treat~     respiratory insufficiency, respiratory failure and/or nocturnal hypoventilation with upper~     airway obstruction. The study will be performed in two phases: In a sleep unit and in the~     home environment. The new therapy will be compared against two existing ventilator therapies:~     Spontaneous Timed (ST) mode and Intelligent Volume Assured Pressure Support (iVAPS).~   "
95507|NCT02317029|"~     Background:~      Cardiac arrhythmias can be terminated by electrical current applied by an external~     defibrillator. This treatment, named cardioversion, has been used for decades in the~     treatment of atrial fibrillation.~      Several kinds of defibrillators exist, though the relative efficacy and safety of these~     defibrillators is not clear.~      During cardioversion, oxygen is being administered, and it has been a long-held belief that~     oxygen is always beneficial for the patient. This is now being challenged by recent studies~     suggesting excessive oxygenation to be potentially dangerous for the patients.~      Objective:~        1. To compare the efficiency and safety of two different defibrillators~        2. To investigate the effects of excessive oxygen on injury of the heart following~          cardioversion.~      Experimental design:~      Patients will be recruited at the outpatient clinic at the Department of Cardiology, Regional~     Hospital of Randers, Denmark as a part of the pre-cardioversion check.~      Patients will be randomized to cardioversion using one of two defibrillators and randomized~     to treatment with room air or 100% oxygen.~      The cardiac condition will be measured by blood samples before cardioversion, 4 hours after~     cardioversion and 3 months after cardioversion. Heart rhythm will be measured by ECG before~     cardioversion, 1 minute-, 30 minutes- and 4 hours after cardioversion.~   "
95508|NCT02317016|"~     This is a Phase I, open-label, 2-part study in patients with a confirmed diagnosis of~     epidermal growth factor receptor (EGFR) mutation positive (EGFRm+) non-small cell lung cancer~     (NSCLC), who have progressed following prior therapy with an approved EGFR tyrosine kinase~     inhibitor (TKI) agent.~      Part A will assess the effect of AZD9291 on the pharmacokinetic (PK) parameters of~     rosuvastatin, following multiple oral dosing of AZD9291 in the fasted state.~      Part B will allow patients further access to AZD9291 after the PK phase (Part A) and will~     provide for additional safety data collection. All patients from Part A who completed~     treatment may continue to receive AZD9291 80 mg once daily as a single agent until: disease~     progression; they are no longer deriving clinical benefit; or any other reason.~   "
95509|NCT02317003|"~     This study evaluates the efficacy, in terms of energy expenditure, physical activity level,~     quality of life, blood pressure, waist circumference and weight, of a general practice based~     intervention involving a personalised physical exercise medical prescription, the structured~     delivery of information on the benefits of physical activity, a pedometer, and a pedometer~     log book, in 35 to 74 year old patients with cardiovascular risks factors.~   "
95510|NCT02316990|"~     Stress ulcers or stress-related mucosal disease (SRMD) is defined as acute superficial~     inflammation lesions of the gastric mucosa induced when an individual is subject to~     abnormally elevated physiologic demands.[1] Studies have shown that SRMD occurred in~     75%-100% ICU patients[1]. Gastrointestinal bleeding due to SRMD is an important complication~     in critically ill patients. The frequency of clinically important bleeding ranged from 5.3%~     to 33%.[2] The mortality in ICU patients with stress related bleeding approaches 50%, which~     is much higher than the patients without bleeding (9%). [3] In 1999, the American Society of~     Health-System Pharmacists (ASHP) published guidelines on the use of stress ulcer prophylaxis~     in medical, surgical, respiratory, and pediatric ICU patients [2]. PPIs and H2RA are widely~     used in China current clinical practice for the prevention of stress ulcer bleeding. However,~     there is no epidemiology data to show the risk factors for stress ulcer bleeding and the~     bleeding rate of Chinese neurosurgical critically ill patients who are usually suffering from~     brain trauma, cerebral haemorrhage or brain tumour operation. Information is needed to know~     about the characteristics in Chinese critically ill neurosurgical patients.~      Objectives of this Non-Interventional Study Primary~        1. Primary objective: To estimate the overall incidence of upper gastrointestinal (GI)~          bleeding in critically ill neurosurgical patients in China.~        2. Main secondary objective~             -  To estimate the incidence of upper GI bleeding with clinically significant~               complications in critically ill neurosurgical patients in China.~             -  To estimate the incidence of any overt upper GI bleeding without clinically~               significant complications in critically ill neurosurgical patients in China.~             -  To assess time to upper GI bleeding after a cerebral lesion.~             -  To investigate potential risk factors associated with upper GI bleeding, and assess~               how common certain risk factors occurred in upper GI bleeding patients.~             -  To assess the overall incidence of upper GI bleeding in critically ill patients by~               different risk factors for upper GI bleeding.~             -  To investigate the drugs, the route of administration, the doses and the duration~               commonly used for stress ulcer prophylaxis.~             -  To investigate the proportion of ICU patients with nasogastric tube, and the~               duration of nasogastric tube.~      (ICU: Intensive care unit PPIs: Proton pump inhibitors H2RA: H2 receptor antagonist)~   "
96666|NCT02301897|"~     The primary objective of this study is to determine the safety and efficacy of two oral doses~     of Proellex administered for up to 2 courses of treatment (18 weeks each), each separated by~     an Off-Drug Interval (ODI), to premenopausal women with symptomatic uterine fibroids.~   "
95511|NCT02316977|"~     The aim of the study is to establish the intrarater-reliability, criterion validity and~     responsiveness of the ADL-Questionnaire applied on an eHealth platform to be used by patients~     diagnosed with rheumatoid arthritis.~      The study is designed as a repeated test-retest study including 240 patients filling in the~     ADL-Q, HAQ-DI and PDQ at day 1, 3, 56 and 58. The study provides an eHealth platform (a~     home-module in the DANBIO database) which makes it possible for the patients to complete~     their assessments and send information from their own home.~      Intrarater reliability will be assessed by calculating the intraclass correlation~     coefficients (ICCs). Criterion validity will be evaluated based on correlational analysis and~     responsiveness based on effect sizes, in both cases involving HAQ-DI. PDQ scores will be used~     to classify participants based on pain phenotype to explore any relationship between pain~     phenotype and reliability.~   "
95512|NCT02316964|"~     This pilot trial studies decitabine, donor natural killer cells, and aldesleukin in treating~     patients with acute myeloid leukemia that has come back after previous treatment (relapsed)~     or has not responded to previous treatment (refractory). Drugs used in chemotherapy, such as~     decitabine, work in different ways to stop the growth of cancer cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Giving donor~     natural killer cells after decitabine may boost the patient's immune system by helping it see~     the remaining cancer cells as not belonging in the patient's body and causing it to destroy~     them (called graft-versus-tumor effect). Aldesleukin may stimulate natural killer cells to~     kill acute myeloid leukemia cells. Giving decitabine, donor natural killer cells, and~     aldesleukin may be a better treatment for acute myeloid leukemia.~   "
95513|NCT02316951|"~     This pilot study will seek to use emotion recognition technology from video to link patient~     facial expressions, heart rate and respiratory rate changes, and movement patterns to patient~     pain scores.~   "
95514|NCT02316938|"~     CRAD001AAU13 is a substudy of CRAD001A2433. The core study CRAD001A2433 is a 2-year,~     randomized, multicenter, open-label, 2-arm study evaluating graft function with everolimus~     and reduced CNI versus MPA and standard CNI in adult de novo renal transplant recipients.~     Patients in this study may use cyclosporine or tacrolimus as the CNI.~   "
95515|NCT02316925|"~     A randomized, double blind placebo-controlled parallel intervention in adults over the age of~     50 will be performed. Participants will receive a supplement capsule containing placebo~     (Crystalline Cellulose) or 500mg of Setria® Glutathione to eat for 120 days. Glutathione is~     hypothesized to replenish the body's reserves that may be depleted through natural aging~     process, poor diet, or due to the detoxification process for drugs. The primary end point is~     the number of healthy days experienced during cold and flu season. Secondary endpoints~     include cellular and biochemical measures from blood samples taken before and after the~     study.~   "
95516|NCT02316912|"~     First in man evaluation of single and multiple doses of compound ATX2417 in healthy male~     volunteers. A double blind placebo controlled parallel group ascending dose design; up to~     five dose levels for the single dose and up to two dose levels for the multiple dose (8 days~     of dosing). Subjects will be screened to assure normal health prior to inclusion in the trial~     and will be monitored for safety (adverse events, vital signs, ECGs, safety labs) and~     pharmacokinetic profile. A fasted/fed comparison will also be included in the single~     ascending dose part of the trial.~   "
95517|NCT02316899|"~     The objective of this study is to evaluate the efficacy and safety of ASP0456 in patients~     with constipation predominant irritable bowel syndrome (IBS-C).~   "
95518|NCT02316886|"~     The purpose of this study is to determine whether preventive coronary intervention on~     functionally insignificant coronary stenosis with vulnerable plaque characteristics plus~     optimal medical therapy reduces the incidence of the composite of cardiovascular death,~     target vessel myocardial infarction, or ischemia driven target lesion revascularization~     compared with optimal medical therapy alone.~   "
95519|NCT02316873|"~     The purpose of this study is to determine whether music training is an effective treatment of~     reading disorders~   "
95520|NCT02316860|"~     In the present study the investigators evaluate the sensitivity and specificity of passive~     tilt test in athletes, as well as their haemodynamic responses and autonomic nervous system~     activity during head-up tilt. Moreover, the investigators try to apply a novel algorithm for~     the improvement of diagnostic yield of tilt test in athletes.~   "
95521|NCT02316847|"~     This study will assess long-term safety and tolerability of repeat dose diazepam nasal spray~     in adolescents and adults with cluster seizures, with a focus on potential local effects~     (changes in nasal mucosa, olfaction, and taste).~   "
95522|NCT02316834|"~     The goal of this clinical research study is to learn about the effects of BMN 673 on ovarian,~     Fallopian tube, and peritoneal cancer. Researchers want to find out if certain~     characteristics of the DNA (the genetic material in cells) affect how the disease responds to~     therapy with BMN 673 and if treatment with BMN 673 affects the genetic material in cancer~     cells.~   "
95523|NCT02316821|"~     The purpose of this study is to assess the safety and efficacy of RTA 402 in chronic kidney~     disease (CKD) patients with type 2 diabetes in a double-blind, placebo-controlled study when~     this compound is administered once daily for 16 weeks in an intrapatient dose escalation~     design.~   "
95524|NCT02316808|"~     Efficacy of plant stanols as esters on LDL-cholesterol reduction is well documented.~     LDL-cholesterol lowering efficacy of the ingredient administered in a smoothie is less well~     known.~   "
95525|NCT02316795|"~     The NIR light source of our device is based on light-emitting diodes (LEDs), which can~     deliver sufficient light to biological tissues and induce fluorescence emission to meet the~     needs of the planned clinical studies. It should be noted that the light source is still well~     under the US FDA recommended limit for NIR exposure and ANSI standard. In addition, the light~     source is not laser-based, which is significantly safer than other optical imaging systems~     utilizing laser technologies. The fluorescence signals will be received by the detector~     portion of our device. Gain-settings could be easily adjusted during operation to optimize~     the contrast between high fluorescence areas (tumors) and low fluorescence areas (normal~     tissues). Real-time fluorescence video will be displayed in the goggle eyepiece as well as on~     a secondary monitor to facilitate viewing by other surgeons in the room.~   "
95532|NCT02316704|"~     The primary objective of this project is to investigate, using RSA, acetabular implant~     migration of the OsseoTi™ G7 acetabular cup in comparison to conventional PPS coated G7~     acetabular cup, and compare liner wear of thinnest available E1™ liner, allowing for the~     largest possible femoral head (36mm-44mm) to E1™ liner holding a 32mm femoral head in the G7~     acetabular system with endpoint assessment being performed at the 2 year follow-up.~   "
95533|NCT02316691|"~     Thyroid eye disease (TED) is an autoimmune inflammation of the orbital tissues that develops~     in up to 50% of patients with Graves' disease. Although about 80% respond to IVGC initially,~     the relapse rate is high and about 75% require further surgery despite initial response.~     Although the natural history of TED is associated with spontaneous remissions after about 1~     to 3 years, many irreversible serious ophthalmic and orbital complications can arise during~     this time. Therefore, there is a need for improved intervention strategies in the early~     active inflammatory phase of TED, to avoid progression to the cicatricial stage where disease~     manifestations can only be addressed in a rehabilitative fashion. The primary~     immunopathogenesis of Graves' disease is considered to be activation of B cells that then~     produce autoantibody against thyrotropin receptors in the thyroid (TRAb). Like in many~     autoimmune diseases, the inflammatory CD4+ T cell subset known as Th17 cells is also~     increased in blood of patients with active Graves' disease; the putative Th17 cytokine,~     IL-17, is also increased in serum and tears of TED patients. There is also an emerging~     pathogenic role for Th17 cells that co-express the chemokine receptor CXCR5 and drive~     autoantibody production. The contribution of Th17 cells to TED is not well defined. This~     study is an observational, longitudinal, prospective study of patients receiving treatment~     for thyroid eye disease.~   "
95534|NCT02316678|"~     The investigators will test the hypothesis that that greater efficacy of anti-tumor necrosis~     factor (antiTNF) therapy results in reduced need for bowel resection surgery, fewer serious~     infections, and reduced short term mortality risks, and therefore has a more favorable~     benefit to harm profile than corticosteroids for inflammatory bowel disease.~   "
95535|NCT02316665|"~     Hypothesis: To address the role of continuous positive airway pressure (CPAP)on nocturnal~     glycemia in patients having type 1 diabetes and sleep apnea syndrome.~      Investigators make the hypothesis that sleep apnea syndrome impacts nocturnal glycemia in~     type 1 diabetic patients and that continuous positive airway pressure treatment will permit~     to improve the nocturnal glycemic profile.~      Study design: Adult patients with type 1 diabetes will be recruited for an extensive study of~     sleep habits and assessment of sleep breathing disorders. When patients will present with~     severe sleep apnea syndrome (apnea-hypopnea index above 30 events/hour) and insufficient~     glycemic control (HbA1c > 7.5%), they will be randomized in continuous positive airway~     pressure treatment or sham-continuous positive airway pressure treatment group for three~     months.~      Main outcome: Nocturnal glycemic control will be assessed for 5 days before and after three~     months of the allocated treatment.~   "
95536|NCT02316652|"~     The purpose of this study is to determine whether the adjunctive use of chemical pocket~     disinfection with scaling and root planing is more effective than scaling and root planing~     alone in clinically reducing periodontal probing depth (PD), reducing bleeding on probing~     (BOP), and gaining clinical attachment level (CAL). It also will assess whether chemical~     pocket disinfection with scaling and root planing will have an effect on biomarkers of~     inflammation, as indicated by presence of pro- and anti-inflammatory cytokines, compared to~     scaling and root planing alone. The chemical pocket disinfection therapy consists of~     delivering a sodium hypochlorite solution followed by a neutralizing citric acid solution to~     the test site.~   "
95537|NCT02316639|"~     Recently, there has been a dramatic rise in the number of children participating in~     competitive sports. Adolescents involved in sports that require cutting, pivoting or body~     contact are at greatest risk for sustaining an anterior cruciate ligament (ACL) rupture of~     the knee, however, appropriate management remains controversial. The surgical technique is~     commonly performed in the adult population has been associated with risks for growth~     disturbance when performed on skeletally immature individuals. Therefore, the recommended~     standard of care in children is to initially follow a non-surgical management protocol that~     allows a patient to skeletally mature prior to ultimately receiving surgical reconstruction.~     Unfortunately, current non-surgical management protocols are ineffective at enhancing knee~     joint stability and dynamic function. There has been no research to indicate the most~     appropriate exercise program for the ACL deficient skeletally immature individual. A~     neuromuscular exercise program proven to be safe and effective in the ACL deficient adult~     population is perturbation training. In adolescents, research suggests neuromuscular~     exercises can reduce the rate of ACL injuries by 50%. However, currently there is no research~     investigating the benefits of a neuromuscular exercise on the management of a skeletally~     immature ACL-deficient individual. The results of this investigation will provide researchers~     and clinicians valuable information on the effect of neuromuscular perturbation exercises on~     knee joint stability and function immediately following injury. This has the potential to~     minimize the development of secondary meniscal tears and premature joint degeneration~     commonly demonstrated following an ACL injury.~   "
95538|NCT02316626|"~     It is well known that implantation of the developing blastocyst occurs during the luteal~     phase of the menstrual cycle when the endometrium is under the direct influence of~     Progesterone (P).Several prospective randomized controlled trials have evaluated the benefits~     of luteal phase P support in ovulation induction cycles and a recent review and meta-analysis~     demonstrated that it may be of benefit to patients undergoing ovulation induction with~     gonadotropins in intrauterine insemination (IUI) cycles. Until now, injectable P was offered~     only in an oil-base solution owing to the insoluble properties of the molecule, which made~     the IM route mandatory. A recent publication, however, demonstrated the efficacy of a new P~     formulation that could be a game changer. The aim of the present pilot trial will be to~     compare the efficacy and tolerability of 25 mg/d of the new SC P with 90 mg/d of vaginal gel~     P for luteal phase support (LPS) in COH and IUI cycles.~   "
95539|NCT02316613|"~     This French national, multicenter, prospective, longitudinal, observational study will~     describe the treatment modalities of a cohort of patients with relapsed or refractory~     follicular non-Hodgkin's lymphoma, with evaluation of the cohort overall and according to the~     presence or not of MabThera® (rituximab) maintenance therapy. Actively participating~     physicians will enroll patients and collect therapeutic management data in a real-life~     setting up to 5 years.~   "
95540|NCT02316600|"~     The investigators aim is to evaluate an instrument for supporting physical activity and~     monitors multiple parameters of frailty (a pre-disability condition) in frail elderly~     persons. The investigators are therefore developing a smart shoe insole to monitor key~     parameters of frailty during subject daily life and to promote walking. Our primary aim is to~     assess the acceptability of the solution for the follow up and the motivational coaching of~     frail patients at home. Results from this study will also be used to elaborate the design of~     a further larger national multicenter randomized control trial assessing the efficacy of the~     solution to prevent disability.~   "
95541|NCT02316587|"~     This observational cohort study studies the impact myocardial fibrosis has on patients with~     severe aortic stenosis undergoing aortic valve replacement.~   "
95542|NCT02316574|"~     Cognitive Behavioral Coping Skills Therapy (CBCST) is a commonly utilized, evidence-based~     psychosocial therapy (talk therapy) for alcohol dependence. By identifying the neural~     mechanisms through which CBCST changes drinking behavior, it may be possible to improve its~     efficacy. CBCST promotes abstinence by teaching coping skills for managing alcohol-related~     thoughts and emotions. In this pilot study, the investigators examine the neural systems that~     play a role in the learning of coping skills through CBCST, specifically focusing on the role~     of emotion regulation systems.~   "
95543|NCT02316561|"~     The purpose of the study is to investigate the feasibility of a preoperative, single dose,~     ablative partial breast radiation treatment in patients with early-stage breast cancer.~   "
95544|NCT02316548|"~     This randomized phase II trial studies the side effects and how well postoperative intensity~     modulated radiotherapy works after surgery in treating patients with urothelial bladder~     cancer. Radiation therapy uses high energy x-rays to kill tumor cells left behind in the~     pelvis after surgery. It is not yet known whether surgery followed by radiotherapy is more~     effective than surgery alone in treating patients with urothelial bladder cancer.~   "
95545|NCT02316535|"~     Approximately half of colorectal cancer (CRC) patients were first diagnosed after 70 years~     old. However, compared with younger patients, elderly patients were often undertreated in~     chemotherapy due to their impaired tolerance. Recently, there have been great controversy on~     adjuvant chemotherapy strategy for stage II/III CRC patients. As an oral fluoropyrimidine,~     capecitabine has been demonstrated to be equivalent to i.v. 5-Fu/leucovorin regimen in stage~     III CRC patients. In light of fewer adverse effects and better flexibility, capecitabine was~     regarded as an ideal alternative for elderly CRC patients, but the optimal dosage for stage~     II/III elderly CRC patients still remains inconclusive. Our trial expected to prospectively~     randomized 710 postoperative stage II/III elderly CRC patients (between 70 and 90 years of~     age) to adjuvant mono-chemotherapy with a standard dose of capecitabine (2500 mg/m2/day) or a~     reduced dose (2000 mg/m2/day). This is a non-inferiority phase 3 trial with a primary~     endpoint of 3-year disease free survival (DFS), and other outcomes include 3-year overall~     survival(OS), completion rate, toxic and adverse effects and quality of life(Qol). By this~     trial, we aimed to achieve more precise evidence on the individualized adjuvant chemotherapy~     strategy for stage II/III elderly CRC patients.~   "
95546|NCT02316522|"~     The main objective is to study the epigenetic contribution to the pathophysiology of diabetic~     nephropathy in Qatari population.~   "
95547|NCT02316509|"~     This is an open-label, dose-finding, safety, pharmacokinetics (PK), and evidence-of-activity~     study of GDC-0927 in postmenopausal women with locally advanced or metastatic Estrogen~     Receptor Positive (ER+) Human Epidermal Growth Factor Receptor 2 (HER2) breast cancer. The~     study will be conducted in two parts: Dose escalation and Dose expansion. During dose~     escalation, GDC-0927 will be administered orally as a single dose on Day -7 for PK evaluation~     during the lead-in period. Depending on safety and tolerability, participants will be~     assigned sequentially to escalating doses of GDC-0927 using standard 3+3 design. During dose~     expansion, there will be no PK week lead-in period. All participants will be treated until~     disease progression, unacceptable toxicity, participant withdrawal of consent or study~     termination.~   "
95548|NCT02316496|"~     The main objective of this study is to evaluate the objective response rate at two months~     (complete disappearance of the disease and partial disappearance of the disease) obtained~     after administration of combination therapy with cetuximab and irinotecan in the patients~     with metastatic colorectal cancer.~      Secondaries objectives will be assessed progression-free survival, overall survival,~     toxicity, quality of life.~   "
95549|NCT02316483|"~     To assess the hypothesis that Charcot foot is associated with more vascular complications~     compared to matched diabetic patients without Charcot foot and to classify patients with~     Charcot foot according to the human genetic classification of the Qatari population.~   "
95550|NCT02316470|"~     Phase 2, randomized, observer-blind, placebo-controlled, multi-centric study including 4~     parallel study groups.~      500 Subjects (thereof, 250 aged 50 - 64 years and 250 aged 65 years and older) will be~     randomized in a (3:3:3:1) ratio to receive either VLA84 75 µg w/o (without) Alum, VLA84 200~     µg w/o Alum, VLA84 200 µg w/ (with) Alum (150 subjects each), or placebo (50 subjects), as~     i.m. (intramuscular) vaccinations into alternating arms, on Days 0, 7 and 28~   "
95551|NCT02316457|"~     The Mutanome Engineered RNA Immuno-Therapy (MERIT) study introduces a novel concept for~     Individualized Cancer Immunotherapy (IVAC®) to treat each patient with the relevant and~     immunogenic RNA vaccines for a given patient's tumour. The TNBC-MERIT trial uses two~     complementary strategies, the IVAC® WAREHOUSE and the IVAC® MUTANOME concept, resulting in~     two custom-made IVAC® investigational medicinal products (IMPs) (IVAC_W_bre1_uID and~     IVAC_M_uID) for each individual patient.~   "
95552|NCT02316444|"~     The aim of this study is to compare the effectiveness of two vaccination strategies against~     Hepatitis B virus (HBV) in subjects already infected with human immunodeficiency virus (HIV).~      Researchers plan to determine the optimal vaccination strategy for achieving protective~     immunity to HBV infection in HIV-infected adults attending Mulago Hospital's HIV care clinic.~      Primary objectives are to assess:~        1. The role of CD4-cell count and HIV viral loads on the HBV vaccine response.~        2. The role of highly active antiretroviral therapy (HAART) on the HBV vaccine response.~      The secondary objective is to evaluate whether lack of HAART is associated with high rates of~     loss to follow-up.~   "
95554|NCT02316418|"~     The aim of the study is to provide evidence of safety and preliminary performance of the~     Hairstetics™ anchoring system in female subjects affected with androgenetic alopecia (female~     pattern hair loss; (FPHL)).~      The study will also help to determine whether the Hairstetics™ anchoring system, in~     conjunction with attachment of hair extensions, is efficacious in improving patient and~     physician aesthetic satisfaction with the treated scalp appearance in female patients with~     androgenetic alopecia.~   "
95555|NCT02316405|"~     It has been found that arm and leg cycling is similar to walking. Thus, the objective of this~     research is to determine if arm and leg cycling can be used to improve walking ability in a~     post-stroke population. This outcome would directly impact the health and quality of life for~     those who have suffered a stroke.~   "
95556|NCT02316392|"~     This study is a prospective, non-randomized, longitudinal, observational study that will~     recruit about 5 lung transplant patients per year for 3 years.~   "
95557|NCT02316379|"~     The goal of this study is to evaluate the usefulness of hyperpolarized (HP) 129Xe (xenon) gas~     MRI for regional assessment of lung function in a normal population of adults for the~     purposes of obtaining optimal images through MRI.~   "
95558|NCT02316366|"~     The purpose of this study is to determine if warming the intravenous (IV) fluid given to~     patients with Sickle Cell Disease who are experiencing painful episodes known as~     Vaso-Occlusive Episodes; will decrease rates of hospital admission, decrease amounts of IV~     pain medications given, improve pain and improve global comfort.~   "
95559|NCT02316353|"~     The aim of this study is to assess the long-term safety of C1-esterase inhibitor (C1-INH) in~     preventing hereditary angioedema (HAE) attacks when it is administered under the skin of~     subjects with HAE. The safety of participating subjects will be assessed for up to 54 weeks.~     The long-term efficacy of C1-INH will also be assessed. Each eligible subject will enter the~     treatment phase, wherein subjects will be randomized to treatment with either low- or~     medium-volume C1-INH. Subjects who have an insufficient treatment response during the study~     will be given an opportunity to undergo a dose increase. The study aims to enroll eligible~     subjects who completed study CSL830_3001 (NCT01912456). Subjects who did not participate in~     study CSL830_3001 may also participate, if eligible and if space permits. Subjects from the~     United States (US) who complete Treatment Period 2 will be allowed to participate in an~     Extension Period. During the Extension Period participating US subjects will continue to~     receive treatment with open-label CSL830 for up to an additional 88 weeks.~   "
95560|NCT02316340|"~     This will be a randomized phase II clinical trial of patients with histologic documentation~     of metastatic colorectal cancer, who have received local and currently approved standard~     therapies, excluding RGF.~   "
95561|NCT02316327|"~     RATIONALE: Classically the evaluation of response in lung cancer has been based in comparing~     pre & post treatment tumour volume by means of studying changes in the diameter of the~     selected target lesions by RECIST. The introduction of new targeted drugs creates the need of~     a different response assessment. Functional imaging techniques are able to study in vivo~     physiological processes of angiogenesis. Therefore, dynamic techniques may be more~     appropriate for assessing response to antiangiogenic drugs, whose mechanism of action is~     focused on tumor's vasculature normalization. Preliminary studies have demonstrated~     significant and very early changes in indirect vasculature parameters such as flow, blood~     volume and tumor perfusion with vascular-targeting agents. These techniques may be useful for~     selecting patients who are going to benefit from antiangiogenic therapy by an early~     evaluation of response by means of functional imaging method.~      PURPOSE: IMPACT is an open-label, single arm phase II/IV study to evaluate the predictive~     value and early radiologic response or perfusion computed tomography (CT) in patients~     diagnosed with unresectable advanced, metastatic or recurrent non-squamous NSCLC treated with~     bevacizumab in combination with chemotherapy.~   "
95562|NCT02316314|"~     Friedreich's ataxia (FRDA) is an autosomal recessive disease characterized by loss of~     coordination and cardiomyopathy. It is the most common form of inherited ataxia with an~     incidence in 1/50,000 in the Caucasian population. FRDA is associated with progressive damage~     to the nervous system, resulting in symptoms ranging from gait disturbance to speech~     problems, as well as diabetes and heart disease. The heart disease manifests as~     cardiomyopathy, and is responsible for approximately 60% of deaths from FRDA. This study is~     designed to characterize the cardiac manifestations of the disease using exercise, MRI, ECHO~     and serum parameters, in the context of the neurological disease.~   "
95563|NCT02316301|"~     The aim of this study was to determine whether misoprostol administered 12 hours before~     office hysteroscopy can relieve pain more effectively compared with misoprostol administered~     3 hours before office hysteroscopy.~   "
95564|NCT02316288|"~     Chronic pain is a costly public health problem that is associated with poor quality of life.~     Previous research has demonstrated extensive evidence showing that pain coping is not~     manifested by patients in isolation but within the context of significant relationships such~     as marriage. For instance, a partner may avoid or reject their partners' negative emotions~     about pain, provide unempathic responses to their partners' pain, or change their thoughts~     about pain. The patient's pain experience and the couples' relationship also have a cyclical~     relationship, in which both can affect each other and the overall quality of life for both~     partners. Currently, current clinical practice does not target both partners to alleviate~     pain. This is highly problematic given that a number of chronic pain patients—those with~     interpersonal distress—often do not complete, and thus, do not benefit fully from existing~     treatments. Even if treatment is completed, individuals may not maintain improvements if they~     return to distressed social environments that undermine individual coping efforts. Thus, it~     is clear that new interventions derived from integrative models of individual and dyadic~     coping are needed to alleviate pain and suffering in patients who are at risk for poor~     treatment outcomes. This research study aims to develop a novel psychological intervention~     aimed at couples in which one partner has chronic pain. Our central hypothesis is that a~     theoretically integrative intervention that improves both partners' psychological flexibility~     (i.e., acceptance, mindfulness, values-based action) and relational flexibility (i.e.,~     emotional disclosure, empathic responding) skills will be feasible and valid and that it will~     alleviate pain and improve quality of life. This is a departure from current practice, which~     focuses solely on the patient's individual functioning, does not address the spouse's~     psychological inflexibility, and does not address relationship issues.~   "
95565|NCT02316275|"~     To determine the impact of unrestricted postoperative activity on intermediate- and long-term~     continence outcomes of mid-urethral sling surgery in women with stress urinary incontinence.~      To assess the natural return to baseline activity level when patients are unrestricted~     following mid-urethral sling surgery with or without concomitant anterior or posterior pelvic~     organ prolapse repair.~   "
96746|NCT02300844|"~     This trial is conducted in the United States of America (USA). The aim of this trial is to~     investigate the safety, tolerability and pharmacokinetics of single doses of NNC0174-0833 in~     normal weight, overweight to obese but otherwise healthy male subjects.~   "
95566|NCT02316262|"~     Subjects are being asked to participate in this study because they have an arm or leg~     amputation and have developed pain related to a neuroma (an ongoing localized pain related to~     a cut nerve ending).~      The investigators are studying how targeted reinnervation (TR) helps to both treat neuroma~     pain and to have increased prosthetic control. This surgery connects these cut nerve endings~     to nerves going into nearby nonfunctional muscles. This surgery was developed to allow~     amputees to have better prosthesis control. By chance, neuroma pain improved significantly~     with TR. The investigators, therefore, are conducting this clinical trial. The investigators~     will ask all participants to fill out a questionnaire both before and after surgery. This~     will help us understand how a neuroma affects the quality of life of amputee will allow us to~     understand how to best improve neuroma pain and prosthesis control.~      In order to confirm the presence and location of the neuroma before surgery, a magnetic~     resonance image (MRI) will be performed. Taking these pictures requires subjects to lie still~     for a short period of time but does not involve any invasive procedures.~   "
95567|NCT02316249|"~     To compare the use of Estrace ® vaginal cream against a placebo vaginal cream in reducing~     symptomatic vaginal discharge and vaginal erosion in patients who are using the Gellhorn or~     Ring with support pessaries.~   "
95568|NCT02316236|"~     The study is to observe whether dexmedetomidine could reduce agitation during emergence from~     general anesthesia in patients undergoing retroperitoneal laparoscopic surgery.~   "
95569|NCT02316223|"~     A 3-arm, patient-randomized trial among Latino and African-American older adults with~     poorly-controlled asthma will be conducted to compare the effectiveness of clinic-based vs.~     home-based asthma care coordination / self-management support (CC/SMS) vs. usual care.~   "
95570|NCT02316210|"~     This study aims to facilitate further optimization of a neuromuscular electrical stimulation~     device for use in patients whom are suffering from oedema and neuropathy~   "
95571|NCT02316197|"~     MSC2490484A is an investigational drug that is being evaluated for the treatment of subjects~     with advanced solid tumors or chronic lymphocytic leukemia (CLL) that likely differs from~     other cancers in how it repairs damaged DNA (genetic material). This is a first-in-man Phase~     I study, which means that it is the first time the study drug is being used in humans. The~     main purpose is to determine the highest dose that does not cause unacceptable side effects.~     The second is to determine the appropriate dose to use in future research for subjects with~     cancer. Othergoals of the study are to learn about the drug's safety and side effects, how it~     affects the tumor, and how the body processes the drug.~   "
95572|NCT02316184|"~     Two types of brief intervention, Brief Advice (BA) and Motivational Interviewing (MI), have~     been shown to be efficacious in reducing drinking in non-HIV samples. Our goal is to~     determine whether offering counseling beyond Brief Advice, namely MI, has greater alcohol~     reduction effects. In the proposed randomized trial, all 300 HIV-HCV co-infected participants~     will receive BA delivered by their HIV PCP during a regular HIV visit and will then be~     randomized to either a 30-minute Motivational Interviewing Intervention with a Behavioral~     Counselor (MI) or to HIV clinic treatment-as-usual. After this initial meeting, drinking~     check-in (MI or BA) sessions will then be provided telephonically every three months for 18~     months, with a final assessment at 24 months. Our primary outcome is drinks per week.~   "
95573|NCT02316171|"~     The study will consist of 2 sequential parts. Part A is a study of the safety and~     tolerability of CAVATAK administered via intravesical instillation in patients with~     non-muscle invasive bladder cancer scheduled to undergo TUR. Part B will evaluate the safety~     and tolerability of CAVATAK administered in sequential combination with low dose Mitomycin C~     in the same patient population.~   "
95574|NCT02316158|"~     The overall aim with the project PsYoungSupport is to evaluate Internet and communication~     technology (ICT) health efforts, i.e. information, education and support for young adults~     (16-25 years) who are first degree relatives or represent the close social network (relative~     or close friend) of individuals with mental illness, with regard to the process (the quality~     and usefulness of the support) and the effect (on health and quality of life, situation as~     relative or part of close social network and consumption of other support/care) of the~     intervention.~      The participatory design is one of the foundations of this project, and young adult~     participants will be consulted through out the research project. PsYoungSupport is a research~     program comprising three phases, Phase I is a survey of young relatives' and close friends'~     needs for internet based information, education and support, Phase II is the development of a~     website, and Phase III is an intervention based on the previous phases. The aim of phase III~     is to evaluate the effect of an internet based intervention containing information, education~     and support for young adults in families where a family member suffers from mental illness or~     functional disability. The participants (N=400) will be randomised to two groups with~     different kinds of support. The participants will be evaluated using self-questionnaires and~     web interviews at the following occasions: baseline at the start of the intervention, after 4~     months and after 8 months. This project will have implications for persons suffering from~     mental illness as well as for their relatives and close friends.~   "
95575|NCT02316145|"~     Purpose: To develop a model for internet-based support and coaching to young adults with~     neuropsychiatric disorders (NPD). To improve the individual's psychosocial functioning and~     his/her understanding of how he/she is functioning.~      NPD comprise problems with social interaction, attention, impulse control and hyperactivity.~     The most common NPD diagnoses are ADHD (attention deficit hyperactivity disorder), autism~     spectrum condition (ASC) and Tourette's disorder (TD). In this study the investigators use~     Internet-based treatment for young adults with NPD.~      Method: Support/coaching by using communication over the Internet (chat and e-mail) with~     individuals with NPD. Twice every week during 8 weeks, young adults with NPD are offered~     support and coaching over the Internet by psychologist/educational therapist with great~     experience from NPD. The individuals are assessed before and after treatment pertaining to~     quality of life, sense of coherence, self-esteem, depressive and anxiety symptoms, and~     parents' evaluation of the young adult's situation.~   "
95795|NCT02313259|"~     The purpose of the study was (1) to determine thresholds for discriminating speed in~     peripheral fields of patients with dry AMD and (2) to examine the driving skills of licensed~     drivers with early dry AMD using a driving simulator and to investigate how their healthy~     counterparts perform on the same driving tasks. We hypothesized that speed discrimination may~     be better in patients with dry AMD than in healthy control subjects.~   "
95576|NCT02316132|"~     After standard endomicroscopy with fluorescein to investigate for dysplasia in Barrett's~     esophagus the endoscope will be forwarded into the 2nd part of the duodenum. Fluorescein is~     needed for CLE but is not part of the investigation.~      Initial CLE baseline images will be taken to assure intact mucosa and allow later detailed~     baseline counts of intraepithelial lymphocytes (IEL) and epithelial breaks in the duodenal~     mucosa.~      Thereafter, either 10 ml NaCl 0.9% or 100µg CRF topped up to 10ml with NaCL 0.9% (according~     to randomisation) will be injected intravenously. Endoscopist and assistant staff will be~     blinded to the randomisation. Subsequently, the gut surface will be examined for at least 5~     min with endomicroscopy for any change in IEL, epithelial breaks/gaps with extrusion of~     fluorescein into the gut lumen and widening of intervillous space.~      Post procedure mucosal fluid will be aspirated for assessment of mast cell tryptase and eosin~     catatonic protein (ECP), and 8 duodenal biopsies will be taken for 1) electron microscopy to~     visualise mast cell degranulation and 2) paraffin embedding for subsequent staining for mast~     cell tryptase to identify mast cell activation and numbers.~      The procedure will take around 15 minutes in addition to the routine investigation performed~     prior to the study. A study outline is presented in figure 1.~      Samples taken are the same amount as done in the previous food associated study.~   "
95577|NCT02316119|"~     Background: About 5% of patients with acute coronary syndrome (ACS) have had previously~     ischemic stroke (IS) or transitory ischemic attack (TIA). This is a high-risk population,~     with a high incidence of ischemic events, and also of bleeding events. While the high~     ischemic risk in this population is attributed to a higher prevalence of cardiovascular risk~     factors, their predisposition to bleeding events is not well understood. Hypothesis: The~     increased bleeding risk in ACS patients with history of cerebrovascular event may be~     justified by a low platelet activity. Methods: Unicentric, prospective, case-control study,~     which included approximately 100 post-ACS patients with history of IS/TIA previously to the~     acute coronary event (Case Group) and 100 patients without IS/TIA (Control group). The groups~     were matched for gender, age, and ACS type and year of occurrence. All patients were taking~     aspirin, and the main exclusion criteria were use of dual antiplatelet therapy, previous~     hemorrhagic stroke, severe renal dysfunction, thrombocytopenia or coagulopathy. Main~     analysis: Platelet aggregation was evaluated by 6 methods: VerifyNow Aspirin®, VerifyNow~     P2Y12®, PFA 100®, thrombelastography (ReoRox®), light transmission aggregometry with ADP (LTA~     ADP) and epinephrine (LTA EPI) as agonists. Additional analysis: genetic, HDL transport and~     inflammatory evaliation~   "
95578|NCT02316106|"~     The purpose of this study is to evaluate three daratumumab dose schedules in participants~     with Smoldering Multiple Myeloma.~   "
95579|NCT02316093|"~     Obesity may affect periodontal health by inducing gingival oxidative damage through increased~     production in circulating reactive oxygen species (ROS). Several studies have demonstrated~     that 8-OHdG in bodily fluids can act as a biomarker of oxidative DNA damage in periodontal~     diseases and for evaluating the effect of periodontal treatment. In the present study we~     hypothesized that high ROS levels in circulation may increase oxidative stress levels in the~     gingival crevicular fluid (GCF) and saliva in obese patients with periodontal disease, thus~     periodontal therapy could have positive effects on ROS levels.~   "
95580|NCT02316080|"~     The aim of this project is to evaluate in vitro and in vivo the effect of dental bleaching~     agents, carbamide peroxide 16% (T1) and hydrogen peroxide 35% (T2) together with~     desensitizers/remineralizer agents, Sensodyne® dentifrice (D1); experimental dentifrice with~     7,5% of Biosilicate micro-particles (D2); Odontis RX® dentifrice (D3); Sorriso® dentifrice~     (D4); Biosilicate micro-particles paste, 1:1 (D5), Desensebilize Nano P (D6), bioglass type~     45S5 paste, 1:1 (D7); GC= distilled water, in the experimental groups: T1/D1; T1/D2; T1/D3;~     T1/D4; T1/D5; T1/D6; T1/D7; T1/GC e T2/D1; T2/D2; T2/D3; T2/D4; T2/D5; T2/D6; T2/D7; T2/GC.~     In the in vitro study, microhardness and roughness measurements, and images using scanning~     electron microscopy (SEM) will be made on samples of bovine dental enamel and dentin~     (4x4x3mm; n=10 per group) before and after the treatment with the bleaching gels (T1= 14~     days/ 04 hours/day; T2=single session) and the desensitizers/remineralizer agents. In the~     clinical study, the volunteers (n=10 per group) will be evaluated regarding dentin~     hypersensitivity (DH), using visual analogue scale, before the beginning of the treatments~     (T1 and T2) and during the next 14 days (1º, 3º, 7º, 10 º e 14º days) in which the~     desensitizers/remineralizer agents (there´s no control group in the clinical experiments)~     will be applying. Data will be analysed intra and inter-group, statistically.~   "
95581|NCT02316067|"~     The purpose of this study was to evaluate the effects of an exercise program proposed by the~     CHORDATA® Method on the functionality, maximal isometric torque, muscle activity and muscle~     thickness of trunk muscles in patients with traumatic spinal cord injury.~      The hypothesis is that the CHORDATA® Method could reduce the deleterious effects of the~     traumatic spinal cord injury.~   "
95582|NCT02316054|"~     Long-term additive prognostic value of heterogeneity myocardial perfusion imaging of SPECT~     over clinical and ischemia in high-risk diabetic patients~   "
95583|NCT02316041|"~     This is a feasibility and clinical evaluation study of the VisuMax femtosecond laser for~     refractive correction of hyperopia using the small incision lenticule extraction (ReLEx~     smile) method.~      In ReLEx® the VisuMax femtosecond laser creates two interfaces that define a refractive~     lenticule of stromal tissue. In ReLEx® FLEx, the upper interface is converted into a LASIK~     flap by the creation of a sidecut. The LASIK flap is lifted and the lenticule can be removed~     to correct the refractive error by tissue subtraction. In ReLEx® smile, the lenticule is~     dissected and removed through a small 2-3mm incision without the need to create a whole flap.~      The aims are i) to optimize the VisuMax settings for lenticule separation ii) to optimize the~     lenticule geometry iii) to assess the safety, efficacy and stability of the treatment~   "
95745|NCT02313922|"~     The purpose of this study is to evaluate whether etanercept combined with methotrexate are~     superiority than etanercept as monotherapy in the treatment of chinese severe plaque~     psoriasis. A phase IV, multicenter, randomized, double-blind, controlled trial was~     conducted.The primary outcome was Change from baseline in plaque psoriasis as assessed by~     PASI (psoriasis area and severity index) response or PASI75 (a patient that has an~     improvement from baseline PASI of at least 75%)~   "
98927|NCT02272374|"~     The purpose of the study is to evaluate the clinical outcomes and cost-effectiveness of~     different vascular access(arteriovenous fistula, tunneled cuffed catheter and arteriovenous~     graft) in the elderly and very elderly with end-stage renal disease in China.~   "
95584|NCT02316028|"~     Despite the advances in the medical treatment of unresectable liver metastases from~     colorectal cancer there is currently no curative treatment option available for these~     patients. Decitabine is a cytidine analog with proven anti-neoplastic activity in patients~     with acute myeloid leukemia and myelodysplastic syndromes. Decitabine causes demethylation of~     the DNA strands of replicating cells. Hereby decitabine treatment demethylates the promoter~     regions of tumor suppressor- and cancer testis antigen encoding genes leading to expression~     of these genes by the cancer cells. The hepatic arterial route for administration of~     cytotoxic drugs has been widely explored in treatment of colorectal cancer liver metastases~     because these metastases depend for their blood flow from this artery (as opposed to the~     normal liver tissue that is mainly dependent from the portal vein). By investigating the~     administration of decitabine by hepatic arterial infusion the investigators intend to explore~     the potential advantage of minimizing the systemic exposure (and toxicity) and maximizing the~     concentration of decitabine within the liver metastasis. The primary objective of this phase~     I will be to establish the recommended dose for decitabine by HAI for further use in phase II~     trials. The most important secondary objective will be to document the effect of decitabine~     by HAI on the expression of cancer testis antigens by the colorectal cancer cells, serving as~     a reference for potential further exploration of decitabine by HAI in combination with cancer~     immunotherapy~   "
95585|NCT02316015|"~     The aim of this study is to investigate if a standardized nutritional intervention with a~     protein and energy enriched milk could help overcome the catabolic state in children~     hospitalized with a bronchiolitis and thus creating a better nutritional state during~     hospitalization and at outpatient follow-up.~      The investigators also want to assess the clinical repercussion on the number of~     hospitalization days, the duration of oxygen support and the quality of life at ouptatient~     follow-up.~   "
95586|NCT02316002|"~     The main purpose of this study is to see how well the experimental drug pembrolizumab~     (MK-3475) works in people with oligometastatic NSCLC who have already had treatment for their~     disease. All patients will receive 200 mg of pembrolizumab intravenously on Day 1 of each~     21-day cycle. Patients will receive the study drug for up to 8 cycles, and then if their~     disease is doing well and the study doctor thinks they will benefit patients may receive~     pembrolizumab for up to 8 more cycles.~   "
95587|NCT02315989|"~     The main purpose of this study is to collect the safety data of Sumitomo Heavy Industries'~     proton therapy equipment for the treatment of solid cancer patients in Linkou Chang Gung~     Memorial Hospital, including the patients' early-stage adverse reactions and the efficacy on~     tumors, as well as to assess the operating functionality of the proton therapy system.~   "
95588|NCT02315976|"~     This is an open, self-paired study of 200 patients with heart failure who have a diagnosis of~     chronic stable angina pectoris, who will be treated for 30 days with propatyl nitrate (10mg)~     . Treatment regimen is 3 sublingual tablets per day, at 8:00 AM, 2:00 PM, and 8:00 PM. The~     study will include three visits the patient to the study center: Pretreatment / Assessment 1,~     Assessment 2 after 15 days of treatment, and the Assessment 3 after 30 days of treatment. At~     each visit, data will be collected on the medical history, physical examination and vital~     signs, and evaluation of episodes of angina pectoris, as well as the laboratory evaluation of~     adverse events and the use of concomitant medications.~   "
95589|NCT02315963|"~     High motivation is a predictor for good therapy results in physical therapy [Grahn 2000]. The~     investigator want to show that it is possible to increase patients motivation for stroke~     rehabilitation by providing them objective performance feedback about the patients therapy~     progress.~   "
95590|NCT02315950|"~     With the goal of providing improved treatment to patients with overactive bladder symptoms~     (OAB), the investigators seek to apply the new technology of time-resolved (cine) MRI~     combined with urodynamics (UDS) to understand the exact effect of intravesical botulinum~     toxin on bladder physiology. The investigators will specifically aim to assess the~     physiological mechanism by which intravesical botulinum alleviates urgency and urge~     incontinence symptoms in women with OAB refractory to medical therapy.~   "
95591|NCT02315937|"~     Rationale: Spinal anesthesia is a safe, frequently used anesthetic technique. The main side~     effect of spinal anesthesia is hypotension, occuring in up to 85 % of selected cases. This~     hypotension is often treated with fluid infusion. However, especially in elderly patients,~     high volume fluid infusion can lead to fluid overload.~      The effects of spinal anesthesia on preload and fluid responsiveness are not exactly known.~     Hence, therapy for hypotension after spinal anesthesia might not be adequate. With~     transthoracic echocardiography, vena cava inferior diameter and collapsibility can be used to~     monitor fluid responsiveness and guide fluid management.~      Objective: This study has two main objectives. The first is to explore the effects of spinal~     anesthesia on hemodynamic parameters of fluid status, especially vena cava inferior diameter~     and collapsibility. The second goal is to test the interrater variability transthoracic~     echocardiography exams when performed by (trained) anesthesiologists.~      Furthermore, the correlation between vena cava inferior collapsibility and the occurence and~     degree of hypotension (defined as a decrease from baseline of >20% or a systolic pressure <~     90 mmHg) after spinal anesthesia will be explored.~   "
95592|NCT02315924|"~     Intracranial atherosclerosis is common vascular lesion in Asian acute stroke patients and~     intracranial atherosclerosis patients have high rate of coronary artery disease (CAD).~     Moreover, several studies showed obvious association of CAD and cerebrovascular stenosis,~     which had been proved to increase the risk of stroke after coronary revascularization~     including coronary bypass surgery or percutaneous coronary intervention. In addition, the~     efficacy and safety of combined coronary and cerebral intervention are not fully~     investigated. Hence, the aim of this study is to evaluate the prevalence and characteristics~     of coronary and cerebrovascular arteriosclerosis as measured by combined coronary and~     cerebral angiography, explore the relationship between inflammation, atherosclerosis-related~     markers and coronary and cerebral atherosclerosis and compare the efficacy and safety of~     simultaneous or staged coronary and cerebral interventional strategy in Chinese Patients.~      The coronary angiography and cerebrovascular angiography are performed for all participants.~     The combined strategy for coronary and cerebrovascular angiography is carried out routinely~     in the investigators institutions. Simultaneous strategy is considered as that performed via~     the same access and within the same day. Staged strategy is intended as that performed within~     7 days from the first procedure. The sequence of angiographies is established on an~     individual patient basis by the cardiovascular and neurointerventional team according to~     clinical symptoms of the patients and after coronary or cerebrovascular angiography. After~     combined coronary and cerebral angiography, simultaneous or staged interventional strategy~     will be performed in patients with severe coronary and cerebral stenosis. Blood sample is~     obtained from artery sheath when performing coronary or cerebral angiography. Lipid levels,~     inflammation and atherosclerosis-related markers will be measured in this study.~   "
95593|NCT02315911|"~     Randomized study on pediatric OSA with 2 groups: mild-moderate OSA and severe OSA.~     Mild-moderate are randomized to either expectancy or ATE. Severe are randomized to either ATE~     or APP. Pediatric age span of 2 until 4,9 years.~   "
95594|NCT02315898|"~     Plastic bronchitis (PB) is a rare, most often pediatric disease characterized by the~     formation of obstructive airway casts primarily composed of fibrin. There is presently no~     FDA-approved pharmacotherapy for PB, but acute exacerbations of the illness are often treated~     with inhaled tissue plasminogen activator (tPA). To date, this is done somewhat anecdotally~     because there has been no safety or efficacy testing of this treatment. In addition, there is~     presently no reliable surrogate marker of adverse drug events. Nevertheless, in the absence~     of inhaled tPA treatment, PB-induced respiratory distress can be severe, often warranting~     urgent or emergent bronchoscopy for cast removal, or can sometimes result in respiratory~     failure. As such there is a significant unmet need for safety and efficacy testing of inhaled~     tPA and for biomarkers of drug response.~      Objectives and Endpoints: The objectives of this protocol are to: 1) test the safety and~     efficacy of an inhaled tPA regimen in children with PB; and 2) identify potential candidate~     biomarkers of inhaled tPA drug response. Safety endpoints will consist of the development of~     new, active bleeding that is systemic and/or pulmonary and/or new hematuria (defined as gross~     hematuria). Secondary endpoints of efficacy will also be measured (e.g., frequency of cast~     production). Urine and blood will also be collected for the development of potential~     biomarkers of inhaled tPA drug response.~      Funding source- FDA OOPD~   "
95595|NCT02315885|"~     The purpose of the research study of the K23 award is to develop a blood test that can check~     how much alcohol a person has consumed in the past few days. We will enroll heavy social~     drinkers who do not have alcohol-related problems but used to drinking 5 or more beers on a~     single occasion. Both men and women between ages 21 and 65 years can join the study. All~     participants must be of European decent.~   "
95596|NCT02315872|"~     This is a study of Acthar gel (ACTH) in patients with relapsing multiple sclerosis who are~     experiencing chronic fatigue.~   "
95597|NCT02315859|"~     It is known that, at the end of the cardiac ejection period, potential energy is stored in~     elastic fibers of the heart, which promotes the suction of blood from the atria during early~     filling. The investigators have developed a new ultrasound-based method to quantify this~     suction effect. Here, it is necessary to reduce the complex 3-dimensional cardiac mechanics~     in a 1-dimensional (piston-like) pump system. In the study, several steps of model reduction~     will be tested. Each reduction is intended to allow non-invasive measurements to become~     increasingly simple and feasible at reduced echo quality. The reference method is the~     invasive data obtained from a pressure-volume conductance catheter. To increase the supply of~     potential energy in the elastic fibers, a substance (dobutamine) is administered for~     transient strengthening of the force of contraction.~      Hypothesis: There is a good agreement between the new, non-invasive parameters and the~     invasive reference method for the quantification of the suction effect of the left ventricle,~     and the good correlation persists even with increasing model simplification.~   "
95598|NCT02315846|"~     The level of acetylcholinesterase is suspected to correlate with postoperative delirium. The~     investigators therefore score patients once preoperatively and twice postoperatively with the~     german version of the delirium-score NuDESC (Nursing Delirium Screening Scale) and compare~     the results with the acetylcholinesterase activity, butyrylcholinesterase activity and the~     serum anticholinergic activity (SAA) at corresponding time points.~   "
95599|NCT02315833|"~     The purpose of this study is to validate the novel hypothesis that daily use of L-cysteine~     (Acetium® capsules) is an effective means to decrease the frequency of (or completely abort)~     the headache attacks in migraine patients.~   "
95600|NCT02315820|"~     The equipoise whether to Induce pregnant women with suspected large for gestational babies or~     suspected macrosomia babies at term pregnancy is not solved yet. Only 2 relatively small~     studies were conducted to answer this clinically important question.~      The investigators will conduct a randomized controlled, multi-center study large enough to~     confirm or refute our assumption that induction of labor at term reduces the shoulder~     dystocia prevalence significantly compared to expectant management.~   "
95601|NCT02315807|"~     Transcranial direct current stimulation has shown promising results in stroke patients. This~     study is a double blind, sham-controlled clinical trial aiming to compare the long-term~     effects of stimulation in two different cognitive regions after a stroke. Sixty patients who~     suffer from chronic strokes will be randomized into 1 of 3 groups: dorsolateral prefrontal~     cortex, cingulo-opercular network and motor primary cortex (control). Each group will receive~     transcranial direct current stimulation for 20 minutes for 10 consecutive working days (2~     weeks). Patients will be assessed with a Dysexecutive Questionnaire, Semantic Fluency test,~     categorical verbal fluency and Go-no go tests, Wechsler Adult Intelligence Scale, Rey~     Auditory-Verbal Learning Test, Letter Comparison and Pattern Comparison Tasks at baseline,~     after their tenth stimulation session (week 2) and endpoint (week 4). Those who achieve~     clinical improvement with neurostimulation will be invited to receive treatment for 12 months~     as part of a follow-up study.~   "
95602|NCT02315794|"~     Different studies have proposed the use of zirconia abutments to improve the aesthetic~     outcomes in the anterior sextant, however the results have been inconclusive. A tendency~     towards a better aesthetic result with the use of zirconia instead of titanium abutments was~     observed, although more technical complications were also recorded.The use of zirconia~     abutments in the anterior maxillary region showed a tendency towards better matching,~     although differences were not significant. In addition, with these abutments more technical~     complications were observed, what increased the cost and time. More studies with larger~     samples and longer observations periods are needed to recommend the use of zirconia abutments~     for this clinical situation~   "
95603|NCT02315781|"~     Parkinson's disease (PD) is a progressive neurological disease that has effects on both~     movement and mental health. One of the most common mental health complications of PD is~     depression. Up to 30% of Parkinson's patients will experience depression at some point. We~     aim to investigate whether transcranial direct current stimulation (tDCS), a type of~     electrical stimulation for the brain, can improve depression in PD as well as improve motor~     function in PD.~   "
95604|NCT02315768|"~     The purpose of the study is to determine whether ibrutinib in combination with GA101 -~     Obinutuzumab might be useful for the treatment of CLL. This study will evaluate if ibrutinib~     in combination with GA101 - Obinutuzumab can reduce the amount of cancerous cells in body.~   "
95605|NCT02315755|"~     Metastatic renal cell carcinoma (mRCC) is the most common malignant tumour of the kidneys.~     Targeted therapies, which were recently introduced in the treatment of mRCC, have become the~     standard treatment in these patients. With improved survival rate and a tolerable side effect~     profile, Tyrosine Kinase Inhibitors (TKIs) have largely replaced conventional immunotherapies~     worldwide.~      In Turkey, due to reimbursement conditions, cytokine (interferon alpha) treatment is the~     standard treatment as first-line therapy.~      Therefore, the data on quality of life (QoL) from the pivotal studies with standard TKI~     treatment does not reflect the QoL status of patients treated with TKIs as second or third~     line treatment in Turkey. In this study, the clinical outcomes and the impact on quality of~     life of targeted treatments following TKIs will be explored. To our knowledge, since there is~     no similar reimbursement condition in the world placing IFN as the first line standard~     treatment, this will be the first study evaluating the QoL status with targeted therapies~     used as 3rd line treatment in mRCC patients.~   "
95606|NCT02315742|"~     The purpose of this study is to see if walking is effective for improving memory,~     concentration thinking abilities, physical function and quality of life of adults 50 years of~     age and older living with HIV.~   "
95607|NCT02315729|"~     The purpose of this study is to identify potential markers for curve progression in~     adolescent idiopathic scoliosis (AIS). Despite its prevalence and impact on child health, the~     etiology of AIS and molecular mechanisms underlying its development and progression remain~     poorly understood. Clinical criteria and features cannot adequately predict which children,~     diagnosed with mild disease, will undergo subsequent curve progression requiring~     intervention.~      The investigators hypothesize that alterations in specific genetic markers will be correlated~     with the progression of AIS curves over time. Thus, these markers could be used in the future~     to develop a reliable, inexpensive and relatively non-invasive cell based diagnostic test to~     (1) predict spinal curve progression in AIS, (2) select patients likely to benefit from early~     surgical intervention, and (3) potentially screen for asymptomatic children at risk of~     developing idiopathic scoliosis.~   "
95608|NCT02315716|"~     The Cardamon trial is a phase 2 trial using the standard chemotherapy drugs cyclophosphamide~     and dexamethasone in combination with a new drug called Carfilzomib in patients with multiple~     myeloma.~   "
95609|NCT02315703|"~     The purpose of this study is to assess the safety and tolerability of various regimens~     containing adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV),~     Modified Vaccinia Ankara (MVA)-Mosaic, and/or HIV type 1 Clade C glycoprotein 140 drug~     product (gp140 DP) components and to compare envelope binding antibody responses between the~     different vaccine regimens.~   "
95610|NCT02315690|"~     This is a cluster randomised controlled trial comparing the impact of two community based~     malaria interventions: reactive case detection (RACD) vs reactive targeted presumptive~     treatment (focal mass drug administration, fMDA) on the incidence of malaria in Swaziland.~   "
95611|NCT02315677|"~     The purpose of this study is to determine the degree of epistaxis following nasal intubation~     with either a nasal endotracheal (RAE) tube with bevel facing left or Parker Flex-Tip~     endotracheal tube with bevel facing posteriorly~      The investigators hypothesize that a Parker Flex-Tip endotracheal tube when inserted with~     bevel facing posteriorly during nasal intubation may reduce the incidence of epistaxis intra~     and post-operatively. The investigators propose that using this style of endotracheal tube~     improves patient safety and comfort and facilitates ease and success of nasal intubation.~   "
95612|NCT02315664|"~     Physical activity is an essential first-line treatment for patients with knee osteoarthritis~     (OA). However, a 2013 systematic review found only 13% met the activity recommendation of 150~     minutes or more per week. The primary goal of this randomized controlled trail is to assess~     the efficacy of a physical activity counseling model, involving a group education session,~     the use of Fitbit Flex (a wireless physical activity tracking device), and online/telephone~     coaching by a physiotherapist (PT), to improve physical activity and reduce sedentary time in~     patients with knee OA. Engaging in regular physical activity can have the additional benefit~     of improving cognitive functioning.~   "
95613|NCT02315651|"~     The aim of this study is to evaluate the effects of nutritional supplement co-enzyme Q10~     (CoQ10) on methylphenidate-treated ADHD children in a randomized, double-blinded,~     placebo-controlled prospective study. All eligible patients will undergo randomization and~     divided into 2 groups: a CoQ10-enriched snack and a placebo snack group. According to power~     calculation, total of 60 subjects are expected to participate in the study. After the~     screening of eligibility (up to 14 days), the study is divided into three phases:~     pre-treatment (first assessment) phase (up to 14 days), treatment phase 8 weeks of treatment,~     and post-treatment phase. Screening: each participant will undergo screening for protocol~     eligibility within 14 days (two weeks) of recruitment. Subjects who meet all the inclusion~     criteria and signed an approved informed consent (both parents and the child) will be~     enrolled.~   "
95614|NCT02315638|"~     This is a long-term safety follow-up protocol for subjects who received TT-034 under the~     B2801001 protocol and consists of monitoring for at least 4.5 years.~   "
95619|NCT02315573|"~     This study is focused on comparing patients' pain scores on a visual analogue scale (VAS) and~     the difference in analgesics use post-operatively (with the same prescription defining only~     the maximum frequency) between lidocaine with epinephrine & bupivacaine with epinephrine as~     local anesthetics in wide-awake hand surgery. The investigators' hypothesis states that a~     longer acting local anesthetic agent (bupivacaine) would be able to provide better~     postoperative pain relief demonstrated by lower pain scores on VAS and less analgesics use~     (as will be recorded on the patient's log). This will be mainly obvious in the first 24 hours~     postoperative period when the pain is usually at maximum levels and starts to decline~     thereafter. If the investigators' hypothesis is true, this may potentially change practices~     of many hand surgeons towards the routine use of longer acting local anesthetics particularly~     in wide-awake hand surgery, and perhaps could be extrapolated to other surgical specialties.~     Further, a reduction in postoperative analgesics use would be of paramount clinical~     importance, as it would reduce their potential side effects.~   "
95620|NCT02315560|"~     To determine the effects of electrical stimulation of the nerves in the foot on the incidence~     of nocturnal enuresis (bedwetting) in children~   "
95615|NCT02315625|"~     Background:~      - Neuroendocrine tumors (NETs) come from cells of the hormonal and nervous systems. Some~     people have surgery to shrink the tumor. Sometimes the tumors come back. Researchers think~     that treatment with drugs based on knowing the defective gene might give better results.~      Objective:~      - To see if drugs selected based on the defective gene result in better tumor response. The~     drugs are sunitinib and everolimus.~      Eligibility:~      - People age 18 and older with an advanced low- or intermediate-grade gastrointestinal or~     pancreatic neuroendocrine tumor.~      Design:~      - Participants will be screened with:~      <TAB>- Medical history~      <TAB>- Physical exam~      <TAB>- Scans~      <TAB>- Blood, urine, and lab tests~        -  The study team will see if participants should have surgery.~        -  If yes, participants will:~        -  Sign a separate consent~        -  Have CT scan before and after surgery~        -  Have as much of the tumor removed as possible. A small piece will be tested for mutation~          type.~        -  If no, participants will have a small piece of tumor removed for the testing.~        -  If the surgery might cure them, the participant will leave the study. The other~          participants will be assigned to take either sunitinib or everolimus.~        -  Participants will take their drug by mouth once a day. They will keep a medicine diary.~          Some will keep track of their blood pressure at least weekly.~        -  Screening tests may be repeated at study visits. Participants also may have their heart~          evaluated.~        -  About 30 days after the last day of their study drug, participants will have a follow-up~          visit that repeats the screening tests.~        -  Participants will be contacted every 3 months after this visit.~   "
95616|NCT02315612|"~     Background:~      - One type of cancer therapy takes blood cells from a person, changes them in a lab, then~     gives the cells back to the person. In this study, researchers are using an anti-CD22 gene, a~     virus, and an immune receptor to change the cells.~      Objective:~      - To see if giving anti-CD22 Chimeric Antigen Receptor (CAR) cells to young people with~     certain cancers is safe and effective.~      Eligibility:~      - People ages 1-30 with a leukemia or lymphoma that has not been cured by standard therapy.~      Design:~        -  Participants will be screened to ensure their cancer cells express the CD22 protein.~          They will also have medical history, physical exam, blood and urine tests, heart tests,~          scans, and x-rays. They may give spinal fluid or have bone marrow tests.~        -  Participants may have eye and neurologic exams.~        -  Participants will get a central venous catheter or a catheter in a large vein.~        -  Participants will have white blood cells removed. Blood is removed through a needle in~          an arm. White blood cells are removed. The rest of the blood is returned by needle in~          the other arm.~        -  The cells will be changed in a laboratory.~        -  Participants will get two IV chemotherapy drugs over 4 days. Some will stay in the~          hospital for this.~        -  All participants will be in the hospital to get anti-CD22 CAR cells through IV. They~          will stay until any bad side effects are gone.~        -  Participants will have many blood tests. They may repeat some screening exams.~        -  Participants will have monthly visits for 2-3 months, then every 3-6 months. They may~          repeat some screening exams.~        -  Participants will have follow-up for 15 years.~   "
95617|NCT02315599|"~     Background:~      - Gene therapy involves changing the genes inside the body s cells to stop disease. It is~     very closely regulated. People who have had this therapy may have problems months or even~     years later. Researchers do not know the long-term side effects, so they want to study people~     who have had the therapy. They want the study to continue over the next 15 years.~      Objective:~      - To study over time the negative side effects from genetically engineered cellular therapy.~     This will be studied in people who have been in Pediatric Oncology Branch (POB) gene therapy~     trials.~      Eligibility:~      - People who are currently or were previously in a research study with gene therapy in the~     National Cancer Institute POB.~      Design:~        -  Participants blood will be tested right before they get the genetically changed cells.~          They will get the cells as part of another study.~        -  For the next year, they will come back to the clinic or see their doctor at home at~          least every 3 months. They will answer questions about their health and blood will be~          drawn.~        -  For the next 5 years, they will go to the clinic or see their own doctor once a year.~          They will have physical exam and blood will be drawn.~        -  For 10 years after that, they will be asked every year for health information.~        -  Participants will keep their contact information up to date with researchers. They may~          be phoned for more health information.~        -  If the participant was under 18 years old when given the gene therapy and turns 18~          during this follow-up, they will be asked to sign a new consent form when they turn 18.~   "
95618|NCT02315586|"~     Background:~      - Idiopathic pulmonary fibrosis (IPF) is a chronic lung disease that becomes worse over time.~     There is currently no effective treatment for it. Researchers want to study the disease and~     learn new ways to treat it.~      Objectives:~      - To discover new pathways that are involved in pulmonary fibrosis. To develop new drugs that~     may be used to treat pulmonary fibrosis.~      Eligibility:~        -  People at least 18 years old with IPF.~        -  Healthy volunteers at least 18 years old.~      Design:~        -  Participants will be screened with medical history, questionnaire, and physical exam.~          They will have blood, lung, and walking tests and chest scans.~        -  All participants will have 1 study visit, including:~        -  Medical history and physical exam.~        -  Questions about their breathing.~        -  Blood tests.~        -  Breathing tests.~        -  Six-minute walk test.~        -  Pregnancy test.~        -  Chest x-ray (healthy volunteers) or chest CT scan (people with pulmonary fibrosis ).~        -  Small area of skin may be removed.~        -  Genetic tests of blood and skin samples. Participants will probably not be informed of~          any findings. Samples may be used to make stem cells for use in research. Participants~          may be contacted in the future to give consent for this research.~        -  Some participants will have repeat visits over many years, repeating many of the study~          tests.~   "
95644|NCT02315248|"~     The purpose of this study is to validate a human saliva sample analyzer technique designed to~     screen for low bone density and osteoporosis. The analyzer technique is meant to be a simple,~     noninvasive, easy-to-use, cost-effective, and routine means of diagnosing bone turnover using~     a point-of-care device that monitors salivary markers of bone turnover in a screening patient~     population that is at risk for low bone density or osteoporosis.~   "
95645|NCT02315235|"~     To investigate the efficacy and safety of autologous peripheral blood stem cell based therapy~     in patients with diabetic painful neuropathy.~   "
95621|NCT02315547|"~     Study 1 is a cross-sectional investigation. Patients with clinically stable bronchiectasis~     (symptoms, including cough frequency, sputum volume and purulence, within normal daily~     variations) will undergo baseline assessment consisting of history taking, routine sputum~     culture, 16srRNA pyrosequencing, measurement of sputum inflammatory markers, oxidative stress~     biomarkers and MMPs, and spirometry. Microbiota taxa will be compared between bronchiectasis~     patients and healthy subjects.~      In study 2, patients inform investigators upon symptom deterioration. Following diagnosis of~     BEs, patients will undergo the aforementioned assessments as soon as possible. This entails~     antibiotic treatment, with slightly modified protocol, based on British Thoracic Society~     guidelines [16]. At 1 week after completion of 14-day antibiotic therapy, patients will~     undergo convalescence visit.~      Study 3 is a prospective 1-year follow-up scheme in which patients participated in telephone~     or hospital visits every 3 months. For individual visit, spirometry and sputum culture will~     be performed, and BEs will be meticulously captured from clinical charts and history inquiry,~     with the final decisions adjudicated following group discussion.~   "
95622|NCT02315534|"~     This is an open label, multi-center, phase 1 safety run-in and phase 2 study of BBI608 in~     combination with temozolomide in patients with recurrent or progressive glioblastoma who have~     not received prior bevacizumab therapy.~   "
95623|NCT02315521|"~     The investigators propose a standardized prenatal management, based on the scientific~     evidence published in the literature, to manage prenatally fetuses with lower urinary tract~     obstruction (LUTO). The present study is a prospective registry that will evaluate and~     validate this standardized prenatal management for LUTO.~   "
95624|NCT02315508|"~     This study aims to demonstrate that the new medicine AUT00063 is effective and safe in the~     treatment of tinnitus.~   "
95625|NCT02315495|"~     The proposed study is designed to evaluate (i) the effects of saxagliptin, with or without~     acarbose, on gastric emptying, postprandial glycaemia, and plasma intact GLP-1, insulin,~     C-peptide and glucagon after a high carbohydrate meal, and (ii) whether the magnitude of the~     effects of saxagliptin and/or acarbose is related to the rate of gastric emptying, in~     patients with type 2 diabetes.~   "
95626|NCT02315482|"~     The purpose of this study is to assess the different effects of pneumoperitoneum and steep~     trendelenburg position on autonomic nervous system modulation during laparoscopic~     prostatectomy~   "
95627|NCT02315469|"~     This research trial studies comprehensive patient questionnaires in predicting complications~     in older patients with gynecologic cancer undergoing surgery. Comprehensive patient~     questionnaires completed before surgery may help identify complications, such as the need for~     assistance in taking medications, decreased mobility, decreased social activity, and falls,~     and may improve outcomes for older patients with gynecologic cancer.~   "
95628|NCT02315456|"~     The study compares anatomic outcomes of Intra Ocular Lens(IOL) placement with two methods of~     centration of the capsulorhexis- scanned capsule centration and pupil centration. It is~     hypothesized that scanned capsule centration provides more uniform(25% better) overlap of~     capsulorhexis margin over IOL optic compared to pupil centration.~   "
95629|NCT02315443|"~     The purpose of this study is to determine whether NA-1 is effective in reducing global~     disability in patients with acute cerebral ischemia if administered early after symptom~     onset.~   "
95630|NCT02315430|"~     This phase II trial studies how well cabozantinib-s-malate works in treating patients with~     ovarian, fallopian tube, or primary peritoneal cavity cancer that has come back or is~     growing, spreading, or getting worse. Cabozantinib-s-malate may stop the growth of tumor~     cells by blocking the growth of new blood vessels necessary for tumor growth and also by~     blocking some of the enzymes needed for cell growth.~   "
95631|NCT02315417|"~     The study will evaluate the efficacy and safety of gevokizumab in treating active ulcers of~     pyoderma gangrenosum (PG).~   "
95632|NCT02315404|"~     Gastrointestinal bleeding originating from the small bowel is difficult to diagnose and treat~     because the small bowel is difficult to see and reach. Balloon assisted enteroscopy (BAE) is~     a new enteroscopy methods that allow examination of the small bowel and allows for diagnosis~     and treatment of bleeding originating from this part of the intestine. Unfortunately, BAE is~     unsuccessful in identifying the cause of bleeding in 40-50% of patients. This may be due to~     limited visualization of the small bowel lining during conventional endoscopy. One way to~     improve visualization of the small bowel lining is by adding a transparent plastic cap to the~     end of the endoscope (camera), which allows the endoscope to see around sharp turned and~     behind folds in the small bowel.~      The investigators goal in this randomized controlled study is to see if adding a transparent~     cap to the end of the endoscope will help to identify and treat small bowel bleeding. The~     investigators will invite patients referred for BAE to participate in the study; the~     alternative to participating in the study is having standard BAE (without a cap). If patients~     choose to participate in the study they will be randomized to BAE with or without a cap on~     the end of the endoscope. Subjects time commitment will be limited to the consent process and~     pre-procedure paperwork at time of initial endoscopy and time required to complete telephone~     questionnaire at 12 months follow up.~   "
95633|NCT02315391|"~     The primary objective is to determine the effect of reduced activity on the stimulation of~     myofibrillar FSR with protein feeding in the elderly.~   "
95646|NCT02315222|"~     Patient with periodontal disease undergoing full mouth disinfection will be given dietary~     supplements or placebo and reevaluated after 3 months.~   "
95647|NCT02315209|"~     Outpatient services in Germany are less controlled by external quality assurance programs.~     Comprehensive outcome data for benchmarking or health-care decision-making are missing e.g.~     for day case surgery. A quality-of-life instrument specific to hernia repair with mesh has~     been recently proposed (Carolinas Comfort Scale, CCS) .This study evaluates the integration~     of CSS as part of a multicentre quality assurance scheme for day-case (outpatient)~     surgery.b.The Study Group on Quality assurance in ambulatory hernia surgery has developed~     and standardized Operation technique for 3D Implants. As a consequence, any deviation must be~     documented by the standard. The extension to other centers according to a standardized~     protocol took place (shadowing to learn the operational standards, training in documentation,~     Minimum quantity 30 interventions per year, etc.).~   "
95634|NCT02315378|"~     This study is a randomized controlled trial to investigate the feasibility and effectiveness~     of a brief Anxiety Reduction Treatment for Acute Trauma (ARTAT) with adults (over age 18)~     showing signs of peritraumatic anxiety in the Emergency Department of Bellevue Hospital, New~     York in the hours following a psychologically traumatic event. Thirty-six participants will~     be enrolled over a 12-month period: 18 receiving ARTAT and 18 receiving Treatment As Usual~     (TAU). The study will target anxious arousal in patients immediately (1 to 8 hours) following~     a trauma. Participants will be recruited from among patients who present in the Emergency~     Department at Bellevue Hospital for treatment of an injury sustained in a traumatic event~     (accident, assault) as long as injuries do not preclude participation. Participants included~     in the study will have experienced a trauma within 8 hours and presenting with signs of a~     strong risk factor for PTSD: peritraumatic panic (severe psychological and physiological~     anxiety symptoms such as fear of dying, fear of losing emotional control, tachycardia,~     sweating, shaking and dissociation symptoms such as derealisation and depersonalization that~     occur during and immediately following a trauma. Following the initial assessment, eligible~     participants will be randomized to receive the one-hour anxiety-reduction intervention~     designed to reduce anxiety and panic symptoms through education and anxiety y management~     skills or TAU. The clinician administered and self-report assessments will be conducted at~     screening, baseline, post-treatment, weekly, and at a one-month and three-month follow-up.~   "
95635|NCT02315365|"~     This real-life Health Economics and Outcome Research (HEOR) study will enable to assess the~     impact of current therapies on quality of life (QoL), productivity loss and health care~     resource utilization in metastatic breast cancer (mBC). This prospective study will estimate~     patient-reported outcomes (PROs) and resource utilization data for mBC patients stratified~     according to treatment type, treatment line and disease status (progression vs. progression~     free) in a real-life setting.~      To estimate QoL, work productivity and health care resource utilization of post-menopausal~     patients with ER+/HER2- locally advanced or metastatic breast cancer in a real-life setting.~     The secondary objective is to estimate QoL and work productivity of mBC patients' caregivers.~      During the course of the study, data will be collected on quality of life and work~     productivity. Patients and caregivers will be asked to fill a set of questionnaires at their~     recruitment in the study, at 3 months and at 6 months after recruitment.~   "
95636|NCT02315352|"~     The primary objective of the trial is to compare the overall palatability of the new orally~     disintegrating L-Praziquantel (L-PZQ ODT), the new racemate PZQ ODT (Rac-PZQ ODT) and the~     current available racemate PZQ tablets (reference) as assessed by means of human gustatory~     sensation tests (100 millimeter [mm] visual analogue scale [VAS] scoring modified by the~     incorporation of a 5 point facial hedonic scale).~      The secondary objectives are~        -  To obtain feedback from children regarding the taste of different formulations using an~          open ended questionnaire~        -  To document any discomfort or other observation in relation to acceptance of the study~          medication~   "
95637|NCT02315339|"~     The European Home Mechanical Ventilation Registry (EHMVR) will enable a thorough evaluation~     of HMV by documenting the characteristics of HMV patients and their treatment. This will~     facilitate a prospective, observational study to identify the primary indications for HMV,~     describe patterns of HMV use in European countries, and characterize changes in the~     initiation and utilization of HMV over time. The registry will target all adult individuals~     who have an indication for HMV. In the EHMVR, patient data from routine clinical care will be~     documented using an electronic case report form (eCRF). The eCRF will record: patient~     demographic data; diagnostic information (including primary diagnosis, 6-minute walk time,~     the presence of depression, and quality of life); blood gases; ventilation treatment~     (including type of ventilator, modes and settings, interfaces used); follow-up data~     (including failure rates, side effects, technical issues). An initial Pilot Phase will be~     launched with the aim to enrol at least 200 patients over a 6-month period to determine the~     feasibility of the registry. Steering committee members and their institutions will be the~     main participants in the Pilot Phase. After completion of the Pilot Phase, the registry will~     be expanded across Europe with the goal of enrolling approximately 10,000 patients over 5~     years.~   "
95638|NCT02315326|"~     The purpose of this study is to test any good or bad effects of the study drug called of~     ibrutinib (also known as Imbruvica™) at 840mg daily dosing has on the patient and the~     lymphoma in the central nervous system.~   "
95639|NCT02315313|"~     It is a retrospective study with no products limitation to investigate the link between~     clinical resting HR and SOA. Use HR≤60bpm as control group, compare other three groups with~     the control group and find out the correlation between HR and SOA indexes.~   "
95640|NCT02315300|"~     Patients with insulin-dependent diabetes mellitus (DM) and chronic kidney disease (CKD)~     exhibit an excessive risk for cardiac arrhythmias, in particular sudden cardiac death (SCD).~     Hypoglycemia is a frequent problem in insulin-treated patients, especially in those with CKD,~     and various studies have shown that hypoglycemic episodes are strong predictors of~     cardiovascular mortality in both type 1 and type 2 diabetic patients. Experimental data and~     small clinical studies link hypoglycemia with ECG changes and SCD, but little is known about~     the direct association of hypoglycemic events and/or rapid swings in blood glucose with~     arrhythmias in this high risk population. Ideally, an algorithm should help to identify~     patients at risk for hypoglycemia-associated arrhythmias and SCD, but hitherto systematic~     analyses of blood glucose values and 12-channel ECGs are lacking in these patients.~   "
95641|NCT02315287|"~     Triple combination of metformin, DPP4 inhibitor and Thiazolidinedione would be a good option~     in the treatment of drug-naïve Korean type 2 diabetic patients. Newly developed~     thiazolidinedione, Lobeglitazone would be not inferior to Pioglitazone.~   "
95642|NCT02315274|"~     Hypothesis:~      Increased contact with the diabetes care team throughout pregnancy will lead to improved~     glucose control during pregnancy.~   "
95643|NCT02315261|"~     This study aims to evaluate the effectiveness of the epidural analgesia in patients having~     elective thoracic and abdominal surgery under general anesthesia combined with epidural~     analgesia in Siriraj Hospital.~   "
95672|NCT02314884|"~     A Phase I, Open-label, Dose-escalation Study to Assess the Safety, Tolerability,~     Pharmacokinetics and Preliminary Anti-tumor Activity of Cafusertib Hydrochloride in Patients~     With Advanced Solid Tumors~   "
95648|NCT02315196|"~     This phase II trial studies how well pegylated liposomal doxorubicin hydrochloride and~     carboplatin followed by surgery and paclitaxel work in treating patients with stage II-III~     breast cancer that does not have estrogen receptors, progesterone receptors, or large amounts~     of human epidermal growth factor receptor 2 (HER2)/neu protein (triple negative). Drugs used~     in chemotherapy, such as pegylated liposomal doxorubicin hydrochloride, carboplatin, and~     paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Giving pegylated~     liposomal doxorubicin hydrochloride and carboplatin before surgery may make the tumor smaller~     and reduce the amount of normal tissue that needs to be removed. Giving pegylated liposomal~     doxorubicin hydrochloride and carboplatin followed by surgery and paclitaxel may be an~     effective treatment for breast cancer.~   "
95649|NCT02315183|"~     Acute kidney injury (AKI) complicates over 25% of cardiac surgical procedures where it~     increases mortality up to fourfold. The incidence of AKI is increasing, the pathogenesis is~     poorly understood, current diagnostic tests lack specificity and sensitivity, and there is no~     effective treatment. Improving outcomes in patients at risk of AKI has recently been defined~     as an NHS priority. The primary aim of this study is to determine how plasma derived~     microvesicles (MV) or more specifically MV associated microRNAs (miRNA) regulate survival and~     signalling in post cardiac surgery AKI. The study involves a clinical and experimental~     research project that will combine laboratory analyses of circulating MV and miRNA from~     clinical studies. The study will specifically consider how MV and miRNA alter inflammatory~     signaling in kidneys after cardiac surgery, how these are modified by important clinical risk~     factors, and whether they may serve as early biomarkers of injury.~   "
95650|NCT02315170|"~     To determine if a novel intraocular injection guide (IIG) reduces patient discomfort during~     and after intravitreal injections.~   "
95651|NCT02315157|"~     This phase I trial studies the side effects and best dose of bendamustine hydrochloride in~     treating patients with previously treated multiple myeloma. Drugs used in chemotherapy, such~     as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading.~   "
95652|NCT02315144|"~     The primary objective of the study is to characterize the safety profile and duration of~     bronchodilation of a single dose of inhaled TV48108.~   "
95653|NCT02315131|"~     The primary objective of the study is to characterize the safety profile and duration of~     bronchodilation of a single dose of inhaled TV46017~   "
95654|NCT02315118|"~     Despite advancement in chemotherapy, radiotherapy and haematopoietic stem cell transplant~     (HSCT), and the recent introduction of more targeted therapies, a substantial proportion of~     patients with B-cell malignancies, such as B-cell chronic lymphocytic leukemia (CLL) and~     B-cell non-Hodgkin's lymphoma (NHL) still succumb to their malignancies. For CLL and~     low-grade NHL, cure is achievable only with HSCT but such aggressive approach is not~     justified as the initial therapy for most patients who have indolent disease; when disease~     has progressed, transplant is either not feasible or ineffective. For high-grade B-cell NHL,~     the availability of Rituximab has improved disease outcome but treatment failure portends~     nearly inevitable death from disease or treatment-related complications. Thus, newer, more~     effective therapies for patients with B-cell malignancies are urgently needed.~      The present study translates recent laboratory findings into clinical application. In~     patients with B-cell malignancies receiving the anti-CD20 antibody Rituximab as standard~     therapy, the study aims to assess the feasibility and safety, as well as explore the~     efficacy, of infusing autologous T-lymphocytes engineered to express a CD16-41BB-CD3zeta~     chimeric receptor which mediates antibody-dependent cell cytotoxicity. Receptor expression is~     achieved by electroporation of mRNA.~   "
95655|NCT02315105|"~     The purpose of this study is to find out more about the safety and effectiveness of the~     Laparoscopic Greater Curvature Plication (LGCP) procedure in patients with obesity and~     related problems such as diabetes, hypertension, high cholesterol, mild obstructive sleep~     apnea, and joint problems. LGCP is a less invasive weight loss surgery procedure than some of~     the other weight loss surgeries and it is possible that there are fewer risks with this~     procedure than with the other weight loss surgeries. LGCP is considered an experimental~     procedure and this study is being done to look at the long-term outcomes.~   "
95656|NCT02315092|"~     The current trial aims to compare the assessment of diabetic foot ulcers by fluorescence~     image guidance to standard practice. The device will be used to acquire fluorescence images~     of diabetic foot ulcers: when wounds are illuminated by violet/blue light, most pathogenic~     bacterial species emit a unique red fluorescence signal. The device is intended to be used as~     part of the clinical assessment process, which may include visual assessment, signs of heat~     or high temperature, the presence of exudate, and redness in the area. Images will guide the~     clinician to inspect, sample or further evaluate areas where fluorescing bacteria is present.~     This study will allow us to determine the benefit of fluorescence image-guided procedure as~     compared to standard clinical practice to assess bacterial burden in diabetic foot ulcers.~     Microbiological swabbing under standard practice and fluoresce-guided imaging will be~     performed in order to compare the two techniques.~   "
95657|NCT02315079|"~     To evaluate the use of a point of care device to measure markers of inflammation in various~     eye conditions. In particular, matrix metalloproteinase-9 (MMP-9) will be measured. MMP-9 is~     an enzyme that plays a role in inflammation. The value obtained with the point of care device~     will be correlated with values obtained using gel electrophoresis to measure MMP-9 from the~     same sample. These data will be compared to clinical exam findings and questionnaires to help~     the investigators better understand the role of this marker of inflammation in eye diseases~     and possibly improve diagnostic abilities.~   "
95658|NCT02315066|"~     To assess the safety and tolerability at increasing dose levels of PF-04518600 alone or in~     combination wtih PF-05082566 in patients with select advanced or metastatic carcinoma in~     order to determine the maximum tolerated dose and select the recommended Phase 2 dose.~   "
95659|NCT02315053|"~     A prospective observational study to determine the prognostic value of the timing of 50%~     reduction in metabolic activity (T50) during CCRT for NSCLC for treatment outcome (PFS).~   "
95660|NCT02315040|"~     Overall Study Design and Plan Description~        -  The study will be conducted on women with fertility difficulties who are designated for~          intrauterine insemination treatment (IUI). The research sample size is 137 treatment~          cycles per group (total of 274 treatment cycles). The women will be randomly divided~          into two groups. Some will undergo the standard bolus IUI treatment and others will be~          treated with the EVIE Slow Release Insemination method (SRI). Women who fail to conceive~          in the first treatment will next receive the alternative treatment. This means that a~          woman treated with the IUI method who does not become pregnant will then be treated with~          SRI, and vice versa (crossover method). The study will include women treated with~          Clomiphene Citrate or with other Gonadotropin-based treatment. Every couple treated will~          undergo at least 2 insemination cycles (unless pregnancy has already been achieved).~        -  Before beginning the hormone treatment, each couple will have the trial procedure~          explained to them. This explanation will include all the detailed information and~          instruction about the IUI and the Slow Release Insemination methods. A Patient~          Information Sheet will be available to them.~        -  Preparation of the spermatozoa for intra uterine insemination will be identical to the~          method performed currently before IUI.~      Approximately two weeks after the insemination treatment, a blood sample will be taken from~     the woman to check for Beta hCG levels to indicate pregnancy.~      Hypothesis:~      SRI leads to higher pregnancy rates compared to standard IUI~      Primary endpoint:~      • Pregnancy rate Effect of controlled Intra-uterine slow release insemination on the~     pregnancy rate of women designated for intra uterine insemination in comparison to the~     accepted IUI method.~   "
95661|NCT02315027|"~     The purpose of this study is to determine whether mesenchymal stem cells (MSCs) can be safely~     delivered to the cerebrospinal fluid (CSF) of patients with multiple system atrophy (MSA).~     Funding Source - FDA OOPD.~   "
95662|NCT02315014|"~     To determine whether a balanced total daily dietary protein distribution supplemented with~     whey protein during a weight-loss intervention will result in increased muscle protein~     synthesis~   "
95663|NCT02315001|"~     A single-centre double-blind placebo-controlled crossover randomised controlled trial to~     determine the physiological basis of glucagon-like peptide-1 receptor activation on exercise~     haemodynamics, as manifest through specific electrophysiological parameters measured by~     serial exercise stress testing, in those patients with reversible myocardial ischaemia and~     obstructive coronary artery disease confirmed by a baseline exercise test and coronary~     angiography respectively.~   "
95664|NCT02314988|"~     This study is designed to evaluate the efficacy of topical tranexamic acid to reduce~     perioperative blood loss, reduction in postoperative drain output and allogenic transfusion~     requirements.~      The proposed study will be a prospective, randomized, double-blind (subject, surgeons,~     investigators, research coordinators) placebo-controlled study. Patients following high~     energy trauma who have sustained thoracic or lumbar spine fractures, dislocations or~     ligamentous injury with resultant instability requiring posterior spinal fusion will be~     enrolled for this study. Furthermore, patients undergoing elective complex deformity surgery~     will also be enrolled. Both populations of patients will be randomized into two groups. Group~     I will receive standard of care operative fixation with topical tranexamic acid intervention~     (test); Group II will receive standard of care operative fixation with normal saline~     (placebo) intervention. This study will have a 2-year follow-up and will consist of three~     periods: screening/enrollment phase up to 21 days from the day of injury to the day of~     randomization and operative intervention, an inpatient data collection period for 4 days~     postoperative, and then a follow-up period for 2-years postoperative (visits occurring at 2~     week, 16 week, 1 year, and 2 year) time points.~   "
95665|NCT02314975|"~     The aim of this study is to compare the clinical efficiency of conventional fixed appliance~     orthodontic treatment with that supplemented by the daily application of cyclic forces to the~     dentition via a removable (AcceleDent) vibrational appliance. The primary outcome measure is~     rapidity of tooth alignment; whilst secondary outcome measures include pain and discomfort~     during treatment, rapidity of orthodontic space closure, changes in arch dimensions and root~     length.~   "
95666|NCT02314962|"~     Diagnostic comparison between PET/CT and PET/MRI with integrated perfusion measurement in CT~     and MR. Study aim is to gain knowledge about additional value of CT perfusion and MR~     perfusion in solid tumors concerning tumor physiology, diagnostic accuracy and possibly~     prognostic.~   "
95667|NCT02314949|"~     An immunomodulatory protocol, experimentally-proven to promote T-regulatory dependent graft~     protective mechanisms was applied in a clinical cohort of 13 intestinal transplant recipients~     to activate - in a protolerogenic environment - T-regulatory cells.~      This protocol is the standard of care in the investigators intestinal transplant programme~     since the first intestinal transplant was performed in october 2000.~   "
95668|NCT02314936|"~     This study will investigate the effectiveness of Polydextrose, a dietary fiber, at increasing~     Colonic Transit Time and decreasing the gastrointestinal symptoms of Functional Constipation.~     One quarter of the subjects will receive 12 g of Polydextrose daily, one quarter will receive~     8 g of Polydextrose daily, one quarter will receive 4 g of Polydextrose daily and one quarter~     will receive a placebo daily.~   "
95669|NCT02314923|"~     Ebola virus has infected and killed people, mostly in Africa. In 2014, the Ebola virus has~     affected several thousand people. There is no approved effective way to treat or prevent~     Ebola. Researchers are trying to develop a vaccine for it. This is a study of the anti-Ebola~     vaccine BPSC-1001 to see if it is safe and to see how it affects people's immune system.~   "
95670|NCT02314910|"~     If implants are osseointegrated, there might be innervation of the bone close to the~     implants. This event might explain the so-called osseoperception phenomena: Functioning with~     implant-supported oral prostheses is better than with removable prostheses due to physiologic~     integration and thus sensory feedback.~   "
95671|NCT02314897|"~     Background and Aims Pacemaker implantation for treating bradyarrhythmias typically involves~     placing a pacing lead through the tricuspid valve (TV) into the right ventricular (RV) apex.~     It is now known that tricuspid regurgitation (TR) frequently results from this and may lead~     to increased morbidity or mortality. Recently, left ventricular (LV) pacing through an~     epicardial vein via the coronary sinus has been widely practiced due to the advent of~     biventricular pacing. This lead does not cross the TV, potentially reducing the risk of TV~     dysfunction and may also reduce the risk of LV dysfunction. The investigators hypothesize~     that LV pacing will prevent the onset of new TR or worsening of pre-existing TR in patients~     undergoing pacemaker implantation.~      Methods Patients receiving a pacemaker for sick sinus syndrome (n=20) with an LV ejection~     fraction <40% will be randomly allocated to receive either conventional RV pacing or LV~     pacing via the coronary sinus. Serial 2D and 3D transthoracic echocardiography will be~     performed before implantation, one day post implantation, then at 1 week, 1 month, 6 months~     and 1 year. The primary endpoints will be new onset TR and the diagnosis of at least moderate~     TR. Other endpoints include biventricular function, ventricular dyssynchrony, complications~     of device implantation, mortality and major cardiovascular events.~   "
95673|NCT02314871|"~     The aim of this study is to compare the effects of three types of perioperative analgesia on~     the number of circulating cancer cells (representing minimal residual disease) following~     radical colon cancer surgery. Patients will be randomized into one of three groups. The~     intervention group will receive combined regional and general anesthesia during surgery and~     postoperative epidural analgesia. The two control groups will receive balanced general~     anesthesia and either morphine-based or piritramide-based postoperative analgesia. We~     hypothesize that epidural analgesia will be favorable to both piritramide-based and~     morphine-based analgesia and that piritramide-based analgesia will be favorable to~     morphine-based analgesia with regard to the number of circulating cancer cells and its~     development in the early postoperative period.~   "
95674|NCT02314858|"~     Obstructive Sleep Apnea (OSA) is seen in approximately 6% of Americans. It is a serious~     medical condition with significant medical and psychological consequences, including~     diabetes, hypertension, and cardiovascular disease. The treatment of choice for OSA is~     Positive Airway Pressure therapy (PAP). PAP supplies positive pressure to the upper airway~     creating a pneumatic splint to keep the airway open during sleep. Adherence to PAP is~     notoriously low, with as few as 50% reaching minimal guidelines for adherence. One~     comprehensive review of adherence research found that adherence to PAP was less than that for~     any other medical disorder. The problem of adherence is significant not only because of the~     medical consequences that can ensue, but also because third party payers have begun to refuse~     to pay for PAP therapy when adherence is less than optimal, even in the face of clinical~     improvement. This is a critical time to address this problem.~      This research study is designed to identify methods that may help people respond to PAP, the~     most common therapy for OSA. Identifying these methods may be an important way to better care~     for patients with obstructive sleep apnea. With this research, the investigators hope to find~     ways to help people have a better response to treatment and a better quality of life.~   "
95675|NCT02314845|"~     The purpose of this randomized single center study is to determine the individual PEEP value~     that produces the best possible compromise of lung collapse and lung hyperdistention.~     Patients submitted to general anesthesia and mechanical ventilation during surgery~     (laparoscopy and open surgery) will participate. A PEEP titration procedure will be performed~     and the optimal PEEP value will be determined by electrical impedance tomography (EIT). An~     ultrasound will be used to record each step of the PEEP titration procedure in a sub-sample~     of patients. A total of 40 patients will be mechanically ventilated using physiological tidal~     volume (TV=6mL/kg of IBW) and fraction of inspired oxygen (FIO2) of 0.5 and will be~     randomized to one of two groups: optimal PEEP or a low PEEP (4cmH2O). Lung collapse and~     mechanics will be monitored by EIT throughout the intraoperative period. After extubation, a~     lung CT will be performed to evaluate the amount of lung collapse.~   "
95676|NCT02314832|"~     Blocking sensation from the femoral nerve by injecting local anesthetic around the nerve~     plays an important role in pain control after total knee replacement. However, femoral nerve~     block has been associated with increased risk of falls due to weakness of the thigh muscle.~     This prospective, randomized controlled trial asks the question whether blocking the more~     distal branch of the femoral nerve (saphenous nerve) will result in less muscle motor block,~     and thus less risk of falls. The study also aims to compare pain control after both~     techniques.~   "
95677|NCT02314819|"~     Fruquintinib administered at 5mg once daily(QD) in 4 weeks treatment cycle (three weeks on~     and one week off) was well tolerated and demonstrated encouraging preliminary clinical~     antitumor activity in patients with metastatic colorectal cancer (CRC) in phase Ib and phase~     2 study. This study is aimed to evaluate the efficacy and safety of Fruquintinib in the~     treatment of patients with metastatic CRC who have progressed after second line or above~     standard chemotherapy~   "
95678|NCT02314806|"~     The patients undergoing axillary lymph node dissection were randomized into 3 groups:~     patients undergoing lavages with normal saline (Group 1), patients undergoing lavage~     gentamicin solution (Group 2) and patients undergoing lavage with a clindamycin solution~     (Group 3). Drainage volume discharge is investigated~   "
95679|NCT02314793|"~     The purpose of this study is to evaluate the safety and tolerability of single ascending oral~     doses of ASP2205 in healthy young male and female subjects. This study will also evaluate the~     safety and tolerability of multiple ascending oral doses of ASP2205 in healthy young and~     elderly female subjects.~   "
95680|NCT02314780|"~     Ischemia reperfusion injury may be attenuated by HO-1 induction. Our previous data confirmed~     strong HO-1 induction in peripheral blood cells following heme arginate infusion in healthy~     humans5. Furthermore, we could demonstrate the amelioration of experimental ischemia~     reperfusion injury in the calf musculature by heme arginate in healthy subjects as measured~     by functional MRI6.~      Therefore, we propose that HO-1 induction in the human heart may be a suitable target to~     mitigate cardiac ischemia-reperfusion injury.~      The HO-1 induction will be assessed in a clinical trial by myocardial biopsy prior to and~     after aortic cross clamping in subjects with or without preceding heme arginate treatment in~     two different dosages. The HO-1 expression will also be measured in the clinical trials in~     peripheral blood mononuclear cells. As additional outcome, levels of myoglobin,~     creatine-kinase and troponin T and reactive oxygen species will be measured in plasma~     according to standard laboratory procedures.~   "
95681|NCT02314767|"~     Lohja Depression Treatment Study is a randomized treatment trial which compares three~     approaches for treatment of depression:1) Interpersonal Psychotherapy (IPT), 2)~     Psychoeducational Group Treatment ( PeGT) and 3) Treatment as Usual (TAU). This Trial aims to~     test and adapt known short term treatment models for Finnish patients and circumstances.~   "
95682|NCT02314754|"~     To demonstrate non-inferiority of the efficacy of 200 mg mifepristone followed in 24 to 48~     hours by 800 µg buccal misoprostol in outpatient medical abortion services among women 71-77~     days' compared to women 64-70 days' LMP.~   "
95716|NCT02314312|"~     Single center, open-label randomized-control trial Population: de novo 48 kidney transplant~     recipients (age 18-75 years) from ECD/AKI donors Compare: everolimus with low dose CNI and~     prednisolone versus standard immunosuppressive regimen Objective: To evaluate efficacy of~     everolimus with low dose CNI in de novo kidney transplant recipients of ECD/AKI donors~     Primary endpoint: Mean eGFR (CKD-EPI) at 12 months post-transplantation~   "
95683|NCT02314741|"~     The investigators wish to monitor the adoption of a new, incisionless approach to performing~     a Heller myotomy for the surgical treatment of achalasia. The method, the Peroral Endoscopic~     Myotomy (POEM), will provide less-invasive treatment for esophageal achalasia, ideally~     providing similar if not better outcomes (safety and efficacy) as the Heller myotomy. The~     investigators hope to enroll 10 patients with a clinical diagnosis of achalasia who meet~     inclusion criteria.~      The POEM procedure has been done in many hospitals without any research associated with it.~     Dr. Ginsberg, Dr. Chandrasekhara and Dr. Kochman will perform the procedures after being~     trained. Dr. Ginsberg has personally witnessed the performance of 10 POEM procedures and has~     performed in a swine model. The PI is credentialed to initiate POEM at HUP with the first~     case to be proctored by an experienced operator. The PI will then proctor the other adopters.~     The investigators would like to evaluate the safety of it and the effectiveness of it. The~     investigators will use their symptom scores and radiology tests pre- and post-POEM to~     evaluate effectiveness.~   "
95684|NCT02314728|"~     Premature rupture of membranes (PROM) is diagnosed by demonstrating amniotic fluid in the~     vaginal canal before the onset of labor. The integrity of the amniotic membrane is~     compromised thereby increasing the risk of intrauterine infection and compression of the~     umbilical cord. PROM complicates 3% to 8% of pregnancies in the US and is responsible for 30%~     of preterm births. Intrauterine infection remains the most significant maternal and neonatal~     sequelae associated with PROM and this risk increases with the length of time from ruptured~     membrane to delivery. Induction of labor has been shown to reduce the rates of~     chorioamnionitis, endometritis and NICU admissions4. Specifically, induction of labor with~     prostaglandin agents followed by oxytocin, versus oxytocin alone has been shown to be~     effective for labor induction resulting in vaginal delivery. Management strategies for PROM~     have been controversial, and published studies on outcomes are over one to two decades old,~     which does not account for changes in clinical trends and practice patterns. Recently ACOG~     recommends that patients presenting at 37 weeks gestation or greater with PROM should be~     induced if not in labor, and generally with oxytocin. In women with PROM without the onset~     of labor, the cervix is commonly unfavorable and induction with oxytocin alone may lead to an~     increased risk of cesarean section. With a c-section rate as high as 33%, women undergoing~     induction of labor have an increased risk of c-section and its associated morbidity and long~     term sequela. ACOG's recommendation for the use of oxytocin as the induction agent may be~     meant to avoid a theoretical increased risk of chorioamnionitis in this patient population~     however it does not take into account the status of the cervix, which may result in a~     increased risk of c-section. The purpose of the proposed study is to determine whether~     cervical ripening in women with PROM and an unfavorable cervix is associated with increase~     rates of vaginal delivery and decreased cesarean section rate compared to induction of labor~     with oxytocin alone. The investigators aim to determine the incidence of endometritis, and~     neonatal infection associated with PROM in the current medical environment of antibiotic~     prophylaxis and antenatal steroid use, taking into account the changes in patient~     characteristics.~   "
95685|NCT02314715|"~     Arthritis is one of the most prevailing causes of disability with knee osteoarthritis (KOA)~     the most common form. The lifetime risk of developing symptomatic KOA by the age of 85 years~     is 44.7%, where females are at a greater risk (1.8 times) than male counter parts. KOA is the~     leading cause of limitations in activities of daily living such as walking and climbing~     stairs particularly in the elderly. This is primarily due to pain and instability of the~     joint resulting in buckling of knees caused by muscle weakness, joint stiffness and damage.~     Patients with KOA have larger variations in muscle strength and are unable to maintain a~     target force combined with impaired ability to perceive joint movement and positioning~     suggests impaired neuromuscular control (NC) may influence KOA. NC refers to the nervous~     system's control over muscle activation contributing to task performance. This study aims to~     establish the role of loss of NC in biomechanical determinants and health outcomes of KOA.~   "
95686|NCT02314702|"~     MicroPort Orthopedics (MPO) is conducting this PMCF study to evaluate the safety and efficacy~     of its THA and resurfacing components marketed in the EU. These types of studies are required~     by regulatory authorities for all THA and resurfacing devices that do not have medium to~     long-term clinical evidence available at the time of gaining approval to market in the EU.~     This study has been designed in accordance with MEDDEV 2.12/2 rev 2.~   "
95687|NCT02314689|"~     The purpose of this study is to assess the maximum tolerated dose, safety and~     pharmacokinetics of an investigational drug, intravenous (IV) citrulline, in subjects in~     steady-state sickle cell disease.~   "
95688|NCT02314676|"~     This study evaluates the safety and efficiency of Pegylated Somatropin (PEG Somatropin)~     Injection in the treatment of endogenous growth hormone deficiency (GHD) in the broad~     population of children. Half of participants will receive the high dose, while the other half~     will receive the low dose.~   "
95689|NCT02314663|"~     Background In subjects with hypercholesterolaemia, cholesterol values remain above guideline~     levels. One of the limiting factors to the achievement of goals in such patients is~     therapeutic non-adherence. The aim of this study is to assess the effectiveness of an~     intervention designed to improve control of hypercholesterolaemic patients, consisting of a~     combined strategy that would include the delivery of printed information,~     treatment-compliance check cards and the dispatch of text messages as complementary measures~     in support of the intervention at the general practitioner's practice.~      Methods/Design A randomised, parallel-group clinical trial will be conducted at the family~     medicine outpatient facilities of eight health centres in three of Spain's Autonomous~     Regions, covering a total of 358 subjects aged 18 years or over with diagnosis of~     hypercholesterolaemia. Patients in the intervention group will be supplied with printed~     material with information on the disease and its management, mobile-telephone text messages~     with guideline summaries, reminders of forthcoming appointments and/or arrangements for~     making new appointments in the event of non-attendance, and self-report cards to check~     compliance with recommendations. Both groups -intervention and control- will receive routine~     recommendations from their physicians in accordance with current European clinical practice~     guidelines for hypercholesterolaemia and cardiovascular risk management. As regards the~     measurements to be made, the main variable is the proportion of subjects who attain the low~     density lipoprotein cholesterol levels set as a target across a follow-up period of 24~     months. The secondary variables are as follows: adherence to recommendations on lifestyle and~     adherence to drug treatment; variation in lipid profiles and cardiovascular risk levels;~     appearance of cardiovascular events; physical activity; food consumption; smoking habit;~     anthropometric measures; blood pressure; health problems; use of hypolipidaemic agents;~     socio-demographic data; beliefs and expectations about preventive recommendations; and degree~     of satisfaction with the combined strategy.~      Discussion Should this intervention prove effective, a recommendation could be issued on the~     application of this combined strategy to subjects with hypercholesterolaemia. It is a simple,~     relatively inexpensive intervention.~   "
95690|NCT02314650|"~     The study is aimed at whether transcutaneous electrical acupoint stimulation (TEAS) during~     general anesthesia could reduce the need for propofol in patients undergoing minor surgery.~   "
95691|NCT02314637|"~     The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) as~     monotherapy or in combination with Sulfonylurea (glimepiride) in Japanese patients with type~     2 Diabetes for 52 weeks administration.~   "
95717|NCT02314299|"~     This is a Phase 1/2, open-label, dose-escalation clinical study, enrolling 21 subjects in one~     of the two treatment groups to determine the effects of topical ocular administration of low~     dose or high dose MTP-131 given twice a day in subjects with Diabetic Macular Edema and~     Age-Related Macular Degeneration.~   "
96337|NCT02306174|"~     The purpose of this protocol is to investigate the effectiveness of a manualized, 20-week~     group cognitive rehabilitation (CR) and exposure therapy (ET) course for compulsive hoarding.~     The overarching aim is to understand whether this course will decrease the core symptoms of~     hoarding and associated features.~   "
95692|NCT02314624|"~     The ultimate goal is to facilitate the delivery of empirically supported treatments (ESTs)~     for mental disorders and to improve client mental health outcomes. Toward this end, this~     Phase II SBIR proposal seeks to complete the development and testing of PracticeGround, a~     comprehensive software system designed to integrate with electronic health records, and that~     contains multiple methods of training clinicians in ESTs and delivering ESTs to clients,~     continuous progress monitoring of client outcomes, and clinical support tools to guide~     clinicians and clients through delivery of the necessary EST. The investigators will conduct~     an 18-week randomized controlled trial (N=80) comparing PracticeGround (n=40) to~     care-as-usual (n=40) in depressed outpatient clients. PracticeGround clinicians will have~     full access to the software. Study clinicians and clients will be assessed once every six~     weeks (baseline, 6, 12, and 18 weeks). To ensure generalizability of findings, the~     investigators will not control for natural therapy variations (e.g.,session frequency,~     medication use, etc.). Primary outcomes include: depression, psychological distress,~     treatment satisfaction (clients and clinicians), and treatment drop out. Secondary clinician~     outcomes include: extent of PracticeGround use with clients across clinicians' caseload.~   "
95693|NCT02314611|"~     MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to~     evaluate the safety and efficacy of its total hip arthroplasty (THA) and resurfacing~     components marketed in the European Union (EU). These types of studies are required by~     regulatory authorities for all THA and resurfacing devices that do not have medium to~     long-term clinical evidence available at the time of gaining approval to market in the EU.~     This study has been designed in accordance with the medial device directives (MEDDEV) 2.12/2~     rev 2.~   "
95694|NCT02314598|"~     This is a prospective, non-randomized, multicenter, post market release study which will~     collect electrograms (EGMs) from patients at risk of a suspected insulation failure to the~     high voltage portion of the defibrillator lead and will evaluate the electrogram signals.~   "
95695|NCT02314585|"~     This study looks to see the effects of a home based exercise program on falls in people with~     MS.~   "
95696|NCT02314572|"~     The objective of this study is to assess the visual outcome after the combined binocular~     implantation of +2.5 D and +3.0 D apodized diffractive multifocal intraocular lenses.~   "
95697|NCT02314559|"~     Deep sedation with propofol for ambulatory colonoscopy has become standard clinical~     practice.To achieve the necessary (e.g.: no excessive movement and no awareness) level of~     sedation during colonoscopy, propofol can be titrated by hand, continuous infusion or by~     target controlled infusion.~      The aim of the investigators is to evaluate sedation efficacy and recovery between two groups~     of ambulatory patients having a colonoscopy: one group will receive a manual titration of~     propofol, the other group a target controlled infusion (TCI) of propofol. The investigators~     will evaluate both groups before, during and after colonoscopy for adverse events, quality of~     sedation and recovery. When patients are estimated to be ready for discharge, they will also~     be subjected to a cognitive and a psychomotoricity test.~   "
95698|NCT02314546|"~     The purpose of this study is to see if adding a numbing medicine, xylocaine, to the nasal~     midazolam makes giving the midazolam easier and more comfortable without affecting how the~     midazolam works as a sedative.~   "
95699|NCT02314533|"~     The investigators design this prospective, open-label, parallel, controlled study to~     investigate fenofibrate's effect on microalbuminuria reduction and serum creatinine on top of~     statin therapy in Chinese hypertriglyceridemic patients with type 2 diabetes.~   "
95700|NCT02314520|"~     The goal of this study is to determine whether Peripherally Inserted Central Catheter or~     Centrally Inserted Venous Catheters have lower complication rates in the Neuroscience~     Intensive Care Unit. After admission to the Neuroscience ICU and if they require central~     access, patients will be randomized to receive a PICC or CVC and complications (such as~     pneumothorax, deep venous thrombosis, infection, etc.) will be tracked and compared between~     the two interventions.~   "
95701|NCT02314507|"~     The purpose of the study is to investigate whether Gua sha is an effective modality for~     relieving chronic low back pain specifically in the aged population by comparing the baseline~     measures of pain intensity, self-perceived disability, back range of motion, back local~     muscle stiffness, depression, sleeping quality, quality of life, biomarkers measurement, and~     analgesic intake on days 1 and 7 after a single session of Gua sha treatment. In addition,~     the investigators are going to compare between Gua sha and hot pack treatments for the above~     parameters.~   "
95702|NCT02314494|"~     Children who are above healthy weight are more likely to be ill and to miss time off school.~     Being overweight in childhood can also sow the seeds for health problems in later life such~     as heart disease and diabetes. Most overweight children become overweight adults. One~     solution is to try to prevent children becoming overweight by intervening very early in life.~     The risk factors for childhood overweight are known and this project aims to facilitate~     parents' (and other carers') understanding about this for their infant and to enable them to~     access intervention. UK health visitors (public health nurses) will use an interactive,~     multimedia programme (Proactive Assessment of Overweight Risk during infancy (ProAsk)), with~     parents to calculate their infant's risk and to discuss strategies for risk reduction as~     appropriate. Health visitors will be trained to communicate obesity risk and in Motivational~     Interviewing techniques to enable them to offer intervention to parents of infants identified~     as at risk.~      A feasibility study of ProAsk will take place in two health provider organisations in the UK.~     The purpose of this is to a) determine the acceptability and utility of the ProAsk~     intervention with health visitors and parents and b) gather information to inform the trial~     design and data collection procedures for a future Randomised Controlled Trial (RCT).~   "
95731|NCT02314117|"~     The main purpose of this study is to evaluate the efficacy of ramucirumab, which is a~     targeted antibody, in combination with capecitabine and cisplatin compared to capecitabine~     and cisplatin alone in participants with stomach cancer.~   "
95746|NCT02313909|"~     This is a study in patients who recently had a brain attack (stroke) and in whom no clear~     cause of the stroke could be identified. These strokes are likely due to a blood clot and~     therefore, can be called embolic stroke of undetermined source. The abbreviation is ESUS. The~     study will compare 2 blood thinners. Patients will be randomly assigned to either Rivaroxaban~     15 mg or Aspirin 100 mg and the study is intended to show, if patients given rivaroxaban have~     fewer blood clots in the brain (stroke) or in other blood vessels.~   "
95703|NCT02314481|"~     DARWIN II is a multi-arm non-randomised phase II trial, Eligible patient will be those who~     relapse with NSCLC (clinical trials.gov ref. NCT02183883),~      The trial will investigate assess if intra-tumour heterogeneity (clonal vs subclonal~     actionable mutation) is associated with PFS.~      Patients 1) without an actionable mutation and PDL1 positive or 2) without an actionable~     mutation and PDL1 negative following first line cytotoxic chemotherapy, will receive~     MPDL3280A a monoclonal antibody targeting anti-PDL1.~      Patients with BRAFV600 mutations, Her2 Amplification, ALK/RET gene rearrangements will be~     enrolled into arms treating with vemurafenib, trastuzumab emtansine and alectinib~     respectively.~      DARWIN II will include extensive exploratory biomarker analysis to investigate a number of~     genomic and immune markers that may predict response to MPDL3280A and help guide future~     clinical trial design.~   "
95704|NCT02314468|"~     Introduction Necrotising soft tissue infections (NSTI) incorporate a spectrum of pathologies,~     all characterized by an infectious state, typically arising after a penetrating trauma or a~     surgical procedure and an expeditious spreading of necrosis throughout the soft tissues of~     the body. It is a rare, life-threatening and devastating infection defined by a necrosis of~     fascia, subcutaneous tissues and skin. Aggressive surgical debridement to remove all necrotic~     tissue and define the extent of the disease is still the mainstay of correct treatment of~     NSTI.~      Both negative pressure wound therapy (NPWT) and the application of allograft skin to debrided~     areas, are documented options for wound bed preparation which are standard in the university~     hospital of Gent.~      NPWT is a technique for wound bed preparation involving the controlled application of~     sub-atmospheric pressure to the local wound environment, using a sealed wound dressing~     connected to a vacuum pump. Mechanisms of action attributed to NPWT include an increase in~     blood flow, promotion of angiogenesis, reduction in wound surface area, positive modulation~     of the inhibitory contents of wound fluid, induction of cell proliferation, reduction of~     edema, and bacterial clearance.~      Allograft skin or cadaveric skin possesses many of the ideal properties of biologic~     dressings, and plays a major role in the surgical management of extensive wounds when~     autologous tissue may not be immediately available. It reduces evaporative water loss and the~     drainage of protein-rich fluids, prevents wound desiccation, and suppresses microbial~     proliferation. Wound pain is lessened and the allograft restores a physiologic barrier at the~     wound surface. Enhancing revascularization, and thereby creating a viable wound bed before~     final reconstruction, is perceived as one of the most important features of allografting.~   "
95705|NCT02314455|"~     To determine how the esophagus in active and inactive stages of eosinophilic esophagitis~     tranmit fluids.~   "
95706|NCT02314442|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and~     pharmacodynamics of ALN-PCSSC in subjects with elevated LDL-C.~   "
95707|NCT02314429|"~     In this first-in-human volunteer phase I clinical trial, a vaginal ring that slowly releases~     lactic acid (racemic mixture) into the vaginal environment, will be inserted in healthy~     volunteering women and left in place for 7 days. The primary objective of this phase I study~     is to assess the safety and the tolerability of this new intravaginal delivery system.~      The eventual goal of this and related studies is to develop a vaginal ring that reduces~     recurrences in women suffering from bacterial vaginosis, which is the commonest form of~     vaginal infection.~   "
95708|NCT02314416|"~     The purpose of the study is to use a collagen matrix embedded with amniotic stem cells to~     speed up the maturation and integration of the collagen matrix in the wound bed and shorten~     total time needed for wound healing.~   "
95709|NCT02314403|"~     This study will examine the safety and effectiveness of a combination kidney and bone marrow~     transplant from a haplo-identical related donor. An investigational medication and other~     treatments will be given prior to and after the transplant to help protect the transplanted~     kidney from being attacked by the body's immune system~   "
95710|NCT02314390|"~     The purpose of this study is to determine whether both group and individual mindfulness-based~     cognitive therapy (MBCT) are effective in reducing depressive symptoms in patients with a~     chronic somatic disease.~   "
95711|NCT02314377|"~     Bevacizumab Therapy for brain arteriovenous malformation that is not amenable to surgical~     intervention.~   "
95712|NCT02314364|"~     This research study is studying a type of radiation therapy called Stereotactic Body~     Radiation Therapy (SBRT) as a possible treatment for stage IV non-small cell lung cancer~     (NSCLC) that has a mutated epidermal growth factor receptor (EGFR) or or displaced anaplastic~     lymphoma receptor tyrosine kinase (ALK) or ROS proto-oncogene 1 (ROS1) gene (=~     oncogene-driven NSCLC) and for which the subject has been receiving treatment with a targeted~     biological agent such as erlotinib, crizotinib, or other drugs.~   "
95713|NCT02314351|"~     Migraine attacks were frequently diagnosed in the emergency departments. Also intravenous~     metoclopramide was a commonly used drug in the acute abortive treatment of migraine. However,~     the role of metoclopramide was based on three randomized, placebo-controlled studies, which~     were carried out with relatively few patients. Those trials suggested that metoclopramide~     produced larger improvements in visual analog scale (VAS) scores, however they revealed~     conflicting results and had significant methodological problems (risk of bias, allocation of~     concealment, intention-to-treat analysis). The investigators aimed to analyse the effects of~     intravenous metoclopramide in acute migraine attacks comparing with placebo.~   "
95714|NCT02314338|"~     Patients with COPD often have limitations to physical performance. There are several tests~     for evaluating physical performance, unfortunately many of them can be time consuming and~     require specialized equipment an substantial space. Short physical performance battery is a~     simple test that requires little resources and can be performed both at institutions and in~     the homes of patients. SPPB has high predictive abilities in identifying older adults at~     greater risk for mortality, nursing home admission, hospitalization, and incidence of~     disability. The investigators would like to evaluate possible changes in the SPPB score after~     a 4-week rehabilitation program. The investigators would also like to look at possible~     relationships between the SPPB and other physical performance measures, dyspnea, anxiety,~     depression, fatigue, and health related quality of life.~   "
95715|NCT02314325|"~     This trial is designed to assess if there is evidence of subclinical joint bleeding on~     MRI/X-Ray in adults with severe Haemophilia A while on standard and/or pharmacokinetically~     tailored prophylaxis regimens. Participants with severe Haemophilia A will have longitudinal~     MRI and XRay imaging of their elbows, ankles and knees at 0, 6 and 18 months while on~     standard ( 0-6 months) and then pharmacokinetically tailored (7-18 months) recombinant Factor~     VIII prophylaxis.~   "
95747|NCT02313896|"~     This is a 2 year research study to study if post discharge phone calls can help lengthen time~     to hospital readmissions for patients with encephalopathy.~   "
95718|NCT02314286|"~     Prospective randomized single blind trial. Study population are women diagnosed with severe~     pre-eclampsia during singleton pregnancy, between 24+0 weeks and 41+6 weeks gestational age.~     The purpose of the study is to evaluate the effect of Rosuvastatin on the severe preeclampsia~     resolution at 48 hours after delivery. After screening and signing an informed consent form,~     before entering delivery room, a randomization 1:1 will be carried. 50 women will be in the~     treatment arm while 50 will be in the control arm. Both groups will be treated according to~     ACOG (The American College of Obstetricians and Gynecologists has the following clinical~     guidelines related to deliveries before 39 weeks) guidelines. In addition, following~     randomization experimental group will be treated with Rosuvastatin 40mg that will be~     administrated orally with or without food. Treatment will be carried within the first hour~     following delivery. Another dose will be given 24 hours after first administration. Control~     group will be treated with placebo.~   "
95719|NCT02314273|"~     The goal of this clinical research study is to find out if rhIL-11（Interleukin 11） may~     increase the platelet count in Childhood patients with acute lymphocytic leukemia (ALL) who~     develop low platelet counts while receiving standard CAT（cyclophosphamide+Cytosine~     arabinoside+mercaptopurine，7d） therapy.~   "
95720|NCT02314260|"~     To have an early more precise way to predict failed induction in patients undergoing elective~     termination of pregnancy & those more likely to undergo caesarian section,this will Spare~     patients with decreased chances of favorable induction a long and exhausting trial of labour~     with increased probability of complications and an emergency caesarian~   "
95721|NCT02314247|"~     This is a single-arm, multi-center, open-label Phase II study of the SINE™ compound Selinexor~     given orally to patients with relapsed/refractory PTCL and CTCL.~      Approximately 60 patients with relapsed or refractory PTCL and CTCL who meet the eligibility~     criteria and have none of the exclusion criteria will be enrolled to receive Selinexor until~     either disease progression or intolerance has occurred.~   "
95722|NCT02314234|"~     To investigate the effectiveness of rapid reversal of rocuronium-induced neuromuscular block~     by sugammadex during IONM of facial nerve during parotid surgery~   "
95723|NCT02314221|"~     The primary objective of this study is to achieve successful walking skills using exoskeletal~     walking devices over the course of 36 sessions in 3 months at specific velocities and~     distances in people with chronic SCI who are wheelchair dependent for community mobility. The~     secondary objectives are to determine if this amount of exoskeletal walking is effective in~     improving bowel function and body composition in the same patient population. The exploratory~     objectives are to address additional questions concerning the retention or non-retention of~     the positive changes, the effects of the increased physical activity from this intervention~     on vagal tone, orthostatic tolerance, lipid profile, total testosterone, estradiol levels,~     and quality of life (QOL).~      A Phase III randomized clinical trial (RCT) will be performed using a crossover design and~     employing an exoskeletal-assisted walking intervention. The experimental arm will be compared~     to a usual activities (UA) arm, as the control, in 64 persons with chronic SCI (>6 month post~     injury) who are wheelchair-dependent for outdoor mobility in the community. The WALK arm will~     consist of supervised exoskeletal-assisted walking training, three sessions per week (4-6~     h/week) for 36 sessions for their second 12-week period. The UA arm will consist of~     identification of usual activities for each participant, encouragement to continue with these~     activities and attention by study team members throughout the 12-week UA arm. These~     activities will be recorded in a weekly log. The investigators hypotheses are that 1) this~     exoskeletal intervention will be successful in training ambulatory skills in this patient~     population, 2) the exoskeletal intervention will be better than a control group in improving~     body composition, bowel function, metabolic parameters and quality of life in the same~     population.~   "
95724|NCT02314208|"~     The purpose of this project is to study the efficacy of three candidate molecules (Xenbilox,~     Tahor and Resveratrol) in order to decrease the production of oxysterols by reducing the~     synthesis of cholesterol and/or regulate the production of bile acids and/or enabling~     neuroprotective action within the motor neuron.~   "
95725|NCT02314195|"~     Previous studies have highlighted the potential therapeutic benefits of receptive individual~     music therapy as an adjunct to standard care, in a variety of psychiatric ailments including~     mood and anxiety disorders. However, the role of music in the treatment of obsessive~     compulsive disorder have not been investigated to date. The present study therefore aimed to~     investigate the efficacy of music therapy as an adjunct to standard treatment, on obsessions~     in patients with treatment-naïve OCD. Moreover, given the fact that a significant proportion~     of patients with OCD have other comorbid mood or anxiety disorders, the question of whether~     therapeutic benefits of music could be expanded to also affect concurrent depressive and~     anxiety symptoms was explored.~   "
95726|NCT02314182|"~     A prospective, open, multicenter, randomized III trial with two arms:~        -  Arm A: Primary tumor resection , followed by chemotherapy~        -  Arm B: Chemotherapy alone. Compare overall 2-year survival rates in patients treated for~          resectable rectal adenocarcinoma with unresectable metastasis, treated either with the~          primary tumor resection with chemotherapy +/- target therapy, or with chemotherapy (+/-~          target therapy) alone.~   "
95727|NCT02314169|"~     This phase II trial studies how well nivolumab works in treating patients with anal canal~     cancer that has not responded to previous treatment (refractory) and has spread to other~     places in the body (metastatic). Monoclonal antibodies, such as nivolumab, may block tumor~     growth in different ways by targeting certain cells.~   "
95728|NCT02314156|"~     This randomized trial studies transdermal or oral telapristone acetate in treating patients~     undergoing surgery to remove the breast (mastectomy). Telapristone acetate may help prevent~     breast cancer from forming in premenopausal women. Giving telapristone acetate transdermally~     may be safer and have fewer side effects than oral administration.~   "
95729|NCT02314143|"~     This is a three-arm, open-label, randomised Phase II study to evaluate whether the different~     sequencing of dabrafenib and trametinib monotherapies and the upfront combination has an~     impact on translational or clinical activity in subjects with BRAF mutant metastatic~     unresectable stage IIIc or IV melanoma. Both dabrafenib and trametinib have demonstrated~     clinical activity as monotherapies and in combination in BRAF-mutant melanoma. However,~     duration of responses seem to be limited due to acquired drug resistance. The goal of this~     protocol is to study the sequential effects of BRAF and MEK inhibition on skin, blood and~     tumour biomarkers and to study the correlation between biomarkers and response to treatment~     and intrapatient toxicity. Approximately 54 eligible subjects will be randomised in the ratio~     of 1:1:1 to one of the three treatment arms.~   "
95730|NCT02314130|"~     The objective is to evaluate the effect of no-commercial enteral diet for patients in home~     nutritional therapy in anthropometric and biochemical indices comparing to patients using~     commercial enteral diets.~   "
95732|NCT02314104|"~     The purpose of this study is to determine if there is a better method of administering pain~     medication prior to minimally invasive gynecological surgery so that postoperative pain~     and/or narcotic usage may be minimized. Currently, no standard of care exists regarding the~     use of local pain medications in minimally invasive gynecological surgery and practices vary~     widely among physicians, even within the same institution.~      The two methods of preemptive pain medication that this study will be looking at is the~     transversus abdominis plane (TAP) block and the local injection of pain medication at the~     areas of the skin incisions. TAP block is a procedure performed by a specially trained pain~     management anesthesiologist in which there is an injection of a local pain medication into~     the abdominal wall, specifically in a space where the nerves that are responsible for~     postoperative pain reside. This procedure blocks the ability of the nerves to sense pain and~     has been found to be successful in decreasing postoperative pain in a number of procedures.~     The local injection of pain medications at the incision sites has also been found to be~     beneficial in decreasing postoperative pain. However, it is not known whether one method is~     superior to the other in decreasing postoperative pain or if the combination of both is best.~      Patients that chose to participate are randomly (by chance) assigned to one of three groups:~     1) TAP block with pain medication and local injection of normal saline (water) at the~     incision sites 2) TAP block with normal saline and local injection of pain medication at the~     incision sites or 3) TAP block with pain medication and local injection of pain medication at~     the port sites. These procedures are performed while the patient is asleep. Patients will be~     asked to record their level of pain on a standardized pain scale at one hour, six hours, and~     twenty-four hours after the surgery. All patients are provided with standard postoperative~     pain medications as needed.~      The hypothesis is that patients receiving both TAP block and local injection of pain~     medication at the port sites will have less pain postoperatively and require a smaller amount~     of narcotics than those that receive either the TAP block or local injection of pain~     medication alone.~   "
95733|NCT02314091|"~     Randomised prospective comparison of onlay and sublay mesh repair techniques in incisional~     hernia~   "
95734|NCT02314078|"~     A decision-to-delivery interval of 30 minutes for category-1 Caesarean section deliveries is~     the standard of practice recommended by clinical guidelines.~   "
95735|NCT02314065|"~     Background~      Severe health anxiety is a highly distressing, often debilitating, psychological problem.~     Since the release of the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) its~     clinical manifestations are increasingly often referred to as Somatic Symptom Disorder (SSD)~     or Illness Anxiety Disorder (IAD). Despite often being overlooked in routine care, several~     treatments for severe health anxiety have shown great promise, the most well-established~     being Cognitive Behavioral Therapy (CBT). Traditionally, CBT - like most other~     psychotherapies - has typically been delivered face-to-face. That is, the patient physically~     meeting with the therapist once a week for the whole of the treatment. Internet-delivered CBT~     does not rest on this requirement, but has nevertheless been shown to be efficacious for~     severe health anxiety (see for example NCT01673035).~      Aim of the study~      The present study aims to compare the effects of Internet-delivered CBT and CBT face-to-face~     for severe health anxiety in a randomized controlled trial. A non-inferiority criterion is~     applied to determine if Internet-delivered CBT is at least as efficacious as its~     well-established predecessor.~   "
95736|NCT02314052|"~     The purpose of this study is to assess the safety and tolerability of the investigational~     anticancer drug DCR-MYC. DCR-MYC is a novel synthetic double-stranded RNA in a stable lipid~     particle suspension that targets the oncogene MYC. MYC oncogene activation is important to~     the growth of many hematologic and solid tumor malignancies. In this study the Sponsor~     proposes to study DCR-MYC and its ability to inhibit MYC and thereby inhibit cancer cell~     growth.~   "
95737|NCT02314039|"~     This cross sectional questionnaire based study will aim at exploring psychological factors at~     play in the experience of acne, and their association with perceived and clinical severity.~     We will focus in particular on the role of psychological trauma in the patients with acne and~     their wellness. This project is being undertaken as part of a wider developing initiative in~     the Dermatology Department within NHS Tayside, which aims at identifying and consequently~     addressing the psychological needs of their patients. Participants will be consecutive~     patients with acne aged at least 18 years old, seen in the outpatient clinics of the~     Dermatology Department in NHS Tayside. Potential participants will be informed about the~     research by their clinician during an outpatients appointment and if interested, given an~     information sheet and consent form to review. Verbal consent will be sought by the clinician~     to give the potential participant's contact details to the Chief Investigator (CI)/Research~     Assistant (RA). If agreeable, the CI/RA will contact the potential participant after at least~     24 hours to arrange a mutually agreed time for meeting. If the potential participant are~     still keen to participate and has read the information sheet, fit our inclusion criteria, are~     not deemed to be distressed by their attending clinician and want to take part, they will be~     included. Participants will complete a number of standardised questionnaires and a~     demographics information sheet in the outpatients' clinic with the CI/RA present. The~     questionnaires include questions on psychological trauma history and symptomatology, general~     psychological distress, appearance related distress and perceived severity of condition.~     Clinical severity of their acne will be obtained from patient files after questionnaire~     completion by NHS staff. Participants will also be given a debrief letter and additional~     forms of support and information to take home with them. Participants will not be contacted~     for follow-up.~   "
95738|NCT02314026|"~     This study's aim is to develop an algorithm for the ¹³C-Octanoate Breath Test with or without~     the ¹³C-Methacetin Breath Test (OBT and MBT respectively) for correlation with histological~     findings associated with of Non-Alcoholic Steatohepatitis (NASH) and other liver diseases~     using the BreathID® System~   "
95739|NCT02314013|"~     The aim of the present study was to evaluate whether antibiotics is mandatory for the~     treatment of acute uncomplicated right-sided diverticulitis.~      The hypothesis is that patients having acute uncomplicated diverticulitis at right-sided~     colon will be recovered without antibiotics.~   "
95740|NCT02314000|"~     To demonstrate sustained clinically significant pain relief in patients with chronic pain~     when using the Boston Scientific Precision Spinal Cord Stimulator (SCS) System at~     sub‐perception amplitude~   "
95741|NCT02313987|"~     The current study is designed to test the hypothesis that compared to conventional treatment;~     endothelial function-guided treatment reduces adverse cardiovascular events in patients with~     non-obstructive coronary artery disease documented at clinically indicated coronary~     angiography.~   "
95742|NCT02313974|"~     At this moment, the duration of the treatment in Proliferative Lupus Nephritis has not been~     determined.~      Almost 30 percent of patients in total remission during or after a treatment, will relapse in~     the first 5 years.~      The factors associated to Renal relapses are not completly known. The investigators think~     that an histological control study performed to patient with complete remission for a year at~     the end of a 3 years treatment could help us to know which patients are going to relapse.~   "
95743|NCT02313961|"~     The primary objective of the RIC-STEMI trial is to assess whether remote ischaemic~     conditioning (RIC) as an adjunctive therapy during primary percutaneous coronary intervention~     (PCI) in patients presenting with ST-elevation myocardial infarction (STEMI) can improve~     clinical outcomes as assessed by death from cardiac-cause or hospitalization for heart~     failure (HF) for a minimum follow-up period of 12 months.~   "
95744|NCT02313935|"~     The study involved Information and Communication Technologies (ICT) and more specifically~     computer exercises blended with game activities. It was hypothesized that ICT facilitated,~     game blended cognitive and/or physical exercise improves global cognition when compared to~     control groups; moreover, these improvements may be manifested by brain activity changes; we~     explored the impact of potential moderators on combined exercise-induced cognitive benefits,~     as well as, individual/separate training schemes.~   "
95749|NCT02313870|"~     This controlled multi-center randomized clinical trial, with direct individual benefit, will~     compare efficacy and safety of two strategies in non-localized BP care: a combined regimen~     using initial superpotent topical steroids associated with methotrexate for 4 weeks followed~     by methotrexate alone for 8 months and superpotent topical steroids alone maintained 9 months~     (current standard of care). The expected result is an equivalence between the two compared~     strategies in terms of safety and efficacy, MTX monotherapy during the maintenance phase~     being easier to manage and therefore associated with better compliance than topical steroids~     with less cutaneous side effects and most cost-effective.~   "
95750|NCT02313857|"~     Patients enrolled on this study will have received a stem cell transplant. After a~     transplant, while the immune system grows back the patient is at risk for infection. Some~     viruses can stay in the body for life, and if the immune system is weakened (like after a~     transplant), they can cause life-threatening infections.~      CMV can cause serious infections in patients with weak or suppressed immune systems. It~     usually affects the lungs, causing a very serious pneumonia, but it can also affect the gut,~     the liver and the eyes.~      Investigators want to see if they can use a kind of white blood cell called T cells to treat~     CMV infections that occur after a transplant. Investigators have observed in other studies~     that treatment with specially trained T cells has been successful when the cells are made~     from the transplant donor. However as it takes 1-2 months to make the cells, that approach is~     not practical when a patient already has an infection.~      Investigators have now generated CMV-specific T cells from the blood of healthy donors and~     created a bank of these cells. Investigators have previously successfully used frozen~     virus-specific T cell lines generated from healthy donors to treat virus infections after~     bone marrow transplant, and have now improved the production method and customized the bank~     of lines to specifically and exclusively target CMV.~      In this study, investigators want to find out if the banked CMV-specific T cells derived from~     healthy donors are safe and can help to treat CMV infection.~      The CMV-specific T cells (Viralym-C) are an investigational product not approved by the Food~     and Drug Administration (FDA).~   "
95751|NCT02313844|"~     Patients enrolled on this study will have received a stem cell transplant. After a~     transplant, while the immune system grows back the patient is at risk for infection. Some~     viruses can stay in the body for life, and if the immune system is weakened (like after a~     transplant), they can cause life-threatening infections.~      BK virus (BKV) is a virus that can cause serious life-threatening infections in patients who~     have weak immune systems. It affects the urinary tract, and can cause frequent urination,~     blood in the urine, and severe pain.~      Investigators want to see if they can use a kind of white blood cell called T cells to treat~     BKV infections that occur after a transplant. Investigators have observed in other studies~     that treatment with specially trained T cells has been successful when the cells are made~     from the transplant donor. However as it takes 1-2 months to make the cells, that approach is~     not practical when a patient already has an infection.~      Investigators have now generated BKV-specific T cells from the blood of healthy donors and~     created a bank of these cells. Investigators have previously successfully used frozen~     virus-specific T cell lines generated from healthy donors to treat virus infections after~     bone marrow transplant, and have now improved the production method and customized the bank~     of lines to specifically and exclusively target BKV.~      In this study, investigators want to find out if the banked BKV-specific T cells derived from~     healthy donors are safe and can help to treat BK virus infection.~      The BKV-specific T cells (Viralym-B) are an investigational product not approved by the Food~     and Drug Administration (FDA).~   "
95752|NCT02313831|"~     The purpose of this study is to investigate the effects of interval training, based-intensity~     on 70% at 110% of oxygen consumption and workload attained on ventilatory anaerobic~     threshold, on aerobic functional capacity, autonomic modulation of heart rate, metabolic~     profile in patients with and without coronary artery disease.~   "
95753|NCT02313818|"~     The primary goal of this study is to improve the overall efficacy of cognitive processing~     therapy-cognitive-only version (CPT-C) in a sample of 130 active-duty service members through~     a variable length treatment.~   "
95754|NCT02313805|"~     Diabetes prevalence continues to rise worldwide, leading to the increasing use of insulin.~     This especially applies to developing countries where the needle-and-syringe method of~     administration remains the most affordable and effective form of hyperglycemic treatment.~     Competent health care professionals are required to ensure safe insulin initiation. The~     investigators will evaluate a teaching intervention on insulin initiation for medical~     students, and whether after experiencing that intervention the use of a checklist, during~     simulate insulin initiation, improves the education they provide to patients.~   "
95755|NCT02313792|"~     The purpose of this study is to compare the efficacy and safety of palifermin on reducing~     mucositis for patients receiving autologous or allogeneic stem cell transplantation with~     supportive care.~   "
95756|NCT02313779|"~     The overarching goal of the proposed research is to investigate the role of emotions in~     facilitating successful lifestyle change, defined as healthy behavioral decisions repeated~     daily, or near daily.~      Participants are asked to make two lab visits during the course of four weeks to complete~     electronic questionnaires, be monitored for psychophysiological activity (e.g. heart rate,~     blood pressure, respiration), and listen to a guided meditation audio track. Additionally,~     between the two visits participants will be asked to complete weekly surveys that ask about~     daily meditation practice (outside of the lab) and general emotions.~   "
95757|NCT02313766|"~     Adults patients scheduled for elective surgery were randomly allocated to receive~     preoxygenation with spontaneous breathing, positive pressure ventilation (positive~     inspiratory pressure: 12 cmH2O) without PEEP, and with PEEP (positive inspiratory pressure:~     12 cmH2O, PEEP: 6 cmH2O). Preoxygenation time was measured from face mask positioning to~     FEO2=90% (FEO2 : expired fraction of O2). After endotracheal tube placement the time until~     SpO2=93% (SpO2 : peripheral oxygen saturation) was measured during monitored apnoea.~     Patient's discomfort was recorded (visual analogue scale).~   "
95758|NCT02313753|"~     The purpose of this study is to evaluate the utility of the Coping Long Term with Active~     Suicide Program (CLASP) for reducing suicidal behavior.~   "
96398|NCT02305381|"~     This trial is conducted in Asia, Europe and the United States of America (USA). The aim of~     the trial is to investigate efficacy and safety of semaglutide once weekly versus placebo as~     add-on to basal insulin alone or basal insulin in combination with metformin in subjects with~     type 2 diabetes.~   "
95759|NCT02313740|"~     Prospective cohort study to evaluate safety and immunogenicity of the fragmented, inactivated~     trivalent Influenza vaccine produced at Butantan Institute in healthy adults and elderly. The~     study will include a total of 120 participants: 60 participants aged 18 to 59 years in the~     healthy adults group, and 60 participants aged older than 60 years in the elderly group.This~     study will evaluate the safety of one dose of the fragmented, inactivated trivalent Influenza~     vaccine in the first 3 days after vaccination, as well as its immunogenicity 21 days after~     vaccination.~   "
95760|NCT02313727|"~     It will be a pilot, 2 year, prospective, randomized, double-blind, placebo-controlled (for~     pamidronate) study. All patients with AS will receive treatment with TNF inhibitor, while~     randomization will be performed for pamidronate versus placebo group. Primary outcome will be~     the rate of radiographic progression of AS, calculated after 24 months of combined treatment.~   "
95761|NCT02313714|"~     This study intends to treat patient with congestive heart failure that are maximized their~     pharmacological treatment and at heart transplant wait list.~      All patients in the treatment arm will receive electric muscular stimulation with a Russian~     current protocol twice a week for 7 weeks.~      The outcome will be assessed by the improvement in quality of life and functional capacity.~   "
95762|NCT02313701|"~     The investigators aim is to augment the current process for surgical consent for patients~     undergoing urogynecological procedures by incorporating visual media. We propose that visual~     media will be an effective and efficient addition to the standard of care in urogynecological~     consents and will improve patient understanding and satisfaction. Our randomized controlled~     trial will investigate the effect of standardizing the consent for three urogynecologic~     procedures (vaginal hysterectomy, robotic sacrocolpopexy, and sub-urethral sling) using~     visual media, on patients' understanding of, and satisfaction with, their procedure. Our~     primary outcome will be patient's knowledge score at the end of the pre-operative clinic~     visit, and secondary outcomes include patients' satisfaction, subjective understanding of~     their procedure, immediate pre-operative and post-operative knowledge, and number of~     post-operative encounters. Participants will be followed up to their post-operative clinic~     visit.~   "
95763|NCT02313688|"~     The incidence of adenocarcinomas of the esophagogastric junction (AEJ) has increased rapidly~     during the past decades. By the Siewert classification, the AEJ is the tumor center located 5~     cm above the anatomic cardia and 5 cm below it, which is divided into three individual~     subtypes. Complete tumor resection is the primary therapy strategies for tumors of the AEJ.~     The Japan Clinical Oncology Group 9502 (JCOG 9502) found that transabdominal or transhiatal~     approach gastrectomy has better survival outcomes compared with left thoracoabdominal~     approach surgery for Siewert II/III tumors. Transabdominal approach gastrectomy is~     recommended as the standard treatment strategy for Siewert II/III tumors by the guidelines of~     the Japanese Gastric Cancer Association (JGCA). However, the length of the proximal resection~     margin for Siewert-II/III tumors by transabdominal/transhiatal gastrectomy is still~     controversies. Previous study found that longer than 2cm proximal resection margin had better~     survival outcome than less than 2cm proximal resection margin for Siewert-II/III tumors. On~     the other sides, due to more advanced tumor stage of patients in China when compared with~     Japan and Korea. It is necessary to conduct a randomized control study to analyze the length~     of resection margin in advanced adenocarcinomas of esophagogastric junction.~      Therefore, this study was aimed to include those Siewert II/III tumor patients in~     Gastrointestinal Surgery Department, West China Hospital, Sichuan University to analyze the~     relationship between the length of proximal resection margin and survival outcomes.~   "
95764|NCT02313675|"~     The purpose of this study is to determine the efficacy of intra-operative administration of~     IV tylenol and/or IV toradol in minimizing post-operative pain for carpal tunnel patients and~     distal radius fracture patients.~   "
95765|NCT02313662|"~     All patients planned for PDD guided TURB can be included in this study. Two different optics~     with PDD and NBI are applied to the resectoscope in addition to regular WL.~      First, a WL cystoscopy is made and any suspect areas are noted on the registration form, then~     NBI is used and any suspect areas are noted and finally the cystoscopy is made with PDD with~     registration of any additional findings. To adjust for bias introduced by photo bleaching,~     the second part of the study will be performed with PDD as the second modality. Any flat~     lesions will be biopsied if they appear suspicious in one of the modalities.~      The registration form is completed by the surgeon, once the pathology results are known.~      A total number of 152 patients is planned to be included.~   "
95766|NCT02313649|"~     This study will evaluate how liver stiffness measurements made with ShearWave™ Elastography~     (SWE) correspond with a biopsy result (currently the gold standard). The population that will~     be evaluated are Chinese patients infected with the Hepatitis B virus.~   "
95767|NCT02313636|"~     Patients with first time hematuria or patients previously diagnosed with papillomas/CIS of~     the bladder are included in the study. All surgeons are highly experienced in WL cystoscopy~     and familiar with NBI findings. Cystoscopy is performed with HD cameras and Olympus light~     sources.~      First, a systematic cystoscopy is made in WL. Secondly, the clinical decision is noted. After~     WL, the cystoscopy is made with NBI and any potential subsequent change in the clinical~     decision is noted.~      A total number of 896 patients is planned to be included.~   "
95768|NCT02313623|"~     The investigators hypothesize that this single-cell analysis can be used to evaluate prostate~     needle-core biopsies prospectively even in non-homogenous samples by providing profiles of~     proteomic and phenotypic signatures. These profiles will in turn enable better predictions of~     the malignant progression of prostate cancers in the settings of current clinical practice.~   "
95769|NCT02313610|"~     The purpose of this study is to assess the efficacy and safety of Chinese medicine Qinbudan~     in Patients Receiving Standard Combination Therapy for Retreatment Pulmonary Tuberculosis.~   "
95796|NCT02313246|"~     This study evaluates the effectiveness of a group cognitive behaviour therapy for Irritable~     Bowel Syndrome (IBS) in decreasing symptoms of IBS, improving quality of life, and~     normalizing the gut microbiome. Patients will complete an 11-week group cognitive behaviour~     therapy for IBS within 1 month of being deemed eligible for the study.~   "
95797|NCT02313233|"~     To evaluate the improvement in symptoms of Benign Prostatic Hyperplasia (BPH) according to~     the Prostate Symptom Score (IPSS) and Quality- of- Life (QoL) index after add- on therapy of~     Umooze twice daily administration for 56 days in patients with BPH.~   "
95770|NCT02313597|"~     Anal fistula is the most common Peri anal disease. It's a disease with an incidence of 9 in~     100,000. Anal fistula is classified on the basis of its location into high and low anal~     fistula, above or below dentate line respectively.~      Multiple series have shown that the formation of a fistula tract following anorectal abscess~     occurs in 7-40% of cases. There are typically 8-10 anal crypt glands at the level of the~     dentate line in the anal canal arranged circumstantially. These glands afford a path for~     infecting organisms to reach the intramuscular spaces. The cryptoglandular hypothesis states~     that an infection begins in the anal canal glands and progresses into the muscular wall of~     the anal sphincters to cause an anorectal abscess.~      According to internal opening many author proposed certain classification but the~     standardized in all of them is Park's classification, so this study categorized the patient~     through this classification. There are four types of fistula-in-ano in Park's Classification~     intersphincteric (between internal and external sphincters is 70%), transsphincteric (across~     external sphincters is 25%), suprasphincteric (over sphincters), and extrasphincteric(above~     and through levator ani).High anal fistula is considered to be difficult to treat because of~     its location.This study diagnosed the internal opening of high perianal with the help of~     endoluminal ultrasound and MRI.~      Classic method of its treatment are fistulotomy, fistulectomy and Setone placement but these~     are associated with lots of complication like fecal incontinence,recurrence,pain.Therefore~     many method have been recently devised including Ligation of intersphincteric fistula tract~     (Lift), glue repair and flap advancement.Another recently introduced method for its treatment~     is Video-assisted anal fistula treatment (VAAFT) proposed by P. Meinero which has been~     associated with less complications.~   "
95771|NCT02313584|"~     The purpose of this study is to investigate the appropriate duration of dabigatran use after~     radiofrequency catheter ablation for paroxysmal atrial fibrillation in patients with low~     thromboembolic risk. According to the most recent guideline, anticoagulation is recommended~     to continue at least 2 months after the procedure. However bleeding risk with anticoagulant~     is also problematic. Post-procedural thrombosis is considered due to acute inflammation or~     char formation at the site of ablation, and these reaction occurs mostly within 1 month after~     the procedure. Also, the risk of thromboembolism is low in patients with CHA2DS2-VASc score~     less than 1. The investigators hypothesized that dabigatran use for the first 1 month after~     the RFCA for patients with paroxysmal AF and low thromboembolic risk would be sufficient for~     efficacy and safety compared to conventional dabigatran use for 2 months.~   "
95772|NCT02313571|"~     The computer-integrated patient controlled epidural analgesia (CIPCEA) system can~     automatically adjust the background infusion rate during combined spinal-epidural (CSE)~     analgesia based on the parturient's need as labour progresses. Analysis of parturients~     experiencing breakthrough pain may identify associated factors that can also be related to~     obstetric or foetal outcomes~   "
95773|NCT02313558|"~     The objective of the present study was to compare the anti-plaque and anti-gingivitis effects~     of a commercially available dentifrice containing 0.6% Ilicis Rotundae Cortex extract to~     those of a control dentifrice without any active ingredient in 12 weeks of home use.~   "
95774|NCT02313545|"~     In this open label study, 50 eligible women will be assigned to receive the investigational~     product (IZN-6NVS) - 2.5 g of cream/day for 14 days, followed by 3 applications per week for~     the next 4 weeks. Clinical assessment of the severity of vaginitis will be performed at~     baseline and after 2 and 6 weeks of treatment.~      The study will evaluate safety, tolerability and efficacy of IZN-6NVS vaginal cream, in the~     treatment of atrophic vaginitis (AV) and desquamative inflammatory vaginitis (DIV).~   "
95775|NCT02313532|"~     Study goal - to describe pediatric patients with febrile disease that administered to the~     emergency department (ED) of hillel-yaffe hospital, according to arrival diagnosis, ED~     diagnosis, given therapy, and therapy concordance with the guidelines and final diagnosis.~      This research will describe cases that arrived to the hospital with acute febrile disease (up~     to seven days of fever), the antibiotic treatment given in the community according to the~     anamnesis and the community physician letter, therapy concordance with the guidelines, the ED~     diagnosis and changes in therapy, and final diagnosis according to extended microbiological~     examinations and panel of infectious disease specialists.~   "
95776|NCT02313519|"~     Based on the need of large-scale, trials to explore the use of probiotics to reduce~     post-operative complication rate, a randomized controlled trial is designed to investigate~     the impact of a probiotics treatment protocol on postoperative morbidity in an open elective~     colonic surgery cohort. The major objective is reduction of post-operative complications~     after 30 days.~   "
95777|NCT02313506|"~     Physical activity is an essential first-line treatment for patients with knee osteoarthritis~     (OA). However, a 2013 systematic review found only 13% met the activity recommendation of 150~     minutes or more per week. The primary goal of this pilot randomized controlled trail is to~     assess the feasibility and preliminary efficacy of a multi-component intervention/model of~     care involving a group education session, use of the Fitbit Flex (a wireless physical~     activity tracking device), and weekly telephone counselling by a physiotherapist (PT) to~     improve physical activity and reduce sedentary time in patients with knee OA.~   "
95778|NCT02313493|"~     In the present pilot study the feasibility and efficacy of Baby Triple P- an antenatal parent~     training- are investigated. Healthy becoming first time parents were randomly allocated to~     either the Baby Triple P parent-training group or a care as usual control group. It is~     expected that 78 couples of becoming first time parents are recruited. It is hypothesized~     that parents and their infants in the parent training group will show significantly less~     psychopathology / regulation problems and better partnership quality than participants in the~     control condition.~   "
95779|NCT02313480|"~     To date, the benefits of massage in chronic neck pain patients has only been investigated as~     a singular treatment, rather than as part of a treatment package. The need for this research~     has been highlighted in the literature (Ezzo et al, 2007; Haraldsson et al, 2006) This~     research aimed to establish whether the addition of massage to a program of exercise and~     manual therapy offers any additional benefits over exercise and manual therapy alone in the~     treatment of patients with chronic neck pain.~   "
95780|NCT02313467|"~     In this study, the investigators are going to compare the clinical effect and safety of~     topical application of 1.5% Butenyl ALA cream formula without light source irradiation in the~     treatment of acne.~   "
95781|NCT02313441|"~     Myocyte necrosis occurs frequently in elective percutanious percutaneous coronary~     intervention (PCI) and is associated with subsequent cardiovascular events. This study~     assessed the cardio- and reno-protective effect of remote ischemic preconditioning (RIPC) in~     patients undergoing elective PCI. 200 patients were randomized into 2 groups: 100 patients~     received RIPC (created by three 5-minute inflations of a blood pressure cuff to 200 mm Hg~     around the upper arm, separated by 5-minute intervals of reperfusion) < 2 hours before the~     PCI procedure, and the control group (n = 100).~   "
95782|NCT02313428|"~     This study is to observe the effect of application of topically administered oxygen on~     healing rate, cost of care and rate of amputations in diabetic patients with chronic~     wounds(s) . The proposed study is a pragmatic (comparative effectiveness research, CER)~     study, in which the effectiveness of topical oxygen (100%) administered 4 days per week, for~     16 weeks, for the treatment of diabetic wound(s) will be measure and compared with standard~     of care (SoC) treatment. There will be a 2 patient groups (including a comparison group and a~     treatment group) including: (1) Patients will only receive standard treatment (2) Patients~     will receive standard treatment plus Topical Oxygen Therapy (TOT). All of the Topical Oxygen~     Therapy will be provided in a home care setting or extended care facility. 140 patients will~     be recruited.~      There are two arms of the study. Arm 1 will enroll 100 subjects to assist the Ohio Department~     of Medicaid (ODM) and to provide efficient and effective administration of the Medicaid~     program. This is an observational and descriptive study that will seek to generate a~     hypothesis. Due to the small sample size this study will primarily be a feasibility study~     that will attempt to measure and evaluate differences in the relative costs of the~     intervention of topical oxygen therapy on this population and subsequently compare outcomes~     in areas such as overall health improvements and cost effectiveness. The patient population~     will consist of Medicaid beneficiaries with chronic wounds and below who are enrolled in the~     United Health Care Community Plan of Ohio (UHC).~      Arm 2 of the study will enroll 40 additional patients that are Medicare and Dual~     Medicare/Medicaid recipients with chronic wounds.~   "
95783|NCT02313415|"~     Study of the treatment of infertility caused by recurrent intrauterine adhesions (IUA) by~     collagen scaffold loaded with umbilical cord derived mesenchymal stem cells (UC-MSCs) to~     provide clinical evidence of safety and effectiveness for the treatment of uterine~     infertility.~   "
95784|NCT02313402|"~     Eighteen ALS patients will be trained to control a new communication device (Eye On Line:~     EOL) that permit over smooth eye movements to generate digits, letters, words or drawing at~     will. The intervention consists in a training program during six visits over 3 weeks on site~     allowing a gradual acquisition of the eye-writing. The primary objective of the study is to~     assess the feasibility of the use of EOL device in ALS patients. The EOL device potentially~     offers a creative and personal means of linguistic and emotional expression in subject with~     motor disability.~   "
95785|NCT02313389|"~     Hypothesis~      Our hypothesis is that maintenance chemotherapy will prolong complete remission obtained~     after a standard induction chemotherapy with an acceptable toxicity in the elderly.~      Rationale~        -  Treatment of the elderly is challenging, indeed age over 60 is associated both with a~          poor prognosis and a high risk of treatment induced neurotoxicity with devastating~          consequences on quality of life. Therefore it has become standard practice to treat~          elderly in first line with high-dose methotrexate (MTX) based polychemotherapy alone,~          avoiding whole brain radiotherapy (WBRT) or deferring it for recurrence.~        -  There is a clear need to improve disease control after induction chemotherapy. Since~          consolidation with WBRT or intensive chemotherapy with autologous stem cell rescue are~          either poorly effective and/or too toxic in the elderly population, maintenance~          chemotherapy is an interesting alternative approach. Several agents, such as high-dose~          MTX, temozolomide (TMZ), rituximab, with a reported activity in PCNSL and acceptable~          safety profile, as single agent or combined, are good candidates for maintenance~   "
95786|NCT02313376|"~     Study designed to evaluate safety and tolerability of a genetically attenuated P. falciparum~     (GAP3KO) that arrests early in the liver stage of the parasite life cycle. Study will also~     confirm the attenuation of the GAP3KO parasites using peripheral blood smears. Secondary~     objectives are to evaluate the humoral immune responses to GAP3KO.~   "
95787|NCT02313363|"~     The investigators developed a patient-centered smartphone-based diabetes care system (PSDCS).~     This study was aimed to test the feasibility of the PSDCS.~   "
95788|NCT02313350|"~     Sciatica due to herniated disc is a major cause of disability in young adults. Surgery is the~     gold-standard and the only controlled treatment in case of failure of conservative treatment.~      Percutaneous chemonucleolysis with Discogel® may be a valuable alternative to surgery.~      In addition, Discogel® chemonucleolysis appears as a relatively innocuous technique which may~     avoid 2% complications after disc surgery and 5% repeated surgery (according to recent~     trials).~      This will be the first randomized trial comparing Discogel® chemonucleolysis versus surgery~     in patients with sciatica due to lumbar disc herniation and unresponsive to conservative~     medical treatments (including epidural steroid injections) Our expectation is that Discogel®~     chemonucleolysis will avoid surgery in 80% of the patients.~   "
95789|NCT02313337|"~     The study purpose is to compare the effect of different Administration Routes of Pediatric~     Premedication (including oral administration, intramuscular injection, rectal perfusion,~     intranasal).~   "
95790|NCT02313324|"~     The purpose of this study is to evaluate the effects of extracorporeal shock wave therapy~     (ESWT) on the outcomes of coccydynia.~   "
95791|NCT02313311|"~     The objective of this study is to establish a hierarchical embryo selection process by using~     the time-lapse imaging (TLI), combining the embryo cleavage patterns and timing parameters.~   "
95792|NCT02313298|"~     A single arm phase II study of SBRT for prostate cancer to primarily assess acute and late~     toxicity and secondarily PSA outcomes and quality of life measurements of an extreme~     hypofractionated regimen of 36.25Gy in 5 fractions over 10-11 days.~   "
95793|NCT02313285|"~     Primary Objective:~      To assess the long-term safety of GZ402668 in patients with multiple sclerosis (MS) who~     received prior treatment during the TDU13475 or TDU14981 studies.~      Secondary Objectives:~      To assess the pharmacokinetics of GZ402668 in patients with MS. To assess the~     pharmacodynamics of GZ402668 in patients with MS. To assess the immunogenicity of GZ402668 in~     patients with MS.~   "
95794|NCT02313272|"~     The purpose of this study is to see if the addition of the investigation drug called~     pembrolizumab (Keytruda®) to radiation therapy and bevacizumab (Avastin®) is safe and can~     help with controlling the growth of tumors, in participants with recurrent high grade glioma.~   "
95808|NCT02313090|"~     The aim was to assess the impact of a cell phone-based diabetes management application~     (Welltang) on HbA1c, blood glucose, lipids, physical activity, weight, and blood pressure~     during 3 months. And hypoglycemic events, the satisfaction of the patients with Boyibang,~     their diabetes knowledge and self-care behaviors were also evaluated.~   "
95798|NCT02313220|"~     Obesity is a medical condition which increases the risk of other diseases, such as type 2~     diabetes and cardiovascular disease. Obesity-related risk factors for the development of~     other metabolic diseases include unstable glucose levels and high blood pressure.~     Dapagliflozin and exenatide are both approved worldwide for treatment of patients with Type 2~     Diabetes. Dapagliflozin works by lowering glucose levels by inhibiting the renal reabsorption~     of glucose and thereby promoting its urinary excretion and energy loss and thereby reduction~     in body fat. Exenatide exhibits many of the same glucose-lowering actions of that of a~     naturally occurring hormone and leads to weight loss mainly via reduced energy intake, most~     likely via a central effect on appetite regulation. The purpose of this exploratory study is~     to investigate if a combination treatment with dapagliflozin and exenatide have a synergistic~     effect on weight loss in non-diabetic obese subjects. Subjects will be treated for 24 weeks~     with either active combination treatment or placebo (non-active treatment). Neither study~     personnel nor subjects will know what treatment is given. All subjects completing the 24-week~     double-blind study and who are willing and eligible will be offered to enter a 28-week~     open-label extension study. All subjects entering the extension study will receive unblinded~     active study treatment for an additional 28 weeks. Thus the total treatment period for~     subjects entering the extension study will be 52 weeks.~   "
95799|NCT02313207|"~     This study will assess dynamic effects of two major antigens on the duodenal mucosa by~     confocal laser endomicroscopy (CLE). Patients will be blinded to the antigens used (wheat,~     yeast). Following CLE it is planned to have a cross over exclusion diet with/without the~     antigens including a washout phase. Furthermore, patients will undergo a 2 week FODMAP diet~     to be able to compare results found of both diets and allow to understand whether our~     findings of food intolerance will be better and more precise than a common FODMAP diet.~      Post CLE food challenge patients biopsies will be taken for histology. They will then be~     randomized into two groups and blinded to the diet they undergo. They will be provided with a~     supply of custom-made bread they will have for 2 weeks (custom made by a bakery in Kiel). For~     one study arm bread will contain either wheat and yeast, for the other arm the bread will not~     contain these ingredients. The taste of the normal bread will be denaturised. Crossover~     will take place after a two-week washout phase.~   "
95800|NCT02313194|"~     This study is designed to assess the strategy of using spinal cord stimulation to improve the~     ability to move in spinal cord injured humans.~   "
95801|NCT02313181|"~     This is a randomized, controlled trial designed to evaluate a new strategy for promoting~     continued breastfeeding for mothers and babies who initiated breastfeeding in the newborn~     period. The new strategy, called Early Limited Formula (ELF), consists of 10mL of formula fed~     to each baby by syringe after each breastfeeding prior to the onset of mature milk~     production. The study intervention is discontinued at the onset of mature milk production,~     and the investigators will then follow mothers and infants for 12 months to assess the effect~     of ELF on breastfeeding duration, maternal experience and healthcare utilization.~   "
95802|NCT02313168|"~     The F.R.O.N.T. formula for pre-operative airway assessment and documentation~      Background:~      Prediction of difficult airway is one of the most important challenges before general~     anesthesia. Although in recent decades different scoring systems have been for the~     preoperative assessment of their sensitivity and specificity in predicting a difficult airway~     remains moderate. Recently, the calculation of composite scores using different formulae has~     been proposed as the most sensitive one. The aim of the present work was to test the clinical~     usefulness of the FRONT score, a recently developed scoring system.~      Methods:~      This study was a multi-center, inter-observer, prospective and double-blind investigation~     that included 976 patients from two university centers: 250 from the University of~     Cluj-Napoca, Romania, and 726 from the University of Debrecen, Hungary.~      The preoperative evaluation of the patients was performed by a preoperative team of~     anesthesiologists (team A) who evaluated and scored the expected difficulty of the management~     of the airway. An intraoperative team of evaluators (team B) working independently from team~     A, performed the actual instrumentation of the airway and scored the actual findings. Both~     teams used the FRONT scoring system and worked independently from each other to ensure~     blinded assessment. Statistical analysis of the preoperative and intraoperative FRONT scores~     were performed post hoc.~   "
95803|NCT02313155|"~     The purpose of this study is to evaluate the safety and immunogenicity of a single~     subcutaneous injection of TAK-850 as compared to intramuscular injection of TAK-850 in~     healthy Japanese adults~   "
95804|NCT02313142|"~     One of the major issues in space explorations is the negative effect of prolonged exposure to~     very low gravity (i.e. a condition often referred to as microgravity or weightlessness) on~     astronauts' health. In this unusual condition the human body undergoes an adaptation process,~     often referred to as deconditioning, that leads to significant loss of bone and muscle~     mass, hormonal changes, as well as modifications of important cardiovascular parameters.~     While the new physiological state is adequate to the microgravity environment, it results~     unsuitable upon return on earth. Hence after the mission astronauts experience various~     health-related problems and must undertake an intense rehabilitation program. Cardiovascular~     deconditioning originates mainly from a shift of blood from the lower extremities to the~     upper part of the body caused by the absence of gravity. In the long term (i.e. days) this~     causes a loss of blood and body fluid. In the short term (i.e. minutes) it elicits~     modifications to arterial blood pressure and heart rate.~      In this study, funded by the European Union through the project STAMAS, we intend to evaluate~     whether leg physical exercises can lead to a displacement of blood towards the lower~     extremities, therefore ameliorating the upward fluid shift caused by weightlessness. More~     generally, we aim to investigate the short-term response of the cardiovascular system to leg~     exercises in microgravity-like conditions. After a clear understanding of these phenomena we~     will develop a controller that, by monitoring the physiological stare of a subject, will~     compute the appropriate exercise regime to stabilize his/her cardiovascular parameters to~     desired safe values. Our contribution will provide a better understanding of the~     cardiovascular system, and will delineate the physiological ground for the development of~     novel countermeasure devices against the cardiovascular deconditioning during space flight~     based on continuous leg exercises.~      The protocol we propose in this document presents minimal risks for our potential subjects,~     while has the potential to produce important contributions. The cardiovascular parameters we~     intend to analyse are: blood pressure, heart rate and leg blood volume. These signals will be~     acquired non-invasively and with minimal risks. Leg exercises will be performed by means of a~     stepping device (MARCOS) previously developed in our Lab. MARCOS enables to vary the~     resistance applied against knee-extension movements, and therefore it allows a systematic~     evaluation of different exercise intensities. Finally, microgravity conditions can be easily~     emulated by letting the subjects lay on a tilted platform with head-down (i.e. head-down bed~     rest - HDBR, or head-down tilt - HDT) during the exercise sessions, thus inducing a shift of~     body fluid toward the thorax. The most effective inclination angle has proved to be as low as~     -6°, thus constituting only minimal risks for the subjects. In practice, subjects will~     comfortably lay on the negatively tilted platform and will perform stepping at different~     intensities while their cardiovascular parameters are being monitored and recorded in~     encrypted form for subsequent analysis.~   "
95805|NCT02313129|"~     The purpose of this study is to increase our understanding of infertility in women with~     Rheumatoid Arthritis (RA). In this study the study team will compare the differences in~     ovarian reserve (the ability to provide egg cells that are capable of fertilization), the~     frequency of ovulation and the number of pregnancies between women with and without RA. It is~     possible that RA activity and medications limit ovarian reserve and ovulation, which may~     increase infertility among women with RA. There are several suspected causes for infertility~     in RA, including age-related fertility decline, inflammatory changes that impact endometrial~     receptivity and discourage implantation, accelerated ovarian decline due to certain arthritis~     medications and increased frequency of anovulation (a menstrual cycle during which ovaries do~     not release an egg) due to RA activity.~      This study is the first step toward our long term goal of increasing the ability of all women~     with RA to build the family they desire.~   "
95806|NCT02313116|"~     This intraoperative study is a prospective study analyzing specimens from fifty subjects.~     Patients scheduled to undergo breast-conserving surgery will be recruited in accordance with~     the inclusion and exclusion criteria. The study period per subject is the time it takes to~     assess the ex vivo breast tissue sample using the study device. Image review will be~     conducted during surgery and compared to the margin status findings in the post-operative~     pathology report.~   "
95807|NCT02313103|"~     This is a phase 1, open-label, parallel-group, single-dose study of lofexidine in 8 adult~     subjects with ESRD maintained on hemodialysis (3 times per week) and 8 control subjects with~     normal renal function, recruited as 1:1 matches to each ESRD subjects, matched for gender,~     age, and BMI.~   "
95809|NCT02313077|"~     The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and~     Ad26.ZEBOV as heterologous prime-boost vaccine regimens in healthy adult participants.~   "
95811|NCT02313051|"~     Everolimus has been approved to be effective when used with exemestane after progression on~     non-steroidal aromatase inhibitors in postmenopausal women based on the BOLERO-2 clinical~     trial. However, the superiority of addition of everolimus to endocrine therapy hasn't been~     established in the premenopausal women. This is a phase 2, multicentre clinical trial to~     evaluate the role of everolimus in the first-line endocrine treatment of premenopausal MBC~     patients after progression on tamoxifen.~   "
95812|NCT02313038|"~     Coronary heart disease (CHD) pose a serious health threat to population. PCI using drug~     eluting stents (DES), as a well-proved and booming measure in CHD management, is invasive and~     of high cost, however the knowledge about the real-life DES use and the efficacy and safety~     in China is limited. By consecutively recruiting first-ever PCI patients in 30 geographically~     representative highest-rank hospitals, this study will examine the prognosis in groups with~     different brands of DES, and various real-life factors, that may affect patients recovery~     after the procedure. Evidence for clinical practice and health resource allocation will be~     established based on the findings, to improve patients outcomes in future finally.~   "
95813|NCT02313025|"~     The language intervention 'Kaatje Klank' is designed for stimulating the speech production~     and speech perception skills of 4-year-olds in an early childhood educational setting, in~     order to stimulate early literacy skills. These skills are crucial skills for technical~     reading in later ages. Good reading skills are an important condition for academic success.~      To measure the effect of the language intervention 'Kaatje Klank', the intervention will be~     applied in six Dutch preschool classes (n = 100 children, 50% native speakers of Dutch, 50%~     non-native speakers) during 12 weeks (daily). Teachers will be trained and observed using a~     coaching trajectory.To measure the effect on speech production and perception skills, a pre-~     and posttest and a comparison with a matched control group (n = 100 children, 50% native~     speakers of Dutch, 50% non-native speakers) will be used. The control group will receive a~     different language intervention which focuses on vocabulary development (World-project).~   "
95814|NCT02313012|"~     The CC-90003-ST -001 trial is a first-in-man, open-label study in subjects with~     locally-advanced or wide spread cancers to determine if CC-90003 (an oral medication) can be~     adequately tolerated with minimal side effects.~   "
95815|NCT02312999|"~     Study goal: This study will examine whether there is a significant difference in~     postoperative outcomes between GDFT using a colloid solution versus a crystalloid solution.~      Hypothesis: Perioperative fluid optimization through the use of a closed-loop assistance with~     a balanced starch solution (volulyte®) will be associated with a decrease in postoperative~     complications compared to the same approach using a balanced crystalloid solution~     (Plasmalyte®).~      Objective: To establish which kind of intravenous fluid used for goal directed therapy with~     closed-loop assistance will reduce the number of postoperative complications (evaluation made~     by the POMS score).~   "
95816|NCT02312986|"~     This proposed protocol involves the use of the fecal microbiota transplantation (FMT) to~     suppress or reverse colonization with multidrug resistant organisms (MDRO) in subjects with~     recurrent MDRO infections due to organisms of likely enteric origin.~      FMT will be performed on subjects with a history of at least three recurrent infections due~     to MDRO; at least two recurrent, severe infections due to MDRO requiring hospitalization; or~     at least two recurrent infections due to MDRO for which only antimicrobials with rate~     limiting toxicities are available.~      The objective of this protocol is to determine if fecal microbiota transplantation (FMT) will~     be able to prevent additional recurrences of infections due to MDRO by suppressing or~     reversing enteric colonization with MDRO.~   "
95817|NCT02312973|"~     The study investigates the pharmacokinetics (absorption, distribution, elimination) of~     molidustat after intake of a single 75 mg tablet in subjects with renal impairment requiring~     hemo- or peritoneal dialysis compared to age-and gender-matched healthy subjects. In~     addition, the effect of molidustat on the hormone erythropoietin will be evaluated as well as~     the safety and tolerability of molidustat.~   "
95818|NCT02312960|"~     Patients will be followed up in this study after prior treatment with BAY 88-8223 /~     Radium-223 dichloride / Xofigo .~   "
95819|NCT02312947|"~     Comparative two methods of adenoidectomy means the coblation adenoidectomy with the cold~     dissection adenoidectomy specifically inquire which method is safer and more efficient.~   "
95820|NCT02312934|"~     The purpose of this study is to evaluate the use of a nicotine patch as a treatment for~     problems with attention, learning and memory in breast cancer patients who are 1-5 years post~     chemotherapy.~   "
95821|NCT02312921|"~     The main goal of the payment and delivery system reform is to reduce disparities in oral~     health and dental care access of low-income mothers and children living in rural Oregon~     counties. The target population is children, pregnant women and new mothers enrolled in~     Oregon Health Plan (OHP) in rural Oregon.~   "
95822|NCT02312908|"~     The purpose of this study is to determine whether clonazepam is effective and safe in the~     treatment of rapid eye movement behavior disorder (RBD) of patients with Parkinson's disease~     (PD).~   "
95823|NCT02312895|"~     This is a comparative study to determine if there is a difference in pain reduction and~     disability between dry needling and manual therapy for patients with low back pain. Subjects~     will be seen two times per week for 3 weeks (6 visits) and will receive either dry needling~     or manual mobilizations along with patient education and a home exercise program.~   "
95824|NCT02312882|"~     The purpose of this study is to investigate the ability of tofacitinib citrate, a Janus~     kinase inhibitor, to generate hair regrowth in patients with moderate to severe alopecia~     areata and its variants.~   "
95835|NCT02312739|"~     This is a randomized, double blind study that aims to measure the difference in maximum pain~     experienced during in-office transcervical sterilization (Essure®) for women receiving either~     inhaled nitrous oxide or standard oral analgesia (Vicodin and Lorazepam) with inhaled oxygen.~      The investigators hypothesize that inhaled nitrous oxide will reduce the pain experienced~     more than standard oral medications in women undergoing in-office transcervical~     sterilization.~   "
95850|NCT02312544|"~     To evaluate the safety and IOP lowering efficacy of OTX-TP, a sustained release travoprost~     drug product, placed in the canaliculus of the eyelid compared to Timolol Maleate Ophthalmic~     Solution, 0.5% in the treatment of subjects with open angle glaucoma or ocular hypertension.~     The study is designed to assess clinically meaningful response to treatment and is not~     powered to measure any efficacy endpoints with statistical significance.~   "
95825|NCT02312869|"~     In the general intensive care unit (ICU) population, there is strong evidence for benefit~     from lung-protective mechanical ventilation, including the use of low tidal volumes and~     adequate levels of positive end-expiratory pressure (PEEP). In burn patients it is highly~     uncertain whether these settings are beneficial and there are even concerns over safety of,~     in particular use of low tidal volumes. There is lack of international guidelines and~     consequently ventilation practice in burn patients may widely vary.~      The primary objective is to determine ventilation practice in burn ICUs worldwide, focusing~     on the size of tidal volumes and the levels of PEEP used for burn patients. In addition, data~     on other strategies considered important in patients who receive ventilation are also~     collected, including data on neuromuscular blocking agents, sedatives and analgesics, and~     type and amount of intravenous fluids used in the period of ventilation. The secondary~     objective is to determine the association between tidal volume size and levels of PEEP, and~     duration of ventilation in burn patients.~   "
95826|NCT02312856|"~     This study is designed to evaluate the safety of the PulseRider in patients undergoing~     treatment for bifurcation basilar or carotid terminus aneurysms.~   "
95827|NCT02312843|"~     The purpose of this research study is to examine the effects of high and low intensity~     exercise for those with mild memory loss and pre-diabetes. The investigators will also~     examine the effects of this exercise on certain proteins and hormones in body fluids, and on~     brain structure and function using magnetic resonance imaging (MRI). Recent studies indicate~     that exercise improves memory and thinking abilities for adults with mild memory loss OR~     pre-diabetes. This study examines the effects of exercise on people with mild memory loss AND~     pre-diabetes.~   "
95828|NCT02312830|"~     With the increasing successful use of allogeneic hematopoietic stem cell transplantation~     (HSCT) to cure advanced hematological disease, it becomes essential to evaluate the long-term~     effects of such a drastic treatment.~      This study investigates the prevalence of several demographic, psychosocial and behavioral~     aspects of survivorship after an allogeneic transplantation. Income, return to work, social~     isolation, pain, medication adherence, influenza vaccination status, alcohol use, smoking~     habits, drug use, healthy diet, prevention of UV exposure, physical activity, functional~     status/Quality of life (QoL), couple life/sexual function, depression, anxiety, spirituality~     and resilience will be studied.~   "
95829|NCT02312817|"~     Hepatocellular carcinoma (HCC) is the 9th leading cause of cancer-related death in the US and~     one of the leading causes of death in patients with cirrhosis. Fewer than 1 in 5 high-risk~     patients undergo HCC screening, with lower rates in non-Caucasian and low socioeconomic~     status patients receiving care through safety-net health systems. Screening and follow-up~     failures lead to more advanced cancers, when curative therapies are not available and~     survival is significantly worse. Over 60% of HCC are diagnosed at advanced stages, due to~     poor recognition of high-risk patients, underuse of screening among these patients, and poor~     follow-up of abnormal screening tests. To address these barriers, the investigators propose~     to conduct a comparative effectiveness research randomized controlled trial of three~     screening strategies among a socioeconomically disadvantaged and racially diverse cohort of~     cirrhotic patients at high risk for developing HCC.~      Overall, 1800 patients attending Parkland, the Dallas safety-net health system, will be~     randomized to:~        -  Group 1: Usual care, with visit-based HCC screening per discretion of individual~          providers~        -  Group 2: Mailed HCC screening invitation outreach to eligible patients (low resource~          intensity)~        -  Group 3: Mailed HCC screening invitation outreach to eligible patients combined with~          centralized patient navigation to promote screening completion and follow-up (high~          resource intensity)~      Through three specific aims, this effectiveness research randomized controlled trial will:~        -  Aim 1: Engage stakeholders in design and implementation of HCC screening outreach~          interventions.~        -  Aim 2: Compare the clinical effectiveness and patient acceptability of the intervention~          strategies to increase completion of one-time and repeat HCC screening.~        -  Aim 3: Evaluate whether intervention effects are moderated by patient sex, race,~          ethnicity, English proficiency, and connectedness to primary care.~      The screening intervention strategies combine EMR-enabled case identification, system-level~     screening outreach, and patient navigation to improve identification of previously~     unrecognized cirrhotic patients, promote HCC screening completion, and facilitate follow-up~     of abnormal screening tests. This study will engage stakeholders throughout the research~     process, evaluate the effectiveness and acceptability of HCC screening strategies, and~     determine which patient subgroups benefit the most.~   "
95830|NCT02312804|"~     This study will be conducted using 3+3 design and includes, a dose escalation part to define~     the MTDfRP2D for the combination of BGJ398 and carboplatin/paclitaxel, and a dose expansion~     part to treat another 12 patients (only cervix cancer) to further evaluate safety of this~     combination. Safety, tolerability and MTD will be determined in the dose escalation part of~     the study. The dose expansion will additionally investigate preliminary anti-tumor efficacy~     in cervical cancer. The dosing cycle is 21 days.~   "
95831|NCT02312791|"~     Understanding patient's prognosis is of utmost importance to determine radiotherapy's~     indication and dose/ fractionation. The investigators plan to conduct an observational study~     of prognosis of inpatients evaluated for palliative radiotherapy at a large cancer hospital~     in Brazil.~   "
95832|NCT02312778|"~     Non-specific low back pain is defined as a pain with no specific vertebral-related cause,~     such as infectious disease, tumor, osteoporosis, fracture, structural abnormality,~     inflammatory disease, radicular compressive syndrome or cauda equine syndrome. Non-specific~     low back pain is a common disease in many countries. This musculoskeletal disorder is costly~     to public health systems. Therefore, the use of manual therapies is important in the~     treatment of this disease and studies show the effectiveness of this type of therapy.~      Spinal manipulation is applied in manual therapies such as Osteopathy, Chiropractic and~     Physical Therapy and is widely used for acute and chronic non-specific low-back pain. There~     is moderate evidence that spinal manipulation is superior to sham spinal manipulation for~     improving short-term pain and function in chronic and acute non-specific low back pain.~     However the therapeutic mechanisms involved in this procedure are not well understood.~     Furthermore, while the high velocity and low amplitude spinal therapy has been shown to be~     effective in reducing pain and improving functional capacity in subjects with non-specific~     low back pain, the effect on postural variables have not been investigated. Therefore, the~     aim of this study is to evaluate the acute effect of lumbar manipulation on pain and postural~     variables.~      Twenty-four individuals with non-specific low back pain will be randomly allocated to two~     groups. The intervention group will receive high velocity and low amplitude spinal therapy,~     while the control group will receive sham manipulation. Immediately before and after the~     respective manipulation protocol, both groups will be evaluated regarding pain level, using a~     visual-analogue scale and algometer, and postural variables, using center of pressure~     displacement measured with the aid of a force plate. While the patient and therapist~     manipulator will be aware of the protocol applied in each case, the evaluator will be blind.~     A statistical treatment will be used to compare the results.~   "
95833|NCT02312765|"~     Sleep apnea, characterized by abnormal breathing at night, is often untreated in patients~     with heart failure. Helping patients to effectively use the most common form of treatment for~     sleep apnea, positive airway pressure therapy, can improve their heart function. This can~     reduce the likelihood that the patient will be re-admitted to the hospital. AirCareLabs has~     developed an innovative solution that allows patients to communicate with health care~     providers 24 hours a day, thus allowing them to get the help they need to effectively use~     positive airway pressure and thereby reduce the risk of being re-admitted to the hospital.~   "
95834|NCT02312752|"~     The purpose of the study is to determine whether a particular type of nerve fibers, A-delta~     fibers, can be tested in an Electromyography (EMG) lab on a routine basis. Normal, healthy~     volunteers will be enrolled in this study.~   "
96425|NCT02305030|"~     Single-centre, open-label, fixed-sequence design consisting of 2 periods separated by a~     washout period of at least 14 days.~   "
95836|NCT02312726|"~     The primary objective of this mixed methods pilot study is to understand women's experiences~     with postplacental intrauterine device (IUD) insertion through postpartum semi-structured~     interviews. For secondary objectives, the investigators will collect visual analog scale~     (VAS) and verbal rating score (VRS) data on women's pain experienced just before and~     immediately after IUD insertion. The investigators will perform postpartum interviews in each~     group until we reach thematic saturation. The investigators will recruit at least 60 women~     (30 each in the epidural and no epidural group) from the University of New Mexico Hospital~     (UNMH) affiliated antenatal clinics to conduct our quantitative data analysis.~   "
95837|NCT02312713|"~     The purpose of this study is to examine the effectiveness of standard physical therapy and an~     internet-based exercise program for people with knee osteoarthritis (OA). Both of these~     programs will be compared to a waiting list control group. The investigators hypothesize~     that both treatments will result in greater improvement than the control condition and that~     the treatments will be similarly effective. The investigators also expect that some patients~     may do better with one treatment type or another and will explore this.~   "
95838|NCT02312700|"~     The study is aimed to verify the effect of an online interactive tool on patient empowerment.~     The tool is based on a validated psychological questionnaire administrated to breast cancer~     patients before their first encounter with physician.~   "
95839|NCT02312687|"~     UX023-CL203 is a Phase 2b, open-label, long-term extension study. The study will be conducted~     in adults to assess the safety and pharmacodynamics of KRN23 administered via subcutaneous~     injections monthly (every 4 weeks) for a total of 68 weeks. The study will enroll~     approximately 25 adults with XLH who participated in Kyowa Hakko Kirin Pharma, Inc.'s (KHK's)~     study KRN23-INT-001 or KRN23-INT-002. Subjects will need to discontinue oral phosphate and~     vitamin D metabolite therapy prior to enrollment and throughout the duration of the study.~   "
95840|NCT02312674|"~     The aim of the randomized controlled study is to determine effects of an adjusted amount of~     oral nutritional supplements on the quality of life, the nutritional status, side effects,~     and response to therapy, in patients with pancreatic and hepatocellular carcinoma receiving~     palliative therapy.~   "
95841|NCT02312661|"~     Molecularly targeted agents which inhibit the mammalian target of rapamycin (mTOR) pathway~     and/or circumvent p53 in the induction of apoptosis are exciting potential targets in ovarian~     cancer. Metformin is a biguanide, widely used in the treatment of type 2 diabetes mellitus,~     that has shown anti-cancer activity in preclinical studies. The main mechanism of metformin's~     effect is mTOR pathway inhibition and, in addition, it has been shown to circumvent~     p53-induced apoptosis making it an exciting, potentially effective drug in ovarian cancer.~   "
95842|NCT02312648|"~     The objective of this study is to investigate the effects of a program of early mobilization~     in the functional capacity in patients undergoing coronary artery bypass grafting in short~     and long- term.~   "
95843|NCT02312635|"~     Traumatic Brain Injury (TBI) is the most common cause of death and long-term disability in~     children. Much of the long-term disability stems from neurocognitive impairments that are not~     greatly helped by current cognitive training and pharmacological treatments for TBI related~     cognitive impairments. This study tests the hypothesis that a drug, D-cycloserine (DCS), will~     significantly enhance the effect of cognitive training in correcting cognitive impairments in~     children with moderate/severe TBIs.~      In order to do so, study subjects who fit inclusion criteria, including those with moderate~     to severe TBI who show persistent working memory weaknesses based on a screening, will be~     recruited. They will have three visits to UCLA. During the first visit, subjects will undergo~     an MRI protocol before and after taking a pill (drug or placebo, blinded). They will also~     participate in a number of paper and pencil cognitive tests. Then subjects will be enrolled~     in a 6 week computerized cognitive training program (CogMed). They will also be prescribed a~     drug/placebo pill (depending on which group they are randomized into), which they'll have to~     take at regular intervals during the 6 weeks. They will have weekly check in phone calls or~     visits by a coach trained in the program to make sure they are following the study protocol~     accurately, to have their questions answered, and for motivation. At the end of the training~     period, subjects will return to UCLA to again complete the MRI protocol and cognitive~     testing. After three months of enrollment, they will have a final visit to UCLA, including~     only cognitive testing. A total of 30 subjects will be entered into the study.~   "
95844|NCT02312622|"~     This phase II trial studies how well pegylated irinotecan NKTR 102 works in treating patients~     with non-small cell lung cancer, small cell lung cancer, or breast cancer that has spread to~     the brain and does not respond to treatment. Pegylated irinotecan NKTR 102 may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
95845|NCT02312609|"~     The study was conducted as an open-label, balanced, randomized, two-treatment, two-period,~     two-sequence, single-dose, crossover, bioequivalence study comparing Minocycline~     hydrochloride extended release tablets 135 mg manufactured by OHM Laboratories Inc. with~     SolodynTM extended release tablets 135 mg manufactured by AAI Pharma, Inc Wilmington, NC~     28405 and manufactured for Medicis, The Dermatology Company Scottsdale, AZ 85258 in healthy,~     adult, human, male subjects under fed conditions.~   "
95846|NCT02312596|"~     A prospective, randomized, controlled, clinical study to establish clinical based evidence of~     PRP Concepts Fibrin Bio-Matrix and compare its performance with the usual and customary~     practice for the treatment of Wagner 1 or 2 DFUs.~   "
95847|NCT02312583|"~     iFighDepression is an online self-help programme based on cognitive-behavioral therapy that~     could be useful for the treatment of mild to moderate depression~   "
95848|NCT02312570|"~     To assess the efficacy of the PRP Concepts Fibrin Bio-Matrix and compare its performance with~     usual and customary practice for the treatment of chronic non-healing pressure ulcers (PU).~   "
95849|NCT02312557|"~     This phase II trial studies how well pembrolizumab works in treating patients with prostate~     cancer that has spread to other places in the body and keeps growing even when the amount of~     testosterone in the body is reduced to very low levels despite previous treatment with~     enzalutamide. Monoclonal antibodies, such as pembrolizumab, may block tumor growth in~     different ways by targeting certain cells.~   "
96426|NCT02305017|"~     Single-centre, open-label, randomised, two-way cross-over study consisting of 2 periods~     separated by a washout period of 14 days or more.~   "
95851|NCT02312531|"~     In this study, HBV-infected pregnant women were divided into two groups, those who received~     and those who did not receive hepatitis B immunoglobulin (HBIG) during pregnancy. In the~     mothers, the changes in HBV serum markers (hepatitis B surface antigen (HBsAg), hepatitis B~     surface antibody (HBsAb), HBeAg, hepatitis B core antibody (HBcAb)), and the DNA load were~     investigated. Immunohistochemical staining with custom-made antibodies against HBIG revealed~     both the level and distribution of HBIG in placentas. The protective mechanism of HBIG~     administrated during pregnancy was explored.~   "
95852|NCT02312518|"~     To assess the efficacy of the PRP Concepts Fibrin Bio-Matrix and compare its performance with~     usual and customary practice for the treatment of chronic non-healing venous leg ulcers~     (VLU).~   "
95853|NCT02312505|"~     The aim of the study is to investigate the accuracy of a new semi-invasive cardiac output~     monitoring system in patients undergoing elective cardiac surgery. The investigators~     hypothesize that the semi-invasive device may be affected by mean arterial pressure and~     systemic vascular resistance.~   "
95854|NCT02312492|"~     Specific Aim 1: To compare the metabolic fate (transport, conversion and oxidation) of~     labeled 18:0 (13C18:0) and its metabolic product 18:1 (13C18:1) in the fed state after~     habituation to diets enriched in the corresponding fatty acid.~      Hypothesis: In the fed state, the metabolic fate of 13C18:0 compared to 13C18:1 will be~     characterized by similar transport, higher conversion, and similar oxidation rates..~   "
95855|NCT02312479|"~     A prospective open-label, single treatment study to assess the safety and the performance of~     the Nyxoah SAT system for the treatment of Obstructive Sleep Apnea~   "
95856|NCT02312466|"~     The aim of this study is to monitor iodine nutrition in Switzerland in order to inform the~     authorities regarding iodine content in iodized salt. As a proxy for the entire population~     the investigators will study school aged children, pregnant women and women of reproduction~     age.~   "
95857|NCT02312453|"~     Abstract~      Introduction: The brachial plexus at the infraclavicular level runs deeper compared to its~     course proximally, giving rise to impaired needle visualisation due to the steep angle of~     needle insertion with the current ultrasound-guided approach. A new posterior parasagittal~     in-plane ultrasound-guided infraclavicular approach was introduced to improve needle~     visibility. However no further follow up study was done.~      Methods: We performed a case series and a cadaveric dissection to assess its feasibility in a~     single centre, University of Malaya Medical Centre, Kuala Lumpur, Malaysia from November 2012~     to October 2013. After obtaining approval from the Medical Ethics Committee, University~     Malaya Medical Centre, 18 patients undergoing upper limb surgery were prospectively~     recruited. A cadaveric dissection was also performed. The endpoints of this study were the~     success rate, performance time, total anaesthesia related time, quality of anaesthesia and~     any incidence of complications.~   "
95858|NCT02312440|"~     Recently, there has been interest in applying tranexamic acid topically before the closure of~     surgical wounds in total hip replacement. It has the advantages of ease of application,~     maximum concentration at the site of bleeding, minimising its systematic absorption and,~     potentially , decline the risks for systematic side-effects 。~   "
95859|NCT02312427|"~     We thought to investigate the influence of DPP-4 inhibitor on the serum BNP level of diabetic~     patients with congestive heart failure. This study consists of two protocols. In the first~     protocol, diabetic patients with high level of serum BNP (100-2000 pg/ml) receiving~     outpatient treatment with any type of DPP-4 inhibitor at our institution will be enrolled.~     After baseline data collection, DPP-4 inhibitor will be suspended for one month and serum BNP~     will be measured. The DPP-4 inhibitor will be resumed and after another month, serum BNP will~     be measured again. In the other protocol, diabetic patients who were hospitalized due to~     heart failure were enrolled. DPP-4 inhibitor will be started (if the patient is not taking a~     DPP-4 inhibitor) or suspended (if the patient is taking a DPP-4 inhibitor) after~     stabilization of heart failure, and serum BNP will be measured before and after the drug~     administration or suspension.~   "
95860|NCT02312414|"~     Anemia is a common disorder in CKD patients. It is largely attributed to decreased~     erythropoietin (EPO) production and iron deficiency. Therefore, besides EPO, therapy includes~     iron replenishment. However, the latter induces oxidative stress. Haptoglobin (Hp) protein is~     the main line of defense against the oxidative effects of Hemoglobin/Iron. There are 3~     genotypes: 1-1, 2-1 and 2-2. Hp 2-2 protein is inferior to Hp 1-1 as antioxidant. So far,~     there is no evidence whether haptoglobin genotype affects iron-induced oxidative stress in~     CKD patients.~      In this proposed study we wished to examine whether Hp genotype influences intravenous iron~     administration (IVIR)-induced oxidative stress in CKD patients, and its impact on the~     response of these patients to L-Carnitine therapy.~   "
95861|NCT02312401|"~     The purpose of this study is to better understand prostate cancer changes after radiation~     treatment, through magnetic resonance imaging (MRI). MRI is an imaging test that allows~     doctors to see prostate gland without any operation procedures. It can help identifying the~     tumors in the prostate. For patients with newly diagnosed prostate cancer, MRI may help~     doctors manage treatment better and sooner.~   "
95862|NCT02312388|"~     The purpose of this study is to compare the differences in central venous catheter insertion~     time, success rate, and complication between thin-wall needle technique and~     catheter-over-the-needle technique for central venous catheterization in children.~   "
95863|NCT02312375|"~     This study was designed to evaluate the effect of ARB in improving insulin secretion in~     patients with type 2 diabetes. The investigators also aimed to evaluate if there are~     potential synergisms between ARB and DPP4 inhibitors in improving insulin secretion and~     urinary albumin secretion in diabetic patients.~   "
95864|NCT02312362|"~     Objective:~      To compare intraocular pressure lowering effect of combined sclerotomy ab interno with~     phacoemulsification and phacoemulsification alone, in primary or secondary open angle~     glaucoma patients.~      Study design:~      Prospective, randomized, case- control interventional surgical trial~   "
95865|NCT02312349|"~     Celiac disease (CD) is a chronic autoimmune disorder in genetically susceptible individuals~     characterized by inflammation of the small intestine due to gluten intolerance. This protein~     is found in cereals such as wheat, barley and rye. In Argentina, oats are also considered a~     toxic grain since are as highly contaminated as the previous three. For this reason, the~     acronym TACC (Trigo, avena, cebada y centono: wheat, oats, barley and centono) is used for~     their identification. An effective treatment for celiac disease consists in a gluten-free~     diet (GFD). For most patients, a gluten-free intake results in a symptomatic and pathological~     complete remission and decreases the risk of complications.~      The overall prevalence of CD is around 1% in several Western countries. An Argentinian study~     shows a 1.167 prevalence of CD in studied patients, being doubled for women than men. Another~     study in a closed population of the Health Plan of Hospital Italiano de Bs As estimated a~     prevalence of 0.22 CD diagnosis. In developed countries, for each diagnosed case there is an~     average of 5-10 cases that have not been diagnosed yet.~      CD patients and their families should be properly informed about GFD, since there are many~     factors, voluntary and involuntary, which can affect the treatment. Even though a strict diet~     is imperative, food handling awareness is equally important in order to prevent~     cross-contamination and gluten intake hidden in certain products.~      In recent years, several countries have shown an increasing interest in improving the supply~     of gluten-free foods in supermarkets, food factories and restaurants. In turn, a British~     study shows that chefs have less awareness about celiac disease than the overall population.~     Another Canadian study, which assessed the quality of life of people with CD, revealed that~     80% of them avoid eating in restaurants for fear of contamination, causing a decrease in~     their social life.~      In Argentina, there are associations that generate lists of marks and gluten-free products~     allowing safe intake of processed foods, however, it is unknown the food supply suitable for~     consumption for people with CD as well as the staff's knowledge in gluten-free food~     preparation in restaurants, pubs, pizzerias and fast food places. U.S. has quality assurance~     systems that certify good manufacturing practices and GFD handling in restaurants and selling~     local foods, although its application is not mandatory. In our country, there is no such~     certification, so food safety on restaurants can not be guaranteed.~      Eating behaviors are influenced by the reality in which people live, including food~     availability indoors and outdoors. The current lifestyle leads more and more people to make~     meals away from home, so that the variety and quality of food sold in restaurants and other~     stores conditions the consumption. Thus, the availability of safe foods in places where~     people with CD carried some of their meals, help improve adherence to the GFD.~      The aim of this study is to investigate gluten-free products' supply in elaborated food~     stores in Buenos Aires City and to discover the level of information possessed by~     manufacturers in the production of food.~   "
95902|NCT02311855|"~     The main objective is to evaluate the strength and duration of immune response after~     influenza vaccination in patients with Rheumatoid Arthritis (RA) receiving treatment with~     biological agents as compared to a group healthy controls who do not have RA. Influenza~     vaccine titers will be drawn 3 times: at Baseline(prior to vaccination), 4-6 weeks post~     vaccination, and 5-6 months post vaccination. Influenza vaccination will be done at the~     baseline visit after the baseline blood draw.~   "
95866|NCT02312336|"~     Patients with heart attacks caused by blocked coronary arteries are usually treated with a~     technique called primary angioplasty. Although this treatment is very successful it can~     result in damage to the heart muscle when the artery is opened due to reperfusion injury.~     Cooling the entire body has been shown to reduce heart muscle damage during heart attacks in~     some patients but not in others, however it is uncomfortable due to the shivering, expensive~     and can result in delays in opening the blocked artery. We are investigating a simpler way to~     cool the heart muscle directly using cooled fluid passed through the catheter without the~     shortcomings of entire body cooling. This pilot will address safety and feasibility~     considerations.~   "
95867|NCT02312323|"~     Comparison of different contact lens materials.~   "
95868|NCT02312310|"~     to assess the effect of differing amounts of a cocoa-derived dietary flavanol (epicatechin )~     on dentate gyrus function and corresponding cognitive function~   "
95869|NCT02312297|"~     The study was conducted as an open-label, balanced, randomized, two-treatment, two-period,~     two-sequence, single-dose, crossover, bioequivalence study comparing Minocycline~     hydrochloride extended release tablets 135 mg manufactured by OHM Laboratories Inc. with~     SolodynTM extended release tablets 135 mg manufactured by AAI Pharma, Inc Wilmington, NC~     28405 and manufactured for Medicis, The Dermatology Company Scottsdale, AZ 85258 in healthy,~     adult, male, human subjects under fasting condition.~   "
95870|NCT02312284|"~     The aim of this observational study is to retrospectively collect current survival data for~     3995 primary rectal cancer patients who were extracted from 5097 rectal cancer patients~     admitted in Cancer Hospital, Chinese Academy of Medical Sciences from January 2000 to~     December 2010. Moreover, based on a Cox model, we want to develope a nomogram that predicts~     local recurrence, distant metastases, and survival for patients with rectal cancer treated~     with pre- or postoperative chemoradiotherapy (CRT).~   "
95871|NCT02312271|"~     This prospective observational study seeks to assess ability to achieve enteral feeding goals~     with standard tube feeding formulas.~   "
95872|NCT02312258|"~     The purpose of this study is to determine the effect of ixazomib maintenance therapy on~     progression free survival (PFS) compared with placebo, in participants with newly diagnosed~     multiple myeloma (NDMM) who have had a major response (complete response [CR], very good~     partial response [VGPR], or partial response [PR]) to initial therapy and who have not~     undergone stem-cell transplantation (SCT).~   "
95873|NCT02312245|"~     This phase II trial studies how well Avatar-directed chemotherapy works in treating patients~     with ovarian, primary peritoneal, or fallopian tube cancer that does not respond to platinum~     anti-cancer drugs. Drugs used in chemotherapy, such as paclitaxel, gemcitabine hydrochloride,~     pegylated liposomal doxorubicin hydrochloride, topotecan hydrochloride, work in different~     ways to stop the growth of tumor cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may~     interfere with the ability of tumor cells to grow and spread. Using an Avatar, a living tumor~     sample with similar genetic characteristics to the original tumor, may help determine which~     chemotherapy is most effective.~   "
95874|NCT02312232|"~     The purpose of this study is to investigate the pharmacokinetics of levodopa, carbidopa,~     3-OMD and ODM-104 after repeated doses of 3 levodopa formulations given in combination with~     carbidopa and ODM-104.~   "
95875|NCT02312219|"~     HIV-infected individuals on antiretroviral therapy (ART) are at increased risk for~     cardiovascular disease (CVD), likely due to chronically increased inflammation. Low-dose~     methotrexate (LDMTX) may reduce CVD risk in people with rheumatoid arthritis, who like those~     with HIV, have increased levels of inflammation. The NHLBI is funding a clinical trial~     targeting the excess inflammation in HIV. That Parent Study is a randomized, double-blind,~     placebo-controlled trial that will assess whether 24-week treatment with LDMTX: i) is safe,~     ii) reduces circulating inflammatory biomarkers and levels of immune cell activation and iii)~     improves brachial artery reactivity. However, neither the biomarkers nor endothelial function~     tests measured as part of the parent study will report on atherosclerotic inflammation, (the~     desired pathobiological target of LDMTX therapy in HIV). As such, the direct evaluation of~     arterial inflammation would substantially enhance the scientific value of the trial. In this~     imaging sub-study, the overall goal is to determine if treating virologically suppressed,~     HIV-infected individuals with LDMTX will reduce inflammation within the arterial wall.~      This fully integrated ancillary study would, in a subset of patients enrolled in the parent~     trial: (i) assess the impact of LDMTX on arterial inflammation, (ii) evaluate mechanisms~     responsible for arterial inflammation in HIV and iii) explore mechanisms responsible for~     actions of LDMTX on the artery wall. Accordingly, the proposed study would provide unique and~     highly complementary information that would greatly increase the knowledge and mechanistic~     insights gained from Parent Study. The ancillary study has two specific aims1) To determine~     the impact of anti-inflammatory treatment with LDMTX on arterial inflammation, as assessed by~     FDG-PET/CT imaging, in virally suppressed HIV-infected individuals., and 2) To evaluate the~     cellular and biochemical basis of the effect of LDMTX therapy on arterial inflammation in~     HIV.~   "
95876|NCT02312206|"~     This is a multi-center, international, randomized, double-blind, placebo-controlled, two-arm~     efficacy and safety study in subjects newly diagnosed with AL amyloidosis. Subjects will~     remain on-study until study completion, which will occur when all primary endpoint events~     (all-cause mortality or cardiac hospitalizations) have been reached.~   "
95877|NCT02312193|"~     Aim of this study is to enhance the knowledge of myogenic tone alterations in hypertensive~     patients and to better understand the mechanisms controlling the myogenic tone. Evaluations~     will be performed through ex vivo studies of peripheral arterioles in human adipose tissue~     from lumbar muscle, isolated from biopsies. This will allow investigators to evaluate the~     myogenic function in response to progressive blood pressure increases, in order to correlate~     myogenic function to arterial hypertension and to the molecular mechanisms already identified~     in the preclinical models.~   "
95878|NCT02312180|"~     ProMetic is intiitating a first-in-man study entitled A Phase 1, Dose Escalation, and~     Pharmacokinetic Study of ProMetic Plasminogen Administered as Intravenous Infusion in Adults~     and Children with Hypoplasminogenemia. The general objectives of this clinical study,~     (Protocol #2002C005G), are to determine the optimal dose and interval required to support the~     planned Phase 2/3 study and to investigate initial safety and tolerability.~   "
95879|NCT02312167|"~     This study aims at demonstrating the feasibility of probe-based confocal laser endomicroscopy~     (pCLE) and needle-based confocal laser endomicroscopy (nCLE).~      Contraindications for resection surgery may sometimes be missed during exploratory surgical~     procedures. That may lead to an incomplete thus useless surgery and delay the right~     treatment.~      The objectives of this study are to improve the detection of cancer extension during~     exploratory procedures and to guide resection to ensure clear margins.~   "
96486|NCT02304237|"~     This study is for compare the efficacy of two different regimens(vaginal vs intramuscular) of~     progesterone therapy in prevention of preterm birth in high risk pregnant women.~   "
95880|NCT02312154|"~     IMPORTANCE Skin rejuvenation can be achieved effectively and safely by injection of a~     stabilized hyaluronic acid (HA)-based gel of nonanimal origin (NASHA) injection using a~     stamp-type electronic multineedle injector.~      OBJECTIVE To determine the efficacy and safety of NASHA using a stamp-type electronic~     multineedle injector, and if changes in skin physiology occur earlier than in previous~     trials.~      DESIGN, SETTING, AND PARTICIPANTS Twenty-five patients were recruited to this single-center,~     evaluator-blinded, prospective, balanced (1:1), split-face randomized clinical trial.One~     dermatologist who was blinded as to the treatment side evaluated the skin hydration, melanin~     content, erythema, and elasticity of both cheeks using a corneometer, a mexameter, and a~     reviscometer, respectively, at each follow-up visit (0, 1, 2, 4, 8, and 12 weeks~     postinjection). The subjects and two independent investigators assessed the clinical~     improvement using the Global Aesthetic Improvement Scale (GAIS) at the every visit.~     Twenty-four participants completed the study, and no participants withdrew due to adverse~     effects.~      INTERVENTIONS Each participant submitted to a single treatment with a NASHA injection to one~     side of the lower cheek. The cheek side to which the treatment was applied was chosen~     randomly.~   "
95881|NCT02312128|"~     The purpose of this study is to evaluate if an early mobilization after distal radius~     fractures treated by surgery leads to an better functional outcome then immobilization after~     surgery for 5 weeks in a cast~   "
95882|NCT02312115|"~     This study will be a randomized prospective double-blind placebo-controlled clinical pilot~     trial. This will be a single center project that will take place at Loma Linda University~     Medical Center. All adult kidney recipients will be informed of the study prior to operation.~     The Nephrology fellows or attending physicians will attempt to obtain informed consent from~     all eligible patients, pre-transplant. Those patients who consent will be screened post~     operation for enrollment. Patients who do not meet all eligibility criteria and/or who meet~     some exclusion criteria will be deemed ineligible for the trial, and will be excluded. The~     Nephrology and Transplant teams will be blinded of patient assignment and only the pharmacy~     will know the patient's assignment.~   "
95883|NCT02312102|"~     This research study is evaluating drugs called bortezomib and lenalidomide as a possible~     treatment for myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).~      The purpose of this research study is to determine the safety and efficacy of the bortezomib~     and lenalidomide investigational combination. This drug combination has been used in the~     treatment of relapsed/refractory multiple myeloma and has been previously investigated in the~     treatment of MDS and AML, albeit at a lower dose of lenalidomide. In this research study, the~     investigators are looking for the highest dose of the combination that can be given safely~     and see how well it works as a combination for MDS and AML in individuals whose disease has~     relapsed after an SCT.~   "
95884|NCT02312089|"~     Evaluation of the effect of adding a single dose of gonadotropin releasing hormone agonist~     (GnRHa) as a luteal phase support on the outcomes of intracytoplasmic sperm injection (ICSI)~     following GnRH antagonist protocol~   "
95885|NCT02312076|"~     Evaluation of the effect of adding a single dose of gonadotropin releasing hormone agonist~     (GnRHa) as a luteal phase support on the outcomes of intracytoplasmic sperm injection (ICSI)~     following long GnRHa protocol~   "
95886|NCT02312063|"~     In a prospective, randomized case-controlled study, the investigators hope to demonstrate a~     positive correlation of plasma levels of EPA and DHA as well as fish intake with the~     HbA1c-lowering effect of sitagliptin but not with the active comparator glimepiride.~   "
95887|NCT02312050|"~     A phase 2b, placebo-controlled, randomized, double-blind, multi-center study of GCS-100 in~     patients with chronic kidney disease caused by diabetes. The study will enroll approximately~     375 patients at multiple centers located in the United States. Study duration is 6 months.~     Patients will be randomly assigned 1:1:1:1 to treatment with placebo (0.9% Sodium Chloride~     Injection, USP), 1 mg, 3 mg, or 9 mg GCS-100. All doses of study drug will be administered~     via intravenous (IV) push injection once weekly for 2 months (8 weeks), then every other week~     for an additional 4 months (16 weeks).~   "
95888|NCT02312037|"~     An expanded access/compassionate use protocol that allows access to Mylotarg for~     relapsed/refractory AML CD33 positive patients in the USA.~      Contact: B1761026@iconplc.com~   "
95889|NCT02312024|"~     Registry on the use of the CytoSorb® adsorber in ICU patients.~   "
95890|NCT02312011|"~     This study will test the safety, tolerability, and pharmacokinetics of multiple escalating~     doses of ISIS-DMPKRx administered subcutaneously to adult patients with DM1.~   "
95891|NCT02311998|"~     There are 2 parts to this study: Part 1 (dose escalation) and Part 2 (dose expansion).~      The goal of Part 1 of this clinical research study is to find the highest tolerable dose of~     the combination of bosutinib and inotuzumab ozogamicin that can be given to patients with~     Philadelphia positive (Ph+) acute lymphoblastic leukemia (ALL) and chronic myeloid leukemia~     (CML) in the lymphoid blast phase that also expresses CD22 (a type of protein on the leukemia~     cell).~      The goal of Part 2 is to learn if the dose found in Part 1 can help to control the disease.~      The safety of this drug combination will also be studied.~      This is an investigational study. Inotuzumab ozogamicin is not FDA-approved or commercially~     available. Bosutinib is FDA-approved and commercially available for the treatment of certain~     types of CML in patients who have failed previous therapies. It is considered investigational~     to use this combination of drugs to treat Ph+ AML/CML.~      Up to 80 participants will be enrolled in this study. All will take part at MD Anderson.~   "
95892|NCT02311985|"~     The aim of this study is to compare three different blood transfusion strategies for~     coagulopathy correction before central venous catheterization in patients with chronic liver~     failure (cirrhosis and/or chronic liver graft dysfunction) admitted in intensive care unit.~   "
95923|NCT02311582|"~     The blood brain barrier (BBB) is a major obstacle to drug delivery in the treatment of~     malignant brain tumors including Glioblastoma multiforme (GBM). MRI-guided laser ablation~     (MLA) has been noted to disrupt peritumoral BBB, which could then lead to increased access of~     new tumor antigens to the lymphovascular system and vice versa of immune effector cells to~     the tumor for effective activation of the immune system. Therefore the combination of MK-3475~     and MLA as proposed in this protocol is hypothesized to create a therapeutic synergy in which~     MLA increases material access to promote immune activation and then MK-3475 maximizes these~     tumor-specific immune reactions to impart effective tumor control.~   "
95893|NCT02311972|"~     Very low birth weight (VLBW) infants (<1500 grams at birth) and other low birth weight~     infants experience hypothermia after birth and through stabilization (first 24 hours of life)~     due to an inability to keep warm through metabolic heat production while experiencing heat~     loss during care.~      The investigator hypothesizes that inserting an InnerSense oral gastric tube (Philips~     Healthcare) with its imbedded thermistor and attaching the tube to a temperature monitor with~     a digital temperature display will enable care-providers to monitor continuous body~     temperature and prompt them to provide warmth and prevent heat loss, thus preventing~     hypothermia in these infants for the first 24 hours of life. The investigator predicts~     infants in the intervention group will have warmer axillary temperatures upon admission to~     the NICU and at 1, 4, and 8 hours of age. Mothers in non-active labor will be sought for~     consent to enroll their VLBW infant into this study after the infant's birth. 160 VLBW~     infants and other low birth weight infants 1000-2000 grams will be randomized to the~     intervention group (placement of InnerSense oral gastric tube with thermistor to a Squirrel~     monitor for continuous digital temperature display, immediately after birth through 24 hours~     of life) or the control group (standard delivery room care and stabilization care). The study~     staff plans to enroll 180 infants (90 per group) to allow for screen failures. Axillary~     temperatures of all infants will be recorded at NICU admission, 1, 4, 8 and 24 hours of age.~     Further, the study staff intends to enroll approximately 300 Intensive Care Nursery providers~     who care for an InnerSense study infant and wish to complete a provider satisfaction survey.~     These providers will be asked to provide consent prior to completing the survey and their~     names will be recorded on a separate study enrollment log.~      Infant demographic data will be compared to make sure groups are not significantly different.~     Temperatures from the intervention group will be compared to the control group using a~     student t test at each time point. Satisfaction questionnaires will be summarized and~     described. The InnerSense oral gastric tube with temperature monitoring is FDA approved for~     use and is being marketed commercially by Philips Healthcare. VLBW infants have oral gastric~     tubes placed as standard of care for feeding, and intermittently in the delivery room when~     positive pressure ventilation is necessary for respiratory stabilization. There are no~     additional safety risks to the intervention of this study; however, a safety/data monitoring~     committee will be formed and meet quarterly to monitor the trial.~   "
95894|NCT02311959|"~     This is a phase III, multicentric, single arm study with a sequential design using the exact~     conditional Poisson test.~      The primary objective of this prospective study is to evaluate whether selected breast~     carcinoma patients could be treated with nipple sparing mastectomy (NSM) with an acceptable~     low local recurrence rates.~      450 patients will be included over a period of 4 years and will be followed for a 5 years~     period (twice a year).~      All patients must have a complete preoperative evaluation (bilateral mammography, bilateral~     breast ultrasonography +/- MRI), and a histopathological diagnostic proof of carcinoma~     (invasive or in situ, all histopathological types, first treatment or relapse).~      The study procedure is represented by nipple areola skin-sparing mastectomy followed by~     immediate breast reconstruction.~      After surgery, early and late complications, including specific complications (suffering of~     the nipple-areolar complexe and suffering of the skin flaps), will be evaluate.~      An esthetic evaluation (by patient and clinician) and a quality of life evaluation will be~     realized throughout the study.~      A complementary study, prospective, non-interventional, will be proposed to patients who will~     benefit from the same surgical technique (NSM) followed by immediate reconstruction, but in~     the context of preventive surgery (prophylactic surgery for patients mutated or high genetic~     risk). The aim of this complementary study, which will include a maximum of 60 patients, is~     to evaluate associated morbidity in prophylactic NSM.~      Data will be collected over a 3 months period after surgery.~   "
95895|NCT02311946|"~     This study will investigate whether concurrent administration of rabeprazole, an antacid~     known as a proton pump inhibitor, alters the absorption of the drug palbociclib when given as~     one of six experimental formulations.~   "
95896|NCT02311933|"~     This randomized phase II trial studies how well tamoxifen citrate works compared with~     z-endoxifen hydrochloride in treating patients with breast cancer that has spread to nearby~     tissue or lymph nodes or other parts of the body and has estrogen receptors but not human~     epidermal growth factor receptor 2 (HER2) receptors on the surface of its cells. Estrogen can~     cause the growth of tumor cells. Hormone therapy using tamoxifen citrate or z-endoxifen~     hydrochloride may fight breast cancer by lowering the amount of estrogen the body makes. It~     is not yet known whether tamoxifen citrate or z-endoxifen hydrochloride is more effective in~     treating patients with breast cancer.~   "
95897|NCT02311920|"~     This phase I trial studies the safety and best dose of ipilimumab, nivolumab, or both in~     combination with temozolomide in treating patients with newly diagnosed glioblastoma or~     gliosarcoma. Monoclonal antibodies, such as ipilimumab and nivolumab, may block tumor growth~     in different ways by targeting certain cells. Drugs used in chemotherapy, such as~     temozolomide, work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. It is not yet~     known which combination is a better treatment for glioblastoma or gliosarcoma.~   "
95898|NCT02311907|"~     This randomized phase III trial is studying glutathione to see how well it works in~     preventing peripheral neuropathy caused by paclitaxel and carboplatin in patients with~     ovarian cancer, fallopian tube cancer, and/or primary peritoneal cancer. Drugs used in~     chemotherapy work in different ways to stop the growth of cancer cells, either by killing the~     cells or by stopping them from dividing. Chemoprotective drugs, such as glutathione, may help~     prevent peripheral neuropathy caused by paclitaxel and carboplatin. It is not yet known~     whether glutathione is more effective than a placebo in preventing peripheral neuropathy.~   "
95899|NCT02311894|"~     This is a Phase IV, multicenter, open-label, single-arm study of somatropin (rDNA origin)~     (Nutropin AQ v1.1) in pre-pubertal children with growth hormone deficiency (GHD) naïve to~     prior recombinant human growth hormone (rhGH) treatment. The study is designed to~     characterize the immunogenicity profile of somatropin (rDNA origin) injection when~     administered daily subcutaneously for 12 months. The clinical impact of immunogenicity will~     also be assessed.~   "
95900|NCT02311881|"~     The purpose of the study is to determine whether paracetamol 1000 mg sustained-release (SR)~     tablets administered orally, twice daily are effective and safe in the treatment of patients~     with osteoarthritis of the knee or hip.~   "
95901|NCT02311868|"~     The interest on gastrointestinal (GI) dysfunction in hemodialysis has been growing in the~     last years. it is now accepted that GI dysfunction in dialyzed patients may contribute to~     systemic microinflammation by promoting gut dysbiosis and bacterial translocation in the~     blood. Another mechanism by which GI dysfunction contributes to systemic symptoms is related~     to metabolic activity of the dysbiotic microflora growing in the gut of these patients to~     generate toxic compounds such as phenols, indoles, and amines. Epidemiological evidence has~     strongly linked one of these compounds, p-Cresol, to cardiovascular risk and mortality in~     hemodialysis patients. In the present paper the investigators investigated the effect of a~     probiotic/prebiotic mixture on plasma p-cresol concentrations and GI symptoms and in~     hemodialysis patients.~   "
95947|NCT02311270|"~     The purpose of this study is to learn about the effects of long term carnitine use in~     patients with metabolic disorders and its potential relationship to cardiovascular events.~   "
95903|NCT02311842|"~     Ankylosing spondylitits (AS) is a chronic, systemic rheumatic disease primarily affecting~     spine and sacroiliac joints, which belongs to the group of conditions known as~     spondyloarthopathies and causes eventual fusion of the spine. Twin study in AS estimated a~     heritability of over 90%. HLA-B27 is regarded as the earlist and most important gene~     associated with AS heritability, and over 90% of AS patients carry HLA-B27 gene. HLA-B27 was~     highly polymorphic, and more than 89 subtypes of B27 gene have been found. Subtypes of~     HLA-B27 vary between different regions, and so on as the relationship between HLA-B27~     subtypes and disease development among different races. Anti-TNF- agents were regarded as one~     milestone in recent years development on treatment of ankylosing spondylitis, and most~     patients showed significant improvement after anti-TNF- therapy. Yet part of patients still~     showed insufficient response. Our previous study suggested AS patients carrying different~     genotype of SNP in TNF gene had different response to anti-TNF- therapies. But more studies~     should be carried out to identified more gene polymorphisms associated with treatment~     response. In this study we designed a prospective, open-label trial to investigate the~     genetic difference beween AS patients with different response to anti-TNF- therapy. We plan~     to enroll 50-100 early AS patients which fulfill the 2009 ASAS axial spondyloarthritis~     classification criteria and have axial symptom for no more than 2 years. The patients must~     have high disease activity defined as BASDAI 4, and HLA-B27 test must be positive. The~     patients should be able to receive 24 weeks of etanercept treatment. And patients who have~     previous other anti-TNF- therapy and any contraindication of anti-TNF- therapy must be~     excluded. Other medicines should be stable for at least 4 weeks before etanercept treatment~     begins. For the clinic assessment, patients should fill in the AS questionaires and receive~     physical examination at each visit. ASAS20 is thought as the primary endpoint. For the~     genetic polymorphysm detection, we select 10-20 SNP in MHC region associated with AS and 5-10~     HLA-B27 subtypes which have been worked over and have definite association with AS. At the~     first visit 4ml of anticoagulated blood was collected and DNA was extracted. Target SNPs are~     detected by PCR then direct sequencing. HLA-B27 subtypes are identified using PCRSSP methods.~     And the relationship between SNPs/HLA-B27 subtypes and different response to anti TNF-~     therapy is accessed using chi-square statistic process in SPSS software. In this study we~     plan to investigate the relationship between genetic background and the clinical response to~     anti-TNF- therapy in AS patients, which has been seldom reported before. Our group have been~     studying the disease-associated gene of AS for years, and got plenty of data and experience~     about genetic study of AS.~   "
95904|NCT02311829|"~     The goal of this study is to evaluate effectiveness of the phone follow-up method compared to~     the conventional filler taken one.~   "
95905|NCT02311816|"~     The value of procalcitonin change from the day before to the day when infection was suspected~     in predicting bacterial infection in intensive care patients.~   "
95906|NCT02311803|"~     TME (Total mesorectum excision) is the golden standard of radical resection for mid-low~     rectal cancer. However, the damage of pelvic autonomic nerve following with TME principle~     will lead to high incidence of urinary and sexual function disorder. PANP (pelvic autonomic~     nerve preservation) surgery played a role in decreasing incidence of urinary and sexual~     function disorder. However, 32%-44% patients still suffered from urinary and sexual function~     disorder when underwent open (O-PANP-TME) or laparoscopic PANP TME surgery (L-PANP-TME).~      In the early stage of work, the investigators performed preservation of Denovilliers' fascia~     in L-PANP-TME to discuss the protection of urinary and sexual function of male mid-low rectal~     cancer patients. The results showed that preservation of Denovilliers' fascia in L-PANP-TME~     significantly decreased incidence of urinary and sexual function disorder. In order to~     further confirm the early work, the investigators design a randomized controlled clinical~     trial to compare differences in urinary and sexual function protection and long-term outcomes~     between preservation and excision of Denovilliers' fascia in L-PANP-TME.~   "
95907|NCT02311790|"~     Trans-palmitoleic acid (trans-C16:1) is a naturally occurring trans fatty acid present in~     small quantities in foods, most notably in dairy products. Observational evidence suggests a~     positive association between trans-C16:1 and insulin sensitivity, and negative association~     with risk of developing type 2 diabetes mellitus [1-3]. Cis-palmitoleic acid (cis-C16:1) is~     found naturally in foods and is particularly high in macadamia nuts and oil extracted from~     the sea buckthorn plant. Animal models suggest that this palmitoleic acid isomer also~     improves insulin sensitivity and reduces metabolic dysfunction.~      This pilot dosing study is necessary to inform the design of a larger trial to test the~     hypothesis that both trans-C16:1 and cis-C16:1 improve insulin resistance but at different~     doses. Plasma phospholipid fatty acid profiles will be used as the primary outcome measure.~   "
95908|NCT02311777|"~     Phantom limb pain (PLP) is as painful sensations located to the missing limb and classified~     as neuropathic pain. In the United States, an estimated 1.7 million patients have undergone~     limb amputation, and 60% to 80% of these patients develop PLP (1-2) and it is usually~     resistant to a wide variety of treatments (1-4). Three factors may contribute to the~     development of persistent, post-amputation PLP by inducing central sensitization at different~     times relative to surgery: pre-amputation pain, noxious intraoperative stimuli, and acute~     postoperative pain (5-7).~      Investigators hypothesis that pre-amputation period could be important in eliminating Phantom~     Limb Pain (PLP) in the patients in whom cortical reorganization is not yet established. The~     reduction of pre-operative pain and prevention of formation of pain memories may eliminate~     development of PLP by using dual networks treatment strategy. This Phase III, randomized,~     double-blind, placebo-controlled study is designed to evaluate the efficacy of pre-operative~     pregabalin (lyrica) and ketamine in eliminating phantom limb pain in patients undergoing~     lower limb amputation.~   "
95909|NCT02311764|"~     Open label, non-randomised phase II clinical pilot study~   "
95910|NCT02311751|"~     In this study, the investigators will be examining the effects of repetitive transcranial~     magnetic stimulation (rTMS) on executive function deficits in individuals with autism~     spectrum disorder. Half of the participants will be chosen by chance to receive active rTMS~     stimulation while half will be chosen by chance to receive sham rTMS. Sham rTMS will feel the~     same as active rTMS only there will be no direct brain stimulation. This is necessary to~     ensure that active rTMS is efficacious in the enhancement of executive function in~     individuals with autism spectrum disorder. Based on results from a recently published pilot~     study, the investigators propose that active rTMS treatment will result in a significant~     improvement in working memory performance compared to sham rTMS treatment.~   "
95948|NCT02311257|"~     The purpose of this study is to learn about the use of nutritional supplements in patients~     with mitochondrial disease.~   "
95949|NCT02311244|"~     This observational study is aimed at identifying new molecular promoters of mortality (and~     morbidity) in patients with type 2 diabetes mellitus (T2DM).~   "
95950|NCT02311231|"~     In this trial we test the hypothesis that PCI and bivalirudin is superior to heparin alone~     (according to local protocol) in reducing death, MI, and major bleeding in patients with~     NSTEMI or STEMI at 180 days (primary end point), treated with ticagrelor or prasugrel.~   "
96013|NCT02310412|"~     The objective of this study is to test the hypothesis that INTERCEPT platelet components~     stored for 7 days retain sufficient viability for therapeutic efficacy. The post-infusion~     recovery and lifespan of 7-day old INTERCEPT platelet components stored in 35% plasma and 65%~     InterSol or stored in 100% plasma, will be measured in comparison to fresh radiolabeled~     platelets according to FDA guidance for platelet testing (FDA 1999).~   "
95911|NCT02311738|"~     Regular exercise has several positive health effects including increased physical fitness and~     muscle mass. It is well known that increased muscle mass is associated with increased resting~     energy expenditure which may facilitate weight loss and maintenance. Previous studies have,~     however, failed to show any consistent association between the intensity of physical exercise~     and energy expenditure, or relate the variance in these adaptations to genetic variability.~     Whether high-intensity exercise (HIE) is associated with improved health related quality of~     life in severely obese patients remains unknown.~      This PhD-project is based on a planned randomised controlled study including 50 or more~     treatment seeking morbidly obese patients who will be randomised to either a 24 week~     moderate-intensity exercise (MIE) programme or a 24 week high-intensity exercise (HIE)~     programme. The investigators main hypothesis is that patients randomised to the HIE-program~     will achieve higher energy expenditure during rest and physical activity after treatment than~     those allocated to the MIE-programme. In addition, the investigators hypothesise that the~     HIE-group will achieve a better health related quality of life than the MIE-group after~     treatment. The investigators also hypothesize that inter-individual variability in adaptation~     to the two training regimens may be due to genetic factors. If the investigators hypotheses~     are confirmed, this project might have beneficial clinical implications for future obesity~     treatment strategies.~   "
95912|NCT02311725|"~     The overall aim of this program of research is to refine and test a newly developed~     storytelling video intervention (sTVi) for depressed primary care patients.~      The purpose of the proposed project is to establish the feasibility, acceptability, and~     preliminary effects of the intervention for an eventual large-scale randomized clinical trial~     which would test the efficacy of sTVi in comparison to a control condition.~      To achieve the specific aims, the investigators will conduct a pilot randomized clinical~     trial (n = 40), with two treatment arms: antidepressant treatment as usual (aTAU) + sTVI vs~     aTAU + attention control videos.~   "
95913|NCT02311712|"~     The aim of this study is to assess the effects of implementation of a non-endoscopic~     esophageal cancer-screening program on outcomes of interest in an asymptomatic high-risk~     population in Golestan Province, Iran. Study population will be recruited in two arms. In the~     intervention arm, cytological examination of the esophagus will be performed using a capsule~     sponge device. Subjects in the control arm will receive no intervention. All participants~     will be followed for 5 years. The outcomes of interest, including the incidence of esophageal~     cancer as well as mortality rates, will be compared between the two groups.~   "
95914|NCT02311699|"~     Violence against women (VAW), the most extreme manifestation of the unequal power balance~     between women and men, is a major global public health concern. One of the most common forms~     of VAW is that perpetrated by a husband or other intimate partner. In Ethiopia, 70.9% of~     women reported having experienced physical and/or sexual intimate partner violence (IPV) in~     their lifetime, demonstrating the pervasiveness of the problem. A growing body of evidence~     has also linked IPV and HIV risk.~      This study is a cluster randomized controlled trial assessing the impact of a community-based~     intervention focused on Intimate Partner Violence and HIV delivered in the context of the~     Ethiopian coffee ceremony, a culturally established forum for community discussion and~     conflict resolution. Villages will be randomly assigned to one of 4 study arms (3~     intervention and one control arm): 1) Women only participate in the intervention, 2) Men only~     participate, 3) Both men and women (couples) participate, 4) Women and men receive the~     control intervention comprising a short informational session on violence reduction.~   "
95915|NCT02311686|"~     The aim of the study is to study the profile of ethanol and non-oxidative biomarkers (ethyl~     glucuronide, ethyl sulphate and fatty acid ethyl esters) after experimental administration of~     increasing doses of alcohol in adult subjects.~   "
95916|NCT02311673|"~     The purpose of this study is to evaluate the effects of a once daily subcutaneous (SC)~     injectable formulation of RM-493 in obese subjects with Prader-Willi syndrome on~     tolerability, weight loss and hyperphagia-related behavior. The study drug (RM-493 and~     placebo) will be administered in a blinded fashion.~      Funding Source - FDA OOPD~   "
95917|NCT02311660|"~     This is an open label interventional study using an implantable vagus nerve stimulation~     device in patients with Crohn's disease who have active disease despite treatment with a~     tumor necrosis factor (TNF) antagonist drug.~   "
95918|NCT02311647|"~     The aim of this multi-center study is to assess the effects of Tamoxifen on the uterine~     cavity and endometrial abnormalities in young premenopausal women diagnosed with breast~     cancer.~      The research contains two parts: a clinical study and a laboratory study.~        -  Clinical part: to evaluate the association between tamoxifen treatment and uterine~          abnormalities.~        -  Laboratory part: to investigate the effect of Tamoxifen treatment on endometrial tissue,~          by exploring the molecular aspect of endometrial receptivity.~   "
95919|NCT02311634|"~     The purpose of this study is to determine whether electrical pudendal nerve stimulation is~     more effective than transvaginal electrical stimulation in treating urge urinary incontinence~     (UUI).~   "
95920|NCT02311621|"~     Patients with recurrent or refractory neuroblastoma are resistance to conventional~     chemotherapy. For this reason, the investigators are attempting to use T cells obtained~     directly from the patient, which can be genetically modified to express a chimeric antigen~     receptor (CAR). The CAR enables the T cell to recognize and kill the neuroblastoma cell~     through the recognition of CD171, a protein expressed of the surface of the neuroblastoma~     cell in patients with neuroblastoma. This is a phase 1 study designed to determine the~     maximum tolerated dose of the CAR+ T cells.~   "
95921|NCT02311608|"~     To observe and access the Effects and safety of terlipressin or high dose~     somatostatin/octreotide when usual dose somatostatin/octreotide fail to achieve hemostasis in~     patients with acute variceal bleeding.~   "
95922|NCT02311595|"~     The purpose of this study is to determine if reduced port totally laparoscopic distal~     gastrectomy with complete D2 lymph node dissection for gastric cancer is safe and oncological~     feasible.~      67 patients with gastric cancer with preoperative staging from T1 to T3 will undergo reduced~     port totally laparoscopic distal gastrectomy.~      The primary end point of this study is to measure compliance rate with pathology report and~     compare with previous compliance rate data.~   "
95983|NCT02310802|"~     The primary objective of this study is to assess the increase in clinical pregnancy rate~     after administration of a range of single oral doses of OBE001, an oral oxytocin antagonist,~     compared to placebo.~   "
95924|NCT02311569|"~     The aim of this phase II study is to test a novel concept in the treatment of patients with~     myeloproliferative neoplasms (MPN), a disease of the bone marrow. With no current cure~     available, MPN are a group of chronic leukemias (blood cancers) in which patients produce too~     many blood cells. These increased blood cell numbers cause problems to the patient such as~     bleedings or thrombosis and some patients may progress to acute leukemia, a life threatening~     condition. Most MPN patients have a gene mutation called JAK2-V617F. The disease is~     maintained by mutant MPN stem cells that reside in the bone marrow in specialized locations~     called niches. These niches need connections to the nervous system. New findings show that~     these connections are destroyed by the presence of the mutated MPN stem cells. Research teams~     found that some drugs (beta3-sympathicomimetics) can restore these damaged niches and at the~     same time reduce the MPN disease manifestation in a mouse model of MPN. Such~     sympathicomimetic drugs are already being used to treat patients with asthma or hyperactive~     bladder. These drugs have shown to have only few side effects. The study tests the effects of~     the beta-3-sympathicomimetic drug Mirabegron (Betmiga®) on MPN disease in 39 patients that~     carry a JAK2-V617F mutation. The hypothesis is that Mirabegron will have a beneficial effect~     on bone marrow niche cells and will thereby improve the disease manifestation in MPN~     patients. This study should provide a rapid answer whether targeting the nervous system of~     the niche cells could be useful for patients with MPN and warrants to be tested in larger and~     more long-term studies.~   "
95925|NCT02311556|"~     This study is designed to evaluate whether advanced magnetic resonance imaging (MRI)~     techniques such as dynamic susceptibility-weighted contrast-enhanced perfusion MRI may be~     used to predict treatment response of brain metastasis after radiosurgery.~   "
95926|NCT02311543|"~     Axillary lymph node dissection remains an integral part of surgical treatment of primarily~     node-positive invasive breast cancer. In order to reduce the incidence of clinically relevant~     seroma, a suction drain is routinely placed into the axillary cavity after axillary lymph~     node dissection (ALND) by a separate stab incision. The pathogenesis of seroma involves the~     collection of lymph fluid caused by dissection of lymph vessels and exudate. All coagulation~     and fibrinolytic factors are produced and secreted by lymphatic endothelial cells and are~     involved in the sealing of lymphatic capillaries. Local hemostyptic agents may therefore~     reduce postoperative secretion from lymphatic fistulas caused by ALND.~      We propose to conduct a multicenter prospective randomized control trial in Switzerland to~     evaluate the impact of TachoSil®, a ready-to-use, absorbable surgical patch (consisting of an~     equine collagen sponge coated with human fibrinogen and human thrombin) on axillary drainage~     after ALND for breast cancer. We hypothesize that the use of TachoSil® significantly and~     relevantly reduces the volume and duration of axillary drainage after ALND. This has the~     potential to increase patients' quality of life, as well as to shorten the length of hospital~     stay and reduce hospital costs.~   "
95927|NCT02311530|"~     The study was conducted as an open-label, balanced, randomized, two-treatment, two-period,~     two-sequence, single-dose, crossover, bioequivalence study comparing felodipine extended~     release tablets USP 10 mg (containing felodipine 10 mg) manufactured by OHM Laboratories~     Inc., NJ, 08901 with PLENDIL® extended release tablets 10 mg (containing felodipine 10 mg)~     manufactured by Merck & Co. Inc. Whitehouse Station, NJ 08889 USA for AstraZeneca LP~     Wilmington, DE 19850 in healthy, adult, male, human subjects under fed condition.~   "
95928|NCT02311517|"~     Postoperative pain still remains a challenging problem in patients undergoing video-assisted~     thoracoscopic surgery (VATS). However, there is no gold standard for regional analgesia for~     VATS. Serratus anterior plane block (SPB) under ultrasound guidance has been described~     recently to achieve complete paresthesia of the hemithorax. Therefore, SPB has the~     possibility to provide analgesia following thoracic surgery. Pain following surgery is a~     critical side effect of surgery, which increases the risk of complications and delays a~     recovery. Therefore, SPB may help not only reduce pain following VATS, but also increase the~     quality of recovery. This study aims to investigate the effectiveness of ultrasound-guided~     SPB on the quality of recovery and pain in patients undergoing VATS.~   "
95929|NCT02311504|"~     In patients with confirmed diagnosis of diabetes, an eye examination and a comprehensive~     survey are conducted after recruitment in secondary diabetes care centers. All patients~     undergo a comprehensive eye examination including wide-angle fundus photograph and ocular~     cohaerence tomography. A questionnaire assesses the characteristics (history: diabetes~     duration, type of treatment), knowledge and personal attitudes of the persons affected. The~     relevant lab findings were collected from the electronic files.~      Main focus of the study is the concordance to the national screening recommendations (last~     eye exam, presence of retinopathy).~   "
95930|NCT02311491|"~     Purpose: The project aims to assess if hard ceramic coatings on orthodontic archwires will~     reduce the sliding resistance of archwires in the brackets during orthodontic treatment~     procedures.~      Participants: Up to 80 subjects will be recruited for this study. Subjects between 10 years~     of age and 45 years old will be otherwise healthy subjects previously diagnosed with~     malocclusion.~      Procedures (methods): Each subject will receive an experimental (coated) or a regular~     (uncoated control) orthodontic archwire (AW) for a 3-month treatment. The 3D digital images~     of each subject's dentition will be recorded three times at 0-, 6- and 12-week visits. The AW~     will be removed and retrieved after the 3-month trial.~   "
95931|NCT02311478|"~     This study aims to use validated tools as well as new technology to examine changes in~     bleeding patterns among women who are initiating the copper T380A IUD.~   "
95932|NCT02311465|"~     The purpose of this research study is to find out whether it is better to introduce cancer~     patients to the palliative care team at a later date when there is a specific issue or~     problem or to introduce cancer patients to the palliative care team when first diagnosed~     before any specific issue or problem occurs.~   "
95984|NCT02310789|"~     Clinical studies of lumacaftor + ivacaftor (combo therapy) produced better FEV1 (forced~     expiratory volume in 1 second) improvements than ivacaftor alone, without further improvement~     in sweat chloride results.~      To help understand why sweat chloride was unresponsive, the investigators will use a newly~     developed sweat secretion test that provides accurate, in vivo readout of CFTR (cystic~     fibrosis transmembrane conductance regulator) function in the sweat gland secretory coil.~      The investigators devised a protocol to determine if short courses of ivacaftor (3.5 days)~     will produce significant increases in WT (Wild-Type, i.e. normal) CFTR open probability by~     measuring CFTR-dependent sweating (C-sweat) in subjects with WT CFTR.~   "
95933|NCT02311452|"~     Some children get serious bacterial infections that require hospitalization and then a long~     course of antibiotics to completely treat the infection. Examples of these serious infections~     include ruptured appendicitis (when the appendix gets inflamed and bursts, releasing bacteria~     into the abdomen), complicated pneumonia (when an infected pocket of pus forms either in the~     lung or between the lung and chest wall), and osteomyelitis (an infection of the bone). To~     extend the duration of antibiotic therapy after discharge from the hospital, doctors will~     often insert a long catheter called a PICC line in the child's vein, which can stay in the~     body for several weeks. However, PICC lines require a fair amount of maintenance and training~     of caregivers in their use, require children to restrict their activities, and can lead to~     serious complications, such as blood stream infections and clots. An alternative to PICC~     lines is extending the duration of antibiotic therapy with oral antibiotics (pills or syrup)~     that achieve high levels of medicine in the blood and do not have the extra work,~     inconvenience and risks of PICC lines. Unfortunately, there are very few high quality studies~     that have demonstrated that oral antibiotics are just as good as intravenous antibiotics~     delivered via a PICC line, and so many doctors still recommend the PICC line treatment~     option. Also, no studies have been done to compare the impact of these two treatment options~     on the quality of life of the child and their caregivers.~      In this proposal the investigator outline a series of projects to compare oral antibiotics~     vs. intravenous antibiotics delivered via a PICC line in children who require prolonged (at~     least 1 week) home antibiotic therapy after hospitalization for three different serious~     bacterial infections: ruptured appendicitis, complicated pneumonia, and osteomyelitis. To see~     whether oral antibiotics are just as good as PICC lines, the investigators will use data~     collected from over 15,000 children with one of these three infections who were hospitalized~     at one of 43 US children's hospitals during the years 2009-2011, and determine whether PICC~     lines resulted in fewer rehospitalizations for treatment failure than oral therapy.~   "
95934|NCT02311439|"~     This prospective cohort, phase II, trial is studying induction chemotherapy combination,~     FOLFIRINOX regimen, consisted of oxaliplatin, irinotecan, leucovorin and fluorouracil (5-FU),~     for 4 cycles, followed by consolidation concurrent radiotherapy with capecitabine in~     non-progressed cases, in treating patients with locally advanced cancer pancreas.~   "
95935|NCT02311426|"~     The study is a comparative effectiveness study with comparision of two cohorts of patients~     with stroke in North of Norway and in Denmark. At baseline information is collected from the~     stroke registries in both countries. Time points for follow up are at 3 and 12 months~     post-stroke. Data are collected from medical charts and with use of telephone interview in~     addition to self-report questionnaires. The study will provide information about mortality,~     functional status and quality of life. Information about rehabilitation services in both~     countries are collected and compared, and analysed in relation to patients outcome.~   "
95936|NCT02311413|"~     The goal of this study is to identify changes in cells that are related to the treatment with~     Cat-PAD (ToleroMune Cat).~   "
95937|NCT02311400|"~     Background:~      - People respond differently to life events and how those events make them feel. They also~     respond differently to information about the how their actions affect their lives and health.~     Researchers want to learn more about these differences. In this study, researchers will look~     at how people respond to an event in their life. Researchers will also look at how people~     respond to information about how their actions can affect their health.~      Objective:~      - To see how people respond differently to life events and information about alcohol and~     breast cancer.~      Eligibility:~      - Women 18 and older who have never been diagnosed with cancer and who drank 5 or more~     alcoholic drinks in the past week.~      Design:~        -  This study will take place online.~        -  Participants will be randomly assigned to 1 of 10 groups.~        -  Researchers will ask participants to take part in 2 small studies, 1 about Life Events~          and 1~      about Alcohol and Breast Cancer.~        -  In the Life Events study, participants will write briefly about a time they felt very~          happy, fearful, angry, or surprised, or they will write about a room in their house.~          Then they will answer questions about that event. They also will write about a value~          that is or is not important to them.~        -  In the Alcohol and Breast Cancer study, participants will read a health message about~          the link between alcohol and breast cancer. Then they will answer questions about what~          they read and give their thoughts about alcohol and breast cancer.~        -  Both studies should take about 30 minutes.~   "
95938|NCT02311387|"~     Background:~      - Lassa fever is very similar to other diseases that cause fever, such as malaria and yellow~     fever. People get Lassa fever from mice. A person can get Lassa fever from mice urine and~     droppings. When a group of researchers tested the mice in Soromba, Mali, they found that many~     were infected with Lassa fever. Lassa fever may also be passed through body fluids (like~     blood or semen) of people infected with Lassa fever. Researchers want to study this disease~     to help the government better protect the health of people in Sibirila.~      Objectives:~      - To find out how many people in Sibirila have ever had Lassa fever. Also, to measure how~     many people get the disease every year.~      Eligibility:~      - People age 6 months and older who are residents of Soromba, Bamba, or Banzana with no plans~     to relocate within 1 year.~      Design:~        -  Households will be randomly selected to participate in the study.~        -  Participants will have up to 20 drops of blood collected from the finger or heel.~        -  Participants will be asked about their age. They will be asked if they have ever had a~          fever and if they have ever seen mice in or around their home.~        -  Researchers will come back in 1 year and take another drop of blood from the~          participant. Participants will be asked the same questions.~        -  If a participant has a fever at any time during the year, he or she should go to the~          health center. Researchers~      will collect a few drops of blood to test for Lassa fever.~   "
95939|NCT02311374|"~     Background:~      - The glymphatic system helps keep harmful waste from building up in the brain. Researchers~     think it is more active in people during sleep than while awake. They want to study the~     glymphatic system using magnetic resonance imaging (MRI).~      Objective:~      - To see if there are differences in the way waste is removed from the brain while a person~     is sleeping versus awake.~      Eligibility:~      - Healthy people age 18-60.~      Design:~        -  This study is in 2 parts.~        -  For the technical part (discontinued), participants will be screened with medical~          history and physical exam. They will have urine and breath alcohol tests.~        -  Participants will have 2 MRI scans. Before the scans, they will have urine and breath~          alcohol tests, and complete a questionnaire.~        -  For MRI, participants will lie on a table that slides in and out of a metal cylinder. A~          device will be placed over their head. They will lie still for up to 20 minutes at a~          time. They may be asked to stay awake or fall asleep for up to 2 hours at a time.~        -  For the research part, participants will be screened with medical history and physical~          exam. They will have urine and breath alcohol tests. For 1 week they will wear a device~          that monitors their activity and sleep.~        -  Participants will stay at NIH overnight. They will give a blood sample, have urine and~          breath alcohol tests, and complete a questionnaire.~        -  Participants will take memory, concentration, and thinking tests.~        -  Participants will have 3 MRI scans. An electroencephalography machine will record their~          brain activity. Electrodes will be placed on their scalp.~   "
95940|NCT02311361|"~     Background:~      - Stereotactic body radiation therapy (SBRT) is used to treat cancer. It is a way of giving~     very focused beams of radiation to tumors. Researchers think that the drugs being used in~     this study might work better when combined with SBRT in people with pancreatic cancer.~      Objective:~      - To study the safety and effectiveness of MEDI4736 and/or tremelimumab with SBRT.~      Eligibility:~      - People 18 and older who have pancreatic cancer that has not responded or to chemotherapy.~     They must be candidates for radiation but not resection.~      Design:~        -  Participants will be screened with medical history and physical exam. They will have~          blood tests. Their tumor will be measured using computerized tomography (CT) or magnetic~          resonance imaging (MRI).~        -  Participants will have their tumor biopsied with a needle. They will have also have a~          biopsy after cycle 1.~        -  Participants will get 1 or 2 drugs in combination with the SBRT.~        -  For MEDI4736, the duration of each cycle will be 28-days. Participants will get the drug~          through an intravenous (IV) infusion twice in each cycle (Days 1 and 15).~        -  For tremelimumab, the duration of the first 6 cycles will each last 28 days. Then the~          duration of the last 3 cycles will change to 12 weeks. Participants will get the drug~          through an IV once in each cycle.~        -  All participants will have SBRT. Some will get 1 dose of radiation and some will get 5.~          CT scans will map their tumor.~        -  Participants will have medical history, physical exam, and blood tests in each cycle.~          They will have a CT scan or MRI every 8 weeks. Cycles will continue for up to 12 months.~        -  Participants will be contacted yearly for follow-up.~   "
95941|NCT02311348|"~     Background: In a liver biopsy, a small piece of liver is removed. A percutaneous liver biopsy~     (PLB) is done through a needle on the right side of your belly. In a transjugular liver~     biopsy (TLB), the right side of the neck is numbed and a straw-like tube is put in. The tube~     goes down to your liver and a piece of liver is removed. Researchers want to learn more about~     the pain people feel after each of these procedures.~      Objectives: To compare whether there is more pain associated with the PLB versus TLB.~      Eligibility: Adults 18 years or older enrolled in a separate protocol (91-DK-0214) for liver~     biopsy. They must be able to read, write, and speak English.~      Design: Under the separate protocol (91-DK-0214), participants will be screened and have a~     liver biopsy.~      Before the biopsy, participants will give their medical history. They will answer questions~     about past surgeries and how they feel about pain.~      Participants will have a pain test with a device called a dolorimeter. They will sit up with~     their feet on the ground, and put their thumbs on a table. They will feel pressure on each~     thumb until it they say it is painful.~      Before the biopsy and 2, 4, and 6 hours after the biopsy, they will answer pain questions.~   "
95942|NCT02311335|"~     Background:~      - Genes are the instructions our body uses to function. Researchers can look for changes, or~     variants, in the genes. The goal of this study is to find new gene changes that lead to lipid~     disorders. Older research methods looked at one or a few genes at a time. Genomic sequencing~     looks at most of the genes at once. Genomic sequencing may find the cause researchers haven t~     been able to find from past methods.~      Objectives:~      - To better understand genetic causes of lipid disorders through genomic sequencing.~      Eligibility:~      - People age 2 and older with unusual lipid disorders, and their relatives.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will have~          blood taken. They may give a saliva sample.~        -  Based on the screening test, researchers will chose 3 5 family members to perform the~          genomic sequencing. The sequencing will be done on a sample of DNA collected during the~          blood draw and saliva sample.~        -  Participants may be invited to take part in other protocols that may involve imaging of~          their heart or blood vessels. They do not have to participate. If they do, they will~          sign a separate consent for those tests.~        -  If a participant s family member cannot travel to the NIH, the NIH documents and consent~          will be reviewed during a teleconference. A blood or sputum kit will be mailed to them.~   "
95943|NCT02311322|"~     Background:~      - Some growth disorders are caused by a change in genes. Genes are the instructions the body~     uses to function. Changes in genes often cause them not to work correctly. Researchers want~     to use a new technology called exome sequencing, to look at many genes at once. This is done~     by looking at DNA from blood or saliva in a lab. This method may help find the cause of~     disorders that researchers haven t been able to find using past methods.~      Objectives:~      - To better understand genetic causes of growth disorders.~      Eligibility:~      - Children and adults with growth disorders and their family members.~      Design:~        -  Participants will give a small sample of blood and/or saliva.~        -  Researchers will purify DNA from the sample. They will perform exome sequencing and~          other tests to look for changes in genes. Some participants may receive limited or no~          genetic tests. Researchers will let them know if exome sequencing is performed.~        -  Participants may have a medical history, physical exam, and lab tests. They may have~          x-rays or ultrasound tests to study the disorder in their family.~        -  Some participants may be recommended for a specific genetic test from a commercial lab.~          They may have to pay for that test.~        -  Participants will be told about test results that relate to the growth disorder. This~          may happen up to years after the testing. They may have to give another blood and/or~          saliva sample.~        -  Some participants may get results about other health conditions. This will only happen~          if the information would help the person or their family protect their health. They may~          have to give another blood and/or saliva sample.~   "
95944|NCT02311309|"~     Peroperative bleeding has been studied in specific populations exposed to bleeding (i.e.~     cardiac surgery, orthopedic surgery). Epidemiology of peroperative bleeding and transfusion~     remain poorly studied in the whole cohort of patients scheduled for surgery remain unknown.~     The investigators conducted a prospective study in order to examine the incidence, and risk~     factors associated with peroperative bleeding and transfusion.~   "
95945|NCT02311296|"~     Ventilator associated pneumonia (VAP) is common problem among ICU patients and major source~     of infection among patients receiving mechanical ventilation. Patients on mechanical~     ventilation accumulate secretion leading to aspiration of infected secretions. Using new~     generation endotracheal tube (Hi-Lo tube) can reduce the incidence of VAP.~   "
95946|NCT02311283|"~     The purpose of this study is to determine if patients participating in The Longitudinal~     Study of Urea Cycle Disorders are different than participants in the Urea Cycles Disorders~     Consortium (UCDC) Rare Diseases Clinical Research Network (RDCRN) Contact Registry and to~     determine if patients are a good source of medical information.~   "
95951|NCT02311218|"~     In February 2013, 44 healthy adults was recruited and randomized to daily intake of lozenges~     with or without Lactobacillus reuteri strains DSM 17938 and PTA 5289 for 12 weeks. The effect~     of these Lactobacillus reuteri strains on the oral microbial composition was monitored~     before, after 4, 8 and 12 weeks and after 1 and 6 months after exposure was completed. For~     this purpose saliva and tooth plaque was collected. Of 44 included subjects, 41 completed the~     study. The used Lactobacillus reuteri containing lozenges are commercially available and~     identical placebo lozenges was obtained from the manufacturer. The study product was well~     tolerated with no observed side effects. Compliance was excellent.~      The investigators' primary outcome was to determine whether daily intake of Lactobacillus~     reuteri strains DSM 17938 and PTA 5289 for 12 weeks alters the tooth colonizing bacterial~     plaque composition determined by a multiplex sequencing technique. Effects are put in~     relation to general knowledge on bacterial profiles associated with risk to develop dental~     caries and periodontitis.~   "
95952|NCT02311205|"~     This study is a phase II, prospective, open-label, single arm, single center study of the~     efficacy and safety of concurrent conventional transarterial chemoembolization (TACE) and~     sorafenib in patients with hepatocellular carcinoma and extrahepatic metastasis. All of the~     55 patients with hepatocellular carcinoma and newly diagnosed extrahepatic (lung, bone, lymph~     node, adrenal gland) metastasis will be included.~      On demand conventional TACE will be performed in all the patients after enrollment and can be~     continued until intrahepatic CR, TACE failure or consent withdrawal. Sorafenib will be~     started 3-7 days after the first and each subsequent TACE and stopped one day before next~     TACE and will be continued until sorafenib failure, consent withdrawal or condition worsening~     by clinical decision. Repeated on-demand TACE and sorafenib should continue until the~     criteria for treatment discontinuation are met. After initiation of sorafenib combination~     treatment, patients will be seen and will perform routine examination at week 4 and, after~     then routine examination will be followed every 6 ± 2 weeks.~   "
95953|NCT02311192|"~     This study is aimed at creation and validation of a vitreous haze scoring system using~     ultrasonography B-scan of the eye. Images will be obtained from patients with uveitis and~     quantification of inflammation will be done to create the scoring scale.~   "
95954|NCT02311179|"~     This study focuses on the effect of the hydroxyapatite coating with BoneMaster on the~     fixation of the hip prosthesis in primary hip alloplasty. A hemispheric joint cup of the type~     Exceed cup (Biomet) characterized by a porous surface of titanium plasma spray is used. The~     surface is coated with hydroxyapatite deposited electrochemically (BoneMaster) and will be~     compared with an identical cup without hydroxyapatite.~   "
95955|NCT02311166|"~     Introduction: The lack of congruence between the acetabulum and femoral head in hip dysplasia~     compromise the passive stability of the hip joint resulting in increased stress on the~     acetabular labrum, joint capsule and the muscles acting close to the hip joint. Soft tissue~     injury is present in hip dysplasia, and pathology of the iliopsoas muscle has been found in~     18-50%. To our knowledge, no studies have systematically examined the prevalence of soft~     tissue pathology in hip dysplasia.~      The overall aim of this research project is to examine soft tissue pathology in 100 patients~     with hip dysplasia prior to and one year after Periacetabular osteotomy (PAO).~      Methods: Soft tissue pathology will be examined in a prospective cohort study on 100 patients~     with hip dysplasia prior to and one year after surgery. Pathology will be examined using~     ultrasonography and the Clinical Entities Approach that focus on pathology of the iliopsoas,~     adductors, rectus abdominis, gluteus medius and hamstrings. Furthermore, hip muscle strength~     is tested with a dynamometer, hip related health is measured with the Copenhagen Hip and~     Groin Outcome Score (HAGOS) and physical activity is measured with triaxial accelerometers~     during a period of 7 days.~      Perspective: Is it possible to demonstrate pathology of the hip muscles and tendons applying~     clinical tests, muscle strength tests, and ultrasonography, as it has been found in~     sports-active people with groin pain, it will make sense to plan and test a specific training~     program focusing on the pathological soft tissue pathology.~   "
95956|NCT02311153|"~     Laryngeal mask airways (LMA) have been shown to be a safe mode of airway management when~     delivering general anesthesia to patients during a variety of operative procedures. LMA's~     have been studied in a wide range of otolaryngologic procedures, and are generally safe and~     accepted by both anesthesia providers and surgeons alike. This study will aim to demonstrate~     the safety and efficacy of LMA for airway management during sinonasal surgery by directly~     comparing them to endotracheal intubation in a prospective randomized single‐blind study.~   "
95957|NCT02311140|"~     The aim of the proposed trial in assessment of effects of Kalydeco™ treatment on sinonasal~     involvement in CF patients with at least one mutation of G551D receiving a new therapy with~     the CFTR potentiator. The focus will be given on changes in epithelial lining fluid~     inflammatory markers from CF upper airways sampled by nasal lavage.~      The program is subdivided into a part A assessing inflammatory markers in NL and sinonasal~     symptoms longitudinally from pre-treatment to months with the new therapy.~      Part B will only be performed in a smaller subgroup and assess inflammatory markers in NL~     every second day in the first month of treatment and then every week until the end of month 3~     with Kalydeco™ therapy.~   "
95958|NCT02311127|"~     Peripherally inserted central catheters (PICCs ) are used for the administration of~     intravenous fluids and for blood sampling. PICCs may remain in place for weeks to months and~     are safeguarded from migration or accidental dislodgement by securement devices. Different~     types of these devices are available. StatLock® (C.R. Bard) is a stabilization device with an~     adhesive anchor pad. The catheter wings of the PICC must be placed over the posts then the~     system is closed with gull-wings . StatLock® has to be changed weekly. Healthcare providers~     have to pay attention to prevent accidental catheter dislodgement during the renewal~     procedure. SecurAcath® (Interrad Medical) is a new securement device to the European market.~     The device uses a small subcutaneous anchor to secure the PICC. One of the advantages~     compared to adhesive stabilization devices, is a reduction in maintenance time by simplifying~     dressing changes and subsequently staff time. It is described that nurses report that care is~     left undone due to low staffing levels. Therefore, investigation of nursing time savings with~     the support of technology is imperative. SecurAcath® remains in place for life of the PICC~     and therefore has the potential to reduce the time for dressing change as there is no need~     for weekly device change. The objective of this study is to measure nursing time for dressing~     change and explore inserting and removal issues and patient experiences.~   "
95959|NCT02311114|"~     This study will evaluate the Telehomecare (THC) Program offered to patients with heart~     failure or chronic obstructive pulmonary disease across the Central West, Toronto Central and~     North East Local Health Integration Networks in Ontario. It will explore the opinions and~     experiences of patients, providers, technicians and administrators involved with THC Program~     in order to provide stakeholders with information about the processes and organizational~     factors impacting the program's adoption, the experiences of its participants, impact on~     patient outcomes, costs to the health-care system and who is benefiting the most from~     participating. These factors will be determined using semi-structured interviews, surveys,~     and observation of practices of everyone involved with THC. The study will also evaluate~     patient data to determine changes in patients' utilization of healthcare services.~   "
95960|NCT02311101|"~     The study aims to establish the safety and toxicity of a combined intravesical mitomycin C~     with BCG for patients with bladder cancer.~   "
95961|NCT02311088|"~     Ticagrelor treatment is associated with increased rates of dyspnea, where previous studies~     have implied a possible role of adenosine. The purpose of this study is to determine if the~     caffeine-antagonist is effective in reducing dyspnea related to ticagrelor.~   "
95962|NCT02311075|"~     Endothelial dysfunction of conduit arteries plays an important role in the development of~     cardiovascular complications associated with type 2 diabetes. In order to propose targeted~     therapeutic approaches, this study aim to determine the mechanisms involved in endothelial~     dysfunction of conduit arteries in these patients.~   "
95963|NCT02311062|"~     This investigation is aimed to examine the effects of two different exercise-oriented~     protocols on the knee torque-angle relationship of the knee flexors.~      Thirty two young soccer players were be randomly assigned to three groups:~     hamstring-eccentric (ECC, n=11), unstable-squatting (UNS, n=11) or control (C, n=10). The ECC~     and UNS groups performed eighteen sessions over 6 weeks of an injury prevention protocol,~     using only 3 hamstring-eccentric or unstable-squatting exercises. The angle-torque~     relationship was measured before and after the training intervention. Voluntary isometric~     torque was recorded at six test angles, with participants prone (35º-100º; 0º on full~     extension).~   "
95964|NCT02311049|"~     External beam radiotherapy (RT) is one of the standard curative treatment options for~     patients with prostate cancer (PC). Several randomised trials have shown excellent long-term~     biochemical outcome with higher radiation doses. Nowadays, RT for PC commonly consists of~     delivering 74-80 Gy in 2 Gy fractions, resulting in an overall treatment time of 7-8 weeks.~     The sensitivity of different tissues to fractionation changes can be quantified through the~     alpha/beta ratio in the linear-quadratic model. Dose-response analysis of PC patients treated~     with both external beam RT and brachytherapy has led to the hypothesis that the alpha/beta~     ratio of PC is lower than for most other tumors and approaches a value characteristic of late~     responding tissues. Values between 1.2 and 3.9 Gy have been calculated. If the alpha/beta~     ratio of PC is indeed low, then hypofractionating RT treatments can theoretically maintain~     high bioequivalent tumor doses, shorten overall treatment time and decrease late~     toxicities.The advantages in terms of patient convenience and treatment cost are obvious.~     There is level I evidence that shows that hypofractionated radiotherapy schedules have at~     least equivalent biochemical outcome with only a small increase in acute but not late~     toxicity when compared to conventional fractionation RT schedules.~      Results on different hypofractionation schedules have been reported, however the optimal~     hypofractionation is not clear so far. In this randomised trial we would like to compare 2~     different radiotherapyschedules: 16 fractions à rato of 4 fractions a week versus 25~     fractions à rato of 5 fractions a week. The incidence on acute toxicity and early late~     toxicity (i.e. within 2 year post radiotherapy) and the impact on quality of life will be~     registrated and compared. The study will be performed in 2 stages. For stage 1, sample size~     was calculated to rule out an upper limit of 40% of patients with RTOG grade 2 or worse bowel~     (GI) complications with an expected rate of 25%, based on a one-stage Fleming-A'Hern design.~     A power of 83.0% (alpha level 0.038 one-sided) was obtained when including 72 patients per~     group (144 patients in total). If 22 or more patients out of 72 had grade 2 or worse GI~     complications, then the study arm was to be rejected. To allow for a dropout of 10%, 160~     patients were included in stage 1. Sample size for stage 2 was calculated analogously~     allowing ruling out an upper limit of 35% of patients with RTOG grade 2 or worse GI~     complications with an expected rate of 25%. When including 155 patients per group (310 in~     total) a power of 85.7% (alpha level 0.049 one-sided) was obtained. If 45 or more patients~     out of 155 had grade 2 or worse GI complications, then the study arm was to be rejected. The~     sample size for stage 1 and stage 2 combined was set at 346 (173 per group), with a 10%~     allowance for dropout.~   "
95965|NCT02311036|"~     The purpose of the study is to investigate the effects and outcome predictors on functional~     recovery after comprehensive rehabilitation for post-acute care -cerebrovascular diseases.~   "
95966|NCT02311023|"~     This is an open trial of intermittent fasting in a group of patients with refractory~     seizures. Patients will continue on the diet for 6 months to assess the impact of the diet on~     seizure frequency.~   "
95967|NCT02311010|"~     To optimize the Advagraf (tacrolimus once a day) initial daily dose used in de novo after~     kidney transplantation in combination with MMF (or MPA) and corticosteroids (CS) regarding of~     the genetic Cyp 450 3A5 polymorphism of the recipient.~      The study of the tacrolimus through level (ng/ml) determines if the therapeutic level is~     reached.~   "
95968|NCT02310997|"~     This trial is looking at using umbilical cord blood from unrelated donors after high dose~     chemotherapy. It is for people who have cancer of the bone marrow or lymphatic system~     including leukaemia and lymphoma, or a blood disorder called myelodysplastic syndrome (MDS).~      The trial is for babies over 4 weeks old, children, and adults up to the age of 45.~   "
95969|NCT02310984|"~     This project which is fully funded by the European Union FP7 Program is designed to pull~     together all the information we obtain from scans and x-rays to design a personalised 3-D~     digital model of each patient, their anatomy and disease. We can then use this as follows: as~     (i) an aid to surgical planning to enable objective clinical decision making (ii) a decision~     support tool to communicate the available treatment options to the patient and facilitate~     shared decision making and provision of personalised care and (iii) to enable standardised~     objective evaluation of the aesthetic outcome of the treatment procedures. This study aims to~     demonstrate the ability of the Virtual Physiological Human concept to empower breast cancer~     patients and assess the impact on their care and quality of life.~   "
95970|NCT02310971|"~     The purpose of this study is to assess the safety and tolerability of CVac, an~     investigational cell therapy, in patients with resected stage I or II adenocarcinoma of the~     pancreas who have completed surgery with or without front-line chemotherapy or radiation~     therapy.~      After confirmation of non-measurable disease patients will undergo leukapheresis for~     manufacture of the study agent.~   "
95971|NCT02310958|"~     The investigators plan a retrospective, single-center outcome analysis of laparoscopic hernia~     repair in children operated between March 2nd, 2010, and March 1st, 2014. Data analysis will~     be based on a review of hospital records and a questionnaire answered by families. Patient~     demographics (age, gender), affected side, type and duration of laparoscopic intervention,~     and outcome parameters (hernia recurrence, post-operative complications, eg. infections,~     length and type of postoperative pain medication, and length of the postoperative hospital~     stay) will be analysed.~   "
95972|NCT02310945|"~     Pain is the dominant symptom of knee osteoarthritis and recent evidence suggests factors~     outside of local joint pathology, such as pain sensitization, can contribute significantly to~     the pain experience. It is unknown how pain sensitization influences outcomes from commonly~     employed interventions such as physiotherapy.~      The aims of this study are, firstly to identify people with knee OA who display signs and~     symptoms associated with pain sensitization using clinical tools and quantitative sensory~     testing. Secondly, we will investigate if indications of pain sensitization at baseline are~     associated with poor outcome following physiotherapy.~      Methods and analysis:~      This is a multi-centre prospective cohort study with 140 participants. Eligible patients with~     moderate/severe symptomatic knee osteoarthritis will be identified at hospital outpatient~     clinics. A baseline assessment will provide a comprehensive description of the somatosensory~     characteristics of each participant by means of clinical examination, quantitative sensory~     testing and validated questionnaires measuring pain and functional capacity. Participants~     will then undergo physiotherapy treatment, in line with current clinical guidelines.~     Follow-up post physiotherapy treatment (estimated to be at 3 months) will assess pain,~     disability (sub-scales of Western Ontario and McMasters University Score Osteoarthritis~     Index) and participants' global rating of change. These primary outcome measures will~     dichotomise participants into treatment 'responders' and 'non-responders' according to the~     Osteoarthritis Research Society International (OARSI) treatment responder criteria.~      For data analysis results from pressure pain thresholds, temporal summation and conditioned~     pain modulation will create a composite score of pain sensitization. Logistic regression will~     explore the relationship between response to physiotherapy and pain sensitization at baseline~     while accounting for various cofounders.~   "
95973|NCT02310932|"~     This cluster Randomized Controlled Trial was designed to implement and evaluate the effects~     of a multi-level intervention designed to integrate mental health treatment into rural~     primary health clinics in South India using a collaborative care model.~   "
95974|NCT02310919|"~     This is a randomized, double-blind, single center clinical trial study to compare the oocyte~     maturity, embryo development, and risk of ovarian hyperstimulation syndrome (OHSS) after~     receiving the standard dose of human chorionic gonadotropin (hCG) ovulation trigger or a~     lower dose of hCG plus concomitant follicle stimulating hormone (FSH) co-trigger in women~     undergoing in vitro fertilization (IVF).~   "
95975|NCT02310906|"~     This is a first-in-human, multiple-dose 2-part study to assess the safety, tolerability,~     efficacy, and pharmacokinetics of SRP-4053 in Duchenne muscular dystrophy (DMD) patients with~     deletions amenable to exon 53 skipping.~   "
95976|NCT02310893|"~     Consistent treatment with anti-retroviral therapy (ART) suppresses viral load (VL),~     prolonging life and improving quality of life for HIV+ persons. Suppressing VL benefits~     communities by reducing transmission to others. Mere availability of ART and care, however,~     is insufficient; the benefits of ART depend upon HIV+ persons' continuous visits to the~     health care provider, regular monitoring and regular delivery of medications, - known as~     retention in HIV care. In spite of national efforts, up to a quarter of HIV+ persons,~     especially low-income minorities are out of care. Innovative interventions are therefore~     urgently needed to maximize engagement and retention in HIV care, self-reported adherence, as~     well as HIV-1 RNA viral load suppression. In pursuit of these aims, the proposed study will~     assess outcomes of the following interventions in comparison to usual care: 1) contingency~     management (CM) only; 2) peer navigation (PN) only; and 3) a combined approach that~     integrates both CM and PN (CA) which the investigators hypothesize to be most effective in~     improving HIV clinical outcomes.~   "
95977|NCT02310880|"~     Low vision patients have difficulty acquiring sufficient visual information in a timely~     manner for the purpose of performing challenging daily tasks, such as traveling independently~     and safely through busy streets. The advance of virtual reality techniques has provided a~     potential platform for training low vision patients to use their remaining vision more~     efficiently, but the key issue is always whether the patient's visual experiences in a~     virtual world can be transferred to the real world. The proposed study is designed to provide~     definite answer to this question.~   "
95978|NCT02310867|"~     The purpose of this study is to determine the safety and efficacy of hand transplantation as~     a treatment for patients with loss of limb below the elbow, The study will focus on patients~     who have had loss of limb. The primary endpoint is the ability to use the tranplanted limb in~     activities of daily living at 18 months following transplantation measured by a quantitative~     functional test.~      Study activities include several study visits over 18 months and include; demographics,~     medical history, vital signs, psychosocial evaluation, urine, blood test, chest x-ray, bone~     density scans, and biopsies. Subjects who are 18-65 and willing to travel to site and have~     loss of limb will be included in study evaluation.~      Risks of the study include risk of rejection and infection after being transplanted.~     Additional risk are associated with procedures that include blood draws, biopsies, x-rays,~     and potential loss of confidentiality. All patient data will be kept electronically and in~     accordance with the requirements of Duke University. In addition to the experimental data,~     this database includes recipient and donor demographics and transplant relevant medical~     history, range of motion, sensation, and immunosuppressive medications. Data will be recorded~     and reported in accordance with the standards required by the United Network for Organ~     Sharing (UNOS).~   "
95979|NCT02310854|"~     To investigate the hypothesis that suture repair of a ruptured vkb, combined with a dynamic~     intraligamentary stabilization and microfracture of the femoral notch, results in at least~     equal effectiveness compared with an ACL reconstruction using autologous hamstring in terms~     of functional recovery one year postoperatively in terms of a patient self-reported outcome~     related to be able to conduct daily and sporting activities. Secondary, the evaluation of~     clinical outcomes, self-reported by the patient outcomes, osteoarthritis, rehabilitation time~     required for return to daily and sporting activities and levels of sporting activity which~     has returned in patients with status after an ACL rupture and suture repair augmented with a~     dynamic intraligamentary microfracture and stabilization of the femoral notch in comparison~     with an anterior cruciate ligament reconstruction with the ipsilateral hamstring graft.~   "
95980|NCT02310841|"~     This pilot study investigates the feasibility of novel control strategies for actuated~     transfemoral prostheses. Several parameters from gait analysis (including motion-capture and~     ground reaction force measurements) are analyzed. The subjective perception of prosthetic~     functionality is captured with a questionnaire.~   "
95981|NCT02310828|"~     The purpose of this study is to validate the novel hypothesis that daily use of L-cysteine~     (Acetium® capsules) is an effective means to decrease the frequency of (or completely abort)~     the attacks of cluster headache.~   "
95982|NCT02310815|"~     This is a prospective multicenter observational post-approval registry study that will~     collect post-approval data relative to the incidence of pre-specified Adverse Ocular Events~     for cataract surgery patients treated with the FDA-approved ReSure Sealant when used by a~     broad group of physicians under commercial use conditions.~   "
95986|NCT02310763|"~     This is a Phase 2 randomized, 2-period, double-blind, placebo-controlled, multiple ascending~     dose study to evaluate the safety, efficacy, PK and PD of PF-06252616 administered to~     ambulatory boys diagnosed with Duchenne Muscular Dystrophy. Three intravenous (IV) dose~     levels will be investigated in a within subject dose escalating fashion. Subjects will be~     randomly assigned to 1 of 3 sequence groups for approximately 96 weeks (2 periods of 48 weeks~     each). In period 1, two of the sequence groups will receive PF-06252616 and one sequence~     group will receive placebo. In period 2, the placebo group will switch to PF-06252616 and the~     two remaining sequence groups will either receive placebo or PF-06252616. Efficacy will be~     based on an observed mean change from baseline on function (4 stair climb) of PF-06252616 as~     compared to the placebo at the end of period 1. Period 2 provides an opportunity to evaluate~     PK. Subjects will receive monthly IV infused doses of either PF-06252616 or placebo and will~     undergo safety evaluations (Laboratory, cardiac monitoring, physical exams, x-ray, MRI),~     functional evaluations (pulmonary function testing, 4 stair climb, range of motion, strength~     testing, Northstar Ambulatory Assessment, upper limb functional testing and the six minute~     walk test), pharmacokinetic testing and pharmacodynamic testing to evaluate changes in muscle~     volume (MRI).~   "
95987|NCT02310750|"~     The main purpose of the study is to determine if PF-06700841 is safe and well tolerated when~     administered to humans. A secondary purpose is to assess what the body does to PF-06700841~     and to assess what PF-06700841 does to the body when given as single and multiple doses. The~     pharmacokinetic properties of different forms of PF-06700841 may be studied (tablet and~     solution/suspension forms).~   "
95988|NCT02310737|"~     The purpose of this study is to compare sharp and blunt fascial entry during caesarean~     section.~   "
95989|NCT02310724|"~     The primary objective of T2P2 is to track the progression of T2D and related comorbidities~     and complications in the TODAY cohort as they transition to young adulthood. We hypothesize~     that:~        -  Youth-onset type 2 diabetes (T2D) will progress rapidly and result in high rates of~          diabetes-related medical complications and comorbidities.~        -  The rapid rate of progression is related to increased insulin resistance characteristic~          of puberty, worse β-cell function, degree of glycemic control, control of non-glycemic~          factors, and obesity itself.~   "
95990|NCT02310711|"~     The proposed study is a single-center, prospective, pilot, observation study to tabulate and~     measure the changes that occur during treatment and healing for breast conserving therapy~     (BCT) in women with non-metastatic breast cancer for comparison to the multiscale model of~     breast lumpectomy and healing in order to identify targets for improving BCT. The study will~     be comprised of 12 de novo breast cancer patients with non-metastatic breast cancer~     undergoing BCT. Subjects will be enrolled in the study during the 3 weeks prior to receiving~     their BCT surgery and will be followed for six months after the BCT surgery. A total of 6~     visits (not including the surgery) are planned.~   "
95991|NCT02310698|"~     Breast tumors are often detected on mammography but may be harder to see in women with dense~     breasts. This is why screening breast ultrasound is sometimes used as another test in women~     with dense breasts. Ultrasound has been shown to detect additional cancers that are not seen~     on regular mammography.~      Contrast Enhanced Digital Mammography (CEDM) is a FDA approved form of mammography. It is~     essentially a routine digital mammogram performed after iodine dye (the same that is used~     with CT scans) is injected into a vein in the arm. Like screening ultrasound, CEDM has been~     shown to detect breast cancers that are not seen on a regular mammogram. The purpose of this~     study is to compare whether CEDM or screening breast ultrasound is better at detecting~     cancer. Both will be done in this study and compared to one another.~   "
95992|NCT02310685|"~     RATIONALE Controlling cardiovascular risk factors has been proven to be effective in~     prevention and management of cardiovascular disease (CVD). Nonetheless, significant treatment~     gaps have been demonstrated repeatedly in numerous surveys. A recent study of Canadian adults~     filling prescriptions for hypertension or dyslipidemia demonstrated that the majority~     remained overweight and sedentary despite being at risk of developing CVD. Medication~     adherence has been shown to be poor with up to 50% of patients stopping therapy after one~     year.~      Patient-centred care can lead to improved clinical management and patient satisfaction.~     Adherence with prescribed therapy can also be improved if individuals understand the~     importance of their risk factors, are aware of their overall health status and participate in~     decision making surrounding pharmacotherapy and lifestyle changes.~      Community pharmacists are frontline healthcare professionals who can identify patients at~     risk of CVD, assess their adherence with recommended lifestyle behaviours or drug therapy and~     engage them in shared decision making surrounding health promotion strategies. Local~     pharmacies could effectively become readily accessible community health centres nationwide.~      Research Objectives. The primary objective is to evaluate, in a randomized clinical trial,~     the impact of a community pharmacy intervention to improve the management of cardiovascular~     risk factors vs a basic e-health education program. The intervention will include a~     cardiovascular or cardiometabolic risk assessment providing the individual with their~     Cardiovascular or Cardiometabolic Age. Individuals at increased risk of CVD and/or with~     modifiable risk factors will also be offered a one year subscription to a multidisciplinary,~     pharmacy based, e-health promotion program to improve management of CVD risk factors such as~     weight loss and increased physical activity and track their progress in managing their risk~     factors and reducing their Cardiovascular or cardiometabolic Age. Changes in CVD risk~     factors, Cardiovascular/cardiometabolic Age, and uptake or adherence to medications and~     lifestyle changes will be examined 3 months, 6 months and one year post intervention.~      Study Hypothesis. Investigators hypothesize that engaging patients in a discussion of their~     Cardiovascular or Cardiometabolic Age and management of their risk factors will result in~     improved healthy lifestyle habits moreover increased physical activity and weight loss.~   "
95993|NCT02310672|"~     The study evaluates the effect of macitentan on right ventricular and hemodynamic properties~     in patients with symptomatic pulmonary arterial hypertension. Patients are treated with~     macitentan for 1 year. Patients undergo right heart catheterization (RHC) at baseline and~     Week 26. They also undergo cardiac magnetic resonance imaging (MRI) at baseline, Week 26 and~     Week 52. Safety is monitored throughout the study. The study has three stub-studies. Each~     patient can participate in no sub-study or in one sub-study. The sub-studies are: (1)~     metabolism sub-study (with PET-MR scans); (2) biopsy sub-study (biopsies taken during the~     RHC); (3) Echo sub-study.~   "
95994|NCT02310659|"~     Coronary artery calcification (CAC) is a pandemic condition in elderly patients with coronary~     artery disease (CAD) and associated with worse prognosis. Although available data shows~     association between testosterone levels in men and CAD, the association between testosterone~     and CAC in old-aged male patients with CAD remains unknown. In this study, the relationship~     of serum testosterone levels with CAC score in elderly male patients with CAD was evaluated.~   "
95995|NCT02310646|"~     To gather insight on how product attributes affect usability by investigating the factors~     that are thought to influence patient preference to topical anti-psoriatic treatments.~   "
96487|NCT02304224|"~     The aim of the study is to investigate the relationship of nocturnal use of eye masks and~     immune function, cerebral function and outcomes of patients with sepsis. Thus more efficient~     and comprehensive treatment could be provided for patients in the duration of admission in~     intensive care unit.~   "
95996|NCT02310633|"~     Blast-related and blunt traumatic brain injury is a key priority area of Rehabilitation~     Research & Development (RR&D) and represents a critically important public health problem~     facing the Veteran population. Developing efficacious treatments for persistent memory~     deficits seen in this population is a key step in reducing the impact that such problems have~     in the everyday lives of Veterans. Memory problems after TBI in Veterans are quite~     heterogeneous, and efficacy will likely be maximized by developing and disseminating multiple~     alternative treatments individually matched to the Veteran's key deficits, and by research~     that seeks to understand the cognitive and neural basis of treatment-related change over~     time. The results of this approach may aid clinical decision making and assignment of~     patients to rehabilitative treatments most likely to improve memory capacity and functional~     outcome.~   "
95997|NCT02310620|"~     The aim of the study is to show that regular playing with the logic games developed in the~     framework of the M3W (Mental Wellness Toolset) project (https://m3w-project.eu/) can prevent~     mild cognitive impairment (MCI) and dementia.~      The secondary aim of the study is to find correlations between the results of the games and~     the standard assessments for dementia and MCI screening such as the Rey Verbal Learning Test.~   "
95998|NCT02310607|"~     This study aims to evaluate a prototype device detecting zinc protoporphyrin-IX fluorescence~     non-invasively from the intact oral mucosa. Zinc protoporphyrin-IX is an established~     indicator of iron deficiency. The prototype device is used to measure the erythrocyte zinc~     protoporphyrin-IX/heme ratio for women after delivery, a study group chosen because of an~     elevated risk of iron deficiency. The results from the non-invasive measurements are compared~     to reference measurements of the erythrocyte zinc protoporphyrin-IX/heme ratio from residual~     blood samples from the same patients and to other indicators of iron status, including~     hemoglobin, ferritin, serum iron, transferrin, transferrin saturation and soluble transferrin~     receptor.~      Funding Source - Nestec Ltd.~   "
95999|NCT02310594|"~     This research trial studies the effect of radiation therapy on tumor immunity. Standard~     radiation therapy destroys tumor cells. In response to tumor cell death caused by radiation~     therapy, the body has an ability to stimulate an anti-tumor response (immunity), but this~     response is often ineffective in shrinking tumor tissue. Collecting samples of blood from~     patients before, during, and after radiation therapy to study in the laboratory may help~     doctors learn more about the effects of radiation therapy on anti-tumor response.~   "
96000|NCT02310581|"~     This is a phase 3, multicenter, randomized, double-blind, multiple-dose, parallel-group,~     placebo-controlled study to evaluate the safety and efficacy of up to 3 dosing regimens of~     Buprenorphine Sublingual (under the tongue) Spray and/or matching placebo in participants~     with moderate to severe postoperative pain after bunionectomy. The study will comprise 4~     periods: the Screening Period, the Surgical Period, the Treatment Period, and the Follow-up~     Period.~      Participants will be admitted to the study site on the morning of the scheduled surgery, will~     remain at the study site until postoperative Day 3 (a total of 3 nights at the study site),~     and will return for the Follow-up Visit 5 to 9 days after surgery.~   "
96001|NCT02310568|"~     This study aims to evaluate whether PF-06372865 is safe and effective in the treatment of~     sub-optimally controlled symptoms of generalized anxiety disorder during two 4-week treatment~     periods using a Sequential Parallel Comparison Design (SPCD). The study will use the Hamilton~     Anxiety Rating Scale (HAM-A) to measure change in symptoms from baseline for two doses of~     PF-06372865 compared to placebo.~   "
96002|NCT02310555|"~     The aim of this study is to compare clinical and laboratory findings of three surgical~     techniques in metabolic surgery in patients with type II diabetes mellitus and obesity (BMI>~     30).~   "
96003|NCT02310542|"~     A critical issue of the clinical syndrome in liver failure is the accumulation of toxins not~     cleared by the failing liver. Based on this hypothesis, albumin dialysis is used to remove~     those substances. Albumin dialysis with recirculation (MARS) is the most used system but~     required specific system and expert environment. Alternative system without recirculation~     (SPAD) is less expensive and can be realised in critical care services trained to extrarenal~     epuration. The primary objective of this study is to compare biological and clinical~     efficacy, pulsatility index of middle cerebral artery modification and tolerance of both~     systems.~      This is a prospective, open, cross-over comparative study of two albumin dialysis system.~     Each patient will receive the two systems in an randomly assessed order. Patients are divided~     up according to bilirubin plasmatic level. (250µmol/L to 400 µmol/L and >400µmol/L).~   "
96004|NCT02310529|"~     Depression related to pregnancy frequently presents postpartum depression, which has~     deteriorating and lasting negative effects, not only on infant and child well being but also~     on mother's and father's mental health (Nancy K et al 2009). It is therefore important to~     introduce interventions aiming to improve mental health of mothers that could minimize the~     risk of diseases, and have positive effect child's on physical and psychological~     developmental wellbeing.~      Therefore, this project has been designed to assess the effectiveness of Interpersonal~     Psychotherapy for Postnatal Depression in Pakistan.~   "
96014|NCT02310399|"~     This study is a feasibility study of the Nucleus 24 ABI in children without NF2. It will be~     conducted as a repeated-measures, single subject experiment in order to accommodate the known~     variability in cochlear implant clinical results. Data obtained in the course of this study~     will be compared with the existing published outcome data from children with normal hearing~     and with cochlear implants (CIs). These comparisons may provide additional useful information~     about the progress of ABI subjects' performance over time. Also, this may allow the results~     of the current study to be utilized to design future pivotal studies of the device in the~     pediatric population.~   "
96015|NCT02310386|"~     Fibromyalgia is one the most common causes of chronic pain syndromes in women. It causes~     considerable costs in primary health care setting as well as specialized medical care~     sector.Electrotherapy and exercise therapy has shown to have short-term pain relieving~     effects in randomized controlled trials (RCT) among fibromyalgia patients. However, there is~     sparse knowledge about the effects of long-term RCTs in the treatment of pain in~     fibromyalgia, as there are no publications about cost-effectiveness analysis of such~     treatments.~      The aim of this study is to investigate whether the BEMER electromagnetic field therapy~     device has beneficial long-term effects in the treatment of pain, and whether it improves~     fibromyalgia patients' quality of life. In addition, this study investigates whether the~     BEMER device treatment is cost-effective in the treatment of fibromyalgia patients.~   "
96005|NCT02310516|"~     The brain awake surgery has recently boomed in neurosurgical oncology but also in epilepsy~     surgery. The goal of awake surgery is to allow a more precise localization of sensorimotor~     functions, languages and cognitive to better respect them. Indeed, the interindividual~     anatomo-functional variations, the lack of specificity of functional explorations~     radiological magnetic or nuclear, as well as the reorganization of the areas involved in~     these functions (mechanisms of brain plasticity) in epileptic patients or patients with~     cerebral tumor do not allow to identify them in preoperatively. Brain awake surgery allows an~     analysis and a precise real-time identification of areas and networks involved in these~     functions through a direct electrical stimulation (inhibitory or activatory). Thus, this~     surgical technique has become a gold standard in surgery of brain lesions located in~     functional areas.~      However, although the brain awake surgery has been practiced since many years, the~     confidentiality of these informations until recent years explains probably that very little~     data to be available on the personal experience of this procedure by patients. Studies that~     have analyzed the perception of the patient or the satisfaction of the patient after surgery~     in awake conditions were retrospective and included few patients. The investigators~     experience of lived of this surgery that the investigators have developed in the~     investigators team since over four years is that on the whole awake surgery is well tolerated~     if adequate explanations are provided preoperatively and if a minimum of preoperative~     precautions are observed.~      Thus, the investigators have decided to develop a preoperative device that could improve~     personal experience and well-being of patients undergoing this surgical approach.~   "
96006|NCT02310503|"~     REGESMOHS (Registro Español de cirugía de Mohs) aims at describing effectiveness of Mohs~     surgery, and patient, tumor and technique factors related to adverse events and tumor~     recurrence.~      REGESMOHS is a prospective cohort, including all patients considered for Mohs surgery in~     participating centers. All consecutive patients are included. The only exclusion criteria are~     being under 18-years-old or legally incompetent. Pre-planned follow-up is as required by~     common clinical practice, but at least once a year for the study period.~   "
96007|NCT02310490|"~     Study DA-13-007 is a randomized, evaluator-blinded, within subject (split face) multicenter~     clinical study of DermaVeil (Injectable poly-l-lactic acid) compared to SCULPTRA in the~     treatment of nasolabial fold wrinkles. Qualifying subjects will be randomized to receive~     DermaVeil and SCULPTRA on either the right or left side of the face.~   "
96008|NCT02310477|"~     This is a largest cohort study aimed to estimate the overall survival of patients been~     treated with regorafenib for metastatic colorectal cancer (mCRC) within the frame of a french~     compassionate program.~   "
96009|NCT02310464|"~     The purpose of this clinical study is to assess the safety and tolerability and efficacy of~     active immunotherapy with dose escalation and cohort expansion of OBI-833 in~     advanced/metastatic gastric, lung, colorectal, or breast cancer subjects.~   "
96010|NCT02310451|"~     Recent progresses have been made in the treatment of metastatic melanoma, nevertheless~     improved patient survival is still limited because of primary resistance and relapses. It is~     therefore important to continue to understand the molecular mechanisms involved in melanoma~     development and progression to improve the management of patients.~      Drugs such as the alkylating agents (temozolomide and fotemustine) or vemurafenib trigger~     senescence-like phenotypes in melanoma cells. It is now known that senescent cells secrete~     some factors that exert a pro-tumoral role but the potential existence and the role of~     insoluble factors remain undetermined.~      Preliminary results from the investigators laboratory indicate the presence in the senescent~     secretome of exosomes; microvesicles involved in intercellular communication,~     immunomodulatory functions, and tumorigenesis. Several studies showed that these vesicles~     shape the tumor microenvironment and contribute to the migration of cancer cells.~      Their interest in oncology as a prognostic factor and marker of therapeutic response is~     increasing.~      Thus, our project aims to study the effect of exosomes produced by senescent melanoma cells~     in the development and progression of melanoma in vitro and in vivo using cell cultures and~     animal models.~      In addition, the investigator propose a pilot study whose objective is to determine the~     effect of vemurafenib on nanovesicles produced by patients with advanced unresectable or~     metastatic melanoma.~      The investigator hope to show that exosomes participate in the process of drug resistance and~     relapse, with the goal of developing (with the exosomes study) theranostic tools for~     personalized care in patients.~   "
96011|NCT02310438|"~     Impairment of arm function is more common than lower limb impairment in stroke patients and~     is also more resistant to treatment. Several clinical trials with stroke patients have~     produced statistically significant gains in upper limb function when using instrumental~     playing and treatments where rhythm supports the priming and timing of movements. Based on~     the positive results from controlled and non-controlled trials, the Cochrane review of music~     therapy for acquired brain injury (Bradt, et al., 2010) recommends further investigation into~     rhythm based techniques to treat hemiparesis in stroke patients, and that future studies need~     to examine the relationship between the frequency and duration of interventions and treatment~     effects.~      The aim of this study is to examine whether or not a thirty minute, twice weekly, six week,~     home music therapy treatment, playing set musical patterns on instruments to music is~     feasible to deliver, and will lead to improved coordination, dexterity and activities of~     daily living in hemiparetic stroke patients.~      Twelve patients will be recruited from Cambridgeshire Community Services NHS trust (CCS) who~     are between one month and two years post stroke with hemiparesis. Participants will have~     completed and been discharged from community rehabilitation for their upper limb and not be~     receiving any other treatment for arm function. They will be randomised into two groups:~     treatment (for immediate treatment following discharge from community rehab) and waiting list~     (beginning 9 weeks after baseline measure). Participants will be assessed at the beginning~     and end of treatment (just before starting and just after completing 6 weeks of treatment) by~     one of two experienced community occupational therapists under contract with CCS, who are~     also experienced in working with stroke patients and who will be blind to the experiment. The~     other three measures will be conducted by the chief investigator. The assessment tools will~     be the Action Research Arm Test (ARAT) and nine hole peg test (9HPT). There will also be a~     pre and post treatment semi-structured interview for each participant, which will be~     conducted by the chief investigator. ARAT and 9HPT assessments will be administered to all~     participants at the same time points: baseline and then at week 6, 9, 15 and 18. Data will be~     analysed to determine if the treatment is effective compared to no treatment (wait list)~     following community discharge, and whether earlier intervention (treatment group) yields~     better results for participants, all of whom will eventually receive treatment.~   "
96012|NCT02310425|"~     Immature gastrointestinal functions increase the risk of poor growth as well as nosocomial~     infections and necrotizing enterocolitis (NEC) in the preterm infant. The effects of~     probiotics on growth and development in premature infants have been investigated poorly.~     Saccharomyces boulardii CNCM I-745 (S. boulardii) is a non-pathogenic probiotic yeast.~      Prophylactic supplementation of S. boulardii at a dose of 50 mg/kg twice a day appeared to~     bring preterm infants weight gain closer to that of intra-uterine growth rate, reduce feeding~     intolerance, and had no adverse effects.~   "
96016|NCT02310373|"~     This is a pilot study on the acute effects of nicotine-free hookah (herbal/steam stones)~     smoking on the sympathetic neural control of the human cardiovascular system. Hookah smoking~     is known to transiently increase blood pressure and heart rate while decreasing heart rate~     variability suggesting - but not proving - sympathetic mediation. The contribution of~     nicotine to these effects is unknown. Here the investigators will directly measure the acute~     effects of nicotine-free Hookah smoking on sympathetic nerve activity with microneurography~     (intraneural microelectrodes) and quantify associated regional changes in vasomotor tone.~   "
96017|NCT02310360|"~     The purpose of this study is to investigate whether a combination of taste probes and~     food-related cues can induce dopamine release in striatal and extra-striatal brain regions in~     healthy subjects.~   "
96018|NCT02310347|"~     The purpose of this study is to examine the influence of a medicinal cannabinoid agonist~     versus placebo on behavioural and gut peptide responses to food images and food intake.~   "
96019|NCT02310334|"~     The objectives of this study are to demonstrate that real time physiological status~     monitoring and the use of optimization techniques during exercise can have a positive impact~     on physiological status, and to collect metabolic flexibility profiles of young fit adults~     during rest and exercise.~   "
96020|NCT02310321|"~     The purpose of this study is to determine the maximum tolerated dose (MTD) and/or recommended~     expansion dose (RED) of ASP2215 concomitant with cytarabine/idarubicin as induction~     chemotherapy based on the status of the onset of dose-limiting toxicity (DLT) in newly~     Diagnosed Acute Myeloid Leukemia (AML). Safety and tolerability of ASP2215 will also be~     evaluated. This study will also characterize the pharmacokinetic (PK) parameters of ASP2215~     concomitant with induction and consolidation chemotherapy as well as evaluate the PK~     parameters of cytarabine concomitant with ASP2215.~   "
96021|NCT02310308|"~     The effect of chewing gums containing MBE and xylitol on different variables related to~     caries and gingivitis in a sample of adult volunteers with a high risk for caries will be~     evaluated. The main result of that double-blind randomized controlled interventional trial~     will be that chewing gum containing MBE was more effective in reducing plaque acidogenicity,~     salivary mutans streptococci concentration and gingival bleeding compared to a xylitol and~     sugar-free chewing gum.~   "
96022|NCT02310295|"~     Purpose: To compare the effects of macular photocoagulation with or without intravitreal~     bevacizumab (IVB) or triamcinolone (IVTA) for the treatment of diabetic macular edema (DME).~     Casuistic and Methods: 58 eyes of 44 patients with diffuse DME were randomized to receive~     either IVB + focal/grid laser (IVB-Laser, n=19), IVTA + focal/grid laser (IVTA-Laser, n=16)~     or focal/grid laser alone (Laser, n=23). Ophthalmic evaluation, including best-corrected~     visual acuity (BCVA), intraocular pressure (IOP) and central macular thickness (CMT) were~     performed at baseline and monthly for 12 months.~   "
96023|NCT02310282|"~     Observational prospective single-center study on the discriminatory value of the Unassisted~     TeleStroke Scale for differentiation between patients with lacunar stroke and those with~     other acute stroke syndromes.~   "
96024|NCT02310269|"~     This is a non-interventional, multinational, multi-center post-marketing study, to further~     document the safety and efficacy of pasireotide s.c. administered in routine clinical~     practice in patients with Cushing's disease. Patients with Cushing's disease and treated with~     pasireotide s.c. alone and in combination with other therapies will be monitored. For this~     study, each enrolled patient will be followed up for 3 years after enrollment. Patients who~     permanently discontinue pasireotide s.c. prior to completing the 3-year observation period~     will be followed up for 3 months after the last dose of pasireotide s.c.~   "
96025|NCT02310256|"~     The aim of the study is to evaluate whether walking capacity in patients with intermittent~     claudication is improved more by home-based 5+ exercise training than by current~     recommendations of daily walking. The study will elucidate if such a potential effect is~     dependent on changes in mitochondrial respiratory capacity, blood flow or both.~   "
96026|NCT02310243|"~     Diagnosis: Acute myeloid leukemia; Acute lymphoblastic leukemia Age ≥ 18 years, no upper age~     limit Study drug: Palbociclib Phase Ib/IIa, open-label~        -  Phase Ib: Based on previous experience with 125 mg palbociclib once daily for 21 days~          followed by 7 days of rest in patients with breast cancer, liposarcoma, non-small cell~          lung cancer, hepatocellular carcinoma, ovarian cancer, mantle-cell lymphoma, and~          glioblastoma, this regimen will be chosen for the first dose to be evaluated in the~          phase Ib. Based on a 3 + 3 modified Fibonacci design, the tolerable dose of palbociclib~          for the phase IIa is defined.~        -  Phase IIa: single-agent palbociclib using the tolerable dose defined in the phase Ib~          part of the study is administered once daily for 21 days followed by 7 days of rest.~          Based on the optimal two-stage design of Simon, 21 patients are treated in the first~          stage. If results are positive, 29 additional patients will be recruited into the second~          stage of the study. An efficacy of the investigational therapy will be rejected in the~          first stage of 21 treated patients if two or less patients achieve complete remission~          (CR), CR with incomplete blood count recovery (CRi), partial remission (PR), or~          anti-leukemic effect (ALE). If three or more patients achieve CR, CRi, PR, or ALE during~          this first stage, the trial is intended to be continued in the second stage with a total~          sample size of 50 patients.~      Start of recruitment: July 2015 End of recruitment: July 2017 End of study (last patient~     out): July 2018 The treatment duration of an individual patient is estimated to be 2-6~     months, but may be unlimited in patients with sustained response (case-by-case decision).~      Observation time per patient after entry into the study (incl. treatment) is at least 12~     months.~   "
96027|NCT02310230|"~     Purpose: To assess the utility of a new medical device that monitors a patient's breathing~     during medical procedures in which a patient is sedated, but not mechanically ventilated. In~     minor procedures, such as endoscopy (where the doctor examines a patient's digestive tract by~     a TV camera inserted through the mouth), patients do not require general anesthesia, in which~     a machine would take over their breathing while they are unconscious for surgery. However,~     during endoscopic procedures it is sometimes difficult for the anesthesiologist to monitor~     the patient's breathing—specifically, to monitor changes in breathing patterns and the~     adequacy of breathing. In endoscopy procedures, the room is darkened, and the patient's mouth~     is generally occupied by the endoscope. While the anesthesiologist can listen to the~     patient's breathing sounds with a stethoscope, this type of monitoring can only be done~     periodically, and there is limited ability to gauge the adequacy of ventilation. This study~     will use the ExSpiron Respiratory Volume Monitor (RVM), which measures non-invasive minute~     ventilation (MV), tidal volume (TV) and respiratory rate (RR), in patients undergoing an~     endoscopic procedure to provide additional information regarding the effects of clinical~     interventions such as drug administrations or airway maneuvers on the patient's respiratory~     status.~      For patients who give informed consent, study participation means that they will have a~     PadSet consisting of 3 electrodes applied to the chest. Another component, a nasal cannula (a~     thin clear plastic tube that goes under the nose) will give patients supplemental oxygen, and~     is standard of care for endoscopy at UVM Medical Center. Patients will then be asked to~     breathe in and out of a portable spirometer (breath meter) for 30 seconds up to five times.~     This data will be compared to data recorded by the monitor to confirm that the monitor is~     recording accurately. The procedure will then go forward in the normal fashion. Patients will~     be randomly placed into one of two groups. In the first group during the procedure, the~     anesthesiologist will not be able to see the numbers (MV, TV, and RR) displayed screen of the~     monitor, so the data will not be used to guide the patient's clinical care. In the second~     group, the anesthesiologist will be able to see the RVM measurements of MV, TV, and RR to~     evaluate the effect of the interventions. Monitoring for both groups will continue in the~     recovery room, until discharge.~   "
96028|NCT02310217|"~     The relationship among hypertension, aging and cognitive decline is complex and not~     completely understood. Purpose of this project will be evaluating early markers of cognitive~     deterioration in patients with arterial hypertension. In particular, this cross-sectional~     observational study will be articulated in three phases:~        1. Neuropsychological evaluation of general cognitive abilities~        2. Identification and measurement of specific biomarker levels~        3. Correlation among hypertension, cognitive abilities and biomarkers.~   "
96029|NCT02310204|"~     The primary objective of this research protocol is to assess the effect of a structured~     therapeutic education program on the quality of life of patients with moderate to severe~     psoriasis~   "
96030|NCT02310191|"~     New brain ischemic lesions are detected in about 50% of patients undergoing carotid artery~     stenting (CAS). The aim was to assess correlation between selected laboratory markers and~     occurrence of new brain infarctions after CAS.~   "
96031|NCT02310178|"~     The aim of this cohort is to evaluate the follow-up of morbidly obese patients treated by~     several types of bariatric procedures. In addition, this study could lead to the development~     of clinical trials on assessment of the bariatric surgery impact.~   "
96032|NCT02310165|"~     The purpose of this study is to compare two different methods that are used for inserting the~     needle during paracentesis. One method is called the coaxial insertion technique and the~     other is called the z-tract technique. Researchers would like to see which method is better~     and leads to less problems like oozing from the needle insertion site and pain during the~     procedure. Both methods are approved and currently used methods for doing a paracentesis at~     the University of Virginia. Which method is used generally depends on physician preference.~     There have been no studies done to date that compare these two methods for needle insertion.~   "
96033|NCT02310152|"~     Childhood anxiety disorders are very common, carry tremendous personal and societal costs,~     frequently do not respond adequately to treatment, and involving parents in treatment has so~     far not enhanced outcomes. Explanatory clinical trials are needed to identify parent specific~     mechanisms of change that are not targeted in direct child treatment, and to identify markers~     of who is most likely to benefit from parent intervention. This study is an explanatory~     clinical trial of a parent based intervention and of cognitive behavioral therapy, and an~     investigation of biological and behavioral moderators of treatment response.~   "
96034|NCT02310139|"~     Colonoscopy is a commonly used investigation to diagnose and treat various gastrointestinal~     disorders. In addition, colonoscopy provides the opportunity to remove colonic adenomas this~     removal is also known as polypectomy.~      Polypectomy has proven to reduce occurrence of colorectal cancer and likelihood of dying from~     it. Colonoscopy can be challenging due to technical or patient factors. In a small proportion~     of patients a complete colonoscopy is unsuccessful. Such patients either get referred to a~     tertiary centre with extensive experience in difficult colonoscopy or have an alternative~     test such as CT scan. The investigators unit has accumulated significant experience related~     to previously failed colonoscopy and anecdotally appears to have a high success rate in~     completing the procedure.~      The purpose of this project is to describe the investigators technical approach to management~     of patients with previously failed colonoscopy. There is no additional intervention and the~     project is observational in nature. The investigators will collect data on patient~     characteristics, the reason for the failure and what technique was used to overcome the~     difficulty. The investigators will also note whether the final outcome of the technique had~     any impact on the overall management of the patient.~   "
96035|NCT02310126|"~     Subjects will evaluate each study lens in a random order. The lenses will be worn in both~     eyes for a short period.~   "
96036|NCT02310113|"~     The aim of the present study was to re-challenge the current data that anaemia in chronically~     anaemic haematology patients is not associated with low skeletal muscle StO2, and that the~     age of RBCs does not influence tissue responses. The investigators investigated these aspects~     using improved technology NIRS devices, for deeper tissue penetration and removal of the~     superficial signal from the skin.~   "
96037|NCT02310100|"~     A prospective, multicenter, interventional study to collect confirmatory evidence on the~     safety and effectiveness of the TactiCath® percutaneous ablation catheter in the post~     approval setting for the treatment of symptomatic paroxysmal atrial fibrillation using~     contact force assisted irrigated radiofrequency ablation.~   "
96038|NCT02310087|"~     The purpose of the study is to determine whether administration of dietary supplement of~     astaxanthin with vitamin E improves the quality of sperm, fertilization and embryo~     development in Assisted Reproduction Techniques (ART) procedures.~   "
96039|NCT02310074|"~     Idiopathic hypogonadotropic hypogonadism (IHH) is the most common disorders of sex~     development (DSD).Therapy for IHH includes hormone replacement therapy, gonadotropin therapy~     and pulsed infusion of gonadotropin releasing hormone (GnRH).In the present study, we~     compared the different efficacy and safety of pulsatile GnRH pump therapy with combination~     gonadotropin therapy on fertility and sexual development in male patients with IHH.~   "
96040|NCT02310061|"~     Volume overload is a leading risk factor for death and cardiovascular events in end stage~     renal disease patients maintained on chronic dialysis, particularly in those with myocardial~     ischemia and heart failure which represent a substantial fraction of this population. Early~     identification of volume overload may prevent cardiovascular sequel in these patients but~     clinical signs of volume expansion are unsatisfactory to reliably identify patients at risk~     and to monitor them over time. On the other hand, however reliable, standard techniques for~     measuring extracellular or circulating (blood) volume do not convey information on~     fundamental heart function parameters that determine the individual haemodynamic tolerance to~     volume excess and the response to ultrafiltration, i.e. left ventricular (LV) filling~     pressure and LV function.~      Extra-vascular lung water is critically dependent on these parameters and represents a proxy~     of both, circulating volume and LV filling pressure and function, and may therefore be a~     better criterion to identify patients at a higher risk of volume-dependent adverse clinical~     outcomes and to monitor the effect of therapy aimed at preventing these outcomes. A fast (< 5~     min.), easy to learn, simple and non-expensive technique which measures extra-vascular lung~     water by using standard ultrasound (US) machines has been validated in dialysis patients.~     Whether systematic measurement of lung water by this technique may translate into better~     clinical outcomes in End Stage Renal Disease (ESRD) patients has never been tested.~      The aim of this randomized clinical trial is that of testing a treatment policy guided by~     extra-vascular lung water measurements by ultrasound to prevent death, decompensated heart~     failure and myocardial infarction as well as progression of Left Ventricular Hypertrophy~     (LVH) and LV dysfunction and hospitalization in high risk dialysis patients with myocardial~     ischemia (a history of myocardial infarction with or without ST elevation or unstable angina,~     acute coronary syndrome documented by ECG recordings and cardiac troponins or stable angina~     pectoris with documented coronary artery disease by prior coronary angiography or ECG) or~     overt heart failure (NYHA class III-IV).~   "
96041|NCT02310048|"~     The purpose of this study is to assess the comparative oral bioavailability of a Formulation~     B versus the Formulation A of MT-1303.~   "
96044|NCT02310009|"~     Subjects (N=48) with poorly-controlled type 2 diabetes (HbA1c>7%) will be assigned to one of~     the 4 following interventions in a randomised, parallel group design: [I] Control (placebo~     injection; no exercise), [II] Anakinra (100 mg subcutaneous injection of human recombinant~     interleukin-1 receptor antagonist), [III] Exercise (1 h cycle ergometry at 75% VO2max), [IV]~     Anakinra + Exercise. Pancreatic beta-cell function (plasma insulin responses) will be~     measured before and after each intervention using a hyperglycemic clamp (5.4 mM above basal~     glucose) combined with GLP-1 infusion (0.5 pmol/kg/min) and arginine injection (5 g bolus).~   "
96045|NCT02309996|"~     Supervisors of injured workers play a key role in preventing prolonged work absences.~     Providing supervisors with tools to improve their response to musculoskeletal and other~     workplace injuries or illnesses may improve worker health and disability outcomes.~      The primary objective of this research study is to determine the effectiveness of the~     supervisor training program, the SMART Supervisor Training Program, on reducing the total~     duration of workers' lost-time claims. The secondary objectives are 1) to determine the~     effectiveness of the training program on reducing the cumulative incidence of workers'~     lost-time injuries and sick leave days; 2) to determine if implementation of the training~     program is associated with improvements in hypothesized mediating variables, such as~     attitudes toward job accommodations, response to workplace injury, and communication with~     employees and healthcare providers; 3) to investigate the implementation of the training~     program by conducting a process evaluation.~      The investigators hypothesize that:~        1. the duration of lost-time claims for workers working under supervisors receiving the~          training program will be shorter than the duration of lost-time claims for workers with~          supervisors in the control group;~        2. the cumulative incidence of lost-time injuries and sick leave days will be lower in the~          group receiving the training program compared to the control group;~        3. the training program will be associated with increased knowledge, response,~          communication and changed attitudes towards workplace accommodation.~      This research is of significance to North American employers and compensation systems because~     there is a lack of knowledge about the usefulness of supervisor training to prevent or reduce~     work disability. It also has important implications for guiding employer policies and~     practices, and for identifying circumstances where supervisor training should be a priority.~   "
96046|NCT02309983|"~     For many after spinal cord injury (SCI) there is immobilization, muscle atrophy, bone loss,~     fracture risk during transferring (or falls), and the risk of secondary complications, and~     increase in attendance care and cost. It is important to develop multi dimensional~     rehabilitation strategies for people after SCI to enhance functional recovery towards~     walking, and enhance an increase in muscle and bone to potentially prepare the injured~     nervous system in the event of a cure. Locomotor training (Stand retraining and step re~     training) an activity-based rehabilitative approach generates muscle activity and provides~     weight bearing and joint contact kinetics, even in individuals who are unable to stand or~     step independently. Cross-sectional animal and human SCI studies have demonstrated that~     locomotor training (LT) (stand retraining and step retraining using body weight support~     treadmill training) has improved the capacity to stand independently and walk at faster~     speeds. Neuromuscular stimulation (NMS) or electrical stimulation (ES) training is a~     rehabilitative approach that generates muscle activity, alternating leg extension and flexion~     even in individuals who are unable to stand or step independently. NMS studies for~     individuals after SCI have shown improvements in bone density and muscle strength after~     cycling and resistance training. The main purpose of this study is to address whether stand~     retraining and NMS compared to stand retraining alone or NMS alone will increase neural and~     musculoskeletal gains and provide a greater functional recovery towards independent standing.~      This project will be completed at two sites: Kessler Foundation Research Center (the grant PI~     site) and Frazier Rehabilitation Institute, University of Louisville, Kentucky.~   "
96047|NCT02309970|"~     CT perfusion (CTP) of the brain is an innovative technique to identify rapidly regions which~     are only partially or insufficiently perfused during an acute ischemic event. The~     differentiation between the core infarct and the still viable penumbra is its major clinical~     application. CTP helps directly in the decision-making process in the event of acute ischemic~     stroke by increasing the potential of success in patient who can benefit from~     thrombolytic/endovascular treatment.~      The use of CTP in patient selection for thrombolytic/endovascular treatment was never~     evaluated in a prospective randomized study. Yet, clinical experience well demonstrated a~     good correlation between the size of the penumbra and the clinical outcome when done in early~     as well as late stages of the event.~      The importance of identifying the penumbra in the acute phase of the ischemic stroke is~     widely accepted. But crucial evidence to support the predictive value of CTP to predict the~     clinical and anatomical/structural outcomes in the late phases (90 days after) is lacking.~      Currently, the use of CTP is based on theoretical assumptions and expert opinions but a~     randomized prospective study to validate its use is lacking.~      The current guidelines restrict the use of CTP trials and to patients that can't performed~     MRI scan.~   "
96048|NCT02309957|"~     Prospective, multi-center, non-randomized, historical controlled, post-market study of~     patients requiring surgical repair of a focal articular cartilage lesion or osteochondral~     defect in the knee.~   "
96049|NCT02309944|"~     The purpose of the study is to test whether the use of a new wound closure technique can~     decrease the rates of wound complications in obese cancer patients.~   "
96050|NCT02309931|"~     The study will provide a precise control compared to the two interventions (iso vs~     antiperistaltic anastomoses) with thorough measurements of the postoperative variables and~     complications to improve the evaluation of the surgical technique. It will also enable an~     evaluation of the quality of life after the procedures.~   "
96051|NCT02309918|"~     This is an open-label, single arm, multicenter, pilot-study to compare the efficacy and~     safety of LDV/SOF fixed dose combination (FDC) in subjects with acute genotype 1 HCV~     infection. A total of 20 subjects will be assigned to receive LDV/SOF FDC tablet (LDV 90~     mg/SOF 400 mg/) once daily for 6 weeks.Patients will be followed up for 24 weeks.~   "
96052|NCT02309905|"~     The purpose of this study is to determine whether Tele-expertise would be effective and~     cost-effective by reducing the number of secure transportations for inmates in need of a~     dermatological consultation~   "
96053|NCT02309892|"~     The primary purpose of this research study is to evaluate how safe, how well tolerated and~     how effective a range of doses of L-DOS47 in combination with standard doublet therapy of~     pemetrexed/carboplatin in patients with Stage IV (TNM M1a and M1b) recurrent or metastatic~     non-squamous Non-Small Cell Lung Cancer.~   "
96054|NCT02309879|"~     This study aims to compare the quality of perioperative analgesia of lidocaine, magnesium~     sulphate and remifentanil in patients undergoing mastectomy~   "
96068|NCT02309697|"~     This study will utilize two validated tools for assessing child development and behavior, to~     investigate the outcomes for children born preterm compared with those born at full term. Two~     hundred children born or cared for during the neonatal period at Mount Sinai Hospital will be~     enrolled. Parents will be asked to complete a behavioral assessment questionnaire, and which~     will assess development in an examination administered by a trained occupational therapist at~     Mount Sinai Hospital.~   "
96055|NCT02309866|"~     Retinitis Pigmentosa (RP) is the most common form of hereditary retinal degeneration, with a~     worldwide prevalence of 1:3500. It is one of the most genetically heterogenous conditions in~     humans, with over 100 causative genes and loci reported to date. However, in approximately~     40% of patients the underlying genetic causes are yet to be found.~      The current study aims to identify causative RP genes and mutations in Israeli families of~     various ethnic backgrounds. Identification of such genes will contribute significantly to~     disease prevention (by identification of high risk families and appropriate genetic~     counseling) and to the investigators understanding of retinal structure and function and of~     the etiology of RP.~   "
96056|NCT02309853|"~     The purpose of this study is to evaluate whether 20 Sessions of 30 minutes with a visual and~     tactile scanning training in the personal, peripersonal and extrapersonal space combined with~     trunk rotation will be feasible and provide better results compared to 20 Sessions of 30~     minutes of a standard visual scanning programme.~   "
96057|NCT02309840|"~     The purpose of this study is to examine the impact of introducing healthier, chef-enhanced~     foods and/or environmental modifications (choice architecture) on selection and consumption~     of school foods among elementary and middle school students.~   "
96058|NCT02309827|"~     This study is a first in human study of PF-06651600. PF-06651600 is being developed for~     treatment of inflammatory bowel disease. This study will test single and multiple doses of~     PF-06651600. The goal of the study is to assess the safety, tolerability, pharmacokinetics~     and pharmacodynamics of PF-06651600 in healthy volunteers.~   "
96059|NCT02309814|"~     The investigators have developed a simple to use device that facilitates the monitoring of~     the upper eyelids motion, acquires the eyelid vertical movement and enables analysis and~     graphic presentation of the results. the device system consists 3 components : glasses for~     the patient including magneto sensitive probes, hardware and dedicated software.~      Our purpose is to characterize eyelid motion in normal population. The methods include~     measuring each patient 10 minutes during watching a short movie.~   "
96060|NCT02309801|"~     The main objective is to assess whether a natural inhibitor of aldehyde dehydrogenase 2~     (ALDH2) contained in a soy extract could interfere on alcohol metabolism and effects in~     humans.~   "
96061|NCT02309788|"~     Hepatocellular carcinoma (HCC) is one of ten leading cancer types worldwide and also in Asia,~     but the five-year relative survival rate is relatively quite low1-3. As a common complication~     of HCC, portal vein tumor thrombosis (PVTT) have been reported with an occurrence of 34% ~~     50% in advanced HCC and it is now become an extremely pressing problem for hepatic surgeon.~     Nevertheless, the patients overall survival (OS) varies on their clinical features or liver~     function4. For HCC PVTT treatment, current options are surgical resection, embolization~     chemotherapy, radiation therapy, a variety of ablation therapy, biological and gene~     therapy,etc. Among them, the use of radiation therapy is getting more and more attention, and~     it is changing from the past palliative treatment to current curable treatment. From an~     oncologic point of view, a narrow margin <1 cm is not safe and is often associated with~     higher rates of recurrence and shorter patient survival.On the other hand, it is also~     believed that most intrahepatic recurrences arise from multicentric carcinogenesis and are~     distant from the resection margin.To address this issue, the investigators are going to~     conduct a series of retrospective and prospective studies to investigate the effect of~     adjuvant RT for centrally located HCC after narrow margin (<1 cm) hepatectomy on tumor~     recurrence.~   "
96062|NCT02309775|"~     Objectives: Verify the effect of auriculotherapy in patients with tension-type headache~     resulting from temporomandibular dysfunction.~      Design: Randomized clinical study Setting: Randomized Study Participants: The study consist~     of 38 participants randomized into two groups: an intervention group (n = 18, sample loss =~     1) and placebo group (n = 20, sample loss = 6) Interventions: The intervention group will~     receive treatment with auricular acupuncture in the Shen Men, Kidney, Sympathetic, Subcortex,~     Adrenal and Cerebral points. The placebo group will receive auriculotherapy in the trachea~     point.~      Main outcome measures: visual analog scale for pain pain (VAS) and surface electromyography~     (EMG).~   "
96063|NCT02309762|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and~     immunogenicity of single-ascending IV doses of FB825~   "
96064|NCT02309749|"~     This is a pilot to review the feasibility of a program that assists patients towards therapy~     compliance by scheduled intervention through the first month of therapy. The hypothesis of~     this study is that the trial program will function as intended and average patient adherence~     will be over 4 hours per night.~   "
96065|NCT02309736|"~     This is a prospective multicenter observational single arm post-approval registry that will~     collect post-approval data relative to the incidence of endophthalmitis for cataract surgery~     patients treated with the FDA-approved ReSure Sealant when used by a broad group of~     physicians under commercial use conditions.~   "
96066|NCT02309723|"~     When older patients develop cognitive problems - like memory loss - there may be any of~     several underlying causes, sometimes occurring in combination. Clinicians have a better~     chance of providing appropriate treatment if they understand what the cause of the problem~     is. A diagnostic tool can help the patient by helping the clinician to make a more accurate~     diagnosis. This study investigates whether a new diagnostic tool - beta amyloid imaging - may~     potentially improve medical practice. The tool can potentially improve practice only if it~     can influence clinical judgment. This study investigates whether the provision of beta~     amyloid imaging information influences clinical judgment. The investigators will conduct a~     survey that presents clinicians with descriptions of hypothetical older patients with~     cognitive complaints. Some of the respondents also receive beta amyloid imaging information.~     The investigators will test the investigators hypothesis that the information will affect~     diagnostic judgment and management recommendations by comparing the responses of clinicians~     who receive the beta amyloid information to the responses of clinicians who do not.~   "
96067|NCT02309710|"~     This prospective study will evaluate the safety and acceptability of the ShangRing device for~     medical male circumcision (MMC) during routine service delivery in Namitete, Malawi~   "
96069|NCT02309684|"~     The purpose of this study is to assess the performance of the bio-ConneKt™ wound dressing and~     compare its performance with the standard of care at NFRMC Wound Therapy Services, for the~     treatment of chronic foot/leg ulcers (DFU/VLU) in a prospective single center open one-arm~     clinical study.~   "
96073|NCT02309632|"~     100 subjects who have a family history of pancreatic cancer (PC), or known genetic syndromes~     associated with increased risk of pancreatic cancer, will be followed for five years. This~     data will be used to determine the pancreatic cancer and precancerous lesion detection rate~     in High Risk Individuals (HRIs). Subjects may agree to annual imaging and annual biomarkers~     or to biomarkers only.~   "
96074|NCT02309619|"~     Esophageal cancer (EC) is the eighth most common cancer and the sixth leading cause of cancer~     deaths worldwide. Minimally invasive esophagectomy (MIE) is regarded as a safe and effective~     management for resectable EC. Gastric tube is considered to be an ideal substitute for the~     resected esophagus and can be lifted to the neck for anastomosis through two different paths~     — Trans-substernal and trans-esophageal bed routes. However, the differences of operative~     outcomes between the two paths have not been systematically described. In this study,~     clinical outcomes including intra- and post-operative status, morbidity and complications,~     nutrition status, as well as quality of life after surgery will be evaluated, and differences~     between the trans-substernal and trans-esophageal bed groups will be compared. The study~     might help to individualization treatment for EC.~   "
96075|NCT02309606|"~     Migraine affects 16% of the world population and is one of the most disabling of all~     disorders. It is a complex brain disorder characterized primarily by recurrent headache~     attacks. The signaling molecule serotonin (5-hydroxytryptamine, 5-HT) has for decades been~     thought to play a central role in migraine pathophysiology. The most effective class of~     abortive migraine drugs, the triptans, act on 5-HT receptors. However, the migraine-specific~     actions of serotonin and the mechanisms of triptans are still unknown. In this project the~     investigators will use high-resolution positron emission tomography and specific radioligands~     to investigate the significance of serotonin in migraine. Two newly developed radioligands~     that are specific for the 5-HT1B and 5-HT4 receptor, respectively, will be applied. To~     investigate the level and distribution of serotonin in the migraine brain the investigators~     will compare the binding of these ligands in episodic migraine patients with healthy~     controls. In addition, the investigators will include chronic migraine patients to evaluate~     the relation between the level of serotonin in the brain and the frequency of migraine~     attacks. To investigate the changes in the serotonin level during a migraine attack and the~     effects of triptans on the central nervous system the investigators will repeat the scans~     using the 5-HT1B specific ligand during induced migraine attacks and following treatment with~     sumatriptan. The results from this study will shed light on the role of serotonin in the~     migraine brain and elucidate the migraine-specific action of triptans. This will improve our~     understanding of the migraine pathophysiology and, potentially, facilitate the development of~     more efficient treatment of migraine.~   "
96076|NCT02309593|"~     MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to~     evaluate the safety and efficacy of its total hip arthroplasty (THA) and resurfacing~     components marketed in the European Union (EU). These types of studies are required by~     regulatory authorities for all THA and resurfacing devices that do not have medium to~     long-term clinical evidence available at the time of gaining approval to market in the EU.~     This study has been designed in accordance with the medial device directives (MEDDEV) 2.12/2~     rev 2.~   "
96077|NCT02309580|"~     This is a Phase 1 clinical trial, a type of research study. The purpose of this phase 1~     clinical trial is to find out whether a new study drug, ibrutinib, is safe in patients with~     T-cell non-Hodgkin lymphoma that has either come back or not responded to treatment. In this~     phase 1 study, different doses of ibrutinib (560 mg and 840 mg daily) will be tested to see~     what effect the drug has on the patient and the disease.~   "
96078|NCT02309567|"~     p53 is a tumor suppressor gene which plays an important role in controlling normal cell~     proliferation regulation that is located on the chromosome 17 (17p13.1). It is the most~     common goal of genetic alteration in many tumors. Serum p53 protein is presence in normal~     healthy individuals. However p53 antibody is extremely rare. Mutations in this gene cause an~     accumulation of non-functional proteins and development of anti-p53 antibodies, which can be~     detectable in tissues, slouhed cells, blood and other body fluids. Some studies have reported~     that, p53 mutations are highly common in leukemia, lymphoma, lung, esophagus, stomach, liver,~     bone, bladder, ovarian, and brain cancers. Lung cancer is the most common cause of~     cancer-related deaths and the survey is low after the initial diagnosis. Accurate staging is~     important for determine the choice of treatment and predict prognosis. 18F-FDG PET/BT has~     important value for initial staging and it is the most advanced imaging technique developed~     all over the world for determine of the characterization of the metabolic tumor volume.~     Maksimum Standardized Uptake Value (SUVmax) which was acquired by PET imaging is commonly~     used in clinical practice as a criterion for malignancy. Due to the development of new~     software programs recently studies have shown that metabolic tumor volume (MTV) and total~     lesion glycolysis (TLG) may be useful quantitative parameters for the prognostic evaluation.~     Viable tumor volume could be estimate with this programs.The purpose of this study was to~     assess the relation between serum anti-p53 antibody level and quantitative PET parameters as~     SUVmax, SUVave, MTV and TLG.~   "
96079|NCT02309554|"~     This post coital test study is a Phase I multi-center, randomized, crossover, non-significant~     risk device study to be carried out at two clinical sites/centers. The products to be tested~     are the SILCS diaphragm with 3% Nonoxynol-9 Gel (N-9) (spermicide), the SILCS diaphragm with~     ContraGel, and the SILCS diaphragm alone. Participants will be randomized to the order of~     product use, with a goal of 10 participants completing the study.~   "
96080|NCT02309541|"~     The purpose of this study is to evaluate audio quality benefit for the patient implanted with~     a Cochlear or Otologics Carina implant with the new firmware (feedback canceller algorithm)~     whatever the patient environment is and to evaluate the functional gain and speech~     understanding benefit for the patient upon the firmware used (new and reference firmware).~     The new firmware aims to adapt automatically for feedback cancellation without prior~     calibration.~   "
96094|NCT02309359|"~     The purpose of this study is to assess the efficacy and safety of dose regimens of ALX-0061~     administered subcutaneously (s.c.) in combination with methotrexate (MTX) to subjects with~     active RA despite MTX therapy, compared with placebo.~      To assess the effects of ALX-0061 on quality of life, pharmacokinetics (PK), pharmacodynamics~     (PD), and immunogenicity of ALX-0061, and to define the optimal dose regimen for ALX-0061,~     based on safety and efficacy, for further clinical development.~   "
96081|NCT02309528|"~     Few educational intervention clinical trials have been conducted among those at risk for or~     with early chronic kidney disease. To the investigators' knowledge none have used digital~     storytelling as a means to deliver the educational message and have been conducted among~     American Indians, a group with high prevalence of chronic kidney disease and end stage kidney~     disease.~      The aims of the research project are to:~        1. Quantify levels of chronic kidney disease knowledge and awareness among American~          Indians.~        2. Determine the effectiveness of a culturally tailored health presentation with~          computerized digital stories made by American Indians for improving chronic kidney~          disease knowledge and factors thought to be preventative of chronic kidney disease or~          its progression at baseline and follow-up in a pilot educational clinical intervention~          trial.~   "
96082|NCT02309515|"~     This randomized phase II trial studies how well lenalidomide improves immune response to~     pneumococcal 13-valent conjugate vaccine in patients with chronic lymphocytic leukemia, small~     lymphocytic lymphoma, or monoclonal B cell lymphocytosis. Biological therapies, such as~     lenalidomide, use substances made from living organisms that may stimulate or suppress the~     immune system in different ways and stop cancer cells from growing. Lenalidomide may also~     improve the effectiveness of pneumococcal 13-valent conjugate vaccine that is used to prevent~     infection.~   "
96083|NCT02309502|"~     Diabetic retinopathy (DR) is a leading cause of new cases of blindness in people aged 20 to~     65 years worldwide.~      Patients with DR may go on to develop a more severe form of the disease called Proliferative~     Diabetic Retinopathy (PDR), a condition in which abnormal new blood vessels may rupture and~     bleed inside the eye. When this advanced stage of retinopathy occurs, pan-retinal~     photocoagulation (laser treatment) is usually recommended.~      The purpose of the investigators study is to find if treating patients using a single session~     of lower intensity laser (Pascal® Pan Retinal Photo-Stimulation, P-RPhS) at an earlier stage~     in Diabetic Retinopathy (during the severe non-proliferative diabetic retinopathy stage) when~     the abnormal new vessels are not developed, will prevent diabetic patients to develop PDR.~      Patients included in the study will be randomized in three arms (randomization). In one arm~     patients will be treated with the normal parameters used in Pascal® laser, the second arm~     patients will be treated with a lower intensity than normal, using the Endpoint management~     system (a new software from the Pascal® laser which allow us to decrees the intensity of the~     burns (invisible burns) showing some landmarks with normal intensity so the area which has~     been treated can be viewed. And in the third arm the patients will be observed.~   "
96084|NCT02309489|"~     The uptake of postpartum contraception, postpartum care attendance and the practice of~     exclusive breastfeeding are low in Sub-Saharan Africa. Although the involvement of men in~     maternity care has been shown to be a promising strategy for the achievement of other~     reproductive health goals, little is known about the effect of their participation on these~     outcomes. This study aims to test whether the involvement of men can improve care-seeking and~     promote healthy behaviours among postpartum women in Burkina Faso.~   "
96085|NCT02309476|"~     Topcon's Endpoint Management (EM) is a new software from the Pascal® laser which allows us to~     decrease the intensity of the burns (invisible burns) showing some landmarks with normal~     intensity so the investigators can see the area which has been treated. The Pascal® system~     with EM utilizes 577nm laser wavelength compared to the 532nm laser wavelength which was~     utilized in previous Pascal® laser studies.~      This study aims to demonstrate that 577nm Pascal® with EM has the same efficacy and~     effectiveness as 532nm Pascal® in the treatment of diabetic macular oedema.~   "
96086|NCT02309463|"~     The objective of the study is to monitor physical activity longitudinally with a wrist~     activity tracker specifically in PAH patients newly initiating ERA therapy and to assess the~     correlation with the 6MWD at different time points. Further objectives are to assess the~     correlation of physical activity measured with the tracker and other parameters for clinical~     evaluation and right ventricular function assessment (i.e. Biomarkers, WHO Functional class,~     hospitalization due to PAH, Echochardiography and Quality of Life) as well as sleep efficacy~     in PAH patients newly initiating ERA therapy.~   "
96087|NCT02309450|"~     ANRS HC 33 is a pilot study to assess efficacy and safety of a DCV 3DAA therapy with~     Asunaprevir, Daclatasvir and BMS-791325 in HCV genotype 4-infected patients after failure of~     pegylated Interferon-Ribavirin regimen.~      Proportion of patients with cirrhosis will be limited to 50% of all patients included,~     cirrhosis being defined as a METAVIR score of F4 on the liver biopsy or an hepatic impulse~     elastometry ≥ 14 kPa or a Fibrotest® result > 0,75.~   "
96088|NCT02309437|"~     The present study is a superiority research, to evaluate the nutrition status, quality of~     life, influence on clinical outcome, and the adverse effects of the early use of OxyContin on~     the pain induced by radiation oral mucositis in nasopharyngeal carcinoma patients.~   "
96089|NCT02309424|"~     This open, randomized, cross-over, placebo-controlled study aims to investigate the effects~     of vinegar on glucose metabolism, endothelial function and circulating lipid levels in~     subjects with impaired glucose tolerance or type 2 diabetes, using the arteriovenous~     difference technique.~   "
96090|NCT02309411|"~     The purpose of this study is to find out whether rivaroxaban is safe to use in children and~     how long it stays in the body. Safety will be assessed by looking at the incidence and types~     of bleeding events. There will also be a check for worsening of blood clots.~   "
96091|NCT02309398|"~     The purpose of this study is to develop and implement quality improvement programs for the~     treatment of atrial fibrillation (AF) in China based on the successful experience of the~     AHA‐Get with the Guidelines program. This two-year program will use data collection,~     analysis, feedback, and process improvement to extend the use of evidence-based guidelines~     throughout the healthcare system and improve patient care of atrial fibrillation.~   "
96092|NCT02309385|"~     The purpose of this study is to determine the efficacy, safety, and tolerability of~     dexamethasone sodium phosphate Visulex (DSP-Visulex) after repeated-dose administration in~     patients with acute anterior uveitis.~   "
96093|NCT02309372|"~     This trial will determine if depression treatment will reduce cardiovascular risk in~     HIV-infected patients already receiving HIV treatments. Half of the participants will undergo~     a specific computerized depression treatment with the other half receiving usual care from~     their HIV providers.~   "
96096|NCT02309333|"~     Acute promyelocytic leukemia (APL) is a very rare type of leukemia. Because it is so rare,~     many doctors do not have experience treating it. APL has been shown to be curable most of the~     time. Unfortunately, some patients die early after they become sick with APL, sometimes even~     before starting treatment. The early period is from the time of diagnosis through the first~     treatments for the disease. This is approximately 30 days. Early deaths are often due to~     complications caused by of the effects of leukemia and the treatments of it. These~     complications may not be noticed quickly by doctors who don't have much experience with~     managing APL.~      The purpose of this study is to collect information about the diagnosis and management of APL~     patients by review of their medical records. This information will be stored in a central~     database at Emory University. This data will be analyzed to discover the impact of increased~     physician knowledge of recommended management of APL. The goal is to reduce the events of~     early death of APL patients.~   "
96097|NCT02309320|"~     The primary objective of the study is to investigate the safety and tolerability of ALX-0171.~      The secondary objectives are to evaluate the clinical effect of ALX-0171 and to explore the~     pharmacodynamics (PD) and the systemic pharmacokinetics (PK) of ALX-0171.~   "
96098|NCT02309307|"~     The VergenixTM STR device is intended for the repair of non ruptured tendon injuries~     (Tendinopathy).~   "
96099|NCT02309294|"~     The objective of this study is to determine the ability of the study material to cause~     irritation to the skin of humans under controlled patch test conditions. Substances that come~     into contact with human skin need to be evaluated for their propensity to irritate and/or~     sensitize. This testing is a modified primary irritancy patch test that can detect weak~     irritants that require multiple applications to cause a skin reaction.~   "
96100|NCT02309281|"~     Title: Intravitreal aflibercept (VEGF Trap-Eye) in neovascular age-related macular~     degeneration with limited response to ranibizumab~      Purpose: The purpose of this investigator initiated study is to identify the duration of~     treatment effects of intravitreal aflibercept on sub- and intraretinal fluid and best~     corrected visual acuity (BCVA) in choroidal neovascularizations (CNV) due to age-related~     macular degeneration (AMD) in which the Optical coherence tomography (OCT) guided treatment~     interval failed to be extended to 6 weeks intervals in a treat and extend regimen.~      Objectives: The primary objective is to evaluate the mean maximum recurrence-free treatment~     interval (Imax in weeks) with aflibercept treatment during the 24 months study peroid (for~     explanation see section Objectives). The individual maximum recurrence-free treatment~     interval (in weeks) at 24 weeks is defined as the maximum extension interval which is reached~     during the study follow-up period without showing any CNV activity (any intra-or subretinal~     fluid at OCT or new retinal hemorrhage). This measure reflects the duration of aflibercept~     effect in these lesions with limited response to ranibizumab. Key secondary Outcome Measures~     are mean changes in BCVA score at 24 weeks from baseline (Δ BCVAscore), mean changes in CRT~     (µm) at 24 weeks from baseline (Δ CRT), mean number of treatments needed during the 24 weeks~     study follow-up, number of participants with adverse events and serious adverse events (for~     further outcome measures see section Objectives).~      Population: This outpatient study population will consist of a representative group of 33~     male and female patients ≥ 50 years of age. The study population will include patients with~     subfoveal CNV secondary to AMD and being pre-treated with intravitreal ranibizumab in a treat~     and extend regimen and failed to be extended to 6-weeks intervals without showing CNV~     activity (for further information see section Criteria).~      Interventions: 1-arm interventional study with 2mg aflibercept intravitreally up to 4-weekly.~     The first treatment interval with aflibercept will be 4 weeks and corresponding to the treat~     and extend regime intervals will be increased in 2-weeks-steps as long as no CNV activity~     (any intra-or subretinal fluid at OCT or new retinal hemorrhage) occurs. In case of occuring~     CNV activity the interval is shortened by 4 weeks with a minimum treatment interval of 4~     weeks.~   "
96101|NCT02309268|"~     The purpose of this research is to monitor how well patients do after surgery for treatment~     of left atrial appendage (LAA).~   "
96102|NCT02309255|"~     The NOR-COR study is a cross-sectional, observational study designed to explore a large~     number of cardiovascular, inflammatory, genetic, behavioral, and psychosocial factors~     (including anxiety, depression, quality of life) in 1369 patients with established coronary~     heart disease (CHD) hospitalized in the Sections for Cardiology at the hospitals in Drammen~     (n=722) and Vestfold (n=647). Study data from an extensive questionnaire, clinical and~     laboratory data, and sputum/saliva for genetic analyses will be collected.~      The main overall aim of the NOR-COR study is to develop new strategies to improve secondary~     prevention for underserved high risk patient-groups with CHD. The first study phase aims to~     collect information necessary to develop empirically based future secondary coronary~     prevention interventions. In a genetic sub-project markers associated with CHD and~     personality type will be explored.~      The study will evaluate current secondary preventive programs and explore the mechanisms that~     link behavioral, psychosocial, inflammatory, and genetic factors to poor prognosis. The study~     will in short term provide new knowledge potentially useful for increasing participation in~     current cardiac rehabilitation/secondary preventive programs. For a longer perspective these~     associations may be useful for design of new intervention programs to selected high risk~     patient groups whom may be in need of programs with different content and/or of longer~     duration than those currently being applied.~   "
96103|NCT02309242|"~     The aim of the proposed project is to study the long-term impact of adjuvant systemic multi-~     agent chemotherapy (cisplatin, anthracyclines, vincristine, methotrexate, alkylating agents)~     in survivors (treated between 1992 and 2014 in UZ Leuven) of paediatric bone or soft tissue~     sarcomas on neurocognitive functioning.~   "
96104|NCT02309229|"~     To use the sputum colour chart as a predictor for cystic fibrosis exaerbations~   "
96105|NCT02309216|"~     The purpose: to pilot whole-body MRI scanning in infants who are already getting brain MRI~     for suspected child abuse~      Research design: prospective, blinded reading of Whole-Body MRI (WB-MRI) images during the~     routine care of the hospitalized infant with comparison to routine radiographic skeletal~     survey images~      Procedures to be used: whole-body MRI images~      Risks and potential benefits: no additional risk (the infant will be receiving and MRI of~     their brain as part of routine care, the additional images will be obtained at the same time~     without additional sedation); benefits to the infant include the identification of injuries~     which would have otherwise been missed by routine care importance of knowledge that may~     reasonably be expected to result: results from this study will potentially influence the use~     of radiographic skeletal survey and decrease the radiation exposure to infants being~     evaluated for suspected child abuse.~   "
96106|NCT02309203|"~     The study objective is to evaluate the safety and effectiveness of the MicroVention FRED~     System when used in the treatment of wide-necked intracranial aneurysms.~   "
96107|NCT02309190|"~     The study consists in determine the transpulmonary pressure in morbidly obesity patients that~     require mechanical ventilation.~        -  both gender~        -  only adults~        -  Medical intensive care patients.~   "
96108|NCT02309177|"~     The purpose of this study is to assess safety of nab-paclitaxel based chemotherapy regimens~     administered prior to and/or in combination with nivolumab in Pancreatic Cancer, Non Small~     Cell Lung Cancer (NSCLC) and Metastatic Breast Cancer (mBC).~   "
96110|NCT02309151|"~     The overall aim of this prospective, randomized pilot study is to investigate whether acute~     coronary angiography (within 120 minutes) with a predefined strategy for revascularization,~     is safe to implement in patients with out of hospital cardiac arrest. The primary question at~     issue is whether early angiography (within 120 minutes) with a predefined strategy for~     revascularization with percutaneous coronary intervention (PCI) is safe to carry out in this~     group of patients. The patients randomized to acute coronary angiography will be compared~     with a control group who will be treated according to standard practice with coronary~     angiography with possible subsequent intervention according to the current routine, which~     usually does not occur within the first three days after cardiac arrest.~   "
96111|NCT02309138|"~     This is a single site blinded RCT of 920 pregnant women with singleton gestation designed to~     compare the Carpenter-Coustan and IADPSG criteria for diagnosing gestational diabetes.~     Maternal metabolic profiles and infant growth will be assessed at randomization and at one~     year postpartum.~   "
96112|NCT02309125|"~     The aim of this split mouth study is to compare which method is better in reducing bone loss~     and healing times following implants. Specifically, the two methods investigated will be~     immediate gradual loading and early loading protocol.~      Research Hypothesis Immediate gradual loading using gingival formers is superior to early~     loading protocols in improving bone quality and thus reducing the healing time.~   "
96113|NCT02309112|"~     A feasibility study to determine the appropriateness of yoga intervention to improve~     health-related quality of life in adult cancer patients.~   "
96114|NCT02309099|"~     The goal of this project is to determine whether subjects who have undergone labyrinthectomy~     or a translabyrinthine surgical approach as the treatment for vestibular schwannoma or~     Meniere's disease benefit from cochlear implantation on speech perception and localization~     tasks.~      If the auditory nerve is able to transmit this signal effectively, then these two populations~     may be able to utilize the combination of electric (in the affected ear) and acoustic (in the~     non-affected ear) information for improved speech perception in noise and localization as~     reportedly experienced in other unilateral sensorineural hearing loss populations.~   "
96115|NCT02309086|"~     Dendritic cells (DC) play a central role in the activation of T-cell responses and have shown~     to be very immunogenic in preclinical in vivo and in vitro assays. The aims of this study is~     to assess the efficacy of therapeutic vaccination pilot clinical trial in Genotype 1 HCV~     patients using autologous DC transduced with a recombinant adenovirus encoding NS3~   "
96116|NCT02309073|"~     Background: Despite considerable progress in the field of assisted reproductive technology~     (ART) maximum pregnancy rates generally do not exceed 30%. Furthermore, substantial~     differences in pregnancy rates are seen between women starting ART from seemingly similar~     clinical starting points and information on pregnancy/neonatal complications after ART is~     limited. For physicians and patients it would be extremely valuable if tools could be~     developed through which individualised chances of live birth and the development of~     pregnancy/neonatal complications can be calculated. In addition, there is increasing~     knowledge about health risks associated with subfertility and in particular with polycystic~     ovarian syndrome (PCOS) and premature ovarian failure (POF). An important void in research to~     date is the absence of a control group to check important new findings.~      Objectives: The study protocol aims to form a cohort of normo-ovulatory women with a regular~     indication for ART which can aid the investigators principle lines of research:~        1. To study initial predictors of ovarian response to stimulation for IVF~        2. To study predictors of chances for live birth after repeated IVF cycles~        3. To assess the role for vascular health in the probabilities of success in ART treatment~        4. To study predictors for pregnancy and neonatal complications~        5. To form a control group for cycle disturbance studies~      Study design: In this part of the protocol, serum and material for DNA analysis will be~     collected by asking patients to have 20 ml of blood drawn during a routine blood withdrawal.~     This blood will be stored in the Biobank of the UMC Utrecht at -80 C.~      Study population: All women starting ART will be asked to participate.~      Nature and extent of the burden and benefits associated with participation: There are no~     benefits or risks for the study patient as blood is withdrawn during a routine venapuncture~     and results will not be used for clinical practice.~   "
96117|NCT02309060|"~     The overall aim of this program of research is to develop a collaborative narrative~     intervention for patients with depression being treated in primary care.~      The purpose of the proposed project is to establish the feasibility, acceptability, and~     preliminary effects of our newly developed narrative intervention on depression.~      To achieve the specific aims, the investigators will conduct an open trial to further develop~     and refine the intervention (n = 10).~   "
96118|NCT02309047|"~     Through the COLA Study and Biobank the investigators hope to enable further identification of~     phenotype, endocrine, ethnic, and metabolic characteristics associated with menstrual cycle~     disturbances; and: the identification of genetic or other etiologic factors associated with~     cycle disturbances.~   "
96119|NCT02309034|"~     Objective: To compare the results of two types of low-impact exercise training, in and out of~     the water, with the control group, regarding cardiometabolic risk factors in overweight~     adolescents; and to investigate the changes resulting from interventions in biochemical,~     anthropometric, psychological variables and body composition.~      Experimental design: Randomized clinical trial with overweight and obesity adolescents.~      Local Search: College of Physical Education of Federal University of Rio Grande do Sul and~     Hospital de Clinicas de Porto Alegre, city of Porto Alegre, Rio Grande do Sul State, Brazil.~      Participants: Took part in the study 75 overweight and obesity adolescents, pubertal and~     post-pubertal, recruted by announcement in the most important newspapers of Porto Alegre~     city.~      Intervention: Adolescents that acepted to participate in the study, and authorized by their~     parents, were randomized into three groups: Group Land / Jump, with three weekly sessions~     Jump; Water / hidrogimnastic group, with three weekly sessions of hidrogminastic; Control~     group that not participate in physical exercise intervention. The intervention will last 12~     weeks and three groups participate in weekly sessions of nutritional guidance. Assessments~     occur at the beginning of the intervention program and 72 hours after the 12th week of the~     program. The results of all study variables among the three groups in the two time points,~     and in each group between the two periods, will compared.~      Measures: Anthropometric, biochemical and blood pressure evaluations, in addition to applying~     instruments for assessing quality of life, body image and mental health by experienced~     evaluators, as well as blood draws conducted by an experienced gatherer's Hospital de~     Clínicas de Porto Alegre.~      Expected Results: In the study, are been expected to verify that the exercise programs,~     aquatic and land, associated with nutritional guidance, are efficient to modify positively~     the outcomes studied.~   "
96120|NCT02309021|"~     The aim is to examine the effect of exercise (EX) training on individuals currently receiving~     ST - either opiate replacement therapy (ORT) or heroin-assisted treatment (HAT) - for their~     opiate dependence. Main outcome variables will be: cardiovascular fitness; consumption of~     substances (e.g. street heroin, cocaine, cannabis, alcohol, cigarettes) other than~     prescribed ST or other prescribed medications; substance craving; blood pressure; lung~     function; resting pulse; social interaction; self-control capacity; objective and subjective~     sleep; cortisol levels; quality adjusted life years (QALYs); depression; mood. Covariates are~     current substitution dose and psychiatric diagnoses.~   "
96121|NCT02309008|"~     The purpose of this study is to investigate the safety/tolerability and pharmacokinetics of~     PAC-14028 cream after transdermal administration in healthy male volunteers.~   "
96123|NCT02308982|"~     This is a phase III multi-centre randomised, double blind, placebo controlled trial to assess~     the role of intravenous immunoglobulin in the treatment of children with encephalitis. The~     primary objective is to find out whether early use of IVIG treatment improves neurological~     outcomes of children with encephalitis.~      308 children with encephalitis, aged 6 weeks to 16 years will be recruited in 30 hospitals in~     the United Kingdom. Participants will be randomised to receive two doses of IVIG or matching~     placebo in addition to other standard treatments, within the first five days of hospital~     admission.~      Each participant will be followed up for 12 months. During this period, information on~     clinical, radiological and laboratory investigations will be collected. Neurological outcomes~     will be assessed by the use of questionnaires at 6 and 12 months, and a neuropsychological~     assessment at 12 months.~   "
96124|NCT02308969|"~     The aim of the present study is to assess the neuronal correlates of alterations in waking~     consciousness pharmacologically induced by a 5-hydroxytryptamine (HT)2A receptor agonist in~     healthy subjects using functional magnetic resonance imaging (fMRI).~   "
96125|NCT02308956|"~     Task sharing mental health care through integration of mental health into primary health care~     (PHC) is advocated as a means of narrowing the treatment gap for mental disorders in~     low-income countries. In Ethiopia, it is estimated that only around 10% of people with severe~     mental disorders (SMDs) ever receive evidence-based treatment for their condition, largely~     due to scarcity of specialist mental health services. A task-sharing model of mental health~     care in PHC would be more affordable and accessible to the majority of persons with SMD who~     do not currently receive evidence-based mental health care. Furthermore, task sharing mental~     health care with PHC is about to be scaled up in Ethiopia in line with the National Mental~     Health Strategy. However, the effectiveness of the task sharing model of mental health care~     for people with SMD has not been evaluated systematically in a low-income country. In this~     study we propose to investigate non-inferiority of a task sharing model of mental health care~     in PHC compared to a less accessible, but more specialist, psychiatric nurse-led model of~     care. The specialist model of care has been demonstrated to be acceptable and associated with~     improved clinical outcomes for persons with SMD engaged in the service in Ethiopia thus~     making this an appropriate comparison model against which to evaluate non-inferiority of the~     task sharing model.~   "
96126|NCT02308930|"~     The purpose of this study is to determine whether DHA supplement (in a daily dose of 300 mg)~     will improve the cognitive performance, associated metabolism and growth in normal children~     aged 6-12 years in primary schools.~   "
96127|NCT02308917|"~     The initial network clinical study will be an inception cohort study in children with new~     onset IBD (Inflammatory Bowel Disease) rigorously phenotyped and prospectively followed.~     Focusing on a prospective, inception cohort of Canadian children of widely varied racial~     origins provides a unique opportunity to explore environmental risk factors early in life and~     close in time to disease onset, their influence on the host microbiome, and in the context of~     genetic susceptibility. In keeping with current treatment targets, assessed outcomes will~     include not only symptom resolution and growth, but also intestinal healing. Anticipated~     variation between network sites in choices of evidence-based therapies, even among~     phenotypically similar sub-types of Crohn disease and ulcerative colitis, will allow~     comparisons outcomes with disparate treatments, aiming to identify best practice and to~     institute processes for continual improvement in care nationally.~   "
96128|NCT02308904|"~     The improved long-term survival of thalassemia major (TM) patients has resulted in increased~     focus on the ability to preserve fertility. While the association of iron toxicity with vital~     organ dysfunction, heart and liver, has been extensively investigated, the correlation of~     reproductive capacity and extent of iron overload is not well understood. Despite remarkable~     progress in methodology for prediction of reproductive status and intervention for preserving~     fertility, implementation in thalassemia is lacking.~      The investigators hypothesize that iron toxicity to the anterior pituitary occurring in the~     process of transfusional iron loading is directly associated with a decline in gonadal~     function. The investigators expect pituitary MRI measurements of iron deposition as well as~     markers of oxidative damage to correlate with the functional studies of pituitary-gonadal~     axis performed in this study. This cross sectional study will examine the relation of~     pituitary iron deposition and pituitary volume; serum iron and oxidative stress measures,~     liver iron concentration (LIC), cardiac iron and chelation adequacy with pituitary and~     gonadal reproductive hormone levels (and spermatogenesis in adult male patients), in order to~     better define the association of iron burden and chelation patterns with fertility potential,~     in thalassemia patients with iron overload. The study will assess whether the current~     chelation treatment regimens, in particular during the pubertal developmental age, are~     adequate for preserving fertility and could lead to improved chelation routines for~     preventing the high prevalence of compromised fertility. In addition, by utilizing~     state-of-the-art markers for fertility status, findings from this study may improve current~     methods for screening for hypogonadism and reproductive potential and allow earlier~     intervention.~      The investigators propose to examine 26-30 patients, 12 years and older, with measures of~     fertility potential, and correlate them to their current iron burden parameters and to the~     cumulative iron effect as indicated by past iron overload patterns and chelation history.~   "
96129|NCT02308891|"~     Postendoscopic retrograde cholangiopancreatography pancreatitis is the most frequent and~     serious complication of ERCP procedures, occurring in approximately 5-15% of unselected~     patients. Pharmacologic prevention of post-ERCP pancreatitis has been the topic of several~     investigations in recent years. Hydration is considered a mainstay of treatment for acute~     pancreatitis. We perform multicenter, prospective, randomized trial to investigate whether~     intravenous vigorous hydration with lactated Ringer's solution reduces the risk of post-ERCP~     pancreatitis.~      Inclusion criteria : consecutive patients older than 18 years who are scheduled to undergo~     diagnostic or therapeutic ERCP will be recruited.~      Patients will be randomly assigned in a 1:1 ratio to receive either vigorous hydration~     (treatment arm) or standard hydration (standard arm). Randomization will be performed in a~     double blinded fashion using computer-generated random numbers.~      Treatment arm (vigorous hydration arm);~        -  Initial bolus of lactated Ringer's solution at 10 mL/kg over 1 hour prior to ERCP~        -  Intravenous lactated Ringer's solution at a rate of 3 mL/kg/h during the procedure and~          continued for 8 hours.~        -  At the end of ERCP, post-procedure bolus of lactated Ringer's solution at 10 mL/Kg over~          1hour Standard arm (standard hydration arm);~        -  Patients will receive lactated Ringer's solution at the start of the ERCP and the fluids~          will be administered at a rate of 1.5 ml/kg/h during the procedure and for 8hours after~          ERCP.~      The primary endpoint was development of post-ERCP pancreatitis, which define as increased~     pancreatic pain (more than 3 on a visual analogue pain scale) and hyperamylasemia (three~     times the upper limit of normal).~      The secondary endpoint included the development of asymptomatic hyperamylasemia, severity of~     pancreatitis, and fluid overload.~   "
96130|NCT02308878|"~     Heroin use has been related to brain dysfunction particularly in the prefrontal cortex. These~     effects are evident in neuropsychological impairments in attention, memory and executive~     functioning of heroin users. To assess these deficits and the application of a novel approach~     of cognitive stimulation to heroin users in treatment for opioid dependence, we have carried~     out a neuropsychological intervention program with mobile health technology. Patients~     diagnosed with opioid dependence were submitted to cognitive stimulation during four weeks in~     a three-day/week basis.~   "
96131|NCT02308865|"~     Single-center, prospective, controlled, open-label, randomized, two parallel arms comparing~     early Palliative care versus Standard care in patients with non-small-cell metastatic lung~     cancer~   "
96132|NCT02308852|"~     Noninvasive brain stimulations (NIBS) will be used in healthy volunteers and in chronic~     stroke patients to improve bimanual activities and motor learning.~      Functional magnetic resonance imaging will be used to evaluate the mechanisms underlying~     bimanual activities and motor learning in healthy volunteers and in chronic stroke patients.~      A neuro-rehabilitation robot (REA2PLAN, AXINESIS, Louvain-la-Neuve, Belgium) will be used for~     motor learning.~   "
96133|NCT02308839|"~     This is a French Registry mandated by the French National Health Authority assessing~     long-term (5-years) safety of the GORE® Excluder® Endoprosthesis in the treatment of~     infra-renal Abdominal Aortic Aneurysms (AAA).~   "
96134|NCT02308826|"~     This project is intended to provide a rigorous test of the Turtle Program, an early~     intervention program for behaviorally inhibited preschoolers. The proposed project will~     extend promising pilot study findings by: (a) evaluating the integrated intervention in a~     larger sample (n = 150) of 45-64 month children and their parents, which will allow for an~     examination of mediators and moderators of treatment effects; (b) comparing the Turtle~     Program to the best available treatment for preschool behavioral inhibition, the Cool Little~     Kids (CLK) parent psychoeducation group; (c) examining heart rate reactivity and regulation~     as both baseline moderators of treatment response and as outcome measures; (d) examining~     parent anxiety disorders as a moderator of treatment response; (e) including a mid-treatment~     assessment and extending follow-up to one year.~   "
96135|NCT02308813|"~     Several studies exist on patient performance in drive simulators especially around and after~     surgery. Recommendations concerning the ability to drive preoperatively are based on these~     studies, which generated their data using drive simulators. However, in all the datasets~     driving performance remains highly individual. Since a drive simulator is not readily~     available in normal general practitioner surgeries it would be helpful to have convenient~     clinical tests to evaluate a patients individual ability to perform an emergency stop. This~     study aims at evaluating different possibilities how such performance might be predicted.~     Patients with hip osteoarthritis and patients who have received total hip arthroplasty are~     tested clinically and their results are compared with the gold standard experiment - a drive~     simulator.~   "
96136|NCT02308800|"~     The investigators plan a randomized clinical trial of 150 patients with infected~     diabetes-related lower extremity wounds to compare the clinical and economic effectiveness of~     negative pressure wound therapy with continuous irrigation and negative pressure wound~     therapy without irrigation.~      The investigators will enroll 150 patients from two centers: The University of Texas~     Southwestern University Hospital and Parkland Hospital. The investigators will screen and~     enroll patients with wounds in the inpatient setting. Patients will randomized to receive~     traditional NPWT or NPWT with continuous irrigation while they are hospitalized. The average~     hospitalization for patents that receive NPWT is 13.3 days. Patients that do not have their~     wound surgically closed during hospitalization will be discharged with negative pressure~     wound therapy without irrigation for up to a total of four weeks of therapy. After discharge~     from the hospital, subjects will be seen twice weekly by home health, and the investigators~     will evaluate subjects in clinic every 7 days (±7 days) for a total of 16-week period or~     until the wound heals.~   "
96137|NCT02308787|"~     Multicenter, Retrospective Data Collection of Routine Clinical Use with the Spectra Optia®~     Apheresis System for Platelet Depletion Procedures.~   "
96138|NCT02308774|"~     We plan a cohort study of 40 diabetic patients admitted to Parkland hospital with a foot~     infection. We will enroll a representative cross section of subjects with diabetic foot~     infection. Patient will be consented and will receive therapy based on standard protocols.~     Currently patients with suspected osteomyelitis have bone biopsies to identify bacterial~     pathogens and verify MRI diagnosis. Repeat bone biopsies are performed at the end of therapy~     to verify that osteomyelitis has been successfully treated. Serum to measure procalcitonin~     will be obtained at baseline, week 3 and week 6.~   "
96139|NCT02308761|"~     RO6870810 (formerly TEN-010) is a small molecule, bromodomain and extra-terminal (BET)~     bromodomain inhibitor. This study is designed to characterize the safety, tolerability, and~     pharmacokinetics of RO6870810 monotherapy in participants with relapsed/refractory acute~     myeloid leukemia (RR-AML) and hypomethylating agent (HMA)-refractory myelodysplastic syndrome~     (MDS). The study will consist of a Screening Period, Treatment Period, and Post-Treatment~     Period. A standard 3+3 design will be used in which successive cohorts of three or more~     participants with RR-AML or HMA-refractory MDS will be treated at escalating doses until a~     maximum tolerated dose (MTD) is identiﬁed. Up to 51 adult participants with AML or MDS will~     be enrolled in the study.~   "
96140|NCT02308748|"~     The primary objective of this research study is to test the hypothesis that late sodium~     current blocking drugs (mexiletine or lidocaine) can attenuate the effect of hERG potassium~     channel blocking drugs (dofetilide) on ventricular repolarization (QTc) by shortening early~     repolarization (J-Tpeakc). The secondary object is to assess the ability of calcium channel~     block (diltiazem) to reduce the QTc prolongation associated with hERG block (moxifloxacin).~   "
96141|NCT02308735|"~     Gestational diabetes mellitus (GDM) affects as many as 14% of women in the United States.~     Furthermore, the number of pregnant women with pregestational diabetes mellitus (PGDM) is~     also increasing, mainly due to an increase in the diagnosis of non-insulin dependent diabetes~     mellitus. A recent study demonstrated that 1.3% of pregnancies are now complicated by PGDM~     and that PGDM now comprises 21% of the diabetes that complicate gestations, which represents~     a two fold increase since 1999. One notable side effect of diabetes is an elevation of~     endogenous ethanol production, which in turn may result in a rise in fetal production of~     fatty acid ethyl ester (FAEE). FAEE found in meconium have been utilized as a marker of~     prenatal ethanol exposure. Therefore, FAEE elevation could call into question maternal claims~     of abstinence from alcohol during pregnancy. This study seeks to determine if meconium FAEE~     levels in the newborns of abstinent women with various classifications of diabetes mellitus~     are increased when compared to non-diabetic, abstaining controls.~   "
96142|NCT02308722|"~     In this study the investigators are testing if the addition of Stereotactic Body Radiation~     therapy (SBRT) prior to surgery improves surgical outcome in patients with borderline~     resectable or resectable pancreatic cancer (BRPC).~   "
96143|NCT02308709|"~     The primary objective of this study is to assess the safety and feasibility of personalized~     radiotherapy with four-dimensional (4D) computed tomography (CT)-based pulmonary ventilation~     imaging, which selectively avoids irradiating highly-functional lung regions.~   "
96144|NCT02308696|"~     The investigators' overall objective is to evaluate the effectiveness of peer-to-peer support~     programs in preventing the necessity of acute health care and nursing home services for older~     adult populations and in promoting their health and wellness. The investigators' Specific~     Aims are:~        1. To compare the effectiveness of peer-to-peer community support in preventing~          hospitalization, emergency department (ED) use, and nursing home placement in an at-risk~          older adult population relative to standard community services.~        2. To compare the effect of peer-to-peer community support on intermediary measures of~          health and wellness such as self-rated health, depression, and anxiety relative to~          standard community services.~   "
96145|NCT02308683|"~     Current evidence supports a central role of inflammation in the pathogenesis of~     atherosclerosis and diabetes [57-60]. Diabetes Mellitus type 2 is an inflammatory~     atherothrombotic condition associated with high prevalence of thrombotic cardiovascular~     disease. In patient with DM type 2, this inflammation is reflected by elevated plasma levels~     of several biomarkers of inflammation such as C-reactive protein (CRP) [51-55]. HsCRP is~     considered as a strong predictive of cardiovascular risks and death [53, 61-72]. Besides its~     predictive role in determining cardiovascular risk, there is some evidence that CRP may~     represent an active participant in atherogenesis [54]. CRP is expressed in human~     atherosclerotic plaques and both vascular cells and monocytes/macrophages appear to represent~     a significant source of CRP in the inflammatory vessel wall [54].~      Among the DM risk factors (like hypertension, atherogenic dyslipidemia, insulin resistance,~     impaired fibrinolysis, inflammatory profile), definitely, inflammation is the neglected one.~      Moringa oleifera has been suggested to exert anti-inflammatory effects [42][43][45] and~     hypoglycemic property [80]. As with many reports of the nutritional or medicinal value of a~     natural product, there are an alarming number of purveyors of healthful food who are now~     promoting M. oleifera as a panacea. While much of this recent enthusiasm indeed appears to be~     justified, it is critical to separate scientific evidence from anecdote.~      Herein, the investigators will investigate the effects of Moringa oleifera leaves~     supplementation on levels of inflammatory marker specifically hsCRP, hgbA1c level and~     clinical outocome in diabetic patients through a cohort study.~   "
96146|NCT02308670|"~     The primary aim of this study is to observe any changes in MRI in MS patients who have~     switched from 20mg injections/day to 3 40mg injections/week of glatiramer acetate.~   "
96147|NCT02308657|"~     The purpose of the study is to determine the best ways to assess how people are affected by~     myotonic dystrophy type 1 (DM1). The study will assess walking speed, muscle strength, muscle~     size, myotonia, heart rhythm, mental efficiency, and overall health. Participants will~     complete questionnaires to record their ideas about how they are affected by DM1. The study~     will evaluate people with DM1 over 1 year to determine how the condition changes over time.~     The study will identify biomarkers of DM1. Biomarkers are laboratory measurements that show~     the effects of DM1 on a person's muscle tissue or blood. Biomarkers are needed in future~     studies to determine how DM1 may respond to treatments.~   "
96148|NCT02308644|"~     To evaluate the effects on contrast sensitivity (CS) measurements of intravitreal bevacizumab~     injections associated with standard metabolic control in eyes with diabetic macular edema~     (DME) associated with standard metabolic control.~   "
96149|NCT02308631|"~     Indications for colostomy are rectal or anal cancer, diverticular disease, radiation~     enteritis, complex perirectal fistulas, anorectal trauma, severe incontinence, motility and~     functional disorders. It is frequently required in critically ill patients who may not be~     able to tolerate a laparotomy. Laparoscopic-assisted colostomy is an alternative method for~     colostomy without laparotomy, but require general anesthesia.~      Additionally, percutaneous anterior colopexy under colonocopic control offers the possibility~     for improved and faster fixation of the anterior colonic wall to the anterior abdominal wall.~      The objective of this study is to evaluate the feasibility of performing fecal diversion with~     the help of a colonoscope and colopexy, without the additional morbidity of abdominal~     exploration.~   "
96150|NCT02308618|"~     The purpose of this study is to evaluate the effects of early mobilization versus traditional~     immobilization rehabilitation programs after surgical Achilles tendon repair on the~     mechanical (torque-angle and torque-velocity relationships) and electrical (neuromuscular~     activation) properties of the plantar- and dorsiflexor muscles, gastrocnemius medialis~     morphology (muscle architecture), functional performance, and the mechanical and material~     properties (force-elongation and stress-strain relationships) of the injured and uninjured~     Achilles tendon.~      The hypothesis is that the early mobilization could reduce the deleterious effects of the~     joint immobilization and improve the tendon healing.~   "
96151|NCT02308605|"~     The hypothesis is that a stroke causes release of purines from brain into blood and that this~     is a very early biomarker of brain ischaemia. The investigators propose a simple blood test~     of substances (the purines) that result from cellular metabolism and are produced in excess~     when brain cells are starved of oxygen and glucose (as occurs during a stroke).~   "
96152|NCT02308592|"~     The purpose of this pilot study is to examine the feasibility of conducting a multi-site~     randomized controlled trial whose aim will be to evaluate the effectiveness of a Patient~     Decision Aid (PDA) for antidepressant use in pregnancy.~   "
96153|NCT02308579|"~     This a retrospective, blinded trial in which collaborators in Italy will review the doppler~     findings from the Combined Transcranial and Extracranial Venous Doppler (CTEVD) trial in an~     attempt to measure reproducibility.~   "
96154|NCT02308566|"~     In this study, the investigators aim to compare cerebral embolic load in patients undergoing~     surgical aortic valve replacement using either the minimized extracorporeal circulation or~     the conventional extracorporeal circulation technique. The detection of cerebral emboli is~     performed not-invasively by transcranial Doppler detection of high-intensity transient~     signals representing solid or gaseous microembolism in the middle cerebral arteries. The~     investigators hope to get more insight in the mechanism (incl. quantity) of cerebral embolism~     during aortic valve surgery using extracorporeal circulation.~   "
96155|NCT02308553|"~     This is a multicenter, randomized, double-blind, placebo-controlled phase I/II trial designed~     to characterize the safety and estimate the efficacy of nintedanib when combined with~     paclitaxel chemotherapy compared with paclitaxel chemotherapy alone in patients with BRAF~     wild type metastatic melanoma not previously treated with taxanes or kinase inhibitors.~   "
96156|NCT02308540|"~     Phase 1/2, Prospective, Single Center, Randomized, ActiveControlled, Double-Blind, Age~     De-escalation Study to assess the safety and tolerability of SIILPCV10 administered as a~     single-dose regimen to healthy Gambian pneumococcal conjugate vaccine (PCV)-naïve young~     adults and PCV-primed toddlers through 4 weeks post vaccination.~      Each adult and toddler subject will undergo a total of 4 clinic visits. Each infant subject~     will undergo a total of 9 scheduled visits. Blood will be collected from all subjects during~     the screening visit for safety and potential immunological assessments, and 28 days after~     completion of the vaccination schedule for immunological assessments. For adults, the vaccine~     will be given IM into the mid-deltoid muscle of nondominant arm using a 24-gauge needle. For~     toddlers and infants, the vaccine will be given IM into the anterolateral aspect of the left~     thigh. Blood will be collected from adults and toddlers for safety labs at the Day 7~     post-vaccination visit.~   "
96157|NCT02308527|"~     The purpose of this study is to investigate whether Bevacizumab (an anti-VEGF monoclonal~     antibody) added to a backbone chemotherapy regimen (Temozolomide, Irinotecan-Temozolomide or~     Topotecan-Temozolomide) demonstrates activity in children with relapsed or refractory~     neuroblastoma. Also, to investigate whether the addition of Irinotecan or Topotecan to~     Temozolomide increases the activity of chemotherapy.The primary objective of the study is the~     best response (Complete Response or Partial Response) while trial treatment, within 18 or 24~     weeks depending on the arm of the trial the participant is randomised to. Secondary endpoints~     are assessing the side effects, the length of time before progression (Progression Free~     Survival) and overall survival (OS).~      This trial will address two important questions:~        -  does targeting blood vessel development using bevacizumab, (a monoclonal antibody~          against the Vascular Endothelial Growth Factor (VEGF)), add to the effect on a tumour~          when used with existing chemotherapy, compared to the effect of the existing~          chemotherapy alone (temozolomide)?~        -  does the addition of a second chemotherapy drug (irinotecan or topotecan) increase the~          effect on a tumour compared to the effect of one alone (temozolomide) Patients aged 1-21~          years of age with relapsed or refractory high-risk neuroblastoma are randomised to one~          of six treatment arms: Temozolomide (T), irinotecan-temozolomide (IT), bevacizumab-T~          (BT), BIT (bevacizumab-IT), temozolomide-topotecan (TTo) or~          bevacizumab-temozolomide-topotecan (BTTo).~   "
96158|NCT02308514|"~     In this study the investigators want to measure the impact or effects of adding~     cryostimulation to the conservative care of chronic lateral epicondylitis. The rapid fall in~     skin temperature above the injured tissues is presume to have a positive effect in the~     healing process. The combination of conservative care and cryostimulation could then be~     appreciated. The investigators chose to measure these effects with 3 elements: visual analog~     pain scale, validated elbow questionnaire and pain free grip strength. This pilot study~     consist in a two arm design, each arm including 15 patients.~   "
96159|NCT02308501|"~     A Single-Center Evaluation of the Anti-Inflammatory Effects of Lastacaft ® as Measured by~     In-Vivo Confocal Microscopy~   "
96160|NCT02308488|"~     Following consent, patients will receive 15 fractions of radiotherapy to the affected breast~     and to Axillary level III and SCV (Supra-Clavicular) lymph nodes, defined by CT imaging~     obtained in a prone position using IMRT(intensity modulation radiation therapy ) technique:~     one fraction daily for 5 days/week for 3 consecutive weeks. Patients will be seen for~     follow-up at 45-60 days from first radiotherapy treatment, and then yearly. Patients will be~     assessed for Lymphedema at baseline, end of treatment, and at yearly intervals after~     completion of radiotherapy. All patients will be followed for toxicity and outcome (local and~     systemic recurrence, survival). In addition, patients will complete a self-assessment of QOL~     at baseline, week 3, day 45-60 and 2-yr follow-ups.~   "
96161|NCT02308475|"~     To assess the ability of a novel 3rd generation dual-source CT system to demonstrate~     myocardial perfusion in a cohort of patients presenting to the Chest Pain Center with acute~     chest pain.~   "
96162|NCT02308462|"~     In order to identify psychological stress in children and adolescents of mentally ill parents~     as early as possible, a special intervention program (CHIMPs = Children of mentally ill~     parents) was developed. The study at hand will implement this intervention program at five~     sites in Germany and will further evaluate its effectiveness. The CHIMPs intervention is~     assumed to reduce children's psychopathology and enhance their health related quality of~     life.~   "
96163|NCT02308449|"~     Iron deficiency is common in cardiorespiratory diseases and appears to contribute to a worse~     outcome. This human physiology study will examine the extent to which human skeletal muscle~     metabolism and exercise physiology are impaired by iron deficiency.~   "
96164|NCT02308436|"~     In vitro results showed a protective effect against acids for the mouthwash containing~     Curolox™ peptide. The goal of this in situ study is to detect the Curolox™ peptide under~     natural oral conditions on the tooth surface and to proof the in vitro results obtained. So~     far there are no effect and safety data of the Curolox™ mouthwash under natural oral~     conditions available.~   "
96165|NCT02308423|"~     in this study the investigators will call patients who had Subchondral fractures and treated~     in our department over the last 20 years.~      The investigators will evaluate their shoulder function by a questionary, Constant score and~     radiologic evaluation.~   "
96166|NCT02308410|"~     A pneumatic tourniquet is often used during total knee arthroplasty. However, its effect on~     postoperative outcomes as soft tissue damage resulting in delayed recovery remains unclear.~     The purpose of the present study was to compare tourniquet use versus non-tourniquet use~     during total knee arthroplasty for short-term functional recovery.~   "
96167|NCT02308397|"~     The aim of the study is to produce a tolerable alternative to normal wheat bread which would~     be suitable for subjects with self-reported non-coeliac gluten sensitivity (NCGS). The bread~     would be made from wheat so, in contrast to gluten-free bread, would be more comparable to~     standard bread. To make this bread, the investigators will use advanced enzyme technology~     and/or novel formulations to target the digestion or removal of wheat proteins, which might~     be involved in the etiology of non-coeliac gluten sensitivity, preferentially over other~     those that are more useful for baking quality. The investigators will determine palatability~     and tolerance of this new product in a human cross-over, randomised, blind and~     placebo-controlled intervention study.~      It has been estimated 6-10% of the population are sensitive to gluten who do not have coeliac~     disease (CD). Three breads will be produced and tested in this study against a suitable~     reference based on standard wheat flour and baking process~   "
96168|NCT02308384|"~     Background~      Colorectal cancer (CRC) is common, and a leading cause of cancer death. The evaluation of~     patients suspected to have CRC is difficult due to poorly predictive alarm symptoms and many~     patients present with uncharacteristic or vague symptoms. The faecal marker of human globin,~     iFOBT, could play an important role in aiding the general practitioner in detecting CRC.~      Hypothesis~      It will be possible to implement iFOBT in general practice as a test performed on patients~     who do not fulfill the criteria for fast-track referral for colorectal cancer, but whose~     symptoms could indicate an undiagnosed colorectal cancer.~      Aim~      To implement iFOBT in general practice and evaluate the uptake and clinical use of the test.~     Furthermore, we want to investigate the performance of iFOBT when used on patients presenting~     with uncharacteristic symptoms of CRC, and the clinical implications.~      Materials and methods~      The study uses a cluster randomised stepped wedge design. Clusters are constituted by the 18~     municipalities in the central Denmark Region, and these are randomised when to receive a~     continuous medical education (CME). The date of inclusion is defined as the first working day~     in the month the CME is planned to be conducted. The CME is part of an intervention aimed to~     facilitate the implementation of iFOBT in general practice. Besides a CME, the intervention~     consist of a start package (iFOBT kits, a guideline and online educational material) that is~     sent to GPs when they are included in the study, and a status mail that GPs receive approx.~     one month after inclusion. The inclusion period is during the first 7 month of the study~     period, the study lasts for one year.~      Perspectives~      This study will provide important knowledge on how to improve CRC diagnostics in general~     practice.~   "
96169|NCT02308371|"~     Children who are critically ill often require large amounts of fluid during their acute~     illness. It has been shown in multiple studies that appropriate administration of fluid~     decreases morbidity and mortality, but giving too much fluid can also cause increased~     morbidity and mortality. It is often difficult to discern from physical exam, vital signs and~     labs if the amount of fluid that has been given is appropriate or if a pediatric patient~     requires more fluid. Pulse pressure variation (PPV) is the change in blood pressure when a~     patient is on a ventilator or breathing machine. PPV has been used in multiple adult studies~     to help predict fluid needs in a critically ill patient. In this study, we would like to~     investigate if PPV can help better predict if critically ill pediatric patients in the~     pediatric intensive care unit (PICU) need fluid. The investigators hope that by having the~     additional information that PPV can provide, physicians can more judiciously give fluid and~     thereby improve morbidity of critically ill patients in the PICU.~   "
96170|NCT02308358|"~     The purpose of this study is to evaluate the functional and clinical outcomes of patients~     receiving femoral condyle osteochondral allografts, to evaluate potential predisposing~     factors to failure of such grafts, and to compare the overall outcomes of the grafts to the~     current standard of care for smaller lesions, microfracture. Our hypothesis is that patients~     treated with these allografts will demonstrate significant functional improvement as measured~     by validated outcome scoring measures and their function will be at least equal to that of~     microfracture outcomes.~   "
96171|NCT02308345|"~     Cancer patients about to begin chemotherapy receive large amounts of information regarding~     their prognosis, how chemotherapy improves their prognosis, and the usual side effects of the~     chemotherapy during their first visit to the oncologist. Prior studies have documented that~     less than half of this information is retained after the visit, making it difficult for~     patients to participate in their care and difficult for them to enlist the help of their~     social support. The MiVideo project allows the physician to create a custom 5-minute summary~     video summary of a pre-chemotherapy clinic visit and upload it to a secure web site. The~     video will emphasize the major points of the forty-five minute office discussion, allowing~     patients to review the physicians' recommendations and share the information and~     recommendations with others. By providing the patient with this re-cap of their visit, the~     investigators hope to engage them more actively in their cancer treatment. Making the~     information available to friends and family can also help a patient receive both intellectual~     and emotional support during the course of treatment. The primary endpoint of this study is~     improvement of patient care, not research activity.~      Primary Hypothesis: Creating a 5-minute video summarizing information about diagnosis, stage,~     chemotherapy treatment plan, and anticipated side effects for patients starting chemotherapy~     for colon cancer will not significantly lengthen the pre-chemotherapy clinic visit as~     compared to visits that do not include video production.~   "
96172|NCT02308332|"~     This study will evaluate the effects of switching Atripla to Eviplera on neurocognition~     measured by neuropsychological testing and functional MRI~   "
96173|NCT02308319|"~     Antiviral therapy for HBV may play an important role here, as a large observation study from~     Taiwan reported that the use of nucleos(t)ide analogues (NUC) was associated with 33%~     reduction in HCC recurrence. In the first randomized controlled trial evaluating the use of~     NUC after surgical resection for HCC, NUC therapy was associated with better 2-year overall~     (94% vs. 62%) and recurrence-free (56% vs. 20%) survival. However, patients with active liver~     disease should be treated regardless of their impact on HCC recurrence (patients with high~     serum HBV DNA and abnormal ALT). What is less clear is that whether patients with low level~     HBV DNA, and normal serum ALT levels should be treated to reduce HCC recurrence.~      In this trial, we will investigate to determine the efficacy of the treatment with Tenofovir~     disoproxil fumarate (Viread(R)) as measured by the cumulative incidence rate of~     hepatocellular carcinoma (HCC) at 3 year after curative treatment with radiofrequency~     ablation (RFA) or surgical resection (SR) in chronic hepatitis B virus (HBV) infected~     patients with low viral load.~   "
96182|NCT02308202|"~     The aims of this study is to determine the effects of treatment with doxazosin XL 16 mg/d~     combined with virtual reality (VR) exposure therapy on Post Traumatic Stress Disorder.~      The effects of treatment with doxazosin XL 16 mg/d combined with virtual reality (VR)~     exposure therapy will be assessed in double-blind, placebo-controlled study. The study will~     enroll 30 participants. The investigators will use a within groups design in which all~     participants receive both placebo and doxazosin (N=16) with the order counterbalanced across~     participants. A second group of patients (N=16) will receive both 16mg perindopril and~     placebo instead of doxazosin/placebo.~   "
96183|NCT02308189|"~     A pilot randomized control trial (RCT) to generate effect sizes on the effects of blood flow~     restricted exercise on trunk extensor cross-sectional area (primary outcome), strength and~     endurance, whole body and regional lean mass and bone density, as well as the rate of~     recurrence of LBP (secondary outcomes).~   "
96174|NCT02308306|"~     The overall goal of the ABILITY study is to help improve pain diagnostics and treatment by~     developing an implementable clinical computerised decision support system based on individual~     patient characteristics.~      The investigators hypothesize that successful pain control with opioids can be predicted~     before treatment initiation with advanced data analyses of data originating from~     pre-treatment EEG, QST and pain-related catastrophic thinking.~      The primary objective of this study is the identification of markers that can be used to~     individualize treatment recommendations, i.e. to reliably predict the response of pain to~     opioids.~      Markers are selected among the most promising data and machine-learning methods are used for~     the prediction. This includes determining the associations between a battery of selected~     pre-treatment clinical predictive markers and the analgesic effect of opioid treatment in~     opioid naïve chronic pain patients, including indication and responder identification.~      The key secondary objectives are as follows: to investigate pre-treatment clinical predictive~     markers as predictors of opioid treatment efficacy and effectiveness in terms of the~     following:~        -  Pain intensity and unpleasantness~        -  Use of rescue analgesics~        -  Physical functioning~        -  Global improvement and satisfaction with treatment~   "
96175|NCT02308293|"~     Iatrogenic hypoglycemia is the most frequent acute complication of insulin therapy in people~     with type 1 diabetes (T1DM). Recurrent hypoglycemic events initiate a process of habituation,~     characterized by suppression of hypoglycemic symptoms, eventually leading to hypoglycemia~     unawareness, which creates a particularly high risk of severe hypoglycemia. Recent evidence~     suggest a pivotal role for (brain) lactate in the pathogenesis of hypoglycemia unawareness.~     Indeed, exogenous lactate administration may preserve brain function and attenuate~     counterregulatory responses to and symptomatic awareness of hypoglycemia. It is unknown~     whether endogenous elevation of plasma lactate produces the same effects and whether such~     effects differ between patients with T1DM with and without hypoglycemia unawareness and~     healthy controls.~      Objective: To investigate the effect of elevated levels of endogenous lactate on brain~     lactate accumulation and on counterregulatory responses to, symptomatic awareness of and~     cognitive function during hypoglycemia in patients with T1DM with and without hypoglycemia~     unawareness and normal controls.~      Hypothesis: The investigators hypothesize first that endogenous lactate, when raised through~     high intensity exercise, preserves neuronal metabolism during subsequent hypoglycemia, which~     in turn will attenuate counterregulatory hormone responses, appearance of symptoms and~     deterioration of cognitive function. Second, the investigators posit that these effects will~     be augmented in patients with hypoglycemia unawareness compared to healthy subjects and T1DM~     patients with normal awareness as a consequence of greater transport capacity of lactate into~     the brain.~   "
96176|NCT02308280|"~     Multiple myeloma is a morbid disease associated with a poor outcome, particularly those with~     high-risk cytogenetics. While standard therapies have modestly improved survival in these~     high-risk patients, myeloma remains incurable. To date, the only potential curative treatment~     remains allogeneic hematopoietic stem cell transplantation. However, the high incidences of~     toxicities including chronic GVHD and disease progression are currently the two most~     important obstacles to this therapy. Better approaches to maintain and improve benefits of~     allogeneic transplant, while decreasing toxicity, are urgently needed.~      The investigators hypothesize that Bortezomib administration after non myeloablative~     allogeneic hematopoietic stem cell transplantation in high-risk myeloma patients might~     improved the outcome of these patients by decreasing myeloma relapse and the severity of~     chronic GVHD while preserving the graft-versus-myeloma effect. Our goal is to improve the~     poor clinical outcome of high-risk myeloma patients.~   "
96177|NCT02308267|"~     This project entitled Impaired secretory IgA and mucosal immunity in cystic fibrosis is a~     research program which aims to determine, owing to national (KULeuven) and international~     (Descartes university Paris, university of Torino) collaborations for expertise and access to~     human material, whether a defect exists for the production of IgA antibodies in the lung from~     patients with this serious genetic disease. These antibodies line and protect normally the~     airways, and are secreted through a specific epithelial receptor called pIgR (polymeric~     immunoglobulin receptor); its expression and regulation will be studied in lung tissue and in~     cell cultures of the lung epithelium from these patients. The link between the putative IgA~     defect and chronic bacterial infection with Pseudomonas aeruginosa, which often complicates~     the evolution of the disease, will also be evaluated ex vivo and in vivo, in an animal model~     of lung infection.~   "
96178|NCT02308254|"~     The purpose of this study is to determine the effects of the drug lixisenatide on blood sugar~     levels, stomach emptying, blood pressure and heart rate, release of gut hormones and blood~     flow in the gut after a glucose drink in both healthy subjects and people with type 2~     diabetes. If lixisenatide is shown to be effective, it would encourage ongoing evaluation of~     its potential use in the management of the falls in blood pressure following a meal in~     diabetic patients.~   "
96179|NCT02308241|"~     The purpose of this study is to find out the effects, both good and bad, that a drug called~     ribavirin has on the patient and the cancer.~      Ribavirin has also been studied in clinical trials for patients with various types of cancer.~     These studies demonstrated that ribavirin can be safely given at higher doses than the dosing~     that is used as part of the treatment of hepatitis C.~      Ribavirin is known to target a protein called 4E that turns on a central part which causes~     the cell to grow, called the ribosome. HPV-related cancers often have abnormally high levels~     of 4E. The purpose of this study is to evaluate if ribavirin may be a useful treatment for~     patients with advanced cancers that are related to HPV by blocking the activity of 4E.~   "
96180|NCT02308228|"~     The purpose of this study is to determine whether a commonly prescribed drug, metformin, can~     enhance the benefits seen during resistance exercise such as increased muscle mass and~     strength.~   "
96181|NCT02308215|"~     The main purpose is to find a better way to predict the timing of treatments given to~     patients with Wet Age-related macular degeneration using image analysis.~   "
96199|NCT02307981|"~     Patients who suffer an ischemic stroke in the occipital lobe often experience Visual Field~     defects. Visual Field defects are negatively correlated to falling, institutionalisation,~     rehabilitation outcome and quality of life. Patients are often not properly examined and~     seldom receive rehabilitation. NOR-OCCIP aims to evaluate the Natural history of Visual Field~     defects after occipital infarction and to determine whether rehabilitation is effective.~   "
96184|NCT02308176|"~     INTRODUCTION: Obesity is the most common metabolic problem and its genesis and maintenance~     there is always a positive energy balance, with less energy expenditure than that obtained~     from the intake. Low physical activity is often an important factor in this lower spending.~     Medical advice is useful for determining changes in the habits of life of patients, however,~     the changes produced by the council do not last over time, so it would be necessary to~     establish enforcement mechanisms as with mobile technology, because it could improve the~     adhesion of obese patients to therapy. OBJECTIVE: Primary: To evaluate the effectiveness of~     an app as an adjunct to medical advice to promote healthy living habits (sport and diet) to~     lose weight in a population of obese or overweight adult patients. MATERIAL AND METHODS: Open~     randomized controlled clinical trial with clinical practice (health advice for physical~     activity and sport). STUDY POPULATION: Obese or overweight adults patients of Araba aged~     between 18-45 years who be in Contemplation stage with smartphone. Variables: Primary~     endpoint: Weight (kg); Secondary variables: BMI (kg/cm2); blood pressure (mm Hg); heart rate;~     Plasma cholesterol (mg / dl); HbA1c; score on the satisfaction questionnaire; index of~     physical exercise (IPAQ) (METs); quitting tobacco (yes / no); Waist circumference (cm).~     Statistical analysis: The primary endpoint (weight reduction) will be evaluated by covariance~     analysis adjusting by baseline weight, and other confounding variables (sex, age, level of~     education..) Simple size: 48 patients by arm plus 20% to cover losses to follow.~   "
96185|NCT02308163|"~     The objective of this study is to verify the superiority of ASP015K alone or in combination~     with disease-modifying antirheumatic drugs (DMARDs) over placebo in terms of efficacy in~     patients with rheumatoid arthritis (RA) who had an inadequate response to DMARDs~   "
96186|NCT02308150|"~     The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve~     replacement (TAVR) in the Asian Pacific population~   "
96187|NCT02308137|"~     The purpose of this clinical trial is to determine if Domperidone in a dose of 40 mg daily~     can prevent worsening of walking ability in people secondary progressive MS. The number of~     participants in this study will be 62. A maximum of 75 people with secondary progressive MS~     will be included. Each patient will be followed for 12 months from inclusion. Domperidone is~     a medication which has been shown to increase levels of the hormone prolactin. The best~     understood function of prolactin is the stimulation of milk production in women after~     delivery. However, the increase in prolactin levels seen in patients treated with standard~     doses of Domperidone (in doses of up to 80mg per day) usually does not lead to clinical~     symptoms. Prolactin has been shown to improve myelin repair in mice. Domperidone therefore~     may also improve myelin repair in people with MS. Domperidone is currently approved in Canada~     to treat slow moving bowels and nausea, for instance in patients with Parkinson's Disease or~     Diabetes Mellitus, where too slowly moving bowels can cause constipation. Domperidone is~     available as a tablet that is usually taken four times per day. Doses up to 80mg per day may~     be used but we estimate that a dose of only 40mg daily will be needed to stimulate myelin~     repair. Domperidone is usually well tolerated.~   "
96188|NCT02308124|"~     Compare the effect of treatment of midodrine and pyridostigmine in neurogenic orthostatic~     hypotension and investigate the quality of life of treatment of neurogenic orthostatic~     hypotension.~   "
96189|NCT02308111|"~     Primary Biliary Cholangitis (PBC) is a serious, life-threatening, bile acid related liver~     disease of unknown cause. Without treatment, it frequently progresses to liver fibrosis and~     eventual cirrhosis requiring liver transplantation or resulting in death. The investigational~     drug, Obeticholic Acid (OCA) is a modified bile acid and FXR agonist that is derived from the~     primary human bile acid chenodeoxycholic acid. The key mechanisms of action of OCA, including~     its choleretic, anti-inflammatory, and anti-fibrotic properties, underlie its~     hepatoprotective effects and result in attenuation of injury and improved liver function in a~     cholestatic liver disease such as PBC. The study will assess the effect of OCA compared to~     placebo, combined with stable standard care, on clinical outcomes in PBC patients.~   "
96190|NCT02308098|"~     The purpose of this study is to confirm equivalent bronchodilator efficacy of the test~     product compared to the reference product.~   "
96191|NCT02308085|"~     The best available evidence suggests that pregnancy after breast cancer does not increase a~     woman's risk of developing a recurrence from her breast cancer. In particular, the most~     recent data suggest that this is the case also in women with a hormone receptor-positive~     breast cancer. There is also no indication of increased risk for delivery complications or~     for the newborn. The aim of the study is to investigate if temporary interruption of~     endocrine therapy, with the goal to permit pregnancy, is associated with a higher risk of~     breast cancer recurrence.The study aims also to evaluate different specific indicators~     related to fertility, pregnancy and breast cancer biology in young women. A~     psycho-oncological companion study on fertility concerns, psychological well-being and~     decisional conflicts will be conducted in interested Centers.~   "
96192|NCT02308072|"~     The phase I trial aims to determine the recommended phase II dose (RP2D) and schedule of~     olaparib in combination with standard cisplatin-based chemoradiotherapy, in patients with~     high-risk locally advanced squamous cell carcinoma of the head and neck (HNSCC), by assessing~     the safety and tolerability of the treatment combination.~   "
96193|NCT02308059|"~     The current study aimed to evaluate the cross-sectional area (CSA) of peripheral nerves in~     people with diabetic peripheral neuropathy using ultrasonography and correlate the CSA with~     clinical and demographic data.~   "
96194|NCT02308046|"~     The purpose of this study is to evaluate the safety and efficacy of terconazole gel in the~     treatment of vaginal infections~   "
96195|NCT02308033|"~     The purpose of this study is to evaluate the safety and efficacy of metronidazole gel in the~     treatment of vaginal infections.~   "
96196|NCT02308020|"~     The main purpose of this study is to evaluate the safety and effectiveness of the study drug~     known as abemaciclib in participants with hormone receptor positive breast cancer, non-small~     cell lung cancer (NSCLC), or melanoma that has spread to the brain.~   "
96197|NCT02308007|"~     The purpose of this study is to evaluate the safety and efficacy of terconazole/metronidazole~     gel in the treatment of vaginal infections~   "
96198|NCT02307994|"~     The purpose of this study is to determine whether uFSH is effective and safe in the treatment~     of male patients with severe oligospermia or azoospermia.~   "
96201|NCT02307955|"~     The device to be tested (fireflyTM) stimulates the common peroneal nerve and causes the foot~     to twitch, and has been shown to increase blood flow. The device is also indicated for the~     treatment of oedema. In this study the investigators intend to assess the use of the device~     as an adjunctive therapy for people recovering from grade 1 and 2 ankle sprains.~   "
96202|NCT02307942|"~     The main objective of this study is to compare the efficacy of two weight losing strategies~     (obesity surgery with gastric banding, and standard of care) on physical performance in~     elderly obese persons submitted to a physical training. Our hypothesis is that a~     surgery-induced weight loss in the context of a physical training (which is recommended in~     people 60-75 yrs losing weight) improves physical performance as compared to standard of care~     (3-5% weight loss).~   "
96203|NCT02307929|"~     In the past two decades, as a result of population aging and shifts in patient needs, we have~     seen an increased demand for chronic disease management (CDM) delivered in the community. The~     Hong Kong Government introduced six nurse allied health clinics (NAHC) programme to assist~     the delivery of care to facilitate the increased demand on chronic disease management (CDM)~     in the community, which are currently being piloted within the government funded general~     outpatient clinics (GOPC) of the Hospital Authority (HA). These programmes are designed to~     enhance CDM in primary care through patient empowerment and use of multi-disciplinary nurse~     and allied health led teams, and aim for secondary prevention and treat-to-target for~     specific health conditions. This model of care has already been established in a number of~     countries, namely United Kingdom, Australia, Canada and United States, where~     multi-disciplinary allied-health clinics, nurse practitioners and nurse-led clinics have~     already been integrated into routine practice in primary care (Thomas, Cullum et al. 2000;~     Laurant, Reeves et al. 2005).~      The six NAHC programmes which have been developed to date address falls prevention (FP),~     continence care (CC), mental wellness (MW), wound care (WC), respiratory disease management~     (respiratory clinic) and medication management and compliance (MMCC). The evaluation on the~     QOC is an essential part of the programme in order to inform future policy. he Department of~     Family Medicine and Primary Care (FMPC) of the University of Hong Kong (HKU) has been~     appointed by the HA to carry out the evaluation of the QOC of the programme.~      The Action Learning and Audit Spiral methodologies to measure whether the target standard of~     care intended by the NAHC programme is achieved. Each NAHC participating clinic will be~     invited to complete a structured evaluation questionnaire. Anonymized data of all patients~     who have enrolled into the NAHC programme for more than 6 months will be included in the~     evaluation on the process and outcomes of care. Data on the process of care will be retrieved~     from the HA medical records.~      In-depth study of NAHC CC programme: In order to compare the outcomes over time between~     subjects who have and who have not participated in the NAHC Continence Care Programme, three~     hundred and sixty control patients who have not been enrolled into the NAHC CC programme will~     be selected for the comparison in the outcomes of care. Subjects will be followed up by~     telephone to evaluate the effect of the programme in quality of life (QOL), patient~     enablement, and global rating of change in health condition at baseline , 12-month and~     24-month after enrollment.~      Main Outcome Measures: The primary outcomes are the proportion of participants who have~     received the planned process of care and have improvement in clinical outcomes.~      Data Analysis: Descriptive statistics on proportions meeting the QOC criteria will be~     calculated. The changes in clinical, service and patient reported outcomes between baseline~     and discharge will assessed by paired sample t-test. The audit cycle will be repeated 4 times~     over a period of 5 years.~      In-depth study of NAHC CC programme: the clinical outcomes between NAHC CC subjects and~     control group will be compared by independent sample t-test or Chi-square test.~      Results: The QOC of the NAHC programme will be determined. Areas of deficiency and possible~     areas for quality enhancement will be identified.~      Conclusion: The results of this study will provide empirical evidence on whether the HA's~     NAHC programmes enhance the QOC of their participating patients. This information will be~     used to guide service planning and policy decision making.~   "
96204|NCT02307916|"~     A Phase II randomized trial will be initiated to evaluate closure of the perforated tympanic~     membrane as the primary measureable outcome. The goal is to determine the safety and efficacy~     of Fibroblast Growth Factor-2 (FGF-2) in the closure of chronic tympanic membrane~     perforations (TMP). If FGF-2 is topically applied for the treatment of chronic TMP in humans,~     it is hypothesized it will be safe, tolerable and effective for use as treatment for tympanic~     membrane perforation. A total of 60 subjects will be recruited.~   "
96205|NCT02307903|"~     Patients with end-stage renal failure (ESRF) have lost the function to excrete urea and~     maintain electrolyte balance, which is lethal unless they are given renal replacement therapy~     (Gibney, Hoste et al. 2008). As one of the initiatives of service improvement, the HA has~     introduced the haemodialysis public-private partnership (HD PPP) programme to shorten the~     waiting time for patients with ESRF needing HD treatment. HD PPP programme is a new service~     provision model that purchases healthcare services from non-Government healthcare~     organizations. The evaluation on the quality of care (QOC) is an essential part of the~     programme in order to inform future policy. The Department of Family Medicine and Primary~     Care of the University of Hong Kong has been appointed by the HA to carry out the evaluation~     of the QOC of the programme.~      The Action Learning and Audit Spiral methodologies to measure whether the target standard of~     care intended by the HD PPP programme is achieved. Each HD PPP participating hospitals and~     centers will be invited to complete a structure evaluation questionnaire. Sixty patients who~     have agreed to join HD PPP and 60 control patients who have refused to take part in HD PPP~     will be included. The participants will be followed up by telephone to evaluate the effect of~     the programme on quality of life (QOL), patient enablement, and global rating of change in~     health condition. Data on the process of care and clinical outcomes of care will be retrieved~     from the HA medical records.~      Main Outcome Measures: The primary outcomes are the proportion of participants who have~     received the planned process of care and adequate haemodialysis (HD) measured by the Kt/V~      Data Analysis: Descriptive statistics on proportions meeting the QOC criteria will be~     calculated. The outcomes of HD PPP subjects will be compared at 6, 12, 24, 36 and 48 months~     by paired sample t-test. The outcomes between HD PPP subjects and control group will be~     compared by independent sample t-test or Chi-square test.~      Results: The QOC of the HD PPP programme will be determined. Areas of deficiency and possible~     areas for quality enhancement will be identified.~      Conclusion: The results of this study will provide empirical evidence on whether the HD PPP~     can achieve equivalent QOC as the usual HA care in order to guide service planning and policy~     decision making for patients with ESRF.~   "
96206|NCT02307890|"~     Donation after cardiac death (DCD) livers are increasingly utilised in liver transplantation~     but concerns exist regarding negative results. Ischemic cholangiopathy (IC) is damage to one~     or more bile ducts probably caused by inadequate blood flow or a failure of biliary~     epithelium to regenerate. It typically presents weeks to months after liver transplantation,~     is often refractory to treatment and can result in a requirement for re-transplantation.~     Although IC is more common following DCD liver transplantation, it is otherwise very~     difficult to predict and the underlying pathogenesis is poorly understood. The aim of this~     study is to correlate microRNA (miRNA) levels and markers of senescence in liver and bile~     duct biopsies taken during liver transplantation with the incidence of IC following liver~     transplantation.~   "
96207|NCT02307877|"~     Rates of brain atrophy for long term users of fingolimod when compared to glatiramer acetate~     have not been examined in patients with relapsing forms of multiple sclerosis (MS). As~     patients on long term therapy typically have little or no overt signs of white matter~     inflammatory activity (T2, gad lesions), brain atrophy measures can provide insight into~     whether there is continued progression of MS in these patients. What remains unknown is~     whether patients on a particular therapy have a slower rate of brain atrophy. This would~     provide convincing evidence that central nervous system tissue injury is further suppressed.~     Such information would be of substantial clinical benefit when deciding between various~     therapies.~      The investigators will estimate the impact of long term use of fingolimod therapy (defined as~     a minimum of two years on therapy) on whole brain atrophy in treated patients with relapsing~     forms of MS as compared to age and gender matched patients on Glatiramer Acetate.~      The investigators secondary goal is to determine the correlation between brain atrophy and~     cognitive performance in treated patients with relapsing forms of MS.~      The investigators will also examine the correlation between the NeuroQualityofLife (NeuroQOL)~     PROs, patient self-reports of disability, clinical assessment of physical disability, work~     productivity, clinical assessments of cognitive functioning with whole brain volume loss for~     patients on long term fingolimod vs. long term glatiramer acetate therapy matched on age and~     gender.~      The investigators anticipate the findings of this study will generate relevant hypotheses~     about these relationships.~   "
96208|NCT02307864|"~     The purpose of this study is to assess the effects of multiple doses of an immediate release~     (IR) formulation of tramadol hydrochloride (HCl) at therapeutic and supratherapeutic levels~     in healthy adult participants on the electrocardiogram (ECG) QT interval corrected for heart~     rate (QTc).~   "
96209|NCT02307851|"~     The purpose of this study is to determine the immune response of three dose levels of the~     Quadrivalent VLP vaccine in healthy young (18-49) adults. The study is broken down into four~     treatment groups. Each group will enroll 100 subjects, for a total of 400 subjects. Groups~     A-C will receive one of three dose levels of the Quadrivalent VLP vaccine, and Group D will~     receive a commercially available trivalent influenza vaccine (TIV). The study will also~     evaluate the safety and tolerability of the Quadrivalent VLP vaccine formulations.~   "
96210|NCT02307838|"~     This study collected follow-up data on approximately 90% of participants who were randomized~     and received one dose of study drug in FTY720D2201 (D2201). No study drug was given or~     required. Participants were required to be assessed at one or two visits, preferably at the~     original study site, but the option to be interviewed via phone or seen at home was provided.~     Information was gathered also on deceased participants. Assessments were performed only once~     within an 8 week period and included medical history, Multiple Sclerosis (MS) and Multiple~     Sclerosis Disease Modifying Therapy (MS DMT) history, Expanded Disability Status Scale~     (EDSS), Magnetic Resonance Imaging (MRI), and Multiple Sclerosis Functional Composite (MSFC).~   "
96211|NCT02307825|"~     Justification: Chronic rhinosinusitis (CRS) is one of the most common inflammatory diseases~     with an incidence and prevalence superior to 10%. Unfortunately, more than 30% of patients do~     not respond to standard medical and surgical treatment, thus continuously increasing the~     symptomatologic and socio-economic burden of this disease.~      Hypothesis: The investigators believe that the addition of azithromycin (AZI) to the~     treatment regimen of patients with refractory CRS failing conventional medico-surgical~     treatment will be beneficial in a symptomatologic and endoscopic level.~      Primary objective: 1- To evaluate whether Azithromycine 250 mg PO three times weekly is~     effective in controlling signs and symptoms of CRS in high-risk patients unresponsive to~     standard management after endoscopic sinus surgery (ESS) with budesonide irrigations.~      Secondary objectives:~      i) Validate a simple and concise treatment algorithm for patients refractory to standard CRS~     treatment of ESS and BUDI, with the addition of low-dose AZI.~      ii) Characterise and define the population deemed high-risk for standard CRS treatment~     failure by evaluating: 1) demographics, 2) inflammatory states and 3) the nasal flora~     microbiome of patients at the different follow-up points of this study.~      iii) Explore the mechanisms of AZI by assessing the changes in inflammatory states and the~     nasal flora microbiome associated with successful AZI therapy.~      Methods: Inclusion of all patients admitted for endoscopic sinus surgery (ESS) for CRS~     operated by the same surgeon (MD). Following their first postoperative visit (2 weeks), all~     patients will receive nasal irrigations with budesonide (BUDI) twice daily for 4 months and~     will be re-evaluated. If there is a failure of treatment, patients eligible to receive AZI~     will be randomized in to two groups, AZI 250mg or a placebo three times a week for 4 months.~     At every follow-up, complete endoscopic exams will be performed, along with sinus cultures~     and brush cytology.~      Population: All patients deemed high-risk with CRS admitted for ESS between October 2014~     and October 2015.~   "
96212|NCT02307812|"~     The treating physician/investigator contacts Lilly when, based on their medical opinion, a~     patient meets the criteria for inclusion in the ATU.~   "
96213|NCT02307799|"~     The aim of the RESPECT study is to gain a better understanding of the prevalence,~     pathogenesis and symptoms of early chronic obstructive pulmonary disease (COPD). This study~     seeks to address the following specific objectives/research questions: 1) to estimate the~     prevalence of airflow limitation (AL) and COPD in adults 35-70 years of age in St.Petersburg~     and Arkhangelsk based on sex, age, environmental conditions, socioeconomic status and smoking~     status; 2) to compare the prevalence of COPD in the study population based on the Global~     Strategy for Diagnosis, Management and Prevention of COPD (GOLD) and lower limit of normal~     (LLN) criteria; 3) to identify the diagnostic value of various signs, symptoms and background~     characteristics for the diagnosis of COPD; 4) to determine whether differences in background~     characteristics and inflammatory biomarkers are evident between smokers with and without~     COPD; and 5) to describe co-morbidity, functionality and global health status in a cohort of~     newly diagnosed COPD patients.~   "
96214|NCT02307786|"~     Beta thalassemia (β-thalassemia) is the most common genetic disease worldwide. Individuals~     with thalassemia are born with a defect in hemoglobin. Hemoglobin is a protein in red blood~     cells that carries oxygen to vital organs such as the brain, heart, lungs and kidneys.~     Thalassemia major is a hereditary anemia characterized by little or no ß-globin production,~     which results in hemolysis (breakdown or destruction of red blood cells) due to the formation~     of unstable alpha-globin tetramers and ineffective erythropoiesis which is uniformly fatal in~     the absence of regular transfusions. Although improvements in conservative treatment have~     improved the prognosis of thalassemia considerably disease and transfusion related~     complications in affected patients progress over time, causing severe morbidity and shortened~     life expectancy. Substantial lifelong health care expenses are also involved, often a~     financial burden for families and unsustainable in most developing countries.~      The hypothesis is that patients who had beta thalassemia who have undergone a hematopoietic~     stem cell transplant (HSCT) and are >1 year post-HSCT will have less long term comorbidities~     and a higher quality of life (QOL) as compared to those with beta thalassemia who are~     maintained on supportive care. In order to assess quality of life, a quality of life~     questionnaire will be asked. Extraction of data from the patient's medical record will also~     be used to determine any comorbidities that have occurred after either a HSCT or supportive~     care therapy.~   "
96215|NCT02307773|"~     The investigators tested whether a new method which additional lidocaine spray on the tip of~     endoscope can increase the tolerance of examinee during endoscopy than conventional~     pharyngeal anesthesia alone.~   "
96216|NCT02307760|"~     The purpose of this study is to assess growth of preterm infants fed human milk supplemented~     with one of two commercially available human milk fortifiers.~   "
96217|NCT02307747|"~     Circadian rhythms, which play crucial roles in physiology, are emerging as important~     regulators of specific immune functions. Hospitalization in intensive care unit leads to a~     deep impairment of circadian rhythm. Infection is a frequent event during ICU~     hospitalization.~      The investigators hypothesis is that in trauma patients the lack of circadian rhythm~     variations is associated with the occurrence of infection. The primary aim of the study is to~     assess the circadian variations of plasma Bmal1 in the occurrence of healthcare related~     infection during the 30 days after inclusion. The secondary aims are to assess the plasma~     expression of circadian genes (Clock, Cry1, Per3, and Rev-erba), the production of cytokines~     in plasma, and the concentration of cortisol, according to the occurrence of an infection.~   "
96218|NCT02307734|"~     This project proposes two aims. The first aim is to evaluate the efficacy of a family-focused~     intervention in promoting smoking cessation in Chinese and Vietnamese male smokers using a~     2-arm cluster randomized controlled trial with assessments at baseline, 6, and 12 months~     targeting 360 smoker-family dyads. Half of the participants will be assigned to the proposed~     intervention, and the remaining half will be assigned to an attention-control condition where~     they will receive education on healthy eating and physical activity. The second aim is to~     explore mediators to identify key psychosocial and behavioral processes that underlie how the~     intervention affects the processes of quitting and maintaining abstinence in Chinese and~     Vietnamese smokers.~   "
96219|NCT02307721|"~     Overdose with potential deadly outcome is a serious problem among opioid abusers, not least~     in Norway. The annual death toll from overdose is about 250, higher than road traffic~     accidents. Those who inject heroin or other opioids are considered to have the highest risk~     for death from overdose. To save lives, immediate treatment with a μ-opioid antidote such as~     naloxone is required. Usually naloxone is injected into a muscle or a blood vessel.~     Administration of naloxone via the nose (intranasal) has been suggested as an alternative for~     use by emergency teams and possibly also bystanders. This is not only an easier way to give~     naloxone, but would also eliminate the risk for needle stick injuries and blood~     contamination. In a series of studies on intranasal naloxone at The Norwegian University of~     Science and Technology, this study explores pharmacokinetics and pharmacodynamics of~     intranasal and intramuscular naloxone in healthy volunteers under the influence of~     remifentanil.~   "
96222|NCT02307682|"~     The purpose of this study is to compare RTH258 ophthalmic solution for intravitreal (IVT)~     injection at two dosage levels to aflibercept solution for IVT injection (2 mg) in subjects~     with untreated active choroidal neovascularization (CNV) secondary to age-related macular~     degeneration (AMD) in the study eye.This study will be conducted in Argentina, Australia,~     Brazil, Canada, Chile, Colombia, Costa Rica, Guatemala, Israel, Japan, Mexico, Panama, Peru,~     New Zealand, and US (including Puerto Rico).~   "
96223|NCT02307669|"~     The investigators hypothesize that aligning adherence with the patient's own clinical course~     achieves better asthma control and identifies risks for future loss of control, compared to~     current best practice. The study has an adherence optimisation phase, week 1-12 followed by a~     medication management phase, week 12 to week 32.~      The investigators will compare two asthma education interventions, standard Guideline~     recommended practice and feedback from the individual's own INCA device, which assess inhaler~     adherence and relates adherence with changes in PEFR and symptom scores over time.~      The aim of the study is to then incorporate adherence into Guideline recommended medication~     changes so that asthma control is improved and medication rationalised at the end of the~     intervention.~      A secondary aim is to assess the long-term effectiveness of this approach on control and~     exacerbations.~   "
96224|NCT02307656|"~     The primary objective is to assess the taste properties of atazanavir (ATV) and cobicistat~     (COBI) alone and in combination as well as oral test formulations containing both ATV and~     COBI.~   "
96225|NCT02307643|"~     The purpose of this study is to evaluate the safety/tolerability and to explore the efficacy~     of MT-1303 in subjects with systemic lupus erythematosus~   "
96226|NCT02307630|"~     The purpose of this study is to find out how an antibody called Hu3F8 travels through the~     body and to tumors. Antibodies, like Hu3F8, are proteins that help attack tumors or fight~     infections. Antibodies can be made by your own body or in a laboratory. The target of an~     antibody is called an antigen; antibodies fit their antigen like a lock fits a key.~   "
96227|NCT02307617|"~     The purpose of this study is to learn if measures of brain chemicals from a brain scan called~     Magnetic Resonance Imaging and Spectroscopy (MRI/MRS) and brain activity (known as cortical~     excitability and inhibition) collected by Transcranial Magnetic Stimulation (TMS) are~     different in adolescents with depression who are in different stages of treatment.~      Researchers are conducting this study to learn more about how the brain works in adolescents~     with depression and without depression (healthy controls). This is important because it may~     identify a biological marker (a measure of how bad an illness is) for depression that could~     one day be used to identify depressed adolescents who would benefit from certain treatments~     (medications for example) or to monitor how well treatments are working.~   "
96228|NCT02307604|"~     The SPECTAbrain protocol describes a structure for screening patients with brain tumors to~     efficiently allocate eligible patients in relevant therapeutic biomarker-driven clinical~     trials. Efficiency is promoted through the creation of a clinical database of brain tumor~     patients and the respective human biological material biobank for molecular characterization.~     The main objectives are to:~        -  Allocate patients to clinical trials according to the clinical characteristics and~          molecular profile of their tumor;~        -  Identify or validate new molecularly defined subgroups of tumors;~        -  Investigate the prevalence of novel biomarkers to plan future clinical trials;~        -  Enable exploratory/future research;~        -  Facilitate establishment of quality-assured and validated tests for Central Nervous~          System (CNS) tumor biomarkers;~   "
96229|NCT02307591|"~     The purpose of this study is to evaluate the efficacy and safety of amiodarone in the~     treatment of patients afflicted with Ebola virus disease.~   "
96230|NCT02307578|"~     The main objective of the Extended Access Program (EAP) is to ensure that subjects~     participating in Study E2007-G000-332 continue to have access to perampanel until the time~     perampanel becomes commercially available in the country in which they reside.~   "
96231|NCT02307565|"~     Following spinal cord injury autonomic regulation of the cardiovascular system is impaired,~     which results in a variety of measurable abnormalities in blood pressure. Evidence of~     causality has been documented in the general medical literature with findings of improved~     cognitive function following acute increases in blood pressure using the anti-hypotensive~     agent Midodrine Hydrochloride (midodrine). Additionally, a recent report documented an~     inverse association between blood pressure and depression suggesting that low blood pressure~     may confer greater risk than high blood pressure. Midodrine is a drug approved by the Food~     and Drug Administration to treat low blood pressure in the general population. Midodrine is~     not approved in the United States to treat low blood pressure in persons with spinal cord~     injury. Therefore, its use in this study is investigational. The first objective is to~     characterize the relationship between blood pressure, cerebral blood flow velocity and~     cognitive function after a single dose of midodrine compared to placebo. Second objective is~     to determine the long-term safety and efficacy of midodrine administration.~   "
96232|NCT02307552|"~     This study is being performed to verify the ability to use minimally invasive transurethral~     ultrasonic imaging technology for the purpose of identifying prostate cancer. Transurethral~     ultrasonic prostate imaging, may in the future, be used for detection and monitoring these~     disease processes to minimize the need for obtaining surgical biopsy specimens. The~     hypothesis is that tissue-density variations, as revealed in diagnostic ultrasonic imaging,~     results in unique image signatures for identification of prostate cancer. This imaging~     procedure provides a multifaceted view of the entire in-situ gland.~      The current use of Prostate Specific Antigen (PSA) for determining the likelihood of presence~     of cancer in the prostate gland requires interpretation and has a good but limited to predict~     prostate cancer on biopsy, with significant false prediction rates. More importantly as a~     blood test, the PSA test lacks the ability to pinpoint the location of the cancer within the~     prostate gland. Preliminary study findings have suggested that Transurethral Ultrasonic~     Scanning (TUUS) presents the desired improved diagnostic sensitivity for detection of cancer~     within the imaged prostate gland, and has the intrinsic capability to provide high resolution~     images of the transverse and future three-dimensional views of the entire gland better than~     currently used Transurethral Ultrasound (TRUS). Two important goals of the practicality of~     this minimally invasive technology will be assessed by this study. 1. The ability of TUUS to~     directly detect prostate cancer locations in the prostate. 2. The use of TUUS to successfully~     guide the prostate needle biopsy to cancer loci with a high rate accuracy.~   "
96233|NCT02307539|"~     This pilot clinical trial studies a palliative care program in improving the quality of life~     of patients with newly diagnosed pancreatic cancer. Palliative care is care given to patients~     who have a serious or life-threatening disease, and focuses on managing disease symptoms,~     side effects of treatment or the disease, and improving patient quality of life. Studying a~     palliative care program used for other types of cancer may help doctors learn whether it can~     improve the quality of life of patients with pancreatic cancer.~   "
96234|NCT02307526|"~     Due to de-centralized cardiovascular control, persons with spinal cord injury (SCI)~     experience blood pressure (BP) dysregulation which manifests in chronic hypotension with~     exacerbation during orthostatic positioning. Although many individuals with SCI remain~     asymptomatic to hypotension and orthostatic hypotension (OH), we recently reported reduced~     memory and marginally reduced attention and processing speed in hypotensive individuals with~     SCI compared to a normotensive cohort. Thus, we believe that treatment of overtly~     asymptomatic hypotension and OH in the SCI population is clinically warranted. Currently the~     FDA has approved only midodrine hydrochloride for the treatment of dizziness associated with~     OH and proof of efficacy is limited. Acetylcholinesterase inhibition for treatment of OH is a~     novel concept and has gained recent recognition in models of neurogenic OH (multiple system~     atrophy; pure autonomic failure, diabetic neuropathy). The physiological rationale of this~     concept is unique: acetylcholine (AcH) is the pre-ganglionic neurotransmitter of the~     sympathetic nervous system. Inhibition of acetylcholinesterase will limit the breakdown of~     AcH thereby facilitating vascular adrenergic tone and peripheral vasoconstriction.~     Acetylcholinesterase inhibition has been reported to be efficacious in models of both~     pre-ganglionic (multiple system atrophy) and post-ganglionic (pure autonomic failure,~     diabetic neuropathy) origin and persons with SCI reflect a model of a preganglionic disorder.~     In theory, if an individual has a complete autonomic lesion, acetylcholinesterase inhibition~     would not be expected to improve orthostatic BP because little/no neural traffic would be~     transmitted to the pre-synapse. However, individuals with an incomplete autonomic lesion may~     benefit from this class of agent. Researchers are currently investigating the orthostatic BP~     effects of acetylcholinesterase inhibition with pyridostigmine bromide (60 mg) in 10~     individuals with SCI.~   "
96235|NCT02307513|"~     Behcet's disease, is a rare disorder that causes inflammation in blood vessels throughout the~     body. The signs and symptoms of Behcet's disease may include mouth sores, eye inflammation,~     skin rashes and lesions, and genital sores that vary from person to person and may come and~     go on their own. The exact cause of Behcet's is unknown, but it may be an autoimmune~     disorder, which means the body's immune system mistakenly attacks some of its own healthy~     cells.~      This study will test whether apremilast is better than placebo (inactive substance in the~     same form as the drug) for the treatment of oral ulcers in subjects with active Behçet's~     disease. Other manifestations of the disease will also be assessed, such as, pain and~     tenderness in joints, eye inflammation, genital ulcers, and skin disease. This study also~     will test how well the body tolerates apremilast.~      This study is a randomized, placebo-controlled, parallel design. About 204 subjects will~     participate. The placebo-controlled period will be 12 weeks long and patients will receive~     apremilast or placebo. After the 12-week placebo-controlled period, all subjects will receive~     apremilast for 1 year. All subjects will have their final study visit 4 weeks after stopping~     apremilast treatment.~   "
96236|NCT02307500|"~     This is a single arm, single-stage, phase II trial to evaluate the activity of Regorafenib in~     patients with metastatic solid tumors (pancreatic cancer, ovarian cancer, melanoma, sarcoma~     who have progressed after standard therapy.~   "
96237|NCT02307487|"~     A prospective, open label, modified 3+3 dose escalation study. This dose-escalation study is~     designed to carefully assess the safety of successive cohorts of patients (3~     patients/cohort), each cohort treated with a fixed dose of TC-3 and MMC Intravesical~     instillations.~   "
96238|NCT02307474|"~     This pilot clinical trial studies the side effects of stereotactic body radiation therapy and~     pazopanib hydrochloride in treating patients with kidney cancer who are not able to undergo~     surgery. Stereotactic body radiation therapy is a specialized radiation therapy that delivers~     high doses of radiation directly to the tumor and may kill more tumor cells and cause less~     damage to normal tissue. Pazopanib hydrochloride may stop the growth of tumor cells by~     blocking an enzyme needed for cell growth. Giving pazopanib hydrochloride before stereotactic~     body radiation therapy may help make the tumor smaller and be an alternative treatment for~     patients who cannot undergo surgery.~   "
96239|NCT02307461|"~     To Evaluate the Bioequivalence of the two formulations of IPI-145 and the Effect of Food on~     the Pharmacokinetics of IPI-145~   "
96240|NCT02307448|"~     This investigation plans to initiate the healing of chronic wounds by providing a~     concentrated platelet and growth factor therapy directly to the wound site by topical~     delivery. This therapy will be derived from autologous platelet rich plasma (PRP), an~     emerging surgical and wound care treatment. This investigation aims to demonstrate that~     patients with chronic, non-healing wounds treated with autologous PRP and standard medical~     care have a reduction in wound volume and improved healing rate that results in~     patient-centered clinically significant health outcomes as compared to patients treated with~     standard medical care only.~   "
96241|NCT02307435|"~     Mesenchymal stem cell (MSC) is one kind of stem cell which is gained form adult tissue.~     Although MSC derived from autogenic bone marrow are proven to help regeneration in non union~     fracture and long bone defect, the aspiration process through iliac crest is invasive and~     painful.~      Therefore, alternative source of MSC which is less invasive is needed. Adipose and umbilical~     cord is a waste product that proven to contain enormous MSC. Furthermore adipose and~     umbilical cord as an allogenic source is more abundant in number compares to autogenic bone~     marrow. This enormous source need and adequate preservation technique before applied to the~     patient. According to that, researchers want to explore the potency of MSC from bone marrow,~     umbilical cord and adipose as the source of allogenic MSC and the effect of cryopreservation~     technique to the viability and quality of MSC. We will also compare the effectivity of MSC~     implantation from bone marrow, umbilical cord and adipose applied to non union fracture and~     long bone defect.~      Samples from bone marrow, umbilical cord and adipose are cultured and the viability of the~     cells are observed. Some of the cells are implanted directly to the patient with non union~     fractures and long bone defect while some are cryopreserved in liquid nitrogen -190 degree~     Celsius in three months. All samples are thawed and the viability of the cells are observed.~     Patient who are implanted by MSC allogenic will undergo clinical and radiological examination~     in the third, sixth and twenty second month after implantation.~   "
96242|NCT02307422|"~     The design and purpose of the current study is to expand and validate previous findings that~     the IL-1 gene cluster composite genotype patterns potentiate the risk for coronary artery~     disease (CAD) and cardiovascular events mediated by OxPL and Lp(a). A secondary objective is~     to validate other, non IL-1 genetic variants associated with CAD.~   "
96243|NCT02307409|"~     This study attempts to clarify the pathophysiology of haemostasis and haematopoiesis in~     relation to the evidence of sepsis in liver disease, and compares the accuracy of various~     available laboratory tests in assessment of these patients. Further research is needed for~     proper understanding of the influence of sepsis on coagulation disorders in ACLF (Acute on~     Chronic Liver Failure) patients in particular, to correctly identify the type and optimal~     quantity of blood product requirement in at risk patients.~      Thromboelastography (TEG) /Sonoclot have been proposed as a superior tool to rapidly diagnose~     and help guide resuscitation with blood products. Secondly, the study of derangement in~     coagulopathy after the onset of sepsis is of paramount importance because of increased~     mortality after the onset of sepsis. In the present study, patients with ACLF (Acute on~     Chronic Liver Failure) without evidence of sepsis on admission will be included in the study~     cohort, and will undergo a baseline diagnostic workup as described. They will be followed for~     development of any signs of infection after hospitalization. Then the effect of sepsis on~     their coagulation and haematopoietic cellular responses will be assessed. Thus the effect of~     sepsis on the progression and outcome of patients with ACLF (Acute on Chronic Liver Failure)~     will be studied.~   "
96244|NCT02307396|"~     The main objective of the trial is to evaluate, how long an antipsychotic relapse-prevention~     should be continued and to which time a patient with schizophrenia is protected enough, so~     that a withdrawal or reduction of the medication seems appropriate. Relapse is defined as~     primary outcome.~   "
96245|NCT02307383|"~     The combination of Lactitol and Probiotics (Lactobacillus acidophilus and Lactobacillus~     Biphidus) administered orally is an effective strategy of intestinal decolonization of~     Enterobacter produced OXA-48-type carbapenemase.~      The purpose of this study is to determine the effectiveness of Lactitol and Probiotics for~     the intestinal decolonization of people who carried Klebsiella pneumoniae produced~     OXA-48-type Carbapenemase.~   "
96246|NCT02307370|"~     The primary objective for this study is to prove the safety and effectiveness of the~     Spectranetics Turbo-Elite catheter in atherectomy treatment for infrainguinal arteries with~     catheter to vessel sizing of at least 50%.~   "
96247|NCT02307357|"~     Habitual physical activity was found to be positively related to better health and~     well-being. One of the most popular physical activity forms is ball games. In Israel, there~     is a growing popularity in a new ball game - Newcomball - which is being played by many~     middle age, non-athlete, women. However, so far, no study had evaluated the contribution of~     the game to improvement in the participants' physical fitness. The aim of this study,~     therefore, is to evaluate the effects of six month two weekly Newcomball training sessions to~     the physical fitness of middle age women.~   "
96248|NCT02307344|"~     The investigators hypothesize that Nigella Sativa will have an effect on Nonalcoholic~     Steatohepatitis and Liver Steatosis by enhancing lipophagy in the liver tissue.~   "
96249|NCT02307331|"~     The purpose of this study is to evaluate the efficacy and safety of the Sirius Cemented Stem~     used in conjunction with the Exceed ABT Cemented Acetabular Cup, either with E1 or Arcom~     polyethylene, and OptiPac/OptiVac bone cement mixing systems.~   "
96250|NCT02307318|"~     A recent pilot study conducted at HealthEast found use of manual pressure with the SoftSeal~     hemostatic pad for 15 minutes was successful in 9 out of 10 people fully anticoagluated using~     4 French radial sheath. There was no evidence of radial artery occlusion in this small sample~     and bleeding was limited to grade 1. This evidence supports a larger retrospective study to~     confirm these results and define an alternative to the TR band use post radial artery access~     for cardiac catheterization.~      Primary Objective Determine the incidence of arterial bleeding after real-world use of~     SoftSeal hemostatic device at a transradial access site with a 4 French system with with~     manual pressure by compression of the ulnar artery.~      Secondary Objective Determine the incidence of thrombosis at the access site in all subjects~     as presence of thrombus in the radial artery by reverse barbeau test; the incidence of~     changes in circulation, movement and sensation (CMS) in the hand and wrist on the impacted~     hand; and the incidence of hematoma and ecchymosis, assessed just prior to discharge.~   "
96251|NCT02307305|"~     Range from 24% to 44%, with a prevalence of neuropathic-type pain from 6% to 20%-cause~     impairment in quality of life and functional capacity after total knee arthroplasty(TKA).~     Duloxetine (cymbalta) is a selective serotonin and nor-epinephrine reuptake inhibitor shown~     to be effective in treating chronic pain. Serotonin and norepinephrine in the brain and~     spinal cord are believed to both mediate core mood symptoms and help regulate the perception~     of pain. Its effects on depression and anxiety symptoms, as well as its effect on pain~     perception, may be due to increasing the activity of serotonin and norepinephrine in the~     central nervous system. Approved for the acute and maintenance treatment of major depressive~     disorder, the acute treatment of generalized anxiety disorder, the management of diabetic~     peripheral neuropathic pain and the management of fibromyalgia, all in adults (18+).~      Investigators will compare the neuropathic pain following TKA in duloxetine group (n=84) with~     those in non-duloxetine group (n=84). Investigators will classify the participants in to 2~     groups (duloxetine and non-duloxetine group) randomly, and primarily evaluate the degree of~     neuropathic pain using the S-LANSS pain scale (preoperatively and postoperatively 3 and 6~     months). All participants will receive postoperative pain control after TKA using the same~     pain control regimen except duloxetine.~   "
96252|NCT02307292|"~     This is a prospective, non-randomized post market surveillance registry designed to document~     the clinical Performance in Routine clinical practice of the POLARIS Peripheral Vascular Self~     Expanding Stent System~   "
96253|NCT02307279|"~     This study will asses the decrease in body weight after repeated administration of Gelesis100~     in overweight and obese subjects with and without Type 2 Diabetes.~   "
96254|NCT02307266|"~     This is a multi-center, randomised and controlled study in subjects with acne vulgaris. The~     main objective of this study is to evaluate the effect of a supplementary patient education~     intervention (in addition to the standard-of-care patient education) on treatment adherence~     and satisfaction among acne patients receiving once-daily EpiduoTM gel treatment in primary~     care clinics.~   "
96255|NCT02307253|"~     This study evaluates the feasibility, safety and accuracy of a 19 gauge (19G) needle in~     nitinol in the performance of endoscopic ultrasound (EUS) guided transduodenal biopsy for the~     acquisition of samples for histologic analysis. Patients with lesions that can be approached~     only from the duodenum will be prospectively enrolled.~   "
96257|NCT02307227|"~     Prospective, monoinstitutional, phase II study. Patients with HER 2 positive locally advanced~     breast cancer will be treated with 3 initial cycles (12 weeks) of trastuzumab plus paclitaxel~     and then if responding further 12 weeks and then with surgical resection, patients with HER2~     negative breast carcinoma will be treated with 4 cycles (12 weeks) of epirubicin and~     taxotere. If responding 4 more cycles (12 weeks). Patients progressing will be treated~     depending on physician's and patient's preference~   "
96258|NCT02307214|"~     Tako-Tsubo Cardiomyopathy (TTC) and Cardiac Syndrome X (CSX) are respectively acute and~     chronic cardiac conditions whose clinical presentation, mimicking the onset of acute~     myocardial ischemia in absence of epicardial coronary disease, has progressively gained the~     interest of the scientific community. However, despite significant progress, their underlying~     pathophysiology, which seems to evoke some similarities, still remains elusive. Endothelial~     dysfunction and autonomic imbalance have both been individually implied in their puzzling~     pathogenesis.~      The investigators plan to conduct our study in a cohort of TTC patients, CSX patients and~     healthy volunteers with the following primary objective: to assess the response of~     endothelial function (through the Endopat score) to the autonomic tone activation induced by~     a 10-minute stress mental test. The assessment of autonomic tone during activation through~     the evaluation of Spontaneous BaRoreflex Sensitivity (BRS) and its correlation with~     endothelial function (Endopat score) will represent secondary objectives.~      Our study will enroll 15 patients with TTC at least six months after the event, 15 patients~     with classic CSX and 15 healthy volunteers who will serve as control.~   "
96259|NCT02307201|"~     There is no evidence that patients receiving magnesium sulfate before birth are required to~     maintain the drug for 24 hours. Therefore the investigators will have a randomized clinical~     study in patients with severe preeclampsia who have been treated with impregnation of~     magnesium sulphate and at least eight hours have received the drug before birth. If the~     patient agrees and signs the consent is randomized to: 1-receive sulfate for 24 hours~     postpartum as usual or, 2- not receiving the postpartum magnesium sulfate or other~     anticonvulsant drugs. This study can be conducted in 12 maternity latin america.~   "
96260|NCT02307188|"~     This clinical investigation utilizes the Constellation Full Contact Mapping catheter in the~     left and right atria to explore atrial signal characteristics that can guide atrial~     fibrillation and atrial flutter ablation procedures more effectively.~   "
96261|NCT02307175|"~     Prospective, open label single site study to demonstrate the safety and efficacy of Tc-99m~     pertechnetate produced by high energy cyclotron at CHUS.~   "
96262|NCT02307162|"~     The purpose of the study is to assess the safety of single doses and multiple doses of a new~     formulation of RPL554 in healthy subjects and subjects with chronic obstructive pulmonary~     disorder.~   "
96263|NCT02307149|"~     Open label, single arm study of intratumoral CVA21 and ipilimumab in advanced melanoma~     patients.~   "
96264|NCT02307136|"~     This multicenter cohort aims to assess the impact of within-hospital trajectories of patients~     admitted in intensive care units from emergency departments on vital prognosis of patients,~     duration of hospital stay and hospital costs.~      As secondary objectives, the study will:~        -  assess the impact of clinical and demographic characteristics on hospital trajectories~          of patients.~        -  assess the impact of emergency units workload, beds availability in medical units and in~          intensive care units, and global hospital organisation on patients care trajectories.~   "
96265|NCT02307123|"~     The primary aim of this study was to describe the long-term outcome of critically ill or~     severely injured patients not in cardiac arrest treated by an EMS physician.~   "
96266|NCT02307110|"~     This study is designed to evaluate the prevalence of different stages of diabetic retinopathy~     and diabetic macular edema among patients suffering from type 1 diabetes (DM 1) for 5 to 25~     years and have been treated with intensified insulin therapy aiming near-normal blood glucose~     levels for the whole duration of disease.~      Prevalence of different stages of diabetic retinopathy and diabetic macular edema is assessed~     using the modified Airlie House classification and the Early Treatment Diabetic Retinopathy~     Study (ETDRS) retinopathy severity scheme. Results of this study will provide the basis for~     designing further studies as well as staging and screening guidelines for diabetic~     retinopathy/diabetic macular edema.~   "
96267|NCT02307097|"~     The efficacy of high-intensity Cognitive-Behavioural Therapy (CBT) for social anxiety~     disorder is well established (Mayo-Wilson et al., 2014) and it is recommended by the National~     Institute of Health and Clinical Excellence (NICE) as the first-line psychological~     intervention for social anxiety disorder. The treatment aims to modify several maintenance~     factors (e.g., self-focused attention) that are specified in cognitive models of social~     anxiety disorder (e.g., Clark & Wells, 1995).~      Cognitive-behavioural self-help treatments for social anxiety disorder have been developed to~     overcome various accessibility issues (e.g., long wait-lists, and the patient's need to avoid~     social situations, etc) associated with high-intensity CBT (Abramowitz et al., 2009;~     Carlbring et al., 2007) but a recent network meta-analysis (Mayo-Wilson et al., 2014)~     identified the former as less cost-effective than the later and thus, they are not~     recommended as standalone treatments.~      However, the potential benefit of cognitive-behavioural self-help treatments for social~     anxiety disorder within a stepped-care recovery model as a prelude to high-intensity CBT has~     not been formally evaluated.~      The aim of this study is to evaluate a seminal Cognitive-Behavioural Bibliotherapy* (CBB;~     pure self-help book) - 'Overcoming Social Anxiety & Shyness' (Butler, 2009) - for patients~     with social anxiety disorder while on the wait-list for high-intensity CBT within an~     Improving Access to Psychological Therapies (IAPT) service, and to determine if some patients~     recover from CBB alone or whether there may be a reduction in the average number of~     high-intensity CBT sessions for those patients who subsequently require further treatment.~      The study is funded by Constable & Robinson, Kellogg College (University of Oxford) and~     Talking Change (Solent NHS Trust).~      * The Reading Well Books on Prescription scheme with funding from the Arts Council England~     enables general practitioners (GPs) and mental health professionals to prescribe seminal CBBs~     for patients with mood and anxiety disorders. The books are accessed free of charge via local~     libraries. The scheme works within NICE guidelines and it is support by the Royal Colleges of~     GPs, Nursing and Psychiatrists, the British Association for Behavioural and Cognitive~     Psychotherapies and the Department of Health through its IAPT programme.~   "
96268|NCT02307084|"~     The long saphenous vein is traditionally harvested for use as a conduit in coronary artery~     bypass grafting surgery. Currently, the long saphenous vein is not imaged prior to surgery.~     This study aims to evaluate preoperative ultrasound mapping of the long saphenous vein to to~     improve patient and clinical outcomes.~   "
96269|NCT02307071|"~     This study evaluates the effect in chronic migraine patients of daily 20~     minute-transcutaneous sub occipital neurostimulation using the occipital Cefaly° device.~   "
96488|NCT02304211|"~     The purpose of this protocol is to demonstrate that intra-arterial administration of a drug~     can generate information in a manner that faithfully mimics effects of systemic~     administration but with little or no systemic effects.~   "
96270|NCT02307058|"~     The BLaStM clinical trial extends the Phase I LEAD trial and compares the LEAD SBRT upfront~     technique for increasing dose to the MP-MRI defined GTVs to the HEIGHT method of using a~     moderate hypofractionated simultaneous integrated boost to the MP-MRI defined GTVs through~     the course of radiotherapy. The hypothesis is that alternate mechanisms of cell death,~     including bystander effects, are put in place when doses above 8 Gy per fraction are used in~     a lattice on the first day of treatment and that the effects on local tumor eradication will~     be greater using this strategy.~   "
96271|NCT02307045|"~     The integrity of endothelial glucocalyx plays a vital role in vascular permeability and~     inflammation. Smoking cessation is related with improved vascular function and is a key~     component of secondary cardiovascular prevention. Pharmacotherapy is a standard component of~     evidence based smoking cessation treatment. This study was designed to determine the effects~     medically-aided smoking cessation on glucocalyx thickness and arterial elasticity smoking~     cessation programs~   "
96272|NCT02307032|"~     Atrial Fibrillation (AF) is a common arrhythmia with a prevalence of 1.5-2%. This prevalence~     increases significantly after 80 years of age. After the appearance of first episode(s) some~     of the patients will present frequent arrhythmia recurrences moving from the paroxysmal~     status to the persistent and the permanent status of the continuous spectrum of the natural~     time course of AF. In contrast some other will not present further relapses. To study and~     predict the dynamic evolution of AF is clinically important, furthermore, the detection of~     different sub populations risk for AF relapses will determine and different therapeutic~     approaches.~   "
96273|NCT02307019|"~     The purpose of this study is to analyze the effects of a intervention on a specific health~     prevention/intervention program aimed at caregivers of mild and moderate patients post stroke~     with upper limb apraxia in comparison to a control group with a no specific formation in that~     kind of patients.~   "
96274|NCT02307006|"~     The study is a randomized double-blinded study comparing ceftaroline to standard of care~     therapy with cefazolin and vancomycin as surgical prophylaxis for high risk orthopedic and~     cardiac surgeries. Study participants will be enrolled from those undergoing cardiothoracic~     surgery involving sternotomy and those undergoing prosthetic joint replacement of either hip~     or knee. Consenting patients will be randomized 2:1 to receive either ceftaroline or~     cefazolin/vancomycin. This study will be blinded by the use of placebo vancomycin infusions~     and placebo cephalosporin infusions. The primary end point will be the development of a~     surgical site infection within 30 days of surgery.~   "
96275|NCT02306993|"~     This research study has two purposes. The first purpose is to determine whether having sickle~     cell trait (SCT) is a risk factor for the development of bone thinning at an earlier age than~     expected. Nearly 10% of African Americans (AA) carry sickle cell trait and most of them are~     unaware of it. African Americans are less likely to develop thin bones than whites, but if~     they sustain a bone fracture, they are more likely to die from it. We believe having sickle~     cell trait may lead to bone thinning and predispose a subset of African Americans to~     dangerously thin bones. The second purpose is to try to understand why individuals with~     sickle cell disease (SCD) have thinner bones than healthy individuals do. Doctors have~     already discovered that people with sickle cell disease have very thin bones, but they have~     not determined why. Our study will try to identify whether the bone thinning is from the body~     not making enough bone or from the body losing bone once it is made.~   "
96276|NCT02306980|"~     Oropharyngeal administration of mother's colostrum to premature infants has been proposed as~     a stimulus to the oropharyngeal lymphatic tissues to decrease the incidence of pneumonia and~     sepsis, particularly in intubated babies. We propose to study the impact of this intervention~     on the composition of the oral microbiota.~   "
96277|NCT02306967|"~     Studies from Vancouver show that fluorescent visualization (FV) is a useful method of~     controlling surgical margins. This early finding will now be confirmed in a national~     randomized controlled trial.~   "
96278|NCT02306954|"~     All patients will receive IL-2 (14 planned doses with an additional cycle 14 days after the~     first). Responding patients with regressing disease are eligible for up to 6 IL-2 cycles.~     Patients assigned to SBRT arm will receive two doses of SBRT on the Wednesday and Friday~     before the Monday on which IL-2 starts.~   "
96279|NCT02306941|"~     This pilot-study aims to evaluate the treatment effects and feasibility of an~     internet-delivered CBT-program adjusted for adolescents with functional abdominal pain and~     functional dyspepsia.~   "
96280|NCT02306928|"~     Antibiotic dosing in septic shock patients poses a challenge for clinicians due to the~     pharmacokinetic changes seen in this population. Piperacillin/tazobactam is often used for~     empirical treatment, and initial appropriate dosing is crucial for reducing mortality.~      We determined the pharmacokinetic profile of piperacillin 4g every 8 hour in 15 patients~     treated empirically for septic shock. A PK population model was established with the dual~     purpose to assess current standard treatment and to simulate alternative dosing regimens and~     modes of administration. Time above the minimal inhibitory concentration (T>MIC) predicted~     for each patient were evaluated against clinical breakpoint MIC for Pseudomonas aeruginosa~     (16 mg/L). Pharmacokinetic-pharmacodynamic (PK-PD) targets evaluated were 100% f T>MIC and~     50% fT>4xMIC.~   "
96281|NCT02306915|"~     Cohorts of Japanese participants will be enrolled and treated prior to cohorts of Caucasian~     participants for the sake of matching. Every effort will be made to match Caucasian and~     Japanese participants on a cohort basis at enrollment. Reasonable effort will be made to~     maintain balance between male and female participants within the cohorts. There will be no~     replacement of participants following randomization.~   "
96282|NCT02306902|"~     The study was conducted as an open-label, balanced, randomized, two-treatment, two-period,~     two-sequence, single-dose, crossover, bioequivalence study comparing Fenofibrate capsules,~     USP 130 mg manufactured by Ohm Laboratories Inc, NJ 08901 with ANTARA® (fenofibrate) capsules~     130 mg manufactured by Ethypharm Industries Saint Cloud, France for Oscient Pharmaceuticals~     Corp. Waltham, MA 02451 in healthy, adult, male, human subjects under fed condition.~   "
96283|NCT02306889|"~     The study was conducted as an open label, balanced, randomized, two-treatment, two-period,~     two-sequence, crossover bioequivalence study comparing a single oral dose of fenofibrate~     capsules, USP 130 mg, of Ohm Laboratories Inc. USA (a subsidiary of Ranbaxy Pharmaceutical~     Inc.) with Antara® (fenofibrate) Capsules 130 mg of Oscient Pharmaceuticals Corporation USA,~     in healthy, adult, male, human subjects under fasting condition.~   "
96286|NCT02306850|"~     This study is being done to see if using the study drug, pembrolizumab, can shrink down~     melanoma tumors enough so that they will be small enough to cut out, so that there will be no~     cancer left in the body.~      Eligible participants include those who have not received any systemic melanoma therapies~     (i.e. participants do not have to fail ipilimumab or BRAF inhibitor) and those who have~     failed all available systemic options (if the participant meets other inclusion / exclusion~     criteria).~   "
96287|NCT02306837|"~     To imporve the outcome of patients with relapsed/refractory lymphoma, we conduct a clinical~     trial to test the efficacy and feasibility of consolidation chemotherapy after autologous~     stem cell transplantation~   "
96288|NCT02306824|"~     Investigator-initiated prospective multicentre hospital-based registry to uncover the~     proportion of self-reported anticoagulation in stroke patients with atrial fibrillation and~     assessing the proportion of stroke, intracranial bleeding and all-cause death in the short~     (at 3 months), mid-term (at 12 months) as well as long term (at 24 months) after ischemic~     stroke or transient ischemic attack in an unselected urban population in Germany.~   "
96289|NCT02306811|"~     Primary Objective:~      To assess the long-term safety of vatelizumab in MS patients~      Secondary Objective:~      To assess the long-term efficacy of vatelizumab~   "
96290|NCT02306798|"~     This is a Phase I, open-label, single-site trial to evaluate the drug release, using~     scintigraphic images and mesalazine plasma levels (PK) in healthy subjects. Overall, nine [9]~     subjects will be evaluated. The subjects will receive one [1] radio-labelled tablet after a~     high fat and a rich in calories breakfast.~   "
96291|NCT02306785|"~     This is a Phase I, open-label, single-site trial to evaluate the drug release, using~     scintigraphic images and mesalazine plasma levels (PK) in healthy subjects and patients with~     mildly active UC. Overall, nine [9] subjects per prototype coating (a total of 18) will be~     evaluated. Four [4] healthy subjects and five [5] patients will be administered one [1]~     radio-labelled tablet of either formulation D or formulation E, respectively.~      Amendment: Overall, nine [9] subjects/patients will be evaluated. Four [4] healthy subjects~     and five [5] patients will be administered one [1] radio-labelled tablet of this new third~     improved formulation H.~      In order to keep the number of patients low, recruitment of patients will be stopped when~     obtaining at least 3 patients with evaluable scintigraphic images. Healthy volunteers will~     then be recruited to achieve a full set of participants (n=9 per Arm).~   "
96292|NCT02306772|"~     This is a Phase I, open-label, single-site trial to evaluate the drug release, using~     Scintigraphic images and mesalazine plasma levels (PK) in healthy subjects. Overall, nine [9]~     subjects per prototype coating (a total of 18) will be evaluated. Eligible subjects will be~     assigned in a 1:1 ratio to receive radio-labelled TP05; the first 9 subjects will receive~     formulation B and the second 9 subjects will receive formulation A. The subjects will be~     treated once with the radio-labelled study medication.~   "
96293|NCT02306759|"~     The aim of the study is to compare the safety & efficacy of low dose ketamine and morphine~     versus morphine alone for acute generalized pain in the Emergency Department (ED). The~     investigators are also interested to investigate whether low-dose ketamine is a safe and~     effective alternative option to opioids for the acute treatment of pain in the Emergency~     Department.~      The agents that are available in the department includes acetaminophen, non-steroidal~     anti-inflammatory (NSAIDS) and opioids. In most cases, acetaminophen and NSAIDS are not~     adequate to manage acute pain crisis. There is also heightening concerns for increased opioid~     use or abuse by patients. Since the HCAPHS survey includes various questions which inquires~     about patient perception of pain management in the department, the investigators are~     interested in investigating the safety and efficacy of low-dose ketamine to as an alternative~     method to opioids for the acute management of pain. There has been limited, mostly~     observational pilot studies, published in the literature. Limited data in the literature have~     reported the incidence of nausea and vomiting ranged from 3-13%. All published literature~     administered low-dose ketamine as an intravenous push. To the best of our knowledge our study~     would be the first study to administer low-dose ketamine as a short bolus infusion to~     mitigate the incidence of nausea and vomiting. The investigators believe our study would~     provide important scientific data to fill the theoretical gap that low-dose ketamine at~     0.3mg/kg/dose may be a safe and effective agent for acute pain management in an ED that is~     located in the center of a densely populated urban area.~   "
96294|NCT02306746|"~     Nutrition therapy is an essential standard of care for all critically ill patients who are~     mechanically ventilated and remain in the intensive care unit for more than a few days.~      The investigators plan to conduct a 4,000 patient, double-blind, randomised controlled trial~     to determine if augmentation of calorie delivery using energy dense enteral nutrition in~     mechanically ventilated patients improves 90 day survival when compared to routine care.~   "
96295|NCT02306733|"~     200 women with PPH will be randomly divided into 2 equal groups using computer generated~     random numbers. Group 1 will receive Ergometrine 400µgm (Methergin® Novartis, Switzerland)~     and group 2 will receive oxytocin 10 IU (Syntocinon®, Novartis, Switzerland). The~     investigators will not include a control group for ethical reasons.~   "
96296|NCT02306720|"~     To collect and evaluate long-term safety and effectiveness data in HPP patients who have/ are~     receiving treatment with asfotase alfa.~   "
96297|NCT02306707|"~     A patient referred to have a lesion in the stomach removed. The aims of this study are to~     collect information on the technique of endoscopic removal of such lesions. By collecting~     information on a large number of patients undergoing this procedure the investigators can~     determine the best ways of diagnosing and removing these lesions safely and effectively.~   "
96298|NCT02306694|"~     One of the major shortcomings in studying bone disease in hemophilia is the lack of fracture~     outcome data demonstrating the clinical significance of decreased BMD and altered bone~     biomarkers in the hemophilia population. This study demonstrates that PwH have an increased~     risk of fracture compared to the general population and that the issue of bone health will~     increase in importance as the PwH population ages.~   "
96299|NCT02306681|"~     This study is conducted globally. The aim of this study is to describe the proportion of~     patients with hypoglycaemic episodes and estimate the incidence of various types of~     hypoglycaemia in the retrospective and prospective periods.~   "
96489|NCT02304198|"~     This study evaluates the long-term safety of Udenafil in Patient with Pulmonary Arterial~     Hypertension(PAH). All the patients will receive Udenafil for 1-year(48-weeks).~   "
96300|NCT02306668|"~     The investigators seek to characterize the identity of all microorganisms residing on the~     eye's surface (conjunctiva) in healthy eyes and those with dry eye syndrome, using a~     combination of analyses. Dry eye disease is thought to have an inflammatory basis and in the~     vast majority of cases the cause of the chronic inflammatory condition is unknown.~   "
96301|NCT02306655|"~     Fundamentals of scientific research The coital incontinence (IC), defined as the~     involuntary loss of urine in association with sexual intercourse. The incidence reported in~     the literature ranges from 10% to 27%, but is likely to be underestimated because of the~     embarrassment of the woman to report the disturbance. It was in fact estimated that only 3%~     of women speaks spontaneously to their doctor, and increases up to 20% only after a request~     by the medical staff.~      The CI is traditionally divided into two forms:~        1. incontinence at the time of penetration (60% of cases)~        2. incontinence during orgasm (40% of cases) Many theories have been proposed to justify~          this form of urinary incontinence, but none has been conclusively proved .Moreover, it~          has not been possible, to date, to identify risk factors, anatomical or urodynamics, for~          this condition.~      The IC is rarely a symptom isolated, but more frequently associated with other forms of~     urinary incontinence. In particular, the IC during penetration of associated with stress~     urinary incontinence (loss of urine that occurs due to coughing, sneezing and in general to~     all those activities that increase abdominal pressure); the IC during orgasm is associated~     more frequently to a condition of overactive bladder (presence of urgency, urge incontinence,~     increased urination day and night).~      The IC has a strong impact on female sexuality and can cause loss of libido, non orgasmic,~     decreased sexual satisfaction and, in some cases, termination of sexual activity.~      Research goals Evaluate a prospective investigation of health statistics, the incidence of~     coital incontinence into consideration that there are few data in the literature on this~     disorder and those who have reported a wide variance probably connected to how the data~     collection. The aim is to be able to identify a threatening condition which, if not~     evaluated, worsens the prognosis of the treatment of female urinary incontinence, a condition~     that has a negative impact on the quality of life of patients with significantly worse than~     that related to other recognized debilitating chronic diseases such as diabetes.~      And this individual psychosocial cost, hardly quantifiable, must be added the cost of~     significant socio-economic and welfare dependents of incontinent patients, the community and~     national health services. It is indeed evident from international and national literature~     that the more incisive and determined is the strategy of information, awareness and~     education, and adopted much wider and earlier the diagnosis, the more significant is the~     socio-economic savings, as well as psycho social, we get.~      Ultimate goal is to differentiate between them the two forms of incontinence coital (to~     penetration and during orgasm) because each of them is associated with pathogenesis and~     therefore to a separate treatment. And while the forms of IC penetration favorably affected~     the treatment of stress urinary incontinence, the forms of IC during orgasm, usually~     associated with a functional disorder of the detrusor (detrusor overactivity) show an~     inferior efficacy to treatment antimuscarinic traditionally reserved to the condition of~     overactive bladder and therefore need a more targeted diagnostic and individualized~     treatments.~      Materials and methods~      Self administered questionnaires will be dispensed to the patients The~     questionnaires,validated in Italian language, will be used, according to the guidelines of~     the International Consultation on Incontinence, :~        -  ICIQ-UI on urinary incontinence short-form: for the evaluation of symptoms and quality~          of life:~        -  Patient Perception of Bladder Condition (PPBC): to assess the impact of such a~          subjective condition;~        -  Urinary incontinence and quality of sexuality;~        -  Urinary incontinence and frequency of sexual activity; The questionnaire is anonymous in~          order to protect privacy. The patients will be recruited at the outpatient surgery and~          Urogynaecology urodynamics of Urology Clinic of the University of Perugia.~      The investigators defined that the statistically significant number of subjects can not be~     less than 200 units.~      The time duration of the collection of medical records was estimated at two years.~      There are no extremes of the conflict of interest, will not be tested or used drugs or~     medical equipment.~   "
96302|NCT02306642|"~     The purpose of this study is to learn more about how to identify signs of early chronic~     kidney diseases in children who were born prematurely with low birth weight (less than 3 ½~     pounds). Researchers plan to compare the kidney function in children who experienced acute~     kidney injury (AKI) in the Neonatal Intensive Care Unit (NICU) with those who did not~     experience it. Evidence from several studies and our experience at UVA show that older~     children who experienced AKI while in the Pediatric Intensive Care Unit (PICU) have increased~     risk of developing early chronic kidney disease, and they also show early changes in the~     urine and blood that is consistent with early chronic kidney disease. In this study, the~     investigators hope to determine if any of these changes can be detected in early childhood,~     and if so, at what age we can start detecting these changes.~   "
96303|NCT02306629|"~     To assess how the absolute bioavailability, dose proportionality, pharmacokinetics, safety~     and tolerability of epratuzumab compared when given as a subcutaneous (sc) injection as to~     when given as an intravenous (iv) infusion in Caucasian and Japanese healthy volunteers.~   "
96304|NCT02306616|"~     To develop and implement quality improvement programs for the treatment of acute coronary~     syndrome (ACS) in China based on the successful experience of the AHA-Get with the Guidelines~     program. This two-year program will use data collection, analysis, feedback, and process~     improvement to extend the use of evidence-based guidelines throughout the healthcare system~     and improve patient care of acute coronary syndrome.~   "
96305|NCT02306603|"~     This research project, 'Outcomes of endoscopic resection of mucosal and submucosal lesions in~     the duodenum and ampulla'. The research project is aiming to determine the most effective and~     safe way to remove such lesions.~   "
96306|NCT02306590|"~     The primary objective of the trial is to investigate the survival time (the time from~     randomization until death or date of end of the study) compared between control group and~     experimental group.~      This is a prospective, multicenter, randomized, stratified, parallel-group, double-blind~     trial comparing placebo with high caloric fatty diet for drinking as add-on therapy to 100 mg~     riluzole in amyotrophic lateral sclerosis (ALS) in 200 enrolled patients. For entry, the El~     Escorial Criteria for the diagnosis of ALS will be used. The patients have to be stable on~     riluzole at least 4 weeks prior to randomization.~   "
96307|NCT02306577|"~     The SINNR study will evaluate the virologic efficacy (viral load <50 copies/mL)and safety of~     STRIBILD administered for 48 weeks to HIV-infected current or recent illicit drug users.~   "
96308|NCT02306564|"~     The purpose of this study is to determine the effect of giving cabergoline to patients at~     risk of OHSS (ovarian hyperstimulation syndrome) after ovum pick up, on endometrial~     vascularity and it's effect on pregnancy outcome~   "
96309|NCT02306551|"~     The purpose of this study is to establish a cohort of pregnant women with severe mental~     disorder and to identify biological and psycho-social transmission mechanisms involved in the~     development of 'risk' and 'resilience' in the offspring. It is assumed that both 'resilient'~     and 'risk' development in offspring are caused by a complex interaction between multiple~     biological, psychological and social factors. The project focuses specifically on exploring~     the impact of physiological stress-sensitivity, attachment, care-giving and the familial and~     social context for care-giving. Previous studies support these factors as important for the~     development of these infants, but systematic research using a prospective design is needed to~     strengthen evidence and elucidate the importance of these factors in more detail. The~     interaction over time of physiological stress-sensitivity, attachment, care-giving and the~     familial and social context for care-giving are evaluated in terms of the evolution of very~     early indicators of developmental risk and resilience in infants with a known highly~     increased risk for developing a mental disorder.The findings of the study may potentially~     lead to more specific targets for preventive interventions, which can improve developmental~     outcome for these infants.~   "
96310|NCT02306538|"~     Breast cancer is the most common cancer amongst Canadian women. 15-20% of early breast~     cancers have high levels of a protein called HER2 which is associated with worse survival.~     Treatment of these patients with anthracyclines followed by trastuzumab (which targets HER2)~     improves survival. Unfortunately, these medications together can cause heart muscle injury~     resulting in heart dysfunction or failure in about 14% and 3.6% of the patients,~     respectively. Once heart failure (HF) occurs, about 60% of patients will not live past 2~     years. Studies have suggested that patients with heart injury caused by anthracyclines may be~     more likely to develop HF with addition of trastuzumab. Therefore tests to find early heart~     injury after anthracyclines may allow doctors to start heart protective medications with the~     hope of preventing HF. Also, animal and small patient studies have shown that an increase in~     the water levels of the heart muscle (edema) may be an early sign of heart injury from~     anthracyclines. Cardiac MRI is a unique technique that has been shown to detect edema in~     various heart diseases.~      The investigators will test the theory that, in women receiving treatment for breast cancer,~     heart edema detected by MRI at the end of anthracyclines will identify patients who will~     later develop heart dysfunction. MRI studies with novel techniques will be done pre-therapy,~     after anthracyclines, during herceptin, and at end of all therapy. The investigators will~     compare patients with and without heart dysfunction to test if patients with heart~     dysfunction are more likely to have edema after anthracyclines. Ultimately the investigators~     hope to use cardiac MRI to identify high risk patients and study various heart protective~     medications to prevent HF. This will improve the personal health of cancer patients by~     allowing them to live free of heart disease after their cancer therapy. Ultimately at a~     population level this will allow doctors to provide care that can be uniquely designed for~     each patient based on their individual risk.~   "
96311|NCT02306525|"~     Purpose: The aim of this prospective cohort is to evaluate patients before, 6 and 12 months~     after arthroscopic surgery for FAI and compare the results to people without hip problems.~      Methods/design: Sixty patients with FAI and 30 persons without hip problems will be included.~     Pre- and postoperatively, patients will be evaluated by CT-scans. All participants will have~     their hip flexor and extensor muscle strength assessed and have performed kinetic and~     kinematic analyses of daily activities with 3D motion capture. Further, self-reported~     questionnaires on hip related pain, quality of life and sports activities will be collected.~     Finally, participants will have their daily physical activity monitored with tri-axial~     accelerometers for five consecutive days.~      Perspectives: With this prospective cohort study the outcome of arthroscopic treatment of FAI~     within one year after surgery will be evaluated. If the patients fail to reach reference~     values one year after surgery, altered surgical procedures or rehabilitation programs to~     optimize treatment for the patients may be explored in future studies. Further, the~     investigators expect to perform long-term follow up to evaluate reoperations, conversions to~     total hip arthroplasty and development of osteoarthritis for the patients surgically treated~     for FAI.~   "
96314|NCT02306486|"~     The aim of this double-blind randomized controlled clinical trial was to evaluate the effect~     on dentin sensitivity using oxalic acid desensitizing agent before restoring with~     resin-based-composites, during one-year follow-up. One hundred and twenty two cervical~     lesions (31 patients, age range between 24 and 66 years) were selected and randomly divided~     into four groups: OA/Z250: treated with acid oxalic desensitizing agent (Desenssiv, SSWhite)~     before restoring with a methacrylate resin-based-composite (Z250, 3M ESPE), (n=31), OA/P90~     treated with acid oxalic desensitizing agent (Desenssiv, SSWhite) before restoring with a~     silorane resin-based-composite (Silorane p90, 3M ESPE) (n=31), Z250 restored with~     methacrylate resin-based-composite (Z250, 3M ESPE) (n=30) and P90 restored with a silorane~     resin-based-composite (Silorane p90, 3M ESPE) (n=30). All lesions were evaluated at baseline,~     immediately and 1, 2, 3, 6 months and 1 year after treatment. Teeth sensitivity was measured~     by visual analog scale (VAS) after evaporation and tactile stimuli~   "
96315|NCT02306473|"~     This is a clinical trial designed to test the hypothesis that measuring the absorption and~     excretion of inhaled mannitol will provide a clinically useful marker of airway epithelial~     permeability in asthma.~   "
96316|NCT02306460|"~     Atrial fibrillation is a common arrythmia. It is an independent risk factor for stroke. There~     for anticoagulation therapy is used for atrial fibrillation patients. Alternatively, left~     atrial appendix closure can be used, if the risk for bleeding complications is deemed greater~     than the possible antithrombotic benefit of anticoagulation medication. Up to 70% of ischemic~     complications can be prevented with anticoagulation therapy, and left atrial appendix closure~     seems to have comparable results. Also left atrial catherter ablation (LACA) is gaining~     popularity as a therapeutic intervention for atrial fibrillation.~      However, the procedure is associated with 0,5-1% perioperative risk of clinically evident~     transient ischemic attack (TIA) or stroke. While the incidence of clinically evident ischemic~     complications remain relatively low, recent data suggest that 13%-20% of patients undergoing~     LACA are affected by post-operative neurocognitive dysfunction (POCD) 90 days after ablation.~      The goal of the study is to improve detection of subtle brain dysfunction after cardiac~     interventions by employing an experimental executive reaction time (RT) test along with EEG~     recording in aims to improve objective detection of subtle brain dysfunction assumed to~     underlie persistent cognitive, somatic, and affective complaints reported by patients who~     have undergone atrial fibrillation ablation.~   "
96317|NCT02306447|"~     Magnetic stimulation of the brain (repetitive transcranial magnetic stimulation) and of neck~     muscles (repetitive peripheral muscle stimulation) is used to alter tinnitus-related cortical~     activity and neck muscles tension.~   "
96318|NCT02306434|"~     Childbirth related fear is a public health issue strongly related to subsequent reproduction,~     a request for caesarean section and women's and children's health. Currently, women are~     offered 3-5 counseling sessions with specially trained midwives and obstetricians in most~     Swedish hospitals as standard care (SC). In general, women are satisfied with counseling but~     research show no major effect on cesarean section rates neither in decreased level of~     childbirth related fear. It is therefore important to find the best available treatment for~     this issue.~      The aim of this program is to compare Internet given cognitive behavior therapy (ICBT) with~     standard counseling care for pregnant women reporting childbirth related fear.~      Research questions: What effect does ICBT compared to SC have on a) the level of childbirth~     related fear b) a request for cesarean section c) compliance and satisfaction with treatment.~      Design: A randomized controlled trial of women reporting childbirth related fear during~     pregnancy. One arm will receive SC and one arm ICBT though the U-CARE platform. Follow up of~     given treatment will occur at 30 and 36 weeks of pregnancy, two months and one year after~     birth. Intervention: The intervention will focus on management of childbirth related fear.~     This means that the participants do weekly sessions and homework assignments during~     pregnancy.~      Primary outcome will be level of childbirth related fear measured at 36 weeks of pregnancy.~      Secondary outcomes are level of childbirth related fear at 2 months and one year after birth,~     preferences for mode of birth, request for elective cesarean section, compliance and~     satisfaction with treatment and costs.~      Expected benefits: This study will contribute to the development of new treatment methods for~     childbirth related fear. Evidence of the best treatment to reduce childbirth related fear~     based on the results from this study could be implemented in clinical practice and hopefully~     decreases the numbers of cesarean sections without medical indications.~   "
96319|NCT02306421|"~     Simplified Milligan-Morgan is a surgical option which was improved and developed by Professor~     He,well-known traditional Chinese doctor from Hunan province,based on Milligan-Morgan.RPH is~     a new therapy for hemorrhoid following the improvement of rubber band ligation.RPH~     +Simplified Milligan-Morgan is one of important means of modern surgery.The operation method~     was improved and developed on the basis of Chinese medicine traditional loop ligature and it~     also embodies uniqueness and advantage of the treatment of mixed hemorrhoids combined~     traditional Chinese and Western Medicine.The study intends to compare five surgery ways~     through 3000 cases of patients with mixed hemorrhoid from 12 hospitals,observing the efficacy~     and safety of various operative methods.Exploration of RPH + Simplified Milligan-Morgan~     operation indication, contraindication, operation steps and key points, and the operation~     complications and sequelae and treatment etc provide evidence of evidence-based medicine for~     Clinical application.~   "
96320|NCT02306395|"~     The purpose of this study is to determine whether edometrial local injury improves the~     outcome of embryo transfer,and to find out more evidence about the time of trauma,the way of~     intervention,and the possible mechanism.~   "
96321|NCT02306382|"~     Drainage of perianal abscesses is a well established treatment. Traditionally its been done~     in general anesthesia after the swelling has been localised its been drained with a knife.~     After surgical intervention complications can occur with recidivism, chronic fistulas that go~     from the anal to the skin and sometimes the anal sphincter is damaged which can cause~     problems with incontinence.~      Through ultrasound the abscess is opened under more controlled forms with a better visual~     overview. This is a new technique that has not been tested in larger studies. The aim with~     ultrasound-drainage as with traditional incision to drain the abscess so that the infected~     area can heal.~      The hypothesis is a reduction of recurrences and formation of fistulas with the use of 3D~     ultrasonography.~   "
96322|NCT02306369|"~     This randomized controlled trial aims to evaluate the treatment effects of an~     internet-delivered CBT-program for adolescents with irritable bowel syndrome.~   "
96338|NCT02306161|"~     This randomized phase III trial studies how well combination chemotherapy with or without~     ganitumab works in treating patients with newly diagnosed Ewing sarcoma that has spread to~     other parts of the body. Monoclonal antibodies, such as ganitumab, may block tumor growth in~     different ways by targeting certain cells. Drugs used in chemotherapy, such as vincristine~     sulfate, doxorubicin hydrochloride, cyclophosphamide, ifosfamide, and etoposide, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. It is not yet known whether~     combination chemotherapy is more effective with or without ganitumab in treating patients~     with newly diagnosed Ewing sarcoma.~   "
96323|NCT02306356|"~     An open trial will be conducted at the Child and Mental Health Service (CAMHS) unit in the~     rural county Jämtland in Sweden to test the feasibility and efficacy of Internet-delivered~     Cognitive Behavior Therapy (ICBT) for children with anxiety disorders in a clinical setting.~     20 children with a principal diagnosis of Generalized Anxiety Disorder (GAD), separation~     anxiety, specific phobia and their parents will be recruited from the CAMHS-center in~     Östersund. They will receive 12 weeks of therapist-supported ICBT and will be assessed by~     clinician ratings and child- and parent-reports at baseline, post-treatment and 3 month~     follow-up. The primary outcome measures the Clinical Global Impressions - Severity scale~     (CGI-S). Secondary outcome measures include clinician rated global functioning, and child and~     parent-rated anxiety and functioning.~   "
96324|NCT02306343|"~     The study is an open-label, randomized, two-period, one-way crossover study using the Meal~     Tolerance Test (MTT) protocol or the daily life setting protocol.~      The study consists of two parts. Subject may participate in both parts or just in one part.~      The first part tests the effect of local heating on the post prandial glucose levels~     following a bolus at in-patient settings.Type I and type II diabetic patients on basal bolus~     insulin therapy admitted after overnight fast for a meal tolerance test. Subjects injected~     0.2 units/kg and consumed standardized liquid meal. Blood samples for glucose and insulin~     measurements was taken from a venous line. The study was conducted twice with (test) and~     without (control) the use of the InsuPad device.~      The second part evaluate the safety and efficacy of the device use at daily life settings.~     Type I and type II diabetic patients enrolled to the study. They will be required to perform~     at least 3 self monitored blood glucose (SMBG) measurements. Study length is up to 25 months.~     Up to one month run in period, up to 12 months with the device (test) and up to 12 months~     without the device (control).The subjects will be asked to record events of hypoglycemia,~     hyperglycemia and any adverse events related to diabetes or the study.~   "
96325|NCT02306330|"~     MALDI-TOF MS is capable of directly identifying bacteria and fungi in positive blood~     cultures, which may be beneficial to patient management. Therefore, MALDI-TOF MS is an~     important new technology that is becoming routine in developed countries. It is currently~     unknown whether MALDITOF MS improves diagnostics, costs and patient outcomes in developing~     countries. This study will assess the clinical impact of a MALDITOF MS system (Maldi~     Biotyper, Bruker, Germany) in the resource constrained setting of Vietnam and at what cost.~   "
96326|NCT02306317|"~     The purpose of this study is to determine whether saturation control by parents in children~     younger than 32 weeks or under 1500 g versus conventional care performed by nursing increases~     the time in which these patients remain at optimal saturation range. If the hypothesis of~     this study is confirmed premature infants could prevent episodes of hypoxia-hyperoxia and~     also give more relevance to the role of parents in caring for their children admitted in a~     neonatal intensive care unit.~   "
96327|NCT02306304|"~     The study aims at screening Israeli Arab men, smokers or past smokers, for abdominal aortic~     aneurysms (AAA).~      The screening is to be performed at the family doctors clinics in the rural arab erea of the~     north of Israel.~      Goals:~      The investigators aim at revealing the actual prevalence of AAA in the Israeli Arab smoking~     men population. By revealing this prevalence we believe the need for a nation-wide screening~     program for AAA will turn available for assessment.~      In addition, the goal of improving the accessibility of health services for the Israeli Arab~     population is a key issue in the design of the research.~      2000 patients are to be enrolled in the study over a period of 2 years. Each of the patients~     will be examined once for a duplex ultra-sound and will be classified into one of 4~     sub-groups according to the maximal aortic diameter found.~   "
96328|NCT02306291|"~     This study will evaluate GMI-1271, a specific E-selectin antagonist, in acute myeloid~     leukemia in combination with standard agents used to treat this disease.~   "
96329|NCT02306278|"~     The study is to observe the effects of gabapentin premedication on postoperative~     pain,vomiting and nausea in patients undergoing neurosurgery. 100 neurosurgical patients are~     randomized into groups gabapentin(GG) or placebo(GP). Patients are given gabapentin or~     placebo orally the night before operation day and 2hours before surgery,respectively.The~     investigators hypothesized that lower incidence of postoperative pain,vomiting and nausea be~     observed in GG than GP.~   "
96330|NCT02306265|"~     The aim of this recruitment plan (ADAPT-SCR) is to collect image and other data on both~     digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM) from~     asymptomatic women undergoing screening mammography. These data will be included in a~     subsequent and prospectively planned pooled analysis described in a separate protocol~     (ADAPT-BIE) examining superiority of DBT to FFDM for breast cancer diagnosis and other~     clinical performance measures.~   "
96331|NCT02306252|"~     The CARE Program is a randomized trial of a cancer rehabilitation program designed to help~     older cancer patients who have shown to have a loss of function.~   "
96332|NCT02306239|"~     Terlipressin becomes a vasopressin for septic shock. But some studies found it may lead to~     severe intesitnal complications such as intestinal ischemia. The investigators study was~     designed to find the effect of terlipressin on intestinal function in septic shock patients.~   "
96333|NCT02306226|"~     Post-market registry aimed at further evaluating the safety and performance of the ACURATE~     neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System in patients with~     severe aortic stenosis treated with the commercialized device~   "
96334|NCT02306213|"~     Recent studies have shown an increased incidence of renal replacement therapy after the use~     of Hydroxyethylstarchs (HES) in patients admitted in the intensive care unit. However,~     studies showing detrimental effects of HES have been conducted in mostly non-surgical~     subjects. There are very few studies analyzing the effects of HES on renal function after~     cardiac surgery, a population already at risk of renal dysfunction.~   "
96335|NCT02306200|"~     The goal of this project is to establish a biobank of clinical information, DNA, plasma, and~     aortic tissue samples from patients with cardiovascular disease as well as healthy controls.~   "
96336|NCT02306187|"~     In the patients with osteoporosis, bisphosphonates (BPs) are a golden standard treatment.~     However, the bone turnover markers or the bone mineral density (BMD) are not improved in some~     osteoporotic patients even though they have taken BPs and alfacalcidol more than several~     years. In those case, the investigators better off prescribing BPs and Eldecalcitol, instead~     of BPs and Alfacalcitol.~   "
96340|NCT02306135|"~     mTOR kinase is part of the mTORC1 complex that promotes cap-dependent protein translation,~     and part of the mTORC2 complex that activates AKT. Everolimus (Afinitor) is an allosteric~     inhibitor of mTOR that suppresses mTORC1 activity. Everolimus is FDA-approved for the~     treatment of ER+/HER2- breast cancer (in combination with exemestane), renal cell carcinoma,~     subependymal giant cell astrocytoma (SEGA), and neuroendocrine tumors of pancreatic origin~     (PNET), and is currently being tested in ongoing clinical studies in other indications. While~     everolimus-based therapies elicit anti-cancer effects, most cancers ultimately progress and~     exhibit everolimus resistance. This study will evaluate genetic mechanisms of resistance to~     everolimus.~   "
96341|NCT02306122|"~     This study is a pilot test of an intervention that delivers timely diagnostic information~     about medication nonadherence to doctors, and then offers the services of clinical~     pharmacists to treat these nonadherence problems. Participating doctors will be notified when~     a patient is 10 days late refilling a medication for diabetes, hypertension, or~     hypercholesterolemia. In one randomization arm the pharmacist will contact the patient as the~     default option (with no action required by the doctor), and in the other the pharmacist will~     contact the patient only if the doctor actively chooses that the pharmacist take action.~     Patients of participating doctors will be randomized to 1) one of these two pharmacist~     options, 2) an information only control arm in which the doctor gets adherence information~     but does not have access to a pharmacist for that patient, and 3) a no information control~     arm. The investigators' central hypothesis is that the pharmacist will be consulted more~     often when intervention by the pharmacist is the default outcome and that the default~     pharmacist intervention will be the most beneficial for adherence outcomes.~   "
96342|NCT02306109|"~     ErmoSLA is a multicentric, randomized, controlled trial to compare effects of an intensive~     or standard motor rehabilitation treatment on motor disability in people with ALS~   "
96343|NCT02306096|"~     This study evaluates the genomic profiles of breast cancer in a prospective and~     population-based manner. In the first phase, breast tumors are analyzed by whole~     transcriptome RNA-sequencing. Gene expression profiles, mutational profiles, and transcript~     isoform-level data will be analyzed in the context of patient information,~     clinicopathological variables, and outcome, with the purpose to develop new molecular~     diagnostic assays for breast cancer. Additional genome-scale RNA, DNA, and protein analyses~     will be performed in the future.~   "
96344|NCT02306083|"~     In this double blind clinical trial 92 patients suffering from rheumatoid arthritis are~     included. Those with the history of intraocular and corneal surgery, diabetic and heavy~     smokers are excluded from the study. Before starting the treatment all patients undergo~     complete ophthalmic exam, corneal biomechanical properties assessment by Ocular Response~     Analyzer (ORA) and corneal thickness measurement. Patients are randomly assigned to treatment~     and placebo groups. Those in the treatment groups receive glucosamine sulfate 1500 mg three~     times a day. Those in placebo arm receive alike capsule with the same schedule. At month 3~     and 6 IOP(intraocular pressure), ORA and pachymetry would be checked again.~   "
96345|NCT02306070|"~     This study will evaluate the role of Metformin on liver fibrosis in HCV-HIV co-infected and~     HCV mono-infected patients with insulin resistance receiving DAA HCV treatment.~   "
96346|NCT02306057|"~     This project will evaluate fluid balance and edema formation in children with congenital~     heart disease in need of a surgical procedure, The Fontan procedure. Surgery will make the~     child end up with a univentricular heart with one-chamber circulation ( Fontan circulation).~     This project will evaluate if these children has increased micro vascular leakage before~     surgery due to their congenital heart defect. The project will also investigate if the edema~     formation seen during cardiac surgery with the use of Cardio-Pulmonary Bypass (CPB) and~     hypothermia is caused by capillary leakage of plasma protein.~      The study hypothesis are~        1. Edema developed during heart surgery is caused by reduced colloid osmotic pressure~          gradient through the capillary membrane.~        2. The degree of micro vascular leakage in open-heart surgery is related to duration of CPB~          and hypothermia.~        3. Fontan circulation cause peripheral edema related to elevated central venous pressure~          and is not caused by increased micro vascular leakage of plasma proteins.~   "
96347|NCT02306044|"~     The purpose of the study is to investigate whether platelet indices from automated~     haematology equipment, whole blood impedance aggregometry and a standardized bleeding~     questionnaire predict bleeding in admitted patients with thrombocytopenia of various causes.~   "
96348|NCT02306031|"~     Eyes of 108 diabetic patients have underwent phacoemulsification and intraocular lens~     implantation surgery have enrolled. Fifty four eyes have received the conventional~     postoperative care with steroid drop, whereas the other group (54 eyes) have given a~     preoperative diclofenac drop four times daily in addition to steroid drop and continued six~     weeks after surgery. All patients have evaluated by Optical coherence tomography (OCT)~     preoperatively and days 1, 30, and 90.The outcome measures including best corrected visual~     acuity (BCVA) and OCT findings were compared in and between both groups.~   "
96349|NCT02306018|"~     The investigators are trying to evaluate the agreement of cardiac output measurements taken~     using the specific thermistor-tipped arterial catheter ( the VolumeView ™ catheter) and the~     EV1000 ™ monitoring platform ( Edward lifesciences, Irvine, CA, USA) with measurements taken~     using continuous pulmonary artery thermodilution cardiac output monitoring during orthotopic~     liver transplantation.~   "
96369|NCT02305758|"~     This study seeks to evaluate the efficacy and tolerability of veliparib in combination with~     FOLFIRI +/- bevacizumab in previously untreated, metastatic adenocarcinoma of the colon or~     rectum. FOLFIRI is a chemotherapy regimen of fluorouracil, leucovorin and irinotecan.~      This is a blinded study such that the Investigator and Subject will be blinded but AbbVie~     will be unblinded.~   "
96370|NCT02305745|"~     Evaluating the long term cardiovascular risks of those mothers who have been diagnosed with~     preeclampsia in pregnancy.~   "
96385|NCT02305550|"~     Study Design: This is a two-part physiological for a device feasibility. Both studies are~     proof of concept descriptive pilot studies.~      The FIRST PART is a study of healthy volunteers and the SECOND PART of patients with~     pulmonary hypertension at routine cardiac catheterization laboratory (CATH-LABORATORY).~      Volunteers and patients will be enrolled sequentially; there is no group randomization.~      Overall hypothesis of this device feasibility study: To test a lightweight and portable~     method of synthesizing therapeutic levels of inhaled nitric oxide from air by electrical~     pulsed discharge.~   "
96350|NCT02306005|"~     The aim of the study is to evaluate the effect of insulin therapy in patients with newly~     diagnosed type 1 diabetes on quantitative and qualitative changes of plasma lipoproteins,~     with particular emphasis on HDL metabolism, and analysis of the factors determining the~     effect of insulin therapy on lipid profile.The study is planned to cover a minimum of 100~     people with newly diagnosed type 1 diabetes and lead prospective observation of this group~     (for a minimum of 5-10 years). Patients will be assessed: during the first hospitalization in~     the moment of diagnosis (prior to introduction of insulin treatment), after 3 weeks, after 6~     months and after 12 months of insulin therapy. Further observations planned in the annual~     intervals. In addition, the study group will be under constant monitoring of metabolic~     evaluation every three months in the Outpatient Clinic.~      During each follow-up will be assessed parameters evaluating the metabolism of plasma~     lipoprotein fractions and subfractions of HDL:~        1. The concentration of apolipoprotein: including A-I, A-II, A-IV, C (II and III), D and E~        2. Electrophoresis of plasma lipoproteins~        3. Electrophoresis of HDL~        4. The activity of enzymes: acyltransferase lecithin: cholesterol (LCAT) and plasma~          lipoprotein lipase Moreover, evaluation of factors which may potentially modify the~          relation between insulin therapy and lipoproteins will be assessed~             1. Anthropometric data and markers of insulin resistance (such as BMI, waist-hip~               ratio, the estimated rate of glucose distribution, VAI index, body fat, blood~               pressure),~             2. Metabolic management of diabetes,,~             3. Protein glycation end products~             4. The concentration of plasma adipokines.~      Expected impact of the research project on the development of science, civilization and~     society The obtained results allow to assess the impact of exogenous insulin on quantitative~     and qualitative changes and metabolism of lipoproteins in the serum of patients with type 1~     diabetes. Understanding the etiopathogenesis of this phenomenon and the factors affecting it~     seem to be very important in the treatment of patients with type 1 diabetes, where insulin is~     the treatment of choice and dosage adjustment appears to be extremely important. Remains~     unknown whether the changes in the lipoprotein profile result from the beginning of insulin~     therapy or other factors influence it. Selecting a group of patients with less favorable~     lipoprotein profile may allow better metabolic control, and thus will affect the quality and~     length of life of our patients. These studies will assess the impact of our therapeutic~     actions on the diagnosis of the disease on long-term consequences, such as the development of~     chronic complications.~   "
96351|NCT02305992|"~     Once kidney function goes below 10 to 15 percent of normal, dialysis treatments or a kidney~     transplant are necessary to sustain life. One type of dialysis is hemodialysis which cleans~     blood by removing it from the body and passing it through a dialyzer, or artificial kidney.~     To maximize the amount of blood cleansed during hemodialysis treatments, there should be~     continuous high volumes of blood flow. A fistula used for hemodialysis is a direct connection~     of an artery to a vein. Once an arteriovenous fistula (AVF) is created it is a natural part~     of the body. This is the preferred type of access because once the fistula properly matures~     and gets bigger and stronger; it provides an access with good blood flow that can last for~     decades. After the fistula is surgically created, it can take weeks to months before the~     fistula matures and is ready to be used for hemodialysis. There have been surgical factors~     identified; one of them being the anesthetic used which may cause a fistula not to survive.~     This study will look at comparing 3 anesthetic techniques: axillary block (AB) versus~     stellate ganglion (SGB) block+local anesthetic versus local anesthetic (LA).~   "
96352|NCT02305979|"~     The purpose of this project is to assess the efficacy of loratadine in decreasing the~     incidence and severity of bone pain following G-CSF administration in patients with~     hematologic malignancies, patients undergoing mobilization of hematopoietic progenitor cells,~     and patients who have undergone an autologous hematopoietic cell transplant. This is a~     different patient population than those being assessed in current clinical trials.~   "
96353|NCT02305966|"~     Reverse total shoulder replacement surgery (RTSA) is performed for individuals with advanced~     arthritis of the shoulder who also have tears in their rotator cuff muscles. A metal~     hemisphere is placed in the shoulder blade, and a plastic cup on a stem is placed in the~     upper arm. This orientation is opposite to the normal anatomy, giving rise to the term~     reverse shoulder replacement. While RTSA has a good clinical track record, no studies have~     examined how well fixed the implanted components are within patients.~   "
96354|NCT02305953|"~     Psoriasis is an inflammatory disease involving the skin, the joints and the vascular~     compartment. The mechanisms linking inflammation in the skin and joints and in the vascular~     walls are poorly understood. One hypothesis for the increase in vascular inflammation~     observed in patients with psoriasis involves circulating pro-inflammatory cytokines. Patients~     with psoriasis have an increase in serum levels of tumor necrosis factor alpha (TNF-alpha),~     Interleukin-17 (IL-17), IL-22, IL-6 as well as a the chemokine S100A913. It is possible that~     one of those cytokines/chemokine induces vascular inflammation in the vascular compartment.~     The purpose of this cross sectional retrospective study is to highlight the correlation~     between vascular wall inflammation using 18F-2-fluoro-2-deoxy-D-glucose - Positron Emission~     Tomography (FDG-PET) fluorodeoxyglucose technology and pro-inflammatory cytokines/chemokine.~   "
96355|NCT02305940|"~     This study investigates if long term use of the antibiotic doxycycline can reduce~     exacerbations in COPD patients. Half of the patients will receive doxycycline which the other~     half will receive a placebo.~   "
96356|NCT02305927|"~     The purpose of this study to assess the effect of maternal vitamin D3 (cholecalciferol)~     supplementation on maternal HIV progression, small-for-gestational age infants, and infant~     stunting at 12 months postpartum for HIV-infected Tanzanian pregnant women who are receiving~     highly active antiretroviral therapy (HAART).~   "
96357|NCT02305914|"~     This is a follow-up study focusing on long-term complications of acute pancreatitis. The~     primary purposes include: 1. To assess the incidence of type 2 diabetes~     mellitus（2-DM）,impaired glucose tolerance, metabolic abnormalities of blood lipids after~     acute pancreatitis. 2. To observe the possible long-term clinical outcomes after acute~     pancreatitis attack, which may include: chronic pancreatitis, pancreatic cancer,~     pancreatogenic portal hypertension, autoimmune pancreatitis et al. 3. To evaluate the~     long-term influence of acute lung injury(PaO2/FiO2<200,FiO2 means fraction of inspiration O2)~     in AP patients during ICU stay on life qualities of the patients; 4. To observe the prognosis~     of the local complications of acute pancreatitis(AP) patients; it might be helpful to find~     the most effective and targeted interventions aiming at different phases after AP attack.~   "
96358|NCT02305901|"~     To assess the influence of BI 187004 on pharmacokinetics of CYP2C8 and CYP2B6 probe drugs~     repaglinide and bupropion as a means of predicting drug-drug interactions.~   "
96359|NCT02305888|"~     The objective of the trial is to investigate the Safety of LEO 43204 0.018%, 0.037% and 0.1%~     for actinic keratosis applied once daily for three consecutive days on face/chest, scalp and~     trunk/extremities, respectively.~   "
96384|NCT02305563|"~     The purpose of this study is to determine the safety and effectiveness of ulocuplumab in~     combination with low dose cytarabine in the treatment of Newly Diagnosed Acute Myeloid~     Leukemia (AML).~   "
96397|NCT02305394|"~     Electroconvulsive therapy (ECT) is an effective treatment for depression compared with the~     current antidepressant agents，but the most important side effect is cognitive dysfunction.~     The purpose of this study is to determine whether subanesthetic dose of ketamine combined~     with propofol is superior to propofol anesthesia alone in improving cognitive function in~     depressive patients undergoing ECT.~   "
96360|NCT02305875|"~     The investigators have made a favourable experience with the in 2006 published transarterial~     triple injection method [4]. This classic method combines the block effect of an axillary~     catheter injection (median nerve position) with a double transarterial injection at terminal~     nerve level in the axilla.~      The investigators experience after a recent published MRI study [3], confirms that a proximal~     axillary local anesthetic injection via an axillary catheter, guided by nerve stimulator, is~     beneficial for the block effect. The MRI study was conducted using nerve stimulation and a~     transarterial technique. The proximal injection with an effect at cord level, combined with~     axillary injections at terminal nerve level, produce an effective block distal to the elbow.~      The proximal injection has obviously an effect to the lateral cord and the musculocutaneous~     nerve (mcn) [3]. Recent studies have advocated that a double axillary injection method is~     sufficient for the axillary block [5, 6]. Their block techniques included a selective block~     of the mcn at terminal nerve level. The investigators MRI study [3] demonstrated a successful~     block effect (analgesia or anaesthesia) of the mcn nerve in all patients (15 of 15 patients)~     in the triple injection group without a selective block of this nerve. In the 1- deposit~     (catheter injection) and 2-deposit (transarterial injections) group, 11 of 15 patients (73%)~     had the mcn successful blocked.~      The objective in this study (Article 4) is to examine the mean position of the mcn nerve and~     its relationship to the coracobrachial muscle. Can MRI indicate / predict that a proximal~     directed axillary catheter in median nerve position is beneficial in order to provide a~     successful mcn blockade? Is a selective injection to the mcn at terminal nerve level~     superfluous when a catheter is used?~   "
96361|NCT02305862|"~     The aim of this study is to assess whether high intensive statin therapy could regress~     carotid atherosclerotic plaques as determined by High-Resolution Contrast Enhanced Magnetic~     Resonance imaging (CE-MRI).~      Enrolled patients have a baseline CE-MRI examination for screening carotid atherosclerotic~     plaques and are randomized to either low dose of Rosuvastatin (5mg) group or high dose of~     Rosuvastatin (20mg) group. After 26 weeks, all patients received CE-MRI examination again and~     each pair of baseline and follow-up CE-MRI assessments was analyzed in a blinded fashion.~     Moreover, lipid level and major adverse cardiovascular events are also evaluated during~     follow-up.~   "
96362|NCT02305849|"~     The objective of this study is to verify the efficacy of ASP015K versus placebo administrated~     in combination with methotrexate (MTX) over placebo in terms of efficacy in patients with~     rheumatoid arthritis (RA) who had an inadequate response to MTX~   "
96363|NCT02305836|"~     A prospective randomized controlled trial aimed at assessing if electroacupuncture (EA)~     combined with donepezil is more effective than donepezil for improving the cognitive function~     of AD patients. The hypothesis of this study is as follow:~        -  Is the short-term effect of EA combined with donepezil better than donepezil on~          improving cognitive function of patients with Alzheimer's disease after 12 weeks'~          treatment?~        -  Whether the effect of EA combined with donepezil on improving cognitive function can~          last until the end of 6 months' follow-up?~   "
96364|NCT02305823|"~     The selection of antipsychotic in early stages of the illness is mainly determined by its~     clinical effectiveness. Second generation antipsychotics (SGAs) are the first line drug~     treatment for individuals suffering from schizophrenia. It is clear that SGAs are not a~     homogeneous group and clinical effects and profile of side effects differ between SGAs.~     Differences among antipsychotics in terms of effectiveness have turned out to be a topic of~     increasing research interest, although comparisons between the different SGAs are scarce. In~     first episode of psychosis, SGAs have shown a higher treatment effectiveness compared to~     first generation antipsychotics (FGAs) (findings primarily driven by Haloperidol). Less~     evident seems to be the notion that some of the SGAs might be more effective (in terms of~     treatment discontinuation) than others. Most of the medium-term randomized studies have shown~     similar rates of all-cause treatment discontinuation in first episode patients treated with~     different SGAs. It may be concluded that more randomized controlled trails should be~     accomplished to determine the position of frequently used SGAs in clinical practice. The~     investigators undertook this study with the major objective of comparing the clinical~     effectiveness of three widely utilized SGAs (Aripiprazole, Ziprasidone and Quetiapine) in the~     acute treatment of first-episode non-affective psychosis individuals.~   "
96365|NCT02305810|"~     Everolimus represents an approved therapy for patients with advanced well/moderately~     differentiated pancreatic NETs. Although some patients could benefit from this drug in terms~     of long-term tumor growth control, others are resistant upfront or become resistant during~     treatment. Therefore, it is crucial to detect some biological factors which can help to~     identify the responsive tumors. Given that Everolimus is a biological agent and its mechanism~     of action can be partially directed towards angiogenesis its effects can be studied on~     different levels and with different methods. Upfront and early surrogate predictive markers~     of activity/efficacy can be studied on tumor tissue, tumor imaging, and peripheral blood.~     mTOR pathways alterations, circulating endothelial cells, and other circulating angoigenic~     factors will be correlated with clinical outcome. Tumor perfusion and circulating markers~     will be studied also as markers of response compared with the morphological imaging.~   "
96366|NCT02305797|"~     To evaluate the efficacy of EDG004 compared to placebo for the treatment of adult patients~     with GAD, diagnosed by Diagnostic and Statistical Manual of Mental Disorders, 5th Ed. (DSM-5)~     and confirmed by the Mini International Neuropsychiatric Interview (MINI 7.0). Efficacy will~     be measured by a statistically significant greater mean reduction from baseline compared to~     endpoint in anxiety symptoms as measured by the total score of the clinician-rated Hamilton~     Rating Scale for Anxiety (HAM-A) for the EDG004 treatment group compared to placebo.~   "
96367|NCT02305784|"~     YKL-40 is proposed as a biomarker of various inflammatory disease diabetes and lung disease~     including cystic fibrosis. In those cross-sectional studies, a unique value of YKL-40 is used~     to correlate with clinical, physiological, or biological determinants of disease severity~     (like FEV1 for example in lung disease). There is only one longitudinal study that showed a~     correlation between circulating levels of YKL-40 and the decline of lung function in smokers~     sampled from the general population. In order to better understand the potential role of~     YKL-40 in CF pathophysiology, and to determine its potential role as a biomarker of disease~     evolution, it is essential to proceed with further clinical evaluation. The investigators~     propose to perform an observational prospective cohort study to determine if variation of~     YKL-40 concentration over 24 months correlates with the clinical evolution of the patients.~   "
96371|NCT02305732|"~     The rationale for a Treatment Use Investigational Device Exemption (IDE) of INTERCEPT PCs is~     to address current gaps in platelet transfusion safety in selected geographic regions. The~     objective is to provide access to INTERCEPT PCs for patients who might be at risk of~     transfusion-transmitted infection (TTI) due to Chikungunya virus (CHIKV) and Dengue virus~     (DENV) in regions in which a substantial proportion of the population has been infected or is~     at risk of infection by these pathogens (Petersen 2014); and the risk of asymptomatic~     infection among qualified blood donors is recognized (Stramer 2012, Adda 2014).~      The study is designed as a prospective, open label, multi-center, observational study to~     evaluate the safety and efficacy of INTERCEPT platelet components.~   "
96372|NCT02305719|"~     Aim of the study is to evaluate different regional anesthesia regimes for thoracoscopic~     surgery to evaluate their efficiency in (postoperative) pain control.~      Three regional anesthesia forms are evaluated: thoracic epidural anesthesia,~     (ultrasound-guided) serratus-anterior-plane-block an local infiltration with local anesthetic~     at the site of performing the thoracoscopy.~   "
96373|NCT02305706|"~     Colonoscopy is technically challenging. Conventionally, colonoscopy begins with patients~     positioned in the left lateral position. However, few published studies have explored~     alternatives and there is consequently little evidence to support left lateral starting~     position over alternatives.~   "
96374|NCT02305693|"~     140 women with clomiphene resistant PCOS will be randomly divided into 2 equal groups using~     computer generated random numbers. Group 1 will receive Letrozole, group 2 will have~     laparoscopic ovarian drilling (LOD).~   "
96375|NCT02305680|"~     This study is to describe the long-term antithrombotic management patterns in a real-life~     setting for patients hospitalized with an acute coronary syndrome in China.~   "
96376|NCT02305667|"~     Introduction: Compared with the Macintosh laryngoscopy (MAC), the videolaryngoscopes (VL)~     provide superior glottis views and longer times to double-lumen tube (DLT) intubation. We~     hypothesize that the use of the King Vision™ (KVL) and the Airtraq® VLs may reduce the time~     for DLT intubation compared with the Glidescope® (GVL) and MAC in patients undergoing~     thoracic procedures.~      Methods: One hundred-forty patients who will be scheduled for elective thoracic procedures~     using the DLT for one-lung ventilation will be randomly assigned to one of four groups (n=35~     per group) to intubate using the MAC, GVL, Airtraq®, or KVL. Time to DLT intubation, glottis~     view, ease of intubation, number of optimization maneuvers, and failure to intubation (>150~     s.) will be recorded.~   "
96377|NCT02305654|"~     This is an international phase III trial, with a Bayesian design, incorporating two~     sequential randomisations. It efficiently examines a series of questions that routinely arise~     in the sequencing of treatment. The study design has evolved from lengthy international~     consultation that has enabled us to build consensus over which questions arise from current~     knowledge and practice. It will enable potential randomisation for the majority of patients~     with inguinal lymph node metastases and will provide data to inform future clinical~     decisions.~      InPACT-neoadjuvant patients are stratified by disease burden as assessed by radiological~     criteria. Treatment options are then defined according to the disease burden strata.~     Treatment is allocated by randomisation. Patients may be allocated to one of three initial~     treatments:~      A. standard surgery (ILND); B. neoadjuvant chemotherapy followed by standard surgery (ILND);~     or C. neoadjuvant chemoradiotherapy followed by standard surgery (ILND).~      After ILND, patients are defined as being at low or high risk of recurrence based on~     histological interpretation of the ILND specimen. Patients at high risk of relapse are~     eligible for InPACT-pelvis, where they are randomised to either:~      P. prophylactic PLND Q. no prophylactic PLND~   "
96378|NCT02305641|"~     This is a phase IV, prospective, multicenter, non-interventional study (regulatory~     post-marketing surveillance) in approximately 3,000 patients who are to receive Kadcyla~     (trastuzumab emtansine). Patients with HER2-positive, unresectable locally advanced or~     metastatic breast cancer, who have received prior treatment with trastuzumab and a taxane,~     and administered Kadcyla infusion at physician's discretion will be registered for this~     surveillance in Korea. Patients will be asked to provide informed consent; data will be~     collected by electronic Case Report Forms for approximately 6 years.~   "
96379|NCT02305628|"~     This is a phase IV, prospective, multicenter, observational study (regulatory post-marketing~     surveillance) in approximately 600 patients who are to receive Herceptin SC (trastuzumab,~     subcutaneous administration) per approved local labeling. Patients will be under observation~     according to standard of care in Korea.~   "
96380|NCT02305615|"~     This prospective, multicenter, observational study will investigate the effectiveness and~     safety of bevacizumab in routine clinical practice in participants with metastatic CRC.~     Participants are to have initiated first-line treatment with fluoropyrimidine-based doublet~     chemotherapy plus bevacizumab according to the bevacizumab Summary of Product Characteristics~     (SmPC).~   "
96381|NCT02305602|"~     This Phase I, open label, study will investigate the effects of VentriGel injection in~     patients who have experienced a first, large ST elevation myocardial infarction (STEMI)~     treated by PCI within the past 3 years and have evidence of left ventricular remodeling.~   "
96382|NCT02305589|"~     This study evaluated the effect of sugammadex on postoperative delirium in elderly patients~     undergoing hip fracture surgery.~      Medical records from 235 consecutive patients undergoing hip fracture surgery were~     retrospectively reviewed and total 61 patients were excluded for age under 60 years,~     preoperative neurologic problem. Finally total 174 patients aged over 60 years undergoing hip~     fracture surgery with general anaesthesia using a neuromuscular blocking agent from 2012 to~     2014 at a university hospital were analyzed to compare perioperative incidence of~     postoperative delirium, pulmonary complications, intensive care unit (ICU) admission, and ICU~     and hospital stay duration and laboratory findings between patients treated with sugammadex~     (S group) and conventional cholinesterase inhibitors (C group).~   "
96383|NCT02305576|"~     The Analgesia Nociception Index (ANI) is a new unitless marker derived from Heart Rate~     Variability spectral analysis, ranging between 0 and 100 and expressing the parasympathetic~     tone. The ANI is proposed as surrogate marker for the analgesia nociception balance. However,~     many perioperative factors such as medications, position, maneuvers may influence the ANI~     values and may lead to misinterpretation. Moreover the ability of the ANI to guide opioid~     dosing has never been tested. Therefore, the aim of our study is to collect in a database all~     the perioperative factors and to study their influence on the ANI.~   "
96386|NCT02305537|"~     The collection of patient self-report and diagnostic data will allow us to examine the~     efficacy of the treatment delivered in the McLean Anxiety Mastery Program. Using data~     gathered through routine clinical care, the investigators seek to explore whether patients in~     treatment show improvements from admission to discharge, compared to patients on the~     waitlist, and whether these gains are maintained three months post-discharge. The following~     are included as examples of some of the study's hypotheses.~   "
96387|NCT02305524|"~     The objective of this study is to compared effectiveness of intubation using ETView VivaSight~     SL and standard tracheal tube during resuscitation performed by a EMS-paramedics.~   "
96388|NCT02305511|"~     The purpose of this study was to compare the Jamshidi, the BIG, the Cook, the EZIO~     intraosseous devices to standard peripheral venous catheterization during pediatric~     resuscitation.~   "
96389|NCT02305498|"~     Previous research suggests that regular physical activity may make cancer survivors do better~     in the long run. Laboratory studies suggest that stress may be bad for cancer patients as~     well. The investigators are interested in whether yoga, a practice that combines physical~     activity and stress reduction, is beneficial to cancer survivors. To answer that question,~     the investigators will need to do a large scale clinical trial.~      Before the investigators can do that large study, they need to know whether people are~     willing to participate in this kind of study, whether they can do the yoga practice regularly~     and for how long, what kind of changes they may experience in how they can handle their daily~     activities, emotion, sleep, memory and problem solving ability, and what are the changes that~     can happen in their body after doing the yoga practice. Answering these questions is what~     this study is about.~   "
96390|NCT02305485|"~     The NeoVas Bioresorbable Coronary Scaffold Randomized Controlled Trial is a prospective,~     multi-center, randomized trial. The study compares NeoVas sirolimus-eluting bioresorbable~     coronary scaffold with XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) to~     evaluate the safety and efficacy of NeoVas in the treatment of patients with de novo coronary~     lesion.~   "
96391|NCT02305472|"~     The NeoVas Bioresorbable Coronary Scaffold Registry Trial is a prospective, multi-center,~     single arm registry trial based on the NeoVas FIM study which verified the safety and~     effectiveness of NeoVas initially. This study is to evaluate the safety and effectiveness of~     NeoVas sirolimus-eluting bioresorbable coronary scaffold in the treatment of patients with de~     novo coronary lesion.~   "
96392|NCT02305459|"~     The administration of SIR-Spheres microspheres (yttrium-90 resin microspheres) is a form of~     selective internal radiation therapy (SIRT) for the treatment of patients with primary and~     secondary liver tumours. The CIRT Registry has two major objectives: 1) To collect robust~     data on the real-life clinical practice of radioembolisation with SIR-Spheres microspheres in~     a pan-European context, and 2) to collect data on the Quality of Life of patients treated~     with SIR-Spheres microspheres.~   "
96393|NCT02305446|"~     The purpose of this trial is to assess the safety of a Meningococcal Group B Vaccine and to~     collect blood donation. Sera panel obtained from blood donations will be used as a control to~     measure the immunoresponse to the Meningococcal Group B Vaccine in other studies.~   "
96394|NCT02305433|"~     Our objective is to study the effects of 12 months' intensive home-based physiotherapy with~     12 months' follow-up in two groups of older people: 1) those with an operated hip fracture~     (60+ y), and 2) those with signs of frailty (65+ y). The primary outcome measure is duration~     of living at home. Power calculations are based on the assumption that persons assigned to~     physiotherapy will live at home for six months longer vs. those in usual care. Secondary~     outcomes are physical functioning, falls, health-related quality-of-life, use and costs of~     social and health services, and mortality.~      We will recruit 300 persons with hip fracture and 300 with signs of frailty in Eksote (South~     Karelia Social and Health Care District), Finland (population 133 000). The groups will be~     randomized separately into an intervention arm (home-based physiotherapy twice a week for 12~     months) and a control arm (usual care), resulting in 150 patients in each group.~      An assessor-physiotherapist and assessor-nurse performs measurements at the participant's~     home at baseline, and after 3, 6 and 12 months. Assessments include, among others, Fried's~     frailty criteria, Short Physical Performance Battery (SPPB), Functional Independence Measure~     (FIM), Health-related quality-of-life (HRQoL, 15-D), Mini Nutritional Assessment (MNA), Falls~     Efficacy Scale - International (FES-I), Social Provision Scale (SPS), Mini Mental State~     Examination (MMSE), and Geriatric Depression Scale-15 (GDS-15). At 24 months we collect~     register information on mortality and the usage of health care services.~      Recruitment will begin in December 2014 and last for three years. Data analyses and reporting~     will take place in 2017-20. The study is supported by the Social Insurance Institution of~     Finland.~   "
96395|NCT02305420|"~     EmbryoGen and BlastGen contain the cytokine growth factor Granulocyte-Macrophage~     Colony-Stimulating Factor (GM-CSF), which has been documented to give significant benefit to~     this difficult group of patients.~      Results showed a highly significant effect of 44% relative improvement in ongoing~     implantation rate (p=0.001) in women who have previously miscarried (Ziebe et al 2013).~      We wish to undertake a randomised Controlled trial to determine if EmbryoGen/BlastGen media~     improves pregnancy outcomes in women with recurrent implantation failure, recurrent~     miscarriage and poor embryo development when compared to standard media.~   "
96396|NCT02305407|"~     Adult patients with moyamoya disease (MMD) are reported to suffer from considerable~     impairment of executive function/attention. Although reduced cerebrovascular reserve (CVR) in~     frontal areas has been detected by perfusion MRI and then confirmed to be associated with~     executive dysfunction in adult MMD, the structural and functional changes is still unclear~     with progression of executive dysfunction. Furthermore, it is very important to study the~     association between the neurocognitive and radiological improvement after surgical~     revascularization, so as to help detecting cerebral regions which are involved in executive~     deterioration or improvement after surgery. Then the investigators can determine whether~     these regions can be used as indicators to decide rational therapeutic schedule and timing of~     adult MMD with executive dysfunction.~      Thus the aim of this study is to primarily find out the neuropsychological and radiological~     correlates in adult MMD, and then to quantitatively evaluate the effectiveness of surgical~     revascularization in prevention of executive dysfunction in adult MMD.~   "
96399|NCT02305368|"~     In patients with colonic adenocarcinoma stage 4 which are potentially resectable metastases~     (lung and liver metastases), treatment with chemotherapy is necessary but not end in success~     in 10% of cases. The development of techniques for administering personalized treatment~     becomes necessary for these patients. Thus, in vitro tests on cells from tumors of these~     patients and evaluating the effect of chemotherapy on these could be made for each patient.~     In France, the company develops Oncomedics these tests.~      This is a pilot study that will make a first evaluation under actual conditions of~     chimio-oncogramme.~   "
96400|NCT02305355|"~     Assess efficacy and safety of Omacor® 4g with statin treatment for lowering TG levels in~     subjects with type 2 Diabetes combined with hyperlipidemia~   "
96401|NCT02305342|"~     This study is aiming to evaluate the sensitivity of uropathogens isolated in patients with~     community acquired UTI with Enoxacin in comparison to other antimicrobials. While Secondary~     objective is to study the spectrum of uropathogens responsible for community acquired UTI in~     local population~   "
96402|NCT02305329|"~     Single-centre, open-label, randomized, two-sequence, two-way crossover study. The study~     consisted of two consecutive single-dose treatment periods separated by a washout period of~     10 to 14 days or more.~   "
96403|NCT02305316|"~     Single-centre, open-label, randomised, two-way crossover study in 28 healthy volunteers. The~     study consisted of two consecutive single-dose treatment periods separated by a washout~     period of 14 days or more.~   "
96404|NCT02305303|"~     Treatment of severe trauma patients includes intensive cares. Both trauma and intensive care~     may lead to a post-traumatic stress disorder‬ and then to a decreased quality of life.~     Diaries may improve the frequency and the intensity of PTSD. Aim of investigator is to assess~     if diaries may improve quality of life after a severe trauma.~   "
96405|NCT02305290|"~     The purpose of this study is to evaluate the long-term outcomes of Endoscopic Resection (ER)~     of superficial lesions of the Upper Gastrointestinal Tract(UGIT)~   "
96406|NCT02305277|"~     Single-centre, open-label, randomised, three-part, two-way crossover study in 84 healthy~     volunteers. In each part, the study consisted of two consecutive single-dose treatment~     periods separated by a washout period of at least 14 days.~   "
96407|NCT02305264|"~     In this study we plan to image the compartmentalized inflammation in MS using molecular~     imaging by positron emission tomography (PET) with a very highly resolutive camera. Two~     tracers will be studied and compared: i) [18F]DPA-714, which bind to the peripheral~     benzodiazepine receptor (PBR), a target mainly expressed by activated microglial cells. This~     new ligand for PBR displays several advantages compared to the existing reference compound~     PK11195 in term of brain entrance, signal to noise ratio, and radiolabelling possibility with~     [18F] ii) [18F]-fluoro-desoxy-glucose ([18F]FDG), which should reflect glucose metabolism in~     activated immune cells in the white matter. Progressive MS patients (secondary progressive~     and primary progressive) will be compared to relapsing-remitting patients and to healthy~     volunteers. All subjects will pass a complete neurological evaluation and a multimodal MRI to~     document clinical disability and tissue injury. A clinical and radiological follow up will~     then be performed for a 2-year period. This study should help to understand the contribution~     of the intracerebral inflammation on the progression of disability and could provide a~     surrogate marker for further therapeutic trials in chronic progressive MS.~   "
96408|NCT02305251|"~     The investigators conducted a study Resect and Discard Diminutive Polyps: a new paradigm~     (IRB ID # 201105473) from September, 2011 to July, 2013. This study examined whether doctors~     performing colonoscopy are accurate enough at predicting histology of small colorectal~     polyps, such that these small polyps could be resected and discarded (instead of being sent~     to pathology). One of the main advantages of this approach is significant cost savings by~     reducing pathology costs associated with screening and surveillance colonoscopy. A~     disadvantage is that there is a 0.03% chance that small polyps contain cancer. There is no~     data regarding patient preferences toward this approach. The investigators therefore designed~     a patient survey to determine the patient's view toward this approach.~   "
96409|NCT02305238|"~     To assess the efficacy of intravitreal (IVT) administration of aflibercept with two different~     approaches of Treat and Extend dosing regimens in Japanese subjects with neovascular (wet)~     Age-related Macular Degeneration (wAMD) .~      To assess the safety of IVT administration of aflibercept with two different approaches of~     Treat and Extend dosing regimen in Japanese subjects with wAMD for up to 2 years.~   "
96410|NCT02305225|"~     The investigators examine changes in decision making, vigilance and cortical excitability in~     healthy male subjects undergoing total acute sleep deprivation (40 hours) on the one hand,~     and chronic partial sleep restriction (7 nights with 5 instead of 8 hours in bed per night)~     on the other hand, in a cross over controlled manner. The investigators hypothesize that~     total sleep deprivation, as well as partial sleep restriction lead to impairments in decision~     making and vigilance, and enhanced cortical excitability.~      Beside these three primary outcomes, the investigators also assess changes in sleep by EEG,~     dim light melatonin onset, skin temperature, subjective mood and sleepiness, working memory,~     and also collect saliva samples.~   "
96411|NCT02305212|"~     This study will examine a cognitive rehabilitation protocol targeted at working memory~     deficits for adults and children with Traumatic Brain Injury (TBI). In this randomized~     clinical trial, the efficacy of Cogmed, a cognitive rehabilitation protocol designed to~     improve working memory, will be examined in children with TBI. Neuropsychological and daily~     life functioning will be measured. Participants will be children (N=20) and adults (N=20)~     with a documented history of TBI. Participants will be randomized to a treatment group or a~     wait list control group. The Experimental Group will receive the Cogmed working memory~     training program 30-40 minutes per day, 5 days a week for 5 weeks for a total training time~     of approximately 15 hours. The Control Group will be a wait list control group that will~     cross over into treatment after the follow-up assessment. All subjects will undergo repeat~     assessments following completion of the working memory training protocol after the 7th week~     and again at 13 weeks to document changes in working memory performance.~   "
96412|NCT02305199|"~     The purpose of this study is to determine whether perioperative use of Hartmann's solution in~     type II diabetes patients increases blood glucose level after surgery. The investigators~     expect the result to broaden the choice of fluid for diabetic patients and hopefully to~     diminish the side effects manifested by the excess use of normal saline.~   "
96413|NCT02305186|"~     The purpose of this clinical trial is to study an experimental drug called pembrolizumab or~     MK-3475 for use in combination with chemotherapy and radiation therapy for patients with~     resectable (surgical removal) or borderline resectable pancreatic cancer. In general,~     pancreatic cancer that cannot be removed by surgery is sometimes treated with chemotherapy~     and radiation therapy, called neoadjuvant treatment, to shrink the tumor so that surgery~     might be possible. However, this is not always effective at shrinking the tumor enough to~     allow it to be removed with surgery. Recent discoveries suggest that the investigators own~     immune system might have a role in controlling the growth of tumors. Drugs such as~     pembrolizumab can stimulate the immune system against cancer. The purpose of this study is to~     investigate whether pembrolizumab can be used safely during neoadjuvant treatment and can~     improve the body's immune response against pancreatic cancer.~      Pembrolizumab has been approved for treatment of patients with melanoma but has not been~     proven to be safe or helpful in patients with pancreatic cancer and is not approved by the~     U.S. Food and Drug Administration (FDA) for this purpose.~   "
96414|NCT02305173|"~     Preoperative dexamethasone reduces symptoms after different surgical procedures including~     mastectomy in breast cancer, but the effect in the postoperative respiratory function remains~     unknown. The aim of this protocol was to determine if the administration of a single dose of~     dexamethasone during the preoperative, could improve respiratory function and postoperative~     symptoms of patients undergoing mastectomy in breast cancer.~   "
96415|NCT02305160|"~     The purpose of this study is to determine the efficacy and safety of the new pulmonary~     surfactant produced by Butantan Institute among premature infants with gestational age below~     34 weeks with RDS, comparing to the pulmonary surfactants commercially available in Brazil.~   "
96416|NCT02305147|"~     Observational, prospective, monocentric study to assess clinical features, imaging and~     biologic biomarkers in Parkinson disease (PD) patients and rate of progression compared to~     healthy controls (HC) and subjects at risk to develop PD.~      The primary objective of this study is to identify clinical, imaging and biologic markers of~     PD onset and progression for use in clinical trials of disease-modifying therapies.~   "
96417|NCT02305134|"~     Tipepidine (3-[di-2-thienylmethylene]-1-methylpiperidine) has been used solely as a~     nonnarcotic antitussive in Japan since 1959. The safety of tipepidine in children and adults~     has already been established. It is reported that tipepidine inhibits G-protein-coupled~     inwardly rectifying potassium (GIRK)-channel currents. The inhibition of GIRK channels by~     tipepidine is expected to modulate the level of monoamines in the brain. We put forward the~     hypothesis that tipepidine can improve attention deficit/hyperactivity disorder (ADHD)~     symptoms by modulating monoaminergic neurotransmission through the inhibition of GIRK~     channels. The purpose of this double-blind, placebo-controlled trial is to confirm whether~     treatment with tipepidine can improve symptoms in pediatric patients with ADHD.~   "
96418|NCT02305121|"~     The aim of this project is the prospective data collection of a new device used for~     trochanteric fractures of the femur. It should be answered how the newly developed implant~     called Trochanteric Fixation Nailing with anti-rotation feature (TFNA) is performing~     clinically and radiological in terms of intra- and postoperative complications.~   "
96419|NCT02305108|"~     The study will test the efficacy of the treatment of soft tissues for osteoarthritis patients~     that are waiting for total hip arthroplasty. The fascial manipulation provides a deep~     pressure of specific points of the muscle fascia. The aims of this treatment are the improve~     of pain before the surgery and the improve of functional performance after the surgery.~   "
96420|NCT02305095|"~     The response to therapy with a fixed dose combination of isosorbide dinitrate and hydralazine~     (FDC I/H) is enhanced in African Americans with heart failure and reduced ejection fraction~     (HFrEF) when compared to similar white cohorts. This study will seek to confirm the previous~     genetic sub-study from AHeFT which suggested a functional polymorphism of guanine nucleotide~     binding protein beta polypeptide 3 subunit (GNB3), C825T in exon 10, influences the~     therapeutic efficacy of FDC I/H. This study will initiate treatment with FDC I/H in 500 self~     designated African American subjects with systolic heart failure. They will be followed for~     up to two years on therapy. Clinical outcomes (survival, heart failure hospitalizations, and~     change in quality of life) on FDC I/H will be compared by GNB3 genotype subset. The~     hypothesis to be confirmed is that subjects homozygous for the T allele (those with the GNB3~     TT genotype which is present in approximately 50% of black subjects) demonstrate enhanced~     therapeutic benefit from FDC I/H.~   "
96421|NCT02305082|"~     The implementation of an enhanced recovery pathway after giant ventral hernia repair,~     including preoperative high-dose steroid is examined prospectively and compared with a group~     of historic controls.~   "
96422|NCT02305069|"~     Obesity in humans has been shown to result in the increased release of small~     inflammatory-inducing proteins, called cytokines, from the fat cells of the body. The~     investigators are interested in the effects of these cytokines on the mechanisms that control~     muscle mass and metabolism in the obese human. Previous research from work in cells and~     animals has shown the cytokines reduce the synthesis of muscle proteins and simultaneously~     enhance their rate of breakdown, resulting in a loss of muscle mass. Furthermore, research~     suggests that the same cytokines may inhibit carbohydrate oxidation, a pivotal step in muscle~     metabolism. However, despite these potential negative consequences for skeletal muscle~     function, the effect of low-level and persistent inflammation as seen in obese humans,~     remains largely unknown.~      In the current study, the investigators plan to measure the rates of synthesis and breakdown~     of muscle proteins in conjunction with rates of carbohydrate oxidation in obese older~     participants, and compare them to rates determined in healthy non-obese individuals.~     Furthermore, participants will undergo a 12-week course of either pioglitazone, an insulin~     sensitiser often prescribed to type II diabetics, or a placebo. Pioglitazone has been shown~     previously to normalise the levels of cytokines in the blood of chronically inflamed~     individuals. By repeating after the 12-week intervention period the initial measurements~     described above, and by accurately determining the levels of the cytokines, the~     identification of the negative effects of obesity-induced inflammation in older adults on~     muscle metabolism will be determined.~   "
96423|NCT02305056|"~     The purpose of the study is to follow tumoral proteins metabolism by in vivo no radioactive~     isotopic tagging (carbon 13 and nitrogen 15).~   "
96424|NCT02305043|"~     The aim of this study is to identify biomarkers predicting response or resistance factors of~     a targeted therapy with trastuzumab in advanced gastric cancer.~   "
96427|NCT02305004|"~     To follow up the result of a quality measurement based on the results of a new routine for~     drug analysis introduced during a period of time in the intensive care unit. To ensure the~     quality of the dose regimen of routine drugs for sedation and analgesics. The aim is also to~     find out if the routine analysis can give information about if the self- intoxicated patients~     have taken drugs that were primarily not suspected.To know the serum concentrations of~     routine drugs in patients who died and will undergo autopsy.~   "
96428|NCT02304991|"~     Primary Objective: To determine if 36 months of peanut SLIT as an early intervention in~     subjects ages 1 to 4 years induces clinical desensitization. The primary outcome of this~     objective will be a statistically significant difference in challenge scores between the~     treatment group versus the placebo group during DBPCFC (Double blind placebo controlled food~     challenge) performed after 36 months of peanut SLIT (desensitization). A secondary outcome of~     this objective will be a statistically significant difference in the challenge score of the~     treatment group versus the placebo group during the DBPCFC performed 3 months after~     discontinuing therapy (tolerance). Challenge scores are measured by the amount of peanut~     protein participants are able to ingest successfully without symptoms of an allergic~     reaction. [Time Frame: Baseline, 39 months]~      Secondary Objective: To examine the change in immune parameters associated with peanut SLIT~     and the development of clinical tolerance. Through this objective, the investigators will~     seek to understand the molecular processes by which SLIT affects the immune system through~     evaluation of immune mechanisms in relationship to clinical findings of desensitization and~     tolerance. The investigators will delineate the impact of peanut SLIT on the subsequent~     cellular and humoral responses to peanut protein: 1) peanut specific IgE, IgG, and IgG4~     response, 2) peanut specific basophil activation, 3) mast cell responses through skin prick~     testing, and 4) specific T-cell cytokine responses and T regulatory cell (TReg) activation.~     The investigators anticipate that the effect of peanut SLIT will occur by induction of TRegs,~     conversion of T cells from an allergic (TH2) to a non-allergic (TH1) lymphocyte response~     (measured by cytokines, antibody levels, and skin prick test size), a change in~     peanut-specific basophil activation, or through a combination of the above.~      [Time Frame: Baseline, 39 months]~   "
96429|NCT02304978|"~     Severity of colorectal cancer (CRC) is evaluated by its local staging, locoregional and~     general ( presence of metastases , usually liver ). This is the most common cancer in France~     and, despite surgical treatment of the primary tumor, it is still subject to a high mortality~     rate due to metastatic evolution, mainly hepatic .~      There is currently no specific marker for predicting cancer, the same hardly changed , which~     would modulate the aggressive therapeutic strategy . antigen (CEA) is used in the monitoring~     of JRC made.Tissue factor (TF) is the VII tissue factor receptor. it initiates the~     coagulation cascade. it was noted as a true cell marker tumorale1 aggressiveness.~     Corroborating evidence that the way the TF plays an important role in the invasive and~     metastatic potential of CRC. First, various human cancer cell lines express the FT colic.~     Furthermore, there is a relationship between the importance of monocyte TF expression and the~     evolutionary potential of human CRC.~      The investigators hypothesize that these interest intra-platelet and plasma markers are a~     reflection of tumor angiogenic potential. And the investigators will verify the superiority~     of their preoperative levels in the CRC group compared with the control group, normalization~     of postoperative after surgical resection rates and their possible re-ascent in case of tumor~     recurrence in the CRC group.~      The levy to one month in controls allow us to verify the absence of secondary modification to~     laparotomy, the colectomy and general anesthesia.~      The investigators assume that the rate of soluble TF in peripheral blood of the holders of~     CRC patients may be a marker of invasion and aggression (i.e. prognosis).~   "
96430|NCT02304965|"~     Pilot study in patients with continuous flow left ventricular assist device (cfLVAD) to proof~     the feasibility of a specific individual training at home aimed to increase pulse pressure~     above a predefined threshold which might attenuate the loss of arterial wall thickness.~      Hypothesis:~      Increasing daily physical activity near to normal (> 10.000 steps per day) with a pre-defined~     level of pulse pressure (intensity) is a realizable and feasible approach to investigate~     changes in arterial wall thickness and cardio-respiratory capacity in cfLVAD patients.~   "
96431|NCT02304952|"~     The aim is to study the effects related to function and pain during eccentric exercise and~     surgery with radiofrequency microtenotomy as post-surgical rehabilitation, compared with only~     eccentric exercise, in patients with lateral epicondylalgia unilaterally.~   "
96432|NCT02304939|"~     CHIC study's purpose is to compare the efficiency, in terms of blood pressure stability, of~     three changeovers of norepinephrine used routinely in ICU. The three techniques are:~        -  Quick change~        -  Double pumping~        -  Smart infusion pumps~   "
96433|NCT02304926|"~     Coadministration of drugs is common in the pharmacologic treatment of dyslipidemia, with~     statins and ezetimibe generally constituting the medication of choice. By acting at different~     levels, the combination of these drugs allows the therapeutic objective to be achieved.~     However, it is not known how these drugs qualitatively affect the composition of lipoprotein~     subfractions, which differ in size and atherogenic potential. The investigators set out to~     evaluate this effect as well as their effects on inflammatory, oxidative stress and~     endothelial function parameters.~   "
96434|NCT02304913|"~     This randomized controlled trial aims to investigate hypoglossal acupuncture in comparison to~     sham acupuncture and standard medical treatment (dietary recommendations) in the treatment of~     dysgeusia in cancer patients undergoing chemotherapy.~   "
96435|NCT02304900|"~     The cataract surgery (550 000 operations per year in France) is to replace the cloudy lens~     with a refractive implant. Two colors of implants are available: white implants, filtering~     out ultraviolet and yellow implants, filtering and more blue light. No clinical data are~     available to assert the superiority of an implant according to its color and the choice is~     made according to the preference of the surgeon and / or markets.~      It is established in humans that blue light has an important role on the secretion of~     melanopsin, a key mediator of the circadian cycle. This clock regulates most neuroendocrine~     functions in the nycthémère (sleep, mood, temperature, cortisol, ..). The question of the~     impact of these neuro endocrine functions of the installation of a blue light filter into the~     eyes of patients operated thus arises.~   "
96436|NCT02304887|"~     The relationship between osteoporosis drugs and kidney damage is unclear. In this study, we~     plan to reveal relationship between osteoporosis drugs and kidney damage.~   "
96437|NCT02304874|"~     Normal body iron store value in overweight subjects is currently not described in literature.~     The comparison of this value with body iron levels in patients suffering from dysmetabolic~     iron overload syndrome (DIOS) could allow to quantify iron overload in this condition. The~     purpose of the study is to determine iron levels in healthy overweight volunteers, and to~     compare them to DIOS patients treated with phlebotomy.~   "
96438|NCT02304861|"~     Objective of this study is the comparative assessment of the beneficial impact of the Viscoat~     viscoelastic (OVD) and Visthesia OVD on endothelial cells and corneal edema following~     torsional-ip cataract extraction surgery.~      Participants will be recruited from the Cataract Service of the University Hospital of~     Alexandroupolis (UHA) in a consecutive-if-eligible basis. Eligibility criteria include~     diagnosis of senile cataract with stage 3 nuclear opalescence according to the Lens Opacities~     Classification System III (LOCS-3) grading scale. By means of a custom computer randomization~     program all participants will randomly populate two study groups according to the OVD used~     (ie. viscoat or visthesia).~   "
96439|NCT02304848|"~     The purpose of this study is to evaluate the effects of low frequency deep brain stimulation~     on subthalamic nucleus neural synchrony. Low frequency stimulation does not improve the~     cardinal motor signs of Parkinson's disease, and may be beneficial only for gait and speech.~     This study will provide insight into what the effects of low frequency stimulation are on~     neural synchrony.~   "
96440|NCT02304835|"~     This study was a national, longitudinal, prospective, observational survey, carried out in~     metropolitan France, with a sampling of 21 birth control centres.~      The aim of this study was to assess, in real life conditions, the benefit of a urinary~     semi-quantitative test (hCG Duo 5-1000) in the follow-up of medical abortion by analysing the~     concordance between qualitative results from the urinary test and quantitative values from~     the beta-hCG blood measurement.~   "
96441|NCT02304822|"~     The purpose of this study is to compare the postoperative systemic inflammatory response~     syndrome (SIRS) rates undergoing retrograde intrarenal surgery (RIRS) after multiple-,~     single-, zero-dose of ceftriaxone prophylaxis in a prospective randomized trail.~      The investigators will enroll 450 patients who are candidates for RIRS in the investigators~     study. By simple random sampling technique, patients will be assigned to three groups~     (multiple-, single-, zero-dose of ceftriaxone prophylaxis,respectively). In addition to the~     difference of usage of ciprofloxacin prophylaxis, the rest of the procedure is the same in~     all three groups.The end point of the study is the comparison of outcome of procedure~     including SIRS rate, stone free rate (SFR), operation time, length of stay,and hematuresis.~   "
96442|NCT02304809|"~     Patients with metastatic or unresectable locally advanced malignancies harboring BRAF genomic~     alterations, the biological target of vemurafenib, and who are no more amenable to curative~     treatment.~      To explore the efficacy of vemurafenib as a single agent across diverse type of tumors guided~     by the presence of identified activating molecular alterations in the vemurafenib target~     gene, per cohort.~   "
96443|NCT02304796|"~     The current pilot study will examine and compare the effectiveness of two group~     psychotherapies for mixed anxiety disorders: 1. unified cognitive-behavioral protocol,~     adapted to a group format. 2. combined cognitive-behavioral and dance/movement therapy.~      In addition, change in proposed mechanism in each therapy will be examined, along with their~     association with change in outcome measures during therapy.~   "
96444|NCT02304783|"~     Outpatients treatment with NSAI in renal colics has not been well investigated and there is~     no clear recommendations regarding this matter.~      The aim of this study is to determine if an oral NSAI treatment is beneficial in patients~     discharged for the emergency departement after the first line treatment of a renal colic~     investigating the recurrence of pain, the reconsultation rates and the admissions.~   "
96445|NCT02304770|"~     The study will examine the effect of aminolaevulinic acid (ALA) photodynamic therapy (PDT) of~     cervical precancerous lesions in women.~   "
96446|NCT02304757|"~     Postmenopausal women with differentiated thyroid cancer (DTC) taking suppressive doses of~     levothyroxine (L-T4) are thought to have accelerated bone loss and increased risk of~     osteoporosis. Therefore, the investigators try to investigate the effects of 99Tc-MDP,~     calcium containing vitamin D alone and fosamax (alendronate sodium) in postmenopausal women~     with DTC and decreased bone mineral density (BMD).~   "
96447|NCT02304744|"~     UCORBIO enrolls patients who undergo coronary angiography (for any indication). The~     investigators draw blood at the moment of insertion of the procedural arterial catheter.~      At the moment of inclusion indication, procedural details, risk factor status, medication use~     and quality of life (RAND-36 and EuroQoL) is assessed. Patients are then followed-up for the~     occurrence of major adverse cardiovascular events for 5 years. During the follow-up period~     patients receive a questionnaire every year to check for hospital admissions. The~     questionnaires at two and five years of follow-up are enriched with quality of life~     questionnaires (RAND-36 and EuroQoL).~   "
96448|NCT02304731|"~     Modern society increasingly seeks healthy life style, and regular physical activity is~     considered one of the main factors that improve the quality of life. The evidence shows that~     the aerobic physical training in controlled environments benefit various aspects of human~     health, including cognition in the elderly population. However, when exercise is performed in~     a polluted environment, the individual is subjected to grater exposure to pollutants due to~     increased ventilation (breathing).~   "
96449|NCT02304718|"~     This study evaluates the role of exercise intervention in reducing the risk of gestational~     diabetes mellitus(GDM) risk of overweight/obese(prepregnancy BMI≥24kg/m^2） Chinese pregnant~     women. Half of participants will have exercise intervention, while the other half will not.~     Both of the two group will have regular prenatal care.~   "
96450|NCT02304705|"~     The purpose of this study is to determine whether Sildenafil 20mg taken three times a day is~     effective in the treatment of Heart Failure with Reactive Pulmonary Hypertension. This is a~     double-blind, placebo controlled trial.~   "
96451|NCT02304692|"~     This study is designed to compare two different surfaces of bone anchored hearing aid~     abutments in terms of bacterial colonization, inflammatory response and skin reactions.~   "
96452|NCT02304679|"~     The primary objective of this study is to evaluate the change from baseline in the erectile~     function domain of the International Index of Erectile Function (IIEF-EF) scores in patients~     receiving 4 weekly treatments of shockwave therapy versus those receiving a sham treatment.~     The change will be evaluated at 3 months after the end of a sequence of 4 weekly treatments.~   "
96453|NCT02304666|"~     Inflammatory Bowel diseases (IBD) include Crohn's disease and ulcerative colitis. IBD's~     precise origin is unknown until now. Today, the current hypothesis of the disease~     pathogenesis is that IBD result from a dysregulated mucosal immune response to the gut~     microbial flora in genetically susceptible hosts. The intestinal homeostasis depends on~     interactions between immune and epithelial cells. Epithelial cells are the first line of~     defense, are tightly connected to the underlying gut associated lymphoid tissue and their~     alteration results in loss of tissue homeostasis.~      Vanin-1 (Vnn1 in mice, VNN1 in humans) is an epithelial pantheinase which regulates the cell~     response to stress.~      This ectoenzyme hydrolyses the vitamin B5-derivative pantetheine to provide cysteamine to~     tissues and regenerate pantothenate. Previous studies have shown that Vnn1 KO mice were more~     resistant to experimental colitis and administration of cystamine (oxidized form of~     cysteamine) restored their susceptibility to colitis. Furthermore, analysis of VNN1~     expression in IBD patients show that high VNN1 expression is associated with severe clinical~     features. Thus, analysis of VNN1 expression could represent a good prognostic marker.~      In a recent published article, we characterized among a retrospective cohort of 500 IBD~     patients and controls new SNPs (single nucleotide polymorphisms) in the VNN1 promoter and~     showed their association with IBD incidence and high VNN1 expression. This suggested that the~     VNN1gene might be a new predisposition marker of IBD.~      In mouse, Vnn1 expression is tightly regulated by activation of PPARa and PPARg transcription~     factors. Interestingly, one of the SNPs identified in patients participates to a PPARg~     binding site. Interestingly, drugs related to the family of 5-ASA which are commonly used in~     IBD, have PPARgamma agonist potential. Therefore, quantifying VNN1 levels in patients under~     5-ASA therapy might help predicting response to therapy and select patients with the highest~     benefit for this therapy.~      The purpose of this new project is to extend our initial analysis. The study will be~     prospective, monocentric and controlled. Its primary objective is to evaluate the level of~     VNN1 expression in the colonic mucosa between IBD patients and control subjects to confirm~     the correlation between high VNN1 expression and IBD. In relation with its prospective~     nature, we will also try to associate VNN1 expression level with specific endophenotypes~     (severity and/or localization of the lesions, quality of the response to therapy). Finally,~     we will screen patients for the previously identified SNPs to integrate this information in~     the interpretation of the results of expression analysis.~      This study is planned on 2 years. Two groups of patients will be constituted: one group will~     include IBD patients followed in the  Service de Gastro-entérologie du Pr Grimaud à~     l'Hôpital Nord  and the other group will constitute the control cohort including persons who~     were proposed a screening colonoscopy for familial history of colon cancer or polyps, or for~     Irritable Bowel Syndrome.~      The investigator will have to fill a questionnaire for each included patient, collecting~     information about age, sex, past medical history, taken medicine, digestive symptoms and~     colonoscopy indication.~      IBD patients will have a first set of biopsies (n = 10) and blood samples collected under~     general anesthesia during a colonoscopy planned in their IBD usual follow-up; a second set of~     similar samples will be collected within the next 12 months if an endoscopic control is~     medically justified. The control subjects will have only one set of biopsy and blood samples~     collected under general anesthesia during their colonoscopy. In the particular case of IBD~     patients who require surgery, a small piece of the resection will be collected ex-vivo on~     both healthy and pathologic areas.~      The blood sample will serve for quantification of the VNN1 seric pantheteinase activity and~     SNP's genetic study.~      The colonic biopsies will be obtained in duplicates from 5 different ileocolonic areas, one~     for histopathological analysis and the other for transcriptional analysis by qRT-PCR.~      The surgical samples will be used for transcriptional activity, tissue pantheteinase activity~     and constitution of TMA (Tissue MicroArrays) bank for immunohistochemistry.~      Expected benefits are to validate a new IBD prognostic marker for disease severity or~     potentially for evaluation of the therapeutic response.~   "
96454|NCT02304653|"~     Aim: To investigate if the results of CRP and leucocytes had any positive or negative~     influence on the surgeon's decision-making when handling patients with suspected AA.~   "
96455|NCT02304640|"~     There is a paucity of studies that focus on the symptom burden of cancer patients in~     Singapore, particularly the clinical effects of cancer-related fatigue (CRF). Knowing that~     early-stage breast cancer is curable, it is of paramount importance to evaluate the clinical~     and biological determinants of lingering symptoms in breast cancer survivors so that~     appropriate psychosocial interventions can be formulated.~   "
96456|NCT02304627|"~     This trial is conducted in Europe. The aim of the trial is to investigate the effect of food~     on the pharmacokinetics (the exposure of the trial drug in the body) of NNC0123-0000-0338 in~     a tablet formulation in healthy subjects.~   "
96457|NCT02304614|"~     3D surface imaging has been used in the objective evaluation of cosmetic outcome of~     oncoplastic procedures such as breast reconstruction and lipofilling, however there is only~     one article published relating to Breast Conserving Therapy (BCT).~      The aim of this study is to assess the use 3D surface imaging as a tool in the assessment of~     symmetry of outcome following breast conserving therapy. The results of the surface imaging~     will be correlated with patient satisfaction, using the BREAST-Q, which is a validated~     patient questionnaire and correlated with panel assessment by an independent panel of two~     surgeons, one clinical oncologist and one breast care nurse.~   "
96458|NCT02304601|"~     The primary objective of this research is the development and testing of a brief~     cross-indication instrument (screening) for use in the approval process of medical~     rehabilitation services. In addition to the empirical foundation, this generic instrument~     should have a high level of acceptance of both applicants and payers of rehabilitation~     services. Furthermore, an everyday and economic use for the routine application process for~     medical rehabilitation services at the German statutory pension insurance scheme should be~     provided. In the first study phase, a long instrument was tested with a sample of~     rehabilitees that received approval of medical rehabilitation services. This assessment~     including the measurement of rehabilitation-related somatic, psychological and social~     impairments was first tested for its psychometric properties and then reduced to a short~     instrument (screening) using quantitative methods. In the second study phase, the~     then-existing screening will be part of the application documents for medical rehabilitation~     services to assess its management properties and practicability in everyday use of the German~     statutory pension insurance scheme.~   "
96459|NCT02304588|"~     Mesenchymal stem cells with multidirectional differentiation potential,autologous stem cell~     transplantation into ischemic foot, make its differentiation to form new blood capillary,~     improve and restore the local blood flow.~   "
96460|NCT02304575|"~     Testicular Cancer is the most prevalent malignancy among men between 20 and 34 years of age,~     with incidence rates rising in western countries including Israel. Cure rate of testicular~     cancer exceeds 90% with modern treatments. Thus issues such as quality of life (QoL), coping,~     effects on couple relationships, cognitive function, cognitive orientation and hormonal~     function become increasingly important. This study aims to assess all these issues using~     validated, reproducible questionnaires and hormonal plasma levels, and compare them between~     testicular cancer survivors and controls.~   "
96461|NCT02304562|"~     Patients with skin injury treated with Umbilical Cord Blood-derived Mesenchymal Stem~     Cells,such as deep burn damaged sweat glands,Effectiveness of Umbilical Cord Blood-derived~     Mesenchymal Stem Cells in Regeneration of Sweat Glands and Body Repair is determined.~   "
96462|NCT02304549|"~     Benign prostatic hyperplasia (BPH) is a prevalent entity, affecting over 50% of men older~     than 60 years.In cases with moderate to severe lower urinary tract symptoms (LUTS) monopolar~     transurethral resection of the prostate (TUR-P) is the standard treatment. Especially in~     frail patients, conventional TUR-P is associated with relevant and potentially deleterious~     complications, e.g. TUR syndrome. Using isotonic saline, like in bipolar TUR-P and~     transurethral laser vaporization (TUV-P), TUR syndrome can be prevented.~      The short-term complication rate with the Thulium laser is similar to the rate described~     after vaporisation with other laser systems18-23 and less than that with TUR-P.~      Despite recent publications on the safety and complications with Thulium vaporisation of the~     prostate, to the investigators knowledge, until now, no prospective trial has directly~     assessed, whether absorption of irrigation fluid occurs and to what extent in Thulium Laser~     vaporisation of the prostate.~      The investigators therefore aim to investigate if absorption of irrigation fluid occurs~     during Thulium Laser vaporisation of the prostate by expired breath ethanol test.~   "
96463|NCT02304536|"~     210 women with clomiphene resistant PCOS will be randomly divided into 3 equal groups using~     computer generated random numbers. Group 1 will receive combined metformin and FSH, group 2~     will have LOD and group 3 will act as the control group with no intervention.~   "
96464|NCT02304523|"~     The purpose of this study is to evaluate the safety and efficacy of CDFR0612 and CDFR0613~     compared to PEG+picosulfate (Coolprep Powder) preparation. The effectiveness for bowel~     cleansing will be assessed with Harefield Cleansing Scale (HCS) by blinded assessor.~   "
96465|NCT02304510|"~     The purpose of the study is to estimate the prevalence of heavy menstrual bleeding (HMB) in~     females aged between 18 and 50 years old living in Bejing.~   "
96466|NCT02304497|"~     Diabetic patients may show different release of growth factors when microvascular~     complications such as; retinopathy or periodontitis are seen. Diabetes have an adverse effect~     on periodontal health and periodontal infection have an adverse effect on glycemic control~     and incidence of diabetes complications. Therefore, the investigators hypothesize that growth~     factors levels releasing from platelet rich fibrin (PRF) in diabetes mellitus (DM) may be~     decrease because of periodontitis is considered to be the sixth microvascular complication of~     diabetes or diabetes may have inductive effect on PRF growth factors levels in periodontal~     disease. Determination of PRF growth factors levels may be beneficial to treatment of~     diabetic patient with periodontal disease by using PRF.~   "
96467|NCT02304484|"~     To characterize the safety and tolerability of long-term administration of evolocumab in~     subjects with known coronary artery disease and hypercholesterolemia~   "
96490|NCT02304185|"~     The purpose of this study is to assess the safety and tolerability of 2 different dose levels~     of trimeric glycoprotein140 (gp140) administered as a 2-dosage regimen, intramuscularly~     (injection of a substance into a muscle), with and without aluminum phosphate as adjuvant in~     healthy human immunodeficiency virus (HIV)-uninfected participants.~   "
96491|NCT02304172|"~     The aim of this study is to compare the results of total thyroidectomy using the Thunderbeat~     device to that with the harmonic scalpel.~   "
96468|NCT02304471|"~     Cardiovascular disease is the major cause of morbidity and death in patients with chronic~     kidney disease (CKD) and end-stage renal disease (ESRD). The mechanisms linking impaired~     renal function and increased risk for cardiovascular diseases, however, remain elusive.~      Long non-coding RNAs (lncRNAs) is a heterogeneous group of non-coding transcripts longer than~     200 nucleotides. While the roles of lncRNAs in human diseases including cancer and~     neurodegenerative disorders are beginning to emerge, it remains unclear how lncRNA regulation~     contributes to cardiovascular complications in patients with renal dysfunction.~      In this proposal, the investigators seek to apply next-generation sequencing technology to~     investigate circulating lncRNA expression in control subjects and in patients with CKD and~     ESRD. The investigators will test the hypothesis that circulating lncRNA expression signature~     can reflect the underlying kidney disease states in patients with CKD and ESRD. A gene~     co-expression network analysis will be conducted to identify lncRNAs that are functionally~     involved in the pathogenesis of CKD and ESRD. Next, the investigators will identify~     circulating lncRNAs that are indicative of cardiovascular dysfunction in ESRD patients.~     Finally, the investigators propose to test the hypothesis that circulating lncRNAs can be~     novel prognostic biomarkers to predict cardiovascular outcomes and renal function progression~     in CKD patients. The results from these experiments will lead to better understanding of how~     circulating lncRNAs contribute to uremic cardiovascular complications and renal function~     progression.~   "
96469|NCT02304458|"~     This phase I/II trial studies the side effects and best dose of nivolumab when given with or~     without ipilimumab to see how well they work in treating younger patients with solid tumors~     or sarcomas that have come back (recurrent) or do not respond to treatment (refractory).~     Monoclonal antibodies, such as nivolumab and ipilimumab, may block tumor growth in different~     ways by targeting certain cells. It is not yet known whether nivolumab works better alone or~     with ipilimumab in treating patients with recurrent or refractory solid tumors or sarcomas.~   "
96470|NCT02304445|"~     This is a randomized, open-label, active comparator-controlled trial of subjects with~     advanced (Barcelona stage B/C) hepatocellular carcinoma. Subjects will be receive one~     treatment with Trans-Arterial Chemo-Embolization (TACE) prior to randomization. Subsequently,~     subjects will be randomized to observation or, if indicated, up to an additional TACE~     treatments, or to Stereotactic Body Radiotherapy (SBRT). Tumor response following~     interventions will be evaluated at three months.~   "
96471|NCT02304432|"~     The purpose of this study is to assess the efficacy of d-cycloserine (DCS) as an augmentation~     strategy in two psychotic patients with a triplication (4 copies) of the glycine~     decarboxylase (GLDC) gene. Subjects will first undergo an eight-week open-label arm of~     treatment with DCS (50 mg/d) followed by six 6-week double-blind placebo-controlled exposures~     to DCS or placebo. The length of each double-blind arm is limited to six weeks to minimize~     the length of symptom exacerbation experienced by the subjects when they are receiving~     placebo. The randomization scheme will allow two consecutive exposures to DCS, but will not~     allow two consecutive exposures to placebo, again to minimize the length of any symptom~     exacerbation. At the end of the open-label DCS trial, the following procedures will be~     carried out: structural MRI (3T), proton 1H MRS (4T), fMRI (3T), steady-state auditory evoked~     potentials, and electroretinogram recordings. In addition, 1H MRS (4T) for 2 hours after a~     single oral dose of a DCS will be assessed. Baseline data on all of these measures were~     previously obtained as part of a different study registered in clinical trials.gov -~     NCT01720316). Positive, negative, and affective symptoms and neurocognitive function as well~     as plasma levels of large neutral and large and small neutral and excitatory amino acids and~     psychotropic drug levels will be assessed periodically. Pharmaceutical grade DCS) or placebo~     will be compounded and dispensed by the McLean Hospital Pharmacy.~      The investigators hypothesize that mutation carriers will have reduced endogenous brain~     glycine and GABA levels and increased brain glutamate and glutamine levels. DCS~     administration will increase brain glycine in the two carriers compared to baseline and~     treatment with glycine (0.8g/kg).~      The investigators hypothesize reduced activation of magnocellular pathways and abnormal ERPs~     modulated by NMDA in mutation carriers compared with non-carrier family members and controls.~      . The investigators hypothesize that DCS, but not placebo, will improve positive, negative~     and affective symptoms as well as neurocognitive function.~      The investigators also hypothesize that DCS will improve clinical and cognitive functioning,~     will partially normalize decreased baseline glycine and GABA and increased glutamate and~     glutamine, and will partially normalize magnocellular pathway activation and abnormal evoked~     potentials.~   "
96472|NCT02304419|"~     The main purpose of this study is to learn more about how the study drug called galunisertib~     affects the immune system in participants with cancer. The study treatment is expected to~     last about six months for each participant, not including screening or follow-up.~   "
96473|NCT02304406|"~     Thet study aims to estimate the prevalence of ALK rearrangement in the Middle East North~     Africa population by using the Ventana ALK-IHC method for ALK protein detection in~     retrospective NSCLC clinical samples, & to evaluate the association of ALK rearrangement with~     clinical and pathological parameters of NSCLC patients in MENA.~   "
96474|NCT02304393|"~     This is an open-label, multicenter study designed to assess the safety, pharmacokinetics,~     pharmacodynamics and activity of RO7009789 administered in combination with atezolizumab~     (ATZ) in participants with metastatic or locally advanced solid tumors. The study will be~     conducted in two Parts (I and II), with Part I divided into Parts IA and IB. All participants~     will be followed up for survival until death or loss of follow-up after the last visit or~     withdrawal of consent.~   "
96475|NCT02304380|"~     The proposed study uses a recent policy change in Ohio as a natural experiment to assess~     outcomes and experiences of children who qualify for Medicaid under the Aged, Blind, Disabled~     category and their caregivers in an ACO model of care compared to their previous outcomes and~     experiences in a traditional fee-for-service model.~   "
96476|NCT02304367|"~     UX023T-CL201 is an, open-label, Phase 2 study. The study will be conducted in adults aged 18~     years or older with TIO or ENS whose tumor/skin lesion is inoperable to assess the efficacy~     and safety of KRN23 administered via subcutaneous injections monthly (every 4 weeks) for a~     total of 144 weeks. Subjects will need to discontinue oral phosphate and vitamin D metabolite~     therapy prior to randomization and throughout the duration of the study.~   "
96477|NCT02304354|"~     Rituximab, an anti CD-20 monoclonal antibody targeting B lymphocytes is prescribed in~     rheumatoid arthritis (RA) patients refractory to TNF alpha antagonists. According to previous~     studies, 25 to 50% of patients have an insufficient or absence of response to rituximab at~     week 24.~      In a recent retrospective study, a CD4+ T-lymphocytes depletion was observed after a first~     course of rituximab in RA patients. The absolute CD4+ number at week 12 was 37% (±33) of the~     baseline value, leading to < 200 cells/µL in 5% of patients. Interestingly the absence of~     CD4+ T-lymphocytes depletion was observed in clinical non-responders, suggesting the~     involvement of T-lymphocytes in the mechanism of action of rituximab. So far no prospective~     study have supported the usefulness of lymphocyte phenotyping, in particular T-lymphocytes,~     to monitor rituximab-treated RA patients.~   "
96478|NCT02304341|"~     Children are admitted in intermediate units when the severity requires continuous monitoring.~     In France, Resources allocated to intermediate units are determined from lists of diagnoses~     and associated acts to additional budget. A score to assess the severity of illness may be~     associated with acts to develop an activity indicator easy to use. The investigators have~     chosen 2 scores to assess severity in intermediate cares : the Paediatric Advanced Warning~     Score (PAWS) and the Bedside Pediatric Early System Score (PEWS). In France, they have not~     been validated. The correlation between the severity of children and the associated diagnoses~     and acts has not been studied. The main objective of this study is to validate these 2~     scores. The secondary objective is to determine a simplified activity indicator.~   "
96479|NCT02304328|"~     All patients (≥18 years) with a spontaneous SAH proven by computed tomography (CT), magnetic~     resonance imaging (MRI) or lumbar puncture will be considered for this trial. Upon~     presentation to a neurosurgical centre the patients will be treated according to the local~     protocol. Upon admission the patient is clinically evaluated for occurrence of clinical signs~     of brain herniation syndromes (anisocoria, bilateral dilated pupils, posturing). Usually~     first line treatment includes neurological resuscitation (placement external cerebrospinal~     fluid drainage in case of hydrocephalus, treatment of seizure, and general intensive care~     measures). Hereafter, the patient is clinically evaluated for a second time. The patients~     will be graded according to the usual WFNS scale and the modified herniation WFNS scale.~     The whole treatment of the patient will be according to local clinical protocols. Outcome~     will be measured at six and twelve months by trained investigators who are unaware of~     clinical data. The primary endpoint is the difference of specificities of the WFNS and hWFNS~     with respect to poor outcome (mRS 4-6) at 6 months after initial haemorrhage. Given that~     specificity and sensitivity are negatively correlated, difference in sensitivity will be the~     second primary outcome.~      The null hypothesis to be tested is that the ratio of the true negative rates (specificity)~     of the hWFNS and WFNS scores is 1.35 i.e. the new score will detect 35% more patients as~     truly negative (good outcome) as compared to the old score. In addition and because of the~     negative correlation between specificity and sensitivity we will also test that the ratio of~     the true positive rate (sensitivity) is not below 0.82 i.e. the new score will not more than~     18% less patients as truly positive (poor outcome).~   "
96480|NCT02304315|"~     This is a proof-of-concept study for GC1102 to demonstrate preventing the recurrence of~     hepatitis B virus (HBV) infection following liver transplantation and a dose-finding study to~     determine its optional dose.~   "
96481|NCT02304302|"~     The purpose of this research study is to learn if the medication Memantine Hydrochloride (the~     study medication) can help adolescents and young adults with Down syndrome. Dr. Alberto Costa~     and his research team want to see if a 16-week treatment with this medication can improve the~     participant's ability to learn and remember things. In this study, memantine hydrochloride~     will be used. Thus, the researchers want to learn whether the study drug can help improve~     memory in young adults with Down syndrome. To test the effect of the study medicine, half of~     the people in the study will receive the study medicine and half will receive a placebo (an~     inactive substance). Memantine is an approved medication to treat memory and thinking~     problems in persons with Alzheimer disease. However, little is known about the effect of this~     medication in persons with Down syndrome and it has not been approved for use in persons with~     Down syndrome.~   "
96482|NCT02304289|"~     The purpose of this study is to evaluate the Safety and Pharmacokinetics of Oral Artesunate~     in patients with advanced hepatocellular carcinoma (HCC)~   "
96483|NCT02304276|"~     This study will evaluate the two main types of replacement tissue heart valve used in current~     practice, comparing outcomes from surgical aortic valve replacement (AVR) with that of the~     more recently introduced key-hole procedure called transcatheter aortic valve implantation~     (TAVI). Participants will be recruited at various time points ranging from 1 month to 10~     years following valve replacement with either AVR or TAVI. It is thought that progressive~     calcium (chalk) formation is responsible for the failure of the majority of these valves. All~     participants will therefore have a PET-CT scan with a special type of tracer called~     18F-fluoride in order to measure active calcium formation in the valve. They will then have~     annual clinical follow-up for 5 years and be invited back for a repeat CT scan at 2 years to~     measure change in calcium burden. This study aims to investigate, firstly, the effects of~     valve age and type on calcium formation as measured by PET-CT and, secondly, whether this~     measure of calcium formation can help to predict how long different types of valve will last.~     If successful, 18F-fluoride PET-CT could become a valuable tool for testing new treatments to~     improve valve longevity and new valve designs.~   "
96484|NCT02304263|"~     Tenofovir continues to play a vital role in the treatment of the human immunodeficiency virus~     (HIV) and as the age of the HIV-infected population increases in the United States and~     worldwide, there is an urgent need to understand the extent to which older age influences the~     way this antiretroviral medication works in the body. The investigators study aims to~     characterize and compare the pharmacology of tenofovir in older versus younger HIV-infected~     adults and to assess kidney function over the course of approximately one year. The~     investigators will be analyzing tenofovir levels in different compartments of the blood and~     in hair samples, and will be assessing the relationship between tenofovir concentrations and~     changes in kidney function over time in the older and younger cohorts. Lastly, the~     investigators will be evaluating the relationship between tenofovir concentrations and~     functional status (including body composition, bone mineral density, and frailty) in study~     participants.~   "
96485|NCT02304250|"~     Dexamethasone is a potent glucocorticoid with analgesic and anti-emetic effects [1-3].~     Perioperative single-dose dexamethasone therapy has been used for several purposes: to reduce~     post-operative nausea and vomiting (PONV), pain and sore throat. There are also some reports~     on beneficial effects of less cardiac arrhythmia, improved appetite and less edema from~     glucocorticoids. Preoperative small dose of dexamethasone was reported to prevent reversal~     laryngeal nerve injury and improve voice quality after thyroid surgery. While accepted wildly~     in clinical anesthesia practice, the immune-press related potential risks of side effects~     associated with dexamethasone, such as delayed wound healing, infection, as well as effects~     on blood sugar, make the use of perioperative single dose of glucocorticoid controversial.~     The effect of perioperative dexamethasone on wound healing varied with different types of~     surgery. The present study will observe the effect of dexamethasone on the safety of thyroid~     surgery.~   "
96492|NCT02304159|"~     This is a randomized, open label, single center safety and efficacy study. At least 40~     cirrhotic subjects with HCV genotype 3 will receive standard of care treatment of sofosbuvir~     and ribavirin (SOF/RBV) as well as 60 mg daily of Daclatasvir (investigational product).~     Subjects will be randomized in a 1:1 to receive either:~        -  Group A: 16 weeks of DCV/SOF/RBV~        -  Group B: 24 weeks of DCV/SOF/RBV~      Subjects will return to the study center at various time points throughout the 16 or 24 weeks~     of treatment in addition to 12 weeks post taking last dose of study drug to monitor safety~     and efficacy. These visits will be according to standard of care.~   "
96493|NCT02304146|"~     The aim of this study is to investigate the long-term follow-up of the previously conducted~     FOAM study.~   "
96494|NCT02304133|"~     This study explores the effect of a four-hour ultrasound course on physicians' point-of-care~     ultrasound performance on patients representing acute abdominal surgical conditions.~   "
96495|NCT02304120|"~     This study evaluates the effects of additional sensorimotor training (proprioceptive postural~     training, PPT) to conventional therapy in the treatment of chronic low-back pain. Half of the~     participants will receive instructed treadmill training as an active comparator against PPT.~     All participants receive conventional physiotherapy as prescribed by their treating medical~     doctors. It is expected that the PPT group will improve in postural control, proprioceptive,~     as well as pain and function outcomes to a significantly greater extent than the active~     control group.~   "
96496|NCT02304107|"~     210 women with clomiphene resistant PCOS will be randomly divided into 3 equal groups using~     computer generated random numbers. Group 1 will receive FSH, group 2 will have Letrozole and~     group 3 will act as the control group with no intervention.~   "
96497|NCT02304094|"~     The aim of this study is to establish which of two treatment options is the preferred~     intervention in the treatment of Morton's Neuroma.~      A randomised controlled trial shall be performed. Steroid injection is the current gold~     standard conservative treatment for this condition. Therefore, manipulation shall be compared~     to a control group receiving a steroid injection in an equality randomised controlled trial.~      Outcomes will be compared using visual analogue pain scales (VAS), The Manchester-Oxford Foot~     Questionnaire (MOXFQ), The Foot and Ankle Ability Measure (FAAM), the SF-36 quality of life~     questionnaire and algometric pressure threshold testing. An improvement in either groups' VAS~     of 20mm above the other group shall be considered as the minimum worthwhile change as this~     has been identified as the minimum clinically important difference in pain between treatment~     groups in visual analogue pain scales.~      There is limited research evidence to support the management of Morton's neuroma with steroid~     injection although its efficacy has only been demonstrated in the short term.~   "
96498|NCT02304081|"~     The purpose of this study is to evaluate alpha- and beta-cell function during combination~     treatment with saxagliptin in addition to dapagliflozin and metformin compared to placebo in~     addition to dapagliflozin and metformin in subjects with T2DM on stable metformin background~     therapy.~   "
96499|NCT02304068|"~     Currently the best treatment for wet macular degeneration involves regular injections of~     Ranibizumab (Lucentis). In the initial clinical trials, the drug was injected into the eye~     every month. Since then a number of studies have found similar benefits when the drug is~     given with a fixed number of injections initially and then with further injections only when~     needed. This approach has been adopted in the UK, following recommendation by the National~     Institute for Clinical Excellence (NICE).~      Although this approach reduces the expense and risk of un-necessary treatment, it does~     require regular hospital assessment of disease activity to determine if a repeat injection is~     required or can be deferred. The hospital assessment is time-consuming, inconvenient and the~     large number of assessments can cause delays in hospital follow-up.~      Using three different assessment criteria to monitor disease activity at home, the~     investigators plan to see if home monitoring is as good as hospital assessment. The~     investigators have already identified that many patients dislike the lengthy hospital~     assessment visit and would welcome the opportunity to do some of the monitoring of disease~     activity at home. The investigators have also shown that they understand and can complete~     each of the home assessment tests. In this pilot project, the investigators aim to get an~     idea of how reliable home monitoring can be in a small sample of just over 30 patients. The~     data that the pilot project generates will be used to influence and to help plan a~     subsequent, larger, national study to be submitted for funding to the National Institute for~     Health Research.~   "
96500|NCT02304055|"~     200 women will be randomly divided into 2 equal groups using computer generated random~     numbers. Group 1 will receive Carbetocin 100 µgm (Pabal® Ferring, UK) and group 2 will~     receive oxytocin 5IU (Syntocinon®, Novartis, Switzerland).~   "
96501|NCT02304042|"~     250 women will be randomly divided into 2 equal groups using computer generated random~     numbers. Group 1 will receive Carbetocin 100 µgm (Pabal® Ferring, UK) and group 2 will~     receive oxytocin 5IU (Syntocinon®, Novartis, Switzerland). Both drugs will be diluted in 10ml~     saline and will be given by the slowly intravenously after delivery of the anterior shoulder.~     The investigators will not include a control group for ethical reasons.~   "
96502|NCT02304029|"~     Epilepsy is a common disease affecting 0.5 to 1% of the general population. Epilepsies~     refractory to drug treatment lead to increased morbidity, mortality and high costs for public~     health (representing 75% of the costs associated with epilepsy is among the most costly~     diseases in Neurology). The only curative therapy is surgical removal or disconnection of the~     epileptogenic network. To do this, a comprehensive presurgical evaluation is essential to~     accurately define the location of the epileptogenic zone (EZ) and its relationship with the~     functional areas that must be preserved. This approach requires in some cases intracerebral~     EEG recordings. This latter technique, expensive and invasive, remains at present, the~     standard method in the location of the ZE. In this context, the development of non-invasive~     and inexpensive methods is a priority in the field. Moreover, many fundamental studies have~     shown changes in ion homeostasis including sodium associated with hyperexcitability related~     to epilepsy. The investigators team at CEMEREM, CHU Timone, specialized in the development~     and validation of innovative methods in MRI, has developed an in vivo sodium MRI acquisition~     and processing of data unique in France, capable of quantifying the intracerebral sodium~     concentration in three dimensions in a completely non-invasive and non-irradiating manner~   "
96504|NCT02304003|"~     Primary aim of this study is to investigate wether an evidence-based physiotherapy regimen is~     more effective than standard care in patients referred for arthroscopic surgery of the~     shoulder. It is hypothesized that a multimodal physiotherapy regimen will relieve pain,~     improve shoulder function and reduce the need for subacromial decompression surgery of the~     shoulder compared to standard care/wait and see controls.~   "
96505|NCT02303990|"~     Phase I clinical trial of hypofractionated radiotherapy to an isolated index lesion in~     combination with the PD-1 inhibitor, Pembrolizumab in patients with metastatic cancers who~     have failed anti-PD-1 therapy (melanoma and NSCLC) and patients with metastatic cancers who~     have have progressed after at least one regimen of systemic therapy (breast, pancreas, and~     other).~   "
96506|NCT02303977|"~     The main purpose of this study is to see how well the combination of Abraxane and gemcitabine~     works in people with advanced adenocarcinoma NSCLC who have already had treatment for their~     disease. Gemcitabine and Abraxane are FDA approved chemotherapies; however, the FDA has not~     approved this combination in the treatment of this specific type of cancer. Patients may~     continue to receive the study drugs until their disease gets worse or they have unacceptable~     side effects.~   "
96507|NCT02303964|"~     Type A Thawed Plasma (TP) will be compared in polytrauma patients who receive only Normal~     Saline (NS) (standard of care) before arrival at the hospital.~      The purpose of this study is to determine if prehospital administration of thawed plasma can~     reduce mortality of patients who have lost a large amount of blood due to their injuries,~     compared to those receiving standard of care.~   "
96508|NCT02303951|"~     Evaluation of the efficacy, safety and biologic effects of neo-adjuvant treatment with~     vemurafenib + cobimetinib in patients with limited metastasis of melanoma in stage IIIC/IV~     melanoma.~   "
96509|NCT02303938|"~     The objective of this pilot randomized controlled trial (RCT) is to assess the feasibility~     and to determine the effect size of an exercise program in improving objective cognitive~     functioning.~   "
96510|NCT02303925|"~     With an estimated prevalence between 4 and 35%, the hemorrhoidal disease is the most frequent~     proctologic disease. Its symptoms are mainly rectorrhagia, externalization of the~     hemorrhoidal cushions (muco-hemorrhoidal prolapse), and/or pain and pruritus. Its acute~     complications (external and/or internal thromboses) are unpredictable.~      Surgical treatment concerns approximately 10% of patients with diagnosed hemorrhoidal~     pathologies. The elective ligature of the arteria haemorrhoidalis under trans-anal Doppler~     scanning was developed in order to reduce the postoperative morbidity of hemorrhoidal~     surgery. This technique consists in a ligation of the superior rectal artery under Doppler~     control in order to decrease the blood flow within the hemorrhoids and therefore to reduce~     them. It is effective in the treatment of internal hemorrhoidal pathology without prolapse~     (grade II). The complications rate is low and estimated between 2 and 12% : rectorrhagia~     (4.3%), thrombosed hemorrhoids (1,8%), fissure (0,8%), acute urine retention (0,7%).~      With the major advances in interventional radiology such ligation could be performed by an~     endovascular coil embolization. Until now no direct study exists on the subject but several~     case reports show the feasibility of an embolization of the superior rectal arteries for~     rectorrhagia of various etiologies such as the hemorrhoidal disease.~      Endovascular access should increase the selectivity of the embolization compared to the~     Doppler scanning technique. Indeed the arteriography makes it possible to scan all branches~     of the superior rectal artery and therefore to occlude permanently the branches that feed the~     hemorrhoidal plexuses. Moreover the endovascular embolization technique should avoid the main~     complications of the trans-anal access technique.~      The primary objective of this study is : the assessment of the efficacy of endovascular coil~     embolization of the superior rectal arteries in the management of the symptoms of the~     hemorrhoidal disease grade II and III. The secondary objective is : the assessment of~     postoperative complications.~   "
96511|NCT02303912|"~     A first in human experimental treatment in which an experimental medicine,Nuc-1031, is used~     in combination with a standard cancer medicine, carboplatin, to treat ovarian cancer which~     reappear after standard cancer treatment. The aim of the trial is to determine safety,~     effectiveness, and clinical activity of this combination treatment.~   "
96512|NCT02303899|"~     This is a phase II, monocentric study of the combination of gemcitabine and imatinib mesylate~     in pemetrexed-pretreated patients with MPM expressing PDGFR-beta and/or C-kit by~     Immunohistochemistry (IHC). Treatment will be done until disease progression, or patient~     refusal or withdrawal of patient consent, or unacceptable toxicity~   "
96513|NCT02303886|"~     Aim of Investigation Methylene blue (MB) is a diaminophenothiazine with antioxidant,~     anti-inflammatory properties and with inhibitory effects on nitric oxide. The aim of this~     study was to determine the clinical effectiveness of MB in the treatment of neuropathic pain.~      Methods Ten patients with neuropathic pain were randomized to receive one of the two~     treatments: methylene blue (MB1) 2 mg/kg (10 mg/mL Methyltioninklorid, Apoteket, Umeå,~     Sweden) or methylene blue (MB2) 0.02 mg/kg. Both MB solutions were infused intravenously over~     60 minutes. The sensory function and the pain were evaluated at baseline and at 60 min after~     the start of infusions. A pain journal was kept by the patients in the following 5 days.~     Plasma and urinary concentrations of 8-isoprostane-prostaglandin F2α (8-iso-PGF2α) an~     indicator of oxidative injury, were measured with radioimmunoassay (RIA). A panel of 92~     proteins biomarkers were determined with Proximity Extension Assay (PEA) prior and after~     infusions.~      comparison with the control group. MB infusion produced an enhancement of prolactin.~   "
96514|NCT02303873|"~     Alendronate should be considered as an alternative therapy of osteogenesis imperfecta (OI)~     because it significantly increased areal bone mineral density (BMD) and its Z score,~     decreased fracture incidence, inhibited bone resorption biomarkers. Alendronate exerted~     beneficial roles in different age brackets, especially in young patients with OI.~   "
96515|NCT02303860|"~     The purpose of this study is to evaluate ORM-12741 concentrations in blood at steady state.~   "
96516|NCT02303847|"~     This project is a pilot study to evaluate the analgesic and opioid-sparing effects of~     ketamine in an ultra-low dose oral formulation as a novel intervention for treatment of~     chronic non-cancer pain in opioid-tolerant patients in the primary care outpatient setting.~   "
96530|NCT02303665|"~     Objective: To evaluate the curative effect of TCM multi-channel interventional therapy on~     women with ART Failure; to compare the curative effect of the dual therapy and triple therapy~     on women with ART Failure; to choose the best TCM interventional therapeutic plan.~      Methods: The cases with ART Failure from West China second University Hospital of Sichuan~     University (West China Women's and Children's Hospital of Sichuan University) meeting the~     inclusion criteria were randomly divided into three groups: the dual therapy group, the~     triple therapy group and the control group, compare the natural pregnancy number, the~     condition during the period of secondary IVF-ET and the improvement of the kidney deficiency,~     liver depression and blood stasis syndrome among those three groups.~   "
96531|NCT02303652|"~     This study aimed at evaluating multiple aspects of biatrial contractility recovery after~     modified maze procedure during mitral valve surgery.~   "
96517|NCT02303834|"~     Study design:~      Single blinded randomised control trial~      Planned sample size:~      30 (women randomized 2:1 to receive either CPAP or no CPAP)~      Objectives:~      Primary objective: Assess the effects of nasal CPAP on sleep physiology, 24 blood pressures~     and fetal movements in pregnant women (24-37 weeks gestation) with preeclampsia.~      Secondary objective: Assess baseline sleep physiology, blood pressure control and fetal~     well-being in pregnant women (24-37 weeks gestation) with preeclampsia by completing sleep~     studies, 24 hour blood pressure monitors, CO2 monitors, and nocturnal fetal movement and HR~     monitors.~      Study Procedure:~      Participants will be recruited from the antenatal ward or high-risk antenatal clinic.~     Following informed consent participants will be randomly assigned to receive either CPAP or~     no CPAP for one night, following an initial baseline overnight sleep study.~      Baseline- Night 1~        1. Sleep study with fetal movement and HR monitor~        2. 24 hour BP monitor~        3. CO2 monitor~      Intervention- Night 2 (Nasal CPAP device or no CPAP)~        1. Sleep study with fetal movement and HR monitor~        2. 24 hour BP monitor~        3. CO2 monitor~      Post-partum questionnaire A brief questionnaire to be completed within the first 6 weeks~     post-partum related to the participant's personal health, their child's birth details and~     health.~   "
96518|NCT02303821|"~     The purpose of the study is to determine the maximum tolerated dose and assess the safety,~     tolerability and activity of carfilzomib, alone and in combination with induction~     chemotherapy, in children with relapsed or refractory acute lymphoblastic leukemia (ALL).~   "
96519|NCT02303808|"~     This trial aims to analyze whether the inhalation of hypertonic saline combined with a~     positive expiratory pressure (PEP) device increases the amount of sputum expectorated during~     the chest physiotherapy session ( inhalation + bronchial drainage).~   "
96520|NCT02303795|"~     RIvaroxaban for Valvular heart diseasE and atRial fibrillation trial (RIVER trial).~   "
96521|NCT02303782|"~     This study is designed in its first part (phase Ib) to determine the recommended dose of the~     OTX015 + Vidaza (azacitidine) combination in newly diagnosed acute myeloid leukemia patients~     not candidate for standard intensive induction therapy.~      It will be followed by a randomized phase II part to assess the efficacy of the combination~     using 2 arms : Vidaza (azacitidine) alone vs. OTX015 in combination with Vidaza~     (azacitidine).~   "
96522|NCT02303769|"~     Study to investigate the efficacy and safety of GL2702 GLARS-NF1tablet and Harnal-D - tablet~     in benign prostatic hyperplasia patients with lower urinary tract symptomatic~   "
96523|NCT02303756|"~     The primary aim is to evaluate the efficiency of capsule endoscopy (CCE) in in the detection~     of neoplasms compared to conventional colonoscopy in persons participating in the Danish~     screening program for colorectal cancer with a positive fecal occult blood with the~     colonoscopy being the gold standard.~   "
96524|NCT02303743|"~     Getting ready for a colonoscopy is difficult and involves a lot of steps. The information~     given to patients is very important to adherence to treatment. The investigators have created~     a novel smart phone application (SPA) aimed to increased bowel preparation quality and~     patient satisfaction, using different educational tools.~   "
96525|NCT02303730|"~     The purpose of this study is to evaluate whether exenatide is superior to insulin glargine~     (after 24 weeks) in reducing liver fat content (by MRS) in patients with newly diagnosed type~     2 diabetes mellitus and concomitant non-alcoholic fatty-liver disease(NAFLD).~   "
96526|NCT02303717|"~     A prospective, randomized, multicenter study in patients with an indication for coronary~     artery revascularisation who have been accepted for percutaneous coronary intervention (PCI)~     of the left main coronary artery. Patients will undergo standard PCI of the left main~     coronary artery and will be randomized in a 1:1 fashion to the Synergy stent or to the XIENCE~     stent. Dual antiplatelet therapy (DAPT) will be stopped at t=4 months in the Synergy arm~     whereas in the control arm DAPT will be continued for 12 months. A subgroup of 100 patients~     will have control angiography with Optical Coherence Tomography (OCT) at t=3 months after~     treatment.~   "
96527|NCT02303704|"~     In spite improvements in methods of myocardial protection, peri-operative myocardial damage~     is still the commonest cause of early morbidity and mortality after technically successful~     CABG Surgery. What is the optimum method of myocardial protection is still debatable.~      The investigators conducted this study to see effects of multiport antegrade cold blood~     cardioplegia on myocardial protection, along with continuous controlled warm blood perfusion~     through veins graft during proximal ends anastomosis in conventional CABG surgery in patients~     having multi-vessel disease.~   "
96528|NCT02303691|"~     This project seeks to identify neural mechanisms underlying the tendency for anxious~     individuals to pay more attention to threatening information than to other types of~     information. A computerized treatment designed to train individuals to reduce their attention~     towards threat will be tested, with a focus on understanding the aspects of brain function~     that predict response to the treatment. This work could ultimately lead to the ability to~     treat anxiety more effectively by directly targeting the aspects of brain function that are~     altered in a given patient.~   "
96529|NCT02303678|"~     This is a Phase I study to determine the maximum tolerated dose (MTD) of D2C7-IT (D2C7~     Immunotoxin) when delivered intratumorally by convection-enhanced delivery (CED) to recurrent~     World Health Organization (WHO) grade III (dose escalation only) and IV (dose escalation and~     dose expansion) malignant glioma patients, and to determine what dose will be considered in a~     single-arm Phase II trial. Patients with recurrent WHO grade III (dose escalation only) and~     IV (dose escalation and dose expansion) malignant glioma who meet eligibility criteria will~     be enrolled into the study. Immediately following stereotactically-guided tumor biopsy,~     subjects will have catheters inserted. If the frozen section of the biopsy indicates a proven~     diagnosis of recurrent malignant glioma (diagnosis results are typically received within~     24-48 hours following biopsy), the investigators will proceed with the D2C7-IT infusion. If~     not, the catheters will be removed. A continuous intratumoral infusion of D2C7-IT will be~     administered and the same total flow rate for all catheters will be set at 0.5 ml/hour per~     catheter for 72 hours.~   "
96532|NCT02303639|"~     The study evaluates whether catheter based radiofrequency ablation is superior to optimized~     antiarrhythmic medical therapy in preventing ventricular tachyarrhythmia relapses in patients~     with ischemic heart disease and implantable cardioverter defibrillator.~   "
96533|NCT02303626|"~     This study will evaluate the safety and efficacy of an oral treatment, BCX4161, in preventing~     acute attacks in subjects with hereditary angioedema (HAE). Eligible subjects will be~     randomized to receive one of two doses of BCX4161 or placebo for 12 weeks. The study will~     compare the number of acute attacks in each treatment group, as well as a number of other~     clinical outcomes, and the safety and tolerability of each dose of BCX4161 compared to~     placebo.~   "
96534|NCT02303613|"~     Background: Triage in the emergency department (ED) together with initial assessment is used~     to identify patient's level of urgency and treatment based on their triage level. Triage in~     the ED is a complex decision-making process, and several triage scales have been designed as~     decision support systems to guide the triage nurse to a correct decision. Worldwide there are~     four well known five-level triage systems in use. In 2010, 97% of all EDs in Sweden~     introduced a process-oriented triage scale with physiological parameters called Rapid~     Emergency Traige and Treatment System (RETTS). RETTS has two main assessment variables: vital~     signs and chief complaints, which describe the incident or symptoms that caused the patient~     to seek care. These two variables are evaluated and results in a color coded 5-level scale.~     Each level of priority has a defined time limit within which evaluation by a doctor should~     begin. Although, all international triage system guidelines seem to function well in western~     countries, they are difficult to implement and have a high failure rate in developing~     low-income countries. One of the reasons may be the lack of extensive training. Teaching and~     assessing abilities in performing mass casualty triage in inherently challenging due to the~     inability to accurately replicate a given disaster environment in a comprehensive way.~     Disaster drills and simulation exercises are ways of training triage performance and there~     are different tools available. One tool that can contribute to this kind of training may be~     the Emergo Train System® (ETS). ETS or similar interactive educational simulation systems~     could be used to test and evaluate incident and command systems, surge capacity, hospital~     preparedness and triage.~      Study objective study III: The aim of the study is to validate the currently practiced system~     for triage in the ED in Moi Teaching and Referral Hospital in Eldoret, Kenya with RETTS.~     Furthermore map the current patient outcome of trauma patients.~   "
96535|NCT02303600|"~     Cough is a common symptom of respiratory medicine clinic patients, which has complex etiology~     and wide-ranging. Cough is usually divided into three categories by time: acute cough,~     subacute cough and chronic cough. Subacute has a 3~8 weeks course of disease. Its main~     etiology is postinfectious cough, which is mostly secondary to viral infection.Considering~     its overexpression in postinfectious patient, Cysteinyl leukotriene (CysLTs) plays a role in~     gathering eosinophils to respiratory. The level of FENO has a significant correlation with~     inflammatory airway eosinophils. While CysLTs overexpressed in vivo, the level of FENO may~     increase. Montelukast, as CysLTs-receptor-1 antagonists， plays a role of controlling airway~     inflammation and decrease airway high activity by suppressing the biological activity of~     CysLTs. It is effective in theory to therapy sub-acute cough by Montelukast, to short the~     course and to relieve cough symptoms as soon as possible. The aim is to research whether FENO~     can be used as a biomarker to optimized treatment regimen of sub-acute cough.~   "
96536|NCT02303587|"~     The study is designed to investigate difference in percentage of presentation of atelectasis,~     bronchiectasis, bronchiolitis obliterans, or consolidation in 6 months after discharge in~     those treated with a low dose regimen of methylprednisolone initiated with 2 or 4 mg/kg/d for~     3 days followed by tapering, combined with sequential treatment with azithromycin versus a~     high dose regimen of methylprednisolone initiated with 10 mg/kg/d for 3 days followed by~     tapering, combined with sequential treatment with azithromycin.~   "
96537|NCT02303574|"~     This is a phase I, randomised, single-blind placebo-controlled, 2-part study to assess the~     safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of single and~     multiple oral doses of AZD7986 in healthy volunteers~   "
96538|NCT02303561|"~     Overweight and obese (OV/OB) children with asthma are at-risk for particularly poor health~     outcomes including poor asthma control, higher risk of asthma-related symptoms, and decreased~     quality of life. Weight loss reduces asthma symptoms, improves lung function, and increases~     quality of life among OV/OB adults with asthma. Little research has examined the impact of~     weight loss on asthma outcomes in OV/OB youth, and there is little research examining weight~     management interventions in OV/OB children with asthma. Behavioral family-based lifestyle~     interventions are successful in producing weight loss in children. To our knowledge, however,~     there has been no systematic effort to examine the impact of these interventions on weight~     status and asthma outcomes, nor has there been an effort to tailor these programs to the~     specific needs of OV/OB children with asthma.~      The aims of this study are to develop and test the Childhood Health and Asthma Management~     Program (CHAMP), a behavioral family-based lifestyle intervention that is community-based to~     promote successful weight and asthma management in OV/OB children with asthma. The~     investigators propose to develop an intervention based on a previously developed behavioral~     family-based lifestyle intervention that was community-based and produced positive long term~     weight status changes in OV/OB children and tailor it for OV/OB children with asthma to~     create CHAMP. CHAMP will include asthma education and targeting unique barriers to weight~     management in OV/OB children with asthma. A focus group will be conducted with OV/OB children~     with asthma, ages 6-12, and their parent(s). Then a pilot randomized controlled trial of the~     CHAMP intervention with 32 OV/OB children with asthma, ages 6-12 years, and their parent(s).~     Families will be randomly assigned to CHAMP or a health education group. The investigators~     hypothesize that participants in CHAMP will have more effective weight and asthma management~     and child asthma outcomes compared to those in the general education group.~   "
96539|NCT02303548|"~     A pilot study to evaluate the effect of sodium bicarbonate administration on cardiopulmonary~     resuscitation results and outcomes in cardiac arrest patient with severe metabolic acidosis.~   "
96540|NCT02303535|"~     The National Institute of Cardiovascular Outcomes Research (NICOR) collects data and produces~     analysis to enable hospitals and healthcare improvement bodies to monitor and improve the~     quality of care and outcomes of cardiovascular patients.~      The Congenital Heart Disease audit collects data on all cardiac surgery and therapeutic~     cardiac catheterisations procedures used to treat patients with congenital and acquired heart~     disease.~      For acquired heart disease, the audit covers all arrhythmias & cardiomyopathies in patients~     less than 16 years old only. For congenital heart disease, the audit collects data on both~     children and adult patients. The audit covers all specialist centers in the UK and Republic~     of Ireland.~      The project aims to improve the quality of care for children and adults with congenital heart~     disease by providing national comparative analysis of procedure specific activity and~     outcomes of cardiac surgery and therapeutic cardiac catheterisation procedures. The audit~     also provides quality indicators for the antenatal detection of major congenital heart~     disease.~      The current dataset is available from here:~      http://www.ucl.ac.uk/nicor/audits/congenital/datasets~   "
96541|NCT02303522|"~     An historical data comparator study for children with relapsed/refactory acute lymphoblastic~     leukemia (ALL).~   "
96542|NCT02303509|"~     To evaluate the safety and tolerability of UCB5857. Part 1 of the study explores single doses~     of the drug. Part 2 of the study explores giving the drug every day for 14 days. The study~     uses healthy and psoriasis subjects.~   "
96557|NCT02303314|"~     This study design to examine performance of trigonella foenum-graecum (TFG) in treatment of~     non-alcoholic fatty liver disease. Base on inclusion and exclusion criteria, 50 patients~     select and then randomize into intervention and control groups. Two group use capsules which~     contain TFG or placebo, respectively.~   "
96543|NCT02303496|"~     Human skin undergoes some morphological changes with the effects of chronological aging and~     photoaging, these are especially remarkable in the facial skin. Changes in pigmentation,~     sallowness, deep wrinkling, laxity and elastosis are the main changes seen in photoaging and~     chronologic aging of skin. With the increasing demand, it needs to provide new approach for~     the prevention and treatment of these morphological changes.~      Fibroblasts have a key role on skin aging. It is known that platelet rich plasma activates~     the fibroblasts and increases the synthesis of collagen and other type of matrix components.~     Because of these specialities, platelet rich plasma is thought to be effective on skin aging.~   "
96544|NCT02303483|"~     In animals, treatment with vitamin B3 improved insulin sensitivity and substrate metabolism.~     It is currently not know if vitamin B3 has the same positive effects in humans. In the~     current study the effect of a 3 month treatment with vitamin B3 on insulin sensitivity and~     substrate metabolism in obese men will be investigated.~   "
96545|NCT02303470|"~     This study evaluates the feasibility and metabolic effects of implementing a structured~     exercise program in women with polycystic ovary syndrome and insulin resistance. Participants~     will be randomized to either 75 minutes of vigorous exercise or 150 minutes of moderate~     exercise per week.~   "
96546|NCT02303457|"~     Open surgery and CO2 laser surgery are both established treatment modalities for T1N0 glottic~     carcinoma. It is controversial for T1N0 glottic carcinoma with anterior commissure involved.~   "
96547|NCT02303444|"~     The purpose of the study is to assess the use of Multikinase Inhibitors (MKIs) in the~     treatment of patients with a progressive differentiated thyroid carcinoma (DTC) refractory to~     radioactive iodine (RAI) who do not have any symptoms.~   "
96548|NCT02303431|"~     This is the first evaluation of edoxaban in pediatric subjects. In this Phase 1 study, a~     single dose of edoxaban will be given to pediatric subjects who require anticoagulant therapy~     to see what the body does to the drug (pharmacokinetics) and what the drug does to the body~     (pharmacodynamics), and to compare if these effects are similar to those observed in adults.~   "
96549|NCT02303418|"~     The study aims at comparing the roles of carbetocin and oxytocin in the prevention of atonic~     PPH in women undergoing CS for placenta previa.~      200 women will be randomly divided into 2 equal groups using computer generated random~     numbers, Group 1 will receive Carbetocin 100 µgm (Pabal® Ferring, UK) and group 2 will~     receive oxytocin 5IU (Syntocinon®, Novartis, Switzerland).~   "
96550|NCT02303405|"~     A 4-month, randomized, prospective, open-label comparison trial of hydroxychloroquine vs.~     pioglitazone in type 2 diabetic patients inadequately controlled on maximally tolerated doses~     of metformin plus a sulfonylurea.~   "
96551|NCT02303392|"~     This phase I trial studies the side effects and best dose of selinexor when given together~     with ibrutinib in treating patients with chronic lymphocytic leukemia or aggressive~     non-Hodgkin lymphoma that has returned after a period of improvement or does not respond to~     treatment. Drugs used in chemotherapy, such as selinexor, work in different ways to stop the~     growth of cancer cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Ibrutinib may stop the growth of cancer cells by blocking some~     of the enzymes needed for cell growth. Giving selinexor together with ibrutinib may be a~     better treatment for chronic lymphocytic leukemia or aggressive non-Hodgkin lymphoma.~   "
96552|NCT02303379|"~     It is the aim of our study to compare the effects of 6 and/or 2 years of either HIT (carried~     out at correctly assessed 85-95% of maximal heart rate), pyramid, or continuous endurance~     training, on changes of physical exercise capacity in cardiac patients.~   "
96553|NCT02303366|"~     This is a prospective, observational pilot study that will describe the safety profile and~     biological effects of combining stereotactic ablative body radiosurgery (SABR) treatment~     (20Gy/1#) and a PD-1 antibody, MK-3475.~      15 patients with oligometastatic breast cancer with at least one lesion considered safe for~     SABR radiotherapy, will be treated with SABR for their oligometatastic disease in addition to~     6 months of MK-3475 treatment (1 cycle every 3 weeks, a total of 8 cycles).~      This investigator driven pilot study will examine the safety and biological effects of~     combining MK-3475 (Pembrolizumab) an antibody targeted against the anti-programmed cell death~     1 (PD-1) T cell checkpoint, with SABR therapy for oligometastatic disease. We hypothesise~     that the safety profile of this combination, will be clinically acceptable and well tolerated~     for patients, and that we will observe evidence of systemic immune activation.~   "
96554|NCT02303353|"~     The purpose of this registry is to evaluate the situation regarding ambulant therapy of~     cancer patients in different practices in Germany. It should provide insight into the~     implementation of schemes for cancer therapy predefined in the guidelines, the treatment of~     diverse adverse reactions and the counter measures taken. Thereby, potential differences in~     treatment and with that differences in quality amongst individual practices might be~     identified. The medium to long term aim is to contribute to positively influence the quality~     of medical care of cancer patients in Germany.~   "
96555|NCT02303340|"~     The purpose of this study is to elucidate the role of Dental Cone Beam Computed Tomography~     (CBCT) in assessment of bone density. The study population contains men and women above the~     age of 60 years, eligible for Bone Density Testing in accordance with their health insurance,~     who underwent a Dental CBCT recommended by their Dental Practitioner. Any patient (eligible~     for bone density screening by age criteria) undergoing CBCT of either one of the jaws (or~     both) due to dental reasons, will be sent to a bone mineral density DEXA Scan, and for blood~     testing for PTH, Phosphor, Calcium ,Vitamin D and Creatinine levels.~      Density measurements will be done in specific sites on the CBCT's of the jaws. These~     measurements will be correlated with the blood tests and DEXA scan results.~   "
96556|NCT02303327|"~     In North America, the number of new cases of prostate cancer increases every year. Many~     efforts have been made to develop more efficient and safer curative treatments for high risk~     prostate cancer patients.~      This phase III clinical trial is designed to compare the safety of a standard pelvic external~     beam radiation therapy (EBRT) combined with a high dose rate brachytherapy (HDRB) boost~     (direct insertion of radiation source over a period of minutes via flexible needles~     temporarily inserted in the prostate) to a shorter course of hypofractionated dose escalation~     radiotherapy (larger radiation dose per daily treatment) in patients with high risk prostate~     cancer.~      The investigators plan to recruit 296 patients across Quebec who will be randomized in either~     treatment plan.~   "
96558|NCT02303301|"~     Hospitalised patients have in contrast to healthy people enteric pathogenic bacteria in their~     oropharynx Increased risk of pneumonia due to the pathogens in the oropharynx Probiotics can~     reduce such bacteria in intubated critically ill patients This study will use two strain of~     probiotic bacteria for half of the patients and a placebo for the rest Active arm gurgles~     with a suspension twice a day Cultures at inclusion and at set time intervals The results of~     cultures from the two groups will be compared as will the use of antibiotics~   "
96559|NCT02303288|"~     This is a post-market study of the Argus II Retinal Prosthesis System. The study is being~     conducted in France. The objective of the study is to obtain data to further demonstrate the~     effectiveness and evaluate the safety of Argus II System in patients with retinitis~     pigmentosa who have a bare light perception or worse in both eyes.~   "
96560|NCT02303275|"~     Summary~      Chronic heart failure continues to be one of the highest economic burdens in the United~     States, heavily influenced by frequent readmissions to the hospital. This study will examine~     whether patients 65 years and older, who have NYHA class II and III heart failure, will~     improve their symptoms after participating in a comprehensive 12-week lifestyle change~     program. The investigators will recruit potential subjects primarily from the Scripps Clinic~     heart failure clinic at the Torrey Pines campus. Qualifying subjects will be randomized to~     medical treatment as usual or the lifestyle program. The investigators will enroll 17~     subjects into each group which will provide 80% power and an alpha of 0.05.~      The lifestyle change program consists of classes conducted three times a week for 12 weeks at~     the Scripps Center for Integrative Medicine. Each day participants will spend about four to~     five hours in a variety of classes such as monitored exercise, group support, mindful-yoga~     and meditation, vegetarian cooking classes, music-centered wellness, mind-body lectures, and~     resiliency training.~      The primary outcomes will focus on determining functional status and physical agility using~     the 6-minute walk test, handgrip strength, and NYHA class categories. In addition, the~     investigators will capture subjective physical status with a self-reported questionnaire.~     Cognitive assessment will be performed using the Montreal Cognitive Assessment tool. To~     capture the subject's overall self-reported improvement the investigators will use a quality~     of life and a depression questionnaire. Secondary endpoints include hospital admission rates~     and all-cause mortality.~   "
96561|NCT02303262|"~     The purpose of this study is to assess the response rate (per RECIST 1.1) in participants who~     receive mocetinostat and gemcitabine after documented progression of leiomyosarcoma on a~     gemcitabine containing regimen.~   "
96562|NCT02303249|"~     The study aims to assess whether the review of discharge planning followed by a~     cross-sectoral video conference in connection with discharge of medical and geriatric~     patients at Roskilde and Køge hospitals as well as patients from the Emergency Department at~     Køge Hospital reduces the proportion of patients who are readmitted within 180 days.~      Project nurses at the two hospitals identifies all patients fulfilling the inclusion criteria~     (above 55 years of age, discharged to their own home), get informed consent and performs the~     video conferences. Within a few hours after discharge a video conference is held in the~     patient´s home including the patient,the municipal nurse and the project nurse at the~     hospital. During the video conference the discharge is reviewed using a structured~     assessment.~      The survey is conducted as an open, randomized intervention study.~   "
96563|NCT02303236|"~     Establishing the association between biological markers and exercise capacity in~     continuous-flow left ventricular assist device patients.~   "
96564|NCT02303223|"~     The principle objective of this study is to evaluate pharmacokinetics of propofol after~     single iv bolus dose in 12 Indian children and to develop a simple pharmacokinetic model of~     propofol.~   "
96565|NCT02303210|"~     The purpose of this study is to examine two frequency lowering techniques in case of~     audibility, recognition, distinction, discriminability and sound quality.~   "
96566|NCT02303197|"~     This study evaluates the efficiency and safety of ChiNing decoction to head and neck cancer~     patients with radioactive stomatitis. Half of participants will receive ChiNing decoction,~     while others will receive recombinant human epidermal growth factor (rhEGF) spray.~   "
96567|NCT02303184|"~     A phase 2, multicenter, randomized, active-controlled, masked, parallel arm study designed to~     evaluate the safety and efficacy of a single suprachoroidal injection of CLS-TA,~     triamcinolone acetonide injectable suspension, given along with an intravitreal (IVT)~     injection of aflibercept compared to IVT aflibercept alone in subjects with retinal vein~     occlusion (RVO).~   "
96568|NCT02303171|"~     Evaluation of shifting to oral vitamin K antagonist after the first trimester instead of~     using low molecular weight heparin (LMWH) throughout pregnancy in pregnant women with~     antiphospholipid syndrome (APS)~   "
96569|NCT02303158|"~     It is currently accepted that depression during midlife is a risk factor for Alzheimer's~     disease (AD). Furthermore, several prospective population studies have demonstrated that~     depression is an independent risk factor for incident dementia of different types (e.g.~     vascular, mixed, Alzheimer's disease). However, it is not clear, what are the mechanisms that~     link depression and dementia, and if depression can be a prodromal manifestation of AD. There~     are also studies that suggest that depression could be an initial sign of AD.~      Objective:~        1. Demonstrate that late life depression (over 60 years of age) constitutes the first~          manifestation of AD.~        2. Define by rating scales and life stressors have differential risk profiles evolutionary~          AD.~        3. To study the relationship between the subtypes of depression and CSF biomarkers,~          neurophycological test and evolution to AD.~   "
96581|NCT02303002|"~     This is a safety and efficacy study of botulinum toxin type A in subjects with glabellar~     frown lines.~   "
96582|NCT02302989|"~     To evaluate Ranibizumab as prophylaxis against the conversion to neovascular Age-Related~     Macular Degeneration~   "
96583|NCT02302976|"~     The investigators plan to explore the effects of acute pre-treatment with the glucagon like~     peptide-1 (GLP-1) agonist, exenatide versus placebo, on the subjective (e.g., euphoric) and~     behavioral effects (e.g., self-administration) of cocaine in experienced, non-treatment~     seeking users of the drug. Additionally, the investigators plan to explore the effects of~     sub-chronic (5-day) treatment with exenatide as compared to placebo on the subjective (e.g.,~     euphoric) and behavioral (self-administration) effects of cocaine in experienced,~     non-treatment seeking users of the drug.~   "
96570|NCT02303145|"~     The proposed study seeks to evaluate the relationship between biopsychosocial functioning and~     work-related cognitive limitation among employed breast cancer survivors in a cross-sectional~     study with healthy control group. Specifically, this study will assess work-related cognitive~     limitation in association with depression, anxiety, pain, fatigue, sleep disturbance, and~     cognitive deficit of employed women with and without history of breast cancer. The primary~     purpose of this study is to assess the impact of objective cognitive functioning as a better~     predictor of cognitive shortcomings at work place in comparison to a self-report cognitive~     measure. The secondary purpose is to assess work related cognitive limitation in breast~     cancer survivors in comparison to their counterparts (employed women without history of~     cancer diagnosis). The third purpose is to explore how sociodemographic variables such as~     marital status, education, age, race, and ethnicity relates to perceived cognitive limitation~     at work among breast cancer survivors. Additionally, the study will examine the effects of~     medical variables as covariates on these relationships. Subsequently, the study will examine~     the level of mindful attention and awareness as a possible mediator between the~     psychological, somatic and cognitive distress and the work-related cognitive limitation.~      In this observational study, the control group is added as a mean to compare differences~     between groups and that no variables is being manipulated in this study. This precludes this~     research from being a quasi- or a true experimental design.~   "
96571|NCT02303132|"~     Medication use, especially NSAIDs and PPIs, prior to diagnosis is considered a risk factor~     for MC development. However, the exact pathophysiological mechanism is unclear. It is~     hypothesized that NSAIDs, PPIs, and SSRIs may have an effect on the colon permeability, due~     to an idiosyncratic reaction which results in a local immune response. MC patients are~     considered to be susceptible hosts, prone to react on administration of abovementioned drugs.~     In order to test this hypothesis and to generate new insights in the pathophysiology of MC,~     we want to perform an Ussing chamber experiment using fresh colon tissue samples. The primary~     objective is to assess ex vivo the effect of NSAIDs and PPIs on epithelial permeability of~     colon biopsy specimens of MC and non-MC patients, using the Ussing chamber system~   "
96572|NCT02303119|"~     Patient will receive either one infusion of rituximab IV and seven administrations of~     rituximab SC (experimental arm) or four infusions of rituximab IV (standard arm).~      The hypothesis is that the use of rituximab by sub cutaneous route and the scheme of~     administration could:~        -  optimize rituximab exposure leading to improve response rate~        -  increase adaptative response and then improve long-term control disease.~   "
96573|NCT02303106|"~     The investigators will study the effect of paracetamol on the steady state metabolism of~     lamotrigine in 12 healthy male volunteers.~      Subjects will receive lamotrigine, slowly titrated from 25 mg daily to 100 mg daily over 28~     days. On day 36, full plasma and urine PK samples will be drawn. On days 37-40 the subject~     will be co-administered 1 gr paracetamol 4 times daily. On day 40 the sampling will be~     repeated.~      Primary outcome parameter is Lamotrigine AUC before and after coadministration of~     paracetamol.~   "
96574|NCT02303093|"~     Non-Interventional Study on the Tolerability and Efficacy of octagam® 10%~   "
96575|NCT02303080|"~     The main objective of the trial is to measure the thermogenic effect of two different doses~     of whey protein microgels.~      It will be a randomized crossover double-blind design conducted in 20 subjects.~   "
96576|NCT02303067|"~     Background:~      - This study is designed for people who need a standard, non-research invasive coronary~     angiogram to find out if they have heart disease. Researchers want to take a computed~     tomography (CT) scan of people s hearts before their procedure to see if this less invasive~     test can also diagnose coronary artery disease.~      Objectives:~      - To learn if a new way to view CT pictures is able to accurately diagnose coronary artery~     disease.~      Eligibility:~      - People age 55 and older who need a coronary angiogram.~      Design:~        -  Participants will be screened with their medical records.~        -  Participants may give a blood sample.~        -  Participants may have a CT scan of the heart with and without contrast. The CT scan will~          not interfere with their medical care.~        -  Participants blood pressure and heart rhythm will be monitored before, during, and after~          the CT scan. They may have an electrocardiogram.~        -  Before the scan, participants will have an intravenous catheter put into their arm. It~          will be used to inject contrast.~        -  Participants may take a beta blocker to slow their heart rate.~        -  Participants may take nitroglycerin under their tongue. It will enlarge their heart~          blood vessels and improve picture quality. It may cause a flushing sensation or~          headache.~        -  Participants will lie on their back on a padded table. The table slides into a large,~          donut-shaped machine. An x-ray tube will move around their body, taking pictures. They~          will be asked to hold their breath for 5 seconds at a time.~        -  Participants will be called 30 days after their angiogram. They will answer questions~          about their health, hospital visits, or medical treatments.~   "
96577|NCT02303054|"~     This is a prospective single center trial to examine the rate of negative biopsy result and~     quality of life after focal ablation by radiofrequency energy. The primary evaluation~     involves assessing the rate of negative biopsy result using MR-US fusion biopsy six months~     after focal ablation of the prostate. Urinary and sexual quality of life will be assessed~     through validated measures. The hypothesis of our study is that focal ablative therapy will~     result in a greater likelihood of negative biopsy on followup biopsy than that observed in~     men who elect not to undergo therapy.~   "
96578|NCT02303041|"~     This pilot trial studies how well sonidegib and buparlisib work in treating patients with~     basal cell carcinoma that has spread to other places in the body. Sonidegib and buparlisib~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
96579|NCT02303028|"~     This is a phase I, dose escalation study where topotecan will be administered at lower doses~     given more frequently on a prolonged schedule (low dose metronomic; LDM), in combination with~     a fixed dose of pazopanib. The maximum tolerated dose (MTD) and the recommended phase 2 dose~     (RP2D) will be evaluated for LDM topotecan in combination with pazopanib in children with~     recurrent or refractory solid tumours including CNS tumours. Pharmacokinetic and~     pharmacodynamic studies will be conducted to further define the exposure to and activity of~     LDM topotecan in combination with pazopanib.~   "
96580|NCT02303015|"~     The purpose of this study is to identify genetic variations in survivors of testicular cancer~     and connect these variations to differences in risks of late effects.~   "
96585|NCT02302950|"~     Raltegravir is the first marketed strand-transfer inhibitor of HIV-1 that was FDA approved in~     2007. It is currently one of the preferred treatment regimens for HIV by the Department of~     Health and Human Services. It has become a widely used antiretroviral therapy option for HIV~     infected patients. It provides good tolerability and a favorable lipid profile for patients~     when compared to some other antiretroviral treatment options. Little data is reported about~     efficacy in a minority patient population. Moreover, data in an indigent minority population~     in the United States has not been aggregated before. Therefore this study will investigate~     the efficacy of raltegravir in minority women residing in Houston, TX who are HIV infected.~   "
96586|NCT02302937|"~     This study is carried out to determine if laparoscopic inguinal TEP repair of the hernia~     using a mesh carried out with only 1 port (hole) results in the reduction of post- operative~     pain and use of painkillers, shorter hospital stay and lesser complications than that carried~     out using conventional 3 ports.~   "
96587|NCT02302924|"~     There is no standardized method for evaluating the symptoms of influenza. A standardized~     instrument for measuring influenza symptoms, with appropriate scientifically derived content~     and construct validity would have value for public health in terms of use as a validated~     outcome measure in interventions to treat or prevent influenza. The instrument also could~     serve as part of an overall measure of severity of illness in influenza. Previous efforts in~     participant reported outcomes (PRO) for influenza (i.e. Flu-PRO Stage I and Stage II) focused~     on the elicitation and evaluation of items for inclusion in the instrument. The overarching~     objective of this protocol - Flu-PRO Stage III - is to conduct instrument validation to~     evaluate item properties and, if need be, reduce the number of items, and quantitatively~     validate the performance of the final measure.~   "
96588|NCT02302911|"~     This study aims to investigate the effectiveness of early (before the age of 5 years) and~     intensive intervention for children with Autism Spectrum Disorders.~   "
96589|NCT02302898|"~     This study compares eating behaviors, meal size, and the size of the gastric pouch and~     connection between the gastric pouch and small intestine in patients who had gastric bypass~     surgery two or more years ago and regained weight compared with patients who had gastric~     bypass surgery two or more years ago and maintained their weight loss.~   "
96590|NCT02302885|"~     Human blood will be collected to serve as control in validating clinical studies studying the~     detection and levels of circulating tumor cells and microvesicles in cancer patients.~     Targeted population is cancer-free 18-60 year old men and women. Volunteer selection will~     rely upon a short health questionnaire. About 20 mL blood will be collected from volunteers~     up to 20 different timepoints. The Procedure involves minimal risk of harm (eg discomfort,~     bruising) to the volunteer.~   "
96591|NCT02302872|"~     The objective of the study is to evaluate the safety and performance of the ARTO System in~     patients with mitral valve regurgitation (MR) associated with congestive heart failure (CHF).~   "
96592|NCT02302859|"~     The goal of this research study is to learn about 2 different interactive methods that are~     designed to help people with HIV/AIDS stop smoking.~   "
96593|NCT02302846|"~     The goal of this clinical research study is to learn if ixazomib can prevent AML or MDS from~     coming back in patients who are in remission. The safety of this drug will also be studied.~   "
96594|NCT02302833|"~     The goal of this clinical research study is to learn if cabozantinib can help to control~     advanced or metastatic pheochromocytoma or paraganglioma. The safety of this drug will also~     be studied.~      This is an investigational study. Cabozantinib is FDA-approved and commercially available for~     the treatment of metastatic medullary thyroid cancer. It is investigational to give~     cabozantinib to patients with pheochromocytoma or paraganglioma. The study doctor can explain~     how the study drug is designed to work.~      Up to 22 participants will be enrolled in this study. All will take part at MD Anderson.~   "
96595|NCT02302820|"~     This study begins to look at ways nurses in primary care might help patients engage in~     Advance Care Planning and communicate their values and preferences to family and doctors.~   "
96596|NCT02302807|"~     This is a Phase III, global, multicenter, open-label, two-arm, randomized, controlled study~     designed to evaluate the efficacy and safety of atezolizumab compared with chemotherapy in~     participants with locally advanced or metastatic urothelial bladder cancer (UBC) who have~     progressed during or following a platinum-containing regimen. The anticipated time on study~     treatment is based on continued clinical benefit, i.e., until disease progression or~     unacceptable toxicity. The target sample size is 931 participants.~   "
96597|NCT02302794|"~     evaluate the long-term efficacy and safety of oncology between D2 laparoscopic approach~     distal gastric resection (distal gastrectomy, D2 lymph node dissection) with the current~     standard surgical treatment model D2 open approach distal gastric resection (distal~     gastrectomy, D2 lymphadenectomy).~   "
96598|NCT02302781|"~     Dropout rates for fertility treatments are high. This study will examine the rate of patients~     that drop out during any type of subfertility work up or treatment. Furthermore, we will~     determine what reasons for discontinuation are and we will identify the demographic~     characteristics of the couples and the prognostic factors for drop out during assessment or~     treatment at a Fertility Centre in the Isala (Zwolle), Erasmus University Centre (Rotterdam),~     Elisabeth Twee Steden Hospital (Tilburg), Reinier de Graaf Group (Voorburg), St Antonius~     Hospital (Nieuwegein), Maxima Medical Centre (Veldhoven) and Noordwest Hospital Group (Den~     Helder/Alkmaar) in The Netherlands.~   "
96599|NCT02302768|"~     Over the past 10 years, several clinical studies have suggested that selenium supplementation~     may influence the natural history of AIT. Recently, Interferon gamma (IFNγ)-inducible~     chemokines (CXCL-9, -10 and -11) were shown to be elevated in the AIT patients. The aim of~     this prospective, randomized, controlled study is to evaluate the effect of two different~     doses of selenomethionine (80 or 160 mcg) versus placebo in euthyroid women with AIT, in~     terms of reduction of anti-thyroid antibodies and improvement of thyroid hypoechogenicity,~     over 24 months. Serum levels of selenium, CXCL-9, -10 and -11 and their regulators, Tumor~     necrosis factor alpha (TNFα) and INFγ, thyroid function and volume and the quality of life of~     AIT patients are also evaluated.~   "
96600|NCT02302755|"~     The purpose of this study is to evaluate the safety of repeated TP10 dosing in pediatric and~     adult patients with C3G and to evaluate the activity of TP10 in pediatric and adult patients~     with C3G, as measured by the proportion of patients with normalization of serum C3, serum C3~     breakdown products, or alternative pathway (AP) complement activity.~   "
96602|NCT02302729|"~     Over 200 million children under the age of 5 years in low and middle-income countries do not~     reach their developmental potential, largely due to lack of adequate nutrients and lack of~     psychosocial stimulation. Stunting (length-for-age < -2 z-scores) is an indication of chronic~     undernutrition. Guatemala has the high rates of stunting in the Western Hemisphere (over~     40%). This trial examines the effect of providing a micronutrient powder manufactured in~     Guatemala vs. placebo and an early learning environment vs. no early learning environment on~     the growth, health, and development of young children in Guatemala.~   "
96603|NCT02302716|"~     The main purpose of this study is to evaluate the safety and efficacy of the study drug known~     as LY2963016 as compared to LANTUS® in adults with type 2 diabetes mellitus who are on 2 or~     more oral antihyperglycemic medications (OAMs).~   "
96604|NCT02302703|"~     Background: IBS (irritable bowel syndrome) describes chronic abdominal pain, which may be~     relieved with defecation and a change in stool frequency and consistency. Its prevalence~     among children and adolescents is estimated to be 10-15%. Non-Celiac Gluten Sensitivity is~     defined as gastrointestinal symptoms which increase with eating gluten-containing foods and~     improve with a gluten-free diet. FODMAP (fermentable oligo-,di-,mono-saccharides and polyols)~     are carbohydrates that are not absorbed well in the small intestines, therefore fermented by~     gut microbiota, increasing osmotic load at the intestine causing fluid shift and gas~     production. The patient suffers bloating, abdominal pain, flatulence and change of stool~     consistency. Many foods are FODMAP-rich, including fruit and vegetables, legumes, artificial~     sweeteners and soft drinks.~      Working hypothesis and aims: To study the effect of Low FODMAP diet vs. Gluten free on~     gastrointestinal symptoms in children with IBS, assuming a beneficial effect based on~     research in adults.~      Methods: 40 children with IBS, aged 6-18 years, will be examined by the pediatric~     gastroenterology team at Hadassah. All children will record one week of baseline diet and~     symptoms, then will be randomly selected into a low-FODMAP or Gluten-free diet for one week,~     together with a washout period of one week between the diets. During the two weeks of~     intervention diets, the children aided by their parents will document and score symptoms~     (bowel movements, abdominal pain, flatulence). An analysis of the symptom score will measure~     the anticipated influence of each diet against baseline diet and symptoms.~      Expected results: In previous studies, a change in symptoms was viewed within a few days. We~     expect to see a reduction of symptoms in one or other of the diets, to prove our hypothesis.~   "
96605|NCT02302690|"~     The proposed research protocol aims at addressing these points by pre-screening CN patients~     for their AAV serology in link with their medical history and current medical status. A first~     objective is to assess the presence of neutralizing AAV antibodies in the serum of CN~     patients.~   "
96606|NCT02302677|"~     This is a prospective study of meal-induced bile acid physiology before and after sleeve~     gastrectomy (SG) surgery. Weight loss and metabolic improvement associated with weight loss~     surgery cannot be entirely attributed to restriction in stomach size and food intake. Bile~     acids (BAs), amphipathic steroids that have a role in lipid uptake and metabolism in the~     gastrointestinal tract, are involved in post-prandial glucose homeostasis and energy~     expenditure, and are a potential intermediary in weight loss following bariatric surgery. It~     is unknown if SG increases post-prandial BAs in humans and if an increase in BA signaling~     impacts weight loss and co-morbidity resolution after surgery. The investigators hypothesis~     is that SG will increase the post-prandial serum and urine BAs and that the change in the BA~     profile is a mechanism for restriction-independent weight-loss following SG. 32 eligible,~     adult, morbidly obese human subjects will be recruited by the Clinical Research Center at~     UNMC. These subjects will be evaluated in a multi-disciplinary fashion, approved, and~     consented to have a SG at UNMC. Subjects will be eligible for the study if they meet these~     criteria: between 19 and 70 years old, participant in the Surgical Weight Loss Program of the~     Bariatrics Center of University of Nebraska Medical Center (UNMC), approved to have a SG at~     UNMC, have SG as the primary bariatric surgery or prior lap band placement and removal over~     two years prior to the surgery. Medical charts of participants will be reviewed and pertinent~     data from time of surgery will be abstracted. Subjects will be excluded from the study if~     have a past history of small bowel resection or right colectomy, cirrhosis, current or~     planned use of BA sequestrants, or bariatric surgery performed as a revisional procedure. SG~     patients will undergo a meal challenge pre-operatively, and at 1, 3, and 12 months~     post-operatively, with measurement of post-prandial serum and urine BAs and downstream~     hormones, glucagon-like peptide 1 (GLP-1) and fibroblast growth factor 19 (FGF19), and a~     scoring of satiety before and after the meal challenge using a Visual Analog Scale. Serum~     insulin, glucose, and C4 levels will also be measured to assess metabolic changes associated~     with SG. Serum and urine BA levels will be compared to post-operative excess weight loss at~     12 months. Before and after each meal challenge, patients will be asked to score satiety, and~     this will be correlated to weight loss, bile acids, GLP-1, and FGF19.~   "
96607|NCT02302664|"~     Platelet Rich Plasma in Achilles Tendon Healing~      Does using a Platelet Rich Plasma (PRP) injection immediately before standard casting benefit~     patients aged 18 or over who are suitable for nonsurgical treatment of the Achilles tendon~     rupture (ATR)? This is a multicentre, blinded, randomised, placebo controlled trial with two~     sub studies: (1) blood sample analysis and (2) needle biopsy in 16 participants.~      ATR is the most common tendon injury and leads to months of incapacity. With an average work~     absence of 63108 days there are significant societal and National Health Service (NHS) costs.~     PRP potential benefit is to improve recovery and return to normal activities earlier, and~     reduce the NHS and societal impact. The investigators will investigate the efficacy of PRP~     using disease specific and patient important outcomes to improve the evidence for this~     treatment of ATR.~      A minimum of 15 United Kingdom (UK) NHS hospitals will be included to recruit 214~     participants. Patients will be identified in the orthopaedic outpatient clinic, usually~     following an emergency hospital attendance for ATR. After checking eligibility and the~     informed consent process, baseline data is collected and participants randomised to either~     'PRP injection' or 'Imitation (placebo) injection'. A participant's own blood sample is taken~     and prepared according to allocation. The injection is delivered by a trained surgeon in~     clinic who will be aware of allocation while the participant remains blind.~      Participants complete a pain diary and have four study assessments at 4,7,13 and 24 weeks,~     carried out by a member of the research team blind to allocation. Assessments take place over~     the telephone or during a hospital outpatient visit. The 24 week hospital visit includes an~     exercise test of ankle function. All assessments include collection of patient reported~     responses to pre-set questions.~      The results may be applicable to the many other tendon and ligament injuries. The National~     Institute for Health Research (NIHR)/Medical Research Council (MRC) Efficacy and Mechanism~     Evaluation Programme provides funding and University of Oxford is Sponsor.~   "
96608|NCT02302651|"~     Non-invasive treatment of Osteoid osteoma using MRI guided high-intensity focused ultrasound.~     This study is designed as an intention-to-treat using a totally non-invasive approach for~     pain reduction, quality of life improvement and long-term bone restoration. Procedure is~     performed in a single session using limited amount of acoustic energy to target the osteoid~     nidus. Treatment will be performed under anesthesia (peripheral or general according to age~     and lesion position).~   "
96609|NCT02302638|"~     This prospective study with sibling oocytes will evaluate the efficiency of two commercial~     single-step media, namely Sage 1-step and Continuous Single Culture Medium (CSCM), in terms~     of embryo utilization rates, blastocyst formation rates, embryo quality and pregnancy rates.~     Embryos will be cultured continuously for up to 6 days under identical conditions.~   "
96610|NCT02302625|"~     Atopic dermatitis is an inflammatory skin disease characterized by itching, dry skin and~     recurrent inflammatory eczema. It is one of the most common skin diseases and is associated~     with reduced quality of life, functional impairment and sleep difficulties. The present study~     aims to investigate a new exposure-based cognitive behavioral psychological treatment for the~     disorder. The trial is a small scale open trial (n=25) with assessments at baseline,~     post-treatment and 6-month follow-up. The primary outcome is the SCORAD.~   "
96611|NCT02302612|"~     Cardiovascular disease (CVD) is the leading cause of death in the U.S. Efforts to improve CVD~     risk factors often fall short in complex patients with multiple co-morbid conditions, a~     growing, expensive, and high-risk segment of the U.S. population. The investigators are~     testing a multi-component behavioral intervention designed to help complex patients with CVD~     and other concurrent chronic conditions to become more effective agents of their own care.~   "
96612|NCT02302599|"~     Between umbilical cord mesenchymal stem cells by the secretion characteristics, secrete a~     variety of cytokines and its immune inhibition, promoted the islet cell repair and~     regeneration, improve the state of high blood sugar in the body.~   "
96613|NCT02302586|"~     Video-assisted thoracoscopic surgeries (VATS) include severe postoperative acute pain which~     is also a predictor of chronic pain. In this study, the investigators aim to compare the~     postoperative effects of thoracic paravertebral block (TPVB) and intravenous patient~     controlled analgesia (PCA) on the prevention of chronic pain of patients undergoing VATS.~   "
96614|NCT02302573|"~     Abnormally invasive placenta (AIP) is defined as an abnormal placental attachment of a part~     or the entire chorionic plate with penetration of chorionic villi in the myometrium and~     absence of the decidua basalis. This anomaly is associated with significant maternal~     morbidity and mortality as it may result in severe haemorrhage during the post-partum. It has~     been demonstrated that prenatal diagnosis of AIP is essential to reduce maternal morbidity.~     In a recent study of Chantraine F. et al. prenatal diagnosis of AIP leads to better outcomes,~     due to fewer emergency operations and less mass transfusions. Currently, the diagnosis of AIP~     is based on a combination of conventional B-mode ultrasound and MRI. However, prenatal~     diagnosis of AIP remains challenging and recent reports demonstrated it is achieved in only~     thirds of cases.~      Contrast enhanced ultrasound (CEUS) is a non-invasive technique based on the detection by~     ultrasound (US) of gas-filled microbubbles used as perfusion tracers. Intravascular~     rheological properties of these bubbles are similar to those of red blood cells and they~     remain entirely within the intravascular space. Previous studies have demonstrated that~     microbubbles do not transfer into fetal circulation. CEUS has been used for years in many US~     imaging applications (e.g. liver, kidneys and breast). In obstetrics, despite not yet~     approved for clinical use, CEUS offers the opportunity to analyze anatomical placental~     landmarks, improving the contrast between placenta and myometrium. In addition,~     quantification parameters related to the contrast enhancement have been proposed as objective~     indicators to estimate blood perfusion rates in the placental intervillous space.~      The main objective of this study is to provide pre-clinical evaluation of CEUS for the~     diagnosis of AIP and to try to determine if AIP are characterised by differences in~     intervillous blood rheological properties. Conventional CEUS parameters will be: rise time,~     peak enhancement, wash-in rate, mean transit time and wash-in area under the curve.~      As this study is a pre-clinical evaluation, sample size calculation remains subjective and~     imprecise. For this reason, a sample size of 100 pregnant women to be included in this~     prospective study has been decided.~      The potential impact of this study will be to propose a more reliable tool with both improved~     sensibility and specificity compared to the combination US/MRI and therefore to reduce the~     maternal worldwide burden of AIP.~   "
96615|NCT02302560|"~     The purpose of this prospective observational study is to investigate the changes in sleep~     architecture after a hip surgery and its potential association with postoperative delirium~     and postoperative cognitive dysfunctions respectively.~   "
96616|NCT02302547|"~     In the early 2000s, the TRILEGE© study was realized to determine if the reductive anti~     retroviral strategy from an initial triple therapy (based on a protease inhibitor as the~     third agent) towards a dual therapy of nucleoside analogs (in particular the association of~     zidovudine +lamivudine) for patients infected by HIV and stabilized for at least 3 months~     at a threshold value of 400 copies/ml, would allow to obtain a well-controlled plasmatic~     viral load, with an aim to reduce the long-term side effects of the treatment.~      The afore mentioned study showed that the reductive anti retroviral strategy was a failure.~     No study has as yet to revaluate this strategy, in particular in the current context of~     antiretroviral treatments.~      Indeed, modern nucleoside inhibitors (Kivexa®, Truvada®) have extended half-lives as well as~     a superior intrinsic power as compared to treatments proposed in the initial TRILEGE©~     study. Furthermore, the better quality of current triple therapy (as compared to that used 10~     years ago) has lead to substantial viral reservoir reduction.~      Currently, a small number of patients is being successfully treated in the long-term (viral~     load < 20 copies/ml) using nucleoside analog dual therapy. The particular characteristics of~     these patients have yet to be thoroughly investigated.~      The patients concerned were all treated prematurely before ever passing below 200 lymphocytes~     T CD4/mm3. It occurred that all these patients presented a low viral reservoir as measured by~     HIV DNA quantification (< 2,7 log copies/106 PBMC).~      Therefore, by targeting patients who have (1) a strong immune restoration, (2) a low HIV DNA~     value and (3) a very good observance, the investigators emit the hypothesis that, reductive~     anti retroviral strategy that would consist in changing from a conventional triple therapy~     towards a Nucleoside reverse-transcriptase inhibitors dual therapy, could allow for durable~     control of viral replication with the concomitant benefice of reduced antiretroviral side~     effects and cost.~   "
96617|NCT02302534|"~     Adolescent idiopathic scoliosis (AIS) is a complex deformity with different curves. These~     different curves may be distinguished by different physiopathologic mechanisms.~      Without fully convincing model of the emergence and development of AIS, their multifactorial~     nature seems evident. Several pathophysiological theories involving the central nervous~     system have been proposed: the AIS would be associated with disturbances of proprioceptive or~     sensory perception, and/or with integration of this information. This would result in an~     abnormal body image, responsible for sensorimotor asymmetry that may promote or cause the~     deformation.~      The Main aim of this study is to find cortical and subcortical morphometric differences in~     the most common population of AIS (right thoracic AIS) compared to healthy adolescent control~     girls.~      Secondary Objectives are to study the cerebral white matter of the same groups (fractional~     anisotropy in the main white matter tracts), and activation of sensorimotor neural networks~     (fMRI activation and functional brain connectivity).~      Abnormalities of the studied parameters may be used as biomarkers for AIS diagnosis and~     classification.~   "
96618|NCT02302521|"~     The purpose of this study is to evaluate our recently developed MRI reconstruction strategy~     for producing artifact-free neuro and abdominal MRI data. The new reconstruction strategies,~     including 1) REKAM and 2) MUSE, are capable of effectively removing motion-related artifacts~     resulting from global and local motion during neuro and free-breathing abdominal MRI scans,~     without modifying the MRI pulse sequences and protocols that are currently used in clinical~     scans. The study team aims to recruit 60 subjects across multiple challenge patient~     populations: 10 healthy young adults (age 20-30) and 10 healthy older adults (aged 50-70) for~     abdominal MRI, as well as 20 tremor dominant PD patients and 20 children (age 4-8) for brain~     MRI scans. There are no known risks in taking MRIs and a unique code will be assigned to each~     participant to protect their PHI.~   "
96619|NCT02302508|"~     Clopidogrel efficacy appears diminished in patients with type 2 diabetes (T2D) who continue~     to show an increased risk of adverse cardiovascular events and mortality compared to those~     without T2D.The aim of the first project is to describe the pharmacokinetic (PK) profile of~     three antiplatelet drugs in 4 groups of patients according to their diabetic or non-diabetic~     status. To this end, PK profiles will be determined after a single oral dose of 300 mg~     clopidogrel, 60 mg prasugrel and 180 mg ticagrelor in patients (n=108); 1) with T2D and good~     glycemic control; 2) with T2D and poor glycemic control; 3) with insulin-treated diabetes;~     and 4) non-diabetic subjects.~   "
96620|NCT02302495|"~     IFM 2012-03 protocol is a Phase 2 multicenter nonrandomized open in elderly patients with~     multiple myeloma at diagnosis. Study primary objectives are in the first step to determine~     Maximum tolerated dose (MTD) of Carfilzomib Weekly based on definition of Dose-limiting~     toxicities (DLTs) and in the second step to expanded cohort, to determine the VGPR (Very Good~     Partial Response) + CR (Complete Response) rate of Carfilzomib Weekly at the MTD in~     combination with Melphalan Prednisone at the end of the 9 induction cycles.~   "
96621|NCT02302482|"~     The Alzheimer's disease or related disorders (ADRD) are among the most disabling diseases~     because of their main features such as cognitive impairment, loss of functional autonomy and~     behavioural disorders. In absence of current curative treatment, the identification of the~     predictive risk factors of progression of the disease, evaluated through its main symptoms,~     represents a major stake of public health. The investigators aimed at developing a database,~     which includes the patient medical records on a prospective basis, in collaboration with the~     medical and administrative personal and with the University hospital computer science~     department. The main objective is to study the predictive factors associated with the change~     of functional autonomy level, measured every 6 months to 12 months by phone, in a Memory~     Clinic. The study population would consist in about 1000 patients with ADRD. The length of~     follow-up of each patient will be 3 years.~   "
96622|NCT02302469|"~     The purpose of this study is to determine the recommended dose of lenalidomide in subjects~     with relapse and refractory Waldenstrom Macroglobulinemia.~   "
96623|NCT02302456|"~     The purpose of this study is to assess whether the administration of a low dose of tranexamic~     acid just after vaginal delivery can reduce the incidence of immediate postpartum hemorrhage,~     in women who receive a prophylactic administration of oxytocin.~   "
96624|NCT02302443|"~     The purpose of this study is to investigate safety, tolerability, pharmacokinetics (PK) ad~     pharmacodynamics (PD) of HM12470 after single injection in T1DM and T2DM patients.~   "
96625|NCT02302430|"~     This study attempts to identify the psychological, behavioral, physiological, and hormonal~     predictors and mechanisms of an individual's ability to develop cohesion in a group working~     together as a team; and examine if administration of the prosocial neuropeptide oxytocin~     enhances the development of team cohesion. Through a deeper understanding of the underlying~     psychobiological predictors and mechanisms of team cohesion, the prospective identification~     of individuals whose unique characteristics promote or inhibit the development of group~     cohesion will become possible.~   "
96626|NCT02302417|"~     The primary objective of the study is to identify demographic and non-spirometric clinical~     features predictive of the asthma-COPD overlap population. The study aims to explore and~     identify characteristics of the Asthma-COPD Overlap Syndrome (ACOS) patient's clinical~     profile that enable clinical differentiation from subjects with a primary diagnosis of either~     asthma alone (without persistent obstruction) or COPD alone (without reversibility). The~     study is designed as a targeted medical history survey which consists of a 41-item~     questionnaire, which will be administered by a qualified health care practitioner at the time~     a subject's medical history is taken. The questionnaire has been developed to elicit specific~     details of the respiratory history, including the following: bronchodilator use, disease~     progression, variation in symptoms, atopic history, symptom triggers, vagal bias, burden of~     disease, symptom presentation, co morbidities and age of onset. In addition, demographic~     information, standard medical history, co morbidity and spirometric results will also be~     obtained and analyzed in conjunction with the questionnaire results. Approximately 1000~     subjects are required for the study.~   "
96627|NCT02302404|"~     This study is the first administration of GSK2982772 in humans. The study will evaluate the~     safety, tolerability, pharmacokinetics (PK), and exploratory pharmacodynamics (PD) of single~     and repeat oral doses of up to 14 days with GSK2982772 in healthy male subjects.~      This study is planned to include approximately 52 subjects and will consist of 2 parts: Part~     A - single ascending dose, randomized, placebo controlled, 4 way crossover. In addition to~     the crossover treatment periods, up to 8 subjects in cohort 2 will participate in an~     additional treatment period and receive GSK2982772 with a high-fat meal. Part B - repeat~     dose, randomized, placebo controlled, sequential-group. In both cohorts of Part A (Cohorts 1~     and 2), subjects will be randomized equally (1:1:1:1) to one of 4 treatment sequences. Within~     each period, allocation of active to placebo treatment will be 3:1.~      In all cohorts in Part B (Cohorts 3, 4 and 5) subjects will be randomized to GSK2982772 or~     placebo in a 3:1 ratio. If required, subjects in the additional cohorts in Part A (Cohort 6)~     and Part B (Cohort 7) will be randomized to GSK2982772 or placebo in a 1:1:1:1 and 3:1 ratio,~     respectively. The study duration, including screening and follow-up, is not expected to~     exceed 105 days for any subject in the study.~   "
96628|NCT02302391|"~     Pharmacokinetic monitoring of midazolam, it's active metabolite and fentanyl in pediatric~     patients with long-term analgosedation will be performed. Especially, the chronologic~     sequence of the quantified plasma levels during sedation and during wake-up as well as the~     correlation to dose and sedation depth will be focused.~   "
96629|NCT02302378|"~     Spinal anesthesia is a common technique for providing anesthesia for knee joint replacement~     surgery. The investigators wish to demonstrate that using a lower approach to spinal~     anesthetic (Taylor's approach of L5-S1) causes less low blood pressure while still providing~     adequate anesthesia for knee joint replacement surgery than a higher approach (L3-L4).~   "
96630|NCT02302365|"~     This study is a multicenter, retrospective data collection of routine clinical use with the~     Spectra Optia® apheresis system for white blood cell depletion.~   "
96840|NCT02299622|"~     The next generation of personalized medical treatment according to the type of personal~     genetic information are evolving rapidly. The genome analysis needs systematic infra and~     database based on personal genetic information Therefore, a big data of genome-clinical~     information is important.~   "
96631|NCT02302352|"~     Systemic sclerosis (SSc) is an autoimmune disease with unknown etiology, which affects~     especially the gastrointestinal tract, lungs, heart and kidneys. Immunological abnormalities~     characterized by innate and acquired immune disturbances are associated with the disease~     development. The present study aims to evaluate the efficacy and safety of probiotics in~     gastrointestinal symptoms, nutritional status and innate and acquired immune responses, by~     means of the evaluation of IgA, Treg and Th1, Th2, and Th17 T helper subtypes levels in~     patients with SSc. In addition the levels of CD4+ T helper Th1, Th2 and Th17 subtypes and~     Treg levels will be compared to a healthy control group.~   "
96632|NCT02302339|"~     This study will examine the effectiveness and safety of glembatumumab vedotin as monotherapy~     or in combination with immunotherapies in patients with advanced melanoma.~   "
96633|NCT02302326|"~     The main objective of the present project is to evaluate the relevance of reticulum stress in~     the pathogenesis of polycystic ovary syndrome (PCOS), focusing particularly on the underlying~     mechanisms of insulin resistance, which is the origin of metabolic comorbidities.~     Furthermore, the investigators will assess the potential of insulin sensitizers as a~     treatment to control endoplasmic reticulum stress markers in PCOS patients.~   "
96634|NCT02302313|"~     Healthy subjects should assess pain on a numerical scale (EN), during painful skin stimuli of~     variable intensity delivered by a CO2 laser used at the power of 0.3 W, known for its safety.~     ANI (Analgesia Nociception Index) will be raised simultaneously. This sequence will be made~     on subjects at rest and in a state of hypnosis using the technique of remembering a pleasant~     memory and the ideo-sensory technique of protective glove.~      The average value of the ANI will be compared to the value of the EVN of pain intensity.~   "
96635|NCT02302300|"~     After cardiac surgery, many complications can arise, in particular at the cardiac and lung~     level and it is true especially as the patient is with comorbidity. A patient will be~     considered at risk of a cardiac surgery if risk factors are present in preoperative (obesity,~     Chronic obstructive pulmonary disease (COPD), etc...). The non-invasive ventilation~     (NIV)developed these last years in the treatment of acute cardiac insufficiency and the~     hypercapnic COPD exacerbations; its use is more and more envisaged in cardio-thoracic and~     abdominal surgery services.~      Studies showed that the NIV allowed an improvement of the oxygenation, the lung volumes and a~     decrease of ventilation work. According to these observations, the preventive NIV could~     reduce the incidence of appearance of the lung and/or cardiac complications at the patients~     to risk. we estimate 40 to 50%of cardiac surgery patients at a high risk level and we expect~     to obtain a benefit with this particular population. If we meet our goal (a significant~     difference in terms of morbi-mortality with the preventive NIV versus classical care), we~     expect the systematisation of this procedure to all cardiac surgery high risk patients.~   "
96636|NCT02302287|"~     Food intake has a deep influence on gut microbiota composition and function, both in health~     and in disease status. In chronic kidney disease (CKD), a microbiota dysbiosis status is~     observed. Moreover, many toxic uremic molecules are microbial-derived and their accumulation~     promotes, in turn, disease progression.~      Investigators' hypothesis foresees a beneficial effect of nutritional treatments, able to~     restore gut microbiota balance, to lower microbial-derived uremic toxins and to improve~     clinical conditions in CKD patients.~      Mediterranean Diet (MD) is supposed to have beneficial effect on microbiota composition,~     while low-protein diet supplemented with ketoacids (KD) is used in CKD patients for the~     improvement of clinical conditions, but its effects on gut microbiota are currently unknown.~     Investigators' project aim is to verify the effects of MD and KD on: microbiota and~     metabolome composition, microbial-derived uremic toxins level and clinical conditions in a~     cohort of CKD patients.~   "
96637|NCT02302274|"~     The study aims to use flecainide infusion test as diagnostic test to unmask concealed Brugada~     Syndrome cases. It proposes to assess the safety profile of this test in US patients and its~     higher sensitivity when compared to procainamide infusion (the conventional drug used in the~     USA). As a substudy it proposes to apply this test to early ARVC cases in order to evaluate~     if ECG changes similar to those seen in Brugada Syndrome could be unmasked by flecainide iv.~   "
96638|NCT02302261|"~     Research has shown that pleth variability can be used to assess asthma severity in children~     with status asthmaticus. The investigators would like to use an FDA-cleared monitor (Masimo~     Radical 7) which measures Pleth Variability Index (PVI) to see if the degree of PVI can be~     used to help triage patients who present to the pediatric ED in status asthmaticus.~   "
96639|NCT02302248|"~     This study evaluates a web-based, crowdsourcing platform to promote cognitive reappraisal.~     Half of participants will be granted access to the crowdsourced reappraisal platform. The~     other half will be provided a web-based expressive writing platform. The investigators~     hypothesize that the crowdsourcing reappraisal platform will be more effective than the~     expressive writing platform in promoting positive psychological outcomes.~   "
96640|NCT02302235|"~     The goal of the present study is to evaluate efficacy, safety and tolerability of 4:1~     ketogenic diet administered adjunctively to standard radiation and temozolomide chemotherapy~     in patients with GBM in a prospective, randomized open label study.~   "
96641|NCT02302222|"~     The goal of this study is to evaluate the impact of Customizable in the management of~     extensive closed surgical incisions for Subjects undergoing abdominal surgery for incisional~     hernia repair and/or functional panniculectomy as compared to SOC dressing, and to~     significantly reduce the SSC rate experienced by Subjects receiving Customizable vs. SOC~     surgical incision dressing.~   "
96642|NCT02302209|"~     The purpose of the investigators proposed study is twofold: 1) To investigate the role of the~     affiliative neuropeptide oxytocin in unhealthy interactions in families of patients with~     schizophrenia and families of patients with autism spectrum disorder, and 2) to investigate~     whether manipulation of this oxytocinergic system positively influences these family~     interactions.~   "
96643|NCT02302196|"~     The purpose of the study is to evaluate the safety and efficacy of breast reconstruction~     using Autologous Fat Grafting (AFG) for women post lumpectomy that have contour defects.~      The study hypothesis is that AFG has emerged as a less invasive alternative to breast~     reconstruction post mastectomy. AFG could be used to treat breast contour defects with much~     less invasive outpatient surgery, using the patient's own cells and tissues, which overall~     reduces risk.~   "
96644|NCT02302183|"~     The aim of the study is to assess the use feasibility of the FreeO2 system so as to deliver~     automatically oxygen in infants and children admitted at hospital for hypoxemic acute~     respiratory distress.~      In healthy volunteers adults, FreeO2 system provided a better control of the oxygen~     saturation in function of designed target, reducing the desaturation time and hyperoxia. Our~     hypothesis is that FreeO2 system use is feasible in infants and children with hypoxemic acute~     respiratory distress. We think FreeO2 will provide a better control of the oxygen saturation,~     a faster oxygen weaning than classical way (Rotameter). In addition, FreeO2 could reduce the~     number of intervention by nurses.~   "
96645|NCT02302170|"~     Helicobacter pylori (H. pylori) is a Gram-negative, microaerophilic bacterium that~     persistently colonizes the human stomach; more than half the human population is infected~     worldwide. H. pylori infection is a risk factor for the development of gastritis, peptic~     ulcer, gastric mucosa-associated lymphoid tissue lymphoma, and gastric cancer.~      The phaseⅠand Ⅱclinical trial of oral recombinant Helicobacter pylori vaccine had completed~     in Jiangsu Province in China. The data from phaseⅠand Ⅱclinical trial suggested that the oral~     recombinant Helicobacter pylori vaccine had a clinically acceptable safety and good~     immunogenicity for health adults and children. To further explore the safety and~     immunogenicity profile of this vaccine, a phase Ⅲ clinical trial was conducted.~   "
96646|NCT02302157|"~     The purpose of this study is to evaluate the safety of cross sequential escalating doses of~     AST-OPC1 administered among 5 cohorts at a single time-point between 21 and 42 days post~     injury, inclusively, to subjects with subacute cervical spinal cord injuries (SCI).~   "
96647|NCT02302144|"~     The primary objective of this study is to investigate the effects of a theoretically driven,~     highly challenging exercise program (balance and strengthening exercises) in reducing fall~     rate, improving balance and reducing fear of falling in persons with Parkinson's disease.~      In this pilot, randomized, cross-over study, 32 participants with Parkinson disease will be~     randomly assigned to either an early start (immediately following enrollment) or late start~     (3 months after enrollment) multifactorial exercise program which will meet 2 times per week~     for 1.5 hours over 3 months. The exercise program will consist of balance and strengthening~     exercises which will be individualized depending on the ability of each participant. Fall~     rate, balance, walking ability, fear of falling, mood, anxiety, and quality of life will be~     measured prior to the start, at 3 months and 6 months after enrollment. Subjects will be~     enrolled for 6-7 months.~   "
96648|NCT02302131|"~     Multi-center, Observational Registry with Retrospective Enrollment and Prospective Follow-up.~      The aim of the registry is to document the feasibility and safety of implanting an Edwards~     SAPIEN XT transcatheter heart valve in the pulmonic position.~   "
96649|NCT02302118|"~     Comparison of the oncological outcome of patients who underwent esophagogastrectomy versus~     extended gastrectomy due to carcinomas of the esophagogastric junction (Siewert type II)~   "
96650|NCT02302105|"~     Evidence to justify the use of the pelvic field is lacking for men with high risk localized~     prostate cancer. An additional randomized study is needed in men with a potential risk of~     nodal involvement to test the hypothesis that the use of the pelvic field contributed to the~     benefit observed in those studies.~      This trial aims to compare the outcomes with whole pelvis RT and Prostate alone RT in~     patients with High risk, non metastatic Prostate cancer with a Lymph nodal >20% with Primary~     4 year Biochemical failure free survival and Secondary Disease free survival, overall~     survival, Acute toxicity, Late toxicity and QOL Patients will be randomized to one of two~     arms Arm 1 Whole pelvis radiotherapy and Arm 2 Prostate only radiotherapy. The Dose~     prescription will be 66 Gy in 25 fractions will be prescribed for the prostate PTV in Arm 2~     an additional 50 Gy in 25 fractions for nodal PTV in patients in Arm 1. An overlap volume at~     rectal-prostate interface will receive 64 Gy/25#.~      All patients will receive hormone therapy starting at least 8 weeks prior to the beginning of~     radiotherapy. They will continue the hormone therapy and later for a total duration of 2-3~     years.~   "
96651|NCT02302092|"~     The purpose of this study is to compare the effectiveness of antibiotic flomoxef with~     cefepime for the treatment of complicated urinary tract infections (cUTIs) in Russian adults.~   "
96652|NCT02302079|"~     The purpose of this study is to evaluate efficacy and safety of ASP8232 in subjects with~     diabetic macular edema (DME). This study will evaluate the percent change from baseline in~     excess central subfield thickness (CST) in the study eye as assessed by spectral~     domain-optical coherence Tomography (SD-OCT) for ASP8232 monotherapy at Month 3.~   "
96653|NCT02302066|"~     The purpose of this study is to assess the humoral immune responses to Takeda's Tetravalent~     Dengue Vaccine Candidate (TDV) administered subcutaneously in a subset of healthy~     participants between 2 and <18 years of age living in dengue endemic countries.~   "
96654|NCT02302053|"~     The New Viviscal Professional Strength is an oral food supplement specifically designed to~     promote hair growth for women suffering from temporary thinning hair. It does not contain~     hormones, drugs or industry by-products. Viviscal has been marketed in Europe for over 15~     years.~      The purpose of this clinical research study is to evaluate certain physiological effects of~     Viviscal compared to placebo in forty (40) female subjects, ages 21-75 years of age with~     self-perceived thinning hair associated with poor diet, stress, hormonal influences or~     abnormal menstrual cycles when compared to using the placebo tablet.~   "
96655|NCT02302040|"~     The aims of this application are to develop and test AIM2ACT, a mobile health (mHealth) tool,~     delivered via smartphones, that fosters helpful caregiver support as early adolescents (ages~     12-15) with persistent asthma develop and master asthma self-management behaviors. To~     facilitate helpful caregiver support, AIM2ACT uses mHealth technology to determine tailored~     intervention targets for each family. AIM2ACT then helps caregiver/adolescent dyads set~     asthma management goals by automatically guiding families through a structured process that~     includes the supportive behavioral management strategies of goal setting, contingency~     management, and problem solving communication. Skills-training videos for adolescents and~     caregivers provide guidance on how to complete each collaborative asthma management~     component.~      AIM2ACT will be developed through feedback from an advisory board of adolescent-caregiver~     dyads from the target user population and a pediatric pulmonologist. Following advisory board~     feedback, the investigators will conduct a pilot randomized controlled trial of AIM2ACT with~     50 early adolescents with poorly controlled asthma, ages 12-15 years, and a caregiver.~     Families will be randomly assigned to receive AIM2ACT or a self-guided condition for a 4~     month intervention period. Participants in the self-guided condition will be given general~     information on supportive behavioral management techniques they can use to target improvement~     in asthma self-management behaviors. Outcomes include whether participants prefer AIM2ACT or~     the self-guided condition. Additionally, AIM2ACT and the self-guided condition will be~     compared to see if there are differences in changes in family asthma management (primary~     outcome), lung function, asthma control, asthma-related quality of life, and self-efficacy~     for asthma management. Data will be collected before participants are assigned to AIM2ACT or~     the self-guided control, post-treatment, and 4 month follow-up time points.~   "
96656|NCT02302027|"~     Chronic headache is most often associated with drug abuse and medication overuse headache~     (MOH) is the main complication of migraine disease results in chronic daily headache. The~     first phase of treatment consists of drug withdrawal .~      The second phase of treatment (called consolidation) is to maintain the balance: treating~     headaches and reducing / stopping the drug use.~      The aim of this study is~        1. verify the feasibility of a home withdrawal treatment with normobaric oxygen therapy~          (NOT) delivery by high flow concentrator~        2. use normobaric oxygen therapy (NOT) as a therapeutic measure to treat headache through~          withdrawal period.~      It is a feasibility pilot study in chronic headache with or without medication-overuse. All~     patients receive a care for outpatient withdrawal that involves sudden stop drug abuse and~     used to be called traditional management. The subsequent attacks will be treated with NOT~     from a high-flow concentrator~      Primary endpoint. Feasibility study of treatment with NOT evaluated by the percentage of~     patients who accepted NOT during the withdrawal phase then to treat attacks.~      Secondary endpoints. Efficacy will be assessed by the percentage of patients having no~     chronic headaches two months after the start of withdrawal (less than 15 days of headache per~     month) and no longer in drug abuse (less than 10 days per month with drug intake).~      Visits V1 (first visit) Inclusion V2 at one month V3 at 3 months V4 (last vist) at 6 months~      Effective : 30 patients~   "
96657|NCT02302014|"~     Patients admitted as an unscheduled hospital admission with either a acute heart failure~     syndrome (ACF) or acute coronary syndrome (ACS) will be eligible if their 6-12 month~     mortality risk is estimated to be 20% or greater at the time of discharge. Mortality risk is~     estimated using GRACE (for ACS) or EFFECT (for AHF) scores. Patients are randomly allocated~     to receive a holistic care intervention based around the creation of a detailed Future~     (anticipatory) Care Plan which is agreed with the patient and their family and which is~     shared with the Family Doctor and Emergency Services including ambulance teams. Primary~     endpoint is quality of life assessed by questionnaire.~   "
96658|NCT02302001|"~     ERBEjet Breast augmentation is a novel method of dissection of the subpectoral pocket. Study~     is designed to differentiate parameters of pain between randomized laterality using no touch~     technique. THIS IS NOT A FREE STUDY. Patients are required to pay the initial cost of surgery~     but will receive a refund of a partial payment. Patients must undergo evaluation at~     consultation and surgical quote is provided.~   "
96659|NCT02301988|"~     This is a randomized, double-blind, placebo-controlled, multicenter, pre-operative Phase II~     study designed to estimate the efficacy of ipatasertib combined with paclitaxel chemotherapy~     versus placebo combined with paclitaxel chemotherapy in women with Stage Ia - IIIa~     triple-negative breast adenocarcinoma. The anticipated time on study treatment is 12 weeks.~   "
96660|NCT02301975|"~     This study is a randomized, double-blind, double-dummy, parallel group, multicenter,~     non-inferiority study. The study will enroll adult and adolescent asthmatic subjects who are~     currently receiving mid dose inhaled corticosteroids (ICS) plus long-acting beta2-agonist~     (LABA) (equivalent to fluticasone propionate [FP]/salmeterol 250/50 microgram [mcg]twice~     daily [BD]), either via a fixed dose combination product or through separate inhalers. The~     study consists of a LABA washout period of 5 days and a run-in period of 4 weeks, followed by~     a treatment period of 24 weeks, and a follow up contact period of one week. The total~     duration of the study is 30 weeks. Approximately 1461 subjects will be randomized to one of~     the following three treatments (487 per treatment): fluticasone furoate (FF)/vilanterol (VI)~     100/25 mcg once daily (OD) in the evening (PM) via ELLIPTA™ inhaler plus placebo BD via~     ACCUHALER™/DISKUS™; FP/salmeterol 250/50 mcg BD via ACCUHALER/DISKUS inhaler plus placebo OD~     (PM) via ELLIPTA inhaler; FP 250 mcg BD via ACCUHALER/DISKUS inhaler plus placebo OD (PM) via~     ELLIPTA inhaler. In addition, all subjects will be supplied with albuterol/salbutamol~     inhalation aerosol to use as needed to treat acute asthma symptoms. This study will determine~     if FF/VI 100/25 mcg OD via ELLIPTA inhaler is non-inferior to FP/salmeterol 250/50 mcg BD via~     ACCUHALER/DISKUS inhaler in adult and adolescent asthmatic subjects already adequately~     controlled on a twice-daily ICS/LABA.~      SERETIDE, ELLIPTA, ACCUHALER, RELVAR, and DISKUS are trademarks of the GlaxoSmithKline Group~     of Companies.~   "
96661|NCT02301962|"~     This is an open label, multicenter, non-comparative, phase IV study of panitumumab~     monotherapy in Indian subjects with previously treated, wild-type Kirsten rat sarcoma viral~     oncogene homolog (KRAS) and wild-type Neuroblastoma rat sarcoma viral (v-ras) oncogene~     homolog (NRAS), metastatic colorectal cancer. This study is designed to fulfil the~     requirement of the Indian regulatory authority to characterize the safety and tolerability of~     panitumumab when administered to Indian subjects with wild-type KRAS and wild-type NRAS~     metastatic colorectal cancer. Approximately 58 Indian subjects with previously treated~     wild-type KRAS and wild-type NRAS, metastatic colorectal cancer will be enrolled in order to~     achieve the target enrollment of 50 evaluable subjects who have received at least one dose of~     panitumumab. Subjects will receive panitumumab 6 milligram/kilogram (mg/kg) intravenously~     every 14 days until disease progression, intolerability, withdrawal of consent, or death. All~     subjects will be followed at 4 weeks and 8 weeks after the last administration of~     panitumumab, unless the treatment was discontinued due to withdrawal of consent or death of~     the subject.~   "
96662|NCT02301949|"~     Background: Repeated episodes of bleeding from gastrointestinal vascular malformations~     refractory to endoscopic or surgical therapy often pose a major therapeutic challenge.~      Methods: The investigators will perform a randomized, double blind, placebo controlled study~     of thalidomide as a retreatment therapy for recurrent gastrointestinal bleeding due to~     vascular malformation. Patients with failure of first course treatment of thalidomide will be~     randomly grouped, prescribed a second four-month course regimen of 25 mg of thalidomide or~     placebo orally four times daily. All patients will be monitored for at least one year. The~     primary end point is defined as the patients whose rebleeds decrease from baseline by ≥ 50%~     at 12 months and the cessation of bleeding. Rebleeding is defined based on a positive fecal~     occult blood test (FOBT) (monoclonal colloidal gold color technology) at any visit after~     treatment. Secondary outcomes include the participants dependent on blood transfusions and~     changes from baseline in transfused packed red cell units, bleeding episodes, and hemoglobin~     levels at 12 months. Statistical significance is defined at P < 0.05.~   "
96663|NCT02301936|"~     The primary objectives of this study are to evaluate the antiviral efficacy, safety, and~     tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for~     12 or 24 weeks in adults with genotype 1 or 4 hepatitis C virus (HCV) infection with sickle~     cell disease (SCD).~   "
96667|NCT02301884|"~     The investigators performed open-labeled pilot study which evaluates the efficacy and safety~     of allergen-specific intralymphatic immunotherapy (ILIT) for allergens including~     Dermatophagoides farinae (Df), Dermatophagoides pteronyssinus (Dp), cat, and dog that are~     sensitized and provoke rhinitis-related symptoms in patients with allergic rhinitis.~   "
96668|NCT02301871|"~     A long term habitual posture with abnormal loading of ligaments and muscles, leads to~     development of neck pain. 33 patients including 18 males and 15 females were selected and~     randomly allocated into three groups using sealed opaque envelope containing treatment~     allocation. Group A (n=11) received conventional treatment such as MHP (Moist Heat Pack),~     Static Stretching exercises, Cervical spine non-thrust mobilization, Cervical spine active~     ROM (Range of Motion) exercises and Postural exercises. Group B (n=11) received DNF training~     with conventional treatment. Group C (n=11) received Muscle Energy Technique (MET) in~     additional to conventional treatment. Primary outcome measure functional disabilities and~     secondary measure pain and ROM were recorded at baseline, 7th day and 14th day.One-way ANOVA~     was used for within group analysis. Repeated measure ANOVA followed by post hoc analysis was~     employed for between group comparisons. The results suggest that there was a significant~     improvement in mean change scores of Neck Disability Index (NDI), Visual Analogue Scale (VAS)~     and Range of Motion (ROM) .Both DNF training and MET have additional therapeutic effects over~     a standard care by reducing functional disabilities, pain and in improving ROM in mechanical~     neck pain patients.~   "
96669|NCT02301858|"~     The project aims to compare the histopathological and molecular characteristics of tumour~     tissue from metastases with similar analyses of the primary tumour in the lung, where it is~     available.~      The investigators will therefore perform analysis of blood samples if possible, to identify~     predictive markers in blood samples.~   "
96670|NCT02301845|"~     This is an interventional crossover study aimed at validating diatom shells as a marker for~     cuff leak and microaspiration in mechanically ventilated, critically ill patients.~   "
96671|NCT02301832|"~     This is a study intended to evaluate a non-invasive device that uses light to measure the~     amount of oxygen in the muscles of injured and non-injured legs in specific situations. The~     name of this technology is NIRS (near-infrared spectroscopy). The goal of this study is to~     collect the information necessary to understand the use of the NIRS monitoring system to~     diagnose and direct treatment decisions in case of complications sometimes experienced in~     traumatic tibia fracture, such as excessive swelling called acute compartment syndrome (ACS).~   "
96672|NCT02301819|"~     Eligible patients with severe cardiogenic shock will be randomized to one of the two arms:~     immediate ECMO therapy or early conservative therapy. In the invasive group, veno-arterial~     ECMO will be implanted according to the local practice with flow settings to ensure~     sufficient tissue perfusion. With the exception of ECMO implantation in the invasive group,~     all other diagnostic and therapeutic procedures will be done according to the current~     standard of care at the tertiary cardiovascular center, including other cardiovascular~     interventions (i.e. percutaneous coronary intervention or cardiac surgery). Implantation of~     other mechanical support devices including ECMO in the primary conservative group is allowed~     in the case of shock progression with rise of serum lactate by 3 mmol/L in comparison with~     the lowest value during the past 24 hours. Follow-up include visits at 30 days, 6 moths and~     12 months.~   "
96673|NCT02301806|"~     To investigate whether single administration of sitaglitpin can restore acute endothelial~     dysfunction and ameliorate impaired increase of the number of endothelial progenitor cells~     (EPCs) after oral glucose loading in patients with T2DM.~      To compare the effect of sitagliptin and glimepiride on endothelial function evaluated by~     flow-mediated vasodilatation (FMD) and the number of circulating EPCs in patients with T2DM.~   "
96674|NCT02301793|"~     As part of mandatory on-going nursing education, the investigators have incorporated~     identical information into two distinct web-based learning formats - the traditional linear~     PowerPoint format (with voice-over) and a new interactive format developed with central~     nursing education.~      The investigators will cluster randomize nurses by floor to receive either the traditional~     education or the new interactive education, and evaluate the impact on administration of VTE~     prophylaxis doses administered by nurses before and after education. All nurses on a floor~     will receive the same educational format. If one method of education results in statistically~     significant improvement in VTE prophylaxis administration, the investigators will cross over~     to deliver the superior education format to all nurses who originally were given the less~     effective method.~   "
96675|NCT02301780|"~     Phase III two arm double-blinded randomised controlled trial to examine the effect of~     prophylactic low-dose aspirin from the first-trimester of pregnancy in women at increased~     risk for PET on the incidence and severity of the disease~   "
96676|NCT02301767|"~     The purpose of the study is to view what normal breast tissue looks like on an MRI and~     mammogram to help determine how it may affect the risk of developing breast cancer. The~     investigators will also compare the information collected from the questionnaire and medical~     records to help better understand how this may affect the risk of developing breast cancer.~     If a saliva or tissue sample is collected for future use, this information will enable us to~     study genetic risk factors as well.~   "
96677|NCT02301754|"~     INVAC-1 is intended to be used for the treatment of adult patients with advanced solid tumors~     unresponsive to currently available therapies, or for whom no standard therapy is available.~   "
96678|NCT02301741|"~     A fundamental clinical problem in individuals with chronic low back pain is the significant~     alteration in movement patterns that restrict lumbar spine motion. This is particularly true~     for individuals with fear of re-injury with movement (i.e., kinesiophobia). The primary aims~     of the current study are to use a whole body video game environment to 1) determine the~     effects of game play on lumbar spine flexion and expectations of pain and harm and 2)~     determine the effects of altered movement gain on lumbar spine flexion.~   "
96679|NCT02301728|"~     The purpose of this study is to determine whether the acetate, butyrate and propionate~     concentration in breast milk and to evaluate the possible correlation of these concentrations~     with maternal diet.~   "
96680|NCT02301715|"~     The purpose of this study is to determine the effect of intranasal administration of OT on~     behavior and discourse of insecure adolescents during a disagreement (stressful situation)~     with parents.~   "
96681|NCT02301702|"~     Maternal immunization with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis~     vaccine (Tdap) is a potential strategy to protect young infants against pertussis before they~     are fully vaccinated because maternal antibodies may cross the placenta and passively protect~     her infant. The proposed study is a randomized, blinded, controlled, vaccine trial of~     maternal Tdap vaccination during the third trimester of pregnancy (Tdap vaccination at 27-36~     weeks gestation). Pregnant women will be recruited from the prenatal care clinics at the~     Hospital Nacional Occidente and the Health Centers in Quetzaltenango, La Esperanza, San Juan~     Ostuncalco and Concepción Chiquirichapa. Enrolled women and their infants will be followed up~     until 7 months post-partum.~   "
96682|NCT02301689|"~     The SchlaHF XT Registry is a longitudinal study of patients with heart failure (HF). The~     study aims to understand the importance of diagnosis and treatment of sleep disordered~     breathing (SDB) on HF with the following questions:~      How often does SDB occur in HF? What forms of SDB occur and how are they treated? How does~     SDB develop over time? How does the heart failure therapy affect SDB? What is the treatment~     adherence of patients treated? Does SBD and its treatment affect the survival of heart~     failure patients?~   "
96683|NCT02301676|"~     The purposes of this study are to determine whether long-term postoperative cognitive~     dysfunction (POCD) is occured after general anesthesia and anesthetic drugs have an effect on~     the result about POCD.~   "
96684|NCT02301663|"~     Microvascular coronary dysfunction (MCD) (abnormities in small blood vessels/arteries in~     heart) with symptoms of persistent chest pain, primarily impacts women. There are an~     estimated 2-3 million women in the US with MCD and about 100,000 new cases annually. Recent~     data from our research group suggests that coronary microvascular disease impairs the way the~     heart relaxes. This pilot study will attempt to exacerbate this phenotype in an effort to~     better understand the pathophysiology of the disease. The investigators will recruit 30~     volunteers total (10 healthy calibration subjects, 10 women with microvascular disease, and~     10 age-match women for the group with microvascular disease). Subjects will undergo a series~     of stress maneuvers in conjunction with advanced cardiac magnetic resonance imaging.~   "
96685|NCT02301650|"~     Mother to child transmission(MTCT) is the main route of hepatitis B virus(HBV)~     transmission.High HBV DNA level of pregnant women is the main risk factor of MTCT. Many~     literatures demonstrate that using nucleoside (acid) analogs in late pregnancy can~     significantly reduce HBV DNA level and effectively blocking MTCT. Therefore, treatment~     guidelines of hepatitis B in Europe and the Asia Pacific region clearly pointed out:~     Nucleoside (acid) analogs can be used in pregnant women after 28 weeks of gestation for~     blocking MTCT in mothers with high HBV DNA level. At present, the drugs used in late~     pregnancy including lamivudine (LAM) ,telbivudine(LdT) and tenofovir(TDF).~      The safety of nucleoside (acid) analogues used in late pregnancy on children is not clear.In~     most of the related researches,the observation termination was 7-12 months after birth, and~     most were concentrated on the blocking effect of MTCT.The long-term impact of Nucleoside~     (acid) analogues on children's development has not been reported in the literatures. The aim~     of this study is to make clear of the effect of nucleoside (acid) analogues used in late~     pregnancy on long-term impact of children's development.~      The one year old children born in Beijing Ditan hospital and whose mothers had taken LAM,LdT~     or TDF during late pregnancy will be enrolled as study group, and eligible children whose~     mothers untreated will be enrolled as control group. The children's height, weight,~     nutritional status, developmental quotient and immune response to hepatitis B vaccine etc~     will be evaluated at baseline and at 3 years old. By comparing the children's development in~     different groups as well as in self-control of different ages, we will discuss the effect of~     Nucleoside (acid) analogues on children's long-term development.~   "
96686|NCT02301637|"~     The purpose of this clinical trial is to collect imaging data on embryos followed to~     blastocyst stage (Day 5-6) for ongoing development and validation of the Eeva System.~   "
96687|NCT02301624|"~     To evaluate the safety and efficacy of eculizumab in the treatment of refractory gMG as an~     extension trial for the subjects who have participated in the ECU-MG-301 trial.~   "
96688|NCT02301611|"~     The majority of melanoma vaccines tested to date have been antigen-specific vaccines~     targeting melanoma-specific or associated antigens and utilizing a variety of delivery~     systems and immune-adjuvants. As opposed to testing an off the shelf vaccine that might be~     able to treat a subset of patients, our approach has been personalized to the patient and~     applicable to all patients. Our vaccine approach consists of harnessing the most potent~     antigen presenting cell in the body - the dendritic cell (DC) - together with the full~     repertoire of tumor antigens from an individual's cancer. We have conducted phase I and II~     studies using an autologous DC-tumor cell fusion technique that has now been simplified into~     a DC-tumor cell lysate vaccine. The autologous tumor lysate (TL) is loaded into yeast cell~     wall particles (YCWP) that are naturally and efficiently taken up into the patient's DC.~     These autologous tumor lysate, particle-loaded, DC (TLPLDC) are injected intradermally (ID)~     monthly x 3 followed by boosters at 6, 12, and 18 months.~   "
96689|NCT02301598|"~     The purpose of the study is evaluating safety and clinical efficiency of full femtosecond~     laser-assisted anterior lamellar keratoplasty (FS-ALK) for curing patients with keratoconus~     and corneal opacities~   "
96690|NCT02301585|"~     A randomized controlled clinical trial to evaluate whether a passive leg raising test to~     guide fluid therapy of patients with septic shock can reduce fluid balance and weight gain.~     Patients will be treated according to an algorithm in which the indexed stroke volume (stroke~     volume related to body surface area) and mean arterial pressure will guide the timing and~     amount of fluid and the use of inotropic and vasoactive support. Patients will be randomized~     to either an intervention group in which a passive leg raising test will be made prior to any~     decision for fluid administration or to a control group where this test is not performed and~     fluid administration is carried out according to standard of care at the department.~      Hypothesis: A passive leg raising test, will reduce weight gain by day 3 by 30%.~   "
96691|NCT02301572|"~     Chart review.~   "
96747|NCT02300831|"~     The recent development of therapies targeting specific biomarkers mutations is changing the~     standards of care and prognosis of patients with advanced NSCLC, but very few data are~     currently available on those emerging biomarkers. In addition, the correlation of biomarkers~     with patients' clinical outcomes in a standard of care setting is poorly understood. This~     study aims to address that need.~   "
96692|NCT02301559|"~     Primary dysmenorrhea is the result of hypercontractility and uterine vascular ischemia is the~     most common gynecologic complaints in young women. According to the intensity of symptoms may~     impair daily living, work and leisure activities. Pilates brings the concept of moving the~     body for the recovery, maintenance and promotion of health through exercises that stimulate~     circulation, improving physical conditioning, flexibility and proper postural alignment, and~     promote improvement in the levels of body awareness, coordination and muscle control. In this~     sense, the objective is to investigate the effects of pilates in the symptomatology of~     primary dysmenorrhea. This is a study to be developed with students of Physical Therapy from~     the State University of Piauí-UESPI presenting with primary dysmenorrhea compatible clinical~     picture. A questionnaire will be used for research. The students with the framework of~     dysmenorrhea that meet the inclusion criteria will be assessed for anthropometric parameters,~     pain, flexibility, indirect assessment of contraction of transversus abdominis and quality of~     life before and after the treatment protocol using the pilates method, often 3 weekly~     meetings, totaling 20 sessions.~   "
96693|NCT02301546|"~     The current study will test the effectiveness of a computerized cognitive (thinking) training~     program on improving thinking and memory in patients with mild cognitive impairment. The~     investigators will also examine how short term changes in thinking abilities (i.e., practice~     effects) can be related to improvement in thinking abilities after the cognitive training~     program.~   "
96694|NCT02301533|"~     Antiretroviral therapy (ART) can improve health, prevent complications due to HIV infection,~     and prevent HIV transmission by making people less infectious. Men who have sex with men~     (MSM) are at high risk for transmitting HIV, but face stigma and discrimination that can make~     ART adherence difficult. Our goal is to find out if an intervention involving provider~     counselling and support from an MSM peer will improve ART adherence and engagement in care~     among Kenyan MSM. This study will be carried out in the KEMRI clinic in Mtwapa with 70 MSM~     patient participants who reside in this area, identified through our outreach and testing~     programs in Mtwapa. Six providers and five peers who are trained for the intervention will~     also be consented in order to collect data on their feedback and help monitor the study. Our~     intervention consists of support from a trained peer with experience taking ART and enhanced~     counselling from providers that is aimed to motivate patients to improve and maintain their~     health. In an initial pilot test, we will implement our intervention with 10 MSM starting ART~     for the first time. After any needed revisions to research procedures and training, we will~     next conduct a small randomized controlled trial with 60 MSM patient participants to~     determine feasibility, acceptability, tolerability, and safety, and estimate an initial~     effect size for the adherence intervention. The 60 patient participants will be randomized to~     our intervention or to standard counselling care, and will be followed for 6 months to~     evaluate their ART adherence and retention in care. Providers and peers will give feedback at~     regular project meetings and in in-depth interviews after the pilot test and after the RCT.~     The work proposed for this project will be carried out over 2 years, from June 1, 2014~     through May 31, 2016.~   "
96695|NCT02301520|"~     Vitamin D deficiency is common worldwide, including in infants and children, and rickets~     remains a public health concern in many developing countries. The vitamin D status and~     prevalence of vitamin D deficiency in the Haitian population has not been studied. There is~     currently no approved point-of-care testing device for vitamin D deficiency. Iodine~     deficiency and resulting hypothyroidism is the leading cause of preventable~     neuro-developmental delay and cognitive impairment worldwide. Young infants and children are~     especially susceptible to sequelae of disruption in thyroid function given the dependence of~     the developing brain on sufficient levels of thyroid hormone. Perchlorate and thiocyanate~     have been described as potential environmental disrupters of thyroid function. Lead~     intoxication is a significant cause of disease throughout the world. Millions of people have~     suffered the effects of lead poisoning. Although most developed countries have taken drastic~     measures to limit the environmental lead levels, many countries in the developing world have~     not been able to address, or even assess, the problem.~      Our objectives are to study the following three components in 300 Haitian children between 9~     months and 6 years of age in three different geographical areas of Haiti: 1) Vitamin D status~     and prevalence of rickets, environmental factors associated with low vitamin D levels, and~     the accuracy and efficacy of a vitamin D point-of-care testing (POCT) device for the~     screening of vitamin D insufficiency. 2) Iodine status and thyroid function, and~     environmental disruptors such as perchlorate and thiocyanate as potential risk factors for~     abnormal thyroid function. 3) Lead levels and the extent of childhood lead poisoning.~   "
96696|NCT02301507|"~     There has been increasing use of technology in delivery of healthcare and increasing use of~     cellular phone and text messaging services to help with various healthcare related issues~     including but not limited to medication adherence and clinic attendance. Mobile phones~     technology has been used for healthcare delivery and prevention strategies such as smoking~     cessation. In the present era, cell phones have become part of daily life for most people~     even among those in lower economic groups. There have also been several studies looking at~     cell phone text messaging services to improve adherence to ART among HIV infected subjects~     but no studies have so far been done in HIV infected young women to help retention and~     adherence to care. The overall goal of this study is to evaluation of the impact of texting~     intervention to improve adherence to care and treatment in HIV infected young women.~      Study Hypothesis:~      Text message intervention will improve adherence to ART in HIV infected young women.~   "
96697|NCT02301494|"~     This study is being conducted by Brian Poligone, MD PhD. The purpose of this study is to~     determine safety, effectiveness, and tolerability of two topical therapies, imiquimod and~     fluocinonide, for patients with early stage Cutaneous T-cell Lymphoma (CTCL).~   "
96698|NCT02301481|"~     This prospective, randomized phase II study is designed to evaluate weather neoadjuvant~     chemoradiotherapy is superior to neoadjuvant chemotherapy with both followed by surgery and~     postoperative chemotherapy for locally advanced gastric adenocarcinoma.~   "
96699|NCT02301468|"~     A randomized controlled trial will be conducted to examine the effectiveness of DN versus IC~     on trigger points in the neck and shoulder region for reducing pain and improving~     functionality (primary outcome measures) and to investigate the effectiveness of DN versus IC~     for muscle strength, mobility and muscle tone (secondary outcome measures).~   "
96700|NCT02301455|"~     One of the most powerful predictors of stroke is hypertension, with estimates of~     approximately 33% of adults in the United States experiencing this condition.~      Hypertension is very prevalent in the emergency department (ED), but significantly~     undertreated. The overall goal of this project is to develop a text messaging intervention to~     improve hypertension care in the ED. This will first be done by testing the feasibility of~     identifying hypertensive patients in the ED, and the response rate to text messages.~   "
96701|NCT02301442|"~     Exercise has consistently yielded short-term, positive effects on health outcomes in people~     with multiple sclerosis (MS). However, these effects have not been maintained in the~     long-term. Behaviour change interventions aim to promote long-term positive lifestyle change.~     This study, namely, Step it Up will compare the effectiveness of an exercise plus Social~     Cognitive Theory (SCT)-based behaviour change intervention with an exercise plus control~     education intervention on walking mobility among people with MS.~   "
96702|NCT02301429|"~     The purpose of this study is to evaluate the implant procedure and feasibility of a new lead~     developed to pace and sense the left chambers of the heart.~   "
96703|NCT02301416|"~     This study tests the efficacy of the medication, Qsymia, as an adjunct therapy in superobese~     individuals planning to undergo weight loss surgery. Individuals taking the medication before~     and after surgery will be compared to historical controls who had surgery without taking the~     medication.~   "
96704|NCT02301403|"~     This study is a 2-arm randomized clinical trial (RCT). Participants motivated to quit smoking~     will be randomized to one of two treatments: 1) a Modern Usual Care (M-UC) vs. 2)~     Abstinence-Optimized Cessation Treatment (AOCT). The components for the optimized treatment~     have strong theoretical and empirical support from the investigators previous screening~     studies.~   "
96705|NCT02301390|"~     This study to is being conducted in India to determine the role of catheter-based ablation~     for ventricular tachycardia (VT) in post- heart attack patients who meet established~     guidelines for implantable cardiodefibrillator (ICD) implantation, but cannot afford it.~     These patients would be started on chronic Amiodarone therapy, which has been shown to be~     effective but can often lead to multiple side effects.~      Patients will therefore be randomized in an even proportion to either a) the control group,~     receiving chronic Amiodarone therapy, or the study group, undergoing catheter ablation of VT~     in addition to chronic Amiodarone therapy.~      This trial will serve as a representative model for the developing world.~   "
96706|NCT02301377|"~     The investigators know that adherence to medications in children with cystic fibrosis (CF) is~     poor. Forgetfulness has often been reported as a barrier to adherence by both CF patients and~     their parents. Many of the investigators patients also report being motivated by the results~     of their lung function studies (PFTs) to stay adherent to their medications. In this study,~     the investigators would like to see if providing medication reminders and allowing patients~     to measure their lung function at home will lead to better adherence. This will be a pilot~     study to determine the feasibility of providing such as a device to children with CF.~   "
96707|NCT02301364|"~     The purpose of this study is to find out what effects, good and/or bad, Buparlisib (also~     known as BKM120) has on lymphoma and the central nervous system.~   "
96708|NCT02301351|"~     The purpose of this study is to examine the effect of changes in cigarette package color and~     warning label features on smoking behaviors and beliefs about cigarette risks.~   "
96709|NCT02301338|"~     The purpose of this study is to assess the impact of more frequent follow-up (by~     videoconference) of these patients. Videoconference is a method of communication over a~     distance. In this method, the patient will hear the person's voice (like on the telephone)~     and will see that person over video.~      The study will compare more frequent follow-up of patients by videoconferencing to routine~     follow-up of patients. The investigators will compare each type of follow-up to see the~     effect on the number of times patients need to visit emergency rooms or need admission to~     hospitals. The study will also look at the difference between each type of follow-up on~     patients' quality of life and social support thirty days after hospital discharge.~      The study will also measure satisfaction and acceptability of this intervention among those~     who had follow-ups by videoconference.~   "
96710|NCT02301325|"~     Project 1, Study 2 will evaluate the impact of very low nicotine content cigarettes with and~     without transdermal nicotine on cigarettes smoked per day, nicotine exposure,~     discomfort/dysfunction, other health-related behaviors, nicotine/tobacco dependence,~     biomarkers of tobacco exposure, intention to quit, compensatory smoking, other tobacco use,~     cigarette characteristics, cue reactivity, cardiovascular function, perceived risk and cue~     reactivity. The investigators will also consider differences between conditions in compliance~     with product use and the ability to abstain from smoking when provided a financial incentive~     for abstinence.~   "
96711|NCT02301312|"~     This study evaluates the safety and performance of a new vascular graft made of POSS-PCU as a~     vascular access conduit for haemodialysis. 30 patients requiring access for dialysis will be~     enrolled and monitored at regular intervals for 18 months.~   "
96712|NCT02301299|"~     The investigators plan to develop and adapt a community-partnered intervention using~     community health promoters (Stroke Promoters) to deliver messaging regarding stroke symptom~     awareness and the need for calling 911 after stroke onset. The study investigators will~     implement this intervention in 2 large south side Chicago communities and measure the impact~     on symptom onset to hospital arrival times and EMS utilization using an interrupted~     time-series analysis.~   "
96713|NCT02301286|"~     The purpose of this study is to determine whether acetylsalicylic acidis effective on the~     recurrence and survival of colon cancer patients.~   "
96748|NCT02300818|"~     Glaucoma is among the leading causes for blindness in the western world. Elevated intraocular~     pressure (IOP) has been identified as the most important risk factor. However, some patients~     progress despite adequate IOP lowering while some subjects with elevated IOP never develop~     glaucoma. Other patients develop glaucoma although IOP measurements were always in the normal~     range. Therefore, other factors must be involved. In the last years, studies using MRI have~     been performed and evidence has accumulated that also changes in retrobulbar structures are~     present, in particular in the lateral geniculate nucleus and the visual cortex. However,~     these studies were limited by the low spatial resolution of the MRI instruments used.~   "
96714|NCT02301273|"~     Patients who have been admitted to Intensive Care Units (ICU) and are intubated and~     mechanically ventilated for longer than 48 hours have impaired physical, psychological and~     social health and well-being six to twelve months after discharge. The advocacy of intensive~     physiotherapy and mobilization early in the course of critical illness has been established.~     It is of great importance to study the long-term outcomes (physical function and quality of~     life) in intubated and ventilated patients who start exercising and ambulating mobilizing) as~     soon as possible during ICU stay because the most effective mode, intensity or frequency of~     exercise needs to be identified.~      The aim is to study the short- and long-term outcomes of enhanced early physiotherapy and~     upright position in critically ill patients on prolonged invasive ventilation and to develop~     principles to guide physiotherapists in their clinical decision making in the ICU.~   "
96715|NCT02301260|"~     The purpose of this research study is to investigate the effectiveness of a computerized~     technique designed to improve processing speed (i.e. the amount of time it takes for a~     person's brain to process information) in a multiple sclerosis (MS) population. The study is~     designed to study how well this technique can help people with MS increase their processing~     speed and their ability to function better in everyday life. This treatment protocol has been~     studied extensively with older adults, showing improvements on standard laboratory measures~     of processing speed and performance of activities of daily living.~   "
96716|NCT02301247|"~     This study is a double-blind placebo-controlled randomized clinical trial (RCT) to provide~     Class I evidence in support of or in refute of the efficacy of the modified Story Memory~     Technique (mSMT) in persons with progressive MS, with outcome measured through three~     mechanisms: (1) a traditional neuropsychological evaluation (NPE) (2) an assessment of global~     functioning (AGF) examining the impact of the treatment on daily activities, and (3) an~     optional functional magnetic resonance imaging (fMRI) scan.~   "
96717|NCT02301234|"~     The purpose of this study is to demonstrate the efficacy, safety, and tolerability of~     fulranumab as adjunctive therapy compared with placebo in participants with signs and~     symptoms of osteoarthritis of the hip or knee that are not adequately controlled by current~     pain therapy.~   "
96718|NCT02301221|"~     The purpose of this study is to evaluate the effect of fecal microbiota transplantation in~     adults with slow transit constipation.~   "
96719|NCT02301208|"~     This is a randomized Phase III study to evaluate efficancy of weekly cisplatin or nedaplatin~     concurrent with Intensity-modulated radiation therapy in Nasopharyngeal Carcinoma (NPC).~   "
96720|NCT02301195|"~     This study is being carried out to learn more about the effects of Therapeutic Horseback~     Riding (THR) for children and adolescents with an autism spectrum disorder (ASD). This~     treatment is very popular and horseback riding for children and adults with disabilities has~     been used as a form of therapy in the United States for over forty years. However, very~     little research has been done to find out whether or not THR is effective as a therapy for~     children with an ASD. This study is being done to see if THR will improve the agitation~     behaviors, coordination, and communication skills of children and adolescents with an ASD.~     This study is also being done to find out if the horse is necessary for children and~     adolescents with an ASD to improve.~   "
96721|NCT02301182|"~     A Single-Center Randomized, Patient-Blinded, Prospective Five-Year Study to Compare the~     Functional Results after Insertion of ADM X3-MoP Cup (Stryker) and a CoC Cup (Zimmer) in~     Primary THA. 60 patients will be enrolled during a 2 year period. At surgery tantalum beads~     will be inserted into predrilled holes of the polyethylene rim for assessment of motion of~     the large mobile poly in the ADM Trident Cup by use of RSA. Patients will be followed by~     functional examinations as well as PROM assessment.~   "
96722|NCT02301169|"~     The purpose of this clinical trial conducted in patients suffering from chronic pain is to~     study the relationship between individual patients' profile and their analgesic response.~   "
96723|NCT02301156|"~     This study evaluates the addition of ublituximab, a novel monoclonal antibody, to ibrutinib~     compared to ibrutinib alone in previously treated Chronic Lymphocytic Leukemia (CLL) patients~     with high-risk cytogenetic features. Half of the participants will receive ublituximab in~     combination with ibrutinib, while the other half will receive ibrutinib alone.~   "
96724|NCT02301143|"~     This clinical study is in subjects who are 18 years old or older with locally advanced~     pancreatic cancer who have not received prior treatment for their pancreatic cancer. The~     study treats all subjects with nab-Paclitaxel plus gemcitabine for approximately 6 months of~     treatment. Subjects who complete the treatment will choose, with their treating physicians,~     what additional treatment should be given: more nab-Paclitaxel plus gemcitabine,~     Chemoradiation therapy, or surgery to treat the locally advanced pancreatic cancer.~   "
96725|NCT02301130|"~     Mogamulizumab in Combination with MEDI4736 (Durvalumab) and Mogamulizumab in Combination with~     Tremelimumab in Subjects with Advanced Solid Tumors~   "
96726|NCT02301117|"~     Study to evaluate the safety, tolerability, and pharmacokinetics of TAS-102 in patients with~     advanced solid tumors and varying degrees of renal impairment.~   "
96727|NCT02301104|"~     Study to evaluate the safety, tolerability, and pharmacokinetics of TAS-102 in patients with~     advanced solid tumors and varying degrees of hepatic impairment.~   "
96728|NCT02301091|"~     The purpose of this study is to determine whether combined radiofrequency ablation and~     transcatheter chemoembolization (TACE) result in better survival outcomes than TACE alone in~     patients with HCC and portal vein tumor thrombus.~   "
96729|NCT02301078|"~     This study will evaluate short-term pain and function associated with percutaneous needle~     aponeurotomy (PNA) and injections of the enzyme collagenase clostridium histolyticum in~     patients with Dupuytren's disease. Scores on outcome measures will be compared between groups~     to determine whether treatments differ in terms of hand function and pain during the early~     post-treatment period.~   "
96749|NCT02300805|"~     Endometrial volume will be assessed by 3DUS and VOCAL and compared to the results of office~     hysterscopy to measure the abilty of this technique to diagnose endometrial polyps in women~     complaining of abnormal uterine bleeding.~      The safety of both procedures will be compared .~   "
96841|NCT02299609|"~     Successfully perfused STEMI patients will receive routine transthoracic echocardiography qid~     for 4 days or placebo. Myocardial function and infarct size will be evaluated at 3 and 6~     months.~   "
96730|NCT02301065|"~     Viral infections and reactivation during pediatric allogeneic hematopoietic stem cell~     transplantation (HSCT) are a common occurrence and significantly contribute to~     post-transplant morbidity and mortality. The risk is high due to prolonged periods of immune~     deficiency while awaiting immune reconstitution post-transplant. Current strategies to reduce~     complications from viral infections include prophylactic treatment, close monitoring for~     viral infections and prompt treatment at the first sign of symptoms or increasing viral load.~     However, the most definitive treatment for viral infections remains the host's cellular~     defenses. Improved understanding of the immune systems response to viral infections may lead~     to better treatment strategies.~      This study is being done to explore the relationships between T-cells and NK cells (infection~     fighting cells) and viral infections or reactivations in young allogeneic stem cell~     transplant patients. The investigators will be looking at how these cells react and function~     in young patients receiving allogeneic stem cell transplantation, as well as in healthy stem~     cell donors.~   "
96731|NCT02301052|"~     Purpose of study is evaluation of Allium ampeloprasum Spp.Iranicum cream efficacy in~     management of symptomatic hemorrhoids in a double blind randomized placebo-control trial~   "
96732|NCT02301039|"~     The purpose of this study is to determine the efficacy of pembrolizumab in patients with~     advanced sarcomas.~   "
96733|NCT02301026|"~     The purpose of the study is to monitor initiated Diafer® therapy administered according to~     hospital practice and the product labeling in routine clinical practice in haemodialysis~     patients with Chronic Kidney Disease.~   "
96734|NCT02301013|"~     Main objective is to evaluate the relation between the increased urethral mobility and~     unsuccessful treatment after TVT and TOT operations.~      140 patients will be included in the research who are planned to have TVT and TOT operations~     with SUI and MUI diagnoses.Female patients of 25 to 70 years of age who are positive for~     stress test will be included.~      All patients will be questioned for parity, body mass index, menopausal state, medical~     history, and examined for POP-Q stage, urodynamy, stress test, UDI 6, IIQ7 and with~     transperineal sonography preoperatively. Passive mobility angle and active mobility angle~     will be measured.~      The relationship between passive mobility angle or active mobility angle and success of sling~     operations will be determined in this study.~   "
96735|NCT02301000|"~     This is a randomized controlled trial to compare the effect of a 10-day course of per oral~     metronidazole versus a one-time rectal instillation of an anaerobically cultivated human~     intestinal microbiota for the treatment of a first occurrence of Clostridium difficile~     infection (CDI). Recurrent CDI is common after standard antibiotic treatment. We hypothesize~     that the instillation of a healthy intestinal microbiota will be more effective in inducing a~     durable cure than metronidazole for primary CDI.~   "
96736|NCT02300987|"~     To assess the efficacy of LEE011 compared to placebo in patients with relapsed/refractory~     teratoma with recent progression~   "
96737|NCT02300961|"~     This pilot study will primarily be evaluated by feasibility and adherence to an iPad-based~     neurocognitive intervention program. It will secondarily be evaluated by performance on the~     neurocognitive testing post-transplant and change in performance in subsequent years.~   "
96738|NCT02300948|"~     There are three objectives in this study:~        1. To assess the serum folate pharmacokinetics of ingesting a single dose of~          PregVit-Folic5® versus a single dose of PregVit® (a multivitamin containing 1.1 mg folic~          acid)~        2. To assess the steady-state red blood cell (RBC) and serum folate concentrations achieved~          in non-pregnant, fertile women who supplement daily with PregVit-Folic5® versus PregVit®~        3. To assess the steady-state RBC and serum folate concentrations achieved before and~          during pregnancy in women planning a pregnancy or early in pregnancy (<6 weeks~          gestation) who supplement daily with PregVit-Folic5® versus PregVit®.~   "
96739|NCT02300935|"~     This study will investigate the combination of two drugs, trametinib and nab-paclitaxel, in~     patients with advanced unresectable or metastatic melanoma. Each drug has shown activity in~     trials of patients with melanoma. However, the combination of these two drugs has not been~     studied. In this trial the investigators will determine the maximum dose of the drug~     combination to be administered to patients with advanced unresectable or metastatic melanoma~     and examine the safety profile of the drug combination.~   "
96740|NCT02300922|"~     Phase I/II, Open-labeled, Prospective, Multi-center study of a Pretargeted Radioimmunotherapy~     in metastatic colorectal cancer with ractionated injections of TF2 plus 90Y-IMP288~     (RITCOLON).~   "
96741|NCT02300909|"~     Prospective evaluation of the safety and efficacy of dHACM on clinical outcomes in lumbar~     laminectomy and microdiscectomy patients as assessed by Oswestry Disability Index.~   "
96742|NCT02300896|"~     The current model of care for the hospitalized elderly patients has been conditioned by many~     factors unrelated to the disease process that caused the hospitalization and usually worsen~     the outcome of hospitalization circumstances. Many times hospitalized elderly patients spend~     most of the time in bed (even higher than 83% of bed rest versus 4% of those who stand or are~     walking). These patients have their functional and physiological reserve reduced which makes~     them more vulnerable to the effects of being bedridden. The consequences are at multiple~     levels emphasizing the functional loss or cognitive impairment, longer stays, mortality and~     institutionalization, delirium, deconditioning, pressure ulcers and decreased caloric intake,~     social isolation, poor quality of life and increased use of resources related to health.~     Exercise training can prevent functional and cognitive decline and modify even the posterior~     trajectory.~   "
96743|NCT02300883|"~     This is an observational prospective analysis of biological characteristics of malignant~     mesothelioma (MM) patients. Frozen and paraffin-embedded tumor specimens and pleural effusion~     of patients will be collected and than will be analyzed with the following analyses:~      1Purification of Tumour Associated Macrophages (TAM) and tumour cells from pleural effusions.~      2.Mass spectrometry analysis of TAMs and tumor cells 3.Co focal microscopy analysis of~     macrophages, tumour cells and specimens derived from patients.~   "
96744|NCT02300870|"~     The primary objective of this proposal is to show the efficacy of contrast enhanced~     ultrasonography in detecting heart transplant rejection in humans. The secondary objective is~     to demonstrate the efficacy of this technique in generating data which allow for the~     assessment of short and long term outcomes.~   "
96745|NCT02300857|"~     This study will evaluate the effect of macronutrient diets on brain activity in homeostatic~     and mesolimbic reward regions.~   "
96750|NCT02300792|"~     This study is a randomized, placebo controlled, double-blinded clinical trial, which included~     50 children with hepatitis A. They were of both sexes and their age ranged from 2 to 18~     years. The patients were randomly assigned into one of two groups; each consisted of 25~     children. Each patient in the intervention group (group 1) took oral honey in a dose of 5~     ml/kg/day (with a maximum dose of 150 ml/day) for four weeks, whereas patients of the placebo~     group (group 2) took placebo in the form of molasses. The main outcome measure was the~     recovery time defined as the number of days from the start of the intervention to subsidence~     of symptoms and signs of hepatitis and return of liver transaminases to their normal levels.~   "
96751|NCT02300779|"~     This trial will compare the efficacy of to 2 different sets of dietary recommendations to be~     followed before colon cleansing for colonoscopy in diabetic patients.~   "
96752|NCT02300766|"~     The purpose of this study is to determine why up to 25% of the pediatric patients who have~     surgery for a tumor in the posterior fossa develops the Cerebellar Mutism Syndrome (CMS).~     Furthermore the purpose is to explore the clinical course and the best treatment of the~     syndrome.~   "
96753|NCT02300753|"~     Expanded access Protocol to treat LHON subjects with EPI743~   "
96754|NCT02300740|"~     Nicotinamide riboside is a newly discovered vitamin B3. The pharmacokinetics in humans is so~     far not analyzed.~   "
96755|NCT02300727|"~     Oral mucositis is a common side effect from cancer treatment. Patients receiving chemotherapy~     and radiotherapy can get very painful sores in their mouth that compromise nutrition and oral~     hygiene as well as increase risk for infection, and can last for weeks. Currently, the only~     treatment for mucositis is oral hygiene to try to support recovery.~      Curcumin (also known as Turmeric) is a frequently-used spice in India and Southeast Asia.~     Studies in cells and animals have shown that it can reduce the amount of bacteria and can~     prevent inflammation.~      In this study, the investigators want to learn if a mouthwash made with curcumin is safe for~     people to use and if it can help their mucositis.~   "
96756|NCT02300714|"~     A comparison of anterioposterior versus oblique view approach method for~     fluoroscopically-guided epidural block in the midthoracic region. The investigators evaluate~     differences on total radiation time and technical feasibility between anterioposterior and~     oblique view approach method.~   "
96757|NCT02300701|"~     To evaluate the efficacy of anti-IgE (Omalizumab/Xolair) in children with severe eczema.~   "
96758|NCT02300688|"~     After administration of besifovir preparations different from each other to healthy subjects,~     the investigators evaluate equivalence of bioavailability of LB80331.~   "
96759|NCT02300675|"~     The purpose of this study is to evaluate the feasibility and the effectiveness of a patient~     education program on patients' adherence to adjuvant hormone therapy (anti-estrogen or~     aromatase inhibitors) for breast cancer, in collaboration with teams of sociologists, patient~     education and medical oncologists.~   "
96760|NCT02300662|"~     A single blind randomized controlled trial (the MoVe ICU study) will be conducted to evaluate~     the effects on critical patients on invasive mechanical ventilation of early mobilization~     with a cycle ergometer.~   "
96761|NCT02300649|"~     Dexmedetomidine is a selective alpha-2 adrenergic agonist that can be considered as an~     adjuvant to propofol or inhalational anesthetics. Dexmedetomidine mediate its cardiovascular~     effect through activation of receptors in central and peripheral nervous system. The classic~     cardiovascular response of dexmedetomidine is the biphasic with initial short-term increase~     in blood pressure followed by long-lasting decrease in BP and HR. There were several reports~     about these hemodynamic changes of dexmedetomidine, but not the evaluation of direct effects~     on cardiac function. The purpose of this study is to evaluate the effects of dexmedetomidine~     as an anesthetic adjuvant on cardiac function by using the transesophageal echocardiography.~   "
96762|NCT02300636|"~     This study investigates different resistive co-contraction trainings effect on knee strength~     recovery after ACL reconstruction. Participants will be divided into three groups. Group 1~     will receive standard ACL rehabilitation with 8 week co-contraction training in open kinetic~     chain position, Group 2 will receive standard ACL rehabilitation with 8 week co-contraction~     training in open kinetic chain position and Group 3 (control group) will only receive~     standard ACL rehabilitation.~   "
96763|NCT02300623|"~     Interventions during primary HIV infection (PHI) can modify the immune control and the~     clinical evolution during the chronic phase. Although several studies suggest the benefit of~     antiretroviral treatment (ART) during PHI, indication of ART is still not universally~     recommended. The investigators randomized patients with PHI, with a favourable immunological~     profile and well controlled on ART, to undergone structured treatment interruptions alone or~     with low doses of IL-2, stopping ART thereafter. The endpoints were immune control of HIV~     replication and time to resume ART. Immunological profile, specific CD4 and CD8 responses and~     clinical data were analysed for both groups up to 48 weeks, and during a long follow-up, up~     to nine years since final ART stop.~   "
96764|NCT02300610|"~     The main purpose of this study is to find out the dose of enzalutamide that can be safely~     given with gemcitabine and cisplatin in patients with advanced bladder cancer. Researchers~     also want to find out the side effects of these drugs when given together. This study will~     also help in finding out the effect on tumor of the combination of enzalutamide, gemcitabine~     and cisplatin.~   "
96765|NCT02300597|"~     Young people between age 15 and 25 with ADHD and/or autism spectrum disorders are offered~     internet-based support and coaching during eight weeks (chat and e-mail). Data is collected~     before and after the intervention and six months after end of treatment using self-report~     questionnaires pertaining to sense of coherence, self-esteem, quality of life, depressive and~     anxiety symptoms and socioeconomic status. Parents complete an assessment scale for the next~     of kin. After treatment the young people are interviewed regarding the quality of the~     intervention. A comparison group matched for age, gender and neuropsychiatric diagnosis is~     offered treatment as usual and is assessed at the same time points as the intervention group.~     The individuals are not randomized due to difficulties to recruit if the individuals do not~     know group assignment in advance.~   "
96766|NCT02300584|"~     The purpose of this study is to refine and test the web-based delivery of a well-established~     in-person group program that provides information and education to informal caregivers~     (family and friends) of persons with Alzheimer's disease (or related illnesses).~   "
96768|NCT02300558|"~     The primary objective of this study is to evaluate the effect of oral eleclazine on mean~     daytime QTcF interval after 24 weeks of treatment with elecalzine in participants with long~     QT syndrome Type 3. During the single-blind treatment period (24 weeks), participants will~     receive eleclazine and/or eleclazine placebo. Following the single-blind treatment period,~     participants who have not permanently discontinued study drug will be eligible, at the~     discretion of the investigator, to continue receiving eleclazine during an open-label~     extension (OLE) phase.~   "
96769|NCT02300545|"~     Pazopanib is FDA approved as a second line and beyond treatment for metastatic soft tissue~     sarcoma. There is a population of elderly and debilitated soft tissue sarcoma patients that~     are not fit for standard first line chemotherapy that is doxorubicin based. As pazopanib is~     well tolerated with minimal side effects, the investigators propose a phase II study to~     evaluate pazopanib as a first-line agent in patients with non-resectable or metastatic~     disease who are not candidates for cytotoxic chemotherapy.~   "
96770|NCT02300532|"~     Post-marketing surveillance to investigate the clinical safety and effectiveness in patients~     of all implantation of Gliadel with malignant glioma in the actual medical setting.~   "
96771|NCT02300519|"~     Personalized therapy in haemophilia has not been reached yet. Treatment is substitutive and~     its doses are only based on the levels of deficient factor VIII (for haemophilia A) or IX~     (for haemophilia B). The bleeding severity is not only related to the factor deficiency but~     also to levels of other coagulation factors (e.g. factor X, II, AT or TFPI). It's necessary~     to take them into account in order to individualize treatments; and Thrombin Generation Assay~     (TGA) with the CAT method (Calibrated Automated Thrombography) is a good way because it~     measures the result of the coagulation cascade. TGA on Platelet Rich Plasma (PRP) is even~     closer to physiological conditions than on Platelet Poor Plasma (PPP) because platelet~     influence is represented. It has already been shown (at least in PPP) that the bleeding~     tendency in haemophilic patients is usually well correlated to TG. Some TG parameters are~     used to characterize the individual coagulation phenotype, the most important being the~     Endogenous Thrombin Potential (ETP) and the Lag Time (LT). A hemorrhagic profile usually~     provides a longer lag time and / or a lower ETP. However, only few studies tried to determine~     the influence of each coagulation factor and inhibitor on TG. They were done on Platelet Poor~     Plasma (PPP) or on lyophilized plasma. So the relation between coagulation factors and the~     different TG parameters remains to be determined, especially in the haemophilic case. It is~     possible, experimentally, to find the optimal dose of the factor to be added by measuring TG~     in samples with different factor VIII or IX concentrations, but this method would be time~     consuming and expensive, especially because it should be done for each haemophilic patient. A~     better way consists in using TG numerical models. For a set of initial factor levels they~     simulate the TG and its associated parameters. It is now essential to validate the existing~     models, especially in haemophilic cases, in order to see whether they are reliable and can be~     used in clinical practice afterwards.The objective of this study is to validate thrombin~     generation numerical models which could predict the factor VIII or IX activity correction to~     reach a thrombin generation sufficient to avoid bleeding. A comparison between the TG~     observed in haemophilic patients and the TG predicted by the models is needed to validate the~     models. In order to define a 'safe' TG i.e. sufficient to avoid bleeding, normal ranges of TG~     parameters have to be measured.~   "
96772|NCT02300506|"~     The objective of this study is to determine the survival status of patients enrolled in study~     GLI01S (all-case observational study).~   "
96773|NCT02300493|"~     Examining the effect of daily self-weighing on the ability of student to prevent from gaining~     weight during their four years at Cornell.~   "
96774|NCT02300480|"~     Chronic pain after laparoscopic cholecystectomy (LC) is a common complication with an~     incidence ranging between 3-56%. In many cases, however, the cause chronic pain after LC~     remains unknown and visceral hyperalgesia and central sensitization have been suggested to be~     part of the pathophysiology. So the purpose of this study is to determine whether Calot's~     Triangle Block (CTB) combined with patient controlled intravenous analgesia (PCIA) is~     superior to PCIA in reducing the incidence of chronic pain after LC.~   "
96775|NCT02300467|"~     The purpose of this open-label, dose-escalation phase I trial is to evaluate the safety,~     tolerability and pharmacokinetic profiles and to assess the efficacy of NOV120401 (CKD-516~     Tablet), a novel vascular disrupting agent, in patients with advanced refractory solid~     tumors.~   "
96776|NCT02300454|"~     Use of SeQuent® Please drug coated balloon (DCB) is effective to treat patients with in-stent~     restenosis (ISR). However, whether the type of pre-dilatation balloon prior to DCB dilatation~     impacts on clinical and angiographic outcomes or not is unknown. Lacrosse® Non-slip element~     balloon (NSE) is a balloon catheter with 3 longitudinal plastic elements which are attached~     to proximal and distal balloon edges. NSE is developed to incise neointimal tissue and avoid~     balloon slippage without vitiating balloon derivability and crossability. We investigated~     angiographic and clinical outcomes following normal non-compliant balloon or NSE dilatation~     prior to DCB dilatation in ISR lesions.This study is a single blinded, multicenter,~     randomized trial. Total 200 patients with ISR are randomly assigned to treat with~     non-compliant balloon or NSE before DCB dilatation. Optical coherence tomographic (OCT)~     analysis are performed before pre-dilatation and after DCB dilatation Follow-up angiography~     analysis are planned at 8 months in all patients. Clinical follow-up is planned at 8 and 24~     months.Primary endpoint is angiographic in-segment late loss at 8 months.~   "
96777|NCT02300441|"~     A prospective cohort pilot study of non-cardiac patients to determine the feasibility of~     recruiting 150 patients to undergo postoperative continuous hemodynamic monitoring for up to~     3 days.~   "
96778|NCT02300428|"~     Iron deficiency anaemia (IDA) affects approximately 4.7 million of people in the UK, with~     children and pre-menopausal women being at higher risk (1). Each year more than 6.8 million~     prescriptions for oral iron are filled in England alone (NHS Information Centre data).~     However, gastrointestinal symptoms limit adherence in 10-30% of otherwise healthy patients~     (2-4) and in up to 50% of patients with gastrointestinal disorders (5). Simple ferrous iron~     salts constitute the vast majority of currently prescribed oral iron because these are cheap~     and well absorbed. However, they are also poorly tolerated and thus, we believe, are~     expensive to the NHS.~      Funded by the Medical Research Council, we have developed an alternative oral iron~     supplement, that we name IHAT (iron hydroxide adipate tartrate), as an efficacious therapy~     for IDA with minimal side-effects.~      In the study proposed here we aim to assess the total health cost associated with current~     oral iron supplements and, hence, define the clinical unmet need for alternative treatments.~     We will use Clinical Practice Research Datalink (CPRD) GOLD data to (i) estimate the pattern~     of prescribing to oral iron in primary care in the general population and (ii) develop a~     health economics model in pre-menopausal women. These data will provide evidence for the~     total health system costs associated with current oral iron treatment. Furthermore, this~     study will provide data from which the cost-effectiveness and total health system costs of~     alternative effective and treatments with minimal side-effects could be estimated.~   "
96842|NCT02299596|"~     This study will compare the outcome after surgery between a group of patients that receives~     instructions for prehabilitation training and one group that received standard treatment.~   "
96779|NCT02300415|"~     Severe sepsis and sepsis shock are common in emergency department, with a high mortality~     rate. The potential severity of this disease impose a diagnosis as early as possible to start~     antibiotic therapy and hemodynamic support. Conventional biomarkers are an important support~     for the emergency physician. However, comparison of sensitivity and specificity for new~     biomarkers, like presepsine, suggests that they can be more efficient in this area.~      In this single-center, prospective, non-interventional study, we propose to compare the~     sensitivity of presepsine to that of lactate for the diagnosis of severe sepsis and septic~     shock We emit to main hypothesis that the sensitivity of presepsine is higher than that of~     lactate for the diagnosis of severe sepsis.~   "
96780|NCT02300402|"~     The present study aims to further optimize a whole-body Diffusion‐Weighted Magnetic Resonance~     Imagery (DW-MRI or DWI) protocol on 3 Tesla MR and/or new system combining 3Tesla MR and~     Positron Emission Tomography (PET), to develop and validate an automated whole-body~     parametric image analysis algorithm, and to determine the added value of whole-body DWI to~     Fluorodeoxyglucose-PET for the management of lymphoma patients.~   "
96781|NCT02300389|"~     The main purpose of study is to compare the effectiveness of Hypofractionated IMRT boost~     Radiotherapy to Conventional IMRT boost Radiotherapy for high-risk prostate cancer patients~     combined with Androgen Deprivation Therapy.~   "
96782|NCT02300376|"~     Diagnosis of patients with renal insufficiency and recommendations for medical treatment of~     patients who suffer from chronic renal failure are based on the different stages of~     Glomerular Filtration Rate (GFR). Many formulas exist to assess GFR. However these formulas~     are unreliable in many clinical situations (old people, obese patients…). Methods for~     measuring GFR using exogenous tracers exist: Inulin and 51Cr-EDTA are historical reference~     tracers. Renal clearance of Inulin is the gold standard. However, using these methods is~     restricted to specialized services because it is long and expensive.~      There is no medical data for the use of Calcium edetate de sodium as a tracer to assess GFR.~     Calcium edetate de sodium is a treatment for lead intoxication. The extension of use as a~     tracer comes from its exclusive elimination by glomerular filtration.~      Plasma and renal clearance of Calcium edetate de sodium and Inulin will be measured for every~     included patient during a hospital day care (First visit V1). For transplanted patients,~     plasma clearance of Calcium edetate de sodium will be repeated within one week (more or less~     48hours) during annual medical check-up of renal transplantation (Second visit V2).~   "
96783|NCT02300363|"~     This study will be conducted as a single-center, open-label, 2-period, single-sequence,~     drug-drug interaction study to assess the effects of multiple-dose LX4211 400 mg (2 × 200-mg~     tablets qd × 7 days) on the PK of single-dose rosuvastatin (1 × 10-mg tablet) in healthy male~     and female subjects.~   "
96784|NCT02300350|"~     This study will be conducted as a single-center, open-label, 2-period, single-sequence,~     drug-drug interaction study to assess the effects of multiple dose LX4211 (400 mg~     administered as 2 × 200-mg tablets qd × 12 days) on the PK of single-dose digoxin (2 ×~     0.25-mg tablets) in healthy male and female subjects.~   "
96785|NCT02300337|"~     Optimization the cuff pressure of the laryngeal tube (LT) in relation of the mechanical~     ventilation, and the reduction of potential leakage mucosal trauma. Comparison of the~     tightness of LT between the filling volume specified by the manufacturer (connectors are~     color coded syringe and blocker), 60cmH₂O, 50cmH₂O, 40cmH₂Ound 30cmH₂O. The measurement of~     the leakage occurs in ml / kg body weight.~   "
96786|NCT02300324|"~     There is current evidence that suggests eating cruciferous vegetables like broccoli,~     cauliflower, cabbage is beneficial to our health as they contain compounds which are thought~     to reduce the risk of diseases such as cancer and cardiovascular diseases. Cruciferous~     vegetables are able to deliver in our body a group of compounds called isothiocyanates (ITCs)~     that are thought to be responsible of their health-promoting effects. Sulforaphane (SF) from~     broccoli is one of the most studied ITCs and its anticancer properties have been extensively~     investigated in in vitro and in vivo models.~      The investigators propose to undertake an intervention study to measure the bioavailability~     of SF from the soups used in another intervention study called ESCAPE. The investigators~     would like to investigate the rate and extent to which SF reaches the systemic circulation~     and is excreted in urine by measuring SF and its metabolites in plasma and urine samples~     collected from apparently healthy participants after consumption of the three types of~     broccoli + stilton soups. The three types of soups are standard broccoli + stilton soups and~     two high-glucoraphanin (SF precursor) broccoli + stilton soups which are able to deliver~     different levels of SF.~      This study has been funded by Biotechnology and Biological Sciences Research Council (BBSRC)~     and Prostate Cancer foundation (PCF).~   "
96787|NCT02300311|"~     To evaluate efficacy of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide) versus placebo in~     patients with acute low back pain. To investigate the safety and tolerability of repeated use~     of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide).~   "
96788|NCT02300298|"~     To determine the appropriateness of the dose of nintedanib 200 mg b.i.d. plus docetaxel 75~     mg/m2 as starting dose by evaluating the safety in Japanese patients with body surface area~     (BSA) <1.5 m2 and locally advanced or metastatic adenocarcinoma subtype non-small cell lung~     cancer (NSCLC) after failure of first line platinum- based chemotherapy~   "
96789|NCT02300285|"~     Our aim is to determine the feasibility of using continuous glucose monitors (CGMs) in~     infants with low blood glucose to improve how we care for these infants. To do this we plan~     on monitoring blood glucose levels with CGMs (instead of only with intermittent~     bloodsampling) in late-preterm and term infants admitted to the NICU who have had~     hypoglycemia. To see if using CGMs helps us prevent low blood glucose levels and allows us to~     find a diagnosis and treat sooner, we will randomize patients into one of two groups: a CGM~     group where the CGM information is made available to the NICU team and a Standard of Care~     group where the CGM information will only be available to the research team. However, if~     infants in the Standard of Care group are noted to have three unrecognized severe low blood~     glucose levels then the research team will inform the NICU team that this has occurred.~   "
96790|NCT02300272|"~     This is a single-center, observational study design. Enrolled participants will be typically,~     healthy older adults. Participants will complete daily computerized measures, in addition to~     continuously wearing an Actiwatch device. The study period will last 2 weeks. The objectives~     of the study are to examine the impact of sleep, pain, and circadian rhythm on~     practice-related learning in older adults at their preferred versus nonpreferred times of~     day.~   "
96791|NCT02300259|"~     The first purpose of this study is to evaluate the effect of itraconazole (and possibly~     diltiazem) on the amount of LY2623091 in the blood stream and how long the body takes to get~     rid of it.~      The second purpose of the study is to evaluate the effect of LY2623091 on the amount of~     simvastatin (and possibly tadalafil) in the blood stream and how long the body takes to get~     rid of it.~      The safety and tolerability of LY2623091 when given with itraconazole, simvastatin and~     diltiazem or tadalafil will be evaluated.~      There will be three groups of participants in this study. Results from Groups 1 and 2 will be~     analyzed during the study to determine whether to enroll participants in Group 3 or 4. The~     study is expected to last up to 40 days from the first dose to follow-up (inclusive).~     Screening may occur up to 28 days prior to enrollment.~   "
96792|NCT02300246|"~     The platelet-rich fibrin (PRF), belongs to a new generation of plasma concentrate with~     biomechanical processing simplified and without the need for handling blood biochemistry.~     Some studies have shown the potential of PRF in release growth factors assisting and~     accelerating the regeneration of soft tissues, however with contradictory results regarding~     the hard tissues. The aim of this study will be to evaluate through clinical analyzes,~     histomorphometric and micro-computed tomographic images, the dimensional changes, the~     quantity and the quality of the tissues formed socket after extractions that receive~     membranes of PRF. 15 sockets (test group) will receive a membrane of PRF after extraction and~     the other 15 (control group) received no biomaterial (spontaneous healing).~   "
96793|NCT02300233|"~     The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 26~     weeks in patients with Hypertriglyceridemia~   "
96794|NCT02300220|"~     This study investigates the effects of targeted re-treatment of patients who do not recover~     from an exacerbation of COPD. Half of the patients will receive ciprofloxacin while the other~     half will receive a placebo.~   "
96795|NCT02300207|"~     To investigate the changes of cardiovascular function during short-term simulated~     weightlessness after electroacupuncture (EA) treatment．~   "
96796|NCT02300194|"~     Introduction:~      Opioids, such as morphine, act at receptors in the central nervous system, but many studies~     have suggested direct action peripherally on opioid receptors in sensory neurons terminals,~     melanocytes, keratinocytes and fibroblasts. These receptors are stimulated when occurs~     inflammatory processes.~      Hypothesis:~      Treatment with topical morphine 0.1% applied 30 minutes before an invasive procedure,~     decreases pain in children.~      Method:~      A randomised double-blind parallel study to evaluate the effect of topical application of a~     0.1% morphine gel in patients undergo a procedure. 22 patients in each group will be~     included. Randomly assigned to either the morphine gel or a placebo hydrogel, it will be~     applied 30 minutes before the procedure and the first day every 4 hours. General basic~     sedation and systemic analgesia will give for all the patients. Efficacy of treatment will be~     measured with Face, Legs, Activity, Cry, Consolability scale (FLACC scale).~   "
96797|NCT02300181|"~     The purpose of the present study is to evaluate the effect of the extract of the flour~     fermented with Bacillus subtilis var natto DC-15 on postprandial glucose level in subjects~     with prediabetes.~   "
96798|NCT02300168|"~     The aim of the current observational study is to better assess the relationships between~     neuromuscular blockade and multiple surgical outcomes in patients undergoing elective~     laparoscopic bariatric surgery.~   "
96799|NCT02300155|"~     The purpose of this study is to compare the tolerability of Pregvit® to a common prenatal~     vitamin (Orifer® F) among pregnant women with morning sickness or those suffering from a~     variety of conditions.~   "
96800|NCT02300142|"~     This is a voluntary study to allow subjects who received placebo while on GEN-003-002 to be~     randomized, in a blinded manner, to 1 of 6 active combinations of GEN-003 and Matrix-M2.~      Objectives:~        -  To compare the impact on clinical Herpes Simplex Virus type-2 (HSV-2) disease among 6~          different combinations of GEN-003 antigens and Matrix-M2 adjuvant measured by:~             -  Time to first clinical and/or virologic recurrence after Dose 3 (Day 43)~             -  Proportion of subjects who are recurrence free at 6 and 12 months after the last~               dose of vaccine~             -  Lesion rate (percent of days with genital lesions present) during the~               post-vaccination follow-up period~             -  Antiviral use.~        -  To evaluate the safety and tolerability of GEN-003 in combination with Matrix-M2.~   "
96801|NCT02300129|"~     Phase 2a study to assess the efficacy and safety of CD07805/47 0.5% gel in the prevention of~     the flush of rosacea.~   "
96802|NCT02300116|"~     The study is used to verify the accuracy and repeatability of Smart Vision Labs Refractor.~   "
96803|NCT02300103|"~     The primary objective of this study is to evaluate the efficacy, safety and tolerability of~     treatment with sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) with ribavirin (RBV) for 24 weeks~     in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead~     sponsored study and did not achieve sustained virologic response (SVR).~   "
96804|NCT02300090|"~     A real world study to determine the effectiveness of a patient support service to aid COPD~     patients in their self management.~   "
96805|NCT02300077|"~     The μ-opioid receptor agonist methadone is frequently used in adult anesthesia and adult pain~     therapy. Methadone has an extremely long half-life, which confers therapeutic advantage by~     providing more stable plasma concentrations and long-lasting pain relief. Methadone~     perioperative pharmacokinetics and effectiveness in perioperative pain relief in inpatients~     is well characterized. There is, however, no information on methadone use in an ambulatory~     surgery setting and outpatient procedures. This pilot investigation will determine~     effectiveness of intraoperative methadone in reducing postoperative opioid consumption and~     providing improved pain relief in patients undergoing moderately painful, ambulatory surgical~     procedures.~   "
96806|NCT02300064|"~     The purpose of this study is to find out more about the effects of chronic obstructive~     pulmonary disease (COPD) on the function of blood vessels, the heart, and muscle at rest and~     during exercise.~   "
96807|NCT02300051|"~     The purpose of this study is compare three interventions (short-term psychodynamic~     psychotherapeutic group and relapse prevention group therapy vs. treatment as usual, namely,~     psychiatric follow up including prescription of medication vs. both interventions combined)~     to individuals presenting compulsive sexual behavior.~   "
96808|NCT02300038|"~     Background Subanesthetics concentrations of lidocaine are able to produce a differential~     block of the ectopic discharges, but not propagation of impulses, suppressing differentially~     the associated neuropathic pain symptoms. The aim of this study was to investigate the~     differences between the analgesic effects of lidocaine 0.5% and a control group of lidocaine~     0.1% on several neuroma related pain modalities.~      Methods Sixteen patients with neuropathic pain due to painful neuromas caused by nerve injury~     participated in this randomized, double-blind experiment. The patterns of sensory changes~     were compared before and after injection of 1 ml lidocaine 0.5% and 0.1% close to the~     neuroma, the sessions being 1-2 weeks apart. Spontaneous and evoked pains were assessed using~     a visual analogue scale (VAS), quantitative and qualitative sensory testing.~   "
96809|NCT02300025|"~     This study is an open-label, multi-center, single-dose, parallel group study to determine the~     pharmacokinetics, safety, and tolerability of cobimetinib administered at 10 mg to fasted~     male and female adult subjects with varying degrees of hepatic function. The study will be~     conducted based on the Child-Pugh classification of hepatic impairment. The anticipated~     duration of the study is 7.5 weeks. The target sample sizes are: 18 volunteers with varying~     degrees of hepatic function and up to 12 healthy control volunteers.~   "
96810|NCT02300012|"~     Incident rates of ACL rupture are greatest in 16-39 year olds at almost 1 in 1,000.~      Performance Based Investigations (PBIs) can be used to evaluate and select correct approaches~     to patient treatment, and biochemical, biomechanical and physiological biomarkers in other~     conditions are sensitive in distinguishing between disease state severities, type of injuries~     and responsiveness to treatment. Despite the measurement sensitivity of PBIs, these are not~     widely used possibly owing to their focus postoperatively where benefits are less worthwhile.~      This study aims to investigate novel biomarkers as performance based investigations (PBIs) to~     improve surgical and treatment strategies in anterior cruciate ligament (ACL) patients. The~     objectives are to identify whether biomarkers, collected before and after operations, can: 1)~     Assist the surgeon in decision making; 2) Lead to improved prognosis; 3) Be used to predict~     the outcomes of prognosis, and; 4) Correlate with disease signs/ smoking to help further~     understand ACL injuries.~   "
96811|NCT02299999|"~     Open label multicentric phase II randomized trial, using high throughput genome analysis as a~     therapeutic decision tool, which aims at comparing a targeted treatment administered~     according to the identified molecular anomalies of the tumor with maintenance chemotherapy~     (targeted substudy 1) as well as immunotherapy with maintenance chemotherapy in patients~     without actionable genomic alterations or non eligible to substudy 1 (immune substudy 2).~   "
96812|NCT02299986|"~     'Ventilator-Induced Diaphragmatic Dysfunction (VIDD) was originally described by~     Vassilakopoulos and Petrof in 1998, where it is used to cover the effects of mechanical~     ventilation and respiratory muscle unloading on the diaphragm. A recent article by Grosu and~     colleagues has demonstrated that the thickness of the diaphragm decreases with about 6% a day~     in a small cohort of mechanically ventilated patients. This is a longitudinal, single-centre,~     observational cohort study to examine the long-term effects of invasive mechanical~     ventilation on the diaphragm, and to study the risk factors associated with VIDD.~   "
96813|NCT02299973|"~     Intestinal microbiota dysbiosis is thought to play an important role in the complex~     pathophysiology of irritable bowel syndrome (IBS), especially in diarrhoea-predominant IBS~     and possibly in IBS with severe bloating. Fecal microbiota transplantation or FMT has been~     shown to be an effective means of correcting this imbalance in the gut microbiota, especially~     in patients with recurrent Clostridium difficile infections where it has become a preferred~     treatment strategy.~      In a preliminary pilot study in 12 patients we found that FMT was a safe and accepted therapy~     in IBS patients. In 75% of patients an amelioration of IBS symptoms in general and abdominal~     bloating was seen three months after transplantation.~      In this study the effects of FMT on patients with IBS without constipation and bloating will~     be investigated in a double blind, placebo controlled RCT.~   "
96814|NCT02299960|"~     The main purpose of this study is to analyse test-retest-reliability of functional~     quantification of endothelial dysfunction through puls-amplitude-tonometry in patients with~     heart failure with preserved/reduced ejection fraction, pulmonary hypertension, arterial~     hypertension and diabetic nephropathy. In the same group, test-retest-reliability of~     circulating endothelial cells as well as test-retest reliability of non invasive cardiac~     output Monitoring will be observed and analysed.~   "
96815|NCT02299947|"~     The purpose of this study is to answer the following question: Leads a primary coagulation~     corrected with a single dose of fibrinogen concentrate after ascending aorta-arc~     reconstruction to a decrease in the number of allogenic blood transfusions, compared to~     placebo?~   "
96816|NCT02299934|"~     This study plans to learn more about the two Magnetic Resonance Angiography (MRA) techniques.~   "
96817|NCT02299921|"~     This study plans to learn more about people who are sick in the hospital with a lung~     infection, or respiratory failure. Respiratory failure, or severe lung failure, is a~     life-threatening disease. When it happens, the lungs have trouble carrying out their normal~     function of getting oxygen into the blood, and removing carbon dioxide from the body.~     Investigators are conducting this study to see what drinking too much alcohol, using tobacco~     products, or using drugs (both legal and illegal) may do to lung infections and respiratory~     failure.~      Subjects are asked to be in this research study because they are thought to have a lung~     infection and may also have respiratory failure. Alcohol, tobacco, and drug use have been~     linked to lung infections, respiratory failure, and even death, but the reasons for this~     aren't known. People who use unhealthy amounts of alcohol, tobacco, and or drugs may be more~     at risk for lung infections, and for severe complications due to lung infection. Subject~     participation is important whether or not you use alcohol and or drugs.~   "
96854|NCT02299440|"~     The primary objective of this study is to assess the efficacy of ketamine versus a placebo~     for the short-term (at 72h, i.e. 24h after the last perfusion) relief of suicidal ideation,~     measured using the BSS hetero questionnaire, in patients hospitalized for suicide risk.~   "
97197|NCT02294968|"~     The aims of this study are to determine whether a group-based parent support program (Family~     Startup) can lead to early improved parental sense of competence, family relations, and~     child development. Evaluation is based on a randomized controlled trial, with half of the~     participants receiving Family Startup and the other half receiving treatment as usual.~   "
96818|NCT02299908|"~     Acute postoperative pain is one of the most important centers of therapeutic attention in~     postoperative phase of any procedure. It is a complex entity that requires a multiple~     intervention to be treated and, depending on the intervened surgical site, it has different~     approaches.~      Despite attempts to reduce postoperative pain by implementing management protocols, rates of~     pain prevalence from moderate acute to severe pain are still reported as high as 50% in the~     first 24 postoperative hours. Among the surgeries that report greater intensity of~     postoperative pain is open inguinal Herniorrhaphy. That is why several techniques have been~     described for the management of acute pain in this surgery postoperative, among which PAT~     blocking has shown to be beneficial in some studies. However, some reports question its~     usefulness but with the emergence of ultrasound-guided techniques for its realization,~     interest in this blockage has grown back.~      This study aims to demonstrate the utility of the PAT blocking in the management of acute~     pain of pre-peritoneal inguinal herniorrhaphy with mesh.~   "
96819|NCT02299895|"~     Background:~      In the field of health promotion, the 'setting approach' has gained increased attention over~     the last decades. Following this approach, organizations and governments are urged to invest~     in health and health promotion. However, the dissatisfaction with the broad definition of the~     term 'setting' has grown. As many health promotion programs are carried out in organizational~     settings, substantial work has been done on how to acknowledge organizational factors in~     designing and implementing health promotion programs. Organizational settings differ from~     others because they can also address their clients as beneficiaries of health promotion~     programs, also known as 'client-oriented health promotion'. Among the most prominent~     organizational settings for health promotion are schools and hospitals, and more recently,~     long-term care (LTC-) facilities. However, dissemination and implementation of~     client-oriented health promotion in organizational settings seem to be very challenging. Most~     approaches dealing with barriers to health promotion implementation in schools, hospitals,~     and LTC-facilities rarely reflect the specific organizational characteristics. This~     negligence constitutes both, a research gap in the setting approach and in the design of~     health promotion practice. Hence, the aim of this study is to explore professionals'~     (teachers', health professionals', care aids') views and attitudes that influence the~     implementation of client-oriented health promotion programs between schools, hospitals, and~     LTC-facilities in Austria.~      Methods:~      With that aim in mind, the investigators chose a comparative qualitative design.~     Semi-structured interviews will be conducted with 90 professionals (30 in schools, 30 in~     hospitals, and 30 in LTC-facilities). In addition, non-participant observations as well as an~     extensive document analysis in each setting will be undertaken. The data will be analyzed by~     thematic analysis. Comparisons within as well as between the organizational settings will be~     conducted using selected categories.~      Discussion:~      To date, this study is the first of its kind that compares results of individual~     semi-structured interviews between different organizational settings. This study investigates~     professionals' views and attitudes on facilitating and hindering factors of implementing~     client-oriented health promotion programs and thus will provide a solid basis for future~     research activities and evaluation studies in the field of health promotion implementation.~   "
96820|NCT02299882|"~     Determine the effect of Vancomycin Powder added to the surgical wound at closure on surgical~     infection rates.~   "
96821|NCT02299869|"~     Comparative Study to Evaluate the Cosmetic Appearance of Two Brands (Coopervision (CVI) vs.~     Competitor)of Color Soft Contact Lenses~   "
96822|NCT02299856|"~     Cardiac magnetic resonance (MR) is an established noninvasive diagnostic tool for detection~     of acute myocarditis. Diagnosis of myocarditis at 1.5T is currently made with the help of the~     Lake Louise Criteria (two of three criteria have to be positive in order to establish the~     diagnosis). Although these criteria are accepted and widely used in clinical routine, several~     disadvantages exist. Newer parameters like myocardial T1 and T2 mapping, extracellular volume~     fraction (ECV) and myocardial strain analysis have the potential to complement or even~     replace some of the Lake Louise Criteria and further enhance the diagnostic performance of~     cardiac MR in patients suspected of having acute myocarditis. The aim of our study is to~     evaluate the diagnostic performance of a comprehensive cardiac MR protocol in patients with~     acute myocarditis.~   "
96823|NCT02299843|"~     Currently，the ALPPS (associating liver partition with portal vein ligation for staged~     hepatectomy) procedure which enables the rapid growth of the future liver remnant and extends~     surgical indication to patients with mid-advanced stage hepatocellular carcinoma becomes a~     research hot spot. However, the procedure has a high morbidity and mortality rate.Using~     radio-frequency ablation instead of in-situ split of liver to avoid forming a coagulation~     band in stage I will reduce the incidence of complications（bile leakage, abdominal~     infection,hemorrhage e.t.) The investigators named this technique as Radio-frequency Assisted~     Liver Partition with Portal vein ligation for staged hepatectomy （RALPPS）.Investigators~     hypothesized that the RALPPS might result in lower morbidity and mortality rate than ALPPS in~     the treatment of hepatocellular carcinoma . This Prospective Randomized Controlled Trial is~     on the Safety and Efficacy of radio-frequency assisted liver partition with portal vein~     ligation for staged hepatectomy for hepatocellular carcinoma.~   "
96824|NCT02299830|"~     The purpose of this study is to evaluate the efficacy and safety of four interventional~     pulmonology techniques for the treatment of malignant central airway stricture.~      The four techniques are：~        -  cryotherapy~        -  argon plasma coagulation~        -  stent~        -  snare~   "
96825|NCT02299817|"~     The main objective is to study the efficacy of denosumab in reducing wear-induced osteolysis~     around uncemented acetabular implants used in total hip arthroplasty. Patients included in~     the study will receive the same dose of 60 mg denosumab or placebo (1 ml solution) for a~     total of 6 doses with start on day one and every 6 months with last treatment at 30 months.~     The primary endpoint will be the change in volume of the osteolytic lesion over 3 years~     measured (measured with 3D-CT in cm³).~   "
96826|NCT02299804|"~     A Multicenter, Double-Blind, Placebo Controlled, Phase Ⅱa clinical trial to enroll 120~     patients with Vertigo Caused By Posterior Circulation Infarction during 7 days, then to~     evaluate the efficacy of different dose of Levophencynonate Hydrochloric, and provide the~     effective dosage for phase IIb clinical study, to study the safety of Levophencynonate~     Hydrochloric.~   "
96827|NCT02299791|"~     The purpose of the ALL Study is to determine the effectiveness of the dissemination of the~     ALL intervention from an integrated care setting into Community Health Centers (CHCs) by~     measuring changes in diabetes mellitus (DM) population prescription rates for the~     medications, using a pre-post comparison within clinics and a staggered, randomized~     implementation across clinics.~   "
96828|NCT02299778|"~     The purpose of this study is to determine whether folate produced by bacteria that live in~     our colon can be absorbed in human colon using a stable isotope method. This study would lead~     a better understanding of the bioavailability of colonic bacterially-synthesized folate and~     its quantitative contribution to whole body folate homeostasis.~   "
96883|NCT02299063|"~     The investigators hypothesize that in addition to a known sympatholytic effect,~     intraoperative dexmedetomidine reduces adverse changes in mitochondrial function and~     structure attenuating ischaemia-reperfusion and end-organ injury for children with non~     cyanotic congenital heart defects having corrective heart surgery.~   "
96829|NCT02299765|"~     Study Title:~      Intercalating and maintenance Gefitinib in combination with chemotherapy (gemcitabine plus~     carboplatin) as first-line treatment for patients with advanced EGFR mutation-positive~     non-small cell lung cancer: A randomized, open-label, multiple-centre study.~      Target population-Treatment naive EGFR mutant-positive advanced NSCLC patients.~      Study Objectives - Primary Study Objective: To investigate whether intercalating and~     maintenance Gefitinib in combination with chemotherapy improve the Progression-Free Survival~     (PFS) vs. Gefitinib alone in advanced NSCLC with EGFR activating mutation.~      - Secondary Study Objective： To evaluate whether intercalating and maintenance Gefitinib in~     combination with chemotherapy improve the Objective Response Rate (ORR), Disease control rate~     (DCR), Overall survival (OS), 2-year OS rate, QOL vs. Gefitinib alone.~      Evaluation the safety of Intercalating and Maintenance Gefitinib in combination with~     chemotherapy.~      - Exploratory objective: PFS of arm A vs. PFS 1 + PFS 2 of arm B Dynamic biomarker analysis~     using blood sample~      a: The PFS 1 of arm B is the time from randomization to disease progression of 1st-line~     therapy or death from any cause, whichever occurs first. The PFS 2 of arm B is the time from~     the time of PFS 1 to disease progression of 2nd-line therapy or death from any cause,~     whichever occurs first.~      Study Design-Prospective, open-label, randomized, multi-center study.~   "
96830|NCT02299752|"~     The aim of the study was to investigate the incidence of glove perforation in cannulation of~     blood vessels (CBV) during resuscitation and compare perforation rates between single and~     double-gloves.~   "
96831|NCT02299739|"~     Herb-induced liver injury is an important issue in musculoskeletal diseases where herbal~     medicine is most frequently used. The low prevalence of drug-induced liver injury (DILI)~     gives rise to the need for large-scale patient studies. We assessed the prevalence of liver~     injury of 6,894 musculoskeletal disease inpatients taking herbal medicine.~   "
96832|NCT02299726|"~     Over one million hospitalizations for acute heart failure (AHF) occur over every year in the~     United States, resulting in high mortality, re-hospitalizations, and incurred financial~     costs; yet nearly every attempt over the last 10 years to improve outcomes with novel~     therapies have all failed. In this proposal, we will study whether a generic drug known as a~     mineralocorticoid receptor antagonist (more commonly known as an aldosterone blocker), proven~     to reduce morbidity and mortality for chronic heart failure patients, is safe and feasible to~     give to AHF patients in the emergency department and during hospitalization for a total of 3~     days. The results of this study will provide necessary and sufficient data to design an~     efficacy study in a larger population to test whether early use of a high-dose of~     mineralocorticoid receptor antagonists will reduce post-discharge morbidity and mortality.~   "
96833|NCT02299713|"~     The purpose of this study is to assess the efficacy of electroacupuncture (EA) on pain~     control, perception of pain, plasma cortisol and beta-endorphins levels, patient-perceived~     quality of life and use of pain medications, in people with chronic knee pain.~   "
96834|NCT02299700|"~     The purpose of this study is to assess the usability of the Janssen Autism Knowledge Engine~     (JAKE) as a system to monitor clinical outcomes in autism spectrum disorder (ASD) (severe~     abnormalities in the development of many basic psychological functions that are not normal~     for any stage in development. These abnormalities are manifested in sustained social~     impairment, speech abnormalities, and peculiar motor movements).~   "
96835|NCT02299687|"~     A clinical trial to investigate the influence of CYP2C19 polymorphism on~     pharmacokinetic/pharmacodynamic characteristics of omeprazole in healthy Korean volunteers~   "
96836|NCT02299674|"~     The purpose of this study is to examine the path and velocity of the center of mass (CoM) and~     center of pressure (CoP) during double support of persons walking with a unilateral~     above-the-knee prosthesis and determine the effects of prosthetic foot stiffness and~     effective length on CoM and CoP.Persons with a lower limb amputation walk with compensatory~     movements that affect the smooth trajectory of the center of mass (CoM) during weight~     transfer. The lack of control in the foot/ankle complex reduces fine motor movements,~     influencing the progression of the CoM and transfer of ground reaction forces represented by~     the center of pressure (CoP). Without control of the ankle joint, prosthetic users fall off~     of their trailing prosthetic limb during weight transfer, resulting in much more abrupt CoM~     and CoP transfers from trailing to leading limb. These abrupt movements during transfer not~     only increase stress on the sound limb, but also decrease the subject's energy efficiency~     during ambulation. The current study will further examine the CoP path and velocity in~     relation to the CoM path and velocity during double support of men with a transfemoral~     prosthesis, as well as explore how prosthetic foot ankle stiffness and effective length~     affects the CoP path and velocity.~   "
96837|NCT02299661|"~     DS-1093a is an inhibitor of hypoxia-inducible factor prolyl hydroxylases, and is expected to~     produce transient dose / exposure dependent increases in erythropoietin levels in subjects~     with chronic kidney disease (CKD). This study will be conducted in 2 parts. Part A will~     involve subjects with stage 3b or 4 CKD, and will be an open, non-controlled parallel group~     investigation of three single doses of DS-1093a (6 subjects/dose), in which allocation to~     dose will be randomised. On completion of this part of the study an optional fourth dose may~     be tested to gain a more complete understanding of the PK/PD behaviour of DS-1093a. Part B~     will be an open, non-controlled investigation of a single dose of DS-1093a in CKD subjects~     (n=6) receiving haemodialysis. The dose for Part B will be determined based on the data from~     Part A.~   "
96838|NCT02299648|"~     This protocol is a screening protocol only. No drug intervention study will be included in~     this protocol. However, based on the molecular profiling, patients may be eligible for~     targeted agents. However, the molecular profiling doesn't guarantee the enrollment onto the~     clinical trial. Currently, the available drugs are AKT inhibitor, MEK inhibitor, Wee1~     inhibitor, MET inhibitor. ATR inhibitor and other agents may be available in the context of~     clinical trials depending on the availability.~   "
96839|NCT02299635|"~     This study is designed to evaluate the preliminary anti-tumor activity and tolerability of~     PF-03084014 when administered as a single agent in the treatment of patients with advanced~     triple receptor-negative breast cancer (mTNBC) harboring genomic alterations in Notch~     receptors (NA+), and in a smaller subset of mTNBC patients whose tumor tests negative for~     genomic alterations in Notch receptors (NA-)~   "
97206|NCT02294851|"~     This is a randomized, double-blind, placebo controlled, single ascending dose escalation,~     safety, tolerability, PK, PD and immunogenicity study of BMS-986168 administered by an~     intravenous infusion in healthy subjects.~   "
96843|NCT02299583|"~     Background: International studies have shown that a substantial number of children and~     adolescents are exposed to potentially traumatic events. Many of these children and~     adolescents, some of whom will experience posttraumatic stress disorder (PTSD), are submitted~     to health care departments shortly after exposure as the most common types of traumatic~     events are accidental injury, serious somatic illness or death of someone close. There has~     been some research on early psychological interventions for prevention and treatment of PTSD.~     However, very little research has examined the efficacy of trauma-informed practice among~     health care professionals (HCPs). The present trial aims to evaluate and compare~     trauma-informed health care with usual practice.~      Methods/Design: The primary clinical question under investigation is the efficacy of an~     early, trauma-informed intervention for the prevention of PTSD in children and adolescents~     following exposure to a potentially traumatic event. The trail compares a standardized~     trauma-informed practice with usual care (no intervention) in health care departments~     receiving children and adolescents after exposure to determine if trauma-informed care is~     associated with a reduction in psychological outcome measures over time. Specifically, the~     investigators examine the efficacy of health care professional's active use of~     trauma-informed standards of action and a trauma training program for HCPs in the~     intervention group. The primary outcome will be a reduction in trauma, anxiety and depressive~     symptoms on self-reports in the active intervention compared to usual care.~      Discussion: This trial will be the first controlled trial to examine a trauma-informed~     intervention carried out by HCPs. It will provide the first evidence on the efficacy of~     health care delivered by trauma-educated HCPs using trauma-informed standards of action. A~     successful implementation of this protocol will support the thesis that prevention of PTSD~     among children and adolescents benefits from a focus on the practice of HCPs. If efficacious,~     the results will be a call for future research to extend the investigation of interventions~     from psychological treatment to HCP-based care.~   "
96844|NCT02299570|"~     This is the first prospective, multi-center, double-blinded, randomized controlled study of a~     microbiota suspension derived from intestinal microbes. Patients who have had at least two~     recurrences of C. difficile infection (CDI) after a primary episode and have completed at~     least two rounds of standard-of-care oral antibiotic therapy or have had at least two~     episodes of severe CDI resulting in hospitalization may be eligible for the study. Patients~     whose CDI returns in less than 8 weeks after the last assigned study treatment may be~     eligible to receive up to 2 treatments with RBX2660 in the open-label portion of the study.~   "
96845|NCT02299557|"~     This is an double blinded, cross-over study to determine the effect of Oxymetazoline gel on~     anal resting pressure and fecal incontinence in patients with spinal cord injury.~     Approximately 17 subjects are expected to complete this 10 weeks study that will include two~     treatment periods of 4 weeks each, and one 2 weeks wash out period.~   "
96846|NCT02299544|"~     BlueWind system safety and performance in treatment of patients diagnosed with overactive~     bladder (OAB)~   "
96847|NCT02299531|"~     This study investigates the effect of varying both energy density and portion size of all~     foods at lunch on preschool children's intake. The foods used in this study are~     commercially-available, commonly-consumed foods with typical variations in energy density.~     The primary aim of the study is to investigate the independent and combined effects of energy~     density and portion size on preschool children's intake at a meal composed of foods typically~     served to this population.~   "
96848|NCT02299518|"~     This phase I trial studies the side effects and best dose of selinexor when given together~     with etoposide with or without mitoxantrone hydrochloride and cytarabine in treating patients~     with acute myeloid leukemia that has returned (relapsed) or has not responded to treatment~     (refractory). Selinexor may help stop the growth of tumor cells by blocking an enzyme needed~     for cancer cell growth. Drugs used in chemotherapy, such as etoposide, mitoxantrone~     hydrochloride, and cytarabine, work in different ways to stop the growth of cancer cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Giving chemotherapy together with selinexor work better in treating relapsed or~     refractory acute myeloid leukemia.~   "
96849|NCT02299505|"~     A Phase I study to assess the systemic exposure, effiacy, and safety of 450 mg ceritinib~     taken with a low-fat meal and 600 mg ceritinib taken with a low-fat meal as compared with~     that of 750 mg ceritinib taken in the fasted state in adult patients with ALK rearranged~     (ALK-positive) metastatic non-small cell lung cancer (NSCLC)~   "
96850|NCT02299492|"~     This proposed study addresses the problem of service disengagement within the mental health~     system. No matter how effective mental health practices are now or become in the future, they~     are of little value should persons with mental illnesses continue to choose not to receive~     them. Consumers have attributed their disengagement from care to having poor alliances with~     care providers, including experiences of not being listened to and not being offered the~     opportunity to make decisions and collaborate in their own treatment. Person-centered care~     planning is a field-tested intervention designed to maximize consumer choice and ownership of~     the treatment process. Providers collaborate with consumers to develop customized plans that~     identify life goals and potential barriers to achieving them. The proposed study tests the~     effectiveness of Person-Centered Care Planning (PCCP) designed to target barriers and~     efficiently implement PCCP throughout an agency. By conducting a randomized controlled trial~     with 14 community mental health clinics from two states, the study will assess whether PCCP~     improves service engagement and consumer outcomes. The study will also utilize qualitative~     methods to understand how care planning impacts service engagement and how implementation~     processes influence organizational and provider level behavior. Designed to bridge the~     science to services gap, this study focuses on two priorities identified by the NIMH~     Diversion of Services and Intervention Research: developing models and methods to implement~     effective mental health services in the community and the study of personalized mental health~     care.~   "
96851|NCT02299479|"~     Increased daytime activity in children and adolescents with type I diabetes is known to be~     associated with overnight hypoglycemia. We therefore wish to perform a prospective clinical~     study to assess the feasibility of using activity monitor data to adjust insulin pump basal~     rates and see whether we can help prevent overnight hypoglycemia following high activity~     days. We plan to carry this out by enrolling 20 subjects (10 subjects 1 to <7 years old and~     10 subjects 7 to 17 years old) with type 1 diabetes managed on insulin pump therapy and~     having them wear activity monitors and CGMs for 3 months. After an initial two-week period to~     establish activity baselines, we will recommend nighttime basal insulin rate adjustments~     based on activity monitor, CGM and insulin pump data.~   "
96852|NCT02299466|"~     The purpose of study is to build a Canadian HTPN Registry to collect pertinent demographic~     and clinical data on the HTPN population in Canada and to determine the factors affecting~     survival, complications and TPN-dependency. These results will help establish standards of~     practice and develop future multi-center studies. This will greatly benefit the HTPN patient~     population.~   "
96853|NCT02299453|"~     This randomized clinical trial is testing if telephone-administered interpersonal~     psychotherapy (IPT) can reduce depression in rural persons living with HIV/AIDS.~   "
96855|NCT02299427|"~     Dog bites result in over 800,000 doctor/ER visits, 6000 hospitalizations, and a dozen deaths~     each year in the United States. By a large margin, children suffer the highest risk - and~     children typically are bitten by familiar dogs in familiar places. Several programs exist to~     reduce pediatric dog bite risk, but few are empirically-supported or theoretically-motivated.~     None are widely disseminated. This study builds from existing child dog bite prevention~     programs to develop and then evaluate a website to teach children safe interactions with~     dogs. The website will be interactive, entertaining, and engaging, allowing children (target~     ages 4-6) to learn in a technologically-sophisticated and interactive environment. It will be~     developed based in behavioral theory. Hearkening child development theory, it will teach and~     permit practice of cognitive skills that develop in early childhood and are critical to~     safety with dogs: impulse control, perspective taking, and attention to details. Hearkening~     health behavior change theory, the website will help children and their parents perceive~     personal vulnerability to bites, recognize normative behavior to protect themselves, and have~     personal motivation to change previous habits. Overarching the website design will be goals~     to create an engaging and entertaining environment, and to facilitate cognitive and~     behavioral change on the part of both child and parent via multiple mechanisms. Besides~     teaching children, the website will educate parents via an innovative messaging system~     triggered by child attainment of points and skill levels.~      Following website development, an evaluation study will investigate usability and efficacy of~     the website using a repeated measures pre-test, post-test experimental design. 68 children~     ages 4-6 will be recruited, complete a pre-intervention assessment evaluating knowledge and~     behavior relevant to dog safety via multiple methods, and then be randomly assigned to use~     either the newly-developed dog safety website or a control pedestrian safety website at home~     over the subsequent 2 weeks. Frequent reminders will encourage website use. Following the~     2-week period, all children will return for a post-intervention assessment battery to~     evaluate knowledge and behavior change. Data will be analyzed using descriptive and~     inferential statistics, with primary hypotheses tested using linear mixed models.~   "
96856|NCT02299414|"~     The purpose of this study is to evaluate whether a blood pressure treatment strategy during~     pregnancy to achieve targets that are recommended for non-pregnant reproductive-age adults~     (<140/90 mmHg) compared ACOG- recommended standard during pregnancy (no treatment unless BP~     is severe) is effective and safe.~   "
96857|NCT02299401|"~     This randomized trial will compare the rates of ongoing pregnancy, safety/side effects and~     acceptability of two medical abortion regimens that are commonly used in Latin America. The~     first regimen will involve three 800 mcg doses of misoprostol taken buccally in three hour~     intervals; the second will involve three 800 mcg doses of misoprostol taken sublingually in~     three hour intervals. This study will also aim to assess the feasibility and acceptability of~     a semi-quantitative pregnancy test (SQPT) for at-home follow-up in both settings.~   "
96858|NCT02299388|"~     The investigators are conducting this research to study the effect of Liraglutide on blood~     pressure. Several studies have shown increased cardiovascular complications and deaths in~     diabetics with hypertension. The importance of blood pressure control in diabetes has been~     shown in many clinical trials. No drug already approved for treating Type 2 Diabetes Mellitus~     is known to reduce blood pressure along with improving diabetes. However, prior research~     studies with liraglutide have suggested that treatment with liraglutide improves blood~     pressure. This effect is seen very quickly and even prior to any weight loss. The mechanism~     behind this effect is yet to be determined.~   "
96859|NCT02299375|"~     This is a randomised, double-blind, parallel-group, multi-centre study evaluating 15~     milligram (mg) twice daily/ Bi-daily (BID) of losmapimod versus placebo, in addition to~     standard of care (SoC).~      The primary objective of this study is to explore the therapeutic potential of losmapimod as~     a treatment to reduce the rate of exacerbations in the subset of participants with~     moderate-to-severe COPD who are at high risk of exacerbation, having experienced two or more~     moderate/severe exacerbations in the preceding 12 months, and who have <=2% of blood~     eosinophils at screening. As secondary objectives safety, effects on lung function, quality~     of life, pharmacokinetic (PK), biomarkers of both disease and inflammation shall be~     evaluated.~      The duration of the treatment period is variable but will be at least 26 weeks and up to a~     maximum of 52 weeks, with the end of study date being established once the final participant~     has been randomized. The purpose of the variable dosing regimen is to enable participants to~     remain in the study for a longer duration, as it is anticipated that this will increase the~     likelihood of observing exacerbation events without increasing the overall study duration. It~     will also enable safety data on dosing periods beyond 6 months to be generated.~      Approximately 200 participants in a 1:1 ratio between losmapimod and placebo will be~     randomized to the study. Sample size re-estimation will be performed during the course of the~     study to potentially increase the sample size up to a maximum of 600 participants.~   "
96860|NCT02299362|"~     The purpose of this study is to examine the treatment, both surgical and non-surgical, of~     patients with any form of early onset scoliosis. Such treatment may include the use of growth~     friendly devices that are surgically or magnetically lengthened; or the use of serial body~     casting or bracing, or observation. Outcomes examined will be what can be seen physically on~     the patient and on x-ray, as well as parent perception of how the treatment effects their~     child with the use of a health-related quality of life (HRQOL) questionnaire.~   "
96861|NCT02299349|"~     Despite a robust multimodal pain management regimen, patients undergoing total knee~     arthroplasty (TKA) continue to report low satisfaction with postoperative pain management.~     Patient satisfaction further declines with any adverse event such as a drug reaction to~     neuroleptic medications or a patient fall due to a femoral nerve block. A new method of pain~     management throughout the hospital experience is warranted to improve patient satisfaction~     and the possibility of related adverse events. The purpose of this study is to examine if~     there is a difference in post operative pain and morphine (MSO4) total consumption for~     hospitalized TKA patients without femoral nerve block receiving an intra-operative~     periarticular injection of bupivacaine liposome suspension versus a concentrated multi drug.~   "
96862|NCT02299336|"~     The Endurance Trial is a phase IV open label clinical study to assess the need for ongoing~     intravitreal aflibercept injections after the 3-year VISTA DME (VGFT-OD-1009) end-point.~     Subjects will be treated with intravitreal aflibercept injections pro re nata (PRN) based on~     the presence of CR-DME (Clinically Relevant-DME). In addition, subjects who meet re-treatment~     criteria will be eligible for focal laser treatment every 90 days.~   "
96863|NCT02299323|"~     The primary objective of this study is to evaluate radiographic outcomes, intra-operative~     parameters, clinical outcomes, and patient satisfaction following circumferential fusion~     using the INDEPENDENCE® integrated plate and spacer with REVOLVE® Stabilization System for~     the treatment of severe low back pain due to lumbar disc degeneration unresponsive to 6~     months of non-operative treatment.~   "
96864|NCT02299310|"~     The purpose of this study is to compare the effect of valsartan and perindopril on HOMA-IR~     Index in patients with chronic kidney disease.~   "
96865|NCT02299297|"~     This is an open-label pilot study of tofacitinib taken daily for 6 months in the treatment of~     moderate to severe AA, and alopecia totalis or universalis, followed by 6 months follow-up~     off drug to assess the incidence and timing of recurrence of disease or documentation of~     delayed response to treatment. There will be the option of increasing the treatment duration~     up to an additional 6 months beyond the initially scheduled 6 months of treatment, if~     clinically indicated, and at the discretion of the investigator.~   "
96866|NCT02299284|"~     A randomized control trial to test the efficacy of a new treatment involving intensive~     home-based bimanual training (Hand-Arm Bimanual Intensive Therapy (HABIT) and intensive~     home-based functional lower-limb training in children with hemiplegia. The protocols have~     been developed at TC Columbia University to be child friendly and draw upon the investigators~     experience since 1998 with intensive movement therapy in children with cerebral palsy. The~     aim is to promote either the use/coordination of movement of the hands or improve lower-limb~     balance, strength, and function. Caregivers will be trained at the investigator center and~     then be asked to do 2 hours per day, 5 days per week, for 9 weeks (90 hours total) of~     activities with their child in their own home. The activities will be supervised by the~     investigators team via computer. Participants do NOT need to live in the New York City area,~     but a one-time weekend visit to the investigators center is required for training. All~     measurement and treatment is performed in the home.~      Participants are randomized to receive either HABIT or lower-limb training. If caregivers~     wish, they may chose to be crossed over at the end of the study and trained to receive the~     other treatment. PARTICIPATION IS FREE. Please check out the investigators website for more~     information: http://www.tc.edu/centers/cit/~   "
96867|NCT02299271|"~     This study evaluates post-operative pain management and narcotic consumption in patients~     receiving a fascia iliaca block with local anesthetic versus patients receiving fascia iliaca~     block with saline for total hip arthroplasty.~   "
96868|NCT02299258|"~     gastric outlet obstruction tailored versus standard stents for malignant gastric outlet~     obstruction treatments~   "
96869|NCT02299245|"~     Coronary heart disease (CHD) is one of the diseases characterised by biological aging as one~     of the important risk factors in several epidemiological studies. The mean telomere length~     and telomerase activity serve as markers for the biological age at the cellular level, with~     shorter telomeres and lower telomerase activity defining the increased biological age.~     Telomere length and telomerase activity, therefore, correlates with the risk of CHD and~     atherosclerosis. A present study states that the treatment with a statin is associated with a~     reduction in the number of clinical events but only in individuals with increased risk based~     on their telomere length. This suggests a positive relationship of telomere and telomerase~     system with the treatment with statins in CHD patients.~   "
96870|NCT02299232|"~     Sixty patients aged between 1-10 years, American Society of Anesthesia (ASA) physical status~     I-II scheduled for MRI were allocated in this randomized double-blinded study. Group 1~     received 3 mcg/kg, Group 2 received 4 mcg/kg intranasal dexmedetomidine before imaging. From~     the beginning on every 10 minutes heart rate (HR), saturation (SpO2) and Ramsey Sedation~     Score (RSS) were recorded. Induction time was time interval to receive RSS 5. MRI began and~     separation-score was noted. If intranasal sedation failed, an intravenous canula was placed~     and propofol was applied. Imaging quality was evaluated. Recovery time was time interval to~     receive Aldrete-score 9. Parents' satisfaction was questioned before patient was discharged.~   "
96871|NCT02299219|"~     Cancer is the most common potentially fatal disease of adolescence and the Internet~     represents an ideal means to deliver education, self-monitoring capabilities, and social~     support to enhance disease self-management by adolescents with cancer. While two interactive~     coping websites exist for young people with cancer, they are: (1) not interactive, (2) do not~     focus on helping youth gain skills for transition and independence, and (3) do not provide~     opportunities for meaningful social support. In summary, there is a crucial need to develop a~     comprehensive interactive Internet-based self-management program targeting AWC that is~     comprised of cancer education, self-management skills, and opportunities for social support,~     and that is cost-effective.~   "
96872|NCT02299206|"~     This is a single-center, 1:1 randomized, double-blind, parallel-group, non-inferiority~     controlled trial to demonstrate non-inferiority of CeraVe Baby Diaper Rash Cream compared to~     Desitin Maximum Strength Original Paste when administered to children with diaper dermatitis~     who are between 3 months to 18 months of age. Parents/caregivers of subjects in both groups~     will administer the product with each diaper change throughout the course of the study~     period. Product can be applied liberally as needed. Diapers and skin cleansing interventions~     will stay constant throughout the treatment period. Subjects will be assessed by the study~     doctor, parent/caregiver will be asked about any adverse effects. Parent/caregivers will also~     be asked to complete a daily diary that asks about changes in their baby's diaper dermatitis,~     a Visual Analogue Scale severity assessment of their baby's diaper dermatitis, and~     observations related to product use and the baby's comfort level. Parents/caregivers will~     also be given a questionnaire rating the use of the study products.~   "
96873|NCT02299193|"~     The purpose of this study is to compare the effect of 6-weekly, 20 minute sessions of 2~     online behavioral sleep interventions (cognitive behavioral therapy or healthy sleep habits)~     on blood pressure, sleep, depressive symptoms and anxiety in people with insomnia and~     prehypertension or hypertension.~   "
96928|NCT02298478|"~     The purpose of this study is to determine the efficacy of a computer-aided self-help~     treatment for flying phobia with or without support by the therapist, compared to a waiting~     list control group.~      Secondary objectives: a) to explore two ways of delivering NO-FEAR Airlines, with or without~     therapist guidance and b) to study the patients' acceptability through expectations,~     preferences and satisfaction towards the online program. In this work, we present the study~     design.~      The principal hypothesis is that the two intervention groups will improve significantly~     compared to the waiting list control group.~   "
97207|NCT02294838|"~     The aim of this study is to determine the feasibility of demonstrating the following~     physiologically-descriptive quantities ('metrics'): the volume of plasma/volume of tissue~     (νp), Apparent Diffusion Coefficient (ADC), the volume of extracellular extravascular space~     per volume of tissue (νe), and the contrast agent transfer coefficients (Ktrans) pre and post~     parotid stimulation in 10 healthy volunteers. Feasibility will be defined as 80% of~     volunteers achieving detectable signal changes in pre/post salivary MR images.~   "
96874|NCT02299180|"~     Aims: Advance care planning (ACP) is considered to be one of the most promising interventions~     to enable patients with life limiting illnesses to receive treatment at the end of life (EOL)~     according to their own preferences and to promote EOL conversations between patients and~     their health care providers. Through a 2-arm randomized controlled trial (RCT) of patients~     with Class III and IV heart failure (New York Heart Association Functional Classification),~     we propose to assess:~        1. Whether patients in the ACP arm have a greater likelihood of receiving EOL care~          consistent with their preferences as stated in the latter of the last ACP document or~          the last patient interview, compared to patients in the control arm.~        2. Heath care costs during study duration between patients in ACP and control arms.~        3. Patient's understanding of own illness and their participation in decision making~          between the ACP and control arms.~        4. Patient's quality of life, anxiety and depression between ACP and control arms.~      Methodology: A total of 254 patients with advance heart failure will be randomized to receive~     intervention (ACP arm; N=127) or usual care (control arm; N=127).~      The RCT will be conducted at the National Heart Centre and Singapore General Hospital.~     Patients in both arms will be followed for one year or till death, whichever is earlier, and~     interviewed every 4 months during this duration.~      Clinical Significance: If benefits of ACP are shown to add value through this trial, then~     this study will help to promote acceptance of ACP among patients and health care providers~     across Singapore and elsewhere.~   "
96875|NCT02299167|"~     The optimal anesthetic technique would provide excellent operating conditions, rapid~     recovery, early discharge, no postoperative side effects, and high patient's satisfaction. In~     addition to increasing the quality and decreasing the costs of the anesthetic services (1).~     Selective spinal anesthesia (SSA) -spinal block with minimal effective doses for a specific~     type of surgery - has become very popular technique) 2(for some orthopedic and gynecological~     surgeries [3-9].~      Saddle anesthesia is a SSA directs a small bolus of hyperbaric local anesthetic, towards~     S4-S5 and coccygeal nerve roots (11), and is commonly utilized for perianal surgeries~     (11-14). Hyperbaric bupivacaine has been safely, replaced hyperbaric Lidocaine for saddle~     block (11, 12).~      Although Saddle blocks at different low doses of hyperbaric bupivacaine (1.5- 4 mg) have been~     used previously for mi¬nor perianal surgeries (11, 13, 14), the optimal effective dose has~     yet to be determined.~      The objective of this study is to determine the minimal effective dose of hyperbaric spinal~     bupivacaine required to induce a reliable and satisfactory saddle block for perianal~     surgeries (using a modified Dixon's up-and-down method.~   "
96876|NCT02299154|"~     This study aims to prospectively examine the memory problem perceptions of patients with~     memory complaints [MCs] and their accompaniers during the diagnostic process.~   "
96877|NCT02299141|"~     There has been limited benefit with angiogenesis inhibitor drugs when used with molecularly~     selected patients in non-small cell lung cancer (NSCLC). The investigators propose that~     patients who are molecularly selected for treatment with nintedanib based on the presence of~     mutations (VEGFR1-3, PDGFR-A, PDGFR-B, and FGFR1-3) will have clinically meaningful benefits~     in terms of response rate (RR) and progression-free survival (PFS). Furthermore the~     investigators plan to perform exome sequencing of paired tumor (pre and post treatment) in~     order to better define molecular marker predictors for response and resistance.~   "
96878|NCT02299128|"~     Therefore, the purpose of this pilot study is to determine the feasibility of conducting a~     randomized clinical trial (RCT) on physical therapist treatment for dizziness after~     sports-related concussion. The specific research question for this pilot RCT is: What is the~     feasibility of conducting a RCT on athletes who have dizziness 10 or greater days after a~     sports-related concussion to explore the effectiveness of directed vestibular rehabilitation,~     neuromotor retraining, and/or manual physical therapy (PT) when compared to sham treatment?~     The findings of this study (for both feasibility and effect size) will be used to inform and~     direct revisions to the methods for a larger RCT on this population.~      Primary Aims:~      Specific Aim 1: Assess the feasibility of the following: recruitment and retention of~     participants, required resources for project management, and assessment of patient safety.~      Specific Aim 2: Estimate the size of the effect between skilled physical therapist~     intervention and a sham treatment for the recovery rate for athletes with a concussion who~     have dizziness 10 - 14 days post-concussion.~   "
96879|NCT02299115|"~     Infantile Spasms, is an rare age-specific epilepsy of early infancy. A 2012 American Academy~     Neurology/ Child Neurology Society practice parameter update on the medical treatment of~     infantile spasms concluded: adrenocorticotrophic hormone or vigabatrin may be offered for~     short-term treatment of infantile spasms. There was insufficient evidence to recommend the~     use of prednisolone, dexamethasone, and methylprednisolone. The cost of ACTH and the side~     effects of vigabatrin have led to the consideration of alternative medications to treat~     infantile spasms. The United Kingdom Infantile Spasms Study (UKISS) in 2004, comparing the~     efficacy of intramuscular synthetic ACTH to high dose oral prednisolone, showed a response~     rate of 74% for ACTH and 70% for prednisolone. Since the UKISS paper was published, many~     institutions in the United States and Australia have used oral prednisolone instead of ACTH,~     partly due to the exorbitant cost of intramuscular ACTH but also its ease of use and better~     adverse event profile compared to ACTH. Prednisolone and vigabatrin are both oral~     medications, which can be initiated promptly upon diagnosis of infantile spasms, expediting~     treatment and shortening treatment lag time. Because the UKISS trial is the only Class 3~     study providing evidence for oral prednisolone in the first-line treatment of infantile~     spasms, further prospective studies are needed.~   "
96880|NCT02299102|"~     This single center, randomized, controlled trial will compare the manual standard bone marrow~     aspiration device to the powered ported bone marrow aspiration device for use in the iliac~     crest in healthy adult volunteers. The study will compare the subjects' perceived level of~     pain, time to sample acquisition, and quality of specimen yield of these devices. To serve as~     their own control, each subject will receive bilateral bone marrow aspiration procedures~     using both the manual standard and powered ported devices.~   "
96881|NCT02299089|"~     This is a Phase II, open-label multicentre, randomised study to assess the PK, PD, efficacy,~     and safety of two dosing regimens of CAM2029 in adult patients with acromegaly or a~     functional, well-differentiated NET, with carcinoid symptoms.~   "
96882|NCT02299076|"~     The purpose of this study is to determine whether a behavioral economics solution impacts~     smoking cessation program engagement and quit rates.~   "
96884|NCT02299050|"~     Purpose This study will examine the effect of the addition of Cycloset upon glucose~     metabolism (glycemic control including post prandial glucose metabolism) in individuals with~     inadequately controlled (HbA1c 7.5-10.0) type 2 diabetes (T2DM) who are already on Bydureon~     (exenatide once weekly) or Victoza (liraglutide once daily) as part of their standard care.~      Both a mechanistic rationale and empirical experimental evidence implicate a beneficial~     interaction between bromocriptine and the incretin mimetics (GLP-1 analogs) upon postprandial~     hyperglycemia in insulin resistant states. One of the actions of the incretin mimetics such~     as the GLP-1 analogs is to stimulate postprandial beta cell insulin secretory response to~     plasma glucose (see drug labeling information; www.fda.gov). Thus the combination of Cycloset~     that is working as a post prandial insulin sensitizier with therapies that increase post~     prandial insulin would be expected to provide complimentary glucose lowering effects. To~     date, however, no such studies investigating the interactive effects of a GLP-1 analog and~     Bromocriptine-QR (Cycloset) have been conducted in humans.~      Condition - Type 2 Diabetes. Intervention - Cycloset. Phase - Phase 4~      Study Type: Interventional Study Design: Treatment, Single Group Assignment, Open Label, N/A,~     Safety/Efficacy Study~      Official Title: Effect of Cycloset on Glycemic Control in Type 2 Diabetic Patients~     Inadequately Controlled on GLP-1 Analogue Therapy~   "
96885|NCT02299037|"~     The purpose of the study is to determine if pre-operative neuropsychological characteristics,~     apolipoprotein E4 status and/or cerebrospinal fluid (CSF) and serum biomarkers can predict~     those most at risk of post-operative delirium. Patients over the age of 65 years undergoing~     elective primary hip or knee arthroplasty in Musgrave Park Hospital are invited to take part.~     Participants undergo a pre-operative neuropsychological assessment which is repeated 6-12~     weeks post-operatively at the time of surgical review appointment. At the time of surgery~     advantage is taken of the necessary venous cannulation and spinal anaesthetic to gain venous~     blood and CSF samples respectively. Venous blood is also sampled post-operatively. Patients~     are assessed daily for delirium, using the Confusion Assessment Method, until discharge.~   "
96886|NCT02299024|"~     The investigators overall study objective is to improve patients knowledge and safe use of~     opioid pain relievers upon discharge from the Emergency Department.~   "
96887|NCT02299011|"~     The primary objective of the BIODEGRADE study is to evaluate clinical efficacy of the Orsiro~     drug-eluting stent compared with Biomatrix drug-eluting stent, both of which have~     biodegradable polymer for the treatment of all-comers' coronary artery diseases.~   "
96888|NCT02298998|"~     This is a two-arm, randomized-controlled pilot study with 2 year duration. The intervention~     refers to surveillance based on the European Association of Urology (EAU) guidelines and the~     control refers to surveillance based on the American Urological Association (AUA)~     guidelines.~   "
96889|NCT02298985|"~     Schizophrenia is still remained one of the disabling disorders despite progress in treatment~     of mental disturbances. Ten to thirty percents of patients have a little or no benefit from~     treatment with all kinds of antipsychotics using adequate dosages and duration. Treatment of~     these patients has remained a persistent public health problem since medication-resistant~     patients are often highly symptomatic. Curcumin is one of the main curcuminoids isolated from~     this perennial herb. It possesses a variety of pharmacological activities, including~     anti-inflammatory, antiproliferative, antioxidant, and neuroprotective effects and crosses~     the blood-brain barrier. The purpose of our suggested study is to examine the efficacy of~     curcumin as add-on the conventional antipsychotic psychopharmacotherapy in chronic~     schizophrenia patients.~   "
96890|NCT02298972|"~     This study evaluates the value of a nursing symptom support en selfmanagement intervention~     for adult patients with cancer treated with chemotherapy. Using a prospective sequential~     design with a comparison group who receives standard care and a (later) intervention group~     who gets the nursing intervention, we will evaluate the effect of this nursing intervention~     on overall symptom distress (primary outcome) and other measures of symptom burden,~     self-efficacy, outcome expectations and self-care. By conducting sem-structured interviews~     with some participants of the intervention group, we will study the patient experience of the~     intervention.~   "
96891|NCT02298959|"~     This phase I trial studies the side effects and best dose of ziv-aflibercept when given~     together with pembrolizumab in treating patients with solid tumors that have spread to other~     places in the body. Ziv-afibercept works by decreasing blood and nutrient supply to the~     tumor, which may result in shrinking the tumor. Monoclonal antibodies, such as pembrolizumab,~     may block tumor growth in different ways by targeting certain cells. Giving ziv-aflibercept~     together with pembrolizumab may be a better treatment for patients with advanced solid~     tumors.~   "
96892|NCT02298946|"~     Background:~      - T-cells are white blood cells that can find and kill germs and tumors. Cancer can keep~     T-cells from working. Researchers think a new drug called AMP-224 might help the T-cells in~     people with cancer. They think the drug might work even better when combined with a certain~     type of radiation therapy.~      Objective:~      - To study the safety and effectiveness of AMP-224 together with 1 or 3 days of stereotactic~     body radiation therapy (SBRT) directed to the liver.~      Eligibility:~      - People age 18 and older with metastatic colorectal cancer. Their cancer must have spread to~     the liver and not be responding to treatment.~      Design:~        -  Participants will be screened with a medical history, physical exam, and blood and urine~          tests. Their tumors will be measured with computerized tomography (CT) scans or magnetic~          resonance imaging (MRI) of the chest, stomach, and pelvis. They will have an~          electrocardiogram (ECG) heart test.~        -  Participants will have a small part of their tumor removed by needle (biopsy).~        -  Participants will have 8 study visits over about 10 weeks.~        -  At 1 visit, they will have another tumor biopsy.~        -  At 1 visit, they will get a chemotherapy drug through a vein (IV).~        -  At 6 visits, they will receive AMP-224 through an IV.~        -  At 1 or 3 visits, they will have SBRT. CT scans will map the position of their tumor.~          Radiation beams of different intensities at different angles will be directed to the~          tumor.~        -  At all visits, some screening procedures may be repeated.~        -  After treatment ends, participants will have 7 follow-up visits over about 5 months.~          Blood will be drawn. Some screening procedures may be repeated.~   "
97476|NCT02291341|"~     This study were to compare the relative bioavailability of Duloxetine HCl delayed release~     capsule 60 mg with that of 'CYMBALTA®' delayed release capsule 60 mg (Duloxetine HCl delayed~     release capsule 60 mg) in healthy, adult, human subjects under fed conditions and to monitor~     safety of subjects~   "
96893|NCT02298933|"~     Background:~      - Platelets are tiny cells in the blood that help stop bleeding. Thrombocytopenia happens~     when people do not have enough normal platelets. Getting a transfusion of another person s~     platelets can help stop too much bleeding. But because these cells are from other people, the~     body may reject them,putting them at risk for serious bleeding complications. This conditions~     is called alloimmune platelet refractoriness . There are evidence that in many patients,~     platelet counts fail to increase after a platelet transfusion because the transfused~     platelets are destroyed by the body s defence soldier, called complement . Researchers want~     to see if a drug, that inhibits complement, can help increase platelet levels and reduce~     bleeding~      Objectives:~      - To see if eculizumab increases platelet levels more after a transfusion. To see if it~     reduces the chance of bleeding too much.~      Eligibility:~      - Adults 18-75 years old who have thrombocytopenia and alloimmune platelet refractoriness.~      Design:~        -  Participants will be screened with medical history, physical exam, and blood tests.~        -  Participants will have the procedures listed below. They can have them while they are in~          the hospital. Or they can go to the outpatient clinic for them. Each visit may take up~          to 3 hours.~        -  Participants will get a meningitis vaccine if needed. Then they will get the study drug~          as an infusion.~        -  Participants will have a platelet transfusion. Their blood will be drawn every 24 hours~          until the platelet count is less than 10,000 per 1 microliter of blood.~        -  They will take antibiotics for 14 days.~        -  Participants will have a checkup and blood drawn twice a week for 2 weeks. They will get~          more transfusions if needed.~   "
96894|NCT02298920|"~     This study will investigate the metabolic fate and routes of excretion of 14CAZD0914 in six~     male healthy volunteers.~   "
96895|NCT02298907|"~     The present study is a retrospective analysis of prospectively collected clinical data.~     Anonymized data from patients collected during routine clinical care from 7 major colorectal~     units in the UK who perform pre-operative cardiopulmonary exercise testing will be pooled at~     a central location (Aintree University Hospitals, Liverpool) and used to validate the~     relationship between cardiopulmonary exercise testing (CPET) variables and short term~     post-operative outcomes after major colorectal surgery. Here the investigators will attempt~     to validate a study entitled Cardiopulmonary exercise variables are associated with~     postoperative morbidity after major colonic surgery - a prospective blinded observational~     study previously published by our team in Liverpool .~   "
96896|NCT02298894|"~     Despite the wide availability of advanced lipoprotein tests, no reference standard exists for~     Low Density Lipoprotein Cholesterol (LDL-C) due to inherent problems with each of the assays.~     Newer methods for estimating LDL particle numbers, including nuclear magnetic resonance (NMR)~     spectroscopy and vertical auto profile (VAP) are currently under investigation. NMR has been~     proposed as having the best correlation with adverse cardiovascular outcomes. Unfortunately,~     the accuracy of LDL-C or LDL particle number measurements is currently not monitored by~     national standardization programs. Direct comparisons between the various testing methods~     have been limited restricting our ability to accurately interpret and compare values across~     vendors and lipid parameters.~      Our hypothesis is that:~        1. LDL particle count numbers, as determined by NMR (Liposcience), provides the best~          estimates of cardiovascular risk.~        2. Discrepancies exist between the LDL particle count by NMR and other values as presented~          by calculated LDLC and directly measured LDL (VAP and ion mobility).~      The investigators will enroll 100 patients recruited from the Lipid Clinic at the Scripps~     Center for Integrative Medicine. Each patient will have one blood draw from which four tests~     will be analyzed. Risks are associated with drawing blood, which will be minimized by using~     Scripps Clinic Lab technicians. The potential loss of personal health information will be~     reduced by limiting access to study and lab staff and keeping information password-protected~     on Scripps servers.~   "
96897|NCT02298881|"~     The purpose of this study is to collect samples from the surface of eyelids to try to grow~     and identify bacteria or fungus that might be present, and to try to understand why people~     have dry eye symptoms.~   "
96898|NCT02298868|"~     The purpose of this study is to determine the safety and efficacy of the medication Baclofen~     for treatment of muscle cramps in patients with cirrhosis.~   "
96899|NCT02298855|"~     The purpose of this study in women who have completed primary treatment for ovarian cancer is~     to investigate the effects of individualised follow-up care delivered by a nurse compared to~     conventional medical follow-up on quality of life and mood. The investigators aim to~     determine if the individualised treatment is acceptable to women compared to the conventional~     treatment.~   "
96900|NCT02298842|"~     This study sought to verify that the in vitro quality (functional assays) of platelets~     collected on the Trima Accel system, Version 6.4, diluted in InterSol Solution, and stored~     for 1, 5, and 7 days meet FDA requirements.~   "
96901|NCT02298829|"~     This a Phase 4 non-treatment, long-term follow-up study of subjects who received AA4500 in a~     12-month double blind placebo-controlled study (AUX CC 803 or AUX-CC-804) or in a 9-month~     open label study (AUX-CC-802 or AUX-CC-806) sponsored by Auxilium Pharmaceuticals, Inc. After~     participation in one of the aforementioned studies, subjects will be followed yearly for up~     to 4 consecutive long-term follow-up visits with at least 6 months between consecutive visits~   "
96902|NCT02298816|"~     The goal of this study is to develop a vaccination registry system for Aurora Health Care~     patients newly diagnosed with MM and other B-Cell Hematologic Malignancies in order to~     prospectively characterize vaccination history and outcomes such as infection in these~     patients at Aurora Health Care. Additionally hospitalization rates, cost analysis, infection~     (influenza, pneumonia, other) related to vaccination in this patient population will be~     evaluated.~   "
96945|NCT02298257|"~     This phase II trial studies the side effects and the best dose of brentuximab vedotin and~     combination chemotherapy work in treating patients with stage III-IV human immunodeficiency~     virus (HIV)-associated Hodgkin lymphoma. Monoclonal antibodies, such as brentuximab vedotin,~     can block cancer growth by finding cancer cells and causing them to die. Drugs used in~     chemotherapy, such as doxorubicin hydrochloride, vinblastine sulfate, and dacarbazine, work~     in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. Giving brentuximab vedotin together with combination~     chemotherapy may kill more cancer cells.~   "
96903|NCT02298803|"~     Hypoglycaemia is the most common acute complication of diabetes and can limit therapeutic~     efforts to improve glycaemic control. It is a potential side effect of drugs used to treat~     diabetes, particularly with the use of sulfonylurea (SU) treatment. It has been demonstrated~     that hypoglycaemia causes the prolongation of corrected QT (QTc) interval, which is~     associated with ventricular arrhythmias and sudden death. Hypoglycaemia in T2DM has recently~     come into focus with the results of the ACCORD, ADVANCE and VADT trials.~      In this study, the investigators aim to examine the association of hypoglycaemia and glucose~     fluctuations on QT-interval and QT variability in patients with type 2 diabetes treated with~     SU. Patients will be studied using simultaneous Continuous Glucose Monitoring (CGM) and~     ambulatory ECG monitoring (Holter).~      Study participants will be recruited from the Diabetes Centre, RPAH or from specialist~     consulting rooms. They will be required to attend the Diabetes Centre on two occasions.~      At the first visit, blood will be collected and CGM and Holter monitoring commenced. At Visit~     2, i.e. two days later, the patient will return to the Diabetes Centre to have the equipment~     removed. The data obtained from the CGM and Holter monitor will then be downloaded for review~     and analysis.~   "
96904|NCT02298790|"~     The goal of this application is to understand the connection between people's eating habits~     and the risk for developing diabetes, obesity, and cardiovascular disease.~   "
96905|NCT02298777|"~     Currently investigators do not have diagnostic and prognostic markers for SSc which almost~     always starts with a vascular disease (Raynaud's disease) isolated for several years.~      The primary purpose is to highlight discriminating metabolic profiles depending on the~     characteristics of the disease, allowing early diagnosis of SSc at the onset of vascular~     lesions, by comparing the profiles of SSc beginners (<3 years) to established forms (> 3~     years).~      Secondary purposes:~        -  Prognosis: to study the metabolomics profile of SSc when a visceral complication occurs~        -  Diagnosis: to compare the metabolomics profile of SSc to undifferentiated connective~          tissue disease (UCDT), Raynaud's disease (RD), vascular disease (VD) and healthy~          controls~        -  Exploratory: to compare the metabolomics profile of blood, urine and skin of SSc~          patients~   "
96906|NCT02298764|"~     Aim The aim is to test whether a short psychotherapeutic intervention targeting Post~     Traumatic Stress Disorder (PTSD) symptoms will have an additional positive effect on the~     outcomes of the Standard Multidisciplinary Program (SMP) against chronic back pain~     development.~   "
96907|NCT02298751|"~     Background: It is well documented that individuals with Alcohol Use Disorder (AUD) respond~     well during evidence-based psychological treatment, but also that a large proportion relapse~     when discharged from treatment and confronted with alcohol in real life. Cue Exposure Therapy~     (CET) focuses on confronting alcohol cues in order to reduce cravings as well as the~     likelihood of relapse. The aim of this study is to investigate whether CET as aftercare~     increases the efficiency of Cognitive Behavioural Therapy (CBT) among AUD individuals.~      Design and methods: The study is implemented as an investigator-blinded randomized controlled~     trial. A total of 300 consecutively enrolled AUD patients, recruited from an alcohol~     outpatient clinic will be randomized to one of the three following aftercare treatment~     groups: (A) CET as a smartphone application (n = 100); (B) CET as group therapy (n = 100),~     and (C) Aftercare as Usual (n = 100). It is hypothesized that the two experimental groups~     ((A) and (B)) will achieve better treatment outcomes as compared to the control group ((C)),~     and It will be explored whether CET as smartphone application is as effective as CET as group~     therapy. The groups will be compared in a number of parameters including alcohol intake,~     cravings and copings-strategies.~      Discussion: If the hypothesis, that CET increases the efficiency of CBT is verified, it will~     make sense to supplement CBT with CET as aftercare, hence, reintegrating CET within a CBT~     approach. Although, CET is most often regarded as one of the behavioral methods in CBT, there~     appears to be segregation in the empirical literature when it comes to treatment of addictive~     disorders. However, CET may allow the patient to practice and gain control over alcohol cue~     reactivity and associated high-risk situations in an inter-mediating therapeutic context~     before the patients inevitably are confronted by them. In this way, one might expect the~     transition from treatment to daily life less overwhelming and CET may help prevent relapse in~     the long term. Thus, CET may be particularly suitable as aftercare.~   "
96908|NCT02298738|"~     Atrial fibrillation (AF), an important cause of cardiac mortality and morbidity is the most~     common type of cardiac arrhythmia in clinical practice. Hypertensive individuals are at~     particular risk of development of atrial fibrillation. Renin-angiotensin-aldosteron system~     (RAS) which is activated in hypertension may be the underlying mechanism of AF among~     hypertensive patients.~      Vitamin D deficiency has been shown to be involved in the pathogenesis of hypertension,~     cardiovascular disease and obesity. Increased RAS activity is one of the postulated~     mechanisms by which vitamin D deficiency may trigger the development of hypertension and~     various cardiovascular diseases. On the basis of these data we hypothesized that~     hypovitaminosis D might be associated with new-onset AF among patients with hypertension.~   "
96909|NCT02298725|"~     To determine if consumption of different diet plans that both are nutritionally-adequate and~     provide energy to maintain body weight, alters fasting insulin concentrations, shifts other~     common clinical markers of metabolic disease risk, and affects metabolomic profiles that~     reflect glucose, lipid, and amino acid metabolism.~   "
96910|NCT02298712|"~     Development of a new MS-based biomarker for the early and sensitive diagnosis of Hurler~     disease from plasma. Testing for clinical robustness, specificity and long-term stability of~     the biomarker.~   "
96911|NCT02298699|"~     Development of a new MS-based biomarker for the early and sensitive diagnosis of Sly disease~     from plasma and saliva. Testing for clinical robustness, specificity and long-term stability~     of the biomarker.~   "
96912|NCT02298686|"~     Development of a new MS-based biomarker for the early and sensitive diagnosis of Sanfilippo~     Type A-B-C-D disease from plasma and saliva. Testing for clinical robustness, specificity and~     long-term stability of the biomarker.~   "
96913|NCT02298673|"~     Development of a new MS-based biomarker for the early and sensitive diagnosis of~     Mucolipidosis Disorder type I, II, III, IV disease from plasma. Testing for clinical~     robustness, specificity and long-term stability of the biomarker.~   "
96946|NCT02298244|"~     Some patients with a long history of AF develops PH reactive type with an increase in~     pulmonary vascular resistance due to vasoconstriction or structural changes of the vascular~     wall. RFA PVI + RFA GP is the gold standard in the treatment of patients with persistent~     AF, do not respond to optimal therapy. The rear area of the pulmonary artery bifurcation is~     adjacent to the roof and part of the front of the left atrium. In the projection of this area~     are ganglionic plexus of the left atrium, the sympathetic nerve fibers of the pulmonary~     artery and baroreceptors main pulmonary artery.Recent studies have shown that radiofrequency~     denervation of the pulmonary artery improves the quality of life in patients with PH.~   "
96914|NCT02298660|"~     The purpose of this study is to investigate the impact of 200 U intradetrusor injected~     OnabotulinumtoxinA (Botox, Allergan, Inc.) (20 sites, trigone sparing) for neurogenic~     detrusor overactivity (NDO) and its role on reducing autonomic dysreflexia (AD) in those with~     chronic, traumatic spinal cord injury (SCI). In clinical practice, urinary bladder~     dysfunctions are commonly associated with episodes of AD. If AD is misdiagnosed or poorly~     managed, it may result in myocardial infarction,stroke, seizure, intracerebral hemorrhaging~     or even death. Reducing AD would dramatically improve the health and well-being of Canadians~     with SCI, and positively impact health care costs. There are an estimated 7,343 hospital~     re-admissions due to SCI-related conditions in Canada every year, with an estimated 5-year~     cost of $661 million. Reducing hospital re-admissions for secondary complications of SCI by~     only 10% over this time period could result in a costs savings of $66 million for Canada.~      Considering these statistics, the present study could be a first attempt to evaluate the~     economic impact of using Botox to manage the urinary bladder following SCI. We will be able~     to examine its impact on episodes of AD and consequently calculate the cost saving for the~     Canadian health system. A significant number of individuals with SCI will require frequent~     emergency room visits due to episodes of uncontrolled AD that originate predominately from~     the urinary bladder. There is clinical evidence demonstrating that costs of bladder~     management following SCI will depend on the understanding of the volumes that the urinary~     bladder can safely hold. This is one of the positive outcomes that have been established in~     previous trials of Botox therapy for the neurogenic bladder.~      Hypothesis: 200 U of intradetrusor injected Botox (20 sites, trigone sparing) for neurogenic~     bladder detrusor hyperreflexia will decrease the severity of AD in individuals with SCI one~     month following treatment.~   "
96915|NCT02298647|"~     Development of a new MS-based biomarker for the early and sensitive diagnosis of~     metachromatic leukodystrophy disease from plasma and saliva. Testing for clinical robustness,~     specificity and long-term stability of the biomarker.~   "
96916|NCT02298634|"~     Development of a new MS-based biomarker for the early and sensitive diagnosis of Farber~     disease from plasma and saliva. Testing for clinical robustness, specificity and long-term~     stability of the biomarker.~   "
96917|NCT02298621|"~     The effect of pomegranate juice (PJ) intake on cardiovascular risks in subject with metabolic~     syndrome.~   "
96918|NCT02298608|"~     Background:~      Electroporation or electropermeabilisation is a novel technique with the potential to~     overcome the main disadvantages of thermal ablation. It utilizes electric pulses, traveling~     between two or more electrodes, to create 'nanopores' in the cell membrane. If the applied~     current reaches a certain threshold these 'nanopores' become permanent resulting in cell~     death. The use of electric current means that IRE is not susceptible to 'thermal sink'~     leading to consistent ablation results. IRE ablation targets the cell membrane, sparing~     tissue architecture and minimizing damage to blood vessels, nerves and the renal collecting~     system.~      The first in human studies have proven the safety of IRE for the ablation of small renal~     masses. However the efficacy of IRE through histopathological examination of an ablated renal~     tumour has not yet been studied, compromising the correct and scientific evaluation of this~     new technology.~      Primary Objectives:~        -  To determine the efficacy of IRE ablation of renal masses , measured by histopathologic~          examination of the targeted tumour.~        -  To determine the safety of IRE ablation of renal masses, by evaluating device and~          procedural adverse events.~      Secondary Objectives:~        -  To evaluate the efficacy of MRI in the imaging of ablation success, extend of the~          ablation zone, one and four weeks post IRE ablation.~        -  To evaluate the efficacy of CEUS in the imaging of ablation success, extend of the~          ablation zone, one and four weeks post IRE ablation.~      Population:~      10 patients, age ≥ 18 years, presenting with a solid enhancing mass, who are candidates for~     radical nephrectomy.~      Intervention:~      Eligible patients will receive IRE ablation of their renal mass 4 weeks prior to radical~     nephrectomy. Follow-up at one and four weeks post IRE will be performed using MRI and CEUS~     imaging. After radical nephrectomy histopathological examination will be performed to~     evaluate IRE ablation success.~   "
96919|NCT02298595|"~     This study evaluates the combination of BYL719, cisplatin and cetuximab as induction~     chemotherapy prior to minimally-invasive transoral surgery (TORS or TLM) and selective lymph~     node dissection (SLND), followed by risk-adapted intensity-modulated radiation therapy (IMRT)~     in patients with transorally resectable, Stage III-IVa, HPV-associated oropharyngeal squamous~     cell carcinoma (OPSCC).~   "
96920|NCT02298582|"~     The purpose of this study is to evaluate the safety of the intranasal fentanyl in pain~     induced by wound care and rehabilitation in the elderly. The project would also provide a~     preliminary assessment of the effectiveness of intranasal fentanyl used in procedural pains.~   "
96921|NCT02298569|"~     The purpose of this before-after study is to determine the effectiveness of a~     multidimensional intervention to increase the rate for early discharge of low-risk mothers~     and the healthy newborn in a perinatal network.~   "
96922|NCT02298556|"~     To describe the effectiveness of angiotensin-converting enzyme inhibitor and~     non-dihydropyridine calcium channel blocker single pill combination on systolic blood~     pressure (SBP) lowering in hypertensive patients with elevated heart rate and type 2 diabetes~   "
96923|NCT02298543|"~     The purpose of this study is to evaluate the natural course of coronary spasm patients~     presenting aborted sudden cardiac death and analyze risk factors.~   "
96924|NCT02298530|"~     Assess the effects of adding theanine to a caffeinated beverage on changes in blood pressure~     during acute mental stress.~   "
96925|NCT02298517|"~     The aim of this study is to evaluate the effects of the use of breathing exercises with~     inspiratory loading on respiratory muscle strength and endurance, lung volumes and capacities~     and thoracoabdominal mobility in patients after bariatric surgery.~      It is believed that the use of inspiratory load may mitigate the negative effects of surgical~     trauma on respiratory muscle dysfunction, preserving respiratory muscle strength, lung~     volumes and diaphragm mobility, thus reducing the risk of pulmonary complications in the~     postoperative period.~   "
96926|NCT02298504|"~     In primary teeth, decay that is near the pulp (tooth nerve)is treated with either a pulpotomy~     or indirect pulp treatment if the tooth is not going to be extracted A pulpotomy involves~     removing the top 1/2 of the pulp, placing a medication/material on the pulp, covering the~     remaining pulp with a cement, and the restoring the tooth. The purpose of this pilot study is~     to gain preliminary information regarding the success of Biodentine, MTA, and IPT in the~     treatment of deep decay in children's primary molars.~   "
96927|NCT02298491|"~     The purpose of this study is to see if treatment with H.P. Acthar® Gel will result in the~     improvement and long-term stabilization of clinical and radiographic abnormalities that occur~     in patients with CNS sarcoidosis. In addition, it will also look at whether treatment will be~     also associated with improvement in measures of quality of life. The treatment of CNS~     sarcoidosis involves the use of either corticosteroids such as prednisone or potent~     immunosuppressive agents such as methotrexate, both which can induce severe long term side~     effects. The adverse effects of steroids may be avoided by treatment with adrenocorticotropic~     hormone (ACTH), which is available for patient use as H.P. Acthar® Gel. The efficacies of~     H.P. Acthar® Gel in the treatment of CNS sarcoidosis and the impact on quality of life have~     not been previously studied. In addition, little is known regarding the expression of immune~     markers in CNS sarcoidosis and the association of such markers with disease activity and~     response to treatment.~   "
96929|NCT02298465|"~     Extracorporeal shockwave lithotripsy (ESWL) for urinary stone is common and widespread~     nowadays. Approximately 80% of urinary stones are treated by ESWL. Traditionally distal~     ureteric stones are treated with ESWL in the prone position. However, as some patients cannot~     tolerate lying in the prone due to medical illness such as chronic obstructive pulmonary~     disease (COPD), some authors have reported using the supine approach of ESWL for treatment of~     distal ureter stones. No serious complications had developed in the patients who underwent~     supine approach. Only minor complications such as self-limiting blood in the urine, painful~     passage of urine, or local pain that had responded to oral painkillers. There were no serious~     complications encountered in children as well. In the most recent retrospective review by~     Tolley et al, they had revealed that patients who had underwent supine ESWL for distal~     ureteric stones had an improved stone-free rate compared with the traditional prone approach.~      Patient with radio-opaque distal ureteric stones (stones below the sacroiliac joint) on KUB~     X-ray, who have opted for ESWL treatment, are randomized into two groups: one undergoing ESWL~     in the supine position and the other undergoing ESWL in the prone position. Patients will be~     observed for two hours after ESWL before being discharged. Oral painkillers as necessary will~     be provided to the patient. The patients will have a KUB Xray at 2 weeks post-ESWL, and then~     monthly afterwards if required. If there are residual stones at the 2-week follow-up, the~     patient will be offered ESWL again. Patients are free to withdraw from the study at any time~     and will continue to be managed as per usual.~      The investigators aim to have 130 patients, with 65 patients in each group with an interim~     analyses to be performed when 66 patients have been recruited (33 patients in each group).~   "
96930|NCT02298452|"~     The reason for this study is to evaluate a new hearing aid product generation replacing the~     one on the market. The goal is to evaluate the audiological performance, usability as well as~     features and functions.~   "
96931|NCT02298439|"~     The purpose of the Non-Alcoholic Fatty Liver Disease (NAFLD) registry is to collect~     demographic and clinical data on patients being treated for NAFLD and to determine the~     factors affecting the progression of the disease as well as the success of different~     treatment strategies.~   "
96932|NCT02298426|"~     This study aims to explore the effectiveness of body constitution classification based~     comprehensive health management intervention on obese population.~   "
96933|NCT02298413|"~     The investigators aim at evaluating the long-term (5-year) clinical outcome following Absorb~     BVS implantation in a real world, all-comers population of consecutive patients, as treated~     according to the indications, techniques and protocols used in the participating~     institutions.~   "
96934|NCT02298400|"~     The purpose of this study is to compare the comfort of three commercially available contact~     lenses.~   "
96935|NCT02298387|"~     This is an open-label Phase 1 dose escalation and expansion study of OMP-305B83 in subjects~     with previously treated solid tumors. Study includes a dose escalation phase and expansion~     phase. Subjects will be assessed for safety, immunogenicity, pharmacokinetics, biomarkers,~     and efficacy.~   "
96936|NCT02298374|"~     The aim is to evaluate a model of home-based rehabilitation. The intervention targets elder~     persons who receive homecare services, but still are relatively independent in most~     activities of daily living. The model focuses on early identification of decline in function~     and intervention in the home environment through close cooperation between the participant,~     homecare services and therapists.~   "
96937|NCT02298361|"~     Health insurance is important for children. Public insurance programs are available to many~     children, but some families report being confused about how to get and keep this insurance.~     Community Health Centers (CHCs) can help families get and keep health insurance for their~     children.~      The investigators will work with families, policy makers, and community health care providers~     and staff to develop and test new computer health information technology (IT) tools to help~     health care clinics find pediatric patients in need of insurance and communicate with their~     families about public insurance programs. These tools will be based on technologies currently~     used to help patients and clinics manage chronic diseases. The investigators will test the~     tools by comparing four clinics using the tools and four clinics not using the tools. The~     investigators will look to see if children in the clinics using the tools are more likely to~     have health insurance and also more likely to receive certain health care services, compared~     to children in the clinics without such tools. The investigators will also look at health~     insurance rates and health care services for a larger population of Oregon children.~   "
96938|NCT02298348|"~     This study will combine three drugs: sorafenib, cyclophosphamide and topotecan.~      Adding sorafenib to cyclophosphamide and topotecan may increase the effectiveness of this~     combination. The investigators first need to find out the highest dose of sorafenib that can~     be given safely together with cyclophosphamide and topotecan. This is the first study to test~     giving these three drugs together and will help determine the highest dose of sorafenib that~     can safely be given together with cyclophosphamide and topotecan to patients with~     resistant/relapsed neuroblastoma.~   "
96939|NCT02298335|"~     This study is to assess the efficacy and safety of 8-weeks full-dose induction protocol~     (prednisone 1mg/kg, maximum 60mg/day) and protracted tapering protocol in the treatment of~     adult idiopathic nephrotic syndrome.~   "
96940|NCT02298322|"~     Study to Evaluate Non-Invasive Subcutaneous Fat Reduction in the Submental Area using~     Cryolipolysis. Healthy adult men and women with submental skin fold thickness > 1cm who~     desire reduction of submental fat.~   "
96941|NCT02298309|"~     The purpose of this study is (1) to establish the feasibility, yield, and clinical impact of~     a Test & Treat TB strategy on a mobile HIV screening unit in South Africa and (2) to assess~     the cost and cost-effectiveness of this mobile, integrated HIV/TB screening strategy for~     maximizing linkage to TB care and treatment completion.~   "
96942|NCT02298296|"~     The purpose of the study is to to determine the natural history of positive psychological~     states, health status, and functioning, over an 8 week period following admission for an~     acute coronary syndrome (ACS). We aim to compare the changes in these factors from baseline~     to 8-week follow-up with corresponding changes in the completed proof-of-concept intervention~     trial (NCT02004158).~   "
96943|NCT02298283|"~     This study aims to evaluate the efficacy brentuximab vedotin as consolidation treatment in~     patients with stage I/II Hodgkin's lymphoma and 18-fluorodeoxyglucose (FDG) -PET positivity~     after 2 cycles of ABVD (adriamycin, bleomycin, vinblastine, and dacarbazine).~   "
96944|NCT02298270|"~     This study tests the efficacy of an 8-week, Skype-based, group resiliency training~     intervention (The Relaxation Response Resiliency Program) for improving psychological stress~     in patients with Neurofibromatosis. A control group will receive a general health education~     curriculum. The investigators hypothesize that patients will improve on measures of~     psychological stress as a result of the resiliency program.~      A substudy (Unique Protocol ID: 2013P002605b) has been approved to test this study on a~     sub-population: patients with NF2 who are hard of hearing.~   "
96948|NCT02298218|"~     In this clinical study, meloxicam will be used to the patients who are older than 2 years and~     underwent Kasai portoenterostomy to treat their biliary atresia before. Before and after the~     medication, their liver stiffness scores will be checked using hepatic Fibroscan. Liver~     stiffness scores will be compared before and after the medication of meloxicam, and the roll~     of the COX-2 inhibitor (meloxicam) in the patients with biliary atresia in releasing their~     hepatic fibrosis. Also, the side effect of the drug will be checked. The intervention drug,~     meloxicam is safe medicine which is used to treat pain or inflammation caused by~     osteoarthritis or rheumatoid arthritis in adults and children who are at least 2 years old.~     It may also be used for purposes not listed in the medication guide. It will be taken once a~     daily with a dose of 0.125 mg/kg/day (high-dose group) or 0.06 mg/kg/day (low-dose group).~     After 6 months of medication, the maintenance will be decided by the comparison of liver~     stiffness score before and after the intervention.~   "
96949|NCT02298205|"~     African American (AA) children carry a disproportionate burden of mortality and morbidity in~     asthma. A major contributor to racial disparity in asthma is lack of adherence to~     guideline-recommended use of daily inhaled corticosteroids (ICS). Symptom-based adjustment~     (SBA) of ICS is a recently described patient-centered approach to asthma therapy in which~     patients adjust their ICS on a day-to-day basis guided by their symptoms. The overall goal of~     our study is to identify an acceptable, pragmatic and effective approach to asthma management~     in high-risk AA children. Our primary hypotheses are that SBA of ICS use is more acceptable~     than provider-based adjustment (PBA), equally effective in improving pediatric asthma~     outcomes, and will reduce the cumulative dose of ICS needed for asthma control. Therefore, in~     the Asthma Symptom based adjustment of Inhaled Steroid Therapy in African American children~     (ASIST) study, we propose a randomized, open-label, 2-arm, parallel, pragmatic trial in which~     we will randomly assign 200 AA children to either receive SBA or PBA for 12 months. The~     primary outcome is asthma control as measured by the Asthma Control Test (ACT). We propose~     that asthma control in the SBA group will be equivalent to the PBA group after 12 months.~     Secondary outcomes include monthly cumulative ICS dose, exacerbation rate, quality of life,~     lung function, adherence and satisfaction with the treatment plan.~   "
96950|NCT02298192|"~     This trial is conducted in Europe, North America and the United States of America.~      The aim of this trial is to compare two different titration algorithms of insulin~     degludec/liraglutide.~   "
96951|NCT02298179|"~     The purpose of this study is to evaluate the safety and immunogenicity of two doses of the~     investigational RSV F subunit vaccine administered intramuscularly (IM). In this current~     Phase 1, first-in-human study, the three different antigen amounts that have been selected~     will be evaluated in a stepwise manner in three different cohorts (cohort 1: low dosage of~     RSV F subunit vaccine, cohort 2: middle dosage of RSV F subunit vaccine, and cohort 3: high~     dosage of RSV F subunit vaccine). In addition, the effect of an adjuvant, either aluminum~     hydroxide or MF59, and antibody kinetics post-vaccination at different time points will be~     evaluated as compared to unadjuvanted RSV F subunit vaccine at the same dosage levels~   "
96952|NCT02298166|"~     The main trial is a double-blinded, placebo-controlled, randomized, phase III, multi-center~     trial in adult patients with relapsed or refractory AML harboring an activating FLT3 mutation~     as defined in the inclusion /exclusion criteria.~      An initial open label dose-finding run-in phase I of the study will be performed~     administering the study drug crenolanib with salvage chemotherapy consisting of mitoxantrone~     and cytarabine (MC) in 18 patients according to the experimental arm of the study. After~     completion of this dose-finding run-in phase I, toxicity and response data will be provided~     to the external Data and Safety Monitoring Board (DSMB) and the Trial Committee by the~     Coordinating Investigator. The Trial Committee will decide on the basis of these data and the~     recommendation of the DSMB on dose modification and the further conduct of the study with~     regard to the double-blinded, placebo-controlled, randomized phase of the study.~      The double-blinded, placebo-controlled randomized portion will start after the completion of~     the dose-finding run-in phase I and positive opinion of the Trial Committee.~      Crenolanib starts on day 7 of MC and is given continuously until 48 hours prior to the next~     chemotherapy; if receiving allogeneic HCT, crenolanib is held 48 hours prior to conditioning~     and restarts no sooner than 30 days and not later than day 100 after transplant.~      Sample size randomized phase: 276 patients~      Primary objective: To evaluate the impact of crenolanib given in combination with salvage~     chemotherapy and consolidation including allogeneic hematopoietic cell transplantation and~     ongoing single agent maintenance therapy with crenolanib on event-free (EFS) and overall~     survival (OS) in adult patients with relapsed or refractory AML harboring FLT3 activating~     mutations.~   "
96953|NCT02298153|"~     This study will evaluate the safety and tolerability of epacadostat (INCB024360) administered~     in combination with atezolizumab (MPDL3280A) in patients with locally advanced or metastatic~     non-small cell lung cancer (NSCLC) that have been previously treated with platinum-based~     chemotherapy and Stage IV urothelial carcinoma who have failed a platinum-based chemotherapy~     regimen. The study will be conducted in two phases. The dose escalation phase will utilize a~     3 + 3 design to identify the maximum tolerated dose (MTD) or a Pharmacologically Active Dose~     (PAD) of the combination. This will be followed by a dose expansion phase, which will be~     comprised of three cohorts. Expansion Cohorts 1 & 2 will further evaluate the safety,~     tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics at the dose identified in~     phase one. Expansion Cohort 3 will evaluate the change in biomarker expression following~     treatment with epacadostat as monotherapy followed by epacadostat and atezolizumab~     administered in combination.~   "
96985|NCT02297737|"~     This study evaluates the feasibility and acceptability of a 12-week Tai Chi intervention for~     patients who have recently had a heart attack and are not participating in a standard cardiac~     rehabilitation program. Half of the 75 patients will be randomly assigned to the Tai Chi~     condition and the other half will be assigned to 12 weeks of Health Education. In addition to~     examining feasibility and acceptability, the investigators will evaluate the impact of~     participation in the Tai Chi condition on measures of cardiac health, physical function,~     self-reported health behaviors, and mental health as compared to Health Education within the~     context of this developmental/exploratory study.~   "
96954|NCT02298140|"~     INDEPTH Network Effectiveness and Safety Studies in Africa (INESS) have demonstrated a~     substantial efficacy decay of Artemisinin based combination therapy (ACT) in Tanzania in 2012~     (from efficacy of 98% to effectiveness of 18%). Hence system readiness for control and~     elimination strategies is severely compromised. Sub-optimal health workers' performance in~     treating malaria cases was a major contributor to the decay, effecting both treatment and~     patient adherence. If these quantified system failures remain unchecked it will pose major~     barrier in achieving malaria control and elimination goals. There is growing evidence that~     mobile phone text message reminders can improve health workers' compliance and patients'~     adherence to malaria treatment guidelines. Tanzania has recently harnessed all public sector~     health worker phones into Short Message System (SMS) platform. The investigators intend to~     exploit this opportunity in a randomized trial of messages to substantially reduce the decay~     documented by the INESS platform.~      The null hypothesis: Sending automated text message reminders to health workers on malaria~     diagnosis and treatment recommendations, will not have any effects in the quality of malaria~     case management.~   "
96955|NCT02298127|"~     The purpose of this study is to evaluate the potential efficacy of auricular acupressure to~     stimulate specific acupoints in enhancing smoking cessation by reducing nicotine withdrawal~     symptoms among attendees in primary healthcare settings.~   "
96956|NCT02298114|"~     Neuromuscular electrical stimulation in pectoral muscles (fibres of the pectoralis major~     muscle bilaterally) and rectus abdominis muscles (bilaterally) preserves / decreases the loss~     of muscle mass.~   "
96957|NCT02298101|"~     Aeroneb Solo Adapter is a vibrating-mesh nebulizer Aeroneb Solo combined to a spacer~     specifically designed for spontaneously breathing patients. This device has not been~     investigated in vivo yet.~      It's known that using a spacer during nebulization improves aerosol delivery. We hypothetized~     that lung deposition could be highly increased with the Aeroneb Solo Adapter in comparison to~     a standard jet nebulizer.~   "
96958|NCT02298088|"~     Administration of Ticagrelor in patients with ST elevation myocardial infarction treated with~     pharmacological thrombolysis~   "
96959|NCT02298075|"~     The primary objective of the study is the evaluation of sustained response rate after~     discontinuation of treatment with TPO-RAs, Eltrombopag and Romiplostim, in persistent or~     chronic pITP patients who failed one or more therapy lines, splenectomy included.~   "
96960|NCT02298062|"~     The objective of this study is to investigate the effect of infliximab to the children who~     don't respond to the first dose of intravenous immunoglobulin (IVIG) (2g/kg) in Kawasaki~     disease.~   "
96961|NCT02298049|"~     To our knowledge no study has assessed the effects of a meal on neural responses to food cues~     and compared this with a condition simulating natural inter-meal hunger levels. This is~     important, as the existing literature often compares the effect of fasting to satiation,~     which may not reflect typical appetite processes. Thus, the purpose of this research was to~     examine the effect of a satiating lunch compared to a normal pre-meal state on blood oxygen~     level dependent (BOLD) activity in the human brain, as measured using functional magnetic~     resonance imaging (fMRI).~   "
96962|NCT02298036|"~     To determine the cost and clinical effectiveness of offering 6-10 sessions of remotely~     delivered cognitive behaviour therapy (CBT) via video calling or over the telephone for~     health anxiety in repeated utilisers of unscheduled/urgent care versus treatment as usual.~      To optimise the delivery of CBT for health anxiety delivered remotely by systematically~     identifying and then acting on barriers and enablers to the intervention through a network of~     practice.~   "
96963|NCT02298023|"~     Main purpose of this study is to evaluate efficacy of allogenic adipose-derived mesenchymal~     stem cells in treatment of tendon injury. ALLO-ASC will be administrated to the patients with~     supraspinatus partial thickness tear by ultrasonographic guided injection.~   "
96964|NCT02298010|"~     The pattern of lymph node metastasis of the gastric cancer to each geographic lymph nose~     stations and the relation between each metastasis and survival are to be analyzed by~     retrospective review of medical records of who enrolled in the CLASSIC trial (NCT00411229)~     which have compared adjuvant chemotherapy and no adjuvant therapy after radical gastrectomy~     with extended lymphadenectomy.~   "
96965|NCT02297997|"~     This study is to assess the impact on the prevention of sarcopenia after taking~     cetylpyridinium chloride targeting the patients of presarcopenia over the age of 60.~   "
96966|NCT02297984|"~     Neuroglobin has shown rich neuroprotective effects against cerebral ischemia and hypoxia, and~     therefore has the potential to impact outcomes after acute ischemic stroke. Hypoxia inducible~     factor (HIF)-1α is neuroprotective in several models of experimental brain injury and is~     increased in brain after acute cerebral infarction in humans and experimental animals.The~     investigators sought to examine the changes in serum neuroglobin and HIF-1α concentrations in~     patients with acute ischemic stroke during the initial 96-h period after stroke and assessed~     the relation between them and the relation of them to prognosis of such patients with acute~     ischemic stroke.~   "
96967|NCT02297971|"~     When ticagrelor should be discontinued prior to elective surgery is unclear. The risks of~     bleeding when it is continued peri-operatively have to be weighed against the risk of~     coronary artery thrombosis when stopped. This study aims to assess coagulation and~     thrombocyte function every other day in patients who are taking ticagrelor after coronary~     artery stents and discontinue therapy at the end of one year.~   "
96968|NCT02297958|"~     Ovarian carcinoma has poor prognosis and new therapeutic strategies are required. Many~     patients with ovarian carcinoma showed resistance to chemotherapy. Cleaved FasL is known for~     induced atypical response when is binding to Fas such as avoiding apoptosis and inducing cell~     motility.~   "
96969|NCT02297945|"~     The purpose of this prospective, international phase III/IV study is to assess the efficacy~     and safety of metyrapone in patients with endogenous Cushing's syndrome during up to 36 weeks~     of treatment. The ability of metyrapone (250 mg capsules) to normalize urinary free cortisol~     (UFC) levels will be assessed during up to 36 weeks (9 months) of treatment.~   "
97050|NCT02296892|"~     A prospective, double-blind, randomized, placebo and active controlled, multi-center,~     parallel group study comparing remimazolam to placebo, with an additional open label arm for~     midazolam, in patients undergoing a bronchoscopy.~   "
96970|NCT02297932|"~     Physical activity and exercise interventions in multiple sclerosis (MS) have received great~     attention most recently and there exists several randomized clinical trials (RCTs) addressing~     the outcomes associated with such intervention. The majority of such interventions have~     primarily focused on directly influencing disease processes (e.g., inflammation, neurotrophic~     factors), the reduction of symptoms (e.g., fatigue, depression), improvement in physical~     functioning (e.g., gait, strength) or enhancing one's quality of life. To date, the evidence~     suggests that exercise intervention in MS holds anywhere from minimal to great promise~     depending on the outcome of interest. For some outcomes such as depression or cognition,~     findings are even less optimistic, being null, or inconsistent, at best. These inconsistent~     findings may be attributed to methodological issues such as use of subjective reports, lack~     of appropriate control group, poor compliance, and sample selection. The proposed~     investigation aims to address some of these issues by: (1) Obtaining objective measures of~     outcomes of interest (i.e., fatigue, cognition, and participation/activities of daily living~     [ADLs]) and; (2) assessing certain person-specific factors (e.g., personality) and~     intermediary factors that may be influenced by physical activity and indirectly result in~     improved outcomes (e.g., improvement in sleep and subsequent improvement in fatigue and/or~     cognition). Thus, the primary objective of the proposed investigation is to: (1) utilize~     innovative and objective measures of outcomes and; (2) obtain comprehensive assessment of~     intermediary variables (e.g., sleep) or person-specific characteristics (e.g., personality),~     which together may explain the inconsistent findings in the literature and has the following~     specific aims:~      To achieve these goals, individuals will complete a comprehensive assessment of cognition,~     person-specific factors, intermediary factors, physical fitness, and functional magnetic~     resonance imaging (fMRI) prior to and following a home based exercise intervention.~   "
96971|NCT02297919|"~     The purpose of this study to create an educational portal Genç (e) sağlık in an attempt to~     develop a healthy eating habit, increase physical activity and reduce sedentary behavior in~     order to prevent to overweight gain which is school-based approach in adolescents and there~     with also test the level of program information and the behavioral alterations of~     effectiveness.~   "
96972|NCT02297906|"~     Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) that is typically given to both~     adults and children by the intravenous (IV) or intramuscular (IM) route for analgesic~     purposes. Ketorolac can also be given by the intranasal (IN) route using a mucosal~     atomization device (MAD). We aim to study the pharmacokinetics of ketorolac when administered~     by the IN route using the MAD.~   "
96973|NCT02297893|"~     Background and aim: Patients with Parkinson's disease (PD) exhibit disturbed manual~     dexterity. This impairment leads to difficulties in activities of daily living (ADL) such as~     buttoning a T-shirt or hand-writing. The aim of the present research project is to~     investigate the effectiveness of a high intensity home based exercise intervention focusing~     on fine motor skills (HOMEDEXT), in patients with PD.~      Design: A single blinded randomized controlled trial (RCT) will be performed. Randomization~     will be done by an independent biostatistician who will use a computerized randomization~     protocol. A baseline assessment and a follow-up measurement 4 weeks immediately after~     intervention (end of rehabilitation) will be performed. A follow-up measurement, 12 weeks~     later, will be done to assess long-lasting effects. Assessments will be performed by~     investigators who are blinded for the intervention.~      Participants: One hundred and four out-patients with PD will be recruited who report specific~     difficulties in manual dexterity when executing ADL. Intervention: The patients will be~     allocated to either an intervention group (n = 52) or control group (n = 52). In the~     intervention group PD patients will exercise, over a period of four weeks, once/day during 30~     minutes a treatment with specific exercises for dexterity. The PD patients, who will be~     allocated to the control group, will exercise Theraband exercises.~      Outcome measures: The primary outcome measures for manual dexterity will be the Nine Hole Peg~     test. Secondary outcome measures will be the Coin Rotation task, a sensitive screening for~     dexterity. Furthermore for ADL a modified version of the subscale II of the Movement~     Disorders Society unified Parkinson's Disease Rating Scale (MDS-UPDRS) will be used.~     Parkinsonian symptoms will be assessed by the MDS-UPDRS subscale III. To assess improvements~     in quality of life a modified version of the Parkinson's Disease Questionnaire (PDQ-39) will~     be used.~   "
96974|NCT02297880|"~     Although there is evidence that low calorie sweeteners (LCS) do not stimulate hunger or~     appetite, divergent opinions appear regularly both in the scientific literature and in the~     popular press. The goal of this study is to examine the effects of LCS containing beverages~     on appetite and intake in healthy individuals.~   "
96975|NCT02297867|"~     The aim of the investigators study was to investigate the safety and efficacy of autologous~     ADSCs for the clinical treatment of liver cirrhosis.~   "
96976|NCT02297854|"~     This study is to assess the Valganciclovir Hydrochloride Tablets 450 mg of Dr. Reddy's~     Laboratories Limited, India and Valcyte® (Valganciclovir HCl) tablets 450 mg of Genentech USA~     Inc., Group of Roche, South San Francisco in healthy, adult, human subjects under Fasting~     conditions.~   "
96977|NCT02297841|"~     Determine the ability of the study material (personal lubricant) to cause sensitization by~     repeated topical application to the skin of humans under controlled patch test conditions.~   "
96978|NCT02297828|"~     The purpose of this study is to determine if the application of Boussignac continuous~     positive airway pressure (CPAP) immediately after extubation improves PaO2 and PaO2/FiO2~     ratio in morbidly obese patients undergoing gastric bypass surgery .~   "
96979|NCT02297815|"~     The purpose of this study is to identify and use patient centered outcomes to compare~     narrow-spectrum and broad-spectrum antibiotics for the treatment of common acute respiratory~     tract infections (ARTIs) in children.~   "
96980|NCT02297802|"~     The purpose of this study is to provide access for a single patient to PD-0325901 who was~     previously enrolled in a phase I clinical trial.~   "
96981|NCT02297789|"~     Currently Fisher & Paykel Healthcare (FPH) is developing a new full face mask. The objective~     of this clinical investigation is to evaluate the usability and acceptance of the~     investigative mask, the effectiveness of the seal and headgear.~      The participant will be randomised to use either full face mask prototype 1 or 2 as according~     to the randomization log for 7 ± 3 days in home. The participant will then crossover to the~     other full face mask prototype to use in home for 7 ± 3 days. Neither the investigators or~     the participants will be blinded to the study.~   "
96982|NCT02297776|"~     Prediction of clinical outcome after cardiac arrest is clinically important.Early~     prognostication after successful cardiopulmonary resuscitation is difficult, and there is a~     need for novel methods to estimate the extent of brain injury and predict outcome. In this~     study, the investigators will evaluate the plasma levels of microRNAs (miRNAs) and circRNAs~     after cardiac arrest and assessed their ability to prognosticate neurological outcome.~   "
96983|NCT02297763|"~     The purpose of this study is to evaluate the efficacy of low dose quetiapine for the~     prophylaxis of delirium in critically ill patients in medical intensive care unit.~   "
96984|NCT02297750|"~     The purpose of this study is to give doctors who perform Endoscopic Retrograde~     Cholangiopancreatography (ERCP) procedures a better idea as to the best techniques to use in~     order to examine the bile duct as quickly and safely as possible.~   "
97065|NCT02296684|"~     The goal of this trial is to test the ability of MK-3475 (pembrolizumab) to improve~     locoregional recurrence and distant metastatic rates in high-risk patients with locally~     advanced head and neck squamous cell carcinomas (HNSCCs) that are treated with current~     standard of care surgical approaches.~   "
96986|NCT02297724|"~     The ultimate goal of this project is to develop methods that allow informed decision-making~     on the delivery time of fetuses that are at increased risk of stillbirth due to IUGR. In~     placenta related IUGR pregnancies, there can be multiple concurrent placental pathologies.~     Although there is no specific correspondence between a single type of pathology and IUGR, the~     common result of these pathologies is placental insufficiency, which limits the~     maternal-fetal exchange. Oxygen and nutrition transport is known to be hindered in IUGR~     placentas due to obstructed or abrupt vasculature, massive fibrin deposition, and~     inflammation in the villous and intervillous space (villitis). Thus one potential approach to~     distinguish IUGR pregnancies from normal ones is to assess the efficiency of placental~     transport. Based on the hypothesis that efficiency of oxygen transport is representative for~     overall oxygen and nutrition transport in placenta, the investigators propose to characterize~     the blood oxygenation and blood perfusion in placenta in vivo via MRI, and use it as an index~     for better stratification in the IUGR risk group. The investigators will also consider~     alternative MRI approaches such as structural, diffusion and spectroscopy measurements inside~     the placenta, which might reflect the state of placental transport and reveal the status of~     placental health.~      Specific aims: 1) To correlate the MRI metrics that differentiate placental insufficiency~     from normal placenta transport with histopathology data of the placenta. 2) To correlate the~     MRI metrics that reflects placental insufficiency with fetal outcome~   "
96987|NCT02297711|"~     Sportsman's hernia is defined as a weakness or disruption of the posterior wall of the~     inguinal canal. Open hernia repair with or without mesh or laparoscopic techniques with mesh~     have been advocated in the treatment of sportsman's hernia and associated athletic pubalgia.~     The results of the operative treatment from single centers are reported to be good to~     excellent in between 70 - 90% of patients with the most promising results reported using an~     open minimal repair (OMR) technique. There are no randomized trials comparing open versus~     laparoscopic techniques regarding time for recovery and relief of pain. The aim of this~     randomized study is to compare the effectiveness of OMR technique in local or spinal~     anesthesia to endoscopic Total ExtraPeritoneal (TEP) technique in general anesthesia for the~     treatment of Sportsman´s hernia/athletic pubalgia. The primary endpoint is patient being free~     from intractable groin pain during sports activity or daily work four weeks after surgery.~   "
96988|NCT02297698|"~     This will be a multi-center, prospective, randomized, single-blinded, placebo-controlled~     phase II trial of trastuzumab + nelipepimut-S/GM-CSF versus trastuzumab + GM-CSF alone. Our~     target study population is high-risk HER2-positive breast cancer patients. High-risk~     HER2-positive breast cancer patients are defined as:~      Those with HER2-positive breast cancer, regardless of hormone receptor status, who receive~     neoadjuvant therapy with an approved regimen that includes trastuzumab and at least four~     cycles (12 weeks) of taxane-containing chemotherapy, and fail to achieve a pCR.~      Those with HER2-positive breast cancer, regardless of hormone receptor status, who undergo~     surgery as a first intervention and are found to have ≥ 4 positive lymph nodes.~      Those with HER2-positive, hormone receptor negative breast cancer who undergo surgery as a~     first intervention and are found to have 1-3 positive lymph nodes.~      Disease-free subjects after standard of care multi-modality therapy will be screened and~     HLA-typed.~   "
96989|NCT02297685|"~     Objective: The aim of this investigation was compare the effectiveness of transcutaneous~     electrical nerve stimulation (TENS) and interferential currents (IC) on chronic low back~     pain. Forty-eight patients diagnosed as having chronic low back pain were randomly assigned~     to three groups: control (sham electrotherapy; age 47 ± 8 years), interferential currents~     (IC; age 48 ± 8 years) and transcutaneous electrical nerve stimulation (TENS; age 48 ± 8~     years). Patients in all groups received 12 × 30-min sessions of the assigned treatment for a~     period of 4 weeks plus therapeutic exercises. Before and after the treatment, low back pain~     was measured using a 100-mm visual analogue scale and functional disability level was~     measured using the Rolland Morris Disability Questionnaire. Participants status was followed~     up 3 months after the end of the treatment.~   "
96990|NCT02297672|"~     Permanent Breast Seed Implant (PBSI) has been demonstrated to be a well accepted and well~     tolerated form of partial breast radiotherapy. This protocol aims to build on the initial~     experience and to further refine the technique and collect toxicity and cost data, especially~     in comparison to alternate forms of breast radiotherapy.~   "
96991|NCT02297659|"~     Damage control laparotomy (DCL) has proven to be a successful means to improve survival in~     severely injured patients.1-5 However, the consequences of not being able to close the fascia~     after the initial operation due to significant resuscitation leading to bowel and~     retroperitoneal edema, abdominal compartment syndrome, and continued acidosis, coagulopathy~     and hypethermia6-7 has led to a new challenge. Delays in primary fascial closure (PFC)~     contributes to increased fluid losses and nutritional demands,8-9 abdominal wall hernias,~     enterocutaneous fistula, and intra-abdominal infections.10-13 Hypertonic saline (HTS) use~     after DCL has been suggested to reduce bowel edema and resuscitation volumes, thus allowing~     for a quicker time to closure.14 Investigators will randomize patients to receiving HTS or~     standard crystalloid solutions after DCL and compare the time to PFC, rate of successful~     closure, and rate of complications associated with an open abdomen. The current failure rate~     of PFC after DCL is approximately 25%. Investigators believe they can improve PFC rates using~     hypertonic saline.~   "
96992|NCT02297646|"~     The purpose of this study is to investigate the effects of carbohydrate intake on training~     efficacy and health parameters of an endurance training program in healthy adults.~   "
96993|NCT02297633|"~     This study through the long-term observation followed up for 2 years to find the change of~     the COPD patients blood ROMs, systematically evaluate the relationship between ROMs and the~     severity of COPD. Evaluate the differences of prognosis between the different oxidative~     stress level (according to the level of ROMs are divided into higher and normal phenotype).~     Explore the new oxidative stress evaluation index ROMs application value in COPD.~   "
96994|NCT02297620|"~     The objective of this survey is to confirm the safety of Suglat Tablets when used in the~     elderly.~   "
97383|NCT02292550|"~     This is a Phase Ib/II study of the ALK inhibitor ceritinib in combination with the CDK4/6~     inhibitor LEE011 in patients with ALK-positive non-small cell lung cancer.~      The purpose of the study is to determine the MTD/RP2D of the LEE011 and ceritinib combination~     and evaluate whether the combination is safe and has beneficial effects in ALK-positive~     advanced non-small cell lung cancer patients.~   "
96995|NCT02297607|"~     Patients undergoing an esophagectomy will be randomized to receive either (1) routine~     post-operative tube feeding for 1 month post-operative or (2) usual practice, which is tube~     feeding to continue in the hospital until the patient is taking adequate nutrition by mouth~     at POD#8, or upon discharge.~      Specific Aim 1 is to determine the occurrence of common complications and readmissions~     post-operatively between the two patient groups. The investigators hypothesize that routine~     use of tube feeding may reduce the occurrence of post-operative complications.~      Specific Aim 2 is to determine if routine dietary supplementation with enteral tube affects~     recovery and QOL after esophagectomy. The investigators hypothesize that routine~     post-operative supplementation will enhance patients recovery and QOL.~      For esophagectomy specifically, there is very limited literature evaluating the complication~     rate and QOL associated with the length of post-operative tube feeding and adequate~     nutritional requirements. Small randomized studies have not shown a benefit to routine tube~     feeding, although the numbers were very small, ranging from 12-70 per group. The~     investigators will randomize 200 patients for the purpose of this study.~   "
96996|NCT02297594|"~     The purpose of this study is to assess the safety, tolerability and PK of single and multiple~     ascending dose of AK0529 when administered orally in healthy subjects~   "
96997|NCT02297581|"~     The study will assess patients with at least one major AE related to treatment /~     hospitalization / immobilization in the Geriatric Fracture Center (GFC) group compared to the~     usual care group.~   "
96998|NCT02297568|"~     This randomized, placebo-controlled trial in Thai pregnancy is conducted. The study aims to~     determine whether vitamin D3 1,800 IU/d supplementation in lactating mother improves vitamin~     D status of breastfed infant.~   "
96999|NCT02297555|"~     Obesity and metabolic syndrome (MS) are closely interrelated leading to increased mortality,~     mainly due to cardiovascular disease. In addition, some cancers are much higher when obesity~     is associated with metabolic syndrome. Bariatric surgery allows significant and sustained~     weight loss with marked improvement of MS. Considered too invasive, surgery is proposed to a~     small proportion of patients who could theoretically benefit. The ENDOBARRIER® device~     implanted endoscopically is an innovative approach developed for management of obesity in the~     non-surgical manner with benefits for improvement in MS already reported in literature.~   "
97000|NCT02297542|"~     This 5-year proposal is a randomized study of split-virus influenza vaccine (SVV) in a~     high-dose (HD) vs. standard-dose (SD) formulation in each of five influenza seasons to define~     the key determinants of vaccine-mediated protection against influenza and how these~     immunologic mediators may be enhanced by vaccination with a newly approved high-dose~     influenza vaccine in older people~   "
97001|NCT02297529|"~     The study is a phase 3b, multicenter, open-label, single-arm study designed to provide~     expanded access of Talimogene Laherparepvec for the treatment of subjects with unresected~     stage IIIB to IVM1c melanoma. The study will also evaluate the safety and tolerability of~     Talimogene Laherparepvec.~   "
97002|NCT02297516|"~     The efficacy and safety, as well as subject satisfaction will be evaluated after single~     treatment with Azzalure/Dysport alone or Restylane/Emervel filler alone followed by repeated~     combined treatment with Azzalure/Dysport, Restylane/Emervel filler and Restylane Skinbooster.~     Subjects will be followed for up to 18 months after initial treatment.~   "
97003|NCT02297503|"~     The efficacy and safety, as well as subject satisfaction will be evaluated after single~     treatment with Azzalure alone or Restylane/Emervel filler alone followed by repeated combined~     treatment with Azzalure, Restylane/Emervel filler and Restylane Skinbooster. Subjects will be~     followed for up to 18 months after initial treatment.~   "
97004|NCT02297490|"~     The study will explore how allergy symptoms experienced during the grass pollen season~     compare to symptoms experienced in the Environmental Exposure Chamber (EEC).~      There are 2 treatments in this study. Both treatments are injected under the skin.~     Allergovit® Grasses works by helping the body's immune system get used to grass-pollen before~     the grass pollen season begins which may lead to decreased sensitivity and reduced allergy~     symptoms during the grass season. Placebo treatment does not contain grass pollen mixture,~     and is not expected to reduce allergic symptoms overtime.~   "
97005|NCT02297477|"~     This is a two-arm, randomized, open label Treatment Study evaluating the therapeutic~     efficacy, safety, tolerability and pharmacokinetics of a three-day course of~     Atovaquone-Proguanil (AP) or a three-day course of Atovaquone-Proguanil combined with 3 days~     of Artesunate (ASAP) in patients with uncomplicated Plasmodium falciparum malaria at selected~     sites in Cambodia. Atovaquone-proguanil, soon to adopted as a first line antimalarial agent~     by the National Malaria Control Program (CNM) in Cambodia in provinces with confirmed~     multidrug resistance, will be given with or without artesunate (AS) as a directly observed,~     standard three-day fixed dose combination treatment to all volunteers enrolled. The efficacy~     and safety of both drug combination as well as evidence for in vivo and in vitro resistance~     to their components will be monitored during the treatment period. All volunteers will~     receive a single dose of 15mg of primaquine as recommended by WHO with the first dose of AP~     or ASAP to block the transmission of malaria to mosquitoes. Resistance to AP and ASAP will be~     assessed by a combination of clinical, pharmacologic, and parasitological parameters~     including genomic signatures of selection during careful weekly follow-up visits for 6 weeks.~     Investigators will also be able to evaluate the effects of primaquine on the sexual stages of~     malaria (gametocytes).~   "
97006|NCT02297464|"~     Contrary to popular belief, previous studies have demonstrated beneficial effects of whole~     egg consumption in modifying biomarkers indicative of a greater risk of coronary heart~     disease (CHD), chronic inflammation, and insulin resistance. The following study is designed~     to conduct a comprehensive evaluation of consuming an egg-based breakfast compared to an~     oatmeal-based breakfast on lipid biomarkers, oxidative stress, inflammation, insulin~     sensitivity, and satiety in young, healthy men and women. The investigators hypothesize that~     the consumption of 2 eggs per day will not negatively impact plasma lipids in a young,~     healthy population.~   "
97384|NCT02292537|"~     The primary objective of this study is to examine the clinical efficacy of nusinersen (ISIS~     396443) administered intrathecally to participants with later-onset Spinal Muscular Atrophy~     (SMA). The secondary objective is to examine the safety and tolerability of nusinersen~     administered intrathecally to participants with later-onset SMA.~   "
97385|NCT02292524|"~     Prostate Biomarkers in Men Consuming Tomato Products~   "
97007|NCT02297451|"~     Background:~      Arteriovenous fistula (AVF) is a form of vascular access for haemodialysis. An AVF is~     normally created at the level of the wrist, but occasionally it is created in the elbow when~     there is no suitable vessel in the forearm. The most common type of elbow (antecubital)~     fistula (AFF) is a brachiocephalic fistula, which carries significantly higher risk of steal~     syndrome (AVF-associated hand ischaemia) than wrist fistulas. More recently, AFF using~     proximal radial or ulnar artery as inflow has been described and shown to have a lower rate~     of Steal syndrome than brachiocephalic fistula. This study aims to investigate the incidence~     of steal syndrome between AFF using brachial artery and that using the proximal radial/ulnar~     artery as inflow.~   "
97008|NCT02297438|"~     The study is designed to compare the clinical benefit following treatment with letrozole in~     combination with Palbociclib versus letrozole in combination with placebo in Asian~     postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior~     systemic anti cancer therapies for their advanced/metastatic disease.~   "
97009|NCT02297425|"~     Phase 1 - open label, multi-center, non-randomized, safety, pharmacokinetic and~     pharmacodynamics dose escalation study of PF-06459988 as a single agent in patients with~     advance EGFRm NSCLC (del 19, L858R, +/- T790M). The resulting PF-06459988 dose selected from~     the phase 1 portion will undergo a series of sub-studies to fully characterize the impact of~     food, antacid and CYP3A4 inhibitors/inducers. The PK studies are in addition to the MTD~     expansion and will be completed prior to the initiation of Phase 2. Phase 2 is an open label,~     multi-center single-arm study of PF-06459988 for the assessment of antitumor activity in~     patients with advanced EGFRm (del 19 or L858R) NSCLC with T790M.~   "
97010|NCT02297412|"~     This randomized pilot trial studies how well minocycline hydrochloride works in reducing~     chemotherapy-induced peripheral neuropathy and acute pain in patients with breast cancer~     undergoing treatment with paclitaxel. Drugs used in chemotherapy, such as paclitaxel, may~     cause damage to nerves that result in aches, pains, and tingling or numbness of fingers and~     toes. Minocycline hydrochloride may help lessen nerve damage from paclitaxel and improve the~     quality of life in breast cancer patients.~   "
97011|NCT02297399|"~     This trial will compare the tolerance to 2 different methods for colon cleansing before~     colonoscopy in diabetic patients.~   "
97012|NCT02297386|"~     The purpose of this study is to test the ability of a new PET scan radiotracer, called FDHT~     (stands for [18F] Dihydro-Testosterone), to better find and monitor prostate cancer.~     Radiotracers are a type of drug that carries small amounts of radioactivity that can be seen~     by the PET scanner. FDHT is a radiotracer that looks for a protein which is present in almost~     all prostate cancer cells. The investigators want to find out if we can find and monitor~     changes in cancer using a FDHT PET scan.~   "
97013|NCT02297373|"~     Patients with a history of blood clots are at risk of developing additional clots in the~     future. Doctors use a tool called a clinical decision rule to tell them how likely it is that~     a patient has a blood clot and if they should have further testing to look for the clot. This~     tool may cause doctors to over-diagnosis a recurrent clot because the symptoms may be left~     over from the previous clot. Correctly diagnosing a recurrent blood clot is very important~     since there are risks associated with both over-diagnosis and under-diagnosis. If a recurrent~     blood clot is missed (under-diagnosis) the patient is at risk of death from a clot in the~     lungs. If blood thinners are prescribed when they are not needed (over-diagnosis), the~     patient may have to take blood thinners for their lifetime and risk having serious bleeding.~   "
97014|NCT02297360|"~     The Viviscal Extra-Strength formulation is an oral food/dietary supplement specifically~     designed to promote hair growth for women suffering from temporary thinning hair. It does not~     contain hormones or drugs and has been marketed in Europe for over 15 years. Viviscal~     Extra-Strength is marketed as Viviscal Maximum Strength in some other territories.~      The hypothesis of this clinical research study is that the ingestion of Viviscal~     Extra-Strength over a three (3) month period will strengthen and promote the growth of~     terminal hairs in female subjects, ages 21-65 years of age with self-perceived thinning hair~     associated with poor diet, stress, hormonal influences or abnormal menstrual cycles when~     compared to using the placebo tablet.~   "
97015|NCT02297347|"~     Newborn screening and early treatment prevent the most severe manifestations of~     phenylketonuria (PKU). However, executive functioning deficits, attention deficit disorder,~     slow processing speed, and visual-motor problems commonly occur. Many adults with this~     disorder also suffer depression and anxiety. In this study the investigators will examine~     adults with PKU on sapropterin dihydrochloride (Kuvan) treatment for PKU and compare their~     results to those of subjects with PKU not on Kuvan. Using magnetic resonance imaging (MRI)~     techniques, including novel MR spectroscopy (MRS) the investigators hope to discover why this~     distinct constellation of deficits occurs in PKU. Adult subjects with PKU will undergo a~     comprehensive MRI evaluations, including a novel method of MR spectroscopy to determine brain~     phenylalanine levels. In addition, participants will receive neurological and~     neuropsychological examinations and dietary evaluation.~   "
97016|NCT02297334|"~     The aim of this study is to prove that using a CytoSorb(TM) filter in the cardiopulmonary~     circuit attenuates the inflammatory response to extracorporeal circulation in patients~     undergoing cardiac surgery. The hypothesis is that removing cytokines from patients' blood by~     the CytoSorb device significantly improves circulation and outcome in patients undergoing~     on-pump cardiac surgery.~   "
97017|NCT02297321|"~     This is a prospective study to evaluate the efficacy and safety of an accessory for laser~     tattoo removal in allowing multiple passes within a single treatment session.~   "
97018|NCT02297308|"~     This study is a retrospective, single center data collection to assess bleeding and vascular~     complications associated with TAVI when a SoloPath® Balloon Expandable TransFemoral~     Introducer is used for vascular access.~   "
97019|NCT02297295|"~     The purpose of this study is to determine whether exercise medicine in lower limb amputees~     has a impact on the three domains of the International Classification of Functioning of the~     WHO (function, activities and participation), and on quality of life.~   "
97386|NCT02292511|"~     The purpose of this study is to determine if a 6 month mind-motor intervention will help to~     improve overall brain health in adults over the age of 55 with type 2 diabetes and a~     self-reported complaint about memory or thinking skills. It is hypothesized that the~     intervention group will show improvements in their overall brain health after 6 months of~     mind-motor training compared to the control group.~   "
97020|NCT02297282|"~     Depression affects 15% of Canadians resulting in serious impact on health, ability to~     function including social, family and work related activities. Despite the several treatment~     options available for managing depression including medications, many patients do not respond~     to treatment and experience troublesome side effects. Psychotherapies are important in the~     treatment of depression and several options are currently being offered at the Mood Disorders~     Program (MDP), St. Joseph's Healthcare Hamilton. However a simple and reportedly effective~     therapy called Behavioural Activation (BA) is not currently available and existing evidence~     supporting its' effectiveness is limited to individual therapy of community based patients~     who are unlike the patients seen at the MDP who may have a more severe illness. The~     investigators are therefore planning to study the effectiveness of BA in patients with~     depression as an add on therapy to existing usual care compared to wait-list added to usual~     care. The study outcome is reduction in depressive symptoms and improvement in quality of~     life. The duration of therapy is 18 weeks and all adults with depression are eligible to~     participate.~   "
97021|NCT02297269|"~     Deep vein thrombosis (DVT) is a common complication of surgery, which could result in~     pulmonary embolism (PE). PE is a serious and potentially life-threatening syndrome. The~     purpose of this study is to investigate the impact of laparoscopic versus open surgeries on~     the incidence of postoperative DVT in patients with gastrointestinal malignancy~   "
97022|NCT02297256|"~     This study is a single-center, prospective randomized clinical study intended to compare and~     evaluate the efficacy of subjects who are treated with bone marrow aspirate concentrate~     (BMAC) and allograft to iliac crest bone grafts (ICBG) during posterior lumbar/lumbosacral~     spinal fusion.~   "
97023|NCT02297243|"~     The purpose of this study is to collect preliminary clinical data related to the safety and~     performance of the Sinopsys Lacrimal Stent.~   "
97024|NCT02297230|"~     Paclitaxel 30 mg/m2 twice/week Trastuzumab 4mg/kg, loading dose, then 2 mg/kg weekly and~     Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast,~     supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the~     primary tumor. At the end of chemo-radiation, Trastuzumab will be continued weekly until~     surgery and as per standard of care after surgery for up to 1 year total.~      **Surgery: Patients will undergo lumpectomy and axillary node dissection or modified radical~     mastectomy within two months following discontinuation of pre-operative systemic therapy,~     contingent upon recovery of skin toxicity. Pathologic response will be evaluated at the time~     of surgery. Additional tissue samples will be collected from the surgical specimen for~     assessment of tumor molecular characteristics.~      ***All patients may undergo four cycles of post-operative Standard AC (doxorubicin 60 mg/m2,~     cyclophosphamide 600 mg/m2) or four cycles of post-operative epirubicin and Cyclophosphamide~     (epirubicin 100 mg/m2, cyclophosphamide 600 mg/m2) if doxorubicin is not available Tamoxifen~     as well or any alternative antihormonal therapy may be prescribed for five years for patients~     with hormone receptor positive tumors. Herceptin (Trastuzumab) will be prescribed for a total~     of 1 year since first dose as per standard of care.~   "
97025|NCT02297217|"~     This study aims to show that the addition of carboplatin and paclitaxel chemotherapy to a~     palliative course of external beam radiation treatment improves both dysphagia relief and~     patient quality of life in patients with unresectable esophageal cancer.~   "
97026|NCT02297204|"~     The Endurance Trial is a phase IV open label clinical study to assess the need for ongoing~     intravitreal aflibercept injections after the 3-year VISTA DME (VGFT-OD-1009) end-point.~     Subjects will be treated with intravitreal aflibercept injections pro re nata (PRN) based on~     the presence of CR-DME (Clinically Relevant-Diabetic Macular Edema). In addition, subjects~     who meet re-treatment criteria will be eligible for focal laser treatment every 90 days.~   "
97027|NCT02297191|"~     The purpose of the study is to determine the effectiveness of a new approach to numbing~     (anesthetizing) nerves in the back and to measure how far the area of anesthesia extends on~     the skin of the back.~   "
97028|NCT02297178|"~     Urinary incontinences is a highly prevalent and distressing condition which has a significant~     impact on health related quality of life in millions of women worldwide. Of all women with~     incontinence, 90% will have overactive bladder symptoms (OAB), and 50% will have detrusor~     overactivity (DO) on cystometry. The overactive bladder syndrome is defined by the~     International Continence society as Urinary urgency, with or without urge incontinence,~     usually with frequency and nocturia if there is a no infection or proven pathology (Abrams~     et al 2002)~      Initial management of OAB and DO consists of conservative measures such as altering fluid~     intake, bladder retraining and drug therapy. The next step consists of interventions such as~     cystoscopy and urethral dilatation, on the basis that it will allow intrinsic bladder~     problems such as interstitial cystitis to excluded, excluded, and may confer a symptomatic~     benefit.~      The original study showed no benefit of urethral dilatation versus no dilatation at 6 months~     follow up (Duckett 2007). The investigators do not know the natural history of patients with~     voiding dysfunction. Therefore reviewing their symptoms will give a better idea of what~     happens to these patients symptoms over time.~   "
97029|NCT02297165|"~     The purpose of this study is to estimate the impact of an olfactive stimulation, in relaxing~     environment, on the access at the autobiographical memories in anorexic patients.~   "
97030|NCT02297152|"~     The aim of study is to determine if they can produce increases in the IELT using a~     masturbator in subjects with premature ejaculation, producing improvements in the quality and~     satisfaction of the sexuality of the patient.~   "
97031|NCT02297139|"~     The purpose of this study is to continue to provide dasatinib to patients that are currently~     participating in another dasatinib trial that is ending and for which there is no other~     option to provide dasatinib.~   "
97100|NCT02296229|"~     This clinical trial studies stereotactic body radiation therapy in treating patients with~     high-risk prostate cancer that has not spread to nearby lymph nodes or to other parts of the~     body. Stereotactic body radiation therapy is a specialized radiation therapy that delivers a~     single, high dose of radiation directly to the tumor and may kill more tumor cells and cause~     less damage to normal tissue. Studying quality of life in patients undergoing stereotactic~     body radiation therapy may help identify the long-term effects of treatment on patients with~     prostate cancer.~   "
97032|NCT02297126|"~     The INGenious trial will prospectively enroll a total of 6,000 patients, with 2,000 patients~     assigned to a pharmacogenetic testing arm and 4,000 to a control arm who will be followed,~     but not tested. It is randomized between an intervention arm and one that receives no~     intervention in order that the genotyped group can be compared with one in which undisturbed,~     routine clinical care is carried out in patients taking the same drugs. Both arms will be~     followed for a year after being prescribed a targeted medication. Patients randomized into~     the intervention arm that are prescribed one or more of the 24 targeted index medication will~     receive pharmacogenomic testing using a custom micro-array measuring 51 Single nucleotide~     polymorphisms in 16 genes. The study is being conducted by the Indiana University School of~     Medicine and the Indiana University Institute of Personalized Medicine in collaboration with~     the Eskenazi and Indiana University Health Systems and will evaluate the economic and~     clinical outcomes associated with embedding a pharmacogenomics program in a system that~     serves as the primary health care safety-net in Indianapolis, Indiana. By successfully~     implementing a pharmacogenomics program and integrating it with the Electronic Health Record~     and Clinical Decision Support system, physicians will be able to optimize patient care by~     delivering tailored therapeutic decisions based on the patient's individual genetics.~   "
97033|NCT02297113|"~     All patients undergoing emergent endotracheal intubation (RSI) at the Emergency Department~     will be screened for inclusion in this clinical study. The indication of endotracheal~     intubation is an exclusively clinical decision and is not affected by this study protocol in~     any aspect.~      If fulfilling the In- and exclusion criteria's, patient will be randomly assigned to one of~     two groups~        1. C-MAC Videolaryngoscope in appropriate size~        2. conventional endotracheal intubation using Macintosh Blade in appropriate size~      Randomization (1:1) will be based on computer-generated codes maintained in sequentially~     numbered opaque envelopes that will be opened immediately before randomization.~   "
97034|NCT02297100|"~     The purpose of this research study is to identify the optimal usage of Onabotulinumtoxin A in~     interstitial cystitis. Onabotulinumtoxin A, more commonly known by the trade name Botox®, is~     a medication that comes from the bacteria Clostridium botulinum. It works by blocking the~     release of the neurotransmitter acetylcholine(a chemical messenger that carries signals~     between nerve cells and other cells in the body). Blocking that neurotransmitter results in~     decreased muscle activity.~   "
97035|NCT02297087|"~     Aim 1 - Launch Pilot Study. In this aim, the investigators seek to launch a pilot study and~     enroll 12 eligible patients with advanced small cell lung cancer (SCLC) and to obtain the~     necessary tumor biopsies to yield sufficient DNA and RNA for Genome-Wide Sequencing (GWS).~      Aim 2 - Treatment Selection. Completion of this study aim will provide a new clinical~     paradigm in the treatment of SCLC such that each individual patient would be treated with a~     single-agent or combination therapy of commercially available agents that relates to~     particular target(s) that have been identified via GWS.~   "
97036|NCT02297074|"~     The present study was carried out to determine the glycaemic index (GI), glycaemic load (GL),~     insulinaemic index (InI), appetite ratings and postprandial plasma concentrations of~     gastrointestinal hormones related to the control of food intake after the ingestion of five~     types of commercially available selected Spanish breads. All volunteers took the breads and~     glucose in a crossover interventional study.~   "
97037|NCT02297061|"~     Hip fractures are associated with a large hidden blood loss. That is, the total blood loss~     associated with hip fracture surgery is much greater than that observed intra operatively.~     There is currently no viable method of identifying patients at risk of transfusion. The on~     admission haemoglobin level has been shown to be falsely reassuring .~      We are conducting a study of 200 consecutive hip fracture patients. Thrombelastography (TEG)~     is taken on admission. The results are blinded to clinicians. Results will be evaluated at~     the end of the study, comparing intra-operative and total blood losses with the TEG profile~     of the patient.~   "
97038|NCT02297048|"~     Progesterone is needed to permit adaptation of the kidney to limit potassium loss in the~     urines. The investigators wonder whether progesterone or other adrenal hormon play the same~     role. The investigators will investigate surrenal hormone production in healthy subjects~     under a 7-day potassium depleted diet and in patients chronically hypokalaemic due to a renal~     loss of potassium.~   "
97039|NCT02297035|"~     Primary progressive aphasias (PPA) represent a challenging group of degenerative language~     diseases that has led to growing interest in the scientific and medical community. However, a~     full-blown cognitive/linguistic, anatomic and biologic characterization of the three main~     variants remains incomplete given that the available data derive from relatively small~     patient samples. Such a three-fold characterisation will be an major milestone with the~     prospective of providing the rationale for therapeutic interventions comprising specific~     rehabilitations protocols and pharmacological trials.~      The present study addresses theses issues in the three PPA main variants through a~     cross-sectional and longitudinal investigation exploring 1) cognitive/linguistic features, 2)~     anatomic/metabolic specifications (MRI-VBM, MRI-fiber tracking, functional connectivity - MRI~     resting state, PET), and 3) biologic aspects (CSF biomarkers, genetic screening).~   "
97040|NCT02297022|"~     The purpose of this study is to investigate the safety and efficacy of deep brain stimulation~     in obese patients with Prader Willi syndrome refractory to conventional treatment.~   "
97041|NCT02297009|"~     A buccal swab will be taken using a cotton stick by rubbing it against the buccal mucosa.~     Samples will be taken from the same participant at different timepoints.~      DNA will be extracted from the buccal cells on the swabs using a commercial extraction kit~     and will be quantified by a nano-drop spectrophotometer.~      We will determine global and gene-specific methylation and hydroxymethylation alterations by~     UPLC/MS/MS. Hydrolyzed DNA into individual nucleosides will be analyzed for the quantitative~     measurement of 5-methylCytosine and 5-hydroxymethylCytosine on Triple Quadrupole UPLC/MS/MS~     platform. Secondly, specific methylation in the CpG islands of tumor suppressor and promoter~     genes, and genes involved in the oxidative stress pathways will be assessed by~     PCR-pyrosequencing.~   "
97115|NCT02296034|"~     The purpose of this study is to measure blood glucose variation in youth prior to and after~     participation in a healthy lifestyle intervention program. The hypothesis is that youth with~     more severe obesity and those further along in puberty will have more glycemic variability,~     and that glycemic variability will be improved by participation in the lifestyle intervention~     program.~   "
97042|NCT02296996|"~     Patients with BRAF V600 mutant advanced melanoma benefit from treatment with a BRAF-inhibitor~     (e.g. dabrafenib, vemurafenib) and from combination of a BRAF- and MEK-inhibitor (e.g.~     dabrafenib and trametinib). Following initial tumor regression, progression is diagnosed in a~     majority of patients treated with BRAF-inhibitor mono-therapy within the first 12-months of~     therapy. Various molecular mechanisms that underlie the development of resistance to~     treatment with a BRAF-inhibitor have been reported. These mechanisms do not include secondary~     mutations in the BRAF-gene and therefore resistance to BRAF-inhibition could potentially be~     reversible when selective pressure by BRAF-inhibition is withheld for a sufficient period of~     time of melanoma progression. This clinical trial protocol addresses the potential renewed~     anti-tumor activity of combined BRAF- and MEK inhibition with the combination of dabrafenib~     and trametinib in patients with unresectable AJCC stage III or - IV BRAF V600 mutant melanoma~     who are documented with progression of disease at least 12 weeks following the last day of~     dosing of a BRAFinhibitor containing treatment regimen.~   "
97043|NCT02296983|"~     Previous Ebola outbreaks have been limited to individual countries and contained by infection~     control activities. The current outbreak in West Africa is international, and air travel has~     resulted in a number of infected travellers crossing national borders. There are currently no~     specific treatments generally available for Ebola and the mortality is high, particularly in~     countries with limited intensive care facilities. There is currently no vaccine and the~     personal protection required by healthcare workers treating patients is cumbersome and~     requires full compliance to be protective.~      There is now a consortium (VEBCON collaboration) of four clinical centres (in Kenya, Gabon,~     Switzerland and Germany), WHO and New Link Genetics (the vaccine manufacturer) under which~     this study will be conducted. The investigators are conducting this trial, a Phase I,~     open-label, dose escalation trial, designed to establish safety, tolerability and~     immunogenicity of two doses of VSVΔG-ZEBOV, an Ebola Virus Vaccine Candidate for the first~     time in sub-Saharan African populations.~      The investigators plan to vaccinate 40 volunteers in Kenya. The trial will be conducted at~     the KEMRI-CGMR Coast site where healthcare workers (both clinical and laboratory) will be the~     primary target population as they are likely to be the recipients of a protective vaccine.~     The investigators will vaccinate a cohort of 20 volunteers at a low dose and then vaccinate a~     further cohort of 20 volunteers at full dose. Each volunteer will receive one dose of the~     vaccine. The investigators will follow them up for a period of one year looking to their~     safety and immunogenicity endpoints.~   "
97044|NCT02296970|"~     Determine the effectiveness of a deep shave removal as a definitive treatment for basal cell~     carcinoma (BCC) without the need for a follow up surgical procedure.~   "
97045|NCT02296957|"~     Brief Summary~      Context. Sleep disorders complaints are common in elderly and hypnosedative drugs are widely~     prescribed in community-dwelling elderly. Furthermore, acute hospitalisation may induce sleep~     disorders and hypnosedative initiation occurs in 14 to 29% of elderly during a hospital stay.~     These hospital-induced sleep disorders should spontaneously disappear after discharge and,~     because of their potential impact on falls, hip fractures, psychiatric side effects and~     induced dependence, hypnosedative drugs should therefore be discontinued at discharge in~     these naïve-treated patients. Adhesion to this recommendation is poor. Recent and on-going~     research on this topic mostly concerns adverse effects although these are already~     substantially documented and evidence-based, while there is a poor interest on developing~     research on potential strategies susceptible to practically improve the current adhesion to~     recommendations.~      Design and objectives. This project proposes multi-component intervention and is directed~     towards hospital prescribers, patients, and their general practitioner. It aims at~     discontinuing, at hospital discharge, the hypnosedative treatment that was initiated during~     hospitalization in naïve-treated elderly (age≥65) patients. The value of the intervention, as~     compared to usual care management, will be estimated in a multicentre (6 hospitals gathering~     8 centres: 5 internal medicine departments, 3 cardiology departments) randomised, cross-over,~     two-period trial. Two hospitals will gather 2 centres (2x2 centres) and 4 hospitals will~     gather only 1 centre (4x1 centres). An equilibrated randomization will be applied to the 8~     centres, making sure that, in hospitals gathering 2 centres, these 2 centres will apply the~     same strategy in a given period and that the 2 hospitals will apply alternative strategies.~     This randomisation is set up to avoid the risk of a potential contamination between the 2~     strategies from one centre to the other within the same hospital. As a result, 3 hospitals~     (including 4 medical departments) will apply the intervention during the first 11-month~     period, while the 3 others (including 4 medical departments) will apply usual care during~     this period, as a result of an equilibrated hospitals randomization. During the second~     11-month period, each hospital will apply the alternative management. The two periods will be~     separated by a 1-month wash-out period.~      In all 240 patients (15 patients / centre) will be enrolled (120 in the intervention group~     and 120 in the usual care group).~      Patient follow-up duration will be 12 months after discharge. Patient status in regards with~     quality of sleep (study primary objective), hypnosedative consumption and frequency of falls~     (secondary objectives) will be collected by telephone interviews 1, 3, 6 12 months after~     discharge.~      Expected results. The results of the study should contribute to guide research and public~     decisions to practically decrease hypnosedative prescription and consumption, and associated~     adverse events.~   "
97046|NCT02296944|"~     This study is a retrospective cohort of patients minors during the operation of cartilage~     tympanoplasty for tympanic membrane perforation~   "
97047|NCT02296931|"~     Pre-eclampsia and eclampsia cause 50,000 deaths annually. While MgSO4 is a widely accepted~     and relatively inexpensive treatment for these conditions, barriers to delivery via IV~     injection in low-resource settings pose a large obstacle to reductions in mortality. AutoSyP~     is a low-cost, low-powered automatic syringe pump that could overcome this barrier to the~     delivery of MgSO4. We propose to conduct a pilot clinical evaluation of its ability to~     deliver MgSO4 to women with pre-eclampsia or eclampsia in Malawi.~      AutoSyP will be the subject of a 2 phase pilot clinical community trial in Malawi. Prior to~     the start of the study, all nurses will receive a 4-hour training on AutoSyP use to ensure~     proper procedures are followed. Phase 1 will be an initial validation of the clinical~     performance of the device delivering only standard IV saline to 10 stable women. The study~     will continue to Phase 2 where, the device will deliver MgSO4 to up to 40 women presenting~     with symptoms of pre-eclampsia.~        1. Prior to the start of the study, all nurses will receive a 4-hour training on AutoSyP~          use.~        2. Eligible and willing participants will provide informed consent. Then, baseline~          demographic and relevant medical history information will be collected.~        3. In Phase 1, subjects will receive IV saline fluids by the Nurse. In Phase 2, the Nurse~          will provide loading dose of MgSO4 with the AutoSyP and research staff will monitor and~          record device performance and treatment specifications.~        4. Subsequent maintenance doses of saline or MgSO4 will be administered and observations~          monitored and recorded for up to 24 hours as clinically indicated.~      Others may benefit from this study in the future as AutoSyP is a new delivery system is~     needed to break down the barriers to IV delivery of MgSO4 in low-resource settings. The~     results of this study will be made available to the Ministry of Health, NHSRC, COMREC, the~     College of Medicine Library, the Department of Paediatrics, and other partners working in~     neonatal and child health. Findings will be published in academic journals and conference~     proceedings in an effort to disseminate results to potential end-users. The research findings~     of this study will be critical in the evaluation of future interventions.~   "
97048|NCT02296918|"~     To evaluate the safety and preliminary efficacy of acalabrutinib in combination with~     obinutuzumab in 4 separate cohorts of patients.~   "
97049|NCT02296905|"~     This is an open-label, single-dose study designed to assess the pharmacokinetics and safety~     of ABT-493 and/or ABT-530 in subjects with impaired hepatic function and compare them to~     those in subjects with normal hepatic function.~      Twenty-four subjects will be selected and enrolled according to the subject selection~     criteria: 6 subjects with mild stable chronic hepatic impairment (Group I), 6 subjects with~     moderate stable chronic hepatic impairment (Group II), 6 subjects with severe stable chronic~     hepatic impairment (Group III) and 6 subjects with normal hepatic function (Group IV).~   "
97051|NCT02296879|"~     Mesenchymal epithelial transition factor (c-MET) is a receptor tyrosine kinase that, when~     engaged by its ligand hepatocyte growth factor (HGF), has been implicated in various cellular~     process including development as well as oncogenesis.~      SAIT301 is a novel humanized monoclonal antibody targeting the alpha chain of extracellular~     domain of c-MET. Binding of SAIT301 to c-MET blocks HGF binding and inhibits HGF-mediated~     signaling. Furthermore, SAIT301 also induces efficient c-MET internalization from the cell~     surface and subsequent degradation, resulting in inhibition of growth of the c-MET addicted~     cancer cells.~      The sponsor decided to enroll subjects with tumors that express c-MET (by~     immunohistochemistry [IHC]) for this study, as the subjects with no c-MET expression are~     unlikely to benefit from SAIT301 treatment.~      Stage 1 of this Phase I study is designed to evaluate the safety, tolerability,~     pharmacokinetic (PK) profile, and anti-tumor activity of SAIT301 administered as a single IV~     infusion in 21 day cycles, for up to 4 cycles. Subjects without evidence of tumor progression~     after 4 cycles will be eligible to continue on SAIT301 treatment if there is no evidence of~     tumor progression for a further 4 cycles (Cycles 5 to 8). Biomarkers related to SAIT301~     and/or tumor response will also be evaluated.Stage 2 will further evaluate the safety and PK~     profile of SAIT301 in select types of cancers. Dosing frequency may be adjusted based on the~     PK profile obtained during Stage 1.~   "
97052|NCT02296866|"~     The aims of the study is to assess whether the intravenous infusion of 3 mg/kg erythromycin~     has a significant gastrokinetic effect leading to empty the stomach in less than 90 minutes~     in non-fasting patients undergoing emergency trauma surgery.~   "
97053|NCT02296853|"~     This study will evaluate the single-dose pharmacokinetics of tenofovir alafenamide (TAF) and~     it's metabolite tenofovir (TFV) along with the safety and tolerability of TAF in participants~     with normal hepatic function and severe hepatic impairment.~   "
97054|NCT02296840|"~     Adenotonsillectomy is one of the most common surgical procedures performed in the pediatric~     population in the United States. It is generally a well-tolerated procedure with~     post-operative bleeding risk ranging from 3-5% in children. Post-operative pain following~     adenotonsillectomy has significant morbidity and may result in prolonged hospital stay or~     re-admission to the hospital. Post-operative analgesia is most commonly managed with~     narcotic-containing pain medication. In recent years however, there is evidence that some~     patients may manifest increased sensitivity to narcotics, resulting in life-threatening~     respiratory compromise. Though there is a theoretical risk that nonsteroidal~     anti-inflammatory drugs (NSAIDs) increase bleeding time by disrupting platelet aggregation,~     evidence of detrimental effects (i.e. increased risk of postoperative bleeding) remains~     inconclusive for these generally well-tolerated medications. The goal of this study is to~     determine the incidence of post-operative bleeding and to determine the efficacy of NSAIDs in~     the management of post-operative pain following pediatric adenotonsillectomy, versus more~     commonly used narcotic pain medication. The study design will be an initial retrospective~     study to collect pilot data on the incidence of postoperative hemorrhage and indicators of~     adequate/inadequate pain control in children age 4 to 17 undergoing adenotonsillectomy. This~     will be followed by a prospective, randomized, single-blind controlled study in which~     orally-administered ibuprofen (test intervention) is compared to acetaminophen-hydrocodone~     (control intervention) in the postoperative period following adenotonsillectomy.~   "
97055|NCT02296814|"~     Study to verify the efficacy and tolerability of Sinusitis Hevert SL tablets compared to~     placebo in adult patients with acute, uncomplicated rhinosinusitis (inflammation of the nasal~     and paranasal sinuses).~   "
97056|NCT02296801|"~     This study will look at effects the combination of palbociclib and letrozole may have on~     estrogen receptor (ER)-positive/human epidermal growth factor receptor 2 (HER2)-negative~     breast cancer tumors which have not yet been treated. Letrozole is a type of endocrine~     therapy called an aromatase inhibitor (AI) and is standard treatment for post-menopausal~     women with ER-positive/HER2-negative breast cancer.~   "
97057|NCT02296788|"~     In the present study, we seek to elucidate the effects of aerobic exercise on fecal~     microbiota following the aforementioned no exercise control group and two doses of aerobic~     exercise training (the exercise training spans ~24 wks) in a cross-sectional sample.~   "
97058|NCT02296775|"~     This study will compare the plasma pharmacokinetic profile and the change in disease activity~     score in patients with active rheumatoid arthritis following treatment with two 1000 mg doses~     of DRL_RI or one of two sources of rituximab (Rituxan® or MabThera®). Patients will also be~     monitored for safety, B cell depletion and recovery, and for the development of immune~     responses to the administered study drugs~   "
97059|NCT02296762|"~     This study is to assess the Sirolimus Tablets 2 mg of Dr. Reddy's Laboratories Limited, India~     and Rapamune® (Sirolimus) tablets 2 mg of Wyeth Laboratories, Philadelphia in healthy,~     adult,human subjects under Fed conditions.~   "
97060|NCT02296749|"~     This study is to assess the Sirolimus Tablets 2 mg of Dr. Reddy's Laboratories Limited, India~     and Rapamune® (Sirolimus) tablets 2 mg of Wyeth Laboratories, Philadelphia in healthy,~     adult,human subjects under Fasting conditions.~   "
97061|NCT02296736|"~     Our aim is to assess the ability of scans to distinguish the organ of origin of pancreatic~     head malignant tumours and to predict the resectability based on the preoperative imaging. To~     achieve this, a retrospective review of the preoperative CT scans will be conducted for all~     patients with pancreatic head malignancy treated at the Peninsula Hepato-Pancreatico-Biliary~     (HPB) cancer unit between January 2006 till January 2014.~   "
97062|NCT02296723|"~     This study is to assess the Valganciclovir Hydrochloride Tablets 450 mg of Dr. Reddy's~     Laboratories Limited, India and Valcyte® (Valganciclovir HCl) tablets 450 mg of Genentech USA~     Inc., Group of Roche, South San Francisco in healthy, adult, human subjects under Fed~     conditions.~   "
97063|NCT02296710|"~     The investigators evaluate the changes of echocardiographic and sleep apnea parameters after~     mitral valve surgery. The patients undergo echocardiographic and sleep apnea control before~     surgery. After a period of 3-5 months, they undergo a second echocardiographic and sleep~     apnea control and the results are evaluated.~   "
97064|NCT02296697|"~     Patients admitted in the Emergency Service that have pressure ulcers will be selected by~     eligibility criteria and randomized into three groups according to the adopted therapy: wound~     dressing (CG); wound dressing + high-frequency generator group (GAF); and wound dressing +~     low-level laser therapy group (GLBP).~   "
97066|NCT02296671|"~     In this study the investigators aim to: 1) confirm the objective response rate (ORR) observed~     in the investigators initial study for patients with the TSER*2/*2 genotype 2) determine~     whether PEMOX regimen is more worthy of future development for this patient genotype selected~     population than FOLFOX based on the data indicating that pemetrexed may be a better TS~     targeted agent than 5-FU.~      Patients who are homozygous for the TSER*2 allele (TSER*2/*2) will be able to continue in the~     study and will be randomized. Patients with other TSER genotypes will not be included and~     will be considered screen fails.~      The first 8 patients with the TSER*2/*2 genotype will be randomized 1:1 to receive treatment~     with either PEMOX or FOLFOX (4 in each group).~      Analysis of the objective response rate (ORR) in each treatment arm will occur after the~     first 8 patients are enrolled. Using the proposed Bayesian design, subsequent patients will~     be preferentially assigned to the better performing treatment arm based on continuous~     real-time reassessments of ORR results.~   "
97067|NCT02296658|"~     The aim of this phase II trial was to evaluate the feasibility, efficacy and tolerability of~     intensity-modulated radiotherapy combined with S-1 based chemotherapy in patients with~     pathologically positive lymph node after completely resected gastric cancer. Furthermore, the~     investigators sought to compare the dosimetric differences between the volumetric-modulated~     arc therapy (VMAT), Tomotherapy and intensity-modulated radiotherapy (IMRT) techniques in~     treatment planning for gastric cancer as adjuvant radiotherapy.~   "
97068|NCT02296645|"~     This is a randomized, paired-comparisons design where each subject receives two of the~     planned treatments.~   "
97069|NCT02296632|"~     This study aims to provide preliminary evidence of the validity of a sensor-based assessment~     of rheumatoid arthritis (RA) symptoms, and to collect structured qualitative feedback from RA~     Enbrel patients regarding the potential of a future biosensor/PRO mHealth application. The~     investigators' overarching hypothesis is that if patients have better and more timely~     information about whether Enbrel is working, then they will become more empowered and engaged~     in their treatment, more curious about how it may - or may not - be working, and potentially~     more compliant with therapy. However, this hypothesis remains largely untested.~   "
97070|NCT02296619|"~     The purpose of this study is to determine the effects of Transversus Abdominis Plane Block on~     hemodynamic variables, anaesthetic and analgesic requirement, and quality of recovery in~     patients undergoing total abdominal hysterectomy~   "
97071|NCT02296606|"~     Prospective, observational, non-randomized study of interrater reliability of pupillary~     assessments, comparing two clinical assessments to the Pupillometer.~   "
97072|NCT02296593|"~     Continuous lactate and glucose blood levels~   "
97073|NCT02296580|"~     This feasibility study will assess the effects of the Nativis Voyager therapy in patients~     with first or second recurrence of GBM who have either failed standard of care or are~     intolerant to therapy. The study will enroll and treat up to 32 subjects with Voyager plus~     lomustine. Safety and clinical utility will be evaluated.~   "
97074|NCT02296567|"~     To demonstrate the effects of Lucentis (ranibizumab), Avastin ( bevacizumab), and Eylea (~     aflibercept) on the levels of naturally occurring Vascular Endothelial Growth Factor (VEGF)~     in the systemic circulation of Age Related Macular Degeneration patients currently treated~     with these medications.~   "
97075|NCT02296554|"~     Biceps Tenodesis is currently advocated for older, less active patients, but to date is not~     often advocated for Superior Labral Tear from Anterior to Posterior (SLAP) tears in young,~     active patients. The ideal surgical management for this pathology is not clearly known. More~     surgeons are using biceps tenodesis as a treatment for SLAP tears, including in the young,~     active population. If this study were to demonstrate that biceps tenodesis is similar to or~     better than SLAP repair, this would fundamentally change the treatment of SLAP tears. Perhaps~     more importantly, it would likely mean a less involved rehabilitation and earlier return to~     activities for patients with this pathology.~   "
97076|NCT02296541|"~     The purpose of this study is to evaluate the safety and immune response to three DNA vaccines~     and a MVA-CMDR vaccine that may boost the immune response to the DNA vaccines in healthy,~     HIV-uninfected adults.~   "
97077|NCT02296528|"~     Biomedical devices, such as artificial joints and pacemakers, are accepted and commonly used~     in medicine. While great progress in biomedical devices has been made for many other~     disorders, there is currently no device available to assist with the act of deglutition. The~     investigators have developed a biomedical device (Swallow Expansion Device, SED) that assists~     with swallowing by mechanically opening the upper esophageal sphincter and allowing food and~     liquid to safely enter the esophagus. The SED has proven safe in cadaver and live animal~     studies (Belafsky, 2010).~   "
97078|NCT02296515|"~     Reservoir fill port identification by palpation versus ultrasound,a mono-centre prospective~     comparison study in patients undergoing regular intrathecal pump refill~   "
97079|NCT02296502|"~     The study aim is to prospectively compare DSM-IV-TR and DSM-5 criteria for Autism Spectrum~     Disorder (ASD) in a sample of 250 children and adolescents who meet DSM-IV-TR criteria for~     ASD and 150 children and adolescents referred for diagnosis who do not meet DSM-IV-TR~     criteria.Families and children will be recruited from eight sites affiliated with the Autism~     Treatment Network (ATN). Participants must be between the ages of 2.0 and 17.11 years who~     undergo an ATN assessment at one of the eight sites. Both subjects who are found to meet~     criteria of ASD/PDD and those who do not meet criteria (after completing the ATN assessment)~     will be enrolled. After completing the standard ATN assessment, clinicians will complete a~     DSM-IV and DSM-5 checklist for ASD/PDD.~   "
97116|NCT02296021|"~     This study aims at evaluating efficacy and safety of berberine-containing quadruple~     therapy(berberine, esomeprazole, clarithromycin and amoxicillin) versus bismuth-containing~     quadruple therapy (bismuth,esomeprazole,clarithromycin and amoxicillin) in H. pylori~     eradication. It is hypothesized that berberine-containing quadruple therapy is non-inferior~     to bismuth-containing quadruple therapy. Patients with confirmed H. pylori positive status~     will be randomized to one of the treatments described above. At week 2 and 6 follow-up~     visits, a urea breath test(UBT) will be performed to confirm eradication.~   "
97390|NCT02292459|"~     The purpose of this study is to evaluate the complete resolution of constipation in~     participants taking PEG 3350 compared to those taking PEG 4000, based on analysis of the~     number of bowel movements from self-reported bowel movement (BM) data. The complete~     resolution of constipation is defined as the elimination of straining or of hard/lumpy~     stools.~   "
97080|NCT02296489|"~     Asthma is a common chronic disorder of the airways characterized by periods of reversible~     airflow obstruction known as asthma episodes or attacks. Asthma attacks are caused by~     chronically hyperactive (contraction of the muscles surrounding the airways) and inflamed~     airways, leading to airflow obstruction, and may be mild, moderate, or severe enough to~     become life-threatening events. Severity of asthma exacerbation is assessed through medical~     history and lung function measurements with Spirometer and requires full cooperation of the~     patient. Thus, in uncooperative populations or during emergency medical situations the~     spirometer cannot be used. As an alternative, capnography data has been proposed as an~     indicator of bronchospasm in asthma. Previous studies found correlations between the~     capnography parameters and methacholine challenge in asthma patients. However, the~     relationship between capnography parameters and severity of asthma or severity of asthma~     exacerbation have not been well characterized. The study hypothesis is that within the~     clinical population that is invited to do the methacholine challenge, a different waveform~     pattern in asthma patients will be detected and possibly a correlation between the severity~     of obstruction and pattern of waveform during the methacholine challenge. In this proposed~     feasibility observational study, sixty subjects, both men and women, who will be invited to~     participate in the methacholine challenge in the Institute of Pulmonary Medicine at Rabin~     Medical Center, will be recruited to the study. Respiratory information will be recorded~     using the CapnostreamTM20p while the subjects will wear the non-invasive Smart CapnoLine®~     Plus sampling line. Additionally, FeNO will be measured using a DENOX 88 device during the~     methacholine challenge.~   "
97081|NCT02296476|"~     A study of single-agent MK-8628 (formerly known as OTX015) in recurrent GBM after standard~     front-line therapy failure.~      The first phase of the study (dose escalation) will determine the maximum tolerated dose~     (MTD). MTD assessment will be based using dose-limiting toxicities (DLTs) observed during the~     first 28 days of treatment.~      The second phase of the study (expansion cohort) will assess efficacy as measured by the~     progression-free survival rate at 6 months (PFS-6) as determined by an independent central~     review committee.~   "
97082|NCT02296463|"~     This is a randomized, observer-blind, irrelevant comparator-controlled trial in male and~     female subjects ≥24 months of age and <72 months of age. Subjects will be without symptomatic~     chronic cardiopulmonary disease, including recurrent wheezing. Subjects will be screened for~     seropositivity to RSV in a qualified serum microneutralization (MN) assay and will be~     excluded if titers for either RSV/A or RSV/B are <1:16 (4 log2).~      Treatments will comprise an IM dose of saline placebo or RSV F vaccine on Day 0 and an IM~     dose of RSV F vaccine or a licensed hepatitis A vaccine on Day 28. Hepatitis A vaccine (and~     in one group placebo) will be used to maintain the study blind; all subjects will receive a~     complete course of hepatitis A vaccine as a study benefit.~   "
97083|NCT02296450|"~     The purpose of this study is to see how skin conditions that are related to different kinds~     of cancer or cancer treatments affect a patient's overall well-being. Skin conditions are~     common in cancer patients and survivors. Sometimes, the skin condition is directly related to~     the cancer. Other times, these conditions are a side effect of cancer treatment. Patients in~     the study will be asked to fill out at least one questionnaire about how they feel about~     their skin condition. If the patient needs to be treated for their skin condition, they will~     be asked to complete the same questionnaire when they return for a follow-up visit. The~     investigators hope the study will improve our understanding of how cancer patients feel about~     their skin conditions. They also hope this study helps them learn how to improve the way we~     treat skin conditions in cancer patients.~   "
97084|NCT02296437|"~     Among antidepressant treatments, electroconvulsive therapy (ECT) remains the most effective.~     However, patient concerns with cognitive side effects have encouraged trials of new,~     non-convulsive forms of mild brain stimulation such as transcranial Direct Current~     Stimulation (tDCS). Our past and present studies of tDCS suggest that it has antidepressant~     effects and is safe, painless and well tolerated. However, not all patients may have an~     adequate response, raising the need to find ways of optimising efficacy. This clinical pilot~     study will examine the feasibility and safety of combining tDCS with a cognitive training~     task which engages the same brain region targeted by tDCS for treatment of depression.~   "
97085|NCT02296424|"~     The purpose of this study is to evaluate the efficacy observed with canakinumab dose~     reduction in a subgroup of patients in the extension study CACZ885G2301E1.~   "
97086|NCT02296411|"~     The purpose of this study is to evaluate the superiority of the glycopyrrolate bromide (CHF~     5259 pMDI) versus placebo on top of QVAR® pMDI, in terms of lung functions parameters, as~     well as to assess its safety.~   "
97087|NCT02296398|"~     Cutaneous T-cell lymphomas (CTCL) are a heterogeneous group of neoplasm of skin-homing T~     cells that includes Mycosis Fungoid (MF), which is the most common, Sézary syndrome (SS), the~     leukemia variant of MF, and other variants of CTCL which are less prevalent. Clinical~     manifestations and prognosis are highly variable. Improving the management of this incurable~     disease with limited toxicity is the main point of the current research. Romidepsin is a~     well-tolerated histone deacetylase inhibitor which has demonstrated activity against advanced~     stages of CTCL. In November 2009, it was approved by the US Food and Drug Administration~     (FDA) for the treatment of CTCL in patients who have received at least one prior systemic~     therapy. FDA-dose approved is 14 mg/m2 days 1, 8, 15 of a 21 day-cycle. It is said that it~     should be continued as long as the patient receives benefit and tolerates the drug. We~     experienced in our clinic that a long-term (>6 months) use of Romidepsin, even with spared~     doses allows patients to maintain disease in complete remission or under control without~     severe side effects. We aim to demonstrate how many patients have benefited of this~     maintenance therapy, and detect the side effects related to the long-term use of Romidepsin,~     as well as characterize those patients that can get benefit of this therapy.~   "
97088|NCT02296385|"~     To assess the bioefficacy of omega-3 fatty acids (provided by intake of fish oil supplements)~     depending on genotype of relevant factors in lipid metabolism~   "
97283|NCT02293850|"~     This is an open labeled, multiple centers, two countries (Taiwan and Korea) non-comparative~     phase I/II trial in patients with hepatocellular carcinoma. In phase I part, a maximum of 33~     patients will be recruited in this study. By utilizing a Simon optimal two-stage design, up~     to 69 patients will be enrolled into this study, while considering the 20% drop-out rate, in~     order to target 19 response-evaluable patients for the first stage and additional 36~     response-evaluable patients for the second stage in phase II part study.~   "
97089|NCT02296372|"~     Critically ill patients are on high risk for increased serum glucose levels, leading to more~     comorbidity and higher mortality risk. In patients with severe sepsis and septic shock~     hyperglycemia is a typical finding. However the need of insulin therapy is associated with an~     increased risk of hypoglycemia. Newly developed technologies for continuous glucose~     monitoring in critically ill patients may improve glycemic control and reduce glucose~     variability. The investigators will perform continuous glucose monitoring in critically ill~     patients on ICU. Measurements will be done for a period of 72h per patient. The investigators~     aim is to evaluate accuracy feasibility and acceptance of these methods. To analyze accuracy~     sensor glucose levels will be validated due to arterial blood gas measurements with the blood~     gas analyzer. The investigators will investigate the influence of several factors like~     oedema, perspiration, BMI, body temperature, pH-value application of vasoconstrictors on~     accuracy and feasibility of the particular system. Furthermore Nursing staff will be given a~     questionnaire to identify acceptance.~   "
97090|NCT02296359|"~     Respiratory viruses are known to be risk factors for asthma (e.g respiratory syncytial~     viruses, RSVs, and Human Rhinoviruses, HRVs, may induce bronchiolitis, and wheezing illnesses~     respectively). The common flu is also known to be a risk factor and the Centers for Disease~     Control and Prevention (CDC) recommends that asthmatics receive the annual flu vaccine, as a~     high-risk group for related asthma exacerbations. The investigators will be evaluating the~     variation in individual responses over time after controlled immune activation following~     influenza vaccination of monozygotic twins, both discordant for asthma, and concordant~     non-asthmatic. The transition from initial healthy to immune-system activated physiological~     states post vaccination will provide unprecedented molecular (omics) data on the molecular~     dynamics of immune response to vaccination, and novel insight into the flu response. The~     investigators will infer novel networks and pathways and as well as the dynamics of genes and~     mechanisms involved in asthma, flu vaccination, and individual responses, and correlate them~     to evaluated personalized genetic risks in the same study. The investigators will be able to~     also contrast the vaccination response in asthmatic and non-asthmatic individuals, in a~     longitudinal approach which has never been performed before using multiple-omics that~     included an immunization response.~   "
97091|NCT02296346|"~     In this research study, the investigators will determine whether a procedure called~     Extracorporeal Photopheresis (ECP) is helpful in preventing progression of disability in~     people with SPMS when compared to monthly corticosteroid infusions. This study will determine~     whether ECP has an effect on inflammatory cells in people with SPMS and whether it has a~     beneficial therapeutic effect.~   "
97092|NCT02296333|"~     The purpose of the study is to determine whether the effect of ondansetron on the analgesic~     effect of acetaminophen. Because 5HT3 blockers prevent the analgesic effects of acetaminophen~     and also reduce opioid consumption~   "
97093|NCT02296320|"~     Clinical trial looking at safety and efficacy of MEDI4893 in prevention of pneumonia caused~     by Staphylococcus aureus in high-risk patients~   "
97094|NCT02296307|"~     This study hopes to improve early detection of ovarian cancer. It will determine if women~     with bloating, abdominal distension, abdominal/pelvic pain, increased urinary frequency~     and/or early satiety, benefit from earlier surgery after screening by CA-125 ovarian cancer~     biomarker and transvaginal ultrasound.~   "
97095|NCT02296294|"~     This volunteer study tests a recently developed whole-body bioimpedance spectroscopy device~     called Body Composition Monitor (BCM) which measures the body composition (i.e. the water~     content of the body).~      Specifically, the investigators will evaluate the use of BCM for correct detection of~     intravenous administered crystalloids in the volunteers´ fluid compartments. Furthermore we~     will test the change over time of the volunteers´ volume status after an intravenous fluid~     therapy.~   "
97096|NCT02296281|"~     The purpose of this study is to assess the safety and efficacy of pirfenidone capsules to~     treat grade 2 or above radiation-induced lung injury patients.~   "
97097|NCT02296268|"~     Stroke is a leading cause of chronic disability here in Nova Scotia and globally. Aerobic~     exercise is known to improve health by increasing energy levels, physical mobility, balance,~     bone health, cardiovascular risk reduction, mental well-being, cognition, sleep, and quality~     of life. Nonetheless, people remain woefully inactive after stroke, regardless if they are in~     hospital or at home. The current investigative team and others have shown that even during~     physiotherapy, exercise intensity is not adequate to increase physical fitness. Consequently,~     patients are often deprived of a treatment that could improve their recovery. Why does this~     gap between evidence and clinical practice persist? Through a national survey the current~     team found that an important contributing factor is lack of appropriate screening (especially~     stress tests) to ensure that patients are safe to engage in aerobic exercise. This project is~     designed to close this evidence-practice gap by establishing a state-of-the-art aerobic~     exercise screening and prescription clinic at the Nova Scotia Rehabilitation Centre (NSRC).~     The intent is to compare outcomes of stroke rehabilitation participants before and after the~     clinic is underway and determine if the clinic has a positive effect on the confidence of~     NSRC physiotherapists to use aerobic exercise safely and effectively in stroke~     rehabilitation.~   "
97098|NCT02296255|"~     The purposes of this study are to evaluate the effectiveness of vaccination in 25-year old~     women at the time of their first access to cervical cancer screening, to understand the~     impact of vaccination on screening activity; to evaluate the immune response following~     vaccination; to study the dynamics of the infection after vaccination, including the possible~     change in the frequency of non-vaccine HPV types, to evaluate cytological abnormalities~     reductions in vaccinated women and to assess if HPV test in urine sample could be a useful~     non-invasive method to monitor HPV status in younger women.~   "
97099|NCT02296242|"~     This study is being performed to assess the safety, tolerability, and preliminary clinical~     effects of BVD-523 given orally, twice daily for 21-day cycles, in patients with Acute~     Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS).~   "
97331|NCT02293226|"~     The investigators will compare the success rates and time to successful intubation of~     endotracheal intubation during simulated pediatric and infant resuscitation with and without~     chest compression using four different video-laryngoscopes.~   "
97101|NCT02296216|"~     Transsphenoidal surgery is the first-line treatment of acromegaly. Adjunctive radiotherapy~     can be necessary when surgery is ineffective to avoid a prolonged medical treatment. Several~     studies reported long-term extra-pituitary side-effects of conventional radiotherapy.~     However, none has evaluated potential side-effects induced by Gamma Knife radiosurgery, a~     highly precise stereotactic technique, that has been used as an effective treatment of~     acromegaly.~      Aims of the study: To determine potential long-term (superior to 10 years) extra-pituitary~     side-effects of Gamma Knife radiosurgery in patients treated for Acromegaly.~      Methods: Transversal exposed/unexposed study. Exposed patients have been treated by Gamma~     Knife Radiosurgery after unsuccessful surgery 10-20 years before inclusion, whereas unexposed~     patients have been treated by somatostatin analogs after unsuccessful surgery for at least 10~     years before inclusion. 80 Patients (40 patients/group) will be evaluated in terms of~     cognitive dysfunction, quality of life, secondary tumor, stroke, pituitary deficits and~     growth hormone control of hypersecretion. Recruitment is planned to last for 2 years.~      Expected results: We should be able to determine whether Gamma Knife radiosurgery is a~     long-term safe technique. This result might modify the management and follow-up of patients~     with acromegaly unsuccessfully treated by surgery.~   "
97102|NCT02296203|"~     This is a multicentric, phase II single-arm study in which KRAS, NRAS and BRAF wild-type,~     irinotecan-resistant metastatic colorectal cancer patients progressing after an initial~     response to a first-line cetuximab-containing therapy, receive a rechallenge third-line~     treatment with cetuximab plus irinotecan.~   "
97103|NCT02296190|"~     The primary objective of this study is to demonstrate the superiority of at least 1 dose of~     intranasal (IN) MSP-2017 (Etripamil) over placebo in terminating PSVT induced in an~     electrophysiology (EP) laboratory.~   "
97104|NCT02296177|"~     Breast cancer is the most common cancer and the second leading cause of cancer related death~     in American women. Regular screening, early diagnosis, and timely treatment initiation have~     been shown to reduce breast cancer morbidity and mortality. However, disparities continue to~     exist across the breast cancer continuum for underserved women, particularly minority women.~     The reduction of disparities in breast cancer outcomes is a major goal of Healthy People 2020~     and the National Cancer Institute. However, the preventable burden of late stage breast~     cancer will continue until the investigators close the gap between what is known about~     prevention and what is implemented in the community. Although many sources of information~     exist about theory and [theory-] and evidence-based interventions (EBIs) to promote~     mammography screening, their adoption and use in the community has been limited and haphazard~     at best.~   "
97105|NCT02296164|"~     The Valchlor PROVe study is a multi-center, prospective, observational, US-based drug study~     that longitudinally follows patients with MF-CTCL who are receiving therapy with Valchlor.~     Patients will be followed prospectively for a maximum of 2 years from the date of signed~     informed consent (enrollment) until end of study. Continuation in the study is not contingent~     on continuation of Valchlor.~   "
97106|NCT02296151|"~     The primary objective of this study is to determine if a more specific exercise routine that~     incorporates a progressive hip stability program will help to rehabilitate the hip and reduce~     symptoms of iliotibial band syndrome more than conventional hip exercises. Three different~     exercises interventions will be compared to determine its effectiveness in reducing pain,~     improving function and returning subjects to running symptom free. Secondary objective for~     this study is to establish an intervention program for female runners with this injury. There~     will be three treatment arms and participants will be randomly assigned to one of three~     groups: Group A- control (stretching), group B (conventional hip exercises and group C~     (experimental treatment- specific progressive hip exercises).~   "
97107|NCT02296138|"~     The overall objective is to assess the effect of once daily tiotropium + olodaterol fixed~     dose combination compared to 5 µg tiotropium (both delivered with the Respimat® inhaler) on~     moderate to severe COPD exacerbation in patients with severe to very severe COPD.~   "
97108|NCT02296125|"~     To assess the efficacy and safety of AZD9291 versus a standard of care epidermal growth~     factor receptor tyrosine kinase inhibitor in patients with locally advanced or Metastatic Non~     Small Cell Lung Cancer~   "
97109|NCT02296112|"~     This phase II trial studies trametinib in treating patients with melanoma with v-Raf murine~     sarcoma viral oncogene homolog B (BRAF) non-V600 mutations that has spread to other places in~     the body. Trametinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~   "
97110|NCT02296099|"~     The purpose of the study is to determine if the administration of liposomal bupivacaine at~     the completion of a suburethral sling procedure will result in decreased postoperative pain~     compared to no injection.~   "
97111|NCT02296086|"~     The study will assess the difference in functionality between early vs. standard mobilization~     after hip fracture in the Chinese population.~   "
97112|NCT02296073|"~     To observe the efficacy and safety of dexmedetomidine sedation on the patients admitted to~     the pediatric intensive care unit after surgery.~   "
97113|NCT02296060|"~     To evaluate the exercise tolerance during pregnancy and after thanks the 6MWT~   "
97114|NCT02296047|"~     Chronic Obstructive Pulmonary Disease (COPD) is a major cause of chronic morbidity, mortality~     and disability throughout the world, leading to a heavy social and economic~     burden.Bronchodilators, the most commonly used drugs in COPD patients, have been shown to~     reduce dyspnea, improve exercise tolerance and improve health status. However,conventional~     lung function parameters such as forced vital capacity (FVC) and forced expiratory volume in~     one second (FEV1) frequently fail to detect significant functional responses to~     bronchodilators in patients with chronic airflow obstruction. It is necessary for clinical~     and scientific reasons to develop a new tool to objectively assess the effect of different~     treatments including bronchodilator on COPD. Our previous study showed that Ventilation-drive~     coupling may be more sensitive and accurate to evaluate the efficacy of inhaled~     bronchodilators in patients with COPD because it could better reflect the pathological and~     physiological characteristics of COPD.~      Based on the above conclusion, the present study were performed using the experimental~     methods of placebo and self-controlled. We aimd to explore the value of ventilation-drive~     coupling in evaluating the efficacy of bronchodilators on COPD and provide a reasonable basis~     for the clinical application of this index.~   "
97117|NCT02296008|"~     3D high resolution anorectal manometry (3DHRAM) is the most precise tool to assess function~     and 3D topographic picture of pressures along the anal canal.~      Until now, it has been used only in adult population to evaluate defecatory disorders.~      Congenital anorectal disorders are severe conditions and may present wide spectrum of~     symptoms from gastrointestinal tract.~      The usefulness of the 3DHRAM hasn't been evaluated in children after surgery for anorectal~     disorders such as Hirschsprung's disease and anorectal malformations.~      It may help for better understanding of pathophysiology of anorectal area and allow for~     planning improved procedures in these patients.~      Moreover, the investigators study may elucidate the real usefulness of the procedure in~     management of disorders of gastrointestinal tract in pediatric population.~   "
97118|NCT02295995|"~     The purpose of this study is to examine whether posttraumatic stress disorder (PTSD) symptoms~     impact adherence to a 12-week physical activity program and whether exercise can help improve~     PTSD symptoms and health outcomes in older Veterans. Approximately 50 Veterans over the age~     of 60 with PTSD will be recruited to participate in a 12-week physical activity program~     consisting of aerobic and strengthening activities. Participants will be randomized to an~     intervention arm or usual care wait-list control.~   "
97119|NCT02295982|"~     The purpose of this study is to describe the postoperative outcomes after laparoscopic~     transperitoneal nephrectomy and compare them with hand assisted laparoscopic nephrectomy with~     a focus on the limiting factors that prevent an ambulatory nephrectomy, and the benefit of~     our experiences from the previous study to optimize the postoperative outcomes.~   "
97120|NCT02295969|"~     Safety and tolerability of ORALAIR in children 5 to 9 years of age during the first 30 days~     of treatment.~   "
97121|NCT02295956|"~     The goal of this research study is to learn if it is possible to start a home-based exercise~     and nutrition program for patients with pancreatic cancer or who may have pancreatic cancer~     before surgery (pre-operative rehabilitation, also known as prehabilitation).~   "
97122|NCT02295943|"~     The macular hole formation takes place in the centre of the retina. A closure of the macular~     hole is believed to take place if the central retinal area is kept dry in the postoperative~     period. Therefore the eye is filled with a gas mix and the patients are urged to avoid the~     supine position in the first postoperative days. The investigators have developed a~     positioning measuring device which can measure the extent of supine positioning time.~     Patients are to carry the positioning measuring device during the first postoperative 24~     hours. Hereby the investigators search new knowledge concerning patients compliance and its~     relation to macular hole closure.~   "
97123|NCT02295930|"~     This is a phase II randomized study of 4-months induction first-line chemotherapy with~     FOLFOXIRI + cetuximab followed by maintenance with cetuximab or bevacizumab in patients~     affected by KRAS wild type (wt) mCRC.~   "
97124|NCT02295917|"~     The investigators aim to evaluate the width of the endometrial myometrial zone in~     participants during natural menstrual cycle by using specific computerized application on 3~     dimensions sonographic images of their uteri.~   "
97125|NCT02295904|"~     Video documentation of vaginal deliveries to evaluate the impact of the support of the~     perineum~   "
97126|NCT02295891|"~     Primary hyperhidrosis is a pathological condition characterized by the idiopathic and~     excessive secretion of sweat beyond normal physiological demand and is localized at~     particular foci such as the face, axilla, palms of the hands, and soles of the feet. Patients~     seeking medical attention for hyperhidrosis often report disruptions to their professional~     and/or social lives due to sweating and subsequently experience many psychosocial~     difficulties, such as anxiety, social phobia, and depression. Therefore, a psychiatric~     explanation of causality is frequently offered for these patients during diagnosis. Excessive~     sweating is often mistakenly interpreted as a symptom of an anxiety disorder and can be cause~     for social embarrassment, exacerbating emotional stress and social avoidance. As currently~     constituted, the treatment of secondary psychosocial symptoms in primary hyperhidrosis is~     poorly understood and requires further investigation.~   "
97127|NCT02295878|"~     Cardiovascular disease (CVD) is currently the leading cause of death worldwide. Epidemiologic~     studies have shown a diet rich in plant food protects against chronic degenerative diseases~     especially cardiovascular disease. Many of these studies have highlighted a potential role~     for phenolic compounds, which are abundant secondary plant metabolites, and which provide~     antioxidant and anti-inflammatory properties and are increasingly being shown to have an~     important role in influencing critical cell signalling pathways. A less well known, but~     nevertheless rich source of polyphenolic compounds is seaweed. In Ascophyllum nodosum, a~     common brown alga in the British Isles, polyphenols have been reported to comprise up to 14%~     of the dry weight of the plant. Some studies suggest that the potential antioxidant and~     anti-inflammatory benefits of seaweed-derived polyphenols may yield highly bioactive~     components with commercial potential for food and pharma applications. Preliminary work in~     our laboratory has revealed potent antioxidant activity of Ascophyllum nodosum extracts.~      Therefore, the aim of this randomised, double-blind, placebo controlled, crossover design~     study is to investigate the biological activity of a food grade seaweed polyphenol extract in~     terms of reducing oxidative damage to DNA, modulation of inflammatory responses and reduction~     on chronic, low level inflammation in vivo. Apparently healthy volunteers (aged 30-65 years)~     will be randomised to receive either a capsule containing 100mg seaweed extract or a matched~     placebo daily for an 8 week period, with an 8 week washout period between each treatment.~     Fasting blood and urine samples will be taken from each volunteer at 4 time-points during the~     study, at baseline and completion of the 2 treatment phases.~   "
97128|NCT02295865|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of~     JNJ-38518168 in participants with moderate to severe plaque-type psoriasis (common~     genetically determined, chronic, inflammatory skin disease characterized by rounded~     erythematous, dry, scaling patches).~   "
97153|NCT02295540|"~     This phase I/II trial studies how well hypofractionated radiation therapy followed by surgery~     works in treating patients with squamous cell carcinoma of the oral cavity that has spread to~     other places in the body. Hypofractionated radiation therapy delivers higher doses of~     radiation therapy over a shorter period of time and may kill more tumor cells and have fewer~     side effects. Giving hypofractionated radiation therapy before surgery may shrink the tumor~     making it easier to be removed, may reduce the risk of the cancer coming back, and may be a~     better treatment for squamous cell carcinoma of the oral cavity.~   "
97129|NCT02295852|"~     Mediterranean diet is relatively poor in calcium (about 700 mg/daily) whilst there are~     several reports indicating beneficial effects of calcium-rich diets. Aim of the preset study~     is to evaluate the effects of a low-sodium, low-lipid diet enriched in calcium, mainly from~     vegetables instead of dairy products, on blood pressure, body weight a main parameters of the~     glucose and lipid metabolisms.~      This study is a randomized, parallel group trial that will be performed in the Outpatient~     Clinic. At least 150 patients with arterial hypertension and/or increased body weight (IMC>~     28 kg/m2) will enter the study program. After a 3 month low-lipid low-salt diet that will be~     prescribed to all patients, they will be divided in two groups. The first will change the~     diet to that similar for total calories, percent composition of macronutrients and salt but~     enriched in calcium (about 1200 mg/daily) whilst the alternative group will continue the~     first diet. The observation period will be of 1 year with anthropometric (body weight and~     height, waist circumference), hemodynamic (blood pressure and heart rate) and metabolic~     (cholesterol, triglycerides, fasting blood glucose, uric acid, calcium, phosphorus, sodium~     and potassium) controls after 3-6 and 12 months.~   "
97130|NCT02295839|"~     This pilot randomized controlled trial examined the feasibility, acceptability and~     effectiveness of an intervention to improve sleep quality and decrease fatigue levels in~     children with a diagnosis of ALL, during maintenance treatment. Families were randomized to~     usual care or the intervention. The intervention included a sleep hygiene and relaxation~     education session with a nurse practitioner, literature for home, two story books, and a~     follow-up phone call. Self-reported measures were used in addition to actigraphy to measure~     children's quality and quantity of sleep.~   "
97131|NCT02295826|"~     Rationale: To date, anticoagulant therapy in acute stroke has also been limited by excess~     hemorrhagic events. The oral anticoagulant dabigatran is a novel agent, which has been shown~     to be associated with much lower intracranial hemorrhage rates. It has been suggested that~     this agent may provide the superior benefits of anticoagulation in acute stroke, without the~     concomitant increase in hemorrhage risk associated with heparin/LMWH or warfarin.~      Study Design: DATAS II is a randomized, open label blinded endpoint trial. Participants~     (n=300) with TIA or ischemic stroke (NIHSS score <9) will be enrolled within 48 hours of~     symptom onset from approximately four (4) health care centres across Canada. All participants~     will have an MRI with DWI lesion volume < 25 ml. Participants will be randomized 1:1 to~     treatment with dabigatran for 30 days or ASA 81 mg daily (current standard of care). All~     stroke patients will initially be screened with a non-contrast CT scan of the brain. The~     first MRI will be performed within 48 hours of symptom onset. Imaging studies will be~     repeated at day 30. All patients will be assessed clinically at Day 30 and Day 90.~      Study Aims:~        1. Establish the safety of early anticoagulation with the novel oral anticoagulant~          dabigatran in acute cerebrovascular syndrome patients.~        2. Identify the rate of both symptomatic and asymptomatic hemorrhagic transformation (HT)~          associated with these treatments.~        3. Identify predictors of HT associated with acute dabigatran treatment.~      Hypothesis: The Investigators hypothesize that symptomatic HT rates in dabigatran and ASA~     treated patients will not be significantly different.~      Study outcomes: The primary outcome is the rate of symptomatic hemorrhagic transformation~     (HT), defined as a parenchymal hematoma, which is >30% of the infarcted area on DWI, with~     substantial space- occupying effect, associated with clinical worsening (≥4 point increase in~     National Institutes of Health Stroke Scale (NIHSS) score) within 5 weeks of treatment~     initiation. The major secondary outcome the rate of asymtomatic HT see on day 30 MRI~     sequence.~   "
97132|NCT02295813|"~     The purpose of this study is to assess the clinical and laboratory safety and to determine~     the pharmacokinetic profile of FBF001.~   "
97133|NCT02295800|"~     The study design includes an observational prospective cohort of HIV-positive~     pregnant/postpartum women and their infants enrolled during antenatal clinics (or immediately~     postpartum) from prevention of mother-to-child transmission (PMTCT) programs and followed~     until the infants reach the age of 18 - 24 months and semi-structure interviews with a~     sub-set of these women. A second study component involves semi-structured interviews with~     health care workers (HCW) involved in the PMTCT programs and yearly facility surveys at the~     selected study facilities.~   "
97134|NCT02295787|"~     The investigators of this study plan to investigate the feasibility and efficacy of repeated~     doses of intranasal ketamine in severely depressed patients who are at least 65 years of age~     and experiencing suicidal ideation. The results of the study could lead to development of new~     strategies for treating depression.~   "
97135|NCT02295774|"~     Single Centre, open label assignment phase II clinical study.~      To evaluate the effect of oral 200mg Methylene Blue tablets (administered 8x25mg) prior to~     endoscopy on double stranded DNA breaks in colonic biopsy samples assessed by histone gamma~     H2AX analysis, compared to control biopsies.~   "
97136|NCT02295761|"~     Objectives: Aim of this study is to evaluate the effectiveness of Facebook-delivered~     lifestyle counseling intervention on overweight and obese adolescent's physical activity, BMI~     and adherence to healthy lifestyles.~      Design: A 12-week, randomized controlled trial with three, 24 and 36 month follow-up.~      Settings: One of the Northern Finland healthcare districts school health care units.~      Participants: all overweight or obese 13-16 years old adolescent and their parents were~     invited to study.~      Methods: Adolescents were stratified by gender, age, and self-reported physical activity and~     they were randomized into three groups. Two experimental groups, where those both got~     Facebook-delivered lifestyle counseling and one of the experimental groups got activity~     monitor which showed the daily activity. One group served as a control group. Parents were~     allocated to intervention groups according which group their adolescent were randomized.~      Outcomes: physical activity,body mass index (BMI) adherence to healthy lifestyles. Baseline~     measurements have been done and assessment to adherence to healthy lifestyles have been~     measured. Follow-up measures have been conducted three months after baseline. Adherence to~     healthy lifestyles measurement follow-up is at 24 and 36 months after intervention.~   "
97137|NCT02295748|"~     This is an open label, long-term extension study in approximately 24 male DMD subjects~     consisting of children (ages 4-12, inclusive) and adolescents (ages 13-16, inclusive) who~     participated in the MP-104-CL-005 PK study.~   "
97138|NCT02295735|"~     The aim of this randomized controlled trial is to test the efficacy of preventive dressings~     for pressure ulcer prevention.~   "
97139|NCT02295722|"~     Objective of study: To evaluate the safety and efficacy of infusional gemcitabine prior to~     HDM (high-dose melphalan) as HDCT (High Dose Chemotherapy) followed by autologous stem cell~     transplantation in patients with relapsed/refractory lymphoma.~   "
97208|NCT02294825|"~     All women managed for endometriosis are included and followed up through the CIRENDO~     database.~      Information is obtained from surgical and histological records and from self-questionnaires~     completed before surgery. Standardized gastrointestinal questionnaires (KESS, GIQLI, WEXNER,~     FIQL and Bristol) are routinely used to assess bowel function. Data recording, patient~     contact and follow-up are carried out by a clinical research technician. Postoperative~     follow-up is based on data from the afore-mentioned questionnaires completed at 1, 3, 5 and 7~     years.~   "
97140|NCT02295709|"~     Cervical transforaminal epidural steroid injections (TFESI) are indicated in cervical~     radicular pain resistant to conservation therapy, by which steroids can be delivered into~     anterior epidural space surrounding target spinal nerve roots to help alleviate pain in the~     upper limb or neck. Cervical TFESI is traditionally commended to perform with guidance of~     fluoroscopy or CT. As fluoroscopy can not monitor the injection route whether it pass vessel~     or not, many serious neurological complications caused by inadvertent intra-arterial~     injection have been reported2. Here, the investigators will introduce a novel cervical TFESI~     guided by ultrasound, which incidence of inadvertent vessel injury or injection might be~     lower than those guided by fluoroscopy.~   "
97141|NCT02295696|"~     EMMA: Empowerment, Motivation and Medical Adherence. A consultation program based on dialogue~     tools for adults with poorly regulated Type 2 diabetes.~   "
97142|NCT02295683|"~     The purpose of this study is to document safety and efficacy of renal sympathetic denervation~     treatment in subjects with uncontrolled hypertension by using Iberis renal denervation~     system.~   "
97143|NCT02295670|"~     Endotracheal intubation (ETI) is perceived as the optimal method of providing and maintaining~     a clear and secure airway. The 2010 European Resuscitation Council (ERC) guidelines~     emphasized the importance of minimal interruption during cardiopulmonary resuscitation (CPR).~     These guidelines also suggest that skilled operators should be able to secure the airway~     without interrupting chest compression. The aim of the study was to compare time and success~     rates of the Vividtrac video-laryngoscope and the Miller laryngoscope for emergency~     intubation during simulated pediatric CPR.~   "
97144|NCT02295657|"~     The aim of this study was to compare time, success rates of different double-lumen tubes in~     intubation in a standardized manikin model.~   "
97145|NCT02295644|"~     Introduction. Temporomandibular disorders (TMD) are a group of conditions that are~     multifactorial in nature, and it primarily presents with symptoms of pain and decreased~     functional capacity. Therapeutic ultrasound is a method of physical therapy that has shown~     clinically to provide immediate relief of pain in patients with different musculoskeletal~     disorders. In this study, for the purpose of immediate management of painful masticatory~     muscle and tissues, the investigators attempt to understand the mechanism of therapeutic~     ultrasound by exploring the physiologic changes peripherally and centrally. In addition, the~     investigators aim to determine if there is a dose response relationship between two different~     intensities (0.4 W/cm2 and 0.8 W/cm2) and between two sets of duty cycles (50% and 100%). A~     third purpose is to determine if therapeutic ultrasound applied to the masseter muscle is~     capable of eliciting segmental effects in the temporalis muscle. Methods. A total of 28 adult~     females with bilateral myalgia according to Diagnostic criteria for TMD (DC/TMD) will be~     recruited for this investigational trial. Each subject will be randomly allocated to one of~     the four ultrasound intervention groups each of which has different settings. Using~     Sonicator®740, therapeutic ultrasound intervention will be performed on both masseters for~     five minutes on each side of the face. A template will be used to confine the borders of the~     muscle and to determine the sites for the repeated outcome measures. Outcome parameters of:~     self-reported pain scale, pressure pain threshold, electromyographic muscle amplitudes and~     intraoral muscle temperatures will be measured for masseter and temporalis muscles on each~     side of the face, and will be assessed at baseline and after intervention on each side.~   "
97146|NCT02295631|"~     The aim of this study was to compare time, success rates of different tracheal tubes~     (standard tube and ETView VivaSight SL) for intubation with an immobilized cervical spine in~     a standardized manikin model.~   "
97147|NCT02295618|"~     The objective of this study is to compared effectiveness of intubation using ETView VivaSight~     SL and standard tracheal tube during resuscitation performed by a novice-physicians.~   "
97148|NCT02295605|"~     Forty six patients with knee osteoarthritis will be randomly allocated into two groups:~     water-based exercises and land-based exercises. Both of them will receive a strengthening~     exercise protocol for lower limb muscles. A blind investigator will assess the patients~     before and immediately after, 3 months and 6 months following the interventions. The main~     outcomes will be pain, function and strength.~   "
97149|NCT02295592|"~     TSTstarr+ in the treatment of severe hemorrhoids prolapse--A multi center randomized~     controlled clinical trial.The aim of this stuy is to compare the first year hemorrhoids~     recurrence rate of TSTstarr+ and PPH in the treatment of severe hemorrhoids.~   "
97150|NCT02295579|"~     From the earlier studies the investigators have treated women with bacterial vaginosis and~     cronic vulvovaginal candida. The investigators have then treated them with laktobacilli 10~     days for 2 month. The investigators will continue to follow them and investigate if treatment~     with lactobacilli every week for 6 month will increase cure rate.~   "
97151|NCT02295566|"~     The lungs of most patients with cystic fibrosis (CF) become chronically infected with~     bacteria called Pseudomonas aeruginosa during childhood. This infection is now known to~     consist of free-living bacteria (known as planktonic bacteria) and bacteria in colonies on~     body surfaces known as biofilms. The bacteria in biofilms are more resistant and tolerant~     to antibiotics. Current CF treatment of exacerbations aims to eradicate or control~     pseudomonal infection using aggressive antibiotic regimes.~      Despite this treatment many patients develop chronic infection which is never cleared.~     Chronic infection causes damage to the lungs. Patients colonised with Pseudomonas are more~     unwell and die at a younger age. Our laboratory has established that low dose nitric oxide~     (NO) can disrupt pseudomonal biofilms in the laboratory. This pilot study will discover~     whether non-toxic levels of NO administered to participants during an episode of acute~     infection (exacerbation) will disrupt bacteria from biofilms and increase the effectiveness~     of antibiotic therapy. This protocol describes a participant-blind randomised controlled~     pilot study of treatment with nitric oxide gas during an acute infective exacerbation (also~     known simply as an acute exacerbation). Patients with CF aged 12 or above will be asked to~     take part.~      They will be randomised to receive 7 days either of inhaled nitric oxide gas or placebo~     alongside standard therapy during an exacerbation. Sputum samples will be obtained before,~     during and after the treatment period for microbiological analysis. The primary endpoint will~     be the microbiological effect on bacterial biofilms before and after NO adjunctive therapy.~     Secondary microbiological endpoints will include the between group differences in pseudomonal~     colony forming units (CFU‟s), biofilm NO levels and detailed characterisation of biofilms~     before and after treatment.~      Secondary clinical endpoints will include lung function and well-established indicators~     quality of life. The aim of this randomised pilot study is as proof of concept and to guide~     the design of a large multi-centre trial to definitively evaluate the effectiveness of NO or~     NO donors as adjunctive therapy in CF.~   "
97152|NCT02295553|"~     The purpose of this study is to examine the dose-response relationship of ketamine in~     combination with propofol.~   "
97391|NCT02292446|"~     The purpose of this open-label, single arm, multi-center Expanded Treatment Protocol (ETP) is~     to provide early access to ruxolitinib and evaluate safety information in patients with PV,~     who are HU resistant or intolerant and who have no other standard treatment option, nor do~     they qualify for another clinical study for PV.~   "
97154|NCT02295527|"~     Hip fractures resulting from falls increase substantially with advancing age and less than a~     half of the elderly that have sustained and survived after the surgery regain their former~     levels of mobility. There is increasing evidence that rehabilitation interventions involving~     exercises and extended beyond the sub acute phase or even in a later stage of care have a~     positive impact on various functional abilities. The purpose of this study is to determine if~     an exercise program training for people who have suffered a fall-related hip fracture will~     improve functional mobility when compared with usual care. Randomized controlled trial using~     blinded assessors and intention-to-treat analysis. We will recruit 82 older adults, 60 years~     or over who have suffered a hip fracture due to a fall and have or have not completed~     physiotherapy and/or rehabilitation. These participants will be in a later stage~     rehabilitation phase (6 months up to 2 years after the fracture). Participants randomized to~     the Intervention Group (IG) will be submitted to a physical exercise program involving a~     progressive and challenging balance training and a neuromuscular and functional training of~     the lower limbs, conducted at home by physiotherapists, once a week, lasting about one hour,~     in the first, second and third month after randomization and will be oriented to perform~     exercises, twice a week, through a booklet. Visits to follow up exercises progression will be~     conducted once a month, from de fourth to the sixth month and each two months until the end~     of the follow up at the 12th month, summing up 18 sessions. Participants will receive monthly~     phone calls to increase exercise adherence. The control group will receive usual care. The~     primary outcome will be mobility-related disability and participants will be assessed in the~     baseline, at the end of the intervention (3 months), at 6 and 12 months. The participants~     will receive monthly phone calls to investigate falls and exercise adherence. Adverse effects~     will be monitored.~   "
97155|NCT02295514|"~     Despite major advances in the treatment and understanding of the pathophysiological~     mechanisms, mortality of severe sepsis remains high, ranging from 25 to 50%. With a~     prevalence > 20% in intensive care units, it is now in a population increasingly aging with~     many co-morbidities, a real public health problem. Thus, changes in treatment to~     physiological axes could change the prognosis of these patients. Protein Tyrosine Phosphatase~     1B (PTP1B) is involved in the negative regulation of many cellular pathways such as the~     response to insulin, leptin and certain growth factors and endothelial nitric oxide~     production. PTP1B appears to be particularly involved in the control of endothelial function~     and insulin secretion. Under these conditions, encouraging results have been obtained in a~     model of insulin resistance (obesity, diabetes) and as part of pro-angiogenic therapy by~     inhibition of PTP1B on models of heart failure. Recent advances have broadened the~     pathophysiological implications of PTP1B conferring a potential role in the regulation of~     inflammatory processes. In an experimental model of septic shock (Inserm 1096), the~     investigators demonstrated a significant improvement in survival and cardiovascular function~     in genetically deficient mice PTP1B (PTP1B - / -). Finally, PTP1B is involved in the~     downregulation of the signaling pathway of insulin via a feedback phenomenon. Septic shock~     induces many changes in carbohydrate metabolism. These changes result in hyperglycemia~     associated with insulin resistance, an independent risk factor of morbidity and mortality.~     Taken together, these data suggest that the expression of PTP1B could be useful in septic~     patients by modulating insulin resistance and thus the prognosis of these patients. This~     justifies the investigator clinical research project on the relationship between the~     expression of PTP1B levels, glycemic status and prognosis evaluated by the SOFA score in~     patients with septic shock with multiple organ failure.~   "
97156|NCT02295501|"~     The objective of this Phase 1 safety study is to provide access to the potential therapeutic~     benefit of EBOV convalescent plasma containing antibodies to EBOV. The risk of exposure to~     plasma from donors who may be infected with other transfusion-transmitted pathogens, not~     detectable by current licensed donor testing procedures, will be mitigated by using pathogen~     inactivation to minimize the risk of the TTI from these donors, who would otherwise be~     deferred and ineligible for blood donation.~   "
97157|NCT02295488|"~     Currently, most of the protocols used for desensitization to Hymenoptera venoms consist of a~     very rapid increase in doses of venom extracts administered during the SIT in a day without~     systemic reaction of the patient which is not yet explained. The hypothesis is that this good~     tolerance is due to a rapid decrease in the response of mast cells and basophils to the~     allergen..~      The main objective is to study basophil activation in response to the allergen during the~     first day of desensitization, measured by basophil activation test.~      The initiation of desensitization follow a protocol of rapid growth rates. The basophil~     activation level in the course of desensitization will be analyzed by flow cytometry after in~     vitro stimulation by allergen.~      Changes in T cell polarization is also analyzed by flow cytometry. Evolution of the~     expression of different proteins in blood basophils will be studied by measuring their~     messenger RNAs~   "
97158|NCT02295475|"~     ASTRO-APS is a prospective, randomized, open-label blinded endpoint pilot study among~     patients with a clinical diagnosis of the AntiPhospholipid Syndrome and are already taking an~     anticoagulant for the secondary prevention of thrombosis (blood clots). Subjects will be~     randomized to receive either warfarin (target INR range 2-3) or apixaban 5 mg twice daily.~     Patients will follow up with the study team for 13 months. 2 in-clinic follow-up visits will~     be performed as well as 4 telephone follow-up visits. Study participants will be asked to~     consent to follow up telephone calls and questionnaires at 3 month intervals following the~     completion of the study procedures for the main portion of the study.~   "
97159|NCT02295462|"~     Background: Up to 90% of nursing home residents with dementia experience behavioural and~     psychological symptoms like apathy, agitation, and anxiety. According to analyses of~     prescription prevalence in Germany, antipsychotic drugs seem to be prescribed as first line~     treatment of neuropsychiatric symptoms in persons with dementia. A huge number is prescribed~     for inappropriate reasons and too long without regular review. The use of antipsychotics is~     associated with adverse events like increased risk of falling, stroke, and mortality. This~     study aims to investigate whether a person-centered care approach developed in the United~     Kingdom can be adapted and implemented in German nursing homes. The aim of the investigators~     trial is to achieve a clinically relevant reduction of the proportion of residents with alt~     least one antipsychotic drug prescription.~      Methods/Design: Cluster-randomised controlled trial comparing an intervention group (two-day~     initial skill training on person-centred care and on-going training and support programme)~     with a control group receiving optimised usual care. Both study groups will receive a~     medication review by an experienced psychiatrist with feedback to the prescribing physician.~     Overall, 36 nursing homes from East, North and West Germany will be included and randomised.~     The primary outcome is defined as the proportion of residents receiving at least one~     antipsychotic medication at 12 months. Secondary outcomes are residents' quality of life,~     behavioural and psychological symptoms of dementia as well as safety parameters like falls~     and fall-related medical attention. Cost parameters will be collected and process evaluation~     will be performed alongside the trial.~   "
97209|NCT02294812|"~     In this study, the investigators are testing whether cognitive training can lead to~     improvements in speech perception for individuals with hearing loss. Individuals will~     complete 20 hours of cognitive training that is designed to improve cognitive abilities such~     as short term memory and attention. The investigators predict that cognitive training that~     improves the cognitive abilities affected by hearing loss will improve speech perception.~   "
97392|NCT02292433|"~     Study B1621018 will assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics~     of Two Dose Levels of Pf-04937319 in Japanese Subjects with Type 2 Diabetes Mellitus As~     Monotherapy~   "
97160|NCT02295449|"~     Background: Bracco has released the VueBoxTM-Prostate software, aimed at distinguishing~     prostate cancer from prostate benign peripheral zone (PZ) at contrast-enhanced ultrasound~     (CEUS) using SonoVue® as contrast agent.~      The software analyses the ascending phase of enhancement (wash-in) and calculates the mode~     and the dispersion (sigma) of the wash-in rate in a given region of interest. The diagnosis~     of cancer is based on the combination of these two parameters.~      The main objective of the study is to evaluate the diagnostic value of the VueBoxTM-Prostate~     software in distinguishing prostate cancer from normal PZ at contrast-enhanced ultrasound~     (CEUS).~      The secondary objective is to evaluate the diagnostic value of the wash-out rate, the time to~     peak, the transit time and the area under the enhancement curve (parameters not used by the~     VueBoxTM-Prostate software) in distinguishing prostate cancer from prostate benign peripheral~     zone at contrast-enhanced ultrasound (CEUS).~      The study will enroll patients referred for prostate biopsy. The US transrectal probe will be~     inserted and the local anesthesia performed as per the institution's standard of care~     protocol. Then, the biopsy operator will choose an axial plane likely to contain cancer (e.g.~     based on MRI or Digital rectal examination results). Half a vial (2.4 ml) of SonoVue® will~     then be injected and the ultrasound enhancement of this plane will be recorded during 2~     minutes while the biopsy gun is already in place. Then, the biopsy will be taken while the~     recording is still on, so that it will be possible to calculate quantitative enhancement~     parameters at the exact location of the biopsy.~      Then, the operator will choose a plane that is likely not to contain cancer in the opposite~     prostate lobe and the same process will be repeated with injection of the second half of the~     vial.~      The rest of the biopsies will be performed as per the institution's standard of care~     protocol.~      The two recordings will be sent to Bracco's Research center in Geneva in order to:~        -  Predict the biopsy result (cancer vs benign) based on the VueBoxTM-Prostate software~          results~        -  Calculate the wash-out rate, the time to peak, the transit time and the area under the~          enhancement curve at the biopsy location.~      The two biopsy samples performed after the injection of SonoVue® (as the rest of the biopsy~     samples) will be processed and analysed at the institution's department of Pathology and~     their results will be blinded to the Bracco's Research center.~      The correlation between the biopsy results, the VueBoxTM-Prostate software results and the~     wash-out rate, time to peak, transit time and area under the enhancement curve will be~     performed by the study investigator.~      In total, 130 patients will be included (hypotheses of 20% of malignant biopsy cores and of~     an area under the ROC curve of 0.85 for the VueBoxTM-Prostate software).~   "
97161|NCT02295436|"~     The primary objective of the the study was to evaluate the pharmacokinetic properties of~     minodronic acid tablets following single and multiple oral administration in healthy Chinese~     subjects. Additionally, the effects of age and food on minodronic acid pharmacokinetics was~     also explored.~   "
97162|NCT02295423|"~     The investigators hope to survey anesthesiologists who have participated in a non-CME~     regional anesthesia workshop at VAPAHCS over the past 4 years on the number and types of~     nerve block procedures that they performed, nerve localization method (e.g., ultrasound,~     electrical stimulation, or both), and whether the nerve blocks performed were~     single-injection or catheter-based.~   "
97163|NCT02295410|"~     The intent of this study is to assess whether cognitive functioning improves as~     Post-Traumatic Stress Disorder (PTSD) symptoms decrease as a step toward developing an~     objective measure of PTSD improvement. The study also evaluates the feasibility and~     effectiveness of home-based telemental health care (HBTMH) compared to usual care in the~     treatment of rural Veterans with posttraumatic stress disorder (PTSD). For this~     assessment-only study, the investigators plan to assess approximately 200 Veterans in total,~     of which 150 will be undergoing regular evidenced-based therapy (EBT) for PTSD, and 50 will~     be receiving other treatment as usual (TAU). The 150 veterans in the EBT group will be~     undergoing Cognitive Processing Therapy (CPT), Cognitive-Behavioral Couple Therapy (CBCT),~     Prolonged Exposure (PE), or Seeking Safety (SS) treatment for PTSD in clinic or via~     home-based telemental health (HBTMH). The study will also assess a comparison group of~     approximately 50 rural Veterans with PTSD diagnoses who are receiving treatment as usual~     (TAU) (neither EBT nor HBTMH). The HBTMH patients will be recruited from an Office of Rural~     Health (ORH) funded project to VA Pacific Island Health Care System (VAPIHCS), based at the~     National Center for PTSD (NCPTSD) and funded to offer 100 rural Veterans mental health~     treatment in their homes. This research protocol intends to assess rural veterans with PTSD~     who are being seen within this clinic versus those who have been referred for HBTMH yet who~     are ineligible for pragmatic purposes, with outcomes including feasibility,~     cost-effectiveness, and clinical effectiveness. The cognitive change will also be measured in~     patients with PTSD diagnoses receiving EBT PTSD treatment at VA clinics in the Pacific~     Islands.~   "
97164|NCT02295397|"~     Patients with history of a food allergy to hazelnut, walnut or celeriac will undergo food~     provocation with a dose of the allergenic food to which 5% of the respective food allergic~     population (ED05) has been calculated to respond with allergic reactions (single shot study).~      In patients with a hazelnut or peanut allergy a double-blind placebo controlled food~     challenge with cookies containing either placebo or hazelnut and peanut respectively will be~     performed to determine threshold levels eliciting an allergic reaction. The results for~     threshold levels determined by cookie matrix will be compared to the results gained from the~     EuroPrevall project (matrix comparison study).~      In patients with a walnut allergy double-blind placebo controlled provocation with walnut~     will be combined with the intake of proton pump inhibitor (PPI) or with placebo to assess the~     impact of PPI on the threshold level and on the clinical manifestation.~   "
97165|NCT02295384|"~     For the majority of patients, management of HIV-1 infection involves effective and well~     tolerated antiretroviral therapy with simplified pill load and dosing, exemplified by the~     availability of single tablet regimens (STRs) with single tablet once daily dosing. STR~     therapy has been shown to improve adherence and reduce hospitalisations (Cohen et al., 2013;~     Sax et al., 2012).~      However, the aging of the HIV cohort in Australia and globally has raised issues of~     increasing co-morbidities and consequent polypharmacy to manage these (Jansson & Wilson,~     2012; Edelman et al., 2013).~      Polypharmacy may not only impact on adherence, but also increases the potential for drug-drug~     interactions (Holtzman et al., 2013).~      Stribild, a highly effective STR, contains cobicistat to boost the levels of the component~     integrase inhibitor, elvitegravir. Cobicistat does not have antiretroviral activity, but acts~     by inhibiting Cyp3A4 of the cytochrome p450 metabolic pathway. Other drugs metabolized via~     this pathway may be affected by this drug-drug interaction (Rogatto et al., 2014).~     Additionally there is evidence of increased risk of nephrotoxicity with co-administration of~     tenofovir and non-steroidal anti-inflammatory medication (NSAIDS) (Marcotte et al., 2008).~      Data on use of concomitant medications in Australian patients with HIV is sparse. This study~     aims to determine, in a large caseload community HIV practice, the use of concomitant~     medications in HIV, patient pill load and dosing frequency, and potential drug-drug~     interactions with stribild.~   "
97166|NCT02295371|"~     Prospective reporting of safety incidents concerning drug treatment by approximately 120~     primary care physicians or pediatricians during 2015.~   "
97229|NCT02294552|"~     This study evaluates the efficacy of high-dose post-transplantation cyclophosphomide as~     graft-versus-host disease (GVHD) prophylaxis after allogeneic stem cell transplantation in~     patients with different risk of GVHD. The risk-adapted strategy involves using single-agent~     cyclophosphomide in recipients of matched bone marrow graft, and combining cyclophosphomide~     with tacrolimus and mycophenolate mofetil in recipients of matched peripheral blood stem~     cells and mismatched bone marrow.~   "
97167|NCT02295358|"~     This study is designed with the intention to further elucidate the effects of omega-3 fatty~     acids on intraocular pressure (IOP) and signs/symptoms of dry eye. Prior studies have shown~     statistically significant lowering of IOP with use of omega-3 fatty acids but have only been~     performed in animal models. This study will be the first to attempt replication in human~     models. A limited number of studies have shown an increase in tear production/volume as well~     as a decrease in the subjective symptoms of dry eye, but more studies are needed to better~     define these effects. Better understanding of the effects of this supplement on intraocular~     pressure and dry eye will contribute to the expanding knowledge about the pathophysiology of~     glaucoma/ocular hypertension and dry eye syndrome and potentially lead to further studies~     about new potential treatment options for these conditions.~   "
97168|NCT02295345|"~     Despite the literature showing cognitive behavioural therapy for insomnia (CBT-I) to be~     effective in a variety of populations including postpartum women, as well as the demonstrated~     harmful consequences of sleep disturbances in late pregnancy, no trials have investigated its~     efficacy during pregnancy. This project will investigate the efficacy and acceptability of~     cognitive behavioral therapy for insomnia (CBT-I) in pregnancy.~   "
97169|NCT02295332|"~     This is a single center, randomized, double-blind, placebo-controlled, single ascending dose~     study that will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic~     effects of single doses of RG7625 in healthy male and female volunteers.~      The study will employ an interleaved cohort ('leapfrog') design in which dosing is alternated~     between two cohorts and each individual within a cohort will receive study drug dosing on~     four occasions - in effect giving a four treatment, four period, four-way crossover for each~     individual. The minimum duration for each participant is approximately 8 weeks.~   "
97170|NCT02295319|"~     The present non-blinded randomized controlled trial (RCT) investigates the effect of a~     comprehensive discharge model in adult medical patients discharged directly home from an~     Acute Admission Unit (AAU). In addition, eligible patients should have, at least, one~     hospital admission 12 months prior to index hospitalization and be discharged for further~     follow-up by general practitioner, home care nursing or in an out-patient clinic. The model~     consists of 3 main steps during the short term stay in the AAU. First, patients are screened~     for pre-hospital conditions that might have contributed to the index hospitalization i.e.~     functional ability, ongoing treatment including drug treatment, need for additional~     assistance to maintain daily living, relatives, and use of e.g. hearing aid, glasses, walker.~     Second, at point of discharge there will be a thorough assessment of the discharge plan~     focusing on the patients' comprehension of the discharge plan as well as accept of the~     suggested treatment and follow-up. Third, within 2 days after discharge the patient will~     receive a discharge letter by email or postal mail written in plain language and repeating~     the information provided in the discharge summary to the general practitioner. Subsequently,~     the patient will receive a telephone follow-up from the research nurse addressing the content~     in the discharge letter and possible unresolved issues related to the index hospitalization.~     Patients in the control group receives the usual discharge practice in the AAU which does not~     include a discharge letter to the patient and telephone follow-up after discharge.~      The primary endpoint is number of readmissions within 72 hours and 30 days after discharge.~     Secondary endpoints are healthcare service utilization within 30 days after discharge this~     includes number of contacts to general practitioner, out-of-hours physicians, emergency~     departments and if possible visits by home care nurses. Additionally, Quality-of-Life~     measured 30 days after discharge by the questionnaire EQ5D and Patient Experience of the~     discharge process is measured 7 days after discharge by a Danish national patient experience~     survey - serves as secondary endpoints.~   "
97171|NCT02295306|"~     Sleep disordered breathing; specifically obstructive sleep apnea (OSA) is a disease affecting~     8-12% of the general population and often more than 70% of the bariatric surgical population.~     OSA is characterized by the repetitive collapse of the upper airway, causing a reduction or~     cessation in airflow and decreases in oxygen saturation. These events are resolved by~     arousals from sleep, reducing sleep quality and leading to excessive daytime sleepiness. An~     in-laboratory polysomnography (PSG) is the gold standard for the diagnosis of OSA.~      Previous studies have established obstructive sleep apnea (OSA) as a potential independent~     risk factor for postoperative complications, adverse surgical outcomes, and longer hospital~     stays.~      Patients with OSA have an increase in postoperative complications, the most frequent being~     oxygen desaturation, postoperative atelectasis and increased postoperative pain. Despite the~     clear risks, OSA remains under diagnosed with an estimated 25-30% of patients at a high risk~     for OSA. It has been suggested that OSA events may be even more frequent post operatively~     because of the residual effects of anesthesia and the use of potent pain medications such as~     opioids. Postoperatively apneas often go undetected and untreated. The use of supplemental O2~     may mask any desaturations and there is no convenient technology to noninvasively monitor~     ventilation to detect apnea and hypopnea in post-surgical patients.~      New advances in technology and digital signal processing have led to the development of an~     impedance based Respiratory Volume Monitor (RVM). The RVM (ExSpiron™, Respiratory Motion,~     Inc.; Waltham, MA) has been shown to provide accurate real-time, continuous, non-invasive~     measurements of tidal volume (TV), minute ventilation (MV) and respiratory rate (RR). Our~     main hypotheses are that the non-invasive, impedance-based RVM monitor will accurately~     reflect TV, RR and MV during sleep and will detect apneas and hypopneas accurately.~   "
97172|NCT02295293|"~     Coronary heart disease and stroke are two main causes of human deaths and is directly related~     to increased levels of plasma lipids.High total cholesterol and low high density lipoprotein~     cholesterol concentrations are often associated with endothelium dysfunction and~     inflammation, which can be followed by atherosclerosis.~      Rhus coriaria L. (Rhus) with the public name of Somagh is a plant species in the~     anacardiaceae family that is used as a food supplement, spice in Middle East region (Iran,~     Turkey and Arabic countries).~      In a double blind randomized placebo-controlled clinical trial, the investigators want to~     evaluate the effects of Somagh (Rhus coriaria L.) on serum lipid levels of patients with~     hyperlipidemia.~   "
97173|NCT02295280|"~     To determine if the intravenous administration of Metoclopramide and diphenhydramine in~     combination can effectively treat headaches in pregnant patients in those refractory to~     acetaminophen when compared to codeine~   "
97174|NCT02295267|"~     Accurate diagnosis of food allergy depends on the identification of the causative allergenic~     molecule(s). The proposed study intends to investigate and compare the pattern of IgE~     antibody sensitisation in walnut allergic subjects from three different regions of Europe~     (south (SEU) and central/north (C/NEU), to evaluate the diagnostic utility of a panel of~     novel allergen reagents.~   "
97175|NCT02295254|"~     The human gut contain a wide range of microorganisms creating the gut microbiome. The~     microbiome has great impact on metabolic and immunologic processes and responses. Travelers~     who travel to tropical destinations where the intestinal infection risk is high are prone to~     microbiome changes. During the current study the travelers will give feces specimen before~     and after the travel and their microbiome will be analyzed.~   "
97230|NCT02294539|"~     The purpose of this study is to investigate which combination therapy is more effective for~     improving the blood pressure (BP) and AM central SBP in hypertensive patients:Angiotensin II~     receptor blocker (ARB) plus calcium channel blocker (CCB) or ARB plus diuretics~   "
97231|NCT02294526|"~     Work hypothesis~      A diet rich in sardine will improve the metabolic control in type 2 diabetes patients.~   "
97393|NCT02292420|"~     The purpose of this study is to determine the normal reference values of pulse oximetry~     plethymographic waveform parameters in Chinese population.~   "
97176|NCT02295241|"~     The primary aim of this study is to compare traditional muscle function tests with~     computerized versions using body-worn motion sensors and video motion analysis of the same~     tests. The investigators selected the Timed Up and Go (TUG) test as the investigators primary~     variable for this aim with several other function tests (e.g., repeated chair rise, 6-meter~     walk, 2-minute walk, Romberg stance, semi-tandem / tandem stance) as secondary variables. The~     investigators primary hypothesis is that the computerized versions of the TUG test are highly~     correlated (>0.9) with the traditional method, but with comparable or better reproducibility.~     Secondary analyses will correlate other function tests with their computerized version, again~     with the hypothesis that they are highly correlated and that computerized versions are of~     similar or better reproducibility. This analysis will also compare traditional assessments of~     balance with a computerized balance method, computerized dynamic posturography.~   "
97177|NCT02295228|"~     It is essential that serum 25(OH)D changes following surgery be clarified, and the~     mechanism(s) underpinning these changes be identified. As such, the overarching hypothesis of~     this study is that elective total hip arthroplasty reduces serum total 25(OH)D.~   "
97178|NCT02295215|"~     The prevalence of Chagas' disease continues high even in the developed countries. Chagasic~     Cardiomyopathy with preserved ventricular function is an understudied form of Chagas disease.~     Since a majority of patients with these changes progress to dilated form with ventricular~     dysfunction with all its serious consequences, it is interesting to better understand the~     pathophysiology of the disease at the stage where there electrocardiographic changes and~     preserved ventricular function. And besides, search strategies to slow the progress, or even~     prevent the chronic phase of the disease. For this reason the investigators will evaluate the~     effects of exercise training in patients with Chagas cardiomyopathy without ventricular~     dysfunction.~   "
97179|NCT02295202|"~     Obstructive Sleep Apnea (OSA) is a common condition that may induce hemodynamic and metabolic~     dysregulation. However, it is not clear if OSA is a mere epiphenomenon or contributes to~     increase the morbidity associated with metabolic syndrome. This study was designed to~     evaluate the impact of OSA treatment with CPAP in consecutive patients with metabolic~     syndrome.~   "
97180|NCT02295189|"~     Osteoarthritis is a disabling disease of the joint spaces and has a high impact on society~     due to the amount of people who are affected by the disease. Nonoperative management is a~     mainstay of therapy in most patients. Ketorolac tromethamine and triamcinolone acetonide~     intra-articular knee injections will be compared in a prospective, double-blinded, randomized~     trial in subjects with knee osteoarthritis. Subjects will be enrolled from the Orthopaedics~     Clinic based on inclusion and exclusion criteria. Intra-articular knee injection of ketorolac~     tromethamine or triamcinolone acetonide will be performed under ultrasound guidance. Multiple~     outcome measures will be performed throughout the six month period of follow-up. The~     investigators predict ketorolac tromethamine will have a longer duration of pain relief when~     compared to triamcinolone acetonide. The investigators predict there will be no differences~     between the two intra-articular knee injections in terms of function using validated scoring~     instruments.~   "
97181|NCT02295176|"~     Aim of the study is to evaluate the effects of Armolipid Plus on insulin sensitivity in~     patients with MetS and increased LV mass.~      168 patients will be enrolled in this randomized, double-blind, parallel-group,~     placebo-controlled trial and treated for 24 weeks.~   "
97182|NCT02295163|"~     Androgen deprivation therapy (ADT) is widely used as standard therapy in the treatment of~     locally advanced and metastatic prostate cancer. Hot flushes and night sweats are one of the~     main side-effects of ADT. There are no successful and well-tolerable treatment options~     available. A possible treatment for hot flushes is stellate-ganglion block (SGB), used as a~     means of interrupting parts of the sympathetic nervous system involved in temperature~     regulation.~      Objective of this study:~      To assess the short-term efficacy of stellate ganglion block on hot flush reduction versus~     sham procedure~   "
97183|NCT02295150|"~     This study is a prospective evaluation of the relationship between lean body weight and~     anti-Xa activity and 5700 International Units (IU) nadroparin 4 hours after subcutaneous~     administration in morbidly obese patients after bariatric surgery.~   "
97184|NCT02295137|"~     Abdominal Aortic Aneurysm (AAA) is a potentially life threatening condition. If the aneurysm~     ruptures, the mortality can be as high as 80%. Endovascular aneurysms repair (EVAR) is a~     minimal invasive procedure and has been widely used on treating AAA. Advanced endovascular~     techniques are used to treat patients with more complex pathology by using custom-made~     devices and additional stents. In order to accomplish the technical success on advanced EVAR,~     with the current imaging equipment and technique for EVAR procedures (i.e. live x-ray~     fluoroscopy and 2-D digital subtraction angiography (DSA)), multiple angiograms on the target~     arteries (arteriograms) are required. Subsequently patients are exposed to higher dose of~     contrast and radiation, compared to conventional EVAR. This study is to assess the~     feasibility of proper visceral and renal arteries catheterization using a 3D model obtained~     from pre-procedural computed tomographic angiography (CTA), fused with real-time fluoroscopy,~     without contrast injection or angiographic run-offs thus minimizing the contrast use and~     patient radiation exposure while achieving procedure success during Advanced EVAR.~   "
97185|NCT02295124|"~     The study aims to compare the incidence of side effects caused by Oxycodone and~     Hydromorphone.~   "
97194|NCT02295007|"~     Children 2-11 years of age who are given the influenza vaccine (inactivated influenza (IIV)~     or live attenuated influenza vaccine (LAIV)) as part of their routine care can enroll in this~     study if their parent has the ability to receive and send text messages. Children enrolled in~     this study will be observed daily for an eight-day period starting on the day of vaccine~     administration, and then continuing over the next 7 days, and then weekly for 42 days. On the~     day of enrollment and nightly for the next seven days, the parent will report via text~     message what their child's highest temperature is. If fever is present, they will then be~     prompted for additional information including other symptoms, antipyretic use and medical~     care sought. On day 3 as well as weekly from day 7 through day 42 post-vaccination, parents~     will be asked via text message about breathing problems, specifically cough, wheezing and~     chest tightness. They will also be asked about medications taken and care sought. The purpose~     of this study is to assess the feasibility of collecting this data.~   "
97186|NCT02295111|"~     Chronic pelvic pain (CPP) is a debilitating condition that affects over 1 million women in~     the United Kingdom. The annual healthcare costs are estimated at over £150 million. Proven~     interventions which include the use of analgesics or hormonal treatments are unsatisfactory~     in many cases.~      The investigators believe that the meridian balance method (BM) electro-acupuncture (EA)~     treatment (which includes a Traditional Chinese Medicine Health Consultation [TCM HC]) may be~     helpful in the management of CPP. Studies on the mechanisms of EA have demonstrated an~     analgesic effect. A recent individual patient data meta-analysis on the use of acupuncture~     for four chronic pain conditions found a small statistically significant effect size when~     compared to sham acupuncture. The effect size was larger and statistically significant when~     compared to usual care controls. This meta-analysis, and other large studies, suggests that,~     in addition to this analgesic effect, the interaction between the patient and the healthcare~     provider also plays a role in its effect on painful symptoms.~      Our hypothesis is that the meridian BMEA treatment alleviates pain, and improves physical and~     emotional functioning, in women with CPP.~      The investigators plan to undertake a single centre pilot study to assess the feasibility of~     performing a future three-armed randomised controlled, parallel group design trial to~     determine the efficacy of the meridian balance method electro-acupuncture (BMEA) treatment in~     the management of women with CPP.~      The primary objective is to determine whether it is possible to achieve acceptable~     recruitment and retention rates within defined inclusion/exclusion criteria.~      The secondary objectives are to determine the effectiveness and acceptability to patients of~     the proposed methods of recruitment, randomisation, interventions and assessment tools.~      The investigators aim to recruit 30 women with CPP in NHS Lothian over a 12-month period and~     randomise them to BMEA treatment, TCM HC or standard care (SC). Response to the intervention~     will be monitored by validated pain, physical and emotional functioning questionnaires at~     weeks 0 (baseline), 4 (end of study) 8 and 12. Focus group discussion to gain feedback on~     study experience will be conducted at the completion of the study.~   "
97187|NCT02295098|"~     The investigators plan to compare the incidence of successful placement of epidural pain~     catheters versus paracostal catheters for the control of pain and prevention of pulmonary~     complications for adult trauma patients with blunt chest wall trauma resulting in multiple~     rib fractures. When a trauma patient has > or = to 3 rib fractures on the same side, is being~     admitted to the Surgical ICU, and is encountered within 72 hours from the time of their~     injury, they will be eligible for the study. If they (or a proxy) choose to participate,~     consent will be obtained and they will randomly be assigned to receive either an epidural or~     paracostal catheter for pain control. The aim of the study is to determine if paracostal~     catheters are noninferior to epidurals for controlling pain in multisystem trauma patients.~     Secondarily the investigators will evaluate success and time of placement of the assigned~     intervention and follow the patient throughout their hospital course to compare the success~     of analgesia provided by each modality along with any complications and/or benefits of the~     two types of catheters.~   "
97188|NCT02295085|"~     The Fernald Community Cohort consists of the 9782 persons who were enrolled in the Fernald~     Medical Monitoring Program (FMMP) (1990-2008). The initial comprehensive examination~     conducted as part of the Fernald Medical Monitoring Program (FMMP) began in the autumn of~     1990. The FMMP provided 9,782 initial examinations and 42,775 re-examinations. An extensive~     computerized database and biospecimen repository was created to provide research resources~     for future studies. All questionnaire, examination and diagnostic procedure data collected~     from the FMMP were [coded by certified medical record coders,] double entered with~     verification into a SAS database on site of the examinations. Cryo-preserved blood and urine~     samples were collected at enrollment and at various intervals throughout follow-up. At the~     first examination three 1-ml aliquots of whole blood, plasma, serum, urine and urine with~     buffer were obtained from each participant (15 aliquots per person) for future analyses.~     Additional whole blood and serum was obtained in 1996-1997 and 2006-2008. Specimens have been~     stored in -80 degree freezers; over 160,000 biospecimens are in the archive. Since 1994, the~     FCC has had an established procedure for sharing data and biospecimens with qualified~     researchers. Both the policy and application forms can be found at~     www.eh.uc.edu/fmmp/research.~   "
97189|NCT02295072|"~     The ActiveBrains project aims to examine whether a 5-months physical exercise program has~     benefits on cognition and brain, as well as on selected physical and mental health outcomes~     in preadolescent overweight/obese children.~   "
97190|NCT02295059|"~     The investigators study aims to determine biological changes associated with a low vs high~     dose of omega 3 fatty acids, docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), over 12~     months in women at risk for recurrent breast cancer. The objectives of the trial are to~     develop mammary epithelial, adipose tissue specific markers of exposure and response to omega~     3 fatty acid supplements that can be carried forward into definitive intervention trials of~     omega 3 fatty acids for breast cancer prevention. The investigators will randomize 80~     subjects with hormone receptor negative, HER-2/neu overexpression positive or negative breast~     cancer to either a high or low dose of omega 3 fatty acids. Using fine needle aspiration to~     procure cellular samples of breast epithelial and adipose tissue, the investigators will~     determine the effects of omega 3 fatty acids on mammary specific biomarkers of response.~   "
97191|NCT02295046|"~     This study is to assess the bioequivalence between Amlodipine besylate/Atorvastatin calcium~     Tablets 10mg/80mg of Dr. Reddy's Laboratories Limited, India and CADUET® (amlodipine besylate~     and atorvastatin calcium) tablets 10mg/80mg of Pfizer Ireland Pharmaceuticals Dublin, Ireland~     in Healthy Male and Female Volunteers under Fasting conditions.~   "
97192|NCT02295033|"~     Radiation therapy may kill any tumor cells remaining after surgery. This randomized phase III~     trial is studying the effect of an extra dose of radiation therapy (Boost dose) after breast~     conserving surgery and 50 Gy adjuvant external beam radiotherapy to see how well it works~     compared to no further therapy in treating women with early breast cancer that has been~     surgically removed.~   "
97193|NCT02295020|"~     The objectives of the study are 1.) to evaluate pain relief following the application of the~     Bioskin Ten-7 knee brace and 2.) to determine if use of the Bioskin Ten-7 knee brace is more~     effective at reducing inflammation than standard of care alone using synovial fluid cytokine~     analysis and validated outcome measures.~   "
97195|NCT02294994|"~     The aim of the study is to investigate the efficacy and safety different dose of GPIIb/IIIa~     inhibitor (tirofiban) in interventional treatment of complex coronary artery disease ,which~     include bifurcation lesion, left main lesion, multiple vessel disease, intracoronary~     thrombus, SYNTAX score>26,chronic total occlusion disease. The primary endpoint is all-cause~     mortality. Secondary endpoints are incidence of major bleeding and the rate of site access~     complication.~   "
97196|NCT02294981|"~     The purpose of this study is to determine the best dosing strategy when using Excimer Laser~     to treat plaque-type psoriasis. In this study, half of the body's psoriasis will be treated~     with a new dosing strategy, and the other half will be treated with the conventional method.~     We hope to show that the new dosing strategy will result in faster improvement of psoriasis.~   "
97198|NCT02294955|"~     The objective is to compare the efficacy of 2 treatment strategies, catheter ablation of~     atrial fibrillation versus optimized pharmacological therapy, in patients with symptomatic~     atrial fibrillation.~      It is a randomized, prospective, controlled, open-label multicentre, parallel-group study~     including 116 patients. Inclusion criteria are patients aged 30-70 years with symptoms~     related to atrial fibrillation and who have failed or been intolerant to at least one~     anti-arrhythmic drug, with at least one atrial fibrillation episode documented on ECG during~     the previous 12 months and at least one symptomatic episode during the previous 2 months or~     at least 2 symptomatic episodes of persistent AF in the previous 12 months.~      Main exclusion criteria are patients who have tested 2 or more anti-arrhythmic drugs for~     rhythm control, uncontrolled hypertension, valvular disease requiring anticoagulation,~     planned valve surgery within 2 years, contraindication to treatment with anticoagulants,~     heart failure, left atrial diameter > 60 mm, unstable angina or acute myocardial infarction~     within the last 3 months, cardiac revascularization procedure within the last 6 months, prior~     cardiac surgery or planned cardiac corrective surgery within 1 year, prior AF ablation~     procedure.~      The primary endpoint is general health-related quality of life at 12 months follow-up. The~     main secondary endpoints are morbidity and mortality as composite outcome, cardiovascular~     hospitalization, symptoms, heart failure, left atrial and ventricular function and diameters,~     exercise capacity, health care economics, rhythm, atrial fibrillation burden, successful~     versus failed treatment, safety and cross-overs over time.~      Patients will receive a cardiac monitor, implanted subcutaneously, which will monitor the~     heart rhythm during a two month Run-in period, for the definition of the basic atrial~     fibrillation burden. Patients will be randomly assigned to an antiarrhythmic drug (for rhythm~     or rate control) or to left atrial catheter ablation. Evaluation of outcome is at 12, 24, 36~     and 48 months of follow-up, while health economy will be evaluated at 24 and 48 months of~     follow-up.. In case of documented disease progression or unacceptable toxicity, subjects will~     be switched to the alternative regimen. The main statistical analysis of the primary endpoint~     will be based on the intention-to-treat population. The trial duration is 48 months.~   "
97199|NCT02294942|"~     A double-blind, randomized, placebo-controlled, parallel study to evaluate the effects of~     add-on RANCAD on exercise tolerance and angina frequency in patients with stable angina~     pectoris.~   "
97200|NCT02294929|"~     Prospective and explorative clinical study. The objective is to assess the clinical efficacy~     of pulmonary vein isolation using the Arctic Front Advance cryoballoon in patients with~     longstanding persistent atrial fibrillation (AF) at one year follow up.~      44 subjects will be enrolled. Patients with longstanding persistent AF, with continuous AF~     duration longer than one year, who have not previously undergone an AF ablation procedure,~     and have symptoms related to AF corresponding to at least European Heart Rhythm Association~     (EHRA) score 2, will be studied. Patients should have failed at least one betablocker or~     class I or III antiarrhythmic drug.~      Excluded are those with congestive heart failure with New York Heart Association (NYHA) class~     3 or more, left ventricular ejection fraction < 40%, left atrial diameter ≥ 60 mm,~     significant valvular disease or planned cardiac intervention within next 12 months, and~     conventional contraindications for AF ablation procedures.~      Patients will be screened with echocardiography and response to electrical cardioversion.~     Following conversion to sinus rhythm, amiodarone will be initiated to maintain sinus rhythm.~     Pulmonary vein isolation will be performed using the Arctic Front Advance cryoballoon~     ablation catheter. Pulmonary vein conduction block will be assessed by a circular mapping~     catheter.~      All patients will be subject to electroanatomical voltage mapping during sinus rhythm for~     demonstration of extent of atrial myocardial lesions after ablation.~      Patients will be followed every third month up to one year after the ablation procedure.~     Arrhythmia monitoring during follow up will be performed by 7 day Holter monitoring at 6, 9~     and 12 months follow up, including a 12 lead ECG. 12 months follow up for symptoms, EHRA~     score, and quality of life. Patients with symptomatic recurrence requiring a redo ablation~     procedure will be re-studied after 8-12 months while asymptomatic patients will be studied at~     12 months follow up.~      Primary end-Point is Clinical success based on symptoms and presence of AF. Secondary~     end-Points include freedom from AF without antiarrhythmic drugs at 6 and 12 months according~     to 7 day Holter and ECG, Rhythm, AF burden, AF profile, Quality of Life, Symptoms, Adverse~     Events, atrial size and function, Biomarkers, extent of scar tissue, predictive factors of~     freedom from AF, complications, hospitalization and Health economics.~   "
97201|NCT02294916|"~     The purpose of this study was to compare the Pentax AWS, Intubrite and AirTraq to Miller~     laryngoscope during pediatric resuscitation with and without chest compressions.~   "
97202|NCT02294903|"~     To assess the early histological outcomes of tissue ablation, adverse events and~     genitourinary side-effect profile of focal radiofrequency ablation using a coiled bipolar~     device to treat localized prostate cancer in men with clinically significant prostate cancer.~   "
97203|NCT02294890|"~     At the standard follow-up moment one year after primary TKA for gonarthrosis, all patients~     will be checked for signs of fibrosis diathesis. This will be done by examining their hands~     for Dupuytren's nodules and contractures and recording risk factors associated with increased~     severity and risk of recurrence of Dupuytren's contracture. These include family history,~     bilateral DD, and ectopic lesions, age of onset less than 50 years, male gender, Ledderhose~     disease, first ray involvement, multiple ray involvement and ectopic fibromatosis.~      This way, two groups of patients will be identified: those with and those without signs of~     fibrosis diathesis. For both groups, the range of motion (ROM) of the operated knee at 3 and~     6 months will be retrieved in the charts, the ROM at 12 months will be measured at that time.~     Also, additional procedures performed to increase ROM postoperatively will be retrieved from~     the charts (e.g. continuous passive motion, mobilization under anesthesia). Other causes for~     knee stiffness will have to be recorded, since these will be the most important exclusion~     criteria.~      In the patients with clear signs of finger contractures, any impression of increase of~     contracture over the past 12 months will be recorded.~   "
97204|NCT02294877|"~     The objectives of this program are: to characterize and describe the Mucopolysaccharidosis IV~     type A (MPS IVA) population as a whole, including the heterogeneity, progression, and natural~     history of MPS IVA; to evaluate the long-term effectiveness and safety of Vimizim®,~     including, but not limited to, the occurrence of serious hypersensitivity reactions,~     anaphylaxis, and changes in antibody status; to help the medical community with the~     development of recommendations for monitoring MPS IVA patients and reports on patient~     outcomes to optimize patient care; to collect data on other treatment paradigms, and evaluate~     the prevalences of their use and their effectiveness; to characterize the effects and safety~     of Vimizim treatment 5 years from enrollment in the Registry for patients under 5 years of~     age; to monitor pregnancy exposure, including maternal, neonatal, and infant outcomes; and to~     monitor patients who have completed the MOR-005 and MOR-007 clinical trials. These patients~     will be encouraged to enroll in the applicable Registry Substudy and will be monitored using~     the MOR-005 and MOR-007 assessment schedules, respectively.~   "
97205|NCT02294864|"~     It is estimated that nearly 27 million US adults have osteoarthritis (OA) and suffer from~     pain . Pulsed Radio Frequency (PRF) is one method that has been successfully used in~     treatment of various etiologies of pain. However there are limited studies and research that~     prove its effectiveness in treating articular pain. The proposed study's primary aim is~     determining if PRF is an effective treatment for chronic osteoarthritic knee pain. This study~     hypothesizes that PRF has analgesic properties immediately after treatment and at least 3~     months afterwards compared to control treatment with physical therapy.~      Additionally this research project addresses several other objectives including:~        1. Provide a controlled study to determine the effectiveness of PRF for intra-articular~          pain~        2. Determine how effective PRF is 1 month and 3 months after treatment for articular pain.~        3. Further scientific evidence on the overall effectiveness of PRF~        4. Provide evidence that PRF likely has other mechanism of action besides direct nerve~          stimulation of inhibitory pain pathways.~        5. Compare the effectiveness of PRF vs Physical Therapy in treating chronic knee~          osteoarthritis.~   "
97210|NCT02294799|"~     Background: Among the instrumental devices that have been proposed over the years to~     integrate the clinical evaluation of temporomandibular joint disorders (TMD), imaging~     techniques are the most studied, showing that magnetic resonance imaging (MRI) is the~     technique most need to describe the anatomy of the TMJ and to evaluate the correlation of~     imaging findings with the clinical diagnosis . Despite the amount available studies on the~     use of MRI for evaluation of TMJ disorders and treatments, there is a lack of studies that~     evaluate the imaging findings after physical therapy. Purpose: To evaluate the influence of~     nonspecific mandibular mobilization about the positioning of the articular disc by MRI in~     individuals with TMD diagnosis of anterior disc displacement with and without reduction~     according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD).~     Analyze the behavior of pain through the numerical scale of pain assessment (END) at baseline~     and after each treatment session, the quality of life of individuals with TMD at baseline,~     immediately, three and six months after the treatment sessions by the World Health~     Organization Quality of Life Assessment (WHOQOL - BREF), and The Patient's Specific~     Functional Scale (PSFS) at baseline and after treatment. The treatment will be performed~     three times a week during four weeks. Metodology: This is a randomized, placebo controlled,~     blind study designed to assess the effects of techniques nonspecific mandibular mobilization~     x placebo. Individuals will be randomized and divided into two groups: Group A (intervention)~     and Group B (placebo). Statistic analysis: The positioning of the articular disc, extracted~     through the use of MRI, will be considered the primary outcome and, as a secondary outcome~     will be assessed the quality of life, pain and function after treatment. The adherence of the~     data to a Gaussian curve will be verified by the Shapiro-Wilk and the data are expressed as~     mean values and standard deviation. Two-way repeated measures analysis of variance with~     Bonferroni post hoc test will be used for inter-and intra-group comparisons. The significance~     level is adjusted p ≤ 0.05.~   "
97211|NCT02294786|"~     Diarrhoea is the most commonly reported adverse events (AE) associated with Lapatinib~     treatment, and is also commonly associated with Capecitabine treatment. Although these events~     are generally mild to moderate in severity, diarrhoea adversely affects the tolerability of~     cancer treatment, and in severe cases diarrhoea has the potential to affect the efficacy of~     treatment due to poor compliance, or treatment interruption or withdrawal. The efficacy of~     Octreotide in the management of cancer treatment-associated diarrhoea has not been~     extensively evaluated in large, well-controlled studies. This is a randomised, multi-centre,~     open-label Phase II study in subjects with Human epidermal growth factor receptor 2~     (HER2)-positive metastatic breast cancer which has progressed following prior therapy, which~     must have included anthracyclines and taxanes and therapy with Trastuzumab in the metastatic~     setting. This study is not placebo controlled, and there is no active comparator. The study~     will evaluate whether the prophylactic use of Octreotide Long Acting Release (LAR) offers a~     clinically meaningful benefit by reducing the frequency and severity of diarrhoea associated~     with treatment with Lapatinib and Capecitabine. Study completion for a subject will be~     defined as the completion of 24 weeks of treatment with Lapatinib and Capecitabine, or~     progression of cancer or the death of the subject during treatment, whichever occurs first.~     Approximately 140 subjects will be randomized out of which 70 will receive octreotide and 70~     will receive no Octreotide~   "
97212|NCT02294773|"~     The aim of this study is to assess the impact of the timing of intrauterine insemination~     (IUI) in relation to the natural surge of luteinizing hormone (LH), as detected by home~     ovulation predictor kits, on pregnancy rates per treatment cycle. The study will take place~     at the offices of Midwest Fertility Specialists and include patients who have been~     independently recommended by their primary physician to undergo ovulation induction with~     clomiphene citrate (CC) or letrozole and IUI as therapy for infertility.~   "
97213|NCT02294760|"~     A recent randomised, controlled, crossover study has shown that sacral nerve stimulation~     (SNS) significantly reduces symptoms and improves quality of life of highly selected patients~     with irritable bowel syndrome (IBS). Relief of IBS symptoms during SNS is associated with~     consistent changes in rectal sensitivity and biomechanical wall properties.~      The aim of the present study is to evaluate long-term efficacy of sacral nerve stimulation on~     symptoms and quality of life in patients with IBS in a randomised, placebo-controlled,~     crossover study.~   "
97214|NCT02294747|"~     Trochanteric fractures represent about half of the hip fractures (with femoral neck fractures~     as the other half). Trochanteric hip fractures are almost always treated surgically with~     internal fixation of the fracture. However there is a debate ongoing for what is the~     appropriate implant to use. For stable fracture patterns the evidence seems to be in favor of~     the sliding hip screw, but for the unstable fractures it is more unclear whether to use a~     intramedullary nail or sliding hip screw with or without a lateral support plate (TSP). The~     role of the TSP in clinical use remains unclear and very little has been published about~     this, but it is believed to be an important contributor of stability to the sliding hip screw~     construct. We are planning a randomized controlled trial on trochanteric hip fractures to~     establish a method for implanting the tantalum markers, to observe the fracture healing~     process and to further investigate the role of the TSP.~   "
97215|NCT02294734|"~     The purpose of this study is to evaluate the efficacy of GSK2269557 administered in addition~     to standard of care in adult subjects diagnosed with an acute exacerbation of Chronic~     Obstructive Pulmonary Disease (COPD). Additionally study will also assess safety,~     tolerability and pharmacokinetic data. The total duration of the study will be 13-14 weeks~     including screening, treatment period and a follow up visit. Subjects will receive once daily~     study treatment administration starting on Day 1. Study is planned to recruit approximately~     120 subjects such that approximately 100 subjects complete the study.~   "
97216|NCT02294721|"~     The aim of this study was to compare four different CPR feedback devices to standard BLS in~     terms of the quality of single rescuer pediatric resuscitation. Therefore, the investigators~     hypothesis was that there would be no difference between CPR methods in terms of chest~     compression quality parameters.~   "
97217|NCT02294708|"~     The purpose of this study is to evaluate whether postoperative postures influence persistent~     sub-foveal fluid after scleral buckle surgery~   "
97218|NCT02294695|"~     To investigate the value of procalcitonin (PCT) kinetics between 0-8-16-24 hours after~     starting empirical antibiotic therapy in critically ill patients, to predict appropriate or~     inappropriate antibiotic treatment.~   "
97242|NCT02294383|"~     The clinical study includes investigation of the outcomes of surgery for biomechanical~     restoration of pelvic floor conditions, monitoring pelvic floor conditions under conservative~     treatment/management, identification and investigation changes of pelvic floor muscle~     contractions and their significance in characterization of pelvic floor conditions,~     assessment of tactile imaging reproducibility, including pelvic floor muscle contraction.~   "
97243|NCT02294370|"~     This study aims at improving the prediction of type 2 diabetes among high-risk individuals by~     examining glucose excursion patterns in subjects with impaired glucose tolerance. In~     addition, this study will show whether the currently used diagnostic test could be replaced~     by an easier and less expensive method.~   "
97219|NCT02294682|"~     GSK2140944 has demonstrated in vitro activity against Neisseria (N.) gonorrhoeae, including~     ciprofloxacin resistant and susceptible strains. This study is a Phase II, randomized,~     multicenter, open-label, dose ranging study designed to inform the optimal oral dose of~     GSK2140944 by further characterizing the efficacy, safety, and tolerability in subjects with~     uncomplicated urogenital gonorrhea due to N. gonorrhoeae. Subjects will be randomly assigned~     to receive either a single 1500 milligrams (mg) or 3000 mg oral dose of GSK2140944.~     Appropriate safety and microbiological assessments will be conducted at the Baseline (Day 1)~     Visit and repeated at the Test-of-Cure (Day 4 to 8) Visit. The study duration will be~     approximately 1 week. Approximately 60 microbiologically evaluable subjects (30 subjects in~     each treatment arm) will complete the study if both arms remain active throughout the study.~   "
97220|NCT02294669|"~     This is a prospective, exploratory study to verify intra-operative handling and safety and to~     collect preliminary short-term safety and efficacy data of the Turris® Facet Fuser, a small~     bioresorbable device for the immediate immobilization of the facet joint.~      Patients eligible for study enrollment will present with degenerative lumbar spinal diseases~     involving the L4/L5 segment and requiring spinal fusion.~   "
97221|NCT02294656|"~     This is an open-label, Phase I/II study evaluating intravitreal ranibizumab (R) vs.~     intravitreal Triesence (triamcinolone acetonide) (T) in subjects with acute pseudophakic~     cystoid macular edema (CME). Twenty consented patients with acute CME after~     phacoemulsification cataract surgery with posterior chamber intraocular lens implantation~     (PE/PCIOL) will be randomized 1:1 to treatment with R or T. R patients will receive three~     monthly R injections, followed by PRN dosing. T patients will receive PRN injections every 3~     months. Clinical CME is defined as clinically evident CME, with visual acuity (VA) typically~     in the 20/40 to 20/200 range. Re-treatment criteria will include clinically evident worsening~     of CME, combined with any of the following:~        -  Any increase in spectral domain ocular coherence tomography (OCT) central macular~          thickness (CMT)~        -  Any observable fluid on OCT~        -  Any qualitatively increased perifoveal leakage/pooling on fluorescein angiography (FA).~      Patients will be followed monthly through 12 months.~   "
97222|NCT02294643|"~     The purpose of the SERENADE trial is to evaluate the safety and efficacy of sarpogrelate in~     patients with CKD or DM after DES implantation.~   "
97223|NCT02294630|"~     Respiratory distress syndrome (RDS), caused by surfactant deficiency, is the leading cause of~     mortality and morbidity in preterm infants. Intratracheal instillation, the only approved~     means of surfactant delivery, requires endotracheal intubation and mechanical ventilation~     with their attendant risks. Interventions that decrease need for intubation and mechanical~     ventilation like noninvasive ventilation (NIV) including nasal continuous positive airway~     pressure, high flow nasal cannula or nasal intermittent mandatory ventilation are~     increasingly being used for initial respiratory support in preterm neonates with RDS to~     improve outcomes. Aerosolized surfactant delivered during NIV is an innovative and promising~     concept for the treatment of RDS - retaining the advantages of early surfactant with alveolar~     recruitment while obviating the risks of intubation and mechanical ventilation. The~     investigators overall hypothesis is that treatment of RDS with aerosolized surfactant in~     preterm infants undergoing NIV is safe and feasible and will result in short-term improvement~     in oxygenation and ventilation. The objective of this proposal is to perform a single-center~     unblinded Phase II randomized clinical trial of aerosolized surfactant for the treatment of~     RDS in preterm neonates undergoing NIV. Funding Source - FDA-OOPD.~   "
97224|NCT02294617|"~     The goal of this study is to get information from current smokers about how they feel towards~     both the electronic cigarette (e-cigarette) and the nicotine oral inhaler. This will include~     beliefs, harms, appeal, ease of use, enjoyment, and their use for helping people stop~     smoking.~   "
97225|NCT02294604|"~     Hand hygiene is the cornerstone of aseptic techniques to reduce surgical site infection. The~     traditional surgical antisepsis involves scrubbing the skin with povidone-iodine or~     chlorhexidine gluconate. Recently, a waterless surgical hand rub formulation containing 61%~     ethyl alcochol, 1% chlorhexidine and moisturizers was developed to provide a comparable~     antiseptic effect. The investigators perform a randomized controlled trial to compare the~     antiseptic effectiveness of the waterless hand rubbing, the classic surgical handwashing with~     povidone-iodine and chlorhexidine solutions.~   "
97226|NCT02294591|"~     This trial investigate add-on treatment with 3 g NAC vs. placebo in 20 weeks in patients~     suffering from bipolar depression. The primary outcome is MADRS-score, and the secondary~     outcomes are other psychometric evaluations oxidative stress biomarkers in urine.~   "
97227|NCT02294578|"~     The investigators plan to recruit patients for a prospective study in patients in need of~     evaluation for lung lesions suspicious for cancer. Saliva samples will be collected before~     diagnostic evaluation including biopsy with subsequent blinded examination of the salivary~     markers without knowledge of the disease status. This prospective recruitment with~     retrospective blinded evaluation or PRoBE design satisfies the highest standards recommended~     by the National Cancer Institute for biomarker development. This process limits the selection~     bias that can confound retrospective studies. As the primary endpoint, a pre-specified~     multi-marker panel will be evaluated based on the combination of sensitivity and specificity.~     In addition, seven pre-specified individual candidate mRNA cancer markers and six internal~     reference or housekeeping genes will be evaluated. The performance of new multi-marker~     panels will also be assessed and compared with the prior pre-specified model based on~     sensitivity and specificity combinations as well as the area under the receiver operating~     characteristic curve.~   "
97228|NCT02294565|"~     The purpose of this Phase 1 portion of this clinical research study is to find out what dose~     of dilute fluorescein is needed for a surgeon to best see important lymph nodes that need to~     be removed during surgery (a standard of care surgery referred to as a Sentinel Lymph Node~     Biopsy procedure) in patients diagnosed with breast cancer.~      The purpose of the Phase 2 portion of this clinical research study is to find out if giving~     dilute fluorescein sodium in combination with a radiotracer (a drug that is radioactive) can~     help surgeons localize the lymph nodes that need to be removed in patients diagnosed by~     breast cancer.~   "
97394|NCT02292407|"~     This study aims at providing first evidence that axillary clearance by using an operation~     technique including the precise LigaSure instrument and closure of dead space of the axilla~     will result in an operation were a drain is not necessary and the need for seroma evacuation~     after surgery is very limited.~   "
97232|NCT02294513|"~     There is a strong connection between hearing loss and cognitive impairment, particularly~     dementia, in old age. Worldwide, dementia affects approximately 5% of persons over the age of~     65 years. Hearing loss is even more prevalent in old age, affecting an estimated one third of~     persons over the age of 65 years. Thus, there is likely a large degree of overlap between the~     impairments. Indeed, this overlap may influence older adults' everyday functioning,~     communication, social engagement and quality of life, as well as influencing the well-being~     of their family caregivers. This project will examine whether patients with hearing loss and~     Alzheimer's disease, the most common form of dementia, derive benefit the from hearing aids~     prescribed and fit to them following current best practice procedures in a geriatric~     audiology clinic. For the first time, a formal evaluation of the potential benefits of~     hearing aids for the patients' family caregivers will also be conducted.~   "
97233|NCT02294500|"~     The study will collect the clinical and biological data of the patients, the investigators~     could further analyse and identify the risk factors and optimize clinical treatment method.~     Besides, population-based healthy people with informed consent are also collected.~   "
97234|NCT02294487|"~     This study will collect blood samples from healthy volunteers and volunteers with multiple~     myeloma who are going to get the seasonal flu, pneumonia, haemophilus influenzae B (HIB),~     and/or meningococcus vaccines.~      The main goal of the study is to start to identify differences in the immune response between~     multiple myeloma patients and people who don't have multiple myeloma. We hope this will~     provide important information about the best way and time to vaccinate multiple myeloma~     patients to flu, pneumonia, haemophilus influenzae B (HIB), and/or meningococcus .~   "
97235|NCT02294474|"~     Primary Objective:~      To demonstrate non-inferiority of SAR342434 versus Humalog in glycated hemoglobin A1c (HbA1c)~     change from baseline to Week 26 in participants with type 2 diabetes mellitus (T2DM) also~     using insulin glargine.~      Secondary Objectives:~      To assess the immunogenicity of SAR342434 and Humalog in terms of positive/negative status~     and antibody titers at baseline and during the course of the study; To assess the~     relationship of anti-insulin antibodies with efficacy and safety. To assess the efficacy of~     SAR342434 and Humalog on: proportion of participants reaching target HbA1c <7.0% and <=6.5%,~     fasting plasma glucose (FPG) and self-measured plasma glucose (SMPG) profiles, and insulin~     dose.~      To assess safety of SAR342434 and Humalog.~   "
97236|NCT02294461|"~     Purpose of the study was to assess the effect of enzalutamide on time to Prostate Specific~     Antigen (PSA) progression as compared to placebo in chemotherapy naïve participants with~     progressive metastatic prostate cancer who have failed androgen deprivation therapy.~   "
97237|NCT02294448|"~     Qishe Pill (Shanghai Sundise Traditional Chinese Medicine Co., Ltd, China), composed of~     processed Radix Astragali, Muscone, Szechuan Lovage Rhizome, Radix Stephaniae Tetrandrae,~     Ovientvine, and Calculus Bovis Artifactus, has been developed and spread in use into clinical~     settings in 2009. As individualization has become the trend of modern medicine, a~     personalized medicine of Qishe Pill should be documented and practiced with various patients~     according to the ancient TCM system, a classification of personalized constitution type,~     which has been established to determine predisposition and prognosis to diseases as well as~     therapy and life-style administration. Therefore, we describe the population pharmacokinetic~     profile of Qishe Pill and compare its extent of metabolism in the 3 major Constitution Type~     (Qi-Deficiency, Yin-Deficiency and Blood-Stasis) to address major challenges of~     individualized and standardized Traditional Chinese Medicine into clinical practice.~   "
97238|NCT02294435|"~     The primary objective of the Visceral Manifold and Unitary Device Study is to assess the use~     of the thoracic bifurcation and the visceral manifold or the unitary device to repair~     thoracoabdominal aortic aneurysms in patients having appropriate anatomy. The primary intent~     of the study is to assess safety and preliminary effectiveness of the device. Additionally,~     the study will assess technical success and treatment success at each follow-up interval.~   "
97239|NCT02294422|"~     This study is aimed at establishing whether use of loss of resistance syringe (LOR) that is~     traditionally used for identifying epidural space, is a better method for providing safe cuff~     pressures in adults intubated with cuffed endotracheal tubes. The conventional method is the~     use of pilot ballon palpation (PBP) to approximate cuff pressures but this is associated with~     airway damage.~      The study hypothesis states that both the loss of resistance syringe method and the pilot~     balloon palpation methods achieve the recommended endotracheal tube intracuff pressures.~   "
97240|NCT02294409|"~     Social anxiety represents one of the most prevalent comorbid conditions in schizophrenia and~     related psychosis. Schizophrenia patients with comorbid social anxiety often exhibit impaired~     social functioning, an increased risk for relapse, and higher rates of suicide. Social~     anxiety is a treatable condition but has, in the context of psychosis, received only scant~     attention thus far. There is strong evidence that cognitive-behavioral therapy (CBT) for the~     treatment of social anxiety is very effective, whether it is delivered individually or in a~     group setting, and studies have shown that a group setting is more effective than individual~     therapy. Providing a CBT intervention for social anxiety represents an effective way to~     empower people with this illness.~      The investigators have conducted a preliminary study using an uncontrolled design to assess~     feasibility and initial benefits of a new manualized group CBT intervention for social~     anxiety specifically adapted for people with psychosis. The investigators observed a~     significant reduction in social anxiety symptoms across three groups of first episode~     psychosis (FEP) participants (n=29) following completion of this 13-week intervention, and~     observed large effect sizes confirming a significant positive influence of this intervention.~     The investigators now propose to conduct a randomized controlled trial to fully assess the~     efficacy of this intervention. The main objective of this research proposal is to contrast~     the impact of a CBT intervention for the treatment of social anxiety in first episode~     psychosis with another control condition involving computer assisted cognitive remediation~     therapy (CACRT). Both interventions will be offered in a group setting, and will therefore~     have the exact same parameters. A secondary objective of this study is to examine the impact~     of reduced social anxiety on measures of clinical and functional outcome.~      For this trial, 120 patients with recent onset psychotic disorder (defined as within 5 years~     from their first episode of psychosis) and with social anxiety will be clinically assessed.~     These participants will be recruited from five different first episode psychosis programs in~     the Montreal area and referred by their treatment team. They will then be randomly assigned~     to either the CBT or CACRT conditions. Both interventions will involve 13 weekly group~     sessions. At the end of group interventions and at two follow-ups (3-month & 6-month), the~     presence and severity of social anxiety symptoms will be assessed. It is hypothesized that~     compared to the CACRT group, individuals receiving the CBT intervention will show a reduction~     in symptoms associated with social anxiety (as determined with multiple self-report and~     clinician rated measures). This effect will be maintained at follow-ups. In addition, the~     investigators also hypothesize that the CBT group will show better clinical outcome, defined~     as the length of symptomatic remission at follow-ups. For functional outcome, they will show~     significant improvement on a self-report measure a clinician-rated measure of recovery. This~     study will be one of the first to specifically target social anxiety in people with psychosis~     using a psychosocial intervention. As such, it will tackle an important problem that is~     interfering with recovery and with the actualization of functional roles.~   "
97241|NCT02294396|"~     The objective of the study is to evaluate the safety and efficacy of add-on therapy with~     anticholinergics in patients with overactive bladder (OAB) on mirabegron.~   "
97244|NCT02294357|"~     The purpose of this Phase II study is to evaluate the safety and effectiveness (good and bad~     effects) of carfilzomib given as a 30-minute infusion and at a dose of 70 mg/m2 to treat~     patients with multiple myeloma (MM), who are currently showing progressive disease~     (worsening) and had progressed (did not respond to treatment) within 8 weeks of receiving~     treatment with twice weekly 27mg/m2 of carfilzomib. Carfilzomib is approved by the U.S. Food~     and Drug Administration (FDA) to be used only in certain U.S. patients with relapsed and~     refractory multiple myeloma that have tried and failed other therapies. Carfilzomib is~     considered an investigational drug for this study because the dose and regimen included in~     this study are different from the FDA approved carfilzomib regimen. Carfilzomib is a type of~     drug called a proteasome inhibitor. Carfilzomib is thought to work by preventing breakdown of~     abnormal proteins in cells, causing the cells to die. Cancer cells are more sensitive to~     these effects than normal cells. Carfilzomib has been previously given to more than 1800~     people in clinical trials.~   "
97245|NCT02294344|"~     The clinical efficacy of double filtration plasmapheresis(DFPP) in patients with~     antineutrophil cytoplasmic autoantibody associated glomerulonephritis(AAGN).~   "
97246|NCT02294331|"~     Lead survivability will be summarized.~   "
97247|NCT02294318|"~     This pilot study goal is to compare two different treatments to help HIV positive patients~     reduce their concurrent drinking and non-injection drug use.~   "
97248|NCT02294305|"~     This placebo-controlled study is designed to determine the efficacy, safety, and tolerability~     of vortioxetine in the treatment of adults with Major Depressive Disorder (MDD) that is~     comorbid with Social Anxiety Disorder (SAD). Half of the subjects will be randomized to~     receive vortioxetine and the other half will receive placebo.~   "
97249|NCT02294292|"~     Cirrhotic cardiomyopathy is defined as a chronic cardiac dysfunction in patients with~     cirrhosis. It is suspected that this specific cardiac dysfunction contributes to the onset of~     complications in liver disease. The purpose of this prospective, randomized controlled trial~     is to determine whether carvedilol can revert cardiac dysfunction i.e. left ventricular~     diastolic dysfunction secondary to cirrhosis, and prevent complications (renal dysfunction,~     worsening cardiac function, and mortality).~   "
97250|NCT02294279|"~     Nitric Oxide is recognized as a biological marker for many chronic airway diseases. It has~     been standardised for clinical use indicating airway inflammation.~      In clinical practice, FeNO can aid confirmation of an asthma diagnosis and can indicate the~     degree of steroid-responsiveness. This can help guide physician decisions on the initiation~     of inhaled corticosteroid (ICS) therapy, or adjustment of ICS therapy.~      Therefore, FeNO measurement could be particularly useful to confirm an asthma diagnosis in~     patients with non-specific respiratory symptoms (≥ 6 weeks of cough and/or wheezing and/or~     chronic dyspnoea) and to assess how likely they are to benefit from corticosteroid treatment.~      This study will assess the suitability of FeNO to predict ICS responsiveness in patients with~     non-specific respiratory symptoms.~      Additionally, we would like to determine the suitability of FeNO as a diagnostic tool for~     asthma in comparison to conventional predictors, e.g. spirometry.~   "
97251|NCT02294266|"~     The purposes of this study are 1) to evaluate the pharmacological effects after oral~     coadministration of mephedrone and alcohol and 2) determine the pharmacokinetics changes of~     mephedrone and alcohol concentrations after oral coadministration of mephedrone and alcohol.~   "
97252|NCT02294253|"~     The investigators will randomize 50 opioid-dependent participants who have initially failed~     outpatient induction onto XR-NTX; participants will receive buprenorphine/naloxone on a~     weekly basis for 30 days. Buprenorphine/naloxone will be dispensed weekly during the 30-day~     stabilization and twice weekly during taper phase, and all patients who successfully complete~     the detoxification will be offered induction onto XR-NTX. All participants will receive~     weekly therapy with a study psychiatrist. All participants will receive open-label~     medication. The primary outcome of this study will be percentage of patients successfully~     inducted onto XR-NTX. Secondary outcomes will be time to relapse, defined as opioid use or~     dropout.~   "
97253|NCT02294240|"~     A nutrition trial which is based on the evidence that multivitamins & micro nutrients~     provided during pregnancy in malnourished women will improve neonatal birth weight. There~     will be two arms. Arm one will provide energy dense biscuits to pregnant women with BMI <20 &~     gestational age less than 14 weeks. The other arm with same criteria will be provided with~     wheat flour, oil, iron & folic acid. Neonatal birth weight is the primary outcome of interest~     but maternal weight gain, maternal hemoglobin & ferritin levels and palatability of biscuits~     will also be assessed.~   "
97254|NCT02294227|"~     The purpose of this study is to provide 16-week efficacy, safety and tolerability data versus~     placebo to support the use of secukinumab 150 mg by subcutaneous (s.c.) self-administration~     with or without a loading regimen and maintenance dosing using pre-filled syringe (PFS) and~     to assess efficacy, safety and tolerability up to 2 years in subjects with active AS despite~     current or previous NSAID, non-biologic DMARD or biologic anti-TNFα therapy~   "
97255|NCT02294214|"~     The primary objective of the study is to demonstrate and quantify the protective efficacy~     (PE) of spatial repellent products in reducing the incidence of malaria infection in human~     cohorts. The null hypothesis (H0) is that there is no difference in malaria incidence between~     intervention and control arms.~   "
97256|NCT02294201|"~     The primary objective of the study is to demonstrate and quantify the protective efficacy~     (PE) of spatial repellent products in reducing the incidence of malaria infection in human~     cohorts. The null hypothesis (H0) is that there is no difference in malaria incidence between~     intervention and control arms.~   "
97257|NCT02294188|"~     The primary objective of the study is to demonstrate and quantify the protective efficacy~     (PE) of spatial repellent products in reducing the incidence of malaria infection in human~     cohorts. The null hypothesis (H0) is that there is no difference in malaria incidence between~     intervention and control arms.~   "
97258|NCT02294175|"~     This is a prospective study of Veterans with chronic lower extremity or diabetic foot ulcers~     who will be randomized to either a Larval Debridement Therapy group (Biobags every 4 days x 2~     applications) or a Sharp Debridement Therapy group (standard or control weekly x 2) during an~     8 day study period.~   "
97259|NCT02294162|"~     Pain is an unpleasant sensory experience associated with actual or potential tissue damage.~     Acute pain management is an important aspect of perioperative anesthetic care. Moreover, it~     is the most important factor related to patient discomfort after surgery. Adequate pain~     management, ideally resulting in the complete absence of postoperative pain, not only~     provides comfort to patients, but may also contribute to improved healing and a reduction in~     the incidence of postoperative complications. Inadequate postoperative analgesia has been~     shown to contribute to adverse outcomes, including, but not limited to, immunosuppression,~     hyperglycemia, poor rehabilitation, and progression to chronic pain.~   "
97260|NCT02294149|"~     The purpose of this study is to determine whether administration of mammalian Omega 3~     FA(fatty acid) with Vitamin D3 supplements would lower or prevent the risk of neuropathy due~     to chemotherapy.~   "
97261|NCT02294136|"~     End-stage liver disease, predominantly due to hepatitis C virus (HCV) infection, is one of~     the leading causes of death in person living with HIV infection. While HCV is curable and~     recent advances in treatment have increased the rates of cure, few patients with HIV and HCV~     are being treated to cure HCV. Based on formative research, the investigators developed the~     Psychosocial Readiness Evaluation and Preparation for hepatitis C treatment (PREP-C).~     PREP-C is a clinical interview that healthcare providers of diverse disciplines can be~     trained to administer. It provides an assessment of a client's psychosocial readiness to~     begin HCV treatment and identifies domains of functioning which require intervention to~     improve treatment readiness. PREP-C (www.prepC.org) is also a telemedicine resource for~     health care providers. Under this protocol, the existing PREP-C clinical interview (or~     assessment) is incorporated with a behavioral intervention. This study tests the integrated~     assessment-behavioral intervention to increase HCV treatment initiation among HIV-co-infected~     patients. The assessment-behavioral intervention under this protocol is conducted in two~     phases, an Intervention Development phase and a Pilot Randomized Clinical Trial (RCT) phase.~      Findings from this vanguard study will inform the design parameters of a larger, more~     rigorous evaluation in an R01 application, if results are promising. The PREP-C web-based~     assessment and intervention package is designed to be scalable and can be disseminated~     through the live PrepC.org web site. The proposed study is innovative in that it seeks to~     develop the first web-based intervention for health care providers to use to increase HCV~     treatment initiation in HIV/HCV-co-infected persons. The study can have a major public health~     impact by providing needed structured resources for health care providers to increase rates~     of HCV treatment initiation in HIV/HCV-co-infected persons, thereby reducing mortality due to~     end-stage liver disease.~   "
97262|NCT02294123|"~     Objective. To evaluate the effect of the intake of two types of whole corn tortilla and one~     traditional tortilla on glycemic index (GI) and insulinemic index (InIn) in adults with~     diabetes, or overweight or clinically healthy.~      Material and methods. Type crossover clinical trial in adults 20-69 years. Three groups of~     participants will be included for each category (n = 27 in each group): 1) adults with~     diabetes, b) adults with overweight c) clinically healthy adults. The glycemic and~     insulinemic index will be measure for each group of participants given in random order the~     following foods: 1) a whole corn tortilla (white criollo corn= 5.3% fiber), 2) a whole corn~     tortilla (white hybrid corn= 7.9%), 3) a traditional corn tortilla (3.9% fiber), and 4)~     white bread (reference food containing 2.2% of fiber). For the calculation of GI and InIn~     will be follow the FAO methodology. For the evaluation of each food left the range of 1~     week.~   "
97263|NCT02294110|"~     Some of the authors says that diabetes mellitus is a risk factor for spinal anesthesia~     failure. However, that opinion was not determined in a trial. Thus the investigators aimed to~     investigate the effect of diabetes mellitus on spinal anesthesia.~   "
97264|NCT02294097|"~     The risk-benefit of surveillance-protocol biopsy (SPBx) in kidney transplantation remains~     unclear. The study aims to compare outcomes of recipients with SPBx approach to recipients~     with standard approach which allograft biopsy was performed only when indicated.~   "
97265|NCT02294084|"~     The obesity epidemic has resulted in an exponential increase in obesity-related disorders~     including type 2 diabetes, dyslipidemia and cardiovascular disease. The associated morbidity~     and mortality have major consequences both at an individual as well as on the socioeconomical~     level. Thus, the development of novel therapies aimed at reducing the development of obesity~     is highly warranted. Brown adipose tissue (BAT) recently emerged as a novel player in energy~     expenditure in humans as it combusts fatty acids towards heat. Interestingly, obese subjects~     have less BAT as compared to lean subjects and activation of BAT by means of intermittent~     cold exposure reduces fat mass. Therefore, BAT is considered a promising novel target to~     reduce obesity and associated disorders. As cold exposure is not the most desired therapeutic~     strategy for humans, current pre-clinical research focuses on pharmacological activation of~     BAT.~      Interestingly, the investigators have recently shown that central agonism of the receptor for~     the incretin hormone glucacon-like peptide-1 (GLP-1) results in activation of BAT in mice.~     One of the currently used anti-diabetic drugs that enhances GLP-1 availability is Sitagliptin~     (STG). Interestingly, STG also reduces body weight and plasma triglyceride (TG) levels in~     type 2 diabetes mellitus (T2DM) patients. The mechanism underlying these beneficial metabolic~     effects is currently unknown. The investigators hypothesize that STG enhances BAT activation,~     thereby increasing energy expenditure and combustion of TG-derived fatty acids, resulting in~     lowering of plasma TG levels and body weight.~      To this end, the investigators will perform a randomized double-blinded placebo-controlled~     study in which 30 male Dutch Caucasian adults aged 35-50 years with moderate obesity and~     pre-diabetes are included. Subjects will be treated for 12 weeks with STG or placebo. Before~     and after treatment, the investigators will determine BAT volume and total BAT activity via~     cold-induced 18F-FDG PET-CT scans, resting energy expenditure via indirect calorimetry using~     ventilated hoods, body weight, and body composition via DEXA scan. Furthermore, before and~     after treatment, blood samples will be taken to measure plasma lipids, glucose and insulin~     levels.~      This study will offer valuable novel insight in the effects of pharmacological activation of~     BAT in human obese subjects.~   "
97266|NCT02294071|"~     This study will examine in detail the immediate effects of three common treatments given to~     children with fevers to lower their temperature. Each child will be given either ibuprofen,~     acetaminophen, or a combination, and their temperature monitored at five-minute intervals.~     The temperature-lowering effects of each treatment will be compared to evaluate which is most~     effective.~   "
97267|NCT02294058|"~     The purpose of this study is to determine whether RPC1063 is effective in the treatment of~     relapsing multiple sclerosis (RMS).~   "
97268|NCT02294045|"~     Clinical-noninvasive recording of sounds from the knees through a brief loaded range of~     motion. Description in phase 1 analytic but descriptive as well in phase 2. No samples other~     than a sound recording. The device is known microphone attached to the skin of the knee with~     elastic material. Sound recorded and analyzed on a lap top computer with Adobe software.~   "
97269|NCT02294032|"~     The purpose of this study is to understand the role of specific B cells in activating or~     repressing an anti-allograft immune response after kidney transplantation. In this study,~     blood will be collected from kidney transplant patients during different timepoints, prior to~     and after their transplant. Knowledge gained from study findings will be used to develop~     therapeutic strategies to prevent antibody-mediated rejection, which is a major cause of~     long-term graft loss in kidney transplant patients.~   "
97270|NCT02294019|"~     This is an open label, multicenter, 30 day study designed to mimic an OTC like environment in~     which subjects will use the product after making a purchase decision about ibuprofen 400 mg~     caplets based only on their reading of the Drug Facts Label (DFL) and other information on~     the package.~   "
97271|NCT02294006|"~     Abnormal PI3K-Akt-mTOR (mammalian target of rapamycin) pathway signaling and autocrine~     activation of the mTOR pathway, mediated through insulin-like growth factor 1 (IGF1), has~     been implicated in the proliferation of pNET ( primitive neuroectodermal tumor) cells.~     Everolimus ,an mTOR inhibitor (a central regulator of growth/proliferation, cellular~     metabolism and angiogenesis) has shown antitumor benefit in pNETs alone and in combination~     with Octreotide LAR in RADIANT-1 and RADIANT-3 studies.~      Despite EVE-based phase II/III trials improve progression-free survival (PFS) for pNETs, they~     are limited to significantly prolong overall survival (OS). Metformin has recently shown some~     anti-cancer activity, both in vitro and in vivo studies by antisecretory properties to~     decrease insulin and IGF1 levels; and by antitumor effect due to AMPK (adenosine~     monophosphate kinase) activation and consequently inhibition to TSC1(tuberous sclerosis~     complex 1) -2/mTOR complex, mediated to LKB1 oncogene expression. The investigators~     retrospective experience, despite in a limited group of pWDNET, highlights the role of MET to~     improve clinical benefit in diabetic pts receiving EVE-OCT (octreotide) combination.~      This study will investigate the antiproliferative potential of MET in combination with EVE~     and OCT in pWDNETs. MetNET1 prospective trial (EudraCT 2014-000888-41) may be helpful to~     either confirm or discard these preliminary findings.~      The main objective of this study is to evaluate progression free survival rate at 12 months~     of treatment. The secondary objectives are safety, overall survival, response rate~     evaluation.~      A sub-study analysis will evaluate circulant biomarkers levels (IL 6, IGF1) in blood samples.~   "
97272|NCT02293993|"~     To evaluate the tolerability and pharmacokinetics of SGI-110 when administered subcutaneously~     to Japanese patients with acute myeloid leukemia (AML).~   "
97273|NCT02293980|"~     PART 1: The primary objective of this study is to identify the maximum tolerated dose (MTD)~     of PT2385 Tablets and/or the recommended Phase 2 dose (RP2D) of PT2385 Tablets in patients~     with advanced clear cell renal cell carcinoma (ccRCC).~      PART 2: The primary objective of this study is to identify the MTD of PT2385 Tablets up to~     the RP2D, in combination with nivolumab, in patients with advanced ccRCC.~      PART 3: The primary objective of this study is to identify the MTD of PT2385 Tablets up to~     the RP2D, in combination with cabozantinib tablets, in patients with advanced ccRCC.~   "
97274|NCT02293967|"~     The purpose of this study is to investigate the absorption, metabolism and excretion of~     MT-1303 in healthy subjects.~   "
97275|NCT02293954|"~     This pilot clinical trial studies copper Cu 64 anti-carcinoembryonic antigen (CEA) monoclonal~     antibody M5A positron emission tomography (PET) in diagnosing patients with CEA positive~     cancer. Diagnostic procedures, such as copper Cu 64 anti-CEA monoclonal antibody M5A PET, may~     help find and diagnose CEA positive cancer that may not be detected by standard diagnostic~     methods.~   "
97276|NCT02293941|"~     The primary objective of this study is to assess changes in alanine aminotransferase (ALT) in~     hepatitis C virus (HCV)-infected subjects given daily doses of JKB-122 for 3 months who have~     been nonresponsive to, intolerable to, or relapsed from prior interferon-based therapies~     (pegylated or standard) either alone or in combination with ribavirin or other anti-HCV~     therapies including direct-acting anti-viral agents.~   "
97277|NCT02293928|"~     The effect of antiplatelet therapy is impaired among patients, who recently underwent on-pump~     coronary artery bypass grafting. The impact of hybrid coronary revascularization using~     minimal invasive surgical techniques on the antiplatelet effect of aspirin and clopidogrel~     remains unclear.~      The aim of the study is to describe the impact of hybrid coronary revascularization on the~     effect of aspirin and clopidogrel. Furthermore, we will investigate whether high baseline~     platelet aggregation, high postoperative levels of platelet turnover and acute-phase response~     may contribute to the effect.~   "
97278|NCT02293915|"~     The primary purpose of this study is to determine the efficacy and safety of Sodium~     Oligo-mannurarate (GV-971) in 36-week treatment of mild to moderate Alzheimer's disease.~   "
97279|NCT02293902|"~     Primary Objective:~      -To demonstrate that sarilumab added to methotrexate (MTX) reduce signs and symptoms of~     rheumatoid arthritis (RA) in Japanese RA participants with an inadequate response to MTX.~      Secondary Objective:~      -To assess the safety of sarilumab added to MTX in Japanese RA participants with an~     inadequate response to MTX.~   "
97280|NCT02293889|"~     Knee Osteoarthritis (KOA) is a major cause of pain and disability, particularly in those of~     increasing age and body fat. As there are no very effective therapies for KOA, disease often~     progresses until knee replacement surgery is needed. It has been observed Vitamin D and~     Physical Activity (PA) levels are lower in those with KOA, increased age and body fat. As the~     relationship between KOA, Vitamin D and PA levels are not clearly understood, this study aims~     to explore these relationships and the acceptability/feasibility of PA and Vitamin D~     interventions in those who would likely to benefit from these interventions.~      200-300 people, 50-70 years, BMI 30-40kg/m2, meeting American College of Rheumatology (ACR)~     KOA Guidelines, will be recruited from North Tyneside and Liverpool Hospital trusts November~     2014-January 2016 to participate in a single cross-sectional study visit, which will measure:~     Vitamin D/Calcium serum levels, BMI/Body Fat, mobility, Quality of life and pain (by~     questionnaire), and PA levels.~      Those participants with insufficient Vitamin D levels (25-50nmol/L) and PA levels (<30min~     moderate PA/week), will be invited to take part in a 3 month pilot RCT study.~      >64 people will be recruited for the pilot RCT and equally randomly allocated to 1 of 4~     intervention groups: Vitamin D (1 capsule a day: 2000IU), Placebo (identical capsule: 1 a~     day), PA (online PA programme) and PA and Vitamin D. Additionally at the end of the 12 week~     study visit, up to 20 participants will be invited to take part in a qualitative interview~     exploring their experience during the two studies.~   "
97281|NCT02293876|"~     The purpose of the study is find out the better measure to achieve corneal protection in an~     Intensive Care Unit.~   "
97282|NCT02293863|"~     This is a randomized, double-blind, placebo-controlled study that will investigate the safety~     and clinical activity of a single intravenous (IV) dose of MHAA4549A in adult participants~     hospitalized with severe influenza A in combination with oseltamivir versus a comparator arm~     of placebo with oseltamivir.~   "
97498|NCT02291055|"~     Part A: (ADXS11-001 + MEDI4736 Combination Therapy) will determine the safety and~     tolerability of the combination and to identify a RP2D.~      Part B:~      Phase 2 design which will randomize subjects 1:1 to either MEDI4736 alone or~     MEDI4736+ADXS11-001 in subjects who have failed at least 1 prior systemic treatment for their~     recurrent/persistent or metastatic cervical cancer.~   "
97284|NCT02293837|"~     Type 1 diabetes mellitus (T1DM) is an autoimmune disease. Based on previous research, study~     doctors think that giving medicines to affect the immune system soon after diabetes is~     diagnosed may stop, delay or decrease the destruction of beta cells, resulting in better~     glucose control.~      Researchers believe that tocilizumab could have some effect on the cells in the immune system~     that are thought to be involved in the development of type 1 diabetes. This study will test~     whether tocilizumab can help preserve or delay destruction of remaining beta cells in people~     recently diagnosed type 1 diabetes.~   "
97285|NCT02293824|"~     Almost all infants born <29 weeks gestational age develop apnea of prematurity and are~     treated with caffeine. Type of diet and disease states may be significant contributors of~     variability in caffeine metabolism and pharmacokinetics (PK) in this population. This~     prospective, observational, open-label, opportunistic PK study will compare the population PK~     of caffeine between infants fed formula and infants fed exclusively breast milk; compare the~     activities of caffeine metabolizing enzymes between infants fed formula and infants fed~     exclusively breast milk; and determine the effect of hypoxia, hypotension, and infection on~     caffeine PK and metabolism in premature infants.~   "
97286|NCT02293811|"~     The inflammatory tumor micro-environment is a consequence and a driver of tumorogenesis. On~     one hand it promotes antitumor immune responses and on the other hand it favors development~     and progression of cancerous lesions.~      Factors regulating the complex interplay between epithelial and immune cells are still poorly~     characterized. Extracellular ATP (eATP) acting on the purinergic P2X7 receptors (P2RX7) has~     recently emerged as a key signaling pathway in the immune response.~      Recent data have revealed the crucial role of P2RX7-NLRP3-Caspase-1 for priming dendritic~     cells (DC) within the tumor microenvironment upon treatment with certain types of~     chemotherapy drugs. Despite this important discovery, no previous study has so far~     investigated the global in vivo effect of P2RX7 modulation in inflammation-induced~     carcinogenesis of mucosal tissues.~      Our consortium, endowed by a long standing experience in the field of mucosal immunology,~     inflammation and signaling, already demonstrated that the P2RX7 is differentially expressed~     in the mucosa of patients with active and quiescent inflammatory bowel disease (IBD), where~     eATP is present at very high concentration, and that P2RX7 controls an amplification loop of~     the inflammatory response (Cesaro et al., 2010). Furthermore, we uncovered that P2RX7~     controls homeostasis, survival and function of regulatory T cells (Hubert et al., 2010). In~     addition, our recent demonstration that P2RX7 deficiency lowered mucosal inflammation but~     unexpectedly enhanced tumor formation in vivo warrants additional efforts to explore the~     molecular and cellular mechanisms accounting for this effect and suggest that enhancing P2RX7~     function may have an anti-tumor therapeutic effect.~      These observations emphasize the tumor suppressor role of P2X7 receptor, warrant further~     investigation to better understand the molecular mechanisms responsible for this anti-tumor~     effect and suggest that enhancing the function of P2X7R could have a therapeutic effect~     significant antitumor.~      Our main objectives is to explore the role of P2RX7 in healthy, inflammatory and cancerous~     colonic mucosa. For this we will map the expression of the protein P2RX7 and realize genotype~     of P2RX7 forms in inflammatory diseases and cancer of the colon.~   "
97287|NCT02293798|"~     The purpose of this study is to evaluate the clinical performance of SERI® Surgical Scaffold~     to maintain the size of the areola by providing additional soft tissue support after~     circumferential periareolar mastopexy.~   "
97288|NCT02293785|"~     The symptoms associated in advanced cancer patients and adverse events due to use of opioids~     have major influence on the state of health and quality of life of patients. The pain, in~     particular, is a symptom with severe negative impact and with a prevalence ranging between~     33% and 64%, according to the stage of the disease, with values around 70-90% in advanced~     stages and metastatic.~      The use of opioids, however, is usually associated with the appearance of common adverse~     events as drowsiness/sedation, constipation, nausea/vomiting, and dizziness. Some effects are~     self-limiting in the time for the appearance of tolerance while others, as constipation~     persist.~      Several clinical studies have demonstrated that the association oxycodone-naloxone (OXN),~     which consists in the union between a molecule agonist and an antagonist of opioid receptors,~     reduced the constipation in the presence of unchanged analgesic efficacy compared to~     oxycodone alone.~   "
97289|NCT02293772|"~     A loss of body weight has been documented in lowland-living individuals when exposed to~     hypoxic environments, such as at high altitude, or under laboratory conditions. A reduction~     in appetite and energy intake has also been reported during conditions of microgravity, such~     as during space flight. Fourteen normal or over-weight men, who are otherwise healthy, will~     undergo 3x 21-day interventions; normobaric normoxic bed rest (NBR; FiO2=21%), normobaric~     hypoxic ambulatory confinement (HAMB; FiO2=14%; ~4000 m simulated altitude), and normobaric~     hypoxic bed rest (HBR; FiO2=14%). The effects of hypoxia and bedrest on appetite and its~     hormonal control will be assessed before and at day 17 of each intervention using a mixed~     meal tolerance test.~   "
97290|NCT02293759|"~     Patients presented for BPH surgery at our out patient clinic will be assessed for abnormal~     bleeding profile.~      Patients with bleeding tendency will be offered either HoLEP or Greenlight laser PVP based on~     prostate size cut off point of 80ml Larger prostates will be treated with HoLEP Smaller~     prostates will be treated with greenlight PVP~   "
97291|NCT02293746|"~     The purpose of this study is to obtain additional safety and efficacy data on the use of~     Inspire® therapy for the treatment of subjects with moderate to severe Obstructive Sleep~     Apnea.~   "
97292|NCT02293733|"~     The purpose of our retrospective study is to describe which circumstances EGFR TKI is~     continued despite progression according to the usual Response Evaluation CrIteria in Solid~     Tumours (RECIST) in patients with EGFR activating mutations and acquired resistance to EGFR~     TKI .We will collect their social and demographic data (age, sex), first Progression Free~     Survival ( PFS) - from start of EGFR TKI to 1st progression PFS 1- and - from first~     progression according to RECIST to second progression : PFS2- , Overall Survival (OS) - from~     diagnosis OS 1 and from first progression OS 2 -, mutational status. We will analyze more~     closely the mode of progression (site), the therapeutic approach at disease progression. We~     will define two subgroups: those for whom EGFR TKI was continued at least three months~     despite progression defined according to RECIST criteria, and those for whom a second-line~     treatment (chemotherapy without EGFR TKI) was chosen at disease progression. It will be~     individualized the subgroup of patients in whom it was continued TKI after progression.~   "
97293|NCT02293720|"~     A multi-center, single-arm, open-label study to evaluate the safety and effectiveness of the~     EndoBarrier Gastrointestinal Liner System liner on glycemic control in control subjects from~     study #09-1 who are not treatment failures and have completed 12 months of the study.~   "
97499|NCT02291042|"~     This study evaluates the ability of a belladonna and opium suppository given prior to surgery~     to improve bladder comfort after surgery for patients who are having elective ureteroscopy~     surgery.~   "
97500|NCT02291029|"~     This study will evaluate the safety,tolerability and preliminary therapeutic efficacy of~     multiple doses of intravenous infusion of CFZ533 monoclonal antibody in patients with primary~     Sjögren's syndrome(pSS)~   "
97294|NCT02293707|"~     GX301 is an experimental therapeutic vaccine directed against human telomerase, an enzyme~     playing an essential role in cancer cell proliferation.~      This clinical trial will test three different GX301 administration regimens in~     castration-resistant prostate cancer patients who have achieved response or disease stability~     with first-line docetaxel treatment. This is aimed at identifying an optimal vaccination~     regimen.~      The three regimens will primarily be compared for their efficacy and safety in inducing~     vaccine-specific immunological responses over a period of 6 months following treatment~     initiation. In addition, patients will be observed for the occurrence of disease progression~     and for their vital status up to 24 months.~   "
97295|NCT02293694|"~     The feasibility of Sayana Press self-injection and the potential for this practice to~     increase contraceptive continuation has never been assessed in family planning programs in~     low-resource settings. The Malawi Ministry of Health (MOH) and the United States Agency for~     International Development (USAID) Malawi Mission requested the Advancing Partners and~     Communities (APC) project to assess self-injection of Sayana Press to inform their~     decision-making for procurement of Sayana Press and distribution through the health system in~     Malawi.~   "
97296|NCT02293681|"~     The purpose of this observational (a study that follows participants forward in time) study~     is to compare the functional improvement of hip joint using Harris hip score between 2~     treatment groups (infliximab and conventional therapy) at Week 30 in ankylosing spondylitis~     (an autoimmune disease causing chronic inflammation at tendon ends and ligament attachment~     points) participants with hip involvement.~   "
97297|NCT02293668|"~     There are different controlled ovarian hyperstimulation protocols utilized in infertility~     patients. In this study, our aim is to specifically compare three protocols in poor~     responding infertility patients.~   "
97298|NCT02293655|"~     This study evaluates the effects of receiving and then discontinuing methylphenidate (MPH) in~     children with ADHD. After receiving MPH for 8 weeks, participants will be randomized to~     either discontinue MPH (and receive placebo) OR remain on MPH for 4 weeks.~   "
97299|NCT02293642|"~     Translation and validation of the BOMET-QoL-10 questionnaire in Germany and assessment of its~     validity and responsiveness.~   "
97300|NCT02293629|"~     This is the first clinical study with the BMS-986147 compound in healthy subjects. The~     purpose of this study is to guide the dose range and dose frequency for future studies with~     BMS-986147 and will provide guidelines for selection of a potentially effective dose in~     patients.~   "
97301|NCT02293616|"~     It is well documented that intensive care unit (ICU) patients have lower levels of skeletal~     muscle strength compared to non-ICU patients upon hospital discharge, and this weakness~     affects the patient's ability to perform basic activities of daily living upon hospital~     discharge and for extended periods thereafter. Recently, critically ill ICU patients have~     been shown to have lower nitric oxide levels. These patients often suffer from a disturbed~     homeostasis with circulatory and metabolic abnormalities that may potentially contribute to~     their ICU acquired weakness. Given the recent research showing dietary nitrate~     supplementation can increase nitric oxide levels and improve exercise tolerance in healthy~     and diseased older individuals, our aim is to investigate the importance of nitrate~     supplementation in ICU patients with focus on physical function and ICU acquired muscle~     weakness.~   "
97302|NCT02293603|"~     To determine the safety profile of CAP-1002 administered by multi-vessel intracoronary~     infusion in subjects with DCM. The study will further explore safety and exploratory efficacy~     endpoints of CAP-1002.~   "
97303|NCT02293590|"~     Tight control of an adaptive concomitant treatment strategy after initiation of CZP will lead~     to an improved outcome of RA patients with an active disease despite DMARD treatment.~   "
97304|NCT02293577|"~     The purpose of this study is to use a continuous glucose monitor (CGM) to describe the day to~     day blood glucose variability in youth with type 2 diabetes. The hypothesis is that CGM will~     identify caloric and exercise related variation in blood glucose that is not identified by~     the subjects' current regimen of intermittent finger stick blood glucose measurements.~   "
97305|NCT02293564|"~     The purpose of this study is to evaluate the long-term safety of gevokizumab in the treatment~     of active inflammatory, erosive osteoarthritis of the hand.~   "
97306|NCT02293551|"~     The purposes of this study are to determine:~        -  Part A~             -  How quickly your body absorbs, breaks down and gets rid of the different~               formulations of insulin lispro compared to insulin lispro alone formulation.~             -  The safety of insulin lispro in different formulations and any side effects that~               might be associated with it.~        -  Part B:~             -  How much insulin lispro from different dose ranges is found in the bloodstream~               using a test insulin lispro formulation (selected from Part A).~             -  The safety of insulin lispro in different formulations and any side effects that~               might be associated with it.~      Participants may only enroll in one part. The study is expected to last up to 10 weeks for~     each part.~   "
97307|NCT02293538|"~     The purpose of this study is to evaluate the thickness of the pre-lens tear lipid layer after~     2 hours of lens wear with use of FID 114657 compared to saline control.~   "
97308|NCT02293525|"~     The purpose of this study is to evaluate the clinical performance of the ReLeaf infusion~     catheter & wound drain in patients following lumbar spinal fusion surgery. One half of the~     patients will receive continuous local analgesic fusion during the post-operative period~     while the other half will received continuous local saline.~   "
97309|NCT02293512|"~     Tinnitus (i.e., ringing in the ears) is currently the most prevalent disability among~     Veterans. A range of clinical interventions has been created to systematically address the~     range of issues caused by tinnitus. While numerous interventions purport to promote coping~     strategies for tinnitus-related problems, few studies directly target and measure coping~     outcomes. The present pilot study proposes a comparison of coping outcomes after 3~     psycho-educational groups: a cognitive-behavioral therapy (CBT) intervention, a Coping~     Effectiveness Training (CET) intervention, or an Acceptance and Commitment Therapy~     intervention among Veterans with tinnitus. These groups will be compared to a usual care~     group among Veterans and civilians with tinnitus. The proposed study will be the first~     application of CET to tinnitus. The primary goals of this study are to develop a CET protocol~     for tinnitus and to evaluate the effectiveness of CBT, CET, and ACT interventions to a usual~     care group. The long-term goal of this study is to improve the quality of life among~     individuals with tinnitus.~   "
97310|NCT02293499|"~     Asthma is a serious chronic health condition particularly in inner-city adolescents, who~     suffer disproportionately high asthma-related morbidity and mortality that place heavy~     economic burdens on families and society. There is a consensus that adverse asthma outcomes~     can be ameliorated by an individual's active engagement in adequate self-management. This~     multi-site randomized controlled study proposes to implement and evaluate a peer-led asthma~     self-management for adolescents (PLASMA) program that has demonstrated its feasibility and~     preliminary efficacy in a previous study. PLASMA will be implemented in three cities (Buffalo~     NY, Baltimore MD, and Memphis TN) that have particularly high rates of pediatric asthma and~     asthma-related morbidity, and are thus most likely to benefit from the program. PLASMA~     comprises three main components: (a) peer-leader training; (b) a one-day asthma camp where~     peer leaders will deliver manualized self-management content recommended by the national~     guidelines; and (c) bi-monthly peer-leader contacts. Specific aims are: (1) to evaluate the~     effectiveness of PLASMA in inner-city adolescents with asthma in improving quality of life~     (primary outcome), and asthma knowledge, attitudes, outcome expectations, self-efficacy,~     self-management skills, and asthma control, FEV1 (exploratory outcomes) over time, compared~     to a control group for whom adult leaders will deliver the same program content; (2) to~     examine the mediating effects of the exploratory outcomes on quality of life; (3) to examine~     the moderating effects of personal factors (e.g., age, sex, family support) on the~     intervention's primary and exploratory outcomes; (4) to evaluate the effects of PLASMA on~     study outcomes in peer leaders (16-20 years); and (5) to determine the economic impact of the~     intervention. These aims will be accomplished using a two-group randomized controlled trial~     with 378 adolescents (12-17 years) from the three cities (126 for each site). A total of 42~     qualified peer leaders (14 in each site) will be enrolled based on adult nomination.~     Eligibility criteria for both peer leaders and adolescent learners include: a current asthma~     diagnosis; persistent asthma; absence of other chronic or mental illness; inner-city~     residence; and capability of verbal and written communication in English. Participants will~     provide data at enrollment (T1), camp (T2), and at 3-, 6-, 9-, 12-, and 15-months post-camp~     (T3-T7). Data will be analyzed using a multi-site hierarchical three-level linear~     mixed-effects model where level 1 represents repeated measures, level 2 = subject, and level~     3 = site. To determine the economic impact of the program, investigator will measure the~     direct healthcare costs and total costs of the program, and perform net cost analyses for~     each type of costs. In addition, investigator will estimate cost-effectiveness ratios of the~     PLASMA group compared with the control.~   "
97311|NCT02293486|"~     The purpose of this study is to evaluate modifications of plasma protein carbonyls and~     malondialdehyde levels in endurance-based athletes after three weeks of pomegranate juice~     consumption.~   "
97312|NCT02293473|"~     This study is designed to test if measuring the depth of anaesthesia, brain tissue~     oxygenation and haemodynamic parameters and specially designed interventions according to the~     measurements can improve the outcome of high risk surgical patients undergoing major~     abdominal surgery.~   "
97313|NCT02293460|"~     Primary objective:~      To assess the efficacy of I10E in improving the disability of patients with CIDP.~      Secondary objective:~      To assess the safety of I10E in patients with CIDP.~   "
97314|NCT02293447|"~     Uterine artery embolization (UAE) is a minimally invasive treatment for women with~     symptomatic fibroids. It is similar to hysterectomy in term of satisfaction and symptoms~     improvement, with fewer complications and at lower cost. However, the majority of women~     undergoing UFE experience important pain after the procedure despite optimal analgesia, with~     one third reporting pain equal or worse than labor. Pain is the more common cause of~     prolonged hospital stay or readmission. There is need for a simple, efficient way to reduce~     post-procedural pain.~      For this prospective randomized study, the hypothesis is that an anesthetic drug, lidocaine,~     injected in the uterine arteries diminishes pain post-UFE. Patients will be randomized in 3~     groups: control, lidocaine injected during embolization, and lidocaine injected after~     embolization. Pain will be evaluated using a validated scale at 4h and 24h post-intervention.~     Hospital length-of-stay and total narcotic dose administered will be evaluated in the three~     groups.~      This is the first Canadian study evaluating lidocaine use for pain control in UFE patients.~     Results will be transferable to clinical practice, considering the use of lidocaine is simple~     and cost is negligible. It could have a great impact on pain management in women undergoing~     UFE in all practice settings.~   "
97315|NCT02293434|"~     Study rationale: Children admitted to intensive care are often chronically ill and the~     intensive care setting may upset the balance between nutritional intakes and needs.~      As malnutrition is a key factor in the morbidity/mortality on pediatric intensive care units~     (PICUs), screening for malnutrition and the individualized adaptation of nutritional support~     are important elements of patient care. Yet no recent study has evaluated the nutritional~     status of children admitted to PICUs in France.~      Primary Objective: Determine the prevalence of malnutrition in the population of children~     admitted to intensive care.~      Secondary objectives:~        -  Determine the children's nutritional status on admission.~        -  Characterize the profile of malnourished patients compared with those not malnourished~          (sex, age, history, chronic disease, usual dietary habits, reason for admission,~          scheduled/unscheduled admission, surgery/medication, seriousness, seasonality).~        -  Describe the practices regarding nutritional care in each center.~      Population: All children (1 month to 18 years) admitted to all PICUs in France during three~     one-week periods (February, June, October) in the course of a year.~   "
97316|NCT02293421|"~     Although obstructive sleep apnea (OSA) is common, most of the patients are undiagnosed. OSA~     is associated with a large number of co-morbidities, and thus, it is of great importance to~     identify the patients and start treatment in order to reduce the risks for complications.~     Current screening tools are quite unspecific and the golden standard methodology for~     diagnosis, polysomnography, is expensive and time consuming, thus not suitable for screening.~     In perioperative medicine the STOP BANG screening questionnaire is currently the recomended~     screening tool, however this questionnaire has only been evaluated in a sleep clinic in a~     very limited numbers of patients.~   "
97317|NCT02293408|"~     The objectives of this study are to describe the clinical and biochemical characteristics and~     course of disease progression in patients with MPS IIIB~   "
97318|NCT02293395|"~     The purpose of this study is to estimate the risk of bleeding with rivaroxaban, compared with~     acetylsalicylic acid (ASA), in addition to a single antiplatelet/ platelet adenosine~     diphosphate P2Y12 receptor antagonist (P2Y12 inhibitor agent: clopidogrel or ticagrelor), in~     participants with a recent acute coronary syndrome (ACS: including ST segment elevation~     myocardial infarction [STEMI] and non-ST-segment elevation acute coronary syndrome~     [NSTE-ACS]).~   "
97319|NCT02293382|"~     The objective is to perform a retrospective chart review to generate data to evaluate the~     clinical characteristics and course of disease progression of MPS IIIB.~   "
97387|NCT02292498|"~     The purpose of this study is to test the feasibility of using thermal images to diagnose~     bacterial pneumonia instead of a chest x-ray in the future. More specifically, the objectives~     of this study are: 1) to determine if thermal imaging, using a commercial thermal camera can~     detect areas of heat emitted from the chest in similar locations to where a chest X-ray shows~     focal consolidation consistent with bacterial pneumonia; 2) to evaluate whether changes in~     heat emitted from the chest changes over time if it is possible to obtain serial images of~     the chest.~   "
97320|NCT02293369|"~     American Congress of Obstetricians and Gynecologists (ACOG) advises minimally invasive~     methods in gynecological surgery to ensure increased benefits to the patient and reduce~     potential hospitalization costs.~      Laparoscopic hysterectomy has become the standard approach in gynecological benign disorders.~     During laparoscopic hysterectomy, vaginal cuff can be closed with different sutures,~     techniques and approaches, which is one of the challenges of this surgery. Data is limited on~     potential impact of different sutures, techniques and approaches for vaginal cuff closure on~     female sexual function in relation to vaginal length.~      Various studies in the literature evaluated different approaches (abdominal, vaginal,~     laparoscopic, robotic-assisted laparoscopic). In addition, for cuff closure, different~     techniques (interrupted, continuous) and sutures (barbed, Vicryl) were compared. Measures~     like operation time, cuff healing, complications, cost effectiveness, etc. were usually~     measured. However, there is no prospective randomized clinical study in the literature that~     compares laparoscopic approach with vaginal route for cuff closure in terms of female sexual~     function in relation to vaginal length.~   "
97321|NCT02293356|"~     This clinical study is designed as an open, single group, multi-center, phase 4 clinical~     study to assess the safety of Nimotuzumab in the treatment of nasopharyngeal carcinoma and to~     provide a more reasonable basis for clinical drug programs.~   "
97322|NCT02293343|"~     Over 24 hrs serum and plasma samples were collected every 3 hrs. With this a day histamine~     profile was created. 15 healthy persons with 20 patients with a high level of IgE in serum~     and 20 patients with afflictions but no high IgE level were compared. Measurment of histamine~     in plasma, urine and stool were realized. In addition to that Diaminoxidase, TNF alpha and~     IgE Antibodies were measured.~   "
97323|NCT02293330|"~     This study is developed to determine if the local anaesthetic dose can be reduced by the use~     of intermittent bolus technique compared to continuous infusion when the nerve catheter is~     placed underneath the paraneurium by ultrasound guidance in the popliteal fossa. Our primary~     outcome is local anesthetic use the first 48 hours after connecting the peripheral nerve~     catheter. Our hypothesis is that with an intermittent bolus less local anaesthetic is~     necessary the first postoperative 48 hours after surgery for adequate postoperative~     analgesia. As secondary outcomes the investigators study pain scores, motor block, sensory~     block, feeling of numbness, patient satisfaction, sleep quality and rescue analgesia during~     the nerve block and afterwards.~   "
97324|NCT02293317|"~     This is a single-site, randomized, double-blind, placebo-controlled study of Multimeric-001~     in thirty six (36) volunteers 50-65 years of age.~      All subjects will receive an intramuscular (IM) injection, in each one of three visits, with~     a 21±2 days interval between treatments.~   "
97325|NCT02293304|"~     The aim of this study is to evaluate the 18-month clinical performance of a multimode~     adhesive (Scotchbond Universal Adhesive, 3M ESPE, St Paul, MN, USA) in primary molars after~     partial carious removal. This randomized clinical trial will include subjects (5-10 year-old~     children) selected at two university centers (UFSM and FOUSP). The sample will consist of 132~     primary molars presenting active cavitated carious lesions (with radiographic involvement of~     the outer half of the dentin), located on the occlusal and occlusal-proximal surface. The~     sample will be randomly divided into two groups according to bonding approach: etch-and-rinse~     or self-etch strategy. The restorations will be clinically followed every 6 months for up to~     18 months using the USPHS modified criteria for clinical evaluation. Survival estimates for~     restoration longevity will be evaluated using the Kaplan-Meier method.~   "
97326|NCT02293291|"~     Although thermal therapy has been utilized in the rehabilitation of war veterans since the~     Roman Empire, no investigations actually exist about the use of thermal therapy in GWI, This~     due to the fact that nobody knows that the cure for the syndrome in GWI veterans may exist in~     thermal therapy which is the primary objective of this investigation.~   "
97327|NCT02293278|"~     The purpose of this pilot study is to test the efficacy of the physical activity (PA)~     intervention protocol to increase preschoolers overall PA levels and time spent in moderate~     to vigorous PA (MVPA) at the day care setting. The PA intervention includes the Healthy~     Opportunities for Preschoolers manual, a compilation of locomotor, gross motor and movement~     based activities developed for preschoolers and successfully piloted for feasibility in 3 to~     5 year old preschoolers by Drs. Viviene Temple, Justen O'Connor, and Patti-Jean Naylor. As~     well, the PA intervention includes educational workshops for the day care providers, ongoing~     biweekly facilitation and troubleshooting sessions with a Master Trainer, and the equipment~     necessary to implement the program. The study is also evaluating the efficacy of the PA~     intervention to decrease the amount of time spent in sedentary behaviour at the day care~     setting.~      Secondary objectives include evaluating the effects of the PA intervention on preschool~     children's anthropometrics, and fundamental and gross motor skills. In addition, the~     intervention is also assessing the effects of the program on day care provider's attitudes,~     control beliefs, and self-efficacy toward incorporating PA into the day care curriculum.~   "
97328|NCT02293265|"~     This will be a non-drug interventional cross-sectional study, where the screening visit and~     study visit can occur on the same day. Investigational product will not be administered.~     Approximately 790 subjects with severe asthma will be screened to achieve a total of at least~     750 evaluable study subjects. The study will not include a run-in or follow-up period. This~     study will provide a more reliable description of the severe asthma patient landscape with~     respect to the potential eligibility for treatment with mepolizumab, omalizumab, and~     reslizumab. This study aims to estimate the potential overlap of patients eligible for~     treatment with mepolizumab and those eligible for treatment with omalizumab and/or~     reslizumab. Additionally, the current study will also ascertain and describe reslizumab~     eligibility with respect to both mepolizumab and omalizumab, in the severe asthma patient~     population.~   "
97329|NCT02293252|"~     The primary endpoint is the incremental cost effectiveness ratio (ICER), defined as the~     combined clinical endpoint days alive and not in hospital nor stationary care per days in~     study and the change in total cost compared to that of the control group.~   "
97330|NCT02293239|"~     This study evaluates the effects of a 12-week whole-body electromyostimulation (WB-EMS)~     training combined with individualized nutritional support on body composition, muscle~     strength and function and quality of life of patients with malignant disease undergoing~     curative or palliative anti-cancer treatment~   "
97332|NCT02293213|"~     Investigators propose a randomized controlled trial of women taking category D or X~     medications seen in family medicine, internal medicine or in the Coumadin Clinic. Women in~     the intervention group will receive an electronic medical record referral for teratogen~     counseling and contraceptive counseling with a follow up contraceptive provision appointment.~     The contraceptive counseling will be adapted from The Contraceptive CHOICE Project script and~     promote the use of the long acting reversible contraception. The women in the control group~     will also receive an electronic medical record referral and receive the teratogen counseling~     but only be told that it is important to avoid becoming pregnant. An initial survey will~     assess contraceptive knowledge and utilization. In addition, there will be telephone survey~     at 3 months and 6 months to assess contraceptive utilization and continuation.~   "
97333|NCT02293200|"~     The aim of the study was to compare two methods of training in CPR, standard basic life~     support and CPR using CPR feedback device.~   "
97334|NCT02293187|"~     This one-year study will test the hypothesis that supplementation with vitamin D will improve~     lower extremity muscle performance in older men and women with vitamin D insufficiency.~   "
97335|NCT02293174|"~     Establish a normal baseline setting configuration for image capture using the Topcon~     TRC-NW400 non-mydriatic retinal camera.~   "
97336|NCT02293161|"~     GSK2618960 is a humanized Immunoglobulin G 1 ( IgG1) monoclonal antibody (mAb) that binds to~     the alpha component (CD127) of the heterodimeric Interleukin-7 receptor (IL-7R). It is being~     developed for the treatment of autoimmune indications. This study is intended to further~     explore the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and~     immunogenicity of single ascending doses GSK2618960 in healthy volunteers beyond those~     already evaluated in I7R116702 (First Time In Human study). The study is anticipated to enrol~     18 subjects in total, with 9 subjects in each of the two cohorts.~   "
97337|NCT02293148|"~     This study is being performed to comply with regulatory requirements that all new~     non-antiarrhythmic drugs must be assessed for potential effects on cardiac repolarization~     through electrocardiographic evaluation in a 'Thorough QT/ Corrected QT interval (TQT)'~     study. This will be a two part study, Part A will be an open-label, single oral dose study~     design in order to evaluate the pharmacokinetics, safety and tolerability of a 500 milligram~     (mg) dose of GSK1278863 and Part B will be a single-blind, randomized, placebo-controlled,~     single, oral dose, four-way crossover study design. Parts A and B will be conducted in~     healthy adult subjects with 12-lead electrocardiograms (ECGs), clinical laboratory safety~     tests, vital sign measurements, physical examinations, adverse event reports, and~     pharmacokinetic samples collected throughout the study.~   "
97338|NCT02293135|"~     The action of one Stendo pulsating suit session will be evaluated on 16 type 2 diabetic~     patients referred on the diabetic consultations. The effects of one Stendo pulsating suit~     session system will be assessed on the peripheral cutaneous microcirculation and on~     endothelial functions~   "
97339|NCT02293122|"~     The purpose of this study is to evaluate the precision and agreement of the study device, a~     specular microscope, in comparison to a currently commercially available specular microscope~     in establishing substantial equivalence of the two devices in clinical use for diagnostic~     purposes of the human cornea.~   "
97340|NCT02293109|"~     This phase I trial studies the side effects and best dose of carfilzomib when given together~     with the hyperfractionated (hyper)-cyclophosphamide, vincristine sulfate, doxorubicin~     hydrochloride, and dexamethasone (CVAD) chemotherapy regimen in treating patients with newly~     diagnosed acute lymphoblastic leukemia or lymphoma. Carfilzomib may stop the growth of cancer~     cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy,~     such as cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, and dexamethasone,~     work in different ways to stop the growth of cancer cells, either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading. Giving carfilzomib with~     combination chemotherapy may kill more cancer cells.~   "
97341|NCT02293096|"~     The investigators will prospectively follow a population of patients with uncontrolled high~     blood pressure beginning metoprolol succinate therapy to determine the drug effect in an~     observational clinical trial. The investigators will determine each individual's genotype for~     both CYP2D6 and Adrenoceptor Beta 1 (ADRB1). Metabolomic markers will be identified to~     determine if specific metabolites are associated with drug response. The investigators'~     overall objective is to determine if genetics predicts metoprolol succinate response better~     than clinical factors such as age, race, body mass index, dose, and medication co-ingestion.~   "
97342|NCT02293083|"~     Myofascial pain syndrome (MPS) is the most common cause of persistent regional pain~     characterized by myofascial trigger points. Trigger point injection (TPI) using local~     anesthetics is one of the most effective methods for treatment of MPS, and steroids or~     botulinum toxin can be added to local injections .~      Recent study suggested that the hyaluronan (HA) could be the basis of myofascial pain. HA~     within the deep fascia facilitates the free sliding of two adjacent fibrous fascial layers.~     If the HA assumes a more packed conformation, or more generally, if the loose connective~     tissue inside the fascia alters its density, the behavior of the entire deep fascia and the~     underlying muscle would be compromised.~      The investigators anticipated that hyaluronidase could decrease the viscosity of HA near the~     muscle and fascia of trigger points. Meanwhile, hyaluronidase is thought to promote the~     spread of local anesthetic solution by hydrolyzing glycosidic bonds within HA. Hyaluronidase~     was shown to be effective in retro- and peribulbar block for ophthalmologic surgery or~     reducing tissue edema in dermatology, and adhesiolysis for some interventional pain~     managements.~      However, the effect of the addition of hyaluronidase to local anesthetics during TPI has not~     been studied. The investigators aimed to compare the efficacy of TPI with the addition of~     hyaluronidase compared to local anesthetic alone on pain and quality of life in MPS patients.~   "
97343|NCT02293070|"~     The objective of this study is to utilize delayed enhanced cardiac magnetic resonance imaging~     to assess the success of pulmonary vein isolation after cryoablation of paroxysmal atrial~     fibrillation. The primary hypothesis is that cardiac magnetic resonance imaging will be able~     to visualize changes in left atrial tissue characteristics caused by cryoablation used to~     treat paroxysmal atrial fibrillation.~   "
97388|NCT02292485|"~     Investigators will administer a brief, anonymous survey at the Texas Academy of Family~     Physicians (TAFP) annual Primary Care Summit to better understand the readiness of primary~     care physicians in Texas to implement lung cancer screening programs in their practice~     settings.~   "
97344|NCT02293057|"~     Girls in the juvenile justice system have unique developmental pathways to drug use and~     co-occurring risk (e.g., HIV/STI) behaviors that have typically not been considered or tested~     in order to identify evidence-based gender-specific substance use treatment approaches for~     this population. This study will advance scientific knowledge and clinical practice in the~     drug treatment and public health fields by testing the efficacy of a pre-existing, widely~     disseminated gender-responsive substance use treatment (VOICES) on drug use and HIV/STI risk~     behavior outcomes for a broad range of substance using girls and young women (ages 12-24) who~     are at-risk for or already involved with the justice system.~   "
97345|NCT02293044|"~     This study will compare the safety and effectiveness of a potassium oxalate desensitizer on~     adjacent teeth with dentinal hypersensitivity.~   "
97346|NCT02293031|"~     The purpose of this study is to evaluate safety and efficacy of gene-activated matrix~     (Nucleostim) for regeneration of bone tissue in maxillofacial area. Patients with~     congenital and acquired maxillofacial defects (sockets of extracted teeth, bone defects after~     injuries, surgeries, excision of benign neoplasms and pseudotumors, etc.) or alveolar bone~     atrophy will be included into the study.~   "
97347|NCT02293018|"~     The purpose of this study is to determine the pharmacokinetic properties of topically applied~     MTC896 Gel following application of 0.75% (w/w) MTC896 Gel once daily and twice daily and~     1.5% (w/w) once daily over 4 weeks in the treatment of acne.~   "
97348|NCT02293005|"~     Objectives:~      Objectives~      The primary objective of this study is to:~      To assess 4-month disease control rate (DCR) in pre-treated patients with unresectable~     malignant pleural mesothelioma (MPM) treated with alisertib~      The secondary objectives of this study are to:~      To assess the response rate (confirmed and unconfirmed complete + partial responses) To~     assess the progression-free survival. To assess overall survival. To evaluate the side~     effects and toxicities associated with this treatment regimen.~      To collect archival tissue, blood, pleural effusion fluid and plasma for correlative studies.~      Exploratory Objectives:~      To collect archival or new tissue, blood and pleural effusion fluid for correlative studies.~     Tissue biomarkers to be evaluated include aurora kinase pathway and c-myc gene amplification.~      Next generation sequencing (NGS) will be conducted on adequate tumor tissue specimens.~   "
97349|NCT02292992|"~     The difference of lung volume change will be monitored by electrical impedance tomography~     before and after use of noninvasive positive pressure ventilation by nasal pillow and high~     flow nasal cannula in post-extubation patients.~   "
97350|NCT02292979|"~     This study aims to evaluate the efficacy of brentuximab vedotin + AVD combination~     (doxorubicine, vinblastine, dacarbazine) in patients with Hodgkin lymphoma stage I / II with~     an unfavorable diagnosis, assessed by the negativity of PET (positron emission tomography )~     after two cycles of chemotherapy.~   "
97351|NCT02292966|"~     The purpose of this study is to examine whether neurocognitive impairments experienced by~     patients with chronic hepatitis C virus (HCV) infection can be reversed by treating HCV, with~     a new combination of direct acting antiviral drugs (daclatasvir (DCV), asunaprevir (ASV) and~     beclabuvir (BCV)). The study will assess the effect of HCV on the central nervous system~     (CNS) by assessing neurocognitive function and brain injury prior to treatment, and comparing~     it to the end of treatment, and 4, 12 and 24 weeks after treatment.~   "
97352|NCT02292953|"~     The purpose of the study is to determine whether or not stressful conditions such as ovum~     pick and awaiting Embryo Transfer is associated with significant increase in serum Prolactin~     (PRL) concentration in some normo-prolactinemic patients undergoing intracytoplasmatic sperm~     injection (ICSI) & possible effect on implantation & pregnancy rate.~   "
97353|NCT02292940|"~     Patient use of health IT tools to interact with healthcare providers and delivery systems,~     including exchanging secure messages with their medical providers and using other web-based~     tools, has great potential to increase patient access to care, change the way healthcare is~     delivered, and affect patient clinical outcomes. This study will examine the impact of~     implementation and use of consumer health IT tools on patient-reported access to care,~     utilization of medical care services, and clinical outcomes.~   "
97354|NCT02292927|"~     DESIGN: Single-centre, feasibility study AIMS: The aim of this study is to evaluate the~     acceptability and pre-operative impact on functional capacity of a trimodal prehabilitation~     program in a cohort of patients undergoing aneurysm repair.~      This will enable the design (feasibility and power) of a large scale Randomised Controlled~     Trial.~      Expected outcomes~        -  The potential number of patients who would benefit, the compliance and acceptability of~          a pre-operative prehabilitation programme will be calculated.~        -  Preoperatively, expected at 6-weeks, the change in physical fitness of patients~          (assessed by the physical function section of SF-36 and measured with peak flow/6-minute~          walk testing) during the pre-operative phase will be assessed in both groups.~        -  The effects on quality of life, anxiety and depression on each study participant will be~          assessed immediately pre-op, expected at 6-weeks.~        -  The number of patients who are able to reduce or cease smoking will be reported during~          the pre-op phase (expected at 6 weeks), as will length of hospital stay after aortic~          surgery, expected at 6-8 weeks.~      POPULATION: Patients undergoing planned elective aortic surgery procedures~      ELIGIBILITY: Adult patients (over 18 years) undergoing elective open and endovascular~     aneurysm repair with capacity to consent and physical fitness to undergo an pre-operative~     exercise programme DURATION: 1 year from 1st June 2014~   "
97366|NCT02292771|"~     The primary objective of this study is to demonstrate the superiority of retosiban to prolong~     pregnancy in females with spontaneous preterm labor compared with atosiban. This objective is~     based on the hypothesis that prolonging the time to delivery in the absence of harm may~     benefit the newborn, particularly in women who experience spontaneous preterm labor at early~     gestational ages (GA). This study is designed to test this hypothesis through a direct~     comparison with atosiban, a mixed oxytocin vasopressin antagonist indicated for short-term~     use to delay imminent preterm birth in women between 24^0/7 and 33^6/7 weeks' gestation in~     preterm labor. This is a randomized, double-blind, double-dummy study, which consists of 6~     phases: Screening, Inpatient Randomized Treatment, Post Infusion Assessment, Delivery,~     Maternal Post Delivery Assessment, and Neonatal Medical Review. Approximately 330 females~     will be randomly assigned to retosiban or atosiban treatment in a 1:1 ratio. The duration of~     any one subject's (maternal or neonatal) participation in the study will be variable and~     dependent on GA at study entry and the date of delivery.~   "
97355|NCT02292914|"~     The robot-assisted surgery allows three-dimensional view, detailed access of small~     structures, depth perception and articulated movements with wide latitude. Thinking about the~     inclusion of this branch of surgical outcome ICESP encouraged the training of their doctors~     and other health professionals , and has three tutors in the area of robot- assisted~     laparoscopic surgery , and various medical clinical staff , already trained , and already~     perform the procedure in other centers . The da Vinci ® Surgical System ( only existing in~     the World market) , consisting of one or two consoles for the surgeon and a tutor if~     necessary was adopted. Ergonomically designed, a stand next to the patient , with four~     interactive robotic arms , one of them , a vision system for high performance and the other~     three for exclusive EndoWrist ® instruments . Driven by the latest robotic technology ,~     computer programs , frictionless transmission of manual controls , movements in scale and~     filtered made by the surgeon in the da Vinci ® System console are translated into precise~     movements of the instruments EndoWrist ® For surgeons , the da Vinci ® System offers superior~     3D viewing with larger surgical precision ergonomic comfort and dexterity . For hospitals ,~     the da Vinci ® Surgical System enables clinical and economic benefits of minimally invasive~     surgery are applied to a broader base of patients cirúrgicos.The main objective is to~     evaluate the safety and effectiveness of robotic surgery in the surgical treatment of cancer~     in operations below, as their specialties : Digestive , Urology , Gynecology , Head and Neck~     and Thorax . This is a prospective study lasting 36 months , where 1120 patients with~     surgical diseases in programming for the following operations will be studied : transthoracic~     esophagectomy ; subtotal gastrectomy with lymphadenectomy ; partial pancreatectomy ;~     resection of the rectum ; prostatectomy ; cystectomy ; partial nephrectomy ; hysterectomy~     with or without pelvic and paraaortic lymphadenectomy ; resection of malignant tumors of the~     mouth and orofaringolaringe and lung lobectomy . Patients will come from the outpatient~     services of the Institute of Cancer of São Paulo - ICESP~   "
97356|NCT02292901|"~     Videolaryngoscopes become widely used. The aim of this study is to compare McGrath Mac~     videolaryngoscope to conventional MacIntosh laryngoscope in patients without known risk of~     difficult of mask ventilation and of tracheal intubation.~   "
97357|NCT02292888|"~     Hypothesis: A validated technique to measure cardiac output (CO) using echocardiography is to~     calculate stroke volume from the product of LVOT area and LVOT VTI and multiplying the~     product with heart rate ( CO = SV x H/R; SV = LVOT area x LVOT VTI ).~      The LVOT diameter for an individual is more or less a constant measurement. Therefore using~     the formula mentioned above (SV = LVOT area x LVOT VTI), if the LVOT area is constant, then~     SV should be proportional to the VTI. This means if a PLR manoeuvre or fluid bolus helps to~     achieve a rise in SV, then it should be reflected in an increase in VTI as well. If this~     assumption is true, then an increase in the value of VTI from baseline after fluid challenge~     (10-15%), should identify a volume responsive patient.~   "
97358|NCT02292875|"~     Grass pollen allergens are recognised as a major cause of allergic diseases in humans and~     animals. Worldwide, at least 40% of allergic patients are sensitised to grass pollen~     allergens and between 50-90% of hayfever or seasonal allergy sufferers are allergic to grass~     pollen. ToleroMune Grass is a novel, synthetic, allergen-derived peptide desensitising~     vaccine, currently being developed for the treatment of grass allergy.~      The purpose of this optional observational follow-on study is to further evaluate~     rhinoconjunctivitis symptoms on exposure to Grass in the EEU among subjects who completed all~     dosing visits in study TG002 approximately two years after the start of treatment.~   "
97359|NCT02292862|"~     Maternal microchimerism has been discussed as an etiological mechanism in infantile~     (perinatal) biliary atresia (BA). In Kasai's operation (resection of the liver hilum plaque~     followed by hepato-portoenterostomy) surgeons frequently encounter swollen portal and~     mesenteric lymph nodes.~      Lymph nodes were sampled during Kasai' s operation and examined for maternal DNA.~   "
97360|NCT02292849|"~     The goal of this study is to test the feasibility, acceptability and preliminary impact of~     peer-delivered Behavioral Activation (BA) for depressed older adults (60+) who are Naturally~     Occurring Retirement Communities (NORC) residents or senior center participants.~   "
97361|NCT02292836|"~     The purpose of this study is to test and refine, a subject questionnaire aimed to be used in~     a general population rosacea prevalence study.~   "
97362|NCT02292823|"~     Prospective, non-randomized, single arm, multicenter observational study. The objective is to~     evaluate the safety and efficacy of the MGuard™ Prime stent in the treatment of de novo~     stenotic lesions in coronary arteries in patients undergoing primary percutaneous coronary~     intervention (PCI) due to acute ST elevation myocardial infarction (STEMI) in a real-world~     setting.~   "
97363|NCT02292810|"~     Type 2 diabetes is associated with respiratory muscle weakness and autonomic neuropathy. The~     exercise of inspiratory muscles has been investigating in various clinical situations and may~     cause similar benefits as the conventional exercises. The assessment of glucose variability~     has been used as an alternative tool to evaluate the others mechanisms than the absolute~     values of glucose levels, special during the exercise. However, the effect of inspiratory~     muscle exercise on glucose levels and glucose variability is not clear yet. The aim of the~     proposed research is to evaluate the acute effects of inspiratory muscle exercise using a~     high load of 60% of MIP on glucose levels and glucose variability in patients with type 2~     diabetes.~   "
97364|NCT02292797|"~     Multi-centre interventional cross-sectional prevalence study Assessment of the Rosacea~     Prevalence in the General Population.~   "
97365|NCT02292784|"~     The primary objective of this study is to assess the safety and outcomes of infants and~     children who were exposed to retosiban or comparator in utero in the planned Phase III~     spontaneous preterm labor (SPTL) treatment studies, to provide assurance that treatment is~     not associated with significant adverse outcomes in early childhood. The enrolled infants and~     children will be followed at pre-specified intervals until they reach 5 years chronological~     age. This study does not require medical interventions or study visits to an investigational~     site, instead, parents or legal guardians will be prompted at certain time points to complete~     developmental questionnaires and other data on their children's health status via an~     electronic device. Data collected during the infant and child follow up study will be managed~     by a centralized research coordinating center (RCC). Regionally based pediatricians will~     serve as study principal investigators (referred to as RCC-PIs) for this study. All~     communications the RCC-PI has with the parent/legal guardian or the child's health care~     provider (HCP) will occur remotely; there will be no clinic visits.~   "
97367|NCT02292758|"~     This randomized phase II trial studies how well irinotecan and cetuximab with or without~     bevacizumab work in treating patients with RAS wild-type colorectal cancer that has spread to~     other places in the body and cannot be removed by surgery. Irinotecan may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies,~     such as cetuximab and bevacizumab, may interfere with the ability of tumor cells to grow and~     spread. Giving irinotecan and cetuximab with or without bevacizumab may work betting in~     treating patients with colorectal cancer.~   "
97369|NCT02292732|"~     This is a Phase I, open-label, non-randomized, sequential, two-period, repeat-dose study to~     evaluate the effect of trametinib 2 milligram (mg) once daily on the repeat-dose~     pharmacokinetic (PK) of an oral contraceptive (OC) containing norethindrone (NE) and ethinyl~     estradiol (EE) (ORTHO-NOVUM® tablets: 1 mg NE + 0.035 mg EE) in female subjects with solid~     tumors.~      The study will determine PK interaction between trametinib and the components of combination~     oral contraceptives that would compromise the effectiveness of the contraceptives.~      The study will also evaluate the repeat dose PK of trametinib and its metabolite M5 using a~     validated assay.~      The study will enroll approximately 24 subjects. Each subject will participate in the study~     for approximately up to 13 to 15 weeks which will consist of a 30 day screening period,~     followed by 2 treatment periods (Period 1: 28 days and Period 2: ranging from 12 days to up~     to 21 days), and a transition visit or post-treatment follow-up visit. In Period 1, subjects~     will take one active tablet from the ORTHO-NOVUM® tablet 1/35 dial-pack once daily at~     approximately the same time each day for 21 days (Days 1 through 21), followed by one inert~     (referred to as placebo) tablet once daily at approximately the same time each day for 7 days~     (Days 22 through 28). In addition, subjects will take trametinib 2 mg (1 tablet) once daily~     at approximately the same time each day for a total of 17 days (Days 12 through 28). In~     Period 2, subjects will take one active tablet from the ORTHO-NOVUM® tablet 1/35 dial-pack~     once daily at approximately the same time each day for 11 days (Days 1 through 11). In~     addition, subjects will continue taking trametinib 2 mg (1 tablet) once daily at~     approximately the same time each day for 11 days (Days 1 through 11). ORTHO-NOVUM® is a~     registered trademark of Ortho Pharmaceutical Corporation.~   "
97370|NCT02292719|"~     The purpose of this study is to evaluate the safety and efficacy of ombitasvir/ABT-450/r with~     sofosbuvir with or without ribavirin in adults with Genotype 2 Chronic Hepatitis C Virus~     (HCV)infection or Genotype 3 HCV infection With or Without Cirrhosis.~   "
97371|NCT02292706|"~     This Registry will enroll cirrhotic participants with or without decompensated liver disease~     who have achieved a sustained virologic response (SVR) after receiving a sofosbuvir~     (SOF)-based regimen without interferon (IFN) while participating in a Gilead-sponsored~     hepatitis C virus (HCV) study or commercially at selected sites. Once enrolled, participants~     will be followed for up to 5 years.~   "
97372|NCT02292693|"~     The aim of this study was to compare time, success rates of different laryngoscope blades for~     intubation with an immobilized cervical spine in a standardized pediatric manikin model.~   "
97373|NCT02292680|"~     This study aims to identify early life exposures to metals and chemicals by measuring the~     concentration of metals and organic compounds in shed primary teeth. The researchers will~     also investigate associations between the presence of these chemicals in teeth and children's~     social, emotional, and neuro-development.~   "
97374|NCT02292667|"~     The ETAP study aim to assess the effect of the addition of an ultrasound-guided transversus~     abdominis plane (TAP) block to a multimodal intravenous analgesia protocol on the~     postoperative pain control in open surgical repair of abdominal aortic aneurysm. The ETAP~     study is a single-center open-label randomized controlled trial. Half of patients included~     will receive the association of TAP block and multimodal intravenous analgesia, and the other~     half will receive the multimodal intravenous analgesia alone. The multimodal intravenous~     analgesia includes intravenous paracetamol and intravenous patient-controlled analgesia with~     morphine.~   "
97375|NCT02292654|"~     Primary Objective:~      To evaluate the safety and tolerability of olipudase alfa administered intravenously in~     pediatric patients every 2 weeks for 52 weeks.~      Secondary Objective:~      To characterize the pharmacokinetic profile and evaluate the pharmacodynamics and exploratory~     efficacy of olipudase alfa administered intravenously in pediatric patients every 2 weeks for~     52 weeks.~   "
97376|NCT02292641|"~     In the UK approximately 28,000 patients per year are diagnosed with bowel cancer. Further~     15-20% develop pelvic recurrence. In a significant proportion of patients (15-20%), tumour~     extends beyond what the surgeon can routinely remove and requires more extensive~     (exenterative) surgery to achieve successful removal of the tumour. Currently MRI is used for~     the assessment of the pelvic tumour and PET/CT is used in order to prove that there is no~     extrapelvic disease, for the selection of patients who will undergo such a complex surgery.~     The investigators have previously shown, with a single centre retrospective analysis, that~     using a specific staging system for these tumours it is possible to predict both the~     likelihood of surgical success and overall survival outcomes. Until today there are no~     national guidelines for this group of patients.~      The investigators want to test whether standardizing the assessment of these advanced tumours~     will help to improve outcomes for patients and better surgical planning. The investigators~     also want to show that the information from the scans gives valuable data regarding the long~     term outcomes and likelihood of surgical success.~      This is a multicentre prospective trial of patients, who require more extensive surgery,~     using the staging classification. The high resolution MRI scans that patients undergo before~     surgery will be reported using the previously validated system.~      It is hoped that the study will result in a better and standarised method of assessing~     advanced pelvic cancer, with the intent to improve the surgical planning and overall patient~     management, which may increase the possibility of surgical curative resection.~   "
97377|NCT02292628|"~     This is a clinical trial phase I/II, double blind, randomized to compare in two groups of~     patients to evaluate the safety and efficacy of the autologous mesenchymal stem cells from~     the adipose tissue (CMMAd) in the treatment of the faecal incontinence.~   "
97378|NCT02292615|"~     In this prospective cohort study, patients with newly diagnosed gynecologic cancers~     (including cervical, endometrial, and ovarian cancers) and patients with suspicious recurrent~     gynecologic cancers will be enrolled. The study period is two years and the estimated patient~     number is about 220. Patients will undergo image study before and after treatment. The~     diagnostic accuracy of MR-PET in cancer staging and the potential image biomarkers to monitor~     treatment response and predict treatment outcome will be investigated.~   "
97379|NCT02292602|"~     The purpose of this study is to examine the feasibility, acceptability, and preliminary~     efficacy of a community and home-based preschool obesity intervention for families enrolled~     in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).~   "
97380|NCT02292589|"~     The purpose of this study is to determine the early effects of transcranial direct current~     stimulation (tDCS) in patients with mild traumatic brain injury and persistent post~     concussion syndrome(PPCS) with cognitive deficits in long term episodic memory and executive~     function(inhibitory control).~   "
97381|NCT02292576|"~     Evaluate if gene expression changes in SOD2 explain the health benefits of high polyphenols~     cocoa~   "
97382|NCT02292563|"~     The purpose of this study is to determine whether experienced endoscopy nurse participation~     during screening colonoscopy could increase polyp and adenoma detection rate.~   "
97389|NCT02292472|"~     This study design is A Randomized, Double-blind, Multi-center, Phase II Optimal Dose-finding~     Study to Determine the Safety and Efficacy of Meditoxin® in Subjects in Benign Masseteric~     Hypertrophy.~   "
97395|NCT02292394|"~     Caring for dependent persons can give rise to depression in non-professional caregivers,~     placing a burden on health care services and threatening the quality of the care dispensed to~     the dependent. Unfortunately, the ability of these patients to attend therapy sessions is~     often limited precisely by their role as caregivers. Preventive measures that are accessible~     to caregivers are thus called for. The primary aim of this project is to evaluate the~     efficacy of telephonic administration of a brief indicated preventive psychological~     intervention for depression that in previous work proved effective when administered in~     person in group sessions. With a view to optimizing resource usage by maximizing~     interventional efficacy, the secondary aim is to determine the contribution to overall~     efficacy of that part of the intervention that consists in increasing pleasant activities. To~     these ends, some 180 informed, consenting caregivers satisfying appropriate criteria for~     inclusion in the study will be randomized to one of three interventions (≈ 60 participants~     per intervention): the full cognitive-behavioural programme; a program focused only on the~     component of pleasant activities; or a usual care condition. Both programmes will be~     administered in five 90 minute sessions by audio tele-conference. All sessions will be~     recorded for verification of adherence to the intervention protocols. Participants will be~     re-evaluated at the end of their intervention (when participant satisfaction with the~     cognitive-behavioural programmes will also be assessed) and also 1, 3, 6 and 12 months later;~     all evaluations will be performed by trained interviewers who will be blind to the aims of~     the study, the interventions employed, and the group to which any given participant belongs.~     Analyses of these evaluations will compare the short- and long-term efficacies of the three~     groups. Factors that mediate participant improvement or predict results will also be~     investigated, and the cost-effectiveness of the interventions will be estimated.The central~     hypothesis of the proposed study is that a multicomponent cognitive-behavioral telephone~     intervention and a protocol assessing participation in pleasant activities will both~     significantly reduce the incidence of depression and depressive symptoms compared to a~     control group with usual care immediately after treatment and at 1-, 3-, 6-, and 12-month~     follow-up visits.~   "
97396|NCT02292381|"~     Glaucoma is one of the leading causes for blindness in industrialized countries. It is~     characterized by a progressive loss of retinal ganglion cells, morphological changes in the~     optic nerve head and a characteristic loss of visual field. Although increased intraocular~     pressure has been identified as the major risk factor for the development and the progression~     of the disease it has been speculated for a long time that impaired ocular blood flow may~     contribute to the pathogenesis of the disease. This concept has been supported by several~     epidemiological studies showing that low ocular perfusion pressure and small retinal vessel~     caliber are associated with the disease.~      The proposed study tests the hypothesis that patients with glaucoma have reduced total~     retinal blood flow as compared to healthy subjects. Additionally, autoregulation of blood~     flow will be investigated during an increase in ocular perfusion pressure. This is of~     importance because it may clarify the degree of vascular involvement in glaucoma.~   "
97397|NCT02292368|"~     The goal of this clinical research study is to learn which areas of the brain respond to~     acupuncture that is designed to prevent xerostomia (dry mouth) in patients with head and neck~     cancer. Researchers also want to learn if acupuncture can help prevent dry mouth and improve~     patient quality of life.~   "
97398|NCT02292355|"~     Introduction: the influence of temporomandibular disorders (TMD) related to postural changes~     are yet no consensus, but it is believed that the imbalances of a system can influence~     another. Several techniques have been used to treat TMD and its associated problems, however~     there is a paucity of studies evaluating the effects of global treatments, such as Pilates,~     in individuals with TMD literature. Objective: To evaluate changes in the level of pain, the~     severity of TMD, the EMG activity of masticatory muscles and posture of young women~     undergoing training in Pilates, as well as correlating postural changes, pain level, severity~     of TMD and EMG activity of masticatory muscles. A randomized clinical trial with blinded~     assessors will be held. 40 patients divided randomly into two groups will be assessed, the~     control group (CG) who receive conventional treatment with occlusal splint and intervention~     group (IG), which in addition to conventional treatment will undergo Pilates sessions. Both~     groups will be formed for women aged 18 to 35 years with TMD and pain. The IG will receive~     treatment with the Pilates Method for 15 weeks with frequency of twice weekly and use~     occlusal splint as directed by the dentist. The CG will make use of occlusal splint alone. At~     the beginning and end of the 15 weeks the individuals are evaluated to verify the presence of~     TMD, TMD severity, pain, EMG evaluation of masticatory muscles and body posture. Data will be~     analyzed statistically.~   "
97399|NCT02292342|"~     Aim: To investigate the dose-dependent vascular effect (primarily using FMD) of 3 low-level~     doses of pure (-)-epicatechin ≤ 1 mg/kg BW (0.1, 0.5 & 1.0 mg/kg BW) in healthy men.~   "
97400|NCT02292329|"~     The purpose of this study is to carry out a randomized double blind controlled trial in 30~     male subjects to investigate the effect of acai consumption on acute changes in vascular~     function, and to other cardiovascular markers. As a secondary aim the study will allow us to~     characterize the absorption and metabolism of acai polyphenols in humans over a 24 hour~     period.~   "
97401|NCT02292316|"~     The purpose of this study is to determine whether cognitive disorders are a risk factor for a~     fracture after a fall independently of a bone fragility.~   "
97402|NCT02292303|"~     The main objective of this clinical is to get information on pharmacokinetics of~     zinc-enriched yeast.The bioavailability of the yeast enriched with zinc will be compared to~     two selected zinc salts used in food supplements that are zinc oxide and zinc gluconate.~   "
97403|NCT02292290|"~     Dual therapy with metformin and Liraglutide is more effective at helping people with~     established Type 2 Diabetes Mellitus (T2DM) observing Ramadan achieve a triple composite~     endpoint of weight reduction and/or maintenance and improved HaemaglobinA1c (HbA1c) and no~     severe hypoglycaemic events.~   "
97404|NCT02292277|"~     Patients with myocardial infarction, which does not include all layers of the heart's muscle~     wall are common and they often receive pharmacological treatment with the platelet inhibiting~     drug ticagrelor. However, the drug uptake after an oral dose of 180mg ticagrelor has not been~     thoroughly studied in these patients.~      The present study will evaluate ticagrelor uptake and platelet aggregation after a 180 mg~     loading dose ticagrelor in these patients.~   "
97405|NCT02292264|"~     The aim of this study is to evaluate risk factors and complications of ventral hernia repair.~     A retrospective study of journal files with patients undergoing ventral hernia repair, and an~     analyses of complications by use of the Clavien-Dindo classification of surgical~     complications.~   "
97406|NCT02292251|"~     Stroke often results in limitation of arm movements, from which many people do not fully~     recover. We believe that early and intensive therapy is important to enhance recovery of arm~     movements after stroke. We are doing this research study to see how much arm movements~     improve with intensive therapy in patients have had a stroke in the past 6 weeks.~   "
97522|NCT02290743|"~     The purpose of this project is to investigate the effect of Kinesio tape on muscle strength~     of the quadriceps femoris in people with knee pain or symptoms and decreased muscle strength~     in the quadriceps femoris - a randomized controlled trial.~   "
97407|NCT02292238|"~     General Investigational Plan~      Study Objectives The goal of this proposal is to determine whether enhancing brain glucose~     utilization minimizes cognitive decline in patients with Amnestic Mild Cognitive Impairment~     (AMCI) or mild Alzheimer's disease (AD) dementia. We propose a proof of concept double-blind,~     placebo controlled pilot study to determine if increasing brain thiamine availability with~     the investigational new drug benfotiamine, will minimize the decline in glucose utilization~     and slow the cognitive decline associated with the progression AMCI/AD dementia.~      Specifically, our objectives are two-fold:~        -  To test whether increasing brain thiamine by administering 600 mg per day (300~          mg/morning and 300 mg/evening) of benfotiamine for one year can slow cognitive decline~          in these patients as measured with the Alzheimer's Disease Assessment Scale (ADAS-COG).~        -  To determine whether increasing brain thiamine availability with 600 mg (300 mg/morning~          and 300 mg/evening) per day of benfotiamine for one year can slow the decline in brain~          glucose metabolism in these patients as measured with Fluorodeoxyglucose Positron~          Emission Tomography(FGPET) in the posterior cingulate.~      We will also carry out the following secondary objectives:~        -  Assess if there are differences in secondary clinical outcome measures (NPI, ADCSADL,~          CDR, Buschke) between benfotiamine and placebo groups and whether specific cognitive~          domains (ie: activities of daily living, learning and memory verbal memory, behavioral,~          etc.) are driving these changes.~        -  Compare ADAS-COG change scores in the benfotiamine and placebo groups within and between~          strata that were defined by initial cognitive impairment, to attempt to identified the~          population that most benefits from benfotiamine.~        -  Compare changes in glucose utilization between the benfotiamine and placebo groups in~          secondary Regions of Interest (ROIs) including the hippocampus, prefrontal regions and~          entorhinal cortex.~        -  Compare changes in whole brain glucose utilization between the benfotiamine and placebo~          groups using statistical parametric mapping (SPM).~        -  Assess the correlation between changes in glucose utilization with changes in ADAS Cog.~        -  Determine if ApoE4 genotype alters the response to benfotiamine.~   "
97408|NCT02292225|"~     To evaluate the safety, pharmacokinetics, and pharmacodynamics of Duvelisib (IPI-145) in~     combination with obinutuzumab in patients with Chronic Lymphocytic Leukemia/Small Lymphocytic~     Lymphoma previously treated with a BTKi.~   "
97409|NCT02292212|"~     The purpose of the study is to obtain performance data on the Asahi ViE-21 dialyzer (ViE-21)~     .~   "
97410|NCT02292199|"~     Hypertension has high prevalence and poor control rates and is considered one of the major~     modifiable risk factors for cardiovascular system diseases, and one of the most important~     public health problems. The imbalance of the autonomic cardiovascular control, which can be~     considered as a major etiologic factor in the development of essential hypertension is~     characterized by increased sympathetic activity and reduced parasympathetic activity~     possible.~      Cardiovascular disease is the leading cause of death and disability in the world and~     autonomic imbalance is associated with several pathological conditions, and may be a final~     common pathway for the increased morbidity and mortality of cardiovascular diseases. In this~     sense, the heart rate variability (HRV) is a quantitative marker of sympathetic and~     parasympathetic activity, which can be used to assess disease and mortality as a noninvasive~     technique.~      TENS is a noninvasive therapeutic modality, easy to handle, it has no side effects or~     interactions with medications being used for the relief of pain by sensory stimulation~     through peripheral nerves and mainly for control and treatment of acute and chronic pain .~     Research on the effect of TENS on the sympathetic and parasympathetic nervous system activity~     remain controversial, especially regarding the parameters to use.~      The aim of this study is to investigate the effects of TENS on the sympathetic and~     parasympathetic nervous system in patients with hypertension by heart rate variability and~     blood pressure variability.~      This is a randomized clinical trial, double blind, where hypertensive patients were~     randomized to three groups: high-frequency TENS (100 Hz) n = 20, low frequency TENS (4 Hz) n~     = 20 and n = 20 placebo. Evaluations will be made in a single session. The results will be~     assessed by a blinded investigator and randomization will be done electronically.~      It is expected to evaluate how often TENS exerts more influence in the modulation of~     sympathetic and parasympathetic system.~   "
97411|NCT02292186|"~     The purpose of this study was to evaluate the safety and clinical activity of long-term~     dosing with revusiran (ALN-TTRSC). Dosing has been discontinued; patients are being~     followed-up for safety.~   "
97412|NCT02292173|"~     The main purpose of this study is to see whether the combination of trametinib and sorafenib~     can help people with hepatocellular cancer. Researchers also want to find out if the~     combination of trametinib and sorafenib is safe and tolerable.~   "
97413|NCT02292160|"~     The objective is to determine if data from the National Insurance Health card (giving~     antibiotics and hospitalizations in the past 18 months) allow to predict the individual risk~     of antibiotic resistance and to identify population groups for which probabilistic~     antibiotics regimen of urinary tract infection could be simplified~   "
97414|NCT02292147|"~     Descriptive and prognosis study of the functional outcome after cardiac arrest for the~     patients awake within the first 15 days.~   "
97415|NCT02292134|"~     Sleep architecture is deeply altered in intensive care unit (ICU patients). Among factors~     involved in poor sleep quality are environmental factors, such as light and noise, which are~     an unavoidable consequence of cares.~      The aim of the study is to evaluate the benefit of earplug and sleep mask on sleep~     architecture and quality in ICU patients.~   "
97416|NCT02292121|"~     In rodents, obesity is associated with changes in tight junctions' structure in small~     intestine, which impacts intestinal permeability and results in metabolic complications. Few~     data exist in human. We hypothesized that intestinal permeability is altered in obese~     subjects in comparison to lean subjects, linked to metabolic and inflammatory status and that~     these alterations are modified after gastric bypass.~   "
97417|NCT02292108|"~     High food impulsiveness, impaired food reward and stress response are involved in the~     phenomena of weight gain and resistance at weight loss. Henceforth, hypnosis is a~     complementary medicine which is recognized as effective for defined indications. Complexity~     and diversity of methodological studies with hypnosis does not allow to conclude on its~     efficacy in treating this disease.~      In obese subjects with high food impulsiveness, it is expected that Erickson's hypnosis and~     self-hypnosis practice would improve food disinhibition assessed by an adapted questionary~     (TFEQ 51).~   "
97418|NCT02292095|"~     The incidence of post-operative pain after open inguinal hernia repair is high and impair the~     quality of lives of the patients.The purpose of this study is to determine whether transverse~     abdominis plane block combined with intravenous patient controlled analgesia is superior to~     intravenous patient controlled analgesia in improving the quality of life and reducing the~     incidence of chronic post-surgical pain~   "
97419|NCT02292082|"~     Total knee replacement is associated with severe post-operative pain. The purpose of this~     study is to compare two methods of treatment for pain control following Total Knee~     Replacement with an accelerated physical therapy protocol to aid the achievement of rehab~     milestones.~   "
97420|NCT02292069|"~     This study is to assess the bioequivalence between Amlodipine besylate/Atorvastatin calcium~     Tablets 10mg/80mg of Dr. Reddy's Laboratories Limited, India and CADUET® (amlodipine besylate~     and atorvastatin calcium) tablets 10mg/80mg of Pfizer Ireland Pharmaceuticals Dublin, Ireland~     in healthy, adult,human subjects under Fed conditions.~   "
97473|NCT02291380|"~     A study, multi-center, randomized, double-blind, placebo parallel-controlled method, will be~     carried out to evaluate the safety and efficacy of Botulinum Toxin Type A for injection~     (HengLi®) for prophylactic treatment with chronic migraine in adults. In the core phase, two~     treatments of HengLi® or the placebo will be administrated (randomized at a ratio of 2:1, the~     target number is 288 subjects). In the extension phase, three treatments of HengLi® will be~     still administrated on 288 subjects recruited ever.~   "
97421|NCT02292056|"~     There is currently limited research that addresses the unique medication safety and family~     planning needs among women of reproductive age with psychiatric conditions. The study will~     research the feasibility of a novel individualized 1-on-1 counseling session at the Gifford~     Clinic in the Department of Psychiatry at UCSD that will help women in this population better~     understand: 1) which of their medications are safe to use in pregnancy, 2) provide education~     regarding the importance of using contraception and which contraceptive choices are available~     to them, and 3) raise awareness of any drug-drug interactions that may exist between their~     medications and their chosen method of contraception. Patients will be given questionnaire to~     assess their contraceptive utilization. They will also be given a before and after quiz to~     allow for an objective measure of the patient's increase in knowledge regarding medication~     safety and contraceptive choices as a result of the investigators intervention.~   "
97422|NCT02292043|"~     The investigators would evaluate the effects of the novel method, HTEA on cardiac function in~     the heart failure patients secondary to idiopathic dilated cardiomyopathy and post-myocardial~     infarction.~   "
97423|NCT02292030|"~     The purpose of this study is to explore the efficacy of low energy cardioversion on atrial~     fibrillation accompanied with chronic heart failure treated with HTEA or usual medicine.~   "
97424|NCT02292017|"~     This is a prospective single center trial investigating the effects of prospectively~     measuring packing density prior to choosing Target Coils for the treatment of intracranial~     saccular aneurysms. Up to 25 eligible subjects with ruptured or unruptured intracranial~     saccular aneurysms between 4-20mm (maximum dimension), who consent to study participation,~     will be treated with Stryker Target Detachable Coils.~      Historical data from patients enrolled in the MAPS trial at the single center will be the~     control arm of the trial and reviewed for comparison to the prospective arm. In the control~     arm, the subjects received Stryker Matrix2 Detachable Coils and Guglielmi Detachable Coils~     and packing density was not measured prior to these procedures. The Pro-Pack Trial will~     evaluate the outcomes of the subjects treated with Target Coils, in whom the packing density~     will be actively calculated prior to coil selection. This will serve to establish that a~     higher packing density can be obtained by the change in methodology of coil selection and a~     higher packing density with lower recurrence rates.~   "
97425|NCT02292004|"~     This study will assess the safety and early efficacy of a newly developed device,~     bridge-enhanced scaffold (MIACH™,) used to repair a torn anterior cruciate ligament (ACL.)~     Ten participants will undergo surgery with the new device (Experimental Group) and 10 will~     undergo a standard ACL reconstruction surgery (Control Group.)~   "
97426|NCT02291991|"~     This is a randomized, placebo controlled, single dose study to assess the safety,~     tolerability, pharmacokinetics and pharmacodynamics of GX-E2 in healthy male subjects.~   "
97427|NCT02291978|"~     The primary purpose of this protocol is to assess the ExAblate 2100 MR guided high intensity~     focused ultrasound device as an intervention for treatment of facetogenic lower back pain.~   "
97428|NCT02291965|"~     Specific Aim 1: To determine whether endogenous metabolomics-based biomarkers obtained before~     IV BU administration can predict IV BU clearance.~      Specific Aim 2: To characterize IV BU metabolism by metabolomics.~      Specific Aim 3: To identify covariates influencing IV BU pharmacokinetics.~   "
97429|NCT02291952|"~     The goal of this application is to determine whether changing the timing of food intake~     prevents the adverse metabolic effects of circadian misalignment.~   "
97430|NCT02291939|"~     The objective of the clinical trial is to determine the suitability of the FMwand~     Ferromagnetic Surgical System for parotidectomy and Head & Neck surgery.~   "
97431|NCT02291926|"~     The purpose of this study is to evaluate the safety and efficacy of human umbilical cord~     mesenchymal stem cell(hUC-MSC) for articular cartilage defect of knee.~   "
97432|NCT02291913|"~     Many patients with ER-positive or PR-positive breast cancer are treated with endocrine~     therapy. Although most ER/PR-positive tumors initially respond to hormonal therapy, patients~     often experience disease progression. Everolimus, in combination with exemestane, has shown~     activity in endocrine-resistant disease. This study will evaluate the efficacy of Everolimus+~     anti-estrogen therapy in patients with ER-positive metastatic breast cancer who have~     progressed after receiving anti-estrogen therapy.~   "
97433|NCT02291900|"~     The purpose of this study is to determine if surgical angiogenesis performed in talar~     avascular necrosis by free microvascular bone grafts from the femoral condyle is a superior~     technique compared to core decompression and nonvascularized osseous autografts.~   "
97434|NCT02291887|"~     A cohort of patients responsive to treatment with ranibizumab but resistant to~      aflibercept were identified in a previously conducted retrospective study. Identified~      patients will have their blood drawn for genome wide sequencing. The sequencing~      data will be compiled and analyzed in an attempt to identify a common genetic basis~      for patients susceptible to ranibizumab but resistant to aflibercept.~   "
97435|NCT02291874|"~     Purpose of this study is to evaluate the Long-term Safety, Tolerability, and Efficacy of~     Ipragliflozin in Combination with GLP-1 Receptor Agonists in Japanese Patients with Type 2~     Diabetes Mellitus Who Have Inadequate Glycemic Control with GLP-1 Receptor Agonists.~   "
97436|NCT02291861|"~     The purpose of this study is to determine whether fixed-doses of an investigational drug,~     SD-809 (deutetrabenazine), will reduce the severity of abnormal involuntary movements of~     tardive dyskinesia.~   "
97437|NCT02291848|"~     This study is for patients that have a cancer called Multiple Myeloma. This research study~     uses special immune system cells called tumor associated antigen (TAA)-specific cytotoxic T~     lymphocytes (CTLs), a new experimental therapy.~      The proteins that investigators are targeting in this study are called tumor associated~     antigens (TAAs). These are cell proteins that are specific to the cancer cell.They either do~     not show or show up in low quantities on normal human cells. In this study we target five~     common TAAs called NY-ESO-1, MAGEA4, PRAME, Survivin and SSX. On a different protocol,~     patients have been treated and so far this treatment has shown to be safe.~      Investigators now want to try this treatment in patients with multiple myeloma.~      These TAA-specific CTLs are an investigational product not approved by the Food and Drug~     Administration.~      The purpose of this study is to find the largest safe dose of TAA-specific CTLs, to learn~     what the side effects are, and to see whether this therapy might help patients with multiple~     myeloma.~   "
97438|NCT02291835|"~     Periodontitis is a chronic inflammatory disease and a significant risk factor for tooth loss.~     While a link between diet and periodontal health exists, the relationship between diet and~     healing following periodontal therapy has yet to be investigated.The objective of this study~     was to determine if higher intakes of foods and nutrients with antioxidant or~     anti-inflammatory activity are associated with reduced probing depth following sanative~     therapy. Sanative therapy is a first line cost-effective treatment to manage periodontal~     disease and thus prevent tooth loss. Patients with chronic generalized periodontitis~     undergoing sanative therapy were recruited for the study. Mean probing depth was assessed at~     baseline and 8-16 weeks following sanative therapy. Dietary intakes of fruits, vegetables,~     vitamins and dietary fats were estimated using the Block 2005 food frequency questionnaire~     and supplement use was recorded using a questionnaire. A small venous blood sample was also~     collected at baseline to measure serum 25-hydroxyvitamin D concentrations.~   "
97439|NCT02291822|"~     Collection of already existing data and images for patients < 2 years of age having~     MultiHance administration for a MRI of the brain or spine. MR Images will be reviewed during~     a prospectively designed blinded reading of the images.~   "
97440|NCT02291809|"~     The primary objective is to compare & evaluate between the treatment groups the changes in~     decline/reduction of HIV viral load & increase changes in WBC white blood cell counts in the~     adult Remune dose vs the low dose Remune placebo groups. Additional objectives include~     changes in CD4+ & CD8+ T cell counts along with increased HIV immunity.~   "
97441|NCT02291796|"~     Introduction: Plasma fibrinogen levels have been identified as an important risk factor for~     cardiovascular diseases and could have a prognostic value. Bezafibrate decreases fibrinogen~     levels and also the incidence of major cardiovascular events in primary prevention, but its~     effects in acute coronary syndrome is unknown.~      Hypothesis: Bezafibrate effect over statin therapy reduces fibrinogen concentrations,~     inflammatory response and clinical events, in patients with ST segment elevation ACS and~     hyperfibrinogenemia.~      Methods: In a randomized clinical trial, controlled with conventional therapy. Patients with~     ST elevation acute myocardial infarction (STEAMI) and with fibrinogen concentration >500~     mg/dl at 72 h of evolution, were randomly assigned to bezafibrate 400 mg/day (group I n=50)~     or just conventional therapy (group II n=50). Serum fibrinogen, c reactive protein and~     cytokines were measured. Clinical end points were recurrence of angina or infarction, left~     ventricular failure, cardiovascular mortality and combined end points during hospitalization.~   "
97442|NCT02291783|"~     The purpose of this study is to assess the safety, tolerability, pharmacokinetics and~     pharmacodynamics in young and elderly healthy volunteers of HTL9936, a selective M1 receptor~     agonist intended for the treatment of cognitive disorders.~   "
97443|NCT02291770|"~     Chronic Graft-versus-Host Disease (cGvHD) is a potentially lethal disorder. A variety of~     second line immunosuppressive agents have been investigated but no optimal treatment has~     emerged. There is therefore a need for novel treatment strategies. Mesenchymal stromal cells~     (MSC) exhibit immunomodulatory properties and a recent pilot study suggests a response rate~     of 70% in steroid- refractory patients. In the present randomized study the efficacy and~     safety of MSC treatment will be further studied in patients with cGvHD.~   "
97444|NCT02291757|"~     Objectives:~      Primary: To evaluate the efficacy of NEM® versus placebo in improving joint pain and~     stiffness in subjects with knee osteoarthritis. Western Ontario and MacMaster Universities~     Osteoarthiritis Index (WOMAC)), Likert Scale, Range of Motion (ROM) evaluation and Visual~     Analogue Scale (VAS Scale) will be used as joint pain and stiffness scales for efficacy.~      Secondary: To evaluate the safety and tolerability of NEM® treatment.~   "
97445|NCT02291744|"~     The primary endpoint is to evaluate the TFS (time to failure of strategy).~   "
97446|NCT02291731|"~     To evaluate the clinical effect of combination of topical 20% (v/v) autologous serum eye~     drops and a silicone-hydrogel contact lens (CLs) in the treatment of recalcitrant persistent~     epithelial defects (PEDs) and the recurrence rate of epithelial breakdown with or without~     continued use of autologous serum eye drops.~   "
97447|NCT02291718|"~     The purpose of this study is to compare the contrast agents and imaging techniques used for~     thoracoabdominal aortic imaging in CT. Imaging parameters and contrast volume are changed and~     adjusted based on the contrast agent, since contrast agents have varying iodine~     concentrations. If the contrast iodine concentration is higher, it may be possible to adjust~     the imaging parameters and lower the overall radiation dose to the patient.~   "
97448|NCT02291705|"~     Inguinal hernia repair is one of the common day-case surgery in children. The aim of this~     study is to compare the effects of ultrasound guided rectus sheath block and intravenous~     tramadol on peroperative anesthetic requirement and postoperative analgesia.~   "
97449|NCT02291692|"~     The investigators aimed to evaluate the effect of ultrasound guided thoracic paravertebral~     block with bupivacaine on both perioperative anesthetic agent consumption and postoperative~     analgesia in pediatric patients undergoing percutaneous nephrolithotomy for kidney stone.~   "
97450|NCT02291679|"~     The objective of this trial was to determine the efficacy and safety of linaclotide 72 ug~     administered once daily to patients with chronic idiopathic constipation (CIC). The primary~     efficacy parameter is the percentage of participants in each dosing group that meet the~     protocol definition for complete spontaneous bowel movement (CSBM) Overall Responder.~   "
97470|NCT02291419|"~     The purpose of this pilot study is to establish the rate of cardiovascular events in patients~     with elevated troponins levels after major, non-cardiac surgery and to evaluate the efficacy~     and safety of FDA approved study drug (ticagrelor) compared to aspirin in these patients.~      Data from current studies suggest that myocardial injury detected by minor elevations in~     troponin levels within 3 days after non-cardiac surgery may occur in 10-24% of patients and~     is associated with an increased risk of mortality at 30 days and 1 year. There are no current~     guidelines for care of patients with elevated troponin levels in the absence of acute~     coronary syndrome. This study will assess if the increased risk of these patients is~     modifiable by an anti-platelet medication and evaluate the safety of this medication.~      Patients will be randomized in an open label fashion to receive ticagrelor (anti-platelet~     medication) or 81 mg. aspirin. Patients will be followed on study treatment for 12 months,~     with the last contact at one month post treatment discontinuation.~   "
97451|NCT02291666|"~     Type 2 diabetes (T2D) could modulate CYP450 activities involved in drug-metabolism and~     cardiovascular homeostasis. We propose to carry out, for the first time, a comprehensive~     characterization of the effects of T2D on the expression and activity of major CYP450s. In~     our studies, patients with T2D will be studied since hyperglycaemia and/or hyperinsulinemia~     are believed to modulate CYP450s. This vicious cycle puts patients at risk of micro- and~     macro-vascular complications and inadequately controlled T2D due to high intersubject~     variability in drug disposition and action.~      Characterization of the effects of T2D on drug metabolism capacity will be performed using a~     cocktail of CYP450 probe drugs.~      CYP450 phenotype will be determined in 3 groups of patients (n=126 patients): 1) 42 T2D~     patients with good glycemic control; 2) 42 T2D patients with poor glycemic control; and 3) 42~     non-T2D healthy subjects following a single oral administration of a cocktail of CYP450 probe~     drugs. Subjects will receive the CRCHUM-MT cocktail consisting of caffeine (CYP1A2),~     bupropion (CYP2B6), tolbutamide (CYP2C9), omeprazole (CYP2C19), dextromethorphan (CYP2D6),~     midazolam (CYP3A4/5) and chlorxozaxone (which will be administered separately) (CYP2E1).~     Serial blood samples will be drawn and urine collected. Metabolic ratios will be calculated~     and compared between three groups of subjects. Other co-variables to be studied include T2D~     biomarkers at baseline (glucose, insulin, HbA1c), medications, genetic polymorphisms and~     inflammatory markers.~      Our cocktail probe drug approach should allow us to demonstrate the effects of T2D on the~     activity of major CYP450s. Moreover, this project will indicate to us whether glycemic~     control should be considered as a covariate of intersubject variability in drug metabolism~     capacity.~   "
97452|NCT02291653|"~     We hypothesized that the McGrath MAC EMS is beneficial for intubation of pediatric manikins~     while performing CPR. In the current study, we compared effectiveness of the McGrath MAC EMS~     and MIL laryngoscopes in child resuscitation with and without CC.~   "
97453|NCT02291640|"~     The aim of this study was to compare time, success rates of video laryngoscope and direct~     laryngoscope for the emergency intubation with an immobilized cervical spine in a~     standardized pediatric manikin model.~   "
97454|NCT02291627|"~     The aim of this study was to compare time, success rates of different video laryngoscopes for~     the emergency intubation with an immobilized cervical spine in a standardized pediatric~     manikin model.~   "
97455|NCT02291614|"~     The purpose of this Phase 1 study is to determine if AMG 211 given as a continous IV infusion~     is safe and tolerable in adult subjects that have advanced gastrointestinal adenocarcinoma.~     The study will be conducted in multiple sites and test increasing doses of AMG 211. The~     safety of subjects will be monitored by intensive assessment of vital signs,~     electrocardiograms, physical examinations, and laboratory tests. Efficacy will be assessed by~     the usual imaging procedures and their interpretation.~   "
97456|NCT02291601|"~     Demonstrate the reduction of bacteria on the skin.~   "
97457|NCT02291588|"~     This first-in-human, multicenter study to evaluate the administration of placebo or AMG 811~     single subcutaneous and intravenous dose to subjects with SLE~   "
97458|NCT02291575|"~     The rural healthcare market in much of the developing world is composed largely of informal~     private providers. These private providers often have little to no certifiable medical~     training. Recent studies in India using medical vignettes (or hypothetical medical~     situations) to measure clinical competence and direct observations of doctor-patient~     interactions to measure clinical practice highlight the poor quality of care that most~     patients receive—a problem that is clearly relevant beyond India and affects most low-income~     countries worldwide. For instance:~        1. In rural India, standardized patients presenting with chest pain and (on further~          questioning) radiating pain in the arm are (correctly) diagnosed with a heart attack in~          less than 25 percent of cases.~        2. Across 8 low and middle-income countries, health care providers completed the four~          necessary vital statistics for new patients in less than 4 percent of interactions:~          health care providers in the public sectors of many developing countries routinely spend~          less than 1 minute per patient.~      To address these deplorably low standards in both medical knowledge and practice, the Liver~     Foundation in Kolkata has been working with private rural health care providers through~     capacity building activities to improve quality in the private sector. The program consists~     of multiple-week training to private rural health care providers on the basis of a~     well-developed curriculum in the district of Birbhum, West Bengal.~      This study aims to assess the impact of this training program using a randomized evaluation,~     in which providers are randomly assigned to the treatment, i.e. the Liver Foundation's~     training program, or the control, i.e. no such training. As an independent outside evaluation~     team, we will run a baseline survey for all providers (through a third party data collection~     agency), monitor the application of and compliance in the Liver Foundation's training~     intervention, and conduct a final endline study. By comparing the treatment and control~     groups on a variety of measures developed to capture competence in provider knowledge and~     practice, we can rigorously assess whether such a training program for informal rural health~     care providers is an effective means of improving provider medical knowledge and practice in~     the short run. It is worth noting that this study will not be able to capture long run~     effects , such as price or location changes, on health care for the rural poor.~   "
97459|NCT02291562|"~     THC and CBD have distinct symptomatic and behavioral effects. In healthy individuals, THC can~     induce psychotic symptoms and anxiety, and can impair memory. In contrast, CBD has anxiolytic~     and possibly antipsychotic properties, while not impairing memory and other cognitive~     functions. Instead, CBD has been shown to have significant neuroprotective effects. In~     humans, CBD values correlated positively with gray matter concentration in bilateral~     hippocampus. Recent data from experimental animals and in vitro studies suggest that these~     distinct effects might be caused by opposing effects on brain cannabinoid receptors.~      Neuroimaging studies have consistently identified brain activity recorded at prefrontal and~     medial temporal regions as relevant for episodic memory. Additionally, the abundance of~     cannabinoid receptors in the hippocampus and the parahippocampal and entorhinal cortices~     suggests a potential impact of CBD in memory deficits typical in healthy aging. However, the~     evidence relating cannabinoids to these conditions is relatively recent and has been obtained~     from either biochemical or pharmacological studies. It might be hypothesized that CBDs could~     be useful to delay or even arrest the progression of functional and structural neuronal~     degeneration.~      The investigators will use an episodic memory paradigm to test the effects of THC, CBD and~     placebo on memory encoding and retention and the underlying neuronal networks on healthy male~     subjects.~   "
97460|NCT02291549|"~     The RESOLVE II Study is a randomized, single-blind, parallel arm, concurrently controlled,~     multicenter study with 300 chronic sinusitis patients who had prior endoscopic sinus surgery~     but present with recurrent sinus obstruction.~   "
97471|NCT02291406|"~     Insulin resistance is a key reaction to surgery and trauma and reflects the degree of~     metabolic stress. With greater degree of insulin resistance the development of complications~     increase, in particular infectious complications. The aim of this study is to determine if~     robotic assisted total laparoscopic hysterectomy induces less insulin resistance compared to~     abdominal hysterectomy. Insulin resistance is measured by the hyperinsulinemic normoglycemic~     clamp method. In addition inflammatory factors and clinical recovery will be measured.~   "
97461|NCT02291536|"~     Attentional blink refers to a phenomenon where the detection of the second of two target~     stimuli that are presented in Short succession within a stream of stimuli is impaired. This~     is explained by an insufficient availability of attentional resources. Additionally,~     emotionally salient stimuli, like for example pictures with a positive or negative content,~     are detected more often compared to neutral pictures during this attentional blink period.~      Cannabinoids are involved in the modulation of cognitive, attentional, and emotional~     processes. Interestingly, data from animals suggests that THC and CBD, both active~     ingredients in the Cannabis sativa plant, have opposing effects on brain cannabinoid (CB1)~     receptors. CB1 receptors modulate the expression of emotionally salient conditioned~     association in rats, if salience processes in humans are modulated in the same way remains~     unclear.~      Employing a task to detect salient stimuli, Bhattacharyya et al. (2012) showed that THC seems~     to make non-salient standard stimuli more salient. They showed decreased activation of the~     right caudate and increased right prefrontal cortex stimuli during processing of salient~     stimuli. Importantly, this was associated with decreased response times to standard relative~     to oddball stimuli. Generally, THC and CBD differentially modulate brain areas associated~     with attentional salience processing. For example THC seems to increase prefrontal and~     striatal activation whereas CBD seems to decrease it.~      The investigators assume that THC increases the number of correctly detected emotional~     stimuli during the attentional blink period, whereas CBD has no effect. Additionally, the~     investigators assume that pictures of the positive category are detected with higher accuracy~     than negative ones under the influence of THC.~   "
97462|NCT02291523|"~     Ninety Six patients with mild to moderate ulcerative colitis will be randomized to double~     blind, placebo controlled study. The safety and efficacy of the intervention will be closely~     monitored.~   "
97463|NCT02291510|"~     This study compared the pharmacokinetics (PK) and assessed the safety of delayed-release~     metformin (Met DR, EFB0027) at two dosage levels, immediate-release metformin (Met IR,~     ETB0015), and extended-release metformin (Met XR, ETB0014) in healthy subjects.~   "
97464|NCT02291497|"~     Hypophosphatasia (HPP) is a rare, inherited metabolic disease caused by inactivating~     mutations in the Alkaline Phosphatase (ALPL) gene, coding for the Tissue-nonspecific alkaline~     phosphatase (TNAP). Penetrance and disease severity is very heterogenous, ranging from~     stillbirth to adult-onset manifestations. Especially the latter are again characterized by an~     extremely broad spectrum of symptoms. This scope of variability makes it difficult to~     attribute individual patients' symptoms to the disease and distinguish them from HPP~     independent health issues. Especially in adult HPP patients, musculoskeletal problems,~     including (fragility-) fractures / bone bruise, joint pain, reduced mobility, muscular~     weakness and pain and reduced muscular endurance appear to reflect the prevailing burden of~     disease, especially with respect these patients dis-abilities of daily life.~      To expand current knowledge of the natural history of the disease as well as on disease~     specific musculoskeletal deficits in HPP, all adult patients with established Diagnosis of~     HPP known at the Orthopedic Institute, University of Würzburg, will be offered to participate~     in a single, multimodal assessment of their disease history, current symptoms and~     disabilities, lab evaluations and clinical and technical analysis of their musculoskeletal~     status and capabilities.~      Patients will be invited to a day long visit to the clinic in order to perform the following~     assessments:~      A) Epidemiologic / anamnestic information B) Physical examination C) Structured~     questionnaires D) Laboratory examinations E) Clinical functional testing F) Technical~     Examinations~   "
97465|NCT02291484|"~     Multi-center, randomized-controlled trial comparing a comprehensive cardiac CT protocol with~     standard stress testing in patients with stable chest pain complaints.~   "
97466|NCT02291471|"~     The purpose of this study to assess the MTD and Pharmacokinetics of T0001 in Healthy Adult~     Chinese Volunteers.~   "
97467|NCT02291458|"~     The South Asian population is facing an epidemic of type 2 diabetes, of which the underlying~     cause is still unknown. It is currently hypothesized that an ethnic susceptibility towards a~     disturbed energy metabolism may underlie this disadvantageous metabolic phenotype. In line~     with this, the investigators recently discovered that Dutch South Asian subjects have 32%~     lower resting energy expenditure (REE) and 34% lower energy-combusting brown adipose tissue~     (BAT) compared to matched white Caucasians. Nitric oxide (NO) was recently shown to be~     crucial for BAT development and, interestingly, South Asians have diminished NO~     bioavailability. Thus, the disadvantageous metabolic phenotype in South Asians may be caused~     by diminished NO bioavailability resulting in lower BAT volume. Therefore, the investigators~     hypothesize that increasing NO generation in the body by administration of L-arginine, the~     precursor of NO, will improve their metabolic phenotype by increasing BAT volume, thereby~     increasing REE and clearance of triglycerides and glucose by BAT. To investigate this, the~     investigators will perform a randomized placebo-controlled multicenter cross-over study in~     moderately obese Dutch South Asians and matched white Caucasians. Subjects will receive~     L-arginine (9 gram/day) or placebo for 6 weeks, followed by a wash-out period of 4 weeks and~     then again 6 weeks of one of either treatments. At the end of both treatment periods, a~     cold-induced PET-CT scan will be performed. Furthermore, muscle and fat biopsies will be~     obtained and thermoregulation will be assessed.~   "
97468|NCT02291445|"~     This is a pilot study to compare the relative bioavailability between two peppermint oil~     formulations, namely a colon-targeted-delivery capsule (Tempocol-ColoPulse®) and an~     enteric-coated capsule (Tempocol®). This study is conducted as part of a future multicenter~     randomized controlled trial that will assess the therapeutic effect of the new peppermint oil~     formulation in IBS patients.~   "
97469|NCT02291432|"~     To study the safety of autologous muscle-derived cells (AMDC) for the treatment of male~     stress urinary incontinence (SUI) for patients that have undergone prior prostate surgery.~   "
97472|NCT02291393|"~     The diagnosis of Arrhythmogenic right ventricular cardiomyopathy can be difficult. The 80~     lead ECG may increase the specificity and sensitivity in diagnosing this potentially life~     threatening inherited cardiac condition. This pilot would form the basis of a much larger~     clinical trial to test the utility of this novel diagnostic tool.~   "
97474|NCT02291367|"~     This study were to compare the relative bioavailability of Duloxetine HCl delayed release~     capsule 60 mg with that of 'CYMBALTA®' delayed release capsule 60 mg (Duloxetine HCl delayed~     release capsule 60 mg) in healthy, adult, human subjects under fasting conditions and to~     monitor safety of subjects~   "
97477|NCT02291328|"~     Brassica vegetables are an important part of the investigators normal diet and are associated~     with a reduced risk of many chronic diseases. The protective effect may be as a result of the~     hydrolytic products of compounds contained within these vegetables, called glucosinolates.~     There is evidence that consumption of Brassica vegetables may cause compositional changes to~     the investigators gut microbiota. The aim of this study is to see whether a diet rich in~     Brassica alters the human gut microbiota composition, and specifically whether it causes an~     increase in the number of the beneficial bacteria known as lactobacilli.~   "
97478|NCT02291315|"~     Adequate calcium absorption is essential for reducing one's risk of developing osteoporosis.~     However, postmenopausal Thai women consume diets which are habitually low in calcium due to~     lactose intolerance and dietary patterns which typically do not include milk-based products.~     The primary goal of this study is to measure the fractional calcium absorption from milk and~     a commonly ingested green leafy vegetable (cassia) in postmenopausal Thai women with~     habitually low calcium intakes. The secondary objective is to determine associations between~     calcium absorption and biomarkers which impact vitamin D status and bone metabolism.~   "
97479|NCT02291302|"~     The investigators goal is to determine the efficacy of school/classroom based environmental~     intervention in reducing asthma morbidity in urban schoolchildren.~   "
97480|NCT02291289|"~     This randomized, multi-center, active-controlled, open-label, parallel-group study will~     investigate the efficacy and safety of biomarker-driven maintenance treatment for first-line~     mCRC. Participants with mCRC are eligible for entry and cannot have received any prior~     chemotherapy in the metastatic setting. The entire study duration is anticipated to be~     approximately 7.5 years.~   "
97481|NCT02291276|"~     In this prospective, observational study the investigators assess the perioperative course of~     right ventricular function in combination with the venous return in patients undergoing major~     non-cardiac surgery. The study aims to investigate if patients undergoing major non-cardiac~     surgery develop an impairment of right ventricular function and/or venous return.~     Furthermore, the study evaluates if an impairment of right ventricular function and/or venous~     return is associated to left ventricular function, arterial side of the circulation and to~     postoperative clinical outcome.~   "
97482|NCT02291263|"~     This study will be an open-label phase III randomized clinical trial comparing different~     combinations and regimens of polio vaccines. The trial will compare one and two doses of IPV~     administered at 6 weeks or 14 weeks or 6 and 14 weeks of age. All participants will also~     receive bOPV at 6, 10 and 14 weeks of age.~   "
97483|NCT02291250|"~     Dietary strategies for alleviating health complications associated with type 2 diabetes (T2D)~     are being pursued as alternatives to pharmaceutical interventions. Berries such as~     blackcurrants that are rich in polyphenols may influence carbohydrate digestion and~     absorption and thus postprandial glycaemia. In addition berries have been reported to alter~     incretins as well as to have anti-oxidant and anti-inflammatory properties that may also~     affect postprandial glycaemia. This study investigated the acute affect blackcurrants on~     glucose metabolism in overweight/obese volunteers .~   "
97484|NCT02291237|"~     The primary objective of this study was to evaluate the effect of eleclazine (GS-6615) on~     exercise capacity as measured by Peak oxygen uptake (VO2) achieved during cardiopulmonary~     exercise testing (CPET), in participants with symptomatic hypertrophic cardiomyopathy (HCM).~   "
97485|NCT02291224|"~     This trial will evaluate a multi-component, clinic-based intervention aimed at increasing~     dual protection strategy selection and adherence among young African American females at an~     urban family planning clinic. Dual protection is the use of contraceptive strategies to~     prevent both unintended pregnancy (UIP) and sexually transmitted infections (STIs). This is~     an unblinded randomized controlled trial; participants will either get the interactive~     multimedia platform focused on DP strategies with intervention arm counseling or the standard~     of care arm counseling.~      The study will recruit 710 African American females aged 14-19 who are attending the Grady~     Health System (GHS) Teen Services Clinic (TSC) in Atlanta, Georgia, for reproductive health~     care.~      The trial will recruit and enroll 710 young women presenting to the clinic for clinical care~     who have the following characteristics:~        -  self-identify as African American,~        -  14-19 years of age,~        -  have had vaginal sex with a male partner in the past 6 months,~        -  HIV-negative by self-report,~        -  not pregnant,verified by urine pregnancy test,~        -  no desire to be pregnant in next 12 months,~        -  plan to stay in the Atlanta area for the next year,~        -  are willing to provide contact information, and~        -  were not previously enrolled in the pilot study of this intervention.~      Those enrolled will be in the study for 12 months. Young women who are eligible and give~     written consent or assent for study participation will be enrolled. Half will be randomized~     to the control arm, half to the intervention arm.~        1. Control arm (standard of care) includes individual clinical care and standard of care~          counseling consistent with protocols at the TSC, with study visits for data collection~          at enrollment, 6 months, and 12 months, during which any medical care or counseling that~          they would normally get will also be provided. Control arm participants will also get~          telephone calls from clinic staff to update their contact information and remind them of~          upcoming visits at 3 weeks and 5 months after the enrollment visit, and at 3 weeks and 5~          months after the 6 month visit.~        2. Intervention arm, consisting of the following intervention components:~             1. Enrollment visit~                  -  A culturally-appropriate interactive multimedia platform focused on DP~                    strategies and designed to prepare the individual for selection of a DP~                    strategy.~                  -  Individual intervention arm counseling to select the DP strategy that is best~                    suited for the participant (by a clinic health care provider).~                  -  Individual intervention arm counseling to build skills for correct and~                    consistent use of the selected DP strategy (by a nurse educator (NE)).~             2. Booster counseling via phone at about 3 weeks and 5 months after the enrollment~               visit, and at about 3 weeks and 5 months after the 6 month visit (by an NE).~             3. 6 month visit~                  -  An abbreviated version of the interactive multimedia platform focused on dual~                    protection strategies and strategy adherence.~                  -  Individual intervention arm counseling to reinforce skills for correct and~                    consistent use of the DP strategy (by an NE).~      At the final study visit at 12 months there is no difference between the counseling provided~     to the two groups; participants in both arms will receive the clinic standard of care.~      Participants in both arms of the study will follow the same data collection procedures~     throughout the study:~        -  At all three study visits, participants in both arms will receive urine pregnancy and~          STI tests and complete an audio computer assisted self-interview (ACASI) questionnaire.~        -  At 3 and 9 months after enrollment, participants in both arms will receive a data~          collection call with administration of a telephone questionnaire.~      Throughout the study, all participants will be encouraged to come in for evaluation if they~     have any concerns. Any data from pregnancy or STI testing at these interim clinic visits will~     be later collected via chart review. If participants seek reproductive health care at other~     facilities during the study period, records will be requested with participant permission,~     and data from pregnancy or STI testing at these outside clinic visits will be collected via~     review of records received.~      We will examine the efficacy of the intervention arm relative to control arm across the~     following primary behavioral and biologic outcomes over the 12 months of follow-up:~        1. Self-reported dual protection strategy selection~        2. Self-reported dual protection strategy adherence~        3. Incidence of pregnancy or infection with chlamydia, gonorrhea or trichomonas (as~          confirmed by laboratory testing)~      A small pilot study was be conducted prior to the initiation of enrollment in the main study.~   "
97486|NCT02291211|"~     This study is designed to investigate the efficacy of S-1 plus cisplatin hyperthermic~     intraperitoneal chemotherapy for advanced gastric patients of gastric cytoreductive surgery~     (CRS)~   "
97487|NCT02291198|"~     This study will look at measuring the activity of natural killer (NK) cells using the in~     vitro diagnostic device NK Vue in subjects being screened for colorectal cancer using~     colonoscopy. The NK Vue diagnostic test for natural killer cell activity uses the principle~     of stimulation of whole blood with a proprietary cytokine followed by the quantitative~     detection of interferon gamma using an immunoassay. NK Vue is intended to be used for the~     monitoring of the immune status of individuals. Measurement of NK cell activity could be a~     useful tool for assessing changes in immunosurveillance in patients with conditions or~     diseases where NK cell activity has been shown to be reduced, such as colorectal cancer.~   "
97488|NCT02291185|"~     The beach chair position (BCP) has been commonly used for shoulder arthroscopic surgery.~     Hemodynamic instability is frequently encountered problem associated with BCP. In addition,~     high rates of cerebral desaturation events have been reported during surgery in BCP. Although~     fluid loading could alleviate hypotension associated with BCP, it may lead to volume~     overload. As an alternative to static indices, dynamic preload indices such as pulse pressure~     variation (PPV) and stroke volume variation (SVV) were reported to be sensitive predictors of~     fluid responsivness in several surgical condition. The investigators will examine the~     abilities of PPV and SVV to predict fluid responsivness during shoulder arthroscopic surgery~     in BCP. Using transesophageal echocardiography (TEE), the investigators will directly~     estimate the change of cardiac output during BCP.~   "
97489|NCT02291172|"~     Overview The goal of Comprehensive Communication Intervention for Minimally Verbal Children~     with Autism is to conduct an efficacy study of a promising intervention to increase spoken~     language in preschool children who are minimally verbal. The proposed study compares a~     comprehensive communication intervention (JASP- EMT Plus; JEP) to a business as usual (BAU)~     control group in a randomized controlled trial (RCT) across 4 time points. The study~     replicates and extends procedures used by Kasari, Kaiser et al (2014) to successfully promote~     social communication in older minimally verbal children. Intervention components include: (1)~     Joint Attention, Structured Play, Engagement and Regulation and Enhanced Milieu Teaching~     (JASP- EMT), (2) applied with systematic parent training, (3) use of speech generating device~     (SGD) and (4) supplementary direct teaching of foundational skills for language learning as~     indicated by child entry skills (CORE-DTT; Smith, 2009). Children who remain minimally verbal~     beyond age 5 are at high risk for persistent, severe communication deficits that impact~     social development, educational achievement and quality of life (Tager-Flusberg & Kasari,~     2013). Thus, there is an urgent need for effective strategies to promote communication~     development during the preschool years to ameliorate early communication deficits and prevent~     persistent minimally verbal status. This study aims to change social communication in~     minimally verbal preschool children with ASD by applying a naturalistic social communication~     intervention which teaches the social foundations of communication and functional use of~     verbal language in play and interaction. In addition, the intervention addresses three~     factors that may contribute to remaining minimally verbal: lack of an effective mode of~     speech production, lack of foundational skills for learning language (receptive language,~     imitation, joint attention), and lack of communication partners to support continued language~     learning in natural environments.~   "
97523|NCT02290730|"~     The purpose of this project is to investigate the effect of Kinesio tape on muscle strength~     of the lower trapezius in people with shoulder symptoms and decreased muscle strength in the~     lower trapezius - a randomized controlled trial.~   "
97490|NCT02291159|"~     Introduction: Stroke is a neurological deficit caused by a decrease in cerebral blood flow.~     The DNHS ® (Dry Needling for hypertonia and Spasticity) technique is a dry needling technique~     to reduce spasticity and hypertonia and improve function in patients with CNS injury. The~     main objective of this trial is to analyze the therapeutic effect of DNHS® technique in motor~     function in patients between 45 and 80 in a chronic state after a stroke. Methods:~     Double-blinded randomized clinical trial. There will be an intervention group (DNHS®~     technique) and a sham control group. The intervention will be 2 sessions, one per week, in~     biceps brachii, brachialis, flexor digitorum superficialis nad profundus, adductor pollicis~     and first dorsal interossei. The Fugl Meyer Assessment Scale, Modified Ashworth Scale and~     Stroke Impact Scale will be used as outcome measures. The data will be expressed as mean ±~     (Standard Deviation). The standardized difference or effect size (ES, 90% confidence limit)~     in the selected variables will be calculated.~   "
97491|NCT02291146|"~     The overall goal of this project is to conduct a randomized controlled 12-week after school,~     gardening, nutrition and cooking program (called LA Sprouts) to improve dietary intake and~     reduce obesity in 3rd, 4th and 5th grade students (ages 8-12 years) in Los Angeles.~     Approximately 400 3rd - 5th grade students participating in the LA's Best after school~     program will participate. Four elementary schools in Los Angeles will be selected to~     participate in the study. Schools will be randomized by region to either receive the~     intervention (LA Sprouts; 2 schools, n=200 students) or serve as controls (received a delayed~     intervention program one school semester later; 2 schools, n=200 students). The LA Sprouts~     intervention will take place at the elementary schools, with gardens on campus specially~     designed and built for this project. The program will be held once a week for 12 weeks and~     will consist of a 45-minute gardening lesson, taught by Master Gardeners from the University~     of California Cooperative Extension (supervised by Nicole Gatto, MPH, PhD), and a 45-minute~     nutrition education and cooking lesson, taught by USC a Nutrition Educator (supervised by~     Jaimie Davis, PhD, RD). Measures of childhood obesity (i.e., body mass index (BMI) and body~     fat percentages), blood pressure, metabolic function (fasting blood glucose, insulin and~     lipids), dietary intake and related behaviors, and school performance will be measured before~     and after the implementation of the program in both intervention and control participants.~     Approximately 10 additional students of the same age will be asked to participate in a focus~     group to evaluate the questionnaire developed for this study. In addition, approximately 20~     additonal students of the same age will be asked to participate in a test-retest session to~     validate the reliability of the questionnaire.~   "
97492|NCT02291133|"~     The aim of the study is to evaluate toxicity and effectiveness of electrochemotherapy with~     bleomycin in treatment of primary liver tumors in clinical study phase I and II.~      The study will include 10 patients in phase I clinical study and additional 15 patients in~     phase II clinical study (or in the extension of the clinical study), which will fulfill~     inclusion criteria.~      Treatment effectiveness will be evaluated by DCE-US or CT perfusion, to detect early events~     in tumor perfusion after ECT compared to tumor perfusion before ECT. Long term effectiveness~     of the treatment will be evaluated by modified RECIST criteria, which will take into account~     difference in size and density, determined from images obtained by CT perfusion of the~     treated tumor nodules before and after ECT. Tumor volume will be calculated by following~     formula , where a will be shorter and b longer tumor diameter.~      The secondary objectives of the trial are to quantify the impact of the treatment on the~     patient's quality of life, tolerance to the therapy and suitability for larger study to be~     conducted.~   "
97493|NCT02291120|"~     The objective of the study is to evaluate and compare, clinically and radiographically,the~     effects of MEDCEM PC and MTA when used as pulp dressings following pulpotomy in human primary~     molars.~   "
97494|NCT02291107|"~     In Multiple Sclerosis (MS) gait disorders represent one of the most disabling aspect that~     strongly influence patient quality of life. The improvement of walking ability is a primary~     goal for rehabilitation treatment. Current promising rehabilitative approaches for~     neurological disorders are based on the concept of the task-specific repetitive training.~     Hence, the interest in automated robotic devices that allow this typology of treatment for~     gait training. However, studies on the effectiveness of such methodologies are still poorly~     numerous in terms of functional improvement in MS patients. The aim of this controlled~     cross-over study is to evaluate the effectiveness of a Lokomat gait training in patients~     affected by Multiple Sclerosis in comparison to a ground conventional gait training.~   "
97495|NCT02291094|"~     This study aims to compare quality of perioperative analgesia of lidocaine and remifentanil~     intravenously in surgical interventions for the treatment of breast cancer.~   "
97496|NCT02291081|"~     The HIV/HEART study (HIVH) is an ongoing, prospective, multicentre trial that was conducted~     to assess the incidence, the prevalence and the clinical course of cardiovascular diseases~     (CVD) in HIV-infected patients. The study population includes outpatients from specialized~     HIV-care units of the German Ruhr region, who were at least 18 years of age, were known to~     have a HIV-infection and exhibited a stable disease status within 4 weeks before inclusion~     into the trial. From March 2004 (Pilot phase) to May 2014 (7,5 year Follow-up) 1481 HIV+~     patients were recruited in a consecutive manner. The standardised examinations included a~     targeted assessment of medical history and physical examination. Blood was drawn for~     comprehensive laboratory tests including HIV specific parameters (CD4 cell count, HIV-1 RNA~     levels) and cardiovascular items (lipid concentrations, BNP values and renal parameters).~     Furthermore, non-invasive tests were performed during the initial visit, including additional~     heart rate and blood pressure measurements, electrocardiogram (ECGs) and transthoracic~     echocardiography (TTE). Examinations were completed in accordance with previously defined~     standard operating procedures. CVD were defined as coronary, cerebrovascular, peripheral~     arterial disease, heart failure or cardiac vitium.~   "
97497|NCT02291068|"~     The Objectives of the current research is to evaluate whether psychological flexibility~     influences psychotherapy outcomes in patients with adjustment disorder and depression. If~     indeed this is the case, we would be able to identify risk factors for low adjustment- such~     as low psychological flexibility, and develop psychotherapy that would try to enhance this~     ability.~   "
97779|NCT02287363|"~     The study aims to analyze the genetic variance between thyrotoxic periodic paralysis (TPP)~     patients and pure hyperthyroidism individuals. Meanwhile, the investigators also intended to~     evaluate the morphological difference in effected skeletal muscles and investigate their~     relation with genetic variance.~   "
97501|NCT02291016|"~     The purpose of this study is to compare drug delivery and lung function after treatment with~     formoterol from a nebulizer versus a dry powder inhaler (DPI) in patients recovering from~     severe exacerbations of COPD. This is to determine if one device is superior in providing~     better lung function and drug deposition in this clinical setting.~   "
97502|NCT02291003|"~     Circadian clocks are not only found in discrete areas of the brain, but are found in~     virtually every organ in our bodies, including the heart, lungs and immune system.~     Disruptions in circadian clocks, or chronopathology, may underlie various forms of~     cardiovascular, pulmonary, and metabolic disorders. Over the past two decades, molecular~     geneticists have cracked the clock to reveal its core biochemical mechanisms evident in~     organisms from fruit flies to humans. These mechanistic insights have led to the discovery of~     links between clock function and an ever-expanding array of prevalent diseases, including~     heart, lung, metabolic and sleep disorders. Yet the prevalence of circadian disruption in~     these patient populations is unclear because current tests are not easily applied in clinical~     settings or have yet to be developed. Here the investigators exploit our newfound~     understanding of clock mechanisms and the development of new genomic technologies to identify~     novel complements of clock-regulated genes (signatures) that will reveal the state of the~     internal biological clock. This approach will allow us to take a genomic snapshot of clock~     status from a single blood draw, substantially easing the diagnosis of these individuals with~     evidence of circadian disruption or misalignment, i.e., chronopathology.~   "
97503|NCT02290990|"~     Imaginative Distention (ID) is proposed as supportive and integrative intervention to cope~     with fatigue, (principal end point), to cope with insomnia, stress perception and to improve~     QoL of pw MS, insomnia pw and health care personnel. ID is safe and it can be easily learned~     and practised without of any particular instrument and also feasible in disabled pw. This~     technique allows persons to experience the body as a source of well-being and not just~     fatigue, pain and disease. ID can become a self managed tool of empowerment to cope with MS,~     to reduce its negative impact on daily life and job performances. Adherence to~     pharmacological therapies could be improved using ID.~      For pw MS ID could have specific and customizable rehabilitation implications to improve~     motor disability, as already seen in stroke patients. The principal end point of the trial is~     verify ID efficacy on fatigue and its specificity on pw MS at the end of the training. For~     this reason, ID efficacy will be tested in comparative terms too. Among all possible~     comparison populations, we selected: pw insomnia, which is stress related disease and health~     personnel, because at risk of stress. The control groups comparison permits to evaluate the~     specificity of ID on pw MS. The three groups are randomised to intervention or waiting list.~     The training is 8 weekly session long. Self administered questionnaire are filled by~     participants before and after the training, and 3-6 months later. The extent of change in~     outcome measure monitored in each exposed group vs. unexposed will allow to separate the~     non-disease specific effect of ID from the MS-specific effect. The difference in estimates~     will allow to determine the extent of the true effect of ID in pw MS. All outcome measure~     will be compared among all groups mentioned and over time. The study would identify also the~     most important outcome measures for MS patients questioning them in a focus group. This~     aspect is very important because could differs from which clinicians and researchers think~     about.~   "
97504|NCT02290977|"~     The presence of portal vein tumor thrombosis (PVTT) in patients with hepatocellular carcinoma~     (HCC) is one of the most significant prognostic factors for poor prognosis, without~     treatment, their survival is less than 3 months. In the HCC patients who combined with PVTT,~     Radiation therapy (RT) showed 50% of local control and about 10 months survival duration.~     Despite the standard treatment of the HCC combined with PVTT is sorafenib, but Korean Liver~     Cancer Study Group (KLCSG) recommend RT as an alternative option in those patients.~     Investigators previously reported the retrospective study that the scheduled interval~     Trans-catheter Arterial Chemo-embolization (TACE) followed by RT for HCC combined with PVTT~     and 60% of the patients showed objective response without significant elevation of~     complication. However, the prospective outcomes of TACE followed by RT for HCC are scantly~     reported. Based on those background, we start this prospective study to evaluate the clinical~     outcomes and adverse event in the RT after TACE in the unresectable HCC patients who combined~     with PVTT.~   "
97505|NCT02290964|"~     This study is aimed to determine if acute normovolemic hemodilution (ANH), an established~     blood conservation technique, reduces the requirement for allogeneic blood transfusion in~     operations with prediction of surgical bleeding over 20% of estimated blood volume (EBV)~   "
97506|NCT02290951|"~     This is an open-label, multi-center, dose escalation study of REGN1979 administered as an IV~     (intravenous) infusion. This phase 1 study will investigate the safety and tolerability of~     REGN1979 in patients with Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)~   "
97507|NCT02290938|"~     The investigators plan to develop and test a new alcohol and other drug (AOD) intervention~     for urban AI/AN youth, Motivational Interviewing and Culture for Urban Native American Youth~     (MICUNAY). This intervention integrates tradition-based activities and motivational~     interviewing (MI). The investigators will intervene at both the community and individual~     level. At the individual level, they will provide MICUNAY to adolescents. At the community~     level, they will provide discussion of AOD prevention at Community Wellness Gatherings (CWG).~     This work is important because they will gain an understanding of how well a tradition-based~     healing program that integrates MI works to prevent AOD use among urban AI/AN youth.~   "
97508|NCT02290925|"~     The investigators intend to conduct a double blind randomized clinical trial to investigate~     the effect of a biscuit containing herbal extract, available in the market on the fasting~     blood sugar control in patients with diabetes mellitus and also to find out whether there are~     any side effects on other vital organs such as kidneys and liver.~   "
97509|NCT02290912|"~     This is a randomized controlled trial to develop and test the efficacy of a multi-domain~     lifestyle behavioral intervention designed to promote healthier lifestyle behaviors linked to~     lower Alzheimer's disease risk among persons aged 40 to 64 years.~   "
97510|NCT02290899|"~     The main purpose of this study is to investigate how the brain responds to a procedure known~     as transcranial direct current stimulation (tDCS) and how tDCS affects performance on a~     behavioral task. Research suggest that this procedure leads to improvement in brain and~     behavioral measures of inhibitory control (controlling impulses) in healthy control~     participants. The investigators want to explore whether the same improvement will be seen in~     kids with ADHD.~   "
97511|NCT02290886|"~     A multicenter phase I/II Clinical trial,randomized, controlled with placebo, triple blind to~     evaluate the safety of the intravenous administration of 3 doses of autologous mesenchymal~     stem cells cells from adipose tissue in patients with Amyotrophic Lateral Sclerosis (ALS).~   "
97512|NCT02290873|"~     A prospective, double-blind, randomized, placebo and active controlled, multi-center,~     parallel group study comparing remimazolam to placebo, with an additional open-label arm for~     midazolam, in patients undergoing a colonoscopy for diagnostic or therapeutic reasons.~   "
97513|NCT02290860|"~     Gestational diabetes mellitus (GDM) is defined as a hyperglycemia with onset or first~     recognition during pregnancy. GDM complicates 5 to 25% of pregnancies, depending on the~     diagnostic criteria used and the population being studied.~      GDM is an important red flag: up to 70% women with GDM will develop type 2 diabetes mellitus~     (T2DM) during their lifetime. Accordingly, professional associations recommend T2DM~     postpartum screening (T2DM-pP-S), 6-to-24 weeks after delivery. A 75g oral glucose tolerance~     test (OGTT) should be performed for diagnosis (gold standard). Nevertheless, this T2DM-pP-S~     recommendation has failed worldwide for the same reasons: the presently impractical pattern~     of the testing. A solution is direly needed.~      Our overall goal is to improve detection of pre-diabetes and diabetes and more specifically,~     to facilitate the recommended T2DM-pP-S in women diagnosed with GDM.~      We hypothesize that, in GDM women, results of an OGTT performed after delivery, before~     hospital discharge (OGTT-1) predict results of the recommended OGTT at 6-to-12 weeks~     postpartum (OGTT-2). Our aims are:~        1. To validate in Caucasian women the predictive threshold value of the 2hr-glucose of~          OGTT-1 established by our Stage-1 study.~        2. To determine, in a multiethnic non-Caucasian cohort, the threshold value for the~          2hr-glucose of OGTT-1 that is predictive of abnormal glucose tolerance at OGTT-2.~        3. To define the OGTT time preference of women (before hospital discharge vs. 6-to-12 weeks~          postpartum).~      If our results are in line with our Stage-1 data, most redundant 6-to-24 weeks postpartum~     OGTT will be avoided. Medical practice will change.~   "
97514|NCT02290847|"~     The primary objective of this study is to evaluate the effectiveness of Cognitive Processing~     Therapy (cognitive only version; CPT-C) delivered using two different formats in the home~     setting for the treatment of combat-related PTSD as compared to conventional face-to-face~     CPT-C delivered in a mental health clinic. The study will include two different formats of~     in-home therapy: face-to-face in-home CPT-C and tele-behavioral health in-home CPT-C.~   "
97515|NCT02290834|"~     This research study evaluates the effect of chemotherapy on cognition (thinking) and the~     brain in people with breast cancer.~   "
97516|NCT02290821|"~     This study will assess the analgesic efficacy of DSG 1% compared to placebo in the reduction~     of the pain associated with acute blunt trauma injuries.~   "
97517|NCT02290808|"~     This study will be investigating whether a theory-based physical activity intervention can~     maintain/improve moderate to vigorous intensity physical activity measured via accelerometry~     of new parents over the eight months of having a child compared to a control group of new~     parents.~      Hypothesis: The theory-based condition will change salient underlying motives (theory of~     planned behaviour constructs) for physical activity. Health-related fitness and quality of~     life will also be higher for this condition in comparison to the control condition. (Note:~     improvements in both groups of mothers may occur due to recovery from pregnancy, but our~     hypotheses will still hold). All outcomes will remain significantly higher at eight months in~     the theory-based condition compared to the standard condition~   "
97518|NCT02290795|"~     The vitreous fills the posterior chamber of the eye and is firmly attached, at the posterior~     pole, to the macula and the optic nerve head (ONH). With formation of a stepwise posterior~     vitreous detachment (PVD) exerted tractional forces could influence retinal functioning.~     Especially in patients with glaucoma the influence of vitreous traction to the ONH could mask~     progression, interfere with current imaging techniques and even be a cause of ONH~     hemorrhages. Therefore the aim of this study is to investigate whether vitreopapillary~     traction has a significant effect on diagnosis and follow up of glaucoma patients.~   "
97519|NCT02290782|"~     This prospective, multicentric single arm phase IV study is based on the protocol of the~     international TARGIT-A and TARGIT-E study.~      Patients ≥ 50 years with small, low-risk breast cancer who are operated but not irradiated~     show local relapse rates around 6% after 5 years. With adjuvant whole breast radiotherapy~     (WBRT) the local relapse rate drops to under 1% after 5 years under Tamoxifen (4).~      It has been demonstrated (6, 9, 10) that the efficacy of radiation of the tumor bed only in a~     selected group can be non-inferior to WBRT.~      The TARGIT C study should confirm the efficacy of a single dose of intraoperative~     radiotherapy (IORT) in a well selected group of patients with small breast cancer and absence~     of risk factors. In presence of risk factors postoperative WBRT will be added to complete the~     radiotherapeutic treatment according to international guidelines.~      Endpoints are the local relapse rate (within 2 cm of the tumor bed), ipsilateral relapse,~     cancer-specific and overall survival and contralateral breast cancer as well as documentation~     of quality of life and cosmetic outcome.~      The expected local relapse rates are 0.825/1.375% after 3/5 years, respectively.~     Discontinuation of the trial is scheduled if rates of local relapse rates rise to 1.55/2.4/4%~     after 1/3/5 years. Power calculations result in 387 patients with a calculated dropout and~     loss to follow-up rate of 10%, an alpha of 0.05 and a beta of 0.10. There will be only a~     pre-pathology stratum.~      It is a pragmatic trial in which each participating centre has the option to modify entry~     criteria and criteria for WBRT according to this core protocol after consultation with the~     steering committee and local ethics committee (e.g. size, free margins). Only centers with~     access to the Intrabeam® system (Carl Zeiss) can recruit patients into the trial.~   "
97520|NCT02290769|"~     The aim of this study is to compare the cannulation time during primary wire guided ERCP~     (Endoscopic Retrograde Cholangio-Pancreatography) according to two different length of guide~     wire: long wire or short wire rapid exchange, artery by a prospective randomized trial.~   "
97521|NCT02290756|"~     The investigators propose to develop and test the efficacy of a low cost evidence based~     toolkit aimed at improving brain development among newborns a rural setting of Pakistan. The~     toolkit will include a safe delivery kit, nutritional supplementation, and trainings on cord~     care, hypothermia management, aspiration and bag and mask techniques and APGAR score~     calculation. A simple, home-based parenting program will also be implemented that will teach~     parents tools that provide stimuli for brain and cognitive development in children. This~     parenting program covers Early Childhood Interventions for children at risk of developmental~     problems and covers developmental skill areas such as cognitive and fine motor, social and~     self-help and gross motor skills. Such an intervention package provides comprehensive care to~     families at the community level, with a minimal cost that can be scaled up. A new cadre of~     Link workers will be implemented who will provide mentoring and supportive supervision to~     Birth Attendants and will train parents in the stimulation program. The study will recruit~     1080 pregnant women and their newborns.~   "
97524|NCT02290717|"~     Rationale: Vitiligo is a common skin disorder that can impair a patient's quality of life.~     Many depigmented lesions in vitiligo patients remain therapy resistant for medical treatment.~     Therefore new therapeutic options in these patients are necessary. Currently, dermabrasion by~     conventional or fractional laser therapy in combination with NB-UVB therapy and steroids~     appears to be effective in therapy resistant areas. However, little literature on this~     combination is available.~      Objectives: To assess the efficacy and patient safety of (1)fractional CO2-laser treatment in~     combination with NB- UVB,(2) fractional CO2-laser treatment in combination with NB- UVB and~     topical corticosteroids versus NB-UVB treatment alone(3) Study design: Prospective observer~     blinded randomised intra-patient controlled study.~      Study population: 23 patients ≥ 18 years with non segmental vitiligo who receive NB-UVB~     treatment at the Netherlands Institute for Pigment Disorders (SNIP) at the Academic Medical~     Centre University of Amsterdam. We will include patients with 3 depigmented lesions that are~     resistant to NB- UVB treatment after 3 to 6 months.~      Methods: Three NB-UVB resistant depigmented regions on the trunk or extremities will be~     randomly allocated to;(1) NB-UVB treatment in combination with fractional CO2 laser abrasion,~     or (2) NB-UVB treatment in combination with fractional CO2 laser abrasion and topical~     steroids, or (3) NB-UVB treatment alone. NB-UVB treatment and topical steroids will be given~     according to the standard treatment protocol of the SNIP and continued for at least 6 months.~     Two and 6 months after the laser treatment, the percentage of repigmentation of the lesions~     will be assessed.~   "
97525|NCT02290704|"~     Find if the retinal function is affected in both the nonsevere and the severe stage of~     Graves' ophthalmopathy (GO) by comparing the retinal oxygen saturation of GO patients with~     that of normal people.~   "
97526|NCT02290691|"~     The purpose of this study is to determine if the administration of flu vaccine using~     Needle-Free is equivalent to Needle and Syringe administration as measured by laboratory~     tests of immune response.~   "
97527|NCT02290678|"~     Team building exercises have been shown to be effective in improving an individual's ability~     to work within a group and build working relationships with others. Adventure Therapy~     assimilates team building exercises and teachings into an adventure style excursion into the~     wilderness or other non-typical environment. This combination of exposure and learning~     creates a unique experience for participants which preliminary research suggests is effective~     in reducing feelings of hopelessness, guilt, and shame and may increase empathy,~     self-concept, self-confidence, and subjects' well-being have also been shown to be improved~     by adventure therapy.~      This study will use a series of questionnaires and interviews to determine whether an~     adventure based therapy is both effective and reasonable as a treatment for people with mood~     disorders like depression and anxiety. The objective of this study is to investigate the~     efficacy of adventure based therapy as a treatment intervention for outpatients with mood~     disorders. The investigators will observe any changes in mood, perceived self- efficacy,~     anxiety, self-stigma, hope, quality of life enjoyment and satisfaction, leisure motivation,~     and stress as a result of this intervention. As well, the investigators aim to capture~     participant's opinions of the program.~   "
97528|NCT02290665|"~     The purpose of this study is to determine the patient preference for a biocompatible~     thermosensitive solution-gel versus water or saline (liquid) enema.~   "
97529|NCT02290652|"~     -  Non-commercial trial~        -  2 Centres involved: University Hospital Southampton and Spire Southampton~        -  Expected number of eligible participants available per year: 100, (95% expected to agree~          to participation)~        -  The study will recruit prospectively female patients aged 18 - 65 years undergoing THR.~          A retrospective series of similar patients who have had a hip replacement will also be~          recruited.~        -  This is a research project that will run over 2 years. Data from 200 patients will be~          collected and analysed:~      Retrospective 30 question questionnaire: 'Arthroplasty & Sexual Function Questionnaire (ASFQ)~     - Post-operative' Version 1.3 11/07/14~      Prospective 23 question questionnaire: 'Arthroplasty & Sexual Function Questionnaire (ASFQ) -~     Pre-operative' Version 1.3 11/07/14~      This project is significant in exploring an area of Orthopaedic medicine that has been little~     discussed in the literature. Preliminary results of our questionnaires have already revealed~     patients have a great desire to know how hip replacement will affect sexual function.~     Components of the questionnaire look at details such as: reasonable time frames for returning~     to sexual activity, positions that may be undesirable following replacement and which may~     lead to dislocation, concurrent use of analgesia and psychosexual aspects of total hip~     replacement surgery. The ultimate objective is to provide patients with detailed information~     about what to expect after hip replacement surgery.~   "
97530|NCT02290639|"~     A significant number of veterans of the wars in Iraq and Afghanistan are affected by~     posttraumatic stress disorder (PTSD). The limited reach of effective treatments for PTSD into~     the veteran population is at least partially due to the perceived stigma by service members~     for seeking help in traditional specialty mental health clinics. A comprehensive approach to~     PTSD treatment in a veteran population should provide alternative sources for accessing~     effective psychotherapy treatments. The purpose of study is to conduct a randomized clinical~     trial comparing a brief (four 30-minute sessions delivered over 6 weeks) cognitive-behavioral~     therapy (CBT) protocol designed specifically for use by behavioral health consultants working~     in an integrated primary care setting to a minimal contact 6-week control. The primary~     outcome measure is PTSD symptom relief.~   "
97531|NCT02290626|"~     Study 1: A randomized, crossover trial using elemental or semi-solid diets containing~     contrast medium as a tracer given to bedridden PEG patients. The distribution of the~     administered diets is assessed at the distal esophagus, proximal and distal stomach using a~     plain CT before and 1 hour after the administration.~      Study 2: A randomized, crossover trial using elemental or semi-solid diets containing 13C~     sodium acetate as a tracer given to bedridden PEG patients. 13C breath tests are performed to~     estimate gastric emptying.~   "
97586|NCT02289898|"~     This is a randomized, double blind, 3 arm (1:1:1) study in subjects with 1st-line metastatic~     pancreatic ductal adenocarcinoma.~      The purpose is to test the efficacy and safety of demcizumab, when given in combination with~     gemcitabine and Abraxane® compared to placebo. The administration of gemcitabine and~     Abraxane® is a standard treatment for patients with metastatic pancreatic ductal~     adenocarcinoma.~   "
97587|NCT02289885|"~     The study evaluates the knowledge, attitude and practice about Focused Assessment with~     Sonography in Trauma among emergency medicine practitioners in Poland.~   "
97532|NCT02290613|"~     Trial Design Patients with borderline PAH indicated by borderline mPAP values will be~     included in this single centre study. This clinical investigation is performed as a~     Proof-of-Concept (PoC) investigator initiated trial (IIT) using a prospective, randomized,~     double-blind, parallel group, placebo-controlled, phase IIA clinical study design. On their~     first visit their medical history will be obtained and physical examination will be~     conducted. Moreover, an electrocardiogram (ECG), laboratory testing (NT-proBNP, uric acid and~     other laboratory tests), echocardiography at rest and right heart catheterization will be~     carried out. If patients have been identified within the last 6 months before screening~     investigations by right heart catheterization, the measurements are considered valid as~     baseline investigations and will not be repeated. If patients fulfill the inclusion criteria~     and still suffer from borderline mPAP values they will be invited to join the study. The~     clinical investigations will begin within 28 days. The prospective study will comprise a 6~     months study period (180 ±2 weeks) plus the screening phase up to 28 days and a follow-up~     phase of 30 ±7 days.~   "
97533|NCT02290600|"~     The purpose of this 12 week feasibility study is to see how much more accurate a continuous~     glucose monitor (CGM) might be in individuals with type 1 diabetes if the investigators~     personalize sensor calibrations to the user, based on previous wear.~   "
97534|NCT02290587|"~     In recent years, studies have brought knowledge of the difficulties of social cognition in~     Multiple Sclerosis (MS). The brain tissue alteration at the origin of these difficulties in~     social cognition mechanisms remain poorly understood. Although recent behavioral studies~     indicated social disturbances in many of these patients, functional studies investigating~     specific theory of mind in MS are lacking. The use of new techniques for morphological and~     functional Magnetic Resonance Imaging (MRI) can identify brain activation networks, mapping~     the achievement and tissue integrity may be related to disorders of social cognition and~     cognitive. The investigators propose to study social cognition in MS patients using~     morphological and functional imaging to determine the mechanisms underlying phenomena such as~     cerebral compensation and its relationship with cognitive impairment.~   "
97535|NCT02290574|"~     The current standard treatment of locally advanced rectal cancer is neoadjuvant concurrent~     chemo-radiation therapy (CCRT) followed by total mesorectal excision (TME). Recently,~     laparoscopic surgery is getting substitute open surgery based on the advantages of early~     recovery, short admission, less pain, less blood loss, and little scar without compromising~     oncologic outcomes.~      It is reported that hyperthermia is effective in synthetic (S) phase, Low oxgen pressure,~     acidic, and low perfusion site which are known as radio-resistant. Because of these~     characteristics, it considered as the most valuable radiosensitizer in cancer treatment,~     theoretically. Furthermore, mild hyperthermia (41 to 41.5 ºC) can promote tumor~     reoxygenation.~      Based on those background, the investigators start this prospective study to evaluate the~     efficacy of laparoscopic TME after CCRT with hyperthermia in locally advanced rectal cancer.~   "
97536|NCT02290561|"~     The purpose of this study is to assess how accurately SmartTarget can direct high intensity~     focused ultrasound (HIFU) to a pre-defined area (cancer) in the prostate.~      The current standard methods for treating prostate cancer are directed to the whole gland -~     either surgery to remove it or radiotherapy. An alternative method is focal therapy. This is~     surgery that uses an energy source to ablate the cancer whilst preserving the normal healthy~     tissue.~      Prior to surgery prostate cancer can often be localised using MRI imaging and detailed~     prostate biopsy techniques. The difficulty is that during surgery it is very difficult to~     accurately locate the cancer on the live ultrasound images - to compensate surgeons will~     treat half or a quarter of the prostate to ensure that the cancer is treated. This may cause~     higher rates of side-effects.~      SmartTarget is an MRI to ultrasound fusion device that maps the pre-treatment MRI onto the~     live ultrasound during surgery. It then provides a target for the surgeons to treat during~     the operation.~      The results will measure if the area intended to treat was covered and if how accurate the~     treatment was by comparing the pre-treatment MRI with a 1 week post treatment scan~   "
97537|NCT02290548|"~     The purpose of this study is to determine whether high flow nasal cannula is effective in~     lowering the reintubation rate after extubation for high risk patients in medical intensive~     care unit~   "
97538|NCT02290535|"~     The investigator will determine a compliance of two diagnostic techniques (EIT and Body~     plethysmography) in collective of children and teenagers with obstructive lung disease and a~     matched control group.~   "
97539|NCT02290522|"~     Patients with advanced solid tumors referred to the Phase 1 Unit are offered mapping of GA~     for identification of pts who could benefit from a personalized treatment.~   "
97540|NCT02290509|"~     Randomized, double-blind trial of safety and immunogenicity of Flublok Quadrivalent versus~     Inactivated Influenza Vaccine (IIV4) in 1350 healthy, medically stable adults 18-49 years of~     age. Serum samples for Hemagglutinin Inhibition titers will be determined pre- and 28 days~     post-vaccination. Subjects will be followed for 6 months after vaccination for serious and/or~     medically-attended adverse events.~   "
97541|NCT02290496|"~     This study is a randomized controlled trial that tests the effectiveness of cognitive~     behavior therapy (CBT) for insomnia with comorbid depression in youth aged 12 through 19 who~     have recently begun selective serotonin re-uptake inhibitor (SSRI) antidepressants. CBT is~     compared with a control condition of sleep hygiene education.~   "
97542|NCT02290470|"~     This randomized, pilot study explores the activity of olanzapine with or without delayed~     dexamethasone for the prevention of delayed nausea and vomiting in women with gynecologic~     cancer receiving the combination of carboplatin and paclitaxel. Women treated with this~     regimen are particularly susceptible to chemotherapy-induced nausea and vomiting. Given~     anti-emetic prophylaxis with olanzapine may increase the control of delayed symptoms in women~     receiving carboplatin and paclitaxel.~   "
97588|NCT02289872|"~     The aim of the study was to compare time and success rates of TruView PCD video laryngoscope~     and Macintosh laryngoscope for the pediatric emergency intubation with three airway scenarios~     in a standardized manikin model.~   "
97589|NCT02289859|"~     The purpose of this study is to determine whether undermining during cutaneous surgery~     improves scar cosmesis compared to wound closure without undermining.~   "
97590|NCT02289846|"~     The objectives of this study are to evaluate the safety of IW-9179 in patients with diabetic~     gastroparesis (DGP) and the effect of treatment on the cardinal symptoms of DGP.~   "
97543|NCT02290457|"~     Background: It has been demonstrated that core strength training is an effective means to~     enhance trunk muscle strength (TMS) and athletic performance in youth. However, the role of~     instability with core strength training is unresolved in youth. This study specifically will~     investigate the effects of core stability (CST) compared to core instability strength~     training (CIST) on physical fitness in adolescents.~      Methods: Twenty-seven (14 girls, 13 boys) healthy adolescents (age 14±1 years) will be~     assigned to a CST (n=13) or a CIST (n=14) group. Both training programs will last 6 weeks (2~     sessions/week) and included frontal, dorsal, and lateral core exercises. During CIST, these~     exercises will be conducted on unstable surfaces (e.g., TOGU© DYNAIR CUSSIONS, THERA-BAND©~     STABILITY TRAINER).~      Expected Results: Based on selected results reported in the literature, we hypothesize that~     participants performing CIST as compared to CST will show larger improvements in physical~     fitness tests (i.e., strength, speed, flexibility, coordination, balance) following training.~     Of note, training induced gains in strength, speed, flexibility, coordination, and balance~     are of vital importance for sports performance, everyday activities, and injury prevention.~   "
97544|NCT02290444|"~     The purpose of this study is to evaluate the effect of a medication called Acthar on recovery~     from multiple sclerosis-related relapses that impact cognition.~   "
97545|NCT02290431|"~     The purpose of this study is to evaluate the efficacy and safety of panobinostat in~     combination with bortezomib and dexamethasone in Japanese patients with relapsed/refractory~     multiple myeloma.~   "
97546|NCT02290418|"~     The aim of this study is to compare the relative clinical outcomes between two variants of~     gastric bypass [Roux-en-Y Gastric Bypass (RYGB) or Omega-Loop Gastric Bypass (OLGB)] in~     metabolic surgery candidates with Body Mass Index (BMI) between 35 and 50. The study will~     examine the short and medium term effects of each intervention on weight, obesity~     comorbidities, quality of life and gastroscopy findings.~   "
97547|NCT02290405|"~     The purpose of this study is to learn more about people with insomnia disorder and cognitive~     impairment. Cognitive impairment is difficulty with mental abilities such as thinking,~     knowing and remembering.~   "
97548|NCT02290392|"~     Background:~      - High blood pressure is a common problem. It can cause heart attacks, strokes, and kidney~     failure. It affects African Americans more than other racial groups. Data were collected from~     over a thousand African Americans across the country. The data were put into a database~     (MH-GRID). The data were about genes, diet, sleep, body mass index. They also cover stress~     and access to healthy foods and parks. Researchers at NIH will study these data in new ways.~     They want to learn more about the connection between African Americans and high blood~     pressure.~      Objective:~      - To study MH-GRID data to find the causes of severe high blood pressure and other~     cardio-metabolic problems in people of African ancestry.~      Eligibility:~      - African Americans age 30 55 with severe high blood pressure were used in the MH-GRID study.~     No new participants will be enrolled in this study.~      Design:~      - Researchers will examine data from the MH-GRID study.~   "
97549|NCT02290379|"~     Single-center, randomized, double-blind, placebo-controlled, single ascending dose, safety~     and tolerability study of TNX-201 capsules in healthy volunteers.~   "
97550|NCT02290366|"~     The standard options for men with very low risk prostate cancer include active surveillance~     and the standard treatment options for low risk disease, i.e. radical prostatectomy, external~     beam radiotherapy, and whole gland prostate brachytherapy. The present study seeks to~     evaluate focal brachytherapy using the isotope Cesium 131 to treat patients with low risk~     prostate cancer. The goals of the study are to determine the biochemical disease free~     survival at five years in these patients, as well as to determine the acute and late urinary,~     bowel, and sexual toxicity associated with focal prostate brachytherapy using Cesium 131.~     Patients eligible for the study will be men with histologically confirmed adenocarcinoma of~     the prostate with clinical stage T1c-T2aN0M0, Gleason score ≤3+3=6, prostate specific~     antigen(PSA) <10 ng/ml or a PSA density ≤ 0.15 ng/cc, and ≤ 2 cores positive out of a minimum~     of 12 cores sampled. Additionally, patients must have a single, dominant index lesion on MRI.~     The study is a phase II study. Patients will be followed prospectively. Dosimetry will be~     evaluated post-procedure, and PSAs will be obtained every three months in year one and every~     six months from year two through year five. Urinary, bowel, and sexual morbidity will be~     assessed by patient survey prior to treatment , two weeks, after treatment, at three month~     intervals in year one and at six month intervals in years two through five.~   "
97551|NCT02290353|"~     The investigators have assembled an integrated knowledge/technology/client team to develop a~     novel motion capture-based home therapy program for children with hemiparesis (cerebral~     palsy, acquired brain injury (ABI)) and older persons post-stroke. The investigators society~     needs new approaches to improve the quality of life for millions of Canadians. The method~     proposaed here is to combine low-cost motion capture devices, a bimanual training program,~     social media frameworks such as Facebook Games, and on-line performance sharing between~     therapy clients and with their therapists. The investigators believe that together these~     approaches will yield interventions for people with stroke and children with hemiplegia that~     significantly improve their motivation to continue their exercise programs and thus improve~     their functional ability which will lead to improved quality of life.~   "
97552|NCT02290340|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of an~     extended half-life anti-respiratory syncytial virus (RSV) monoclonal antibody compared to~     placebo when administered to healthy preterm infants.~   "
97553|NCT02290327|"~     The purpose of the this Pilot Trial is to determine the feasibility of conducting a large~     randomized controlled trial (RCT), that aims to examine the efficacy and safety of using~     pantoprazole compared to placebo for stress ulcer prophylaxis in critically ill mechanically~     ventilated patients in the ICU.~   "
97591|NCT02289833|"~     This is a Phase 2, multicenter study designed to evaluate the efficacy and safety of~     trastuzumab emtansine administered as a single-agent in participants with HER2-positive (HER2~     IHC 2+ or HER2 IHC 3+) advanced or metastatic NSCLC. Participants will be treated with~     trastuzumab emtansine administered intravenously at a dose of 3.6 milligrams per kilogram~     (mg/kg) on Day 1 of 21-day cycles until disease progression (as assessed by the~     investigator), unmanageable toxicity, or study termination by the Sponsor, whichever occurs~     first.~   "
97554|NCT02290314|"~     Degenerative lumbar spondylolisthesis is the forward displacement (slip) of one vertebra on~     an adjacent vertebra resulting in narrowing of the spinal canal or compression of the exiting~     nerve roots. It is commonly associated with low back and leg pain, and is a frequent reason~     for spine surgery particularly in individuals over age 65 years. Recently novel minimally~     invasive surgical techniques have heightened public and government interest by touting~     benefits of reduced approached-related morbidity which in turn leads to quicker recovery,~     shorter hospital stay, improved short-term clinical outcomes, and reduced health care cost.~     However, there is no randomized controlled trial evidence to describe the actual advantages~     and disadvantages associated with minimally invasive spinal fusion. This pilot study is a~     randomized control trial comparing minimally invasive MID-line Lumbar Fusion (MIDLF) to~     traditional open posterior lumbar interbody fusion (PLIF) with respect to length of stay,~     approach related morbidity, patient centered outcome measures, and cost-effectiveness in the~     treatment of degenerative lumbar spondylolisthesis.~   "
97555|NCT02290301|"~     The primary objective of the study is to investigate cardiovascular safety of gemigliptin by~     evaluating the time until patients report with major adverse cardiovascular events (MACE) in~     T2DM patients treated with gemigliptin.~      Study patients will be followed up to 4 years until MACE occurrence or until the patient~     drops out of the study or completion of the study. The patient who switches to a~     non-gemigliptin treatment after initiating gemigliptin therapy will be followed until MACE~     occurrence or until the patient drops out of the study or completion of the study.~      The secondary objectives of the study are to evaluate adverse events related as well as~     not-related to MACE in diabetic patients treated with gemigliptin.~   "
97556|NCT02290288|"~     The study is carried out at the Sahlgrenska University Hospital and the patient population~     consists of women referred with symptomatic and bothersome post-hysterectomy vaginal vault~     prolapse at least 1 cm above or beyond the hymeneal remnants. The interventions are either~     vaginal sacrospinousfixation or laparoscopic sacrocolpopexy following randomization to one of~     the types of surgery. The primary outcome is anatomical failure based on clinical assessment.~     Failure is defined clinically, according to the Pelvic Organ Prolapse Quantification system,~     as Ba, C or Bp at the hymen or below on maximum Valsalva maneuver one and two years after the~     surgery. Secondary outcomes are evaluation of continence, sexual function and prolapse~     symptoms based on validated questionnaires 1, 2, 5 and 10 years after the surgery.~   "
97557|NCT02290275|"~     The goal of this research project is to determine the effectiveness of creatine~     supplementation and supported low-load walking exercise for managing systemic inflammatory~     biomarkers and joint symptoms in individuals diagnosed with chronic symptomatic knee~     osteoarthritis. The central hypothesis of this investigation is that creatine supplementation~     and exercise will significantly lower systemic biomarkers of inflammation in patients~     diagnosed with knee osteoarthritis.~   "
97558|NCT02290262|"~     Background: Patients undergoing coronary artery bypass graft surgery often experience a range~     of problems and symptoms related to the procedure and the underlying heart disease.These~     problems include anxiety and depressive symptoms, immobility issues, complications such as~     wound seeping, neck and shoulder pains, interrupted and insufficient sleep. No studies have~     tested a combined intervention on phase 1 rehabilitation in coronary artery bypass graft~     surgery patients. However, randomised trials with either a physical or a mental part have~     been conducted with positive result, but evidence is lacking for a combined intervention.~     Before a large randomised trial was set up a pilot trial was conducted to evaluate the~     feasibility of patient recruitment and intervention: to test the safety and tolerability of~     the intervention by patients and to provide outcome data for sample size calculations. The~     SheppHeartCABG pilot showed trial feasibility, safety and sufficient inclusion rate and high~     compliance with most elements. Outcome data from the pilot trial has been used to sample size~     and power calculation in this randomised clinical trial.~      Objective: The objective of this trial is to investigate the benefits and harms of a phase 1~     comprehensive cardiac rehabilitation programme consisting of an exercise-training and a~     psycho-educative component, including plus treatment as usual in patients who undergo~     coronary artery bypass grafting.~   "
97559|NCT02290249|"~     Background and aims: Glidescope and Airtraq were designed to facilitate intubation and to~     improve teaching intubation. The investigators want to find their efficacy in normal airway,~     tongue edema and face-to-face orotracheal intubation models by novice personal.~      Material and Methods: After Kocaeli Human Researches Ethics Committee approval, thirty six~     medical students who were on the beginning of their third year were enrolled in this study.~     After watching a video about the intubation of one of these devices, they attempted to~     intubate an adult manikin in three different airway models in a random order; first in normal~     airway, second, tongue edema and finally, in an entrapped manikin by face-to-face approach~     with Glidescope or Airtraq. Intubation attempts, insertion and intubation times, success~     rates, Cormack-Lehane grades, need of maneuvers of these devices were recorded.~   "
97560|NCT02290236|"~     The overall aim with this project is to describe the correlation between measured and charted~     saturation after intensive care and also describe the saturation-pattern in these patients.~     The investigators will also correlate post-ICU desaturations measured as oxygen denaturation~     index and complications to pre-ICU obstructive sleep apnea and the STOP BANG screening~     questionnaire.~   "
97561|NCT02290223|"~     Will a primary care-based behavioral intervention for patient activation and engagement and~     self-management, for patients with chronic pain who are taking opioid pain medication, result~     in better patient outcomes than Usual Care?~   "
97562|NCT02290210|"~     The purpose of this study is to assess safety, PK/PD and Urate Lowering Effect of URC102 in~     gout patients with hyperuricemia~   "
97592|NCT02289820|"~     The goal of this study is to evaluate the safety, tolerability and immunogenicity of~     ascending doses of adjuvant in combination with a single dosage level of RSV sF in adults 60~     years or older who are healthy or who have stable, chronic underlying medical conditions.~     This study will also provide preliminary safety and immunogenicity data to support concurrent~     dosing of MEDI7510 with influenza vaccine (IIV), and to assess the safety of MEDI7510 at a~     dose previously assessed in the Phase 1a study.~   "
97563|NCT02290197|"~     Knee dislocation is a serious injury, usually caused by high-energy trauma. It is classically~     defined as complete loss of articular congruence between the femur and the tibia, confirmed~     by radiography. However it is common that the reduction happens spontaneously. For this~     reason, today the investigators also consider a patient suffered knee dislocation in the~     presence of multi-ligament injury involving the posterior cruciate ligament, often in~     association with anterior cruciate ligament, lateral and/or medial ligamentous complex.~      It is considered a serious injury, because both the strong association with vascular and~     nerve damage, which can lead to the need for limb amputation, such as the difficulty in~     obtaining a good functional outcome even after treatment of all ligament injuries.~      The treatment of these injuries aims to achieve knee stability. Joint mobility is often~     sacrificed in the postoperative period, with the use of immobilizations such as casts,~     splints or bracing. Unfavorable clinical outcomes with high rates of stiffness and joint pain~     are very common in these patients. In attempts to improve these results, rehabilitation~     protocols with early range of motion can be employed. However, results may remain~     unsatisfactory, predominantly because of knee instability recurrence.~      Stannard and Zaffagnini proposed a new model for treatment of acute knee dislocations. In~     this model, after multi-ligament reconstruction or repair, a knee articulated external~     fixator is used. Such external fixator allows early and aggressive joint mobility in the~     sagittal plane only. Flexion and extension are permitted, but rotational movements,~     translations in the anterior-posterior plane, lateral (varus) and medial (valgus) openings~     are not allowed. Thus protective stability is ensured for ligament reconstruction procedures.~     Simultaneously the investigators allow immediate joint mobilization, reducing the risk of~     arthrofibrosis, joint stiffness and postoperative ligament laxity.~      There is no consensus regarding the use of hinged external fixator postoperatively in~     multiple ligament reconstruction procedures for treatment of knee dislocations.~      The objective of this study is comparing functional outcomes after ligament reconstruction in~     patients with knee dislocation, with or without the use of hinged external fixator.~   "
97564|NCT02290184|"~     This is a pilot randomized controlled trial intervention to improve lifestyle behaviors~     (physical activity and health diet) for Filipino Americans with type 2 diabetes on metformin.~     If the PilAm Go4Health intervention demonstrates potential efficacy, it may identify~     effective intervention strategies to significantly reduce risks for heart disease risks~     (i.e., metabolic syndrome) in Filipino Americans.~   "
97565|NCT02290171|"~     The overall aim is to evaluate if a familybased intervention, targeting overweight and obese~     children and their parents, has a long-term positive effect on weight development and health~     of the children. The alternative hypothesis to the zero hypothesis is that the children with~     overweight and obesity who participate in a one-year intervention together with their~     parents, both at completion of the six months intervention and at long term follow up will~     have reduced their BMI-for-age z-score (Iso-BMI) and have adopted healthy habits. The~     behavioral models and educational strategies will be tailored (by age, gender etc.) and~     include both general information and practical learning sessions.~   "
97566|NCT02290158|"~     This study evaluates the effects of a finishing protocol in orthodontic outcomes using~     ABO-OGS scores. Patients who finish orthodontic treatment and fulfill the inclusion and~     exclusion criteria receive a treatment using a finishing protocol and their scores are~     compare with 40 patients who don't receive a finishing protocol~   "
97567|NCT02290145|"~     The purpose of this study is to To confirm the predictive value of CCD1 for TPF induction in~     cN2 patients with OSCC~   "
97568|NCT02290132|"~     The clinical application and effect of ATG based myeloablative conditioning regimen after~     allogeneic hematopoietic stem cell transplantation in adult patients with aggressive T-cell~     lymphomas.~   "
97569|NCT02290119|"~     The primary objectives of this study are to understand the effects of soft-tissue balancing~     on Gait, function and rehabilitation potential after sensor-assisted Total Knee Arthroplasty~     and correlate Intra-operative subjective feel with OrthoSensor Outputs~      Secondary objectives are to quantify and observe:~        -  Pain medication use~        -  Swelling~        -  Muscle strength and girth~        -  Gait efficiency~        -  Patient satisfaction~        -  Activity levels, functional return (i.e., back to work, resume normal activities)~        -  Patient perception of a balanced knee~   "
97570|NCT02290106|"~     HMG co-A reductase inhibitors, commonly called statins, are an effective treatment for~     dyslipidemia and atherosclerotic heart disease with proven mortality benefit. While the~     lipid-lowering effects of statins are well-known, other metabolic effects, including effects~     on glucose tolerance and ectopic fat distribution, are less completely understood. Recent~     studies have shown that some statins may increase the risk of diabetes. Further, research has~     suggested that statins may have some benefit in nonalcoholic fatty liver disease (NAFLD), a~     condition associated with obesity that includes increased fat in the liver (steatosis) and,~     in some cases, inflammation and hepatocellular damage (steatohepatitis). Pitavastatin,~     approved by the United States Food and Drug Administration (FDA) in 2009, is the most recent~     statin to enter the market. Unlike most statins, pitavastatin is not primarily metabolized~     through cytochrome P450 (CYP450), and thus has reduced potential for interactions with other~     medications that are metabolized by CYP450. Previous studies have suggested that pitavastatin~     may be neutral to glucose homeostasis and may improve hepatic lipid. Neither of these effects~     has been proven definitively, however, and the current proposal aims to characterize in~     detail the effects of pitavastatin on glucose homeostasis, hepatic steatosis, and~     steatohepatitis.~   "
97571|NCT02290093|"~     The success of colonoscopy is closely related to the quality of colonic preparation. However,~     data regarding colonoscopy preparations in the elderly (65 years older) are scarce.~     Split-dosage cathartic bowel preparation are currently suggested, whereas supporting evidence~     is lacking in this particular group of patients. Moreover, patient tolerability is a key~     factor for success of bowel preparation in the aged people.~      The purpose of this study is to compare the bowel cleansing efficacy and patient compliance~     of following bowel preparation methods prior to elective outpatient colonoscopy in the~     elderly: (1) standard preparation of 4 liters (L) PEG-3350 solution on the night before~     colonoscopy, (2) split-dose of 4L PEG-3350 solution, and (3) split-dose of reduced volume~     [2L] PEG-3350 containing ascorbic acid solution.~   "
97593|NCT02289807|"~     Currently, concurrent chemoradiotherapy with/without sequential chemotherapy is the standard~     treatment modality for intermediate risk NPC (stage II and T3N0M0) according to the National~     Comprehensive Cancer Network guideline. However these recommendations were based on the~     evidence in the two-dimensional conventional radiotherapy (2DCRT) era. The introduction of~     intensity-modulated radiotherapy (IMRT) in NPC treatment has brought substantial better~     treatment outcomes than 2DCRT. It has been questioned whether additional concurrent~     chemotherapy is still necessary for intermediate risk NPC within the excellent framework of~     IMRT. hus, we jointly conduct the first non-inferior randomized trial to determine the value~     of concurrent chemotherapy with cisplatin for intermediate risk NPC patients treated with~     IMRT. Given the results of clinical studies mentioned above, we decide to adopt the~     concurrent regimen to be cisplatin 100 mg/m2 on day 1, 22, 43~   "
97572|NCT02290080|"~     Oxygen treatment is widely used in acutely ill patients, both pre-hospital and in hospital.~     The indication for oxygen is sometimes unquestionable, such as in many hypoxic patients, but~     in other situations its use is more of a practise and much less based on scientific evidence.~     In particular, oxygen treatment is routinely used in patients with a suspected heart attack~     and variably recommended in guidelines, despite very limited data supporting a beneficial~     effect. Indeed, a few studies even indicate that oxygen treatment might be harmful.~      Immediate re-opening of the acutely blocked artery to the heart muscle is the treatment of~     choice to limit permanent injury. However, the sudden re-initiation of blood flow achieved~     with primary percutaneous coronary intervention (PCI), the reopening and stenting of the~     blocked vessel, can give rise to further endothelial and myocardial damage, so-called~     reperfusion injury. Ischemia and reperfusion associated myocardial injury (IR-injury)~     involves a wide range of pathological processes. Vascular leakage, activation of cell death~     programs, thrombocytes and white blood cells leading to extended inflammation and formation~     of clots are examples of those effects.~      The role of oxygen treatment on these pathological processes, on the extent of IR-injury and~     the final infarct size in patients with acute myocardial infarctions (AMI) has not previously~     been studied.~      In an ongoing national multicentre, randomized, registry based clinical trial, the DETO2X-AMI~     trial (NCT01787110), the effect of oxygen on morbidity and mortality in ACS patients is being~     investigated.~      The present DETO2X-biomarkers study is a substudy of the DETO2X-AMI trial, evaluating the~     effect of oxygen treatment on biological systems involved in the pathogenesis of reversible~     and irreversible myocardial damage and cell death in ACS.~   "
97573|NCT02290067|"~     The aim of this test is to determine the system accuracy and user performance evaluation of~     three Blood Glucose Monitoring systems. For system accuracy evaluation the measurement data~     should cover the whole range of glucose concentration which could usually be expected in~     patients with diabetes mellitus.~   "
97574|NCT02290054|"~     Urinary retention is a common complication of epidural analgesia. Auriculotherapy could~     prevent this complication. This study will be performed among men receiving thoracic epidural~     analgesia after thoracic surgery.~   "
97575|NCT02290041|"~     Phase I/IIClinical trial, proof of concept, double blind, and placebo-controlled, randomized~     2:1 (MSCs: placebo), total sample size is 15 subjects~   "
97576|NCT02290028|"~     The QP ExCELs study is designed to confirm safety and efficacy of the BIOTRONIK Sentus OTW QP~     left ventricular leads to satisfy FDA requirements for regulatory approval of the leads in~     the US. The Sentus OTW QP leads received FDA approval on May 4, 2017.~      Long-term safety of the BIOTRONIK Sentus OTW QP left ventricular leads will be confirmed~     during the ongoing post approval phase (US sites only).~   "
97577|NCT02290015|"~     This trial was a randomized, single-blinded, sham-controlled study, in which the patients~     were blinded to treatment assignment. First, all candidates underwent audiological testing of~     hearing thresholds, tympanometry and stapedius reflex tests. The patients who were selected~     for the study were interviewed to assess and evaluate their condition and then underwent a~     detailed physical examination that included a complete otorhinolaryngologic examination and a~     complete blood test. Then, the subjects were randomized to undergo true or sham ACP. Seven~     days before (baseline) and seven days after twelve acupuncture (ACP) sessions (up to six~     weeks), which were performed twice a week, all participants underwent 99mTc-ECD SPECT~     scanning and completed the Portuguese version of the Tinnitus Handicap Inventory (THI), the~     Visual Analogue Scale (VAS), Hamilton Anxiety Scale (HAS) and the Beck Depression Inventory~     (BDI). The purpose of this study was to integrate the neuroscience research findings with the~     clinical research on tinnitus. Thus, a randomized, single-blinded, placebo-controlled trial~     was implemented to investigate the effect of ACP as a treatment for tinnitus using~     ethylcysteine dimer single-photon emission computer tomography (99mTc-ECD SPECT).~   "
97578|NCT02290002|"~     The purpose of this study is to compare the effect of oral Calcium Dobesilate versus costing~     in the prevention of ovarian hyperstimulation syndrome (OHSS) in high-risk women underwent~     intracytoplasmic sperm injection (ICSI).~   "
97579|NCT02289989|"~     This study is designed to evaluate and compare the efficacy of 3% oregano extract ointment~     prepared in aqueous solution versus 1% hydrocortisone ointment, a standard treatment, in~     decreasing the inflammation associated with mild to moderate atopic dermatitis. We plan to~     recruit 40 patients on the ages comprised between 2 and 17 years old and the study duration~     for each of the patient is 1 month.~   "
97580|NCT02289976|"~     The purpose of this study is to determine if surgical angiogenesis performed in talar~     avascular necrosis by free microvascular bone grafts from the medial femoral condyle is a~     superior technique compared to core decompression and nonvascularized osseous autografts.~   "
97581|NCT02289963|"~     Primary Objective:~      To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as~     add-on therapy to stable maximally tolerated daily statin therapy with or without other~     lipid-modifying therapy (LMT) in comparison with placebo after 24 weeks of treatment in high~     cardiovascular risk participants with hypercholesterolemia in South Korea and Taiwan.~      Secondary Objectives:~        -  To evaluate the effect of alirocumab in comparison with placebo on LDL-C after 12 weeks~          of treatment.~        -  To evaluate the effect of alirocumab on other lipid parameters: apolipoprotein B (Apo~          B), non high-density lipoprotein cholesterol (non-HDL-C), total cholesterol (TC),~          lipoprotein (a) (Lp [a]), high-density lipoprotein cholesterol (HDL-C), triglycerides~          (TGs), and apolipoprotein A-1 (Apo A-1).~        -  To evaluate the safety and tolerability of alirocumab.~        -  To evaluate the development of anti-alirocumab antibodies (ADA).~   "
97582|NCT02289950|"~     MORAb-003-011 is a global, multicenter, double-blind, randomized placebo-controlled study to~     assess the safety and efficacy of farletuzumab in combination with standard chemotherapy in~     subjects with low CA125 platinum sensitive ovarian cancer in first relapse.~   "
97583|NCT02289937|"~     The purpose of this study was to evaluate the analgesic efficacy of the nervus cutaneous~     femoral lateralis (NCFL) blockade on postoperative pain after total hip replacement surgery.~     The NCFL-block is a pure sensory block. We hypothesized that the NCFL-block would reduced the~     postoperative pain without delaying mobilization.~   "
97584|NCT02289924|"~     The main objectives of this non-interventional cohort field study are to evaluate~     effectiveness of Eylea and to describe follow-up as well as treatment patterns in patients~     with wAMD (wet age-related macular degeneration) in routine clinical practice in Italy for a~     study population of naïve patients~   "
97585|NCT02289911|"~     Training paramedics in new skills via classroom-based teaching has inherent costs and time~     constraints. The investigators sought to evaluate whether web-based didactics result in~     similar knowledge improvement and retention of FAST (Focused Assessment with Sonography for~     Trauma) compared with the traditional method.~   "
97595|NCT02289781|"~     A randomized, controlled clinical trial is designed to analyze the wear of enamel by opposing~     polished monolithic zirconia crowns and by the polished veneer surfaces of metal-ceramic~     crowns. This single-blind pilot study will involve a total of 30 teeth that require full~     coverage crowns that oppose natural antagonist teeth.~      The objectives of this research are to test the following hypotheses: (1) differences between~     mean wear of antagonist enamel by polished monolithic zirconia crowns and by the polished~     veneer surface of metal-ceramic crowns are statistically significant; (2) differences between~     mean wear of antagonist enamel by opposing polished monolithic zirconia crowns and enamel by~     opposing enamel are statistically significant; and (3) differences between mean antagonist~     wear of enamel by opposing polished veneer surfaces of metal-ceramic crowns and enamel by~     opposing enamel are statistically significant.~   "
97596|NCT02289768|"~     The main purpose of this vehicle-controlled study is to determine the efficacy and safety of~     a solution of Actikerall® (containing 5-fluorouracil 0.5% and salicylic acid 10.0%) in the~     field-directed treatment of grade I-II actinic keratosis, when it is applied to the affected~     area once daily for 12 weeks.~      A secondary objective of this study is to evaluate the efficacy of Actikerall® solution on~     subclinical actinic keratosis lesions in a subset of patients.~   "
97597|NCT02289755|"~     The purpose of this study is to evaluate the effect of ALLN-177 to reduce urinary oxalate~     excretion in patients with recurring kidney stones and enteric or idiopathic hyperoxaluria.~   "
97598|NCT02289742|"~     The purpose of this study is to evaluate the pre lens tear film characteristics of DAILIES®~     Aqua Comfort Plus® Multifocal (DACP MF) and Toric (DACP Toric) compared to DAILIES® Aqua~     Comfort Plus® Sphere (DACP) daily disposable contact lenses over 12 hours of lens wear.~   "
97599|NCT02289729|"~     Patient reported outcomes (PRO) have become an important endpoint assessed in clinical~     trials. It is important to understand the relationship between medication and patients'~     symptomatology, quality of life and wellbeing. We predict Duodopa will significantly improve~     quality of life and emotional wellbeing compared to baseline in patients with advance~     Parkinson disease (APD) not well controlled with conventional treatment.~   "
97600|NCT02289716|"~     The purpose of this study is to demonstrate the efficacy, safety, and tolerability of~     fulranumab as Monotherapy compared with placebo in participants with signs and symptoms of~     osteoarthritis of the hip or knee that are not adequately controlled by current pain therapy.~   "
97601|NCT02289703|"~     The purpose of this study is to assess the pharmacokinetics (the study of the way a drug~     enters and leaves the blood and tissues over time) and pharmacodynamics (the way a drug may~     change body function) of a single 15-milligram (mg) dose of rivaroxaban in both healthy~     participants with a creatinine clearance (CLcr) greater than equal to (>=) 80 milliliter per~     minute (mL/min) and clinically stable participants with end-stage renal disease (ESRD) on~     maintenance hemodialysis (a method used to remove waste material from the blood when the~     kidneys are unable to do so).~   "
97602|NCT02289690|"~     The study seeks to assess the efficacy of veliparib (ABT-888) in combination with carboplatin~     and etoposide in participants with extensive disease small cell lung cancer (ED SCLC). ED~     SCLC is defined herein as any SCLC except a disease confined to the hemithorax of origin,~     with or without the involvement of regional lymph nodes, including ipsilateral and~     contralateral mediastinal, ipsilateral and contralateral mediastinal, and ipsilateral~     supraclavicular nodes~   "
97603|NCT02289677|"~     We hypothesized that the video-laryngoscopes are beneficial for intubation of pediatric~     manikins while performing CPR. In the current study, we compared effectiveness of two~     video-laryngoscopes (the Coopdech video Laryngoscope portable VLp-100 and the Flexible~     Videoendoscope: ATMOS Scope) and optical-laryngoscope (the AirTraq) during resuscitation with~     uninterrupted chest compressions using an child manikin.~   "
97604|NCT02289664|"~     We hypothesized that the video-laryngoscopes are beneficial for intubation of pediatric~     manikins while performing CPR. In the current study, we compared effectiveness of three~     video-laryngoscopes and Macintosh (MAC) laryngoscopes during pediatric resuscitation with and~     without chest compressions using an child manikin.~   "
97605|NCT02289651|"~     We hypothesized that the Venner videolaryngoscope (A.P. Advance™) is beneficial for~     intubation of pediatric manikins while performing CPR. In the current study, we compared~     effectiveness of the Venner videolaryngoscope (A.P. Advance™) and MIL laryngoscopes in child~     resuscitation with and without CC.~   "
97606|NCT02289638|"~     We hypothesized that the Intubrite Video Laryngoscope System VLS 6600 is beneficial for~     intubation of pediatric manikins while performing CPR. In the current study, we compared~     effectiveness of the Intubrite and MIL laryngoscopes in child resuscitation with and without~     CC.~   "
97607|NCT02289625|"~     Abstract~      Obstructive sleep apnea syndrome (OSA) is characterized by complete or partial collapse of a~     narrowed pharynx and it's associated with reduction in cerebral blood flow, cardiovascular~     disease, and neuropsychological deficits and reduces survival. In patients with AOS~     structural, metabolic and hypoperfusion cerebral were associated not only with physiological~     functions but also with attention and executive function. There is a higher association~     between apnea hypopnea index and Mini-Mental State Examination in individuals with the exon 4~     of APO E gene, indicating that exon 4 of APO E gene confers an increased risk for cognitive~     decline in individuals with sleep apnea. The analysis of presence and consequences of OSA in~     cerebral structure, inflammation and neurovascular control can permit a better investigation~     of abnormalities in these individuals and implement interventions to reduce the risk of~     development of cognitive and cardiovascular impairment. The non-pharmacological intervention~     through exercise training can represent an important strategy for improvement in cerebral~     alterations, cognition and reduction in sleep apnea index. The purpose of present study is~     investigate the volume and metabolism cerebral, neurovascular control, cognition and exon 4~     of APO E gene and their~   "
97608|NCT02289612|"~     The purpose of this study is to determine the specific properties of a variety of dietary~     fibres that lead to different postprandial glycemic and satiety responses in individuals at~     risk for type 2 diabetes. This is accomplished by utilizing a variety of dietary fibres that~     demonstrate a wide range of properties in a pudding product, and by examining the ability of~     each of these to limit gastric emptying, limit glucose absorption, limit insulin secretion,~     and improve satiety, versus a low fibre control product.~   "
97609|NCT02289599|"~     This study will be a single-center, single dose, randomized, double-blind, placebo-controlled~     study in healthy Japanese male subjects. The study will consist of 2 parts: Part A (young~     subjects) and Part B (elderly subjects). In Part A sequential cohorts of subjects will be~     treated with single ascending doses of E2307. The maximum tolerated dose (MTD) will be~     determined in Part A. Part B will be initiated after Part A is completed. In Part B one~     cohort of healthy elderly subjects will be treated with a single dose of E2307 at one dose~     level below the MTD. In part A, a total of 56 subjects will be enrolled into 7 cohorts~     sequentially and randomized 3:1 to receive either E2307 (1 mg, 3 mg, 10 mg, 30 mg, 100 mg,~     200 mg, or 300 mg) or placebo. In part B, a total of 8 subjects will be randomized, 6~     subjects to a single dose of E2307 and 2 subjects to placebo.~   "
97610|NCT02289586|"~     To evaluate the effect and safety of noninvasive ventilation assisted interventional~     bronchoscopy for hypoxemia patients with central airway stenosis.~      With the sedation and analgesia, noninvasive ventilation assisted interventional bronchoscopy~     for hypoxemia patients with central airway stenosis is safe and effective, carries high~     satisfaction rate.~   "
97611|NCT02289573|"~     Chronic obstructive pulmonary disease(COPD) is a common disease among people. Acute~     exacerbation of chronic obstructive pulmonary disease(AECOPD) is the acute and aggravating~     phase of COPD which may lead to respiratory failure. Mechanical ventilation is a very~     important therapy for those patients,but traditional ventilation modes have some defects, so~     investigators need to find new modes to solve these problems. In this study, the~     investigators compare neurally adjusted ventilatory assist (NAVA) and PSV to observe the~     effects on AECOPD patients' air distribution and dead space to determine if NAVA is a more~     appropriate ventilation mode for AECOPD patients.~   "
97612|NCT02289560|"~     The objective of this prospective, multi site, single-arm study is to capture the efficacy of~     treatment using the ExAblate Transcranial System and to further demonstrate safety in~     medication-refractory tremor in patients with essential tremor (ET).~   "
97613|NCT02289547|"~     XELOX regimen had a more favorable toxicity profile compared to cisplatin for patients with~     advanced gastric cancer. The safety profile of oxaliplatin makes it an ideal candidate for~     combination therapy. However, oxaliplatin induce sensory neuropathy, a cumulative,~     dose-related toxicity. It may therefore be possible to devise capecitabine maintenance~     regimen which achieves maximum treatment effect before cumulative neurotoxicity appears. We~     study that randomized Phase III study of Xelox (Capecitabine plus Oxaliplatin) followed by~     maintenance Capecitabine or Observation in the gastric cancer patients of stable disease~     after 6 cycle 1st line of XELOX chemotherapy .~   "
97614|NCT02289521|"~     This study aims to evaluate the effect of stimulation of prefrontal regions on language~     performance (e.g. word translation and picture naming).~      During the language tests, cortical activity will be registered using electroencephalography~     (EEG) which will provide supplementary information about the cerebral processus involved in~     language production and management of two languages in bilingual subjects.~   "
97615|NCT02289508|"~     Objective:~      The Ultrasonic Cardiac Output Monitor (USCOM) is a non-invasive, quantitative method for~     measuring and monitoring cardiovascular haemodynamic parameters in patients. The aims of this~     study are:~        1. To investigate whether USCOM-derived haemodynamic parameters such as Cardiac output~          (CO), inotropy and oxygen delivery (DO2) have a role in the diagnosis of patients with a~          compensated heart failure syndrome (cHFS) or acute decompensated heart failure syndrome~          (adHFS)~        2. To investigate whether USCOM-derived haemodynamic parameters such as CO, inotropy and~          DO2 correlate with heart failure staging, especially New York Heart Association (NYHA)~          class and American Heart Association (AHA) stage.~        3. To investigate whether USCOM-derived haemodynamic parameters such as velocity time~          interval (vti), stroke volume (SV), CO, SV index (SVI), CO index (CI), inotropy and DO2~          correlate with ejection fraction.~        4. To investigate whether USCOM-derived haemodynamic variables may be used as prognostic~          indicators of 30-day, 6-month and 1-year Major Adverse Cardiac Events (MACE).~        5. To evaluate the agreement between hemodynamic measurements obtained using the Ultrasonic~          Cardiac Output Monitor (USCOM®; USCOM Ltd., Sydney, Australia), and reference standards~          as determined by 2 Dimensional echocardiography (2D-echo) measurements in groups of~          haemodynamically stable and unstable adult patients.~      Design:~      This prospective observational cohort study will be conducted in the Prince of Wales Hospital~     in Hong Kong.~      Setting and Subjects:~      Patients will be screened and recruited from adult patients either scheduled for elective~     2D-echo at a cardiology clinic at the Prince of Wales Hospital, or attending the emergency~     department at the Prince of Wales Hospital.~      Interventions:~      Haemodynamic measurements made using the USCOM and 2D-echo will be compared. In order to~     assess inter-observer variability, a second, blinded operator will repeated 15% of scans.~   "
97616|NCT02289495|"~     The proposed study, 200207 is a double blind, placebo controlled, single and repeat dose~     escalation study to investigate the safety, tolerability and PK of GSK2838232 alone and when~     co-administered with RTV 100 milligram (mg) Once daily (QD). This study will enable future~     clinical development of GSK2838232 in healthy subjects and in a Phase IIa proof of concept~     study in Human Immunodeficiency Virus (HIV) infected patients. This study is a single and~     repeat dose escalation study and will be conducted as two Parts. Part A will evaluate~     GSK2838232 20 mg and 50 mg administered QD for 8 days and Part B will evaluate GSK2838232 10~     mg, 20 mg, and 50 mg, co-administered with RTV 100 mg, QD for 11 days. The extended period of~     dosing is to account for the longer terminal phase half-life of GSK2838232 when given with~     RTV. Dose cohorts will be enrolled sequentially; enrollment into a cohort will commence~     following review of interim PK and safety data from at least 4 subjects in the preceding~     cohort. Subjects in both parts will have a screening visit within 30 days prior to first dose~     and a follow-up visit 7-14 days after the last dose. Maximum duration of study participation~     will be approximately 7 weeks. Approximately 40 healthy subjects will be enrolled, 8~     subjects/cohort. Subjects will be randomized 3:1 to receive GSK2838232 or placebo.~   "
97630|NCT02289313|"~     Approximately one third of the children and adolescents in the United States are either~     overweight or obese. Childhood obesity disproportionately affects specific racial and ethnic~     groups and households with low socioeconomic status and low parental education. The~     Alternative Learning Center (ALC) within Rochester School District 535 provides viable~     educational options for students who are experiencing difficulty in regular educational~     systems. A greater proportion of students at ALC are minorities, qualify for free and reduced~     lunch and receive special education services. These children are likely to have unique~     barriers to physical activity and healthy eating.~      Specific Aims:~      Aim 1: Examine the association between BMI and ethnic/ socioeconomic variables and behaviors~     related to physical activity and eating in ALC students.~      Aim 2: Develop an age and culturally appropriate on-site program that promotes healthy~     lifestyle.~   "
97631|NCT02289300|"~     The purpose of this study is to determine whether an investigational drug DCB-BO1202 is~     effective and safe in the treatment of liver fibrosis in HBV patients having experienced~     intermediate stage hepatocellular carcinoma (HCC)~   "
97617|NCT02289482|"~     This study investigates the safety, tolerability and PKs of GSK2838232 with and without~     Ritonavir, and to evaluate different formulations of GSK2838232 in healthy subjects. This~     study will evaluate higher single and RTV boosted doses to support continued clinical~     development of GSK2838232 at clinically relevant doses, and subsequently in those infected~     with HIV in a dose ranging phase 2 study. The study is conducted in 2 parts: Part A and Part~     B, study Part A and Part B may be conducted in parallel. Approximately 20 healthy subjects~     will be enrolled into the study, 8 in Part A and 12 in Part B. Part A is a double-blind,~     randomized, placebo-controlled, 4-period, single dose escalation design. Subjects will be~     randomized 3:1 to receive GSK2838232 or placebo. Subjects randomized to placebo will receive~     placebo in all four periods. Following completion of Period 2 PK assessments at 96hr~     post-dose, subjects will begin daily dosing of RTV 100mg for a total of 26 days.~      Part B is a randomized, open-label, unbalanced, 3-period, cross-over design; subjects will be~     randomized 1:1 to each sequence. The relative bioavailability of single 100mg doses of powder~     in a bottle (PIB) active pharmaceutical ingredient (API) of GSK2838232 versus PIB spray-dried~     dispersion (SDD) will be assessed. A single dose of GSK2838232 will co-administered on the~     10th day of RTV dosing; RTV dosing will continue for an additional 4 days (total of 14 days).~     Subjects will have a screening visit within 30 days prior to first dose and a follow-up visit~     7-14 days after the last dose.~   "
97618|NCT02289469|"~     Medication safety is an important concern in hospital Emergency Departments (EDs), which~     provide approximately 136 million patient visits annually in the US. An accurate list of the~     patient's medications is often needed to inform medical decision-making. Moreover, health~     care facilities are required to provide patients with an accurate, reconciled list of their~     medications upon completion of the visit. However, for 37-87% of patients in the ED, errors~     are present in the documented medication list, and patients often leave without an updated~     list of their medications or a good understanding of their self-care instructions. This~     increases the risk of harmful adverse drug events. Health disparity populations, who are more~     likely to seek care in EDs and who more often have difficulty providing a complete medication~     history, are disproportionately affected.~      Health information technology has the potential to improve medication safety in this setting.~     PictureRx is an internet-based platform designed to improve medication management in~     vulnerable populations. It allows users to generate illustrated medication lists in an~     easily-understood, patient-centered format, in either English or Spanish. The investigators~     have developed a process for importing prescription fill data from the Surescripts Medication~     History service, which covers 96% of US pharmacies, into the PictureRx platform. The~     investigators are developing a mobile tablet PC-based medication history platform that~     receives and processes the Surescripts data, as well as prompts verification and additional~     information about the medication regimen.~      This trial will assess the effect of the PictureRx medication history platform on the~     accuracy and efficiency of the medication reconciliation process, as well as patient~     understanding and satisfaction, in hospital Emergency Departments.~   "
97619|NCT02289456|"~     4 cycles of induction treatment with nab-paclitaxel and carboplatin followed by~     nab-paclitaxel monotherapy for those subjects who are progression free at the end of 4~     cycles.~   "
97620|NCT02289443|"~     In this study, the investigators propose a 10-year follow up study of participants in a~     randomized clinical trial to compare the oral health-related quality of life (OHRQoL), as~     well as general and related satisfaction of conventional complete dentures fabricated using~     two different procedures.~   "
97621|NCT02289430|"~     The purpose of this study is to compare the drug interaction of pharmacokinetics of~     rosuvastatin and ezetimibe.~   "
97622|NCT02289417|"~     The purpose of the study is to evaluate the clinical efficacy, safety and tolerability of~     apremilast (30 mg twice daily [BID] and 40 mg BID), compared with placebo, in subjects with~     active Ulcerative Colitis (UC).~   "
97623|NCT02289404|"~     The purpose of this study is to Evaluate food effect of NVP-1203 in healthy Korean male~     adults.~   "
97624|NCT02289391|"~     The study try to illustrate the possible mechanisms of tending to induce airway spasms and~     the impact of dexmedetomidine on inflammatory reaction in general anesthesia patients with~     asthma，by detecting the differences of plasma inflammatory factor interleukin(IL)-4, IL-5,~     IL-13, IL-17, IL-33, MBP and immunoglobulin E(IgE) levels between asthma patients and~     non-asthma patients.~   "
97625|NCT02289378|"~     This is an open-label, phase II study to evaluate the efficacy and safety of biweekly~     docetaxel, Oxaliplatin and de Gramont regimen on unresectable gastric adenocarcinoma in the~     first-line therapy.~   "
97626|NCT02289365|"~     This trial is designed as a multicenter, double-blinded, randomized, placebo controlled study~     to assess the safety and efficacy of JBM-TC4 for the prevention and treatment of acute~     radiation-induced dermatitis in breast cancer patients receiving radiotherapy.~   "
97627|NCT02289352|"~     A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled, Parallel-Design Study to~     Evaluate the Safety and Therapeutic Equivalence of Brimonidine Topical Gel, 0.33% (Watson~     Laboratories, Inc., USA) to Reference Product Mirvaso® (brimonidine) topical gel, 0.33%~     (Galderma Laboratories, L.P., USA) in Patients with Moderate to Severe Facial Erythema~     Associated with Rosacea~   "
97628|NCT02289339|"~     The purpose of this registry is to document the everyday practice in our centers with minimal~     invasive treatment of patients with aortic valve disease who were considered suitable for~     transfemoral aortic valve implantation by heart team.~   "
97629|NCT02289326|"~     Purpose~      This study is an 'N-of-one' observational study focusing on individuals with a hereditary~     predisposition to cancer due to a genetic mutation in the TP53 gene. An individual with this~     mutation has a >90% chance of developing many different forms of cancer in their lifetime.~     Since germline TP53 gene mutation carriers are highly susceptible to cancer, cancer~     prevention strategies and early cancer detection strategies are crucial. Unfortunately, the~     current standard of care for monitoring germline TP53 gene mutation carriers for early signs~     of cancer is yearly MRI scans and intermittent blood draws. Villani et al. showed that~     standard monitoring is inadequate and introduced a more sophisticated protocol for early~     cancer detection. We extended the Villani et al. protocol to include a number of markers for~     early detection and are currently vetting their utility, in terms of their inherent~     variability, patient tolerability of frequent interrogation, and ability to show changes that~     might indicate a need for further examination.~      In addition to the markers being collected, important covariate information, such as diet,~     sleep, and activities are being collected (via, e.g., wearable wireless devices) in order to~     take them into account in assessing the levels of the markers at a single data collection~     time or over time. One important aspect of the protocol is to identify changes, rather than~     specific levels, in marker status over time for an individual that might be indicative of~     tumor formation, essentially exploiting the concept of 'personalized thresholds' discussed by~     Drescher et al.~      If any indication of the presence of a cancer, tumorigenic process, or general sign of~     ill-health is observed, the protocol calls for a discussion of the findings among the~     research team, followed by a discussion between the clinical lead on the research team and~     the primary care provider and/or specialists overseeing a participating patient's care,~     possible validation of the assay(s) motivating the discussions, and a decision on how to~     intervene on the part of the primary care provider and/or specialists.~   "
97685|NCT02288585|"~     Double-blind, randomised, placebo-controlled, parallel group study with two intervention~     arms. The study will be conducted in 150 subjects and the primary objective is to show a~     fasting LDL-cholesterol and triglyceride lowering effect of plant sterols in subjects with~     established type 2 diabetes mellitus and subjects at high risk of developing type 2 diabetes.~   "
97632|NCT02289287|"~     Stroke is defined as a sudden vascular accident that causes brain damage and neurological~     impairment. Literature shows that a stroke has a negative effect on participation.~     Self-Management (SM) is defined as health promotion and education programs used mostly for~     people with chronic diseases, which aim at helping patients to maintain a feeling of~     wellness. The primary aim of this study is to assess the effectiveness of a group-based SM~     program for post-stroke patients in a community setting, and its contribution to improving~     participation, compared to standard care.~   "
97633|NCT02289274|"~     The purpose of this study is to compare the pharmacokinetics of NVP-1203 and coadministration~     of aceclofenac and eperisone HCl SR.~   "
97634|NCT02289261|"~     The purpose of this study is to determine whether dexmedetomidine added to morphine is~     effective in the treatment of chronic cancer pain.~   "
97635|NCT02289248|"~     Subjects with depressive episodes will be recruited to undergo a brief 2 week course of IV~     infusions of ketamine in combination with cognitive behavioral therapy for 8 weeks.~   "
97636|NCT02289235|"~     The investigators want to evaluate the effects and safety of ginger in treatment of~     nonalcoholic fatty liver disease (NAFLD).~   "
97637|NCT02289222|"~     This is an open label trial of Anti PD1/MD-3475, Pomalidomide and dexamethasone. The study~     will use standard (FDA approved) doses for both pomalidomide and dexamethasone. The~     experimental drug Anti PD-1 (MK 3475) given on days 1 and 14.~   "
97638|NCT02289209|"~     Eligible participants with locoregional inoperable recurrence or second primary squamous cell~     carcinoma of the head and neck will be treated with reirradiation combined with anti-PD-1 mAb~     MK-3475 (generic name: pembrolizumab, trade name Keytruda®).~   "
97639|NCT02289196|"~     Patients with histologically proven malignancy with documented disease control (objective~     response or stable disease) or Not Evaluable Disease (NED) expectancy > 6 months; only~     HLA-A*02 positive patients.~      The primary objective of the trial is to compare safety and tolerability of four different~     doses of Vx-006. The secondary objective is to compare immunogenicity of four different doses~     of the Vx-006.~   "
97640|NCT02289183|"~     The purpose of this study is to explore the clinical application value of modified~     delta-shaped gastroduodenostomy in totally laparoscopic surgery for distal gastric cancer.~   "
97641|NCT02289170|"~     The purpose of this study is to verify the efficacy and safety of heating and cooling~     combination therapeutic device (OCH-S100) for patients with chronic low back pain (LBP).~   "
97642|NCT02289157|"~     The investigators propose a prospective, randomized trial evaluating the use of negative~     pressure wound therapy (NPWT) with high risk obstetrical patients. The investigators~     hypothesize that negative pressure wound therapy will decrease the wound complications in~     these patients. The investigators aim to look at all wound complications such as infection~     and disruption and will be using Prevena incision management system for our NPWT device .~   "
97643|NCT02289144|"~     This is an, open-label, protocol designed to evaluate the activity of targeted therapy in~     anaplastic/undifferentiated thyroid cancer. Arm A will evaluate ATC/UTC with mutations or~     rearrangements detected in the ALK gene.~      There is no effective treatment for anaplastic thyroid cancer in the locally recurrent or~     metastatic setting. Ceritinib will be administered to the patient until disease progression~     by RECIST 1.1, unacceptable toxicity, withdrawal of consent, or discontinuation of the trial~     for any other reason.~      The primary focus of this arm of the protocol is identifying ceritinib's activity in~     anaplastic or undifferentiated thyroid cancer patients. Those patients with mutations~     identified in their ALK gene by sequencing their tumor samples, or with the established ALK~     abnormalities will be treated with ALK-inhibitors. These include the Ventana assay and Vysis~     FISH probe, and patients with tumors positive by this assay will also be considered eligible~     for therapy on the trial.~      Therapeutic Portion:~      ARM A: ALK Abnormality IND Ceritinib 750 mg orally daily on Day 1 Continue q4 weeks x 2~     cycles~      Primary Endpoint: The development of progression; new recurrence or distant metastasis, as~     well as enlargement of an existing metastasis on radiographic imaging.~      Secondary Endpoints:~        1. Overall response rate for patients treated with ceritinib as part of the study.~        2. Death of study participant due to any cause.~   "
97644|NCT02289131|"~     Tooth brushing for patients with breathing tubes is routinely provided by the bedside nurse~     as part of clinical care. The purpose of this study is to determine how often tooth brushing~     should occur for adult patients with breathing tubes (mechanical ventilation), balanced with~     equivalence and safety.~   "
97645|NCT02289118|"~     The central goal of this study is to determine and compare the similarities and differences~     in regional brain uptake of [18F]T807 in patients with typical Alzheimer's Disease (AD),~     Posterior Cortical Atrophy (PCA), and Logopenic Variant of Primary Progressive Aphasia~     (lvPPA). The investigators will correlate patterns of [18F]T807 binding with magnetic~     resonance imaging (MRI)-based regional volumetric and cortical thickness measures. If~     cerebral spinal fluid (CSF) samples are not available, patients may be asked to get an~     optional lumbar puncture (LP) for additional comparisons. The investigators will recruit 20~     participants, 45-70 years old, with clinical evidence of young onset focal dementia.~   "
97646|NCT02289105|"~     The overall objective of this project is to assess if an active choice intervention can~     increase advance directive completion rates.~   "
97647|NCT02289092|"~     The Positive Family Support Project seeks to understand some of the factors that increase~     success for children in early elementary school, such as positive family support at home.~     This study will inform us on ways to help children learn and succeed in school.~   "
97648|NCT02289079|"~     The purpose of the study is to compare pain control after robotic hysterectomy surgery using~     either liposomal bupivacaine or Bupivacaine when injected during a transversus abdominis~     plane (TAP) block. Robotic hysterectomy is when a patient is electively having robotic~     assisted removal of one's uterus. Both medications liposomal bupivacaine and Bupivacaine are~     standard of care in these types of surgeries.~   "
97649|NCT02289066|"~     This study examines how periodontal disease affects the complications of diabetes and how~     treatment for periodontal disease affects biomarkers associated with the complications of~     diabetes.~   "
97780|NCT02287350|"~     As part of the Pediatric Research Equity Act (PREA) commitment, the objectives of the study~     are to characterize the pharmacokinetic (PK) profile and to determine the safety and~     tolerability of diclofenac potassium oral solution in pediatric subjects experiencing mild to~     moderate acute pain.~   "
97650|NCT02289053|"~     Conflicting guideline recommendations for screening colonoscopy result due to scant data upon~     which to develop appropriate recommendations. No previous study has compared the prevalence~     of advanced adenomas or adenomas (any size) among 40-49 year old individuals with a first~     degree relative (FDR) with colorectal cancer (CRC) versus 40-49 year old average risk~     individuals with no family history of CRC. The purpose of this study is to determine the~     prevalence of colon adenomas in 40-49 year old individuals and identify risk factors~     associated with the presence of advanced adenomas. This data will provide evidence to~     determine appropriate colon cancer screening guidelines in 40-49 year old persons with a~     family history of colon polyps or colorectal cancer.~   "
97651|NCT02289040|"~     Acute kidney injury (AKI) complicates over 50% of cardiac surgical procedures in children~     where it increases morbidity and the use of healthcare resources. The pathogenesis of AKI is~     poorly understood, current diagnostic tests lack specificity and sensitivity, and there is no~     effective treatment. Improving outcomes in patients at risk of AKI has recently been defined~     as a National Health Service priority. The investigators are currently undertaking a program~     of work that is evaluating the role of plasma-derived microvesicles (MV) and MV associated~     microRNAs (miRNA) as diagnostic biomarkers or therapeutic targets in cardiac surgery patients~     at risk of developing AKI. Preliminary results indicate that these biomarkers may have~     clinical utility in adults. An important consideration is whether these biomarkers also have~     utility in children undergoing cardiac surgery. Measurement of MV at serial time points in~     children presents ethical challenges related to conducting clinical research in critically~     ill subjects. It also presents technical challenges related to the very small volumes of~     blood that may be sampled safely from babies and infants undergoing surgery. The aim of the~     study is to provide estimates of the perioperative variance of MV concentrations in 24~     children undergoing cardiac surgery, as well as the frequency of AKI and other adverse~     events, protocol adherence and recruitment rates. This will assist with the design of a~     subsequent prospective observational study that will consider the role of MV/miRNA in~     children undergoing cardiac surgery.~   "
97652|NCT02289027|"~     The objective of this trial is to assess in healthy adults the safety and reactogenicity of a~     new candidate vaccine, cAd3-EBOZ, made of a chimpanzee Adenovirus vector encoding the~     glycoprotein of Zaire Ebola virus. The secondary objectives will be to assess the~     immunogenicity of the candidate vaccine and find the most suitable dose for further~     deployment in epidemic areas in Africa. The 120 planned study subjects will be composed of~     possibly exposed volunteers owning to organisations such as Médecins sans frontières and~     susceptible to be deployed in the outbreak zone (named as possibly exposed volunteers). The~     other volunteers will be adults with no planned travels to the epidemic zone (named as not~     exposed volunteers). The first group will be randomly allocated to two different groups (low~     dose = single injection of 2.5x10e10 viral particles (vp), high dose = single injection of~     5x10e10 vp). The second group will be randomly allocated to three different groups (low dose~     = single injection of 2.5x10e10 viral particles (vp), high dose = single injection of 5x10e10~     vp or placebo = single injection of vaccine diluent). The design will be double-blind.~     Follow-up visits will take place at Day 1, 7, 14, 28, 90 and 180.~   "
97653|NCT02289014|"~     Many cancer patients experience their illness as substantial psychological burden. About half~     of the cancer patients suffer from severe stress symptoms and around one third of the~     patients fulfill the criteria for a clinically relevant psychological disorder (mainly~     anxiety disorder and/or major depression). Studies show, that a high level of distress in~     cancer patients is associated with more side effects of and a reduced compliance for~     oncological treatment.~      Today, the efficacy of psycho-oncological interventions is well studied and proven. Besides~     the reduction of levels of anxiety, distress and depression, psycho-oncological support~     facilitates dealing with physical complaints and increases quality of life. Yet,~     psycho-oncological support is rarely utilized by male patients and insufficiently accessible~     for many patients (i.a. lack of supply in the respective area, cost issues).~      The internet overcomes some of these barriers, as it can be used independently of time and~     location. Internet-based therapies are therefore a growing field of interest in research and~     there is evidence for treatment efficacy for several psychological disorders. Moreover effect~     sizes of traditional face-to-face and interactive web-based interventions are comparable.~     However, web-based interventions for cancer patients are still scarce. The present research~     project therefore develops a comprehensive stress management program accessible for a vast~     number of cancer patients. The study targets primarily to evaluate the feasibility of the~     program (technical, organizational feasibility, accessibility). In addition, the preliminary~     efficacy of the program will be analyzed in order to adapt future programs for specific~     patient groups.~   "
97654|NCT02289001|"~     Based on investigator's hypothesis, that incorporating the SBAR worksheet into the training~     of undergraduate Nursing students will increase their capacity to work in an~     interdisciplinary team, the investigators will assess whether introducing the SBAR improves~     the students' knowledge of their own role and that of others on the team (medical students),~     strengthens communication between team members, and enhances the quality of the patient~     assessment and interventions demonstrated by the nursing students caring for a critical~     patient (represented by a high-fidelity mannequin, a Human Patient Simulator).~   "
97664|NCT02288871|"~     The purpose of this study is to determine why sutureless aortic bioprostheses apparently~     offer better haemodynamic properties compared to sewed-in aortic bioprostheses in patients~     who underwent aortic valve replacement.~      Our approach to address this question is the combination of clinical data with the~     application of specifically validated experimental and computer based analyses to compare the~     performance of these valves under patient-specific conditions.~   "
97683|NCT02288611|"~     This aim of this study is to investigate the prebiotic potential of date fruits in healthy~     human volunteers compared to a control diet. Each arm was 21 days in duration, separated by a~     14 days washout period. Faecal samples, and blood samples will be collected from each~     volunteer and high resolution analytical techniques (HPLC, LC-MS and NMR) will be employed to~     characterise the whole system metabolic response to ingestion of date fruits compared to the~     control. Changes in microbial parameters and metabolite profiles will be correlated with~     changes in biomarkers of chronic disease, including faecal water genotoxicity, cellular~     reactions, blood lipids and bowel movements.~   "
97655|NCT02288988|"~     True short esophagus (TSE) is present when the distance between the esophago-gastric (E-G)~     junction and the apex of the hiatus is shorter than 2.5 cm, without the application of any~     downward pressure on the stomach, after maximal mobilization of the distal thoracic~     esophagus. It has been demonstrated that TSE is present in 20% of patients undergoing routine~     surgery for gastro-esophageal reflux disease (GERD), and in more than 50% of cases of type~     III-IV hiatal hernia (HH) that are treated surgically. Recent reports have confirmed the~     importance of diagnosing and electively treating TSE to reduce the risk of anatomic~     recurrence after surgery. The surgical techniques currently used for the elective treatment~     of TSE are based on the association of the Collis gastroplasty with an anti-reflux~     funduplication and the hiatoplasty, performed using minimally invasive techniques; the~     mortality, morbidity, and outcomes of these procedures remain subjects of debate. In light of~     the doubtful validity of the surgical results for TSE, some researchers have proposed that~     this condition should not be treated with surgical therapy. In the absence of randomized,~     multicenter studies designed to compare the surgical techniques used to treat TSE, the~     investigators believe that data obtained from a single-center study may be useful to the~     surgical community, provided that such data are based on an objective intra-operative~     diagnosis of TSE and a rigorous follow-up period.~   "
97656|NCT02288975|"~     The aim of the study is to investigate the effect of CytoSorb® treatment within the first 48~     hours of septic shock on organ dysfunction, microcirculation and on the cytokine storm as~     monitored by leukocyte activation and inflammatory mediators.~   "
97657|NCT02288962|"~     Due to lack of hormone overproduction in non-functioning pituitary adenomas (NFPAs), only the~     symptomatic adenomas or large adenomas with proven growth and risk for symptoms in near~     future will undergo pituitary surgery. The remaining adenomas are monitored regularly.~     Operation of these large adenomas will rarely remove all tumour tissue, and there is also a~     risk of worsening of pituitary function. Often, adenomas with the highest growth potential~     are operated several times and some also need radiation therapy, providing additional risk~     for pituitary failure. Unlike some of the hormone-producing adenomas, there is no established~     pharmacological treatment for NFPAs. However, there are a few non-randomized studies~     suggesting that treatment with dopamine agonists may slow growth, and also induce tumour~     shrinkage. At present, cabergoline is the dopamine agonist most widely used in the treatment~     of pituitary adenomas secreting prolactin.~      Aim is to study the effect of medical treatment with cabergoline in non-functioning pituitary~     adenomas on the change in tumour volume.~   "
97658|NCT02288949|"~     The American-European Consensus Conference (AECC) and the Berlin definitions of the Acute~     Respiratory Distress Syndrome (ARDS) could be adequate for epidemiologic studies, but it is~     not adequate for inclusion of patients into therapeutic clinical trials. Despite recent~     reports on the effects of standardized ventilator settings on PaO2/FIO2 and fulfillment of~     AECC and Berlin definitions of ARDS, it is still a matter of debate whether the assessment of~     hypoxemia at 24 hours is the most appropriate tool for stratifying lung severity in patients~     with ARDS. The investigators will perform an observational, multicenter, prospective audit in~     a network of intensive care units in Spain and China for validating and confirming that the~     assessment of hypoxemia at 24 hours after ARDS onset is the most valuable tool for~     stratifying and predicting outcome in patients with ARDS.~   "
97659|NCT02288936|"~     Prostate cancer is the most common non-skin tumor diagnosed in men and the second leading~     cause of cancer death in men in Western countries.~      Between 10-20% of patients are diagnosed at metastatic stage and about half of those~     diagnosed in early stages will develop metastases.~      After the clinical benefit of mitoxantrone and the improved survival of 2-3 months provided~     by docetaxel in first line, the second search is driven to look for effective second lines~     treatments. In recent years, there are new drugs for the treatment of prostate cancer,~     revolutionizing the therapeutic sequence and survival.~      Thus, androgen deprivation therapy, treatment of choice, induces an improvement of symptoms~     in approximately 70-80% of patients, but it is limited by the development of mechanisms of~     resistance to androgen deficiency. Docetaxel was the first chemotherapy drug to increase~     survival in patients with metastatic prostate cancer. The second cytotoxic drug approved in~     the second line treatment of metastatic CRPC has been cabazitaxel.~      Enzalutamide improves survival in patients with metastatic CRPC who had progressed to~     chemotherapy and also in patients who had not received chemotherapy.~      To date, there are no biomarkers available that allow us to identify which patients from a~     clinical or molecular view are those that will be able to benefit from the treatment options~     currently available. The presence of the TMPRSS2-ETS rearrangement has been shown to~     correlate with efficacy in clinical practice abiraterone.~      There is scientific and preclinical background that makes one suspect that the molecular~     alteration may influence the same way enzalutamide antiandrogen activity, but it has not been~     determined to date.~      The objective of this study is to determine whether the efficacy and safety of enzalutamide,~     when administered to patients with castration resistant prostate cancer prior to~     administration of docetaxel is influenced by the presence or absence of the fusion gene~     TMPRSS2- ETS.~   "
97660|NCT02288923|"~     Pain after a knee replacement can impair recovery and use of the new knee. Having an~     injection to numb the femoral nerve is known to give good pain relief after the operation but~     may lead to slower mobilisation as it also prevents the patient from moving the knee. Recent~     studies have shown that infiltration of local anaesthetic (LIA) within the new knee joint may~     also give good pain relief. The null hypothesis is that there is no difference in primary or~     secondary outcome measures between femoral nerve block and LIA, as anaesthetic techniques for~     knee replacement.~   "
97661|NCT02288910|"~     This project investigates the feasibility of assessing the relative blood volume of~     carcinomas in patients with Hepatocellular Carcinoma (HCC) and liver metastases from~     pancreatic or colorectal cancer compared to normal liver from DynaCT acquisitions on an~     interventional platform.~   "
97662|NCT02288897|"~     This is an international multicenter, open-label, randomized controlled trial (RCT) of~     single-agent intralesional PV-10 versus systemic chemotherapy or intralesional oncolytic~     viral therapy to assess treatment of locally advanced cutaneous melanoma in patients who (1)~     are not candidates for targeted therapy and (2) are not candidates for an immune checkpoint~     inhibitor. Subjects in the comparator arm will receive the Investigator's choice of~     dacarbazine (DTIC), temozolomide (TMZ) or intralesional talimogene laherparepvec as~     determined by Investigator preference and standard of care in the Investigator's country or~     region. Effectiveness will be assessed by comparison of progression-free survival (PFS)~     between all intent-to-treat (ITT) subjects in the two study treatment arms.~   "
97663|NCT02288884|"~     The purpose of this study is to determine the effect of a silver containing dressing~     (Acticoat Post-Op) compared to a standard dressing (OpSite PostOp) on post elective cesarean~     section wound complications in obese women (BMI >35).~   "
97781|NCT02287337|"~     The purpose of this study is to see if a recently developed clinical prediction rule (CPR)~     will successfully identify which patients with neck pain will respond rapidly and favorably~     to manipulation of their cervical spine.~   "
97665|NCT02288858|"~     The purpose of this multi-site, double-blind, placebo-controlled clinical study, conducted~     for Lifes2Good, is to evaluate certain physiological effects of Viviscal Oral Supplement~     compared to a placebo in female subjects with self-perceived thinning hair associated with~     poor diet, stress, hormonal influences, or abnormal menstrual cycles.~      Viviscal is an oral food supplement specifically designed to promote the quality of existing~     hair growth and/or to promote new hair re-growth for women suffering from temporary thinning~     hair. It does not contain hormones, drugs, or industry by-products. Viviscal has been~     marketed in Europe for over 15 years. The key ingredient is AminoMar C - a protein rich~     compound of marine extracts blended with soluble silica and fortified with Vitamin C.~     Viviscal provides essential nutrients to nourish hair naturally from within. Viviscal works~     over several months of use to improve the appearance of thinning hair.~   "
97666|NCT02288845|"~     The purpose of this study is to determine the relationship between ITI-007 dose, plasma~     levels and brain receptor occupancy in patients with stable schizophrenia.~   "
97667|NCT02288832|"~     Infection is the principal cause of preterm births. Most (90%) women with preterm deliveries~     have no abnormal history. It is widely agreed that preterm delivery is often associated with~     bacterial vaginosis. One of the major difficulties at this time is that the diagnosis of~     bacterial vaginosis is based on heterogeneous criteria. The technique currently used is the~     Nugent score, but it lacks the characteristics necessary for widespread use in the general~     population. It must be performed on a fresh swab, and any delay in transporting it can cause~     drying that makes the test difficult to perform.~      The investigators have developed a rapid diagnostic tool for bacterial vaginosis using~     molecular biology based on a point of care model and obtained a patent (European Patent~     Office N° 2087134). In comparison with the reference techniques, our tool's performance has~     been excellent, in terms of specificity, sensitivity, and positive and negative predictive~     values. In particular, our work showed that 57% of the flora samples rated as intermediate on~     the Nugent score were in reality true bacterial vaginosis. Molecular biology therefore~     identifies a homogeneous population of women with vaginal flora anomalies. The investigators~     recently showed that the carriage of Atopobium vaginae and/or Gardnerella vaginalis >105/mL~     shortens the time to delivery in a population at risk of preterm delivery (PHRC 2006).~     Vaginal flora anomalies are therefore an important target for preventing preterm delivery.~   "
97668|NCT02288819|"~     The primary objective of this study is to assess whether the urinary sodium/creatinine or~     chloride/creatinine ratio might predict successful downtitration of loop diuretics in~     patients with stable heart failure without clinical signs of volume overload. In addition,~     this study will provide information on loop diuretic efficiency and urinary electrolyte~     composition after intake of diuretics in stable outpatients with heart failure.~   "
97669|NCT02288793|"~     The study evaluates the knowledge and attitude about Focused Assessment with Sonography in~     Trauma examination among medical students and medical staff in Poland.~   "
97670|NCT02288780|"~     Transurethral resection of the prostate (TURP) is a standard surgical treatment for benign~     prostatic hyperplasia (BPH). Non-conductive irrigation fluid is used to maintain good~     visibility of the operating field during resection of the prostate. Absorption of this~     hypotonic solution into the bloodstream can cause fluid overload and dilutional hyponatremia,~     resulting in adverse cardiovascular and central nervous system effects, transurethral~     resection (TUR) syndrome. BPH is common in elderly men above 60 years old. These aged people~     commonly have diastolic impairment by normal physiologic change without consistent symptom.~     This study aimed to evaluate the cardiac function focused mainly diastolic function during~     TURP with transthoracic echocardiography. Also, we will focus the effets of amount of~     irrgation fluid on left ventricular diastolic function in patients with pre-existing~     diastolic dysfunction.~   "
97671|NCT02288767|"~     During an enterectomy, especially in an open surgery, large amounts of fluid are administered~     in consideration of the patient's fasted state, maintaining blood pressure during surgery and~     potential third space loss. However, it has recently been reported that excessive fluid~     administration during surgery is actually detrimental to patients' prognoses. In fact,~     several reports have suggested that compared to limited fluid administration, excessive fluid~     administration increased the length of stay or the chances of complications. Thus,~     goal-directed fluid optimization is required during surgery because only a proper amount of~     fluid (neither limited nor excessive) administration can minimize postoperative complications~     and enhance prognosis. In general, the amount of fluid administered is determined with regard~     to the patient's volume status, including a comprehensive assessment of vital signs such as~     the pulse rate and blood pressure, and urine volume. However, this method has limitations in~     that it is an inadequate indicator of the actual intravascular volume of a patient to~     determine and administer the proper amount of fluid. Recently, new methods of measuring~     volume status that are less invasive and more accurate have been introduced. These methods~     include stroke volume variation (SVV) that monitors changes in arterial pressure waveform~     amplitudes with regard to breathing patterns. This is an effective method of monitoring fluid~     responsiveness after placing a catheter via a radial artery puncture. The stroke output is~     dependent on the preload, afterload, and cardiac contractility. The cardiac output is~     determined by multiplying the stroke output and heart rate. SVV indicates the difference in~     stroke output within one breathing cycle. A direct or indirect measurement of stroke output~     is required, which can be performed by analyzing arterial pressure waveforms via a FloTrac~     Sensor (Edwards Lifesciences, USA) monitor. SVV is known to have a high fluid responsiveness~     even during open surgeries, yet there is practically no research data on its effect in~     patients' postoperative recovery and prognosis in comparison to the traditional methods of~     fluid administration. Therefore, the investigators will apply SVV via a FloTrac/ Vigileo™~     monitor on patients undergoing bowel resection to determine whether it better assists proper~     fluid administration compared to the traditional method of fluid administration by examining~     the patients' postoperative prognosis such as bowel movement recovery and length of stay.~   "
97672|NCT02288754|"~     The aim of this study is to employ genomic detection methodologies to measure the relative~     amount of tumor nucleic acids in the blood of a cancer patient with diagnosed metastatic~     disease that is either commencing, currently undergoing or completed cytotoxic chemotherapy~     treatment. More generally, this approach will allow us to develop a quantitative measure of~     therapy efficacy via the counting of the relative changes in tumor molecules over the course~     of treatment.~   "
97673|NCT02288741|"~     Patients 60 to 70 years of age with newly diagnosed multiple myeloma were prospectively~     randomized between 4 cycles of anthracycline/dexamethasone-based induction chemotherapy (A1)~     or only 2 x 4 days of dexamethasone (A2). A reference arm included patients who could not be~     randomized (B). Tandem melphalan 140 mg/m² (MEL140) with autologous transplantation was~     scheduled for all patients.~   "
97684|NCT02288598|"~     This study aims to test whether the addition of transcranial direct current stimulation~     (TDCS) to speech fluency training results in improvements in speech fluency in adults with~     developmental stuttering. Half of the participants will receive anodal TDCS on five~     consecutive days, the other half will receive a sham stimulation for the same amount of time.~   "
97782|NCT02287324|"~     The purpose of the study is to see if manipulation of the neck will change the way people who~     may or may not have neck pain, walk under differing conditions.~   "
97674|NCT02288728|"~     Gastric cancer as one of the most common gastrointestinal cancers, radical resection of~     primary lesions combined with dissection of regional lymph-nodes is acknowledged by surgeons~     all over the world. When compared with the advanced upper third gastric cancer, proximal~     gastrectomy has been acknowledged as the standard therapeutic strategy for the early gastric~     cancer located in the upper third of the stomach. However, due to abandon the anti-reflux~     barrier of the digestive system caused by the dissection of the cardia and the lower~     esophageal sphincter, the belching、hiccup、Acid reflux、heartburn、chest pain symptoms and as~     well as the reflux esophagitis caused by the traditional esophagostomy permanently influence~     the postoperative quality of life for those patients. Nowadays, relationship between the~     digestive track reconstruction for proximal gastrectomy and the postoperative quality of life~     is still with controversies. Previous study reported the gastric tube anastomosis can~     minimize the reflux related symptoms when compared with traditional esophagogastrostomy.~     There still exited some patients need long-term anti-acid drug to control the reflux symptoms~     although underwent the gastric tube anastomosis. The double-track anastomosis for proximal~     gastrectomy may successfully control the reflux symptoms and there existed study found it is~     as safe as the esophagostomy. But there has no randomized control study to compare the~     postoperative quality of life between the gastric tube anastomosis and double-track~     anastomosis for proximal gastrectomy.~      By the reasons above, a randomized controlled trial is conducted with the intention to~     compare the intraoperative and postoperative mortality and morbidity and the postoperative~     quality of life between the esophagogastrostomy and the double-track anastomosis in the~     proximal gastrectomy for gastric cancer patients.~   "
97675|NCT02288715|"~     The purpose of the study is to evaluate whether variability of CPP (cerebral perfusion~     pressure) is related to sepsis-associated encephalopathy and outcomes of patients with~     sepsis.~   "
97676|NCT02288702|"~     About 1 in every 700 babies born in the United States has Down's Syndrome (DS; Trisomy 21),~     99% of whom have some degree of intellectual disability. Recent advances in medicine have~     resulted in a dramatically improved lifespan of about 25 to 60 years of age. Yet, there is~     limited data about anesthetic management in this increasing patient population. The~     bispectral index (BIS) monitor is a non-invasive monitoring device that reports a value~     between 0 and 100correlating to level of consciousness of an individual. A value of 0~     indicates lack of brain activity while 100 indicates an awake/alert state. This monitor can~     be used to assess the depth of anesthesia. Patients with intellectual disability from~     congenital neurological diseases have lower BIS values compared to patients without any~     neurological impairment (Valkenburg 2009). The results may suggest that DS patients would~     require less anesthetic drugs compared to patients without any neurological impairment. To~     date, there are no studies in DS patients.~   "
97677|NCT02288689|"~     In this study the investigators aim to compare the cervical dilation time in pregnant~     patients at term who had clinical evaluation of the cervical consistency with patients who~     had also quantitative measurement of the cervical elasticity in .~   "
97678|NCT02288676|"~     This study will determine whether a genetic test of Pap samples detects ovarian and~     endometrial cancers.~   "
97679|NCT02288663|"~     Glomerular filtration rate (GFR) is the recommended parameter to assess renal function. The~     reference technique to measure GFR (clearance of a glomerular agent) is not commonly used.~     Instead, estimations (eGFR) are routinely taken from serum creatinine (SCr) with several~     published formulae: Cockcroft and Gault, MDRD, CKD-EPI. Basically, all these formulae aim at~     predicting the endogenous creatinine production by morphological parameters (age, body~     weight...) However, in the elderly, muscular mass is extremely variable and sarcopenia is~     quite commonly encountered (frequently linked to Alzheimer disease). This is probably the~     main reason why the aforementioned formulae are not valid in this population: for a given~     renal function, a lower muscular mass induces a lower creatinine production and, henceforth,~     a lower SCr value, which gives an overestimation of eGFR.~      Muscular mass is closely linked to lean body mass (LBM), which can be properly assessed by~     whole-body dual X-ray absorptiometry (DXA). Alternatively, Bioelectric Impedance Spectroscopy~     (BIS) can also be used.~      Investigators postulate that it is possible to estimate GFR in the elderly from both SCr and~     LBM estimation from DXA. Proof of concept has already been made by others but until now, no~     specific formula for the elderly has been devised and properly validated.~      Investigators'aim is thus to propose a new formula to predict GFR from both SCr and LBM~     (estimated from DXA) in the elderly. This formula will be elaborated from a first series of~     100 patients and validated on a second series of 100 other patients.~   "
97680|NCT02288650|"~     At the child, the post-operative vomitings (POV) remain the main post-operative complication~     in term of frequency. They also represent the first cause of unforeseen hospitalization in~     day case surgery. The causes of POV are multiple, including in particular the post-operative~     prescription of opioids. The role of the premature refeeding remains discussed.~      Up to the age of 4 years, acute pain is difficult to distinguish from other causes of~     distress (anxiety, anger but also hunger) being able to make prescribe wrongly opioids in~     post-operative.~      The main objective of this study is to estimate the POV in pediatric day case surgery after~     early refeeding with clear liquids in the recovery room or only in the day case wards (usual~     practice).~      The secondary objectives are to estimate the time on returning to the day case ward, at home,~     the post-operative opioid consumption, early refeeding adverse effects (desaturation,~     swallowing trouble)~   "
97681|NCT02288637|"~     The proposed study is a four-arm randomized control trial (RCT) in 48 villages in the Lakes~     region in Tanzania comparing the relative effectiveness of 4 vector control interventions for~     reducing malaria transmission and controlling vector populations in an area where An gambiae~     s.s is pyrethroid and carbamate resistant: 1/ a standard long lasting insecticidal net~     (LLIN), 2/ a LLIN which incorporates a piperonyl butoxide (PBO) synergist, 3/ a long lasting~     indoor residual spray (IRS) formulation used in conjunction with standard pyrethroid LLIN or~     4/ the long lasting indoor residual spray (IRS) formulation used in conjunction with the LLIN~     which incorporates a PBO synergist.~      The trial will provide epidemiological, entomological, economic and social evidence of~     impact, as the investigators shall be measuring the reductions in malaria prevalence and~     malaria transmission rates EIR, and changes in the frequency of resistance, mosquito species~     ratios and economic cost effectiveness. The proposed trial will demonstrate whether the novel~     LLIN and long lasting IRS formulation will be more effective for controlling An.gambiae s.s.~     and reducing malaria prevalence than current practice with the conventional LLIN. There is~     great interest in conducting this trial. Alternative vector control products are limited and~     most new insecticides are not suitable for use on LLINs or as IRS.~   "
97682|NCT02288624|"~     This is a human dietary intervention study that is randomized and crossover in design with 4~     treatment arms consisting of control, orange juice,whole orange, and processed whole orange~     to investigate the satiety effects of the treatments in healthy volunteers. Self reported~     hunger and fullness scores by Visual Analogue Scale (VAS) form were collected at different~     time points prior to and post consumption of each treatment.~   "
97686|NCT02288572|"~     The metabolic syndrome is increasing worldwide, including developing countries. The metabolic~     syndrome is composed of clinical expressed symptoms as central obesity, high blood pressure,~     raised fasting plasma glucose or diagnosed diabetes, low HDL, and raised serum triglycerides.~     All those components together or independently contribute to the development of~     cardiovascular diseases, which are the leading cause of death in the modern world. The~     results from previous studies have shown that probiotic bacteria have an influence on health~     improvement, and can exert positive effects on diseases as diabetes, high blood pressure,~     dyslipidemia and low-grade inflammation, which are all components of the metabolic syndrome.~     The objectives of this study were to investigate which of probiotic strains Lactobacillus~     plantarum PCS 20, Lactobacillus plantarum PCS 26 in Lactobacillus rhamnosus GG exert positive~     effects in the cascade of molecular reactions at the level of small intestines, at remodeling~     of monocytes/macrophages and adipocytes in human cell model of non-cancerous origin, and to~     provide scientific explanation of mechanisms of possible multi-leveled activity of selected~     probiotic strains in patients with metabolic syndrome. For this purpose, the investigators~     divided this research into two parts. The first part consisted of pre-clinical in-vitro~     laboratory study. It examined the mechanisms of actions of probiotic cultures with the use of~     functional cell models of non-cancerous origin, more specifically, with the use of cell lines~     of human intestinal epithelium, human monocytes/macrophages and human visceral preadipocytes.~     In in-vitro laboratory study, the investigators demonstrated that probiotic strain~     Lactobacillus plantarum PCS 26 exerts positive effects, which could help to relieve the~     particular components of the syndrome in the host with metabolic syndrome. The second part of~     the research consisted of prospective, double-blind and placebo-controlled in-vivo pilot~     clinical study, which included 16 volunteers with the metabolic syndrome. Results have shown~     that probiotic strain Lactobacillus plantarum PCS 26 exerts positive effects on reduction of~     waist circumference, on lowering of serum cholesterol concentration, and on maintenance of~     serum adiponectin levels. Those effects together can contribute to the alleviation of the~     metabolic syndrome, especially in terms of clinical manifestation and risks in relation to~     cardiovascular diseases.~   "
97687|NCT02288559|"~     This multicenter, randomized, single-masked, sham injection-controlled study will investigate~     the exposure-response and safety of lampalizumab administered intravitreally every 2 weeks~     (Q2W) or every 4 weeks (Q4W) for 24 weeks in participants with geographic atrophy (GA)~     secondary to age-related macular degeneration (AMD). A safety run-in assessment will be~     conducted prior to initiating enrollment in the randomized study.~   "
97688|NCT02288546|"~     This research concerns nutritional and toxicological health risk evaluation among long-term~     vegans. Research focus is in cumulative exposure to pesticides.~   "
97689|NCT02288533|"~     Chronic consciousness disorders have high level of impact on public health and its costs.~   "
97690|NCT02288520|"~     This is a longitudinal, observational, prospective, multicentre study conducted in~     metropolitan France, among a representative sample of office-based or mixed practice~     rheumatology doctors.~      The aim of this study is to describe in real life, the therapy strategy when faced with a~     patient treated with methotrexate as a monotherapy consulting for rheumatoid arthritis and~     the impact on the progression of the disease at 6 months.~   "
97691|NCT02288507|"~     This study evaluates the safety and efficacy of administering sorafenib concurrent with~     yttrium-90 radioembolization to patients with advanced hepatocellular cancer.~   "
97692|NCT02288494|"~     The primary purpose was to describe the acid base balance of ICU patients with severe~     hypoalbuminemia using Stewart's approach for acid base disorders, before and after an human~     albumin perfusion.~   "
97693|NCT02288481|"~     The objective of this study is to evaluate the safety and tolerability of single oral doses~     of TBA‐354 when administered to healthy adult subjects.~   "
97694|NCT02288468|"~     Randomised, active controlled, double blinded (patient and observer blinded), monocentric~     trial with three treatments, three periods and six treatment sequences allocated according to~     a Williams design~   "
97695|NCT02288455|"~     The purpose of this investigation is to demonstrate the safety and efficacy of the GTU~     artificial urinary sphincter device in restoring continence in males who have confirmed~     urinary stress incontinence for a minimum of 12 months with primary etiology being radical~     prostatectomy or transurethral resection of the prostate (TURP).~   "
97696|NCT02288442|"~     The purpose of this RCT is to study the effects of whole muscle training (inspiratory muscle~     training + aerobic training + muscle resistance training) on muscle power, VO2peak and~     gas-exchange variables obtained during cardiopulmonary exercise testing, QoL, functional~     capacity (eg, 6-min walking distance), and maximal inspiratory pressure in patients with~     pulmonary artery hypertension.~   "
97697|NCT02288429|"~     Colistin is a polymixin antibiotic used in the treatment of multidrug-resistant gram-negative~     infections. Given the limited use of colistin and previous challenges with laboratory assays~     to determine plasma concentrations, there is a lack of knowledge of the pharmacokinetic~     profile of colistin. The purpose of the investigators observational prospective~     pharmacokinetic cohort study is to examine the steady-state pharmacokinetic and~     pharmacodynamic properties of intravenous colistimethate sodium in cystic fibrosis and~     critically ill patients.~   "
97698|NCT02288416|"~     This pilot trial studies a video-based intervention in reducing anxiety in patients~     undergoing lung cancer screening. Giving a video-based intervention to patients prior to lung~     cancer screening may reduce anxiety and improve the well-being and quality of life.~   "
97699|NCT02288403|"~     Aerobic exercise produces increases in cardiorespiratory fitness (CF), which constitute a~     protective factor for cardiovascular disease and all-cause mortality. Therefore, aerobic~     exercise is a key strategy to promoting cardiovascular. There is some evidence that aerobic~     high intensity interval training may lead to greater increases in CF compared with continuous~     moderate-intensity training.~      The main objective of this study is to examine the effects of an aerobic high intensity~     training program versus a continuous moderate intensity training program on CF in men 18 to~     44 years.~   "
97700|NCT02288390|"~     Dental plaque score calculation and swabs of Oropharynx and teeth were collected on~     admission. For group I, Miswak stick was used 4 hourly for oral care. For group II, 0.12%~     Chlorhexidine/ toothbrush were used 4 hourly~   "
97701|NCT02288377|"~     This European, prospective, multicentre, double-blind randomised study will evaluate the~     effect of lanreotide (120 mg every 28 days until disease progression) versus placebo in~     patients with metastatic/locally advanced, non-resectable, duodeno-pancreatic neuroendocrine~     tumours.~   "
97796|NCT02287142|"~     The aim of this study is to assess analgesic efficacy of a supraclavicular nerve block,~     suprascapular nerve block, or interscalene nerve block in a population undergoing shoulder~     arthroscopy with rotator cuff repair. The investigators hypothesize that subjects from all~     three arms will receive equal analgesia since these blocks are routinely performed to treat~     post-operative pain after shoulder surgery.~   "
98387|NCT02279407|"~     This study is a double-blind randomized, placebo-controlled, parallel-group, 12 week study~     performed in up to 5 centres in Sweden to assess the effect of Omega-3 carboxylic acids and~     dapagliflozin on liver fat in patients with Type 2 diabetes with fatty liver (>5.5% as~     measured with magnetic resonance imaging (MRI))~   "
97702|NCT02288364|"~     The purpose of this study is to determine the benefit, if any, of buffering lidocaine (adding~     sodium bicarbonate) when used for local anesthesia prior to percutaneous breast needle core~     biopsies. The medicine doctors use to reduce the pain of breast biopsies, lidocaine, can~     cause pain for approximately 15 seconds until the numbing effect begins. It is possible that~     this pain is caused because lidocaine is acidic. Some physicians believe that reducing the~     acidity of lidocaine by mixing it with sodium bicarbonate will reduce the initial pain of~     injecting the lidocaine. Both approaches - injecting 1% lidocaine alone and injecting 1%~     lidocaine mixed with sodium bicarbonate - are used as routine standard of care by~     radiologists today. The purpose of this study is to determine if either approach is more~     comfortable for patients having breast procedures.~   "
97703|NCT02288351|"~     The purpose of this study is to investigate small intestinal remodeling and reprogramming of~     glucose metabolism in patients with Type 2 Diabetes Mellitus (T2DM) who undergo laparoscopic~     Roux-en-Y Gastric Bypass (RYGB). Our specific goal is to determine if the gene and protein~     expression levels of GLUT-1 are up regulated in the Roux limb and whether this is a major~     mechanism for the remission of T2DM following RYGB.~      The two aims of the study are: 1) to demonstrate that the basement membrane glucose~     transporter 1 (GLUT-1) is upregulated in the Roux limb following RYGB, and 2) to demonstrate~     that the upregulation of GLUT-1 is a major mechanism for the improvement in glycemic control~     observed in T2DM patients undergoing RYGB.~   "
97704|NCT02288338|"~     A randomized open-label, multiple dose, three-treatment, three-period, six-sequence,~     crossover study to investigate the pharmacokinetic drug interaction between Atorvastatin and~     Ezetimibe after oral administration in healthy volunteers~   "
97705|NCT02288325|"~     This study evaluates the efficacy, safety and tolerability of levomilnacipran~     extended-release (ER) compared with placebo in the prevention of depression relapse (MDD).~   "
97706|NCT02288312|"~     Single-centre, open-label, randomised, gender-balanced, 3-way crossover, 3-period, 3-sequence~     study in 18 healthy male and female subjects.~   "
97707|NCT02288299|"~     The long-term effect of LIAM (Lung Insufflation Assist Maneuver) on respiratory performance~     in home non-invasively ventilated (NIV) patients suffering from neuromuscular disease will be~     assessed in a prospective, randomized, cross over, open label study~   "
97708|NCT02288286|"~     The purpose of this study is to evaluate the safety and immunogenicity of freeze-dried rabies~     vaccine (MRC-5 cells)in different age health human populations, according to the traditional~     Essen methods (1-1-1-1-1) vaccination.~   "
97709|NCT02288273|"~     A Randomized, Double-blind, Parallel-group Study to Evaluate the Effect of Bydureon Compared~     with Placebo on 24-hour Glucose Control in Metformin-treated Patients with Type 2 Diabetes.~   "
97710|NCT02288260|"~     This NIS is a multi-centre, observational, descriptive, cross-sectional study including all~     consecutive patients with Acute Coronary Syndrome (ACS) and a single-arm, prospective,~     longitudinal cohort study which will include patients hospitalized for ACS and who are with~     ticagrelor on discharge from hospital.~   "
97711|NCT02288247|"~     The purpose of the study is to understand if there is benefit in continued treatment with a~     medicine called enzalutamide, when starting treatment with docetaxel and prednisolone (a~     standard chemotherapy for prostate cancer), after the prostate cancer has gotten worse when~     treated with enzalutamide alone.~   "
97712|NCT02288234|"~     The telavancin observational use registry (TOUR) will collect data to support study of the~     efficacy, safety, and pattern of use of telavancin in hospital-based inpatients and in~     outpatients being treated in infusion centers who are receiving clinician directed telavancin~     therapy.~   "
97713|NCT02288221|"~     All over the world the increasing prevalence of chronic disorders and its impact on~     functional decline is challenging the sustainability of health care systems. Older~     individuals also frequently experience the reversible frailty syndrome, which overlaps with~     chronic diseases, increasing incidence of disability.~      Building a global system aiming to take in charge all causes leading to loss of autonomy is a~     rather complicated task involving numerous Information and Communication technologies (ICT)~     solutions which are not always easy to use in everyday life.~      The SafEE (Safe Easy Environment) project aim is to improve the safety, autonomy and quality~     of life of older people at risk.~      The SafEE project develop non pharmacological therapeutic through diferent ICT (stimulation~     aromatherapy automatic fragrance, training interface based on Kinect sensor...) .~      The goal of this study is to validate the acceptability, sensitivity and efficacy of the~     systems.~   "
97714|NCT02288208|"~     This study evaluates the addition of birinapant in subjects with chronic Hepatitis B who are~     currently receiving anti-viral therapy with either tenofovir or entecavir. Patients will~     receive either birinapant or placebo in addition to their anti-viral therapy.~   "
97715|NCT02288195|"~     Although neoadjuvant radiotherapy greatly decreases local recurrence in locally advanced~     rectal cancer patients undergoing surgery, it inevitably results in short-term and long-term~     toxicities. More importantly, it has not been confirmed that neoadjuvant radiotherapy could~     improve overall survival. The purpose of this study is to compare the effects of chemotherapy~     alone using a combination regimen known as XELOX (capecitabine and oxaliplatin ) and~     selective use of the standard treatment to the standard treatment of chemotherapy and~     radiation.~   "
97716|NCT02288182|"~     A randomized controlled clinical trial to investigate the capability of Straumann® VivOss™~     compared to Geistlich Bio-Oss in sinus floor augmentation to demonstrate superiority of~     Straumann® VivOss™ compared to Geistlich Bio-Oss in regards to the ratio of newly formed bone~     to residual bone substitute.~   "
97766|NCT02287532|"~     The aim of the TELESAGE study is to demonstrate~        1. the superiority of follow up with the DIABEO system (software alone) versus usual follow~          up in terms of improvement in HbA1c after 1 year in DM1 or DM2 patients treated with a~          basal-bolus insulin regimen.~        2. the superiority of follow up with the DIABEO system (software + telemonitoring) compared~          to usual follow up in terms of improvement in HbA1c after 1 year in DM1 or DM2 patients~          treated with a basal-bolus insulin regimen.~      The DIABEO software alone is an electronic diary system incorporating an immediate automatic~     aid to calculating the insulin dose according to the prescription given by the doctor, and a~     data processing, automated analysis message and secure internet data transfer system.~      The DIABEO software added by paramedical telemonitoring is the electronic diary combined with~     remote paramedical monitoring of data (telemeonitoring)~   "
97717|NCT02288169|"~     Regardless of their treatment, cancer patients endure a variety of difficult symptoms during~     their disease with averages ranging from 7 to 14 symptoms each. Cancer-related symptoms,~     especially when symptoms are very intense, distressing, frequent, or interfere with daily~     activities, can lead to depression, anxiety, and diminished quality of life. Improving their~     ability to self-manage difficult symptoms has the potential to diminish suffering, improve~     quality of life and decrease emergency room visits and associated costs. The investigators~     propose to test a brief, effective intervention with outpatients in a cancer center, with the~     goal of teaching patients symptom management skills for self-identified symptoms of highest~     priority to patients. Objective: The proposed randomized clinical trial will test the~     efficacy of the COPE intervention with patients with symptoms of moderate to high intensity,~     distress, frequency or interference with their lives as a result of their cancer. Method: The~     investigators will seek 300 completed subjects, outpatients with breast, colorectal, lung,~     and prostate cancers. Patients will be randomized into three groups. Group III, the~     experimental group, will receive usual care plus the COPE intervention. This group will~     receive 3 individual intervention sessions. During the first intervention visit at the cancer~     center, the COPE group will be taught the COPE intervention in a session focusing on the~     patient's self-identified most bothersome symptom. Role modeling and additional instruction~     will be provided via video, and patients will receive the Home Care Guide for Cancer and a~     copy of the video to take home. Three subsequent visits with the patient during regularly~     scheduled clinic visits will reinforce the principles of COPE and the use of the Home Care~     Guide, and will help patients apply this approach to managing other symptoms. In addition~     they will get 2 phone calls encouraging them to apply COPE. Group II, the attention control~     group, will receive supportive visits from the research team at the cancer center and~     subsequent meetings during clinic visits plus 2 subsequent supportive telephone calls,~     matched for time with COPE participants. Group I, the control group receiving usual care,~     will receive no additional attention from our interventionists. Data will be collected weekly~     for 9 weeks about symptoms (intensity, frequency, interference, appraisal of distress),~     self-efficacy, and barriers to self-management. Patient Outcomes: Quality of life, anxiety~     and depression will be assessed at baseline and weeks 4, 8, and 12. The investigators predict~     that the COPE group will show significant improvement in depression, anxiety, quality of~     life, symptom intensity, distress, frequency and interference, self-efficacy, and perceived~     barriers to care, as well as decreased utilization of health care resources compared with the~     two control groups. Data will be analyzed using repeated measures multivariate analysis of~     variance using a mixed model approach.~   "
97718|NCT02288156|"~     Chronic rhinitis is affecting more than 200 million people worldwide. Its prevalence is~     estimated to be as high as 30% of the Western population. Rhinitis is defined as symptomatic~     inflammation of the inner lining of the nose and is characterized by the following symptoms:~     rhinorrhea, nasal blockage, nasal itching and/or sneezing. The cut-off point for defining~     rhinitis as chronic rhinitis is considered to be persisting symptoms for over more than~     twelve weeks Chronic rhinitis can be divided into three major subgroups; based on the~     knowledge of the major etiological factor: infectious rhinitis, allergic rhinitis and~     non-allergic, non-infectious rhinitis, in literature also referred to as nonallergic~     rhinitis. Non-inferiority in efficacy of the two novel treatment regimes i.e. capsaicin nasal~     spray 0,01mM (2puffs/nostril/day) during 4 weeks and capsaicin nasal spray 0,001mM~     (2puffs/nostril/day) during 4 weeks compared to the current treatment of capsaicin nasal~     spray 0,1mM (5/day administered on a single day) with regard to the change from baseline in~     VAS for major nasal symptom on week 4.~      (Estimated placebo effect is 25%.)~   "
97719|NCT02288143|"~     This is a pilot study evaluating the effect of a simplified low-cost (friendly) controlled~     ovarian stimulation using clomiphene citrate, letrozole, and low-dose hMG on the number of~     oocytes retrieved.~   "
97720|NCT02288130|"~     Rationale: Laparoscopic myomectomy is increasingly performed over laparotomic myomectomy,~     because of the many benefits for the patient in terms of pain, hospital stay and recovery. In~     order to increase the success rate of a laparoscopic procedure pre-treatment to decrease the~     volume might be beneficial. Gonadotropin-releasing hormone agonists (GnRHa) are used for this~     purpose with good results in terms of volume reduction, but sometimes resulting in loss of~     distinction of the right surgical planes. Ulipristal is a new pre-operative treatment option~     for symptomatic fibroids, which has demonstrated good results in terms of volume reduction.~     The effect on cleavage planes is unknown. This study is performed to evaluate if Ulipristal~     is as effective as GnRHa in terms of surgical outcome.~      Objective: to investigate if Ulipristal is non-inferior to GnRH in terms of intra-operative~     blood-loss (primary outcome), surgical time, surgical ease, complications, quality of life~     and costs.~      Study design: Double blind randomized controlled multi-center trial. Study population:~     Premenopausal women in whom a maximum of 2 symptomatic intramural fibroids between 5 and 12~     cm in diameter will be removed. Fibroid types 3, 4, 5, 6 and 2-5 will be included.~      Intervention: Three months of Ulipristal 5 mg once daily combined with a single saline~     injection at the onset of pretreatment (produced as placebo of Leuproreline) or (comparison)~     11.25 mg Leuproreline injections at the onset of pretreatment with placebo tablets (once~     daily) .~      Methods: Within 1 month after pre-treatment patients will undergo a laparoscopic myomectomy~     by experienced surgeons. Operative characteristics will be recorded prospectively. Follow up~     will be 6 months after surgery mainly for quality of life assessment. A cost utility analysis~     will be conducted alongside the trial.~      Main study parameters/endpoints: Ulipristal is non-inferior to GnRHa in terms of blood loss~     during surgery when the average difference between the two groups is below 150 ml (standard~     deviation 250 ml).~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: Both Ulipristal and GnRHa have been registered for this indication. Safety has~     been tested and no specific risks apply.~   "
97721|NCT02288117|"~     The objective of this PMCF is to collect clinical and radiographic outcome information on~     Total Hip Arthroplasty (THA) performed with LINK® SP-CL® Hip Prosthesis Stem under routine~     conditions.~      The results collected will be used to clinically confirm the performance and safety of the~     LINK® SP-CL® Hip Prosthesis Stem in terms of the manufacturer's obligation to perform a PMCF.~     Furthermore the results can be used for future regulatory processes if needed.~   "
97722|NCT02288104|"~     This study is a prospective study in order to demonstrate the technical feasibility and~     safety of doing endomicroscopic imaging during interventional radiology procedure in two main~     indications: Kidneys and liver.~      This innovative study will involve the use of probe-based confocal laser endomicroscopy. The~     proposed study is a feasibility study.~   "
97723|NCT02288091|"~     This is a single center, open label, 12-week study of inosine treatment. Inosine treatment~     leads to an increase in the levels of urate (uric acid) in the blood.~      The primary objective of the study is to determine the tolerability of oral administration of~     inosine.~      Secondary study objectives include the measurement of biomarkers of oxidative stress and~     damage in response to inosine treatment.~   "
97724|NCT02288078|"~     The objective of this randomized placebo-controlled Phase 2 study is to evaluate prophylactic~     effects of dexamethasone for fatigue and malaise (weakness, lethargy, malaise) resulting from~     regorafenib treatment, as well as to assess treatment continuation of regorafenib.~   "
97725|NCT02288065|"~     Retrospective survey for factors predicting the outcome of medical thoracoscopy~   "
97767|NCT02287519|"~     This research study is evaluating an educational intervention for women who have experienced~     changes in sexual function after treatment for ovarian cancer.~   "
97797|NCT02287129|"~     Metabolic and Molecular Response evaluation for the individualization of therapy in~     adenocarcinomas of the gastroesophageal junction by evaluation of the R0 resection rate for~     patients with metabolically (ie, according to PET criteria) chemotherapy-resistant locally~     advanced AEG, who receive an intensified neoadjuvant chemoradiotherapy (INRCT). Additonal~     efforts will be done by investigation of molecular and metabolic biomarkers in relation to~     their predictive and prognostic value by correlating them with histopathologic responses and~     clinical outcome in an exploratory approach.~   "
97726|NCT02288052|"~     The basal ganglia play an important role in motor learning, especially during the~     consolidation phase of motor learning. This raises the question whether it is possible to~     sustain learning increments in a neurodegenerative condition such as Parkinson's disease~     (PD). The aim of this study is to gain knowledge on whether it is possible to relearn skills~     which are actually affected by PD, such as writing, and determine whether neuroplasticity is~     possible. In this randomized controlled study, PD patients will either follow intensive~     writing training or a placebo treatment (stretch and relaxation training) during 6 weeks. The~     writing training will focus on automatization (withstanding dual task interference), transfer~     to an untrained task and retention. The placebo program is aimed to reduce stiffness in the~     upper limbs and has been shown to be ineffective in PD. To date, it is unknown how neural~     networks change as a result of consolidation after a prolonged period of motor learning in~     PD. Therefore the second arm of this study will investigate, for the first time, changes in~     neural connectivity using brain imaging data to elucidate which neuroanatomical regions are~     involved in consolidation of learning in PD. Finally, DTI and resting state fMRI-analysis~     will complement insights into the neural changes as a result of learning.~   "
97727|NCT02288039|"~     The main aim of pulmonary rehabilitation is to improve the quality of life of patients that~     have been diagnosed with chronic lung disease. The challenge for pulmonary rehabilitation is~     that many patients do not complete their agreed or prescribed training targets which may be~     related to the way pulmonary rehabilitation is delivered. There is a belief among doctors and~     other healthcare professionals delivering pulmonary rehabilitation care that patients who are~     working together as part of a group may better accomplish their agreed training targets~     (intervention). The intervention aims to encourage members of the group to interact and~     support each other during the rehabilitation sessions in order to attain agreed pulmonary~     rehabilitation goals~   "
97728|NCT02288026|"~     The purpose of this study is to compare early-stage peripheral non-small cell lung cancer~     lobectomy and sub-lobectomy surgery to evaluate if sub-lobectomy is as feasible and effective~     for the treatment of early-stage (diameter ≤2cm) peripheral non-small cell lung cancer as~     lobectomy.~   "
97729|NCT02288013|"~     Comparative study of the surgical outcome of 2-layers closure technique of uterine incision~     in Cesarean section using bidirectional barbed suture (Stratafix) and conventional suture~     material (Vicryl) regarding the time of closure and the need of secondary additional suturing~     or tearing of uterine muscles during suturing.~   "
97730|NCT02288000|"~     The early assessment of new drugs for Alzheimer's disease remains difficult because of the~     lack of predictive end-point. The use of a battery including different parameters could~     improve this early development of new drugs. Nevertheless, the interest of such a battery~     should previously be validated with the yet marketed AD drugs.~   "
97731|NCT02287987|"~     Prospective, randomized trial comparing surgical, functional and oncological outcomes between~     clamp and clamp-less robot assisted partial nephrectomy.~   "
97732|NCT02287974|"~     To study the effect of the stem cells therapy autologous mononuclear from the bone marrow,~     autologous progenitor endothelial CD133 cells from the bone marrow and autologous mesenchymal~     stem cells from adipose tissue on the inflammatory cytokines, the resistance to insulin and~     the decrease of the needs of insulin, besides evaluates the safety, viability and efficiency~     of the intra-arterial infusion of stem cells in diabetic patients type 2 with CLI.~   "
97733|NCT02287961|"~     Multicentric epidemiological non-comparative study in France characterising evolution of anal~     Human papillomavirus (HPV) infection and related lesions and evaluating markers associated~     with the observed evolution.~      Estimated enrolment: 500~      Principal Outcomes~        -  Detection of high-grade cytological and histological anal lesions by high resolution~          anoscopy~        -  Spontaneous regression of high-grade anal lesions~        -  Detection of anal HPV infection~      Intervention (procedure):~        -  Patient medical interview (initial inclusion visit, Month 12 and Month 24 follow-up~          visits and if applicable Month 6 and Month 18 control visits)~        -  Standard proctologic examination with digital rectal examination and 2 anal swabs~          (initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable Month~          6 and Month 18 control visits)~        -  High resolution anoscopy (initial inclusion visit, Month 12 and Month 24 follow-up~          visits and if applicable Month 6 and Month 18 control visits)~      Only if lesion suggestive of Anal Intraepithelial Neoplasia (AIN) detected during High~     Resolution Anoscopy (HRA):~      - anal biopsy(ies) during HRA~      Only if high-grade lesion:~      - HRA biannually~   "
97734|NCT02287948|"~     Balance disorders are frequently observed in patients with Multiple Sclerosis (MS) and the~     deterioration of the static and dynamic control of balance is an important and basic symptom~     of disease progression.~      Measure balance disorders with force platforme requires personnel and represent a significant~     cost.~      The platform Nintendo Wii Fit represents a valid economic alternative~   "
97735|NCT02287935|"~     It was investigated whether there is a factor that can aid determination of the preferred~     technique by comparing the early Limberg flap and Karydakis procedure techniques for the~     treatment of recurrent pilonidal sinus.~   "
97736|NCT02287922|"~     The primary objective of this study is:~      - To assess the efficacy and safety of dose regimens of ALX-0061 monotherapy administered~     subcutaneously (s.c.) to subjects with active rheumatoid arthritis (RA).~      The secondary objectives of this study are:~        -  To assess the effects of ALX-0061 on quality of life, the pharmacokinetics (PK),~          pharmacodynamics (PD), and immunogenicity of ALX 0061 and to explore potential dose~          regimens for ALX 0061 monotherapy, based on safety and efficacy, for further clinical~          development.~        -  To obtain parallel descriptive information concerning the efficacy and safety of~          tocilizumab (TCZ) s.c. in the same clinical trial RA population.~   "
97777|NCT02287389|"~     The purpose of this study is to evaluate the efficacy and safety of four interventional~     pulmonology techniques for the treatment of fibrotic central airway stricture.~      The four techniques are：~        -  balloon dilation~        -  balloon dilation plus cryotherapy~        -  balloon dilation plus spiculiform electrosurgery~        -  balloon dilation plus mitomycin C injection~   "
97798|NCT02287116|"~     The investigators aimed to compare the effectiveness of nasal mask and prongs used in CPAP~     (nasal continuous positive airway pressure)as the initial respiratory support when using~     minimal ly invasive surfactant therapy (MIST) in preterm infants.~   "
97737|NCT02287909|"~     The recommended antiplatelet treatment regimen for patients affected by acute coronary~     syndromes (ACS) and those undergoing percutaneous coronary intervention (PCI) consists in the~     combination of aspirin and a P2Y12 receptor inhibitor. More potent P2Y12 receptor inhibitors,~     such as ticagrelor, have been developed which are associated with less response variability~     than clopidogrel and better clinical outcomes. Ticagrelor use has increased significantly~     because of its more expanded Food and Drug Administration (FDA) indications compared with~     prasugrel. However, despite the evidence for sustained efficacy and safety, many physicians~     limit treatment duration with ticagrelor to the early phases following an ACS mostly due to~     cost issues and concerns about increased bleeding. Therefore, it is very common in clinical~     practice to switch patients while on maintenance dosing (MD) with ticagrelor to treatment~     with clopidogrel. However, the pharmacodynamic (PD) effects of switching from ticagrelor to~     clopidogrel remain unknown. Therefore, the aim of this investigation is to evaluate the PD~     effects of switching from ticagrelor to clopidogrel.~   "
97738|NCT02287896|"~     The aim of this study is to assess the pharmacokinetic profile of Roledumab 300μg IM / IV in~     RhDnegative pregnant women carrying an RhD-positive foetus.~      And to assess the safety of Roledumab in RhD-negative pregnant women and in RhD-positive~     foetus and newborns.~      In addition the efficacy of Roledumab 300μg IM and IV to prevent RhD alloimmunisation in~     RhDnegative pregnant women carrying an RhD-positive foetus and the immunogenicity of~     Roledumab will be assessed.~   "
97739|NCT02287883|"~     The investigators will study the delivery of care to patients with diabetes and~     cardiovascular diseases from 16 practices in health care organizations who receive incentives~     for improving the quality of patient care. Half of those will be far along in engaging~     patients in their care and half will not. The investigators will see whether patients with~     diabetes or cardiovascular diseases who receive care from practices that more fully involve~     their patients have better clinical outcomes and satisfaction with their care than those who~     do not. The investigators expect that these findings will help practices and patients to~     achieve better outcomes of care.~   "
97740|NCT02287870|"~     Chinese made chloroprocaine has a rapid onset time, effective methodology, can last for a~     short time, provides fast motor recovery and causes no significant side effects.~   "
97741|NCT02287857|"~     The purpose of this study is to evaluate the safety and efficacy of Domestic Tenofovir~     Disoproxil Fumarate Tablets in Chinese patients with hepatitis B ,compared with Tenofovir~     Disoproxil Fumarate Tablets of Gilead.~   "
97742|NCT02287844|"~     The purpose of the present study was to establish the prebiotic effect of a new~     xylo-oligosaccharides (XOS) and of an inulin-and-XOS mixture (INU-XOS) and to determine their~     effect on endotoxaemia (lipopolysaccharides (LPS)) and immune parameters. In this randomized,~     parallel, placebo-controlled, double-blind study, sixty healthy volunteers were randomly~     assigned to three groups, receiving either 5 g XOS, INU-XOS (3 g inulin +1 g XOS) or an~     equivalent weight of wheat maltodextrins (placebo) during 4 weeks.~   "
97743|NCT02287831|"~     The purpose of this study is to assess the safety and efficacy of umbilical cord mesenchymal~     stem cells in diabetes with peripheral arterial disease.~   "
97744|NCT02287818|"~     AC-201CR is a control released formulation of AC-201 that in previous clinical studies showed~     potential dual effects in both reducing serum uric acid (sUA) and gout flares. The mechanism~     of actions of AC-201 include the inhibition of the production and activity of caspase-1 and~     interleukin-1β (IL-1β), and selective inhibition of re-absorption transporters in kidney. The~     goal of gout treatment is to reduce serum uric acid (sUA) concentrations below the urate~     solubility limit while avoiding acute gout flares. However, the initiation of urate-lowering~     therapy (ULT) increases the occurrence of acute gouty arthritis flares. IL-1β plays a key~     role in mediating this inflammatory response. The study is designed to test the~     urate-lowering effect, safety, and tolerability of AC-201CR in an initial dosing period,~     followed by addition of an ULT to test the efficacy and safety of the combination and~     prophylaxis of gout flares during ULT.~   "
97745|NCT02287805|"~     The purposes of this study are:~        -  to better understand the experience of the announcement for the diagnostic of~          craniosynostosis to patients and their families to improve the understanding of it and~          it modes of appropriation~        -  to compare the announcement process concerning simple and complex forms.~        -  to identify the intra-family issues at the announcement of a genetic mutation.~        -  to reconstruct the care course of patients by analyzing the time of the announcement and~          the post-operative period.~   "
97746|NCT02287792|"~     The purpose of this study is to assess the impact of 18-FDG positron emission tomography~     (PET)/computed tomography (CT) imaging in the management of patients with suspected or proven~     IE in detecting cardiac valve damages and other extracardiac complications. The study will~     evaluate whether this procedure can change the clinical decisions (treatments, valve surgery,~     patients' overall care) and modify the diagnosis of IE.~   "
97747|NCT02287779|"~     This study will investigate the safety and tolerability of daily dosing regimens of SHP626 in~     overweight and obese adults.~   "
97748|NCT02287766|"~     The objective of this study is to determine whether the finger tip images captured by the~     EPIC ClearView device, when analyzed via the ClearView software, produce a Response Scale~     that characterizes trends consistent with Metabolic Syndrome identified by medical doctors.~   "
97749|NCT02287753|"~     The purpose of this study is to evaluate the ability of vascular occlusion test (VOT) during~     cardiac surgery to predict postoperative outcomes in pediatric patients.~   "
97750|NCT02287740|"~     Objective: To conduct a comparative efficacy and cost-effectiveness study of an~     evidence-based fall prevention program—Tai Ji Quan: Moving for Better Balance (TJQMBB).~   "
97751|NCT02287727|"~     This phase II trial studies how well regorafenib works in reducing the return of disease in~     patients with rectal cancer that has not spread to another place in the body who have~     completed curative-intent treatment. Regorafenib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Regorafenib may also help keep cancer~     from coming back after it has disappeared following the initial therapy.~   "
97752|NCT02287714|"~     Compare results of Instep Plantar Fascial release with and without gastrocnemius recession~   "
97753|NCT02287701|"~     The overarching goal of this project is to explore whether associations exist between metrics~     obtained from PET/MRI incorporating advanced MRI sequences and features of bladder cancer,~     including grade, stage, and treatment response.~   "
97754|NCT02287688|"~     This safety surveillance study of Novartis quadrivalent meningococcal ACWY conjugate vaccine~     (Meningococcal quadrivalent CRM-197) among children 2 months through 23 months of age is a~     post-marketing study required by the United States Food and Drug Administration.~      It is an observational study of children 2-23 months of age who receive at least one dose of~     MenACWY-CRM vaccine at a Kaiser Permanente Southern California facility (KPSC) while enrolled~     as a KPSC health plan member.~      The objective of the infant study is to describe medical events that require emergency room~     visit or hospitalization in 6 months following MenACWY-CRM vaccination in children 2-23~     months of age in a health maintenance organization in the United States. Outcomes include~     medical events that require emergency room visits or hospitalizations in children 2-23 months~     of age following any dose of MenACWY-CRM vaccination. Events with a history of the same~     diagnosis prior to the first dose of MenACWY-CRM vaccination will be excluded as a~     pre-existing condition.~   "
97755|NCT02287675|"~     To compare the kinetics and efficacy of two functionally different diagnostic agents,~     Lymphoseek (CD206 receptor targeted) and 99mTc-SC (Sulfur Colloid non-specific mapping agent)~     in intraoperative lymphatic mapping (ILM) and Sentinel Lymph Node Biopsy (SLNB).~   "
97756|NCT02287662|"~     The primary objective of this study is to determine the efficacy, safety and feasibility of~     next day discharge home in patients undergoing balloon-expandable transfemoral TAVR utilizing~     the Vancouver 3M Clinical Pathway in low, medium, and high volume North American centres.~   "
97757|NCT02287649|"~     Aims of the study : 1) To determine whether the presence of the V158 allele of Fc gammaRIIIA~     gene is associated with a better outcome of Immune Thrombocytopenia (ITP) in adults and~     especially with a higher response-rate to rituximab. 2) To analyze the impact of therapy and~     especially rituximab on some B and T cells autoreactive subsets in the peripheral blood.~      Patients and Methods :~      Inclusion criteria : age ≥ 18 years, primary ITP defined according to the recent consensual~     criteria (Rodeghiero F et al. Blood 2009), active ITP defined as an ITP with a platelet count~     < 50 x 109/L requiring treatment, informed consent. Main exclusion criteria : secondary ITP.~      Blood samples (serum, plasma, DNA) will be collected in every patient at time of inclusion~     (pre-treatment) and then sequentially at 3, 6 and 12 months after inclusion in patients~     treated with rituximab or during the remission phase for other treatments for immunological~     studies. When a marrow analysis is indicated, some marrow specimens will also be collected~     and studied and if a patient will have to undergo a splenectomy as a standard of care, some~     spleen specimens will also be collected. Fc gamma RIIIA V/F158 polymorphism will be assessed~     by means of an allele-specific PCR. The sequential analysis of anti-platelets~     (anti-GpIIbIIIa) antibodies producing B cells will be performed by means of flow cytometry~     and ELISPOT analysis. T cells subsets will be harvested in presence of GpIIbIIIa~     immunodominant peptides and and cytokines expression will be measured on supernatants on days~     2 and 11 in vitro by using Luminex technology in order to characterize and distinguish TH1,~     TH2, TH17, TFH and Tregs subsets.~      The primary outcome will be the overall response rate 1 year after inclusion defined by a~     platelet count > 30 x 109/L with at least a two-fold increase of the initial (pre-treatment)~     count. For the patients treated with rituximab as a standard of care, based on the overall~     expected response-rate (40-50%) and based on preliminary data on FcgammaRIIIA V/F158~     distribution, the inclusion of 85 patients should be sufficient to show an association of the~     V158 allele and the response (b risk 20% and a 5%). Responders and non responders will be~     compared by non parametrical tests, a multivariate analysis will be than performed using a~     logistic regression model. The immunological data B and T cells subsets) obtained in both the~     responders and the non responders will be compared over time (To, M3, M6 and M12) by non~     parametrical matched tests.~   "
97758|NCT02287636|"~     This pilot clinical trial studies how well positron emission tomography (PET)/magnetic~     resonance imaging (MRI) works compared to PET/computed tomography (CT) in diagnosing younger~     patients with cancer. PET/MRI and PET/CT are procedures that combine the pictures from a PET~     scan and an MRI scan or a CT scan. The PET and MRI scans or PET and CT scans are done at the~     same time with the same machine. The combined scans give more detailed pictures of areas~     inside the body than either scan gives by itself. It is not yet known whether PET/MRI works~     better than PET/CT in diagnosing younger patients with cancer.~   "
97759|NCT02287623|"~     The primary objective of this study is whether one local anesthetic, liposomal bupivacaine,~     provides improved pain control and decreased opioid use compared to bupivacaine when injected~     during a transversus abdominis plane block for donor nephrectomy patients.~   "
97760|NCT02287610|"~     The overall objective of the study is to assess the effectiveness of switching from~     immediate-release prednisone (conventional) therapy to delayed-release prednisone (RAYOS) in~     patients with moderately to severely active Rheumatoid Arthritis (RA), managed according to~     standard of care in clinical practice settings.~   "
97761|NCT02287597|"~     This local, non-interventional, cohort study of patients with metastatic colorectal cancer~     (mCRC) will prospectively collect data from standard clinical practice of second-line~     treatment with chemotherapy plus Avastin (bevacizumab). There will be no additional~     diagnostic or therapeutic procedures required by this study, apart from those performed in~     everyday clinical practice for second-line treatment of mCRC in Croatia.~   "
97762|NCT02287584|"~     The primary objective of the study is to evaluate the efficacy of DSP-5423P compared with~     placebo in patients with schizophrenia.~   "
97763|NCT02287571|"~     The aim of this prospective, randomized controlled trial is to compare the effects of~     preoperative skin traction and position splint on pain, comfort, complications, difficulty~     level of nursing interventions, satisfaction from treatment and nursing care in patients with~     hip fracture. The sample is comprised of 34 patients with hip fracture in each group, totally~     68 patients. Skin traction and position splint were applied after block randomization. Data~     regarding pain, comfort, satisfaction from care, immobilization comfort, complications, time~     of operation and hospitalization time were collected after intervention.~   "
97764|NCT02287558|"~     This study will evaluate patients > 18 years of age with transfusion-dependent~     gastrointestinal bleeding due to documented gastrointestinal vascular ectasia with or without~     concurrent hereditary hemorrhagic telangiectasia (HHT). This study will focus on documented~     bleeding sites in the small bowel, including the duodenum, jejunum and ileum. Eligible~     patients will have endoscopically-documented sites of vascular ectasia and will have required~     at least 4 units of blood transfusion or episodes of intravenous iron administration over the~     preceding four months.~   "
97765|NCT02287545|"~     Corneal biomechanics are studied in glaucoma patients prior and at least 6 month after~     trabeculectomy.~   "
97778|NCT02287376|"~     Study Objectives:~        1. The primary objective is to characterize the pharmacokinetics of a single oral~          administration of 50 mg Cambia in pediatric subjects, ages 12-17 years with a diagnosis~          of episodic migraine with or without aura.~        2. The secondary objectives are to determine:~             1. The safety and tolerability of Cambia from a single dose~             2. Three-month safety evaluation of Cambia in outpatient usage in this population~   "
98388|NCT02279394|"~     This research study is aimed to determine the proportion of high risk smoldering multiple~     myeloma patients who are progression free at 2 years after receiving elotuzumab, lenalidomide~     and dexamethasone combination therapy.~   "
97768|NCT02287506|"~     There are three main forms of diabetes: Type 1 diabetes, Type 2 diabetes and genetic~     diabetes. The treatment for each is very different because they have different causes. People~     with Type 1 diabetes stop making their own insulin, so need insulin injections instead,~     whereas people with Type 2 diabetes can keep making their own insulin but it may not work as~     well as it should, so they need to watch what they eat, and may also need tablets or~     eventually insulin injections. Genetic forms of diabetes have specific treatments according~     to the subgroup.~      It is not easy for doctors to be able to say for definite what kind of diabetes a person has,~     particularly in young adults, where the distinction between the types is less clear. Because~     of this, sometimes (in about 10% of cases) people are given the wrong diagnosis. This can~     have a huge impact as it means they could be on the wrong treatment from the start, so they~     cannot control their blood sugars properly, which can lead to increased problems with their~     health and poor quality of life.~      We think we have a way of improving this situation. We have developed a tool called an~     Optimised Diagnostic Strategy (ODS). This combines a person's clinical features (such as~     their age and weight), with blood tests looking for changes in their body's immune (defence)~     system, and a blood test looking for specific changes in their genetic code, to help~     accurately diagnose what kind of diabetes that person has. We now need to test this ODS to~     see if it is better at getting the right diagnosis and treatment from the start compared with~     what we do in routine clinical practice at the moment. This kind of project is called a~     Randomised Controlled Trial (RCT) and would involve patients from General Practitioner (GP)~     surgeries all over the United Kingdom (UK). The project would be expensive as it involves a~     lot of work by many people to get it set up and to keep it running. Before we can do this we~     need to do a pilot to see if the bigger study would be possible and practical to do. This~     pilot project will be done locally in Exeter and test all the parts needed for the larger~     scale RCT.~   "
97769|NCT02287493|"~     In a prospective, non-interventional, monocentric observational study the pharmacokinetic~     properties of selected antiinfective drugs during sustained low-efficiency dialysis (SLED)~     will be analyzed.~      Plasma specimens will be quantified using high Performance liquid chromatography (HPLC).~      Primary endpoint: Plasma levels of antiinfectives during SLED~      Secondary endpoints:~        -  28-day-mortality~        -  length of stay at the intensive care unit (ICU) and in hospital~        -  clinical and microbiological cure of infections~      Inclusion criteria:~        -  age: > 18 years~        -  patients under SLED~        -  antiinfective treatment~      exclusion criteria:~      - missing informed consent~   "
97770|NCT02287480|"~     The hemorrhagic fever resulting from Ebola infection is frequently fatal; the current Ebola~     outbreak, still in its ascendant phase, has a mortality rate over 50%. There is no proven~     therapy or prevention available at this time.~      The vaccine candidate VSV-ZEBOV (BPSC1001) has shown promising safety and efficacy in~     preventing Ebola Zaire infections in non-human primates (NHP). Before it can be assessed in~     large Phase IIb/3 trials in affected areas, safety data from phase 1 first-in-human trials~     are needed. To accelerate this process, the World Health Organization (WHO) has constituted a~     consortium of Clinical Research Centers in Switzerland, Germany, and Africa that will use~     similar protocols to collectively include roughly 250 volunteers, the sample size required to~     identify a 2-fold difference in anti-ZEBOV IgG antibody titers following immunization with 2~     different doses of BPSC1001.~      The joint primary objectives of this single-center, double-blind, randomized~     placebo-controlled phase 1 dose-finding study are to assess the safety and tolerability of~     the VSV-ZEBOV vaccine when administered to healthy volunteers at a lower or higher vaccine~     dose and to define whether seroresponses differ significantly following immunization with the~     lower or higher vaccine dose.~   "
97771|NCT02287467|"~     Influenza (the flu) is a common illness that usually occurs in autumn and winter. The flu is~     usually mild, but can cause serious illness or death. The purpose of this study is to test~     the safety and effectiveness of an antibody against the flu (called intravenous hyperimmune~     immunoglobulin or IVIG) in people who are hospitalized for severe flu.~   "
97772|NCT02287454|"~     The study design was a parallel-group randomized trial with equal randomization. Recruitment~     and enrollment were conducted between January 2013 and March 2013. At base-line, cognitive~     data was collected. Afterwards, the participants were randomly allocated to either the~     REHACOP group or the Control group. During 3 months the intervention with REHACOP program~     took place and at follow-up patients were again re-evaluated to evaluate the change in~     cognitive measure. Post-treatment assessment (finished by July 2013) was performed within the~     first week after completing the intervention. Optional enrollment in pre-post neuroimaging~     will also allow us to look at changes in the brain.~      Objective: To examine the efficacy of an integrative cognitive training program (REHACOP) to~     improve cognition of patients with Multiple Sclerosis (MS).~   "
97773|NCT02287441|"~     The objective of this study is to determine if differences exist in the total vegetable~     intake of groups that eat either tomato products versus raw vegetable product.~   "
97774|NCT02287428|"~     This research study is studying a new type of vaccine as a possible treatment for patients~     with MGMT-unmethylated glioblastoma. This research study is a Phase I clinical trial, which~     tests the safety of an investigational intervention and also tries to define the appropriate~     dose of the intervention to use for further studies. Investigational means that the~     intervention is being studied and that research doctors are trying to find more about it. It~     also means that the FDA (U.S. Food and Drug Administration) has not approved the Personalized~     NeoAntigen Cancer Vaccine for any use in patients, including people with glioblastoma.~      The purpose of this study (Cohort 1) is to determine if it is possible to make and administer~     safely a vaccine against glioblastoma by using information gained from specific~     characteristics of the participants tumor. It is known that glioblastomas have mutations~     (changes in genetic material) that are specific to an individual patient's tumor. These~     mutations can cause the tumor cells to produce proteins that appear very different from the~     body's own cells. It is possible that these proteins used in a vaccine may induce strong~     immune responses, which may help the body fight any tumor cells that could cause the~     glioblastoma to come back in the future.~      Two additional cohorts (1a and 1b) will be included in the study following completion of~     accrual to the original study cohort (cohort 1). Each additional cohort will receive NeoVax~     and radiation therapy as administered to cohort 1 and will also receive pembrolizumab. Cohort~     1b will also receive standard temozolomide during radiation and as adjuvant therapy following~     completion of radiation therapy.~   "
97775|NCT02287415|"~     Multiple-dose, open-label, single-period study consisting of three consecutive phases~   "
97776|NCT02287402|"~     The purpose of open-label study is to evaluate the efficacy and safety of AO-128 (Voglibose)~     0.6 mg/day in patients with impaired glucose tolerance (IGT) who had been non-responsive to~     diet therapy and exercise therapy, and follow up the progress after the end of treatment in~     patients who was assessed as normoglycemic.~   "
98412|NCT02279082|"~     A multi-center, open-label, safety study of DFN-02 for the Treatment of Acute Migraines~   "
97783|NCT02287311|"~     The subject has a type of lymph gland disease called Hodgkin Disease (HD) or non-Hodgkin~     Lymphoma (NHL), T/NK-lymphoproliferative disease or severe chronic active Epstein Barr Virus~     (CAEBV) which has come back, is at risk of coming back, or has not gone away after treatment,~     including the best treatment we know for these diseases. This research study uses special~     immune system cells called LMP, BARF-1 and EBNA1- specific cytotoxic T lymphocytes (MABEL~     CTLs).~      Some patients with Lymphoma, T/NK-lymphoproliferative disease, or CAEBV show signs of a virus~     called Epstein Barr virus (EBV) that causes mononucleosis or glandular fever (mono or the~     kissing disease) before or at the time of their diagnosis. EBV is found in cancer cells of~     up to half the patients with HD and NHL, suggesting that it may play a role in causing~     Lymphoma. The cancer cells (in lymphoma) and some immune system cells (in CAEBV) infected by~     EBV are able to hide from the body's immune system and escape destruction. We want to see if~     special white blood cells (MABEL CTLs) that have been trained to kill EBV infected cells can~     survive in your blood and affect the tumor.~      In previous studies, EBV CTLs were generated from the blood of the patient, which was often~     difficult if the patient had recently received chemotherapy. Also, it took up to 1-2 months~     to make the cells, which is not practical when a patient needs treatment more urgently. To~     address these issues, the T cells in the current study were made in the laboratory in a~     simpler, faster, and safer way. The T cells we have made will still see LMP proteins but also~     two other EBV proteins called EBNA-1 and BARF. These cells are called MABEL CTLs. In order to~     ensure these cells are available for use in patients in urgent clinical need, we have~     generated MABEL CTLs from the blood of healthy donors and created a bank of these cells,~     which are frozen until ready for use. We have previously successfully used frozen T cells~     from healthy donors to treat EBV lymphoma and virus infections and we now have improved our~     production method to make it faster.~      In this study, we want to find out if we can use banked MABEL CTLs to treat HD or NHL,~     T/NK-lymphoproliferative disease and severe chronic active Epstein Barr Virus (CAEBV). We~     will search the bank to find a MABEL CTL line that is a partial match with the subject.~   "
97784|NCT02287298|"~     We propose to undertake a retrospective review of approximately 200 patients with a diagnosis~     of exudative macular degeneration treated with triple combination therapy (Bevacizumab,~     Dexamethasone and Photo-dynamic therapy) during the years of 2006 to 2010 at The Retina~     Center and compare those results with an additional group of approximately 200 patients also~     treated with triple combination therapy and 20 mg of daily oral zeaxanthin.~   "
97785|NCT02287285|"~     Longitudinal study of beta cell function up to 2 years after GBP surgery. Evaluation of the~     role of endogenous glucagon-like peptide-1 (GLP-1).~   "
97786|NCT02287272|"~     The purpose of this study is to evaluate the pharmacokinetic interaction when CHF5993~     (pressurized metered-dose inhaler (pMDI) is administered with Cimetidine (probe inhibitor of~     the organic cation transport in the kidneys), by comparing the systemic exposure (AUC0-t) of~     Glycopyrronium Bromide (GB), after a single dose of the fixed combination CHF 5993 pMDI~     administered alone or at steady-state of Cimetidine~   "
97787|NCT02287259|"~     Determine the efficacy and tolerability of olanzapine for treatment of acute depression in~     patients with bipolar II or bipolar disorder NOS compared with lithium.~   "
97788|NCT02287246|"~     To study post-operative efficacy of Exparel® for pain control in patients undergoing any~     Urogynecology surgery involving the posterior vaginal wall using a randomized, double-blinded~     placebo controlled trial.~   "
97789|NCT02287233|"~     This study consists of two portions: The first portion- Phase 1, or dose-escalation portion,~     that will evaluate the safety and pharmacokinetic profile of venetoclax in combination with~     low-dose cytarabine (LDC), define the maximum tolerated dose (MTD), and generate data to~     support a recommended Phase 2 dose (RPTD) in treatment-naïve subjects with Acute Myelogenous~     Leukemia (AML). Second portion, initial Phase 2 that will evaluate if the RPTD has sufficient~     efficacy and acceptable toxicity to warrant further development of the combination therapy.~     Subsequently, Phase 2 Cohort C, will evaluate the overall response rate (ORR) for subjects~     allowed additional supportive medications (strong CYP3A inhibitors) if medically indicated.~   "
97790|NCT02287220|"~     The purpose of this study is to test the accuracy of a web cam-based biomedical device~     developed at UVA (not FDA-approved) that is designed to measure heart rate, respiratory rate,~     and oxygen saturation without requiring any patient contact. One potential application of~     such a device would be in the field of infant monitoring allowing parents (and physicians) to~     monitor the vital signs of infants continuously. The investigators therefore propose to~     record the heart rate, respiratory rate, and oxygen saturation of 100 infants (defined as~     children aged 12 months or less) who are receiving continuous oxygen, heart rate, and~     respiratory rate monitoring with a traditional vital signs monitor. The relationship between~     non-contact and gold standard (GE monitoring equipment) heart rate, respiratory rate, and~     oxygen saturation will be analyzed using regression and limits of agreement analysis.~   "
97791|NCT02287207|"~     The purpose of this pilot study is to determine the effect of transcranial direct current~     stimulation (tDCS) on brain activity and fine motor skills in patients with Parkinson's~     disease compared to healthy controls.~   "
97792|NCT02287194|"~     To document indications for cholangioscopy and clinical utility of the SpyGlass Direct~     Visualization System in China when used per standard of practice.~      Prospective, Post market, Multi-center, Non-randomized Study~   "
97793|NCT02287181|"~     A prospective, randomised, phase IV trial including 150 patients.~      To evaluate the effects of varied concentrations of remifentanil on the proposal requirements~     for the loss of consciousness and response to pain and to evaluate the haemodynamic changes~     and processed EEG (BIS) during induction of anaesthesia.~   "
97794|NCT02287168|"~     Surgical manipulation and handling of a tumor may cause dissemination of cancer cells through~     peritoneal cavity after curative gastrectomy. Intra operative peritoneal lavage may have~     preventive effect on positive peritoneal cytology occurred during gastrectomy in patients~     with gastric cancer.~   "
97795|NCT02287155|"~     As in many other countries in the world, the population in Switzerland is growing older. This~     also means an expansion of costs in the health system. Therefore, the investigators need to~     find concepts of health promotion to prevent people from getting ill and dependent of the~     health care system.~      Our project aims at developing a health promotion program for persons over 50 years of age in~     a rural area of Switzerland. The program's name is bliib gsund. This occupational-therapy~     directed health promotion program is conducted over a period of six months in two groups of~     eight persons each. The aim of the program is to enhance the quality of life of the~     participants, to mediate the competence of integrating health-promoting aspects in their~     daily life, and to maintain their independence in their life as long as possible. Persons~     over 50 often find themselves in a phase of transition in life, such as starting retirement,~     the loss of family members or children moving out. This program will provide them with the~     ability to continue their lifestyle in a more active way. It embraces topics such as more~     active pursuits of interests and carrying out personally meaningful activities.~      In preparation of the program, the investigators conducted a needs analysis to identify the~     needs relating to health-promoting offers of the inhabitants living in the specified region.~     The results showed a high interest and need for such programs. They also helped us to~     identify several relevant issues to be included in the presented health-promotion program:~     physical exercise in daily life, healthy nutrition, getting acquainted with new technologies,~     fall-prevention training and maintaining social contacts. The researchers and the designated~     occupational therapist, who will be the moderator of the program, can develop the program~     based on these results.~      The evaluation of the program should identify the effect of the program concerning the~     promotion of self-efficacy, the sense of coherence, quality of life and the program~     objectives. A questionnaire will be distributed before the program, immediately after and six~     months after the program.~   "
97799|NCT02287103|"~     Background: Skipping breakfast and/or overeating at evening, has been associated in type 2~     diabetic (T2D) individuals, with higher BMI, visceral adiposity, hyperlipidemia, increased~     overall postprandial glycemia (PPHG) and higher HbA1c. The absence of breakfast is also~     associated with increased plasma free fatty acids (FFA) along the morning until lunch. High~     plasma FFA in turn are triggering factor of insulin resistance, by inhibiting insulin~     mediated glucose uptake in obese and T2D subjects The investigators therefore hypothesize~     that compared to eating breakfast the prolonged overnight fasting caused by the breakfast~     omission will result in increased postprandial glycemic response after subsequent isocaloric~     lunch and dinner in T2D individuals.~      Objectives: With this aim will study T2D patients in randomized crossover design to consume~     in two separate days, either 3 standard isocaloric meals: Yes Breakfast condition (YesB) or~     omit breakfast: no breakfast condition (NoB) and consume only lunch and dinner with the same~     caloric content.~      Methods and Study Design: The YesB intervention will consist on three identical meals coating~     700 Kcal each: breakfast at 8:00, lunch at 13:00 and dinner at 19:00. The NoB intervention~     the breakfast will be omitted and the subject continue fasting until lunch. Then the~     participants will consume identical 700 kcal Lunch at 13:00 and 700 Kcal dinners at 19:00.~     The investigators will assess plasma glucose, insulin, C-peptide, GLP-1 and FFA with blood~     samples collected every 30 min up to 180 min after breakfast, lunch and dinner and at the~     same time point the blood samples will be collected after 8:00 when the breakfast will be~     omitted.~      Expected results: The investigators expect that compared to NoB condition, in the YesB~     condition the postprandial response after lunch and dinner will be reduced for glucose and~     for FFA, while plasma insulin, C-peptide and GLP-1 postprandial response after lunch and~     dinner will be enhanced~   "
97800|NCT02287090|"~     Rotator cuff tears are one of the most common causes of shoulder pain. Evidence-based~     guidance on optimal diagnostic and treatment strategies for rotator cuff tears is lacking.~     Our proposed study aims to fill these gaps by identifying the prognostic factors which will~     predict better outcomes of rotator cuff tears, based on both operative and non-operative~     treatment. The investigators will also compare outcomes of operative and non-operative~     treatment of rotator cuff tears and report on the best way to diagnose rotator cuff tears.~   "
97801|NCT02287077|"~     The objective of this pilot study is to investigate the feasibility of performing umbilical~     cord milking in neonates who are depressed at birth.~   "
97802|NCT02287064|"~     The purpose of this study is to learn how Intravenous Immune Globulin (IVIG) will affect~     Spinocerebellar Ataxia (SCA) symptoms and how it will affect motor and nervous system~     function in participants Subtypes of SCA to be examined will include SCA types 1, 2, 3, 6, 10~     and 11.~   "
97803|NCT02287051|"~     Bowel preparation for colonoscopy is crucial, since the diagnostic accuracy of the procedure~     depends on an adequate visualization of the mucosa of the colon.There is strong evidence that~     the quality of bowel preparation is inversely correlated with the interval between the end of~     the assumption of the purgative and the start of colonoscopy (shorter intervals are~     associated with higher levels of preparation).Recent studies have shown that split dose prep~     significantly improves the quality of bowel cleansing. In light of these data, both the~     American College of Gastroenterology (ACG) and the European Society of Gastrointestinal~     Endoscopy (ESGE) recommend now split dose prep in order to improve the quality of bowel~     cleansing. Despite these recommendations, the uptake of schemes in divided doses appears~     clearly underused in actual clinical practice. In particular, in Italy only a few centers~     routinely adopt the regime split as their first choice for the preparation for~     colonoscopy.The reasons why the split dose is under-utilized in clinical practice are not~     entirely clear, but probably in part reflecting gastroenterologists' concerns about potential~     elements that theoretically could make it less acceptable to the patient (get up early in the~     morning, potential problems during the journey from home to the hospital) The hypothesis of~     the study is that many patients would still be willing to accept these potential drawbacks if~     they were adequately informed about the positive impact of the scheme in divided doses on the~     effectiveness of bowel preparation, which results in higher reliability of the examination,~     shorter duration of the procedure, and less risk of rescheduling the exam in the near future~   "
97804|NCT02287038|"~     The current available treatments for PTSD are not fully effective for cognitive symptoms of~     PTSD and have high drop-out and poor engagement, two factors found to be most indicative of~     overall return to functioning for patients with PTSD. Successful completion of this pilot~     clinical trial may build a platform for future large scale double-blind, placebo-controlled~     studies using either atomoxetine or psycho-stimulants or other cognitive enhancing~     medications. The response inhibition related measurements are sensitive to psychotropic~     medications. Therefore it is advantageous for us to use GNG and Stop Signal approaches to~     investigate individual treatments response in the investigators' future research. The~     investigators believe GNG and Stop signal approaches together with pharmacogenetic approach~     will provide valuable information to direct future individualized medicine.~   "
97805|NCT02287025|"~     Randomized trial to evaluate impact of healthcare provider( clinician and nursing staff)~     support and education on treatment discontinuation rates in the absence of progression in~     patients with metastatic colorectal cancer treated with regorafenib. Intensified education~     and support will be provided through an application for iPad which has automatic links to~     grading, dose reduction and side effect management ,as well as, references for additional~     articles.~   "
97806|NCT02287012|"~     This study aims to observe the effects of the availability of plerixafor on the time and~     effort associated with autologous peripheral blood stem cell collection.~   "
97807|NCT02286999|"~     The purpose of this study is to investigate the dose of a probiotic supplement~     (Bifidobacterium longum subsp. infantis) required to achieve predominant gut colonization in~     healthy newborn, breastfed infants. The study will also examine whether supplementation with~     this probiotic can reduce the chance of developing eczema and food allergies in enrolled~     infants.~   "
97808|NCT02286986|"~     Part A: To evaluate the safety and tolerability of multiple ascending doses of GWP42003-P~     compared with placebo with respect to:~        -  Incidence, type and severity of adverse events (AEs)~        -  Effect on vital signs, including weight~        -  Effect on 12-lead electrocardiogram (ECG) findings~        -  Effect on laboratory parameters Part B: To make an assessment of the anti-epileptic~          efficacy of GWP42003-P compared with placebo with respect to the incidence in convulsive~          seizures~        -  To determine the plasma concentration time curves for GWP42003-P and its major human~          metabolite, following escalating multiple doses of GWP42003-P.~        -  To investigate the effect of GWP42003-P on the pharmacokinetics of concomitant~          anti-epileptic drugs (AEDs).~        -  To evaluate cognitive function, sleep quality and daytime sleepiness, in patients taking~          GWP42003-P in combination with AEDs.~   "
98451|NCT02278575|"~     The study will be an open controlled pilot study of 6 patients with early-onset severe~     preeclampsia. Patients will receive Atenativ in addition to conventional therapy The patients~     will be followed up within the study until three days after delivery. Laboratory analyses and~     uterine and umbiliacal blood flow will be determined.~   "
97809|NCT02286973|"~     This prospective randomized controlled trial was conducted To compare the efficacy of TNA in~     terms of total blood loss and the allogenic transfusion rate among the three study groups;~     intravenous alone, combined intravenous and low dose topical TNA and combined intravenous and~     high dose topical TNA.~      To evaluate the safety of each regimen in view of deep vein thrombosis and venous~     thromboembolism.~   "
97810|NCT02286960|"~     Despite the considerable use of oral steroids in the regular management of benign vocal fold~     lesions there is little evidence base in the literature. This study will investigate the~     efficacy of oral steroids for the treatment of vocal fold lesions in a controlled manner. The~     specific aim of this study is to determine the effectiveness of of a short course of oral~     steroids prior to behavioral voice therapy in patients with benign, phonotraumatic vocal fold~     lesions. Enrolled subjects will be randomized using a random numbers table to either receive~     oral steroids or no steroids prior to the initiation of voice therapy. The therapist and~     individuals involved in the collection and analysis of data will be blinded as to whether the~     subject received drug. Prior to initiation of therapy subjects will be asked to return for an~     interval evaluation during which they undergo videostroboscopy and voice evaluation. Subjects~     will enter then the voice therapy phase . After an initial evaluation to determine the best~     mode of therapy they will receive a behavioral voice therapy course, which includes a range~     of behavioral modifications and motor learning techniques, along with lifestyle measures. In~     all these phases acoustic and aerodynamic measurements will be collected as well as~     audio-visual material from the videostroboscopic exams. The investigators hypothesize that~     oral steroids will lead to a reduction in lesion size, which will substantially aid in the~     delivery and incorporation of voice therapy techniques, contributing to the improvement of~     overall laryngeal biomechanics and providing an ideal starting point for behavioral voice~     therapy.~   "
97811|NCT02286947|"~     The primary objective of this study is to explore safety and tolerability of eteplirsen in~     participants with advanced stage Duchenne muscular dystrophy (DMD) who are amenable to exon~     51 skipping.~   "
97812|NCT02286934|"~     A Clinical Study to Evaluate the Effect of Cytochrome P450 2D6 polymorphism on~     Pharmacokinetics/Pharmacodynamics After Multiple Administration of Carvedilol~   "
97813|NCT02286921|"~     Asymptomatic men with progressive metastatic CRPC post- treatment with abiraterone acetate~     (pre-chemotherapy for metastatic disease) will be treated on a randomized,~     multi-Institutional open label study to determine if treatment with intramuscular T given on~     a dose/schedule designed to result in rapid cycling from the polar extremes of~     supraphysiologic to near castrate levels [i.e. Bipolar Androgen Therapy (BAT)] will improve~     primary and secondary objectives vs. enzalutamide as standard therapy.~   "
97814|NCT02286908|"~     The aim of the study is to investigate if global strain and mechanical dispersion may predict~     death and ventricular arrhythmias better than ejection fraction(EF) in patients with~     myocardial infarction and heart failure regardless of cause.~   "
97815|NCT02286895|"~     This study is an evaluation of the immune response to pentavalent rotavirus vaccine (PRV)~     after a fourth dose is given at 9 months of age with local WHO Expanded Programme on~     Immunization (EPI) vaccines in Mali.~   "
97816|NCT02286882|"~     PF-06409577 is a new compound proposed for the treatment of diabetic nephropathy. The primary~     purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single~     oral doses of PF-06409577 in healthy adult subjects.~   "
97817|NCT02286869|"~     This study measures the cardioventilatory coupling in critically ill patients during~     mechanical ventilation in controlled mode (pressure controlled) and in patient-driven mode~     (pressure support and neurally adjusted ventilatory assist).~   "
97818|NCT02286856|"~     The m.3243A>G mutation is the most frequent cause of mitochondrial disease in adults, for~     which currently no therapy is available and treatment is solely supportive. Since both~     malnutrition and obesity are frequently seen in these patients, an adequate nutritional~     intervention to improve body composition and function might improve the quality of life of~     these patients.~      Hypothesis / research questions Hypothesis part 1: Patients with mitochondrial disorders~     caused by the m.3243 A>G mutation have an increased risk for malnutrition.~      Hypothesis part 2 : Intervention study: Dietary intervention in adults with a mitochondrial~     disorder caused by the m.3243 A>G mutation has a positive effect on nutritional status,~     activity, hand grip strength, body composition, food intake, fatigue and quality of life.~   "
97819|NCT02286843|"~     Some breast cancer cells make a protein called Human Epidermal Growth factor receptor 2~     (HER2). Patients with HER2 positive (HER2+) breast cancer receive medicine that attacks HER2,~     which helps these patients live longer. Some HER2 negative (HER2-) breast cancer patients~     also benefit from medicines that attack HER2, but we do not know why or which patients will~     benefit. This study uses a new imaging method, HER2-targeted PET/CT, to identify patients~     that may benefit from medicines that attack HER2. This is experimental.~   "
97820|NCT02286830|"~     Main hypothesis: Patients who continue zoledronic acid after year 2 have longer time until~     progression in bone disease compared to patients who stop treatment after two years?~      Secondary hypothesis: Serum will bone markers increase prior to progression in bone disease~     in the individual patient?~      Secondary hypothesis: Low-dose CT will detect more cases of osteolytic bone disease in~     Multiple Myeloma compared to conventional radiography~   "
97821|NCT02286817|"~     This trial is a Phase 1 study in adolescents with ADHD and genetic disruptions impacting~     genes in the metabotropic glutamate receptor (mGluR) network. The objectives of the study are~     to evaluate the safety, tolerability, and pharmacokinetics following single-dose, oral~     administration of NFC-1 and to evaluate safety and tolerability and to obtain evidence for~     the effect of NFC-1 on ADHD severity and global functioning during and following four weeks~     of continuous treatment. Exploratory analyses will be performed to assess effect size of~     specific mGluR-network genes on ADHD based on responsiveness of patients to NFC-1. This study~     will be conducted at a single clinical site, the Jefferson University Hospital PKU~     (Philadelphia, PA).~   "
97822|NCT02286804|"~     Up to 30 enrolled subjects will be treated. Enrolled subjects will receive Ultherapy®~     treatments along each length of the spider vein. Follow-up visits will occur at 30 and 60~     days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment,~     and at each follow-up visit.~   "
97823|NCT02286791|"~     The objective of this study is to determine whether regular Mindful Awareness Program (MAP)~     may reverse cognitive impairment and/or prevent further cognitive decline among older adults.~     60 elderly with mild cognitive impairment (MCI) were randomized to participate in either the~     MAP or the Health Education Program (HEP). Sessions will be conducted weekly for 12 weeks,~     and monthly for 6 months. Participants would be assessed at 3 time-points: at the start, at~     3-months and at 9-months.~      It was hypothesized that as compared to HEP participants, MAP participants will (1) have~     improved functional connectivity, (2) have a decreased risk in cognitive decline and (3)~     report higher psychological well-being.~   "
97824|NCT02286778|"~     The purpose of this study is to confirm the findings of an early study and expand our~     knowledge of treating Malignant Carcinoma in the Breast Tissue Using an ATP~     (Adenosine-5'-Triphosphate) Inhibitor.~   "
97825|NCT02286765|"~     Up to 20 enrolled subjects will be treated. Subjects will receive two Ulthera® treatments on~     the axillas provided 30 days apart. Follow-up visits will occur at 7, 30, 90 and 180 days~     following the last treatment.~      Protocol amendment: The study was expanded to enroll an additional 20 subjects into Group A.~   "
97826|NCT02286752|"~     Postoperative nausea and vomiting is one of most common complications after general~     anesthesia. Female sex, history of postoperative nausea and vomiting, motion sickness, non~     smoker status, opioid administration are known as risk factors for developing postoperative~     nausea and vomiting.~      It has been suggest that antagonism of residual neuromuscular block with a mixture of~     neostigmine and atropine at the end of the surgery increases the risk of postoperative nausea~     and vomiting.~      Sugammadex is a very safe drug with almost no serious adverse effects. The known adverse~     effects include slight coughing, movement, an altered taste sensation in the mouth, transient~     prolongation of the QT interval, hypersensitivity, and a short term prolongation of the~     activated partial thromboplastin time.~      The aim of this study was to compare the sugammadex versus neostigmine plus atropine for~     reversal of rocuronium induced neuromuscular blockade in terms of incidence of postoperative~     nausea and vomiting.~   "
97827|NCT02286739|"~     The objectives of the study are twofold: 1) Evaluate how intra-operative sensing may assist~     the surgeon with tibiofemoral rotational alignment by testing the precision and variability~     of setting tray rotation to the mid-third of the tibial tubercle. 2) Understand if patients~     with a combined axial rotation couple at the tibiofemoral joint and quantitative~     intercompartmental balance, achieved with the use of VERASENSE, exhibit less post-operative~     knee pain and improved clinical outcomes. Radiographic outcomes will also be assessed to~     measure post-operative alignment and to evaluate the prevalence and location of radiolucency~     and/or osteolysis.~   "
97828|NCT02286726|"~     The goal of this clinical research study is to compare different dose levels of CPX-351. The~     safety and efficacy of the drug will be studied in all dose levels.~   "
97829|NCT02286713|"~     Educational research study where goal is to test educational materials that help people make~     informed decisions about lung cancer screening.~   "
97830|NCT02286700|"~     The purpose of this study is to compare the effects of an amino acid moisturizing cream and~     desonide cream in reducing skin symptoms associated with AD/eczema in subjects with mild to~     moderate atopic dermatitis/eczema.~   "
97831|NCT02286687|"~     The goal of this clinical research study is to learn if talazoparib can help to control~     advanced cancer in patients who have a specific type of alteration (a type of genetic~     change). The safety of this drug will also be studied.~      This is an investigational study. Talazoparib is not FDA-approved or commercially available.~     It is currently being used for research purposes only. The study doctor can explain how the~     study drug is designed to work.~      Up to 150 participants will be enrolled in this study. All will take part at MD Anderson.~   "
97832|NCT02286674|"~     Anxiety in children undergoing surgery is a central concern to both parents and healthcare~     workers, including nurses, surgeons, and anesthesiologists. It has been ranked by~     anesthesiologists as one of the top five important low-morbidity anesthesia outcomes (1).~     This study would determine whether such devices would decrease anxiety in children prior to~     induction of anesthesia for outpatient surgery. Two hundred children ages 2-12 will be~     enrolled.~   "
97833|NCT02286661|"~     Distal radius fracture (DRF) is among the most common fractures of the long bones, which~     comprise one sixth of all fractures. Due to its high prevalence, effect on patients' everyday~     life, and cost on national health resources, its proper management is very important. The~     investigators performed this prospective randomized clinical trial on 100 patients with DRFs.~     50 patients were treated in each group either by short or long arm cast. Patients were~     visited during the 6th and 18th weeks after the reduction regarding loss of reduction and~     possible complications.~   "
97834|NCT02286648|"~     The purpose of this study is to evaluate the clinical and radiographic success rate of~     Miniature pulpotomy with Mineral Trioxide Aggregate (MTA) in primary molars.~   "
97835|NCT02286635|"~     The primary objective of the study is to determine the potential effects of multiple doses of~     rifampin and clarithromycin on the single dose pharmacokinetics (PK) of the deflazacort~     active metabolite (21 desacetyl-DFZ) in healthy adult subjects.~   "
97836|NCT02286622|"~     This is a non-randomized, open-label, single-dose study to compare the PK of 21 desacetyl-DFZ~     and, if data permits, deflazacort in 8 subjects with ESRD to that of 8 healthy matched~     control subjects (age, body mass index [BMI], and gender).~   "
97837|NCT02286609|"~     This is a non-randomized, open-label, single-dose study to compare the PK of 21-desacetyl-DFZ~     and, if data permits, deflazacort in 8 subjects with moderate hepatic impairment (based on~     the Child Pugh classification, Grade B) to that of 8 healthy matched control subjects (age,~     body mass index [BMI], and gender).~   "
97838|NCT02286596|"~     Homozygous familial hypercholesterolemia (HoFH) is characterized by a six- to eight-fold~     raise in plasma LDL-cholesterol (LDL-C) concentrations and atherosclerotic coronary artery~     disease usually occur before the age of 20 if untreated. Lipid apheresis (LA) has been proved~     to be a reliable method to decrease LDL-C concentrations and therefore decrease~     cardiovascular disease risk in HoFH. The objective of this crossover study was to compare~     efficacy of LA performed with heparin-induced extracorporeal LDL precipitation to dextran~     sulfate adsorption on the reduction of lipids, inflammatory markers, adhesion molecules and~     LDL particles size in a cohort of HoFH subjects.~   "
97839|NCT02286583|"~     Medical Radiometer depends on detecting the microwaves that radiates from deep structure hot~     objects in the body. When it comes to the breast, causes of deep structure hot spots are~     numerous, it can be inflammatory, hormonal or neoplastic. Therefore, the primary objective of~     this study is to test the sensitivity of the Medical Radiometer in detecting the hot spots in~     the breast.~   "
97840|NCT02286570|"~     Trauma victims had to be intubated at the scene of area in different conditions. Face-to-face~     intubation in an entrapped patient is one of these situations. The investigators want to~     compare the efficacy of Glidescope, Airtraq and Fastrach in simulating face-ro-face~     intubation in adult patients aged between 18-60 years.~   "
97841|NCT02286557|"~     Up to 95% of individuals with Multiple Sclerosis report experiencing cognitive fatigue,~     characterized by a lack of energy, feelings of exhaustion, an the perception that one is~     unable to partake in daily activities. The goal of this project is to test whether~     methylphenidate (MP), a well-known psychostimulant, can effective treat fatigue experienced~     by individuals with MS.~      The current study will test the effect of MP on MS fatigue through a clinical trial. Every~     participant in the study will be exposed to both the drug and the placebo for a period of~     time. Both the investigators and participants will be unaware whether participants are~     receiving the drug or the placebo.~      Upon successful completion of the study, physicians will be able to evaluate the potential~     prescription of MP to treat fatigue in persons with MS based on solid research evidence.~     Importantly, MP is already an FDA approved widely used medication in multiple clinical~     populations.~   "
97842|NCT02286544|"~     Oxygen treatment is widely used in acutely ill patients. In particular, oxygen treatment is~     routinely used in acute coronary syndrome (ACS) patients with suspected acute myocardial~     infarction and variably recommended in ACS-guidelines, despite very limited data supporting a~     beneficial effect.~      Immediate re-opening of the acutely occluded infarct-related bloodvessel via primary~     percutaneous coronary intervention (PCI) is the treatment of choice to limit ischemic injury~     in the setting of ST-elevation ACS (STE-ACS). However, the sudden re-initiation of blood flow~     achieved with primary PCI can give rise to further damage, so-called reperfusion injury.~     Ischemia and reperfusion associated myocardial injury (IR-injury) involves a wide range of~     pathological processes. Vascular leakage, activation of cell death programs, transcriptional~     reprogramming, no reflow phenomenon and innate and adaptive immune activation all contribute~     to tissue damage, thereby determining the infarct size. The effect of oxygen treatment on~     these pathological processes, on the extent of IR-injury and the final infarct size in~     STE-ACS patients has not previously been studied.~      ACS is characterized by a systemic inflammation with typical elevations of soluble~     inflammatory markers as well as changes in white blood cells. The inflammatory reaction might~     be considered helpful in restoring myocardial tissue structure and function, but on the other~     hand it might worsen IR-injury by activating various pathological processes. In human~     experimental studies, Salmonella typhi vaccine has been used to create a standardized model~     of systemic inflammation and when administered to healthy volunteers the vaccination has not~     been associated with any adverse events.~      In an ongoing register randomized multicentre clinical trial, the DETO2X (Determination of~     role of oxygen in suspected acute myocardial infarction) study, the effect of oxygen on~     morbidity and mortality in ACS patients is being investigated. In a substudy of the~     DETO2X-trial, the investigators have planned to evaluate the effect of oxygen treatment on~     IR-injury in STE-ACS as assessed by biomarkers reflecting various aspects of the pathological~     processes involved.~      The presented study is an experimental pilot study performed in healthy volunteers with a~     Salmonella typhi vaccine-induced inflammation with the purpose of studying effects of oxygen~     treatment on biological systems involved in the pathogenesis of IR- injury.~   "
97843|NCT02286531|"~     Determine the overall discriminatory ability of FET PET in the diagnosis of glioma grade II~     (referring to the current diagnostic gold standard represented by the histopathology exam of~     a tumor sample).~   "
97844|NCT02286518|"~     The purpose of this study is to evaluate the safety and tolerability of TAK-114 following~     single and multiple ascending oral doses in healthy Japanese male participants.~   "
97845|NCT02286505|"~     Early dementia diagnosis improves patient and carer experience, links them to appropriate~     care and support and enables timely symptomatic treatment. The guidelines of the UK National~     Institute for Health and Care Excellence recommend brain Magnetic resonance imaging (MRI) to~     assist with the diagnosis in suspected dementia. Recently, computerised analysis of MRI~     scans, also known as automated brain morphometry, has shown potential to detect the brain~     changes characteristic of early dementia, and may therefore be a useful addition to the~     standard reporting performed by a neuroradiologist. The present pilot study will assess~     whether adding brain morphometric analysis to the usual diagnostic pathway improve diagnosis~     in clinical practice as an addition to the existing diagnostic pathway in a memory clinic~     setting. The main purpose of the study is to compare measures of the clinicians diagnostic~     confidence in patients with and without brain morphometry.~   "
97846|NCT02286492|"~     The objective of the program is to provide access to TAS-102 to patients with metastatic~     colorectal cancer who are refractory to or failing standard chemotherapy, are new to therapy~     with TAS-102 and in whom therapy with TAS-102 is clinically indicated.~   "
97847|NCT02286479|"~     Skin abscesses are among the most common soft tissue infections cause emergency room visits~     frequently. Management of abscess drainage and prevent further complications are important~     entities for emergency physicians. Historically primary incision and drainage (I&D) technique~     has found very effective method of abscess drainage, however a novel technique loop drainage~     holds promising. The purpose of our study is comparison efficacy of I&D and loop drainage~     techniques in patients with cutaneous abscess.~   "
97848|NCT02286466|"~     The proposed study seeks to implement a randomized controlled trial to evaluate the~     effectiveness and generalizability of an efficacious cognitive-behavioral therapy (CBT)~     intervention for use as a self-administered mobile application (mobile app) to treat anxiety~     in patients with metastatic cancer.~   "
97849|NCT02286453|"~     Efficacy and adverse effects of Benjakul recipe in Treating Primary Osteoarthritis of Knee~     Compared with Diclofenac. This study was designed as double blind, randomized controlled~     trial. Approval from the ethical committee of Human Research Ethics Committee of Thammasat~     University (No: 1 Faculty of Medicine)~   "
97850|NCT02286440|"~     The overall goal of this investigator-initiated trial is to evaluate the impact of platform~     algorithm products designed to rapidly identify pharmacokinetic (PK) and/or pharmacodynamic~     (PD) genomic variation on treatment outcome of depression in adolescents. This new technology~     may have the potential to optimize treatment selection by improving response, minimizing~     unfavorable adverse events / side effects and increasing treatment adherence~   "
97872|NCT02286154|"~     The primary objectives of this prospective study of hydroxyurea for children with sickle cell~     anemia are 1) Develop and prospectively evaluate a population~     pharmacokinetic/pharmacodynamics model to predict the maximum tolerated dose (MTD); 2)~     Identify urine biomarkers of hydroxyurea adherence using a novel metabolomics approach; 3)~     Identify pharmacogenomics modifiers of hydroxyurea MTD; and 4) Longitudinal monitoring of the~     effect of hydroxyurea upon organ function and quality of life.~   "
97851|NCT02286427|"~     Skin wounds of Recessive Epidermolysis Bullosa Dystrophica (REBD) involve pain,~     superinfection, protein-losing, inflammation, and joint contractures are the bed of squamous~     cell carcinoma. There is no precise data on the kinetics of healing post-bullous erosions but~     clinical experience suggests that most epidermise in less than a month. Some, however, for~     unknown reasons, persist for several months. These chronic ulcers (UC), arbitrarily defined~     for this study as lasting more than three months are a source of major discomfort and could~     play a decisive role in the morbidity and mortality of the disease.~      The aim of this study is to evaluate the efficacy of the amniotic membrane on the healing of~     chronic ulcers REBD on the percentage ulcerated surface re-epithelialised at 12 weeks (M3)~     from the start of treatment.~   "
97852|NCT02286414|"~     The aim of the study is to compare, in real life, the risk benefit (including both major~     bleeding and thrombotic events (TE) and death from any cause) associated with direct oral~     anticoagulants (DOA) and with anti vitamin K (VKA) in older adults (≥ 80 years) suffering~     from non valvular atrial fibrillation and living in community or nursing home settings.~      An observational multicenter prospective inception cohort will be conducted within the~     PRESAGE-Network, an ongoing active network on drug safety in older adults in France involving~     a sample of general practitioners (GPs) and pharmacists, for an active surveillance of drug~     safety in older adults. GPs and pharmacists will prospectively include all octo+ patients~     they care for, newly treated with an oral anticoagulant (VKA or DOA) for nv AF and will~     follow them during 2 years at least.~   "
97853|NCT02286401|"~     The purpose of this pilot study proposal is to test the ability of Transluminal Flow Encoding~     (TAFE) to evaluate vessel specific ischemia in patients with a clinical indication for~     invasive coronary angiography (ICA) with fractional flow reserve (FFR) measurements for~     suspected coronary disease.~   "
97854|NCT02286388|"~     This clinical trial is a national multicenter randomized controlled trial performed in~     parallel groups aiming to validate a treatment that preserves pulp vitality of mature~     permanent posterior teeth through partial removal of carious tissue and restoring tooth~     structure using a simple filling in one session, thus delaying premature tooth aging.~      Two successive randomizations will be performed (allocation ratio 1:1); firstly for the type~     of excavation carried out (partial vs. complete caries removal) and secondly for the nature~     of the adhesive used (antibacterial adhesive vs. non-antibacterial adhesive). The second~     randomization will not be carried out for teeth requiring endodontic treatment after the~     first randomization.~      The study's primary objective will be to compare, at 1 year of follow-up, the efficacy~     (binary success criteria) of partial caries removal versus complete caries removal in~     occlusal or proximal deep lesions of mature permanent posterior teeth (bicuspids and molars~     except third molars). Secondary objectives will include the comparison, at 1 year of~     follow-up, of the efficacy (binary success criteria) of an antibacterial two-step self-etch~     adhesive versus a traditional non-antibacterial two-step self-etch adhesive. Another~     secondary objective will be to compare, at two and three years of follow-up, the efficacy of~     partial versus complete caries removal.~      The primary outcome is the success of the caries removal protocol at one year, measured~     according to 5 FDI criteria, while the secondary outcome is the contribution of the~     functional and biological dimensions of the 5 FDI criteria items to determining success or~     failure of the treatment. The outcome of success will be the same for all objectives, primary~     and secondary.~   "
97855|NCT02286375|"~     This paper aims to describe the research protocol that will be used to determine the~     effectiveness of a health-social partnership intervention programme among community-dwelling~     older adults~   "
97856|NCT02286362|"~     This non-interventional prospective study will assess the safety of Herceptin SC~     (subcutaneous administration) as used in routine clinical practice. Patients with~     HER2-positive early breast cancer, naive and non-naive of HER2+ treatment who are to be~     treated in the neoadjuvant and adjuvant setting and scheduled to initiate a treatment with~     Herceptin SC in routine clinical practice use are eligible to participate. The total study~     duration is anticipated to be 38 months.~   "
97857|NCT02286349|"~     This study aims to evaluate the effect of noninvasive brain stimulation in adults with ADHD~     symptomatology compared them with healthy adults. For this, volunteers will allocate into two~     groups (experimental and control), will pass through session two types of transcranial~     stimulation: Repetitive Transcranial MagneticsStimulation (rTMS) and transcranial direct~     current stimulation (tDCS); considering two session types (real and sham). Attentional~     assessment will be carried out through specific neurocognitive tests applied before and after~     each session of stimulation~   "
97858|NCT02286336|"~     The aim of this study is to determine the minimum effective concentration of local anesthetic~     (ropivacaine 40mL) required to produce an effective double-injection USG-SCB for surgical~     anesthesia in 90% of patients (MEC90) in young group (18-40 years) and in middle aged group~     (40-65 years) of patients scheduled for elective surgery of one upper limb distal to the~     shoulder.~   "
97859|NCT02286323|"~     We hypothesized that the BONFILS is beneficial for intubation of manikins while performing~     CPR. In the current study we compared the performance of the BONFILS and the Macintosh~     laryngoscopes with respect to their effectiveness and time to successful ETI during chest~     compression (CC) using an adult manikin.~   "
97860|NCT02286310|"~     The aim of this study is to investigate the effect of exercise program on 3-dimensional~     scapular kinematics, disability and pain on shoulder impingement with scapular dyskinesia.~   "
97861|NCT02286297|"~     Endotracheal intubation (ETI) is perceived as the optimal method of providing and maintaining~     a clear and secure airway. The 2010 European Resuscitation Council (ERC) guidelines~     emphasized the importance of minimal interruption during cardiopulmonary resuscitation (CPR).~     These guidelines also suggest that skilled operators should be able to secure the airway~     without interrupting chest compression. The aim of the study was to compare time and success~     rates of different available video laryngoscopes and the Miller laryngoscope for emergency~     intubation during simulated pediatric CPR.~   "
97955|NCT02285075|"~     The current study aimed to explore the pharmacokinetics of temocillin in patients treated~     with haemodialysis and to demonstrated whether or not the pharmacodynamics target of a time~     above a MIC of 16 mg/L of more than 40 and 60 % of the dosing interval could be obtained with~     a dosing schedule of 1 gram/24 hours, 2 gram/48 hours and 3 gram/72 hours, all of these doses~     given after haemodialysis sessions only.~   "
97862|NCT02286284|"~     Introduction Preeclampsia is a multifactorial disease that is responsible of important~     adverse maternal and perinatal outcomes. Recently, it has been suggested that soluble~     fms-like tyrosine kinase 1, s-Flt1, induces preeclampsia-like phenotype in experimental~     models and circulates at elevated levels in human preeclampsia.~      The aim of our study is to see whether removal of s-Flt1 may improve perinatal death in women~     with very early severe preeclampsia at less than 26 weeks' gestation Patients and methods~     Phase II trial. Women with singleton pregnancy having severe preeclampsia at 23-256/7 weeks'~     gestation. Women under 18 years, with multiples, or severe fetal growth restriction (less~     than 5th centile), or abnormal fetal heart rate, or maternal complications (abruption,~     eclampsia, HELLP syndrome, pulmonary edema, DIC, liver hematoma) are excluded from the study.~     After blood pressure and maternal stabilization, women are approached for information and if~     they agree, to sign the trial consent.~      Women have twice weekly extracorporeal removal of s-Flt1 until 34 weeks' gestation.~      Primary endpoint or success of the procedure: baby alive or alive at 6 months if hospitalized~     Statistical procedure Simon minimax plan; P0: 60%, P1, 90%, alpha error: 5%, beta power; 90%.~     First step: number 8 patients. If success equal or less than 5, the study is stopped.~      Second step: if success of 6 or more, the study is continued for 9 more patients.~      Overall, a maximum of 17 patients will be included. The final success of extracorporeal~     removal of s-Flt1 will be considered if 14 or more babies will be alive or alive at 6 months~     if hospitalized.~   "
97863|NCT02286271|"~     Official statistics report around 1000 deaths due to epilepsy in the UK each year (Hanna et~     al 2002). Most of these deaths are un-witnessed and in many cases are believed to have been~     avoidable with timely assistance (Langan et al 2000). A major problem is detecting nocturnal~     seizures to allow body re-positioning, to maintain an open airway and to administer rescue~     medication. There are several seizure alarms commercially available but are often unreliable~     with many false alarms. The aim of this study is to investigate a novel seizure detection~     system with a unique algorithm.~   "
97864|NCT02286258|"~     The purpose of this study is to validate in comparison to a reference method (inuline) two~     novel non-radioactive biomarkers for glomerular filtration rate (GFR) measurement in~     chronic-kidney disease (CKD) patients and in healthy volunteers: Calcium-EDTA and Gd-DOTA.~   "
97865|NCT02286245|"~     Telephone medical advice in general practice is expanding. The Cochrane Database concludes in~     2008 that there is not enough data about its use regarding out-of-hours general practitioners~     workload, emergency department visits, cost, safety and patient satisfaction. The aim of this~     study is to assess the effectiveness of telephone medical advice given by a general~     practitioner in a call centre for patient presenting isolated fever or gastroenteritis~     symptoms.~   "
97866|NCT02286232|"~     Chronic low back pain is a common condition that can negatively impact quality of life and~     that lacks highly effective treatment options. The YMCA developed different iterations of a~     stretching exercise program as a community based treatment for low back pain from 1974-2004.~     Though anecdotally successful, the YMCA stretching exercise program(s) was not scientifically~     evaluated for efficacy and became obsolete. The purpose of the study is to test the efficacy~     of a previously popular YMCA stretching exercise program(s) for back pain. The stretching~     exercise program that will be studied is a collection of all the resources available for the~     YMCA stretching exercise program(s). The most recent criteria from a National Institutes of~     Health sponsored Task Force to study chronic low back pain were applied to this study.~   "
97867|NCT02286219|"~     To evaluate the safety, tolerability, dose limiting toxicity (DLT), and maximum tolerated~     dose (MTD), of FS102(BMS-986186) when administered intravenously (IV) to subjects with~     relapsed or refractory solid tumors that overexpress HER2 and who have no standard treatment~     options.~   "
97868|NCT02286206|"~     The objectives of this 15-day study are:~        1. To compare steady-state trough plasma concentrations of clozapine and its metabolite~          norclozapine when given once daily and twice daily (at the same total daily dose)~        2. To determine if frequency of clozapine administration has an effect on:~             1. Symptoms of schizophrenia~             2. Adverse effects of clozapine~             3. Fasting blood glucose, lipids, creatinine, and urea~             4. Weight and waist circumference~   "
97869|NCT02286193|"~     This project will engage patients and health care teams to develop, implement, and rigorously~     evaluate a new lay health worker role (Community Resource Specialist, CRS) for primary care~     teams. The CRS will link patients and healthcare clinics with community resources.~   "
97870|NCT02286180|"~     Background and objectives:~      Recently the news of intern doctors' death due to overloaded work or committing suicide has~     made the authorities concerned put emphasis on the mental health care of medical staffs and~     related policies of psychological interventions. The prefrontal lobe plays an important role~     in the working memory, executive function and problem-solving abilities of the brain.~     Currently, no neuroimaging studies investigating the impact of job stress on the prefrontal~     love functions in intern doctors. Functional near-infrared spectroscopy (fNIRS) measures the~     cortical functions of the frontotemporal regions and has been widely used as a biomarker to~     aid in differential diagnoses in major psychiatric illnesses in Japan. The present study will~     investigate impact of the job stress on brain cortical activity during a verbal fluency test~     (VFT) by using fNIRS.~      Materials and methods:~      A total of 100 participants will be recruited. Clinical measurements of mood status by Beck's~     Depression Inventory and Beck's Anxiety Inventory, as well as job stress by Chinese Version~     of the Job Content Questionnaire and the Chinese version of Copenhagen Burnout Inventory will~     be arranged. The relationship between clinical measurements and cortical activity during a~     VFT will be analyzed by Pearson's correlation. Multiple regression analysis will be applied~     to investigate the independent contributions of mood status and job stress.~      Expected results and contributions of the study:~      Job stress, depression, and anxiety are significantly negatively correlated with cortical~     activity of prefrontal regions. The importance of mental health of medical staffs under high~     job stress should be stressed.~   "
97871|NCT02286167|"~     The primary goal of this study is to assess the feasibility and biologic activity of a~     modified Atkins-based diet combined with short-term intermittent fasting, a GLioma~     Atkins-based Diet (GLAD), in patients with central nervous system GBM.~   "
97873|NCT02286141|"~     Back pain is one of the most common, controversial and costly problems in healthcare. Despite~     numerous studies, care for back pain has deteriorated over time and become much more~     expensive. The risk stratification approach developed in England and found effective in~     National Health Service general practices in the UK provides a very promising strategy for~     improving care for back pain in the U.S.~      The MATCH trial will use a cluster randomization design involving 6 primary care clinics at~     Group Health. Of these 6 clinics, 3 will be randomized to receive Group Health's standard~     training in the use of Group Health back pain guidelines and 3 clinics will receive this~     standard training plus supplemental training. Primary care clinicians and physical therapists~     in the intervention group will receive training in the use of the STarTBack risk~     stratification strategy for matching the most appropriate evidence-based treatments to the~     needs of patients in each risk level. We will evaluate the effect of this supplemental~     training on patient outcomes, clinician and physical therapist knowledge and comfort treating~     patients with back pain, and utilization of services for back pain.~   "
97874|NCT02286128|"~     This study determines whether NF-кB dependent proinflammatory state found in type 2 diabetes~     yield to a higher RAGE activation in the mesenchymal stem cell, as well as the effects of the~     proinflammation on osteoblast differentiation impairment and cellular apoptosis in type 2~     diabetic patients. This study will compare non-diabetic control subjects and type 2 diabetic~     patients with metformin monotherapy failure in the aspect of 1) serum markers for NF-кB~     dependent proinflammatory state and its intracellular signals, 2) osteogenic differentiation~     and apoptosis of the mesenchymal stem cells, and 3) serum AGE, RAGE and cellular RAGE~     activation.~   "
97875|NCT02286115|"~     The goal of this study is to test the efficacy, feasibility, and acceptability of providing~     an experiential assessment interview that targets health, and emotional and stressful~     experiences in a tertiary care setting specializing in women's urology.~   "
97876|NCT02286102|"~     The examination of the ability of the OrthoPAT® blood collection device to decrease the~     transfusion rate and volume of adults undergoing posterior spine surgery for deformity~     correction of 6 levels or more.~   "
97877|NCT02286089|"~     The main objective of the study is evaluation of the safety and tolerability of OpRegen -~     human embryonic stem cell-derived retinal pigment epithelial (RPE)cells. The study will also~     include initial exploration of the ability of transplanted OpRegen cells to engraft, survive,~     and moderate disease progression.~   "
97878|NCT02286076|"~     To compare changes in follicular ovarian reserve in women before and six months after~     laparoscopic operation: endometrioma stripping surgery. Also, to compare follicular ovarian~     reserve in women with endometrioma(s) with follicular ovarian reserve of healthy infertile~     women of the same age group.~   "
97879|NCT02286063|"~     The main aim of this project is to establish whether ambulatory oxygen in patients with~     fibrotic ILD whose oxygen saturation falls ≤ 88% on a 6MWT, leads to a significant~     improvement in health status. The core of the project will be a four week randomised,~     crossover controlled trial of ambulatory oxygen used during daily activities. The optimal~     Oxygen flow rate is determined by titration at screening visit and administered during~     activity for a two-week period, compared to two weeks off oxygen.~   "
97880|NCT02286050|"~     The purpose of this study is to evaluate the effect of a nursing program in patients with~     cystic fibrosis.~   "
97881|NCT02286037|"~     Assessments of mechanical skin sensitivity include psychophysical responses to stimulation~     with calibrated polyamide monofilaments.~      One of the applications of polyamide monofilaments are the assessments of magnitude of~     secondary hyperalgesia areas (SHAs), i.e. areas in normal skin near an injury with increased~     mechanical sensitivity.~      The objective of the study is to investigate the hypothesis, based on previous studies, that~     a light tactile stimulus delineates a larger SHA than stimulation with a more rigid~     monofilament.~      Twenty-three healthy participants were included in this randomized, two-observer, test-retest~     study.~      A highly significant positive correlation between the bending force of the polyamide~     filaments and the magnitude of SHA was demonstrated. The weighted-pin instrument showed~     significantly and consistently larger areas than the polyamide monofilaments.~      The hypothesis was rejected: a light tactile stimulus did not delineate a larger secondary~     hyperalgesia area than stimulation with a more rigid monofilament. The weighted-pin~     instrument seems an alternative to the conventional polyamide monofilaments.~   "
97882|NCT02286024|"~     Depression is a debilitating illness with a risk of developing a treatment resistant form.~     Currently, diagnosis is purely clinical with little features available to identify~     potentially adverse developments. Clinical features such as early onset age, prolonged~     episodes, anxiety, somatic symptoms and apathy are all arguments raising fears the onset of~     resistance to conventional treatments. According to neuroimaging knowledge about the~     pathophysiological mechanisms, involving front-limbic functional networks supporting the~     functions of emotional regulation and reward system, recent work has focused on the~     identification of neuroimaging biomarkers predicting therapeutic response. Among the regions~     of interest identified, the anterior cingulate cortex, amygdala, hippocampus, and regions~     participating in the Default Mode Network Training (Medial prefrontal cortex, posterior~     cingulate cortex, inferior parietal lobe) are most frequently areas associated with the~     prediction of therapeutic response. Limitations most reported in these studies are the~     heterogeneity of experimental paradigms (resting state, cognitive or emotional functional~     tasks), imaging (PET scan, MRI) the heterogeneity of clinical resistance criteria forms~     studied, different techniques (as that we consider remission (threshold score) or response~     (50% decrease from baseline score), and the sample size. Knowing that MRI into daily clinical~     practice in the SHU of Adult Psychiatry, as the balance sheet of the disease, monitoring its~     evolution, as in assumption rTMS (repetitive Transcranial Magnetic Stimulation) (pretreatment~     assessment and neuro), the identification of neuroimaging biomarkers in a population of~     patients with clinical criteria of Mood Depressive Episode, with an acquisition of identical~     and reproducible image daily routine methodology appears to be a reliable way to correct the~     heterogeneity of conventionally published studies on the topic. This study aim to identify,~     in routine care, predictive clinical and neuroimaging markers of poor outcome in major~     depressive disorder.~   "
97883|NCT02286011|"~     The purpose of this study is to evaluate the safety of Intramuscular Infusion of Autologous~     Bone Marrow Stem Cells in Patients With Amyotrophic Lateral Sclerosis by a prospective,~     single-center, randomized, parallel, double-blind, placebo-controlled phase I clinical trial.~   "
97884|NCT02285998|"~     The goal of this study is to establish that Flublok Quadrivalent is non-inferior to fully~     licensed (traditional approval status) quadrivalent inactivated influenza vaccine (IIV4) in~     protecting against laboratory-confirmed clinical influenza disease in the ≥50 year age~     population.~   "
97885|NCT02285985|"~     In this research study, Investigators will be comparing the effects of a medication~     Saxagliptin versus placebo (a similar looking pill that contains no medication) on~     inflammation in the body.~      Research Hypothesis DPP-4 inhibition by saxagliptin (ONGLYZA™) reduces adipose tissue~     inflammation in obese individuals and this is characterized by decreases in a) reactive~     oxygen species (ROS) production, b) toll-like receptors (TLR) and NF-kappa B pathway~     activation, c) expression of pro-inflammatory genes, d) macrophage infiltration, and e)~     secretion of pro-inflammatory factors.~   "
97886|NCT02285972|"~     Propofol remains the most common drug for induction of general anaesthesia, although it~     causes considerable pain or discomfort on injection. Anesthesia providers have attempted a~     large number of remedies to prevent this pain on injection. Previously explored ideas include~     injecting propofol into larger veins, warming of the hand with hot packs, and intravenous~     pretreatment with numerous other medications. No studies to date have looked at the~     dexketoprofen and tenoxicam for the pretreatment of pain on injection caused by propofol. The~     investigators propose studying the use of dexketoprofen and tenoxicam for pretreatment of~     propofol related pain on injection.~   "
97887|NCT02285959|"~     The high-grade malignant brain tumor glioblastoma multiforme (GBM) comprise the majority of~     all primary brain tumors in adults. This group of tumors also exhibits the most aggressive~     behavior, resulting in median overall survival durations of only 9-12 months for GBM. Initial~     therapy consists of surgical resection, external beam radiation or both. Currently, all~     patients experience a recurrence after this first-line therapy, so improvements in both~     first-line and salvage therapy are critical to enhancing quality-of-life and prolonging~     survival. Superselective Intraarterial Cerebral Infusion (SIACI) is a technique that can~     effectively increase the concentration of drug delivered to the brain while sparing the body~     of systemic side effects. This technique threads a tiny catheter through the patient's~     femoral artery in the leg, up through the body and neck and into the brain. Once the catheter~     reaches the brain, chemotherapy is released to the blood vessels that feed the tumor.~   "
97888|NCT02285946|"~     During mechanical ventilation, the alveolar recruitment maneuver (ARM) is to apply a positive~     end-expiratory pressure (PEEP) (generally 30 cm H2O) for a period of at least 30 seconds. The~     realization of MRA is one of three main elements of mechanical ventilation called~     protective. This ventilatory strategy, originally described for the ventilation of acute~     respiratory distress syndrome (ARDS), and pulmonary and during abdominal surgery is based on~     a decrease tidal volumes, optimization of PEEP and the realization of MRA. Protective~     ventilation limit the occurrence of atelectasis, the surdistentions and, ultimately,~     significantly decreases postoperative complications.~      The MRA is currently recommended in the major surgery. Most spine surgery (eg~     transpedicular fixation) used in this definition, the MRA are indicated and now commonly~     used. This type of surgery requires further positioning the patient in the prone position~     (DV). The DV modifies the compliance of the chest respiratory characteristics and changes~     (increase in insufflation pressure) and hemodynamic (decreased venous return) of the patient.~      Respiratory and haemodynamic effects of MRA made VIS at major spine surgery are not known.~     The aim of this observational study, non-interventional, is to compare the hemodynamic and~     respiratory effects of MRA performed in DV to those of MRA performed in the prone position~     (DD).~      The investigators hypothesis is that the respiratory and hemodynamic consequences of MRA~     performed in DV is different from those conducted in DD. A better understanding of~     hemodynamic and respiratory characteristics of MRA performed in DV would provide a more~     tailored to this type of surgery respiratory optimization strategy and reduce respiratory~     complications of this surgery.~   "
97889|NCT02285933|"~     The purpose of this study is to determine if the addition of 10 to 12 sessions of sitting~     balance exercises using virtual reality training will provide additional gains in balance~     ability and function over standard inpatient rehabilitation in stroke patients.~   "
97890|NCT02285920|"~     The SPin-D Trial is a phase II randomized, double-blind, placebo-controlled, multi-center~     study of spironolactone (SPL) for patients with hemodialysis-dependent end-stage renal~     disease.~   "
97891|NCT02285907|"~     To determine whether the consumption of a beef-rich lunch improves appetite control, satiety,~     and energy intake regulation while reducing food reward and food cravings compared to the~     consumption of a soy-rich lunch when matched for macronutrients and fiber content or when~     match for serving size. The mechanisms of action surrounding the differential responses of~     beef versus soy proteins were also explored.~   "
97892|NCT02285894|"~     This study evaluates whether sustaining inspiratory pressure for 10 seconds at a time can~     open collapsed lung areas in non-dependant regions of the lung in mechanically ventilated~     patients.~   "
97893|NCT02285881|"~     Background: Less than 20% of type 2 diabetes mellitus (T2DM) patients in different healthcare~     settings achieve all treatment goals to prevent cardiometabolic disease. A more personalised~     approach with shared decision making should increase that percentage. Because the~     ADDITION-Europe study demonstrated two (almost) equally effective treatments but with~     slightly different intensities, it may be a good starting point to discuss with the patients~     their diabetes treatment, taking into account both the intensity of treatment, clinical~     factors and patients' preferences. The aim of the study was to evaluate whether such an~     approach increases the proportion of treatment goals that T2DM patients achieve.~      Methods: In a cluster-randomised trial in 40 primary care practices that participated until~     2009 in the ADDITION Study, 150 T2DM patients 60 - 80 years, known with T2DM for 8-15 years,~     will be included. Practices are randomised a second time, i.e. intervention practices in the~     ADDITION study could be control practices in the current study and vice versa. For the GPs~     from the intervention group a 2-hour training in shared decision making (SDM) was developed~     as well as a decision support tool to use during the consultation. These GPs plan the first~     visit with the patients to decide on the intensity of the treatment, personalised targets and~     the priorities of treatment. The control group will continue with the treatment they were~     allocated to in the ADDITION study (treatment-as-before). Follow-up: 24 months. The primary~     outcome is the proportion of patients who achieve all three treatment goals (HbA1c, blood~     pressure, total cholesterol) at 24 months. Secondary outcomes are the proportion of patients~     who achieve five treatment goals (HbA1c, blood pressure, total cholesterol , body weight, not~     smoking), evaluation of the SDM process (SDM-Q9), satisfaction with the treatment (DTSQ),~     wellbeing and quality of life (W-BQ12, ADD QoL-19), health status (SF-36, EQ-5D) and coping~     (DCMQ). The proportions of achieved treatment goals will be compared between groups by~     estimating the relative risk of meeting the treatment targets. For the secondary outcomes~     mixed models will be used.~      Discussion: To achieve optimal diabetes care with a higher proportion of achieved~     individualised treatment goals, the SDM approach including a multi-faceted decision support~     tool might be useful. An intervention with such a support decision tool is designed.~   "
97956|NCT02285062|"~     To evaluate the efficacy and safety of lenalidomide, rituximab, cyclophosphamide,~     doxorubicin, vincristine, and prednisone (R2-CHOP) chemotherapy versus placebo, rituximab,~     cyclophosphamide, doxorubicin, vincristine, and prednisone (placebo-R-CHOP) chemotherapy in~     patients who have previously untreated ABC type DLBCL.~   "
97894|NCT02285868|"~     The investigators goal is to provide a mechanism that allows for a better understanding of~     patient outcomes following rehabilitation. This includes functional outcomes measured by~     standardized and validated tools from the published literature. It incorporates comorbidities~     and patient demographic characteristics. It includes measures of general health as well along~     with activities of daily living and behavioral health aspects. Measures of quality and~     satisfaction and use of Net Promoter Scores also are included. All of these components come~     together to form a remarkably comprehensive picture of patients and their associated~     outcomes. This is a unique milestone in rehabilitative care and will act to inform and direct~     evidence-based approaches and treatment guidelines.~      Data are collected via the investigators proprietary electronic medical record system and are~     synthetic to the clinical process—that is, the data are collected in real-time with patients~     and the scores are immediately provided to the treating therapist as well as archived for~     later Registry and scientific use. Subsequent reporting can be risk adjusted to any variable~     collected which yields robust insights as to idiopathic patient conditions. However, no PHI~     information will be available.~   "
97895|NCT02285855|"~     The goal of this clinical research study is to learn if giving metformin in combination with~     radiation therapy is more effective than radiation therapy alone. In this study, participants~     will receive either metformin or a placebo. A placebo is not a drug. It looks like the study~     drug but is not designed to treat any disease or illness. It is designed to be compared with~     a study drug to learn if the study drug has any real effect.~   "
97896|NCT02285842|"~     MicroPort Orthopedics (MPO) is conducting this PMCF study to evaluate the safety and efficacy~     of its THA and resurfacing components marketed in the EU. These types of studies are required~     by regulatory authorities for all THA and resurfacing devices that do not have medium to~     long-term clinical evidence available at the time of gaining approval to market in the EU.~     This study has been designed in accordance with MEDDEV 2.12/2 rev 2.~   "
97897|NCT02285829|"~     During lumbar spine fusion surgery intraoperative neurophysiological monitoring is in routine~     use for prevention of possible nerve injuries during placement of screw into pedicle. Pedicle~     screw stimulation test is performed to assess if screw placement is encroaching on the nerve~     roots. Relative distance between the pedicle screw and the neighbouring root can be estimated~     by the intensity of the current required to activate the root and appropriate muscle. A~     properly placed screw can be distinguished from those perforating the pedicle wall by its~     higher minimum level of electrical current needed to elicit a muscle response. The minimum~     level is deemed as threshold. This test is based on compound muscle action potential (CMAP)~     and use of neuromuscular blocking agents (NMBA) should be avoided because of possible cause~     of false negative results of screw stimulation test. Neuromuscular blocking agents, which are~     in routine use during anesthesia, will have effect on muscle action potential. When NMBA are~     used current stimulus will depolarize the same number of axons and the associated muscle~     response will be present but of lower amplitude because some percentage of motor fibers will~     be blocked by activity of NMBA. At this point, stronger stimulus is needed to recruit~     additional axons/muscle fibers , and hence, the measured threshold is elevated.~      Train of four (TOF) test is method used to determine level of neuromuscular blockade, by~     stimulation of peripheral nerve and following induced muscle contractions. Interpretation of~     muscle contractions may be by subjective (visual) or objective (quantitative) method.~     Quantitative TOF test may be used prior screw stimulation test by calculating T4/T1 ratio and~     obtaining quantitative value which shows level of neuromuscular blockade. Residual~     neuromuscular blockade may be present before screw stimulation test, and effect on accuracy~     of this test in this situation was not clearly investigated in recent studies.~      The purpose of this study would be to determine changes of screw stimulation thresholds under~     different range of neuromuscular blockade.Therefore, acceptable neuromuscular blockade~     threshold (determined by TOF test) acceptable for obtaining reliable screw stimulation test~     should be determined. Screw stimulation test may be performed when neuromuscular blockade is~     absent and compared to repeated screw stimulation test when neuromuscular blockade is~     present. Different levels of neuromuscular blockade may provide different results on screw~     stimulation test, so if difference is statistically significant, induced neuromuscular~     blockade level may be set as threshold value, acceptable for obtaining reliable testing~     results.~   "
97898|NCT02285816|"~     This research is being done because these viruses have been shown to shrink tumours in~     animals and human tumour samples by selectively killing cancer cells and creating an immune~     response to the tumour antigen contained in the viruses. This effect has been shown to~     increase when the AdMA3 virus is given first. It is not clear if this treatment will offer~     better results than standard treatment.~   "
97899|NCT02285803|"~     The aim of this study is to evaluate the added effect of tDCS to TRT within patients with~     chronic, non-pulsatile tinnitus. Patients were randomised in two groups namely, TRT and real~     tDCS and the second one is TRT with sham tDCS. Evaluations took place at the start of~     therapy, at the end of the counselling and at last a follow-up visit will be planned after 84~     days of the start of the therapy. Subjective outcome measurements such as Tinnitus Functional~     Index and Visual Analogue Scales of loudness are the primary outcome measurement. Secondary~     outcome measurements are the Hospital Anxiety and Depression Scale, hyperacusis questionnaire~     and psychoacoustic measurements.~   "
97900|NCT02285790|"~     The purpose of this study is to assess the efficacy and safety of the one-stop-shop concept,~     using real-time in vivo reflectance confocal microscopy as diagnostic tool, prior to surgical~     management of new primary basal cell carcinoma~   "
97901|NCT02285777|"~     This is extension of the V102_16 study (NCT02140762). V102_16E1 is designed to assess the~     effectiveness of a 3-dose vaccination series of MenABCWY, administered according to 0, 2, 6~     month schedule, against the same panel of endemic US N. meningitidis serogroup B strains, as~     measured by enc-hSBA assay. The subjects who completed the parent V102_16 study will be~     invited at the time of their last study visit to participate in this extension study.~   "
97902|NCT02285764|"~     The purpose of this study is to investigate the potential effects of a modified carbohydrate~     nutritional product for obese pregnant women to reduce maternal glycemia.~   "
97903|NCT02285751|"~     High on treatment platelet reactivity is defined as a poor pharmacodynamic response to the~     administration of acetylsalicylic acid or clopidogrel. acetylsalicylic acid and clopidogrel~     are drugs commonly used to reduce platelet activity and prevent cardiovascular events. High~     on treatment platelet reactivity is associated with a higher cardiovascular event rate.~      Ticagrelor and prasugrel, like clopidogrel both P2Y12 inhibitors are effective in treating~     patients with High on treatment platelet reactivity to clopidogrel.~      Critically ill patients are a unique population with altered pharmacokinetic and~     pharmacodynamic properties. Gastrointestinal dysmotility with associated altered resorption~     and impaired microvascular function occur frequently in critically ill patients and may lead~     to altered resorption of orally administered drugs.~      The investigators will test a minimum of 100 patients treated with 100mg acetylsalicylic acid~     per os and 100 patients treated with 75mg clopidogrel per os to calculate the prevalence of~     high on treatment platelet reactivity.~      30 patients with high on treatment platelet reactivity to acetylsalicylic acid will be~     randomized to three new treatment groups. In the first group patients will receive 200mg~     acetylsalicylic acid per os, in the second group 100mg acetylsalicylic acid intravenously and~     in the third group 81mg chewable acetylsalicylic acid. Each group will contain 10 patients.~     Pharmacokinetics and pharmacodynamics will be reassessed to evaluate the new treatment.~      36 patients with high on treatment platelet reactivity to clopidogrel will be randomized to~     receive either an additional loading dose of 600mg clopidogrel (n=24) or to continue normal~     treatment as a control group (n=12). Pharmacokinetics and pharmacodynamics will be reassessed~     and those patients, who are tested again to have high on treatment platelet reactivity in~     spite of the additional loading dose, will now be randomized to receive either ticagrelor or~     prasugrel. The investigators expect about six patients per group. The twelve patients in the~     control group will continue normal treatment (75mg/day) until the end of the study.~     Pharmacokinetics and pharmacodynamics of ticagrelor and prasugrel will be assessed. Any~     patient, who is tested again with high on treatment platelet reactivity in spite of~     receiving prasugrel or ticagrelor, will be finally switched to the opposite drug and a final~     high on treatment platelet reactivity testing will be conducted.~      16 patients who are treated with 10mg prasugrel per os will be tested for HTPR and if~     positively tested will be switched to 2x90mg ticagrelor per os per day. Platelet reactivity~     will be reassessed to test whether switching the medication benefits the patients.~   "
97904|NCT02285738|"~     This research study examines the safety and feasibility of aspirin with or without~     Simvastatin in solid tumor patients at risk for VTE (Venous Thromboembolism - or blood clots~     - in the arms, lets, lungs, or other part of the body). One-fifth of all thrombotic~     (clotting) events occur in patients that have cancer. Changes in sP-selectin will be used as~     a measure of efficacy. We have chosen sP-selectin as the primary marker because of its role~     in hemostasis, because it is predictive of thrombosis in cancer patients and because of~     promising preliminary data. We expect that sP-selectin levels will be elevated in patients~     before therapy with aspirin and/or statin, but that these levels will fall significantly~     during treatment, rise during the observation phase, and fall during the second study period.~     Patients who take part in the study have been diagnosed with a solid tumor cancer and are~     considered to be intermediate to high risk for VTE. The standard of care is to give~     chemotherapy for solid tumors and treat clots which develop using blood thinners.~   "
97905|NCT02285725|"~     This study seeks to evaluate a treatment for multiple full thickness chondral lesions in the~     knee. Eligible subjects will undergo a microdrilling surgery and up to 12 post operative~     intra-articular injections of bone marrow aspirate concentrate (BMAC), platelet rich plasma~     (PRP) and hyaluronic acid (HA).~   "
97906|NCT02285712|"~     Peripheral intravenous access is a major intervention in patients admitted to an intensive~     care unit. Systematically performed by nurses, it is also an essential intervention when the~     central venous access has to be removed. However, in the intensive care unit, patient~     centered-characteristics such as previous history of intravenous drug abuse, obesity, history~     of multiple vascular punctures or fluid overload most often affect the success rate of this~     procedure. For these patients, failure consequences are numerous: 1) delayed discharge from~     the intensive care unit, 2) increased pain and dissatisfaction, 3) increased incidence of~     catheter-related bloodstream infections. The use of ultrasound has gained increasing~     popularity particularly for obtaining central venous access. We hypothesize that, among~     trained nurses, ultrasound-guided peripheral venous access could represent an attractive~     alternative compared to the traditional anatomical method in order to increase the success~     rate.~   "
97907|NCT02285699|"~     This study will examine the gut microbiota and serum inflammatory markers in patients with~     Obsessive-Compulsive Disorder vs. healthy controls. Phase II of the study will examine the~     gut microbiota and cytokine levels following 12-weeks of treatment with Selective Serotonin~     Reuptake Inhibitors (SSRIs).~   "
97908|NCT02285686|"~     Troponins are sensitive and specific markers of cardiac injury. Critically ill patients~     frequently have elevated troponins. In this population, distinguishing patients with elevated~     troponins from those with myocardial infarction is difficult. However, troponin elevations on~     their own seem to be associated with an increased risk of death. The optimal treatment of~     patients with type 2 myocardial infarction or non ischemia related troponin elevations during~     critical illness is unclear. There are no trials in the ICU setting to guide management.~      This study is a 1-month pilot cohort study of troponin screening in 4 Ontario intensive care~     units. The objective of this pilot study is to evaluate the ability to perform a larger~     study, which will determine the prevalence, incidence and risk factors for elevated troponin~     values, how patients with elevated troponin values are treated as a baseline, and the~     incidence of myocardial infarction in critically ill patients. Knowing the prognostic impact~     of these conditions and understanding current management will thereafter guide researchers~     and clinicians on the importance of carefully evaluating potential risk-modifying therapies.~   "
97909|NCT02285673|"~     Duchenne muscular dystrophy (DMD) is a genetic disorder caused by an absence of dystrophin~     and characterized by progressive muscle degeneration. There is no cure for DMD at present~     but, there are several strategies under-researched for treatment of DMD such as steroid~     treatment, gene theraphy, exon skipping, stop codon read through and gene repair, cell~     theraphy and theraphy with drug that help to produce utrophin protein.~      The aim of this study is investigate the eficacy of human umblical cord mesenchymal stem~     cells on DMD and understanding if wild type gene can be transfered to the patient.~   "
97910|NCT02285660|"~     The aim of high dose radiotherapy treatment is to deliver enough radiation to the tumour to~     kill all the cancer cells while at the same time giving a low dose of radiation to the normal~     parts of the body to reduce the side effects of treatment. This requires the cancer~     specialist to accurately identify the areas of cancer on a computed tomography (CT) scan.~     Positron emission tomography computed tomography (PETCT) scans use radioactive sugar that is~     injected into the patient. This sugar goes into cancer cells and shows up as a bright spot on~     the PET scan, allowing the doctors to see tumours more accurately. Some cancers move with~     breathing, for example lung, pancreas and oesophageal (or gullet) cancers. Fourdimensional CT~     scanning (4DCT) is a special type of CT scan that allows the motion of the tumour to be seen~     and measured accurately. This information can then be used to help ensure that the~     radiotherapy correctly treats the moving tumour.~      The aim of this study is to see if there are possible benefits to combining PET with 4DCT to~     get a 4D PETCT scan for tumours that move with breathing. This study is divided into three~     cancer types; lung, lower oesophagus and pancreatic cancer.~      First the investigators are going to test the use of 4D PETCT in the radiotherapy planning of~     these tumours to see if it helps the doctor to identify the cancer.~      Secondly, the investigators are going to see if the 4D PETCT helps to show areas within the~     cancer that are potentially more active. This might then allow us to target a higher dose to~     these areas, which could potentially improve the chance of controlling and curing the cancer.~     Patients' standard treatment will not be altered by participating in the study.~   "
97911|NCT02285647|"~     This is an open-label, randomized, single-dose, single-center, parallel-group bioequivalence~     study of orally- and IV-administered rolapitant in healthy male and female subjects.~   "
97957|NCT02285049|"~     Chronic urticaria symptoms commonly fluctuate from day by day. Consequently the clinical~     presentation of a patient in each visit is not representative of the current disease status.~     Dermatologists are trying to integrate an evaluation process of each treatment visit~     regarding both clinical condition and life quality concern. The Urticaria Control Test is the~     key for a better treatment outcome in a routine management. To translate this questionnaire~     into Thai is essential in our subject of interest for offering local patients a higher~     well-being standard. The Thai-version test will encourage enhanced as well as impactful~     therapeutic options for Thai chronic urticaria patients.~   "
97912|NCT02285634|"~     Nosebleeds (epistaxis) are a frequent cause of emergency department visits, reportedly~     inciting 1 in 200 visits. They are most common in those less than ten and older than seventy,~     often occurring in the winter months secondary to dry indoor heating. Epistaxis is associated~     with elevated blood pressures, but it is controversial whether hypertension is actual a~     contributing cause.~      In non-life-threatening epistaxis, the first step in management is commonly the application~     of a topical vasoconstrictive medication. In many cases this will lead to cessation of the~     bleeding or facilitate the exam in those that continue to bleed. Frequently used medications~     include phenylephrine, oxymetazoline, and lidocaine with epinephrine.~      Classic teaching has been to avoid the use of these medications in patients with elevated~     blood pressures due to concerns of inducing hypertensive crisis. Strict avoidance of topical~     vasoconstrictors in this patient group with epistaxis severely limits the treatment options~     for a many patients given the association between the two conditions.~      Though universally taught, the actual effect of these agents on blood pressure remains~     unquantified. Studies investigating the prevention of nose bleeding during nasotracheal~     intubations suggest that the effect might be minor with little variation between agents.~      Clinical question:~      What is the effect of commonly used intranasal vasoconstrictors on blood pressure in~     volunteers without a history of hypertension.~   "
97913|NCT02285621|"~     Adolescent Idiopathic scoliosis affects 3-4% of the Canadian population, of which about 10%~     will need a brace treatment during pubertal growth spurt. The design is made relatively~     corsets empirically, hence the relative efficiency of this treatment. Our team has developed~     innovative methods for design, optimization and computer aided manufacturing-based numerical~     simulation models customized to each patient, and a system of evaluation and adjustment of~     corsets. In this project, the investigators will evaluate the effectiveness of this platform~     customized treatment and demonstrate its clinical application~   "
97914|NCT02285608|"~     Investigators are doing this study to examine if a new personalized education program for~     patients with mood disorders (depression and bipolar disorders) will help them take their~     medications as prescribed by doctors. Investigators will teach patients about how, when and~     why it is important for them to take their medications as prescribed. Also, investigators~     will ask patients why they do not take medications as prescribed. Furthermore, investigators~     will examine whether our education program might save money if it prevents problems related~     to not taking medication.~   "
97915|NCT02285595|"~     A prospective, literature controlled, clinical study evaluating healing rates for the Sonendo~     GentleWave System in the treatment of 1st and 2nd molars indicated for root canal therapy.~   "
97916|NCT02285582|"~     The rare histiocytic disorders (RHDs) are characterized by the infiltration of one or more~     organs by non-LCH histiocytes. They can range from localized disease that resolves~     spontaneously, to progressive disseminated forms that can be sometimes life-threatening.~     Since they are extremely rare, there is limited understanding of their causes and best~     treatment options. Physicians, patients and parents of children with RHDs frequently consult~     members of the Histiocyte Society regarding the best management of these disorders. Very~     often, no specific recommendation can be made due to the lack of prospective outcome data, or~     even large retrospective case series. The creation of an international rare histiocytic~     disorders registry (IRHDR) could facilitate a uniform diagnosis of the RHDs, as well as the~     collection and analysis of the clinical, epidemiological, treatment and survival data of~     patients with RHD. The registry may also lead to future therapeutic recommendations, provide~     a framework for future clinical trials and create excellent research opportunities.~   "
97917|NCT02285569|"~     During a caesarean section the blood pressure is usually measured every few minutes and it~     may fall too quickly to be detected in a timely fashion by this intermittent means. The~     monitor the Masimo Rainbow SET® (MRS) uses a peg attached to a finger to detect (amongst~     other things) the flow of blood through it. One of the measures it takes is called the Pleth~     Variability Index (PVI) which (unlike standard blood pressure measurement) it measures~     continuously. The investigators would like to try the MRS on patients to see if the PVI can~     be used to predict falls in blood pressure.~   "
97918|NCT02285556|"~     The purpose of this research is to inspire new medical ideas using brain image technology for~     the treatment of Amphetamine Type Stimulus addition, at the same time lowing the addition~     damage.~   "
97919|NCT02285543|"~     To confirm the subgroup result from TPF (docetaxel, cisplatin and 5-fluorouracil ) trial~     (NCT01542931) that cN2 OSCC patients could benefit from TPF induction chemotherapy compared~     to the standard treatment.~   "
97920|NCT02285530|"~     The purpose of this study is to confirm the predictive value of GDF15 expression for TPF~     induction in T3/T4cN0M0 patients with OSCC~   "
97921|NCT02285517|"~     This is a clinical trial study that compare two plastic surgery techniques in patients with~     third degree of burning and both techniques are used in all patients but in different areas~     of burning sites of the patients.~   "
97922|NCT02285504|"~     This is an open-label proof-of-concept study designed to evaluate the safety, tolerability,~     PK, and efficacy of SAGE-547 Injection in adult female patients diagnosed with severe~     postpartum depression (PPD).~   "
97923|NCT02285491|"~     Local anesthetic will be injected into both angles of the rectus sheath incision in an~     attempt to block sensory nerves in this area that cause the sensation of pain from lscs~     wound.~   "
97924|NCT02285478|"~     Darunavir/ritonavir is one of the preferred antiretroviral agents as part of combination~     antiretroviral therapy for treatment of HIV-infected adults according to international~     guidelines. For children 3-12 years old, FDA has approved once daily dosing of~     darunavir/ritonavir. Dosing recommendations for children 6-12 years old have been approved~     based on a modelling and simulation procedure by the company.~      This pharmacokinetic study is designed to validate the proposed dosing recommendation for~     once daily darunavir/ritonavir in HIV-infected children aged 6-12 years old.~   "
97925|NCT02285465|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of~     ascending multiple oral doses of ASP3700 in healthy subjects.~   "
97926|NCT02285452|"~     In integrative medicine wraps are applied for different indications. In this study the~     effects of thorax with ginger and mustard flour are investigated under standardized~     conditions. Heart rate variability, well being, warmth distribution and respiratory activity~     of healthy subjects will be measured.~   "
97927|NCT02285439|"~     The main purpose of phase I studies in general is to determine the best dose (maximum~     tolerated dose) of a drug, and to find out the most common side effects. The main purpose of~     the phase I component of this study specifically is to determine the best dose of the~     experimental drug MEK162 and to find out whether the drug is safe in children and adolescents~     with tumors that have grown or come back despite standard therapy.~      Another purpose of this study is to measure the concentration of drug in the blood to help~     understand how much drug gets into the body and how quickly the drug is removed from the~     body. Another purpose of this study is to determine whether MEK162 turns off the Ras/Raf/MAP~     pathway as expected by measuring this pathway in blood cells. Finally, in this study, the~     investigators hope to start finding out whether or not MEK162 causes different types of~     tumors in children to shrink or stop growing.~      The main purpose of the phase II component of the study is to determine whether MEK162 causes~     specific types of tumors in children and adolescents to shrink or stop growing. These~     specific types of tumors include low-grade gliomas, tumors in patients with a genetic~     condition called neurofibromatosis type 1, and other tumors thought to be caused by abnormal~     activation of the Ras/Raf/MEK molecular pathway.~      Another purpose of this study is for researchers to learn whether specific abnormalities in~     the DNA of tumors can help predict whether tumors will respond to MEK162.~   "
97928|NCT02285426|"~     Videobronchoscopy is an essential diagnostic procedure for evaluation of the central airways~     and pivotal for the diagnosis and staging of lung cancer. Further technological improvements~     have resulted in high definition (HD+) images and advanced image enhancement technique~     (i-scan). An earlier study (NCT01676012) has indicated that HD+ bronchoscopy in combination~     with i-scan technology is superior to HD+WL (white light) for detecting endobronchial~     vascular changes. In this study we aim to correlate these vascular changes to histology and~     hypothesize that these vascular changes are related to (pre-) malignant changes and that the~     addition of i-scan is superior to HD+ WL.~   "
97929|NCT02285413|"~     This is an exploratory study and the primary objective is the immunogenicity and feasibility~     of combined chemotherapy-DC vaccination. The secondary objectives are the toxicity and~     clinical efficacy. This study will provide important data on the immunological efficacy of DC~     immunochemotherapy.~   "
97930|NCT02285400|"~     Chronic Obstructive Pulmonary Disease (COPD) is a common respiratory disease characterized by~     airflow limitation that is progressive and not fully reversible. Expiratory flow limitation~     (EFL) is the main mechanism leading to dynamic pulmonary hyperinflation (DPH) and intrinsic~     positive end-expiratory pressure (PEEPi). DPH and PEEPi lead to increased inspiratory muscle~     efforts and impaired central drive mechanical and ventilation coupling, which is an important~     mechanism of dyspnea. Appropriate setting of extrinsic PEEP (PEEPe) can decrease inspiratory~     efforts and work of breathing, improve patient-ventilator synchrony in severe COPD patients~     with PEEPi and treated with mechanical ventilation. Nevertheless, the effects of CPAP/PEEPe~     level on respiratory mechanics, especially on central drive mechanical and ventilation~     coupling, still need further investigations.~      In the present study, about 40 patients with COPD will be recruited as research subjects. And~     the investigators aim to observe the changes in respiratory mechanics, central drive~     mechanics, central drive mechanical and ventilation coupling at different levels of CPAP.~     Contrast analysis will be conducted to evaluate the effects of CPAP level on respiratory~     mechanics and central drive during DPH, which may provide a reasonable basis for the clinical~     application of CPAP to COPD patients and the exploration of a new reasonable CPAP setting~     method.~   "
97931|NCT02285387|"~     Prospective randomized (rhythm control or rate control) Objective of study~        1. To analyze long term outcome of patients with acute stroke with atrial fibrillation~          according to the rhythm control~        2. To analyze recurrence rate of atrial fibrillation or recurrence stroke in patients with~          acute stroke according to the rhythm control (by antiarrhythmic drug, cardioversion,~          catheter ablation)~   "
97932|NCT02285374|"~     This is a phase IV, open label, multicentre trial that will be taking place at 4 sites in the~     United Kingdom (UK). Efavirenz which is taken in combination with Kivexa® or as part of the~     combination pill, Atripla® is a recommended firstline regimen for the treatment of Human~     Immunodeficiency Virus-1 (HIV- 1) infection. Treatment against the HIV virus is also referred~     to as antiretroviral therapy.~      Toxicity is the most common reason for modification of firstline therapy. Central Nervous~     System (CNS) side effects such as difficulty with sleeping & bad dreams are common side~     effect of Efavirenz based therapy and is one of the most frequent reasons for switching or~     discontinuing highly active antiretroviral therapy.~      Dolutegravir is within a novel class of antiretroviral agents licensed in the UK for the~     treatment of HIV. In combination with Truvada®, it showed fewer side effects when compared to~     Efavirenz in other clinical studies, where patients were starting HIV treatment for the first~     time, or switching from other agents.~      The purpose of the study is to investigate the benefits of switching away from Eefavirenz (in~     combination with Kivexa® or as part of the combination pill, Atripla®) to Dolutegravir in~     patients with CNS side effects (such as difficulty with sleeping, bad dreams etc).~   "
97933|NCT02285361|"~     To monitor the safety profile and efficacy of GIOTRIF®(afatinib dimaleate, q.d) in Korean~     patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)~   "
97934|NCT02285348|"~     Ataxia telangiectasia (A-T) is a rare devastating human recessive disorder characterized by~     progressive cerebellar ataxia, immunodeficiency, chromosomal instability, and cancer~     susceptibility. The underlying mechanism and process of neurodegeneration leading to loss of~     cerebellar neurons and neurological function is largely unknown. Laboratory diagnostic~     approaches to neurodegeneration in A-T are hampered by sampling issues. It is dangerous,~     impractical, and not ethically to directly sample brain tissue by surgical biopsy. In~     contrast cerebrospinal fluid (CSF), a fluid that is in direct contact with brain tissue, is~     relatively easy to sample in a safe procedure (lumbar puncture). The aim of the proposal is~     to investigate oxidative stress, low grade inflammation and tissue break down in the brain of~     A-T patients by analyzing CSF. In addition the alterations in protein expression related to~     A-T will be quantified by liquid chromatography/mass spectrometry (LC/MS)-based proteomic~     analysis of CSF from healthy individuals and A-T patients to determine candidate proteins~     (new biomarkers) which relative expression levels could be used as surrogate marker of~     disease progression.~   "
97935|NCT02285335|"~     The purpose of the study is to evaluate the effect of GINST on human semen. The study is a~     pilot study, designed as open-label, prospective randomized clinical trial using GINST either~     500mg/capsule (panax ginseng 0.96g/day) or 1000mg/capsule (panax ginseng 1.92g/day), two~     capsules at once, three times a day for 12 weeks. GINST(Ilhwa, Republic of Korea) is a~     dietary supplement capsule, which is made with 6 year-old Korean red ginseng (Panax ginseng).~     Expected participants are to be male partners of female patients who visit infertility clinic~     at Severance hospital, whose total motile sperm count is more than 0.5x106 by semen analysis~     using computer aided sperm analyzer (CASA). Semen analysis, blood test, questionaires are~     planned to be performed 2 times, on the initial visit and after 12weeks of GINST treatment.~     Semen analysis will reveal ejaculated volume, sperm count, motility, morphology, total~     leukocyte count, total motile sperm count, further analysis including sperm chromatin~     assessment to examine the quality of sperm and malondialdehyde (MDA) analysis of seminal~     fluid to assess oxidative stress will be performed. Blood test will be done including serum~     follicle stimulating hormone (FSH), luteinizing hormone (LH), total and free testosterone.~     Quality of life, sexual performance before and after taking GINST will be evaluated using~     questionaires.~   "
97936|NCT02285322|"~     Current guidelines for the clinical management of hypertension in adults recommend to achieve~     and maintain blood pressure levels of <140/90 mmHg. However, it is uncertain what proportion~     of individuals identified with high blood pressure in primary care actually reach blood~     pressure control, what factors are associated with attainment of control and to what extent~     blood pressure control attainment is associated with cardiovascular diseases in a~     contemporary population of individuals diagnosed with high blood pressure.~      The aim of this study is to investigate the extent to which patients achieve blood pressure~     control and associated risk factors, time to attainment of blood pressure control and whether~     this time is associated with an increased risk of CVD onset, all-cause and cardiovascular~     disease and end-stage renal disease.~   "
97937|NCT02285309|"~     This observational clinical trial will investigate the following perioperative indices~     relating to cardiac surgery:~        1. The significance of measurements involving left heart relaxation (LV diastolic function)~          and its relation to outcome measures.~        2. The significance of measurements involving right heart relaxation function and itrs~          relation to outcome measures.~        3. The influence of drugs such as enoximone on these outcome measures.~   "
97938|NCT02285296|"~     Elderly cancer patients need more help from their relatives and for longer than young adults.~      Our hypothesis of research is that the needs and resources to help the couple  elderly~     patient/caregiver , are at least in part socially determined and that the implementation of~     a personalized support plan to help the caregiver (PSP) taking into account needs, resources~     and expectations of the primary caregiver in addition to those of elderly patients with~     cancer may partly correct inequalities. The PSP should allow a better management of cancer, a~     lesser burden for the caregiver and a better quality of life for both the caregiver and the~     patient.~   "
97939|NCT02285283|"~     The purpose of this randomized controlled double-blinded trial is to determine if the~     addition of an oral antifungal to typical post-operative medical therapy can prevent or~     reduce the incidence of recurrence of nasal polyps in fungal sensitive patients with chronic~     rhinosinusitis with nasal polyps (CRSwNP).~   "
97940|NCT02285270|"~     Brown adipose tissue is poorly understood fat that can metabolize glucose in order to~     generate heat. Since activated brown fat has a high metabolic rate, it is of great interest~     as a potential target to combat obesity. However, the signaling and control of brown fat~     metabolism is poorly understood. Because brown fat uses glucose as its energy source, brown~     fat metabolism can be imaged with PET/CT using the positron emitting glucose analog F-18 FDG.~     We have recently shown in mice a striking circadian variation in brown fat metabolism as~     evidenced by changes in FDG uptake. In this study we endeavor to generate pilot data on a~     potential circadian variation in brown fat activation in healthy humans.~   "
97941|NCT02285257|"~     The purpose of this study is to determine the epidemiology and outcome of sepsis at Yuetan~     subdistrict in Beijing in mainland China).~   "
97942|NCT02285244|"~     This phase II trial studies how well sotrastaurin acetate works in treating patients with~     chronic lymphocytic leukemia, small lymphocytic leukemia, prolymphocytic leukemia, or~     Richter's transformation that has returned or that does not respond to treatment.~     Sotrastaurin acetate may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth.~   "
97943|NCT02285231|"~     In this double-blind, placebo-controlled study, subjects with prediabetes and type 2 diabetes~     were randomly assigned to the placebo control group or the test (Arginyl-fructose: AF) group.~     We determined fasting serum levels of glucose, hemoglobin A1c (HbA1c), insulin, and free~     fatty acids (FFAs), were measured by 2-h oral glucose tolerance tests (OGTTs) at baseline and~     after the 6-week intervention.~   "
97944|NCT02285218|"~     To investigate the predictive roles of adipokines and hepatokines to detect non-alcoholic~     fatty liver disease (NAFLD), diabetes, or dyslipidmia.~      To examine the association or effects of clinical and biochemical factors (lab results and~     medication, etc.) on serum levels of adipokines and hepatokines in certain subjects with~     non-alcoholic fatty liver disease (NAFLD), diabetes, or dyslipidmia.~   "
97958|NCT02285036|"~     A newly 23-valent pneumococcal polysaccharide vaccine was developed with promising safety and~     immunogenicity demonstrated in the phase III trial in China. A large scale, double blind,~     randomized, PNEUMOVAX 23 (Merck & Co., Inc.) controlled phase 3 clinical trial was conducted.~   "
97959|NCT02285023|"~     In the majority of patients with the chronic urticaria, the etiology is unclear, leading to~     difficulties in treatment and high rates of recurrence. According to the International~     EAACI/GA2LEN/EDF/WAO Guidelines (the Dermatology Section of the European Academy of~     Allergology and Clinical Immunology(EAACI), the Global Allergy and Asthma European Network~     (GA2LEN), the European Dermatology Forum (EDF) and the World Allergy Organization (WAO) in~     Urticaria, using the Chronic Urticaria Quality of Life Questionnaire in a routine management~     is the key for a better treatment outcome. To translate this questionnaire into Thai is~     essential in our subject of interest in order to effectively apply it to local patients. The~     Thai-version questionnaire will encourage enhanced as well as impactful therapeutic options~     for Thai chronic urticaria patients.~   "
97945|NCT02285205|"~     Lobeglitazone is highly selective peroxisome proliferator-activated receptor-gamma agonist~     that decreases insulin resistance in the periphery and liver resulting in increased~     insulin-dependent glucose disposal and decreased hepatic glucose output. In vivo, It~     demonstrates that Lobeglitazone improves even more glycemic and lipid control in comparison~     to rosiglitazone and pioglitazone. Currently, thiazolidinediones such as pioglitazone is the~     only drug which is considered as an effective therapeutic agent for improving non-alcoholic~     fatty liver disease (NALFD) in type 2 diabetes (T2D).~      The aim of this multicenter, prospective, open-labeled, single-arm, exploratory phase 4 study~     is to evaluate the efficacy and safety of Lobeglitazone once daily for 24 weeks on~     intrahepatic fat contents assessed by transient elastography (fibroscan) in T2D with NAFLD.~      Fifty subjects with T2D and NAFLD will take Lobeglitazone (0.5mg/tablet, orally, 1 tablet~     once daily) for 24 weeks.~      Primary endpoint is changes from baseline in controlled attenuation parameters (CAP) measured~     by transient elastography (fibroscan) after treatment with Lobeglitazone.~      Secondary endpoints are changes from baseline in glycemic profiles (HbA1c, Glycated albumin),~     Lipid parameters (Total Cholesterol, Triglycerides, HDL-C, LDL-C), Liver function parameters~     (AST, ALT, r-GT), and adverse events during the trial.~   "
97946|NCT02285192|"~     The purpose of this study is to see if a radioactive substance called 18F-Fluorodeoxyglucose~     (18F- FDG), injected into the cervix during a PET/CT scan done before surgery can show us~     more clearly which lymph nodes in the pelvis (the area near your uterus and cervix) contain~     cancer.~   "
97947|NCT02285179|"~     This study is designed as a phase 1 dose escalation study followed by a randomised phase II~     study. The study will be performed in three different centres: Addenbrooke & Cambridge~     university (Cambridge, UK), Netherlands Cancer Institute Amsterdam), and Vall d'Hebron~     Hospital (Barcelona, Spain).~      Three to six patients will be followed for one completed cycle of therapy (28 days) and~     subsequent enrolment of new cohorts will be based on the safety assessment in that first~     cycle and the documentation of dose limiting toxicities. To determine the safety and efficacy~     of tamoxifen in combination with the isoform selective Pi3K inhibitor GDC-0032 compared with~     tamoxifen alone.~   "
97948|NCT02285166|"~     The purpose of this survey is to determine the incidence rate of cardiovascular (CV) events~     associated with long-term treatment with and without omega-3 fatty acid ethyl esters (Lotriga~     Granular Capsules) in high-risk hyperlipidemic patients treated by statin in daily medical~     practice.~   "
97949|NCT02285153|"~     Platelets play a central part not just in homeostasis and thrombosis as the primary effector~     cells, but they are also key cells in the regulation of the immunological response to various~     stressors. After activation, platelets release their granules which store different~     inflammatory mediators that induce coagulation, recruit further platelets, activate~     complement, attract neutrophils and leukocytes and regulate the vascular tone. Platelets~     activated by systemic inflammation and infection, may also contribute to the development of~     multiple organ failure. Thus, inhibition of platelet activation may have beneficial effects~     on critically ill patients.~      the investigators hypothesize that acetylsalicylic acid reduces the mortality of medical~     intensive care unit patients. In a retrospective study acetylsalicylic acid use was~     associated with a substantial reduction in a medical intensive care unit population (Winning~     et al., 2010).~      The investigators will conduct a randomized, double-blind study including 460 patients~     (2x230), who will be randomized to receive 100mg acetylsalicylic acid(daily, intravenous) or~     a placebo (0,9% sodium-choride solution) to assess whether acetylsalicylic acid reduces the~     mortality of medical intensive care unit patients.~      Main outcome criteria will be 28/90day-mortality. Furthermore the investigators will assess~     whether acetylsalicylic acid reduces the risk of suffering thromboembolic complications.~      Post-mortem examinations will be conducted in all patients who die in the course of the~     study.~      Furthermore we will assess bleeding rates, intensive care unit mortality and pharmacokinetic~     and pharmacodynamic properties of acetylsalicylic acid in the intensive care unit population.~   "
97950|NCT02285140|"~     There is clinical equipoise about the question of whether antibiotic prophylaxis should be~     given for a short period or an extended period of time as reflected by inconsistencies in~     major guidelines, current practices at Canadian centers, and as concluded in the three~     systematic reviews. There also is clinical equipoise on whether the addition of vancomycin to~     routine cefazolin prophylaxis can further reduce s-SSI rates. A short duration of combined~     antimicrobial prophylaxis can reduce side effects of exposure to antimicrobials such as~     infections with C. difficile or emergence of resistance, but may also reduce the incidence of~     s-SSIs. The objective of the eventual full scale study is to determine whether adding~     vancomycin to cefazolin can reduce SSIs as well as whether short-term prophylaxis is as~     effective as long-term prophylaxis. The rationale to conduct the proposed pilot study is to~     assess the feasibility to conduct this factorial cluster randomized cross-over trial, the~     adherence to the study protocol at each pilot site, the length of time to fill out the case~     report forms, and to get reliable estimates of event rates for sample size calculation for~     the main study~   "
97951|NCT02285127|"~     Is there a functional outcome difference when treating pertrochanteric fractures with a short~     or long cephalomedullary nail?~   "
97952|NCT02285114|"~     This study will evaluate the pharmacokinetics (PK), safety, and efficacy of~     emtricitabine/tenofovir alafenamide (F/TAF) in HIV-1 infected children and adolescents~     virologically suppressed (defined as having < 50 copies/mL of HIV-1 RNA for a period of at~     least 6 months) while on a stable 2-nucleoside/nucleotide reverse transcriptase inhibitor~     (NRTI) containing regimen.~   "
97953|NCT02285101|"~     The goal of this clinical research study is to evaluate the safety of PEG-BCT- 100 given as~     an infusion to treat patients who bear advanced solid tumors that are dependent on arginine~     (melanoma, renal cell carcinoma, prostate cancer and hepatocellular carcinoma), and who have~     progressed after receiving approved or established therapies. This is a Phase 1 study;~     PEG-BCT-100 is an enzyme that degrades arginine and is an investigational drug.~   "
97954|NCT02285088|"~     The purpose of this study is to assess the safety, tolerability, pharmacokinetic, and~     pharmacodynamic effects of GBT440 compared with placebo in healthy subjects and subjects with~     sickle cell disease (SCD).~   "
97960|NCT02285010|"~     This study aims to compare the effect of pre-operative oral pregabalin on post operative~     morphine consumption after abdominal hysterectomy with/without salpingo-oophorectomy.~   "
97961|NCT02284997|"~     Along the edge of the eyelids, there are glands (meibomian glands) that produce and deliver~     oils (meibum) onto the tear film. These oils serve to slow down the evaporation of tears. The~     meibomian glands may become obstructed due to change in meibum quality. When meibum thickens~     and solidifies, it plugs the gland openings and oils can no longer reach the tear film. The~     blockage of the glands is the primary cause of meibomian gland dysfunction (MGD), and may~     result in symptoms of dry eye (burning, stinging, grittiness, etc.). The typical treatment~     for MGD is a procedure called warm compresses. It is a combination of applying heat and~     pressure to the eyelids for approximately 10 minutes to melt the meibum, unplug the gland~     openings, and allow oils to flow normally onto the tear film once again. One way to apply~     heat to the eyelids is by using the MGDRx® EyeBag. The EyeBag is microwaved for 30-40 seconds~     under full power, and is placed over the closed eyes for approximately 10 minutes. The eyes~     are gently massaged afterwards.~      The purpose of this study is to determine how effective the EyeBag is at improving MGD and~     dry eye symptoms.~   "
97962|NCT02284984|"~     The present study investigates the potential of a new therapeutic approach in lupus nephritis~     combining rituximab (anti-CD20) and belimumab (anti-BAFF). The main goal of the study is to~     assess the reduction (and seroconversion) of pathogenic autoantibodies, to evaluate clinical~     improvement and assess the safety and feasibility of long-term B-cell depletion.~   "
97963|NCT02284971|"~     This study evaluates the combination of stereotactic body radiation therapy (SBRT) and~     CDX-1127 in subjects with castration resistant prostate cancer. Subjects will be randomized~     to one of three arms to receive SBRT prior to, after, or in conjunction with the first dose~     of CDX-1127.~   "
97964|NCT02284958|"~     This study will investigate if a 12-week, individually-tailored walking program, using~     pedometers will be a more clinically and cost-effective option for the management of chronic~     low back pain than standardized advice and education.~   "
97965|NCT02284945|"~     Spread of cancer to the spinal column is a growing problem in patients with cancer. It can~     cause a number of problems including pain, instability and neurologic problems. If left~     untreated, progressive weakness, numbness and bladder/bowel disturbance occurs. The aim of~     treatment is to help with pain and to reduce the risk of these neurological problems. This~     treatment has traditionally been radiotherapy to the spine. Surgery has always meant large~     open operations with a long recovery time and significant risk of complications. There has~     been new technology that has allowed less invasive operations to take place to stabilise the~     spine. The aim is to relieve the pressure on the spinal cord in addition to stabilising the~     spinal cord. These techniques are called 'minimally invasive' and include surgical techniques~     such as cement augmentation and percutaneous instrumentation.~      The aim of this study is to compare traditional open operations with these new minimally~     invasive techniques to see if they do result in reduced complications and quicker recovery in~     addition to achieving the goals of surgery.~   "
97966|NCT02284932|"~     Limb muscle dysfunction, characterized by atrophy and weakness, is amongst the most~     troublesome systemic consequences of chronic obstructive pulmonary disease (COPD) leading to~     poor functional status and premature mortality.~      One prevailing hypothesis stipulates that the deterioration in muscle structure and function~     during COPD results from a spillover of inflammatory mediators from the lungs to the systemic~     circulation and then to the muscles.~   "
97967|NCT02284919|"~     In this study, positron emission tomography (PET/CT) imaging will be used to evaluate sigma-2~     (σ2) receptor activity in sites of primary breast cancer using the investigational~     radiotracer [18F]ISO-1.~   "
97968|NCT02284906|"~     The purpose of this study is to evaluate the effect of pioglitazone at 24 months compared~     with placebo on cognitive decline in high-risk participants who have completed the~     AD-4833/TOMM40_301 study [NCT01931566] with an adjudicated diagnosis of mild cognitive~     impairment (MCI) due to Alzheimer's Disease (AD).~   "
97969|NCT02284893|"~     A combination of saxagliptin and dapagliflozin added concurrently to metformin in combination~     with diet and exercise is superior to sitagliptin added to metformin in combination with diet~     and exercise in reducing mean HbA1c over a treatment period of 26 weeks.~   "
97970|NCT02284880|"~     Phase I, two-centre, open-label, randomized, gender-balanced, single-dose, laboratory~     blinded, two-period, two-sequence, crossover study in 2 groups of 20 healthy male and female~     subjects, to demonstrate the bioequivalence (BE) between two active product ingredient (API)~     sources of eslicarbazepine acetate (ESL)~   "
97971|NCT02284867|"~     Research question:~      Population of study: women diagnosed as term pregnancy in labor (control) and the other group~     diagnosed as preterm labor (cases).~      Intervention: measuring uterine natural killer cells . Outcome: uterine natural killer cells~     has a role in initiation of preterm labor.~      Research hypothesis:~      • Are uterine Natural Killer cells involved in the initiation of preterm labor ?~      Medical Application:~      • Possibility of prediction of preterm labor by assessment of Natural killer cells as well as~     preventing preterm labor by suppressing their activity .~   "
97972|NCT02284854|"~     Open-label study in two parallel groups of 20 healthy subjects each. Group A assessed the~     effect of CBZ on ESL pharmacokinetics, and Group B assessed the effect of ESL on CBZ~     pharmacokinetics.~   "
97973|NCT02284841|"~     This study evaluates the efficacy of Hilotherm therapy on the incidence of swelling and pain~     following the surgical removal of lower wisdom teeth. All participants will have two lower~     wisdom teeth removed, with the Hilotherm cooling face mask only applied to one side of the~     patients' face for 60 minutes post-operatively, thus the patient being their own control.~   "
97974|NCT02284828|"~     Single-blind, single-centre, fixed-order study to evaluate the PD effects of a single oral~     dose and multiple oral doses of ESL (BIA 2-093) in healthy volunteers.~   "
97986|NCT02284672|"~     Propofol frequently used as an inducting medication for insertion Laryngeal mask airway(LMA).~     But propofol alone can be not sufficient for inhibiting upper airway reflex and also result~     in cardiovascular suppression under enough amount. Dexmedetomidine is a selective alplh2~     receptor agonist with analgesic and sedative effects but sparing respiratory function.~     Therefore propofol combined with dexmedetomidine induction could be more effective in~     preserve respiration under same condition for LMA insertion than propofol alone. In this~     study, the investigators investigate the clinical dose of propofol for LMA insertion with~     premedication of dexmedetomidine, and evaluate the effect of dexmedetomidine.~   "
97975|NCT02284815|"~     Type 1 diabetes (T1D) emerge when the auto-immune destruction exceeds the beta cell's~     regenerative capacity. The patients' beta-cell capacity increases shortly after onset when~     glucotoxicity decreases after the start of insulin therapy. Children have fewer beta cells~     and therefore shorter remission; but the expansion potential is larger the younger the child~     is. The problem with the majority of intervention studies is the many and serious side~     effects, or a quite marginal effect on the residual beta-cell function. However, in animals~     that had received gluten-free diet, the T1D incidence fell from 61% to only 6%. Gluten-free~     diet increases the number of regulatory T cells in Peyer's patches, affect the composition of~     intestinal microflora and modify the balance between pro and anti-inflammatory cytokines in T~     cells. Therefore, the aim of our study is to prolong the remission phase by introducing a~     gluten-free diet intervention to children at T1D onset.~   "
97976|NCT02284802|"~     Confocal endomicroscopy is an emerging technique that allows in vivo imaging of cells and~     tissue structures of the gastrointestinal mucosa, with a magnification of about 1000 times,~     guiding optical biopsies in real time. Confocal endomicroscopy represents technique that~     combines conventional white light image with the confocal microscope probe, thereby allowing~     examination of the surface epithelium in vivo and histological diagnosis during endoscopy.~     Among the applications already established for its use, stand out diagnosis of Barrett's~     esophagus, gastric atrophy and intestinal metaplasia, celiac disease, differentiation of~     hyperplastic adenomatous polyps of the colon, microscopic colitis and follow-up of patients~     with inflammatory disease, reducing the need for endoscopic biopsies. The CLE can still~     detect molecular changes effectively improving the endoscopic diagnosis. This pilot project~     consists of 07 subprojects which the technology of confocal endomicroscopia will be evaluated~     and compared with the histological results of biopsy or surgical specimens:~      1. confocal endomicroscopy for the diagnosis of high-grade dysplasia and superficial~     esophageal adenocarcinoma in patients with Barrett's esophagus 2 Diagnosis of superficial~     esophageal squamous cell carcinoma in patients with head and neck cancer by confocal~     endomicroscopy 3 Detect the presence of premalignant lesions in the gastric stump in patients~     with reflux alkaline gastritis after partial gastrectomy 4. detect lesions in the gastric~     mucosa of patients with familial history of gastric cancer 5 Biliary Strictures: differential~     diagnosis by confocal endomicroscopia 6 confocal Endomicroscopy of cystic neoplasms of the~     pancreas 7 Contribution of confocal endomicroscopy for the differential diagnosis of~     colorectal polyps The project aims to deploy the structure of the Confocal endomicroscopy~     Endoscopy ICESP, for performing in vivo histological examinations of the digestive tract,~     biliary tract and pancreas. All research groups involved in the early detection of tumors of~     the esophagus, stomach, biliary tract, pancreas, colon and rectum may benefit from the~     implementation of this methodology.~   "
97977|NCT02284789|"~     To obtain evidence of content validity and reliability of the Colorado Adult Joint Assessment~     Scale (CAJAS), a clinician-reported outcome (ClinRO) measure, as adapted for use in a~     population of adults with moderate to severe hemophilia A treated with coagulation factor~     VIII (FVIII) therapy as secondary prophylaxis or episodic treatment.~   "
97978|NCT02284776|"~     The goal of this study is to assess the effect of a therapeutic education program in addition~     of a hydrotherapeutic cure on obese patients.~      The therapeutic education program at the thermal baths of Brides-les-Bains is composed of a~     dietary follow-up, a physical activities program, working group.~   "
97979|NCT02284763|"~     The aim of this study was to investigate the relationship between the end-tidal carbon~     dioxide (EtCO2) and cerebral oxygen saturation (rSO2) and to identify the covariates in the~     pharmacodynamic relationship between EtCO2 and rSO2.~   "
97980|NCT02284750|"~     The purpose of this study is to establish the optimal strategy for stenting in coronary~     bifurcation lesion.~   "
97981|NCT02284737|"~     Pulmonary arterial hypertension (PAH) is characterized by premature death mainly because of~     progressive and severe right ventricular failure. Target drugs are reported to be associated~     with significant improvement of clinical outcome for PAH patients. However, previous studies~     using those target drugs focused on the change of 6-minute walk distance (6MWD) and or~     hemodynamic responses. As 6MWD has weak correlation with clinical outcome (time to clinical~     worsening, TTCW), benefits from target drugs for PAH patients are not clear. We previously~     reported the safety and efficacy of pulmonary artery denervation (PADN) for treatment of PAH~     patients who were unresponsive to target drugs. Hence, we design the randomized study to~     identify the effect of PADN on PAH.~   "
97982|NCT02284724|"~     To examine for differences in contraction thickness of the transversus abdominis muscle in~     symptomatic subjects with mechanical lower back pain following the application of dry~     needling to the lumbar multifidus muscles.~   "
97983|NCT02284711|"~     Epithelial cancer of the ovaries is the most severe form of gynecologic cancer; a significant~     proportion of ovarian cancers originate from the Fallopian tube. Guidelines therefore now~     recommend systematically associating prophylactic salpingectomy to benign hysterectomy. The~     principal objective of the present study is to assess the impact of salpingectomy on ovarian~     reserve by anti-Müllerian hormone (AMH) assay and calculating the Doppler index of vascular~     resistance in the ovarian vessels. The secondary objective is to compare ovarian reserve~     results between two coagulation techniques used in salpingectomy: bipolar electric energy~     versus ultrasound.~      The study design is single-center, prospective, before-and-after, with open randomization~     between two groups defined by coagulation technique.~   "
97984|NCT02284698|"~     A community-randomized trial comparing villages randomized to receive an intervention~     consisting of a trained community health volunteer who brings patients to the nearest Vision~     Centers or Primary Health Care Centers for treatment after diagnosing a corneal abrasion to~     control villages receiving no additional intervention. The primary outcome of corneal ulcer~     will be measured by baseline and annual population-based census performed in both~     intervention and control villages by masked examiners from baseline to 24 months. Each~     resident in the village will be asked about their ocular history and, if suspected of having~     a corneal ulcer, will be examined for evidence of a corneal opacity. Annual visits will~     occur, coinciding with the end of the harvest season. In villages randomized to intervention,~     an active promotion campaign will be undertaken to urge residents to notify the village eye~     health worker within 24 hours of ocular trauma. In control villages, abrasions and ulcers~     will be treated if they present to a clinic or are found during the annual monitoring visits,~     but active promotion of corneal abrasion care will not be offered.~   "
97985|NCT02284685|"~     Eating disorders (EDs) have the highest rate of mortality of any mental illness. On U.S.~     college campuses, an estimated 80% students with clinically significant ED symptoms do not~     receive treatment. There are likely more than one million students whose EDs go untreated in~     any given year. Left untreated EDs typically become more severe and refractory to treatment.~     Given the impact of EDs on mental and physical health and the connection therein with social,~     academic, and economic outcomes, an effective intervention to increase rates of treatment~     utilization would have broad societal effects extending well beyond the campus setting. This~     study is an online intervention designed to identify and increase help-seeking among~     undergraduates with previously undiagnosed/untreated EDs.~   "
97989|NCT02284633|"~     In non-small celled lung cancer (NSCLC) 10-15% of the patients harbor a mutation in the~     tumor's epidermal growth factor receptor (EGFR M+). This receptor is the target for treatment~     with erlotinib. Identification of EGFR M+ is done on a biopsy, which can be difficult to~     retrieve. A new blood based test identifies EGFR M+ in plasma, which makes it possible to~     monitor the level of EGFR M+ in the patient's blood during treatment. This enables both a~     closer monitoring of the treatment with erlotinib and a closer study of the resistance~     mechanisms that almost inevitably develop during treatment. A pilot study demonstrated that~     the quantity of EGFR M+ in plasma correlates to the response to treatment and might be used~     to predict disease progression.~      Patients with disseminated EGFR M+ NSCLC referred to a participating oncology department may~     be enrolled in the project. The investigators expect to include 200 patients over a two-year~     period. Patients will receive standard lines of treatment and follow up. Standard 1st line~     treatment for these patients is erlotinib. A biopsy and blood sample will be retrieved before~     treatment with is initiated. The patient will be monitored prospectively with blood samples~     every 3rd-6th week both during erlotinib treatment, subsequent lines of treatment and~     treatment intermissions. The blood samples are analyzed for subtypes of EGFR M+ both~     sensitizing mutations and mutations known to drive resistance to erlotinib treatment. In the~     event of occurring resistance mutations or unexpected increase in quantity of sensitizing~     mutations clinical action will be taken; initially in the form of additional scans searching~     for signs of disease progression. Clinical data will be retrieved from the patient's medical~     journal. Patients are followed until death or at least 24 months after inclusion. Any excess~     biological material will be stored for up to 15 years in a bio bank for future research~     purposes.~      We expect our results to validate the use of EGFR M+ detection and quantification via blood~     samples in a clinically relevant setting. The investigators expect earlier identification of~     disease progression to allow more cases of local treatment thus - hopefully - increasing the~     progression free survival. Continued blood monitoring in subsequent lines of treatment and~     treatment intermissions will add to our knowledge of the nature of EGFR M+ NSCLC. The~     sampling of biological material allows us to further investigate the biology of resistance.~   "
97990|NCT02284620|"~     Post-operative pain after total knee arthroplasty is usually severe and impair the functional~     recovery of operated joints.The purpose of this study is to determine whether post-operative~     continuous femoral nerve block analgesia is superior to local wound infiltration combined~     with intravenous patient controlled analgesia in improving joint function and reducing the~     incidence of chronic post-surgical pain (CPSP).~   "
97991|NCT02284607|"~     This Phase 1, randomized, double-blind, placebo-controlled study will evaluate the safety,~     tolerability and pharmacokinetics of two, single intravenous (IV) high doses of MHAA4549A as~     compared to placebo when administered to healthy volunteers.~   "
97992|NCT02284594|"~     Influenza infection leads to on average 3000-49,0000 deaths and 150,000 hospitalizations~     annually. While vaccination is the cornerstone of preventing influenza infection, vaccination~     coverage in adults is low. Latino adults have the lowest coverage rates. Text message~     reminders have been used successfully for improving influenza vaccination for children. This~     study will assess the use of text messaging to improve influenza vaccination coverage rates~     in a largely minority, publicly insured adult population. We will also assess if the patient~     having received a text message makes the patient more likely to accept vaccination when their~     provider has received in electronic alert regarding need for influenza vaccination in the~     electronic health record.~   "
97993|NCT02284581|"~     Breast cancer is the most common cancer in many countries: in Italy about 48.000 new breast~     cancers are diagnosed every year and, despite improvements in diagnosis and therapy, about~     13.000 women die every year for this disease . About 6-7% of breast cancer patients are~     metastatic at diagnosis , while the majority of patients with stage IV has a previous history~     of breast cancer that has already been treated. According to various prognostic factors~     (tumor size, lymph nodes involvement, grading, hormone receptors status, HER-2 status), in~     the worst-case scenario, more than 30% of node-negative breast cancer patients and more than~     70% of node-positive patients relapse2.~      The evolution of metastatic breast cancer has changed considerably in the last years with the~     approval of new drugs. In fact, already in 2003 Giordano et al showed that the prognosis of~     metastatic breast cancer patients was improved significantly from 1970's to 2000 with a~     median survival of 15 months in the early 1970's compared with 60 months in the last 1990's.~      This significant survival gain was obtained with introduction of new drugs as hormonal,~     chemotherapeutic and biological agents. The greater availability of drugs has led to an~     increase in number of lines of treatment receiving by metastatic breast cancer patients.~     However, there are few published data on actual duration of metastatic breast cancer~     treatments. Moreover, there is no evidence to support a real impact on survival of treatments~     beyond the second-third line.~      Recently, a retrospective analysis of about 199 metastatic breast cancer patients treated~     with chemotherapy showed that tumor subtype is associated with the duration and number of~     lines of chemotherapy (for example HER positive versus triple-negative patients) .~   "
97994|NCT02284568|"~     This Phase 2 study is intended to serve as a proof of concept for potential treatment with~     laquinimod in patients with PPMS. The study is also aimed at evaluating 2 doses of laquinimod~     in this population.~   "
97995|NCT02284555|"~     This study will assess the nasal eradication of SA in healthy subjects following treatment~     with mupirocin 2% (Bactroban 2% Nasal Ointment) twice daily for 5 days, by means of a broth~     enriched culture microbial assay. The sensitivities of broth enrichment and plating assay~     methods will be compared. The safety and tolerability of Bactroban 2% Nasal Ointment will~     also be assessed.~   "
97996|NCT02284542|"~     The primary objective is to demonstrate the safety and efficacy of a non-awake implantation~     method (EMG neuromonitoring) of a SCS paddle lead as compared to an awake implantation method~     (with local anesthesia and patient feedback).This is a post-market, prospective, multicenter,~     parallel designed, non-randomized, non-blinded, 6-month study. A minimum of 50 patients will~     be implanted from up to 4 active sites, coordinated by a single lead investigator.~      Patients who have had a successful SCS trial and are indicated for permanent implantation~     will be approached to participate in this study prior to permanent implantation. Patients~     will be recruited and enrolled by physicians at any one of the involved sites. Each~     Investigator will only use one method (awake or non-awake) according to his/her typical~     practice. Patients will receive treatment from their enrolling physician.~   "
97997|NCT02284529|"~     Open- Label, Single Arm Study. To evaluate the safety profile of Orectalip® (oxaliplatin),~     fluorouracil and leucovorin as adjuvant therapy in the treatment of high-risk stage-Ⅱ~     colorectal cancer.~      Primary end point:To evaluate the incidence of grade 0-3 neurosensory symptoms (paresthesia)~     in the end of study.~      Other end points:The incidence of Grade 3 or 4 neutropenia, thrombocytopenia, anemia, nausea,~     diarrhea vomiting over the 12 weeks.~      Safety will be evaluated including vital signs are recorded at all visits.~   "
97998|NCT02284516|"~     Evaluate the efficacy and safety of Lifitegrast in subjects with dry eye disease and a recent~     history of artificial tear use.~   "
97999|NCT02284503|"~     This is a 30-day, randomized, open-label, 3-arm, parallel-group, multicenter study exploring~     efficacy of intensive rosuvastatin treatment peri-PCI in Chinese patients with NSTE-ACS.~   "
98001|NCT02284477|"~     -  Phthalate is an endocrine disrupting chemical, which works as an anti-androgenic agent.~        -  Phthalate is mainly used as PVC plasticizer and easily found in commonly used products~          such as electronic device, paint, lubricant, surfactant, medical supplies, spray etc.~          Especially, PVC blood bag used for blood transfusion have been reported to have high~          level of phthalate concentration.~        -  Previous studies reported that urinary concentration of phthalate metabolites and HOMA~          (Homeostatic model assessment, indicator of insulin resistance) has positive~          association.~        -  Previous studies also reported negative associations between urinary phthalate~          concentration and pulmonary function.~        -  Exposure to phthalates occurs mainly through oral route. Food wrapping with phthalate~          containing package material is expected to be one of the major contributor for phthalate~          exposure.~        -  In this present trial, the investigators are to examine whether increased phthalate~          exposure by consuming beverage stored in PVC containing packing materials actually~          effect insulin resistance, pulmonary function and epigenetic feature.~        -  For this aim, the investigators will conduct a cross-over trial.~   "
98002|NCT02284464|"~     Steroids are one of the pillars of immunosuppression for kidney transplant patients but their~     use is associated with a high rate of complications. Withdrawal of steroids reduces some~     metabolic and cardiovascular complications, but it may increase the risk of acute rejection.~     However, little is known about whether steroid withdrawal is associated with the generation~     of anti-HLA donor-specific antibodies (DSA) and the relation between DSA and clinical and~     histological data. The aim of this study is to compare the incidence of de novo anti-HLA DSA~     in stable kidney transplant patients after withdrawing the steroids 3 months after the~     transplantation as compared with patients who continue with steroids. The hypothesis is that~     steroid withdrawal will increase the presence of de novo anti-HLA DSA in stable kidney~     transplant patients~   "
98003|NCT02284451|"~     The Centers for Disease Control and Prevention (CDC) recommends that all patients should~     receive information about HIV/AIDS and HIV testing orally or in writing at every HIV testing~     encounter. However, for busy emergency departments (EDs), delivering information orally is a~     barrier to HIV testing, and written brochures likely are not useful for those with lower~     health or general literacy. Videos might be as or more efficacious than orally-delivered~     information in improving HIV/AIDS and HIV testing knowledge, particularly for those with~     lower health literacy skills. However, the resources required to show videos might limit~     their use in EDs. Pictorial brochures are a promising alternative, but are of unknown~     efficacy.~      The objectives of this study are to: (1) determine if HIV/AIDS and HIV testing information~     should be delivered by a video or pictorial brochure to emergency department (ED) patients to~     improve short-term (in the ED) knowledge about HIV/AIDS and HIV testing; (2) determine if~     longer-term retention (over 12 months) of HIV/AIDS and HIV testing knowledge is greater for~     those who watch a video or review a pictorial brochure; (3) determine if short-term~     improvement and longer-term retention in HIV/AIDS and HIV testing knowledge is better after~     watching a video or reviewing a pictorial brochure for those with lower health literacy, and~     if improvement and retention also varies by language spoken (English or Spanish); and (4) if~     willingness to be tested again in one year is greater for those who watch the video or review~     the pictorial brochure, and if this willingness also varies by health literacy level and~     language spoken.~   "
98004|NCT02284438|"~     Three endotracheal tubes (ETTs) with different surfaces properties will be studied regarding~     formation and structure of the biofilm formed on those ETTs.~      Cultures from oropharynx and tracheal secretions as well as pieces of the ETT will be~     examined.~      Findings from electron microscopy (EM) and microbiology will be analyzed and compared in~     respect to the three materials.~   "
98005|NCT02284425|"~     This is a phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety~     and tolerability of REGN1193 in patients with Type 2 Diabetes Mellitus.~   "
98006|NCT02284412|"~     The use of neuromuscular blocking agents (NMBAs) is still associated with postoperative~     pulmonary complications. The investigators rely on acceleromyography (AMG) of a peripheral~     nerve/muscle to assess the patients' breathing capability at the end of surgery. It is~     possible that respiratory complications after surgery (e.g. desaturation and atelectasis) are~     related to the lack of diaphragm activity.~      A previous trial by our study group links the use of sugammadex, a novel selective relaxant~     binding agent (SRBA) for reversal of neuromuscular blockade, to an increase in diaphragm~     electrical activity, compared to reversal with neostigmine. Our hypothesis is that by making~     nicotinergic acetylcholine receptors free from rocuronium in the diaphragmatic neuromuscular~     junctions, instead of increasing the amount of acetylcholine (like neostigmine does),~     sugammadex will result in a better neuromuscular coupling. This may have its subsequent~     effects on the central control of breathing, influencing the balance between intercostal and~     diaphragm activity.~      The investigators now propose a study in rats, where the investigators will use Functional~     Respiratory Imaging (FRI, property of FluidDA n.v., Groeningenlei 132, B-2550 Kontich) to~     assess regional lung ventilation after sugammadex, neostigmine or spontaneous reversal. The~     images obtained through micro-CT scans allow us to accurately reconstruct airway morphology~     in the free-breathing rat. It will provide us with new insights into breathing physiology~     after reversal of neuromuscular blockade.~   "
98007|NCT02284399|"~     Information on pregnant women undergoing non-invasive prenatal testing (NIPT) at one of the~     Obstetrix Medical Groups Outpatient Centers between January 2012 and June 2014 will be~     retrospectively gathered and an analysis of the impact and prevalence of NIPT. This will be~     compared to a control group of pregnant women in those same practices undergoing prenatal~     testing during the months of January 2010-July 2010.~   "
98008|NCT02284386|"~     This is a Phase 4, multicenter, open-label study designed to characterize the pharmacokinetic~     (PK) profile of total bupivacaine in approximately 15 adult subjects undergoing primary~     unilateral total knee arthroplasty (TKA) with bupivacaine hydrochloride (HCl) spinal nerve~     block (SNB) and EXPAREL local infiltration into the surgical site.~   "
98009|NCT02284373|"~     The purpose of this study is to evaluate the effect of pneumatic compression in improving~     symptoms, quality of life and wound healing in patients with venous ulcers and/or lymphedema.~   "
98010|NCT02284360|"~     This is a prospective, single center, randomized, double-blinded, placebo-controlled,~     exploratory phase I clinical trial in healthy male subjects to investigate the safety and~     tolerability of the cytokine based gel APOSEC™. The proof of safety and tolerability of~     APOSEC™ is the primary objective. The secondary objective is to measure the extent of wound~     healing of APOSEC™.~   "
98011|NCT02284347|"~     This is a prospective, non-randomized, single-arm study designed to assess the safety and~     device performance of the NuVent navigation-guided balloon system for use in subjects with~     scarred, granulated, or previously surgically altered tissue (revision).~   "
98012|NCT02284334|"~     The investigators are conducting a research study on nutrition in mitochondrial disease. The~     investigators are interested in the kind of carbohydrates that people eat. Carbohydrates are~     an important source of energy. Certain kinds of carbohydrates tend to raise blood sugar more~     in healthy people, and others tend to raise blood sugar less in healthy people. The~     investigators would like to know if by eating the right type of carbohydrate, people with~     mitochondrial disease can avoid high lactate levels, high blood sugar levels, and, later, low~     blood sugars.~      In this study, this question will be answered by finding out how people with mitochondrial~     disease respond to two different test meals containing different kinds of carbohydrates.~     Neither participants nor the investigators will know which kind of test meal participants are~     eating.~   "
98013|NCT02284308|"~     There is no detailed information available on benefits and harms of intensified treatment~     with concurrent RCHT among a subpopulation of elderly patients. Reliable tools are needed to~     distinguish the subgroup of fit patients from frail patients.~   "
98014|NCT02284295|"~     The objective of this study is to investigate molecular, cytological and genetic features of~     occupational chronic obstructive pulmonary disease (COPD) in conditions of different~     occupational exposures. In order to achieve this goal serum pro-inflammatory cytokines and~     standard inflammation markers level, hemostasis, cytological analysis of bronchoalveolar~     lavage fluid and association of single nucleotide polymorphisms (SNPs) rs1800470 transforming~     growing factor β1 (TGF β1) gene, rs1828591 hedgehog interacting protein (HHIP) gene,~     rs4129267 interleukin 6 receptor (IL-6R) gene, rs1051730 nicotinic acetylcholine receptor 3~     (CHRNA3) gene with COPD in subjects exposed to silica dust and in those exposed to polycyclic~     aromatic hydrocarbons exhaust will be investigated. The relationship between genotype and~     phenotype characteristics, such as an inflammation activity, assessed by C-reactive protein~     (hsCRP) and tumor necrosis factor alpha (TNF α) serum concentration, in different~     occupational COPD groups will be studied. The hypothesis is that the mechanisms underlying~     disease development and progression are different due to environmental risk factor that~     reflex in differs in disease attributes - molecular biomarkers, cytology results and genetic~     susceptibility between COPD due to dust, COPD due to chemicals and COPD in smokers therefore~     COPD can be subdivided into ecological phenotypes according to environmental risk factor.~   "
98015|NCT02284282|"~     The objective of this study is to determine if a single spinal shot of morphine can decrease~     post-operative opioid-use, and thereby decrease opioid side-effects and lead to a quicker~     recovery after surgery.~   "
98016|NCT02284269|"~     The purpose of this study is to integrate the post-marketing surveillances data (Specified~     use-results surveys on long-term treatment) of the 6 SGLT2 inhibitors approved or applied in~     Japan and to evaluate the safety and efficacy of long-term use of each under actual clinical~     practice conditions.~      In each post-marketing surveillance, 3000 patients who complete a 3 years treatment are~     enrolled. A total of 18000 patients are assessed in the meta-analysis.~   "
98017|NCT02284256|"~     The primary objective of the study is to demonstrate the non-inferiority or superiority of~     Fibrocaps plus gelatin sponge compared to Tachosil when control of mild to moderate bleeding~     with conventional surgical techniques is ineffective or impractical.~   "
98018|NCT02284243|"~     The primary objective of this study is to evaluate the analgesic efficacy, on Post-Operative~     Day (POD) 1, of DEX-IN compared with placebo, using the summed pain intensity difference over~     the first 48 hours (SPID48) in subjects with acute moderate to severe pain following~     unilateral bunionectomy.~   "
98019|NCT02284230|"~     The present study will examine the effects of liraglutide treatment during 26 weeks on~     several cardiovascular risk factors in patients with prediabetes and end-stage renal disease~     (ESRD). The primary objective is to determine the efficacy of the treatment on glucose~     tolerance evaluated during a 3h 75g-oral glucose tolerance test (OGTT). Secondary objectives~     include various clinical and biochemical cardiovascular and safety parameters.~      We hypothesise that treatment with liraglutide can improve glucose tolerance in prediabetic~     patients with ESRD by normalizing plasma glucose excursions during an OGTT and ameliorate~     other cardiovascular risk factors.~   "
98020|NCT02284217|"~     Invasive intracranial pressure (ICP) monitoring is highly effective, but involves risks.~     HS-1000 measures ICP non-invasively by assessing the acoustic properties of the patient's~     head. HS-1000 device, a proprietary new non-invasive ICP monitor, is expected to safely and~     accurately monitor ICP with minimal discomfort to patients, and provide information about~     normal or elevated ICP levels to the physicians.~      The study objective is to compare the accuracy and safety profile of HS-1000, a non-invasive~     ICP monitor, to invasive ICP monitoring via an external ventricular drain (EVD)~   "
98036|NCT02284009|"~     This is a Phase II, randomized, double-blind, parallel group, placebo controlled, multicentre~     study of 52 weeks treatment duration. The primary objective is to evaluate the efficacy(on~     endogenous insulin secretion), safety and tolerability of weekly albiglutide (a glucagon-like~     peptide-1 receptor (GLP-1R) agonist) versus placebo when added to insulin therapy in subjects~     with new-onset type 1 diabetes mellitus (NOT1DM) and residual insulin production..~     Approximately 68 eligible subjects will be randomised in a 3:1 ratio such that 51 subjects~     receive albiglutide 30 milligram (mg) once weekly (with increase to 50 mg once weekly at Week~     6 if the 30-mg weekly dose is tolerated) added-on to insulin therapy and 17 subjects receive~     placebo once weekly added-on to insulin therapy. The total duration of a subject's~     participation will be approximately 72 weeks (up to 8 weeks of Screening, 52 weeks of~     treatment and 12 weeks of Post-treatment Follow-up)~   "
98532|NCT02277522|"~     Pilot open-label study to estimate the feasibility, safety and efficacy of intravenously~     administered, RNA electroporated autologous T cells expressing CD19 chimeric antigen~     receptors expressing tandem TCR and 4-1BB (TCR /4-1BB) costimulatory domains (referred to as~     RNA CART19) in Hodgkin Lymphoma (HL) patients.~   "
98021|NCT02284204|"~     There is still extensive debate on the best method of controlling the behavior of preschool~     children during dental treatment. Protective stabilization, moderate sedation and general~     anesthesia are advanced behavior control techniques indicated for the dental treatment of~     early childhood caries and offer advantages and disadvantages during the procedure or~     immediately after. Many children with early childhood caries require invasive dental~     treatment. According to the final report of a large epidemiological survey on the oral~     condition of Brazilians, five-year-old children had an average of 2.43 primary teeth with~     caries and fewer than 20% of these had been treated in 2010. This disease also remains a~     public health problem in most developed countries; 19.5% of 2-5-year-old American children~     have untreated cavities.~      There is, however, a lack of the ideal sedative. Such drugs must, on the one hand, control~     the behavior of integral form, provide amnesia, minimizing physical discomfort, distress and~     pain, and, on the other, safeguard security, with minimal effect on the cardio-respiratory~     function, minimizing the occurrence of adverse events, as well as allowing the return of the~     patient to a State that allows high safely. The investigators thus performed this prospective~     study with the aim to assess the occurrence of adverse events during dental treatment and in~     the first 24 hours after sedation with midazolam, ketamine and sevoflurane in children aged~     four to six years. Our hypothesis was that no differences in adverse events among different~     association of drugs could be found.~   "
98022|NCT02284191|"~     This study aims to investigate the effect of early CTCA in patients with suspected or~     confirmed Acute Coronary Syndrome (ACS) presenting to the Emergency Department (ED) or~     Medical Assessment Unit (MAU), upon interventions, event rates and health care costs in a~     pragmatic clinical trial and economic evaluation up to 1 year after the trial intervention.~     The primary objective will be to investigate the effect of the intervention on the proportion~     of patients with all-cause death or recurrent non-fatal type 1 or type 4b myocardial~     infarction (MI) at one year.~   "
98023|NCT02284178|"~     Insertion of a breathing tube to enable treatment with mechanical ventilation (respirator) is~     often associated with complications, such as infection and lung injury. Leakage of secretions~     around the breathing tube (microaspiration) is a major factor leading to complications. The~     investigators propose that a standardized, enhanced oral suction protocol will be effective~     in reducing microaspiration and harms associated with mechanical ventilation. The~     investigators hypothesize that those randomized to the enhanced oral suction protocol will~     have less microaspiration and other ventilator-associated conditions than those in the usual~     care, standard suction group.~   "
98024|NCT02284165|"~     Retrospective analysis of Get With the Guidelines-Stroke data linked with Medicare claims and~     the AVAIL longitudinal data sets to assess patterns, predictors, and outcomes associated with~     the use of rehabilitation services following hospitalization for ischemic stroke. Primary~     completion defined as the end of primary analyses, consistent with the end of the PCORI Cycle~     I grant period. Study completion defined as acceptance of final research report and lay~     abstract by PCORI.~   "
98025|NCT02284152|"~     In the present study, we tested a novel approach to understanding infant bottle-feeding~     interactions: experimentally manipulating bottle-feeding conditions to better understand~     maternal and infant influences on overfeeding, as well as individual differences in risk for~     overfeeding. Specifically, we observed mother-infant dyads during a typical, mother-led~     feeding, during which mothers were given no instruction regarding how or how much to feed~     their infants (hereafter referred to as a typical feeding [TF]), as well as during an~     infant-led (IL) feeding, wherein we minimized the mothers' influence on the feeding and~     ensured the feed was in response to the infants' hunger and fullness cues. Using this~     within-subject, objective, and experimental approach, the present study aimed to: 1) directly~     measure the extent to which overfeeding occurs during bottle-feeding and 2) describe the~     characteristics of infants and mothers that overfeed during bottle-feeding.~   "
98026|NCT02284139|"~     The efficacy of the epidermal growth factor receptor (EGFR) inhibitors have been demonstrated~     in patients with non-small cell lung cancer (NSCLC), pancreatic cancer (PC) and colorectal~     cancer (CRC). Dermatological reactions can cause significant physical and psycho-social~     discomfort to patients. In the present study, the investigators evaluated the effect of~     epidermal growth factor (EGF) ointment on EGFR inhibitor-related skin side effects (ERSEs).~   "
98027|NCT02284126|"~     This study is a collaboration between NYP-Columbia and NYP-Cornell that seeks to evaluate the~     use of topical vancomycin and its reduction on surgical site infection (SSI) in neurosurgical~     procedures. Adult patients undergoing neurosurgery at either institution will be eligible for~     participation in this randomized control trial. Patients randomized to the treatment group~     will receive 2g of vancomycin applied as a powder or paste to the wound site and/or bone~     flap. Subjects in the control group will receive the current standard of care without topical~     vancomycin. All subjects will undergo swabbing of the anterior nares and the surgical site~     prior to surgery, once 10-14 days following the operation and 90 days following the~     operation. The primary outcome measure will be surgical site infection, assessed daily~     throughout the hospital stay, at the first follow-up visit, and by telephone at 30 days.~     Secondary outcomes will include length of hospital stay, length of intensive care stay, rate~     of reoperation and patient mortality. In addition, systemic vancomycin levels will be~     assessed at 6 hours and 24 hours postoperatively in each patient. Patients who have an~     external ventricular drain in place will have vancomycin levels assessed daily. In patients~     who have cranial drains placed, vancomycin concentrations will be analyzed from daily in~     wound drainage. Skin and nasal flora will be analyzed to assess the impact of topical~     vancomycin on the patient microbiome. Although there has been a decrease in the incidence of~     infections following craniotomy secondary to prophylactic intravenous antibiotics, proper~     sterile techniques, and other interventions, SSIs continue to significantly impact morbidity,~     mortality, and cost burden. Although never studied in neurosurgical procedures other than~     instrumented spine, the application of topical vancomycin to the surgical site prior to wound~     closure has demonstrated a reduction in SSIs in spine, cardiac and ophthalmologic procedures.~     The benefits of using prophylactic vancomycin topically, as opposed to intravenously, include~     reduced systemic levels of the drug, and therefore, a decreased probability of adverse events~     related to the drug, such as inducing resistance among native flora. The investigators~     propose a randomized control trial to evaluate the effectiveness of topical vancomycin in~     reducing SSIs rates following neurosurgical procedures.~   "
98028|NCT02284113|"~     This study will evaluate the iovera° device in treating pain associated with total knee~     arthroplasty (TKA). This study will also assess if overall pain medication is reduced~     following TKA and will investigate the relationship between patients treated with the iovera°~     device and length of hospital stay, pain, patient satisfaction and improved rehabilitation.~   "
98048|NCT02283853|"~     The main objectives of Part 1 are as follows: To evaluate the safety, tolerability, and~     efficacy of BG00012 in pediatric subjects with RRMS, as compared with a disease-modifying~     treatment and to assess health outcomes and evolution of disability. The primary objective of~     Part 2 is to evaluate the long-term safety of BG00012 in subjects who completed Week 96 in~     Part 1 of Study 109MS306. The secondary objective of Part 2 is to describe the long-term MS~     outcomes of BG00012 in subjects who completed Week 96 in Part 1 of Study 109MS306.~   "
98029|NCT02284100|"~     The relationship between human beings and animals, especially dogs, has existed for thousands~     of years. Historically, animals have held an important role in this relationship as they~     provide company, stimulus and motivation. Animals are excellent company, since their~     visitation they do not discriminate or segregate any person, that is, they are free of~     prejudice.~      In spite of the long-lasting presence of companion animals in human life, the idea that~     interaction with animals may exert a positive effect on human health is rather recent.~      The American Veterinary Medical Association classifies therapeutic animal assisted~     interventions (AAI) into three categories: animal assisted activities (AAA) that utilize~     companion animals; animal assisted therapy (AAT) that utilizes therapy animals and service~     animal programs (SAP) that utilize service animals. AAT in particular, is a goal-directed~     intervention in which an animal that meets specific criteria is an integral part of the~     treatment process. AAT is technically defined as the use of trained animals by trained health~     professionals to facilitate specific, measurable goals for individual patients for whom there~     is documentation of progress .~      Interest in AAT has been fueled by studies supporting the many health benefits. AAT has~     proven a useful adjunct in a variety of settings including mental health facilities, nursing~     homes and hospitals where most studies have been performed with adult patients with variable~     interventions, goals, patient characteristic and patient needs. In these studies, AAT~     resulted in significant reductions in anxiety, agitation and fear. In children, AAT dogs~     decreased distress during painful medical procedures, promoted calmness in children with~     post-traumatic stress disorders and increased attention and positive behaviors in children~     with pervasive developmental disorders.~      Surgical procedures and hospitalization can be stressful for both children and their parents~     and they are associated with pain, helplessness, fear and boredom. AAT has been shown to~     facilitate a child's ability to cope with hospitalization, but to date, no studies on AAT~     benefits in pediatric surgery have been reported.~      The purpose of this study was to better understand the effects of an AAT program on~     neurological, cardiovascular and endocrinological responses to stress and pain in the~     immediate post-operative period in children undergoing surgical procedures.~   "
98030|NCT02284087|"~     Introduction The motor impairment of the upper extremity is the most common sequelae after~     ischemic stroke. Transcranial magnetic stimulation (TMS) is a promising non- invasive~     technique in the rehabilitation of motor deficits. However, its effect in post-stroke motor~     deficits remains moderate our days. To potentiate the effect of TMS, techniques called Paired~     Associative Stimulations (PAS) involving the integration of afferent sensory inputs at the~     level of the ipsilesional primary motor cortex were developed in healthy subjects. PAS~     techniques have shown a gain of corticospinal excitability by such phenomenon known as long~     Term Potentiation (LTP) and a gain of motor performance. The investigators would like to~     propose to evaluate two types of these techniques with a volley of visual afferents~     (visuomotor stimulation, V_PAS) or of cerebellar afferents (CER_PAS), because these two~     structures convey important information in the execution of the movement.~      Design Multicenter, randomized, study, 60 patients in 3 parallel groups (V_PAS, CER_PAS,~     control group with sham and sham V_PAS CER_PAS), 5 days of treatment, clinical assessment,~     electrophysiological and MRI before, immediately post- and second post-assessments (4 weeks).~      A group of 24 healthy subjects will undergo a parallel physiopathological study on the~     underlying mechanisms of cerebellar PAS~      Objectives Main objective: To determine whether (and how) Paired Associative Stimulation~     technique (PAS) induces cerebral reorganization in the primary motor cortex compared to the~     control group.~      Aim 2: Determine whether (and which) type of PAS is capable of inducing changes in motor~     performance of the upper limb paresis and duration Aim 3: Determine whether (and which) type~     of PAS is capable of inducing changes in excitability of the corticospinal tract and duration~     Aim 4: Determine how PAS techniques modify the functional connectivity during movement Aim 5:~     Determine if connectivity changes during induced movement correlate with clinical~     improvements Aim 6: Determine whether patients who benefit of a type of PAS have specific~     anatomical lesion characteristics (volume, afferent and efferent white matter fasciculi~     integrity)~   "
98031|NCT02284074|"~     The purpose of this study is to develop a nasal challenge model that causes a mild degree of~     inflammation, without causing any pain or symptoms, but that allows us to measure a variety~     of proteins in nasal secretions which causes inflammation in the nose. The nasal challenge~     model involves spraying the nostrils in the form of a fine mist with 4 different doses (1,~     10, 30 and 100µg per nostril) of lipopolysaccharide (LPS) including a placebo. LPS is a type~     of protein which has been carefully purified from the outer cell wall of certain bacteria, is~     sterile and does not contain live bacteria, and will not cause infection.~      The investigators will measure any inflammation in the nose by looking at cells collected by~     washing the inside of the nose (nasal lavage) and placing small strips of paper in the nasal~     cavity. The paper absorbs the nasal fluid and the chemicals produced during inflammation and~     can be extracted from the paper and analysed in the laboratory. The investigators will also~     be collecting a small amount of nasal epithelium taken by way of a nasal scrape; this is done~     by using a Rhinoprobe, a small plastic curette which is used to scrape a small piece of~     lining of the nose. The investigators hope that information obtained from this study will be~     used in future studies that will test new study drugs designed to treat diseases of the~     airways and lungs ( like asthma and chronic obstructive pulmonary disease (COPD) and hay~     fever.~   "
98032|NCT02284061|"~     Context: Sport and physical activity during and after cancer treatment can improve fitness~     and social inclusion in adults. In children, although early studies show interesting results,~     conclusive data are lacking. A preliminary evaluation conducted in a dozen children following~     a physical training program showed a significant improvement in endurance, muscle tone,~     overall self-esteem, sports skills and self-perceived strength. The investigators then want~     to evaluate the health of a group of children during treat cancer that physical activities~     adapted compared to children who did not practice.~      Objective: Measuring the impact of physical activity program on health of children and~     adolescents with cancer with improved physical, psychological health, social reintegration~     and reduced time hospitalization.~      Method and Design: The study plans to include 90 children from the pediatric hematology -~     oncology department of the La Timone CHU, aged 5-19 years with cancer, over a period of 18~     months.~      This is a randomized controlled open trial open with a stratified distribution. Children will~     be randomized between two arms - Arm A (Experimental - Immediate Program): the child follows~     the physical activity program for a period of 18 months, as soon as his medical condition~     permits. - Arm B (Control - Delayed Program): the child does not participate to the program~     during the first 6 months, and he joins the delayed program late after 6 months. Each child~     integrates the physical program for a period of one year.~      Regardless of the randomization arm, the child performs the initial tests, the intermediate~     tests at 6 and 12 months and final tests at 18 months. Follow-up physical testing will be~     performed at 3 and 9 months.~      The physical activity program includes a minimum of 30 days of activities per 6 months~     (4days/month and a long stay). The child practice between 2 to 4 hours of activity per day.~      The investigators aim at demonstrating a difference of 50 meters on the total walked distance~     during the endurance test in the experimental group as compared to the control group after 6~     months of program.~   "
98033|NCT02284048|"~     This study is undertaken to determine if ticagrelor augments adenosine-induced coronary flow~     reserve (CFR), ameliorates clinical symptomatology and exercise tolerance in patients with~     MVA~   "
98034|NCT02284035|"~     A pilot 24-week open-label, randomized, controlled clinical trial to assess the safety,~     tolerability and efficacy of dual therapy with Raltegravir/Lamivudine combination when~     replacing standard combination therapy in HIV-infected patients with prolonged virological~     suppression~   "
98035|NCT02284022|"~     the objective of this protocol is evaluate the safety and tolerance of a communication system~     for severely disable patients with myopathies. The system analyses the brain electric~     activity in real time and converts it into digital commands for a spelling device, which is~     refered to as the P300 speller in the scientific literature. The secondary objective is to~     compare the performance of such tool with a more traditional assistive technology for the~     communication of severely disabled patients : scanner systems.~   "
98049|NCT02283840|"~     Single center, randomized, single dose, laboratory-blinded, 2-period, 2-sequence, crossover~     design~   "
98050|NCT02283827|"~     Single centre, open-label, multiple doses, two parallel study groups each receiving two~     formulations in a one-sequence design~   "
98051|NCT02283814|"~     Single centre, open-label, multiple doses, one-sequence design study in two parallel groups~     of healthy volunteers~   "
98037|NCT02283996|"~     The purpose of this study is to identify individuals 18 or older who have diagnostic~     presentation of adhesive capsulitis and randomize them into two arms, distinguished by use of~     physical therapy and steroid injections compared with steroid injections followed by watchful~     waiting. This prospective study will be used to determine whether there is a significant~     impact on patient outcome and whether the additional financial burden is justified. There are~     no experimental interventions for this study. The use of physical therapy, oral and~     parenteral corticosteroids, and watchful waiting are offered following the standard of care~     for adhesive capsulitis. Our hypothesis is that patients will not have a significant~     difference in outcome between the two study arms. One group will undergo regular physical~     therapy with corticosteroid injections (Arm 1) and the other will have steroid injections~     during the inflammatory phase only and then be regularly observed (Arm 2). We also~     hypothesize there will be a significant financial burden associated with the PT arm that is~     not justified with the possibility of increased symptom reports in that arm.~   "
98038|NCT02283983|"~     For the specific patient population studied receiving 5-Fluorouracil, epirubicin and~     cyclophosphamide - Docetaxel sequence (cumulative dose <300 mg / m2), using a cryoprotection~     has never been assessed.~      The effectiveness of cryoprotection of onycholysis secondary to Docetaxel is not well~     established in this population (breast cancer in the adjuvant setting) and is based solely on~     a publication (Scotté) that does not contain the same therapeutic modalities (dose~     significantly higher). The few studies available have heterogeneous populations,~     nonrandomized, retrospective or with a small sample.~      By extension to what has been observed with higher cumulative doses of docetaxel, some teams~     offer mittens and booties chilled to their patients, a practice that is not the subject of a~     national consensus.~      The investigators wish to accurately assess the effectiveness of mittens and slippers~     chilled, their tolerance and their observance because of weak data on this specific~     population in the literature.~   "
98039|NCT02283970|"~     Prospective longitudinal study on four small groups of surgical patients affected by: BAV~     with isolated regurgitation, BAV associated with aorta dilatation, or both and BAV with~     isolated stenosis in over 60 year-old patients.~      The aim of the study is to select homogeneous small groups of surgical patients with the same~     subtype of BAV and same aortic behaviour and identify markers/predictors of~     favorable-unfavorable aortic wall evolution to evaluate if there is a BAV phenotype more~     likely to be considered at high risk for aortic degeneration.~   "
98040|NCT02283957|"~     Study 4975-MN-202 is a double-blind, placebo-controlled, parallel group, single-injection~     study in which subjects will be randomized to receive three doses of CNTX-4975 or placebo~     injected into the intermetatarsal space around a Morton's neuroma. The injection of study~     medication will be administered by ultrasound-guided needle placement following ankle block~     anesthesia. The study staff will telephone subjects at Week 1 postinjection and subjects will~     return to the clinic postinjection at Weeks 2, 4, 8, and 12 for study assessments.~   "
98041|NCT02283944|"~     The proposed project aims to develop novel electrochemotherapeutic treatment of glioblastoma~     multiforme (GBM). Standard treatment has limited effect on survival and quality of life.~     Electrochemotherapy is a novel and promising treatment, which has demonstrated convincing~     results in the treatment of various types of carcinoma. The treatment is based on a~     combination of electrical current stimulation of tumor cells and simultaneous administration~     of chemotherapeutic drugs. Electrochemotherapy works by inducing an electrical current~     between implanted electrodes in the tumor tissue, causing electroporation of the cancer cell~     membranes, and thereby increasing the cellular permeability and drug uptake.~     Electrochemotherapy has proven to be an efficient way of considerably increasing the potency~     of the chemotherapeutic drug bleomycin in malignant cells in skin tumors and carcinoma~     metastases, and thereby increasing cytotoxicity of the drug locally in the tumor tissue. This~     allows for treatment with lower doses of chemotherapeutic drugs and more defined, local area~     of effect, thus decreasing systemic effects. The investigators propose to use a novel~     non-invasive and safe technique called focused transcranial magnetic stimulation (focused~     TMS) to induce electrical current in the tumor tissue. TMS is a safe and widely implemented~     technology used to treat multiple neurological diseases such as pain, depression and stroke.~     Studies have shown that effective electroporation of cell membranes can be obtained using~     induction of electromagnetic fields in a cell suspension, and new focused TMS further enables~     focused treatment of selected brain regions without surgical intervention and, thereby~     focusing chemotherapeutic treatment to pathological tissue and avoiding surgery related brain~     tissue damage. Additionally, TMS transiently increases blood-brain barrier permeability,~     theoretically allowing increased uptake of chemotherapeutic drugs in the target area. This~     addresses a significant challenge in the treatment of brain cancer, as most cytotoxic drugs~     have fairly limited ability to pass the blood brain barrier.~      The intention of this research project is to investigate the therapeutic potential of focused~     TMS as an alternative non-invasive source of current induction and thereby means to treat~     several types of brain cancer with electrochemotherapy.~   "
98042|NCT02283931|"~     There is currently little information regarding the hemodynamic differences in uterine~     displacement techniques. Previous studies examining the hemodynamic effects of uterine~     displacement maneuvers have focused on incidence of hypotension and use of ephedrine.~      Noninvasive cardiac output monitoring (NICOM) and transthoracic echocardiography (TTE) are~     becoming popular techniques in anesthesiology because they can provide noninvasive, valid,~     and precise hemodynamic data.There has been no study specifically examining the hemodynamic~     differences between the uterine displacement techniques using NICOM or TTE. While all three~     uterine displacement techniques are recommended, whether one technique may maximize maternal~     cardiac output is currently unknown.~   "
98043|NCT02283918|"~     The primary objective of the study is to develop MS patient-matched healthy population norms~     for the Multiple Sclerosis Cognition Assessment Battery (MS-COG) that are representative of~     the United States (US), France, and Italy.~   "
98044|NCT02283905|"~     All patients with pulmonary blastomycosis requiring mechanical ventilation will have their~     blood concentrations measured for the antifungal drugs, amphotericin-B and voriconazole; as~     well as an analysis of the susceptibility of their infecting species of blastomyces. This~     information will then be analyzed relative to their rate of clinical recovery from this~     serious fungal infection.~   "
98045|NCT02283892|"~     This is a randomized clinical trial that evaluates the impact of using an internet-based~     checklist for systematic assessment of patients reporting respiratory complaints with the~     conventional assessment, without using the checklist.~   "
98046|NCT02283879|"~     The purpose of this study is to evaluate the safety and efficacy of human umbilical cord~     mesenchymal stem cell(hUC-MSC) for cerebral hemorrhage sequela.~   "
98047|NCT02283866|"~     Balanced anesthesia combining volatile anesthetics and opioids is commonly used in modern~     anesthesia. The purpose of this study is to compare two methods of administering desflurane,~     an volatile anesthetic during balanced anesthesia. The investigators hypothesized that~     administering desflurane at 1 MAC (minimum alveolar concentration) during balanced anesthesia~     will be more beneficial in terms of stability of the patient's vital signs and hypnotic depth~     than administering desflurane according to the patient's BIS (bispectral index) value.~   "
98054|NCT02283775|"~     Primary Objectives:~      Part A: To evaluate the safety and determine the recommended dose of SAR650984 in combination~     with pomalidomide (P) and dexamethasone (d), in patients with Relapsed/Refractory Multiple~     Myeloma (RRMM).~      Part B: To evaluate the feasibility of isatuximab administered from a fixed infusion volume~     in combination with Pd as assessed by occurrence of grade ≥3 infusion associated reactions~     (IAR).~      Secondary Objectives:~        -  To evaluate the infusion duration (Part B).~        -  To evaluate the safety profile of the combination with isatuximab administration from~          fixed volume (Part B).~        -  To evaluate immunogenicity of SAR650984 in combination with Pd (Part A and B).~        -  To evaluate the pharmacokinetics (PK) of SAR650984 and its effect on the PK of~          pomalidomide when administered in combination (Part A).~        -  To describe the efficacy of the combination of SAR650984 with Pd in terms of overall~          response rate and clinical benefit rate based on International Myeloma Working Group~          (IMWG) defined response criteria and the duration of response (Part A and B).~        -  To assess the relationship between clinical effects (adverse event [AE] and/or tumor~          response) and CD38 receptor density at baseline (Part A).~   "
98055|NCT02283762|"~     To investigate if Riociguat is effective in the treatment of systemic sclerosis~   "
98056|NCT02283749|"~     In this study patient's will receive the medicine Xofigo which is a radioactive drug that is~     FDA approved to treat prostate cancer that has spread to the bones. Xofigo has not previously~     been tested to treat lung cancer that has spread to the bones. Your doctors are studying the~     effects, good and bad, of Xofigo when used to treat lung cancer that has spread to the bones.~   "
98057|NCT02283736|"~     The aim of this randomized placebo- controlled clinical trial is to evaluate the effects of~     Lactobacillus rhamnosus SP1- containing probiotic tablets as an adjunct to scaling and root~     planning (SRP).~      Material and methods: Thirty six chronic periodontitis patients will be recruited and~     monitored clinically, immunologically and microbiologically at baseline, 3 and 6 months after~     therapy. All patients will receive scaling and root planning and randomly will be assigned~     over an experimental (SRP + probiotic, n=18) or control (SRP + placebo, n=18) group. The~     tablets will be used once per day during 3 months.~   "
98058|NCT02283723|"~     Health TAPESTRY is a delayed intervention pragmatic randomized control trial promoting~     interprofessional team collaboration, facilitating connection to the community through system~     navigation and trained community volunteers, enhancing communication and improving care~     through the use of technology to better understand and assist older adult patients in~     achieving their health goals and to enable them to have optimal aging.~   "
98059|NCT02283710|"~     This randomized double blind clinical trial was performed in patients with non-alcoholic~     fatty liver disease.They were randomly assigned to lifestyle modification alone or lifestyle~     modification plus Pentoxifylline groups. Liver function tests, metabolic profile and~     anthropometric measurements were checked at baseline and six months later.~   "
98060|NCT02283697|"~     High salt diet increases risk of development of hypertension. In hypertensive patients, low~     salt diet decreases blood pressure. Not surprisingly public health authorities endorse low~     salt diet in hypertensive patients. But, surprisingly, average salt intake among adults in~     Canada remains stubbornly high. Low effectiveness of fast counselling by physicians and~     nurses on dietary salt is partly the culprit. Methods used in successful clinical trials (eg.~     provision of meals, community cooking sessions, many hours of counselling by dieticians)~     cannot be used in routine clinical practice. Hence the investigators propose a study on a~     pragmatic dietary counselling method suitable for clinical practice.~      Hypertensive patients will be randomized to receive standard care (which includes counselling~     by the usual healthcare team, including doctors and nurses) or to receive additional~     counselling from a registered dietician. This counselling will include two components: a one~     hour counselling session, and 4, once-weekly telephone calls.~      Effectiveness of this counselling will be measured by checking sodium in the urine from a 24~     hour collection (which is a measure of dietary salt intake) at baseline and at 4 weeks. In~     addition, the investigators will also measure urinary sodium at 1 year, to assess if this~     effect of counselling persists over a longer time.~   "
98061|NCT02283684|"~     With a growing body of knowledge on the promising advancements and recent clinical data of~     the third generations of the Greenlight PVP/XPS, it seems to be a real contender in the world~     of MIS. Contenders of Greenlight laser technology includes bipolar as well as Holmium laser~     technology.~      In this study the investigators planned to test the Greenlight (532-nm) laser PVP using (XPS)~     180W system compared to bipolar electro-vaporization, in reduction of LUTS secondary to small~     to moderate sized BPH in a prospective randomized trial.~   "
98062|NCT02283671|"~     First in human study to assess the tolerability and safety profile of treatment with~     dendritic cell in patients with multiple sclerosis or neuromyelitis optica.~   "
98063|NCT02283658|"~     This pilot, phase II trial studies how well everolimus and letrozole work in treating~     patients with hormone receptor positive ovarian, fallopian tube, or primary peritoneal cavity~     cancer that has come back. Everolimus and letrozole may stop the growth of tumor cells by~     blocking some the enzymes needed for cell growth.~   "
98064|NCT02283645|"~     The purpose of this study is to determine efficacy and safety of 3% minoxidil lotion for~     chest hair enhancement.~   "
98065|NCT02283632|"~     This is a single site trial to assess metabolic effects in subjects after a Jejunal Diversion~     procedure was performed.~   "
98073|NCT02283528|"~     Patients who sustain a fracture of the lower jaw are typically treated by wiring the teeth~     together or using small titanium plates and screws to fix the fracture. With either technique~     the upper and lower teeth are held together to ensure that the fracture is held in the~     correct position during healing (for closed reduction) or while the plate and screws are~     applied (for open reduction).~      The teeth can be held together using Erich arch bars which are a type of braces that are~     temporarily wired to the existing teeth. These stay in place for 6 weeks until the fracture~     has healed even though the patient is able to open his mouth immediately after the surgery is~     complete. The alternative to the traditional Erich arch bars is a relatively new type of arch~     bar (Stryker Hybrid) that is screwed to the jaw bone rather than wired to the teeth. The~     purpose of this study is to compare the two types of arch bars in terms of the speed with~     which they can be applied as well as any difference in fracture healing~   "
98066|NCT02283619|"~     Purpose of the study:~      The goal of this study is to evaluate the relationship of electrocardiogram (ECG) findings~     with clinical outcomes in a cohort of patients with left bundle branch block (LBBB) who are~     being evaluated for acute coronary syndrome (ACS) in the Emergency Department (ED).~      Background and significance:~      The significance of specific ECG findings in patients with LBBB being evaluated for ACS has~     been inadequately studied, and this gap in knowledge is a barrier to optimal management of~     this population. Due to the speed, availability, low cost, and non-invasive nature of the~     ECG, it would be ideal to identify ECG characteristics that help to risk stratify these~     patients in order to inform clinical decision-making, reduce unnecessary invasive testing,~     and conserve resources.~      Methods:~      In this prospective observational study the investigators will identify a consecutive series~     of adult patients with LBBB presenting to the ED with suspicion of ACS. The investigators~     will collect data including demographics, cardiac risk factors, initial ECG measurements, lab~     and radiographic results, procedure results, and clinical outcomes such as 30-day death or~     myocardial infarction (MI). The investigators will analyze the data using a cohort study~     design to calculate odds ratios between ECG characteristics and the outcomes of interest.~   "
98067|NCT02283606|"~     The investigators aim to measure sonoelastographically the elasticity of the uterine cervix~     in pregnant patients at term before induction of labor and compare between patients with~     successful and failed inductions.~   "
98068|NCT02283593|"~     The purpose of this study is to observe and evaluate the use of a relapse prevention program~     over time among internet help-seekers. Participants are recruited via a nationally known~     portal for assisting anonymous individuals with changing their problematic alcohol use in a~     healthier direction (alkoholhjalpen.se). The intervention offered lasts 10 weeks and includes~     7 relapse prevention modules, with a three-week pause between the 6th and 7th modules.~     Baseline data are collected regarding substance use and psychosocial health and follow-up~     takes place 10 weeks after recruitment. The study is observational.~   "
98069|NCT02283580|"~     Recent work have shown that low load, high-repetitive single limb resistance training, if~     compared to a control, can increase limb muscle function and functional exercise capacity in~     patients with chronic obstructive pulmonary disease (COPD) while avoiding the occurrence of~     limiting exertional symptoms. However, no comparison to another exercise regimen have been~     performed. In addition neither the intramuscular nor the mechanism of this exercise regimen~     have been investigated and represents the aim of the proposed project. We will in a~     prospective, assessor-blind; block randomized controlled, parallel-group trial compare~     single-limb to two-limb low load, high-repetitive resistance training in patients with severe~     and very severe COPD~      The research hypothesizes are:~        -  that single-limb low-load high-repetitive resistance training will provide larger gain~          in the 6-min walking distance than two-limb low-load high- repetitive resistance~          training in patients with severe to very severe (stage III-IV) COPD.~        -  that eight weeks of single limb training should also be associated with larger~          physiological (increased muscle endurance, less muscle fatigue and deoxygenation) and~          structural (muscle protein synthesis, fiber-type distribution and capillarization)~          muscle adaptations to training, lower cardio- respiratory demand, as well a greater~          increase in health-related quality of life in comparison to two-limbs simultaneous~          training.~      We will also compare the groups at baseline to investigate the acute effects and mechanisms~     of single-limb to two-limb low load, high-repetitive resistance training, a comparison that~     also will include healthy matched controls.~      The research hypothesizes are:~        -  that involving a large muscle mass during exercise (e.g., two-limb low load,~          high-repetition resistance training) compared to involving a small muscle mass during~          training (e.g., single limb low load, high-repetition resistance training) would lead to~          larger restraints on the cardiorespiratory system in patients with severe to very severe~          COPD. Conversely, single limb interventions should produce less dyspnea and more muscle~          deoxygenation and fatigue than two-limb simultaneous exercise while healthy controls~          will be able to perform both legs/arms exercise without a central constraint, and no~          negative consequences on muscle fatigue or exercise stimulus.~   "
98070|NCT02283567|"~     The investigators aim to compare elasticity of the uterine cervix in singleton and twin~     pregnancies of similar gestational age.~   "
98071|NCT02283554|"~     ABSTRACT:~      Background: Platelet-rich fibrin (PRF) is a second-generation platelet concentrate which~     releases various growth factors that promote tissue regeneration. Metformin (MF), a member of~     biguanide group has been shown to facilitate osteoblast differentiation and thus may exhibit~     a favourable effect on alveolar bone . Current study was designed to evaluate the combined~     efficacy of PRF and 1% MF gel with open flap debridement (OFD) in treatment of intrabony~     defects in chronic periodontitis (CP) subjects.~      Methods: One hundred and twenty subjects with single defects were categorized into four~     treatment groups: OFD alone, OFD with PRF, OFD with 1% MF and OFD + PRF+1% MF. Clinical~     parameters like site specific plaque index (PI), modified sulcus bleeding index (mSBI),~     probing depth (PD), relative attachment level (RAL) and gingival marginal level (GML) were~     recorded at baseline before surgery and 9 months post-operatively. Percentage radiographic~     intra-bony defect depth reduction was evaluated using computer-aided software at baseline and~     9 months.~   "
98072|NCT02283541|"~     Falls are the leading cause of injury--‐related hospitalization and death in the elderly. As~     such, fear of falling (FOF) is common among senior populations and often leads to activity~     avoidance, social isolation, and reduced physical and mental health. Risk of falls is~     particularly concerning for individuals suffering from late life depression (LLD) as both~     depression and antidepressant treatment have been shown to be linked to gait impairments, a~     strong predictor of fall risk. Currently, our team is conducting a study to examine the~     effects of a non--‐pharmacological mind--‐body therapy commonly known as automatic~     self--‐transcending meditation (ASTM) on autonomic and mood--‐related symptoms of LLD. This~     study provides a timely opportunity to explore the intricate relationship between gait~     disturbances and depression severity, as well as the potential benefits of ASTM intervention~     on gait and FOF in seniors. Using a GAITRite® portable walkway, measures of stride length and~     gait velocity will be obtained for seniors in the ASTM and control study arms every four~     weeks for the duration of the ASTM program. The aim of this study is to answer the following~     research questions: are gait impairments and depression severity correlated, and does ASTM~     training have any effect on gait and FOF? The results of this study could not only provide~     insight into the physical manifestations of depression but if ASTM training is found to~     improve gait and reduce FOF then there is potential to use this mind--‐body meditation~     technique as an adjunct therapy to reduce fall risk in seniors with LLD. Furthermore, future~     research could expand upon these findings to examine the benefits of ASTM on gait impairments~     secondary to other psychiatric illnesses.~   "
98085|NCT02283372|"~     A phase I study to evaluate safety of gemcitabine with nab-paclitaxel and concurrent IMRT for~     locally advanced and borderline resectable pancreatic cancer. The goal of this study is to~     evaluate if a chemotherapy regimen that provides superior systemic efficacy may be safely~     delivered and enhance efficacy of tumor directed radiation therapy.~   "
98086|NCT02283359|"~     The main purpose of this study is to see whether the combination of selinexor (KPT-330) and~     irinotecan can help people with esophageal or stomach cancer. Researchers also want to find~     out if the combination of selinexor (KPT-330) and irinotecan is safe and tolerable.~   "
98074|NCT02283515|"~     BACKGROUND: Chronic periodontitis (CP) is an inflammatory condition affecting tooth~     supporting tissues and alveolar bone that surround the tooth leading to formation of deepend~     gingival sulcus that is highly prone to pathologic changes, ultimately bone resorption and~     tooth loss. In the literature, several pharmacologic agents have been administration via~     local delivery route, directly into diseased sites affirming greater improvement in~     periodontal status. Therefore, present study was conducted to determine the clinical~     effectiveness of subgingivally delivered 1.2% Rosuvastatin gel incorporated into an~     methylcellulose vehicle for its controlled release into intrabony defect sites in adjunct to~     scaling and root planing for treatment of chronic periodontitis patients.~      MATERIAL AND METHODS: Sixty five patients were categorized into two treatment groups: group I~     -SRP plus RSV, 1.2 mg and group II -SRP plus placebo. Clinical parameters included modified~     sulcus bleeding index (mSBI), probing depth (PD), and clinical attachment level (CAL), were~     recorded at baseline before SRP and at 1, 3, 4, and 6 months. Radiologic assessment of~     intrabony defect (IBD) fill was analysed at baseline and after 6months using computer-aided~     software.~   "
98075|NCT02283502|"~     The objectives of this program are to verify the safety and effectiveness of the MRgHIFU~     system developed by the division of Medical Engineering of National Health Research~     Institutes (NHRI)~   "
98076|NCT02283489|"~     This study will investigate the efficacy and safety of recombinant human endostatin~     adenovirus combined with chemotherapy for advanced head and neck malignant tumors.~   "
98077|NCT02283476|"~     Endostar is a anti-angiogenesis product and has been launched in China . The efficacy and~     safety have been defined. However, the compliance is unsatisfactory since routine i.v of~     Endostar is needed for 3 to 4 hours daily during one cycle of 14 days. The continuous~     intravenous infusion by using venous pump can improve the compliance.The comparative study in~     efficacy and safety has not been done concerning continuous and routine i.v.In addition, what~     patient can be benefited from Endostar have not been investigated. The biological markers,~     such as circulating endothelial cells，CECs, will be explored in the study.~   "
98078|NCT02283463|"~     This study will test a suction-based method of engaging the cervix. Bioceptive has developed~     a device that more gently and atraumatically attaches to the cervix with no bleeding. This~     novel attachment mechanism may diminish pain and discomfort. Pre-clinical testing has been~     performed on the device including testing on synthetic uterine models, human cadavers, and~     human uteri immediately post-hysterectomy (Utah IRB # 00059096). Results from these efforts~     have shown effective attachment to the cervix and the ability for the device to maintain~     suction throughout a procedure atraumatically. This study proposes to introduce this minimal~     risk device in a clinical setting to determine the response of women undergoing gynecologic~     procedures.~   "
98079|NCT02283450|"~     Purpose :Research into the impact of Qiliqiangxin capsule on IFN-γ，IL-4，NT-proBNP in dilated~     cardiomyopathy patients with heart failure.~      Methods :Data were collected from the patients with idiopathic dilated cardiomyopathy (~     cardiac function NYHA Ⅱ-Ⅳ) in the first affiliated hospital of Harbin Medical University from~     May 2012 to April 2014. These 30 cases were treated under the recommendations of normal~     diagnosis and treatment in cardiomyopathy. This experiment was randomized double-blinded，the~     experimental interferences were avoided and patients were divided into the experimental group~     and the placebo group. The patients in experimental group received the relevant tests and~     inspections before the beginning of experiment，signed the informed consent. Then the~     investigators get the venous blood centrifugalization and cryopreservation. The patients take~     the medicine qiliqiangxin three times per day，four tablets at a time. Afrer a month，the~     investigators evaluated the symptoms，the function of heart，blood pressure，heart rate and keep~     blood specimens. Three and six month later，electrocardiogram and echocardiography were taken~     and the determination of the NT - proBNP was done. The placebo group was followed up in the~     same way.~   "
98080|NCT02283437|"~     This proposed randomized controlled trial will test the effectiveness of a problem-solving~     based bibliotherapy program (PSBBP) for Chinese family caregivers in schizophrenia spectrum~     disorders. A repeated-measures, three-group design will be used to evaluate and compare the~     effects between two treatment groups(PSBBP and psycho-education group) and routine outpatient~     service and family support(control group) for 129 randomly selected family caregivers of~     outpatients with schizophrenia-spectrum disorders over a 12-month follow-up.~   "
98081|NCT02283424|"~     This is a randomized ,opened, prospective controlled trial of clinical effectiveness for~     Icotinib as the adjunctive treatment after surgery in stage I-IIIB lung adenocarcinoma~     patients with epidermal growth factor receptor gene mutation~   "
98082|NCT02283411|"~     The purpose of the study is to evaluate the safety and effectiveness of the Abbott Sensor~     Based Glucose Monitoring System Personal (System-P) and Abbott Sensor Based Glucose~     Monitoring System Professional (System-Pro) when used as an adjunct to blood glucose testing~     over a 14-day wear period in adult subjects. The Abbott Sensor Based Glucose Monitoring~     System - Professional Sensors will be worn by adult subjects over a 14-day wear period.~      The primary objective is to characterize the Systems performance with respect to Yellow~     Spring Instrument (YSI) reference venous sample measurements. The device performance will be~     primarily evaluated in terms of point and rate accuracy of the Abbott Sensor Based Glucose~     Monitoring Systems in reference to YSI.~      Safety of the Abbott Sensor Based Glucose Monitoring Systems will be characterized by Adverse~     Device Effects and Serious Adverse Device Effects experienced by study participants.~      240 subjects will be enrolled and additional healthy subjects may also be enrolled in the~     study as training subjects.~   "
98083|NCT02283398|"~     We aim to investigate whether RIPC (remote ischemic preconditioning) is effective in the TAVI~     setting to reduce post-procedural myocardial damage and improve patient outcome. Accordingly,~     we aim to investigate whether RIPC can be introduced as an integral part of the TAVI~     procedure, in order to reduce post-procedural myocardial damage and potentially improve~     patient outcome.~   "
98084|NCT02283385|"~     There is no current elder abuse service that systematically assesses and provides services to~     address the mental health needs of older adult abuse victims. The proposed study will~     investigate the efficacy of a skill-based, mental health intervention to help treat elder~     abuse victims, bolster mental health outcomes, and improve detection of symptomatology in~     future screenings.~   "
98087|NCT02283346|"~     The hypofractionated external radiation (EBRT) is a technique that radiation dose delivery~     using higher daily fractions than those used routinely. In this way can cause more damage~     tumor, especially in tissues that have a slower proliferation rate, as in the case of~     prostate cancer. Furthermore, achieves a reduction in total treatment time and probably a~     lesser chance of development of collateral in tissues of high multiplication rate as the~     lining of the rectum and bladder effects.~      With brachytherapy boost for high dose rate is achieved by administering a more intense dose~     on the tumor and lower the sound around the region to be treated tissues, improving the~     therapeutic window.~      Treatment with retracted and fully ambulatory time, has potential benefit as early patient~     return to usual activities and optimizing the flow of patients who require treatment with~     radiotherapy. This prospective study aims to assess the results and the toxicity profile of~     this treatment regimen retracted.~   "
98088|NCT02283333|"~     The purpose of this study is to compare the efficacy of an experimental treatment (termed~     BATE-G) for Prolonged Grief Disorder (PGD) in Veterans compared to the current, VA-approved~     standard of care treatment. Currently, treatments for grief in Veterans remain understudied.~     Our research group has recently completed pilot work on an innovative, technology-leveraged~     treatment protocol for PGD that combines Behavioral Activation with Therapeutic Exposure~     (BATE) and appears readily applicable to the Veteran and Military populations. Per the VA /~     DoD Iraq War Clinician Guide, 2nd ed., the current standard of treatment is Cognitive~     Restructuring and Supportive Grief Counseling.~      The study will enroll 140 Veterans, aged 21 years and older, who served in any combat era.~     All Veterans will meet criteria for PGD. There will be assessments at baseline, 1 week, 3~     months, and 6 months post treatment. During the treatment phase, Veterans will undergo 7~     weekly sessions of either BATE-G or standard treatment. Sessions 2-6 will be delivered via~     televideo to the Veteran's home.~      We hypothesize that BATE-G will be more effective than standard treatment in reducing~     symptoms of PGD, both at post-treatment and follow-up. Moreover, BATE-G will be more~     effective in reducing acute emotional distress and preventing long-term emotional distress in~     terms of general depression and anxiety symptoms. BATE-G will result in increased frequency~     of completed positively reinforcing, community-based events when compared to Cognitive~     Restructuring and Supportive Grief Counseling. BATE-G will also result in greater~     improvements in perceived social support and health.~      Note: This project is the first evidence-based treatment for PGD in military populations,~     thus addressing a significant service gap.~   "
98089|NCT02283320|"~     BIND-014 (docetaxel nanoparticles for injectable suspension) is being studied in patients~     with v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation positive or~     squamous cell non-small cell lung cancer (NSCLC) who have progressed after treatment of one~     prior platinum-containing chemotherapy regimen.~   "
98090|NCT02283307|"~     The goal of this study is to validate that Dual Energy CT (DECT) urography when performed~     with a 50% reduction in iodinated contrast dose results in a CT exam with equal or better~     image quality and equal or better diagnostic capability compared to traditional Single Energy~     CT (SECT) performed with a standard contrast dose.~   "
98091|NCT02283294|"~     The purpose of this study is to evaluate if Apixaban will decrease the complication of having~     another stroke for people who have atrial fibrillation if initiated earlier than standard of~     care.~   "
98092|NCT02283281|"~     Clinical evidence about the effects of cannabis in a perioperative setting or for the~     management of acute pain is rather scarce, mostly consisting of case report-based opinions on~     adverse events during or after general anesthesia after smoking cannabis, experimental pain~     trials in healthy volunteers, and a few clinical trials using different drugs, dosages and~     routes of administration. It is difficult to draw strong conclusions from the available~     evidence, that may seem sometimes even contradictory, mainly due -the investigators believe-~     to the many sources of variability in the study designs (e.g.: heterogeneity of the study~     samples, underpowered, unblinding, lack of randomization, timing of the therapeutic~     intervention, different experimental pain models, inclusion of different kind of surgical~     pain, etc.). Nevertheless, expert's opinion after a critical review of the literature is that~     cannabis and cannabinoids may have a beneficial role in the management of acute~     post-operative pain and nausea, at least for a selected group of patients and through an~     appropriate therapeutic intervention.~      Therefore, it seems to us pertinent to carry out an investigation in order to re-evaluate the~     issue of perioperative cannabis use through a sufficiently powered and controlled clinical~     trial. Some of cannabis effects such as sedation, bronchodilation, dryness of respiratory~     secretions, vein dilation, and increase of heart rater without producing hypertension, make~     of it an attractive option for pre-medication; while its antiemetic properties and its~     analgesic potential without causing respiratory depression may be profitable for the~     post-operative period.~      Nabiximols seem to be most suitable to our investigation. The co-administration of~     tetrahydrocannabinol (THC) with cannabidiol (CBD) may translate into additional therapeutic~     benefits with an attenuation of adverse effects. The investigators expect to obtain less~     sedation, milder high, lower incidence of anxiety, tachycardia, and hyperalgesia, as~     compared with THC-only acute pain trials.~   "
98093|NCT02283268|"~     The purpose of the study is to assess the efficacy and safety of recombinant von Willebrand~     factor (rVWF) with or without ADVATE in major and minor elective surgical procedures in adult~     patients with hereditary severe von Willebrand disease (VWD).~   "
98094|NCT02283255|"~     Introduction: Different variations of the Fontan operation has been used to treat complex~     cardiac anomalies with a single functional ventricle. This procedure has substantially~     improved quality of life and survival in patients with these complex cardiac anomalies.~     However, the cardiovascular and pulmonary functioning as well as skeletal muscle alterations~     that can explain the exercise intolerance in these patients is still poorly understood.~      Objectives: 1) To evaluate effects of different exercise programs on adolescents and adults~     with Fontan circulation.~      Methods: A long-term randomized clinical study that will include 60 patients between 12 and~     30 years, submitted to total cavopulmonary connection for at least 5 years post operative at~     the Heart Institute, University of São Paulo Medical School. The patients will be divided~     into four groups: 1) Exercise training with aerobic exercise + lower and upper limb strength~     exercise (GTF-I); 2) Respiratory training with respiratory muscle exercise (GTF-II); 3)~     Exercise training with aerobic exercise + lower and upper limb strength exercise +~     Respiratory training with respiratory muscle exercise (GTF-III); and A non-exercise group as~     control group (GNTF-IV). The patients will be revaluated after the 4-month period of~     intervention.~      Expected Outcomes: The investigators expect to demonstrate that exercise training and~     respiratory training can substantially improve the cardiovascular and pulmonary responses and~     skeletal muscle system in patients with univentricular circulation. In addition, the~     investigators wil test the hypothesis that the effects of exercise training associated with~     respiratory training on cardiovascular and pulmonary responses and skeletal muscle system may~     be greater than exercise training or respiratory training alone.~   "
98095|NCT02283242|"~     It is recognized that inflammation can be modulated by cholinergic stimulation and that~     galantamine, an inhibitor of acetylcholinesterase enzyme with central nervous system action,~     has showed an anti-inflammatory effect, reducing body weight, abdominal fat and improvement~     in tissue insulin resistance in animal models. Galantamine is a safe drug that is used to~     treat alzheimer disease.Galantamine treatments of patients with the metabolic syndrome may~     represent a significant advance in management of this disease. This study aims to investigate~     the effects of galantamine on inflammatory markers, as well as on abdominal visceral and~     epicardial fat and oxidative stress in patients with metabolic syndrome. This is a pioneering~     study that will include expert support. The enrolling of subjects will have continuous~     monitoring throughout the period of treatment. The study is a double blind randomized~     prospective study with 60 patients with metabolic syndrome, to be randomized at ratio of 1: 1~     placebo and galantamine. The dose of galanthamine is the standard clinically approved (8 and~     16 mg). The tracking method include metabolic analysis, inflammatory and oxidative stress~     markers, hemodynamic evaluation with hear rate variability (sympatho vagal modulation)~     before, during and after treatment. Computerized tomography assessment of visceral abdominal~     and epicardial fat before and after treatment will be performed.~   "
98096|NCT02283229|"~     Prospective randomized clinical interventional trial after birth in maternity ward, and~     follow up to 8-9 years of age.~      Hypothesis: Preventive handling and caring advices to parents of newborns decrease~     craniofacial asymmetries (deformational plagiocephaly and torticollis). The minimum sample~     size of the study was calculated at 86 (43 in each arm) using a 5% significance level, a~     power of 80% and a fall in the prevalence of DP from 31% to 8%. Craniofacial asymmetries and~     appearances of occlusal defects are followed up to 9 years. 50 preterm infants can~     participate without intervention.~   "
98097|NCT02283216|"~     The purpose of the study is to investigate different stimulation parameters for a new~     noninvasive approach for modulating the brain that could potentially be beneficial for~     decreasing tinnitus perception. The new approach is called Multimodal Synchronization Therapy~     (mSync). mSync uses a combination of acoustic stimulation played through headphones and low~     levels of electrical current delivered via electrodes placed on the surface of different body~     regions. The timing interval between the acoustic and body stimulation is varied in order to~     cause different types of changes in the brain. In addition to acoustic and body stimulation,~     noninvasive cortical stimulation will also be presented as part of mSync to attempt to~     further modulate or decrease the tinnitus percept. Cortical stimulation will be performed by~     placing a magnetic coil over a spot on the head and sending a brief magnetic pulse that can~     travel through the skin and bone to create electrical current inside the head. For this~     study, different body locations as well as specific timing intervals among acoustic, body,~     and cortical stimulation will be investigated to identify appropriate parameters that can~     modulate and potentially decrease tinnitus perception. Different mSync parameters will be~     investigated across multiple testing sessions (up to 16 weekly sessions) and the tinnitus~     percept will be closely monitored throughout the study.~   "
98098|NCT02283203|"~     The efficacy of intravenous paracetamol has never been compared with other drugs for the~     management of fever due to infections. Available data come from clinical studies conducted in~     healthy volunteers subject to experimental endotoxemia. The present study compares the~     efficacy of the new ΑPOTEL Μax® formulation versus placebo for the management of fever of~     infectious origin.~   "
98099|NCT02283190|"~     Erwinaze will be administered intravenously at a dose of 25,000 IU/m2 (dose cohort 0) for 6~     doses MWF over a period of 2 weeks to 9 patients (as described below and in the following~     schema). Blood counts, chemistries including bilirubin, amylase and lipase, and coagulation~     studies including fibrinogen will be measured and reviewed before each asparaginase dose.~     Fibrinogen (<100 mg/dL) can be replaced with cryoprecipitate before each dose at the~     discretion of treating physician. Treatment will be stopped for elevation of amylase, lipase~     or direct bilirubin above normal range.~   "
98100|NCT02283177|"~     This pilot study is designed to evaluate the safety and tolerability of oral crenolanib~     besylate given sequentially during standard induction and consolidation chemotherapy in~     patients with newly diagnosed AML with FLT3 activating mutations.~   "
98101|NCT02283164|"~     The goal of this research is to evaluate the efficacy of an audit and feedback intervention~     to improve personal protective equipment (PPE) use by nurses who handle hazardous drugs in~     the ambulatory oncology setting.~   "
98102|NCT02283151|"~     The study was designed to investigate the effects of a very low carbohydrate diet (VLCD)~     intervention on weight control in overweight/obese patients in China.All the subjects were~     randomly assigned to experiment group and control group. The experimental group was given~     individual instructions on how to follow the VLCD (very low carbohydrate diet). The control~     group was given an energy-restricted diet.The energy-restricted diet (ER diet) was designed~     in the traditional Chinese style with an initial target for a total energy intake of 1200~     kcal/d (5021 kJ/d).~   "
98103|NCT02283138|"~     The investigators will measure fetal lung volume by VOCAL and pulmonary artery resistance~     index in preterm fetuses and correlating the results with postnatal respiratory distress of~     the preterm neonates.~   "
98104|NCT02283112|"~     This study aims to ensure that assays that measure drug concentrations are accurate and~     precise in different matrices when quantified using high performance liquid chromatography~     -tandem mass spectrometry (HPLC-MS/MS). The study involves collecting samples of various~     bodily fluids to quantify antimicrobials, antivirals, oral contraceptives and erectile~     dysfunction agents. Samples will also be obtained from individuals not receiving these~     medications for quality control purposes.~   "
98105|NCT02283099|"~     The study is designed to establish safety, tolerability and immunogenicity of rVSVΔG-ZEBOV-GP~     (BPSC1001), an Ebola Virus Vaccine candidate (recombinant vesicular stomatitis virus (VSV)~     expressing the envelope glycoprotein of Ebola Virus Zaire), investigated at three different~     dose levels in 30 healthy adults in Germany. This study is part of the WHO led VEBCON~     consortium that is aiming to generate harmonized data for the rVSVΔG-ZEBOV-GP (BPSC1001)~     vaccine candidate to allow optimized rapid decisions on dose and safety.~   "
98847|NCT02273414|"~     The objective of the present study is to obtain information about the safety and tolerability~     of BIIL 284 BS after repeated dosing, to find the pharmacologically active dose range by~     determination of the surrogate marker CD 11b (= Mac-1) and to obtain preliminary~     pharmacokinetic data concerning steady state and accumulation factor~   "
98106|NCT02283086|"~     DESIGN: An IRB-approved, HIPAA-compliant prospective randomized controlled trial conducted~     from January 1, 2012-December 31, 2013.~      SETTING: The ED of an urban Level-I adult trauma center with existing CDS for CTPE.~      PARTICIPANTS: All attending physicians were stratified into quartiles by 2012 CTPE use and~     randomized to receive feedback reporting or not.~      INTERVENTION: Quarterly performance feedback reports consisting of individual and anonymized~     group data on EBG adherence (using the Wells criteria), CTPE use (CTPEs per 1,000 patients),~     and yield (percentage of CTPEs positive for PE) beginning January 2013.~   "
98107|NCT02283073|"~     The main objective of the study is to design and validate the blood based PDx gene expression~     assay for the early diagnosis of Parkinson's disease patients. Differential diagnosis~     includes patients with Multiple System Atrophy, Progressive Supranuclear Palsy, Corticobasal~     Degeneration, Lewy Body Dementia, Essential Tremor and Normal Controls.~   "
98108|NCT02283060|"~     Atripla and Stribild are two FDA-Approved one pill a day combination antiretroviral~     medications given for the treatment of HIV. Both drugs are reasonably well tolerated.~     However, efavirenz, a component of Atripla, is known to cause mental side effects.~      This proposal aims to assess whether a switch from Atripla to Stribild for 12 weeks will be~     associated with reversal of sleep and cognitive disturbances. Demonstrating changes upon~     withdrawal of drug and substitution of a drug regimen not known to have an impact on sleep~     and cognition may represent the best option to determine whether use of efavirenz is~     associated with effects on sleep and cognition beyond the immediate period following~     initiation of drug.~   "
98109|NCT02283047|"~     Obesity and arterial hypertension (HTN) frequently coexist in the same patient. Moreover, the~     concept that obesity and HTN can be additive in terms of cardiovascular rist is widely~     accepted. Yet, clinical decision-making in obese patients is complicated by a surprising lack~     of evidence on the relative importance of obesity and HTN treatment and its efficacy and~     safety. Lifestyle interventions are the mainstay of obesity management programs and are also~     advocated in the prevention and treatment of HTN. Physical exercise and diet are recommended~     to prevent and control obesity and HTN. Aerobic exercise is firmly established as an~     effective measure for lowering blood pressure and reducing cardiovascular risk. However,~     there is no agreement about the optimal dose of frequency, intensity, duration and type of~     exercise. Therefore, the aims of the study are: 1) to assess the changes in selected~     parameters of blood pressure, cardiorespiratory fitness, body composition and biological~     markers brought about by a period of 16-week of different aerobic exercise programs with~     hypocaloric diet for overweight or obesity and primary hypertensive adults, and 2) to examine~     the effect of six months detraining subsequent to intervention. Secondary objectives are to~     examine the additional effect of the intervention on physical activity behavior and~     health-related quality of life.~   "
98110|NCT02283034|"~     The aim of this study was to compare five CPR feedback devices to standard BLS in terms of~     the quality of single rescuer pediatric resuscitation. Therefore, the investigators~     hypothesis was that there would be no difference between CPR methods in terms of chest~     compression quality parameters.~   "
98111|NCT02283021|"~     Calcium is an extremely important ion used in our body for many processes. One of its tasks~     is to control gene expression. Cells intake calcium from their surroundings though special~     calcium channels located on the surface membranes of the cells.~      The great many studies on such calcium channels were performed on excitable cells such as~     muscle, heart or neuronal cells, where the calcium ions are controlled by voltage.~     Surprisingly, not much is known about the identity of calcium subunits in non-excitable cells~     like epithelial cells (which compose most of the connective tissue in the body), liver cells,~     lung cells, immune system cells, etc.~      Recently, the investigators have shown that calcium channels from muscles are, in fact,~     expressed in T cells of the immune system, where they are used for proliferation. The~     investigators postulated that probably other cell types, especially cancerous cell types,~     might be using these subunits similarly.~      The aim of this study is to determine the identity and sequence of calcium subunits expressed~     in non-small cell Lung Carcinoma (NSCLC), which accounts for 80% of the worldwide lung cancer~     deaths.~   "
98112|NCT02283008|"~     The evidence for poor inhaler technique is both well established and observed worldwide. What~     is unclear from the evidence is why individuals demonstrate poor technique, despite the~     majority admitting to having previously had instruction on inhaler technique. The primary~     research question is 'Will there be a difference between post education inhaler technique~     scores when comparing structured education against informal education?'~      To try and establish why individuals use inhalers incorrectly a semi structured interview is~     proposed~   "
98113|NCT02282995|"~     Background:~      Functional dyspepsia (FD) is one of the commonest digestive disorders. The pathophysiology of~     functional dyspepsia is uncertain. Risk factors include genetics, gender, age, helicobacter~     pylori infection, etc. However, few reported the association of genetic contribution to the~     development of FD and mood disorder.~      Indication:~      Functional dyspepsia patients~      Study center(s):~      Prince of Wales Hospital, Hong Kong~      Aims:~        -  To evaluate genetic factors on development of functional dyspepsia & common mood~          disorders~        -  To evaluate genetic factors on the severity of function dyspepsia & mood disorders~        -  To develop a diagnostic test for classification of functional dyspepsia by plasma~          ghrelin and serotonin expression~        -  To collect sleep data for future use~        -  To save blood sample for future retrospective diagnostic or genetic examination~      Study design:~      Case-control cross sectional study~      Number of subjects:~      Total of 1200 subjects (300 FD patients + 300 relatives of FD patients FDR) and (300 Controls~     + 300 FDR)~      Patient population:~      Functional dyspepsia patients age 18-60~      Duration of study:~      1 May 2012 - 30 April 2013~      Primary variable(s):~      Genetic polymorphisms of targeted genes, plasma ghrelin and serotonin expression~      Secondary variable(s):~      FD global symptom assessment and symptom scores~      Number of visits: 1~      Hypotheses:~        -  Shared genetic factors contribute to the development of FD and common psychological~          disorders~        -  FD patients contribute to suppression of plasma ghrelin and serotonin expression~          compared to healthy controls~   "
98271|NCT02280928|"~     The purpose of this study is to (1) develop and test the effectiveness of home-based~     interventions on dual-task performance in older adults; and (2) determine the~     generalizability of the four trainings (i.e. single-task motor training, single-task~     cognitive training, dual-task motor-cognitive training, and dual-task cognitive-cognitive~     trainings) to novel tasks.~   "
98114|NCT02282982|"~     This was a non-interventional, prospective, multi-center study with no control group designed~     to assess the effectiveness of palivizumab in a population of infants at high-risk of serious~     Respiratory Syncytial Virus (RSV) illness (infants born ≤ 35 weeks of gestation and infants~     ≤24 months with Bronchopulmonary Dysplasia (BPD) or Congenital Heart Disease (CHD)).~     Participants received immunoprophylaxis during the RSV season, defined as October 2014~     through April 2015, in routine clinical settings throughout the Russian Federation.~   "
98115|NCT02282969|"~     Objectives:~      This protocol addresses the first phase of a larger project funded by the Patient-Centered~     Outcomes Research Institute to help heavy smokers make informed decisions about lung cancer~     screening with low-dose computed tomography (CT). A separate IRB protocol will be submitted~     for the larger, comparative study. In this initial development phase, our prototype patient~     decision aid will be updated to reflect current guidelines about lung cancer screening. The~     updated aid will then be pilot-tested in a new sample of patients. In addition, several of~     the study measures will be refined and further developed in preparation for the larger study.~      The specific aims of the measures and decision aid development phase of this project are as~     follows:~      Update the aid to reflect current screening guidelines and refine the aid via cognitive~     testing with patients/smokers; and pilot test the updated aid for acceptability with~     patients/smokers.~      Modify our current measure of lung cancer knowledge, conduct cognitive testing of the new~     measure with patients/smokers, and evaluate the reliability of the new measure in a sample~     patients/smokers.~   "
98116|NCT02282956|"~     Hallux surgery is known to be extremely painful. Standard pain therapy is treatment with~     NSAID and opioid painkillers. Patients are frequently not-satisfied with this. Some~     institutions use a nerve block (single shot or catheter technic) of the ischiadic nerve. But~     this procedure is invasive, has a potential risk of nerve lesion, and is not accepted by all~     surgeons. A single shot nerve block of the posterior tibial nerve is less invasive and could~     be superior compared to standard pain treatment. A great variability of nerve supply of the~     foot is well described. There are some hints that the posterior tibial nerve supplies the~     first metatarsal bone and the first metatarsal joint. A nerve block could reduce~     postoperative pain in hallux surgery. To assess the effectiveness of this investigated~     measure, the requested morphine dose of a PCA pump will be used to verify the effectiveness~     of the tibial nerve block.~   "
98117|NCT02282943|"~     The purpose of this study is to compare laser CO2 ablation/excision of Endometriosis (AFS~     stages 1-3) with excision of endometriosis using the Ethicon Harmonic ACE device. Pain scores~     at 6 months was the primary outcome, but secondary outcomes assessed pain scores at 1, 3 and~     5 years as well as psychological state and quality of life.~   "
98118|NCT02282930|"~     This study is designed to answer whether patients with progressive IgA nephropathy, who~     receive Acthar (ACTH) gel injection at a dose of 80 units subcutaneously twice weekly for 6~     months is effective in inducing improvement in proteinuria and renal function.~   "
98119|NCT02282917|"~     This will be a multi-center, proof of concept phase 0 study to assess the suppression of~     p-AKT in Vestibular Schwannoma (VS) and meningiomas by AR-42 in adult patients undergoing~     tumor resection. AR-42 is a small molecule which crosses the blood brain barrier (BBB) in~     rodents, but the investigators are not certain yet if it will penetrate human VS. Meningiomas~     are outside the BBB, but seem to be unusually resistant to all current medical treatments.~     The primary endpoint of the bioactivity of suppression of p-AKT by AR-42 was selected as drug~     activity seems more informative than bioavailability. Our preclinical data and others have~     shown dose dependent suppression of p-AKT by AR-42 in both VS and meningiomas.~   "
98120|NCT02282904|"~     Background:~      - Chronic Granulomatous Disease (CGD) causes immune system problems. Treatment is usually a~     bone marrow transplant from a fully matched donor. Researchers want to try using partially~     matched donors for patients who do not have a fully matched donor available. The researchers~     will also use the drug cyclophosphamide to try to improve the outcomes when using a partially~     matched donor.~      Objective:~      - To learn the effectiveness of using cyclophosphamide with a transplant from a partially~     matched donor in treating CGD.~      Eligibility:~      - Recipients: age 2-65 with CGD with an ongoing infection that has not been cured by standard~     treatment and no fully matched donor available in an appropriate timeframe.~      Design:~        -  Recipients will:~             -  be admitted to the hospital 2 weeks before transplant.~             -  be screened with blood and urine tests, breathing and heart health tests, X-rays,~               and/or magnetic resonance imaging. They may have a bone marrow aspiration and~               biopsy.~        -  meet with a social worker and dentist.~        -  get chemotherapy, radiation, and other medicines.~        -  get an intravenous (IV) catheter in their chest.~        -  have the transplant.~        -  get more medicines and standard supportive care.~        -  have blood drawn frequently.~        -  have to stay in the Washington, D.C. area for 3 months post-transplant.~        -  be followed closely for the first 6 months, and then less frequently for at least 5~          years.~   "
98121|NCT02282891|"~     The purpose of this study is to compare the hemodynamic effects of a standardized induction~     of general anesthesia with either propofol or ketofol in patients with physical status~     classification ASA 3. The study will be a double blinded, randomized controlled trial (RCT)~     with two arms of treatment groups. One arm will consist of induction of general anesthesia~     using a mixture of 1.5mg/kg:0.75mg/kg Propofol/ketamine (ketofol) and the induction dose will~     be 1.5mg/kg of propofol and 0.75mg/kg of ketamine; the second arm will consist of induction~     of general anesthesia using propofol 2mg/kg. The primary outcome of the intervention will~     consist of hemodynamic changes during the first 30 minutes after induction of general~     anesthesia.~   "
98122|NCT02282878|"~     The purpose of this work is to investigate the influence of dietary salt intake on immune~     function in multiple sclerosis (MS) subjects and healthy controls. This study primarily tests~     the hypothesis that higher dietary salt intake will be associated with a higher frequency of~     pathogenic Th17 cells and impaired function of protective regulatory T cells. If a~     relationship between dietary salt intake and immune function is observed, this study will~     also test: a) whether this relationship is unique to MS subjects or whether it is also~     present in healthy controls, and b) whether healthier immune function can be restored by~     restricting dietary salt intake.~   "
98272|NCT02280915|"~     The study is designed to assess the bioavailability of iron from 4 different iron fortified~     savoury food products~   "
98848|NCT02273401|"~     To investigate safety, tolerability, and pharmacokinetics of BI 11054~   "
98123|NCT02282865|"~     Heart rate variability (HRV) is known to reflect the balance of autonomic nervous system.~     Anxiousness, which tend to result from the deficient action of parasympathetic nervous~     system, likely to show low HRV. This study is to investigate the relationship between the~     surgery-related anxiety and the HRV which is known to reflect the balance of autonomic~     nervous system. Furthermore, this study also focuses on HRV's role as a predictor for~     aggressive emergence behavior, which might also be considered as partially related to~     imbalance of autonomic nervous system.~   "
98124|NCT02282852|"~     Small bowel wireless capsule endoscopy is the investigation modality of choice for suspected~     diseases of the small bowel. The procedure is safe and noninvasive, the main risk being~     capsule retention occurring in approximately 2% of procedures. Other problems such as~     incomplete examinations occur in 10-20% of procedures. Reasons include delayed gastric~     emptying, slow small bowel transit, faulty equipment and poor bowel preparation.~      Some protocols identify the capsule position 30 minutes after ingestion using a 'realtime'~     viewer. If the capsule remains in the stomach, mobilisation is encouraged followed by an~     intramuscular prokinetic injection if this fails. This approach has disadvantages since an~     intramuscular injection is uncomfortable for patients. Additionally metoclopramide, commonly~     used for this purpose, has a risk of acute dystonic reactions particularly in young patients.~      Recently a handheld magnet (Intromedic Ltd.) has been developed to enable control of the~     capsule in the upper GI tract. We propose that this could be used, alongside positional~     changes, to expedite capsule transit through the stomach thus improving completion rates and~     avoiding the risks of unnecessary medication. We wish to undertake a randomised controlled~     study comparing a standard protocol for small bowel capsule endoscopy against a hand held~     magnet and positional change protocol to enhance gastric emptying of the wireless capsule.~   "
98125|NCT02282839|"~     This study will enroll 60 consecutive patients who are scheduled to receive radiotherapy~     with/without chemotherapy due to head and neck cancers. Basic data will be recorded along~     with tumor related variables. Then they will be divided randomly into study group and control~     group. The study group will receive oral glutamine during radiotherapy while the control~     group will receive placebo during radiotherapy. The severity of oral mucositis (WHO grading~     system), pain status (visual analogue scale), quality of life questionnaires will also be~     documented. The differences between the two groups will be analyzed.~   "
98126|NCT02282826|"~     Primary Objective:~      To assess the safety and tolerability of GZ402668 after ascending single intravenous (IV) and~     subcutaneous (SC) doses in men and women with progressive multiple sclerosis.~      Secondary Objectives:~      To assess the following in men and women with progressive multiple sclerosis:~        -  The pharmacokinetic (PK) parameters of GZ402668 after ascending single IV doses.~        -  The pharmacodynamics (PD) of GZ402668 after ascending single IV doses.~        -  The PK parameters of GZ402668 after ascending single SC doses.~        -  The PD of GZ402668 after ascending single SC doses.~   "
98127|NCT02282813|"~     This extension study of subjects previously enrolled in studies CTAP101-CL-3001 or~     CTAP101-CL-3002 allows long term evaluation of the safety and efficacy of CTAP101 Capsules in~     reducing elevated intact parathyroid hormone (iPTH) and correcting vitamin D insufficiency in~     stage 3 or 4 chronic kidney disease patients.~   "
98128|NCT02282800|"~     The study was to intended to visualize the nuclear localization of vitamin D receptor in oral~     tissues of aggressive periodontitis patients to better understand the potential for receptor~     in disease activity or progression.~   "
98129|NCT02282787|"~     During LA in retinal surgery there is some problem as regard the lack of anaesthesia duration~     and unexpected globe movement .so many adjuvant was added to LA to overcome this~     disadvantages of LA such as clonidine and fentanyl .~      The investigators hypothesis is adding dexmedetomidine to pribulbal blocking LA will prolong~     anaesthesia duration and improve globe akinesia and decrease intraoperative supplementation~     of LA.There are Many studies had described the effects of dexmedetomidine on peripheral nerve~     blocks, spinal but up to date no knowledge is available on the impact of dexmedetomidine~     adjuvant to local anaesthetic in ophthalmic surgery~   "
98130|NCT02282774|"~     To evaluate the effects of subtenon block (SB) as an adjunct to general anaesthesia on~     postoperative pain, oculocardiac reflex and postoperative nausea and vomiting for~     vitreoretinal surgery.~   "
98131|NCT02282761|"~     The study will be conducted as a randomized, double-blind, parallel-group,~     placebo-controlled, multi-center study in patients diagnosed with schizophrenia having an~     acute exacerbation of psychosis.~   "
98132|NCT02282748|"~     The planned research project is a prospective population-based cohort study, similar to the~     well-known Framingham study in the United States. So far, there is no similar research~     project in Switzerland.~      It is planned to start with an initial cross-sectional examination of four Swiss~     municipalities (Buttisholz LU, Glarus Süd GL, Lostallo GR and Cama GR) in 2014.~     Cross-sectional follow-up examinations will be performed after 5 and 10 years and in 10-year~     intervals thereafter.~      The examinations embrace a broad spectrum of measurements (for details the investigators~     refer to the study protocol).~   "
98137|NCT02282683|"~     Patients with advanced (ACCF/AHA stage D) heart failure and hyperuricemia have high one-year~     mortality. Currently, there was no evidence-based therapy such as mechanically assisted~     circulatory support available in China. The investigators found glucocorticoid treatment such~     as prednisone could improve cardiac performance, potentiate renal responsiveness to diuretics~     in such patients. Therefore, it could be used as bridge therapy to help ACE inhibitors or~     beta blocker titration. With its help, most of the patients with stage D heart failure could~     be titrated to higher dose of ACE inhibitors and beta blockers during hospitalization.~     However, the efficacy of long-term, low-dose of prednisone use in such patients with limited~     life expectancy remain unclear. Therefore, the investigators designed this study to observe~     whether putting low-dose of prednisone on the patients with stage D heart failure for long~     term could further improve their survival. All patients will receive prednisone treatment~     during hospitalization and receive maximum tolerated guideline-directed medical therapy~     (GDMT). After discharge from hospital, the patients will be randomized to receive long-term,~     low-dose prednisone treatment or standard GDMT.~   "
98138|NCT02282670|"~     This is a multicenter, active-controlled, randomized, double-blinded, paralleled group~     clinical study to evaluate the efficacy and safety of DA-5204 and to demonstrate the~     non-inferiority of DA-5204 compared with Stillen® tab. in patients with acute or chronic~     gastritis.~   "
98133|NCT02282735|"~     Parental decision-making for children with advanced cancer is complex. Many parents have~     overly optimistic beliefs about prognosis and as a result choose aggressive measures even at~     the end of life, which are associated with greater suffering. Yet most parents wish to limit~     suffering, and in retrospect, many regret choices for cancer treatment for advanced cancer.~     These findings suggest that parents do not always have the information they need to make~     decisions that reflect their preferences.~      The proposed study will evaluate parental decision-making in advanced cancer, addressing gaps~     in the literature in 3 important respects. 1) Previous work on decision-making for children~     with advanced cancer has typically looked at decisions at one point in time, often asking~     parents to reflect on decisions after the child's death, even though parents' understanding~     of prognosis and decisions about care evolve over time. We will evaluate parental~     decision-making for advanced cancer over time. 2) Existing work focuses on aggressive~     end-of-life care as the worst possible outcome. However, some parents wish to pursue~     aggressive measures even when they recognize that the child has little chance for cure. We~     will evaluate the extent to which parental decision-making is informed and consonant with~     preferences, regardless of whether decisions lead to aggressive or palliative care. 3)~     Previous studies have focused on groups of different childhood cancers, making it difficult~     to ascertain whether differences in decision-making reflect differences in diseases, options~     for care, or parent preferences. We will focus on a single disease, relapsed neuroblastoma,~     as a model for parental decision-making.~   "
98134|NCT02282722|"~     Patients are routinely asked to sign an informed consent document prior to starting~     chemotherapy, indicating they understand the risks and benefits of treatment. Although this~     could be a strategic moment to equip patients with information they need to make truly~     informed medical decisions, many patients and caregivers note that these conversations are~     less useful than they could be. The informed consent process and its associated documents~     suffer several limitations: 1) risks are emphasized over benefits; 2) educational materials~     focus on individual drugs instead of regimens; 3) information is presented in written instead~     of alternative written/audiovisual format; and 4) the patient perspective is lacking.~      The overarching objective of this project is to develop a library of communication tools for~     the most common chemotherapy regimens used to treat advanced gastrointestinal cancers. Tools~     will include video clips and written documents that can be readily distributed, modified, and~     customized. This toolkit will be crafted in collaboration with oncologists and patients~     living with gastrointestinal cancer and improves upon existing resources in several ways: 1)~     balanced discussion of benefits as well as risks, 2) focus on regimens rather than drugs, 3)~     use of both written and video format, and 4) inclusion of the patient perspective (e.g. video~     clips of patients describing their experience). A panel of oncologist and patient~     stakeholders will evaluate the acceptability of the tools. The investigators will then~     conduct a randomized clinical trial to demonstrate if the informed consent toolkit improves~     the quality of informed consent for palliative chemotherapy. If effective, the tools will be~     amenable to broad dissemination via patient accessible cancer education websites and oncology~     clinics.~   "
98135|NCT02282709|"~     Rationale: Chronic HCV infection is characterised by a weak HCV specific CD8+ T cell~     response, due to continuous pressure of high viral load. Treatment of chronic HCV patients~     with ASV and DCV will result in a significant drop in HCV viral load. At present, no~     information is available on the immunological effects of treatment with ASV and DCV, nor on~     the early effects of viral load reduction caused by a compound that is thought not to possess~     direct immunomodulatory effects. This information will be crucial for a better understanding~     of the mechanisms that may limit the effectiveness of treatment, occurrence of viral rebound~     or relapses during, at the end of treatment or during the follow up period.~      Objective: To evaluate in detail the functionality of immune cells in blood in chronic HCV~     patients before, during and after treatment with ASV and DCV, in an IFN-free regimen.~      Study design: This is an investigator-initiated single center open label study with one arm~     of 12 patients.~      Study population: Adult chronic HCV patients with genotype 1b, who are previous~     non-responders to the treatment.~      Intervention (if applicable): All patients will be treated with twice daily a 200 mg oASV and~     once daily a 60 mg DCV for 24 weeks.~      Main study parameters/endpoints:~        1. Phenotype and function of blood leukocytes during treatment; frequency of HCV-specific T~          cells, NK cells and monocytes~        2. Gene expression levels of leukocyte populations before, during and after treatment~        3. Gene expression levels of the type I IFN signaling pathway on whole blood samples~        4. Serum cytokines levels using multiplex platforms~   "
98136|NCT02282696|"~     This study aims to validate the CARES, a needs assessment instrument which can be used to~     inventorize cancer patients biopsychosocial distress and care needs.~        -  QUANTITATIVE PART OF THE STUDY: Patients need to fill in a questionnaire package~          containing questions about social-demographic and medical data, the CARES and convergent~          measures: Karnofsky Performance Scale (KPS), Hospital Anxiety Depression Scale (HADS),~          Social Support List (SSL), Maudsley Marital Questionnaire (MMQ), European Organisation~          for Research and Treatment of Cancer Quality Of Life Core 30 (EORTC-QOL-C30), Distress~          Thermometer (DT) and a Care Needs Questionnaire. One week after the first questionnaire~          package participants have to fill in the CARES a second time and answer some questions~          to evaluate the feasibility of the CARES.~        -  QUALITATIVE PART OF THE STUDY: Participants from the quantitative part of the study and~          other (ex-) cancer patients who not have to fulfill the criteria of age and cancer stage~          can participate in a focus group interview. In these focus groups the content validity~          and preferences on psychosocial screening in care are discussed.~   "
98139|NCT02282657|"~     Pathophysiological, experimental and clinical data suggest that an 'ultraprotective~     mechanical ventilation strategy may further reduce VILI and ARDS-associated morbidity and~     mortality. Severe hypercapnia induced by VT reduction in this setting might be efficiently~     controlled by ECCO2R devices. A proof-of-concept study conducted on a limited number of ARDS~     cases indicated that ECCO2R allowing VT reduction to 3.5-5 ml/kg to achieve Pplat<25 cm H2O~     may further reduce VILI.~   "
98415|NCT02279043|"~     This study will look at women's social communication about IUDs (intrauterine devices) and~     their attitudes and behavior related to IUD use. The researchers will design an online~     community where women can talk to each other about their experiences with birth control. We~     will examine whether social exposure to IUD users in this setting is associated with change~     in attitudes and behavior among women who have never had an IUD.~   "
98140|NCT02282644|"~     The recent data suggest that cancer cells at the origin of prostate cancer metastases can be~     detected in an early stage. Available techniques allow phenotypic analysis of cancer cells in~     circulating blood (cellsearch) or in marrow hematopoietic (flow cytometry). Pilot study on~     180 patients infected by prostate cancer at all stage of disease, show that c-met marker ,~     integrin alpha 2 and 6 expressed in marrow and quantified by flow cytometry were predictor of~     metastatic progress. In this new study the investigators will analyze antibody panel by~     cellsearch and flow cytometry on marrow sample of castration-Resistant prostate cancer~     patients.~   "
98141|NCT02282631|"~     The aim of this study is to investigate whether an incentive scheme is a feasible approach to~     increase walking/cycling to school.~   "
98142|NCT02282618|"~     Although current pharmaceutical therapies have improved the survival rate in heart failure it~     remains a fatal disease and is associated with a poor 3-year survival. Increased sympathetic~     activity found in patients with heart failure plays an important role in the pathogenesis and~     development of the disease[Provide reference]. Excessive activation of sympathetic tone~     contributes to arrhythmogenesis, increased cardiac wall tension, and platelet aggregation,~     promoting a vicious cycle[What cycle? Elaborate. ] in these patients.~      High thoracic epidural anesthesia (HTEA) can reversibly and regionally block the cardiac~     sympathetic nervous system. The method was pioneered by Prof. Liu Fengqi in 1995, and he has~     accumulated clinical experiences from thousands of cases. His anecdotal experience indicates~     that the method can favorably improve intractable angina, dilated cardiomyopathy, and~     advanced heart failure. Though the method has been used to treat patients at our center for~     many years, there has been no prospective trial of its effects on cardiovascular function, or~     its efficacy to improve clinical outcomes.~      The investigators propose to investigate the immediate physiologic effect and clinical~     effectiveness of HTEA in treating heart failure.~   "
98143|NCT02282605|"~     Study to determine the efficacy, safety and tolerability of two concentrations of XF-73 nasal~     gel in combination with body and face washing with chlorhexidine gluconate cloths in~     eradicating nasal carriage of Staphylococcus aureus.~   "
98144|NCT02282592|"~     The role among metabolic syndrome and breast cancer risk is not well understood and must be~     further explored. The objective of this study is to evaluate the association between~     metabolic syndrome and breast cancer in Southern Brazil. In this case-control study, breast~     cancer patients and controls without malignant disease, matched for age (±5 years) and~     menopausal status, were interviewed and asked to make a glucose, HDL-cholesterol and~     triglycerides test. Waist circumference and blood pressure were measured using standardized~     procedures. Metabolic Syndrome was considered by NCEP ATP III (2001) and IDF (2006)~     definitions. Cases and controls were compared in relation to the presence of diagnosed MetS~     (yes/no), number of metabolic abnormalities identified (1 to 5) for each definition, and~     according to each metabolic abnormality cutoff point.~   "
98145|NCT02282579|"~     The purpose of this retrospective observational study was to analyze the effect of targeted~     therapies administered as second-line treatment after failure of pazopanib as well as~     increase the amount of information available on efficacy and safety of pazopanib as a~     first-line therapy in practice usual for the clinical treatment of metastatic Renal~     Carcinoma.~   "
98146|NCT02282566|"~     This study investigates whether a protein-nutrition beverage can increase muscle protein~     synthesis to a similar magnitude as a control beverage.~   "
98147|NCT02282553|"~     This is a pilot prospective single blind controlled trial comparing magnetically steerable~     gastric capsule endoscopy to conventional oesophagogastroduodenoscopy in diagnosing upper~     gastrointestinal pathology in patients with recurrent/refractory iron-deficient anaemia.~   "
98148|NCT02282540|"~     The purpose of the study is to establish wether a contrast medium applied to the middle ear~     can be used to diagnose pathology in the auditory tube. We will examine patients with and~     without middle ear disease with CT after the application of an iodine based contrast medium.~   "
98149|NCT02282527|"~     Grifols Therapeutics Inc. conducted a multi-center, randomized, double-blind, crossover study~     to evaluate the safety, immunogenicity, and pharmacokinetics (PK) of Liquid Alpha₁-PI~     compared to the currently licensed product, Prolastin-C, in subjects with Alpha₁-Antitrypsin~     Deficiency (AATD).~   "
98150|NCT02282514|"~     Non-myeloablative regimens (as the investigators use herein) are designed to maximally~     suppress the immune system without destruction of the bone marrow stem cell compartment.~      When using a non-myeloablative regimen recovery occurs without infusion of stem cells and the~     stem cells are autologous. While not necessary for recovery, stem cell infusion may shorten~     the interval of neutropenia and attendant complications. Thus in reality there is no~     transplant only an autologous supportive blood product.~      Based on our encouraging results of non-myeloablative hematopoietic stem cell~     transplantation, for patients with multiple sclerosis and chronic inflammatory demyelinating~     polyneuropathy, the investigators will investigate the role of non-myeloablative~     hematopoietic stem cell transplantation for patients with SPS who require assistance to~     ambulate.~   "
98151|NCT02282501|"~     Enteral alimentation is the preferred modality of support in critical patients who have~     acceptable digestive function and are unable to eat orally, but the advantages of continuous~     versus intermittent administration are surrounded by controversy.~      This prospective, randomised study was designed to compare two enteral feeding methods with~     respect to changes in levels of leptin and ghrelin in ICU.~   "
98152|NCT02282488|"~     A double blind, controlled, randomized, single site clinical trial of 2 parallel groups (Low~     protein formula =LoF and High protein formula =HiF) with a breastfeeding group (BF) as~     reference from birth to 1 year of age and a follow up period from 1 year to 5 years of age.~   "
98153|NCT02282475|"~     Obesity, increased abdominal fat, fat stored in the liver, and insulin resistance may all be~     associated with adverse maternal and fetal pregnancy outcomes. This study will examine how~     fat storage changes during pregnancy; and if how the body stores fat impacts one's ability to~     metabolize glucose (sugar) during pregnancy.~   "
98154|NCT02282462|"~     A 2 x 2 randomized study testing active versus passive drainage and regulated versus~     unregulated pleural pressure in patients undergoing anatomic lung resection~   "
98416|NCT02279030|"~     The purpose of this study is to assess if Single Photon Emission Computed Tomography (SPECT)~     demonstrating cardiac innervation can be integrated into current electrophysiology voltage~     mapping system and provide improved guidance for ablation of PVCs.~   "
98155|NCT02282449|"~     Patients with cancer often require intravenous chemotherapy for long periods of time.~      Ensuring that these patients have safe and reliable access to the veins for chemotherapy is~     challenging, and sometimes a medical device is required to administer the chemotherapy into~     the veins.~      A totally implanted venous access device, or port, is implanted under the skin of the arm and~     is attached to a small plastic catheter that enters into the veins. This device can be~     punctured with a needle when needed for treatment or testing.~      Some types of these vein ports can rapidly inject fluids (power injection), and can be used~     for follow-up imaging studies, such as computed tomography, that are required to follow~     cancer treatment effectiveness. There are no publications of randomized patients discussing~     the impact of power injection upon TIVAD complications and device longevity for arm~     implantation. The investigators propose to compare the effectiveness of power injectable~     against non-power injectable ports to determine if they have different clinical performance~     and complications. Our results will impact the care provided to cancer patients.~   "
98156|NCT02282436|"~     Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality~     worldwide. Its prevalence is in progression and COPD is expected to become the fourth leading~     cause of death by 2030. COPD is characterized by periods of stability interspersed with acute~     infectious/inflammatory flare-ups, also called acute exacerbations, during which patients~     deteriorate, sometimes to the point of requiring immediate medical assistance. Although most~     patients eventually recover, repeated episodes of exacerbations may accelerate COPD~     progression. Exacerbations may further compromise the integrity of limb muscles by promoting~     further loss in muscle mass and strength.~      The overall objective of this substudy is to elucidate how an acute COPD exacerbation may~     affect limb muscles.~   "
98157|NCT02282423|"~     The goal of this study is to understand how and why insulin resistant individuals respond~     differently to exercise as compared with insulin sensitive individuals at the skeletal muscle~     and gene expression level.~   "
98158|NCT02282410|"~     Based on the successful pioneer work of Dr Nilsson and her colleagues in Sweden that started~     in the late 1950's, prophylaxis is recommend as the standard of care for boys with severe~     haemophilia by WHO and World Federation of Hemophilia (WFH). The efficacy and safety of~     prophylaxis in preventing bleeds and arthropathy in patients with hemophilia has been~     confirmed in well-designed clinical studies.To keep the factor level above 1%, the standard~     dosage for patients with severe hemophilia A is 20-40 Units /kg/infusion (average 30 Units~     /kg) every other day or three times a week. This dosage has a very high consumption of~     factor, up to 5000-6000 international unit(IU)/kg/year. The high consumption of factor and~     cost present a major barrier to use the standard prophylaxis in many countries particularly~     in the developing world.~      But after the Recombinant Human Coagulation Factor VIII for injection (ADVATE) Patient~     Assistance Program(Golden Key) was launched in 24 Apr 2014 in Nanjing China, the~     affordability of patients was solved and many patients will get more chance to receive~     standard prophylaxis.~      This study is designed to evaluate the Annual Bleeding rate (ABR), joint health outcomes and~     QoL outcomes in subjects using standard prophylaxis under the conditions of routine practice.~   "
98159|NCT02282397|"~     Evaluate if addition and use of real time continuous glucose monitoring (RT-CGM) improves~     glycemic outcome of patients using multiple daily injections (MDI) and self monitoring blood~     glucose (SMBG) testing, who are not at target glycemic control.~   "
98160|NCT02282384|"~     The proposed pilot study will provide needed data to establish the feasibility of a~     conducting a large randomized controlled trial as to the effectiveness of the use of~     oseltamivir early in the course of influenza in outpatients with chronic pulmonary disease.~   "
98161|NCT02282371|"~     This is a phase 1b study, which means that the purpose of the study is to establish the~     maximum dose of a pill drug called BYL719, when given with a standard treatment for patients~     with head and neck squamous cell cancer.~   "
98162|NCT02282358|"~     The purpose of this study is to learn if the study drug mocetinostat can slow the progression~     of cancer in people who have a mutation in CREBBP or EP300 in the genetic makeup of their~     cancer. The potential side effects of mocetinostat will also be studied.~   "
98163|NCT02282345|"~     The goal of this clinical research study is to learn if talazoparib can help to control~     breast cancer that has a BRCA mutation (genetic change). The safety of talazoparib will also~     be studied.~      This is an investigational study. Talazoparib is not FDA-approved or commercially available.~     It is currently being used for research purposes only. The study doctor can explain how the~     study drug is designed to work.~      Up to 20 participants will be enrolled in this study. All will take part at MD Anderson.~   "
98164|NCT02282332|"~     The Impact of Ticagrelor on Coronary Atherosclerotic Lipid Pool and Inflammation Assessed by~     Near-Infrared Spectroscopy study will evaluate whether ticagrelor leads to a 20% reduction in~     the LCBI with NIRS/IVUS suggesting coronary plaque stabilization and reduced inflammation in~     patients already on long-term statin therapy undergoing non-urgent PCI. It is hypothesized~     that the treatment with ticagrelor following PCI will lead to a significant 20% reduction in~     the lipid pool as measured by NIRS/IVUS at follow-up when compared with baseline imaging,~     suggesting a reduction in inflammation and stabilization of the lipid core in atherosclerotic~     lesions not treated during the index procedure.~   "
98165|NCT02282319|"~     The primary objective of this double blind randomized study is to determine the effect of~     dexmedetomidine on onset and duration of the sensory and motor block and on the influence on~     bladder function after spinal anesthesia with chloroprocaine. Our primary hypothesis is that~     sensory block will significantly be prolonged by dexmedetomidine administered by both the~     spinal and the intravenous route. The investigators do not expect a significant difference in~     motor block duration between intravenous or spinal administration. Secondary outcomes are~     micturition problems, duration of analgesia and the occurrence of side effects such as~     sedation and hypotension.~   "
98214|NCT02281669|"~     Cutaneous leishmaniasis (CL) is endemic in Israel and is caused by Leishmania major or~     Leishmania tropica. CL is usually a benign disease and limited to the skin. One of the local~     treatment available is intralesional (IL) Pentostam injection. During the current study the~     investigators will monitor the adverse effects of this treatment and will follow up the~     recovery of the lesions after Pentostam injections.~   "
98166|NCT02282306|"~     There has been a dramatic rise in opioid overdose (OOD) deaths in recent years. Attempts to~     ameliorate the problem have largely focused on increasing the accessibility of naloxone, an~     opioid antagonist that is effective in OOD reversal. Individuals who have experienced a~     non-fatal OOD are at risk for additional overdoses and yet there are no interventions that~     specifically target this high-risk population. To address this gap, the investigators have~     developed the Tailored Telephone Intervention delivered by Peers to Prevent Recurring Opioid~     Overdoses (TTIP-PRO). The overall goal of the present study is to conduct a pilot evaluation~     of the TTIP-PRO. The research literature suggests the need for an intervention targeting~     patients experiencing a non-fatal OOD.~   "
98167|NCT02282293|"~     This is a double-blinded, randomized controlled trial of 200 HIV-infected pregnant women~     living in Tororo, Uganda, an area of high malaria transmission. HIV-infected pregnant women~     between 12 and 28 weeks gestation will be randomized to receive enhanced malaria~     chemoprevention with monthly dihydroartemisinin-piperaquine (DP) versus monthly DP placebo.~     Their HIV-exposed children will receive the same prevention regimen from 2 to 24 months of~     age to which the mothers were randomized. All women will receive daily~     trimethoprim-sulfamethoxazole (TS) throughout the study per Uganda Ministry of Health~     guidelines. Children will also receive daily TS from 6 weeks to 24 months of age. TS will be~     considered a study drug only in infants and children beginning 6 weeks after cessation of~     breastfeeding and upon exclusion of HIV infection. Women and their children will be followed~     for 36 months after delivery. In a subset of the study population, the investigators will~     conduct an intensive pharmacokinetic study that will evaluate pharmacokinetic exposure of DP~     and EFV. The investigators will also measure HIV-related outcomes among the women enrolled in~     the study. The investigators will test the hypothesis that for HIV-infected mothers and~     HIV-exposed infants, that enhanced versus standard malaria chemoprevention in HIV-infected~     pregnant women and their children will reduce the incidence of malaria among children from 0~     to 24 months of age and improve the development of naturally acquired antimalarial immunity.~   "
98168|NCT02282280|"~     Observation of the effects of an administration of prilocaine chlorhydrate hyperbare in~     rachianesthesia among a general surgical population.~   "
98169|NCT02282267|"~     This study was proposed to validate the efficacy of gefitinib as first-line therapy in~     advanced lung adenocarcinoma with EGFR mutation determined by plasma cf-DNA.~   "
98170|NCT02282254|"~     Closed-loop strategy is composed of three components: glucose sensor to read glucose levels,~     insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required~     insulin dosages based on the sensor's readings. A dual-hormone closed-loop strategy would~     regulate glucose levels through the infusion of two hormones: insulin and glucagon.~      The main objective of this project is to compare the efficacy of single-hormone and~     dual-hormone closed-loop strategy to regulate overnight glucose levels in a in-patient study~     in type 1 diabetes adults with hypoglycemia unawareness and documented nocturnal~     hypoglycemia.~      The investigators hypothesized that dual-hormone closed-loop strategy is more effective in~     regulating overnight glucose levels compared to single-hormone closed-loop strategy.~   "
98171|NCT02282241|"~     Delirium is a common complication of illness especially among the elderly with serious~     sequelae including increased mortality, morbidity and length of stay. This neuropsychiatric~     emergency has key features including acute onset, fluctuating level of consciousness, poor~     attention and cognitive deficits with a presentation which may include hallucinations and~     delusions.~      A critical precipitating and maintaining feature of delirium is disrupted sleep. Melatonin is~     a widely available natural health product with evidence in normalizing circadian rhythms and~     sleep. There is also preliminary evidence that melatonin can be used to prevent the~     development of delirium in hospitalized patients. We hypothesize that daily administration of~     melatonin (1.5mg) in the evening, beginning at first admission to hospital and continuing for~     14 days, will lead to decreased rates of delirium compared to placebo-treated comparison~     subjects.~   "
98172|NCT02282228|"~     An open study evaluating the sensitivity and specificity of a microwave-based device,~     Medfield Strokefinder MD100, to detect chronic subdural hematoma, by comparing measurements~     on patients recruited for surgery of chronic subdural hematoma to an age- and gender-matched~     group of healthy volunteers.~   "
98173|NCT02282215|"~     The purpose of the study is to explore the safety and efficacy of CLT-008 as an extra~     supportive care measure after induction chemotherapy for patients with acute myeloid leukemia~     (AML).~   "
98174|NCT02282202|"~     The purpose of this study is to evaluate the safety and efficacy of four times daily Positive~     Expiratory Pressure (oPEP) (Aerobika ®) maneuvers over three weeks in individuals with~     bronchiectasis and chronic obstructive pulmonary disease (COPD) with chronic sputum~     production. The investigators hypothesize that four times daily positive expiratory pressure~     using the Aerobika ® will significantly improve dyspnea, movement of mucus, St. George's~     Respiratory Questionnaire (SGRQ) score, and six-minute walk distance (6MWD) after three weeks~     of four times daily administration.~   "
98175|NCT02282189|"~     The purpose of this study is to evaluate the safety and efficacy of four times daily~     oscillatory Positive Expiratory Pressure (oPEP) (Aerobika ®) use over 4 weeks in individuals~     with stable chronic obstructive pulmonary disease (COPD). The investigators hypothesize that~     daily oPEP use will significantly improve St. George's Respiratory Questionnaire (SGRQ)~     score, six-minute walk distance (6MWD) and forced expiratory volume in one second (FEV1)~     after four weeks of four times daily administration.~   "
98176|NCT02282176|"~     The aim of the TINN2 study is to evaluate the efficacy of azithromycin in prevention of~     bronchopulmonary dysplasia in preterm neonates.~   "
98177|NCT02282163|"~     Safety and Efficacy Study in pediatric subjects aged 9 to 17 years of age with suboptimal LV~     EBD on non-contrast 2D echocardiography. Imaging conditions will represent those in routine~     clinical practice and will include LV EBD with harmonic imaging modality.~   "
98324|NCT02280226|"~     Former studies revealed a distinct pattern of changes in circulation during deliberate apnea.~     Blood pressure rises significantly often accompanied by bradycardia. Further studies~     confirmed a massive increase of total vascular resistance as it also happens in shock to~     maintain perfusion of heart, lung and brain. This study is to determine the exact alterations~     of the cardiac function during this reaction, show the redistribution of blood volume in~     apnea and evaluate possible longterm effects on the central nervous system caused by repeated~     apnea via magnetic resonance imaging.~   "
98178|NCT02282150|"~     Despite optimized hydrocortisone replacement regimes, many patients with adrenal~     insufficiency (AI) suffer from impaired quality of life (QoL). Characteristically, patients~     report high fatigue levels at certain times during the day. A modified-release hydrocortisone~     has been shown to improve QoL, particularly fatigue, in patients with primary AI. However, it~     is unknown, if the same effect can be observed in patients with secondary AI. Further, no~     studies have evaluated the effect, taking into account the diurnal variation of fatigue. A~     novel survey method termed Ecological Momentary Assessments (EMA) has the potential to~     provide reliable measurements of diurnal variations in patient-reported outcomes, such as~     fatigue. We will compare the effect of modified-release compared to conventional~     hydrocortisone on fatigue in patients with secondary AI due to pituitary disease, and hereby~     assess the feasibility of EMA as outcome in future large-scale randomised clinical trials~     (RCTs).~   "
98179|NCT02282137|"~     Single center, Prospective, Phase II expanded access clinical studies of 68Ga-PSMA~     (ProstaMedix TM) used for diagnosis and management of patients with prostate cancer.~   "
98180|NCT02282124|"~     The aim of this study is to investigate the effectiveness of the program in patients after~     renal transplantation using a randomized controlled trial design. Physical, behavioural, and~     clinical outcomes will be measured at baseline before randomization then 8 and 12 months~     later.~   "
98181|NCT02282111|"~     This is a single-blinded randomized control trial trying to compare the effectiveness of~     diagnosis between two techniques employed in tissue sampling for subepithelial tumors (SETs)~     of the gastrointestinal tract. Over 2 years, patients having SET will be randomized to either~     get the EUS-guided core needle biopsy (EUS-CNB) or EUS-guided single-incision with needle~     knife (SINK) technique. This is of grave importance because the diagnosis of the myriad types~     of SETs is made histologically requiring a good sample.~   "
98182|NCT02282098|"~     The purpose of this study is to determine the feasibility of performing a randomized~     controlled trial to investigate the efficacy of an anti-inflammatory drug, colchicine, at~     reducing well validated markers of thrombosis (D-dimer) and inflammation (hs-CRP).~   "
98183|NCT02282085|"~     This study compares aripiprazole once-monthly injection to standard of care oral~     antipsychotic medication in non-adherent outpatients with schizophrenia to see which~     treatment helps people take their medicine more regularly and have more positive outcomes.~      It is hypothesized that non-adherent schizophrenia outpatients receiving aripiprazole~     once-monthly will be more likely to respond and have lower symptom severity over 3 months of~     treatment than those receiving standard of care oral antipsychotics.~   "
98184|NCT02282072|"~     The purpose of this study is to verify efficacy and safety of a bilateral deep brain~     stimulation (DBS) of the Nucleus accumbens (NAc) as a treatment option for severe opioid~     addiction.~   "
98185|NCT02282059|"~     This study is a multi-center, prospective, non-interventional (NI) study evaluating the~     safety and efficacy of sunitinib in Chinese patients with progressive, unresectable, advanced~     or metastatic well-differentiated, pancreatic neuroendocrine tumors(pNET). 100 adults with~     progressive advanced or metastatic well-differentiated unresectable pNET will be recruited in~     China hospitals. Each subject will be followed up overall survival (OS) time or the date of~     withdrawal and subjects who remain alive after study completion will have their OS time~     censored on the last date known to be alive. Eligible subjects will be enrolled to receive at~     least one dose of sunitinib orally at 37.5 mg once a day on a continuous daily dosing regimen~     (CDD) or dosage modification is based on daily clinic practice. Subjects will be treated~     until disease progress, unacceptable toxicity, withdrawal from the study at their own~     request, or until the final analysis for the study is performed. The NI study will capture~     observations that will be used for evaluating the safety profile of sunitinib, including:~     subject demographics, medical history and medications. Safety assessments, treatment data and~     any other laboratory examination results, which were done according to routine clinical~     practice, will be collected at all visits.~   "
98186|NCT02282046|"~     This study is designed to understand the impact of glycemic control in patients with type 2~     diabetes on dental implants under long-term function. It is hypothesized that poor glycemic~     control will not have significant effects on implant-related outcomes over longer periods of~     time.~   "
98187|NCT02282033|"~     The purpose of the study is to evaluate the safety and performance of the Moderato System by~     implanting the Moderato pacemaker in patients who require a dual chamber pacemaker, and who~     also have hypertension, in order to reduce their blood pressure.~   "
98188|NCT02282020|"~     Comparison of olaparib vs. physician's choice of single agent standard of care non-platinum~     based chemotherapy in patients with germline Breast Cancer susceptibility gene (gBRCA)~     mutated ovarian cancer who have progressed at least 6 months after the last platinum based~     chemotherapy. Patient should have received at least 2 prior lines of platinum based~     chemotherapy. The aim of the study is to assess the efficacy and safety of olaparib tablets.~   "
98189|NCT02282007|"~     More and more people suffer from stress-related illness and ailments that can greatly affect~     the individual's experienced quality of life and sense of coping since pain, physical, mental~     and social functioning are closely linked. Many of these people will seek primary care for~     help, and thus be referred to the Norwegian psychomotor physiotherapy (NPMP) performed by~     physiotherapists in primary care.~      Data shows that for the first three months of 2009, 42% of patients were referred to NPMP had~     a musculoskeletal diagnosis as the first diagnosis, often in the form of long-term and~     comprehensive pain problems. Many of the patients also had emotional difficulties, but~     without being diagnosed with mental illness. 23% of patients who were referred to NPMP had a~     psychiatric diagnosis as the first diagnosis. The full range of psychiatric diagnoses are~     represented, but the majority of patients were treated for anxiety and depression.~      The investigators want to let people who have had NPMP treatment to consider what effect the~     treatment has given, measured by separate registrations of quality of life, pain, physical,~     mental and social functioning.~   "
98325|NCT02280213|"~     Comparison of four laryngoscope blades (Miller, Macintosh, Phillips and Wis-Hipple) for~     infant intubation during resuscitation with and without chest compressions.~   "
98326|NCT02280200|"~     The primary aim of this study is to investigate the effect of an ankle foot orthoses (AFO) on~     the primary outcome of peak walking time (PWT) in patients with peripheral artery disease~     (PAD).~   "
98190|NCT02281994|"~     The hypothesis of this study is that PEMF treatment will improve odontoid fracture healing,~     compared with standard conservative care, in subjects 50 years of age and over diagnosed with~     Type II odontoid fractures, and this effect will be evident by 6 months post-injury. Subjects~     will be assessed for the presence of a Type II odontoid fracture by X-ray, MRI and CT scan.~     Subjects meeting eligibility criteria will be randomized in a 2:1 ratio (active: placebo~     control) to either the active or control device for 4 hours a day for 6 months. X-rays will~     be collected at 6 weeks, and at 3, 6 and 12 months to assess the fracture healing process,~     with flexion-extension x-rays collected at 3, 6 and 12 months. A CT scan will be performed at~     6 months to confirm healing. Quality of Life measures (SF-36, VAS neck pain scale, NDI) will~     be collected at all visits (6 weeks, 3, 6 and 12 months). Study subjects will receive either~     an active Orthofix Cervical-Stim Model 2205OD or an inactive (placebo) Orthofix Cervical-Stim~     Model 2205OD device.~   "
98191|NCT02281981|"~     Arterial Stiffness: As a recognized independent indicator of cardiovascular risk, maintaining~     low levels of arterial stiffening is important to cardiovascular health. Increases in~     arterial stiffening results in elevated systolic and mean pressure and it is correlated with~     various cardiovascular conditions such as left ventricular hypertrophy, ischaemic heart~     disease, and myocardial infarction. In contrast, decreased arterial stiffness improves~     ventricular-vascular coupling, ejection fraction, and cardiac output. Arterial stiffness is~     linked to inflammation and oxidative stress. Both inflammation and oxidative stress are~     elevated during DOMS (delayed onset muscle soreness), a state brought on by muscle damage~     often incurred during strenuous exercise. Recent studies have shown that a single bout of~     eccentric exercise can produce acute arterial stiffness during recovery. However,~     anti-oxidants/anti-inflammatories may be effective in reducing the extent of damage by~     decreasing oxidation and inflammation. Curcumin is a powerful antioxidant that could act as~     an anti-inflammatory and diminish the effects of the downhill run. In addition, eccentric~     damage generates a prophylactic protection lasting up to six weeks. The nature of the~     downhill run is primarily eccentric in nature. Therefore, repeated bouts may have diminished~     DOMS development. Any reduction in stress by either the prophylactic repeated bout effect or~     the Curcumin supplement, should attenuate the increase in arterial stiffness due to the~     reduction in inflammation.~   "
98192|NCT02281968|"~     The purpose of this study is to investigate if it is possible to decrease opioid consumption~     in patients undergoing ankle fracture surgery by providing scheduled doses of nonsteroidal~     inflammatory drugs (NSAIDs). This is a prospective, randomized, double-blinded, placebo~     controlled study with two groups of patients: one getting NSAIDs to take at regularly~     scheduled times plus a traditional prescription for opioid medication and one receiving the~     traditional prescription for opioid medication and a placebo. Patients will be assigned to a~     group from a computer-generated program. Neither the patients nor their doctors or nurses~     will know what group they are in, only the pharmacist will have that information. Patients in~     both groups will have the opportunity to take opioid medications if the pain becomes~     unmanageable.~   "
98193|NCT02281955|"~     The purpose of this research study is to learn about the effectiveness of using~     lower-intensity radiation and chemotherapy to treat human papillomavirus (HPV) associated~     low-risk oropharyngeal and/or unknown primary squamous cell carcinomas of the head and neck.~     The cure rate for this type of cancer is estimated to be high, > 90%. The standard treatment~     for this cancer is 7 weeks of radiation with 3 high doses of cisplatin. Sometimes surgery is~     performed afterwards. This standard regimen causes a lot of side effects and long term~     complications. This study is evaluating whether a lower dose of radiation and chemotherapy~     may provide a similar cure rate as the longer, more intensive standard regimen. Patients in~     this study will receive 1 less week of radiation and a lower weekly dose of chemotherapy.~   "
98194|NCT02281942|"~     Low self-control has been associated with a number of unhealthy behaviors with low treatment~     success. Alternative non-pharmacological approaches have the potential for enhancing~     self-control. This pilot study will investigate if the practice of yoga and/or health and~     wellness education improve self-control in the context of nicotine addiction, and will set~     the stage for larger clinical trials using behavioral interventions to supplement or replace~     existing treatments and increase the rates of recovery from disorders in which low~     self-control is a susceptibility factor.~   "
98195|NCT02281929|"~     Treatment of reference of severe alcoholic hepatitis is based on corticosteroids, given for~     28 days. However, about 25-35% of patients do not take benefit from this treatment and die~     within the 6 months following the diagnosis. Numerous trials have evaluated the impact of~     several strategies in association with corticosteroids. None of them has shown an improvement~     in survival (primary endpoint) as compared to corticosteroids alone.~      The project is based on an approach never tested in a randomized controlled trial in severe~     alcoholic hepatitis, targeting the group of patients at high risk of death (25-35% at 2~     months). This approach is based on animal and human studies.Antibiotics are effective in~     animal models and in other circumstances characterized by liver failure such as~     gastrointestinal bleeding related to portal hypertension. The interest of studying this~     population is emphasized by the frequency of infections in these critically ill patients.~     Antibiotics will be administered before the development of any infection, as it is likely~     that these patients present with mesenteric bacterial adenitis without systemic signs of~     infection. Primary endpoint will be 2-month survival as most deaths occur within 60 days and~     treatment is given for 30 days.~   "
98196|NCT02281916|"~     This multicenter phase 2 clinical trial is designed to assess safety of P28GST (protein 28 Kd~     glutathion S Transferrase), aiming to control inflammation in moderate Crohn's Disease (CD),~     before or after intestinal resection surgery. P28GST is a parasite enzyme molecule from~     Schistosoma with potent immunogenic and anti-oxidant properties. Based on experimental~     evidence of its anti-inflammatory properties, the investigators hypothesized that~     administration of P28GST could protect against recurrence after intestinal resection surgery~     in CD.~   "
98197|NCT02281903|"~     The aim of this study was to compare the TrueCPR feedback device (with metronome) to standard~     basic life support (BLS) in terms of the quality of single rescuer pediatric resuscitation.~     Therefore, our hypothesis was that there would be no difference between both CPR methods in~     terms of chest compression quality parameters.~   "
98198|NCT02281890|"~     Neonatal sepsis is an important determinant of adverse neurodevelopmental outcome. The~     investigators seek to investigate whether neurodevelopmental outcome following neonatal~     sepsis differs according to whether or not the diagnosis is confirmed by culture. In a~     secondary analysis of all 3493 infants included in the International Neonatal Immunotherapy~     Study (INIS) randomized controlled trial of intravenous immunoglobulin for neonatal sepsis,~     the investigators will evaluate neurodevelopmental outcomes according to whether or not the~     sepsis was culture-proven. The primary outcome is death or major disability at two years. In~     secondary analyses the investigators will determine neurodevelopmental outcomes according to~     the causative organism identified. Greater understanding of the impact of culture-positivity~     on long-term outcomes in the setting of clinical neonatal sepsis is essential to better~     inform parents about the future prospects of their child and to guide patient follow-up.~   "
98199|NCT02281877|"~     The overall goals of this work are: 1) to elucidate alterations in gene expression and~     downstream protein synthesis 2 weeks after Total Knee Arthroplasty (TKA) to better explain~     quadriceps muscle atrophy after TKA and 2) understand the mechanisms responsible for improved~     maintenance of muscle strength with Neuromuscular Electrical Stimulation (NMES) utilization.~     Furthermore, this investigation seeks to expand previous findings regarding attenuation of~     strength and functional performance deficits with NMES application to better understand how~     altered gene expression influences muscle function.~   "
98200|NCT02281864|"~     Children who are hospitalized are especially vulnerable to the effects of tobacco use and~     dependence among their caregivers, and they are more likely to be exposed than children who~     are not hospitalized. Hospitalization is an important teachable moment for health care~     providers to intervene with tobacco dependent parents, and help them reduce their child's~     exposure, potentially improving outcomes after hospitalization, and their future health.~     Understanding the best way to approach and intervene with these families will provide the~     investigator with the necessary information to create a sustainable intervention that can be~     disseminated to hospitals across the country that provide pediatric care, and to ultimately~     make a significant improvement in the health of children.~   "
98201|NCT02281851|"~     This study will investigate whether increased habitual intake of antioxidant supplements~     effects the concentration of endogenous antioxidants, the response of antioxidants to~     exercise, and differences in oxidative damage compared to a non-supplemented group.~   "
98202|NCT02281838|"~     The vast majority of intracerebral hemorrhage (ICH) patients present with elevated blood~     pressure(BP). Management of BP is controversial with two competing rationales. There is some~     evidence that hyperacute treatment may improve outcomes by reducing the rate of hematoma~     expansion. Physicians have been reluctant to reduce BP early after ICH onset, fearing reduced~     cerebral blood flow (CBF) will increase ischemia and increase the risk of further damage.~     Other confounding mediators to further ischemic injury following ICH include increased~     platelet activity, withdrawal of antithrombotic therapy, endothelial dysfunction,~     inflammation and hypercoagulability.~      This study is phase II of the ICH-ADAPT study. The investigators hypothesize that aggressive~     antihypertensive therapy will alter the natural history of heamatoma growth, improving~     outcomes after Intracranial Hemorrhage (ICH). The previous phase I ICH-ADAPT study has~     established the safety of early BP treatment.~      The investigators have designed a phase II study in which ICH patients are randomized to~     aggressive versus conservative BP treatment using a deferred consent procedure. An adaptive~     randomization will be used to treat BP to < 140 mmHg SBP or < 180 mmHg SBP. Treatment must be~     implemented as soon as possible after radiological confirmation of diagnosis.~     Antihypertensive therapy must begin within 6 hours of symptom onset. The patient will be~     re-imaged 24 hours later. The patient will have continuous non-invasive BP and heart rate(HR)~     monitoring for a minimum of 24 hours. Antihypertensive drug use and dosage will be recorded~     with BP and HR. Patients will be monitored regularly until study completion. MRI's will be~     done at 48 hours, day 7 and day 30. This imaging will help to detect ischemic changes that~     may occur. Blood will be collected at the same time as the MRI. Blood analysis will be done~     to possibly identify biomarkers that may be putative mediators of ischemic injury in ICH~     patients.~   "
98203|NCT02281825|"~     The present study will explore a new approach to ongoing evaluation and monitoring of~     fluctuations in personality traits via commercial video games. The aim of this longitudinal~     study is to examine the influence of everyday life event on video games performance as a~     function of individual differences in gaming behavioral patterns. focusing on the ongoing~     performance vacillations of the patient on commercial video games will offer insights in to~     possibly new generation of real time assessment medium of ongoing behavior.~   "
98204|NCT02281812|"~     Background/Main objective: Radiofrequency ablation (RFA) is a minimally invasive procedure~     widespread accepted in the treatment of different tumors, especially in the liver but its~     benefit is not yet well-known in breast cancer.~      Our main objective is to evaluate the usefulness of RFA in < 2cm malignant breast tumors to~     reduce the proportion of positive margins.~      Methodology: The investigator propose a single-center, single-blind, phase I and II~     randomized controlled trial. Phase I:Security of the cool-tip cluster electrode assessing the~     potential adverse effects in three stages: initial,intermediate and final. Phase II:~     Randomized clinical trial, 2 parallel groups with 37 patients in each one.~      Experimental group: percutaneous RFA previous to conventional lumpectomy. Control group:~     conventional surgery with lumpectomy. The number of positive margins in both groups, and the~     need of extending margin resection will be assessed intraoperatively. Inclusion criteria:~     women >40 years, infiltrating ductal breast carcinoma by biopsy. The tumor must be unique,~     visible by ultrasound, smaller than 2cm and located > 1 cm from the chest wall and the skin.~     Patients will be followed up for a period of two years to assess cosmetic result, short -term~     and long -term complications and recurrences.~      Expected results: The cool-tip (cluster) ablation method reduces by at least 30% the risk~     of intraoperative extensions for positive margins during lumpectomy compared to conventional~     surgery in breast tumors with a diameter < 2 cm.~      Therefore this procedure may reduce the risk of second surgeries and the removed volume of~     tissue.Consequently the final cosmetic result should be improved.~   "
98215|NCT02281656|"~     Ulnar nerve compression at the elbow is a common problem and can significantly affect hand~     function in severe cases. The current, standard treatment is Ulnar nerve decompression with~     or without transposition (moving the ulnar nerve to a site where there is less compression).~     In severe compression, the clinical results after this surgery are typically poor. Distal~     transfers of functioning nerves (at the level of the wrist) to the compressed ulnar nerve~     (anterior interosseous nerve to ulnar motor fascicles) have been suggested to supercharge~     or augment hand muscles while nerve axons regenerate from the level of the elbow after~     decompression/transposition. In fact, this treatment is becoming widely adopted without clear~     evidence that it changes outcomes. The investigators propose to prospectively compare the~     effectiveness of ulnar nerve decompression/transposition versus decompression/transposition~     and distal nerve transfer.~   "
98205|NCT02281799|"~     Azathioprine (AZA) and its metabolite 6-mercaptopurine (6-MP) were developed over 50 years~     ago by Gertrude Elion and George Hitchings and were initially used clinically in the~     management of childhood leukemia and organ transplantation.~      The first case report of 6-MP use in inflammatory bowel disease (IBD) was from 1962 , and~     since then the use of thiopurines has been well established in the management of moderate to~     severe IBD.~      Thiopurines offer an inexpensive and effective treatment option for maintenance of remission~     of IBD in comparison to biological agents which may be 30 times more expensive .~      Although 50-60% of IBD patients respond to thiopurines, a significant proportion of patients~     will not tolerate them due to various adverse effects . The adverse effects of thiopurines~     may be dose related, patient related or idiosyncratic.~      The immunosuppressive effects of thiopurines also increase the rates of opportunistic~     infections.~      Thiopurines are also associated with a higher rate of malignancies, particularly a malignant~     Burkitt-like lymphoma, related to Epstein-Barr virus infection . Other adverse effects of~     thiopurine relate to allergic phenomenon.~      An idiosyncratic adverse effect of thiopurine use is acute pancreatitis (AP).~      Acute inflammation of the pancreas defined by INSPPIRE criteria:~      requiring 2 of:~        1. Abdominal pain compatible with AP~        2. Serum amylase and/or lipase ≥ 3 times upper limits of normal~        3. Imaging findings of AP~      Drug induced AP is the assumed diagnosis when no other cause of AP can be found, the patient~     is taking a drug known to be associated with AP, and symptoms resolve after drug~     discontinuation. If pancreatitis re-occurs on re-exposure, the drug is definitely considered~     the cause.~      While drugs are considered a rare cause of AP and most cases are mild and self limited ,~     there is an 8 fold higher risk of AP in IBD patients treated with AZA . Thiopurine induced AP~     is usually detected within 4 weeks of starting treatment.~      However in the case of thiopurine induced AP, there has been no clear understanding of the~     mechanism.~      Thiopurine induced AP is generally considered an indication to cease thiopurine therapy, due~     to the assumed risk of recurrence of AP on reintroduction.~      There exists several case reports and anecdotal evidence that reintroducing thiopurines~     following an assumed thiopurine associated AP can be well tolerated.~      The investigators hypothesize that AZA and/or 6-MP can be safely reintroduced in the~     management of IBD patients following thiopurine-induced pancreatitis.~      If in the past the patients were treated with AZA, they will now be commenced on 6-MP, and if~     in the past they were treated with 6-MP, they will be commenced on AZA.~   "
98206|NCT02281786|"~     This is a single center, randomized, investigator/subject blind, single ascending dose,~     placebo-controlled, parallel study that will evaluate the safety, tolerability and~     pharmacokinetics of RO6926496 in healthy male participants. The dose escalation is adaptive~     in nature. It is planned to enroll 48 subjects in 6 cohorts. The anticipated total duration~     of the study is 16 weeks.~   "
98207|NCT02281773|"~     The objective of the study is to investigate the efficacy, safety and tolerability of four~     different doses of BI 409306 once daily compared to placebo given for 12 weeks in patients~     with schizophrenia on stable antipsychotic treatment.~   "
98208|NCT02281760|"~     Erdheim-Chester Diseases (ECD) is a very rare non-Langerhans cell histiocytosis of unknown~     origin and pathogenesis. It has been reported mainly in adult males over the age of 40 years,~     although cases have been reported in females as well. Children are rarely affected. Mutation~     of the BRAF gene, specifically BRAFV600E, has been recently identified in 50% of Erdheim~     Chester lesions in a French cohort. This somatic mutation is believed to be the driver~     mutation in positive cases. The clinical characteristics of ECD range from asymptomatic to~     multisystemic involvement; longitudinal progression and natural history are becoming better~     understood. ECD commonly affects the bones, kidneys, retroperitoneal space, skin and brain.~     If untreated, the disease progresses rapidly, causing fatal outcomes due to severe lung~     disease, chronic renal failure, cardiomyopathy and other complications. The diagnosis of ECD~     relies upon imaging studies and specific pathologic findings in biopsies of affected organs,~     i.e., fibrosis and infiltration of tissues with foamy histiocytes, lymphocytes, and plasma~     cells. Immunohistochemistry reveals cells positive for CD68 and CD163 and negative for CD1a,~     with 20% positivity to S-100. There is no standard treatment for ECD, although chemotherapy,~     radiation, stem cell transplantion, alpha-interferon, anakinra, imatinib and sirolimus have~     been proposed. The recent discovery of the BRAFV600E mutation in several ECD patients has~     opened a new area for treatment options. Vemurafenib, an FDA approved BRAF inhibitor for the~     treatment of patients with metastatic or unresectable melanoma with the V600E mutation, binds~     to this form of mutated BRAF causing protein inactivation. The use of vemurafenib in patients~     with ECD has been reported in 3 patients who experienced remission of the disease, and is~     currently being studied in the U.S. and Europe as monotherapy. Tumor/disease resistance to~     vemurafenib has occurred in melanoma and other cancers, although it has not been reported in~     patients with ECD. In this protocol, we propose to clinically evaluate ECD patients with the~     BRAFV600E mutation and administer combination therapy with dabrafenib, a BRAFV600E inhibitor,~     and trametinib, an inhibitor of MEK, downstream of BRAF. Screening for possible~     contraindications will be made prior to the administration of the first dose. With this~     trial, we will determine the safety, tolerability, and efficacy of dabrafenib and trametinib~     in patients with ECD who harbor the BRAFV600E mutation. Dabrafenib 150mg will be given twice~     daily p.o.; trametinib 2mg will be given once daily p.o. Patients will be seen 1 week, 1~     month, 2 months, 4 months, and 6 months, 8 months, 10 months and 12 months to complete a~     oneyear trial.~   "
98209|NCT02281747|"~     Background:~      - Orthopedic procedures are common in the United States. These include joint replacement and~     spine surgeries. Researchers want to study data about these procedures over time. They want~     to see if treatment has gotten better. They also want to find ways to change the care that~     people get before and after they have these procedures. These changes may lower the risk of~     problems people can have during and after treatment. They may also improve people s results.~      Objectives:~      - To study a series of questions about surgery, medicine, treatments, and outcomes for~     orthopedic procedures.~      Eligibility:~      - Data from the U.S. Centers for Medicare and Medicaid Services from 1999 to 2015.~      Design:~        -  Researchers will look at data for people ages 20-100.~        -  No new participants will be used in this study.~        -  The study will last 4 years.~   "
98210|NCT02281721|"~     The purpose of this observational post-marketing registry will be to collect and analyze~     safety, effectiveness, and quality of life outcomes, during and after treatment with the~     Surpass Flow Diverter. Health Economics assessments (cost data) will also be collected and~     analyzed.~   "
98211|NCT02281708|"~     Researchers developed the nomogram which evaluate the risk of recurrence after surgical~     resection, and found that the stage 1 NSCLC patients with more than 104 point of nomogram~     showed similar recurrence rate to the recurrence rate of stage 2 NSCLC patients. Thus those~     stage 1 NSCLC patients at high recurrence rate are considered to show positive effect of~     adjuvant chemotherapy and perform the study to prove this hypothesis.~      Applying the nomogram, the patient scored lower than 104 is categorized into low risk group~     and is to be grouped as the observation group which adjuvant chemotherapy will not be given.~     The high risk group patients (the nomogram scored larger than 104) are randomly divided into~     the treatment group and the observation group. Then, the clinical result on the recurrence~     between the observation group and the treatment group will be compared.~      - Regimen of the adjuvant chemotherapy: The most commonly used 1st line chemotherapy regimen~     which is vinorelbine plus cisplatin will be admitted for 4 cycles. Also the three days before~     and the after the estimated day are permitted as allowance.~      Intravenous administration of vinorelbine (25mg/m2), the 1st and the 8th day of the each~     cycle, every 3 weeks.~      Intravenous administration of cisplatin (75mg/m2), the 1st day of the each cycle, every 3~     weeks.~   "
98212|NCT02281695|"~     The purpose of this study is to determine the differences in oxygenation and decarboxylation~     between two weaning processes.~   "
98213|NCT02281682|"~     A multi-centre randomised controled single blind clinical phase IV trial with the aim to~     determine the most effective treatment in terms of lesion reduction, costs and patient~     satisfaction in treatment of actinic keratosis (AK), when comparing topical treatment with~     photodynamic therapy (PDT), 5% 5-fluorouracil (5-FU) cream, 5% Imiquimod (IMI) cream and~     ingenol mebutate (IM) gel.~   "
98216|NCT02281643|"~     This study will determine the influence of doxycycline treatment against Wolbachia/M.~     perstans on immunity against concomitant mycobacterial infections in healthy M. perstans~     infected individuals. In this regard, the investigators will perform a community-based~     randomized controlled trial (Phase 2a) in Asante Akim North District. A cohort of 200~     participants who are contacts of patients with Tuberculosis or Buruli ulcer, of both sexes~     with no clinical condition requiring long-term medication but connected with Mansonella~     perstans will be investigated for the effect of doxycycline on microfilaria, the immune~     response and development of mycobacterial disease.~   "
98217|NCT02281630|"~     The purpose of this study is to evaluate the efficacy and safety of KWA-0711, and to~     determine its optimal dose in Chronic Constipation (CC) patients.~   "
98218|NCT02281617|"~     Patients experience problems with their memories from a variety of causes. There has been~     much work showing that the use of low tech devices, such as notebooks or diaries, can help~     patients remain independent. More recently, the use of electronic devices, such as digital~     voice recorders or pagers, has proved equally beneficial. Many of functions of memory aids~     could potentially be carried out by a smartphone or tablet using inbuilt functions such as a~     calendar or maps, as well as through downloadable apps, such as medication reminders. The~     investigators have surveyed the investigators patients to show that many of them already own~     smartphones and this number has dramatically increased in the last year. This project aims to~     investigate the feasibility and efficacy of using smartphone and tablet apps as memory aids~     in a clinical setting.~   "
98219|NCT02281604|"~     The purpose of this study is to determine whether the use of 0.2/1.2 microliter in-line~     filter reduces the incidence of severe vasoplegia comparing to the 5 microliter filter.~   "
98220|NCT02281591|"~     Single centre, open-label, randomised study in four parallel groups of healthy volunteers~   "
98221|NCT02281578|"~     The Phase II trial will assess the feasibility, acceptance, safety, pathways, and initial~     effectiveness of a community-based combination HIV prevention intervention among bar-based~     female sex workers in Iringa, Tanzania. Results will inform an appropriately powered Phase~     III RCT as warranted.~   "
98222|NCT02281565|"~     The study evaluates the knowledge, attitude and practice about blood donation among medical~     students and medical staff in Poland.~   "
98223|NCT02281552|"~     This is a 12 week study that will evaluate the efficacy and safety of the 11 mg tofacitinib~     modified release tablet taken once a day in patients with rheumatoid arthritis who continue~     taking methotrexate. Results for the modified release tablets will be compared to the~     efficacy and safety of the 5 mg tofacitinib immediate release tablets taken twice a day in~     patients with rheumatoid arthritis who continue taking methotrexate.~   "
98224|NCT02281539|"~     The goal of the clinical investigation is to reduce phantom limb pain (PLP), painful~     condition affecting 70% of amputees, so as to improve these patients' quality of life.~   "
98225|NCT02281526|"~     Open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with~     moderate hepatic impairment and healthy controls. The trial consisted of a screening visit, a~     treatment phase and a follow-up visit. All subjects were to be treated with study medication~     for 8 consecutive days. Blood and urine were collected for the PK analysis, and safety~     assessments were performed.~   "
98226|NCT02281513|"~     Participants from the Fatigue and Lifestyle Physical Activity and SLE Study will be~     approached to enroll in a 6 week pilot intervention. This study will look at the barriers and~     facilitators to increasing physical activity, improving dietary/nutritional intake, and~     improving sleep.This study will offer support and information for people with SLE to increase~     their physical activity, improve their dietary/nutritional intake, and improve their sleep~     and will utilize a smartphone application to self-monitor changes in these behaviors.~   "
98227|NCT02281500|"~     Multicenter, Prospective, Open-Label, Single-Arm Trial to Evaluate the Pharmacokinetics,~     Efficacy, and Safety of Human Plasma-Derived Fibrinogen (FIB Grifols) in Patients with~     Congenital Afibrinogenaemia~   "
98228|NCT02281487|"~     The purpose of this study is to determine whether a tubectomy during hysterectomy for benign~     gynaecological conditions does not result into a premature menopause.~   "
98229|NCT02281474|"~     This pilot study will test Nilotinib's ability to alter the abnormal protein build up in~     Parkinson disease and Diffuse Lewey Body Disease patients . Patients will receive Nilotinib~     at different doses for 6 months. Patients will then be tested to see if there is change in~     three areas: 1) has the disease symptoms changed. 2) has levels of a specific misfolded~     protein changed in the fluid around their brain and spine. 3) Have inflammatory markers~     changed in the patient's blood and fluid around their brain and spine. If successful, this~     drug could be used to slow down or stop the progression of disorders that involve abnormal~     collection of misfolded proteins. However, the main purpose of this pilot study is to check~     for the safety of using this medication at this level.~   "
98230|NCT02281461|"~     The PrePex is a WHO prequalified medical device for adult male circumcision for HIV~     prevention. The Government of Rwanda was the first country to implement the PrePex and acts~     as the leading Center of Excellence providing training and formal guidelines.~      In support of efforts to scale up male circumcision, readily available data have been applied~     to estimate the potential cost and impact of scaling up medical MC services in Rwanda to~     reach 80 percent of adult, children and newborn males by 2015. Infant and children male~     circumcision ensures that the wound will be healed before sexual activity begins, and thus~     reduces the risk of HIV transmission during healing period.~   "
98231|NCT02281448|"~     Single centre, two-way crossover, randomised, open-label study in 20 healthy female~     volunteers.The volunteers received an oral single-dose of a combined contraceptive containing~     with an oral once daily dose of 1200 mg of BIA 2-093~   "
98246|NCT02281253|"~     The aim of this study was to evaluate the efficacy of a bakery product enriched with dietary~     fibre and L-carnitine on glucose homeostasis and insulin sensitivity in overweight patients~     with or without metabolic syndrome.~   "
98247|NCT02281240|"~     Hemostatic disorders are common and potentially fatal complications in patients undergoing~     hematopoietic stem-cell transplantation (HSCT). Limited data exist on early diagnosis and~     prevention of these complications. The investigators undertook this prospective study to~     determine the incidence, predictor factors, specific pathogenesis, management and survival~     specially for patients with thrombotic and bleeding complication to better improve outcomes.~   "
98232|NCT02281435|"~     It is well known from a range of observational and epidemiological studies that the lifetime~     risk of acquiring HIV among males can be significantly reduced via circumcision by 53%-60%~     and by up to 73% in post-trial observation. Numerous papers on the topic have been published~     over the past two decades to elevate HIV prevention awareness, especially in sub-Saharan~     countries.~      Results from the Decision Makers' Program Planning Tool (DMPPT) models, performed in 2011,~     suggest that scaling up adult voluntary medical male circumcision (VMMC) to reach 80%~     coverage in the 13 countries by 2015 would entail performing 20.34 million circumcisions~     between 2011 and 2015 and additional 8.42 million between 2016 and 2025. Such a scale-up~     would result in averting 3.36 million new HIV infections through 2025. In addition, while the~     model shows that this scale-up would cost a total of US$2 billion between 2011 and 2025, it~     would result in net savings (due to averted treatment and care costs) amounting to US$16.51~     billion.~      To date, there are over 38 million adolescent and adult males in Africa that could benefit~     from male circumcision (MC) for HIV prevention. The challenge Africa faces is how to safely~     scale up a surgical procedure in resource limited settings.~   "
98233|NCT02281422|"~     Open-label, single-dose (BIA 2-093 800 mg tablet), single-centre study in five groups of~     subjects with various degrees of renal function based on creatinine clearance~   "
98234|NCT02281409|"~     The purpose of this study is to find out what effects, good and/or bad, KW-0761, an~     investigational drug, has on the patient and their cancer.~   "
98235|NCT02281396|"~     The purpose of this study is to evaluate the safety of Freeze-dried Rabies Vaccine （MRC-5~     Cell) in healthy humans aged from 10-60 years old, according to the traditional Essen methods~     (1-1-1-1-1) vaccination.~   "
98236|NCT02281383|"~     This is a phase II study. This means that BCG therapy has already been found to be safe in~     humans. The investigators just want to see if using more treatments works better.~   "
98237|NCT02281370|"~     A drug-drug interaction study between eltrombopag and cyclosporine is being conducted to~     support the use of these drugs together in subjects, such as those with severe aplastic~     anemia or immune thrombocytopenia purpura. The primary objective of the study is to evaluate~     the effect of cyclosporine on the pharmacokinetics of eltrombopag. This is a Phase I,~     open-label, randomized, three-period cross-over study in healthy adult subjects. The study~     consists of a screening visit and three treatment periods. All subjects will be randomized to~     receive one of the three treatments in each treatment period separated by washout periods of~     3-10 days. The total duration of a subject's participation in the study from screening to~     final discharge is up to approximately 6 weeks (assuming 3 day washouts between treatment~     periods). Approximately 39 healthy subjects will be enrolled with the goal of completing at~     least 10 subjects per sequence (total 30).~   "
98238|NCT02281357|"~     A Multicentre, Randomized, Double-blind, Parallel Group, Placebo Controlled, Phase 3 Study to~     Evaluate the Efficacy and Safety of Tralokinumab in Reducing Oral Corticosteroid dependent~     Asthma.~   "
98239|NCT02281344|"~     A single-centre, open-label, study using induced blood stage malaria infection to~     characterize the activity of MMV390048 against early Plasmodium falciparum blood stage~     infection.~   "
98240|NCT02281331|"~     As we age we tend to lose muscle mass and strength. These losses contribute to the increased~     incidence of falls and fractures, metabolic diseases such as type 2 diabetes, loss of~     independence and reduced quality of life in the elderly. As the number of seniors increases~     worldwide, it is becoming more and more important to develop strategies to counteract this~     loss of muscle mass and strength, and promote healthy aging. Fortunately, relatively simple~     lifestyle modifications are the most potent defense strategies. Exercises such as weight~     lifting and high-intensity interval exercise (HIIT), which consists of short, repeated bouts~     of vigorous aerobic exercise interspersed with period of rest, are the most effective in~     promoting gains in muscle mass and strength. Additionally, components of foods like whey (a~     protein found in milk), creatine (found in meat), calcium and vitamin D have been shown to~     independently increase strength. In this study, we are looking to determine how much we can~     increase muscle strength in older men who are put on an 12 week exercise training program~     that combines weight lifting and HIIT, and who consume a daily supplement that contains whey~     protein, creatine, calcium and vitamin D.~   "
98241|NCT02281318|"~     This is a multi-centre, placebo-controlled, double-blind, parallel-group study to evaluate~     the efficacy and safety of mepolizumab adjunctive therapy in participants with severe~     eosinophilic asthma on markers of asthma control. The overall intent of the current study is~     to more fully explore the impact of mepolizumab on health-related quality of life (HR-QoL)~     and other measures of asthma control, including lung function.~      Participants who meet the predefined criteria will be randomised to receive either~     mepolizumab or placebo in addition to standard of care asthma treatment. Approximately 780~     participants with severe eosinophilic asthma will be screened to ensure the randomisation of~     544 participants (272 participants per treatment group) into the study.~   "
98242|NCT02281305|"~     Restoring the patency of the coronary vessels and providing the ischemic myocardium with~     reperfused blood can cause additional tissue damage. A key element of ischemia and~     reperfusion (I/R) injury and major determinant of the evolution of damage in the affected~     myocardium is the inflammatory response. The main objective of the study is to evaluate the~     efficacy of colchicine in reducing I/R injury by effectively modulating the inflammatory~     response in the reperfused myocardium.~   "
98243|NCT02281292|"~     The purpose of this study is to evaluate the initial safety of intravitreal (IVT) LKA651 and~     potential for use alone or in combination with Ranibizumab ophthalmic solution (Lucentis®)~     for the treatment of Diabetic Macular Edema (DME) in patients with symptomatic disease.~   "
98244|NCT02281279|"~     This phase I/II trial studies the side effects and best dose of romidepsin and lenalidomide~     when combined with rituximab and to see how well this combination works in treating patients~     with B-cell non-Hodgkin lymphoma that has returned (recurrent) or did not respond to~     treatment (refractory). Monoclonal antibodies, such as rituximab, may block cancer growth in~     different ways by targeting certain cells. Romidepsin and lenalidomide may stop the growth of~     cancer cells by blocking enzymes needed for cell growth. Giving rituximab together with~     romidepsin and lenalidomide may be a better treatment for B-cell non-Hodgkin lymphoma.~   "
98245|NCT02281266|"~     Efficacy and safety of Thymalfasin adjuvant therapy in HBV-related HCC after curative~     resection.~   "
98249|NCT02281214|"~     The identification of driver mutations in the epidermal growth factor receptor (EGFR) as the~     primary oncogenic event in a subset of lung adenocarcinomas led to a model of targeted~     treatment and genetic profiling of the disease. EGFR tyrosine kinase inhibitors (TKIs) confer~     remission in some patients, but use of the EGFR-TKIs is limited to patients with~     adenocarcinomas who have known activating EGFR mutations. And resistance to TKI treatment has~     become an increasingly important cause of treatment failure. Therefore, identification of the~     molecular components involved could lead to the development of effective therapy. Today only~     a limited number of genetic alterations are studied.~      Next Generation Sequencing (NGS) has the potential of becoming an important tool in clinical~     and therapeutic decision-making in oncology owing to its enhanced sensitivity in DND mutation~     detection.~   "
98250|NCT02281201|"~     The purpose of this study is to evaluate efficacy and safety of a Prothrombin Complex~     Concentrate (PCC), BE1116. BE1116 will be used for the rapid reversal of coagulopathy induced~     by vitamin K antagonists in Japanese subjects who require immediate correction of~     international normalized ratio (INR) due to a major bleed or emergency surgery.~   "
98251|NCT02281188|"~     The aim of this registry is to evaluate the incidence, indications and outcomes of patients~     presenting with UTUC in relation to the different treatment modalities used.~   "
98252|NCT02281175|"~     Benzodiazepines (BZD) are widely used to treat anxiety, insomnia, and depression. These drugs~     can have very serious side effects if they are taken over a long period of time. In addition~     to stability, memory, concentration, vigilance, and attention impairments, long-term use of~     BZD is also associated with an increased in hypertension incidence, urinary incontinence,~     coronary artery disease, and renal complications. There are growing evidences that long-term~     BZD use causes physical and psychological dependence as evidenced by the withdrawal syndrome.~      The recommended strategy by physicians to facilitate the withdrawal of BZD is to gradually~     reduce the medication, either by replacing the BZD by another with a longer half-life, or by~     the gradual dose reduction. Unfortunately, the success of such a procedure is low as up to~     80% of people who try to quit, relapse due to the intolerance of withdrawal symptoms.~     Therefore, it is important to find new strategies to overcome the withdrawal difficulties.~      The aim of this study is to test the effectiveness of a novel psychosocial intervention~     called PASSE-65+ to facilitate the benzodiazepine withdrawal in the older users, thus~     providing a new therapeutic tool to physician.~   "
98253|NCT02281162|"~     Schizophrenia and bipolar disorders are major public health problems. The second generation~     anti-psychotic drugs have efficacy for both positive and negative symptoms and a favorable~     risk profile as far as movement disorders. However, these drugs are associated with~     clinically significant weight gain and metabolic effects. The underlying mechanisms of these~     side effects are unclear, however in our preliminary studies with schizophrenic patients on~     atypical anti-psychotic drugs, we found that weight gain and vitamin D deficiency was present~     in about 50% of this population. Given the considerable heterogeneity among the patients on~     atypical anti-psychotics and potential for weight gain in vitamin D-deficient states, we~     propose that patients with schizophrenia who gain weight on atypical antipsychotic~     medications are vitamin D-deficient. This hypothesis will be tested in patients with~     schizophrenia receiving second-generation anti-psychotic drugs for a minimum duration of 4~     months. Specific Aim: We predict that the patients with schizophrenia, who gain weight with~     antipsychotic treatment, are vitamin D-deficient compared to the patients who do not gain~     weight. We will examine circulating levels of serum 25(OH)D, mRNA transcripts and protein~     expression of vitamin D receptor (VDR) and the enzymes, CYP24A and CYP27B, in the white blood~     cells of the subjects and correlate with BMI and the blood levels of leptin and adiponectin.~   "
98254|NCT02281149|"~     Adjuvant radiotherapy after lumpectomy allows a local long-term control of the order 85 to~     95% with a survival rate equivalent to that of the totally mastectomy. The diminution of the~     local recurrence rate after irradiation post- lumpectomy is also associated to a best global~     survival than only the surgery. The adjuvant radiotherapy after partially or totally~     mastectomy for the progressive tumors is a therapeutic standard (Early Breast Cancer~     Trialists' Collaborative Group 2011). The aim of our trial of routine care is to record our~     practices under this breast adjuvant radiotherapy.~   "
98255|NCT02281136|"~     The purpose of this study is to evaluate the potential for systemic exposure of~     aminolevulinic acid (ALA) when applied topically under occlusion, in a maximal use setting in~     patients with multiple actinic keratoses (AK) involving the upper extremities.~   "
98256|NCT02281123|"~     Chikungunya is a viral disease transmitted by mosquitoes whose clinical feature is the early~     joint damage. Approximately 8% of patients have chronic arthropathy resembling to the~     rheumatoid polyarthritis. The EchoCHIK study we propose is in the context of the epidemic in~     Martinique which began in January 2014. It should give a better understanding of arthritis~     and juxtaarticular of CHIK and look for signs that may allow ultrasound predict the evolution~     of chronic arthropathy of CHIK.~   "
98257|NCT02281110|"~     The purpose of this registry is to collect real life information and to document the~     performance and user friendliness of iFR in daily diagnostic practice and treatment~     strategies for MVD patients undergoing cardiac catheterization.~   "
98258|NCT02281097|"~     ﻿Some patients experience high heart rates and symptoms of light-headedness, fatigue,~     headache during standing despite well maintained blood pressure.~      These patient are disabled and can't be in upright position for a longer time. The purpose of~     this study is to test whether electrical stimulation of a nerve through a skin of the ear may~     improve heart rate response and reduce disabling symptoms.~   "
98259|NCT02281084|"~     Evaluate the safety and efficacy of CC-486 in Subjects with Myelodysplastic Syndromes who~     failed to achieve an objective response post iHMA treatment~      Reason for removing the Combo arm: Due to difficulties with dose-finding, the durvalumab plus~     CC-486 combination arm is closed to enrollment~   "
98327|NCT02280187|"~     It is a phase IV, national, multicenter, observational, retrospective study collecting data~     from patient medical files in French spinal centers.~      The aim of the study is to describe the real world use of InductOs in Spine fusion in France.~      Approximately 10 French centers will enroll 400 patients. The retrospective review of records~     will focus on patients who have undergone a spinal fusion surgery. Patient should be~     considered for enrollment if he/she has been treated with InductOs between January 1, 2011~     and 31st December 2012.~   "
98260|NCT02281071|"~     The benefits of microsurgical approaches in periodontal therapy have been described. The main~     focus of this study is to determine if using microsurgical LMCAF technique would improve the~     outcomes of the therapy for the Miller Class III isolated recession-type defects.~      Six months results of this study showed that LMCAF with microsurgical approach offered better~     complete and mean root coverage results over macrosurgical LMCAF technique. The superior~     effect of microsurgical approach on post-operative morbidity can make this technique more~     preferable for the patients who expected comfortable postoperative period.~      This study supports that using the microsurgical aproach with LMCAF procedure significantly~     affects the clinical and patient-centered success of treating Miller Class III isolated typed~     defects.~   "
98261|NCT02281058|"~     Vitiligo is a chronic autoimmune disease with evidence of CTLA-4 involvement. We are~     performing a pilot study for the treatment of new onset or actively progressing vitiligo with~     abatacept to determine if weekly self-injections of medication lead to clinical improvement~     in vitiligo lesions.~   "
98262|NCT02281045|"~     It is not known whether the combination of a heparin-grafted membrane plus citrate-containing~     dialysate is a valid alternative to regional citrate anticoagulation. This is a cross-over~     non-inferiority trial comparing these two anticoagulation strategies~   "
98263|NCT02281032|"~     BACKGROUND Nursing homes are important locations for palliative care. Through comprehensive~     geriatric assessments (CGAs), evaluations can be made of the palliative care needs of nursing~     home residents. The interRAI Palliative Care instrument (interRAI PC) is a CGA that evaluates~     diverse palliative care needs of adults in all healthcare settings. The evaluation results in~     Client Assessment Protocols (CAPs: indications of problems that need addressing) and Scales~     (e.g. Palliative Index for Mortality (PIM)) which can be used to design, evaluate and adjust~     care plans. This study aims to examine the effect of using the interRAI PC on the quality of~     palliative care in nursing homes. Additionally, it aims to evaluate the feasibility and~     validity of the interRAI PC.~      METHODS This study covers phases 0, I and II of the Medical Research Council (MRC) framework~     for designing and evaluating complex interventions, with a longitudinal, quasi-experimental~     pretest-posttest design and with mixed methods of evaluation. In phase 0, a systematic~     literature search is conducted. In phase I, the interRAI PC instrument is adapted for use in~     Belgium and implemented on the BelRAI-website and a practical training is developed. In phase~     II, the intervention is tested in fifteen nursing homes. Participating nursing homes fill out~     the interRAI PC during one year for all residents receiving palliative care. Using a~     pretest-posttest design with quasi-random assignment to the intervention or control group,~     the effect of the interRAI PC on the quality of palliative care is evaluated with the~     Palliative care Outcome Scale (POS). Psychometric analysis is conducted to evaluate the~     predictive validity of the PIM and the convergent validity of the CAP 'Mood' of the interRAI~     PC. Qualitative data regarding the usability and face validity of the instrument are~     collected.~      DISCUSSION This is the first study to evaluate the validity and effect of the interRAI PC in~     nursing homes, following a methodology based on the MRC framework. This approach improves the~     study design and implementation and will contribute to a higher generalizability of results.~     The final result will be a psychometrically evaluated CGA for nursing home residents~     receiving palliative care.~   "
98264|NCT02281019|"~     The purpose of this study is to document indications for cholangioscopy and clinical utility~     of the SpyGlass Direct Visualization System throughout the AMEA (Asia, Middle-East, Africa)~     region when used per standard of practice.~   "
98265|NCT02281006|"~     This study evaluates whether a gel containing sodium thiosulfate deposited via a~     trans-tympanic injection on the round window of the middle ear could reduce the ototoxicity~     caused by the drug Cisplatin among patients with head and neck cancer treated by~     chemoradiation. One ear selected randomly will be treated while the other will serve as~     control.~   "
98266|NCT02280993|"~     To combine Brentuximab Vedotin with Dexamethasone, AraC and Cisplatin (DHAP) chemotherapy in~     patients with Hodgkin lymphoma (HL) refractory to first line chemotherapy or in first relapse~     is expected to induce a significantly higher (metabolic) complete remission (CR) rate prior~     to consolidation with BEAM, as judged by FDG (18F-2-fluoro-2-deoxy-D-glucose~     fluorodeoxyglucose)-PET negativity. This will be compared with published data on DHAP salvage~     only. Increasing the metabolic CR rate prior to consolidation with high dose chemotherapy and~     autologous stem cell transplantation (ASCT) is expected to improve progression free survival~     (PFS) and overall survival (OS).~   "
98267|NCT02280980|"~     Individuals older than 60 years old, discharged after suffering brain stroke with referral to~     the rehabilitation outpatient clinic, will be assessed for orthostatic balance. Patients with~     positive Romberg test are invited to participate in the trial. Participants will be~     randomized to either the current rehabilitation protocol or to an supplemental intervention~     focused on oculomotor and gaze stability exercises to be applied at home for three weeks.~     Participants will be assessed with standardized, validated tools.~   "
98268|NCT02280967|"~     The last ten years sexually transmitted infections (STI) have substantially increased among~     adolescents. STI can lead to individual suffering and have a negative effect on the future~     reproductive health and also increase the need for health care, thus it is important to~     reduce the number of STIs. HPV vaccination is included in the school-based vaccination~     program since 2012, a catch-up vaccination is offered to older girls and young women aged~     13-25. School nurses have a key role regarding information about HPV and HPV vaccine, and the~     school-based vaccination program has a substantial higher coverage rate. Knowledge is an~     important factor associated with attitude to preventive methods against HPV. In previous~     studies the results indicate that young people have low awareness of HPV and the HPV vaccine.~     Interventions can decrease sexual risk taking and influence the intention to receive HPV~     vaccination and increase the use of condom.~      The aim of this study is to increase primary prevention of human papillomavirus (HPV) by~     promoting HPV vaccination and increase condom use among upper secondary students. The aim is~     also to increase the knowledge about HPV, risk and prevention.~   "
98269|NCT02280954|"~     According to the World Health Organization, cancer is a leading cause of death in men and~     women, accounting for 7.6 million deaths (around 13% of all deaths) in 2008. Surgery remains~     the best option for patients presenting with operable Stage I or II cancers, however the five~     year survival rate for these candidates remains at a dismally low. The high rates of~     recurrence suggest that surgeons are unable to completely detect and remove primary tumor~     nodules in a satisfactory manner as well as lingering metastases in sentinel lymph nodes. By~     ensuring a negative margin through near-infrared imagery it would be possible for us to~     improve the rates of recurrence from patients and thus overall survival.~   "
98270|NCT02280941|"~     This study is being done to compare the blood flow measurements obtained with the SPECT and~     PET imaging scans. Measurements such as myocardial blood flow (MBF) and myocardial flow~     reserve (MFR) are analyzed on PET scans. These measurements give the doctors more precise~     information in diagnosing heart problems. SPECT scans, with new camera technology and~     computer software, now have the potential to also give this additional information. The study~     is investigating how well the blood flow measurements from SPECT compared to PET.~   "
98273|NCT02280902|"~     Infections represent the first cause of death and of morbidity in people treated for~     immunologic and inflammatory diseases with corticosteroids, immunosuppressive drugs or~     biotherapy. Epidemiological, clinical, biological and therapeutic determinants of these~     infections are poorly understood. There is no recommendation for the prevention and treatment~     of infections in this particular field.~      Purpose : Recent therapeutic trials evaluating immunosuppressive and biotherapy~     (cyclophosphamide, mycophenolate mofetil, rituximab, belimumab) in the field of immunologic~     and inflammatory diseases have found a risk of severe infection of 7 to 18% during the first~     year after the beginning of the treatment. Thus, the main objective of the study is to~     describe the incidence and risk-factors for infections in people treated with such agents for~     immunologic and inflammatory diseases.~   "
98274|NCT02280889|"~     Congenital melanocytic nevi (CMN) are a quite common congenital disorder. Over years,~     surgical excision was proposed to the patients because transformation into a malignant skin~     tumor (melanoma) was feared. Recent data proof that the risk for malignancy was~     overestimated. Nowadays still a lot of patients express their wish for surgical removal out~     of aesthetic reasons and psychological impacts. Many patients and families experience~     stigmatization because of the nevus. To proof a medical indication for surgical removal the~     investigators want to evaluate the quality of life and stigmatization before and after nevus~     surgery.~   "
98275|NCT02280876|"~     To evaluate the efficacy of ApE coated tablets, on the relapse rate in a group of relapsing~     remitting multiple sclerosis (RRMS) patients, as compared to a placebo group in a period of~     12 months. This study will also determine the safety and tolerability of the drug~     administered over interferon beta vs. administration of a placebo formulation (also over~     interferon) during the evaluation period. Response will be assessed and measured by daily~     self patient recording, monthly clinical neurologist, and every three months serological and~     magnetic resonance parameters.~      Place of Study: National study in Chile with one center at the Regional Hospital in the city~     of Valdivia, including 30 patients enrolled by their respective neurologists.~   "
98276|NCT02280863|"~     The primary objective of this pilot study is to evaluate the safety and efficacy of a hybrid~     closed loop (HCL) system in participants with type 1 diabetes. This HCL system utilizes the~     PID-IFB controller during the day and night in a closely monitored outpatient environment to~     allow assessment of the practical aspects of using the system for both the participant with~     diabetes and their parent or designated remote monitor.~   "
98277|NCT02280850|"~     Compared with placebo, assess of the efficacy and safety of Guanxin Shutong capsule to treat~     chronic stable angina (syndrome of blood stasis resistance), and the result will be used for~     the basis of later Ⅳ clinical trial.~   "
98278|NCT02280837|"~     In this study, the investigators hypothesized that significant proportion of patients with~     coronary artery disease (CAD) has reduced capacity of glucagon-like peptide-1 (GLP-1)~     secretion, which is detectable as blunted response of plasma active GLP-1 level to oral~     glucose loading and that reduced GLP-1 secretory function is associated with increased~     severity of coronary artery stenosis but not with classic risk factors for CAD. To test this~     hypothesis, the investigators will analyze correlation between GLP-1 secretory capacity and~     severity of coronary artery stenosis determined by Gensini Score (GS), an established score~     system for coronary artery stenoses. Additionally, the investigators will analyze~     relationship between level of total GLP-1 and severity of coronary artery stenosis to~     determine how it is different from the active GLP-1 - coronary stenosis relationship.~   "
98279|NCT02280824|"~     Background:~      - Some people who need a transcatheter aortic valve replacement (TAVR) have leg arteries that~     are too small and are too sick for standard techniques. But they may benefit from a new~     technique called transcaval TAVR. For this technique, doctors make a hole between the largest~     vein (vena cava) and largest artery (aorta) in the body, inside the abdomen. Then they~     replace the valve through a tube they put in the groin vein. Then they close the hole between~     the vein and the artery using a device designed to close holes in the heart. This study tests~     the device for this new, off-label use.~      Objective:~      - To further study the safety and effectiveness of transcaval TAVR.~      Eligibility:~      - Adults age 21 and older who would benefit from TAVR but for whom standard techniques are~     not suitable.~      Design:~        -  Participants will be selected by a team of heart specialists and others.~        -  Participants will have a computed tomography (CT) scan with or without contrast dye.~        -  Participants will have blood tests.~        -  Participants will have transcaval TAVR.~        -  Participants will receive the same standard care as for all patients with TAVR.~        -  Participants will also have another CT scan, or an MRI or ultrasound, before they leave~          the hospital, and again after about 30 days and after about 12 months.~        -  Participants will be contacted 1 and 6 months afterwards and will have another visit 1~          year later. They will have a CT, MRI, or ultrasound. They will have blood tests and a~          physical exam.~   "
98280|NCT02280811|"~     Background:~      The National Cancer Institute (NCI) Surgery Branch has developed an experimental therapy for~     treating patients with cancer that involves taking white blood cells from the patient,~     growing them in the laboratory in large numbers, genetically modifying these specific cells~     with a type of virus (retrovirus) to attack only the tumor cells, and then giving the cells~     back to the patient. This type of therapy is called gene transfer. Researchers want to test~     this on human papilloma virus (HPV)-associated cancers.~      Objective:~      - The purpose of this study is to determine a safe number of these cells to infuse and to see~     if these particular tumor-fighting cells (Anti-HPV E6) can shrink tumors associated with HPV~     and test the toxicity of this treatment.~      Eligibility:~      - Adults age 18-66 with an HPV-16-associated cancer.~      Design:~        -  Work up stage: Patients will be seen as an outpatient at the National Institutes of~          Health (NIH) clinical Center and undergo a history and physical examination, scans,~          x-rays, lab tests, and other tests as needed~        -  Leukapheresis: If the patients meet all of the requirements for the study they will~          undergo leukapheresis to obtain white blood cells to make the anti HPV E6 cells.~          {Leukapheresis is a common procedure, which removes only the white blood cells from the~          patient.}~        -  Treatment: Once their cells have grown, the patients will be admitted to the hospital~          for the conditioning chemotherapy, the anti HPV E6 cells and aldesleukin. They will stay~          in the hospital for about 4 weeks for the treatment.~      Follow up: Patients will return to the clinic for a physical exam, review of side effects,~     lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1~     year as long as their tumors are shrinking. Follow up visits take up to 2 days.~   "
98281|NCT02280798|"~     Do differences in endometrial gene expression exist after different protocols of endometrial~     preparation for embryo transfer? The recent apparition of endometrial receptive arrays~     technology let us know if endometrial is receptive or not in patients with some problems of~     infertility as implantation failure, for that we want to know if this technology would tell~     us if the different kind of protocols for endometrial preparation origin differences that~     could explain some of the founded results.~   "
98282|NCT02280785|"~     Brentuximab vedotin is an antibody-drug conjugate targeting CD30, one of surface antigens~     expressed in lymphoma cells. Fanale MA, et al. reported the results of a phase I study with~     weekly dosing of brentuximab vedotin in patients with relapsed/refractory CD30-positive~     hematologic malignancies (Clin Cancer Res. 2012) showed tumor regression in 85% of patients.~     Thus, the overall objective response rate was 59% (24/44) including 34% (n = 14) of complete~     remissions. This study mainly included Hodgkin lymphoma (n = 38) and anaplastic large cell~     lymphoma (n = 5). However, its efficacy in other types of NHL has never been reported~     although this study enrolled one patient with peripheral T-cell lymphoma not otherwise~     specified (PTCL-NOS).~      CD30 (TNFRSF8) is a transmembrane glycoprotein of the tumor necrosis factor receptor (TNFR)~     superfamily, and it is involved in signal transduction via the activation of the NF-κB~     pathway and the mitogen-activated protein kinases (MAPKs), ultimately modulating cell growth,~     proliferation and apoptosis. CD30 is a non-lineage-specific activation marker expressed by~     scattered B and T immunoblasts. In addition, a subset of cases in virtually all T-cell~     lymphoma entities may also express CD30 but at variable and generally lower levels. In fact,~     a recent study in 22 patients with extranodal NK/T-cell lymphoma showed 75% of positive rate~     of CD30 expression (75%). Moreover, CD30 expression was also documented in the tumor sample~     of EB virus positive diffuse large B-cell lymphomas (EBV + DLBCL) of the elderly (28.9%,~     11/38). Therefore, Brentuximab vedotin may have potential benefits for patients with~     CD30-positive NHL other than anaplastic large cell lymphoma such as CD30-positive PTCLs, NOS.~     Considering the role of CD30 in signal transduction pathway associated with tumor growth and~     proliferation, its expression may be associated with tumor aggressiveness. In accordance with~     this, it is more likely that relapse or refractory NHLs may have CD30 expression, and the~     potential benefits of this promising agent as a salvage therapy deserve to be further~     investigated in these patients who have high risk of treatment failure. Thus, we designed a~     phase II study for relapsed or refractory NHL patients. This study is to explore the safety~     and activity of dosing once every 3 weeks of Brentuximab vedotin in patients with relapsed or~     refractory CD30-positive NHL other than anaplastic large cell lymphoma.~   "
98283|NCT02280772|"~     Glucomannan (GNN), a water-soluble dietary fiber derived from the plant Amorphophallus~     konjac, is marketed for weight reduction. The exact mechanisms by which GNN might exert its~     actions are unclear. Nonetheless, it has been shown that GNN slows gastric emptying by~     forming a viscous gel of large volume, which increases the feeling of satiety. Current~     evidence on the effectiveness of GNN for weight reduction is sparse, and well-designed trials~     performed in children are needed to assess the efficacy of this modality. We aim to~     systematically evaluate the efficacy of GNN consumption for the management of overweight and~     obesity in children.~   "
98284|NCT02280759|"~     Gelatin tannate possesses astringent, antibacterial, and anti-inflammatory properties. It is~     increasingly being marketed as an antidiarrheal drug. A randomized, double blind,~     placebo-control trial was performed to assess the effectiveness of GT in management of~     children with acute gastroenteritis.~   "
98285|NCT02280746|"~     BACKGRUOUND: Autism spectrum disorder (ASD) is a common condition. The etiology of ASD~     remains unknown. Recent studies suggest a link between elimination diets and severity of~     autistic symptoms. The possible effects of a gluten-free diet (GFD) on symptoms remain~     unknown.~      AIM: The aim of the study is to evaluate the impact of gluten challenge on the autistic~     symptoms in children with autism spectrum disorders (ASD) and on a gluten-free diet (GFD) in~     comparison to individuals continuing GFD.~      METHODS: 70 children with ASD aged 3-5 and 11/12 remaining on GFD for at least 8 weeks will~     be randomly assigned to gluten-free and gluten-challenge diet.~   "
98286|NCT02280733|"~     More than 100 hospital based outpatient wound centers in the USA and Puerto Rico agree to~     transmit structured data on all patients followed with chronic wounds and ulcers (e.g.~     diabetic foot ulcers, venous ulcers, pressure ulcers, arterial ulcers, surgical wounds, and~     traumatic wounds). Data are collected at point of care including adherence to wound care~     quality measures developed by the USWR as a Qualified Clinical Data Registry (QCDR).~   "
98287|NCT02280720|"~     The purpose of this study is to compare vascular healing of the stented segment after~     deployment of titanium-nitride-oxide coated cobalt-chromium Optimax™-stent stent and~     Promus-Element™ everolimus-eluting stent in patients with acute coronary syndromes requiring~     percutaneous coronary intervention.~        1. Comparison of OCT and CFR findings of titanium-nitride-oxide coated cobalt-chromium~          Optimax™-stent and Promus-Element™ everolimus-eluting stent at two months after the~          index procedure.~        2. Comparison of intravascular coronary flow reserve measurement to non-invasive~          transthoracic echocardiography-derived coronary flow reserve measurement.~        3. Comparison of epicardial vasodilation to coronary microcirculatory vasodilation~   "
98288|NCT02280707|"~     This study, randomized, delivered, and analyzed at the school level, evaluated the effect of~     simple, structural changes to school lunch rooms to make drinking water easier for students~     during lunch time. Half of the schools received posters promoting drinking water and~     installed cup dispensers stocked with cups next to lunchroom water fountains, while the other~     half received no intervention. The intervention outcomes were average water consumption and~     the proportion of students in the lunchroom who opted to drink water, as well as the~     proportion of students with sugary drinks at lunch. No identifying information on individual~     children was collected.~   "
98289|NCT02280694|"~     This study investigates the activity of a new regimen of treatment for patients with~     metastatic colorectal carcinoma. This includes a combination of well-known chemotherapy~     agents and anti-inflammatory agents, when administered orally at low daily doses and without~     planed brakes (Low Dose Metronomic regimen), in contrast with the conventional and already~     exhausted regimens of treatment at Maximal Tolerated Doses (MTD) which required pre-planned~     brakes between treatment days.~   "
98290|NCT02280681|"~     To gain insight by means of a discrete choice experiment questionnaire into characteristics~     of medically assisted reproduction (MAR) with artificial gametes (AGs) valued by couples~     confronted with ovarian failure and their physicians and the trade-offs they make between~     these treatment characteristics.~   "
98291|NCT02280668|"~     The purpose of our research is to investigate the effects of applying cold therapy, or~     icing, to injured muscles in terms of strength recovery and muscle soreness amelioration~     following unaccustomed exercise.~   "
98339|NCT02280031|"~     Low-dose aspirin started in the first-trimester has been associated with a decrease of~     preeclampsia, fetal growth restriction and preterm birth in high-risk pregnancies. Multiple~     pregnancies are considered a risk factor for all those adverse outcomes. The main objective~     of the current trial is to evaluate whether a dose of 80 mg of aspirin is associated with an~     improvement of birthweight compared to placebo in twin pregnancies.~   "
98340|NCT02280018|"~     The purpose of this study is to assess the safety, tolerability, and pharmacokinetics (the~     study of the way a drug enters and leaves the blood and tissues over time) of JNJ-49122944 in~     healthy male participants after a single intravenous ([IV] within a vein) dose~     administration.~   "
98292|NCT02280655|"~     Transfusion of red blood cells is often used in critically ill patients with low red blood~     cell counts to prevent disease progression and death. Recent studies suggest that the use of~     aged versus fresh red blood cells are associated with worse clinical outcomes. There is~     evidence that red blood cells work with the cells lining our blood vessels to produce a~     variety of substances that normally cause arteries to relax and increase blood supply. Two of~     these substances are called nitric oxide (NO) and endothelium-derived hyperpolarizing factor~     (EDHF). The investigators are trying to determine the nature of these substances in human~     beings when they are transfused aged versus fresh red blood cells. The purpose of the~     study is to test the effects of transfusing aged versus fresh red blood cells in~     volunteers with traditional cardiovascular risk factors (high blood pressure, diabetes, high~     cholesterol, and tobacco use) on 1) the degree of relaxation in the arteries and subsequent~     changes in blood flow, 2) blood levels of oxidant molecules, 3) inflammation, and 4) stem~     cells.~      A similar study with healthy volunteers are further described in NCT00838331.~   "
98293|NCT02280642|"~     The purpose of this study was to determine if delayed dosing of recombinant human~     papillomavirus (HPV) quadrivalent (Types 6, 11, 16, and 18) vaccine in 9-18 year old girls~     elicited an equivalent immune response (geometric mean titers to HPV 6,11,16, and 18 as~     measured one month after receipt of a 3rd dose of HPV vaccine) when compared to vaccine~     delivered according to the recommended dosing schedule.~      This was a prospective observational study of healthy 9-18 year old female patients receiving~     either a second or third dose of HPV vaccine as part of their well child care. Immune~     responses to HPV types 6, 11, 16 and 18 were measured both before and 1 month after the third~     dose of HPV vaccine with the purpose of comparing the immune responses to HPV vaccine when~     administered at naturally occurring longer dosing intervals to the immune response to HPV~     vaccine when administered as routinely recommended.~      In addition, girls receiving a 3rd dose of HPV vaccine as well as concomitantly administered~     vaccines by injection were randomized to receive either the HPV vaccine first or their~     concomitantly administered vaccines first. Pain following vaccination was assessed in each~     arm using the Faces Pain Scale - Revised.~      Please note: This record refers only to the observational portion of the study. Please refer~     to NCT00862810 for the results of the randomized portion of the study.~   "
98294|NCT02280629|"~     The purpose of this study is to prove the superiority of a 48-weeks treatment with 3.2 g/day~     delayed-release phosphatidylcholine (LT-02) versus placebo for the maintenance of remission~     in patients with ulcerative colitis (UC)~   "
98295|NCT02280616|"~     The purpose of this study is to assess the efficacy of a low and high dose of a budesonide~     effervescent tablet and oral viscous budesonide suspension vs. placebo for the induction~     treatment of active eosinophilic esophagitis.~   "
98296|NCT02280603|"~     This study is designed to explore the efficacy and safety of DA-4001 after topical~     application in male patients with androgenetic alopecia~      Design : Randomized, double-blind, active-controlled study~      Investigational Product : Finasteride, minoxidil~   "
98297|NCT02280590|"~     Comparison of the efficacy and safety of Cresnon® and Crestor® in patients with~     hyperlipidemia~      - 8-week, active-controlled, open-label, randomized, parallelgroup, fixed-dose,~     noninferiority, multicenter, phase 4 design~   "
98298|NCT02280564|"~     FL3X is an integrated diabetes self-management system that incorporates modern cell phone~     technology with behavioral modification approaches to improve diabetes self-management in~     high-risk youth. Utilizing such approaches will increase adherence to diabetes management~     behaviors and improve glucose control by providing increased autonomy over diabetes care.~   "
98299|NCT02280551|"~     Parents can positively influence their children's alcohol use. One strategy they use is to~     provide their children with alcohol, believing it is the best way to teach their children how~     to drink responsibly. The impact of parental supply is not well understood and may be~     unintentionally harmful. This study will research the consequences of parental supply within~     the broader context of parent, child and peer relationships. It will help to determine how~     parental supply influences the different patterns of adolescent alcohol consumption over~     time, providing essential information to help parents prevent alcohol misuse in their~     children. Parents can play a pivotal role in prevention of alcohol misuse, but at present we~     don't know exactly how.~   "
98300|NCT02280538|"~     The present study is designed to test the hypothesis that Intra-Articular Hyaluronic Acid~     (IAHA) is superior to placebo in slowing structural progression and on long term symptomatic~     effect in primary knee Osteoarthritis (OA) patients.~      The investigators will perform a multicenter double-blind, randomized, placebo-controlled,~     parallel group trial.~   "
98301|NCT02280525|"~     The goal of this clinical research study is to find the highest tolerable dose of immune~     cells called natural killer (NK) cells that can be given with chemotherapy to patients with~     CLL. Researchers want to learn if adding NK cells will be effective in treating the disease.~     The safety of this will also be studied.~      NK cells may kill cancer cells that remain in your body after your last chemotherapy~     treatment. The NK cells will be separated from umbilical cord blood. The device used in the~     laboratory to separate the NK cells is called a CliniMACS. These separated NK cells will then~     be grown in the lab to increase the number of NK cells that can be given to you by vein.~      This is an investigational study. Rituximab, fludarabine, and cyclophosphamide are FDA~     approved and commercially available for the treatment of CLL. Cytarabine, filgrastim, and~     lenalidomide are FDA approved and commercially available for the treatment of other types of~     cancer. The use of cytarabine, filgrastim, and lenalidomide for the treatment of CLL is~     investigational.~      The use of NK cells is investigational. The NK cell process is not FDA approved or~     commercially available. It is currently being used for research purposes only.~      Up to 44 patients will take part in this study. All will be enrolled at MD Anderson.~   "
98341|NCT02280005|"~     This is a prospective, interventional study designed to provide preliminary data on the human~     use of the WAK. Up to 10 subjects currently receiving intermittent hemodialysis (HD)~     treatment three times per week for end-stage renal disease (ESRD) via an indwelling tunneled~     catheter will be studied.~   "
98417|NCT02279017|"~     To assess the feasibility to translate an automated weight loss message intervention to a~     weight loss clinic population.~      Aim 1: To assess feasibility of translating the intervention in a clinic for patients who~     recently completed a structured weight loss program.~      Aim 2: To assess the ability to capture a trajectory of self-reported weight over 6 months~     through an automated intervention.~   "
98302|NCT02280512|"~     In Taiwan, about 75.92% of the elderlies above 65 years old suffered from chronic diseases or~     major diseases, especially in circulatory system. Thus, dramatic hemodynamic change is often~     observed in surgeries in this population. Due to osteoporosis and high-prevalence~     morbidities, trauma with fracture is quite common. These elderlies are more vulnerable to~     have complications, poor prognosis and decompensated organ functions.~      The investigators would like to observe the perfusion of different tissue intra-operatively,~     and to find the correlation with surgical outcome. There are many non-invasive hemodynamic~     monitors nowadays. In our study, the investigators will use noninvasive cardiac output~     measurement(NICOM), and non-invasive transcutaneous near infrared spectroscopy(NIRS) to~     observe hemodynamic change and tissue perfusion. After the surgery, the duration in ICU will~     be recorded. A questionnaire, SF-36, will be mailed to the patients 2 months after the~     surgery to measure the psychometric status.~   "
98303|NCT02280499|"~     Overall study design:~      This study is a prospective, multicenter, postmarket clinical observation to validate the~     PROMOS™ Standard Shoulder System as state-of-the-art implant system for total shoulder~     arthroplasty in terms of radiographic and clinical performance as well as long-term~     survivorship over 10 years.~   "
98304|NCT02280486|"~     This is a multi-centre, open-label, randomized, parallel trial to investigate the efficacy~     and safety profile of saxagliptin and glimepiride treatment in patients with type 2 diabetes~     inadequately controlled with metformin monotherapy.~   "
98305|NCT02280473|"~     This study will evaluate the safety and efficacy o fRefresh Optive® Gel Drops in patients~     with dry eye disease.~   "
98306|NCT02280460|"~     To create a local registry for ECMO patients.~   "
98307|NCT02280447|"~     The background of the clinical trial is the overall aim of the World Health Organization~     (WHO) to obtain eradication of polio in the world. As part of this overall plan, inactivated~     polio vaccine (IPV) against poliovirus types 1, 2 and 3, at an affordable price, needs to~     become available in low resource third World countries.~      The primary objective of the phase I/II clinical trial is to provide proof of concept (POC)~     that up to 10 times dose reduction of IPV SSI does not decrease the immunogenicity clinically~     significantly compared to full dose IPV SSI, by demonstrating the non-inferiority of the~     booster effects of each of 3 Al(OH)3 adjuvated reduced dose IPV formulations (1/3 IPV-Al SSI,~     1/5 IPV-Al SSI and 1/10 IPV-Al SSI) compared to non-adjuvated full dose IPV SSI.~      A total of 240 healthy adolescents with a history of IPV SSI vaccination at 3, 5, 12 months~     and 5 years of age according to the Danish vaccination program will be included in the trial.~   "
98308|NCT02280434|"~     This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of~     CBP-307 following oral single and multiple escalating dose administration in healthy~     subjects.~   "
98309|NCT02280421|"~     ASP2151 is an experimental treatment for herpes. Patients undergoing organ and tissue~     transplantation may be prescribed ciclosporin to suppress their immune system to give the~     transplant an increased chance of not being rejected. A patient with a compromised immune~     system is more susceptible to infections such as herpes, which will require treatment.~   "
98310|NCT02280408|"~     Ebola virus has infected and killed people, mostly in Africa. In 2014, the Ebola virus has~     affected several thousand people. There is no approved effective way to treat or prevent~     Ebola. Researchers are trying to develop a vaccine for it. This is a study of the anti-Ebola~     vaccine VSV ZEBOV (BPSC-1001) to see if it is safe and to see how it affects people's immune~     system.~   "
98311|NCT02280395|"~     This is a double-blind, randomized, parallel-group, controlled, multi-center study to~     evaluate the safety and efficacy of RUT058-60 (Group A) as an intra-cavity lavage compared to~     sterile saline (Group B) in adult subjects undergoing abdominal surgery.~   "
98312|NCT02280382|"~     The main purpose of the feasibility study is to identify the patient experience of Femmeze®~     which is a device aimed at improving posterior vaginal compartment prolapse (rectocele) for~     women with obstructive defaecation. The investigators want to investigate implementation and~     preliminary effectiveness of the device. The method of investigation will be a pre-post~     intervention design, which involves asking 30 women to use Femmeze® over a period of 8 weeks.~     This is an academic study on a labelled indication~     (http://www.nres.nhs.uk/search/?q=medical+devices).~   "
98313|NCT02280369|"~     The automated inflatable abdominal binder is an investigational device for the treatment of~     orthostatic hypotension (low blood pressure on standing) in autonomic failure patients. The~     purpose of this study is to evaluate the performance of the binder in detecting body posture~     during different types of human motion patterns and activities of daily living, and to~     develop new (and better) ways to detect upright posture. In particular, the investigators~     want to determine if activities of daily living, normally encountered by patients (lying~     down, sitting, standing, walking, and climbing up and down steps), interfere with the~     detection of upright posture used to trigger the device. Studies will be conducted in healthy~     subjects because the main purpose of this study is to evaluate posture detection rather than~     treating orthostatic hypotension.~   "
98314|NCT02280356|"~     The purpose of this study is to test the safety and side effects of ultra-hypofractionated~     radiation therapy when used after brachytherapy (radiation implants). This treatment delivers~     a higher radiation dose with each treatment over a shorter period of time.~   "
98315|NCT02280343|"~     Inhalation of dust containing asbestos results in a process of interstitial pulmonary~     fibrosis called asbestosis. The Forced Oscillation Technique (FOT) evaluates the respiratory~     mechanics describing resistive, elastic and inertial properties. We believe that this~     technique may contribute to the early diagnosis of asbestosis.~   "
98316|NCT02280330|"~     Iodine deficiency remains widespread worldwide with children as among the vulnerable groups~     considering their stage of growth and development. In the Philippines, current data shows an~     optimal status among schoolchildren, however no data exists on iodine status nor intake of~     preschool children. One recent approach to improvement of the vitamin and mineral status of~     the population is home fortification using micronutrient powder or MNP. This contains 15~     vitamins and minerals, including iodine and iron. Current guidelines exist for MNP use to~     improve iron status and reduce anemia among infants and young children 6-23 months old, but~     did not mention use among preschoolers such as those in day care centers. This study,~     therefore, aims to compare the iodine status and growth of day care children given MNP for 6~     months.~   "
98317|NCT02280317|"~     Dose finding safety study of VAL201 in cancer patients.~   "
98318|NCT02280304|"~     The goal of this study is to learn more about how Inner Resources for Veterans (IRV)~     meditation therapy helps Veterans with Post Traumatic Stress Disorder (PTSD) and mild~     traumatic brain injury (mTBI). PTSD is a disorder that occurs after exposure to one or more~     traumatic experiences. People with PTSD may experience anxiety, pay extra attention to their~     surroundings, involuntarily remember their traumatic experiences, and/or want to avoid~     situations where these symptoms are increased. MTBI may result from being in a blast~     explosion, with pressure from the blast potentially disrupting the brain's structure and~     function. At this time, it is not well known how PTSD and mTBI may affect each other.~      In this study, the investigators will be looking at the behavioral and neurological changes~     (changes in the brain) and the reductions in PTSD symptoms that may come from participating~     in this treatment. The investigators are interested in determining if treatment does reverse~     changes in the brain caused by PTSD and mTBI. To help the investigators understand changes in~     how the brain functions, the participants will complete a functional magnetic resonance~     imaging (fMRI) scan before and after either a 8-week course of IRV or 8 weeks of education~     about PTSD and mTBI. Participation will help the investigators understand how therapy for~     PTSD and mTBI impacts the brain's response to emotions and therapeutic processes.~   "
98319|NCT02280291|"~     Peripheral nerve blocks have been well studied in the literature with generally good results~     for controlling post operative pain following orthopaedic surgery. Regional anesthesia has~     many benefits. It provides excellent intraoperative anesthesia and muscle relaxation as well~     as analgesia that continues into the post-operative period. These regional blocks are also~     effective in controlling pain in the immediate post-operative period. However, as the block~     wears off, patients begin experiencing increased pain. Compared to patients treated without~     regional blocks, these patients will often experience a rebound pain--pain occurring 12-24~     hours after surgery that is subjectively worse than that in patients treated without regional~     blocks. Therefore, the investigators propose to use a continuous infusion of anesthetic in~     order to provide sustained pain control post-operatively. Preoperatively, patients will be~     randomized into a single shot peripheral nerve block versus a continuous infusion of~     peripheral nerve block. Post-operatively, pain will be assessed using the Visual Analogue~     Scale (1-100) prior to being discharged from PACU. Time to discharge and amount of pain~     medication taken will be recorded. Patients will be contacted at certain time intervals~     postoperatively to assess their pain scale and pain medication intake. Patients will be seen~     for routine post-operative follow-up visits where they will be assessed for satisfaction,~     pain, residual neurological symptoms, and signs of infection.~   "
98320|NCT02280278|"~     We hypothesize through this randomized, prospective, single center adjuvant study, that~     cytokine-induced killer cell in patients with stage III colon cancer can improve survival in~     this patient population over control. Stage III colon cancer patients can benefit most from~     adjuvant chemotherapy, but the 5 year survival rate is still around 60%. We wish CIK cell~     therapy can improve the survival rate of stage III colon cancer patients.~   "
98321|NCT02280265|"~     Hemophilia A is an X-linked recessive, congenital bleeding disorder caused by deficient or~     defective coagulation factor VIII (FVIII). Prophylaxis is recommended as the standard of care~     for boys with severe haemophilia by WHO and World Federation Of Hemophilia (WFH). The~     efficacy and safety of prophylaxis in preventing bleeds and arthropathy in patients with~     hemophilia has been confirmed in well-designed clinical studies.To keep the factor level~     above 1%, the standard dosage for patients with severe hemophilia A is 20-40 Units~     /kg/infusion (average 30 Units /kg) every other day or three times a week. This dosage has a~     very high consumption of factor, up to 5000-6000 international unit (IU)/kg/year. The high~     consumption of factor and cost present a major barrier to use the standard prophylaxis in~     many countries particularly in the developing world.~      In China the majority of boys with severe hemophilia A can only pay for on-demand treatment~     or low-dose prophylaxis. Ao after the affordability of patients was solved and many patients~     will get more chance to receive standard prophylaxis.~      This study is designed to evaluate the Annual Bleeding rate (ABR), joint health outcomes and~     QoL outcomes in subjects using ADVATE(Recombinant Human Coagulation Factor VIII for~     injection) standard prophylaxis under the conditions of routine practice.~   "
98322|NCT02280252|"~     The need to understand LABC is especially compelling in populations and countries with~     limited resources, where breast cancer incidence is relatively low, but mortality is~     comparably high. In these settings access to appropriate cancer care is characteristically~     limited or often plainly nonexistent. In contrast to economically developed nations, where on~     average fewer than 20% of women present with breast cancer at advanced stages, LABC and~     metastatic disease are the most common stages at presentation in 50% or more women in Latin~     America, Asia and Africa.~   "
98323|NCT02280239|"~     The intensive care unit (ICU) team needs to know what effects acetaminophen has in critically~     ill patients. Acetaminophen is better known as Tylenol. It is the drug given to reduce fever.~     Most research that has looked at how safe and effective this drug is, has been done with~     healthy people. Those studies tell us it is safe and works well to bring down fever.~      This may not be true for the ICU patient. Some research found acetaminophen was not as good~     at reducing fever as expected in the ICU. Fever helps to fight infection so it may help~     patients get better, but it is also stressful. When you have fever, you to need more oxygen,~     and your heart beats faster. If you have a fever after brain injury, you are less likely to~     make a full recovery. In patients with brain injury, a weak heart or trouble breathing we~     should treat fever. If we can predict how well acetaminophen will reduce fever, we can decide~     if this drug is enough, or other treatments are also needed.~      If you do not have problems with your brain, heart, or lungs, it is safe to not treat fever.~     When you give this drug to treat fever, the body cools itself by sweating, and bringing hot~     blood to the skin's surface. These changes do not affect healthy people. Research suggests~     ICU patients may be at risk for sudden drop in blood pressure.~      Our study will answer 2 questions: 1) When acetaminophen is given to treat fever in ICU~     patients, are they more likely to have a drop in blood pressure? 2) How much will~     acetaminophen reduce fever in ICU patients? We will study ICU patients with a fever who can~     safely get, or not get this drug. This information will help us decide when and how to treat~     fever in the ICU.~   "
98354|NCT02279836|"~     The objective of the study is to gather post-market data regarding the performance of the~     invendo SC20 colonoscope in a real-world US population.~   "
98328|NCT02280174|"~     Overproduction of intestinally derived triglyceride-rich lipoproteins (TRLs) (chylomicrons)~     has recently been described in type 2 diabetes (T2DM), as is known for hepaticTRL~     (very-low-density lipoprotein) production.~      There is an interest in identifying therapies that would favourably influence postprandial~     concentrations of lipids in T2DM.~      linagliptin is a potent and selective inhibitor of dipeptidyl peptidase IV (DPP-IV), and has~     been shown to reduce fasting and postprandial glucose levels in patients with type 2 diabetes~     mainly through incretin hormone-mediated improvements in islet function.~      Although clinical studies to date indicate that fasting lipid levels are minimally affected~     by DPP-IV inhibitor treatment, animal studies suggested that DPP-IV inhibition reduce~     intestinal triglycerides (TG) absorption and apolipoprotein (apo) production and increased~     chylomicron catabolism. Interestingly, a recent study supporting this hypothesis showed that~     vildagliptin therapy was able to reduce postprandial intestinal TRL particles in patients~     with type 2 diabetes. Recently, it had reported that sitagliptin treatment significantly~     reduced plasma apoB-48 and TG concentrations in the postprandial state.~      The action of DPP-IV inhibitors may be explained by insulin secretion or action of~     glucagon-like peptide (GLP-1) on metabolism of TRL.~      Therefore, the present study was designed to examine the effects of linagliptin treatment~     (LT) vs standard treatment (ST) on the metabolism of TRL apoB-48 in patients with type 2~     diabetes over a 12 weeks-period.~      The investigators will study the patients in three different moments defined as: Time 0 (2~     weeks before LT or ST, Time 1 (4 weeks after LT or ST), Time 2 (12 weeks after LT or ST).~     With areas under the curve (AUCs) of apoB48 in postprandial conditions.~   "
98329|NCT02280161|"~     This research trial studies germ-line mutations in blood and saliva samples from patients~     with cancer. Studying samples of blood and saliva from patients with cancer in the laboratory~     may help doctors learn more about how inherited genetic mutations can affect cancer~     predisposition (an inherited increase in the risk of developing cancer), their impact on~     treatment response, and their role in cancer development.~   "
98330|NCT02280148|"~     The purpose of this study is to assess the driving and cognitive ability of gastrointestinal~     endoscopy patients at different time points after intravenous anesthesia (propofol for~     example), and to explore whether the driving and cognitive ability have a relationship with~     the blood concentration of propofol or not.~   "
98331|NCT02280135|"~     The purpose of this study is to evaluate the safety of intravitreal injection of autologous~     bone marrow stem cells in patients with retinitis pigmentosa by a prospective, single-center,~     randomized, parallel, double-blind, phase I placebo-controlled clinical trial.~   "
98332|NCT02280122|"~     Background: Untreated periodontal disease may influence general health. However, how may a~     physician who is not trained in periodontal probing detect untreated periodontitis? Activated~     matrix metalloproteinase-8 (aMMP-8) in saliva correlates with periodontal probing parameters.~     Thus, sensitivity and specificity of a chair-side test for activated matrix~     metalloproteinase-8 to detect periodontitis was evaluated.~      Methods: Thirty cases (untreated chronic periodontitis; 15 generalized moderate and 15~     generalized severe) and 30 controls (probing pocket depths ≤ 3 mm, vertical probing~     attachment level ≤ 2 mm at < 30% of sites) were examined periodontally. Further, the~     activated matrix metalloproteinase-8 test was performed. The test kit becomes positive with ≥~     25 ng/ml activated matrix metalloproteinase-8 in the sample.~   "
98333|NCT02280109|"~     This is an open label comparative study of tenofovir gel and film in 10 healthy sexually~     active women without active female genital tract disorders. The women will receive a single~     dose of each formulation - tenofovir gel (1%;equivalent to 40 mg in 4ml's of gel) and~     tenofovir film (1.3%;40 mg) - in a crossover study design to determine the pharmacokinetics~     of tenofovir in the blood, cervical tissue, and cervicovaginal fluid (primary objective).~   "
98334|NCT02280096|"~     Twenty four RRMS patients over the age of 18, with similar degree of disability, and with an~     evolution of at last 6 months, who are in first-line immunomodulatory therapy and have a~     stable disease (no more than one outbreak per year) will be included in the present study.~     Patients will be administered a neuropsychological test battery selected for this study and~     divided into two sessions of one and a half-hour each. Emotional state will be assessed with~     the Beck Depression Inventory in a different session. Cognitive impairment is defined as the~     alteration of two or more neuropsychological tests. Patients will be divided randomly into~     two groups where one will receive placebo and the other one 4-AP for a period of four months~     in increasing doses.~   "
98335|NCT02280083|"~     This is a multicenter, double-blind, randomized, placebo-controlled study designed to compare~     Botulinum Toxin Type A for Injection (HengLi®) with placebo on the efficacy and safety of~     treatment in post-stroke subjects with focal wrist, finger and in some cases, thumb~     spasticity. Approximately 180 subjects will be enrolled. The core period of the subjects will~     receive a single treatment session of intramuscular HengLi® 200U or 240U (if thumb spasticity~     is present) or placebo in a randomization ratio of 2:1. Research contains two parts: core~     phase and extension phase. In the core phase, subjects will finish 6 visits (12 weeks ) after~     initial injection. During the extension phase, subjects will accept two follow-up visit (6~     weeks). Outcome measures include changes from baseline at every post injection visit as~     measured on the Modified Ashworth Scale (MAS), Disability Assessment Scale (DAS) and Global~     Assessment Scale(GAS). The primary efficacy endpoint is the change from baseline at week 6~     for wrist flexor muscle tone as measured on the Modified Ashworth Scale. Safety parameters~     will also be measured including adverse events, vital signs (pulse and blood pressure) and~     clinical laboratory tests (haematology, serum chemistry and urinanalysis).~   "
98336|NCT02280070|"~     To evaluate the efficacy and safety of SOX or mFOLFOX6 as neoadjuvant chemotherapy in~     patients with resectable rectal cancer, and to identify the more promising regimen.~   "
98337|NCT02280057|"~     The investigators wanted to elucidate the effects of metformin in Polycystic Ovary Syndrome~     (PCOS) by performing a randomized, double-blinded, placebo-controlled cross-over study.~   "
98338|NCT02280044|"~     This study is a randomized, double-blinded, placebo-controlled, in-patient trial evaluating~     the prophylactic efficacy of rifaximin against campylobacteriosis following challenge with C.~     jejuni.~   "
98355|NCT02279823|"~     In this proof-of-concept study, the safety and efficacy of a solution formulation will be~     investigated in male subjects with androgenetic alopecia (AGA) after twice daily application~     for up to 26 weeks.~   "
98342|NCT02279992|"~     This is a randomized pilot study to investigate the ability of a phosphodiesterase-V~     inhibitor (vardenafil) to increase the concentration of systemically delivered chemotherapy,~     carboplatin, in patients with recurrent malignant gliomas or metastatic brain cancer. This~     study will also determine the toxicity and tolerability of a phosphodiesterase-V inhibitor~     (vardenafil) in combination with intravenous carboplatin for patients with recurrent~     malignant gliomas or metastatic brain cancer.~   "
98343|NCT02279979|"~     The primary objective of this study is to assess reasonable safety and performance of the~     HeartMate PHP to provide hemodynamic support for up to 72 hours in patients with cardiogenic~     shock requiring stabilization.~   "
98344|NCT02279966|"~     To assess the efficacy of acute treatment with 10 mg/day vortioxetine versus placebo on~     cognitive performance (focusing on the aspect concerning speed of processing, executive~     functioning, attention) in working patients with major depressive disorder (MDD).~   "
98345|NCT02279953|"~     To assess the efficacy of vortioxetine (10 to 20 mg/day) as adjunctive treatment to stable~     selective serotonin reuptake inhibitor (SSRI) dose versus stable SSRI monotherapy on~     cognitive performance (focusing on the aspect concerning speed of processing, executive~     functioning and attention) in patients who are in partial or full remission from their Major~     Depressive Episode (MDE).~   "
98346|NCT02279940|"~     Atrial fibrillation is a common cardiac arrhythmia and a major risk for ischemic stroke.~     Furthermore the risk of stroke is higher in the first month after transient ischemic attack~     (TIA)/stroke. Rivaroxaban has been approved by Health Canada over period of last two years~     for prevention of stroke and have been found equally effective as oral Vitamin K antagonist.~     The foremost benefits of NOAC are reduced intracranial bleeding risk and does not require~     coagulation monitoring.~      Optimal timing of anticoagulation after TIA/stroke in patients with known non-valvular atrial~     fibrillation is not known. The practice is variable and opinion based. The bias for many~     stroke physicians and neurologists is to start later (after 1-2weeks) to prevent hemorrhagic~     transformation thus possibly exposing the patients to an increased risk of recurrence. The~     product monograph for the drug suggest to wait for variable of 3 to 14 days before starting~     the NOAC (Waiting period:14 days for dabigatran and rivaroxaban, 7 days for Apixaban after~     ischemic stroke and three days after TIA for rivaroxaban). The times have been chosen~     arbitrary.~      The investigators aim to study incidence of symptomatic hemorrhage in patients with~     non-valvular atrial fibrillation who are initiated with new oral anticoagulants early after~     TIA and stroke.~   "
98347|NCT02279927|"~     A prospective study comparing different laser settings used for stone fragmentation during~     ureteroscopy~   "
98348|NCT02279914|"~     This study is a blinded randomized trial to compare two different doses and intervals of~     buccal misoprostol for cervical preparation before surgical abortion at 13 to 16 weeks'~     gestation: 400 mcg administered 3 hours before D&E (dilation and extraction), and 600 mcg~     administered 1.5 hours before D&E.~      Primary objective: To compare operative times after two different doses and intervals of~     misoprostol using a non-inferiority design.~      Secondary objectives: To compare the doses and intervals of misoprostol for differences in:~     (1) initial cervical dilation; (2) need for mechanical dilation and ease of dilation if~     required; (3) ability to complete the abortion procedure without further cervical~     preparation; (4) complications; (5) provider variables including ease of procedure and~     satisfaction with cervical preparation; (6) patient variables including pre-operative side~     effects, post-operative pain, and acceptability~   "
98349|NCT02279901|"~     The primary and well-known challenge with continuous positive airway pressure (CPAP) is the~     incomplete adherence of patients to this therapy. Successfully improving CPAP use is likely~     through emphasizing patient education regarding the risks associated with obstructive sleep~     apnea (OSA), potential benefits of therapy, teaching techniques to acclimate to CPAP, and~     providing a system of accountability through a follow-up process. With the changing landscape~     of healthcare reimbursement which emphasizes achieving positive clinical outcomes,~     discovering more automated and self-directed methods of educating and follow-up is needed.~      The investigators plan to investigate the impact of adjunct Web education and automated~     follow-up on CPAP use and other measurements of patient engagement. The specific aims of this~     pilot study are as follows:~        1. Assess impact of Telemedicine mechanisms on CPAP use 3 months after initiating therapy~          in comparison to usual standard of care.~        2. Assess impact of Telemedicine mechanisms on functional outcomes and parameters of~          healthcare utilization at 3 months after initiation of therapy in comparison to usual~          standard of care.~   "
98350|NCT02279888|"~     The purpose of the CardioMEMS HF System Post Approval Study (PAS) is to evaluate the use of~     the CardioMEMS HF System in patients with NYHA class III heart failure in a commercial~     setting.~   "
98351|NCT02279875|"~     The purpose of this study is to evaluate the mycobactericidal activity, safety, tolerability,~     and pharmacokinetics of 6 doses of linezolid: 300 mg once per day, 300 mg twice per day, 600~     mg once per day, 600 mg twice per day and 1200 mg once per day administered orally for 14~     consecutive days or 1200 mg administered three times per week for two weeks in adult subjects~     with newly diagnosed drug‐sensitive, smear‐positive pulmonary tuberculosis.~   "
98352|NCT02279862|"~     The purpose of this study is to examine the safety and effectiveness (how well the drug~     works) of two different doses (3 mg/kg and 10 mg/kg) of Ipilimumab (Yervoy™) in patients with~     metastatic castration resistant prostate cancer.~   "
98353|NCT02279849|"~     The overarching goal of B'More Healthy Retail Rewards (BHRR) is to develop, implement, and~     evaluate a pilot multi-level communications and pricing intervention to improve access to and~     consumption of healthy foods in low-income areas of Baltimore City, Maryland. BHRR has three~     primary aims: (1) to conduct formative research with representatives of multiple levels of~     the Baltimore food environment (i.e., local wholesalers, retail food store owners, and~     consumers) in order to select key foods for promotion, and determine appropriate~     communications and healthy food price reduction strategies, (2) to pilot the multi-level~     program with 2 local wholesale stores, and 24 small corner stores and their customers, and~     assess program implementation through detailed process evaluation, and (3) to assess impact~     of multilevel health communications and pricing strategies, combined and separately, on~     consumer dietary patterns and food source use, food purchasing behaviors, psychosocial~     variables, food security, and individual weight and height.~   "
98359|NCT02279771|"~     Anastomotic leak after low rectal cancer surgery occurs between 3 and 24% of the cases and is~     a severe complication leading to sepsis, permanent colostomy, higher risk of local cancer~     recurrence and eventually death. In order to prevent this complication a protecting diverting~     stoma is usually fashioned with consequent morbidity due to the stoma and its closure and~     severe impact on patients' quality of life. This prospective, multi-center, parallel-arm,~     randomized controlled equivalence trial is aimed to demonstrate whether a transanal~     reinforcement of the suture line can prevent anastomotic leakage after low rectal cancer~     surgery thus avoiding the need for a covering ileostomy~   "
98360|NCT02279758|"~     Neuroendocrine tumors are rare but recent data showed a relevant increase in its incidence.~     The Mammalian Target of Rapamycin (mTOR), one of most important area of research, has~     demonstrated be a therapeutic target in these tumors. The metformin has demonstrate in~     preclinical studies having an antineoplastic action by inhibiting the mTOR pathway, and may~     be an alternative treatment for this disease.~      Eligible patients for this study should have metastatic gastroenteropancreatic neuroendocrine~     tumors well differentiated (grade 1 or grade 2) and will be treated with metformin 850 mg~     every 12 hours, and each cycle will consist of 30 days. After 180 days of treatment the~     efficacy of metformin under the control of disease progression will be evaluated. As a~     secondary outcome the investigator will check the patient adherence to the treatment, the~     control of patient symptoms with functioning neuroendocrine tumor, and disease free survival.~     Also will be performed an analysis of immunohistochemical expression of mTOR pathway proteins~     of these patients.~   "
98361|NCT02279745|"~     This study is an open-label extension study to determine the long-term safety and~     tolerability of APD811 in patients with WHO Group 1 PAH who have completed the Phase 2 study,~     APD811-003. Patients must have completed the APD811-003 study and must meet eligibility~     criteria for APD811-007.~   "
98362|NCT02279732|"~     The purpose of the study is to determine whether Ipilimumab plus Paclitaxel and Carboplatin~     will extend the life of patients with squamous only non small cell lung cancer more than~     placebo plus Paclitaxel and Carboplatin.~   "
98363|NCT02279719|"~     This is an open label, three-arm, phase 1 dose escalation study and phase 2 study of BBI608~     in combination with sorafenib, or BBI503 in combination with sorafenib. The study population~     is adult patients with advanced hepatocellular carcinoma who have not received systemic~     chemotherapy.~   "
98364|NCT02279706|"~     Korean linguistic adaptation of Rhinitis controlled assessment test (RCAT).~   "
98365|NCT02279693|"~     This study evaluates the dose received by the prostate with in vivo dosimetry when delivering~     image guided radiation therapy (IGRT) associated with intensity modulated radiation therapy~     (IMRT) for patients with localized prostate cancer using two repositioning techniques:~     fiduciary markers or soft tissues.~   "
98366|NCT02279680|"~     The objective of this multidisciplinary project is to explore the deficit of associative~     memory in ASD (Autistic Spectrum Disorder) that could result from abnormal brain~     connectivity. The hypothesis of abnormal functioning of the fronto-hippocampal network has~     been evocated but has never been tested. Hence, the present project will include two~     complementary assessments conducted on a group of adults aged from 18 to 30 with ASD compared~     to a control group matched in chronological age and intellectual quotient. The first~     assessment is devoted to the study of associative memory and its EEG correlates and the~     second focused on the investigation of perceptual strategies related to associative memory~     using the technique of Eye-tracking. Both behavioral and imaging data would provide new~     insights on the relationship between perception and memory in ASD.~   "
98367|NCT02279667|"~     Single centre, open-label, randomised, three-way crossover study in 18 healthy subjects (9~     males and 9 females). The study consisted of three consecutive single-dose treatment periods~     separated by a washout period of 7 days or more. On each treatment period, the volunteers~     received a single dose of BIA 2-093 800 mg, orally.~   "
98368|NCT02279654|"~     This registry is a prospective, non-interventional, post authorisation safety study for~     patients diagnosed with Transfusion Dependent, IPSS low or intermediate-1-Risk~     Myelodysplastic Syndrome (MDS), associated to a single abnormality of the chromosome 5~     [del(5q)].~      The purpose of this study is to collect additional data about the safety of an oral drug~     (lenalidomide, Revlimid®) that may have been prescribed to relieve anemia and decrease the~     need of blood transfusions. However, also patients affected by the MDS del(5q) who receive~     other treatments different from lenalidomide can be included in this study, if they agree.~   "
98369|NCT02279641|"~     This is a Phase 1b, randomized, open-label, drug-drug interaction study in adult male~     subjects with gout. It is designed to assess the pharmacokinetics (PK) and pharmacodynamics~     (PD) of RDEA3170 or allopurinol alone and in combination in the fed state.~   "
98370|NCT02279628|"~     The cesarean section is considered as a painful surgery during the post operative period.~     Mothers may need to move immediately after the surgery to take care of their babies. This may~     increase the risk of major pain and chronic pain. Thus, excellent postoperative analgesia is~     required so that mothers do not experience pain in caring for their baby. Currently, several~     techniques have been developed to manage postoperative pain related to c-section scar such as~     intrathecal morphine during spinal anesthesia or continuous pre-peritoneal wound~     infiltration. The comparison between anesthetic techniques has never been performed and it is~     still not know if the combination of intrathecal morphine plus continuous pre-peritoneal~     wound infiltration provide a synergistic or additional effect on pain relief.~   "
98371|NCT02279615|"~     The purpose of this study is to investigate the safety and efficacy of combination therapy~     involving β3-adrenoceptor agonist, mirabegron, and α-blockers for the treatment of OAB~     symptoms in male patients with BPH.~   "
98372|NCT02279602|"~     Subjects achieving a clinical response in study OX4218s with a biomarker reduction or symptom~     response are eligible to enroll in this rollover study to continue once every three weeks~     fosbretabulin infusions for up to one year.~   "
98386|NCT02279420|"~     This is a multicenter, un-blinded, open label, pivotal supplemental study to G130163 intended~     to evaluate the safety and efficacy of treating previous sham subjects in the Essential~     pivotal trial (IDE#G130163) with the active treatment (the placement of g-Cath EZ suture~     anchors along with diet and exercise). Compliant sham subjects (those who attended all~     primary IDE follow-up visits AND who continue to meet eligibility criteria as described in~     this protocol) will be offered this active treatment after their 12 month unblinding visit in~     the Essential pivotal trial.~   "
98373|NCT02279589|"~     Immune response analysis after the combination of PCV13 and PPV23 will lead to evaluate if a~     prime with PCV13 help to obtain a good response to repeated dose of PPV23.The~     hyporesponsiveness following the unconjugated vaccine is associated with high polysaccharide~     antigen concentration. Several issues limit the development and recommendation of~     anti-pneumococcal vaccine in adult's patients at risk. Reduced doses of unconjugated~     polysaccharide antigens would bypass the hyporesponsiveness and maintain the expanded~     coverage serotype.~      A better knowledge of immune response following the combination of two vaccines in adults is~     essential. In addition, adults are required to be exposed to repeated doses of polysaccharide~     antigens by vaccine or by natural exposure, it is important to determine the extend and~     duration of any hyporesponsiveness.~      The main objective is to evaluate if non conjugate polysaccharidique fractionated doses~     administered after a conjugate vaccine help to avoid hyporesponse in a schedule with repeated~     injections of pneumococcal polysaccharidique vaccine~   "
98374|NCT02279576|"~     Penile cancer is an uncommon disease, with devastating physical and psychological effects on~     patients. Penile carcinoma even in advanced stages is responsive to several chemotherapeutic~     agents. However, due to the low incidence of penile cancer, no large studies have been~     reported concerning chemotherapy.~      Various single agents were tested for activity en penile cancer in de 70s and 80s. Response~     rates ranged from 10 to 27% with cisplatin, 20 to 21% with bleomycin, and 0-62% with~     methotrexate. These agents in combination were tested in different studies. Other~     chemotherapy schemes have been studied, as combination of cisplatin with 5 fluorouracil with~     or without taxol, and cisplatin plus irinotecan. All of them in limited phase II studies,~     with described higher responses rates in some of them but without results confirmation in~     phase III studies.~      In conclusion, tested regimens so far have not been very successful in advanced stages of the~     disease.~      Antiangiogenic therapy has been demonstrated effective in the treatment of similar cancer~     types as lung and head and neck, so it can be postulated that antiangiogenic therapy can be~     effective in the treatment of penile carcinoma. Pazopanib is a new potent oral antiangiogenic~     therapy.~      Cytotoxic agents, such as paclitaxel, when administered at low doses and frequent intervals,~     may exert antiangiogenic effects, thereby enhancing anticancer activity. Recently,~     combination of pazopanib and paclitaxel administered in a metronomic schedule (80mg/m2 weekly~     3 weeks every 4 weeks cycle) obtained a 40% response rate and an 80% of disease control in~     the first-line treatment of melanoma patients. Treatment was well tolerated.~      As paclitaxel and antiangiogenic drugs seem a very active treatment, combination of pazopanib~     and paclitaxel seems a good combination to be tested in patients with penile carcinoma.~   "
98375|NCT02279563|"~     This study is to evaluate the equivalence of generic Azelastine Hydrochloride and Fluticasone~     Propionate Nasal Spray with that of the marketed drug, Dymista™ Nasal Spray, in the treatment~     of seasonal allergic rhinitis, and to evaluate the safety and tolerability of generic~     Azelastine Hydrochloride and Fluticasone Propionate nasal spray compared with Dymista™ nasal~     spray.~   "
98376|NCT02279550|"~     The purpose of this study is to create an institutional and population-based registry of Hip~     fracture in the elderly with a prospective survey based on epidemiological data, risk~     factors, diagnosis, prognosis, treatment, monitoring and survival.~   "
98377|NCT02279537|"~     The purpose of this study is to collect real-life data on patients with wet age related~     macular degeneration (AMD) for whom treatment with Eylea was initiated~   "
98378|NCT02279524|"~     This is a multicenter, Phase IIb, randomized, double blind, placebo-controlled study designed~     to evaluate the efficacy and safety of two Aramchol doses in subjects that are 18 to 75 years~     of age, with Non-Alcoholic Steatohepatitis (NASH) confirmed by liver biopsy performed in a~     period of 6 months before entering the study, with overweight or obesity and who are pre~     diabetic or type II diabetic.~      Eligible subjects will be enrolled into three treatments arms: Aramchol 400 and 600 mg~     tablets and placebo tablets in ratio 2:2:1.~      The subjects will be evaluated at study sites for 11 scheduled visits during one year (52~     weeks). After completion of the study treatment period, the subjects will be followed for an~     additional period of 13 weeks without study medication (until visit 11 (week 65)).~   "
98379|NCT02279511|"~     To Check whether systemic treatment with ATP alters the profile of cerebral metabolism in~     patients with Alzheimer's disease using MRS techniques (Magnetic Resonance Spectroscopy) and~     adjust the infusion (minimum effective dose) that promotes this metabolic change.~   "
98380|NCT02279498|"~     Liprotamase powder is a non-porcine, soluble and stable mixture of three digestive enzymes~     including lipase, protease, and amylase. The purpose of the present study is to provide~     additional efficacy and safety data compared to approved, porcine-derived, enterically-coated~     and encapsulated pancreatic enzyme replacement therapy. The primary efficacy endpoint of the~     study will be comparative efficacy measured as the change in the coefficient of fat~     absorption (CFA) in Cystic Fibrosis patients with exocrine pancreatic insufficiency (EPI).~      Liprotamase is stable in stomach and digestive fluids allowing administration in a variety of~     convenient formulations and with a number of foods without enteric coating.~   "
98381|NCT02279485|"~     This is an open-label, 2-arm, single-dose, randomized crossover study. The study will enroll~     a total of 100 subjects (2 arms with 50 subjects in each arm). In Arm 1, bioequivalence~     between the oral suspension and tablet formulations of perampanel will be evaluated under~     fasted conditions; in Arm 2, bioequivalence between the oral suspension and tablet~     formulations will be evaluated under fed conditions. In both study arms, subjects will be~     randomized on Study Day 1 for Treatment Period 1 to receive a single 12-mg dose for~     perampanel as either oral suspension or a tablet, and will then receive the alternative~     treatment on Study Day 43 of Treatment Period 2. Drug administration will be separated by a~     washout of at least 6 weeks between the two treatment periods.~   "
98382|NCT02279472|"~     The purpose of this study is to analysis changes in anterior segment morphology after laser~     peripheral lrldotomy measured by optical coherence tomography, and to evaluate treatment~     effectiveness~   "
98383|NCT02279459|"~     The purpose of this study is to utilize dual-energy computed tomography (DECT) to investigate~     changes in tumor iodine concentration in patients with head and neck squamous cell carcinomas~     (HNSCC). Dual-energy computerized tomography could easily replace a standard CT neck with the~     added benefit of providing functional information that would only be possible with advanced~     computerized tomography perfusion, magnetic resonance diffusion (MRI) or positron emission~     tomography (PET) imaging techniques.~   "
98384|NCT02279446|"~     Development of a validated computer-based instrument (software program) for the assessment of~     intermediate visual acuity.~   "
98385|NCT02279433|"~     DS-6051b is an orally administered inhibitor of the tyrosine kinases (ROS1) and neurotropic~     tyrosine kinase receptors (NTRK). This phase 1 first-in-human study evaluates safety and~     tolerability of DS-6051b in cancer subjects and identify a recommended phase 2 dose (RP2D).~     In addition, this study will also assess the pharmacokinetic (PK)/pharmacodynamic (PD)~     profiles and preliminary efficacy of DS-6051b.~   "
98389|NCT02279381|"~     Neonatal mortality has been a notable health issue in Pakistan. Considering the importance of~     the issue and well recognized interventions the investigators are proposing a randomized~     controlled trial in a rural district of Pakistan which will evaluate the effectiveness of a~     neonatal package comprised of the standard neonatal care, Kangaroo Mother Care (KMC) and~     application of chlorhexidine compared with standard neonatal care coupled with application of~     chlorhexidine and essential neonatal care alone. The investigators anticipate that this study~     will provide an evidence base way forward benefiting the children of Pakistan.~   "
98390|NCT02279368|"~     In Northern India, skewed sex ratios, female feticide and higher child mortality rates for~     girls have become serious concern. The female child mortality as a result of son preference~     have increased during the last several decades. Since families cannot know the sex of the~     fetus due to Indian government policies, they now 'neglect' girl child to ensure there are~     few survivors. Survival chances of second and third daughters are plunging neglecting~     healthcare and nutrition has become tool for death as 'good riddance'.~   "
98391|NCT02279355|"~     The aim of this retrospective study is to overall evaluate and validate preoperative and~     intra-operative risk factors for postoperative pressure ulcers in critically ill~     postoperative patients.~   "
98392|NCT02279342|"~     The purpose of this study is to investigate the effects of febuxostat on coronary plaque~     volume in patients with chronic stable angina and hyperuricemia.~   "
98393|NCT02279329|"~     Subjects male and female aged 50-85 with a clinical diagnosis of chronic obstructive~     pulmonary disease (COPD) or Bronchiectasis, or those with ≥ 10 pack/years smoking history~     will be imaged with CT and MRI for the development of tools to quantify and validate~     longitudinal in vivo magnetic resonance imaging phenotypes of COPD and Bronchiectasis.~   "
98394|NCT02279316|"~     Move for your mind is a single blind, 3-arm randomized controlled clinical pilot trial. The~     study aims to test the effect of a weekly Dalcroze eurhythmics program (arm 1) and a home~     strength exercise program (arm 2) against control (no exercise) on the rate of falling,~     quality of life, gait performance and cognitive function. All groups receive vitamin D. In~     addition the study shall test the feasibility of the recruitment and the interventions in~     this target population.~      The study includes 60 seniors, age 65 and older, with mild cognitive impairment or mild~     dementia. Participants are recruited by the memory clinic of City Hospital Waid.~      During the 12 months follow-up, participants will have 3 clinical visits (baseline, 6 and 12~     month). Despite major efforts the target population is very difficult to recruit and~     adherence to treatment is low. We therefore decided to stop recruitment and to use this trial~     as a pilot trial for future clinical trials of the same topic.~   "
98395|NCT02279303|"~     This randomized controlled trial will test the impact of a patient-navigated,~     anti-inflammatory, culinary-based intervention (reinforced by motivational interviewing [MI]~     and tailored newsletters) on obese (body mass index [BMI] 30+), early-stage (0-IIIA) breast~     cancer survivors compared to a control group.~   "
98396|NCT02279290|"~     This randomized controlled trial uses a modularized cognitive behavioral resilience training~     (MCBRT) intervention to probe risk and resilience mechanisms linked to post-trauma~     psychopathology. Ninety participants with a history of interpersonal trauma during childhood~     or adolescence and mild to moderate distress will be randomized to MCBRT or a health~     education control condition. The primary aims of this proposal are to examine whether~     individuals who receive MCBRT demonstrate increases in psychological resilience, biological~     resilience, and extinction learning compared to those in the control group. This study will~     also explore associations between these psychobiobehavioral risk and resilience factors.~   "
98397|NCT02279277|"~     In this study, the investigators are investigating the effects of physical therapy (PT) for~     treating high grade knee osteoarthritis (OA) in patients that are candidates for total knee~     replacement. Through the examination of patient outcomes, such as pain, stiffness, and~     physical function, the investigators will determine if PT prior to total knee replacement is~     an effective treatment in a patient with high grade OA.~   "
98398|NCT02279264|"~     Objectives:~        1. To validate the accuracy of pH measurements of gastric fluid by comparing the readings~          from the RightSpot Infant pH Indicator to a standard clinically approved pH monitor~        2. To determine what percentage of time the RightSpot Infant pH Indicator could have been~          used to determine the proper placement of the NG tube prior to feedings~        3. To establish normative pH values for neonates~   "
98399|NCT02279251|"~     The study will evaluate two group CBT interventions delivered by school health nurses, in~     cooperation with community psychologist and mental health care personnel, to adolescents with~     mild to moderate levels of anxiety symptoms. The two interventions have different intensity~     (5 versus 10 group meetings). The two group interventions will be compared to a waitlist~     control group.~   "
98400|NCT02279238|"~     In view of assessing the uphill walking capacity and to provide a functional stress test with~     better sensitivity the investigators need a short term functional stress test over the gold~     standard six minute walk test....~      To demonstrate the significance of 3 minutes ramp walk test over 6 minutes walk test as a~     functional stress test.~      The investigators hypothesize that the investigators three minutes ramp walk test (3MRWT)~     will be superior to the existing six minutes level walk test (6MWT) in the measurement of~     functional capacity of post valve replacement patients.~   "
98413|NCT02279069|"~     Stroke patients frequently necessitate walking aids such as 4-point canne. However, the~     4-point canne has to be lifted by the patient which limited gait speed. The adjunction of~     small wheel below the 4 point of the canne (4-roll) gives the possibility to the patient to~     walk without having to lift the canne as it will roll over the ground.~      The aim of our study is to compare gait parameters (gait speed and energy cost) with a~     classical 4-point canne and with 4-roll canne.~   "
98414|NCT02279056|"~     Obstructive sleep apnea (OSA) is a common sleep disorder treated with continuous positive~     airway pressure (CPAP). Some OSA patients also suffer from co-morbid insomnia. CPAP treatment~     may be complicated in patients with co-morbid insomnia. This project evaluates the effects of~     a self-help book for insomnia in patients being treated with CPAP for OSA.~   "
98849|NCT02273388|"~     The primary objective of this trial is to identify the maximum tolerated dose (MTD) of BI~     6727 therapy in terms of drug-related adverse events. Secondary objectives are the collection~     of overall safety and antitumour efficacy data and the determination of the pharmacokinetic~     profile of BI 6727.~   "
98401|NCT02279225|"~     Temporomandibular joint dysfunction is described as a multifactorial disease and can be~     directly linked to other diseases, being of structural factors of the Stomatognathic System~     or not, such as fibromyalgia. Studies show the interconnection of Temporomandibular~     Dysfunctions with fibromyalgia. Thus, this project aims to evaluate the effect of~     Phototherapy on fibromiálgicos patients with temporomandibular dysfunction This is a~     Randomized, Controlled and double-blind, with the intention to treat. In this way the sample~     of 61 patients with Fibromyalgia, Temporomandibular joint Dysfunction associated with ages~     between 35 to 58 years, females who are selected after the inclusion/exclusion criteria, will~     be randomly distributed in homogeneous groups and the placebo group (P), Phototherapy (FT)~     group, group of physical activity (A) aerobic and aerobic physical activity + Phototherapy~     Group (FT + A). Will be used as a means of analysis before and after interventions the~     following parameters: Pain: clinical evaluation, evaluation of pain by Visual analog scale of~     pain (EVA), McGill Pain Questionnarire and pressure Algometria. Still we will evaluate the~     dosage of serotonin, indirectly, by saliva. Quality of life: own illness as questionnaires~     FIQ (Fibromyalgia Impact Questionnaire), Medical Outcomes Study 36-item Short-Form Health~     Survey SF-36 and also will assess the quality of sleep, with polysomnography. The treatments~     will total in 10 sessions held twice a week, and the FT and FT + groups to receive~     Phototherapy enforcement will be used a portable cluster 9 diodes, where will be delivered~     39.3 Joules in tender points of fibromyalgia and TMJ, groups and FT + to carry out aerobic~     activity in 75% of your MHR for 50 min and the P group will receive the application of~     Phototherapy of 0 Joules (IE, the equipment does not emit any power). Statistical analysis~     will be compared using the t test intra-group-Student, one-tail and paired and can be used~     the Kruskal-Wallis test, the statistical analysis of significance 0.05 for both tests.~   "
98402|NCT02279212|"~     Previous research on intensive care unit (ICU) survivors shows that rehabilitation is~     challenging, because of patients experiences of disease related problems both under and after~     treatment. Approximately 20 % of patients die within hospital, up to 80% suffer from~     hallucinations and nightmares, deal with paranoiac experiences, chronic pain and other~     symptoms and disability (Angus et al 2004; De Letter et al 2001; Ely et al 2001; Nelson et al~     2006; Van den Berghe et al 2001; Van den Berghe et al 2003) . A recent study shows that 28%~     of intensive care survivors have chronic pain that reduce their health related quality of~     life (Boyle et al 2004).~      The aim of this study is to perform a survey about prevalence of pain type, and which~     consequences this causes when it comes to function and quality of life up to 12 months after~     the ICU stay.~        1. What type of pain has ICU survivors and how do pain change over time, related to~          treatment/rehabilitation and the illness' development?~        2. What is the relationship between different pain characteristic, quality of life,~          anxiety, depression, fatigue, sleep and PTSD in these patients?~        3. What is these patients largest obstacle for good QoL after discharge from hospital?~   "
98403|NCT02279199|"~     The purpose of this study is to find out if gross motor skills of children and young adults~     with bleeding disorders are different from those without bleeding disorders. The~     investigators will use the standardized motor test the Bruininks-Oseretsky Test of Motor~     Proficiency, Second Edition (BOT-2 tm). The second purpose is to establish if history of~     joint disease secondary to bleeding affects gross motor skills.~        1. Participants and setting: Subjects will include up to 100 male youth and young adults,~          ages 4 to 21, recruited from the patient population of the Hemophilia Treatment Center~          at OHSU. A mailing that describes the study may be sent to all potential subjects who~          receive care through the Hemophilia Treatment Center at OHSU. Data collection will occur~          at either clinic visits or in the home. Information, including history of change in~          joint structure and synovium, from existing bleeding disorder repositories at OHSU will~          also be used.~        2. Design and Procedures: Research will be done using a prospective, cross-sectional study~          design to examine any relationship between a diagnosis of bleeding disorder and gross~          motor development. The gross motor ability of children and young adults with bleeding~          disorders who meet the inclusion criteria will be compared to sex-specific normative~          data from a standardized motor test. Information about age, type of hemophilia, presence~          of an inhibitor, type of management used, body composition, range of motion, and hand~          strength will also be collected through direct measurement and chart review. The~          information collected will be entered into a repository. A subject may choose to opt out~          of the repository while still participating in the research study. In addition,~          information from a current hemophilia repository will be compared to gross motor ability~          scores to determine if joint disease is related to skill level in this group of people.~        3. Proposed analyses: Two-tailed t tests and logistic regression will be used to determine~          if there are any significant differences.~   "
98404|NCT02279186|"~     In this study, the efficacy and safety of tranexamic acid in the reducing the blood loss~     during and after elective LSCS will be investigated.~   "
98405|NCT02279173|"~     This is a phase 3b single arm, open label, multicenter study describing the percentage of~     time pediatric subjects with ITP have a platelet response while receiving romiplostim,~     defined as a platelet count ≥ 50 x 10^9/L and in the absence of ITP rescue medications in the~     past 4 weeks.~   "
98406|NCT02279160|"~     The study will be conducted as a placebo-controlled, randomized, 22 week double-blind study~     which will include a dose titration period. An additional transition period will occur for~     those patients who elect to enroll into the open-label extension study, APD811-007.~     Approximately 60 patients with PAH will be enrolled.~   "
98407|NCT02279147|"~     RATIONALE:Anticholinesterase drugs and cholinergic M receptor antagonist are applied to~     patients who have obstructive jaundice after operation.~      PURPOSE:This clinical trial was designed to lower the incidence and mortality of operation~     complications in patients with obstructive jaundice .~   "
98408|NCT02279134|"~     This phase III trial is studying how well the combination of chemoradiation or radiation~     works in resected locally advanced cancer of the esophagus or gastroesophageal junction.~   "
98409|NCT02279121|"~     The purpose of this study is to compare the efficacy of a lock taurolidine-citrate solution~     vs standard saline solution for primary prevention of central venous catheter-associated~     bloodstream infection in adult patients treated with intra-venous therapy for a solid tumor~   "
98410|NCT02279108|"~     The sentinel node has a fundamental role in the management of early breast cancer.~      Currently, the double detection of blue and radioisotope is recommended. A radioactive~     material requires the presence of a nuclear medicine department and the approval of health~     authorities. In many centers, this technique is not available. The use of blue is easier to~     implement technique. However, allergic reactions and prolonged breast tattoo led many teams~     to stop the practice.~      So in common practice, many center use a single method. However, with a single detection, the~     risk of false negatives and the identification failure rate increased to a significant extent~     and the number of sentinel lymph node detected and removed is not enough.~      Under these conditions, find another method of detection seems crucial. According to the~     literature, the fluorescence method (ICG) is a technique that seems safe and reliable.~      The investigators therefore propose a prospective, randomized study to investigate the~     interest of fluorescence associated with the isotopic method.~   "
98411|NCT02279095|"~     Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease~     characterized by heterotopic ossification (HO) often associated with painful, recurrent~     episodes of soft tissue swelling (flare-ups) that lead to ankyloses of major joints with~     cumulative and irreversible loss of movement and disability. In this study, the ability of~     palovarotene to prevent HO formation will be evaluated.~   "
98418|NCT02279004|"~     Tumor genotyping has become an essential biomarker for the care of advanced lung cancer and~     melanoma, and is currently used to identify patients for treatment with targeted kinase~     inhibitors like erlotinib and vemurafenib. However, tumor genotyping can be slow and~     cumbersome, and is limited by availability of tumor biopsy tissue for testing. The aim of~     this study is to prospectively evaluate a blood-based genotyping tool that can quantify the~     presence of oncogenic mutations (EGFR, KRAS, BRAF) in patients with lung cancer and melanoma.~     This assay is being studied both as a diagnostic tool for classifying patient genotype, and a~     serial measurement tool for quantification of response and progression on therapy.~   "
98419|NCT02278991|"~     Objective of this study is to evaluate the safety and efficacy of Lutonix 035 Drug Coated~     Dilatation PTA Catheter with Bard LifeStent Vascular Stent (hereinafter referred to as~     LifeStent) for treatment of long (10-24 cm) lesions in the SFA and/or proximal popliteal~     artery.~   "
98420|NCT02278978|"~     BIBF1120 in patients with advanced FGFR3 mutated, FGFR3 overexpressed, or FGFR3 wild type~     urothelial carcinoma of urinary bladder, urethra, ureter, and renal pelvis and who have~     failed platinum-based chemotherapy.~   "
98421|NCT02278965|"~     The purpose of this study is to determine whether it is feasible to give a combination of~     Metformin and omega-3 fatty acids for one year to women with a history of early stage breast~     cancer. We will also evaluate whether the metformin and omega-3 fatty acids combination~     causes changes in breast tissue, blood, and mammograms.~   "
98422|NCT02278952|"~     This is a non-interventional cohort study to assess a novel assay to detect excessive or~     insufficient immunosuppression from the drug tacrolimus in lung transplant recipients. The~     assay measures mean residual expression (MRE) of genes downstream of NFAT, a transcription~     factor regulated by tacrolimus. The investigators will assess whether MRE levels identify~     subjects at risk for rejection (insufficient immunosuppression) or infection (excessive~     immunosuppression).~   "
98423|NCT02278939|"~     Filipino Americans (FA) are the second largest (3.4 million) Asian group in the US. and have~     one of the highest prevalences of obesity and type 2 diabetes mellitus compared to~     non-Hispanic whites, African Americans and Hispanics. However, FA have been underrepresented~     in health related research, particularly in diabetes prevention. This proposed pilot study is~     the first clinical trial to assess preliminary estimates of the short-term effect of the~     novel social networking diabetes prevention program lifestyle intervention for this high-risk~     population.~   "
98424|NCT02278926|"~     Aim/hypothesis: Subcutaneous insulin absorption is one of the factors which strongly~     influence blood sugar control in patients with diabetes mellitus on insulin therapy. In~     response, a regular absorption is influenced by lipo-hypertrophy in subcutaneous tissue on~     injection sites. So far lipo-hypertrophy diagnosis has only been clinical since there are no~     imaging studies that have characterized precisely morphometry of lipo-hypertrophic tissue.~     Methods: In two groups of 20 type 1 diabetes patients on insulin therapy, lipo-hypertrophy is~     characterized and defined by clinical tapping or by ultrasound with multi frequency linear~     probe (6-18 Mhz). Patients are therefore advised to avoid insulin injections on those areas~     so defined. Patients are reevaluated 3 and 12 months later~   "
98425|NCT02278913|"~     Few randomized studies have focused on the optimal management of non-ICU patients with type 2~     diabetes in Latin America. Objective: Compare safety and efficacy of a basal bolus regimen~     with analogs and human insulins in general medicine patients admitted to a University~     Hospital in Asuncion, Paraguay.~   "
98426|NCT02278900|"~     Aims of study While various communication aids have been evaluated separately, no studies~     have taken a coordinated approach combining aids with different goals to evaluate their~     combined impact. In this study the investigators will use two communication aids; a QPL and~     an audio recording of the consultation. QPLs includes question concerning treatment options,~     but few studies involving QPLs have explored whether QPLs result in patients taking a more~     active role in the consultation. To our knowledge there have not been studies which~     objectively try to explore whether patients receiving QPLs participates in shared decision~     making to a greater extent, except for one ongoing Italian trial of breast cancer patients.~      To explore and describe how communication aids as a QPL and an audio recording of the~     consultation improve the first doctor-patient consultation at the oncology outpatient clinic~     by~        1. Encouraging patients/caregivers to ask more questions, particularly about sensitive~          topics such as prognosis (as an effect of QPL alone)~        2. Increasing shared decision-making (as an effect of QPL alone)~        3. Improving overall satisfaction with the consultation and information retrieved (as an~          effect of both communication aids)~        4. Affecting quality of life/anxiety/depression (as an effect of both communication aids)~   "
98427|NCT02278887|"~     In this randomized controlled phase III study the investigators will evaluate whether TIL~     infusion preceded by non-myeloablative chemotherapy and followed by high dose bolus~     interleukin-2 can result in an improved progression free survival when randomly compared to~     ipilimumab in 168 stage IV melanoma patients. A health technology assessment (HTA) will be~     performed to evaluate the impact of the TIL treatment on patients and organizational~     processes and cost-effectivity.~   "
98428|NCT02278874|"~     The objectives of the clinical study are to demonstrate the accuracy of our proprietary~     algorithm method to determine the genetic health of the developing fetuses in a multiple~     gestation pregnancy from a maternal blood sample. The long term goal of this study will be~     the development of a method of minimally invasive prenatal diagnosis that has a higher~     sensitivity and lower false positive rate in the intended population (e.g. multiple gestation~     pregnancies) than other currently available screening tests.~      This will result in fewer unnecessary amniocenteses and CVS procedures, which are associated~     with a risk of miscarriage.~   "
98449|NCT02278601|"~     Epidural analgesia is the gold standard of pain relief for labour pain. Despite this, more~     than 50% of parturients continue to experience pain leading to suffering and increased~     caregiver workload. Women who have increased pain tend to have lower successful patient bolus~     demands when patient controlled epidural analgesia (PCEA) is utilised and have dysfunctional~     labour requiring obstetric intervention such as Caesarean or instrumental delivery. Labour~     pain often escalates and worsens as labour progresses requiring an individualized, variable,~     flexible analgesic regimen. Bolus epidural administrations have been shown to improve uniform~     spread of local anaesthetics with better pain relief, compared to fixed background infusions.~   "
98429|NCT02278861|"~     Actinic keratosis (AKs) are premalignant disorders that can evolve into skin cancer. To~     prevent their development, a study is being conducted with oral isotretinoin and topical~     tretinoin to verify what drug is the most effective and has the best security profile for~     these patients. Along with these treatments, cryotherapy with liquid nitrogen and sunscreens~     will be part of the treatment. The study will have the duration of 10 months. In the first~     four months, the AKs will be counted and treated with cryotherapy (face and arms) and~     sunscreens FPS 60 will be used. After it, the patients will return (the AKs will be counted),~     a new session of cryotherapy will be performed and they will be randomized into two groups:~     one group using oral isotretinoin 10mg/day ( ISO: 30 patients) and the other one using~     tretinoin 0,05% cream (AR: 30 patients) applied on face and arms. Skin biopsies will be done~     for all 60 patients at the beginning of the treatment with retinoids (isotretinoin and~     tretinoin). After six months of treatment with retinoids, the study will be stopped, AKs will~     be counted again and skin biopsies will be done. Patients in the group ISO (oral~     isotretinoin) also have to make blood tests at the beginning, two months and after six months~     of the treatment. Clinical (AK counting), histological (improvement of parts of the skin) and~     immunohistochemical parameters will be evaluated to see what drug is more effective for~     prevention of AKs.~   "
98430|NCT02278848|"~     Idiopathic chronic adult hydrocephalus (ICAH) is due to expansion of the fluid-filled~     cavities in the brain. The clinical symptoms are gait disturbance, mental decline and~     incontinence. Treatment involves installing a ventriculoperitoneal shunt which is known to be~     able to induce regression of the symptoms in many cases meaning that ICAH is a classic,~     curable cause of dementia. Diagnosis relies on comparing symptoms before and after depleting~     cerebrospinal fluid (CSF) via a lumbar puncture (LP). In practice, the situation is~     complicated: improvement is often incomplete and there is no consensus on either how to~     assess the symptoms or how they change after CSF depletion. In consequence, the decision~     whether not to undertake surgery often depends on the neurosurgeon's clinical impression.~      Over recent years, the cognitive profile of patients with ICAH has become better~     characterised and reproducible, objective techniques have been developed to assess motor~     function and CSF flow in the brain.~      The investigators project aims to define the value of these new investigative techniques in~     the positive diagnosis of ICAH, in comparison to current decision-making tools.~   "
98431|NCT02278835|"~     This trial was conducted to evaluate the effectiveness of the chest physiotherapy techniques~     to prevent pulmonary collapse based in an score applied in the patients submitted of the~     mitral valve surgery, after their ICU discharge.~      Patients were allocated in groups according their pulmonary function (FVC: forced vital~     capacity), the respiratory muscle performance (MIP: maximal inspiratory pressure; MEP:~     maximal expiratory pressure), the oxygenation level (SpO2), the pulmonary auscultation;~     respiratory frequency (f); the ability to expectorate and the functional independence.~      The group I was allocated those patients which presented decrease of up to 50% of forced~     vital capacity (FVC) of preoperative period, SpO2>92%, minimal pulmonary auscultation~     alterations; frequency (f) between 15 and 25 ipm; able to expectorate without assistance;~     independence to sit; respiratory. In these patients were randomized for two interventions: a)~     Deep breathing exercises: diaphragmatic exercises; inspiratory sighs; maximal inspiration~     exercises. Each kind of exercises was repeated 10 times; b) volume-targeted incentive~     spirometer: used Coach® three sets of 10 repetitions.~      Patients allocated in the group II presented FVC> 30% <49% of preoperative period, ≥ 88% SpO2~     <92%, necessity of oxygen therapy, abnormal pulmonary auscultation, f> 25 <31ipm; dependence~     to expectorate and to sit.. They were assisted by: a) Intermittent Positive Pressure~     Breathing (IPPB) with PEEP - through ventilator (Bird Mark 7™) with exhalation valve spring~     load set at 10 cmH2O. b) CPAP - 10 cmH2O associated with oxygen support to obtain SpO2≥ 95%~     with electronic device (Sullivan®) Each session consisted of 20 minutes, twice daily, one in~     the morning and another in the afternoon.~      All of the patients were conducted in effort to mobilize upper and lower limbs. On the first~     day, the patients walked at least 50 meters, by increasing the distance to at least 150~     meters on the fourth day. Outcome measures were recorded at day 5 of the interventions.~   "
98432|NCT02278822|"~     This trial is designed to provide evidence of the efficacy of liposomal glutathione~     supplementation on healthy adults. The investigators anticipate that liposomal glutathione~     supplementation will enhance the levels of blood glutathione and improve the immune~     functions.~   "
98433|NCT02278809|"~     1. Development of a method for parents of primary schoolchildren to teach parents parenting~          skills to obtain health gain in the family through videos and online feedback.~        2. Effect- and procesevaluation of this methodology.~        3. Development of an implementation guide together with VIGEZ as primary partner and in~          association with partner organisations on the field.~   "
98434|NCT02278796|"~     In the treatment of patient with lymphoma the most common high-dose chemotherapy regimen used~     prior to autologous transplantation (ASCT) is the BEAM regimen. It consists of four~     chemotherapy drugs together (BCNU, etoposide, cyclophosphamide, melphalan), whose initial~     letters are grouped together for BEAM regimen. One of the most common organ damage this~     intensive treatment is caused by the drug BCNU; it involves a lung injury, which manifests~     itself in the months after ASCT with increasing shortness of breath and cough, and can result~     in pulmonary fibrosis. The drug bendamustine is used successfully in different lymphoma~     types, and its efficacy in lymphoma therapy is well documented. Moreover bendamustine doesn't~     cause lung injury. Initially experience with bendamustine instead of BCNU - in the so-called~     BeEAM scheme - shows that this scheme is quite effective and well tolerated, without lung~     injury. In BeEAM scheme therefore bendamustine replace the BCNU, while the other three drugs~     are administered in the same dosage and order. The aim of the present study conducted at four~     centers (Bern and Zurich in Switzerland, Vienna and Salzburg in Austria) is to compare these~     two high-dose chemotherapy schemas and to show that the BeEAM scheme causes significantly~     less lung injury than the BEAM regimen.~   "
98435|NCT02278783|"~     This will be a non-blinded, single arm study to test the efficacy of Regorafenib in patients~     with recurrent ovarian, primary peritoneal, and fallopian tube cancer.~   "
98436|NCT02278770|"~     In this study, our novel MRI techniques for studying the small bowel will be applied to~     patients with diverticular disease. The ratio of visceral to subcutaneous fat will also be~     determined using MRI measurements. These data will be correlated with measurements of~     adipokines to determine if visceral fat has a specific influence on the severity of~     diverticular disease.~   "
98450|NCT02278588|"~     In this investigator-initiated study, we will compare changes in brain cognitive biomarkers~     assessed by diffusion tensor imaging over 2.5 years among 12 patients with Idiopathic~     Parkinson's disease (IPD) receiving rasagiline, 20 IPD patients not receiving MAO-B~     inhibitors and 25 age-matched healthy controls. Will also compare the changes in Mini-Mental~     State Exam (MMSE) and Montreal Cognitive Assessment (MoCA) scores and plasma brain-derived~     neurotrophic factor (BDNF) with changes in brain cognitive biomarkers in all IPD patients and~     HC over 2.5 years.~   "
98437|NCT02278757|"~     Randomised clinical trial with a 6-month follow-up in Mexican adult men and women (20-65~     years) with Metabolic Syndrome (MS). The sample size was calculated using a formula that~     compares two means, an alpha of 0.05 and a power of 95%. Based on these calculations, we~     established a baseline sample of 118 adults. For the diagnosis of MS, we used the~     classification from the International Diabetes Federation (IDF). 150 patients were screened;~     however, 32 were excluded because they did not meet the criteria. Doctors wrote down medical~     history; nutritionists conducted anthropometry (weight, height, and waist circumference); and~     nurses measured blood pressure and withdrew venous blood for determination of glucose,~     triglycerides, and HDL-cholesterol. After being randomly assigned to one of two groups, the~     control group received a diet with a lower protein content (0.8gr/kg body weight), and the~     intervention group received a diet with higher protein content (1.34gr/kg body weight). Both~     diets had equal amount of calories, were equivalent in the type of carbohydrate, and had a~     caloric restriction of 500 calories less.~      For the intervention group, meal replacements were made with soy protein, and individualized~     menus, controlling the content of calories, protein, carbohydrates, and fat, had more control~     over the total amount of protein consumed daily. Used as a substitute for food, the~     protein-enriched drinks were prepared with 250ml of either milk with 1.5% fat or just water.~     For both groups, the calorie density of the diet was adjusted for the baseline metabolic rate~     of each participant with a restriction of 500kcal/day.~   "
98438|NCT02278744|"~     This is a phase I clinical trial investigating the use of single fraction re-irradiation~     following local progression of spine and cauda equina (L2 to sacrum) lesions that have~     previously received radiation therapy. Patients will be treated with single-fraction~     radiation therapy at 3 dose levels using image-guided stereotactic radiosurgery techniques.~   "
98439|NCT02278731|"~     To determine and compare the effects of a training program with Pilates and Facilitation~     Neuromuscular Proprioceptive on balance and function in elderly women.~   "
98440|NCT02278718|"~     This study will be a two-arms study intending to demonstrate superiority of NexoBrid~     treatment over SOC in children with thermal burns. The study objective is to evaluate the~     safety and clinical benefit of NexoBrid in hospitalized children (0-17 years) with deep~     partial and/or full thickness thermal burns of 1-30% TBSA and to compare NexoBrid to standard~     of care (SOC).~   "
98441|NCT02278705|"~     The purpose of this study is to identify whether specific clinical practices—including~     attention to body-mass-index (BMI) screening/overweight/obesity, medical risk (from~     conditions associated with overweight/obesity such as high blood pressure), and following up~     to reassess progress—will improve the weight status of overweight school-age children.~   "
98442|NCT02278692|"~     Calcific uremic arteriolopathy a.k.a. calciphylaxis is a vascular calcification disorder seen~     in dialysis patients. Calcific uremic arteriolopathy has 60-80% one-year mortality and~     significant morbidity associated with non-healing and extremely painful skin lesions. At~     present, there is no effective treatment for calcific uremic arteriolopathy.~      Vitamin K is an important vitamin for inhibiting vascular calcification. It is known to~     increase the circulating levels of carboxylated Matrix Gla Protein, a potent inhibitor of~     vascular calcification. However, the effects of vitamin K supplementation in patients with~     calcific uremic arteriolopathy are unknown.~      The purpose of this study is to conduct a pilot randomized controlled trial to examine the~     effects of oral vitamin K supplementation on circulating levels of anti-calcification factor~     (carboxylated Matrix Gla Protein) and clinical outcomes in patients with calcific uremic~     arteriolopathy.~   "
98443|NCT02278679|"~     A digital rectal exam proficiency tool, titled the 'DiRECT' was developed based on the~     consensus of 10 experts. The purpose of this study is to validate this tool for use in both~     undergraduate and graduate medical education .~   "
98444|NCT02278666|"~     The aim of the present study is to assess in a real life case list the outcome of three~     different surgical approaches for isolated aortic valve surgery in terms of surgery times,~     morbidity and mortality.~   "
98445|NCT02278653|"~     The primary objective is to describe the functional outcome of patients that choose for organ~     saving treatment.~   "
98446|NCT02278640|"~     This is a prospective, non-randomized, single arm, multicenter, study to assess the initial~     clinical experience with the Harmonic ACE®+7 Shears by evaluating vessel sealing during total~     laparoscopic hysterectomy. The study will not modify or influence current surgeon technique.~     Investigators will perform each procedure using the device in compliance with their standard~     surgical approach and product labeling.~      The Harmonic ACE®+7 Shears is cleared for commercial distribution and will be used in~     accordance with approved product labeling. The Harmonic ACE®+7 Shears will be assembled,~     calibrated, and/or used in accordance with manufacturer design specifications, product~     instructions and guidelines~   "
98447|NCT02278627|"~     During fthe first postoperative days, physiotherapists supported patients with knee~     replacement in orthopaedics of Saint-Junien's and Limoges' hospitals. This support includes~     movements of the leg in active and non active motions, without any help and with an~     arthromotor, and involves walking rehabilitation.~      The investigators would like to complete the physiotherapist's support with manual lymphatic~     drainage (MLD) using a specific method based on pressure of finger splayed (PFS). This might~     have a positive impact on time recovery of joint range, on postoperative oedema resorbtion~     and on patient's pain during rehabilitation classes.~      French National Authority for Health specifies there is not a single study assessing massage~     effects on knee replacement, according to current bibliography.~      The investigators purpose is the establishment of a prospective, controlled, randomised trial~     referred as a superiority trial. A total of 98 patients divided in 2 parallel groups will~     be created.~      The study will be in an open-label manner for both patient and physiotherapist involved in~     walk rehabilitation but will be conducted as a blinded study for the investigating~     physiotherapist.~      Inclusion period will be 17 months and the following period will be 6 weeks.~   "
98448|NCT02278614|"~     The objective of the study is to assess the efficacy and safety of T2347 (Latanoprost 0.005%~     + Timolol 0.5% unpreserved eye drops) versus Xalacom® in ocular hypertensive or glaucomatous~     patients initially treated, stabilised by Xalacom® or generics (fixed combination Latanoprost~     0.005% + Timolol 0.5% preserved eye drops).~   "
98850|NCT02273375|"~     The purpose of this study is to find out whether it is better to receive a new drug,~     MEDI4736, or better to receive no further treatment after surgery (and possibly chemotherapy)~     for lung cancer.~   "
98452|NCT02278562|"~     By 2030 an estimated 2 million people in the US will need dialysis or transplantation for~     advanced kidney failure. An even more disturbing statistic is that mortality in End Stage~     Renal Disease (ESRD) is six times higher than in the general Medicare population with~     adjustment for age, gender and ethnicity. Protein energy wasting is highly prevalent in these~     patients and is one of the most important determinants of their poor clinical outcome.~      Despite its well-recognized occurrence, the etiology and the mechanisms leading to protein~     energy wasting observed in chronic hemodialysis patients cannot be attributed to any single~     factor. However, irrespective of the specific etiologic mechanisms, it appears that the~     common pathway for all the metabolic derangements is related to exaggerated protein~     degradation relative to protein synthesis (47).~      Two well-recognized and presumably interrelated metabolic abnormalities, insulin resistance~     and chronic inflammation, may be the major determinants of protein catabolism in coronary~     heart disease (CHD) patients. There are no studies examining the effects of anti-inflammatory~     interventions and/or insulin sensitizers on protein homeostasis in CHD. Due to their~     established anti-inflammatory and other pleiotropic effects, Interleukin-1 receptor~     antagonist Anakinra and insulin sensitizer peroxisome proliferator-activated receptors (PPAR)~     agonist Actos represent two such promising interventions. By modulating inflammatory response~     and insulin signaling through two pharmacological interventions, the investigators will have~     the unique opportunity to clarify mechanisms contributing of these two particular metabolic~     derangements in the development of protein energy wasting observed in chronic hemodialysis~     patients.~      The overall goal is to elucidate the mechanisms by which chronic inflammation and insulin~     resistance influence the development of protein energy wasting in hemodialysis patients.~      Specific Aim: To test the hypothesis that inhibiting inflammatory response by administration~     of an Interleukin1receptor antagonist (Anakinra) or increasing insulin sensitivity by~     administration of a PPAR agonist (Actos) will improve net protein metabolism.~      Hypothesis: The chronic inflammatory component of protein energy wasting (PEW) observed in~     hemodialysis patients is, at least in part, mediated by insulin resistance.~      Interim analysis may be performed (no specific plan at this time).~   "
98453|NCT02278549|"~     Low back pain (LBP) is a complex and common problem with major societal repercussions.~     Clinical evaluations, and especially functional assessments, are necessary for proper~     diagnosis and decisions on the most appropriate treatment. The assessment of lumbar~     kinematics has been frequently described. For instance, measures of range of motion (ROM),~     angular velocities and acceleration of the total lumbar spine (TLx) have demonstrated some~     differences between healthy subjects and LBP patients. However, recent evidence has suggested~     that models evaluating the TLx are insufficient. In fact, regional differences in kinematics~     have been described between the upper lumbar spine and the lower lumbar spine.~      The aim of this study is to evaluate the differences in spinal kinematics between healthy~     subjects and LBP patients using a multi-segment model of the spine that allows regional~     analysis.~   "
98454|NCT02278536|"~     The objectives of the clinical study are to demonstrate the accuracy of our new NATUS~     diagnostic method to determine the genetic health of the developing fetuses in a multiple~     gestation pregnancy from a maternal blood sample. The long term goal of this study will be~     the development of a method of minimally invasive prenatal diagnosis that has a higher~     sensitivity and lower false positive rate in the intended population (e.g. multiple gestation~     pregnancies) than any currently available screening tests. This will result in fewer~     unnecessary amniocenteses and CVS procedures, which are associated with a risk of~     miscarriage.~   "
98455|NCT02278523|"~     Background：Respiratory muscle weakness is observed in chronic obstructive pulmonary~     disease(COPD) patients and contributes to hypercapnia, dyspnoea, nocturnal oxygen~     desaturation and reduced walking distance.During exercise it has been shown that diaphragm~     work is increased in COPD and COPD patients use a larger proportion of the maximal~     inspiratory pressure (MIP) than healthy subjects. This pattern of breathing is closely~     related to the dyspnoea sensation during exercise and might potentially induce respiratory~     muscle fatigue. Inspiratory muscle training(IMT) increases inspiratory muscle strength and~     endurance, and decreases dyspnoea.But the mechanism of IMT still lack of research.~      Purpose：The experiment is aim to compare of the similarities and differences of~     transdiaphragmatic pressure by detecting the transdiaphragmatic pressure of COPD patients and~     healthy volunteers in different intensity of threshold load conditions. Thus investigate how~     inspiratory muscle training works or mechanism in lung rehabilitation programmes of COPD.And~     emerging the theoretical basis of inspiratory muscle training from respiratory physiological~     mechanism.~   "
98456|NCT02278510|"~     Topotecan is a FDA-approved drug when given by intravenous injection, but it is not effective~     against brain tumors when given intravenously. The Cleveland Multiport Catheter is a new,~     investigational device that will be used to deliver topotecan directly into participants'~     brain tumors. One purpose of this study is to determine whether the Cleveland Multiport~     Catheter can be used effectively and safely to deliver topotecan directly into brain tumors.~     This study will also evaluate different doses of topotecan that can be delivered to a~     participant's brain tumor with use of the Cleveland Multiport Catheter, and it will also~     examine how their tumor responds to treatment with topotecan.~   "
98457|NCT02278497|"~     The study will assess coronary flow reserve by PET-H215O and FFR in patients suspected of~     coroanry artery disease. This a comparative study with dynamic acquisition using CZT camera~     and 99mcTc-mibi. 20 patients will have those measurements.~   "
98458|NCT02278484|"~     Safety and effectiveness of sinus balloon dilation in patients 2-21 years old.~   "
98459|NCT02278471|"~     In this study the investigators will examine the effect of the polypill on medication~     adherence, systolic blood pressure, and LDL cholesterol over a 12 month span.~   "
98460|NCT02278458|"~     Research Hypothesis: icotinib administered in combination with gemcitabine has an acceptable~     safety profile in subjects with locally advanced, unresectable or metastatic pancreatic~     adenocarcinoma.The primary objective is to determine the safety profile of icotinib in~     combination with gemcitabine in subjects with locally advanced, unresectable or metastatic~     pancreatic adenocarcinoma.~   "
98461|NCT02278445|"~     Doppler signals can be recorded from the lung parenchyma by means of a pulsed Doppler~     ultrasound system incorporating a special signal processing package- the Transthoracic~     Parametric Doppler (TPD) (Echosense Ltd., Haifa, Israel). Systemic sclerosis patients often~     develop pulmonary vascular disease leading to pulmonary hypertension. The TPD system may~     provide important insight into pulmonary blood vessels characteristics by the LDS (Lung~     Doppler Signals) signals that are related to pulmonary hypertension. The TPD performance in~     detecting PAH in SSc patients will be assessed in the study.~   "
98489|NCT02278081|"~     Gastroesophageal(GERD) reflux disease is a very common problem among pediatric population and~     has be proved to contribute in numerous otolaryngological manifestations. Trails of empirical~     treatment of antireflux medications is often used as a diagnostic test. However, the~     investigators believe GERD can cause rhinitis and nasal obstruction. Nasonex is considered as~     first line treatment for nasal obstruction. Hence, the proposed study aims to define the~     relationship between GERD and rhinitis using randomize control trial where one group of~     patients will receive nasonex and placebo, while the other group will receive nasonex and~     antireflux medications.~   "
98462|NCT02278432|"~     Introduction. The prevalence of the use of drugs that act on the gastric system has increased~     in the population. Omeprazole is an inhibitor of the protons pump and has a widespread use,~     mainly as a prophylactic to prevent reflux esophagitis, gastric pathological hypersecretory~     conditions, prevention of recurrence of gastric or duodenal ulcers, gastric mucosal~     protection against damage caused by nonsteroidal anti-inflammatory drugs and during~     Zollinger-Ellison syndrome. However, omeprazole is associated with several adverse events due~     to abusive use or irrational prescribing, in disagreement with the indication, which may~     cause the ineffectiveness of the drug and decreased patient safety. Objectives. To assess the~     risk (occurrence of adverse events) and the benefit (effectiveness) of the prophylactic use~     of omeprazole in hospitalized patients and to know the reasons for the prophylactic use~     (indicated use or not approved). Patients and Methods. A observational and cross~     pharmacoepidemiological study will be performed from June to November 2014, in the General~     State tertiary referral Américo Brasiliense Hospital. Hospitalized patients will be separated~     into three groups: those who make indicated and approved prophylactic use of omeprazole~     (exposed group 1), those who make not indicated and not approved prophylactic use (exposed~     group 2), and those who do not use the omeprazole (non-exposed group). Patients who do not~     make prophylactic use of omeprazole will be excluded. Patients will have their~     pharmacotherapy monitored and data will be collected daily using an investigation guide of~     the first day of admission and will be included in group 1 or 2, from the first use of~     omeprazole to discontinuation (washout period of seven half-lives or higher). National~     Coordinating Council for Medication Error Reporting and Prevention (NCCMERP) algorithm will~     be used for causality analysis is used. Data will be tabulated according to the presence or~     absence of effectiveness and the presence or absence adverse events in the three groups. The~     odds ratio of adverse events and effectiveness of indicated and approve or not indicated and~     not approved prophylactic use of omeprazole will be calculated. Expected results. It is~     intended to know the odds ratio of adverse events in the prophylactic use of omeprazole with~     or without indication or use approval, and the potential indications, dosage and unapproved~     methods of prophylactic use in omeprazole label.~   "
98463|NCT02278419|"~     The purpose of this study is to evaluate the efficacy of simeprevir in combination with~     sofosbuvir for 8 or 12 weeks versus a historical control, with respect to the percentage of~     participants with sustained virologic response at 12 weeks after end of treatment (SVR12) in~     the overall population.~   "
98464|NCT02278406|"~     The purpose of this study is to determine if deep brain stimulation can change brain oxygen~     levels in people with Parkinson's Disease. Measurements will be taken using a non-invasive~     device while subjects are both on and off their medications, and while their stimulator is in~     the on and off setting.~   "
98465|NCT02278393|"~     Investigate the safety of excessive consumption of plant sterol-enriched fermented dairy~     product over a 4-week period in Japanese healthy adults~   "
98466|NCT02278380|"~     This study is initiated to investigate the glycemic index value of seven food products.~   "
98467|NCT02278367|"~     This study is designed to expand the database of 18F-AV-1451 safety and tau binding as~     measured by PET imaging and to provide standardized conditions for 18F-AV-1451 use, data~     collection and analysis to facilitate companion studies including, but not limited to,~     longitudinal studies of aging, depression, and traumatic brain injury.~   "
98468|NCT02278354|"~     Subjects enrolled in the Professional Fighters Brain Health Study (PFBHS) will receive~     18F-AV-1451 to explore its use as a biomarker for brain injury related to repetitive head~     trauma and to examine the relationship between clinical presentation and tau deposition.~   "
98469|NCT02278341|"~     This study is conducted to explore a new therapy for anemia in patients with end stage renal~     disease (ESRD) on dialysis. Anemia is a reduced number of red blood cells or hemoglobin.~     Hemoglobin (which contains iron) is important for the transport of oxygen in your blood. The~     purpose of this study is to evaluate if roxadustat is effective and safe in the maintenance~     treatment of anemia in ESRD patients on stable dialysis. Roxadustat will be compared to~     epoetin alfa and darbepoetin alfa, commercially available medicines for treatment of anemia.~   "
98470|NCT02278328|"~     This is a single-site, randomized, acute dose-response study to determine whether STX209~     produces a dose-dependent significant change in MEG target parameters compared to baseline as~     well as compared to placebo treatment.~   "
98471|NCT02278315|"~     The primary objective of the study is to determine the safety and tolerability of~     I-131-CLR1404 as a single or multiple dose, with and without concurrent weekly dexamethasone,~     in patients with relapsed or refractory multiple myeloma who have previously been treated~     with, or are intolerant of, an immunomodulator and a proteasome inhibitor.~   "
98472|NCT02278302|"~     Study to investigate whether psychomotor performance which is necessary for safety driving a~     car or operating machinery and safely participating in daily life is changed by Aggrenox®.~     Also to investigate whether Aggrenox® impairs performance in combination with alcohol more~     than alcohol alone. Derived from this: Statement on whether a warning for drivers is~     necessary~   "
98473|NCT02278289|"~     The purpose of this study is to compare the efficacy of combining a wrist orthosis with~     either ultrasound therapy or paraffin bath therapy in treating carpal tunnel syndrome~     patients.~   "
98474|NCT02278276|"~     The purpose of this study is to determine the safety and benefits of SG1002, including~     overcoming deficits in circulating hydrogen sulfide and nitrite found in heart failure~     patients, with secondary endpoints focused on improving clinical endpoints.~   "
98475|NCT02278263|"~     Total knee joint replacement surgery can lead to significant blood loss, which can affect~     recovery after surgery. Tranexamic acid (TXA) is a medication which stops the breakdown of~     blood clots and therefore prevents blood loss. The optimal use of TXA remains a point of~     debate. Growing interest in the topical application of TXA (directly into the surgical wound)~     has been suggested as an alternative way of administering TXA, and may demonstrate similar~     effectiveness as when it is given intravenously. Therefore, this multicentred, randomized~     controlled trial, aims to investigate the safety and effectiveness of both topical and~     intravenous administrations of TXA in total knee joint surgery. The investigators predict~     that both routes of administration will demonstrate similar results when compared to placebo.~   "
98476|NCT02278250|"~     The purpose of this study is to evaluate the safety and tolerability of multiple ascending~     doses of single-agent M4344 administered twice-weekly (BIW), twice daily (BID) or once daily~     dose schedule in participants with advanced solid tumors. This investigation is a three part~     study examining M4344 alone and in combination with carboplatin, gemcitabine, and cisplatin~     to determine the safety and maximum tolerated dose.~   "
98477|NCT02278237|"~     Asthma and Chronic obstructive pulmonary disease (COPD) results in over a million~     hospitalizations in the United States annually1 and COPD is the third leading cause of 30-day~     re-hospitalizations.2 Clinical trials have established the efficacy of treatments primarily~     dispensed via respiratory inhaler devices that reduce morbidity and health care utilization~     if they are used correctly.3-4 Unfortunately, the effectiveness of these medications in~     real-world settings is limited by the fact that patients often do not use inhalers~     correctly.5-6 Current guidelines recommend assessing and teaching inhaler technique at all~     health care encounters, including hospitalization.77.5 My work has found that over 75% of~     hospitalized patients in an urban, predominantly underserved population misuse their~     respiratory inhalers, highlighting a missed opportunity to educate these patients with high~     potential to benefit.8 Hospitalization, therefore, provides a potential 'teachable moment' to~     correct this misuse.9 My preliminary data indicate that one strategy, in-person teach-to-goal~     (TTG), is effective in teaching hospitalized patients proper inhaler technique and is more~     effective than simple verbal instruction.10~      While TTG is a promising method to improve care for patients who use inhalers, several~     limitations prevent widespread adoption. First, TTG relies on in-person assessment and~     education, as well as training and monitoring instructors to ensure fidelity, making it~     time-consuming and costly. Also, because a single educational session does not ensure~     long-term retention,11-12 post-discharge reinforcement may be needed, which may be~     impractical with in-person TTG. One potential method to surmount TTG's limitations is use of~     interactive video module education (VME), a method that has been used for health education in~     other clinical contexts.13-14 Through iterative self-assessments and video-demonstrations on~     a tablet computer, VME has the potential to be less costly, maintain fidelity, and be more~     easily extended into the post-discharge setting than in-person TTG. However, certain~     questions remain about VME. It is unclear whether VME will yield similar results when~     compared to TTG, or whether urban, underserved patients will have the ability to, and be~     willing to use, VME in the post-discharge setting. Therefore, before widespread~     implementation of VME, it is critical to rigorously develop and test VME for inhaler~     education in the hospital setting. Ultimately, it will also be important to understand~     patients' ability and willingness to use post-discharge VME for educational reinforcement to~     allow for this strategy to transition patients across care settings from hospital to home.~     Through these funded projects, I will acquire critical data I need to develop R-01 studies~     focused on improving self-management for patients with obstructive pulmonary disease across~     care transitions.~      We hypothesize that interactive VME will lead to non-inferior rates of ability to demonstrate~     correct inhaler use compared to rates with TTG among hospitalized patients with Asthma or~     COPD.~      For this study we are testing the preliminary efficacy of VME to teach respiratory inhaler~     technique prior to implementing a larger RCT to test the comparative effectiveness of VME~     versus TTG.~   "
98490|NCT02278068|"~     The purpose of this research study is to collect information about a new treatment for Type 2~     Diabetes Mellitus (T2DM), using a medical device called the Metabolic Neuromodulation System~     which is intended to help regulate blood glucose levels in patients whose (T2DM) is not well~     controlled despite treatment with multiple medications. The medical device delivers low-level~     radiofrequency energy through the wall of the blood vessel to the liver to disrupt the nerves~     that lead to the liver. Previous research has shown that disrupting these nerves may lead to~     a lowering of blood sugar levels.~   "
98478|NCT02278224|"~     Group based cognitive behavioural therapy (CBT) is an effective treatment of depression,~     however, one third of patients do not respond satisfactorily (McDermut, Miller, & Brown,~     2001), and relapse rates around 30% have been reported from several studies (Butler, Chapman,~     Forman, & Beck, 2006).~      The present study compares group based CBT with rumination focused CBT for depression with~     respect to outcome and relapse.~      Rumination has been evidenced as a crucial vulnerability to depression (Smith & Alloy, 2009),~     predicting the onset, severity and duration of future depression (Nolen-Hoeksema, 2000).~     Depressed individuals show a negative bias in the perception of facial emotion, in the acute~     phase as well as in remission (Bouhuys, Geerts, & Gordijn, 1999), and display difficulties in~     disengaging from negative stimuli (Koster, De Raedt, Goeleven, Franck, & Crombez, 2005). In~     addition the present study investigate rumination and perceptual attention bias as potential~     key mechanisms underlying depression.~      128 depressed patients will be recruited and randomised for group based CBT or group based~     rumination focused CBT. Patients are assessed subsequently during treatment and at 6 month~     follow-up regarding depression, rumination, worry, negative perceptual bias, attention~     control. Results are expected at spring 2016.~   "
98479|NCT02278211|"~     This is a multi-centre observational study. It will make use of the positron emission~     tomography (PET) tracer 18F-sodium fluoride (18F-NaF) as a marker of coronary plaque~     vulnerability to detect culprit and non-culprit unstable coronary plaques in patients with~     recent myocardial infarctions. The investigators will then perform long-term follow-up of~     these patients to determine the prognostic significance of coronary 18F-NaF uptake~   "
98480|NCT02278198|"~     The purpose of the study is to find out if the small dose of radioiodine, that is used for~     the dosimetry study on patients with differentiated thyroid cancer, may stun the cancer cells~     and make the thyroid cancer treatment less effective.~   "
98481|NCT02278185|"~     This randomized phase II trial compares enzalutamide with standard androgen deprivation~     therapy in reducing incidence of metabolic syndrome in patients with prostate cancer that has~     spread to other places in the body. Metabolic syndrome is defined as changes in cholesterol,~     blood pressure, circulating sugar levels, and body weight. Previous studies have shown that~     patients with prostate cancer, who have been treated with standard medical therapy that~     lowers testosterone levels, have an increased risk of these changes. Hormone therapy using~     enzalutamide may fight prostate cancer by blocking the use of testosterone by the tumor cells~     instead of lowering testosterone levels. It is not yet known whether prostate cancer patients~     who receive enzalutamide will have reduced incidence of metabolic syndrome than patients who~     receive standard androgen deprivation therapy.~   "
98482|NCT02278172|"~     The primary aim of the study is to identify if vitamin D3 supplementation influences VO2max~     in athletes.~      Secondary aims are to determine if vitamin D3 supplementation impacts on measures of muscle~     function, lung function, body composition, immune function and the self-reported incidence of~     upper respiratory tract infection.~      This double-blind, randomised, placebo-controlled trial is of parallel design and will aim to~     recruit a total of 50 athletes randomised into either a placebo or treatment group for a~     12-week intervention.~   "
98483|NCT02278159|"~     The purpose of this study is to evaluate which home dialysis modality pattern (home~     hemodialysis [HHD], peritoneal dialysis [PD] or a combination of both, e.g. PD and then HHD)~     allows for the longest home dialysis survival, as defined by the time dialysed in a home~     environment. The investigators hypothesize that patients transferred from one home modality~     to another will have a longer home dialysis survival compared to patients treated only with~     PD or HHD.~   "
98484|NCT02278146|"~     A multi-center, open-label, prospective, feasibility study evaluating the ParaPatch System~     for the treatment of urinary incontinence and overactive bladder.~   "
98485|NCT02278133|"~     The purpose of this study is to assess the safety and anti-tumor activity of the triple~     combination of WNT974, LGX818 and cetuximab in BRAFV600-mutant mCRC with RNF43 mutations or~     RSPO fusions.~      The design of this study is based upon the translational and pre-clinical data that suggest~     that Wnt pathway signals, increased due to RNF43 mutations or RSPO fusions, cooperate with~     the EGFR and BRAF signals to maintain the growth of BRAFV600 CRCs. Inhibition of these~     signals with the triple combination of WNT974, LGX818 and cetuximab may result in anti-tumor~     activity.~   "
98486|NCT02278120|"~     This is a multi-center, randomized, double-blinded, placebo controlled trial in~     pre-menopausal women with advanced breast cancer.~   "
98487|NCT02278107|"~     A preliminary study to evaluate a new nasal interface and portable ventilator system in~     comparison to standard oxygen therapy in patients with severe chronic lung disease.~   "
98488|NCT02278094|"~     Background: OSAS is a type of sleep disorder characterized by intermittent, partial or~     complete upper airway (UA) collapse, seriously impacting sleep apnea and respiratory~     insufficiency. The major upper airway dilator muscle (genioglossus) is more active during~     periods of stable breathing compared with periods of cyclical breathing when obstructive~     apneas occurred. UA muscle strength is linearly related to the inspiratory pump muscle~     strength. The ratios of UA muscle strength (tongue protrusion, TP) and inspiratory pump~     muscle strength (PImax) were not different between individuals with and without OSAS.~     However, a highly wakeful ratio of TP force to PImax appears to be associated with a reduced~     propensity to moderate-to-severe OSAS. Up to 95% of OSAS cases are treated with continuous~     positive airway pressure (CPAP), which is the most effective, commonly used, and low-risk~     treatment method. However, patients using CPAP therapy could face ongoing difficulties. Aims:~     To evaluate the effects of home-based exercise for patients with moderate to severe OSAS.~     This study was a randomized clinical trial conducted at three different intervention~     protocols as experimental groups. We will use cluster random sampling assign to each group.~     CPAP treatment group will be the control group. Methods: Subject above 20 years old will be~     diagnosed to moderate and severe OSAS. Subjects will be assign to walking exercise (WE),~     Threshold Inspiratory Muscle Trainer (TIMT) and Tongue Muscle Trainer (TMT) treatment groups.~     We will compare the Polysomnography (PSG) data, Epworth Sleepiness scale (ESS), World Health~     Organization Quality of Life( WHOQOL) questionnaire is a shorter version of the original~     instrument (WHOQOL-BREF), 6-minute walking test (6MWD), rate of perceived exertion scale~     (RPE), flow-volume loop (FV-Loop), tongue and grasp muscle strength, anthropometric data and~     daily note at baseline, 3 months (end-of-intervention) and 6 months (post intervention~     follow-up) in patients with moderate to severe OSAS. They will undergo three months of the~     home-based exercises. Patients will be followed up with weekly telephone calls and be~     interviewed monthly. Expected results: By using the WE, TIMT and TMT therapies, the airway~     collapse during sleep will be prevented when the whole body muscle strength, inspiratory pump~     muscle strength and tongue muscle strength are enhanced.~   "
98491|NCT02278055|"~     The purpose of this study is to find out if Radium-223 is effective in reducing cancer pain~     within 12 weeks of treatment. In order to see if Radium-223 is effective, the patient's level~     of pain will be followed throughout the study.~   "
98493|NCT02278029|"~     This study will synthesize a behavioral profile of impaired driving performance for teenage~     patients with mild traumatic brain injury (mTBI), or concussion, from one week~     post-concussion to six weeks post-concussion. It will also elucidate the relation between~     decreased reaction times exhibited by these patients and their functional response to driving~     hazards. While a few studies have examined driving performance in adult patients with mTBI,~     to the investigators knowledge this will be the first investigation of driving performance~     for teenage patients with mTBI. Therefore, it will provide the foundation for the future~     development of return-to-drive protocols for physicians and clinical practitioners. This~     study will synthesize a behavioral profile of impaired driving performance for teenage~     patients with mild traumatic brain injury (mTBI), or concussion, from one week~     post-concussion to six weeks post-concussion. It will also elucidate the relation between~     decreased reaction times exhibited by these patients and their functional response to driving~     hazards. While a few studies have examined driving performance in adult patients with mTBI,~     to the investigators knowledge this will be the first investigation of driving performance~     for teenage patients with mTBI. Therefore, it will provide the foundation for the future~     development of return-to-drive protocols for physicians and clinical practitioners.~   "
98494|NCT02278016|"~     Bacterial meningitis is a potentially life-threatening disease that is associated with~     substantial neurological morbidity and mortality. Accurate diagnosis is essential to improve~     outcome and prevent antibiotic overuse. Here we try to explore new biological markers for the~     diagnosis of the central nervous system infection disease.~   "
98495|NCT02278003|"~     The goal of this study is to extend findings of propofol's effects on memory, as measured in~     volunteer research studies, to a clinical setting.~   "
98496|NCT02277990|"~     Medtronic , Inc. is sponsoring the World-wide Randomized Antibiotic Envelope Infection~     Prevention Trial (WRAP-IT), a randomized, prospective, multi-center, single blinded,~     post-market, interventional clinical study. This study will evaluate the ability of the TYRX~     envelope to reduce major CIED infections through 12-months post-procedure following CIED~     generator replacement, upgrade, revision, or de novo CRT-D implant. Additionally, this large~     device study provides the unique opportunity to prospectively characterize the performance of~     Medtronic's lead monitoring features in subjects whose CIED system includes a transvenous RV~     defibrillation lead. Finally, the WRAP-IT study will serve as a post-approval study for those~     geographies requiring a post-approval study of the TYRX envelope.~   "
98497|NCT02277977|"~     Microcirculatory disorders play a central role in the pathogenesis of sepsis and septic~     shock. Without adequate therapy that may lead to multi-organ failure and death. Therefore~     useful therapeutic measures aim to improve the microcirculation, to avoid tissue hypoxia and~     thus multiple organ failure or death. Clinically, the microcirculation can currently be~     indirectly evaluated using the diuresis and metabolic parameters (eg, lactate). The aim of~     the present study is to measure the microcirculation in septic shock by means of~     contrast-enhanced sonography of the calf muscles. For this purpose, the method is applied to~     24 subjects during and after septic shock. It will be investigated in this study whether the~     microcirculation measurement with ultrasound contrast reflects the severity of the disease.~     As well as to evaluate whether the use of this diagnostic method could lead to better~     treatment of the septic shock.~   "
98498|NCT02277964|"~     This is an observational study to develop new hypothesis regarding the dynamic and safety of~     switching from natalizumab to fingolimod:~        -  Comparison of disease activity (clinical and MRI) during the year after change of~          therapy in comparison to the year before change~        -  Dynamic of onset of disease activity after having stopped treatment with natalizumab~        -  Change of immunological parameters during treatment change from natalizumab to~          fingolimod in comparison to clinical and MRI measures~   "
98499|NCT02277951|"~     The aim of the study was to compare time and success rates of four intubation devices ( in a~     cardiopulmonary scenario with uninterrupted chest compressions with a standardized manikin~     model.~      The investigators hypothesized that fiberoscope laryngoscopes may improve success rates.~   "
98500|NCT02277938|"~     Several factors discourage the implementation of cancer screening to the population in~     general, which would result in earlier diagnosis and an expected improved survival.~     Concurrent in vivo and in vitro research has shown that drug acetylation activity is~     increased in cancer. Amantadine may be of value in detecting the presence of cancer.~     Accordingly, this study will examine how Amantadine is eliminated by the body in cancer~     patients. This is an important step in validating a cancer detection method that can be~     implemented economically for screening of large numbers of people.~   "
98501|NCT02277925|"~     Primary Aim:~      The primary aim of this randomized controlled trial (RCT) is to compare vaginal mesh and~     suture exposure rates in women undergoing robotic total hysterectomy and sacrocolpopexy with~     a light-weight polypropylene mesh (Upsylon™ y-mesh) using permanent (polytetrafluoroethylene,~     Gore-Tex) versus delayed absorbable monofilament (2-0 polydioxanone, PDS) sutures through~     1-year.~      Secondary Aims:~        1. To compare the 1-year composite success rate (leading edge of prolapse is at or above~          the hymen and apex has descended less than 1/3 of the vaginal length, no subjective~          feeling of bulge; and no retreatment for pelvic organ prolapse (POP) or vaginal mesh~          exposure) of permanent versus delayed absorbable sutures for mesh graft attachment~          during robotic total hysterectomy and sacrocolpopexy.~        2. To compare postoperative symptoms of pelvic floor disorders, including urinary~          incontinence, voiding dysfunction, pelvic organ prolapse, sexual dysfunction and quality~          of life between the 2 groups at 1 year.~        3. To evaluate adverse outcomes in each group, classified according to the Clavien-Dindo~          system.~   "
98502|NCT02277912|"~     The aim of the study is to evaluate the analgesic effects of navigated repetitive~     transcranial magnetic stimulation in central post stroke pain. MRI based navigation is used~     to determine the exact locations for stimulation.~   "
98503|NCT02277899|"~     The purpose of this study is to determine communication content and strategies in primary~     care that predict improvement in weight status among overweight school-age children.~   "
98608|NCT02276534|"~     The investigator's goal is to address the need for the development of social interventions~     for youth with autism in an innovative intervention, SENSE Theatre. The intervention blends~     established behavioral strategies with theatre techniques that emphasize the involvement of~     peers, play and performance. The resulting synergy extends promising pilot studies in a~     randomized group experiment.~   "
98504|NCT02277886|"~     Among those patients experienced GERD symptoms, up to 89% report nocturnal symptoms,~     resulting in poor sleep quality. Sodium alginate oral suspension (Alginos) is a medication~     indicated for the relief of gastroesophageal reflux symptoms. This multi-center, open-label,~     randomized trial intends to compare the addition of one dose Alginos (50mg/ml, 20ml) at bed~     time (Nexium plus Alginos), with no additional alginate treatment (Nexium alone), in erosive~     GERD patients taking Nexium (40mg/tablet) daily for 4 weeks. Efficacy endpoints include~     percentage of patients with relief or complete resolution of nighttime heartburn (or~     regurgitation), percentage of patients with relief or complete resolution of GERD-related~     sleep disturbance, the percentage of nights without nighttime heartburn (or regurgitation)~     over treatment period, change from baseline of the Pittsburgh Sleep Quality Index (PSQI)~     questionnaire total score, and change of the percentage of patients with relief of nighttime~     heartburn (or regurgitation) at post-treatment visit as compared to final visit in test group~     (Nexium plus Alginos). Safety endpoint is incidence of adverse events. The study hypothesis~     is that sodium alginate plus esomeprazole is superior to esomeprazole alone in relieving~     nighttime reflux symptoms and sleep disturbance in erosive GERD patients.~   "
98505|NCT02277873|"~     The purpose of this study is to establish the relationship between moon and births through~     two analytic models.~   "
98506|NCT02277860|"~     Physical activity and exercise have become an accepted and valued component of cystic~     fibrosis care. Regular physical activity and exercise can slow the rate of decline of~     pulmonary function, improve physical fitness, and enhance quality of life. However,~     motivating people to be more active is challenging. Supervised, facility-based exercise~     programs are expensive and labor intensive (since groups of patients with CF cannot exercise~     together in the same physical location). Home-based exercise using an interactive exergame~     device may be an effective way to improve adherence to an exercise program for patients with~     CF. Therefore, the primary objective of this study is to evaluate the effects of a 12-week,~     home-based exergame exercise intervention on aerobic capacity (peak VO2). The secondary~     endpoint is nasal potential difference, an indicator of how well sodium and chloride flow~     across the mucous membranes in the nose. Other outcomes include patient-reported quality of~     life and habitual physical activity level. Following baseline assessments participants will~     be begin a 12 week, partially-supervised exercise program consisting of at least 90 minutes~     per week of aerobic and resistance exercise training using the Nintendo Wii Fit Plus~     exergaming device. Participants will receive at least monthly follow-up phone calls to~     provide additional exercise counseling and motivation. After 12 weeks, they will continue~     with the exergame intervention for another 12 weeks, but without external supervision.~   "
98507|NCT02277847|"~     Study Design: Treatment, Randomized, Open Label, Parallel Assignment This study is an open~     randomized and controlled trial aiming at assessing the efficacy and safety of Idarubicin~     (IDA) at different doses of 8mg/m2 and 10mg/m2 combined with cytarabine as induction therapy~     for newly diagnosed Acute Myeloid Leukaemia (AML). All the recruited patients are allocated~     to group A ( 8mg/m2 group) or group B ( 10mg/m2) in random. It is advised that induction~     therapy should begain not late than 3 days after randomization. The regimens in detail can be~     refered in the therapy protocol.~   "
98508|NCT02277834|"~     Currently, X-rays and blood tests often miss pancreatic cancer. In this study, we are~     collecting and studying the fluid produced by the pancreas as a way to detect pancreatic~     cancer at an earlier stage.~   "
98509|NCT02277821|"~     The action of one Stendo pulsating suit session will be evaluated on 24 patients referred to~     the hypertension consultations for essential hypertension treated but not stabilized. The~     effect of one Stendo pulsating suit session system will be mainly assessed on the peripheral~     cutaneous microcirculation and on the central arterial pressure.~   "
98510|NCT02277808|"~     The reference nebulizer used for pentamidine nebulization is currently the Respirgard II ®,~     disposable pneumatic nebulizer. Other nebulizers are on the market and appear to have~     comparable properties and better availability to the hospital. Several studies remark that~     all nebulizers with comparable properties could be used for the nebulization.The aim of our~     work will be to evaluate and compare the pulmonary deposition between the reference nebulizer~     Respirgard II ®, and one of these nebulizers available on the market, the Isoneb ®. We will~     measure and compare these data's for each of the nebulizers via nebulization Amikacine and~     urinary dosage.~   "
98511|NCT02277795|"~     Male circumcision (MC) is an effective, research-tested, evidence-based HIV prevention~     strategy that is cost-saving. Randomized trials provide compelling evidence that MC reduces~     men's risk of heterosexually-acquired HIV-1 infection by about 60%. Early infant male~     circumcision (EIMC) confers the same benefits of MC in older ages for prevention of HIV and~     other sexually transmitted infections, and is less expensive and safer. To provide the~     evidence-based guidance for implementation of EIMC services, the investigators propose an~     implementation study to address several salient operations-research questions. Members of the~     research team have conducted a pilot study of the promising, but relatively new AccuCirc~     device for EIMC in Botswana and found it to be very safe. The AccuCirc device has the~     potential to simplify supply chain management in addition to eliminating the rare but serious~     potential complications associated with other EIMC devices. The investigators propose to~     enroll 600 infants in a safety and feasibility study of the AccuCirc device. Furthermore, it~     is imperative to identify, understand and overcome barriers to the adoption and integration~     of EIMC from the perspective of providers, about which virtually nothing is known. The~     investigators will explore, through qualitative methods, the perspective of providers with~     regard to offering and providing EIMC services. Equally important is having a thorough~     understanding of decision-making among parents with regard to opting for EIMC. The research~     team proposes to study this through collection of qualitative data among fathers and mothers.~     Lastly, the investigators will gather observational survey data from mothers in the catchment~     area and data from mothers who opted for EIMC will be compared with those from mothers who~     did not opt for EIMC to identify factors associated with uptake, including if, when, where~     and by whom EIMC services were offered. Among providers and parents the researchers will~     specifically explore what role, if any, the EIMC device plays in decision-making. The~     findings from this study will provide evidence necessary to refine implementation strategies~     for EIMC into public health and clinical practice settings and to assist the Kenyan Ministry~     of Health, other African governments and PEPFAR in the scale-up of EIMC service delivery for~     long-term HIV prevention.~   "
98512|NCT02277782|"~     The objective of this study is to evaluate the effect of intrathecal hydromorphone on the~     duration of labor analgesia and the incidence of epidural-associated temperature increase in~     laboring parturients. We hypothesize that intrathecal administration of longer-acting~     hydromorphone will:~        1. Prolong the duration and improve the quality of analgesia in labor, and~        2. Decrease the incidence of epidural-associated temperature increase in labor.~   "
98513|NCT02277769|"~     This is a randomized, double-blind, placebo-controlled, parallel-group study to confirm the~     efficacy and safety of Dupilumab monotherapy in adults with moderate-to-severe atopic~     dermatitis (AD).~   "
98514|NCT02277756|"~     Pain insensibility is often described in people with autism. The aim of this study is to test~     the pain perception in adults with autistic spectrum disorder without intellectual~     disability. An experimental model of pain is used to measure endogenous modulation systems.~     Thermic stimulations (tonic heat pain stimulation and cold-pressor test) are used to test~     excitatory and inhibitory pain mechanisms. Salivary cortisol and automatic nervous system~     (heart rate and blood pressure with an electrocardiogram (Brest :system dantec keypoint natus~     G3 ; Paris: nexfin HD®) are also tested and behavioral response to thermal stimulation~     assessed by an inspired behavior scale.~   "
98515|NCT02277743|"~     This is a randomized, double-blind, placebo-controlled, parallel group study to confirm the~     efficacy and safety of Dupilumab monotherapy in adults with moderate-to-severe atopic~     dermatitis (AD).~   "
98516|NCT02277730|"~     Hypotension occurs commonly during spinal anaesthesia for caesarean section with maternal and~     fetal adverse effects. The investigators developed a double-vasopressor automated system~     incorporating continuous non-invasive haemodynamic monitoring using NexfinTM with a two-step~     algorithm.~   "
98517|NCT02277717|"~     The purpose of this study is to evaluate the safety of a new medicinal drug SYD985 at~     different dose levels in patients with cancer, to understand how SYD985 is handled by the~     body and to evaluate the effect of SYD985 on the cancer.~   "
98518|NCT02277704|"~     This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose,~     parallel-group study that will investigate the efficacy and safety of two doses of TNX-102 SL~     —a sublingual formulation of cyclobenzaprine. Following successful screening and~     randomization, eligible subjects will return regularly to the study clinic for weekly or~     biweekly visits for assessments of efficacy and safety.~   "
98519|NCT02277691|"~     The purpose of this study is to evaluate the safety of long-term administration of TAK-536,~     amlodipine (AML), and hydrochlorothiazide (HCTZ) in participants with essential hypertension.~   "
98520|NCT02277678|"~     The primary objectives of this study are to compare the efficacy of pain relief between~     epidural oxycodone and epidural morphine for postoperative analgesia after elective caesarean~     section and to compare the incidence and severity of pruritus. Secondary objectives are to~     compare other side effects of epidural administered oxycodone and morphine (nausea and~     vomiting, sedation, respiratory depression) and to investigate the safety and efficacy of~     epidural oxycodone and epidural morphine after use for postoperative analgesia in caesarean~     sections.~   "
98521|NCT02277665|"~     Approximately 50% of persons seeking treatment for cannabis-use disorders (CUDs) regularly~     smoke tobacco. Combining tobacco with cannabis has become a common method of smoking~     cannabis. Similarities of use, and using together, can make quitting difficult. Stopping~     tobacco simultaneously with cannabis may be beneficial. Little scientific information~     currently addresses how to best target tobacco smoking during treatment for CUDs. Our~     long-term goal is to develop an effective protocol for intervening in tobacco smoking without~     changing cannabis outcomes.~      This protocol reflects the planned Stage 1, proof-of-concept study that will compare a~     combined cannabis and tobacco intervention to one that targets CUD only. Hypotheses assert~     that the intervention (1) will be accepted by the majority of eligible participants (2) will~     result in more tobacco quit attempts and rates than the CUD-only treatment; and (3) will not~     adversely affect cannabis outcomes. Last, the project will evaluate the potential of specific~     moderators of outcomes to predict outcomes and inform subsequent treatment development~     efforts. If the hypotheses were confirmed, dissemination of this protocol would reduce~     adverse psychosocial and health consequences of tobacco or cannabis dependence. Findings will~     inform future development of prevention and intervention strategies.~   "
98522|NCT02277652|"~     The purpose of this study was to compare the four different intubation devices in 6 different~     scenarios.~   "
98523|NCT02277639|"~     This is a Phase II trial to determine the ability of a reduced intensity conditioning regimen~     to allow successful engraftment with CD3+ /CD19+ depleted peripheral stem cell grafts from~     mismatched donors. There are two conditioning regimens depending upon patient diagnosis and~     age.~   "
98524|NCT02277626|"~     It is the goal of the proposed study to compare the efficacy, as assessed primarily by sputum~     weight, of these two different devices (the Electroflo 500 and VEST therapy) for airway~     clearance (AC) in CF patients with mild to moderate lung disease, who have stable lung health~     and perform AC at home as part of their routine therapeutic regimen.~   "
98525|NCT02277613|"~     This is a double-blind, sham-controlled clinical study to evaluate the safety and feasibility~     of AMI MultiStem therapy in subjects who have had a heart attack (Non-ST elevation MI).~   "
98526|NCT02277600|"~     This is an open-label, single sequence, 2-cohort, drug-drug interaction study in healthy male~     and female subjects. There is no formal hypothesis, however, it is expected that the~     coadministration of BMS-663068 with darunavir (DRV)/cobicistat (COBI) or COBI will increase~     the systemic exposure of BMS-626529.~   "
98527|NCT02277587|"~     This is a randomized, controlled, open, three-armed, multi-centre study designed to compare~     the effects of dual-release hydrocortisone preparations versus conventional glucocorticoid~     therapy on anthropometric parameters, metabolic syndrome, infectious, immunological profile,~     cardiovascular system, bone mass and quality of life in patients affected by primary or~     secondary adrenal insufficiency.~   "
98528|NCT02277574|"~     This is a Phase 1b, randomized, multi-dose, placebo-controlled, dose-escalation, multi-center~     study of AMP-110 in adult subjects with rheumatoid arthritis.~   "
98529|NCT02277561|"~     This pilot clinical trial studies how well voxel based diffusion tensor imaging in predicting~     response in patients with brain metastases undergoing whole-brain radiation therapy or~     stereotactic radiosurgery. Voxel based diffusion tensor imaging (VB-DTI) may allow doctors to~     measure response to whole brain radiation therapy or stereotactic radiosurgery earlier than~     is possible with a standard magnetic resonance imaging. The earlier ability to measure~     response may allow for consideration of alternative therapies at an earlier stage.~   "
98530|NCT02277548|"~     To assess the efficacy of pregabalin in the management of mucositis pain in patients~     receiving radiotherapy to the head and neck. Eligible study subjects will be enrolled among~     those being treated for oropharyngeal cancer with definitive chemotherapy and radiation~     therapy (photons) to the head and neck in the Department of Radiation Oncology at the~     University of Pennsylvania.~   "
98533|NCT02277509|"~     This study is being conducted in two phases. The first phase was a pilot implementation of~     the study protocol, which provided preliminary data from seeking funding for a larger scale~     trial. The study focused on testing the effects of a Diabetes Prevention Program (DPP) that~     has been adapted culturally and linguistically to address diabetes prevention among Chinese~     immigrants. Study implementation involves a variety capacity building community partnership~     initiatives. Partnering organizations within New York City (NYC) have included the Chinese~     Community Partnership for Health (CCPH) of New York Presbyterian Hospital of Lower Manhattan~     Hospital, the Chinese American Independent Practice Association (CAIPA), the Diabetes~     Research and Training Center of Albert Einstein College of Medicine (Einstein), and the City~     University of New York (CUNY) School of Public Health. More recently, our collaboration has~     expanded the potential for wider dissemination in collaboration with the Pace University~     Confucius Center of the Confucius Institute. By supporting Chinese language and cultural~     programs, the Confucius Institute facilitates communication with the 2 billion native Chinese~     speakers as migration and trade increase interactions globally.~   "
98534|NCT02277496|"~     The project is designed to evaluate a participatory implementation model in HealthCorps (HC)~     high schools and to assess outcomes within and across school settings . The behavioral~     objectives from the 2010 Dietary Guidelines to address obesity in youth include: 1)~     decreasing sugary beverage intake; 2) increasing frequency of breakfast; 3) increasing~     vegetable and fruit intake to 2½ cups per day;4) decreasing frequency of fast food meals;5)~     becoming physically active (goal of 1 hour per day); and 6) reducing sedentary behavior time~     (<2 hour day). The study is employing system dynamics modeling (SDM) to assess wellness~     programming options and to evaluate the program implementation within the context of diverse~     school ecologies. The RE-AIM evaluation metric (Reach, Effectiveness, Adoption,~     Implementation, and Maintenance) is used to guide SDM development and validation.~      The Specific Aims are:~        1. To use PAR (Participatory Action Research) methods to refine the school wellness program~          model and toolkit components that address institutional/community level program~          implementation barriers and individual level barriers to achieving healthy lifestyle~          recommendations.~        2. To assess the effectiveness of program components using process evaluation techniques~          guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance)~          model.~        3. To evaluate implementation with system dynamics modeling to facilitate dissemination.~          The simulation analysis will apply the RE-AIM framework to address: Reach (participation~          rates), effectiveness (outcomes), adoption (acceptability), implementation (intervention~          fidelity), and maintenance (sustainability of lifestyle changes by students and programs~          by schools), in order to facilitate refining the toolkits and training program for~          dissemination to other school setting and diverse educational venues.~   "
98535|NCT02277483|"~     Evaluation of the efficacy and safety of SLIT with LAIS® Mites Sublingual tablets compared to~     standard drug treatment in patients aged over 60 years suffering from house dust mite (HDM)~     induced allergic rhino-conjunctivitis with/without asthma.~   "
98536|NCT02277470|"~     The purpose of this study is to gain insights in the pharmacokinetics of golimumab in~     moderate to severe Ulcerative Colitis after subcutaneous administration, during induction and~     maintenance treatment the investigators will collect blood and stool samples at different~     time points.~   "
98537|NCT02277457|"~     Hypotheses:~      Short-term - Targeted therapy with erlotinib or crizotinib plus PART (Personalized Adaptive~     Radiation Therapy) will be safe and will yield favorable outcomes in patients with stage III,~     EGFR (Epidermal Growth Factor Receptor) + or ALK (Anaplastic Lymphoma Kinase) + NSCLC~     (Non-Small Cell Lung Cancer).~      Long-term - In patients with stage III NSCLC harboring driver mutations, treatment with~     relevant targeted agents plus PART will improve both local-regional and systemic tumor~     control resulting in improved survival relative to standard chemoradiotherapy.~   "
98538|NCT02277444|"~     The purpose of this study is to evaluate the pharmacokinetics (the study of the way a drug~     enters and leaves the blood and tissues over time) of golimumab administered intravenously~     (IV) to pediatric participants with polyarticular (affects 5 or more joints) juvenile (an~     onset before age 16) idiopathic (of unknown cause) arthritis (joint pain) (pJIA) manifested~     by greater than or equal to (>=) 5 joints with active arthritis despite methotrexate (MTX)~     therapy for >= 2 months.~   "
98539|NCT02277431|"~     Participants experiencing recurrent gastrointestinal symptoms in this double-blind,~     randomized, controlled trial will receive either a commercially-available probiotic dietary~     supplement or placebo. The investigators hypothesize that participants in the probiotic~     dietary supplement group will experience greater improvement in their gastrointestinal~     symptoms than participants in the placebo group.~   "
98540|NCT02277418|"~     The purpose of this study was to compare the Venner a.p. advance video laryngoscope to Miller~     laryngoscope during resuscitation with and without chest compressions.~   "
98541|NCT02277405|"~     The aim of the study was to compare time and success rates of four intubation devices in a~     cardiopulmonary scenario with and without chest compressions with a standardized pediatric~     manikin model.~   "
98542|NCT02277392|"~     This is a phase-I, dose escalation study to assess the safety and biological activity of~     cyclophosphamide/fludarabine lymphodepletion followed by adoptive transfer of vaccine-primed,~     ex vivo CD3/CD28-costimulated peripheral blood autologous T-cells, and recombinant human~     interleukin-18 (SB-485232, IL-18) treatment in adult patients with recurrent, Stage III or IV~     ovarian cancer, fallopian tube or primary peritoneal cancer who previously underwent~     induction vaccination with whole tumor vaccine~   "
98543|NCT02277379|"~     Excessive bleeding after cardiopulmonary bypass (CPB) operations remains to be a persistent~     problem. Antiplatelet therapy (APT) is an integral component of perioperative management in~     patients undergoing cardiac surgery. The impact of drug induced platelet inhibition on early~     postoperative bleeding extent and transfusion requirements remains difficult to predict.~      In addition to, resistance to antiplatelet drugs as well as perioperative increase in~     platelet reactivity following CPB has been reported but this phenomenon has to be~     comprehensively investigated.~      The best point-of-care platelet function test to predict bleeding complications/transfusion~     requirements remains unclear. In addition to, the best test platelet function test to monitor~     resistance to antiplatelet therapy and its impact on clinical outcomes remains elusive.~      The aim of this study is:~        1. to compare two point-of-care platelet function analyzers (Multiplate and ROTEM Platelet)~          in regard to prediction of bleeding complications/trasfusion requirements.~        2. to compare two point-of-care platelet function analyzers (Multiplate and ROTEM Platelet)~          in regard to detection of high on-treatment platelet reactivity both pre- and~          postoperatively.~   "
98544|NCT02277366|"~     The purpose of this study is to determine the diagnostic yield of early lung cancer in high~     risk population, who smokes or has other risk factors, by different bronchoscopy,.~     Furthermore, another purpose is to determine whether the different bronchoscopy are~     significant different in diagnosing early lung cancer.~   "
98545|NCT02277353|"~     NICOM® is a recently developed noninvasive cardiac output monitoring device, and indices~     derived from NICOM® such as SVV has been reported to predict fluid responsiveness in the~     previous studies. However, its usefulness in prone positioning has not been investigated.~     Thus, the aim of this prospective observational study is to evaluate the usefulness of stroke~     volume variation (SVV) derived from NICOM® to predict fluid responsiveness in prone patients~     undergoing spine surgery.~   "
98546|NCT02277340|"~     This study presents 23 sacrococcygeal pilonidal disease cases treated with endoscopic~     cleaning and fulguration of pilonidal sinus inner surfaca followed by application of~     crystallized phenol into the sinus.~   "
98547|NCT02277327|"~     The investigators hypothesize that an intervention, within an established patient-centered~     medical home, aimed at reducing modifiable risks for hospitalization, can decrease hospital~     utilization among medically complex children.~   "
98548|NCT02277314|"~     The overall objective is to determine the visual outcomes and cost to perform Manual Small~     Incision Cataract Surgery (MSICS) in a small cohort at an academic medical center in the~     United States. The primary outcome measure will be the percentage of the study group~     achieving a post operative visual acuity 20/40 Snellen. This percentage will be compared to~     historical cohorts reported for phacoemulsification cataract surgery (PCS), when performed in~     academic centers. A secondary outcome will be to determine the actual institutional cost of~     providing MSICS in the setting of an academic medical center. The hypothesis is that MSICS is~     appropriate for a teaching environment (as evidenced by a comparable rate of 20/40 acuity or~     better at 90 days post op, as compared to PCS), and can be provided at a cost that makes~     visual rehabilitation affordable to the uninsured and underinsured.~   "
98549|NCT02277301|"~     This is a mixed-methods study centred on a prospective randomised openlabel blinded endpoint~     (PROBE) pilot clinical trial with a waitinglist control group. The study will be conducted in~     three areas of Northern Ireland: Lisburn, North Down & Ards, and Downpatrick. At least 50~     women with infants under 13 months old will be recruited during August/September 2014.~   "
98550|NCT02277288|"~     The purpose of this randomized control trial study is to determine if intraoperative bladder~     instillation of fluid decreases the time to discharge after having an outpatient mid-urethral~     sling procedure, and to measure the cost savings of this decrease in hospital stay. Charges~     will be broken down between recovery room charges and discharge area, as recovery room~     charges are significantly higher. The investigators suspect that a shorter time in the~     recovery room will translate into fewer charges.~   "
98551|NCT02277275|"~     High-protein diets better preserve lean mass than conventional low-fat diets. However, they~     are costly and have potential health risks. Preserving lean mass is important for sustaining~     high resting energy expenditure, leading to greater initial weight loss, better weight~     maintenance and improving blood sugar levels. Branched-chain amino acids (BCAA) supplements~     are known to preserve lean mass but their effects during weight loss have not been examined.~     Investigators want to investigate if a BCAA-supplemented diet is more effective than a~     standard hypocaloric diet in terms of the aforementioned benefits, and yet has less~     detrimental effects than a high-protein diet for weight loss. Using a 16-week weight loss and~     8-week weight maintenance intervention, overweight and obese men and women will be randomized~     to either a hypocaloric diet with BCAA or placebo supplements or a high-protein diet with~     placebo supplements. Participants' compliance to the diet versus supplements will be~     compared. Body composition, resting and diet-induced energy expenditure, insulin sensitivity~     will be measured and blood samples taken before and after weight loss. These findings will~     inform on the benefits of BCAA-supplementation during energy restriction and may offer an~     alternative cost-effective strategy for weight loss and maintenance, without the adverse~     health effects of a high-protein load.~   "
98552|NCT02277262|"~     To evaluate the efficacy of the use of swine dermal collagen prosthesis implanted~     preperitoneally as a prophylactic procedure against incisional hernia in patients operated in~     urgency/emergency setting in contaminated/infected fields with peritonitis. The aim of the~     study is to reduce the incidence of incisional hernia from 50% to 20%.~   "
98553|NCT02277249|"~     Current practice for the provision of late second trimester abortion (dilation and~     evacuation, or D&E) often involves the administration of digoxin into the fetal compartment~     to induce fetal demise prior to the procedure. Digoxin may be administered transabdominally~     or transvaginally into the fetal compartment. Both modes of administration have been shown in~     prospective studies to be highly effective and safe. Both modes of administration are~     considered standard of care. This pilot study will directly compare transabdominal and~     transvaginal digoxin with respect to patient preference (i.e, patient pain score describing~     discomfort with injection).~   "
98554|NCT02277236|"~     This pilot study will aid the development of a sonographic screening method used to obtain~     proxy measures of LBM and estimates of muscle composition that relate to Intramuscular~     adipose tissue (IMAT), lipid metabolism, and insulin resistance. Typically, age-related~     muscle loss is not assessed in older adults until they began to show signs of trouble~     managing their own lives independently. In addition to the loss of independence that is~     typically seen with diminished muscle mass and function (sarcopenia), age-related changes in~     lean body mass can have negative effects on insulin sensitivity. The investigators central~     hypothesis is that the muscle characteristics derived from ultrasound (US) will be~     significantly associated with estimates of dual energy X-ray absorptiometry (DXA) LBM, CT~     scan measures of IMAT, estimates of insulin homeostasis, and serum levels of inflammatory~     cytokines.~   "
98561|NCT02277145|"~     Radiation therapy is one of the main means for treating malignant tumor, during which~     radioactive lung injury is inevitable. Currently there is nearly no effective clinical~     treatment for late post-radiotherapy pulmonary fibrosis. This study intends to carry out an~     open, single-center, non-randomized phase I clinical trial. During the treatment, the local~     lesions will be fully lavaged, and then clinical grade umbilical cord mesenchymal stem cells~     (MSCs) will be injected directly into the lesion by fiberoptic bronchoscopy. After six-month~     observation, the investigators will initially evaluate the safety and effectiveness of the~     treatment by measuring two key indicators-the CT density histogram and the patients'~     self-evaluation, and one secondary indicator—the changes of TGF-β1 contents, both before and~     after the treatment. Meanwhile, the investigators will make a preliminary discuss about the~     possible immunomodulatory effects of the umbilical cord MSCs.~   "
98555|NCT02277223|"~     Background: Curcumin in an active phytochemical substance, used as part of the human diet,~     that has anti-inflammatory and anti-oxidative properties which were demonstrated in multiple~     experimental models of colitis including a positive effect on maintenance of remission in~     adult ulcerative colitis (UC) patients. Objectives: To examine the effect of curcumin as~     complementary medication in induction and maintenance therapy in pediatric patients with mild~     to moderate ulcerative colitis. Design: A prospective, randomized, placebo-controlled study.~     Setting: Pediatric gastroenterology centers. Participants: Children 6 year to 18 years who~     are diagnosed with mild to moderate UC and are planned to receive either 5-ASA or~     corticosteroids induction treatment. Main outcome measures: Disease activity defined by the~     Pediatric Ulcerative Colitis Activity Index (PUCAI) at 2 weeks and 6 months. Secondary~     outcome measures: Effect of curcumin treatment on serum inflammatory markers, calprotectin~     and fecal microbiota. Data analysis: Data will be collected and analyzed using SPSS (version~     21.0, SPSS, Inc., Chicago, IL, USA). Fisher's exact test will be used to explore univariate~     associations between primary outcomes and categorical variables. Associations of continues~     variables with primary outcome measures will be examined using ANOVA with repeated measures.~     P-values <0.05 will be considered significant.~   "
98556|NCT02277210|"~     Oocyte aspiration under the guidance of transvaginal ultrasound is an integral part in IVF~     treatment. Follicular flushing has been advocated. However, subsequent data from randomized~     trials failed to demonstrate any benefits with routine follicular flushing in normally~     responding patients. Instead, it has been shown to prolong the operating time, increase the~     procedure-related pain and analgesics requirement. Most of the IVF centers no longer perform~     routine follicular flushing in normally responding patients.~      The potential role of follicular flushing in patients with a limited number of developing~     follicles is conflicting based on the recently published randomized trials. The aim of the~     present study is to determine the effect of follicular flushing on the ongoing pregnancy rate~     in patients who developed four or fewer follicles of 14mm following standard ovarian~     stimulation for IVF.~   "
98557|NCT02277197|"~     The epidermal growth factor receptor (EGFR) is both oncogene and prognostic biomarker in head~     and neck squamous cell carcinoma (HNSCC). EGFR's functional importance in HNSCC resulted in~     development of the first molecularly targeted strategy, the anti-EGFR monoclonal antibody~     cetuximab. Given the lack of therapeutic options for patients with recurrent/metastatic HNSCC~     after failure of cetuximab, there is strong scientific interest in understanding resistance~     in order to identify new therapies for this population. A possible resistance mechanism to~     anti-EGFR therapy in HNSCC is primary or compensatory activation of alternate growth factor~     receptors including c-Met. The MET oncogene encodes c-Met, an RTK bound exclusively by the~     ligand, hepatocyte growth factor (HGF). The HGF/c-Met signaling pathway converges with the~     EGFR network at both the PI3K/Akt and MAPK nodes. Laboratory data suggest the ability for~     reciprocal compensation between EGFR and c-Met. We hypothesize that HGF/c-Met pathway~     inhibition may overcome resistance to cetuximab in patients with HNSCC, such as those with~     clinical cetuximab resistance.~      Ficlatuzumab (AV-299) is a humanized HGF-inhibitory immunoglobulin G1 (IgG1) monoclonal~     antibody. The primary objective of this phase 1b study is to find the recommended phase II~     dose (RP2D) of the combination of ficlatuzumab and cetuximab in patients with~     recurrent/metastaticHNSCC. The dose-finding study design will follow a Narayana k-in-a-row~     design with k set to 2 to target a 33% rate of dose-limiting toxicity (DLT). In the~     dose-finding phase, a total of 8 patients will be treated if no DLTs are observed or 14~     patients if at least one DLT occurs. An expansion cohort will then proceed at RP2D until 12~     patients have been treated at that dose level with the combination of ficlatuzumab and~     cetuximab. We will evaluate biomarkers of HGF/cMet pathway activation in baseline tissue,~     plasma and immune cells for a preliminary relationship with clinical activity.~   "
98558|NCT02277184|"~     Head and neck squamous cell carcinoma (HNSCC) is the most common cancer arising in the upper~     aerodigestive tract, and is the sixth leading incident cancer worldwide. Despite advances in~     multimodality therapy, 5-year overall survival (OS) is 40-60%, and has increased only~     incrementally in the past two decades. The current standard of care for primary nonsurgical~     management of locally advanced HNSCC is concurrent cisplatin-radiotheray, which significantly~     improved OS, progression-free survival, and locoregional control compared with radiotherapy~     alone in the landmark Intergroup trial 0126.~      The MET proto-oncogene encodes c-Met, a heterodimeric growth factor receptor bound~     exclusively by its ligand, hepatocyte growth factor (HGF). In the laboratory, activation of~     the HGF/c-Met pathway is associated with resistance to cisplatin and radiotherapy in HNSCC.~     We hypothesize that the addition of an HGF/c-Met pathway inhibitor to cisplatin-radiotherapy~     may improve outcomes in HNSCC. Ficlatuzumab (AV-299) is a humanized HGF-inhibitory IgG1~     monoclonal antibody.~      The primary objective of this study is to establish the recommended phase II dose (RP2D) of~     the combination of ficlatuzumab, cisplatin and intensity-modulated radiotherapy (IMRT), in~     patients with locally advanced HNSCC. The dose-finding study design will follow a Narayana~     k-in-a-row design with k set to 3 to target a 33% DLT rate. In the dose-finding phase, a~     total of either 10 or 14 patients will be treated. If no DLTs are observed among 10 patients,~     the highest dose tier will be declared the RP2D. Otherwise the RP2D will be estimated from~     DLTs across all dose levels by isotonic regression. The secondary objective is to estimate~     biomarker association with preliminary clinical response. We will evaluate biomarkers of~     HGF/cMet pathway activation in tumor tissue, plasma, and immune cells.~   "
98559|NCT02277171|"~     According to the World Health Organization, hundreds of millions of patients are affected by~     health-care associated infections worldwide each year, resulting in prolonged hospital stays,~     long-term disabilities, deaths, and financial losses for health systems. The most common~     hospital-acquired infection is Urinary Tract Infection (UTI), accounting for almost 40% of~     all nosocomial infections. Most hospital-acquired UTIs are associated with catheterization.~     In fact, urinary catheter-related bacteriuria is the most common health care associated~     infection worldwide. Catheter-associated UTI (CAUTI) develops following adhesion of~     planktonic bacteria to the surface of the catheter and colonization, creating a persistent~     environment called a biofilm. The nature of biofilm structure together with the physiological~     attributes of biofilm organisms confers an inherent resistance to various antimicrobial~     agents such as antibiotics, disinfectants or germicides, augmenting the potential of these~     pathogens to cause infections in catheterized patients.~      Nitric oxide (NO) is a naturally-produced gas molecule with broad-spectrum antimicrobial~     activity. NO is used in the clinics to treat pulmonary hypertension in neonates and adults.~     Studies have shown that low-dose NO is associated with prevention of biofilm formation,~     biofilm dispersal and elimination of bacteria. It is suggested that NO prevents bacteria~     attachment to catheter surfaces and inhibits biofilm formation in a mechanism involving~     reduction and modification of proteins that mediate cell-substrate and cell-cell~     interactions.~      The investigators team, using a proprietary technology impregnate urinary catheters with NO~     (i.e. NO-impregnated catheters). These catheters release low concentration of NO following~     exposure to urine over a 14-day period. In vitro studies showed that NO-impregnated catheters~     prevent bacterial colonization and biofilm formation of Escherichia coli on exterior and~     luminal surfaces of the catheters. In addition, NO released from these catheters is able to~     eradicate up to 4log colony forming unit/ml of bacteria within the surrounding media.~     Moreover, NO-impregnated catheters exhibit superior performance compared to silver-coated~     catheters, and similar anti-infective properties compared to antibiotic-coated catheters.~      Primary objectives: To assess the safety and tolerability of NO-impregnated catheters in~     patients older than 18 years old undergoing radical prostatectomy and catheterized for 7-14~     days.~   "
98560|NCT02277158|"~     The purpose of this study is to determine the maximum tolerated dose and safety of S-1 plus~     radiotherapy for patients with rectal cancer~   "
98621|NCT02276365|"~     The objective of the study was to investigate whether there is a drug-drug interaction~     between BI 10773 and pioglitazone when co-administered as multiple oral doses. Therefore, the~     relative bioavailabilities of BI 10773 and pioglitazone were determined when both drugs were~     given in combination compared with BI 10773 and pioglitazone given alone.~   "
98562|NCT02277132|"~     Rationale: Severe, early-onset fetal growth restriction (FGR) due to placental insufficiency~     is associated with a high risk of perinatal morbidity with long-lasting sequelae and~     mortality. Placental insufficiency is the result of abnormal formation and function of the~     placenta (placentation) with inadequate remodelling of the maternal spiral (uteroplacental)~     arteries. There is currently no therapy available with demonstrated effectiveness. Evidence~     suggests Sildenafil citrate improves uteroplacental blood flow, growth, and meaningful~     outcomes.~      Objective: To evaluate the effectiveness of sildenafil (versus placebo) in achieving healthy~     perinatal survival.~      Study design: Multicenter nationwide randomized placebo-controlled clinical trial.~      Study population: Women with a singleton pregnancy between 20 and 30 weeks with severe fetal~     growth restriction of likely placental origin, and with estimated significant likelihood of~     perinatal death.~      Intervention: Sildenafil 25mg or placebo tablet orally three times daily. Main study~     parameters/endpoints: Perinatal healthy survival, i.e. survival without severe neonatal~     morbidity at term age.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: Taking tablets three times daily. No additional ultrasounds, other than standard~     clinical protocol, one extra blood sample at inclusion. No risks anticipated, unexpected~     medication-associated risks can't be excluded on beforehand.~   "
98563|NCT02277119|"~     Assess the repeatability and agreement of the Optic Disc Parameters, Retinal Nerve Fiber~     Layer (RNFL) Thickness, and Full Retinal Thickness between the Maestro and iVue OCT devices~   "
98564|NCT02277106|"~     Stage 1 is a double-blind, proof-of-concept study designed to evaluate the safety,~     tolerability, PK, and efficacy of SAGE-547 Injection in male and female patients with~     essential tremor in the upper limb.~      Stage 2 is an open-label arm designed to evaluate the safety, tolerability, PK, and~     effeciveness of SAGE-547 Injection at a higher dose than in Stage 1. Subjects who completed~     Stage 1 will be invited to participate in Stage 2.~   "
98565|NCT02277093|"~     The investigators propose to assess the efficacy, progression-free survival, and adverse~     events of pacritinib in patients with refractory colorectal cancer.~   "
98566|NCT02277080|"~     The primary aim is to investigate the dose and time dependent effects of different opioids on~     the immune and endocrine systems.~      The secondary aim is to investigate whether associations between the function of the immune~     and endocrine systems and opioid use influence cognitive function, pain and quality of life.~   "
98567|NCT02277067|"~     We will compare between Carbitocin and Misoprostol in prevention of postpartum hemorrhage in~     high risk patients after C.S.~   "
98568|NCT02277054|"~     In this study the safety and effectiveness of biosynthetic cornea, comprising~     interpenetrating networks of recombinant human collagen and phosphorylcholine, will be tested~     in patients with severe corneal pathology (corneal ulcers or corneal opacification from~     corneal injury, burn or infection) - diseases, where human donor cornea transplantation (the~     only widely accepted treatment) carries a high risk of rejection.~   "
98569|NCT02277041|"~     We will compare efficacy and safety of Carbetocin with Misoprostol in prevention of~     postpartum hemorrhage in Placenta previa women after C.S.~   "
98570|NCT02277028|"~     This study will compare bilateral priming followed by task specific training to health care~     education followed by the same task specific training protocol. The intention is to~     understand the effects of priming on upper limb training post-stroke.~   "
98571|NCT02277015|"~     The European Resuscitation Council (ERC) 2010 cardiopulmonary resuscitation (CPR) guidelines~     suggest that intubators should be able to secure the airway without interrupting chest~     compression. We examine the performance of the Berci-Kaplan DCI (BERCI), the GlideScope~     (GVL), the AirTraq, the Pentax AWS (Pentax) and the Miller laryngoscope (MIL) for~     endotracheal intubation (ETI) during pediatric resuscitation with and without chest~     compressions.~   "
98572|NCT02277002|"~     Traffic related air pollution is a well-recognised and much studied contributor to smog and~     is linked to a number of adverse health outcomes. Although traffic pollutants can travel long~     distances, exposure to the highest levels of the raw emissions can occur closest to the~     source; e.g. in a car in dense traffic conditions. Time spent in-vehicle may contribute up to~     half of commuters' daily exposure to certain air pollutants. Most new cars now have or allow~     for a cabin air filter, but it is not known how well cabin air filtration can reduce exposure~     to traffic-related air pollution.~      This intervention study will measure commuters' exposure to air pollutants in rush hour~     traffic. It will evaluate the impact of this exposure on stress hormones in saliva, and short~     term cardiopulmonary health indicators such as blood pressure, heart rate variability and~     respiratory inflammation. It will also look at effects on cognition (mental processing and~     judgement) in this real world environment where any deficit could be important to safety. In~     addition, the study will examine whether cabin air filtration can reduce the exposure to~     traffic related air pollutants and result in improvements in short term cardiopulmonary and~     cognitive function. This research will contribute to our understanding of how this~     environment contributes to Canadians' overall air pollution exposure as well as the potential~     health impacts. It will also test a potentially valuable and economical means of reducing~     exposure to traffic related air pollution in a commuting environment. The study may also~     guide the future implementation of the use of cabin filters as an exposure reduction~     intervention.~      Overall Project Objectives:~      Can cabin air filtration effectively reduce exposure to traffic related air pollution? Does~     commuter exposure to air pollution affect short term stress, and cardiopulmonary and~     cognitive function? Can cabin air filtration mitigate the health effects of commuters'~     exposure to air pollution?~   "
98573|NCT02276989|"~     In a small, well-characterized sample of prescription opioid abusers (POAs) with chronic pain~     and on buprenorphine therapy, this study will investigate the utility and feasibility of two~     novel tracer compounds, and in combination with a standard marker (riboflavin), to monitor~     adherence to study drug prescription in the parent clinical trial.~   "
98574|NCT02276976|"~     The purpose of this study is:1)to observe topological organization in brain structural and~     functional networks in cerebral white matter lesion patients and to evaluate the association~     between impairment of cognitive function and cerebral structural and functional networks in~     those patients;2)to indicate the role of genetic factors in the occurrence and prognosis of~     cerebral white matter lesions~   "
98593|NCT02276729|"~     Individuals who have sustained a stroke are often left with residual deficits of the upper~     limb such as impaired movement and sensation. These deficits restrict functional use of the~     limb in everyday activities and can result in increased dependency upon others to engage in~     some tasks. Regaining independence through functional use of the arm and hand is an aim of~     occupational therapy rehabilitation. Mirror box therapy (MBT) is a relatively new innovation~     being introduced into occupational therapy interventions. Some studies have reported it to be~     beneficial in upper limb rehabilitation, however, these studies have not involved a sub-acute~     stroke population. This pilot study aims to provide robust evidence, using RCT design, as to~     whether this type of therapy may offer greater potential in functional gains in the sub-acute~     recovery period of stroke than standard rehabilitation of the upper limb alone.~   "
98575|NCT02276963|"~     Ublituximab (also known as LFB-R603) is a monoclonal antibody that specifically binds to the~     trans-membrane antigen CD20. The binding induces immune response that causes lysis of B~     cells.~      The rationale for using ublituximab in neuromyelitis optica (NMO) and neuromyelitis optica~     spectrum disorder (NMOSD) is based on the known roles of B cells, antibody production and~     plasma cells in the pathophysiology of NMO. NMO is characterized by the presence of an~     anti-Aquaporin-4 (AQP4) antibody, which can only be produced by differentiation of B cells to~     plasma cells. Because these anti-AQP4 antibodies may be pathogenic, B cells recognizing AQP4~     may be directly involved in the disease process as well. B cells also play a role as potent~     antigen presenting cells in NMO. The strongest evidence of the importance of B cells in NMO~     comes from studies of B cell depletion, most commonly with anti-CD20 monoclonal antibody,~     rituximab (Rituxan®).~      Rituximab has been shown in five retrospective and two prospective studies to be effective in~     reducing NMO relapses up to 90% and achieving remission in up to 80% of patients solely by~     its action on CD20+ B cells, despite no change in plasma cell population and anti-AQP4~     antibody titers. These human trials strongly suggest a critical role for B cells in the~     pathophysiology of human disease. While typically used in the prevention of disease, B-cell~     depletion may be beneficial in the treatment of an acute relapse as well. Emerging evidence~     indicates that peripheral B cells are activated during a relapse and plasmablast production~     of anti-AQP4 antibodies spikes. B cells are also found within acute lesions of the spinal~     cord and optic nerve suggesting roles both in the blood and in the central nervous system~     during a relapse.~   "
98576|NCT02276950|"~     The overall project aim is to study risk and outcomes following cardiac surgery by~     cross-linking high-quality national Swedish health-data registers for population-based~     investigations of individual level clinically relevant patient data.~   "
98577|NCT02276937|"~     DVC1-0101 is a gene therapy medicine to treat peripheral arterial disease (PAD) based on~     recombinant F-gene-deleted, non-transmissible Sendai virus (rSeV/dF) expressing human~     fibroblast growth factor-2 (FGF-2) gene. The previous Phase I/IIa study demonstrated no~     serious adverse event related to the administration, and suggested possible improvement of~     local blood flow and walking performance of PAD patients.~      The primary objective of the current Phase IIb study is to investigate the clinical efficacy~     of DVC1-0101 (1x10^9 ciu/leg, 5x10^9 ciu/leg) in patients with IC. We also aim to examine the~     dose-response relationship using the rate of improvement in walking function as an indicator.~   "
98578|NCT02276924|"~     Upper Urinary Tract Tumors have an incidence of 1 to 2 cases for 100 000 persons per year.~     The standard treatment for these tumors is the ablation of the kidney, ureter and a part of~     the bladder surrounding the ureteral orifice. The development of new diagnosis and treatment~     techniques through natural routes opens the possibility to use conservative treatments. The~     investigators hypothesis is that during a reno-ureteroscopy, laser confocal microscopy will~     allow the discrimination between normal and pathologic urothelium by microscopic analysis.~     This will prevent the systematic use of biopsies which are often difficult and iatrogenic.~   "
98579|NCT02276911|"~     A prospective, randomized, placebo controlled, double-blinded study at a single institution.~   "
98580|NCT02276898|"~     The Lung Clearance Index (LCI) is a non invasive measure of lung function that is more~     sensitive than FEV1. It can be used to measure lung function in children younger than 6 years~     of age. Therefore, it has a future role in assessing novel therapeutics in the Cystic~     Fibrosis (CF) population. As such, determining if it can be used as a short term~     pharmacodynamic biomarker is paramount.~   "
98581|NCT02276885|"~     The purpose of this study is to test whether a radiotherapy regimen of 8 GY x 3 days over 5~     days (every other day) is as safe (well-tolerated) and effective as 6 Gy x 5 over five~     consecutive days~   "
98582|NCT02276872|"~     This is a multi-center, open-label, safety, tolerability and pharmacokinetic study of oral~     treprostinil in pediatric subjects with stable PAH aged 7 to 17 years who are, (1)~     transitioning from parenteral Remodulin therapy; (2) transitioning from inhaled prostacyclin~     therapy; or (3) not currently receiving prostacyclin therapy.~   "
98583|NCT02276859|"~     Patients receive a standardized high-protein test meal at breakfast time. Insulin is given as~     bolus (normal or dual-wave (normal plus square) and basal rate using an insulin pump. The 3h~     post-meal glucose excursions will be recorded by self-blood glucose measurements (SMBG)~     (every 1 hour) and continuous glucose monitoring system (CGMS). The intervention is taking~     part under in-patient clinical conditions.~   "
98584|NCT02276846|"~     The aim of the study is to use optical coherence tomography (OCT) to investigate the efficacy~     of Paclitaxel-eluting PTCA-balloon dilation (SeQuent Please) in SB and drug eluting stent~     (EXCEL stent) deployment in the main branch (reference diameter: ≥ 2.5 mm and ≤ 4.0 mm,~     reference diameter of side branch: ≥ 2.0 mm and ≤ 3.5 mm, length of stenoses in either branch~     ≤ 30 mm) in the treatment of significant (>70%) de-novo-bifurcation stenoses of any Medina~     classification type in the native coronary artery as reflected by procedural success and to~     evaluate the preservation of vessel patency.~   "
98585|NCT02276833|"~     Autologous adipose-derived stromal vascular fraction (SVF) was used to treat 10~     osteoarthritic knees of grade II or III (K-L scale) under IRB-approved protocol in a~     feasibility and safety study. The adipose-derived SVF was obtained through disaggregation of~     lipoaspirate and resuspension of the SVF in 3 ml of Lactated Ringer's Solution, with a mean~     of 48 million nucleated SVF cells and a mean viability of 78%, injected per knee. Cell~     suspension was injected into the intra-articular space using ultrasound guidance. At 12 weeks~     post-op all 10 knees showed decreased pain and increased mobility, both statistically~     significant (α = .01). Nine of ten knees reported either maximum possible or very significant~     decrease in pain. No infections, acute pain flares, or other adverse events were reported.~     Patient ages ranged from 52 - 69 years with a mean of 59 years.~   "
98605|NCT02276573|"~     Oral lichen planus (OLP) is a chronic inflammatory and relapsing. The average prevalence is 1~     to 4%. The clinics forms are many and symptoms are varied. The erosive form, painful and~     debilitating is characterized by erosive areas, ulcerated on an erythematous base with or~     without a keratinocyte lichenien network.~      The literature data moving towards an autoimmune origin, but the pathophysiological~     mechanisms of OLP remain unknown.~      This project represents the first part of a comprehensive project to examine the oral~     pathogenesis of different viruses (Herpes and papillomavirus HPV) and centered on~     Epstein-Barr Virus (EBV).~   "
98586|NCT02276820|"~     Patients enrolled on this study will have received a stem cell transplant. After a~     transplant, while the immune system grows back the patient is at risk for infection. Some~     viruses can stay in the body for life, and if the immune system is weakened (like after a~     transplant), they can cause life-threatening infections.~      Adenovirus (AdV) is a virus that just causes symptoms of a common cold normally, but which~     can cause serious life-threatening infections in patients who have weak immune systems. It~     usually affects the lungs and can cause a very serious pneumonia, but it can also affect the~     gut, the liver, the pancreas and the eyes.~      Investigators want to see if they can use a kind of white blood cell called T cells to treat~     adenovirus infections that occur after a transplant. Investigators have observed in other~     studies that treatment with specially trained T cells has been successful when the cells are~     made from the transplant donor. However as it takes 1-2 months to make the cells, that~     approach is not practical when a patient already has an infection.~      Investigators have now generated AdV-specific T cells from the blood of healthy donors and~     created a bank of these cells. Investigators have previously successfully used frozen~     virus-specific T cell lines generated from healthy donors to treat virus infections after~     bone marrow transplant, and have now improved the production method and customized the bank~     of lines to specifically and exclusively target AdV.~      In this study, investigators want to find out if the banked AdV-specific T cells derived from~     healthy donors are safe and can help to treat adenoviral infection.~      The AdV-specific T cells (Viralym-A) are an investigational product not approved by the Food~     and Drug Administration (FDA).~      Funding source - FDA OOPD~   "
98587|NCT02276807|"~     The purpose of the Improving Mood in Veterans in Primary Care (IIR 14-047) is to evaluate a~     brief educational individual workshop that is meant to help Veterans better understand~     feelings of sadness and ways to improve their mood. This study is intended to evaluate and~     establish the workshop's effectiveness for use with Veterans in primary care settings.~      The study involves up to 6 in-person meetings and 6 telephone interviews across a 6-month~     period of time. Approximately 144 Veterans will participate in the study. Using a procedure~     like the flip of a coin, the participants will have a one in two chance of receiving the~     brief educational workshop or treatment as usual condition.~   "
98588|NCT02276794|"~     This study aims to verify the effects of Thrust Versus Non-thrust Manipulation on Pain, Trunk~     Proprioception and Postural Stability in Subjects With Chronic Low Back Pain.~   "
98589|NCT02276781|"~     The investigators hypothesize that among people with lower extremity peripheral artery~     disease (PAD), biomarker levels are higher during time periods immediately preceding an acute~     coronary event compared to time periods not immediately preceding an acute coronary event.~     Biomarkers the investigators will study are CRP, SAA, and D-dimer. Biomarkers will be~     measured at baseline and every two months during follow-up.~      The primary aims of this study are as follows. Specific Aim #1. Among participants with PAD~     who experience an acute coronary event during follow-up, the investigators will determine~     whether biomarker levels measured immediately prior to the coronary event are higher than~     levels that do not immediately precede coronary events. Specific Aim #2, Part 1. The~     investigators will determine whether participants who experience a coronary event (cases)~     have higher biomarker levels at the visit immediately prior to the event than participants~     who have not experienced a coronary event (controls) at the time of the case event. Specific~     Aim #2, Part 2. The investigators will determine whether participants who experience a~     coronary event (cases) have a greater increase in biomarkers during the time period leading~     up to the event compared to participants who have not experienced a coronary event~     (controls).~      To achieve these aims, the investigators will enroll up to 650 participants with PAD and~     follow them prospectively, measuring blood samples every two months, and ascertaining the~     presence of acute coronary events every two months.~   "
98590|NCT02276768|"~     This study evaluates colonic analgesia by comparing two novel formulations, GIC-1001 and~     GIC-1002 with placebo using a barostat distender. The healthy male and female volunteers~     randomized to one of 5 possible treatments will be exposed to rectal distension following a~     3-day treatment TID. The barostat methodology is a well-established and validated way to~     assess visceral pain. Visceral pain will be evaluated during exposure to varying distender~     pressures using a visual analog scale.~   "
98591|NCT02276755|"~     The goal of this clinical trial is to investigate the preventive role of vitamin D~     supplementation in school age children in a high transmission setting. The investigators~     hypothesis is that (1) vitamin D supplementation will reduce rate of acquisition of LTBI, (2)~     vitamin D supplementation will lead to greater reductions in active TB incidence, and (3)~     children with the lowest vitamin D status at baseline will gain most from the intervention.~   "
98592|NCT02276742|"~     The purpose of this randomized clinical trial is to evaluate the efficacy of 3 different~     technology-supported approaches to engaging 300 individuals with diabetes and concurrent~     chronic kidney disease in weight loss, dietary sodium restriction, and dietary restriction of~     inorganic phosphates when compared to usual care. Participants will be randomized to 1 of 4~     groups, Usual Care (UC), Social Cognitive Theory-based Group Counseling (SCT), Mobile~     self-monitoring with tailored feedback and counseling (MONITORING), or a combination of SCT~     plus MONITORING conditions (COMBINED). Investigators will evaluate the intervention arms~     primarily in terms of weight reduction, urinary sodium excretion, and serum phosphorus and,~     secondarily in terms of physical activity, blood pressure, fasting lipids, medication~     requirements, and pulse wave velocity. Measurements will occur at baseline, 6, and 12 months.~     The statistical modeling of the baseline, 6 mos and 12 mos outcome variables will be based on~     logistic generalized linear mixed models (for binary outcomes) linear mixed models (for~     continuous outcomes), and random effects multinomial models (for outcomes with more than 2~     levels, such as changes in medication management). In separate analyses of the intervention~     arm only, investigators will model self-monitoring adherence and examine possible~     associations between self-monitoring adherence and outcomes. The mediating effect of~     self-efficacy on the primary outcomes will be evaluated using structural equation models.~   "
98606|NCT02276560|"~     The purpose of this research study is to determine whether giving cisplatin and~     nab-paclitaxel before surgery will reduce the presence of disease in certain areas of the~     lung at the time of surgery.~   "
98607|NCT02276547|"~     The purpose of this study is to evaluate the safety and initial performance of the Neovasc~     Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System.~   "
98594|NCT02276716|"~     Familial dysautonomia (FD) is a devastating hereditary disease in which the development of~     selective neuronal populations is impaired because of a deficiency of the protein IKAP~     (Slaugenhaupt, 2002). There is no known cure. Treatments are supportive, often ineffective~     and around half of all patients die before reaching age 40 (Axelrod et al., 2002).~      Phosphatidylserine is an FDA approved food supplement that was shown recently to correct the~     genetic abnormality and restore IKAP protein levels in cell lines derived from patients with~     FD (Keren et al., 2011) and a humanized mouse model of the disease (Bochner et al., 2013).~     Despite its safety and efficacy in this fragile population being unknown, many patients with~     FD are currently taking phosphatidylserine~      The investigators propose to conduct a safety, tolerability and early proof of concept~     efficacy study of phosphatidylserine in patients with FD. The study will be divided into two~     independent arms. The first phase of the study will be an open-label dose titration study to~     determine the safety and optimal dose of phosphatidylserine and its effect of normal IKBKAP~     mRNA levels in 40 patients with FD. The second phase will be a longitudinal observational~     study in which we will follow, on a yearly basis, patients with FD of all ages who opt to~     take phosphatidylserine. In this study, we will evaluate the long-term safety of~     phosphatidylserine in patients with FD and hope to determine whether phosphatidylserine has~     any impact on the clinical evolution of the disorder.~      Our long-term goal is to find an effective therapy that will improve the quality of life for~     patients with FD and alter disease prognosis. We believe that the promise of~     phosphatidylserine and its availability in health food shops warrants a controlled safety,~     tolerability and efficacy study to determine whether it should be taken by patients with FD.~     This study is not intended to determine whether phosphatidylserine has a new indication to~     treat FD.~   "
98595|NCT02276703|"~     Pain in hospitalized patients has received increasing attention, however due to its~     subjective nature, it has defied objective, quantitative measurements. If a patient is able~     to communicate, pain may be assessed using standardized sentences, visual analog scales (VAS)~     or plain numeric scales.~      When a patient is unable to communicate, a method that would allow the caregiver to~     continuously monitor patients' pain and alert the provider that the patient may be in pain~     would be quite useful. The Pain Monitor uses a novel measurement technique of analyzing~     changes in skin conductance that can be used in patients who are unable to provide a~     subjective pain score. This study will compare the relationship between the measurements~     taken by the PainMonitor and pain scores given by communicative patients to evaluate the~     safety and efficacy of this monitor during planned, routine procedures.~   "
98596|NCT02276690|"~     Anaemia is very frequent among critically ill patients, concerning more than 60 % of them at~     admission and more than 80% at intensive care unit discharge. Iron deficiency is also~     frequent at admission, with prevalence around 25 to 40%. During their stay in Intensive Care~     Unit, critically ill patients are exposed to repeated blood samples and to other blood losses~     (daily blood loss has been evaluated to be as high as 128 ml/day in median), this leads to~     direct iron loss. Prevalence of iron deficiency may thus be very important at Intensive Care~     Unit discharge. However, iron deficiency diagnosis is complicated in these patients, since~     inflammation induces an increase in plasma ferritin levels and a decrease in transferrin~     saturation, the two usual markers of iron deficiency. As a consequence, iron deficiency is~     usely under-diagnosed in these patients. Treatment of iron deficiency may be indicated to~     correct anaemia but also to improve patients fatigue and muscular weakness. The~     characterization of iron metabolism regulation by the hormone hepcidin opened new ways for~     the understanding and the follow-up of these complex clinical situations (combining~     inflammation and iron deficiency). Indeed, iron deficiency is associated with a decrease in~     hepcidin synthesis, while iron overload induces hepcidin synthesis. Furthermore, low hepcidin~     levels are required to mobilize iron from stores. Hepcidin has thus be proposed as a marker~     of iron deficiency in critically ill patients. To date, standard immunological methods of~     hepcidin quantitation are only proposed in the reasearch setting and could not be proposed in~     the clinical setting because it is too expensive. New approaches for hepcidin quantification,~     based on mass spectrometry are proposed and may be routinely implemented. We make the~     hypothesis that treating iron deficiency in critically ill anemic patients, diagnosed by~     hepcidin quantification, may improve the post-Intensive Care Unit rehabilitation, and may~     thus reduce post-Intensive Care Unit cost linked to hospital stay and anaemia treatment.~      The aim of this study is to evaluate the medical economic interest of a new diagnostic method~     for iron deficiency, based on a quantitative dosage of hepcidin by mass spectrometry in~     critically ill anaemic patients.~   "
98597|NCT02276677|"~     Oxytocin is a peptide hormone produced in the brain that regulates food intake. However, the~     mechanisms for this effect in humans is not yet clear.~      In this study, the investigators will therefore examine the effect of a single dose of~     intranasal oxytocin (compared to placebo) on levels of appetite-regulating hormones and~     functional magnetic resonance imaging activation of areas of the brain involved in food~     motivation.~   "
98598|NCT02276664|"~     The purpose of this study is to develop and test a self-help smoking cessation treatment for~     patients receiving a lung cancer screening computed tomography (CT) scan.~   "
98599|NCT02276651|"~     Application of a therapeutic platelet transfusion Regimen in patients with acute myeloid~     leukemia in complete Remission (consolidation therapy)~   "
98600|NCT02276638|"~     The primary objective of this clinical study is to collect clinical data to support an FDA~     510(k) submission for the Nidek CEM-530 Center point method and Corner point method. The~     secondary objective is to evaluate any adverse events found during the clinical study.~   "
98601|NCT02276625|"~     To determine optimum dose level for a single visit multidose intradermal injection of rabies~     vaccine with the aim to induce immunological memory in all subjects.~   "
98602|NCT02276612|"~     The primary objective of this study is to evaluate the safety and tolerability of~     elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) in HIV-infected~     virologically suppressed adolescents 12 to < 18 years of age.~   "
98603|NCT02276599|"~     This study is designed to investigate the ability of pleth variability index (PVI) to~     non-invasively predict fluid responsiveness in mechanically ventilated children. Patients~     undergoing atrial septal defect (ASD) repair in the cardiac catheterization suite will be~     recruited for this study. These patients are ideal candidates because very few deviations~     will be made from standard clinical practice. All patients will already be under general~     anesthesia, mechanically ventilated, monitored with pulse oximetry, and provided with~     intravenous fluid to compensate for their nil per os (NPO) fluid deficit. The only deviation~     from clinical practice will include an abbreviated echocardiographic exam, application of the~     Masimo pulse oximeter, and measurement of CO via a thermodilution catheter by the~     interventional cardiologist.~   "
98604|NCT02276586|"~     Background: The actual literature is consistent in considering potential negative effects of~     sub-gingival prosthetic margins on the periodontal health, but no research has focused the~     attention on the type of prosthetic margin designs. Hence, the aim of the present study is to~     evaluate if a horizontal finishing line (deep chamfer preparation) may have a different~     influence on periodontal soft tissue in comparison with a vertical finishing line (feather~     edge preparation).~      Methods: A prospective randomized controlled double blind clinical trial with one single~     operator and three experienced examiners was performed. One hundred and six crowns were~     prepared with horizontal tooth preparation while ninety-four with vertical tooth preparation.~     All the margins were positioned within the periodontal sulcus, at 0.5mm sub-gingivally and~     all the all-ceramic restorations were cemented with resin cement. Periodontal Probing Depth~     (PPD), Plaque Index (PI), Gingival Index (GI) and Gingival Bleeding on Probing (BOP) were~     recorded prior to tooth preparation and twelve month after crown cementation. Also, at 12~     months follow-up, the gingival margin position was related to the crown margin position.~   "
98609|NCT02276521|"~     In Fiji, cervical cancer is the second most frequent cancer and the highest cause of cancer~     mortality in women. In 2008/9, the Ministry of Health in Fiji accepted a donation of 110,000~     doses of quadrivalent HPV vaccine, Gardasil® based on the high cervical cancer disease~     burden. There was enough vaccine to vaccinate all girls aged 9-12 years (30,338 girls) with a~     three-dose schedule, but not all girls received three doses of the vaccine. This means those~     girls that received reduced doses may not be fully protected against the HPV genotypes~     present in the Gardasil®. While HPV vaccines are highly immunogenic and efficacious in the~     licensed three-dose schedule, there is limited information about the effectiveness of reduced~     dose schedules in terms of immunogenicity and memory. There is growing evidence from other~     studies that two doses of HPV vaccine may be sufficient for protection. Reduced schedules~     would be of benefit in Fiji due to improved costs and logistics. This study will examine~     whether one or two doses of HPV vaccine provide similar immunological evidence of long-term~     protection to the standard three-dose schedule in terms of antibody titres to the genotypes~     present in the Gardasil®. To compare immunological memory responses between dosage groups, a~     dose of Cervarix ® will be administered to all girls so that the magnitude of the memory~     responses can be measured.~   "
98610|NCT02276508|"~     Nissle 1917 is an E. coli based probiotic used in the Europe for close to 100 years to treat~     gastrointestinal disorders and infections. The investigators will assess the safety and~     tolerability of this medication in Americans in a Phase 1 trial.~   "
98611|NCT02276495|"~     The purpose of the study is to determine the effect of a single injection adductor canal~     block (ACB) on pain scores within 24 hours post total knee arthroplasty (TKA).~   "
98612|NCT02276482|"~     The purpose of the study is to compare the safety of intravenous (IV) and/or oral 6-day 200~     mg tedizolid phosphate with 10-day comparator in participants 12 to <18 years with cSSTI.~   "
98613|NCT02276469|"~     The purpose of this study is to determine wether peer support is effective for the treatment~     of people with severe mental illness.~   "
98614|NCT02276456|"~     With no prior prospective study to demonstrate the benefit of an early post-discharge~     follow-up appointment in reducing readmission rates in the post-myocardial infarction (MI~     patient population, we propose to conduct the first randomized, prospective trial to better~     elucidate the association between early and standard follow-up on readmission rates. The~     investigators hypothesize that unlike heart failure or advanced valvular disease patients,~     the benefit of early outpatient follow-up in reducing readmission of post-MI patients will be~     less clear. Thus, the investigators primary aim will be to determine the effect of early~     outpatient follow-up post-discharge on 90 day all-cause readmission rates (exclusive of~     planned readmissions known at the time of discharge). Secondary aims are to describe 1)~     causes of readmissions within 90 days, 2) any cardiovascular-related complications and any~     deaths that occur from discharge through 90 days, 3) 30-day readmission rates and 4) median~     time to readmission among those readmitted. Finally, the investigators will examine the~     distribution of demographic, clinical and socioeconomic characteristic according to~     readmission vs. no readmission. The investigators do not expect to have sufficient endpoints~     for full predictive modeling, but believe this exploratory work will provide a foundation for~     future studies. The investigators postulate that the design and methodology of our current~     study could be used to answer similar questions in other subsets of patients.~   "
98615|NCT02276443|"~     The goal of this clinical research study is to learn if the use of imaging response~     evaluations and molecular testing on tumors can improve response to treatment in patients~     with triple-negative breast cancer (TNBC) by guiding patients with chemotherapy-sensitive~     tumors to receive standard chemotherapy and chemotherapy-insensitive tumors to consider a~     clinical trial.~      Up to 360 patients will take part in this study. All will be enrolled at MD Anderson.~   "
98616|NCT02276430|"~     Testicular cancer (TC) is a rare disease, which mostly affects young men aged 15-35 years.~     Their life expectancy has greatly improved due to the introduction of platinum-containing~     chemotherapy for disseminated TC in the late 1970s. Given the good prognosis of TC nowadays,~     prevention or early detection of late adverse effects of TC treatment has become increasingly~     important. Current literature suggests that TC treatment, and specifically exposure to~     platinum agents, is associated with increased risk of cardiovascular morbidity and mortality.~     The precise role of treatment components like platinum in the pathogenesis of cardiometabolic~     changes and cardiovascular disease (CVD) warrants further investigation, since it is not~     known if CVD develops through direct platinum-induced damage of the vascular wall or by~     mediation through development of cardiometabolic riskfactors. The aim of this study is to~     identify risk factors for development for CVD after treatment for TC. A more profound insight~     into pathophysiologic mechanisms and identification of risk factors for CVDs is needed to~     facilitate development of preventive strategies and to optimize survivorship care.~   "
98617|NCT02276417|"~     The purpose of this study is to define the natural history and causes of chronic critical~     illness (CCI) in surgical intensive care patients who have had sepsis. The investigator also~     wants to define the long-term physical and cognitive outcomes of this disease. The~     investigator will be looking at many clinical variables to try to define CCI.~   "
98618|NCT02276404|"~     Breast cancer surgery is associated with presurgical psychological distress and clinically~     significant side effects including postsurgical pain, nausea and fatigue. A few studies have~     examined how to intervene to assist women undergoing breast cancer surgery. For example~     presurgical hypnosis has been proven to decrease side effects and even intraoperative~     anesthesia use. Besides the more psychologically based interventions there are a few studies~     suggesting positive effects of acupuncture on pain, anxiety and nausea in surgery~     patients.This study aims to investigate whether a presurgical relaxation training,~     acupuncture treatment or a combination of both therapies is able to reduce presurgical~     psychological distress an postsurgical side effects in breast cancer patients in comparison~     to usual care.~   "
98619|NCT02276391|"~     To establish bioequivalence of telmisartan orally administrated in two different ways: either~     with a telmisartan 80 mg/hydrochlorothiazide (HCTZ) 12.5 mg fixed-dose combination tablet or~     with two telmisartan 40 mg tablets~   "
98620|NCT02276378|"~     To investigate the relative bioavailability and pharmacokinetics of the fixed-dose~     combination tablets (telmisartan 40 mg/HCTZ 12.5 mg and telmisartan 80 mg/HCTZ 12.5 mg) after~     food intake in comparison with those in the fasting state in healthy Japanese male volunteers~   "
98623|NCT02276339|"~     This study aims to investigate the activity patterns of the peroneal muscle group, in~     individuals with a history of chronic ankle instability (CAI) of the ankle injuries compared~     with individuals without ankle problems. The study also aims to determine the effect of a~     targeted exercise programme on this muscle group in patients with CAI.~      Research on this topic may provide important insight on the roles of these muscles in chronic~     ankle instability and investigate whether specific strengthening programmes are effective in~     this complex patient category.~   "
98624|NCT02276326|"~     Aim of the study is to evaluate the effects of a change in the intestinal microflora on the~     neuro-cognitive profile of patients with HIV infection receiving HAART treatment.~     Improvements will be evaluated with questionnaires on Quality of life and Cognitive and~     Behavior function.~      20 patients will be enrolled and will receive 4 sachets of VSL#3 per day.~   "
98625|NCT02276313|"~     BIOLUX P-III is a prospective, international, multi-centre, postmarket all-comers registry to~     collect clinical performance data on the Passeo-18 Lux paclitaxel releasing balloon catheter~     in the treatment of atherosclerotic disease of the infrainguinal arteries.~   "
98626|NCT02276300|"~     Investigation of peptide vaccination targeting HER2/neu in patients with metastasized breast~     or gastric cancer with moderate HER2/neu expression.~   "
98627|NCT02276287|"~     Background: the study aimed to explore HIV positive patients' perceptions toward illness and~     treatment, and their associations with demographic and clinical variables, in particular with~     adherence.~      Methods: the study was conducted at the outpatients clinic of Infectious Disease of a~     University Hospital in the north of Italy. Patients were asked to fill out the Illness~     Perception Questionnaire-Revised. Patient's adherence was measured by: viral load (HIV-RNA~     copies/ml) and presence at the check up.~   "
98628|NCT02276274|"~     This is a randomized, open-label, crossover study to determine the effect of food when a~     combination tablet of SYR-322 and metformin hydrochloride ( hereinafter referred to as~     SYR-322-MET tablet) is orally administered under fasting conditions in the morning or after~     breakfast in Japanese healthy adult male subjects.~   "
98629|NCT02276261|"~     This study has been designed as a prospective randomized trial to be performed at Bridgeport~     Hospital. Patients planning to undergo a laparoscopic or robotically assisted total~     laparoscopic hysterectomy with or without removal of adnexal structures will be recruited by~     the Bridgeport Hospital Minimally Invasive Gynecologic Surgery fellows during their~     preoperative office visit at the Bridgeport Hospital Gynecologic Oncology office. If~     enrolled, they will be assigned a sequential study identification number. During their~     preoperative exam, a baseline POP-Q will be performed. Demographic information will be~     recorded from the electronic medical record.~   "
98630|NCT02276248|"~     This study is to evaluate the efficacy and safety of radiotherapy combined with GDP~     (gemcitabine, cisplatin, dexamethasone) chemotherapy in stage I/II extranodal natural~     killer/T-cell lymphoma patients with unfavorable prognostic factors.~   "
98631|NCT02276235|"~     The aim of this double-blind, randomized, placebo-controlled trial is to evaluate the~     therapeutic effects of acupoint stimulation by catgut embedding on complexion, quality of~     life, lipid profile, inflammatory markers, and obesity-related hormone peptide of obese~     women.~   "
98632|NCT02276222|"~     This is a long-term safety trial of 48 weeks. Eligible subjects will enter the 48-week,~     open-label treatment period to receive one of two treatments (SUN-101 given as 50 mcg twice a~     day or Spiriva® [tiotropium] given as 18 mcg once a day).~   "
98633|NCT02276209|"~     This is a randomized, double blind, multicenter, parallel group, outpatient study evaluating~     the efficacy and safety of dasotraline in adults with ADHD.~   "
98634|NCT02276196|"~     Based on preclinical and small-sized studies in non-diabetic individuals, incretin-based~     therapies, i.e. glucagon-like peptide (GLP)-1 receptor agonists and dipeptidyl peptidase-4~     inhibitors, may hold promise in preventing the onset and progression of diabetic kidney~     disease. However, the potential renoprotective effects of these agents, that are believed to~     be effectuated beyond glucose control, have not been sufficiently detailed in human~     diabetes.~      Therefore, the present study aims to explore the mechanistic and clinical effects of GLP-1~     receptor agonists on renal physiology and biomarkers in patients with type 2 diabetes.~      Forty patients with insulin-treated type 2 diabetes will undergo an eight week intervention~     with lixisenatide or insulin glulisine in order to assess changes in the outcome parameters.~   "
98635|NCT02276183|"~     Bone and muscle losses occur during ageing leading to increased risk of osteoporosis (there~     are more than 200 million people affected by osteoporosis worldwide), sarcopenia, loss of~     functionality and mobility. From around 45-50 years onwards, there is a progressive loss of~     muscle mass and strength (sarcopenia). This is partially due to an impairment of muscle~     protein synthesis in response to dietary proteins. Insufficient dietary protein may~     contribute to age-related loss of lean body mass (LBM) and strength which ultimately affects~     body movement.~      Key ingredients in selected investigational product are:Milk proteins, Calcium, Vitamin D,~     Vitamin C, Glucosamine Sulfate, Zinc. They have effects to improve physical mobility and~     functionality. The investigators expect improved effects of a nutritional intervention~     combined with a physical activity program on mobility in healthy aging subjects with joint~     discomfort.~   "
98636|NCT02276170|"~     Acute kidney injury (AKI) in critically ill neonates is common and associated with~     significant morbidity and mortality. No targeted therapeutic treatment strategies have been~     established for AKI in neonates. Within a clinical pharmacokinetic and pharmacodynamic~     conceptual framework, this project will examine the medication aminophylline as a potential~     treatment approach for AKI.~   "
98637|NCT02276157|"~     This study was aimed to evaluate of the success rate and clinical usefulness of direct~     peroral cholangioscopy by using an ultra-slim upper endoscope for the diagnosis and treatment~     of bile duct diseases.~   "
98638|NCT02276144|"~     The aim of this study is to evaluate the prevalence of metabolic syndrome, liver function~     abnormality and non-alcoholic fatty liver disease in early pregnancy patients, and the risk~     of pregnancy complications.~   "
98639|NCT02276131|"~     A human factors and home use study to assess whether subjects with diabetes and their~     caregivers can understand feedback received from the Vigilant Diabetes Management Application~     about their blood glucose patterns and whether the decisions made in response to device~     feedback are made in accordance with the intended use.~   "
98640|NCT02276118|"~     Recently, E.Motion-PS-Pro (B.Braun-Aesculap, Tuttlingen, Germany), a new mobile bearing knee~     system with a unique ball and socket post-cam mechanism was developed for use in total knee~     arthroplasty. This study aims to determine (1) whether the use of E.Motion-PS-Pro improves~     prosthesis fitness for the femur and tibia in terms of under- or over-hang incidence compared~     to an established successful prosthesis, Genesis II (Smith & Nephew, Memphis, U.S.A.), (2)~     whether patients with this new prosthesis experience less pain and faster wound healing in~     early recovery phase, (3) whether patients with E.Motion-Pro reach functional plateaus faster~     than patients with Genesis II and the functional plateaus of patients with E.Motion-Pro are~     higher than those of patients with Genesis II.~   "
98641|NCT02276105|"~     The purpose of this study is to determine how appropriate and practically is the EQ-5D~     questionnaire in use on patients with carpal tunnel syndrome undergoing surgery along the~     change of quality of life.~   "
98642|NCT02276092|"~     This study evaluates the effectiveness of an antimicrobial stewardship program to reduce the~     length of stay of patients admitted to hospital with a diagnosis of pneumonia. The~     antimicrobial stewardship program will be implemented in several hospitals in Ontario,~     Canada. The program will identify patients with pneumonia, review their charts and make~     recommendations to their attending physicians about antibiotic management.~   "
98643|NCT02276079|"~     The study is a proof-of-principle project to examine the safety and feasibility of~     implementing a 1-week aerobic exercise program in the post-acute phase after mild traumatic~     brain injury (mTBI). The study will define the extent to which the exercise program improves~     recovery from mTBI in terms of relevant functional outcomes (cognition, mood, and physical~     status) and biomarkers (peripheral brain-derived neurotrophic factor [BDNF] concentration).~   "
98644|NCT02276066|"~     This study investigates the mechanism by which kidney dysfunction perpetuates inflammation,~     immunosuppression, and catabolism (PICS) in chronic critical illness. The investigators will~     test the hypothesis that persistent kidney dysfunction in sepsis associated by chronic~     critical illness contributes to decreased survival through the development of PICS. In~     chronic critical illness, the persistence of the inflammatory state may lead to capillary~     rarefication in the kidney causing accelerated chronic kidney disease. Progression of chronic~     kidney disease during chronic critical illness can drive PICS. Indeed, many of the features~     of chronic critical illness are consistent with the protein-energy malnutrition and muscle~     wasting associated with chronic kidney disease. Thus, the kidney can play a contributory role~     in chronic critical illness and PICS.~   "
98645|NCT02276053|"~     This study is being conducted to find out whether lacosamide (a drug to treat epilepsy) is~     effective in routine clinical practice for patients with epilepsy caused by a brain tumor.~   "
98646|NCT02276040|"~     The purpose of this study is to quantify the total blood serum levels of bupivacaine in~     OrthoPAT® collected blood 2 hours and 5 hours postoperatively.~      Hypothesis: Filtered blood from the OrthoPAT® autotransfusion system contains low or~     undetectable levels of bupivacaine hydrochloride (HCL). Reinfusion of collected blood from~     the OrthoPAT® device when used in conjunction with periarticular bupivicaine injections will~     not pose a bupivocaine toxicity risk to patients undergoing a total joint arthroplasty.~   "
98647|NCT02276027|"~     To investigate the anti-tumor activity of single agent BYL719, INC280, LDK378 and MEK162~   "
98648|NCT02276014|"~     Summary:~      Chronic intake of foods low in vitamin A (retinol) and provitamin A forming an unbalanced~     diet with little variety is common in young individuals in the United Kingdom (UK) population~     and can lead to subclinical micronutrient deficiency. Provitamin A sources such as β-carotene~     are cleaved centrally by the β-carotene 15,15'-monooxygenase (BCMO1) into retinal, the~     precursor of retinol. However, the amount of β-carotene and retinol produced after ingestion~     of β-carotene is highly variable between healthy individuals, with approximately 40% of the~     subjects being classified as low responders. Several stable isotope studies have shown a~     large disparity between the most efficient converters and the most inefficient converters of~     β-carotene with variations of up to 8-fold. It is possible that differences in β-carotene~     response may be due to single nucleotide polymorphisms (SNPs) in genes involved in aspects of~     β-carotene conversion. Previous work has shown that carriers of both, the 379V and 267S+379V~     BCMO1 variant alleles had a reduced ability to convert β-carotene. More importantly, 44% of~     the western population have the 379V haplotype. A high percentage of the Western population~     may therefore not be able to achieve adequate vitamin A intake if dietary β-carotene is a~     major source of their vitamin A intake. This is of particular relevance to vegetarians, to~     young individuals aged 19-24 years who have lower intakes of preformed retinol than any other~     age group, and to pregnant women. The aim of this study is to establish whether the maximum~     recommended dose for β-carotene of 7mg/day by the British Expert Committee on Vitamins and~     Minerals (EVM) can overcome the SNP effect in the BCMO1 enzyme.~      Hypothesis:~      The investigators hypothesize that the current maximum recommended intake of 7 mg of~     β-carotene per day cannot overcome the low convertor phenotype in BCMO1 to fulfill vitamin A~     requirements in these people.~   "
98649|NCT02276001|"~     The primary objective of this study is to assess the effects of cyclosporine on the~     pharmacokinetics of K-877 in healthy adult subjects.~   "
98650|NCT02275988|"~     The purpose of this study is to assess the effects of clarithromycin on the pharmacokinetics~     of K-877 in healthy adult subjects.~   "
98651|NCT02275975|"~     The purpose of this study is to assess the effects of fluconazole on the pharmacokinetics of~     K 877 in healthy adult subjects.~   "
98652|NCT02275962|"~     The purpose of this study is to assess the effects of rifampin on the pharmacokinetics of~     K-877 in healthy adult volunteers.~   "
98653|NCT02275949|"~     This study will evaluate acupuncture's effect of preventing vasospasm after SAH.~      A total of 80 participants will be recruited and will be randomized to a study group or a~     control group. Acupuncture, electroacupuncture and intradermal acupuncture will be done at~     every session in a study group, while mock transcutaneous electrical nerve stimulation(mock~     TENS) and sham intradermal acupuncture will be carried out in a control group.~   "
98654|NCT02275936|"~     This Phase 1b study in F508del-CFTR homozygous CF patients is being conducted to assess the~     safety of N91115 as the sole cystic fibrosis transmembrane conductance regulator (CFTR)~     modulator at doses near the expected therapeutic exposure level in preparation for Phase 2~     studies of N91115 added to the CFTR modulator combination lumacaftor/ivacaftor when launched.~   "
98655|NCT02275923|"~     The purpose of this study is to investigate the use of subcutaneous impedance measured with~     an implanted Medtronic Reveal LINQ™ insertable cardiac monitor for use as a fluid status~     monitor in hemodialysis patients. The study will measure the changes in subject subcutaneous~     impedance and compare with the fluid status assessed by the volume removed from the~     hemodialysis subject during dialysis sessions. Subcutaneous impedance trends will also be~     evaluated between dialysis sessions.~   "
98656|NCT02275910|"~     This is a Phase 1 study of E7090 in subjects with advanced solid tumors. This study will be~     conducted in 2 parts:~        1. Part 1 will be the dose escalation portion of this study to determine the maximum~          tolerated dose in subjects with solid tumors, and~        2. Part 2 will comprise cohort expansions to further characterize the safety and~          tolerability of E7090 and to assess preliminary efficacy of E7090 in subjects with solid~          tumors characterized by genetic abnormalities in FGF/FGFR pathway.~   "
98657|NCT02275897|"~     The purpose of this study is to investigate if prolonging the speed of injection during~     spinal anaesthesia can reduce the incidence of hypotension and/or medication requirements~     thereby making it safer for the mother and foetus.~   "
98658|NCT02275884|"~     This study evaluates plasma concentrations of pharmacologically active constituents of~     chocolate and their effects on motor and non-motor symptoms of Parkinson's disease. Following~     one week of abstinence from cocoa-containing products, patients with Parkinson's disease will~     be randomized to receive either dark or white chocolate. After one week of chocolate~     consumption, patients will then cross over to white or dark chocolate, respectively, and take~     the corresponding chocolate product for another week. Blood samples will be taken at~     baseline, week 1 and week 2 to examine plasma concentrations of pharmacologically active~     constituents of chocolate at all three timepoints. Moreover, patients will be clinically~     examined for motor and non-motor symptoms at all visits.~   "
98659|NCT02275871|"~     This research study is comparing Dual-Energy Contrast-Enhanced Spectral Mammography (CESM) to~     MRI as a screening tool for breast cancer.~   "
98660|NCT02275858|"~     Balloon assisted enteroscopy has revolutionized the management of small bowel diseases by~     enabling endoscopic access deep into the small bowel. Using a combination of antegrade~     (through the mouth) and retrograde (through the anus) approaches, a large portion of the~     small bowel can be examined. Access to the proximal small bowel through the pylorus using the~     antegrade approach is straightforward but intubating the distal small bowel through the~     ileocecal valve is challenging due to the flexibility of the enteroscope. Recently, an~     enteroscopy stiffening wire has been developed. The purpose of our double blind placebo~     controlled randomized cross over study is to evaluate the performance of the enteroscopy~     stiffening wire in achieving terminal ileum intubation (TI) during retrograde balloon~     assisted enteroscopy.~   "
98661|NCT02275845|"~     Metformin vs Control to prevent gestational diabetes mellitus (GDM) in women with a high risk~     for GDM, an open label randomized controlled trial' The Medico-GDM trial~   "
98662|NCT02275832|"~     The purpose of this study is to determine efficacy and safety of 3% minoxidil lotion for~     beard enhancement.~   "
98663|NCT02275819|"~     This is a research study being conducted to better understand the impact of exercise training~     on changes on the structure and function of the heart. Exercise training in patients with~     heart failure has been shown to be beneficial at decreasing symptoms of heart failure and~     improving overall functional capacity or capacity to exercise. However the mechanisms~     responsible for this are still unclear. This study will look specifically at how exercise~     creates changes within the hearts filling ability, the hearts pumping strength as well as the~     hearts ability to rebuild.~   "
98664|NCT02275806|"~     This is a prospective, single institution phase II study, whose primary objective is to~     estimate the median and three year survival rate of non-small lung cancer patients with Stage~     IIIA and IIIB intra-thoracic disease which is referred to as locally advanced non-small~     cell lung cancer (NSCLC).~   "
98665|NCT02275793|"~     Peripheral blood and blood following a pulmonary wedge pressure will be obtained from~     patients undergoing right heart catheterizations.~   "
98666|NCT02275780|"~     To establish a new treatment option for treatment-naïve participants with HIV-1, the efficacy~     and safety of doravirine will be determined relative to a protease inhibitor (PI).~     Participants will receive double-blind treatment during the 96-week Base Study. Eligible~     participants in either of the Base Study groups will continue to receive the~     doravirine-containing regimen open label for an additional 96 weeks in the Study Extension 1.~     Eligible participants who are deriving benefit will continue in Study Extension 2 to receive~     the doravirine-containing regimen open label until doravirine becomes locally available or~     for an additional 96 weeks, whichever comes first. The primary hypothesis is that doravirine~     100 mg once a day (q.d.) is non-inferior to darunavir/ritonavir (800 mg/100 mg) q.d., each in~     combination with TRUVADA™ or EPZICOM™/KIVEXA™, as assessed by the proportion of participants~     with HIV-1 ribonucleic acid (RNA) <50 copies/mL at Week 48. If non-inferiority is~     established, then the superiority of doravirine 100 mg q.d. compared to darunavir/ ritonavir~     (800 mg/100 mg) q.d. will be assessed.~   "
98667|NCT02275767|"~     The study is a 3-arm, parallel-design, randomized, prospective clinical trial.designed to~     examine histologic wound healing following ridge preservation using cortical bone allograft,~     cancellous bone allograft, or a combination of both cortical and cancellous bone allograft.~     This entire protocol involves procedures that are standard care. All materials are~     FDA-approved materials being used in an FDA-approved manner. The test group subjects will~     have extraction sockets grafted with a combination of 50% cortical/50% cancellous FDBA. This~     test group will be compared to two active control groups - one using 100% cortical FDBA and~     the other using 100% cancellous FDBA. The null hypothesis is that there will be no~     significant difference in formation of new vital bone between treatment groups (primary~     outcome).~      Each subject will provide a single non-molar tooth site for study treatment. After tooth~     extraction, the graft material will be placed and covered by a non-resorbable membrane.~     Following 18-20 weeks of healing, the dental implant will be place, at which time a core of~     bone will be removed from the site as part of the preparation for the implant. The core~     biopsy will then be evaluated for the primary histologic outcome of % vital bone formation~     and secondary histologic outcome of % residual graft material.~   "
98692|NCT02275429|"~     Acute consequences of ultramarathon running are still unknown as very little research has~     been done on the matter. The investigators will assess the consequences on the metabolism of~     runners in the ultramarathon Madmen's Diagonal on Reunion Island. Data from the literature~     suggest that runners undergo loss of zinc, copper, iron, magnesium not unlike the loss of~     metabolites in systemic inflammatory response syndrome. The purpose of this study is to~     assess the metabolic disorders (selenium, zinc, vitamins B9 and B12) in ultramarathon~     runners, during and up to 28 days after the Madmen's Diagonal which takes place on Reunion~     Island every year in October.~   "
98668|NCT02275754|"~     This proposed 5-year Redes En Acción research study involves a mixed-methods approach that~     occurs in two phases across two distinct and diverse HL communities. The RCT involves a 2 X 4~     randomized repeated measures design with experimental condition (combined patient navigation~     [PN] over 3 months with access to LCNS PN services[PNLCNS] vs. a PN only condition) as the~     between-groups factor, and time-point (baseline/pre-randomization [T1]; post-PNLCNS [about~     3-months post-T1; T2], and about 6- [T3] and about 12-months [T4] follow-up post-T2) as the~     within-groups factor; total follow-up is 15 months. The investigators will compare the~     effects of the PNLCNS and PN only conditions on QOL and treatment follow-up compliance in 300~     (after attrition; n=100, Chicago and n=100, San Antonio) breast, colorectal and prostate HL~     cancer survivors with no evidence of metastatic disease.~   "
98669|NCT02275741|"~     The aim of this study is to determine whether prophylactic vaccines recommended are effective~     and safe in patients with multiple sclerosis(MS) under MS-specific therapy.~   "
98670|NCT02275728|"~     This study evaluates the action of the pelvic floor muscle training with and without EMG~     Biofeddback in the treatment of stress urinary incontinence in menopausal, peri and post~     menopausal women and their quality of life before and after the interventions.~   "
98671|NCT02275715|"~     The primary aim of the project is to develop and pilot a manualized, individually delivered~     Parent Training Program for Feeding Problems (PT-F) in children with autism spectrum disorder~     (ASD) to assess feasibility and parent acceptance of the program. The secondary aim of the~     project is to assess the success of the PT-F program in improving mealtime behavior problems~     when compared to the wait-list control.~      Exploratory aims include obtaining preliminary data on the impact of PT-F on child and parent~     functioning (reducing parent stress and improving parent sense of competency and parent-child~     interactions at mealtime), assessing the impact of treatment on interfering behaviors around~     mealtime/snack times, and measuring nutritional improvements after treatment.~   "
98672|NCT02275702|"~     The proposed study is a randomized, double-blind, placebo-controlled evaluation if a small~     dose of IV dexamethasone during induction anesthesia in association to pre and postoperative~     intercostal nerve block, improves quality of recovery of thoracoscopic lung resection~     patients.~   "
98673|NCT02275689|"~     This study compare the outcome (pain, function) after Radiofrequency microtenotomy (group I)~     and acromioplasty (group II) for treatment of rotator cuff tendinosis in the shoulder.~      The outcome of both methods will be compared to the physical therapy treatment (groupIII)~   "
98674|NCT02275676|"~     Nutrient deficiencies occur frequently in IBD patients. The absorption rate of nutrients in~     IBD is often limited by chronic inflammation, but is also commonly reduced by missing~     intestinal segments due to previous operations. Patients are predominantly affected by~     malnutrition, which is often resembled by weight loss, specific micronutrient deficits such~     as iron deficiency, vitamin B12 deficiency, folic acid deficiency, vitamin D deficiency and~     zinc depletion. The etiology of nutritional problems is multifactorial and not exclusively~     limited to active phases of the disease. Causes of malnutrition can be inadequate food~     intake, maldigestion, malabsorption or increased nutritional requirement. Malnutrition itself~     is associated with a delayed recovery of impaired wound healing, reduced quality of life and~     longer hospital stays. Therefore, observation and modification of the nutritional status~     should be an integral part of therapy in IBD patients.~      The primary objective of our study is to investigate the influence of the disease on the~     resting energy expenditure and nutritional status during acute inflammation and clinical~     remission of the disease. Secondary objectives are to assess possible nutritional~     deficiencies. On the other hand it is well known that patients with IBD are at increased risk~     for coronary heart disease. Therefore, another secondary focus of our observational study is~     whether the composition of the HDL proteins is changed towards pro-atherogenic HDL-proteins~     and whether possible changes occur in patients in clinical remission or with active disease.~   "
98675|NCT02275663|"~     The purpose of this phase 2 study is to test the efficacy of azacytidine given prior to~     fludarabine, cytarabine, and G-CSF for the treatment of relapsed or refractory acute myeloid~     leukemia.~   "
98676|NCT02275650|"~     The investigators investigated the ability of narrowband ultraviolet B (nbUVB) treatment in~     the maintenance of vitamin D levels achieved during the summer in Finland. The investigators~     randomized 37 subjects into groups of 17 and 18 subjects. The other group received 2 standard~     erythema doses (SED) nbUVB exposure every other week until week 24, and serum 25(OH)D levels~     were measured at the onset and at weeks 6, 14, 20, 26 and 30. The control group was not~     illuminated and serum samples were analyzed correspondingly. Punch biopsies were taken at the~     onset and at week 14 for CYP27A1 and CYP27B1 enzyme expression level analyses.~   "
98677|NCT02275637|"~     The study is a prospective multicenter registry. Consecutive patients with indications of~     implant / replacement or upgrade of implantable cardioverter defibrillator (ICD) will be~     enrolled.~      The primary objective of the study is to determine the predictors of appropriate~     anti-tachycardia therapy (with shock) in a non-selected population of patients implanted with~     an ICD.~      Secondary objectives of the study are:~        -  the incidence of anti-tachycardia therapies;~        -  the predictors of inappropriate therapy and onset of arrhythmia burden;~        -  the adherence to the current guidelines in the Italian clinical practice;~        -  the predictors of heart failure (HF) onset and response to cardiac resynchronization~          therapy (CRT).~   "
98678|NCT02275611|"~     This study will test in individuals who have alcohol dependence (alcohol addiction) the~     hypotheses 1) that intranasal oxytocin treatment will decrease withdrawal symptoms during~     medical detoxification and 2) that intranasal oxytocin treatment for 12 weeks in the~     outpatient setting will decrease drinking.~   "
98679|NCT02275598|"~     The purpose of this study is to assess the efficacy of two three-weekly 1.8 mg/kg Brentuximab~     vedotin administrations in untreated patients with Hodgkin Lymphoma (HL).~   "
98680|NCT02275585|"~     This study evaluates the supervivence of cirrhotic patients that develop portal vein~     thrombosis in comparison to cirrhotic patients that do not develop portal vein thrombosis.~   "
98693|NCT02275416|"~     This study, with 20 patients participating, will examine the safety and tolerability for the~     ipilimumab/UV1 combination in patients with unresectable or metastatic malignant melanoma.~   "
98681|NCT02275572|"~     Objective: To evaluate the clinical and economic impact of the application of an algorithm to~     improve the adequacy and safety of pharmacotherapy in elderly polymedicated (receiving 8 or~     more medications), not institutionalized.~      Design: randomized, open, multicenter and two branches of parallel intervention clinical~     trial.~      Intervention Study: primary care pharmacist apply the GP-GP algorithm to each drug with the~     support of STOPP criteria, Beers and / or recommendations CatSalut. The pharmacist submit to~     doctor his findings and reach a consensus and decide which recommendations will be presented~     to patient. Control intervention: usual procedure.~      Main outcome measures: a) Discontinued medications, changed or changing doses, b) GP~     consultations, hospital emergency department and hospital admissions for acute illness, c)~     pharmaceutical expenditure, d) restart medication e) complications underlying diseases.~     Follow-up control at 1 month (security) and at 3, 6 and 12 months.~   "
98682|NCT02275559|"~     Asthma is one of the four most common adult chronic disorders. Supporting asthma patients in~     improving their asthma control and symptoms as well as their quality of life are important~     goals in clinical management. This study will test the effect of a widely-available~     mindfulness training program in improving asthma control and symptoms and quality of life~     among patients with asthma, and explore the relationship between asthma control and a number~     of factors, including how well patients perceive their respiratory symptoms.~   "
98683|NCT02275546|"~     The purpose of the study is to assess the performance and safe use of the vaginal ring~     applicator as an optional aid for insertion of a placebo vaginal ring into the vagina in~     healthy women~   "
98684|NCT02275533|"~     This randomized phase II trial studies how well nivolumab works in eliminating any remaining~     cancer cells and preventing cancer from returning in patients with acute myeloid leukemia~     that had a decrease in or disappearance of signs and symptoms of cancer after receiving~     chemotherapy. Monoclonal antibodies, such as nivolumab, may block cancer growth in different~     ways by targeting certain cells.~   "
98685|NCT02275520|"~     The investigators will compare the success rates and time to successful IO access during~     simulated adult resuscitation.~   "
98686|NCT02275507|"~     The purpose of this study is to determine the normal hemoglobin curve during cesarean~     delivery and for the first 24 hours after surgery to aid in the creation of an algorithm to~     detect life-threatening bleeding earlier.~   "
98687|NCT02275494|"~     Leg length discrepancy (LLD) is a complication of THA and may result in patient~     dissatisfaction, gait disorder, greater trochanter pain, low back pain. In the literature,~     LLD is reported to vary widely among studies e.g. 6 to 35 mm. However, the threshold at which~     a LLD is clinically important is still a matter of debate. The aim of this study was to~     determine the influence of non-corrected LLD after THA on patients' reported hip function and~     quality of life. This prospective cohort study was conducted at Sundsvall Teaching Hospital~     in Sweden after it was approved by the regional ethics committee at Umeå University (No.~     07-052M and No. 12-287-32M). Between September 2010 and April 2013, all patients with~     unilateral primary osteoarthritis (OA) treated with THA were considered for inclusion.~     Informed consent was obtained from all patients. Patients with secondary OA, previous spinal,~     pelvic, or lower limb injuries or fractures were excluded.~      The primary outcome measure was the Western Ontario and McMaster Universities Osteoarthritis~     (WOMAC) Index that measures functional outcome (ref). The secondary outcome measure was the~     EQ-5D and visual analogue scale (VAS) scale. Patients were assessed preoperatively and at~     follow-up at 1 year postoperatively. The posterolateral approach was used in all operations.~     LLD was measured on the postoperative x-rays. patients were divided into three groups:~     shortening group where the operated leg was more than 5mm shorter compared with the~     contralateral side, the restoration control group where the operated leg was within 5mm~     shortening and 9mm lengthening compared with the contralateral side, and the lengthening~     group where the operated leg became more than 9mm longer compared with the contralateral~     side.~   "
98688|NCT02275481|"~     This is a randomized, open-label, parallel group, multicenter, outpatient study in COPD~     subjects who are discharged from the hospital due to a COPD exacerbation. Subjects who meet~     the eligibility criteria will be randomized to 1 of 2 treatments: arformoterol tartrate~     inhalation solution (BROVANA) 15 mcg twice daily (BID) or tiotropium bromide (SPIRIVA) 18 mcg~     once daily (QD), each given for 90 days.~   "
98689|NCT02275468|"~     a prospective, multicenter (outpatient clinics of the three participating hospitals in~     Beijing), double blinded and randomized placebo-controlled study.~      The study consisted of a 2-week run-in period and a 12-month treatment period.~   "
98690|NCT02275455|"~     The worldwide prevalence of autism is constantly increasing. People with autisms have~     difficulties in communication and social interaction resulting from atypical perceptual and~     information processing, leading to the accumulation of anxiety. Extreme overloading~     experienced internally may not be visible externally. Identifying stressful situations at an~     early stage may avoid socially problematic behavior from occurring, such as self-injurious~     behavior. Activation of the autonomous nervous system (ANS) is involved in the response to~     anxiety, which can be measured through heart rate variability and skin conductance with the~     use of a portable device, non-intrusively and pain-free. Thus, developing innovative analysis~     of signal perception and reaction is necessary, mainly for the non-communicative individuals~     with autism.~   "
98691|NCT02275442|"~     The link between precarious situations and health conditions are more described in previous~     study. Precarious situations are more frequent and complex especially in rural areas. There~     are recognized like a risk factor of complications during pregnancy and delivery. It's~     necessary to describe antenatal cares for rural women in precarious situations to prevent~     those situations, to understand their difficulties in order to reduce inequalities and health~     spending.~      The aim of the PRUGNANCY study is to understand the difficulties of rural parturient women~     and the strategies developed to overcome them. Recognized earlier precarious situations and~     valorized General Practitioners and restore them to the follow-up or parturient women.~   "
98694|NCT02275403|"~     The purpose of this study is to determine whether the addition of acupuncture to standard~     treatment reduces the level of chemotherapy induced peripheral neuropathy experienced by~     patients with breast cancer or multiple myeloma, during or following treatment with~     neurotoxic chemotherapy.~   "
98695|NCT02275390|"~     The study aims to test the effectiveness of a nurse-led psycho-education program based on~     motivational interviewing technique for Chinese patients with first-onset mental illness over~     a 12-month follow-up. A randomized controlled trial will be conducted with 180 Chinese~     patients with schizophrenia newly referred to one outpatient clinic in Hong Kong. They will~     be randomly assigned to either the eight-session nurse-led psycho-education program or usual~     psychiatric outpatient care (both n=90). The patients' general and mental health, illness~     insight, self-efficacy, services utilization, and hospitalization rates were measured at~     recruitment and one week, six months and 12 months post-intervention.~   "
98696|NCT02275377|"~     This research aims to evaluate the effects of inspiratory muscle training (IMT) on blood~     pressure, in inspiratory muscle mechanoreflex, autonomic cardiovascular control in subjects~     with hypertension.~   "
98697|NCT02275364|"~     The aim of the study is to evaluate the effect of the nasal strip (relative to the placebo~     strip) on the nasal passages using anatomical MRI scans and to demonstrate the effect of the~     strip on breathing correlated cortical activity, using interoceptive fMRI task and analysis~     techniques derived from physiological data collected during scanning.~   "
98698|NCT02275351|"~     The purpose of this study is to characterize the safety, tolerability, and efficacy of~     topical SM04554 solution (0.15% and 0.25%) applied to the scalp of male subjects with~     Androgenetic Alopecia (AGA).~   "
98699|NCT02275338|"~     To assess the efficacy of Lanreotide Autogel 120 mg for the relief of vomiting due to~     inoperable malignant intestinal obstruction in patients without nasogastric tube (NGT) and to~     assess the efficacy of lanreotide Autogel 120 mg on removal of nasogastric tube without the~     recurrence of vomiting in patients with an inoperable malignant intestinal obstruction with a~     nasogastric tube.~   "
98700|NCT02275325|"~     Vestibular schwannoma (VS) is a benign tumour from Schwann cells surrounding the vestibular~     nerve, which slowly grows within the internal auditory canal and then into the~     cerebellopontine angle, leading to a gradual vestibular dysfunction. The slowly progressive~     alteration of vestibular function allows the gradual implementation of central adaptive~     mechanisms called vestibular compensation. The total unilateral vestibular deafferentation~     induced by the surgical tumour removal suddenly leads to a decompensation of this previously~     compensated situation, which explains why most patients report severe vertigo immediately~     after surgery and which is responsible for perturbations of the postural control~     (Parietti-Winkler et al., 2006, 2008, 2010, 2011). Recently, Gauchard et al. (2013) suggested~     that preoperative and regular physical activity would limit the adverse effects of surgical~     removal on balance control. Also, patients benefited faster and better from the postoperative~     vestibular rehabilitation.~      Thus, preoperative vestibular rehabilitation, including physical and balance exercises, could~     help to limit postoperative balance disorders and promote postoperative balance compensation.~     This could lead to a decrease in the duration and cost of the postoperative management and~     faster improvement of quality of life.~   "
98701|NCT02275312|"~     The objective of this study is to evaluate the effectiveness of BoNT-A on functional~     improvement in patients with post-stroke upper and/or lower limb spasticity in the early~     stage of spasticity development, according to routine clinical practice.~   "
98702|NCT02275299|"~     This study is intended to evaluate the efficacy and safety of Iguratimod Plus Methotrexate~     Compared to Leflunomid Plus Methotrexate in patients with active Rheumatoid Arthritis (RA).~   "
98703|NCT02275286|"~     Phase I-II trial that combines trabectedin plus radiotherapy for tumor reduction response~     measure in two cohorts of patients:~      Cohort A: Patients with diagnosis of non-operable or unresectable or not oncologically~     recommended metastasectomy of limited to lung metastases soft tissue sarcoma.~      Cohort B: Patients with locally advanced resectable Myxoid Liposarcoma. Phase I: escalating~     dose of 1.3 or 1.5 mg/m2. Radiotherapy for cohort A: 30Gy in 10 fractions (3Gy/fraction)~     Radiotherapy for cohort B: 45Gy in 25 fractions (1.8Gy/fraction) A translational substudy is~     developed to analyse different biomarkers predictive value.~   "
98704|NCT02275273|"~     The goal of this study is to correlate the pelvic magnetic resonance imagery characteristics~     of adnexal masses with their anatomopathological characteristics.~   "
98705|NCT02275260|"~     The REDUCE-TE Pilot study is an international, multicenter, prospective, single arm study to~     compare the AlCath Flux eXtra Gold ablation catheter regarding the prevention of new~     subclinical cerebral thromboembolic lesions after Pulmonary Vein Isolation to historical data~     from the literature.~   "
98706|NCT02275247|"~     To investigate whether stellate ganglion block is helpful to brain protection during cranial~     aneurysm surgery~   "
98707|NCT02275234|"~     The purpose of this study is to investigate whether simple psychological interventions can be~     implemented at the Essex Cardiothoracic Centre (CTC) with a view to supporting the~     psychological wellbeing of survivors of cardiac arrest during their recovery.~   "
98708|NCT02275221|"~     Using peripheral blood mononuclear cells (PBMC) and serum collection from HBV and HCV~     infected patients in a number of different immunological assays, the investigators hope to~     identify any changes in the number and function of these immune cells and to investigate how~     these changes contribute to viral persistence and disease progression.~   "
98709|NCT02275208|"~     This study is a prospective, multi-center, single-arm study evaluating the SIPS procedure.~     Subjects who meet the eligibility criteria will be considered for study participation and~     will be followed through 12 months.~   "
98710|NCT02275195|"~     Through bio-sampling this study investigates the relationship between the frequency and~     function of the cells of a patients immune system and how these change and impact on the~     outcome of alcoholic hepatitis. the investigators will examine the role of different cells of~     the immune system and how they may determine the outcome of this condition. The investigators~     will also look at how established treatment strategies impact on the frequency and function~     of these cell subsets.~   "
98732|NCT02274909|"~     To compare the influence of a training program with Pilates and PNF methods to elderly women~     on the strength gains and motor control during voluntary contractions~   "
98733|NCT02274896|"~     The study was designed to establish the safety of the Bayston Antimicrobial PD catheter that~     is impregnated with a cocktail of three well known anti-microbials~   "
98734|NCT02274883|"~     This study is intended to evaluate the nutritive effects of study formulas on growth and~     cognitive outcomes.~   "
98711|NCT02275182|"~     Post-Operative Cognition Dysfunction (POCD) is a common complication after surgery, POCD can~     lead to a reduced ability and seriously affect the quality of life of patients, increase~     personal and social burden, POCD may also increase mortality.POCD can occur at any age, but~     the long-term, affect the daily lives of POCD in elderly patients over 60 years of age are~     more prone. Age is a risk factor for advanced or long-term POCD. POCD determined by~     preoperative cognitive function and psychological scales postoperative assessment, the main~     recommendation of the agreed test methods include, Rey auditory verbal test, the connection~     test, digit span test. In this study, preoperative mini-mental state examination (MMSE)~     screening, comprehensive neurological function during hospitalization for memory, attention,~     executive function and exercise capacity test, and telephone follow-up after discharge Scale~     Revised (TICS-M) test.~      Few study showed that dexmedetomidine may improve cognitive function in young patients others~     show that dexmedetomidine did not reduce POCD incidence after 24 hours of surgery. These~     results conflict and it is necessary to carry out large-scale, multi-center, randomized,~     controlled clinical study to determine whether dexmedetomidine reduce the POCD incidence or~     not for elderly patients.~   "
98712|NCT02275169|"~     Aim of the study is to evaluate the effect of highly purified human follicle-stimulating~     hormone treatment on the chance of retrieving testicular sperm (sperm retrieval rate) from~     infertile male patients with non-obstructive azoospermia of unknown origin.~   "
98713|NCT02275156|"~     The primary objective of this study was to evaluate the pharmacokinetics of evolocumab after~     a single 140 mg subcutaneous (SC) dose in adults with normal renal function or severe renal~     impairment or end-stage renal disease (ESRD) receiving hemodialysis.~   "
98714|NCT02275143|"~     Currently patients with certain cancer usually have routine follow up (Computed Tomography of~     Thorax, Abdomen and Pelvis) CT TAP scans to see response to treatment or relapse. The study~     proposal allows the evaluation of the coronary arteries by modifying the current CT TAP~     technique without significant additional procedures, intravenous contrast or radiation - i.e.~     an opportunistic Computed Tomography Coronary Angiogram (CTCA) without any penalty. The~     question is does performing Computed Tomography (CT) of the thorax in such a way confer~     important additional information about cardiac risk? At the same time the investigators need~     to ensure that doing scan as per CTCA protocol produces equivalent image quality to evaluate~     other structures in the chest. A recent small retrospective study has using a similar~     technique suggests that it may in fact improve image quality due to less cardiac related~     motion artefact.~   "
98715|NCT02275130|"~     The voice is an indispensable source of human communication. Current time puts high demands~     on the quality of voice in most professions. Organic or functional changes of vocal cords~     associated with their insufficiency lead to a deterioration of voice quality, voice fatigue,~     hoarseness or breathing difficulties. This has adverse psychological, social and economic~     consequences for the patient, the employer and its surroundings. The injection techniques can~     be performed under general and local anaesthesia. The defined injectable substance is~     inserted directly in the vocal cords, which increases its volume and results in an almost~     immediate improvement of the voice quality. For injection can be used various materials, e.g.~     autologous fat, calcium hydroxyapatite, silicone, and others. Injection techniques are less~     invasive, associated with less perioperative morbidity. Operation can be also performed under~     local anaesthesia in selected patients, therefore is preferred for patients with multiple~     comorbidities and risk of general anaesthesia.~   "
98716|NCT02275117|"~     The purpose of this study is to assess ALD403 in the prevention of migraine headache in~     chronic migraineurs.~   "
98717|NCT02275104|"~     MIGAT will develop and transfer software tools to assist ablation therapy of cardiac~     arrhythmias. The scientific background and objectives of MIGAT differ between atrial and~     ventricular arrhythmias, because the knowledge on structure-function relationships and the~     definition of ablation targets are different.~      Hypothesis: The combination of body surface mapping and imaging will enable a comprehensive~     non-invasive assessment of cardiac arrhythmia mechanisms and localization, myocardial~     structural substrate, and cardiac anatomy, all of which should be of value to better define~     targets for ablation therapy. No software solution is currently available for multimodal data~     processing, fusion, and integration in 3-dimensional mapping systems to assist ablation.~     Because such a development requires a trans-disciplinary approach (cardiac electrophysiology,~     imaging, computer sciences), it is likely to emerge from an academic initiative.~      Objectives: MIGAT will gather resources from the Liryc Institute (L'Institut de Rythmologie~     et Modélisation Cardiaque), the Inria (Institut National de Recherche en Informatique et en~     Automatique) and the University Hospital of Bordeaux to develop a computer-based solution~     with high expected impact on the daily management of cardiac electrical disorders. The~     research program will benefit from the MUSIC (Magnetom Avanto, Siemens, Erlangen, Germany)~     equipment recently funded as part of the Investissement d'Avenir program, and combining~     state-of-the-art electrophysiology and magnetic resonance imaging technology. MIGAT will~     involve software engineers, computer science researchers, cardiologists, radiologists and~     clinical research personnel with the following objectives:~        -  Development of a multimodal data processing software to assist cardiac ablation~        -  Optimization and Validation of the software in terms of user experience~        -  Optimization and Validation of the software in terms of clinical performance~        -  Optimization of software quality compatible with subsequent device certification and~          randomized-controlled evaluation~   "
98718|NCT02275091|"~     Patients with type 1 diabetes type 1 (DM1) have increased risk of death due to heart disease~     and stroke. These cardiovascular conditions (CVD) are the leading cause of death in patients~     with DM1 younger than 40 years of age and up to 35% of all persons with DM1 will die before~     age 55 from CVD. Strategies are needed to help identify adolescents with DM1 at risk for CVD~     so that interventions to prevent heart disease and stroke can be undertaken.~   "
98735|NCT02274870|"~     Continuous femoral nerve blocks (CFNB) provide effective pain control to patients undergoing~     total knee replacement (TKR). However the resulting motor blockade can lead to decreased~     quadriceps muscle strength and delayed functional recovery.The purpose of this study is to~     compare the effect of Liposome Bupivacaine infiltration into the knee to CFNB on pain control~     and functional recovery~   "
98736|NCT02274857|"~     The study is a prospective, multicenter, randomized study to assess the safety and~     effectiveness of FIRM procedures followed by conventional ablation including PVI versus a~     standard PVI procedure for the treatment of persistent atrial fibrillation.~   "
98737|NCT02274844|"~     Medication adherence is especially critical in regions like rural Alabama, where residents~     have among the worst health outcomes in the US. This project was designed in collaboration~     with our community member partners and builds on a 5-year partnership of community-engaged~     research on diabetes peer coaching interventions and our experience with peer storytelling.~     The investigators will test the hypothesis that an intervention designed within the Corbin~     and Strauss framework can improve adherence and health outcomes compared to usual care.~   "
98719|NCT02275078|"~     The purpose of this project is to conduct a pilot study evaluating the feasibility and~     potential benefits of a phone assessment/reporting system (tele-system) in addition to a~     written action plan and nurse case manager support to improve patients' adherence to COPD~     treatment in those at risk for exacerbations.~      Primary objective: explore the potential benefits with respect to patient's adherence, i.e.,~     prompt use of the antibiotic and/or prednisone in the event of an exacerbation, increased~     adherence to maintenance medication; to increase patient's self-efficacy in self-managing~     their disease; and to use more efficiently program resources, i.e., the case-manager.~      Secondary objectives:~      To assess the proportion of patients who effectively self manage exacerbations by using their~     COPD Action Plan~      To assess self management of COPD patients with respect to the increased adherence to regular~     respiratory medication, (SmartInhaler electronic monitoring);~      To assess increased self-efficacy in COPD patients identifying and managing exacerbations~     (baseline vs after 12 months);~      To assess symptoms recovery, health status improvement, and prevention of ER visits and~     hospital admissions for COPD exacerbations.~      To assess the efficiency in using program resources,~      To evaluate the feasibility of this treatment approach and to provide pilot data (needed for~     a larger multi-centre clinical trial;~      To evaluate the feasibility and need of assessment during and after exacerbation onset,~     health-related quality of life and physical activity;~      To evaluate the safety of this approach; this is in terms of the delay in starting prednisone~     and an unfavourable outcome (ER visits and/or hospitalization).~   "
98720|NCT02275065|"~     This study will investigate the short-term antiviral potency, safety, plasma pharmacokinetics~     (PK), and the PK/pharmacodynamic (PD) relationship (the dose-response relationship) of~     GS-9883 at multiple doses in antiretroviral (ART) treatment-naive adult subjects and subjects~     who are ART-experienced but are currently off of ART therapy. Up to 32 participants will be~     enrolled in the study.~   "
98721|NCT02275052|"~     This is a multicenter, randomized, double-blind, placebo-controlled, 2-period, complete block~     design cross-over study.~      The purpose of this study is to evaluate the effect of UMEC/VI 62.5/25 microgram (mcg) on EET~     as measured by the Endurance Shuttle Walk Test (ESWT) compared to placebo. Additionally, the~     effect of UMEC/VI compared to placebo on lung function and lung volumes in COPD patients will~     be characterized.~      Approximately 298 participants will be screened and, assuming 35% of these will not be~     eligible for randomization; approximately 194 participants will be randomized.~      Eligible participants will be randomized 1:1 to one of 2 treatment sequences. In sequence 1~     participants will receive UMEC/VI 62.5/25 mcg in Treatment Period 1 and placebo in Treatment~     Period 2. In sequence 2 participants will receive placebo in Treatment Period 1 and UMEC/VI~     62.5/25 mcg in Treatment Period 2. Treatments will be delivered once-daily via a dry powder~     inhaler (DPI). Each treatment period will be for 12 weeks and will be separated by a wash out~     period of 12-17 days. The total duration of patient participation, including the Follow-Up~     will be approximately 30 weeks. All participants will be provided with albuterol for use on~     an as needed (prn) basis throughout the run-in, washout and study treatment periods while~     on investigational product.~   "
98722|NCT02275039|"~     This phase I trial studies the side effects and recommended dose of the combination of p53MVA~     vaccine (modified vaccinia virus ankara vaccine expressing tumor protein p53 [p53]) and~     gemcitabine hydrochloride in treating patients with ovarian epithelial cancer that has come~     back. Vaccines made from inserting a laboratory-treated gene into a person's tumor cells may~     help the body build an effective immune response to kill tumor cells that express p53. Drugs~     used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the~     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Giving modified vaccinia virus ankara vaccine expressing p53~     together with gemcitabine hydrochloride may work better in treating patients with ovarian~     epithelial cancer.~   "
98723|NCT02275026|"~     The purpose of this study is to understand how elderly individuals regain their cognitive~     skills following general anesthesia. The investigators will compare an age stratified group~     of volunteers who will be evaluated with a series of cognitive tests and a functional MRI.~     The participants will then be administered general anesthesia for two hours. The~     investigators will then assess the participants using state of the art tools to determine~     when participants return to their cognitive baseline.~   "
98724|NCT02275013|"~     To assess the effects on outcome of levosimendan with respect to timing of its administration~     on the postoperative course of high-risk cardiac surgery patients in a retrospective~     observational study.~   "
98725|NCT02275000|"~     The aim of this study is to develop and assess the feasibility of a physiotherapy~     intervention for people with functional motor symptoms (also known as psychogenic~     neurological symptoms and conversion disorder). Participants will be randomised to receive~     the intervention or a treatment as usual control.~   "
98726|NCT02274987|"~     This is a single arm multi-center pilot trial within the Pacific Pediatric Neuro-Oncology~     Consortium (PNOC). The current study will use a new treatment approach based on each~     patient's tumor genomic profiling consisting of whole exome sequencing and RNA sequencing as~     well as predictive modeling.~   "
98727|NCT02274974|"~     Study to compare between efficacy of post-caesarean section infiltration with lidocaine and~     epinephrine versus lidocaine only to reduce post-incisional pain.~   "
98728|NCT02274961|"~     This clinical study hypothesized that S-pantoprazole 10mg would be effective to treat Non~     erosive Reflux Disease than placebo.~   "
98729|NCT02274948|"~     This study expects to evaluate the use of metformin in the management of obese children.~     Insulin resistance among obese Sri Lankan children (south Asian origin) is high, which had~     been shown in the investigators previous work.~      This study will look at the effect of metformin on changes in insulin resistance, fatty liver~     state, body fat content, BMI and other metabolic derangement.~   "
98730|NCT02274935|"~     This study examines the effect of balance and walking exercise on cognition and mobility in~     people with Multiple Sclerosis.~   "
98731|NCT02274922|"~     For a long time, culture was the only way to detect Campylobacter. It appears that rapid~     immunochromatographic tests (ICT) have detected more positive cases compared to culture,~     ELISA and molecular tests. The aim of our study is to evaluate the specificity of the ICT~     which are really interesting tools to use since they allow a diagnosis in about 15 min, in~     comparison to different methods of detection even serology.~   "
98739|NCT02274818|"~     The investigators are conducting a cluster randomized trial in a sample of 63 internal~     medicine (IM) training programs that are randomly assigned to either the current duty hour~     standards or less restricted flexible duty hour standards.~      The trial includes a main protocol in which all randomized IM programs participate and two~     substudies. Time and Motion and Sleep and Alertness, each conducted at a subset of IM~     programs and focusing on more detailed data collection at the intern level.~      The main protocol will examine patient safety and costs as well as quality of education. The~     Time and Motion substudy examines additional educational outcomes. The Sleep and~     Alertness substudy examines intern sleep time and alertness.~   "
98740|NCT02274805|"~     The purpose of the study is to gather tissue (from the neck region), specimens (blood and~     urine) and medical record data from many patients and store them in one place so that~     scientists have the information they need to conduct research and learn about new ways to~     predict, identify and treat illness, specifically those related to obesity and diabetes.~   "
98741|NCT02274792|"~     The purpose of this study is to learn more about the immune response to etanercept produced~     using a modified process in patients with plaque psoriasis.~   "
98742|NCT02274779|"~     There is an increasing number of reports describing the existence of a proportion of prostate~     cancer patients who present with a reduced number of metastases (<5 lesions) at relapse. This~     oligometastatic status has also been recognized in other tumor types such as melanoma, soft~     tissue sarcoma, liver, lung, and breast cancer, and has influenced the management of these~     malignancies in that a more radical treatment such as surgical resection has been employed.~     Positron Emission Tomography-Computed Tomography (PET-CT) studies with tracers such as~     choline or acetate are reliable tools to help with the diagnosis of oligometastatic disease~     after biochemical treatment failure in prostate cancer. An aggressive treatment combining~     androgen depriving therapy (ADT) and and high-dose irradiation to the oligometastatic~     lesions, as detected by PET-CT, may be proposed for these oligometastatic patients. Such a~     treatment strategy may hypothetically succeed to prolong the failure-free interval between~     two consecutive ADT courses, or even cure selected patients with limited metastatic burden.~     In this study the investigators plan to assess biochemical or clinical relapse-free survival~     at 2 years of prostate cancer with 1-5 oligometastases treated concomitantly with high-dose~     conformal Radiation Therapy and LH-RH agonists.~   "
98743|NCT02274766|"~     This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group~     study to evaluate the efficacy and safety of ADS-5102 extended release (ER) capsules, an~     investigational formulation of amantadine, dosed once nightly at bedtime for the treatment of~     levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD). The novel~     pharmacokinetic profile of ADS-5102 is expected to achieve i) maximal concentrations in the~     early morning through mid-day, when LID can be troublesome, and ii) lower concentrations in~     the evening, potentially reducing the negative impact of amantadine on sleep. This~     pharmacokinetic profile could enable higher doses to be tolerated with a once-nightly ER~     formulation than can be tolerated with an immediate-release formulation. The once-nightly~     dosing regimen may also provide enhanced convenience and compliance.~      In a previous clinical study, ADS-5102 met its primary endpoint; LID was significantly~     reduced as measured by the change in UDysRS score over 8 weeks vs. placebo.~   "
98744|NCT02274753|"~     Colorectal cancers are the leading cancers for both sexes combined. They represent 15-20% of~     all cancers. This cancer has a severe prognosis, the survival rate at 5 years is around 55%~     and in France it is estimated, all colorectal cancers are responsible for an annual mortality~     of 15,000 patients. The prognosis of colon cancer knows no significant improvement.~      The treatment of colon cancer is surgical. It is intended for removal of colonic segment~     bearing the tumor with margins of healthy colon. The therapeutic attitude following the~     surgery is essentially driven by histopathology of the tumor. Adjuvant chemotherapy for all~     patients with localized stage II provides no benefit because the effectiveness of~     chemotherapy is limited and vulnerable to systemic toxicity. However, nearly 30% of patients~     with stage II disease will have a recurrence / metastasis. These patients could benefit from~     adjuvant chemotherapy.~      Intense research efforts have been made to identify markers predictive of relapse. Over~     thirty biological markers (eg. Mutations, deletions, chromosomal instability, ...) were~     highlighted. None of them has so far sufficient prognostic value (independent of TNM) to~     justify routine application in clinical practice in order to adapt the treatment of patients.~      The identification of new prognostic markers is a major issue for colorectal cancer. We~     showed that the intratumoral density memory T lymphocytes (CD45RO) and cytotoxic (CD8)~     strongly influenced the clinical outcome of patients. We have developed and validated a~     immunoscore technique intratumoral immune quantification and creates a platform to~     facilitate the clinical immuno transfer.~      We are currently conducting a large international retrospective study (22 centers,> 9000~     patients) with promotion of cancer immunotherapy Company (SITC) to validate the method~     immunoscore. At the same time, we are conducting a prospective multicenter study ImmuCol~     (National PHRC) to validate the prognostic value of immunoscore in colorectal cancer stage~     I-IV. The goal of inclusion has been achieved, as 420 patients were included for 18 months.~     Clinical follow-up will be 3 years after surgery.~      The program ImmuCol2 research takes advantage of the ImmuCol study to extend the~     investigation beyond the immunoscore to define the combination of interest, prognostic and~     theranostic parameters at diagnosis and during the clinical course patients with an objective~     of personalized medicine.~   "
98745|NCT02274740|"~     Primary Objective:~      To evaluate the ability of lixisenatide to modulate postprandial hyperlipidemia in~     particular, the effects on plasma changes in triglycerides.~      Secondary Objectives:~      The effect of lixisenatide on the following postprandial lipids: apolipoprotein (APO) B48;~     free fatty acid, lipoprotein distribution, cholesterol, and low-density lipoprotein (LDL)~     oxidation.~      The effect of lixisenatide on chronic low-grade inflammation present in non-insulin dependent~     diabetes mellitus (NIDDM) and obesity.~      The effect of lixisenatide on microvascular dysfunction. To evaluate the effect of~     lixisenatide on postprandial plasma glucose, insulin and C-peptide and glucagon.~   "
98746|NCT02274727|"~     The three-year cumulative risk of a recurrent stroke, dependent on aetiology, is up to 25 per~     cent. At present, preventing recurrence relies on a broad approach to reduce risk factors~     associated with atherosclerosis, heart disease and metabolic disorders. However, more~     specific interventions, such as anticoagulation and surgery or stenting, need aetiologic~     information. BIOSIGNAL aims to determine where the most promising biomarkers can help~     identify stroke aetiology and also predict recurrent stroke. In addition, the insights gained~     into the processes underlying different stroke subtypes may lead to more targeted diagnostic~     tools.~   "
98747|NCT02274714|"~     This case-control study will screen for dysmenorrhea and assess severity of menstrual~     symptoms in menstruating women with CD and UC compared with healthy age-matched controls. IBD~     activity will be characterized using previously validated clinical disease activity indices.~     General and health-related quality of life will be assessed using validated measures.~   "
98748|NCT02274701|"~     This study evaluates the impact of holistic needs assessment (HNA) on patient/clinician~     communication in outpatient cancer care. Half of the participants will complete a HNA prior~     to their clinical consultation. They will then take it into the consultation and it will~     inform a discussion around any identified areas of need. Half of the participants will be in~     the control group meaning there will be no additional intervention they will receive care as~     normal. The consultations will be audio-recorded. The patient will complete two outcome~     measures following the consultation.~   "
98749|NCT02274688|"~     The nation's trauma care system, which includes trauma center hospitals & emergency~     departments, is where over 30 million Americans receive care after traumatic injuries each~     year. Injury victims are diverse patients who suffer from complications of the initial injury~     as well as from multiple complex medical & mental health conditions. Currently, high-quality~     patient-centered care is not the standard of care throughout US trauma care systems. Injured~     trauma survivors treated in trauma care systems frequently receive fragmented care that is~     not coordinated across hospital, emergency department, outpatient, & community settings.~     Post-injury care is frequently not individualized to integrate the patient's most pressing~     post-traumatic concerns & preferences into medical decision making. The investigators, as a~     group of front-line trauma center providers, patients, researchers & policy makers, have been~     working together for over a decade to integrate patient-centered care into US trauma care~     systems. The investigators began this work by asking groups of injured patients the key~     patient-centered question: Of everything that has happened to you since your injury, what~     concerns you the most? The investigators developed scientifically sound assessment tools~     that allowed us to follow patient concerns after injury hospitalization. In May of 2011, the~     investigators convened an American College of Surgeons' policy summit that addressed mental~     health & patient-centered care integration across US trauma care systems. As part of this~     policy summit, patient members of our team presented their experiences of traumatic injury &~     recovery. While giving injured patients a voice at the summit, these narratives did not~     move surgical policy makers to develop mandates or guidelines for patient-centered care. In~     contrast, presentations that included information from randomized comparative effectiveness~     trials & standardized outcome assessments convinced surgical policy makers to develop US~     trauma care system policy mandates & best practice guidelines for post-traumatic stress~     disorder & alcohol use problems. Our team now realizes that in order to optimally integrate~     patient-centered care into US trauma care systems, the investigators must use the best~     scientific methods that capture the highest-quality data. This PCORI proposal aims to~     demonstrate that a patient-centered care management treatment that addresses patient's~     post-injury concerns & integrates patient concerns & preferences into medical decision~     making, while also coordinating care, can improve outcomes of great importance to patients &~     their caregivers, front-line providers & policy makers. This proposal directly addresses two~     PCORI patient-centered research questions: After a traumatic injury, what can I do to~     improve the outcomes that are most important to me? & How can front-line providers working~     in trauma care systems help me make the best decisions about my post-injury health & health~     care?~   "
98750|NCT02274675|"~     A pilot study to assess the effectiveness of CR2-Haptic and determine the feasibility of~     including robotic therapy into the daily rehabilitation program.~   "
98751|NCT02274662|"~     The primary purpose is to provide access of thymus tissue transplantation to patients who~     have immunodeficiency, hematologic malignancies, or severe autoimmune disease related to poor~     thymic function. With no thymus function, bone marrow stem cells do not develop into T cells,~     which fight infection.~      Eligible participants undergo thymus transplantation and biopsy. Immune suppression may be~     given depending on the immune status and clinical condition of the participant. Immune~     function testing is continued for one year post-transplantation.~   "
98752|NCT02274649|"~     The research will examine the effects of enhanced peer mentor interactions on facilitating a~     successful transition to community living following traumatic spinal cord injury.~     Participants in the research will be assigned to either (1) the control group that will~     receive traditional peer mentor types of interactions or (2) to the intervention group that~     will receive an enhanced peer mentor program called the One-on-One Initiative. Assignment to~     one of these two groups will occur randomly on admission to Shepherd Center; the only~     stratifying criteria is injury level - C6 and above vs. C7 and below.~   "
98753|NCT02274636|"~     This research study is a randomized, controlled study developed to test how well a dry mouth~     product that contains xylitol affects some of the symptoms of gastroesophageal reflux disease~     (GERD. Individuals who experience symptoms of gastro esophageal reflux disease (GERD) and who~     are accepted into the study will be asked to report on the frequency and severity of several~     symptoms specific to the condition that occur during sleep. The study is composed of two~     phases:~      Phase one involves collection of baseline information for two weeks. Phase two is the~     intervention phase of the study. In this phase of the study, each subject will be randomly~     assigned (like flipping a coin) to use either the product of interest or a different dry~     mouth product for two weeks.~   "
98754|NCT02274623|"~     This is an open-label exploratory study of CTAP101 Capsules in patients with bone metastases~     arising from either breast or prostate cancer, who are taking anti-resorptive therapy.~   "
98755|NCT02274610|"~     Evaluation of the pharmacokinetic equivalence of two Docetaxel formulations in terms of AUC~     and Cmax~   "
98756|NCT02274597|"~     The aim of this study is to assess the impact of different environmental factors on the~     ability for a thermistor-based epitympanic thermometer to accurately read the temperature of~     a normothermic individual and thereby estimate their feasibility and reliability in the~     austere pre-hospital setting.~   "
98757|NCT02274584|"~     Currently, a majority of lymphomas cannot be cured by standard chemo-radiotherapy. Cluster of~     differentiation antigen 30 (CD30) is expressed in many lymphoma subtypes, such as Hodgkin~     lymphoma (HL) and anaplastic large cell lymphoma (ALCL). CD30 represents a very attractive~     target for chimeric antigen receptor (CAR)-based immune cell therapy. This study will~     evaluate a novel 4th generation CD30 CAR engineered with a self-withdrawal mechanism~     (FKBP-iCasp9) for both efficacy and safety evaluation in lymphoma patients.~   "
98758|NCT02274571|"~     The purpose of this study is to find out if a novel drug approved by the Food and Drug~     Administration [Duavee™, Pfizer, Inc] for treatment of postmenopausal symptoms (vaginal~     dryness and hot flashes) and prevention of osteoporosis also improves insulin sensitivity by~     decreasing body fat especially in your liver.~      DUAVEE™ (Conjugated Estrogens/Bazedoxifene) is a new prescription medicine that contains a~     mixture of estrogen (the main female hormone made by the ovaries) and bazedoxifene, which is~     FDA approved. For over 60 years, estrogens have been used as hormonal treatments to help~     manage hot flashes and help prevent postmenopausal bone loss. But in the treatment of~     postmenopausal women, the use of estrogens alone can increase the risk of developing cancer~     of the uterus. So estrogens have been traditionally paired with a progestin to decrease the~     risk of hyperplasia (the thickening of the lining of the uterus), which can be a precursor to~     cancer. DUAVEE™ uses bazedoxifene, a selective estrogen receptor modulator (SERM), in place~     of a progestin to help protect the uterus against thickening of the uterus that may result~     from estrogens alone.~      In this study, you will get either DUAVEE™ or the placebo (a dummy pill that may look like~     medicine but contains no active medication) first and then switch to the other pill.~   "
98759|NCT02274558|"~     The purpose of this study is to evaluate the efficacy, safety, and tolerability of NBI-98854~     administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.~   "
98761|NCT02274532|"~     A study to investigate the hypothesis that a Pisa/IIT Robotic SoftHand Pro converted to a~     prosthetic terminal device will enhance the performance of people with limb loss in a wider~     range of daily living tasks than allowed by today's commercially available prosthetic hands,~     and will exceed established benchmarks for activities of daily living (ADL).~   "
98762|NCT02274519|"~     Does Tai Chi Easy (TCEasy), a simple and repetitive form of exercise that consists of~     movements with meditation, improve quality of life in those afflicted with multiple myeloma~     undergoing autologous stem cell transplantation?~   "
98763|NCT02274506|"~     The goal of this clinical research study is to learn if researchers can successfully and~     safely give patients who have had a stem cell transplant an infusion of white blood cells~     (called T-cells) that have been collected from an unrelated person, and that have been~     genetically changed. The process of changing the DNA (genetic material) of these T-cells is~     called gene transfer. The gene transfer involves drawing blood from an unrelated donor,~     separating out T cells using a machine, changing the cells' DNA in the laboratory, and~     returning the genetically changed cells back to the body. T-cells are a type of white blood~     cell that fight infection. The type of gene transfer being used in this study is designed to~     help your T-cells to better fight cancer by targeting a chemical marker that is found on~     certain cancer cells.~      Researchers want to learn if these genetically-changed T-cells can help to control B-cell~     leukemia or lymphoma after a stem cell transplant.~      Researchers want to find out the highest tolerable dose of these T-cells that can be given to~     patients with relapsed leukemia or lymphoma.~   "
98764|NCT02274493|"~     The goal of this clinical research study is to learn more about the safety and feasibility of~     using the Da Vinci Robotic Surgical system in procedures that harvest the latissimus dorsi~     muscle (a back muscle below your shoulder) for reconstructive procedures.~   "
98765|NCT02274480|"~     The goal of this study is to see if a special type of heart scan called a diffusion weighted~     magnetic resonance imaging (DW-MRI) that uses extra measurements, can be used to find early~     signs of heart damage from chemotherapy.~   "
98766|NCT02274467|"~     Lumbar epidural analgesia is commonly used for labor pain relief due to its effectiveness and~     safety. Despite its very high success rate, the epidural technique remains a rather blind~     technique and failures continue to occur. The correct placement of an epidural catheter,~     however, remains a clinical problem, since there is no imaging technique that could be used~     at the bedside to determine the exact positioning of the catheter. The technique of a~     trans-catheter electric stimulation test (TCEST) has been successfully used to detect the~     proper epidural catheter location for pediatric, post-operative and laboring obstetric~     patients. The response to the TCEST with the uniport (single hole) epidural catheters has~     been well described. There is a growing body of evidence that multiport epidural catheters~     provide an advantage to uniport catheters, since additional ports likely allow for an~     enhanced distribution of the local anesthetic solution. This was shown to result in a lower~     incidence of inadequate analgesia, including unilateral sensory blockade and missed sensory~     segments. The characteristics of the TCEST response using a multiport catheter remain to be~     determined. The aim of this study is to compare the response patterns to the TCEST using a~     single port versus multiport wire reinforced epidural catheters. The hypothesis of this study~     is that the incidence of a bilateral response to the TCEST will be higher in the multiport~     catheter as compared to the uniport catheter.~   "
98767|NCT02274454|"~     Postpartum hemorrhage (PPH) is a leading cause of maternal morbidity and mortality worldwide~     and is caused most commonly by poor uterine muscle tone after delivery. The first line agent~     used in the prevention and treatment of PPH is oxytocin, which acts by binding with the~     oxytocin receptor (OTR) found on myometrial cells to cause uterine contraction. It does this~     by increasing levels of calcium within the myometrial cell, which promotes contraction. Women~     who require augmentation of labor with intravenous oxytocin because of inadequate labor~     progression have been shown to be at increased risk of PPH. In-vitro human myometrial models~     have shown that following prolonged exposure to oxytocin there is desensitization of the~     myometrium resulting in a significant reduction in contractility upon delivery of further~     oxytocin.~      Optimal levels of calcium are very important for contraction of the uterine muscle. Too~     little calcium results in a reduced contraction. Too much calcium may result in either~     stronger contractions, or even possibly relaxation of the muscle and therefore a reduced~     contraction. The investigators currently do not know the effects of calcium on the~     desensitized uterine muscle.~      The investigators hypothesize that myometrial contractility following desensitization of the~     myometrium would be reduced in myometrial samples exposed to low calcium, when compared to~     normal calcium or high calcium exposure. These results will help in establishing whether~     myometrial contraction can be augmented by increasing calcium levels within the body, or by~     optimizing normal physiological calcium levels, in the setting of a augmented prolonged~     labor, which is at higher risk of poor uterine contraction and PPH.~   "
98768|NCT02274441|"~     There is no large-scale data in France or internationally, on the quality of care in~     gynecological emergencies, or the consequences of delay or misdiagnosis of women's health or~     on determinants of these delays or misdiagnosis. The creation of a sentinel network for~     gynecological emergencies could help quantify these links and test strategies to avoid the~     worst effects by implementing simple diagnostic tools from clinical research.~      The network will be designed to promote research in women's health and the emergency~     reception by focusing on:~      (i) Assessment of the quality and organization of care and professional practice for the~     management of gynecological emergencies.~      (ii) The study of severe morbidity and its determinants (iii) comparison of organizational~     practices and health outcomes of women over time within the same department or between~     services having substantially the same recruitment (iv) Comparison of organization systems~     gynecological emergencies departement between different high resource francophone countries~     (France, Switzerland, Belgium).~      (v) The assessment of new diagnostic strategies (sorting or diagnostic aid) or therapeutic~     derived from clinical research.~   "
98769|NCT02274428|"~     Phase 1 clinical trial for the safety and dose determination of Pneumostem (human umbilical~     cord blood derived mesenchymal stem cells) in the premature infants with intraventricular~     hemorrhage (IVH, grade 3-4)~   "
98770|NCT02274415|"~     Streptococcus pneumoniae is the major cause of bacterial infection in patients with sickle~     cells disease.~      The 23-valent pneumococcal polysaccharide vaccine (PSV) is supposed to be poorly immunogenic~     in these patients. We want to evaluate whether a prime with a 13-valent pneumococcal~     conjugate vaccine (PCV), able to induce immunologic memory, would improve the immune response~     against SP polysaccharides (SPP).~      Primary objective: To evaluate and compare the specific antibody response to a prime-boost~     vaccine strategy combining PCV prime at W0 followed by the administration of PSV boost at W4,~     to the administration of PSV alone at W4 in patients with sickle cells disease.~      Secondary objectives: Evaluation and comparison of the specific antibody response to the~     thirteen pneumococcal serotypes shared by the PCV and PSV vaccines, 4 weeks after the single~     PSV vaccination for patients from Group 1 or 4 weeks after the boost PSV vaccination for~     patients from group 2. Evaluation of the duration of the specific antibody response at W24~     and 96. Evaluation of the T CD4 lymphocyte response to the CRM 197 protein. Safety of the~     vaccines.~      Study Design: Randomised, monocentric, controlled phase II study of the immunological~     efficacy of a prime boost strategy combining the sequential administration of the PCV and~     PSV, compared to the administration of the PSV alone. 180 adults patients with sickle cells~     disease will be included. The primary endpoint : proportion of responders at W8 to at least~     10 of thirteen serotypes. Secondary endpoints : Proportion of responders at W8 according to 4~     categories of responders: 5-7; 3-4; 2-1 and 0. Evaluation of the pneumococcal~     opsonophagocytic activity (OPA) at baseline and W8 for each serotype, defined as the~     proportion of patients with OPA > 1:8 geometric mean of the specific antibody titers~     proportion of patients who experienced an increase of specific antibody levels 1 g/ml.~     Evaluation of the priming effect of the PCV vaccine in the group 1. Duration of the specific~     antibody responses at week 24 and W96. CD4 T lymphocyte responses to the CRM 197 protein~     (proliferative and cytokine production) at weeks 0, 8 and 12. Safety of the vaccines~     frequency of Streptococcus pneumoniae infections.~      Statistical Considerations: With a sample size of 180 patients, and a randomization ration of~     1:1, the study will have a power of at least 90% to show a difference of 25% category between~     the group receiving PCV and PSV vs the group receiving PSV alone (two-sided type I error =~     5%). The primary comparison between both groups will be performed using a Chi2 test for~     independent groups or a Fisher exact test where appropriate.~   "
98771|NCT02274402|"~     This is a monocentric study, in the Internal Medicine Service of Cochin Hospital, Paris. Our~     main objective is to determine the pharmacokinetic properties of prednisone, secondary~     objectives are to determine the covariates affecting the prednisone pharmacokinetics and the~     relationship between glucocorticoid exposition levels and their side effects. The~     investigators will use a prospective, observational, population pharmacokinetic approach. 100~     patients starting a prednisone treatment >7,5mg/d for an expected period >3 months will be~     recruited and followed over 6 months.~   "
98772|NCT02274389|"~     The purpose of this study is to describe the medical indication and utilization of expert~     medical consultation among participants treated with bedaquiline (BDQ), BDQ susceptibility~     based on minimum inhibitory concentrations (MICs) reported for baseline and subsequent~     isolates, BDQ drug utilization data to include dose, duration, past treatment history, past~     medical history, concomitant medications, and health care site of treatment, drug~     distribution mechanisms used in the administration of BDQ, patient outcomes (clinical and~     microbiologic) and adverse events among BDQ-treated participants, including deaths.~   "
98773|NCT02274376|"~     This observational study will collect prospective data on the safety and tolerability of~     Xeloda in patients with advanced gastric cancer from every day clinical practice.~     Documentation of treatment for each patient is to continue until the end of treatment per~     oncologist's assessment.~   "
98774|NCT02274363|"~     The purpose of this study is to assess the severity of plaque‐type psoriasis (common~     genetically determined, chronic, inflammatory skin disease characterized by rounded~     erythematous, dry, scaling patches. The lesions have a predilection for nails, scalp,~     genitalia, extensor surfaces, and the lumbosacral region) in brazilian participants with~     chronic plaque-type psoriasis.~   "
98775|NCT02274350|"~     The aim of this study is:~        -  To investigate which sexual side effects occur after external beam radiation therapy and~          brachie therapy~        -  To investigate how many patients are affected~        -  To investigate if there is a time dependency for the severity of the sexual side effects~        -  To investigate if there is a dose dependency for the severity of the sexual side effects~        -  To find predicting and associated factors for the discovered sexual side effects to help~          identifying patients at risk~   "
98776|NCT02274337|"~     AC0010 Maleate Capsules is a new, irreversible, Epidermal Growth Factor Receptor (EGFR)~     mutation selective Tyrosine Kinase Inhibitor.Aim at local advanced or metastatic non-small~     cell lung cancer patients with EGFR mutation or T790M drug-resistant mutation. The molecular~     mechanism: by irreversible combining the EGFR-RTKs ATP binding site of cell, selectively~     suppress the activities of EGFR tyrosine kinase phosphorylation, block the sigal signal~     transduction system of EGFR, and close the function of ras/raf/MAPK downstream. at last block~     the tumor cell growth by EGFR induction, and promotes apoptosis. AC0010 Maleate Capsules has~     three characters: 1. Irreversible combination with EGFR; 2.Efficient suppress the EGFR mutant~     tumor cell and has no suppression to EGFR wild-type cell; 3. Efficient suppress the EGFR~     T790M drug-resistant mutation tumor cell.~   "
98777|NCT02274324|"~     To evaluate the role of dietary modifications of 3 different diets on clinical outcomes in~     patients with PD treated with Duodopa®. This is in search for an optimal diet that will~     accompany Duodopa® treatment and will optimize effect on fluctuations and dyskinesias and~     thus improve motor function and quality of life.~   "
98778|NCT02274311|"~     To assess the impact of clomiphene citrate on serum insulin like growth factor 1 and~     testosterone levels in male acromegalic patients not controlled by surgery, radiotherapy~     and/or medical treatments (somatostatin analogues, dopamine agonists and/or growth hormone~     receptor antagonist)~   "
98779|NCT02274298|"~     This pragmatic cluster randomized controlled trial will test the impact of feedback and a~     toolkit aimed at improving the management of chronic kidney disease (CKD) in the primary care~     setting. This trial will use family physicians in Ontario participating in the Electronic.~   "
98780|NCT02274285|"~     Primary objective:~        -  To demonstrate the non-inferiority in terms of seroprotection rates (Hib antigen (PRP),~          Diphtheria, Tetanus, and Pertussis antigens (PT and FHA), and polio types 1, 2 and 3~          antigens) of investigational arm (Group A: DTaP-IPV/Hib) versus control arm (Group B:~          DTaP-IPV and Hib vaccines administered at separate sites), one month after the primary~          vaccination (all antigens).~      Secondary objectives:~        -  To describe immune responses against all vaccine antigens with no pre-specified~          hypothesis, and at all time points (pre-dose 1, post-dose 3, pre-dose 4 and post-dose 4)~          in the two study groups (Group A and Group B).~        -  To describe the safety after each dose of each vaccine in the two study groups (Group A~          and Group B).~        -  To describe immune responses against all vaccine antigens with no pre-specified~          hypothesis, and at all time points (pre-dose 1, post-dose 3, pre-dose 4 and post-dose 4~          (Group C)~   "
98781|NCT02274272|"~     The purpose of this study is to evaluate the efficacy and safety of probiotics ADR-1/GMNL-263~     capsules (Lactobacillus reuteri ADR-1/ Lactobacillus reuteri GMNL-263) for the treatment of~     adults with type2 DM.~   "
98783|NCT02274246|"~     The purpose of this study is to validate the technique for the detection of left atrial~     fibrosis through segmentation of endocardial and epicardium landmarks of the images obtained~     with 3 Tgadobutrol-enhanced magnetic resonance with the software GIMIAS® in a cohort of~     healthy volunteers, without atrial fibrillation or known cardiovascular risk factors.~   "
98784|NCT02274233|"~     The purpose of this study is to assess safety and amount of the study drug in the blood after~     increasing doses of SP-420. The study will be conducted in patients with β-thalassemia.~   "
98785|NCT02274220|"~     The purpose of this randomized trial is to clarify the role of enteral nutrition (EN) on the~     relationship between cardiopulmonary bypass-induced inflammation and insulin resistance by~     investigating the effects of two different feeding strategies in infants following cardiac~     surgery. The study's primary objective is to determine if early and higher volume feeding~     modifies the relationship between the severity of postoperative systemic inflammation and~     insulin resistance.~   "
98786|NCT02274207|"~     The purpose of this study is to test therapeutic benefits of silver dressing compared with~     non-silver dressing in NPWT(Negative pressure wound therapy). Silver dressing may~     antibacterial effect on infected diabetes mellitus foot.~   "
98787|NCT02274194|"~     The obstructive sleep apnea (OSA) affects between 10% to 25% of the adults. Continuous~     positive airway pressure (CPAP) is the first choice of treatment in severe OSA. However, the~     adherence to CPAP varies, and the interface between patient and the CPAP may interfere with~     adherence, comfort and efficiency as well as in sleep variables. Objectives: (1) to determine~     if self-reported airflow route (nasal or oronasal airflow) is the same as the route~     determined in a laboratory analysis in controls (healthy subjects) and severe OSA patients~     with nasal free airflow of obstruction during asleep and awake, (2) to compare the effects of~     nasal and oronasal CPAP titration (randomized order of masks, 14 days apart) on~     apnoea-hypopnoea index, CPAP level, PSG variables - including analysis for body positioning,~     the airway defense mechanisms (nasal mucociliary clearance, mucus properties, citology and~     inflammation in nasal lavage fluid) and systemic effects (serum miRNA expression and~     cytokines), (3) CPAP adherence after 1 month and 12 months.~   "
98788|NCT02274181|"~     The purpose of this study is to investigate the route(s) of elimination and mass balance of~     enclomiphene after oral administration of a single 25 mg (approximately equivalent to [(~])~     500 nanocurie [nCi]) dose of [14C]Androxal in healthy adult male subjects.~   "
98789|NCT02274168|"~     With the increasing use of implantable cardioverter defibrillators (ICD) for primary~     prevention in patients with structural heart disease, an increasing number of patients are~     expected to develop their first episode of monomorphic ventricular tachycardia (VT) after an~     ICD is in place and the only documentation of the clinical arrhythmia will be the ICD~     electrogram (EG). The absence of a 12-lead ECG in patients with an ICD and sustained~     monomorphic VT represents a limitation when performing treatment with radiofrequency (RF)~     ablation. The analysis of ICD-EG during a RF ablation procedure is expected to provide a~     reference model of VT with clinical expression consisting of the electrical signal of the~     ICD during VT (which otherwise is not generally possible to obtain in ICD patients). This~     will allow for a more targeted approach to the substrate of the VT with clinical expression~     because: 1) if VT is induced by programmed stimulation, one can tell whether it is with~     clinical expression or not, and 2) if VT is not induced, ventricular pacing could be~     performed based on the comparative analysis of morphology and activation times of ICD-EG.~     These approaches will result in improved outcomes of the ablation procedure.~   "
98790|NCT02274155|"~     The purpose of this study is to test the safety of the anti-OX40 antibody, MEDI6469, given~     prior to surgery in patients with advanced head and neck squamous cell carcinoma.~   "
98791|NCT02274142|"~     The aim of this protocol is to evaluate the cost-efficacy of different glass ionomer cements~     in Atraumatic Restorative Treatment restorations, with different handling characteristics:~     powder-liquid versus encapsulated.~   "
98792|NCT02274129|"~     This study investigates the use of a new healing cap which, through altered design and choice~     of material, has been improved when it comes to minimizing the risk of it falling off as well~     as increasing patient comfort.~   "
98793|NCT02274116|"~     The purpose of this study is to determine how the nervous system controlling leg muscles is~     altered following spinal cord injury and how they may be affected by brief periods of low~     oxygen inhalation over time.~      The investigators hypothesize:~        -  Acute intermittent hypoxia (AIH) exposure will increase maximum voluntary leg strength~          in persons with incomplete cervical spinal cord injury (SCI)~        -  AIH exposure will increase multijoint reflex excitability of leg muscles in persons with~          incomplete cervical SCI~        -  AIH exposure will increase walking performance in persons with incomplete cervical SCI~   "
98794|NCT02274103|"~     Compared family-based skills training (aka, Behavioral Family Systems Therapy) to youth with~     poorly controlled type 1 diabetes and their parents either face-to-face or over SkypeTM.~     Examined the differential impact on the youth's adherence to the diabetes medical regimen and~     the youth's blood sugar control.~   "
98795|NCT02274090|"~     This study evaluates the efficacy of 1% Metformin gel in treatment of moderate and severe~     periodontitis subject.~   "
98796|NCT02274077|"~     The aim of this study is to evaluate the short-term postoperative outcomes in the abdominal~     wall reconstruction population using an intraoperative local anesthetic infusion. A~     prospective randomized double blind study of patients undergoing component separation will be~     performed in order to assess the following outcomes:~        1. Length of Stay (LOS)~        2. Return of bowel function~        3. Narcotic pain medication requirements~        4. Nausea and emesis~        5. Pain scores~   "
98797|NCT02274064|"~     This study develops a motivational interview and implementation intention intervention for~     blood donor retention and tests the efficacy of this new approach among first-time, Group O~     donors.~   "
98812|NCT02273869|"~     Our infertility unit has started a clinic for women with rheumatological diseases. those~     women are prone to infertility problems and it might be due to their illness or cytotoxic~     treatment . In our study we are going to observe the effect of their disease on ovarian~     reserve. we will assess it by using intravaginal sonography and blood test such as hormonal~     profile and anti-mullerian hormone (AMH).~   "
98798|NCT02274051|"~     This is a study of kinetin, a nutritional supplement that corrects the mRNA splicing defect~     in patients with familial dysautonomia (FD, also known as Riley Day syndrome or hereditary~     sensory and autonomic neuropathy type III). FD is a rare fatal autosomal recessive disease in~     which the growth and development of selective neuronal populations is impaired. The disease~     is the result of a point mutation in the gene sequence that encodes for kinase complex~     associated protein (IKAP) in chromosome 9q31. The mutation, at the start of the non-encoding~     intron 20, weakens the splice site, causing the spliceosome to wrongly join together exons 19~     and 21 when transcribing the mRNA strand and miss out exon 20. The mutated mRNA produces a~     short unstable IKAP protein that is quickly degraded. Interestingly, the mutation does not~     lead to a complete loss of function. Instead, it results in a tissue specific deficiency in~     splicing efficiency with both normal (wild type) and mutant IKAP mRNA being expressed in~     different ratios in different tissues. Some cells, like fibroblasts, produce mostly normal~     mRNA and protein, where as others, like neurons, produce mostly mutant mRNA and almost no~     functional protein product.~   "
98799|NCT02274038|"~     The investigators will test the hypothesis that positron emission tomography (PET) imaging~     with the imaging agent 18F-thymidine (FLT) can rapidly assess treatment response in patients~     with unresectable non-small cell lung cancer (NSCLC).~   "
98800|NCT02274025|"~     NovellusDx technology identifies tumor-specific driver mutations, but unlike sequencing-based~     tests, NovellusDx has a functional assay that detects dis-regulated translocation of mutated~     signaling proteins to the nucleus. This allows NovellusDx to identify functionally-impactful~     driver mutations regardless of whether the mutation has previously been described or linked~     to a tumor type.~   "
98801|NCT02274012|"~     The investigators are doing this research program to find out if the investigational drug,~     afatinib which is a medication known to block the function of the ErbB2 protein might help~     standard chemotherapy, in particular paclitaxel, work better.~      Afatinib (GILOTRIF) is a highly potent, irreversible inhibitor of the EGFR and HER2. On July~     12, 2013 the United States Food and Drug Administration (US FDA) approved afatinib for the~     first-line treatment of patients with metastatic non-small cell lung cancer whose tumors had~     specific EGFR gene mutations (exon 19 deletions or exon 21 i.e. L858R substitution mutations)~     as detected by an FDA approved test.~      Paclitaxel is a standard, anti-cancer medicine that has been approved by the US Food and Drug~     Administration (FDA) for the treatment of lung cancer.~      The combination of Afatinib and Paclitaxel are considered investigational when used in this~     research program. An investigational drug is a drug that is not approved by the FDA for its~     indication.~   "
98802|NCT02273999|"~     This randomized clinical trial was designed to assess the clinical efficacy of Pulsed~     electromagnetic field PEMF delivered with a wearable device in terms of postoperative pain~     and quality of healing after mandibular third molar extraction.~      The sample included 120 patients undergoing unilateral mandibular third molar extraction. The~     devices were positioned over the area corresponding to the extraction site and wearers were~     asked to keep them in place for 7 days. All patients were asked to record pain (on a visual~     analog scale [VAS]), hours of wearing the device (groups T and P), and any use of analgesics.~     At 7 days, healing complications (dehiscence, tumefaction, pus, local lymphadenopathy, pain~     on palpation, postoperative bleeding, alveolitis) were recorded blindly.~   "
98803|NCT02273986|"~     The purpose of this study is to assess the effects of K-877 on the pharmacokinetics of~     digoxin in healthy adult volunteers.~   "
98804|NCT02273973|"~     This is a two-arm, randomized, double-blind, multicenter, pre-operative study to evaluate the~     effect of combining letrozole and GDC-0032 (also known as taselisib) versus letrozole and~     placebo in postmenopausal women with estrogen receptor-positive (ER+)/human epidermal growth~     factor receptor 2 (HER2) untreated, Stage I-III operable breast cancer. Participants will be~     randomized into one of the two treatment arms with a 1:1 randomization ratio. Letrozole at~     2.5 milligrams (mg) will be dosed once daily plus either Taselisib at 4 mg (two 2-mg tablets)~     or placebo on a 5 days-on/ 2 days-off schedule for a total of 16 weeks.~   "
98805|NCT02273960|"~     The purpose of this study is to assess the safety and tolerability of BMS-986004 when~     administered in subjects with ITP.~   "
98806|NCT02273947|"~     The purpose of this study is to assess the impact of a light meal, a standard meal, and a~     high fat meal on the PK of BMS-955176 MC tablet at a dose of 180 mg, relative to fasted~     conditions.~   "
98807|NCT02273934|"~     The purpose of this study is to determine whether a special kind of rehabilitation offered to~     home-dwelling adults is effective with regards to functional ability, health-related quality~     of life, coping, mental health and municipal costs.~   "
98808|NCT02273921|"~     The goal of this study is to construct a large database of EEG recordings from elderly~     individuals in predefined groups. The purpose of this database is to select groups of EEG~     recordings from the database in order to compare the electrophysiology, as measured by EEG,~     of the groups.~      In the clinical trial part all individuals are treated exactly the same and are therefore~     considered a single group. The categorization is performed during the data analysis.~      The groups in the data analysis will initially be based on the following:~        1. Healthy controls~        2. Mild Cognitive Impairment~        3. Alzheimers Disease (AD)~        4. Lewy-body Dementia~        5. Parkinsons Disease Dementia~        6. Vascular Dementia (VaD)~        7. Frontotemporal Dementia (FTD)~        8. Depression~      Other groups will be added if needed.~   "
98809|NCT02273908|"~     The purpose of this study is to evaluate the effect of pregabalin comparing with the~     conventional analgesic care in chronic low back pain patients with accompanying lower limb~     pain (neuropathic component) treated in primary care settings under routine clinical~     practice.~   "
98810|NCT02273895|"~     The objective of this study is to compare the electroencephalography (EEG) responses of three~     distinct groups of individuals to scopolamine: 1) a group of Alzheimer Dementia (AD)~     patients, 2) a group of individuals suffering from Mild Cognitive Impairment (MCI) and 3) a~     group of controls. The main purpose of this comparison is to discover ways to use these~     responses to distinguish between the group of AD patients and controls in order to develop a~     diagnostic tool for AD. The purpose of including the MCI group is to investigate whether this~     diagnostic tool can predict which member of the MCI group will develop AD later in life.~   "
98843|NCT02273466|"~     To assess the steady state pharmacokinetics of Desipramine with/without concomitant~     administration of Crobenetine.~   "
98813|NCT02273856|"~     The purpose of this study is to document the pharmacological treatment strategies used in~     treatment naïve and previously treated relapsed/refractory iNHL/CLL patients in the Middle~     East and North African (MENA) region. This study will also record encountered tumor subtype~     and stage and the instituted pharmacological treatments, as well as assess the clinical~     outcomes of treatments.~   "
98814|NCT02273843|"~     This is a randomized controlled trial (RCT) to evaluate the influence of different doses of~     vitamin D3 (800 IU/d versus 400 IU/d), on serum levels of interleukin (IL)-6, TNF-alpha and~     C- reactive (CRP) in premature infants with clinical evidence of late-onset sepsis and to~     assess its influence on clinical outcomes of these infants.~   "
98815|NCT02273830|"~     The purpose of this study is analyzed the impact of oxygen adjusted during exercise in COPD~     patients without conventional for LTOT but with exercise desaturation.~   "
98816|NCT02273817|"~     This study is to evaluate the equivalence of generic ciclesonide nasal spray with that of the~     marketed drug, Omnaris™ nasal spray, in the treatment of seasonal allergic rhinitis, and to~     evaluate the safety and tolerability of generic ciclesonide nasal spray compared with~     Omnaris™ nasal spray.~   "
98817|NCT02273804|"~     The purpose of this study is to evaluate the efficacy of Topiramate on the decrease of Body~     Mass Index compared to placebo at 9 months.~   "
98818|NCT02273791|"~     Evaluation of endometrial preparation using either hormonal therapy or ovarian stimulation~     prior to frozen-thawed embryo transfer (FET) in patients with polycystic ovarian syndrome~     (PCOS)~   "
98819|NCT02273778|"~     Radiotherapy is commonly used to treat advanced cancers of the head and neck, aiming for cure~     while preserving patients' quality of life including their ability to speak and swallow. In~     order to reduce the potentially major side effects of treatment, it is essential that the~     highest doses of radiotherapy are targeted to the main bulk of the tumour. At present a~     computerized tomography (CT) scan is used by the cancer specialist to identify the tumour for~     planning the radiotherapy treatment. The investigators know that other types of scan~     including magnetic resonance imaging (MRI) and positron emission tomography (PET) scans are~     better than CT scans at showing areas involved by the cancer. However, radiotherapy cannot be~     directly planned on these types of scans. The aim of this study is to explore whether PET and~     MRI scans can be combined with CT scans to more accurately identify the tumour target. In~     addition, this study will explore whether PETCT and MRI scans may used to adjust radiotherapy~     to how well a tumour is responding during a course of radiotherapy. If the radiotherapy~     planning process can be improved in these ways, the investigators hope future patients will~     benefit by more chance of cure with a reduction in the side effects of treatment. The study~     aims to recruit 16 patients. All patients within the study will undergo a PETCT and an MRI~     scan prior to starting treatment as part of the study. A subgroup of 8 patients will undergo~     additional imaging at two timepoints during the course of their radiotherapy. The study is~     noninterventional and patients' standard treatment will not be affected by their~     participation in the study.~   "
98820|NCT02273765|"~     Phase III trial evaluating raltegravir as an alternative to efavirenz for antiretroviral~     treatment of HIV-infected patients with tuberculosis.~   "
98821|NCT02273752|"~     This phase II trial studies how well real-time pharmacokinetic therapeutic drug monitoring~     works in preventing stomatitis from developing in patients with hormone receptor positive~     breast cancer, pancreatic neuroendocrine tumors, or kidney cancer that are receiving a type~     of cancer drug called everolimus. Stomatitis is a common side effect of everolimus that~     causes inflammation of the mouth, with or without oral ulcers, and frequently leads to~     patients discontinuing the medication. Monitoring the blood levels of everolimus and making~     adjustments in a patient's dose may be able to decrease the incidence of stomatitis, while~     maintaining the effectiveness of everolimus to treat the cancer.~   "
98822|NCT02273739|"~     The purpose of this Phase 1/2, multi-center study is to evaluate the safety,~     pharmacokinetics, pharmacodynamics and clinical activity of AG-221 in subjects with advanced~     solid tumors, including glioma, and with angioimmunoblastic T-cell lymphoma (AITL), with an~     IDH2 mutation. The first portion of the study is a dose escalation phase where cohorts of~     patients will receive ascending oral doses of AG-221 to determine maximum tolerated dose~     (MTD) and/or the recommended Phase 2 dose. The second portion of the study is a planned dose~     expansion phase where three cohorts of patients will receive AG-221 to further evaluate the~     safety, tolerability, and clinical activity. Anticipated time on study treatment is until~     disease progression or unacceptable toxicity occurs.~   "
98823|NCT02273726|"~     The purpose of this study is to determine whether roxadustat is effective and safe compared~     to epoetin alfa in the maintenance treatment of anemia in stable hemodialysis and peritoneal~     dialysis subjects when converted from their existing stable erythropoiesis stimulating agent~     treatment.~      Amendment 1: The primary purpose of this amendment is to evaluate safety and efficacy of~     roxadustat compared to epoetin-alfa in newly initiated (incident) dialysis subjects who have~     been on ESA (≥ 4 weeks) for treatment of anemia prior to screening~   "
98824|NCT02273713|"~     Oesophagogastric cancer is a major cause of cancer related mortality, with an overall 5-year~     survival rate of 10% worldwide and patients are often diagnosed with locally advanced or~     metastasized disease at first presentation. For advanced oesophagogastric cancer~     fluoropyrimidines are the backbone of palliative chemotherapy and is commonly used in 2- or~     3-drug combinations .~      However, in clinical practice after progression on first line therapy, a substantial number~     of oesophagogastric cancer patients may not be able to start second line chemotherapy due to~     rapid clinical deterioration. Therefore, new triplets with high anti-tumor activity and low~     toxicity are urgently needed.~      Given the activity of capecitabine and oxaliplatin containing regimens and the potential of~     taxanes in oesophagogastric cancer, the investigators propose a phase I study combining~     capecitabine and oxaliplatin with Nab-paclitaxel.~      Solvent-based taxanes (paclitaxel, docetaxel) can cause severe toxicities not only by the~     active agents itself but also by the solvents like cremophor. Nab-paclitaxel (Abraxane) is a~     solvent-free formulation of paclitaxel encapsulated in albumin. It does not require~     premedication with corticosteroids or antihistamines to prevent the risk of solvent-mediated~     hypersensitivity reactions. This new formulation improves safety profile, allows higher~     dosing with shorter infusion duration, and produces higher tumor drug concentration. It has~     proven activity in breast cancer, non small lung cancer and pancreatic cancer, as well as in~     gastric cancer models.~   "
98825|NCT02273700|"~     The main objective of this pilot study is to investigate the protein / peptide plasma~     profiles before and after treatment with a direct anti-Xa (activated Factor 10) in patients~     with non-valvular atrial fibrillation to better understand the mechanisms of action of these~     molecules and perform exploratory analyses concerning proteins whose concentrations change~     after starting treatment.~   "
98826|NCT02273687|"~     The main objective of this study is to show that diaphragmatic excursion measures upon~     emergency admission (CDA values) on patients with acute respiratory failure are predictive~     of the need to use mechanical ventilation (invasive or non-) in the first four hours.~   "
98827|NCT02273674|"~     The purpose of this study is to determine the potential effects of repetitive transcranial~     magnetic stimulation in the improvement of neuropsychological deficits and symptomatology in~     borderline personality disorder patients. Specially in cognitive flexibility, inhibition~     control and social cognition.~   "
98828|NCT02273661|"~     Compare the incidence of severe clinical exacerbations in the treatment of ABPA, between a~     strategy with a maintenance treatment and a conventional strategy without antifungal~     maintenance therapy.~   "
98829|NCT02273648|"~     For the majority of Coronary Artery Disease (CAD) treatment with Percutaneous Transluminal~     Coronary Angioplasty (PTCA) provides high initial procedure success. However, the medium to~     long-term complications range from rather immediate elastic coil or vessel contraction to~     longer processes like smooth muscle cell proliferation and excessive production of extra~     cellular matrix, thrombus formation and atherosclerotic changes like restenosis or~     angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from 30 to~     50%. Such rates of recurrence have serious economic consequences. Bare Metal Stents (BMS),~     designed to address the limitations of PTCA, reduced the angiographic and clinical restenosis~     rates in De Novo lesions compared to PTCA alone and decreased the need for CABG. BMS~     substantially reduced the incidence of abrupt artery closure, but restenosis still occurred~     in about 20 to 40% of cases, necessitating repeat procedures.~      The invention of Drug Eluting Stents (DES) significantly improved on the principle of BMS by~     adding an antiproliferative drug (directly immobilized on the stent surface or released from~     a polymer matrix), which inhibits neointimal hyperplasia. The introduction of DES greatly~     reduced the incidence of restenosis and resulted in better safety profile as compared to BMS~     with systemic drug administration. These advantages and a lower cost compared to surgical~     interventions has made DES an attractive option to treat coronary artery disease.~      Therefore this observational registry has been designed for the clinical evaluation of the~     ORSIRO LESS requiring coronary revascularization with DES. It is designed to investigate and~     collect clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting~     Stent System in an all-comers patient population in daily clinical practice.~   "
98830|NCT02273635|"~     The purpose of this study is to compare the efficacy and safety of andrographolide 140 mg~     administered twice a day orally versus a placebo as a modifying treatment of the disease in~     patients with the progressive forms of Multiple Sclerosis (MS).~      The principal outcome is to determine the efficacy, of andrographolide in retarding the~     progression of brain atrophy in patients with progressive forms of MS.~   "
98831|NCT02273622|"~     Explore the detoxifying potential of hydroxytyrosol and its effects on Phase II enzyme~     expression (leading to xenobiotics detoxification in the liver).~   "
98832|NCT02273609|"~     The primary objective of this study was to determine rates of INR control of patients with~     nonvalvular AF daily attended in primary care in Spain.~      PAULA is an observational retrospective/cross-sectional and multicenter study. Patients aged~     ≥18 years old, with nonvalvular AF, treated with VKAs for at least one year in primary care~     were included in the study. To be included, at least 80% of INR values during the past 12~     months should be available. Before inclusion, patients provided written consent.~      Clinical data (biodemographic data, comorbidities, treatments, and thromboembolic/bleeding~     risk) were recorded from the clinical history of patients at the moment of inclusion. INR~     values were taken from the previous 12 months of inclusion.~      Poor INR control was considered when percent time in therapeutic INR range (TTR) was <65%~     (calculated by Rosendaal method) or <60% by direct method (proportion of INR values).~      A total of 1,524 patients have been included in the study.~   "
98833|NCT02273596|"~     The purpose of the study is to evaluate the efficacy and safety of WTX101 administered for 24~     weeks in newly diagnosed Wilson Disease (WD) patients aged 18 and older with~     Nonceruloplasmin-bound copper (NCC) levels within or above the normal reference range at the~     time of enrollment. Subjects with Wilson Disease who have received either no prior Wilson~     Disease treatments, or have been treated for up to and including 24 months prior to study~     enrollment with chelation therapy (e.g. trientine, penicillamine), zinc therapy or~     combination therapy are eligible to participate, if all other inclusion and no exclusion~     criteria are met. The purpose of the 12 month Extension Phase is to evaluate the durability,~     and establish long-term safety and efficacy of WTX101.~   "
98834|NCT02273583|"~     Preclinical models show that a daily antiangiogenic regimen at low-dose may be effective~     against chemotherapy-resistant tumors. The aim of this study is to evaluate the efficacy of~     maintenance therapy with continuous oral cyclophosphamide and methotrexate in patients with~     high grade, operable, non-metastatic osteosarcoma (OST) of the extremities. The primary end~     point is event-free survival (EFS) from randomization.~   "
98835|NCT02273570|"~     Clinical study aimed at improving anemia management in End Stage Renal Disease Patient (ESRD)~     on maintenance Hemodialysis with evidence of Chronic Kidney disease Mineral Bone Disorder~     (CKD-MBD)~   "
98836|NCT02273557|"~     The objective of this study was to compare the pharmacokinetics of dipyridamole in three~     different Asasantin ER batches (test) containing different amounts of retarding lacquers to~     the existing commercial product at steady state with BID treatment~   "
98837|NCT02273544|"~     The objective of this study was to compare the pharmacokinetics of dipyridamole in three~     different Asasantin ER batches (test) containing different amounts of retarding lacquers to~     the existing commercial product at steady state with b.i.d. treatment~   "
98838|NCT02273531|"~     Study to establish the bioequivalence of a new formulation of Asasantin ER compared to the~     present commercially available Asasantin ER formulation (Aggrenox®)~   "
98839|NCT02273518|"~     Comparative pharmacokinetics of dipyridamole in two new formulations of Asasantin ER compared~     to the present commercial formulation~   "
98840|NCT02273505|"~     Comparative Pharmacokinetics of Asasantin Extended Release (ER) and of immediate release~     Persantin tablets combined with Acetyl salicylic acid (ASA) tablets~   "
98841|NCT02273492|"~     Comparative pharmacokinetics and pharmacodynamics of Asasantin ER at fasted and fed state~   "
98842|NCT02273479|"~     Study to investigate pharmacokinetics, pharmacodynamics and safety of RAD-SP capsule in~     multiple administration to healthy adult male volunteers.~   "
98851|NCT02273362|"~     This pilot phase I/II trial studies the best dose of erlotinib hydrochloride and to see how~     well it works in preventing liver cancer in patients with scarring (cirrhosis) of the liver.~     Erlotinib hydrochloride may help to inhibit the development of fibrous tissue and prevent~     liver cancer from forming in patients with cirrhosis of the liver.~   "
98852|NCT02273349|"~     The objective of this study is to evaluate the safety and effectiveness of the RePneu Lung~     Volume Reduction Coil (LVRC) in patients with Alpha-1-Antitrypsin deficiency (AATD) caused~     emphysema. The hypothesis is that emphysema in AATD patients shows similar tissue destruction~     profile was well as symptoms and thus will respond favorably to LVRC treatment, demonstrating~     improvement in lung function, exercise capacity, and quality of life relative to their~     baseline status.~   "
98853|NCT02273336|"~     This research trial studies genomic analysis in tissue and blood samples from young patients~     with lung cancer. Identifying specific gene mutations (changes in deoxyribonucleic acid~     [DNA]) may help doctors tailor treatment to target the specific mutations and help plan~     effective treatment.~   "
98854|NCT02273323|"~     Research indicate that people who regularly drink tea have a reduced risk of stroke or heart~     disease. In a number of studies in which people that normally do not drink showed that their~     blood vessels function improved when the drunk tea. The current study tests whether a~     specific black tea improves vessel function in non-tea drinking hypertensive subjects.~   "
98855|NCT02273310|"~     This study aims to develop an effective, brief, family-based intervention targeting quality~     of life and school functioning for youth with sickle cell disease. Utilizing a randomized,~     delayed control group intervention methodology, the present study will systematically~     document the effectiveness of a family-based, one-day intervention plus booster phone calls~     to improve quality of life and increase school functioning for children with sickle cell~     disease transitioning to school and their families.~   "
98856|NCT02273297|"~     The purpose of this study is to establish and follow longitudinally a cohort of ethnically~     diverse pregnant women and their offspring, in order to explore the hypothesis that fetal~     over-nutrition is associated with obesity, metabolic, and cardiovascular abnormalities in the~     offspring.~   "
98857|NCT02273284|"~     The use of Botulinum toxin injections (BoNT-A) has become a standard therapy for children and~     youth who suffer from stiffness of their muscles due to a neurological problem. These~     injections are given into each muscles which require treatment, which often means receiving~     multiple injections in one session. Intramuscular injections are typically painful. Treatment~     can be provided unsedated and then should incorporate distraction and relaxation techniques,~     or can be alternatively be provided with the use of sedation.~      To improve the pain experience the investigators want to assess the feasibility and impact on~     the pain perception when using a vibration device called the Buzzy during BoNT-A injections.~     The Buzzy creates a vibration that is applied over the injection site for 30 seconds before~     the injection and will be continued just above the injection site during the injection. The~     Buzzy has been shown to help reduce pain in procedures such as i.v. insertions and~     immunizations, but has not been tested in children and youth receiving multiple BoNT-A~     injections.~   "
98858|NCT02273271|"~     The purpose of the study is to qualify, independently, tumor cell proliferation by~     3'-Deoxy-3'-[18F]Fluorothymidine (FLT) -Positron Emission Tomography , and cell death by~     Diffusion Weighted Imaging (DWI) -Magnetic Resonance Imaging (MRI) compared to pathological~     quantification (% of viable tumor cells) of the primary tumor after pre-operative~     chemotherapy in patients with operable Non Small Cell Lung Cancer (NSCLC).~   "
98859|NCT02273258|"~     Primary Objective:~      To compare exposure and activity of SAR342434 to US-approved and EU-approved Humalog®.~      Secondary Objective:~      To assess the safety and tolerability of SAR342434.~   "
98860|NCT02273245|"~     Acute Aortic Syndrome (AAS) is a potentially life-threatening cause of sudden, severe chest~     pain. There are several possible underlying causes, which cannot be distinguished from one~     another at the bedside.~      Current practice is to image this with two CT scans of the chest, one before injection of a~     contrast dye into the blood stream and then one after.~      With the advancement of CT scanner technology, improvements in software interpretation and~     screen resolution, the investigators hypothesise that performing the contrast scan on its own~     is diagnostically equivalent to both the pre- and contrast scans~   "
98861|NCT02273232|"~     Remote ischemic Preconditioning (RIPC) is a phenomena first observed in cardio-thoracic~     patients in which exposing the limbs for periods of short intermittent ischemia produces~     protective effect on heart muscle. The concept was applied to many other parts of the body~     and the results are positive so far.~      No human trials on this concept has been conducted in patients with peripheral vascular~     disease so far but applying the concept for healthy individuals shows vessels dilatation and~     animal trials shows degree of new vessels formation in addition to reports of symptoms~     improvement.~      The trial candidates will be allocated blindly in 4 groups. All groups will have advice about~     exercise which is the standard practice now. The first group will have supervised exercise.~     The second group will in addition to the supervised exercise get the ischemic preconditioning~     with the blood pressure cuff. The third group will get the ischemic preconditioning and the~     fourth group will get the standard exercise advice. All candidates will have Magnetic~     Resonance Image Scan (MRA) for their blood vessels in the beginning of the trial and again at~     the end.~      The effect of the RIPC (Remote ischemic Preconditioning) and exercises on patient symptoms,~     new vessel formation and other parameters will be recorded~   "
98862|NCT02273219|"~     Primary objective is to define the maximum tolerated dose (MTD) for the combination of AEB071~     and BYL719. Secondary objectives are to define the safety and tolerability of AEB071 and~     BYL719.~   "
98928|NCT02272361|"~     The primary objective of this study is to compare with PFDI-20 questionnaire the functional~     outcome of laparoscopic sacrocolpopexy and vaginal mesh surgery in the treatment of~     symptomatic exteriorised cystocele up to 4 years after surgery.~      The secondary objectives of this study are the following:~        1. to compare the two techniques for anatomical results based on the clinical evaluation of~          patients with POP-Q.~        2. to overall quality of life assessment and expectations of patients.~        3. to compare the two techniques for the long-term safety. The evaluation will focus on the~          adverse effects of long-term sexual and genital symptoms, urinary and digestive~          functional symptoms, and chronic pelvic pain.~        4. to compare the improvement of the functional outcome assessed by PFDI-20 questionnaire~          (matched-analysis before versus after).~   "
98863|NCT02273206|"~     Bronx County, New York is the poorest urban county in the U.S.A., and residents are almost~     entirely Latino or African American. Cancer is the leading cause of premature death in the~     Bronx, with morality rates significantly higher than for New York City as a whole.~     Low-income/minority populations are more likely to be diagnosed with preventable and~     late-stage cancers than the general population, in part, due to lower screening rates. While~     research has addressed screening barriers in low-income/minority groups, depression, a~     common,potentially critical barrier, has received scant attention. Research suggests that~     depressed women are less likely to engage in cancer screening, especially mammography and Pap~     testing. The link between mental health and cancer screening is particularly important to~     address in the Bronx, which has the highest rates of self-reported serious psychological~     distress (a measure closely related to depression) in New York City. Depression affects~     almost 1 in 4 minority women, and while minorities often seek help for depression in primary~     care, primary care depression management often does not meet evidence-based standards.~     Drawing on the expertise and close collaboration of Bronx medical and social service~     providers and patient stakeholders, this study will determine whether a collaborative care~     intervention that addresses both depression and cancer screening needs simultaneously among~     women ages 50-64 is more effective at improving cancer screening and patient-reported~     outcomes for women with depression than an existing evidence-based cancer screening~     intervention alone.~      To achieve this, the investigators will compare the effectiveness of these two interventions~     using a randomized controlled trial (RCT). In partnership with three Bronx Federally~     Qualified Health Centers (FQHCs), the investigators will recruit approximately 756 women ages~     50-64 who screen positive for depression and are non-adherent with recommended cervical,~     breast, and/or colorectal cancer screenings. The investigators specific aims are to: 1)~     compare the impact of the two interventions on patient-reported outcomes, including cancer~     screening knowledge and attitudes, self-efficacy, depression-related stigma, provider~     referrals, participation in mental health care, medication adherence, quality of life,~     satisfaction with care and treatment decisions, and depression; 2) compare the effectiveness~     of the two interventions in increasing breast, cervical, and colorectal cancer screening; 3)~     determine whether reducing depression increases the likelihood that low-income women 50-64~     will receive cancer screening; 4) determine whether effectiveness of the two interventions in~     increasing cancer screening varies according to patient characteristics, such as duration of~     depression, presence of other chronic conditions, and obesity.~      This study is designed to increase the investigators understanding of how to enhance primary~     care systems' ability to improve a range of outcomes related to cancer screening and~     depression among low-income minority women, and how to best support this population in making~     cancer-screening decisions.~   "
98864|NCT02273193|"~     A prospective cohort research study is being conducted in the Mike O'Callaghan Federal~     Medical Center (MOFMC), Department of Family Medicine, Obstetrics Clinic to determine if~     early screening with hemoglobin A1C, a blood test for blood glucose, can be used to identify~     women with hyperglycemia or Gestational Diabetes Mellitus (GDM) in the first semester of~     pregnancy in place of a fasting blood glucose blood test. This study will also determine how~     hemoglobin A1C compares with the oral glucose tolerance test (GTT) done as a standard of care~     with the standard of care second trimester prenatal care testing. Subjects recruited and~     consented during the Obstetrics Orientation Class will have two (2) additional blood tests~     drawn with their standard of care prenatal tests in the first trimester (<13 weeks) of~     pregnancy and at the second trimester (24-28 weeks) of pregnancy. Subjects identified as~     having GDM by blood HbA1C, fasting glucose or the 2 hr OGTT will be treated for GDM with~     standard of care by their primary care provider. The correlation of blood HbA1C with the~     fasting glucose in the first trimester of pregnancy and with the 2 hr OGTT will be determined~     for early detection and diagnosis of GDM. This study will contribute to understanding the~     role of HbA1C in pregnancy and the development of GDM.~   "
98865|NCT02273180|"~     Primary Objective:~      To demonstrate non-inferiority of SAR342434 versus Humalog in glycated haemoglobin A1c~     (HbA1c) change from baseline to Week 26 in participants with type 1 diabetes mellitus (T1DM)~     also using insulin glargine.~      Secondary Objectives:~      To assess the immunogenicity of SAR342434 and Humalog in terms of positive/negative status~     and antibody titers at baseline and during the course of the study.~      To assess the relationship of anti-insulin antibodies with efficacy and safety including~     during the safety extension.~      To assess the efficacy of SAR342434 and Humalog in terms of proportion of participants~     reaching target HbA1c (<7%), Fasting plasma glucose (FPG), self-measured plasma glucose~     (SMPG) profiles, and insulin dose.~      To assess safety of SAR342434 and Humalog.~   "
98866|NCT02273167|"~     This study evaluates the efficacy, safety and tolerability of NER1006 versus MOVIPREP in~     adult patients requiring bowel cleansing prior to any procedure that requires a clean bowel,~     using a 2-Day evening/morning Split-Dosing and 1-Day morning only Split-Dosing regimens.~     Approximately 810 patients will be randomised with the aim of achieving a minimum of 245~     patients in each of the 3 groups.~   "
98867|NCT02273154|"~     This is a Multicenter, open lable, parallel randomized controlled clinical trial.~      This study aimed to evaluate the treatment onset time, efficacy and safety in patients with~     major depressive disorders , accompanying anxiety receiving Buspirone and Paroxetine.~   "
98868|NCT02273141|"~     This study evaluates the efficacy, safety and tolerability of NER1006 versus a sodium~     picosulfate and magnesium salt solution (SP + MS) in adult patients requiring bowel cleansing~     prior to any procedure that requires a clean bowel, using a Day Before Only Dosing regimen.~     Approximately 484 patients will be randomised with the aim of achieving a minimum of 220~     patients in each of the 2 groups.~   "
98869|NCT02273128|"~     Osteoporosis and Periodontitis are multifactorial diseases which share common risk~     factors.The aim of the present study is to ellucidate polymorphisms in Calcitonin receptor~     gene? in patients with Osteoporosis and Periodontitis.~   "
98870|NCT02273115|"~     The overall purpose of this study is to determine if adding oxytocin to a Foley catheter for~     induction of labor will increase the rate of delivery within 24 hours stratified by parity.~   "
98881|NCT02272972|"~     This study consists of a retrospective and a prospective part. For each part and in each of 5~     clinics, one intraoperative postimplant image (lateral view) of 25 patients with~     pertrochanteric fractures will be assessed by 5 surgeons per clinic. There are two~     assessments in the retrospective part. a) before an educational intervention, b) after the~     educational intervention. The evaluated images at these two timepoints are identical. In the~     prospective part, the surgeons apply their new knowledge from the educational intervention.~     They perform the positioning of the patient during the intraoperative fluoroscopy and record~     the image according to the teaching material. One postimplant image of each patient will be~     used for the evaluation.~      At all three timepoints of image assessment, a questionnaire with the same set of 7 criteria~     (Q1-Q7) for assessing the radiographs is used. The criteria refer to the content of the~     educational material.~   "
98929|NCT02272348|"~     Therapeutic education of patients is a mandatory component of intensive insulin therapy of~     type 1 diabetes in order to reach optimal safety and efficacy. Used educational methods aim~     at facilitating patients' autonomy in their own management of diabetes. Therefore,~     self-management of patient with type 1 diabetes must be systematically assessed in order to~     evaluate the effectiveness of education programs .The main objective of this prospective~     controlled randomized monocentric study is to assess the impact of functional insulin therapy~     on the level of self-management of patients with type 1 diabetes via Confidence In Diabetes~     Self-care scale (CIDS) test.~   "
98871|NCT02273102|"~     Acute Myeloid Leukemia (AML) is a diverse disease that is fatal in the majority of patients.~     Acute promyelocytic leukemia (APL) however, a subtype of AML accounting for 5% of all cases,~     is very curable. APL cells are highly sensitive to the retinoid all-trans-retinoic acid~     (ATRA), which effectively differentiates the leukemic clone. Over 80% of APL patients can be~     cured with ATRA based therapies. For patients with non-APL AML, ATRA has little effect.~     Consequently, 85% of these patients will succumb to their disease despite conventional~     approaches. Little is known about mechanisms of resistance to ATRA in non-APL AML. This~     knowledge gap limits the use of ATRA in a disease that already has few effective therapies.~     The investigators' preliminary data suggest that non-APL AML cells can be re-sensitized to~     ATRA when combined with lysine-specific demethylase 1 (LSD 1) inhibitors. The investigators'~     publication in Nature Medicine showed that LSD1 inhibition with tranylcypromine (TCP),~     unlocked the ATRA-driven therapeutic response in non-APL AML. Notably, treatment with ATRA~     and TCP markedly diminished the engraftment of primary human AML cells in murine models,~     indicating that the combination may target leukemia-initiating cells (LIC). The~     investigators' data identify LSD1 as a therapeutic target and strongly suggest that it may~     contribute to ATRA resistance in non-APL AML. The investigators' central hypothesis is that~     ATRA combined with TCP will be safe and effective in a clinical population, and that this~     approach will suppress LICs and restore myeloid differentiation programs in patients with~     non-APL AML. Testing this hypothesis with the phase I clinical trial outlined in this~     protocol, will establish a new treatment paradigm in AML and extend the important anti-cancer~     effects of ATRA to all AML subtypes.~   "
98872|NCT02273089|"~     This study intends to determine whether continuous positive airway pressure (CPAP) can reduce~     arterial stiffness (measured by pulse wave velocity) in nonsleepy as well as in sleepy~     patients with obstructive sleep apnea .~   "
98873|NCT02273076|"~     The current surgical procedure for breast diseases places an emphasis on the conservation of~     breast skin in order to provide more optimal reconstruction.~      The purpose of this study is to use portable, non-contact optical imaging device developed at~     the Beckman Laser Institute called Spatial Frequency Domain Imaging to detect the changes in~     a skin during reconstructive surgery procedure and healing process.~   "
98874|NCT02273063|"~     The purpose of this study is to see how well a treatment called Repetitive Transcranial~     Magnetic Stimulation works for patients who struggle with symptoms of both posttraumatic~     stress disorder and major depressive disorder.~   "
98875|NCT02273050|"~     A Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Trial to Evaluate the~     Efficacy and Safety of Saxagliptin in Combination with Metformin IR as Initial Therapy~     Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Subjects with Type 2~     Diabetes who have Inadequate Glycaemic Control~   "
98876|NCT02273037|"~     A novel handheld Doppler has been developed which is rugged and is powered only by a hand~     crank. This study aims to test the use of this Doppler versus the Pinard horn to monitor the~     fetal heart rate in labour in a hospital setting in Uganda. The investigators propose that~     with its ease of use, both for the woman and midwife, midwives using the Doppler will~     identify more babies in need of prompt delivery and the risk of stillbirth and neonatal~     mortality will decline. In the research study, the investigators will compare the risk of~     stillbirths and neonatal mortality in two randomized groups of labouring women.~      The second part of the study consists of an audit of the documentation in labour by midwives.~     The partograph is an uncomplicated, low cost form on which observations during labour are~     documented. It includes three sections of information: fetal condition, maternal condition~     and labour progress. Although the use of a partograph during labour is strongly recommended~     by the WHO, there are limited published systematic evaluations of the correct use of the~     tool. The investigators aim to use this randomized trial design to assess rates of~     intrapartum stillbirth and neonatal mortality in the first 24 hours after delivery, and~     assess the quality of partographs comparing two groups.~      This trial will provide insights on the potential benefits of using handheld Doppler devices~     for intrapartum monitoring, and the audit of partograph quality will provide insights to~     improve care during labour. This study hypothesizes that the quality of partograph completion~     and of fetal heart rate monitoring may systematically differ between the Doppler and Pinard~     groups.~   "
98877|NCT02273024|"~     The investigators hypothesize that inactivity during the search for a donor may exacerbate~     current deconditioned states; subsequently, influencing risk factors for post-transplant~     complications that hinder the recovery phase.~      This study is designed to investigate if exercise therapy administered prior to allogeneic~     hematologic stem cell transplantation (HSCT) can influence physical and psychological~     side-effects associated with HSCT. Approximately 6-weeks prior to HSCT, individuals will be~     randomized into either an exercise group or usual care group and followed until one year~     after HSCT.~   "
98878|NCT02273011|"~     Combined spinal epidural (CSEA) and single shot spinal anesthesia (SSSA) are both~     well-established anesthetic methods for caesarean section. CSEA combines the advantages of~     spinal anesthesia for the surgery, and epidural anesthesia for postoperative pain management.~     The aim of this randomized trial was to compare analgesia and patient satisfaction with CSEA~     continuous epidural administration of local anesthetics versus SSSA with oral pain medication~     in the postoperative period.~   "
98879|NCT02272998|"~     This phase II trial studies how well ponatinib hydrochloride works in treating patients with~     cancer that has spread to other parts of the body (metastatic), has failed previous treatment~     (refractory), and has one of several alterations, or mutations, in its deoxyribonucleic acid~     (DNA) sequence. Ponatinib hydrochloride may stop the growth of cancer cells by blocking some~     of the enzymes needed for cell growth. It is not yet known whether a patient's genetic~     alterations may affect how well ponatinib hydrochloride works.~   "
98880|NCT02272985|"~     The purpose of this study is to evaluate the effect of the hemodialysis procedure on cerebral~     blood flow (CBF) in elderly maintenance hemodialysis (HD) patients. The investigators~     hypothesize that HD induced blood pressure changes are associated with a fall in global~     and/or regional CBF during HD. Second, the investigators hypothesize that near infrared~     spectroscopy (NIRS) will correlate with CBF measured by[15O]H2O PET.~   "
98882|NCT02272959|"~     First-line psychosocial treatments for anxiety disorders in children are largely~     exposure-based cognitive behavioral therapies (CBTs). Despite strong evidence supporting~     CBT's efficacy, for up to 50% of youth patients, symptoms of anxiety persist after a full~     course of treatment. What are the treatment options for these youth? Unfortunately, there is~     not a single empirical study in the youth anxiety treatment literature that has~     systematically examined treatment augmentation for youth who fail to respond to CBT.~     Empirical efforts to address this issue are important because youth who do not respond to CBT~     continue to suffer emotional distress and impairment associated with anxiety disorders. This~     study will address this gap via double-blind randomized controlled trial of Attention Bias~     Modification Treatment (ABMT) for anxious 10-18 year-olds who did not respond to standard~     CBT. Attention biases in threat processing have been assigned a prominent role in the~     etiology and maintenance of anxiety disorders. ABMT utilizes computer-based protocols to~     implicitly modify biased attentional patterns in anxious patients. Here, participants will be~     CBT non-responders who will be assessed by using clinical interviews and parent- and~     self-rated questionnaires before and after eight sessions of ABMT or placebo control, and~     again at an eight-week follow-up. We expect to see reduction in anxiety symptoms in the~     Attention Bias Modification Treatment (ABMT) group relative to the placebo control group. We~     also expect the findings to inform pathways to treatments for anxious children who do not~     respond to current standard first-line therapy, and to provide initial information on~     mechanisms of ABMT efficacy.~   "
98883|NCT02272946|"~     The purpose of this study is to evaluate the effects of IL-1β inhibition on safety, measures~     of systemic and vascular inflammation and endothelial function (all indicators of~     cardiovascular risk) in treated and suppressed HIV infected individuals This study will~     assess the safety and effects of canakinumab on endothelial function (assessed by~     flow-mediated vasodilation [FMD] of the brachial artery), vascular inflammation (assessed by~     FDG-PET/CT scanning), key inflammatory markers of cardiovascular disease (CVD) risk~     (high-sensitivity C-reactive protein [hsCRP]), interleukin-6 (IL-6), soluble CD163 (sCD163),~     D-dimer, T-cell and monocyte activation in the blood, and size of the HIV reservoir. 20~     individuals will receive a single dose of 150mg canakinumab with follow-up for 18 weeks.~   "
98884|NCT02272933|"~     In this observational study, a motion monitoring system including body-worn sensors,~     communication portals, data capture system, and algorithms will be tested with geriatric~     patients in Garrison Geriatric Education and Care Center (Lubbock, TX). The study is part of~     a long-term effort to improve the quality of life and safety of geriatric patients by using~     autonomous systems that can alert care givers of mobility issues and falls.~   "
98885|NCT02272920|"~     Research hypothesis:~      Is the treatment with renal denervation (RDN) early post ACS safe and effective and does it~     leads to improved cardiac function and attenuation of pathologic left ventricular~     remodelling? In a following study, the hypothesis will be tested in a larger ACS population~     with major adverse cardiovascular events (MACE) after ACS as the endpoint.~      Rationale for conducting this study:~      ACS i.e. ST-elevation myocardial infarction (STEMI) and non- ST-elevation myocardial~     infarction (non-STEMI) are the most important causes of morbidity and mortality in western~     societies. Hypertension is a major risk factor for development of ACS and heart failure but~     it also worsens the prognosis in patients after ACS. Our research highlights the combination~     therapy of PCI and RDN in an ACS patient population with simultaneous hypertension.~      Primary objective:~      The primary objective of this study is to establish safety and efficacy of combined treatment~     with PCI and renal denervation (RDN) in hypertensive patients with acute coronary syndromes~     (STEMI and non-STEMI ) having ventricular mass after 4 months as the primary variable.~      Endpoints:~      The primary end point is change in left ventricular mass (LVM) at 4 months evaluated by~     magnetic resonance imaging (MRI).~      Secondary endpoints:, blood pressure (office and 24-h ABPM), and left ventricular volumes and~     ejection fraction.~   "
98886|NCT02272907|"~     The investigators hypothesize that staple line reinforcement will result in a higher leak~     pressure than a non-reinforced staple line closure in the resected gastric specimens from~     laparoscopic sleeve gastrectomy. The primary endpoint of the study is leak pressure after~     various staple line treatments. The investigators will also analyze the most common site of~     specimen leak, association of stomach thickness to leak, association of stomach thickness to~     performance of the staple line techniques, and a cost analysis.~   "
98887|NCT02272894|"~     This trial is going to evaluate the advantage of D2 radical gastrectomy plus 14v lymph node~     dissection in 3-year survival rates of advanced gastric cancers.~   "
98888|NCT02272881|"~     The purpose of this study is to compare the number of and degree of pressure ulcers healed,~     as measured by intact skin at the original ulcer site at 6 months of follow-up in patients~     randomized to immediate operative closure versus those who are maintained in a wound care~     program in patients with Stage 3 and 4 sacral and peri-sacral decubitus ulcers.~   "
98889|NCT02272868|"~     This is a double blind placebo control trial of fecal microbial transplantation for active~     Crohn's disease in patients 12 to 21 years of age.~   "
98890|NCT02272855|"~     The purpose of this study is to determine if HF10 in combination with ipilimumab is effective~     in patients with stages IIIB, IIIC, or IV unresectable or metastatic melanoma.~   "
98901|NCT02272712|"~     Chronic insomnia affects more than 25% of cancer survivors, a rate double that of the general~     population. The Pan-Canadian sleep guideline for adults with cancer recommends~     Cognitive-Behavioral Therapy for Insomnia (CBT-I) as the best treatment. Major problems,~     however, are the lack of available CBT-I at cancer centers and the lack of information about~     possible side-effects of CBT-I. To address this issue, our study will evaluate the~     effectiveness and potential short-term side-effects of an online version of CBT-I. It is~     expected that when compared to cancer survivors who receive an online sleep education~     program, those who receive online CBT-I will experience improved sleep, mood, and quality of~     life, as well as reduced anxiety and fatigue.~   "
98993|NCT02271503|"~     This is a randomized, open-label, rater-blinded, multicenter, 3-treatment, 3 period,~     single-dose crossover study. Approximately 51 qualified immediate-release (IR)~     CD-LD-experienced advanced Parkinson's disease patients will be randomized to 1 of 3 dosing~     sequences.~      Objectives:~        -  Assess the pharmacodynamics and pharmacokinetics (PK) of IPX203 (carbidopa and levodopa)~          in subjects with advanced Parkinson's disease.~        -  Characterize the safety of IPX203 in subjects with advanced Parkinson's disease.~   "
98891|NCT02272842|"~     Rationale: Globally, vitamin B12 deficiency is one of the most common micronutrient~     deficiencies. The only relevant source of Vitamin B12 is animal-source foods. Vitamin B12 is~     crucial for normal cell division and is necessary for brain growth as well as for the~     maintenance of its normal function. Deficiency is also associated with impaired growth. In a~     previous study, we demonstrated that vitamin B12 administration over a period of six months~     enhanced growth, and scores on a neuro-developmental test in young Indian children. However,~     the overall effect was small and, for the developmental scores significant only in those that~     were malnourished at the start of the study.~      Our findings need to be verified in trials targeting younger, malnourished children and with~     longer supplementation time.~      Hypothesis: This proposed study will test three hypotheses; to measure to what extent 2~     recommended daily allowances (RDA) of vitamin B12 administration for one year to stunted~     children improves; 1) growth, 2) neurodevelopment, and 3) hemoglobin concentration.~      Study design: Randomized placebo-controlled trial. Half of the children will receive a paste~     containing vitamin B12, the other half the same paste but without vitamin B12.~      Study participants and site: 600 malnourished infants in Bhaktapur municipality in Nepal. In~     this population we have demonstrated that vitamin B12 deficiency and poor growth is common in~     early childhood.~      Intervention: Daily administration of a paste containing vitamin B12 or placebo for 12 months~      Data: The main outcomes of this study are scores on developmental assessments tools and~     growth measured every month for 12 months.~   "
98892|NCT02272829|"~     This project will develop a novel collaborative treatment, based on the primary care~     behavioral consultation model and behavior therapy techniques including motivational~     interviewing and functional assessment, in which a patient, a Behavioral Health Consultant~     (BHC) and a HIV primary care provider share a unified plan targeting misuse of prescribed~     opioid analgesics in older HIV+ adults. The intervention will involve meetings between the~     BHC and the PCP, the BHC and the participant, and the BHC, PCP and the participant. Opioid~     misuse will be the primary outcome variable. Quality of the patient-provider relationship,~     pain, problematic use of other substances, antiretroviral adherence, and psychosocial~     functioning will be secondary outcomes.~   "
98893|NCT02272816|"~     Metastatic seminoma is a relatively uncommon disease. The most widely used treatment for this~     disease is chemotherapy with the drugs, cisplatin and etoposide with or without the addition~     of bleomycin. This treatment combination has shown good survival rates however it is toxic~     usually requires an inpatient visit with administration over three days and can cause~     significant nausea, malaise, alopecia, risk of kidney damage, hypertension and high tone~     hearing loss.~      Previous studies have demonstrated that carboplatin is also effective in treating this~     disease type. Progression free survival is less than that seen with the combination~     chemotherapy yet overall survival is the same between the two treatments because of the~     effectiveness of second line salvage chemotherapy. Single agent carboplatin is a less toxic~     treatment and more convenient as it is given as a day case.~      A recent study run by the Orchid Clinical Trials Group looked at whether carboplatin (AUC10)~     is not only associated with fewer side effects, but more convenient to give as an outpatient~     treatment and that it is comparable in terms of cure rate. 20 patients were recruited to the~     trial and the results were encouraging with only one relapsed patient. This patient went on~     to be cured by conventional treatment. The positive outcome of the AUC10 trial has led to the~     design of this new multi centre study.~      This open labeled, multi centre trial will recruit up to 50 patients with good prognosis~     metastatic seminoma. All patients will receive three cycles of carboplatin AUC 10. Patients~     will be followed up for survival and closely monitored for side effects during treatment.~     Patients will have a PET-CT scan before they start treatment and after the completion of~     their first cycle. We hope that this scan will help us to identify which patients have~     responded metabolically and therefore not requiring an extra cycle of chemotherapy.~   "
98894|NCT02272803|"~     The purpose of this study is to determine the efficacy of Lenalidomide/Dexamethasone +~     Elotuzumab in the subjects with newly diagnosed, previously untreated Multiple Myeloma (MM)~     in Japan.~   "
98895|NCT02272790|"~     AZD1775 in combination with carboplatin, paclitaxel, gemcitabine, or PLD.~   "
98896|NCT02272777|"~     The extension study follows the core study CAMN107ECN02, which is an open-label, two armed~     study. All patients enrolled in this extension study should be able to benefit from the~     treatment given in CAMN107ECN02 per investigator's evaluation. Therefore, in this extension~     study patient will continue treatment of the drug (imatinib or nilotinib) which they are~     taking at the end of CAMN107ECN02. Treatment arms in CAMN107ECN02 will be retained. As long~     as we get EC approval and agreement from investigators, the selected sites for CAMN107ECN02~     will be applied in this extension study.~      Patients will be enrolled after eligibility evaluation. During the study, follow-up visits at~     a frequency of 6 months are required referring to the core study and recommendation in~     Chinese CML guideline. No data collection plan is included in this extension study except~     safety data. Investigator will be asked to report AE, SAE and pregnancy in order to ensure~     compliance with pharmacovigilance requirement. AE&SAE information will be recorded in CRF and~     included in clinical database. In addition, SAE and pregnancy will be reported to Novartis~     safety database.~      The extension study will start from first patient last dose date in CAMN107ECN02 and end at~     the time of nilotinib first line treatment commercially available in China.~   "
98897|NCT02272764|"~     This study will evaluate the impact of Itraconazole on the pharmacokinetics of ALKS 5461.~   "
98898|NCT02272751|"~     This study will aim to compare the effects of an Exercise programme and a Relaxation~     Intervention in lymphoma patients in remission post-chemotherapy on quality of life,~     cardiovascular fitness, exercise tolerance, muscle strength, psychological status, social~     well-being and biological markers.~      Subjects will be recruited from a specialist lymphoma clinic in South West London and~     randomly allocated to an exercise or a relaxation home programme. The study aims to determine~     the more effective intervention of the two in relation to the outcome measures.~      The investigators anticipate that the interventions will result in less adverse events and~     improved quality of life and physical fitness, and subjects will require less medication,~     less counseling and cancer nurse specialist care, leading to leading to a reduction in~     hospital and surgery attendances.~   "
98899|NCT02272738|"~     The purpose of this study is to evaluate the clinical safety and efficacy of Gemcitabine plus~     nab-Paclitaxel chemoradiotherapy and to determine the Maximal Tolerated Dose (MTD) for~     unresectable locally advanced pancreatic adenocarcinoma.~   "
98900|NCT02272725|"~     The specific aim of this study is to evaluate the safety of non-steroidal anti-inflammatory~     drugs (NSAIDs) and their impact on renal function and/or contribution to exercise-associated~     hyponatremia (EAH) during an ultramarathon foot race. There is currently much debate over~     whether NSAID ingestion during endurance events contributes to acute kidney injury. Endurance~     events often ignite a perfect storm of physiologic insults- heat stress, dehydration, and~     myopathy- which can all negatively impact kidney function. There is a concern that NSAIDs may~     further potentiate these negative effects as well as contribute to EAH through its~     anti-diuretic affect. To date, no powered, prospective study has ever examined the effects of~     NSAIDs on either of these two biochemical outcomes~      Ultramarathon endurance events, defined as any race longer than a marathon (26.2 miles), are~     increasing in popularity, with a 10% increase in annual participants, and more than 69,000~     finishers worldwide in 2013. Considerable literature has documented alterations in serum~     biochemical profiles of these endurance athletes, with consistent evidence of elevated serum~     creatinine (Cr) levels in healthy race finishers as well as those seeking medical care. While~     acute renal failure in ultramarathon runners is a rare occurrence, acute kidney injury is~     common, ranging from 34% in a single-stage ultramarathon to 55-80% in multi-stage~     ultramarathons. The evidence is equivocal regarding NSAID ingestion and AKI. One study showed~     that runners who ingested NSAIDs prior to marathons had greater post-race creatinine levels~     than matched controls as well as higher rates of hospitalization and acute renal failure.~     However, this contrasts with several other studies that showed a marked lack of difference in~     creatinine levels or development of acute kidney injury between NSAID users and non-users~     during ultramarathons. The only randomized trial to date on this subject found no difference~     in serum creatinine levels between the NSAID and placebo groups at ultramarathon race end,~     however conclusions were limited by a small unpowered sample size.~      Exercise associated hyponatremia (EAH), defined as a serum sodium concentration below~     135mEq/L, is recognized as a relatively common issue in endurance running events. The~     incidence of EAH varies depending upon the distance of the race, with reported values of~     3-28% for marathons, 23 - 38% for triathlons and 4-51% in single-stage ultramarathons. EAH is~     likely under-diagnosed as athletes are often asymptomatic. While EAH most often manifests as~     non-specific symptoms such as nausea, vomiting, dizziness, and fatigue, it can be a~     potentially fatal disease that can progress to encephalopathy, seizures, pulmonary edema, and~     death. There have been no large prospective studies examining the relationship between EAH~     and NSAID ingestion.~   "
98917|NCT02272504|"~     The objective of this study is to evaluate the clinical effectiveness of biomarkers,~     alpha-fetoprotein (AFP), Lens culinaris agglutinin-reactive fraction of AFP (AFP-L3), and~     des-gamma-carboxy prothrombin (DCP), for surveillance program patients whose hepatocellular~     carcinoma (HCC) development may be potentially missed by ultrasound (US). This study expects~     to demonstrate that addition of biomarkers will increase the detection rate by at least 10%.~   "
98902|NCT02272699|"~     Esophageal cancer is one of common malignant tumors in China and esophageal squamous cell~     carcinoma (ESCC) is the dominant pathological type, accounting for more than 95% of all~     cases. One of our phase Ⅱ study introduced a combination treatment of an anti epithelial~     growth factor receptor (EGFR) agent, nimotuzumab, with paclitaxel and cisplatin as first-line~     treatment in unresectable or metastatic ESCC. The results showed that the overall response~     rate was 51.8% (29/56) and disease control rate was 92.9% (52/56). As a median follow-up of~     24 months, the median progression-free survival for patients with metastatic disease and~     local advanced disease were 8.2 months and more than 23 months respectively. The overall~     survival for patients with metastatic disease was 13.9 months. It implied that as first-line~     chemotherapy, an addition of nimotuzumab to chemotherapy was a more active treatment option~     compared to other regimens published in previous studies. Investigations by Liang, J. and~     Ling, Y. also suggested that nimotuzumab in combining with radiotherapy or chemotherapy also~     showed anti-tumor activities and limited toxicities.~      Therefore, we initiated this phase Ⅱ to Ⅲ clinical trial in which combining neoadjuvant~     treatments of nimotuzumab with chemotherapy or nimotuzumab with radiotherapy are compared~     with surgery alone for resectable stage Ⅱa to Ⅲ middle and lower thoracic esophageal squamous~     cell carcinoma patients. We hope to explore if these neoadjuvant combination treatments could~     bring survival benefit for ESCC patients.~   "
98903|NCT02272686|"~     The goal of this clinical research study is to learn if ibrutinib can help to control~     lymphoma in patients who have had an autologous stem cell transplant (a transplant using your~     own stem cells). The safety of this drug will also be studied.~   "
98904|NCT02272673|"~     Febrile neutropenia (FN) is a common and serious side effect of chemotherapy. Current~     management of FN is expensive and may induce side effects. Honey is a natural substance~     produced by honeybees. It possesses antioxidant, antimicrobial and anticancer effects. In~     addition, honey is not expensive. The aim of this study was to evaluate the effects of~     12-week honey consumption on children with acute lymphoblastic leukemia (ALL) particularly~     with regards of FN episodes. This randomized crossover clinical trial included 40 patients of~     both sexes, aged 2.5 to 10 years. They were randomized into two equal groups [intervention to~     control (I/C) and control to intervention (C/I)]. The dietary intervention was 12-week honey~     consumption in a dose of 2.5g//kg body weight per dose twice weekly.~   "
98905|NCT02272660|"~     Evaluated the effect of perioperative parecoxib administration on postoperative pain,~     analgesic use, function recovery, inflammatory response and bleeding risk.~   "
98906|NCT02272647|"~     Progesterone amplifies estrogen-stimulated Growth Hormone (GH) secretion in postmenopausal~     women. Preliminary data are sought to estimate statistical power for more detailed studies of~     this hypothesis.~   "
98907|NCT02272634|"~     This is a Phase 2a, proof-of-concept, multicenter, randomized, double-blind, double dummy,~     3-treatment, parallel study, with low and high YPL 001 doses (low dose and high dose twice~     daily [BID]) and a placebo control in moderate to severe Chronic Obstructive Pulmonary~     Disease (COPD) patients.~   "
98908|NCT02272621|"~     This is a single-center, open-label, randomized controlled trial. Patients scheduled for~     aortic valve replacement (AVR) at Karolinska University Hospital in Stockholm, Sweden will be~     eligible. Twenty patients will be randomly assigned to either partial upper sternotomy (20~     patients) or full sternotomy AVR (20 patients). Inclusion criteria is severe aortic stenosis~     referred for medically indicated isolated aortic valve replacement. Exclusion criteria are~     left ventricular ejection fraction less than 0.45, previous cardiac surgery, or~     urgent/emergent surgery.~      CE-marked and FDA-approved mechanical and bioprosthetic (stented or sutureless) aortic valves~     will be implanted. Cytokine release will be repeatedly assessed preoperatively and~     postoperatively (at 0, 6, 12, 18, 24 hours, and 3 days after surgery). Clinical~     characteristics will be registered. Clinical postoperative ouytcomes will be registered.~     Routine blood sampling will be performed pre- and postoperatively. All available data will be~     collected prospectively. Informed consent will be obtained from patients meeting the~     inclusion criteria before the initiation of any study-specific procedures.~   "
98909|NCT02272608|"~     There is some evidence suggesting that OSA is associated with low level of systemic~     inflammation and oxidative stress. Low level systemic inflammation and subsequent vascular~     damage has been implicated as the underlying mechanism responsible for comorbidities.~     Detection of altered inflammatory markers in OSAS patients may predict the degree of~     nocturnal sleep disturbance and associated systemic inflammation and presence of~     comorbidities. Recently, novel inflammatory biomarkers, such as neutrophil to lymphocyte~     ratio (NLR) have been proposed as an indicator of systemic inflammation. To our knowledge,~     NLR has not been studied in OSAS. We conducted the present study to evaluate the association~     between OSAS and inflammatory markers CRP, ESR and NLR.~   "
98910|NCT02272595|"~     The goal of this laboratory research study is to learn if using molecular information~     (matched therapy) or not using molecular information and having the study doctor choose the~     therapy based on your past experience are more effective ways to choose the best cancer~     treatment for you.~      This is an investigational study.~      Up to 200 participants will take part in this study. Up to 50 will be enrolled at MD~     Anderson.~   "
98911|NCT02272582|"~     A prospective randomized, double-blinded, comparative within-person study to evaluate the use~     of SOMVC001 vs. heparin dosed saline in patients undergoing CABG.~   "
98912|NCT02272569|"~     Prospective, Non-comparative, Multi-center clinical trial to evaluate the safety and efficacy~     of the STARflo Glaucoma Implant in patients with refractory open angle glaucoma.~   "
98913|NCT02272556|"~     Patients will undergo magnetic resonance spectroscopy (MRS) scanning to noninvasively measure~     intracerebral and plasma metabolite levels at baseline and following 2 and 4 hours of~     hyperglycemia. Subjects will also undergo a lumbar puncture at a separate occasion to assess~     cerebrospinal fluid levels of metabolites.~   "
98914|NCT02272543|"~     Protein-energy malnutrition (PEM) including moderate acute malnutrition (MAM:~     weight-for-height z-score <-2 to -3, or mid upper arm circumference (MUAC) 115 to < 125 mm)~     is a major cause of morbidity and mortality in under-5 children of developing/low-income~     countries. Approximately 14.6% of all under-5 mortality worldwide is attributed to MAM.~     Prevalence of MAM among under-5 children in Bangladesh is ~12% (~1.7 million). Providing a~     diet containing adequate nutrients is the mainstay of treatment of children with MAM. Dietary~     protein is mostly derived from vegetable sources for the middle and low income population~     among whom the prevalence of MAM and other forms of PEM is high. It is now possible to~     process fish into fish peptides with longer shelf-life without refrigerator, known as 'fish~     Surimi' and consumed by different categories of people who need more well-balanced protein;~     this could be an attractive alternative to supply fish protein in the diet of children in~     low-income countries like Bangladesh.~      Fish Surimi peptide is broken down from white fish meat using plant-derived enzyme and the~     ingredient is just fish meat consisted of 20 different kinds of amino acids including nine~     essential amino acids. In human studies it is found to help lowering blood lipids, glucose,~     IgE, hypertension, and increasing serum albumin and total protein, and bone density.~      The present study is designed to assess acceptability and efficacy of 'fish Surimi' in 2-5~     years old children suffering from MAM. A pilot study with two phases: to assess the i)~     acceptability with a small convenience sample (N=30) (phase 1); and ii) efficacy (rate of~     weight gain) of this fish peptide in a small convenience sample (N=70: 35 intervention 35~     control) (phase 2) is proposed.~      Acceptability trial (first phase): The investigators will conduct this study in the study~     ward of Dhaka Hospital of icddr,b. For each child the study will be for two days: i.e. direct~     observation of food intake of two lunches and two suppers. In a randomly manner and cross~     over design, an individual child will be offered 5g of fish Surimi during lunch and 5g during~     supper in one day or the same meal without any fish peptide on the other day in a blinded~     manner. The investigators will observe the completeness and eagerness of eating and any~     possible side effect (e.g. allergy, vomiting, diarrhea etc.) over these two days.~      Pilot efficacy trial (second phase): The investigators will conduct a pilot trial to assess~     the efficacy (mainly on child weight gain) of fish Surimi given at home with various~     foods/meals in 2-5 years old children with MAM will be conducted in Dhaka City of Bangladesh.~     Children will be enrolled from the Dhaka Hospital of icddr,b after improvement of any acute~     illness. The intervention group will receive (as take home supplementation) two-week's ration~     of fish Surimi (@10g/day in two doses i.e. 5g + 5g each in airtight packet), which will be~     served twice daily mixed with family diet. The control group will not be provided any~     supplements but the parents will be given dietary advice to provide nutritious food to the~     child in adequate amounts, and children of both groups will receive micronutrient sprinkle.~     The child's guardian will be supplied with fish Surimi during initial discharge from icddr,b~     hospital and requested to come for a fortnightly follow up at the nutrition follow-up unit~     (NFU) of icddr,b. During each follow-up visit the study research assistant/health worker will~     do the anthropometry, collect morbidity history since the last visit/follow up and dietary~     history will also be taken to find out how the child is doing along with the fish Surimi~     intake. Treatment of any illness will be provided as per standard method by on duty physician~     of the Dhaka Hospital of icddr,b. The ration for next two weeks will be provided and in such~     way each child will be followed for ~ 3 months over six NFU-follow-up visits. To reduce the~     possible drop-out the both-way transportation cost (~ 150 to 250 taka) during each follow-up~     visit will be reimbursed to the guardians. In the middle of the two scheduled follow-up days~     the research assistant will call the family by cell phone to monitor the child's feeding and~     morbidity status. Approximately 5ml blood will be collected from the ante-cubital vein of the~     children for biochemical test on enrolment and at the end of 3 months and will be analyzed~     for haemoglobin (Hb), c-reactive protein, zinc, ferritin, albumin, total protein, and IgE.~     During the blood drawing days each child will be given a toy (take home).~   "
98915|NCT02272530|"~     The aim of this study is to investigate wether change in endothelial nitric oxid synthase of~     blood cells (erythrocytes and peripheral blood mononuclear cells (PBMC)) has an influence on~     development and progression of cardiovascular diseases.~   "
98916|NCT02272517|"~     This study aims at evaluating the effect of vortioxetine on cognitive dysfunction in major~     depressive disorder (MDD) patients with inadequate response to current antidepressant~     treatment.~   "
98919|NCT02272478|"~     AML 18 is the replacement trial for AML16 intensive. This 1600 patient trial is primarily~     designed for patients over the age of 60 who are considered fit enough for an intensive~     chemotherapy approach and will aim to test the effects of adding 1 of 2 new treatment agents~     to commonly used chemotherapy combinations in order to improve patient survival and treatment~     regimes.~      The AML18 Trial is available to any patient who has primary or secondary AML as defined by~     the WHO Classification (excluding Acute Promyelocytic Leukaemia), or high risk~     Myelodysplastic Syndrome (i.e. >10% marrow blasts) over the age of 60.~      AML18 is a randomised controlled Phase III trial using a factorial design for maximum~     efficiency to evaluate two induction options followed by treatment with a small molecule post~     course 1 and dose intensification for suitable patients.~      There are four randomisation comparisons within the trial:~      The first randomisation will compare standard the chemotherapy schedule Daunorubicin/AraC~     (DA) combined with 1 or 2 doses of Mylotarg in course 1. Patients not suitable to receive~     Mylotarg may have DA alone. Following recovery from course 1 patients who fail to achieve CR~     or are MRD positive by centralised flow cytometry will be randomised to one of three options,~     either DA chemotherapy, DA chemotherapy plus Cladribine or Flag Ida for up to 2 courses of~     therapy.~      Patients who achieve CR after course 1 will be randomised to 1 or 2 further courses of DA~     chemotherapy.~      At course 2 all patients will also enter a randomisation to receive AC220 versus no AC220~     with or without maintenance, or Ganetespib verses no Ganetespib for a maximum of 3 cycles.~     Patients will be eligible for a non-intensive allogeneic stem cell transplant if a suitable~     HLA matched donor is available.~   "
98920|NCT02272465|"~     The Prehospital Resuscitation On Helicopter Study (PROHS) is a pragmatic, multicenter,~     prospective observational study of air ambulance-based prehospital resuscitation regimens~     currently utilized at the participating sites. Patients will be enrolled at participating~     sites that currently have blood products available on air ambulances and other sites that do~     not. This study will not change the current prehospital standard of care for resuscitation.~     The primary outcome will be in-hospital mortality and the primary unit of analysis will be~     the patient. Other outcomes of interest will include time to hemostasis, hospital~     length-of-stay, number of ventilator-free and ICU-free days, incidence of major surgical~     procedures, complications (transfusion-related acute lung injury [TRALI], acute kidney injury~     [AKI], multiple organ failure [MOF], acute respiratory distress syndrome [ARDS], sepsis,~     intra-abdominal complications, thromboembolic complications, compartment syndromes),~     lifesaving interventions, the amount and type of blood products and concentrates transfused~     (including prehospital), wastage of prehospital blood products and concentrates, use of~     external and internal hemostatic devices, and functional status at discharge/discharge~     destination.~   "
98921|NCT02272452|"~     The main ambition of this project is to develop, and provide the medical community, an~     innovative method to analyze extemporaneously, during a neurosurgery operation, excised~     tissues. This method is based on the analysis of the metabolic profile of excised tissues by~     the technique of High-Resolution Magic-Angle Spinning (HR-MAS) Nuclear Magnetic Resonance~     (NMR) spectroscopy. Indeed HRMAS NMR method can provide in a sufficiently short time lapse~     (currently about 30 minutes but within our project a time lapse of 15 min or even less is~     ultimately intended), medical information that can complement those obtained by classic~     histological examination.~      Primary purpose:~      The main objective of this study is to determine the sensitivity of HRMAS NMR spectroscopy in~     detecting residual tumor infiltration at the brain resection cavity. The investigators aim to~     determine the relevance of the metabolic analysis compared to histological analysis during a~     neurosurgery operation. This involves analyzing excised tissue samples, obtained from the~     operating rooms of Strasbourg University Hospitals, and Colmar Hospital Center, with no~     return to neurosurgeon for surgery.~      Secondary purposes:~      The secondary objectives of the protocol are to investigate the metabolome of different types~     of brain tumors, in order to find prognostic and diagnostic markers. It consists in detecting~     metabolomic factors of bad prognosis, and potential marker of good prognosis such as the IDH~     mutation.~   "
98922|NCT02272439|"~     The overall objective of this study is to determine whether serum BPA and/or phthalate~     concentrations differ in fertile versus infertile men and women in Saskatchewan. The~     investigators will test the following hypothesis:~        1. Serum BPA and/or phthalate concentrations will be greater in women with unexplained~          infertility or PCOS compared to a control group~        2. Serum BPA and/or phthalate concentrations will be greater in men with male factor~          infertility compared to a control group~   "
98923|NCT02272426|"~     It is estimated that 2 out of 3 patients with a stroke have some problems with their memory,~     difficulties performing certain tasks, making decisions and learning new things. In addition,~     many stroke patients do not get regular exercise and are often sedentary. Both physical and~     cognitive exercise have the potential to improve quality of life, cognition, and overall~     health, but the safety and tolerability of such interventions is not clear in stroke~     patients. The investigators will examine these outcomes by allocating stroke survivor~     participants to one of two groups: a combined exercise and cognitive training program and a~     sham control group.~   "
98924|NCT02272413|"~     The objective of this phase III trial is to establish statistical equivalence in terms of~     efficacy (best overall response rate [ORR], proportion of patients with complete response~     [CR] plus partial response [PR]) until 18 weeks of first-line treatment with BI 695502 plus~     chemotherapy versus Avastin® plus chemotherapy followed by maintenance monotherapy with~     either BI 695502 or Avastin®.~   "
98925|NCT02272400|"~     Partial breast irradiation (PBI) is becoming a new paradigm for breast cancer radiation.[1]~     No type I or II evidence is currently available to demonstrate equivalence to standard whole~     breast radiotherapy, and a prospective randomized trial jointly sponsored by NSABP and RTOG~     (NSABP B-39 and RTOG 0413) is currently accruing patients, comparing whole breast~     radiotherapy to PBI, either by brachytherapy or external beam techniques (EB). Until the~     results of this or similar trials are available, PBI remains a research domain, and it should~     be offered to patients only in the context of a clinical experimental protocol.~   "
98926|NCT02272387|"~     Our primary aim is to evaluate whether Vitamin D deficiency causes depressive symptoms in~     antepartum and postpartum depression and whether early correction of Vitamin D deficiency~     improves these symptoms.~      Our secondary aims evaluate maternal and fetal outcomes including antepartum, intrapartum,~     and immediate postpartum complications. We are also evaluating the effectiveness of a common~     vitamin D treatment regimen used outside of pregnancy.~   "
98930|NCT02272335|"~     The main goal of the proposed study is to test whether a successful stress management~     intervention can be effectively implemented in natural settings in the community and will be~     acceptable to a community dwelling, low income population of African American women with~     breast cancer.~      Hypothesis 1: There will be no differences between women randomized to either the Cognitive~     Behavioral Stress Management (CBSM) or the Cancer Wellness and Education condition (CW) on~     ratings of acceptability of the program.~      Hypothesis 2: Women randomized to the CBSM condition will show greater decreases over time in~     cancer-specific distress and greater increases over time in quality of life as compared to~     women in the CW condition over the course of the study from baseline to six month follow-up.~      Hypothesis 3: Women randomized to the CBSM condition will show greater improvement in pain~     levels, sleep disturbance and fatigue as compared to women in the CW condition over the~     course of the study from baseline to six month follow-up.~      Hypothesis 4: Women randomized to the CBSM condition will report fewer sick days, earlier~     return to work, fewer unanticipated health care visits, fewer visits to the Emergency~     Department and better follow-up with oncologists as compared to women in the CW condition~     over the course of the study from baseline to six month follow-up.~      Hypothesis 5: Women randomized to the CBSM condition will show more normalized patterns of~     diurnal cortisol (e.g., greater increase in negative AM-PM slope) as compared to women in the~     CW condition over the course of the study from baseline to six month follow-up.~      Hypothesis 6: Women randomized to the CBSM condition will show more less normalized patterns~     of heart rate variability (e.g., more variation) as compared to women in the CW condition~     over the course of the study from baseline to six month follow-up.~   "
98931|NCT02272322|"~     This observational study will evaluate treatment of symptomatic cystocele grade II-III with~     Cousin Biomesh and Allium Medical Endofast Reliant. Data about 100 patients will be~     collected. Follow-up till 3 years after the procedure. Primary endpoint is absence of~     recurrence.~   "
98932|NCT02272309|"~     Study part 1 will consist of sensory evoked cortical potential (SEP) measurements of the~     lower urinary tract (LUT) in healthy subjects using different stimulation frequencies from~     0.25 to 3Hz to find the most effective frequency in regard to acquisition time for reliable~     SEP response rates. Study part 2 will consist of a series of consecutive SEP measurements in~     patients with LUT symptoms during low bladder volume and maximum cystometric capacity to~     assess reliability of measurements and influence of potential concomitant LUTS treatments.~   "
98933|NCT02272296|"~     Using a specific jet injector for the administration of a rapid-acting insulin analogue has~     been shown to advance the absorption of insulin from the subcutaneous area into the~     bloodstream by 40-50%, when compared to conventional injection by insulin pens. The~     reproducibility of the jet stream method has not been previously determined in vivo. It is~     also unknown how the efficacy of injecting regular insulin by jet stream compares to that of~     rapid-acting analogues injected by conventional pen.~      Objectives: 1. To compare the pharmacologic reproducibility of the rapid-acting insulin~     analogue aspart (Novorapid®) injected by jet-injection to that of the same insulin injected~     with a conventional pen. 2. To compare pharmacokinetic and -dynamic profile of regular~     insulin injected by jet injection to that of aspart insulin injected by conventional pen.~      Study design: Double-blind double-dummy randomized controlled parallel/cross-over~   "
98934|NCT02272283|"~     Coronary artery disease is one of the most prevalent diseases in the western countries.~      A waxy substance called plaque can build up inside the coronary arteries. Over time, plaque~     can harden or rupture, and cause narrowing (stenosis) of the arteries and reduce the flow of~     oxygen-rich blood to the heart.~      The standard treatment of symptomatic coronary stenosis is percutaneous coronary intervention~     (PCI) with balloon dilation followed by stent implantation.~      A stent is a small metallic grid that stabilizes the coronary vessel wall after the balloon~     dilation.~      Currently, drug-eluting stents (DES) are the most widely used stent types. DESs consist of a~     metallic backbone and an antiprolifetive drug-coating bound by a polymer (glue). These~     devices have reduced the incidence of excessive formation of new tissue (in-stent restenosis)~     dramatically in comparison with previously used bare-metal stents.~      However, there are safety concerns with DES, since later thrombotic events have been~     reported.~      On one hand excessive tissue formation inside the stent can cause in-stent restenosis, and on~     the other hand insufficient coverage of the stent can cause persistently exposed metalllic~     material that can induce platelet aggregation and thrombus-formation.~      The etiology to stent thrombosis is multifactorial. Possible predisposing factors are, among~     others: 1) hypersensitivity towards the polymer-coating, which may induce delayed healing~     inside and around the stent, and 2) insufficient contact between the stent and the underlying~     coronary vessel wall (incomplete stent apposition), which may cause flow-disturbance and~     delayed healing.~      Delayed healing causes persistently exposed metallic material that can induce platelet~     aggregation and thrombus-formation.~      The Nobori stent is a new-generation DES, coated with a thin layer of drug and a~     bioabsorbable polymer. The drug is localized on the outer side of the stent, and decreases~     the release of drug to the blood circulation. The bioabsorbable polymer is degraded after 6-9~     months after implantation, and decreases the risk of hypersensitivity-reactions in the vessel~     wall.~      The improved pharmacokinetic profile of the stent is thought to improve the healing pattern.~      At routine coronary angiography, a small plastic tube is inserted in the femoral artery under~     local anesthesia. Thin, flexible catheters are then advanced through the artery system~     (femoral artery and aorta) to the coronary arteries. Contrast is injected in to the blood~     stream by the catheters, and the arteries are depicted by a special X-ray technique during~     dye-release. By angiography, the outer sides of the coronary arteries are visualized, and~     balloon dilations and stent implantations are guided by this standard technique.~      Newer studies have documented that stent placement and expansion is superiorly visualized if~     supplementary intravascular imaging is performed during stent implantation.~      Small imaging catheters are wired through the vessel after stent implantation, and film the~     stent retrogradely through the vessel.~      Intravascular ultrasound (IVUS) visualizes the complete vessel wall by use of sound waves,~     and stent expansion is evaluated in detail.~      Optical coherence tomography (OCT) is a newer light-based, high-resolution technology. The~     technique can depict every thread (strut) from the stent, enabling visualization of both~     contact between struts and underlying vessel wall immediately after the procedure, and strut~     coverage at follow-up.~      The purpose of this study is to determine whether OCT-guided PCI can improve healing and~     coverage of the stent in comparison with routine angiographic guidance alone in patients~     indicating PCI due to myocardial infarction.~      If OCT-guidance improves coverage of the stent, this might lower the later thrombotic risk.~      Patients hospitalized due to myocardial infarction are randomized either to OCT-guided or~     angio-guided stent implantation in the present study. In both groups the Nobori stent is~     implanted according to standard techniques. In the angio-guided group, implantations are~     guided by angiography alone. OCT- and IVUS analysis are performed after an angiographic~     optimal result for documentary reasons. The operator is blinded towards the image findings,~     and analysis is performed offline later.~      In the OCT-guided group, both OCT and IVUS analysis is interpreted immediately after the~     acquisition. If stent apposition and/or expansion is deemed suboptimal, additional balloon~     dilation and/or stenting is performed. In case of OCT-driven stent optimization, a~     documentary OCT and IVUS is performed to document the final result.~      Patients are readmitted 6 months later for a control angiogram inclusive OCT to assess stent~     coverage.~      Furthermore, patients are readmitted 12 months after the index procedure for a control~     angiogram including OCT and IVUS to assess dynamic vessel wall responses.~   "
98935|NCT02272270|"~     This will be an open label, single arm study. Subjects with newly diagnosed high grade glioma~     will begin minocycline one week prior to beginning postoperative chemoradiation and continue~     it until progression, intolerance, or the end of adjuvant temozolomide, whichever comes~     first.~   "
98936|NCT02272257|"~     The purpose of this study is to determine whether seeing a physical therapist first compared~     with seeing a physician first is more clinically and cost effective in an occupational~     setting for acute musculoskeletal conditions.~   "
98937|NCT02272244|"~     This study is designed to test a standard mailed intervention (SI) versus a novel decision~     support and navigation intervention (DSNI). Working with patients and stakeholders, this~     randomized trial will include 400 Hispanic men and women who are 50 to 75 years of age,~     patients in community based primary care practices, and are eligible for CRC screening. We~     will consent, survey, and randomize participants either to the SI Group (n=200) or the DSNI~     Group (n=200). Study specific aims are to: (1) Assess intervention (DSNI versus SI) impact on~     overall CRC screening adherence; (2)Assess intervention (DNSI versus SI) impact on CRC~     screening decision stage; (3) Assess intervention (DNSI versus SI) impact on test-specific~     CRC screening adherence; and (4) Assess intervention (DNSI versus SI) impact on CRC and~     knowledge and perceptions.~   "
98938|NCT02272231|"~     The objectives of this study are to: (1) use cultivation-independent molecular methods to~     determine the sequence of microbiological events culminating in bacterial vaginosis (BV)~     among sexually active African American women who have sex with women (AAWSW) and (2)~     determine if specific Gardnerella vaginalis oligotypes are associated with the development of~     BV among sexually active AAWSW.~   "
98939|NCT02272218|"~     The primary purpose of this study is to evaluate laparoscopic gastric banding (LAGB) surgery~     as a treatment option for obese patients with pain from knee osteoarthritis (KOA) refractory~     to medical treatment. The primary outcome will be the reduction in OA-related pain and~     disability after LAGB.~   "
98940|NCT02272205|"~     Infection is a serious complications after undergoing total hip replacement. It occurs in~     about 1% of cases. The optimal treatment of these infections is discussed. The team validated~     by international publications change strategy of the infected prosthesis at a time.~      Antibiotic prophylaxis has significantly reduced the infection intraoperative contamination~     in orthopedic surgery rates. It must be conventionally administered before the surgical~     incision. In response to infection, it is typically recommended to start this antibiotic~     after the completion of the deep bacteriological samples, so as not to negate the risk of~     these samples by the prior administration of antibiotics. This attitude, however, is not~     formally validated by the scientific literature. In contrast, two recent publications~     challenge this practice, and suggest the use of a conventional antibiotic prophylaxis even in~     septic interventions. Our multidisciplinary team opted for a few months for this new~     strategy. We wish to evaluate the influence of this new approach results in the treatment of~     infection in total hip or knee.~   "
98941|NCT02272192|"~     A multi-site randomized study of intensive treatment for toddlers with autism. This project~     proposes a three-site collaborative network plus a data coordinating center to evaluate the~     effects of intervention intensity and intervention style delivered for 12 months, on the~     developmental quotients (primary outcome) of very young children with ASD ages 12-30 months~     old and their families, and the effect of children's initial vocal skills, developmental~     rates and autism severity on their response to intervention. A second study will examine~     whether the effects of the Early Start Denver Model intervention are sustained over a three~     year period for 6-7 year old children who previously were enrolled in a two year study that~     compared ESDM treatment to usual community interventions.~   "
99007|NCT02271321|"~     The purpose of this study will be to examine the effects of white noise on agitation and~     saliva cortisol in elderly with dementia.~   "
98942|NCT02272179|"~     Adolescent suicide is the 2nd leading cause of death in this age group. There are no~     validated treatments to decrease the risk of adolescent suicidal behavior, and there are~     especially no interventions to target the highest risk period for adolescent suicide and~     suicidal behavior, namely during the time of transition from inpatient to outpatient care.~     This purpose of this project was to develop a novel, brief intervention that can be delivered~     on an inpatient unit prior to the transition to outpatient care, and augment known factors to~     protect adolescents from suicidal behavior, and extend the impact of treatment by liaison~     with the outpatient therapist and the development of a personalized safety plan phone~     application. This treatment, ASAP, focuses on augmenting adherence to the components of ASAP~     and outpatient aftercare, development of a personalized Safety Plan, and Affect Protection,~     through helping the teen and family promote a positive mood, tolerate distress, engage in~     healthy emotion regulation and access social support.~   "
98943|NCT02272166|"~     Recovery of hunger is a source of comfort for patients after general anesthesia. Moreover,~     this aspect of post-operative period is often required for discharging patients from hospital~     after ambulatory surgery. Indeed, this item is part of a multi-parameter score (Chung score)~     whose validation evaluates patient's ability to return home.~      The impact of anesthetics on hunger is largely unknown but few studies suggest an orexigenic~     effect of propofol compared to halogenated gases. These studies had neither the power nor the~     methodology to answer the question. The aim of our study is to evaluate the impact of~     propofol versus sevoflurane on early recovery of hunger after ambulatory surgery.~   "
98944|NCT02272153|"~     The satiety effects of the combination of protein and fiber within egg and whole grain~     breakfast meals. High protein with low and high-fiber is hypothesized to be more satiating~     than low protein, low fiber.~   "
98945|NCT02272140|"~     The objective of this study is to evaluate the utility of localized stimulation of the~     lumbosacral nerve roots during XLIF through correlation of observed changes in the response~     latency, amplitude, waveform morphology, and/or response threshold with surgical events.~     Additionally, correlation between neuromonitoring findings and postoperative neural status~     will be evaluated.~   "
98946|NCT02272127|"~     Non-small-cell lung cancer (NSCLC) patients with activating epidermal growth factor receptor~     (EGFR) mutations are exquisitely sensitive to epidermal growth factor receptor tyrosine~     kinase inhibitors (EGFR-TKIs) which is widely used in advanced patients. Whether treatment~     with EGFR-TKIs improves outcomes in patients with resected NSCLC harboring EGFR mutations is~     still under investigated. This study aims to observe and compare the efficacy and safety of~     intercalated combination of chemotherapy plus icotinib in patients undergoing resection of~     EGRF mutation-positive non-small cell lung cancer stagingⅠB (with high risk factor) to ⅢA.~   "
98947|NCT02272101|"~     A study of the role of vitamin D in elderly subjects with perennial and/or nonallergic~     rhinitis. The hypothesis is that vitamin D supplementation will improve rhinitis symptoms and~     rhinitis related quality of life.~   "
98948|NCT02272088|"~     The main purpose of this study is evaluate the effect of different intensities of exercise~     (moderate vs. intense) on the daily energy expenditure in overweight adolescents.~   "
98949|NCT02272075|"~     This trial will compare images obtained from a mobile colposcope with those obtained using a~     standard colposcope in women with abnormal pap smears. It is a non-inferiority trial. Blinded~     images will be evaluated be experts in colpsocopy and compared~   "
98950|NCT02272062|"~     Selection of a treatment strategy for patients with symptoms due to coronary artery disease~     requires consideration of patient preferences. In current clinical practice, patient~     preferences for treatment may not be known prior to diagnostic coronary angiography. The~     investigators will test an internet-based shared decision-making tool which will provide~     education and solicit preference information prior to angiography. The investigators seek to~     determine if this tool can accurately assess patient preferences, and if these preferences~     will lead to a change in clinical management.~   "
98951|NCT02272049|"~     The goal of this study is to evaluate the usefulness of hyperpolarized (HP) 129Xe (xenon) gas~     MRI for regional assessment of lung function in a normal population of children and adults~     and in adults and also in children with respiratory compromise due to a variety of diseases.~   "
98952|NCT02272036|"~     The purpose of this study is to analyze if integration of new media (SMS) could improve the~     quality of colonoscopy preparation.~   "
98953|NCT02272023|"~     A Phase II Randomized Clinical Trial (RCT) is proposed to compare a 9-session model of~     intensive motivational interviewing (IMI) to standard motivational interviewing techniques~     (SMI) among alcohol dependent women. Preliminary work studying 87 women randomly assigned to~     IMI or a standard single session of motivational interviewing showed significantly better~     drinking outcomes for women in the IMI condition at 4- and 6-month follow-up. Interestingly,~     mean trajectories for women assigned to IMI showed continuing declines in drinking problems~     during and after treatment. Differences between study conditions grew larger between 4-month~     (p<.05) and 6-month (p<.01) follow-up and the effect size at 6 months was medium to large~     (Cohen's d=0.63) The study will use mixed model quantitative and qualitative methods to~     respond to the PA's call for studies assessing mechanisms of change. Unlike many previous~     studies of SMI, we will employ limited exclusion criteria and will enroll participants who~     present with co-existing drug and psychiatric disorders.~      Procedures for the proposed study draw from our current successful RCT assessing IMI for~     methamphetamine (MA) dependence. Successful aspects of the current study include achievement~     of recruitment goals, strong adherence to the treatment and research protocols, and excellent~     rates for follow-up interviews (>90%). The proposed study will take place at the same~     outpatient treatment program as the current study, New Leaf Treatment Center in Lafayette,~     California.~      Participants will include 220 alcohol dependent women who will be randomly assigned to IMI or~     SMI. Those in SMI will also receive an attention component (nutrition education) to achieve~     time equivalence between the two study conditions. Participants in both groups will receive~     standard weekly group treatment offered at the program. In addition, referrals to Alcoholics~     Anonymous will be provided to all participants. The primary outcomes will be measures of~     drinking, heavy drinking (4+ drinks), and severity of alcohol problems assessed at baseline~     and 2, 6, and 12 months. Secondary outcomes will include Addiction Severity Index scales,~     psychiatric problems, and symptoms of trauma. The study will include standard quantitative~     testing of potential mediators, including, the therapeutic alliance, self-efficacy,~     motivation, satisfaction, and use of outside services. However, the application also proposes~     an innovative use of qualitative procedures to identify unrecognized factors influencing~     outcome.~   "
99008|NCT02271308|"~     This study will examine the effects of low-resistance elastic band training on muscle~     strength, flexibility, quality of life and ease of care among the residents in nursing homes.~   "
99009|NCT02271295|"~     Thrombosis occurring in the small intrahepatic, as well as in the large vessels is involved~     in the progression of cirrhosis. Anticoagulation could reduce morbidity and mortality in~     cirrhotic patients~   "
98954|NCT02272010|"~     Bipolar disorder (BD) is a chronic, often disabling illness, and many individuals remain~     symptomatic despite pharmacotherapy. Significant mood variability often persists throughout~     the lifespan and predicts relapse, leading to functional impairment. Metabolism of dietary~     essential polyunsaturated fatty acids has been shown to be upstream of the neuroinflammatory~     processes that may lead to neurotoxicity and chronicity of illness in BD. The investigators~     hypothesize that an intervention diet designed to alter intake of polyunsaturated fatty acids~     that augments mood stabilizing medications will reduce inflammation; and that the reduction~     of inflammation will reduce mood variability in bipolar disorder. After a two-the~     investigatorsek baseline-monitoring period, the investigators will randomize individuals with~     BD to an intervention or a control diet. Mood will be measured daily using a smartphone.~     Phase 2 will consist of 12 the investigatorseks of a less intense intervention. Follow-up~     will then be completed at 6, 9, and 12 months post-baseline to assess for recurrence of mood~     episodes. By maintaining a certain diet in addition to taking mood-stabilizing medication,~     researchers hope to see whether specific dietary plans have any bearing on mood variability.~   "
98955|NCT02271997|"~     Multicentre randomized controlled trial to evaluate the optimal treatment for patients who~     developed an iron deficiency after Roux-en-Y Gastric bypass.~   "
98956|NCT02271984|"~     This is a phase I, open-label, randomized, 5 period, crossover, single-center trial. The~     purpose of this trial is to assess the relative bio-availability of L-praziquantel (L-PZQ~     [MSC2499550A]) oral dispersible tablet (ODT) formulation (150 milligram [mg]) versus the~     current marketed racemate praziquantel (PZQ) (Cysticide® 500 mg) formulation in healthy male~     volunteers under fed conditions.~   "
98957|NCT02271971|"~     The purpose of this study is to determine whether supplementation with oral vitamin D~     (cholecalciferol) improves metabolic parameters in patients with moderate to severe~     psoriasis.~   "
98958|NCT02271958|"~     The purpose of this study is to evaluate the effectiveness and safety of 2.5, 5 and 10 mg~     doses of mifepristone against a placebo in women with laparoscopic diagnostic of~     endometriosis.~      The hypothesis of the study is that the 5 mg mifepristone dose is safe and effective and~     should be used in future studies on medical treatment of endometriosis.~   "
98959|NCT02271945|"~     This is a Phase 1b/2 open-label study to evaluate the safety/efficacy of MEDI-551 + MEDI0680~     in participants with relapsed or refractory aggressive B-cell lymphomas who have failed 1-2~     prior lines of therapy.~   "
98960|NCT02271932|"~     A successful non-operative management strategy for early appendicitis will decrease the~     number of children requiring surgery and may improve the quality of care related to the~     treatment of appendicitis. To account for the child-family perspective and treatment~     preferences, the investigators will perform a study in which patients and their families~     choose between antibiotics alone (Non-operative group) or appendectomy (Surgery group) at ten~     U.S. hospitals. This study will determine the effectiveness of non-operative management of~     early appendicitis with antibiotics alone in children and compare differences in morbidity,~     disability, quality of life, satisfaction, and cost between families choosing surgery or~     non-operative management.~   "
98961|NCT02271919|"~     You are a smoker and are interested in treatment that may help you quit smoking or reduce the~     amount you smoke. You have completed the screening tests for this study and were found to be~     possibly eligible.~      The goal of this clinical research study is to test 2 therapies that may help people quit~     smoking. Researchers want to find out if one is more effective than the other. The 2~     therapies are Chantix (varenicline) and a combination of a nicotine patch and nicotine~     lozenge. For participants who are still smoking after 6 weeks, the researchers also want to~     learn if it is better to continue with the same therapy or change the therapy.~      This is an investigational study. Varenicline, the nicotine patch, and the nicotine lozenge~     are FDA approved and commercially available to help people stop smoking. The study doctor can~     explain how the study drugs are designed to work.~      Up to 500 participants will take part in this study. All will be enrolled at MD Anderson.~   "
98962|NCT02271906|"~     The goal of this clinical research study is to learn if it is tolerable for patients with~     NSCLC to receive afatinib before surgery. The safety of this drug will also be studied.~   "
98963|NCT02271893|"~     The aim of this study is to assess if dextromethorphan administered during 4 weeks induces a~     decrease of pain intensity in breast cancer patients suffering from chemotherapy-induced~     peripheral neuropathy compared to placebo group.~   "
98964|NCT02271880|"~     Investigates whether a family-based intervention for adolescents with Attention Deficit~     Hyperactivity Disorder (ADHD) will improve adherence to prescribed medication regimen in~     adolescents with history of medication nonadherence.~   "
98965|NCT02271867|"~     Thermal quantitative sensory testing (QST) is a method to evaluate peripheral nerve blocks in~     a quantitative way. It assesses the neurosensory effects of local anesthetics, like nerve~     block intensity, duration, recovery, neurotoxicity, the effect of spread of local anesthetic~     solutions and the effect and the eventual neurotoxicity of adjuvants. We aimed at~     investigating, in a quantitative way, the block characteristics of 3 different commonly used~     local anesthetics on peripheral nerves through the application of thermal QST by measuring~     changes in sensory detection thresholds. Furthermore, we wanted to evaluate if QST could be~     of value for measuring gradual changes in block characteristics on the adjacent nerves at~     distance of the injection site in an US-ISB.~   "
98966|NCT02271854|"~     This study will assess the analgesic efficacy of DSG 1% compared to placebo in the reduction~     of the pain associated with DOMS~   "
98967|NCT02271841|"~     This study evaluated the practice before and after the introduction of a particular model~     pulsoxymeter giving, in addition, information on the state of fluid responsiveness of the~     patient.~   "
98968|NCT02271828|"~     STUDY AIM To decrease the number of breast cancer patients receiving over treatment of the~     axilla, in order to positively influence the axillary morbidity rate and quality of life.~      PRIMARY OBJECTIVE To determine whether omitting the sentinel lymph node procedure is not~     inferior to the current axillary staging regimen in clinically node negative breast cancer~     patients undergoing breast conserving therapy, in terms of regional recurrence rate.~      HYPOTHESIS The sentinel lymph node procedure can be safely omitted in clinically node~     negative breast cancer patients undergoing breast conserving therapy. This will lead to a~     decreased axillary morbidity rate, with a non-inferior regional recurrence-, distant-disease~     free- and overall survival rates.~   "
98969|NCT02271815|"~     There is a need for toothpastes that more effectively remove oral biofilm, and inhibit~     biofilm re-formation. This is particularly important for patients with long-term orthodontic~     fixtures or prosthodontic appliances, and also for debilitated, diabetic and~     immunocompromised patients. The objective of this study is to evaluate the effects of~     toothpastes on plaque presence and removal, dental hard tissue mineralization, erosion,~     abrasion and microstructure as well as gingival and periodontal health and dry/sore mouth. In~     addition to clinical scoring and photographs, measurements of tooth and gum sensitivity,~     saliva volume, pH and buffering, variables may be evaluated using tooth samples worn on~     removable dental retainers. These samples will be examined outside of the mouth using~     advanced optical techniques such as Optical Coherence Tomography (OCT), Fluorescence, various~     forms of microscopy and spectroscopy.~   "
98970|NCT02271802|"~     In this placebo-controlled randomized parallel study the effects of a butyrate enema on~     plasma short-chain fatty acids (SCFA) concentrations and fluxes from portal drained viscera,~     liver and the splanchnic area are investigated~   "
98971|NCT02271789|"~     The purpose of this research study is to find a new way of using light to measure the blood~     flow within the tooth.~      The researcher develop dental Laser Speckle imaging system tool that can use for exam~     condition of the tooth. This device is reliable method to provide information to dentists and~     endodontists during oral examination.~   "
98972|NCT02271776|"~     Based on our hypothesis that orally administered GOS will be fermented into a SCFA pattern~     high in acetate and that this will lead to beneficial effects on human substrate and energy~     metabolism, we aim to address the following primary objective:~      To investigate the effects of a 12-week supplementation of GOS on peripheral insulin~     sensitivity and body weight control in obese adults with impaired glucose homeostasis.~   "
98973|NCT02271763|"~     The investigators will be comparing a traditional palpation (feeling) technique with an~     ultrasound technique for finding a specific part of the neck.~   "
98974|NCT02271750|"~     The global prevalence of dementia is close to 36 million (2010). Furthermore the number is~     predicted to double in the next 20 years, primarily due to the demographic ageing. A~     perspective that will challenge the current healthcare systems and national economies.~      Dementia is characterized by progressive deterioration in cognition, function and behavior~     that is sufficiently severe to compromise social and occupational functioning.~      The pathogenesis of dementia remains elusive. Thus, there is a need to increase our~     understanding of the mechanisms leading to the most common forms of dementia. A better~     understanding of the disease may enable an earlier diagnosis and importantly, a causal~     treatment of Alzheimer as opposed to the merely symptomatic options available to day.~      An experiment with rats and memory might already have taken the first step towards this. The~     experiment has demonstrated that administration of IGF-II to rats significantly enhances~     memory retention and prevents forgetting. Furthermore inhibitory avoidance learning leads to~     an increase in the hippocampal expression of IGF-II. Finally, yet importantly, injections of~     recombinant IGF-II into hippocampus after training or memory retrieval significantly enhance~     memory retention and prevent forgetting.~      The spinal fluid and the serum will be analysed at the Medical Research Laboratory. The~     immunological concentrations of IGF-I and -II are measured by validated in-house analyses.~     Furthermore, Aarhus University Hospital has a unique technique, whereby it is possible to~     measure the bioactivity of IGF-I and -II in the cerebrospinal fluid. The concentrations of~     NGF, BDNF and sCD-163 in spinal fluid and serum will be analysed by already established~     techniques.~      The purpose of this study is therefore to define the concentration and biological activity of~     IGF-I, IGF-II, BDNF, NGF and sCD-163 in the cerebrospinal fluid and serum in patients with~     Alzheimer's compared with controls.~   "
98975|NCT02271737|"~     Newborn mortality continues to be unacceptably high in Cambodia, despite reductions in~     maternal and under five year old mortality. Evidence exists that a large proportion of~     newborn mortality globally and in Cambodia is attributable to infections and sepsis. The~     study proposes a package intervention to address infection control in the perinatal period in~     facilities and to improve the timeliness of referral of newborns with suspected infections to~     appropriate health facilities for treatment through upgrading of hygiene practices in~     facilities and linking of community based volunteers with health facilities and families in~     the community setting.~      By delivering a coordinated intervention that combines improved education for health center~     midwives, village health care workers, and mothers of newborns, along with improved care~     coordination with increase in number of interactions (points of contact) between mothers and~     health care personnel, the investigators will see improved knowledge of newborn danger signs~     among mothers and health care workers, more rapid case detection of significant newborn~     illnesses, and more rapid and appropriate referral of ill newborns.~      The investigators also hypothesize that the common causes of newborn sepsis in Cambodia are~     different from those reported in Western cultures, and that Staphylococcus aureus will be a~     common pathogen as described in neighboring Laos. The investigators will evaluate the causes~     of newborn sepsis in the subset of infants referred to Takeo Provincial Hospital.~   "
98976|NCT02271724|"~     Chronic inflammatory demyelinating polyneuropathy (CIDP) and multifocal motor neuropathy~     (MMN) are characterized by progressive deterioration in muscle strength, loss of sensibility,~     diminished or absent reflexes and impaired fine motor control. Often it is caused by~     demyelination which is suitable for treatment but damage to the axons may also occur~     especially in case of insufficient treatment.~      CIDP and MMN are immune mediated neuropathies in which first choice of treatment is~     intravenous immunoglobulin (IVIG), although the mechanisms underlying the effect of the IVIG~     is not yet clarified.~      The patients are diagnosed by electrophysiological examination and elevated level of protein~     in the cerebrospinal fluid. The diagnosis may be difficult to make due to great clinical~     variation and insensitive examinations methods including lack of biomarkers.~      The purpose of this study is to define if patients treated with SCIG and IVIG for CIDP and~     MMN have higher concentrations of sCD163 and CD19 in their cerebrospinal fluid and serum~     compared with symptomatic control subjects and is related to disease severity. Furthermore it~     is to define if patients newly diagnosed with CIDP or MMN have higher levels of sCD163 and~     CD19, than patients treated regularly with SCIG and IVIG.~   "
98977|NCT02271711|"~     The goal of this clinical research study is to learn if infusions of a particular type of~     patients' own white blood cells called natural killer (NK) cells can reliably and safely be~     given to patients with brain tumors after the cells have been through a procedure to expand~     (increase) their numbers.~      Researchers also want to learn if NK cells infused through the ommaya reservoir can help to~     control the disease in patients with advanced brain tumors. The ommaya reservoir is a~     catheter system through which NK cells will be infused directly into areas of the brain~     called the fourth ventricle or the lateral.~      This is the first study of intraventricular NK cell infusions (infusions into the ventricle~     of the brain) in humans.~   "
98978|NCT02271698|"~     The purpose of the study is three fold. First to determine the ideal dose of dexamethasone~     intraoperatively that will reduce acute pain and opioid consumption. Second determine if~     dexamethasone at the time of surgery reduces chronic pain following total knee arthroplasty~     and finally determine if a pro-inflammatory environment makes patients susceptible to chronic~     pain after surgery and can dexamethasone alter this environment. Patients undergoing total~     knee arthroplasty will be randomized to four groups ( 0mg, 6mg, 12mg and 24mg dexamethasone)~     and assessments will be made of acute and chronic pain and quality of life measures. Blood~     samples will be drawn to assess Interleukin levels and for Macrophage sorting. For the~     primary efficacy endpoint of reduction of opioid consumption over 24 hours after surgery the~     dexamethasone regimen group will be compared to standard of care group using t-test. For~     comparisons of the secondary efficacy endpoints, t-test, Chi-square test and Fisher's Exact~     test will be used. Risks of this study include the risks of venipuncture and intravenous~     dexamethasone administration.~   "
98979|NCT02271685|"~     Participants will be assigned to complete computerized estimation tasks for which there is a~     component of accuracy, such as estimating the duration of sounds. Participants will be told~     that the task is used as an early diagnostic tool to detect those at risk for a medical~     condition (e.g., Parkinson's disease, Alzheimer's disease). Instructions will be given to~     participants telling them that accuracy on the task is associated with the disease, whereas~     those who are not at risk of the disease tend to either overestimate or underestimate the~     duration of the sounds. The investigators examine whether such instructions about the purpose~     and diagnosticity of the tasks biases participants' responses to the tasks, leading them to~     purposefully be more inaccurate in their estimates.~   "
98980|NCT02271672|"~     This study was designed to demonstrate safety and efficacy of the XP1000 RF for non-invasive~     temporary reduction of waist circumference by disruption of adipocyte cells.~   "
98981|NCT02271659|"~     The aim of the present phase III study is two-folded: 1) to show a superiority of external~     beam radiotherapy combined with a brachytherapy boost versus exclusive external beam~     radiotherapy and 2) to evaluate the economic impact of each treatment.~      The study includes 33 cancer centres, the inclusion time is of 2 years and the follow-up is~     of 5 years.~   "
98982|NCT02271646|"~     Patients undergo percutaneous radiofrequency ablation of hepatic tumors at Siriraj hospital~     normally receive only intravenous sedative drugs which sometimes can not provide effective~     pain control.~      TPVB is suitable for unilateral operations. And it is increasing popular nowadays because of~     using ultrasound guided which make it is more reliable and has less side effects especially~     the severe one such as pneumothorax. To cover all nerve supply liver, we decided to use right~     TPVB at T5-6, T7-8, and T9-10.~      The aim of this study is to prove that TPVB can provide an effective pain control for~     patients undergo liver RFA both at rest and movement (cough). We are going to measure the~     pain score at recovery room and the effective pain control means patients has mild pain (pain~     score less </= 3 and do not ask for analgesic drugs).~   "
98983|NCT02271633|"~     The main aim of the current study will be to compare the effects of ingesting different~     nitrate-rich sources on plasma nitrite concentrations.~   "
98984|NCT02271620|"~     -  To determine prevalence of local allergic rhinitis (LAR)~        -  To evaluate clinical characteristic and severity of local allergic rhinitis~        -  To measure changing of tryptase and Specific IgE for Dermatophagoides pteronyssinus (Dp)~          after nasal allergen provocation test (NAPT)~   "
98985|NCT02271607|"~     This pragmatic randomized controlled study aimed to evaluate the effectiveness and safety of~     moxibustion therapy on overactive bladder (OAB) patients.~   "
98986|NCT02271594|"~     The investigators intend to assess the impact of optimized injection technique on the~     evolution of clinical parameters in insulin-treated patients with diabetes (DM) who have~     clinical lipohypertrophy (LH) in a controlled, prospective study with a follow-up of 6~     months, conducted at Ealing Hospital, West London, UK. DM patients who have LH and inject~     into it will be randomized to either switch to normal tissue sites with intensive education~     as to why and how and use of a 4mm pen needle, or to continue with standard care. The~     endpoints measured will include the impact on glucose control parameters, consumption of~     insulin, hypoglycaemia rates, use of health services resources and health care costs~   "
98987|NCT02271581|"~     There is a growing body of evidence that implicates inflammation as a mechanism of disease~     progression and reduced survival in patients with advanced cancer. Elevated c-reactive~     protein levels have been shown to be associated with reduced performance status, specific~     cancer related symptoms and reduced overall survival. C-reactive protein levels are a~     surrogate for IL-6 expression. IL-6 is part of an inflammatory signature predicting cancer~     recurrence. VeriStrat® is a multivariate test which measures protein expression related to a~     host/tumor interaction mediated by inflammation. The investigators hope to examine the~     relationship between quality of life outcomes per FACT-L survey and correlate them with~     changes in c-reactive protein levels and the VeriStrat® status. The hypothesis of this study~     is that the remarkable survival benefit in the Temel study is mediated by reduced~     inflammation with improvement of symptom control.~   "
98988|NCT02271568|"~     The purpose of this study is to determine the change in kidney function and blood pressure~     after gastric bypass versus conventional medical therapy in morbid obesity. The study mainly~     focus on glomerular filtration rate(GFR) with known relation to the renal function and 24~     hours ambulatory blood pressure monitoring after intervention of gastric bypass or medical~     treatment.~   "
98989|NCT02271555|"~     The investigators will be evaluated the effects of a single loading dose of remifentanil~     (1µg/kg), administered as an adjunct to sevoflurane, on duration of hemodynamic profile,~     seizure activity, and recovery times during electroconvulsive therapy (ECT) in patients with~     major depression~   "
98990|NCT02271542|"~     Identification of Polymorphisms Involved in the Metabolism of Propofol~   "
98991|NCT02271529|"~     The objective of this study is to evaluate the performance of the Zilver PTX stent thumbwheel~     delivery system.~   "
98992|NCT02271516|"~     This is a study to determine the maximum tolerance dose (MTD) and to evaluate the safety of~     188Re-BMEDA-liposome in patient with primary solid tumor in advanced or metastatic stage.~   "
98994|NCT02271490|"~     Introduction To get through the egg vestment and fertilize the oocyte, the spermatozoon uses~     its acrosomal enzymes. When Intracytoplasmic sperm microinjection (ICSI) is performed, the~     acrosomal enzymes are introduced with the spermatozoa inside the ooplasme.~      The fate of these enzymes, that normally never enter the oocyte, is not known. But they~     impair the embryo development.~      Indeed, although the ICSI outcome is satisfactory in humans, a series of studies in many~     species (mouse, hamster, cattle, and horse) demonstrate the deleterious effects of the~     introduction of acrosomal material in the oocyte cytoplasm, on embryo and fetal development.~     These studies have also shown two things:~        -  The bigger the acrosome, the more deleterious are the effects of their introduction into~          the egg.~        -  And that the induction of the acrosome reaction (AR) prior to ICSI significantly~          improves embryonic development and the number of babies born after embryo transfer as it~          is the case in the mouse. The microinjection of acrosome reacted sperm increases from 40~          to 70 % the percentage of pups born per embryo transferred.~      Hypothesis :~      It is possible to improve ICSI outcome, in terms of babies born in human, by induction of the~     AR prior to microinjection.~      After studying several techniques, we choose a physiologic technique for acrosome induction.~      The induction of acrosome reaction prior to ICSI should improve in utero fetal development~     and decrease the rate of miscarriage and pregnancy arrest.~   "
98995|NCT02271477|"~     Aim of this study is to determine whether Inferior Vena Cava analyzed by trans-thoracic~     echocardiography is an effective method to guide titrated fluid repletion in non critical~     patients, in order both to decrease post procedural significant hypotension rate and to avoid~     unnecessary fluid overload in patients undergoing spinal anesthesia for elective surgical~     procedures~   "
98996|NCT02271464|"~     This study consist of 4-months induction first-line chemotherapy with the G.O.N.O. FOLFOXIRI~     regimen plus bevacizumab followed by maintenance with bevacizumab or bevacizumab plus~     metronomic chemotherapy (with capecitabine and cyclophosphamide) in mCRC patients.~      The main objective of this study is to preliminarily evaluate the potential effects of the~     combination of a metronomic chemotherapy with capecitabine and cyclophosphamide to~     maintenance bevacizumab on pharmacodynamic and clinical parameters among mCRC patients.~   "
98997|NCT02271451|"~     Significant morbidity, mortality, and related costs are caused by traumatic brain injury~     (TBI). A simple, effective, and lightweight device worn by athletes or war fighters in the~     field, designed to mitigate TBI resulting from blast trauma or concussive events, would save~     lives, and the huge costs currently being experienced for life-treatment of surviving~     victims. An externally-worn medical device that applies mild jugular compression according to~     the principle of the Queckenstedt Maneuver (the Device) is being developed by Q30 Labs, LLC~     (Q30). Initial research suggests that the Device has the potential to reduce the likelihood~     of TBI. The currently developed collar (Smith 2009; Smith 2011; Smith 2011; Smith 2012) has~     been approved for studies in humans and the results indicate safety for use during high~     demand and maximal exertion activities, Study ID: 2013-2240, Institutional Review Board -~     Federalwide Assurance #00002988). Regarding safety, the externally worn collar is~     meticulously designed to mimic the body's own omohyoid muscle actions upon the jugular veins~     that will provide similar pressure and volume increases not to surpass that of a yawn or the~     mere act of just lying down.~      This study will investigate the effectiveness of this device in high school athletes playing~     a collision or contact sport such as football, hockey, or lacrosse. The high risk sports~     which utilize helmets during competition will allow for measurements systems to be embedded~     in the headgear and will not affect play or fit of equipment. Athletes participating in this~     study will be enrolled into one of two groups 1) device wearing or 2) non-device wearing. By~     the nature of the sports selected, it is likely this pilot study will primarily include~     males, however if any female meets inclusion criteria on the team selected they will be~     included in this pilot investigation. The helmets of all participants will be outfitted with~     an accelerometer which will measure the magnitude of every impact to the head sustained by~     the athlete. Effectiveness of the device will be determined by brain imaging during the~     pre-season, midseason, and end of season time points. A subset of athletes who report a~     diagnosed concussion will also receive additional brain imaging within the week following the~     diagnosed concussive event.~   "
98998|NCT02271438|"~     The purpose of this study is to assess the safety and tolerability of ibrutinib, to compare~     the pharmacokinetics of ibrutinib after single oral administration of 840 mg and 1680 mg and~     to assess the effects of a single dose of ibrutinib on QT/QTc intervals and electrocardiogram~     (ECG) in healthy adults.~   "
98999|NCT02271425|"~     Evacetrapib (study drug) is an investigational drug being developed with the aim to help~     people at high risk of heart problems in the future.~      In this study we will be comparing how much of the study drug gets into the blood stream when~     it is given as a single dose (in tablet form) compared to an intravenous injection (given~     directly into a vein via a small needle).~      The study is expected to last at least 15 days for each participant, not including screening.~     Screening will occur up to 28 days before the study drug is given.~   "
99000|NCT02271412|"~     Objectives~        -  To evaluate the safety and tolerability of escalating multiple oral doses of LY03005 in~          healthy subjects.~        -  To characterize the pharmacokinetics of escalating multiple oral doses of LY03005.~   "
99001|NCT02271399|"~     The purpose of this study is to compare the efficacy of two prophylactic agent(aspirin~     300mg/day and rivaroxaban 10mg/day) for venous thromboembolism after total knee arthroplasty.~   "
99002|NCT02271386|"~     Although numerous studies have demonstrated that a high percentage of primary care providers~     (PCPs) are knowledgeable about the American Academy of Pediatrics' guidelines for managing~     ADHD, many fail to implement these guidelines correctly. The goal of this project is to~     increase the use of evidence-based practices (EBP) for assessing and treating children with~     ADHD between 5 and 12 years in the context of primary care practice. This randomized~     controlled trial will evaluate the whether a 3-part intervention (education about ADHD~     management and communication training, collaborative consultation, and performance feedback~     regarding use of EBPs) is effective in improving EBP use among primary care providers.~   "
99003|NCT02271373|"~     The purpose of this study is to develop a school-based intervention aimed at prevent the~     onset and development of myopia among school aged children by increasing time spent outdoors~     in northeast China.~   "
99004|NCT02271360|"~     The purpose of this study is to compare the effect of oral Calcium Dobesilate to oral~     Cabergoline in the prevention of ovarian hyperstimulation syndrome (OHSS) in high-risk women~     underwent intracytoplasmic sperm injection (ICSI).~   "
99005|NCT02271347|"~     The purpose of this study is to assess the safety and tolerability of Brincidofovir (BCV)~     when administered as an initial 200mg dose followed by 100mg twice weekly (BIW) for a total~     of 5 doses.~   "
99006|NCT02271334|"~     The objective of this study is to evaluate the pharmacokinetics (PK) and safety profiles of~     A006, an Albuterol dry powder inhaler (DPI), following a single dose of 110 mcg (T1) or 220~     mcg (T2), in healthy male and female adult volunteers.~   "
99010|NCT02271282|"~     Repletion of testosterone (Te) in older men drives GH secretion after its aromatization to~     estradiol (E2), which acts via the estrogen receptor (ER). Conversely, we postulate that~     estrogen deprivation in postmenopausal women attenuates growth hormone (GH) secretion and~     insulin-like growth factor-1 (IGF-I) production, thus favoring development of metabolic~     syndrome in men treated with toremifene, a new estrogen antagonist used adjunctively in~     prostatic cancer~   "
99011|NCT02271269|"~     Glaucoma topical eye medications, when adhered to, are effective at controlling disease~     progression. Yet evidence shows that many glaucoma patients have incomplete adherence to~     medications, with disease progression resulting in significant costs to the patient and~     health system. Through the approach of value pricing, a link can be made between~     non-adherence and its resulting costs by granting subsidies to adherent patients for their~     medications and physician visits. This 6-month randomized controlled trial among 100 glaucoma~     patients from the Singapore National Eye Centre aims to test the extent to which value~     pricing can improve medication adherence.~   "
99012|NCT02271256|"~     Adolescent idiopathic scoliosis (AIS) is a prevalent chronic condition that gradually leads~     to the three dimensional deformity of the spine. Spine curvature increases in youths as~     puberty progresses. Generally, only observation is suggested for adolescents with early~     scoliosis (Cobb's angle ≤ 20°). Rigid brace treatment is too draconian for them due to the~     high corrective force which nearly constrains all movements. Flexible brace treatment is an~     alternative option; however, its efficacy is still controversial. Functional intimate apparel~     with a specialized design for teenagers with scoliosis is limited and most part of them can~     only provide some improvement for bad postures, such as hunchback. A scientific approach~     should be used to design and develop functional intimate apparel as a treatment option for~     adolescents with early scoliosis.~      This project aims to combine clinical experience with textiles and materials sciences to~     research and develop functional intimate apparel for adolescents with early scoliosis. As a~     result, this will reduce the future likelihood of brace wear or surgery.~      In this study, the eligible subjects will be given tailor-made functional intimate apparel to~     wear it 8 hours daily. Monitoring and observation will be provided during the 12-18 months~     wearing period. The effectiveness of the functional intimate apparel will be evaluated by~     pre- and post- treatment X-ray radiography.~   "
99013|NCT02271243|"~     Central line-associated bloodstream infections (CLABSIs) are the most common~     healthcare-associated infection in children and are associated with morbidity and mortality.~     This study will attempt to identify the source of bloodstream infections (BSIs) in children~     with CLABSI because we hypothesize that many of the BSIs that are currently classified as~     CLABSIs are actually laboratory-confirmed bloodstream infections (LCBI) that may be a result~     of mucosal barrier injury (MBI), also known as MBI-LCBI. In order to study this, we will~     isolate bacteria from multiple body sites of children that have BSI in order to compare these~     bacteria to the strain growing in their blood using whole-genome DNA sequencing. We will also~     evaluate biomarkers of MBI of the respiratory tract and GI tract.~   "
99014|NCT02271230|"~     This study will examine whether an intervention with vitamin D or fish oil supplements can~     reduce the risk of heart failure among adult men and women during a follow up period of up to~     five years (starting from the time of randomization into the parent VITAL trial). The~     investigators hypotheses are that both vitamin D and fish oil supplements will each reduce~     the risk of heart failure.~   "
99015|NCT02271217|"~     The objective of this study is to determine the effect of two dose strengths of~     dalfampridine-Extended Release (ER) tablets, taken twice daily for 12 weeks, on stable~     walking deficits in subjects with post-ischemic stroke.~   "
99016|NCT02271204|"~     This observational study assess the safety of intravenous Ibandronate (Bonviva) intermittent~     administration in patients with postmenopausal osteoporosis and the efficacy of IV~     Ibandronate (Bonviva treatment through relative lumbar spine and hip bone mineral~     densitometry form baseline at year 1)~   "
99017|NCT02271191|"~     The aim of this study was to demonstrate the effect of nicardipine on renal function with~     creatinine clearance, serum cystatin C, urine output and fractional excretion of sodium~     during deliberate hypotension for spine surgery.~   "
99018|NCT02271178|"~     Patients who survive an acute coronary syndrome are at high risk of recurrent events and~     death in the first months of evolution. Aspirin, angiotensin-converting enzyme, beta-blockers~     and statins decrease the risk of recurrent events and death, so are the recommended treatment~     for most patients who had a heart attack, and adherence to these recommendations is~     associated better clinical outcome. However, numerous studies show high dropout rate of~     medical treatment. The cause of nonadherence, common problem in chronic diseases, is~     multifactorial (economic, cultural, adverse effects), the complexity of the treatment being~     prescribed a relevant factor as a cause of non-compliance. The investigators goal is to~     assess whether the simplification of treatment for secondary prevention in a once-daily~     capsule containing four drugs increased adherence to it, compared to the standard treatment~     of each drug separately.~      The investigators design a controlled, randomized, open, parallel-group clinical study.~     Patients will be randomized to one of the following treatment regimens:~        -  Combined-Capsule: capsule containing an adjusted patient combination scheme for~          secondary prevention of once daily.~        -  Usual-treatment: each component of the dish separately as is the usual practice.~      The primary endpoint is the adherence of the treatment regimen to secondary prevention. For~     the study was considered adherent to a patient taking at least 80% of medication that belongs~     in the period.~   "
99019|NCT02271165|"~     The purpose of the study is to evaluate the effectiveness and safety of human immunoglobulin~     SCIg in the form of Hizentra (Immune globulin Subcutaneous) in patients with Dermatomyositis.~     Hizentra provides effective protection against infection by maintaining a steady and normal~     level of immunoglobulin in the body) in patients with primary immunodeficiency. At present,~     patients with steroid resistant dermatomyositis can only be treated with IVIg (The healthy~     antibodies in IVIG can block the damaging antibodies that attack muscle and skin in~     dermatomyositis) treatment. An evaluation can then be made to see if SCIg is a suitable~     replacement and exerts immunomodulatory effect on complement antibodies.~   "
99020|NCT02271152|"~     Atrial fibrillation (AF) is the most common cardiac arrhythmia worldwide with a prevalence of~     8% in the elderly. AF is responsible for frequent hospitalizations, stroke, heart failure and~     mortality. AF catheter ablation is an important treatment strategy for patients suffering~     from AF, but the success rate remains low after conventional pulmonary vein isolation (PVI).~     The mechanism perpetuating AF is poorly understood. Focal electrical sources and triggers~     (FAST) may sustain AF in some patients, which makes them a potential therapeutic target for~     ablation. However, finding FAST is very challenging due to complex nature of AF electrical~     signals. In this study, the investigators will attempt to localize focal electrical sources~     and triggers (FAST mapping) in patients undergoing AF ablation using custom software that~     evaluates periodicity and waveform morphology. Patients will be randomized to one of two AF~     ablation strategies, namely FAST mapping/ablation + PVI vs. PVI alone. The investigators will~     determine which strategy leads to better clinical outcome postablation.~   "
99021|NCT02271139|"~     This is an open-label, multicenter, single-arm, expanded access study designed to provide~     alectinib to participants with ALK-rearranged NSCLC after disease progression on or~     intolerance to prior ALK tyrosine kinase inhibitor (TKI) therapy. Participants will receive~     alectinib until disease progression, unacceptable toxicity, withdrawal of consent, patient or~     physician decision to discontinue treatment, death, alectinib becomes commercially available~     in the United States following approval of alectinib by the FDA, or the Sponsor decides to~     close the trial, whichever occurs first (approximately 15 months).~   "
99022|NCT02271126|"~     The best anticoagulation strategy during Extracorporeal Membrane Oxygenation (ECMO) is~     unknown. Actual recommendations suggest to use unfractionated heparin infusion and monitor~     the effect with either activated Partial Thromboplastin Time (aPTT) or Activated Clotting~     Time (ACT). Since hemorrhage is still the major adverse effect of ECMO with impact on~     mortality and morbidity, the investigators raised a question whether an alternative~     monitoring technique namely Thromboelastography (TEG) could allow a more accurate management~     of anticoagulation in this setting. To test this hypothesis the investigators designed a~     pilot study to test safety and feasibility of an anticoagulation monitoring algorithm based~     on TEG versus aPTT.~   "
99023|NCT02271113|"~     In this study, the investigators will evaluate the safety, pharmacokinetics and effect on~     target biomarkers of coagulation, cell adhesion, and leukocyte and platelet activation of~     GMI-1271, an E-selectin antagonist, in healthy volunteers.~   "
99024|NCT02271100|"~     This study is intended to determine whether ultrasound imaging can improve the ability to~     place a spinal or epidural needle in obstetric anesthesia. By evaluating the use of~     ultrasound for the placement of epidural catheters the investigators hope to answer two~     questions:~      1. How does the traditional technique based on palpation compare to one using ultrasound to~     place an epidural catheter? 2. Does ultrasound reduce one potential risk in epidural~     placement?~   "
99025|NCT02271074|"~     The main objective of this study is to compare the effectiveness of combinations of three~     patient-oriented strategies, compared to the standard of care, to increase the proportion of~     patients who enter-into-care for HIV within 90 days of testing HIV positive.~   "
99026|NCT02271061|"~     The purpose of this study to investigate joint angle and joint moment in flexion-extension,~     adduction-abduction and internal -external rotation of elastic therapeutic tape and elastic~     therapeutic tape are effective in ACL-injuries subjects during drop vertical jump.This study~     requires ACL-injuries participants age range between 18 and 45 years old. The 3D motion~     analysis system (BTS, ITALY) and force plate (Kistler, USA) will be used for measure joint~     angle and joint moment during drop vertical jump movement.~   "
99027|NCT02271048|"~     Purpose~      - The investigators aim to evaluate the feasibility of remote interpretation for ultrasound~     images using a smartphone based realtime image transmission system.~      Methods~      A total of 100 echocardiography examinations; 50 showed the ejection fraction above 50% and~     remaining 50 cases showed the ejection fraction under 50%, and 100 abdominal ultrasound~     images; 50 had signs of acute appendicitis and the other 50 had no findings of appendicitis~     will be consecutively selected. The 12 raters review these original images using an LCD~     monitor of the ultrasound machine and also an iPhone which is connected to the ultrasound~     machine via remote image transmission system (CubeView, Alpinion medical system, Seoul,~     Korea), evaluating left ventricular systolic function (for echocardiography) by measuring the~     ejection fraction and grading the probability of presence of acute appendicitis on each~     examination by a five Likert scale.~      The sensitivity and specificity between two devices will be compared and the diagnostic~     performance between two devices will be also compared. The image quality between two devices~     will be measured using the double stimulation impairment scale (DSIS)~   "
99028|NCT02271035|"~     Vesicoureteral reflux (VUR) is the most common urologic diagnosis in neonates estimated at 1%~     of newborns, and 30-45% of the children who present with urinary tract infection (1).~      Optional treatments of children with VUR include conservative therapy with or without~     prophylactic antibiotics, and endoscopic, laparoscopic, or open surgery.~      In an endoscopic technique, the injecting needle is inserted through the working channel of~     the cystoscope. The procedure is relatively short and is performed as out-patient surgery.~      In 2000, Dextranomer/Hyaluronic acid (DefluxR) was approved by the FDA, and subsequently has~     become the treatment of choice in VUR grades 2-4.~      In 2004, the hydrodistention-implantation technique (HIT) was introduced by Kirsch. HIT~     involves the use of a pressurized stream of fluid directed into the ureter to aid~     visualization, and injection into the submucosa within the ureteric tunnel to improve~     coaptation of the ureter (3).~      One of the disadvantages attributed to Deflux is the loss of 20% of the injected material~     over time (a result of absorption of the hyaluronic acid), which may explain the lower~     success rate of the endoscopic treatment of VUR compared with open surgery.~      In 2005, Polyacrylate Polyalcohol (VantrisR), a non- absorbable chemical preparation was~     introduced for endoscopic treatment of VUR, aiming to improve on the results of Deflux by~     preventing volume loss. Preliminary results of a three year follow-up using Vantris have~     shown high a level of reflux resolution(4).~      The aim of the current study is to compare the rate of resolution of the VUR using Deflux~     versus Vantris in bilateral VUR~   "
99029|NCT02271022|"~     The primary objective of the UPSTREAM Registry is to address the data gap regarding the~     course of NSTEMI (Non-ST-Elevation Myocardial Infarction)between ED (Emergency Department)~     arrival and diagnostic angiography in detail, by characterizing and following the ED and~     peri-ED use of advanced OAP (Oral Anti-Platelet) agents. In addition to exploring ED~     treatment patterns and success of both ischemic and bleeding risk stratification prior to~     definition of the coronary anatomy, data generated via the UPSTREAM registry will allow~     plausible attribution of ischemic and bleeding outcomes to pre-catheterization antiplatelet~     therapy in the management of NSTEMI. This registry further seeks to demonstrate that~     contemporary use of upstream ticagrelor is associated with an economically-sound utilization~     of hospital resources, and smooth transition of care into the outpatient, secondary~     prevention setting for the first 30 days after hospitalization. Finally, it will allow~     characterization of patient selection factors and processes for ticagrelor vs alternative OAP~     agents, carrying out that descriptive comparison through discharge. Patients transferred in~     to an UPSTREAM hospital are eligible for inclusion, but the timing for OAP agent~     administration and diagnostic catheterization begin with ED care at the first hospital.~   "
99030|NCT02271009|"~     The purpose of this study is to find the optimal dose of AllerT that should be used to treat~     moderate to severe allergies due to birch tree pollen.~      There are 4 treatment groups in this study; 3 treatment groups will receive AllerT at~     different doses and 1 treatment group will receive placebo.~      This study will also assess the effectiveness and safety of AllerT compared to placebo in~     relieving allergy symptoms.~   "
99031|NCT02270996|"~     Acute appendicitis is a common surgical emergency in children. Non-perforated appendicitis~     patients do not require antibiotics after appendectomy. Although guidelines and~     recommendations exist to decrease post-operative antibiotic mis-use after appendectomy,~     surgeons continue to prescribe unwarranted antibiotics.~      The aim of this study is to determine if an Antimicrobial Stewardship Program in Pediatric~     Surgery will decrease the use of un-warranted antibiotics.~   "
99032|NCT02270983|"~     The purpose of this study is to evaluate the safety and efficacy of linaclotide for the~     treatment of opioid-induced constipation (OIC), in adults receiving stable opioid treatment~     for chronic non-cancer pain that has been present for a minimum of 3 months.~      This study includes up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period.~     Patients meeting the entry criteria will be randomized to 1 of 2 doses of linaclotide or~     placebo for 8 weeks. This 8-week study will assess the effects of linaclotide on bowel~     movement frequency, as well as other bowel symptoms of OIC.~   "
99033|NCT02270970|"~     This will be an open label, non-randomized trial of belimumab in at least 20 subjects to test~     the feasibility of belimumab as a single agent and to capitalize on simplified background~     treatment regimens to determine immunologic differences between patients who do versus do not~     meet clinical response criteria.~   "
99034|NCT02270957|"~     This is a randomized, double blind, placebo controlled trial of abatacept for the treatment~     of lupus arthritis and other manifestations of lupus. Patients with lupus and at least 3~     tender and 3 swollen joints and </= 20 mg prednisone have other background immune~     suppressants withdrawn at entry. They can elect to receive up to a total of 320 mg depomedrol~     (in two or more injections) between the screening visit and the visit 2 months after dosing~     begins. Abatacept (125 mg) or placebo is administered in weekly subcutaneous doses. After 3~     months of treatment patients who are not responding may elect to receive open label abatacept~     with or without additional standard of care therapies. Such patients are considered non~     responders. The primary endpoint is the British Isles Lupus Assessment Group Index~     (BILAG)-linked Combined Lupus Assessment (BICLA) which will require a clinically significant~     improvement in arthritis and other active features of lupus~   "
99035|NCT02270944|"~     The purpose of the present study is to assess and compare in healthy non-pregnant women 18 to~     40 years of age the safety and immunogenicity of a liquid formulation of Group B~     Streptococcus (GBS) Trivalent Vaccine (not requiring reconstitution prior to administration),~     and of the lyophilized formulation of GBS Trivalent Vaccine, administered in non-pregnant and~     pregnant women in the clinical development program to date.~   "
99036|NCT02270931|"~     The purpose of this study is to obtain sufficient specimens and correlating clinical data~     from a well-controlled prospective clinical trial collecting longitudinal specimens from~     subjects diagnosed with any stage of breast cancer.~   "
99037|NCT02270918|"~     Apixaban is an anticoagulant (also known as blood thinner) approved by the Food and Drug~     Administration (FDA) for reducing the risk of stroke and systemic embolism in patients with~     non-valvular atrial fibrillation. It has no reliable method of reversal. Kcentra is an FDA~     approved drug derived from blood that is used as an antidote to treat people with bleeding~     associated with taking the well-known anticoagulant warfarin. This is a Phase I,~     placebo-controlled, single site, open-label, crossover trial to evaluate the reversibility~     apixaban anticoagulation with Kcentra.~   "
99038|NCT02270905|"~     The safety and performance of dCELL® Meniscus will be evaluated in 60 patients after partial~     replacement of the native medial or lateral meniscus with the investigational product.~   "
99039|NCT02270892|"~     Up to 24 subjects will be enrolled and treated. Enrolled subjects will receive two Ulthera®~     treatments, 90 days apart. Follow-up visits will occur at 90, 180, and 270 days following the~     last treatment. Study images will be obtained pre-treatment, immediately post-treatment, and~     at each follow-up visit.~   "
99040|NCT02270879|"~     Prediction errors for the first (PE1) and second eyes (PE2) were obtained in the intra-ocular~     lens power calculation for 4 formulae (HofferQ, SRK II, SRK/T and Holladay 1). The optimal~     correction factor for each formula was determined as the one resulting in the lowest mean~     absolute error. A similar analysis was performed in the negative and positive PE1 subgroups.~   "
99041|NCT02270866|"~     This is a pilot study with a single active treatment arm. The study is designed to assess the~     efficacy of a portable, non-invasive neuromodulation system for the treatment of post-stroke~     aphasia. Both language and movement assessments will be made.~   "
99042|NCT02270853|"~     In this study it will be analyzed how often the sleep apnea syndrome can be observed in~     patients with newly diagnosed lung cancer with the help of ApneaLink device by ResMed.~   "
99043|NCT02270840|"~     Effect of biventricular upgrade on left ventricular reverse remodeling and clinical outcomes~     in patient in left ventricular dysfunction and intermittent or permanent apical/septal right~     ventricular pacing (Budapest CRT upgrade study)~   "
99044|NCT02270827|"~     This study focuses on severe asthmatics and their asthma symptoms. 40% of asthma patients~     continue to experience symptoms and up to 5% of these have difficult-to-control asthma~     despite continually improving treatments. Severe asthmatics experience clinically-significant~     worse health-related quality of life than those than those with less severe asthma. Poorer~     health-related quality of life can be as a consequence of frequent, severe symptoms, which~     prevent the patient from continuing a normal, active lifestyle. The Royal Brompton Hospital~     uses the treatment regimen of intravenous (IV) Aminophylline and IV Hydrocortisone which~     appears to improve symptoms and reduce exacerbations. At present there is anecdotal evidence~     to support these assumptions. The objective of this study is to determine whether there is~     any objective evidence of improvement, in particular looking at lung function, symptoms and~     cardiovascular function.~   "
99045|NCT02270814|"~     The purpose of this research study is to look at the effect of a treatment regimen called~     CACTUX on head and neck cancer. The CACTUX regimen is a combination of three drugs called~     cisplatin, nab-paclitaxel, and cetuximab (although carboplatin may be given in place of~     cisplatin if participants have previously had problems receiving cisplatin). The use of~     nab-paclitaxel in this combination is different from routine care, in which a drug called 5FU~     is often given instead, but the investigators group has conducted previous research where the~     investigators incorporated nab-paclitaxel into routine treatment with cisplatin, 5FU, and~     cetuximab. The investigators are looking at the incidence of side effects with the CACTUX~     regimen as well as response of the disease and health status.~   "
99046|NCT02270801|"~     This clinical trial is undertaking by Qilu Hospital of Shandong University, aims at~     evaluating efficacy and safety of rhTPO in management of ITP in pregnancy.~   "
99047|NCT02270788|"~     PRIMARY OBJECTIVE:~      This is a pilot study to characterize the toxicity profile, to determine the maximum~     tolerated dose of the combination of crenolanib and sorafenib, and to determine the~     feasibility of administering these drugs in patients with relapsed or refractory hematologic~     malignancies, including acute myeloid leukemia (AML), AML with prior myelodysplastic syndrome~     (MDS), and myeloperoxidase (MPO)-positive mixed phenotype acute leukemia with FLT3-internal~     tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations.~      The study will include two phases:~        -  The dose-escalation phase will characterize the dose-limiting toxicities (DLTs) and~          determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of~          crenolanib when given in combination with sorafenib.~        -  The dose-expansion cohort will further assess the safety and explore the efficacy of~          this combination.~   "
99048|NCT02270775|"~     The study will include a translation of the Central Sensisization Inventory into French and a~     cultural validation of the French version of the questionnaire (Reliability, discrimination~     and comparison with other questionnaires).~   "
99049|NCT02270762|"~     In the critically patient bed rest and inmovilization are some of the responsable of the~     development of respiratory complications. Early physical exercise is a tool to prevent~     respiratory complications as lost of respiratory muscle strength, decrease in functional~     residual capacity and hypoxemia improving oxygenation. In some cases critically ill~     conditions implies use of pharmacological sedation. That condition limit the active physical~     exercise. However, some technicals aids as Tilt table allows execution of passive early~     movilization.~      The aim of this study is to assess the effect of early passive verticalization assisted by~     tilt table on alveolar recruitment and pulmonary ventilation in intensive care unit (ICU)~     patients, evaluated with electrical impedance tomography (EIT) ICU patients included at day~     of evaluation will be evaluated consecutively with EIT in three stages; 1) in the supine~     position (at 30° of inclination), 2) verticalized in tilt table (at 60º of inclination) 3) in~     the supine position (at 30° of inclination)~   "
99050|NCT02270749|"~     The purpose of this study is to evaluate the most effective treatment for patients who~     underwent a Roux-en-Y gastric bypass and developed postoperatively a vitamin B12 deficiency.~   "
99051|NCT02270736|"~     The objective of this study is to investigate the efficacy and safety of NT 201 compared with~     placebo for the treatment of chronic troublesome sialorrhea associated with neurological~     disorders (e.g. cerebral palsy, traumatic brain injury) and/or intellectual disability in~     children and adolescents naïve to Botulinum neurotoxin treatment and aged 2-17 years.~   "
99052|NCT02270723|"~     In a randomized clinical trial, the purpose is to investigate if perioperative coagulation~     and hemorrhage is influenced by colloid or crystalloid.~   "
99053|NCT02270710|"~     It is well known that the deregulation of immune responses plays a major role in many~     autoimmune diseases, such as Systemic Lupus Erythematosus (SLE). The main objective of this~     protocol is to determine whether the expression and/or function of specific molecules are~     deregulated in the immune cells of patients with SLE. By examining IRF4, IRF5, IBP/Def6,~     SWAP-70, Rock1, Rock2, and specific signaling molecules involved in the responsiveness to sex~     hormones, the investigators hypothesize that the deregulation in the expression and function~     of these molecules will result in abnormalities in the functioning of the immune cells, which~     is a key factor in autoimmunity.~      Peripheral blood lymphocytes from healthy controls and patients with SLE will be collected~     and compared in order to determine if specific immune cells (IL-17 and IL-21) are deregulated~     in patients with SLE and if this deregulation affects their functioning. Specifically, immune~     cells will be isolated from the blood and then subject to scientific testing (QPCR, Western~     blotting, immunofluorescence assays, ELISA and FACS analysis) to see if the expression and~     function of these cells is related to the mechanism behind SLE. This will be a case control~     study, where cases of SLE will be compared to controls of healthy volunteers to assess risk~     factors. As these healthy volunteers are providing samples solely for research purposes,~     there is no standard of care for these volunteers, with the exception of a positive HIV~     result during screening. The Department of Genetic Medicine will enroll healthy controls and~     the Hospital for Special Surgery will enroll subjects with Systemic Lupus Erythematosus (SLE)~     for a comparative analysis of the two cohorts. Laboratory testing on all blood samples will~     be done at the Hospital for Special Surgery.~   "
99054|NCT02270697|"~     The nail specimens from patients with suspect onychomycosis were analyzed. Samples were~     collected as part of standard patient care from the Department of Dermatology, National Cheng~     Kung University Hospital (NCKUH, a tertiary referral hospital), Tainan, Taiwan. Comparing the~     array results with the regular methods by sensitivity, specificity, NPV and PPV.~   "
99055|NCT02270684|"~     The purpose of this study is to compare the short-term changes in gait parameters and~     functional outcomes after total knee arthroplasty between those who use the StepRite device~     and those who follow a standard therapy program without the device.~   "
99056|NCT02270671|"~     Attention bias modification training (ABMT) is a computer-based attention training programme~     designed to modify the way a person's attention is directed to mild threats in the~     environment. What a person focuses their attention on plays an important role in how safe or~     unsafe they feel in certain situations. Much research has shown that people with high levels~     of anxiety tend to focus their attention on negative information in their surroundings. The~     purpose of ABMT is to set in place attention patterns that do not lead to excessive anxiety.~     The present study will test whether this treatment is effective in reducing social anxiety in~     15-18 year olds in school settings.~      The study design consists of two phases. During Phase 1 participants will complete a~     screening questionnaire in relation to their wellbeing and emotions. This questionnaire will~     include a measure of the affective, cognitive, and behavioural components of social anxiety~     in adolescence. Depending on their suitability (i.e. scoring above a cut-off on a~     standardised measure of social anxiety in Phase 1 of the study), participants may then be~     invited to take part in a 4-week computer-based attention training programme. The purpose of~     this phase is to see if ABMT will help young people feel less worried or nervous in social~     situations by teaching them to focus on their environment differently.~      Previous research containing attention training tasks similar to this training programme~     suggests that attention training can reduce symptoms of social anxiety in adolescents.~     Individuals who are invited to take part in the training session will be randomly assigned to~     either the intervention or placebo (inactive) group. Both groups will be asked to complete a~     4-week programme involving one computer training session per week (each session takes~     approximately 15-20 minutes).~      Questionnaires will also be given to participants to complete before and after the~     intervention, along with a 12-week follow up assessment. These will include questionnaires to~     measure social anxiety, depressive symptoms, and fears in relation to negative evaluation.~     Each questionnaire will take approximately 40 minutes to complete. Participants will not know~     whether they have received the intervention or placebo training until after the intervention.~   "
99057|NCT02270658|"~     MORPHEOS is a multicenter, randomized, unblinded study, for patients diagnosed with~     uncontrolled hypertension and at least one antihypertensive medication. Those patients with~     significant sleep apnea wil be randomized to CPAP or nasal strips for 6 months.~   "
99058|NCT02270645|"~     Laser therapy for basal cell carcinoma may be a superior option for patients who do not wish~     to or cannot tolerate other treatment modalities such as topical chemotherapeutics or~     surgery.~      In this pilot study, we will preliminarily assess the efficacy and safety of the 595/1064 nm~     Multiplex laser when treating superficial and nodular basal cell carcinomas less than 1.5 cm~     in size. This is an unblinded study in which patients will be randomized to either a~     treatment arm or a control arm. Patients in the treatment arm will receive three treatments~     with the 595/1064 nm multiplex laser spaced four weeks apart. The control group will visit~     the clinic with the same schedule as the treatment group for monitoring of the lesion. All~     patients will return one month after last treatment session or clinical visit, for evaluation~     of clinical and histological clearance.~   "
99059|NCT02270632|"~     A multicenter, randomized, parallel assignment, double blind, placebo-controlled,~     safety/efficacy phase II study of two different dosages of subcutaneous F8IL10 in patients~     with active rheumatoid arthritis receiving MTX.~   "
99060|NCT02270619|"~     Late-life depression is a major public health burden due to its high prevalence and~     associated morbidity, suicide risk, functional decline, and mortality. Unfortunately, current~     antidepressant therapies have limited effectiveness; hence, biologically plausible models for~     new treatments are being pursued. Systemic inflammation is hypothesized to play an important~     role on the onset and perpetuation of depression, especially in older women. Aging processes~     involve a heightened inflammatory state, and both inflammatory disorders and depression are~     more prevalent in women than men. However, increased systemic inflammation does not~     necessarily lead to depression in all women. Even when robust systemic inflammation is~     experimentally induced (e.g. endotoxin administration), largely variable increases in~     depressive symptoms are found. Defining the factors that account for this variability may~     identify individuals at risk of developing depression when exposed to heightened inflammatory~     states such as aging, obesity, and chronic disease, and informs future translational studies~     of depression prevention. In particular, the role of sleep disturbance in explaining this~     variability requires further attention because it is an independent risk factor for~     depression and heightens systemic inflammation by increasing the production of~     proinflammatory cytokines. The investigators have also discovered that women, but not men,~     who report sleep disturbance including short sleep duration experience significantly more~     depressive symptoms in response to an inflammatory challenge than women without sleep~     disturbance. Thus, it is hypothesized that sleep loss is a vulnerability factor for~     inflammation-induced depressive symptoms in women. However, to date, no experimental approach~     has been used to evaluate the role of sleep loss on inflammation-induced depressive symptoms.~     This proposal aims to examine this hypothesis by partial sleep deprivation (PSD) followed by~     endotoxin challenge in older women. It also aims to explore genomic and socio- emotional~     mechanisms underlying the association between sleep loss and depressive symptoms. In a~     randomized controlled factorial design, 80 healthy female volunteers aged 60 to 80 will be~     randomly assigned to one of 4 arms: 1) uninterrupted sleep followed by placebo; 2)~     uninterrupted sleep followed by endotoxin; 3) PSD followed by placebo; or 4) PSD followed by~     endotoxin. Subjects will be administered placebo or endotoxin in the morning after PSD or~     uninterrupted sleep. Depressive symptoms will be repeatedly assessed over 6 hours after~     placebo or endotoxin administration.~   "
99061|NCT02270606|"~     This phase I trial studies the side effects and best dose of fluorouracil when given together~     with radiation therapy followed by combination chemotherapy before and after surgery in~     treating patients with rectal cancer that has spread from where it started to nearby tissue~     or lymph nodes. Radiation therapy uses high energy x-rays to kill tumor cells and shrink~     tumors. Drugs used in chemotherapy, such as fluorouracil, leucovorin calcium, and~     oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Giving more than~     one drug (combination chemotherapy) before surgery may make the tumor smaller and reduce the~     amount of normal tissue that needs to be removed. Giving additional combination chemotherapy~     after surgery may kill any remaining tumor cells. Giving radiation therapy and fluorouracil~     followed by combination chemotherapy before and after surgery may be a better treatment for~     rectal cancer.~   "
99062|NCT02270593|"~     Placenta previa totalis (accreta, increta, percreta); ADAMTS and proteoglycans and the~     oxidant / antioxidant enzyme levels.~   "
99063|NCT02270580|"~     A randomized controlled trial (RCT) with 2 patient navigator conditions: PN+ and usual PN in~     which (condition 1) we will evaluate the efficacy of a culturally tailored PN program (PN+)~     on improving quality of life (QoL), screening practices and treatment follow-up compliance~     among breast HL survivors. In usual PN, participants will receive information brochures on~     breast cancer survivorship and have a minimum of 1 contact with the patient navigator.~   "
99095|NCT02270164|"~     Pycrinil® is a purified extract of the artichoke leaf. Artichoke leaf extract (ALE) has some~     clinical trial data suggesting benefit in the treatment of cholesterol disorders in several~     countries, but this effect has not been studied in a U.S. population. The investigators will~     give ALE or a placebo to overweight men and women with low good cholesterol to see if ALE~     increases their good cholesterol. The investigators will also make sure that ALE is safe.~   "
99144|NCT02269527|"~     The use of live music in SICU might affect the perception of noise, which may reduce staff's~     stress level and further decrease the possibility of clinical errors, reduce patient's~     anxiety and perception of pain as well as increase compliance from patient and family. Live~     music might also enhance the quality of stay and promote a holistic healing process for the~     patient.~   "
99064|NCT02270567|"~     Neuroendocrine tumors are derived from the neuroendocrine system of the~     gastroenteropancreatic and bronchopulmonary tract systems. Treatment options include surgery,~     medical and ablative therapies as well as peptide-receptor radionuclide therapy. Survival is~     linked to early and accurate diagnoses or to the effective detection of disease recurrence~     and/or treatment failure. One challenge is to develop accurate non-invasive blood tests that~     can detect neuroendocrine tumor activity. A second challenge is to evaluate the effectiveness~     of molecular biomarkers in the natural history of this disease. RegisterNET registry aims at~     collecting data and blood samples from patients presenting with a NET in the USA. Data will~     be entered prospectively and anonymized after informed consent. All physicians who treat~     neuroendocrine tumor patients are invited to participate to the registry. Data will be~     evaluated within regular time frames, focusing on diagnostic accuracy for biomarkers in the~     different types and grades of tumors, treatment modalities and patient outcomes (e.g. disease~     recurrence and survival), thereby contributing to an understanding of the role of biomarkers~     in tumor management.~   "
99065|NCT02270554|"~     The aim of this study is to evaluate if the Endo GIA Reinforced Reload with Tri-Staple~     Technology reduce incidence of pancreatic fistula (ISGPF grade B and C) after distal~     pancreatectomy by a prospective, multi-center trial.~   "
99066|NCT02270541|"~     Interventional prospective randomized open blinded end-point (PROBE) single-center clinical~     trial on the evaluation of the efficacy, safety, feasibility, reliability, and~     cost-effectiveness of in-ambulance telemedicine for patients with suspicion of acute stroke.~   "
99067|NCT02270528|"~     This study will examine the acute effects of high intensity interval ergometry on peripheral~     concentrations of lactate and hydrogen ions, as well as cognitive function. Approximately 60~     healthy, college-aged males will participate in the Wisconsin Card Sorting Task (WCST), a~     measure of executive function, two times over a span of two weeks. Prior to the WCST,~     participants will complete either a warm-up, a warm-up and high intensity interval exercise,~     or a stationary period. Changes in lactate, pH, and WCST score will be evaluated between and~     within groups in relation to the presence of the high intensity exercise stimulus.~   "
99068|NCT02270515|"~     This study will implement and evaluate a patient-centered medical home for kidney disease~     (PCMH-KD) compared to the usual model of dialysis care. Patients will be observed for an~     initial baseline period under the usual care model and then the usual dialysis care team will~     be expanded to include a pharmacist, community health worker, nurse coordinator and a primary~     care doctor. Outcomes of interest will be assessed at baseline and then every 6 months after~     the PCMH-KD intervention commences.~   "
99069|NCT02270502|"~     The primary aim of the study is to evaluate consequences of frailty in critically ill~     patients. We hypothesize that a higher frailty index (based on published questionnaires)~     predicts a longer surgical intensive care unit and hospital length of stay, less~     ventilator-free days and a higher likelihood of an adverse discharge disposition.~      Our secondary aim is to identify muscle-size derived variables that can be used to predict~     frailty. We hypothesize that a low skeletal muscle mass measured by ultrasound can be used to~     quantify frailty, and to also predict the outcome of SICU patients, expressed as longer stay~     in the surgical intensive care unit and longer stay in the hospital, less ventilator-free~     days and a higher likelihood of an adverse discharge disposition.~      Our third aim is to examine potential triggers of muscle wasting in critically ill patients.~     Muscle wasting will be assessed by repetitive ultrasound measurements of muscle mass. We~     hypothesize that a significant decrease in skeletal muscle mass predicts longer stay at the~     surgical intensive care unit and longer hospital length of stay, less ventilator-free days~     and adverse discharge disposition.~   "
99070|NCT02270489|"~     This is a randomized controlled parallel Group phase I study to investigate the safety and~     immunological/ therapeutic activity of two new vaccines, AFFITOPE® PD01A and AFFITOPE® PD03A,~     given to patients with early Multiple System Atrophy (MSA).~      In total 30 patients are planned to be enrolled in the study: 12 patients in each treatment~     arm who will receive either 75µg AFFITOPE® PD01A (with adjuvant) or 75µg AFFITOPE® PD03A~     (with adjuvant) and 6 patients in the control group who will receive the reference substance~     (Placebo). Over a study duration of 52 weeks, the study participants will receive 4~     injections as basic immunization in a 4-weekly interval and 1 boost immunization 36 weeks~     after the first injection. Male and female patients aged 30 to 75 years can participate in~     the trial. 2 study sites in France (Bordeaux and Toulouse) will be involved.~      AFF009 is part of the project SYMPATH funded by the European Commission~     (FP7-HEALTH-2013-INNOVATION-1 project; N° HEALTH-F4-2013-602999).~   "
99071|NCT02270476|"~     The purpose of this study is to further characterize early CF lung disease in newborns,~     infants and toddlers with cystic fibrosis (CF).~   "
99072|NCT02270463|"~     This is a non-randomized open label multi-center study. Patients who are in their first~     complete remission (CR) following induction therapy will be treated with SL-401, which will~     be administered as a brief intravenous infusion for 5 consecutive days every 28 days for 6 or~     more cycles. Stage 1 will consist of a period in which approximately 6-9 patients will be~     treated with SL-401 at 3 dose levels. During Stage 2, up to approximately 20 patients with~     minimal residual disease (MRD) in their bone marrow will be treated at a maximum tolerated~     dose or maximum tested dose in which multiple dose-limiting toxicities are not observed~     (identified in Stage 1).~   "
99073|NCT02270450|"~     This partially randomized clinical trial studies surgery or non-surgical management in~     treating patients with intra-abdominal cancer and bowel obstruction. Bowel obstruction is a~     common problem for advanced cancer patients and can negatively affect quality of life. It is~     not yet known whether surgery or non-surgical management is the best treatment option for~     bowel obstruction and can lead to better quality of life.~   "
99074|NCT02270437|"~     We investigated the safety and efficacy of the bilateral periarticular cocktail injection at~     a reduced dosage in patients undergoing simultaneous bilateral total knee arthroplasty.~   "
99075|NCT02270424|"~     The aim of this study is to compare the effectiveness of two treatments for severe / very~     severe COPD patients: one, conventional medicine based on 2013 Global Initiative for Chronic~     Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines; the other, TCM treatments~     and conventional medicine, which have been evaluated and have certain effect.~   "
102072|NCT02231268|"~     -  Evaluation of a 6-months treatment with Gladem~        -  Experiences with the internet for performing a postmarketing study (PMS) trial~   "
99076|NCT02270411|"~     The objective of this non-therapeutic experiment is to develop a method to isolate~     inflammatory cells from skin biopsies as well as a method to evaluate the expression of genes~     in those cells that are involved in inflammation. It could eventually be used to better~     understand the following conditions: atopic dermatitis, acne rosacea and acne vulgaris. It~     can also be used to better understand how various medications work in patients with atopic~     dermatitis, acne rosacea and acne vulgaris.~      Up to 15 healthy volunteers, 15 subjects with atopic dermatitis, 15 subjects with acne~     rosacea and up to 15 subjects with acne vulgaris will be selected. For healthy volunteers and~     subjects with atopic dermatitis, a maximum of four (4) skin biopsies (2-4 mm) per subject~     will be taken.~      For subjects with acne rosacea and acne vulgaris, a maximum of two (2) skin biopsies (3 mm)~     per subject will be collected. Biopsies will be performed on either the trunk or the limbs,~     excluding the hands and the feet. The biopsies will be used to develop a method to isolate~     inflammatory cells from the skin. Various protocols will be tested to find the best method.~     No medication will be given to you for this experiment.~   "
99077|NCT02270398|"~     Background Functional community ambulation not only requires a critical level of postural~     control and walking skills, but also the ability to engage in cognitive tasks while walking~     (i.e., dual-task walking) and adapt to the constantly-changing environmental contexts. There~     is evidence showed that dual-task balance and gait performance is significantly impaired~     after stroke. Increasing evidence also suggests that dual-task balance and gait performance~     is useful for predicting falls among individuals with stroke. Considering the high clinical~     relevance of dual-task balance and gait performance, it is essential that stroke~     rehabilitation adequately addresses dual-task deficits. Developing specific dual-task balance~     and gait training to enhance dual-task performance is thus necessary to promote community~     ambulation and reintegration.~      Study Aim The aim of this Introduction Many individuals after stroke continue to cope with~     residual physical impairments after discharge from hospital. One of the major problems~     encountered by people after stroke is community reintegration. Functional community~     ambulation not only requires a critical level of postural control and walking skills, but~     also the ability to engage in cognitive tasks while walking (i.e., dual-task walking) and~     adapt to the constantly-changing environmental contexts. There has been an increasing~     awareness of the importance of dual-task gait performance in community-dwelling individuals~     with stroke in the past few years.~      There is evidence showed that dual-task balance and gait performance is significantly~     impaired after stroke. Increasing evidence also suggests that dual-task balance and gait~     performance is useful for predicting falls among individuals with stroke. Considering the~     high clinical relevance of dual-task balance and gait performance, it is essential that~     stroke rehabilitation adequately addresses dual-task deficits. Developing specific dual-task~     balance and gait training to enhance dual-task performance is thus necessary to promote~     community ambulation and reintegration.~      Study Aim This will be a single-blinded randomized controlled trial (RCT).The aim of this~     study is to examine the efficacy of a dual-task exercise program on cognitive-motor~     interference in balance and walking tasks, balance self-efficacy, participation in everyday~     activities, community reintegration and incidence of falls among individuals with chronic~     stroke.~   "
99078|NCT02270385|"~     This study aims to evaluate the effectiveness of a PU prevention programme for for-profit~     private nursing homes~   "
99079|NCT02270372|"~     This is a two-part Phase 1b, open-label study of ONT 10 administered in combination with~     varlilumab. Two different doses of varlilumab will be studied in combination with the single~     agent recommended dose of ONT 10. Intermediate and/or lower doses of varlilumab or ONT-10 may~     also be studied at the recommendation of the safety monitoring committee (SMC).~   "
99080|NCT02270359|"~     The purpose of this study is to determine the prevalence of plaque disruption and to assess~     the composition of disrupted plaques in patients with myocardial infarction (MI) and~     non-obstructive coronary artery disease (CAD) using optical coherence tomography (OCT).~     Additionally, cardiac magnetic resonance imaging (CMR) will be used to detect myocardial~     abnormalities, which will be correlated to OCT findings to gain insight into the mechanisms~     of MI in patients with non-obstructive coronary artery disease (i.e. open arteries).~   "
99081|NCT02270346|"~     Allogeneic hematopoietic stem cell transplantation (allo-HSCT) causes various toxic effects~     in many body tissues, organs and systems such as immune, cardiovascular, pulmonary,~     gastrointestinal, neuroendocrine and musculoskeletal systems, liver, kidneys and~     skin.Available limited numbers of studies showed that inspiratory muscle weakness in~     allo-HSCT candidates and recipients. Although meta-analysis, systematic reviews and studies~     demonstrated beneficial effects of inspiratory muscle training on several outcomes in~     different disease groups; chronic obstructive pulmonary disease, bronchiectasis and heart~     failure, no published paper reported the effects of IMT in allo-HSC recipients.~   "
99082|NCT02270333|"~     Respiratory muscle weakness results with decreased exercise capacity, worse fatigue, dyspnea~     and quality of life in patients with sarcoidosis. However, no study investigated the effects~     of inspiratory muscle training (IMT), therefore effects of IMT on outcomes in patients with~     sarcoidosis were investigated.~   "
99083|NCT02270320|"~     Background: Promotion of cognitive functions of middle aged and older adults and prevention~     of dementia are important issues in the aging society. In recent years, studies have shown~     that Tai Chi Chuan (TCC) exercise can improve cognitive functions in healthy middle-aged and~     older adults, but not studies have investigated the neural mechanisms. Therefore, the~     purposes of this research project are: (1) to investigate the effects of TCC exercise~     intervention on improving cognitive functions and motor functions in healthy middle-aged and~     older adults; (2) to investigate the effects of TCC intervention on improving the integrity~     of frontostriatal fiber tracts, and areas and intensity of brain activation while performing~     a switching task in healthy middle-aged and older adults.~      Methods: This project used the assessor-blind and randomized control clinical trial design. A~     total of 60 healthy middle-aged and older adults will be recruited, randomly allocated to two~     groups: experimental and control groups. Experimental group will receive a 60-minute exercise~     program, three times per week for 12 weeks. Control group will receive a telephone~     consultation once every two weeks for 12 weeks. All participants will receive clinical~     neuropsychological tests, Cambridge Neuropsychological Test Automated Battery tests, motor~     function tests, diffusion spectrum MR imaging, and functional MRI experiments before~     intervention, and at the end of intervention to realize the changes of cognitive function,~     motor function, integrity of neural tracts, and intensity and regions of functional~     activation while doing switching task of executive function in order to understand the~     cognitive effects and the neural mechanisms of TCC.~   "
99084|NCT02270307|"~     Evaluating the effectiveness of the new protocol which replace the standard immunosuppressive~     therapy with use of MSCs and CY in patients at high risk of relapse.~   "
99085|NCT02270294|"~     The investigators hypothesize that Acute Thai traditional massage will yield beneficial~     effects on cerebrovascular reactivity in ischemic stroke patients.~   "
99112|NCT02269943|"~     The purpose of this study is to evaluate the safety and efficacy of CC-486 in previously~     treated subjects with locally advanced or metastatic nasopharyngeal carcinoma having failed~     one to two previous regimens, including platinum-based chemotherapy. Approximately 51-55~     subjects will be enrolled according to a Simon two-stage design; if the predefined activity~     is met (>4 responses [complete response; partial response {CR/PR}] out of the first 17~     evaluable subjects based on independent radiological assessment), then the study will~     continue to enroll an additional 34 subjects. If < or = 4 responses out of 17 are observed,~     then the study enrollment will be stopped.~   "
99086|NCT02270281|"~     Although EGDT goals appeared to have been achieved, severe derangements of organ perfusion~     were detected by SDF technique.An abnormal microvascular flow index was present in 17% of~     patients in ICU . Microcirculatory alterations are stronger predictors of outcome than global~     hemodynamic variables.Improvement of microcirculatory dysfunction is a big challenge to~     clinician. Dexmedetomidine is a highly selective α2-adrenoreceptor agonist for sedation of~     adult critically ill patients which exhibits sedative and analgesic effects. Recent studies~     suggest that dexmedetomidine to restore adrenergic vasoconstrictor responsiveness in septic~     shock, and prevents alterations of pain rat model intestinal microcirculation Induced by~     surgical stress，even it can reduce the mortality of endotoxemic rats and patients with severe~     sepsis. The investigators will conduct a clinical trial to investigate the effect of~     dexmedetomidine on microcirculatory dysfunction in early septic shock patients with relative~     stable hemodynamics.~      thirty patients with septic shock will be enrolled . After sufficient fluid resuscitation and~     hemodynamic stabilization for 24 hours, these patients who required sedation will receive~     continuous infusion of two dose of dexmedetomidine (infusion rate 0.3 and 0.6 mcg/kg/h) for 1~     hours as needed. The sublingual microcirculation and serum level of catecholamine will be~     examined at preset time points. The vital signs, hemodynamic parameters will be recorded and~     analyzed.~   "
99087|NCT02270268|"~     The purpose of this study is to investigate the effect of pectin, a kind of soluble dietary~     fiber, on clinical symptoms, gut microbiota and the immune status in patients with~     diarrhea-predominant irritable bowel syndrome~   "
99088|NCT02270255|"~     Uterine fibroid embolization (UFE) is now an accepted treatment of uterine fibroids. However~     the procedure is often very painful and, in many centres, patients are admitted overnight~     with PCA pumps for pain control and discharged the next day with heavy pain medications. The~     goal of this study is to evaluate the effectiveness of a superior hypogastric nerve block in~     controlling the pain post-UFE.~   "
99089|NCT02270242|"~     The purpose of this study is to compare the use of ticagrelor alone versus ticagrelor and~     aspirin together. Both ticagrelor and aspirin stop platelets from sticking together and~     forming a blood clot that could block blood flow to the heart. This study will look to~     determine the effectiveness and safety of ticagrelor alone, compared to ticagrelor plus~     aspirin in reducing clinically relevant bleeding and in reducing ischemic adverse events~     among high-risk patients who have had a percutaneous intervention with at least one~     drug-eluting stent. A patient is considered high-risk if they meet certain clinical and/or~     anatomic criteria.~      Up to 9000 subjects will be enrolled at the time of their index PCI. Subjects meeting~     randomization eligibility criteria at 3 months post enrollment will be randomized to either~     ticagrelor plus aspirin or ticagrelor plus placebo for an additional 12 months. Follow-up~     clinic visits will be performed at 3 months, 9 months and 15 months post enrollment.~   "
99090|NCT02270229|"~     The purpose of this study is to develop recommendations to assist in improving the current~     peritoneal dialysis (PD) program in a Hospital in Chinandega, Nicaragua. This project will~     consist of a needs assessment, a review of aggregate quantitative patient data from hospital~     records, and a knowledge, attitudes, and practices (KAP) assessment for medical providers,~     laboratory technicians, patients and primary caregivers. The final report will be used to~     obtain funding for the implementation of the recommendations.~   "
99091|NCT02270216|"~     Aim to study the exercise responses to both static and dynamic exercise in elderly people~     with and without essential isolated systolic hypertension, seeking to identify potentially~     dangerously high responses~   "
99092|NCT02270203|"~     The purpose of this study is to evaluate the long term safety and effectiveness of SI joint~     fusion using the iFuse Implant System in patients with degenerative sacroiliitis (DS) and/or~     sacroiliac joint disruptions (SD).~      Study Design: This study is extended follow-up from two ongoing multicenter prospective US~     clinical trials. All participants have already undergone the surgical procedure of interest~     (SI joint fusion with iFuse Implant System). The two ongoing trials are:~        -  SIFI:( Sacroiliac Joint Fusion with iFuse Implant System) a single-arm trial of patients~          with degenerative sacroiliitis or sacroiliac joint disruption who underwent iFuse~          placement, and~        -  INSITE(Investigation of Sacroiliac Fusion Treatment): a randomized clinical trial of the~          same patient population who underwent either non-surgical treatment or iFuse placement~   "
99093|NCT02270190|"~     The main research question is to see if Percutaneous Tibial Nerve Stimulation (PTNS) can~     improve the symptom of tenesmus in patients with pelvic floor disorders. This includes those~     who have rectal cancer in situ or who are post-rectal cancer treatment and have Anterior~     Resection Syndrome.~      The secondary research questions are to see if other pelvic floor symptoms and quality of~     life improves for this patient group and if levels of anxiety and depression improve for~     these patients.~   "
99094|NCT02270177|"~     Headache is a frequent cause of visits to the GPs office, and the investigators have~     previously shown that this group accounts for about 20 % of patients referred to a general~     neurologic outpatient clinic.~      To our knowledge, no previous study has investigated whether headache consultation through~     telemedicine provides equal health care outcomes compared to regular visit to the~     neurologist. If that's the case, a modern interactive health care system may give simpler and~     cheaper services for patients, saving travelling costs and community expenses. It may~     possibly also lead to reduced waiting lists, earlier diagnosis and treatment.~      This is an open-labeled randomized non-inferiority trial of headache patients referred to a~     neurologic clinic in North-Norway. The aim of this study is to determine whether video~     consultations are non-inferior to regular consultations in diagnosing and treating primary~     headaches. The null hypothesis is that there is no difference in patient satisfaction between~     the two groups. The outcome is assessed 3 and 12 months after the neurologic consultation.~      Participants will be allocated to either a telemedicine consultation or a regular~     consultation at the neurologic outpatient clinic in the University Hospital of North-Norway,~     Tromsø. Both groups will undergo a structured and detailed interview to clarify the diagnosis~     and establish appropriate treatment. To ensure the best possible representation in the~     population, our goal is to include at least 70% of all the referred patients that meet the~     criteria for participation. The randomizations are made through a centralized 8-16 phone line~     to the research-department in Tromsø, at the University Hospital of North-Norway.~      Both primary and secondary endpoints will be assessed in questionnaires sent three and 12~     months after the consultation. In addition, the quality of the physicians` referrals and~     calculations of cost savings by using telemedicine will be evaluated.~      The patients' informed consent will always be obtained before data collection. Patients are~     able to withdraw from the study at any time. Withdrawal will not affect the treatment or~     follow up. Local research ethics committee (REC) has approved the study.~   "
99145|NCT02269514|"~     The purpose of this study is to measure plasma nicotine uptake parameters, physiological~     measures, and subjective effect measures in smokers during and following a single ad libitum~     use of three electronic cigarettes versus combustible cigarettes and nicotine gum.~   "
105757|NCT02183116|"~     To Access the Efficacy and Safety of Meloxicam 7.5mg once daily over a treatment period of 56~     days~   "
99096|NCT02270151|"~     Atrial fibrillation (AF) is the most common arrhythmia and a common cause of stroke. AF can~     be asymptomatic and remain undiagnosed. Both the prevalence of AF and the proportion of~     strokes related to undetected AF increases with ageing. If AF is timely diagnosed and treated~     accordingly with anticoagulants, disabling strokes can be prevented. In order to help~     physicians in diagnosing atrial fibrillation, the MyDiagnostick was developed. It is a CE~     certified device that is safe, user friendly and easy to use. This device is capable of~     detecting or excluding AF within one minute by providing a registration of lead I of the ECG.~      The investigators aim to perform a 2-arm cluster randomized diagnostic trial among patients~     aged 65 years and over who visit the general practice. In total the investigators will~     include 42 general practices of which they randomly assign 21 to the MyDiagnostick arm and 21~     to the control arm. All persons aged 65 years and over who visit the general practice in the~     MyDiagnostick arm will be asked to hold the device every time they visit the surgery during~     one year.~      The number of newly detected cases of AF with the diagnostic screening strategy with~     MyDiagnostick (MyDiagnostick arm) will be compared to care as usual (control arm). Also, the~     number of patients treated with anticoagulants according CHA2DS2-VASc score will be compared~     between both arms. Finally, the investigators will assess the number of major adverse~     cardiovascular events (MACE), intracerebral hemorrhages and other major hemorrhages, and~     all-cause mortality between the arms. End points will be assessed blinded to allocation.~      The investigators hypothesise that the MyDiagnostick improves the diagnosis of atrial~     fibrillation in primary care and with accordingly treatment will reduce adverse outcomes.~   "
99097|NCT02270138|"~     The aims of the study: Main objective of the current study is to decrease sedentary behavior~     and increase physical activity among mothers and their offspring by using music-to-movement~     video program. Primary outcomes of the study are objectively assessed sedentary behavior and~     physical activity time measured both in minutes and as a proportion of measurement time.~     Secondary outcomes of the study are quantity and quality of self-reported screen time among~     mothers and children and motivational quality of music and music-to-movement video.~     Additional secondary outcomes are mother's weight, workability, mental health and mood.~     Specific aim is to study effectiveness of intervention with accelerometer use only or with a~     combination of accelerometer plus music-to-movement video program for mother-child pairs.~      Materials and methods: Participants (mother and child -pairs) of the Movement-to-music video~     program (Moving Sound) -study will be recruited from the cohort of the original Lifestyle,~     counselling and exercise in maternity care (NELLI) -project from 14 municipalities of~     Pirkanmaa area. Participants will be randomized in two groups: accelerometer (ACC) vs.~     accelerometer plus movement-to-music video program (ACC+DVD) groups. Objective measurement of~     sedentariness and physical activity is based on accelerometer. Information on current health~     behavior will be based on intervention questionnaires. In the analysis physical activity,~     sedentary time and body weight of the intervention and control group will be compared.~     Effects of mother's musical (and PA) background and other mediating factors will be analyzed~     separately in subgroup analyses.~   "
99098|NCT02270125|"~     The aim of this prospective study is to evaluate presence and quantity of nano-sized~     particles and interindividual differences in their distribution and elemental composition in~     human nasal mucosa obtained by mucotomy in patients diagnosed with chronic hypertrophic~     rhinosinusitis and to compare the obtained results with control specimen obtained from~     stillborn children.~   "
99099|NCT02270112|"~     Paroxysmal atrial fibrillation can only be diagnosed during episodes when the arrhythmia is~     present.~      The investigators hypothesize that the activation of the atrial myocardium resulting in the~     p-wave of the ecg should display abnormalities in diseased atria which are vulnerable for AF.~   "
99100|NCT02270099|"~     This clinical performance study is being conducted to evaluate the performance of the Aptima~     Herpes Simplex Viruses 1 & 2 assay for detection of herpes simplex virus (HSV) type 1 (HSV-1)~     and HSV type 2 (HSV-2) in swab samples prospectively collected from suspected HSV lesions.~     Specimens collected using swabs from viral transport medium (VTM)collection kits and Aptima~     swab collection kits will be evaluated.~   "
99101|NCT02270086|"~     The investigators have recently developed an innovative optical molecular imaging platform~     (called PRODIGI) based on high-resolution fluorescence and white-light technologies in a~     hand-held, real-time, high-resolution, non-invasive format. PRODIGI offers a non-contact~     means of obtaining instantaneous image-based measurements of diagnostically-relevant~     biological and molecular information of a wound and surrounding skin tissues for the first~     time and could have significant impact on improving conventional wound care, management, and~     guidance of intervention. In preliminary preclinical testing, the investigators have~     discovered that when wounds are illuminated by violet/blue light, endogenous collagen in the~     connective tissue matrix emit a characteristic green fluorescent signal, while most~     pathogenic bacterial species emit a unique red fluorescence signal due to the production of~     endogenous porphyrins. Therefore, with autofluorescence imaging, no exogenous contrast agents~     are needed during imaging, making this approach particularly appealing as a diagnostic~     imaging method for clinical use.~      In the context of this study, PRODIGI is used to assess wound complications in patients~     diagnosed with soft tissue sarcoma and treated with pre-operative radiotherapy. Both pre- and~     postoperative external beam radiotherapy combined with limb salvage surgery have similarly~     high rates of local control in the management of extremity soft tissue sarcoma. The main~     acute side effect associated with preoperative radiotherapy is wound healing complications.~     Wound care overall is a major clinical challenge and presents an enormous burden to health~     care worldwide. The objective of this clinical study is to determine if PRODIGI coupled with~     an optical tracking platform has clinical utility in identifying, quantitatively measuring~     and longitudinally tracking bacterial imbalance on the patient's intact skin surface at the~     location of the surgical resection site for adult patients with lower limb soft tissue~     sarcoma treated with preoperative intensity-modulated radiation therapy and limb salvage~     surgery and, further, to investigate whether this bacterial imbalance is related to~     radiotherapy dose and wound complications.~   "
99113|NCT02269930|"~     The primary outcome of the study is to evaluate the cumulative area under the concentration~     time curve (AUC) over 2 weeks, as measured by AUC from time 0 to 336 hours post dose~     (AUC0-336h), for serum concentrations of BIIB017 and Rebif.~      The secondary outcomes are to evaluate the maximum observed serum concentrations (Cmax) of~     BIIB017 and Rebif and to evaluate the safety and tolerability of BIIB017 and Rebif over 2~     weeks in healthy volunteers.~   "
99114|NCT02269917|"~     The purpose of this study is to demonstrate non-inferiority in efficacy while switching to a~     once-daily single-tablet regimen containing darunavir (DRV)/ cobicistat (COBI)/ emtricitabine~     (FTC)/ tenofovir alafenamide (TAF) (D/C/F/TAF tablet) relative to continuing the current~     regimen consisting of a boosted protease inhibitor (bPI) combined with tenofovir disoproxil~     fumarate (FTC/TDF) in virologically-suppressed (human immunodeficiency virus type 1~     ribonucleic acid [HIV-1 RNA] concentrations less than [<] 50 copies per milliliter~     [copies/mL]) HIV-1 infected participants.~   "
122562|NCT01963234|"~     Implementing a mobile-phone based system for drug use disorders in primary care settings.~   "
99102|NCT02270073|"~     Background: Mindfulness has its origins in an Eastern Buddhist tradition that is over 2500~     years old and can be defined as a specific form of attention that is non-judgemental,~     purposeful, and focused on the present moment. It has been well established in cognitive~     behavior therapy in the last decades, while it has been investigated in manualized group~     settings. Consequently, the demand to investigate mindfulness under effectiveness conditions~     in trainee therapists has been highlighted.~      Methods/Design: To fill in this research gap, the investigators designed the PrOMET-Study. In~     this study, the investigators will analyze the effects of brief, audio-tape presented,~     in-session mindfulness interventions conducted by both trainee therapists and their patients~     at the beginning of individual therapy sessions in a randomized, controlled longitudinal~     design under effectiveness conditions in a total of 30 trainee therapists and 150 patients in~     a large outpatient training center. The investigators hypothesize the mindfulness~     intervention will have positive effects on therapeutic processes and outcome in contrast to a~     progressive muscle relaxation and a treatment as usual group. The investigators will conduct~     multilevel modeling to address the nested data structure.~      Discussion: The study results could provide important practical implications, as they could~     inform ideas on how to improve clinical training of psychotherapists that could be~     implemented very, as there is no need for complex infrastructures or additional time~     concerning these brief, in-session mindfulness interventions that are directly implemented in~     treatment sessions.~   "
99103|NCT02270060|"~     The purpose of this research study is to:~        1. Investigate the effects of a single 20-minute music therapy intervention with a music~          therapist on the pain intensity, pain relief, and mood of adult patients with sickle~          cell disease as compared to:~             1. Adult patients with SCD who listen to their preferred music for 20 minutes without~               the presence of a music therapist (music listening group)~             2. Adult patients with SCD who receive standard care alone (control group)~        2. Determine the feasibility (delivery, acceptability, and usefulness) of the music therapy~          intervention for pain management~   "
99104|NCT02270047|"~     A 4 week double blinded parallel design with an intervention condition and a control~     condition will be employed. After having completed screening procedure and a baseline test~     day, participants will be randomized to either intervention or control condition. In the~     following 4 weeks, the participants will have to consume the distributed food product daily~     before completing another test day.~   "
99105|NCT02270034|"~     This multicenter, open-label, phase Ib trial aims to assess the safety and activity and~     safety of crizotinib (in combination with radiotherapy and temozolomide) in adult patients~     with newly diagnosed glioblastoma.~   "
99106|NCT02270021|"~     The goal of this study is to prevent over screening and over treatment of young women for~     cervical precancers, which can result in psychological distress and has been associated with~     future risk of premature deliveries. Current national guidelines recommend that routine~     screening be performed at less-frequent intervals and that excisional cervical therapies are~     discouraged in young women. The objectives of this study are to examine physician- and~     patient-based interventions designed to decrease over screening and over treatment by~     increasing adherence to US guidelines for women under 30 years.~   "
99107|NCT02270008|"~     Anal incontinence affects up to 20% of gravid women during and immediately after pregnancy.~     It can lead to embarrassment, poor self-image, lifestyle changes, in addition to poor hygiene~     and increased risk for genitourinary tract infection. These women suffer from a combination~     of loss of fecal and/or flatal control, with increasing frequency as pregnancy progresses.~     Though anal incontinence may subside in the postpartum period, a subset of women will have~     continued anal incontinence or recurrence of anal incontinence with subsequent pregnancies or~     as they age. As of December 2012, only one study has explored the effects of pelvic floor~     muscle training (PFMT) on reducing the development of this condition in the pregnant~     population. However, that study took place in Scandinavia with little demographic correlation~     to a US population and lacked postpartum followup. Although their results showed little~     effect of PFMT on anal incontinence, they recommended further research to be performed prior~     to making definitive conclusions.~      Multiple studies have explored the effects of PFMT on urinary incontinence, and the general~     consensus shows a positive benefit, with a 50% incidence reduction. This study will serve as~     an initial test to explore whether such a positive relationship holds for anal incontinence~     throughout pregnancy and postpartum period for a diverse population. The format will be a~     prospective feasibility trial comprised of a one-time intensive in-person pelvic floor muscle~     training course at the first prenatal visit with at home instructions for continued exercise.~     This group will be compared to a control group which receives a hand-out regarding PFMT but~     no personalized instruction. The progress of the participants and their symptoms of~     incontinence will be monitored during pregnancy and at the postpartum visit using~     standardized validated pelvic floor questionnaires, based on previously designed surveys. A~     sample size of 100 parous women ages 20-35 year old will be randomized to an intervention and~     control or standard therapy group. The investigators' hypothesis is that the intervention~     group will show a 50% risk reduction, similar to the urinary incontinence studies. The~     results of this study will then allow us to design a broader intervention study for which to~     study the effects of PFMT and anal incontinence during pregnancy and the postpartum period.~   "
99108|NCT02269995|"~     This surveillance's objectives are:~        1. Unknown adverse reactions~        2. Incidences of adverse drug reaction~        3. Factors considered to have effect to safety and effectiveness~   "
99109|NCT02269982|"~     This study will develop a first-in-man CTC-based molecular taxonomy of CRPC in the context of~     novel AR-directed therapies, categorize different patterns of resistance in this disease~     setting, and describe their evolution over time and treatment.~   "
99110|NCT02269969|"~     Effective antimicrobial use in the burn population is important since this population is at~     an increased risk for infections during their stay in hospital as a result of their burn~     injury. Tobramycin is an antibiotic that has activity against common burn wound associated~     pathogens, such as Pseudomonas Aeruginosa, and its use is becoming increasingly relevant due~     to the increased incidence of bacterial resistance to currently utilized antibiotics. Once~     daily dosing of tobramycin has been safely and effectively used in the majority of infected~     patients for many years with the proposed benefits of optimized antibacterial activity and~     reduced nephrotoxicity compared to traditional dosing. But, the once daily dosing regimen has~     yet to be validated in the burn population. The purpose of this study is to validate the~     plausibility of once daily tobramycin dosing in the burn population with intent to determine~     a safe, effective, and efficient dosing regimen for this population.~   "
99111|NCT02269956|"~     The purpose of this study is to combine current evidence-based guidelines with adaptive~     leadership (AL) training to assist nursing staff to navigate the delicate balance of~     necessary technical and adaptive work to improve problematic dementia-related mealtime~     symptoms.~   "
99147|NCT02269488|"~     This open-label, single arm, multicenter study will enroll approximately 100 subjects. The~     study is designed to gather the safety and tolerability data in Japanese children 2 to 6~     years of age that would support approval of MEDI3250 in Japan.~   "
99115|NCT02269904|"~     SinoFuan is a kind of Fluorouracil Implants for intraperitoneal chemotherapy during operation~     for treatment of gastric cancer. The indication has bee approved by Chinese FDA. The study is~     a post-marketing study. The subjects will be divided into two groups (Group A and Group B ).~     The subject in Group A will receive D2 radical gastrectomy(R0),Sinofuan during operation and~     6 cycles of Xelox adjuvant chemotherapy.The subject in Group B will receive D2 radical~     gastrectomy(R0),and 6 cycles of Xelox adjuvant chemotherapy. The subject's benefits from~     SinoFuan will be analyzed through comparing 3 years DFS of two groups.~   "
99116|NCT02269891|"~     The purpose of this study is to assess the effectiveness of an herbal combination product~     called Nu Femme, on menopausal symptoms in peri-menopausal women.~   "
99117|NCT02269878|"~     To Study the Effect of Polymorphisms in Fas Ligand Gene Promoter Region (rs 763110) and Fas~     gene (rs1800682) on Platinum-Based regimens used in treatment of malignant pleural~     mesothelioma (MPM)~   "
99118|NCT02269865|"~     Study to focus on the defining and managing the neuropsychological abnormalities of myotonic~     dystrophy and to find out if the neuropsychological abnormalities have any correlation with~     changes seen on Magnetic Resonance Imaging.~   "
99119|NCT02269852|"~     The purpose of this study is to evaluate the immunogenicity and safety of Northern hemisphere~     2013-2014 seasonal trivalent inactivated influenza vaccine in 60 healthy infants aged 6-35~     months old, 60 healthy adults aged 18-60 years old, and 60 healthy seniors aged > 60 years.~   "
99120|NCT02269839|"~     Tinnitus is a common problem which can have a severe impact on quality of life and for which~     there is no truly successful treatment available.~      Repetitive transcranial magnetic stimulation (rTMS) is a method of stimulating the brain~     through the application of a magnetic field in a series of rapid pulses and may be a valuable~     treatment for patients with tinnitus.~      The overall aim of this research is to see if patients with tinnitus benefit from treatment~     with rTMS, and in particular whether one type (continuous theta burst) is more effective than~     other variations of rTMS. Prior to developing a definitive study to address this area a~     feasibility study needs to be performed.~      The proposed feasibility study aims to determine outcomes necessary to enable development of~     a definitive study in the future.~      40 patients suffering with idiopathic tinnitus will be randomised into 2 groups, a control~     group receiving a sham treatment, and an active treatment group receiving theta-burst rTMS on~     5 consecutive days.~   "
99121|NCT02269826|"~     Vulvovaginal irritation due to dryness is a frequent complaint among post- and some~     premenopausal women. International guidelines recommend non-hormonal products as first line~     therapy.~      Efficacy and safety of the medical device Vagisan® Moisturising Cream (VMC), a non-hormonal~     vaginal cream for the treatment of vulvovaginal dryness and Gynomunal Vaginal Gel (GVG), a~     non-hormonal gel should be compared in a 12-week multicentre, open-label, randomised,~     two-period cross-over phase III trial. The hypothesis was that VMC is non-inferior to GVG.~      The primary endpoint was the sum of subjective symptoms of vulvovaginal atrophy (VVA) added~     up over each treatment period. Furthermore, objective symptoms of VVA and adverse effects~     were planned to be assessed. 120 women should be randomly allocated to either of the two~     treatments, each given over a period of 4 weeks.~   "
99122|NCT02269813|"~     PRIMe is a prospective, case-only trial designed to measure the impact of MammaPrint on~     physician chemotherapy intention in the two discordant groups (ET/POOR, CT/GOOD) in stage 1~     and 2 HR-positive HER2-negative breast cancer patients. The design also provides for~     assessment of several important secondary indicators. Eligible patients will have their tumor~     sample analyzed for MammaPrint, BluePrint and TargetPrint. Patients cannot start treatment~     before the MammaPrint result is received and taken into consideration for the adjuvant~     treatment plan.~   "
99123|NCT02269800|"~     The purpose of study is to evaluate the efficacy and safety of Benzalkonium Chloride Solution~     clearing the oral colonized bacterium in hospitalized patients with COPD.~   "
99124|NCT02269787|"~     This research program is intended to improve the treatment engagement and outcomes of~     Veterans who receive inpatient detoxification, and decrease their use of VA inpatient and~     emergency department services. It is intended to increase the use of substance use disorder~     care and 12-step mutual-help groups to benefit recovery, reduce rehospitalizations, and~     reduce costs for VA.~   "
99125|NCT02269774|"~     There is accumulating evidence for obstructive sleep apnea (OSA) as an independent risk~     factor for paroxysmal atrial fibrillation and for high recurrence rates of atrial~     fibrillation after ablation therapy. We have previously shown that simulated OSA triggers~     premature atrial beats (PABs) by acute changes in intra-thoracic pressure. Most episodes of~     atrial fibrillation are initiated by PABs. However, the origin of PABs induced by~     intra-thoracic pressure swings is unknown. This study investigates the origin of premature~     atrial beats induced by intra-thoracic pressure changes that simulate obstructive sleep apnea~     in patients with atrial fibrillation.~   "
99126|NCT02269761|"~     Acute dyspnea (shortness of breath) is a common complaint for patients presenting to the~     Emergency Department (ED). The chest radiograph (CXR) has been the mainstay in evaluating~     patients with shortness of breath and often provides the timely diagnosis of pneumonia,~     pneumothorax, pulmonary edema, among other primary diseases of the lung. There are~     limitations with chest radiograph such as large body mass (e.g, obesity) and patient~     positioning. On occasion, chest radiography findings are difficult to interpret. Lung~     ultrasonography may offer a means of clarifying ambiguous results.~      The objective of this study to determine the usefulness of point of care lung ultrasound in~     evaluating patients presenting to the ED with shortness of breath, cough and/or wheezing.~   "
99127|NCT02269748|"~     The aim of this randomized-controlled clinical trial is to compare the patient morbidity and~     root coverage outcomes of a sub-epithelial connective tissue (SeCTG) used in combination with~     a coronally advanced flap (CAF) and tunnel technique (TT).~      The primary objective of the study is to demonstrate the superiority in terms of the~     post-operative course and pain of the CAF+SeCTG when compared to the TT.~   "
99143|NCT02269540|"~     The investigators will be looking at MAO-A density before and after seven weeks of treatment~     with an antidepressant and dietary supplement. MAO-A is an enzyme that breaks down brain~     chemicals that regulate mood. MAO-A density is elevated in patients with major depressive~     episodes (MDE) secondary to major depressive disorder (MDD). Many remain treatment resistant~     with common antidepressant treatments and we think it may be due to poor targeting of brain~     pathologies. We want to test if adding a dietary supplement may normalize MAO-A.~   "
99128|NCT02269735|"~     The purpose of Part I of this study is to evaluate the safety and tolerability of intravenous~     (IV) doses of MK-2640 in healthy participants and to obtain preliminary plasma~     pharmacokinetic profiles of MK-2640. The purpose of Parts II and III of this study is to~     evaluate the safety and tolerability of IV doses of MK-2640 and regular human insulin (RHI),~     and to evaluate the pharmacokinetic and pharmacodynamic profile of MK-2640 and RHI in~     participants with type 1 diabetes mellitus (T1DM). Part II will be initiated only if Part I~     general safety, tolerability and other observed data are supportive of progression to Part~     II. Part III will be initiated only if Parts I and II general safety, tolerability and other~     observed data are supportive of progression to Part III.~   "
99129|NCT02269722|"~     The investigators will assess the effect of different times of radial clamp post procedure on~     radial artery occlusion and bleeding.~   "
99130|NCT02269709|"~     The purpose of this study is to compare the liver stiffness, which can be caused by~     congestion and fibrosis in pediatric patients before and after a Fontan heart operation.~      A new form of ultrasound elastography (Acoustic Radiation Force Impulse, or ARFI) will~     measure liver stiffness.~   "
99131|NCT02269696|"~     The purpose of the study is to test the effects of metoprolol on anaesthesia and the need for~     perioperative analgesics in patients undergoing breast surgery. With 12 months follow-up the~     incidence of pain and life satisfaction will be evaluated.~   "
99132|NCT02269683|"~     The present randomized controlled trial evaluates the incidence of R1 resections in patients~     undergoing robotic distal pancreatectomy compared to the laparoscopic technique.~   "
99133|NCT02269670|"~     This phase II trial studies how well everolimus and hormone therapy work in treating patients~     with hormone receptor positive breast cancer that has continued to spread (progressed) or~     returned after a period of improvement (recurred) on everolimus and exemestane hormone~     therapy. Everolimus is a chemotherapy drug that may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Estrogen and progesterone are hormones~     that can cause the growth of breast cancer cells. Hormone therapy may fight breast cancer by~     lowering the amount of estrogen and progesterone the body makes. Giving everolimus with a~     different type of hormone therapy may be an effective treatment for breast cancer in patients~     who progressed on everolimus with exemestane.~   "
99134|NCT02269657|"~     The EOS® imaging system, a new imaging modality which offers low dose, weight bearing and~     full body X-ray imaging, requires a new standing position where patients put their hands and~     forearms on the wall vertically for stability. Although this method provides enough support~     for the patients during the extended X-ray acquisition time, its impact on the postural~     balance and sagittal profile of the spine and sacro-pelvic parameters has not been evaluated.~     The goal of this study is to identify the impact of patients' arm positioning on the sagittal~     profile and postural balance of the patient and subsequently propose a standardized method~     for full spine X-ray acquisition in the EOS® imaging system.~   "
99135|NCT02269644|"~     This study will be a double-blind, randomized, multicenter trial to assess the safety and~     efficacy of a single 1500 mg IV dose of dalbavancin plus a single 500 mg IV dose of~     azithromycin in comparison to an approved antibiotic regimen of linezolid 600 mg every 12~     hours for 10-14 days plus a single 500 mg IV dose of azithromycin for the treatment of~     Community Acquired Bacterial Pneumonia.~   "
99136|NCT02269631|"~     This pilot study is designed to test the effects of a high legume (dried bean) diet on hunger~     and other indicators of health over the course of eight weeks, compared to a more~     conventional healthy diet.~   "
99137|NCT02269618|"~     The aim of this randomized control study is to determine the feasibility and efficacy of an~     innovative multidisciplinary telehealth program in chronic obstructive pulmonary disease~     (COPD) and chronic heart failure (CHF) patients. 120 patients (1:1) will be included in the~     study and followed for 4 months and for additional 2 months of follow-up. The primary outcome~     is to improve tolerance capacity~   "
99138|NCT02269605|"~     Phase I, randomized, double blind, placebo-controlled, dose-finding trial. The trial´s goal~     is to evaluate two different doses of Bryostatin on HIV-1 latency and reservoir in HIV-1~     infected patients receiving antiretroviral treatment.~   "
99139|NCT02269592|"~     Blood cancers occur when the molecules that control normal cell growth are damaged. Many of~     these changes can be detected by directly examining parts of the cancer or cells in blood.~     Several alterations that occur repeatedly in certain types of blood cancers have already been~     identified, and these discoveries have led to the development of new drugs that target those~     alterations. More remain to be discovered.~      Some of these abnormalities include alterations in genes. Genes are the part of cells that~     contain the instructions which tell the investigators bodies how to grow and work, and~     determine physical characteristics such as hair and eye color. Genes are composed of DNA~     letters that spell out these instructions. Studies of the DNA molecules that make up the~     genes are called molecular analyses. Molecular analyses are ways of reading the DNA letters~     to identify errors in genes that may contribute to an increased risk of cancer or to the~     behavior of the cancer cells. Some changes in genes occur only in cancer cells. Others occur~     in the genes that are passed from parent to child. This research study will examine both~     kinds of genes. The best way to find these genes is to study large numbers of people. The~     investigators expect that as many 1000 individuals will enroll in this study.~      This research study is trying to help doctors and scientists understand why cancer occurs and~     to develop ways to better treat and prevent it. To participate in this study the participant~     must have cancer now, had it in the past, or are at risk of developing cancer. The~     participant will not undergo tests or procedures that are not required as part of their~     routine clinical care. The investigators will ask the participant to provide an additional~     sample from tissue that is obtained for their clinical care including blood, bone marrow, or~     tissue sample. The investigators will also ask for a gentle scrape of the inside of their~     cheek, mouthwash or a skin sample to obtain their germline DNA~   "
99140|NCT02269579|"~     To assess the impact of moderate hepatic impairment on cytarabine and daunorubicin~     pharmacokinetics and their metabolites following administration of CPX-351.~   "
99141|NCT02269566|"~     We will perform double-blinded placebo-controlled randomized clinical trial which evaluates~     the efficacy and safety of allergen-specific intralymphatic immunotherapy (ILIT) for~     allergens including Dermatophagoides farinae (Df), Dermatophagoides pteronyssinus (Dp), cat,~     and dog that are sensitized and provoke rhinitis-related symptoms in patients with allergic~     rhinitis.~   "
99142|NCT02269553|"~     The study is an open-label, prospective, multi-center, randomized, two treatment parallel,~     comparison study of the TMJ NextGeneration(TM) and custom-fit occlusal splint in the~     reduction of nocturnal bruxism episodes and monthly migraine episodes in subjects diagnosed~     with sleep bruxism and headaches.~   "
99146|NCT02269501|"~     The purpose of this study is to study the effect of a physical exercise program on patients~     suffering from migraine and co-existing tension-type headache and neck pain. The~     investigators hypothesized that migraine patients are ofte physically inactive because of~     their headache and that they will benefit from a specific exercise program.~   "
99148|NCT02269475|"~     The study is designed to gather the efficacy, safety and tolerability data in Japanese~     children 7 to 18 years of age that would support approval of MEDI3250 in Japan.~   "
99149|NCT02269462|"~     Mother-to-child transmission of HIV (MTCT) during pregnancy and breastfeeding is prevented~     with maternal antiretroviral drugs (ARV) and infant nevirapine post-exposure prophylaxis~     (PEP). However, the pharmacokinetics of certain ARVs is associated with marked~     inter-individual variability. This variability has been associated with single nucleotide~     polymorphisms (SNPs) in genes encoding metabolising enzymes, transporters and transcriptional~     regulators. Pregnancy is also associated with additional changes in pharmacokinetics. The~     resulting sub-therapeutic or supra-therapeutic drug exposures may have serious consequences~     for virological control, MTCT, emergence of drug resistance, and toxicity. Foetal and infant~     exposure to maternal ARV during pregnancy and breastfeeding is believed to play a role in the~     prevention of mother-to-child transmission of HIV (PMTCT). However, such exposures may also~     result in toxicity. For example, efavirenz is contraindicated in children less than 3 years~     old or 10kg but transferred to breastfed babies through breast milk. On the other hand,~     double exposure to nevirapine from breast milk and PEP may also predispose breastfed infants~     to nevirapine-associated toxicity.~      In the proposed study, the influence of selected SNPs in certain drug disposition genes on~     the pharmacokinetics of efavirenz and nevirapine during pregnancy and lactation, as well as~     the level of infant exposure to both drugs through breast milk, will be studied. Mathematical~     models will be developed to predict potential dose optimisation strategies during pregnancy,~     and to predict infant exposure to maternal drugs through breast milk.~   "
99150|NCT02269449|"~     The objectives of this study are to demonstrate the safety and efficacy of the new 6Fr sheath~     (Glidesheath slender; Terumo, Tokyo,Japan ; GSS) compared with the contemporary 5Fr sheath~     (Hydrophilic coating sheath from Terumo; Tokyo, Japan (standard of care ; SOC).~   "
99151|NCT02269436|"~     This is an open-label, follow-on phase 1 study to assess the long-term safety and~     tolerability of continuous i.c.v administration of 4 μg sNN0029/day in patients with ALS who~     previously participated in study sNN0029-003~   "
99152|NCT02269423|"~     The purpose of this study is to test how safe the vaccine is in humans and how well it makes~     the human immune system cause an immune- or defense-response to Ebola virus. This vaccine~     will be studied at different doses.~   "
99153|NCT02269410|"~     The obesity epidemic has grown rapidly in the United States, and is associated with increased~     morbidity and mortality rates. Bariatric surgery (BS) has emerged as the most effective~     treatment for severe obesity. Surgical weight loss (WL) is very significant (~40-50kg) during~     the first 6-12 months after surgery. The adequate amount of dietary protein during the active~     period of surgical weight loss is not known. Dietary protein affects body weight regulation:~     satiety, thermogenesis, energy efficiency and body composition. During diet-induced~     energy-restriction, sustaining protein intake (PI) at the level of requirement (0.8g /kg~     ideal body weight (IBW)/ day) appears to preserve fat free mass (FFM) during active WL. PI~     above requirements (1.2g protein/Kg IBW/ day) results in favorable body composition changes,~     with greater decrease in fat mass and preservation of FFM, but without effecting WL. Dietary~     PI 0.8g/day has been associated with greater satiety and increased energy expenditure (EE)~     during calorie restriction. In this randomized prospective study, the investigators will~     evaluate the effect of PI on nitrogen balance, body composition, EE and satiety in 40 women~     undergoing either Gastric Bypass or Vertical Sleeve Gastrectomy, assigned to high protein~     supplementation (PRO-S), high PRO-S (1.2g /kg IBW/day) or standard- based current guidelines~     -PRO-S (0.8g /kg IBW/day). PRO-S will be supplied for 3 months after surgery. Outcome~     measures including nitrogen balance, body composition changes and satiety will be assessed at~     pre-surgery, and at 3, 6 and 12 months post-surgery. These results will help provide~     evidence-based data on safe and optimal levels of protein supplementation after BS~   "
99154|NCT02269397|"~     The primary goal of this observational study is to establish the accuracy of CNS-specific~     Assay for Recurrent Paroxysmal Events (CARPE) as a diagnostic blood test for epilepsy. The~     target population is patients who have been newly referred to the Penn Epilepsy Center or~     patients who are admitted to HUP for continuous video EEG monitoring. (Subjects without an~     epilepsy diagnosis will be included.) Subjects will be asked to provide consent, agree to~     allow the study team to collect information from their medical record, and to provide at~     least one blood sample.~   "
99155|NCT02269384|"~     The prevalence of chronic pain has been estimated at 30% in the US and these values may under~     report the true prevalence of people who experience long term pain as additional research has~     shown that 73% will have a reoccurrence of symptoms within 12 months of the original injury~     indicating that while the pain and symptoms may resolve, additional impairments or issues may~     underlie the symptoms.~      Biopsychosocial factors such as depression, post traumatic stress, anxiety, pain~     catastrophizing, and negative emotions have been closely linked to pain and can influence a~     patient's pain perceptions. Along these lines, the memory of past experiences and trauma~     potentially play a large role in these biopsychosocial responses. Research is evolving and a~     strong correlation has been established between chronic pain and prior history of trauma or~     abuse and also non-traumatic incidents such as motor vehicle accidents and injuries/surgical~     procedures. This has led to speculation and research that explores how a variety of life~     events may become stimulants for long-term alterations in the processing and manifestation of~     pain and how they may have an enduring impact on physical health outcomes.~      The proposed research will add to the body of knowledge underlying the association between~     pain, memory, autonomic system, and neuromuscular function. The goal of this project is to~     study the relationship between pain memory systems, specifically acute pain, short-term~     memory of pain, and long term pain memory, and their effects upon neuromuscular and autonomic~     system responses in the body.~   "
99156|NCT02269371|"~     Male and female DoD beneficiaries ages 18 years or older, who are referred for a standard of~     care weight loss intervention for treatment of obesity will be recruited. Subjects will be~     randomized into one of two groups receiving either a standard of care weight loss~     intervention plus auricular acupuncture at Shen Men, Point Zero, and Appetite Control~     Point/Hunger Point or receiving a standard of care weight loss intervention plus sham~     auricular acupuncture. Subjects will receive treatment in accordance with their randomization~     group for 12 weeks then have one additional follow up visit at week 24. The following~     measures will be obtained: height, weight, waist circumference, and Body Mass Index will be~     calculated.~   "
99157|NCT02269358|"~     The goal of the present study is to evaluate if addition of methotrexate can restore~     remission after loss of response to infliximab after dose escalation.~      another goal is to evaluate if low dose methotrexate can maintain remission achieved by~     regular dose methotrexate by 6 months.~   "
99158|NCT02269345|"~     The investigators propose to complete a randomized controlled trial to compare battlefield~     auricular acupuncture at five points in right ear and five points in left ear (cingulate~     gyrus, thalamus, omega 2, point zero, and shen men) plus standard of care, versus standard of~     care alone, for symptomatic treatment of stent pain in postoperative ureteral stent patients.~     Male and female DoD beneficiaries ages 18 years or older, who are scheduled for elective~     urologic surgery that would be expected to have the routine placement of a ureteral stent~     (ureteroscopy, ureteroscopy with biopsy, ureteroscopy with laser treatment of a stone, ESWL~     of stone greater than 10mm) will be recruited. Subjects will be followed up at 24 hours post~     surgery, 48 hours, 1 week, 1 month, and 1 month post surgery. The investigators will ask~     subjects to rate their pain level on a 0-10 analogue scale, the investigators will assess via~     the Ureteric Stent Symptoms Questionnaire (USSQ) subjects' urinary urgency, urinary~     frequency, and quality of life. The investigators will ask subjects how many pills they have~     taken for their pain including the quantity and dose to assess a reduction in pain medication~     use.~   "
99159|NCT02269332|"~     The investigators will recruit DoD beneficiaries 18 years or older, that have been referred~     for a screening colonoscopy or polyp surveillance (or had one in the last 2 weeks), and have~     no previous diagnosis of colorectal cancer. They will have a 25 OH Vitamin D level drawn to~     determine if there is an association between the level obtained and findings on colonoscopy,~     or previous findings (if repeating).~   "
99160|NCT02269319|"~     The purpose of this study is to determine whether MRX-I is as safe and effective as Linezolid~     in the treatment of adult patients with acute bacterial skin and skin structure infections~   "
99161|NCT02269306|"~     The purpose of this study is to determine whether Visceral fat area and other criteria~     assessed during initial screening could predict the response to ovulation induction with~     clomiphene citrate (CC) in patients with polycystic ovary syndrome (PCOS).~   "
99162|NCT02269293|"~     The purpose of this study is to test the safety of the investigational drug, selinexor~     (KPT-330), in combination with carboplatin and paclitaxel chemotherapy, where paclitaxel will~     be given at two different dosing schedules and selinexor will be given at two different~     dosing schedules. Carboplatin and paclitaxel chemotherapy is a commonly used therapy for the~     treatment of advanced or recurrent ovarian, fallopian tube, primary peritoneal, or~     endometrial cancer. The investigators want to find out what effects, good and/or bad,~     selinexor has on the patient and the cancer.~   "
99163|NCT02269280|"~     The goal of this clinical research study is to compare how 2 different drugs, decitabine and~     azacitidine, when given on a shorter than standard dosing schedule, may help to control MDS.~     The safety of each study drug given on these schedules will also be studied.~      This is an investigational study. Decitabine and azacitidine are both FDA approved and~     commercially available for use in patients with MDS. Giving these drugs on a different~     schedule than is standard is considered investigational.~      The study doctor can tell you how the study drugs are designed to work.~      Up to 240 participants will be enrolled in this multicenter study. Up to 157 will take part~     at MD Anderson.~   "
99164|NCT02269267|"~     This is a non-randomized, prospective, single-group longitudinal study. The purpose of this~     study is to improve the decision making process used by physicians and patients when they are~     considering stopping their Tyrosine Kinase Inhibitor (TKI) medication.~   "
99165|NCT02269254|"~     The NexGen TKR (Zimmer, Warsaw, Indiana, USA) is a proven TKR design that has reported~     excellent medium and long-term results in clinical studies and in implant registries all~     around the world. As a follow-up of the NexGen TKR, an improved design has recently been~     introduced by Zimmer: The Persona TKR (Zimmer, Warsaw, Indiana, USA) has been used~     successfully in about 20.000 patients, but results from independent clinical studies have not~     been reported yet.~      The objective of this study is to accurately assess and compare migration, kinematics,~     prosthesis placement and patient reported outcomes of two TKR prostheses: the fixed bearing,~     cemented NexGen LPS, a proven design with an excellent clinical track record, and the fixed~     bearing, cemented Persona PS, a new design without clinical data (both designs by Zimmer,~     Warsaw, Indiana, USA). The primary objective is to assess and compare migration of the two~     TKR prostheses (Femoral and Tibial component). The secondary objective is to assess and~     compare clinical data, kinematics, prosthesis placement and patient reported outcome~     measures.~      This study is designed as a single-blind randomized trial between the Persona PS total knee~     prosthesis and the well-established NexGen total knee prosthesis.~      Different sample sizes are used for the different parts of this study:~        -  30 Patients with NexGen LPS prosthesis and 30 patients with Persona PS prosthesis for~          RSA~        -  15 Patients with NexGen LPS prosthesis and 15 patients with Persona PS prosthesis for~          Fluo~      The study population will consist of patients with symptomatic osteoarthritis of the knee~     scheduled for TKR surgery at the Department of Orthopaedics, Leiden University Medical~     Center. Annually 40 TKA procedures are performed in our department, of which about 70% is~     Osteo Arthritis (OA) and 30% Reumatoid Arthritis (RA). We anticipate that inclusion can be~     accomplished within a 2 year period.~      Main study parameters/endpoints are:~        -  Migration, measured by means of RSA.~        -  Prosthesis placement and bone resection measured by means of CT and caliper measurements~          of the resected bone parts.~        -  In vivo kinematics by means of fluoroscopy.~        -  Patient Reported Outcome Measures by means of questionaires.~   "
99166|NCT02269241|"~     To demonstrate the contraceptive efficacy of LF111. To demonstrate the safety and~     tolerability of LF111 and assessment of pharmacokinetics of LF111.~   "
99167|NCT02269228|"~     To investigate the occurrence of dipyridamole associated headaches in healthy subjects using~     a titration scheme or not~   "
99168|NCT02269215|"~     Safety, tolerability and pharmacokinetics of BIII 890~   "
99169|NCT02269202|"~     To assess the pharmacokinetics of midazolam with/without concomitant administration of~     crobenetine~   "
99170|NCT02269189|"~     Safety, tolerability and pharmacokinetics following repeated doses (15-day dosing)~   "
99171|NCT02269176|"~     Using Losartan as a comparator, to evaluate the efficacy and safety of telmisartan in the~     treatment of the mild to moderate primary hypertension patients in China~   "
99172|NCT02269163|"~     A Phase 3, Multinational, Multicenter, Open-Label Study of the Safety, Tolerability,~     Efficacy, and Pharmacokinetics of ProMetic BioTherapeutics Immune Globulin Intravenous~     (Human) 10% in Adults and Children with Primary Immunodeficiency Diseases (PIDD) to assess~     the tolerability, safety, efficacy and pharmacokinetics of ProMetic's IGIV in subjects with~     PIDD. IGIV is intended for the treatment of children and adults with Primary Immunodeficiency~     Diseases (PIDD) who require IgG (Immunoglobulin G) replacement therapy~   "
99173|NCT02269150|"~     The purpose of this study is to see if fecal microbiota transplantation (FMT) will prevent~     the future development of CDI. This is also known as fecal bacteriotherapy or stool~     transplant.~   "
102296|NCT02228343|"~     Can Ayurvedic therapy improve markers of cardiovascular health and cardiovascular risk~     factors in patients with coronary artery disease.~   "
99174|NCT02269137|"~     To characterize the functional outcomes and prognostic factors for convulsive status~     epilepticus (SE) and to further develop and validate a simple and practicable scoring system~     for outcome prediction.~   "
99175|NCT02269124|"~     Unilateral hearing loss (UHL) in children has been demonstrated to have a negative impact on~     quality of life, school performance and behavior. Despite this knowledge, it remains unclear~     how to best manage this common problem. There has been much debate regarding this issue with~     many programs recommending preferential seating in the classroom and use of a~     frequency-modulated (FM) system to amplify the teacher's voice in the classroom (conventional~     measures), and others recommending these accommodations in addition to use of a hearing aid~     for amplification (amplification). There is very limited research to support or refute the~     efficacy of a hearing aid in improving measurable academic, behavioral, or quality-of-life~     (QOL) outcomes in children with UHL. We propose a study evaluating the impact of hearing aid~     use in school-aged children (ages 6-12 years) with mild to moderately severe UHL. In this~     study, subjects will be randomized to receive either conventional measures or conventional~     measures plus amplification. After a three month period, the groups will be reversed, with~     each subject serving as their own control. Outcome measurements will include patient reported~     disease-specific QOL reported by patients, parents, and teachers using validated survey~     instruments at regular intervals throughout the study period.~   "
99176|NCT02269111|"~     This pilot clinical trial studies quantitative magnetic resonance imaging (MRI) at 3 Tesla in~     assessing disease in patients with tumors that have spread to the brain (brain metastases).~     In addition to routine care brain imaging of the brain, this study will include advanced~     multiparametric MRI sequences to measure vascular, cellular, and molecular properties of the~     tumor. Performing extra scans during MRI provides more information about the metastases and~     may better predict treatment response.~   "
99177|NCT02269098|"~     A 4 week prospective, randomized controlled study was carried out to assess the impact of a~     care delivery intervention which focused on blood glucose (BG) management among adults with~     type 2 diabetes presenting to the Emergency Department (ED) with BG > 200mg/dL (11.1 mmol/L).~     The intervention was designed by a multi-disciplinary team of ED physicians and nurses,~     endocrinologists and diabetes educators. The intervention incorporated three components: a~     guideline-based algorithm for diabetes medication management; survival skills diabetes~     self-management education (DSME); and support for health system navigation. The control group~     received usual care per the ED's policies and procedures for management of high blood~     glucose.~   "
99178|NCT02269085|"~     The goal of this clinical research study is to find the highest tolerable dose of carfilzomib~     and ibrutinib that can be given to patients with relapsed or refractory MCL.~      Researchers also want to learn if carfilzomib and ibrutinib can help to control the disease.~      This is an investigational study. Ibrutinib is FDA approved and commercially available to~     treat MCL and chronic lymphocytic leukemia (CLL). Carfilzomib is FDA approved and~     commercially available to treat certain types of multiple myeloma. Giving carfilzomib to~     patients with MCL is investigational. The combination of ibrutinib and carfilzomib is~     investigational. The study doctor can explain how the study drugs are designed to work.~      Up to 35 participants will be enrolled on this study. All will be enrolled at MD Anderson.~   "
99179|NCT02269072|"~     The proposed study is a physiologic investigation of the effects of testosterone on the~     natriuretic peptide system. The hypotheses of the study are that testosterone administration~     will decrease natriuretic peptide levels and salt excretion. The entire protocol is 8 weeks~     in duration.~   "
99180|NCT02269059|"~     This is a two-part dose-finding trial of MK-7680 in participants with Hepatitis C Virus (HCV)~     infection of genotype (GT)1 (Part I) and GT3 (Part 2). The primary hypothesis is that daily~     administration of a safe and well tolerated dose of MK-7680 will produce a decrease in HCV~     viral load.~   "
99181|NCT02269046|"~     The purpose of this study is to evaluate the effect of 12 weeks of acupuncture and~     moxibustion compared with active control, on absolute and percent change from baseline in~     low-density lipoprotein cholesterol (LDL-C) among those with hyperlipidemia.~   "
99182|NCT02269033|"~     The purpose of this study is to assess the efficacy of a patient navigator program that~     uses a trained community lay health worker to assist Hispanic patients in utilizing cancer~     care services. This study is a two part study. The first part of the study consists of a~     retrospective data collection procedure called baseline clinical chart audit of 50 Hispanic~     women over 18 years of age who have had a mammography abnormality classified as BI-RADS 3, 4~     or 5. These data will be drawn from the study clinic's existing records and will serve as~     baseline data for subjects recruited during the course of the study. The second part of the~     study, the intervention group, involves the recruitment of 50 low-income, Hispanic women who~     receive abnormal breast cancer screening results (also classified as BI-RADS 3, 4 or 5) from~     screening services at local community health clinics. Participants will have significantly~     higher compliance rates and significantly shorter time lags and between an abnormal screening~     result, and confirmatory screening tests and commencement of treatment, compared to our~     baseline. The investigators expect at least a 12% increase in after-screening compliance rate~     and a 25% reduction in time lags in the treatment group, in relation to the pre-intervention~     baseline assessment.~   "
99183|NCT02269020|"~     The main hypothesis of this study is that it is possible to make a unilateral selective~     dissection of ganglion levels IIa, III and IV using an endoscopic transaxillary approach via~     the da Vinci robotic system to reduce scarring, while respecting patient safety.~      Feasibility will be assessed by two combinded criteria: 1) performance of the surgical~     procedure respecting the different stages of visualization and dissection of key anatomical~     elements; 2) obtain a minimum of 9 lymph nodes when analyzing pathological evidence of the~     dissection.~   "
99198|NCT02268825|"~     This is a Phase I dose escalation trial to assess MTD of MK-3475 in combination with mFOLFOX6~     followed by a safety expansion open label, nonrandomized trial with MK-3475 at MTD in~     combination with mFOLFOX6 and supplemental celecoxib in 4 cohorts of advanced/metastatic GI~     malignancies (pancreatic, gastro esophageal, colorectal/appendiceal adenocarcinoma and~     biliary carcinoma) to assess response rate, clinical benefit rate, progression free survival~     and overall survival. The safety expansion cohort will assess the effect of the addition of~     celecoxib to patients that do not respond to combination MK-3475/mFOLFOX treatment.~   "
102313|NCT02228122|"~     The purpose of the research is to assess the effects of Aquacel Ag+ Extra dressing on chronic~     wound bacterial biofilms~   "
99184|NCT02269007|"~     Influenza is an acute respiratory disease caused by influenza viruses. There are three types~     of the virus including A, B and C. Both type A and type B viruses can cause acute febrile~     respiratory tract infection, characterized by sudden fever, headache, muscle pain, cough,~     sore throat, nasal congestion and general malaise.~      Influenza can periodically cause worldwide pandemic. For nearly a century, the influenza~     virus had occurred four large variation, causing three world pandemic. Studies have shown~     that since 1957, most of those new variants of influenza virus started in China, which is~     recognized by the world to have high incidence of influenza. At present, trivalent influenza~     vaccines are widely used in China. They only contain two kinds of type A virus antigens and~     one type B virus antigen. But since 2000, two kinds of type B strains (Victoria and Yamagata)~     have caused an alternating cycle in different seasons. Gradually, evolved from the original~     single lineage of influenza B virus B/Yamagata, two distinct antigenic lineages-B/Victoria~     and B/Yamagata have alternately dominated or caused a mix of popular lineage. These two~     lineages have little or nearly no cross-protection. Therefore, trivalent influenza vaccines~     may not cover the popular strains of influenza B virus, whereas quadrivalent influenza~     vaccines will help to simultaneously prevent two kinds of type A viruses and two kinds of~     type B virus.~   "
99185|NCT02268994|"~     a 24-week phase 3, multi-center clinical trial, comprised of a 16-week, randomized,~     double-blind, placebo-controlled period (Randomized Period), followed by an 8-week~     open-label safety extension period, where all subjects receive KRX-0502 (ferric citrate)~     (Extension Period).~   "
99186|NCT02268981|"~     This study will investigate the effects of a reservoir nasal cannula (Oxymizer®) compared to~     a conventional nasal cannula (CNC) in patients with idiopathic pulmonary fibrosis.~   "
99187|NCT02268968|"~     The main purpose of this study is to evaluate the relative efficacy of topical lidocaine on~     reducing pain associated with the application of nasal CPAP in preterm infants~   "
99188|NCT02268955|"~     The aim of this study is to assess the analgesic efficacy of intravenous ibuprofen given in~     the Emergency Department for the treatment of biliary colic. We hypothesize that intravenous~     ibuprofen will provide a clinically significant drop in self-reported patient pain level as~     measured by the visual analog scale.~   "
99189|NCT02268942|"~     This is a prospective, multi-center,single-arm study that will evaluate the thoracotomy~     implant technique in up to 145 subjects implanted via thoracotomy with the HeartWare HVAD~     System and enrolled in the Interagency Registry for Mechanically Assisted Circulatory Support~     (Intermacs®) protocol and database.~      All participating centers are current INTERMACS® sites in good standing and follow the~     INTERMACS® protocol and procedures.~   "
99190|NCT02268929|"~     This study is a German, prospective, multicenter, controlled, cluster-randomized,~     interventional comparative study evaluating the efficacy and benefits of integrated PDM care~     by measuring HbA1c levels in patients with Type 2 Diabetes. Patients will be randomized into~     two groups to use Accu-Chek Smartpix software and Accu-Chek Smartpix device.~   "
99191|NCT02268916|"~     The purpose of the study is to investigate if the investigators can improve physical activity~     and social participation level among Veterans with diabetes.~   "
99192|NCT02268903|"~     Pulmonary Embolism (PE) is a frequent and severe disease with an annual incidence of about~     75000 cases in France and a short-term mortality rate of about 10%. Death is usually related~     to an acute right ventricular (RV) failure due to the increase in right ventricular~     afterload. Treatment of PE with RV failure consists in fluid expansion and thrombolysis in~     case of shock. However several studies suggest that fluid expansion may worsen acute RV~     failure by increasing RV dilatation and ischemia and left ventricular compression by RV~     dilatation. Thus, current guidelines regarding PE treatment remain unclear about the use of~     fluid expansion. In a preliminary study published by our group, we showed that diuretic~     treatment in the setting of PE with RV dilatation is safe and is associated with an increase~     in urine output, a decrease in heart rate and an increase in SpO2 in normotensive patients~     with oliguria. This may be related to the decrease of ventricular interdependence and~     enhancement of both LV and RV function.~      The main objective of the study is to evaluate the 24-hours clinical benefit of furosemide in~     patients referred for acute PE with RV dilatation compared to placebo. The combination of~     urine output and sPESI clinical parameters reflects hemodynamic status. It is relevant as it~     indicates the disappearance of pre-shock symptoms and is therefore associated with a lower~     event risk. Thus, it allows early discharge of the patients from the intensive care unit.~   "
99193|NCT02268890|"~     The purpose of this study is to evaluate the pharmacokinetic (PK-the study of the way a drug~     enters and leaves the blood and tissues over time) characteristics of bortezomib when~     administered intravenously in Taiwanese participants with multiple myeloma (cancer of the~     types of cells normally found in bone marrow).~   "
99194|NCT02268877|"~     The goal of this project is to compare the efficiency of pelvic ultrasounds performed by~     emergency medicine residents and attending physicians to the efficiency of pelvic ultrasounds~     performed by the department of radiology.~   "
99195|NCT02268864|"~     The purpose of this study is to determine the efficacy of a 12- or 24-week treatment regimen~     of simeprevir in combination with daclatasvir, as measured by sustain virologic response 12~     (SVR12), in treatment-naive, chronic hepatitis C virus (HCV) genotype 1b-infected~     participants who have advanced fibrosis or compensated cirrhosis (METAVIR F3/F4).~   "
99196|NCT02268851|"~     This research study will be evaluating the safety and efficacy of a study drug called~     TGR-1202 in combination with a known drug ibrutinib, also known as Imbruvica, as a possible~     treatment for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Mantle~     Cell Lymphoma (MCL) that has come back or that has not responded to standard treatment.~   "
99197|NCT02268838|"~     This is a single-center, placebo-controlled, randomized, ascending dose, double-blind study.~     This study will be evaluating ascending doses of 50, 100, 200, and 400 mg of E6007. This~     study consists of 5 steps, 1 to 5. In steps 1 to 4 (at ascending doses of 50, 100, 200, and~     400 mg), subjects will be randomly assigned in a 6:2 ratio (E6007: placebo) to receive single~     dose of the study drug under fasted condition. Following 3 days of washout period, subject~     will receive the study drug once daily for 7 days starting on the fifth day from the single~     dose administration.~      For step 3 (200 mg), subjects will subsequently have at least 17 days of washout period~     before being escalated to step 5 (200 mg) to receive single dose of E6007 under fed~     condition, to evaluate food effect of the study drug.~   "
99199|NCT02268812|"~     This is an open-label, long-term, multi-centre multi-national postmarketing observational~     registry. The objective of this study is to monitor the long-term efficacy, safety,~     tolerability and quality of life outcomes associated with Prialt and other analgesics~     utilised in the intrathecal management of severe chronic pain.~   "
99200|NCT02268799|"~     The purpose of this study is to determine if there is a rise in serum high sensitivity~     troponin T (a marker for heart muscle injury) following a direct current cardioversion (shock~     therapy) used for patients with atrial fibrillation. This will help us determine if direct~     current cardioversion results in damage to the heart muscles in a sufficient amount to cause~     a rise in high sensitivity troponin T.~   "
99201|NCT02268786|"~     The purpose of the current study is to evaluate the effect of preimplantation genetic~     screening (PGS) by next generation sequencing (NGS) compared to standard morphological~     assessment of embryos on pregnancy rates through a randomized controlled trial (RCT). All~     embryos will be vitrified and a single embryo transfer (SET) will be performed with either~     screened or unscreened embryos depending on randomization.~   "
99202|NCT02268773|"~     To compare the combination of acetylsalicylic acid (25 mg) + modified-release dipyridamole~     (200 mg) bd versus acetylsalicylic acid (75 mg dispersible tablet once daily) in its effect~     on inhibition of thromboxane B2 formation~   "
99203|NCT02268760|"~     To assess the safety, tolerance and pharmacokinetics of 5 mg to 2400 mg BILN 2061 ZW~        1. In rising single doses~        2. With and without a 64 g fat breakfast at one selected dose~   "
99204|NCT02268747|"~     This is an open label, monocentric, uncontrolled phase II trial with Dacomitinib, a pan-HER~     inhibitor, in unresectable or metastatic skin SCC.~      HER2 expression is common in skin SCC, being reported with high rates, even if in small~     studies.~      Coexpression of EGFR, HER2 and HER3 is present in skin SCCs but not in normal skin and it~     could be associated with the malignant phenotype. In this frame Dacomitinib could play a role~     in the increase of the response rate.~   "
99205|NCT02268734|"~     Vandetanib has been approved for patients with unresectable and/or metastatic medullary~     thyroid cancer (MTC) by the Food and Drug Administration, by the European Medicines Agency~     and, very recently, it has been licensed also by the Italian Regulatory Agency (AIFA) for the~     use in Italy. Vandetanib is an orally tyrosine kinase inhibitor (TKI) of vascular endothelial~     growth factor receptor (VEGFR), epidermal growth factor receptor (EGFR), and RET signaling.~      Circulating microRNAs levels could be influenced by the treatment procedures and we~     hypothesize that a TKI therapy could influence the levels of circulating miRNAs as well.~      Aim of this project is to seek non-invasive molecular markers potentially useful as~     prognostic tools for metastatic MTC patients.~   "
99206|NCT02268721|"~     The research and Innovation program Food'n'Go - Empower aims to develop, test and implement a~     health technology solution for involvement and increased empowerment of elderly patients and~     their relatives. The focus is on frequent issues for this group of patients, in the first~     phase focusing on nutrition and physical activity. Later, the solution will include pain~     management, management of sleep problems, management of medication, prevention of confusion~     and coordination of the treatment and care course across sectorial borders. The technology is~     a tablet-computer, operated by the patient by means of a number of app-like software~     applications.~      The program received in the summer of 2013 one of the Capital Region OPI funding for design~     and development of the prototype, which is now ready and looking very promising. The next~     step is a pilot feasibility study testing the usability and acceptability as well as effect~     during hospitalisation and at home after discharge. The present study - Food'to'Go~     investigates the intervention in the post-discharge period.~      Aim The overall aim of Food'n'Go research- an innovation programme is to develop, test and~     implement innovative information technology solutions to increase participation and~     empowerment of older patients and their families, in relation to frequent problems during~     hospitalisation and the time after.~      The aim for the substudy Food'to'Go is to test the feasibility and efficacy of ICT-supported~     energy- and protein-enforced home-delivered main and in-between meals on older patients,~     discharged from acute hospitalisation in medical wards. Hereunder:~        -  Test the technology's relevance, suitability, acceptability and ease of use in relation~          to the target group~        -  Test the communication loop between patient and kitchen, and relatives external access~          to the related website~      Welfare and health technologies are often directed at solving problems and meeting the needs~     of society's most vulnerable groups, often not familiar with computers. We will, in addition~     to developing the technological solution, examine user-related barriers and preferences for~     health technology and try to find solutions that can increase older people's possibilities~     for using technology and achieve empowerment. The program incorporates research and~     innovation in an iterative process where research provides answers and solutions to the~     issues arising in relation to the development of the technology (innovation) and the use of~     it.~   "
99207|NCT02268708|"~     Evaluation of post-operative respiratory complications after thoracic surgery for pulmonary~     resection in patients with COPD~      Introduction: Postoperative pulmonary complications following pulmonary resection occur in~     12-40% of cases. Some risk factors such as COPD are well identified. It has been shown that~     COPD patients with a history of frequent exacerbations are more likely to develop~     exacerbations. No study has evaluated the rate of patients called 'frequent exacerbators'~     among COPD patients requiring pulmonary resection and the relations between exacerbations~     history and incidence of acute respiratory postoperative complications.~      The main objective is to determine the frequency of pulmonary postoperative complications~     (atelectasis, acute respiratory failure, pneumonia) following lung resection in COPD~     patients. The secondary objectives are to determine the frequency of extra pulmonary~     postoperative complications and the prevalence of the 'frequent exacerbator' phenotype in~     this population, as well as its relation with the risk of post-operative complications.~      Materials and Methods: This is a prospective, observational, single-center study, of patients~     with COPD hospitalized for elective thoracic surgery in the center of Thoracic Surgery,~     Hôpital Cochin. The inclusion criteria are: male or female aged more than 40 years, permanent~     airflow obstruction as defined by an FEV/FVC ratio < 70% after bronchodilator. Collected data~     will be: COPD symptoms (dyspnea score, exacerbations) by a questionnaire given to the patient~     during the anesthesia consultation, COPD severity scores, comorbidities, per operative data,~     postoperative complications, hospitalization and intra-hospital mortality.~      Perspectives: This work will provide information on the risk of postoperative complications~     in patients with COPD and the influence of the 'frequent exacerbator' phenotype. This will~     help adapting preventive care to the COPD subtype .~   "
99208|NCT02268695|"~     This study evaluates the efficacy of the new docetaxel-cisplatin-cetuximab regimen (TPEx)~     versus the standard platinum-5FU-cetuximab EXTREME regimen as a first-line treatment in~     recurrent and/or metastatic HNSCC. Half of patients will be treated by TPEx regimen, while~     the other half will be treated by EXTREME regimen.~   "
99246|NCT02268188|"~     This pilot clinical trial studies the Harvesting Health Program in improving the diet and~     physical activity level of cancer survivors. Nutrition and physical activity classes and the~     opportunity to harvest fruits, vegetables, and herbs may increase participants' fruit and~     vegetable consumption and physical activity levels. Studying the participation rates and~     changes in participants' eating and physical activity habits may help doctors learn whether~     the program has an effect on participant lifestyle.~   "
99247|NCT02268175|"~     This study is comparing the effectiveness of enzalutamide with or without abiraterone acetate~     for men with high-risk, localized prostate cancer.~   "
99279|NCT02267759|"~     McGrath videolaryngoscopy avoids the use of Magill forceps for nasotracheal intubation,~     thereby reducing intubation time and complications, especially in patients with a difficult~     airway. This study was performed to investigate whether McGrath videolaryngoscopy is superior~     to Macintosh laryngoscopy for routine nasotracheal intubation in expected normal airways, as~     judged by the time to intubation and ease of intubation.~   "
99209|NCT02268682|"~     Kidney transplantation, especially living donor kidney transplant (LDKT), offers patients in~     end-stage renal disease (ESRD) 3 to 17 additional years of life and improved quality-of-life~     compared to remaining on dialysis. Unfortunately, LDKT education in dialysis centers occurs~     inconsistently, especially for minorities and those who are socioeconomically disadvantaged.~      To ensure more informed transplant decision-making, through a previous HRSA grant, Dr.~     Waterman designed the Explore Transplant (ET) education program based on the Transtheoretical~     Model of Behavioral Change. Through a previous trial, an earlier version of ET, delivered~     face-to-face with patients while they were undergoing dialysis, was shown to increase~     patients' DDKT and LDKT knowledge. However, additional research exploring dialysis providers'~     ability to integrate ET into their care revealed that multiple patient, provider, and system~     barriers limited the degree to which transplant education could be improved.~      Thus, a more comprehensive case-management program to educate patients through external~     organizations may be needed to supplement ongoing transplant education within dialysis~     centers. For this grant, the investigators propose to test the effectiveness of another~     replicable solution for disseminating ET education on a broad scale: Partnering with a large~     health insurance organization to deliver video-guided transplant education supported by~     telephone and mail. The Missouri Kidney Program (MoKP) is a state-wide organization whose~     mission is to serve and educate kidney patients, particularly those who are economically~     disadvantaged. Since MoKP subsidizes the costs of dialysis medication for low-income ESRD~     patients, they operate as an insurance company would with respect to their 1200-patient~     member group. With 900 dialysis patients currently being managed by the MoKP, the~     investigators will conduct an eight-month, group randomized controlled trial (GRCT) where 540~     patients will be randomized to receive: (1) no additional education other than from their~     dialysis center; (2) a video-guided, four-part Explore Transplant (ET) program delivered via~     the internet or mail; or (3) a video-guided ET program with discussion facilitated by a~     telephone case manager.~   "
99210|NCT02268669|"~     The conceptual hypothesis of this study is that primary angioplasty is superior to a combined~     strategy of immediate thrombolysis followed by routine angioplasty in patients with~     ST-segment elevation acute myocardial infarction (STEMI), even with the inherent delay of the~     transfer of these patients.~   "
99211|NCT02268656|"~     Before anethetic induction, infuse dexmedetomidine 0.5 mcg/kg for 2 minutes and after~     injection of lidocaine 30 mg, propofol infusion by using target controlled infusion (TCI)~     pump. Effect site concentraion of propofol start from 5 and changes the concentration as~     previous response to i-gel insertion as up and down methods~   "
99212|NCT02268643|"~     In the present study, the investigators will screen breast cancer of the Chinese women based~     on ultrasound and aim to compare the risk evaluation model of PUMCH model which was~     established by our previous work with other risk models.~   "
99213|NCT02268630|"~     This prospective observational follow-up study is designed to assess the long-term outcomes~     after Venous thromboembolism (VTE) and to assess the effect of the new oral anticoagulant~     (NOAC) rivaroxaban on the prevalence of post-thrombotic syndrome (PTS).~      The study will not be testing any formal hypothesis.~   "
99214|NCT02268617|"~     Individuals with Dementia with Lewy Bodies (DLB) and Huntington's disease (HD) experience~     balance and walking problems that lead to falls. Treadmill walking has demonstrated~     improvements in balance and walking and fall risk in individuals with Parkinson's disease~     (PD), suggesting that it may be beneficial for individuals with DLB and HD. In PD subjects,~     changes in gait parameters have been noted after only one treadmill training session. The~     investigators propose a pilot study to investigate the safety, feasibility, and utility to~     improve mobility and fall risk of a single session of treadmill walking in individuals with~     DLB and HD.~   "
99215|NCT02268604|"~     Study to assess safety, pharmacodynamics and pharmacokinetics of BIIB 722 CL~   "
99216|NCT02268591|"~     Aim 1: Determine whether sleep enhances learning across a range of cognitive domains in~     healthy subjects.~      Aim 2: Determine whether low-frequency transcranial stimulation (TCS) delivered during slow~     wave sleep (SWS), compared to sham stimulation, enhances learning outcomes as indexed by a~     complete neuropsychological battery of tests in epilepsy patients and healthy control~     subjects.~      Aim 3: Determine whether low-frequency TCS delivered during SWS, compared to sham~     stimulation, enhances sleep architecture associated with enhanced memory consolidation (ie.~     increased coherence of slow wave activity and increased frequency of sleep spindles).~      Aim 4. Determine whether low-frequency TCS during sleep results in a more distributed memory~     representation, as suggested by increased hippocampal-perirhinal connectivity on fMRI in~     human subjects.~      Aim 5. Determine whether the frequency of interictal activity during sleep in epilepsy~     subjects is associated with the degree of cognitive benefit conferred by SWS.~      These studies will provide critical pilot data on whether non-invasive brain stimulation~     protocols previously tested in healthy subjects can be extended to epilepsy patients for~     potentially therapeutic cognitive benefits.~   "
99217|NCT02268578|"~     Memory difficulty ranks among the most common complaints for patients with temporal lobe~     epilepsy. While these cognitive problems may affect quality of life more than seizure~     frequency, no effective therapy exists. Transcranial Direct Current Stimulation (tDCS) is a~     method of safe, noninvasive, and painless brain stimulation delivering low intensity direct~     current through scalp electrodes to modulate brain activity. Several recently published~     studies demonstrate the enhancement of working memory and mood with stimulation of the~     frontal region of the brain. Furthermore, tDCS has never been reported to have induced a~     seizure. The aim of our study is to determine whether real tDCS can improve memory function~     and mood. The investigators are enrolling patients with well-controlled temporal lobe~     epilepsy who have not undergone brain surgery.~   "
99218|NCT02268565|"~     The main purpose of this study is to learn about the effects of sleep disruption (two days in~     a row where sleep is shortened and disrupted) on inflammation, mood (how you feel), and pain~     processing (your own experiences/perceptions of pain). In this research project, we are~     trying to figure out if we can change the effects of sleep disruption on inflammation, mood,~     and pain. Therefore, we will study whether taking a low-dose aspirin pill every day over 2~     weeks can change how we respond to sleep disruption. For example, does the sensitivity to~     pain (e.g., how intense the feeling of pain is if we put our hand in very hot or very cold~     water) change with sleep disruption, and can low-dose aspirin influence this change. We are~     also interested in seeing how inflammation changes in relation to your own perceived~     experience of pain.~   "
99219|NCT02268552|"~     An open-label, multi-part, first-in-human study of oral branaplam in infants with Type 1~     spinal muscular atrophy. The purpose of this study is to evaluate the safety, tolerability,~     pharmacokinetics (PK), pharmacodynamics (PD) and efficacy after 13 weeks; and to estimate the~     Maximum Tolerated Dose (MTD) of orally administered branaplam; and to identify the dose that~     is safe for long term use as well as that can provide durable efficacy optimal dosing regimen~     in patients with Type 1 SMA.~   "
105605|NCT02185092|"~     The purpose of the study is to examine the hypothesis test that probiotics will reduce the~     frequency of exacerbation in patients with COPD.~   "
99220|NCT02268539|"~     This is a pilot study designed to investigate the effectiveness of the nMARQ Pulmonary Vein~     Isolation system in the treatment of Paroxysmal Atrial Fibrillation (AF) at different~     ablation settings.~      AF is a common condition which causes a fast and erratic heartbeat. There are estimated to be~     50,000 new cases diagnosed per year in the UK. The fast heart beat can cause symptoms such as~     palpitations, lightheadedness, chest pains, shortness of breath and fatigue.~      Catheter ablation is a technique used for the control of AF. In this procedure a catheter (a~     long thin wire) is passed into the chambers of the heart via a large blood vessel in a leg.~     The tip of the catheter can destroy tiny sections of heart tissue that may be the source or~     trigger of the abnormal electrical impulses. One of the challenges of AF ablation is to~     maximize success rates, as such there is currently rapid advances in technology to carry out~     this procedure.~      Different catheters exist which deliver this energy in different ways. This study uses one~     such system to perform this procedure. It is called the nMARQ system for Pulmonary Vein~     Isolation produced by Biosense Webster. Currently this system is used in practice in the UK~     for patients with this medical condition.~      What we seek to research is when ablating what is the optimum setting to perform ablation at.~     There is currently no data to guide best clinical practice in this area.~   "
99221|NCT02268526|"~     This study is designed to test if CSJ148 can prevent HCMV replication after stem cell~     transplantation.~   "
99222|NCT02268513|"~     It has been argued that social relationships are important to health and well-being. This~     study will investigate links between social networks and cardiovascular disease risk factors~     in South Asians, the second fastest growing ethnic group in the US and one with disparate~     rates of coronary heart disease. Identifying and understanding the links between social~     networks and cardiovascular disease is key to the development and testing of family- and~     community-level prevention interventions for minorities.~   "
99223|NCT02268500|"~     A multi-center, prospective, randomized, open-label blinded-endpoint trial in patients with~     heart failure will be conducted; 20 will be assigned to the standard dose vaccine dose and 20~     patients to high dose influenza vaccine. Post-vaccine antibody measurements will be assessed,~     as well as tolerability differences between groups.~   "
99224|NCT02268487|"~     The objective of this project is to assess the occurrence of early improvement within the~     first two weeks of antidepressant treatment and to correlate this improvement with favorable~     therapeutic outcome at the end of the acute and treatment continuation phases (8 and 24~     weeks, respectively).~   "
99225|NCT02268474|"~     A single center prospective, randomized, controlled split face study comparing a 532nm KTP~     laser with a 595nm PDL for the treatment of Erythematotelangiectatic Rosacea and~     Papulopustular Rosacea.~      Subjects will receive up to 3 laser treatments 4 weeks apart and will be followed at 4 to 6~     weeks post-final laser treatment.~   "
99226|NCT02268461|"~     Spasticity is a common complication of stroke affecting quality of life. Spasticity involves~     exaggerated stretch reflexes that create stiffness in muscles with associated loss of motion~     and functional control. Traditional treatments involve range of motion, medications, and~     sometimes surgery. Each of these has its own limitations, which has invited exploration of~     alternative modes of treatment. One such treatment with the potential to benefit spasticity~     is repetitive Transcranial Magnetic Stimulation (rTMS).~      The purpose of this study is to determine whether patients with upper limb spasticity as a~     consequence of a chronic stroke can benefit from stimulation of the non-affected hemisphere~     of the brain with low-frequency (inhibitory) repetitive Transcranial Magnetic Stimulation~     (rTMS), potentially leading to a reduction of spasticity and clinical improvement in upper~     limb function.~   "
99227|NCT02268448|"~     The purpose of this study is to assess the safety and efficacy of oral clonidine in subjects~     with symptomatic atopic dermatitis and to assess the safety and efficacy of oral naltrexone~     in subjects with symptomatic atopic dermatitis.~   "
99228|NCT02268435|"~     The objective of this study is to determine the recommended dose of combination of dovitinib~     and imatinib in phase I study.~   "
99229|NCT02268422|"~     To compare a 2nd generation Buprenorphine Transdermal System (BTDS) patch with a marketed 1st~     generation BTDS patch to confirm that the two are bioequivalent (deliver the same amount of~     drug) and that they equally both stick to the skin over 7 days of continuous wear.~   "
99230|NCT02268409|"~     Study A536-06 is an open-label extension study for patients previously enrolled in study~     A536-04 (ClinicalTrials.gov Identifier NCT01749540), to evaluate the long-term safety and~     tolerability of ACE-536 in adult patients with beta-thalassemia.~   "
99231|NCT02268396|"~     This is an open-label, multi-center study to evaluate the accuracy, reliability and~     functionality of the Glycopyrronium and Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI)~     dose indicator in adult subjects with moderate to very severe COPD over a 4-week Treatment~     Period.~   "
99232|NCT02268383|"~     Study A536-05 is an open-label extension study for patients previously enrolled in study~     A536-03 (ClinicalTrials.gov Identifier NCT01749514), to evaluate the long-term safety and~     tolerability of ACE-536 in patients with low or intermediate-1 risk MDS.~   "
99233|NCT02268370|"~     The purpose of this study is to find out how to increase the potential for achieving an~     operational cure from chronic myeloid leukemia. An operational cure is a state in which a~     person does not require further treatment, although there may be some remaining cancer cells.~     Patients would normally remain on a TK inhibitor indefinitely within a standard of care~     setting for chronic myeloid leukemia. Within this clinical trial, patients will discontinue~     their TK inhibitor prematurely. If any signs of progression are identified, dasatinib will be~     introduced.~      This research is being done because dasatinib has been shown to achieve a greater response in~     a much higher proportion of patients as compared to imatinib. Dasatinib is approximately 300~     times more potent than imatinib, and it is possible that a greater response can be achieved~     by dasatinib than by imatinib.~   "
99234|NCT02268357|"~     Randomized, placebo-controlled, double-blind, parallel group clinical trial evaluating the~     anxiolytic effects of propranolol on fear of wisdom tooth removal. It is hypothesized that,~     compared to placebo, perioperative oral propranolol reduces dental trait anxiety at 1 month~     follow-up after wisdom tooth removal.~   "
99280|NCT02267746|"~     The purpose of this study is to compare the safety and therapeutic equivalence of a generic~     tazarotene foam 0.1% and the reference listed Fabior™ (tazarotene foam, 0.1%) in the~     treatment of acne vulgaris.~   "
99235|NCT02268344|"~     Introduction: Shoulder pain and dysfunction is common after oncologic neck dissection for~     head and neck cancer (HNC). These symptoms can hinder postoperative rehabilitation and oral~     hygiene, activities of daily living (ADLs), and return to work after treatment. Due to the~     rising incidence of Human papillomavirus (HPV)-associated oropharyngeal cancer, patients are~     often diagnosed in the 3rd or 4th decade of life, leaving many potential working years lost.~     Brief electrical stimulation (BES) is a novel technique that has been shown to enhance~     neuronal regeneration after injury through a brain-derived neurotrophic growth factor~     (BDNF)-driven molecular pathway. The aim of this study is to examine the utility of~     intraoperative BES in prevention of shoulder pain and dysfunction after oncologic neck~     dissection.~      Methods: All adult patients with a new diagnosis of HNC undergoing surgery with neck~     dissection including Level IIb and postoperative radiotherapy will be enrolled. Patients will~     undergo intraoperative BES after completion of neck dissection for 60 minutes continuously at~     20 Hz with an intensity of 1.5 times the motor threshold. Postoperatively, patients will be~     evaluated using the Constant-Murley Shoulder Score, a scale that assesses shoulder pain,~     activities of daily living (ADLs), strength, and range of motion. Secondary outcomes measured~     will include scores on the Oxford Shoulder Score, the Neck Dissection Impairment Index~     (NDII), and the University of Washington Quality of Life (UW-QOL) score. Primary and~     secondary outcomes will be assessed at 1, 2, 3, 6, and 12 months postoperatively. Study and~     placebo groups will be compared using a Mann-Whitney analysis.~   "
99236|NCT02268331|"~     This cluster randomized trial will be the first to specifically evaluate passive versus~     active surveillance methods collection of adverse events (AEs). The evaluation of these~     methods will be performed within the chiropractic healthcare profession, specifically among~     those who treat children. To date there is no mandatory reporting and learning as part of~     their profession. In Europe, a passive (voluntary) reporting and learning online system~     (CPiRLS) has been created and will be utilized in this study for the passive reporting and~     learning arm.~      Manual therapy is the most common intervention provided by the chiropractic profession and is~     the most commonly sought provider-administrated complementary and alternative therapy in the~     United States pediatric population. This study will randomize participating doctors of~     chiropractic who often treat children, to of one of two arms (active vs. passive reporting~     and learning) to evaluate the quantity and quality of AE data collected.~   "
99237|NCT02268318|"~     INVESTIGATE THE EFFECT OF A 12-WEEK CONSUMPTION PERIOD OF SINGLE DOSE A DAY OF A PLANT~     STEROLS-ENRICHED FERMENTED DAIRY PRODUCT ON BLOOD LIPOPROTEIN PROFILE IN JAPANESE ADULTS WITH~     HIGH LDL-C.~   "
99238|NCT02268305|"~     The investigators are studying whether MSM plus standard of care naproxen improves symptoms~     of lower back pain compared to standard of care naproxen plus placebo. Subjects will be~     randomized into 1 of 2 groups. Group 1 will take by mouth 6000 milligrams (mgs) of MSM plus~     standard of care naproxen. Group 2 will take by mouth placebo capsules plus standard of care~     naproxen. Subjects will be instructed to take their study pills for 12 weeks and record on a~     study diary. They will then be followed up for one final visit 4 weeks later. RMDQ, PIQ-6,~     pain level, comprehensive metabolic panel (CMP), complete blood count (CBC) will be assessed~     at 4 week intervals for 12 weeks. Subjects' participation will last 16 weeks.~   "
99239|NCT02268292|"~     The subjects with MetS or type 2 diabetes were enrolled for this exercise-training program.~     All participators underwent an indoor bicycle exercise for twelve weeks. In addition to~     demographic data and biochemical tests were determined after an overnight fasting. Extension~     of muscle strength was detected in the dominant lower extremity.~   "
99240|NCT02268279|"~     Pediatric study to evaluate the safety and pharmacokinetics of solithromycin (oral and~     intravenous) in children ages 0 to 17~   "
99241|NCT02268266|"~     Early verticalization and stepping with the equipment of Hocoma ERIGO during monitoring of~     vital parameters. The device is already CE marked and, for the purposes of the study, will be~     used in accordance with the intended use (after-market clinical investigation).~   "
99242|NCT02268253|"~     This is a non-randomized open label multi-center study. Patients with high-risk~     myeloproliferative neoplasms (systemic mastocytosis [SM], advanced symptomatic~     hypereosinoophic disorder [PED], myelofibrosis [MF], and chronic myelomonocytic leukemia~     [CMML]) will be treated with SL-401, which will be administered as a brief intravenous~     infusion for 3 consecutive days initially every 21 days for 4 cycles; every 28 days for~     cycles 5-7; then every 42 days. Stage 1 will consist of a period in which several doses of~     SL-401 are evaluated. The Stage 2 portion will enroll up to 18 patients with each of the 2~     myeloproliferative malignancies: MF and CMML. In entirety, the Stage 2 portion will consist~     of up to 36 patients who will be treated at a maximum tolerated dose or maximum tested dose~     in which multiple dose-limiting toxicities are not observed (identified in Stage 1).~   "
99243|NCT02268240|"~     The proposed study is a pilot randomized trial of a stepped collaborative care intervention~     designed to decrease post-concussive symptoms and improve post-injury functioning among~     sports-injured youth aged 11-17. Participants with persistent post-concussive symptoms~     (symptoms persisting at least two months post-injury) will be recruited from Seattle~     Children's Hospital departments of sports medicine and rehabilitation medicine. Consent and~     assent will be obtained in-person. Participants will be randomized to receive either the~     stepped collaborative care intervention, or treatment-as-usual. Participants will be assessed~     on a range of symptoms and areas of functioning at four time points: 0 months, 1 month, 3~     months, and 6 months after enrollment. The primary hypothesis is that the intervention group~     athletes, when compared to usual care control group athletes, will demonstrate clinically and~     statistically significant reductions in postconcussive, anxiety, and depressive symptoms over~     the course of the 6-month study. Secondary analyses will assess the impact of the~     intervention on functional impairment including missed school days and other academic~     outcomes. Exploratory analyses will examine MRI findings that are characteristic of~     postconcussive neuropathology, if available in medical record, as predictors of treatment~     responses.~   "
99244|NCT02268214|"~     The purpose of this study is to determine if adding dapagliflozin to insulin is a safe and~     effective therapy to improve glycemic control in patients with type 1 diabetes.~   "
99245|NCT02268201|"~     KTx recipients receiving cyclosporine-based immunosuppressive therapy, and in the opinion of~     the investigator would benefit from switch to a tacrolimus-based immunosuppression, will~     switch the immunosuppressive therapy to a tacrolimus-based one. Efficacy and safety of~     patients will be observed for 52 weeks.~   "
99248|NCT02268162|"~     This study evaluates the value of different bronchoscopy combination for diagnosing~     peripheral pulmonary lesions suspected to be cancer. One-third of participants will receive~     routine bronchoscopy, while one-third of participants will receive bronchoscopy combined with~     a guiding equipment and the other one-third of participants will receive bronchoscopy~     combined with two or more guiding equipments. These guiding equipments include virtual~     bronchoscopic navigation(VBN), endobronchial ultrasonography with a guide sheath(EBUS-GS) and~     fluoroscopy.~   "
99249|NCT02268149|"~     Study to evaluate the effect of multiple doses of BIIL 284 BS on the pharmacokinetics of a~     single dose of prednisone~   "
99250|NCT02268136|"~     The objective ot the present study is to obtain information about safety, tolerability and~     preliminary pharmacokinetics of BIII 890 CL after single intravenous administration of~     increasing doses in healthy male volunteers.~   "
99251|NCT02268123|"~     The purpose of this study is to determine if sperm DNA fragmentation is associated with in~     vitro fertilization (IVF) outcomes when euploid embryos are transferred.~   "
99252|NCT02268110|"~     The purpose of this study is to determine the effect of two different physiotherapeutic~     interventions (exercise therapy and/or abdominal binding) on the signs and symptoms of~     diastasis recti in post-partum women.~   "
99253|NCT02268097|"~     The aim of this prospective, randomized study was to compare the clinical and radiological~     results of free-hand technique and resection guide technique for preparing patella during~     total knee arthroplasty.~   "
99254|NCT02268084|"~     The purpose of this study is to establish the efficacy of Magnetic Resonant Therapy in~     treating Post Traumatic Stress Disorder in Veterans.~   "
99255|NCT02268071|"~     The STOP-Trial is a prospective multicenter nonrandomized open study on grade I hypertension,~     performed by General Practitioners.~      The main purpose of the study is to determine the factors associated with the rate of~     patients remaining normotensive one year after stopping their antihypertensive monotherapy or~     low dose dual therapy:~        -  white coat hypertension~        -  primary diagnosis by home blood pressure measurements (HBPM) /ambulatory blood pressure~          measurements (ABPM) /clinical measure~        -  initial blood pressure level~        -  compliance~        -  therapeutic class versus others~        -  age~        -  gender~        -  weight variation~        -  modification of lifestyle~        -  concomitant treatments and associated substances~      The primary endpoint will be the rate of normotensive patients at one year (i.e. HBPM values~     <135/85 mmHg).~   "
99256|NCT02268058|"~     Concussions and headache are a significant problem for children and athletes. While headache~     generally resolves within 7-10 days; a significant proportion of children, 72-93% experience~     prolonged headache as a symptom of Post Concussion Syndrome (PCS). The prevailing clinical~     view is that mild head injuries resolve with little chance of complications. However, the~     reality is quite different. Concussion in children presents with a range of severity and~     results in both short and long-term physical, cognitive, emotional and behavioural sequelae~     known as PCS with varying times to resolution. To date there are no specific treatments for~     headache pain related to concussion. Physical and cognitive rest is the mainstay of initial~     concussion management.~      The number of children presenting to ED's with a history of concussion and headache is~     increasing. Presently there are no evidence based guidelines available to guide the medical~     team to effectively and consistently manage their headache. Our present standard of care is~     based on the CANCHILD concussion guidelines outlining the child's return to school and~     activity. Yet, our present standard of treatment is compromised and somewhat~     counterproductive if we are not treating the child's headache pain.~      Our pilot study ' An Open Label Randomized Control Pilot Study Examining Treatment of~     Headache In The Post-Concussive Youth' showed that routine administration of oral analgesia~     improves the child's headache symptoms and helps with school re-entry one week post injury,~     compared to a standard care group defined as non routine administration of pain medications.~   "
99257|NCT02268045|"~     Study of RTXM83 plus CHOP chemotherapy versus a rituximab plus CHOP therapy in patients with~     Non Hodgkin's lymphoma The primary endpoint of the investigation is to determine if the~     response rate obtained with RXM83 combined with CHOP is non inferior to the response rate~     obtained with reference rituximab combined with CHOP The present study is a non inferiority~     trial and the study hypothesis is the following: H0: pc ≥ pe + δ vs. H1: pc < pe + δ where,~     pe: proportion of successes in the experimental group (RTXM83+CHOP) pc: proportion of~     successes in the control group (Reference Rituximab+CHOP) Type I error: the difference pc-pe~     is less than δ when in fact the difference is greater than or equal to δ ie, the~     investigators choose the experimental treatment when the control treatment is actually~     substantially better.~      Type II error: the difference -pe is greater than or equal to δ when it is actually lest than~     δ ie, the investigators choose the control treatment when the experimental treatment is~     essentially just as good.~   "
99258|NCT02268032|"~     Evaluate the effect of continuous administration of DHEA or other androgenic agents on~     ovarian reserve markers in women with diminished ovarian reserve (ROD), such as antral~     follicle count and AMH concentrations.~   "
99259|NCT02268019|"~     A comparison between the two hemostatic methods of hypospadias repairing operation, in terms~     of early and mid-term (up to 6 months) failure rate (wound dehiscence and urethral stricture~     needing reoperation) between the two groups: Group A) diluted Epinephrine injection, Group B)~     tourniquet application in children~   "
99277|NCT02267785|"~     The aim of this application is to compare and elucidate the effects of skill-based versus~     aerobic exercise versus control on mild cognitive impairment (MCI) of the executive function~     (EF) subtype in Parkinson's disease (PD); we hypothesize that skill-based exercise will~     result in the greatest improvement in EF and lead to modification of underlying neural~     substrates.~   "
99278|NCT02267772|"~     Purpose: To determine if IV acetaminophen can 1) decrease pain in pregnancy women, 2)reduce~     the amount of opioid use in pregnant women who encounter pain, 3) reduce maternal and fetal~     adverse effects compared to opioids.~      Design: This is a comparative effective trial that is a randomized, controlled trial of IV~     acetaminophen vs. IV morphine in pregnant women.~      Procedures: Women meeting inclusion/exclusion criteria will be randomized to IV acetaminophen~     or IV morphine. The IV acetaminophen group will get up to four standard doses of IV~     acetaminophen during their stay at the hospital. The second group will get up to six standard~     doses of morphine. Subjects will complete a pain scale after medication administration and~     will be asked about any side effects.~   "
99260|NCT02268006|"~     RATIONALE: Using small radiation beamlets of different intensity, IMRT (intensity modulated~     radiation therapy) allows shaping the dose around planning target volume with better sparing~     of normal tissue comparing to 3D conformal radiotherapy. It allows daily delivery of higher~     dose to the tumor with simultaneous integrated boost (SIB), consequently shortening total~     treatment time with potentially better response to treatment. In advanced rectal~     adenocarcinoma excellent response to preoperative radiochemotherapy with complete eradication~     of the primary tumor observed in the histopathological specimen (pathological complete~     response, pCR) correlates with a favorable overall prognosis, so trying to achieve better~     response to preoperative treatment with higher pCR seams feasible.~      PURPOSE:The hypothesis of this study is that in preoperative radiochemotherapy for locally~     advanced rectal adenocarcinoma shortening of the total treatment time with IMRT-SIB to 22~     daily fractions concomitant with capecitabine results in an improved pCR rate from 9%~     (Slovenian trial) to 25%. Secondary objectives are to evaluate pathological down-staging~     rate, histopathological R0 resection rate, sphincter preservation rate, perioperative~     surgical complication rate, local control, disease-free survival (DFS), overall survival~     (OS), late toxicity and quality of life.~   "
99261|NCT02267993|"~     In this single-center, randomized, open-label, crossover, prospective clinical trial, a total~     of 120 AML patients who achieved remission will be randomized into two groups, of 60 cases in~     each group. Each subject is required to undergo two cycles of chemotherapy. At the treatment~     cycle, patients received subcutaneous injection of rhTPO. At the control cycle, rhTPO therapy~     is not given.The safety of rhTPO is evaluated by the monitoring of liver and renal functions,~     blood coagulation, and TPO-neutralizing antibody, and adverse events associated with rhTPO~     treatment are recorded during the study period.~   "
99262|NCT02267980|"~     The investigators evaluate the effects of a subanesthetic dose of ketamine, administered as~     an adjunct to sevoflurane, on duration of seizure activity, hemodynamic profile and recovery~     times during electroconvulsive therapy (ECT) in patients with major depression.~   "
99263|NCT02267967|"~     a multicenter, open-label phase Ib study to determine the safety, tolerability and~     preliminary efficacy of Sulfatinib 300 mg once a day in treating advanced neuroendocrine~     tumors~   "
99264|NCT02267954|"~     The investigators aim to discover if people of different demographic levels are more or less~     attentive to changes in calorie information vs. changes in price information on a restaurant~     menu. The investigators will record whether the calorie/price change was noticed or not, as~     well as how quickly the calorie/price change was noticed, depending on condition and~     individual differences.~   "
99265|NCT02267941|"~     To evaluate epidemiological features of risk factors for aortic dissection (AD) in Chinese~     patients.~   "
99266|NCT02267928|"~     Prevention and early detection of medical problems can greatly reduce health care costs, yet~     time and again, people avoid or ignore services that could help detect medical problems early~     enough to prevent or reduce the severity of potential problems. The investigators seek to~     understand whether the elicitation of symptom admission by patients can predict people's~     perceived risk of the medical condition and voluntary pursuit of medical information.~   "
99267|NCT02267915|"~     1. Primary endpoint: Time to relapse/progression (TTP) after achieving a complete or~          partial response with the (R-GemOxD)-induction therapy~        2. Secondary endpoints:~             1. Quality of response obtained after subcutaneous Rituximab maintenance.~             2. Progression-Free Survival (PFS)~             3. Overall Survival (OS)~             4. Time to Next Therapy (TTNT)~             5. Value of MRD in the disease outcome~             6. Toxicity~   "
99268|NCT02267902|"~     The objectives of this study are to evaluate the absolute bioavailability, and absorption and~     excretion of DA-1229, an IMP in clinical assessment for the treatment of T2DM. The oral and~     IV PK of DA-1229 will also be evaluated. The metabolism of DA-1229 may also be evaluated.~   "
99269|NCT02267889|"~     This study evaluates the effect of catheter ablation of ganglionated plexi (GP) for the~     treatment of adult patients with atrial fibrillation heart arrhythmias. The location of GP~     will be demonstrated by a novel nuclear imaging cardiac camera. 3D images from the cardiac~     camera will guide the GP ablation procedure.~   "
99270|NCT02267876|"~     The purpose of the study is to assess the cumulative disease detection of greater than or~     equal to Cervical intraepithelial neoplasia 2 (CIN2) and greater than or equal to Cervical~     intraepithelial neoplasia 3 (CIN3) in the subjects over 3 years using the subject's HPV~     status and cytology status from the BDS-USHPV baseline results~   "
99271|NCT02267863|"~     This is a phase 1b study to determine the maximum tolerated dose (MTD), dose limiting~     toxicity (DLT) and recommended phase 2 dose of APTO-253 HCl in patients with relapsed or~     refractory hematologic malignancies.~   "
99272|NCT02267850|"~     The aim of this study is to determine the effect of OrthoPulse™, an intra-oral LED (Light~     Emitting Diode) photobiomodulation device, on orthodontic treatment time. This is a~     double-blinded RCT with half the patients receiving treatment from a sham non-functional~     device, serving as controls, and the other half receiving light therapy treatment from a~     functional OrthoPulse™. Orthodontic treatment time for the sham-control patients are compared~     to that of the OrthoPulse™ patients.~   "
99273|NCT02267837|"~     The aim of this study is to determine the effect of OrthoPulse™, an intra-oral LED (Light~     Emitting Diode) photobiomodulation device, on the rate of anterior orthodontic alignment.~   "
99274|NCT02267824|"~     The aim of this study is to determine if extraoral OrthoPulse®, which emits extraoral LED~     (Light Emitting Diode) photobiomodulation (PBM), reduces the time it takes to complete~     orthodontic alignment.~   "
99275|NCT02267811|"~     The purpose of this investigation is to evaluate the clinical effectiveness of the~     OrthoPulse™, an intra-oral LED (Light Emitting Diode) photobiomodulation device, and for~     investigators to evaluate the product in a clinical setting.~   "
99276|NCT02267798|"~     Rehabilitation restores functions and reduces disabilities due to diseases sequelae. The~     relationship between intensity of rehabilitation and clinical outcomes, recently emphasized,~     has generated a great interest for technological high-intensity interventions. However, their~     effects compared to traditional interventions as well the involved biological mechanisms~     remain uncertain. The present Strategic Program aims to predict the treatment efficacy in~     specific rehabilitation profiles, to improve the use of targeted therapies and the~     individual management of patients affected by stroke and to transfer these findings into~     rehabilitative strategies.~   "
99281|NCT02267733|"~     A Pilot Study utilizing high dose trivalent influenza vaccine dose in a booster dosing~     schedule for patients with monoclonal gammopathies stratified by disease status~   "
99282|NCT02267720|"~     The aim of this research is to investigate the survival rate and cost effectiveness of two~     brands of GIC as occlusal-proximal ART restorations. Also the survival rate of the tooth will~     be investigated.~   "
99283|NCT02267707|"~     The purpose of this study is to determine the safety and pharmacokinetic profile of~     nab®-paclitaxel (ABI-007) plus gemcitabine in subjects with advanced pancreatic cancer who~     have cholestatic hyperbilirubinemia secondary to bile duct obstruction.~   "
99284|NCT02267694|"~     This research study is about adding Black Raspberry powder to the treatment regimen of~     patients with ulcerative colitis who are currently in remission and doing well.~   "
99285|NCT02267681|"~     This study aims to compare the effects of fentanyl and alfentanil on postprocedural cognitive~     function in elective endoscopy.~      150 patients will be enrolled in the study. Patients meeting eligibility criteria will be~     randomly allocated to three groups.~      The patients in Group A will be given propofol and alfentanil. The patients in Group F will~     be given propofol and fentanyl. Group P is designated as the control group and the patients~     will be given propofol for sedation.~      Awareness, vital signs and pain will be evaluated. Side effects will be recorded. Patient and~     endoscopist satisfaction will be evaluated.~   "
99286|NCT02267668|"~     The study will monitor outcomes of two interventions to develop a best practice in the~     treatment of mild Traumatic Brain Injury (mTBI).~   "
99287|NCT02267655|"~     The objective of this exploratory study is to examine the utility of high resolution computed~     tomography (HRCT) to measure changes in functional pulmonary imaging parameters as a function~     of short term a) iNO administration and b) nitric oxide (NO) cylinder concentration using the~     investigational medical device INOpulse® DS-C in subjects with WHO Group 3 PH associated with~     COPD on LTOT (Part 1) and in Subjects with WHO Group 3 PH associated with Idiopathic~     Pulmonary Fibrosis (IPF) on LTOT (Part 2 and Part 3)~   "
99288|NCT02267642|"~     To evaluate efficacy, safety, tolerability, and immunogenicity of AbGn-168H administered~     intravenously in patients with active psoriatic arthritis.~   "
99289|NCT02267629|"~     This research study tests whether GLYX-13 - an experimental drug that acts on a brain~     receptor called NMDA - can decrease symptoms of OCD within hours. This is not a treatment~     study. Results from this study will allow doctors and researchers to better understand if you~     and others with OCD may respond to a class of medications that target the NMDA brain~     receptor.~   "
99290|NCT02267616|"~     This study will evaluate LNG-IUD and Etonogestrel (ENG) Implant users who are willing to use~     their contraception beyond the end of the FDA-approved duration. ENG Implant users will also~     be offered to participate in an arm of the study that will randomize them to either keeping~     their implant in or having it removed and replaced with a new implant. Participants will be~     followed for up to three years.~   "
99291|NCT02267603|"~     This phase II trial studies how well pembrolizumab works in treating patients with Merkel~     cell cancer that cannot be removed by surgery or controlled with treatment, or has spread to~     other parts of the body. Pembrolizumab may stimulate the immune system to identify and~     destroy cancer cells.~   "
99292|NCT02267590|"~     Clinical validation of biomarkers determining resistance to BTK inhibition with Ibrutinib in~     Mantle Cell Lymphoma and Chronic Lymphocytic Leukaemia Stage 1.~   "
99293|NCT02267577|"~     The research team has developed an automatic blood pressure monitor to be used for the~     monitoring and diagnosis of pre-eclampsia in pregnant women, particularly in low-resource~     settings where current monitoring is limited.~      90 adult volunteers will be enrolled by researchers at Rice University. The participant will~     be seated in a comfortable chair with arm at heart level. Arm circumference will be measured~     and a blood pressure cuff will be placed on the arm. The cuff will be inflated and blood~     pressure measurements will be taken by a commercially available device and by test monitor.~     Blood pressure measurements from both devices will be recorded. The participant's blood~     pressure will be measured up to 9 times with a waiting period of 45-60 seconds between each~     measurement.~      The results of this study will be used to optimize the blood pressure detection algorithm and~     thus further develop the device.~   "
99294|NCT02267564|"~     This study aims to compare the clinical outcome of Medial PatelloFemoral Ligament (MPFL)~     reconstruction with and without tibial tubercle transfer for recurrent patellar dislocation.~   "
99295|NCT02267551|"~     The objective of this study is to determine whether a group of resident physicians otherwise~     naïve to robotic surgery can demonstrate equal levels of proficiency during their first~     robotic supracervical hysterectomy having received training either with the Mimic dV-Trainer~     or the daVinci Skills Simulator.~   "
99296|NCT02267538|"~     Postoperative delirium (POD) is a frequently occurring complication after cardiac surgery.~     Its occurrence is associated with worse outcomes of patients, including increased morbidity,~     prolonged hospital stay, increased medical cost, and higher mortality. It is also associated~     with long-term cognitive decline and decreased quality of life. However, until recently,~     pharmacological interventions that can effectively prevent its occurrence are still limited.~     The purpose of this study is to investigate whether perioperative dexmedetomidine use can~     decrease the incidence of postoperative delirium in patients undergoing cardiac surgery.~   "
99297|NCT02267525|"~     Study 0099 explores the efficacy and safety of multiple doses of velusetrag in the treatment~     of symptoms in subjects with diabetic or idiopathic gastroparesis. Three dose levels of~     velusetrag will be evaluated and compared to placebo for approximately 12 weeks of therapy.~     In addition, the study will be used to evaluate the psychometric properties of the~     Gastroparesis Rating Scale (GRS), a daily patient-reported outcome (PRO) measure.~   "
99298|NCT02267512|"~     To investigate the efficacy and safety of ATG-F induction regimen using a single dose of~     ATG-F compared with a five-day dose regimen of ATG-F in anew kidney transplant recipients.~   "
99299|NCT02267499|"~     The study involved Information and Communication Technologies (ICT) and more specifically~     computer exercises blended with game activities. It was hypothesized that ICT facilitated,~     game blended combined cognitive and physical exercise improves global cognition when compared~     to a control group; and that the number of sessions within exercising participants predict~     cognitive benefits. In addition, we explored the impact of potential moderators on combined~     exercise-induced cognitive benefits.~   "
99300|NCT02267486|"~     Examine the construct validity, the group discriminant ability, and the inter-rater~     reliability of a novel dementia rating scale (QuQu scale: QUick QUestion scale) candidate for~     the evaluation of patients with Alzheimer Dementia (AD)~   "
99301|NCT02267473|"~     Patients with chronic Hepatitis B who are under oral antiviral treatment for at least 6~     months at study start will be monitored once yearly for kidney function changes within their~     routine outpatient visit. Therefore urine samples will be collected and some additional blood~     test will be done within the routine blood sampling.~   "
99302|NCT02267460|"~     Enrollment will include approximately 30 AA4500 naïve subjects. Subjects will be divided by~     degree of penile curvature and then randomized in a 1:1 ratio to one of the following~     treatment groups:~        -  AA4500 with investigator modeling~        -  AA4500 without investigator modeling~      Each subject will receive 2 injections of AA4500, separated by approximately 24 hours to 72~     hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles.~      Approximately 14 days after the second injection of AA4500, each subject will visit the study~     site and the investigator will assess the subject and instruct the subject on appropriate use~     of the ErecAid® Esteem® Manual Vacuum Therapy System.~   "
99303|NCT02267447|"~     The purpose of this study is to develop, evaluate, and apply a predictive algorithm for~     assessing CVD risk in the community setting: the Cardiovascular Disease Population Risk Tool~     (CVDPoRT).~   "
99304|NCT02267434|"~     Study AFF011 is a randomized controlled parallel Group phase I study to investigate the~     safety and tolerability of two doses of the vaccine AFFITOPE® PD03A given to patients with~     early Parkinson's disease.~      In total 36 patients will be enrolled in 3 independent groups (2 treatment groups, 1 Placebo~     group), each consisting of 12 patients. The patients will be randomized to either receive~     15µg or 75µg AFFITOPE® PD03A formulated with adjuvant or the reference substance without~     active component (Placebo). Over a study duration of 52 weeks, the study participants receive~     4 injections as basic immunization in a 4-weekly interval and 1 boost immunization 36 weeks~     after the first injection. Male and female patients aged 45 to 70 years can participate in~     the trial. 2 study sites in Austria (Innsbruck and Vienna) will be involved.~      AFF011 is part of a project SYMPATH funded by the European Commission~     (FP7-HEALTH-2013-INNOVATION-1 project; N° HEALTH-F4-2013-602999).~   "
99305|NCT02267421|"~     Individuals with Cirrhosis have been shown to have a low aerobic capacity. While supervised~     exercise training has been shown to be an effective intervention to remedy this, there is~     currently no data on home based exercise interventions in this population. This study will~     evaluate the effects of a home based exercise program on the aerobic capacity of enrolled~     early stage liver cirrhosis patients, as well as changes in quality of life, thigh muscle~     thickness, and thigh muscle oxygen consumption.~   "
99306|NCT02267408|"~     Patients on warfarin but with unstable international normalized ratio (INR) will be recruited~     to a randomized trial comparing dosing based on an algorithm (Fearon algorithm, named after~     the mathematician Michael Fearon), which uses historical data to estimate patients'~     sensitivity to warfarin and to dose changes as well as the lag time until a dose adjustment~     takes effect, or to the investigators standard management Main outcome is improvement in time~     in therapeutic range.~   "
99307|NCT02267395|"~     The study will investigate if there are differences in the presence of: (1) prior injury,~     playing patterns, and physical fitness habits; (2) scapular control; and (3) cervical~     neuromuscular control and endurance deficits between musicians with and without current~     playing related musculoskeletal injuries.~   "
99308|NCT02267382|"~     VT-1161 is a novel, oral inhibitor of fungal lanosterol demethylase (CYP51). In vitro and in~     vivo pharmacology studies have demonstrated that VT-1161 is highly active against Candida~     albicans and also non-albicans Candida species that cause vulvovaginal candidiasis. VT-1161~     is highly selective for fungal CYP51, and data suggests that it may avoid the side-effect~     profile that limits the use of commonly prescribed antifungal agents for the treatment of~     recurrent yeast infections.~   "
99309|NCT02267369|"~     The overall objective of this research is to collect data for understanding whether messages~     in online environments impact fitness attitudes and behaviors. In particular, the study aims~     to experimentally examine what features of online social media - promotional messaging or~     peer networks - impact offline fitness measures (such fitness workshop enrollment and~     self-reported physical activity level). The study partners with an existing fitness program~     at a large northeastern university, which provides a 13-week fitness program for graduate and~     professional students at the university. The program begins with a university-run eligibility~     assessment of specific fitness measures for all participants, who win prizes for improvements~     in program participation and health behavior outcomes. The fitness program consists of~     semester-long series of workshops offered through the university's recreation department. The~     randomized trial constructs an online social media platform for the fitness program that~     provides a way to send either promotion health messages or messages about peer activities to~     the online community.~   "
99310|NCT02267356|"~     VT-1161 is a novel, oral inhibitor of fungal lanosterol demethylase (CYP51). In vitro and in~     vivo pharmacology studies have demonstrated that VT-1161 is highly active against~     dermatophytes that cause onychomycosis . VT-1161 is highly selective for fungal CYP51, and~     data suggests that it may avoid the side-effect profile that limits the use of commonly~     prescribed antifungal agents for the treatment of onychomycosis.~   "
99311|NCT02267343|"~     The purpose of study is to evaluate the efficacy and safety of ONO-4538 in patients with~     unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer)~     refractory to or intolerant of standard therapy.~   "
99312|NCT02267330|"~     The aim of this cohort study is to precisely measure patients' exposure to gonadal radiation~     during orthopaedic trauma surgery involving the acetabulum, pelvis, hip, and femur, and to~     apply these findings to a previously described and validated formula to determine the~     increased risk of future adverse health effects to the reproductive organs.~      The investigators null hypothesis is standard of care use of x-ray fluoroscopy during~     treatment of pelvis, hip, and femur fractures will not expose patients to a significant~     gonadal radiation load. Analysis of patients' intraoperative radiation doses by means of a~     previously validated formula will not display a significantly increased risk of adverse~     health events in the reproductive organs.~   "
105758|NCT02183103|"~     Influence of a high fat breakfast in the pharmacokinetic profile of the 7.5 mg meloxicam~     rapid releases tablet~   "
99313|NCT02267317|"~     To determine whether pharmacologic inhibition of Toll-like receptor 4 (TLR4) with eritoran~     for injection (E5564) will reduce inflammation and improve glucose metabolism in insulin~     resistant (obese and T2DM) subjects.~   "
99314|NCT02267304|"~     The aim of the current study is to examine the role of the opioïd system on the cognitive~     parameters of motivation. They are embedded in a conceptual framework of motivation that~     merges decision-making and reinforcement learning theories. Every action is conceived as path~     from one state to another. The different states are associated to different values (positive~     for rewards and negative for punishments), and the different actions to different costs~     (risk, effort and delay). The tasks are designed such that the sensitivity to the state and~     action parameters can be inferred by fitting computational models.The primary objective is to~     characterize the effect of Morphine 0,05mg/kg and Naloxone 10mg on cost accumulation slope,~     assessed in an effort management task, in which participants are asked to squeeze a hand grip~     during 30 seconds at varying level of effort in order to win monetary payoff. Secondary~     objectives are to characterize the effect of Morphine 0,05mg/kg and Naloxone 10mg on other~     cognitive parameters of motivation (assessed with a motivational battery that includes~     rating, choice and learning tasks).~   "
99315|NCT02267291|"~     Cardiologists and intensive care specialists are confronted daily with mechanically~     ventilated patients exhibiting cardiac failure. It is of paramount importance to understand~     the effect of mechanical ventilation on cardiac function and to interpret echocardiographic~     findings correctly in order to provide the patient with the best possible treatment to~     support cardiac and circulatory function. Currently physicians interpret echocardiographic~     findings based on studies that were performed in spontaneously breathing patients. With this~     study, the investigators intend to contribute to the understanding of cardiac physiology in~     patients needing ventilatory support, especially they aim to provide the physiological basis~     for the interpretation of echocardiographic findings in order to improve medical support~     (e.g. fluid resuscitation, vasoactive drugs, ventilation strategy) of ventilated patients~     with impaired cardiovascular function.~   "
99316|NCT02267278|"~     The goal of this clinical research study is to learn if pracinostat, when given in~     combination with ruxolitinib, can help to control myelofibrosis (MF). The safety of this drug~     combination will also be studied.~      This is an investigational study. Pracinostat is not FDA-approved or commercially available.~     It is currently being used for research purposes only. Ruxolitinib is FDA-approved and~     commercially available to treat MF.~      The study doctor can explain how the study drugs are designed to work.~      Up to 25 participants will be enrolled in this study. All will take part at MD Anderson.~   "
99317|NCT02267265|"~     A child's early language environment is pivotal for language development. Disparities in~     early language environments contribute to the gap in school readiness between poor and more~     advantaged children. Ultimately this leads to disparities in students' school achievement and~     economic outcomes. While recent research has highlighted the value of early intervention for~     children in disadvantaged families, most existing interventions begin too late, reach only a~     small proportion of children at risk, and do not capitalize on the critical role that parent~     language plays in a child's educational trajectory. To address this challenge, the~     investigators propose to develop and evaluate a novel language-based, perinatal public health~     intervention, Thirty Million Words Newborn Initiative (TMW-NI). It is proposed that new~     mothers will receive this educational intervention while their babies are undergoing the~     universal newborn hearing screen. The intervention will use video, animation, and interactive~     questions to convey the importance of the early language environment and to illustrate~     strategies parents can use to promote language learning. The investigators will conduct~     formative research with mothers of low socioeconomic status (low-SES) and with healthcare~     providers to inform the content and format of the intervention prototype. Also critical for~     acceptability, the investigators will use an iterative approach to develop the intervention,~     with review of the work-in-progress by the intended audience. To assess feasibility and~     initial efficacy, the investigators will conduct a randomized-controlled trial with low-SES~     mothers during the newborn period. The investigators hypothesize that TMW-NI will positively~     impact parents' knowledge and beliefs about the role of language input for a child's language~     development.~   "
99318|NCT02267252|"~     Investigation of the ability of antibodies from vasectomized men in binding to Y-spermatozoa~     as a possible explanation of the lower sex ratio observed after microinsemination using~     epididymal sperm from vasectomized men.~   "
99319|NCT02267239|"~     The study has the objective to compare two different methodology of application the~     antiseptic on the oral biofilm will be formed during 48h in situ on a specific device. The~     first one using the immersion in the antiseptic solution, as much of the authors did in the~     past. And the second way doing a active mouthwash, as the manufacturer recommends.~      The study will compare two different antiseptic solutions, the chlorhexidine (0.2% Oraldine~     Perio) and the essential oils (Listerine Mentol) with the two different application and~     compared the bacterial vitality, thickness and covering grade between solutions and with a~     basal sample.~   "
99320|NCT02267226|"~     The purpose of the study is to assess the efficacy and safety of Octafibrin for on-demand~     treatment of acute bleeding in subjects with congenital fibrinogen deficiency.~   "
99321|NCT02267213|"~     The purpose of this study is to evaluate the safety and efficacy of TLC388 (Lipotecan) as a~     second line treatment in subjects with advanced Hepatocellular Carcinoma.~   "
99322|NCT02267200|"~     The purpose of this study is to analyse the sensitivity and specificity of circulating~     endothelial cells to predict irreversible pulmonary arterial hypertension associated with~     congenital heart disease.~   "
99323|NCT02267187|"~     This study will examine the impact of the fat grafting procedure on facial appearance and~     quality of life over time by precisely measuring soft tissue volume with CT scans, assessing~     appearance with 2D and 3D photography and standard photography and evaluating quality of life~     through various validated psychosocial measures. This study will be a very important~     evaluation of the effectiveness of this therapy, and will help guide clinicians in applying~     this technique. Additionally, laboratory testing of the injected fat material will be~     performed so that the results may be correlated with clinical outcomes in the future.~      The study endpoints include the analysis of the graft site via study procedures at different~     time points, the comparison of cotton rolling to centrifugation method of autologous fat~     grafting, as well as the correlation of cell behavior of the laboratory assays with clinical~     outcomes.~   "
99324|NCT02267174|"~     The HATRICC study will use mixed methods to implement a standardized process for operating~     room to intensive care unit handoffs that is accepted and sustainably used by perioperative~     clinicians.~   "
99325|NCT02267161|"~     The purpose of this study is to assess the neurological development at three years of age of~     children born after prenatal diagnosis of isolated agenesis of the corpus callosum.~   "
99326|NCT02267148|"~     Non-alcoholic fatty liver disease (NAFLD) is a common disorder, affecting ~30% of people in~     the general population and up to 96% of obese individuals. Variations in several genes have~     been found to be associated with fatty liver, but these associations only explain a small~     percentage of the risk, and further studies are needed. In many cases NAFLD does not cause~     serious side effects, but in some individuals it progresses to scarring or hardening of the~     liver, liver failure, and cancer.~      The purpose of this research study is to determine if individuals who carry certain genetic~     variations in a gene related to bile and choline metabolism have an increased risk of fatty~     liver progressing to fibrosis, or scarring of the liver. This study will also use a new,~     non-invasive method called the FibroScan® to measure liver fat and liver stiffness. The~     FibroScan® device is FDA approved for use to measure liver stiffness, but not for the liver~     fat measurement. However, the FibroScan® instrument is considered a non-significant risk~     device. Since its induction in Europe and worldwide in 2003, there have been no adverse~     effects reported with this device.~   "
99327|NCT02267135|"~     This study will assess the efficacy and safety of secukinumab compared to placebo in adult~     patients who have moderate to severe scalp psoriasis that is poorly controlled by current~     psoriasis treatments.~   "
99328|NCT02267122|"~     The patients were randomized into 3 groups: those patients undergoing a ionic~     silver-containing dressing (ISD) (Group 1), those undergoing a Mupirocin ointment application~     (MOA) (Group 2) and those using a conventional dressing (Group 3) in the surgical wound after~     finishing an elective colorectal surgery.~   "
99329|NCT02267109|"~     Ebola virus causes an infection known as Ebola virus disease (EVD). This is generally a~     severe disease which can also lead to death. The 2014 outbreak of EVD in West Africa is the~     largest ever. Researchers want to develop a vaccine to prevent Ebola infection. It is~     impossible for someone to get an Ebola infection from this vaccine.~   "
99330|NCT02267096|"~     In 2011, the National Lung Screening Trial (NLST) reported that lung cancer mortality was~     reduced by 20% with spiral computed tomography (CT) compared to chest X-ray. It is estimated~     that 8 million people in the US are at high risk for lung cancer and that lung screening~     could prevent 12,000 deaths annually. Cost effectiveness models suggest that concurrent~     smoking cessation programs will be essential in order to realize the full benefit of~     screening. However, there are no clinical guidelines or evidence-based cessation protocols~     with demonstrated effectiveness in this setting. The investigators are addressing this gap by~     rigorously testing whether two scalable and pragmatic interventions can significantly boost~     intention to quit and cessation rates.~   "
99331|NCT02267083|"~     This study will assess the safety and efficacy of GPX-150 administered intravenously every 3~     weeks in the treatment of patients with soft tissue sarcoma.~   "
99332|NCT02267070|"~     This is a randomized controlled 6-month trial of the efficacy of a novel intervention~     combining neuroplasticity-based cognitive training with aerobic exercise, compared to the~     same systematic cognitive training alone. The primary treatment targets are overall cognitive~     deficit level and independent living skills. The investigators hypothesize that combining~     neuroplasticity-based computerized cognitive training and neurotrophin-enhancing physical~     exercise will produce large cognitive and functional improvements, even relative to cognitive~     training alone. Adding aerobic exercise to a cognitive training program will have the~     additional benefit of helping to ameliorate medication side effects, reduce the risk for~     developing metabolic syndrome, and help to prevent the deterioration in physical health that~     usually follows the onset of schizophrenia and its pharmacologic treatment. The investigators~     target the period shortly after a first episode of schizophrenia to maximize the~     generalization of cognitive improvement to functional outcome, before chronic disability is~     established.~   "
99333|NCT02267057|"~     The purpose of this study is to determine whether pain treatment can reduce symptoms of~     depression in patients suffering from dementia and depression. Depression is commonly~     diagnosed in patients with dementia. If the investigators find a reduction in depressive~     symptoms when pain treatment is applied, this will support the hypothesis that undiagnosed~     pain may present itself as depression in patients with dementia.~   "
99334|NCT02267044|"~     Shoulder replacement surgery is recognized as having the potential to cause a considerable~     amount of postoperative pain. Adequate management of pain after surgery is necessary not only~     to improve the patient's wellbeing but also to facilitate recovery. Several regional~     anesthesia techniques are available to combat postoperative pain in the shoulder replacement~     surgery patient, however, which method provides superior pain relief remains unknown. The~     purpose of this study is to examine the effectiveness of a continuous interscalene block~     versus a single shot interscalene block for postoperative pain relief in the shoulder~     replacement patient.~      Patients undergoing shoulder replacement surgery will experience more effective pain relief~     with a continuous interscalene block versus and single shot interscalene block.~   "
99335|NCT02267031|"~     Abdominal surgery commonly requires perioperative relaxation and therefore controlled~     mechanical ventilation. However, respiratory support can be associated with minor, yet~     clinically significant changes in blood gas content. The inadvertent hyperoxia (excessively~     high oxygen) and/or hypocapnia (excessively low carbon dioxide) can result in transient~     changes in cerebral blood flow and cognitive impair.~   "
99348|NCT02266862|"~     Purpose: The purpose of this study is to evaluate the location within the renal artery of~     maximal angular displacement before and after fenestrated endovascular aortic repair (FEVAR)~     using CT with end-inspiration and end-expiration CT images before and after repair. Then, the~     renal artery segment with maximal angular displacement on each will be located and any~     changes described.~      Participants: There will be 30 subjects recruited from UNC Hospitals.~      Procedures (methods): For this study, patients will receive an additional CT sequence~     (end-expiration CT), which will be compared with the standard of care end-inspiration CT to~     calculate angular displacement and the distance from the aorta.~   "
106650|NCT02171442|"~     The aim of this study were to investigate the metabolism and pharmacokinetics of BIBR 1048 MS~     and BIBR 953 ZW in man.~   "
99336|NCT02267018|"~     Preterm babies have immature lungs and frequent pauses in their breathing which often~     necessitates breathing support. Nasal Continuous Positive Airway Pressure (nCPAP) is one of~     the most commonly used tools, but does not always provide enough support. A new option is~     non-invasive high frequency ventilation (NIHFV), which gently shakes the lungs to help with~     gas exchange and may decrease a baby's work of breathing. The investigators plan to study~     very low birth weight preterm babies who are generally well but require some support with~     their breathing. By inserting a special feeding tube with sensors into the stomach, the~     investigators can measure the electrical activity of the diaphragm (EAdi), which is an~     important muscle for breathing. By analyzing EAdi in babies receiving either nCPAP or NIHFV,~     the investigators will be able to measure and compare how each method of support affects a~     baby's breathing. This important study will help us determine the most appropriate breathing~     support for preterm babies.~   "
99337|NCT02267005|"~     This project will bring together a multidisciplinary team of pediatric rheumatologists,~     neurologists, metabolic geneticists and exercise physiologists to determine the effect of~     creatine (CR) supplementation on muscle function and muscle metabolism in children with~     Dermatomyositis (DM). The investigators propose using well-established exercise testing~     techniques as well as new, powerful exercise imaging protocols in order to better delineate~     the effects of CR on muscle pathophysiology in a non-invasive way. Evidence from this study~     will provide information regarding the effect of creatine supplementation on muscle function~     in DM. Improvements in muscle function and fatigue through CR use may also contribute to an~     improvement in quality of life and have significant clinical implications for the treatment~     of children with DM.~   "
99338|NCT02266992|"~     Influenza ('flu) can cause severe infections, especially in people with weakened immune~     systems such as those with HIV. For this reason, yearly vaccination is recommended with the~     standard 'inactivated' influenza vaccine to try and prevent infections in these populations.~     It is also recommended in all health care workers, to help prevent the spread of influenza~     within healthcare settings. However, having HIV infection may mean vaccines work less well in~     some people and the investigators do not completely understand why. An alternative to the~     standard 'inactivated' annual influenza vaccine is the 'live attenuated influenza vaccine'~     (LAIV), which means it consists of weakened versions of the influenza virus.~      Unlike the standard vaccine, which is given by injection, LAIV is a spray that is given into~     each nostril. It is now given to children in the UK in preference to the standard vaccine as~     it results in greater protection from influenza. In some other countries, like the USA,~     adults are also given LAIV, where it seems to work just as well as the standard vaccine. A~     few studies in the past have shown that LAIV is safe and effective in HIVinfected children~     and adults. The investigators want to give LAIV to HIVinfected and HIV negative individuals,~     to try to find out new information about how HIV infection may change the way in which people~     respond to vaccines. The investigators will do this by comparing both the early genetic~     response to the vaccines and later responses from cells specifically targeted to fight~     influenza ('Tcells'), in these groups. In the long term, the investigators hope that this~     will lead to designing new ways of improving the response to vaccines in HIVinfected people.~     As LAIV is given into each nostril, rather than an injection, the investigators also want to~     see if LAIV results in Tcells in the lung that are specifically targeted to fight influenza~   "
99339|NCT02266979|"~     As the resolution of the Brazilian Federal Council of Nursing (COFEN) sizing the framework of~     nursing professionals is essential to ensure the safety and quality of patient care. To~     achieve such goals actions are needed to evaluate the variety of tasks and performance~     specific to each area in nursing profession. The National Agency for Health Surveillance~     (ANVISA), through Board Resolution (RDC-154) determines that the nurse to patient ratio is 1~     to 30 in hemodialysis and 1 to 50 on peritoneal dialysis, however these targets are not based~     on any evidence, and same apply to other Latin-American countries. Objective: To determine~     the appropriate nurse: patient ratio for peritoneal dialysis unit. Method: This research will~     be developed in two phases. The first with an observational design with descriptive and~     qualitative approach. There will be a focus group with experts in the field, to defined the~     activities and responsibilities of the peritoneal dialysis nurse, and produce a tool with a~     list of activities. A time-orientated score will be created. In the second stage a~     cross-sectional quantitative approach will be used. To apply the instrument from by direct~     observation of activities performed by nurses during their workday. With the instrument~     activities will be timed and the overall time of each nursing activity will be determined by~     multiplying the time spent by the total number of patients. It is expected tat this strategy~     will increase time on treatment and/or decrease dropout rates, by developing an easy test/~     formula application to determine the correct ratio according to the peritoneal dialysis~     program. This tool will provide better outcomes for patients as well as allow for growth of~     peritoneal dialysis programs with qualified assistance and patient safety.~   "
99340|NCT02266966|"~     The aim of this functional Magnetic Resonance Imaging (MRI) study is to assess the effect of~     single dose of F2695 at 75mg on modulation of the cerebral motor network.~   "
99341|NCT02266953|"~     The purpose of this study is to promote optimal nutrition for the child based on the public~     health nurse's family-focused conversations at the child health centre. An image based~     communication tool is used in an intervention in order to promote dialogue and active~     participation by the parents about themes concerning food and feeding practices.~   "
99342|NCT02266940|"~     This is an open label, randomised, 3 treatment, 3 period crossover study. This study is~     designed to assess the relative bioavailability of DS 1971a from a tablet formulation and a~     reconstituted oral suspension and the effect of a high fat meal on the relative~     bioavailability of DS 1971a from the tablet formulation.~   "
99343|NCT02266927|"~     To compare the systemic exposure of a single dose of 400 µg of OPTINOSE FLUTICASONE with 440~     µg of Flovent® HFA (fluticasone propionate) Inhalation Aerosol in asthmatic subjects.~   "
99344|NCT02266914|"~     Magnetic Resonance Elastography (MRE) for cardiac transplant patients.~   "
99345|NCT02266901|"~     Patients presenting intra-abdominal abcesses following bariatric surgery complicated by~     fistulae are classically treated by external drainage and endoprosthesis or surgical redo.~     Morbidity and mortality being increased in case of necrotic collections, an endoscopic~     debridement treatment might be proposed in certain cases. This present study aim to review~     the evolution of the patients treated by this method from 2007 to 2011 in the investigators~     institution.~   "
99346|NCT02266888|"~     In this study, doctors are trying to see if a study drug called rituximab (Rituxan®) will~     lower the number of B cells in the body. Doctors are also trying to see if decreasing B cells~     with rituximab (Rituxan®) can prevent injury to the transplanted lung. This treatment has~     been studied in other types of solid organ transplants.~   "
99347|NCT02266875|"~     A comparison of albuterol treatments using hypertonic saline (3%) versus standard saline~     (0.9%) in patients with admitted patients COPD in regard to Modified Borg Dyspnea scale~     scores after 4 treatments within 24 hours.~   "
99349|NCT02266849|"~     Clinical experience show limited effect of the drug Loperamide used to decrease output in~     stoma patients. Therefore the investigators see the need for a randomized blinded clinical~     trial to determine the effect of Loperamide opposite Placebo.~      Loperamide will be evaluated in relation to the following parameters~        -  Change in ileostomy output in g/day in relation to oral intake~        -  Quantification of the change in intestinal transit time using a radiopaque marker~        -  The patient´s own assessment on which period they received Loperamide or Placebo~   "
99350|NCT02266836|"~     The purpose of this study is to examine the efficacy of MyndMove therapy in the early~     sub-acute, late sub-acute and chronic post-stroke patients. Other objectives include~     assessing the required doses of electrical current amplitudes, the usability of the device,~     and examining the overall safety.~   "
99351|NCT02266823|"~     The purpose of this study is to pilot test an mHealth technology-supported behavioral~     intervention designed to engage patients with diabetes and concurrent chronic kidney disease~     (CKD) in multiple behaviors which aim to reduce CKD progression. Participants will be~     randomized to the 6-month lifestyle intervention or to a wait-list control. The lifestyle~     intervention will be modeled after that used in the Diabetes Prevention Program (DPP) and the~     counseling intervention will be based on SCT, which will be paired with mobile~     technology-based dietary and physical activity monitoring. The wait-list control will receive~     6 months of standard medical care followed by a delayed, but less intensive, 6-month~     intervention.~   "
99352|NCT02266810|"~     The objective of the PROGRESS Study is to assess the safety and efficacy of the Propel Mini~     and Propel Nova steroid-eluting Sinus Implants when placed in the frontal sinus opening~     following frontal sinus surgery in patients with chronic sinusitis.~   "
99353|NCT02266797|"~     This is a randomized, double-blind, placebo-controlled study to examine the effect of local~     intravenous steroids following anterior cervical spine surgery on the development of~     dysphagia in patients.~   "
99354|NCT02266784|"~     The overall goal of the study is to evaluate how motivation and readiness for change are~     influenced in the context of a smoking cessation attempt. A total of 60 adult (i.e. age~     18-55) smokers (N=40 with ADHD; N=20 without ADHD) who are interested in quitting will be~     enrolled into a 3-arm trial allocated as follows. Twenty of the ADHD smokers and the 20~     non-ADHD smokers will be assigned to a traditional 8-week contingency management intervention~     in which monetary payments will be made contingent upon biologically verified evidence of~     smoking abstinence. The 20 additional ADHD smokers will be assigned to a treatment-as-usual~     condition (nicotine replacement; supportive counseling). During the treatment phase, subjects~     will be required to answer questions 4x/week in their daily lives via an EMA (Ecological~     Momentary Assessment).~      Specific Aim 1: To assess motivation to quit smoking and readiness for change prior to a quit~     attempt in treatment seeking ADHD and non-ADHD smokers. Hypothesis 1a: The investigators~     hypothesize that prior to a quit attempt, smokers with ADHD will exhibit significantly lower~     levels of intrinsic motivation to quit, and equal or higher levels of extrinsic motivation to~     quit compared to smokers without ADHD. Hypothesis 1b: The investigators hypothesize that~     smokers with ADHD will exhibit relatively less readiness for change than smokers without~     ADHD.~      Specific Aim 2: To assess how baseline levels of motivation to quit and readiness for change~     are influenced during a quit attempt as a function of both ADHD status and treatment~     modality. Hypothesis 2a. The investigators hypothesize that the CM intervention will result~     in relatively greater change in extrinsic motivation to quit versus intrinsic motivation to~     quit, and that this effect will be more pronounced among ADHD smokers. Hypothesis 2b: The~     investigators hypothesize that overall motivation to quit (intrinsic and extrinsic) and~     readiness for change will be significantly influenced by the CM intervention versus treatment~     as usual among ADHD smokers.~      Exploratory Aim 1: To assess the relative efficacy of a CM intervention versus treatment as~     usual in smokers with ADHD. The investigators hypothesize that CM will be more effective for~     promoting short-term (4-8 weeks) smoking abstinence, as well as for promoting longer-term~     (3-6 months) smoking cessation.~      Exploratory Aim 2: To assess the associations among smoking withdrawal/craving, affect, ADHD~     symptoms, and motivation to quit/readiness for change. The investigators hypothesize that~     higher levels of motivation and readiness for change will be associated with lower levels of~     self-reported withdrawal, craving, and negative affect.~   "
99355|NCT02266771|"~     The objective to this study is to determine the effectiveness of V.A.C.Veraflo negative~     pressure wound therapy with instillation, when compared to historical controls of V.A.C~     Therapy without instillation in the management of wounds.~   "
99356|NCT02266758|"~     This project randomizes two different screening strategies for diabetes in pregnancy, among a~     study population of over 17,500 pregnant women and their babies (over 35,000 total) in a~     large diverse health maintenance organization (HMO), to determine how diagnosis and treatment~     based on these two strategies in routine clinical care affects complications for the baby and~     the mother.~   "
99357|NCT02266745|"~     This is a Phase I, open-label, multi-center, non-randomized, dose-escalation study to be~     conducted in two parts: the Dose Escalation Phase and the Dose Confirmation Phase. The Dose~     Escalation Phase will determine the Maximum Tolerated Dose (MTD) and recommended Phase 2~     dose(s) (RP2D) of PT-112 Injection and evaluate its safety and tolerability, PK~     (pharmacokinetic) and preliminary clinical effects. The Dose Confirmation Phase will be a~     cohort expansion at or below the MTD of PT-112 Injection. Subjects who tolerate the drug and~     who do not experience progressive disease may continue to receive PT-112 Injection at the~     discretion of the Principal Investigator for up to 6 cycles. For subjects who tolerate PT-112~     Injection and who experience an objective response or stable disease through 6 cycles, the~     Sponsor will continue to provide PT-112 Injection under a separate mechanism, e.g., an~     extension protocol.~   "
99358|NCT02266732|"~     The traditional model of localizing a nerve for blockade is using a peripheral nerve~     stimulator, PNS. Recent advances in UltraSound technology has allowed UltraSound to guide~     nerve blockade. However despite excellent visualization nerve block success has not~     significantly improved. I aim to show that this is because the PNS stimulation of a nerve is~     more than a proximity response as thought but a correct fascial plane response and hence the~     high success rate of this blind approach.~   "
99359|NCT02266719|"~     This is an investigator sponsored Investigational Device Exemption (IDE) aimed to assess the~     use of the Custom Made Device (CMD) to repair juxtarenal aneurysms, suprarenal and type IV~     thoracoabdominal aneurysms in standard risk patients having appropriate anatomy. This study~     is a prospective, single-center, non-randomized, single-arm study.~   "
99360|NCT02266706|"~     The purpose of this study is to assess the pharmacokinetics, safety, and tolerability of a~     single intravenous dose of ceftolozane/tazobactam in pediatric participants.~      Ceftolozane/tazobactam is a novel antibacterial consisting of ceftolozane, a unique~     antipseudomonal cephalosporin, with tazobactam, a well-established β-lactamase inhibitor.~      This is the first study investigating the use of ceftolozane/tazobactam in pediatric~     participants.~   "
99361|NCT02266693|"~     This 8-week, pilot randomized, controlled trial to evaluate the benefits of transdiagnostic~     Internet-based CBT (iCBT) in young adults with MDD, SAD, PD or GAD. The investigators~     hypothesize that patients who receive iCBT will show significant improvement in anxiety~     symptoms and functioning, compared to a wait-list group. This pilot randomized controlled~     study will assess the efficacy of transdiagnostic iCBT in 60 young adults.~   "
99377|NCT02266485|"~     Investigation of pharmacodynamics (inhibition of oxidosqualene cyclase, MES as marker),~     effect on routine lipid profile parameters, safety and preliminary pharmacokinetics~   "
99362|NCT02266680|"~     The goal of this study is to determine the safety and effectiveness of Breathing Focused Yoga~     (BFY) in improving symptoms of social anxiety disorder (SAD). Patients with SAD will be~     randomized to 8 weeks of yoga or 8 weeks of wait-list. Symptom severity and quality of life~     will be compared between the two groups before and after the 8 weeks.~   "
99363|NCT02266667|"~     The purpose of this study is to evaluate the performance of the device NEMOST on~     maintaining of the correction of the scoliosis with growth preservation and avoiding~     iterative surgeries.~      Objective of this study is to evaluate the performance of the growing device NEMOST~     associated to physiotherapy at 12 months postoperatively in patients treated for progressive~     scoliosis and to evaluate its safety.~   "
99364|NCT02266654|"~     The goal is to evaluate the best way for paramedics and hospitals to work together to treat~     septic patients as quickly as possible.~      The investigators think that the best thing to do for septic patients is to identify and~     treat them as early as possible. This research will test this. The investigators think that~     if paramedics identify septic patients and begin treatment with fluids in the ambulance, then~     the patient will do better in the long run. The paramedic will also tell the hospital that a~     septic patient will be there soon. The caregivers can prepare and be ready to provide care as~     soon as the patient arrives. With this research, the investigators would like to see if these~     steps help patient outcomes.~   "
99365|NCT02266641|"~     Parental one-carbon nutrient intake (folic acid and choline) and the genetic polymorphisms of~     one-carbon metabolic enzyme were interact with regulating embryonic one-carbon metabolic~     environment, affect fetal DNA and RNA biosynthesis and methyl modification of the genome~     molecule, to promote the individual nutrient growth factor of growth and development.~     Inadequate maternal one-carbon nutrient intake combined with genetic polymorphisms of~     one-carbon enzymatic mutation, causing one-carbon malnutrition, change fetal methyl metabolic~     nutrition environment. It not only leads to fetal growth mutation - such as folate and~     choline deficiency, increasing the risk of fetal neural tube defect but also induce abnormal~     modifying of fetuses's post-genomic methylation markers, may alter imprinted genes function~     of progenitors, recompile threshold sensitivity or domain in regulation of metabolic~     reactions of offspring, resulting in long-lasting effect, increasing the risk of chronic~     diseases of offspring such as cancer. According to the National Nutrition Survey results show~     that a considerable proportion of the Taiwanese people had poor one-carbon nutritional~     status. 48% of women intake 66% below the recommended intake reference value of folate.~     Whether inadequate parental one-carbon nutrients intake combined with genetic polymorphisms~     of one-carbon enzymatic mutation will cause one-carbon malnutrition of fetus, affecting fetal~     growth and modifying the risk of cancer development relationship of offspring. It is due to~     the lack of local ethnic data and empirical scientific reference at home and abroad, so it~     can not plan an effective maternal and children nutrient education and prevention strategies~     about methyl nutrition for early cancer prevention for Taiwanese. Therefore, indigenous~     people is the intended population of study in this project, screening of healthy pregnant~     women with high risk factor for cancer and obese pregnant women, and detection of one-carbon~     nutrient intake and biochemical assessment of the nutritional status of the study group.~     Supplying nutrition education intervention or multivitamin supplement to improve the poor~     nutritional status of persons. Using related DNA methylation imprint marker about offspring~     growth and modifying development of cancer as assessment, this project explores the~     appropriate one-carbon nutrient intake in parents and children and the assessments in~     regulation of growth and reducing the cancer-related risk.~   "
99366|NCT02266628|"~     The purpose of this study is to evaluate the safety and immunogenicity of the RSV- F Vaccine~     in elderly subjects, as well as rate the incidence of medically- attended RSV disease in~     vaccine and placebo recipients.~   "
99367|NCT02266615|"~     Collection of coded biomaterial and clinical data with patients consent for future research.~   "
99368|NCT02266602|"~     Single arm study to assess the effectiveness of single dose intraoperative radiation therapy~     in patient with in situ and early stage breast cancer.~   "
99369|NCT02266589|"~     The purpose of this study is to find out whether stress doses of hydrocortisone attenuate~     coagulation dysfunction in patients with septic shock. And discuss the probable mechanism by~     which little doses of hydrocortisone influence coagulation system in sepsis.~   "
99370|NCT02266576|"~     The goal of the proposed research is to identify effective patient-centered strategies to~     prevent diabetes in high-risk populations in real world settings. The investigators will~     accomplish this by conducting a randomized controlled trial comparing an enhanced Diabetes~     Prevention Program addressing psychosocial stressors to a standard version in a high-risk~     population of urban American Indian and Alaskan Native peoples within a primary care setting.~   "
99371|NCT02266563|"~     The potential long-term effects of Traumatic Brain Injury (TBI) are poorly understood.~     Repeated concussions have been associated with an elevated incidence of Alzheimer's disease~     (AD) along with a reduced age of onset. As repetitive TBI has been studied, a syndrome has~     now been identified: chronic traumatic encephalopathy (CTE). There are growing concerns about~     the long-term neurologic consequences of head impact exposure from routine participation in~     contact sports (e.g., boxing, football). Brain autopsies of athletes with confirmed CTE have~     demonstrated tau-immunoreactive neurofibrillary tangles and neuropil threads (known as~     tauopathy). The relationship between exposure to repetitive head impact and the subsequent~     development of chronic neurodegenerative disease has not been established. Further, as the~     diagnosis of CTE (defined by the presence of tauopathy) is presently made after death at~     autopsy, clinical tools and biomarkers for detecting it remain to be defined.~      With the advent of FDA-approved PET amyloid imaging, clinicians and researchers are now able~     to estimate plaque density in the brains of living patients. However, there are critical~     limitations to amyloid imaging. Current evidence suggests that markers of the presence and~     severity of tauopathy may be able to address these limitations. The study will utilize both~     [18F] Florbetapir and [18F]-T807 PET imaging to investigate amyloid and tau accumulation in~     subjects with a history of concussions. In order to determine whether problems with cognition~     and memory are seen within the populations defined for the study, the researchers will~     administer a core battery of neurocognitive testing. This battery will assess cognitive~     abilities commonly affected by TBI, including processing speed, reaction time, new~     problem-solving, executive functions, attention and concentration, and learning and memory.~     These tests, in conjunction with the imaging, will be able to determine whether regional~     brain activity is associated with specific cognitive problems. The researchers will obtain~     PET and neurocognitive data in 3 cohorts: subjects with a history of TBIs, subjects with mild~     cognitive impairment (MCI) and no TBI history, and healthy controls.~      The investigators aim to determine whether individuals with TBI are on the same trajectory of~     neurodegenerative disease seen in AD or in CTE. Because of the overlap in clinical/cognitive~     and some behavioral symptoms in AD and CTE, an additional biomarker tool is needed to prevent~     misdiagnosis. Accurate diagnosis is crucial in order to provide patients with appropriate~     treatment.~   "
99372|NCT02266550|"~     The aims of this phase I study are to define the metabolism, excretion and pharmacokinetics~     of [14C]-BIIL 284 BS after administration of a single oral dose of 25 mg [14C]-BIIL 284 BS in~     6 healthy volunteers. Tolerability was also assessed.~   "
99373|NCT02266537|"~     The study was aimed to evaluate the pharmacological effect of different α-antagonists on~     phenylephrine induced pupil size in healthy male volunteers as pharmacological basis for~     Intraoperative floppy iris syndrome (IFIS)~   "
99374|NCT02266524|"~     To investigate pharmacokinetics, safety, and tolerability of tamsulosin hydrochloride in~     children with voiding disorders~   "
99375|NCT02266511|"~     The objective of this study is to determine the bioequivalence of two batches of Flomax® 0.4~     mg capsules in healthy male subjects. One is a commercial scale batch produced at the Nishine~     facility, and the other is a batch, of equal size, produced at the Norman II facility~   "
99376|NCT02266498|"~     To assess the effect of a breakfast (40 g fat) on single dose pharmacokinetics of a 2.5 mg~     BIBB 515 dose in capsules as well as the tolerability of BIBB 515 BS capsules~   "
99378|NCT02266472|"~     The purpose of this trial is to investigate bioequivalence of a newly developed fixed dose~     combination (FDC) tablet containing empagliflozin and metformin extended release compared to~     the free combination of empagliflozin and metformin extended release under fed conditions.~   "
99379|NCT02266459|"~     This is a prospective, open, multicenter study that will enroll patients admitted to and~     hospitalized at the Stroke Unit due to diagnosed stroke and healthy volunteers.~      The main purpose of the study is to evaluate the ability of the Microwave Technology to~     deliver adequate measurement data.~   "
99380|NCT02266446|"~     The purpose of the study is to develop a personalized, user-friendly computerized treatment~     for anxiety disorders linked to primary care. The computerized treatment is a type of~     Cognitive Bias Modification, which targets attention and interpretation biases known to~     maintain anxiety disorders.~   "
99381|NCT02266433|"~     The primary objective of this study is to compare local corticosteroid hand and elbow~     injections to placebo or ketorolac to determine if there is an equal or better reduction of~     symptoms for common orthopaedic upper extremity disorders including: De Quervain's~     tenosynovitis, trigger fingers, and tennis elbow (lateral epicondylitis). The investigators~     will enroll 780 subjects, divided equally into three arms for each disease process, and~     compare the efficacy of Ketorolac injections to Dexamethasone injections by measuring~     patient's functional status scores and pain scores at 0 weeks, 4 weeks, 8 weeks, 12 weeks,~     and 6 month followup periods, prospectively over time.~   "
99382|NCT02266420|"~     This is a prospective, non-randomized and multicenter study designed to compare biological~     features between pN0 triple negative breast cancer (TNBC) with size ≤ 10 mm (pT1a/b) versus~     pT1c T2 ≤ 30 mm.~      All consecutive patients will be recruited by each investigator after completion of surgery.~     No modification of standard management according to each investigator center will be done.~     All patients will then be followed each year during 5 years in order to collect the following~     events: local and loco regional recurrence, metastatasis, second cancer, death or not and the~     cause.~      At initial visit, a 10 mL blood sample will be collected (= study intervention) and~     immediately processed for serum storage; all serum samples will be stored at -80°C and may be~     used for the purpose of further scientific research.~      A representative formalin-fixed paraffin-embedded tumor block of all 200 samples will be~     addressed at the Institut Claudius Regaud for central collection which will consist of one~     haematoxylin-eosin stained slide for central histological review, up to 15 unstained slides~     for DNA extraction (after microdissection), and construction of a tissue micro-array (TMA).~      Extracted DNA from 100 samples (50 in each group) will then be transferred to Institut Paoli~     Calmettes, Marseille; extracted DNA will be subjected to array-CGH analysis in order to~     detect gene copy number alterations such as gains/amplifications/deletions, and to next~     generation sequencing (NGS; MiSeq, Illumina) using a panel of ~400 genes for mutation~     detection.~   "
99383|NCT02266407|"~     To assess the surgical and economic effectiveness of the Aquamantys System in managing intra-~     and post-operative blood loss, and reducing transfusion needs in patients undergoing both~     aseptic and septic revision total knee arthroplasty.~   "
99384|NCT02266394|"~     Current treatments for ARAS based on restoring blood flow alone have been unsuccessful at~     recovering kidney function. For this reason we are studying a stem cell product called~     mesenchymal stem cells or MSC. Mesenchymal stem cells (MSC) are grown from a person's own~     fat tissue (obtained as a fat biopsy) and infused back into the patient's own kidney.~      This study is also being done to determine if the MSC infusion prior to percutaneous~     transluminal renal angioplasty with stenting (PTRA) further enhances changes in single kidney~     blood flow and restoration of kidney function, as well as to assess the relationship between~     MSC dose and measures of kidney function.~   "
99385|NCT02266381|"~     Purpose:~      The aim of this present study is to compare the result of fluoroscopy, ultrasonography (US)~     and US combined with fluoroscopy in the guidance of minimally invasive percutaneous~     nephrolithotomy (MPCNL).~      Methods:~      The investigators will enroll 450 patients who are candidates for MPCNL in our study. By~     simple random sampling technique, patients will be assigned to three 150-patient groups~     (group 1, US-guided MPCNL, group 2, fluoroscopy-guided MPCNL and group 3, US combined with~     fluoroscopy-guided MPCNL). In addition to approaches in guidance of MPCNL, the rest of the~     procedure is the same in all three groups.The end point of the study is the comparison of~     outcome of procedure including stone free rate, transfusion rate, operation time, access~     time, length of stay and complications.~   "
99386|NCT02266368|"~     This study will be conducted to compare the efficacy of antimicrobial coated ureteral stent~     with non-coated stents in prevention of UTI in patients with ureteral stents~   "
99387|NCT02266355|"~     Pilot study to evaluate the activity of omalizumab in the prevention of recurrent oxaliplatin~     hypersensitivity reaction (HSR) in oxaliplatin-sensitive patients. The study will also~     evaluate the safety of omalizumab (Xolair) when administered in this setting.~   "
99388|NCT02266342|"~     This is a French Registry mandated by the French National Health Authority assessing~     long-term (5-years) safety of the GORE® TAG® Thoracic Endoprosthesis treating diseases of the~     thoracic aorta.~   "
99389|NCT02266329|"~     The purpose of this study is to determine if prazosin is more effective than placebo in~     decreasing frequency, severity, disability, and other negative effects of headaches related~     to mild traumatic brain injury in Service Members and Veterans.~   "
99397|NCT02266225|"~     The goal of this study is to evaluate how to implement an evidence-based lifestyle-integrated~     strength and balance exercise (LiFE) intervention in primary care to promote increased~     physical activity (PA) and improvements in function and quality of life in older adults 75~     years or older. This study will evaluate the public health impact of the LiFE intervention~     using the RE-AIM model: reach (recruitment), effectiveness (PA levels), adoption (physician~     acceptance), implementation (fidelity), and maintenance (retention, adherence). If the~     intervention appears feasible, we will use the resultant information to design a larger~     pragmatic trial.~   "
99424|NCT02265874|"~     The purpose of this study is to determine if nicotine treatment is beneficial for the~     treatment of sarcoidosis. Sarcoidosis is a disease of unknown cause that leads to~     inflammation. This disease affects your body's organs.~   "
99439|NCT02265666|"~     The objective of the present study is to investigate the relative bioavailability of BIIL 284~     BS Tablet FF in comparison to the tablet C at a dose of 5 mg after a standard breakfast in~     healthy male volunteers~   "
99390|NCT02266316|"~     The World Health Organisation defines chronic obstructive pulmonary disease (COPD) as 'not~     one single disease but an umbrella term used to describe chronic lung diseases that cause~     limitations in lung airflow' covering emphysema and chronic bronchitis; and estimates (2004)~     that worldwide there are currently 64 million sufferers with 3 to 4 million in the UK.~      COPD results from damaged airways in the lungs, causing them to become narrower and making it~     harder for air to get in and out of the lungs. It is diagnosed by measuring the amount of air~     that can be expelled in the first second of breathing out (FEV1) in litres per second.~      COPD is a progressive disease and the condition can have a serious impact on the quality of~     life of sufferers. Going out in very cold weather can cause an immediate drop in FEV1, and~     increased breathlessness.~      This is a randomised crossover controlled trial of participants with COPD. It compares the~     effectiveness of an air-warming face mask which covers the mouth compared with no face~     covering, in increasing participants exercise capacity and quality of life in cold weather.~     The mask warms air at the mouth by drawing on air warmed beneath the participants clothing,~     through a 20cm long hollow plastic tube and a one-way inspiratory valve into the mask. Air is~     expired through the nose.~      24 participants with moderate or severe COPD, will undertake 3 exercise tests on 3 separate~     days. Two tests will be in an environmentally controlled chamber performed at 5°C with~     participants wearing either the mask or no face covering. The third test will be performed at~     ambient temperature outside the chamber.~      The order will be determined by random allocation. Participants will undergo the Treadmill 6~     Minute Walk Test; various measurements will be taken, all of which will be non-invasive.~   "
99391|NCT02266303|"~     The increasing prevalence of diabetes is associated with increased insulin use. In developing~     countries it is frequently necessary to use insulin, with the needle and syringe method of~     administration being the cheapest approach. Competence of health care professionals is~     required to safely initiate insulin. The investigators will evaluate whether using a~     checklist during insulin initiation with a needle and syringe, can improve the safety and~     efficacy of its use.~   "
99392|NCT02266290|"~     The Objective is to examine the immediate and prolonged effects (seven days) of Kinesio® Tape~     (KT) on balance in subjects with chronic ankle instability using Computerized dynamic~     posturography (CDP). Design. A 7 days follow-up, single-blind randomized controlled trial.~     Setting. University community. Participants. A sample of 30 subjects aged 18 to 28 with CAI~     and subjective perception of ankle instability (FAI) was enrolled in this study.~     Interventions. Participants will be randomly divided into two groups: an experimental group~     in which was applied KT, and a control group in which was applied a placebo tape.Objective.~     To examine the immediate and prolonged effects (seven days) of Kinesio® Tape (KT) on balance~     in subjects with chronic ankle instability using Computerized dynamic posturography (CDP).~     Design. A 7 days follow-up, single-blind randomized controlled trial. Setting. University~     community. Participants. A sample of 30 subjects aged 18 to 28 with CAI and subjective~     perception of ankle instability (FAI) was enrolled in this study. Interventions. Participants~     were randomly divided into two groups: an experimental group in which was applied KT, and a~     control group in which was applied a placebo tape. Main Outcome Measure(s). The CDP device~     employed in this study was Smart Equitest® version 8.2. CDP analysis was conducted using the~     Sensory organization test (SOT). The composite SOT score (COMP) and the composite SOT~     strategy (STR), the partial score for SOT condition 2 (SOT 2) and its strategy (STR 2) were~     considered as outcomes measures.~   "
99393|NCT02266277|"~     The goal of this research study is to improve rates of appropriate influenza and pneumococcal~     vaccination among adults who receive care at a large multi-specialty group practice in~     central Massachusetts.~      The investigators plan to conduct a non-blinded randomized controlled trial during flu season~     2014-2015 (Cycle 1). A total of 20,000 e-portal users and 10,000 non e-portal users who are~     identified in the Reliant Medical Group (RMG) Electronic Health Record (EHR) as not being up~     to date on their influenza vaccines will be randomized.~      E-portal users will be randomized to receive:~        -  Arm 1: E-portal message with Interactive Voice Recognition (IVR) call~        -  Arm 2: E-portal message with no IVR call~        -  Arm 3: No e-portal message with IVR call OR~        -  Arm 4: No e-portal message with no IVR call (Control, e-portal users)~      Non e-portal users will be randomized to receive either:~        -  Arm 5: IVR call OR~        -  Arm 6: no IVR call (Control, non e-portal users)~   "
99394|NCT02266264|"~     The purpose of this study is to compare hyperglycemia and other effects, include 28-day~     mortality and time to reversal of shock between 100 milligrams and 200 milligrams of~     hydrocortisone as initial dosage in patients with septic shock.~   "
99395|NCT02266251|"~     Disease of the aortic heart valve is both common and progressively disabling, with no~     effective medical treatment. In November 2011, the United States Food and Drug Administration~     (U.S. FDA) approved a new, less invasive transcatheter alternative to surgical aortic valve~     replacement (AVR). This new technology has changed the treatment of patients with aortic~     valve disease. In doing so, it has created a pressing clinical need for shared decision~     making tools that will help patients understand the risks and benefits of each treatment~     alternative in the setting of their individual characteristics.~      The overarching goal of this study is to develop a new way to approach the treatment of~     medical illness, by focusing on the expected treatment outcomes for individual patients using~     information collected from large groups of patients. The corner-stone of this model is a~     public website that is designed to engage patients and clinicians in a personalized~     discussion of treatment alternatives. To achieve this goal for patients with aortic valve~     disease, we will use existing clinical data from the Society of Thoracic Surgeons (STS) and~     American College of Cardiology (ACC) national procedural registries that has been linked to~     Medicare claims for patient follow-up to 1) evaluate important health outcomes with surgical~     versus transcatheter AVR among patients who would be eligible for surgical AVR, and 2) create~     and evaluate personalized decision assistance tools for all patients considering AVR. This~     work will be accomplished in direct partnership with both patients and caregivers as well as~     a diverse group of stakeholders who will help ensure its usefulness and dissemination.~   "
99396|NCT02266238|"~     The purpose of this study is to compare the effect of DSA guided percutaneous balloon~     dilatation, ultrasound guided percutaneous balloon dilatation and surgical repair in the~     treatment of Stenosis of Arteria-Venous Fistula in Maintenance Hemodialysis Patients.~   "
116475|NCT02042937|"~     Can participants enhance gluteus maximus recruitment during a single-leg squat test following~     a neuromuscular training program?~   "
99398|NCT02266212|"~     Numbers of postoperative PCA(Patient-Controlled Analgesia) related side effects among~     current, past and non smokers are determined by comparing and analyzing frequency~     distributions. To determine whether smokers require more post operative opiate analgesics~     than others. Multivariate analysis will be performed to identify the major and the minor~     factors predicting the use of postoperative pain therapy. Our previous related study showed~     that the smoker male patients consumed more analgesics than those without smoking, but the~     female group showed the similar findings. However, the case number, especially the female~     cases, is underpowered. Investigators hope to increase the case number to have a better~     statistical and clinical significance.~   "
99399|NCT02266199|"~     The study includes operative as well as conservative patients using a questionnaire~     containing items of pain quality. After having completed the questionnaire, the patient is~     interviewed by an assistant. By this way the new questionnaire should be validated.~      In addition the patient´s personal experiences are included and conservative patients can be~     compared to operative patients.~   "
99400|NCT02266186|"~     The purpose of this project To study the efficacy of Internet-based guided self-help program~     of Cognitive Behaviour Therapy (ICBT) compared to traditional individual live CBT in a group~     of women with severe fear of childbirth (S-FOC). The treatment groups are compared with a~     control group receiving individual support at their antenatal clinics.~   "
99401|NCT02266173|"~     This Phase IV, prospective, multicenter, non-interventional study (regulatory post-marketing~     surveillance) will evaluate the safety of pertuzumab in approximately 3000 participants with~     metastatic or locally unresectable recurrent breast cancer who have never received~     chemotherapy or anti-human epidermal growth factor receptor 2 (HER2) therapy for their~     metastatic disease with HER2 positivity in Korea. Participants who are administered with~     pertuzumab according to medical opinions of the doctor in charge of surveillance will be~     registered for this study and treated with pertuzumab under the approval conditions of the~     product in Korea.~   "
99402|NCT02266160|"~     The investigators like to learn whether EMLA cream 5% helps tinnitus patients. so far it is~     known that lidocaine I.V do helps tinnitus but until now it is not clear if topical~     anaesthetics (e.g EMLA cream) helps tinnitus.~      The investigators are going to compare 4 days of treatment of EMLA 5% cream Versus (VS.)~     cetomacrogol cream (water- based lotion cream) in treating tinnitus patients.~   "
99403|NCT02266147|"~     To assess the safety and tolerability of escalating doses of SD-101 in combination with~     localized low-dose radiation therapy in adult subjects with untreated low-grade B-cell~     lymphoma.~   "
99404|NCT02266134|"~     Depression remains among the nation's top 10 chronic illnesses, costing over $80 billion~     annually; however, Measurement Based Care (MBC) is a relatively simple evidence-based~     intervention framework that has been shown to improve outcomes for depressed clients by~     identifying those who are not making progress and reducing the likelihood that clients will~     deteriorate in treatment. Despite the demonstrated effectiveness of MBC, the majority of~     community mental health counselors do not regularly assess target problem symptoms to guide~     their work. This study will test a standardized versus a tailored approach to implementing~     MBC that will include the integration of symptom monitoring capacities into the electronic~     health record system of one of the nation's largest not-for-profit providers of behavioral~     health services.~   "
99405|NCT02266121|"~     Noninvasive brain stimulations (NIBS) will be used in MS patients with cognitive impairments~     to enhance their cognitive aptitudes.~   "
99406|NCT02266108|"~     The proposed research aims to pilot a multi-strategy structural intervention combining~     community mobilization to promote gender equity alongside an economic intervention~     (microfinance and business training) in order to reduce gender-based violence and HIV risk~     among female sex workers (FSW) in Tijuana, Mexico. The program will be called ESTIMA:~     Economic and Social Empowerment To Increase Upwards Mobility Among Women. The evaluation~     will employ a randomized controlled design, recruiting FSW (n=120, 60 in each arm) who will~     be randomized to: 1) ESTIMA (gender equity/community mobilization program and economic~     intervention) or 2) a wait-list control group. For this preliminary work, at 12 months~     follow-up, we hypothesize that compared to control participants, intervention participants~     will have: 1) significantly greater economic security (e.g. decreased debt, increased income,~     decreased number of sex trades) and 2) significantly greater perceived collective power (i.e.~     collective efficacy) to address gendered power imbalances within social structures and the~     community. The long-term goal of this program, upon future refinement and large scale~     implementation, is to reduce HIV risk behaviors, STI/HIV, GBV, and ultimately, alleviate a~     multitude of health burdens among women. Furthermore, we expect that such work will highlight~     the need for HIV prevention initiatives in Mexico, and elsewhere, to more broadly consider~     women's 'life contexts' - addressing economic and social burdens in women's lives, to reduce~     the burden of poverty, gender, and HIV, as well as the intersection of these among women.~   "
99407|NCT02266095|"~     The oval-8 splint has been developed for many uses in finger pathology and trauma. It has~     not, however, been used to treat thumb carpometacarpal (CMC) joint arthritis. When treating~     thumb CMC joint osteoarthritis, splinting is a very widely used and supported treatment~     option for non-operative management. Many studies have been performed showing that thumb~     spica splinting in abduction with either a hand based or forearm based splint improves pain.~     This study aims to compare the effects of a novel splinting approach with oval-8 splints for~     the hyperextended thumb interphalangeal (IP) joint vs. standardized treatment with Tee Pee~     splinting (hand based thumb spica) or forearm thumb spica splinting on pain and function of~     patients with thumb CMC joint arthritis.~      This is a pilot study will address the following hypothesis: Splinting of the hyperextended~     thumb IP joint with oval-8 splints will lead to increased DASH scores and decreased pain on~     physical exam compared to splinting with thumb spica splints in patients with thumb CMC~     arthritis.~   "
99422|NCT02265900|"~     The therapeutic effects of exercise in Parkinson's disease (PD) are commonly reported,~     however the mechanisms are unknown. The purpose of this study is to investigate the potential~     mechanisms of exercise in the brain for the treatment of PD.~   "
99423|NCT02265887|"~     The study will recruit and follow up patients for six months patients newly diagnosed with~     pulmonary hypertension from twelve centers across four countries; South Africa, Mozambique,~     Cameroon, Nigeria. The main aim of the study is to describe the aetiology, natural history~     and management practices of pulmonary hypertension in Africa.~   "
99408|NCT02266082|"~     Women with early-stage breast cancer (BrCA) are surviving longer, but many experience~     symptoms after curative treatments. Approximately 50% of BrCA survivors experience persistent~     pain post-surgery. Identifying individuals at high risk for long-term symptoms is important~     for restoring function and enhancing quality of life. This pilot study will investigate~     psychological (depression, anxiety, catastrophizing) and biological (inflammatory markers,~     gut microbiome, pain sensitivity) correlates of persistent post-surgical pain in women~     participants with early-stage BrCA. The investigators will also investigate the type of~     surgery that participants had and whether it is related to persistent pain. The investigators~     plan explore these factors over time.~   "
99409|NCT02266069|"~     It is important to provide high quality palliative care to all patients with a non-curable~     and life-limiting condition. The Care Pathway for Primary Palliative Care (CPPPC) provides~     tools for health care professionals to help them delivering palliative care timely and~     accurately.This study investigates whether the implementation of the CPPPC really helps to~     improve patients' lifes.~   "
99410|NCT02266056|"~     Pneumoperitoneum, the use of carbon dioxide, presents some disadvantages, including a risk of~     hypercarbia and respiratory acidosis during surgery in the respiratory system, and of an~     increased mean arterial pressure and systemic vascular resistance due to sympathetic~     excitation in the cardiovascular system. 10~15 mmHg intra-abdominal pressure is required in~     order to achieve a pneumoperitoneum, and increased abdominal pressure following a~     pneumoperitoneum causes hemodynamic changes leading to a reduced cardiac function by~     increasing the left ventricular end systolic wall stress and the right and left ventricular~     filling pressure, while decreasing the stroke volume and cardiac index. The author compared~     the intra-abdominal pressure necessary to achieve a pneumoperitoneum under deep muscle~     relaxation and medium muscle relaxation in ten patients undergoing laparoscopic surgery for~     colorectal cancer as part of preliminary research. The results showed that deep muscle~     relaxation, compared to medium muscle relaxation, was able to lower the intra-abdominal~     pressure by an average of 5.6 mmHg (13.2 ± 0.8 vs 7.6 ± 1.1) and the inspiratory pressure by~     an average of 8. Above all, even after lowering the intra-abdominal pressure with deep muscle~     relaxation, the surgeon was able to maintain a view almost identical to the one afforded by~     medium muscle relaxation. However, up until now, no reports have clearly indicated the change~     in pneumoperitoneum pressure, the patient's hemodynamic change, post-operative recovery, and~     surgical prognosis depending on the depth of muscle relaxation.Against this background, this~     study aims to identify the degree to which intra-abdominal pressure in laparoscopic~     colorectal surgery can be reduced by deep muscle relaxation, and the corresponding advantages~     this method presents in terms of physiological changes such as hemodynamic and respiratory~     system changes. In addition, the study intends to examine the difference between deep muscle~     relaxation and medium muscle relaxation in terms of surgical prognosis, including their~     effects on post-operative pain and on the patient's recovery of intestinal mobility.~   "
99411|NCT02266043|"~     In a longitudinal cohort study, we want to assess the effect of the pre-epiglottic baton~     plate, the main treatment approach currently used in Germany for Pierre-Robin-Like phenotype,~     on upper airway obstruction and failure to thrive using objective criteria (mixed-obstructive~     apnea index assessed by polysomnography, standard deviation score for body weight) upon~     admission and 3 months after hospital discharge.~   "
99412|NCT02266030|"~     This is a prospective interventional study to assess the effect of cilostazol compared with~     aspirin in Korean T2DM patients with atherosclerosis.~   "
99413|NCT02266017|"~     Pain in cancer patients is estimated to be as high as 90% and results in physical and~     psychological disability. Behavioral interventions that increase patients' confidence in~     their ability to manage their pain have been shown to be beneficial. Behavioral interventions~     for cancer pain teach patients how their thoughts and feelings can influence their pain and~     specific strategies (e.g., relaxation) for decreasing cancer pain. However, despite~     guidelines recommending such interventions be used in the care of cancer patients with pain,~     they are not routinely used. A critical barrier to the use of behavioral interventions is~     that patients have difficulties attending appointments which are typically offered at the~     medical center during normal business hours. Mobile health (mHealth) technologies provide new~     opportunities to decrease such barriers. The investigators have developed a new mHealth~     approach that may increase the use of behavioral cancer pain interventions and ultimately~     lead to greater use of interventions that can decrease pain and disability.~      The investigators propose to test an approach that uses mHealth technologies to deliver a~     behavioral cancer pain intervention to patients in their home using a tablet computer (e.g.,~     iPad) and video-conferencing (e.g., Skype). The investigators will randomly assign 160 cancer~     patients with breast, lung, prostate, or colorectal cancer pain to receive either mHealth~     Pain Coping Skills Training system (mPCST) or to receive a traditional in-person pain coping~     skills training intervention protocol (PCST-trad) at the medical center. The investigators~     will test whether the mPCST is more accessible to patients than PCST-trad. The investigators~     expect that mPCST, compared to PCST-trad, will: a) be more feasible meaning that more~     patients will complete it in a timely manner; b) create less burden meaning it is easier for~     patients physically, emotionally, and financially to participate; c) increase engagement~     meaning that patients will practice skills more and have more understanding of the material;~     and d) be more overall acceptable to patients. the investigators also expect that patients~     who find this intervention more feasible, less burdensome, more engaging, and more acceptable~     will be more likely to experience decreased pain, physical disability, and psychological~     disability, and increased confidence in their ability to manage their pain.~      The investigators' goal is to use mHealth technologies to facilitate wide-spread use of~     behavioral cancer pain interventions. Increased use of mHealth behavioral cancer pain~     interventions will particularly benefit patients living far from medical centers (e.g.,~     rural), experiencing cancer-related physical challenges, and facing other practical barriers~     (e.g., transportation, work) to in-person interventions. These outcomes could lead to future~     work evidencing that mHealth behavioral interventions could be applied to other areas of~     quality of life in cancer patients (e.g., fatigue) and/or in other samples of patients with~     persistent pain (e.g., arthritis).~   "
99414|NCT02266004|"~     This study will evaluate the effcts of transcranial direct current stimulation (tDCS) in~     combination with locomotor training in patients with Parkinson's disease (PDD) and freezing~     of gait (FOG).~   "
99415|NCT02265991|"~     Pre- and postoperatively patients who underwent free fibula flap were examined regarding~     donor-site morbidity of the lower extremities.~   "
99416|NCT02265978|"~     This study evaluates the effectiveness of a mental health mobile app (CopeSmart) in promoting~     positive mental health through emotional self-awareness in adolescents. Participants will be~     recruited from second-level schools in Ireland. Schools will be randomly assigned to the~     intervention or control condition. Participants in the intervention condition will use~     CopeSmart for a four week period. Those in the control condition will not use any mental~     health app.~   "
99417|NCT02265965|"~     Randomized controlled clinical trial of IV nitroglycerin at cesarean delivery for second~     stage arrest of descent to prevent or uterine extension at the hysterectomy site.~   "
99418|NCT02265952|"~     This is an open-label, single-arm study to assess the reduction of low-density lipoprotein~     cholesterol (LDL-C) by REGN1500 in patients with homozygous familial hypercholesterolemia~     (HoFH).~   "
99419|NCT02265939|"~     Patients who require screening colonoscopy will receive an intraluminal spraying of NPO-13~     per contraction region of large bowel up to fifth times during the colonoscopy.~      The efficacy of NPO-13 will be evaluated based on the proportion of the splayed region with~     no contraction after NPO-13 dosage (primary outcome measure). The colonic spasm will be~     assessed by an independent committee using recorded video images.~      The safety of NPO-13 will be evaluated based on adverse events and adverse drug reactions~     (ADRs) observed between administration and seven days after administration.~   "
99420|NCT02265926|"~     The study aims to find out if usage of N95 type respirators affects respiratory parameters in~     pregnant women so as to provide guidance on N95 respirator usage in pregnant healthcare~     workers.~   "
99421|NCT02265913|"~     To compare safety and efficacy of Perrigo's antiviral drug product compared to an FDA~     approved antiviral drug product in the treatment of cold sores.~   "
137264|NCT01770548|"~     Neurophysiological, Molecular and Developmental Analysis of the glutamate synapse in Autism~   "
99425|NCT02265861|"~     This research is to investigate the response of vascular active factors, vascular endothelial~     growth factor (VEGF) and angiotensin-Ⅱ (AT-Ⅱ) to ovary stimulation during 24h in patients~     with polycystic ovary syndrome (PCOS).Controled prospective clinical study involved 60 women~     undergoing in vitro fertilization. Fifty-two patients with PCOS and 8 control cases were~     stimulated with human chorionic gonadotropin (HCG) during the early follicular phase of the~     menstrual cycle (4st to 7th days of the cycle).The blood was sampled before the injection (0~     hour) and at the 3, 6, 12, 18 and 24 hours points after the stimulation. VEGF, AT-Ⅱ were~     measured by radioimmunoassay.~   "
99426|NCT02265848|"~     Study designed to compare the conventional stimulation programming versus the high frequency~     stimulation programming of the spinal cord stimulator for subjects who already have a spinal~     cord stimulator.~   "
99427|NCT02265835|"~     Retrospective analysis of data concerning anastomotic airway complications after lung~     transplantation.~   "
99428|NCT02265822|"~     Melatonin has been proposed as alternative to midazolam as a premedication in procedures~     preceding anaesthesia induction. The objective of this prospective, randomized, double-blind~     study is to investigate the possible effect of melatonin premedication on the required~     infusion of propofol in comparison to midazolam, evaluating the efficacy of oral melatonin on~     sedation in children undergoing surgery.~      Preoperative anxiety and postoperative analgesia are also assessed in both groups.~   "
99429|NCT02265809|"~     Type 1 diabetes (T1D) is the most common severe autoimmune disease worldwide and is caused by~     the body's immune destruction of its own insulin producing pancreatic beta cells leading to~     insulin deficiency and development of elevated blood sugars. Currently, medical management of~     T1D focuses on intensive insulin replacement therapy to limit complications (retinopathy,~     nephropathy, neuropathy); nevertheless clinical outcomes remain suboptimal. There are~     intensive efforts to design novel immunotherapies that can arrest the autoimmune process and~     thereby preserve residual insulin production leading to fewer complications and better~     clinical outcomes.~      Genetics are in part the cause of T1D and the majority of genes contributing to T1D produce~     proteins involved in immune regulation (called tolerance). A key player in immune tolerance~     is a molecule called interleukin-2 (IL-2) which enhances the ability of cells called T~     regulatory (Treg) cells to suppress the destruction the insulin producing beta cells.~     Aldesleukin is a human recombinant IL-2 product produced by recombinant DNA technology using~     a genetically engineered E. coli strain expressing an analogue of the human IL-2 gene. There~     is substantial data to suggest that ultra-low doses (ULD) of IL-2 (aldesleukin) can arrest~     the autoimmune mediated destruction of pancreatic beta cells by the induction of functional~     Treg cells.~      The former study Adaptive study of IL-2 dose on regulatory T cells in type 1 diabetes~     (DILT1D) (NCT 01827735) was a single dose mechanistic study designed to establish the doses~     of IL-2 (aldesleukin) required to induce a minimal Treg increase (0.1 fold from baseline) or~     to induce a slightly larger Treg increase (0.2 fold from baseline) (maximal increase).~     Following on from the DILT1D study, the goal of the DILfrequency study is to use an adaptive~     design to determine the optimal dose and frequency of ULD IL-2 (aldesleukin) to maximize Treg~     function by frequently injecting ultra-low doses of IL-2 (aldesleukin). The responsiveness of~     each T1D participant to a particular frequency of IL-2 (aldesleukin) administration informs~     the frequency of dosing given to the next patient. This strategy focuses on improving the~     function of regulatory T cells that are exquisitely sensitive to IL-2 (aldesleukin).~   "
99430|NCT02265796|"~     This is a prospective, double-blind, placebo-controlled, randomized, single-center (North~     Florida- South Georgia VA Medical Center) study. The study objective is to determine if~     ranolazine improves angina symptoms at 4 months compared with placebo among stable coronary~     artery disease patients who have demonstrable myocardial ischemia, but who do not undergo~     revascularization~   "
99431|NCT02265783|"~     The purpose of this study is to validate that the device posts a Sensor-Off message within~     the time frame stated in the proposed claims.~   "
99432|NCT02265770|"~     The overall aim of this project is to improve the outcome of patients diagnosed with~     ependymoma by improving and harmonising the staging and the standard of care of this patient~     population and to improve the investigators understanding of the underlying biology thereby~     informing future treatment.~      The program will evaluate new strategies for diagnosis (centralized reviews of pathology and~     imaging) and new therapeutic strategies in order to develop treatment recommendations.~      Patients will be stratified into different treatment subgroups according to their age, the~     tumour location and the outcome of the initial surgery. Each subgroup will be studied in a~     specific randomised study to evaluate the proposed therapeutic strategies.~      Stratum 1:~      The aim of the stratum 1 is to evaluate the clinical impact of 16-week chemotherapy regimen~     with VEC-CDDP following surgical resection and conformal radiotherapy in terms of progression~     free survival in patients who are > 12 months and < 22 years at diagnosis, with completely~     removed intra cranial Ependymoma.~      Stratum 2:~      This stratum is designed as a phase II trial for patients who are > 12 months and < 22 years~     at diagnosis, with residual disease to investigate the possible activity of HD-MTX by giving~     to all patients the benefit of VEC chemotherapy whilst randomising half of patients to~     receive additional HD-MTX.~      Patients will receive conformal radiotherapy (cRT). For patients who remain with a residual~     inoperable disease after induction chemotherapy and cRT, an 8 Gy boost of radiotherapy to the~     residual tumour will be delivered immediately after the end of the cRT.~      Stratum 3 This stratum is designed as a phase II trial to evaluate the benefit of~     postoperative dose intense chemotherapy administered alone or in combination with valproate~     in children <12 months of age or those not eligible to receive radiotherapy .~   "
99433|NCT02265757|"~     This study will compare the effectiveness of different combinations of 5 types of behavioral~     interventions across patient-centered outcomes. It will also evaluate which outcomes (e.g.~     quality of life, cognition, function, mood) matter most to people at risk for dementia and~     their care partners. The results of this study have the potential to direct patients,~     families, and health care providers as to which combinations of behavioral interventions~     provide the greatest potential impact on which dementia prevention outcomes. Greater use of~     behavioral strategies that are targeted to the outcomes of most important to the patient will~     likely improve patient compliance and treatment adherence. This, in turn, can lessen the need~     for medication, health care, and long term care utilization.~   "
99434|NCT02265744|"~     Study evaluating the safety and efficacy of a novel biologic in the treatment of systemic~     lupus erythematosus in male and female adults. Patients who qualify will be randomized to~     either active BMS-931699 or placebo for initially, up to 24 weeks. Patients who complete the~     initial 24 weeks of treatment and who are responding to therapy will have the option to~     continue receiving BMS-931699 as part of a long-term extension (LTE). Disease activity and~     safety will be assessed over the course of the study through laboratory values, various~     rating scales accepted in systemic lupus erythematosus studies and patient self reporting.~   "
99435|NCT02265731|"~     This study is evaluating the safety, pharmacokinetic profile and efficacy of venetoclax under~     a once daily dosing schedule in Japanese participants with hematological malignancies.~   "
99436|NCT02265718|"~     The purpose of the study is to evaluate the difference in learning and performance measures~     associated with repeated use of an iPad video game (Akili Interactive's Project: EVO) in~     healthy elderly volunteers based on amyloid status.~   "
99437|NCT02265705|"~     The main purpose of this study is to evaluate the safety and effectiveness of the study drug~     known as baricitinib in participants with moderately to severely active rheumatoid arthritis~     who have had an inadequate response to methotrexate therapy.~   "
99438|NCT02265679|"~     Safety, tolerability and pharmacokinetics following single doses~   "
144058|NCT01681732|"~     A pilot study to test the feasibility of a personalized asthma care intervention.~   "
99440|NCT02265653|"~     The objective of the present study is to investigate the relative bioavailability of two BIIL~     284 BS tablets (tablet C and tablet C) in comparison to the WIF tablet at a dose of 75 mg~     following a standard breakfast in healthy male volunteers~   "
99441|NCT02265640|"~     The objective of the present study is to investigate the relative bioavailability of BIIL 284~     BS boli in comparison to the tablet C at a dose of 75 mg in fasted condition and after a~     standard breakfast in healthy male volunteers~   "
99442|NCT02265627|"~     To investigate the pharmacokinetics of a single dose of BIIL 284 BS in patients with hepatic~     impairment in comparison to healthy subjects~   "
99443|NCT02265614|"~     This project intends to use preimplantation genetic screening (PGS) with the microarray~     technique to determine the chromosome composition of fertilized eggs, so that only~     chromosomally normal embryos are transferred during IVF. The purpose is to increase the~     probability of pregnancy and childbirth among couples with a history of repeated unsuccessful~     IVF attempts.~   "
99444|NCT02265601|"~     This study is designed to help the investigators understand more about how people plan for~     their future medical needs, a process known as advance care planning.~      The study is under the direction of Michael J. Green, M.D., and Benjamin Levi, M.D.~     physicians at Penn State Hershey Medical Center.~      Participation in the project takes place during a single visit to the Medical Center campus.~     During this one-to-three hour visit, participants complete several questionnaires and use a~     computer program that produces a printed advance directive that can be shared with their~     physicians and loved ones. Participants will receive compensation toward travel expenses.~   "
99445|NCT02265588|"~     The presented study aims to reduce symptoms of depression and anxiety in adolescents with~     inflammatory bowel disease and increased symptoms of anxiety and depression by using the~     disease specific CBT program (PASCET-PI)in order to improve quality of life and to improve~     the clinical course of disease.~   "
99446|NCT02265575|"~     One of the leading health issues among patients, particularly children, presenting for care~     in low- and middle-income countries is dehydration. When oral rehydration is not sufficient~     or is clinically inappropriate, rehydration often occurs intravenously. An alternative to~     intravenous rehydration is subcutaneous infusion and - with or without hyaluronidase enzyme~     (or Hylenex) - has been shown in several robust trials in high-income countries to be as~     effective and even safer than intravenous infusion. In this study in western Kenya, the~     investigators propose a first-ever randomized controlled trial to evaluate whether~     hyaluronidase-facilitated subcutaneous infusion can be as effective and safe as IV therapy~     among moderate-to-severely dehydrated patients in low- and middle-income countries.~   "
99447|NCT02265562|"~     Hysterectomy, as any major operation, can cause complications, as hemorrhage which may occur~     in some cases and sometimes requiring blood transfusion. Recent study proved that misoprostol~     success in reducing blood loss during total abdominal hysterectomy when used once before the~     surgery.~   "
99448|NCT02265549|"~     Published prognostic scores have limitations in prediction of long term survival after~     stereotactic radiotherapy for brain metastases. Moreover, no validated tools are available~     for prediction of local failure. The value of radiomics is evaluated in this perspective.~   "
99449|NCT02265536|"~     The main purpose of this study is to learn more about how the investigational drug,~     LY3022855, affects the immune system in participants with advanced breast or prostate cancer~     that has not responded to other treatments. Treatment may last up to 6 cycles (cycle = 6~     weeks).~   "
99450|NCT02265523|"~     The purpose of this investigation is to examine the effect of, and improve patient compliance~     and motivation following total knee arthroplasty; to determine the efficacy of two~     post-surgical exercise programs on knee pain, function, range of motion, strength, and~     swelling (girth); and to establish a panel of biomarkers that will allow: a) early~     identification of patients at risk (i.e. unable to complete post-operative treatment) and; b)~     predict the likelihood of a successful treatment outcome post-surgically.~   "
99451|NCT02265510|"~     This is a study of INCB052793 given to patients with advanced malignancies that will be~     conducted in three phases; Phase 1a (Monotherapy) and Phase 1b (Combination Therapy) and~     Phase 2 (Combination therapy of INCB052793 with azacitidine and itacitinib with azacitidine).~     Phase 1 will have two parts; a dose escalation (Part 1) and an expansion (Part 2).~   "
99452|NCT02265497|"~     Currently there are no official data concerning incidence, progression and prognosis of~     patients with lymphoma in Brazil.This project aims the establishment of a network of 12~     Brazilian Institutions to implement a Lymphoma Registry (RELINFO) with the Brazilian National~     Cancer Institute (INCA) as the Coordinating Center.We intend to develop and implement a~     computerized system for data entry and information management of patients with lymphomas.~     This will enable create a virtual registry of demographic, clinical, epidemiological,~     histopathological, molecular, and therapeutic data. This clinical record must be linked to~     histopathological and molecular diagnosis, allowing institutions that work in the context of~     the public health system have access to new technologies for early cancer diagnosis.We expect~     is that this record reliably portrays the scene of lymphomas in our state and will become a~     management model that can be replicated at the national level. Thus, the implementation of~     RELINFO will strengthen the multidisciplinary diagnosis, promote the standardization of~     clinical record of patients with lymphomas and provide subsidies to cooperative research~     projects between participating institutions.~   "
99453|NCT02265484|"~     After successful screening of liver cirrhosis patients attending ILBS OPD for signs of~     parkinsonism ( tremor, rigidity or bradykinesia, any 2 of 3). Diagnosis of hepatic/cirrhosis~     related parkinsonism will be made. Patients will be randomized into Bromocriptine and~     Placebo. Patients will be followed up every month in OPD (Out Patient Department), ILBS~     (Institute of liver & Biliary Sciences) for 3 months. Detailed neurological examination will~     be done at each visit & UPDRS (Unified Parkinson's Disease Rating Scale ) score will be~     calculated.~   "
99454|NCT02265471|"~     The objectives of this survey are to determine the level of antimicrobial resistance~     knowledge and perception of health care workers (HCW) in France, to measure the impact of~     health care facilities (HCF) and to identify the drivers and barriers to change. To achieve~     this goal, a cross-sectional survey on one day with a self-administered questionnaire and~     semi-structured interviews with HCWs is proposed. This study will be planned in 60 different~     HCFs randomly selected and expected to include of 2,100 to 10,000 respondents.~   "
99455|NCT02265458|"~     Non-invasive ventilation (NIV) might be associated with anxiety, thus leading to NIV failure,~     and intubation. Music therapy has been used in various clinical context, including in ICU~     patients under mechanical ventilation. We aim to evaluate the effect of a musical~     intervention on respiratory comfort during NIV for acute respiratory failure.~   "
99456|NCT02265445|"~     The study aims to evaluate a deescalating therapeutic strategy (switch the carbapenem to~     another beta-lactam for which the isolated pathogen is susceptible) in patients with~     well-defined ESBL-PE infections (usual sites of infections and non severe infections).~   "
99457|NCT02265432|"~     The purpose of this study is to test an intervention which uses a personalized~     mobile-technology based approach that aims to promote physical activity and reduce sedentary~     behaviour in inactive working Singaporean adults.~   "
99458|NCT02265419|"~     Heart-surgery with the use of a heart-lung-machine can trigger the development of a~     full-blown SIRS (Systemic Inflammatory Response Syndrom) with multi organ failure and severe~     sepsis in the course of disease.~      For the treatment of full-blown SIRS extracorporeal treatment like the Cytosorb-Adsorber are~     in clinical testing. The Cytosorb-Adsorber is a CE-signed medical device with approval for~     the treatment of severe sepsis and hyperinflammation. The adsorber remove not-specific~     cytokines and other inflammation mediators from the patients blood.~      In this study (as a case-observation and compassionate use) the effect of extracorporeal~     treatment with the Cytosorb-Adsorber for the reduction of postoperative hyperinflammation and~     SIRS after heart-surgery with use of a heart-lung-machine will be observed.~      The aim of the study is recording the influence of the treatment with the Cytosorb-Adsorber~     on the course of hyperinflammation and multi organ failure in comparison with a historic~     control group.~   "
99459|NCT02265406|"~     Ventilation-associated pneumonia (VAP) is the main site of healthcare-associated infections~     in the brain injured patients, with an incidence rate of 22% to 58%. VAP increases~     morbi-mortality, length of stay in intensive care and overall management costs. The~     prevention of ICU nosocomial infections depends on several measures : orotracheal intubation~     route, maintaining tube cuff pressure between 25 and 30 cm of water (H2O), maintaining a~     semi-seated position >= 30°, nasal and oropharyngeal care at regular intervals, striving to~     avoid unscheduled extubation, and use of a written sedation-analgesia algorithm allowing for~     early weaning from ventilation. Two randomized study show that administration of antibiotic~     therapy after intubation reduces the risk of early VAP incidence. However, in clinical~     practice, its administration solely purposes of limiting VAP occurence is not presently~     recommended. Indeed, to date no placebo blind controlled study was been realized and the fear~     of development of bacterial resistance remains stronger than the efficiency of this~     prevention measure. This aim of the present study is to show by a placebo randomized study~     that 2g of Ceftriaxone within 8 hours post-intubation after a brain injury decrease the risk~     of occurence an early VAP.~      Ancillary study An ancillary study is performed in 2 centres which routinely practice rectal~     swabs at admission and discharge of ICU, to survey intestinal flora (CHU of Angers and CHU of~     Rennes). The goal of this study is to compare the incidence of acquired cephalosporin~     resistant gram negative bacteria at the discharge of ICU between the 2 groups of patients,~     receiving or not ceftriaxone.~   "
99460|NCT02265393|"~     This is a 2-part study of OTO-104 in subjects with unilateral Meniere's disease in the United~     Kingdom. The first part is a randomized, placebo-controlled study comparing the safety~     profile of 2 injections of OTO-104 or placebo spaced 3 months apart. The second part is an~     open-label extension where all subjects will receive an additional 2 intratympanic injections~     of OTO-104 spaced 3 months apart. Each subject will participate on the study for a total of 1~     year.~   "
99461|NCT02265380|"~     A prospective, single-center, open-label, randomized controlled trial to demonstrate the~     safety and efficacy of the OptiVein IV Catheter in the pediatric population. The study~     hypothesis is that OptiVein IV Catheter use will be superior to the control in successful~     venous access after first attempt.~   "
99462|NCT02265367|"~     The purpose of this study is to provide preliminary information assessing if levomilnacipran~     may be effective at increasing smoking cessation rates.~   "
99463|NCT02265354|"~     This study will advance computer tailoring by adapting machine learning collective~     intelligence algorithms that have been used outside healthcare by companies like Amazon and~     Google to enhance the personal relevance of the health communication.~   "
99464|NCT02265341|"~     This pilot phase II trial studies how well ponatinib hydrochloride works in treating patients~     with biliary cancer that has spread to other places in the body and that have alterations~     (fusions) in a gene known as fibroblast growth factor receptor 2 (FGFR2). Ponatinib~     hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth.~   "
99465|NCT02265328|"~     Severe Alcoholic hepatitis (SAH), defined by modified Maddrey's Discriminant Function (DF)~     ≥32, is associated with significant morbidity and mortality. Of the various treatment~     modalities evaluated for treatment of SAH, corticosteroids have been the most extensively~     studied. Five out of 13 RCTs, and four out of 5 meta-analysis have shown a survival benefit~     with corticosteroids, especially in patients with DF ≥32 and/ or encephalopathy.However, the~     role of corticosteroids in SAH still remains somewhat controversial. Corticosteroid therapy~     is not considered the ideal option by all authors because their beneficial effect seems to be~     confined to a highly selected minority group in which the inhibitory effect of~     corticosteroids on liver inflammation is not outweighed by side effects such as weakened~     defence against infections, anti-anabolic effects, and possible ulcer promoting effects. Also~     corticosteroids are contraindicated in patients with renal failure, gastro-intestinal (GI)~     bleed, pancreatitis and active sepsis. Therefore, there have been constant efforts to~     evaluate new therapies for SAH. In a recent trial, combination of glucocorticoids plus~     N-acetylcysteine was found to improve one month survival in patients with SAH, compared with~     glucocorticoids alone. However the 6 month survival was not different in both groups.~      Human Colostrum (HC) and Bovine Colostrum (BC) are rich in protein, immunoglobulin,~     lactoferrin and growth factors. Recent studies suggest that colostrum components,~     Lactroferrin, immunoglobulin and growth factor benefits physically active person and in~     treatment of autoimmune disorders. It is used for the treatment of a wide variety of~     gastrointestinal conditions, including non-steroidal anti-inflammatory drug-induced gut~     injury, H pylori infection, immune deficiency related diarrhea as well as infective diarrhea.~      The guidelines by American College of Gastroenterology and other authors have suggested that~     a combination of CS and other drugs, which have different mechanisms of action, may be more~     beneficial for reducing mortality in SAH. Hence, we plan to conduct this pilot study to~     investigate the efficacy of a novel combination of corticosteroids, and Bovine colostrum in~     the treatment of SAH.~   "
99466|NCT02265315|"~     The purpose of this study is to evaluate the impact of a non-invasive brain stimulation~     technique called transcranial magnetic stimulation (TMS) on voice/speech treatment in people~     with Parkinson's Disease (PD), through the use of speech and voice analysis, examination of~     voice box, and brain imaging methods.~   "
99467|NCT02265302|"~     Study to obtain information about the safety and tolerability of BIIL 248 BS, to find the~     pharmacologically active dose range for the two formulations PSE 1% and WIF tablets by~     determination of the surrogate marker CD11b (= Mac-1) and to obtain preliminary~     pharmacokinetic data as well as first information on food effects after administration of the~     75 mg WIF tablet in healthy male volunteers~   "
99468|NCT02265289|"~     To assess the influence of 75 mg Clopidogrel on the pharmacodynamics and safety of 30 mg~     Lefradafiban tid~   "
99469|NCT02265276|"~     Non Alcoholic Fatty Liver Disease (NAFLD) is considered as the component of metabolic~     syndrome. The prevalence of the same has been increasing rapidly in India, along with an~     increase in the prevalence of diabetes and obesity. Insulin resistance is the key underlying~     pathogenetic mechanism of NAFLD. NAFLD accounts for significant morbidity and mortality and~     the therapeutic options are limited. Insulin sensitizing drugs are used in the management of~     NAFLD.~   "
99470|NCT02265263|"~     The research leading consortium to these results has received funding from the European Union~     Seventh Framework Programme [FP7/2007-2013] under grant agreement no 602461 (www.biocog.eu).~      The investigators will establish valid biomarkers panels (neuroimaging and molecular) for~     risk and clinical outcome prediction of postoperative delirium (POD)/postoperative cognitive~     deficit (POCD) in elective surgical patients (Age ≥ 65 years) in study centers in~     Berlin,Germany (data collection within 5 years after initial hospital stay) and Utrecht, The~     Netherlands (data collection within 1 year after initial hospital stay), thereof~     cerebrospinal fluid (only once on day of surgery in patients with planned spinal~     anesthesia/combined spinal epidural analgesia in n = 200 patients, only in Berlin).~     Post-mortem samples of brain tissue are analyzed in a limited number of voluntary patients,~     only in Berlin.~      A control group of ASA II/III- patients is collected for measuring the learning experience~     during the cognitive testings. The participants are matched on age, education, and gender to~     the study patients. The ASA II/III- control patients receive additionally MRI-scan (3 Tesla)~     at baseline, after 3 months and after 1, 2 and 5 years.~      To analyze scanner variability we additionally measure 20 subjects (Age ≥ 65 years, ASA I and~     II) from Berlin in the MRI scanner (3-Tesla) in Utrecht und vice versa 20 subjects (Age ≥ 65~     years, ASA I and II) from Utrecht in the MRI scanner (3-Tesla) in Berlin.~      A study group (n= 80) and matched control group of (n=80, patients ASA II and III) patients~     is collected for measuring 7 Tesla MRI at two timepoints (Baseline and 90 days).The primary~     endponit of this substudy is gamma amino-butyric acid concentration in CNS after 3-months~     (measured by MRI). A retrospective control group (extracting 800 intensive care unit patient~     data from the patient data management system during the BioCog study period) to analyse~     economic effects that are caused by the implementation of quality indicators in health care.~      An interim-analysis is performed on the primary endpoint after 400 included patients.~      The resulting (multivariate) expert system is expected: 1) to support clinical~     decision-making in patient care, e.g. to balance the individual POD/POCD risk against the~     expected overall clinical outcome of an (elective) surgical intervention, 2) to allow the~     design of more sophisticated and hypothesis-driven clinical studies and drug trials~     (translational research) in the future. The latter will be possible on the basis of~     biomarker-based sub-grouping of patients and a better understanding of relevant~     pathophysiological processes.~      Furthermore, a state-of-the art clinical database and biobank will be created that does not~     yet exist worldwide. Both the expert system and the reference database/biobank will expand~     the leadership of the contributing academic institutions in this particular research area. In~     addition, the newly created biobank will become an integral part of the European Biobanking~     and Biomolecular Resources Research Infrastructure (BBMRI) which allows top address specific~     and hypothesis-driven research questions.~      Most notably, the developed (multivariate) expert system also has the potential for~     commercialization. Possible customers are: 1) physicians and hospital departments being~     involved in pre-surgical decision making, 2) pharmaceutical industry intending to conduct~     biomarker-based drug trials in POD/POCD.~   "
99471|NCT02265250|"~     Cardiovascular disease (CVD) remains the leading cause of death in the United States, and~     improved CVD risk assessment is needed for personalized medicine. Atherosclerosis measures~     including plaque volume and adverse plaque features have prognostic value. Novel techniques~     have been developed for assessing carotid, coronary, and femoral atherosclerosis using~     magnetic resonance imaging (MRI) methods that are rapid and reproducible, have improved~     spatial resolution, and do not require contrast media, making atherosclerosis assessment in~     multiple vascular beds feasible during a single MRI session. This pilot research will provide~     preliminary data to develop an innovative global atherosclerosis measure including carotid,~     coronary, and femoral vascular beds, for assessing cardiovascular risk and for monitoring~     atherosclerosis response to therapy. 20 participants will be recruited in one year.~   "
99472|NCT02265237|"~     The purpose of this study in HCV genotype 4-infected participants with compensated cirrhosis~     is to assess the safety and to compare the percentage of participants achieving a 12-week~     sustained virologic response (SVR12), [HCV ribonucleic acid (RNA) < lower limit of~     quantification (LLOQ) 12 weeks following treatment], to a clinically relevant threshold~     [based on SVR rates for HCV genotype 4-infected participants treated with pegylated~     interferon (pegIFN)/RBV].~   "
99473|NCT02265224|"~     This is single centre, single dose, open, randomised, cross-over, two-stage bioequivalence~     study to compare two different oral formulations of NAC.~      The study has been conducted in healthy volunteers of both genders, in one single dose of~     both formulations.~   "
99474|NCT02265211|"~     This study evaluates a self-help app in the treatment of shyness and social anxiety in~     adults. All participants will be assigned to the treatment group. It is expected that using~     this app will result in a reduction in social anxiety.~   "
99475|NCT02265198|"~     Pulmonary contusion (PC) is a significant problem after blunt trauma that may often lead to~     acute respiratory distress syndrome (ARDS) and in some patients, death. Although the~     pathophysiology is incompletely understood, it is clear that there is a biochemical process~     involving changes in the inflammatory milieu after contusion which occurs in addition to~     simple direct mechanical injury to the lung. The relationship of severity of contusion on~     imaging, disturbances in the inflammatory phenotype, and outcome is unknown. This is a~     prospective, observational study which will evaluate the size and severity of contusion as~     measured on chest computed tomography (CT). Inflammatory mediators will be measured in the~     bronchoalveolar lavage (BAL) and in the serum of patients with pulmonary contusion to define~     the inflammatory nature of the post-contusion lung. The degree of abnormality within the~     inflammatory parameters will be correlated with lung contusion size and subsequent patient~     outcomes. These data will be compared to other patient groups: 1) Trauma patients without~     chest injury who are mechanically ventilated; 2) Uninjured patients undergoing elective~     surgical procedures that will require intubation and mechanical ventilation; 3) Patients in~     the Medical ICU who are mechanically ventilated with acute respiratory failure.~      The hypothesis tested within this study is resolution of lung injury is dependent upon the~     presence of Tregs in the alveolar space.~   "
99476|NCT02265185|"~     Childhood obesity is a major area of concern for health care and public health. Overweight~     children are more likely overweight and obese adults. Chronic health problems associated with~     adult obesity are now occurring more frequently in children. Because of the associated health~     problems and potential for long term struggles with obesity, intervention early in life is~     essential for addressing the obesity epidemic. Some intervention work in this area has~     focused on the pediatric primary care setting in order to utilize the influence and~     credibility of medical providers. Unfortunately, primary care visits are often too short to~     spend a significant amount of time on issues of diet, weight and nutrition.~      There has been very little work exploring the potential of alternative care settings, such as~     the pediatric Emergency Department (ED) in addressing childhood obesity. While provider time~     is also limited in the ED, there is often a considerable amount of downtime during emergency~     department visits that could be valuable time for patient and parent education. There may~     also be an opportunity to reach parents and children in the ED who do not regularly utilize~     primary care. In order to explore the possibility of pediatric obesity interventions in~     Children's Pediatric Emergency Department, we will need to measure the prevalence of obesity~     in the population that utilizes the Children's ED. The height of patients seen in the ED is~     not routinely measured, which makes calculating BMI to determine obesity impossible. This~     study, establishing the prevalence of obesity in Children's Emergency Department will lay the~     groundwork for future work addressing obesity in the ED.~   "
99477|NCT02265172|"~     Many patients with musculoskeletal pain in primary healthcare are referred to orthopaedic~     surgeon, however, a relatively low percentage of these patients are considered suitable for~     orthopaedic intervention.~      Physiotherapists are suitable for musculoskeletal assessments and are used as such in many~     countries i.e. Advanced Practice Physiotherapists or Extended Scope Physiotherapists,~     however, this is not an existing model of care in Sweden. To be able to consider this model~     for implementation in Sweden it is necessary to evaluate it from a healthcare as well as from~     a patient perspective.~      The study is a randomised controlled trial. Overall aim is to evaluate if a orthopaedic~     manual therapy assessment (physiotherapy) assessment of patients referred to orthopaedic~     surgeon bring any changes to referral routines, patient satisfaction and health-related~     variables when compared to standard practice.~   "
99478|NCT02265159|"~     The investigators aim to evaluate cancer control, genitourinary, rectal and overall~     health-related quality of life outcomes and effectiveness of focal therapy for localised~     prostate cancer using High Intensity Focused Ultrasound (HIFU).~   "
99479|NCT02265146|"~     This is a multi-center, investigator initiated study that will prospectively examine~     treatment strategies and outcomes of patients who underwent clinically-indicated Near~     Infrared Spectroscopy (NIRS). The information collected will be used to determine the~     frequency of NIRS imaging performed at the participating sites and to examine the clinical~     outcomes of the NIRS-detected Lipid Core Plaques (LCPs).~   "
99480|NCT02265133|"~     This study is a prospective, single center clinical trial to assess corneal sensitivity and~     nerve fiber morphology in patients with sleep apnea compared to normal controls. Healthy~     volunteers with no history of ocular or uncontrollable systemic disease will be encouraged to~     participate in the study. After execution and review of the consenting procedures, a detailed~     history will be taken and a slit lamp examination performed, verifying ocular health. This~     consists of an examination of both eyes including assessments of ocular lids, lashes, cornea~     and conjunctival evaluation. Corneal touch thresholds will be tested with a Cochet-Bonnet~     aesthesiometer, a standard non-invasive measure of corneal sensitivity. Corneal nerves will~     be imaged using a modified HRT in vivo confocal microscope. The in vivo confocal microscope~     allows for high resolution imaging of the nerve plexus under the corneal epithelium. This~     corneal nerve plexus is responsible for corneal sensitively and changes or loss have been~     established as an early, sensitive indicator of corneal neuropathy. The investigators~     anticipate that this study will require approximately 30 patients for each group and will~     last approximately 12 months for recruitment and completion of subject visit phases. There is~     only one clinical visit designed for this project, unscheduled visits may be scheduled in~     case of an adverse event.~      Patient recruitment will be complete at the one-year time point. At the 14 month time point,~     all data points will have been collected and assessment of the outcome measure (corneal~     sensitivity in sleep apnea patients versus control patients) will be complete.~   "
99481|NCT02265120|"~     Significant developments have led to a dramatic change in recommendations for cervical cancer~     screening. The understanding that the Human Papilloma Virus (HPV) is the cause of nearly 100%~     of cervical cancer cases and the development of new technologies for detection of HPV DNA at~     time of cervical cancer screening, has produced changes in preventive healthcare policy for~     this condition. In an unprecedented event, the American College of Obstetrics and Gynecology,~     the American Cancer Society and the U.S. Preventive Services Task Force recommended dramatic~     and unified changes in screening utilizing this new framework. No studies of significance~     have evaluated (since guideline change in 2013), whether primary care providers find the new~     recommendations authoritative and believe in them, or whether providers understand~     implementation of these new guidelines given the many decades of contradictory and differing~     recommendations. For this study, the opinions of primary care providers who care for patients~     in the 194 federally designated regions of Primary Care provider shortage within California~     will be studied. Using the California Medical Board database of licensed providers, a~     questionnaire will be mailed to a random subset. It is anticipated that the analysis will~     show varying contempt, confusion and compliance with new guidelines exists. Understanding~     these factors will have beneficial health policy implications in terms of overcoming barriers~     to these cost-effective, less intrusive, and more accurate health policy guidelines in the~     prevention and early detection of cervical cancer.~   "
99482|NCT02265107|"~     Objective: To observe the effects of exercise training on vascular endothelial function in~     patients undergoing coronary artery bypass graft (CABG) alone in phase III after six months~     of Cardiac rehabilitation programs (CRP).~      Methods: the investigators contacted all patients undergoing CABG alone in period of 1 year~     to participate in a CRP with duration of six months with three weekly sessions of 1 and half~     hour of the duration. All patients underwent biochemical blood tests, muscle strength testing~     of one repetition maximum (1-RM test) for upper and lower limbs, 6-minute walk test (6MWT),~     and evaluation of endothelial function (using flow-mediated vasodilation).~   "
99483|NCT02265094|"~     The aim of this study is to investigate the neural substrates of associative memory in Autism~     Spectrum Disorder using both behavioural and EEG assessments.~   "
99484|NCT02265081|"~     The proposed study is to evaluate if there are specific factors in the pelvic floor~     functional anatomy which can predict the ability of having a vaginal birth after caesarean~     section.~      Physical characteristics of the soft tissue in the female pelvis play an important role in~     successful vaginal delivery. A tight or less distensible pelvic floor muscles may influence~     mode of delivery, leading to poor labour progression and by compressing foetal head produce~     CTG abnormality such as decelerations, both resulting in caesarean delivery.~      One of the main structures of the pelvic floor, the puborectoalis muscle, facilitates the~     passage of fetal head through the birth canal by stretching and distending. Therefore~     distensibility of the female pelvic floor influences mode of delivery.~      Three hundred patients, in the third trimester of pregnancy, will be recruited via the~     antenatal clinics to minimize any disruption in their pregnancy care provision. Eligible~     participants are pregnant women who had either one or no vaginal births, or one caesarean~     section and who can give an informed consent and maintain their autonomy regarding mode of~     delivery with understanding of the forthcoming study results. Participants will be excluded~     if they sustain any obstetric complications that may impede on time and mode of delivery~     including an emergency prelabour caesarean section.~      Ultrasonographic assessment of the differences in the pelvic characteristics of these women~     will be used to predict a successful of trial of vaginal delivery after caesarean section~     (VBAC) in subsequent pregnancies. The results will be used to better inform whether there is~     a simple (single ultrasound assessment) that can be used to help inform women's choice~     regarding mode of delivery.~      Results from this research could be a pioneering blueprint for further studies, as there is~     very little known about this topic.~   "
99485|NCT02265068|"~     Documentation of long-term data regarding ticagrelor use and evaluation of reasons for~     discontinuation of ticagrelor in patients with ACS~   "
99486|NCT02265055|"~     To observe whether Number of early cleavage embryos can be a predictor for multiple~     pregnancies after ICSI.~   "
99487|NCT02265042|"~     The aim of the study is to investigate whether there is an effect of electrical stimulation~     on the denervated gluteus muscle (buttocks) in individuals with chronic spinal cord injury.~     The expected outcome is an increase in muscle volume and a better pressure distribution~     during sitting. The stimulation of the gluteus muscle is performed daily for 35 minutes over~     a period of six months. The muscle volume and the pressure distribution are measured before~     stimulation, three months after having started stimulation and after six months.~   "
99504|NCT02264821|"~     The aim of this study is to compare effective analgesia with continuous wound infiltration of~     ropivacaine through multi-holed catheter or with morphine 100 mcg added intrathecally to~     spinal anesthesia, after elective Caesarean delivery.~   "
99488|NCT02265029|"~     Fibromyalgia is a common health problem that causes widespread pain and tenderness (sensitive~     to touch). The pain and tenderness tend to come and go, and move about the body. There is no~     cure for fibromyalgia. Complementary and alternative therapy such as acupuncture,~     chiropractic and massage therapy, can be useful to manage fibromyalgia symptoms. Many of~     these treatments have not been well tested in patients with fibromyalgia. Fibromyalgia affect~     3 to 4% of the general population and 14 % of patients with rheumatologic disease.~     Fibromyalgia is most common in women 90 % in many studies. It most often starts in middle~     adulthood. A chronic evolution occured for Fibromyalgic patients with a major alteration of~     quality of life.~      Thermalgi is a randomized, multicentre, open label trial wich aims to evaluate the effects of~     spa therapy in rheumatologia on evolution of disability in daily life of patients with~     fibromyalgia.~   "
99489|NCT02265016|"~     The aim of this study is measurement of expression and activity of RBC eNOS in different~     clinical cohorts of patients with coronary artery disease and acute coronary syndrome and to~     investigate the importance of the NO-stimulated reaction cascade in terms of sGC and PKG.~   "
99490|NCT02265003|"~     The aim of this study is to find out, how far red blood cells reflect age-depended changes in~     endothelial function.~   "
99491|NCT02264990|"~     This is a 2-arm, Phase 3 study to evaluate the safety and efficacy of veliparib plus~     carboplatin and paclitaxel versus the Investigator's choice of standard chemotherapy in~     current or former smokers who are receiving their first cytotoxic therapy for metastatic or~     advanced non-squamous non-small cell lung cancer.~   "
99492|NCT02264977|"~     The purpose of this study is to assess the feasibility of the use of the GORE® TAG® Thoracic~     Branch Endoprosthesis to treat aneurysms involving the aortic arch~   "
99493|NCT02264964|"~     The duration and adverse events of non-cuffed catheter in patients with hemodialysis will be~     investigated by multicenter prospective cohort. Totally, 1,400 patients with chronic renal~     failure requiring hemodialysis will be enrolled. 900 patients will be given right internal~     jugular catheterization, and the other 500 patients unsuitable for right internal jugular~     catheterization will receive femoral catheterizations. Every patient will be followed-up for~     six months. During following-up period, the duration time and adverse events of non-cuffed~     catheter will be recorded in details, including inadequate hemodialysis blood flow, venous~     stenosis, venous thrombosis, infection, catheter thrombosis and so on. The central vein will~     be evaluated by CT Angiography to identify its stenosis at last visit after 6 months. This~     multicentre trial will provide evidence to develop guideline for duration time of using~     non-cuffed catheter.~   "
99494|NCT02264951|"~     This study compared the incretin-releasing effect of C8-diet oil and tributyrin with that of~     20 ml olive oil on a molar basis in human volunteers.~   "
99495|NCT02264938|"~     Purpose: To determine drusen morphology (volume and area) changes in nonexudative age-related~     macular degeneration (AMD) after one year of oral supplementation with AREDS-like~     formulation.~   "
99496|NCT02264925|"~     The objective of this study is to characterize through spectral analysis intra-thalamic local~     field potentials (LFPs) recorded through implanted DBS leads during periods with and without~     tremor in patients suffering from severe essential tremor.~   "
99497|NCT02264912|"~     The ongoing LAPCOR (Laboratory AntiPlatelet efficacy and Clinical Outcome Registry) registry~     was initiated in 2008 at a tertiary care cardiac center, and consecutive patients, who~     underwent intracoronary stent implantation, have been included regardless of whether~     percutaneous coronary intervention (PCI) was performed on urgent or elective basis.Patients~     were included in the registry after having signed an informed consent for participation. No~     exclusion criterion has been applied for the registry participation. Efficacy of P2Y12~     receptor antagonists has been measured by quantitative flow cytometric analysis of~     vasodilator-stimulated phosphoprotein (VASP) phosphorylation according to the manufacturer~     protocol (Platelet VASP; Diagnostica Stago, Biocytex, Asnières, France) on a FACScan flow~     cytometer (Becton Dickinson). Occurrence of major adverse cardiac events at 30 days, 6-months~     and one year follow up has been investigated.~   "
99498|NCT02264899|"~     A Multicenter national longitudinal cohort study including at least 800 individuals recruited~     from French Research Memory Centers and followed up over 36 months and included in Memento.~   "
99499|NCT02264886|"~     The purpose of this research study is evaluate whether it's feasible to give radiation~     therapy using an MRI-guided adaptive technique. MRI-guided adaptive radiation therapy~     involves the adjustment or re-planning of treatment day by day while the participant is~     receiving treatment. The adaptive technique has previously been used in a different fashion~     to adjust the treatment plan after the fact, but using MRI scanning to re-plan treatment~     while the participant is still on the table is a new way of using the adaptive technique.~     This may allow doctors to use more radiation to treat the tumor while better protecting~     normal tissues. A special radiation treatment machine incorporates both an MRI scanner and~     radiation treatment devices so that the planning and treatment can be done using the same~     machine.~   "
99500|NCT02264873|"~     Decitabine is a hypomethylating agent that has shown significant anti-leukemic effect in~     Myelodysplastic Syndrome (MDS) and Acute Myeloblastic Leukemia (AML). This study is based on~     the hypothesis that Decitabine delivered after allo-hematopoietic stem cell transplant (HSCT)~     in patients with leukemia will enhance disease control by the allogeneic immune system and~     lead to a longer disease free survival. The study is designed to provide safety data of~     low-dosing in the post-transplant setting.~   "
99501|NCT02264860|"~     HIV infection causes systemic zinc deficiency and oxidative stress that impairs host immunity~     in the alveolar space.The purpose of this study is to see if taking two nutritional~     supplements, zinc and SAMe (S-adenosylmethionine), can improve lung health and immune~     function in persons with HIV.~      The investigators hypothesize that long-term dietary supplementation with zinc and the~     glutathione precursor SAMe will enhance pulmonary host immune function in HIV-infected~     individuals who do not respond adequately to ART alone.~   "
99502|NCT02264847|"~     In women being treated with medicines to help eggs to grow (called ovulation induction), The~     investigators wish to know whether adding medicines (called ovulation triggers) that help to~     release the egg (ovulation) would lead to more women having babies without causing harm~     compared with not giving them ovulation triggers.~   "
99503|NCT02264834|"~     Assess the impact of instrumentation and caesarean related to dyskinesia by reducing the~     concentration of local anesthetic and therefore the motor block.~   "
99505|NCT02264808|"~     Determine whether the concentrations of UCH-L1 and GFAP measured in umbilical cord blood and~     in blood 0-6 hours postnatal accurately predict the extent of neurodevelopmental deficits~     and/or death at 18-20 months.~   "
99506|NCT02264795|"~     The instillation of local anesthetic into the peritoneum has been found to be safe and~     effective in reducing postoperative pain and morphine consumption after abdominal surgery. A~     review of studies reporting serum levels of local anesthetic after intraperitoneal delivery~     found no cases of clinical toxicity in any of the trials. The studies in this meta-analysis~     did not include post-cesarean delivery pain and there is a lack of data to support the use of~     intraperitoneal local anesthetic after cesarean section.~      The purpose of this study is to assess the efficacy of intraperitoneal lidocaine on~     postoperative pain scores after cesarean delivery. This study will compare a 20ml solution of~     lidocaine (400mg) with epinephrine 5mcg/ml versus normal saline (placebo) instilled into the~     peritoneum at the end of surgery in women undergoing cesarean delivery. The investigators~     hypothesize that intraperitoneal lidocaine will result in lower pain scores, reduce opioid~     consumption and opioid related side effects, and higher maternal satisfaction after cesarean~     delivery.~   "
99507|NCT02264782|"~     This clinical trial studies how well PreView, preventive video education, works in increasing~     rates of breast, cervical and colorectal cancer screening, improving participants' stage of~     change with respect to age appropriate cancer screening and increasing patient-provider~     discussions about prostate cancer screening.~   "
99508|NCT02264769|"~     PostPartum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the~     most commonly used uterotonic drug to prevent and treat PPH in North America. However~     oxytocin has a very short duration of action, requiring a continuous infusion to achieve~     sustained uterotonic activity. Moreover large doses are associated with adverse effects like~     hypotension, nausea, vomiting, dysrhythmias and ST changes. The Society of Obstetricians and~     Gynecologists of Canada (SOGC) has recommended a single dose of 100 mcg of carbetocin at~     elective cesarean delivery to promote uterine contraction. In three studies recently~     performed at Mount Sinai Hospital, the investigators have found no difference in uterine~     contractility between the doses of 20- 120 mcg carbetocin and that the ED90 is 14.8 mcg. Thus~     a larger trial comparing the minimum effective dose determined in the previous three trials~     with the standard 100 mcg dose is necessary to confirm these findings.~   "
99509|NCT02264756|"~     The purpose of the study is to determine whether an antimicrobial stewardship program can~     decrease the length of hospital stay for patients with pneumonia. The antimicrobial~     stewardship program is run by a pharmacist and doctor with extensive training in managing~     infectious diseases. These two health care professionals are responsible for reviewing the~     records of patients admitted to hospital with pneumonia, and then making specific~     recommendations to the patient's attending physician about how to manage antibiotic~     treatment. These recommendations might include discontinuing the antibiotic, or changing the~     way antibiotics are delivered from intravenous form to pill form, among many other potential~     options. The attending physician considers whether these recommendations should be followed~     or rejected. The study has a control group of patients who are not reviewed by the~     antimicrobial stewardship team, and their length of hospital stay will be compared to the~     reviewed group of patients. Any differences between these two groups will be assumed to be~     due to the impact of the antimicrobial stewardship program. So far, no previous study has~     been able to demonstrate that an antimicrobial stewardship program can reduce the length of~     stay of patients admitted to hospital with pneumonia. This study has some important~     differences from previous studies that may make its conclusions more accurately reflect the~     true impact of antimicrobial stewardship programs. The most important difference is how the~     timing of the review is modelled in the analysis of the study results. Because the timing of~     the review varies between patients, with some patients being reviewed at earlier and some at~     later times, this subtle difference, if not accounted for in the analysis, can mask a true~     positive effect of the program on length of stay. The investigators study will account for~     this variation.~   "
99510|NCT02264743|"~     Ultra-low-dose oral E2/D will have more beneficial effects than trans-dermal HRT on lipids~     and insulin resistance in postmenopausal women, whilst adverse effects on coagulation will be~     avoided.~   "
99511|NCT02264730|"~     Phase 1 Single-Arm Study Evaluating ClotFoam as an Adjunct to Hemostasis in Abdominal Surgery~     in Which Liver Bleeding is Encountered.~   "
99512|NCT02264717|"~     1. The primary purpose of this study is to determine the diagnostic accuracy of the CADscore~     System, a new danish technology that records sounds from turbulence of bloodflow in the~     coronary vessels.~      And secondary:~        1. To determine the accuracy of cardiac magnetic resonance imaging (MRI) and single-photon~          emission computed tomography (SPECT), as secondary tests after detection of obstructive~          anatomic coronary artery stenosis by coronary computed tomographic angiography (CCTA).~        2. To examine the patient population for bio-genetic markers related to development of~          arteriosclerosis.~        3. To evaluate virtual fractional flow reserve (vFFR) computed from coronary angiograms.~   "
99513|NCT02264704|"~     This study aims to determine the effect of exercise intensity within a 15 week programme in~     moderately disabled people with multiple sclerosis (MS). Although earlier research has shown~     that exercise is safe and may improve health related factors such as mobility and fatigue,~     the intensity at which exercise offers the most benefit has not yet been defined.~      Participants will be randomly assigned to one of three groups - high intensity, moderate~     intensity or usual care. Participants in the exercising groups (high and moderate intensity)~     will take part in a supervised 15 week cycling exercise programme based in the Douglas Grant~     Rehabilitation Centre. Those assigned to the usual care (control) group will continue to~     receive their usual medical care and will not participate in the exercise programme. The~     acute immune response to exercise will also be measured.~      Participants from all three groups will be monitored regularly. Clinical outcomes of the~     study include immunological markers, exercise capacity, mobility, fatigue, quality of life~     and cognitive ability. These will be measured by a combination of blood tests, physical~     assessments and questionnaires.~      It is hypothesised that high intensity exercise will cause a favourable, anti-inflammatory~     response which will be associated with greater improvements in physical and psychological~     outcomes than both moderate intensity exercise and usual care.~   "
99514|NCT02264691|"~     To identify and understand biologic aspects of severe asthma compared to subjects with mild~     to moderate asthma and subjects without asthma (normal or healthy volunteers).~   "
99515|NCT02264678|"~     This is a modular, phase I/ phase 1 b, open-label, multicentre study of AZD6738 administered~     orally in combination with cytotoxic chemotherapy regimens and/or novel anti-cancer agents,~     to patients with advanced malignancies. The study design allows an investigation of optimal~     combination dose of AZD6738 with other anti-cancer treatments, with intensive safety~     monitoring to ensure the safety of the patients. The initial combination to be investigated~     is AZD6738 with carboplatin. The second combination to be investigated is AZD6738 with~     Olaparib. The third combination to be investigated is AZD6738 with MEDI4736.~   "
99516|NCT02264665|"~     A descriptive, prospective (partly retrospective), multisite, observational study conducted~     in France in adult patients treated for a well differentiated, unresectable or metastatic,~     pancreatic neuroendocrine tumor with disease progression.~   "
99517|NCT02264652|"~     High-Definition transcranial Direct Current Stimulation (HD tDCS)~      Genuine cathodal HD-tDCS will be delivered through High-Definition electrodes that will be~     arranged on the skull according to a 4x1-ring configuration with the central cathodal~     electrode placed over the identified target and surrounding return electrodes forming~     approximately a 5-cm radius ring.~      Aim: To explore whether a novel form of tDCS can be a safe noninvasive treatment that could~     potentially suppress seizures in refractory partial-onset epilepsy.~   "
99518|NCT02264639|"~     This study will be the initial exploration of APL-2 in patients with PNH. The assessments of~     the safety, tolerability, PK, and PD following administration of single and multiples doses~     of APL-2 will guide decisions to further develop the drug.~   "
99519|NCT02264626|"~     In patients undergoing NIV for acute respiratory, lack of tolerance is one of the main reason~     of failure.~      This may result in a poor synchrony between the patient and the machine, leading to gross~     mismatching and potentially to an increased work of breathing.~      The investigators aim to investigate whether in these patients poorly responding to NIV the~     use of a sedation protocol using remifentanil will lead to an improve patient-ventilator~     interaction and better compliance to NIV.~   "
99520|NCT02264613|"~     This study evaluates the anti-tumor effects of ALRN-6924 in patients with advanced solid~     tumors or lymphomas with WT TP53.~   "
99521|NCT02264600|"~     The purpose of this study is to assess apelin level in patients with Willis-Ekbom Disease~     (WED) as known Restless Legs Syndrome (RLS). Cardiovascular complications of WED have been~     reported in recent studies. Increased oxidative stress is thought to play an important role~     in cardiovascular complications of WED patients. Apelin is a novel described antioxidant~     bioactive peptide. The investigators hypothesize that patients with WED have lower plasma~     apelin level than healthy subjects based on presence of oxidative stress of WED.~   "
99522|NCT02264587|"~     The purpose of this study is to evaluate the effects and mechanism of mosapride citrate on~     diabetic gastroparesi.~   "
99523|NCT02264574|"~     An open-label, multi-center randomized, phase 3 study of ibrutinib combined with obinutuzumab~     versus Chlorambucil in combination with obinutuzumab in subjects with treatment-naïve Chronic~     Lymphocytic Leukemia or Small Lymphocytic Lymphoma.~   "
99524|NCT02264561|"~     The purpose of this study is to determine whether caffeine improves attention.~   "
99525|NCT02264548|"~     -  evaluate the safety and toxicity profile of renal radio-ablation in the setting of~          metastatic renal cell carcinoma.~        -  to assess renal function post radio-ablation~        -  Primary and metastatic tumour response to radio-ablation~   "
99526|NCT02264535|"~     This pilot study is designed to explore the optimal concentration and method of Ginkgolides~     Meglumine Injection skin testing and to evaluate the value of skin test in predicting any~     possible allergic reactions to Ginkgolides Meglumine Injection.~   "
99527|NCT02264522|"~     The purpose of this study is to use the photo-plethysmographic [PPG] waveform signal to guide~     the dialysis and ultrafiltration [UF] of chronic maintenance hemodialysis patients, and to~     further the investigators understanding of homeostasis in hemodialysis.~      The investigators hypothesize that the signals generated from the PPG device along with~     traditional monitoring and nursing judgment, will allow experienced, oriented staff to~     anticipate hemodynamic instability, intervene to prevent or mitigate the intradialytic~     hypotention [IDH], forestalling the onset of non-facilitating compensatory reflexes that~     preclude the patient from achieving an appropriate post-dialysis weight consistent with~     euvolemia. Furthermore, it is hypothesized that the nephrologist and staff will be able to~     wean patients from anti-hypertensive medications and craft patient specific dialysis orders~     and UF profiles that achieve consistent, comfortable treatment to appropriate end points.~      The study aims include:~      Aim 1: To confirm the temporal sequence of PPG signals and changes in BP in routine~     hemodialysis.~      Aim 2: To refine further the predictive algorithms of PPG, augmented with continuous cardiac~     event monitoring (pre-intra-post hemodialysis) Aim 3: To develop targeted interventions to~     reverse the cardiovascular stress indicated by the PPG and to maintain perfusion.~      Aim 4: To develop care paths approved by the medical staff and primary care nephrologist~     allowing RNs to respond to signals from the PPG.~   "
99528|NCT02264509|"~     The purpose of this study is to determine the risk factors associated with the occurrence of~     arterial insufficiency in patients with HIV / AIDS, and to identify the prevalence of this~     disease. The estimated prevalence is 10%, similar to that reported in the general population.~   "
99529|NCT02264496|"~     Colorectal cancer is the fourth most common cancer in the UK. Surgical resection is the~     mainstay of curative therapy. With the screening program enabling early detection, surgery~     plays an important role in treatment strategies. Surgery imparts a significant physiological~     and psychological stress on cancer patients.Recent research has demonstrated that a~     fast-track approach utilising regional anaesthesia, early mobilisation and good oral intake~     can improve outcomes by reducing the physiological stress response to surgery. The primary~     objective of this study is to determine whether a defined exercise programme can improve~     recovery and reduce complications after surgery.~   "
99530|NCT02264483|"~     * Hypothesis: There is an underdiagnosis of pneumonia in COPD (Chronic Obstructive Pulmonary~     Disease) exacerbations which could be demonstrated by performing low-dose chest CT.~     Differences in the inflammatory profile in sputum and blood in patients with and without~     pneumonia can be seen.~      * Objective: To assess the degree of underdiagnosis of pneumonia in COPD exacerbations, using~     chest low-dose CT and to compare clinical and inflammatory differences in blood and sputum~     between patients with and without pneumonia.~      *Material and Methods: Prospective observational study including 75 patients with the~     diagnosis of COPD at the time of an exacerbation and with criteria for a respiratory tract~     infection. At the time of inclusion clinical features, blood and sputum analysis, chest X-ray~     and chest low-dose CT are performed. The investigators divide the patients into two groups~     according to the existence of pneumonia and the inflammatory pattern in blood (inflammatory~     markers) and sputum (cell populations and inflammatory markers) is compared between the two~     branches.~   "
122544|NCT01963468|"~     The purpose of this study is to evaluate the effects of early intervention on language skills~     for children with hearing loss.~   "
99531|NCT02264470|"~     Falls after stroke are common. Previous research has shown that almost every other, 48%, of~     patients with a first-ever stroke fell at least once during the first year after stroke (1).~     Moreover, most of the patients fell during the first three months after stroke onset.~     However, the exact time-point for the falls was not analyzed (1). In addition, many patients~     are falling already during hospital stay (2-5). Reducing the number of falls during inpatient~     rehabilitation on a stroke unit is a high-priority mission. Greater knowledge concerning the~     factors that best predict falls is eligible.~      The aim of the study is to analyze the significance of different physiological, psychological~     and medical factors for predicting the risk of falling in patients with stroke per day of~     care at a stroke unit.~   "
99532|NCT02264457|"~     During cataract surgery an artificial lens is implanted in the eye. These artificial lenses~     are called intraocular lenses (IOLs) and there are many different types of IOL designs. Your~     eyes have astigmatism, which is a normal and common characteristic of the eye. If left~     uncorrected the astigmatism would mean that you would need to wear spectacles for viewing~     distance objects. New IOL designs called toric IOLs help to correct the astigmatism to~     improve your vision after cataract surgery. This study has been designed to look at how well~     a toric IOL corrects this astigmatism so that you do not need to wear spectacles for viewing~     distance objects. There are many designs of these toric IOLs and for this study we are~     looking to compare two different designs of toric IOLs by putting one lens in your right eye~     and a different type of lens in your left eye. Both lenses are commercially available and are~     commonly implanted IOLs. Using new non-invasive methods we hope to be able to better judge~     the visual performance of these lenses and the ability of these lenses to correct~     astigmatism. In addition the study will involve imaging and examining the IOLs to determine~     the prevalence of any post-operative complications.~   "
99533|NCT02264444|"~     Essential to laparoscopic operations is adequate visualization. Unfortunately there is no~     grading system to assess the degree or quality of visualization. The primary objective of the~     project is to develop a laparoscopic visualization scoring system. We also intend to~     investigate the effects of neuromuscular blockade agents on visualization.~   "
99534|NCT02264431|"~     The main objective of the study is to identify the determinant of sleep characteristics of~     obese patients attempting a tertiary clinical center for obesity management, including~     bariatric surgery.~      More accurately the questions addressed are:~        -  What are the determinants of the sleep habits (sleep duration, chronotype) and of their~          evolution~        -  What are the determinants of sleep breathing disorders (sleep apnea, obesity~          hypoventilation syndrome) and of their evolution~   "
99535|NCT02264418|"~     The purpose of this first-in-human study is to evaluate the safety and tolerability of~     escalating doses of ODM-203 in subjects with advanced solid tumours and to determine the~     maximum tolerated dose and dose limiting toxicities.~   "
99536|NCT02264405|"~     To assess the effectiveness of Autologous Hematopoietic Stem Cell transplantation (AHSCT) for~     early severe or rapidly progressive Systemic Sclerosis (SSc) as currently performed by~     different study protocols used across Europe in various EBMT centres through the careful~     recording and analysis of routinely collected clinical and biological data.~   "
99537|NCT02264392|"~     Standard treatment for a soft tissue abscess involves incision over the area of maximum~     fluctuance with drainage of purulence from the abscess cavity. The use of bedside ultrasound~     to guide this drainage has the potential to improve treatment outcomes by ensuring complete~     drainage of the cavity.~      Our hypothesis is that the use of ultrasound for guidance of incision and drainage of soft~     tissue abscesses will decrease treatment failure rate compared to standard blind incision and~     drainage.~      This hypothesis will be tested utilizing a blinded, randomized trial comparing standard~     incision and drainage to ultrasound guided incision and drainage.~   "
99538|NCT02264379|"~     The purpose of this study is to evaluate the outcomes of patients treated with an high dose~     radiation regimen using either stereotactic hypofractionated or normofractionated~     radiotherapy for oligometastatic prostate cancer and to establish efficacy (producing a~     desired result or effect) and safety in this setting.~   "
99539|NCT02264366|"~     The ACCELERATION (ACtivity, smoking Cessation, healthy Eating and aLcohol Education,~     inteRvention, and motivATION) Program is a collaborative project in cancer and chronic~     disease prevention that has been designed by and will be delivered amongst cardiopulmonary~     rehabilitation and prevention programs and cancer centres in Ontario (ON), British Columbia~     (BC), Quebec (QC) and Nova Scotia (NS). This project is being funded by the Canadian~     Partnership Against Cancer, Health Canada and Heart and Stroke Foundation of Canada and in~     the amount of $2.4M over a 3 year period (October 2013 - September 2016). The ACCELERATION~     Program is a 12 week structured model of behavioural interventions and education around~     self-management and prevention that aims to access readily available and referable people for~     primary prevention intervention.This program aligns with current provincial, national and~     international chronic disease prevention and management strategies. The goal of the~     ACCELERATION program is to measurably and effectively change the risk factors and health~     behaviours known to impact cancer and other chronic diseases. Specifically we will aim to~     increase physical activity, reduce smoking, encourage healthy eating, and moderate alcohol~     consumption in about 3,000 participants across Canada over 3 years.~   "
99540|NCT02264353|"~     The investigators hypothesis is that obstructive sleep apnea (OSA) patients with a low~     arousal threshold may wake up too early during a respiratory event, before upper airway~     muscles can be activated to achieve stable ventilation. Thus, strategies to manipulate the~     respiratory arousal threshold could potentially improve the quality of sleep and sleep~     disordered breathing. Agents that raise arousal threshold are therefore likely to benefit~     some patients with OSA. The overall goal of this project is to determine the importance of~     the arousal threshold in OSA, determine which patients might benefit from a raised arousal~     threshold, and test this hypothesis by using pharmacological manipulation of the arousal~     threshold to achieve this goal.~   "
99609|NCT02263456|"~     The purpose of this study is:~        -  to compare the pharmacokinetics of Replenine®-VF and Replenine® or any other high purity~          Factor IX concentrate, when given as a bolus dose of 75IU/kg.~        -  to compare the 1st and 2nd pharmacokinetic assessments on Replenine®-VF (conducted 3~          months apart) and recovery if patients changes batches.~        -  to evaluate Replenine®-VF in terms of clinical tolerance and safety in patients with~          severe haemophilia B.~   "
99541|NCT02264340|"~     Tension headache is a common disabling disease and a worldwide public health problem. This~     research tries to demonstrate the efficacy of physical therapy, based on cervical training~     and postural self-correction instructions, which aims to increase the positive results~     obtained from traditional relaxation techniques (Schultz Autogenic Training). University~     students are selected, because headaches are very common in this sector of the population.~     The design is a non-pharmacological randomized controlled trial, with blinded evaluation of~     the response variables. The investigators compare two independent samples. One of them~     receives an only treatment (Autogenic Training) and the other group receives a combined~     program (Autogenic Training + specific cervical exercises and postural correction). Pain~     parameters (frequency, intensity and duration) and drug consumption are measured before~     treatment, and then, at 4 weeks and 3 months, to value the results.~   "
99542|NCT02264327|"~     Clinical social workers, doctors, outreach workers, and all other staff providing direct care~     to vulnerable populations face multiple challenges in obtaining and maintaining training and~     implementing evidence based practices in diverse community settings. Motivational~     Interviewing is a well-established evidence based practice that is challenging to implement~     across programs and agencies because it requires that skills gained from training be~     reinforced as a service provider employs the practice.~      This study builds on findings from a Phase I study. With funding from a Phase I Small~     Business Innovation Research grant from the National Institute of Health, the Center for~     Social Innovation developed the Motivational Interviewing Simulator: An Experiential Online~     Training Tool. The interactive, case-based, multiplayer web-based game allows service~     providers to deepen their skills in Motivational Interviewing (MI), a widely recognized~     evidence-based practice that supports people to make positive behavior changes related to~     health, wellness, mental illness, and addiction.~      The Phase II randomized controlled trial's primary aim is to assess the relative~     effectiveness of three interventions (MI Training Only; MI Training + eBook; MI Training +~     SIM) in increasing provider MI knowledge and skill retention over time.~      During Phase II of this study, we will recruit 180 providers from 18 community agencies~     serving individuals who live in supportive housing, many of whom have histories of mental~     illness, addiction, homelessness, and medical problems. After receiving a standardized~     two-day onsite MI training, participants will be randomized into one of three conditions: 1)~     MI Training Only; 2) MI Training + eBook (an online comparison with comparable information to~     the Simulator without the interactive elements); or 3) MI Training + Simulator. The~     longitudinal, mixed methods study will assess providers' acquisition and retention of MI~     knowledge and skills through surveys and coding of standardized client interviews; barriers~     and facilitators of MI implementation via focus groups; organizational-level data via key~     informant interviews and site visits; and client outcomes for 3,600 clients through surveys,~     administrative, data and focus groups.~   "
99543|NCT02264314|"~     Hearing loss is the third most common chronic condition in over 65 years people, it is~     estimated that 77.8% of older adults suffer from it. However, there are reports of adherence~     to the use of hearing aids of only to 40%. The objective of this project is to measure the~     effectiveness of a tele-educative intervention to improve adherence to the use of hearing~     aids. A randomized controlled trial was performed. The active branch consists of the~     implementation of an educational program called Active Communication Education, consisting of~     4 sessions with a trained rehabilitator. Participants will be also monitored by telephone~     headset use by personnel trained for three months. The control arm will consist of the usual~     care received by these patients. All participants will be assessed at home at 3, 6, 9, and 12~     months after randomization.~   "
99544|NCT02264301|"~     The purpose of this study is to evaluate the effect of Qingkailing injection versus Puerarin~     injection on withdrawal rate of corticosteroids in patients with active rheumatoid arthritis.~   "
99545|NCT02264288|"~     The PDA-002-DFU-002 trial is a Phase 2, multicenter, randomized, double blind, placebo~     controlled, dose range finding study. The study will enroll approximately 133 subjects in~     four treatment groups. The primary objective of the study is to assess the efficacy and~     safety of PDA-002 administered intramuscular (IM) in subjects who have DFU with and without~     PAD. The secondary objective is to explore potential clinical efficacy by assessing changes~     in vascular parameters such as Ankle-Brachial Index and Toe-Brachial Index (ABI and/or TBI),~     Transcutaneous oxygen measurements (TcPO2).~   "
99546|NCT02264275|"~     The purpose of this study is to determine if aerobic exercise training can serve as~     comprehensive palliative care, whereby enhancing cardiovascular fitness, mitigating~     depressive symptoms and augmenting sleep while bolstering health related quality of life in~     youth with Crohn's Disease and Ulcerative Colitis.~   "
99547|NCT02264262|"~     Activation of the sympathetic nervous system is associated with increased risk of ventricular~     arrhythmias and sudden cardiac death (SCD). Development of simple, noninvasive, reliable~     tools to measure sympathetic outflow in human subjects is therefore highly desirable.~      Microneurography is the current gold standard measurement technique, whereby multiunit~     postganglionic sympathetic nerve activity is recorded with tungsten ultrafine microelectrodes~     inserted selectively into nerve fascicles of the peroneal nerve. Though this technique is~     considered extremely safe, and has been used successfully for decades in human translational~     physiology experiments, it has not been adopted for routine clinical assessment due to the~     requirement for sophisticated equipment and specific technical training and skills.~     Alternatively, many have adopted heart rate variability as a simple, noninvasive technique~     for assessing sympathetic nerve activity. However, heart rate variability does not directly~     measure sympathetic nerve activity, and there is much debate in the literature as to the~     exact source of sympathetic nerve traffic. For example, many believe it is an accurate~     reflection of cardiac sympathetic nerve activity, but does not accurately reflect changes in~     muscle or skin sympathetic nerve activity.~      To address these limitations, the investigators have developed a simple, noninvasive~     technique to measure sympathetic nerve activity using surface electrodes.~      Despite its great promise, this new approach has not yet been directly validated. The purpose~     of this study is therefore to validate this new technique (refered to as EKG-NA) against the~     current gold standard measurement technique, microneurography.~   "
99548|NCT02264249|"~     The purpose of this study is to determine residual gastric volume and residual gastric pH in~     patients undergoing combined EGD and colonoscopy comparing the standard single dose prep with~     the split dose bowel preparation and same day bowel preparations.~   "
99632|NCT02263157|"~     The study is designed to evaluate the association between nosocomial bloodstream infection~     and the occurrence of thrombocytopenia in surgical critical ill patients.~   "
99633|NCT02263144|"~     The purpose of this prospective, non-interventional study is to validate the Narrow Band~     Imaging International Colorectal Endoscopic (NICE) classification for differentiating~     subcentimetric hyperplastic and adenomatous polyps by using Fuji Intelligent Color~     Enhancement (FICE) technology with high-definition without optical magnification.~   "
99634|NCT02263131|"~     The purpose of this study is to evaluate the safety and immunogenicity of IL-YANG Inactivated~     Split Influenza Vaccine (IL-YANG FLU Vaccine Prefilled Syringe INJ.) administered as a single~     intramuscular injection.~   "
99549|NCT02264236|"~     The overarching purpose of this study is to evaluate the clinical efficacy of an~     investigational agent, P10s-PADRE, a peptide mimotope-based vaccine, in combination with~     standard-of-care (SoC) treatment in subjects with advanced-stage (i.e., metastatic) Lung~     Cancer. Vaccine will consist of P10s-PADRE admixed with an adjuvant, MONTANIDETM ISA 51 VG.~     Up to one hundred fifty (150) subjects with advanced-stage Lung Cancer of any histologic type~     will be enrolled for this vaccine trial.~      This single-arm, multi-site trial is designed to evaluate the therapeutic benefits of the~     vaccine in subjects with advanced-stage lung cancer. The primary objectives of the study are:~     (1) to monitor the safety and tolerability of the vaccine when it is administered in~     combination with SoC therapy; and (2) to determine whether immunization with vaccine can~     successfully elicit a robust immune response in subjects with advanced-stage lung cancer.~   "
99550|NCT02264223|"~     Previous literature has shown that the molecular form of isoflavones (as aglycones or~     glycosides) and food matrices can influence the bioavailability of these compounds in humans~     and hence their efficacy. To determine the effects of processing and food matrices on the~     bioavailability of active compounds derived from red clover the investigators will execute a~     5 phase, cross-over design, open label, RCT using 20 healthy women aged between 18 to 40~     years. Participants will receive 5 different formulations of red clover and bioavailability~     will be monitored in blood plasma using LC-MS.~   "
99551|NCT02264210|"~     This phase II trial studies how well icotinib works in treating patients with completely~     resected stage IB NSCLC harboring EGFR mutation.~   "
99552|NCT02264197|"~     Aim of this trial is to investigate the single dose pharmacokinetics and the effect of food~     on single dose of 160 mg 245 CL (two 80 mg tablets) as well as its safety~   "
99553|NCT02264184|"~     Study to investigate the effect of CYP2D6 inhibition by paroxetine on the single oral dose~     pharmacokinetics of tamsulosin and to investigate the effect on safety and tolerability~   "
99554|NCT02264171|"~     Study to investigate the effect of CYP3A4 inhibition by ketoconazole on the single oral dose~     pharmacokinetics of tamsulosin and to investigate the effect on safety and tolerability~   "
99555|NCT02264158|"~     Assessment of the influence of telmisartan, lacidipine and their combination on the QTC~     interval of the ECG~   "
99556|NCT02264145|"~     The study objective is to determine the effect of the ethanolic solutions inhaled from the~     Metered dose inhaler (MDI) (15.5 mg, 31.2 mg and 62.4 mg of ethanol) and from Respimat® (18.4~     of ethanol) on the breath alcohol measurements in healthy volunteers.~      Secondary aim is to determine the linear dose-effect for the HFA 134a-MDI doses. An open,~     randomized, four-way-cross-over design is chosen. The randomization is balanced and~     stratified in accordance with predicted values of the volunteers of Total Lung Capacity (TLC)~   "
99557|NCT02264132|"~     The objectives of this study were to investigate relative BA at steady state and to~     investigate dose proportionality of pharmacokinetic parameters~      Relative BA at steady state:~        -  Pramipexole 0.375 mg ER tablet q.d. versus pramipexole 0.125 mg IR tablet t.i.d.~        -  Pramipexole 1.5 mg ER tablet q.d. versus pramipexole 0.5 mg IR tablet t.i.d.~      Dose proportionality of pharmacokinetic parameters:~      · Pramipexole ER dosages from 0.375 to 1.5 mg q.d.~   "
99558|NCT02264119|"~     Study to assess the absorption of 20 mg Lefradafiban in two formulations, each under~     physiological conditions and with 40 mg Pantoprazole~   "
99559|NCT02264106|"~     To assess the absorption of 30 mg Lefradafiban in two formulations, each under physiological~     conditions and with 40 mg Pantoprazole~   "
99560|NCT02264093|"~     To investigate the effects on airway lumen of talsaclidine in combination with propranolol~     and of talsaclidine and propranolol given as monosubstances~   "
99561|NCT02264080|"~     Study to assess the pharmacokinetics and safety of WAL2014 capsules administered orally as a~     multiple dose to healthy adult male volunteers in double blind manner.~   "
99562|NCT02264067|"~     To assess the pharmacokinetics and safety of WAL2014 capsules administered orally as a single~     dose to healthy adult male volunteers in double blind manner.~   "
99563|NCT02264054|"~     Study to investigate metabolism, pharmacokinetic, safety and tolerability of talsaclidine.~   "
99564|NCT02264041|"~     Study to investigate the effect of cytochrome P 450 3A4 inhibition by itraconazole on the~     single dose pharmacokinetics of cilobradine~   "
99565|NCT02264028|"~     -  To investigate absorption, metabolism and excretion of [14C]-DK-AH 269 CL after oral and~          intravenous administration in healthy volunteers~        -  To assess the safety and tolerability of DK-AH 269 CL after oral and intravenous~          administration to healthy volunteers~   "
99566|NCT02264015|"~     Incidence of visual phenomena, heart rate at rest, safety (with particular emphasis on QT~     analysis of ECGs), and pharmacokinetic parameters~   "
99567|NCT02264002|"~     Pharmacodynamic effects on heart rate (HR) at rest and during exercise and on flicker fusion~     frequency (FFF), FFF method evaluation~      Safety, tolerability and pharmacokinetics of cilobradine~   "
99568|NCT02263989|"~     Study to investigate the bioequivalence of the 40 mg telmisartan film-coated tablet vs. the~     conventional 40 mg telmisartan tablet~   "
99569|NCT02263976|"~     Main study: To investigate safety, tolerability, pharmacodynamics (PD) and pharmacokinetics~     (PK) of BEA 2180 BR Sub-study; To investigate whether treatment with 36 μg tiotropium bromide~     is able to protect of methacholine-induced bronchoconstriction compared to baseline~     (methacholine challenge at screening).~   "
99570|NCT02263963|"~     The purpose of the study is to evaluate the effectiveness of EXPAREL in a transversus~     abdominis plane block by assessing the demand of postoperative narcotic, length of hospital~     stay and incidence of postoperative complications.~   "
99635|NCT02263118|"~     The purpose of this study was to determine whether exposure to m-health platforms promoting~     recommended breastfeeding practices was effective in transmitting the exclusive breastfeeding~     message to participant mothers, and in improving weight evolution of infants.~   "
99684|NCT02262481|"~     The purpose of this study is to evaluate the effect of oral progesterone supplementation in~     preterm labor on the prevention of recurrent uterine contraction and prolonging pregnancy~     period, and its side effect.~   "
99685|NCT02262468|"~     assess results of metal on metal hip replacements carried out at warwick hospital~   "
126719|NCT01908816|"~     The pupose of this study is to evaluate the safety and the efficacy of ranibizumab in rare~     VEGF driven ocular diseases.~   "
99571|NCT02263950|"~     This clinical trial will assess whether a medicine called artemether, currently used at a~     lower dose to treat malaria, could also be useful in treating cancer. For this trial, the~     medicine is given in a new way, as a spray under the tongue. This delivery has several~     advantages, including better absorption into the body and it may be easier for people to~     take. It will be prescribed to consenting patients with advanced solid tumours, every day for~     4 months, either once or twice a day. (For this study 'advanced tumour' will mean there are~     no other effective standard therapy options available to the patient).~      The dose will be decided in Phase 1 of the study by initially testing 3 different doses of~     the medicine in up to 21 different cancer patients, to make sure it is not too toxic or~     causes any side effects.~      After this, the highest safe dose identified in the first phase will be tested in up to 66~     cancer patients in Phase 2 of the study, to see if the medicine is able to reduce the size of~     their tumour or slow down its growth.~   "
99572|NCT02263937|"~     This trial aims to collect pilot data to explore whether bilateral deep brain stimulation~     (DBS) of the Nucleus Basalis of Meynert (NBM) has beneficial effects on memory and thinking~     impairments among individuals with Dementia with Lewy Bodies (DLB).~   "
99573|NCT02263924|"~     Phase III, single-centre, double-blind, randomised, placebo-controlled, parallel-group trial~     to evaluate the efficacy and safety of oral Vitamin E (Mixed Tocotrienol) for 6 months in~     patients with moderate ischemic stroke.~      150 patients will be recruited and randomized to receive either placebo or mixed tocotrienol~     200mg twice a day for 6 months. Patients will be followed up and assessed on their functional~     recovery.~   "
99574|NCT02263911|"~     The purpose of this study is to understand the relationship of 3 different dosage forms of~     baricitinib. This study will also explore the effect of food on how the body absorbs~     baricitinib. This study will last about 5 weeks, not including screening. Screening is~     required within 28 days prior to the date of first dosing.~   "
99575|NCT02263898|"~     This phase II trial studies intermittent dosing of BRAF inhibitor LGX818 (encorafenib) and~     MEK inhibitor MEK 162 (binimetinib) in treating patients with melanoma that has spread to~     other parts of the body (metastatic) and have a BRAF V600 mutation. LGX818 and MEK162 may~     stop the growth of tumor cells by blocking different enzymes needed for cell growth. Giving~     LGX818 and MEK162 with breaks between each course (intermittently) may help delay the time~     when tumors become resistant to the drugs.~   "
99576|NCT02263885|"~     The proposed study will evaluate the safety, and initial efficacy of using the ExAblate~     Transcranial to create a unilateral lesion in the globus pallidus as an adjunct to PD~     medications in subjects who are over 30 years of age and considered medication-refractory~     with advanced idiopathic Parkinson's disease (PD).~   "
99577|NCT02263872|"~     In this double blind randomised controlled pilot trial the investigators aim to determine the~     efficacy of minocycline as an adjunct to treatment as usual in patients with major depressive~     disorder. The investigators hypothesize that the multiple neuroprotective effects of~     minocycline will lead to an improvement in depressive symptoms in participants that were~     given minocycline plus treatment as usual~   "
99578|NCT02263859|"~     The purpose of this study is to evaluate the benefits and risks of hypoglossal nerve~     stimulation with the ImThera Medical aura6000 System as a potential therapeutic option for~     individuals with moderate to severe OSA that have failed or do not tolerate PAP.~   "
99579|NCT02263846|"~     This study is to investigate sex hormones levels of Chinese patients with invasive breast~     cancer.The aim is to analyze biochemical monitoring results of premenopausal and~     postmenopausal patients to facilitate determination of menopausal status and propose clinical~     application.~   "
99580|NCT02263833|"~     This national study was a post-marketing surveillance study conducted in Korea from 29 August~     2008 to 28 August 2012 to meet local regulatory requirements for Mircera~     (monopegylated-epoetin beta). Prospective participant-based data collection was evaluated for~     safety/risk assessments and effectiveness. No specific study-related procedures are required.~     Participants were to be followed up as long as possible at the physician's discretion.~   "
99581|NCT02263820|"~     Contrast-induced acute kidney injury (CI-AKI) has been recognized as the third most common~     cause of hospital acquired AKI, after hypotension-associated hypo-perfusion and~     post-operative AKI. The development of CI-AKI after cardiac catheterization is associated~     with a significant increase in both short-term and long-term mortality and morbidities, as~     well as an increase in length of stay and cost.~      The only marker of renal function that has predictive ability is creatinine and it has~     significant limitations in identifying patients who will develop AKI. Therefore, a diagnostic~     test for predicting CI-AKI risk would have widespread clinical utility.~      The primary purpose of this study is to measure the association between baseline expression~     of senescence markers in blood using SenesceTest and the occurrence of CI-AKI post cardiac~     catheterization.~   "
99582|NCT02263807|"~     Patients aged 12 - 30 years, with recurrent patella dislocations, are consecutively included~     into a randomized prospective study. This study addresses two forms of treatment for~     recurrent patella dislocation. One group is offered reconstruction of the medial~     patellofemoral ligament (MPFL), the second group is offered a standardized training program.~     70 patients are evaluated in the study. 75 of those fulfilled the inclusion criteria and are~     included in the study currently.~   "
99583|NCT02263794|"~     Patients in London and Hamilton with severe asthma who are deemed eligible by a respirologist~     to undergo bronchial thermoplasty treatment will be randomized to image-guided or~     conventional bronchial thermoplasty using hyperpolarized noble gas imaging.~   "
99584|NCT02263781|"~     Evaluation of PREPL activity in healthy controls and known or possible PREPL deficient~     patients~   "
99585|NCT02263768|"~     Objectives: To assess the effectiveness of two recall intervals on dental caries incidence~     (primary outcome) in preschool children with low and moderate caries risk. The level of~     anxiety, oral health related quality of life (OHRQoL), time and cost (secondary outcomes)~     according to each interval will also be assessed. Methods: The sample will consist of 224~     children between 3-5 years of age, of both genders, with low and moderate caries risk~     according to the clinical criteria adapted from the Secretary of Health of São Paulo.~     Children will be randomly allocated into two study groups: Group 1 (G1) - oral clinical~     examination + orientation for oral health and diet on the recall of 12 months; and Group 2~     (G2) - oral clinical examination + orientation for oral health and diet on the recall of 18~     months.~   "
99586|NCT02263755|"~     According to the World Health Organization about 1,400,000 deaths reported annually, are~     related to chronic liver disease. Chronic liver disease is very prevalent in South Korea,~     placing a large economic burden nationwide. Subsequently, an effective and systematized~     approach to managing chronic hepatitis is imperative in Korea.~      The natural history of chronic liver disease differs greatly according to race and ethnicity.~     However, there is scarcity of epidemic data on chronic hepatitis based on Korean patients.~     Therefore, the investigators plan to establish a retrospective and prospective multicenter~     cohort for chronic hepatitis B based on Korean patients that may be utilized for various~     future clinical studies on chronic hepatitis B in Korea, and thereby serve as a basis for the~     establishment and distribution of clinical guidelines for Korean patients with chronic~     hepatitis B, as part of a nationwide project supported by the Centers for Disease Control~     (CDC), Korea.~      The investigators plan to collect 500 cases as have been advised by the CDC during the study~     period (September, 2014-March, 2015) from 4 tertiary hospitals located in Korea. In the past~     5 years, there have been about 800 subjects with chronic hepatitis B who have undergone liver~     fibroscan and liver biopsy from these 4 institutions. The investigators plan to register~     available cases retrospectively from those who are available to agree to give written~     informed consent to participate in this study, and to register the remaining numbers of cases~     prospectively, according to the inclusion and exclusion criteria.~   "
99587|NCT02263742|"~     This project aims to study health outcomes of individuals with mental illness attending a~     co-located primary health care center in a mental health center. This study uses mixed~     methods to collect a range of information about who chooses to use what Wellness Center~     services and in what combinations, with what short and longer-term effects and with what~     outcomes.~      Based on participant interviews, identify barriers to and facilitators of access, service,~     and improvements in person-centered outcomes and elicit suggestions for enhancing health care~     outcomes and choice.~      Collaborate with persons in recovery in using the data collected through Aims 1 and 2 to~     develop and pilot the effectiveness of a new peer-led community based intervention in~     enhancing access and choice and improving person-centered health outcomes.~   "
99588|NCT02263729|"~     The goal of this study is to determine safety and tolerability of Losartan when used for~     treatment of an acute grade II or III hamstring strain and determining the effect of losartan~     on recovery of hamstring muscle function. Subjects will be adults age 18-35 with grade 2 or 3~     hamstring injury who participate in Level 1 athletics or have a similar physical work load~     (e.g. military personnel). Military personnel will only be recruited at Brookings Medical~     Institute. Subjects will undergo examination, MRI, and functional assessment before, during,~     and after 4 weeks of losartan (50mg QD) or placebo.~   "
99589|NCT02263716|"~     This study is to determine whether accelerometry can be used to measure physical activity~     occurring during routine clinical care in a diverse population of patients with medical or~     surgical critical illness.~   "
99590|NCT02263703|"~     Genital HPV is the necessary cause for cervical cancer, as well as a major contributing cause~     of several other cancers and conditions. There are now effective vaccines against the main~     oncogenic HPV types, HPV16 and 18.~      Most research and discussion has focused on targeting the vaccine to young women and older~     adolescents. Based on this, a national free HPV vaccination program for adolescent girls~     commenced in 2007, in Australia. However, at the time of commencement, there had been no~     research on the use of this vaccine in immunosuppressed. Therefore, information on the~     immunogenicity, safety and duration of efficacy of HPV vaccine when administered to~     immunosuppressed children is needed. This trial looked at a 3 dose schedule of quadrivalent~     HPV vaccine in a range of immunosuppressed children, with the endpoint being immunogenicity,~     followed for 5 years for duration of immunity.~   "
99591|NCT02263690|"~     92 patients in treatment with intravitreal injections were randomized to 1 of 3 groups:~     proparacaine 0.5% drops (Group Drops), proparacaine 0.5% drops plus subconjunctival lidocaine~     (Group SC), or 2% lidocaine gel (Group Gel). Patients were asked to score their pain~     experience using a visual analogue scale (VAS), a scale of 0 to 10, immediately following the~     injections as well as 10 minutes, 1 hour, 6 hours and 24 hours after. Patients also graded~     the overall injection experience as Excellent, Very Good, Fair, Poor or Awful. The physician~     evaluated the patient's eye movement during intravitreal injection in three levels: none or~     minimal (0), not compromising the injection (1), compromising the injection (2).~   "
99592|NCT02263677|"~     Participants will be persons with type 2 diabetes who are likely to have fatty liver disease.~     The investigators think that this medication will reduce fatty liver.~      The investigators will use an MRS (a non invasive method using magnets) to evaluate liver fat~     before and after subjects take a diabetes medication. The investigators will also collect a~     small amount of blood to measure liver, kidney and hormone functions. This will be done 4~     times. Also, at the time of the subject gets their first dose of medication they will have a~     DEXA (low exposure x-ray often used in clinical practice to measure bone density and body~     composition).~      The goal of all of these studies is to determine whether the study drug lowers liver fat.~   "
99606|NCT02263495|"~     Metastatic breast cancer (MBC) is an incurable disease and is needed to improve effective~     chemotherapy. Paclitaxel plus Gemcitabine (PG) combination chemotherapy is one of the~     preferred chemotherapeutic regimens for patients with MBC, and was found to be proper as a~     maintenance chemotherapy regimen with survival benefit and feasible toxicity profile as shown~     in a large phase III KCSG (Korean Cancer Study Group) study (Park Y et al. J Clin Oncol~     31(14):1732, 2013).~      Eribulin mesylate is a microtubule-targeting agent that showed improved overall survival~     benefit as monotherapy for MBC patients as a new chemotherapeutic agent after failure of~     anthracycline and taxane in EMBRACE study (Cortes J et. al. Lancet 377:914-923, 2011).~     Eribulin was also reported its promising efficacy in another randomized phase III study that~     demonstrated eribulin as efficacious as capecitabine (Kaufman P et. al. Abstr# S6-6, SABCS~     2012). Both study results showed potential clinical benefit in patients with triple negative~     MBC (TNBC). Thus, eribulin combined with gemcitabine may be a new potential regimen for early~     line therapy in patients with metastatic breast cancer.~      Furthermore, eribulin may have rational benefit compared with paclitaxel in terms of~     neurotoxicity. Although there is no direct evidence that eribulin has better neurotoxicity~     profile than taxane, eribulin tended to show less neurotoxicity compared with ixabepilone in~     a phase II trial (Vahdat, L et al. 2011 SABCS). Eribulin has no worsen toxicity as compared~     to paclitaxel. Therefore, EG may have less neurotoxicity comparing to PG.~      In phase I trial, eribulin in combination with gemcitabine was feasible in patients with~     advanced solid tumor treated with chemotherapy (< 3 lines) (Goel R, et al, 2009 ASCO).~      Based on this rationale, the investigators are to conduct randomized phase II study comparing~     EG chemotherapy with PG chemotherapy for patients with HER-2 negative MBC as first-line~     chemotherapy.~      A total of 112 patients will be recruited. Patients will be randomized to a treatment arm by~     permutated method. The randomization ratio is 1:1. This study is multi-center, randomized,~     open label study.~   "
99674|NCT02262611|"~     Study to obtain long-term data on effects, safety and tolerability in routine medical~     practice and to investigate the potential of telmisartan to prevent secondary organ damage~   "
99593|NCT02263664|"~     Microcirculatory alterations occur in critically ill patients and those undergoing major~     surgeries. The severity of perioperative microvascular alterations appear to be related to~     the severity of organ dysfunction after surgery. Non-cardiac thoracic surgeries comprise a~     subgroup of high risk surgical procedures which have the potential to significantly affect~     and impair microcirculatory function but this patient population has not been well studied.~     Esophagectomy surgery in particular produces a profound systemic inflammatory response which~     correlates with a number of adverse outcomes. It is likely, though unproven, that~     microcirculatory derangements may underly these phenomena. Though the study of~     microcirculatory dysfunction in thoracic surgery is in its infancy, the body of available~     evidence at this point supports the following hypotheses; that microcirculatory derangements~     and dysfunction 1) occur during major surgeries including transthoracic esophagectomy 2) may~     be related to SIRS, 3) may predict adverse outcomes, and 4) may be amenable to modification~     via specific therapies.~      We propose a prospective observational study to determine the effects of transthoracic~     esophagectomy on microcirculatory function. Two hundred patients meeting inclusion criteria~     undergoing planned transthoracic esophagectomy via thoracotomy incision will be prospectively~     enrolled at The University of Virginia. Patients will be followed for 28 days or until~     discharge from the ICU. Evaluation of the sublingual, gastric serosal and mucosal tissues~     will be performed using sidestream dark field (SDF) imaging using the CytoCam® by Braedius~     Medical BV (Huizen, The Netherlands). Scoring of the microcirculation will include an index~     of vascular density (perfused vessel density), an assessment of capillary perfusion~     (proportion of perfused vessels and microcirculatory flow index) and a heterogeneity index.~      Note: the CytoCam® will only take a series of images as consistent with a microscope of~     exposed tissue. Also, the FDA Office of Device Evaluations (ODE) General Surgery Devices~     Branch One - Light Based/laser (GSDB1) has deemed this device to be exempt from 510(K)~     approval.~      http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=5021~      Data from patient's medical charts before and after surgery (30 days post) will be used for~     elucidation of specific complications. We will use the cardiovascular and respiratory~     components of the SOFA score as independent measures of organ dysfunction. Acute kidney~     injury will be defined by the AKIN criteria as an increase of at least 50% above baseline~     serum creatinine and will be graded from stage 1 to 3.~   "
99594|NCT02263651|"~     The objective of this study is to compare quilting suture of the dead space without~     drainage of the pectoral area to conventional closure with drainage to prevent post-operative~     seroma requiring intervention (aspiration or surgical intervention) within 21 days after~     mastectomy for breast cancer.~   "
99595|NCT02263638|"~     Treatment of refractory hemochromatosis rheumatism by Anakinra. Prospective, multicenter,~     non-randomised, single-arm, open-label, phase II trial.~   "
99596|NCT02263625|"~     The aim of the present study is to investigate whether there are differences in indication~     for ventral hernia repair and surgical approach among hernia surgeons from different~     geographical regions of Denmark.~   "
99597|NCT02263612|"~     The Danish Hernia Database (DHD) registers 37 different perioperative parameters. The aim of~     present study is to use large-scale data from DHD to uncover risk factors for long-term (30~     days postoperative and later) readmission, reoperation, death and reoperation for recurrence~     after incisional hernia repair with use of a synthetic mesh.~   "
99598|NCT02263599|"~     The aim of this study is to evaluate on which indication patients are offered operative~     treatment for their ventral hernia, and to investigate the natural course of ventral hernia~     in the population of patients not offered operation.~   "
99599|NCT02263586|"~     Aim of the study is examining the incidence of the occurrence of hyponatremia during a~     Triathlon~   "
99600|NCT02263573|"~     The primary purpose of the protocol is to determine the effects of a new program of PEP'C~     PEP'C with constant load and intermittent recovery (PEP'C-R) on endurance parameters of~     older seniors.~      The study hypothesis: the investigators propose that PEP'C-R training offers a significant~     improvement in endurance parameters for older seniors.~      The secondary objectives are to determine the effects of PEP'C-R on maximal~     cardio-respiratory function, FMD (Flow-mediated dilation), PWV (pulse wave velocity),~     systolic and diastolic heart function, body composition (measured by impedance), biological,~     functional and cognitive functioning and quality of life.~   "
99601|NCT02263560|"~     Many neurological patients express enhanced deficits while walking in a dark room (or during~     the night): the supraspinal structures involved in this navigational deficit have not been~     identified yet. In this project, the investigators will study post-stroke gaits of human~     patients and compare them to those of a control population during a goal-oriented task~     performed in different visual conditions.~      The investigators want to test the hypothesis that during simple goal-oriented locomotor~     tasks, only patients with specific (e.g. medio or infero- temporal) lesions will express~     navigational deficits.~   "
99602|NCT02263547|"~     Primary Objective To determine if colestipol hydrochloride tablets can accelerate the~     elimination of teriflunomide. Teriflunomide will be administered for 14 days followed by~     colestipol dosing of 11 days. Total duration of the study is 40 days.~      Secondary Objectives To collect information on the pattern of side effects with use of~     colestipol hydrochloride after teriflunomide administration and to determine the best~     duration of therapy needed for adequate elimination~   "
99603|NCT02263534|"~     Based on previous studies the single incision minisling is an easy less invasive procedure~     with fewer complications and cure rate similar to conventional midurethral slings in the~     treatment of female stress urinary incontinence. The aim of this study is to test the~     hypothesis that the single incision mini-sling placed in the U position is not inferior to~     TVT in this patient population.~   "
99604|NCT02263521|"~     Development and validation of a measure of physician work motivation.~   "
99605|NCT02263508|"~     Phase 1b Subjects will be treated with talimogene laherparepvec until all injectable tumors~     have disappeared, disease progression per modified Immune-Related Response Criteria (irRC),~     or intolerance of study treatment, up to a maximum of 24 months of study treatment. Subjects~     will be treated with MK-3475 (pembrolizumab) until complete response (CR) disease progression~     per irRC, or intolerance of study treatment, up to a maximum of 24 months of study treatment.~     In Phase 3, Subjects will be treated with talimogene laherparepvec plus pembrolizumab(arm 1)~     or placebo plus pembrolizumab (arm 2) until 24 months from the date of the first dose of~     pembrolizumab or end of treatment due to disappearance of injectable lesions, complete~     response, disease progression per irRC-RECIST or intolerance of study treatment.~   "
99607|NCT02263482|"~     Heart failure is a clinical syndrome that is the common end of several cardiac diseases with~     symptoms such as muscle fatigue, dyspnea and reduction of quality of life. To improve~     respiratory and general functional capacity of these patients, there are strategies that can~     be used such as inspiratory muscle training and peripheral muscle training (dynamic~     resistance training).~   "
99608|NCT02263469|"~     The objective of this study was to assess the safety and efficacy of Replenine®-VF in~     children enrolled in the study, under the age of six years, with severe haemophilia B.~   "
99610|NCT02263443|"~     Our study perform In Department of Gynecology, Faculty of Medicine, Chiang Mai University. In~     our study we divide patients into 3 groups ,First group patients doing Soap suds enema~     (S.S.E.), second group patients doing sodium chloride enema and the last group patient Non~     per os (NPO) before surgery. Our hypothesis is no different about surgical view in 3 groups~     and lower side effects in patients in no bowel preparation group.~      Research objectives~        1. Comparing the surgeon satisfaction ,surgical view and bowel handling in operation of~          soap suds enema group, sodium chloride enema group and the NPO group in patients under~          going exploratory laparotomy in gynecologic surgery.~        2. Comparing the side effects of soap suds enema group, sodium chloride enema group and the~          NPO group.~      Inclusion Criteria~      1. Women under going laparotomy in gynecologic surgery 2. Surgeon consider not too difficult~     surgery. 3. Can understanding Thai language. 4. Can communicate with researcher. 5.~     Consenting participants. Exclusion Criteria~        1. Pregnancy or suspected pregnancy.~        2. Laparoscopic surgery~        3. Do not consent to participate in research~        4. Gastrointestinal infection~        5. Underlying disease such as Intestinal disease, patient who cannot under going bowel~          preparation ,heart disease ,seizure.~        6. Surgeon consider difficult surgery such as fixed mass or uterus with others organs from~          per vaginal examination or very huge mass or history of difficult surgery or history of~          severe adhesion in abdominal cavity.~   "
99611|NCT02263430|"~     Deep Brain Stimulation (DBS) of the Globus pallidus internus(GPi) is useful in the treatment~     of different forms of chorea, including Huntington's disease (HD).~   "
99612|NCT02263417|"~     The purpose of this study was to compare the subthalamic nucleus(STN) with the globus~     pallidus internus(GPi) as a stimulation target for deep brian stimulation(DBS) for medically~     refractory dystonia.~   "
99613|NCT02263404|"~     Anorexia Nervosa (AN) has the highest mortality of any psychiatric disorder and a paucity of~     effective treatments. AN becomes intractable in around 20%, resulting in huge individual and~     healthcare costs. The study will help patients with severe AN using DBS. Individuals with~     severe intractable AN will be eligible to take part in the study.~   "
99614|NCT02263391|"~     This study gathers information about HIV testing utilization and influences on HIV testing~     decisions among young, general population Russian women at-risk of HIV exposure. The study~     compares HIV testing acceptance across two types of low-barrier testing strategies (opt-in~     vs. opt-out) and conducts one of the first randomized experimental comparisons of these~     strategies. The overarching goal is to gain knowledge that can be used to increase~     utilization of HIV testing among at-risk young women and offer gender-specific strategies for~     improving prevention.~   "
99615|NCT02263378|"~     The purpose of this study is to evaluate whether a supplement in which ellagic acid plus~     annona muricata are combined, may modulate the immune response to high risk HPV infection.~     Sixty women will be enrolled in a randomized, controlled study, having a histological~     diagnosis of L-SIL correlated with high rish HPV types infection. Main outcome measure is the~     activation of onco suppressor protein by the supplement and secondary outcome is the~     clearance of HPV infection in the treated group.~   "
99616|NCT02263365|"~     Dehydration post creation of a diverting ileostomy is a common and debilitating problem faced~     by patients undergoing ileal-anal pouch anastomoses for both inflammatory bowel disease and~     familial adenomatous polyposis (FAP) syndrome. Those patients with low rectal cancers or~     other polyposis syndromes e.g. HNPCC hereditary non polyposis colorectal cancers, may~     potentially have a delay in the adjuvant therapy when faced with this complication.~      Studies performed in this groups of patients report a readmission rate of 17-21% for~     dehydration.~      Loperamide has been shown to significantly decrease the daily volume of weight of stool in~     these patients.~      The purpose of this study is to establish whether loperamide given at 4mg three times daily~     for 14 days from day of discharge empirically decreases 30 days readmission rate for~     dehydration.~      The investigators hypothesize that there will be a 15% decrease from 25% to 10% in the~     readmission rates, that severity of dehydration will be decreased.~   "
99617|NCT02263352|"~     This study was performed to assess the efficacy of systemic lycopene (8 mgms Daily for two~     months) as an adjunct to scaling and root planing in chronic periodontitis patients with type~     2 diabetes mellitus.~   "
99618|NCT02263339|"~     The purpose of this study is to learn more about multiple sclerosis (MS). The investigators~     are studying whether aerobic exercise is better than a stretching program at improving brain~     health in people with MS. We want to learn:~        1. If it is safe and practical for people with MS to participate in an aerobic exercise~          program with the goal of increasing cardiac fitness. Cardiac fitness is measured with~          exercise stress tests at the beginning and end of the study.~        2. If aerobic exercise improves brain metabolism, a reflection of brain health, more than~          stretching. Brain metabolism is measured by MRIs at the beginning and end of the study.~      There is a 50% chance of being in the aerobic exercise or the stretching program.~      There are between 8 and 36 visits to OHSU, depending on the intervention group. The total~     duration of the study is at most 21 weeks.~   "
99619|NCT02263326|"~     HIV-1 infected subjects with CD4 nadir > 200 cells/mm3, no history of virologic failure and~     plasma HIV RNA <50 copies/mL for at least 48 weeks while on any United States Department of~     Health and Human Services (DHHS) recommended or alternative three-drug antiretroviral regimen~     will be randomized to dolutegravir (DTG) plus lamivudine (Arm 1) or continuation of their~     current regimen (Arm 2) for 48 weeks. The primary endpoint is virologic failure defined as~     confirmed plasma HIV-1 RNA > 50 copies/mL before or at Week 24~   "
99620|NCT02263313|"~     In this study, the safety and efficacy of COMBO TM stent beyond 36 months are assessed, in~     particular the occurrence of late stent thrombosis and late loss catch-up (restenosis).~   "
99621|NCT02263300|"~     Does spatial orientation of a novice in relation to a mannequin (supine vs upright) impact on~     the development of fiberoptic intubation skills?~      Is it necessary to teach both orientations or is the supine view transferable to the upright~     position?~      Which method demonstrates longer skill retention?~      The hypotheses: Both orientations must be practiced and the upright skill is harder to learn~     but is retained for longer.~   "
99675|NCT02262598|"~     To establish the bioequivalence of fixed dose combination of 40 mg telmisartan / 12.5 mg HCTZ~     vs. its monocomponents~   "
99676|NCT02262585|"~     Study to investigate the bioequivalence of BIBR 277 tablet (Mannitol based) vs. BIBR 277~     capsule~   "
99622|NCT02263287|"~     Dementia with Lewy body (DLB) is the second most common neurodegenerative dementia in autopsy~     series. However, DLB represents a small proportion of the clinical diagnoses in epidemiology~     registries. Indeed Alzheimer disease (AD) and DLB are often concomitant, they share many~     symptoms and only a small weight is given to non-motor symptoms in DLB diagnosis. DLB is at~     the end of a pathological spectrum overlapping with AD, explaining the poor diagnostic value~     of both diagnostic criteria. To date there is still a need for a tool able to discriminate~     patients with pure DLB from those expressing common signs with both AD and DLB and those with~     pure AD. The purpose of this study is to validate a semi quantitative scale designed to~     reflect the Lewy Bodies burden in patients with mild to moderate cognitive decline. The~     investigators hypothesized that the score obtained may differentiate between AD, DLB and~     patients fulfilling clinical criteria for both DLB an AD. This score could also be correlated~     with dopaminergic depletion assessed with [18F]fluorodopa PET/computed tomography and/or with~     potential biomarkers of ADD measured in cerebrospinal fluid. This clinical validation is a~     preliminary work preceding further studies correlating the LeSCoD score with functional~     imaging features, prognosis and therapeutic response. Thus, the expected outcomes involve an~     improvement in demented patients' care, as well as a better patient selection for further~     therapeutic studies~   "
99623|NCT02263274|"~     The primary study objective is to measure the electrical fields evoked by tDCS using subjects~     who have implanted intracranial electrodes as part of their evaluation for epilepsy surgery.~     The measurements obtained in these subjects and their brain MRI will be employed to validate~     existing mathematical models.~      In the future, these refined models can be used to target tDCS to predetermined brain regions~     in healthy and subjects and patient populations. As described above in the safety section,~     the intensities of stimulation applied in this project are not expected to produce changes in~     brain function, are below intensities commonly applied in clinical trials, and fall well~     below safety limits suggested by animal studies.~   "
99624|NCT02263261|"~     Use of a HADM and implant in post-mastectomy breast reconstruction.~   "
99625|NCT02263248|"~     The Investigators are conducting a research study to learn about the safety and benefit of~     using a medication called buprenorphine for patient with difficult to treat depression . This~     research study is testing whether combining two medications will be effective in treating~     depression when initial treatment with just one antidepressant does not relieve the~     depressive symptoms ; this is what is called  difficult to treat depression  or  treatment~     resistant depression . The two medication the investigators are using are  an~     anti-depressant medication called venlafaxine XR ( the generic form of Effexor ) and~     buprenorphine . Buprenorphine is a medication that is FDA approved for the treatment of~     opioid dependence. The investigators are testing whether adding buprenorphine to venlafaxine~     enhances treatment response.~   "
99626|NCT02263235|"~     In France, an estimated 860 000 patients are affected by Alzheimer Disease (AD) which~     represents, as in other developed countries, a major public health issue. In many cases, AD~     diagnosis is uncertain and its clinical evolution unpredictable. The exactitude of the~     diagnosis is however particularly important in the perspective of the validation and use of~     new therapeutic strategies in AD. Detection of cerebrospinal fluid (CSF) diagnosis biomarkers~     fell short in the detection, of atypical/mixed cases, of some differential diagnosis, and in~     differentiating rapid or slow clinical evolutions. Hence, CSF analysis gives a unique~     opportunity to detect and validate biomarkers in many neurological disorders. Nevertheless,~     in medical practice, CSF biological analysis is currently limited to a small number of~     analytes.Quantitative and targeted mass spectrometry, especially operated in the Multiple~     reaction monitoring mode (MRM), represents an alternative to immunodetection and could be~     used to detect specific biomarkers in complex matrices such as plasma by specifically~     discriminating the proteotypic peptides corresponding to each proteins. Mass spectrometry has~     also the ability to distinguish and quantify isotopically labelled and unlabeled selected~     targets. This ability was used in a publication by the group of R. Bateman (Washington~     University, St Louis, USA) who could, after administering stable isotope-labelled leucine,~     evaluate Ab synthesis and clearance in humans. This approach has an enormous potential to~     study the metabolism of proteins within the human CNS and consequently help in the~     understanding and diagnosis of neurological disorders.The main objective of this program is~     set up a targeted quantitative mass spectrometry method for existing and stable~     isotope-labelled CSF biomarkers in the neurological field; exploit this approach for~     diagnostic purpurses and to gain knowledge in the pathophysiology of diseases.~   "
99627|NCT02263222|"~     This is an open-label dose-escalating study to evaluate the tolerability and systemic~     exposure of MDT-10013 in men and women at least 18 years of age who are undergoing primary~     unilateral TKA.~   "
99628|NCT02263209|"~     Prospective clinical investigation to determine the safety of Taperloc stems with BioGuard~     coating and Exceed ABT Taperfit acetabular cups with BioGuard coating when used in cementless~     total hip arthroplasty~   "
99629|NCT02263196|"~     The purpose of this study was to compare the efficacy of combination of alcohol and povidone~     iodine 10% and Alcohol 70% after povidone iodine 10% on inflammation and infection related to~     vascular access area in hemodialysis patients.~   "
99630|NCT02263183|"~     Red palm oil is obtained from crude palm oil through a novel low-temperature process. Owing~     to this special process, RPO possesses a special flavour and aroma, and is rich in~     phytonutrients that include carotenes, vitamin E, phytosterols, phospholipids, squalene,~     phenolic acids, flavonoids and co-enzyme Q10. These phytonutrients are the main constituents~     through which palm oil exhibits its nutritional properties. Among the major health promoting~     properties are anti-cancer, cardio-protection, anti-angiogenesis, cholesterol inhibition,~     brain development and neuro-protective properties, antioxidative defence mechanisms,~     provitamin A activity and anti-diabetes. As red palm oil has variety of phytonutrients and~     health benefits, the potential of improved cardiovascular health should be considered to~     understand better and thus treasure more our golden oil.~   "
99631|NCT02263170|"~     With the project Smart Muscle for Incontinence Treatment (SMIT) a multidisciplinary~     consortium consisting of representatives ranging from clinical medicine via microelectronics~     towards biomaterial science aims to develop a novel implant to treat faecal incontinence. The~     aim of this campaign includes development of implantable prototype devices acting as~     artificial continence muscles using low-voltage electrically activated polymers (EAPs)~     controlled by implemented pressure sensors and the patient.~      Subsequently, the knowledge of the anatomical and biomechanical properties of the anal~     sphincter complex are of cardinal importance. Most of the existing data on anatomy and~     physiology results is based on old studies and almost no data on biomechanical properties are~     available. However, new technologies or even merging data from different examination methods~     might provide new information in this field.~   "
138041|NCT01760434|"~     Evaluate the long-term outcomes following operative and nonoperative treatment of childhood~     scoliosis.~   "
99636|NCT02263105|"~     Currently, the prognosis of recurrent high-grade gliomas is still dismal with no standard~     treatment protocol established. Cisplatin (CDDP), recommended by National Comprehensive~     Cancer Network (NCCN) as a chemotherapeutic agent in salvage treatment for recurrent~     high-grade gliomas, was shown to reduce O6-alkylguanine DNA-alkyl transferase (AGAT) activity~     and potentially capable of enhancing the antitumor effects of temozolomide (TMZ). Compared to~     the standard 5-day TMZ regimen, alternating weekly regimen that deliver more prolonged~     exposure of TMZ may lead to higher cumulative doses, and may deplete more O6-methylguanine~     DNA methyltransferase (MGMT), thus reducing the resistance of tumor cells to TMZ.~      The investigators therefore initiate a single-arm Phase II study to evaluate the efficacy and~     tolerability of CDDP plus alternating weekly TMZ regimen in patients with recurrent~     high-grade gliomas.~   "
99637|NCT02263092|"~     This study aims to understand metaplasticity through the association of transcranial direct~     current stimulation (tDCS) and physical exercise. For this purpose, the study will be~     separate in 2 phases: in the first phase the aim is verify the effects of physical exercise~     on cortical excitability. After this 1st phase two intensities of physical exercise will be~     chosen for the second phase. In the 2nd phase, subjects will undergo to anodal, cathodal and~     sham tDCS plus physical exercise.~   "
99638|NCT02263079|"~     This randomized, controlled, parallel group, open-label multicenter study will evaluate the~     efficacy and safety of a combination of pegylated interferon alfa-2A (Pegasys) plus~     lamivudine or entecavir compared with an untreated control group in participants with HBeAg~     positive CHB in the immune tolerant phase.~   "
99639|NCT02263066|"~     To assess and describe real-life treatment choices for rFⅧ contained regular~     prophylaxis/bleeding prevention treatment in pediatric hemophilia patients in China~     (2007-2013)~   "
99640|NCT02263053|"~     The Temporomandibular Joint (TMJ) is one of the most complex joints in the individual. It is~     composed of the mandibular condyle is positioned within the glenoid fossa of the temporal~     bone, and the articular disk that separates these two bones. The normal biomechanics of the~     TMJ is the concave / convex relationship between the condyles and the articular disc. The~     movements of the TMJ joint are: mandibular depression and elevation (opening and closing of~     the mouth), mandibular protrusion and retraction, and lateral deviations. The DTM is a~     musculoskeletal disorder of the masticatory system that affects over 25% of the population.~     Physical therapy can be adopted this treatment in order to relieve musculoskeletal pain,~     reduce inflammation and restore normal motor functions. The physical therapy interventions~     taken include electrotherapy, exercise therapy, acupuncture and manual therapy. Overall~     objective is to assess the immediate effects of previous mobilization versus flow amplitude~     of mandibular depression in patients with temporomandibular dysfunction. The type of study~     will be a randomized study of two parallel groups balanced distribution (1: 1) and~     double-blind. The research will be conducted in the Laboratory of Human Movement Analysis of~     Physiotherapy, Faculty of Medicine, Federal University of Ceará. The study population will~     consist of residents in the city of Fortaleza-CE individuals who voluntarily seek to~     participate in the study due to symptoms of TMD. Data, anthropometry, application of Research~     Diagnostic Criteria for Temporomandibular Disorders will be collected. The physiotherapist~     responsible for the assessment before and after the interventions will be blind with respect~     to the distribution of the treatment groups. The patient will also be blind, because you will~     not know whether or caudal anterior mobilization was performed. Randomization codes are~     generated by computer using Random Allocation Software (version 1.0.0) at a ratio of 1: 1 by~     a researcher not involved in the data collection. These codes will be placed in sealed,~     opaque envelopes being numbered consecutively, which will ensure the covert allocation of~     study participants. Our data are considered confidential as joint property of the parties~     involved.~   "
99641|NCT02263040|"~     The objective of this pilot study is to assess the immunogenicity and reactogenicity of~     Fluzone High Dose with Fluzone (standard adult dose) influenza vaccines in healthcare~     workers.~   "
99642|NCT02263027|"~     This study will recruit 35 healthcare workers who had systemic reactions to influenza vaccine~     the last 2 times they were vaccinated, to ask whether influenza vaccine is indeed associated~     with systemic reactions in these workers.~   "
99643|NCT02263014|"~     The goal of this research study is to learn more about how different treatment decisions may~     influence the quality of life in women with breast cancer. Researchers want to use what is~     learned from this study to help future patients with breast cancer to be more informed when~     making treatment decisions.~   "
99644|NCT02263001|"~     Musculoskeletal injuries resulting in pain are one of the most common reasons for disability~     and missed duty among military personnel. Additionally, these injuries may create impairment~     in the area of optimal function, sleep and mood that may not be completely resolved with~     currently available therapies. This scenario creates the setting for testing and~     incorporation of additional treatment options to potentially improve care outcomes. Recent~     investigations have examined the adjunctive use of auricular therapy, which utilizes various~     interventions, typically needle-based, to stimulate the ear. This intervention appears to~     modulate the autonomic nervous system to produce more rapid onset of pain relief and~     reduction in pain related co-morbidities. For this trial of adjunctive auricular therapy,~     active duty personnel presenting with an acute or sub-acute musculoskeletal injury triaged to~     outpatient care for treatment will be studied. Subjects randomized to auricular treatment~     will receive, in addition to standard care, up to 12 treatments over a maximum of 3 months~     from a clinician trained in auricular therapy. This trial will specifically examine whether~     the addition of a specific auricular therapy protocol to standard care will have a beneficial~     impact on the pain and functionality of military personnel who sustain an acute or sub-acute~     musculoskeletal injury.~   "
99645|NCT02262988|"~     The purpose of this study is to assess the potential benefit of enhancing total knee~     arthroplasty (TKA) surgery using some of your own cells taken from fat tissue that may be~     able to help recovery and repair of knee tissues.~   "
99646|NCT02262975|"~     This study is an observational study conducted prospectively under routine clinical setting~     for 1 year with about 700 patients diagnosed as Alzheimer's disease who will be treated by~     donepezil (Aricept) as monotherapy. The subjects will be recruited in the selected~     institutions of about 8 countries in Asia.~   "
99677|NCT02262572|"~     Study to assess the comparative pharmacokinetics of telmisartan/HCTZ in two new formulations~     based on sodium salt compared to the present commercial formulation (MicardisPlus®)~   "
99678|NCT02262559|"~     Study to investigate the bioequivalence of BIBR 277 tablet (Erythritol based) vs. BIBR 277~     capsule~   "
99679|NCT02262546|"~     The objective of the study is to assess that pramipexole does not prolong the QT interval~     more than placebo~   "
99680|NCT02262533|"~     The purpose of this study is to assess the effect of Atenolol 100 mg on the Pharmacokinetics~     (PK) of Apixaban and the effect of Apixaban 10 mg on the PK of Atenolol in Healthy subjects.~   "
99681|NCT02262520|"~     The purpose of this study is to assess the effects of Apixaban on the Pharmacokinetics (PK)~     of multiple-dose Digoxin in healthy subjects.~   "
99647|NCT02262962|"~     The purpose of this research is to design and test a new model for delivery of well-child~     care (WCC) for children ages 0-3 years in a sample of low-income parents. The investigators~     used an innovative expert panel and community advisory board process to develop this new~     model for the delivery of WCC to low-income families in partnership with our partner~     community pediatric practices. The new model of care utilizes a trained health educator, or~     Parent Coach at every well-visit from 0-3 years of age. The Parent Coach provides a range~     of services, including health education and guidance, developmental screening, and~     psychosocial screening and services. The Parent Coach works with the Primary Care Physician~     to ensure that the family's needs are met for that well-visit. As a part of this new model~     for well-child care, the parent also uses a web-based tool to help prioritize needs for the~     visit and complete any necessary pre-visit screening. Parents receive additional education~     and guidance from a text message service and have access to the Parent Coach outside of the~     visit.~      The randomized controlled trial (RCT) of this new model of care will include 250 families who~     will be enrolled at participating clinics if the child is under 1 year of age. Parents will~     receive the intervention for 12 months and will complete surveys to collect data on their~     experiences of care. Our hypothesis is that this new model of care will be more~     patient-centered and more effective in providing recommended preventive care services than~     usual care, and that it will be a sustainable and feasible model for the partner practices.~   "
99648|NCT02262949|"~     The purpose of this study is to assess the deliverability, clinical utility, safety and~     effectiveness of the 250 mm length size offering of the LifeStent® Vascular Stent.~   "
99649|NCT02262936|"~     Nocturia, or voiding at night, is an extremely troublesome symptom which is highly prevalent~     in the elderly. Desmopressin is a treatment for nocturia but it can result in hyponatremia~     (low blood sodium), particularly in those aged 65 and older. Fesoterodine is used for the~     treatment of overactive bladder (OAB). Recent trials showed Fesoterodine was effective in~     reducing nocturia. This study aims to answer the following: In women 65 and older with severe~     nocturia, is Fesoterodine more effective than Desmopressin in reducing the number of night~     time voids? Does Fesoterodine have a better side effect profile compared to Desmopressin?~      The study design is a 12 week randomized double-blinded trial of Fesoterodine and~     Desmopressin in the treatment of severe nocturia in women aged 65 and older. This will be~     conducted at the Urogynecology Unit at Mount Sinai Hospital (MSH) and Baycrest. A 3 day~     voiding diary and Nocturia, Nocturnal Enuresis and Sleep-interruption Questionnaire (NNES-Q)~     will be completed at baseline and at week 12. The primary outcome will be the number of night~     time voids in the Fesoterodine group compared to the Desmopressin group, 12 weeks after~     starting treatment. Secondary outcomes include changes in the NNES-Q scores and the safety of~     each medication.~      This study is expected to show that, in women 65 and older with severe nocturia, Fesoterodine~     will be more effective in reducing the number of night time voids, reducing the volume of~     voided urine, increasing the duration of sleep prior to first nocturnal void and improving~     quality of life relative to Desmopressin. Fesoterodine will also be better tolerated, with~     fewer significant adverse events, relative to Desmopressin.~   "
99650|NCT02262923|"~     Metoclopramide is a dopamine D2 receptor antagonist with antiemetic and gastrokinetic~     properties which has been approved for use in pregnant women. Women with polycystic ovary~     syndrome (PCOS) have been found to have lower dopaminergic tone and increased ovarian~     vascularity and vascular endothelial growth factor (VEGF) levels compared to controls. During~     ovarian stimulation, PCOS patients exhibit greater sensitivity to gonadotropins and increased~     follicular development. Administration of dopamine D2 antagonists may mimic the low~     dopaminergic tone noted in PCOS patients, increase VEGF levels, angiogenesis, and~     subsequently improve follicular growth during ovarian stimulation. This strategy could be~     used to improve IVF outcomes in poor responders.~      The investigators hypothesize that, compared to gonadotropin use alone, the use of~     metoclopramide in combination with gonadotropins in poor responders undergoing IVF will~     result in an increased number of mature oocytes obtained at oocyte retrieval and improved IVF~     outcomes.~   "
99651|NCT02262910|"~     The study will be conducted in 2 Stages. The primary objective of Stage 1 of the study is to~     identify the maximum tolerated dose (MTD) of ES414 administered intravenously to patients~     with mCRPC. Secondary objectives are to evaluate the tolerability, pharmacokinetics (PK),~     pharmacodynamics (PD), immunogenicity, cytokine response, and clinical activity of ES414.~      The primary objective of Stage 2 of the study is to evaluate the clinical activity of ES414~     in patients that have or have not received prior chemotherapy. Secondary objectives are to~     further characterize the safety profile, PK, PD, and immunogenicity of ES414.~   "
99652|NCT02262897|"~     Patients with extensive disease(ED) small cell lung cancer is still have a dismal prognosis,~     even though the first line chemotherapy showing about 70% response rate. Most of the patients~     will relapse with in 6 months after the chemotherapy and the following therapy such as second~     line chemotherapy have a very limited efficacy to these patients. Currently, there is no~     standard 3rd line therapy for the patients with ED small cell lung cancer(SCLC).~      As the investigators know, Nab-paclitaxel had showing promising efficacy in several cases~     report in the patients with SCLC, the aim of this clinical trial is to investigate the~     efficacy and safety of nab-paclitaxel as a single agent in the SCLC patients with extensive~     disease and failed to first line/ second line chemotherapy.~   "
99653|NCT02262884|"~     A MULTI-CENTER, PROSPECTIVE, RANDOMIZED, CONTROLLED STUDY TO EVALUATE PHYSICIAN PREFERENCE~     RELATED TO THE USE OF THE SURGIQUEST AIRSEAL INSUFFLATION SYSTEM (AIS) VS. CONVENTIONAL~     INSUFFLATION SYSTEMS (CIS) FOR THE MANAGEMENT OF PNEUMOPERITONEUM DURING ROBOTIC PARTIAL~     NEPHRECTOMY~   "
99686|NCT02262455|"~     This is a Phase I study to test the safety, pharmacokinetics and effectiveness of STM 434~     alone, or in combination with liposomal doxorubicin, in patients with ovarian cancer or other~     advanced solid tumors.~   "
99687|NCT02262442|"~     The aim of this prospective study is to examine the benefits and risks of administration of~     local anaesthetics with a special atomizing set (Enk Fiberoptic Atomizer, Cook Medical)~     during flexible bronchoscopy.~   "
99688|NCT02262429|"~     Newly admitted patients will be screened for risk of malnutrition. Patients will receive~     either the feeding protocol or current oral nutrition supplement (ONS) practice, pending~     location. Patients will continue the nutrition plan taking the supplement post discharge.~     Study team will follow-up with telephone calls to help support post-discharge ONS compliance.~     Quality and service utilization data will be gathered for analysis.~   "
99654|NCT02262871|"~     Many patients with cystic fibrosis (CF) require hospitalization and/or Intensive Care Unit~     (ICU) admission because of acute exacerbation of chronic respiratory failure or for any acute~     deterioration of clinical status. Non-invasive ventilation (NIV) is the first option for the~     clinical management of CF patients with moderate-to-severe respiratory distress and NIV has~     been shown to improve gas exchange, reduce respiratory muscle work and improve pulmonary~     function in patients with obstructive lung disease in general and those with acute CF~     exacerbation. High-flow nasal oxygen cannula (HFN) is a relatively new system providing~     heated and humidified, high-flow (50L/min) oxygen through the nostrils. This device provides~     a small positive pressure, probably washes-out the pharyngeal dead space, reduces inspiratory~     resistance, and possibly facilitates secretion clearance. The technique is very well~     tolerated. From a physiologic standpoint, this device could help CF patients by improving gas~     exchange, reducing respiratory workload, and facilitating mucus clearance. Non-interrupted~     delivery may be possible given better clinical tolerance in contrast with bi-level positive~     pressure NIV. Whether the short-term physiological efficacy of HFN is comparable to NIV is~     unknown and there is no study on the benefit of HFN in CF patients.~      The aim of this study is to compare the physiological effects of HFN and NIV in CF patients~     requiring ventilatory support. Our hypothesis is that HFN will not be inferior to NIV, as~     evaluated by breathing pattern, gas exchange, and respiratory workload and will decrease dead~     space. In addition, comfort and preference between the two techniques will be evaluated.~   "
99655|NCT02262858|"~     Study to investigate the bioequivalence of 80 mg telmisartan/12.5 mg hydrochlorothiazide~     (HCTZ) fixed dose combination compared with its monocomponents~   "
99656|NCT02262845|"~     The purpose of this study is to document clinical utility and distribution of indications for~     short term pancreatic stenting, and stent type preference by indication at tertiary referral~     centers with expertise in pancreatic endotherapy.~   "
99657|NCT02262832|"~     Background:~      - Generalized lipodystrophy can cause high blood fat levels and resistance to insulin. This~     can lead to health problems including diabetes. Researchers have found that the drug~     metreleptin improves health in people with this disease.~      Objective:~      - To test the safety and effectiveness of metreleptin.~      Eligibility:~        -  People ages 6 months and older with generalized lipodystrophy who:~        -  have received metreleptin through NIH studies AND~        -  cannot get it through approved or compassionate use mechanisms in their home country.~      Design:~        -  Participants will come to NIH approximately every 6 months during year one, then every 1~          2 years. Financial assistance may be available for travel within the U.S.~        -  At visits, participants will get a supply of metreleptin to take home for daily~          injections. They will have:~        -  plastic catheter placed in an arm vein.~        -  blood tests, urine collection, and physical exam.~        -  oral glucose tolerance test, drinking a sweet liquid.~        -  ultrasound of the heart, liver, uterus, and ovaries. A gel and a probe are placed on the~          skin and pictures are taken of the organs.~        -  echocardiogram, which takes pictures of the heart with sound waves.~        -  Resting Metabolic Rate taken. A plastic hood is worn over the head while the oxygen they~          breathe is measured.~        -  Participants will have up to 3 DEXA scan x-rays per year.~        -  Participants may have:~        -  annual bone x-rays.~        -  liver biopsies every few years. A needle will be inserted into the liver to obtain a~          small piece. Participants will sign a separate consent for this.~        -  Participants must be seen regularly by their local doctors and have blood tests at least~          every 3 6 months at home.~   "
99658|NCT02262819|"~     Background:~      - Staphylococcus aureus, or staph, is commonly found on the skin and in the respiratory~     system. Sometimes people who get sick with staph infection do not get better with standard~     treatment. These staph infections can be serious and even deadly. Researchers want to find~     out why some people are more likely to get the infection.~      Objectives:~      - To look at the immune response of the skin when it is exposed to bacteria.~      Eligibility:~        -  People age 2 65 with hyper IgE syndrome (HIES) and those with recurrent staph~          infections.~        -  Healthy volunteers.~      Design:~        -  Participants will be screened with medical history, physical exam, and blood tests.~        -  Over 1 5 days, participants may have blood tests and a skin and nasal swab. They may~          have additional tests if needed. If they had a recent biopsy, researchers may ask for a~          sample from it.~        -  Some participants will spend the night at the clinic. Their vital signs will be taken~          and they will have blood drawn. Some participants will take aspirin or ibuprofen~          starting 2 days before their stay.~        -  Some participants will have blisters created on the inside of their forearm. Suction~          will pull a layer of skin from their arm. Skin will be removed. Different solutions will~          be applied to the blisters. Up to 3 biopsies may be taken.~        -  Children will not have blood tests or biopsies.~        -  Participants will be called every day for 10 days, then at 30 days after the procedure.~        -  Participants will have a follow-up visit 10 days after the procedure.~        -  Participants who did not get blisters or biopsies will not have any follow-up~          appointments.~   "
99682|NCT02262507|"~     Significant morbidity, mortality, and related costs are caused by traumatic brain injury~     (TBI). A simple, effective, and lightweight device worn by athletes or war fighters in the~     field, designed to mitigate TBI resulting from blast trauma or concussive events, would save~     lives, and the huge costs currently being experienced for life-treatment of surviving~     victims. An externally-worn medical device that applies mild jugular compression according to~     the principle of the Queckenstedt Maneuver (the Device) is being developed by Q30 Labs, LLC~     (Q30). Initial research suggests that the Device has the potential to reduce the likelihood~     of TBI. The rationale for testing wideband absorbance and Oto-acoustics emissions (OAE) is~     that the investigators need a physiologic, non-invasive method to evaluate the brain~     responses to mild jugular compression across multiple age groups. To determine this with MR~     imaging is currently cost prohibitive. The investigators pilot data from the parent IRB~     indicates a consistent response measured via wideband absorbance in young adults. Therefore,~     a preliminary step to evaluate the safety and efficacy of the neck collar device is to employ~     this technology across a wide range of ages.~   "
99683|NCT02262494|"~     The main objective of our study is to determine the diagnostic performance of an~     ultra-portable ultrasound (V-Scan®) device for emergency compression ultrasound when used by~     experienced ermergency doctors searching for proximal deep vein thrombosis (DVT) in patients~     with no history of DVT. The gold standard is Doppler ultrasound of the lower limbs performed~     by a vascular exploration expert.~   "
99659|NCT02262806|"~     Background:~      - Partial lipodystrophy can cause high blood fat levels and resistance to insulin. This can~     lead to health problems including diabetes. Researchers have found that the drug metreleptin~     improves health in people with this disease.~      Objective:~      - To test the safety and effectiveness of metreleptin.~      Eligibility:~        -  People age 6 months and older with partial lipodystrophy who~        -  have received metreleptin through NIH studies and shown improvement AND~        -  cannot get metreleptin other ways.~      Design:~        -  Participants will come to NIH approximately every 6 months during year one, then every 1~          2 years. Financial assistance may be available for travel within the U.S.~        -  At visits, participants will get a supply of metreleptin to take home for daily~          injections, or it can be shipped to them inside the U.S. They will have:~        -  plastic catheter placed in an arm vein.~        -  blood tests, urine collection, and physical exam.~        -  oral glucose tolerance test, drinking a sweet liquid.~        -  ultrasound of the heart, liver, uterus, and ovaries. A gel and a probe are placed on the~          skin and pictures are taken of the organs.~        -  echocardiogram, which takes pictures of the heart with sound waves.~        -  Resting Metabolic Rate taken. A plastic hood is worn over the head while the oxygen they~          breathe is measured.~        -  Participants will have up to 3 DEXA scan x-rays per year.~        -  Participants may have:~        -  annual bone x-rays.~        -  liver biopsies every few years. A needle will be inserted into the liver to obtain a~          small piece. Participants will sign a separate consent for this.~        -  Participants must be seen regularly by their local doctors and have blood tests at least~          every 3-6 months at home.~   "
99660|NCT02262793|"~     To investigate the relative bioavailability of telmisartan respectively of dipyridamole after~     concomitant administration of 80 mg telmisartan in Micardis® and 25 mg acetylsalicylic acid~     (ASA)/200 mg extended release (ER) dipyridamole (DP) in Aggrenox® (Test 1) relative to ER-DP~     in Aggrenox® alone (Reference 1), respectively relative to telmisartan in Micardis® alone~     (Reference 2).~      To investigate the relative bioavailability of dipyridamole respectively of telmisartan~     administered as 25 mg ASA/200 mg ER-DP 30 minutes after intake of 80 mg telmisartan (Test 2)~     relative to dipyridamole in Aggrenox® alone (Reference 1), respectively relative to~     telmisartan in Micardis® alone (Reference 2).~   "
99661|NCT02262780|"~     Group 1:~      To investigate safety, tolerability and pharmacokinetics of Telmisartan + HCTZ (T40/H12.5 and~     T80/H12.5)~      Group 2:~      To investigate safety, tolerability and pharmacokinetics of Telmisartan + HCTZ (T80/H12.5 x 7~     days)~   "
99662|NCT02262767|"~     This study will test the hypothesis that PF-06649751 with continuous co-administration of~     trimethobenzamide hydrochloride (TMB) with will be safe and well tolerated. Single doses of~     PF-06649751 will be tested in this study, starting at a low dose and escalating to a dose~     projected to be under the current limits for drug concentration.~   "
99663|NCT02262754|"~     PF-06372865 In Subjects With Chronic Low Back Pain~   "
99664|NCT02262741|"~     This is a multicenter, open-label, dose-exploration and dose-expansion study to evaluate the~     safety, tolerability, antitumor activity, PK, pharmacodynamics, and immunogenicity of~     MEDI4736 in combination with tremelimumab in subjects with recurrent/metastatic squamous cell~     carcinoma of the head and neck.~   "
99665|NCT02262728|"~     The purpose of this study is to assess the efficacy of a 12-week regimen containing~     simeprevir, daclatasvir and sofosbuvir in participants with decompensated liver disease (the~     liver function is insufficient) due to genotype 1 or 4 Hepatitis (inflammation of the liver)~     C virus (HCV) infection by assessing sustained virologic response 12-weeks after the end of~     study drug treatment (SVR12).~   "
99666|NCT02262715|"~     The purpose of this study is to investigate the drug-drug interaction between VX-787 and~     oseltamivir, when co-administered at steady-state in healthy participants. In addition the~     safety, tolerability and pharmacokinetics (the study of the way a drug enters and leaves the~     blood and tissues over time) of VX-787 will be assessed.~   "
99667|NCT02262702|"~     The aim of this observational study is to compare the use of an extended release paracetamol~     formulation with standard paracetamol in a cohort of Australian concessional patients with~     osteoarthritis (OA), to assess differences in prescribing patterns and patient compliance.~   "
99668|NCT02262689|"~     The study evaluates the effect of GSK2256294 exposure at steady state on pulmonary artery~     systolic pressure (PASP) in healthy volunteers, under hypoxic conditions, after 7 days of~     dosing. It is single centre, double blind, randomized, placebo-controlled study to be~     conducted in approximately 30 healthy volunteers. Subjects will be screened no more than 30~     days. Subject will be admitted in clinical unit on Day -1. Subject will be dosed for 7 days~     in unit in morning on all days except for dosing on Days 3 -6. Dosing on Days 3 -6 will occur~     at home. Subjects will return to the unit on the evening of Day 6 and remain there until Day~     8. Subjects will undergo echocardiography under normoxic and hypoxic on Day 1 pre-dose and on~     Day 7 post-dose. Subject will be followed up for 28- 32 days after discharge. The maximum~     estimated time that a subject will be enrolled in the study is 62 days from the screening~     visit to follow up.~   "
99669|NCT02262676|"~     Depict demographic and clinical features of patients with atrial fibrillation treated with~     rivaroxaban to prevent stroke and pulmonary embolism in routine clinical practice~   "
99670|NCT02262663|"~     This is a study in healthy women of reproductive age to investigate the pharmacodynamics~     (mainly ovarian activity), pharmacokinetics and safety of vilaprisan after daily oral~     administration of 4 different doses over 84 days, using a randomized, parallel-group,~     multicenter design.~   "
99671|NCT02262650|"~     Study to investigate the relative bioavailability of concomitant administration of~     clopidogrel and telmisartan (Test 1) relative to the bioavailability of SR26334 alone~     (Reference 1), and relative to the bioavailability of telmisartan alone (Reference 2). And to~     investigate the bioavailability of SR26334 following administration of clopidogrel 30 minutes~     after intake of telmisartan (Test 2) relative to the bioavailability of SR26334 alone~     (Reference 1), and relative to the bioavailability of telmisartan alone (Reference 2)~   "
99672|NCT02262637|"~     Study to evaluate efficacy and tolerability of Micardis®/MicardisPlus® under usual~     daily-practice prescribing-conditions with emphasis on effects on endorgan damage in the~     clientele of cardiologists, nephrologists, and diabetologists~   "
99673|NCT02262624|"~     To establish the bioequivalence of 80 mg telmisartan/12.5 mg HCTZ fixed dose combination vs.~     its monocomponents~   "
99689|NCT02262416|"~     In-Vitro Fertilisation (IVF) is the term commonly applied to a form of treatment for~     infertility that involves controlled ovarian hyperstimulation, egg maturation, egg~     collection, fertilisation, embryo culture and finally embryo transfer. The period after egg~     collection is called luteal phase. In Australia, vaginal progesterone is routinely used to~     support the lining of the uterus so that it is susceptible to implantation of the embryos.~      More recently, there has been some suggestion that additional supplementation of luteal phase~     with GnRH agonist increases clinical pregnancy and live birth rate. These studies are however~     heterogeneous and results were inconsistent.~      This study is a prospective randomised controlled trial of additional GnRH agonist in luteal~     phase of antagonist cycle. The primary hypothesis is that GnRH agonist increases the number~     of live birth . The secondary hypothesis is that this increases the clinical pregnancy rate,~     on-going pregnancy rate, without affecting the miscarriage rate, ovarian hyperstimulation~     rate and multiple pregnancy rate.~   "
99690|NCT02262403|"~     The main objective of this study is to characterize the regulatory immune response induced by~     hookworm in an infected Vietnamese rural population from the periphery of HCM, evolution~     after infection treatment and during potential naturally reinfection.~   "
99691|NCT02262390|"~     2.1 Primary Study Hypothesis In sub-Saharan Africa, between 2.5-17% of pregnant women are~     infected with syphilis [1]. It is estimated that 53-82% of women with untreated syphilis had~     adverse outcomes compared to only 10-21% of uninfected women[2]. The investigators and others~     have shown that syphilis screening integrated into an HIV antenatal clinic with prevention of~     mother to child transmission (PMTCT) is highly accepted with excellent uptake. Unfortunately,~     the minority of male partners come in for testing and treatment (1%-27%) which has important~     implications for the roll-out of rapid syphilis testing and the inability to detect~     reinfection with treponemal antibody test as the test will remain positive despite treatment.~     The investigators hypothesize that sending an SMS reminder or a telephone call reminder by a~     health care worker will be more effective than a standard notification slip given to women to~     bring male partners to antennal clinic for testing and treatment.~   "
99692|NCT02262377|"~     The purpose of this study is to determine whether Integrative Medicine Group Visits (IMGV)~     are effective for treating patients with chronic pain and depression.~   "
99693|NCT02262364|"~     The primary objective of this study is to assess the safety of a single injection of APS.~   "
99694|NCT02262351|"~     Atrial fibrillation (AF) is a major risk factor for stroke. The identification and treatment~     of AF is one of the best way to prevent stroke. The problem is that because AF may cause~     minimal symptoms, it often goes undetected before a patient suffers a stroke. Also, it is~     known that as many as half of all patients with known AF may not be receiving appropriate~     anticoagulation for their condition. New technologies are making it possible to improve AF~     detection. Subjects in this study will be screened for AF using three simple methods: a~     30-second pulse check, a hand-held single-lead electrocardiogram (ECG) device and a blood~     pressure monitor with built-in AF screening capabilities. If more patients with AF can be~     detected, more patients will be able to receive guideline-recommended anticoagulant therapy,~     and more strokes, deaths, disability, and dementia will be prevented.~   "
99695|NCT02262338|"~     AGT-182 is a fusion protein containing idursulfase that is intended to deliver the enzyme~     peripherally and to the brain, when administered intravenously. This study is a safety and~     dose ranging study to obtain safety and exposure data, as well as information on the~     biological activity of the investigational drug.~   "
99696|NCT02262325|"~     This phase II trial studies how well giving a hypofractionated boost to the primary tumor~     before standard chemotherapy and radiation therapy works in treating patients with stage II~     or III non-small cell lung cancer that cannot be removed by surgery. Advances in radiation~     oncology have allowed better radiation targeting which may be able to send x-rays directly to~     the tumor and cause less damage to normal tissue. Drugs used in chemotherapy, such as~     cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by~     killing the cells, by stopping them from dividing, or by stopping them from spreading.~     Radiation therapy uses high energy x-rays to kill tumor cells. Giving more precise and~     targeted radiation before standard chemotherapy and radiation therapy may kill more tumor~     cells and prevent the cancer from coming back in the location in which it started.~   "
99697|NCT02262312|"~     Patients with myelodysplastic syndrome (MDS) have an ineffective hemopoiesis and often suffer~     from anemia. This can lead to red blood cell transfusion dependency and iron overload. Iron~     overload can affect the liver and lead to liver fibrosis and worst case cirrhosis. Ferritin~     is usually used to monitor the iron overload. In this study MDS patients will have a~     transient elastography performed which measures the liver's stiffness. The purpose is to~     investigate whether liver stiffness measurements are coherent to ferritin levels.~   "
99698|NCT02262299|"~     A European multi-centre, randomised, double-blind placebo-controlled trial of Pirfenidone in~     bronchiolitis-obliterans-syndrome grade 1-2 in lung transplant recipients.~      Randomized double blinded, placebo controlled study. Eligible patients are to be randomized~     in a 1:1 ratio to receive either Pirfenidone 2403 mg/d or the matching placebo treatment for~     6 months.~      Primary objective To evaluate the effect of Pirfenidone on the change in FEV1 in liters over~     6 months in lung transplant recipients with bronchiolitis obliterans syndrome.~   "
99699|NCT02262286|"~     Procure blood specimens from individuals presenting to the emergency department with~     suspected brain injury.~   "
99700|NCT02262273|"~     This study will be carried out as a retrospective, non-interventional observational review of~     medical records for patients in multiple countries with platinum-sensitive recurrent serous~     ovarian cancer. The objectives are to describe in a real-world population, treatment~     patterns, BRCA mutation testing and results, overall survival, health care utilization and~     also to estimate rates of selected treatment- and/or disease-related side effects~   "
99701|NCT02262260|"~     To explore a more clinical feasible treatment regime with ranibizumab for DME to provide~     satisfactory treatment effect with a lower number of visits and injections.~   "
99702|NCT02262247|"~     The objectives of this study are to evaluate the performance of the Medrobotics Flex® Robotic~     System to visualize and access specific anatomical locations along with evaluation of the~     safety of the device.~   "
105759|NCT02183090|"~     Study to investigate the pharmacokinetics and tolerability of an intramuscular 15 mg~     meloxicam injection in comparison to the 15 mg oral tablet~   "
99703|NCT02262234|"~     Chronic pain (pain that is that is present for a long period of time) is very common among~     people with spinal cord injury (SCI). Unfortunately, chronic pain is very difficult to treat.~     Many treatments reduce chronic pain only partially. As a result, many people with SCI must~     find ways of accomplishing daily activities even though they have pain.~      The purpose of this research study is to determine how well two different kinds of education~     programs reduce the extent to which chronic pain interferes with daily life and well-being.~   "
99704|NCT02262221|"~     Randomized, multicenter trial to evaluate the cost-effectiveness of 2 different follows up~     programs in head and neck cancer survivors. Patients in complete remission at month 6 (+/- 1~     month) after curative treatment will be randomized in two arms according to 2 different~     follow up approaches: Non Intensive Follow up approach (Arm A) with no radiologic~     evaltuations scheduled, but required only at the occurence of any signs or symptoms and~     Intensive Follow up approach (Arm B) with scheduled radiologic evaluations.~   "
99705|NCT02262208|"~     The aim this study is characterize glycemic variability using linear and nonlinear~     mathematical tools, under basal conditions and in response to specific protocols acute~     exercise that evoke oxidative stress and inflammation in healthy subjects and type 2 diabetes~     patients. For this purpose, the sample size will consist of 37 individuals healthy and 32~     without type 2 diabetes mellitus wore a CGMS during 3 days. Participants randomly performed~     aerobic and eccentric sessions, both in the morning (24h after CGMS placement), and at least~     7 days apart. Glucose variability was evaluated by glucose standard deviation, glucose~     variance, mean amplitude of glycemic excursions (MAGE), and glucose coefficient of variation~     (conventional methods) as well as by spectral and symbolic analysis (non-conventional~     methods). Physiological mechanisms altered by exercise protocols (Human Soluble Interleukin-6~     and Glutathione), will be measured in blood samples.~   "
99706|NCT02262195|"~     The purpose of the study is to determine if a new pulse oximeter accurately detects~     carboxyhemoglobin and methemoglobin when intentionally increased in the blood.~   "
99707|NCT02262182|"~     Pulmonary atelectasis is a frequent respiratory postoperative complication in cardiac~     surgery. Classically, the treatment of these patients is based on manual chest physiotherapy.~     Our objective is to evaluate the interest of association of positive end expiratory delivery~     sessions with the EzPAP® device. We perform a prospective monocentric, open label trial.~     Patients with atelectasis after scheduled cardiac surgery with cardiopulmonary bypass are~     included. They benefit from manual chest therapy and are randomised to receive or not~     positive end expiratory pressure sessions twice a day. The primary endpoint is the effect of~     this treatment on atelectasis radiological score after 2 days of treatment. The secondary~     endpoints are: oxygen saturation(SpO2)/inspired oxygen(FiO2) ratio, qualitative evaluation of~     ventilatory function, respiratory & cardiac rate, pain, inspiratory pressure (sniff test),~     patient satisfaction, duration of intensive care unit (ICU) and hospital stay.~   "
99708|NCT02262169|"~     This is a 2-arm, prospective, double-blind, double-dummy, randomized-controlled study using~     DLBS2411 at a dose of 250 mg twice daily (before morning and evening meals), or omeprazole at~     a dose of 40 mg once daily (before morning meal), for an 8-week course of therapy, for the~     treatment of patients with any non-bleeding peptic ulcers.~      DLBS2411 is a bioactive fraction of an Indonesian native herbal, Cinnamomum burmanii, locally~     known as kayu manis have been proven at cellular and genetic levels to have an antiulcer~     effect through both suppressing the gastric acidity and enhancing gastric mucosal protection.~     The anti-secretory effect of DLBS2411 is exerted through the inhibition of H+/K+ ATPase~     'pump' as well as down-regulation of the H+/K+ ATPase gene expression, thus suppressing~     gastric acid secretion; while its gastro-protective defense mechanism works through the~     promotion of COX-2 derived prostaglandin (PgE2) synthesis, stimulating gastric-epithelial~     mucous and bicarbonate secretion; anti-oxidative activity; and endothelial-nitric oxide (NO)~     formation.~      Recent study of DLBS2411 in healthy volunteers demonstrated the effective role and safety of~     DLBS2411 in suppressing intragastric acidity. Having such mechanisms of action, DLBS2411 is~     hypothesized to benefit in peptic ulcers.~   "
99709|NCT02262156|"~     The aim of the study is to compare the effect of group-cognitive-behavioral therapy~     (CBT)versus treatment as usual with the selective serotonin reuptake inhibitor sertraline, in~     patients with diagnosis of temporal lobe epilepsy (TLE) and depressive disorder.~   "
99710|NCT02262143|"~     Efficacy and safety of combination therapy of rosuvastatin and fenofibrate versus~     rosuvastatin monotherapy in mixed dyslipidemia patients: A randomized, multi-center,~     double-blind, phase 3 study~   "
99711|NCT02262130|"~     Solar urticaria is a rare disease, with a usual favourable outcome with photoprotection and~     with anti H1 histamines. Nevertheless, some cases can be severe and refractory to this usual~     treatment, leading to a large impact on quality of life. New treatment options are warranted.~     The investigators aim to test the efficacy and the safety of omalizumab, an anti-IgE antibody~     recently approved in chronic spontaneous urticaria, in this setting.~   "
99712|NCT02262117|"~     A prospective, randomized, controlled, open two-arm study to evaluate the interest of the~     pre-conceptional endometrial immune profiling to increase birth rates.~   "
99713|NCT02262104|"~     The purpose of this study is to investigate the effect of an exercise program on nursing home~     patients with dementia.~   "
99714|NCT02262091|"~     The aim of this research is to assess the immune enhancing property of food fibers in the~     elderly population.~   "
99715|NCT02262078|"~     Heart failure with preserved ejection fraction (HFpEF) is a major public health problem that~     has no proven effective treatment. This study will assess the effects of nebulized inhaled~     nitrite administration on resting and exercise hemodynamics in patients with HFpEF referred~     to the catheterization lab.~   "
99716|NCT02262065|"~     Assessment of cytokine polymorphisms in 100 patients with aseptic complications to~     arthroplasty as compared to 100 symptom-free arthroplasty patients.~      In selected patients additional in-vitro cytokine release assay with peripheral blood~     mononuclear cells (PBMC) stimulated with different wear particles.~   "
99755|NCT02261558|"~     This study will investigate the impact of music therapy on newly diagnosed patients with~     cancer undergoing chemotherapy. Measurements used at baseline, middle and end of first cycle~     will be the Resiliency Scale (Wagnild and Young 1993); The HADS scale (hospital anxiety~     depression scale, Zigmond and Snaith 1983 )and and The CAS scale for pain (Color Analysis~     Scale).~   "
99717|NCT02262052|"~     The Theia-study is a prospective, multicenter, single-arm management (cohort) study.~      Consecutive patients with clinically suspected acute, recurrent, ipsilateral, proximal deep~     vein thrombosis (DVT), who fulfil all the inclusion criteria and meet none of the exclusion~     criteria, are eligible for inclusion and will be managed according to the result of a~     magnetic resonance direct thrombus imaging (MRDTI) of the affected leg. The MRDTI is to be~     performed and adjudicated within 24 hours of study inclusion. The final treatment decision~     will be made based on this ruling of the MRDTI. In case of a positive MRDTI signal, patients~     will be treated with therapeutically dosed anticoagulants. Patients with a negative MRDTI~     ruling will be subjected to a standardized compression ultrasonography (CUS) within 48 hours~     after initial presentation. The latter CUS serves as a reference test in case the patient~     returns with symptoms of ipsilateral recurrence in the future, and will not be used for~     management decisions at baseline. The study flowchart can be found in Appendix A.~      All patients will be followed for three months for the occurrence of acute recurrent venous~     thrombo-embolism (VTE). In case of suspected recurrent VTE, objective testing including~     either computed tomography pulmonary angiography (CTPA) for PE or CUS for DVT will be~     performed. Additionally, in case of a proven ipsilateral recurrent DVT during follow-up,~     MRDTI will be repeated.~   "
99718|NCT02262039|"~     The purpose of this study is to determine if the Airseal System will reduce post-operative~     pain and reduce the need for narcotics in laparoscopic living kidney donor surgeries.~   "
99719|NCT02262026|"~     Functional neuroimaging of alcoholism vulnerability: glutamate, reward, impulsivity, and~     Pavlovian-to-instrumental transfer (PIT), part II Saracatinib~   "
99720|NCT02262013|"~     Investigators propose to pilot an adolescent obesity intervention, TEENS+, to examine the~     feasibility of this dietary intervention strategy and preliminary effectiveness of two models~     of parental involvement within adolescent obesity treatment.~   "
99721|NCT02262000|"~     This study will help researchers learn about the best dose of radiation to be used when~     treating large early stage non-small cell lung cancer (NSCLC) with a treatment called~     stereotactic ablative radiotherapy (SABR). Current treatments with SABR for early stage NSCLC~     show positive response. But, for large early stage NSCLC it may be better to give different~     SABR doses than what is used in routine early stage NSCLC treatment. It is not understood~     which dose is best for treating large early stage NSCLC. Therefore, this study can help~     researchers learn if giving a higher dose using SABR over a period of 5-10 treatment days can~     increase the chance of cure for large early stage NSCLC.~   "
99722|NCT02261987|"~     This trial aims to analyze whether the resistive inspiratory manoeuvre (RIM) performed~     previously to autogenic drainage (AD) technique improves the effectiveness in terms of mucus~     clearance during a typical bronchial drainage session in adults, stable CF patients.~   "
99723|NCT02261974|"~     Outside United States (OUS) Post-Market Parallel Group Exploratory Study Design~      The objective of this study is to determine the safety and effectiveness of the Viveve System~     to treat the vaginal introitus in women following vaginal birth(s) and in so doing improving~     vaginal laxity.~   "
99724|NCT02261961|"~     The loss of muscle mass and strength due to aging leads to serious health problems for older~     adults. Muscle health can be improved by exercise training, but some people improve their~     strength substantially, whereas others improve little. The reason for this variation is~     unknown. This study will investigate whether function of the immune system influences how~     well people respond to exercise. Older Veterans who participate will have their muscle size,~     strength, and function measured periodically for almost a year. Participants will drink a~     nutritional supplement or placebo daily and complete a 36 session strength training program.~     Participants will be vaccinated for tetanus and donate small amounts of blood and muscle~     tissue during the study so that immune function can be compared to muscle outcomes during~     training and during a long-term follow-up. The study results should increase the~     investigators' understanding of the negative effects of aging on muscle and will possibly~     lead to better strategies for muscle maintenance and rehabilitation for older adults.~   "
99725|NCT02261948|"~     The present study was conceived to evaluate the effects of levosimendan on cardiopulmonary~     exercise test (CPET) and DLCO ( Diffusion capacity of Lung for carbon monoxide) in patients~     with severe heart failure in stable clinical conditions (NYHA - New York Heart Association -~     class III, with a peak VO2 (Oxygen consumption ) < 12 ml/min/kg) on top of optimized standard~     therapy.~   "
99726|NCT02261935|"~     In this project the investigators will train home care nurses to use the Carer Support Needs~     Assessment Tool (CSNAT) with a group of family caregivers (intervention group) and then~     compare the family caregivers' quality of life, burden and other outcomes to a group of~     family caregivers whose home care nurse is not using the CSNAT (control group). Findings will~     allow us to determine the effectiveness of using the CSNAT as a tool to identify, monitor and~     address family caregiver support needs in palliative home care.~   "
99727|NCT02261922|"~     To evaluate the effect of ticagrelor on endothelial function as measured by flow mediated~     dilation of the brachial artery. This will be compared to prasugrel.~   "
99728|NCT02261909|"~     NephroCheck is measuring the concentration of a certain protein combination in the urine of~     patients. In elevated values there is a probability of renal failure (already proven in~     intensive care patients). The investigators would like to investigate whether the~     investigators can predict renal failure in patients receiving contrast enhanced CT's in the~     emergency department. That would lead to an earlier nephrologist consult in those patients.~   "
99729|NCT02261896|"~     The purpose of this study is to determine whether the use of antibiotic prophylaxis is~     appropriate when performing a pancreatic cyst fine needle aspiration guided by endoscopic~     ultrasonography.~   "
99730|NCT02261883|"~     This pilot study aims to assess the safety and treatment effect of acute dosing with IV~     Remodulin in neonates with persistent pulmonary hypertension of the newborn (PPHN).~   "
99756|NCT02261545|"~     The aim of this study is to determine the effects of supplementation with n-3 fatty acid or~     placebo for 10 weeks on the expression of Sirt-1, AdipoR1 & AdipoR2 genes in the peripheral~     blood mononuclear cell (PBMC) and circulatory levels of Resistin, MCP-1 and Adiponectin of~     type2 diabetes patient~   "
99757|NCT02261532|"~     The primary objective of this study is to evaluate the pharmacokinetics of TAS-102 after~     single and multiple dose in Chinese patients with solid tumor.~   "
99731|NCT02261870|"~     The investigators propose a simple and non-invasive method to monitor heart transplant~     patients with MRI. Its diagnostic and prognostic values have already been assessed in two~     monocentric studies. Other monocentric studies based on related methods have confirmed the~     investigators findings. These studies are insufficient to allow a large diffusion of the~     technique. Only a large multi-centric study will change medical practices. In addition, this~     project will spread the new method at a national level and will allow an assessment of its~     practical usefulness in centres not familiar with MRI T2 quantification.~      Furthermore, MRI seems to detect rejections at earlier stage than biopsy. A confirmation of~     this observation could lead to a modification of diagnostic criteria of cardiac graft~     rejection. The ultimate aim of the DRAGET project is to replace a strategy based solely on~     biopsy with one based on a first-line MRI (with biopsy only when needed) for a more efficient~     and earlier detection of rejection. This would constitute a major advance in patients~     security and comfort as well as an economic improvement.~   "
99732|NCT02261857|"~     The purpose of this study is to determine whether patient-specific computer-aided design~     (CAD) and three-dimensional (3D) printing can be utilized to produce personalized, effective~     continuous positive airway pressure (CPAP) masks for children with severe obstructive sleep~     apnea (OSA) and craniofacial anomalies who encounter significant difficulty using CPAP~     because of poorly fitting masks despite exhausting available commercial mask options.~   "
99733|NCT02261844|"~     The purpose of this study is to determine if Resveratrol, a nutritional supplement, shows a~     beneficial effect in the cellular function of normal liver cells and diseased liver cells~     (cancer cells) in samples of liver tissue taken during elective liver surgery. Outcomes based~     on 3 measures will test the hypothesis that Resveratrol when used as a nutritional supplement~     will 1)improve metabolic function in liver cells, 2)reduce cellular growth and proliferation~     of cancer cells, 3)decrease inflammation in the liver.~   "
99734|NCT02261831|"~     The investigators will compare 16sRDNA profile in cases and controls in order to identify~     bacteria associated with metabolic diseases that reside both in intestinal crypts and in~     blood.~   "
99735|NCT02261818|"~     Can peer mentors be integrated into depression care to older adults with mental health~     professional supervision? We will assess whether peer mentors who are lay persons who are in~     recovery from depression can provide depression care services to older adults with~     depression. Older adults who are 50 and older will be screened for depression in the clinic~     and community. Those who meet criteria will be paired with a peer mentor for 8 meetings. Peer~     mentors will audiorecord their meetings with the patient and the recordings will be analyzed~     to assess what kinds of communication and behaviors the peer mentors engage in and what among~     those communications may be associated with relieving depression. The peer mentor will be~     trained and supervised by a psychiatrist and they will form a team to provide the depression~     care to the older adult. The study aims to relieve depressive symptoms and engage older~     adults in care. Both older adults and peer mentors wil be interviewed after the study to~     assess the strengths and weaknesses of peer mentor delivery of depression care. A manual will~     be developed describing the process and procedures of the study.~   "
99736|NCT02261805|"~     This is a Phase I/safety dose expansion study of the combination of the drug ganetespib and~     doxorubicin in patients with advanced solid tumors. The purpose of the Phase I part of the~     study is to determine the recommended phase II dose of ganetespib when given in combination~     with doxorubicin. The recommended Phase II dose determined at the end of the dose escalation~     phase will be used to conduct a safety dose expansion phase in relapsed/refractory small cell~     lung cancer to determine if there is a signal of efficacy in this population.~   "
99737|NCT02261792|"~     Spontaneous intracranial hypotension (SIH) is an infrequent disease, related to a leak of~     cerebrospinal fluid. There are not controlled studies for this treatment.The main of this~     study is to demonstrate the superiority of the Trendelenburg position compared to supine~     position during 24 hours after an epidural blood patch for a spontaneous intracranial~     hypotension~   "
99738|NCT02261779|"~     Longterm disease-free survival (DFS) of older patients with acute myeloid leukemia (AML)~     remains poor. The vast majority of AML patients relapses within two years after start of~     therapy1,2. In Acute Promyelocytic Leukemia (APL, AML M3), all-trans-retinoic-acid (ATRA;~     Tretinoin) induces differentiation and subsequently clinical remission. So far effective~     differentiation therapy does not exist in other AML subtypes. Recent preclinical data suggest~     that the combinatorial use of ATRA and tranylcypromine (TCP), an irreversible~     Monoamine-Oxidase (MAO) and Lysin-specific demethylase (LSD) inhibitor that also inhibits~     LSD1 (a histone H3 Lysine 4 demethylase), induces leukemia cell differentiation and leukemic~     stem cell exhaustion in vitro and in vivo in non-APL AML subtypes.~      In this Phase I/II study the investigators will explore the feasibility, safety, as well as~     efficacy and of Tretinoin/TCP treatment in patients with relapsed or refractory AML or in~     patients with AML who are not eligible for intensive treatment. Patients will be treated with~     daily increasing doses of TCP (initially 10 mg/day, then +10 mg each day up to 80mg/d). After~     7 days, ATRA will be added at a fixed dose (45 mg/sqm/day). Overall, 16 evaluable patients~     are going to be treated. The primary endpoint is the fraction of patients that achieve CR,~     CRp( complete response with incomplete recovery of platelets), CRi (complete response with~     incomplete recovery of granulocytes) and PR. Secondary endpoints are tolerability, safety as~     well as progression-free survival and overall survival. Serum levels of TCP will be regularly~     analyzed. Pharmacodynamic analyses will be performed with analyses of the inhibition of LSD1~     by TCP. Further analyses will address the changes in Histone H3 lysine 4 tri demethylase~     (H3K4me3) levels in AML blasts and the differentiation status of AML blasts.~      Taken together, this Phase I/II study will analyze feasibility, pharmacodynamics and~     effectivity of ATRA and TCP as differentiation therapy in AML.~   "
99739|NCT02261766|"~     This study will compare the two methods 5 days holtermonitoring and 30 days thumb~     electrocardiogram for detection of atrial fibrillation in stroke patients~   "
99740|NCT02261753|"~     The investigators are undertaking the first European Randomised Controlled Trial (RCT) for~     epilepsy surgery in children with FCD type II, to prospectively evaluate the role of the KD~     prior to surgery in improving seizure outcome. The investigators will evaluate the role of KD~     as a disease-modifying treatment to achieve seizure control and improve neurodevelopment and~     quality of life. Children age 3 - 15 years with pharmacoresistant epilepsy believed to be the~     result of focal cortical dysplasia type II, considered to be surgically treatable, will be~     randomised to either receive 6m treatment presurgery with a ketogenic diet, or to proceed~     direct to surgery (no pretreatment). Primary outcome will be the time to achieve a period of~     6 months of seizure freedom from the date of randomisation. Tissue resected at surgery will~     also be evaluated with regard to the degree of any methylation of DNA.~   "
99796|NCT02261025|"~     The aim of present study is to examine the effect of low-dose aspirin on the incidence of~     cardiovascular events and mortality in patients undergoing chronic hemodialysis.~   "
99741|NCT02261740|"~     The POPPY Study is a pilot of an Iyengar-based, therapeutic yoga program, used to treat~     pelvic or genital pain, in up to 16 women. Women aged 21 years and older who report~     persistent or recurrent pelvic or genital pain for at least 6 months that interferes with~     sexual activity will be recruited from the San Francisco Bay Area. Those who meet eligibility~     criteria will take part in a 6-week yoga therapy program designed by an expert yoga panel.~     Women will attend twice-weekly group classes focusing on Iyengar-based yoga techniques that~     have been carefully selected for their potential to improve women's genito-pelvic pain and~     practice yoga at home one additional hour a week.~      The investigators will evaluate changes in the severity and impact of women's pain using~     validated questionnaires and diaries.~   "
99742|NCT02261727|"~     The aim of this multi-centre, double blind, randomised, controlled trial (DBRCT) is to assess~     the effect of low dose theophylline, singly and in combination with low dose oral prednisone,~     on COPD (Chronic Obstructive Pulmonary Disease) exacerbations, quality of life and secondary~     clinical outcomes compared with usual therapy and placebo over 48 weeks of treatment.~     Approximately 2400 symptomatic patients with COPD will be recruited in China for comparison~     of low dose theophylline versus placebo and low dose theophylline + low dose prednisone The~     primary end-point for this study is the difference between the three treatment groups in~        -  COPD exacerbation rate~        -  Time to first severe exacerbation requiring hospitalisation or death~   "
99743|NCT02261714|"~     The purpose of this study is to investigate the effect of TG01 and Granulocyte macrophage~     colony stimulating factor (GM-CSF) when given in addition to gemcitabine (chemotherapy) and~        -  Understand any possible side effects of the additional use of TG01/GM-CSF with~          gemcitabine~        -  Investigate whether TG01/GM-CSF when given with gemcitabine can produce an immune~          response~        -  Investigate if the treatment can delay or reduce recurrence of the disease~   "
99744|NCT02261701|"~     A new postoperative regimen with a new bandage technique after surgery results in a better~     shoulder function and quality of life after surgery - than traditional postoperative regimen~     with shoulder lock and abductor cushion.~   "
99745|NCT02261688|"~     The overall goal of this study is to evaluate the association between sodium and TH17 cells~     in human subjects. The subjects will have levels of TH-17 and various hormones measured on~     low salt diet, low salt diet with intravenous normal saline, and high salt diet.~   "
99746|NCT02261675|"~     The study was designed to define the interaction of intravenous infusion of dexmedetomidine,~     an a2-adrenergic agonist, and sevoflurane in children having surgery by using the minimum~     alveolar concentration which can block adrenergic and cardiovascular responses to~     incision(MACbar) of sevoflurane as the measure of anesthetic potency.~   "
99747|NCT02261662|"~     This study will be conducted on 30 patients with mucocutaneous complaints and documented HCV~     infection. The study will be done at Tropical medicine department , Tanta university. It will~     be conducted between June2014 and November 2014.~      The aim of the study is to assess efficacy of Ribavirin in the management of mucocutaneous~     extrahepatic manifestations of HCV infection.~   "
99748|NCT02261649|"~     The purpose of the study is to evaluate how cerebellar resection surgery may affect pain~     sensation and the way the brain reads pain signals. By measuring brain activity in children~     and adolescents following surgery, the investigators hope to gain valuable information about~     pain processing in the brain.~   "
99749|NCT02261636|"~     For both induction of remission and in maintenance of remission, different doses and~     treatment durations are used in practice. The aim of this study is to assess how mesalazine~     is used in clinical practice, at which doses and for how long and how these differences~     impact the patient disease state and work productivity.~   "
99750|NCT02261623|"~     The purpose of this study is to document stent functionality and practice patterns in Canada~     pertaining to indications for use and stent type selection for self-expanding biliary metal~     stents (SEMS) when used per standard of practice.~   "
99751|NCT02261610|"~     The clinical manifestations of pulmonary embolism vary greatly from the absence of specific~     clinical symptoms to cardiogenic shock or cardiac arrest. Clinical form of EP represented by~     lung superinfection, also called pulmonary embolism superinfected is common and~     represents up to 30% of initial clinical presentations; she been few evaluations in clinical~     research. The reality of the bacterial infection remains controversial and the clinical~     presentation often leads to the prescription of empirical antibiotic therapy, often~     unnecessary in many cases. Number of antibiotic prescriptions are probably inappropriate.~      Fever has long been recognized as a sign associated with pulmonary embolism. Stein et al~     reported a temperature above 37.5 ° C on 50% of patients with acute pulmonary embolism~     without actually clarified whether this was related to temperature with a pulmonary embolism~     or other associated cause. Murray et al estimated that greater than 38 ° C was explained by~     pulmonary embolism in 57.1% of patients while in the PIOPED study, only 14% of patients had~     fever with no other cause identified as pulmonary embolism. Fever due to pulmonary embolism~     is often low intensity (often less than 38.3) and of short duration, with a peak on the day~     of pulmonary embolism and a gradual decrease of about 1 week. The pathophysiology of fever in~     pulmonary embolism has not yet was completely clarified. It is suggested that a combination~     of several factors involved pyrogenic myocardial tissue necrosis and releasing~     pro-inflammatory cytokines, hemorrhage, vascular irritation or inflammation, atelectasis or~     local superinfection.~      Since 2004, the PCT has become a marker helping the initiation of antibiotic therapy in~     patients with community-acquired pneumonia. This is especially verified in patients admitted~     for acute exacerbation of chronic obstructive bronchitis. In the latter case, the use of PCT~     reduces inappropriate antibiotic prescribing. Thus helping the clinician by measuring~     biomarkers such as PCT is based on writing an algorithm leading or not to use antibiotics.~      The use of an algorithm involving the PCT could just as for infectious pneumonia or COPD, of~     interest in the febrile pulmonary embolism to distinguish febrile forms related to bacterial~     infections febrile forms of EP to other causes.~   "
99752|NCT02261597|"~     The main purpose of this study is to understand how insomnia (compared to good sleep) may~     affect the response of the body to a repeated physiological challenge, such as inserting the~     hand in ice-cold water for several times in a row. In particular, the investigators are~     interested in the response of markers that can be associated with stress, such as blood~     pressure and stress hormones.~   "
99753|NCT02261584|"~     The aim of this study is to compare microwave thermal coagulation and partial splenic~     embolization in the management of hypersplenism in patients with cirrhosis.~      This study will be conducted on 40 patients with liver cirrhosis associated with splenomegaly~     and hypersplenism. The study will be done at the National Hepatology and Tropical Medicine~     Research Institute.~   "
99754|NCT02261571|"~     Most cancer patients experience multiple symptoms related to chemotherapy and use CAM~     (complementary and alternative medicine) as an adjunct to conventional treatment. Moxibustion~     is traditional Korean medical therapeutic method and uses the heat generated by burning~     herbal preparations containing Artemisia vulgaris to stimulated acupoint.~      Herein, the investigators propose an open-label pilot study investigating the effectiveness~     of moxibustion stimulation at abdominal acupoint on quality of life in cancer patients under~     chemotherapy.~   "
99758|NCT02261519|"~     The proposed Phase IIb/III study is designed to evaluate the safety and efficacy of NaBen® in~     improving the symptoms of schizophrenia in adults. NaBen® is granted Breakthrough Therapy~     Designation by US FDA as add-on treatment for schizophrenia. The trial is designed as a~     multi-center, prospective, randomized, placebo-controlled, in which adult subjects with~     schizophrenia will be enrolled. The study will include four parts: a 2 week Screening part, a~     4 week run-in part, an 8 week double-blind treatment part, and a 52 week Open-Label Extension~     part.~   "
99759|NCT02261506|"~     Bacteremia is a leading cause of mortality and morbidity in critically ill adults. Although~     bacteria in the bloodstream (bacteremia) may arise from variable infectious foci (most~     commonly central vascular catheter related, lung, urinary tract, intra-abdominal, or skin and~     soft tissue sources), because of the high attendant morbidity and mortality of bacteremia,~     these patients collectively represent a critically important group to study.~      The consequences of the excessive antimicrobial use for individual patients, range from rash,~     gastrointestinal upset and diarrhea, to anaphylaxis, neutropenia, renal failure, toxic~     epidermal necrolysis, death, and a marked increase in ICU and hospital drug costs. One~     particularly concerning complication, Clostridium difficile infection, has increased in~     incidence and severity over the past decade. Much of this burden could be prevented through~     reduction in unnecessary antibiotic use.~      Another major consequence of excessive antibiotic use is antimicrobial resistance. Antibiotic~     resistance is not only a concern for the patient who receives antibiotics, but also for~     neighbouring patients in the ICU, as well as future patients in the ICU and the hospital at~     large - through patient-to-patient transmission, and environmental contamination.~      No previous randomized controlled trials have directly compared shorter versus longer~     durations of antimicrobial treatment in these patients. The investigators will conduct a~     multi-center randomized concealed allocation trial of shorter duration (7 days) versus longer~     duration (14 days) antibiotic treatment for critically ill patients with bacteremia admitted~     to ICU. Eligible, patients will be randomized to either 7 days or 14 days of adequate~     antimicrobial treatment. The selection of type, dose and route of antibiotics will be at the~     discretion of the treating physicians, but the duration of treatment (7 versus 14 days) will~     be determined by randomization group. The randomization assignment will not be communicated~     to the study research coordinator, study critical care or infectious diseases investigators~     or clinicians until day 8. The primary outcome for the main trial will be 90-day mortality.~      The study will be initiated at Sunnybrook Health Sciences Centre in Toronto, Ontario, and~     then rolled out to a second site at Kingston General Hospital in Kingston, Ontario. These~     sites will be sufficient to meet the sample size goals for the pilot RCT, but if additional~     funds are obtained the investigators will also roll out to the other Canadian ICUs listed~     below. The goal of adding these additional sites will be to increase the generalizability of~     the findings with respect to trial feasibility~   "
99760|NCT02261493|"~     This is a safety and efficacy study of onabotulinumtoxinA in subjects with upper facial~     rhytides (forehead lines, glabellar lines, lateral canthal lines [crow's feet lines]).~   "
99761|NCT02261480|"~     Parvovirus B19 is a small virus that is the cause of fifth disease, a common infection in~     childhood. In people with sickle cell disease (SCD), parvovirus B19 infection causes the bone~     marrow to stop producing red blood cells temporarily, which can be life-threatening. A novel~     vaccine is currently in development for children with SCD. This study is the first step~     within a larger parvovirus B19 multi-institutional project that will help develop this new~     vaccine, as it will define the value and utility of using a novel assay for measurement of~     parvovirus-specific antibodies. The main objective is to investigate the relationship between~     the newly developed VP1u ELISA assay and the gold standard neutralization assay for~     parvovirus B19 infection.~      The most accurate test, called a neutralizing antibody assay, to see if a person has had or~     currently has the infection is very complex and expensive and would be very difficult to use~     in a large research study to test the new vaccine. A new and simpler test has developed. The~     main goal of this study, iSCREEN, is to find out if this new test works.~      There will be distinct labs performing the VP1u ELISA and the neutralization assays and the~     respective laboratories will not have access to each other's results for individual subjects.~     The VP1u ELISA will be performed at St. Jude Children's Research Hospital. Neutralization~     assays will be conducted at the National Heart, Lung and Blood Institute.~   "
99762|NCT02261467|"~     This is a safety and efficacy study of onabotulinumtoxinA in subjects with forehead and~     glabellar facial rhytides (frown lines).~   "
99763|NCT02261454|"~     Traditional postoperative care has been challenged recently to improve and speedup recovery~     (including the return of bowel function) such that patients can be discharged to home more~     quickly. This approach includes earlier mobilization of the patient, and introducing solid~     food sooner. Additionally, there is evidence in adults to suggest that sham feeding by~     chewing gum may also speed up bowel recovery so the patient may tolerate a solid diet~     earlier.~      The aim of this study is to determine if gum chewing can enhance bowel recovery in children~     who undergo abdominal surgery.~   "
99764|NCT02261441|"~     IBERICAN is a multicenter, longitudinal and observational population-based study of patients~     daily attended in Primary Care setting in Spain.~      This study is aimed to determine the prevalence and incidence of cardiovascular risk factors~     in adult population in Spain.~      Patients will be followed-up for a minimum period of 5 years, every 6 months or a lesser~     period when clinically required.~      It has been estimated that a total of 15,000 individuals will be included.~   "
99765|NCT02261428|"~     The study compares the effectiveness of Tiemann and Suction catheters, with regard to~     attempts to enter the trachea and the time required for the procedure.~   "
99766|NCT02261415|"~     This is a multicentre Vanguard randomized controlled trial (RCT) to evaluate the impact of~     tranexamic acid (TXA) on perioperative blood transfusion in patients undergoing liver~     resection. The rationale for this study includes: (1) experimental evidence supporting the~     use of TXA in other surgical populations; (2) lack of evidence in patients undergoing liver~     resection; (3) clinical uncertainty and extensive support amongst hepatobiliary surgeons,~     anaesthesiologists, and hematologists for this proposed trial; (4) a feasible and efficient~     study design; and (5) the importance of the question: incidence of blood transfusion in~     patients undergoing liver resection is high, and the consequences serious. Different regions~     of Canada are well represented in the selection of study sites and five major sites have~     committed to participate in the Vanguard trial, including: Sunnybrook Health Sciences Centre~     (Toronto), University Health Network (Toronto), Foothills Medical Centre (Calgary), McGill~     University Health Centre (Montreal), and Queen Elizabeth II Health Sciences Centre (Halifax).~     We will enroll 400 patients in this Vanguard study. This Vanguard study will assist us in~     determining the feasibility and planning of a definitive multicentre RCT across Canada. If~     the Vanguard study confirms feasibility, we will expand the trial to additional sites and~     proceed directly into the definitive trial (planned sample size = 1230 patients). The~     following is a brief schema and study outline of the trial.~   "
99911|NCT02259530|"~     The research project will offer psychotherapeutic treatment to Somali refugees with PTSD and~     comorbid khat dependence. In this case series, evidence-based techniques will be applied and~     adapted to the cultural background of Somali refugees in Kenya.~   "
99767|NCT02261402|"~     Medisinstart is a new service developed for use in Norwegian pharmacies. It is intended for~     patients that are about to start a new medicine for a chronic or long-term condition. It is~     based on research showing that problems with newly prescribed medicines appear rapidly and~     that a significant portion of patients quickly becomes non-adherent. The service consists of~     two follow-up consultations with a pharmacist. The first at 1-2 weeks and the second at 3-5~     weeks after start of the new medicine.~      The main purpose of this study is to investigate whether Medisinstart increases patients'~     adherence to the prescribed medication. Patients' beliefs about their medicines and their~     motivation for adherence will also be examined. The study also aims at revealing if~     Medisinstart has additional benefits for the patient, the society and the pharmacies.~   "
99768|NCT02261389|"~     The main purpose of follow-up in asymptomatic breast cancer patients during and after~     adjuvant treatment is to detect breast cancer recurrence and metastatic disease.The aim of~     this trial is to verify if, in asymptomatic patients, the serial measurement of serum CEA and~     CA 15.3, with diagnostic imaging procedures (18FDG-PET) performed only in case of a critical~     increase of serum CEA and CA 15.3 level, can anticipate the diagnosis of breast cancer local~     and distant recurrence compared to the usual follow-up practice.~   "
99769|NCT02261376|"~     This is an open label, non-randomised, single-dose, parallel-group study in 48 healthy~     subjects enrolled in 4 cohorts - Caucasian men, aged 18-55 years, Caucasian men, aged 65~     years or older, Japanese men, aged 18-55 years, Caucasian women, aged 18-55 years.~   "
99770|NCT02261363|"~     The universe of tobacco products is expanding, with new noncombustible products gaining~     popularity even as the reduction in prevalence of cigarette smoking slows or stalls.~     E-cigarettes, or Electronic Nicotine Delivery Systems (ENDS), are the most prevalent of these~     emerging noncombustible products. With sales increasing rapidly and more efficient pulmonary~     delivery devices under development, ENDS are likely to play an increasing role in the future~     tobacco market. Little is known about the cognitions and behaviors leading to or sustaining~     ENDS use. Smokers may use ENDS to subvert smoking restrictions, to reduce perceived smoking~     harms, or for smoking cessation. Evidence about ENDS use is emerging from national~     surveillance and laboratory research, but the majority of information on ENDS is limited to~     retrospective surveys and convenience samples of White male ENDS users. The investigators~     research suggests Black smokers are less likely than White smokers to try and be current ENDS~     users, perhaps due to a greater degree of perceived harm associated with ENDS, a preference~     for menthol, or cultural norms. Thus, it is timely and critical to study how all smokers,~     including Blacks and menthol smokers, experience and initiate ENDS use employing valid,~     innovative research methods.~   "
99771|NCT02261350|"~     To determine the feasibility of delivering different community nutritional interventions to~     chronic obstructive pulmonary disease (COPD) patients at moderate or severe risk of~     malnutrition following a hospitalisation for an acute exacerbation of COPD.~   "
99772|NCT02261337|"~     This study aims to assess usual walking speed (4-metre gait speed) and markers of sarcopenia~     predict mortality in patients with chronic respiratory disease.~   "
99773|NCT02261324|"~     This study aims to assess usual walking speed (4-metre gait speed) in patients undergoing~     primary percutaneous coronary intervention (PCI) for acute myocardial infarction and to~     assess whether this can predict future cardiovascular events and death.~   "
99774|NCT02261311|"~     The investigators will compare the differences in the scores between the baseline~     questionnaire (at diagnosis) and the second questionnaire (at treatment) in the RADS II~     patients that enrolled in pre-treatment trials versus those that don't.~   "
99775|NCT02261298|"~     The objective of this study is to investigate the safety, pharmacokinetics, pharmacology and~     efficacy of ONO-4538 administered to Korean patients with advanced or recurrent solid tumors~     who are refractory or intolerant to standard therapy or for whom no appropriate treatment is~     available.~   "
99776|NCT02261285|"~     The objective of the study is to investigate the pharmacokinetics of ONO-4538 administered to~     Korean patients with advanced or recurrent solid tumors who are refractory or intolerant to~     standard therapy or for whom no appropriate treatment is available.~   "
99777|NCT02261272|"~     The study will test an internet-based treatment for insomnia.~   "
99778|NCT02261259|"~     The overall goal of this project is to develop sensitive and objective clinical research~     tools for the assessment of head-neck motor control. In order to accomplish this goal, the~     investigators aim to quantify changes in head-neck motor control before and after osteopathic~     manipulative treatment. The investigators hypothesize that head-neck motor control will~     improve in neck pain participants after 4-weeks of treatment. Additionally, the investigators~     will compare position and force head-neck motor control between healthy controls and neck~     pain patients. The investigators hypothesize that baseline tests of position and force~     head-neck motor control will be better in healthy individuals than neck pain patients.~   "
99779|NCT02261246|"~     The overall goal of this project is to develop sensitive and objective clinical research~     tools for the assessment of trunk motor control. In order to accomplish this goal, the~     investigators aim to quantify changes in trunk motor control before and after spinal~     manipulation treatment. The investigators hypothesize that trunk motor control will improve~     in the low back pain participants after 4-weeks of spinal manipulation treatment.~     Additionally, the investigators will compare position and force trunk motor control between~     healthy controls and low back pain patients. The investigators hypothesize that baseline~     tests of position and force trunk motor control will be better in healthy individuals than~     low back pain patients.~   "
99794|NCT02261051|"~     Symptom Management, Quality of Life and Satisfaction with Care for Advanced Stage Cancers is~     the first part of a two part study (The Lancaster Cancer Care Model (LCCM) - Non-Concurrent~     Control Study). The primary aim of the study is to compare the proportion of advanced cancer~     patients who have a hospitalization or emergency department visit in the last 6 months of~     life before and after implementation of a new care model that provides more comprehensive~     symptom management and supportive care, including earlier referral to palliative care. The~     secondary comparative aim is to assess measures of quality of life and satisfaction in both~     groups. This current study is to collect data on the control group only. After system~     redesign, we will open an intervention arm study to collect data after implementation of the~     new care model (about 18-24 months from start of control phase).~   "
99780|NCT02261233|"~     The overall goal of this project is to develop sensitive and objective clinical research~     tools for the assessment of postural control of the trunk. In order to accomplish this goal,~     we aim to quantify balance performance in an unstable seated task. Specifically, the~     investigators will quantify balance performance in low back pain participants before and~     after osteopathic manipulative treatment. The investigators hypothesize that there will be a~     significant improvement in balance performance after a single session of osteopathic~     manipulative treatment as well as after 4 sessions of osteopathic manipulative treatment and~     this improvement will be greater than any learning effect.~      A secondary objective of this study is to quantify differences in patient-oriented outcome~     measures (e.g., self-reported pain, disability) in low back pain participants before and~     after osteopathic manipulative treatment. The investigators hypothesize that there will be a~     significant improvement in these self-reported outcomes following osteopathic manipulative~     treatment. The association between improvement in postural control parameters and~     patient-oriented measures will also be explored.~   "
99781|NCT02261220|"~     This is a multicenter, open-label, dose-exploration and dose-expansion study to evaluate the~     safety, tolerability, antitumor activity, PK and immunogenicity of MEDI4736 in combination~     with tremelimumab in subjects with select advanced solid tumors.~   "
99782|NCT02261207|"~     This is an investigator initiated, open label, prospective, non-randomized, phase II trial~     aimed at evaluating the activity of Axitinib in progressive VEGFR2 and/or PDGFRB positive~     advanced Solitary Fibrous Tumor (SFT) patients. Patients with a documented and centrally~     reviewed pathologic and radiologic diagnosis of progressive VEGFR2 and/or PDGFRB positive~     advanced SFT may enter in the study. Axitinib will be administered at the dose of 5mg twice a~     day, continuously. Treatment will be continued till evidence of progression, or toxicities or~     patient withdrawal.~   "
99783|NCT02261194|"~     The purpose of this trial is to determine the short-term effect of a self-care intervention~     on depression in patients with age-related macular degeneration or diabetic retinopathy.~   "
99784|NCT02261181|"~     There is a strong need to study products with a preemptive role in radiation dermatitis~     development, with a trial design taking in account patient subjective evaluation and~     compliance.~      XONRID is a promising device for radiation high grade dermatitis prevention; it is a topical~     gel that prevents and treats skin symptoms such as erythema, itching, burning sensation and~     pruritus, induced by radiotherapy or other causes.~   "
99785|NCT02261168|"~     This study evaluates the existence of a day-night rhythm in skeletal muscle energy metabolism~     in healthy lean subjects. Subjects will stay at the research facility for 44 hours with a~     standardized living protocol during which several measurements of skeletal muscle and whole~     body energy metabolism will be performed.~   "
99786|NCT02261155|"~     Changes in sensory thresholds and pain thresholds will be measured with quantitative sensory~     testing (QST) before and during hypnotic relaxation in healthy volunteers. Hypnotic~     susceptibility will be assessed before QST.~      QST data before and during hypnosis will be compared. Observed sensory changes will be~     evaluated in relation to the assessed hypnotic susceptibility~   "
99787|NCT02261142|"~     Spasticity is a common consequence of injury to the central nervous system and can be a major~     problem in motor function and everyday activities. A method for treating spasticity that~     applies low-amplitude electrical stimulation through a garment with built-in electrodes,~     Mollii® (Elektrodress), has been developed. The garment is to be used in combination with~     individualized training and the stimulation is mainly given to antagonists of spastic~     muscles.~      The general objective of this study is to evaluate the efficacy of and costs associated with~     the Mollii® treatment of spasticity due to stroke or cerebral palsy.~      Primary objectives are;~        -  to study whether treatment with the Mollii® improves function and activity~        -  to evaluate the cost-effectiveness of the treatment, from both a health-care perspective~          and a societal perspective.~      Secondary objectives are;~        -  to study whether there are differences in treatment effect between the stroke and the~          Cerebral Palsy groups in a subgroup-analysis~        -  to assess compliance with treatment~        -  to report any adverse effects.~   "
99788|NCT02261129|"~     Study to demonstrate the bioequivalence of the telmisartan 80 mg film-coated tablet vs. two~     tablets of the telmisartan 40 mg conventional tablet~   "
99789|NCT02261116|"~     Study to assess potential different properties of telmisartan, which due to its Vd, should~     result in stronger beneficial effects of AT1 blockade in tissues (e.g. aldosterone~     suppression and renin increase) plus stronger AT2 stimulation compared to candesartan~   "
99790|NCT02261103|"~     The objectives of the studies are:~        -  To demonstrate similar total exposure between pramipexole ER fasted and pramipexole ER~          fed after multiple administration of the highest daily dose of 4.5 mg q.d. and to reveal~          any food effect leading to uncontrolled release~        -  To investigate the relative bioavailability of the ER-formulation of pramipexole in~          comparison to the IR-formulation at the highest daily dose of 4.5 mg after multiple~          dosing~        -  To demonstrate dose proportionality between the dose strengths of the pramipexole ER~          formulation of 0.375, 0.75, 1.5, 3.0, and 4.5 mg after multiple daily (q.d.) dosing~   "
99791|NCT02261090|"~     Study to compare the oral bioavailability of seven prototype slow-release formulations to~     immediate-release tablets~   "
99792|NCT02261077|"~     Study to investigate pharmacokinetics, safety and tolerability of Buscopan® after single~     rising dose and after multiple rising doses~   "
99793|NCT02261064|"~     Study to investigate the relative bioavailability and pharmacokinetics of the fixed-dose~     combination tablets (telmisartan 40 mg/amlodipine 5 mg and telmisartan 80 mg/amlodipine 5 mg)~     in the fed condition compared with those of the same fixed-dose combination in the fasting~     condition in healthy Japanese male volunteers.~   "
99795|NCT02261038|"~     Femoral component rotation in total knee arthroplasty (TKA) has been considered an important~     factor for outcome. However, measurement of femoral component rotation is difficult to~     perform.~      Femoral TKA component rotation can be assessed on special radiographs (Kanekasu technique),~     axial CT slices and 3D reconstructed CT images.~      It was the hypothesis that measurements on radiographs are comparable to measurement on CT~     images.~      Measurements of femoral TKA rotation will be measured three times by three different~     observers and inter- and intraobserver reliability is calculated. The absolute values of each~     measurement method is noted in degrees.~   "
99797|NCT02261012|"~     This study aims for a better understanding of the pathophysiological mechanisms of the~     complex regional pain syndrome (CRPS). This will be done by testing the quantitative sensory~     testing, the remote ischemic conditioning, the conditioned pain modulation (CPM) and the~     analysis of the heart-rate variability in patients with CRPS and a control-group. We~     hypothesize decreased conditioned pain modulation, less effects of remote ischemic~     conditioning and an affection of the heart-rate variability in patients with CPRS.~   "
99798|NCT02260999|"~     In this study, the detection of the feigning weakness in grip strength is measured using~     different grip strength testing instruments. Patients with injury of the upper limb are~     compared to patients with injury of the lower limb as well as healthy controls.~   "
99799|NCT02260986|"~     The primary objective of the study was to demonstrate the efficacy of Dupilumab administered~     concomitantly with topical corticosteroid (TCS) through Week 16 in adult participants with~     moderate-to-severe atopic dermatitis (AD) compared to placebo administered concomitantly with~     TCS.~   "
99800|NCT02260973|"~     This is a randomized, masked, placebo controlled study to assess the effect on visual acuity,~     if any, of the PRN omega-3 nutritional supplement in subjects undergoing cataract surgery.~   "
99801|NCT02260960|"~     The investigators hypothesize that oral omega-3-acid triglyceride form will decrease dry-eye~     related symptoms as well as clinical markers associated with dry eye disease (TearOsmolarity,~     Schirmer-1 test values, corneal staining, and fluorescein tear break-up time) when compared~     to administration of placebo.~   "
99802|NCT02260947|"~     This study will examine the activity of 2 different doses of PF-06273340 on a panel of evoked~     pain tests carried out from 0.5 to 10 hours following oral dosing in healthy male subjects~   "
99803|NCT02260934|"~     In this experimental study, researchers will try to find out if treatment of lupus nephritis~     with a combination of rituximab and cyclophosphamide (CTX), or a combination of rituximab and~     CTX followed by treatment with belimumab is safe and if this drug combination can block the~     immune system attacks.~   "
99804|NCT02260921|"~     This purpose of this study is to evaluate the effectiveness and safety of the iovera° device~     for the temporary reduction of pain associated with knee osteoarthritis.~   "
99805|NCT02260908|"~     Victims of trauma with severe head injury who have bled into their brains are at high risk of~     developing blood clots in their legs. These blood clots can break off and travel through the~     bloodstream to the lungs, resulting in death. Blood thinners can be given to patients to~     prevent blood clots from developing but this can leave patients at risk for additional~     bleeding in the brain, causing further damage or death. The earlier blood thinners are~     started, the more effective they are at preventing blood clots. In addition, some patients~     with severe head injury who have bled into their brains will develop further bleeding even if~     they do not receive blood thinners. Even though a growing body of research has shown that the~     majority of bleeding in the brain stops within the first 24 hours after injury and that it is~     safe to start blood thinners as early as 24 hours after injury, doctors are still waiting~     longer than 4 days to start blood thinners in these patients over concerns of worsening~     bleeding. In Canada, almost half of the patients with severe head injury do not receive blood~     thinners until at least five days after injury. Delays in starting blood thinners appear to~     put patients at increased risk of developing blood clots, unnecessarily. This study will~     compare the benefits of starting low-molecular-weight heparin (LMWH), a type of blood~     thinner, early (36 to 48 hours after injury) versus the current practice (waiting until the~     6th day after being injured) in preventing blood clots in patients who have bled into their~     brains after severe head injury. The investigators believe that starting LMWH earlier will be~     more effective in preventing blood clots without worsening any bleeding when compared to~     waiting to start blood thinners. This study is called OPTTICH (OPtimal timing of~     Thromboprophylaxis in Traumatic IntraCranial Haemorrhage) and will be the largest Canadian~     investigator-initiated randomized control trial on blood clot prevention in trauma patients~     with severe head injury who have bled into their brains.~   "
99806|NCT02260895|"~     Diabetes is a major cause of morbidity and mortality worldwide. Prevention of diabetes is an~     important goal. The progression from impaired glucose tolerance to diabetes is thought to be~     promoted by the toxic effects of hyperglycemia on pancreatic beta cells. One of the main~     defects causing postprandial hyperglycemia in individuals with impaired glucose tolerance is~     reduced first phase (immediate) insulin release. The investigators hypothesis is that~     consuming a nutritional preload--a low-calorie, nutritionally balanced snack--30 minutes~     before ingesting a carbohydrate load, will moderate the hyperglycemic response to subsequent~     carbohydrate challenge and reduce glucotoxicity by stimulating insulin release and synthesis.~      The aim of this study is to test this hypothesis by comparing the standard 75-gram, two-hour~     oral glucose tolerance test (OGTT) response of 30 fasting adults who have impaired glucose~     tolerance to their OGTT response when the test is preceded by ½ ounce (14 grams) of~     dry-roasted, unsalted almonds. A pre-load interval of 30 minutes was chosen so that the peak~     of phase 2 (delayed) insulin response to the pre-load (45-60 minutes) would coincide with the~     timeframe of the steepest OGTT rise in glucose (15 to 30 minutes post challenge).~      The investigators hypothesize that the one-hour OGTT glucose level will be approximately 40~     mg/dl lower when participants consume the pre-OGTT almond snack, compared to their one-hour~     glucose level on the standard two-hour OGTT. The two-hour OGTT glucose level is unlikely to~     show a statistically significant difference between the almond pre-test snack and control~     standard OGTT conditions.~   "
99807|NCT02260882|"~     The purpose of this study is to determine if revaccination with pneumococcal vaccine~     (PNEUMOVAX™ 23, V110) is well tolerated and produces an immune response in older Japanese~     adults. The primary hypothesis being tested is that the geometric mean concentration of~     antibodies to pneumococcal polysaccharide serotypes 3, 6B, and 23F at 4 weeks after~     revaccination will be superior to that before revaccination in Japanese adults who received a~     primary vaccination at least 5 years before revaccination.~   "
99808|NCT02260869|"~     This is a single center randomized controlled trial. Approximately 102 patients will be~     randomized to one of two treatment groups: cooled radiofrequency or conventional monopolar~     radiofrequency ablation. Patients with chronic knee pain, with moderate to severe~     osteoarthritis according to the Kellgren-Lawrence scale for at least 6 months who have failed~     conservative therapy will be screened for the study.~      Then, patients will be enrolled based on reporting ≥50% pain relief after a fluoroscopic~     guided single diagnostic block of the geniculate nerves (superior medial, superior lateral,~     and inferior medial) with 0.5 ml of local anesthetic (2% Lidocaine).~      Baseline data will be collected for all enrolled patients. Outcomes will be measured at 1, 4,~     12, 24 and 52 weeks.~      Outcome measures will be: Visual analogue scale (VAS) both while at rest and during~     ambulation, Oxford knee scores, WOMAC, and global perceived effect.~   "
100047|NCT02257736|"~     The purpose of this study is to compare the radiographic progression-free survival (rPFS) of~     apalutamide in combination with abiraterone acetate (AA) plus prednisone or prednisolone~     (AAP) and AAP in participants with chemotherapy-naive (participants who did not receive any~     chemotherapy [treatment of cancer using drugs]) metastatic castration-resistant prostate~     cancer (mCRPC) (cancer of prostate gland [gland that makes fluid that aids movement of~     sperm]).~   "
99809|NCT02260856|"~     This is a randomized clinical trial of epiphysiodesis techniques: percutaneous transphyseal~     screw epiphysiodesis versus percutaneous drill epiphysiodesis for the correction of leg~     length discrepancy. Failed epiphysiodesis was selected as the primary outcome. Failed~     epiphysiodesis was defined as one or more of the following: development of angular deformity~     > 5°, revision epiphysiodesis, or growth inhibition < 70% of expected. EOS, low dose biplanar~     X-Ray, will be used to make all length measurements. Secondary outcomes assess mean growth at~     the physis following epiphysiodesis, in the subset of patients with bead implantation,~     fluoroscopy and operative times, length of stay, return to full weight bearing, as well as~     functional and quality of life outcomes. The following outcome scales will be used to measure~     pain (VAS), quality of life (PROMIS Pediatric Pain Interference Scale), and function (PROMIS~     Pediatric Mobility Scale, Pedi-FABS, and UCLA Activity Score). Each of these scales has been~     validated for use in children (Beyer, Denyes, & Villarruel, 1992; DeWitt et al., 2011;~     Fabricant et al., 2013; Novais et al., 2014; Varni et al., 2010a). We will also determine the~     cost associated with each technique and perform a cost-effectiveness analysis to establish~     which technique is preferred from a societal perspective.~   "
99810|NCT02260843|"~     Elderly insomnia is a serious public health problem. Current conventional approaches for~     treating insomnia are not suitable or effective in elderly population. It has been previously~     demonstrated that Tai Chi has definite advantages to be developed as self-help therapy in~     older adults and has been preliminarily demonstrated to improve sleep in older people. This~     project aims to evaluate the efficacy of Tai Chi training on alleviating chronic insomnia in~     older adults.~   "
99811|NCT02260830|"~     The purpose of this study is to investigate the pharmacokinetic (PK) properties of various~     modified release tablet formulations of Lu AF11167 (Part A) and to investigate the~     pharmacokinetic (PK) properties of a modified release tablet formulation of Lu AF11167 in a~     fed and fasted state and following multiple dosing (Part B).~   "
99812|NCT02260817|"~     This Phase 3 study will target approximately 100 men over age 18 who have a biochemical~     relapse or other evidence of relapse of prostate cancer after primary treatment.~      The purpose of this study is to:~      A. Provide expanded access the drug 11C-choline.~      B. Determine the performance characteristics (sensitivity, specificity, positive predictive~     value, negative predictive value) of 11C-choline PET/Computed Tomography (CT) and~     PET/Magnetic Resonance Imaging (MRI) in the detection of metastatic prostate cancer in~     patients with biochemical relapse of prostate cancer after primary treatment in a prospective~     manner.~      C. Determine the optimal Prostate-Specific Antigen (PSA) trigger value in 11C-choline PET/CT~     and PET/MRI positive patients through a prospective study.~      D. Determine factors that predict a confirmed positive 11C-choline PET/CT and PET/MRI using a~     multivariable analysis of clinical and pathologic data collected prospectively.~      E. Compare the individual performance characteristics of 11C-choline PET/CT and 11C-choline~     PET/MRI and the combination of 11C-choline PET/CT and PET/MRI~      Study Protocol:~        1. Patients entered into the study will undergo a 11C-choline PET CT scan and MRI scan.~        2. The CT and MRI images will be evaluated for evidence of metastatic prostate cancer.~        3. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic~          prostate cancer.~        4. Evidence of metastasis on conventional imaging or 11C-choline PET will be confirmed with~          biopsy or surgical pathology when possible, or by response to treatment on subsequent~          imaging.~        5. Rates of confirmed metastasis between conventional CT and MRI images will be compared~          with the 11C-choline PET CT and MRI images.~        6. Upon conclusion of each imaging protocol, the referring physician will receive written~          documentation of the results. At this time, the patient will be considered off study and~          no further follow up is required.~   "
99813|NCT02260804|"~     To demonstrate that CT-P10 is similar to Rituxan in terms of efficacy as determined by~     overall response rate at 7 months~   "
99814|NCT02260791|"~     The purpose of the study is to compare the effectiveness and safety of FKB327 in comparison~     to Humira® in rheumatoid arthritis patients who have inadequate disease control on~     methotrexate.~   "
99815|NCT02260778|"~     The purpose of this study is to determine if a Learning Collaborative is an effective tool to~     improve adoption and adherence to a Treat-to-Target (TTT) treatment strategy in U.S.~     rheumatology practices for the treatment of Rheumatoid Arthritis (RA). The TTT strategy has~     been embraced by the American College of Rheumatology through the RA Treatment Guidelines and~     by EULAR,however several lines of evidence suggest that TTT is not practiced consistently~     across rheumatology settings.Participating practices will be randomized to receive the~     Learning Collaborative intervention in one of two phases. Coaching consistent with Learning~     Collaborative practices will be used to promote adherence to TTT. Chart abstraction will be~     used to determine if the Learning Collaborative was an effective tool to increase TTT~     adherence.~   "
99816|NCT02260765|"~     The aim of the study is to evaluate the efficacy of the Deep TMS compare to TAU and the~     different in resource utilization of treating depression with Deep TMS compare to the TAU.~      The current study is a prospective semi-naturalistic, randomized study in which depressed~     patient who failed to respond to at least one medication or could not tolerate at least two~     antidepressants and are seeking for alternative treatment will be offered to join an open~     label study. The study designed as double arm study of which patient will have 50% chance to~     be randomized to one of the study groups.~      The study includes two arms. The dTMS study group will be treated according to the cleared~     FDA treatment protocol of 4 weeks of daily treatment following by additional 12 weeks of~     biweekly treatment and overall of 44 treatments. The Treatment As Usual arm will be treated~     by their primary care physician / psychiatrist according to the usual treatment recommend to~     the patient clinical status~   "
99817|NCT02260752|"~     The overall goal of this project is to better enable patients with uterine fibroids (UF) to~     make informed decisions about treatment options by leveraging the highest possible evidence~     of healthcare quality. The foundation of this project will be a multi-site, prospective~     registry of a diverse group of women who have undergone either medical or surgical treatment~     for UF.~      Specifically, the investigators are interested in: comparing management options for symptom~     relief; comparing management options for preserving reproductive function; and comparing~     effectiveness among different subpopulations, including consideration of patient needs and~     preferences of treatment options.~   "
99830|NCT02260583|"~     Chronic hypercapnic respiratory failure is common in stable COPD patients in a terminal phase~     of their disease In an attempt to correct or slow down the rate of rise of PaCO2, long-term~     noninvasive mechanical ventilation (NIV) has been proposed.~      Only very few studies demonstrated the clinical efficacy of NIV. Indeed this technique is not~     always well tolerated and therefore it may be effective only in a subset of patients The aim~     of this study is to assess the feasibility and safety of one shot extrcorporeal CO2 removal~     device, in reducing the PaCO2 level~   "
100048|NCT02257723|"~     This study investigates the effect of hospital-based intensive non-surgical treatment in~     musculoskeletal patients admitted to an integrated hospital that offers both complementary~     and alternative medicine (CAM) and conventional medicine treatment.~   "
99818|NCT02260739|"~     Recent advances in hematology clearly illustrate that the simple clonal nature of various~     hematological malignancies may not really reflect the reality of malignant cells natural~     expansion. This has been nicely illustrated in recent works in AML for example where~     subclones coexists in the same patient at the same time, but could also differentially expand~     over time because of effects of therapeutics intervention, but also by oncogenic spontaneous~     events (1).~      These observations have been done recently because of next generation sequencing that allows~     to discriminate in the same tumor samples, different subclones and to analyse the clonal~     architecture. Sequential analyses could help us to identify the first oncogenic event and to~     correlate disease progression to the emergence of subclones.~      For all these reasons it is of a major interest to precisely understand the architecture of~     the clone in MPNs, especially to understand which is the initiating event and how from this~     initial event the clone develops.~      In MPNs in which JAK2V617F is the initiating event, its targeting is expected to be extremely~     effective. If JAK2V617F is a secondary event its targeting might allow to alleviate the MPN,~     but may favor the development of other malignant hemopathies.~   "
99819|NCT02260726|"~     Patients are being asked to participate in this study because a previous research MRI of~     their hips showed that the shape of the head of their thigh bone may indicate FAI of the hip.~     We have already collected cartilage imaging data and data on how the hip joint moves on~     people with painful/symptomatic FAI and people with normal hip function. We would now like to~     compare the motion of the hip joint to those with painful FAI using ultrasound.~   "
99820|NCT02260713|"~     Pilot study on 7 subjects in each group (total 21 subjects) to establish the safety and~     feasibility of autologous bone marrow cell transplantation in case of acute complete spinal~     cord injury by each of the following techniques and a corresponding number of controlled~     subjects:~        -  Directly into the injured site with a syringe after exposing the spinal cord.~        -  By Intrathecal injection.~   "
99821|NCT02260700|"~     The purpose of this study is to determine pharmacokinetics (the study of the way a drug~     enters and leaves the blood and tissues over time) and the relative-bioavailability (the~     extent to which a drug or other substance becomes available to the body) of JNJ-54861911~     solid dosage formulation compared with JNJ 54861911 oral suspension formulation in healthy~     older male participants.~   "
99822|NCT02260687|"~     The objectives of this study are to investigate the safety and effectiveness of EYLEA.~   "
99823|NCT02260674|"~     The purpose of this study is to evaluate the long-term safety and tolerability of~     JNJ-54861911 during 6 months of treatment in participants with early (predementia)~     alzheimer's disease (AD [degenerative disease of the brain characterized by the insidious~     onset of dementia, impairment of memory, judgment, attention span, and problem solving skills~     are followed by severe apraxias and a global loss of cognitive abilities]).~   "
99824|NCT02260661|"~     First time in patients study of AZD8835. The study has four parts. Part A AZD8835 is~     administered as a single agent in a multiple ascending dose escalation phase to investigate~     dose level for monotherapy. Part B follows the multiple ascending dose phase, additional~     patients with tumors with documented PIK3CA gene mutation will be enrolled to a single dose~     expansion phase. Part C is a second dose escalation phase in which post-menopausal patients~     with estrogen receptor positive (ER+), HER2 negative breast cancer will receive AZD8835 in~     combination with fulvestrant. Part D follows the combination dose escalation phase of the~     study, additional postmenopausal patients with ER+/HER2 negative breast cancer with~     documented PIK3CA gene mutation will be enrolled to a AZD8835 and fulvestrant combination~     dose-expansion phase at maximum tolerated dose or recommended phase II dose.~   "
99825|NCT02260648|"~     The main purpose of this study is to evaluate the efficacy and safety of the study drug known~     as evacetrapib when administered in combination with atorvastatin for 12 weeks in Japanese~     participants with primary hypercholesterolemia.~   "
99826|NCT02260635|"~     The main purpose of this study is to evaluate the efficacy and safety of the study drug known~     as evacetrapib in Japanese participants with primary hypercholesterolemia. The double blind~     treatment period will last for 12 weeks and the open-label extension period will last for an~     additional 40 weeks.~   "
99827|NCT02260622|"~     Background: Up to 10% of patients with peripheral arterial disease (PAD) will develop~     critical limb ischemia (CLI) which is a decrease of blood flow in the arteries of the limb.~     CLI results in resting pain, ulcers, gangrene, and limb loss. The outcome for patients with~     CLI is poor. Within 3 months of onset, 12% of patients will require an amputation (removal of~     part of the limb) and 9% will die of major cardiovascular events (heart attack or stroke).~     Percutaneous angioplasty (PTA), a procedure used to open the blockages in blood flow, has~     become the first-line treatment for CLI given its effectiveness, lower cost, and lower risk~     of complications. However, 40% of patients will have re-narrowing of the arteries~     (restenosis) following the PTA procedure. This is thought to happen in part due to build up~     of blood cells called platelets which can also lead to the formation of blood clots. In order~     to try to avoid this problem, most patients are prescribed a combination of two blood~     thinning medications, acetylsalicylic acid (ASA or aspirin) and clopidogrel (the brand name~     is Plavix).~      The purpose of this study is to determine if a new blood thinner called rivaroxaban, given in~     combination with aspirin, would be more effective in preventing re-narrowing of the arteries~     than the current standard of care (aspirin and clopidogrel).~      Rivaroxaban is a pill and does not require blood test monitoring. It has been approved by~     Health Canada for use in prevention of blood clots in patients undergoing hip or knee surgery~     and to treat patients with blood clots in their legs and lungs. Low dose aspirin has been~     approved for reducing the risk of heart attacks and strokes. These medications have not been~     tested together in patients for prevention of re-narrowing of their arteries~      This is a pilot study conducted at one center, The Ottawa Hospital.~      It is a Phase 2 open label randomized controlled trial.~      Following the PTA procedure, once all inclusion/exclusion criteria are met, the participant~     will be randomized into one of two groups:~        1. Rivaroxaban 2.5 mg BID X 90 days plus ASA 81 mg daily OR~        2. Clopidogrel 75 mg daily X 90 days plus ASA 81 mg daily~      Visits will occur at 7 days, 30 days, 90 days, 6 months and 12 months. Participants will be~     followed for 12 months (± 14 days) in total. All adverse events will be collected for the~     duration of the study.~   "
99828|NCT02260609|"~     A multicenter, open-label, single-arm study to evaluate the safety and efficacy of~     GrafixCORE® for the treatment of complex diabetic foot wounds with exposed tendon and/or~     bone.~   "
99829|NCT02260596|"~     A retrospective cohort of solid organ transplant (SOT) and hematopoietic stem cell transplant~     (HSCT) recipients will be assembled to determine the incidence of respiratory viral~     infections diagnosed during an inpatient admission in the first year post-transplant. A~     sub-cohort of patients that develop a respiratory viral infection within one year of~     transplantation will be leveraged to investigate factors associated with mortality in the~     three months after respiratory viral infection.~   "
100049|NCT02257710|"~     Clinical evaluation of the Orsiro LESS in subjects requiring coronary revascularization with~     Drug Eluting Stents (DES). 500 subjects will be enrolled in this registry.~   "
99831|NCT02260570|"~     The ability to regulate impulses enables us to plan for the future, to maintain focus in the~     face of distractions (i.e. to encode memories), and to manage emotions. This self regulation~     can be compromised in individuals who have a history of mild traumatic brain injury and~     co-occurring disorders. In this study the investigators are using functional MRI scanning to~     understand how memory and self regulation are expressed in the brains of people with a~     history of mild traumatic brain injury. The investigators are also testing whether the~     medication tolcapone may improve memory and self regulation.~   "
99832|NCT02260557|"~     The primary objective of the study is to determine the activity of selexipag on Raynaud~     attack frequency in subjects with Raynaud's Phenomenon (RP) secondary to Systemic Sclerosis~     (SSc).~   "
99833|NCT02260544|"~     Bioequivalence study is proposed to be carried out on patients of ovarian cancer, who are~     already receiving or who in the opinion of their treating physicians are candidates for~     Doxorubicin liposomal injection therapy .~   "
99834|NCT02260531|"~     This research study is evaluating the effectiveness of the drug called cabozantinib (alone or~     in combination with trastuzumab) as a possible treatment for advanced breast cancer in which~     the cancer has spread to the brain.~   "
99835|NCT02260518|"~     The purpose of this study is to examine the impact of a lifestyle intervention on gestational~     weight gain, postpartum weight loss, and other secondary outcomes relative to a usual care~     control group.~   "
99836|NCT02260505|"~     This is a 2 arms study concerning patients with primary GIST who followed an Imatinib~     adjuvant treatment for 3 years after surgery and who have a high risk of recurrence.~      In the first arm, patients will continue Imatinib treatment for 3 more years, allowing to~     determine if the continuation of this treatment is efficient for disease control, in terms of~     Disease Free Survival improvement.~      In the second arm, patients will discontinue the Imatinib treatment, as standard practice.~     This arm will allow to determine if the re-introduction of Imatinib at relapse is still an~     efficient treatment for the control of disease.~   "
99837|NCT02260492|"~     This is a study to establish the equivalence of OT329 Solis and Advair Diskus when~     administered by inhalation in patients with asthma.~   "
99838|NCT02260479|"~     The primary aim was to investigate if preheated skin disinfection with Chlorhexidine in~     alcohol was non-inferior compared to room-temperature regarding skin colonization as well as~     bacterial colonization in wound, skin temperature and patients experiences.~   "
99839|NCT02260466|"~     Background: The prevalence of both senile cardiac amyloidosis (CA) and aortic stenosis (AS)~     markedly increases with age. Aortic stenosis increases left ventricular pressure overload.~     Cardiac deposits have been observed in AS and the amount of these deposits has been~     correlated to post-surgical outcome. As they are strong echocardiographic and cardiac MRI~     imaging similarities between CA and AS, the investigators hypothesized that the deposit~     observed in AS is transthyretin amyloid deposit. The investigators objective is to~     demonstrate that amyloid deposit is associated with poor outcomes following aortic stenosis~     surgical valve replacement.~      Materiel and methods: 180 patients with indication for surgical aortic valve replacement will~     be recruited prospectively and consecutively in 5 French centers. A replicative study will be~     performed in one Austrian center. Echocardiography, cardiac MRI and bone scintigraphy will be~     performed prior to surgery. During surgery, a basal LV septum biopsy will be collected for~     determination and quantification of interstitial deposits using specific staining which will~     be performed in a blind fashion. Clinical outcomes will be recorded during the~     hospitalization period following the surgery and at 1 year. Alive and re-hospitalization~     status will be determined. Patients will be classified according to the presence or not of~     amyloid deposits.~      Expected results and impact: This study will emphasize how pressure overload stress~     accelerates and magnifies amyloid deposition usually known to be related to cardiac aging~     process. It will develop reliable imaging tools and markers to detect cardiac amyloid~     deposition. Correlation between anatomopathologic analyses and the three different imaging~     technics will identify accurate imaging markers of CA. A risk stratification model based on~     amyloid deposits level for the clinical management of these patients will be created~     combining imaging and biological markers.~   "
99840|NCT02260453|"~     The purpose of this study is to evaluate the potential benefit of systematic preoperative~     coronary angiography followed by selective coronary artery revascularization on the incidence~     of myocardial infarction (MI) in patients without a history of coronary artery disease (CAD)~     and undergoing carotid endarterectomy (CEA).~   "
99841|NCT02260440|"~     This is an open label, single-arm, Phase 2 trial to evaluate the anti-tumor activity, safety,~     and tolerability of Pembrolizumab in combination with azacitidine in subjects with~     chemo-refractory mCRC without any further standard treatment options~      Dosage and regimen for all study periods~        -  Pembrolizumab will be given at 200 mg every 21 days.~        -  Azacitidine will be given at 100 mg daily subcutaneous injection on days 1-5 every 21~          days.~      The first assessment of tumor response will be performed after cycle 3 (9 weeks), and~     thereafter approximately every 9 weeks, every 3 cycles of therapy. The modified RECIST 1.1~     will be used to establish disease response or progression.~      All patients will be evaluated and graded for adverse events according to the NCI Common~     Terminology for Adverse Events, version 4.0 (NCI-CTCAE).~   "
99842|NCT02260427|"~     Supraglottic airway devices (SADs) are well established in anesthetic practice. Among these~     devices, the i-gel has been typically widely used. The self-pressurised air-Q intubating~     laryngeal airway (air-Q sp) is newly developed supraglottic airway devices. It is a new~     single-use device that may optimise the airway sealing while reducing the potential for~     postoperative complications such as sore throat. The overall structure of the air-Q sp is~     similar to the original air-Q, except the inflatable cuff. The aim of this randomized trial~     was to compare the clinical performance of the i-gel and the air-Q sp in elderly patients~   "
99855|NCT02260258|"~     The main purpose of this study is to evaluate if neuromuscular blockade improves lactate~     clearance (and preliminary secondary clinical outcome measures) as compared to usual care in~     post-cardiac arrest patients undergoing targeted temperature management.~   "
99856|NCT02260245|"~     TeamSTEPPS (Team Strategies and Tools to Enhance Performance and Patient Safety) is an~     evidence-based teamwork system designed to improve communication and teamwork skills among~     health professionals. The program was developed by the Agency for Healthcare Research and~     Quality (AHRQ) and the Department of Defense's Patient Safety Program as the national~     standard for team training in health care.~      The purpose of this study is to evaluate the effect of the TeamSTEPPS program on the team~     knowledge, skills and attitudes and patient safety at Planned Parenthood affiliates~     nationwide.~      The investigators hypothesize that implementation of the TeamSTEPPS program will be~     associated with improved team knowledge, skills, and attitudes; clinical outcomes; and~     process outcomes.~      Aims:~        1. To assess the effect of the TeamSTEPPS training program on team communication and~          effective team work~        2. To assess the effect of the TeamSTEPPS training program on process outcomes~        3. To assess the effect of the TeamSTEPPS training program on clinical outcomes~   "
99843|NCT02260414|"~     In cancer, the incidence of venous thromboembolism (VTE) is particularly high in patients~     with myeloma, especially when it is de novo and treated with thalidomide, lenalidomide or~     erythropoietin. Curiously, the prevention of VTE with LMWH (low-molecular-weight heparin) in~     myeloma seems no more effective than that achieved with aspirin, while the effectiveness of~     the latter in the primary prevention of VTE has never been demonstrated regardless of the~     type of population considered. Meanwhile, a biological study showed that prophylactic doses~     of LMWH in patients with different types of cancer did not always optimal reduction of~     thrombin peak during the 24 hours following the injection of LMWH. These clinical and~     biological studies lead to the conclusion that patients with myeloma may be resistant to the~     usual doses of preventive LMWH, which may explain the failure of prevention.~      Initially we intend to investigate whether this resistance to prophylactic doses of LMWH is~     present in patient's biology and if this resistance is specific to myeloma in hematological~     cancers. For this, we propose to study the evolution of thrombin generation by~     Thrombinography during 24 hours after subcutaneous injection of 4500 anti-Xa IU Tinzaparin in~     6 patients with de novo myeloma whit high thrombo embolic risk ie treated with thalidomide,~     lenalidomide or erythropoietin. LMWH is Tinzaparin chosen because it does not accumulate in~     patients with impaired renal function, and has a greater anti-biological activity thrombotic~     than other LMWH.~      To assess whether the observed pattern of thrombin generation is particularly multiple~     myeloma, we will take the same study in 6 patients with aggressive lymphoma and 6 medical~     patients hospitalized for acute heart and respiratory failure.~   "
99844|NCT02260401|"~     Spinal stenosis is one of the most common causes of low back pain among older adults and can~     result in significant disability. Despite this, it still isn't known which treatments are~     most effective or what outcomes are most important to these older adults. Through a Patient~     Centered Outcomes Research Institute (PCORI) contract, the investigators are building on the~     existing infrastructure of an AHRQ-funded (ARRA CHOICE award) comparative effectiveness~     research (CER) trial of epidural steroid injections (ESI) for spinal stenosis (the LESS~     trial) to address several critical research questions. The proposed study will answer the~     following key questions. Do decision aids tailored to older adults with spinal stenosis~     change patient decision-making regarding subsequent treatments? Do patients respond~     differently at subsequent outcome assessments time-points after receiving tailored decision~     aids that contain their own individual outcome data from prior treatments? The investigators~     hypothesize that providing these individualized reports will allow patients to make more~     informed choices regarding subsequent treatments, leading to reduced use of ineffective~     treatments and improved outcomes overall.~   "
99845|NCT02260388|"~     The purpose of this large comparative effectiveness study led by Richard J. Barohn, MD, of~     the University of Kansas Medical Center, is to learn about the safety and effectiveness of~     nortriptyline, duloxetine, pregabalin and mexiletine in treating cryptogenic sensory~     polyneuropathy (CSPN).~   "
99846|NCT02260375|"~     The general aim of the present study is to test a cell therapy with third-party allogeneic~     ex-vivo expanded MSCs as a strategy to induce tolerance in liver transplant recipients. MSCs~     will be prepared accordingly to established protocols , starting from diagnostic samples of~     bone marrow aspirates (2-5 mL) or using the remnants in the bag and filter at the end of the~     bone marrow infusions. From these samples, MSCs will be expanded in GMP approved facilities~     and used for the present study in patients undergoing liver transplantation.~   "
99847|NCT02260362|"~     The complex congenital cardiac malformations are a significant number of different diseases,~     each having specific natural histories. The interface with pulmonary arterial hypertension~     (HTAP) is high since the physiology of many of these disorders comprises alterations in~     pulmonary vasculature.~      This observatory is a cohort of 400 patients enrolled in 3 years, older than one month,~     having been informed and have agreed to participate in the study and with congenital heart~     disease other than patent foramen ovale as well as a diagnosis of pulmonary hypertension~     confirmed by cardiac catheterization.~      The main objectives of this report are to know~        -  Incidence of congenital heart disease in HTAP France.~        -  Describe the natural history of HTAP in a large population of patients Congenital heart~          disease in France~        -  The characteristics of HTAP congenital heart disease~        -  Having a cohort study~   "
99848|NCT02260349|"~     Prostate cancer, with more than 70,000 new cases and 8900 deaths a year in France, is a major~     public health problem. Until 28% of patients treated with surgery will present a positive~     surgical margin resulting in an incomplete clearance of the tumoral process and exposing so~     the patient at a local, systemic recurrence and increased morbidity. An increasing number of~     international publications have shown (ICG) was interesting for the detection of the sentinel~     lymph node, in the surgery of tumors of type hepatocarcinoma and liver metastases from~     colorectal diseases, but also in the surgery of the kidney, bladder or breast. ICG has~     affinity for tumor and tissues around the tumor related to micro-vascular histology for a~     localized and specific deposit (EPR effect).~      The detection of ICG 's deposits is now possible with to the use of a device which allow to~     visualize the infra-red fluorescence (NIR; Near Infra-Red) for objects larger than 0.15 mm.~     Thanks to this feature, the location of residual tumor tissue when performing a radical~     prostatectomy could be made much easier.~   "
99849|NCT02260336|"~     The purpose of this study is to evaluate the effect of Panax Notoginseng Powders on Rheumatic~     Pain.~   "
99850|NCT02260323|"~     To evaluate the compliance of traditional Chinese medicine (TCM) in young people with Chronic~     rheumatic disease~   "
99851|NCT02260310|"~     The purpose of this study is to evaluate the effect of acupuncture protocol involving in~     Weizhong (BL4) and Huantiao (GB30) points in treating ankylosing spondylitis.~   "
99852|NCT02260297|"~     70 overweight or obese adults with sleep disorders will be recruited for this study, in which~     the investigators aim to compare wrist actigraphy with polysomnography (PSG) for sleep~     monitoring. It is to evaluate the applications of Jawbone Up2 with the sleep parameters~     derived from this actigraphy.~   "
99853|NCT02260284|"~     The purpose of this study is to evaluate the efficiency of acupuncture in treating chronic~     low-back pain~   "
99854|NCT02260271|"~     Create a database with selected medical information on infants born with hypoxic-ischemic~     encephalopathy (HIE). In addition, the following samples will be collected in a~     bio-repository for future studies: blood, urine, and buccal samples.~   "
99857|NCT02260232|"~     Objective: To investigate the effects of a one-year worksite individual exercise intervention~     on lifestyle-related modifiable health risks, physical capacity and work performance.~      Methods: Two hundred ninety-five employees volunteered to participate (n=191 women, n=104~     men), aged 38 ± 8 years and body mass index (BMI), 24.71 ± 3.79. Measures of physical~     activity levels were assessed by the long self-administrated version of the International~     Physical Activity Questionnaire-Long Form (IPAQ-L), and all subjects performed a maximal~     cardiopulmonary treadmill graded exercise test. Blood samples and anthropometry measures were~     collected from participants at baseline survey, at 6 months and 1-year after. Components of~     the program included supervised moderate to high intensity cardiorespiratory exercise,~     resistance training, and flexibility.~   "
99858|NCT02260219|"~     Objective: Prospectively evaluate the safety and efficacy of the Ahmed Glaucoma Drainage~     Device, model M4 compared with the model S2.~      Method: Mexican patients with Neovascular Glaucoma will be randomly included for each group~     (M4 and S2). They will be operated using conventional techniques and creating a~     sub-episcleral tunnel to place the valve's tube in the anterior chamber. They will be~     monitoring for one year and the results will be evaluated with respect to a postoperative~     reduction in pressure, changes in visual acuity, the need for drugs and complications, in~     addition to the demographic characteristics of each group.~   "
99859|NCT02260206|"~     The effects colchicine administration for acute pericardial effusion after radiofrequency~     catheter ablation (RFCA) of atrial fibrillation on the recurrences of arrhythmia.~   "
99860|NCT02260193|"~     The purpose of this study is to evaluate the hemoglobin response (efficacy), safety, and~     tolerability of orally administered AKB-6548 in subjects with end stage renal disease~     undergoing chronic hemodialysis.~   "
99861|NCT02260180|"~     The purpose of this study is to evaluate the safety and dose-response of 2 concentrations of~     A-101 versus a vehicle control in the treatment of seborrheic keratosis.~   "
99862|NCT02260167|"~     Treating with measures that may improve metabolic functioning of neurons in an integrated~     protocol~   "
99863|NCT02260154|"~     Prospective, multicenter, non-comparative, observational program designed to assess the~     effectiveness of a 2-6 weeks treatment with Duspatalin® 200mg BID and changes in quality of~     life in patients with post-cholecystectomy gastro-intestinal spasms~   "
99864|NCT02260141|"~     To study the effectiveness of d-ribose in treating Alzheimer's and Dementia~   "
99865|NCT02260128|"~     Every patient undergoing surgery in the abdomen will experience temporary paralysis of bowel~     function. This study evaluates whether chewing gum can reduce the bowel paralysis after~     surgery in patients undergoing either esophageal resection or whipples procedure. Half the~     study population will receive chewing gum while the other half will act as control.~   "
99866|NCT02260115|"~     The purpose of this study is to obtain data on the safety and manageability of applying LABS™~     to the uterus and other areas of surgical trauma in the pelvis and abdomen following~     laparoscopic gynaecologic surgery. In addition, performance data following a clinical~     indicated second look laparoscopy will be collected for the purpose of determining sample~     size predictions for future trials.~   "
99867|NCT02260102|"~     Temocillin (6-methoxy-ticarcillin) is a beta-lactam antibiotic with exceptional resistance to~     most beta-lactamases. In this context, it is now increasingly used as carbapenem-sparing~     antibiotic in patients with suspected infection by Enterobactreriaceae suspected to produce~     extended-spectrum beta-lactamases. Little is known about dosing and elimination of temocillin~     in children. While available literature of temocillin use in paediatrics refers mainly to its~     clinical efficacy in the treatment of urinary tract infections, the drug is also used for the~     treatment of suspicion of cholangitis in cirrhotic paediatric patients, and as antibiotic~     prophylaxis following an hepatic transplant in children (both off-label indications). There~     is, therefore, a pressing need to explore the pharmacokinetics and pharmacodynamics of~     temocillin in the paediatric population, in order to provide clear guidance on an appropriate~     dosing regimen. The study objectives are: (1) characterisation of the pharmacokinetics (PK)~     of temocillin in 3 paediatric populations, (2) proposal and development of a dosing schedule~     that can ensure therapeutic concentrations (40% ƒT > MIC) and optimize treatment chances of~     success, and (3) characterization of MICs of microbiological strains (when available) to~     temocillin.~   "
99868|NCT02260089|"~     To evaluate the efficacy and tolerability of telmisartan, given once a day to patients with~     mild to moderate hypertension, as well as to assess the 24-hour blood pressure profile with~     ABPM~   "
99869|NCT02260076|"~     To assess the safety and tolerance of 5 mL to 20 mL PEG 400 in multiple rising doses~   "
99870|NCT02260063|"~     To assess the bioequivalence of two galenic formulations for epinastine (Flurinol®): syrup~     and 20 mg tablets~   "
99871|NCT02260050|"~     To establish the bioequivalence of the new formulation of WAL 801 CL dry syrup vs. the~     conventional formulation of WAL 801 CL dry syrup~   "
99872|NCT02260037|"~     Safety, tolerability and pharmacokinetics~   "
99873|NCT02260024|"~     The primary objective of the study was to estimate the magnitude of the error in the~     prediction of in vivo bioavailability (AUC0-30,Cmax) by means of in vitro dissolution data~     applying the methods of IVIVC. The secondary objective of the study was to investigate~     whether the intake of food 30 minutes prior to drug administration affects the systemic~     exposure of pramipexole SR C2 or not~   "
99874|NCT02260011|"~     The objective of this study was to compare the bronchodilator efficacy and safety of~     ipratropium bromide HFA-134a inhalation aerosol and marketed, Atrovent® CFC Inhalation~     Aerosol in COPD patients~   "
99875|NCT02259998|"~     To investigate the relative bioavailability of the proposed formulation of PERSANTIN®~     compared to the present commercial formulation.~   "
99876|NCT02259985|"~     food interaction, pharmacokinetics, safety and tolerability~   "
99877|NCT02259972|"~     To investigate the safety, tolerability, and pharmacokinetics incl. dose proportionality of~     BI 113823, as well as the relative bioavailability of PiB vs. tablet and tablet fasted vs.~     fed (food effect for the tablet).~   "
99878|NCT02259959|"~     To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 1744 CL and~     Tiotropium Bromide when given as fixed dose combination~   "
105760|NCT02183077|"~     Study to gain information on the percutaneous absorption of meloxicam after administration of~     a topical gel over 7 days.~   "
99879|NCT02259946|"~     Study to investigate safety and tolerability of single, inhaled doses (2.5 μg, 5 μg, 10 μg,~     20 μg and 40 μg) of BI 1744 CL in free dose combination with tiotropium bromide 5 μg (for~     doses up to and including 20 μg BI 1744 CL) and 10 μg (for doses of 20 μg and 40 μg BI 1744~     CL), both administered by Respimat® in healthy male volunteers. Also, to investigate the~     pharmacokinetics of BI 1744 BS and tiotropium bromide in such combinations, to explore their~     dose proportionality, and to explore the pharmacodynamic effects of the treatments on~     selected metabolic and respiratory parameters~   "
99880|NCT02259933|"~     Study to investigate safety, tolerability and pharmacokinetics of KUC 7483 CL after repeated~     dosing~   "
99881|NCT02259920|"~     Study to determine and compare the absorption of KUC 7483 CL from different regions of the GI~     tract with the immediate release formulation and to compare the absorption of particulate~     versus solution formulations from the ascending colon~   "
99882|NCT02259907|"~     Study to investigate safety, tolerability and pharmacokinetics of KUC 7483~   "
99883|NCT02259894|"~     To assess safety, tolerability, pharmacokinetics, and pharmacodynamics of BIRT 2584 XX in~     single rising oral doses of 5 mg to 700 mg in a polyethylene glycol 400 (PEG 400) solution in~     healthy subjects~   "
99884|NCT02259881|"~     To compare with placebo the anticoagulant activity of three dosages of BIBT 986 on parameters~     of coagulation, platelet activation and inflammation in a model of tissue factor triggered~     activation of the coagulation system; to examine the safety of BIBT 986 in this setting~   "
99885|NCT02259868|"~     1. To investigate the relative bioavailability (BA) of improved tablet formulation~          candidates to determine which formulation will be developed for use in late Phase II and~          Phase III clinical trials~        2. To investigate the relative BA of the pediatric suspension, compared to the current 1B~          formulation~        3. To investigate the bioequivalence (BE) of BILR 355 BS in two tablet strengths; three~          25mg tablets vs. one 75 mg tablet, current 1B formulation~   "
99886|NCT02259855|"~     The primary objectives were:~        -  To determine the effects of steady state TPV co-administered with low dose RTV on steady~          state PegIFN and RBV in HIV negative subjects with mild hepatic impairment (scheme A)~        -  To determine the effects of steady state of pegylated interferon (PegIFN) and RBV on~          steady state pharmacokinetics of TPV co-administered with low dose RTV in HIV negative~          subjects with mild hepatic impairment (scheme A)~        -  To determine the pharmacokinetics of single dose and steady state TPV/r 500/200 mg in~          subjects with moderate hepatic insufficiency (scheme B)~   "
99887|NCT02259842|"~     Evaluation of safety, tolerability and PK of single rising oral doses of BI 34021 FU2 in~     healthy male volunteers; comparison of 100 mg drinking solution vs. tablet, assessment of~     food effect by re-dosing at 50 mg and 150 mg~   "
99888|NCT02259829|"~     Study to demonstrate the bioequivalence of 40 mg telmisartan / 5 mg amlodipine fixed dose~     combination vs. its monocomponents~   "
99889|NCT02259816|"~     Study to investigate the steady state pharmacokinetics of 80 mg telmisartan alone and in~     combination with repeated doses of 10 mg amlodipine~   "
99890|NCT02259803|"~     Study to investigate the relative bioavailability of fixed-dose combination tablet vs.~      mono-components of telmisartan and amlodipine~   "
99891|NCT02259790|"~     Study to investigate the relative bioavailability of fixed-dose combination tablet vs.~      mono-components of telmisartan and amlodipine~   "
99892|NCT02259777|"~     Study to investigate the effect of food intake on the bioavailability of a fixed dose~     combination of 80 mg telmisartan / 10 mg amlodipine following a high fat breakfast~   "
99893|NCT02259764|"~     Study to investigate safety, tolerability and pharmacokinetics of KUC 7483 CL~   "
99894|NCT02259751|"~     Study to investigate pharmacodynamic effects and pharmacokinetics of KUC 7483~   "
99895|NCT02259738|"~     Human urinary kallidinogenase can promote the establishment of collateral circulation in the~     ischemic penumbra due to the stenosis or occlusion of middle cerebral artery and then~     increase the perfusion.~   "
99896|NCT02259725|"~     This phase II trial studies regorafenib in treating patients with neuroendocrine tumors that~     have spread from the primary site (place where it started) to other places in the body.~     Regorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth.~   "
99897|NCT02259712|"~     Introduction: Hipopressive Exercises are included within a method of physiotherapy which was~     created with the purpose of strengthening the deep muscles of the abdomen without damaging~     ligamentous and muscular structures of the perineum, also strengthening the muscles of pelvic~     floor reflexively. Although this technique has been included as treatment and a prevention~     method of pelvic floor dysfunction, there are few studies supporting its benefits. The~     investigators hypotthesis is that the combination of both physical therapy treatments will~     provided the best results for women who suffer pelvic floor dysfunctions.~      Objective: To determine whether Hipopressive Exercises are an option to include in the~     physiotherapy treatment of women suffer at least one pelvic floor dysfunction and whether the~     results reported are comparable to those provided by the classical perineal physiotherapy.~      Subjects and methods: A randomized clinical trial, the examiner being blinded unaware of the~     intervention group to which subjects were assigned. Participants will be randomly assigned to~     three groups:~        1. An experimental group, where the participants will be treated by Hipopressive exercises~          and hygienic and behavioral measures;~        2. Another experimental group where classical perineal physiotherapy will join with~          Hipopressive exercises and hygienic and behavioral advises;~        3. And a third group where will be done classical perineal physiotherapy and hygienic and~          behavioral measures.~      Pre- intervention, immediate post-intervention, 3, 6 and 12 months assessments will be made.~     The selection criteria will be: adult women who present signs and symptoms that indicate a~     pelvic floor dysfunction or have a medical diagnosis to confirm it. All participants must~     understand and sign freely Informed Consent.~      Sample size: Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a bilateral contrast,~     26 subjects were required in each group to detect a difference equal to or greater than 3~     microvolts (Total of 78 subjects). It assumes a standard deviation of 4.8 microvolts and the~     rate of loss to follow up esteem 20% (Magalhães-Resende et al. 2012).~      Data Analysis: A descriptive analysis of all variables was performed. It establish for all~     cases a confidence level of 95% (p <0.05). The effectiveness was assessed by comparing the~     experienced change of the three goups in outcome variables between physicaltherapy~     examinations.~   "
99908|NCT02259569|"~     The purpose of this study is to compare peak airway pressure and gastric insufflation in~     Pressure-Controlled Ventilation or Volume-Controlled Ventilation with I-Gel in pediatric~     patient~   "
99909|NCT02259556|"~     Chimeric antigen receptor-modified T cells (CART) holds great promise for treatment of~     tumors. In this trial, CD30 positive Hodgkin's lymphoma and Non-Hodgkin's lymphoma will be~     treated by CD30-specific CART cells (CART30).~   "
99910|NCT02259543|"~     The aim of this study is to investigate the effects of the application of a citric acid +~     tetracycline gel solution during 90 or 180 seconds compared to no conditioning in the~     outcomes of treatment of Miller's class I or II recession defects by subepithelial connective~     tissue graft.~   "
99898|NCT02259699|"~     The objective of this study is to develop and test a new decision aid -named Patient Centered~     Outcome Aid (PCOA)-that will allow patients to assimilate information and identify trade-offs~     about the impact of IP/IV therapy versus IV-only therapy on their QOL and survival, based on~     their own preferences and personal clinical characteristics, described in terms that are~     meaningful to them. To accomplish this, the investigators will 1)develop the PCOA, a patient-~     and provider-friendly decision aid and 2)test the effectiveness of PCOA through a randomized~     controlled trial (RCT).~      The investigators hypothesize that PCOA will be significantly better than usual care,~     resulting in patients reporting more satisfaction with their treatment decision, less~     decision regret, better quality of life, and more satisfaction with their care compared with~     similar patients not having access to PCOA. If these hypotheses are substantiated, patients~     and providers will have an improved model for communication and decision making, leading to~     better patient outcomes.~   "
99899|NCT02259686|"~     Apelin is an endogenous peptide with physiological actions in the cardiovascular system.~     Apelin can modulate vasomotor tone and is a potent endogenous inotrope. In a series of~     clinical studies, we have shown that apelin causes peripheral and coronary vasodilatation and~     increased cardiac contractility. We wish to study and compare the cardiovascular effects of~     subcutaneous versus intravenous apelin. We specifically wish to determine how different~     methods of apelin administration affect cardiac output and peripheral vascular resistance in~     healthy volunteers~   "
99900|NCT02259673|"~     In this research, the elderly living in nursing homes were selected in two group control and~     intervention.~      Intervention group 3 times a week for 20 minutes during 2 months, fun physical exercises~     (including activities carried out with the use of sports equipment such as beach ball,~     stretch, bird toys, etc).~   "
99901|NCT02259660|"~     The purpose of this research study is to determine if muscle training will improve snoring~     and obstructive sleep apnea. Subjects will receive a sleep study to determine the severity of~     their apnea. After this study, subjects will be randomly assigned to one of two groups. The~     first group will receiving a breathing trainer that may strengthen the muscles used to breath~     in and out. The second group will be receive a sham trainer which looks like the real~     trainer but is not able to produce a strengthening effect. Both groups will complete eight~     weeks of home based (real or sham) training. The sleep study will be repeated and we well~     measure any changes in measures of severity for obstructive sleep apnea.~   "
99902|NCT02259647|"~     60 patients of radiological, biopsy proven advanced HCC (Hepatocellular carcinoma) patient~     will be randomized into two groups. Cases group will receive Sorafenib plus vitamin K and~     control group will receive Sorafenib plus placebo~   "
99903|NCT02259634|"~     This is a 3-year prospective randomized comparative study of the efficacy of patient~     navigation on health education, health related quality of life, healthcare utilization, and~     medical outcomes in formerly incarcerated individuals. Individuals will be randomized to the~     patient-navigator intervention or to a care-as-usual control condition. A total of 300~     recently incarcerated individuals will be enrolled with 150 subjects each in the intervention~     and usual care group.~      The investigators hypothesize that the intervention will improve health education, health~     related quality of life, adherence to clinical appointments, glycemic/blood pressure control,~     and virologic suppression in HIV-infected. The results of this study will demonstrate~     interventions to eliminate health disparities in a highly marginalized group going through~     the transitional phase of re-entry into the community.~   "
99904|NCT02259621|"~     The proposed study will evaluate the safety and feasibility of preoperative administration~     nivolumab +/- ipilimumab in patients with high-risk resectable NSCLC, and will facilitate a~     comprehensive exploratory characterization of the tumor immune milieu and circulating immune~     cells and soluble factors in these patients. Data obtained in this study will provide~     valuable information for planning further prospective clinical trials of anti-PD-1 and other~     immunotherapies in NSCLC, both in the peri-operative and advanced disease setting.~   "
99905|NCT02259608|"~     Rationale: The live attenuated Bacillus Calmette-Guerin (BCG) vaccine protects against~     extrapulmonary infection with Mycobacterium tuberculosis and leprosy. It has been shown that~     vaccination with BCG also leads to nonspecific protective effects, e.g. reduced infant~     mortality as a result of less severe infections, stimulation of the immune system in patients~     with bladder cancer and higher cytokine production upon restimulation of macrophages with~     non-related infectious pathogens in vitro. However, because the live attenuated BCG vaccine~     cannot be used in immune compromised hosts, the investigators would like to determine whether~     similar protective non-specific effects can be induced by γ-irradiated BCG.~      Objective: To determine whether vaccination with γ-irradiated BCG results in a higher~     cytokine response by monocytes upon restimulation in vitro with infectious pathogens,~     compared to monocytes before the vaccination.~      Study design: Explorative intervention trial. Study population: Healthy volunteers, 18 - 55~     years old. Intervention: Healthy volunteers will be vaccinated with γ-irradiated BCG vaccine.~      Main study parameters/endpoints: Blood will be drawn before and at two different time points~     after vaccination with BCG to perform restimulation of isolated cells in vitro and compare~     cytokine production.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: There is no known direct benefit for the volunteers to participate in the trial.~     The risks are negligible. BCG vaccination can cause pain and scarring at the site of~     injection, just as fever and headache. Local hematoma formation can occur at the site of the~     blood drawing. This will be minimized by the blood collection by experienced persons.~   "
99906|NCT02259595|"~     This study is a single-center, randomized, placebo-controlled, double-blind, single ascending~     dose escalation study to determine the safety, tolerability, and PK profile of oral~     administration of HPN-07 in single doses to approximately 32 healthy male and female subjects~     between 18 and 55 years of age.~      Subjects will receive single oral doses of the study drug. The primary endpoint of this trial~     is to establish the safety and tolerability of HPN-07 and HPN-07 plus N-acetylcysteine (NAC).~   "
99907|NCT02259582|"~     A randomized, double-blind, 3-arm (1:1:1) study in subjects with first-line Stage IV~     non-squamous NSCLC. The purpose is to test the efficacy and safety of demcizumab, when given~     in combination with carboplatin and pemetrexed compared to placebo. The administration of~     carboplatin and pemetrexed is a standard treatment for patients with non-squamous non-small~     cell lung cancer.~   "
99912|NCT02259517|"~     Children with Attention-Deficit/Hyperactivity Disorder (ADHD) are typically treated with two~     types of medications with differing mechanisms of action: stimulants and non-stimulants. The~     stimulant Vyvanse (lisdexamfetamine, LDX), and the non-stimulant Intuniv (extended-release~     guanfacine, GXR), are both FDA approved treatment for ADHD. Clinical trials have shown that~     both medications are effective in reducing ADHD symptoms, although the neurobiological~     mechanisms by which Vyvanse and Intuniv produce these effects remain unknown. The aim of this~     study is to examine the mechanisms by which LDX and GXR reduce symptoms in patients with~     ADHD. MRI scanning will be used to identify treatment-related changes in brain structure and~     function.~   "
99913|NCT02259504|"~     This is a prospective, single-arm, multi-center post-marketing Study. The Study will commence~     as a single phase, with an optional second phase to follow at the discretion of the sponsor.~     Up to 300 eligible Subjects with small (< 4.9 mm) intracranial aneurysms, who consent to~     Study participation, will be treated in Phase 1 with MicroVention HyperSoft® 3D and~     HyperSoft® Helical coils with or without balloon remodeling or stent assistance at the~     discretion of the treating physician. The operator, at his/her discretion, may choose to~     frame the aneurysm with HyperSoft® 3D or any other bare metal coil but must finish the~     remainder of the aneurysm with HyperSoft® 3D and/or HyperSoft® Helical coils. At the~     discretion of the sponsor, additional patients, up to 300 patients total for the overall~     Study, with eligible aneurysms will be enrolled into Phase 2. In Phase 2, the aneurysm must~     be framed with a HydroFrame® or HydroSoft® 3D coil and filled/finished primarily with~     hydrogel coils. The intent to treat is to frame, fill and finish with all hydrogel coils.~     However, at the discretion of the treating physician, a bare platinum coil may be used to~     fill or finish, as long as a minimum of 50% (in total coil length) of hydrogel coils are~     used. Data will be collected on immediate and post-treatment angiographic occlusion rates~     (RRGS), new peri-procedural imaging-confirmed hemorrhage or ischemic stroke, neurological~     morbidity and mortality rates, recurrence rates, bleeding rates, retreatment rates, serious~     adverse events, >150 day angiographic occlusion rates (RRGS) and occlusion status. This will~     serve to establish the acute and sustained efficacy of EVT of small intracranial aneurysms~     with the specified microcoils, aided by balloon and/or stent remodeling where appropriate.~   "
99914|NCT02259491|"~     Since antiquity, honey has been recognized for its healing properties. Literature about the~     use of medicinal honey for wound care dates back centuries with recent data suggesting its~     use in patients suffering from burns or pressure ulcers. Research has shown Manuka honey~     (Leptospermum scoparium) to have significant immune benefits and the ability to influence all~     phases of wound healing: inflammation, proliferation and remodeling. In addition, numerous~     clinical studies have identified positive benefits for wound healing. However, there is a~     lack of prospective, randomized controlled data on the use of honey as a medicinal agent in~     local wound care and scar healing.~      In order to better understand Manuka Honey's ability to aid in healing, the investigators are~     conducting a randomized, controlled, single-blinded study of patients undergoing~     reconstructive surgery. This project uses split thickness skin graft and free tissue transfer~     donor sites as standard wound models to compare the effects of Manuka Honey versus standard~     wound care therapies. Through the use of standard wound model and objective measurement~     tools, the investigators hope to better elucidate any benefits of this novel wound care~     'technology.'~   "
99915|NCT02259478|"~     Patients at high risk of IVIG-associated hemolysis (defined as receipt of a 28-day cumulative~     dose of ≥ 2 g/kg, adjusted for ideal body weight, and non-O blood group) will be~     prospectively monitored using a standardized protocol for signs of hemolysis, and will be~     undergo additional testing for variables that have been hypothesized to increase the risk of~     hemolysis. The goal of the study is to define the incidence and dynamics of IVIG-mediated~     hemolysis and identify patient and product-related factors that may predict which patients~     are especially at risk.~   "
99916|NCT02259465|"~     Some carbohydrates, complex sugars, which are found in grains, fruit and vegetables, cannot~     be digested by humans. When eaten they pass through the small bowel to the large bowel, or~     colon. Some bacteria that live in the colon are able to digest these carbohydrates, and use~     them as an energy source. This releases energy that humans can absorb, and may have other~     effects on health as well. The process also releases gases such as hydrogen and methane into~     the colon, which will eventually be released as flatulence.~      There is some evidence in animals, and humans, that changing the carbohydrate content of the~     diet may increase the numbers of bacteria in the colon that can use this energy source.~     Recent work has looked at how changes in colon bacteria and carbohydrate in the diet affect~     transit, the speed at which food and stool moves through the stomach and bowels.~      This undergraduate project will use techniques in Magnetic Resonance Imaging developed in~     Nottingham to investigate how a prolonged change in dietary carbohydrate might affect speed~     of transit through the bowel and gas production in the colon, and whether there is any immune~     reaction to the carbohydrate from the bowel wall.~   "
99917|NCT02259452|"~     The purpose of the study is to assess the time, dose dependence, and fraction-size dependence~     of radiation (RT)-induced changes in regional lung and heart perfusion/function/structure~     following thoracic RT delivered using newer IMRT/conformal/radiosurgery techniques. The PI~     hopes to develop models to better relate and predict RT-induced changes in regional lung and~     heart perfusion/function/structure with changes in global cardiopulmonary function. Patients~     will undergo pre- and serial post-RT lung and heart assessments to better understand~     RT-induced regional heart/lung changes.~   "
99918|NCT02259439|"~     Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) represent a leading~     cause of morbidity and mortality.Patients admitted to hospital present higher mortality~     rates.The investigators lack the specific tools that allow us to easily classify and~     establish the individual prognosis for each patient during their hospitalization.~      Rational of the study:to identify the predictive factors for hospital mortality in critically~     ill patients admitted to hospital due to an episode of COPD exacerbation.~   "
99995|NCT02258438|"~     The investigators propose in this project to determine the effect of 3 days of frequent~     interruption of prolonged sitting on metabolic health in healthy overweight sedentary adults~     (n=24), as compared to 3 days including a single long bout of isocaloric exercise or a~     control condition where subjects do not exercise but are subjected to prolonged sitting. The~     investigators believe that this proposed project will provide an initial evidence base for~     the health benefits of breaking up prolonged sitting with short bursts of moderate-intensity~     activity, like walking.~   "
99919|NCT02259426|"~     Primaquine (PQ) is currently the only available drug that can clear the mature transmission~     stages of P. falciparum parasites. PQ was previously shown to clear gametocytes that persist~     after artemisinin-combination therapy. A major caveat to the use of primaquine in mass~     adminsitrations for the reduction of malaria transmission is that metabolism of the drug in~     individuals with glucose-6 phosphate dehydrogenase (G6PD) deficiency can lead to transient~     haemolysis. The haemolytic side effect of PQ is dose-related. Haemolysis is more commonly~     observed after prolonged PQ treatment but has also been observed in African populations~     following a single dose of PQ. This haemolysis was self-limiting, largely restricted to G6PD~     deficient individuals and did not lead to clinical symptoms. Nevertheless, any drug-induced~     haemolysis is reason for concern and the World Health Organization has therefore reduced the~     recommended dose of single low dose primaquine from 0.75mg/kg to 0.25mg/kg. This dosage is~     deemed safe without prior G6PD or Hb screening. However, there is limited direct evidence on~     the extent to which this dosage of PQ prevents malaria transmission to mosquitoes.~      In the current study, the investigators will assess the efficacy of DP in combination with~     low-dose PQ to prevent onward malaria transmission. The investigators will perform the~     investigators study in individuals aged 5-15 years who are carry microscopically detectable~     densities of P. falciparum gametocytes. This age group is chosen because asexual parasite~     carriage and gametocyte carriage are common in this age group. All enrolled individuals will~     receive a full three-day course of DP, and will be randomized to receive a dose of primaquine~     or placebo with their third dose. Efficacy will be determined based on gametocyte carriage~     during follow-up, measured by molecular methods. For all individuals, the effect of treatment~     on infectivity to mosquitoes will be assessed by membrane feeding assays at two time points.~   "
99920|NCT02259413|"~     The purpose of this study is to determine whether participation in a 12 week exercise~     rehabilitation program is effective at reducing symptom burden and improving quality of life~     in individuals receiving chronic hemodialysis.~   "
99921|NCT02259400|"~     The purpose of this study is to determine whether two different strategies of Non Invasive~     Ventilation (NIV) have different effect on length and failure of NIV support in preterm~     infants with respiratory distress syndrome (RDS).~   "
99922|NCT02259387|"~     The overall objective of this proposal is to better define the relationship between perceived~     stress, hair cortisol, and migraine in adolescents. This will be done by creating 2 arms of~     the study: those with migraines (cases) and those without migraines or headaches (controls).~     Each arm will answer several of the same questionnaires and have hair cortisol samples taken~     multiple times over the course of 12 weeks.~   "
99923|NCT02259374|"~     TAP block performed under ultrasound guidance is used as part of multimodal analgesia to~     relieve pain after abdominal surgery in our hospital. Choices of local anaesthetic used~     include bupivacaine and ropivacaine. Local anaesthetic works by inhibiting nerve transmission~     of pain from the site of tissue injury. An important component of the pain experienced by~     patients after abdominal surgery derives from the abdominal wall incision. The abdominal wall~     sensory afferents course through the transversus abdominis (neurofascial) plane superficial~     to the transversus abdominis muscle. Single shot TAP block has been shown to provide pain~     relief of up to 24h in surgeries involving pfannenstiel incisions, hence a study period of~     24h is chosen in patients undergoing hysterectomy.~      This study was designed to test the hypothesis that the TAP block, as part of a multimodal~     analgesic regimen, even at a lower concentration, would provide effective analgesia in the~     first 24 h after hysterectomy, in comparison to a higher concentration of 0.4% ropivacaine.~   "
99924|NCT02259361|"~     This study evaluates the effects of sustained-release oral dalfampridine in the treatment of~     upper limb deficits in people with multiple sclerosis (MS). In this double-blind randomized~     pilot study half of participants will dalfampridine, while the other half will receive a~     placebo.~   "
99925|NCT02259348|"~     This pilot phase II trial studies how well a new reduced intensity conditioning regimen that~     includes haploidentical donor NK cells followed by the infusion of selectively T-cell~     depleted progenitor cell grafts work in treating younger patients with hematologic~     malignancies that have returned after or did not respond to treatment with a prior~     transplant. Giving chemotherapy and natural killer cells before a donor progenitor cell~     transplant may help stop the growth of cells in the bone marrow, including normal~     blood-forming cells (progenitor cells) and cancer cells. It may also stop the patient's~     immune system from rejecting the donor's cells. When the healthy progenitor cells from a~     related donor are infused into the patient they make red blood cells, white blood cells, and~     platelets. Sometimes the transplanted cells from a donor can make an immune response against~     the body's normal cells (called graft-versus-host disease). Removing specific T cells from~     the donor cells before the transplant may prevent this.~   "
99926|NCT02259335|"~     Weaning from invasive mechanical ventilation is one of the major clinical problem especially~     ion those patients with a pre-existing chronic respiratory disease and chronic hypercpania.~      The aim of this pilot feasibility and safety trial is to assess the possibility of shorten~     the duration of mechanical ventilation using a device able to remove CO2 and theoretically~     able to allow therefore the praecox extubation~   "
99927|NCT02259322|"~     This study will test the effectiveness of two distinct behavioral treatments for loss of~     control eating following bariatric surgery:~        1. Behavioral Weight Loss Treatment~        2. Cognitive Behavioral Therapy~      These treatments will be compared to Standard-of-Care.~   "
99928|NCT02259309|"~     The present study is designed to address the null hypothesis that there is no difference in~     the local and systemic immunomodulatory effects of buccally or vaginally administered~     misoprostol in healthy, reproductive-age women.~   "
99929|NCT02259296|"~     The timing for arteriovenous fistula (AVF) creation and its effect on target organs in~     patients with chronic renal failure will be investigated by multicenter prospective cohort.~     Lower estimated glomerular filtration rate (eGFR) patients (eGFR<10ml/min 1.73m2 for patients~     without diabetic kidney disease, and eGFR<15ml/min 1.73m2 for diabetic kidney disease) and~     higher eGFR patients (eGFR 10-15ml/min 1.73m2 for patients without diabetic kidney disease,~     and eGFR 15-20ml/min 1.73m2 for diabetic kidney disease) will be proposed to undertake AVF~     creation. Maturation rate and time of AVF will be followed up in 3 months; primary and~     secondary patency rate of AVF, AVF construction on cardiac structure, function,~     encephalopathy, cerebral vascular lesions and cognitive function will be followed up in the~     next 2 years. This multicenter will provide evidence to develop guideline of timing for AVF~     creation~   "
100041|NCT02257814|"~     The purpose of this study was to deepen the evidence base for interventions that support the~     social-emotional skills that underlie children's engagement and attention to learning tasks~     by schools (learning behaviors) and their social interactions with teachers and peers (social~     behaviors). The study tested three theoretically-distinct approaches to enhancing children's~     social-emotional development, along with a comprehensive coaching and training model, on a~     large scale within the Head Start system.~   "
99930|NCT02259283|"~     Treatment options for achalasia include endoscopic dilations and surgical myotomy. Recently~     the POEM (Per oral endoscopic myotoymy) technique has been described. Patients undergo~     myotomy under endoscopic control. It has advantage over endoscopic dilation since myotomy is~     performed, and has advantage over surgery because it is performed endoscopically, thus is~     less invasive. One potential disadvantage in respect to surgery may be that it may determine~     higher rates of post-operative reflux. The purpose of this study is to prospectively assess~     the feasibility of PEOM in our Center with the new hybrid knife, and clinical results at 1, 3~     and 12 months.~      This is a prospective, phase II study. Ten patients (age 18-75 years old) with diagnosis of~     achalasia, without megaesophagus or colonic esophagus, will be included for the POEM~     procedure.~      This study will last about 2 years. The aim is the feasibility, security and success rate of~     POEM for achalasia. Patients will be followed for at least one year.~   "
99931|NCT02259270|"~     Acid suppressive therapy (AST) is used in a variety of indications in prevention and~     treatment of gastric acid related disorders. In recent years, an increase in the use of acid~     suppressive therapy has been documented. It has generally been accepted that these agents are~     effective and safe. However, very recently, reports describing hypomagnesaemia, hypocalcemia,~     vitamin B12 deficiency and enteric infections, were published.~      The goal of this study is to evaluate 1) how many cases of long-term ambulatory treatment~     with AST are initiated during hospital stay (= ASTRA-1), and 2) assess the appropriateness of~     initiation of AST and the appropriateness of continuation of AST at discharge in a subset of~     the hospitalized patient population (= ASTRA-2). Finally, the pharmacoeconomic impact of~     inappropriate AST during hospitalisation will be calculated from these data.~      The primary endpoint is defined as the number of patients on long-term ambulatory AST after~     initiation in the hospital. Secondary endpoints are the appropriateness check of AST both at~     the level of initiation during hospitalization and at discharge (appropriate continuation);~     also the impact on the hospital budget (lump sum budget) will be calculated, and potential~     cost avoidance for long-term ambulatory inappropriate AST will be estimated from a healthcare~     payer perspective for a period of 1, 3, 6 and 12 months.~   "
99932|NCT02259257|"~     Contrast enhanced 3D/4D (3 dimension/4 dimension) ultrasound (CEUS) provides visualization of~     the dynamic vascular features of the plaques, in a unique spatial format using three~     orthogonal planes and angiogram-like images. Therefore, the observer can utilize the entire~     vascular system in a volumetric manner (3D). The rotation of the intra-plaque neovasculature~     as viewed in various angles provides a realistic representation that is more easily~     appreciated. Inter-observer variability for individual plaques has been assessed and~     inter-observer variability and inter-scan variability (the analysis of multiple images from~     single patients in longitudinal studies) were dependent on plaque size, with larger plaques~     showing lower variability. Therefore, the proposed 3D/4D vs. 2D CEUS imaging of the carotid~     plaque will provide added value for the depiction of the and quantification of intra-plaque~     blood vessel density by providing a true volumetric viewing area. This data will be~     correlated to the subsequent surgical specimens. The goal of the protocol is to investigate~     the correlation of intra-plaque blood vessel density and hemorrhage to 3D/4D CEUS vasa~     vasorum using quantitative software analyses. The histology methods used for quantification~     of hemorrhage and vessel density analyses.~   "
99933|NCT02259244|"~     The purpose of this study is to evaluate the combined effect of physical activity and~     adherence to Mediterranean diet or Hypolipemic Reduction diet on parameters of oxidative~     stress in obese patients enrolled in the weight management reduction program.~   "
99934|NCT02259231|"~     Malignant melanoma is a leading cause of death from cutaneous malignancies, accounting for~     approximately three-fourths of all skin cancer deaths. For metastatic or unresectable~     melanomas, standard treatment options include immune checkpoint inhibitors (e.g., ipilimumab~     and nivolumab) and other therapies, however, approved therapies are rarely curative.~      It is now well accepted that tumors are able to evade detection and eradication by the immune~     system, even though many tumor types, particularly melanoma, are capable of eliciting a~     strong immune response (Swann, 2007). Substantial mechanistic work in recent years has~     revealed the key role of myeloid-derived suppressor cells (MDSCs) in masking cancer cells~     from the immune system, promoting both tumor progression and resistance to cancer~     immunotherapy. The immune-suppressive effect of MDSCs is dependent on the production of~     reactive oxygen species (ROS) and reactive nitrogen species (RNS). High levels of these~     reactive molecules and their by-products, such as nitrotyrosine, have been correlated with~     poor clinical outcomes in melanoma. Currently available melanoma therapies do not target~     MDSCs.~      In animals, RTA 408 significantly reduces tumor nitrotyrosine burden, inhibits the activity~     of MDSCs, and augments T-cell anticancer activity at relevant doses. Thus, through inhibition~     of MDSC activity and suppression of tumor ROS/RNS, RTA 408 may work in combination with~     T-cell-activating therapeutics such as ipilimumab to enhance the natural immune anticancer~     response. RTA 408 also has direct anticancer effects via inhibition of NF-kappa B. Chronic~     activation of NF-kappa B is associated with tumor progression, metastasis, and resistance to~     therapy.~      This proposed study is designed to assess the safety, efficacy, pharmacodynamics, and~     pharmacokinetics of omaveloxolone (RTA 408) in combination with ipilimumab or nivolumab in~     patients with unresectable or metastatic melanoma.~      In this open-label, multicenter, dose-escalation, Phase 1b/2 study, patients who qualify will~     receive omaveloxolone (RTA 408) at the assigned dose level in combination with ipilimumab or~     nivolumab. Patients will receive omaveloxolone (RTA 408) orally once daily for 1 week prior~     to initiation of ipilimumab or nivolumab. For patients treated with ipilimumab , the run-in~     period will be followed by omaveloxolone (RTA 408) orally once daily in combination with~     ipilimumab administered at Weeks 1, 4, 7, and 10. After Week 10, patients will receive~     maintenance treatment with omaveloxolone (RTA 408) alone once daily. For patients treated~     with nivolumab, the run-in period will be followed by omaveloxolone (RTA 408) orally once~     daily in combination with nivolumab administered approximately every two weeks as clinically~     indicated. Each patient will continue at the assigned omaveloxolone (RTA 408) dose level~     until disease progression occurs, toxicity requiring discontinuation from study drug (i.e.,~     RTA 408) is experienced, the patient has completed approximately 72 weeks of treatment, the~     patient is discontinued from the study drug for another reason, or the patient withdraws~     consent. Patients will return 4 weeks after omaveloxolone (RTA 408) treatment completion for~     a follow-up visit.~      The starting omaveloxolone (RTA 408) dose level for the first dose-escalation cohort in this~     study has been selected based on available safety and pharmacodynamic data from a Phase 1~     study of RTA 408 (NCT02029729). Subsequent cohorts will be enrolled at dose levels based on~     available safety and PD data from this study, but they will not be greater than 2-fold above~     the prior dose level.~      Phase 1b (dose-escalation): In the phase 1b/2 portion of this study, 12 patients will be~     enrolled in each dose cohort, with six patients administered omaveloxolone (RTA 408) plus~     ipilimumab and the remaining six administered rTA 408 plus nivolumab. Subsequent cohorts will~     assess escalating the doses of omaveloxolone (RTA 408) administered in combination with~     ipilimumab or nivolumab. Dose escalation decisions will be based on ongoing review of all~     available safety information for enrolled patients.~      Phase 2: The Phase 2 portion of the study may include separate expansion cohorts consisting~     of patients treated with either of the combination therapies. Each expansion cohort will~     include an additional 24 patients enrolled at the selected Phase 2 dose level to achieve a~     total of 30 patients at that omaveloxolone (RTA 408) dose in combination with ipilimumab or~     nivolumab.~   "
99935|NCT02259218|"~     This research trial studies metabolomic and other molecular profiling to identify predictive~     biomarkers for radiation toxicity and survival in patients with lung or brain cancers~     receiving radiation therapy. Studying samples of blood, urine, and tissue from patients with~     lung or brain cancer in the laboratory may help doctors identify and learn more about~     biomarkers related to cancer and predict which patients are at higher risk for developing~     radiation side effects and how well patients will respond to radiation treatment.~   "
99936|NCT02259205|"~     This study evaluates the effectiveness of a yogurt enriched with bioactive lipids extracted~     from olive mill waste in platelet aggregation and other inflammatory and oxidative stress~     markers. The study will include three groups: the intervention group will receive the~     enriched yogurt while the other two groups will serve as controls (plain yogurt and no yogurt~     consumption).~   "
99937|NCT02259192|"~     The purpose of this investigation is to determine the safety and preliminary efficacy of~     implanting a cochlear implant (CI) in the profoundly deaf ear of an adult with one normal~     hearing (NH) ear (termed single-sided deaf person, or SSD). The potential subjects will~     have been deafened post-lingually, thus, at one point the now deafened ear did conduct sound~     from the periphery. The MED-EL CI system will be implanted in ten (10) SSD patients.The~     long-term goal of this research program is to determine whether the CI, in combination with~     the NH ear, may provide improved localization ability and better speech understanding in~     noise, relative to performance before cochlear implantation (i.e., with the NH ear alone). A~     secondary long-term goal is to determine whether CI stimulation may reduce tinnitus severity,~     compared to tinnitus experienced prior to cochlear implantation or when the CI is turned off,~     after implantation.~   "
99938|NCT02259179|"~     This is a Phase 1, open-label, randomized, single-dose, 2-way crossover study in healthy~     adult subjects to assess the bioequivalence of naltrexone SR/bupropion SR combination~     trilayer tablets prepared at two different manufacturing sites. The pharmacokinetics of the~     two drug products will be evaluated separately in the fed and fasted state.~   "
99939|NCT02259166|"~     The purpose of this study is to assess if the Enhanced Homestead Food Production Plus (EHFP+)~     Program implemented by HKI in Mwanza, Tanzania, enhances uptake of Micronutrient Powder (MNP)~     supplementation in children, helps maintaining reduced anemia levels among children after a~     blanket provision of MNP, and has an impact on child growth, infant and young child feeding~     (IYCF) practices, maternal knowledge related to health, nutrition, WASH and malaria~     prevention, food security and women's empowerment.~   "
100042|NCT02257801|"~     The purpose of this study is to study effects of a four months lutein supplementation (in~     form of a lutein fortified nutritional beverage) on general learning and memory performance~     as well as on acute stress-induced changes in learning and memory performance in chronically~     stressed males and females using 2 different lutein doses in comparison to a placebo.~   "
99940|NCT02259153|"~     The objective of the study is to assess the effect of two diets with different fat~     composition on cholesterol metabolism. The study was a randomized cross-over trial where~     volunteers follow two study periods with different types of meat (lean and fat red meat)~     separately by a ten days wash-out period. At the beginning of the study and after the study~     periods the following parameters are determined: anthropometric (weight, waist, circumference~     and body mass index), blood pressure, dietary (72-hours dietary registry) and exercise~     assessments and biochemical analysis (total cholesterol, triglycerides, HDL cholesterol, LDL~     cholesterol, apolipoprotein A1, apolipoprotein B, iron, transferring, ferritin, uric acid,~     glucose, HbA1c and insulin). Serum concentration of non cholesterol sterols (sitosterol,~     campesterol, stigmasterol, desmosterol and lanosterol) and oxysterols~     (24S-hydroxycholesterol, 27-hydroxycholesterol and 7α-hydroxycholestenone) were measured by~     High Performance Liquid Chromatography tandem Mass Spectrometry in these subjects throughout~     along the study in order to demonstrate the effect of different red meat on the hepatic~     metabolism of cholesterol.~   "
99941|NCT02259140|"~     This randomized controlled trial will compare proximal femoral resection-interposition~     arthroplasty to proximal femoral resection with subtrochanteric valgus osteotomy for the~     treatment of painful irreducible hip dislocation in patients with cerebral palsy. The primary~     outcome is quality of life and care giver burden measured by The Caregiver Priorities and~     Child Health Index of Life with Disabilities (CPCHILD) score at one year. Secondary outcomes~     will include pain (NCCPC-R, PROMIS pain intensity and PROMIS pain interference), function~     (mobility questions), complications and surgical parameters such as OR time and fluoroscopy~     time. A cost-effectiveness analysis will follow completion of the randomized controlled trial~     (RCT). The authors hypothesize that mean CPCHILD scores (measured at 1 year) will be~     significantly higher following the Subtrochanteric Valgus Osteotomy technique compared to~     Proximal Femoral Resection-Interposition Arthroplasty technique. Furthermore, the Proximal~     Femoral Resection-Interposition Arthroplasty technique will have a shorter length of hospital~     stay, shorter fluoroscopy and OR times and the Subtrochanteric Valgus Osteotomy will have~     longer sitting tolerance, less pain, smaller burden for caregivers, better health, and higher~     quality of life. Additionally the authors hypothesize that Subtrochanteric Valgus Osteotomy~     will be more expensive than Proximal Femoral Resection-Interposition Arthroplasty, due to the~     cost of the plate, longer operative time, longer length of stay, and blood loss, but~     Subtrochanteric Valgus Osteotomy will be preferred by patients due to less pain and better~     functional and quality of life outcomes.The results of this study are expected to improve~     outcomes for children with cerebral palsy with painful irreducible dislocated hips.~   "
99942|NCT02259127|"~     A new anti-HIV medicine (Dolutegravir) combined with 2 currently used anti-HIV medicines is~     non-inferior to the standard combination of medicines used in terms of efficacy and better in~     terms of toxicity.~   "
99943|NCT02259114|"~     Open-label, phase I, non-randomized, multicentric study of single-agent OTX105/MK-8628~     administered according to two distinct regimens to participants with selected advanced~     tumors.~      The study will be performed in two parts.~      Dose Escalation Part:~      This step is designed to determine the maximum tolerated dose (MTD) in each of the two~     regimens, which will be evaluated in parallel. Participants will receive oral OTX105/MK-8628~     according to:~      Continuous Dosing Regimen: continuous, once daily for 21 consecutive days (21-day cycles).~      OR Days 1-7 Dosing Regimen: once daily on Days 1 to 7, repeated every 3 weeks (21-day cycles;~     1 week ON/2 weeks OFF).~      Participants will be sequentially assigned to Continuous Dosing Regimen or Days 1-7 Dosing~     Regimen according to the next available place and receive OTX105/MK-8628 at escalating doses~     levels (DL). Cohorts of 3 participants will be treated, and an additional 3 participants will~     be treated at the first indication of dose-limiting toxicity (DLT). MTD assessment will be~     based on the tolerability observed during the first 21 days of treatment.~      Expansion Part:~      The efficacy of OTX105/MK-8628 in each of the five indications (i.e., Bromodomain-Nuclear~     Protein in Testis [BRD-NUT] midline carcinoma, triple negative breast cancer [TNBC],~     non-small cell lung cancer [NSCLC] harboring a rearrangement Anaplastic Lymphoma Kinase [ALK]~     gene/fusion protein or Kirsten Ras [KRAS] mutation, castrate-resistant prostate cancer, and~     pancreatic ductal carcinoma) will be assessed in terms of response (Response Evaluation~     Criteria in Solid Tumors v1.1 [RECIST v1.1] or Prostate Cancer Clinical Trials Working Group~     2 [PCWG2]) using a selected regimen.~   "
99944|NCT02259101|"~     The proposed study will consist of a randomized controlled trial (RCT) comparing a known~     efficacious treatment for insomnia (CBT-I) to a sleep hygiene (SH) comparison condition.~   "
99945|NCT02259088|"~     Study of efficacy and safety of 0.5 mg ranibizumab in Chinese patients with diabetic macular~     edema (DME)~   "
99946|NCT02259075|"~     Chronic migraine is in many cases a most disabling condition. Chronic migraine is defined as~     headaches for at least 15 days per month, of which 8 days have typical migraine features. In~     many cases, oral drug treatment has little effect.~      The parasympathetic nervous system acting through the sphenopalatine ganglion may be involved~     in several primary headaches, including migraine, by facilitating release of inflammatory~     substances in cerebral vessels. Botulinum toxin type A (BTA) inhibits excretion of~     acetylcholine resulting in blocking of nerve signals in the sphenopalatine ganglion.~      The purpose of the present study is to evaluate a new technique with injection of BTA using~     an minimal invasive image guided procedure, for blocking of the sphenopalatine ganglion. The~     goal is to relieve the migraine symptoms and develop an alternate treatment for cases where~     oral drug treatments fail.~      The main objective of the project is to determine the safety of this method of BTA injection~     in the area of the sphenopalatine ganglion by detecting adverse events. Secondary objectives~     are to measure changes in headache attack parameters with this novel method.~   "
100006|NCT02258295|"~     This proposal is a prospective, randomized, double-blinded study to evaluate the efficacy of~     hyaluronic acid (HA) injections for chronic lateral epicondylitis (LE). HA has traditionally~     been used to treat knee osteoarthritis. There are a small number of studies in the literature~     that suggest that HA injections can be very effective for tendinosis. Although LE has been~     studied with literally hundreds of articles published, very little treatment has proven to be~     efficacious. This study will investigate the effectiveness of hyaluronate in treatment of~     chronic LE. This will include a two arm study with one formulation of HA tested against~     saline injections as the control.~   "
139376|NCT01743001|"~     Clinical study to assess the efficacy, safety, and tolerability of macitentan in subjects~     with Eisenmenger Syndrome.~   "
99947|NCT02259062|"~     Stroke is the biggest cause of disability in older adults. Early poststroke rehabilitation~     focuses primarily on physical disability and activities of daily living. By contrast,~     relatively little research attention has been paid to the potential for cognitive~     rehabilitation and mood enhancing interventions in the early stages after stroke. Low mood~     and cognitive difficulties with attention and memory are common post stroke leading to poorer~     recovery, emotional wellbeing and quality of life yet accessible and effective therapies are~     lacking.~      Engagement in leisure activities may enhance recovery after stroke but participation in~     leisure activities is reduced following stroke. Music listening is a low cost and accessible~     leisure activity that has been suggested to improve mood and cognition poststroke. The~     investigators speculate that music listening may enhance control of attention in a similar~     way to mindfulness interventions, that have been demonstrated to be beneficial in the~     treatment of mood disorders. The investigators propose that adding a brief mindfulness~     intervention to music listening might enhance the effect on control of attention, with~     positive effects on cognition and mood poststroke but the feasibility and acceptability of~     this intervention needs to be evaluated before attempting a further trial assessing the~     effectiveness of this intervention. The investigators aim to recruit 100 patients within two~     weeks poststroke.~      Participants will be randomly assigned to receive an 8 week music listening alone, music~     listening with brief mindfulness or audiobook listening intervention alongside treatment as~     usual. Neuropsychological assessment of cognition and mood will be performed at baseline, 3~     months, and 6 months poststroke In addition, participants will be interviewed about their~     experience of engaging in the interventions.~   "
99948|NCT02259049|"~     The investigators are observing the effects 2,000 mg of L-tyrosine will have on 24 hour blood~     pressure fluctuations in individuals with Parkinson's disease.~   "
99949|NCT02259036|"~     The primary goal of this research study is to develop an interactive smartphone app that~     could be used to increase the effectiveness of talk therapy such as cognitive behavioral~     therapy (CBT) for child anxiety.~   "
99950|NCT02259023|"~     Purpose:~      The objective of this study is to determine the effect different sources and forms of~     discretionary foods have on stress perception in healthy adults in a free living, real world~     setting.~      Rationale:~      The rationale for conducting this study is to test the effects of sugar-sweetened beverages~     and grain-based desserts have on perceived health and stress perception, since the evidence~     for this topic is limited.~   "
99951|NCT02259010|"~     This study will assess the effect of multi-dose administration of itraconazole on the~     single-dose pharmacokinetics (PK) of alisertib.~   "
99952|NCT02258997|"~     The investigators propose that patients with HbSβ-thalassemia have lower levels of hepcidin~     and higher levels of GDF-15 than HbSS patients during the non-crisis, steady states. In~     addition, the investigators propose that when controlled for RBC transfusion, patients with~     HbSβ-thalassemia will have higher levels of storage iron (based on serum ferritin).~      Participants: Total number of subjects is 42 - 21 subjects with HbSS, and 21 subjects with~     HbSβ-thalassemia ).~      Procedures (methods): Eligible subjects with documented SCD (HbSS, HbS-β 0-thalassemia or~     HbS-β+-thalassemia) followed at the University of North Carolina (UNC) Comprehensive Sickle~     Cell Program will be evaluated in this single-center, prospective, cross-sectional study. The~     patients will be screened for eligibility at the time of a routine sickle cell clinic visit.~     Patients' data will be obtained in person at the time of evaluation and through review of~     their medical records. Investigators will obtain information on SCD-related clinical~     complications and obtain an estimate of the number of lifetime RBC transfusions. Blood~     samples will be obtained for laboratory tests. Plasma samples for hepcidin, growth~     differentiation factor 15 (GDF -15), and high-sensitivity CRP will be stored at -80 degrees~     Celsius until analysis. Other routine laboratory studies including complete blood count (CBC)~     with differential and reticulocyte count, serum iron profile and ferritin, and liver function~     tests will be performed at the clinical laboratories of UNC Hospitals.The subjects will have~     30 ml. of blood drawn for this research study. Females of child bearing potential will have a~     urine pregnancy test at the time of the study.~   "
99953|NCT02258984|"~     The purpose of this study is to evaluate the impact that the Venus 1000 non-invasive CVP~     system has on the management of emergency department (ED) patients with fluid sensitive~     conditions.~   "
99954|NCT02258971|"~     Primary objectives: To determine the basic pharmacokinetics of BEA 2180 BR, its metabolites~     CD 1975 ZW and CD 1976 ZW and radioactivity including excretion mass balance, excretion~     pathways and metabolism following the oral and intravenous administration of [14C] BEA 2180~     BR~      Secondary objectives: To determine safety and tolerability following single dose oral and iv~     administration of BEA 2180 BR in healthy male volunteers.~   "
99955|NCT02258958|"~     Postoperative venous thromboembolism (VTE) is a significant health-care problem, resulting in~     significant morbidity, mortality and resource utilization. The true incidence is unknown, and~     may range from 1% to 15%. At the current time, the clinical practice of VTE prophylaxis in~     thoracic surgery includes administration of unfractionated or low molecular weight heparin~     starting at the perioperative period and finishing at the time of patients' discharge. In~     orthopaedic surgery, prolonged thromboprophylaxis beyond 10 days and up to 35 days has become~     the standard of care. There is a clear need to systematically evaluate the incidence of VTE~     after resection of lung malignancies and to evaluate the role of extended VTE prophylaxis in~     preventing Deep Vein Thrombosis (DVT) and pulmonary embolus (PE) after those major lung~     resections. This study will involve patients undergoing lung resection for malignancy at St.~     Joseph's Healthcare Hamilton and the University Health Network's Toronto General Hospital.~     The study will include 150 consecutively recruited patients. Study interventions will include~     Computed Tomography with pulmonary embolus (PE) protocol and bilateral extended leg Doppler~     Ultrasound for the detection of Deep Vein Thrombosis 30 days post-surgery.~      In summary, this study is aimed at evaluating, for the first time in a prospective manner,~     the actual incidence of DVT and PE in patients undergoing major lung resections for~     malignancies. The knowledge gained in this study will be used to inform a future~     investigation involving a Randomized Controlled Trial (RCT) to compare current post-operative~     thromboprophylaxis with an extended 30-day prophylaxis protocol with the hope of providing an~     evidence-based practice change in VTE prophylaxis care for this high risk population.~   "
100007|NCT02258282|"~     The purpose of this study is to evaluate safety and efficacy of etanercept in patients with~     psoriasis who had an unsatisfactory response to traditional DMARDs.~   "
100008|NCT02258269|"~     The purpose of this study is to observe the effect of square dance on rheumatoid arthritis.~   "
100043|NCT02257788|"~     PRO 140 2103 is a multicenter, randomized parallel group study, conducted in male and female~     adult subjects infected with CCR5-tropic HIV-1.~   "
100044|NCT02257775|"~     The objective of this study is to apply Whole-body DW imaging alongside the routine~     management of patients requiring systemic therapy for metastatic breast cancer to compare the~     time to progression of individual liver metastases within and between patients following~     stable disease or partial response to palliative systemic therapy for breast cancer.~   "
99956|NCT02258945|"~     Glycaemic control is an important aspect of Type 1 diabetes (T1D) management for~     diabetologists and patients alike. Evidence suggests continuous subcutaneous insulin infusion~     (CSII) is an effective method of achieving this. Among the advantages of CSII is the~     opportunity for patients to potentially discard relatively inflexible mealtimes and~     carbohydrate requirements imposed by other regimes such as multiple daily injections (MDI).~     There are also reported improvements in quality of life. Furthermore, in patients with good~     glycaemic control, such as those often assisted by CSII, various qualitative atherogenic~     lipid abnormalities may exist, despite the presence of a normal quantitative lipid profile;~     potentially leading to increased cardiometabolic risks. Literature examining the eating~     behaviours, quality of life and cardiometabolic risks of CSII patients over time after~     commencement of the therapy is sparse, frequently dated and worthy of further research.~   "
99957|NCT02258932|"~     Glycaemic control is an important aspect of Type 1 diabetes (T1D) management for~     diabetologists and patients alike. Evidence suggests continuous subcutaneous insulin infusion~     (CSII) is an effective method of achieving this. Among the advantages of CSII is the~     opportunity for patients to potentially discard relatively inflexible mealtimes and~     carbohydrate requirements imposed by other regimes such as multiple daily injections (MDI).~     There are also reported improvements in quality of life. Furthermore, in patients with good~     glycaemic control, such as those often assisted by CSII, various qualitative atherogenic~     lipid abnormalities may exist, despite the presence of a normal quantitative lipid profile;~     potentially leading to increased cardiometabolic risks. Literature examining the eating~     behaviours, quality of life and cardiometabolic risks of CSII patients over time after~     commencement of the therapy is sparse, frequently dated and worthy of further research.~   "
99958|NCT02258919|"~     Spontaneous intracerebral hemorrhage (ICH) remains a devastating disease with mortality rates~     up to 52% at 30 days. It is a major public health problem with an annual incidence of 10-30~     per 100'000 population, accounting for 2 million (10-15%) of about 15 million strokes~     worldwide each year. The strategy of decompressive craniectomy (DC) is beneficial in patients~     with malignant middle cerebral artery (MCA) infarction. Based on the common~     pathophysiological mechanisms of these two conditions, this procedure is also frequently~     performed in patients with ICH, but is has not yet been investigated in a randomized trial.~      The primary objective of this randomized controlled trial is to determine whether~     decompressive surgery and best medical treatment in patients with spontaneous ICH will~     improve outcome compared to best medical treatment only.~      Secondary objectives are to analyze mortality, dependency and quality of life. Safety~     endpoints are to determine cause of any mortality and the rate of medical and surgical~     complications after DC compared with best medical treatment alone.~   "
99959|NCT02258906|"~     Ulinastatin reduces systemic inflammatory responses and protects organs from~     ischemia/reperfusion-induced injury. The aim of this study is to evaluate the effect of~     ulinastatin on postoperative renal function in patients undergoing robot-assisted~     laparoscopic partial nephrectomy. Seventy patients, aged 20 to 79 years, scheduled for~     robot-assisted laparoscopic partial nephrectomy will be divided into ulinastatin (n=35) and~     control (n=35) groups. Randomly selected patients of the ulinastatin group are given~     ulinastatin. In contrast, patients in the control group receive an equivalent volume of~     normal saline as a placebo. The primary endpoints are postoperative renal function measured~     by serum creatinine, cystatin C, and urine output.~   "
99960|NCT02258893|"~     The purpose of this study is to determine whether reducing indoor exposure to NO2 and~     particles improves respiratory health in children with asthma.~   "
99961|NCT02258880|"~     The purpose of this study is to evaluate the safety and tolerability of SUN13837 and to~     determine whether SUN13837 improves the physical performance, relative to placebo, following~     an acute stroke in adult subjects.~   "
99962|NCT02258867|"~     The objective of this study is to assess the efficacy and safety of gevokizumab in treating~     Behcet's disease uveitis (BDU).~   "
99963|NCT02258854|"~     The purpose of this study is to provide continued dosing of gevokizumab in order to obtain~     and assess long-term gevokizumab safety data.~   "
99964|NCT02258841|"~     The purpose of this study is to assess the effectiveness of an interactive, online safety~     decision aid among diverse Canadian women who are experiencing intimate partner violence~     (IPV). The investigators will also explore how the online intervention works, and whether it~     has different effects for different groups of women.~   "
99965|NCT02258828|"~     Twenty six veterans with PTSD and cognitive impairment received 16 weeks of memantine in an~     open label fashion. Cognition was assessed using the Spatial Span, Logical Memory I, and~     Letter-Number Sequencing subtests of the Wechsler Memory Scale III (Third edition) and the~     Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). RBANS measures~     attention, language, visuospatial skills, and immediate and delayed memories. The Clinician~     Administered PTSD Scale (CAPS), Hamilton Depression Scale (HAM-D), Hamilton Anxiety Scale~     (HAM-A), Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q), and Sheehan~     Disability Scale (SDS) were used to assess improvement in PTSD symptoms, as secondary outcome~     measures.~   "
99966|NCT02258815|"~     A six courses regimen consisting of a 8 hour infusion (ch14.18/CHOmAb 20 mg/m²) for five~     consecutive days will be administered every 4 weeks, starting 60-180 days after previous~     haploidentical stem cell transplantation.~      Interleukin 2 will be added to cycles 4-6 at days 6,8,10 (1 x 106 IU/m²/d s.c.) Participants~     will be premedicated with an intravenous antihistamine and ranitidine within approximately 30~     minutes prior and during the infusion of the study agent Pain as an anticipated side effect~     is managed by a standard pain prophylaxis with Morphium hydrochloride Disease status will be~     evaluated after 3 and 6 courses and after 1 year~   "
99967|NCT02258802|"~     The purpose of this study is to develop, implement and evaluate a psychoeducational~     intervention focused to improve nutritional status, specifically micronutrients, of mothers~     and caregivers of children between the ages of 5 and 13 years and their children through~     providing healthy cooking lessons in their communities.~   "
100021|NCT02258087|"~     Investigators compare in a randomized clinical trial the results and side effects of~     high-dose- and low-dose-rate brachytherapy as monotherapy in the treatment of early, organ~     confined prostate cancer patients.~   "
100022|NCT02258074|"~     The COMBINE clinical trial is a pilot study evaluating the effects of nicotinamide and~     lanthanum carbonate on serum phosphate and fibroblast growth factor 23 (FGF23) in patients~     with Chronic Kidney Disease (CKD) stages 3-4.~   "
99968|NCT02258789|"~     There is a lack of effective rehabilitation methods for visio-spatial neglect (VSN). By using~     virtual technology, a new method (virtual reality, VR method) has been created which focuses~     on stimulating attention networks: top down scanning training in a 3D game, combined with~     intense visual, audio and tactile bottom-up stimulation, also including visuo-motor training.~      Objective. To evaluate clinical and functional improvement in stroke patients with VSN, as~     well as before and after training with the new VR method Method:- An intense visio spatial~     scanning training, enhanced by directed visual, audio and tactile stimulation cues and~     feedback, also including visio-motor activation was designed in a VR game. The in-house~     developed software was based on the Tetris game. The VR method consists of an interactive 3D~     environment: a desktop computer, a monitor, 3D glasses and a force feedback interface. 15~     patients with chronic (>6 months) visio spatial neglect was included due to right-sided~     ischemia. A VR neglect test battery including a Posner task were repeated three times during~     a 5 weeks baseline before the training started (to establish the chronic state) and again~     after 15 hours training (3x1 h for 5 weeks). Evaluation of a new method for training~     attention after stroke causing visio spatial neglect.~      The method has been designed for home rehabilitation and is well suited for a tele-medicine~     approach. It was built with standard components and is easy to manufacture at a low cost. The~     idea is to give access to effective training, to make it available at the stroke unit with~     the possibility for the patient to loan it it at discharge for home rehabilitation. The~     concept of an all in one, easy-to-use device for testing, training and outcome evaluation~     should be beneficial These preliminare results has been promising and indicates that the~     RehAtt™ method could become an further developed into an effective and stimulating~     intervention tool that would lower rehabilitation costs and reduce tiresome travelling to~     hospitals for training.~   "
99969|NCT02258776|"~     The purpose of this study is to determine the efficacy of pomegranate extract and pomegranate~     juice on skin inflammation and aging. The information gained from this study may lead to the~     development of a pomegranate product that can decrease the effects of aging, inflammation and~     harmful bacteria on the skin.~      In this study, two pomegranate products (extract and juice) will be compared with a placebo,~     a study product that looks like pomegranate extract, but contains no active ingredients.~   "
99970|NCT02258763|"~     To determine, in children hospitalized with pneumonia, if an extended duration of oral~     antibiotics (10 days) will be superior to a shorter duration (3 days) of antibiotics in~     improving clinical outcomes.~      Secondary Aims:~        1. Describe the prevalence of respiratory viruses and bacteria at presentation.~        2. Investigate the depression, anxiety and stress scores (DASS21) and quality of life~          scored (QOL) by parents of the children during admission, pre-discharge and post~          discharge and at follow-ups.~   "
99971|NCT02258750|"~     This study will examine the impact of a soluble fibre (polydextrose) incorporated into a high~     fibre tomato soup on food intake (amount and choice), appetite ratings and biomarkers of~     satiation and satiety over 4-weeks. Specifically, the impact on the development of satiation~     within the fixed-load tomato soup containing the fibre, the development of satiety after the~     fixed-load meal containing fibre and intake at subsequent ad libitum meals will be examined~     as well as the insulin response and carbohydrate fermentation before and after 4-week dosing~     of the preload soup.~   "
99972|NCT02258737|"~     Efficacy of transitional case management following psychiatric hospital discharge: a~     randomized trial~      Background The movement of deinstitutionalisation in Western societies has modified the role~     of psychiatric hospital, which has lost its asylum function to become a place for acute care.~      Psychiatric stays are now shorter and close interactions with the outpatient care network is~     therefore more critical than before. The first weeks following discharge from psychiatric~     hospital represent a period of high risk for relapse, readmission or even suicide. Case~     management has a proven efficacy in facilitating patients' deinstitutionalisation after very~     long hospitalisations and in stabilizing high users of psychiatric care. In contrast, studies~     exploring the impact of time limited case management following discharge from short stays~     (transitional case management) in earlier phases of psychiatric disorders in connection with~     primary care are lacking.~      Working Hypotheses The investigators hypothesize that transitional case management following~     hospital discharge decreases risk of readmission, improves adherence to outpatient care,~     facilitates recovery and improves patients' satisfaction with treatment as compared to~     routine care.~      Specific Aims In this study, the investigators will compare the impact of both intervention~     on number of contact and level of adherence to outpatient care. The investigators will also~     compare both groups on number of readmission, risk of early aggravation of the disorders,~     level of functioning and satisfaction with care.~      Methods This is a randomized single-blind study comparing transitional case management after~     discharge with routine post-hospitalization care for subjects living independently without~     institutional psychiatric follow-up. Demographic and clinical data will be gathered during~     hospitalization, and 1, 3, 6 and 12 months after discharge. Quantitative assessment of~     outcomes using validated instruments will be: contact and level of adherence to outpatient~     care (primary outcomes), as well as number of hospitalization days, number of readmissions,~     severity of illness and satisfaction with care (secondary outcomes).~      Expected Value of the Proposed Project This study should improve psychiatric patients~     follow-up in collaboration with the different levels of care in the global context of~     deinstitutionalization.~   "
99973|NCT02258724|"~     Due to successes in the last decades in pediatric heart surgery and cardiology, 90-95% of the~     children with congenital heart disease reach adult age.This results in an increasing number~     of adults or grown-ups with congenital heart disease (ACHD or GUCH patients) that require~     special health care organization and training programmes. Long term complications of these~     GUCH patients and optimum treatment strategies are still poorly known. The aim of this~     registry is to collect quantitative and qualitative data regarding GUCH patients treated in~     specialised centres in Switzerland.~   "
99974|NCT02258711|"~     Bipolar disorder is a frequent condition in the general population with a high~     morbimortality, which consists in dysfunctional temporal fluctuations between different mood~     phases ranging from depression to manic episodes with frequent subsyndromal symptoms between~     them. Usually during these phases, the subjects have a lack of insight about the diagnosis~     and symptoms. Besides the pharmacological treatment, additional psychological interventions~     have shown to improve the long-term outcome of the disorder, yet taking into account the~     limited resources currently available, its general implementation is still difficult and~     costly. Among these interventions, group psychoeducational programs have proved to be~     cost-effective in helping patients recognize early signs and symptoms in order to prevent~     full blown episodes which very usually are associated with a high morbidity and hospital~     admissions.~      On the other hand, numerous projects have tested the potential benefits of new technologies~     such internet in the treatment of bipolar and psychotic disorders patients using either~     online signs and symptoms monitoring or web-based psychoeducational programs, yet to the~     investigators knowledge, none of them have integrated both approaches in one single~     intervention.~      The hypothesis that, combining both interventions (signs and symptoms monitoring along with~     psychoeducational contents) in a single smart-phone application will prove to be at least~     equal or superior in terms of efficacy comparing to the standard treatment, seems promising,~     given the fact that both approaches have independently demonstrated their efficacy in the~     same population. This could extend the range of the patients in whom this kind of additional~     interventions could be implemented; preventing relapses, suicide attempts, consultations and~     hospitalizations at a much lower cost.~   "
100023|NCT02258061|"~     The optimal pacing rate during cardiac resynchronization therapy (CRT) is not known.~     Investigators investigate the impact of changing basal pacing frequencies on autonomic nerve~     function, cardiopulmonary exercise capacity and self-perceived quality of life (QoL).~   "
100045|NCT02257762|"~     The purpose of this trial is to evaluate the efficacy of the LNS on children aged 6-17 months~     in preventing growth faltering and improving micronutrient status. The impact of product will~     be compared to Corn Soy Blend ++ (CSB++), Sprinkles, and to a control group consuming an~     unsupplemented diet, which is usually borbor at an early age, and thereafter, family foods.~   "
100050|NCT02257697|"~     To demonstrate that the treatment effect in refractory nephrotic syndrome of MZR is~     non-inferior to that of standard therapy CTX through analyzing overall remission rate after~     treatment.~   "
99975|NCT02258698|"~     BACKGROUND: Surgical injury and inflammation provoke a stereotypical stress response. Insulin~     resistance plays an intriguing role in these metabolic alterations and depends on the~     intensity of injury. Metabolic derangements resulting from peripheral insulin resistance are~     unambiguously related to adverse outcomes and higher perioperative complication rates.~     Therefore, insulin resistance offers to act as a marker for stress and is potentially~     relevant in predicting clinical outcome. Plasma-glycosylated hemoglobin A (HbA1c) is an~     established indicator for blood glucose control and has a prognostic value regarding outcomes~     after major surgical interventions.~      Adipose tissue holds a key function in endocrine metabolism by releasing multiple substances,~     so-called adipose-derived secreted factors or adipokines. Recent studies have linked several~     adipokines to overall insulin sensitivity in metabolic syndrome-related conditions as well as~     in critical illness. Irisin, a recently identified myokine acts on white adipose tissue and~     plays a role in the prevention of insulin resistance.~      AIMS OF THE STUDY: The aim of this study is to assess the level and the effects of~     perioperative insulin resistance on clinical outcome in cardiac surgery patients. Based on~     previous studies suggesting glucose homeostasis and insulin resistance are associated with~     severity of illness and outcome in critically ill patients,it is proposed that patients with~     marked insulin resistance suffer from worse clinical outcome. This study protocol evaluates~     the ability of homeostasis model assessment (HOMA), quantitative insulin sensitivity check~     index (QUICKI), HbA1c, the adipokines Angiopoietin-like protein 2 (ANGPTL2), C-X-C motif~     chemokine 5 (CXCL5), and visfatin, and the myokine irisin to indicate perioperative insulin~     resistance and explores for correlation with adverse clinical outcomes after 30 days.~      MATERIAL & METHODS: 325 patients admitted to the surgical intensive care unit after elective~     on-pump cardiac surgery will be consecutively enrolled. Baseline characteristics and routine~     blood samples will be assessed the day before surgery. Study blood samples will be drawn~     preoperatively in the induction bay of anesthesia to measure the insulin resistance indices~     HOMA and QUICKI, HbA1c, ANGPTL2, CXCL5, visfatin, and irisin. Blood glucose, irisin,~     adipokines, and routine biochemical tests will be assessed upon admission to the intensive~     care unit and on postoperative days 1 and 3. Adverse outcomes will be assessed 30 days after~     surgery. Sample size is set to ensure at least 80% power at a significance level of 0.05.~   "
99976|NCT02258685|"~     This study plans to learn more about immune responses in intestinal (gut) tissue in people~     with human immunodeficiency virus (HIV) infection. This study will determine whether change~     in the composition of gut bacteria in HIV infected individuals is related to a high~     prevalence of chronic gut inflammation and metabolic disease. The investigators will also~     investigate immune-modulatory properties of specific bacteria that correlate with disease~     both by characterizing which functional genes are selected for in their genomes and by~     stimulating immune cells isolated from blood and gut tissue with bacterial isolates. This~     work will establish whether gain/loss of bacterial drivers/suppressors of information in the~     gut contributes to metabolic disease in HIV-infected individuals.~   "
99977|NCT02258672|"~     The purpose of the present study is to evaluate the effectiveness of a prehabilitation~     program on the recovery of patients undergoing a minimally invasive surgery for degenerative~     lumbar spinal stenosis. To do so, 40 participants will be recruited and randomized into two~     groups; intervention or control group. Participants in the intervention group will take part~     in a physical training program, three times a week for six weeks before undergoing surgery.~     The exercise program will be supervised and will aim at improving core muscles strength and~     endurance as well as spine stability. It is hypothesized that the prehabilitation program~     will significantly improve disability and pain intensity reported by patients after surgery.~     Ultimately, this study aims to improve health care of patients awaiting lumbar surgery but~     its results may also impact the management of patients awaiting spine surgery for various~     conditions.~   "
99978|NCT02258659|"~     This phase II trial studies nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle~     formulation) and carboplatin followed by response-based local therapy in treating patients~     with stage III or IV human papillomavirus (HPV)-related oropharyngeal cancer. Drugs used in~     chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, carboplatin,~     hydroxyurea, fluorouracil, paclitaxel, and cisplatin, work in different ways to stop the~     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them spreading. Radiation therapy uses high energy x rays to kill tumor cells.~     Giving nab-paclitaxel and carboplatin before chemoradiation may make the tumor smaller and~     reduce the amount of chemotherapy and radiation therapy needed. Assigning chemotherapy and~     radiation therapy based on response (response-based therapy) and giving patients who are~     responding well lower doses of treatment may help reduce the occurrence of side effects.~   "
99979|NCT02258646|"~     This research project aims to conduct a three-arm multi-center randomized controlled trial~     (RCT) on an innovative telerehabilitation intervention for patients with chronic obstructive~     pulmonary disease (COPD). The overall purpose of the RCT is to demonstrate whether long-term~     integrated telerehabilitation involving exercise training at home, telemonitoring, and~     education/self-management will prevent hospital readmissions, thus reducing healthcare costs,~     for patients with COPD, and will improve patient status and quality of life.~   "
99980|NCT02258633|"~     The study will use a randomized controlled design testing the effectiveness of the following~     intervention: (i) intervener brief intervention (IBI) vs. (ii) Enhanced usual care (EUC). The~     study will identify children ages 2-14 at a pediatric trauma center. Children and their~     parents who agree to participate in the study will then complete a screening survey to~     identify part time seatbelt use. Those who screen positive will complete a more detailed~     baseline survey and then be randomized to one of two study conditions. At one month, a follow~     up assessment by telephone will be completed.~   "
99981|NCT02258620|"~     The radial approach for a coronary angiography is currently adopted by several centers~     because of its simplicity. The radial artery spasm is the main inconvenient. Nitrates in~     intra-arterial have been widely studied in prevention of this spasm. No studies have compared~     the different routes of administration of nitrates as a patch and a continuous intravenous~     injection.~   "
99982|NCT02258607|"~     This study is conducted in two phases. The Dose-finding Lead-in Phase, Part A, will evaluate~     the safety and determine the maximum tolerated dose (MTD) of momelotinib (MMB) when combined~     with trametinib. Once the MTD of MMB is determined, the study will proceed to the~     Dose-finding Lead-in Phase, Part B, to determine the MTD of trametinib. After the MTD is~     established, the study may proceed to an expansion phase to determine the efficacy, safety,~     and tolerability of MMB combined with trametinib at the MTD in participants with kirsten rat~     sarcoma viral oncogene homolog (KRAS) mutated metastatic non-small cell lung cancer (NSCLC).~     Each treatment cycle will consist of 28 days and treatment will continue in the absence of~     disease progression, unacceptable toxicity, consent withdrawal, or participant's refusal of~     treatment.~   "
100046|NCT02257749|"~     The purpose of this randomized control trial study is to determine if an active~     rehabilitation (low intensity exercise program) in combination with a comprehensive education~     intervention (standard care) is more effective than the comprehensive education intervention~     alone in reducing post-concussion symptoms and improving participation in daily activities in~     youth who have persistent post-concussion symptoms.~   "
99983|NCT02258594|"~     The purpose of this project is to refine, implement, and evaluate a multi-component~     intervention that achieves sustainable and meaningful impact on healthcare quality, safety,~     and costs while ensuring dignity and respect for adult oncology and intensive care patients~     and their care partners. The PROSPECT (Promoting Respect and Ongoing Safety through~     Patient-centeredness, Engagement, Communication, and Technology) framework will achieve this~     by enhancing the patient-provider relationship and introducing patient-centered approaches to~     multi-disciplinary communication and patient education. The PROSPECT framework is based upon~     a validated structured, team-work training model and novel web-based technology. The~     overarching goals of this project are to achieve the following:~        1. Optimize the overall experience of patients (including their family/care partners) by~          promoting dignity/respect, encouraging engagement, improving care plan concordance, and~          enhancing satisfaction.~        2. Minimize preventable harms in two environments: intensive care and acute care oncology~          units.~        3. Reduce unnecessary healthcare resource utilization and associated costs.~   "
99984|NCT02258581|"~     This study will evaluate the long term effects of hepatitis B virus (HBV) treatment on the~     HBV serologic changes and HBV DNA levels through Week 144. This registry will enroll only~     individuals who were treated in a Gilead-sponsored trial for chronic hepatitis B (CHB).~   "
99985|NCT02258568|"~     This study will assess the extent of postpartum smoking relapse among Romanian women, the~     associated risk factors, and will develop, implement, and pilot-test a randomized trial~     smoking relapse intervention incorporating innovative research concepts in a social and~     cultural acceptable manner. The primary hypothesis is that the intervention will increase~     mothers' smoking abstinence rates.~   "
99986|NCT02258555|"~     This study will evaluate the safety and tolerability of GS-9901 monotherapy in adults with~     follicular lymphoma (FL), marginal zone lymphoma (MZL), chronic lymphocytic leukemia (CLL),~     or small lymphocytic lymphoma (SLL). The study will also characterize the pharmacokinetic~     (PK) profile of GS-9901, determine the appropriate dosing regimen of GS-9901 for use in~     future clinical trials, and to evaluate the efficacy of GS-9901 monotherapy in adults with~     FL, MZL, CLL, or SLL.~   "
99987|NCT02258542|"~     The purpose of this study is to characterize the safety profile of benralizumab~     administration in asthma patients who have completed one of the three predecessor studies:~     D3250C00017, D3250C00018 or D3250C00020.~   "
99988|NCT02258529|"~     The primary objective of this study is to evaluate the overall response rate (ORR) and~     complete response (CR) rate to treatment with idelalisib in combination with rituximab in~     previously untreated adults with follicular lymphoma (FL) or small lymphocytic lymphoma~     (SLL).~      An increased rate of deaths and serious adverse events (SAEs) among participants with~     front-line chronic lymphocytic leukemia (CLL) and early-line indolent non-Hodgkin lymphoma~     (iNHL) treated with idelalisib in combination with standard therapies was observed by the~     independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3~     studies. Gilead reviewed the unblinded data and terminated those studies in agreement with~     the DMC recommendation and in consultation with the US Food and Drug Administration (FDA).~     All front-line studies of idelalisib, including this study, were also terminated.~   "
99989|NCT02258516|"~     Purpose of the study - The purpose of this study is to develop and evaluate the efficacy of a~     new, theoretically based intervention to improve medication adherence in persons with HF. The~     hypotheses include:~      Hypothesis I. Poorly adherent patients with symptomatic HF who receive the intervention~     (n=40) will be more adherent to medicines during the12-month intervention than a control~     group (n=40) of poorly adherent patients with symptomatic HF.~      Hypothesis II. Poorly adherent patients with symptomatic HF who receive the intervention~     (n=40) will have fewer hospital readmissions (HR) and emergency department (ED) visits during~     the 12-month intervention than a control group of poorly adherent patients with symptomatic~     HF.~      Study Activities and population - A prospective, randomized controlled design will be used to~     pilot test the efficacy of a new intervention to promote adherence to the medication regimen~     in chronic heart failure in the clinical setting. The initial development and feasibility~     testing of the intervention is complete (Preliminary Work, Section 4.5).~      Patients with HF symptom exacerbation (n = 80) who exhibit high likelihood of poor adherence,~     as determined by a validated screening measure, the Medication Adherence Scale (MAS)89 at~     baseline assessment, will be recruited and randomized to receive the intervention or usual~     care with attention control. Medication adherence, symptom frequency and intensity, hospital~     readmissions (HR) and emergency department (ED) visits will be assessed in both groups at 3,~     6 and 12-month clinic visits. The intervals between visits are considered sufficient to~     minimize sensitization bias to psychometric measures. Longitudinal measurement is required to~     evaluate the magnitude of change in adherence and symptom-related events occurring over time.~     Efficacy will be measured as improved adherence (primary outcome) and decreased HR and ED~     visits (secondary outcomes) in the intervention group as compared to the attention control~     group at 12 months. The study will close when all patients have had a 12-month~     post-enrollment clinic visit.~      Data Analysis & Safety/Risk Considerations - The investigators will use generalized linear~     models to test the primary and secondary hypotheses (McCullagh and Nelder, 1989). Logistic~     generalizations of the traditional, multivariate GLM are appropriate when the dependent~     variable is binary and the probability of an event is modeled, as is the case with adherence~     in this study. When the dependent variable is a count, a commonly used generalized model uses~     the natural logarithm of the count, as with re-hospitalizations and ED visits in this study.~     In compliance with NIH guidelines for data safety and monitoring activities, a number of~     quality control steps will be used to ensure the on-going safety of participants and the~     scientific integrity of this feasibility intervention study. The proposed study poses only~     very minimal risks to participants. All participants will receive usual care. Participation~     in the study will not replace patients' regular health care attention. Data safety will be~     monitored by the PI, the Data Safety Officer (Dr. Karl Swedberg), and the study~     co-investigators. Any adverse events will be reported immediately to the Duke IRB and the~     NIH.~      Data Safety. First, a project database will be constructed, using participant ID numbers and~     including all demographic, pre- and post-intervention history and all assessment materials. A~     separate file, cross-referencing participant identification with project ID numbers, will be~     maintained with access limited to the PI or a designated member of the investigative team.~   "
99990|NCT02258503|"~     The pain of the elderly is even often unrecognized or trivialized and ignored in spite of its~     big frequency: the chronic pain affects 50 % of the elderly living at home, 49 to 83 % of~     those living in institution and 80 % of this population at the end of life.~      So in the elderly, the noxious character of the pain is more pregnant than at the young~     adult. The echo on the acts of the everyday life is fast, the activities decrease, coming to~     deteriorate the isolation and the dependence: the echo on the psychic state is frequent and~     the pain is a part of the cause of a confusional state. Finally, the presence of a pain~     distorts considerably the quality of life and can modify the state general as the desire of~     life.~      The evaluation of the pain appeals to the same strategy as to the younger subject but with~     some specificities, related more to the pathologies associated with the ageing than with the~     real age. For that purpose, the investigators have first of all scale of self-assessment as~     the numerical scale which is adapted to estimate the acute and chronic pains but this scale~     presents a bias because, certain patients do not express spontaneously their pain and this~     one must be attentively looked for in case of modification of behavior.~      So scales of hetero-evaluation were elaborated to solve the difficulties of detection and to~     care the pain of the elderly. One of these is the scale Algoplus® (5 items which allow within~     one minute a good quality evaluation whatever is the place of care) whose objective is the~     observation of the behavioral changes caused by the acute pain in elderly having~     communication disorders.~      Due to the demographic evolution, emergency departments are more and more frequently a place~     of consultation of the elderly. Indeed, the elderly represent approximately 10 to 20 % of all~     the passages in emergency department and 50 % of the patients hospitalized during the passage~     in the reception of Emergency department are elderly. Elderly care is difficult for a certain~     number of reasons (vulnerability, accumulation of pathologies and treatments). So, in this~     context, the evaluation of the presence of pain and its care are difficult in particular at~     the elderly with communication disorders.~      In a preliminary study in the emergency department of the Hospital of Clermont-Ferrand, on~     700 patients of more than 75 years old admitted in April 2012, 32 % had a prescription of~     analgesic while 13 % only had a real quotation of the pain.~      The aim of the investigators study is to analyze if the systematic introduction of the scale~     Algoplus® in the evaluation of elderly during its entrance to emergency department could~     modify the prescription of analgesic.~   "
99991|NCT02258490|"~     Allogeneic hematopoietic stem cell transplantation (HSCT) is an established form of treatment~     for hematological abnormalities. Poor graft function, occurs when there poor donor~     engraftment. A second infusion of unselected donor hematopoietic stem cells (HSC) can result~     in improvement, but can potentially increase the incidence of graft versus host disease.~     Cluster of differentiation 34+ (CD34+) selected stem cells depleted of T-cells is an~     attractive alternative for treatment of poor graft function as it may be associated with less~     Graft versus Host Disease (GVHD) and enhanced count recovery. The investigators are using the~     Miltenyi CliniMACS device and CD34 cell selection reagents for the preparation of allogeneic~     hematopoietic progenitor cell (HPC) transplants for patients who have had prior stem cell~     transplants and require a stem cell boost from the original donor.~   "
99992|NCT02258477|"~     To compare the effects of ingesting 100, 50 and 10 calories of glucose as compared to a~     non-calorie placebo (0 calorie beverage) on self-control over resisting snack foods. To test~     whether there is a threshold of glucose that will result in improved ease of resistance to~     problem foods (tested by comparing three different levels of glucose).~   "
99993|NCT02258464|"~     The objective of this study is to assess efficacy and safety of radium-223 dichloride in~     subjects with human epidermal growth factor receptor 2 negative (HER2 negative) hormone~     receptor positive breast cancer with bone metastases treated with hormonal treatment~     background therapy.~   "
99994|NCT02258451|"~     The objective of this study is to assess efficacy and safety of radium 223 dichloride in~     subjects with human epidermal growth factor receptor 2 (HER2) negative hormone receptor~     positive breast cancer with bone metastases treated with exemestane and everolimus.~   "
99996|NCT02258425|"~     In Phase I of this R34, the team from the University of California Los Angeles, San~     Francisco, and Irvine researchers plan to utilize the successful community participatory~     approaches to refine a gender-sensitive criminogenic needs -focused intervention program,~     Female Ex-Offender Mentoring in Care (FEM-CARE), with the help of a community advisory board,~     composed of homeless female offenders (HFOs) and addiction staff; and finalize strategies~     which will be validated by focus group sessions with the HFOs. In Phase 2, the research team~     will randomize 130 HFOs participating in one of two residential drug treatment programs to~     assess the impact of the FEM-CARE or a Health Promotion control program on reduction of drug~     and alcohol use and recidivism. This study is based upon our team's history of promoting~     theoretically-based, culturally sensitive nurse-led interventions that are enriched with~     criminal justice theoretical perspectives, and have resulted in significant reductions in~     drug and alcohol use among homeless persons, many of whom have had a history of~     incarceration.~      Specifically, the study aims are:~      AIM 1) Guided by a Community Advisory Board (CAB) made up of HFOs and addiction staff,~     further conceptualize our community-based program, Female Ex-Offender Mentoring in Care~     (FEM-CARE), to address the needs and risks of HFOs enrolled in RDT programs, and then refine~     the program in focus group discussions with 12 HFOs.~      AIM 2) Conduct a pilot RCT to assess the impact of the FEM-CARE program for 65 HFOs at~     six-month follow-up compared with 65 HFOs receiving a control Health Promotion (HP) program,~     in terms of a) self-reported and/or objective measures of drug and alcohol use; and b)~     prevalence of recidivism and number of days to first reincarceration.~      Hypothesis 2a: HFOs in the FEM-CARE program will have less drug and alcohol use at six months~     than HFOs in the HP control program.~      Hypothesis 2b: FEM-CARE HFOs will have a lower prevalence of recidivism by six months and~     greater number of days to first reincarceration than HP control HFOs.~   "
99997|NCT02258412|"~     This study will evaluate the immediate antimicrobial efficacy and persistence of two hand~     hygiene products on ICU Health Care Worker's skin flora by measuring bacterial organisms on~     hands using the hand print method. It is hypothesized that the product containing~     Chlorhexidine gluconate will provide more persistence than the alcohol product, resulting in~     less bacterial growth on the hand print plates. In addition, environmental monitoring for~     cleanliness will be captured from high touch surfaces in ICU patient rooms and common areas~     using Rodac plates and adenosine triphosphate tests.~   "
99998|NCT02258399|"~     The ability to control our blood glucose (sugar) concentrations after a meal is a strong~     predictor of the risk of disease. Our bodies respond to glucose ingestion by reducing the~     amount of glucose from the liver entering the bloodstream. At the same time muscle increases~     the amount of glucose it take up from the bloodstream. This ensures that our blood glucose~     levels do not get too high. The investigators want to understand what happens to these~     processes following exercise after breakfast and after an overnight fast. In addition, the~     investigators also want to understand whether exercising with or without breakfast influences~     our appetite, food intake and activity levels later in the day.~   "
99999|NCT02258386|"~     The aim of the present study is to implement a novel body-worn sensor, the ZephyrTM BioModule~     (the registered name for the wearable sensor device used in our study), for assessing~     physical activity and physiological measures in a clinical setting together with other~     clinical routine assessments. Our specific aim is to explore whether and how specific~     physical activity pattern and physiological measures are associated with delirium in hospital~     inpatient. Our ultimate goal is early detection and intervention of delirium, and better~     management through monitoring of activity pattern and physiological information. The ZephyrTM~     a U.S. FDA-approved wireless, ambulatory physiological monitoring device that consists of a~     data logger and transmitter unit which is attached at the location of the 5th intercostal~     space using a specifically designed patch (BioPatchTM) and standard ECG electrodes. The~     ZephyrTM is designed for long-term measurement of a patient's physical activity and~     physiological measures. By using the physical activity parameters and physiological measures,~     a specific delirium risk profile will be computed for each patient. Finally, the association~     of this delirium risk profile with CAM-ICU questionnaire as a gold standard will be assessed.~   "
100000|NCT02258373|"~     The primary objective of the study is to determine whether the routine use of Continuous~     Glucose Monitoring (CGM) without Blood Glucose Monitoring (BGM) confirmation is as safe and~     effective as CGM used as an adjunct to BGM.~   "
100001|NCT02258360|"~     This is a sub-study to the Time-differentiated Therapeutic Hypothermia (TTH48,~     ClinicalTrials.gov Identifier: NCT01689077). TTH48 compares 24 with 48 hours of therapeutic~     hypothermia at a target temperature of 32-34°C in survivors of out-of-hospital cardiac~     arrest.~      The overall aim of this sub-study is to examine the hemostasis in patients resuscitated after~     cardiac arrest and treated with 24 and 48 hours of therapeutic hypothermia~      Our specific aims are:~        -  To investigate the whole blood coagulation using the rotational thromboelastometry.~        -  To investigate the function of platelets~   "
100002|NCT02258347|"~     Use of a high intensity focused ultrasound (HIFU) in patients with non-malignant thyroid~     nodules.~   "
100003|NCT02258334|"~     The aim of this trial is to evaluate the safety and immunogenicity of the 2014-2015~     formulations of Fluzone® Quadrivalent and Fluzone® Intradermal vaccines in adults 18 to < 65~     years or age, and of the 2014-2015 formulations of Fluzone® Quadrivalent and Fluzone®~     High-Dose vaccines in adults ≥ 65 years of age.~      Objectives:~        -  To describe the safety of the 2014-2015 formulations of Fluzone Quadrivalent and Fluzone~          Intradermal vaccines in adults 18 to < 65 years of age and the safety of the 2014-2015~          formulations of Fluzone® Quadrivalent and Fluzone® High-Dose vaccines in adults ≥ 65~          years of age.~      Observational objectives:~        -  To describe the immunogenicity of the 2014-2015 formulations of Fluzone® Quadrivalent~          and Fluzone® Intradermal vaccines in adults 18 to < 65 years of age and the~          immunogenicity of the 2014-2015 formulations of Fluzone® Quadrivalent and Fluzone~          ®High-Dose vaccines in adults ≥ 65 years of age.~        -  To evaluate the compliance, in terms of immunogenicity, of each study vaccine (Fluzone®~          Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose) in the applicable age group~          with the historical requirements of the Committee for Human Medicinal Products (CHMP)~          Note for Guidance (NfG) CPMP/BWP/214/96.~   "
100004|NCT02258321|"~     This study will compare the blood levels of PPI-668 resulting from two different formulations~     - the current capsule and a new tablet, T003.~   "
100005|NCT02258308|"~     Asthmatic children age 3-17 from low income households in King County are randomly assigned~     into a community health worker (CHW) intervention group and a control group. The intervention~     is in-home education and support related to asthma self-management. The main outcome measures~     are asthma symptom-free days, caretaker's asthma-related quality of life score, and health~     care utilization for asthma measured at baseline and 12 months after baseline enrollment.~   "
100051|NCT02257684|"~     The purpose of this study is to evaluate the effectiveness,safety, and dosage of~     pegcrisantaspase in patients with Acute Lymphoblastic Leukemia (ALL) / Lymphoblastic Lymphoma~     (LBL).~   "
100009|NCT02258256|"~     The purpose of the study is to help make a lower cost automatic blood pressure monitor device~     for diagnosis and monitoring of pre-eclampsia in pregnant women, where automatic blood~     pressure monitoring is limited or not available. The study will compare this low cost device~     to a commercially available system used for pre-eclamptic women in many United States~     hospitals that the investigators will be bringing to Malawi as a part of this study.~      The team hopes to show that this lower cost blood pressure machine works well and can help~     women with pre-eclampsia. The study also aims to see if this machine is easy for the nurse to~     use.~      20 women who are either at-risk or diagnosed with pre-eclampsia will be enrolled at Queen~     Elizabeth Central Hospital. First, a nurse will fit the test device cuff on one arm of the~     subject and the commercially available cuff on the opposite arm. A trained research assistant~     and the nurse will record the blood pressure measurements and document any alarm indications~     made by each device. Blood pressure measurements will continue until monitoring is no longer~     clinically prescribed.~      The results of this study will help researchers understand the performance and usability of~     this device in Malawi and help decide if any design changes are needed.~   "
100010|NCT02258243|"~     This pilot randomized phase II trial studies how well photodynamic therapy using blue light~     or red light works in treating basal cell cancer (carcinoma) in patients with a genetic~     condition that causes unusual facial features and disorders of the skin, bones, nervous~     system, eyes, and endocrine glands, also called basal cell nevus syndrome. Photodynamic~     therapy uses drugs, such as aminolevulinic acid hydrochloride, that are taken up by tumor~     cells and when exposed to an intensive light source (blue light or red light) become active~     and may kill the cells. It is not yet known whether photodynamic therapy is more effective~     with blue light or red light in treating basal cell carcinoma.~   "
100011|NCT02258230|"~     Compare operative times and complications of sacral colpopexy and paravaginal repair between~     two-dimensional and three-dimensional laparoscopic systems.~   "
100012|NCT02258217|"~     Tolerability of Acthar for the Treatment of Multiple Sclerosis Relapses (TAMS)~   "
100013|NCT02258204|"~     KETA trial is a nonprofit, double-blind, randomized, controlled pilot trial with aiming to~     determine if co-administration of ketamine with recombinant of tissue type plasminogen~     activator (tPA) for thrombolysis in acute ischemic stroke compared with tPA co-administered~     with placebo, decreases cerebral infarction growth in diffusion weighted imaging between~     admission and day 1. Eligibility applies to patients with symptomatic ischemic stroke seen~     within 4.5 h of onset with middle cerebral artery or distal internal carotid artery~     occlusion, no contraindication to intravenous tPA-mediated thrombolysis and eligible to~     endovascular treatment of stroke (i.e. thrombectomy). The study has been designed to have 80%~     power to detect a 80% decrease of infarct volume growth in the tPA-ketamine group at a~     two-sided type I error rate of 5%. For this purpose, at least 25 patients per arm should be~     enrolled.~   "
100014|NCT02258191|"~     Pilot study evaluating feasibility and benefits of telemonitored NIV (noninvasive~     ventilation) treatment on COPD (chronic obstructive pulmonary disease) patients.~      Multicentric Randomized Controlled Trial~      Primary Objective:~      To evaluate benefits of telemonitoring system, Easy Care Online (ECO), on NIV long term~     treatment efficacy and patient compliance~      Secondary Objectives:~      To determine predictive factors of COPD exacerbation in patients treated by NIV with ECO To~     carry out a health economic evaluation on telemonitoring benefits in COPD pts treated with~     NIV~   "
100015|NCT02258178|"~     The goal of the registry is to develop a better understanding of the safety of Flucelvax in~     women and their offspring who were exposed to the vaccine during pregnancy~   "
100016|NCT02258165|"~     This study will be the first prospective study enrolling consecutive patients with advanced~     ovarian cancer to determine the prevalence of thoracic and extra-abdominal involvement in~     this patient group and the relative value of gated PET and CT for diagnosing extra-abdominal~     involvement. This study will also answer a number of other stil unanswered questions: the~     impact of gating and the impact of gated PET on clinical management of patients with advanced~     ovarian cancer. This study also individualises patients' treatment to allow patients who may~     benefit most form optimal surgical cytoreduction and those who are better treated by~     neoadjuvant~   "
100017|NCT02258152|"~     The purpose of this study placebo-controlled, randomized, double-blind study is to assess the~     safety and efficacy of SYN120 in patients with Parkinson's disease dementia (PDD) already~     treated with a stable dose of a cholinesterase inhibitor.~   "
100018|NCT02258126|"~     The objective of the present study is to evaluate the effect of 6 months exercise~     intervention program on hepatic fat fraction in overweight children.~      Methodology: A total of 160 children, 9-11 years old, will be randomly assigned to control~     (N=80) or intervention (N=80) groups. Training sessions will include 90 minutes of exercise,~     comprising warm-up and skill development. The control group will attend a healthy lifestyle~     education program (2 days/month) and the intervention group an exercise (3 days/week) and~     healthy lifestyle education (2 days/month) combined program. Before and after the~     intervention (6 months) hepatic fat fraction, body composition, , and cardiometabolic risk~     factors will be measured. Furthermore, dietary habits and physical activity, blood pressure~     and pubertal development will be evaluated before and after the intervention.~   "
100019|NCT02258113|"~     The aim of this study is to measure visual acuity and contrast sensitivity using a novel~     reaction-time based visual field device Ocusweep compared to widely used methods. Addition to~     that. the aim is to validate a novel perimetry method (Visual Search Test, VST) which is~     based on reaction times in visual decision-making task, where the subject is allowed to move~     eyes and where the fixation is verified by the subject himself in contrast to standard~     automatic perimetry (SAP) where prolonged stationary fixation and external fixation~     monitoring apparatus is required. using a novel reaction-time based visual field device~     Ocusweep compared to generally used SAP methods. Those tests will be done for healthy~     volunteers and for persons with diagnosed eye or brain disease.~   "
100020|NCT02258100|"~     To date the effect of AIMS on medical interventions has not been studied. We seek to~     retrospectively evaluate paper and electronic anesthesia records among a single surgical~     population (esophageal surgery) to ascertain any differences that may exist between cohorts~     with regards to chart completion, anesthetic management and medical care.~   "
102024|NCT02231905|"~     Study to assess the safety, tolerability and effectiveness of a switching from Domin®~     (talipexole) tablet to BI Sifrol® (pramipexole) tablet in patients with Parkinson's disease~   "
100024|NCT02258048|"~     This is a prospective study designed to examine the role of transient elastography as a~     predictor of clinical decompensation in patients with early cirrhosis. The study objective is~     to determine if changes in measurements of liver stiffness with transient elastography can~     identify patients that will have a more rapid progression of cirrhosis and the development of~     clinical decompensation. The target population is patients with early stage, well-compensated~     cirrhosis.~      Participants of this study will be asked to complete the following procedures: read and sign~     the informed consent, medical records review (complete medical history, physical examination,~     laboratory evaluation, endoscopic findings, radiographic findings), undergo transient~     elastography to measure liver stiffness every three months until the development of clinical~     decompensation (ascites, variceal bleeding, hepatorenal syndrome, overt hepatic~     encephalopathy) for up to 2 years.~   "
100025|NCT02258035|"~     The purpose of this study is to isolate genotype-specific DBP/Gc from homozygous human~     volunteers and use these purified proteins to cross-validate existing or novel assays for~     this serum protein and to evaluate the binding characteristics of these variants of DBP/Gc~     for different vitamin D metabolites.~   "
100026|NCT02258022|"~     Carbon-12 and carbon-13 are naturally-abundant isotopes in exhaled breath carbon dioxide. The~     ratio of carbon-13 to carbon-12 in exhaled breath is known as the breath delta value. This~     study is seeking to determine if the breath delta value of adults with trauma is an early~     indicator of the onset of infection that may lead to sepsis.~   "
100027|NCT02258009|"~     The purpose of the study is to compare the effect of intravitreal injections of ranibizumab~     and aflibercept on systemic VEGF protein levels in DME patients in a detailed time course.~   "
100028|NCT02257996|"~     Objective: To evaluate the effectiveness of online systematic brief psychodynamic~     psychotherapy (SBPP) via HIPAA compliant web conferencing on adults with neurotic disorders.~      Design: Randomized controlled trial. Single blind.~      Setting: Internet users in the community, in São Paulo, Brazil.~      Participants: Thirty-two adults will be randomly allocated to a group will receive online~     systematic brief psychodynamic psychotherapy (n=16), or a waiting list group (n=16).~      Method: Systematic adaptative diagnosis system will be applied in both groups at~     pre-treatment and post-treatment (or post-waiting list). Assessment will be a comparison of~     the adaptative diagnosis evolution between groups.~      Primary Outcomes: The subjects treated with online brief systematic psychodynamic~     psychotherapy will present an increase in their adaptative efficacy measured by systematic~     adaptative diagnosis scale (SADS) in comparison to the waiting list group, when contrasting~     their initial and final adaptative diagnostics.~   "
100029|NCT02257983|"~     If effective, administration of EPI-743 should have protective effects against temporary~     noise-induced hearing loss.~   "
100030|NCT02257970|"~     This study compares the effectiveness of a study drug versus placebo in the treatment of~     lymphedema to the untreated condition, in the same individual..~   "
100031|NCT02257957|"~     Dry eye is a chronic condition that decreases function and affect visual function with severe~     discapacity until now treatments are based in artificial eye drops. Platelet rich plasma has~     emerged as a strategy for cellular restoration, the purpose of this study is to evaluate~     their effects in lacrimal production and safety of this intervention in patients with severe~     dry eye.~   "
100032|NCT02257944|"~     The purpose of the study is to develop a program to help people to lower their chances of~     being violently injured again.~   "
100033|NCT02257931|"~     A significant increase in resistant bacteria emerging in HSCT recipients. For example, 25% -~     42% of all enterobacteriaceae produce extended spectrum beta-lactamases; 8 - 72% of~     Pseudomonas aeruginosa are resistant to at least one and 25 - 62% to three or more antibiotic~     classes, 13% of Gram-negative bacteria are caused by a multidrug-resistant (MDR) strain~     (Trecarichi JI 09, Mikulska BBMT 09, Oliveira BMT 07, Caselli Haemat 10, Gudiol, JAC 11).~     These resistant bacteria may be associated with increased mortality and have limited~     treatment options (Caselli Haemat 10, Poutsiaka BMT 07, DiazGranadoz JID 05). To provide the~     currently best empirical coverage and to control the growing resistance, knowledge of trends~     in antibiotic susceptibility, as well as risk factors is essential. For this reason we~     propose to perform non-interventional prospective multicentre study in EBMT centres.~   "
100034|NCT02257918|"~     This is a multi-center Phase 2 randomized, open-label study in approximately 180 adult male~     and female subjects, between the ages of 18 and 55, who are in good health and meet all~     eligibility criteria. The study is designed to assess the safety and efficacy of an~     antimicrobial investigational product, AZD0914 manufactured by AstraZeneca, administered to~     adults to treat uncomplicated urogenital gonorrhea compared to treatment with ceftriaxone.~     Subjects will be randomly assigned 70:70:40 to receive a single, oral dose of 2000 mg of~     AZD0914, 3000 mg of AZD0914, or intramuscular dose of 500 mg of ceftriaxone. The drug name is~     also known as ETX0914.~   "
100035|NCT02257905|"~     Light-chain (AL-) amyloidosis is a very rare monoclonal plasma cell disorder with poor~     prognosis. Rarity of disease has precluded performance of randomized controlled trials~     comparing various possible treatment modalities. In general, treatment of AL amyloidosis has~     been adapted from myeloma (MM) therapy. There is large experience with allo SCT in MM. Based~     on small series of patients and case reports allogeneic transplant has emerged as potentially~     effective. However, more formal proof of concept of using allogeneic hematopoietic~     transplantation for treatment of AL Amyloidosis is lacking.~      Therefore, given the limitations of conventionally collected registry data (dubious follow-up~     information and extreme heterogeneity), we developed the: EBMT non-interventional~     prospective study on allogeneic transplantation in AL Amyloidosis which means that~     transplant centers that already do perform allogeneic transplants for AL Amyloidosis will be~     encouraged to register their patients with AL Amyloidosis very timely with the EBMT, followed~     by mandatory submission of EBMT MedB and follow-up forms. The diagnosis of AL Amyloidosis~     would be based on uniform criteria. All EBMT centres performing allogeneic transplants for~     Amyloidosis will be invited to participate in this study and centres will be asked to report~     all AL Amyloidosis cases referred for transplantation using a simple registration form and~     then to submit Amyloidosis MED B forms for each transplanted patient and follow-up forms as~     necessary. In conclusion, it should be possible to largely improve the usual quality of~     registry-based data and to generate scientifically sound knowledge on HSCT in an orphan~     disease such as AL Amyloidosis.~   "
100036|NCT02257892|"~     Background:~      - The immune system helps the body fight infection and disease. People with immune system~     problems can get infections, blood disorders, and other health problems. Researchers want to~     learn more about the immune system, like what causes it to not work properly.~      Objectives:~      - To evaluate people with certain types of immune system disorders.~      Eligibility:~      - Adults and children with an immune disorder or symptoms of one, and their relatives. Some~     disorders are not included in this study.~      Design:~        -  Researchers will review participants medical records.~        -  Participants may mail in a blood or saliva sample, or be evaluated at the clinic. At the~          clinic, they may have a medical history, physical exam, blood tests, and imaging scans~          (with dye given through a needle in the arm). They may have genetic testing done on a~          sample of blood, saliva, hair, or nail clipping.~        -  Participants may choose to have a skin biopsy. Up to 2 skin samples will be taken from~          their arm, back, or other area. A biopsy punch is inserted into the skin and rotated. A~          small circle of skin is removed.~        -  Participants 10 and older may also choose to have leukapheresis. Blood is taken through~          a needle in one arm. It passes through a machine that separates the white blood cells.~          The rest of the blood is returned by needle in the other arm.~        -  Researchers may recommend medicines, but no treatments are being studied.~        -  Participants may be invited to return for visits over several years. At those visits,~          they may repeat some or all of the above tests. Or they may mail in blood or other~          samples. They may also send medical records.~   "
100037|NCT02257879|"~     Background:~      - Drinking grapefruit juice changes how long it takes some medicines to be broken down in the~     body. Researchers have found that a substance in grapefruit juice called DHB contributes to~     this effect. Some dietary supplements contain DHB and claim to increase the absorption of any~     and all supplements, medicine or any other drug. But these usually contain a lot more DHB~     than a glass of grapefruit juice. Researchers want to study the effects of grapefruit juice~     and supplements with DHB.~      Objective:~      - To compare how a certain dietary supplement (sold as DHB-300 ) versus grapefruit juice~     affects how long it takes a person s body to break down medicines.~      Eligibility:~      - Healthy volunteers ages 18 - 60.~      Design:~        -  Participants will be screened with medical history, physical exam, and blood and urine~          tests.~        -  Participants will have 3 treatment visits. Participants cannot drive themselves home~          from the visits. Each visit lasts about 13.5 hours and includes:~        -  Questions about medications and participant s health.~        -  Vital signs taken.~        -  A finger probe to measure oxygen.~        -  Blood and urine sampling throughout the visit.~        -  An IV line inserted into an arm vein. It will stay there throughout the visit.~        -  Study treatments:~        -  Midazolam hydrochloride a syrup given to make people sleepy.~        -  Loperamide a tablet for treating diarrhea.~        -  1 glass of water, 1 glass of grapefruit juice, or 1 pill of DHB-300. A different one~          will be given at each treatment visit.~        -  One week before each visit, participants cannot have certain fruits and juices. They~          must fast the night before each visit.~        -  For the 3 days after each visit, participants will return to the clinic 4 times. Their~          vital signs will be checked and blood will be drawn.~   "
100038|NCT02257866|"~     Background:~      - Vasculitis is a group of diseases that inflame and damage blood vessels and tissue. It can~     cause many medical problems. Few tests can diagnose the disease, and none can reliably~     predict a relapse. Researchers want to study people s genes and follow people over time to~     see how the disease affects them.~      Objective:~      - To learn the signs, symptoms, imaging tests, genetic markers, and blood tests that can help~     identify people with vasculitis and predict what will happen to them over time.~      Eligibility:~        -  People age 5 and older who have or are thought to have vasculitis, or are related to~          someone with it.~        -  Healthy volunteers.~      Design:~        -  Participants will be evaluated by a doctor who has expertise caring for patients with~          vasculitis.~        -  Participants will give a blood sample. Some will give a urine sample.~        -  Some participants may have brushings or biopsies taken from the inside lining of the~          nose.~        -  Images of participants blood vessels may be taken using scans. For some scans,~          participants will lie on a table that moves in and out of a cylinder that takes~          pictures. For some scans, a contrast agent may be injected into an arm vein. Other scans~          may use a radioactive form of sugar. Healthy minors will not have scans.~        -  Some participants will answer questionnaires. - Some participants will have their tests~          done at NIH. Others will have their doctor take the blood, saliva, or cheek swab samples~          and send them to NIH.~        -  Some participants will have one visit lasting 1 2 (but sometimes up to 4) days. Some~          participants may have follow-up visits every 3 6 months, indefinitely.~   "
100039|NCT02257853|"~     Background:~      - People who have an allogeneic hematopoietic stem cell transplant (HSCT) need help as they~     recover. Being a caregiver can be stressful to the body and mind. Researchers want to find~     ways to reduce this stress.~      Objective:~      - To see how a stress reduction intervention affects the stress levels and health of an HSCT~     caregiver.~      Eligibility:~      - Adults age 18 and older who plan to be an active caregiver for a person having their first~     allogeneic HSCT at the NIH Clinical Center. An active caregiver is someone who will be caring~     for the person from just before admission for the HSCT until at least 6 weeks after.~      Design:~        -  Participants will be put in either the intervention group or the control group.~        -  All participants will get the usual caregiver education given to all patients and~          caregivers having a stem cell transplant at the NIH Clinical Center.~        -  All participants will have 2 study visits. They will give blood samples. They will have~          health assessments and brief physical exams. They will fill out study questionnaires and~          have an exit interview.~        -  The intervention group will get an MP3 player. It will have an audio file with a stress~          reduction intervention on it. Participants will do this intervention daily. It takes 20~          minutes. They will do gentle stretches and breathing exercises. They will get a diary to~          track their practice.~        -  The intervention group also will have follow-up phone calls 2 and 4 weeks after their~          first clinic visit.~        -  The person getting the HSCT will not be actively involved in the study.~        -  The study will last about 2 months....~   "
100040|NCT02257827|"~     There is no randomized controlled trial (RCT) comparing Conformal Radiotherapy (3DCRT) versus~     the Intensity Modulated Radiotherapy (IMRT) in terms of toxicity and disease control. Data~     from retrospective studies show that IMRT reduces the risk of severe late complications. More~     recently, the results from the RTOG 0126 study have also confirmed the benefit from IMRT in~     reducing acute toxicity for prostate cancer treated with conventional dose escalation.~     Therefore, to investigate the real clinical benefit of the IMRT over 3DCRT using a~     hypofractionated schedule in prostate cancer, the investigators developed a RCT.~   "
100182|NCT02255942|"~     Investigation of Iron Bioavailability from extruded rice grains fortified with Ferric~     Pyrophosphate alone or in combination with different Zinc Compounds; Ferrous Sulfate serves~     as a Reference.~   "
106420|NCT02174432|"~     The primary objective of the study is to evaluate the overall safety of nalbuphine HCL ER~     tablets during a treatment period of up to 50 weeks.~   "
100052|NCT02257671|"~     The investigators aim is to evaluate effects of combined oral contraceptives (OC) on mood,~     sexuality and economic behaviour in a randomized, double-blind, placebo-controlled study. 400~     healthy women will be randomized to OC or placebo for a period of three months. Before and at~     the end of treatment, mood and sexuality will be assessed by validated instruments. At the~     end of treatment, each woman will participate in behavioral experiments testing~     self-confidence, risk taking and altruism. The current project could fill the gap of~     ignorance about causal effects of OCs on mood, sexuality and behavior. The results might~     improve current practice as regards information about OCs, choice of hormonal contraceptive,~     regimen and duration of use. As a consequence, this could lead to reduced discontinuation~     rate, fewer unintended pregnancies and abortions. The project will contribute to an overall~     improvement in women's reproductive health.~   "
100053|NCT02257658|"~     This pilot study will investigate the feasibility of conducting a large, randomized trial~     comparing a structural intervention to contingency management to reduce incident syphilis~     infections in an especially high risk group: HIV+ men who have sex with men (MSM) who have~     had syphilis twice or more since their HIV diagnosis. Subjects will be randomized to receive~     either QD doxycycline as syphilis prophylaxis or a financial incentive to remain STI free.~     The investigators will : 1) measure adherence to study visits in both arms; 2) measure~     adherence to the prophylaxis regimen; 3) measure any changes in risk behaviors among study~     participants and 4) to the extent possible in a small pilot study of short duration, compare~     effectiveness of doxycycline with that of a monetary incentive for remaining STI free.~   "
100054|NCT02257645|"~     A multicenter, observational study to evaluate the safety of Euforvac-Hib vaccine for active~     primary immunization against diphtheria, tetanus, pertussis, hepatitis B and Haemophilus~     influenza type B in infants.~   "
100055|NCT02257632|"~     The purpose of the study is to compare the effect of intravitreal injections of ranibizumab~     and aflibercept on systemic VEGF protein levels in treatment naïve wAMD patients in a~     detailed time course.~   "
100056|NCT02257619|"~     The primary objectives of this study is to evaluate the safety and tolerability of itacitinib~     in combination with docetaxel and to select doses for further evaluation (Part 1, safety~     run-in portion).~   "
100057|NCT02257606|"~     With this randomised intervention study, the investigators want to investigate the training~     effect of an 8 week training regime, using a robot-assisted training system in persons with~     MS. Besides conventional therapy, study participants in the experimental group will train 3~     times per week during 30 minutes, using the haptic master. Research questions focus on the~     effects of additional robot assisted training on range of motion, movement quality and~     clinical tests for the upper limb in persons with MS. Evaluation by means of questionnaires~     and clinical outcome measures occured at baseline, after 4 weeks, after 8 weeks and at 16~     weeks of follow-~   "
100058|NCT02257593|"~     The purpose of this study was to evaluate whether birth weight is related to the demand for~     dietary protein in adult survivors of severe acute malnutrition (Kwashiorkor and Marasmus),~     and that leveraging of protein intake is associated with total energy intake and weight~     change in the survivors consuming foods with different percentages of energy as protein~     (PEP).~   "
100059|NCT02257580|"~     E-Aminocaproic acid (EACA) is an anti-fibrinolytic agent that is used to decrease blood loss~     and transfusion requirements after several orthopedic procedures. The aim of this prospective~     double-blind placebo-controlled randomized trial is to determine whether IV EACA reduces~     intra-operative calculated total blood loss in patients undergoing bilateral varus rotational~     osteotomy (VRO). This study will also investigate intraoperative cell saver utilization,~     transfusion of allogeneic blood, hospital length-of-stay (LOS), short term complications, and~     long-term outcomes.This study will provide Level I evidence and has the potential to improve~     outcomes in children undergoing this procedure.~   "
100060|NCT02257567|"~     This study is a multicenter, open-label study of polatuzumab vedotin administered by~     intravenous (IV) infusion in combination with standard doses of bendamustine (B) and~     rituximab (R) or obinutuzumab (G) in participants with relapsed or refractory follicular~     lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL). The study comprises two stages: a~     Phase Ib safety run-in stage and a Phase II stage. The anticipated time on treatment is 18~     weeks for participants with DLBCL and 24 weeks for participants with FL.~   "
100061|NCT02257554|"~     The goals of this study are to assess concordance between the patient-surgeon pair regarding~     expectations of lumbar spine surgery.~   "
100062|NCT02257541|"~     The goal of a phase Ib clinical trial is to find the doses of drugs that are safe. Although~     BGJ398 has been given to patients safely on its own, it has never been given together with~     imatinib mesylate. In this study, we will test the safety of taking BGJ398 with imatinib~     mesylate. The investigators will learn this by closely checking for side effects that the~     patient may experience. Side effects can be seen in laboratory studies, on physical~     examination, or by asking the patient.Once a dose has been determined to be safe, a larger~     Phase II study will be done in patients with advanced GIST who have never received any prior~     treatments.~   "
100063|NCT02257528|"~     This phase II trial studies the side effects and how well nivolumab works in treating~     patients with cervical cancer that has grown, come back, or spread to other places in the~     body. Monoclonal antibodies, such as nivolumab, may block tumor growth in different ways by~     targeting certain cells.~   "
100064|NCT02257502|"~     After myopia, the second etiology of choroidal neovascularization (CNV) in young adults (<50~     years old) is idiopathic choroidal neovascularization (ICNV) whose etiology remains unknown.~     This is a rare and severe disease, which can lead to blindness.~      ICNV is treated at the moment with off-label anti-VEGF (Vascular Endothelial Growth Factor)~     therapy and could also benefit from aflibercept (EYLEA), a new anti-VEGF currently indicated~     in Age-related Macular Degeneration (AMD). Case reports suggest that such patients would not~     need as many injections as in AMD.~      INTUITION is an open-label, single arm, prospective, multicenter, phase II study. The main~     objective is to demonstrate the effectiveness in clinical terms after 52 weeks of treatment~     with aflibercept on the visual acuity of patients affected by ICNV. A specific dosage regimen~     is designed to achieve maximum efficiency. The patients are followed on a monthly basis until~     52 weeks. Intravitreal injections of aflibercept are initiated with a Treat & Extend (TAE)~     regimen until 20 weeks (3 mandatory injections with reinjection only in case of CNV~     activity). Then, a pro re nata (PRN) regimen is considered until 52 weeks (reinjection in~     case of CNV activity).~   "
100065|NCT02257489|"~     This study will evaluate the safety and tolerability of single and multiple doses of ACE-083~     as a local injection into selected skeletal muscles of healthy subjects. The study will also~     determine the amount of ACE-083 that reaches the systemic circulation following local~     administration. Additionally, the study will assess whether local administration into~     skeletal muscle results in an increase in the size and/or strength of the injected muscle.~   "
100066|NCT02257476|"~     The purpose of this study is to find the safest dose level of an approved drug, carfilzomib,~     in solid tumors when given over a different period of time than normally used. The study will~     also use markers in blood from routine blood draws to help check the levels of the drug.~     Lastly, the study will check how well this drug works with regards to keeping cancer cells~     from growing with the new time frame of delivery.~   "
100067|NCT02257463|"~     The aim is to study effectiveness of inspiratory muscle training as a part of exercise~     training in patients with Chronic Obstructive Pulmonary Disease (COPD) and if it adds to~     general exercise training program in regard to respiratory muscle strength, dyspnea, exercise~     performance and quality of life.~   "
100068|NCT02257450|"~     This research focuses on the prevalence of Primary Aldosteronism in the Malaysian adult~     population.~   "
100069|NCT02257437|"~     The purpose of this trial is to evaluate the acceptability of the LNS to women and their~     children aged 12-17 months in comparison to Corn Soy Blend++, and Sprinkles added to borbor~     (white rice porridge, which is the traditional weaning food in Cambodia). Acceptability will~     be assessed through a sensory test for caregivers, and by measuring children's consumption.~   "
100070|NCT02257424|"~     The primary purpose of this study is to determine the maximum tolerated dose (MTD) and~     preliminary safety of hydroxychloroquine (HCQ) when administered in conjunction with oral~     dabrafenib and trametinib (D+T) in patients with advanced BRAF mutant melanoma.~   "
100071|NCT02257411|"~     After institutional ethics board approval and written informed consent from parents, 197~     children scheduled for routine genitourinary operation and in whom a LMA was indicated for~     anesthesia were included in the study. The size of the LMA was determined by choosing the~     size that was best matched with the auricle of the children. The results were compared with~     the standard method recommended by the manufacturer's weight-related guidelines. The patients~     were classified in different groups depending on the PLMA sizes determined by both methods. A~     kappa coefficient evaluated the agreement between both techniques.~   "
100072|NCT02257398|"~     This is Phase I, 4-period, randomized, active-and placebo-controlled, double-blind crossover,~     single-dose study to evaluate the effects of a therapeutic (1000 milligram [mg]) and~     supratherapeutic (1800 mg) dose of GSK2140944 with a positive control (moxifloxacin 400 mg)~     and placebo on the corrected QT interval (QTc) as assessed by continuous 12-lead Holter~     electrocardiograms (ECGs) in approximately 55 healthy volunteers.~      All subjects will receive single doses of GSK2140944 1000 mg, GSK2140944 1800 mg,~     moxifloxacin 400 mg, and placebo in a randomized sequence. A double-dummy approach will be~     used to maintain blinding. Thus, on each dosing day, moxifloxacin or moxifloxacin placebo and~     GSK2140944 or placebo will be administered.~      Subjects will be screened within 30 days prior to entry to the clinic. Subjects will report~     to the clinical unit on Day -2 of Period 1 and on Day -1 in subsequent periods. Subjects will~     remain confined until check out procedures have been completed on Day 3 (5 days confinement~     in Period 1 and 4 days in the following 3 periods). There will be a washout of at least 7~     days between doses. The follow-up visit will occur 7-10 days after the final dose. Total~     duration of the study (from screening to the follow-up visit) will be approximately 60 days.~   "
100073|NCT02257385|"~     This is a Phase IIIb multicentre, randomised, blinded, triple dummy, parallel group study to~     evaluate the efficacy and safety of UMEC/VI inhalation powder (62.5/25 microgram [mcg] Once~     daily [QD]) when administered via ELLIPTA® Dry Powder Inhaler (DPI) compared to indacaterol~     plus tiotropium (150 mcg/18 mcg respectively QD) administered via individual inhalers over a~     treatment period of 12 weeks in participants with moderate to very severe Chronic Obstructive~     Pulmonary Disease (COPD). The purpose of this study is to demonstrate that UMEC/VI (delivered~     via ELLIPTA DPI), when used in symptomatic moderate to very severe COPD participants, is~     non-inferior to the combination of indacaterol (delivered via BREEZHALER® inhaler) plus~     tiotropium (delivered via HANDIHALER® inhaler) on measures of trough forced expiratory volume~     in one second (FEV1) after 12 weeks of treatment. Participants who met the eligibility~     criteria at screening (Visit 1) will complete a 5 to 7 day run in period prior to~     randomisation at Visit 2. Clinic visits will follow at day 2, week 2, week 4, week 8 and week~     12 of treatment, plus week 12 + 1 day (Visits 3 to 8). The total duration of study~     participation will be approximately 14 weeks. ELLIPTA is a registered trademark of the GSK~     group of companies. HANDIHALER is a registered trademark of Boehringer Ingelheim Pharma GmbH~     & Co. KG. BREEZHALER is a registered trademark of Novartis AG.~   "
100074|NCT02257372|"~     This is a multicenter, randomized, double-blind, parallel-group study to evaluate the~     efficacy and safety of the addition of UMEC (62.5 microgram[mcg]) when administered~     once-daily via dry powder inhaler (DPI) to Inhaled corticosteroid/ Long-acting beta2-agonist~     (ICS/LABA) twice-daily compared with placebo via DPI added to the ICS/LABA therapy over a~     treatment period of 12 weeks in subjects with COPD. This study is designed to investigate the~     addition of UMEC to ICS/LABA combinations at approved doses and frequencies for the treatment~     of COPD including SERETIDE™ 500/50 mcg twice daily, Fluticasone Propionate/Salmeterol~     Combination (FSC) 500/50 twice daily generic products such as AIRFLUSAL FORSPIRO inhaler~     500/50 mcg twice daily or ROLENIUM ELPENHALER inhaler 500/50 mcg twice daily and SYMBICORT~     TURBUHALER inhaler at doses of 200/6 mcg twice daily and 400/12 mcg twice daily, over 12~     weeks in subjects with COPD. Albuterol/salbutamol metered-dose-inhaler (MDI) or nebules will~     be issued throughout the study for use as-needed (prn).~      Subjects who meet the eligibility criteria will be randomly assigned to one of the following~     blinded study treatment regimens in equal proportion (1:1): UMEC 62.5 mcg once-daily and~     Placebo once-daily. Approximately 230 subjects (115 subjects per treatment) will be~     randomized in order to complete at least 206 evaluable subjects. The total duration of the~     study will be approximately 14 weeks for each subject.~      UMEC is a Long-acting Muscarinic Antagonist (LAMA) currently under development as a~     monotherapy, as a combination product with a LABA, vilanterol (VI), for the treatment of~     COPD, and as a combination product with an ICS, fluticasone furoate (FF), for the treatment~     of asthma. The UMEC/VI combination 62.5/25 .mcg once-daily has been approved in the United~     States (U.S.) and Canada for COPD under the trade name ANORO™ ELLIPTA™ and is under~     regulatory review in other countries.~      SERETIDE, ANORO, and ELLIPTA are trade marks of the GlaxoSmithKline Group of Companies. Other~     company or product names mentioned herein may be the property of their respective owners.~   "
100183|NCT02255929|"~     The purpose of this study is to examine effects (good and bad) of gamma knife radiosurgery~     for essential tremor. The gamma knife places a small lesion in the brain to suppress tremors.~   "
100184|NCT02255916|"~     The purpose of this study is to determine the effects of live sound-bed music on~     physiological and psychological parameters in staff of a hospital oncology ward.~   "
100075|NCT02257359|"~     Epelsiban is a potent and selective oxytocin receptor antagonist in development for enhanced~     implantation rates during in-vitro fertilization (IVF). This study a non-randomized, open~     label study designed to assess the safety, tolerability and pharmacokinetics of additional~     repeat doses of epelsiban in healthy females, and will be the first dosing experience of~     greater than 200 milligram (mg) as a single dose with this compound. Data from this study~     will inform the selection of doses of epelsiban to be used in future clinical studies. This~     study will be composed of 3 periods: Screening, Treatment, and Follow-up. The total duration~     that a subject involved in the study will be up to 6 weeks. At least 2 cohorts of subjects~     will be enrolled in this study and cohorts will be conducted sequentially. Additional cohorts~     will be enrolled if determined necessary. A sufficient number of subjects will be screened~     for the study to obtain approximately 6 evaluable subjects per cohort.~   "
100076|NCT02257346|"~     When given intravenously, the local anesthetic lidocaine has been shown to decrease the~     amount of pain medication patients require when recovering from several types of surgeries.~     Cesarean delivery is a very common surgery in the United States, effecting more than 1~     million women each year. The investigators hypothesize that lidocaine, given during and~     immediately after a patient undergoes a cesarean section, will help improve a mother's~     overall recovery experience, as well as positively influence bonding with her new baby.~   "
100077|NCT02257333|"~     The retinal vein occlusion (RVO) is the second most common retinal disease after diabetic~     retinopathy, and is a common cause of unilateral visual loss. The risk factors that~     predispose to RVO are many and are generally the same as those found in vascular alterations~     involving other parts of the body, as in the case of stroke or coronary heart disease.~     Several authors have attempted to determine whether the pathogenesis of RVO can be of~     arterial type, considering the disease as consequent to atherosclerosis, rather than~     resulting from venous disease. Although less frequent than the other diseases RVO affects~     considerably on health care costs. Direct medical costs showed that in one year a patient~     with this disease has a higher than average cost for a patient with hypertension or glaucoma.~     Knowing the prevalence of the disease in Italy and identify modifiable risk factors,~     recognizing additional risk factors related to gender, genetic predisposition and especially~     the social-economic and cultural background in the pathogenesis of RVO, are the objectives~     that led to the planning of this study. In order to assess the prevalence of the disease and~     the current clinical practice we aim to create an online register between Italian~     specialist centers (ophthalmic emergency care and thrombosis centers) with immediate~     portability and usability of the data.~   "
100078|NCT02257320|"~     The study is an open-label, prospective, single-center, non-randomized feasibility study of~     the Bruxoff(TM) device to identify EMG activity associated with bruxism, and to assess the~     impact of the TMJ NextGeneration(TM) device upon the occurrence of night-time bruxism events~     and incidence of migraines and headache in subjects diagnosed with sleep bruxism.~   "
100079|NCT02257307|"~     Evaluating retinopathy of prematurity (eROP) ancillary study Implementation Project is a~     multi-center observational study will focus on feasibility, and relative cost-effectiveness~     of an retinopathy of prematurity (ROP) telemedicine evaluation system to detect eyes of~     at-risk babies and provide timely feedback to the examining ophthalmologist at the Clinical~     Center.~   "
100080|NCT02257294|"~     The purpose of this study is to determine the safety and efficacy of reduced doses (10 mg and~     20 mg) of intra-coronary alteplase compared with placebo as an adjunct to PCI in reducing MVO~     and its consequences in high risk patients with STEMI.~   "
100081|NCT02257281|"~     The purposes of study are to investigate the effect of therapeutic ultrasound for the~     inflammatory skin repair and whether the tissue repair under ultrasound treament is depend on~     different inflammatory level.~   "
100082|NCT02257268|"~     The main purpose of this study is to evaluate the effectiveness of VAMOS program, a physical~     activity and healthy eating promotion program, in hypertensive from Recife-Pernambuco-~     Brazil. Approximately 90 subjects with a diagnosis of hypertension, under anti-hypertensive~     medication and classified as non-physically active, will be selected and randomly distributed~     into two groups: a change behavior group (CBG) and control group (CG). The CBG will~     participate of a change behavior program, entitled VAMOS - Active Life Improving Health, for~     12 weeks and composed of a weekly meeting, in group, lasting about 90 minutes. In each weekly~     meeting, will be presented and discussed guidelines and strategies for practical physical~     activities in different fields and for adoption of a healthy diet in order that the level of~     physical activity and eating quality improve. The program will be evaluated by effectiveness,~     implementation and maintenance (initial and individual level) dimensions of RE-AIM framework.~     The effectiveness will be assessed from anthropometric measurements, body composition, eating~     habits, physical activity level, stages of self-change, self-efficacy, social support,~     quality of life and assessment of cardiovascular function at rest (clinic and home blood~     pressure, arterial stiffness, blood flow and flow-mediated dilation, heart rate and heart~     rate variability) before and after 12 weeks of intervention. The implementation will be~     assessed by identifying the extent to which the program will be conducted as planned. The~     maintenance, initial and at individual level, will be estimated from revaluations of all~     outcomes, as measured before and after the intervention, three months after the end of the~     program. For data analysis, in addition to descriptive statistics, two-way ANOVA for mixed~     models wil be applied for for within and between groups comparison, if the premises of this~     test are met. The level of significance that will be adopted is P<0.05. All analyzes will be~     done at SPSS statistical package, version 17.0.~   "
100083|NCT02257255|"~     Cesarean section is the most performed abdominal surgery in women, worldwide. The World~     Health Organization (WHO) considers 15% of deliveries the ideal rate of this surgery.~     However, Brazil presents the highest rates of cesarian section in the world, reaching 85% in~     hospitals and private clinics.~      The most used technique of cesarean section is the known as Pfannenstiel or Classical~     technique. In 1996, a new technique was described, called Misgav Ladach or minimally invasive~     technique.~      Several studies have show that the minimally invasive technique is faster and promotes lower~     costs and less intraoperative bleeding. There is no current evidence that this technique is~     less painful.~      This study aims to compare the postoperative pain in both techniques,by means of two pain~     scales: a one-dimensional scale, the Visual Analogue Scale, and a multidimensional scale, the~     McGill Scale.~   "
100084|NCT02257242|"~     This study evaluates addition of Vincristine Sulfate Liposome Injection (Marqibo®) to the~     standard regimen of Bendamustine and Rituximab in adult patients with indolent B-cell~     lymphoma. This is a dose-escalation study.~   "
100085|NCT02257229|"~     All patients who meet inclusion criteria and who agree to participate in the study will be~     evaluated for classification of clubfoot reducibility (Dimeglio 1995), which characterizes~     the four components of clubfoot deformity including equinus, heel varus, calcaneopedal~     rotation, and forefoot adduction.~      Patients will be allowed to select treatment with either the daily massage and taping~     technique or the Ponseti casting technique. It is not practical or feasible to randomize~     patients as transportation and scheduling, as well as family preference and willingness to~     participate, are primary factors in the French physical therapy method of massage/taping.~      Once treatment intervention has been determined, patients will be enrolled into the surgical~     or one of two non surgical arms (French physical therapy or Ponseti casting) of the study.~     Research participation entails the retrospective and prospective review of data collected~     through standard medical care.~      All patients who undergo clubfoot treatment, may have the following evaluations:~      Standard-of-care~        -  Clinical exams- will be conducted at the initial visit, 4 weeks, 8 weeks, 12 to 14~          weeks, 6 months, and 9 months following treatment. Also at 1 year, 18 months, 2 years, 3~          years, 4 years, 5 years, and 10 years of age and at skeletal maturity.~        -  Radiographs- standing AP and laterals of both feet may be taken at 18 months, 4 years of~          age, and at skeletal maturity (for a total of 12 possible radiographs over the span of~          the study).~      Investigational~        -  Questionnaires - at age 4, age 10, and at skeletal maturity: patient/parent baseline~          assessment.~        -  Radiographs- standing AP and laterals of both feet (for a total of 4 radiographs) will~          be taken for all adult participants.~        -  Movement Science Lab- at 2, 5, 10 years of age and at skeletal maturity. This testing~          may include walking with reflective markers and electrodes attached with tape to his/her~          legs, walking across a pressure plate, video, digital pictures, wearing a step monitor,~          strength testing, and an agility test.~        -  Physical therapy - at 4 years of age: developmental motor scale; at 10 years of age and~          at skeletal maturity: motor proficiency assessment.~        -  Brace compliance - patients will have a temperature logger placed in the shoes of the~          Dennis-Browne Bar at the initial fitting visit in the Orthotics department. At every~          subsequent clinic follow-up visit the Orthotist downloads the time/temperature data onto~          a laptop from the sensor reader (A piece of computer hardware which the sensor clips~          into and is attached to the laptop via the USB port). The Orthotist will then reset the~          temperature logger discs in order to monitor the next period of brace wear.~      The following additional evaluations may be conducted on the patients who also have surgical~     treatment of clubfoot:~      Standard-of-care • Clinical exams and radiographs will be conducted as is required by the~     surgeon. No additional radiographs are needed for investigational purposes.~      Investigational~      • Movement Science Lab testing may be done before surgery, 1, 2,5, and 10 years following~     surgery, and at skeletal maturity.~      In addition, relevant retrospective data from your child's medical chart including clinical~     history, radiographs, and data collected in the Movement Science lab, may be used.~   "
100086|NCT02257216|"~     The primary study objective is to evaluate the efficacy of Vayarin in ADHD adults.~   "
100087|NCT02257203|"~     This is a pilot randomized clinical trial of a brief educational intervention offered in~     primary care for Latino parents that promotes healthy beverage consumption by infants and~     toddlers. The control group will receive an educational intervention that promotes parents~     reading to children.~   "
100088|NCT02257190|"~     A single bout of Interval-Walking (IW) exercise is superior to energy-expenditure and~     time-duration matched Continuous Walking (CW) exercise upon improving glycemic control. The~     reason IW is superior is unknown.~      This study will look into whether it is the larger peak intensity during IW or if it is the~     alternating exercise pattern that is responsible for the larger improvements seen.~      Subjects with type 2 diabetes will be included in a crossover, counter-balanced, controlled~     study, where each subject will undergo three trials. Trials will be identical except the~     following interventions:~        1. One hour of rest (Con)~        2. One hour of classical interval walking (repeated cycles of 3 min of fast and 3 min of~          slow walking; IW3)~        3. One hour of fast alternating interval walking (repeated cycles of 1 min of fast and 1~          min of slow walking; IW1).~      After the interventions subjects will undergo a standardized mixed meal tolerance test, with~     consecutive measurements of blood glucose, insulin and c-peptide.~   "
100089|NCT02257177|"~     This study will be divided into 2 parts. Part 1 is a randomized, double-blind, single centre,~     placebo-controlled, single ascending dose (SAD) phase I study designed to assess the safety,~     tolerability, PK and PD (Pharmacodynamic) of TD139 in up to 36 healthy male subjects. Part 2~     will be a randomized, double-blind, multi-centre, placebo-controlled, multiple dose expansion~     cohort, designed to assess the safety, tolerability, PK and PD of TD139 in up to 24 male~     subjects and female subjects of non child-bearing potential with IPF.~   "
100090|NCT02257164|"~     Surgery of the anterior cruciate ligament of the knee is frequently a young patient surgery.~     The post-operative pain of this surgery is managed according to recommendation. In the~     majority of case, femoral nerve block is performed. The femoral nerve block can cause~     paralysis of the quadriceps more or less complete that no allowing a good quadriceps~     locking. This locking is indispensable to avoid post-operative flexima and to ensure~     stabilization of the knee during walking.~      In France, the surgery requires a duration of hospitalization from 2 to 4 days in the most~     cases. It is sometimes performed in ambulatory especially in the USA. But, at the home, pain~     requires powerful analgesics with their adverse events.~      Today, no anesthesic technics for surgery of anterior cruciate ligament of the knee ensure in~     the same time optimal analgesia and optimal quadriceps locking. The main objective of the~     investigators study is to compare two analgesia techniques : femoral nerve block vs intra~     articular injection and obturator nerve block in surgery of the anterior cruciate ligament of~     the knee~   "
100091|NCT02257151|"~     The purpose of this study is to evaluate the safety, pharmacokinetics, and target engagement~     of BMS-986142 in healthy subjects.~   "
100092|NCT02257138|"~     This clinical research study is made up of 2 parts: Phase 1 and Phase 2.~      The goal of Phase 1 of this study is to find the highest tolerable dose of the combination of~     decitabine and ruxolitinib that can be given to patients with AML.~      The goal of Phase 2 of this study is to learn if decitabine and ruxolitinib can help to~     control a certain kind of AML called post myeloproliferative neoplasm AML (post MPN-AML).~      The safety of the drug combination will be studied in both phases.~      This is an investigational study. Ruxolitinib is FDA approved and commercially available for~     the treatment of patients with intermediate or high-risk myelofibrosis. Decitabine is FDA~     approved and commercially available for the treatment of patients with several different~     types of myeloid diseases such as myelodysplastic syndromes (MDS). It is investigational to~     give these drugs in combination with each other to patients with AML.~      Up to 42 participants will be enrolled in this multicenter study. All will take part at MD~     Anderson.~   "
100093|NCT02257125|"~     This study investigates the use of motivating/rewarding features in a computer based arm~     rehabilitation program. Half of the subjects will take part, besides receiving standard~     therapy, in a computer based program delivering a game like scenario with visual effects and~     monetary rewards in case of successful level completion, while the other half will take part~     in a similar program without visual effects or the possibility to earn money.~   "
100094|NCT02257112|"~     Multistage low-energy pulses are being evaluated for their effect on atrial fibrillation~     during an acute testing procedure.~   "
100095|NCT02257099|"~     The primary hypothesis is that measures of patellofemoral alignment obtained from the~     investigational cone beam CT scanner will be reduced, but still correlated to those obtained~     from the conventional CT scan.~   "
100096|NCT02257073|"~     To evaluate the effectiveness of Cognitive-behavioral treatment for people with rheumatoid~     arthritis~   "
100097|NCT02257060|"~     The Linear II study is a prospective, single center, non-randomized, interventional~     feasibility study with the purpose of assessing acute safety of the Multi-Electrode Linear~     Type Ablation Catheter and the performance of the product when used for the treatment of~     symptomatic CTI (cavotricuspid isthmus) dependent right atrial flutter.~   "
100098|NCT02257047|"~     To evaluate the effect of red yeast rice on subclinical atherosclerosis in patients with~     rheumatoid arthritis~   "
100099|NCT02257034|"~     To evaluate the effect of Tai chi on Fibromyalgia~   "
100100|NCT02257021|"~     To determine the effect of BILR 355/r on tipranavir/r pharmacokinetics and the effect of~     tipranavir/r on BILR 355 BS pharmacokinetics~   "
100101|NCT02257008|"~     Assessment of the effect of different boosting agents on pharmacokinetics of a single dose of~     BILR 355 BS dissolved in PEG 400~   "
100102|NCT02256995|"~     A prospective observational study to test the feasibility of smartphone enabled uChek~     urinalysis device to detect biomarkers (protein, microalbumin and protein:creatine ratio) in~     urine, indicative of preeclampsia/eclampsia at over 22 weeks of gestation and assess~     attitudes of clinicians towards uChek as a new technology for urinalysis.~   "
100103|NCT02256982|"~     This research study is evaluating the use of radiation therapy in combination with~     chemotherapy as a possible treatment for intrahepatic cholangiocarcinoma, a rare form of~     gastrointestinal cancer.~   "
100104|NCT02256969|"~     In this research study, the investigators are looking at the effects of Meibomian Gland~     Probing (MGP) versus a sham (fake) procedure in patients with refractory MGD who have already~     tried traditional management with no success in resolving their clinical signs (as seen by~     their ophthalmologist) or their symptoms.~      The investigators are also evaluating the effects of using two (2) post-procedural medication~     treatments: Blephamide or GenTeal PM Night-Time to determine if treatment after the MGP~     procedure has an effect on its outcome.~   "
100105|NCT02256956|"~     Low dose tricyclic antidepressant drugs are routinely administered co-analgesics in pain~     medicine. Amitriptyline is largely considered as a gold standard. Amitriptyline underlies~     cytochrome CYP2D6 and CYP2D19 metabolism. CYP2D6 is highly polymorphic; numerous genetic~     variants result in 4 major classes characterizing enzymatic activity: poor metabolizers,~     intermediate metabolizers, extensive metabolizers and ultrarapid metabolizers. It is not~     known to which extent metabolizer classes determine pain outcomes or side-effects. As only~     one in three pain patients is considered to be a responder to amitriptyline's co-analgesic~     effect, prediction of treatment efficacy with a fast and easy to perform bedside test may~     contribute to the patients quality of life. The aim of this study is to determine the~     influence of cytochrome variants on experimental pain, drug related side-effects and finally~     identification of active metabolites.~   "
100106|NCT02256943|"~     Low dose tricyclic antidepressant drugs are routinely administered co-analgesics in pain~     medicine. Amitriptyline is largely considered as a gold standard. Amitriptyline underlies~     cytochrome CYP2D6 and CYP2D19 metabolism. CYP2D6 is highly polymorphic; numerous genetic~     variants result in 4 major classes characterizing enzymatic activity: poor metabolizers,~     intermediate metabolizers, extensive metabolizers and ultrarapid metabolizers. It is not~     known to which extent metabolizer classes determine pain outcomes or side-effects. As only~     one in three pain patients is considered to be a responder to amitriptyline's co-analgesic~     effect, prediction of treatment efficacy with a fast and easy to perform bedside test may~     contribute to the patients quality of life. The aim of this study is to determine the~     influence of cytochrome variants on experimental pain, drug related side-effects and finally~     identification of active metabolites.~   "
100107|NCT02256930|"~     This is a single center, randomized, controlled, within subject comparison, multiple dose~     study to determine the sensitization potential of M518101 on normal skin under occlusive~     patch condition.~   "
100108|NCT02256917|"~     The rationale of this study is to further fine-tune and individualize prophylactic treatment~     of patients with severe Haemophilia A with the goal of keeping the trough FVIII level above~     1% between doses. Because trough FVIII levels are likely to be important predictors of the~     efficacy of prophylaxis, the focus of this study is on PK data.~   "
100109|NCT02256904|"~     Current practice in orthopedics is to recommend TKA implantation with the femoral and tibial~     components perpendicular to their mechanical axis. Therefore, current surgical technique does~     not replicate natural knee anatomy and biomechanics. An alternative alignment method that~     attempts to replicate the kinematics of the knee is  kinematic alignment . The principle~     behind kinematic alignment is placement of the TKA components so that the orthogonal 3-D~     orientation of the 3 axes that describe normal knee kinematics is restored to that of the~     prearthritic knee. Theoretical benefits of kinematic alignment include less ligamentous~     release to balance the knee intra-operatively, more rapid recovery, better range of motion~     (ROM), less post-operative pain, better knee biomechanics, and improved patient satisfaction.~     However, a major concern is that there are no mid- or long-term data on implant survivorship~     (absence of loosening) in TKA based on anatomical implantation. The investigators propose~     to compare the clinical results of TKA implanted with mechanical alignment (standard~     practice) to kinematic alignment, in a double-blind, randomized trial.~   "
100110|NCT02256891|"~     This study is a single-blind, randomized study evaluating the 6 month and 2 year outcomes of~     patients treated with arthroscopic rotator cuff repair using one of two techniques. One~     technique used is the standard double row repairs utilizing medial and laterally based anchor~     fixation and the other technique is the standard double row repairs utilizing medial and~     laterally based anchor fixation with the use of plateley rich fibrin membrane (PRFM). It is~     hypothesized that patients undergoing the surgery with the PRFM will report a higher quality~     of life than the patients that do not receive this treatment.~   "
100111|NCT02256878|"~     The objective of the study was evaluate that there is no clinically relevant interaction~     between amitriptyline (or its metabolite nortriptyline) and BIRT 2584 XX (or its metabolite~     BI 610100) when BIRT 2584 XX is administered as a tablet formulation to near steady state in~     an estimated high therapeutic dose. Pharmacokinetics (PK) of amitriptyline and nortriptyline~     were measured before dosing of BIRT 2584 XX, after the first dose of BIRT 2584 XX, and after~     repeated doses of BIRT 2584 XX near steady state~   "
100112|NCT02256865|"~     The purpose of this study is to study the effects of sleep restriction on the production of~     two hormones, cortisol and testosterone. The investigators aim to show that changing these~     hormones leads to insulin resistance, which is an important cause of type 2 diabetes~     mellitus. The investigators may also study the effect of sleep restriction on your food~     intake and cravings, mood, inflammation, metabolism (including bone), and other hormones.~     Inflammation is your body's response to stress and injury. Bone metabolism is a process of~     how your body regenerates (renews) new bone cells and removes old bone cells. Hormones are~     natural substances (materials) that are produced in the body and that influences (effects)~     the way the body grows or develops.~   "
100113|NCT02256852|"~     The purpose of this study is to evaluate the safety, tolerability, compliance and mechanism~     of action of study drug (QBKPN SSI) in subjects with two or more second primary pre-invasive~     or invasive adenocarcinoma following surgical section of Stage 1 NSCLC.~   "
100114|NCT02256839|"~     To compare the results of the investigational test to the currently approved QuantiFERON-TB~     Gold In-Tube test.~   "
100115|NCT02256826|"~     To determine the pharmacokinetic effect of BILR 355 BS on Kaletra® and of Kaletra® on BILR~     355 BS~   "
100116|NCT02256813|"~     The study aimed to investigate the effect of BIRT 2584 XX and its metabolite BI 610100 on the~     Pharmacokinetics (PK) of five probe substrates for cytochrome P450 isozymes.~      The substrates used to monitor enzyme activity were oral warfarin (for CYP2C9), oral~     omeprazole (for CYP2C19), oral dextromethorphan (for CYP2D6), oral caffeine (for CYP1A2) and~     intravenous midazolam (for hepatic CYP3A)~   "
100185|NCT02255903|"~     The aim of this study is to assess the values of MCA PI / UA PI and MCA RI / UA RI ratios and~     amniotic fluid volume in predicting the adverse perinatal fetal outcome in uncomplicated~     postdate pregnancy~   "
100186|NCT02255890|"~     The aim of this registry is to assess the recurrence of prostate cancer at 1 and 5 years, as~     well as the change in functional outcomes (e.g. incontinence or erectile function) from~     baseline. Secondary objectives are to establish which indications lead to treatment with IRE~     Nanoknife® setting and safety assessment measured by number of complications and adverse~     events.~   "
100117|NCT02256800|"~     Metastatic diseases were found in 20-25% of patients with initial diagnosis of colorectal~     cancer and developed in up to 50% of patients. Owing to limited post-treatment response of~     5-fluorouracil (5-FU) combined with leucovorin (LV) obtained in mCRC (metastatic colorectal~     cancer) patients, other therapeutic agents with different mechanisms were considered, such as~     irinotecan, a potent inhibitor of topoisomerase I, which is involved in the unwinding of DNA~     during replication. Bevacizumab is a humanized monoclonal antibody that inhibits tumor~     angiogenesis by blocking vascular endothelial growth factor (VEGF) and was the first~     antiangiogenic agent approved for the treatment of cancer.~      Infusional fluorouracil/leucovorin plus irinotecan-based regimen (FOLFIRI) with bevacizumab~     has been widely used as first-line treatment for patients with metastatic colorectal cancer~     (mCRC). Recently, the investigators have shown that prospective analysis of uridine~     diphosphate glucuronosyl transferase 1A1 (UGT1A1) genotyping for irinotecan dose escalation~     (FOLFIRI regimen) with combination of bevacizumab biweekly as the first-line setting in mCRC~     patients (ASCO Abstract #491 - 2013 Gastrointestinal Cancers Symposium).~      In this study, the investigators will enroll approximately 320 mCRC patients (It was~     considered that an increase of response rate of 15% compared to conventional irinotecan dose~     of 180 mg/m2, and these were chosen as parameters with which to calculate the study power.~     Initial power calculation was suggested that a minimum of 140 patients in each group would be~     required to achieve statistical significance with a power of 80% at the 5% significance~     level. It is estimated that about 10% of 320 mCRC patients fail to complete the study). For~     these enrolled patients, the investigators will randomize and divide these patients into two~     groups: control group and study group. Control group includes mCRC patients who will receive~     the conventional regimen of FOLFIRI plus bevacizumab. Otherwise, patients in the study group~     will have genotyping of UGT1A1 before therapy, and dose escalating of irinotecan will depend~     on results of genotyping.~   "
100118|NCT02256787|"~     The objective of the current study was to investigate the safety, tolerability, and~     pharmacokinetics of BILB 1941 ZW following the administration of single rising doses from 5~     mg to 300 mg. In addition the bioavailability of the 60 mg dose given fasted and after a~     high-fat breakfast was to be be investigated~   "
100119|NCT02256774|"~     Study to determine the effect of BILR 355/r on Combivir® pharmacokinetics and the effect of~     Combivir® on BILR 355 BS pharmacokinetics.~   "
100120|NCT02256761|"~     The study comprised two parts. The objective of the first study period was to assess the~     safety and pharmacokinetics of 500 mg of BIRT 2584 XX tablets administered with and without~     food in male healthy volunteers and to determine the relative bioavailability of the BIRT~     2584 XX tablet formulation compared by historical comparison to BIRT 2584 XX powder in PEG~     400 (U05-2074) (part 1). The second and major phase of the trial was aimed at evaluating the~     safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple rising doses of BIRT~     2584 XX (100 mg, 250 mg, and 500 mg bid on the first 2 days and qd on the following 12 days,~     or 750 mg qd for 28 days) in healthy male subjects (part 2)~   "
100121|NCT02256748|"~     The objective of the study was to investigate the effect of BIRT 2584 XX and its metabolite~     BI 610100 when BIRT 2584 XX is administered as a tablet to near steady state in estimated~     high therapeutic dose on the pharmacokinetics (PK) of midazolam, a probe substrate for~     CYP3A4. The PK of midazolam was measured before dosing of BIRT 2584 XX, after a single dose~     of BIRT 2584 XX and after repeated doses of BIRT 2584 XX for 3 and 12 days~   "
100122|NCT02256735|"~     Study to investigate the effect of Ritobegron CL (KUC 7483 CL) on the QT/QTc interval of the~     ECG in comparison to placebo and moxifloxacin~   "
100123|NCT02256722|"~     Study to compare the metabolic and electrolyte effects of a single oral dose of 320 mg~     ritobegron administered alone or with a pre- and comedication with bisoprolol, propranolol~     and acipimox. In addition, to compare the metabolic and electrolyte effects of a single dose~     of 320 mg ritobegron with those of a single inhalatory dose of 100 μg salmeterol~   "
100124|NCT02256709|"~     Safety, tolerability and pharmacokinetics (including comparisons of different formulations~     and investigation of food effect)~   "
100125|NCT02256696|"~     Assess the mycobactericidal activity of PA-824 (given at 200 mg daily) when added to~     first-line tuberculosis (TB) treatment (isoniazid, pyrazinamide, and a rifamycin antibiotic)~     over 12 weeks of treatment. Funding Source - FDA OOPD~   "
100126|NCT02256683|"~     The primary objective of this study is to assess whether Dabigatran leads to a faster~     complete left atrial appendage (LAA) thrombus resolution as compared to Phenprocoumon. The~     secondary objectives of this trial are to assess the impact of Dabigatran versus~     Phenprocoumon on complete LAA thrombus resolution rate until week 6 and change in LAA~     thrombus volume under treatment as well as to assess and compare safety and tolerability of~     both drugs. A total of 110 patients with atrial fibrillation and LAA thrombus will be~     randomized to receive either Dabigatran (150 mg bid) or Phenprocoumon (INR 2-3) for a least~     three weeks. Thrombus resolution will be determined by transoesophageal echocardiography~     (TEE) 3 weeks after start of study treatment and subsequently at week 4 and 6 if necessary,~     i.e. LAA thrombus has not yet resolved. The study is terminated for each patient with the~     resolution of the LAA thrombus. For those patients whose thrombus still exists after 6 weeks~     treatment, the study is also terminated. Further treatments will be decided at the discretion~     of the treating physician.~   "
100127|NCT02256670|"~     Pilot study to assess feasibility and patient acceptance of a text message cell phone~     application for patients with stage I-III, hormone receptor positive breast cancer who start~     adjuvant endocrine therapy.~   "
100128|NCT02256657|"~     The trial assesses the effect on 30-day major adverse cardiovascular event (MACE) rate of~     using a quality improvement toolkit among hospitals in Kerala, India. The quality improvement~     toolkit includes standardized admission and discharge sets, clinical pathways and an audit~     and feedback program.~   "
100141|NCT02256488|"~     The purpose of this study is to evaluate the immunologic equivalence of three consecutive~     lots of a cell based trivalent subunit influenza vaccine (TIVc), and to assess~     immunogenicity, safety and tolerability of the vaccine and an egg based trivalent subunit~     influenza vaccine (TIVf).~      The study comprised 1 vaccination, 2 clinic visits, 3 reminder calls and 2 blood draws.~     Female subjects of childbearing potential were tested for pregnancy before the administration~     of the vaccine and included only if using and agreeing to continue to use contraception~     during the course of the study.~      The total study participation time per subject is about 3 weeks.~   "
100142|NCT02256475|"~     This is a Phase 1b, open-label, multiple-dose study of the safety, pharmacokinetics (PK), and~     pharmacodynamics (PD) of NBI-98854 in a total of 36 pediatric subjects with Tourette syndrome~     (TS). The study will be conducted in approximately 18 male and female children (6 to 11 years~     of age) and approximately 18 male and female adolescents (12 to 18 years of age). Both age~     groups will be divided equally into 3 dosing cohorts with 6 subjects each. Ascending doses~     will be evaluated as part of a staggered-cohort design. Study drug will be administered in~     each cohort for 14 consecutive days.~   "
100129|NCT02256644|"~     Posttraumatic Stress Disorder (PTSD), as a common and serious mental health condition,~     affects about 25% of all military personnel that have served in combat. People suffering from~     PTSD may experience traumatic flashbacks, trouble sleeping, and problems in their~     relationships. This study is intended to help identify genes that influence and increase the~     risk of PTSD, to improve ways of detecting and treating the condition in the future.~      Previous research has studied genes that increase the risk of PTSD, but none of these have~     included a Veteran-only population. The current study focuses on US Veterans, utilizing the~     VA Million Veteran Program (MVP) database of approximately 300,000 participants as of August~     2014. In this context, participants with PTSD are referred to as cases and Veterans without~     PTSD are referred to as controls.~      This project will be done in three stages. The first stage will look at MVP-obtained data and~     electronic health record (EHR) data to implement methods for identifying combat-exposed case~     patients with PTSD and combat-exposed control patients without PTSD. The second stage will~     assemble and validate a study population of 20,000 participants including 10,000~     combat-exposed Veterans with PTSD as cases and 10,000 combat-exposed Veterans without PTSD as~     controls. The third stage will conduct genetic analyses (genotyping) comparing the cases to~     controls, to identify genes associated with increased risk of developing the condition.~   "
100130|NCT02256631|"~     The purpose of this study is to assess the safety and pharmacokinetics (PK) of two monoclonal~     antibodies, VRC01 and VRC01LS, in HIV-exposed infants who are at increased risk of~     mother-to-child HIV transmission.~   "
100131|NCT02256618|"~     This is a pilot study to test feasibility and safety of intravenous infusion of autologous~     umbilical cord blood cells in the first 72 hours after birth if a neonate is born with signs~     of encephalopathy.~   "
100132|NCT02256605|"~     The purpose of this prospecitve randomized controlled trial is to compare effectiveness and~     patient/family adherence of weekly or daily Vitamin D-3 dosing regimens in children with~     Inflammatory Bowel Disease (IBD) who are 25-hydroxyvitamin D [25(OH)D] insufficient or~     deficient. The primary aim of this pilot study is to evaluate the effectiveness of once~     weekly verses daily D-3 dosing regimens based on the most current IBD supplementation~     guidelines in improving 25(OH)D levels. A seconary aim is to determine if there is difference~     in adherence between dosing regimns.~   "
100133|NCT02256592|"~     Even in individuals treated for HIV, chronic immune activation persists and is associated~     with increased cardiovascular disease, liver disease, and mortality. HIV-infected individuals~     have imbalances in the community of intestinal microbes which is thought to contribute to~     increased and persistent inflammation. The purpose of this study is to examine the safety and~     durability of fecal microbiota transplant (FMT), the transfer of the bacterial community in~     stool from a healthy donor, in HIV+ individuals on anti-retroviral therapy. The study will~     also measure the effects of FMT on immune activation and inflammatory biomarkers in~     anti-retroviral treated HIV+ individuals.~   "
100134|NCT02256579|"~     This study is to investigate clinical utility of beta2 microglobulin as an early marker for~     renal dysfunction caused by Tenofovir in Vietnamese HIV-infected patients.~   "
100135|NCT02256566|"~     The purpose of this study is to investigate the effects of a computerized cognitive training~     program (an attention and memory exercise performed on a computer) on thinking and memory in~     individuals with mood and anxiety disorders, and to begin to test whether this training~     affects symptoms of depression or anxiety.~   "
100136|NCT02256553|"~     The purpose of this study is to assess the safety and tolerability of MK-3641 (short ragweed~     [Ambrosia artemisiifolia] extract, SCH 039641, RAGWITEK®) sublingual tablets and MK-7243~     (Timothy grass [Phleum pratense] extract, SCH 697243, GRASTEK®) sublingual tablets~     co-administered in participants 18 through 65 years of age with both ragweed- and grass~     polled-induced allergic rhinitis, with or without conjunctivitis and with or without asthma.~     The primary endpoint is the percentage of participants who experience at least one event of~     local swelling after co-administration of MK-3641 and MK-7243 sublingual tablets.~   "
100137|NCT02256540|"~     This pilot study plans to learn more about the aging of blood vessels and arteries in women.~     As women age and go through menopause, their risk for cardiovascular disease increases. Also~     with aging and menopause, levels of the reproductive hormone estradiol decline. Hormone~     replacement therapy to restore estradiol levels does not protect women from cardiovascular~     disease, so lifestyle changes, such as regular exercise, are recommended to reduce disease~     risk. However, there are differences between men and women in their response to exercise. In~     older men, exercise improves the health of their arteries, but in postmenopausal women,~     exercise does not provide this benefit. The purpose of this pilot study is to determine~     whether low estradiol levels in postmenopausal women are responsible for the poor vascular~     response to exercise. In this study the investigators will also test whether treatment with~     resveratrol, a plant compound found in red wine, improves postmenopausal women's response to~     exercise. The investigators hypothesize that acute treatment with estrogen or resveratrol~     will improve vascular responses to an acute bout of exercise.~   "
100138|NCT02256527|"~     Multicenter, retrospective registry to collect baseline, clinical, procedural, in hospital~     and 9-12 month follow-up data to compare major adverse cardiac events in patients receiving~     Promus Premier drug eluting stent to data already collected from the REWARDS-TLX Registry in~     which patients received either the Taxus Liberte or XIENCE V drug eluting stent.~   "
100139|NCT02256514|"~     The purpose of this study is to evaluate daily dosing of oral immunotherapy~     hepcortespenlisimut-L (V5) in patients with advanced stage of HCC not amenable to surgical~     intervention or with recurrent tumor after surgery.~   "
100140|NCT02256501|"~     According to the high morbidity and mortality of idiopathic Dilated CardioMyopathy (IDCM) in~     pediatric, new modality of treatment is emerging. There are some case reports of~     administration of stem cell therapy. The investigators design the first randomized clinical~     trial in this setting. The investigators enroll 32 pediatric IDCM patients in two groups (16~     pts. in each group including cell therapy and control). The investigators assess the safety~     and efficacy of intracoronary transplantation of autologous bone marrow derived mononuclear~     cells in this patients compared to control group.~   "
100177|NCT02256007|"~     This study designs and develops an evidence-based game approach that will enhance the~     investigators understanding and usability of electronic tools to measure cognitive and~     sensorimotor abilities in an inpatient rehabilitation stroke population.~   "
100143|NCT02256462|"~     Objectives: To examine the effect of drug level-based personalized treatment of adalimumab in~     children with Crohn's disease. Design: A prospective, randomized, open label study. Setting:~     Pediatric gastroenterology centers. Participants: Children 6 year to 17 years who are~     diagnosed with CD and are planned to receive adalimumab treatment. Main outcome measures:~     Pediatric Crohn's Activity Index (PCDAI) at 48 and 72 weeks. Secondary outcome measures:~     Corticosteroids free remission rates and on adalimumab at 48 and 72 weeks. The effect of~     routine adalimumab drug monitoring-based treatment on trough levels and anti-adalimumab~     antibodies during therapy.~   "
100144|NCT02256449|"~     A multicentre, observational, prospective device registry, with no control group, designed to~     evaluate the efficacy and safety of the bioresorbable coronary device, used according to the~     indications of use, in daily clinical practice in a consecutive number of patients undergoing~     PCI in de novo coronary artery lesions. A total of 1,500 patients are planned to be included~     in the registry.~   "
100145|NCT02256436|"~     Participants with metastatic or locally advanced/unresectable urothelial cancer that has~     recurred or progressed following platinum-based chemotherapy will be randomly assigned to~     receive pembrolizumab or Investigator's choice of paclitaxel, docetaxel, or vinflunine. The~     primary study hypotheses are that pembrolizumab will prolong Overall Survival (OS) and~     Progression-free Survival (PFS) compared to paclitaxel, docetaxel, or vinflunine.~      Effective with Amendment 15, eligible participants who were allocated to the Active~     Comparator arm and experienced disease progression will be provided with the opportunity to~     crossover to receive pembrolizumab 200 mg one time every three weeks (Q3W) for up to two~     years of treatment in the Crossover Phase of the study.~   "
100146|NCT02256423|"~     This is an open-label, randomised, 3-period, 3-sequence single-dose crossover study to~     determine the comparative pharmacokinetic profile of the Test Investigational Medicinal~     Product (IMP) Ibuprofen 200 mg soft gel capsule (lipid formulation) with that from the~     reference products Nurofen® 200 mg tablet and ibuprofen 200 mg soft gel capsule following~     single dose administration in healthy male and female subjects.~      The study comprises of a pre-study screen (within 14 days of the first dose), followed by 3~     Treatment Periods (1, 2 and 3) and a post study follow up (3 - 7 days after the last dose).~     Each Treatment Period is of 1 day in duration, from the afternoon before dosing (Day -1)~     until 12 hours (h) post-dose (Evening of Day 1). Study drug is administered on the morning of~     Day 1 following an overnight fast. PK samples will be collected pre-dose and up to 12 h~     post-dose (x15 samples) for the measurement of ibuprofen. Safety is evaluated at specified~     times throughout the study. There is at least 48 h between dose administrations.~   "
100147|NCT02256410|"~     Purpose of study is to test in a randomized controlled trial (RCT) the effects of the~     Nervomatrix device on various clinical outcomes of patients with low back pain, as well as~     its mechanisms of action.~   "
100148|NCT02256397|"~     The purpose of this study is to assess whether comprehensive care enhanced with new~     technology to optimize asthma care in the home (using both a special sensor to track inhaler~     use and a hand-held PIKO-1 device to assess patients' forced expiratory volume in the 1st~     second [FEV1]) is effective in reducing total days when medical treatment is given outside~     the home (in clinic, emergency department, or hospital) among children with severe asthma~     receiving comprehensive care.~   "
100149|NCT02256384|"~     The study will evaluate the performance of measuring respiration rate with the Respiratory~     Acoustic Monitoring (RAM).~   "
100150|NCT02256371|"~     A randomized double-blind controlled two centers study. The primary objective of this study~     will be to show a superiority of hypnosis over relaxation on pain intensity in patients with~     neuropathic pain.~   "
100151|NCT02256358|"~     Compare the effects of intravenous midazolam and ketamine on emergence agitation after~     sevoflurane anesthesia~   "
100152|NCT02256345|"~     This study will be performed to determine the safety, tolerability, and dose-response to~     inorganic nitrate on exercise capacity in HFpEF. There are two primary goals for this study:~        1. Determine the population-specific pharmacokinetics and dose of KNO3 that can be safely~          given to subjects with HFpEF.~        2. Determine if there is a dose-response effect of nitrate supplementation on exercise~          capacity, evidenced by peak oxygen consumption (peak VO2), and physiologic adaptations~          to exercise.~   "
100153|NCT02256332|"~     Effects of a plant based ingredient on blood glucose in Type II diabetes patients.~   "
100154|NCT02256319|"~     This clinical trial has been designed to study and compare changes in deep brain activity~     (field potentials) in Parkinson's disease (PD) patients while awake, and during sedation with~     dexmedetomidine or propofol. The recording is made through a deep brain stimulation (DBS)~     electrode implanted for PD management.~      The investigators hypothesize that dexmedetomidine produces fewer changes as compared to~     propofol, and that those changes are consistent and recognizable when compared to activity in~     patients not exposed to any sedation. Typification of those changes would in the future allow~     for patients to undergo this surgery comfortably while not compromising the quality of the~     recording and of the final clinical outcome. The principal variable analyzed is the signal's~     power in each of the frequency bands, absolute and relative. The analysis will include usual~     clinical methods such as rapid Fourier transform (FFT) and window fast Fourier transform~     (WFFT), wavelet analysis, Gabor, and coherence.~   "
100155|NCT02256306|"~     The PLasma for Alzheimer SymptoM Amelioration (PLASMA) Study: Intravenously-Administered~     Plasma From Young Donors for Treatment of Mild-To-Moderate Alzheimer's Disease~   "
100156|NCT02256293|"~     Individuals with diabetes often report that difficult thoughts and feelings about diabetes~     interfere with making healthy choices with regards to diabetes management. The purpose of~     this study is to evaluate a diabetes self-management group based on Acceptance and Commitment~     Therapy (ACT). ACT is a new behavior therapy that has been found to be useful in treating~     psychological and behavioral difficulties. We are interested in whether individuals with~     diabetes will like an ACT-based diabetes management group and whether they find the group~     helpful.~   "
100178|NCT02255994|"~     The main purpose of this study is to evaluate the long-term (5-8 years) functional prolapse~     recurrence rate of the 147 patients enrolled, randomized and analyzed in the study PRO-CURE~     I.~   "
100179|NCT02255981|"~     The purpose is to assess the efficacy of acupuncture (Traditional Chinese Medicine) for~     chronic macular diseases, and help to solve a problem for cases that have no treatment, no~     response to the conventional treatment, or have no access to medical treatment.~   "
100157|NCT02256280|"~     At the end of anesthesia it's important to avoid residual neuromuscular block to ensure~     adequate respiratory function preventing postoperative pulmonary complications. This trial~     compares the neuromuscular block reversal with different drugs (sugammadex vs neostigmine)~     after thoracic anesthesia. The trial main objective is to demonstrate that sugammadex is~     faster than neostigmine to reach a Train-of-four-Ratio (TOF-ratio) of 0.9 after thoracic~     anesthesia, demonstrating that sugammadex allows a faster extubation. Other main purpose is~     to verify if there is a difference between sugammadex and neostigmine as regards adverse~     events after extubation and in the postoperative period (until the 30th day after surgery).~      Note: TOF-ratio is defined as the ratio of the fourth muscular twitch/first twitch value~     during an accelerometric train-of-four stimulation.~   "
100158|NCT02256267|"~     The aim of this two-period study is to compare how much of the study drug gets into the blood~     stream when it is given as a single oral dose and when it is given as a single oral dose in~     combination with rifampin (a Food and Drug Administration [FDA] approved antibiotic that is~     used to treat tuberculosis, a bacterial infection that mainly affects the lungs, and other~     infections). Each participant will complete both study periods.~      The study will last about 34 days. Screening is required within 28 days before study drug is~     given.~   "
100159|NCT02256254|"~     The purpose of the study is to investigate if use of simvastatin is associated with the level~     of oxidative stress in humans. The association is examined by comparing changes in oxidative~     stress in a group treated with simvastatin with the change in a placebo group. The study is a~     randomized-based, double-blinded placebo-controlled study. Each treatment group consists of~     20 healthy male volunteers who consume simvastatin or placebo over 14 days. The induction of~     oxidative stress is measured by 8-oxoguanosine and 8- oxodeoxyguanosine, isolated from urine.~     A t-test will be performed to compare drug treatment with placebo. The results will be~     published.~   "
100160|NCT02256241|"~     Stage 1:~      Bone marrow will be collected from otherwise healthy patients undergoing orthopedic surgery -~     arthroplasty for the treatment of degenerative joint disease or traumatised patients. The~     bone marrow will be collected from disposable tissue that is removed during the normal~     sequence of the surgery. These cells will be used for:~      Establishment of the role of RING ubiquitin ligases in osteogenic progenitors proliferation~     and differentiation in culture.~      I. To determine the levels of RING ubiquitin ligases mRNA and protein in differentiating~     human mesenchymal precursor cells: To test the correlation between levels of RING ubiquitin~     ligases and degree of osteogenic differentiation, we will extract mesenchymal precursor cells~     from the collected tissue and test the mRNA protein level of RING ubiquitin ligases upon~     induction of differentiation. Specifically, we will compare the levels of RING ubiquitin~     ligases before and after the initiation of differentiational stimulus in time dependent~     manner by western blot and real time PCR analysis.~      II. To test the impact of specific RING ubiquitin ligases on differentiation of human~     mesenchymal precursor cells: to test the impact of RING ubiquitin ligases on the~     differentiation of mesenchymal precursor cell from the collected tissue by testing the~     expression of classical differentiational bone markers by flow cytometry (fibronectin, CD105)~     and by Alkaline phosphatase (ALP) activity assay. For this aim we developed both a~     constitutive and Dox-regulated conditional overexpression and shRNA lenti-viral systems that~     enables efficient modulation of these RING ubiquitin ligases level.~      III. Determine the role of RING ubiquitin ligases in proliferation and survival of human~     mesenchymal precursor cells: Via inhibition or overexpression of ligases in mesenchymal~     progenitor cells we will test the role of these ligases in proliferation and survival of~     mesenchymal precursors by using MTT assay, Propidion-Iodid (PI) and tunnel assays in flow~     cytometry analysis.~      Stage 2:~      Collection of connective tissue from patients with malignancies of musculoskeletal origin.~     The tissue that will be used is part of the resected tumor specimens. The tissue will be used~     for:~      The establishment of the role/s of RING ligases in musculoskeletal cancers using cell culture~     and in vivo activation. Test if the expression of selected positive candidates from stage 1~     correlates with cancer development and progression in human-derived samples Independently of~     our mechanistic experiment we aim to determine the relevance of these ligases to human~     musculoskeletal cancers. As the first step we will screen primary tumor biopsies at the~     protein level correlates with cancer grade and prognosis. Toward this aim we recently~     generated a highly specific several anti-monoclonal antibodies in our laboratory as well use~     comercial available antibodies .~   "
100161|NCT02256228|"~     Can perioperative administration of intra-peritoneal local anaesthetics further reduce~     postoperative pain, inflammation and outcome in patients undergoing major abdominal surgery~     (cytoreductive surgery) and managed with thoracic epidural analgesia? - Multicenter study.~   "
100162|NCT02256215|"~     Restless Legs Syndrome (RLS) is a sensorimotor disorder that syndrome may substantially~     interfere with normal sleep, leading to significant impairment in patients' productivity and~     quality of life.~      The most common and potent of all treatment regimens are the dopaminergic agonist agents,~     which carry serious adverse events in their prolonged use despite their augmentation. A few~     basic studies have suggested a potential relationship between vitamin D and RLS. It has been~     implicated that dopaminergic system dysfunction plays a role in the development of RLS, while~     vitamin D has a protective effect on that system. This has been further substantiated by few~     clinical observations that showed prompt improvement of RLS patients upon receiving~     dopaminergic agents such as carbamazepine. Other studies have revealed low serum levels of~     vitamin D in RLS patients, along with remarkable improvement after vitamin D replacement~     therapy, as has been demonstrated in a recent pilot study.~      This collectively points at vitamin D as a potential, more natural and safer treatment option~     for those suffering from RLS. However, the role of vitamin D in RLS has not been effectively~     investigated. The aim of this 12-week, triple-blinded, randomized, placebo-controlled trial~     is to confirm the relationship between vitamin D deficiency and RLS and hence elucidate the~     efficacy of vitamin D replacement therapy in reducing the severity of RLS, with predictions~     that the results will contribute to better understanding of the disease and its management.~      Methods and Materials: This 12-week, double-blinded, randomized, placebo-controlled trial is~     take place over a duration of 2 years. It will be held in the city of Jeddah to assess a~     sample of Saudi residents of the Western region.~      It is comprised of a number of visits, with the first one consisting of a questionnaire that~     is to be answered regarding RLS, physical examination, electromyography, the objective~     multiple Suggested Immobilization test, and blood tests. The main purpose of the second visit~     is to establish a diagnosis of RLS.~      Clinic visits number 3 through 6 comprise the pre-randomizaiton phase. Their purpose is to~     determine the patient's adherence to trial procedures and pharmacological treatment.~      Then, patients are to visit the clinic every two weeks for the first two months, then at week~     12. Patients will be assessed in regards to treatment response and adverse effects through~     history and physical examination along with further blood tests.~      Aim: to confirm the relationship between vitamin D deficiency and RLS and hence elucidate the~     efficacy of vitamin D replacement therapy in reducing the severity of RLS, with predictions~     that the results will contribute to better understanding of the disease and its management.~   "
100163|NCT02256202|"~     There are actually no standardized quality assurance procedures included in pain treatment~     processes.~      In this observational, feasibility study the use of tablet-Personal Computer (PC) is tested~     in pain therapy centres using the validated questionnaire Activity Index. The acceptance of~     electronic data capturing is tested in patients and therapy teams (doctors and nurses).~   "
100164|NCT02256189|"~     To evaluate the effect of DPP-4 inhibition on glucagon counter-regulatory mechanisms at~     moderate hypoglycemia in metformin-treated subjects with T2DM~   "
100165|NCT02256163|"~     The primary objectives of the study are~        -  to assess the contribution of alteration of each known gene on non-syndromic TAA.~        -  to map and identify unknown gene involved in the non-syndromic TAA.~   "
100166|NCT02256150|"~     To demonstrate that the treatment effect in lupus nephritis of MZR is non-inferior to that of~     standard therapy CTX through analyzing overall remission rate after treatment.~   "
100180|NCT02255968|"~     The primary objective of the study is to determine the safety and tolerability of multiple~     doses of orally administered EDP-788. Secondary objectives of the study are to describe the~     pharmacokinetics of EDP-788 (and its metabolite EDP-322) after multiple doses of orally~     administered drug.~   "
100181|NCT02255955|"~     Compare the analgesic effects of naproxen sodium codeine, paracetamol codeine and placebo on~     postoperative pain and tramadol (Contramal) consumption during the first 24 hour after a~     lumbar disk surgery.~   "
100167|NCT02256137|"~     Advances in cancer therapies have led to increasing numbers of adult survivors of pediatric~     malignancy. Unfortunately, treatment of childhood cancer continues to require agents designed~     to destroy malignant cell lines, and normal tissue is not always spared. While early~     treatment- related organ specific toxicities are not always apparent, many childhood cancer~     survivors report symptoms that interfere with daily life, including exercise induced~     shortness of breath, fatigue and reduced capacity to participate in physical activity. These~     symptoms may be a hallmark of premature aging, or frailty. Frailty is a phenotype most~     commonly described in older adults; it indicates persons who are highly vulnerable to adverse~     health outcomes. Frailty may help explain why nearly two thirds of childhood cancer survivors~     have at least one severe chronic health condition 30 years from diagnosis, why childhood~     cancer survivors are more likely than peers to be hospitalized for non-obstetrical reasons,~     and why they have mortality rates more than eight times higher than age-and-gender matched~     members of the general population.~      Frailty is a valuable construct because it can be distinguished from disability and~     co-morbidity, and is designed to capture pre-clinical states of physiologic vulnerability~     that identify individuals most at risk for adverse health outcomes. These investigators have~     recently presented data indicating that impaired fitness is present in survivors of childhood~     acute lymphoblastic leukemia, brain tumor and Hodgkin lymphoma. This is relevant because~     frailty, characterized by a cluster of five measurements of physical fitness, is predictive~     of chronic disease onset, frequent hospitalization, and eventually mortality in both the~     elderly and in persons with chronic conditions. Using a frailty phenotype as an early~     predictor of later chronic disease onset will allow identification of childhood and~     adolescent cancer survivors at greatest risk for adverse health. An early indicator of those~     at risk for adverse health will allow researchers to test, and clinicians to provide,~     specific interventions designed to remediate functional loss, and prevent or delay onset of~     chronic health conditions. The investigators goals include characterizing physical frailty~     over a five year time span in a population of young adult survivors of childhood cancer, as~     well as assessing the association between frailty and the increase in the number and severity~     of chronic health conditions.~   "
100168|NCT02256124|"~     The purpose of this study is to determine whether lamotrigine can improve cognitive and~     neurophysiological deficits in adolescents with Neurofibromatosis type 1.~   "
100169|NCT02256111|"~     This study will examine the effect of supervised exercise training on cardiopulmonary~     function in men receiving the combination of enzalutamide (ENZ) and androgen deprivation~     therapy (ADT) for treatment of non-metastatic, hormone-naïve prostate cancer. No study to~     date has examined the efficacy, tolerability, and safety of exercise training to prevent~     and/or mitigate common adverse toxicities in men receiving combination androgen suppression~     therapy for hormone-naïve prostate cancer.~   "
100170|NCT02256098|"~     The PFC Sigma Knee by DePuy Synthes is an excellent knee replacement with an excellent~     clinical track record, good survival rates (98% 10 years survival in patients aged < 55~     years)(Keenan et al., 2012) and minimal early migration as measured with RSA (0.5mm MTPM at~     two years follow-up)(von et al., 2009).~      The ATTUNE™ Knee by DePuy Synthes is an advancement in knee replacement options. It is~     designed to provide better range of motion and address the unstable feeling some patients~     experience during everyday activities, such as stair descent and bending. To date (March~     2013), more than 3,500 patients have received an ATTUNE Knee as part of a limited launch and~     positive feedback was received regarding patient recovery, stability and motion.~      The objective of this study is to accurately assess and compare migration, clinical and~     radiological outcome and patient reported outcomes of two TKR prostheses: the Cemented~     ATTUNE™ Fixed Bearing Cruciate Retaining Knee System and the Cemented PFC Sigma Fixed Bearing~     Cruciate Retaining Knee System, both by DePuy Synthes, Warsaw, Indiana, USA. The primary~     objective of this study is to compare the magnitude and pattern of migration of the~     prostheses (Femoral and Tibial component). The secondary objective of this study is to~     compare clinical and radiological outcome of the prostheses and PROMS. The tertiary objective~     of this study is to compare clinical and radiological outcome and PROMS of the prostheses~     with migration data.~      This study is designed as a single-blind, randomized trial between the ATTUNE™ Knee System~     and PFC Sigma Knee System. 32 patients with the ATTUNE™ Knee System and 32 patients with PFC~     Sigma Knee System will be included in this study.~      The study population will consist of patients with symptomatic osteoarthritis of the knee~     scheduled for TKR surgery at the Department of Orthopaedics, Medisch Centrum Haaglanden, The~     Hague, The Netherlands. Annually 300 TKA procedures are performed in this department, of~     which about 90% is Osteo Arthritis (OA) and 10% Rheumatoid Arthritis (RA) and other~     indications. We anticipate that inclusion can be accomplished within a 1 year period and that~     the total study duration is 3 years.~      Main study parameters/endpoints are:~        -  Migration of the prosthesis with respect to the host bone measured by means of roentgen~          stereophotogrammetric analysis (RSA).~        -  Patient Reported Outcome Measures by means of questionnaires.~   "
100171|NCT02256085|"~     This is a randomized controlled trial (RCT) on the efficacy of repetitive Transcranial~     Magnetic Stimulation (rTMS) in the treatment of Depersonalization Disorder (DPD). TMS applies~     a magnetic field to the brain for a brief period of time. TMS is a procedure that involves 30~     minute-long daily sessions every weekday for a series of weeks. The investigators are testing~     whether TMS can treat Depersonalization Disorder (DPD).~   "
100172|NCT02256072|"~     The goal of this study is to develop and test an advance planning tool to help seniors~     understand projected health needs and plan ways to remain in their own homes when these~     crises occur. In this phase of the study through partnerships with seniors, senior community~     groups, area agencies on aging, and home care agencies the investigators are conducting a~     two-armed (attention control and intervention) randomized controlled trial.~      Individuals will be randomly assigned to one of two interventions: attention control or the~     advance planning tool. The investigators attention control group will control for the~     possibility that regular contact with the study team may improve outcomes in participants~     randomized to the intervention website. Participants in the attention control arm will~     navigate an electronic educational session via a National Institute on Aging at NIH Web site~     about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15~     minutes and a maximum of 45 minutes will be allotted for navigating the Web site. The Web~     site is interactive and comparable to the intervention tool:~     http://go4life.nia.nih.gov/get-started).~      If randomized to intervention, subjects will be introduced to the advance planning tool, the~     Plan Your Lifespan website, and given instructions on how to use it. Plan Your Lifespan is a~     Web-based planning tool that provides information for seniors related to advanced health~     planning for home services in specific content areas of: hospitalizations, falls,~     Alzheimer's, dementia, as well as communicating with others. The Plan Your Lifespan website~     is also interactive in that it allows participants to enter their information and share it~     with others to facilitate conversations and decision-making. Participants will navigate and~     complete the Web-based advance planning tool and will be allotted a minimum of 15 minutes and~     a maximum of 45 minutes to navigate the tool as part of the study.~      All participants will be administered a pre- and post-test before and after viewing the~     website they were randomized to. All participants will be followed up at one and three months~     post via a brief phone call where follow-up questions will be asked of all participants.~   "
100173|NCT02256059|"~     Treatment of lateral fractures of the clavicle is challenging and has been controversially~     discussed for a long time due to high non-union rates in non-operative treatment and high~     complication rates in surgical treatment. A recently developed implant was proven to ensure a~     biomechanically sufficient fixation of fractures leading to bony union and promising~     functional outcome in a small collective of patients.~   "
100174|NCT02256046|"~     Aim of this thesis is to predict the incidence of esophageal ulcer bleeding after endoscopic~     management of esophageal varices.~      This study will be in the department of Tropical Medicine and Infectious Diseases, Tanta~     University, in at least six months in the period from august 2014 to march 2015 or until the~     target number of patients reached whichever is longer.~   "
100175|NCT02256033|"~     The purpose of this study is to test whether mild liver impairment affects blood levels of~     istradefylline in humans. Decreased liver function could possibly increase istradefylline~     levels.~   "
100176|NCT02256020|"~     Investigators anticipate to develop a customized WC-MAE for the improvement of insomnia and~     depression in wheel-chair dependent elders, and to identify related mechanisms as biomarkers~     for prediction and prevention of insomnia and depression in elders with physical disability~     in long term care facilities.~   "
104782|NCT02195869|"~     The purpose of this study is to assess the safety and clinical efficacy of ibrutinib in~     subjects with steroid dependent or refractory Chronic Graft Versus Host Disease.~   "
100187|NCT02255877|"~     Study designed to evaluate the Zip Surgical Skin Closure device versus conventional steel~     staple placement when utilized for surgical wound closure after bi lateral unicompartmental~     or bi later total knee replacement.~   "
100188|NCT02255864|"~     The purpose of this study is to evaluate the safety and performance of a new coronary artery~     stent for treating blockages in the arteries supplying blood to the heart muscle. The~     Amaranth FORTITUDE scaffold releases a drug (sirolimus) to reduce the likelihood of the~     treated blood vessel developing a new blockage. In addition, the scaffold dissolves away over~     time, leaving no permanent implant after the blood vessel has healed.~   "
100189|NCT02255851|"~     The SENTINEL Post-Market Registry is a prospective, multi-center, registry using the~     CE-Marked Sentinel System in subjects with severe symptomatic calcified native aortic valve~     stenosis indicated for TAVR.~      Subjects enrolled in the registry will undergo TAVR + Sentinel. Basic demographic information~     and detailed procedural data will be captured and documented in a registry case report form.~      All Sentinel filters will be sent for histopathology at an independent core-lab.~   "
100190|NCT02255838|"~     Flexible bronchoscopes are typically reusable and therefore need high level disinfection to~     prevent inadvertent spread of microbial pathogens from patient to patient. The process of~     disinfection is time consuming and expensive. Moreover, a bronchoscope being processed may~     not be readily available for another patient. One solution to this problem was to use a~     single use disposable sheath that covers a flexible bronchoscope protecting all surfaces of~     the bronchoscope.(Colt, Beamis, Harrell, & Mathur, 2000). Another way to eliminate potential~     hazards with a reusable bronchoscope is the use of a disposable bronchoscope. Such a~     disposable bronchoscope has been developed (Ambu aScope, Ambu, Glen Burnie, MD) and has been~     used successfully for intubations in manikins(Scutt et al., 2011) and patients. (Kristensen &~     Fredensborg, 2013; Pujol, López, & Valero, 2010; Tvede, Kristensen, & Nyhus-Andreasen, 2012).~     Further advancement in the imaging and handling of this disposable flexible bronchoscope now~     allows for the purpose of bronchoscopy and broncho-alveolar lavage in critically ill patients~     with pulmonary compromise. (FDA approval: 05-11-2013 date)~      The aim of the study is to compare image clarity, suction capacity, and handling performance~     of a reusable flexible bronchoscope to the disposable flexible bronchoscope. In addition, the~     investigators intend to perform a cost analysis.~   "
100191|NCT02255825|"~     To gain knowledge about how patients undergoing prenatal diagnosis for a fetal abnormality~     understand and react to Whole Genome Sequencing (WGS) testing, so that the investigators can~     develop more ethical and responsible approach to patient education, counseling, and return of~     results for patients.~   "
100192|NCT02255812|"~     Taste physiology describes five main taste qualities in humans: sweet, sour, salty, umami and~     bitter. The receptors found on the tongue are also found in the entire gut. The correlation~     of stimulation of these gut receptors and brain activity has not yet been examined. The~     objectives are to investigate the effect of different taste substances on i) regional brain~     activity and ii) satiation peptide release.~   "
100193|NCT02255799|"~     This is a four-site, randomized, parallel design, double-blind, placebo-controlled, 10-week~     trial of donepezil 10 mg daily for verbal memory problems among adults with TBI in the~     subacute or chronic recovery period. The study will recruit 160 persons with TBI and~     functionally important memory problems during a four-year period of open recruitment.~      The study aims are:~        1. To evaluate the effects of treatment with donepezil on verbal memory as assessed by the~          Hopkins Verbal Learning Test-Revised Total Trial 1-3;~        2. To evaluate the effects of treatment with donepezil on memory-related activities as~          measured by the Everyday Memory Questionnaire;~        3. To evaluate the effects of donepezil on attention, processing speed, neuropsychiatric~          symptoms, community participation, quality of life, and caregiver experiences.~   "
100194|NCT02255786|"~     The investigators will develop and pilot test an intervention called ACT for Parents which~     aims to decrease stress and improve quality of life in parents of children < 15 years who~     have a diagnosis of autism spectrum disorder. A small randomized trial testing phase will be~     conducted to gather initial data on the treatment feasibility and acceptability, detect~     treatment effects between groups (ACT for Parents versus Treatment as Usual), and to refine~     the treatment design for a future clinical trial.~   "
100195|NCT02255773|"~     The goal of this research study is to learn more about fatigue and how it affects your~     behavior as well as your willingness to learn new behaviors.~   "
100196|NCT02255760|"~     This is a Phase 1, randomized, double-blind, placebo-controlled, dose escalation study~     evaluating the safety and tolerability of a single ascending IV dose of MEDI3902 in healthy~     adult subjects 18 to 60 years of age.~   "
100197|NCT02255747|"~     This study is to evaluate the effect of anal dilation in infants and children with~     constipation.~   "
100198|NCT02255734|"~     Bioequivalence of two formulations of Acyclovir (Acyclovir Lyophilized I.V. infusion 250mg)~     after Intravenous Infusion in Healthy Volunteers.~   "
100199|NCT02255721|"~     The SHIP study is a randomized controlled trial of an intervention for preschool children~     with sleep problems, in which we aim to give parents the knowledge, motivation, and skills~     necessary to set goals, problem-solve, and improve their child's sleep. In collecting three~     years of follow-up data, we will be able to determine the impact of the SHIP intervention on~     childhood sleep problems, obesity, academic achievement, and emotional and behavioral~     problems, as well as parental stress and daytime tiredness. This study has the dual potential~     to expand treatment resources for young children with behavioral sleep problems and to~     increase our scientific understanding of the long-term consequences of early childhood sleep~     problems.~   "
100200|NCT02255708|"~     The present study aims to assess through surface electromyography, the effectiveness of~     proprioceptive neuromuscular facilitation protocols in the activation of the stabilizing~     muscles of the scapula and the anterior tibial muscle.~   "
100230|NCT02255305|"~     The purpose of the study is to determine the safety and efficacy of Fecal Microbiota~     Transplant (FMT) for the treatment of the recurrence of Clostridium difficile infection (CDI)~     as compared to standard antibiotic therapy. Patients who have tested positive for CDI within~     90 days of an admission for relapse of CDI will be approached to participate in this~     open-label, randomized controlled trial. Patients will either be randomized to the~     intervention group (receive FMT via retention enema) or the control group (receive~     antimicrobials targeting CDI).~   "
104783|NCT02195856|"~     Rationale:~      Mediterranean style diets and diets rich in green leafy vegetables protect against the risk~     of developing type 2 diabetes and a wide range of cardiovascular disease. These diets are~     rich in nitrate. Numerous studies have shown that nitrate from the diet can have a wide range~     of beneficial effects. These include relaxing blood vessels and improving their function. It~     has been shown that following a meal with added nitrate, blood flow to the stomach increases~     more than would be expected if the same meal is given without nitrate. This is because when~     we eat nitrate the body concentrates it and recycles it through the digestive system. As it~     cycles through it is converted into nitrite and nitric oxide which cause blood vessels to~     relax. The nitrite and nitric oxide also seem to protect against infection from food sources~     such as E.coli.~      What we do not know is whether this nitrite and nitric oxide has any effect on the small~     intestine and the liver. Some nitrite reaches the small intestine and may have the same~     effect on blood flow there as it does in the stomach. This could be very important because~     the small intestine releases hormones called incretins which we now know play a very~     important role in controlling blood sugar every time we eat. These incretin hormones regulate~     insulin release and the body's sensitivity to insulin. When we eat blood containing the~     substances we have absorbed from the gut, such as sugars and fats, goes to the liver for~     processing. The blood then leaves the liver and enters the circulation. This means the blood~     supply to the liver will have much higher concentrations of nitrite than the blood~     circulating in the rest of the body. High concentrations of nitrite appear to cause blood~     vessels to open up. This means more blood vessels in the liver should be opened after a~     nitrate rich meal. It seems likely that this will help the liver to control blood sugar more~     effectively.~      Purpose To find out if supplementation by inorganic nitrate as found in beetroot or green~     leafy vegetables increases liver (hepatic) microvascular perfusion and increases incretin~     secretion.~      Plan of investigations:~      We will recruit 16 individuals for each of the three groups (Young adults, older adults and~     individuals with type 2 diabetes). Participants will be recruited from a database of~     volunteers who have consented to being contacted for research studies which are held by the~     NIHR Exeter Clinical Research Facility. This is a double blind, placebo controlled crossover~     design study (nitrate rich beetroot juice vs a placebo, nitrate depleted beetroot juice).~     Three visits will be required for participants to complete this study.~      Visit 1. Screening and consent. The experimenter will explain to the participant what the~     study is designed to test. If the participant is completely clear on the study and understand~     what they are agreeing to, they will sign a consent form. In addition a standard medical~     history and clinical examination will be undertaken by a research nurse and or Anthony~     Shepherd. A venous blood sample will be taken using standard aseptic procedures. Following~     consent participants will be assigned a study number. Study numbers will be previously~     assigned (by a research statistician) to a randomisation order to begin either the beetroot~     juice or placebo arm of the study first.~      Visit 2. Visit 2 will require the participant to fast over night from 10pm. Only water will~     be admissible from this time. The following morning participants will arrive at the~     laboratory in a fully hydrated and rested state at ~ 7.30am. This visit will take ~ 5 hours~     and will require 4 MRI scans. Participants will have the first MRI scan after a short~     acclimatisation period. Participants will then be provided with a concentrated 140 mL nitrate~     drink or placebo with a standardised breakfast (2 slices of toast with butter). Three~     subsequent MRI scans will be required (one per hour for three hours). Venous blood samples~     taken from cannulas will be sampled, in order to assess glucose, insulin, incretins and~     nitrate/nitrite prior to each scan. Visit 3. Visit 3 will take place after a minimum washout~     period of 7 days from Visit 2. Visit 3 will be identical in nature to visit 2; however, it~     will be with the opposite supplement (either nitrate rich or placebo beetroot juice).~      Impact:~      Dietary nitrate appears to offer a simple, low cost means of modifying cardiovascular risk.~     This study will deepen our understanding of the role of the nitrate/nitrite/nitric oxide~     pathway in normal physiology. By understanding what effect inorganic nitrate from the diet~     has on hepatic perfusion and other pathways involved in glucose homeostasis this may lead to~     a range of simple, low cost therapeutic strategies to prevent and treat type 2 diabetes.~   "
100201|NCT02255695|"~     The objective of this study was to evaluate the effects of a school-based exercise program on~     posture, trunk range of motion and musculoskeletal pain in schoolchildren. This study was a~     Randomized controlled trial. The hypothesis was that the exercise group would have the~     postural deviations corrected, would have the trunk range of motion increased and would have~     the prevalence of pain decreased, while the control group would have not. Three schools from~     Brazil participated. The students that have been included (n=300) were randomly allocated to~     experimental (EG) or control group (CG). The intervention for EG consisted in a program based~     on stretching and strengthening exercises, applied twice a week, for eight weeks, with group~     sessions of 50 minutes. CG did not perform any intervention. Qualitative and quantitative~     postural evaluation (PAS/SAPO), musculoskeletal pain (self-report) and trunk mobility were~     collected.~   "
100202|NCT02255682|"~     Background Statins are cholesterol lowering drugs that are prescribed to lower the risk of~     cardio-vascular diseases. The use of statins has increased markedly and it is now one of the~     most prescribed drugs in the world. 600,000 people in Denmark are taking statins on a daily~     basis, 40 % of these are taking the medication without having any other risk factors for~     cardio-vascular diseases than elevated blood-cholesterol i.e. they are in primary prevention.~      Statins are not without side effects and studies have shown that there is an elevated risk of~     developing diabetes when taking statins. This has led to an increased debate about the use of~     statins in primary prevention. Furthermore a large meta-analysis has shown that to prevent~     one event of cardio-vascular disease, it is necessary to treat 200 people for 3-5 years.~     These data suggest that more conservative use of statins to prevent CVD in otherwise healthy~     individuals at low risk for future CVD may be warranted.~      Other side effects of statins are muscle myalgia, muscle cramps and fatigue which potentially~     can prevent a physically active lifestyle. The biomedical background of these side effects is~     not fully elucidated but it has been shown that there is a link to decreasing levels of an~     important enzyme, Q10, which plays a role in muscle energy metabolism.~      Hypothesis~      The overarching research question is: why does statin treatment cause muscle pain? Does~     statin treatment impair (or even prevent) physical exercise training? Furthermore we would~     like to answer the following questions:~        1. Does statin treatment impair (or even prohibit) physical exercise training?~        2. Does statin treatment cause:~             -  Decreased muscle strength?~             -  Skeletal muscle inflammation?~             -  Decreased mitochondrial respiratory function?~        3. Abnormal glucose homeostasis?~   "
100203|NCT02255669|"~     The purpose of this study is to compare the duration of stent patency between partially~     covered and fully covered SEMS for palliation of malignant distal bile duct obstruction.~   "
100204|NCT02255656|"~     Primary Objective:~      To evaluate long-term safety of alemtuzumab.~      Secondary Objectives:~        -  To evaluate long term efficacy of alemtuzumab.~        -  To evaluate the safety profile of patients who received other Disease Modifying~          Treatment's (DMT) following alemtuzumab treatment.~        -  To evaluate patient-reported Quality of Life (QoL) outcomes and health resource~          utilization of patients who received alemtuzumab.~        -  To evaluate as needed re-treatment with alemtuzumab and other DMTs.~        -  To develop biomarkers predictive of autoimmune conditions including thyroid disorders~          and immune thrombocytopenia. This will include collection of samples from patients who~          have not yet developed any auto immune conditions; these samples would be used as~          controls.~        -  To explore efficacy and safety markers through data analysis.~        -  To explore genetic variation related to MS disease manifestation through data analysis.~   "
100205|NCT02255643|"~     Motor cortex stimulation (MCS) is a form of brain stimulation for patients with neuropathic~     pain not responsive to medication. An electrode is placed on the surface of the brain and~     connected to a programmable battery in the chest.~      The strength of stimulation can be individually adjusted by changing the voltage of~     stimulation. A too high voltage will produce side effects (e.g. seizures) while a too low~     voltage will not provide pain control. The aim of this study is to analyze the optimal~     stimulation parameters in patients already implanted with a motor cortex stimulation who have~     received good pain relief. The actual voltage may vary widely between patients but the~     investigators feel that there may be an ideal voltage if it is measured as a percentage of~     motor threshold (PMT). If motor threshold is the stimulation voltage that can evoke a muscle~     contraction then a PMT = 80% would be a voltage that was eighty percent of that value.~     Although the actual voltage may be widely different between patients, the percentage needed~     may be very similar. The investigators therefore plan to measure the effect of different~     percentages of PMT in patients already being treated with motor cortex stimulation.~      Systematic analysis of the findings of this study might help the individual participant and~     future patients to better programming and less side effects.~   "
100206|NCT02255630|"~     Athletes using inhaled β2-adrenoreceptor agonists (IBAs) win a disproportionate number of~     medals. However, most previous research has shown that β2 agonists do not improve exercise~     performance in either asthmatic or non-asthmatic athletes. Although the majority of these~     studies do not show an ergogenic effect, the small number of studies with extended exercise~     bouts (~60 minutes) do show an advantage. The investigators believe that a controlled yet~     sport-specific exercise protocol will elucidate this ergogenic effect. Because IBAs may have~     different effects on these two groups of athletes, the investigators will measure exercise~     performance in both female and male elite cyclists. The investigators hypothesize that~     athletes will perform better during a combination steady-state/sprint exercise task following~     salbutamol administration.~   "
100207|NCT02255617|"~     The purpose of this study is to determine if FMT can reverse Hepatic Encephlopathy (HE) in~     cirrhotic patients who continue to have breakthrough episodes of HE despite maintenance~     therapy with lactulose and/or rifaximin or metronidazole.~   "
100208|NCT02255604|"~     The investigators want to investigate whether specific immunotherapy can be delivered~     directly into a lymph node. The investigators think that a direct introduction of allergen to~     the antigen presenting cells in the lymph node a give a strong immune response and that this~     can change the number of injections needed in allergen immunotherapy. The investigators do~     measurements of clinical effect and a variety of paraclinical test to see if the~     investigators can find af biomarker of successful specific immune therapy of grass allergy.~   "
100231|NCT02255292|"~     Increasing lines of evidence support an antitumourigenic effect of cannabinoids, including~     the cannabidiol (CBD) which does not posses the psychotropic effects of~     D9-tetrahydrocannabinol (THC). These include anti-proliferative and pro-apoptotic effects and~     they are known to interfere with several mechanisms in the tumorgenesis. Yet, evidence from~     clinical trials among cancer patients is needed. The aim of the current study is to evaluate~     the impact of CBD as single treatment among cancer patients.~   "
100291|NCT02254499|"~     Despite improvements in treatment, a significant part of patients have severe pain following~     knee arthroplasty. Preoperative identification of high-risk patients would allow for an~     intensive individualized analgesic treatment pre- and postoperatively and thus potentially in~     reduced pain acute and chronically.~   "
100209|NCT02255591|"~     The main objective of the trial is to complete a double-blinded randomized controlled trial~     of a lumbar plexus block with the Shamrock technique versus the Lumbar Ultrasound Trident~     technique by estimating the time of performance of lumbar plexus blocks in healthy~     volunteers.~      Secondary objectives include a) estimates of number and depth of needle injections, distance~     of injection site from the midline, minimal electric nerve stimulation to trigger muscular~     response and the type of response, and volunteer discomfort during block injection, b)~     measurements of plasma lidocaine and mean arterial blood pressure, c) examinations of sensory~     block of the dermatomes T8-S3 and motor block of the femoral nerve, the obturator nerve, the~     hip abductor muscles, and the hamstring muscles, d) success rate of lumbar plexus block, e)~     perineural and epidural distribution of local anesthetics added contrast visualized on~     magnetic resonance imaging (MRI) scanning, and f) cost-effectiveness for the Shamrock~     technique versus the Lumbar Ultrasound Trident Technique for lumbar plexus block in healthy~     volunteers.~      The hypothesis is that the Shamrock technique is faster to perform than the Lumbar Ultrasound~     technique, and that the success rate of the Shamrock technique is equal to or higher than the~     Lumbar Ultrasound Trident technique.~   "
100210|NCT02255578|"~     Women with Polycystic ovary syndrome (PCOS) experience multiple fertility treatments, a long~     treatment duration and a low pregnancy prevalence. This syndrome is frequently accompanied by~     overweight and insulin resistance which can mediate the limited response to fertility~     treatment. The Endobarrier device was shown to be efficient in weight and glucose lowering.~     The aim of this study is to investigate the ability of the Endobarrier device to improve the~     outcome of fertility treatments in women with PCOS.~   "
100211|NCT02255565|"~     The purpose of this study is to determine whether Quillivant XR is effective in the treatment~     of ADHD in children with Autism Spectrum Disorder (ASD).~   "
100212|NCT02255552|"~     The main objective of this study is to provide evidence of efficacy of eteplirsen (AVI-4658)~     in Duchenne muscular dystrophy (DMD) patients that are amenable to skipping exon 51.~     Additional objectives include evaluation of safety, biomarkers and the long-term effects of~     eteplirsen up to 96 weeks, followed by a safety extension (not to exceed 48 weeks).~   "
100213|NCT02255526|"~     This project will compare BodyGuardian (BG) device measurements of breathing and activity~     levels to the gold standard measurement techniques of gas exchange using a mouthpiece~     connected to flow and gas analyzers measures for breathing and metabolic rate (indirect~     calorimetry) for activity, We are hopeful these comparisons will help us improve upon the~     measurements being made in the current version of the BG device.~   "
100214|NCT02255513|"~     This study will examine the efficacy and safety of HLD200 (methylphenidate) in patients age~     6-12 years with ADHD. This study has a 6-week dose optimization period followed by a one week~     double blind randomization assessment.~   "
100215|NCT02255500|"~     The purpose of this study is to evaluate the safety and pharmacokinetics of EXPAREL in~     subjects who undergo femoral nerve block with bupivacaine HCl for unilateral total knee~     arthroplasty (TKA).~   "
100216|NCT02255487|"~     This is a Phase IV study designed to evaluate rate of Surgical Site Infections (SSIs) when~     the IrriSept device is used in an open abdominal laparotomy for abdominal trauma or acute~     surgical abdomen. Half of the eligible subjects will be randomized to receive the IrriSept~     device and half of the subjects will receive the respective institution's Standard of Care~     (SoC).~   "
100217|NCT02255474|"~     This study will evaluate the use of two different bifocal contact lens add powers to prevent~     further nearsighted progression in children ages 7 to 11 years old. It is theorized that the~     profile of the bifocal lenses will decrease the amount of change in nearsightedness that the~     children experience.~   "
100218|NCT02255461|"~     This phase I trial studies the side effects and best dose of palbociclib isethionate in~     treating younger patients with central nervous system tumors that have grown, come back, or~     not responded to treatment. Palbociclib isethionate may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth.~   "
100219|NCT02255448|"~     Cardiac output (CO) is the volume of blood ejected from the heart and is a product of stroke~     volume (SV) vs heart rate (HR). It is closely related to Blood Pressure (BP) by the formula~     CO = Mean Arterial Pressure (MAP) / Systemic Vascular Resistance (SVR). Cardiac output~     monitoring is well established and validated for guiding fluid administration and~     resuscitation in intensive care and perioperatively in the non-pregnant population. Available~     CO monitoring methods may risk maternal health or fetal wellbeing or are unvalidated in the~     pregnant population. Invasive and semi-invasive methods of measuring CO such as the pulmonary~     artery catheter, the 'gold standard' require invasive arterial or central access negating~     their use in all but a select group of labouring women and have potentially serious risks~     attached to their usage. Echocardiography is a well-established and validated technique~     requiring no invasive access but the requirement for an experienced operator limits routine~     usage. It uses an external ultrasound probe to scan the heart.~      Several novel non-invasive cardiac output monitors have recently come to the market including~     the estimated cardiac output esCCO monitor (Nihon Kohden) which uses Pulse Wave Transit Time~     (PWTT) to estimate cardiac output. It requires 3-lead Electrocardiography and pulse oximetry~     alone which is part of the routine monitoring for high risk patients on the labour ward.~      The investigators research aims to evaluate the accuracy and precision of the esCCO in~     pregnant women and subsequently assess its utility during medical interventions such as~     epidural analgesia or caesarean section. The initial validation will take place in an~     antenatal clinic where women are assessed using Doppler echocardiography. The investigators~     will then compare the echocardiography results vs the esCCO results.~   "
100232|NCT02255279|"~     The administration of adjuvanted Trivalent Influenza Vaccine (aTIV) has come to result in a~     more immunogenic and effective response compared with conventional influenza vaccines in~     elderly and adults.~      The aim of this study is to evaluate safety and immunogenicity of Novartis aTIV in children 6~     to <72 months of age, Mexican population, in comparison to Fluzone, a non-adjuvanted~     trivalent influenza vaccine (TIV).~   "
100233|NCT02255266|"~     This study is conducted in Europe. The aim of this study is to investigate Long-Term~     Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in daily Practice.~   "
100329|NCT02254005|"~     Maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of bivatuzumab mertansine~   "
100220|NCT02255435|"~     Friedreich's ataxia is an autosomal recessive cerebellar ataxia caused by triplet-repeat~     expansions. The causative mutation is a trinucleotide (GAA) repeat expansion in the first~     intron of the frataxin gene, leading to impaired transcription of frataxin. The pathological~     consequences of frataxin deficiency include a severe disruption of iron-sulfur cluster~     biosynthesis, mitochondrial iron overload coupled to cellular iron dysregulation, and an~     increased sensitivity to oxidative stress.~      A hallmark of Friedreich's ataxia is impairment of antioxidative defense mechanisms, which~     play a major role in disease progression. Studies have demonstrated that nuclear factor~     erythroid-derived 2-related factor 2 (Nrf2) signaling is grossly impaired in patients with~     Friedreich's ataxia. Therefore, the ability of omaveloxolone (RTA 408) to activate Nrf2 and~     induce antioxidant target genes is hypothesized to be therapeutic in patients with~     Friedreich's ataxia.~      This 2-part study will evaluate the efficacy, safety, and pharmacodynamics of omaveloxolone~     (RTA 408) in the treatment of patients with Friedreich's ataxia.~      Part 1: The first part of this study will be a randomized, placebo-controlled, double-blind,~     dose-escalation study to evaluate the safety of omaveloxolone (RTA 408) at various doses in~     patients with Friedreich's ataxia.~      Part 2: The second part of this study is a randomized, placebo-controlled, double-blind,~     parallel-group study to evaluate the safety and efficacy of omaveloxolone (RTA 408) 150 mg in~     patients with Friedreich's ataxia. Patients enrolled in Part 2 will be randomized 1:1 to~     receive omaveloxolone (RTA 408) 150 mg or placebo.~      Extension: The extension will assess long-term safety and tolerability of omaveloxolone (RTA~     408) in qualified patients with Friedreich's ataxia following completion of Part 1 or Part 2.~     Patients will not be unblinded to study treatment in Part 1 or Part 2 upon entering the~     extension study. Patients will receive open-label omaveloxolone (RTA 408) at 150 mg once~     daily.~   "
100221|NCT02255422|"~     Mitochondrial myopathies are a multisystemic group of disorders that are characterized by a~     wide range of biochemical and genetic mitochondrial defects and variable modes of~     inheritance. Currently there are no effective treatments for this disease. Despite the~     heterogeneous myopathy phenotypes, a unifying feature of mitochondrial myopathies is that the~     pathogenic mtDNA mutations and/or nuclear mutations of the electron transport chain~     invariably lead to dysfunctional mitochondrial respiration. This reduction in mitochondrial~     respiration leads to a reduced ability to produce cellular adenosine triphosphate (ATP),~     often resulting in muscle weakness, exercise intolerance, and fatigue in patients with~     mitochondrial myopathies.~      RTA 408 is a potent activator of Nrf2 and inhibitor of NF κB (nuclear factor~     kappa-light-chain-enhancer of activated B cells), and thus induces an antioxidant and~     anti-inflammatory phenotype. Several lines of evidence suggest that Nrf2 activation can~     increase mitochondrial respiration and biogenesis. Collectively, available data suggest that~     the ability of RTA 408 to activate Nrf2 and induce its target genes could potentially improve~     muscle function, oxidative phosphorylation, antioxidant capacity, and mitochondrial~     biogenesis in patients with mitochondrial myopathies.~      Part 1: The first part of this study will be a randomized, placebo-controlled, double-blind,~     dose-escalation study to evaluate the safety of omaveloxolone (RTA 408) at various doses in~     patients with mitochondrial myopathies.~      Part 2: The second part of this study is a randomized, placebo-controlled, double-blind,~     parallel study to evaluate the safety, efficacy, and pharmacodynamics of up to 2 dose levels~     of omaveloxolone (RTA 408) in patients with mitochondrial myopathies. Eligible patients in~     Part 2 will be randomized 1:1:1 to receive omaveloxolone (RTA 408) (at one of 2 doses chosen~     from Part 1), or placebo.~   "
100222|NCT02255409|"~     Safety, Immunogenicity of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared~     to Non-Adjuvanted Comparator Influenza Vaccine in Children Previously Vaccinated in Trial~     V118_05~   "
100223|NCT02255396|"~     Estradiol and Testosterone are two important hormones for the regulation of an effective~     spermatogenesis in human testis. The evaluation of levels of estradiol and testosterone in~     seminal plasma of men with non-obstructive azoospermia may be a predictive test before~     surgical testicular biopsy to determine the chance of a positive sperm extraction to use for~     ICSI.~   "
100224|NCT02255383|"~     The primary objective of this study is to obtain implant survivorship and clinical outcomes~     data for commercially available Persona fixed bearing knee implants used in total knee~     arthroplasty. The assessment will include implant survivorship and clinical performance.~   "
100225|NCT02255370|"~     Curcumin, the active ingredient of turmeric, has been used for long term in the treatment of~     inflammatory conditions. Inhibition of NF-κB is postulated as the main mechanism responsible~     for the anti-inflammatory effect of curcumin~      Aim : to study the effect of curcumin, 3g per day, as compared to placebo, combined with~     thiopurines in the prevention of Crohn's disease post-operative recurrence.~   "
100226|NCT02255357|"~     This proposal describes a combined laboratory and clinical trial preliminary investigation to~     advance medication development for cocaine dependence. The main objective is to test whether~     intranasal Oxytocin could reduce relapse risk by reducing stress sensitivity. To measure the~     stress sensitivity, this study will evaluate a new stress challenge: a) Intranasal~     desmopressin, a vasopressin analog, will be used an endocrine stressor; its effects will be~     evaluated by serial measurements of serum Adrenocorticotropin hormone (ACTH), and self~     reports; b) if pretreatment with intranasal oxytocin dampens the ACTH and subjective response~     to intranasal desmopressin. These measures will be tested during a 7-day inpatient abstinence~     induction hospitalization. For those patients with family and work obligations, an outpatient~     abstinence induction procedure is available. The response to the desmopressin challenge will~     be compared to a cohort of matched control subjects. After abstinence induction, cocaine~     dependent patients enter a 6-week, double blind, randomized, placebo-controlled trial of 24~     IU of intranasal oxytocin vs. placebo, to monitor if this reduces the relapse risk.~   "
100227|NCT02255344|"~     Through the National Registry of patients with ACS in the IMSS (RENASCA IMSS) the~     investigators will know the real world in terms of risk factors frequency, clinical~     presentation and its complications, and in the end they can build a risk model for early~     Major Cardiovascular Events (MACE).~   "
100228|NCT02255331|"~     Patients with a total hip replacement may require early revision surgery due to an adverse~     local tissue reaction or bone resorption that occurs due to wear debris released from the~     implant. A non-invasive imaging biomarker does not exist to identify or to follow total hip~     replacement patients who are most at risk for suffering this type of premature implant~     failure. This study will evaluate magnetic resonance imaging (MRI) as a biomarker to predict~     a failing hip replacement.~   "
100229|NCT02255318|"~     The therapeutic management of patients with cancer often requires the establishment of a~     chamber implantable catheter. Infections are the main complication of these catheters. These~     infections may be responsible for a significant impairment of quality of life for patients,~     and may increase the frequency and duration of hospitalizations. The rate of mortality from~     these infections is about 17%. The objective of this study is to evaluate the efficacy of a~     1.35% taurolidine lock / 4% citrate (TauroLock®) in the primary prevention of infections~     related to chambers implantable catheter (IRCIC) in cancer patients receiving parenteral~     nutrition.~      This is a, randomized, double-blind clinical trial comparing the incidence of IRCIC in~     patients receiving Taurolidine lock or concession the usual procedure of rinsing with saline~     (placebo) (pulsed rinsing with 20 mL of serum physiological and clamping catheter positive~     pressure). The lock will be instilled after the end of the session IV treatment~     (chemotherapy, parenteral nutrition, transfusion) before closing the catheter. The primary~     endpoint will be the rate IRCIC in both groups.~   "
100267|NCT02254824|"~     The purpose of EMINENT study is to evaluate the efficacy of Xuezhikang or atorvastatin in~     hypertensive patients at low/moderate cardiovascular risk.~   "
100234|NCT02255253|"~     In this research, the investigators aim to compare the antihypertensive efficacy and safety~     of monotherapy of routine dose angiotensin receptor antagonist telmisartan (ARB) and diuretic~     Hydrochlorothiazide (HCTZ) in high sodium intake patients with mild to moderate hypertension.~     The research will be conducted in the rural area in Hebei province, where people have a high~     sodium diet in their daily life. The 1200 eligible subjects will be drawn from 12 local~     county-level hospitals. Subjects will be randomly allocated in double-blind manner into ARB~     or HCTZ group to be administered telmisartan 40mg per day or hydrochlorothiazide 25mg per day~     respectively. After two-month treatment, the investigators will evaluate and compare the~     antihypertensive efficacy and safety between the two therapies.~      The first objective of the research is to compare the antihypertensive efficacy of~     monotherapy of routine dose of angiotensin receptor antagonist telmisartan (ARB) and diuretic~     Hydrochlorothiazide (HCTZ) in high sodium intake patients with mild to moderate~     hypertension.The second objective is to compare the safety between the two therapies applied.~      Null Hypothesis-H0: There will be no efficacy differences of lowering the systolic pressure~     between treating high sodium intake patients with mild to moderate hypertension with~     telmisartan and hydrochlorothiazide.Alternative Hypothesis-H1: There will be efficacy~     differences of lowering the systolic pressure between treating high sodium intake patients~     with mild to moderate hypertension with telmisartan and hydrochlorothiazide.~      This research is a multicenter randomized double-blinded parallel controlled trial targeting~     on high sodium intake patients with mild to moderate hypertension in China. The eligible 1200~     subjects will be randomly divided into ARB and HCTZ two groups, treated with monotherapy of~     telmisartan 40mg per day or hydrochlorothiazide 25mg per day respectively. Then, the~     compliance of the patients will be followed after a week. The investigators will evaluate the~     efficacy of blood pressure control and the safety of the medicines after one month and two~     months of the beginning of therapies. Figure 1 shows the research process.~   "
100235|NCT02255240|"~     The purpose of this study is to test an intervention that uses home console video games to~     encourage increased physical activity among postmenopausal breast cancer survivors.~   "
100236|NCT02255227|"~     This is a multicenter, prospective, randomized, open study comparing two anti-pneumococcal~     vaccination strategies in patients with Chronic Inflammatory Bowel Disease (CIBD) treated by~     immunosuppressants and/or biotherapies. At present such patients are poorly protected by~     anti-pneumococcal vaccination. In addition, vaccination efficacy in this type of patient is~     much weaker than in the general population. There are two types of anti-pneumococcal~     vaccines: firstly a polysaccharide, Pneumo23® (PSV-23®) vaccine and secondly a conjugate,~     Prevenar13® vaccine. New recommendations have just been issued by the HSCP advising~     immunocompromised patients to follow a vaccination plan combining one dose of Prevenar13®~     followed by one dose of PSV-23® after an interval of two months. In the case of young~     children infected with HIV, the recommendation is to multiply doses of Prevenar13® before the~     PSV-23® injection to improve vaccine efficacy in these immunocompromised patients.~      Our study aims to identify an optimal vaccination strategy for immunocompromised CIBD~     patients by combining use of a conjugate vaccine, Prevenar13® and a polysaccharide vaccine,~     PSV-23®. We will compare the use of one or two doses (M0 +/- M2) of Prevenar13® combined with~     a later PSV-23® injection (M4) on vaccination immunogenicity measured by antibody titer~     against at least nine of the thirteen pneumococcal serotypes contained in Prevenar13®. We~     also want to evaluate the immunological impact of these different strategies in their~     capacity to stimulate a memory B anti-pneumococcal response more effectively. With this aim,~     we are studying all immunological functional aspects of the antibodies and B lymphocytes~     induced by the two vaccine strategies.~   "
100237|NCT02255214|"~     Central Neuraxial Blockade (CNB) is commonly used in anaesthetics. It has several advantages~     over a general anaesthetic however contraindications include coagulopathy. Guidelines suggest~     a CNB should not be undertaken with an International Normalised Ratio (INR) of 1.5 or~     greater. A common cause of an elevated INR is warfarin therapy and regular monitoring of its~     effects is required.~      The Hemochron Signature Elite is a portable micro coagulation system that can be used as a~     point of care (POC) anticoagulation monitoring device. Marketing is focussed on its accuracy,~     convenience and efficiency in delivering a coagulation result.~      This study will assess the accuracy of this device in calculating the International~     Normalised Ratio (INR) result. This will be compared to another INR result obtained on the~     same sample via the current gold standard testing equipment in the Royal Infirmary Edinburgh~     (RIE) laboratories.~      The study will include patients presenting for surgery who have had their warfarin therapy~     stopped within the previous 7 days. Patients on warfarin therapy requiring surgery are~     currently identified in preoperative assessment clinics, on average 12 weeks prior to their~     date of surgery.~      Anecdotally there appears to be a difference between the 'expected' and actual INR when a POC~     device is used. Concern exists that patients may be inappropriately denied the potential~     benefits of central neural blockade (CNB) if a POC device provides a falsely high result, or~     conversely the investigators may be proceeding with CNB in patients with an unacceptably high~     INR if POC provides a falsely low result. There is also the possibility of improving hospital~     efficiency using this device as it provides a result much faster than the laboratory.~   "
100238|NCT02255201|"~     The purpose of this study is to determine the effects of four different pre-workout beverages~     as compared to placebo on muscular strength and endurance, perceived energy and cognitive~     performance in healthy adult males.~   "
100239|NCT02255188|"~     The purpose of this study is to determine whether the Vascular prosthesis manufactured by~     Electrospinning is safe with respect to the development of thrombosis.~   "
100240|NCT02255175|"~     Using neuroimaging, the investigator will study the effects of estrogen on mood and brain~     function in perimenopausal women either with or without depression.~   "
100241|NCT02255162|"~     This research study is evaluating the safety and tolerability of the drug lenalidomide in~     combination with and following mismatched related donor microtransplantation in high risk AML~     patients in first remission. This study also aims to define the maximum tolerated dose (MTD)~     of lenalidomide given in this setting.~      Microtransplantation seeks to give the participant donor cells in hopes that those cells can~     attack the underlying cancer. However, since the donor cells do not replace all of the host~     cells, it can hopefully avoid many of the serious risks involved with standard transplant,~     including graft-vs.-host disease (GVHD) - a complication where the donor cells attack the~     participant's normal body. Recent studies have suggested that lenalidomide can help aid donor~     cells to attack cancer when given after a stem cell transplant. This trial is trying to see~     if lenalidomide can help encourage the attack of leukemia cells by donor cells given as part~     of microtransplantation.~      The FDA (the U.S. Food and Drug Administration) has approved lenalidomide but it has been~     approved for other uses such as in the treatment of other cancers including multiple myeloma~     and non-Hodgkin lymphoma. Although lenalidomide has been studied in patients with AML, it has~     not been approved by the FDA for standard use in AML. Lenalidomide is a compound made by the~     Celgene Corporation. It has properties which could demonstrate antitumor effects. The exact~     antitumor mechanism of action of lenalidomide is unknown.~   "
100290|NCT02254525|"~     The purpose of this study is to study the efficacy of intravenous administration of ibuprofen~     compared to placebo in patients with postoperative pain and evaluate its tolerability and~     safety profile.~   "
100242|NCT02255149|"~     This study will involve placing donor bone into the back of lower jaw then covering with a~     newly designed titanium mesh. The mesh will then stay in the mouth for 4 months before it~     will be removed. Implants will be placed in the newly formed bone.~      The goal of this study is to test how well using a newly designed titanium mesh and bone~     particles can grow bone in the back of the lower jaw. The investigators are also checking if~     the newly formed bone will stay around implants that will have been in use for 12 months.~   "
100243|NCT02255136|"~     The purpose of this study is to test whether individualized homeopathic medicines can produce~     any significant effect beyond placebo in treatment of allergic rhinitis and/or induced~     bronchial asthma~   "
100244|NCT02255123|"~     This study is a multicenter, non-randomized, retrospective study to collect long term (4~     years post-transplant) clinical outcome data on subjects previously enrolled in the CTOT-05~     study (NCT00466804) to evaluate participant and graft survival.~   "
100245|NCT02255110|"~     This is a Phase 2, single-arm, Japanese multicenter trial to evaluate the safety,~     tolerability, and efficacy of TH-302 in combination with doxorubicin in subjects with locally~     advanced unresectable or metastatic soft tissue sarcoma (STS).~   "
100246|NCT02255097|"~     This is a study of single-agent pembrolizumab (MK-3475) in participants with recurrent and/or~     metastatic head and neck squamous cell carcinoma (HNSCC) who have progressed on~     platinum-based and cetuximab therapy. The primary study hypothesis is that pembrolizumab will~     provide a clinically meaningful objective response rate (ORR).~      With protocol amendment 04 (30-Nov-2017), once study participants have achieved the study~     objective or the study has ended, participants will be discontinued from this study and~     enrolled in an extension study to continue protocol-defined assessments and treatment.~   "
100247|NCT02255084|"~     Despite the existence of an effective screening test (pap smear), cervical cancer is, every~     year in France, the cause of more than 3,000 new cases and 1,100 deaths. But, in France, 4 in~     10 women are not screened or not often enough (nearly 7 millions women). It is therefore~     necessary to develop new strategies to reach these women. The etiological factor of this~     cancer is persistent infection with High-Risk Human PapillomaVirus oncogene (HR-HPV).~     Thereby, HPV-based tests could be alternative screening tests. Vaginal self-sampling with~     HR-HPV test is simpler and less intrusive than the pap smear. It has been shown that vaginal~     self-sampling with HPV test is a powerful means to increase the participation rate in~     cervical cancer screening.~   "
100248|NCT02255071|"~     In recent years, there is an increasing trend in the number of patients with Gastroesophageal~     reflux disease (GERD). The poor response to medicine was noticed in patients with non-erosive~     reflux disease. According to the theory of traditional Chinese medicine, acupuncture Neiguan~     (P6 point) could improve the uncomfortable symptoms of the chest and upper abdomen.~     Therefore, the aim of this study is to investigate the clinical efficacy of Neiguan (P6~     point) acupressure in patients with GERD.~   "
100249|NCT02255058|"~     It was decided to develop a comprehensive disability score specifically designed for patients~     receiving prolonged mechanical ventilation (PMV); the collection of information included in~     the score should not impose any further intervention beyond what is routinely performed. So a~     new questionnaire was created (called the Multi-INdependency Dimensions (MIND) that included~     3 sections (nurse, physiotherapist and medical doctor), 11 categories and 18 items. Each~     question was adapted to have a 5 item Likert scale.~      The primary objective of the study will be to evaluate the psychometric performance of the~     MIND score in terms of validity, reliability and sensitivity to change over time. The~     secondary objective will be to assess the inclusion of biological markers on the overall~     performance of the MIND score~   "
100250|NCT02255045|"~     The investigators propose that the sustained vaginal administration would have a better~     response with respect to pain, and a better safety profile than the oral administration of a~     non-steroidal anti-inflammatory drug.~      Assess the relief of the symptoms associated to dysmenorrhea a specific survey was elaborated~     that also included a Visual Analog Scale (VAS) to make objective and measure dysmenorrhea as~     is the case with McGill's Pain Questionnaire (MPQ).~   "
100251|NCT02255032|"~     The study is designed to evaluate the safety and efficacy of triamcinolone acetonide, CLS-TA,~     in subjects with macular edema following non-infectious uveitis. A single suprachoroidal~     injection of one of two doses of CLS-TA will each be evaluated in subjects with macular edema~     following non-infectious uveitis.~   "
100252|NCT02255019|"~     The aim of this study is to find an optimal magnetic resonance imaging (MRI) method to~     examine patients with inflammatory bowel disease (IBD). Patients should furthermore avoid~     being exposed to unnecessary X-rays and invasive examination.~      It is the investigators expectation that this study will benefit to future patients, as they~     will be offered MRI as the first choice. Hereby, the patients avoid the risks and discomfort~     associated with x-ray examinations. The aim is that patients with IBD achieve better and~     earlier treatment and if this is achieved it both benefits patient and public health. An~     earlier treatment leads to fewer hospitalizations and thereby saving the community money.~      The investigators hope is that the investigators study will show that MRI is one of the best~     tool to examine patients with IBD and that this in future leads MRI to be the first choice in~     contrary to all examinations with x-ray exposer, unless there is any contraindication to MRI.~   "
100253|NCT02255006|"~     Some studies suggest that acupuncture improve flow mediated dilation (FMD) that represents~     endothelial function, but no study has investigated whether acupuncture protects against~     ischemia and reperfusion (IR)-induced endothelial dysfunction in humans.~      This is a prospective crossover study clinical trial. In the first crossover study, 20~     healthy nonsmoking volunteers (25 to 40 years old) will be randomly assigned to acupuncture~     or control. Endothelium-dependent, FMD of the brachial artery will be measured before and~     after IR (15 minutes of ischemia at the level of the proximal upper arm followed by 15~     minutes of reperfusion). Acupuncture will be performed from 10 minute after ischemia till the~     end time of reperfusion for 20 minutes. In the second single arm study, 16 volunteers are~     administered oral 5mg glibenclamide two hours before IR injury (n=8) or selective cox-2~     inhibitor celecoxib 200mg twice a day for 5 days to know what mechanism is responsible for~     acupuncture effect on IR injury. FMD measurements and acupuncture intervention during IR~     injury are same as above mentioned.~   "
100330|NCT02253992|"~     The purpose of this study is to determine which doses of Urelumab and Nivolumab are safe and~     tolerable when they are given together.~   "
100254|NCT02254993|"~     Part A: Open-label, multiple arm, safety, microbiology and pharmacokinetic (PK) study in~     healthy adult male and female subjects 18-75 years of age. All subjects will be assessed for~     safety and microbiology parameters. A subset of subjects will be assessed for pharmacokinetic~     parameters. No longer enrolling study subjects in Part A.~      Part B: Open-label, multiple arm, safety and microbiology study in healthy adult male and~     female subjects 18-75 years of age. All subjects will be assessed for safety,~     pharmacokinetic, and microbiology parameters.~   "
100255|NCT02254980|"~     In vitro, Vitamin-E diffused, highly cross-linked polyethylene (PE) have been shown to have~     superior wear resistance and improved mechanical properties as compared to that of standard~     highly cross-linked PE. There are as of yet no published studies with vitamin-E diffused PE~     although several trials are ongoing. All of these trials use uncemented acetabular cups~     intended for biological fixation. In many countries the standard fixation method for the~     acetabular component is bone-cement. The Vitamin-E used in implants is alfa-tocopherol, a~     lipid-soluble antioxidant with oily consistency; theoretically affecting cemented fixation~     when used in acetabular components. The aim of the study is to compare migration, linear wear~     and clinical results between two types of cemented acetabular cups.~   "
100256|NCT02254967|"~     The main objective of the study is to evaluate whether the extended duration fidaxomicin~     therapy is superior to the standard vancomycin therapy in sustained clinical cure of CDI at~     30 days after end of treatment (Day 40 or Day 55).~   "
100257|NCT02254954|"~     This is a prospective, single-center, open-label, 3+3 dose escalation Phase 1 safety study.~     Adults with newly diagnosed GBM or gliosarcoma will receive macitentan in addition to the~     standard of care treatment for GBM. The study consists of a screening period, a treatment~     period, and a 30-day safety follow up period. The treatment period includes 6 weeks of~     concurrent therapy (macitentan+RT+TMZ), 4 weeks of monotherapy (macitentan) and 12 cycles of~     maintenance therapy (macitentan+TMZ). The study will end when the last treated subject has~     completed study treatment and the 30-day safety follow-up period.~      The planned duration of the study is approximately 34-38 months depending on the number of~     dose levels and cohorts of subjects enrolled. Subject participation in the study will be for~     approximately 16 months.~   "
100258|NCT02254941|"~     The purpose of this study is to evaluate, in terms of overall survival, the benefit of~     monoclonal antibodies in the start time of the diagnosis of advanced disease or administer a~     deferred basis after progression to treatment with chemotherapy alone.~   "
100259|NCT02254928|"~     A randomised, crossover, multicentre, national, clinical trial comparing the efficacy of~     corifollitropin alfa versus daily recombinant FSH and HMG in the controlled ovarian~     stimulation of women with a poor ovarian response undergoing IVF treatments. The main~     objective of this study is comparing the number of oocytes obtained after the follicle~     puncture when using each of these two stimulation protocols. Only poor responders according~     to the Bologna criteria will be recruited for this trial. All participants will undergo two~     stimulation cycles to obtain and accumulate oocytes by vitrification. One of the cycles will~     be done with the corifollitropin alfa protocol and the other with daily rFSH and HMG, the~     order of application of these protocols will be randomised (crossover clinical trial) in each~     patient.~   "
100260|NCT02254915|"~     A multi-institutional, prospective, randomised, open-label, superiority, comparative,~     active-controlled, phase 3 study. The study will compare Synergo RF-induced~     hyperthermia-chemotherapy (SHTC) plus mitomycin C (MMC) to standard treatment of bacillus~     Calmette-Guérin (BCG) therapy as first-line adjuvant treatment for intermediate and high-risk~     NMIBC, and will evaluate recurrence and progression rate over two years of follow-up.~   "
100261|NCT02254902|"~     There is a significant need for culturally adapted and effective health education programs to~     address rising rates of obesity and chronic disease concerns for refugee communities.~     Physical activity has been identified as an important prevention tool to prevent numerous~     chronic health conditions. This research tests the feasibility and acceptability of a~     culturally adapted physical activity intervention for sedentary adult Somali women. Study~     participants will be randomized to a 3-month physical activity program or a wait-list control~     group. The primary outcome is increases in physical activity between baseline and the end of~     the program as measured by pedometer.~   "
100262|NCT02254889|"~     Endoscopic submucosal dissection (ESD) is widely used for local treatment of gastric~     neoplasms. Although ESD-related complications such as bleeding and perforation have been~     reported, data is currently lacking on the development of pain, which is one of the most~     common adverse events after ESD. Therefore, in the present study, we investigated the~     incidence and clinicopathologic risk factors of pain after ESD.~   "
100263|NCT02254876|"~     Painful Shoulder Syndrome is a frequent complication after stroke occurring in between 5% and~     84% of patients, often having a strong impact on their well-being and resulting in delays~     achieving rehabilitative objectives.~      The aim of the study is to demonstrate the effectiveness of Neuromuscular Taping in a~     population of post-stroke hemiplegic patients suffering from painful shoulder syndrome with~     respect to pain, spasticity and range of motion.~   "
100264|NCT02254863|"~     The primary objective of the study is to determine the safety and feasibility of intrathecal~     administration of DUOC-01 as an adjunctive therapy in patients with inborn errors of~     metabolism who have evidence of early demyelinating disease in the central nervous system~     (CNS) who are undergoing standard treatment with unrelated umbilical cord blood~     transplantation (UCBT). The secondary objective of the study is to describe the efficacy of~     UCBT with intrathecal administration of DUOC-01 in these patients.~   "
100265|NCT02254850|"~     The purpose of the study was to characterize the action of mesoglycan on vascular endothelium~     through the non-invasive assessment of vascular reactivity humeral artery by comparing~     effects of mesoglycan on Flow Mediated Dilatation (FMD) of the humeral artery between a group~     of patients with metabolic syndrome assuming placebo and a group of patient with metabolic~     syndrome assuming mesoglycan; firstly after administration of the drug/placebo~     intramuscularly, and then, in a study of medium-term after oral intake of drug/placebo. The~     selection of patients with metabolic syndrome is related to the fact that this syndrome is~     associated with alterations in endothelial function and a high incidence of cardiovascular~     events. So it is a condition that offers the opportunity to explore the hypothesis that the~     mesoglycan may have a favorable effect on early vascular alterations that precede clinical~     events.~   "
100266|NCT02254837|"~     Japanese post market clinical study of the Zilver PTX device.~   "
100268|NCT02254811|"~     Delivery of FMT by upper route, including gastroscopy, nasogastric/ nasojejunal tube, and~     lower route, including retention enema, sigmoidoscopy, or colonoscopy have all been utilized~     successfully. Endoscopic delivery requires significant health care utilization and associated~     cost. Therefore, it is extremely desirable if FMT can be infused by a non invasive modality,~     which would significantly reduce patient discomfort, procedure related risks and health care~     costs, while offering similar efficacy to colonoscopic delivery in the range of 90%.~   "
100269|NCT02254798|"~     Validation of already described biomarkers on acute GVHD prediction and severity Fecal~     calprotectin and alpha 1 anti-trypsin, plasmatic RER3a, IL-8, Elafin, TNFaR1, IL-2R alpha,~     HGF~   "
100270|NCT02254785|"~     The purpose of this study is to assess and compare the clinical benefit rate in patients with~     metastatic castrate-resistant prostate cancer and poor prognostic factors treated with~     cabazitaxel or novel hormonal agents (abiraterone or enzalutamide) as initial therapy, to~     determine which treatment is most active in this population. Clinical benefit rate is defined~     as PSA or measurable radiological response of any duration or stable disease for > or equal~     to 12 weeks, in the absence of other indicators of progression.~      There is option to cross-over onto the other arm if the patient progresses.~   "
100271|NCT02254772|"~     This phase 1-2 trial studies the side effects and best dose of ipilimumab in combination with~     toll-like receptor 9 (TLR9) agonist SD-101 and radiation therapy in treating patients with~     recurrent low-grade B-cell lymphoma.~   "
100272|NCT02254759|"~     This is a non-randomized, open-label, five treatment, fixed sequence cross-over study to~     investigate the effect of RO5186582 treatment on CYP3A activity using midazolam as a probe~     CYP3A substrate, and also to assess the pharmacodynamic measures of brain electrical activity~     and sedation to explore the pharmacodynamic interaction between the gama-amino butyric acid~     (GABA)A negative allosteric modulator RO5186582 and the prototypical GABAA positive~     allosteric modulator midazolam. The anticipated study duration is up to nine weeks.~   "
100273|NCT02254746|"~     The aim of this study is to test the safety and efficacy of Stereotactic Body Radiation~     Therapy (SBRT) in localized prostate carcinoma in patients for whom the standard treatment is~     the irradiation of the entire prostate gland with or without seminal vesicles accompanied or~     not by hormonal therapy. In light of the accumulating clinical evidence favoring the use of~     hypo fractionation, SBRT regimen might constitute a much more convenient non-invasive and~     highly efficient outpatient therapy.~   "
100274|NCT02254733|"~     This project is an effectiveness trial comparing two psychosocial treatments for~     schizophrenia: Assertive Community Treatment (ACT) + Cognitive Behavioral Social Skills~     Training (CBSST) v. ACT, alone.~   "
100275|NCT02254720|"~     Evaluation of safety, tolerability and pharmacokinetics of single rising intravenous doses of~     BEA 2180 BR; additional exploration of metabolism following inhalation~   "
100276|NCT02254707|"~     To assess the antiviral effect, safety and pharmacokinetics of rising doses of 10 mg, 20 mg,~     40 mg, 60 mg, 80 mg, 100 mg, 150 mg, 200 mg, 300 mg, 450 mg, 650 mg, 900 mg oral BILB 1941 ZW~     administered Q8H in a polyethyleneglycol 400 (PEG 400): distilled water: Tromethamine (TRIS)~     drinking solution for five days to patients with chronic HCV genotype 1 infection~   "
100277|NCT02254694|"~     The purpose of this study is to investigate the influence of high heeled shoes on the~     sagittal balance of the spine and the whole body.~      The investigators hypothesize that wearing high heeled shoes leads to a hyperlordosis of the~     cervical spine, a decrease of thoracic kyphosis, hyperlordosis of the lumbar spine and a~     posterior tilt of the pelvis resulting in a posterior shift of the body's center of gravity.~     This would be an explanation for the increased prevalence of back pain in individuals~     frequently wearing high heels.~      In order to assess these changes, differences in the two following outcome parameters will be~     measured on a standing lateral EOS-radiograph of the whole body - barefoot and with high~     heeled shoes: spino-sacral angle (primary) and meatus plumb line (secondary) .~   "
100278|NCT02254681|"~     The overall goal of this study is to determine the safety and efficacy of combination~     treatment of low-dose fractionated radiation therapy with gemcitabine-cisplatin chemotherapy~     for locally advanced mass forming intra-hepatic cholangiocarcinoma.~   "
100279|NCT02254668|"~     Randomized prospective multi-center imaging study which investigates the impact of different~     immunosuppressive protocols (Everolimus (Certican®) or Mycophenolate mofetil (CellCept®)) on~     cardiac allograft vasculopathy (CAV) in heart transplanted patients. Maximal intima-thickness~     will be visualized by optical coherence tomography (OCT) to assess the progression of CAV.~   "
100280|NCT02254655|"~     The purpose of this study is to access the effect (week 12/week 24) of puerarin injection on~     carotid intima-media thickness (CIMT) in rheumatoid arthritis (RA) patients despite routine~     anti-rheumatic treatment.~   "
100281|NCT02254642|"~     Open surgery for aneurysmal aortic disease can lead to cardiac, renal, pulmonary or muscular~     complications, essentially due to the aortic clamping. Ischemic preconditioning can be useful~     in order to decrease these complications. The investigators would like to use an ischemic~     preconditioning protocol during open surgery of aortic aneurysm in order to decrease these~     complications.~   "
100282|NCT02254629|"~     the laxative-probiotic sequential treatment might reduce the symptoms of IBS and alter the~     fecal microbiota of the patients in a more robust manner .~   "
100283|NCT02254616|"~     Contemporary behavior interventions focused on upper limb training such as robotic-assisted~     training and constraint-induced movement therapy have been proven to promote motor recovery.~     However, the improvement is often of limited in practical significance. Mirror therapy (MT)~     and transcranial direct current stimulation (tDCS) on brain based on similar principle of~     utilizing brain plasticity have shown benefits in promoting motor function recovery and are~     particularly easy to apply in different settings. tDCS activates a bulk of neural circuits in~     a non-specific way, coupling tDCS with MT could steer plastic process toward a functional~     direction. However, current evidence is insufficient to support the efficacy of tDCS as an~     adjuvant to upper limb training, and long-term effect has yet to be explored.~      Cortical stimulation clearly has its role in stroke rehabilitation. However, current evidence~     is insufficient to support the efficacy of tDCS as an adjuvant to MT, and long-term effect~     has yet to be explored. Therefore, this randomized clinical trial will aim to examine (1) the~     beneficial effects of hybrid therapy (i.e., MT with tDCS) on health-related outcomes in~     patients with chronic stroke; (2) the long-term benefits of the hybrid therapy on activity~     participation at 6-month follow-up; (3) the underlying mechanisms of the hybrid therapy on~     motor control and brain organization; (4) the correlations between brain excitability~     patterns and movement kinematics/health-related outcomes. Accordingly, we will compare the~     hybrid therapy vs MT with sham tDCS vs MT vs conventional intervention (CI) on motor~     performance, daily function, and activity participation. We will also examine underlying~     mechanisms by kinematic measures for motor control and fMRI analyses for brain~     reorganization. The MT with sham tDCS group is included to achieve a double-blinded design~     (patient and evaluator blinded) with the MT with real tDCS group. The MT only group is~     included to examine if there exist a placebo effect of the presence of tDCS setting in the MT~     with sham tDCS. The CI group is included to provide a baseline treatment to see if the other~     three therapies induce larger improvements compared to currently standard therapy. We~     hypothesize that (1) the hybrid therapy will induce greater improvements on some~     health-related outcomes compared to other therapies; (2) such benefits will retain at 6-month~     follow-up; (3) better motor control and brain reorganization will be found in the hybrid~     therapy than the other therapies; (4) correlations will be found between brain activity and~     movement kinematics/health-related outcomes. This study will be the first to investigate~     effects of the hybrid therapy, MT with tDCS, in chronic stroke. This study is unique in~     examining changes at different levels including motor performance, daily function, and~     activity participation, as well as brain and motor organization. To address the inconsistent~     benefits in daily function outcomes in previous research in MT and tDCS in stroke~     rehabilitation, we will modify the existing treatment protocols and include a 30-minute~     functional training into each treatment session in all groups. The result of this project~     might unveil a potentially better hybrid intervention for chronic stroke population to choose~     from, compared to a stand alone therapy such as MT and CI. And the result will also provide~     information on changes in motor control and brain organization which help understand the~     underlying mechanism. The follow-up examination will provide information on long term effect~     at the level of activity participation, which is crucial considering that chronic stroke~     patients are most likely living in community. In addition, we may provide critical~     information on the association between brain activity and movement patters/functional~     outcomes in terms of analyzing the correlation of fMRI data with hand kinematics/~     health-related outcomes.~   "
100284|NCT02254603|"~     The aim of this study is to examine the effects of combination of acupuncture and ayuveda~     yoga exercise on weight loss for the overweight.~   "
100285|NCT02254590|"~     To evaluate a new endoscopic technique for lumbar spinal canal decompression.~   "
100286|NCT02254577|"~     To determine whether the of vaginal progesterone replacement for frozen embryo transfer~     results in equivalent live birth rates to intramuscular injection progesterone replacement.~   "
100287|NCT02254564|"~     The main objective of this study is to identify unique DNA sequences within the genome of~     human scabies that can be utilized to identify the parasite through PCR.~   "
100288|NCT02254551|"~     The purpose of the study is to determine whether the combination of LDE225 (sonidegib) plus~     bortezomib is safe and effective in the treatment of relapsed or relapsed/refractory multiple~     myeloma.~   "
100289|NCT02254538|"~     Assessment of safety, tolerability and preliminary pharmacokinetics in healthy male~     volunteers after oral administration of BILR 355 BS~   "
100292|NCT02254486|"~     This study evaluates the efficacy, safety and tolerability of NER1006 versus Trisulfate~     Solution (TS) in adult patients requiring bowel cleansing prior to any procedure that~     requires a clean bowel, using a 2-Day evening/morning Split-Dosing regimen. Approximately 540~     patients will be randomised with the aim of achieving a minimum of 245 patients in each of~     the 2 groups.~   "
100293|NCT02254473|"~     This study is looking at the efficacy of a sloped insole in patients with knee~     osteoarthritis. Regularly wearing a sloped insole over the course of one year will result in~     a wider joint space by x-ray in 60% of the subjects, a significant decrease in knee pain,~     decreased use of over the counter analgesics, and a clinically important improvement in the~     Womac pain and stiffness scale.~   "
100294|NCT02254460|"~     The present study supplements iron as part of multiple micro-nutrient supplementation to~     demonstrate that intake of a micronutrient fortified powder in milk helps increase the uptake~     of key micronutrients like iron due to unique nature of the given matrix, as compared to~     intake of iron alone in milk.~   "
100295|NCT02254447|"~     This study will investigate the relative bioavailability of two candidate tablet formulations~     of 16 milligram (mg) Candesartan cilexetil (GW615775) compared with the reference product~     ATACAND™ containing 16 mg Candesartan cilexetil in healthy human subjects. This is an~     open-label, randomized, single dose, three-way crossover, six sequence study enrolling 18~     healthy human subjects to ensure at least 14 subjects complete the study as planned. Each~     subject enrolled will participate in all three treatment periods and will be assigned to one~     of the six treatment sequences, in accordance with the randomization schedule. The treatment~     periods will be separated by a washout period of at least 7 days and no more than 14 days~     between dosing occasions. A follow up visit will be conducted 14-21 days post last dosing.~     ATACAND is a registered trademark of the AstraZeneca group of companies.~   "
100296|NCT02254434|"~     This study evaluates pharmacokinetics of eltrombopag 50 mg after the oral administration in~     Mexican healthy volunteers under fasting conditions. The study will be an open label, single~     dose study with 26 subjects planned to be enrolled. Healthy subjects (male and female) aged~     between 18 - 50 years of age (inclusive) and a Body Mass Index within the range of 18-27.0~     kg/meter (m)^2 (inclusive) were enrolled according to Quetelet. REVOLADE is a registered~     trademark of the GSK group of companies.~   "
100297|NCT02254421|"~     The primary objective of this study is to evaluate the effect of presatovir on respiratory~     syncytial virus (RSV) viral load in autologous or allogeneic hematopoietic cell transplant~     (HCT) recipients with an acute RSV lower respiratory tract infection (LRTI).~   "
100298|NCT02254408|"~     This study will evaluate the effect of presatovir on respiratory syncytial virus (RSV) viral~     load in autologous or allogeneic hematopoietic cell transplant (HCT) recipients with an acute~     RSV upper respiratory tract infection (URTI), the effect of presatovir on development of~     lower respiratory tract complication, being free of any supplemental oxygen progression to~     respiratory failure, and pharmacokinetics (PK), safety, and tolerability of presatovir.~   "
100299|NCT02254395|"~     The purpose of this clinical study is to verify the long term effecacy and safety of a~     bilateral deep brain stimulation (DBS) produced by Beijing PINS Medical Co., Ltd. as a~     treatment option for patients with obesity.~   "
100300|NCT02254382|"~     This is a multicenter, prospective, randomized clinical trial (pilot study). 20 participants~     with diastolic heart failure will be assigned to ventilation therapy (AutoSet CS ™ ASV~     device; therapy group). The trial will run for 6 months, after which change in~     echocardiographic parameters of diastolic left ventricular function, sleep and quality of~     life parameters will be evaluated.~   "
100301|NCT02254369|"~     The primary objective of the study is to assess the safety and tolerability of single oral~     doses of GC021109 when administered to healthy adult subjects.~   "
100302|NCT02254356|"~     Japanese post market clinical study of the Zilver Flex device.~   "
100303|NCT02254343|"~     The purpose of this study is to compare the training effects of robot-assisted therapy focus~     on proximal part, distal part, or total segment of upper extremity, respectively.~   "
100304|NCT02254330|"~     The objectives of this study is to assess the characteristics and frequency of adenovirus~     conjunctivitis in a population of male and female patients from one year of age who present~     signs and symptoms of acute conjunctivitis.~   "
100305|NCT02254317|"~     The objective is to identify the lowest effective dose of Grape Seed Extract (GSE) on glucose~     control in people with impaired glucose tolerance (IGT).~   "
100306|NCT02254304|"~     This is a Phase 4, interventional, multicenter study of subcutaneous Rebif® (interferon~     beta-1a) using RebiSmart™ device to assess effectiveness and adherence of treatment in~     subjects with clinically isolated syndrome (CIS) or relapsing multiple sclerosis (RMS).~   "
100307|NCT02254291|"~     This trial is conducted in Japan. The purpose is to compare the safety of once-weekly dosing~     of semaglutide (0.5 and 1.0 mg) versus sitagliptin (100 mg) once daily, both as monotherapy~     during 30 weeks of treatment in Japanese subjects with type 2 diabetes.~   "
100308|NCT02254278|"~     This randomized phase II trial studies the side effects and how well modestly reduced-dose~     intensity-modulated radiation therapy (IMRT) with or without cisplatin works in treating~     patients with oropharyngeal cancer that has spread to other places in the body (advanced).~     Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy,~     such as cisplatin, work in different ways to stop the growth of tumor cells, either by~     killing the cells, by stopping them from dividing, or by stopping them from spreading. It is~     not yet known whether IMRT is more effective with or without cisplatin in treating patients~     with oropharyngeal cancer.~   "
100309|NCT02254265|"~     This is a Phase 2/3 study to evaluate the safety and efficacy of 2 different dose~     concentrations of OTX-101 dosed twice a day in both eyes for 84 days compared to placebo~     (vehicle) in patients with keratoconjunctivitis sicca (dry eye disease).~   "
100331|NCT02253979|"~     Double lumen tube (DLT) is an enotracheal tube that facilitates one lung ventilation. The DLT~     exact position in the airways is verified by fiber-optic bronchoscopy (FOB) after intubation.~     The VivaSight TM DL is a single use left DLT with a camera embedded in the tube's right side~     port. This study was designed to compare the VivaSightTM DL to the standard DLT.~   "
100978|NCT02245568|"~     The purpose of this study is to provide subjects who have completed participation in a Phase~     2 or Phase 3 trial with TRx0237 continued access to therapy and to evaluate the long-term~     safety of TRx0237.~   "
100310|NCT02254252|"~     Slow coronary flow is an angiographically diagnosed phenomenon defined as delayed~     opacification of epicardial arteries in the absence of significant arterial narrowing and~     blockade. Endothelial dysfunction at the level of microarteries have been proposed as the~     main pathological mechanism in this regard. Available evidence suggest that standard~     anti-angina medications (e.g. nitroglycerin) that solely target large coronary trunks might~     not provide adequate symptomatic relief in patients with slow coronary flow phenomenon. It is~     hypothesized that anti-angina medications which exert vasodilatory effects in large coronary~     arteries as well as small dividing branches might be superior to nitroglycerin in~     amelioration of angina symptoms. The present randomized clinical trial was thus designed and~     conducted to compare the short-term efficacy of nicorandil (a dual-acting anti-angina~     medication with effects on both large and small coronary vessels) with nitroglycerin in a~     group of patients with slow coronary flow presented with frequent angina episodes.~   "
100311|NCT02254239|"~     This phase I trial studies the side effects and the best dose of everolimus when given~     together with brentuximab vedotin in treating patients with Hodgkin lymphoma that has come~     back (relapsed) or is not responding to treatment (refractory). Everolimus may stop the~     growth of cancer cells by blocking some of the enzymes needed for cell growth. Brentuximab~     vedotin may interfere with the ability of cancer cells to grow and spread by binding to a~     protein on the surface of cancer cells and then releasing a cancer-killing substance to them.~     Giving everolimus together with brentuximab vedotin may be a better treatment for Hodgkin~     lymphoma.~   "
100312|NCT02254226|"~     1. To compare the systemic drug exposure of 100 μg Serevent ® Diskus ® with that of 50 μg~          Serevent ® MDI with sufficient precision so that in combination with a second trial it~          can be demonstrated that the systemic drug exposure of a new formulation of salmeterol~          xinafoate is not superior to that of Serevent ® MDI~        2. To test a system of ordered null hypotheses regarding the exposure of two dose levels of~          Serevent ® Diskus ® and Serevent ® MDI~        3. To get data about the systemic drug exposure of 25 μg Serevent ® MDI and of 50 μg~          Serevent ® Diskus ®~   "
100313|NCT02254213|"~     The main objective is to evaluate the stability of EEG features on an individual level.~   "
100314|NCT02254200|"~     Obesity is commonly associated with insulin resistance and hyperinsulinemia, which seem to be~     linked with an impaired ability to oxidize lipids, particularly in class III obese~     individuals [Body Mass Index (BMI): > 40 kg*m-2]. Exercise training is an effective strategy~     to improve insulin sensitivity and to reduce the risk of type 2 diabetes.~      This study aimed to compare the effects of two different 2-wk-long training modalities~     [continuous at the intensity eliciting the maximal fat oxidation (Fatmax) versus adapted high~     intensity interval training (HIIT)] on aerobic and metabolic fitness of class II and III~     obese men. It was hypothesized that, because of the nature of HIIT in the stimulation of~     rapid changes, aerobic fitness, fat oxidation rates during exercise and insulin sensitivity~     would be improved to a greater extent when adapted HIIT compared to Fatmax training.~   "
100315|NCT02254187|"~     The objective of this study is to investigate if the systemic drug exposure of at least 25 μg~     and perhaps 50 μg salmeterol presented as inhalation powder in PE capsules and administered~     via HandiHaler® 2 does not exceed that of 50 μg Serevent® Diskus® and to investigate safety~     and tolerability of salmeterol presented as inhalation powder in PE capsules and administered~     via HandiHaler® 2~   "
100316|NCT02254174|"~     Assessment of the relative bioavailability of a fixed dose combination of tiotropium and~     salmeterol compared to a free dose combination of the marketed products of tiotropium and~     salmeterol (Spiriva® and Serevent® Diskus®).~      Assessment of the relative bioavailability of a fixed dose combination of tiotropium and~     salmeterol compared to tiotropium and salmeterol administered as individual mono substances~     from the marketed products.~      Assessment of safety and tolerability of the fixed combination of tiotropium and salmeterol~     in a PE (Polyethylene) capsule administered via the HandiHaler® 2~   "
100317|NCT02254161|"~     The primary objective of the current study is to investigate the safety and tolerability of~     BI 1181181 in healthy young male and elderly male and female volunteers following oral~     administration of repeated rising doses of BI 1181181, given once daily over 10 days.~     Secondary objectives are the exploration of the pharmacokinetics (PK) and pharmacodynamics~     (PD) of BI 1181181.~   "
100318|NCT02254148|"~     To assess the influence of BI 187004 on kinetics of cytochrome P450 (CYP) and P glycoprotein~     (P-gp) probe drugs as a means of predicting drug-drug interactions.~   "
100319|NCT02254135|"~     Study to investigate safety, tolerability, and pharmacokinetics of single rising peroral~     doses of BEA 2180 BR~   "
100320|NCT02254122|"~     Study to investigate safety and tolerability, pharmacodynamics (PD) and pharmacokinetics (PK)~     of BEA 2180 BR~   "
100321|NCT02254109|"~     Study to evaluate safety, tolerability, and pharmacokinetics of BEA 2180 BR in Japanese~     healthy volunteers~   "
100322|NCT02254096|"~     The objectives are:~        1. To assess safety, pharmacokinetics, and pharmacodynamics of BIRT 1696 BS in rising~          single doses.~        2. To assess safety, pharmacokinetics, and pharmacodynamics of single dose of 100 mg BIRT~          1696 BS after grapefruit juice.~        3. To asses safety and pharmacokinetics of single dose of 400 mg BIRT 1696 BS after a 67 g~          fat and high caloric breakfast.~   "
100323|NCT02254083|"~     Study to assess the tolerability of an intravenous infusion of 0.5 and 1.0 mg (actual 0.8 mg)~     BIBT 986 BS per hour over 32 hours as well as pharmacokinetics and the effect on blood~     coagulation parameters~   "
100324|NCT02254070|"~     To assess the influence of different degrees of renal impairment on safety, tolerability,~     pharmacodynamics and pharmacokinetics of 1.0 mg of BIBT 986 BS given as a single dose~     infusion over 30 minutes in comparison to a normal renal function~   "
100325|NCT02254057|"~     Study to assess the tolerability of BIBT 986 BS after intravenous infusions of 0.1, 0.3, 1.0,~     2.5, 5.0, and 10 mg, to assess the pharmacokinetics of BIBT 986 BS after intravenous infusion~     and to assess the effect of BIBT 986 BS on blood coagulation parameters~   "
100326|NCT02254044|"~     maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of bivatuzumab mertansine~   "
100327|NCT02254031|"~     maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of bivatuzumab mertansine~   "
100328|NCT02254018|"~     maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of bivatuzumab mertansine~   "
100332|NCT02253966|"~     Despite improvements in analgesic treatment following total knee arthroplasty (TKA) for~     osteoarthrosis, a substantial part of patients still have severe acute pain after surgery. It~     has been suggested that preoperative degree of intraarticular inflammation is associated to~     postoperative degree of pain and level of function. Furthermore it is known, that patients~     with preoperative inflammation have hyperalgesia and severe movement related pain.~      The aim of this study is to investigate the effect of a preoperative intraarticular injection~     of Methylprednisoloneacetate in reducing acute postoperative pain after total knee~     arthroplasty in patients with signs of severe pre-operative inflammation and pain.~   "
100333|NCT02253953|"~     Assessment of the effect of two times oral 100 mg ritonavir capsules on pharmacokinetics of a~     single dose of BILR 355 BS dissolved in PEG 400~   "
100334|NCT02253940|"~     Study to determine the single dose, relative BA of new SDS-containing formulations of BILR~     355 (150 mg and 200 mg capsules and 150 mg tablet), compared to the current SDS tablet~     formulation (50 mg tablet)~   "
100335|NCT02253927|"~     The primary objective was to explore the relative bioavailability of increasing doses of BILR~     355 BS, as a sodium dodecyl sulfate-containing solid formulation (SDS), in combination with~     ritonavir 100 mg and to explore the dose-concentration proportionality of increasing doses.~      A secondary objective was to explore the effect of food on the pharmacokinetics of BILR 355~     (SDS)~   "
100336|NCT02253914|"~     Study to determine the safety, tolerability and pharmacokinetics of BILR 355 BS plus low dose~     ritonavir in healthy male volunteers.~   "
100337|NCT02253901|"~     Study to determine the pharmacokinetic effect of BILR 355 + ritonavir® on TRUVADA and TRUVADA~     on BILR 355~   "
100338|NCT02253888|"~     The objective of this trial was to establish the bioequivalence of Tipranavir (TPV) 250 mg~     self emulsifying drug delivery system (SEDDS) capsules that had been stored at a controlled~     temperature of 30°C and controlled relative humidity (RH) of 70% in comparison with TPV 250~     mg SEDDS capsules stored at controlled refrigerated conditions between 2°C and 8°C~   "
100339|NCT02253875|"~     Study to determine the effects of multiple-dose omeprazole on the single-dose~     pharmacokinetics of tipranavir and ritonavir~   "
100340|NCT02253862|"~     Study to assess the effects of single-dose and steady-state tipranavir/ritonavir 500 mg/200~     mg on the single-dose pharmacokinetics of tadalafil 10 mg~   "
100341|NCT02253849|"~     Study to assess the steady-state pharmacokinetics of carbamazepine (CBZ) at 200 mg or 100 mg~     twice daily, depending on tolerability, and administered alone and in combination with~     tipranavir/ritonavir (TPV/r) after a single dose (500/200 mg) and at steady-state (500/200 mg~     twice-daily)~   "
100342|NCT02253836|"~     Study to investigate the effects of steady-state TPV/r (500 mg/100 mg BID) on the single-dose~     and steady-state pharmacokinetics of Atazanavir (300 mg QD) co-administered with Ritonavir~     (100 mg). To investigate the effects of single-dose and steady-state Atazanavir (300 mg) on~     the steady-state pharmacokinetics of Tipranavir and Ritonavir.~   "
100343|NCT02253823|"~     The objective of this study was to characterize the effects of two dose combinations of~     tipranavir/ritonavir (TPV 500 mg/RTV 100 mg and TPV 750 mg/RTV 200 mg), administered daily~     and BID, on the pharmacokinetics of efavirenz (EFV), 600 mg daily~   "
100344|NCT02253810|"~     The goal of this randomized controlled, double-blinded trial is to assess the efficacy of~     intravenous tranexamic acid, a drug, in reducing blood loss and transfusion in patients~     undergoing periacetabular osteotomy, an elective reorientation procedure for the hip joint.~     The investigators hypothesize that tranexamic acid will be more effective than placebo~     (normal saline solution) in reducing blood loss and transfusion after periacetabular~     osteotomy.~   "
100345|NCT02253797|"~     Study to evaluate the pharmacokinetics of Tipranavir and its metabolites including excretion~     and mass balance of parent compound and radioactivity at steady-state; to isolate, identify~     and quantify major metabolites of tipranavir in plasma, urine and feces~   "
100346|NCT02253784|"~     The addition of dexamethasone (DxaM) to local anesthetic may significantly prolong the~     duration of a block in total knee arthroplasty. The aim of this study is to determine whether~     this is a systemic or local effect.~   "
100347|NCT02253771|"~     The purpose of this study is to determine whether shockwave therapy is more effective in the~     treatment of unspecific acute low back pain than sham therapy.~      60 patients with acute low back pain will be recruited to a single-blinded, randomized,~     placebo-controlled trial. They are randomized to receive either shockwave therapy or sham~     treatment by a identically looking device for 4 weeks, twice a week. Additionally patients~     receive physiotherapy twice a week and are allowed to take an anti-inflammatory drug, if~     necessary for even 4 weeks. The primary outcome variable will be measured at day 0, every~     week during treatment (day 7; 14; 21 and 28) and up to 4 weeks after the last treatment. The~     clinical outcome will be primarily measured by pain intensity using a visual analogue scale.~     Secondary outcome measures are Oswestry Disability Index, Beck`s Pain Depression Scale,~     Roland Morris Disability Questionnaire and the EQ-5D. Data will be analysed for the~     difference in change of scores between groups using one-way t-test.~   "
100355|NCT02253667|"~     The prevalence of severe dyspnoea among terminally ill patients has been reported as 70% and~     90% for lung cancer and chronic obstructive pulmonary disease (COPD) patients, respectively.~      Current management to dyspnoea includes opioids, psychotropic drugs, inhaled frusemide,~     Heliox 28 and oxygen.~      Conventional oxygen supplementation is often used in these patients, but it may be~     inadequate, especially if they require high flows (from 30L/min to 120L/min in acute~     respiratory failure).~      High-flow oxygen nasal cannula (HFONC) is a new technological device in high-flow oxygen~     system that consists of an air-oxygen blender (allowing from 21% to 100% FiO2) which~     generates the gas flow rate up to 55 L/min and a heated humidification system. This~     technology may have an important role in reducing respiratory distress in do-not-intubate~     patients.~      Some HFONC's beneficial effects are the washout of the nasopharyngeal dead space reducing~     rebreathing of CO2 and improvement oxygenation through greater alveolar oxygen concentration;~     a better matching between patient's inspiratory demand and oxygen flow; generation of a~     certain level of positive pressure (PEEP) contributing to the pulmonary distending pressure~     and recruitment; improvement of lung and airway mucociliary clearance due to the heated and~     humidified oxygen; and patient's comfort because of the nasal interface allowing feeding and~     speech.~      The investigators hypothesize that patients supported with HFONC need less opioids to~     decrease dyspnoea.~   "
100348|NCT02253758|"~     Emergence from sedation involves an increase in both the level of consciousness and arousal.~     Some insight to the neural core of consciousness was gained in the recent past. Our research~     objective is to characterize for the first time the spatiotemporal mobilization of the~     ascending reticular activating system during emergence from sedation; stated otherwise - to~     capture the neural core of arousal.~      To achieve this objective we plan to utilize the advanced imaging modality of EEG-fMRI. In~     short, volunteers will be placed in the MRI. Following baseline recordings they will be~     sedated with a continuous drip of propofol, titrated to deep sedation. Once in that sedation~     level, propofol administration will cease until emerging to an awake-calm/light sedation.~      Continuous EEG recordings and fMRI scans will be taken, both task specific (auditory oddball)~     and resting-fMRI. Analyses will focus (but will not be restricted to) on constituents of the~     ascending reticular activating system.~      The expected advances of this proposal are:~        1. Emergence from sedation (and anesthesia) is one of the critical stages and least~          elucidated area in the practice of anesthesia. Delayed awakening of varying degree is~          not uncommon after anesthesia and may have a number of different causes, individual or~          combined, which may be both drug or non-drug related, thus causing a diagnostic dilemma.~          Eventually - better insight into this subject will lead to better clinical practice and~          better understanding why patients emerge in such a diverse and sometimes unexpected~          manner.~        2. Knowledge of the internal structure underlying arousal from anesthesia will help develop~          / upgrade brain monitors that could tell the anesthesiologist the patient's level of~          consciousness and prediction of arousal.~        3. A detailed reproducible mapping of the arousal process may serve as the core of a drug~          screening platform for drugs that may expedite patient arousal.~        4. Elucidation of the arousal paradigm from sedation will enhance our knowledge of~          physiological sleep.~      Research hypothesis~      Return of consciousness is a complex phenomenon comprising of interplay between the cortex~     and deeper brain structures. We hypothesize that the activation signature is conserved and~     similar between subjects. Furthermore, we hypothesize that inter-subject variability will~     arise mainly in the time domain, as evident from the clinical observation of variable time to~     emergence in different patients.~   "
100349|NCT02253745|"~     The purpose of this research study is to evaluate the safety, tolerability, effectiveness,~     and pharmacokinetics (PK) of twice daily oral doses of V81444 in adults with ADHD.~     Pharmacokinetics (PK) is the study of how a drug is absorbed, distributed, metabolized, and~     eventually eliminated by the body. Pharmacokinetics is what the body does to the drug. Blood~     samples will be taken throughout the study for PK analysis.~   "
100350|NCT02253732|"~     The purpose of this study is to determine specific changes in muscle secretory profile~     (myokines, miRNA) in association with neurodegenerative disease progression and metabolic~     dysfunction. Next the investigators would like to determine the shift in the muscle secretory~     activity induced by regular exercise intervention, which the investigators think could be~     translated into the beneficial changes in clinical phenotypes, determined by neuroimaging,~     cognitive function tests and metabolic phenotyping.~   "
100351|NCT02253719|"~     The prevalence of cervical neoplasia in Cambodia is not known. There are no screening~     programs in place. The investigators plan on introducing a screening program based on WHO~     criteria and utilizing visualization with acetic acid. Patients who are positive will be~     offered same-day cryotherapy if indicated or will be referred for biopsy, LEEP and~     hysterectomy as indicated. The planned patient pool for this study is 1000 women, half of~     whom will be HIV positive (and thus have a presumed higher incidence of cervical neoplasia).~   "
100352|NCT02253706|"~     In general bronchoscopy is a safe procedure with low rate of complications. Indeed,~     contraindications to flexible bronchoscopy are mostly relative rather than absolute. This is~     the case of preexisting decreased blood oxygen levels which may be present in patients~     requiring further bronchopulmonary investigation. To avoid the deleterious effects of oxygen~     drops oxygen supplementation is recommended.~      The purpose of this study is to evaluate the efficiency and safety of oxygen supplementation~     obtained with the use of a high flow nasal cannula compared with a low flow nasal cannula~     during flexible bronchoscopy.~      Consecutive patients referred by their treating physician for bronchoscopy will be offered to~     take part in the study. Those who wish to participate and give their consent will be randomly~     assigned into one of two treatment groups (supplemental oxygen given via low flow nasal~     cannula or via high flow nasal cannula).~      Assignment to either treatment arm will not affect in any way the intended purpose of the~     bronchoscopy. All patients will be closely monitored during the procedure and 2 hours~     following its completion. Monitoring will be conducted, using strictly non-invasive measures.~   "
100353|NCT02253693|"~     Research Question: Does an specific and pre-defined physical exercise prescribed by a~     specialist provide any benefit on haemophilic arthropathy, the quality of life or the~     physical condition of patients with haemophilia A and haemophilic arthropathy? Does adherence~     to physical exercise improve when monitoring patients with an accelerometer? Do compliant~     patients find higher benefit on haemophilic arthropathy, quality of life or the physical~     condition than non-compliant patients?~      Primary Endpoint: Assess in patients with haemophilia A and haemophilic arthropathy if a~     prescribed and specific physical exercise monitored by an accelerometer is producing any~     change in the following domains: progress of haemophilic arthropathy; health-related quality~     of life; physical condition.~      Secondary Endpoints: Evaluate the adherence to physical exercise in patients with haemophilia~     A and haemophilic arthropathy by means of accelerometry, and asses if compliant patients~     achieve higher improvement in these 3 domains than non-complaint patients.~   "
100354|NCT02253680|"~     The use of compression bandages in elective orthopaedic knee surgery is well regarded,~     however, there is a lack of robust, well-designed evidence to support this.~      The aim is to determine the feasibility of conducting a randomised control trial comparing~     the use of a compression bandage worn post-operatively for 24 hours after elective total knee~     replacement, compared to standard practice (wool and crepe, non-compressive dressing).~   "
100356|NCT02253654|"~     The purpose of this study is to compare two different dosing methods of epoetin alfa and~     their effectiveness in maintaining hemoglobin levels between 10.0 to 11.0 g/dL in in patients~     with chronic kidney disease (CKD) receiving hemodialysis.~   "
100357|NCT02253641|"~     This study evaluates the efficacy of a stress-focused tailored weight loss intervention~     compared to a standard weight loss intervention on weight loss in severely obese (BMI > 40.0)~     African American women.~   "
100358|NCT02253628|"~     This study investigated the acute effect of the consumption of four different kinds of coffee~     (hot and cold instant coffee, cold espresso and hot filter coffee) with the same caffeine~     content on salivary gastrin, cortisol and alpha-amylase concentrations, on self-reported~     gastrointestinal symptoms and on psychometric assessments in healthy individuals.~   "
100374|NCT02253420|"~     To evaluate the effect of itraconazole or rifampin on the absorption, distribution,~     metabolism and elimination of COPANLISIB (BAY80-6946) To evaluate the effect of copanlisib on~     QT/QTc intervals and left ventricular ejection fraction as parameters of cardiovascular~     safety~   "
100979|NCT02245555|"~     Study to describe Tamsulosin prescription characteristics in a representative population of~     patients on treatment for benign prostatic hyperplasia~   "
100359|NCT02253615|"~     The latest randomized controlled trials and systematic reviews of resistance training~     performed by older adults reported that the systematic use of exercise in machines improves~     muscle strength and power, functional abilities, body mass and body balance. However, the~     effect of resistance training with elastic tubes exercises have not been studied in all the~     variables described above. The objective of this study is to analyze the effects of elastic~     tubes exercises on muscle mass, muscle strength, functional performance and postural control~     in elderly untrained.~   "
100360|NCT02253602|"~     The current standard treatment of resectable esophageal cancer consists of neoadjuvant~     chemoradiation followed by resection. However, some patients develop recurrent disease~     despite chemoradiation and additional (systemic) treatment might have been indicated. Other~     patients show a (nearly) complete response after chemoradiation and could possibly have been~     treated with a less extensive treatment regimen. In patients without a threatened~     circumferential resection margin (CRM) and lymph node metastases chemoradiotherapy could~     possibly be omitted.~      Better stratification of patients with esophageal cancer is therefore urgently needed.~     Functional magnetic resonance imaging techniques (MRI) can provide in vivo, quantitative~     information on tumor biology and may prove to be a useful non-invasive tool for this purpose.~     In this project, ultra-small superparamagnetic particles of iron oxide (USPIO) enhanced MRI~     using ferumoxytol (Rienso®), diffusion weighted MRI (DWI) and T2* MRI will be developed, both~     in terms of improvement of acquisition and data processing techniques.~   "
100361|NCT02253589|"~     Healthy khat user with the intention to reduce or stop khat use will be randomly assigned to~     a one-session brief intervention or waiting list. Reductions in khat use will be measured~     from pre- to post-assessment which will be one month apart. After one month, the waiting list~     will receive the same intervention.~   "
100362|NCT02253576|"~     Study Design: This randomized, double blind, controlled, multi-centre study will occur in the~     Emergency Department, hospital-based Urgent Care Centre or paediatric outpatient clinics~     (collectively ED) of 3 General Hospitals in Ontario and 1 in British Columbia.~   "
100363|NCT02253563|"~     Comparison of resistance training versus balance training to improve postural control in~     patients with Parkinson's Disease~   "
100364|NCT02253550|"~     This study will look at the safety and efficacy of 8 week and 12 week treatment with~     Sofosbuvir and Simeprevir in treatment-naïve and treatment-experienced patients with chronic~     hepatitis C genotype 4.~   "
100365|NCT02253537|"~     To compare the results of the investigational test to the currently approved QuantiFERON-TB~     Gold In-Tube test.~   "
100366|NCT02253524|"~     -  Vertigo complaint is one of the common cause of patients who applied to emergency~          services.~        -  Patients who have applied to emergency services with vertigo complaint mostly have~          nausea as an additionally symptom to this complaint and anti-emetic agents can be used~          in their treatments very often.~        -  The investigators purpose is to investigate the advantages of Dimenhydrinate and~          metoclopramide to each other in the treatment of vertigo and the vertigo accompanied by~          nausea~   "
100367|NCT02253511|"~     Hepatocellular carcinoma (HCC) is one of the most common malignances seen in different~     regions of the world. The 5-year risk of recurrence of HCC after resection has been reported~     to be as high as 70%. It has been proposed that best way to reduce recurrence is to search~     for improved adjuvant therapies. Especially for some postoperative patients who were~     identified with the risk factors for recurrence, several adjuvant therapies were often used,~     including TACE. Recently, a variety of Traditional Chinese Medicine combined with TACE for~     toxicity reduction and enhancing the efficacy have been investigated in the treatment of HCC.~     Cidan capsules are a formula containing more than ten types of plant extracts, and has been~     clinically used for >10 years as a safe and nontoxic antitumor drug. However, the safy and~     efficacy of preventive therapy is still not clear. In this prospective control study, we~     enroll such HCC patients experienced operation and were identifed with high risk of~     recurrence. After a preventive TACE, the eligible patients were divided into two groups. One~     group will accept Cidan therapy and another will not. Under a basis of large sample, the~     safty and efficacy of Cidan combined with TACE in HCC patients will be investigated and~     analysed.~   "
100368|NCT02253498|"~     The purpose of this clinical study is to verify the long term effectiveness and safety of a~     bilateral deep brain stimulation (DBS) produced by Beijing PINS Medical Co., Ltd. as a~     treatment option for patients with cognitive, behavioral, and functional disability of~     Tourette Syndrome.~   "
100369|NCT02253485|"~     Mother-to-child transmission (MTCT) is the most common route of hepatitis B virus (HBV)~     infection. After given standard immunoprophylaxis, MTCT still occurred in some infants born~     to a HBsAg positive mothers with high HBV DNA load. The main purpose of this study is~     evaluating the efficacy of methods used in blocking MTCT of HBV in infants born to a HBsAg~     positive mothers with high serum HBV DNA loads.~   "
100370|NCT02253472|"~     The purpose of this clinical study is To verify the long term effectiveness and safety of a~     bilateral deep brain stimulation (DBS) produced by Beijing PINS Medical Co., Ltd. as a~     treatment option for patients with cognitive, behavioral, and functional disability of~     Obsessive-Compulsive Disorder.~   "
100371|NCT02253459|"~     The purpose of this study is to determine whether UTD1 Injection in combination with~     capecitabine is effective in the treatment of advanced metastatic breast cancer using~     capecitabine as a control.~   "
100372|NCT02253446|"~     -  Currently, nonsteroidal antiinflammatory drugs are widely used by emergency physicians~          in Turkey for the treatment of patients with Primary Dysmenorrhea.~        -  The objective of the study is compare intramuscular Diclofenac sodium and piroxicam's~          pain reduction dysmenorrhea in emergency department (ED) adults.~        -  The investigators second aim was to compare recurrent dysmenorrhea pain within 24 hours~          after discharge.~   "
100373|NCT02253433|"~     The purpose of this study is to improve the health of African-American adults who have poorly~     controlled asthma. The study will compare a home-based exposure reduction and asthma control~     intervention to enhanced in-clinic care that includes a standard clinical appointment as well~     as information from a detailed exposure history, asthma education, assessment for allergies,~     and a customized asthma self-management plan developed using motivational interviewing. The~     interventional group receives enhanced in-clinic care, as well as a customized home-based~     environmental exposure assessment and multicomponent exposure reduction and asthma control~     intervention (five home visits over approximately 12 months).~   "
100375|NCT02253407|"~     This is a study planned to determine and compare immunogenicity and reactogenicity of MMR~     vaccine of SIIL delivered either with disposable-Syringe Jet Injector (DSJI) or~     disposable-syringe needle in total 340 Indian infants aged 15 to 18 months.~   "
100376|NCT02253394|"~     The purpose of this study is to find out if spironolactone added to ambrisentan for Pulmonary~     Arterial Hypertension (PAH) will increase exercise capacity. We also want to find out if~     spironolactone and ambrisentan effect the cardiac output (amount of blood the heart pumps~     every minute), right ventricle function and quality of life.~   "
100377|NCT02253381|"~     Hypotension is the most common complications after spinal anesthesia especially in pregnant~     patients who undergoing cesarean section. Position during spinal anesthesia may be altering~     the hemodynamic. For right lateral decubitus, the enlarged uterus compresses inferior vena~     cava that may decrease venous return and cardiac output. This leads to hypotension.The~     hypothesis is the right lateral position during spinal anesthesia in pregnant women will be~     had hemodynamic changing more than the left lateral position. This objective is to compare~     hemodynamic change between left and right lateral position during spinal anesthesia in~     pregnant women undergoing cesarean section.~   "
100378|NCT02253368|"~     Bedtimes and wake-up times vary from person to person. The aim of this research is to examine~     the associations between sleep habits and metabolism in healthy people. In this study, the~     investigators will collect information on sleep-wake habits and how the body uses energy.~   "
100379|NCT02253355|"~     Evaluate the effects and safety of Deep Brain Stimulation (DBS) to treat on patients with~     Treatment-Resistant Depression (TRD) and using functional magnetic resonance imaging (fMRI)to~     evaluate the influence of acupuncture on patients, which will be afford objective evidence~     for the mechanism of Acupuncture on depression.~   "
100380|NCT02253342|"~     This study to determine and compare plasma, epithelial lining fluid (ELF) and alveolar~     macrophage (AM) concentrations of levonadifloxacin after administration of WCK 2349 in~     healthy adult subjects.~   "
100381|NCT02253329|"~     In the present study, the effect of a bolus of intrinsically labeled milk directly after~     one-legged NMES (Neuromuscular Electrical Stimulation) will be studied under two conditions:~     during the day and prior to sleep~   "
100382|NCT02253316|"~     The purpose of this research study is to evaluate a treatment regimen called IRD which will~     be given to participants after their stem cell transplant in an effort to help prolong the~     amount of time the participants are disease-free after transplant. IRD is a three-drug~     regimen consisting of ixazomib, lenalidomide (also called Revlimid), and dexamethasone. After~     4 cycles of IRD, the participants will be randomized to receive maintenance therapy either~     with ixazomib or lenalidomide.~   "
100383|NCT02253303|"~     The purpose of this study is to evaluate the midline extraction incision in patients with~     colon cancer. A prospective randomized controlled trial is conducted to compare midline~     extraction incision with off-midline extraction incision.~   "
100384|NCT02253290|"~     This project is a retrospective and prospective investigation of neuropsychological and~     psychosocial development of children with a neuromuscular disease.~   "
100385|NCT02253277|"~     In this study it is the rationale to evaluate the safety and tolerability of the combined~     administration of nilotinib and increasing dose of ruxolitinib in patients with chronic~     myeloid leukemia and patients with Philadelphia positive acute lymphoblastic leukemia.~   "
100386|NCT02253264|"~     Multiple sclerosis (MS) is a chronic inflammatory disorder affecting the central nervous~     system that is characterized pathologically by focal demyelinating lesions in the brain~     parenchyma. Meningeal inflammation in MS was first noted in 2004. Ectopic lymphoid follicles~     were described in the meninges of patients with secondary progressive MS (SPMS) and were~     thought to correlate with cortical lesions and atrophy (a surrogate marker for disability).~     Subsequently, inflammation in the meninges has been described in primary progressive MS~     (PPMS) as well as early relapsing MS.~      The ectopic lymphoid follicles are composed of B-cells, T follicular helper cells and~     follicular dendritic cells. Rituximab is a monoclonal antibody against CD-20 (a B-cell~     marker) that is FDA approved for the treatment of various lymphomas. Intrathecal (IT)~     rituximab administration has been used in central nervous system (CNS) lymphoma to achieve~     greater cerebrospinal fluid (CSF) concentrations of rituximab. In MS, IT administration of~     rituximab could lead to higher CSF rituximab levels resulting in the disruption of meningeal~     ectopic lymphoid follicles, ultimately reducing cortical lesions and possibly disease~     progression.~      The investigators hypothesize that IT rituximab therapy in patients with progressive forms of~     MS could disrupt ectopic lymphoid follicles in the meninges and thus slow progression of the~     disease, which is particularly important because there exist no FDA-approved therapies for~     progressive MS. The investigators hypothesize that using magnetic resonance imaging (MRI) to~     identify those with enhancing meningeal lesions will provide a biomarker to select patients~     who might be most likely to respond to IT rituximab and to use these lesions to monitor~     therapeutic response.~      The primary aim of this study is to assess the safety of intrathecal administration of~     rituximab in patients with progressive MS. The secondary aims are to evaluate if IT rituximab~     leads to a decrease in the quantity of meningeal lesions on MRI or to changes in biomarkers~     of inflammatory activity or neuronal injury in the CSF.~   "
100387|NCT02253251|"~     The investigators will recruit and enroll individuals that may have the KRAS-variant or other~     microRNA binding site mutations to join registry studies. The investigators will allow~     individuals to obtain their results through a physician at the completion of the studies. The~     investigators current focus is cancer and autoimmunity.~   "
100388|NCT02253238|"~     The goal of this research study is to learn if home-use of devices to identify dehydration~     risk, when added to standard care, will help to lower hospitalizations and emergency room~     visits (and related costs) in patients with head and neck cancer.~      CYCORE is a software-based system that enables comprehensive collection, storage and analysis~     of information related to cancer research and clinical care. In this study, those in the~     CYCORE group use devices at home to measure their dehydration risk. This information is~     monitored by their clinicians. Those in the standard care group complete health based~     surveys, as do those in the CYCORE group.~   "
100389|NCT02253225|"~     The investigators propose to examine both resting state activity and functional activity~     during rumination and during self-processing to study the relationship between neural~     correlates of rumination/self-focus and self-processing in major depression and bipolar~     disorder.~   "
100390|NCT02253212|"~     PURPOSE: The purpose of this study is to determine whether transient opening of the~     blood-brain barrier by pulsed ultrasound using the SonoCloud implantable ultrasound device is~     safely tolerated in patients with recurrent glioblastoma immediately before systemic delivery~     of carboplatin-based chemotherapy.~      STUDY HYPOTHESIS: The blood-brain barrier can be safely opened using pulsed ultrasound prior~     to chemotherapy administration in patients with recurrent glioblastoma. Transient opening of~     the blood-brain barrier by pulsed ultrasound will increase the glioblastoma exposure to~     carboplatin-based chemotherapy and increase progression-free and overall survival in patients~     with recurrent glioblastoma.~   "
100391|NCT02253199|"~     Increasing evidences suggest that dexmedetomidine Pharmacokinetic are different in children.~     We performed a up-down sequential allocation study to determine the ED50 for rescue sedation~     following sedation failures in children and to investigate age-related differences in the~     rescue sedation with dexmedetomidine.~   "
100392|NCT02253186|"~     The objective of the study is to assess the effect of a new Armsleeve, worn during the night~     during maintenance phase of upper limb lymphoedema treatment in combination with Day-time~     usual lymphology hosiery.~   "
100393|NCT02253173|"~     This study will assess the safety and efficacy of a new formulation of vaginal estradiol for~     the treatment of symptoms of vulvar and vaginal atrophy in postmenopausal women.~   "
100394|NCT02253160|"~     The purpose of this prospective, randomized, cross-over, multi-center study is to evaluate~     the performance of the Spectra Optia Apheresis System's CMNC Collection Procedure, compared~     to the COBE Spectra Apheresis System's MNC Procedure in mobilized healthy donors. Subject~     safety will be evaluated beginning with mobilization, throughout the collection procedure and~     for the day following the last collection.~   "
100395|NCT02253147|"~     The purpose of this study is to compare the effectiveness and safety of TEOSYAL® RHA Ultra~     Deep versus Perlane-L® in the treatment of moderate to severe nasolabial folds. This is a~     controlled, randomized, double-blinded, within subject (split-face), multicenter, prospective~     clinical study.~   "
100396|NCT02253134|"~     The purpose of this study is to evaluate the diagnostic yield (at 1 month post enrollment) of~     an external loop recorder (SpiderFlash-T) in patients with syncope or palpitations of~     suspected arrhythmic origin, within 30 days before enrollment.~   "
100397|NCT02253121|"~     Purpose of this study is to treat glucocorticoid induced hyperglycemia due to glucocorticoid~     pulse therapy in a efficacious, safe and convenient way. Patients with acute exacerbation of~     COPD treated with glucocorticoid pulse therapy and at high risk for glucocorticoid induced~     hyperglycemia (defined as known type 2 DM or glucose > 10mmol/l at admission) will be~     randomized to treatment of dapagliflozin or placebo orally, once daily.~      Percentage of time within glucose target range (3,9-10 mmol/l) and incidence rate of~     hypoglycemia will be compared between dapagliflozin group and placebo group.~   "
100398|NCT02253108|"~     The purpose of this study is to compare early vessel healing after implantation of SYNERGY~     drug eluting stent (DES) or BioMatrix NeoFlex DES at one and three months in two cohorts.~   "
100399|NCT02253095|"~     Randomized, double-blind, placebo controlled trial of a combined intervention of zinc,~     albendazole, and multiple micronutrients in improving environmental enteropathy in Malawian~     children.~   "
100400|NCT02253082|"~     Effects of OctaplasLG® on endothelial integrity in patients undergoing emergency surgery for~     thoracic aortic dissections - a randomized, controlled, single-blinded investigator-initiated~     pilot trial~   "
100401|NCT02253069|"~     To study the effect of applying a PHMB-based antiseptic solution to tie-over dressings in~     full-thickness surgical wounds in dermatologic surgery in order to minimise the development~     of surgical site infections. The bacterial dynamics in wounds pre-,intra-, and~     postoperatively will be examined in order to understand the pathogenesis of surgical site~     infections better.~   "
100402|NCT02253056|"~     The aim of this pilot study is to evaluate the effects of one regular fasting day per week~     over a total period of 8 weeks compared to a normal-eating habits among healthy volunteers.~   "
100403|NCT02253043|"~     Purpose: The purpose of this clinical study is to verify the long term effectiveness and~     safety of a bilateral deep brain stimulation (DBS) produced by Beijing PINS Medical Co., Ltd.~     as a treatment option for patients with cognitive, behavioral, and functional disability of~     Alzheimer's disease.~   "
100404|NCT02253030|"~     The primary goals of this study are to use optical coherence tomography (OCT) angiography~     (blood vessel mapping) to:~        1. diagnose the presence of new blood vessels in wet age-related macular degeneration (AMD)~        2. evaluate patients undergoing treatment for wet AMD~        3. determine if reduced flow to the choroid is a risk factor for developing wet AMD.~   "
100405|NCT02253017|"~     The purpose of this observational study is to assess the therapeutic strategies in the~     treatment of pediatric cataracts.~   "
100406|NCT02253004|"~     In a double blind placebo-controlled cross-over study the effect of cilostazol on aura~     induction and endothelial response is tested in patient with migraine with aura.~   "
100407|NCT02252991|"~     This trial will measure the fatigue in breast cancer patients.~      Two groups of patients will be realised:~        -  Arm A: Physical activity during treatment~        -  Arm B: No physical activity during treatment but after~      The aim of the study is to decrease fatigue, with adequate physical activity, in primary~     breast cancer patients who receive a treatment for their pathology.~   "
100408|NCT02252978|"~     This phase II trial studies ciprofloxacin compared to an inactive treatment (placebo) in~     diagnosing prostate cancer in patients undergoing removal of prostate cells or tissues for~     examination (biopsy). Ciprofloxacin is an antibiotic, a type of drug used to treat infections~     caused by bacteria. Giving ciprofloxacin to patients undergoing a prostate biopsy may help to~     lower abnormal prostate-specific antigen (PSA) levels caused by bacterial infection of the~     prostate gland and may or may not affect the detection rate of prostate cancer.~   "
100409|NCT02252965|"~     This is a Phase 4, prospective, open label, randomized, parallel controlled multicenter trial~     in which metformin extended release (XR) will be compared with metformin immediate release~     (IR) for the gastrointestinal tolerability and efficacy in the newly diagnosed subjects with~     Type 2 diabetes who have glycosylated hemoglobin (HbA1c) value between 7.0 to 10.0 percent~     (%).~   "
100410|NCT02252952|"~     The purpose of this study is to investigate the effects of consumption of sugar sweetened and~     diet beverages on overall fat mass and the fat mass of various tissues implicated in the~     dysregulation of glucose metabolism. In addition, hypothalamic activity will also be~     investigated after acute exposure to sugar sweetened and diet beverages, and again after 6~     months of daily consumption.~   "
100411|NCT02252939|"~     The investigators are doing this research study to discover factors, such as job, hobbies, or~     race that are associated with arthrosis at the base of your thumb on X-rays. Thumb arthrosis~     is one of the most common kinds of arthritis. About 116 people will take part in this~     research study at Massachusetts General Hospital (MGH).~   "
100412|NCT02252926|"~     Oral mucositis is a damage to the mucosa of the oral cavity and pharynx. It is a serious and~     painful adverse effect caused by the radio therapy and/or chemo therapy patients with head~     and neck cancer receive. The pain caused by oral mucositis can be difficult to treat as the~     current treatment with opioids is not sufficient and can cause adverse effects.~      Our hypothesis is that treatment with a local anesthetic lozenge with bupivacaine can reduce~     the oral pain caused by mucositis compared with the current standard treatment.~   "
100413|NCT02252913|"~     The purpose of this study is to evaluate the safety and tolerability of volitinib in~     combination with docetaxel in patients with locally advanced or metastatic gastric cancer and~     to determine the Maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of~     volitinib in combination with docetaxel.~   "
100414|NCT02252900|"~     Primary objective: To describe the evolution of cerebral lesions in IE patients (number of~     patients with abnormal cerebral MRI in acute phase of IE and during follow-up).~   "
100415|NCT02252887|"~     The purpose of this study is to see if a combination of drugs can help to treat breast~     cancer. This is a Phase II study which will test whether this combination of drugs is~     effective and will provide further information on side effects and safety. A standard~     chemotherapy, gemcitabine, will be combined with 2 other drugs that target the HER2 receptor.~     The HER2 receptor is a growth protein on the surface of some breast cancer cells that~     provides messages telling the breast cancer cell to grow. The standard chemotherapy will be~     gemcitabine.. The other two drugs work against HER2. One is called trastuzumab (Herceptin)~     and it is commonly given to women with advanced and early HER2 positive breast cancer. The~     other drug, pertuzumab (Perjeta), is also given to women with advanced HER2 positive breast~     cancer. The drugs in this study are each individually approved for the treatment of~     metastatic breast cancer. However, this study is looking at the effectiveness of gemcitabine~     with trastuzumab and pertuzumab when given to women who have advanced HER2 positive breast~     cancer who have had prior trastuzumab + pertuzumab or pertuzumab-based therapy.~   "
100416|NCT02252874|"~     This project is aimed to find out whether action video games can enhance dynamic visual~     function and improve balance function in the community-dwelling older adults. It is also~     aimed to examine the relationship between dynamic visions and balance functions.~   "
100417|NCT02252861|"~     Patients with atrial fibrillation are exposed to a high risk of thrombus in the left atrium~     that can induce cerebral vascular events or systemic embolisms. This justifies the~     prescription of anticoagulant therapies in patients with high risk of thromboembolic event.~     Percutaneous left atrial appendage closure is a new interventional strategy for patients with~     high risk of cardiovascular events and a counter-indication for long term treatment with~     anticoagulant agents. However, only few data are available on effectiveness and prognosis of~     patients treated by this new interventional strategy.~      This national database record per-procedure and follow-up data of patients treated by left~     atrial appendage closure.~      This database is strictly observational.~      Percutaneous left atrial appendage closure is performed only for the purpose of patient care.~     No specific intervention is performed specifically for the database. Neither left atrial~     appendage closure procedure nor patient follow up are modified by patient inclusion in the~     database.~   "
100418|NCT02252848|"~     Hypoxic ischemic encephalopathy (HIE) occurs in ~ 2-4/1000 term infants and is a major cause~     of neonatal morbidity and mortality. To date, therapeutic hypothermia started within 6 h of~     birth is the only intervention known to be effective in reducing the morbidity and mortality~     of HIE. Hypothermia does not totally reverse the injury in many infants and is associated~     with side effects that may compromise its effectiveness. Low dose morphine is often used to~     reduce shivering in infants undergoing therapeutic hypothermia, but escalating doses of~     sedatives/analgesics are often required. Escalating doses of opioids and benzodiazepines~     causes respiratory depression and can either cause the need for or prolong mechanical~     ventilation.Agonists to the central a2 - adrenergic receptors are more effective at reducing~     postoperative shivering than opioid receptor agonists and provide analgesia and sedation~     without respiratory depression. The most desirable sedative-analgesic agent used in infants~     with HIE would: (a) have an excellent safety profile, (b) reduce shivering, (c) provide~     adequate analgesia and sedation, (d) cause minimal respiratory depression, (e) preserve~     cerebrovascular autoregulation, and (f) confer neuroprotection.~   "
100419|NCT02252835|"~     The purpose of this study is to evaluate pharmacokinetics, pharmacodynamics, safety and~     potential for drug-drug interaction of arhalofenate when combined with febuxostat in adult~     population with gout.~   "
100420|NCT02252822|"~     Although 4.7% of adolescents suffer from symptoms of bulimia nervosa (BN), only 1/5 seek~     treatment. Hesitation to seek treatment is likely related to ego-syntonicity and fear of~     disclosing symptoms to parents and clinicians. Furthermore, the physical symptoms of BN often~     go unnoticed by parents and clinicians.~      In order to eliminate the barriers that prevent adolescents from seeking treatment, this~     study will offer anonymous access to online self-help cognitive behavioral therapy (CBT) for~     BN. Online CBT (traditional, non-anonymous delivery) has been found to be effective and~     acceptable treatment for adolescents with BN. Furthermore, in adults, this method has been~     found to be as effective as specialized treatments, and more cost efficient.~      To remain anonymous and accessible, the self-help approach in this study will be provided in~     a non-guided, or pure format (only online sessions). Studies support that a pure self-help~     methodology is as effective as a guided version.~      Although anonymity may improve accessibility, this study design could also pose challenges in~     areas such as recruitment, treatment completion and obtaining adequate informed consent.~     Therefore, before embarking on a larger randomized control trail, we would like to propose a~     small, non-controlled feasibility study to assess potential issues in these areas.~      Primary hypotheses:~      Recruitment: Based on communication with public health nurses in the high schools we plan to~     recruit from, we hypothesize that it is feasible to recruit 1-5 adolescents over a 4-month~     period from each of the 5 schools, and 1-5 from social media outlets such as Instagram,~     Twitter, Facebook for a total of 5 participants over a 4-month period.~      Treatment completion: Based on pervious studies of self-help for adolescent bulimia, we~     hypothesize that approximately 15% of participants will not complete any sessions, and many~     will only complete about half of the sessions.~      Informed consent: Based on information from large randomized control studies in the UK, we~     hypothesize that adolescents will be capable of providing online consent, and that we will be~     able to adequately obtain consent without verbally communicating with participants.~      Secondary hypothesis:~      We hypothesize a non-guided (pure) version of online CBT-BN offered in an anonymous manner~     will decrease BN symptoms after treatment completion, and at 3-month follow-up compared to~     baseline.~   "
100421|NCT02252809|"~     The main objective of this study is to characterize the biological responses elicited by~     endotoxin inhalation applied to healthy subjects, and to assess the effect of standard~     anti-inflammatory agents (i.e. adalimumab and methylprednisolone) on these biological~     responses.~   "
100422|NCT02252796|"~     This study will help researchers test the safety of hypofractionated dose of radiotherapy~     (HySBst) at different dose levels before or after chemo-radiation for Non Small Cell Lung~     Cancer.~   "
100980|NCT02245542|"~     Study to assess efficacy, tolerability and safety parameters of a three month ALNA®OCAS®~     -treatment with special respect to nocturia~   "
100423|NCT02252783|"~     BFPET will be evaluated as a diagnostic PET agent for assessing myocardial perfusion in~     subjects with known or suspected coronary artery disease (CAD) as compared to standard~     nuclear myocardial perfusion imaging (MPI). The safety of BFPET will be evaluated in known or~     suspected CAD subjects.~   "
100424|NCT02252770|"~     This is a study involving a dietary supplement. Patients with argininosuccinic aciduria will~     be randomly assigned to receive either a nitric oxide dietary supplement or placebo for 2~     weeks, and then crossed-over to receive the other treatment for two weeks.~      The investigators expect to see that : 1) Patients with ASA will have a decreased ability for~     their arteries to dilate due to nitric oxide deficiency, 2) Treatment of ASA with the nitric~     oxide supplement will improve the ability of their arteries to dilate, and 3) Through the~     testing of subjects' fibroblasts (cells in connective tissue that produce collagen and other~     fibers), the investigators hope to predict which patients may respond NO supplementation.~   "
100425|NCT02252757|"~     Heart failure is a common cardiovascular problem which is increasing in both prevalence and~     incidence and associated with substantial morbidity and mortality. The management of heart~     failure patients is complex and has become a priority world over. Effective methods to keep~     heart failure patients out of the hospital are essential, both in the interests of the~     patient's health, as well as to reduce the burden on the health care system~   "
100426|NCT02252744|"~     This study will evaluate the prevalence of dry eye disease in patients diagnosed with~     rheumatoid arthritis. No treatment is administered in this study.~   "
100427|NCT02252731|"~     This study will determine the effect of multiple doses of FG-4592 on the pharmacokinetics~     (PK) of a single dose of warfarin. It will evaluate the safety and tolerability of warfarin~     alone and in combination with multiple doses of FG-4592, and will evaluate the effect of~     multiple doses of FG-4592 on the pharmacodynamics (PD) of warfarin.~   "
100428|NCT02252718|"~     The aim of this study is to assess interobserver and intraobserver variability of the~     Amsterdam Stool Scale in clinical practice. After passing a stool by the child participating~     in the study it will be assessed using the Amsterdam Stool Scale independently by one of the~     parents and the medical doctor. At the same time a parent will take 2 photos that will be~     independently evaluated by another doctor.~   "
100429|NCT02252705|"~     Prospective multicenter registry including incident patients and prevalent patients which~     pretends to identify clinical characteristics, treatment trends in-hospital and four years~     follow-up outcome through major adverse cardiovascular events (MACE) in a Mexican population~     with well characterized Pulmonary Hypertension.~   "
100430|NCT02252692|"~     Phase I study in healthy adult male and female volunteers to compare the bioavailability of~     enalapril administered in orodispersible Minitablets with or without water in comparison to~     the standard galenic tablet formulation of enalapril. The standard pharmacokinetic parameters~     will be calculated from the bioanalytical results for enalapril and enalaprilat and compared~     in a descriptive statistical analysis.~   "
100431|NCT02252679|"~     The purpose of this study is to determine whether mass spectrometry analysis of stable~     (non-radioactive) calcium isotopes in plasma or urine samples can help in the diagnosis of~     bone and calcium disorders.~   "
100432|NCT02252666|"~     The investigators hypothesis is that electrical stimulation to the tongue that directly~     stimulates two cranial nerve nuclei (Trigeminal and Facial Nerve Nuclei), will excite neural~     impulses to the brainstem and cerebellum. The investigators call this cranial nerve~     non-invasive neuromodulation (CN-NINM). The activation of these structures induces~     neuroplasticity when combined with specific physical exercises, can reduce symptoms of~     advanced MS, targeting primarily postural stability (sitting and standing), upper extremity~     movement, and ability to perform self-transfers.~   "
100433|NCT02252653|"~     The purpose of this study is to characterize the frequency of TTR mutations in subjects~     suspected of having cardiac amyloidosis~   "
100434|NCT02252640|"~     The purpose of this study is to assess two types of new malaria vaccines in different~     combinations. The study will enable us to assess:~        1. The ability of the vaccines to prevent malaria infection.~        2. The safety of the vaccines in healthy participants.~        3. The response of the human immune system to the vaccines.~      We will do this by giving 48 participants three sets of vaccinations over 8 weeks, then~     exposing them to malaria infection by allowing mosquitoes infected with malaria to bite under~     carefully regulated conditions. We will follow participants closely to observe if and when~     they develop malaria. If the vaccine combination provides some protection against malaria,~     participants will take longer to develop malaria than usual or will not develop malaria at~     all. We will also recruit 4 individuals to be control subjects - these participants won't~     receive any vaccinations but will be challenged with malaria.~      Vaccinated volunteers who do not develop malaria infection in the blood after being infected~     with malaria by mosquito bite the first time may be invited back to be again infected with~     malaria in a repeat challenge experiment. This would happen approximately 5-7 months after~     the first challenge. The purpose of this second challenge will be to see how long the~     protection of the investigational vaccine against malaria lasts.~   "
100435|NCT02252627|"~     During operations to treat abdominal problems the blood pressure can fall, resulting in falls~     in blood flow to the vital organs. This fall can be treated by the administration of drugs~     that cause constriction of blood vessels. Although these drugs correct falls in blood~     pressure, it is unclear what effect they have on blood flow from the heart and to the vital~     organs.~      In this study of healthy volunteers we aim to better understand the changes in blood flow in~     both small and large vessels that occur in response to administration of these drugs. To do~     this we will use two different techniques of ultrasound imaging. A narrow (4-5mm) ultrasound~     probe will be inserted into the oesophagus via a nostril to measure blood flow in a major~     blood vessel. A second probe will rest on the abdomen and will record changes in blood flow~     in small vessels of the liver. Two drugs which raise the blood pressure via different~     mechanisms will be administered and the changes in flow from the heart and to vital organs~     will be measured and compared.~   "
100436|NCT02252614|"~     Comparition the analgesic effects of intravenous naproksen sodyum+codein with that of~     paracetamol+codein on postoperative pain and contramal consumption during the first 24 hour~     after a lumbar disk surgery.~   "
107086|NCT02165709|"~     Women undergoing surgical sterilization will be interested in risk reducing salpingectomy,~     and surgeons performing the procedure will be able to successfully complete the~     salpingectomy.~   "
100437|NCT02252601|"~     The purpose of this study is to find out whether the High Frequency Digit Triplet test can be~     used to screen patients with cystic fibrosis for hearing loss in conditions of health and~     pulmonary exacerbation. It is also designed to find out the youngest age at which a child can~     perform the test, the prevalence of hearing loss in a CF population and the prevalence of~     genetic mutations known to be associated with hearing loss in the same population.~   "
100438|NCT02252588|"~     Determine the effect of twice-daily chlorhexidine oral rinse on oral and lung microbiota~     biomass in subjects with chronic obstructive pulmonary disease (COPD) with chronic~     bronchitis. Our primary outcome will be to compare the microbiota biomass (number of bacteria~     as measured by 16S rRNA copy number) of induced sputum and the oral cavity before and after 8~     weeks of twice-daily chlorhexidine oral rinse (n=25) compared to controls (n=25) using qPCR~     and next-generation sequencing of the bacterial 16S rRNA gene comparing total bacterial~     biomass~   "
100439|NCT02252575|"~     E-Transportation is increasing all over the world. It is not known if the used engines~     interfere with cardiac implantable electronic devices. The study evaluates such potential~     interferences in vivo.~   "
100440|NCT02252562|"~     Healthcare-associated infections (HCAIs) and evolving bacterial resistance are major public~     health concerns that impact all areas of healthcare. Further work is needed to better~     understand these healthcare issues so that effective preventive measures can be developed.~      The investigators have developed and validated an experimental model for studying the risk~     factors for bacterial cross contamination in the surgical operating room. The investigators~     have confirmed in our previous work that intraoperative bacterial transmission events occur~     frequently both within and between surgical cases and that these transmission events are~     linked to 30-day postoperative HCAIs and increased patient mortality.~      In response, the investigators have implemented various strategies designed to bacterial~     transmission in the operating room, including anesthesia provider hand hygiene compliance.~     The investigators' recent work in the intensive care unit suggests that the hand hygiene~     system the investigators have previously studied could be further optimized.~      The investigators now propose to evaluate the effectiveness of a multimodal hand hygiene~     system enhanced with novel wireless technology designed to facilitate real-time group and~     individual performance feedback.~      The investigators hypothesize that the use of this system will increase hourly hand~     decontamination events of anesthesia and circulating nurse providers and reduce 30-day~     postoperative healthcare-associated infections HCAIs (primary outcome), reduce hospital stay~     duration, and hospital re-admission rates, and mortality(secondary outcomes).~   "
100441|NCT02252549|"~     This study is a multicenter randomized controlled trial in which the efficacy between SPIES~     assisted and WLI assisted TURB are compared. Subjects in the experimental arm (Arm A) will~     undergo SPIES assisted TURB, whereas subjects in the control arm (Arm B) will receive~     treatment with WLI assisted TURB only. Baseline characteristics will be recorded, as well as~     short and long-term follow up.~   "
100442|NCT02252536|"~     The purpose of this study is to determine whether gabapentin enacarbil is effective in the~     treatment of problems with alcohol.~   "
100443|NCT02252523|"~     This will be an open, prospective pilot study with pharmacological analysis. This study is~     designed to assess the efficacity and safety of dexmedetomidine-based sedation in two~     subgroups of neurocritically ill patients requiring mechanical ventilation for more than 48~     hours. Those with or at risk for intracranial hypertension requiring deep sedation and those~     requiring a light to moderate sedation for early neurological evaluation.~      The main objective is to assess the feasability of dexmedetomidine infusion in terms of~     efficacy and safety (especially cardiovascular tolerance) in brain-injured patients admitted~     to intensive care unit and requiring sedation and mechanical ventilation for a predictable~     duration greater than or equal to 48 hours. Secondary objectives include the study of~     hemodynamic parameters evolution, dose-response relationship, blood (+/- cerebrospinal fluid)~     drug concentration, opioates and co-hypnotic consumption.~   "
100444|NCT02252510|"~     It is proposed to measure sperm DNA damage by sperm chromatin dispersion test. This~     measurement helps to better diagnose male infertility and seems easy to apply in routine.~     However, the reliability of this method needs to be evaluated before applying for clinical~     practice in andrology laboratory.~   "
100445|NCT02252497|"~     The purpose of this study is to compare a single preoperative dose of 1g of tranexamic acid~     (TXA) versus a preoperative dose of 1g of TXA followed by a continuous infusion of 1g over~     height hours on blood loss.~   "
100446|NCT02252484|"~     The purpose of this study is to evaluate the effectiveness of a weight management program for~     men undergoing a prostatectomy by seeing if the program is easy to follow, impacts weight~     gain, and reduces risk of cancer recurrence in the participants.~   "
100447|NCT02252471|"~     This pilot study will: 1) demonstrate the feasibility of delivering CHOICES-TEEN with~     master's level mental health professionals within a juvenile justice setting; 2) determine~     acceptance of CHOICES-TEEN as measured by client adherence, retention, and treatment~     satisfaction; and 3) assess client improvement at 3-month follow-up (e.g., reduction of risk~     of HIV, nicotine-exposed pregnancy, and alcohol-exposed pregnancy).~   "
100448|NCT02252458|"~     The purpose of this study is to examine whether two clinically sensible dose regimen of~     fentanyl (low dose vs. high dose) lead to different pain scores as measured by the nonverbal~     rating scale (NRS) in healthy volunteers at 4.5 to 6.5 hours after fentanyl application. Pain~     modalities tested will include transdermal electrical stimulation and cold pressor pain.~      The investigators hypothesize that the high dose fentanyl group will have an increase of~     approximately 20% in the NRS.~   "
100449|NCT02252445|"~     The investigators want to evaluate the efficacy of the propofol and sevoflurane for the~     prevention of catheter-related bladder discomfort.~   "
100450|NCT02252432|"~     The purpose of this research is to determine the pain-reducing effects of ketamine (Ketalar,~     an FDA-approved drug for anesthesia) and methadone (Dolophine, a long-acting narcotic) after~     lumbar laminectomy. The investigators would like to evaluate whether intraoperative use of~     both drugs may be able to provide better control of pain after lumbar surgery.~   "
100451|NCT02252419|"~     The investigators want to evaluate the efficacy of the dexamethasone and paracetamol for the~     prevention of postoperative sore throat.~   "
100452|NCT02252406|"~     The purpose of this study is to determine the effects of ranolazine on different markers of~     cardiometabolic disease in women with stable angina and on angina frequency.~   "
100453|NCT02252393|"~     This randomized clinical trial studies intracorporeal or extracorporeal urinary diversion~     during robotic assisted radical cystectomy in reducing complications in patients with bladder~     cancer. Radical cystectomy is surgery to remove the entire bladder as well as nearby tissues~     and organs. After the bladder is removed, urinary diversion (a surgical procedure to make a~     new way for urine to leave the body) is performed. It is not yet known whether intracorporeal~     (within the body) or extracorporeal (outside of the body) urinary diversion is a better~     method in patients with bladder cancer undergoing robotic assisted radical cystectomy.~   "
100454|NCT02252380|"~     The proposed study is to evaluate the effectiveness of ExAblate Transcranial MRgFUS as a tool~     for creating a unilateral lesion in the Vim thalamus or the globus pallidus (GPi) in patients~     with treatment-refractory symptoms of movement disorders.~   "
100455|NCT02252367|"~     At present time several preclinical and clinical study have demonstrated the safety and~     efficacy of PDE5 (phosphodiesterase type 5)-inhibitors for LUTS/BPH (lower urinary tract~     symptoms/benign prostatic hyperplasia) patients with or without erectile dysfunction.~     However, the link between clinical outcomes (symptoms scores), functional activity~     (urodynamic findings) and molecular pathways, in particular regarding inflammatory pattern~     (molecular analyses), has not been previously investigated.~      Aim of present study is to assess, for the first time in literature, changes in pressure flow~     study (PFS) and changes in molecular profile of prostatic tissue (inflammatory and tissue~     remodeling markers) in men treated for 12 weeks with tadalafil 5 mg compared with placebo and~     to correlate these data with changes in symptoms scores (IPSS, International Prostatic~     Symptoms Score) in men with LUTS secondary to BPH refractory to alpha blockers.~   "
100456|NCT02252354|"~     The purpose of this 2 part study is to look at how TAK-385 is taken up, broken down and~     removed from the body when given as a radiolabelled oral solution (by mouth) or as an oral~     tablet (by mouth) followed by a radiolabelled intravenous (IV) infusion (into the arm vein).~   "
100457|NCT02252341|"~     Effects of N-Acetyl-Cysteine in patients with bipolar depression (primary outcome is Hamilton~     Depression Rating Scale) with and without tobacco use disorder and on inflammatory and~     oxidative stress biomarkers~   "
100458|NCT02252328|"~     The trial will compare the effect on disease control and immunosuppression treatment of~     adding simvastatin 80mg once daily, over a follow-up and treatment period of 2 years.~     Patients will be randomised in a 1:1 fashion to standard treatment with placebo or standard~     treatment with the addition of simvastatin (80mg daily). They will be followed at 3 months~     intervals for 2 years with a primary end point of mean reduction in corticosteroid dosage at~     the 12 month follow-up visit.~   "
100459|NCT02252315|"~     Mild traumatic brain injury (MTBI) is a common injury that involves loss of consciousness or~     alteration in mental status induced by an external mechanical force to the head. Education~     about symptoms and reassurance of a prompt recovery usually results in full recovery.~     However, a subgroup appears to have persistent symptoms and disability. This study will~     recruit MTBI patients from two Emergency Departments with the aim of identifying modifiable~     patient characteristics that can delay or prevent full recovery. A secondary aim is to~     determine if providing education in writing or in-person makes a difference.~   "
100460|NCT02252302|"~     When exposed to air pollution, the asthma symptoms are aggravated and lung function is~     impaired. Due to high breathing rates and volumes, physically active individuals are at~     particular risk of lung health impairment due to the high breathing rates and volumes.~     Greater doses of air pollutants reach deeper areas in the lungs where they can trigger~     asthma-symptoms. When treating these symptoms with inhaled beta-2-agonists the airways widen~     even more, allowing the air pollutants to reach even deeper areas of the lung. With this~     study the investigators investigate how inhaled beta-2-agonists affect athletic capacity and~     lung health in physically active asthmatics.~   "
100461|NCT02252289|"~     It is increasingly recognised that asthma is not a single disease but that there are many~     different phenotypes. Much of the work that we have previously carried out has focussed on~     differentiating children with difficult asthma (those whose asthma control improves with~     attention to the basics of asthma management such as adherence) from those with severe~     therapy resistant asthma (ongoing poor control despite high dose treatment and attention to~     the basics. Our collaborators in Basel, Switzerland have demonstrated that serial~     measurements of lung function (peak flow) in adults can characterise the severe asthma~     phenotype and its stability in adults with asthma. We plan to carry out twice daily peak flow~     measurement sin children with asthma using an electronic peak flow meter. We will analyse~     peak flow patterns in children with severe therapy resistant asthma (STRA), difficult asthma~     (DA) and mild to moderate asthma. We will also investigate the relationship between peak flow~     variations and symptoms, recorded in a daily diary and medication use, recorded by an~     electronic measuring device which attaches to the child's own inhaler (Smart-inhaler).~   "
100462|NCT02252276|"~     Objectives: To analyze the effects of proprioceptive and strengthening exercises versus the~     same exercises and manual therapy on the recurrent ankle sprain management.~      Design: A randomized clinical trial with two intervention groups and triple blind.~      Settings: University Hospital.~      Participants: Fifty-four patients with previous history of recurrent ankle sprains, regular~     sports practice and pain during the physical activity, randomly assigned to experimental or~     control group.~      Intervention: Control group performed 4 weeks of proprioceptive and strengthening exercises;~     experimental group performed 4 weeks of the same exercises combined with manual therapy.~      Main Outcomes Measures: Pain, ankle instability, pressure pain threshold (PPT), ankle~     eversion strength, and active range of motion in ankle joint. The measures were taken before,~     after and one month after the interventions.~   "
100463|NCT02252263|"~     To assess the safety and tolerability, characterize the dose limiting toxicities (DLTs) and~     identify the maximally tolerated dose (MTD) of Elotuzumab administered in combination with~     either Lirilumab or Urelumab in subjects with multiple myeloma.~   "
100464|NCT02252250|"~     To investigates the feasibility, practicability, safety and subjective as well as functional~     outcome of transanal minimal invasive surgery toal mesentery excision for rectal cancer.~   "
100465|NCT02252237|"~     The purpose of this study is to determine individual susceptibility factors (drug~     interactions, genetic factors such as enzyme polymorphism…) to explain wide interindividual~     variability towards corticosteroids (prednisone, prednisolone, methylprednisolone) in~     children, which could establish a base for therapeutic monitoring.~   "
100466|NCT02252224|"~     This surveillance is a postmarketing commitment following the marketing authorization for~     Forxiga(dapagliflozin) in accordance with Standards on Re-examination of New Drugs, notified~     by the MFDS under Article 32, Paragraph 1 and Article 37, Paragraph 3 of Pharmaceutical~     Affairs Law. MFDS requires that at least 3,000 patients who can be evaluated for safety~     assessment should be collected within 6 years from 26 Nov 2013 to 25 Nov 2019.~   "
100467|NCT02252211|"~     The purpose of this study is to find a more effective way of treating solid tumors. This~     study will test the safety, bio-distribution, and tumor uptake of a new treatment for cancer~     called DS-8895a in patients with advanced solid tumors.~   "
100468|NCT02252198|"~     Assess sensitivity and specificity of two nucleic acid amplification tests, namely Epistem~     Genedrive® and MolbioTruenat™ in raw sputum compared to the WHO-endorsed GeneXpert® MTB/RIF~     assay using a gold standard of four cultures~   "
100469|NCT02252185|"~     The primary objective of this study is to demonstrate that the efficacy and safety of Spine~     fusion system manufactured in China is no inferior than imported product.~   "
100470|NCT02252172|"~     The purpose of this study is to compare the efficacy of daratumumab in combination with~     lenalidomide and dexamethasone to that of lenalidomide and dexamethasone in terms of~     progression-free survival (PFS) in participants with newly diagnosed multiple myeloma (a~     blood cancer of plasma cells) who are not candidates for high dose chemotherapy (treatment of~     disease, usually cancer, by chemical agents) and autologous stem cell transplant (ASCT).~   "
100471|NCT02252159|"~     This is a Phase IV, multicenter, non-interventional, non-randomized, prospective,~     observational study in an adult population (patients >18 years old) of men and women who have~     been diagnosed with clinically overt PV and are being followed in either community or~     academic medical centers in the United States who will be enrolled over a 12-month period and~     observed for 36 months from the date the last patient is enrolled.~   "
100472|NCT02252146|"~     Recent reports have identified a specific oncogenic mutation L265P of the MYD88 gene in~     approximately 30% of the patients with the activated B-cell (ABC) type of Diffuse Large B~     Cell Lymphoma (DLBCL). MYD88 is an initial adapter linker protein in the signaling pathway of~     the Toll Like Receptors (TLRs), including the endosomal TLRs 7, 8, and 9, for which the~     ligands are nucleic acids. IMO-8400 is an oligonucleotide specifically designed to inhibit~     ligand activation of TLRs 7,8, and 9. Recent studies indicate that in the presence of L265P~     mutation ligand activation of those TLRs results in markedly increased signaling with~     subsequent increased cell activation, cell survival, and cell proliferation. The scientific~     rationale for assessing the use of IMO-8400 to treat patients with DLBCL and the L265P~     mutation is based on laboratory observations that IMO-8400 inhibits ligand-based activation~     of cells with the mutation and decreases the survival and proliferation of the cell~     populations responsible for the propagation of the disease.~   "
100473|NCT02252133|"~     The purpose of this study is to compare the lens centration of DAILIES TOTAL1® (DT1) contact~     lenses to 1-DAY ACUVUE® Tru-Eye® (1DAVTE) contact lenses in a Japanese population after 7 ± 2~     days of wearing of each product.~   "
100474|NCT02252120|"~     The investigators test the hypothesis that oropharyngeal leak pressure and fiberoptic~     position differ between the size 2 LMA SupremeTM and the Laryngeal Tube LTS IITM in~     non-paralyzed anaesthetized pediatric patients~   "
100475|NCT02252107|"~     This study examines whether the addition of decitabine to the standard Flu/TBI conditioning~     regimen prior to allogeneic stem cell transplantation in poor and very poor risk AML~     patients, reduces the risk of recurrence of the disease. Because decitabine has hardly any~     side effects, it will likely have little impact on the occurrence of Graft Versus Host~     Disease. The investigators are looking for a pre-treatment for transplantation which reduces~     the chance of recurrence of the disease without involving severe damage to normal tissues.~   "
100476|NCT02252094|"~     This study evaluates the use of ultra-protective ventilation, where very low ventilation~     volumes are used, in patients with severe acute respiratory distress syndrome (ARDS) meeting~     criteria to nurse in the prone position. Half the patients will receive ultra-protective~     ventilation support by extracorporeal carbon dioxide removal, while the other half will~     receive conventional lung protective ventilation.~   "
100477|NCT02252081|"~     Chronic kidney disease (CKD) is a major global health problem associated with substantial~     costs and resource utilization. Currently, CKD affects more than 500 million people~     worldwide. Patients with CKD have unacceptably high mortality rates due to cardiovascular~     (CV) causes, which are not entirely explained by traditional CV risk factors. The mortality~     rates in advanced CKD are six times higher compared to the Medicare population, with CVD~     accounting for the overwhelming majority of deaths. Insulin resistance (IR) is common in CKD~     patients and may represent a central link between CKD and the increased CVD risk observed in~     this population. Insulin resistance may increase CV risk by impairing and worsening~     endothelial function, increasing reactive oxygen species, and exacerbating systemic~     inflammation-hence, insulin resistance is considered a non-traditional CV risk factor in~     CKD.~      Obesity (defined by a body mass index [BMI] of at least 30 kg/m2) is a major public health~     problem-the upward trend in obesity prevalence across regions and continents is a worldwide~     concern. Obesity increases the risk for cardiovascular disease and death. In the general~     population, obesity hastens death by 9.4 years. Obesity is an independent risk factor for~     CKD. Besides its contribution to the development of diabetes and hypertension, increased fat~     mass may also have a direct impact on kidney function.~      In spite of the increasing prevalence of both obesity and CKD, the impact of obesity in the~     CKD population is not known, especially in terms of the exaggerated metabolic disturbances~     associated with their coexistence. It is highly likely that these two conditions have~     profound interactions that exaggerate the severity of the metabolic derangements when they~     coexist, particularly in regards to adipokine dysregulation, the risk of insulin~     resistance, and downstream effects on vascular health. The current proposal will attempt to~     characterize the relative and combined impact of both obesity and CKD on metabolic~     disturbances, which may aid in risk stratification and identifying specific targets for~     intervention.~      The ultimate goal of this proposal is to understand the relative and combined impact of~     obesity and CKD on the generation and maintenance of insulin resistance and their impact on~     cardiovascular health.~      Specific Aim 2: To study the effects of metformin, an AMPK activator, on metabolic~     disturbances associated with obesity and moderate CKD.~      S.A.2.a: To test if metformin will improve LAR in obese patients with moderate CKD compared~     to placebo.~      S.A.2.b: To test if metformin will improve markers of systemic inflammation, oxidative~     stress, endothelial dysfunction in obese patients with moderate CKD compared to placebo.~      S.A.2.c: To test if metformin will improve atherosclerosis markers and reduce clinical CVD~     events in obese patients with moderate CKD compared to placebo.~      Hypothesis: The investigators hypothesize that the administration of metformin in obese CKD~     patients will significantly improve the adipokine profiles-particularly through a reduction~     in LAR. Additionally, that it will improve systemic inflammation, oxidative stress and~     endothelial function, which may or may not be mediated by changes in adipokines. Finally, the~     investigators hypothesize that improvements in these markers of vascular health will~     translate into reduced arterial stiffness and less clinical CV events~   "
100478|NCT02252068|"~     Anxiety is highly prevalent among individuals with opioid dependence and confers greater risk~     for continued opioid use and poor treatment outcomes. However, there are currently no~     efficacious treatments available for co-occurring opioid dependence and anxiety. The ultimate~     aims of this trial are the development and testing of a novel integrated cognitive behavioral~     treatment (I-CBT) for co-occurring opioid dependence and anxiety disorders. This clinical~     trial consists of two phases: (1) open-trial pilot (2) randomized control trial. We~     hypothesize that I-CBT will be a feasible and acceptable treatment that will result in~     significant reductions in anxiety and opioid use.~   "
100479|NCT02252055|"~     To collect evidence of the safety of administering autologous tolerogenic dendritic cells~     (ATDC) preparations to living-donor renal transplant recipients in the context of an~     international European Union funded consortium aimed at evaluationg cellular immunotherapy in~     solid organ transplantation (The ONE Study). It is anticipated that immune regulation induced~     by ATDC therapy can evntually be used to reduce the need for conventional immunosuppression~     in transplant recipients.~   "
100480|NCT02252042|"~     This is a study of pembrolizumab (MK-3475, KEYTRUDA®) versus standard treatment~     (methotrexate, docetaxel or cetuximab) for the treatment of recurrent or metastatic head and~     neck squamous cell cancer (HNSCC). Participants will be randomly assigned to receive either~     pembrolizumab or Investigator's choice of standard treatment. The primary study hypothesis is~     that pembrolizumab treatment prolongs overall survival when compared to standard treatment.~   "
100481|NCT02252029|"~     This study will establish the duration of excretion of rotavirus vaccine in stool following~     vaccination of premature babies hospitalised in a neonatal unit at the time of vaccination.~   "
100482|NCT02252016|"~     This is a randomized, multi-site, placebo-controlled trial of a fixed dose combination (FDC)~     of grazoprevir (MK-5172) 100 mg + elbasvir (MK-8742) 50 mg in participants with chronic~     Hepatitis C Virus (HCV) genotype (GT) 1, GT4 or GT6 with inherited blood disorders. The~     primary hypothesis is that the proportion of participants treated with grazoprevir+elbasvir~     achieving Sustained Virologic Response (SVR) 12 weeks after the end of all study therapy~     (SVR12) will be greater than the reference rate of 40%.~   "
100483|NCT02252003|"~     In clinical practice with young children, gold standard rating scales used to evaluate the~     pain are VAS (Visual Analogue Scale) and FPS-R (Faces Pain Scale - Revised), which are~     self-assessment tools. These scales present however certain limitations: the VAS is not~     applicable if the child does not know how to estimate the distances, as young children, or~     children with mental retardation. As for FPS-R, it can be frightening for children by the~     aspect of faces looking like impersonal masks.~      For children under 4 years, only hetero-evaluation based on typical behavioral scales as Face~     Legs Activity Cry Consolability (FLACC) can be used, according to the current~     recommendations.~      We thus wanted to create a new faces scale with teddy bear faces, which are cross-cultural~     and timeless. Our objective is to validate the new teddy scale in its paper shape on a wide~     sample of children. We made the hypothesis that the teddy scale would enable to evaluate the~     pain in the same way that the FPS-R, being better accepted and preferred by children.~      The first phase of this study will be to develop the teddy scale with a sample of 30 healthy~     children from 4 to 11 year-old, having already experienced pain. This stage allows the~     validation of the images chosen for the scale, to make sure of their relevance and their~     optimal recognition by the children.~      The scale will then be validated with a sample of 218 hospitalized children from 2 to 11~     years old, to whom pain is usually evaluated in a systematic way. Children from 4 to 11 years~     old will have simultaneously the teddy scale, the VAS and the FPS-R. They will be asked to~     determine which scale they preferred. Children from 2 to 4 years old will have the teddy~     scale; the FLACC will be filled in by parents.~      Tested hypothesis: The discriminating characteristic of the teddy scale is superior to that~     of the FPS-R scale The validation of the teddy scale will enable to objectify children's~     pain, to facilitate the decision-making in the choice of the analgesic to prescribe, and to~     check the efficiency of these decisions. This teddy scale could be used in current practice~     as a replacement of the FPS-R.~      Following this study, we planned to set up a second project in which the teddy scale will be~     adapted to electronic form (touchpads), to test its adaptability with the children.~   "
100484|NCT02251990|"~     This is a randomized, parallel-group, placebo-controlled, multi-site, multinational,~     double-blind followed by open label period, Phase 3 trial of 100 mg of grazoprevir (MK-5172)~     in combination with 50 mg of elbasvir (MK-8742) (grazoprevir/elbasvir fixed-dose combination~     [FDC]) in treatment-naïve (TN) participants with chronic hepatitis C virus (HCV), genotype~     (GT) 1, 4 or 6 infection. The primary hypothesis is that the percentage of participants~     receiving grazoprevir/elbasvir FDC in the Immediate Treatment Group (ITG) achieving Sustained~     Virologic Response 12 weeks after the end of all study therapy (SVR12) will be superior to~     the historical reference rate of 73%.~   "
100485|NCT02251977|"~     The primary objective of this study is to assess the efficacy of~     monosialotetrahexosylganglioside (GM1) for preventing oxaliplatin induced neurotoxicity in~     colorectal cancer patients who received oxaliplatin-based adjuvant chemotherapy.~   "
100486|NCT02251964|"~     This project will address rare immune mediated inflammatory diseases (IMIDs) involving the~     lungs, i.e. interstitial pneumonitis (IP). The main objective of this study is to assess the~     effects of rituximab (RTX) as a rescue therapy for progressive IMID-IP patients. The primary~     study parameter is pulmonary function.~      The secondary objectives are to explore the application of imaging with radiolabeled RTX as~     early predictor for efficacy of RTX, to study the effects of RTX treatment on quality of~     life, and to further elucidate the pathophysiology of IMID-IP by analyzing biochemical~     markers.~   "
100487|NCT02251951|"~     The investigators propose to study the efficacy and safety of nab-Paclitaxel in a Phase II~     trial of patients with locally advanced or metastatic adenocarcinomas of the stomach and~     gastro-esophageal junction~   "
100488|NCT02251938|"~     The objective of this extension study is to evaluate the long-term safety of treatment with~     DE-109 (440 μg) in subjects with non-infectious uveitis of the posterior segment of the eye~     who have participated in the SAKURA development program.~   "
100489|NCT02251925|"~     This study is a prospective randomized controlled trial to compare the pregnancy outcomes of~     frozen embryo transfer in natural and hormonal replacement cycles. The study population~     consisted of all infertile women with regular menstrual cycles who will undergo IVF/ICSI and~     frozen embryo transfer in Reproductive Biomedicine Research Center, Royan institute, Tehran~     Iran.~   "
100490|NCT02251912|"~     Purpose: Test whether oxytocin treatment decreases drinking in people who have been consuming~     alcohol heavily for long periods and are physically and psychologically dependent on alcohol.~      Participants: 50 adults with alcohol dependence~      Procedures (methods): Oxytocin or placebo will be administered three times a day for the~     first 2 days followed by twice daily intranasal doses for the rest of the 12 weeks. Before,~     during and at the end of the trial, each subject will undergo evaluations including~     breathalyzer readings, rating withdrawal symptoms, interviews about amount of alcohol~     consumed since last clinic visit, subject self-ratings of anxiety, alcohol craving and, at~     some visits, laboratory measures (blood and urine) to monitor safety and alcohol/drug use.~     Following the active phase of the trial, subjects will be followed up at 4 weeks and 12 weeks~     to evaluate for post-medication safety and efficacy~   "
100491|NCT02251899|"~     The aim of this study is to determine whether a nurse-managed telephone-based~     disease-management intervention can reduce healthcare utilization and improve self-assessed~     health status in patients with congestive heart failure.~   "
100492|NCT02251886|"~     Moxibustion was tested for version of a breech position in singleton pregnancies. The women~     were randomized in week 32 to either moxibustion on acupuncture point Bl 67 daily in 15-20~     minutes or no moxibustion. In week 36-37 the fetal position was checked and external cephalic~     version was offered for those still in breech position. The randomization was stratified for~     primigravida and multiparae separately. The randomization was made with a random number even~     and odd numbers indicating moxibustion or not. The randomization result was hidden in a~     sealed, non-transparent envelope on the obstetrical department and drawn when the woman gave~     informed consent to the study.~   "
100493|NCT02251873|"~     Study to characterise the effects of concurrent tipranavir (TPV) and ritonavir (RTV)~     administration on the single dose pharmacokinetics of didanosine (ddI), to characterise the~     effects of single-dose ddI on the pharmacokinetics of TPV and RTV and to assess the~     short-term safety of this combination~   "
100494|NCT02251860|"~     ARATA is a prospective, non-interventional, multicenter, observational study in Germany to~     evaluate the long-term effectiveness and tolerability of subcutaneously administered~     tocilizumab in participants with rheumatoid arthritis in daily clinical practice.~     Participants will be followed over an observation period of up to 2 years after the initial~     injection.~   "
100495|NCT02251847|"~     To evaluate efficacy and safety of a combination therapy of rosuvastatin and ezetimibe versus~     monotherapy of rosuvastatin in hypercholesterolemia patients~   "
100566|NCT02250924|"~     This is a randomized, three-arm, double-blind, placebo-controlled, Phase III clinical trial~     of caffeinated gum and sugar-less gum in adult patients after an abdominal procedure.~     Patients will be randomized to receive placebo, sugar-less gum or caffeinated gum three times~     daily for 30 minutes starting the day following surgery until discharge or 24 hours after~     attainment of the primary endpoint.~   "
100496|NCT02251834|"~     Stroke is a leading cause of death and functional impairments and stroke risk factors (SRFs)~     disproportionately affect Latino populations. In the Hispanic Secondary Stroke Prevention~     Initiative (HISSPI) the investigators propose a study using Community Health Workers (CHW)~     and mobile technologies using cell phones to reduce the risk for a recurrent stroke among~     Latino stroke patients.~      The project examines the effectiveness of a combined multilevel intervention consisting of~     Community Health Workers (CHW) and mobile based phone technologies in lowering of systolic~     blood pressure (SBP) which is the most important risk factor for recurrent stroke.~   "
100497|NCT02251821|"~     This phase II trial studies how well giving a JAK inhibitor before a donor stem cell~     transplant works in treating patients with myelofibrosis that developed without another~     condition (primary) or evolved from other bone marrow disorders (secondary). JAK inhibitors~     are a class of drugs that may stop the growth of abnormal cells by blocking an enzyme needed~     for cell growth. Giving a JAK inhibitor before a donor stem cell transplant may help reduce~     symptoms of myelofibrosis such as inflammation and enlargement of the spleen, improve the~     patient's general physical condition, and prevent complications from occurring after the~     transplant. Infusing healthy stem cells from a donor into the patient may help the patient's~     bone marrow work normally and make stem cells, red blood cells, white blood cells, and~     platelets. Giving a JAK inhibitor before a donor stem cell transplant may help improve~     transplant outcomes in patients with myelofibrosis.~   "
100498|NCT02251808|"~     This study will be done because the investigators would like to evaluate product satisfaction~     of two PINS products (product A, product B) that are to evaluate the effectiveness of~     rechargeable and non-rechargeable Deep Brain Stimulation (at baseline visit and at follow-up~     visit) and by evaluating their responses to the product satisfaction survey that will be~     given to them by a study coordinator.~   "
100499|NCT02251795|"~     Study to determine the effect of steady-state plasma concentration of Tipranavir/ritonavir~     (TPV/r) on platelet aggregation in healthy subjects and investigate the effect of TPV/r at~     steady state plasma concentrations on other platelet functions and biomarkers of coagulation~     and fibrinolysis.~   "
100500|NCT02251782|"~     Colorectal cancer (CRC) screening has been demonstrated to reduce long term disease burden~     and costs. Unfortunately, less than 65 % of age-eligible persons in the US are actually~     screened for CRC. The leading methods, colonoscopy and FIT (fecal immunochemical test)~     testing, both have patient-associated barriers that reduce their use. The combination of~     bowel preparation and procedure time are barriers to colonoscopy, while stool handling as~     part of the sampling protocol reduces FIT usage.~      It has been hypothesized and supported by a variety of preference studies that the~     availability of a blood-based assay for CRC screening would increase patient participation~     and adherence to CRC screening by reducing barriers that prevent participation.~      This study is designed to investigate the relative participation in CRC screening in average~     risk, screening eligible patients with demonstrated non-adherence to guideline-recommended~     screening modalities. Participation with the fecal immunochemical test (FIT) and the~     blood-based Epi proColon® test will be examined. Screening eligible average-risk patients~     identified as non-adherent by medical record will be eligible for the study. Potential~     subjects will be recruited to participate in a study via mailing and/or at a clinic visit.~     All study subjects will be enrolled at a clinic visit and will be randomized in two study~     arms. Those assigned to Arm 1 will be offered a FIT test kit for home use. Those assigned to~     Arm 2 will be offered a blood draw for the Epi proColon test. Rates of adherence will be~     compared between those that accept and complete the blood test and those that accept and~     complete the FIT test. A passive control, usual care arm will comprise subjects meeting~     eligibility criteria, but not recruited for or participating in the study.~      In conjunction with published data (Johnson et al, 2014), the relative utilization of the~     blood test will be compared to the screening participation via FIT. Increased participation~     with the Epi proColon blood test could increase screening rates in the non-adherent~     population. Additionally, for those testing positive in the trial, the rate of adherence to~     colonoscopy will be determined.~   "
100501|NCT02251769|"~     To determine the effects of single-dose and steady-state Tipranavir/Ritonavir (TPV/r) at 500~     mg/200 mg bid on the steady-state pharmacokinetics of clarithromycin and to determine the~     effects of a standard high-fat test meal on the steady-state pharmacokinetics of tipranavir.~   "
100502|NCT02251756|"~     Study objective To assess the performance of different application regimens of Actinica® on~     protection from UV rays-induced erythema throughout 1 day of sun exposure in fair-skinned~     healthy subjects (phototype I to III).~      Study centers A total of 20 subjects will be enrolled in 1 site in France.~      Methodology This will be a monocentre, randomised, controlled, investigator-blind,~     intra-individual comparative clinical investigation.~      There will be a total of 6 visits for each subject. Each subject will participate for a~     period of maximum 35 days.~      Study population Healthy subjects, male or female, at least 18-60 years old, with phototype~     I, II or III, not pre-treated/pre-protected skin, meeting specific inclusion/exclusion~     criteria.~      The clinical investigation will be conducted in 2 parts.~      Part 1 - SPF determination:~      To determine the SPF of Actinica® with application of two different amounts (0.8 and 2~     mg/cm2).~      Part 2 - Sun exposure:~      To assess the performance of the different application regimens of Actinica® on protection~     from UVR-induced erythema throughout 1 day of sun exposure.~   "
100503|NCT02251743|"~     Additional treatments with long-term benefit for attention-deficit/hyperactivity disorder~     (ADHD) are needed; one of the more promising is neurofeedback (EEG biofeedback), which has~     several randomized controlled trials showing significant benefit, but which are inconclusive~     because they were not double-blinded; the benefit could have been nonspecific (placebo~     response). Because of neurofeedback's labor-intensive cost (1 treatment costing as much as a~     month's medication), It is important to know how much specific benefit it yields. This 2-~     site placebo-controlled double-blind randomized clinical trial is the first to test for a~     specific benefit of neurofeedback with adequate power, the first designed and implemented~     collaboratively by experts in neurofeedback, ADHD, and clinical trials, the first to~     rigorously monitor quality not only of treatment, but also of placebo and blinding, and the~     first to follow up for 2 years to examine enduring effect; the results, whether positive or~     negative, will provide evidence for clinical practice and public policy regarding ADHD.~   "
100504|NCT02251730|"~     To propose a feasibility study of introducing a smoking cessation program in head and neck~     cancer patients with planned radiotherapy. The study will feature the feasibility, safety,~     and efficacy of a prospective smoking cessation program during head and neck irradiation.~   "
100505|NCT02251717|"~     This study will evaluate the safety, tolerability, and antiviral efficacy of~     ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) for 12 or 24 weeks in adults~     with chronic genotype 1 or genotype 4 hepatitis C virus (HCV) infection who have had a kidney~     transplant.~   "
100506|NCT02251704|"~     This epidemiology study is planned to run in parallel with the EPI-MAL-002 and EPI-MAL-003~     studies, enrolling from the same HDSS (health and demographic surveillance system) (or~     equivalent system) populations. The primary objectives are to produce longitudinal estimates~     of parasite prevalence in humans, and record malaria control measure usage in areas where~     EPI-MAL-002 and EPI-MAL-003 studies will take place.~   "
100507|NCT02251691|"~     The main objective of this study was to compare the drug compliance in patients after renal~     transplantation under once or twice-daily tacrolimus-based immunosuppressive regimen.~      The rationale for this study is to access the influence of once-daily prolonged-release~     tacrolimus versus standard twice-daily tacrolimus on drug compliance in renal transplantation~     recipients base on the assumption that once-daily dosing regimen may help to improve drug~     compliance.~   "
100508|NCT02251678|"~     Elorac, Inc. is evaluating the effect of Elimune™ capsules on biomarkers C-reactive protein~     (CRP), Tumor Necrosis Factor (αTNF), Interleuken-2 (IL-2), Interleuken-6 (IL-6),~     Interleuken-12 (IL-12) in subjects with plaque psoriasis with or without arthritis.~      Psoriasis is a chronic inflammatory skin disease with polygenic predisposition combined with~     triggering factors such as trauma, inflammation or medication.~      Elimune™ is a uniquely formulated prescription dietary supplement for oral administration.~     Each capsule contains a proprietary blend of natural ingredients, Vitamin D3, Folic Acid,~     Nicotinamide, Eicosapentaenoic Acid, Doscosahexaenoic Acid, Quercetin, Curcumin,~     Glycyrrhizin, and Hesperetin, which share anti-inflammatory activities including the ability~     to inhibit tumor necrosis factor-α (TNF-α).~   "
100509|NCT02251665|"~     A single-center registry of patients with acute ischemic stroke, intracerebral hemorrhage,~     and transient ischemic attack (TIA) who are emergently managed in the stroke care unit in the~     National Cerebral and Cardiovascular Center (NCVC) to determine change in underlying~     characteristics, stroke features and severity, process for diagnosis and acute treatment, and~     long-term outcomes of stroke/TIA patients over the years.~   "
100510|NCT02251652|"~     Sequential therapy with cryosurgery and ingenol mebutate may optimize the treatment of~     hypertrophic AKs and also treat non-hypertrophic AKs in this anatomic location. Furthermore,~     use of ingenol mebutate will also be evaluated for potential treatment of subclinical~     lesions.~   "
100511|NCT02251639|"~     The goal of this clinical study is to find out if certain instruments/devices, such as wide~     field fluorescence imaging point spectroscopy and/or brush cytology, can help health care~     providers find mouth cancer more quickly than a standard oral clinical exam.~   "
100512|NCT02251626|"~     To test the hypotheses that plasma and intracellular coenzyme Q10 levels will decline after~     burn injury and that ubiquinol supplementation will increase plasma and intracellular~     coenzyme Q10 levels in burn patients.~      To test the hypothesis that ubiquinol supplementation ameliorates mitochondrial~     dysfunction/disintegrity and metabolic derangements, and decreases circulating alarmins~     (a.k.a. endogenous DAMPs) in burn patients as compared with placebo.~   "
100513|NCT02251613|"~     The purpose of this study is to evaluate the effectiveness and safety of Olopatadine~     Hydrochloride (HCl) ophthalmic solution 0.1% versus Epinastine HCl ophthalmic solution, 0.05%~     in a population of healthy, adult Japanese patients (20 years of age or older) with a history~     of allergic conjunctivitis to Japanese Cedar Pollen. Patients will be randomly assigned to~     receive Olopatadine HCl ophthalmic solution, 0.1% in one eye and Epinastine HCl ophthalmic~     solution, 0.05% in the fellow eye, after which a conjunctival allergy challenge (CAC) with~     Japanese cedar pollen will be performed.~   "
100514|NCT02251600|"~     Study to characterize the single-state and steady-state dosing of oral deflazacort in~     pediatric and adolescents subjects.~   "
100515|NCT02251587|"~     The purpose of this study is to learn if a weight loss program especially designed to address~     food insecurity is more effective compared to a standard weight loss program.~   "
100516|NCT02251574|"~     The purpose of this study is to test the effectiveness of two different weight loss diets on~     obstructive sleep apnea (OSA) severity.~   "
100517|NCT02251561|"~     The purpose of this study is to compare an investigational contact lens care product (FID~     109182) to a commercially available contact lens product (Opti-Free Plus®) for corneal~     staining when used with Acuvue® Oasys® contact lenses. The contact lenses will be pre-soaked~     in the products for 24-48 hours prior to a 2-hour contralateral wear period.~   "
100518|NCT02251548|"~     This research study is evaluating a new drug called ibrutinib in combination with the~     standard drugs fludarabine, cyclophosphamide, and rituximab (FCR) as a possible treatment for~     Chronic Lymphocytic Leukemia (CLL).~   "
100519|NCT02251535|"~     Retrospective non-randomized in-vivo comparison of different levels of femoral rollback in~     the ATTUNE total knee arthroplasiy system (rotating platform CR high level roll back vs.~     rotating platform CR low level roll back) on the basis of fluoroscopic and marker-based~     motion capture evaluation. How do different levels of intra-operatively observed femoral~     rollback correlate to postoperative kinematics under weight bearing conditions? Does the~     modified design of the Attune Knee System influence the extent of the femoral rollback~     compared to the PFC Sigma Knee System? Does the femoral rollback maintain over a period of 12~     months follow up or is it reduced by, for example, remodelling of the posterior cruciate~     ligament?~   "
100520|NCT02251522|"~     It has been noted that patients dramatically overestimate their functional ability early~     after surgery. Despite use of assistive devices increasing and functional testing scores~     decreasing post-surgery, the patient reported outcome scores fail to show worsening. Outcome~     questionnaires will be administered and functional testing will be conducted on all patients~     to capture these changes.~   "
100521|NCT02251509|"~     This study will evaluate the efficacy of metoprolol tartrate compared to carvedilol on heart~     rate control in patients with atrial fibrillation and a rapid ventricular rate.~   "
100531|NCT02251379|"~     This study evaluates the effects of adding on an environmental home intervention to standard~     asthma medication management on controller medication requirements among children and~     adolescents with asthma. The investigators hypothesize that the addition of an~     individually-tailored, multi-faceted Environmental Control Strategy (ECS) to guidelines-based~     controller medication will result in less controller medication requirement and allergic~     inflammation than controller medication alone among urban asthmatic children.~   "
100567|NCT02250911|"~     The purpose of this study is to gather information on how easy it is to implement the~     workshop, as well as whether individuals find this workshop helpful. In this study,~     participants will be assigned at random to one of the two study groups. Based on the~     information we obtain, we hope to develop an easily accessible support service for~     caregivers.~   "
107497|NCT02160340|"~     The purpose of this study is to evaluate the prevalence of vitreomacular adhesion (VMA) in~     patients 40 years and older using Spectral Domain Optical Coherence Tomography.~   "
100522|NCT02251496|"~     At least one fifth of patients in European hospitals are malnourished. Malnutrition is~     associated with negative consequences, including higher rates of complications, longer~     hospital stay, impaired wound healing and increased mortality with consequent effects on~     costs of healthcare. Evidence suggests that there may be benefits to some malnourished~     patients from receiving oral nutrition supplements in the short-term but it is not known~     whether these benefits can be sustained and indeed whether similar benefits may be achieved~     using food-based interventions of lower cost. The overall objective of the study is to~     compare two nutritional interventions among malnourished patients with COPD (n=200); oral~     nutrition supplement (ONS) vs. energy and protein dense in-between meals snack during~     hospitalisation and at home. Subjects will be followed for one year. The primary endpoint is~     weight change. Secondary endpoints include forced expiratory volume in one second, forced~     vital capacity, six-minute walk distance, hand-grip strength, health related quality of life,~     length of hospital stay, energy- and protein intake, readmissions to the hospital and acute~     exacerbation. No studies are available comparing the supply of ONS to malnourished patients~     with COPD compared with the provision of regular food (in-between meals snacks). The results~     of the study will provide important information that might improve nutrition care in the~     hospital setting as well as after discharge from the hospital~   "
100523|NCT02251483|"~     The primary objective of this study is to determine whether giving SBI as a medical food~     starting with maintenance of health in the management of chronic loose and frequent stools in~     IBS-D subjects with SIBO after successful treatment with rifaximin can lead to more prolonged~     duration of benefit and delay symptom recurrence. SBI is the main ingredient in EnteraGam™,~     an orally administered prescription medical food for the dietary management of patients with~     enteropathy or chronic loose or frequent stools, including patients with IBS-D.~   "
100524|NCT02251470|"~     BACKGROUND: Virtual gaming systems offer new possibilities for home-based exercises (HBE) in~     rehabilitation. Pilot studies with stroke patients indicate that the application of Nintendo~     Wii® (WII) is practicable and can improve balance under clinical conditions. However, larger~     trials are necessary to verify these positive effects after discharge from the hospital.~      AIM: This study aims to prepare and optimize a phase III trial which compares the effects of~     two HBE programs for stroke patients.~      METHODS: A pilot study with randomized control design and repeated measures over three-months~     will be conducted. Twenty elderly stroke patients will be randomly allocated to an~     experimental group (EG) and a control group (CG). All participants will receive an~     introduction to a HBE program by an individual mentoring over 6 weeks. During the following 6~     weeks the participants perform the HBE on their own. The EG will perform a balance exercise~     program using the WII, the CG will perform a balance exercise program without technical~     support.~      Recruiting potential, the participants' acceptance of the intervention and economic aspects~     will be examined. Additionally, basic information about sensitivity of change and potential~     effect sizes regarding the proposed instruments to measure mobility are expected.~   "
100525|NCT02251457|"~     The purpose of this study is to gather preliminary data to determine if ranolazine is a safe~     and effective treatment for the symptoms of myotonia congenital, paramyotonia congenita, and~     myotonic dystrophy type 1. The duration of the study is 5 weeks.~   "
100526|NCT02251444|"~     This study investigates effects of a multidisciplinary rehabilitation program or physical~     therapy in patients with chronic low back pain on emotion regulation and coping behaviour.~      Hypothesis: Significant differences of negative emotions pre and post treatment and between~     groups after intervention.~      Standardised questionnaires are used for investigation~   "
100527|NCT02251431|"~     Among adult individuals with type 2 diabetes mellitus and at risk for heart failure with~     impaired relaxation of the heart mildly reduced kidney filtration function (Type 4~     cardiorenal syndrome) this trial will evaluate the quantitative impact of 38 weeks of~     treatment with exenatide extended-release injections versus placebo. on a cardiac biomarker~     blood test score, cardiac fibrosis seen on magnetic resonance scanning, cardiac strain~     identified by ultrasonography and strain rate imaging, and a kidney urine biomarker score.~   "
100528|NCT02251418|"~     Introduction:~      Foot ulcers are a feared complication among diabetic patients. The ulcers can cause pain,~     discomfort and reduced quality of life. The development of foot ulcers places the patients at~     a risk of amputation. In the Danish Health Care System a substantial effort is done to~     prevent and treat diabetic foot ulcers. A constant research of how to treat these wounds is~     ongoing. The goal is to optimize wound healing and prevent amputations.~      Extracorporeal shockwave therapy (ESWT) involves the use of a device that generates~     low-energy shockwaves through a headpiece, which is placed on the skin of the patient. A~     small amount of energy will be deposited in the tissue when shockwaves are applied. This~     stimulates the cells to produce substances that generate new vessels. No side effects to ESWT~     have been shown.~      Purpose:~      The investigators want to test whether shockwave therapy can improve wound healing among~     diabetic patients with foot ulcers.~      Hypothesis:~      The investigators hypothesize that shockwave therapy accelerates ulcer healing, increases~     blood flow, reduces pain, and has no side effects.~      Method:~      Patients who are interested in participation will be included in the study and divided by~     randomization into two groups of equal size. The first group is treated with ESWT in~     combination with regular guideline treatment. The second group is set up as control group and~     will only receive regular guideline treatment. The participants are examined in different~     ways to evaluate whether ESWT helps the healing of foot ulcers. The investigators want to~     measure tissue oxygen pressure and foot sense of touch. The foot ulcers are inspected for~     infection at every consultation, and a swab sample will be collected at enrollment. The size~     of the ulcers are measured and photographed each time. The investigators will count how many~     foot ulcers that are completely healed during the test period and measure the sizes of the~     remaining foot ulcers. The patients are asked to evaluate pain related to the foot ulcer.~     Data concerning participants' co morbidities and use of analgesic drugs are obtained from the~     patient journal and by patient interview.~      Significance:~      ESWT should be considered a supplement to existing clinical guidelines in wound management if~     shown to effectively help healing of diabetic foot ulcers. Improved healing should reduce the~     heavy workload on care and treatment regarding to these wounds. Hopefully, the frequency of~     amputations among diabetic patients will decline by implementing new treatment options for~     the diabetic foot.~   "
100529|NCT02251405|"~     One source of melamine exposure in the modern life is from the use of melamine tableware.~     This study examines whether the use of stainless steel containers can decrease melamine~     exposure in the daily life. The investigators hypothesize that, compared to those without use~     of stainless steel containers, university student volunteers with use of stainless steel~     containers excrete significantly lower melamine levels in urine.~   "
100530|NCT02251392|"~     This study aims to evaluate therapeutics interventions in radiodermatitis in patients with~     breast or head and neck cancer. The data collect is going to begin after determining the~     better dose in a dose-response curve that is being conduct now in the same institution. To~     evaluate the skin reaction will be applied scale of the Radiation Therapy Oncology Group~     (RTOG) - Acute Radiation Morbidity Scoring Criteria, Common Terminology Criteria for Adverse~     Events (CTCAE) and Radiation-Induced Skin Reaction Assessment Scale (RISRAS).~   "
100532|NCT02251366|"~     Intravitreal delivery of anti-vascular endothelial growth factor (VEGF) drugs has~     revolutionized the management of neovascular age-related macular degeneration (NVAMD).~     However, the requirement for near monthly administration of therapy coupled with the growing~     number of patients needing treatment has become a universal challenge in efficient delivery~     of care for retina physicians. While many retina practices have both increased the size of~     their staffs to accommodate the growing patient population and increased efficiency with the~     aid of digital photography, patient encounter times in clinic continue to increase, often~     spanning 2-4 hours. While maintaining the highest level of patient care, a streamlined~     alternative in the evaluation of patients with NVAMD to determine whether intravitreal~     therapy with an anti-VEGF agent is indicated at a particular office visit would be desirable.~      This multi-satellite, prospective, randomized pilot study will compare standard-of-care,~     physician- based retinal evaluation, defined as retinal examination by a physician and~     standard imaging with optical coherence tomography (OCT) and optional fluorescein angiography~     (FA), versus physician-guided diagnostic evaluation, defined as standard imaging with OCT and~     optional FA without retinal examination by a physician in the management of NVAMD with~     anti-VEGF therapy. Outcomes for this study are aimed primarily at demonstrating that the~     physician-guided diagnostic approach to managing patients with NVAMD is not inferior to the~     physician-based retinal evaluation based on measures such as a change from baseline in visual~     acuity and in central subfield thickness (CSF) on OCT. Other outcomes to be assessed in this~     study are length of visit times, numbers of intravitreal injections of anti-VEGF agents~     administered, numbers of diagnostic tests performed to determine whether treatment should be~     given at each visit, and frequency of retinal examinations performed for each participating~     patient in each cohort. Perceptions of quality of vision and patient satisfaction will be~     captured by interviews with patients following each clinic visit; clinical impressions of~     physicians will be captured by a brief physician survey. Finally, the feasibility of~     recruiting patients, as measured by how many eligible patients are seen at each Wilmer~     satellite, how many patients agree to be randomized, how many patients follow-up, and the~     attrition rates at the 4 and 8-month outcome visits will be assessed.~   "
100533|NCT02251353|"~     The number of intervention performed for metastatic breast cancer has dramatically increased~     over the past 2 decades. Hepatectomy and pulmonary resection for stage IV colorectal cancer~     is now considered the standard of care for resectable patients with isolated hepatic and/or~     pulmonary disease and acceptable performance status. However, the indications for resection /~     intervention of breast cancer origin metastases are not as clearly defined. The aim of this~     study to focus on emerging data for the intervention (resection and/or radiofrequency~     ablation (RFA), transcatheter arterial chemoembolization (TACE), cyberKnife stereotactic~     radiosurgery) of breast cancer metastatic disease to the lung and liver, with a focus on~     indications for resection / intervention.~   "
100534|NCT02251340|"~     The objectives of this project are to increase families' understanding of eczema and improve~     eczema management in the primary care setting. We have created an Eczema Care Plan similar~     to those used in the management of asthma. It gives specific instructions about medications,~     bathing and moisturizing, as well as when to seek further treatment. We will conduct a~     randomized controlled trial of the plan in Primary Care at Longwood for a 10 month period.~     Specifically, we aim to (1) decrease eczema severity (2) improve patient quality of life and~     (3) increase parental knowledge and confidence about eczema management. We also plan to track~     provider uptake and documentation of the plan and elicit feedback from parents and providers~     on the utility and feasibility of the plan.~   "
100535|NCT02251327|"~     Consenting adults will be interviewed for demographic and medical information, and then will~     be asked to provide two expectorated sputum specimens. In the study laboratory, sputa will be~     tested using conventional and investigational diagnostic tests for tuberculosis.~   "
100536|NCT02251314|"~     Despite recent advances in cancer treatment, little impact has been made on curing as opposed~     to controlling cancers over the last several decades. Part of the problem is that~     investigators have an incomplete understanding of how tumours behave as they evolve and in~     response to treatment. In this trial, the investigators hope to better understand the~     evolution of BRAF melanoma in response to drugs a patient may have received such as~     vemurafenib or dabrafenib. Importantly, the investigators want to understand how the tumours~     evolve resistance to these drugs and whether this can be predicted through blood tests, in~     particular of the circulating tumour DNA.~   "
100537|NCT02251301|"~     The purpose of this study is to investigate whether combining interval training with skim~     milk supplementation will result in improved glucose control and markers of cardiovascular~     health in people with type 2 diabetes. Participants will complete supervised interval~     training three times a week over a 12 week training period while consuming skim-milk,~     whey/casein protein drink, or a placebo beverage that does not contain any calories or~     vitamins/minerals immediately and 1 hour after each training session. After twelve weeks~     participants will repeat baseline tests to examine any effects of the intervention on their~     glucose control, fitness, blood vessel function, body composition, and blood markers of~     inflammation.~   "
100538|NCT02251288|"~     A phase I prospective, randomized study in healthy adult subjects at a single center. Adult~     subjects age 18 to 47 years and meeting all enrollment criteria will choose to participate as~     subjects who receive inactivated vaccine followed by a live vaccine boost at 4 weeks (Group~     1), 12 weeks (Group 2), or 24 weeks (Group 3), or to be in an observational group (Group 4)~     which will not be scheduled for a booster dose but may serve as a roll-over group for~     subjects who withdraw prior to the second vaccination but agree to remain in follow-up. A~     fifth group will receive two intramuscular doses of adjuvanted H7N9 pIIV separated by four~     weeks.~   "
100539|NCT02251275|"~     The purpose of the study is to evaluate and describe the long term safety of tolvaptan in~     patients with autosomal dominant polycystic kidney disease (ADPKD~   "
100540|NCT02251262|"~     With aging of the general population and broadening indications, the number of pacemaker~     recipients is steadily increasing. The incidence of infections of the implanted material, a~     dreaded major complication, is also rising. The diagnosis is evident in presence of an~     abscessed pocket, cutaneous breakthrough of the pulse generator or vegetations attached to~     the lead. On the other hand, a proportion of patients present with less specific clinical~     manifestations and a pacemaker recipient may be recurrently hospitalized for an infectious~     disorder of unknown origin despite detailed investigations. Without proof of lead infection,~     removal of the system without confirmation of its infection is usually proposed, despite the~     known morbidity and mortality associated with the extraction procedure (0.5 to 2%). Positive~     culture of the leads implies that the leads were involved in the infectious process. In~     recent years, 18FDG-PET-CT scan has made promising contributions in different areas including~     imaging to detect infection at different organ sites. Absence of hyperfixation of the lead,~     identified by 18FDG-PET/CT scan may be an accurate sign of absence of pacing system~     infection.~      The extraction of intracardiac implanted material, when it is indicated by the current~     standard strategy, may result in negative bacteriological cultures in 10 to 25% of patients,~     even when they did not receive antibiotics before extraction.~      The hypothesis of the study is that a new strategy adding 18FDG-PET-CT to the current~     strategy may avoid or reduce these false-positives.~      Therefore it is hypothesized that the sensitivity of 18FDG-PET-CT will be high enough to~     avoid unnecessary extractions of uninfected leads, resulting in a high negative predictive~     value of the new diagnostic strategy incorporating 18FDG-PET-CT. The present study aims at~     providing valid estimates of diagnostic accuracy parameters of 18FDG-PET-CT, especially its~     sensitivity.~      For this clinical study, firstly, 18FDG-PET-CT exam will be performed in patients, with~     suspicion of pacing or defibrillation lead infection, hospitalized in cardiology unit;~     secondarily, an intervention for the extraction of the intra-cardiac material, under general~     anesthesia, will be practiced and then a bacteriological culture for extracted material will~     be required.~      The end of study visit is complete the last day of material extraction. The follow up will~     last 2 to 7 days.~   "
100541|NCT02251249|"~     Oral antiplatelet therapy is a key treatment of the STEMI (ST elevation myocardial~     infarction). Delayed action isn't suitable and has to be elucidated. If a delayed gastric~     emptying time is observed during STEMI, limiting the use of morphine and encourage the use of~     prokinetic agents can be a first answer to optimize coronary angioplasty environment.~      Investigators propose a study to assess the gastric emptying times at the acute phase of~     myocardial infarction using a validated paracetamol absorption test. The STEMI group will be~     compared to in one hand, itself with measures performed 72 hours±12h after the event onset;~     and on the other hand, to a stable patient group referred for angioplasty for angina or~     non-ST-segment elevation myocardial infarction (NSTEMI). For STEMI group and stable patient~     group, the delay of apparition of Prasugrel or Ticagrelor efficacy will be determined by~     VerifyNow® test and correlated to gastric emptying times.~   "
100542|NCT02251236|"~     The project will have two tracks, one for participants who are currently taking~     elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or E/C/F/tenofovir~     alafenamide (E/C/F/TDF or E/C/F/TAF) single-tablet regimen* (STR) (Track A) and one for~     participants who will begin therapy with E/C/F/TDF or E/C/F/TAF STR during the study (Track~     B).~      Participants will take E/C/F/TDF and/or E/C/F/tenofovir alafenamide fumarate (E/C/F/TAF)~     STR** (if available) for 24 weeks.~      *Co-formulation of 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and~     300 mg of tenofovir disoproxil fumarate.~      **Co-formulation of 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine,~     and 10 mg of tenofovir alafenamide fumarate.~   "
100543|NCT02251223|"~     Primary: Sequentially determine the effects of three dose combinations of tipranavir (TPV) /~     ritonavir (RTV) (administered b.i.d.), TPV 1250 mg/RTV 100 mg vs. TPV 750 mg/RTV 100 mg vs.~     TPV 250 mg/RTV 200 mg on the steady-state pharmacokinetics of zidovudine, lamivudine,~     stavudine, didanosine, abacavir, nevirapine and efavirenz at approved doses. The three~     treatment groups will be enrolled sequentially starting with the highest tipranavir dosage~     group first and ending with the lowest tipranavir dosage group.~      Secondary: A) To assess the effects of zidovudine, lamivudine, stavudine, didanosine,~     abacavir, nevirapine, and efavirenz on the pharmacokinetics of tipranavir/ritonavir compared~     to historical controls.~      B) To assess the safety of three tipranavir/ritonavir combinations when used in combination~     with protocol defined antiretrovirals.~   "
100544|NCT02251210|"~     To investigate efficacy and safety of 3 doses of BIIL 284 BS in active rheumatoid arthritis~     (RA) and determine the dose with most positive efficacy / safety ratio. Pharmacokinetic~     profile will be also obtained.~   "
100545|NCT02251197|"~     The objective of this study is to assess the safety, tolerability and pharmacokinetic~     characteristics of BIII 890 after intravenous infusion in acute ischemic stroke patients.~   "
100546|NCT02251184|"~     Comparison of pharmacokinetics of dipyridamole administered as Aggrenox versus dipyridamole~     administered as the immediate release formulation plus aspirin, under conditions of reduced~     stomach acidity.~   "
100547|NCT02251171|"~     Study to determine the effects of steady-state Tipranavir (TPV) / Ritonavir (RTV)~     (500mg/200mg bid) on the single-dose pharmacokinetics of Rifabutin (RFB) and to determine the~     effects of single-dose RFB on the steady-state pharmacokinetics of TPV 500mg (co-administered~     with RTV 200mg)~   "
100548|NCT02251158|"~     Study to determine the relative bioavailability of 500/200 mg of tipranavir/ritonavir (TPV/r)~     oral solution compared to 500/200 mg of TPV/r capsules following oral administration and to~     investigate the relative bioavailability of 500/200 mg of TPV/r oral solution with food~     versus without food.~   "
100549|NCT02251145|"~     Study to characterise the effects of two dose combinations of tipranavir/ritonavir (TPV 500~     mg/RTV 100 mg and TPV 750 mg/RTV 200 mg) administered BID, on the pharmacokinetics of~     tenofovir disoproxil fumarate as well as the effects of tenofovir disoproxil fumarate on the~     pharmacokinetics of tipranavir/ritonavir.~   "
100550|NCT02251132|"~     The objective of this study is to establish the tipranavir-ritonavir steady-state~     dose-exposure relationships when administered on a b.i.d. dosing regimen; to determine the~     effects of tipranavir (TPV) and ritonavir (RTV) on cytochrome P-450 (CYP3A4) activity; to~     establish the dependency of the TPV M1 metabolite on RTV co-administration. Additionally, the~     short-term safety and tolerance of this drug combination will be evaluated.~   "
100551|NCT02251119|"~     The objective of the study was to determine if the co-administration of loperamide (LOP) with~     tipranavir (TPV), ritonavir (RTV), or TPV plus RTV (TPV/r) caused a clinically significant~     change in the respiratory response to carbon dioxide (CO2), defined as a 10% decrease in the~     area under the pharmacodynamic effect/time curve or at least a 25% decrease in at least one~     pharmacodynamic time point.~   "
100552|NCT02251106|"~     A recent province-wide survey (Alberta, Canada) suggests that clinicians' beliefs about soft~     lumbar bracing for low back pain (LBP) vary substantially. Approximately 50% of clinicians~     (MDs, DCs, PTs) find back braces useful for acute back pain while the remaining half report~     that bracing causes muscle atrophy. While previous studies suggest bracing for acute low back~     conditions can reduce pain and does not cause atrophy, no prior study has assessed back~     function after bracing using self-reported and objective measures within the same cohort.~      PURPOSE:~      To assess both self-reported and objective measures of spine function before, and after, use~     of an inelastic lumbar brace over a two week period.~      STUDY DESIGN:~      Before-After Design~      OUTCOME MEASURES:~      Self-reported spine function, spinal stiffness and muscle endurance.~      METHODS:~      Three groups were studied: asymptomatics who did not wear a brace (-LBP/-Brace),~     asymptomatics who were braced (-LBP/+Brace) and acute LBP subjects who were braced~     (+LBP/+Brace). Both groups of braced subjects (-LBP/+Brace; +LBP/+Brace) were instructed to~     wear the brace continually for 2 weeks with the exception of bedroom & bathroom activities.~     Before and after the 2 week period, 3 measures of spine function were performed: spinal~     stiffness via motorized indentation of the L3 spinous process, a modified Sorensen test~     (timed lumbar extension against gravity), and the Oswestry Disability Index (ODI). Unbraced~     (-LBP/-Brace) subjects were studied over the same time with the same measures. Repeated~     measures analyses of variance were conducted for all three outcomes with a significance level~     of 0.05.~   "
100568|NCT02250898|"~     The aims of this study are to determine the effectiveness of myofascial massage specific to~     the breast/chest/shoulder area in reducing self-reported pain and increasing mobility among~     patients who have undergone a mastectomy or other breast surgery compared to a control group~     receiving global relaxation massages.~   "
100553|NCT02251093|"~     The trial medicinal product (Lcr Regenerans®) is obtained from the culture of a strain of~     Lactobacillus rhamnosus Lcr35®. By virtue of the freeze-drying technique, Lactobacillus~     rhamnosus Lcr35® is a live bacterium administered with its culture medium.~      It should be noted that Lcr Regenerans® is already marketed as a medical device (EC marking:~     0499). It helps to regenerate the vaginal flora thanks to its physical and chemical effects~     (lowering the vaginal pH).~      A number of in vitro and in vivo studies have demonstrated the ability of Lactobacillus~     rhamnosus Lcr35®:~        -  to establish itself in the vaginal epithelium, along with the durability of this~          establishment.~        -  and to inhibit the growth of pathogenic organisms responsible for causing bacterial~          vaginosis (Gardnerella vaginalis and Prevotella bivia) but also for mycoses (Candida~          albicans), by synthesising various microbicidal substances.~      This research follows on from the Candiflore observational study in which 514 patients were~     monitored and which demonstrated a clearly positive result in favour of the use of vaginal~     Lcr Regenerans® for preventing recurrences of VVC.~      The purpose of this new research is thus to demonstrate the efficacy of Lcr Regenerans®, in~     the prevention of vulvovaginal candidiasis recurrences in patients with a history of VVC with~     recurrent episodes, in view of obtaining a marketing authorisation.~   "
100554|NCT02251080|"~     Attention Deficit/Hyperactivity Disorder (ADHD) is a common condition in young adults. There~     are many safe oral therapies that require daily use to be effective. Because frequent~     follow-up visits have been shown to increase adherence to medication, we will determine if~     adherence to oral therapy for ADHD will improve with an intervention involving weekly~     internet-based contact without an office visit.~      The primary aim is to determine the effectiveness of an Internet-based survey in improving~     adherence to therapy for ADHD. Subjects in this study will be either receive a weekly~     Internet-based survey assessing the prescribed medication and their ADHD, or to receive~     standard-of-care therapy in which they will take their medication. The following hypothesis~     is to be tested: A weekly Internet survey will promote improved adherence to oral ADHD~     medications.~   "
100555|NCT02251067|"~     The purpose of this study is to determine whether VPI-2690B Injection is effective in the~     treatment of diabetic nephropathy.~   "
100556|NCT02251054|"~     This study compares the efficacy of embedding avatars into an online self-management program~     that teaches OAB behavioral therapy on OAB-related quality of life, symptoms, self-efficacy,~     and adherence versus the same program without avatars~   "
100557|NCT02251041|"~     The purpose of this study is to establish the effectiveness of the combined drug approach~     (anti-thrombin III, infliximab, apotransferrin, human recombinant erythropoietin beta,~     C1-inhibitor, glutathione, alfa-tocopherol, melatonin and epoprostenol)aimed to reduce~     ischemia-reperfusion injury during liver transplantation in eligible recipients.~   "
100558|NCT02251028|"~     The purpose of this study is to determine whether a specifically tailored value-based~     cognitive behavioural therapy program (V-CBT) is able to prevent the development of~     persistent disability, pain, and psychological distress if delivered within the first three~     months after a whiplash injury.~   "
100559|NCT02251015|"~     To investigate the effects of the use of occlusal splint over postural balance in individuals~     with signs and symptoms of temporomandibular disorder. The research group consists of 49~     patients (36 getting occlusal splints and 13 as control group) between 18 and 75 years old,~     both genders, diagnosed as temporomandibular disorder (TMD) by RDC/TMD questionnaire and~     magnetic resonance imaging of the temporomandibular joints. The research is a randomized,~     controlled, prospective clinical study with intervention. Postural equilibrium will be~     evaluated by means of a force plate. In the randomization, the splinted group was under an~     occlusal-stability criterion as well as advised under therapeutic exercises while the control~     group got only orientation about therapeutic exercises. After 12 weeks, the groups were~     re-evaluated. The results will be analyzed by categorical data using absolute and relative~     frequencies as well as continuous data using average, median, standard deviation, 25 and 75~     percentiles, besides minimum and maximum values; comparison between the times by~     non-parametric Wilcoxon, Mann-Whitney and ANOVA tests with a threshold of significance of~     0.05.~   "
100560|NCT02251002|"~     The purpose of this study is to determine whether there is a quantitative relationship~     between brain processes seen by a MRI and visual deficits caused by mild to moderate~     traumatic brain injuries (mTBI).~   "
100561|NCT02250989|"~     The objective of this study is to investigative the influence of different levels of~     glycaemia or insulinemia in vascular endothelium in ischemia/reperfusion lesion after~     myocardial infarction~   "
100562|NCT02250976|"~     To develop combination product of micronized fenofibrate plus pitavastatin, we would like to~     evaluate the comparative pharmacokinetics and safety of fixed-dose combination(micronized~     fenofibrate160mg+pitavastatin Ca 2mg) versus coadministration of Lipilfen~     cap.160mg(micronized fenofibrate160mg) and Livaro tab. 2mg(pitavastatin Ca 2mg) under fed~     condition in healthy male volunteers.~   "
100563|NCT02250963|"~     This study aimed to compare dobutamine stress echocardiography (DES) with computed tomography~     coronary angiography (CTCA) in patients with undergoing intermediate to high risk noncardiac~     surgery.~   "
100564|NCT02250950|"~     The current study involves conducting an intervention based on self-determination theory~     (SDT) and motivational interviewing (MI) to promote physical activity in a racially-diverse~     sample. It is expected that this intervention will successfully increase physical activity in~     participants.~   "
100565|NCT02250937|"~     Any time the words you, your, I, or me appear, it is meant to apply to the potential~     participant.~      The goal of this clinical research study is to compare how well two different schedules of~     giving busulfan with fludarabine and cladribine before a stem cell transplant in patients~     with AML or MDS may help to control the disease. The safety of this drug combination will~     also be studied.~      This is an investigational study. Busulfan, fludarabine, and cladribine are FDA approved and~     commercially available. It is investigational to give cladribine in combination with busulfan~     and fludarabine with a stem cell transplant.~      Up to 116 patients will take part in this study. All will be enrolled at MD Anderson.~   "
100569|NCT02250885|"~     Evaluate the efficacy of Selinexor in patients with poorly differentiated lung and~     gastrointestinal and pancreatic neuroendocrine tumors.~   "
107963|NCT02154269|"~     The purpose of this study is to evaluate the effectiveness of treatment with G-CSF in~     patients with chronic heart failure secondary to Chagas disease.~   "
100570|NCT02250872|"~     Cisplatin is a potent chemotherapeutic agent, however, its nephrotoxicity manifested by acute~     kidney injury (AKI) often limits applicability. Dipeptidylpeptidase-4 (DPP4) inhibitors are~     well known to improve glucose intolerance by augmentation of endogenous glucagon like peptide~     (GLP-1) and glucose-dependent insulinotropic peptide (GIP). DPP4 inhibitor also has the~     potential anti-apoptotic and renoprotective effect in a mouse model of cisplatin-induced AKI.~     This is a single-center, randomized, double-blind, parallel-group, placebo-controlled,~     prospective study to investigate the renoprotective effect of DPP4 inhibitor on~     cisplatin-induced AKI. A total 182 patients, who are scheduled to treat with cisplatin, will~     be recruited and randomly assigned to either Gemigliptin or placebo groups. Subjects will~     take study drugs for 8 days starting from one day before cisplatin treatment. Serum~     creatinine (Cr) and estimated glomerular filtration rate (eGFR) will be measured at 7 days~     after cisplatin treatment.~   "
100571|NCT02250859|"~     The purpose of this study is to assess the pharmakokinetic profile of Minocycline in FMX-101~     4% foam product in male and female some of which are with acne~   "
100572|NCT02250846|"~     The purpose of this study is to determine whether EGFR-TKI can control the development of~     intracranial lesions in Non Small Cell Lung Cancer patients with asymptomatic brain~     metastases, and the difference in progression free survival between exon 19 and exon 21~     mutations.~   "
100573|NCT02250833|"~     A randomized, open-label, single-dose, two-period, two-way, crossover study to compare the~     pharmacokinetics and safety CKD-828 (Fixed Dose Combination Tablet) to coadministration~     telmisartan and s-amlodipine in health volunteers.~   "
100574|NCT02250820|"~     The study will examine the quality of two sedation techniques (dexmedetomidine and~     pentobarbital) used for children aged 3 to 24 months who are undergoing a transthoracic~     echocardiography (TTE).~   "
100575|NCT02250807|"~     The purpose of this study is to show superiority of simeprevir (SMV) in combination with~     sofosbuvir for 12 weeks versus a historical control. Historical control will be a composite~     of the observed historical sustained virological response at Week 12 (SVR12) rates of SMV in~     combination with (pegylated) interferon (PegIFN)/ribavirin (RBV) of the subpopulations in~     study HPC3011 (NCT01567735) and will depend on the percentage of treatment-naive, prior~     relapser, prior non-responder, interferon (IFN)-intolerant and other subjects enrolled in~     this study.~   "
100576|NCT02250794|"~     The purpose of this study is to test whether a combination of two pills commonly used to~     treat outpatient diabetes called metformin and sitagliptin (januvia) could provide successful~     control of blood sugar levels in patients with type 2 diabetes during hospitalization for the~     treatment of a general medical condition. Both metformin and sitagliptin are currently~     approved by the Food and Drug Administration for the treatment of type 2 diabetes, but little~     experience exists for their use in hospitalized patients. The current standard practice is to~     use insulin injections to control blood sugar in hospitalized patients with type 2 diabetes.~     This study will compare the use of metformin tablets twice per day along with sitagliptin~     tablets once per day with daily insulin injections in patients with type 2 diabetes during~     hospitalization, and will study how well the blood sugar levels are controlled.~   "
100577|NCT02250781|"~     This phase I trial studies the side effects and best dose of Oral ONC201 in treating patients~     with advanced solid tumors. Oral ONC201 may stop the growth of tumor cells by blocking some~     of the enzymes needed for cell growth.~   "
100578|NCT02250768|"~     The purpose of this study was to investigate the potential effects of Granulocyte-Macrophage~     Stimulating-Colony Factor (GM-CSF) supplementation in embryo culture for patients with~     repeated implantation failure (RIF)~   "
100579|NCT02250755|"~     This study therefore aims to assess current treatment recommended by scientific societies [~     6-13 ] , brain MRI with injection of contrast for the diagnosis and monitoring of brain~     metastases . The recommended dose of this examination gadolinium is from 0.1 to 0.3 mmol / kg~     [ 14 ] . Sequences infusion different from one center to the other made : some use the~     infusion T1, other infusion T2 * . No recommendation establishes whether it is preferable to~     use one or the other of these sequences.~      No examination is added for the purposes of protocol. Indications for MRI and the number and~     timing of MRI checks under this protocol are consistent with what is done in practice . The~     used type of gadolinium and the injected dose will be identical for both sequences infusion .~     The assessment shall not in any case the contrast but the interpretation of the sequence~     itself. Special procedures monitoring implemented embodiment correspond to the two sequences~     instead of infusion (one of T1-weighted and T2 * in the other ) , in the original MRI and MRI~     of the first control , in order to compare their effectiveness~   "
100580|NCT02250742|"~     The study will establish data on the function of trunk muscles in healthy and low back pain~     patient's pre and post dry needling treatment. This will help in understanding the underlying~     mechanism of this treatment and reveal the effect of dry needling on muscle performance.~      Study hypothesis is that an improvement of back muscle function following dry needling~     procedure will be found.~   "
100581|NCT02250729|"~     The main objective of this study is to compare pholcodine exposure in patients having~     presented with a perianaesthetic anaphylactic reaction to a NMBA (cases) to pholcodine~     exposure in matched anaesthetised patients with injection of NMBA, who did not present with~     an anaphylactic reaction (controls).~      The secondary objectives of the study are:~        -  To compare anti-pholcodine IgE, anti-ammonium IV IgE and total IgE levels between the~          case and control groups.~        -  To study the concordance between exposure to pholcodine in cases and controls, by means~          of a patient self-questionnaire on the one hand and, on the other hand, by a~          computerized drug history, supplemented where relevant by the drug master file.~        -  To study the impact of taking 1, 2 or 3 sources in account for pholcodine exposition.~        -  To study the association between exposure to pholcodine and the presence/levels of~          pholcodine-specific IgE, reflecting sensitisation to pholcodine.~        -  To study NMBA and pholcodine cross-sensitisation by testing skin reactions to pholcodine~          in case patients allergic to (at least) one NMBA.~   "
100634|NCT02250040|"~     The purpose of this study was to identify and evaluate the effect of a new protocol of~     physiotherapy to retrain walking ability after stroke in subjects older than fifty-five. This~     protocol was composed of specific, clearly defined and reproducible techniques, based on~     clinical and functional criteria.~   "
100582|NCT02250716|"~     Based on the high incidence of cervical cancer and high grade dysplasia and increased~     progression and incomplete treatment of CIN2 and 3 in South Africa, we propose to study the~     effect of cryotherapy among HIV-positive women diagnosed with CIN 1 versus regular 12 month~     cytology follow-up. This study will be a dual-arm, open-label, randomized clinical trial for~     HIV-infected women diagnosed with CIN 1 and receiving care at the Themba Lethu Clinic, Helen~     Joseph Hospital, Johannesburg, South Africa. CIN 1 will be identified from patients who have~     had a colposcopic biopsy for persistent LSIL as per standard of care.~   "
100583|NCT02250703|"~     BACKGROUND INFORMATION AND RATIONALE~      Pediatric patients scheduled for dental procedures under general anesthesia can have~     significant anxiety before the procedure. They are commonly pre medicated to minimize~     distress and to facilitate a smooth induction of anesthesia. Oral Midazolam at 0.5mg/kg dose~     is more widely used for this purpose . However the commonly used maximum dose is up to 15mg.~     It also has many limitations such as paradoxical reaction, increased incidence of emergence~     delirium and negative postoperative behavior changes . Intranasal dexmedetomidine has been~     used an effective and safe alternative premedication to oral midazolam in children. At a dose~     of 2micrograms/kg, intranasal dexmedetomidine as premedication resulted in excellent sedation~     in children aged 5-8yrs with no adverse hemodynamic effects. It has other advantages such as~     providing analgesia and facilitating smooth emergence from anesthesia.~      The goal of this study is to find out if intranasal dexmedetomidine is a superior alternative~     as premedication to oral midazolam in children weighing more than 20kg undergoing general~     anesthesia for dental rehabilitation.~   "
100584|NCT02250690|"~     The aims of the present study was to analyze the effect of consecutive sessions of~     Transcranial direct current stimulation associated to kinesiotherapy about gait performance~     of Parkinson' s disease. For this, the primary outcome was evaluation of gait performance by~     means of space and temporal parameters as speed (meter/second ), stride frequency (steps/min)~     and stride length (m). The secondary outcome is motor cortex excitability which is analyzed~     by means of single pulse transcranial magnetic stimulation (TMS) intends to determine: motor~     evoked potential amplitude (MEP) and rest motor threshold (rMT).~   "
100585|NCT02250677|"~     Background Statins are cholesterol lowering drugs that are prescribed to lower the risk of~     cardio-vascular diseases (CVD). The use of statins has increased markedly and it is now one~     of the most prescribed drugs in the world. 600,000 people in Denmark are taking statins on a~     daily basis, 40 % of these are taking the medication without having any other risk factors~     for CVD than elevated blood-cholesterol i.e. they are in primary prevention.~      Statins are not without side effects and studies have shown that there is an elevated risk of~     developing diabetes when taking statins. This has led to an increased debate about the use of~     statins in primary prevention. Furthermore a large meta-analysis has shown that to prevent~     one event of CVD, it is necessary to treat 200 people for 3-5 years. These data suggest that~     more conservative use of statins to prevent CVD in otherwise healthy individuals at low risk~     for future CVD may be warranted.~      Other side effects of statins are muscle myalgia, muscle cramps and fatigue which potentially~     can prevent a physically active lifestyle. The biomedical background of these side effects is~     not fully elucidated but it has been shown that there is a link to decreasing levels of an~     important enzyme, Q10, which plays a role in muscle energy metabolism.~      Hypothesis~      The overarching research question is: why does statin treatment cause muscle pain? Does~     statin treatment impair (or even prohibit) physical exercise training? Furthermore we would~     like to answer the following questions:~      a Does statin treatment impair (or even prohibit) physical exercise training?~      b Does statin treatment cause:~        -  Decreased muscle strength?~        -  Skeletal muscle inflammation?~        -  Decreased mitochondrial respiratory function?~      c Abnormal glucose homeostasis?~   "
100586|NCT02250664|"~     This study will examine extended exposure to cigarettes varying in nicotine content among~     opioid abusers. Prevalence of smoking among opioid-dependent adults far exceeds that of the~     general US adult population. Opioid-dependent smokers are also at elevated risk for~     smoking-related adverse health effects. Studies testing an innovative regulatory strategy of~     reducing the nicotine content of cigarettes to a non-addictive level have shown promising~     beneficial effects (decreased smoking rate, reduced toxicant exposure, and increased~     cessation) in the general population of smokers. However, these studies have uniformly~     excluded vulnerable populations like opioid abusers who may respond differently considering~     their greater vulnerability to smoking and nicotine dependence. Thus, little is known~     scientifically about how this highly vulnerable subgroup of smokers might respond to a~     nicotine reduction policy. This project is designed to address that substantial knowledge~     gap.~   "
100587|NCT02250651|"~     This study will evaluate the efficacy and safety of bimatoprost sustained-release (SR) in~     patients with open-angle glaucoma or ocular hypertension. The study includes a 12-month~     treatment period with an 8-month extended follow-up.~   "
100588|NCT02250638|"~     To obtain sufficient specimens and correlating clinical data from a well-controlled~     prospective clinical trial collecting longitudinal specimens from subjects diagnosed with any~     stage of pancreatic cancer.~   "
100589|NCT02250625|"~     To obtain sufficient specimens and correlating clinical data from a well-controlled~     prospective clinical trial collecting specimens from healthy subjects t on vitamin D assays,~     and to establish a collection of specimens that will support future assay discovery and~     validation efforts.~   "
100590|NCT02250612|"~     The purpose of this double-masked, randomized, controlled study is to assess the safety and~     ocular hypotensive efficacy of four different doses of SYL040012 (bamosiran) eye drops~     compared to Timolol maleate 0.5% after 28 treatment days in patients with elevated~     intraocular pressure.~   "
100591|NCT02250599|"~     The present study will be a randomized, control, multicenter phase II study of metastatic~     nasopharyngeal carcinoma (NPC) treated with evacizumab (AVASTIN,Roch) with paclitaxel and~     carboplatin regimen (TC+AVASTIN) or carboplatin/paclitaxel alone (TC). The population~     consists of metastatic nasopharyngeal carcinoma (NPC) that failed the radical radiotherapy or~     chemotherapy-naïve advanced NPC (stage IV). The effectiveness and side effects will be~     evaluated according to RECIST 1.1 and NCI-CTC AE V4.0.TEORTC QLQ-C30 and EORTC QLQ-H&N35 are~     used to measure PRO outcome for this study.~   "
100651|NCT02249819|"~     The purpose of this study is to determine if non-invasive brain stimulation (transcranial~     direct current stimulation) delivered prior to language therapy will improve word-finding in~     individuals with aphasia who are 6 months or greater post-stroke.~   "
100592|NCT02250586|"~     BACKGROUND: About 2.3 % of the adult population in Sweden is considered to be problem~     gamblers, and it is estimated that only 5 % of them seek treatment. Problem gambling can have~     devastating effects on the economy, health and relationship, both for the problem gambler and~     their concerned significant other (CSO). No empirically supported program exists for the CSOs~     of problem gamblers. Consequently, the aim of this study is to develop and evaluate a program~     aimed at CSOs of treatment refusing problem gamblers. The program will be based on principles~     from cognitive behavioral therapy and motivational interviewing. In order to benefit as many~     CSOs as possible, the program will be delivered via the Internet with therapist support via~     email and telephone.~      METHODS/DESIGN: This will be a randomized wait-list controlled internet-delivered trial. A~     cognitive behavioral-therapy program for the concerned significant others (CSOs) of problem~     gamblers (PGs) will be developed and evaluated. The participants will work through 8 modules~     over 10 weeks in a secure online environment, and receive support via text messages and over~     telephone. 150 CSOs over 18 years of age will be included. Measures will be taken at baseline~     3, 6 and 12 months. Primary outcomes concern gambling-related harm and motivating the PG to~     seek treatment. Secondary outcomes are CSO's feelings of depression, anxiety, relationship~     satisfaction and quality of life.~      HYPOTHESIS: The investigators hypothesize: 1) that the CBT-CSO group will lead to a reduction~     in gambling related harm experienced by the CSO, 2) the CBT-CSO program will reduce the CSO's~     anxiety and depressive feelings, 3) the CBT-CSO program will decrease the amount of time and~     money the problem gambler spend on gambling, 4) the CBT-CSO program will increase the CSO's~     relationship satisfaction with the problem gambler.~   "
100593|NCT02250573|"~     The main objectives of this study were to investigate the safety and efficacy of~     Replenine®-VF administered in appropriate dosage by bolus infusion to prevent bleeding and~     achieve haemostasis in subjects with haemophilia B undergoing surgery.~   "
100594|NCT02250560|"~     The main objective of the study is to investigate the safety and efficacy of Replenine®-VF~     administered by continuous infusion in appropriate dosage to prevent bleeding and achieve~     haemostasis in patients with haemophilia B undergoing major surgery.~   "
100595|NCT02250547|"~     Evaluate the percentage of patients optimized at least once every month by the SonR automatic~     optimization method, until M6 follow-up, in Heart failure (HF) patients prevalently in sinus~     rhythm~   "
100596|NCT02250534|"~     This study will examine extended exposure to cigarettes varying in nicotine content among~     disadvantaged women. Disadvantaged women are at increased risk for smoking, nicotine~     dependence, and using high nicotine yield cigarettes and are also at significantly increased~     risk for smoking-related adverse health consequences, including cervical cancer, thrombosis~     related to hormone-based contraception, infertility, and early menopause. Studies testing an~     innovative regulatory strategy of reducing the nicotine content of cigarettes to a~     non-addictive level have shown promising beneficial effects (decreased smoking rate, reduced~     toxicant exposure, and increased cessation) in the general population of smokers. However,~     these studies have uniformly excluded vulnerable populations like disadvantaged worn who may~     respond differently considering their greater vulnerability to smoking and nicotine~     dependence. Thus, little is known scientifically about how this highly vulnerable subgroup of~     smokers might respond to a nicotine reduction policy. This project is designed to address~     that substantial knowledge gap.~   "
100597|NCT02250521|"~     Our primary aim for the study is to measure intubation success rate on first attempt in~     management of the difficult airway, which could possibly allow us to determine at what direct~     laryngoscopic grade it becomes advantageous to use the McGRATH® MAC video laryngoscope.~   "
100598|NCT02250508|"~     The main objectives of the study were~        -  to compare the pharmacokinetics (PK) of Optivate® and Haemate P® in various types of~          vonWillebrand disease (VWD) using the results from the VWF: RCo, VWF:Ag, VWF:CBA and~          Factor VIII assays.~        -  to compare the clinical tolerance and safety of these two treatments after single IV~          infusions in subjects with VWD.~   "
100599|NCT02250495|"~     The purpose of the VIBE study is to evaluate the efficacy and safety of the Sympara~     Therapeutic System in the treatment of hypertension~   "
100600|NCT02250482|"~     The main objective of the study is to investigate the safety and efficacy of Optivate®,~     administered in appropriate dosage to present bleeding and achieve haemostasis in patients~     with Haemophilia A undergoing surgery.~   "
100601|NCT02250469|"~     12-SMI-2014 is a post-market, randomised, pilot study to identify and rate differences in~     patient experiences with two different types of Spinal Cord Stimulator devices which are~     routinely used to treat chronic pain.~   "
100602|NCT02250456|"~     Turner syndrome is a genetic condition, rare, due to the total or partial absence of one X~     chromosome, affecting 1/2500 newborn female. It combines almost constantly short stature and~     ovarian failure with infertility.~      Other anomalies are inconstant: morphological characteristics of varying intensity,~     associated malformations, and increased risk of acquired diseases ...~      The prognosis of patients reaching the Turner Syndrome is linked to cardiovascular~     complications (congenital heart disease, dilatation of the ascending aorta with risk of~     dissection or rupture of aneurysm), causing early mortality with reduction of life expectancy~     of at least 10 years.~      For these reasons, screening for heart disease and dilatation of the ascending aorta is~     established and is intended to prevent the complications associated with medical treatment~     and / or surgery to increase life expectancy and reduce the co-morbidities.~      On the vascular level, the recommendations other than those relating to the monitoring of the~     diameter of the ascending aorta include research of renal artery stenosis by doppler~     ultrasound if the patient is hypertensive and looking for lymphedema.~      However, other arterial lesions were described in the literature, outside of the aneurysm of~     the ascending aorta. These peripheral arterial lesions can also be life and / or functional~     prognosis of the patient. Ascending aorta dilation seems not to be exclusive in Turner~     syndrome.~      In addition, specific vascular lesions outside the affected artery are described: hepatic~     cirrhosis by vascular depletion, lymphedema and varicose veins. The prevalence of venous or~     lymphatic disease is unknown.~      A single-center review of 9 cases of patients followed at the University Hospital of~     Strasbourg showed the presence of vascular lesions discovered incidentally during assessments~     performed for reasons other than cardiovascular screening: cystic lymphangioma, internal~     carotid aneurysm, agenesis of the inferior vena cava, early varicose veins, embryonic~     cerebral artery, etc ... None of these patients showed any dilatation of the ascending aorta~     or heart disease. Peripheral vascular abnormalities in this patient group are exclusive.~      In this study, we seek to demonstrate that arterial disease in Turner syndrome involve the~     entire arterial territory and is not confined to the ascending aorta. Screening for arterial~     lesions should be performed on the entire arterial vascular tree and regularly in the course~     of time, especially as the presence of cardiovascular risk factors increases with the age of~     these patients.~      The venous and lymphatic vascular damage in the literature and in our series of cases in~     University Hospital of Strasbourg description should also lead to the detection of these~     lesions.~      These vascular complications can be alone responsible for the reduction in life expectancy or~     responsible for serious morbidity. Improved screening of associated vascular lesions is~     necessary to enable the best prevention of cardiovascular complications.~      It is also to establish the prevalence of vascular anomalies, whether arterial, venous or~     lymphatic, to better understand the disease and its management. By collecting systematically~     karyotype leading to diagnosis, it may be possible to make a link between the genetic defect~     and heart or vascular disease.~   "
100603|NCT02250443|"~     This study is an open-label, long-term study for those patients who participated in the prior~     proof-of-concept protocol, in which the preliminary efficacy for BYM338 in patients with sIBM~     was demonstrated after a single 30 mg/kg i.v. dose of BYM338. This study is designed to~     confirm the efficacy, safety and tolerability of BYM338 in sIBM with long-term dosing.~     However due to lack of efficacy in patients with sIBM, the study was terminated early.~   "
100604|NCT02250430|"~     In this study, color (erythema) and pH will be measured on 3 consecutive days after~     application of 2 doses of SB204 to the cheeks of healthy volunteers.~   "
100605|NCT02250417|"~     Body position during sleep influences the severity of obstructive sleep apnea (OSA). The AHI~     is the number of times per hour of sleep that the airway temporarily collapses at the level~     of the tongue or soft palate. In a significant number of individuals with OSA, the severity~     of the condition as measured by the apnea-hypopnea index (AHI), increases in the supine~     (back) position and lowers in the lateral (side) position. This is called positional OSA.~      The primary objective of this study is to determine whether sleeping with a novel sleep~     surface (Wave sleep surface) that is used on top of a regular bed reduces the AHI in those~     with positional OSA.~   "
100606|NCT02250404|"~     This pilot research trial studies molecular signatures of the return of cancer after a period~     of improvement (relapse) in tissue samples from patients with small cell lung cancer who are~     receiving or planning to receive cisplatin and etoposide. Studying samples of tissue from~     patients with small cell lung cancer in the laboratory may help doctors learn more about the~     changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer~     relapse.~   "
100607|NCT02250391|"~     Patients with portal vein thrombosis, who have chronic liver diseases especially liver~     cirrhosis associated with low levels of AT III, will receive intravenous injection of NPB-06~     or placebo. The superiority of NPB-06 to placebo as anticoagulative agent will be verified in~     a randomized, double-blind, parallel-assignment design based on the proportion of patients~     obtained complete recanalization or partial recanalization of portal vein thrombosis.~      The safety of NPB-06 will be evaluated based on adverse events and adverse drug reactions~     (ADRs) observed between administration and 21 days after administration in comparison with~     the placebo group.~   "
100608|NCT02250378|"~     This pilot clinical trial studies the side effects and how well stereotactic radiosurgery~     followed by wedge resection works in treating patients with early stage non-small cell lung~     cancer that is located in the outer, or peripheral, areas of the lung. Stereotactic~     radiosurgery, also known as stereotactic body radiation therapy, is a specialized radiation~     therapy that delivers a single, high dose of radiation directly to the tumor and may kill~     more tumor cells and cause less damage to normal tissue. Wedge resection is a less invasive~     type of surgery for removal of the tumor and a small amount of normal tissue around it.~     Giving stereotactic radiosurgery followed by wedge resection may be a safe treatment option~     for patients who cannot receive standard treatment with lobectomy.~   "
100609|NCT02250365|"~     This study evaluates the effect of electrical somatosensory stimulation (ESS) on the~     restoration of upper limb functioning in acute stroke patients. The effect will be measured~     at the end of the intervention and six months post-stroke. We expect that ESS facilitates the~     restoration of upper limb functioning and the brain reorganization following stroke.~   "
100610|NCT02250352|"~     This research trial establishes a breast tumor tissue repository from core biopsies.~     Collecting breast tissue from core biopsies may allow doctors to learn more about the biology~     of breast cancer and to analyze proteins, genes, and other components of tumor cells. It may~     also allow doctors to conduct future studies to help understand how breast cancer grows and~     how it responds to different types of therapy. This will help doctors develop better breast~     cancer therapies and better tests to help make treatment decisions.~   "
100611|NCT02250339|"~     The purpose of this study is to examine the feasibility and the effects of family-based~     interventions for children (aged 5-12) with neuropsychiatric and psychiatric disorders in~     Finnish health care settings.~   "
100612|NCT02250326|"~     This is a Phase 2, open-label, multicenter study to assess the efficacy and safety of~     second/third-line treatment with nab-paclitaxel in combination with the epigenetic modifying~     therapy of CC-486 or immunotherapy of durvalumab, and nab-paclitaxel monotherapy in subjects~     with advanced non-small cell lung cancer (NSCLC).~   "
100613|NCT02250313|"~     The main hypothesis of this study is to demonstrate that the use of the ConfirmMDx for~     Prostate Cancer test in previously biopsied patients improves urologists' patient management~     by reducing unnecessary repeat biopsies, attendant procedure costs, and potential adverse~     events in men being considered for a repeat procedure.~   "
100614|NCT02250300|"~     This is a phase I/II study of MLN9708 for the prophylaxis of chronic~     graft-versus-host-disease (GVHD) in patients undergoing allogeneic hematopoietic stem cell~     transplantation (HSCT).~      During the phase I portion patients undergoing both sibling and unrelated donor~     transplantation were enrolled on the same arm to determine the dose-limiting toxicity (DLT)~     and maximum-tolerated dose (MTD).~      It was determined that the maximum tolerated dose is 4 mg. Phase I is closed.~      During the phase II portion of the trial, patients will be enrolled into two separate and~     independent cohorts: a) Matched sibling transplants and b) Unrelated donors transplants. Both~     cohorts will be enrolled and analyzed separately.~   "
100615|NCT02250287|"~     The purpose of this study is to establish normal Magnetic Resonance quantitative values~     (tissues stiffness, Apparent Diffusion Coefficient values and Blood Oxygen Level~     Determination values for both renal cortex and medullary tissues and total renal blood flow)~     for young Autosomal Dominant Polycystic Kidney Disease patients with normal renal function,~     and normal young adult controls without Autosomal Dominant Polycystic Kidney Disease and~     normal renal function.~      Hypothesis: Newer Magnetic Resonance quantitative imaging parameters (tissue stiffness,~     Apparent Diffusion Coefficient, Blood Oxygen Level Determination levels, Magnetization~     Transfer and renal blood flow) will have different values in young adult ADPKD patients as~     compared to normal volunteers.~   "
100616|NCT02250274|"~     The purpose of this study is to assess the serologic and cell-mediated immune response to~     licensed live attenuated influenza vaccine (LAIV) and inactivated influenza vaccine (IIV) in~     children 5-17 years old. The effects of prior infection and or prior season vaccination will~     be examined. Children will be followed during the influenza season to identify~     laboratory-confirmed influenza (i.e. vaccine failure).~   "
100617|NCT02250261|"~     Walking and cycling to work is a natural way of increasing lifestyle activity in working~     population. In Finland, active travel is acknowledged as one of the key components in the~     most previous policy documents and initiatives related to physical activity promotion.~     However, the evidence on the effectiveness and cost savings of environmental as well as~     social and behavioral strategies in promoting active travel is thin both nationally and~     internationally. This study focuses directly on this gap by 1) conducting a~     cluster-randomized, controlled intervention where environmental change is supported with~     social and behavioral strategies in a large workplace area in Tampere, Finland, 2) assessing~     the cost-effectiveness and health-economic impact of the intervention and 3) examining the~     environmental mediators and moderators of active commuting to work among working aged~     population.~      The study will be conducted in Hatanpää workplace area located just outside the city center~     and including hundreds of workplaces. Workplaces with the minimum of 10 employees are~     contacted for recruitment in August 2014. Baseline information is collected about the~     workplaces (web-based questionnaire), employees (questionnaire, accelerometer, travel log)~     and environment (traffic calculations and audit system, Geographic Information System=GIS)~     first in September-October 2014 and second in March-April 2015.~      In the first phase of the study a cycle superhighway across the workplace area is built by~     the City of Tampere. Its' effects on walking and cycling are assessed after immediate and~     mid-term (6 months) exposure with the same measures as at baseline in September-October 2015~     and second in March-April 2016. In the second phase, the workplaces are randomized to~     intervention and control group based on the most relevant factors related to their~     comparability. Each intervention workplace nominates an internal team, which develops a~     multilevel social ecological plan to promote active commuting to work. The research group~     supports the teams with material, examples and three meetings. The plan is executed in May~     2016 and the effects are assessed in September-October 2016 and March-April 2017. The~     work-places randomized to the control group in the second phase of the study participate only~     in data collection but are offered one supportive meeting for promoting active commuting to~     work after the study.~      Efficiency evaluation based on HEAT (Health economic Assessment Tool, www.euro.who.int/HEAT)~     and costs-to-effectiveness ratios are calculated in the end of the study for the combination~     of both phases as well as for the comparison of the phases. Environmental mediators and~     moderators related to active commuting to work are examined objectively at all evaluation~     points with GIS-analysis by connecting in-formation on physical environment to the routes,~     which employees are using for commuting to work. The information on estimated routes is~     obtained from the questionnaires (home and workplace addresses) and the information on actual~     routes from GPS, which a subgroup of employees will provide by using free-of-charge~     application (e.g. SportsTracker) in their smartphones.~   "
100618|NCT02250248|"~     The objective of this study is to evaluate the clinical success of AttraX Putty as a bone~     graft substitute for autograft in XLIF procedures.~   "
100635|NCT02250027|"~     The purpose of this study is to determine the optimal dose of HL301 in patients with acute~     bronchitis or acute exacerbations of chronic bronchitis.~      - BSS(Bronchitis Severity Score), BCSS(Breathlessness, Cough, and Sputum Scale), evaluation~     of symptoms of cough and sputum~   "
102326|NCT02227953|"~     The primary objective of this preliminary study is to investigate whether the transcranial~     direct current stimulation (tDCS) improves the cognitive function in patients with~     Alzheimer's disease~   "
100619|NCT02250235|"~     Helping patient with long-term conditions to make informed decisions about adherence to their~     treatment is an important element in facilitating self-management. Estimates of non-adherence~     to treatment in people living with long-term conditions are typically high, averaging at~     around 50%.This not only impacts negatively on patient outcomes but also places a significant~     financial burden on healthcare provision.~      While clinical efforts have focused on promoting patient self-management, with some success,~     work in Psychology on behaviour change has had little influence on clinical practice. In this~     project, the team wish to evaluate the potential for a novel intervention from the behaviour~     change literature, self-affirmation, to promote improved fluid control among non-adherent~     patients. The intervention works by promoting a patient's sense-of-self (self-affirmation),~     which has been shown to modify the patient's acceptance of health-risk information, their~     self-efficacy, their intention to change, and subsequently their behaviour.~      A randomised controlled pilot trial is proposed. The trial is designed to build upon routine~     education about fluid control during dialysis visits, and will compare a group of patients~     who have received an intervention to boost their sense-of-self (self-affirmation arm) to a~     control group (control arm). Patients in the self-affirmation arm should have a more positive~     evaluation of the health-risk information about fluid management, feel more able to, and~     intend to change their fluid control behaviour, and subsequently have lower interdialytic~     weight gain.~   "
100620|NCT02250222|"~     Ligand Pharmaceuticals Incorporated is developing LGD-6972, a novel, orally-bioavailable~     addition to diet and exercise to improve glycemic control in adults with type 2 diabetes~     mellitus. The mechanism of action of LGD-6972 is to reduce the excess liver glucose~     production characteristic of type 2 diabetes mellitus that is a major contributor to~     hyperglycemia. This clinical trial will evaluate the safety and tolerability of escalating~     doses LGD-6972 administered daily over 2 weeks in both healthy subjects and subjects with~     type 2 diabetes mellitus.~   "
100621|NCT02250209|"~     The objective of this study is to assess the clinical efficacy and safety of trastuzumab plus~     XELOX for treatment of HER2-positive Stage III Gastric Cancer After D2 Gastrectomy.~   "
100622|NCT02250196|"~     Colonoscopy is a common screening method to detect polyps and CRC. With the early detection~     of CRC through screening colonoscopy, patients could have better therapeutic effects and~     outcomes. In population screening programs, an increase in completed colonoscopies is related~     to a decrease in mortality from CRC. However, the miss rate for detecting colorectal~     neoplastic polyps of colonoscopy is 5-28%. The reluctance of participants to undergo bowel~     preparation results in the relatively low rate of detection of polyps and CRC, because poor~     preparation interferes with successful colon mucosa examination during a colonoscopy.~      Low-volume bowel preparations provide equivalent cleansing effect compared with standard 4~     liter polyethylene glycol. However, studies comparing the superiority between low-volume~     bowel preparations are rare, and results are controversial. This study aimed to compare the~     bowel cleansing quality and tolerability between split-dose sodium picosulfate/magnesium~     citrate and polyethylene glycol with ascorbic acid.~   "
100623|NCT02250183|"~     This study is designed to assess the efficacy of MEDIHONEY® Gel with Active leptospermum~     honey dressing relative to SANTYL® ointment dressing on time to heal, bacterial growth in the~     wound, patient satisfaction, and treatment costs in patients with partial thickness burns.~     The study has four hypotheses:~        1. It is hypothesized that MEDIHONEY® Gel with Active leptospermum honey will result in~          significantly faster wound healing (i.e., fewer days) when compared to SANTYL®.~        2. It is hypothesized that MEDIHONEY® Gel with Active leptospermum honey sites will yield~          significantly fewer positive cultures for Pseudomonas aeruginosa and other bacteria when~          compared to SANTYL® sites.~        3. It is hypothesized that patients will provide significantly higher patient care~          satisfaction ratings regarding their MEDIHONEY® Gel with Active leptospermum honey sites~          when compared to ratings with regard to their SANTYL® sites.~        4. It is hypothesized that treatment costs, across participants, will be significantly~          lower for MEDIHONEY® Gel with Active leptospermum honey than for SANTYL®.~   "
100624|NCT02250170|"~     This open-label, non-randomized trial will comprise of 2 parts. A dose escalation part will~     characterize the safety, biomarker and pharmacokinetics of OPB-111077 in advanced solid~     tumor. Subsequently, an expansion part will further evaluate the biomarker, safety,~     pharmacokinetics and antitumor activity of OPB-111077 in selected tumor types.~   "
100625|NCT02250157|"~     This study a nonrandomized, open-label, uncontrolled, single group assignment, safety and~     activity study in subjects with histologically or cytologically confirmed solid tumor that is~     metastatic or unresectable and for which standard curative or palliative measures do not~     exist or are no longer effective.~   "
100626|NCT02250144|"~     Patellofemoral pain syndrome is one of the most common musculoskeletal disorders. It is~     defined as an anterior knee pain. Its origin is a conflict during patellar tracking, due to~     patellofemoral malalignment and soft tissue overload.~      A few recent studies seem to show a benefit of prefabricated feet orthoses in patellofemoral~     pain syndrome, alone or in association with rehabilitation. However, no one has analyzed the~     outcome of morpho-specific foot orthoses in a prospective randomized study.~      The purpose of this prospective randomized study is to compare clinical outcomes in daily~     living and in sports activities, between morpho-specific and placebo foot orthoses.~      Morpho-specific foot orthoses are designed according to the patient's morphotype. They are~     intended to correct structural defects of the hindfoot, midfoot and forefoot, in the aim to~     correct abnormal overload during patellofemoral tracking.~   "
100632|NCT02250066|"~     investigators evaluated the efficacy of two types of diet with different macronutrients, on~     prevention or delaying the onset of type 2 diabetes in subjects with either impaired fasting~     glucose (IFG) or impaired glucose tolerance (IGT). 322 subjects with prediabetes were~     randomly assigned to high monounsaturated fat diet (n=107), high carbohydrate diet (n=106) or~     control group (n=109) and followed for 2 years. For calculating daily energy requirement in~     subjects with BMI≥25 kg/m2 the weight was adjusted with the use of 110 percent of the ideal~     body weight with no attempt for losing body weight. Control group were encouraged to follow~     the Food Guide Pyramid and reduce their fat intake to less than 30% of energy consumed and~     saturated fat to less than 10 percent of total energy. The primary outcome variable was~     incidence of type 2 diabetes mellitus, diagnosed by the latest American Diabetic Association~     criteria.~   "
100627|NCT02250131|"~     Previous studies (1-5) have demonstrated that oxygen delivery (DO2) and carbon dioxide~     production (VCO2) during cardiopulmonary bypass (CPB) are associated with renal outcome in~     cardiac surgery. The critical value for DO2 is around 262 - 272 mL/min/m2, and the~     correspondent critical value of DO2/VCO2 ratio is around 5.0.~      Patients with nadir DO2 and DO2/VCO2 ratio below these critical levels have an increased~     incidence of acute kidney injury (AKI) after cardiac operations.~      These observations offer an interpretation for the well-known deleterious effects of~     excessive hemodilution during CPB, supported by many studies where an association between~     nadir hematocrit (HCT) on CPB and bad outcomes (especially renal) was found (6-8). It is~     reasonable to hypothesize that a low oxygen delivery may determine an ischemic damage to the~     kidney, that due to its peculiar circulation is particularly susceptible to a decrease in the~     oxygen supply.~      However, there is no evidence that a strategy directed towards the specific goal of avoiding~     critical values of DO2 during CPB may actually decrease the postoperative AKI rate.~      The present study is designed to verify the hypothesis that a strategy based on a~     goal-directed perfusion, aimed to avoid a nadir DO2 below the critical threshold, is~     effective in limiting the postoperative AKI rate.~   "
100628|NCT02250118|"~     Metastatic pleural effusion is a common complication of late-stage cancer and reduces the~     quality of life and survival of patients. The survival of patients with recurrent pleurisy by~     uncontrolled local or systemic treatment is less than 6 months. It is important to develop~     specific therapies to improve the quality of life and survival of patients with metastatic~     pleurisy.~      Bevacizumab is a monoclonal anti vascular endothelial growth factor (VEGF) which has proven~     effective in many indications in oncology. Vascular endothelial growth factor (VEGF) is an~     angiogenic factor which increases endothelial permeability. It plays a central role in many~     tumors of epithelial origin. In this context, it is legitimate to ask whether an~     antiangiogenic targeting VEGF may be effective in patients with metastatic pleurisy by~     decreasing local blood supply and over-permeability.~      No study has been interested in the intra-pleural pharmacokinetics of monoclonal antibodies~     and there are no predictive or prognostic biomarkers for metastatic pleural effusions.~      The investigators believe that intrapleural administration of bevacizumab will reduce the~     pleural vasculature permeability. It will neutralize VEGF present in pleural fluid and reduce~     the replenishment of effusion due to its prolonged half-life of 21 days.~      The investigators therefore propose a phase I study to determine the maximum tolerated dose~     and the recommended dose for phases II, studying the pharmacokinetics of intrapleural~     bevacizumab administered by an implantable device after evacuating a symptomatic metastatic~     pleurisy as part of a mammary carcinoma. The VEGF intrapleural levels and serum will be study~     and the time until a new puncture. Dyspnea will be evaluated as well as its impact on quality~     of life.~   "
100629|NCT02250105|"~     This study is to evaluate the efficacy and safety of ARI-3037MO 3g BID compared to placebo in~     reducing triglyceride (TG) levels of subjects with severe (≥500 mg/dL and <2,000 mg/dL)~     hypertriglyceridemia. Eligible patients will enter a 4- to 6-week lead-in period (6-week~     washout for subjects on non-statin lipid-lowering therapy [subjects may remain on statins~     during this period], 4 weeks for patients on statins only or not receiving any type of~     lipid-lowering therapy), followed by qualifying fasting TG measurements at visits 2 and 3, at~     least 7 days apart. If the baseline TG value is > 500 mg/dL and < 2,000 mg/dL, the qualified~     subjects will be randomized at visit 4 and enter the double-blind, 12-week efficacy and~     safety assessment phase. End-of-study lipid levels will be assessed on visits 6 and 7 (weeks~     11 and 12 average). A final closeout and safety assessment visit will be done 14 weeks post~     randomization~   "
100630|NCT02250092|"~     Hemiparetic cerebral palsy influences motor function in children during development and~     throughout their lifetime. The deficits one sees are the result both of the congenitally~     induced brain lesion and the subsequent plasticity that can impair function of the surviving~     neurons in the damaged brain.~      Many current treatments have limited influence on children's neurorecovery.~     Constraint-induced movement therapy (CIMT) involving constraining the unaffected limb to~     encourage use of the affected limb has shown promise, yet with new technology revealing the~     potential to directly influence the brain, there is an urgent need to study the synergy of~     combined techniques.~      Non-invasive brain stimulation (NIBS) as a direct neuromodulatory intervention has the~     potential to act synergistically with CIMT to influence neurorecovery.~      Combining behavioral therapies, constraint-induced movement therapy (CIMT), with a novel form~     of neuromodulation, transcranial direct current stimulation (tDCS), we investigated the~     influence of this intervention on improved motor outcomes in children with cerebral palsy.~     The study hypotheses surround the safety, feasibility and efficacy of combined CIMT and tDCS~     wherein those children who receive the combined intervention will reveal no major adverse~     events, yet improved hand function and cortical excitability.~      To Note: In addition to the combination of NIBS with CIMT, we also investigated the~     combination of NIBS with another form of motor intervention, bimanual, or two-handed,~     training. During bimanual training, children engage both hands in movements. The goal of~     bimanual training is to teach children how to most effectively use their hands cooperatively.~     During bimanual training, children play with games and toys that require the use of both~     hands. Children also practice activities of daily living that require the use of both hands,~     such as putting hair in a ponytail, tying shoes, and buttoning clothing. N=8 for this pilot~     study and no randomization. (Burke Medical Research Institute partnered with Columbia~     University and did a parallel pilot study. N=8 (PIs Friel and Gordon; Protocol BRC449)~   "
100631|NCT02250079|"~     INTRODUCTION: Hypothermia in the newborn causes morbid conditions. In developing countries in~     the basic technology for neonatal adaptation may not be available. Polyethylene bags may be~     an alternative to lamp radiant heat to prevent hypothermia OBJECTIVE: To characterize the~     differences between babies undergoing body bag with polyethylene or conventional drying~     during neonatal adaptation in the Hospital de la Victoria and Hospital de Engativá, Bogotá,~     Colombia, 2013.~      MATERIALS AND METHODS: parallel-group randomized controlled trial. Groups: dried conventional~     (control) or polyethylene body bag (intervention). The procedure lasted 10 minutes, the bag~     body and / or radiant heat lamp was removed. Environment temperature and humidity,~     temperature in the body segments 1-5-10-60-120 minutes and APGAR was measured. Statistical~     Analysis: Descriptive bivariate statistical inference and calculated. Risk ratio (RR) and~     confidence intervals (CIs) were determined using contingency tables for risk analysis of the~     outcome. The study was approved by the hospital ethics committee of victory.~   "
100633|NCT02250053|"~     Despite the success of surgery and chemotherapy among people with colon cancer, 30-50% of~     patients develop recurrent disease. Physical activity has emerged as a potential lifestyle~     intervention to reduce cancer recurrence and improve survival among people with colon cancer~     (CC). This pilot study aims to identify the dose-response effects of aerobic exercise on~     molecular and cellular pathways associated with physical activity and CC outcomes among~     patients with stage II and III CC.~   "
103072|NCT02218229|"~     The shock wave is a new and potential intervention for the reinnervation of peripheral nerve.~     The purpose of this study was to assess the effect of extracorporeal shock wave therapy on~     carpal tunnel syndrome.~   "
100636|NCT02250014|"~     This randomized pilot phase I trial studies how well sargramostim after cryotherapy works in~     treating patients with prostate cancer. Biological therapies, such as sargramostim, use~     substances made from living organisms that may stimulate the immune system in different ways~     and stop tumor cells from growing. Cryosurgery, also known as cryotherapy, kills tumor cells~     by freezing them. Giving sargramostim after cryotherapy may work better in treating prostate~     cancer.~   "
100637|NCT02250001|"~     The primary objective of this study is: To evaluate the real-world safety, specifically the~     incidence rates of hepatic toxicity, pyrexia, and resistance, of DCV/ASV dual therapy in~     Japanese patients chronically infected with HCV GT-1.~   "
100638|NCT02249988|"~     The study is an open-label, randomized, comparative, multicenter clinical trial. The purpose~     of this study is to assess the efficacy of ABX203, a new chronic hepatitis B therapeutic~     vaccine administered as an adjunct therapy to nucleos(t)ide analogs (NUCs), in maintaining~     control of Hepatitis B disease after cessation of treatment with NUCs in subjects with HBeAg~     negative chronic Hepatitis B.~   "
100639|NCT02249975|"~     The purpose of this study is to assess the efficacy and performance of the C2 Focal~     Cryoablation System in patients with BE.~   "
100640|NCT02249962|"~     To characterize safety, durability, antiretroviral treatment (ART) resistance, and clinical~     outcomes for mothers and infants exposed to the efavirenz-based Option B+ regimen for~     Prevention of Mother to Child Transmission (PMTCT) and HIV treatment in Malawi.~   "
100641|NCT02249949|"~     This phase II trial studies how well efatutazone dihydrochloride works in treating patients~     with previously treated myxoid liposarcoma that cannot be removed by surgery. Drugs used in~     chemotherapy, such as efatutazone dihydrochloride, work in different ways to stop the growth~     of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading.~   "
100642|NCT02249936|"~     The study is designed to evaluate safety, tolerability, pharmacodynamics and pharmacokinetics~     of different formulations of AZD1722 in healthy male and female subjects taking Omeprazole.~   "
100643|NCT02249923|"~     Patients are being asked to be in this research study because medical researchers hope that~     by gathering information about a large number of children with pulmonary hypertension over~     time, their understanding of the disease process will increase and lead to better treatment.~     Investigators believe that pulmonary hypertension in children is different than pulmonary~     hypertension in adults and this study will help us understand those differences.~   "
100644|NCT02249910|"~     This trial is conducted in Europe. The aim of this trial is to investigate the influence of~     oral semaglutide on pharmacokinetics (the exposure of the trial drug in the body) of~     metformin and digoxin in healthy subjects.~   "
100645|NCT02249897|"~     There is evidence of the association between diabetic microangiopathy and elevated serum~     concentrations of advanced glycation end-products (AGEs). AGEs levels are associated with~     ingestion of specific foods (baked meats and milk powder); reducing their dietary intake~     lowers AGEs concentrations, with beneficial metabolic effects; however threre is still no~     evidence of whether this has an impact on microvascular complications of DM. We recently~     applied for funding to compare in a RCT the effects of Cholestyramine versus placebo, on~     visual electrophysiology. This drug is similar to Sevelamer in structure, both act as~     chelators of bile salts, and reduce absorption of dietary AGE, lowering serum levels. However~     it is essential to carry out preliminary tests to assess aspects that may imply adjustments~     to the proposed protocol, such as: 1) tolerance to the drug 2) short term effect of the drug~     versus placebo on serum levels of AGEs 3) effects of the drug versus placebo in levels of fat~     soluble vitamins (D and K specifically) 4) intra and interindividual variability of~     electrophysiological measurements of vision (ERGMF and optic nerve conduction velocity) 5)~     drug versus placebo in electrophysiological measurements of vision (neuroconduction ERGMF and~     optic nerve). Objective: The present project is planned as a pilot study, which will clarify~     points 1 to 5. Methodology: patients (6 DM2, 25 -50 y) will be assessed through~     anthropometry, clinical laboratory tests (creatinine, chemistry profile, lipid profile,~     microalbuminuria glycosylated hemoglobin, vitamin B12, 25OH vitamin D and prothrombin),~     dietary recalls specifically designed to analyze the regular consumption of AGEs, serum CML~     and neuro-ophthalmological study (fundus, ERGMF and optic nerve conduction). Subsequently~     each patient will be assigned to treatment with placebo for 3 months and then Cholestyramine~     6 g / day for 12 weeks and at the end of each period will be reassessed using the same~     methodology. If patients cannot tolerate the drug, they will be assigned to a reduced AGE~     diet.~      Expected results: Cholestyramine will have side effect similar to placebo (mainly digestive).~     The active drug and not placebo will reduce serum levels of AGEs and electrophysiological~     parameters of vision at 12 weeks. It is expected that a low AGEs diet in patients who do not~     tolerate the drug will also reduce serum CML although to a lesser degree and will also induce~     electrophysiologic changes.~   "
100646|NCT02249884|"~     Dose response curve to define the security and tolerable dose to be used for prevention and~     treatment of radiodermatitis in patients with breast or head and neck cancer.~   "
100647|NCT02249871|"~     This trial is conducted in Europe. The aim of this trial is to investigate the influence of~     omeprazole on the pharmacokinetics (the exposure of the trial drug in the body) of oral~     semaglutide in healthy subjects.~   "
100648|NCT02249858|"~     Osteopathic medicine is a distinct school of medicine. Osteopathic physicians evaluate the~     neuromusculoskeletal system and work to achieve normal body mechanics. They use palpation to~     identify somatic dysfunctions. After performing osteopathic manipulative treatment (OMT),~     such as high velocity low amplitude (HVLA), a dysfunction is reassessed by palpatory~     assessment. While there are studies which show the effectiveness of OMT, a challenge remains~     to objectively assess a somatic dysfunction.~      The purpose of this study is to investigate the content validity of the palpatory examination~     for the cervical spine using ultrasonography and the effects of a single cervical HVLA~     technique. Content validity is the extent to which a measure adequately and comprehensively~     measures what it claims to be measuring. The Investigators aim to objectively assess~     diagnosis and treatment of the cervical spine.~      HVLA technique employs a rapid, therapeutic force of brief duration that travels a short~     distance within the anatomic range of motion of a joint, and that engages the restrictive~     barrier in one or more planes of motion to elicit release of restriction. It is also known as~     a thrust technique. The goal of the treatment is the restoration of physiological motion to~     the dysfunctional joint.~      Proper diagnosis of a joint dysfunction is important for spinal manipulation. Little~     assessment has been made of the clinician's ability to reliably identify a joint with~     biomechanical dysfunctions. Few studies attempt to address the challenge of evidence-based~     clinical practice. These have found the benefit of consensus training.~      In a study conducted by Shaw et al., ultrasound machine was used to assess the content~     validity of palpatory examination and objectively assess the effect of HVLA in the lumbar~     spine. The investigators aim to adapt the protocol for the cervical spine, but with the~     addition of a control cohort. Subjects will be subjected to the cranial vault hold, which~     assesses the primary respiratory mechanism in and the degree of participation of each bone in~     the general motion of the cranium. In the experimental group, participants will be receiving~     cervical HVLA to the key somatic dysfunction.~      The Investigators hypothesize that an ultrasound is a reliable instrument to objectively~     evaluate somatic dysfunction of the cervical spine. Furthermore, the investigators~     hypothesize that after performing cervical HVLA, the left and right articular pillars of the~     key somatic dysfunction vertebrae should be symmetrical compared to baseline.~   "
100649|NCT02249845|"~     The assessment of clinical dehydration scales diagnostic accuracy (CDS scale, WHO scale,~     Gorelick scale) among small children.~   "
100650|NCT02249832|"~     The purpose of this study is to determine if intensive lower extremity robotic therapy can~     improve gait speed and functional ambulation status in individuals 6 months or greater~     post-stroke.~   "
108308|NCT02149771|"~     The purpose of this study is to determine whether TACE combined endovascular stent~     implantation confers a survival benefit over TACE alone.~   "
100652|NCT02249806|"~     PH is a serious disease with a dismal prognosis and impaired quality of life when left~     untreated. Reliable patient centered and prognostically relevant outcome measures are highly~     warranted in the field of PH. With this prospective cohort study the investigators intend to~     gain important information on the course of the disease and knowledge on the value of~     different new and already established outcome parameters.~   "
100653|NCT02249793|"~     As citizens of the information age, humans leave digital traces of behavior in their~     communication and movement patterns through our cell phone. The Global Positioning System~     (GPS) technology tracks the way persons commute to school or work or when visiting family and~     friends. Circadian rhythmicity describes the concept that many of the bodily functions follow~     a roughly 24-hour rhythm. Usually, the ability to do concentrated and focused work is best~     during daytime while humans rest and sleep during nighttime. The current study wishes to look~     for a relationship between patterns in participants' cell phone use (Android only at this~     point) and several of their bodily functions.~   "
100654|NCT02249780|"~     Evaluate parathyroid gland perfusion during total thyroidectomy or thyroid totalisation~     surgery. Create an objective basis for the decision whether or not to transplant the~     parathyroid glands. Avoide postoperative serum calcium and parathyroid hormone dosages, and~     thus abstention of systematic supplementation with calcium and vitamin D in case of good~     perfusion.~   "
100655|NCT02249767|"~     This was a double-blind, randomized, three-treatment, parallel study. Normal, healthy male~     and female children and adults (i.e., ages 12 to 40 years) with at least Grade 2 (i.e., mild~     severity) acne vulgaris were treated on the full face once daily for 84 days with the~     Tretinoin Gel 0.05%, Brand (tretinoin) Gel 0.05%, or Gel Vehicle. Acne lesions were graded by~     a single blinded observer at screening and at Weeks 0 (i.e., baseline), 2, 4, 8, and 12 at~     each location.~   "
100656|NCT02249754|"~     Building on the success of community-based peer education and counselling in breastfeeding,~     it is possible to address young child feeding and health practices in the surveyed district.~     Opportunities that can optimise success and encourage behaviour change in the district~     include mothers willingness to modify some feeding options; support of family members;~     seasonal availability and accessibility of foods; established set-up of village peers and~     existence of health centres and health staff in some villages. This study has developed a~     feasible, context-specific nutrition education package for use in rural Tanzania. The package~     is composed of 4 components, namely 1) education and counselling of mothers, 2) training of~     community-based nutrition counsellors, 3) sensitisation meetings with health staff and family~     members, and 4) supervision of community-based nutrition counsellors. The intervention will~     use a parallel cluster-randomised controlled trial design where infants will be recruited~     when aged 6 months and followed up for 9 months. The intervention expects to provide~     information and, where appropriate, recommendations to strengthen the nutrition component in~     the health education programme of the Tanzania child health services.~      The study hypothesises that the nutrition education package will be more effective than the~     routine health education in improving feeding practices, dietary adequacy and growth of~     infants and young children. Specific objectives of the study include:~        -  To evaluate the effectiveness of a nutrition education package on feeding practices and~          dietary adequacy~        -  To determine the effectiveness of a nutrition education package in improving growth and~          health of infants and young children~        -  To document the process of implementation of the nutrition education package to promote~          optimal feeding and health practice~   "
100657|NCT02249741|"~     Background and Objectives: Patients with liver cirrhosis are more prone to develop reduced~     bone mineral density i.e. hepatic osteodystrophy (HOD). It includes both osteopenia and~     osteoporosis and may lead to increased fracture risks. There is scanty data on prevalence of~     HOD in Indian population and its treatment outcome. The investigators aimed to determine~     prevalence of HOD, factors associated with it and the impact of bisphosphonates on bone~     mineral density in patients with liver cirrhosis.~      Patients and Methods: Consecutive patients with liver cirrhosis admitted at Sir Ganga Ram~     Hospital, New Delhi between August 2012 and July 2013 were enrolled. Patients with chronic~     kidney disease, hyperparathyroidism and those on steroids were excluded. Bone mineral density~     (BMD) was measured by dual-energy X-ray absorptiometry (DEXA) at the lumbar spine and femoral~     neck. Osteopenia and osteoporosis were defined according to WHO criteria. All patients also~     underwent 25-hydroxy-vitamin-D, sex hormone (testosterone in male and LH and Estradiol in~     female) and parathyroid hormone (PTH) along with routine investigations. Transient~     elastography was also done in all patients. Ibandronic acid 150 mg per day orally for six~     months was given in patients with osteoporosis and DEXA scan repeated.~   "
100658|NCT02249728|"~     The purpose of the study is to investigate how the test drug, PBT2, is taken up, broken down~     and removed from the body when given as an oral capsule, a radiolabelled oral suspension and~     a radiolabelled intravenous injection.~   "
100659|NCT02249715|"~     -  To characterize physiological biomarkers of positive response to rDTMS using EEG and~          functional MRI (fMRI) in patients with PD.~        -  To develop a set-up and algorithm for neurophysiological monitoring for PD patients~          using EEG and fMRI in patients treated by rDTMS.~        -  To integrate rDTMS stimulation with monitoring techniques with the ultimate goal of~          providing closed-loop feedback where monitoring informs the stimulation~   "
100660|NCT02249702|"~     The management of patients with uterine leiomyosarcomas poses many difficulties. Despite 60%~     of women present with disease limited to the uterus, cure rates range from 20 to 60%.~     Patients with metastatic disease at diagnosis or who recur after initial treatment have a~     dismal prognosis and, except for a subset of selected patients with completely resectable~     disease, the median survival is less than one year. Treatment options for~     recurrent/metastatic uterine leiomyosarcoma are limited. The most active drugs are~     doxorubicin ± ifosfamide and gemcitabine + docetaxel (GD) with response rate of 25-55% and~     27-53%, respectively. Both these regimens have been increasingly used in the last years also~     in the adjuvant setting. For relapsed patients other drugs have been tested as single agent~     but negligible activity was observed.~      Trabectedin (Yondelis® -T) is a marine-derived cytotoxic approved by EMEA. It is indicated~     for the treatment of patients with advanced soft tissue sarcoma, after failure of~     anthracyclines and ifosfamide or who are unsuitable to receive these agents. Among STS,~     activity has been mainly detected in synovial sarcoma, liposarcoma and leiomyosarcoma.~     Although the response rate did not exceed 10%, T was demonstrated to provide disease control,~     with progression arrest rates exceeding 50% and progression-free survival rates exceeding 20%~     at 6 months. So far no phase II studies tested the activity of T in uterine leiomyosarcoma~     specifically. This study is aimed at evaluating the activity of T (arm A) in advanced uterine~     leiomyosarcomas, having GD (arm B) as an internal control In parallel translational studies~     will be performed to identify factors predictive of the activity of T in this specific~     histotype.~   "
100661|NCT02249689|"~     Comparison of different contact lens materials.~   "
104314|NCT02202005|"~     The objective of this steady state pivotal study is to compare the rate and extent of~     absorption and to evaluate Bioequivalence of test drug compared to the approved reference~     product in HIV infected individuals~   "
100662|NCT02249676|"~     Neuromyelitis optica (NMO) is a demyelinating and degenerative disorder of the central~     nervous system affecting vision and brain and spinal cord function which leads to~     accumulating disability with a 5 year-mortality of approximately 30%. Survivors are typically~     left with severe morbidity secondary to blindness, quadriparesis and respiratory failure. No~     agent has been found to be highly effective in halting disease activity.Based on recent~     outcomes of Multipotent mesenchymal stromal cells in autoimmune diseases including multiple~     sclerosis, and based on the mechanisms of neuromyelitis optica, the investigators anticipate~     that mesenchymal stem cells transplantation may provide lasting disease stability for~     neuromyelitis optica patients.~   "
100663|NCT02249663|"~     To evaluate the therapeutic equivalence of a test formulation of Azelastine hydrochloride and~     Fluticasone propionate Nasal Spray to the reference listed drug, Dymista™ Nasal Spray in the~     relief of the signs and symptoms of Seasonal Allergic Rhinitis.~   "
100664|NCT02249650|"~     TSB-9-W1, prepared by Taiwan Sunpan Biotechnology Co., Ltd. (TSB) is a botanical drug and~     applied patent in the United States (US patent No. 7,138,428 B2), Japan (Patent No.~      5441947) and Taiwan (Patent No. I432191 and I282280). The R&D laboratory in TSB is ISO/IEC~     17025 certified by Taiwan Accreditation Foundation (TAF) and the laboratory number is~     2026.The trade name of TSB-9-W1 is IDS in English, the registration number is 01472800 at~     2011 by Intellectual Property Office (IPO), Taiwan.~      A phase I and pk study to determine the Maximum Tolerated Dose (MTD) and to evaluate the~     safety and efficacy profiles of TSB-9-W1 in pre-treated patients with metastatic colorectal~     cancer (mCRC).~      there are 5 cohorts and a minimal 2 patients and up to 30 patients are required at phase I.~      This is a single arm study. All eligible patients with mCRC will receive TSB-9-W1 treatment.~      Each treatment cycle is composed by a contiguous 2-day oral administration and a contiguous~     3-day rest. Patient should take the study drug once daily before meal with approximately 250~     ml or appropriate amount of water.~   "
100665|NCT02249637|"~     Given that both circumcision and orchidopexy are commonly done in a single setting, the~     investigators adopted the technique of orchidopexy via circumcision incision, particularly~     for palpable low inguinal cryptorchidism. In this paper, the investigators aim to present a~     novel technique and discuss our preliminary outcome of such procedure compared to the~     traditional inguinal-scrotal double incision technique. Specifically, the investigators aimed~     to determine the differences in operative time, testicular size changes, peri-operative~     complications, pain score and parent's satisfaction of both novel technique and conventional~     orchidopexy.~   "
100666|NCT02249624|"~     Twins who share a placenta but have two separate sacs of amniotic fluid~     (monochorionic-diamniotic) are at risk of developing twin-to-twin transfusion syndrome~     (TTTS). TTTS results from anastomoses in the placenta that lead to unequal sharing of blood,~     causing abnormal blood flow to the twins. The donor twin may have low fluid levels, poor~     growth, and anemia. The recipient twin can have high fluid levels, high red blood cell~     counts, heart failure, and hydrops. Having TTTS, especially if there is demise of one twin or~     if disease is severe enough to warrant laser photocoagulation of the anastomotic sites, puts~     the surviving fetuses at risk for brain injury due to hypoxia, ischemia, or reperfusion~     injuries. Magnetic Resonance Imaging (MRI) is superior to ultrasound at detecting subtle~     cerebral injuries. An MRI scoring scale has been developed for use in very low birth weight~     infants that has been shown to correlate with neurodevelopmental outcomes, but it has not~     been tested in this patient population.~      Our center's guidelines recommend fetal MRI prior to intervention, at 32 weeks gestational~     age, and on the infants at term corrected gestational age. Infants who were treated for TTTS~     in utero are seen in Nursery Follow-up Clinic at 4 months of age, 8 months of age, and for~     Bayley Scales evaluations at 15-18 months of age and at 2-3 years of age.~      The purpose of this study is to correlate brain MRI score with neurodevelopmental outcomes in~     survivors of TTTS that have either required fetal surgical intervention or had demise of~     their cotwin. The investigators predict that more severe white and gray matter injury as~     determined by the Woodward/Inder grading scale will be positively associated with worse~     neurodevelopmental outcomes.~   "
100667|NCT02249611|"~     The subjects will be recruited from July 1, 2014 until the participants enough. Interviewing~     for research purpose explication and informed consent will be collected before the study is~     executed. In the first 3 months, subjects of group A will use the mobile physical activity~     promotion tool (MT), receive professional personal counseling, and individualized reminding~     message (intervention) once a week. In the last 3 months, they will receive standard care~     (control) which is in support of behavioral and educational recommendations in diet control,~     increased physical activity, less smoking and drinking, deal with pressure, and regular~     health examination (based on the booklet of metabolic syndrome prevention which is edited by~     Health Promotion Administration, Ministry of Health and Welfare, Taiwan). Subjects of group B~     will begin with an initial 3 months control period of standard care only, and the~     intervention program will be conducted for last 3 months.~   "
100674|NCT02249520|"~     This is an extended pilot protocol to facilitate on-site calibration of the technical aspects~     of the new Siemens Biograph mMR (molecular MR) Positron Emission Tomography-Magnetic~     Resonance (PET-MR) scanner at the Cedars-Sinai Medical Center (CSMC) Biomedical Imaging~     Research Institute (BIRI) Research Imaging Core after scanner installation. The mMR is a~     FDA-approved standard clinical device (non-experimental) and will be used in accordance with~     clearance and approval from the FDA.~   "
100675|NCT02249507|"~     Aerobic exercise has the potential to diminish blood pressure values. The aim of this study~     is to determine whether this potential is also applicable for those with resistant~     hypertension and whether exercise intensity plays a role in this context. We hypothesize that~     performing an aerobic exercise session reduces blood pressure values in resistant~     hypertensive patients in a dose-response relation with exercise intensity.~   "
100676|NCT02249494|"~     The purpose of this study is to investigate whether the use of a mobile app could improve~     knowledge and practice in nutrition counseling performed by primary care physicians in~     Brazil.~   "
100871|NCT02246959|"~     In a 4-arm, randomized controlled trial, we will evaluate the relative effectiveness and~     cost-effectiveness of improving cholesterol levels among participants who are at high risk of~     CVD and who have elevated LDL cholesterol levels by testing process versus outcomes financial~     incentives. Participants will use electronic pill bottles that continuously monitor statin~     adherence. The primary outcome will be change in LDL cholesterol over 12 months.~   "
100668|NCT02249598|"~     In the future it is likely that we will replace the current schedule of injected vaccines~     with interventions that interrupt transmission of infections in more subtle ways. The agent~     that causes meningococcal disease (Neisseria meningitidis) colonises the nasopharynx of~     individuals. In most people, the bacterium is harmless and survives for months in the~     nasopharynx, however in a minority of people the bacteria can cause invasive disease.~      Simply reducing colonisation amongst target groups may protect them, and the rest of the~     population as well. In a previous study we investigated cross protective antibodies, and~     found incidentally that inoculating adult volunteers with Neisseria lactamica, a harmless~     `cousin` of N. meningitidis, possibly prevents N. meningitidis carriage. If true this could~     lead to novel mechanisms of reducing colonisation in targeted groups, possibly in the form of~     a nasal medication. The proposed study large experimental challenge study funded by~     Meningitis UK that will aim to establish if N. lactamica does or does not inhibit~     colonisation by N. meningitidis. We will also determine whether N. lactamica displaces~     existing N. meningitidis carriage, and whether there are individuals who are innately~     resistant to any Neisseria carriage. The study will recruit 300 volunteers between the ages~     of 1830yrs from the two universities in Sheffield. It will involve placing droplets of~     N.lactamica bacteria into the nose of half our group of volunteers, and a harmless water like~     solution into the nose of the other half of volunteers. We will carry out nose swabs at~     intervals over a six month period to establish if the pattern of N.meningitidis carriage is~     effected by N.lactamica colonisation. If the findings are positive we will perform future~     mechanistic investigations. A62.~   "
100669|NCT02249585|"~     The purpose of this study is to find out the effect of low abdominal pressure vs. standard~     abdominal pressure on the cardiac and respiratory function of the patients undergoing~     laparoscopic colon surgery in Trendelenberg position. It was also designed to evaluate the~     effect of the degree of neuromuscular blockade on the surgical condition of the patients~     undergoing laparoscopic colon surgery in Trendelenberg position.~   "
100670|NCT02249572|"~     The purpose of this study is to compare the outcome of patients with vestibular schwannomas~     in two groups of randomised to either radiosurgery or expectation.~      The optimal treatment for a small vestibular schwannoma is a matter of controversy and there~     are no class 1 studies investigating this. Even the natural tumor growth rate remains~     controversial and is reported to be from near 100% of cases showing growth to 40-60% in~     various reports. The clinical results of various treatment strategies are documented, but~     comparative studies are very few. Immediate radiosurgery or wait-and scan with subsequent~     treatment upon growth are two strategies that have both been used in many different centers.~     There are only two studies comparing these treatment modalities .These studies indicate~     significant effect of GKRS in reducing tumor growth, with less differences in hearing and~     complaint outcomes. None of the studies are blinded or randomised, allowing for bias.~      The present study aims at comparing the two modalities above. To achieve this, we intend to~     randomise patients with newly diagnosed VS to either of Wait-and Scan or immediate~     radiosurgery.~      The primary study endpoint is the relative tumor size measured as the ratio between tumor~     volume at four years compared with volume at inclusion. Secondary endpoints include symptom~     and sign development measured by clinical examination and by patient's responses to~     standardised validated questionnaires. In addition, the health economics involved with both~     strategies will be evaluated and compared, as well as the patient's working status.~      Patients will be asked to participate if their VS is diagnosed within the last six months,~     their age is between 18 and 70, and pending there are no exclusion criteria (see below). A~     power analysis indicates that about 50 patients per group is sufficient.~      In case of failure to recruit patients, we will change the design to a study based on~     patient's own choice of treatment.~      The study will be announced according to international guidelines. A steering committee will~     monitor the study and an intermediate analysis will be performed when the study group has~     been followed for two years. If the effect aim is already observed, the study should~     nonetheless continue, as it is too early to evaluate the results after such a short time~     course.~      It will also be discussed to do a follow-up of all patients ten years after inclusion.~   "
100671|NCT02249559|"~     This is a pilot study to evaluate the safety and efficacy of unilateral gamma knife~     subthalamotomy for Parkinson's disease in patients deemed poor candidates for deep brain~     stimulation.~   "
100672|NCT02249546|"~     Helicobacter pylori infection has been shown to be associated with the development of gastric~     cancer and peptic ulcer diseases. Eradication of H. pylori infection could reduce the~     occurence or recurrence of these diseases. The triple treatment including a proton pump~     inhibitor, clarithromycin, and amoxicillin or metronidazole to treat H pylori infection,~     proposed at the first Maastricht conference has become universal since all the consensus~     conferences and guidelines around the world recommended it. However, the eradication rate of~     clarithromycin-based triple therapy has been declining in recent years, probably related to~     the increasing resistant rate to clarithromycin. It was estimated that 15-20% of patients~     would fail from first line standard eradication therapy and need second line rescue therapy.~      The H. pylori persistence in human infections and its resistance to the drugs commonly used~     in antimicrobial therapy have been attributed not only to genetic variability, but also to~     ability of H. pylori to form biofilm as a strategy to overcome environmental stress and to~     protect itself. Several recent reports indicate that H. pylori forms biofilm either in vitro~     or in vivo, N-acetylcysteine (NAC) were thought to reduce and prevent biofilm formation. Two~     small-scale clinical trials showed NAC offers additive effect on eradication effects of H.~     pylori therapy. A recent trial showed N-acetylcysteine pre-treatment before a culture-guided~     antibiotic regimen is effective in treating refractory H. pylori infection.~      Aims: Therefore, we aim to assess~        1. Whether triple therapy containing N-acetyl cysteine is more effective than standard~          triple therapy~        2. the impact of antibiotic resistance and cytochrome P450 C19(CYP2C19) polymorphism on the~          eradication rate of triple therapy containing N-acetyl cysteine.~   "
100673|NCT02249533|"~     Sports-related traumatic brain injuries (TBIs), including mTBIs—commonly referred to as~     concussions—are a serious public health concern. Diagnostic criteria and consensus return to~     play (RTP) guidelines exist, but clinicians have varying approaches to the diagnosis and~     management of sports-related concussion as these guidelines are almost completely unsupported~     by an evidence base. It is well known that by increasing awareness of concussion signs and~     symptoms as well as the importance of addressing this injury, improving coaching on proper~     sports activity techniques and good sportsmanship, providing appropriate protective~     equipment, and quickly responding to injuries, the incidence, severity, and long-term~     negative health effects of sports-related concussion among children and adolescents can be~     reduced. The overall objective of this application, which is the first step toward attainment~     of our long-term goal, is to evaluate the effectiveness of Spot Light (a concussion injury~     management application [app] that coordinates diagnosis, management, and RTP procedures from~     injury to safe return to sport) when utilized by youth football teams. Our central hypothesis~     is that youth football teams randomized to receive SpotLight will report increased rates of~     concussion, increased referrals to physicians for care, and increased athlete compliance with~     RTP guidelines. The rationale that underlies the proposed research is that providing an easy~     to-use app has a high probability of effectively helping people involved with youth sports~     better recognize, respond to, and ensure athletes are fully recovered from sports-related~     concussion. We will test our hypothesis by pursuing the following aims: 1: Evaluate whether~     Spot Light will increase reported rates of sports-related concussion; Aim 2: Evaluate whether~     Spot Light increases referrals to physicians following concussion; Aim 3: Evaluate whether~     Spot Light improves the management of sports-related concussion. We expect to determine~     whether there is increased reporting, referrals to physicians, and athlete compliance with~     RTP guidelines. This contribution will be significant because it will allow physicians,~     athletic trainers (ATs), coaches, and parents to collaboratively track concussions from~     injury through safe RTP thereby lessening the chances of long-term negative outcomes as well~     as acute catastrophic outcomes.~   "
100677|NCT02249481|"~     Open-labelled, randomised controlled trial. Patients will be assessed pre-operatively, at 24~     and 48 hours for the primary outcome and secondary outcomes (except for Oxford Knee Score~     which will be assessed pre-operatively and at 6 months post-operatively by the ortho-paedic~     team).~      Primary Objective: To demonstrate whether adductor canal nerve infusions result in superior~     patient mobilisation within the first 48 hours following total knee replacement compared to~     femoral nerve catheter infusions.~      Secondary Objective: To identify whether adductor canal nerve infusions result in superior~     analgesia within the first 48 hours following total knee replacement compared to femoral~     nerve catheter infusions.~   "
100678|NCT02249468|"~     Difference in nutritional status between patients with mild and moderate Alzheimer's Disease~     (AD) and cognitively intact healthy people in an Asian population~   "
100679|NCT02249455|"~     To compare the efficacy of acapella and expiration against open glottis (ELTGOL) technique in~     promoting airway clearance of chronic obstructive pulmonary disease (COPD) patients~   "
100680|NCT02249442|"~     To determine the pharmacokinetics of single-dose and steady-state Tipranavir/Ritonavir~     (TPV/r) 500/200 mg in subjects with mild to moderate hepatic insufficiency~   "
100681|NCT02249429|"~     The main goal of this study is to determine the Maximum Tolerated Dose (MTD) and the~     Recommended Phase II Dose (RP2D) as well as preliminary antitumor activity of PQR309~     administered orally, as once daily capsules continuously and now on intermittent schedule in~     patients with relapsed or refractory lymphomas.~   "
100682|NCT02249416|"~     The objective of this study was to characterize the effect of two dose combinations of~     tipranavir/ritonavir (TPV 500 mg/RTV 100 mg and TPV 750 mg/RTV 200 mg) administered twice~     daily on the pharmacokinetics (PK) of zidovudine (ZDV) and zidovudine-glucuronide (GZDV) as~     well as the effects of zidovudine on the pharmacokinetics of TPV/RTV~   "
100683|NCT02249403|"~     The objective of this trial was to assess the dose-response relationship of symptomatic~     efficacy of talsaclidine base on ADAScog and to assess safety and tolerability~   "
100684|NCT02249390|"~     The purpose of the study is to collate local information to better understand the~     motivations, accessibility and frequency of assisted reproductive technology (ART) use in the~     community.~   "
100685|NCT02249377|"~     This is a Prospective study with Randomized patients into either Ultrasound-guided~     Platelets-Rich-Plasma injection and Ultrasound guided Corticosteroid Injection, with 3 months~     and 6 months follow ups after aspiration at our institution. There will be 25 patients in~     each group, including any patient with symptomatic baker's cyst.~   "
100686|NCT02249364|"~     Hypnosis may reduce patient anxiety. The main goal of this study is to determine in what~     extent, hypnosis decreases propofol requirement to induce induction of general anesthesia.~      Two particular aspects of this study are~        -  the inclusion of women undergoing one day gynecological surgical procedures~        -  the use of a closed-loop system which delivers propofol according to bispectral index to~          provide induction of anesthesia.~   "
100687|NCT02249351|"~     Study to assess symptomatic efficacy, safety and tolerability of talsaclidine in patients~     with mild to moderate dementia of Alzheimer type~   "
100688|NCT02249338|"~     Study to investigate the effect of 14-day treatment with BIIL 284 BS on sputum neutrophils~     and specific inflammatory markers in patients with clinically well-defined moderate chronic~     obstructive pulmonary disease (COPD)~   "
100689|NCT02249325|"~     This pilot quasi experiment was designed to determine the feasibility of a randomized~     controlled trial of the oral probiotic combination of Florajen3 (>7.5 x109 L. acidophilus,~     >6.0 x109. B. lactis, and >1.5 x109 B. longum) taken orally once daily beginning at 28 weeks~     gestation, against placebo, to reduce the colonization of group B Streptococcus at 36 weeks.~   "
100690|NCT02249312|"~     Study to evaluate the anti-inflammatory effect of BIIL 284 BS compared with placebo in~     patients with asthma~   "
100691|NCT02249299|"~     Adult patients with ADHD commonly report an improvement in behavioural symptoms when using~     cannabis with some reporting a preference towards cannabis over their ADHD stimulant~     medication. The EMA-C study aims to investigate the effects of a cannabis based medication,~     Sativex Oromucosal Spray on behaviour and cognition in adults with ADHD.~      This will be carried out by conducting a placebo controlled trial. 30 adults with ADHD will~     take Sativex or a dummy medication (a placebo) every day for 6 weeks. There is a 50% chance~     of receiving the Sativex or Placebo. Measures of behaviour and cognition will be taken before~     and after 6 weeks of treatment. We hypothesise that treatment with Sativex will result in~     improvements in behaviour and cognition above that of the placebo group.~   "
100692|NCT02249286|"~     In Ethiopia, a child-centered counseling approach is hypothesized to be more effective than~     the current nutrition and health education when investment on home-based food production is~     used as a platform for nutrition education. This project is proposed to evaluate the efficacy~     of a food-based package integrating child-centered nutrition counseling and home-based food~     production using a between-group comparative intervention study. The intervention comprises~     child-centered nutrition counseling for caretakers and support for 'developed' gardens and~     improved backyard poultry production.~   "
100706|NCT02249104|"~     The goal of this study is to evaluate a complete topical acne regimen consisting of a~     prescription acne medication (Epiduo® Gel) and an acne-specific cleanser (Cetaphil®~     DermaControl™ Foam Wash) and moisturizer with sunscreen (Cetaphil® DermaControl™ Moisturizer~     SPF 30) for safety, efficacy and patient satisfaction in student athletes with acne vulgaris.~   "
100707|NCT02249091|"~     Acute Myeloid Leukemia (AML) is currently treated with chemotherapy by combining several~     drugs with different ways of inhibiting the cell growth. In this trial, standard~     chemotherapeutics that have proven their effectiveness for years, Ara-C and Idarubicin, will~     be combined with a new drug called Selinexor.~      Selinexor inhibits the growth of cancer cells by keeping certain proteins in the nucleus~     which control the cell growth.~   "
100805|NCT02247817|"~     Cardiac resynchronization therapy has become one of the cornerstones of the treatment of~     heart failure. However, a large proportion of patients still fails to this type of therapy.~     This may be due to a suboptimal position of the left ventricular pacing lead, which may be~     caused by unfavorable cardiac venous anatomy. Implantation of the pacing lead using video~     assisted thoracic surgery is more flexible and evades the venous system altogether, resulting~     in a much more favorable position of the pacing lead, with better treatment results as e~     consequence.~   "
100693|NCT02249273|"~     Background: Inappropriate use of antibiotics is one of the main causes for the increase of~     antibiotic resistance strains. In Denmark general practice accounts for 90% of all prescribed~     antibiotics and one of the most common reasons for prescribing antibiotics is the suspicion~     of a urinary tract infection (UTI). The use of point-of-care test is meant to decrease the~     uncertainty about the bacterial origin of the symptoms; however, there is a paucity of~     knowledge about the validity of the different diagnostic approaches, thus impacting on the~     proper use of antibiotics.~      Objective: To assess the diagnostic validity of different diagnostic approaches in patients~     with a suspected urinary tract infection and assess the impact on appropriate use of~     antibiotics.~      Methods: 70 practices at the capital region will consecutively include 15-20 patients. The~     inclusion criteria of the patients comprise: a) Suspected Urinary tract infection, b) > 18~     years of age, c) patient consulting during office hours. Data at patient and GP level will be~     gathered.~      16 diagnostic approaches will be compared and proper use of antibiotics will be assessed as a~     two-step process. The first step is the decision made during the consultation and the second~     step is the decision made after the consultation. Sensitivity, specificity and predictive~     values will be measure for each diagnostic approach using urine culture as a gold standard.~     The impact on proper use of antibiotics will be assessed in a hierarchical multivariable~     logistic model.~   "
100694|NCT02249260|"~     Outcomes evaluation is a critical component in outpatient cardiac rehabilitation. The aim of~     this study is to examine factors who predict long-term effects of improved peak oxygen uptake~     one year after participating in cardiac rehabilitation.~      Secondary to evaluate the short and long-term outcome of a 12-week outpatient cardiac~     rehabilitation program.~   "
100695|NCT02249247|"~     Study to investigate the effect of 12-week treatment with three doses (5, 25 and 75 mg) BIIL~     284 BS on exercise endurance, lung function, quality of life, spontaneous sputum and safety~     in patients with chronic obstructive pulmonary disease (COPD)~   "
100696|NCT02249234|"~     There are no previous reports on the use of OnabotulinumtoxinA (Botox) to treat men with~     scrotal pain that we found published.~      We proposed a pilot study using Botox to block the nerves on a small group of men with~     chronic scrotal pain (CSP) who have failed the standard medical therapy. The men must have~     had temporary relief from a testicular cord block using local anaesthetic drug.~      The encourage results of the pilot study has given us the background information to proceed~     with a formal randomised control trial of Botox vs placebo.~      We hypothesized that Botox injections to block the testicular nerve will be effective in~     providing long term pain relief for men with scrotal pain.~   "
100697|NCT02249221|"~     The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of~     GC3106 after single intramuscular administration in Korean healthy adults.~   "
100698|NCT02249208|"~     The purpose of this study is to determine the detection rate and the false negative rate of~     sentinel lymph node (SLN) by superparamagnetic iron oxide (SPIO) alone or in addition to~     radioisotope and compared to the standard method (blue and radioisotope) after neoadjuvant~     chemotherapy in patients with node-positive breast cancer converted to node negative after~     treatment by ultrasound. A randomized controlled trial.~   "
100699|NCT02249195|"~     Study will recruit pregnant or postpartum women presenting to Groote Schuur Hospital with~     cardiovascular disease in 20 consecutive patients and will insert an implantable ECG~     monitoring device. The patient will then be followed up over a duration of two year and will~     be monitored for arrhythmia and mortality.~   "
100700|NCT02249182|"~     This study will have two parts as follows:~      The PK Lead-in Phase of the study will evaluate the steady state pharmacokinetics (PK) and~     confirm the dose of ledipasvir/sofobuvir (LDV/SOF) fixed dose combination (FDC) in hepatitis~     C virus (HCV)-infected pediatric participants. The PK Lead-in Phase will also evaluate the~     safety, tolerability, and antiviral activity of 10 days of dosing of LDV/SOF FDC in~     HCV-infected pediatric participants.~      The Treatment Phase will be initiated by age cohort after confirmation of age-appropriate~     LDV/SOF FDC dosage levels. Participants from the PK Lead-in Phase will immediately rollover~     into the Treatment Phase with no interruption of study drug administration. The Treatment~     Phase will evaluate the antiviral efficacy, safety, and tolerability of LDV/SOF FDC +/-~     Ribavirin (RBV) for 12 or 24 weeks in pediatric participants with HCV.~   "
100701|NCT02249169|"~     This longitudinal study is being done to understand mechanisms underlying development of~     irritable bowel syndrome (IBS) and the role of the gut bacteria in development of symptoms.~     This information will be used to determine whether temporal changes in gut microbial taxonomy~     and metabolism are associated with changes in symptom severity in IBS, and if targeted~     dietary interventions, including prebiotics, can reverse or moderate these changes.~   "
100702|NCT02249156|"~     Several employers in the US have introduced a program where their employees receive a~     financial incentive to receive lower cost care. Under this Rewards program, patients are~     free to choose providers but if they visit a pre-determined low-cost laboratory or radiology~     facility (called a rewards provider), they receive a financial incentive. The financial~     incentive is typically in the form of a Health Savings Account (HSA) contribution. The dollar~     amount varies by employer. This study will use medical claims data to examine if this program~     leads to an increase in the volume of services performed by low-cost providers and decreased~     health care spending.~   "
100703|NCT02249143|"~     The primary aim of this study is to quantify and compare changes in lung volumes (as measured~     by functional residual capacity) in premature infants stable on continuous positive airway~     pressure (CPAP), and then randomized to two additional weeks of CPAP and room air versus room~     air alone. We hypothesize that infants randomized to additional CPAP will demonstrate an~     increased functional residual capacity (at the end of the two week study period and prior to~     discharge) compared to those randomized to room air.~   "
100704|NCT02249130|"~     To investigate the safety of a standard triple therapy regimen of delavirdine (DLV),~     zidovudine (ZDV), and lamivudine (3TC) following 14 days of experimental treatment with~     regimens of tipranavir (TPV) with and without ritonavir (RTV)~   "
100705|NCT02249117|"~     Study to compare the pharmacokinetic and pharmacodynamic effects of escalating dosages of~     recombinant human pyro-Glu MCP-1 (BIWH 3) in Duffy positive vs. Duffy negative healthy male~     volunteers: plasma levels of monocyte chemotactic protein-1 (MCP-1) and markers of leukocyte,~     coagulation, platelet and endothelial activation will be quantified; To examine the safety of~     BIWH 3 in this setting~   "
100708|NCT02249078|"~     This is a multicenter, Phase 1b, randomized, double-blind, placebo-controlled,~     sequential-cohort, multiple ascending dose (MAD) study to evaluate the safety, tolerability,~     pharmacokinetics (PK), and pharmacodynamics (PD) of 3 subcutaneous and 1 intravenous dose of~     E6011 in subjects with active Crohn's disease (CD). Thirty-two subjects will be randomized to~     one of 4 dose cohorts (8 per cohort) and will receive E6011 or placebo for 10 weeks. The~     first 3 cohorts will receive E6011 or placebo via subcutaneous injection and the last cohort~     will receive E6011 or placebo by intravenous injection. The ratio of E6011 to placebo within~     each cohort will be 3:1. The study has 2 phases: Prerandomization and Randomization.~   "
100709|NCT02249065|"~     This study is designed to:~        1. assess the signs and symptoms of rosacea, including erythema, without treatment and~          during treatment with Mirvaso® gel~        2. further characterize lifestyle impact and patient satisfaction with Mirvaso® treatment~        3. gain a better understanding of the real-world use of Mirvaso® on the pattern and~          management of facial erythema of rosacea.~   "
100710|NCT02249052|"~     The purpose of this study is to determine whether collagenase is effective in reducing the~     surface area of a subcutaneous benign lipoma.~   "
100711|NCT02249039|"~     Critically ill infants and children who are mechanically ventilated are often given large~     doses of opiates and benzodiazepines to provide analgesia-sedation. These drugs significantly~     cause tolerance and dependence, depresses the drive to breathe, and thus prolongs the need~     for mechanical ventilation and the associated complications. We propose IV CLON could be used~     as effectively as DEX.~   "
100712|NCT02249026|"~     Summary: There have been two published RCTs showing efficacy of buprenorphine treatment for~     NAS. However these trials excluded an estimated 22-47% of infants requiring pharmacologic~     treatment; those infants born to mothers with co-dependence on an opiate and a~     benzodiazepine. Although there are concerns, we anticipate that buprenorphine will be safe in~     this population. If it is safe, we can include these infants in the large double blind,~     double-dummy buprenorphine and clonidine vs. morphine and clonidine trial. If on the other~     hand, these infants have respiratory depression or other adverse events when buprenorphine is~     given, it will be important to report this study and caution the use of buprenorphine in~     these infants~   "
100713|NCT02249013|"~     This is a phase II open label, single arm clinical trial on safety and efficacy exploring an~     short-course regimen of intra-operative Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for~     patients with advanced Epithelial Ovarian Cancer (EOC) undergoing fast-track Cytoreductive~     Surgery (CRS) after Neoadjuvant Chemotherapy (NACT).~   "
100714|NCT02249000|"~     First-in-Human clinical investigation to evaluate the safety and clinical performance of the~     BIOVALVE prosthesis in subjects presenting with severe symptomatic aortic valve stenosis,~     which are as judged by the heart team, indicated for transfemoral transcatheter aortic valve~     implantation~   "
100715|NCT02248987|"~     The purpose of this study is to evaluate abnormal dopamine synthesis and connectivity~     according to the antipsychotic treatment response in schizophrenia.~   "
100716|NCT02248974|"~     The goal of this project is to develop a patient-centered decision aid for decision-making~     about end-stage heart failure treatment. This study seeks to create a decision aid that~     presents outcomes, risks, projected experiences, and uncertainties about Left Ventricular~     Assist Device (LVAD) placement to help patients make values-based decisions about placement.~     The investigators propose a mixed methods design involving a literature search of clinical~     evidence, semi-structured patient interviews, and quantitative data from a multi-site trial~     of patients receiving the decision aid compared to patients not receiving the aid.~   "
100717|NCT02248961|"~     Assess and compare the efficacy and safety of Kanarb (Fimasartan), manufactured by Boryung~     Pharmaceutical Co., Ltd, Republic of Korea, tablets 60/120 mg and Cozaar® (Losartan),~     manufactured by MERCK SHARP & DOHME B.V., Netherlands, tablet 50/100 mg in adult patients~     with Grade I-II arterial hypertension in 12 weeks of therapy~   "
100718|NCT02248948|"~     This study aims to evaluate the efficacy of an Omega-3 Fatty Acid Supplement on improving the~     Attention Deficit Hyperactivity Disorder (ADHD) clinical symptoms.~   "
100719|NCT02248935|"~     The purpose of the study is to determine the clinical cure rates of pelvic organ prolapse~     from subjects that had a robotic-assisted sacrocolpopexy using Alyte Y mesh and Restorelle Y~     smartmesh lightweight mesh.~   "
100720|NCT02248922|"~     The purpose of the study is to evaluate lung clearance index (LCI) by a standardized~     procedure in a well characterized study setting and to assess feasibility of LCI as a more~     sensitive method than forced expiratory volume at 1 second (FEV1) to measure effectiveness of~     antibiotic therapy in patients with CF aged 6 years and older with mild to moderate lung~     disease.~   "
100721|NCT02248909|"~     This study is an observational multicenter descriptive study. The study will be conducted in~     primary outpatient medical institutions in different cities of the RF. Primary care doctors~     who are primary contact for greater part of the population in RF including COPD patients will~     be invited as investigators. This observational descriptive study will be conducted within~     the routine practice of outpatient institutions. Since spirometry is not an integral part of~     the current all-round clinical practice, only those sites where spirometry test is routinely~     used in examination of patients with COPD risk factors and when monitoring condition of COPD~     patients will take part in the study. Thus the decision about spirometry in every study~     subject will be determined only by the existing treatment approaches.~   "
100722|NCT02248896|"~     The primary objective of this study was to assess whether there is an increased risk of~     sepsis with the use of telmisartan compared with other ARBs and with the other major~     antihypertensive classes, including ACEIs, beta-blockers, CCBs and thiazide diuretics. A~     secondary objective was to assess whether the use of ARBs and ACEIs, compared with the other~     three major antihypertensive classes and with untreated hypertension, is associated with an~     increased risk of sepsis. A third objective was to evaluate whether the use of telmisartan~     compared with other ARBs, ACEIs and other major antihypertensive classes is associated with~     an increased risk of worse outcomes due to sepsis, in particular acute kidney injury and~     death~   "
100723|NCT02248883|"~     To demonstrate that tipranavir (TPV) co-administered with ritonavir (RTV) does not affect the~     QT interval more than placebo co-administered with ritonavir~   "
109796|NCT02130284|"~     This study is a multi-center, single arm and in-clinic study to evaluate the safety of the~     PLGM System and its algorithm with the Enlite 3 Sensor.~   "
100724|NCT02248870|"~     Prolongation of the analgesic effect of a femoral nerve block from the present 15 hours to 24~     hours in patients with hip fracture would have a major impact in order to provide better~     preoperative analgesia for this group.~      In other trials concerning other nerves then the femoral nerve the addition of Dexamethasone~     to the local anesthetics doubled the analgesic duration. No studies has investigated the~     effect of the addition of Dexamethasone to the femoral nerve block in patients with hip~     fracture.~      The aim of our study is to investigate if more patients with hip fracture experience lasting~     preoperative analgesia until the time of operation or 20 hours after a femoral nerve block~     with the addition of Dexamethasone compared to the same nerve block done without~     Dexamethasone.~   "
100725|NCT02248857|"~     The purpose of this study test the effectiveness of the Universal Medication Schedule (UMS),~     which was designed as a strategy to standardize and simplify medication instructions to~     support safe and effective prescription drug use among diabetic.~   "
100726|NCT02248844|"~     This is a postmarketing surveillance study in Korea to evaluate the safety and effectiveness~     of BOTOX® for lateral canthal lines (crow's feet lines) with or without simultaneous~     glabellar lines.~   "
100727|NCT02248831|"~     Historically, ultrasound imaging of the lung parenchyma has been challenging because of the~     high total ultrasound energy attenuation and scattering by the air in the lungs. However,~     recent technological advancements have allowed for rapid assessment of various pulmonary~     diseases via the use of lung ultrasound. Furthermore, it has been shown that clear~     reproducible Doppler signals can be recorded from the lung parenchyma by means of a pulsed~     Doppler ultrasound system incorporating a special signal-processing package.~      The LDS may contain information of significant diagnostic and physiological value regarding~     the pulmonary parenchyma and vasculature, as well as the cardio-vascular system in general.~     In a pilot clinical validation study of patients with acute decompensated heart failure~     (ADHF) patients, LDS signals unique to ADHF patients were identified, that superpose on the~     normal Lung Doppler Signals (unpublished data). These are high velocity disorganized~     variable signals that are not synchronous with the cardiac cycle but rather sometimes with~     respiration.~   "
100728|NCT02248818|"~     This is a randomized, double-blind, placebo-controlled study of single and multiple ascending~     dosage levels of AZD8108 in healthy volunteers. The study includes an up to 28-day screening~     period, an in-house period during which AZD8108 or placebo will be administered orally as a~     solution, and a 4- to 10-day follow-up period after discharge.~   "
100729|NCT02248805|"~     The primary goal of this Phase 1 study is to characterize the safety and tolerability of~     MGD007 and establish the maximum tolerated dose (MTD) and schedule of MGD007 administered to~     patients with metastatic colorectal carcinoma. Pharmacokinetics, pharmacodynamics, and the~     anti-tumor activity of MGD007 will also be assessed.~   "
100730|NCT02248792|"~     Methotrexate (MTX) is considered the 'gold-standard' drug for the treatment of severe~     psoriasis. Health-related quality of life (HRQOL) is impaired in patients with psoriasis,~     more so if disease is severe.~   "
100731|NCT02248779|"~     The purpose of this study is to better understand the risk factors and causes of diabetes in~     people who received radiation to the abdomen as children. The investigators hope this~     information will allow them to improve how they screen people at risk for diabetes and how~     they treat patients in the future.~   "
100732|NCT02248766|"~     The aim of this dispensing study is to evaluate the clinical performance of existing wearers~     of Avaira toric lenses following a refit with Clariti toric over 1 month of daily wear.~   "
100733|NCT02248753|"~     A symptomatic episode of the heart rhythm disorder 'atrial fibrillation' (AF) is a frequent~     reason for visits to the emergency department. Currently, in the majority of cases, immediate~     (electrical or pharmacological) cardioversion is chosen, while atrial fibrillation terminates~     spontaneously in 70% of the cases within 24 hours. A wait-and-see approach with rate-control~     medication only, and when needed cardioversion within 48 hours of onset of symptoms, could be~     effective, safe and more cost-effective than current standard of care and could lead to a~     higher quality of life.~   "
100734|NCT02248740|"~     The aim of this study is to perform a randomized, prospective trial comparing the two current~     methods of treatment for chronic venous insufficiency related to the Small Saphenous Vein~     (SSV) to evaluate complications and outcomes for each method, and ultimately, to see if one~     is superior to the other.~   "
100735|NCT02248727|"~     The aim of this dispensing study is to evaluate the clinical performance of existing wearers~     of Avaira sphere lenses following a refit with Clariti Elite sphere over 4 weeks of daily~     wear.~   "
100736|NCT02248714|"~     The purpose of the study is to evaluate the effect of Glucerna SR treating newly-diagnosed~     type 2 diabetes patients (NDM) on glycemic stability, with the application of CGMS~     (continuous glucose monitoring system) and to further realize the safety and effect of~     Glucerna SR on daily and day-to-day amplitude of blood glucose fluctuation.~   "
100737|NCT02248701|"~     The purpose of this study is to determine whether testosterone plus finasteride treatment~     will improve musculoskeletal health, neuromuscular function, body composition, and metabolic~     health in hypogonadal men who have experienced ambulatory dysfunction subsequent to~     incomplete spinal cord injury. The investigators hypothesize that this treatment will improve~     bone mineral density, enhance muscle size and muscle function, and improve body composition,~     without causing prostate enlargement.~   "
100738|NCT02248688|"~     The purpose of this pilot study is to achieve the collection of safety and efficacy data in~     patients undergoing left gastric artery embolization for morbid obesity in the United States.~     As secondary goal, the pilot study seeks to obtain quality of life data. This pilot study is~     not designed to achieve new indications for this device.~   "
100739|NCT02248675|"~     There is a strong association between sleep disturbance and suicidal thoughts and behaviors.~     Sleep disturbance is also highly comorbid with other common conditions associated with~     suicide such as depression and posttraumatic stress disorder. Accordingly, this application~     focuses on improving sleep as a novel suicide prevention strategy that can be delivered to a~     broad range of Veterans. This pilot proposal specifically examines how Cognitive Behavioral~     Therapy for Insomnia, an efficacious treatment for insomnia, may reduce suicidal ideation in~     Veterans who also suffer from additional conditions. The proposal further suggests that~     adding this sleep intervention to usual care may further enhance overall care by increasing~     the utilization of recommended treatments for depression and posttraumatic stress disorder.~   "
100740|NCT02248662|"~     Despite the large number of women affected, the optimal treatment strategy for DCIS is not~     known. To enable informed decision-making by DCIS patients, we seek to provide individualized~     data about outcomes following breast conserving-surgery with and without radiation therapy -~     in terms of recurrence, disease-free and overall survival, and likelihood of long-term breast~     conservation. To do this, we will study patient-specific risk factors for having a new breast~     cancer after DCIS and the likelihood of breast-conserving surgery versus mastectomy if a~     woman has a 2nd cancer diagnosis after DCIS and has not received radiation upfront, using 4~     large datasets. The results of these analyses will then be combined into a model which will~     generate individually tailored predictions of the long-term likelihood of breast conservation~     with and without radiation therapy for DCIS. We will then design a web-based decision aid to~     present the tradeoffs and compare expected treatment outcomes with and without radiation~     therapy. This decision aid will enable patients and their physicians to choose the treatment~     most consonant with patient preferences, and will improve both the quality of decision-making~     and quality of life for patients diagnosed with DCIS.~   "
100741|NCT02248649|"~     This project is investigating whether a home-based exercise program will reduce cognitive~     decline in patients with Parkinson's disease.~   "
100742|NCT02248636|"~     This study tries to determine if stopping certain medications that are used to treat dementia~     will cause worsening from the patient and family perspective.~      All of the participants will take pills that look identical, and that may contain active drug~     or an inactive pill (a placebo). Half of the group will receive the same treatment they were~     taking before the study -- this is called the sham discontinuation arm. The other half will~     receive a reduced dose of their medication, and then an inactive pill (placebo) -- this is~     called the real discontinuation arm.~      Participants will be able to return to their previous dose of medication at any time during~     the study. The percentage of people who return will be measured and compared. Other medical~     events and factors such as behaviors, thinking, and caregiver distress, will be measured and~     compared between the groups.~   "
100743|NCT02248623|"~     A primary aim of anaesthesia is to prevent awareness of surgery; ablation of the experience~     of surgery is the most secure way to prevent awareness with recall. Fortunately the incidence~     of awareness with recall (the patient can spontaneously remember the intraoperative event) is~     very rare (0.1-0.2%). However the investigators systematic review suggests that consciousness~     of intraoperative events may occur in approximately 37% of patients in experimental studies~     (as identified by the validated clinical procedure the isolated forearm test that does not~     require postoperative recall of the event). In this international cohort study, recruiting a~     minimum sample of 200 patients, the investigators will investigate the incidence of~     anaesthesia awareness (as identified by the isolated forearm test) following the induction of~     anaesthesia and before surgery.~   "
100744|NCT02248610|"~     In patients with acute clots (deep vein thrombosis or pulmonary embolism) the investigators~     will collect real world data on their short and long term outcomes. The investigators~     hypothesise that in patients treated from the outset with rivaroxaban that: 1. treatment will~     be non-inferior to treatment with conventional anticoagulants (heparins and warfarin); 2.~     there will be less bleeding than when patients are on conventional anticoagulants; 3. there~     will be a lower long-term incidence of morbidity from chronic thromboembolic pulmonary~     hypertension and post-thrombotic limb syndrome.~   "
100745|NCT02248597|"~     This pilot clinical trial studies donor stem cell transplant followed by cyclophosphamide in~     treating patients with hematological diseases. Giving chemotherapy before a donor stem cell~     transplant helps stop the growth of cells in the bone marrow, including normal blood-forming~     cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused~     into the patient they may help the patient's bone marrow make stem cells, red blood cells,~     white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an~     immune response against the body's normal cells (called graft-versus-host disease). Giving~     cyclophosphamide after the transplant may stop this from happening.~   "
100746|NCT02248584|"~     The objective of this study was to evaluate the effects of supplementary antioxidant therapy~     on the levels of biomarkers and inflamatory citocines in patients with a previous history of~     non-melanoma skin cancer treated with surgery. This was a double-blind, randomized,~     placebo-controlled trial. Patients were randomized into two groups, one receiving placebo~     (n=34) and the other receiving supplementary antioxidant therapy (n=26) with vitamin C (50~     mg), vitamin E (60 mg), and zinc (40 mg) for 60 days. Blood samples were obtained from~     patients, and the levels of oxidative stress biomarkers, including 8-isoprostane, nitrite,~     thiobarbituric acid reactive substances, and total antioxidant capacity, were measured, as~     well as the inflamatory citocines (IL-1, IL-6, IL-10, TNF alfa) and it was evaluated at two~     different times: (1) one day before the start of supplementation or placebo administration~     and (2) at 60 days after intervention. Statistical analyses were performed with the SAS~     System for Windows 9.3 program and data were analyzed using ANOVA for repeated measures test.~   "
100747|NCT02248571|"~     This is a clinical trial with a crossover design to determine patients' preference for~     capecitabine in combination with bevacizumab or everolimus in combination with exemestane for~     advanced breast cancer patients and to evaluate, if any combination is associated with a~     better quality of life.~      To identify patients' preference for either therapy in this trial, patients without disease~     progression or other reasons for early discontinuation will be asked for their treatment~     preference and their treatment satisfaction. To correlate patients' preference with other~     patient reported outcomes (PROs), quality of life (QoL) will be assessed at baseline and~     throughout the study, using dedicated questionnaires.~      With similarly active treatment options, it is of utmost importance to identify the treatment~     that has the least negative impact on the patients' quality of life.~   "
100748|NCT02248558|"~     Crowdsourcing may be a powerful tool to spur the development of innovative videos to promote~     HIV testing among key populations such as men who have sex with men (MSM) and transgender~     (TG) individuals. The purpose of this randomized controlled trial is to compare the effect of~     a crowdsourced video and a conventional video on first-time HIV testing among MSM and TG in~     China. The crowdsourced video was developed using an open contest, formal transparent~     judging, and an incentive of marketing promotion. The hypothesis is that a crowdsourced video~     will be equivalent (within a margin of 3%) to a conventional video in terms of self-reported~     first-time HIV testing within 3-4 weeks of watching the video.~   "
100749|NCT02248545|"~     Celiac disease (CD) is an immune-based reaction to dietary gluten (storage protein for wheat,~     barley, and rye) that primarily affects the small intestine in genetically predisposed~     patients and resolves with exclusion of gluten from the diet. Patients with CD show~     circulating autoantibodies (anti-transglutaminase, anti-tTG) and suffer from the destruction~     of a specific tissue cell type (the enterocytes) by CD8+ T cells. Furthermore, other~     autoimmune diseases have been reported in association to CD in 20-30% of the cases. In the~     last few year, a new clinical entity emerged, which seems include patients who consider~     themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though~     they do not have CD or wheat allergy. This clinical condition has been named Non-Celiac~     Gluten Sensitivity (6), but, in a recent paper, the investigators suggested the term~     Non-Celiac Wheat Sensitivity (NCWS), since, to date, it is not known what component of~     wheat really causes the symptoms. The doubt areas about the NCWS regard also its pathogenesis~     as, despite some papers evidenced an intestinal immunologic activation, others excluded it.~     To explore the presence of autoimmunity in NCWS, the investigators evaluated: a) the~     frequency of autoimmune diseases and b) the frequency of serum anti-nuclear antibodies (ANA)~     positivity in newly diagnosed NCWS, compared to CD patients.~   "
100750|NCT02248532|"~     The goal of REMEDIUM project is to develop personalized stem cell therapy for patients with~     chronic heart failure due to dilated cardiomyopathy (DCM). The main focus of the project is~     (1) on repetitive administration of cell therapy that would allow for long-lasting~     improvements in heart function and outcome in this patient population. In parallel, the~     investigators aim to (2) develop a standardized patient-specific stem cell product that could~     be cryopreserved and stored in a stem cell bank for prolonged time periods, and used for~     therapeutic application when clinically indicated. By using a unique multimodality imaging~     platform, the goal of this project is also to (3) define standardized clinical criteria that~     would serve as a guideline for evaluation of the effects of stem cell therapy in future~     clinical trials and everyday clinical settings. Finally, to improve the clinical~     implementation of cell therapy,the investigators aim to (4) develop a stem cell delivery~     technique that could be used to treat both left and right and ventricular failure and could~     be implemented in a standardized fashion designed for a widespread clinical use.~   "
100751|NCT02248519|"~     This is the first randomized controlled trial comparing laparoscopic and open gastrectomy for~     resectable gastric cancer in a Western population. The hypothesis is that laparoscopic~     gastrectomy will result in a lower post-operative burden by means of shorter post-operative~     hospital stay. Secondarily that laparoscopic gastrectomy is hypothesized to be associated~     with lower post-operative morbidity and readmissions, higher cost-effectiveness, and better~     post-operative quality of life, with similar mortality and oncologic outcomes, compared to~     open gastrectomy. The study starts on 1 December 2014. Inclusion and follow-up will take~     three and five years respectively. Short-term results will be analyzed and published after~     discharge of the last randomized patient.~   "
100752|NCT02248506|"~     To determine proportion of women achieving clinical and mycological cure or have recurrences~     / reinfection after being treated for an acute episode of vulvovaginal candidiasis.~   "
100753|NCT02248493|"~     The purpose of this study is to define if intravenous paracetamol may improve analgesia and~     outcome in pediatric surgical patients treated with non-steroidal anti-inflammatory drugs~     (NSAIDs) postoperatively.~      Hypothesis: intravenous paracetamol in a dose 60 mg/kg/24 h IV, given in addition to IV~     ketoprofen (4,5 mg/kg/24h), improves analgesia and physical recovery in children and~     adolescents following surgery.~   "
100754|NCT02248480|"~     The main purpose of this study is to evaluate the efficacy of the study drug known as~     duloxetine in participants with chronic osteoarthritis (OA) and knee pain in Japan.~   "
100755|NCT02248467|"~     The primary purpose of the study is to evaluate, in obese and hypogonadal patients eligible~     for bariatric surgery, the effect of testosterone replacement therapy in improving lower~     urinary tract symptoms (LUTS) assessed using the IPSS (International Prostate Symptom Score)~     questionnaire, compared to hypogonadal untreated subjects and eugonadal subjects.~   "
100756|NCT02248454|"~     The purpose of this study is to evaluate an insulin bolus for use to cover higher fat meals.~      Subjects will have several admissions during which the investigators will apply an iterative~     dose escalation protocol to derive an optimized insulin bolus dose (carbohydrate-to-insulin~     ratio for fat to minimize postprandial hyperglycemia following higher fat meals. The~     investigators hypothesize that the incremental insulin dose required to cover dietary fat in~     patients with type 1 diabetes will be related to total daily insulin dose (U/kg).~   "
100757|NCT02248441|"~     The present study will evaluate whether treatment with daily remote ischemic conditioning for~     a 28±4-day period induces beneficial effects in subjects with and without chronic ischemic~     heart failure in terms of improved left ventricular contractile function and exercise~     capacity.~   "
100758|NCT02248428|"~     Due to economic reasons, thalidomide is still widely used as a first line drug for Multiple~     Myeloma patients in China. However,the efficacy of CTd is still lower than the therapeutic~     regimens with new drugs. Clarithromycin may have partly efficacy in association with steroids~     and thalidomide for Multiple Myeloma patients. This multicenter, randomized, phase 3 clinical~     trial is proposed to explore whether clarithromycin could potentiate responsiveness of CTd~     (Cyclophosphamide, Thalidomide and Dexamethasone) regimen in Newly Diagnosed Multiple Myeloma~     patients. The trial will also evaluate the side effects caused by the combination of these~     drugs.~   "
100759|NCT02248415|"~     The aim of this study is to compare the effect of warm blood cardioplegia administration with~     and without roller pump on perioperative myocardial injury, reflected by postoperative~     biomarker release, in patients undergoing coronary artery bypass grafting (CABG) with a~     minimal extracorporeal circuit (MECC).~   "
100760|NCT02248402|"~     Multiple myeloma remains incurable disease in most patients . Cellular immunotherapy using~     dendritic cells is emerging as a useful immunotherapeutic modality to treat multiple myeloma.~     Vax-DC/MM is an potent immunotherapeutic agent generated by dendritic cells loaded with the~     ultraviolet B-irradiated autologous human myeloma cells. The main purpose of this study is to~     examine the safety and efficacy of Vax-DC/MM in patients with relapsed or refractory multiple~     myeloma.~   "
100806|NCT02247804|"~     This study will evaluate the efficacy and safety of bimatoprost sustained-release (SR) in~     patients with open-angle glaucoma or ocular hypertension. The study includes a 12-month~     treatment period with an 8-month extended follow-up.~   "
100761|NCT02248389|"~     The Sonatherm device provides both advanced imaging (ultrasound guidance) and high intensity~     focused ultrasound to target and ablate tumors. It also does not require piercing the tumor~     with a needle as does cryotherapy (Cryo) and radiofrequency (RF) ablation. Cryo and RF also~     have high retreatment rates due the finding of untreated tumor on follow-up imaging. Thus,~     there is reason to hypothesize that Sonatherm with it's real-time ultrasound imaging feedback~     could replace RF and Cryo for the treatment of small renal masses where the invasiveness of~     full resection partial nephrectomy is contraindicated due to patient comorbidities.~   "
100762|NCT02248376|"~     The primary purpose of the study is to compare efficiency of a non-stick gel application~     after scraping surgery for natural miscarriage with no non-stick gel application after~     scraping surgery.~      Post-scraping uterine synechiae rate will be established at the diagnostical hysteroscopy 6-8~     weeks after surgery.~   "
100763|NCT02248363|"~     Chronic pain is a common health problem that causes enormous social costs. A common method~     for treating patients with chronic pain problems are multimodal rehabilitation (MMR), which~     consists of a combination of physical exercise, cognitive behavioural therapy and work~     training coordinated in an interdisciplinary team. Our research aims to evaluate the~     effectiveness of MMR on health, quality of life, physical activity, return to work and health~     economics, with the long-term goal of developing MMR. We aim also to evaluate predictive~     factors for good and bad treatment outcomes in order to better adapt the MMR to the patient.~     The project is based on patient-reported data from the Swedish Quality Registry for Pain~     Rehabilitation, which routinely collects data from 40 (2017) Swedish specialist MMR clinics~     from all parts of the country. We expect increased knowledge of treatment effects and how MMR~     can be effectively adapted according to the patient's limitations and resources. Our project~     group is interdisciplinary and is active in nationwide research networks that focus on~     chronic pain and rehabilitation.~   "
100764|NCT02248350|"~     This main purpose of this study is to examine the effects of an exercise intervention to~     counteract adverse side effects related to Androgen Deprivation Therapy (ADT) in prostate~     cancer patients. Specifically, a supervised and home-based exercise program will be used to~     assess its impact on clinical and behavioral variables related to ADT in prostate cancer~     patients.~   "
100765|NCT02248337|"~     Comparison of two PEG-based bowel cleansing regimens in patients with inflammatory bowel~     disease.~   "
100766|NCT02248324|"~     The purpose of this study is to determine whether common genetic polymorphisms that have been~     verified to be related to age-related macular degeneration (AMD) in some populations are also~     associated with AMD in Turkish population~   "
100767|NCT02248311|"~     Current methods based on traditional Cardiovascular risk factors are not clinically useful~     for identifying Type 2 Diabetes patients at risk of developing acute Cardiovascular ischemic~     events (ie.myocardial infarction or stroke). In addition, Cardiovascular ischemic events in~     Type 2 Diabetes population have worse prognosis than in general population. In fact, there is~     sufficient experimental evidence indicating that diabetes exaggerates the deleterious effects~     of ischemic events and worsens their outcome.~      A prolonged sub-clinical phase exists before a Cardiovascular event occurs in Type 2 Diabetes~     patients. Therefore, new strategies aimed at identifying those patients with this subclinical~     Cardiovascular Diabetes and, consequently, more prone to develop Cardiovascular events is a~     challenge to be met.~   "
100768|NCT02248298|"~     Photodynamic therapy (PDT) using methyl aminolevulinate (MAL) is an effective first-line~     treatment for actinic keratosis (AK). Erbium: yttrium-aluminium-garnet (Er:YAG) ablative~     fractional laser-assisted MAL-PDT (AFL-PDT) has shown significant benefit for the treatment~     of AK. However, knowledge on the optimal photosensitizer incubation time for AFL-PDT is~     limited~   "
100769|NCT02248285|"~     BioFire Diagnostics, LLC (BioFire) has developed the FilmArray Gastrointestinal (GI) Panel, a~     rapid, easy to use PCR-based in vitro diagnostic test for the identification of 22 common~     microorganisms responsible for infectious gastroenteritis (http://filmarray.com/the-panels/)~     from a stool specimen collected in Cary Blair enteric transport media. The test was made~     available for sale in the US and EU following FDA clearance and CE marking in May, 2014.~      The FilmArray GI Panel offers improvements over conventional laboratory testing which~     include: reduced turnaround time from specimen to result, reduced laboratory labor costs,~     increased sensitivity and specificity relative to current clinical reference methods, and~     larger breadth of organism identification than is available using standard methods. Because~     of these attributes, the results from this test have the potential to enable clinicians to~     more accurately diagnose and treat GI illness in a reduced time frame.~      Collaborators at the University of Utah, Brown University/Lifespan, and BioFire Diagnostics~     have designed a study to evaluate health outcomes of pediatric subjects presenting to~     emergency departments with GI illness before and after establishing the FilmArray GI Panel as~     the standard of care method for stool pathogen analysis. It is hypothesized that the rapid (~~     1 hour turnaround time), sensitive, specific, and comprehensive results provided by the~     FilmArray GI Panel will allow clinicians to more rapidly diagnose GI illness, initiate~     appropriate therapy and provide guidance when compared to the pre-implementation period.~   "
100770|NCT02248272|"~     This study investigated any potential associations between two isocaloric diets with~     different meal frequency (3 meals versus 6 meals) and glycemic control in people at high~     diabetes risk (lean and overweight/obese women with PCOS, individuals with hyperinsulinemia,~     individuals with impaired glucose tolerance) and diagnosed with diabetes.~   "
100771|NCT02248259|"~     The objective of the current study is to evaluate the effect of once daily itraconazole on~     the pharmacokinetics of BI 409306 in poor (PM) and extensive metabolisers (EM) of CYP2C19.~   "
100772|NCT02248246|"~     This is a prospective, non-randomized, single arm, multicenter, observational study to assess~     the initial clinical experience with the Harmonic ACE®+7 Shears by evaluating vessel sealing~     during laparoscopic colectomy. The study will not modify or influence current surgeon~     technique. Investigators will perform each procedure using the device in compliance with~     their standard surgical approach and product labeling.~      The Harmonic ACE®+7 Shears is cleared for commercial distribution and will be used in~     accordance with approved product labeling. The Harmonic ACE®+7 Shears will be assembled,~     calibrated, and/or used in accordance with manufacturer design specifications, product~     instructions and guidelines.~   "
109797|NCT02130271|"~     The purpose of this study is to see if the spine shows areas of inflammation using a specific~     type of imaging (pictures).~   "
100773|NCT02248233|"~     Massive cerebral infarction is an ischemic stroke caused by complete blockage of the internal~     carotid artery, middle cerebral artery, or their cortical branches. The widespread~     infarction, pathological severity and high fatality rate associated with massive cerebral~     infarction pose a major threat to affected patients. However, there is a lack of unified~     diagnostic criteria. Many researchers use Adams' classification, in which massive cerebral~     infarction is diagnosed when the following criteria are met: infarct size > 13 cm2; a major~     brain-feeding artery is involved; the focal site affects more than two cerebral lobes;~     infarct diameter line ≥ 3 cm in internal capsule of striatum.~      Prolonged cerebral ischemia/reperfusion can induce complex secondary changes in brain tissue,~     so the use of neuroprotective agents is very important. Remarkable progress has been made~     over the last decade in understanding the protective effect of calcium antagonists against~     cerebral ischemia. In particular, the liposoluble dihydropyridine Ca2+ antagonist nimodipine~     selectively acts on cerebral vessels and neurons and can protect ischemic brain tissue,~     providing a new way of treating ischemic cerebrovascular disease.~      Preclinical and clinical tests have shown that nimodipine has a protective effect on ischemic~     brain tissue, and indicate that patients should take the drug as soon as possible. However,~     there are no reports of double-blind, randomized, controlled clinical trials addressing the~     administration of nimodipine via intravenous drip within the time window for successful~     treatment of acute massive cerebral infarction.~   "
100774|NCT02248220|"~     Assessment of daily maintenance dose of Sifrol®, L-dopa sparing effect, effect on tremor,~     depression, anhedonia and tolerability~   "
100775|NCT02248207|"~     Study to obtain information about the co-operation of the different physician-colleagues in~     the treatment of patients with Parkinson's disease, both in private practices and clinics and~     about the primary treatment strategies in the pharmacotherapy of Parkinson's disease and to~     collect data on the tolerability of Sifrol® in ambulatory patients suffering from Parkinson's~     disease under routing conditions~   "
100776|NCT02248194|"~     Abnormal uterine bleeding (AUB) is any alteration in the pattern or volume of menstrual blood~     ﬂow and heavy menstrual bleeding affects up to 30% of women at some time during their~     reproductive years. Abnormal menstruation can be due to conditions such as pregnancy~     complication uterine fibroids and adenomyosis, but in a large proportion of cases, the~     etiology is unclear, a condition generally referred to as dysfunctional uterine bleeding~     (DUB). Treatment options for DUB include symptomatic medical treatment or surgery,~     traditionally hysterectomy.~      Hysteroscopically guided endometrial ablation methods have been shown to be effective and~     safe alternatives to hysterectomy for management of DUB. These methods require particular~     skills and experience and a long learning curve to be performed effectively and safely.~      Through the past three decades DUB patients in Assiut university hospital were treated with~     either electrosurgical ablation or hysterectomy. When faced with hysteroscopic challenges~     during transcervical resection of the endometrium or rollerball coagulation, we used to shift~     to thermal balloon as backup method . However, expensive uterine balloon could not~     infrequently be afforded because of financial constrains and limited health resources .~     Therefore, another method was used as backup for hysteroscopic failures. It was first tried~     via insulating the conventional double-ended uterine curette then through a specially~     designed tactile electrosurgical ablation (TEA) probe.The technique of TEA is largely similar~     to the dilatation and curettage procedure both principally and practically. Hence, the basic~     requirements for its performance are the general awareness with electrosurgical principles~     and adequate experience in performing dilatation and curettage. TEA is done by specially~     designed tactile diathermy probe that carried the job of electrosurgical ablation without~     hysteroscopy or distension media first in an experimental session that clearly clarified the~     reproducibility of the depth of thermal damage and safety of the tactile electrosurgical~     ablator . Thereafter, TEA was successfully performed with satisfactory short and medium term~     outcomes for ten cases with DUB during an active, relentless bleeding attack. TEA is done~     under laparoscopic monitoring.~      The aim of the present work is to present TEA as a simple, inexpensive, novel backup approach~     for treatment of DUB.~   "
100777|NCT02248181|"~     Study to document pramipexole dosing during monotherapy, occurrence of fluctuations and~     dyskinesias, dose increases after deterioration of Parkinson's disease (PD) symptoms,~     assessment of the reasons for add-on treatment with L-Dopa and dosing of pramipexole and~     L-Dopa when given concomitantly.~   "
100778|NCT02248168|"~     The objectives of this study are to investigate issues or questions about MIRAPEX Tablets as~     shown below through the Post Marketing Surveillance (PMS) study upon approval.~        -  Unexpected adverse events (especially, serious adverse events (SAEs))~        -  To find out the status of incidence of adverse events under actual practice~        -  Factors on the safety profile~        -  Factors on the efficacy profile~   "
100779|NCT02248155|"~     The objectives of this Post Marketing Surveillance (PMS) are:~        -  Evaluation of the treatment effect of pramipexole on Restless Legs Syndrome (RLS)~          severity as measured by International Restless Legs Syndrome Scale (IRLS) and Clinical~          Global Impression Improvement scale (CGI- I)~        -  Evaluation of the time to reaching maintenance dose of pramipexole~        -  Evaluation of work productivity impairment associated with RLS based on the Work~          Productivity and Activity Impairment Questionnaire (WPAI) questionnaire~   "
100780|NCT02248142|"~     Study to evaluate treatment effect of pramipexole on RLS severity as measured by IRLS, CGI-I~     and RLS-6 and to evaluate the time needed to reach maintenance dose of Pramipexole (PPX)~   "
100781|NCT02248129|"~     Study to compare the level of blood pressure control in hypertensive, hypertensive diabetics~     and hypertensive with renal insufficiency (observed data) in the study population, with the~     objectives of the High Authority for Health recommendations (benchmark)~   "
100782|NCT02248116|"~     Safety and tolerability. Quality of life (EQ-5D, ACQLI) and health economic impact (health~     resource utilisation, living and employment status) assessments, will not be performed at the~     centers in the united kingdom (UK)~   "
100783|NCT02248103|"~     A clinical and radiographic evaluation of autogenous periosteal pedicle graft in comparison~     with collagen membrane for management of periodontal intrabony defects.~   "
100784|NCT02248090|"~     This is a phase 1 open label multicentre study of AZD9496 administered orally in patients~     with advanced ER+ HER2 negative breast cancer. The study design allows an escalation of dose~     with intensive safety monitoring to ensure the safety of patients. The study will determine~     the maximum tolerated dose. In addition, expansion cohort(s) at potential therapeutic dose(s)~     in patients with or without ESR1 mutations will be enrolled to further determine the safety,~     tolerability, pharmacokinetics and biological activity of AZD9496~   "
100785|NCT02248077|"~     This study is designed to demonstrate the outcome of complete ulcer closure of patients with~     Wagner Grade 1-4 DFUs, VLUs or Stage II-IV PUs using AutoloGel versus Usual and Customary~     Care (UCC).~   "
100807|NCT02247791|"~     The purpose of this study is to evaluate whether an uncemented hip prosthesis is as safe as~     an cemented hip prosthesis for patients undergoing total hip arthroplasty surgery following a~     displaced femoral neck fracture.~   "
100786|NCT02248064|"~     Long term oxygen therapy (LTOT) increases the life span of patients with chronic obstructive~     pulmonary disease who have low oxygen levels. However, even when on oxygen therapy at home,~     from time to time patients still have low oxygen levels especially when walking which can be~     harmful.~      The investigators have designed a new system of delivering oxygen to overcome the above~     problem. The system measures the oxygen saturations of a patient and subsequently adjust the~     flow of oxygen to meet a pre-set oxygen saturation target.~      Hypothesis: the investigators intelligent oxygen therapy system is better at reducing low~     levels of oxygen during a 6 minute walk than usual ambulatory oxygen for patients with~     chronic obstructive pulmonary disease and idiopathic pulmonary fibrosis.~   "
100787|NCT02248051|"~     The main purpose of this trial is to demonstrate the safety, tolerability and~     pharmacokinetics (PK) of CXA-10, at potentially therapeutic doses, in the target patient~     population comprised of subjects with Stage 3 and 4 chronic kidney injury (CKI). In addition,~     associated pharmacodynamic (PD) effects of CXA-10 will be investigated.~   "
100788|NCT02248038|"~     The purpose of this study is to verify the 5-year disease free survival (DFS) of resectable~     colorectal cancer after laparoscopic surgery according to a Chinese Operative Standard was~     not inferior to open surgery.~   "
100789|NCT02248025|"~     Fluid responsiveness in a context of circulatory failure can be assessed by different way.~     Microcirculatory evaluation to assess fluid responsiveness could be interesting, but the~     available device are expensive and the analysis are delayed. Capillary refill time (CRT) is~     hampered by its variability. The investigators have developed a method to standardize the~     pressure, the length of compression and a computerized analysis to calculate the capillary~     refill time. This method enables accurate measure of CRT.~      The investigators will study if CRT variation induced by a passive leg raising (PLR) can~     predict CRT after a 500 ml Fluid Load.~      About thirty patients in circulatory failure with a continuous cardiac output monitoring for~     whom, the attending physician has decided a fluid load, will be included. hemodynamic~     parameters (arterial pressure, venous pressure, cardiac output), metabolic parameters~     (arterial and venous blood gas and lactate), microcirculatory parameters (assessed by~     sublingual video-microscopy) and capillary refill time measured on the thorax and on the~     gingival area will be recorded. Data collection will be made before and after a passive leg~     raising and after a 500 ml fluid load of crystalloids.~      Patients will be aposteriori sorted in two groups: responders and non responders, defined by~     the reduction of CRT after the fluid load. The diagnosis ability of the CRT variation after~     PLR to predict in which group each patient is classified will be investigate and receiver~     operative characteristic curve will be built. These results will be compared to the metabolic~     response, the macrocirculatory response, and the microcirculatory response.~   "
100790|NCT02248012|"~     To study the efficacy of everolimus combined with temozolomide as first-line treatment in~     advanced gastroenteropancreatic neuroendocrine carcinoma with a Ki67 of 20-55%, measured as~     disease control rate (non-progressive disease) at 6 months.~   "
100791|NCT02247999|"~     Background:~        -  Cervical cancer is a major cause of cancer deaths among women. Most cases of cervical~          cancer are caused by the human papillomavirus (HPV). HPV is more common in women who~          have the human immunodeficiency virus (HIV). India has one of the highest rates of women~          who have both cervical cancer and HIV infection.~        -  Cervical cancer can be discovered in early stages by screening for HPV infection.~          Researchers want to compare new cervical cancer screening tests for HIV-infected women.~          They also want to know more about how HPV can lead to cervical cancer in HIV-infected~          women. To do so, they will hold a study to screen HIV-infected women in India.~      Objectives:~      - To improve cervical cancer screening methods in HIV-infected women in India.~      Eligibility:~        -  Women at least 18 years of age who have HIV infection.~        -  Participants will be recruited from HIV-focused health care clinics in Pune and Chennai,~          India.~      Design:~        -  Participants will have a physical exam and medical history. They will provide a urine~          sample and proof of HIV infection.~        -  Participants will have a gynecological exam. This will involve a pelvic exam and Pap~          smear to collect cells for study. It will also involve a cervical exam to look for~          precancerous cells. Cervical tissue may be collected.~        -  Participants will also provide a blood sample for testing.~        -  Participants will return in 2 weeks for the test results. If there are signs of~          precancerous or cancer cells, participants will be referred to a doctor for treatment.~   "
100792|NCT02247986|"~     Background:~      - Disruptive behavior is a common problem for children and adolescents. It can be treated~     with some success with stimulant medicine. Researchers want to learn more about how this~     works.~      Objective:~      - To learn how the brain changes when taking the medicine methylphenidate for behavior~     problems.~      Eligibility:~        -  Children ages 10 17 with conduct disorder and/or attention deficit disorder.~        -  Healthy volunteers the same age.~      Design:~        -  Participants will be screened under a separate protocol.~        -  Participants will have two 3-hour sessions at the clinic. Girls who are menstruating~          will have a pregnancy test before their scans.~        -  Visit 1: All participants will:~        -  Perform simple tests on a computer.~        -  Fill out a questionnaire along with their parent or guardian.~        -  Have an MRI scan. A magnetic field and radio waves take pictures of the brain.~          Participants will lie on a table that slides into a metal cylinder. A coil will be~          placed over their head. They will be in the scanner for 60 minutes, lying still or~          performing a simple task. They will practice the task before the scan. A computer screen~          will show them task information during the scan. The scanner makes loud knocking sounds.~          Participants will get earplugs. Their parent or guardian can stay with them during the~          scan.~        -  Only participants with behavior disorders will:~        -  Take a pill of the study medicine or placebo.~        -  Be monitored for any side effects.~        -  Visit 2 is a repeat of Visit 1, except participants who got a pill in Visit 1 will get~          the other pill in Visit 2. For healthy volunteers, the 2 visits are exactly the same.~   "
100793|NCT02247973|"~     The study is a phase II trial designed to evaluate the efficacy and safety of~     co-transplantation with bone marrow derived mesenchymal stem cells from related donors in~     alternative donor transplantation of severe aplastic anemia.~   "
100850|NCT02247232|"~     This study is a phase III, multicenter, double-blind, placebo-controlled, parallel group~     comparative study to evaluate the efficacy and safety of Z-100 with primary uterine cervical~     cancer on radiotherapy. The study will use a central randomization with a dynamic allocation~     using biased coin minimization.~   "
100794|NCT02247960|"~     The aim of this study is to determine whether antibiotics prophylaxis at the time of urinary~     catheter removal decreases the number of symptomatic urinary tract infections in patients~     after radical prostatectomy. In addition, the investigators aim to determine whether~     antibiotic prophylaxis is potentially harmful to patients (e.g. adverse reactions from~     antibiotic use, resistant bacteria in the urine, Clostridium difficile infections etc.). The~     investigators also aim to identify specific populations that may be at higher risk of~     developing urinary tract infections with urinary catheter use after radical prostatectomy.~   "
100795|NCT02247947|"~     Proteomics is used to identify prognostic markers after CPR. Additionally neurological~     outcome should be estimated by specific protein alterations and affections of pathways.~   "
100796|NCT02247934|"~     The objectives of this qualitative study are to elicit concepts about symptoms that are~     important to patients with primary sclerosing cholangitis (PSC), as well as the key impacts~     of symptoms on patients' day-to-day functioning.~   "
100797|NCT02247921|"~     Stroke is the second leading cause of mortality and disability among adults worldwide.~     Rehabilitation is an effective treatment for stroke; however rehabilitation services are far~     from adequate in China, especially in rural areas where the health and economic burden of~     disability from stroke is very high.~      The investigators propose to develop, implement, and evaluate an evidence-based~     caregiver-delivered stroke rehabilitation program designed to improve the physical~     functioning of disabled stroke patients in rural China.~   "
100798|NCT02247908|"~     The purpose of this randomized controlled trial is to determine whether graphic health~     warnings on cigarette packs are more effective than the existing Surgeon General's warning on~     cigarette packs at encouraging quit attempts. While previous experiments evaluating candidate~     graphic warnings have been informative, they have used psychological outcomes, such as~     attitudes or quit intentions, but not actual cessation behavior (e.g., quit attempts).~     Furthermore, they typically expose participants to warnings in controlled but artificial~     experimental settings for a short period of time, using much lower frequency and shorter~     duration of warning exposure than found in the real world. This study addresses these issues~     by evaluating the impact of warnings on quit attempts by randomly assigning smokers to have~     their cigarette packs labeled with either a graphic warning or a Surgeon General's warning~     for four weeks.~      Main hypothesis: Smokers randomized to receive graphic warnings on their cigarette packs will~     be more likely to report a quit attempt in the 4 weeks of the study than smokers randomized~     to receive a Surgeon General's label on their cigarette packs.~      Secondary hypothesis: Smokers randomized to receive graphic warnings on their cigarette packs~     will have higher quit intentions at 4 weeks than smokers randomized to receive a Surgeon~     General's label on their cigarette packs, controlling for baseline quit intentions.~   "
100799|NCT02247895|"~     Patients who are admitted to the intensive care unit and require mechanical ventilation~     frequently develop profound respiratory and limb muscle weakness. Studies show that the~     development of weakness during the ICU stay results in poor outcomes. Currently there are no~     treatments for this muscle weakness, but it has been suggested that this weakness might~     improve with physical therapy. Electrical stimulation is a method to provide direct~     stimulation to the muscles potentially enhancing function and improving strength. The purpose~     of this study is to test the hypothesis that neuromuscular electrical stimulation of the~     quadriceps muscle will improve muscle strength in patients who are critically ill on~     mechanical ventilation.~   "
100800|NCT02247882|"~     The purpose of this study is to determine whether education or aquatic physical therapy are~     effective in the treatment of osteoarthritis in Knee due to intensity of pain, function~     capacity, quality of life and kinetic.~   "
100801|NCT02247869|"~     Prospective, multicenter, Phase II trial designed to assess whether intensification of ABVD~     (dd-ABVD) is feasible and can improve the outcome of patients with early stage Hodgkin~     Lymphoma.~   "
100802|NCT02247856|"~     Background: Beneficial effects from noninvasive ventilation (NIV) in acute COPD are~     well-established, but couple to nebulization is still challenging. Aim: To compare~     radioaerosol pulmonary deposition and radioaerosol mass balance in the different compartments~     (pulmonary and extrapulmonary) using vibrating mesh nebulizer (VMN) and jet nebulizer (JN)~     coupled to NIV.Methods: It was a crossover study involving 9 stable moderate to severe COPD~     randomly allocated for both phases of the study: Phase 1(NIV+MN,n=9) and phase 2(NIV+JN,n=9).~     Bronchodilators were delivered during NIV using a facemask (pressures of 12 cmH2O and 5 cmH2O~     - inspiratory and expiratory, respectively). Radioactivity counts were performed using a~     gamma camera and regions of interest(ROIs) were delimited. We determine aerosol mass balance~     from the lungs, upper airways, stomach, nebulizer, circuit, inspiratory and expiratory~     filters, and mask as a percentage.~   "
100803|NCT02247843|"~     This Phase I clinical trial will assess the safety and initial evidence for efficacy of an~     autologous transplant of lentiviral vector modified bone marrow for adults with severe sickle~     cell disease.~   "
100804|NCT02247830|"~     It aims to evaluate the efficacy of the chamomile recutita gel and urea cream in the~     prevention of radiodermatitis in patients with breast cancer or head and neck cancer~     undergoing radiotherapy.~      Prophylactic Trial will consist of a control group and two experimental groups, namely~     control group (usual care), Experimental Group 01 (usual care + topical application of the~     gel C. recutita) and Experimental Group 02 (usual care + topical application of Urea based~     cream).~      The doses used in the different compounds are being in test since february 2014 by a~     dose-response curve study, using 6 groups with three doses of urea cream and three doses of~     C. recutita gel.~      The study will be conducted at the Center for High Complexity Oncology at University Hospital~     of Brasília (CACON/HUB), Brazil. The degree of radiodermatitis is evaluated weekly, according~     to established criteria to classify the effects of radiotherapy, which identifies grades 0,~     1, 2 , 3 and 4, according to the score of the Radiation Therapy Oncology Group - RTOG. To~     evaluate the skin reaction will also be applied scale Common Terminology Criteria for Adverse~     Events (CTCAE) and Radiation-Induced Skin Reaction Assessment Scale (RISRAS).~   "
100872|NCT02246946|"~     The purpose of this study is to determine if the addition of intermittent positive airway~     pressure breathing (specific lung expansion technique) to conventional chest physiotherapy~     chest drainage is effective to accelerate the reabsorption of pleural effusion and~     consequently decrease the duration of chest tube drainage and respiratory system impairment.~     These effects would decrease hospital stay lengths and the incidence of pulmonary~     complications.~   "
100808|NCT02247778|"~     Surgical incision for plate osteosynthesis of midshaft fractures of the clavicle averages 7~     to 8 centimeters in the literature. It is hypothesized, that depending on the invasiveness of~     this incision secondary problems like prolonged fracture healing, paresthesia of~     supraclavicular nerves and pain due to scar tissue increase. Therefore we developed a~     mini-incision technique using an average incision length of 4cm.~      The aim of this study is to analyzed whether secondary problems following plate~     osteosynthesis of the clavicle correlate mit the length of the surgical access.~   "
100809|NCT02247765|"~     To validate the proposed claims for pulse rate and saturation accuracy in a diverse subject~     population during motion over a specified saturation range.~   "
100810|NCT02247752|"~     The definition of HBs antigen (HBsAg) inactive carrier status has evolved during time. We~     spoke first from HBsAg healthy carrier , then from  asymptomatic carrier , last from~     HBsAg inactive carrier . This definition continue to be not totally consensual. A very low~     viral load (< 2000 UI/ml) or undetectable, associated with repetitive normal transaminases~     and with detectable anti-HBe antibodies were necessary to affirm the inactive carrier status~     on 2009 EASL recommendations. The 2012 EASL recommendations confirm that the normality of~     alanine aminotransferase (ALT) with an upper limit of normal (ULN) approximately below 40~     UI/ml, like low viral load (HBV-DNA), does necessary be verified every 3 or 4 months during a~     year to diagnose an inactive carrier. Nevertheless, they admit the possibility for some~     patients to be inactive carriers with HBV-DNA between 2000 and 20000 UI/ml with consistently~     normal transaminases This study will follow-up HBsAg inactive carriers during 5 years, in~     order to evaluate the incidence of unfavourable liver events: chronic hepatits B, liver~     cirrhosis, hepatocarcinoma (CHC) during this time, and to determine the independant prognosis~     criteria of unexpected arrival of such events. Secondary outcomes will evaluate HBsAg~     quantification for the prognosis of such events or, in contrary HBs seroconversion; will~     evaluate the influence of B genotype on HBsAg level; will evaluate the influence of~     comorbidities on unexpected arrival of such events.~   "
100811|NCT02247739|"~     Primary Objective:~      To evaluate the efficacy of recombinant human C1 inhibitor (rhC1INH) in the prophylaxis of~     angioedema attacks in patients with HAE~      Secondary Objective:~      To evaluate the safety and immunogenicity of recombinant human C1 inhibitor (rhC1INH) in the~     prophylaxis of angioedema attacks in patients with HAE~   "
100812|NCT02247726|"~     The purpose of this study is to evaluate the safety and immunogenicity of an RSV-F protein~     nanoparticle vaccine, with aluminum, in healthy third-trimester pregnant women and to assess~     the impact of maternal immunization on infant safety through one year of life.~   "
100813|NCT02247713|"~     A part retrospective, part prospective cohort study to assess the difference in 2-year~     overall survival in patients with stage III NSCLC receiving chemoradiotherapy with curative~     intent in low and middle income countries before and after a training intervention on the use~     of PET/CT for radiotherapy treatment planning.~   "
100814|NCT02247700|"~     Respiratory disorders are the leading cause of respiratory failure in children. Thousands of~     children are admitted to a pediatric intensive care unit each year and placed on mechanical~     ventilators. Despite over 40 years since the first pediatric-specific ventilator was~     designed, there has been no specific cardiopulmonary directed therapy that has proven~     superior. While mechanical ventilation is generally lifesaving, it can be associated with~     adverse events. There is evidence building to suggest that adopting a lung protective~     ventilation strategy by the avoidance of lung over-distension and collapse reduces death.~     Therefore, timely discovery of these two lung conditions is extremely important in order to~     mitigate the effects associated with positive pressure mechanical ventilation. The~     investigators research team has extensive research experience with a non-invasive and~     radiation free medical device called electrical impendence tomography (EIT). EIT is intended~     to generate regional information of changes in ventilation. Meaning it can detect this~     collapse and overdistension. This additional source of information could help fine tune the~     mechanical ventilator. A baseline of understanding of how often this occurs in the patients~     the investigators serve is required. Therefore the investigators propose an EIT observation~     study in their pediatric ICU patient population.~   "
100815|NCT02247687|"~     Management of participants with low-level persistent viremia~   "
100816|NCT02247674|"~     The investigators hypothesized that bilateral handgrip force training would result in~     significant improvements in paretic hand, arm movements and daily functional performances. In~     order to investigate whether the improvement of paretic hand could facilitate the motor~     recovery of paretic arm and functional performances, the investigators also hypothesized that~     motor recovery and functional performances improvements of paretic arm and hand have strongly~     correlation.~   "
100817|NCT02247661|"~     A prospective cohort study to compare the direct lateral and poster-lateral approach~     concerning abductor function. Patients admitted with a femoral neck fracture operated with a~     hemiarthroplasty through a direct lateral or a poster-lateral approach were screened for~     inclusion. Patients with altered mental status SPMSQ >7, pathological fractures, non-walkers~     were excluded.~      Those who fulfilled the inclusion criteria and non of the exclusion criteria were followed 1~     year postoperatively by clinical examination. Sample size were estimated to 30 patient in~     each group. Primary outcome variables were trendelenburg test, abductor strength measured~     with dynamometry, trochanteric tenderness measured with algometry and palptation.~   "
100818|NCT02247648|"~     The investigators hypothesize that the use of tramadol will reduce pain and analgesic~     consumption after arthroscopic shoulder surgery.~   "
100860|NCT02247102|"~     The study shall investigate whether isomaltulose~        -  is digested and absorbed to a comparable degree like other carbohydrates (CHO) used as~          ingredients for this age group (e.g. sucrose), by measuring the H2 exhalation in the~          postprandial period~        -  does not mediate abdominal discomfort or diarrhoea and is therefore as well tolerated as~          other CHO (e.g. sucrose), by/in healthy infants aged 6 to 12 months.~      It is hypothesized that isomaltulose, provided with a standard follow-on formula,~        1. will not significantly increase the mean basal breath H2-excretion rate (determined as~          the incremental area under the curve (iAUC) of H2-exhalation) over a 3 h postprandial~          period compared to a sucrose containing standard follow-on formula.~        2. will not lead to a significantly different gastrointestinal tolerance in the conse-quent~          24 h after formula consumption compared to a sucrose containing standard follow-on~          formula in infants aged 6 to 12 months.~   "
100819|NCT02247635|"~     The metabolic syndrome is a group of cardiometabolic risk factors that reflect a sedentary~     lifestyle and the excessive intake of food among the risk factors that comprise it are~     located the obesity, hyperglycemia, dyslipidemia and hypertension.~      It has been observed that the interventions of lifestyle changes that promote weight loss~     through the practice of physical activity and intake of a hypocaloric diet, reduce the~     prevalence of chronic diseases such as Metabolic syndrome.~      Adherence is defined as the extent to which a person's behaviour - taking medication,~     following a diet, and/or executing lifestyle changes, corresponds with agreed recommendations~     from a health care provider. The World Health Organization has estimated that in developing~     countries, as in Mexico, less than 27% of people with chronic diseases will continue~     treatment as directed.~      Adherence to treatment of chronic disease is a multifactorial problem that includes not only~     patient-related barriers, but also providers of health services and social security systems~     themselves. Furthermore, as WHO has pointed out, as increasing prevalence of chronic~     non-adherence to treatment will become a global problem even more serious.~      The purpose of this study is develop and implement a methodology to overcome barriers~     affecting adherence to treatment of women over 20 years with non-communicable diseases such~     as metabolic syndrome (diabetes , hypertension and dyslipidemia) evaluating its impact~     through various quantitative indicators such as weight loss or metabolic syndrome prevalence.~      This study will include two phases:~        1. Phase 1. Design. Qualitative methodology was used primarily to identify the barriers~          faced by individuals to adhere to treatment. From this methodology, we developed a tool~          to assess adherence to treatment of subjects with these conditions and then an~          intervention to improve it.~        2. Phase 2. Implementation of intervention (24 weeks). To recruite a group of 180~          overweight and two of the following comorbidities: diabetes mellitus, dyslipidemia or~          hypertension. All study subjects will be randomized to a control group and intervention.~          The control group will receive a medical traditional clinical care. The intervention~          group will receive a lifestyle treatment with behavioral intervention to improve~          adherence for improve eating behaviors, physical activity and metabolic control.~   "
100820|NCT02247622|"~     PSC is a chronic cholestatic disorder. The investigators intend to study some telomere~     parameters and telomere length in order to predict a premalignant state.~   "
100821|NCT02247609|"~     Currently, a majority of B cell lymphomas cannot be cured by standard chemo-radiotherapy.~     Most B cell lymphomas express cluster of differentiation antigen 19 (CD19), which represents~     a very attractive target for chimeric antigen receptor (CAR)-based immune cell therapy. This~     study will evaluate a novel 4th generation CD19 CAR engineered with a self-withdrawal~     mechanism (19273-4SCAR) for both efficacy and safety in lymphoma patients.~   "
100822|NCT02247596|"~     The primary aim of our study was to examine the effects of two weeks of oral resveratrol on~     resting energy expenditure and insulin sensitivity in non-diabetic obese male subjects.~     Secondary variables included plasma lipid subfraction, blood pressure and glycated hemoglobin~     (HbA1c).~   "
100823|NCT02247583|"~     Prospective non-interventional non-controlled multicenter observational study to evaluate~     aspects of pharmaceutical care in patients with advanced renal cell carcinoma treated with an~     oral anti-cancer drug.~      The main objective of this study is to evaluate the patient perspective in the treatment of~     advanced renal cell carcinoma with an oral anti-cancer drug.~      The following aspects will be investigated:~        -  Intrinsic desire for information about treatment.~        -  Patient satisfaction with treatment information.~        -  Patient satisfaction with treatment.~        -  Medication adherence.~        -  Health-related quality of life.~        -  The role of different health care professionals in the treatment of RCC with oral drugs~      This study should reveal information necessary for the development of pharmacotherapeutic~     care concepts that meet the needs of cancer patients treated with an oral anti-cancer drug~     over a long period.~   "
100824|NCT02247570|"~     The specific aim of this proposed study is to compare the effectiveness of Vestibular~     Rehabilitation (VR) in patients with PTSD who have suffered combat related traumatic brain~     injuries in a randomized controlled trial in terms of PTSD symptom reduction.~   "
100825|NCT02247557|"~     To evaluate the efficacy and safety of intravesical instillation of Lipotoxin for the~     treatment of IC/BPS~   "
100826|NCT02247544|"~     This is an Italian, multicentre, single arm, phase II study, with an intra-patient comparison~     end point. This study aims at confirming the activity of the drug trabectedin as~     second/further line treatment in retroperitoneal leiomyosarcoma and well~     differentiated/dedifferentiated liposarcoma expressed in terms of slowing down tumour growth.~      Another objective is to investigate this peculiar benefit of trabectedin in typical~     retroperitoneal sarcomas may be exploited to help multidisciplinary clinical decision-making~     in the management of retroperitoneal sarcomas~   "
100827|NCT02247531|"~     This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled~     study evaluating the efficacy and safety of lampalizumab administered by intravitreal~     injections in participants with geographic atrophy (GA) secondary to age-related macular~     degeneration (AMD).~   "
100828|NCT02247518|"~     The purpose of this study is to investigate to effect of tamsulosin on the pharmacokinetic~     properties of tadalafil~   "
100829|NCT02247505|"~     The purpose of this study is to investigate to effect of tadalafil on the pharmacokinetic~     properies of tamsulosin~   "
100830|NCT02247492|"~     Clinical evaluation of the Orsiro LESS in subjects requiring coronary revascularization with~     Drug Eluting Stents (DES). Along with it, an explanatory (hypothesis-finding) problem will be~     investigated, whether the patient's body inflammation status correlates with the clinical~     outcome.~   "
100831|NCT02247479|"~     This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled~     study evaluating the efficacy and safety of lampalizumab administered by intravitreal~     injections in participants with geographic atrophy (GA) secondary to age-related macular~     degeneration (AMD).~   "
100832|NCT02247466|"~     The purpose of this study is to investigate surgical work space and surgical conditions in~     patients scheduled for laparoscopic umbilical, -linea alba and incisional herniotomy. The~     patients will act as their own control with evaluation of surgical work space and surgical~     conditions during both deep NMB and no NMB.~   "
100833|NCT02247453|"~     In the present project we propose a large prospective study in heavy smokers volunteers based~     on plasma miRNA profiling to assess its efficacy as a first line screening test for lung~     cancer detection.~      The study will be articulated in different phases: i) analysis of 1000 plasma samples of~     disease-free smokers already collected in our biological repository in the last two years ii)~     de-novo enrollment of 4000 smoking volunteers, collection of their blood samples and~     inclusion in a program of active surveillance on the basis of their miRNA risk profile iii)~     assessment of miRNA expression profile using a custom made microfluidic card containing the~     24 miRNA previously identified in the diagnostic signatures iii) bioinformatic analyses of~     miRNA ratios in the cohort in order to determine which individuals are in presence or will~     develop lung cancer and in particular the aggressive form of the disease iv) assessment of~     the best diagnostic and treatment algorithm for subjects with suspicious miRNA profiles v)~     functional validation of miRNAs as novel therapeutic targets using novel cellular genetically~     engineered models of transformation and patients' tumorgrafts models.~   "
100834|NCT02247440|"~     This is a study of HCV treatment using the standard regimen of pegylated-interferon plus~     ribavirin in HIV co-infected patients participating in the PHPT cohort study. The treatment~     will be implemented in conjunction with gastro-enterologists/hepatologists by internists~     responsible for the participant's HIV treatment.~      Chronic hepatitis C virus (HCV) infection is responsible for several severe and life~     threatening complications, which are worsened by HIV co-infection. HIV-HCV co-infected~     patients are at a higher risk of death compared to HIV mono-infected individuals, even if HIV~     replication is suppressed on antiretroviral treatment.~      The goal of HCV antiviral treatment is to cure HCV infection. Curing HCV infection allows~     fibrosis regression, improved clinical outcomes. In addition, individuals who have been cured~     are no longer contagious to other individuals, therefore widespread access to HCV treatment~     may contribute to the control of the HCV epidemic.~      A combination of injectable pegylated-interferon with oral ribavirin is currently the~     recommended regimen for the treatment of hepatitis C in the setting of HIV co-infection. They~     are administered for 24 weeks in HCV mono-infected patients but need to be administered for~     one year in HIV-HCV co-infected patients. Newer drugs, such as the first generation HCV~     protease inhibitors (boceprevir, telaprevir), administered concomitantly, are used in~     patients who have not been cured using peg-interferon + ribavirin, and may allow for shorter~     treatment.~      PRIMARY OBJECTIVE~      1. To determine the percentage of patients according to genotypes with sustained virological~     response 6 months after treatment discontinuation (SVR).~      HCV TREATMENT~        -  Peg-interferon alpha 2-b (a subcutaneous injection of 1.5 micrograms/kg once a week)~        -  Ribavirin dosing according to HCV genotype and body weight; dose adjustment in case of~          anemia.~      A total of 60 patients could be enrolled in the study: 15 HCV-HIV co-infected patients in a~     first part (starting in August 2014) and 45 patients in a second part, depending on funding.~   "
100835|NCT02247427|"~     The purpose of this study is to determine clinical outcomes related to deactivation of~     Cardiac Resynchronization Therapy device in subjects with super response.~   "
100836|NCT02247414|"~     The purpose of this study is to determine whether Warfarin Anticoagulation are effective and~     safe in Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients after Laparoscopic~     Splenectomy and Azygoportal Disconnection for Portal Hypertension~   "
100837|NCT02247401|"~     This study evaluates the efficacy and safety of ABT-450/r/ABT-267 with RBV in treatment-naive~     and treatment-experienced HCV GT4 subjects without or with compensated cirrhosis.~   "
100838|NCT02247388|"~     To study the efficacy of AB-CASI against standard of care in a randomized controlled trial in~     the Emergency Department.~   "
100839|NCT02247375|"~     Safety, pharmacokinetics, pharmacodynamics [CD11b/CD18 (Mac-1) expression] and efficacy.~   "
100840|NCT02247362|"~     One dose of escalating strengths of an investigational influenza vaccine, VAX2012Q~     (Quadrivalent Recombinant Hemagglutinin Seasonal Influenza Vaccine), will be evaluated for~     safety and immunogenicity in healthy adults 65 to 75 years of age in this placebo-controlled~     study.~   "
100841|NCT02247349|"~     The purpose of this study is to determine the safety, tolerability, pharmacokinetics,~     immunogenicity, antitumor activity and pharmacodynamics of BMS-986012 alone and in~     combination with nivolumab in patients with relapsed/refractory SCLC.~   "
100842|NCT02247336|"~     Family health history can help identify patients at higher than average risk for disease.~     There is no standardized system for collecting and updating family health history, using this~     information to determine a patient's disease risk level, and providing screening~     recommendations to patients and providers. Patients will enter their family health history~     into MeTree, a family history software program. The program will produce screening~     recommendations tailored to the patient's family health history. The investigators will~     examine whether this process increases physician referrals for, and patient uptake of,~     guideline-recommended screening for colorectal cancer.~   "
100843|NCT02247323|"~     The investigators are assessing the incidence of ovarian cancer in premenopausal women who~     were at moderate risk of malignancy with low CA125.~   "
100844|NCT02247310|"~     Considering the significance of an early and consequent Multiple Sclerosis (MS) treatment as~     well as the challenge to achieve high adherence to treatment, evaluating the benefits of any~     new measure to improve adherence is important. The data storage capabilities of the~     BETACONNECT device, including the automated recording of injections, will facilitate the~     collection of reliable data on patient's injection behavior and adherence, which should be~     unaffected by recall bias or reporting bias.~      To better understand the utilities of the new BETACONNECT device and characterize its~     contribution to adherence, we plan to prospectively follow-up MS patients using this device~     for 24 weeks. The study will take place in a real-life setting in Neurology centers across~     Europe.~   "
100845|NCT02247297|"~     This prospective, single centred cohort study evaluates the physiological course of the~     potentially novel biomarker PSP in pregnant women as well as its predictive role in the~     development of inflammatory complications during pregnancy.~   "
100846|NCT02247284|"~     The purpose of this study is to assess and compare the repeatability of SD-OCT (Spectralis™~     OCT, Version 6.0, Heidelberg Engineering, Germany) RNFL thickness measurements with a new~     software (glaucoma premium module) with the well established peripapillary RNFL thickness~     measurements in patients with primary open angle glaucoma.~   "
100847|NCT02247271|"~     This project is a partnership between the University of Victoria and the eleven Diabetes~     Health Centres in the Fraser Health Region of British Columbia, Canada. The primary goal of~     this project is to evaluate the feasibility, viability, and effectiveness of using peer~     health coaches to assist persons with type 2 diabetes who are experiencing challenges in~     managing their diabetes. The University of Victoria will recruit and train sixty coaches with~     various cultural and socioeconomic backgrounds representing a community of practice. Coaches~     will also have type 2 diabetes or be familiar with type 2 diabetes and will have led or taken~     the Diabetes Self-Management Program in English, Punjabi or in Aboriginal communities.~     Training will also include navigating the health care system, accessing mandated health and~     employment- related services, importance of medication adherence and ability to understand~     health care instructions. One hundred and fifty subjects with type 2 diabetes will be~     recruited by Diabetes Health Educators or through community newspaper ads. Eligibility~     criteria for subjects include: adults with type 2 diabetes who speak English or Punjabi~     living in the Fraser Health region. A one group pre-post matched design will be used. Both~     participants and coaches will complete questionnaires at baseline, six and twelve months. The~     Diabetes Coaches will provide assistance to subjects for a period of 6 months. A project~     community advisory committee comprised of the researchers, Diabetes Centre administrative~     staff, clinicians, coaches, subjects, key community leaders and representatives from the~     diabetes industry will meet every three months to guide implementation and sustainability.~     Qualitative research methods (i.e., focus groups and interviews) will be used to gather~     feedback, perspectives, and opinions of all the stakeholders.~   "
100848|NCT02247258|"~     The objective of this study is to evaluate if in the prevention of postoperative recurrence~     of ileal Crohn's disease immediate initiation of azathioprine postoperatively is superior to~     delayed (6- 12 mths.) introduction of azathioprine upon disease recurrence assessed by~     endoscopic criteria. The primary endpoint, disease recurrence, encompasses symptomatic and~     surgical recurrence as well as severe endoscopic lesions at the final, 2 year, assessment.~   "
100849|NCT02247245|"~     To examine the effects of heart rate reduction on exercise capacity in control subjects and~     patients with chronic heart failure.~   "
100851|NCT02247219|"~     The study aims at:~      Using Intervention mapping as a planning approach for behavior change intervention programs,~     based on an ecological approach to health and local community and user participation.~        -  Explore the behavioral change processes utilizing qualitative methods.~        -  Develop theory-based behavior change programs across different domain at healthy living~          centres.~        -  Evaluate the effect of behavior change intervention programs across different domains.~        -  Increase health providers` competence in effective behavioral change intervention~          techniques by networks and education seminars between municipalities and research~          groups.~        -  The programs will specifically target the underlying causes of chronic disease. The~          investigators will map the distribution of lifestyle habits among individuals and~          families. The investigators will also explore how lifestyle habits relate to known~          determinants of social health inequality, such as adverse previous experiences,~          participation in working life and low income.~        -  The investigators also intend to study if socioeconomic differences are of importance~          for entering or dropping out of HLC interventions, and the ability to sustain lifestyle~          changes. The investigators will do so by stratified analyses, or by using socioeconomic~          variables as determinants in effect analyses.~   "
100852|NCT02247206|"~     The purpose of this research is to examine the preliminary efficacy, feasibility, and~     acceptability of Voice over Internet Protocol delivered behavior therapy for Tourette~     Syndrome through in a randomized waitlist-controlled trial.~   "
100853|NCT02247193|"~     Objectives: To determine if the use of botulinum toxin during primary cleft lip repair~     improves the cosmetic appearance of the scar~      Study Design: Double blinded randomized controlled trial~      Methods: Study to be completed at an academic tertiary hospital. Patients must be 6 months of~     age or younger with a unrepaired complete unilateral cleft lip and palate requiring a primary~     cheiloplasty. Botulinum toxin will be injected intraoperatively at 4 standardized sites in~     the cleft lip during surgical repair. Control subjects will receive a placebo injection in~     place of the toxin. Surgeons will be blinded to patients that receive the experimental~     injection. Outcomes will be determined using 3D-videography preoperatively and post~     operatively at scheduled visits with a total of one year follow up. A scar assessment~     questionnaire will be completed by parents at select post operative visits. Videography~     images will also be assessed by a blinded expert panel at the completion of the study.~   "
100854|NCT02247180|"~     This study aims to proof the efficacy of a cognitive rehabilitation program for patients with~     mild dementia in Alzheimers Disease with respect to activities of daily living.~   "
100855|NCT02247167|"~     Sleep disordered breathing (SDB) is a common disease in both adults and children and is~     caused by the obstruction of the upper airway during sleep. Unlike adults, most cases of~     paediatric SDB are due to the presence of enlarged tonsils and adenoids, thus the main~     treatment option is adenotonsillectomy (AT). It is well known that obstructive sleep apnoea~     (OSA) in adults increases the risk for hypertension, coronary artery disease and stroke, and~     there is now mounting evidence that SDB also has a significant impact on the cardiovascular~     system in children with reports of elevated blood pressure, endothelial dysfunction and~     altered autonomic cardiovascular control.~      Oxidative stress seems to play a pivotal role in impairing flow-mediated dilation (FMD) and~     consequently enhancing cardiovascular risk in SDB patients but the underlying mechanism is~     still undefined.~      Previously, we demonstrated that endothelial dysfunction is directly related to NADPH oxidase~     activation. Furthermore, recently we assessed the association between OSA, endothelial~     dysfunction and oxidative stress in adults showing that increased NADPH oxidase-generated~     oxidative stress and arterial dysfunction are partially reversed by nasal continuous positive~     airway pressure treatment.~      There is evidence in literature that cardiovascular morbidities associated with SDB are~     potentially reversible in children; AT may have a significant role in reversing the~     cardiovascular sequelae of SDB (e.g. children with OSA).~      Nowadays, there aren't studies that analyzed the role of NADPH oxidase-generated oxidative~     stress in SDB children.~      The purpose of the current research project is to examine the role of NADPH oxidase activity,~     oxidative stress, inflammation and endothelial function in SDB children, understanding the~     mechanisms involved in this disease.~      Furthermore we will analyse the effect of a AT on inflammation, oxidative stress, NADPH~     oxidase activity and endothelial function in SDB children.~   "
100856|NCT02247154|"~     To determine:~        1. The safety of Vigam® Liquid in patients with primary or secondary antibody deficiency~          (PAD or SAD).~        2. The efficacy of Vigam® Liquid in patients with primary or secondary antibody deficiency.~        3. The half-life of Vigam® Liquid after 4 months of treatment.~        4. The subclass and total gammaglobulin concentrations after each infusion of Vigam®~          Liquid.~   "
100857|NCT02247141|"~     The primary objective was to determine the efficacy of Human Normal Immunoglobulin (Subgam®)~     given subcutaneously by weekly infusion to patients with primary antibody deficiency.~      The secondary objective was to determine the safety of Subgam® given subcutaneously by weekly~     infusion to patients with primary antibody deficiency.~   "
100858|NCT02247128|"~     At present, a variety of antithrombotic regimens are prescribed in the early postprocedure~     period after transcatheter aortic valve implantation (TAVI). Dual antiplatelet therapy (DAPT)~     using aspirin and a thienopyridine in the initial period after TAVI is the recommended~     strategy; however, mono antiplatelet therapy using aspirin is suggested not to be inferior.~     In patients with atrial fibrillation (AF) or another indication for oral anticoagulation~     (OAC), no recommendations on best treatment regimen currently exist although triple therapy~     (OAC + DAPT) is best avoided due to increased bleeding risk.~      We hypothesise that the omission of clopidogrel in the first 3 months after TAVI is safer and~     not less beneficial than the addition of clopidogrel to aspirin (cohort A) or OAC (cohort B).~   "
100859|NCT02247115|"~     The establishment of a number of training programs in therapeutic endoscopy, standardization~     of the performance of endoscopic ultrasound (EUS) and endoscopy retrograde~     cholangiopancreatography (ERCP) and definition of competence is of paramount importance. The~     length of training and minimum number of procedures, requisite theoretical learning and~     methodology to define competence in EUS and ERCP are not well defined. The investigators~     research has demonstrated that individuals in training acquire skills at different rates and~     the number of procedures completed alone is a suboptimal marker for competency in a given~     procedure. Hence, emphasis needs to be shifted away from the number of procedures performed~     to performance metrics with well-defined and validated thresholds of performance. Multicenter~     prospective data are needed to help guide development of competency based medical education~     that define learning curves in EUS and ERCP and set evidence-based benchmarks required to~     achieve competence using a validated competency assessment tool.~      Hypothesis: The central hypothesis is that a validated EUS and ERCP competency assessment~     tool will allow for reliable and generalizable standardized learning curves, competency~     benchmarks and creation of a centralized national database that compares a trainee's~     performance amongst peers.~   "
112426|NCT02095899|"~     The purpose of this study is to test if rufinamide has an effect on chronic neuropathic pain~     in patients with a post thoracotomy pain syndrome.~   "
100861|NCT02247089|"~     Background:~      The sympathetic and parasympathetic branches (SNS and PNS) of the autonomic nervous system~     (ANS), keep our body in a state of balance, which can be disturbed in situations of~     uncontrolled stress. Sleep deprivation and specifically night shift is a source of stress~     with adverse consequences on sleep, wakefulness, eating patterns and cardio-vascular~     function. Furthermore, imbalanced autonomic profile is also associated with increased~     inflammation, a known risk factor for cardiac problems, diabetes, and cancer.~      Parasympathetic stimulation can control the inflammatory reaction, leading research toward~     interventions which can stimulate the cholinergic pathway. Among these interventions, massage~     therapy has shown to stimulate the PNS and bring back the balance within the body's organs.~      Objectives:~        1. To assess the physiological effects of night shifts on the ANS profile and bio-markers~          of inflammation and stress in blood~        2. To assess whether one session of massage therapy can revert the adverse effects of night~          shift via re-balancing these components.~      Methods:~      A pilot prospective randomized crossover trial with 10 healthy hospital staff is in progress:~      Each participants will be their own control. All participants will be measured for their~     baseline characteristics and outcomes of interest on a regular working day as well as at the~     end of 2 nights of shift work. At the end of one shift they will be randomly assigned to~     receive a 30-minute-long upper body massage, while at the end of the other shift they will~     receive a reading intervention which would serve as a control intervention. Randomization~     is done using a computer system that also verifies inclusion-exclusion criteria before~     allocating the intervention.~      The autonomic profile is measured by spectral analysis of Heart Rate Variability (HRV)~     captured by a state-of-the-art machine which non-invasively records electrical signals from~     the body. The inflammatory markers in the blood are also measured using top-notch laboratory~     technology.~      The results of the study will be reported by comparing the outcomes of each subject with~     their own baseline as well as comparing the two interventions for the effect of massage. Data~     will be pooled for all subjects in order to show the overall effect.~      The final results of this study will be used to plan stress management intervention trials.~   "
100862|NCT02247076|"~     The purpose of this study is to find out if meal timing affects calories burned and blood~     sugar levels.~   "
100863|NCT02247063|"~     The investigators are doing a study to learn about the effects of a type of low-energy~     non-surgical electrical brain stimulation (HD-tDCS) on chronic pain in people's jaw joints.~     Disorders in these joints are called temporomandibular joint disorders, or TMD.~   "
100864|NCT02247050|"~     This pragmatic trial examines the uptake and effects of primary care clinician commitments to~     follow 3 Choosing Wisely® recommendations. The investigators hypothesize that pre-encounter~     invitations to clinicians to commit to the recommendations will decrease ordering of: (1)~     imaging tests for low back pain, (2) antibiotics for acute sinusitis, and (3) imaging tests~     for headaches. The study is a mixed-methods, stepped wedge cluster randomized trial in which~     the intervention will be sequentially introduced to 6 clinics in southeastern Michigan in a~     randomly assigned order.~   "
100865|NCT02247037|"~     This study will determine if patient-derived tumor xenograft (PDX) mouse models can serve as~     a reliable model for treatment response for individual patients with triple negative breast~     cancer. The collection of patient tumor tissue will also provide insight into the mechanisms~     of therapeutic resistance for those individuals. Ultimately, this study will enhance our~     understanding of the genomic basis for treatment response for triple negative cancer on an~     individual basis, while having the potential to suggest new therapeutic options for high-risk~     triple negative breast cancer patients with residual disease post neoadjuvant.~   "
100866|NCT02247024|"~     Evaluation of pupillary reflex in patients on high-dose opioids. Clinical assessment of pain~     intensity, sedation score, and other side effects of opioids. Measurements of the~     concentration of opioids and their active metabolites in blood.~   "
100867|NCT02247011|"~     This proposed study was designed to investigate the prevalence of a 5-year incident~     osteoporotic fracture and evaluate the association of a 5-year change of 25-hydroxyvitamin D~     (25[OH]D)/bone turnover makers/bone mineral density (BMD) with the incident fracture in the~     Chinese postmenopausal women, based on an endeavor of a 5-year post-baseline follow-up visit~     of a previous cross-sectional study, PK-VF, in which 1724 participants were enrolled and~     examined.~   "
100868|NCT02246998|"~     The primary objective of this study is to assess glomerular function before and during~     administration of stribild (STB; elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil~     fumarate (E/C/F/TDF)) or a regimen containing TDF without cobicistat (COBI) as ritonavir~     (RTV)-boosted atazanavir (ATV/r) plus truvada (TVD; FTC/TDF) or atripla (ATR;~     efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF)) compared to a regimen~     containing neither TDF nor COBI as ATV/r plus abacavir/lamivudine (ABC/3TC) via determination~     of actual glomerular filtration rate (aGFR) using iohexol (a probe GFR marker) plasma~     clearance and estimated (calculated) glomerular filtration rate (eGFR).~   "
100869|NCT02246985|"~     Carotenoids are a family of pigments found abundantly in fruits and vegetables. They are~     responsible for the colour of many fruits and vegetables such as tomatoes, melon, peppers and~     orange coloured fruits and vegetables. Carotenoids such as beta-carotene are important for~     the human body as precursors of vitamin A. They are also thought to be important as~     anti-oxidants and may help protect against cancer and heart disease. Although many foods are~     rich sources of carotenoids poor bioavailability often limits the amounts that are absorbed~     and available for metabolism in humans.~      Devising practical ways and means of increasing carotenoid bioavailability could lead to~     better health outcomes. Processed foods are now widely eaten by many, both for their taste~     and convenience. No studies have thus far looked at the bioavailability of carotenoids that~     have been added into processed foods. Thus the purpose of this study is to investigate the~     bioavailability of carotenoids that have been incorporated into processed food products~     (bread and mayonnaise).~   "
100870|NCT02246972|"~     The proposed study is designed to test the clinical efficacy of the BRAVEMIND military sexual~     trauma (MST) system in an initial feasibility and wait list clinical trial of 45 users.~      The following hypotheses will be tested:~        1. Virtual Reality Exposure Therapy (VRET) will be safely deliverable to persons with~          posttraumatic stress disorder (PTSD) due to MST as evidenced by treatment dropout rates~          that are similar to existing Prolonged Exposure (PE) therapy delivered in military~          samples (20-40%) and by the absence of any critical incidents.~        2. Participants in the VRET group will show statistically and clinically meaningful~          reductions in PTSD and depression (PTSD Checklist-Military (PCL-M), Clinician~          Administered PTSD Scale (CAPS), and Patient Health Questionnaire (PHQ-9) scores and~          psychophysiological measures) following treatment.~        3. Participants in the VRET group will show statistically and clinically meaningful~          reductions in PTSD and depression (PCL-M, CAPS, PHQ-9 scores and psychophysiological~          measures) compared to wait-list results.~   "
100917|NCT02246361|"~     The purpose of this before-after prospective multicenter study is to assess the impact of~     six Patient Information Leaflets (PILs) on Doctor Patient Communication scale (DPC) and~     adherence scale for common acute illnesses in emergency ward.~   "
100873|NCT02246933|"~     This study evaluates whether a diet rich in poly-unsaturated fats can compensate for the~     negative effects of high saturated fat meals on metabolic, inflammatory, and coagulation~     responses. Half of the participants will receive a high polyunsaturated fat diet )50%~     carbohydrate, 15% protein, and 35% fat. 21% of total energy will be poly-unsaturated fatty~     acids, 9% mono-unsaturated fatty acids, and 5% saturated fatty acids) for 7 days, while the~     other half will receive a control diet 50% carbohydrate, 35% fat, and 15% protein 50%~     carbohydrate, 35% fat, and 15% protein. Only, 7% of total energy will be poly-unsaturated~     fatty acids, 15% of total energy will be mono-unsaturated fatty acids, and 13% of total~     energy will be saturated fatty acids.) for 7 days.~   "
100874|NCT02246920|"~     This double-blind, randomized, placebo-controlled, parallel group, multi-site study has been~     designed to compare the safety and efficacy of a generic Fluticasone propionate Nasal Spray,~     50 mcg (Teva Pharmaceuticals USA) to the FDA Reference Listed Drug, Flonase® (fluticasone~     propionate) 50 mcg nasal spray (GlaxoSmithKline), in the relief of the signs and symptoms of~     Seasonal Allergic Rhinitis. Additionally, both the test and reference formulations will be~     tested for superiority against a placebo nasal spray.~   "
100875|NCT02246907|"~     The purpose of this study is to evaluate the impact of an exercise intervention on~     patient-reported anxiety, depression, fatigue, and sleep disturbances among acute leukemia~     patients. The investigators hypothesize that exercise will reduce fatigue in acute leukemia~     patients.~   "
100876|NCT02246894|"~     The main objectives of this study are:~        -  to assess Optivate® consumption (IU/kg consumed per month for prophylactic and on-demand~          therapy and dose at each bleed).~        -  to assess clinical outcome when treating a bleed with Optivate®.~        -  to evaluate Optivate® in terms of clinical tolerance and safety in children under the~          age of 6 years. .~        -  to assess FVIII inhibitor development during the study.~   "
100877|NCT02246881|"~     The main objective of the study is to compare the pharmacokinetics of Optivate® with the~     subject's current FVIII concentrate when given as a bolus dose of 50IU/kg. The secondary~     objective is to compare the first and second pharmacokinetic assessments on Optivate® (and~     recovery if a subject changes batch) to evaluate Optivate® in terms of clinical tolerance and~     safety.~   "
100878|NCT02246868|"~     The main objectives of this study are to compare the first and second recovery assessments~     and recovery when a subject changed batch and to assess whether haemostasis was achieved with~     Optivate® when treating a bleed. The secondary objectives are to evaluate the clinical~     tolerance and safety of Optivate®.~   "
100879|NCT02246855|"~     The main object of the study is to compare the AUC0-84, of a single intravenous infusion of~     Vigam® Liquid (infused at the licensed rate of up to 3mL/min) with Gammaplex® (infused at up~     to 3mL/min and up to 6mL/min).~   "
100880|NCT02246842|"~     The primary objective of the study was to compare peak serum anti-D levels (Cmax) of BPL's~     D-Gam® 1500 IU to Rhophylac® 1500IU in RhD-negative healthy volunteers.~   "
100881|NCT02246829|"~     Aflibercept (EYLEA®) induces a rapid reduction in central retinal thickness (CRT) for~     patients suffering from neovascular age-related-macular degeneration.1 This early dramatic~     reduction in CRT is already observed through week 4. Therefore it might be not necessary to~     consistently perform each of the three monthly consecutive intravitreal injections of the~     so-called loading phase.~   "
100882|NCT02246816|"~     MP-101 will be evaluated in this study to see if it is safe and tolerable.~   "
100883|NCT02246803|"~     The aim of this study is a comparative evaluation of progression of paroxysmal atrial~     fibrillation in patients with coronary artery disease after isolated CABG and CABG combined~     with pulmonary vein isolation.~      Hypothesis of the study - patients with paroxysmal atrial fibrillation and coronary artery~     disease after CABG in combination with isolation of the pulmonary veins have a better~     outcomes for the progression of AF compared with patients undergoing isolated CABG.~   "
100884|NCT02246790|"~     Purpose. Comparison of outcomes in patients underwent CABG combined with left atrial and~     biatrial radiofrequency ablation of long-standing persistent atrial fibrillation.~      Hypothesis of the study - patients with long-standing persistent atrial fibrillation and~     coronary artery disease after CABG in combination with biatrial RFA have a better outcomes~     for the freedom of AF compared with patients undergoing left atrial RFA during CABG.~   "
100885|NCT02246777|"~     The purpose of this study is to assess the efficacy and safety of the Alcon Ex-PRESS™~     Glaucoma Filtration Device (Ex-PRESS) in Japanese patients with normal tension glaucoma.~   "
100886|NCT02246764|"~     The purpose of this study is to evaluate the ocular and systemic safety of Netarsudil~     (AR-13324) Ophthalmic Solution, 0.02% q.d. and b.i.d. for 12 months compared to the active~     comparator Timolol Maleate Ophthalmic Solution, 0.5%.~   "
100887|NCT02246751|"~     Little is known about how children with cerebral palsy (CP) use their sensory systems (touch,~     sense of body position, balance organs in the inner ear, vision) to help them achieve trunk~     control for independent sitting. If a child with CP does not achieve trunk control by 4 years~     of age their prognosis for motor skill development including walking is poor. Clinical~     researchers at The Movement Centre in Oswestry, England have developed a method called~     Targeted Training in which children train trunk control in small segments from the top down~     using a custom fit training device. This study aims to examine how children with moderate to~     severe CP use sensory information for trunk control before, during and after a program of~     Targeted Training.~   "
100888|NCT02246738|"~     Purposes are to determine whether various cohorts of bladder cancer patients have detectable~     tCTC's, determine it tCTC levels vary with the natural history of bladder cancer and to see~     if tCTC's provide novel information.Study population are various cohorts of patients~     diangosed with urothelial carcinoma of the bladder.Procedures include a venous blood draw, up~     to two times, over a 6 month period for collection of tCTC's. Up to 15 mL's of blood will be~     collected at each blood draw.~   "
100918|NCT02246348|"~     Doppler signals can be recorded from the lung parenchyma by means of a pulsed Doppler~     ultrasound system incorporating a special signal processing package; i.e. the transthoracic~     parametric Doppler (TPD) (EchoSense Ltd., Haifa, Israel). Systemic sclerosis patients often~     develop pulmonary vascular disease leading to pulmonary hypertension. The TPD system may~     provide important insight into pulmonary blood vessels characteristics by the LDS signals~     that are related to pulmonary hypertension.~      The TPD performance in detecting PAH in SSc patients will be assessed in the study.~   "
100889|NCT02246725|"~     In this trial, patients with cancer in the upper gastrointestinal canal who are going to~     receive first line palliative chemotherapy and patients with colorectal cancer who are going~     to receive second line palliative chemotherapy will be included. Participating patients will~     be randomized between early contact with a palliative care unit, or contact with a palliative~     care unit when needed. The objectives with the trial is to investigate if an early~     establishment with a palliative care unit will have a positive impact on the patients quality~     of life, this also applies for the nearest relative, survival, and if a difference in numbers~     of chemotherapy cycles can be detected.~   "
100890|NCT02246712|"~     This study aimed to investigate the influence of uncontrolled type 1 and type 2 diabetes~     mellitus (DM) on the kinetic disposition, metabolism and pharmacokinetics-pharmacodynamics of~     tramadol enantiomers in patients with neuropathic pain. Thus, nondiabetic patients (control~     group, n = 12), patients with type 1 DM (n = 9), and patients with type 2 DM (n = 9), all~     with neuropathic pain and phenotyped as extensive metabolizers of cytochrome P450 2D6~     (CYP2D6) who were treated with a single oral dose of 100 mg racemic tramadol were~     investigated.~   "
100891|NCT02246699|"~     The prevalence of overweight and obesity is getting more and more important in developed as~     well as in emerging countries. It can be defined according to the degree of fat storage by~     measurement of fat mass.~      No clinical studies have been conducted so far for that intended use on KiOnutrime®-Cs, a~     fungal chitosan from the mycelium of non-genetically modified Aspergillus niger.~     KiOnutrime®-Cs has been recognized as substantially equivalent to animal chitosan.~      The purpose of this clinical trial is to determine if KiOnutrime®-Cs-containing medical~     device, which is a CE-marked medical device manufactured by KitoZyme, has an effect on body~     weight reduction after 3 months of intake in overweight and obese men and women. Furthermore,~     effects on anthropometric measurements, body fat mass percentage, serum lipids and safety~     parameters will be investigated.~   "
100892|NCT02246686|"~     The study will investigate efficacy of STW5-II as add-on therapy on the rate to remission in~     patients with mild to moderate ulcerative colitis in an acute flare.~   "
100893|NCT02246673|"~     This is a Phase 2a, randomized, open-label, multicenter study to assess the pharmacodynamic~     (PD) effects and safety of RDEA3170 administered in combination with febuxostat compared to~     febuxostat administered alone in adult subjects with gout.~   "
100894|NCT02246660|"~     The RESTORE trial will determine whether resveratrol supplementation can improve walking~     performance in older people with lower extremity peripheral arterial disease (PAD).~     Resveratrol, a polyphenol and natural supplement, specifically targets several impairments~     associated with walking difficulty and mobility loss in people with PAD.~   "
100895|NCT02246647|"~     Our overall objective with this study is firstly to provide a comprehensive assessment of~     intestinal permeability, mucosal barrier function using existing biomarkers and secondly to~     explore novel biomarkers for measuring intestinal permeability in patients with constipation~     predominant Irritable Bowel Syndrome (IBS-C).~   "
100896|NCT02246634|"~     Patients diagnosed with colorectal cancer routinely undergo a CT scan to identify whether the~     cancer has spread to other parts of the body, but diagnosis of secondary cancer in the liver~     is difficult using conventional CT. MRI is known to be better than CT at diagnosing cancer in~     the liver but it takes a long time to do. Recently it has been suggested that limited MRI of~     the liver can identify most cancer in the liver, however this has not yet been proven to be~     effective in patients with a new diagnosis of colorectal cancer. The purpose of this study is~     to test whether a quick MRI scan of the liver at the time colorectal cancer is diagnosed can~     identify more cancer that has spread to the liver than conventional CT.~      All patients who have been diagnosed with a high risk type of colorectal cancer but no liver~     metastases on CT will be eligible to take part in the study.~   "
100897|NCT02246621|"~     The main purpose of this study is to evaluate how effective nonsteroidal aromatase inhibitors~     (NSAI) plus abemaciclib are in postmenopausal women with breast cancer. Participants will be~     randomized to abemaciclib or placebo in a 2:1 ratio.~   "
100898|NCT02246608|"~     This study evaluates the therapeutic effect of Oasis® Matrix along with Negative Pressure~     Wound Therapy (NPWT) on pressure wounds. Either Oasis or standard foam will be applied to the~     wound prior to activating the NPWT.~   "
100899|NCT02246595|"~     The trial enrolls patients with early severe sepsis or septic shock displaying at least one~     newly developed organ dysfunction and showing clinical evidence of pulmonary or abdominal~     infection. The primary goal of the trial is to assess the pharmacokinetics and~     pharmacodynamics of the new monoclonal antibody CaCP29 and to characterize safety and~     tolerability as well as evaluate parameters of efficacy.~   "
100900|NCT02246582|"~     The purpose of this study is to demonstrate the performance of the Enlite 3 Sensor over 168~     hours (7 days) when inserted in the abdomen and used with the Guardian Mobile App and 640G~     Pump in subjects aged 14-75 years with type 1 or type 2 diabetes.~   "
100901|NCT02246569|"~     For patients with emphysema lung volume reduction (ELVR) could be an expedient approach for~     the reduction of distension of the lung. ELVR may be performed using RePneu® Coils. After the~     insertion of the coils distended lung sections shrink so that healthy parts can expand.~      In the present study investigators intend to examine, whether the insertion of the coils~     improves diaphragm function and force of the breathing muscles. Investigators hypothesize~     that reduction of lung volume eliminates or reduces flattening of the diaphragm and relieves~     breathing muscles, respectively respiratory pump, which aims to reduce dyspnea.~   "
100902|NCT02246556|"~     This was a randomized, masked, controlled study of the effect of a virtual reality,~     binocular, 3-dimensional video game on visual acuity and stereopsis in adult patients with~     amblyopia. The trial has been halted as of June 2016 and will not be evaluating any new~     subjects for enrollment.~   "
100919|NCT02246335|"~     Total Hip Arthroplasty is equal to or better than Hemiarthroplasty in the treatment of~     displaced femoral neck fractures in the elderly-elderly~   "
100957|NCT02245841|"~     This study will assess the safety and efficacy of H.P. Acthar gel for treating the cutaneous~     manifestations in patients with refractory classic dermatomyositis, juvenile dermatomyositis,~     and amyopathic dermatomyositis. Our hypothesis is that H.P. Acthar gel will be both safe and~     effective for such patients.~   "
111728|NCT02104999|"~     Study to test the technical accuracy and userfriendliness of a Point-of-care C Reactive~     Protein device (POC CRP device) in comparison with laboratory CRP testing in nursing home~     residents~   "
100903|NCT02246543|"~     This study will have the primary aim to investigate within-day changes in appetite after~     consumption of high-protein (HP, 30% of calories) and normal, or low, protein (LP, 15% of~     calories) whey protein meal, in solid and liquid form, on appetite and ad libitum food~     intake. Secondary objective will be to assess the statistical relationship between plasma~     concentrations of gut hormones and visual analogue scales (subjective hunger and fullness)~     and transit time.~      In order to investigate the interaction of food structure and protein content on appetite,~     this requires, in practice, either a differing amount (g) or calorie (kJ) load as a function~     of energy density (defined as kJ/100g). Delivering the test meal as a solid and liquid form~     gives an easy solution to achieve this manipulation without compromising the nutritional~     profile. Following on from this decision, it is easier to produce different preloads using~     whey protein (rather than meat protein), since it is easily incorporated into test meals.~   "
100904|NCT02246530|"~     The goal of this project is to identify an effective and conservative approach to treating~     partial thickness rotator cuff tears (PTRCT) that otherwise would end with a surgical~     correction needed.~   "
100905|NCT02246517|"~     Important pharmacological agents for treatment of chronic neuropathic pain such as ketamine~     block NMDA receptors. Nitrous oxide, an inhalant agent used extensively In anesthesia, also~     have antagonist property of NMDA receptors. The investigators hypothesize that prolonged~     treatment with N2O can alleviate chronic neuropathic pain of different causes (e.g. diabetic~     neuropathy, post herpetic neuralgia etc.).~   "
100906|NCT02246504|"~     The purpose of this study is to evaluate thyroid nodule's volume, structure and~     vascularisation changes following HIFU therapy assessed by ultrasonography~   "
100907|NCT02246491|"~     This research is being done to better understand the causes of the disease~     Ataxia-Telangiectasia and, in the longer-term, develop new therapies for the disease using~     stem cells.~      Induced pluripotent stem cells (iPSC) are a type of cells that can be made in the laboratory~     from cells in your body, such as blood cells or skin cells (fibroblasts). These stem cells~     can then be used for research purposes. For example, stem cells can be used to investigate~     how the mutation in ATM causes the actual symptoms of Ataxia-Telangiectasia. In addition, the~     stem cells can be used to screen for drugs that could be helpful to treat the disease or to~     develop new laboratory techniques to correct the mutation that causes Ataxia-Telangiectasia.~     where the mutation that causes the disease is corrected by the investigators. The stem cells~     generated in this study will not be used directly for patient therapy and therefore this~     research does not have a direct benefit to you. However, it will help advance our~     understanding of the disease and develop future therapies.~      Patients who enroll in this study will get all of the standard therapy they would get for~     their tumor whether or not they participate in this study. There is no extra or different~     therapy given. The study involves a one-time procedure (either blood collection or skin~     biopsy).~   "
100908|NCT02246478|"~     The objective of this study is to evaluate the safety and pharmacokinetic of TAS-205 in~     patients with Duchenne Muscular Dystrophy.~   "
100909|NCT02246465|"~     The purpose of this study is to determine the effectiveness of RXI-109 in reducing the~     recurrence of hypertrophic scar formation following elective revision of a pre-existing~     hypertrophic scar.~   "
100910|NCT02246452|"~     The main objective of this study was the assessment of the nutritional status of children and~     adolescents aged between 0-18 with malignancies based on BMI percentiles and standard~     deviation scores, at diagnosis, during treatment and during a period of two years after the~     end of therapy.~   "
100911|NCT02246439|"~     Randomized, Placebo-Controlled, Phase 3 Trial of RHB-102 (BEKINDA) (Ondansetron 24 mg Bimodal~     Release Tablets) for Acute Gastroenteritis.~      The study will evaluate the safety and efficacy of RHB-102 (BEKINDA) in treating Acute~     Gastroenteritis, by comparing it to placebo.~   "
100912|NCT02246426|"~     This study is a multi-site, prospective, parallel arm, double-blind, randomized, controlled~     clinical trial to assess the efficacy of an experimental software program targeting social~     cognitive abilities versus a computer-based software control. Both the study and the software~     being investigated meet the criteria of Non-Significant Risk.~   "
100913|NCT02246413|"~     The RAINBOW study is an NIH R01-funded randomized controlled trial to evaluate the clinical~     and cost effectiveness and implementation potential of a primary care integrated~     multicondition intervention program to help improve mood and weight for obese adults with~     clinically significant depressive symptoms. The ENGAGE study is a mechanistic investigation~     added to the main trial with funding through the NIH common fund for the Science of Behavior~     Change roadmap initiative. Beginning Jan 11, 2016, at least 100 of newly enrolled trial~     participants will be consented to undergo additional assays evaluating neurobiological~     mechanisms of self-regulation.~   "
100914|NCT02246400|"~     The eCMP Pilot aims to study the feasibility and potential effectiveness of an~     electronically-mediated CardioMetabolic Program (eCMP) for therapeutic lifestyle change among~     adults with or at high risk for type 2 diabetes, heart disease, and/or stroke.~   "
100915|NCT02246387|"~     Native tissue repair for pelvic organ prolapse (POP) is the predominant surgical technique in~     the investigators department and the Manchester operation the preferred procedure. The~     investigators long-term reoperation rates for pevic organ prolapse are very low, as~     documented in the investigators previous long-term follow-up study (Oversand et al,~     International Urogynecology Journal 2013), however the data were retrospective and patients~     with avulsions of the levator ani muscle were not identified. The investigators hypothesize~     that correct fixation and elevation of the vaginal apex, as part of a three-compartment~     repair procedure, is essential in the POP surgical repair, also when treating women with~     levator ani avulsions.~      The purpose of this study is to:~        -  prospectively evaluate if cardinal/sacrouterine ligament plication (as part of the~          3-compartment Manchester procedure) gives an adequate elevation and fixation of the~          vaginal apex.~        -  assess changes in subjective symptoms between the preoperative evaluation and the 1 and~          5-year postoperative evaluations.~        -  evaluate whether the patients identified with levator avulsions in the investigators~          population have an increased risk of failure (objectively and subjectively).~   "
100916|NCT02246374|"~     This is primarily a safety protocol to evaluate the safety of unilateral subthalamotomy using~     Transcranial ExAblate in a staged, escalating dose titration manner; Stage I is~     subtherapeutic; Stage II is full, therapeutic unilateral lesioning.~   "
100920|NCT02246322|"~     Endoscopic ultrasound-guided fine-needle aspiration biopsy (EUS-FNA) is a reliable, safe, and~     effective technique for obtaining samples from the GI wall lesions and from organs adjacent~     to the GI tract (pancreas, nodes...).Needles available for EUS-FNA include 25G, 22G and 19G.~     Some studies have suggested that the 25G needle could be equal or even better than the 22G~     needle.~      The BXN system and neddles are is a newly developed for EUS-FNA. This trial is developed for~     testing the accuracy of the new neddle system for EUS-FNA and for comparing the two needles~     types, 25G and 22G.~   "
100921|NCT02246309|"~     Embryoscopes, allow for embryo culture to be performed in an automated incubation system~     under time lapse photography. Manufacturers of these systems (and investigators who have used~     these systems) claim that the availability of 24-hour time-lapse photographic control~     improves embryo selection and, therefore, IVF (in vtro fertilization) pregnancy rates. They~     also claim that use of this system saves laboratory personnel time.~      This study will randomize approximately 120 patients (60 in each arm) to standard embryo~     culture or to culture in an Embryoscope. The primary endpoint will be a comparison of time~     spent by the laboratory personnel with each system. Secondary endpoints will be IVF outcomes.~   "
100922|NCT02246296|"~     Inpatient treatment for complicated severe acute malnutrition (SAM) continues to have a high~     mortality in Africa. This is partly because children are commonly brought for admission~     because they are seriously ill, rather than being brought to hospital because of malnutrition~     alone. Mortality rates are especially high where SAM is complicated by HIV or TB. The early~     phase of inpatient nutritional treatment for severe acute malnutrition is based on a~     low-protein milk known as F75, which is given to improve metabolic homeostasis prior to the~     re-feeding to achieve catch-up growth. F75 provides a high proportion of energy from~     carbohydrates, including sucrose, lactose and maltodextrin. However, malabsorption of~     different types of carbohydrates, but lactose in particular, is known to occur in SAM and may~     lead to osmotic diarrhoea. Diarrhoea is common in children with SAM and is associated with~     increased mortality. Furthermore, switching from a catabolic state to a high energy diet that~     consists of predominantly carbohydrates can lead to 're-feeding syndrome' that may lead to~     severe electrolyte abnormalities and multiple organ dysfunction.~      The aim of this trial is to determine whether reducing the carbohydrate content of F75, and~     removing lactose, improves the stabilisation of severely malnourished children. The trial~     will involve randomising children who are eligible to receive F75 milk to either the current~     formulation or a revised formulation. Both formulations will be given according to current~     recommendations regarding frequency of feeding and caloric value. Since the purpose of F75 is~     to stabilise the child metabolically and biochemically, the primary endpoint of the trial~     will be time to stabilisation (the end of the first phase of treatment for severe acute~     malnutrition). Blood and stool samples at admission and after three days will be used to~     determine the effects on carbohydrate and fat malabsorption and evidence of the re-feeding~     syndrome. Children will be followed up until discharge from hospital. The project has been~     planned in consultation with the World Health Organisation (WHO) and, if the revised~     formulation of F75 results in improved outcomes, will lead to a global change in~     recommendations for its formulation.~   "
100923|NCT02246283|"~     The elderly demographic is on the rise - and this includes elderly living with schizophrenia.~     Yet very little is known about their lives, how they cope with their condition and how it~     develops over time.~      Research in this patient-group is sparse; overall there seem to be a tendency for elderly~     patients to manifest fewer psychotic symptoms and experiencing an increase in the~     psychological quality of life with older age. Opinions are divided on the degree and extent~     to which this tendency reflects remission and/or recovery in older patients.~      In order to identify factors associated with a positive outcome we:~        -  Investigate the course and the outcomes of the illness over the lifespan, as well as the~          life course and outcomes.~        -  Investigate the current status of mental and physical health, quality of life as well as~          functional competence of elderly (55+ yr) with schizophrenia.~      Also the investigators~      - Compare the trajectory and prognosis of schizophrenia (a chronic mental illness) with type~     1 diabetes (a chronic somatic illness).~      This study will yield vital insights into how schizophrenia develops over time, isolating~     factors that determine how well patients fare. The perspective is to advance knowledge of~     elderly with schizophrenia with a view to optimizing and increasing the effectiveness of the~     interventions offered to this group.~   "
100924|NCT02246270|"~     Urinary Tract Infections (UTIs) are the second most common infection in the body. UTIs~     account for five percent of all visits to primary care physicians. Many women who have had a~     UTI will develop recurring urinary tract infections. Recent studies suggest that some women~     who suffer from recurrent UTIs have urinary tracts that allow bacteria to adhere to it more~     readily than others. Women who suffered from bladder inflammation and recurrent UTIs were~     noted to have reduced UTIs and bladder inflammation with heparin bladder instillations.~     Heparin is a highly-sulfated glycosaminoglycan and stored within the secretory granules of~     mast cells and released only into the vasculature at sites of tissue injury. It has been~     proposed that, in addition to anticoagulation, the main purpose of heparin is defense at such~     sites against invading bacteria and other foreign materials. The central question the~     research is intended to answer is does Heparin bladder instillations decrease UTI rates in~     patients.~   "
100925|NCT02246257|"~     The primary aim of our present study is to evaluate the effect of a targeted, intensified,~     multidimensional intervention compared to conventional treatment of modifiable risk factors~     for CVD in patients with early RA. The primary endpoint, a composite of death from~     cardiovascular causes, non-fatal MI, non-fatal stroke and re-vascularisation, will be~     assessed after 5years' follow-up.~   "
100926|NCT02246244|"~     Escitalopram is an antidepressant inhibitor of the serotonin reuptake. On the market in~     France since 2002.~      Prevalence of emotional distress in patients with cancer is 30-50%. this prevalence may vary~     regarding the tumor localisation, the population, intensity of the symptoms...~      Incidence of ENT cancer is highly significant in France, it is one of the most important in~     the world 37 out of 100 000. it is in patients with ENT cancer that the prevalence of~     depression is the most important (22%-57%).~      Researches appears necessary to assessed the efficacy of antidepressant treatments with as~     primary objective not only the decrease of depressive symptoms but also an ensemble of physic~     and psychological symptoms.~   "
100927|NCT02246231|"~     Patients with Neurofibromatosis type 2 (NF2) almost always develop acoustic neuromas in both~     ears. As a result of the tumours themselves or the treatment of the tumours, many patients~     become profoundly deaf in both ears. It is possible to restore a degree of hearing by placing~     a hearing implant in the brainstem adjacent to the hearing pathways within the brain. This is~     termed an auditory brainstem implant (ABI).~      The aim of this study is to find the optimum head position in relation to the MRI magnet~     field, which would produce least area of image distortion in patients with ABIs. This will be~     of benefit in optimising the MR imaging in future patients with implants.~   "
111729|NCT02104986|"~     The main objective is to assess the benefit-risk ratio of a risk-adapted strategy for~     treatment of extra cranial NSMGCT in children and adolescent.~   "
100928|NCT02246218|"~     This is an open-label study consisting of a transition period to RAVICTI, followed by a~     safety extension period for at least 6 months and up to 24 months of treatment with RAVICTI,~     depending on age at enrollment. It is designed to capture information important for~     evaluating safety, pharmacokinetics and efficacy in young children.~      Subjects who are followed by or referred to the Investigator for management of their UCD.~     Subjects eligible for this study will include patients ranging from newborn to < 2 years of~     age with either a diagnosed or clinically suspected UCD.~   "
100929|NCT02246205|"~     The aim of the study is to compare the effect of Roux-en Y reconstruction (study group,~     DPCDA) versus classical Child reconstruction (DPCUN) in the incidence of VGL in patients for~     DPC. The hypotesis of the study is that Roux-en Y reconstruction decreases incidence of DGE~     after pancreaticoduodenectomy.~   "
100930|NCT02246192|"~     The use of plasma rich in growth factors in wound excision pilonidal sinus could improve the~     healing process of the wound, when compared with the usual technique of daily local healing.~     The investigators propose the objective of evaluating the efficacy of intra- and~     postoperative application of plasma rich in growth factors, to reduce healing time and~     complications, arising from its removal, compared to the standard surgical treatment.~   "
100931|NCT02246179|"~     The purpose of this study is to assess the efficacy of fractional CO2 laser assisted delivery~     of topically applied anesthetics (articaine hydrochloride 40 mg/ml and epinephrine 10 μg/ml~     solution and EMLA cream) regarding to anesthesia of the skin.~   "
100932|NCT02246166|"~     This phase IV multi-centre, randomised, double-blind, placebo-controlled, parallel-group,~     single-dose study will assess the efficacy and tolerability of the active tablets versus~     placebo in participants suffering from cold and influenza. Eligible participants will be~     randomly assigned to one of 2 treatment groups (active or placebo tablets) and enter a~     four-hour (hr) treatment phase. Each participant will be administered only once during each~     study period. Participants will use a questionnaire to record the symptom severity scores as~     described, as well as time.~   "
100933|NCT02246153|"~     -  Laparoscopy-assisted distal gastrectomy for the treatment of early gastric cancer (EGC)~          has been supported by high-quality evidence, and the high-level evidence for advanced~          gastric cancer based on large prospective randomized controlled trial as CLASS-01、JCOG~          0901, KLASS -02 is still awaited.Hopefully, it would have also gained the solid evidence~          of laparoscopy-assisted distal gastrectomy for the treatment of advanced gastric cancer~          (AGC).~        -  China has entered the aging society since 1999. Among the GC patients in China, the~          average age is 65 years old, which makes increasing attempts to explore laparoscopic~          techniques in the treatment of elderly patients.~        -  Nowadays, a considerable proportion of elderly patients suffer from multiple diseases,~          such as hypertension, diabetes, coronary heart disease. Thus the risk of intraoperative~          and postoperative complications can not be ignored. Unfortunately, there are rare~          studies specializing into the LAG for the GC patients of > 65 years old.~        -  Accordingly, the comparison of intraoperative and postoperative complications between~          laparoscopy-assisted and open distal gastrectomy for over 65 years old patients with~          gastric cancer based on a randomized controlled trial is warranted.~   "
100934|NCT02246140|"~     There is an association between intracranial arterial stenosis and ischemic stroke in young~     adults. The aim of this study is to evaluate the prevalence of intracranial arterial stenosis~     in asymptomatic regular resin of cannabis users in comparison with control subjects.~   "
100935|NCT02246127|"~     The purpose of this study is to elucidate which sequence of streptozotocin (STZ) based~     chemotherapy and the mammalian Target of Rapamycin (mTOR) inhibitor, everolimus, gives better~     results in terms of second Progression Free Survival (PFS) in well differentiated and~     advanced pancreatic NETs.~   "
100936|NCT02246114|"~     Our goal is to study self-monitoring of smoking as a means to reduce smoking in pregnant~     women. Investigators hypothesize that more regular self-monitoring, text messages and~     feedback as provided by home carbon monoxide monitoring device combined with medical feedback~     on results will reduce smoking during pregnancy compared to only receiving text message and~     no self-monitoring by home monitoring device and no feedback by home carbon monoxide~     monitoring device . The periconceptual period is a life period, where given the immediacy of~     the fetus and future child, a pregnant woman is willing to try and modify potentially harmful~     behaviors.~   "
100937|NCT02246101|"~     Environmental toxins exert damaging health effects in workers. Thousands of responders who~     worked or volunteered on the World Trade Center (WTC) rescue and recovery effort following~     the September 11, 2001 attacks suffer from health conditions or may be at increased risk for~     worsening health. In a pilot study, investigators identified the first evidence of kidney~     damage in subjects with very high exposure at Ground Zero. Specifically, noted was a~     preliminary association between the intensity of particulate matter exposure and albuminuria,~     a marker of early chronic kidney disease (CKD), systemic endothelial dysfunction, and~     increased cardiovascular risk.~      The long-term goal is to minimize the risk of CKD and cardiovascular disease (CVD) among~     individuals exposed to inhaled toxins. The primary objective of this research is to quantify~     the risk of kidney damage among first responders to the WTC attack and to determine the~     relationship to particulate matter exposure as well as determine an association between renal~     and cardiovascular damage in first responders and to explore potential mechanisms. The~     central hypothesis is that exposure to inhaled particulate matter causes systemic~     inflammation and endothelial dysfunction that result in chronic kidney and cardiovascular~     damage. This hypothesis will be investigated in a subgroup of participants from a previously~     conducted NIOSH-funded study Pulmonary Function Abnormalities, Diastolic Dysfunction and WTC~     Exposure: Implications for Diagnosis and Treatment (WTC-CHEST, PI Mary Ann McLaughlin).~      The proposed study will capitalize on unique resources in WTC-CHEST, including the~     standardized collection of data on particulate matter exposure and shared risk factors for~     CKD and cardiovascular disease, and cardiopulmonary function testing. The output from this~     proposal is anticipated to have a broad impact on understanding the health effects of inhaled~     particulate matter.~   "
100948|NCT02245958|"~     This study is a retrospective chart review to evaluate the doses of botulinum Type A toxins~     BOTOX® (onabotulinumtoxinA) and Xeomin® (incobotulinumtoxinA) used for the treatment of~     Cervical Dystonia and Blepharospasm in clinical practice.~   "
100949|NCT02245945|"~     The purpose of this trial is to assess the safety and acceptability of Tenofovir (TFV) 1% gel~     in adolescent females over 12 weeks of a minimum of twice weekly dosing following the BAT24~     regimen.~   "
100958|NCT02245828|"~     This is a double blind, randomized, placebo controlled, single and multiple ascending dose~     study in healthy subjects. Safety evaluation will include (serious) adverse events, vital~     signs, body weight and lung function tests. Blood samples for Pharmacokinetics will also be~     drawn at specified timepoints.~   "
112025|NCT02101125|"~     The purpose of this study is to evaluate the effect of concomitant administration of~     BMS-986020 on the single dose Pharmacokinetics (PK) of Rosuvastatin in healthy subjects.~   "
100938|NCT02246088|"~     Osteoarthritis (OA) is a frequent chronic musculoskeletal pathology that usually causes great~     disability and significant healthcare costs. Substantial scientific evidence indicates a role~     for central sensitization in OA pain. Reconceptualization of pain through Neuroscience~     Education (NE) is an intervention that has already been used successfully in some chronic~     musculoskeletal pain conditions characterized by alteration on CNS pain processing or central~     sensitization (i.e. chronic low back pain, chronic fatigue syndrome, widespread pain and~     chronic whiplash associate disorders).There is compelling evidence that NE have a positive~     effect on pain, disability, catastrophization and physical performance for chronic~     musculoskeletal pain disorders, yet studies examining the value of NE for OA patients are~     essentially lacking.~      The primary aim of this study is to assess the effect of NE on pain, disability and physical~     performance in subjects with chronic OA knee pain waiting for replacement surgery. This will~     be the first time NE will be addressed specifically to OA pain. To investigate the benefits~     of NE on pain related to knee OA, the effect of a manual therapy intervention combined with~     NE (MT+NE) will be compared with this same manual intervention plus an educational program~     based on a traditional patho-anatomical or biomedical model (MT+E). The following secondary~     aims will be addressed as well:~        -  Examining the effects of the two interventions on the mechanism of central sensitization~          in patients with knee OA;~        -  Examining the effects of the two interventions on pain catastrophizing, illness~          perceptions and kinesiophobia in patients with knee OA;~        -  Finally, it is aimed at identifying effect moderators for NE in patients with knee OA.~   "
100939|NCT02246075|"~     The purpose of this study is to evaluate the safety of 2 fixed doses of EVP-6124~     hydrochloride (HCl) compared to placebo for 24 weeks in subjects with mild to moderate~     Alzheimer's disease who are concurrently receiving stable treatment with memantine and~     currently receiving stable treatment or previously treated with an acetylcholinesterase~     inhibitor.~   "
100940|NCT02246062|"~     Background: Preoperative Anxiety is a negative factor in anesthetic and surgical experience.~     Among the strategies for reducing children's anxiety, non-pharmacological strategies are as~     important as the pharmacological ones, but their its validity is still controversial.~      Objectives: The aim of this study is to verify if the information provided to relatives as~     well as and smartphone application provided to children interferes in prevalence and level of~     child preoperative anxiety.~      Methods: Eighty four children, 4-8 years old, ASA I, II and III, undergoing elective surgical~     procedures and their relatives are randomly allocated into four groups: control group (CG)~     where the relative received conventional information about anesthesia; info group (IG),~     relative received an information leaflet about anesthesia; device group (DG), relative~     received only conventional verbal information and the child received smartphone application~     immediately before entering the operating room; device and info group (DIG) relative received~     a leaflet containing information and the child received smartphone application. Children's~     anxiety will be assessed using the modified Yale Preoperative Anxiety Scale (m-YPAS) on three~     occasions: at the ward (W), surgical theater in the waiting room (WR) and at the operating~     room (OR). Statistics analysis will employ by Kruskall-Wallis and Mann-Whitney tests for~     prevalence and level of anxiety in the groups.~   "
100941|NCT02246049|"~     The purpose of this study to assess efficacy and tolerability of combination therapy~     FOLFOXIRI with Bevacizumab (BV) as a first-line therapy in patients with metastatic~     colorectal cancer.~   "
100942|NCT02246036|"~     For Intensive Care Units (ICU) patients, Multiple Organ Dysfunction Syndrome (MODS) is a very~     common complication yielding high morbidity and mortality. Inadequate regional perfusion of~     certain organs (gut, kidney, liver, etc) often caused by shock is the main cause of MODS.~     Current practice uses cardiac output data and blood pressure to manage shock but there are~     still lacks of information about the regional perfusion. This leads to late MODS diagnostics~     preventing the implementation of adequate treatment.~      Gut perfusion monitoring seems to be a good target to assess the microcirculation but,~     nowadays, no practical methods or devices are available to measure the gut perfusion, and the~     current monitoring methods are not specific (CO, BP, OPS-SDF, PCO2, etc).~      MC Monitor trial is a prospective, multi-center pilot study, enrolling 10 patients.~      The probe will be used by intensivists on ICU patients with a risk of shock and requiring~     mechanical ventilation.~      The probe will be placed in the patient with an endoscopic procedure by a gastroenterologist~     (standard procedure for post-pyloric tubes placement). This procedure will be used to assess~     the status of the gut mucosa prior to the placement of the APD probe.~   "
100943|NCT02246023|"~     After randomization, the subjects undergo flexible bronchoscopy either with fractionated~     propofol administration or with propofol-TCI. Measurement of blood pressure, heart rate,~     oxygen saturation, and oxygen requirement are measured continuously during the procedure and~     thereafter. Cumulative propofol dose, and induction, procedure, and recovery time are noted~     continuously during and after the procedure.~   "
100944|NCT02246010|"~     The purpose of this study is to determine whether lactose-free milk will shorten the diarrhea~     duration and decrease its severity in formula-fed infants presenting to the Emergency~     Department (ED) or pediatric clinics with acute diarrhea.~   "
100945|NCT02245997|"~     The purpose of this study is to give 12T a smaller dose of radiation in order to decrease~     these late side effects.~   "
100946|NCT02245984|"~     Compare the clinical competence of undergraduate nursing students' of mashhad nursing and~     midwifery school in two groups applying nursing process (paper- based versus electronic).~   "
100947|NCT02245971|"~     Endoscopic submucosal dissection (ESD) is an advanced technique that enables en bloc~     resection of superficial tumors in the gastrointestinal tract. ESD, however, is a~     time-consuming procedure that requires a high level of endoscopic skill to achieve a~     desirable oncologic outcome. Especially, ESD for the lesion which is located in the antrum of~     lesser curvature side is difficult. Because the antrum of lesser curvature side is dependent~     position, irrigated water and blood may prevent visual field of ESD.~      Generally, whole precutting around the lesion during the ESD is performed prior to~     dissection. However, it is expected that partial precutting method for the lesion located in~     the antrum of the lesser curvature may improve the visibility of ESD because it can help us~     the flap of the lesion evaginated easily. Therefore, we aimed to evaluate the procedure time~     of ESD for the lesion located in the antrum of the lesser curvature according to the~     precutting methods (whole precutting vs. partial precutting).~   "
100950|NCT02245932|"~     The overall objective is to investigate the efficacy of resveratrol in modulating metabolism~     and CVD risk profile in patients with COPD. The primary objective is to investigate the~     effect of resveratrol on CRP as clinical marker of low grade systemic inflammation. The~     secondary objective is to investigate the effect of resveratrol on body composition,~     inflammatory status and mechanistic markers in blood, adipose and muscle tissue as well as a~     comprehensive assessment of metabolicand physical performance profile known to be affected by~     low grade systemic inflammation and by resveratrol.~   "
100951|NCT02245919|"~     Up to now, only little research has been performed in tailoring treatment of patients with~     chronic low back pain (CLBP). It would be interesting to evaluate a biopsychosocial~     intervention in patients with a moderate to high level of disability and in whom the~     contributing role of psychosocial factors to this disability is mild to moderate (WPN3-).~     Nowadays, these patients receive cognitive behavioral-based treatments in multidisciplinary~     rehabilitation settings but might also benefit from treatments based on these~     multidisciplinary rehabilitation treatment principles when provided by specifically trained~     primary care physical therapists. Therefore, the aims of this pilot-study are to evaluate the~     feasibility of a specifically for primary care physiotherapist developed biopsychosocial~     intervention (Back on Track intervention) in WPN3- classified patients, and to evaluate~     whether this Back on Track intervention results in a significant improvement in functional~     disability in this subgroup of patients.~   "
100952|NCT02245906|"~     The purpose of the study was to investigate how Brazilian fruits peel affect~     acute/postprandial glucose and insulin responses, inflammatory markers, appetite control~     peptides, antioxidative capacity, as well as subjective appetite ratings (VAS-visual analogue~     scales) in healthy volunteers. We hypothesize that certain Brazilian fruits peel added to a~     standardized meal will improve postprandial glucose tolerance and other metabolic biomarkers~     in healthy volunteers, compared with a similar meal without the corresponding plant~     materials.~   "
100953|NCT02245893|"~     This study evaluates fracture healing, anatomic reduction and return to functioning in~     patients with unstable Weber C type fractures of the ankle. Best outcomes are obtained when a~     good alignment of the ankle joint is maintained and natural function of the syndesmosis~     (space between the tibia and fibula bones) is restored. The syndesmosis and ankle joint is~     stabilized by a series of ligaments which are often damaged in Weber C type fractures.~     Current syndesmosis repair techniques traverse the tibia and fibula, but do not anatomically~     reconstruct the ligaments. The investigators will compare reconstruction of the unstable~     syndesmosis by open reduction and internal fixation using a syndesmosis screw coupled with~     anterior ligament (AiTFL) anatomic repair technique (ART) to percutaneous repair using a~     syndemosis screw only (SCREW). Radiographic, pain and functional outcome scores will be~     compared between the groups using validated outcome measures.~   "
100954|NCT02245880|"~     Intubation must be done with utmost care in cervical trauma patients. cervical spine motion~     must be minimized and intubation must be fast. The aim of this study was to compare the~     effectiveness of fastrach and glidescope. 18-65 years of age , ASA I-II 100 patients~     undergoing elective surgery were enrolled in this trial. After standard monitorisation~     including EKG , noninvasive blood pressure, pulse oximetry, anesthesia was induced with~     propofol and fentanyl. rocuronium was then administered for muscle relaxation. Patients were~     divided into two groups glidescope and fastrach. Rigid collar was placed then patients were~     intubated with one of these devices. Mask ventilations with or without collar were recorded.~     insertion times, intubation times of the devices were recorded. Peroperative hemodynamic~     parameters and postoperative minor complications were also recoded.~   "
100955|NCT02245867|"~     The purpose of this study is to examine the tolerance, safety, pharmakinetics, and possible~     clinical benefit of the good manufacturing practice (GMP)-grade amyloid fibril-reactive~     chimeric (Ch) IgG1 mAb 11-1F4 in patients with amyloid light-chain (AL) amyloidosis.~      The phase 1a part will involve at least 3 patients and a maximum of 18 patients. The first~     patient will receive the starting dose of the antibody and, if tolerated, the following~     patients will each receive (if tolerated) progressively higher doses of the antibody.~     Patients in part 1a of the trial will receive only one infusion of the drug. Patients treated~     in the phase 1a part receive lower dosage which might not be effective.~      Once the maximal tolerated dosage is established during the phase 1a part, the investigators~     will accrue patients to the phase 1b part of the trial. Patients will receive 4 infusions,~     once each week for 4 weeks. Patients who were treated in the part 1a of the trial and showed~     no toxicity can be also treated in the part 1b of the trial. The first patient will receive~     the starting dose of the antibody and, if tolerated, the following patients will each receive~     (if tolerated) progressively higher doses of the antibody. When the investigators reach the~     maximum tolerated dose without toxicity, the investigators e will enroll another 4 patients~     to receive the same dose. If there are no toxicities, another 4 patients will be treated at~     the next dose level, and so forth. Patients treated in Phase 1b may receive lower dosages~     which might not be effective. The goal of Phase 1b is to establish the tolerance and possible~     beneficial effects of 11-1F4. If successful, treatment with this antibody would represent a~     novel approach in the care of individuals with AL amyloidosis.~   "
100956|NCT02245854|"~     Colorectal cancer is a major cause of morbidity and mortality in Western countries.~     Scientific studies have shown that endoscopic polypectomy is efficacious in preventing CRC~     incidence and mortality.~      Endoscopic polypectomy carries a risk of major complications, such as bleeding or bowel~     perforation, so that a careful balance between efficacy and safety appears to be clinically~     relevant.~      Most of the polypectomies are performed for diminutive (<5 mm) or small (6-9 mm) lesions,~     which represent over 90% of all the polyps.~      To minimize the risk of complications when removing <10 mm polyps, cold-polypectomy~     techniques - i.e. without electric current - by means of biopsy forceps or snare, have been~     proposed.~      Although the risk of perforation is virtually excluded by cold-polypectomy, the lack of~     electrocautery may result in an increased risk of bleeding. The safety of cold-snare~     polypectomy has however been recently shown in controlled trials.~      Regarding the efficacy of cold-polypectomy for subcentimetric polyps, very few studies have~     assessed the post-polypectomy completeness of the removal of polyp tissue (i.e. residual~     disease), and no studies have compared it to conventional polypectomy.~      The investigators perform this study to assess both the efficacy and safety of a novel snare~     (Exacto™) for polyp removal.~   "
100959|NCT02245815|"~     The purpose of this study is to evaluate the incidence of necrotizing enterocolitis and its~     effect over the secreting immunoglobulin A in the feces with the use of probiotics of the~     strain Boucardii vs. Multispecies in premature newborns weighting less than 1500 g.~   "
100960|NCT02245802|"~     This study aimed to validate CU prediction model on mortality for patients with high risk~     bleeding peptic ulcers after therapeutic endoscopy.~   "
100961|NCT02245789|"~     Videolaryngoscopes become widely used. The aim of this study is to compare anesthetic~     induction when patients are tracheally intubated using a MacGraph Mac videolaryngoscope or a~     conventional MacIntosh laryngoscope.~      Tracheal intubation induces a nociceptive stimulation. Hypothesis is that the use of a~     videolaryngoscope induces a less pronounced nociceptive stimulation and, consequently, that~     it modifies the anesthetic drugs requirement. .~   "
100962|NCT02245776|"~     The purpose of the study was to analyze the benefit of autologous mononuclear cell therapy in~     incurable neurological disorders.~   "
100963|NCT02245763|"~     The TVT Registry™ is a benchmarking tool developed to track patient safety and real-world~     outcomes related to the transcatheter mitral valve repair (TMVR) procedure. Created by The~     Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC), the TVT~     Registry is designed to monitor the safety and efficacy of this new procedure for the~     treatment of mitral valve disease.~   "
100964|NCT02245750|"~     In the current study the investigators hypothesize that Routine Hysteroscopy prior to~     IVF/ICSI cycle increases the clinical pregnancy rate.~   "
100965|NCT02245737|"~     The purpose of this study is to assess the efficacy and safety of lanabecestat compared with~     placebo administered for 104 weeks in the treatment of early Alzheimer´s disease. The study~     will test the hypothesis that lanabecestat is a disease-modifying treatment for participants~     with early Alzheimer´s disease, defined as the continuum of participants with mild cognitive~     impairment (MCI) due to Alzheimer´s disease and participants diagnosed with mild dementia of~     the Alzheimer´s type, as measured by change from baseline on the 13-item Alzheimer's Disease~     Assessment Scale - Cognitive Subscale (ADAS-Cog13) score at week 104 in each of the 2~     lanabecestat treatment groups compared with placebo.~   "
100966|NCT02245724|"~     The purpose of this study was to analyze the benefit of autologous mononuclear cell therapy~     in mental retardation.~   "
100967|NCT02245711|"~     The purpose of this study was to study the effect of stem cell therapy on Limb Girdle~     Muscular Dystrophy patients.~   "
100968|NCT02245698|"~     The purpose of this study was to study the safety and effect of stem cell therapy on the~     functional recovery in patients with sub acute/chronic stroke.~   "
100969|NCT02245685|"~     This study is part of the french priorities of the 2007-2011 addiction plan. Priority #2 of~     the plan underlines the need to improve practices and access to opioid substitution~     treatment. Priority 3 stresses the importance of articulation and coordination between~     specialized structures and community medicine to optimize the quality of care and to ensure~     continuity in the followup of these patients. This study focuses on the followup of patients~     under substitution therapy from the moment they enter a specialized care center for addicts~     to the period they are monitored by a general practitioner outside the specialized care~     center. The assessment described in this study should allow to harmonize and keep a~     continuity in patient monitoring.~   "
100970|NCT02245672|"~     The purpose of this study is to determine whether MGR001 is equivalent to Advair Diskus when~     administered by inhalation in adult asthma patients~   "
100971|NCT02245659|"~     Clinical trial on effects of continuous positive airway pressure (CPAP) on glucose levels in~     pregnant patients with sleep-disordered breathing and gestational diabetes~   "
100972|NCT02245646|"~     This study aims at capturing for the first time at which frequencies and sound intensities~     hearing distortions are perceived after successful stapedotomy surgery. Also, the portion of~     patients perceiving these sound distortions and the length of time over which the distortions~     occur are assessed.~   "
100973|NCT02245633|"~     The aim of this research is to study how vitamin D affects various aspects of the disease~     process, such as inflammation, coagulation (ADAMTS13 and WVF) and miRNAs, in Diabetic kidney~     disease hemodialysis patients.~      Diabetes mellitus (DM) is one of the most common chronic diseases in nearly all countries.~     Diabetic kidney disease (DKD) traditionally has been referred to as diabetic nephropathy and~     is one of the microvascular complications of diabetes. Diabetic kidney disease (DKD) occurs~     in 25%-40% of patients with diabetes .~      Some studies have shown that the high risk of cardiovascular disease in diabetic patients~     with nephropathy is associated with increased plasma levels of von Willebrand factor (VWF)~     and decreased ADAMTS13 levels. VWF is a glycoprotein that plays an important role in platelet~     thrombus formation, whereas ADAMTS13 is a proteolytic enzyme that is responsible for~     degradation of large multimers of VWF released in the plasma by endothelial cells and~     platelets. Patients with both chronic kidney disease and diabetes have been shown to have~     higher plasma levels of VWF and decreased ADAMTS13 activity compared to healthy controls.~      Increased plasma levels of VWF, which reflects damage to endothelial cells and a~     hypercoagulability state, have been reported in atherosclerosis and diabetes. Thus, VWF and~     ADAMTS13 seem to be important players in the interface between diabetic nephropathy,~     hypercoagulability and atherosclerotic cardiovascular disease. Vitamin D deficiency is a risk~     factor for DM and hypertension. The investigators previous studies showed that adding~     calcitriol (activated vitamin D) to endothelial and vascular smooth muscle cells~     significantly down-regulated the inflammatory response of gene and protein expression~     involved in the nuclear factor kappa-light-chain-enhancer of activated B cells (NFĸB) signal~     transduction pathway. Micro RNA (miRNA) are short noncoding RNAs, 22-25 nucleotides long. As~     an endogenous production transcript, miRNAs can bind to the 3 untranslated regions (3 UTR) of~     its target messenger RNA (mRNA) in an imperfect, complementary manner, leading to~     post-transcriptional gene silencing. As a result, miRNAs can inhibit gene expression via mRNA~     degradation, translation inhibition, or transcriptional inhibition.The critical role of~     miRNAs has been established in several cellular and biologic processes, such as~     proliferation, differentiation, and development, and in the regulation of genes related to~     immune responses, cancer, and insulin secretion. MiRNA are involved in various biological~     processes and become novel biomarkers, modulators and therapeutic targets for diseases such~     as cancer, atherosclerosis, and DM.~      Significance: The high prevalence of cardiovascular morbidity and mortality in patients with~     DM on chronic hemodialysis remains a significant clinical problem and the finding of~     potential new biomarkers should be further investigated. This study aims to establish a link~     between ADAMTS13, VWF miRNA expression and vitamin D levels that can contribute to the~     development of new treatments for hemodialysis patients with diabetes.~      Methods: Each hemodialysis patient with diabetes in the investigators institute will be asked~     to participate in the study. After explaining the research goals, patients that agree to~     participate will sign an informed consent. The investigators estimate that the study will~     include 70 patients. Each patient will be assessed by a physician and 4 vials of blood will~     be taken while the patient is connected to the dialysis machine. The blood will be sent to~     the laboratory to check: 1) chemistry; 2) 1-25 vitamin D and 25- vitamin D levels; 3)~     ADAMTS13 activity and VWF; and 4) miRNA extraction. The patients will be grouped according to~     vitamin D levels (deficient /sufficient), and ADAMTS13, VWF and miRNA expression will be~     compared between the groups.~   "
100974|NCT02245620|"~     This study will be a Phase 2, randomized, double-blind, placebo-controlled study, enrolling~     40 elderly subjects with previous evidence of mitochondrial dysfunction to evaluate whether~     the administration of MTP-131 will change either hand skeletal muscle energetics or muscle~     performance in age-related skeletal muscle mitochondrial dysfunction.~   "
100975|NCT02245607|"~     This is a randomized study to compare Compensatory Cognitive Training (CCT) versus~     Recreational Therapy (RT) in Latino clinical high risk individuals in the US and Mexico.~      Study hypotheses: Compared to those who receive RT, study participants receiving CCT will~     show significant improvement in neurocognition, functional capacity, self-rated functioning~     and clinical measures.~   "
100976|NCT02245594|"~     In this study we would like to clarify the effect of long lasting Crohn's Disease on motility~     of the gastrointestinal system in patient and the effect regarding sleep disturbances. This~     will be done with a newly developed 3D-Motility-and-Transit-detector (Motilis Medica,~     Schweiz) and the well known polysomnographic equipment.~      Our hypothesises are:~      Patients with ileocoecal and/or colonic CD in remission and gastrointestinal symptoms have~     abnormal colonic transit (primary endpoint).~        1. Patients with ileocoecal and/or colonic CD in remission and gastrointestinal symptoms~          have abnormal gastric emptying and small intestinal transit (secondary endpoints).~        2. Total and segmental transit times found in patients with CD will be compared with~          corresponding transit times in healthy volunteers found in a previous study.~        3. Patients with ileocoecal and/or colonic CD in remission have abnormal sleep patterns.~        4. Nocturnal basic colonic activity, have changed in patients with ileocoecal and/or~          colonic CD in remission and sleep disturbances.~   "
100977|NCT02245581|"~     Patient characteristics, duration of surgery, and infusion volumes will be compared between~     the groups. Oxygen transport and organ function will be compared Length of hospital stay,~     morbidity, postoperative pain intensity were compared. Continuous variables will be analyzed~     using the student t-test and discrete variables will be analyzed using Chi-Square test.~     P-value <0.05 will be considered significant, where appropriate 95% confidence intervals will~     be calculated. Statistical analysis will be carried out using standardize statistical~     programs SPSS 12.0 for windows.~   "
112427|NCT02095886|"~     The purpose of this study is to select the best dose level (amount of drug given) and best~     formulation of the study drug (BMS-955176) to develop further.~   "
100981|NCT02245529|"~     The Objective of this study is to conduct a Prescription Event Monitoring (PEM) involving~     patients treated with Secotex® (Tamsulosin) in real life settings. The aim of a PEM is to~     monitor the safety profile of Secotex® in a cohort of patients with Benign Prostatic~     Hyperplasia as used in general practice~   "
100982|NCT02245516|"~     The primary objectives of the study are to evaluate the safety and effect of KPI-121 0.25%~     ophthalmic suspension and KPI-121 1.0% ophthalmic suspension on intraretinal or subretinal~     fluid secondary to Retinal Vein Occlusion or Diabetic Macular Edema.~   "
100983|NCT02245503|"~     The objectives of this post marketing surveillance study were to document the comorbidity and~     comedication during prescription of ALNA® (Tamsulosin) for patients with BPH (Benign~     Prostatic Hyperplasia).~   "
100984|NCT02245490|"~     Study to evaluate the efficacy of tamsulosin on storage symptoms and detrusor motor activity~     in patients with LUTS suggestive of BPH and relevant storage symptoms~   "
100985|NCT02245477|"~     In this study we explore To explore the role of maternal serum vascular endothelial growth~     factor (VEGF) in pregnancies complicated by foetal growth restriction.~   "
100986|NCT02245464|"~     The objective of this PMS study was to monitor and assess the safety of Micardis tablets in~     patients with hypertension over a period of 6 years~   "
100987|NCT02245451|"~     The primary objective of this study is to characterise the effects of tipranavir 500 mg and~     ritonavir 200 mg (TPV/r; given twice daily) at steady-state on the pharmacokinetics of~     methadone administered as a single dose in healthy adult volunteers~   "
100988|NCT02245438|"~     Study to characterize the effects of two dose combinations of Tipranavir (TPV)/Ritonavir~     (RTV) (TPV 750 mg/RTV 200 mg and TPV 500 mg/RTV 100 mg), administered twice-daily, on the~     pharmacokinetics of Norethindrone-Ethinyl Estradiol (NET/EE) 1 mg/ 0.035 mg administered as a~     single dose.~   "
100989|NCT02245425|"~     This study is designed to compare the short-term effects of two different thoracic spine~     thrust manipulation techniques on neck range-of-motion, pain, and self-reported disability in~     people with neck pain.~      The null hypothesis is that there will be no differences between the two manipulation~     techniques for short-term effects on neck range-of-motion, pain, and self-reported disability~     in people with neck pain.~   "
100990|NCT02245412|"~     The objectives of this trial were to evaluate the safety, tolerability,~     pharmacokinetics/pharmacodynamics (PK/PD) and efficacy of intravenous (IV) ALXN1007 in~     subjects with acute graft-versus-host disease (GVHD) of the lower gastrointestinal (GI)~     tract.~   "
100991|NCT02245399|"~     The purpose of the study is to assess whether a Mediterranean-type weight-loss diet, enriched~     with canola oil, high in plant protein, and low in carbohydrates will produce blood sugar~     control, reduce coronary heart disease (CHD) risk factors and maximize weight loss, better~     than conventional higher carbohydrate diets in overweight diabetic patients.~   "
100992|NCT02245386|"~     To evaluate levator ani muscle morphology following normal vaginal delivery and cesarean~     section (elective and emergent), using three-dimensional (3D) transperineal ultrasound, and~     to study the effect of mode of delivery on female sexual function.~   "
100993|NCT02245373|"~     Major Depression (MD) is highly prevalent and has associated a high burden and economic~     costs. Mild levels of MD could be treated without antidepressants at Primary Care (PC).~      Main objectives: 1) To calculate the cost-effectiveness of active monitoring (recommended by~     NICE) vs pharmacological antidepressant treatment to treat mild MD at PC level.~      Methods: 300 patients (≥18 years) with MD (diagnosed by the GP) will be recruited at the PC~     center. Depending on the level of symptoms, the GP will choose between: A) Active Monitoring~     (n=150) and B) pharmacological treatment (n=150).~      Patients will be followed-up for one year and data will be collected at baseline, 6 and 12~     months. Severity will be assessed by Patient Health Questionnaire (PHQ-9), quality of life~     with the EuroQoL-5D (5 health dimensions), and the use of services with an adapted version of~     the Client Service Receipt Inventory (including lost productivity).~      Cost-effectiveness and cost-utility analysis will be calculated and 5000 bootstrapping~     replications will be conducted to asses uncertainty. Cost-acceptability curves will be done~     using two perspectives: the National Health Service perspective and the Societal perspective.~      The Propensity Score technique will minimize the absence of randomization, matching cases~     from both treatment options.~   "
100994|NCT02245360|"~     To investigate the immunologic effects and safety of 60-day treatment of the Standardized~     Quality units (SQ) grass Sublingual immunotherapy (SLIT)-tablet in adult subjects with grass~     pollen-induced allergic rhinoconjunctivitis in a double-blind, placebo-controlled study.~   "
100995|NCT02245347|"~     Drug resistant tuberculosis is a growing problem world wide. The current methods for~     diagnosis are time consuming and may delay diagnosis and treatment for many weeks. In this~     study the investigators wish to take sputum samples from patients to see if the investigators~     can validate a molecular DNA based process for prompt identification of drug resistant~     tuberculosis. The investigators wish to extract and amplify DNA from drug resistant~     tuberculosis and identify genes within it that confer resistance.~   "
100996|NCT02245334|"~     To assess the effect of povidone-iodine on infectious complication rate caused by transrectal~     prostate biopsy~   "
101009|NCT02245165|"~     The aim is to elucidate how NO works in conjunction with other neurotransmitters to regulate~     the migrating motility complex (MMC). Twenty-two healthy volunteers should undergo~     water-perfused antroduodenojejunal manometry during a control period of 4 h, followed by~     another 4h after a bolus injection of either saline or the NO synthase inhibitor~     NG-monomethyl-L-arginine (L-NMMA, 10 mg/kg intravenously) with or without atropine (1 mg) or~     ondansetron (8 mg). Effects on the MMC pattern are determined. Exhaled and rectal NO is~     monitored throughout the experiments. Effects of L-NMMA on the MMC pattern are analyzed~     against a background of atropine or ondansetron. Blood samples are drawn for analysis of~     simultaneous peptide hormone release into the bloodstream. Peptide hormone release will be~     correlated to the respective motility pattern elicited by LNMMA.~   "
101077|NCT02244281|"~     1. To study the symptomatic improvement in LUTS afforded by FLOMAX® capsules, 0.4 mg daily~          compared to placebo, in female patients with lower urinary tract symptoms (LUTS) with a~          significant component of voiding symptoms~        2. To study the improvement afforded by FLOMAX® capsules versus placebo, in this patient~          population, in quality of life~        3. To assess the safety and tolerability of FLOMAX® capsules, 0.4 mg compared to placebo,~          in women suffering from LUTS with a significant component of voiding symptoms~   "
100997|NCT02245321|"~     The prevalence of iron deficiency in blood donors has been demonstrated to be a direct~     consequence of repeat blood donations. Given the adverse effects of iron deficiency, it is~     priority to implement programs to remediate iron deficiency issues associated with blood~     donations. To explore this issue, the study's aims to:~        1. Determine whether regular blood donors provided with accurate information about their~          iron status and written recommended courses of action will take steps to~          prevent/mitigate iron deficiency on their own without being given iron supplements by~          the blood center; and~        2. Determine if two different amounts of iron provided by the blood center will~          prevent/mitigate iron deficiency in regular blood donors.~      To conduct this randomized, placebo controlled study, participant donors will be assigned to~     one of two arms and followed for a 24 month period. Each subject will provide additional~     blood samples of 7 ml and 4.5 ml at each study visit for the purpose of tracking hemoglobin~     (Hgb), ferritin, soluble transferrin receptor (sTfR), and hematology laboratory results.~      Under the two study arms, subjects are to be randomized into one of the following five~     blinded categories:~        -  Receive a thank you letter after each blood donation.~        -  Receive a letter informing them of their ferritin result at each visit, along with~          recommendations for blood donation.~        -  Receive pills to take daily that contain no iron (a placebo or inert pill).~        -  Receive pills to take daily that contain 19 mg of iron (the typical amount in a~          multivitamin with iron).~        -  Receive pills to take daily that contain 38 mg iron (the typical amount in an~          over-the-counter iron supplement).~   "
100998|NCT02245308|"~     The goal of this research study is to examine the effects of a treatment for helping homeless~     veterans who smoke to stop smoking. Participants in the study will be assigned to one of two~     study groups. Participants in the first group will be referred to the local Department of~     Veterans Affairs Medical Center's Smoking Cessation Clinic for treatment. Second group~     participants will receive a behavioral treatment designed to reward smokers for quitting and~     staying quit. These participants will also receive telephone counseling and medications for~     smoking cessation.~   "
100999|NCT02245295|"~     There is a paucity of data concerning the impact of the sedation technique used for~     endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) on diagnostic~     accuracy. The aim of this retrospective study is to compare diagnostic accuracy of EBUS-TBNA~     in deep and moderate sedation, and to investigate other possible determinants of diagnostic~     accuracy in three lymph node locations (mediastinal, subcarinal, and hilar).~      The first consecutive patients at the University Hospital Zurich undergoing EBUS-TBNA for~     selective sampling in deep sedation are compared with the first consecutive patients in~     moderate sedation between 2006 and 2014. Diagnoses based on EBUS-TBNA were compared with~     those on surgical or radiological follow-up.~   "
101000|NCT02245282|"~     Prostate cancer detection and disease progression monitoring relies on systematic multi-core~     biopsies. Minimal invasive imaging capacities for lesion targeting and monitoring are badly~     needed. The purpose of this study is to determine if a new MRI technique can identify and~     monitor prostate disease progression. If so biopsy core number can be reduced to as small as~     one, and frequency for biopsy repeat can be reduced. The new technique is about a new way of~     analyzing the pictures taken as part of prostate MRI exam. This part is called dynamic~     contrast-enhanced MRI. It involves an injection of contrast reagent (or dye) through the arm~     vein during a time period when prostate MRI pictures are continuously taken.~   "
101001|NCT02245269|"~     Study to determine the effects of combined tipranavir and ritonavir treatment (at~     steady-state) on the single-dose pharmacokinetics of atorvastatin, the effects of single-dose~     atorvastatin on the steady-state pharmacokinetics of tipranavir, and the effects of antacid~     on the pharmacokinetics of tipranavir~   "
101002|NCT02245256|"~     To test the effect of low-dose dexmedetomidine for lowering the incidence of postoperative~     delirium in liver transplant patients in the ICU.~      Single center prospective randomized placebo controlled clinical trial 0.1mcg/kg/hr of~     dexmedetomidine or equivalent amount of saline infusion started after induction of anesthesia~     for liver transplantation and continued until 48 hours after surgery.~      Outcomes will be assessed up to 1 week or transfer to ward, whichever comes first.~   "
101003|NCT02245243|"~     The purpose of this study is to evaluate the pharmacokinetic profile, safety, and~     tolerability of a single intravenous (IV) dose of delafloxacin in normal healthy subjects and~     subjects with mild, moderate, or severe hepatic impairment.~   "
101004|NCT02245230|"~     The purpose of this study is to better understand the cardiovascular effects of the~     vasodilatory peptide Angiotensin (1-7) in human hypertension. In this study, the~     investigators will test the hypothesis that systemic Angiotensin (1-7) infusion produces~     negligible effects with intact baroreceptors, and that the cardiovascular effects of this~     peptide are unmasked following elimination of baroreflex buffering.~   "
101005|NCT02245217|"~     Study of multi-tracer PET scans to assess response to gemcitabine in pancreatic cancer~   "
101006|NCT02245204|"~     The purpose of this study:~      Determining the Maximum Tolerated Dose (MTD), Dose-Limiting Toxicity (DLT), pharmacokinetics~     characteristic, and dosage regimen of phase II/III of Chlorogenic acid for injection in the~     advanced malignant tumor subjects;~   "
101007|NCT02245191|"~     It is a prospective clinical trial with random distribution that intends to investigate~     maternal and fetal effects of ephedrine, phenylephrine and metaraminol during cesarean~     delivery in patients with pre-eclampsia.~   "
101008|NCT02245178|"~     Chronic obstructive pulmonary disease (COPD) is the third leading cause of death in the~     United States, but markers that predict risk of developing disease outside of cigarette~     smoking have not been identified. Individuals with lung disease frequently have concurrent~     cardiovascular disease, but the reason for this is not well understood. In this study, we~     will identify markers that predict risk of future lung disease and evaluate the concurrent~     subclinical evolution of lung and heart dysfunction. This will allow for targeting of~     preventive strategies to stop the rising incidence of COPD and other lung diseases and~     provide insights into why heart and lung disease frequently occur together.~   "
101026|NCT02244944|"~     The purpose of this research is to gather information on the combination Zetia® (Ezetimibe)~     and Urso Forte® with respect to sterol balance and their effects on biomarkers of liver~     function in subjects with nonalcoholic fatty liver disease (NAFLD).~   "
101010|NCT02245152|"~     Globally, child undernutrition is the underlying cause for 3.1 million deaths of children~     younger than 5 years. 18.7 million children under five years of age suffer from severe acute~     malnutrition (SAM) and an additional 33 million children suffer from moderate acute~     malnutrition, and are at risk of developing SAM~      In Sub-Saharan Africa, there is often poor integration between programs to treat child acute~     malnutrition and programs that focus on the prevention of acute and chronic undernutrition -~     resulting in many missed opportunities for using prevention platforms to screen and refer SAM~     children, or for using screening and referral platforms to provide prevention services.~      This project will address two critical gaps related to the integration of preventive and~     treatment programs: 1) screening and treatment of MAM/SAM have not yet been systematically~     integrated into routine health-center visits or mainstreamed into community outreach~     programs; and 2) screening programs often do not offer any preventive services for those~     children found not to be suffering from MAM/SAM at the time of screening; mothers of children~     identified as non-MAM/SAM case are usually sent home without receiving any health or~     nutrition inputs and as a result, may fail to come back for screening because they do not see~     any tangible benefit associated with their participation in the screening. This project will~     specifically address these gaps by assessing the effect of an integrated approach consisting~     of higher screening coverage and preventive Behavior Change Communication (BCC) +~     Small-Quantity Lipid-based Nutrient supplementation (SQ-LNS) on both prevention and treatment~     of child undernutrition.~   "
101011|NCT02245139|"~     Acute gastroenteritis is a common cause of hospital admission and health office visits and~     have a huge burden on the economy of developing countries. The investigators proposed this~     observational prospective study during summer period in a community and tertiary care~     hospital in a rural area of Lebanon to investigate the etiologies and age distribution of~     admitted cases to general pediatric floor from the age of 1 month up to the age of 14 years.~   "
101012|NCT02245126|"~     Using routinely collected data to compare different concentrations of locally applied~     anaesthetic drugs and determine which concentrations give better pain control during~     voluntary medical Male circumcision.~   "
101013|NCT02245113|"~     This study will be comparing human body responses by the effects of diets cooked with~     NoveLin, virgin olive oil and RBD coconut oil.~   "
101014|NCT02245100|"~     This pilot research trial studies circulating tumor deoxyribonucleic acid (DNA) in predicting~     outcomes in patients with stage IV head and neck cancer or stage III-IV non-small cell lung~     cancer. Studying circulating tumor DNA from patients with head and neck or lung cancer in the~     laboratory may help doctors predict how well patients will respond to treatment.~   "
101015|NCT02245087|"~     The purpose of this study is to determine whether pharmacologic lowering of low density~     lipoprotein cholesterol (LDL), initiated in healthy young to middle aged adults can eliminate~     or markedly reduce the composite endpoint of incident all cause mortality, myocardial~     infarction, stroke or coronary revascularization.~   "
101016|NCT02245074|"~     -  Background: Infantile asthma is composed of various phenotypes, however the definition~          is still based on the clinics. Namely, the infants could be classified as transitory,~          peristent or late and persistent asthma. Some risk factors for the persistent asthma~          phenotype are recognized as atopy. However all peristent asthma are not related to~          atopy. Regarding the pathophysiology, little is known on airways inflammation in these~          infants, and the current data are mostly based on the BAL analyses, or on biopsies.~          Consequently, BLA and biopsies should be justified by the need of an indicated~          fiberbronchoscopy, and therefore limited to severe infantile asthma. Airway secretion~          could be also collected after hypertonic saline induction and chest physiotherapy. This~          method has been validated in the children, but has not in the younger.~        -  Aim : Analyses of cell profiles regarding the severity of infantile asthma.~        -  Methods : This descriptive study compared 3 groups of infants, the first with acute~          exacerbation, the second with uncontrolled asthma and the third with controlled asthma.~          Accounting 25% of failure, the number of 40 infants per groups has been calculated. The~          sputum induction will be performed by repeated nebulizations of 3% saline hypertonic~          solution. Cellularity and cell profiles were analysed as previously recommended. Safety~          will be evaluated.~        -  Inclusion criteria : Any infants suffering of infantile asthma (at least 3 episodes of~          wheezing during the 2 first years of life), aged between 6-12months.Asthma control was~          evaluated on the last 4 weeks, allowing to classify the infants . Control asthma was~          aimed when neither exacerbation nor persistent symptoms were observed. Uncontrolled~          asthma was defined whether the infant presented any symptoms during the last 4 weeks.~          Exacerbation was defined as any acute symptoms, as cough, dyspnoea or wheezing.~        -  Feasibility : A preliminary study has been presented in the Vienna ERS congress.~   "
101017|NCT02245061|"~     The identification of the epileptogenic zone (EZ) during pharmacoresistant focal epilepsy~     presurgical assessment frequently requires intracranial recordings like~     stereo-electroencephalography (SEEG). Cortical direct electrical stimulation (DES) is~     commonly used during SEEG for functional mapping or to induce seizure.~      However, the recording of seizures is sometimes insufficient to circumscribe the EZ and~     development of new biomarkers is necessary.~      The cortex within the EZ is thought to be hyperexcitable. The paired pulses paradigm, using~     transcranial magnetic stimulation (TMS), allows determining the hemispheric cortical~     excitability level. The investigators hypothesize that paired pulses DES during SEEG could~     provide useful information for EZ identification.~   "
101018|NCT02245048|"~     The purpose of this research study is to determine if carotid artery ultrasound scanning can~     provide additional information for determining cardiovascular risk in patients.~      Patients who agree to participate wil undergo non-invasive carotid intima-media thickness~     (CIMT) measurement and plaque assessment. Findings of CIMT will be compared to results of~     patient standard of care stress echocardiogram (SE) and of diastolic function.~      We hypothesize tht 1) in patients undergoing SE for inappropriate or uncertain indications,~     CIMT and plaque assessment will provide useful risk stratification beyond use of traditional~     risk factors; 2) CIMT findings will correlate with results of SE in terms of exercise~     capacity and 3) Exercise capacity will correlate with diastolic function.~   "
101019|NCT02245035|"~     The purpose of this study is to learn if dairy food consumption may help brain health in~     aging by protecting nerve cells from oxidative damage.~   "
101027|NCT02244931|"~     The purpose of this study is to compare three assisting devices to propel personal~     wheelchairs (Servomatic A©, Servomatic B© and E.Motion©) to the standard personal manual~     wheelchair in patients with spinal cord injury.~   "
101028|NCT02244918|"~     The researchers are testing if counseling alone or counseling plus over-the-counter nicotine~     replacement therapies (NRT), like the patch,gum, or lozenge, helps African American non-daily~     smokers quit smoking.~   "
101142|NCT02243436|"~     Phase I trial aimed to determine the Maximum Tolerable Dose of the BV in combination with~     ESHAP in relapsed/resistant Hodgkin Lymphona patients and to evaluate response to treatment~     with BV-ESHAP as salvage regimen prior to autologous stem cell transplantation.~   "
101020|NCT02245022|"~     Aim: To evaluate dolutegravir (DTG) pharmacokinetics in pregnant HIV-infected women~      Rationale: In developing countries many women present with a new HIV diagnosis in late~     pregnancy, and are at high risk of transmitting infection during delivery. Moreover, women~     may acquire NNRTI resistance from primary transmission, or use of nevirapine (NVP) in~     previous pregnancies. In these circumstances, DTG is likely to be more effective in reducing~     mother to child transmission of HIV than NNRTI-based regimens.~      Study design: HIV positive pregnant women presenting with untreated HIV infection in late~     (≥28 -36 weeks gestation) pregnancy will be randomised 1:1 to receive DTG (50mg once daily)~     or standard of care (nevirapine or efavirenz) + 2 NRTIs. PK (0-24h) profile will be sampled~     in third trimester and post-partum.~      Although this is primarily a PK study (and has been powered as such) randomisation is~     included to allow comparison of plasma HIV VL responses against standard of care (NVP or EFV)~     and is essential for evaluation of secondary endpoints of safety and efficacy of DTG in~     pregnancy.~      Number recruited N=30 per group~   "
101021|NCT02245009|"~     Arrhythmias of the atria of the heart are a common comorbidity in patients with cardiac~     rhythm management devices, such as pacemakers and implantable cardioverter/defibrillators~     (ICD). External electrical cardioversion is an established method to achieve rhythm control~     (restore normal sinus rhythm) in patients with atrial arrhythmia. Little data on safety and~     efficacy of external electrical cardioversion in patients with cardiac rhythm management~     devices exists. Thus, available data on the safety of external electrical cardioversion in~     cardiac rhythm management patients lacks statistical power to accurately reflect the true~     hazard of external electrical cardioversion in patients with cardiac rhythm management~     devices.~      The aim is to systematically include and follow all patients with cardiac rhythm management~     devices presenting for external electrical cardioversion, to analyse the effects of external~     electrical cardioversion on leads and devices.~   "
101022|NCT02244996|"~     Objectives: To study the immediate effect and the persistent effect of Lycium barbarum (LB)~     treatment on retinal functions, especially the cone function, and retinal structure in~     patients with retinitis pigmentosa (RP) Design: Randomised controlled double-masked trial~      Setting: Primary Care clinical trial~      Participants: 120 RP subjects will be recruited from Ophthalmology department at The~     University of Hong Kong and the Retina Hong Kong. Interventions: Subjects will be randomly~     allocated to LB (treated with LB granules) or control (treated with placebo) groups for 1~     year. After the 1st year, both groups will stop the treatment and all subjects will also have~     the same eye exam in 6-month period for the 2nd year.~      Main outcome measures: The primary outcome is the total sensitivity scores of 30-2 & 60-4~     programmes of Humphrey Visual Field Analysis (HVFA). The secondary outcomes are the b-wave~     amplitudes of Full-field Electroretinogram (ffERG) responses, the amplitudes of direct~     component and induced component of Multifocal Electroretinogram (mfERG), and the ETDRS visual~     acuity.~      Results: Lycium barbarum treatment provides the immediate effect and the persistent effect on~     retinal functions and structure in patients with retinitis pigmentosa to improve the cone~     activity. It does not cause any harmful effect to the subjects.~      Conclusion: Cone rescue is an alternative approach to save the vision for RP patients. The~     result of this study will provide valuable information for the treatment of RP. The~     antioxidative effect of LB is believed to delay or minimize the cone degeneration in RP and~     the intake of LB will be a very economic way in the RP treatment.~   "
101023|NCT02244983|"~     It is the investigators goal to identify the prevalence of underlying diseases, make~     disposition more rational, and establish risk stratification tools in elderly patients~     presenting with falls. Additionally, the outcome of standard care (clinical assessment only~     for disposition) will be compared with a new approach combining the standard of care with~     biomarker assisted disposition of elderly patients presenting with falls. Therefore the~     investigators are looking at the following points.~      Emergency department work-up~        1. Prevalence of underlying disease~        2. Developing algorithms for initial assessment Disposition~      a. Establishing biomarker enhanced disposition planning by using risk-stratification tools b.~     Comparing geriatric emergency assessment to standardized disposition planning~   "
101024|NCT02244970|"~     Depressive mood and anxiety are prevalent in patients suffering from early psychosis.~     Treatments focused on these dimensions are rarely seen. Meanwhile, growing evidence showed~     Mindfulness-based intervention (MBI) as an effective option in handling depression and~     anxiety. There is a great possibility that MBI is also useful in depression and anxiety~     associating with early psychosis. Given that cost-effectiveness is widely concerned in Hong~     Kong or any other countries, a brief intervention is more favored. Current paper is a study~     protocol for a randomized controlled trial which assess the feasibility of a 7-week~     mindfulness-based intervention in patients with early psychosis targeting on their depressive~     mood and anxiety.~      In this RCT, 60 patients aged 18-65 with early psychosis less than 5 years' duration and mild~     depressive mood or anxiety will be invited to join this single blind randomized controlled~     trial. After baseline assessments, eligible participants will be, using third party simple~     randomization, randomly assigned to either the 7-week Mindfulness-based Intervention (MBI),~     or the psychoeducation group as control.~      The primary outcome is depressive mood and anxiety levels at post-intervention and 3 months.~     The secondary outcomes include life functioning, quality of life, other general clinical~     symptoms and mindfulness ability. Qualitative interviews will help evaluate and measure the~     feasibility of the intervention. Data will be analyzed according to the intention-to-treat~     principle.~      This randomized trial offers an insight into mindfulness-based intervention and its~     effectiveness on psychosis concomitants. It provides the foundation for future evaluation and~     implementation of an effective and cost-efficient treatment option.~   "
101025|NCT02244957|"~     The coexistence of chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea~     (OSA) in the same patient has been termed overlap syndrome, affecting 1% of the U.S.~     population.The investigators propose to conduct this study that aims: (1) to compare right~     and left ventricular hemodynamic parameters using cardiac magnetic resonance imaging (MRI) in~     overlap syndrome vs. COPD only and OSA only; (2) to compare the effects of bi-level positive~     airway pressure (BPAP) vs. nocturnal oxygen therapy (NOT) on right ventricular (RV)~     hemodynamics in overlap syndrome.~      This study will allow us to test the hypothesis: (1) Patients with overlap syndrome have more~     RV dysfunction than those with COPD only or OSA only; (2) treatment of both hypoxemia and~     hypercapnia during sleep will improve RV hemodynamics compared with treatment of hypoxemia~     alone in patients with overlap syndrome.~   "
101029|NCT02244905|"~     Healthcare-associated infections (HAI) are a significant public health burden. Even with~     existence of recommendations on technical strategies to prevent these infections, there is a~     need for strategies to increase staff engagement within the local organizational and cultural~     context. Positive deviance is one such approach that engages people in improvement efforts.~     Positive Deviance is based on the observation that in every community there are certain~     individuals or groups whose uncommon behaviors and strategies enable them to find better~     solutions to problems than their peers, while having access to the same resources and facing~     similar or worse challenges. In the proposed study, the investigators plan to test the~     effectiveness of using positive deviance based horizontal infection prevention approach to~     achieve overall reduction of HAIs among hospital inpatients. The investigators hypothesized~     that a broad and horizontal approach to reduce opportunities for acquisition of nosocomial~     pathogens using PD will lead to greater reduction of HAI among hospital inpatients compared~     to standard-of-care infection control approach. The investigators objective was to test the~     investigators hypothesis and evaluate whether there is greater decline in rate of HAI in the~     experimental group of wards compared to the control group of wards.~   "
101030|NCT02244892|"~     Disability glare is described as halos or starbursts around bright sources of light that~     can cause discomfort and reduce vision. The cornea is the clear window at the front of the~     eye, but certain conditions such as a previous infection can leave a scar. Corneal scars can~     cause disability glare by scattering and spreading incoming light instead of allowing it to~     focus on the back of the eye (retina) to get a crisp image. In this study, the corneal scar~     will be analyzed using a new device that measures scar density (Pentacam), and a relationship~     with disability glare will be made. This can help us further understand disability glare and~     make better decisions in the future on when to treat these scars to help patients see better.~   "
101031|NCT02244879|"~     This research will investigate the effect of resveratrol on inflammatory mediators in type 2~     diabetic patients in vivo.~      The investigators will also investigate the hypothesis that resveratrol has an antioxidant~     activity, improves insulin sensitivity and lipid pattern, down-regulates bone-turnover.~   "
101032|NCT02244866|"~     To compare the efficacy between LH supplementation (Pergoveris) and non-LH supplementation~     (Follitropin alpha) in patients aged ≥ 35 years undergoing IVF treatment.~      Study hypothesis: Pergoveris (LH supplementation) is better than follitropin alpha (non-LH~     supplementation) for ovarian stimulation in aged IVF patients.~   "
101033|NCT02244853|"~     The Cardiovascular disease research using Linked Bespoke studies and Electronic Records~     (CALIBER) e-health database was the data resource for this study. CALIBER links patient~     records from four different data sources: Clinical Practice Research Database (CPRD), MINAP~     (Myocardial Ischaemia National Audit Project registry) Hospital Episodes Statistics (HES),~     the Office for National Statistics (ONS).~   "
101034|NCT02244840|"~     Sitz bath is conventional and empirical remedy and commonly recommended for non-operative~     treatment of various anal diseases. However, as there was no substitute for sitz bath until~     now, the patients have to accept the inconvenience for treatment of their diseases.~      Electronic bidet is used with convenience as automatic device for cleansing the perineal~     area, especially after defecation. The similarity of contacting water to perineal area,~     clinical use of electronic bidet has been suggested for treatment of anal diseases. However,~     there had been few reports of clinical use of electronic bidet.~      Investigators performed the study to evaluate the effects of electronic bidet on anal resting~     pressure, compared to conventional warm sitz bath in normal healthy volunteers.~   "
101035|NCT02244827|"~     This study is aimed to compare the pharmacokinetics of levonadifloxacin and its sulfate~     metabolite after a single dose of oral WCK 2349 1000 mg in patients with hepatic impairment~     and healthy volunteers.~   "
101036|NCT02244814|"~     The rapidly rising risk of gestational diabetes pregnant women demands that an effective diet~     strategy be developed due to the high risk of fetal overgrowth, which places the newborn at~     increased risk for childhood obesity and metabolic syndrome. The aims of this randomized~     clinical trial are to compare the effects of an 8-wk isocaloric higher complex~     carbohydrate/lower fat diet vs. a conventional lower carbohydrate (higher fat) diet on~     glycemic and lipid profiles, maternal insulin resistance, placenta nutrient transporters, the~     maternal microbiome, neonatal intrahepatic fat, and neonatal total adiposity (primary~     outcome). The investigators will then follow the infants for 1-yr and measure maternal breast~     milk and infant microbiome composition to observe if they impact net fat mass gain~     differently in infants exposed to one diet vs. the other. Identifying a diet for gestational~     diabetes mellitus women that can effectively alter maternal/fetal metabolism is critical to~     reducing short- and long-term metabolic risk in this growing cohort of mothers and infants~     and has the potential to be applicable to overweight/obese pregnant women.~   "
101037|NCT02244801|"~     This Phase I pilot study will evaluate the safety, and tolerability of darTreg infusion for~     adult, de novo, living donor renal transplant recipients.~   "
101038|NCT02244788|"~     The purpose of this study is to allow patients to undergo surgery with the SR™ PIP (Proximal~     Interphalangeal) Implants for finger arthritis. This is NOT a research study, but rather, a~     requirement by the FDA for humanitarian use of device~   "
101039|NCT02244775|"~     The purpose of this study is to allow patients to undergo surgery with the SR™ MCP~     (Metacarpophalangeal) Implants for finger arthritis. This is NOT a research study, but~     rather, a requirement by the FDA for humanitarian use of device.~   "
101040|NCT02244762|"~     Determine the influence of renal impairment on the pharmacokinetics and metabolism of~     Hydrocodone Bitartrate Extended-Release (HC-ER) 20 mg capsules~   "
101041|NCT02244749|"~     The researcher can proved that certain compounds play an important role in the prevention of~     skin cancer. Researcher can use specific compounds, which classified as metabolic enzymes,~     and lower concentrations and complete absent in skin cancer cells. Researcher can biopsies of~     normal skin and precancerous or cancerous lesions, and can compare the concentrations of~     these compounds to determine the difference between the two areas. The result can lead to~     further understanding of skin cancers and pre-cancers. Because skin cancers and pre-cancers~     are so common, any knowledge would be very useful for many people in the future and may be~     used for development of future treatments or prevention strategies.~   "
112428|NCT02095873|"~     The purpose of this study is to determine whether dietary inducers of glyoxalase 1 are~     effective in improving metabolic and vascular health.~   "
101042|NCT02244736|"~     Arterial stiffness is associated with increased risk for cardiovascular disease. Moreover,~     the integrity of endothelial glycocalyx plays a vital role in vascular permeability,~     inflammation and elasticity. The association between damage of endothelial glycocalyx,~     impaired arterial elastic properties, and CFR in diabetics and first degree relatives has not~     been explored. The purpose of this study is to explore the association between damage of~     endothelial glycocalyx, impaired arterial elastic properties, and CFR in diabetics and~     first-degree relatives before and after during oral glucose tolerance test (OGTT).~   "
101043|NCT02244723|"~     Ventilator-associated pneumonia (VAP) is the most common nosocomial infection acquired by~     mechanically-ventilated patients in the intensive care unit (ICU). It has significant~     clinical and economic consequences, as it is associated with considerable morbidity,~     increased mortality, and excess health care costs. Appropriate antibiotic therapy for~     patients with VAP significantly improves outcomes, making rapid identification of patients~     with VAP an important clinical goal.~      This application is for support of a prospective, multi-centered study to evaluate the~     diagnostic value of lung ultrasound for VAP. The primary hypothesis is that the association~     of the Clinical Pulmonary Infection Score (CPIS) to specific lung ultrasound signs could~     allow for early and reliable diagnosis of bacterial VAP.~      Objective 1: To evaluate the sensitivity, specificity, and diagnostic accuracy of lung~     ultrasound alone and in association with the CPIS.~      Objective 2: To determine the frequency of specific lung ultrasound signs (subpleural~     consolidation, irregular B-lines) in VAP.~      Objective 3: To promote development of a diagnostic pathway for VAP incorporating CPIS, lung~     ultrasound, and unprotected tracheal aspirate (UTA).~   "
101044|NCT02244710|"~     Randomized clinical trial to assess the influence of treatment with ticagrelor or clopidogrel~     in the number of CECs (Circulating Endothelial Cells) and EPCs (Endothelial Progenitor Cells)~     in patients with ACS (Acute Coronary Syndrome), from baseline levels to chronic levels (1~     month).~   "
101045|NCT02244697|"~     Stridor is a respiratory noise caused by partial obstruction of the large airways at the~     level of the pharynx, larynx and/or trachea. The second most common cause of stridor is vocal~     cord paralysis.~      Awake nasolaryngoscopyn (ANL) is regarded as the gold standard for the diagnosis of~     laryngomalacia. However, ANL has some drawbacks as it may cause discomfort for the patient~     and the laryngeal view may be obscured due to patient movement or anatomical variations.~      Ultrasound (US) is a noninvasive, painless, radiation free, well tolerated imaging technique.~     Evaluation of the dynamic characteristics of the glottis by US revealed perfect reliability~     in comparison to nasolryngoscopy suggesting that US can be useful in the assessment of~     laryngeal adduction.~      The investigator hypothesize that laryngeal US can be an accurate and reliable adjunct in the~     diagnosis of functional and anatomical causes of stridor and dysphonia in the pediatric~     population.~   "
101046|NCT02244684|"~     An overwhelming body of evidence of the protective effect of folic acid supplementation on~     neural tube defect affected pregnancies led to mandatory folic acid fortification in Canada~     in 1998. Folate is an important co-factor in the transfer of one-carbon units essential in~     DNA synthesis, repair, and methylation reactions, aberrations of which have been implicated~     in the pathogenesis of several chronic diseases including cancer. Epigenetic reprogramming~     occurs in utero and has the potential to be modulated by the methyl donor supply of which~     folate is a contributor. Animal studies have shown maternal folate exposure can modulate~     epigenetic changes in the offspring, however, there is limited evidence of this relationship~     in humans. The aim of this research is to determine the effects of maternal dietary folate~     and supplemental folic acid intake during the periconceptional and in utero periods on global~     and gene-specific DNA methylation in human infants. This is a prospective observational study~     involving 368 Canadian mother-child pairs recruited from St. Michael's Hospital in Toronto,~     Ontario. Dietary and demographical information was collected from consenting pregnant women~     at study baseline (12-16 weeks gestation) and in the third trimester (34-37 weeks gestation).~     Maternal blood samples were obtained at baseline and prior to delivery and a sample of~     umbilical cord blood was collected at parturition to measure levels of folate status. Global~     and gene-specific DNA methylation in umbilical cord blood will be correlated with cord and~     maternal folate status. The data will be analyzed using separate ordinary least squares (OLS)~     regressions. Results from this study will contribute to a better understanding of how~     maternal folate and folic acid intake can modulate epigenetic modifications in the offspring~     and potentially have an effect on disease susceptibility later in life.~   "
101047|NCT02244671|"~     immobilization of yoked extra-ocular muscles in the anophthalmic orbit, in conjunction with~     platelet-rich-plasma, will improve integration of viable adipocytes injected into orbital fat~   "
101048|NCT02244658|"~     Chemotherapy-related myelosuppression usually occurs in AML patients, which induces severe~     thrombocytopenia and haemorrhage, a leading cause of death. This clinical trial aims at~     evaluating efficacy and safety of rhTPO in management of chemotherapy-induced~     thrombocytopenia in acute myelocytic leukemia.~   "
101049|NCT02244645|"~     This study may clarify a potential promising mechanism and clearest evidence to support the~     value of yoga as a therapeutic option for reducing chronic low back pain.~   "
101050|NCT02244632|"~     The purpose is to characterise the tolerability of Modufolin in combination with 5-FU alone,~     in combination with 5-FU and Oxaliplatin, in combination with 5-FU and Irinotecan and in~     combination with 5-FU, Oxaliplatin and Bevacizumab.~      Another purpose is to investigate 4 doses of Modufolin to identify the best dose for further~     assessment.~   "
101051|NCT02244619|"~     The purpose of the study is to evaluate post-op pain requirements in patients undergoing hip~     or knee replacement surgery who perioperatively receive either Oral acetaminophen or IV~     acetaminophen~   "
101052|NCT02244606|"~     The purpose of this study is to compare the safety, pharmacokinetics, and efficacy of oral~     SCY-078 vs. standard-of-care following initial intravenous echinocandin therapy in the~     treatment of invasive candidiasis.~   "
101075|NCT02244307|"~     The primary objective of this observational study was the assessment of prognosis factors for~     having recourse to prostatic surgery in patients with BPH who were administered class-1 alpha~     blockers. The secondary objectives were the assessment of the time from alpha-adrenergic~     blockade treatment initiation to surgery and the evolution of patients during the study.~   "
101076|NCT02244294|"~     To establish whether the administration of FLOMAX® improves the outcome of a trial without~     catheter (TWOC) after an episode of acute urinary retention and to determine whether~     spontaneous voiding is maintained over the course of six months of active treatment~   "
101078|NCT02244268|"~     The aims of this observational study are to identify the primary BPH symptoms responsible for~     the patients to consult a urologic practice, resulting in the prescription of ALNA®, to~     assess the clincial efficacy on an improved occupational performance of the patients being~     still employed. Additionally to obtain relevant information for the 5-year report of~     experience with this product according to the requirements in § 49, para 6 of the German~     Medicines Act.~   "
101053|NCT02244593|"~     Breast Magnetic Resonance Imaging (MRI) has been shown to be the most accurate test for~     detecting breast cancer however, MRI is not always reliable because it can indicate the~     presence of cancer when in reality, there is none; this is called a 'false positive' result.~     A history of breast carcinoma alone does not qualify a patient for ongoing monitoring with~     breast MRI. This study is being done to assess a new technique called FAST breast MRI. A FAST~     breast MRI is different than a traditional breast MRI because it has much fewer sequences and~     takes approximately 3 minutes for the scan. MRI sequences are combinations of magnetic pulses~     that collect information about the tissues. There is no radiation associated with an MRI.~      The purpose of this study is to determine the impact on patient health when a FAST breast MRI~     is used as a screening technique in women with a personal history of cancer. It has been~     shown that FAST breast MRI is similar to routine breast MRI in the detection of breast~     cancer, but it has not been proven that FAST breast MRI will help women who have a personal~     history for breast cancer. Currently, routine breast MRI is not part of the standard of care~     in screening for breast cancer in women who have a prior personal history of breast cancer.~     By evaluating FAST MRI the investigators are able to study the effects of this short MRI on~     cancer detection in women with a personal history of breast cancer, and on the impact on~     overall health. The investigators estimate that 300 participants will be enrolled in the~     study from The Ottawa Hospital Cancer Centre at The Ottawa Hospital, General Campus and the~     Women's Breast Health Centre at The Ottawa Hospital, Civic Campus. All of the participants~     have had a history of breast carcinoma.~   "
101054|NCT02244580|"~     This is a prospective examination of tumor material of breast cancer patients randomized into~     the FinHer-trial (= (= Comparison of vinorelbine and docetaxel and trastuzumab as adjuvant~     treatments of breast cancer patients wirh a high risk of cancer recurrence).~      The formalin-fixed, paraffin-embedded tissue samples will be analysed for Estrogen receptor 1~     (ESR1), progesterone receptor (PgR), Human epidermal growth factor receptor 2 (HER2) and~     Antigen Ki-67 (Ki-67) with the molecular in vitro diagnostic kit MammaTyper™.~      According to the new subtyping the 5 year Distant disease free survival (DDFS) and Overall~     survival (OS) will be re-evaluated.~   "
101055|NCT02244567|"~     High ucOC may favor insulin release in lean hyperandrogenic women to compensate for impaired~     insulin sensitivity. Meformin is an insulin sensitizing agent will be given for these women~     trying to interfere with the pathophysiology of PCOS in these women as followed up by serum~     UC-OC levels.~   "
101056|NCT02244554|"~     The purpose of this study is to evaluate the safety and efficacy of laser tattoo removal with~     picosecond pulse durations as compared to treatment with nanosecond pulse durations using a~     single novel Q-Switched (QS) Nd:YAG laser.~   "
101057|NCT02244541|"~     The primary objective of this Phase 2a study is to evaluate the maximal tolerated dose of~     ANAVEX2-73 in patients with AD in a repeated-dose administration scheme, with the secondary~     objectives being to explore the relationship between dosing regimen and pharmacodynamics~     efficacy outcomes and to evaluate the bioavailability of the oral form used and to explore~     the relationship of ANAVEX2-73 as add-on therapy to AD standard of care.~   "
101058|NCT02244528|"~     The purpose of this study is to investigate the pharmacokinetics of sildenafil which is used~     as treatment of pulmonary hypertension in neonate and preterm infant.~   "
101059|NCT02244515|"~     The purpose of this study is to determine whether dexmedetomidine is effective in the~     treatment of emergence deliruim after sevoflurane anesthesia in children with cerebral palsy.~   "
101060|NCT02244502|"~     The study is a prospective, single arm, non-randomized, open label pilot trial, designed to~     study the safety, toxicity, feasibility and preliminary efficacy of a medical device, the~     NovoTTF-100L(O) concomitant with weekly paclitaxel in recurrent ovarian carcinoma patients.~     The device is an experimental, portable, battery operated device for chronic administration~     of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor,~     by means of surface, insulated electrode arrays.~   "
101061|NCT02244489|"~     This study will evaluate the safety, tolerability, and define the maximum tolerated dose~     (MTD) of momelotinib (MMB) combined with capecitabine and oxaliplatin in adults with~     relapsed/refractory metastatic pancreatic ductal adenocarcinoma.~   "
101062|NCT02244476|"~     Dairy-based beverages contain fat and sugars. As both contribute to the energy intake upon~     consumption, food industry strives to reduce these ingredients while maintaining the taste,~     texture and aroma properties of the beverages. A successful reduction of fat and sugar from~     drinks has still proven a great challenge since consumers have less preference for the mouth~     feel of reformulated beverages than for the regular beverages. Mainly because instrumental~     measures like rheology and traditional tribology do not entirely predict the experienced~     mouth feel, there is an interest in alternative correlates for mouth feel aspects related to~     fat and sugar perception. In a recent study it was demonstrated that vibrations produced~     during interaction between the tongue, palate and beverages during consumption are very~     sensitive to the amount of fat and texturizers in the beverage. The present study aims at~     clarifying that relation for a larger panel of human subjects, by systematically evaluating~     vibration spectra during consumption of dairy beverages that differ in fat content, sugar~     content or pH. Secondly, the correlation of vibration spectra (acoustic tribology) with mouth~     feel-related sensory properties and composition of fat deposits on the tongue will be~     assessed.~   "
101063|NCT02244463|"~     This research study is studying a targeted therapy (ML0N128) as a possible treatment for~     anaplastic thyroid cancer.~      This research study is a Phase II clinical trial. Phase II clinical trials test the safety~     and effectiveness of an investigational intervention to learn whether the intervention works~     in treating a specific disease. Investigational means that the intervention is being~     studied. The FDA (the U.S. Food and Drug Administration) has not approved MLN0128 as a~     treatment for any disease.~      MLN0128 prevents tumor cells from dividing and growing by selectively and potently inhibiting~     a chemical, mTOR kinase, which regulates cell growth and survival. Patients with anaplastic~     thyroid cancer have been observed to sometimes carry genetic alterations in their tumor cells~     which may make the cancer more sensitive to inhibition by MLN0128.~      In this research study,the investigators are investigating usefulness of MLN0128 in~     metastatic anaplastic thyroid cancer cases.~   "
102988|NCT02219334|"~     The purpose of our study is to determine the safety, efficacy, length of stay and parental~     satisfaction of the NoseFrida in comparison to a suction device used in the hospital setting~     in patients with bronchiolitis admitted under observation status.~   "
101064|NCT02244450|"~     Severe combined Immunodeficiencies ( SCID ) are a group of inherited diseases of the immune~     system by characterised profound abnormalities of T cell development . Infants with SCID~     require prompt clinical response to Prevent life -threatening infection and studies show~     significantly improved survival in babies Diagnosed at birth as a result of previous family~     history . SCID follows criteria for population -based newborn screening since it is~     asymptomatic at birth and fatal within the first year of life, the confirmation of the~     disease is easy, there is a curative treatment , and it is known that early stem cell~     transplantation improves survival . Quantification of TRECs (T- cell receptor excision~     circles ) in DNA extracted from Guthrie samples is a sensitive screening test for Specific~     and SCID .~      The investigators propose in this study to perform a neonatal screening of SCID , in a~     population of 200,000 babies over a period of two years .~      The investigators propose to study the clinical utility and cost effectiveness ratio, and~     SCID screening to demonstrate that could result in a broad benefit to Individuals detected ,~     making screening relatively cost-effective in spite of the low incidence of the disease .~   "
101065|NCT02244437|"~     AMS (acute mountain sickness) affects those who ascend too high (>2000m) too fast.~     Acetazolamide is an effective drug for the prevention of AMS where proper acclimatization~     with gradual ascent may not be an option. AMS presents with headache and other non-specific~     symptoms such as nausea, tiredness, and dizziness. Because of the side effects of~     acetazolamide such as a tingling sensation, other drugs have been investigated to see if they~     will prevent AMS. Ibuprofen has recently been shown to prevent AMS. In this present study the~     investigators want to see if acetaminophen can also prevent AMS as acetaminophen unlike~     ibuprofen does not have gastric side effects. Second, because acetaminophen has much less~     anti-inflammatory component than ibuprofen, it may also provide some insight into the~     pathophysiology of AMS if acetaminophen were found to be effective in the prevention of AMS.~   "
101066|NCT02244424|"~     The purpose of this social media group randomized trial (GRT) is to test the feasibility of~     our Baby Dayr for Teen Moms intervention to increase maternal responsiveness to infant cues~     and implement healthy feeding practices through development of a healthy feeding style.~      Aim 1: Evaluate the feasibility and acceptability of the Baby Dayr intervention administered~     to the target population as it relates to their acceptance and satisfaction with the content,~     format, delivery, and use of social media.~      Aim 2: Explore efficacy of the Baby Dayr intervention administered to adolescent mothers of~     infants 4 months of age or less as assessed by maternal responsiveness, feeding style, and~     feeding practices evaluated at the completion of the intervention using self-report methods.~   "
101067|NCT02244411|"~     The EQUAL study has been designed for adult survivors of childhood acute lymphoblastic~     leukemia (ALL) who are overweight or obese. The purpose of this study is to see if diet and~     exercise can help people lose weight and improve other health problems. This two year study~     will compare two methods of informing participants about ways to lose weight.~   "
101068|NCT02244398|"~     The purpose of this study is to evaluate the feasibility and acceptability of adding HIV~     testing and counseling (HTC) services to the family planning (FP) services provided by~     community health workers in Uganda.~   "
101069|NCT02244385|"~     25-30% of women with preexisting vascular disease (chronic hypertension/diabetes/obesity)~     will develop pre-eclampsia and or growth restriction. In addition, the frequency of~     stillbirths in this group is dramatically increased over the general population. Pregnancy~     complications in this very heterogeneous group are likely to be a combination of a failure of~     the maternal vasculature to adapt to pregnancy and/or a failure of placental development. The~     relative contribution of these two mechanisms is poorly understood and current preventative~     strategies (aspirin) in this group only prevent a small number of adverse outcomes. This~     important and complex group have been inadequately investigated to date mainly because of the~     diversity of their underlying disease complicating prospective research studies.~      The evolution of tools which allow more detailed assessments of both uteroplacental blood~     flow and maternal vascular function will enable us to perform prospective studies in these~     women and to develop targeted preventative measures. Recent biomarker studies have also~     identified a number of biomarkers which have not yet been assessed in these high risk groups.~   "
101070|NCT02244372|"~     The investigators performed randomized, double-blind, placebo-controlled human trial to~     evaluate the efficacy and safety of Cordyceps sinensis mycelium culture extract (Paecilomyces~     hepiali, CBG-CS-2) on promotion of immunity. The investigators measured promotion of immunity~     parameters , including Cytotoxicity, Cytokine (IL-4, IL-6, IL-12, IFN-γ, TNF-α), hs-CRP,~     antibody titer, and upper respiratory tract infection(URI)~   "
101071|NCT02244359|"~     One of the toughest decisions faced by the frail elderly in Canada is whether to stay at home~     or move to a care facility. It is certainly difficult to make this decision alone, but can be~     even harder if someone else makes it for you. Shared decision making is when, instead of~     making decisions for the patient, healthcare professionals share information about what the~     evidence says, and they talk about what's important with the patient, and then make the~     decision together. In the case of the frail elderly in home care services, there are many~     health care professionals involved, e.g. the doctor, nurse and social worker. In this case~     decisions should be shared by all the professionals involved with the elderly person along~     with his or her caregivers. Unfortunately, in this context, shared decision making rarely~     occurs.~      We have designed a training program that teaches interprofessional teams how to share~     decisions with their frail elderly patients, and tested it in one Quebec City and one~     Edmonton home care team. This project tests the training program on a broader scale with 16~     home care teams attached to community health centres across the province of Quebec, and will~     compare the results with what happens when no one has completed the training (usual care).~     Home care is a rapidly growing sector and this study will lay the foundations for a national~     strategy to ensure that no one has to make this difficult decision alone.~   "
101072|NCT02244346|"~     Study to evaluate the safety profile of Secotex® in the improvement of the symptoms of Benign~     Prostatic Hyperplasia in real clinical practice~   "
101073|NCT02244333|"~     Study to assess efficacy, tolerability and safety parameters of a one month ALNA® - treatment~     after switch from Terazosin-treatment~   "
101074|NCT02244320|"~     The objective of the observational study were to investigate the switch from phytotherapy to~     ALNA® after at least 4 weeks of phytotherapy and still presented with a symptom sum score of~     ≥ 8 points (International Prostate Symptom Score (IPSS))~   "
101079|NCT02244255|"~     1. To study the early onset of symptomatic relief afforded by FLOMAX® capsules, 0.4 mg~          daily as compared to HYTRIN® capsules, 5 mg (with titration) daily in patients with the~          signs and symptoms of benign prostatic hyperplasia (BPH)~        2. To evaluate patient's tolerability to the use of FLOMAX® capsules 0.4 mg daily in~          comparison to HYTRIN® capsules, 5 mg (with titration) daily for the treatment of the~          symptoms of benign prostatic hyperplasia~   "
101080|NCT02244242|"~     Study to evaluate the symptomatic relief afforded by tamsulosin hydrochloride capsules in~     patients with signs and symptoms of benign prostatic hyperplasia (BPH). Additionally to~     provide primary care physicians experience with the use of tamsulosin hydrochloride capsules~     0.4 mg daily for the treatment of BPH~   "
101081|NCT02244229|"~     Study to evaluate the therapeutic effect of tamsulosin and finasteride in symptomatic BPH~     patients, two medications indicated in BPH belonging to two different pharmacological~     classes, as evaluated from the point of view of patient's perception of his pathological~     condition and of the impact of the disease on general health and quality of life~   "
101082|NCT02244216|"~     Study to obtain data about changing from the chlorofluorocarbon (CFC) - containing Berotec®~     200 µg metered - dose inhaler to the CFC - free Berotec® N 100 µg metered - dose inhaler~   "
101083|NCT02244203|"~     Single Rising Dose (SRD) study: First evaluation of safety, tolerability, pharmacokinetics~     and pharmacodynamics of BI 60732~   "
101084|NCT02244190|"~     To establish the bioequivalence of the new tipranavir oral solution formulation with the~     current tipranavir oral solution formulation following single-dose administration. In each~     case, 500 mg tipranavir was coadministered with 200 mg ritonavir.~   "
101085|NCT02244177|"~     Numbers of postoperative PCA related side effects among three groups will be determined by~     comparing and analyzing frequency distributions. To determine whether the patients with~     hypertension require less post operative opiate analgesics than others, multivariate analysis~     with repeated measures will be performed to identify the major and the minor factors~     predicting the use of postoperative pain therapy. The major aim of the study is to test the~     hypothesis that the morphine comsumpted by the hypertension group is less than those of the~     normotension group. The minor aims for the study are the difference related to pain~     intensity, or the incidence of side effects among groups.~   "
101086|NCT02244164|"~     Incretinomimetics and inhibitors of dipeptidyl peptidase-4 (DPP-4) are new treatments for~     diabetes. Previous retrospective studies have shown that these treatments induced an increase~     in pancreatic mass with potentially a risk for pancreatitis and development of precancerous~     lesions.~      The aim of our study is to provide a better understanding of the pathophysiological~     mechanisms of increased volume and / or pancreatic exocrine secretion when exposed to certain~     treatment of type 2 diabetes.~   "
101087|NCT02244151|"~     The aim of this study is to determine what is the best time interval between GnRH agonist~     (triptorelin acetate) ovulation induction allowing for the higher number of mature oocytes~     (MII) collected in IVF cycles.~   "
101088|NCT02244138|"~     Preventive care for adolescents is vitally important for maximizing their health and~     well-being. Unfortunately, pediatric primary care frequently fails to meet the preventive~     needs of adolescents as demonstrated by poor health outcomes for this population.~      In this grant application, the investigators propose to expand an existing computer decision~     support system (CDSS) into the investigators adolescent primary care practices for the~     purpose of implementing a comprehensive, and developmentally appropriate, screening and~     physician decision support process. Prior work completed by the investigators research group~     has demonstrated the feasibility of using CDSS to implement and evaluate clinical guidelines.~     The investigators seek to positively impact the effectiveness of preventative primary care~     visits by applying this previous success to the investigators adolescent practice. The~     investigators hypothesize that the implementation of developmentally appropriate universal~     screening practices, using tablet technology, and enhanced physician decision support~     regarding clinically relevant guidelines for all annual adolescent preventive care visits~     will result in better health outcomes, including higher rates of adherence to physician~     recommendations and improved patient functioning.~      The specific research aims of this proposal are:~      Aim 1: Expand and modify an existing CDSS to include an Adolescent Preventive Care Module~     comprised of developmentally appropriate screening tools for adolescents aged 11 to 21 years~     and tailored evidence-based clinical decision support for physicians.~      Aim 2: Evaluate the impact of the Adolescent Preventive Care Module on the identification of~     specific mental and physical health problems and treatment outcomes in an adolescent primary~     health care setting.~      Adolescent primary care issues of interest for this project include sexually transmitted~     infection (STI), depression, substance use and Human Papillomavirus (HPV) immunization. The~     investigators expect this project to improve the health outcomes of adolescents, guide future~     efforts to implement universal screening and CDSS in a variety of primary care settings, and~     provide additional evidence to support broad-based electronic screening and computerized~     decision support for use in preventive care as a method for improving adolescent health.~   "
101089|NCT02244125|"~     Imnovid in combination with dexamethasone is indicated in the treatment of adult patients~     with relapsed and refractory multiple myeloma who have received at least two prior treatment~     regimens, including both lenalidomide (Revlimid) and bortezomib (Velcade), and have~     demonstrated disease progression on the last therapy.~      Patients with relapsed and refractory multiple myeloma who have received bortezomib,~     lenalidomide, dexamethasone combination, considered to be the multiple myeloma optimal~     treatment, can access to pomalidomide under marketing authorization only as from third line~     of treatment.~      In France this combination is not authorized for marketing for a first line treatment and~     only patient randomized in the IFM/DFCI 2009 trial received it.~      This study concerns patients previously randomized in the IFM/DFCI 2009 trial who have~     received bortezomib, lenalidomide and Dexamethasone combination in first line, which at~     progression/relapse time therapeutic opportunities remained limited and who cannot access~     pomalidomide under marketing authorization.~      This study is a multicentre, phase 2, open label, study testing the triple combination of~     pomalidomide and cyclophosphamide and dexamethasone (PCD) in multiple myeloma patients who~     are refractory or in first progression/relapse after a first line treatment with bortezomib~     and lenalidomide, an IMiDs (an Immuno Modulatory Drug and a proteasome inhibitor) according~     to the IFM/DFCI 2009 trial.~      In the IFM/DFCI trial, patients in arm A received eight cycles of the~     Velcade-Revlimid-Dexamethasone combination followed by 1 year of lenalidomide maintenance,~     patients in arm B received 3 cycles of Velcade-Revlimid-Dexamethasone combination plus~     melphalan 200mg/m2 with an autologous transplantation followed by 2 cycles of~     Velcade-Revlimid-Dexamethasone combination consolidation and 1 year of lenalidomide~     maintenance.~      This study will contain 3 treatment phases:~        -  Study treatment phase:~      All patients will receive 4 cycles (28 days) of pomalidomide-cyclophosphamide-dexamethasone~     combination.~        -  Consolidation phase (depends on the initial randomization in the IFM/DFCI 2009 trial):~             -  For patients previously randomized in IFM/DFCI 2009's arm A:~                  -  Melphalan 200 mg/m2 followed by Autologous Transplantation~                  -  Three months after, 2 cycles of pomalidomide-cyclophosphamide-dexamethasone~                    combination~             -  For patients previously randomized in IFM/DFCI 2009's arm B:~                  -  5 cycles of pomalidomide-cyclophosphamide-dexamethasone combination~        -  Maintenance phase (identical to all patients) subsequent cycles of pomalidomide and~          Dexamethasone until progression / relapse or discontinuation for any other reason.~      For arm B patients, in case relapse occurs at least 12 months after the end of the~     maintenance IFM/DFCI 2009 trial, they could proceed to a second autologous transplantation~     and therefore follow the arm A procedure. The decision to proceed to a second transplant will~     be made by the physician and the patient.~      In order to have the same amount of patients enrolled in this trial in the initial Arm A and~     Arm B of the IFM/DFCI 2009 trial, once 50 patients have been included in either arm A or B,~     subsequent patients will be eligible if they have not been initially treated as the first 50~     patients from either arm.~      The primary endpoint is the response rate (Partial Response (PR) or better) after 4 cycles of~     the triple combination pomalidomide and cyclophosphamide and dexamethasone (PCD) in the~     studied population using International Myeloma Working Group (IMWG) response criteria.~   "
101090|NCT02244112|"~     The purpose of this Phase 1 of the study is to evaluate the effect of food on the~     pharmacokinetics (PK) of oprozomib, the drug-drug interaction of oprozomib with midazolam,~     and the safety and tolerability of oprozomib in patients with advanced malignancies~   "
101106|NCT02243904|"~     Study for Promotion of Health in Recycling Lead (SPHERL) is a prospective 2-year follow-up~     study of lead workers with exposure levels varying between and within individuals. SPHERL~     addresses to what extent between-subject differences or within-subject changes in lead~     exposure may have a measurable impact on blood pressure, the cardiovascular system, renal~     function, the autonomic nervous system, peripheral nervous conduction velocity, and~     neurocognitive function.~      At the beginning of December 2015, 70 participants were included in the study.~   "
101091|NCT02244099|"~     The purpose of this study is to characterize and improve controlled substance, carisoprodol~     and tramadol use in an internal medicine residents' clinic. Specific objectives of this study~     include:~        -  To measure the adherence to a controlled substance treatment agreement (CSTA) before and~          after implementation of a population management intervention~        -  To determine the number of patients on a CSTA with a discrepancy identified on a urine~          drug screen or an Ohio Automated Rx Reporting System (OARRS) report~        -  To track the number of patients on a morphine equivalent dose (MED) of ≥ 80 mg/day~          before and after implementation of a review intervention~        -  To characterize the healthcare utilization of patients taking controlled substances,~          carisoprodol, or tramadol by tracking the mean number of ED visits, hospital admissions,~          telephone calls, and clinic office visits during a 6 month period~   "
101092|NCT02244086|"~     Abstract.~      Epidural analgesia is the most safe and effective for the treatment of pain of childbirth~     method. Epidural Bupivacaine provided excellent analgesia for labor and remains the most~     widely used local anesthetic in obstetric anesthesia.~      Objective: To evaluate the analgesic efficacy of two concentrations of bupivacaine in women~     in labor.~      Methods: 114 patients were included in labor with term pregnancy. Were grouped randomly into~     two groups: patients who received bupivacaine 0.125 % (Group A) and 0.25% bupivacaine (group~     B). Patients in group A received 10 ml of 0.125% bupivacaine bolus. The patients in group B~     received 10 ml. Bupivacaine 0.25% bolus. Pain intensity according to VAS, blood pressure,~     heart rate, respiratory rate, degree of motor block was assessed using the Bromage scale at~     different periods of time.~      Results: Demographic characteristics and parity were compared, no statistically significant~     differences. By comparing the values of the VAS measure 0, 15, 30, 60 and 90 minutes into~     statistically significant differences in favor of the group with 0.25% Bupivacaine with~     decreased pain perception after 30 minutes, p-value found 0.02. No differences in arterial~     pressure, heart rate and respiratory rate were found between the two groups.~      Conclusion: The concentration of 0.25% Bupivacaine has greater analgesic efficacy compared~     with 0.125% bupivacaine.~   "
101093|NCT02244073|"~     During the last 2 decades, the management of hyperglycemia in critically ill patients has~     become one of the most discussed topics in the intensive-care field. The initial data~     suggesting significant benefit from the normalization of blood glucose levels in critically~     ill patients using intensive intravenous insulin therapy (Van den Berghe G et al. N Engl J~     Med. 2001) has been tempered by later studies (Finfer S et al. N Engl J Med. 2009). Some~     studies suggested that strict blood glucose control might benefit in non-diabetic patient and~     worsen outcomes in diabetics. We hypothesized that an individualized blood glucose target~     based on glycated hemoglobin measured at ICU admission would improve outcome when compared to~     a standard care of maintaining blood glucose bellow 10 mmol/l (180 mg/dl). We designed a~     randomized double blinded study in which Blood glucose control is piloted in both groups by a~     web-guided protocol that directly gives instruction to nurses~     (https://extranet.chu-lyon.fr/cpg). The study will enroll 4200 patients in 10 centers.~     Primary end point is 90 d outcome after randomization.~   "
101094|NCT02244060|"~     Objective measures of health are relatively expensive; meanwhile, self-reports are critiqued~     to be subjective and not comparable. A middle ground approach is to apply the frontier work~     of vignette methods. The aim of the survey experiment is to explore the validity of survey~     instruments to identify students who need glasses, using objectively measured visual acuity~     as a gold standard. It is hypothesized that direct comparison against vignette (DCV) is~     significantly different from indirect comparison against vignette (ICV); meanwhile,~     self-assessment of vision (SAV) is significantly different from primed self-assessment of~     vision (PSAV). It is also hypothesized that DCV is a more valid survey instrument than ICV to~     classify students who need glasses, using objective visual acuity as a gold standard. Lastly,~     it is hypothesized that priming effect from vignettes improves the validity of~     self-assessment. It is planned to enroll 3,755 subjects in the survey experiment.~   "
101095|NCT02244047|"~     Celiac disease (CD) is an immune-mediated systemic disease that is elicited by consumption of~     gluten and related prolamines in genetically susceptible individuals. Not only genetic but~     also environmental factors play an important role in CD pathogenesis. CD patients have~     imbalance in the gut microbiota, they have reduced number of Bididobacterium species in feces~     and biopsies.~      Up till now, only effective treatment for CD is life long adherence to gluten free diet. If~     gluten free diet is not strict that leads over the years to complications of disease, such as~     autoimmune diseases, psychiatric diseases, osteoporosis etc. That may be caused by continuous~     recirculation of activated immune cells between the inflamed organ and the periphery. To~     avoid complications of disease in long term the investigators want to test specific probiotic~     bacteria from Bifidobacteria genus, that has has been in vitro studies recognized as~     anti-inflammatory.~      Hypothesis~        1. Children with celiac disease on gluten free diet have a higher level of pro-inflammatory~          cytokine (TNF-alpha) and anti-inflammatory cytokine (IL-10) in comparison with healthy~          controls.~        2. 3 months after daily probiotic consumption TNF-alpha level decrease and IL-10 level~          increase.~      In the investigators research will be selected 70 children, age from 2 to 18 years, divided~     in different groups:~        1. Group: 25 children with celiac disease on GFD for at least 3 months and will receive~          probiotic for 3 months.~        2. Group: 25 children with celiac disease on GFD for at least 3 months and will receive~          placebo for 3 months.~        3. Group: 20 healthy children~   "
101105|NCT02243917|"~     This is a multicenter, open-label, Phase 1 study of orally administered CB-5083 in adult~     subjects with advanced metastatic solid tumors. The study will be conducted in 2 parts: an~     initial Dose Escalation Phase (Phase 1a) of CB-5083 in subjects with advanced metastatic~     solid tumors who have progressed or are non-responsive to available therapies and for which~     no standard therapy exists, followed by a Dose Expansion Phase (Phase 1b) which will include~     1 to 4 arms: one arm in subjects with RAS mutated mCRC; optionally, at sponsors discretion, 3~     additional arms may be added for subjects with advanced RCC, advanced pNET, or solid tumors~     with mutations in the RAS-MAPK pathway.~   "
101107|NCT02243891|"~     The study will test the hypothesis that ablation of paroxysmal atrial fibrillation in~     hypertensive subjects is more effective when a ROX coupler is inserted concurrently.~   "
104546|NCT02198950|"~     The purpose of this study is to determine wether the combined measurement of the soluble form~     of TREM-1, PCT and the determination of neutrophils CD64 expression could diagnose sepsis in~     critically ill patients.~   "
101096|NCT02244034|"~     Background: Postoperative hypothermia may result in relevant complications such as adverse~     cardiovascular events, wound infection, and coagulopathy with consecutive blood loss.~     Patients with open cardiac surgery using cardiopulmonary bypass are particular at risk for~     hypothermia. The study of Karalapillai and coworkers, analyzing a huge database incl. 43,158~     patients with CPB, revealed 66% of them experiencing postoperative hypothermia during the~     first 24 hours and 0.3% longer than that. During cardiac surgery great parts of body surface~     including wound surface are exposed. Many of these patients receive large amounts of~     infusions and transfusions, and undergo hemodilution during CPB, which may additionally~     contribute to development of hypothermia.~      Objective of the planned study is to find out incidence and duration of postoperative~     hypothermia and also risk factors for hypothermia in cardiac patients. Further objective is~     the incidence of postoperative complications and its relation to postoperative core~     temperature.~      Methods: A retrospective chart review 780 patients who had been underwent cardiac surgery~     with CPB Included are patients ≥ 18 years old. Excluded are patients with preoperative~     hyperthermia (> 37.8 °C) and hypothermia (> 36 °C).~      The following parameters will be recorded: temperature is measured at ICU after arrived and~     after 6 hours which is primary outcome, biometric data include age, sex, body weight, height,~     ASA physical status, surgical procedure includes emergency cases, anesthetic and surgical~     (bypass-) times, infusion/transfusion-regimen, blood loss and urine output, coolest~     temperature during bypass, method of temperature protection, and the outcome of operation .~      All data will be described in number and percent and Pearson chi-square method will be used~     for analyze correlation between hypothermia and risk factor . P-value <0.05 will be defined~     to significant.~   "
101097|NCT02244021|"~     A pilot phase II study with brentuximab vedotin as pre-ASCT induction therapy in~     relapsed/refractory Hodgkin's lymphoma patients non-responding to IGEV salvage treatment.~   "
101098|NCT02244008|"~     The purpose of this study is to verify the effect of anteroposterior talus mobilization on~     range of motion, pain, and functional capacity in participants with sub-acute and chronic~     ankle injuries.~   "
101099|NCT02243995|"~     Exercise intolerance, muscle weakness and fatigue complaints are frequent and persistent~     problems in sarcoidosis. These physical impairments are disabling and affect quality of life~     in a negative way. The aetiology of these physical impairments is multifactorial. Physical~     inactivity can cause deconditioning, resulting in more perceived fatigue and muscle weakness.~     These symptoms may be partially reversible following a structured physical training program.~     However, scientific studies about physical training in sarcoidosis are lacking. Therefore,~     the aim of the present study is to examine the changes in fatigue complaints, physical~     functioning and quality of life (QOL) in patients with sarcoidosis following a 13-week~     physical training program.~      After obtaining written informed consent, sarcoidosis patients will start a 13-week physical~     training program for three times a week. This training program includes peripheral muscle~     training for both the upper and lower extremities (starting at 40% of the multiple-repetition~     maximum) and endurance training consisting of walking on a treadmill (starting at 60% of the~     speed of the 6-minute walk test) or cycling on a ergometer (starting at 50% of the Wmax).~      Participants will be assessed at baseline (week 0), at the end (13 weeks) and 3 months after~     ending the training. During these assessments, patients perform muscle strength (m.~     quadriceps and m. biceps) and exercise tests (six-minute walk test and submaximal endurance~     cycling test). They also complete several questionnaires:~      Fatigue Assessment Scale (FAS), World Health Organization Quality of Life assessment~     instrument-BREF (WHOQOL-BREF), Small Fiber Neuropathy Screening List (SFNSL), Medical~     Research Council (MRC), Visual Analogue Scale (VAS) and Hospital Anxiety and Depression Scale~     (HADS)~   "
101100|NCT02243982|"~     The PET tracer Fluoro-ethyl-methyl-amino-naphthyl-ethylidene-malononitrile ([F18]-FDDNP) has~     a specific affinity for lesions containing tau protein and beta-amyloid The study consists of~     two phases~        -  In a first transversal phase, 8 neurologically unimpaired controls, 15 patients with PD~          and no dementia (PDND) and 8 with PD and dementia (PDD) will undergo lumbar puncture for~          study of tau, phospho-tau and beta-amyloid levels in cerebrospinal fluid (CSF), as well~          as positron emission tomography (PET) with ([F18]-FDDNP. Concentration of CSF markers~          and both the degree and topography of FDDNP-PET uptake will be compared among groups,~          along with correlation analysis between CSF and PET findings.~        -  During the second phase (18 months follow-up), the PDND patients will undergo the same~          procedures, and cognitive changes including incident dementia will be assessed. The~          correlation between cognitive impairment and neurochemical and neuroimaging changes will~          be established to determine the predictive value of these markers.~      Since the pathological lesions observed in Alzheimer disease (AD) are common in the PD and~     the concentrations of tau and beta-amyloid are altered in AD and PET with [F18]-FDDNP is able~     to separate patients with AD and cognitive impairment from controls, we hypothesized that:~        1. - Patients with PD will show a biomarkers profile similar to the AD (decreased levels of~          beta-amyloid and increased phospho-tau and tau) in CSF, and an abnormal uptake of~          [F18]-FDDNP PET compared to PDND patients and controls.~        2. -The distribution of cortical [F18]-FDDNP in the PD will be different from the AD and~          similar to dementia with Lewy bodies, predominantly in posterior cortical areas.~        3. PDND patients will show a [F18]-FDDNP PET uptake and levels of protein markers in CSF~          intermediate between controls and patients with PD.~        4. -In the subsequent follow-up, PDND patients will show cognitive impairment correlate to~          changes in the levels of protein markers in CSF and uptake of PET with [F18]-FDDNP~        5. - The predictive value for the development of dementia in PD of specific patterns of PET~          uptake and CSF proteins profile will be established.~   "
101101|NCT02243969|"~     Rationale: Increased intakes of n-3 long chain polyunsaturated fatty acids eicosapentanoic~     acid (EPA) and docosahexaenoic acid (DHA), mainly found in fatty fish, are recommended for~     the prevention of coronary heart disease. Alpha-linolenic acid (ALA, C18:3n-3) is the most~     common vegetable-oil based n-3 fatty acid. Evidence exists that ALA supplementation can also~     have a protective effect on the development on cardiovascular disease, but may exert its~     cardio protective effects through different routes. The benefit may (partly) be due to blood~     pressure lowering. However, evidence for beneficial effects of ALA on blood pressure is~     conflicting. Therefore, we propose to investigate the effect of flaxseed oil, high in ALA,~     using a study powered on 24-hour blood pressure, in a population with high normal blood~     pressure and mild hypertension.~      Objective: To study the effects of flaxseed oil, rich in ALA on 24h-ambulatory mean arterial~     pressure (MAP) in men and women with high-normal blood pressure and mild hypertension~     compared to high oleic sunflower oil, poor in ALA.~      Study design: Using a double blind randomized, placebo-controlled parallel design, subjects~     will receive at random daily 10 g of flaxseed oil or a high-oleic acid sunflower oil (HOSF)~     as control for twelve weeks, with a run-in period of 14 days in advance.~      Study population: 72 men and women, aged 40-70 years, with untreated high-normal blood~     pressure and stage I hypertension and a body mass index between 25 and 35 kg/m2 will~     participate in the run-in and intervention period. It is estimated that 144 subject have to~     be screened to find 72 subjects that will enter the run-in period.~      Intervention: During the run-in period, subjects will receive daily 10 g of palm super olein~     oil. During the intervention period subjects receive either 10 g of HOSF or flaxseed oil. All~     oils are provided in bottles of 5 g, one will be consumed at breakfast or lunch and one at~     dinner.~      Main study parameters/endpoints: The main study parameter is the change in 24h-ambulatory~     mean arterial pressure (MAP)~   "
101102|NCT02243956|"~     The purpose of this study is to investigate effects of a selected food product rich in~     polyphenol on cognitive performance and mood.~   "
101103|NCT02243943|"~     Suboptimal reversal of neuromuscular blockage after surgery is possibly related to~     unfavorable postoperative respiratory conditions and elevated pain levels. Rapid and complete~     reversal of neuromuscular block was not possible untill sugammadex was discovered. The~     investigators hyposthesise that reversal with sugammadex leads to favorable postoperative~     respiratory conditions and less pain compared to reversal with neostigmine.~   "
101104|NCT02243930|"~     The purpose of this study is to investigate the attachment of a transparent hood (cap) on~     the sigmoidoscope. The investigators hypothesis is that this will reduce pain, reduce~     investigation time, and increases the success rate of the sigmoidoscopy. The study focus on~     the less-experienced endoscopist.~   "
101108|NCT02243878|"~     This study investigates the use of radiation to treat wet age-related macular degeneration~     (AMD). The radiation is delivered using a robotically controlled device that projects~     overlapping beams of radiation onto the macula, the part of the eye that is affected by wet~     AMD. Participants will be randomized to receive radiation (stereotactic radiotherapy) or~     simulated placebo treatment (sham control). They will be followed up regularly for two years,~     and then again at the end of three and four years for a safety visit. Participants will also~     receive injections of ranibizumab (Lucentis) into their eye if their wet AMD is active.~     Ranibizumab is the standard anti-VEGF agent that is used to treat wet AMD. The study aims to~     determine if stereotactic radiosurgery can maintain vision and reduce the need for such~     regular anti-VEGF injections.~   "
101109|NCT02243865|"~     The purpose of this pilot study is to evaluate the performance of the Chordate System, in~     terms of the prophylactic effect and tolerability of treatment in patients diagnosed with~     migraine.~   "
101110|NCT02243852|"~     This study will recruit healthy controls (who have normal GH production and growth hormone~     levels) and patients identified as having GHD, who are deemed eligible for GH replacement~     therapy according to NICE guidelines. The patients recruited will have been identified as~     starting on GH by their referring clinicians and a decision made on their replacement therapy~     prior to their potential enrollment in the study. The study, or its research team, will have~     no influence on the decision as to whether a patient will start on GH, or on which of the~     many GH formulations that the patients receives. The proposed study is an observational study~     to determine how GH affects the plasma levels of Fibroblast growth factor 21 (FGF21) in~     response to treatment; and whether the change in FGF21 mirrors the improvement in body~     composition/fat deposition. FGF21 is a metabolic regulator that acts on multiple tissues to~     coordinate carbohydrate and lipid metabolism and regulate energy balance.~      We hypothesize that FGF-21 is expressed and secreted from liver and skeletal muscle in humans~     in response to growth hormone administration and that levels may be reduced in patients with~     GHD compared with healthy controls. Furthermore, we believe that the beneficial effects of~     long-term GH replacement on body composition (reduction in visceral adipose tissue,~     subcutaneous adipose tissue and liver fat), on improvement in lipid profiles and on skeletal~     muscle mitochondrial function involve GH-induced release of FGF21.~   "
101111|NCT02243839|"~     Prosthetic heart valve thrombosis is a serious complication with high mortality and morbidity~     The best treatment of PVT is controversial, although surgery and thrombolysis options have~     been available. In this randomized and multicenter study, the investigators compared~     thrombolytic therapy versus surgery for the treatment of patients with obstructive prosthetic~     valve thrombosis.~   "
101112|NCT02243826|"~     This study is designed to evaluate the analgesic effect of nitrous oxide (N2O) on the pain~     induced during lumbar puncture.~   "
101113|NCT02243813|"~     The current protocol is a pilot study of the effects and possible utility of~     psilocybin-facilitated experiences for professional religious leaders.~   "
101114|NCT02243800|"~     Vitamin D plays a key role in the regulation of calcium metabolism and bone physiology and~     also presents immunomodulatory effects. In contrast to healthy individuals, macrophages and~     synoviocytes synovium of patients with rheumatoid arthritis (RA) have receptors for vitamin~     D. In vitro, 1,25 Vitamin D inhibits T cell proliferation and cytokine synthesis and~     decreases pro-inflammatory process. There is an inverse relationship, at least in some~     epidemiological studies, between the circulating levels of 25OH vitamin D and the occurrence~     and / or activity of RA. The hypothesis of our study is that natural vitamin D~     supplementation in patients with RA and a vitamin D deficiency (vitamin D <30 ng / mL)~     improves functional disability.~   "
101115|NCT02243787|"~     This study is a randomised, double-blind, placebo-controlled, sequential, ascending~     single-dose, parallel group study to evaluate safety, tolerability, biological activity, and~     systemic exposure of COVA322 (tumor necrosis factor alpha (TNF-α) / interleukin 17 A (IL-17A)~     antibody fusion protein) in patients with stable chronic moderate-to-severe plaque psoriasis.~     Patients will receive ascending single-doses of COVA322 or placebo as a constant-rate i.v.~     infusion, followed by 12 weeks of evaluation.~   "
101116|NCT02243774|"~     The aim of this study is to determine whether receiving a core letter signed by the Surgeon~     General or the Director of the National Vaccine Program that provides only information about~     influenza, or a core letter signed by the Surgeon General with an added basic or enhanced~     implementation prompt, will increase rates of influenza vaccination among Medicare~     beneficiaries when compared to a control group.~   "
101117|NCT02243761|"~     Families of adolescents struggling with comorbid mental illness and addiction problems~     typically experience considerable emotional, financial and social burdens. Concurrent~     disorders (CDs) within families contribute to added stress and interpersonal conflict, as~     well as disrupt normal routines such as social and occupational activities. Despite the~     difficulties associated with being a family member of youth with CD, current mental health~     and addictions practices neglect to address this population. The overall purpose of this~     project is to assess the feasibility and clinical effectiveness of a Dialectical Behaviour~     Therapy skills (DBT) based training group for families of youth with CDs. The following main~     hypothesis will be examined: Family members of youth with concurrent disorders who~     participate in a 12-week skills group led by therapists and/or peer facilitators will show~     reduced caregiver burden and parenting stress from pre to post treatment.~   "
101118|NCT02243748|"~     This clinical trial studies a palliative care intervention in improving symptom control and~     quality of life in patients with stage II-IV non-small cell lung cancer and their family~     caregivers. Palliative care programs can provide patients and their caregivers with~     information on how to manage their symptoms, maintain health and well-being, and access~     supportive care services. An interdisciplinary palliative care model may effectively link~     lung cancer patients to the appropriate supportive care services in a timely fashion.~   "
101132|NCT02243566|"~     The purpose of the study was to examine the effect of six- to eight-week treatment with~     MicardisPlus® on blood pressure and the effect of patient self-monitoring on blood pressure~     control. In addition, the post-marketing surveillance study offered the possibility to obtain~     information about the influence on different laboratory parameters during treatment with~     MicardisPlus® from an unselected patient group under office conditions~   "
101119|NCT02243735|"~     The aim of this multicenter trial is to determine the efficacy of preoperative intravenous~     iron suppletion in comparison with the standard preoperative oral substitution in anaemic~     patients with colorectal cancer in curing the anemia and the assess the effect of~     preoperative iron on morbidity, postoperative recovery and quality of life.~      Hypothesis: It is our hypothesis that a more profound approach of preoperative anaemia with~     intravenous iron will lead to a higher percentage of patients with normalization of Hb-level~     (> 12 g/dl (7.5 mmol/l) for women and > 13 g/dl (8 mmol/l) for men), which potentially~     reduces morbidity, length of stay, improves quality of live, decreases fatigue and could be~     more cost effective compared to current practice with oral substitution of iron.~   "
101120|NCT02243722|"~     Laryngeal motor and sensory nerve dysfunction may cause phonation and swallowing disturbance,~     which often happens after the treatment for laryngopharyngeal and esophageal cancer and may~     induce fatal complications such as aspiration pneumonia. By the conventional examinations,~     the tiny sensory or motor changes are hard to be detected before complete vocal paralysis. It~     is utmost important to establish a comprehensive quantitative method which is sensitive~     enough to evaluate the neuromuscular functions. The present project will evaluate the~     laryngeal nerve function by quantitative laryngeal electromyography, which was developed by~     the research team, and another novel examination technique, mucosal membrane sensation test.~     The comprehensive method is expected to grade the laryngeal nerve injuries quantitatively~     before the significant symptoms or complications and can also help to evaluate the treatment~     effect from medicine, rehabilitation or surgery.~   "
101121|NCT02243709|"~     The goal of this study is to determine if, under stress, alcohol drinking is reduced using~     mifepristone~   "
101122|NCT02243696|"~     The purpose of this registry study is to confirm the long-term safety and reliability of the~     Protego DF4 right ventricular lead.~   "
101123|NCT02243683|"~     The purpose of this study is to determine the toxicity, tolerability and safety of single~     ascending doses of AX-024.HCl in healthy male subjects.~   "
101124|NCT02243670|"~     This study uses an artificial intelligence platform to automatically confirm medication~     ingestion. The Health Insurance Portability and Accountability Act (HIPAA)-compliant platform~     can be downloaded as an 'app' onto any smartphone to automate directly observed therapy~     (Automated DOT®). Real-time patient adherence data are encrypted and automatically sent to a~     centralized web-based dashboard for use by healthcare professionals or research staff. Unlike~     Facetime® or Skype®, the system relies on computer vision algorithms to confirm the process~     of medication administration; no human review is necessary.~      The purpose of this study is to evaluate the feasibility and acceptability, and measure the~     accuracy, of the AiCure platform (platform) in patients being treated for opioid dependence~     with Zubsolv® over the course of 12 weeks. The following aims will be tested: 1) to assess~     the feasibility and acceptability to both participants and study staff in using AiCure to~     monitor medication adherence; 2) to evaluate the acceptability of using AiCure to optimize~     care pathways; and 3) to measure the reliability and validity of AiCure in detecting~     interruptions in treatment. To assess feasibility and acceptability of the platform, we will~     measure rates of physician satisfaction and user acceptance. Optimization of care pathways~     will be measured by assessing the sustainability of AiCure use over 12 weeks (retention~     rates) and measuring illicit opioid use (urine drug screens) compared to historical data.~     Reliability and validity of AiCure will be measured by comparing AiCure adherence against~     pharmacokinetic data.~      All participants will be requested to take each of their prescribed doses using the app.~     Participants will be able to download the app onto their own smartphone or will be~     provisioned a device at the start of the study. The data captured during the medication~     ingestion process will be automatically encrypted and stored on the participant smartphone~     and uploaded wirelessly to a cloud-based dashboard. If a participant is non-adherent (missed~     dose, incorrect dosage) or if suspicious behavior is detected, an automated alert will be~     sent to study staff via email or SMS to prompt immediate intervention. In addition, all~     participants will receive treatment as usual.~   "
101125|NCT02243657|"~     The study investigates how safe ASP3652 is and how well it is tolerated when taken as~     multiple doses. The study also assesses how quickly and to what extent it is absorbed and~     eliminated from the body. In addition, the effects of age and gender are investigated.~      The study consists of two parts. In Part 1 four dose levels are administered to four separate~     groups initially. Two additional dosages are then investigated. Subjects receive either a~     once-daily dose (QD) or twice-daily dose (BID) of ASP3652 or placebo.~      Part 2 is performed in one group of elderly healthy male or female (post-menopausal)~     subjects. Subjects receive either a twice daily dose (BID) of ASP3652 or placebo.~      For both parts of the study, the subjects stay in the clinic for one period of 18 days.~   "
101126|NCT02243644|"~     Comparing the effect of two different duration of same drug albendazole in patients with~     Neurocysticercosis less than or equal to 5 lesions on CT head at the end of 6 months.~   "
101127|NCT02243631|"~     This study will investigate the hypothesis that probenecid, a medication currently used for~     gout, reduces levels of ATP in the joint fluid of patients with calcium pyrophosphate~     deposition disease (CPPD), another common type of crystal-related arthritis. There is good~     evidence that CPPD results from an excess of ATP in joints. The investigators will measure~     levels of ATP in joint fluid before and after 5 days of treatment with probenecid. This study~     will serve to rationalize larger studies of probenecid in CPPD.~   "
101128|NCT02243618|"~     Endoscopic submucosal dissection (ESD) is an advanced technique that enables en bloc~     resection of superficial tumors in the gastrointestinal tract. ESD, however, is a~     time-consuming procedure that requires a high level of endoscopic skill to achieve a~     desirable oncologic outcome. Several procedure-related complications may occur after ESD.~     Especially, iatrogenic ulcer bleeding after ESD can be a concern for both endoscopists and~     patients. In order to reduce the bleeding rate, proton pump inhibitors (PPIs) are~     administered after ESD. In addition, ulcer protective agents such as rebamipide can be added~     to PPIs for accelerating ulcer healing. We aimed to evaluate the efficacy of polaprezinc for~     healing of iatrogenic ulcer.~   "
101129|NCT02243605|"~     This phase II trial studies how well cabozantinib-s-malate works in treating patients with~     osteosarcoma or Ewing sarcoma that has grown or returned (come back) after a period of~     improvement. Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth and may also prevent the growth of new blood vessels that~     tumors need to grow.~   "
101130|NCT02243592|"~     This pilot research trial studies molecular profiling in tissue samples from patients with~     cancer who got better with treatment that didn?t work for most other patients with the same~     disease. Studying samples of tissue from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify~     biomarkers related to how well patients respond to treatment.~   "
101131|NCT02243579|"~     This phase II trial studies how well pembrolizumab works in treating patients with stage~     IB-IVB mycosis fungoides or Sezary syndrome that has returned after a period of improvement~     or has not responded to at least one type of treatment. Monoclonal antibodies, such as~     pembrolizumab, may block cancer growth in different ways by targeting certain cells.~   "
101133|NCT02243553|"~     Primary: To quantify the influence of single-dose and steady-state tipranavir/ritonavir~     500/200 mg on intestinal and hepatic cytochrome P450 (CYP) and P-glycoprotein (P-gp)~     biomarkers, as a means of predicting drug interactions. The AUCs for biomarkers caffeine,~     warfarin, omeprazole, dextromethorphan, midazolam, and digoxin will be assessed.~   "
101134|NCT02243540|"~     The aim of this study was to evaluate an impact of preoperative bladder underactivity on~     treatment outcomes of photoselective vaporization of the prostate (PVP) or holmium laser~     enucleation of the prostate (HoLEP) in the treatment of benign prostatic obstruction, and to~     compare it between the two types of surgery for benign prostatic hyperplasia.~   "
101135|NCT02243527|"~     The effects of inspiratory muscle training (IMT) remain controversial. Many studies have~     examined the effect IMT has on exercise performance, but any changes to the body that come~     from IMT have yet to be looked at.~      This study will look at how someone breathes can change after IMT. Understanding how IMT~     changes the body can help us use IMT in different treatments.~   "
101136|NCT02243514|"~     Sympathetic hyperactivity is a causal or a promoting factor in many diseases, under these~     conditions, some morphology changes due to the hyperactivity occur. Renal nerve is an~     important part in the autonomic nervous system regulation, especially in cardiovascular~     system, the modulation of the renal nerves used as a therapeutic strategy has been researched~     across the world. The purpose of this study is to evaluate and quantify the morphology~     changes in different diseases, make the modulation therapy more selective and effective.~   "
101137|NCT02243501|"~     Up to 25% of children suffer from sleep problems categorized as insomnia: difficulty~     settling, falling asleep, and staying asleep. This leads to daytime sleepiness and negatively~     effects behaviour, mood, and academic performance. It also has negative effects on primary~     caregiver's sleep and their daytime functioning. Despite robust evidence supporting the~     efficacy of behavioural treatments for insomnia in children, very few receive these~     treatments. The most common treatment for insomnia in children is medication. This pattern of~     care is troubling because there are no approved medications for insomnia in children, and~     there are concerns about the safety and side effects of these medications. One of the primary~     reasons for the low rate of evidence-based treatment is the shortage of available treatment~     resources for both parents and health care providers.~      When evidence-based treatments are available, they are usually provided in a traditional~     service delivery framework. These traditional approaches are often very difficult for parents~     to access due to scheduling conflicts, incidental costs, and travel difficulties. Thus, there~     is a critical need for access to effective interventions focused on insomnia for children,~     and increased knowledge for parents and health care providers about appropriate treatments~     for insomnia.~      The Better Nights, Better Days (BNBD) program will provide a potential solution to one of the~     most common treatment barriers: access to care. BNBD will provide a readily accessible~     distance treatment via the internet, to increase access to evidence-based care for insomnia~     in typically developing children aged 1 to 10. BNBD was developed based on evidence-based~     programs and extant literature. The investigators will conduct a randomized controlled trial~     (RCT) in which participants (primary caregivers of children ages 1 to 10 years with insomnia)~     will be assigned to Intervention or Usual Care based on a 1-to-1 allocation. The effects of~     this behavioural sleep intervention will be assessed at 4 and 8 months post baseline~     assessment. Assessment will include both sleep and daytime functioning of the children, and~     daytime functioning of their caregivers.~      This study aligns with the recognized need to more rapidly transfer new scientific knowledge~     to improve patient care and population health, and targets the validation of new treatment~     delivery models to increase availability of effective treatment.~   "
101138|NCT02243488|"~     This study builds on the pilot work of the Irise research group to investigate the impact of~     menstrual hygiene interventions on East African girls' school attendance, activities of daily~     living and self-esteem. The trial will be carried out in 40 schools to either intervention or~     control arms. Schools will receive a menstrual hygiene program, including the distribution of~     reusable sanitary pads and menstrual health education. The impact of the programme on girls'~     school attendance will be monitored using the validated Irise questionnaire and school~     registers. The impact of the programme on activities of daily living during menstruation and~     self-esteem during menstruation will also be measured using the Irise Questionnaire and~     explored using focus groups.~   "
101139|NCT02243475|"~     Neuropathic pain is a frequent feature of peripheral neuropathy causing a significant impact~     on patients' quality of life and health care costs. Not all individuals with neuropathy~     develop pain and it is not possible to predict who is more or less susceptible among those~     with similar risk exposure. Current inability to identify high-risk individuals hinders~     development and application of therapies to counteract neuropathic pain and to address~     targeted prevention strategies. Recently, the investigators Consortium has identified novel~     pathogenic mutations in genes encoding for two sodium channels (Nav1.7 and Nav1.8) known to~     play a critical role in the generation and conduction of action potentials in nociceptors and~     their terminal axons. This study was undertaken in a carefully selected group of patients~     with painful neuropathy using a candidate gene approach and directly revealed targets for new~     therapeutic strategies. This discover widened the spectrum of sodium channel-related pain~     disorders including conditions more common in the general population than those known so far.~     PROPANE STUDY, starting from the hypothesis of a common origin of neuropathic pain in a~     cohort of patients with predominantly small fibre neuropathy, aims to develop this original~     idea in a larger and well characterized study population, to provide evidence for the~     reliable stratification of patients at high risk and potential new treatments tailored on~     patients' clinical features, in order to improve their quality of life.~   "
101140|NCT02243462|"~     Shivering is one of the most commonly recognized problem associated with anesthesia, It is~     believed to be thermoregulatory in origin. Studies suggest that pre-warming the patient prior~     to the surgery can reduce the chances of hypothermia induced shivering during the post~     operative period.~      Forced air warmers are the most frequently used active warming devices in the peri-operative~     setting. Currently, our hospital does not pre-warm patients but if our study shows that~     pre-warming reduces post-operative shivering, we will be able to make an evidence based~     decision to start this practice.~   "
101141|NCT02243449|"~     During weaning the work of breathing is transferred from the ventilator back to the patient.~     Approximately 40% of the time on ventilators is spent weaning. Studies support the use of~     screening protocols and tests of patient's ability to breathe spontaneously (SBTs) to~     identify weaning candidates. The investigators work demonstrates that once daily screening is~     the current standard of care. The conduct of daily ward rounds and once daily screening in~     ICUs is poorly aligned with the rapidly changing clinical status of critically ill patients.~     With respiratory therapists (RTs) in Canadian intensive care units (ICUs), a significant~     opportunity exists to screen patients more often, conduct more SBTs, and reduce the time~     spent on ventilators and in the ICU. Only one mechanical ventilation trial has focused on the~     elderly and no trial has evaluated weaning outcomes in the elderly and very elderly which may~     be influenced by the presence of comorbidities, frailty, malnutrition and treatment~     limitations.~      The investigators propose to conduct a pilot randomized trial in 100 elderly (>/= 65 years)~     critically ill adults comparing 'once daily' screening to 'at least twice daily' screening in~     8 adult ICUs. In the proposed trial, the investigators will (i) evaluate their ability to~     recruit elderly (>/= 65 years) critically ill patients into a weaning trial and (ii) assess~     whether protocols can be adhered to similarly between elderly (65 to 80 years) and very~     elderly (>80 years) trial participants. Moreover, they will also address generalizability~     issues in the conduct of mechanical ventilation research by evaluating potential biases~     associated with exclusion criteria and consent between elderly and very elderly patients and~     obtain preliminary estimates of differences in important clinical outcomes between elderly~     and very elderly participants.~   "
101143|NCT02243423|"~     This study aims to compare the neonatal acid-base status of women who remain supine~     horizontal, with women who are tilted to the left side by 15° during elective cesarean~     delivery at term under spinal anesthesia, with systolic BP maintained at baseline with a~     phenylephrine (PE) infusion. The null hypothesis is that the position of the patient (supine~     horizontal or tilted) during cesarean section will make no difference to neonatal wellbeing.~     The primary outcome will be the neonatal umbilical arterial base deficit (BD) at birth. The~     investigators will also examine the effects of maternal position during cesarean section~     under spinal anesthesia on maternal cardiac output (CO) and whether these changes have a~     correlation with the neonatal umbilical cord blood acid-base status. The secondary outcome~     will be the total phenylephrine dose requirement at 15 minutes after spinal injection.~   "
101144|NCT02243410|"~     It has come to our attention that there is not a general consensus of how to apply Visual~     Analogue Scale (VAS) as a tool in measuring pain amongst postoperative patients in Denmark.~      The assumption is that patients will grade the level of pain differently dependent on how VAS~     is presented.~   "
101145|NCT02243397|"~     The purpose of the study is to investigate the different types and subtypes of cells found in~     breast tumors. The investigators will do this using a variety of molecular analysis tools~     that may allow for improved tests. The different types of cells in breast cancer impacts the~     way individuals respond to various treatments.~   "
101146|NCT02243384|"~     The purpose of this research is to compare short-term and long-term efficacy of laparoscopic~     hepatectomy and radiofrequency ablation in the Treatment of early hepatocellular carcinoma,~     and provide the evidence for the choice of surgical method from the pathology and cytology.~   "
101147|NCT02243371|"~     The primary objective of this study is to compare the overall survival (OS) of subjects with~     previously treated metastatic pancreatic cancer treated with cyclophosphamide~     (CY)/nivolumab/GVAX pancreas vaccine followed by nivolumab/CRS-207 (Arm A) to subjects~     treated with CY/GVAX pancreas vaccine followed by CRS-207 (Arm B).~   "
101148|NCT02243358|"~     To evaluate the safety and effectiveness of a novel neoadjuvant treatment strategy~     incorporating 5-fluorouracil/leucovorin with oxaliplatin ( FOLFOX )chemotherapy in~     combination with chemo-radiation with gemcitabine.~   "
101149|NCT02243345|"~     Decompression sickness syndrome (DCS) is caused by microbubbles forming in blood vessels or~     tissues during a reduction in environmental pressure (decompression). Bubbles have~     mechanical, embolic and biochemical effects with manifestations ranging from none to fatal.~     By reducing bubble volume and hastening inert gas elimination, recompression therapy with~     hyperbaric treatment remains the main therapy for DCS. The most common hyperbaric protocol~     used, is based on US Navy Treatment table 6, started as early as possible after surfacing.~     The outcome of hyperbaric therapy varies with reported complete resolution in 13%-63% of the~     patients suffering from severe DCS, and in 73%-100% of the patients with mild-moderate DCS.~      The significance of time to recompression is controversial. It has been suggested that early~     hyperbaric treatment improves the outcome by decreasing bubble size and avoiding further~     tissue injury. However, in recent studies time to recompression had very little effect on~     clinical recovery. Moreover, the time beyond which hyperbaric treatment isn't effective has~     not been determined yet.~      The aim of this study was to evaluate the clinical outcome of delayed hyperbaric treatment to~     divers who referred to tertiary care hospital hyperbaric unit, more than 48 hours after~     surfacing. The clinical outcome of the delayed hyperbaric treatments was compared to early~     treatments given at the same hyperbaric unit.~   "
101150|NCT02243332|"~     The purpose of this small, pilot study is to evaluate a novel device that uses neuromuscular~     electrical stimulation to assist quadriceps muscles as a user walks. This study will involve~     use of this device on individuals with patellofemoral pain, a relatively common injury among~     active people, to see if quadriceps stimulation could mitigate disparities in quadriceps~     activation timing that may indirectly lead to knee pain.~   "
101151|NCT02243319|"~     The purpose of this study is to investigate the pharmacokinetic drug interactions between~     HGP1201 and HGP0904~   "
101152|NCT02243306|"~     GSK1278863 is an orally-active, novel small molecule agent which inhibits hypoxia-inducible~     factor (HIF) prolyl -4- hydroxylases (PHDs) and is in development for the treatment of~     anaemia associated with chronic kidney disease (CKD). As the kidney represents a major site~     of elimination for many drugs and their metabolites, and GSK1278863 will be administered to~     subjects with various stages of renal disease, it is important to characterize the~     pharmacokinetics in this target patient population. The purpose of this study is to~     characterize the pharmacokinetics of GSK1278863 and its metabolites in subjects with end~     stage renal disease (ESRD) undergoing peritoneal dialysis. This will be a repeat-dose,~     open-label, parallel-group study. Approximately 30 subjects with ESRD will be enrolled in two~     cohorts (15 subjects in each cohort) to ensure that 6 subjects on continuous ambulatory~     peritoneal dialysis (CAPD) (cohort 1) and 6 subjects on automated peritoneal dialysis APD~     (cohort 2) complete dosing and critical assessments. GSK1278863 will be administered once~     daily for 14 days. Primary pharmacokinetic assessments will be made on Days 1 and 14.~   "
101153|NCT02243293|"~     The purpose of this phase 2/3, open-label, multipart, multicenter study was to evaluate the~     efficacy, and safety of co-administration of ABT-493 and ABT-530 with and without ribavirin~     (RBV) in chronic HCV genotype 2 (GT2-), genotype 3 (GT3-), genotype 4 (GT4), genotype 5~     (GT5-), or genotype 6 (GT6-) infected participants with or without cirrhosis.~   "
101154|NCT02243280|"~     The purpose of this Phase 2, open-label, 2-part, multicenter study was to evaluate the~     efficacy, safety, and pharmacokinetics of co-administration of ABT-493 and ABT-530 with and~     without ribavirin (RBV) at different doses in chronic Hepatitis C virus (HCV) Genotype 1~     (GT1), Genotype 4 (GT4), Genotype 5 (GT5), and Genotype 6 (GT6) infection with compensated~     cirrhosis (GT1 only) or without cirrhosis (GT1, GT4, GT5, or GT6). Although RBV was initially~     planned in the protocol, it was not administered in any of the study arms.~   "
101229|NCT02242305|"~     In contrast with Hyoscine Butylbromide Capsule 10mg, Study is to evaluate the efficacy and~     safety of Hyoscine Butylbromide tablets 10 mg (20mg, 3 times daily, orally) over a period of~     3 days for the treatment of occasional or recurrent episodes of self-reported gastric or~     intestinal spasm-like pain or discomfort~   "
106303|NCT02175953|"~     This study is to test the feasibility (pilot part) and efficacy (phase IIa part) of a~     specifically on the needs of caregivers of people with dementia composed new short-term~     psychotherapeutical intervention.~   "
101155|NCT02243267|"~     The investigators are creating a data and specimen repository to study causes , early~     detection, prevention and treatment of colon and rectal cancer. The investigators are~     collecting data and specimens (blood, stool, urine and tissue) from people who have colon or~     rectal cancer, or who are risk for developing colorectal cancer or had normal colonoscopies.~     Data and samples are held in the repository until there are enough to be used for a large~     study or until there are new techniques that can be used to test them. The GI SPORE Program~     at the University of Michigan maintains a repository of specimens for colorectal diseases~     that the investigators hope will help fuel new research. The investigators hope that this~     work may lead to new treatments or earlier detection of colorectal cancer or improved~     diagnosis and treatment of other colon and rectal diseases.~   "
101156|NCT02243254|"~     Postoperative hyperalgesia has been reported after intraoperative administration of small or~     high-dose remifentanil. Cyclooxygenase inhibitor exhibit preventive effects on the~     development of opioid-induced hyperalgesia. The aim of this study is to evaluate the~     preventive effect of intravenous ibuprofen (Caldolor®) on remifentanil-induced hyperalgesia~   "
101157|NCT02243241|"~     Evaluate the effect of multiple doses (once daily for 3 days each of HYD 80, 120, and 160 mg~     tablets) on the QT/QTc interval.~   "
101158|NCT02243228|"~     The purpose of the study is to evaluate if inhaled granulocyte-macrophage colony stimulating~     factor delay the increase in alveolar-arterial oxygen difference, compared to no treatment,~     for adult patients with mild-to-moderate autoimmune pulmonary alveolar proteinosis in China~     over a two-year period.~   "
101159|NCT02243215|"~     The study is a randomized study exploring the difference between off-site vs. on-site~     training in laparoscopic skills. The study will be performed using fifty surgical trainees~     from the departments of urology, surgery and gynecology. The participants will be recruited,~     enrolled and randomized during the introductory course in basic laparoscopic techniques held~     six times annually at Center of Clinical Education(CEKU).~      Participants will be able to train laparoscopic skills on a Box Trainer(BT) and on a Virtual~     Reality Simulator(VRS). They will practice until they reach a predefined level of proficiency~     on seven basic modules, the procedure module; salpingectomy on the LapSim™ and reach the~     passing level of 358pts on the Training and Assessment of Basic Laparoscopic~     Techniques(TABLT) technical test.~      The intervention group will have a portable trainer available to allow training at their~     convenience, be it at home or at work. The control group will only practice on-site at CEKU~     and at their local hospital.~      Participants will be asked to keep a training log with details of time spend on training and~     number of training sessions. The training log will contain information on any type practice~     involving laparoscopy be it on a BT or a VRS at the local hospital, at home on the tablet~     trainer or training at CEKU. Also time spend in the operation room, assisting or performing~     laparoscopic surgery will be registered.~      To pass the TABLT all participants will book a test session at CEKU for their final test at~     the end of their training. At the test sessions TABLT test scores will be established on site~     by the Chief Investigator and afterwards using video recordings of the test. A blinded rater~     will give scores based on the video recordings and this will be the decisive rating to~     determine whether the participant has passed the test.~      To pass the VRS training an employee at CEKU will monitor a VRS practice session in which~     proficiency level is reached.~      The enrollment of participants is expected to finish June 2015 a data analysis will be~     performed in July 2015.~   "
101160|NCT02243202|"~     The purpose of this study is to compare the effects of canagliflozin and phentermine to those~     of placebo to promote on a change in body weight over a 26 week period.~   "
101161|NCT02243189|"~     The purpose of this study is to investigate the cytokine levels in nasal lavage and gene~     expression in nasal scraping following a single nasal dose of JNJ-43260295 in healthy~     participants, and in atopic mild to mild-persistent asthmatic (breathing disorder in which~     there is wheezing and difficulty in breathing) participants with and without nasal allergen~     challenge prior to dosing.~   "
101162|NCT02243176|"~     SMART Study - A 24-Week, Multicenter, Randomized, Parallel-group, Open-label, Active~     Controlled Phase IV Study to Assess the Efficacy, Safety and Tolerability of Saxagliptin~     Compared with Acarbose when in Combination with Metformin in Patients with Type 2 Diabetes~     Mellitus (T2D) Inadequately Controlled with Metformin Monotherapy~   "
101163|NCT02243163|"~     The purpose of study is to investigate if yoga exercise improve life quality and immune~     status in breast cancer patients after complete treatment (including surgery and / or~     radiotherapy and / or chemotherapy)~   "
101164|NCT02243150|"~     This first-in-human (FIH) study will provide the first safety, PK, and PD data of G1T28-1 in~     humans and will allow further development of G1T28 1 in patients with cancer to reduce~     chemotherapy-induced myelosuppression.~   "
101165|NCT02243137|"~     This is a phase I clinical trial in healthy volunteers comparing the effect of lysine~     acetylsalicylate or aspirin on platelet function.~   "
101166|NCT02243124|"~     The purpose of the study is to test the safety of six cycles of cenersen treatment and to~     begin to test the hypothesis that intermittent administration of cenersen may lead to a~     reduced dependence on transfusion.~   "
101167|NCT02243111|"~     Doppler signals can be recorded from the lung parenchyma by means of a pulsed Doppler~     ultrasound system incorporating a special signal processing package; i.e. the transthoracic~     parametric Doppler (TPD) (EchoSense Ltd., Haifa, Israel). Systemic sclerosis patients often~     develop pulmonary vascular disease leading to pulmonary hypertension. The TPD system may~     provide important insight into pulmonary blood vessels characteristics by the LDS signals~     that are related to pulmonary hypertension.~      The TPD performance in detecting PAH in SSc patients will be assessed in the study.~   "
101168|NCT02243098|"~     The trial is conducted in Europe. The aim of the trial is to investigate the influence of~     semaglutide on the pharmacokinetics (the exposure of the trial drug in the body) of single~     doses of atorvastatin and digoxin in healthy subjects.~   "
101169|NCT02243085|"~     The aim of this study was to investigate the incidence of de novo urge urinary incontinence~     after the photoselective vaporization of the prostate for benign prostatic hyperplasia using~     the validated overactive bladder symptom score, and to determine the predictors of de novo~     urge urinary incontinence following the photoselective vaporization of the prostate.~   "
101170|NCT02243072|"~     Adolescents with T1D and chronic poor metabolic control are at high risk for short and~     long-term diabetes complications and are heavy users of both medical resources and health~     care dollars. The purpose of the proposed study is to collaborate with a community agency to~     develop and test an intervention, Fit Families, that uses the core components of a previously~     successful home-based family treatment, but that can delivered by lower cost community health~     workers. If successful, Fit Families could improve health outcomes in a vulnerable population~     at high risk for diabetes complications, and could be translated to real-world treatment~     settings.~   "
101230|NCT02242292|"~     Study to determine whether hyoscine butylbromide can provide adequate symptomatic relief of a~     single episode - defined as lasting not longer than 1 day - and multiple episodes of~     abdominal pain or discomfort associated with cramping when used as needed~   "
101171|NCT02243059|"~     Advanced epithelial ovarian cancer has high morbidity and mortality. Patients presenting with~     advanced stage ovarian cancer often have cancer spread to regional lymph nodes. Imaging~     strategies to depict involved lymph nodes are currently not successful. The purpose of this~     study is to evaluate if magnetic resonance imaging (MRI) with gadofosveset trisodium contrast~     enhancement (GDF-MRI) and diffusion weighted imaging (DW-MRI) is able to identify involved~     lymph nodes in a preoperative setting. This could guide the surgeon during surgery to dissect~     lymph nodes which could lead to an optimal diagnosis/staging with the lowest possible~     morbidity. We want to determine the optimal imaging settings and feasibility of MRI for the~     detection of pathological lymph nodes in women with advanced (FIGO stage IIB-IV) ovarian~     cancer undergoing primary debulking surgery and compare this to conventional imaging with~     computer tomography (CT).~   "
101172|NCT02243046|"~     This is a six (6) month, double-blind, parallel, controlled clinical trial utilizing one~     hundred and sixty (160) adults to evaluate the reduction of dental plaque and gingivitis.~   "
101173|NCT02243033|"~     Target recruitment: 1000 subjects. The purpose of this research study is to continue to~     investigate the safety and effectiveness of using MR (magnetic resonance) guided laser focal~     therapy for prostate cancer and to evaluate oncologic control over 20 years. We hypothesize~     that laser focal therapy can be used to achieve oncologic control in carefully selected~     patients.~      MR uses large magnets to produce pictures of areas/organs inside the body. The laser uses~     light to heat a target area to try to destroy cancerous cells.~      The laser system that will be used is called the Visualase® Thermal Therapy System. This~     system has been used for the treatment of brain, bone (spine), thyroid, and liver cancers.~     However; this study is the first time this system has been studied for use in the treatment~     of prostate cancer with a trans-rectal approach.~      MR-guided biopsies and laser applicator placement will be performed using the Invivo DynaTRIM~     trans-rectal biopsy guidance system. This system is cleared (approved) by the U.S. Food and~     Drug Administration (FDA) for such uses.~   "
101174|NCT02243020|"~     The primary study objectives are to assess the safety and feasibility of the therapy,~     including the surgical intervention and stimulation, as well as to provide information on the~     appropriateness of the study test measures (assessments) and to provide a basis for sample~     size calculations for a larger, pivotal study.~   "
101175|NCT02243007|"~     This research study is a Phase II clinical trial, which evaluates a combination of drugs,~     FOLFIRINOX and Gemcitabine/Nab-Paclitaxel, in the management of participants with resectable~     pancreatic cancer prior to surgery.~   "
101176|NCT02242994|"~     The purpose of this study is to evaluate a touch screen application designed to help~     pediatric patients with cerebral palsy communicate. The study will test how well patients~     type on two different tools: one tool is already on the market , and the second tool is a~     newly developed App.~   "
101177|NCT02242981|"~     This type of study is called a radiolabeled study. For this study, LY2623091 (study drug) has~     been specially prepared to contain radiolabeled carbon [^14C]. [^14C] is a naturally~     occurring radioactive form of the element, carbon. This study will increase understanding~     about how the drug appears in the blood, urine, and stool after it is administered to healthy~     participants. Information about any side effects that may occur will also be collected. This~     study will last up to 22 days for each participant, not including screening. Screening is~     required within 28 days prior to enrollment~   "
101178|NCT02242968|"~     Background:~      - Vaccines and antiviral therapies help prevent and treat diseases. Researchers need a group~     of healthy volunteers for clinical trials. Clinical trials are studies that test these~     vaccines and therapies in people.~      Objective:~      - To screen volunteers for clinical trials for investigational or licensed vaccines or drugs~     to treat or prevent virus infections.~      Eligibility:~      - Healthy adults age 18 65.~      Design:~        -  Participants will be asked questions about their health history, including sexual~          activity and drug use. They will give blood samples. They may have a physical exam. They~          may give a urine sample.~        -  Participants may have the inside of their nose either swabbed or washed with some fluid.~          The fluid will be collected. They may give a stool sample.~        -  Participants may have an electrocardiogram. Soft, sticky patches will be attached to~          participants chest, arms, and legs. They will lie still on a table while the patches~          detect the heart s electrical signals. A machine will record these signals.~        -  Participants may have lung function tests. These tests measure the volume of air moving~          in and out of the lungs. Participants will forcibly blow air into a machine.~        -  Participants will be told if any tests show a medical problem.~        -  If a participant is eligible and decides to join an investigational clinical trial,~          researchers will explain the study and the risks involved. Participants will sign a~          separate consent for that clinical trial.~   "
101179|NCT02242955|"~     Alcohol-dependence is a medical condition that can lead to the occurrence of an alcohol~     withdrawal syndrome (AWS) in case of alcohol drinking cessation. Diazepam is the reference~     medication for preventing or treating AWS. The recommended average diazepam treatment~     duration is usually around one week, and this duration is generally not considered to impact~     the subsequent relapse rate in alcohol drinking.~      However, several previous studies have found that patients experienced frequent anxious~     symptoms during the weeks following detoxification. Such symptoms may foster early relapse in~     alcohol drinking. Furthermore, it has been suggested that this anxiety could pertain to late~     withdrawal symptoms.~      The DIAMA study hypothesizes that extending the diazepam detoxification treatment to one~     month can significantly reduce the cumulated relapse rate in alcohol drinking over the three~     following months.~   "
101180|NCT02242942|"~     This open-label, multicenter, randomized Phase III study is designed to compare the efficacy~     and safety of a combined regimen of obinutuzumab and venetoclax versus obinutuzumab +~     chlorambucil in participants with chronic lymphocytic leukemia (CLL) and coexisting medical~     conditions. The anticipated time on study treatment will be approximately one year and the~     follow-up period will be up to 5 years.~   "
101231|NCT02242279|"~     Study to investigate the dose-dependent bronchodilator effect and the safety of single~     inhalation doses of BEA 2180 inhaled via Respimat® compared to placebo in patients with~     stable Chronic Obstructive Pulmonary Disease (COPD)~   "
103387|NCT02214121|"~     The purpose of this Phase II dose-ranging study is to investigate pharmacokinetic (PK) and~     pharmacodynamic (PD) properties of various doses of ticagrelor followed by 4 weeks of~     twice-daily treatment in paediatric patients with sickle cell disease~   "
101181|NCT02242929|"~     Basal cell carcinoma (BCC) is a slow-growing, locally invasive malignant epidermal skin~     tumour. It is the most common malignant disease in Caucasians, representing approximately 80%~     of all cases of skin cancer and is therefore an important health problem. In the Netherlands~     incidence rates are 165 for men and 157 for women per 100.000 person-years, and these rates~     are rising with 3-10% every year.~      A simplified histological classification of BCCs includes the following three subtypes:~     nodular, superficial and infiltrative variants, with the nodular variant being the most~     frequent type. Although a characteristic feature of BCCs is their low risk to metastasize, if~     untreated they may be locally invasive and may induce considerable functional and cosmetic~     morbidity.~      The gold standard treatment of all histological BCC subtypes is surgical excision (SE), but~     not all patients are eligible for surgery. In patients with multiple BCCs and older patients,~     surgery may lead to significant morbidity, and in some cases, it may result in disfiguring~     scarring. For these reasons and to reduce workload and costs in the healthcare system, there~     is a growing demand for alternative, non-invasive, treatments. An advantage of non-invasive~     treatment options is that they can be performed by other healthcare professionals, such as~     general practitioners and specialized nurses. For treatment of superficial BCCs (sBCC)~     non-invasive treatments, such as topical imiquimod (IMQ), 5-fluorouracil (5-FU) or~     photodynamic therapy (PDT) are already commonly used. Our group investigated the efficacy of~     those three therapies and found that after 3 years, BCCs treated with IMQ had a significant~     lower risk of recurrence, compared to the other therapies.~      A recent study suggests that IMQ, besides being an immune-response modifier, also directly~     inhibits sonic hedgehog (SHH) signalling, the most important pathway active in BCCs. This~     targeted effect of IMQ very likely explains the superior therapeutic effect. Treatment of~     nodular BCC (nBCC) with IMQ has been investigated. Without prior curettage, high efficacy~     rates were found, although efficacy was still slightly inferior to SE.~      The investigators hypothesize that the effectiveness of IMQ following prior curettage will~     not be inferior to SE and that the benefits will be a higher patient satisfaction and lower~     healthcare costs. A recently published discreet choice experiment showed that patients~     preferred IMQ to surgery regardless of previous experience of BCC symptoms and treatment.~   "
101182|NCT02242916|"~     Given that the cost of proton therapy is considerably higher than that of conventional~     radiotherapy with photons, it is necessary to establish whether these higher costs are~     worthwhile in light of the expected advantages2,3,4. Thus, clear evidence of the situations~     in which proton therapy outperforms conventional photon treatment is needed. The~     investigators therefore aim to demonstrate through an in silico trial that proton therapy~     decrease the amount of irradiated normal tissue and, consequently, the risk of side effects~     in the surrounding normal tissue as well as the risk of secondary tumors. The same overall~     treatment time and an equal number of fractions will be used for both treatment modalities~     wherever possible. The most optimal technique for each individual patient, based on objective~     criteria related to limiting dose to normal tissue, will be prescribed by the institution~     concerned for each treatment option.~   "
101183|NCT02242903|"~     The main purpose of this study is to evaluate the safety and how well the body will handle a~     single dose of study drug, LY3079514. This study will last about 12 weeks for each~     participant.~   "
101184|NCT02242890|"~     This study has two goals: 1) to test an approach to helping women who use intrauterine~     contraception (IUC) spread the word about this type of long-lasting, highly effective birth~     control method among their friends and family and; 2) to test ways of getting in touch with~     these women's friends and family so that investigators can track whether this approach is~     effective at spreading birth control information through social groups.~   "
101185|NCT02242877|"~     The aim of this study is to compare the effect of treatment with telmisartan on patients in~     whom the systolic BP is approximately 12 weeks after starting treatment under control for the~     first time between patients with isolated systolic hypertension (ISH) at the beginning to~     patients with systolic/diastolic hypertension (SDH)~   "
101186|NCT02242864|"~     The primary objective was to evaluate the effect of the treatment with Micardis® or~     MicardisPlus® on blood pressure. Secondary objectives were the effect of Micardis® /~     MicardisPlus® on metabolic parameters (triglycerides, cholesterol, LDL blood glucose, insulin~     Homeostasis Model Assessment (HOMA)-index and HbA1c) in patients with essential hypertension~     and diabetes mellitus~   "
101187|NCT02242851|"~     Primary objective: to characterize hypertensive patients treated for at least 1 month with~     Telmisartan (alone or in combination with other drugs) in order to define the beneficiary~     population (those actually receiving the treatment).~      Secondary objectives:~        -  to describe the patients' blood pressure values (when self-monitored) and satisfaction~          with the treatment (ease of use, efficacy, safety) on the basis of a patient~          self-questionnaire, filled out 4 weeks after consultation.~        -  to compare the characteristics of the beneficiary population to those of the initial~          target population defined in the SPC (summary of product characteristics) for~          Telmisartan~   "
101188|NCT02242838|"~     The primary objective of this survey is to prospectively investigate safety and efficacy in~     patients with hypertension treated with telmisartan in proper use in medical practice over a~     long period~   "
101189|NCT02242825|"~     The primary objective is to evaluate the effect of the treatment with Micardis® or~     MicardisPlus® on blood pressure. Secondary objectives are the effect of Micardis® /~     MicardisPlus® on metabolic parameters (triglycerides, cholesterol, blood glucose and HbA1c)~     in patients with essential hypertension and diabetes mellitus~   "
101190|NCT02242812|"~     The primary objective was to show that telmisartan is not inferior to metoprolol succinate in~     respect of the percentage change from baseline in LVMI(H) after a 6.5 months treatment~     period. As secondary objectives, the improvement in left ventricular systolic and diastolic~     function and blood pressure reduction were assessed~   "
101191|NCT02242799|"~     Malaria and HIV are found in the same regions of the world and developing countries are most~     affected by both diseases. For malaria, new drugs have been introduced called ACTs. These~     drugs are effective against malaria but little is known about how the levels of these drugs~     in blood relate to how effective these drugs are. For HIV, a new drug has been developed~     called dolutegravir which has potential to be widely used in developing countries. This~     proposal will explore how dolutegravir affects the drug levels of these antimalarial drugs~     and vice versa. In total, 46 healthy volunteers will participate in this study.~   "
101233|NCT02242253|"~     Main Study: To evaluate and to compare the lung function response to the free combinations of~     tiotropium 18 μg (QD) + salmeterol 50 μg (QD or BID), salmeterol 50 μg BID and tiotropium 18~     μg QD at the end of 6-week treatment periods in patients with COPD.~      Sub-Study: Was performed in subset of patients participating in the Main Study to assess the~     effect of the four randomised treatments on dynamic hyperinflation.~      Extension Study: To establish whether the FEV1 time profile following combination~     bronchodilator therapy of tiotropium plus salmeterol is affected by the pharmaceutical~     formulation of salmeterol, i.e. the MDI or the Diskus®.~   "
101192|NCT02242786|"~     Recently, diffusion-weighted (DW) MR imaging has widened its application on various oncologic~     applications. Especially, it is expected the DW MRI could provide valuable information about~     early response evaluation after treatment using rapid apparent diffusion coefficient (ADC)~     value change. It has demonstrated potential usefulness in response evaluation in the liver~     tumors after treatments such as transarterial chemoembolization (TACE) and radiation therapy~     (RT). Furthermore, it is a functional imaging technique that does not require a contrast~     agent, it can be safely used in patients with renal insufficiency or other medical~     contraindications for contrast agents.~      The optimal assessment of early response of RT could provide one of the most important~     information to prescribe patient and cancer specific RT dose. It might be also important in~     palliative RT of HCC bone metastasis which is related with painful aggressive mass formation.~      This study is performed to evaluate the usefulness of DW MRI in early response evaluation~     after RT for HCC bone metastasis.~   "
101193|NCT02242773|"~     1. Multiparametric MRI ultrasound (MRIus)-guided or direct MRI-guided biopsies will allow~          for more directed sampling of the tumors from compartments with distinct~          multiparametric-MRI (MP-MRI) characteristics, termed habitats, that will increase the~          rate of progression on early (first and second) surveillance biopsies and decrease the~          rate of progression on late (third and further) surveillance biopsies compared to~          historic transrectal ultrasound (TRUS)-guided biopsy rates.~        2. Identifying higher risk tumor early on will reduce the proportions of patients with poor~          response to delayed primary treatment.~        3. Radiomics signatures from MP-MRI will define patterns that are associated with~          progression.~        4. Genomic signatures based on RNA from tumor tissue will define patterns that are~          associated with habitats and radiomics signatures, as well as progression.~   "
101194|NCT02242760|"~     This is a randomized, multi-center, double-blinded study in subjects with moderate to severe~     acne vulgaris. Subjects eligible to enroll will be treated once or twice daily with 2~     concentrations of a topical drug in development or a vehicle. Subjects will be treated for up~     to 12 weeks.~   "
101195|NCT02242747|"~     Background: 5% 5-fluorouracil cream (5-FU) is a well-established treatment for actinic~     keratosis (AK) and ingenol mebutate gel (IMB) is a new topical field therapy.~      Objective: To compare tolerability and safety of IMB with 5-FU for the treatment of facial~     AKs.~      Methods: Open-label, prospective, randomized, controlled clinical trial with 100 patients~     with AKs within 25-cm2 contiguous field on the face. IMB was applied daily for three~     consecutive days. 5-FU was applied twice a day for four weeks. Treatment effect was evaluated~     at baseline and on days 2, 3, 4, 8, 15, 22, 29, 36 and 43, considering ITT populations.~   "
101196|NCT02242734|"~     Determine the influence of hepatic impairment on the pharmacokinetics and metabolism of~     Hydrocodone Bitartrate Extended-Release (HC-ER) 20 mg capsules~   "
101197|NCT02242721|"~     Approximately 300 patients have to be enrolled in the study. They are followed up until the~     end of ICU stay. Usually in clinical routine, patients suspected to have infection and~     simultaneously renal dysfunction making CVVHDF necessary. After enrolment blood and dialysate~     specimens are drawn and sent for analysis on specific time points. The analysis results are~     sent back to the study team at the Charité - Universitätsmedizin Berlin and enable them to~     optimize antiinfectiva treatment of the study patients.~      Data are used to test calculation tools and modify them if necessary.~   "
101198|NCT02242708|"~     The purpose of this study is to evaluate the efficacy of shift nurses practicing alternative~     nostril breathing to improve life quality, autonomic nervous system and immune status.~   "
101199|NCT02242695|"~     A clinical study to compare the clinical efficacy of vaginal tablets containing 10mg~     dequalinium chloride (Fluomizin) with the clinical efficacy of 100mg clotrimazole in patients~     suffering from vulvovaginal candidiasis, to assess safety of the two medications during the~     treatment, and to evaluate women's satisfaction with the two treatments.~   "
101200|NCT02242682|"~     The purpose of this study is to determine if video education is an effective means of~     caregiver education in the waiting room of a pediatric emergency department (ED). This will~     be tested with the showing of a child passenger safety video.~   "
101201|NCT02242669|"~     The purpose of this study to evaluate peer-led mutual help organizations (MHOs) that target~     individuals with psychiatric diagnoses such as mood disorders, and provide evidence either~     supporting the expansion of such groups and the development and testing of clinical~     procedures, or point toward reevaluation and development of alternative low-cost, community~     based approaches to promoting recovery among individuals suffering from these disorders.~   "
101202|NCT02242656|"~     MP-101 will be evaluated in this study to see if it is safe, tolerable, and can help people~     with Short Bowel Syndrome. This study will also find out if taking MP-101 can improve the~     symptoms of Short Bowel Syndrome and reduce the number of times subjects experience bowel~     movements.~   "
101203|NCT02242643|"~     The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals'~     quadrivalent influenza vaccine (GSK2282512A) compared to Sanofi Pasteur's Fluzone®~     Quadrivalent in children 6 to 35 months of age.~   "
101204|NCT02242630|"~     It is currently unknown whether or not the improvement in pain and function related to a~     steroid shot for shoulder pain due to subacromial bursitis is important. This study seeks~     to determine whether 20 mg or 40 mg of either triamcinolone or methylprednisolone~     significantly affect improvement in shoulder pain 6 weeks after injection.~   "
101232|NCT02242266|"~     The primary objective of this trial was to establish non-inferiority of lung function~     response to tiotropium 10 μg, formulated as inhalation powder in the polyethylene hard~     capsule and delivered via the HandiHaler® 2, compared to tiotropium 18 μg, formulated as~     inhalation powder in the hard gelatine capsule and delivered via the HandiHaler® (Spiriva®)~     following single dose inhalation in patients with COPD. A hard polyethylene (PE) capsule with~     half the strength (tiotropium 5 μg) was included to investigate a dose ordering effect.~      The secondary objectives were to characterize the pharmacokinetics of tiotropium inhalation~     powder hard PE capsule (delivered via HandiHaler® 2) and tiotropium inhalation powder hard~     gelatine capsule (delivered via HandiHaler®) and to compare the safety of the two~     pharmaceutical formulations.~   "
101234|NCT02242240|"~     Study to establish the lung function effects of added formoterol (12μg QD and BID) during~     2-week periods to pharmacodynamic steady state of tiotropium(18μg QD)~   "
101205|NCT02242617|"~     Obstructive sleep apnea (OSA) is a major health problem affecting over 1,000,000 Canadians.~     It is the cause of significant healthcare costs with increased morbidity and mortality. The~     two most common and effective therapies used to treat OSA are: (1) Continuous or Automatic~     Positive Airway Pressure (PAP), and (2) Mandibular Advancement Splints (MAS). While both~     therapies reduce upper airway collapse during sleep, they differ in efficacy, acceptance,~     cost and side-effects, but surprisingly are similar in improving quality of life, sleepiness~     and blood pressure. PAP is more effective in reducing apneas while MAS is easier to use.~     Until now, studies have used self-reported adherence data on MAS versus objective adherence~     on PAP. Many studies have hypothesized that the sub-optimal efficacy with MAS therapy is~     counterbalanced by the superior adherence relative to PAP, resulting in a similar~     effectiveness for both treatments. Compliance smart chips are a recent innovation for MAS and~     could be used to prove this hypothesis and allow a new and complete comparison of~     effectiveness (efficacy + adherence) between MAS and PAP. Understanding the patient's~     objective adherence and long-term symptomatic improvement would provide vital information to~     doctors and dentists in choosing the right treatment for patients. Sixty OSA patients will~     receive both PAP and MAS in a random sequence. This innovative study lead by two experienced~     new investigators, and a research team of multidisciplinary experts, will assess objective~     adherence, treatment efficacy, patient preference, sleepiness and quality of life of each~     treatment used at home for 1 month per treatment. After this, patients will be able to go~     back and forth between both treatments during an additional 6-month period. The results of~     this study will be used by healthcare policy makers as well as clinicians who need to be part~     of the treatment plan decision for the many Canadians who suffer from sleep apnea.~   "
101206|NCT02242604|"~     Our purpose is to investigate the improvement of the cognitive, neuropsychologic and physical~     capabilities using a standardized multidimensional geriatric assessment (MGA) consisting of a~     battery of validated assays after correction of hyponatremia in patients 70 years or older.~   "
101207|NCT02242591|"~     The purpose of this study is to evaluate the effect of adductor canal block (ACB) vs. placebo~     on muscle strength, mobility and pain on the first postoperative day after total knee~     alloplastic (TKA).~   "
101208|NCT02242578|"~     Symptomatic treatment of the negative symptoms in schizophrenia (such as social withdrawal,~     affective flattening, poor motivation, and apathy) with medications and psychotherapy are~     almost non-existent, whereas treatment of the positive symptoms (hallucinations and~     delusions) has been more effective with psychotropic medications. The proposed research on~     human subjects using a non-invasive technology (such as repetitive transcranial magnetic~     stimulation [rTMS]) will provide efficacy data for treating negative symptoms.~      The hypotheses are that 1) Cerebellar stimulation will cause activation of thalamic and~     frontal cortical networks associated with attentional processes as a component of the~     distracted affect of schizophrenia; 2) Cerebellar stimulation will cause activation of the~     reticular activating system (RAS), and this will allow the mutism, which is a negative~     symptom, to be partially improved.~   "
101209|NCT02242565|"~     The purpose of this study was to assess the safety, effectiveness and acceptability of~     providing a reduced number of ShangRing sizes for adult voluntary medical male circumcision~     (VMMC) within routine service delivery in Lusaka, Zambia.~   "
101210|NCT02242552|"~     A new research paradigm that involves sequencing tumor DNA/RNA to identify driver mutations,~     select among the Health Canada approved drugs (for adult cancers) known to block certain~     oncogenic pathways, and recommend these drugs to the treating physician, without taking into~     account the tumor histology.~      In this paradigm, the treatment is targeted to the actionable mutation(s) i.e. those driving~     oncogenesis. It is also personalized to the molecular signature of the patient's tumor,~     irrespective of its histopathological subtype. The experience of the investigators team in~     genomics, including next generation sequencing and bioinformatic analysis combined with the~     clinical expertise, bring at last this approach within our technical capacities. In parallel,~     the number of Health Canada-approved drugs (which have been tested in a pediatric setting)~     designed to interfere with oncogenesis pathways is increasing exponentially.~   "
101211|NCT02242539|"~     In this study, we aim to improve child nutrition by increasing parents' awareness of their~     children's physical growth. We use a cluster-randomized trial design to evaluate two~     interventions that provide parents with regular information on their children's physical~     development and growth: 1) distribution of full-sized growth charts for measurement of child~     height within households; and 2) organization of community-based meetings, during which~     children's height and weight are measured by trained project staff.~   "
101212|NCT02242526|"~     The investigators propose a randomized, single blinded controlled trial to compare the use of~     synthetic versus biologic mesh in hiatal hernia repair, two currently accepted standard of~     care surgical modalities. The investigators hypothesize that use of synthetic mesh will have~     lower recurrence at these time points compared to use of biologic mesh.~   "
101213|NCT02242513|"~     Although there are many conservative method for plantar fasciitis, patients might spend 2~     years to achieve resolution. Recent study have shown that pulsed radiofrequency (PRF)~     lesioning of peripheral nerve can alleviate kinds of pain condition. However there are no~     studies of PRF lesioning of the tibial nerve in patients with plantar fascilitis by using~     ultrasound-guided (UG) techniques.~   "
101214|NCT02242500|"~     The purpose of this study is to compare the clinical outcomes after coronally advanced flap~     technique (CAF) associated or not to a porcine collagen matrix graft (CM) in the treatment of~     single gingival recessions. For this blinded randomized controlled clinical trial, 40~     patients with Miller Class I or II gingival recession ≥ 2 mm in canines or premolars will~     selected and randomly assigned to receive either CAF or CAF+CM. The clinical parameters~     evaluated will be probing depth, clinical attachment level, gingival recession height, height~     and thickness of keratinized tissue. Clinical measurements will be taken at baseline and 45~     days, 2, 3 and 6 months after surgery.~   "
101215|NCT02242487|"~     This study is a 12-month, dose-level blinded, multicenter study of 2 inhaled dose levels of~     CVT-301 for the treatment of up to 5 OFF episodes per day in PD patients experiencing motor~     fluctuations (OFF episodes). All patients will receive active treatment, but patients will be~     blinded to dose level. This will serve as an extension to the CVT-301-004 study for those~     patients who participated in that study and remain eligible for this study. In addition,~     patients who previously completed the CVT-301-003, CVT-301-009 and CVT-301-005 (observational~     arm completers), as well as CVT-301 naïve patients may be enrolled if they meet the~     CVT-301-004E eligibility criteria.~   "
101244|NCT02242110|"~     Exposure, relaxation, and rescripting therapy (ERRT) is a promising psychological~     intervention developed to target trauma-related nightmares and sleep disturbances. Though~     further evidence is needed, ERRT has shown strong support in reducing the number and~     intensity of nightmares, as well as improving overall sleep quality in both civilian and~     veteran samples. This study will assess the efficacy in individuals diagnosed with bipolar~     disorder.~   "
101216|NCT02242474|"~     Rheumatoid arthritis (RA) is a frequent inflammatory arthritis that can lead to severe joint~     deformity and often requires orthopaedic surgical interventions. Anti-Tumor Necrosis Factor α~     (anti-TNFα) are biological disease-modifying antirheumatic drugs (DMARDs) increasingly used~     in the treatment of rheumatoid arthritis. An increased risk of opportunistic infection was~     demonstrated in patients treated with those drugs. This observation led many national~     committees to recommend anti-TNFα suspension in the perioperative period to avoid a raise in~     the postoperative infection risk in those patients. This approach is not supported by the~     data available in the current literature and it exposes patients to an increased risk of~     inflammatory flare ups of their disease during and after anti-TNFα suspension, which can~     compromise their postoperative rehabilitation and their quality of life.~      The objective of this prospective randomized multicentric trial is to determine the effect of~     anti-TNFα suspension in the perioperative period on the postoperative infection risk.~     Overall, 660 rheumatoid arthritis patients requiring an elective foot or ankle surgery will~     be randomized into two groups. In the first group, anti-TNFα will be stopped 3 half-lives~     before the surgery while they will be continued in the second group. The postoperative~     infection rate will be compared between the two groups. Postoperative complication rates,~     flares and revision surgeries as well as the functional improvement will be compared.~      The study hypothesis is that there is no significant difference in the risk of postoperative~     infection between the two groups.~      Results from this study will help determine the optimal way to use anti-TNFα in the~     perioperative period and will therefore improve the quality of life of rheumatoid arthritis~     patients.~   "
101217|NCT02242461|"~     We hypothesize that add-on Rhodiola L extract capsule to the regimen of patients with~     moderate-to-severe COPD (1) may provide a potential of systemic effects of anti-inflammation~     and anti-oxidation for these patients, and these effects (2) may reflect in the improvement~     of patients' physiological measurements, quality of life and exercise tolerance.~   "
101218|NCT02242448|"~     Background:~      - Computed tomography (CT) scanning is a procedure that helps doctors with diagnoses. It uses~     X-ray radiation to produce an image in three dimensions. Researchers want to study how to get~     the best quality CT scans using the lowest possible radiation dose.~      Objective:~      - To determine how to improve CT scanning.~      Eligibility:~      - Adults 45 years of age and older who have not had a CT scan in the past year and do not~     have kidney disease.~      Design:~        -  Participants will be screened with a medical history and blood and urine tests.~        -  Nurses will put an intravenous (IV) line into an arm or hand vein. It will stay in for~          several hours during the magnetic resonance imaging (MRI) and CT scans. Through this IV,~          blood will be taken, dye will be injected, and medicine will be given.~        -  Participants may have a CT scan of the heart, head, chest, abdomen, and/or pelvis.~          Participants will lie on their back on a table. The table will slide into a donut-shaped~          machine. An X-ray tube will move around the body, taking pictures.~        -  Participants may be given a drug called a beta blocker by mouth or through the IV tube.~        -  Participants heart rate and blood pressure will be monitored.~        -  Participants may have an MRI scan. The MRI is a large hollow tube. The participant will~          lie on a table that will be moved into the tube, which contains a magnetic field. When~          the imaging starts, a thumping sound will be heard. Headphones or earplugs will be~          provided to muffle the sound.~        -  Participants will give blood samples.~   "
101219|NCT02242435|"~     In this Phase III clinical trial, approximately 320 eligible patients with OA of the knee~     will receive Ampion™ 4 mL or Saline 4 mL (1:1) administered as three IA injections, 2 weeks~     apart at Day 0, Week 2, and Week 4.~   "
101220|NCT02242422|"~     The aim of this study was to identify the serial changes in lower urinary tract symptoms~     (LUTS), urine flow and bladder voiding efficiency after transobturator tape (TOT) surgery for~     treatment of female stress urinary incontinence.~   "
101221|NCT02242409|"~     A Phase II trial of gemcitabine plus nab-paclitaxel in the second line setting~   "
101222|NCT02242396|"~     The primary objective was to evaluate, through the use of Home blood pressure monitoring~     (HBPM), the degree of BP control in the early morning hours after 8 weeks of treatment in~     patients with essential hypertension under treatment with Micardis®, Telmisartan or Micardis~     Plus®, Telmisartan hydrochlorothiazide.~      The co-primary endpoints were the degree of BP control, and change from baseline until study~     end in mean systolic blood pressure (mSBP) and mean diastolic blood pressure (mDBP) HBPM in~     the early morning hours after 8 weeks of treatment with Micardis®, Telmisartan or Micardis~     Plus®, Telmisartan hydrochlorothiazide.~      Secondary endpoints were office BP control rates, office BP response rates, and reduction in~     mSBP and mDBP Office blood pressure measurement (OBPM) from baseline to final visit,~     discontinuations and tolerability~   "
101223|NCT02242383|"~     To evaluate efficacy and tolerability of Micardis® / MicardisPlus® under usual daily-practice~     prescribing conditions with a special emphasis on controlling morning blood pressure~   "
101224|NCT02242370|"~     Study to assess the effect of Telmisartan on diastolic and systolic blood pressure and to~     establish the effect on patient's quality of life scores.~   "
101225|NCT02242357|"~     Study to evaluate efficacy and tolerability of Micardis®/Micardis® Plus under usual~     daily-practice prescribing conditions in hypertensive patients~   "
101226|NCT02242344|"~     Study to assess the blood pressure lowering effects of two doses of telmisartan over a~     four-week treatment period; to determine potentially effective doses for pediatric patients~     for future studies; to assess the safety and tolerability of two doses of telmisartan.~      Pharmacokinetic objectives included the determination of the steady-state pharmacokinetics of~     telmisartan in children and adolescents aged 6 to <18 years, and to determine if age-related~     differences exist~   "
101227|NCT02242331|"~     This post-marketing surveillance study is designed to supplement under conditions of normal~     clinical practice data on safety, tolerability and efficacy of Micardis® collected in~     clinical studies with special emphasis on the control of blood pressure in the morning before~     intake of the next antihypertensive drug~   "
101228|NCT02242318|"~     The primary aim of the trial is to compare telmisartan 80 mg to valsartan 160 mg in lowering~     diastolic blood pressure in patients who missed a dose of their medication, as measured by~     ABPM (change from baseline in mean DBP over 24 hours), and to compare telmisartan 80 mg to~     valsartan 160 mg in lowering DBP during the last six hours of the dosing interval at the end~     of a 6 to 8-week treatment period, as measured by ABPM (change from baseline)~   "
101235|NCT02242227|"~     The primary objective of this trial was to establish non-inferiority of lung function~     response to 25 μg salmeterol, administered as the xinafoate salt, in an inhalation powder~     delivered from hard polyethylene (PE) capsules via the HandiHaler® 2 compared to Serevent®~     Diskus® (salmeterol 50 μg, administered as the xinafoate salt) following single dose~     inhalation in patients with COPD.~      The secondary objectives were to characterize the pharmacokinetics of salmeterol inhalation~     powder delivered by HandiHaler® 2 from the PE hard capsule and salmeterol xinafoate delivered~     by Serevent® Diskus®, and to compare the safety of the two pharmaceutical forms.~   "
101236|NCT02242214|"~     The design of the study is post-marketing, observational, multi-centre and open-label. The~     study does not provide treatment; only patients to whom misoprostol 200 µg vaginal delivery~     system (VDS) is prescribed may be included. All directions for medication usage and patient~     monitoring are solely at the discretion of the investigator in accordance with their usual~     practice and must be consistent with the Dutch prescribing information of misoprostol 200 µg~     VDS. No other (invasive) study-related interventions or measurements are done, other than the~     procedures routinely performed during induction of labour. No effort is expected from the~     study subjects. 150 patients from 20 Dutch centres will be included.~   "
101237|NCT02242201|"~     Total hip arthroplasty is a one of the most commonly performed surgical procedures with~     increasing numbers anticipated over the next several decades. The purpose of this study was~     to find a better way to make patients comfortable after their hip surgery. Three different~     ways of providing pain relief were compared, a peripheral nerve block in the lower back~     outside of the spinal space (using bupivacaine, a numbing medicine), or injections around the~     hip joint with one of two different medicines, either Ropivacaine or Liposomal Bupivacaine~     (Exparel®).~   "
101238|NCT02242188|"~     INTRODUCTION Exclusively breastfed infants are at risk of iron deficiency. American Academy~     of Pediatrics (AAP) recommends iron supplementation in exclusively breastfed infants~     beginning at 4 months of age. Uncertainty exists regarding the effects of iron~     supplementation during infancy on neurodevelopmental outcomes in the absence of anemia.~      AIM To establish whether psychomotor and mental development is influenced by early iron~     supplementation in healthy, non-anemic, exclusively or predominantly breastfed infants.~      METHODS Healthy term newborns will be recruited shortly after birth. If predominantly~     breastfed (>50% daily feedings) and non-anemic at 4 months, they will be randomized to~     receive either an iron supplement (approx.1mg/kg/day) or placebo until 9 months of age.~     Participants will be assessed with use of Bayley Scales of Infant and Toddler Development~     (Bayley III) at 12, 24 and 36 months of age.~   "
101239|NCT02242175|"~     Irritable bowel syndrome is characterized by abdominal discomfort and bowel habit change. It~     is increasing worldwide. But the pathophysiology of the irritable bowel syndrome is not~     proven. So, the treatment's target is the relief of the symptoms.~      Small intestinal bacterial overgrowth considered as the cause of the irritable bowel~     syndrome. Because, it is related to the postprandial abdominal discomfort and the abdominal~     discomfort could be relieved after taking antibiotics. There are several diagnostic methods~     for small intestinal bacterial overgrowth. hydrogen breath test is non-invasive method for~     diagnosis of the small intestinal bacterial overgrowth. But, there is no standardized cut-off~     value for the hydrogen breath test. So, we want to compare the hydrogen breath test between~     the irritable bowel syndrome patients and normal people. And then, we want to analyze the~     efficacy of hydrogen breath test for the diagnosis of irritable bowel syndrome.~   "
101240|NCT02242162|"~     Respiratory failure is the main death cause in muscular diseases. Non-invasive and volitional~     measures of inspiratory muscles strength include the nasal pressure with an occluded nostril~     and the maximal inspiratory pressure (PImax).Unfortunately, volitional maneuvers depend of~     patient effort. The mean of this reseach is to validate a non-invasive and non-volitional~     technique to evaluate diaphragm strength at muscular diseases patients.The methdology consist~     to compar PImax measure to nerves magnetical stimulation maneuvers measure.~   "
101241|NCT02242149|"~     This study is conducted to test the hypothesis that in uncontrolled type 2 diabetic adults~     treatment with diacerein will improve glycemic control and will reduce liver fat within a 24~     month period.~   "
101242|NCT02242136|"~     Soldiers deployed in peace-keeping missions as well as ex-combatants in conflict or former~     conflict regions were and are often exposed to multiple traumatic events and situations in~     which they are forced to engage in violent behavior. The treatment program Formation,~     Orientation and Rehabilitation by means of Narrative Exposure Therapy (FORNET) is a~     short-term, culturally sensitive treatment approach that aims to reduce Posttraumatic Stress~     Disorder (PTSD) symptoms as well as the risk to engage in uncontrolled violent behavior.~     Addressing trauma-related mental disorders as well as emotions related to aggression by means~     of FORNET is expected to facilitate reintegration in civil life and reduce uncontrolled~     violence.~      The investigators want to provide evidence, that FORNET is an effective and efficient module~     to assist soldiers after deployment in Somalia and/or male and female ex-combatants who~     fought in the civil war in Burundi. In addition the investigators aim to explore how~     traumatic incidences and maltreatment during childhood may influence treatment outcomes.~   "
101243|NCT02242123|"~     Celiac disease (CD) is a chronic immune-mediated disorder that occurs in genetically~     predisposed populations. Patients affected by the disease may be asymptomatic or manifest~     classic malabsorption symptoms of diarrhea, steatorrhea, abdominal pain, and weight loss~     after gluten ingestion (and related derivatives found in other grains). Diagnosis and~     screening begin with the use of serologic tests, i.e. IgA anti-tissue transglutaminase (tTG)~     and IgA anti-endomysial antibodies (EmA). Duodenal biopsy, still considered by many as the~     criterion necessary for diagnosis, demonstrates the pathologic findings of small intestinal~     villous atrophy, crypt hyperplasia, and intraepithelial lymphocytosis that occur on exposure~     to dietary gluten. Genetic tests, revealing permissive haplotypes, may be helpful in~     identifying susceptible individuals. CD diagnosis is still anchored to the criteria~     established by the European Society of Pediatric Gastroenterology Hepatology and Nutrition in~     1990. These require the mandatory presence of (a) villous atrophy with crypt hyperplasia and~     increased intraepithelial lymphocytes (IELs) count when the patient is eating gluten, and (b)~     a full clinical remission after elimination of gluten from the diet. As a consequence,~     patients with minimal or no intestinal histology lesions pose a considerable problem, as~     serum anti-tTG and EmA are known to be often negative, or weakly positive, in patients with~     CD with mild intestinal damage. The investigators, in 2002, measured anti-tTG antibody in the~     culture medium of intestinal biopsy specimens from patients with suspected CD and evaluated~     the relationship between antibody production and severity of intestinal mucosal damage, and~     demonstrated that anti-tTG assay of the culture medium of biopsy specimens can improve the~     accuracy of CD diagnosis in patients negative for serum antibodies. The same investigators,~     in 2011, evaluated the diagnostic accuracy of EmA assay in the culture medium of intestinal~     biopsies for CD diagnosis and demonstrated that EmA assay in the culture medium had a higher~     sensitivity and specificity than serum EmA and anti-tTG assay. The present study is performed~     to investigate the clinical usefulness of the in vitro production of EmA in CD diagnosis in a~     large number of consecutive adult patients with suspected CD and weakly positive [e.g. 2-3xN]~     serum anti-tTG.~   "
101245|NCT02242097|"~     This study is being done to see whether or not a drug called ibrutinib can be given to~     patients with mantle cell lymphoma (MCL) as maintenance therapy after induction chemotherapy.~     This drug blocks an enzyme that affects how the lymphocytes grow and survive. The~     investigators hope to learn how safe and effective ibrutinib is for treating patients with~     MCL after responding to induction chemotherapy.~   "
101246|NCT02242084|"~     Ischemic stroke of the spinal cord is a rare disease accounting for about 1% of all ischemic~     events in the central nervous system (CNS). In most cases the consequences are catastrophic,~     with a high rate of severe functional disability and mortality rate up to 30%.~      Ischemic stroke of the spinal cord can arise from:~        1. Dissection of the aorta.~        2. Aneurism in the aorta.~        3. Atherosclerotic disease of the aorta or vertebral arteries.~        4. Spinal surgeries.~        5. Spinal AVM.~        6. Embolism from cardiac origin.~        7. Occlusion of radicular artery. Onset is usually sudden, reaching maximal intensity in~          hours until the patient becomes paralyzed in two or in all four limbs. In most cases the~          damage is in the Anterior Spinal Artery (ASA). The disease is expressed with motor~          weakness accompanied by disturbance of temperature and superficial sensation, urinary~          retention or bowel disorder, with preserved position and vibration sense.~      The differential diagnosis of ischemic spinal cord includes diseases such as acute myelitis~     of the spinal cord or acute demyelinating polyneuropathy like Guillan Barree Syndrome (GBS).~     Therefore in order to reach the appropriate diagnosis in most cases an urgent MRI of the~     spinal cord is necessary upon arrival in the emergency department.~      One of the treatments to acute ischemic stroke is providing thrombolysis. As tested and~     validated in numerous studies for ischemic events in the brain, until today no validated~     study in ischemic spinal stroke using thrombolysis has been completed.~   "
101247|NCT02242071|"~     The effect of autologous bone marrow mononuclear cells on Motor Neuron Disease/Amyotrophic~     Lateral Sclerosis patients.~   "
101248|NCT02242058|"~     There has been little progress for effective treatment of pain in sickle cell disease (SCD)~     patients. Many organizations have recognized that understanding the causes and reducing the~     burden of pain in SCD is critical in order to improve the quality of life in SCD patients. As~     patients with SCD face the challenge of living with both acute and chronic pain which is~     often improperly treated, our translational and interdisciplinary project aims to identify~     objective measures of pain sensitivity and its biochemical and genetic correlates. We~     hypothesize that SCD patients will have decreased tolerance to thermal and electrical~     stimuli.~   "
101249|NCT02242045|"~     The primary objective of this study is to evaluate the 28-day safety, tolerability, and~     pharmacokinetics (PK) of idelalisib in Japanese participants with relapsed or refractory~     indolent non-Hodgkin lymphoma (iNHL) or chronic lymphocytic leukemia (CLL).~   "
101250|NCT02242032|"~     The purpose of this study is to assess the safety and tolerability of P-321 Ophthalmic~     Solution in subjects with mild to moderate dry eye disease.~   "
101251|NCT02242019|"~     The purpose of this study is to determine whether low level laser light therapy is effective~     in the treatment of toenail onychomycosis.~   "
101252|NCT02242006|"~     Severe acute kidney injury (AKI) is a common complication of critical illness affecting~     almost half of all patients with septic shock. Extracorporeal renal replacement therapy is a~     cornerstone in the management of AKI in these patients. Options for renal replacement therapy~     include continuous renal replacement (CRRT) therapy, intermittent dialysis (IHD) or a hybrid~     form of the two called sustained low efficiency dialysis (SLED). Globally there is a push to~     switch from traditional CRRT to SLED. Although there are resource and financial comparative~     benefits to SLED there is almost no literature describing how to dose antimicrobials (or~     other drugs for that matter). It appears that drug clearance on SLED may be more efficient~     than CRRT but not as efficient as IHD making extrapolation from these bodies of literature~     inappropriate for SLED. The investigators are proposing to conduct the population~     pharmacokinetic studies for the three most commonly used antimicrobials in critically ill~     patients receiving SLED therapy (piperacillin-tazobactam, meropenem and vancomycin).~     Population pharmacokinetic modeling of these drugs will provide estimates and sources of~     variability around pharmacokinetic parameters that will subsequently be used for Monte Carlo~     simulation to determine the most appropriate dosing regimens to achieve therapeutic targets~     while minimizing the risk of toxicity.~   "
101253|NCT02241993|"~     The purpose of the study is to test the accuracy benefit of having two glucose sensors (over~     one sensor alone) when they are positioned: 2mm, 10mm, 20mm, or 30mm apart. It is not yet~     known how close two sensors can be and still work correctly.~   "
101254|NCT02241980|"~     Evaluation of patients' methodology and ability to select an economical and ideal Medicare~     Part D prescription drug plan (PDP).~   "
101255|NCT02241967|"~     The proper control of acute and chronic pain is one of the most important areas in health~     care. Despite the profound advances in neuroscience over the past 20 years, the investigators~     still largely use opiate narcotics, much as was done in the Civil War. Total knee~     arthroplasty (TKA) is one of the most common orthopedic procedures performed 1. While knee~     pain is often a complaint that precedes TKA, the procedure itself is associated with~     considerable post-operative pain lasting days to weeks. Adequate postoperative pain control~     is an important factor in determining recovery time and hospital length of stay. New~     analgesic strategies are needed that can be used adjunctively to existing strategies with the~     potential to reduce reliance on opioid analgesia. Several novel brain stimulation~     technologies including transcranial magnetic stimulation (TMS) and transcranial direct~     current stimulation (tDCS) are beginning to demonstrate promise as treatments for a variety~     of pain conditions. Electricity has no metabolite or other residue, and can be delivered with~     minimal discomfort and without problems associated with drug-drug interactions. In two~     independent preliminary pilot studies, the Investigators have shown that tDCS can reduce~     post-operative PCA use by as much as 46% while simultaneously reducing subjective pain~     ratings. The present study aims to determine the effects of transcranial direct current~     stimulation (tDCS) on post-operative pain, patient-controlled analgesia (PCA) use, and~     post-surgical complications during the 48-hour post-operative period following total knee~     arthroplasty.~   "
101267|NCT02241811|"~     Chronic foot wounds which is very difficult to treat are common especially in diabetic and~     peripheral arterial or venous insufficiency patients. This research is aim to observe the~     foot wound's recovery with 3% Sodium pentaborate pentahydrate hydrogel.~   "
101268|NCT02241798|"~     The primary goal of the study is to assess the effect of pre-oxygenation on oxygen and carbon~     dioxide levels during seizures in patients admitted at the Epilepsy Monitoring Unit (EMU).~     The investigators hypothesize that providing oxygen prior to seizures will help eliminate the~     drops in changes seen during seizures, such as the drop in oxygen saturation and increase in~     carbon dioxide levels.~      Research will be done on patients that are admitted to the EMU specifically to have seizures~     occur and to be recorded on video electroencephalography (vEEG), and the only research~     intervention will be the use of oxygen prior to some of the seizures.~      The importance of this research relates to the phenomenon of sudden unexplained death in~     epilepsy patients (SUDEP). SUDEP cases are typically patients with epilepsy who are found~     dead by their families in the morning, without a clear cause for death. The risk of SUDEP is~     as high as 9.3 per 1000 person-years (Shorvon and Tomson 2011). There may be multiple~     mechanisms for SUDEP to occur, however a leading hypothesis is a decrease in ventilation~     during the seizure leading to hypoxia. Blood oxygen saturation levels have been found to~     decrease significantly in 25-50% of patients during or shortly after a seizure while being~     monitored in hospitals. In rare situations, a significantly lowered oxygen level may trigger~     a cascade of events from which the body may not be able to recover, leading to SUDEP. In~     animal models, providing oxygen prior to seizures occurring has been shown to eliminate~     oxygen desaturation, but more importantly eliminate mortality in animals prone to death due~     to seizures.~      Pre-oxygenation is a standard procedure during rapid-sequence induction anesthesia as it~     reduces the risk of oxygen desaturation during the apneic period of the procedure. On room~     air, the estimated duration of safe apnea is 1 minute, but this can increase to 8 minutes~     following pre-treatment with high FiO2 (Weingart and Levitan 2012). This is primarily due to~     oxygen replacing nitrogen within alveoli, creating a reservoir of oxygen within the lungs~     from which transfer to the bloodstream can continue despite the lack of ventilation. The~     apneic episode during seizures should benefit from the same principle.~      The main purpose of the Epilepsy Monitoring Unit (EMU) is to evaluate patients to better~     characterize seizures, to identify the main seizure focus. In addition to standard EEG with~     electrodes on the scalp, some patients require invasive localization of the epileptic focus~     by surgically placing electrodes within the skull (often referred to as GRID patients) on or~     within the brain, with the goal of being able to resect the area that is causing seizures. To~     identify where seizure originate electrically, it requires that seizures occur during the~     vEEG procedure. To provoke seizures, medications are typically lowered, and both partial~     seizures and those with secondary generalization to full tonic-clonic (GTC) seizures will~     occur. Prior research has shows that oxygen desaturation below 90% occurs with some complex~     partial seizures, but hypoxia is more common and more profound with GTCs. Some centers use~     oxygen saturation and CO2 monitors as their standard of care, and at NYULMC the investigators~     also have the capability for both for clinical usage.~      Oxygen is not currently a mandated standard-of-care, but is often provided by nasal prongs~     following seizures as part of the post-ictal nursing care, though there is no outcome data to~     support its use. It is unknown whether pre-treatment with oxygen will reduce the rate of~     oxygen desaturations clinically, as seen in animal models, and this is the goal of this~     research project.~   "
101256|NCT02241954|"~     The hypothesis of the study is that individuals with poor pulmonary function secondary to TIS~     will benefit from expansion thoracoplasty. The investigators specific aims are to:~        1. Record pulmonary function and thoracic volume of TIS patients at enrollment and with~          serial observation~        2. Offer expansion thoracoplasty therapy to TIS patients with~             1. poor pulmonary function at enrollment~             2. progressive decline in pulmonary function~             3. progressive chest wall and/or spinal deformity~             4. lack of appropriate increase in thoracic volume during growth~        3. Document efficacy of expansion thoracoplasty for TIS patients~   "
101257|NCT02241941|"~     The purpose of this study is to determine single dose pharmacokinetics of daptomycin~     consecutively in 10 patients on three different time points after severe burn injury.~   "
101258|NCT02241928|"~     The purpose of this study was to analyze the effect of autologous bone marrow mononuclear~     cells in muscular dystrophy.~   "
101259|NCT02241915|"~     Surgical site infections (SSI) are costly complications that may cause significant morbidity~     and increase the cost of care, particularly in colorectal surgery. Microbial sealants (MS)~     are a new class of wound barriers aimed at decreasing SSI, however there is only evidence of~     benefit in clean Class 1 procedures. Based on its success in Class 1 procedures, we~     hypothesized that a microbial sealant could reduce the rate of SSI by half for clean~     contaminated colorectal procedures (Class 2).~   "
101260|NCT02241902|"~     The aim of this study was to identify serial changes in the incidence of postoperative pyuria~     after the Photoselective Vaporization of the Prostate (PVP), to determine whether the~     presence of postoperative pyuria could be correlated with surgical outcomes after surgery and~     to identify predicting factors that influence on persistent pyuria after the PVP.~   "
101261|NCT02241889|"~     Blood glucose control systems that utilize both insulin and glucagon to manage blood sugar~     are paving the way to revolutionize the management of this disease. The benefit of improved~     control of blood sugar levels compared to standard insulin pump therapy has already been~     demonstrated. However, the risk of low blood sugar in type 1 diabetes increases considerably~     during exercise. The investigators research group has shown that small doses of glucagon can~     prevent low blood sugar when used in a blood sugar control system in patients with type 1~     diabetes. However, as insulin sensitivity changes occur very rapidly during exercise, the~     ability to recognize the onset of physical activity in order to appropriately adjust the~     insulin and glucagon delivery is vital to helping prevent exercise-induced hypoglycemia.~      The purpose of this study is to test how well a new modified blood sugar control system~     controls blood sugar during exercise compared to: 1) the current system without modifications~     and 2) standard insulin pump therapy.~   "
101262|NCT02241876|"~     Head and neck cancer corresponds to tumors located in the upper aerodigestive tract, such as~     the oral cavity, pharynx and larynx. The most effective treatment consists of high dose of~     cisplatin chemotherapy and radiotherapy, however, their use is limited due to toxicities~     caused mainly by oxidative stress. The objective of this study will be evaluate the use of~     n-acetylcysteine attenuating cisplatin-induced toxicities by oxidative stress in head and~     neck cancer patients. This is a randomized double-blind placebo-controlled clinical trial~     with consecutive sampling that will be conducted at Oncology Department of Clinic Hospital /~     University of Campinas (UNICAMP). Head and neck cancer patients who will begin cisplatin~     antineoplastic treatment (80-100mg/m2 on days 1, 22 and 43) and concurrent radiotherapy will~     be included in this research. They will be studied in 2 groups (n-acetylcysteine and~     placebo). All patients will be evaluated in relation to cisplatin induced hematologic and~     gastrointestinal disorders, nephrotoxicity, ototoxicity, and hepatotoxicity; plasmatic and~     cellular oxidative stress; quality of life; and pharmacoeconomic evaluation. Results will be~     statistically analysed using Chi-square, Fisher, Mann-Whitney, and ANOVA for repeated~     measures tests (p<0.05.)~   "
101263|NCT02241863|"~     Despite an increasing pharmacopoeia of effective medications for the treatment of bipolar~     disorder, patient outcomes continue to be impacted by treatment adherence. Non-adherence to~     treatments is also a major obstacle in translating efficacy in research settings into~     effectiveness in clinical practice. Non-adherence with bipolar disorder (BD) medication~     treatment dramatically worsens outcomes. Reasons for non-adherence among individuals with BD~     are multi-dimensional, and it has been suggested that a multifaceted intervention will be~     more effective. The study is aimed to assess the effectiveness of a multifaceted intervention~     on enhancing medications adherence in patients with bipolar disorders.~   "
101264|NCT02241850|"~     The objective of the study is to investigate the effect of high intensity training on maximal~     oxygen uptake according to the genetic polymorphisms in healthy Korean volunteers.~   "
101265|NCT02241837|"~     The primary objective is to assess the longterm safety of the CardioKinetix Parachute Implant~     and Delivery System in the partitioning of the left ventricle in patients with heart failure~     due to ischemic heart disease. This sub-study has the additional assessment of improvement in~     Pressure Volume Loop and corresponding MSCT to allow improved monitoring of heart improvement~     after therapy. The PV Loop Substudy studies he effects of the Parachute Implant on pressure~     and volume as functional parameters of the Left Ventricle.~   "
101266|NCT02241824|"~     Rationale~        -  Statement of the Problem. Low back pain is a significant societal problem in the United~          States, affecting approximately one-fourth of all Americans at any given time.~          Non-pharmacological therapies have not been well studied although preliminary evidence~          shows the utilization of bracing may be beneficial in reducing pain and medication~          usage.~        -  Hypotheses or Key Question. The investigators hypothesize that the use of an inelastic~          lumbar brace may decrease opioid use in chronic low back pain patients on a stable~          opioid regimen. The investigators propose to conduct a randomized controlled study to~          test our hypothesis.~        -  Specific Objectives.~      AIM 1: To evaluate the opioid consumption in chronic low back pain patients on a stable~     opioid regimen in a three armed trial, after an intervention of an in-elastic lumbar brace,~     elastic abdominal binder (standard care), and no brace (control).~      AIM 2: To evaluate changes in secondary endpoints such as pain intensity, quality of life,~     and functional capacity.~      Long Term aims: To decrease patient's chronic pain level, improve overall daily function,~     decrease overall opioid intake and improve quality of life.~   "
106304|NCT02175940|"~     This was a prospective, case-control study investigating aqueous levels of VEGF and PEDF in~     eyes with mCNV treated with IVB.~   "
101269|NCT02241785|"~     The primary objective of the study is to determine the efficacy of natalizumab (Tysabri,~     BG00002) in participants with relapsing forms of multiple sclerosis (MS) who have failed~     Gilenya or BRACET (Betaseron, Rebif, Avonex, Copaxone, Extavia, Tecfidera) as measured by the~     proportion of participants with no evidence of disease activity (NEDA) at Year 1. The~     secondary objectives in this study population are: change in total T1 hypointense and total~     T2 hyperintense lesion volume; proportion of participants with NEDA at Year 2; evaluation of~     the impact of natalizumab on annualized relapse rate (ARR); and change in Multiple Sclerosis~     Impact Scale-29 (MSIS-29) physical impact score.~   "
101270|NCT02241772|"~     A study in males and females with elevated Lp(a) to look at the effects of TA-8995 on Lp(a)~     levels.~   "
101271|NCT02241759|"~     A study in healthy males and females to see if a high single dose of TA-8995 has an effect on~     the ECG QTcF interval.~   "
101272|NCT02241746|"~     The purpose of this study is:~        -  to diagnose malnutrition in Chinese hospitalized patients with four nutritional~          screening tools: mini-nutritional assessment - short form, subjective global assessment,~          malnutrition universal screening tool and nutritional risk screening 2002.~        -  to optimize the usage of nutritional screening tools based on data-mining methods.~   "
101273|NCT02241733|"~     People with moderate to severe COPD trap air in their lungs. This lessens their ability to~     exercise. The investigators developed a computerized breathing retraining program to help~     patients empty their lungs during exercise. The investigators believe that learning to~     control breathing will help patients be more active. The purpose of this study is to test the~     effects of using breathing retraining (intervention group) versus no breathing retraining~     (control group) as part of a 12-week exercise program. The investigators are examining the~     long term effects of this training on exercise capacity and the ability to empty ones lungs~     during exercise. Patients will participate in a 12-week exercise program, with or without~     breathing retraining. They will then participate in a 42 week adherence program to maintain~     physical activity. Patient testing will be competed at baseline, 12 weeks, 6 months and 1~     year. 250 patients with moderate to severe COPD will be enrolled.~   "
101274|NCT02241720|"~     Regorafenib as a Second Line Single Agent in the Treatment of Metastatic or Advanced~     Adenocarcinoma of the Esophagus, Gastroesophageal Junction or Stomach~   "
101275|NCT02241707|"~     In this proposal, the investigators seek to determine whether a reduced compression after~     endovenous ablation procedure in treating superficial venous insufficiency affects the~     outcomes. This study involves only the use of the compression stocking post endovenous~     ablation procedure and everything else is standard according to current guidelines.~      The investigators general strategy will be to determine the role of a minimal post-operative~     compression and the status of patient satisfaction including (1) Success closure rate of the~     treated vein. (2) Less pain; (3) Easier accepted by the patients.~   "
101276|NCT02241694|"~     This survey is conducted in South America. The purpose is to identify the key psychosocial~     issues affecting patients with haemophilia.~   "
101277|NCT02241681|"~     Medium Chain Triglycerides (MCT) have been used for many years as a good source of lipid to~     decrease potential for fat malabsorption. However, the pharmacokinetics of MCT and of their~     metabolites have not been explored in details.~      This is an exploratory study aiming at determining the plasma level of MCT and their~     metabolites after oral intake of Peptamen.~   "
101278|NCT02241668|"~     The goal of this clinical research study is to learn if using a new imaging solution,~     3'-Deoxy-3'-18f-Fluorothymidine, in a positron emission tomography (PET) scan can help~     doctors determine if your brain lesion is from the tumor returning or the effects of previous~     treatments.~      The results of this imaging scan (called an FLT PET scan) will be compared to the results of~     a Magnetic Resonance Imaging scan, which you have already had or are scheduled to have~     outside of this study.~   "
101279|NCT02241655|"~     This study aims to determine whether, compared with usual anesthetic care, an~     electroencephalography-guided anesthesia protocol is effective at preventing postoperative~     delirium and its downstream effects, and improving postoperative patient reported~     health-related quality of life.~   "
101280|NCT02241642|"~     The purpose of this Clinical Investigation is to validate that the clinical use of the~     VIVASURE CLOSURE DEVICE™ is safe for the operator, patient and third parties, and to confirm~     its performance to percutaneously close femoral arterial puncture sites in the range of 18-24~     F, post endovascular procedures.~      This is a non-inferiority study based on safety. Safety will be assessed by incidence and~     severity of major complication rates directly related to the VIVASURE CLOSURE DEVICE™ up to 3~     months from implantation is no worse than those associated with cut-down and sutured close.~   "
101281|NCT02241629|"~     A double-blind, randomized, placebo controlled, multicenter, dose-finding phaseⅡclinical~     superiority study.~   "
101282|NCT02241616|"~     Liver Cirrhosis is a common pathological consequence of chronic liver disease. Hepatitis B~     Virus (HBV) is one of most etiologies of Liver cirrhosis in China. The effective inhibition~     of HBV can partially regress or reverse liver fibrosis in patients with chronic Hepatitis and~     liver cirrhosis due to HBV, however some patients keep existence or development although HBV~     DNA is under-detectable after anti-virals. Theses refractory liver fibrosis is required the~     anti-fibrotic treatment focusing on the regulation of hepatic extracellular matrix,~     especially is necessary for in the patients with advance fibrosis stage ie. liver cirrhosis.~     Fuzheng Huayu has been found to enhance the degradation of collagens in fibrotic liver and~     have a good action against liver fibrosis in patients with chronic hepatitis B. However,~     there are no high quality clinical evidences which can demonstrate if the combination of~     anti-viral and anti-fibrotic therapy can improve the reversion of refractory liver fibrosis~     in liver cirrhosis due to HBV.~      The primary objective of this study is to establish the safety and efficacy of the~     combination of Entecavir and Traditional Chinese Medicine in refractory liver fibrosis in~     liver cirrhosis due to HBV.~   "
101291|NCT02241499|"~     In this trial, patients with histologically proven adenocarcinoma of the esophagus or~     esophagogastric junction noneligible for surgery or chemoradiation with curative intent will~     be included. Primary objective is to determine the rate of improvement in dysphagia after~     palliative short course hypofractionated radiotherapy (5 x 4 Gy) followed by chemotherapy~     consisting of oxaliplatin and fluorouracil. The rate of improvement of dysphagia is evaluated~     by a 5 graded dysphagia score, and a positive change of at least 1 score is considered to be~     an improvement.~   "
101283|NCT02241603|"~     Obesity is a common problem in the Veteran population as at least 1 in 3 Veterans are obese.~     When obese people eat food they have less response in areas of the brain that sense pleasure~     (reward). Decreased pleasure response to food predicts future weight gain. It is not known if~     this poor brain response is reversible or why obese people's brains respond this way. Insulin~     in the brain regulates the brain's sensing of pleasure. As people gain weight the function of~     insulin becomes impaired. The investigators will study if impaired function of insulin is~     related to a poor brain response to food and if this brain response predicts voluntary intake~     of food and response to a diet. The investigators will also study if improving the function~     of insulin with weight loss improves the brain response. These studies will improve the~     understanding as to why weight loss is difficult and inform us if improving insulin signaling~     is a potential way to treat obesity.~   "
101284|NCT02241590|"~     Liver Cirrhosis is a common pathological consequence of chronic liver disease. Hepatitis B~     Virus (HBV) is one of most etiologies of liver cirrhosis in China. The effective inhibition~     of HBV can partially stop or reverse liver fibrosis in patients with chronic Hepatitis and~     liver cirrhosis due to HBV, and the anti-fibrotic strategy focusing on the regulation of~     hepatic extracellular matrix is still required and hopefully improve the efficacy of~     anti-virals for liver fibrotic patients with HBV, especially is necessary for in the patients~     with advance fibrosis stage ie. liver cirrhosis. Fuzheng Huayu has been found to enhance the~     degradation of collagens in fibrotic liver and have a good action against liver fibrosis in~     patients with chronic hepatitis B. However, there are no high quality clinical evidences~     which can demonstrate if the combination of anti-viral and anti-fibrotic therapy can improve~     the reversion of liver cirrhosis due to HBV.~      The primary objective of this study is to establish the safety and efficacy of the~     combination of Entecavir and Fuzheng Huayu for the reversion of liver fibrosis in patients~     with liver cirrhosis due to HBV.~   "
101285|NCT02241577|"~     This study will compare surgical and non surgical treatments of peri-implantitis.~     Peri-implantitis is an inflammation around dental implants that can lead to the loss of the~     implant over time if no treatment is established. The signs of peri-implantitis included~     bleeding of the gingiva, swelling and redness. Most of times there is no pain. Patients~     presenting with these characteristics will be included at random to one of the treatment~     groups. Those allocated to the non-surgical group will received implant cleansing after local~     anesthesia using adequate instruments. In the surgical group, patients will be submitted to a~     surgical procedure around the implant for visualization and cleansing also after local~     anesthesia. All patients will be followed over a 12-month period. The hypothesis is that~     surgical treatment is better than non-surgical treatment regarding clinical, radiographic,~     microbiological, and immunological.characteristics.~   "
101286|NCT02241564|"~     The aim of the project is to improve the overall treatment and outcome of renal, pancreas or~     liver transplanted patients who have encountered a malignancy by a structured treatment~     program for diagnosis and treatment of the malignancy, optimization of the immunosuppressive~     treatment, follow-up and evaluation of the program.~   "
101287|NCT02241551|"~     This is a prospective, randomized phase II trial. Patients diagnosed with borderline~     resectable pancreatic adenocarcinoma will be randomly assigned to one of two treatment arms,~     either mFOLFIRINOX or gemcitabine and nab-paclitaxel. After three cycles of treatment in the~     gemcitabine/nab-paclitaxel arm and 6 cycles in the mFOLFIRINOX arm, patients will be restaged~     with CT scans and if they remain borderline resectable or have improvement of their disease~     They will then proceed to SBRT followed by surgical resection.~   "
101288|NCT02241538|"~     Low back pain is a major cause of disability and absenteeism and the supervised exercise is a~     recommended treatment by the guidelines and has been cost-effective. Currently, the Pilates~     method has shown to be effective in improving pain and disability in patients with chronic~     low back pain (CLBP). However, there is still no evidence about the ideal number of sessions~     for the treatment and the interval between sessions to achieve better efficacy of this method~     for these patients. Thus, the aim of this study is to investigate the effectiveness of the~     Pilates method with different weekly frequency of sessions in the treatment of patients with~     nonspecific CLBP. Investigators will assess 296 patients of both genders, with nonspecific~     CLBP lasting more than three months and aged between 18 and 80 years. Participants will be~     randomly divided into four groups (n = 74 patients per group): Control Group will receive an~     educational booklet and no additional exercise, Pilates 1 Group will receive a program of~     exercises based on Pilates method once a week for six weeks, Pilates 2 Group will receive the~     same program of exercises twice a week for six weeks and Pilates 3 Group will receive the~     same program of exercises three times a week for six weeks. The outcomes overall disability~     (Roland Morris Disability questionnaire), specific disability (Patient-Specific Functional~     scale), kinesiophobia (Tampa scale for kinesiophobia), pain intensity (Pain Numerical Rating~     scale) and global perceived effect (Global Perceived Effect scale) will be assessed by a~     blinded assessor before, six weeks, six and 12 months after randomization. Investigators~     expect that the largest number of weekly sessions of Pilates method may influence the results~     in all analyzes (short, medium and long term), since there is a relationship between~     frequency of exercises and effect size of the treatment.~   "
101289|NCT02241525|"~     Examine the feasibility and efficacy of individually optimized uniform contrast enhancement~     in CT pulmonary angiography (CTPA) for the diagnosis of pulmonary thromboembolic disease.~   "
101290|NCT02241512|"~     Endoscopic retrograde cholangiopancreatography (ERCP) is an advanced endoscopic technique~     utilized to diagnose and treat pathologic conditions involving the ducts draining the liver~     and pancreas. Post-ERCP pancreatitis (PEP) is the most common complication following ERCP and~     occurs in approximately 11% of children undergoing the procedure. By definition it leads to~     prolongation of hospital stay or delays in care and rarely can result in long-term morbidity~     or even death. Recent adult trials have demonstrated prevention of PEP with administration of~     rectal nonsteroidal anti-inflammatory drugs (NSAIDS). To date, no studies have been performed~     in children thus no gold standard or even commonly accepted method of preventing PEP in the~     pediatric population exist. Studying an IV NSAID such as ibuprofen has distinct advantages~     over rectally administered NSAIDs in the pediatric population in that it would allow for more~     consistent weight based dosing and would have more predictable absorption compared to~     suppository. Thus, this project proposes a pilot study evaluating the effectiveness of IV~     ibuprofen at preventing PEP in the pediatric population. The design of the proposed study is~     a prospective randomized double-blind trial comparing IV Ibuprofen to placebo controls~     (normal saline) at the time of procedure in patients undergoing ERCP at Children's Medical~     Center Dallas over a two-year period. The primary outcome measurement will be development of~     PEP. Post-ERCP bleeding and change in pre- and post- procedural pain scores will also be~     measured. The hypothesis is that IV Ibuprofen administered at the time of ERCP will decrease~     rates of post-ERCP pancreatitis in pediatric patients.~   "
101292|NCT02241486|"~     The purpose of this study is to examine the efficacy and safety of sublingual fentanyl spray~     (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn~     injury.~   "
101293|NCT02241473|"~     By analyzing energetic and biomechanical basis of walking, and the subsequent changes induced~     by hypoxic vs normoxic training in obese individuals, it may optimize the use of walking in~     hypoxia to gain perspective for exercise prescription to set up training programs that aim to~     induce negative energy balance and to deal with weight management. However to the~     investigators knowledge, the analysis of changes in mechanics, energetics and efficiency of~     walking after continuous hypoxic training (CHT) has not been performed yet.~      The aims of the present study were:~        1. Comparing the changes in body composition between continuous hypoxic training (CHT) and~          similar training in normoxia; e.g. continuous normoxic training (CNT) in obese subjects.~        2. Comparing the metabolic and energetics adaptations to CHT vs CNT.~        3. Finally, comparing the associated body‐loss induced gait modification since walking~          intensity at spontaneous walking speed (Ss) is lower in CHT than in CNT.~   "
101294|NCT02241460|"~     The purpose of this study is to evaluate the efficacy of treatment with Promescent Lidocaine~     Spray compared with placebo in patients with premature ejaculation.~   "
101295|NCT02241447|"~     The purpose of this study is to narrow the gap between patients being diagnosed with severe~     aortic stenosis and those being appropriately monitored and treated. For this purpose a~     prospective survey of current practice (3 months) will be conducted followed by a six month~     period of intervention during which a variety of quality improvements measures will be~     implemented. There will then be a 3 month follow-up period during which the legacy of this~     initiative will be monitored during which no intervention will be carried out.~   "
101296|NCT02241434|"~     The purpose of this study was to study the effect of stem cell therapy in patients with~     Duchenne Muscular Dystrophy.~   "
101297|NCT02241421|"~     BACKGROUND: The relation between gut microbiota and obesity originates from animal studies,~     showing that the change of gut microbiota can induce changes in both insulin resistance and~     body composition. In addition, these studies have shown changes in gut permeability inducing~     a pro-inflammatory state, changes in adipose tissue function and inflammation, effects on~     energy harvesting and metabolism, skeletal muscle fatty acid partitioning and fat oxidation.~     Human data is lacking, although several studies suggested that the composition of the gut~     microbiota differs between lean and obese, and between diabetic and non-diabetic individuals.~      OBJECTIVE: To provide insight in the physiological significance and underlying mechanisms~     involved in the relation between gut microbiota, energy balance and insulin sensitivity in~     overweight men with impaired glucose homeostasis.~   "
101298|NCT02241408|"~     The purpose of this study is to determine the impact that treatment with a cellular~     concentrate derived from an individual's own fat, known as the stromal vascular fraction~     (SVF), has on joint pain and functionality in people with Osteoarthritis (OA). SVF contains~     components with regenerative properties, including stem cells that have shown promise for~     ameliorating specific disease conditions. This study is designed to evaluate joint pain and~     functionality changes in individuals with OA for up to 12 months following SVF treatment.~   "
101299|NCT02241395|"~     The purpose of this study was to study the effect of autologous bone marrow mononuclear cells~     on common symptoms of cerebral palsy patients.~   "
101300|NCT02241382|"~     Implantation of internal defibrillators, capable of monitoring the heart and shocking life~     threatening arrhythmias back to normal rhythm, for patients with severe heart failure~     increases the probability of survival. Arrhythmias of the atria of the heart are common in~     these patients. Administering a direct current electrical shock under anesthesia~     (cardioversion) is the method of choice to reestablish normal sinus rhythm in this instance.~     Safety and efficacy of external electrical cardioversion (CV) in patients with ICDs was~     demonstrated in several studies. Safety of internal cardioversion (shocking the heart back~     into normal rhythm via the implanted defibrillator) was described in several smaller trials.~      Performing external instead of internal cardioversion in patients with implanted ICDs is more~     feasible for most hospitals, as CV can be performed without a programming computer and an~     additional specialist present, e.g. on the intensive care ward, and device interrogation can~     be done after CV at the remote ICD/pacemaker clinic.~      No scientific data on safety and efficacy endpoints comparing internal vs external CV is~     currently available. The aim of the study is to compare external vs internal electrical~     cardioversion for atrial arrhythmias and establish a safety and efficacy profile for external~     and internal cardioversion in large cohort of ICD patients.~   "
101301|NCT02241369|"~     This is a Phase I, open-label study to evaluate the safety, tolerability, and immunogenicity~     of INO-3106 alone or in combination with INO-9012 DNA vaccines delivered by Electroporation~     to subjects with HPV6 associated aerodigestive precancerous lesions and malignancies.~   "
101302|NCT02241356|"~     Visual acuity at near improves in children with Down syndrome using bifocals~   "
101303|NCT02241343|"~     Problems affecting the veins in the legs can cause discomfort and swelling. We want to see~     how artificially and reversibly blocking the leg veins affects swelling in the lower limb.~   "
101304|NCT02241330|"~     The objective of this research is to test the efficacy of Zn biofortified wheat in increasing~     Zn status in Indian school children aged 6-12 y via a 6 month randomized controlled trial.~   "
101305|NCT02241317|"~     Development of a training concept for health care professionals (nursing and medical staff),~     according to the current guidelines on treatment of in-patients with Diabetes. Primary~     endpoint is the change in hypoglycaemia rates comparing data before and after the training.~     Hereby we can derive the effects of staff training on the quality of health care in this~     patient population.~   "
101306|NCT02241304|"~     TetraGraph is a newly developed EMG-based, quantitative, battery-powered neuromuscular~     monitoring system intended for daily clinical use. The primary aim of this clinical~     investigation is to examine the applicability (ease of use, equipment need, etc.),~     repeatability (precision or internal consistency) and performance (signal quality, accuracy~     of outcome, voltage of stimulation output before and during a stimulus) of the Tetragraph~     device in patients undergoing elective surgeries requiring neuromuscular blockade.~   "
101353|NCT02240693|"~     The study is designed to compare the effects of 4 different doses of orally administered BI~     409306 to placebo in patients with Alzheimers Disease~   "
101389|NCT02240225|"~     Assessment of health-related quality of life in COPD patients with severe chronic respiratory~     failure requires appropriate and highly specific measurement tools. We attempt to validate~     the Chinese version of the Severe Respiratory Insufficiency Questionnaire (SRI)~   "
101307|NCT02241291|"~     The aim of the CARDIOBASE Bern PCI registry is to collect baseline clinical and procedural~     data as well as to assess the clinical outcomes of all patients undergoing percutaneous~     coronary intervention (PCI) at Bern University Hospital. All patients undergoing PCI with or~     without stent implantation will be prospectively registered. Device use is according to the~     decision of the treating physician and independent of this registry. At hospital discharge~     and one year, the following outcomes will be assessed: death, cardiac death, myocardial~     infarction, stent thrombosis, repeat revascularisation, stent thrombosis, stroke, bleeding,~     renal failure and vascular complications.~   "
101308|NCT02241278|"~     The analgesic properties of ketamine are associated with its non-competitive antagonism of~     the N-methyl-D-aspartate receptor; these receptors exhibit an excitatory function on pain~     transmission and this binding seems to inhibit or reverse the central sensitization of pain.~     In the literature, the value of this anesthetic for preemptive analgesia in the control of~     postoperative pain is uncertain. The objective of this study was to ascertain whether~     preoperative low-dose ketamine reduces postoperative pain and morphine consumption in adults~     undergoing colon surgery.~      In a double-blind, randomized trial, 48 patients were studied. Patients in the ketamine group~     received 0.5 mg/kg intravenous ketamine before surgical incision, while the control group~     received normal saline. The postoperative analgesia was achieved with a continuous infusion~     of morphine at 0.015 mg∙kgˉ¹∙hˉ¹ with the possibility of 0.02 mg/kg bolus every 10 min. Pain~     was assessed using the Visual Analog Scale (VAS), morphine consumption, and hemodynamic~     parameters at 0, 1, 2, 4, 8, 12, 16, and 24 hours postoperatively. We quantified times to~     rescue analgesic (Paracetamol), adverse effects and patient satisfaction.~   "
101309|NCT02241265|"~     The investigators hypothesis is that there will be improvement in FEV1 in patients with~     severe asthma.~   "
101310|NCT02241252|"~     This study will validate the recording accuracy of a specific electrical interval of the~     heart, the QT interval, between an iPhone rhythm strip recording and a traditional 12-lead~     electrocardiogram (ECG). These measurements will occur in hospitalized patients that are~     starting either sotalol or dofetilide, since both of these medications can prolong the QT~     interval.~   "
101311|NCT02241239|"~     There are many risk prediction models. And their estimates are different. This study aimed to~     investigate the differences between the estimates of Fuwai and Reynolds risk model in~     Chinese, and investigate the reason for the differences.~   "
101312|NCT02241226|"~     It is becoming increasingly recognized in the literature that ancient practices for~     wellbeing, including meditation, yoga, and specific herbs, can improve health and promote~     longevity. While studies have documented such effects for a variety of individual practices~     for wellbeing, few studies have taken a more whole systems approach that is simultaneously~     inclusive of numerous practices. This intervention study, the Self-Directed Biological~     Transformation Initiative, will examine the effects of a comprehensive whole systems~     approach to wellbeing on key biochemical, physiological, and psychosocial endpoints.~     Participants randomized to the Perfect Health program at the Chopra Center for Wellbeing will~     be compared to individuals not taking the program.~   "
101313|NCT02241213|"~     Aphasia is one of the most disabling complications in language production in patients with~     left hemisphere stroke. About 19% of patients who experience aphasia may have a spontaneously~     recovery after several weeks or months. Some studies have reported that repetitive low~     frequency Transcranial Magnetic Stimulation (TMS-r) in patients with ischemic stroke~     generates left modulation of cortical excitability by facilitating and promoting functional~     reorganization and recovery of language production. In spite of this, most of the studies in~     patients with post-stroke aphasia, are small cases series without controls that correspond to~     a descriptive design and does not perform long-term follow up. Currently the population is~     heterogeneous respect to etiology, type of stroke and aphasia severity; also several authors~     have concluded that the exact location of the site, would be possible through the~     neuronavigation technique, to obtain better results.~      OVERALL OBJECTIVE Determine the efficacy of repetitive low-frequency TMS on oral language~     recovery in post-ischemic stroke patients with non-fluent aphasia~      ESPECIFIC OBJETIVES~        -  Estimate the effect of repetitiveTMS treatment on right Lowe Frontal Gyrus (GFI), in the~          evolution of the neuropsychological language test results in patients with non-fluent~          aphasia, compared to placebo.~        -  Describe the behavior of depression and anxiety levels in both treatment groups (active~          and placebo), through Zung anxiety and depression test, to establish their correlation~          with production testing language.~        -  Evaluate the effect of repetitiveTMS technique compared to placebo, on the overall~          functionality of the subject through Barthel scale.~        -  Describe the impact of language behavior on the quality of life of patients treated with~          placebo and active EMT, assessed by the EuroQol test.~      METHODOLOGY A placebo double blind controlled and randomize trial, to evaluate the efficacy~     of low frequency EMT-r in language recovery in 100 patients with first ischemic stroke event~     among the first 4-8 months postinfarction and non-fluent aphasia. The patient will agree and~     will sign the informed consent, in order to application aphasia diagnosis Boston test,~     Edinburgh test, Barthel scale, Zung anxiety and depression test, and EuroQol scale, Neuropsi.~     Subsequently the subjects will be randomizate to any of two arms of the study. A week before~     the start of the stimulation sessions, the following tests will be applied to assess language~     production: Boston Test and Verbal Fluency (FAS). Each patient will have a daily session~     EMT-r low-frequency active or inactive coil with a biphasic stimulator pulses applied for ten~     days in two weeks on the triangular area - homologous to injury Lower Front Gyrus (LFG),~     (right brain hemisphere). Complete the treatment schedule of two weeks, the language~     production will be evaluate again, and also scales as Barthel an Rankin-m, Zung anxiety and~     depression and EuroQol. This monitoring will be achieved in five stages: after one week, one~     month, 4 months, 8 months and 12 months post-stimulation, with the intention of determining~     the duration and effectiveness effects in language production of the EMT-r.~   "
101314|NCT02241200|"~     The main purpose of the study is to determine whether the test product and the reference~     product are bioequivalent based on the pharmacokinetics after administration of ug/kg as a~     single intravenous dose and as a single subcutaneous dose of each of the formulations. The~     study is consisted of randomization, 2 parts, 4 treatments, 2 way cross over.~   "
101315|NCT02241187|"~     This study has several purposes. DCE-MRI will be used to image the tumor. Safety of cetuximab~     given before surgery will be studied. Cetuximab delivery to the tumor will be studied. In~     Stage 2 of this study, the safety of cetuximab and PEGPH20 given before surgery will be~     studied. Also, the effects of PEGPH20 on tumors will be studied.~   "
101316|NCT02241174|"~     This study will determine the safety and efficacy of diluted bleach bath solution as final~     rinse on the reduction of Staphylococcus aureus colonization among children and adult~     Filipinos with mild to moderate atopic dermatitis..~   "
101317|NCT02241161|"~     Aim of the study was to evaluate the soothing and re-epithelizing activity of a single~     application of topical products on experimentally induced erythema by skin stripping on the~     forearm (volar surface) of 20 healthy volunteers. In particular the activity of the following~     three cosmetic products and the relative combinations (cream and serum) were assessed:~     rejuvenating cream, rejuvenating serum, antioxidant serum~   "
101318|NCT02241148|"~     The investigators will include patients attending outpatient clinic in the area of~     Orthopedics and Traumatology of our hospital with a diagnosis of unilateral Patellofemoral~     Pain Syndrome. Inclusion criteria are: age between fifteen and thirty-five years, presenting~     unilateral PFPS with six months of evolution, presenting anterior or retro knee pain that~     presents itself when undergoing two or more of the following activities: squatting, running,~     kneeling, jumping, or climbing stairs; physically active patients, with at least thirty~     minutes of physical activity at least three times per week. Exclusion criteria include~     patients with previous knee surgeries, chronic pain with more than one year of evolution,~     pregnancy or suspected pregnancy, application of intra-articular steroids in the three months~     prior to their evaluation, patients with meniscal injuries, ligament or intra-articular knee~     structures, degenerative diseases such as diabetes, rheumatoid arthritis, OA of the knee, hip~     or ankle, history of dislocation or subluxation of patella, Osgood Schlatter syndrome and~     patellar tendinitis or quadriceps.~      The investigators will divide patients into two groups. The control group will receive~     treatment with acetaminophen and physical therapy rehabilitation, closed chain exercises and~     stretches at home intended for the strengthening of quadriceps, abductors and internal~     rotators of the hip for the duration of six weeks. The experimental treatment group will~     receive the above plus the application of the technique NUCAP Medical Upper Knee Spider ®~     Kinesio taping on the affected knee. Both groups will be evaluated by an external~     consultation. They will be assessed by the Tegner Activity Scale, the Kujala score of the~     WOMAC and visual analog scale (VAS) for pain assessment; these scales will be applied at the~     beginning, third and sixth week. The patients in the experimental group will be quoted each~     week to change the tape. The control group will be quoted at the beginning, at three weeks~     and after six weeks. During the first appointment we will take patients anthropometric~     measurements (weight, height, BMI) as well as general information. Radiographic studies~     (anteroposterior and lateral knee, plus the projection Merchant) will be sought to rule out~     other diseases and see the degree of contact of the patella on the patellofemoral joint. All~     patients will receive an explanation about their illness, and a booklet with the required~     exercises as well as their frequency.~      For patients to be included in the group of Spider ® Taping, Kinesio Tape pre-cut strips that~     were placed inferior to the head with no pressure applied, then two bands are placed at the~     ends of the tape and crossed on the edges of the patella and ending at the thigh to finish~     applying moderate tension to place them, then two strips were placed at each end of the edges~     of the first and second tape without applying pressure. The tapes can last up to five days on~     the extremities while maintaining their purpose, patients included in this group will be~     summoned each week to remove the tapes and place new ones.~   "
101319|NCT02241135|"~     The purpose of this trial is to assess the safety and immunogenicity of an investigational~     RNActive® rabies vaccine (CV7201) in healthy adults.~   "
103388|NCT02214108|"~     The purpose of this study is to determine the effect of interactive video game in management~     of overweight in children. The investigators will evaluate the effect of product versus~     standard physical activity.~   "
101320|NCT02241122|"~     Prostate cancer has been the most common neoplastic disease in men in Finland over the last~     ten years. Prostate-specific antigen (PSA) plays an important role in screening of prostate~     cancer. However, PSA has a limited sensitivity and specificity for prostate cancer detection.~     Commonly, the diagnosis of prostate cancer is done by transrectal ultrasonography (TRUS)~     guided biopsy. Because of the low accuracy of TRUS a systematic biopsy is usually performed~     instead of targeted TRUS biopsy. As biopsy carries a significant risk of complications, there~     is an increasing interest in developing more accurate non-invasive imaging modalities.~      This prospective multi-institutional study will enroll 400 men with clinical suspicion of~     prostate cancer due to higher serum level of PSA than 2.5 ng/ml and/or abnormal digital~     rectal examination. Anatomical magnetic resonance imaging (MRI) and diffusion weighted~     imaging (DWI) at 1.5/3 Tesla (T) magnetic field using surface coils will be used to~     non-invasively predict the presence or absence of prostate cancer. Targeted TRUS guided~     biopsy based on MRI findings will be performed in addition to routine twelve core TRUS~     biopsy. Moreover, selected serum and urine biomarkers as well as biomarkers extracted from~     fresh biopsy sample will be collected and correlated with the presence or absence of prostate~     cancer.~   "
101321|NCT02241109|"~     Aortic stenosis is the most common valvular heart disease and an important public-health~     problem. Surgical or interventional aortic valve replacement are based on symptoms and~     measures of valvular and ventricular function using echocardiography.There is no uniform~     pattern of progression. Instead, marked differences not only between individuals, but also~     during the time course of the disease can be observed.~      Several prospective studies have been performed to enhance the predictability of disease~     behavior. Individually it is still prone to large errors and hard to predict aortic stenosis~     progression. Therefore, in patients with aortic sclerosis without severe stenosis, it is~     desirable to find a strong predictor of rapid disease progression. This would allow~     anticipating cardiovascular deterioration by identifying individuals at particular risk.~      Study Hypothesis~      In patients with aortic sclerosis, increased serum calcification propensity, as measured by~     the T50-Test, is related to the amount of stenosis progression in one year.~   "
101322|NCT02241096|"~     To determine safe concentration level of lidocaine infusion in children.~   "
101323|NCT02241083|"~     Vasopressors may be needed after head and neck microvascular reconstructions to maintain~     sufficient mean arterial pressure. This is crucial for the flap survival. The study~     hypothesis is that norepinephrine and dopamine used as vasopressors do not affect flap tissue~     oxygen level and microdialysate metabolites.~   "
101324|NCT02241070|"~     The aims of the study are to determine the effectiveness of Mindfulness-Based Interventionas~     a workplace health promotion program on psychological distress, prolonged fatigue, job strain~     (job control and job demand), and perceived stress and to explore the influences of personal~     characteristics (including gender, age, education, and occupation) on the outcomes of the~     intervention with time.~   "
101325|NCT02241057|"~     This is an open-label study. A total of approximately 60 subjects will be randomly assigned~     to receive either the heat patch (30 subjects) with a temperature probe/skin reference probe~     or a heat patch (30 subjects) alone. The study will consist of 2 visits.~   "
101326|NCT02241044|"~     Background:~      A second endoscopic method added to injection therapy is recommended for high-risk bleeding~     peptic ulcers. Many endoscopic devices have been proved as useful hemostatic instruments,~     whereas the hemostatic efficacy of argon plasma coagulation (APC) has not been widely~     investigated.~      Aim:~      This study was designed to know whether additional APC treatment could influence the~     hemostatic efficacy after endoscopic injection therapy in treating high-risk bleeding ulcers.~      Methods:~      From October 2010 to January 2012, eligible patients who had high-risk bleeding ulcers were~     admitted to our hospital. They prospectively randomly underwent either APC therapy plus~     distilled water injection or distilled water injection alone. Pantoprazole infusion was~     conducted during the fasting period after endoscopy and orally for 8 weeks to encourage ulcer~     healing. Episodes of rebleeding were retreated with endoscopic combination therapy. Patients~     who did not benefit from retreatment underwent emergency surgery or transarterial~     embolization (TAE).~   "
101327|NCT02241031|"~     The purpose of this study is to evaluate the efficacy of ex vivo generated megakaryocytic~     progenitor cells (MPs) in prophylaxis and treatment of thrombocytopenia caused by~     chemotherapy in patients with acute leukemia (AL).~   "
101328|NCT02241018|"~     The purpose of this study is to compare the efficacy of CD25 monoclonal antibody and~     calcineurin inhibitors with or without mesenchymal stem cells (MSCs) in treating patients~     with steroid-resistant acute graft-versus-host disease (aGVHD) after allogeneic hematopoietic~     stem cell transplantation.~   "
101329|NCT02241005|"~     Healthcare-associated infections (HAI) are associated with substantial morbidity, mortality~     and health-care costs in children undergoing hematopoietic stem cell transplantation (HSCT).~     These infections are often caused by a patient's own microbial flora. Hence reduction of~     microbes in the skin could lessen the risk of contamination of central venous catheters,~     Central Line Associated Blood-Stream Infections (CLABSI), and bacteremia due to compromise of~     skin integrity.~      Theraworx™ (herein referred to as experimental wipes) is a self-drying, leave on cleansing~     agent that combines a specialized surfactant with skin healthy ingredients, including aloe,~     allantoin, vitamin E, and silver, which is the main antimicrobial ingredient. It can be used~     on all parts of the body including burns, abraded skin, and on patients with skin~     graft-versus-host-disease (GVHD). It is user friendly and obviates the risk of antimicrobial~     resistance. Microbiologic studies have shown several log fold reduction of bacteria including~     vancomycin-resistant enterococci, carbapenem resistant Escherichia coli, and activity against~     Staphylococcus aureus, Enterococcus faecalis, Clostridium difficile, Candida albicans, and~     viruses including influenza A and Herpes Simplex. There is no data regarding the use of~     Theraworx™ (experimental) bath wipes in children or the HSCT population.~      Researchers at St. Jude Children's Research Hospital want to learn if daily bathing with~     experimental bath wipes will be well tolerated and associated with reduction in microbial~     skin colonization in this population.~   "
101330|NCT02240992|"~     The purpose of this study is to compare the efficacy of mesenchymal stem cells (MSCs) with or~     without granulocyte colony-stimulating factor (G-CSF) mobilized peripheral stem cells (PBSC)~     in treating patients experiencing poor graft function or delayed platelet engraftment after~     allogeneic hematopoietic stem cell transplantation.~   "
101331|NCT02240979|"~     The purpose of the study is to evaluate a new way to examine cardiac function, using software~     developed at Caltech. The experimental device is software loaded on an iPhone. The iPhone is~     used to capture a pulse (waveform) by simply placing the iPhone lightly over the neck where~     the carotid pulse can be felt. In this study the information collected from the iPhone app is~     compared to cardiac function data obtained from the current gold standard for measuring~     cardiac function, cardiac magnetic resonance imaging (MRI). Subjects referred from~     cardiologists will also generally have echocardiography information available for comparison~     with the iPhone app. For the study, subjects will have completely non-invasive studies done~     in one setting: The iPhone app to capture the waveforms (over carotid and radial (wrist)~     arteries), tonometry (another non-invasive method using a modified stethoscope), standard~     pulse oximetry, followed by a 30 minute MRI examination of the heart. A second complete study~     will be done about 6 months after the first. The complete study session takes about 1.5~     hours.~   "
101332|NCT02240966|"~     The purpose of this study is to investigate the prevalence of signs and symptoms of~     hypogonadism in three groups of testicular cancer survivors.~   "
101333|NCT02240953|"~     Prosthetic valve thrombosis is a serious complication with high mortality and morbidity.~     However, the best anticoagulant treatment strategies for patients with prosthetic heart valve~     thrombosis have not been fully known. In this study the investigators wanted to identify the~     most effective and safe regimen among different anticoagulant regimens.~   "
101334|NCT02240940|"~     The design of this study is a multi-center, prospective, single-arm clinical trial to~     evaluate the safety and efficacy of the Parachute percutaneous left ventricle partitioning~     system. The purpose of this trial is to use the Parachute percutaneous left ventricular~     partitioning system to isolate the malfunctioning portion of the left ventricle in patients~     with symptoms of heart failure due to ischemic heart disease and provide the data required to~     gain Chinese regulatory approval.~   "
101335|NCT02240927|"~     Pregnancy is associated with increased risk of thrombosis among women with mechanical~     prosthetic heart valves.However, the best anticoagulant treatment strategies for pregnant~     patients with prosthetic heart valves have been controversial. In this study the~     investigators wanted to identify the most effective and safe regimen among different~     anticoagulant regimens.~   "
101336|NCT02240914|"~     -  Determine the sensitivity, specificity and accuracy of vascular ultrasound, using direct~          and indirect ultrasonographic signs, in the obstructive diseases of iliac venous~          segment, in patients with advanced chronic venous insufficiency (CEAP 3-6), considering~          the intravascular ultrasound (IVUS) as the gold standard for this diagnosis.~        -  Develop an algorithm for noninvasive ultrasound investigation of obstructive lesions in~          the iliac segment in patients with advanced chronic venous insufficiency (CEAP 3-6).~   "
101337|NCT02240901|"~     Perioperative airway management is a top priority of anesthesiologists in daily work, and~     endotracheal intubation (ETI) is considered as the gold standard for providing safe glottic~     seal,effective ventilation and oxygen supplement during general anesthesia. But ETI related~     complications such as concomitant hemodynamic responses, damage to the oropharyngeal~     structures at insertion and postoperative sore throat. Laryngeal mask airway(LMA) for the~     anesthesia management brings new choice with invasive, lighter cardiovascular reaction and~     many other advantages, particularly suited to short and minimally invasive surgery. But LMA~     increased the risk of gastrointestinal reflux aspiration than using ETI and it may resulted~     in intolerance in high airway pressure, especially in elderly patients with increased lung~     compliance or reduced airway resistance. Furthermore, LMA could not entirely prevent the~     occurrence of postoperative sore throat and hoarse.~      To sum up, it is necessary to carry out a multicenter clinical trial to clarify the safety of~     LMA in elderly patients. The investigators protocol will focus on the incidence of~     postoperative pulmonary complications (PPCs) when applications of LMA and ETI in elderly~     patients.~   "
101338|NCT02240888|"~     The overall objective of this project is to study the influence of modern anti-inflammatory~     treatments in established inflammatory rheumatic diseases (IRD) on immune response elicited~     by pneumococcal vaccination using 13-valent conjugate vaccine and influenza vaccination. In~     addition, the aim is to study the clinical aspects of vaccination regarding: tolerability in~     immunosuppressed patients with IRD, impact on existing rheumatic disease, possible~     association with onset of new autoimmune diseases, long-term immunity following pneumococcal~     vaccination, efficacy in preventing invasive pneumococcal diseases and influenza related~     serious infections. Results from this study are expected to bridge the existing knowledge gap~     and contribute to body of evidence needed for recommendations and implementation of~     vaccination program in IRD patients.~   "
101339|NCT02240875|"~     The purpose of this study is to assess two new Ebola vaccines: cAd3-EBO Z at 3 different~     doses, and a second vaccine, MVA-BN® Filo, at 3 different doses. The study will enable us to~     assess the safety of the vaccines and the extent of the immune response in healthy~     volunteers. The investigators will do this by giving volunteers a either one or two~     vaccinations, doing blood and saliva tests and collecting information about any symptoms that~     occur after vaccination. This is the first trial to use either of these vaccines in humans.~     We plan to recruit a total of 92 volunteers to be vaccinated.~   "
101340|NCT02240862|"~     The objective of C2R is to promote the rapid initiation and completion of enrollment in the~     CREST-2 randomized clinical trial (clinicaltrials.gov ID NCT02089217). Patients with severe~     symptomatic and asymptomatic carotid artery occlusive disease will be treated with carotid~     artery stenting (CAS) performed by experienced and skilled interventionists.~     Interventionists' eligibility will be determined by a multi-specialty Interventional~     Management Committee (IMC). Patient eligibility will include patients with standard or~     high-risk, symptomatic or asymptomatic carotid artery disease. Patients will be followed for~     the occurrence of post-procedural complications. The primary safety and quality endpoint will~     be the occurrence of any stroke or death within the 30-day period following the stenting~     procedure. The safety and quality results from C2R will guide selection of interventionists~     for participation in the CREST-2 randomized clinical trial. Enrollment into C2R will begin in~     2015 and continue until publication of the primary results of the randomized trial.~   "
101341|NCT02240849|"~     The purpose of this study is to investigate the effects of functional cervical pillow on~     inpatients with neck discomfort.~   "
101342|NCT02240836|"~     The purpose of this study, the EBBA-II trial, is to determine whether a 12 month exercise~     program comprised of strength and endurance training among newly diagnosed breast cancer~     patients undergoing adjuvant therapy, will influence factors associated metabolic profile,~     tumor growth and cardiopulmonary function. Secondary aims are to determine whether the 12~     month exercise program will influence disease-free survival, overall mortality and breast~     cancer specific mortality. Furthermore, the effect on QoL parameters, and dietary factors~     will be assessed and evaluated.~   "
101343|NCT02240823|"~     Prostate cancer is the most common cancer among Danish men, and the incidence is increasing.~     Studies have shown a high number needed to treat for each saved prostate cancer related~     death. Since the treatments incur many complications, there is a need to address these. After~     prostatectomy, 80% experience erectile dysfunction. Sexual life is a central part of people's~     identity, self-esteem and quality of life. Stem cells have generated a large amount of~     promising data suggesting that stem cells can alleviate erectile dysfunction, by regenerating~     nerves as well as endothelial and smooth muscle cells in the corpus cavernous.~   "
101344|NCT02240810|"~     To compile acute procedural performance and clinical outcomes data for the Promus PREMIER~     everolimus-eluting coronary stent system in understudied/underserved patient populations~     including women and minorities.~   "
101345|NCT02240797|"~     The purpose of this study is to use positron emission tomography (PET) imaging and magnetic~     resonance imaging (MRI) to understand the brain function of individuals with anorexia nervosa~     and healthy controls.~   "
101346|NCT02240784|"~     The purpose of this study is to characterize the natural history and clinical management of~     Acute Hepatic Porphyria (AHP) patients with recurring attacks.~   "
101347|NCT02240771|"~     In India, majority of our patients have advanced hepatocellular carcinoma (HCC) at~     presentation and hence are unsuitable for the available curative treatment options. In such~     patients the treatment options are mainly palliative. Transarterial chemoembolization (TACE),~     transarterial chemotherapy (TAC) and various forms of oral chemotherapy are the only~     available options currently. Many patients have more advanced disease with the involvement of~     branches of portal vein. This further limits the therapeutic options. According to Barcelona~     Clinic Liver Cancer (BCLC) staging, involvement of portal vein precludes any standard form of~     therapy. TAC and oral chemotherapy has been tried in this group of patients by few~     researchers. Which treatment (TAC or oral chemotherapy) would be better suitable for advanced~     stage (BCLC C) needs to be explored. However, there are no randomized controlled trials~     (RCT's) available.~      TAC is the procedure for treating patients of HCC with portal vein invasion where only the~     chemotherapeutic drugs are injected into the feeding vessels of the tumor with no subsequent~     embolization of the feeding vessels.~      In order to select a modality which would produce better outcomes in advanced HCC patients~     (BCLC C), this study was planned.~   "
101348|NCT02240758|"~     Confocal Laser Endomicroscopy (CLE) could be a useful tool for real-time diagnosis of brain~     lesions (initial diagnosis or follow-up post resection to check for residual dysplasia) and~     real-time assessment of resections margins during surgery. Probe-based CLE using the~     CELLVIZIO® has never been used for glioma surgical guided resection. Before assessing the~     potential of this technique in improving surgical resection outcome, a feasability study has~     to be performed.~   "
101349|NCT02240745|"~     The investigators are going to recruit patients who have a scheduled elective coronary~     angiography and going to do a dobutamin stress echography (DSE) before the coronary~     examination. Next to a regular 2D-DSE, the investigators will perform an 3-dimensional DSE,~     incl ventriculography. In the interventional part (coronary angiography), they will measure~     each stenosis with fractional flow-reserve (FFR)and herewith graduate its stenosis severity.~   "
101350|NCT02240732|"~     BACKGROUND In 2012 76,497 primary total knee (TKR) replacements were performed in England,~     Wales and Northern Ireland . Traditionally TKR surgery is undertaken with the aid of a~     surgical tourniquet. A surgical tourniquet is an occlusive device applied around a patient's~     leg. The tourniquet squeezes the leg (including blood vessels within the leg) and can~     therefore reduce the amount of bleeding that occurs while it is inflated. An intraoperative~     tourniquet can therefore help to improve the surgical field of view. Although the majority of~     surgeons prefer to undertake TKR surgery using a tourniquet a small but increasing number are~     now not pursuing these devices.~      There is robust evidence that the risk of deep vein thrombosis is increased if a tourniquet~     is used for TKR surgery. In addition embolic material in the venous system have been observed~     following TKR surgery and have been noted to be present in the right atrium with~     transoesophageal (TOE) echo intra-operatively. , Significant and potentially life threatening~     emboli have been documented to enter the cerebral circulation via pulmonary arterio-venous~     shunts and patent foramen ovale (PFO) (27% of patients at autopsy) , . The clinical~     manifestations of cerebral emboli post tourniquet deflation in TKR are not fully understood.~     Fat embolism syndrome and post-operative confusion in TKR patients may be the result of~     emboli formed during a TKR. ,~      AIM~        -  Is there evidence of emboli entering the cerebral circulation following tourniquet~          deflation in TKR surgery?~        -  Is there evidence of MRI detectable brain lesions and or any clinical change in~          cognition compared in patients undergoing TKR surgery with a tourniquet compared to~          those that do not have a tourniquet?~   "
101351|NCT02240719|"~     This phase I trial studies the side effects and the best dose of everolimus when given~     together with bendamustine hydrochloride in treating patients with cancer of the blood~     (hematologic cancer) that has returned after a period of improvement (relapsed) or did not~     get better with a particular treatment (refractory). Everolimus may prevent cancer cells from~     growing by blocking a protein that is needed for cell growth. Drugs used in chemotherapy,~     such as bendamustine hydrochloride, work in different ways to stop the growth of cancer~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Giving everolimus together with bendamustine hydrochloride may be a better~     treatment for hematologic cancer.~   "
101352|NCT02240706|"~     Phase I: To investigate maximum tolerated dose (MTD), safety and tolerability,~     pharmacokinetics, exploratory biomarker and efficacy of BI 836858 monotherapy in patients~     with low or intermediate-1 risk myelodysplastic syndromes (MDS) with symptomatic anemia.~     Phase II: To investigate safety and efficacy of BI 836858 plus Best Supportive Care compared~     to Best Supportive Care alone in low or intermediate-1 risk MDS patients with symptomatic~     anemia without a deletion 5q cytogenetic abnormality.~   "
101354|NCT02240680|"~     To investigate the efficacy, safety, and tolerability of linagliptin 5 milligrams once a day~     compared to placebo as as add-on therapy for 24 weeks to stable basal insulin treatment in~     elderly patients, 60 years of age and older, with Type 2 Diabetes Mellitus and insufficient~     glycaemic control.Stable background therapy of metformin and/or alpha-glucosidase inhibitors~     is also allowed.~      In addition, this trial will assess if linagliptin reduces the risk of hypoglycaemia when~     added to background basal insulin therapy. The treatment duration of this trial (24 weeks)~     will enable assessment of the clinically relevant endpoint of a decrease in glycosylated~     Haemoglobin, a well-accepted measurement of chronic glycaemic control.~   "
101355|NCT02240667|"~     1600 AF patients receiving Pradaxa or VKA for stroke prevention will be followed up for 12~     months in quarterly visits. Prescriptions, adverse events and (if applicable) reasons for~     definitive treatment discontinuation will be collected. At 6 months, patient adherence will~     be assessed, using the Morisky Score.~   "
101356|NCT02240654|"~     This is a descriptive, observational, multi-country European cross-sectional study of new~     users of dabigatran etexilate that aims to characterise on- and off-label status and other~     medical characteristics at the time of the first captured prescription of dabigatran~     etexilate in each database. The study will be conducted using Cegedim Strategic Database~     (CSD, France), Danish National Databases (Denmark) and Clinical Practice Research Datalink~     (CPRD, UK).~   "
101357|NCT02240641|"~     The study aimed at comparing the evolution of renal function in patients showing a~     hypertension treated by various therapeutic strategies.~      Due to the contract research organisation (CRO) decision in September 2000, the database was~     locked and not accessible for Boehringer Ingelheim France. Consequently it was decided to~     stop the study and not proceed to the analysis. Thus, only safety data were processed in the~     safety database.~   "
101358|NCT02240628|"~     The main objective is to evaluate if combining placing the Synera patch and using Propofol~     /Lidocaine mixture will further decrease the pain associated with the IV injection of~     Propofol.~   "
101359|NCT02240615|"~     Prospective, open label, multi-center, non-randomized study designed to collect initial~     clinical data related to the safety and clinical performance of the Sinopsys Lacrimal Stent~     for use during repair of the lacrimal system in patients with functional or obstructive~     epiphora.~   "
101360|NCT02240602|"~     Postoperative pain control is required after major abdominal surgery, including laparoscopic~     colorectal surgery. Intravenous oxycodone is widely used for postoperative acute pain control~     mainly in Europe. The aim of this study is to evaluate the optimal dose of intravenous~     oxycodone for pain control after laparoscopic colorectal surgery in Korean.~   "
101361|NCT02240589|"~     The purpose of this study is to determine if memantine can improve cognitive and~     neuropsychiatric outcomes after severe traumatic brain injury.~   "
101362|NCT02240576|"~     We would like to investigate our hypothesis of a higher prevalence of nasal fracture in the~     history of idiopathic rhinitis (IR) patients compared to healthy controls. Therefore a~     retrospective analysis of 310 patients with a nasal fracture in the past would be useful to~     investigate the incidence of IR in this cohort afterwards (5-10 y later).~   "
101363|NCT02240563|"~     INTRODUCTION: Chronic autoimmune thyroiditis (TCA) is the main cause of acquired~     hypothyroidism, which requires continuous treatment with levothyroxine (LT4). A randomized,~     placebo-controlled trial including 43 patients with hypothyroidism caused by TCA without~     nodules on ultrasonography study (US) was conducted from March 2006 to March 2009~     (NCT01129492). Among them, 23 were submitted to low-level laser therapy (LLLT) and 20 to~     placebo. The LLLT was effective in improving the echogenicity, the volume and of the thyroid~     vascularization pattern by US. There was also improvement in the thyroid function and~     reduction of serum thyroid peroxidase antibodies (TPOAb). Although the results have shown~     promising and LLLT has shown to be safe in many study models, the long-term LLLT actions on~     the thyroid parenchyma are unknown. Thus, the objective of this study is to perform~     biochemical tests and thyroid US six years after the clinical trial interventions to evaluate~     levothyroxine dose, serum levels of autoantibodies and, especially, the frequency and nature~     of nodules in the gland and then compare these variables between LLLT and placebo groups.~     METHODS: This study will include the trial participants performed six years before. The~     levothyroxine dose and serum levels of thyrotropin (TSH), T3, T4, free T4, TPOAb and~     anti-thyroglobulin antibodies (TgAb) will be evaluated in these patients. The thyroid US will~     assess the texture (with particular attention to identifying nodules), echogenicity, volume,~     as well as vascularization of the gland. The US nodules features, such as dimensions, shape,~     margins, extracapsular invasion, echogenicity, texture, hypoechoic halo, calcification,~     internal content, vascularization pattern and resistivity index will be searched. Regional~     lymph nodes and other characteristics will be also investigated. The USs will be carried out~     by only one examiner who will be blinded for the previously performed intervention (LILT or~     placebo). The same investigator will execute a fine needle aspiration (FNA) of patients with~     thyroid nodules. The cytological analysis of the material collected from the nodules will be~     undertaken by a pathologist who will be also blinded for the treatment assignments. RESULTS:~     The following variables will be compared between the two groups: levothyroxine doses,~     antithyroid antibodies, US parameters, thyroid nodules (if detected) and in this case, the~     result of their respective FNA.~   "
101364|NCT02240550|"~     This investigation will be a double-armed, randomized (Blinded patients and Blinded examiner)~     prospective study designed to collect perioperative and postoperative data to compare the QOL~     of ProFlor vs. Lichtenstein inguinal hernia repair.~   "
101365|NCT02240537|"~     The study is designed to evaluate safety, immunogenicity, and preliminary anti-tumor activity~     of a multi-peptide immunotherapy (BB-MPI-03) at three peptide+adjuvant dose levels. The~     peptides stimulate cytotoxic T-cells targeting oncofetal antigen (OFA). Subjects with AML,~     MM, sMM, or MDS who are off treatment and with stable disease or better, or who are not~     eligible for or refuse allogeneic HSCT are to be enrolled. The study will be conducted at 2~     to 4 study centers in the US.~   "
101366|NCT02240524|"~     The purpose of this study is to study the efficacy of hyperthermic intraperitoneal~     chemotherapy in the treatment of patients with locally advanced gastric cancer after radical~     gastrectomy with D2 lymphadenectomy. It is a multicentric and randomised phase III trial.~   "
101367|NCT02240511|"~     Heart Failure (HF) is a complex syndrome which can include the physiological, neural hormonal~     and metabolic complications known as Cardiac Cachexia (CC). In the development of CC there~     is a release of catabolic cytokines (Tumor Necrosis Factor-α, interleukins 1 and 6)that cause~     a decrease of fat free mass and fat mass. These changes in body composition might be reversed~     with a therapeutic combination of resistance exercise and branched chain amino acid~     supplementation (BCAA). Thus the purpose of this study is evaluate changes in body~     composition after a resistance exercise program and BCAA supplementation in patients with HF.~   "
101627|NCT02237079|"~     The goal of this pilot clinical study is to perform a randomized placebo-controlled study to~     assess the beneficial effect of a 3 month-treatment with Bazedoxifene/Conjugated Estrogens~     (BZA/CE) vs. placebo on glucose homeostasis and body composition in 20 post-menopausal women.~     The recruitment will be performed at Tulane Health Sciences Center.~   "
101368|NCT02240498|"~     The objectives of this Phase 1 study are to evaluate the safety and feasibility of~     methylene-blue-mediated photodynamic therapy (MB-PDT) performed at the time of abscess~     drainage to treat deep tissue abscesses. Safety will be evaluated by physical examination and~     imaging and laboratory studies in order to identify adverse events that may be induced by~     MB-PDT. We hypothesize that MB-PDT will be a safe and feasible intervention for this patient~     population.~   "
101369|NCT02240485|"~     The aim of the study is to compare marital treatment to individual treatment for pathological~     gambling.~   "
101370|NCT02240472|"~     Since the introduction of sentinel node biopsy in breast cancer, it has become clear that its~     use is reliable and reproducible. Today, it is clinical routine to not remove further lymph~     nodes from the axilla (arm pit) in case the sentinel node (which is the first lymph node/s~     reached by lymphatic flow from the breast) is free of tumor deposits. It is also routine to~     leave remaining lymph nodes behind in case the sentinel node contains a minimal cluster of~     tumor cells, called isolated tumor cells (formerly submicrometastasis). Even in slightly~     larger tumor deposits, so called micrometastasis (up to 2 mm in size), it has been shown that~     a completion axillary clearance (removal of further lymph nodes from the arm pit) does not~     contribute to a better survival. Data from a randomized study indicate that it seems safe to~     omit axillary clearance even if the sentinel node biopsy shows up to 2 nodes with tumor~     deposits over 2 mm in size (macrometastasis). These studies have changed clinical practice in~     many countries, however, it is still debated whether it is safe to omit axillary clearance in~     the case of sentinel node macrometastasis due to under-recruitment in the aforementioned~     study. The rationale for omitting extensive axillary surgery is the avoidance of~     postoperative morbidity such as arm lymphedema, loss of sensation, pain and swelling.~      The hypothesis is that refraining from axillary clearance in breast cancer patients with 1-2~     sentinel nodes with macrometastasis will not worsen breast cancer-specific survival by more~     than a maximum of 2.5% after 5 years.~      This study is a prospective international randomized trial including 3500 patients.~      Breast cancer patients without signs of axillary nodal involvement will be eligible for~     sentinel node biopsy. Those who are found to have up to two sentinel node containing~     macrometastasis will be informed about this trial Those wishing to participate will be~     randomized to either undergo further axillary surgery (clearance) or not. Outcome measures~     are breast cancer-specific survival, disease-free survival, axillary recurrence rate and~     overall survival.~   "
101371|NCT02240459|"~     The purpose of this study is to assess the effects of fesoterodine at 4mg and 8mg doses~     versus a placebo and oxybutynin 5mg bid versus placebo on cognitive abilities in older people~     with overactive bladder and mild cognitive impairment.~   "
101372|NCT02240446|"~     The overarching goal of this project is to expand the traditional expertise in non-invasive~     neuromodulation at the University of Minnesota towards developing novel neuromodulation~     approaches using transcranial direct current stimulation (tDCS) for treating schizophrenia~     patients with medication-resistant auditory hallucinations. The investigators will use tDCS~     to stimulate prefrontal cortex. TDCS is a non-invasive brain stimulation technique that can~     modulate brain connectivity. Non-invasive brain neuromodulation will be combined~     (paired-neuromodulation) with training of a task that requires top-down control of auditory~     processes. Paired-neuromodulation can potentially be used as a therapeutic intervention to~     decrease auditory hallucinations in schizophrenia.~   "
101373|NCT02240433|"~     The main purpose of this study is to evaluate safety and tolerability of LY2157299 when~     combined with sorafenib in Japanese hepatocellular carcinoma (HCC) participants.~   "
101374|NCT02240420|"~     The purpose of the STAR-MAMA intervention is to develop a patient-tailored telephone-base~     counseling intervention for young Latino women who are at high risk of diabetes. The~     intervention will focus at the end of pregnancy and the 9 months post-partum period to~     improve education and behavioral counseling on nutrition and other related health topics .~      The following hypotheses will be formally tested:~      Compared with controls at 9 months post-partum:~        1. Women in the STAR-Moms program will have improved self-reported behavioral outcomes for~          minutes of physical activity, lower fat diet, and breast-feeding duration (in weeks);~        2. Women in the STAR-Moms program will have improved diabetes prevention knowledge;~        3. Women in the STAR-Moms program will have increased diabetes-relevant screening rates.~      Women in the STAR-MAMA will have lost more weight than women in the control group.~   "
101375|NCT02240407|"~     A recombinant AAV vector has been generated to carry the codon-optimized acid~     alpha-glucosidase (coGAA) gene expressed from a human desmin enhancer/promoter (DES). The~     proposed clinical trial is a within-participant, double-blind, randomized, phase I controlled~     study evaluating the toxicology, biodistribution and potential activity of re-administration~     of rAAV9-DES-hGAA injected intramuscularly into the TA. Nine participants (18 to 50-years~     old) who reside within the United States with Late-Onset Pompe Disease (LOPD) will be~     included. The goal of the immune modulation strategy is to ablate B-cells (Rituximab and~     Sirolimus) prior to the initial exposure to the study agent in one leg and the subsequent~     exposure of the same vector to the contralateral leg after four months. At each study agent~     dosing, the contralateral leg will receive excipient. Patients will act as their own~     controls. Repeated measures, at baseline and during the following 3 months after each~     injection, will assess the safety, biochemical and functional impact of the vector.~   "
101376|NCT02240394|"~     Increased intracranial pressure is a cause of disease progression in patients with brain~     disease, a common cause of poor prognosis. Intracranial pressure monitoring is the~     observation of the disease, treatment, evaluation and important way to improve the prognosis.~     Non-invasive intracranial pressure monitoring can be used to stroke, intracranial hemorrhage,~     brain trauma, encephalitis and other patients. Ophthalmic artery originated from the internal~     carotid artery, the optic canal into the orbit, the entire process can be divided into~     intracranial optic tube segment and orbital segment. investigators' preliminary experiments~     show that when intracranial pressure, intracranial ophthalmic artery segment velocity~     increases with increasing velocity difference orbital segment. Accordingly, the investigators~     speculate, may be judged by the level of intracranial pressure intracranial and orbital~     velocity difference between the ophthalmic artery segment, and accordingly calculate the~     specific values of intracranial pressure. The investigators will collect brain trauma~     surgery, performed invasive intracranial pressure monitoring cases, the use of transcranial~     Doppler ultrasound velocity and different segments of the ophthalmic artery pulsatility~     index, the invasive intracranial pressure and comparing the measured values to calculate the~     the critical value of the ophthalmic artery segment intraorbital and intracranial velocity~     difference when intracranial pressure, thus fitting Based on projections of mathematical~     formulas intracranial pressure. This study will provide a non-invasive intracranial pressure~     monitor new approach.~   "
101388|NCT02240238|"~     In the dose escalation phase (Part 1), this study will determine the dose-limiting toxicities~     (DLTs), the maximum tolerated dose (MTD) and recommended Phase 2 (RPII) dose of NC 6004 in~     combination with gemcitabine.~      In the expansion phase of the study (Part 2), study will evaluate the activity, safety, and~     tolerability at the RPII dose identified in Part 1 in patients with squamous NSCLC, biliary~     tract, and bladder cancer.~   "
101377|NCT02240381|"~     This clinical trial studies the physiology and immunology of new-onset post-transplant~     diabetes mellitus in patients undergoing allogeneic stem cell transplantation. Oral glucose~     tolerance testing (OGTT), euglycemic hyperinsulinemic clamps, and immune assays will be used~     to define the mechanisms associated with abnormal glucose homeostasis following stem cell~     transplantation. Information from this clinical trial could be used to develop standardized~     screening procedures or to develop optimal treatment strategies for patients developing~     post-transplant diabetes mellitus.~   "
101378|NCT02240368|"~     The purpose of this study is to determine how Bispectral index (BIS) and Entropy EEG monitors~     agree between themselves and with end-tidal concentration of sevoflurane (ETsevo) in~     relationship with the age in the pediatric surgery setting.~      Bispectral index (BIS) and Entropy EEG monitors performance and utility is well established~     in adult general anesthesia.~      Their utility is yet undefined in the pediatric population as age seems to affect their~     ability to track the cerebral hypnotic state in children.~   "
101379|NCT02240355|"~     This multicenter, randomized, double-blind, 12-week, placebo-controlled multiple dose study~     will investigate the safety and tolerability of RO6885247 in adult and pediatric patients~     with spinal muscular atrophy (SMA).~   "
101380|NCT02240342|"~     Women delay maternity and, as a consequence, available oocyte number and their quality~     decrease (9-18% of all IVF patients). Different treatment protocols have been developed~     nevertheless none of them optimal: the number of oocytes retrieved depends on the present~     ones. New generation of oocytes and follicles has been defended by some authors and bone~     marrow seems to be involved. What seems crucial is the niche that produces paracrine signals~     able to activate dormant cells and to attract undifferentiated cells from other tissues~     (homing). This phenomenon has been described by our group in other human reproductive tissues~     like endometrium. The purpose of the study is to improve ovarian reserve in unfertile women~     with poor ovarian reserve by means of bone marrow protective capacity.~      Bone marrow progenitor cells will be delivered into the ovarian artery allowing them to~     colonize ovarian niche.~      The study hypothesis is that bone marrow progenitor cells will improve ovarian reserve~     differentiating themselves into germ cells or, more likely, stimulating the niche to activate~     dormant follicles.~   "
101381|NCT02240329|"~     The purpose of this research study is to evaluate coughing in people who have had a brain~     injury. It is hypothesized that individuals who have sustained a brain injury will~     demonstrate differences in cough waveform and respiratory measures compared to individuals~     who have not sustained a brain injury.~   "
101382|NCT02240316|"~     This observational study aims to assess the therapeutic responsiveness of MabThera SC in~     patients with malignant lymphomas under everyday clinical practice conditions. Patients with~     previously untreated CD-20 positive follicular non-Hodgkin's lymphoma (NHL) or previously~     untreated CD-20 positive diffuse large B-cell lymphoma (DLBCL) who are planned for therapy~     with MabThera SC according to the assessment of the physician will be prospectively enrolled~     for observation. No study specific measures are required; treatment and documentation will be~     performed according to usual clinical practice.~   "
101383|NCT02240303|"~     The aim of this project will be to document the central and peripheral mechanisms, which may~     predict clinical pain characteristics and associated physical performance in older adults.~     Although chronic pain is common among older adults, there is limited understanding on the~     processing of pain and the mechanisms by which it affects physical function in these~     individuals. The first aim of this study will be to examine predictors of clinical pain in~     older adults. These will include a comprehensive somatosensory assessment battery including~     mechanical and thermal detection and pain thresholds in older adults with and without chronic~     pain. The investigators will also assess basal cognitive and physical function to determine~     their associations with chronic pain. Finally, brain structure and function will be assessed~     in these older adults with and without pain.~   "
101384|NCT02240290|"~     The purpose of the study is to investigate how tozadenant is absorbed, distributed, broken~     down and eliminated from the body. The compound to be administered will be radiolabeled. This~     enables the investigator to trace the compound in blood, urine, feces, expired air and track~     what happens to it.~   "
101385|NCT02240277|"~     Patients with septic shock may have altered volume of distribution and metabolism of~     antibiotics which are crucial medications for treating infections. The aim of the study is to~     investigate the blood concentrations of Meropenem and Ciprofloxacin, two commonly used~     antibiotics, in patients with septic shock. The hypothesis is that standard dosing may~     produce insufficient levels of antibiotics in patients with septic shock.~   "
101386|NCT02240264|"~     The brain is primarily developed in the third trimester of pregnancy, but continues maturing~     through the late twenties, especially the prefrontal cortex. Omega-3 long-chain~     polyunsaturated fatty acids (LCPUFA) are important structural components of neural cell~     membranes, influence membrane fluidity and signal transduction, and thus learning, cognition~     and behaviour. Levels of omega-3 LCPUFA have been found to be low in individuals with~     limitations in these complex brain functions. Previous studies suggested that such functions~     could be improved by increasing LCPUFA. The adolescent brain, however, has been largely~     neglected. This study investigates the effect of one-year daily omega-3 LCPUFA~     supplementation, in particular krill oil, in healthy 14-15 year old adolescents in lower~     general secondary education (MAVO/VMBO) on learning, cognition, and behaviour. The majority~     of the omega-3 PUFA in krill oil is incorporated into phospholipids, favouring tissue uptake~     of its omega-3 PUFA. In a double blind, randomised controlled trial, 300 adolescents~     preselected from a population of 700 adolescents with low omega-3 index (<5%) will receive~     daily omega-3 LCPUFA supplementation or matching placebo. The omega-3 LCPUFA dose will be~     adjusted individually to reach a target level of 8-11%. The effects on learning (academic~     achievement, objective cognitive performance), behaviour (mood, self-esteem, motivation,~     goal-orientation, absenteeism), and in a subsample cognitive processes, in particular~     perceptual processes measured by eye-tracking will be evaluated after 6, 12, and 24 months.~     This study will yield important insights in the effects of omega-3 LCPUFA supplementation, a~     safe intervention, on a large variety of complex brain functions.~   "
101387|NCT02240251|"~     This is a prospective chart review to follow our laser-assisted IVC filter retrieval~     patients. We intend to validate existing literature and scientific findings by publishing our~     own clinical experience in difficult IVC filter retrievals.~   "
101390|NCT02240212|"~     This is a Phase Ib, open-label, dose-escalation study to determine the Maximal tolerated dose~     (MTD) and the recommended Phase 2 dose (RP2D) for the combination of afuresertib and~     paclitaxel in subjects with recurrent HER2-negative gastric cancer, and further assess safety~     and preliminary efficacy of combination at the RP2D. Afuresertib had showed synergistic~     activity when combined with paclitaxel in vitro and in vivo models of gastric cancer. Dose~     escalation will continue until the MTD is established. The dose schedule is once daily (QD)~     dosing for afuresertib and intravenous (IV) infusion for paclitaxel Dose escalation in Part 1~     will follow the 3 + 3 cohort design. A sequential approach will be conducted to explore the~     optimal paclitaxel regimen (weekly or 3weekly schedule) when combined with afuresertib. The~     dose escalation will be started from Cohort A (afuresertib combined with weekly paclitaxel~     regimen at 80 milligram (mg)/meter (m)^2 day1, 8,15, every 4 weeks (q4w). The starting dose~     in Cohort A will be 125 mg afuresertib QD. Once its MTD is identified, and then the study~     will move to dosing Cohort B (afuresertib combined with 3 weekly paclitaxel regimen at 175~     mg/m^2 day1, every 3 week (q3w). The starting daily dose of Cohort B will be 25 mg less than~     the MTD dose from Cohort A for afuresertib. If it is tolerated, then the dose escalation~     schedule will be followed in Cohort B until the MTD in this Cohort is reached. If the~     starting dose is not tolerated, then dose de-escalation will be explored until the MTD in~     this Cohort is reached. Once two dimensions of the MTD are achieved, then the optimal regimen~     for paclitaxel and MTD for afuresertib combined with paclitaxel based on the toxicity profile~     will be identified. The combination regimen at the RP2D selected following Part I will be~     further investigated in its efficacy and safety in the Part II Expansion Cohort. Once a~     combination dose regimen for Part 2 has been determined, at least 20 and up to 40 subjects~     will be enrolled at the dose regimen selected following Part I. Overall response rate (ORR)~     will be evaluated using a Green-Dahlberg design. The design consists with one interim~     analysis. If less than 3 responses are observed in the initial 20 subjects, enrollment will~     be terminated due to futility; otherwise, the study will continue to meet the planned sample~     size of 40 subjects.~   "
101391|NCT02240199|"~     Breast tissue and the areas surrounding the breast contain many small to medium-sized nerves.~     During surgery on the breast, these nerves can be inadvertently cut or damaged. Chemotherapy~     and radiotherapy after surgery worsen the injury experienced by these nerves. These nerves~     eventually become abnormal and provide pain signals to the brain well beyond the healing~     period after surgery. Patients with these abnormal nerves suffer from chronic pain in the~     breast area that persists for several years after surgery. Chronic pain is associated with a~     reduced quality of life, daily functioning, psychological distress, and contributes to~     excessive health care expenditures. There is encouraging data suggesting that an infusion of~     Lidocaine during surgery and Pregabalin given around the time of surgery can prevent the~     development of chronic pain after breast cancer surgery. A large randomized controlled trial~     is needed to determine the efficacy of these two interventions on reducing chronic pain after~     breast cancer surgery (e.g. within 3 months of surgery). A pilot trial is first needed to~     determine the feasibility of undertaking such a trial.~   "
101392|NCT02240186|"~     This study will assess if the functional performance and musculoskeletal outcome of~     transfemoral amputees are improved after receiving a Microprocessor Knee (MPK) compared to a~     Non-Microprocessor Knees (NMPK).~   "
101393|NCT02240173|"~     Sorghum bicolor is a naturally growing plant which has been of health benefit to the people~     of West Africa who traditionally prepare its leaf for various nutritional and health~     reasons.The food and nutritional fact analysis showed that Jobelyn is rich in Carbohydrates,~     Protein, Dietary Fiber, Iron, Natural Vitamins like B12 and Vitamin C. It also contains~     Selenium, Omega 3,6 and 9 and other essential elements and fatty acids. Although the~     determinants of mental health are complex, the emerging and compelling evidence for nutrition~     as a crucial factor in the high prevalence and incidence of mental disorders suggests that~     diet is as important to psychiatry as it is to cardiology, endocrinology, and~     gastroenterology. Evidence is steadily growing for the relation between dietary quality (and~     potential nutritional deficiencies) and mental health, and for the select use of~     nutrient-based supplements to address deficiencies, or as monotherapies or augmentation~     therapies. There is currently strong advocacy for the recognition of diet and nutrition as~     central determinants of both physical and mental health.Its anti-inflammatory and haematocrit~     boosting properties have been well documented though the precise mechanism of action is still~     largely unknown. Its use has recently been extended to the field of mental health where~     findings in animal study suggest it could be of help in relieve of psychosis. The need for~     this study is therefore aimed at investigating the effect of this drug in patients with~     schizophrenia which is the prototypical psychotic disorder.~   "
101394|NCT02240160|"~     To evaluate the effect of oral pH on the pharmacokinetics (PK) of a single oromucosal dose of~     Sativex (four sprays containing 10.8 mg Δ9 tetrahydrocannabinol (THC) and 10 mg cannabidiol~     (CBD)) by comparing the PK profile of Sativex in healthy subjects.~      The primary clinical hypothesis is that there will be an effect of oral pH on the PK of~     Sativex when administered as a single oromucosal dose (four sprays).~   "
101395|NCT02240147|"~     Almost 1% of all baby's is born with a heart defect (CHD) and most of them survive. Even~     though outcomes are good, they need lifelong follow-up because of a higher risk for~     cardiovascular diseases. Studies have shown that patients with CHD are not active enough and~     that a substantial amount of patients is overweight. Hence preventive strategies and~     education should not only focus on the heart problem, but also on a healthy lifestyle~     including physical activity. Recently a new guideline introduced exercise prescription based~     on the absence/presence of certain key elements. However, a number of important questions~     remain that preclude implementation in clinical practice. Therefore a 'Start-to-Sport'~     program for adults with CHD, based on this new guideline, will be investigated. This study is~     a randomized controlled trial that investigates the effects of the program on daily physical~     activity, exercise capacity, quality of life and exercise self-efficacy both in short (12~     weeks) and long (52 weeks) term, along with possible mechanisms for the training effects by~     using a new exercise-testing protocol that looks simultaneously to all body parts that are~     involved during exercise. Ultimately, our findings will result in the implementation of the~     guideline in clinical practice.~   "
101402|NCT02240056|"~     Certain cardiac and neurologic diseases influence each other via a still poorly understood~     brain-heart axis. Subarachnoidal bleedings are well known to cause ECG alterations~     resembling those of myocardial infarction, along with a reduction of systolic myocardial~     function (neurogenic stunned myocardium). Alterations of the right insula region by a~     stroke or intracranial hemorrhage go along with a sympathetic activation (increased~     circulating catecholamine levels, tachycardia, arterial hypertension). In contrast,~     alterations of the left insula region often cause vagal reactions such as bradycardia,~     arterial hypotension. Takotsubo cardiomyopathy (TTC) is a just recently recognised subform of~     heart attacks, often caused by psychological or physical stress (death of a beloved one,~     divorce, job loss, infection, preoperative state). In more than 90% of cases, TTC affects~     postmenopausal women.~      Functional MRT enables imaging of activated brain regions, either without (resting state)~     or with specific stimuli. The investigators speculate that there is a specific involvement of~     the insula region during TTC.~   "
101396|NCT02240134|"~     Acute lower respiratory tract infections (LRTIs) account for more than 27% of all~     hospitalizations among US children under five years of age, with recurrent LRTIs in children~     a recognized risk factor for asthma. Residential biomass combustion leads to elevated indoor~     levels of fine particulate matter (PM2.5) that often exceed current health-based air quality~     standards. PM2.5 exposure is associated with many adverse health outcomes, including a~     greater than three-fold increased risk of LRTIs. To date, exposure reduction strategies in~     wood stove homes have been either inconsistently effective or include factors that limit~     widespread dissemination and continued compliance in rural and economically disadvantaged~     populations. In this project, the investigators propose to test the efficacy of two~     intervention strategies for reducing indoor wood smoke PM2.5 exposures and children's risk of~     LRTI in three unique and underserved settings: (1) rural mountain valley communities in~     western Montana; (2) Navajo Nation communities; and (3) Alaska Native Villages. The~     investigators will conduct a three-arm randomized placebo-controlled post-only intervention~     trial in wood stove homes with children less than five years old. Education on best-burn~     practices and training on the use of simple instruments (i.e., stove thermometers and wood~     moisture meters) will be introduced as one intervention arm (Tx1). This intervention will be~     evaluated against an indoor air filtration unit arm (Tx2), as well as a placebo arm (Tx3,~     sham air filters). The primary outcome will be LRTI incidence among children under five years~     of age. To allow for detection of exposure and outcome differences within each of the three~     regions, a sample of 324 homes, or 108 within each study area will be equally assigned to~     each of the three intervention arms. The overall hypothesis is that a low-cost, educational~     intervention targeting indoor wood smoke PM2.5 exposures will be sustainable, and can reduce~     children's risk of LRTI in underserved Native and rural communities.~   "
101397|NCT02240121|"~     The primary objective is to determine the efficacy of rifaximin DR tablets vs. placebo for~     the induction of clinical remission and endoscopic response following 16 weeks of treatment~     in subjects presenting with active moderate Crohn's disease. A key secondary objective is to~     evaluate clinical and endoscopic remission following an additional 36 weeks of treatment.~   "
101398|NCT02240108|"~     The primary objective is to determine the efficacy of rifaximin DR tablets vs. placebo for~     the induction of clinical remission and endoscopic response following 16 weeks of treatment~     in subjects presenting with active moderate Crohn's disease. A key secondary objective is to~     evaluate clinical and endoscopic remission following an additional 36 weeks of treatment.~   "
101399|NCT02240095|"~     Translation of new knowledge from research into evidence-informed health care is a shared~     obligation of the clinical and the scientific communities. Unfortunately, studies of quality~     of care continue to show that this goal is substantially unrealized. One main barrier is lack~     of quick and easy identification, appraisal and synthesis of current best evidence. This~     start with medical and nursing students, which have numerous clinical-related questions~     daily, but face a large volume of 3000 articles published every day, accessible in many~     scattered resources.~      To address theses problems, McMaster's Health Information Research Unit (Hamilton, Ontario,~     Canada) has developed and implemented McMaster Premium LiteratUre Service Federated Search~     (MPFS), an online search engine that provides a unique 1-stop search and organized access to~     current best evidence in daily practice. However additional barriers need to be overcome for~     students to actually search and use this evidence in their learning and practice. Theses~     include logistical barriers (time constraints, forgotten questions), as well as educational~     barriers (eg, lack of awareness of the architecture of evidence, limited searching skills,~     and lack of reference standards among peers for finding best evidence).~      In a previous trial, the investigators tested 3 innovative online interventions among~     clinicians registered to MPFS to overcome these barriers and increase the quantity and~     quality of searching for current best evidence to answer clinical questions (NCT02038439).~     The investigators seek to conduct a second randomized trial testing the same 3 interventions,~     this time among medical and nursing students registered in MPFS.~   "
101400|NCT02240082|"~     This study is a clinical trial in which 300 Police Officers who currently work midnight~     shifts in the participating police departments will be recruited to test the effectiveness of~     a new web-based program to address sleep and associated problems related to shift work,~     particularly night shift work. Recruitment letters will be sent to all officers currently~     working midnight shift, with the goal of recruiting 300 officers willing to participate in~     the study. The 300 participants will be randomly assigned to either the experimental group~     (receiving the web-based program) or the waitlist control group. Participants in the~     experimental group will be given access to the program site (COPing with Shift Work) and the~     mobile application (Sleep Tracker). Following completion of the field test, participants in~     the control condition (as well as all other interested officers) will have access to the~     web-based COPing with Shift Work program.~      All participants will be asked to complete a baseline questionnaire containing multiple~     measures of sleep, dietary practices, physical activity and job performance. Participants~     will be asked to complete the posttest approximately three months following initial access to~     the intervention.~      Primary and secondary outcome measures: The Primary outcome measures are sleep quality as~     measured by the Pittsburgh Sleep Quality Index (PSQI) and sleepiness as measured by the~     sleepiness subscale of the widely used Karolinska Sleep Questionnaire (KSQ). The~     investigators have adapted the sleep measures to apply to individuals who work nights and may~     sleep during the day.~      Secondary outcome measures include the Nutritional Patterns Scale, a 13-item modification of~     the Block Self-Administered Diet History Questionnaire assessing the nutritional value of the~     respondent's diet; Attitudes Toward a Healthy Diet, a 17-item scale, based on the Health~     Belief Model and developed and validated by Trenkner and associates assessing perceived~     benefits and barriers to eating a healthy diet; the Godin Leisure-Time Exercise~     Questionnaire, a brief 4-item query of usual leisure-time exercise habits; and work~     productivity measured with the Work Limitations Questionnaire (WLQ), developed and validated~     by Lerner and associates.~      It is expected that the program group participants will have significantly better outcomes~     than the control group at three months.~   "
101401|NCT02240069|"~     A critical need exists for efficient community-based interventions aimed at reduction of~     environmental exposures relevant to health. Biomass smoke exposures due to residential wood~     heating are common among rural Native American communities, and such exposures have been~     associated with respiratory disease in susceptible populations. In many of these communities~     wood stoves are the most economic and traditionally preferred method of residential heating,~     but resource scarcity can result in burning of improper wood fuels and corresponding high~     levels of indoor particulate matter. Community-based participatory research techniques will~     be used to adapt intervention approaches to meet the cultural context of each participating~     community. At the community level, investigators will facilitate local development of a~     tribal agency-led wood bank program ensuring that elderly and/or persons with need have~     access to dry wood for heating. At the household level, investigators will use a three arm~     randomized placebo-controlled intervention trial to implement and assess education/outreach~     on best burn practices (Tx1). The content and delivery strategies of the education~     intervention will be adapted to each community according to stakeholder input. This~     educational intervention will be evaluated against an indoor air filtration unit arm (Tx2),~     as well as a placebo arm (Tx3, sham air filters). Tx3 will be used in comparison with the~     other two treatment arms to evaluate the penetration and efficacy of the community-level wood~     bank program. Outcomes will be evaluated with respect to changes in pulmonary function~     measures and respiratory symptoms and conditions among household elders. The investigators~     hypothesize that locally-designed education-based interventions at the community and~     household levels will result in efficacious and sustainable strategies for reducing personal~     exposures to indoor particulate matter, and lead to respiratory health improvements in~     elderly Native populations. This study will advance knowledge of cost-effective environmental~     interventions within two unique Native American communities, and inform sustainable~     multi-level strategies in similar communities throughout the US to improve respiratory health~     among at-risk populations.~   "
101403|NCT02240043|"~     The aim of this study is to evaluate the growth hormone (GH) and adrenocorticotrophic hormone~     (ACTH) secretion in elderly without hypothalamic-pituitary disease using the glucagon~     stimulation test (using Glucagen® Hypokit, Novo Nordisk A/S, Denmark) and evaluate some~     parameters such as sarcopenia, nutritional state, bone mineral density, frailty criteria with~     secretion of GH.~   "
101404|NCT02240030|"~     This randomized, multicenter, placebo-controlled, double-blind study will evaluate the~     efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing~     motor response fluctuations (OFF phenomena) as an outpatient (i.e., at home) and in the~     clinic.~      Patients who successfully complete this study will be eligible to enroll into a 12 month~     treatment extension (CVT-301-004E) study.~   "
101405|NCT02240017|"~     This is a phase II/III, multicenter, randomized study which includes 420 patients on six~     years + 3 years follow up. 92 patients will be included during the phase II ; additional 328~     patients will be included.~      Patients with an advanced or metastatic urothelial cancer with impaired renal function will~     be randomized in one of the two following chemotherapy arm:~        -  Fractionated Cisplatin + Gemcitabine.~        -  Carboplatin + Gemcitabine.~      The main objective of the part II study will be to evaluate the efficacy and the safety of a~     chemotherapy with a doublet platinum salt compound/Gemcitabine with fractionated Cisplatin or~     Carboplatin in this population.~      The main objective of the part III study will be to compare the efficacy in terms of overall~     survival of a chemotherapy with a doublet platinum salt/Gemcitabine with fractionated~     Cisplatin or Carboplatin in this population.~   "
101406|NCT02240004|"~     The aim of this study is to compare purification efficiency of HFR in terms of clearance of~     protein-bound toxins and the effects on markers of inflammation and endothelial damage, in~     comparison to HF-HD and OL-HDF.~   "
101407|NCT02239991|"~     A point-of-care bleeding management protocol based on global viscoelastic test~     (thromboelastometry) can change the amount of blood products used during orthotopic liver~     transplant.~   "
101408|NCT02239978|"~     The primary goal of this project is to gain a better understanding of whether and how~     levodopa (a common anti-Parkinson disease medication) alters postural motor learning in~     people with Parkinson disease. A secondary goal is to assess whether motor cortical~     excitability, measured via Transcranial magnetic stimulation, is related to postural motor~     learning.~      Participants with Parkinson disease will complete between 50 and 100 postural perturbations~     (via support surface translations), ON and OFF their dopamine replacement therapy (i.e.~     levodopa). Adaptation of responses to these perturbations will be tracked. Participants will~     also undergo transcranial magnetic stimulation to capture cortical excitability of the brain~     (in particular the motor cortex). Cortical excitability will be correlated to adaptation of~     stepping (i.e. postural motor learning) ON and OFF levodopa. Investigators will also capture~     postural motor learning and cortical excitability in age-matched healthy adults.~      Investigators hypothesize that dopamine will have a negative effect on postural motor~     learning, and the cortical excitability will be correlated to postural motor learning.~   "
101409|NCT02239965|"~     Monitoring the degree of neuromuscular blockade in general anaesthesia reduces complications~     and patient discomfort. However, monitoring is not applied consistently by Danish anaesthesia~     personnel. Surveys show that part of the explanation is that the anaesthetists often~     experience problems with the equipment used for monitoring, though the problems have not been~     described in detail.~      We hypothesise that the lack of consistent monitoring in general anaesthesia is caused by~     insecurity in the anaesthesia personnel's set-up and use of the equipment, as well as in~     interpreting the measurement results.~   "
101410|NCT02239952|"~     The purpose of this study is to determine intratumoral concentration of kinase inhibitors~     upon 2 weeks of treatment in tumor tissue (in the brain) of patients with high-grade gliomas~     (HGG).~   "
101411|NCT02239939|"~     The purpose of this research study is to see whether wearing a weighted vest during a period~     of active weight loss can decrease the loss of muscle and bone that occurs during weight~     loss. We will also determine if study participants who wear the weighted vest will have~     greater improvements in physical function and self-reported disability, pain, stiffness,~     fatigue and quality of life. This knowledge could impact weight loss programs designed for~     older adults.~      Hypothesis: Participants randomized to VEST will experience similar weight loss, but less~     loss of lean mass and bone density, than participants randomized to Control.~   "
101412|NCT02239926|"~     Will Ranolazine improve bowel function and abdominal pain in human subjects with IBS-D?~   "
101413|NCT02239913|"~     This study will determine the influence of topiramate (Topamax®) and phentermine (Adipex®),~     alone and in combination, on the reinforcing, subjective and physiological effects of~     cocaine.~   "
101414|NCT02239900|"~     The goal of this clinical research study is to find the highest tolerable dose of ipilimumab~     and stereotactic body radiation therapy (SBRT). The safety and effectiveness of these~     treatments given consecutively will also be studied.~      This is an investigational study. SBRT is FDA approved for the control of metastatic and~     primary tumors. Ipilimumab is FDA approved and commercially available for the treatment of~     metastatic melanoma that cannot be removed with surgery. The use of SBRT with ipilimumab is~     investigational. The study doctor can explain how the study drug is designed to work.~      Up to 120 participants will be enrolled in this study. All will take part at MD Anderson.~   "
101415|NCT02239887|"~     Purpose To establish the safety and efficacy of the Coherex WaveCrest Left Atrial Appendage~     Occlusion System for left atrial appendage (LAA) closure during treatment of non-valvular~     atrial fibrillation in patients who are at increased risk for embolic stroke and have an~     ongoing indication for oral anticoagulation.~   "
101416|NCT02239874|"~     The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial~     in 25,875 U.S. men and women investigating whether taking daily dietary supplements of~     vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of~     developing cancer, heart disease, and stroke in people who do not have a prior history of~     these illnesses. This ancillary study is being conducted among participants in VITAL and will~     examine whether vitamin D effects mammographic breast density, mammographic texture features,~     and gene expression profiles in breast biopsy tissue.~   "
101432|NCT02239653|"~     Objective: to test the hypothesis that an intervention comprised of targeted physician and~     print messages can influence parents to reduce the amount of sugar-sweetened beverages (SSB)~     and fruit juice they give to their children 1 - 12 years of age.~   "
101433|NCT02239640|"~     The purpose of this registry is to assess clinical outcomes, and different factors that may~     affect these clinical outcomes such as systems of care, associated with the use of Covidien~     market-released neurothrombectomy devices intended to restore blood flow in patients~     experiencing acute ischemic stroke due to large intracranial vessel occlusion.~   "
101417|NCT02239861|"~     This is a clinical trial for patients with a solid tumor which has come back, or may come~     back, or has not gone away after treatment, including the standard treatment we know for~     these diseases. This is a study using special immune system cells called tumor-associated~     antigen (TAA)-specific cytotoxic T lymphocytes, a new experimental therapy.~      The proteins that the investigators are targeting in this study are called tumor-associated~     antigens (TAAs). These are cell proteins that are specific to the cancer cell, so they either~     do not show or show up in low quantities on normal human cells. In this study, the~     investigators target five common TAAs called NY-ESO-1, MAGEA4, PRAME, Survivin and SSX. On a~     different study, patients have been treated and so far this treatment has shown to be safe.~      The investigators now want to try this treatment in patients with solid tumors.~      This protocol is designed as a Phase I dose-escalation study.~   "
101418|NCT02239835|"~     Objectives of the study were to evaluate the efficacy and safety of two different doses of~     tipranavir (TPV) in combination with ritonavir (TPV/r) compared with a standard dual PI~     combination of saquinavir (SQV) and ritonavir (RTV) and to evaluate the dose response of two~     different doses of TPV in combination with RTV for efficacy and safety.~   "
101419|NCT02239822|"~     Double Blinded Randomized Trial of eTNS as adjuvant treatment for Major Unipolar Depressive~     Disorder. The primary objective is to assess the safety and tolerability of eTNS (external~     trigeminal nerve stimulation) of the V1 branch of the trigeminal nerve as an adjunctive~     treatment for adult patients with the diagnosis of unipolar MDD (Major Depressive Disorder).~   "
101420|NCT02239809|"~     Double Blinded Randomized Trial of sTNS as adjuvant treatment for Major Unipolar Depressive~     Disorder. The primary objective is to assess the safety and tolerability of an implantable~     sTNS of the V1 branch of the trigeminal nerve as an adjunctive treatment for adult patients~     with the diagnosis of unipolar MDD (Major Depressive Disorder).~   "
101421|NCT02239796|"~     To aim of this study is to establish the feasibility of undertaking a phase III trial of~     transcutaneous posterior tibial nerve electrical stimulation (TPTNS) to alleviate~     stroke-related urinary incontinence.~   "
101422|NCT02239783|"~     Sponsor is conducting this post market clinical follow-up (PMCF) study to evaluate the safety~     and efficacy of its total hip arthroplasty (THA) marketed in the European Union (EU) . These~     types of studies are required by regulatory authorities for all THA devices that do not have~     clinical evidence available at the time of gaining approval to market in the EU. This study~     has been designed in accordance with MEDDEV 2.12/2 rev 2.~   "
101423|NCT02239770|"~     The objective of this study is to test the effect of a range of doses of a novel nicotine~     film on plasma nicotine levels, expired carbon monoxide and, via a questionnaire, subjective~     ratings of the film and side effects. The nicotine film is not part of standard of care and~     is not available in a non-investigational setting. The investigators hypothesize that plasma~     nicotine levels will be in keeping with those induced by other oral nicotine replacement~     therapies (NRTs) and by the smoking of a cigarette. Thus, the investigators predict that~     random delivery of nicotine via the oral film will be safe and well-tolerated by the human~     subjects.~   "
101424|NCT02239757|"~     Outcomes of patients with acute ST-elevation myocardial infarction (STEMI) are directly~     related to reperfusion time. Effect of transradial approach (left vs right) on reperfusion~     time has not been fully studied for SETMI patients undergoing primary percutaneous coronary~     intervention (PCI). The aim of this study was to randomly investigate the efficacy and safety~     of left radial approach for primary PCI in STEMI patients compared with right radial~     approach.~   "
101425|NCT02239744|"~     This study aimed to evaluate whether a short-term indoor air purifier intervention improves~     cardiopulmonary health based on a randomized double-blind crossover trial~   "
101426|NCT02239731|"~     The purpose of this study is to evaluate the safety, tolerability and efficacy of FDX104~     Antibiotic Foam in the prevention of EGFRI skin toxicity in cancer patients receiving~     Cetuximab or Panitumumab.~   "
101427|NCT02239718|"~     Tooth replacement is a significant issue in the World and while dental implants and~     conventional bridges have been used to replace missing teeth, dental implants are too~     expensive for many and conventional dental bridges are destructive to supporting tooth~     tissue.~      Resin-bonded bridges (RBBs) are a conservative and cost effective replacement option that~     involves minimal tooth preparation, leaving the majority of the tooth intact. They are~     secured in place with an adhesive cement, which is bonded to the outer enamel layer. Clinical~     audit of these prostheses at the University of Hong Kong shows two-unit RBBs to have some of~     the highest success rates in the dental literature for the replacement of missing premolar~     and incisor teeth. However, for the replacement of molar teeth, two-unit RBBs are not~     performed, as established protocol and recognised texts contraindicate their use due to~     concerns with tipping or drifting of supporting teeth. Replacement of a single missing molar~     tooth can be with a three-unit, fixed-fixed (single-piece casting) or three-unit,~     fixed-movable (two-part casting). However, the fixed-fixed option has a higher debond failure~     rate than two-unit RBBs and therefore, at this centre, a modified, 3-unit fixed-movable~     design is used. This two-part casting allows for minor, independent movements of the~     supporting teeth and thereby aims to reduce stresses between them and, similarly, reduce~     de-bonding forces. This has the potential for greater longevity and easier long-term~     maintenance as if the major part of the bridge debonds it can be recemented.~      The aim of this unique study is to compare 2-unit and 3-unit RBBs for the replacement of~     single missing molar tooth in a randomized clinical trial. These two designs will be~     clinically evaluated at 6 months , 1 year, 2 years and 3 years to observe the outcome~     measures. The primary outcome will examine the success of the dental prostheses with respects~     to the need of any clinical intervention to repair or remediate the RBB or supporting tooth.~     Minor outcome measures will examine fatigue or damage to the prosthesis, changes in bone~     support, pulpal or periodontal health or tooth mobility. Patient satisfaction and quality of~     life evaluation of the dental prostheses will also be examined. Will 2-unit RBBs offer~     patients a simpler, cheaper, and successful option over current designs? This has not been~     previously reported.~   "
101428|NCT02239705|"~     The purpose of this study is to investigate whether cardiac output (CO) and global end~     diastolic volume (GEDV) determined from the same thermodilution curve by EV1000 are~     mathematically coupled during the infusion of fluid or inotropic agents in critically ill~     patients.~   "
101429|NCT02239692|"~     This was a phase 3, randomised, assessor‑blinded, multi‑centre trial comparing the efficacy,~     safety and tolerability of a PICOPREP tailored dosing schedule to the PICOPREP day‑before~     dosing schedule for colon cleansing in preparation for colonoscopy.~   "
101430|NCT02239679|"~     The purpose of this study is to determine if Levulan photodynamic therapy (PDT) is safe and~     effective in the treatment of actinic keratoses (AK) on the face, following treatment with~     liquid nitrogen cryotherapy.~   "
101431|NCT02239666|"~     To estimate the real-world effectiveness of approved biologics in subjects with~     moderate-to-severe plaque psoriasis who are either starting or switching biologic medication.~   "
106539|NCT02172885|"~     The purpose of this study is to determine the safety and effectiveness of five infusions of~     characterized HLA-identical MSC in non immunosuppressed children with Osteogenesis Imperfecta~     (OI).~   "
101434|NCT02239627|"~     Low back pain is a common condition, affecting majority of the adults in the United States at~     some point in their lives. Fortunately, most resolve, even without treatment. However, some~     suffer from continued or recurrent pain.~      For those suffering from continued or recurrent low back pain, numerous treatment options~     exist. One such option is an epidural injection, particularly when other non-surgical~     treatment options have failed. An epidural injection is the placement of a needle into the~     space around the spinal cord with the aid of a live X-Ray machine, followed by an injection~     of various medications. Typically, the medication that is injected is a steroid, commonly~     with the combination of local anesthetic medication. Epidural steroid injections, with or~     without local anesthetic is part of the established standard of care in the United States for~     those with continued or recurrent low back pain. The steroid is believed to reduce~     inflammation and edema of the injured or irritated nerves. However, despite the routine use~     of epidural steroids, the steroid itself is not without risks or side effects. Though rare,~     the steroids have been associated with complications including osteoporosis, steroid induced~     myopathy, cataracts and many others. In order to minimize the side effects associated with~     epidural steroids, limiting the dose and frequency have been outlined.~      Clonidine is another medication, commonly used in numerous clinical settings. U. S. Food and~     Drug Administration approved the medication for epidural use for cancer pain but studies have~     shown effectiveness in non-cancer pain was well and is routinely used for various conditions.~     There is growing evidence on the use of epidural clonidine for treatment of pain, including~     low back pain.~      This research will study and compare the effectiveness, if any, of clonidine compared to~     steroid in an epidural injection for low back pain.~   "
101435|NCT02239614|"~     The potential synergistic effect of administering 2 dengue vaccine candidates that were~     previously shown to be safe and immunogenic in humans will be evaluated in this study. A~     prime-boost study of tetravalent dengue virus purified inactivated vaccine (TDENV-PIV) with~     alum and tetravalent dengue live attenuated virus (TDENV-LAV) vaccine Formulation 17 (F17)~     will gather data to help better understand the human immune response to dengue vaccination~     and infection.~   "
101436|NCT02239601|"~     The cause of Chemotherapy-Induced Peripheral Neuropathy (CIPN) is still unknown. A theory is~     that the microtubule-stabilizing agents that prevent division of cells also affect healthy~     peripheral nerves. Symptoms of CIPN are in the hands/feet and include: pain, numbness, and~     loss of function. An estimated 55-60% of patients will experience lasting symptoms affecting~     function for years post-treatment. Research on nerve disorders identifies that a nerve~     already entrapped/damaged at one site may be at greater risk when combined with chemotherapy~     (double crush syndrome). Physical therapy is an established, effective treatment for~     entrapped nerves and neuropathic pain. This study seeks to identify additional risk factors~     and provide evidence for the role of physical therapy in the treatment of CIPN.~      Hypotheses~        1. Physical therapy will assist in managing symptoms (sensory, pain, edema) compared to the~          control group during chemotherapy.~        2. Positive tests for mechanical entrapment prior to chemotherapy will result in more~          severe symptoms of CIPN.~        3. The treatment group will have greater resolution of CIPN symptoms compared to control at~          the six month follow-up.~   "
101437|NCT02239588|"~     This was a randomized, double-blind, single-center, placebo-controlled, three-arm study, with~     a 12-week intervention period.~      The objectives of this study were to evaluate the effect of Pure Canterbury Stage 1 (0-6~     months) milk powder on:~        1. Bone health;~        2. Infants growth;~        3. Intestinal health;~        4. Gastrointestinal tolerance to the test product;~      g) Incidence of Eczema~   "
101438|NCT02239575|"~     This study will enroll specimens from subjects diagnosed with various cancers and who have~     either:~        1. RETROSPEFCTIVE / ARCHIVAL SAMPLES already undergone surgical resection of their tumor~          and have one or more formalin fixed and paraffin embedded (FFPE) blocks on file within~          the local (or affiliated) pathology archive (replicate blocks from same tumor) or blocks~          no longer required to be maintained on file - discard blocks, or~        2. PROSPECTIVE SAMPLES are scheduled to undergo surgical treatment and who prior to~          scheduled surgery, provide informed consent and donate a 10-20 ml blood sample. After~          surgery, surplus tissues (including tumor and adjacent normal tissues) not required for~          diagnosis will be collected.~      Subject clinical information will be collected, including basic demographic information,~     medical history, current cancer history and treatment. A final pathology report will be~     obtained for each subject's surgical specimen. In some instances, and based on the cancer~     indications required, longitudinal data may also be collected at a frequency of every 6~     months to once per year. Longitudinal data will include information on study subject survival~     and disease recurrence.~   "
101439|NCT02239562|"~     The purpose of this study is to study the safety and tolerability of synthetic~     PreImplantation Factor (sPIF) in female patients with autoimmune hepatitis. Autoimmune~     hepatitis is a disease where the patient's immune system produces an inappropriate immune~     response against their own liver. PreImplantation Factor is a substance that is secreted by~     viable fetuses during pregnancy. PIF apparently initiates both maternal tolerance preventing~     the loss/rejection of the fetus. Synthetic PIF (sPIF) successfully translates PIF endogenous~     properties to pregnant and non-pregnant immune disorders. sPIF was found to be effective in~     preclinical models of autoimmunity and transplantation (published). Specifically sPIF~     protected the liver against immune attack. In FDA mandated toxicity studies (mice, dogs),~     high-dose sPIF administration for 2 weeks followed by 2 weeks observation period demonstrated~     a high safety profile. Based on those observations the FDA has granted a Fast Track~     designation for this trial. This study will evaluate the safety, tolerability and the blood~     level of this synthetic version of this natural compound in the circulation.~   "
101440|NCT02239549|"~     The purpose of this study is to evaluate and compare the incomplete resection rates for small~     colon polyps less than or equal to 6 mm in size using two conventional polypectomy tools,~     jumbo cold biopsy forceps and cold snare.~   "
101441|NCT02239536|"~     The complete removal of colorectal polyp is required to prevent tumor recurrence and~     development of potential interval cancers. However, several studies have shown high~     incomplete resection rate in endoscopic removal of neoplastic colorectal polyps larger than 5~     mm. The polypectomy techniques using hot snare are usually used for the removal of these~     polyps. However, the optimal technique for complete resection of these polyps is unknown.~     There are few data comparing hot snare polypectomy with hot snare polypectomy after saline~     injection for complete resection of colorectal polyps (5mm or larger). The aim of this study~     is to compare hot snare polypectomy with hot snare polypectomy after saline injection for~     removal of 5-10mm sized colorectal polyps.~   "
101491|NCT02238860|"~     Entacavir and tenofovir are two first line therapies for chronic hepatitis B. Both agents~     have been claimed equivalent in treatment, there are no head to head trials available in the~     literature about there effectiveness in HBV Decompensated Cirrhosis. The investigators aimed~     to compare safety/efficacy and virological response in patients with HBV Decompensated~     Cirrhosis.~   "
101442|NCT02239523|"~     Patients who present with fragility fractures are consistently under-evaluated and~     under-treated for underlying osteoporosis. This point of care represents a lost opportunity~     to prevent future fractures. The medical field treats the fracture as if the fall is the~     problem, but bone quality is the real problem. Studies have consistently shown that the~     recommendations of the International Osteoporosis Foundation and World Health Organization~     are not being followed. Orthopedics treats the patients for their fractures and primary care~     physicians focus on general health but no one is taking responsibility for bone health.~     Strategies to convince primary care to assume care have not succeeded. On the other hand,~     strategies where orthopedics takes some responsibility have shown success. This prospective~     2-arm study will evaluate the success of effort by an academic orthopedic department in~     osteoporosis evaluation and treatment. We hypothesize that with greater effort by the~     orthopedic department, the better the adherence to standards of care. A cost benefit analysis~     will be made in parallel.~   "
101443|NCT02239510|"~     In this prospective, randomized, double blind study, the aim is to determine the efficacy of~     Linaclotide in relation to Senna in relieving the symptoms of chronic idiopathic constipation~     (CIC). Patients with CIC, (age 18 - 70) will be enrolled in the study and randomized to Senna~     or Linaclotide. Patients will be asked to complete questionnaires during the study and will~     be followed for 12 weeks. Main outcomes include number of daily bowel movements and measures~     from surveys regarding bowel habits, relief, and satisfaction.~   "
101444|NCT02239497|"~     Proper management of acute postoperative pain (DAPO) is essential for the recovery of~     orthopedic surgeries. The blockade of the femoral nerve preincisional (BFP) is simple and its~     effectiveness increases guided by ultrasound and neurostimulation. OBJECTIVE: To evaluate the~     effectiveness of BFP in patients undergoing orthopedic surgery of the lower limbs under~     general anesthesia. METHODS: A comparative study was conducted, randomized, two groups,~     surgeries of the hip, femur and knee, ASA I-II, aged 18 years. Group B (n = 15) received BFP~     and ultrasound-guided nerve stimulation with 20 ml of bupivacaine 0.5% plus epinephrine 1:~     200,000. Group S (n = 15) without blocking. Both groups received intravenous analgesia with~     ketoprofen 100 mg regimen and dipyrone 1g c / 8 hs and balanced general anesthesia.~     Postoperative morphine 0.03 mgr / kgr / weight was administered if EVA ≥4~   "
101445|NCT02239484|"~     We investigate the potential pharmacokinetic drug-drug interaction between Tadalafil and~     Tamsulosin in healthy male volunteers who receive Tadalafil alone, Tamsulosin alone, and both~     together in a 3 period repeatedly.~   "
101446|NCT02239458|"~     Cystic fibrosis related diabetes (CFRD) is a common co-morbidity in patients with CF. The~     underlying pathophysiology of cystic fibrosis related diabetes (CFRD) is still a matter of~     investigation. In addition to localized tissue damage developing similar to that of the~     exocrine pancreas, other mechanisms may be involved. We have shown that a potential~     contributing factor to the patho-physiology of CFRD may be an abnormal gut derived hormonal~     profile, specifically of lower incretin hormone responses, prior to development of CFRD.~      We propose that an altered incretin response, probably due to impaired interaction of~     nutrients with the gut mucosa due to thickened secretions, may play a role in the development~     of the disease. Specifically, low GIP and GLP-1, may explain the poor β-cell function~     observed in these patients prior to CFRD appearance. These incretins have known trophic~     effects on β-cells, and thus their lower levels may contribute to the development of~     quantitative as well as qualitative defects in β-cell function and thus may lead to the~     development of CFRD. Thus, increasing levels of these incretins using a DPP-IV inhibitor may~     improve glucose metabolism and delay/prevent the development of CFRD.~      We hypothesize that Saxagliptin will increase the oDI compared to placebo and will thus~     provide relative protection from diabetes development and in addition we expect that~     Saxagliptin will lead to overall increased insulin concentrations and thus shift the~     metabolic milieu to a more anabolic state. This will manifest as weight gain and reduction in~     inflammation.~   "
101447|NCT02239445|"~     The purpose of this investigation was to test the hypothesis that intranasal dexmedetomidine~     is as effective as second dose of oral chloral hydrate for rescue sedation in infant age~     between 1 and 6 months who were not adequately sedated following initial dose of chloral~     hydrate.~   "
101448|NCT02239432|"~     Early adenocarcinoma of the lung has an excellent five-year survival after resection.~     However, its clinical and radiologic presentation is highly variable. Traditional means for~     preoperative diagnosis such as Positron Emission Tomography (PET-CT) and trans-thoracic~     needle biopsy demonstrate unacceptable false positive and negative rates.~      Telomere biology is activated aberrantly is most lung cancers but has not been studied in~     early stages to the best of our knowledge.~      The objective of this study is to evaluate telomere length and activity with suspected early~     stage adenocarcinoma of the lung.~   "
101449|NCT02239419|"~     Foot ulceration usually precedes more serious foot complications such as infection, gangrene~     or amputation. The risk of developing foot ulcers has been estimated to be higher in~     individuals with kidney disease. Patients with kidney disease receiving dialysis have an~     increased prevalence of critical limb ischemia. Carbon dioxide (CO2) foot bathing has been~     reported to improve subcutaneous microcirculation. The proposed clinical study will evaluate~     the therapeutic potential of CO2 enriched water (produced by the Carbothera device) on~     treating foot ulcers in patients with critical limb ischemia and undergoing hemodialysis.~     Forty individuals how have a distal extremity ulcer who are currently undergoing hemodialysis~     will participate in this study.~   "
101450|NCT02239406|"~     The purpose of this study is to determine if avascular necrosis of the acetabulum is present~     in metal-on-metal revisions and to what depth this dead avascular bone occurs.~      A convenient sample of a consecutive series of 15 patients treated for metal on metal~     acetabular revision surgery will be included.~   "
101492|NCT02238847|"~     The purpose of this study is to demonstrate non-inferiority of Fully Covered biliary SEMS to~     Uncovered biliary SEMS in biliary drainage for the pre-operative management of biliary~     obstructive symptoms caused by pancreatic cancer in patients undergoing neoadjuvant therapy.~   "
101493|NCT02238834|"~     This is a randomized, placebo controlled, single and multiple ascending dose study to assess~     the safety and tolerability and pharmacokinetics of FP-025 in healthy subjects.~      Note: Dosing in the SAD phase was completed, and the planned MAD portion of the study was not~     conducted. Evaluation of FP-025 MAD is being conducted under a separate protocol (Study No.~     FP02C-17-001).~   "
101451|NCT02239393|"~     The mechanism of action of MSC relies on their ability to modulate pathogenic immune~     responses and provide neuroprotection through the release of anti-apoptotic, anti-oxidant and~     trophic factors as demonstrated by in-vitro and in-vivo preclinical studies.~      Patients will be randomized to receive immediate vs. delayed treatment with either a dose~     equal to 1-2 millions/kg of body weight of autologous MSC, or equivalent volume of suspension~     media at baseline. At week 24 treatments will be reversed.~      The primary outcome of this study is to evaluate:~        -  Treatment's safety within one year from MSC administration by measuring the number,~          time-frame and severity of adverse events and~        -  Treatment's activity in terms of reduction in total number of gadolinium-enhancing~          lesions (GEL) by magnetic resonance imaging (MRI) scans.~      Secondary outcomes are to gain preliminary information on the efficacy of the experimental~     treatment in terms of combined MRI activity and clinical efficacy (incidence of relapses and~     disability progression).~   "
101452|NCT02239380|"~     The purpose of this study is to determine the efficacy, safety and pharmacokinetics of~     Lorazepam on Japanese patients with Status Epilepticus or Repetitive Status Eplilepticus.~   "
101453|NCT02239367|"~     The goal of this proposed pilot study is to test the feasibility and acceptability of a~     Depression Decision Aid (DDA) protocol integrated into the Electronic Health Record (EHR) and~     used by nurses with depressed ambulatory care patients. The Depression Decision Aid protocol~     is a streamlined adaptation of an in-person Shared Decision-Making (SDM) intervention, and~     its goal is to increase patient involvement in clinically appropriate treatment~     decision-making as a way of strengthening treatment engagement and outcomes. The protocol~     guides ambulatory care nurses in helping depressed patients (Patient Health Questionnaire-9~     [PHQ-9] >10) develop informed treatment preferences through a process of education and values~     clarification. We will target patients in the general medical clinic, whether currently~     receiving depression treatment or not, because depression is highly prevalent but often~     poorly managed in this population.~   "
101454|NCT02239354|"~     The purpose of this trial is to test if VC-01™ combination product can be implanted~     subcutaneously in subjects with Type 1 Diabetes and maintained safely for two years. It will~     also test if VC-01 is an effective treatment for subjects with Type 1 Diabetes.~   "
101455|NCT02239341|"~     The current standard of care for pregnant women deemed to be high-risk often involves~     recommending varying levels of activity-restriction, up to and including hospitalization.~     High levels of activity-restriction can lead to physical deconditioning of the mother, which~     can be difficult to recover from after birth. The proposed study will investigate whether a~     mild muscular conditioning program conducted in bed and given to hospitalized~     activity-restricted high-risk pregnant women will improve functional ability, cardiovascular~     deconditioning and overall quality of life in the postpartum period compared to a control~     group with no in hospital bed-rest exercise program. We hypothesize that women with a~     in-hospital muscle conditioning program will be better able to perform functional ability~     tasks and activities of daily living than a control group with no exercise program.~   "
101456|NCT02239328|"~     This survey study is looking to determine if patient reported outcomes(using the PROMIS~     survey) will vary according to the presence of recurrent or metastatic lung or esophageal~     cancer.~   "
101457|NCT02239315|"~     The purpose of this study is to find out if the pathological complete response (pCR) to~     chemotherapy given before surgery (neoadjuvant chemotherapy) could be predicted by the~     evaluation of the RNA (ribonucleic acids) disruption pattern (RNA Disruption Assay or RDA~     score) obtained from a biopsy of the tumor 7 - 14 days after the first, second and third~     cycles of chemotherapy treatment. If we can determine the optimal time during neoadjuvant~     chemotherapy to measure the RDA score for the prediction of pCR, we can optimize breast~     cancer management.~   "
101458|NCT02239302|"~     Obstructed defaecation syndrome is a common problem in which patients experience difficulty~     to evacuate stools and feel that the bowel is incompletely empty, which causes the need to~     put fingers in to the rectum or vaginal to empty the rectum. These symptoms have a~     significant effect on social, physical, emotional and sexual wellbeing all of which have~     impact on quality of life. These symptoms are caused by posterior compartment disorders such~     as the last part of the large bowel bulging into the vagina (rectocele), the small bowel~     pressing on the rectum (enterocele), a circumferential infolding of the rectal wall~     (intussusception) or paradoxical pelvic floor contraction during attempts to evacuate~     (anismus).~      Currently the evacuation proctogram is the gold standard for diagnosis of posterior~     compartment disorders. This technique, however, exposes the patient to ionising radiation,~     requires preparation of the small and large bowel with contrast and defaecation in a~     non-private setting, which most women find embarrassing and unpleasant. Over the years,~     research has focussed on identifying alternatives that are better tolerated to substitute~     evacuation proctography. Ultrasound is a widely available, non-expensive, non-invasive, fast~     and a well-tolerated method for the dynamic and static imaging of the pelvic floor without~     the use of ionising radiation. The level of agreement between transperineal ultrasound (TPUS)~     and proctography for varies widely. Endovaginal ultrasound (EVUS) not yet compared to~     proctography. The aim of this study is to assess the level of agreement between ultrasound~     (EVUS and TPUS) and evacuation proctography in the diagnosis of posterior compartment~     disorders.~   "
101459|NCT02239289|"~     The purpose of the present study is to evaluate the benefit of biofeedback training on the~     capacity of chronic low back pain patients to decrease their lumbar paraspinal muscles~     activity during trunk full flexion and its relationship with changes in clinical outcomes. To~     do so, twenty patients with nonspecific mechanical low back pain will be recruited and all~     participants will take part in four sessions of supervised biofeedback training, consisting~     of 5 blocks with at least 12 trunk flexion-extension tasks. It is hypothesized that~     participants will have improved neuromechanical parameters with the biofeedback training and~     that this improvement will be positively associated to changes in clinical outcomes. This~     study will also allow for generation of preliminary data, in order to plan for a larger~     randomized control trial.~   "
101460|NCT02239276|"~     This is an expanded access use of Stiripentol in Dravet Syndrome or epileptic~     encephalopathies associated with sodium channel mutations who have failed other drugs in an~     effort to give them the best chance at seizure control and quality of life. As a treatment~     protocol and not a research study, children will only be monitored on a clinical basis for~     seizure improvement and side effects predominantly by parent and caregiver report.~   "
101461|NCT02239250|"~     DelAgua Health Rwanda (Implementation) Ltd. together with Rwanda Ministry of Health (MoH) are~     delivering an intervention, consisting on the free distribution of one advance water filter~     and one improved cookstove to all household classified as ubudehe 1 and 2 according to~     government approved registers (poorest tertile), in Western Province. The aim of this~     intervention is to reduce the morbidity and mortality associated with diarrhoeal diseases and~     pneumonia in Rwanda.~      The London School of Hygiene and Tropical Medicine (LSHTM) will be undertaking an independent~     evaluation of this large-scale intervention to assess its impact on health. The trial will~     evaluate whether the provision of improved cookstoves and advance water filters can reduce~     pneumonia and diarrhoea disease in children under 5 years of age.~      A cluster randomized controlled trial (CRCT) with two arms of unequal size (3:1 ratio) will~     be use to answer this question. The 96 sectors in Western Province, Rwanda, will be~     randomised to either receive the intervention or the control. Each eligible household in~     intervention sectors will receive one EcoZoom™ Spartan and one Vestergaard Frandsen Lifestraw~     Family™ 2.1 water filter free of charge. Eligible households in control sectors will continue~     with their traditional cooking and drinking practices. Health data on children under 5 years~     of age will be collected from community health worker (CHW) and health facility records all~     across Western Province to evaluate the health impact of the intervention. The study will~     encompass 12 months of follow-up. After this time the control sectors will receive the~     intervention.~      This independent evaluation will also include a nested village-level study within the larger~     sector-level study, with the aim to evaluate uptake, consistent use and acceptability of the~     intervention, as well as to assess the impact on environmental exposures and health outcomes.~     174 villages (74 controls and 74 intervention) will be selected for participation. Household~     surveys will be used to collect data on intervention use and acceptability as well as on~     self-reported health data. Water samples will be collected and monitoring of exposure to~     Households Air Pollution (HAP) will be undertaken. Measurements of blood pressure, expirated~     Carbon monoxide (CO) and pulse CO-oximetry will be undertake in primary cooks and or children~     under 5 years of age. Additionally, as part of this nested study, two exploratory studies~     will also be conducted. One will be focused on assessing the potential of biomarkers as~     indicators of environmental exposures (mainly HAP and water quality) and health status, while~     the other exploratory sub-study will assess the reactivity of participants to the use of~     remotely reporting electronic sensors to measure target behaviours.~   "
101462|NCT02239237|"~     This registry aims to monitor the safety of Compound Kuh-seng Injection and to identify the~     potential risk factors for the adverse drug reactions. Compound Kuh-seng Injection is a kind~     of natural compound injection extracted from herbs Kuh-seng (Radix Sophorae Flavescentis) and~     Rhizoma Heterosmilacis Japonicae.~   "
101463|NCT02239224|"~     The purpose of this study is to assess the safety and tolerability profile of ATYR1940 in the~     treatment of adult patients with molecularly defined genetic muscular dystrophies~   "
101464|NCT02239211|"~     This is a phase II study to determine the safety and preliminary efficacy of a human~     monoclonal antibody (BTT1023) which targets the vascular adhesion protein (VAP-1) and its use~     in the treatment of patients with primary sclerosing cholangitis (PSC).~   "
101465|NCT02239198|"~     There are prevalent micronutrient and fiber deficiencies in a significant proportion of US~     population, particularly among the overweight or obese. Intensive lifestyle counseling~     results in modest, measurable dietary improvements and weight stabilization, yet falls short~     of restoring optimal nutritional status and metabolism. A carefully formulated nutritional~     supplement bar (referred to as the CHORIBAR) delivered in a whole food matrix may correct~     micronutrient deficiencies in overweight or obese adults and children. This may have a~     beneficial impact on traditional indices of insulin dysregulation and the metabolic syndrome,~     gut inflammation, redox status, immune function and DNA integrity, and may favorably~     influence weight change and fat distribution.~      The investigators believe that the improvements seen with CHORIBAR trials will be mediated at~     the level of generalized enhancement in cellular metabolism that are not readily achieved~     with lifestyle counseling alone. The investigators suspect this is due to many nutritional~     barriers, some of which are disproportionately borne by inner city populations, such as cost~     and access to healthy food. The investigators hypothesize that a nutritional supplement like~     the CHORIBAR will facilitate restoration of optimal nutritional status and improve metabolic~     and weight outcomes.~   "
101466|NCT02239185|"~     Aim of the study The aim of this study is to test the hypothesis that during laparoscopic~     hernia repair, disconnection of the hernial sac along with suture ligation of the neck is~     better than transperitoneal purse string suture around the hernial sac at the neck leaving~     the sac in continuity. Also to compare the two different laparoscopic techniques as regards~     operative time, recurrence rate, hydrocele formation, and other possible complications as~     bleeding, hematoma, injury of the vas and testicular atrophy and post-operative cosmetic~     results.~   "
101467|NCT02239172|"~     The purposes of this study is to evaluate and compare the safety, reactogenicity, and~     tolerability of the PA83-FhCMB vaccine candidate delivered at 4 dose levels with Alhydrogel~   "
101468|NCT02239159|"~     The investigators assume that transcutaneous electric acupoint stimulation (TEAS)~     pretreatment may activate the endogenous protective mechanism, as a result protect the~     patients against subsequent surgical stress pregnancy. And TEAS may induce the production of~     endogenous analgesic transmitters, so develop an anesthetic-sparing effect. The investigators~     believe this intervention will reduce the subsequent incidence, duration and severity of~     organ dysfunction, possibly reducing the morbidity, even mortality. So in this study, the~     investigators hypothesize that TEAS before anesthesia and during surgery would decrease the~     morbidity and mortality of postoperative complications in 30 days after digestive surgery in~     elderly patients .~   "
101469|NCT02239146|"~     This trial is conducted in Europe and the United States of America (USA). The aim of this~     trial is to evaluate the safety of escalating single doses of rFXIII (recombinant factor~     XIII, catridecacog) administered following first time myocardial revascularization requiring~     cardiopulmonary bypass (CPB).~   "
101494|NCT02238821|"~     The MET oncogene is known to sustain the Trousseau's syndrome in murine experimental models,~     featuring association of carcinogenesis with a blood procoagulant disorder. MET is frequently~     overexpressed in colorectal cancer, a tumor where venous thromboembolism (VTE) may occur in~     association with poor prognosis, but the biological and genetic factors that cause VTE are~     still obscure.~      The Investigators propose to study whether in patients harboring a surgically resectable~     colorectal cancer the MET oncogene is expressed and may be associated with a blood~     thrombophilic condition that favors the onset of VTE.~      These data would have two main implications: (i) for the first time, a direct genetic link~     between the MET oncogene and a procoagulant disorder would be demonstrated in humans; (ii)~     the procoagulant alterations would have diagnostic/prognostic significance for the~     identification of patients at risk for poor outcome, and implementation of appropriate~     therapeutic protocols.~   "
101517|NCT02238509|"~     Recent clinical studies have shown that the combination of lapatinib and trastuzumab has~     superior antitumor activity compared to either single drug in both neoadjuvant and metastatic~     setting and is well tolerated. According to this evidence, the combination of lapatinib and~     trastuzumab today offers a valid chemotherapy-free option, primarily for patients with~     pre-treated HER2-positive MBC~   "
101470|NCT02239133|"~     The study includes five (5) main stages: Screening, Enrollment, Size fitting, Usage and~     Termination.~      Subject screening will be held during visit one (1) and visit two (2) at the clinic.~      Initiation and Size fitting:~      All eligible subjects will undergo size fitting by a gynecologist / urogynecologist, during~     visit 2, to find the suitable size for her. The subject will use the ProVATE device of the~     chosen size at the clinic vicinity for about one (1) hour and for 40-80 hours at her home~     environment, to confirm that the chosen size is appropriate for the user. Each usage will be~     followed by a vaginal examination. In case the investigator will determine that the subject~     should be fitted with a different size of the ProVATE device the subject will repeat this~     stage with a different device size until the suitable size is confirmed by the investigator.~      Usage:~      The subject will use the ProVATE device for at least 28 days during a 45 days period, at her~     home environment, and fill a usage diary. Each device will be used for at least 24 hours. At~     least one (1) follow-up phone call will be held with the subject per a week. After 14 usage~     days or following at least two (2) usages (the latest of them) the subject will be scheduled~     for vaginal examination at the clinic (visit four (4)).~      End Of Use At the end of use the subject will return to the clinic (visit five (5)) for a~     vaginal examination and additional activities.~      The following questionnaires will be filled at baseline and end of study: Quality Of Life~     (QoL) and POP symptoms. Satisfaction and Ease Of Use questionnaires will be filled at the end~     of use (visit 5) Up to four (4) ProVATE device models will be tested in this study.~   "
101471|NCT02239120|"~     This trial will enroll approximately 6,000 patients with recent embolic stroke of unknown~     source (ESUS). Patients will be randomized to dabigatran or acetylsalicyclic acid (ASA) (1:1~     ratio) and have visits every three months. The study doctor may prescribe blinded concomitant~     ASA for pts with coronary artery disease but this is not mandatory. All Adverse Events (AEs),~     Serious Adverse Events (SAEs), outcome events will be recorded. The trial will conclude when~     the required number of stroke events are positively adjudicated which is estimated to take 3~     years (including 2.5 years of enrollment).~   "
101472|NCT02239107|"~     Polycystic ovary syndrome is a major endocrinological disorder affecting 5-8% of reproductive~     aged women. Anovulation is a major feature of the syndrome, managed primarily by clomiphene~     citrate. Failure to respond to clomiphene citrate is termed clomiphene resistance and second~     line treatment is either laparoscopic ovarian drilling or gonadotrophin ovulation induction.~     Although laparoscopic drilling is effective in restoring ovulation and achieving pregnancy,~     some women still remain anovulatory and infertile after the procedure. N-acetyl cysteine has~     emerged as a novel therapeutic adjuvant to laparoscopic drilling to improve ovulation and~     pregnancy rate.~   "
101473|NCT02239094|"~     The study proposes to conduct a pilot study of biological predictors of lurasidone response~     in bipolar depression.~   "
101474|NCT02239081|"~     This is a Phase 1, single center, single-ascending dose, randomized study~   "
101475|NCT02239068|"~     Hypothesis: The investigators hypothesize that more than 50% of the patients receiving~     enteric contrast material (ECM) < 2 hours of anesthesia/sedation would have residual gastric~     fluid volume (GFV) > 0.4 ml/kg. The investigators also hypothesize that measuring GFV by~     using region of interest in the CT technique is accurate compared to blind aspiration of the~     gastric contents with a syringe and a multi-orificed orogastric tube.~   "
101476|NCT02239055|"~     Despite expert opinion unconvinced of any value for hospitalization in caring for people with~     borderline personality disorder (BPD), this patient group still accounts for a significant~     proportion of adult acute mental health (AMH) admissions. Staff nurses generally voice~     negative perceptions of BPD, a view which is linked to an uncertainty of how to approach~     these patients, and difficulties leading to personal distress and burnout.~     Mentalization-based treatment (MBT) is an evidence based approach, focusing on the mental~     states of both self and others, developed specifically to treat BPD and facilitated~     successfully in specialised settings. MBT Skills training is a compact and cost effective two~     day workshop which equips generalist mental health nurses with a skillset enabling them to~     work effectively with BPD. MBT Skills training was first offered to staff nurses in Royal~     Cornhill Hospital, Aberdeen in 2013. This study aims to assess staff perceptions on the value~     of MBT skills training, evaluating how it impacts on clinical practice when working with BPD~     in AMH.~   "
101477|NCT02239042|"~     The aim of the present study was to evaluate the influence of LLLT on the recovery of the~     palatine donor site wounds after harvest connective tissue graft.~   "
101478|NCT02239029|"~     Although few studies have showed beneficial effect of platelet rich plasma (PRP) for~     osteoarthritis of knee (OA knee), only one study applied randomized, control method and none~     of them has the objective measurements such as balance test or muscle strength which were~     reported as decrease in patients with OA knees. We assess the analgesic effect and the extent~     of improved muscle strength and balance after PRP in patients with OA knee.~   "
101479|NCT02239016|"~     This study aims to study the temporal course of sickle nephropathy and assess novel~     biomarkers that can predict patients prone to nephropathy.~   "
101480|NCT02239003|"~     NMDA neurotransmission plays an important role in learning and memory. NMDA receptors were~     found to decrease in the frontal lobe and hippocampus of mild cognitive impairment. This~     study is a randomized, double-blind, placebo-controlled drug trial. All subjects will be~     allocated randomly to 2 groups: (1) NMDA-enhancer: DAOIB group (starting dose: 250-500 mg/d);~     (2) placebo group. The study period is 24 weeks. The investigators hypothesize that DAOIB may~     yield better efficacy than placebo for cognitive function in patients with mild cognitive~     impairment.~   "
101481|NCT02238990|"~     The following trial is a multicenter and prospective research trial of the colposcopy unit of~     luebeck university and the national research center in Borstel, Germany.~      The study is to identify and evaluate new biomarkers in human papilloma virus (HPV)~     associated malignancies and its preinvasive lesions of the cervix uteri. Fresh tissue samples~     being removed during conizations and/or hysterectomies are to be fixed in HOPE`s solution and~     analyzed according to their transcriptomes and methylosome. The hereby found candidates are~     to be validated using immunohistochemistry and RT [real-time] -PCR [polymerase chain~     reaction].~      The project is meant to be followed by continuous studies developing a new test describing~     the malignant potential of HPV associated genital lesions.~   "
113678|NCT02079480|"~     The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics (PK)~     and pharmacodynamics (PD) of BMS-986090 in healthy subjects.~   "
101482|NCT02238977|"~     The proposed study will evaluate the response and remission rates for major depressive~     disorder (MDD) in end-stage renal disease (ESRD) patients undergoing maintenance hemodialysis~     (HD) treated with bupropion or fluoxetine for 12 weeks. In addition, the study will document~     the relative tolerability and safety, and longitudinally contrast the effects of bupropion~     and fluoxetine on measures of cognitive function, fatigue, inflammation, and tryptophan (TRP)~     and TRP catabolites in blood. It is hypothesized that both drugs will significantly reduce~     MDD symptoms from baseline, and be tolerable and safe, but bupropion will be associated with~     greater reduction in pro-inflammatory cytokines, cognitive impairment, and fatigue compared~     with fluoxetine.~      The Specific Aims of this study are:~      Aim 1: Determine the efficacy of bupropion and fluoxetine in treatment of MDD in ESRD/HD~     patients.~      Aim 2: Determine whether longitudinal change in MDD symptoms, cognitive dysfunction, and~     fatigue differ between bupropion and fluoxetine.~      Aim 3: Determine whether longitudinal change in MDD symptoms, cognitive dysfunction, and~     fatigue correlate with change in inflammation, measures of TRP availability to brain, or~     neurotoxic TRP metabolites.~      Hypotheses:~        1. Bupropion and fluoxetine will both show efficacy in treating MDD;~        2. Bupropion will lead to greater improvement in cognitive dysfunction and fatigue than~          fluoxetine; and~        3. Change in cognition and fatigue over time will correlate with change in c-reactive~          protein (CRP) and quinolinic acid and change in overall depression score will correlate~          with measures of TRP availability.~   "
101483|NCT02238964|"~     ROCSS is a randomised controlled trial of the placement of a biological mesh at the site of~     stoma closure. Our hypothesis is that reinforcing the stoma closure site with a collagen mesh~     (Strattice®) is superior to the standard technique in preventing herniation at 2 years.~   "
101484|NCT02238951|"~     The purpose of this study is to compare nurse-led care coordination for persons receiving~     cancer chemotherapy treatment incorporating mobile health technology to nurse-led care~     coordination without any mobile health enhancements.~   "
101485|NCT02238938|"~     Currently, colonoscopy is the safest way to detect bowel tumors and polyps, since these can~     be biopsied and removed in one working process. If the size of adenomas is larger than 2 cm,~     resections are usually done in a hospital setting. For the resection of large adenomas,~     different approaches can be used. The so-called piecemeal resection is done with snares, to~     cut off parts of the adenoma piece by piece until the whole adenoma is resected. This~     technique is the standard therapy, but is not required for very large adenomas, which can~     often show cell alterations that indicate cancer. Therefore these adenomas should be resected~     in one piece. This is done by the so-called en-bloc resection. For this kind of therapy,~     different endoscopic knifes are use to cut off the adenoma as a whole. Both resection~     techniques are done usually by previous injection of saline or other liquids to elevate the~     lesion from its bottom tissue.~      Although the piecemeal resection of large adenoma is the standard therapy, it shows~     recurrence rates of 10 to 25%, which afford repeated therapies and follow up controls.~     En-bloc resections, though, are expected to have less recurrence rates but are much more~     complex to perform. They have higher complication rates especially in the West, where it has~     bee introduced only a couple of years ago.~      The data situation regarding safety and efficacy of both therapies is low. This study is the~     first one ever to compare piecemeal EMR and ESD in a randomized way. The study might have~     influence on the logistics of future adenoma processing and patient flow.~   "
101486|NCT02238925|"~     The purpose of this study is to assess the effects of CPX-351 on cardiac repolarization,~     assess plasma drug levels, asses serum copper levels, and assess drug levels in urine.~      Efficacy and Safety will be assessed in all patients enrolled to the study.~   "
101487|NCT02238912|"~     this study is intended to find out the therapeutic efficacy of the siddha drug Kandhaga~     Rasayanam in Padarthamarai ( Ring worm infection )~   "
101488|NCT02238899|"~     The Register is based on the study HIT 2000 that recruited patients until 31.12.2011. All~     german patients with intracranial medulloblastoma, CNS-PNET, ependymoma can be included in~     the register. Object of the register is to maintain the quality of diagnostic standard by~     using of central review (Neuroradiology, Pathology, and cranio spinal fluid (CSF) cytology).~      Furthermore, the register should enable to continue the collection of epidemiologic data and~     biological material (tumor material, CSF, and blood) for associated studies.~   "
101489|NCT02238886|"~     The purpose of this study is to determine whether a goal directed nutritional intervention~     can reduce the convalescence period for patients undergoing radical cystectomy (RC).~      The aim is to examine the effect on quality of life of a standard nutritional strategy of~     resting the bowel till clear signs of bowel recovery and feeding orally after bowel recovery~     versus a goal-directed nutritional intervention combining oral intake and parenteral~     nutrition, in patients undergoing RC.~   "
101490|NCT02238873|"~     Granulocyte colony stimulating factors (GCSFs) stimulate the level of white blood cells,~     specifically neutrophils. GCSF support for patients receiving chemotherapy was shown to~     decrease the rate of fever during low neutrophil count (neutropenia), and in some cancer~     types may decrease mortality. Pegfilgrastim is a pegylated form of the GCSF named filgrastim.~     Pegfilgrastim is used to stimulate bone marrow to produce more neutrophils to fight infection~     in patients undergoing chemotherapy. It has a much longer half-life than the parent~     filgrastim. It is removed from the body within the neutrophils. According to the American~     Society of Clinical Oncology 2006 guidelines pegfilgrastim should be given 24 hours after the~     completion of chemotherapy i.e.before neutrophil count starts to drop. Therefore it is~     cleared before and after neutropenia. Comparative low quality studies suggest that deferring~     pegfilgrastim delivery until neutrophil counts start dropping may result in improved its~     efficacy. This was further tested in a few small randomized controlled trials (high quality~     studies, considered the gold standard of studies) in different settings (including first~     chemotherapy for lymphoma, and solid cancer) with inconsistent results. Pegfilgrastim (given~     24 hours after completion of chemotherapy) is a standard part of any salvage chemotherapy for~     patient with refractory or relapsed aggressive lymphoma. The investigators plan a randomized~     controlled trial comparing the efficacy of pegfilgrastim given 72 hours (day +3) vs. 24 hours~     (day +1) after completion of salvage chemotherapy in patients with refractory or relapsed~     aggressive lymphoma. The investigators will evaluate whether that change of pegfilgrastim~     schedule affects the risk of fever during neutropenia, neutrophil count, length of~     hospitalization, mortality, and safety.~   "
101495|NCT02238808|"~     Some breast cancers have estrogen receptors (ER+). The investigators know that some ER+~     tumours can be cured by hormone therapy alone while other ER+ breast cancers cannot.~     Currently, there is no perfect way to tell these groups apart nor do the investigators know~     why some respond when others do not.~      Research findings suggest that the two types of ER+ breast cancers differ in their response~     to estrogen with estrogen being toxic to one type and not the other. For those tumours that~     find estrogen toxic, this may explain why tumours only start to grow when estrogen levels~     decrease after menopause.~      The purpose of this study is to see whether a two-week treatment of estrogen equal to~     pre-menopausal estrogen levels will decrease the rate at which patients' ER+ tumours grow.~     This will be done by comparing the growth rate in the tissue removed during standard of care~     surgery after patients have been treated with 7-14 days of estrogen prior to that surgery.~   "
101496|NCT02238795|"~     Sepsis-associated Purpura fulminans (SAPF) is a rare life-threatening condition. It is~     characterized by multiple skin lesions which rapidly progress to necrosis and gangrene. SAPF~     is a manifestation of widespread clot formation in small blood vessels which emerges~     secondarily to severe bacterial and viral infections. The clinical presentation of SAPF is~     dominated by symptoms of severe sepsis and multiple organ failure which are further~     aggravated by the massive skin lesions.~      At present, there are no evidence-based guidelines for the medical management of SAPF. With~     numerous therapeutic approaches in use, there are no consistent comparisons of their~     efficacy. Altered role of causal pathogens following the introduction of meningococcal and~     pneumococcal prophylactic vaccines also remains to be investigated.~      The goal of the registry is comprehensive collection and evaluation of information concerning~     the epidemiology, morbidity, therapy and outcome of SAPF.~   "
101497|NCT02238782|"~     To assess the absolute bioavailability of oral selumetinib in healthy male volunteers~   "
101498|NCT02238769|"~     18F-FluoroethylCholine (18F-FECH) is a new tracer used in PET synthesized by Nuclear Medical~     Center of Peking Union Medical College Hospital and is favored for diagnosis of primary brain~     tumor. Although 18F-FECH showed a high presence of biological distribution in liver, 18F-FECH~     PET may have a higher sensitivity in diagnosis of intra- and extra-hepatic lesions of HCC~     respectively than those of 18F-FDG or 11C-acetate PET scan, and 18F-FECH PET could be a~     promising tool in diagnosis and staging, therapy selection and prognostic evaluation for HCC~     patients. However, much more cases are required to verify this theory. The purpose for this~     study is to establish the model of clinical experimental prospective study, and to evaluate~     the sensitivity, specificity and accuracy of 18F-FECH PET in diagnosis of HCC.~   "
101499|NCT02238756|"~     The purpose of this clinical trial is to investigate the safety and tolerability of IM~     administered CV8102 and an IM administered combination of CV8102 and rabies vaccine in~     humans.~   "
101500|NCT02238743|"~     The objective of the Project ADOPT- Ventral Hernia case-series is to collect clinical outcome~     data following the completion of a hands-on proctorship training model in laparoscopic~     ventral hernia repair.~   "
101501|NCT02238730|"~     To evaluate the equivalent efficacy of ultrabrief pulsewidth right unilateral~     electroconvulsive therapy versus bitemporal brief pulse electroconvulsive therapy in the~     treatment of depression and to evaluate the cognitive effects of ultrabrief right unilateral~     electroconvulsive therapy versus bitemporal brief pulse electroconvulsive therapy.~   "
101502|NCT02238717|"~     This study will examine the activity of 2 different doses of PF-06372865 on a panel of evoked~     pain tests carried out from 0.5 to 10 hours following oral dosing in healthy male subjects.~   "
101503|NCT02238704|"~     The World Health Organization (WHO) now recommends prenatal calcium supplementation for~     prevention of preeclampsia in populations with inadequate dietary intake. This study seeks to~     compare the effect of two dosing strategies on the amount of supplement ingested by pregnant~     women and adherence to related recommendations.~   "
101504|NCT02238691|"~     Continuous positive pressure during anesthetic induction is today not routinely used partly a~     to the risk of gastric insufflation because of higher ventilatory pressures. However there~     are conflicting data with improvement of GERD symptoms in CPAP treated OSA patients. The~     investigators aim to compare the risk of gastric insufflation regarding mask ventilation~     technique, with or without positive end expiratory pressure. For measurements a High~     Resolution Impedance Manometry Catheter is used.~   "
101505|NCT02238678|"~     It has been demonstrated that ligaments, both cardinal and uterosacral contain a considerable~     amount of autonomic nerve tissues. The resection of deep infiltrating endometriotic nodules~     at the level of the uterosacral ligaments or the rectovaginal space is supposed to damage the~     supplying autonomic nerve fibers of the lower urinary tract. The bladder receives motor and~     sensitive innervations from both the sympathetic fibers, most of which arise from the~     hypogastric plexuses and nerves, and the parasympathetic fibers, which arise from the pelvic~     splanchnic nerves and the inferior hypogastric plexus; therefore, even bladder function may~     be impaired in women affected by deep endometriosis.~      Very few data have been published regarding the urodynamic functional evaluation of bladder~     in patient with deep endometriosis.So far, it is unknown if the surgery itself causes the~     postoperative bladder dysfunction or if the surgery unmasks a subclinically pre-existing~     detrusor pathology.~      Since the urinary postoperative complications have a strong impact on quality of life of the~     deep endometriosis patients and often requires management (due to a poor spontaneous~     remission), it is crucial a better understanding of the problem. That will help for a more~     appropriate pre-operative counselling.~      Aims of this study are to evaluate the bladder function before and after deep endometriosis~     surgery, using standardized validated instruments and to correlate the localisation of the~     endometriosis lesion, the type/area of surgical dissection with the postoperative bladder~     function.~      This is a prospective multicenter cohort study involving the Department of General~     Gynaecology and Gynecological Oncology of Medical University of Vienna (Austria) and the~     Department of Obstetrics and Gynaecology of Insubria University, Varese (Italy).~      A total of 50 patients are planned to be included. The study protocol consider a Preoperative~     Assessment (clinical examination, transvaginal pelvic ultrasound, preoperative specific~     questionnaire including obstetric, medical, and surgical history and standardized questions~     on pelvic floor dysfunctions, standardized instrumental assessment of the pelvic floor) a~     Intraoperative Assessment (during laparoscopy, the localizations of endometriotic lesions~     recorded and identified by anatomical sites, numbers, and depth of infiltration). Before and~     3 months after surgery a Urodynamic assessment is planned.~   "
101506|NCT02238665|"~     Differential diagnosis between Ulcerative Colitis (UC) and Crohn's disease (CD) is of pivotal~     importance for the management of Inflammatory Bowel Disease (IBD) as both entities involve~     specific therapeutic management strategies. Confocal Laser Endomicroscopy (CLE) allows on~     demand in vivo characterization of architectural and cellular details during endoscopy. Here,~     we assessed the efficacy of CLE to differentiate between UC and CD.~   "
101564|NCT02237898|"~     Through a smartphone platform, financial incentives for smoking abstinence in postpartum~     women can be delivered remotely, thus minimizing the need for participants to come to the~     office to receive traditional contingency management.~   "
101507|NCT02238652|"~     Improving quality of life (QoL) in residents of nursing homes:~      A cluster randomized clinical trial of efficacy - The KOSMOS study.~      COSMOS (COmmunication (Advance Care Planning - ACP), Systematic pain assessment and~     treatment, Medication review, Occupational therapy, and Safety) is a practical intervention~     aimed to improve clinical and psychiatric challenges in NH patients. The COSMOS intervention~     combines the most effective research results to improve staff competence and patients' mental~     health, safety, QoL. We also aim to reduce psychotropic drug use and costs.~   "
101508|NCT02238639|"~     The primary objective is to demonstrate the clinical benefits of an active strategy for the~     diagnosis and treatment of PE compared to usual care in patients with unexplained~     exacerbations of COPD who require hospital admission.~      The secondary objective is to assess the safety of an active strategy for the diagnosis and~     treatment of PE compared to usual care in patients with unexplained exacerbations of COPD who~     require hospital admission.~   "
101509|NCT02238626|"~     This is a single center, randomized, double-blind, placebo-controlled, 6-month study designed~     to evaluate the safety, tolerability and clinical responsiveness of MN-166/ibudilast (60~     mg/day) when administered as an adjunct to riluzole (100 mg/day) in 60 subjects with ALS.~      This study will consist of two treatment arms, MN-166 and matching placebo. Randomization~     will occur in a 2:1 ratio (MN- 166: placebo).~      Duration of Treatment: Screening Phase: up to 3 months; Double-blind Phase: 6 months;~     Open-label Phase 6 months (for placebo subjects only); Follow-up Phase: 2 weeks after last~     dose.~      During treatment phase, subjects return to the clinic at Months 3 and 6 and will be~     telephoned by staff at Months 1,2,4, and 5 to collect information about side effects and new~     or concomitant medications.~      All subjects (subjects who complete the Double-blind Phase and subjects who complete the~     Open-label Phase) or prematurely discontinue will return for a follow-up visit approximately~     2 weeks after the last dose of study drug to assess adverse event status and to document~     concomitant medications.~      Safety will be assessed by monitoring and recording all treatment-emergent adverse events~     (TEAEs) including serious adverse events (SAEs) and discontinuations due to TEAEs. Additional~     assessments will include regular monitoring of hematology, blood chemistry, and urine values,~     regular measurement of vital signs, ECGs, medical history, physical and neurological~     examinations.~   "
101510|NCT02238613|"~     The purpose of this study is to determine whether radioactive stents and common used plastic~     stents are effective and safety in the treatment of unresectable biliary tract cancer.~   "
101511|NCT02238587|"~     To study the effect of Ganoderma Spores Powder Capsules on the life quality and immunity~     status of the patients with head-and-neck cancer after complete treatment (including surgery~     and / or radiotherapy and/or chemotherapy)~   "
101512|NCT02238574|"~     Despite improvements in therapy, head and neck carcinomas still have a poor prognosis with a~     5-year survival of ~ 50%. Malignancies of the head and neck area are (almost) always preceded~     by precursor lesions. Treatment of these premalignant mucosal abnormalities is generally~     limited and not very inconvenient for the patient. If this precursor lesion remain untreated,~     it may develop into a malignancy of the head and neck. Extensive treatment will be necessary.~     This means loss of function of the mouth, eg chewing, speaking and swallowing.~      The hypothesis is that chromosomal instability (CIN) detected by fluorescence is situ~     hybridization (FISH) is a reliable indicator for progression to malignancy. By intensifying~     the follow up and treatment in premalignant CIN lesions, the incidence of progression to~     invasive carcinoma is expected to be significantly reduced. If this hypothesis is justified,~     there will be a place for CIN detection as a risk indicator in the diagnostic work up of~     premalignant lesions in the head and neck.~      The investigators second hypothesis is that loss of heterozygosity (LOH) detected bij DNA~     markers is a reliable indicator for progression to malignancy. By intensifying the outpatient~     clinic follow up and treatment in premalignant lesions, the incidence of progression to~     invasive carcinoma is expected to be significantly reduced. If this hypothesis is justified,~     there will be a place for CIN and LOH detection as a risk indicator in the diagnostic work up~     of premalignant lesions in the head and neck.~   "
101513|NCT02238561|"~     The investigators will examine the relationship between post-operative oxygen consumption~     (using non-invasive measurement technology ) and complications in patients having~     contemporary major abdominal surgery. The investigators hypothesis is that major surgery may~     trigger a physiological stress response that results in an increase in post-operative~     metabolic demand and oxygen consumption (V̇O2) which must be met by an increased oxygen~     delivery (DO2).~        1. To determine the feasibility of non-invasive measurement of oxygen consumption (V̇O2)~          using indirect calorimetry in a cohort of patients~        2. To determine the feasibility of non-invasive measurement of oxygen delivery (DO2) in the~          same cohort using non-invasive measures of cardiac output, oxygen saturation and~          haemoglobin (pulse wave transit time and co-oximetry techniques)~   "
101514|NCT02238548|"~     Rationale: Infections are an important worldwide cause of death, both in elderly and young~     children. Therefore, support of immunity could help to reduce the incidence of infections. To~     screen the potential of specific foods or food ingredients to support immunity, oral~     vaccination can serve as a model. In this study, oral cholera vaccination will be applied in~     human adult volunteers, and used as a model to study the support of the immune response by~     raw milk.~      Objective: To investigate whether raw milk is able to enhance the immune response as induced~     by oral cholera vaccination.~      Study design: The study is designed as a single-blind randomized controlled trial of 4 weeks.~      Study population: Healthy subjects of 18-50 years of age.~      Intervention: Raw milk, obtained from farms that comply to the high quality requirements for~     production of raw milk, and that has been screened according to the safety criteria for raw~     milk.~   "
101515|NCT02238535|"~     To assess the effectiveness of the synthetic analogue of prostacyclin in postembolic residual~     pulmonary hypertension.~   "
101516|NCT02238522|"~     The purpose of this study is to determine safety, tolerability, dose limiting toxicities~     (DLT) and maximum tolerated dose (MTD) of ZEN003365 in patients with relapsed/refractory~     lymphoproliferative malignancies (LPM) or relapsed/refractory acute myeloid leukemia (AML).~   "
101683|NCT02236351|"~     This project will assess whether there is a significant difference in compliance with~     patching in amblyopic patients whose parents are instructed to pinch the superior and~     inferior edges of the patch before applying (in order to improve comfort) versus patients~     whose parents are instructed to place the patch evenly around the orbit.~   "
101518|NCT02238496|"~     The purpose of this study is to test the effectiveness of a drug called temsirolimus in~     combination with a drug called perifosine in treating brain tumors that have continued to~     grow after previous treatment. Temsirolimus is an intravenous drug approved by the FDA for~     treatment of other cancers (kidney cancer, certain types of lymphoma) but not for brain~     tumors. Perifosine is a pill that has not been approved by the FDA which blocks a messenger~     that tells cancer cells to grow. Research suggests that combined treatment with both drugs is~     better than either alone, and that it is reasonably safe.~   "
101519|NCT02238483|"~     The purpose of this study is to determine whether AZD7624 can reduce acute Chronic~     Obstructive Pulmonary Disease (COPD) exacerbations in patients on COPD maintenance therapy~     with a history of frequent acute exacerbations.~   "
101520|NCT02238470|"~     The purpose of this study is to determine whether Magnetic Resonance Imaging may predict the~     risk of Intracerebral Hemorrhage for patients with ischemic stroke who receive indefinite~     oral anticoagulation~   "
101521|NCT02238457|"~     The sympathetic nervous system, a part of the nervous system that stimulates the heart via~     release of substances, noradrenaline and adrenaline (combined called catecholamines), becomes~     activated in people with heart failure. As these people become sicker, the nervous system~     becomes more active, causing further damage to the heart.~      Large trials have shown that Angiotensin-converting enzyme (ACE) inhibitors reduce morbidity~     and mortality in patients with heart failure. Higher doses of these drugs are more effective~     than lower doses. Studies show that ACE-inhibitors decrease catecholamine levels. This could~     be why congestive heart failure (CHF) patients taking this class of drugs show improvement in~     heart function.~      There are several ways of measuring the activity of the sympathetic nervous system. The most~     common measurement is to test the blood for catecholamine levels. This is not very reliable~     or reproducible. Microneurography is a new technique used to measure sympathetic nerve~     activity. A small electrode (comparable to an acupuncture needle) is placed in a muscle nerve~     and hooked up to a stimulator and a recorder. It produces direct recordings of skeletal~     muscle nerve traffic. Both the rate and amplitude of the burst can be measured. The results~     in this technique are highly reproducible. By using this technique we get a more accurate~     picture of how the nervous system responds to medications given to treat heart failure.~      Losartan (Cozaar) is an angiotensin II type 1 (AT1) receptor blocker. It blocks the binding~     of angiotensin II, a hormone that constricts blood vessels. As a result the blood vessels~     remain relaxed, leading to a reduction in the workload of the heart. Minor decreases in blood~     catecholamine levels have been reported with a low dose of this drug. The purpose of this~     study is to see whether a high dose of losartan (200 mg) has a greater effect on the~     sympathetic nervous system than a low dose of losartan (50 mg) does.~      A total of 30 participants will be recruited. Participants will be assigned to one of two~     groups: high-dose, in which subjects will receive treatment of 200 mg/day of losartan, and~     low-dose, in which subjects will receive treatment of 50 mg/day of losartan. Via~     microneurography the investigators will measure the difference in sympathetic activity in~     subjects in high-dose vs low-dose losartan. The investigators expect to see further decrease~     in sympathetic activity in high-dose group than in low-dose group.~   "
101522|NCT02238444|"~     The purpose of this study is to determine whether Warfarin Anticoagulation are effective and~     safe in Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients with Hypersplenism~     after Laparoscopic Splenectomy.~   "
101523|NCT02238431|"~     Currently all patients that have freeze-all ICSI treatment cycles have the start of their FET~     cycle scheduled with the use of OCP. While an excellent pregnancy rate (75%) for the patients~     that have a blastocyst transfer has been maintained over time, 15% of started FET cycles are~     being cancelled because of premature luteinization, and the treatment (to transfer) takes~     approximately 89 days. The use of a Lucrin depot may reduce the number of cycles cancelled~     and reduce the treatment time to approximately 69 days. The use of no drugs and allowing the~     normal menstrual cycle to determine the time to start the FET cycle may suit some patients.~     Whether these benefits can be obtained while still maintaining the current FET pregnancy rate~     will be the main focus of the trial.~   "
101524|NCT02238418|"~     Vitamin D is not seen anymore only as a phosphocalcic and bone hormone, but also as having an~     effect on global health (anti-infective, anti-inflammatory, anti-tumour roles and~     cardiovascular protection).~      Until recently, vitamin D repletion was defined as the minimal concentration that enables the~     prevention of rickets in children and osteomalacia in adults, i.e, approximately 8 ng/mL (20~     nmol/L). However, most of the international experts agree to set minimal threshold of 25 OH~     vitamin D serum concentration, higher than the one previously admitted, with a limit of 20~     ng/mL (50 nmol/L) to define a vitamin D deficiency and a limit of 30 ng/mL (75 nmol/L) to~     define vitamin D insufficiency.~      Recommendations for Vit D supplementation in healthy children were updated in France in 2012.~     The invariable supplementation of infants and toddlers is efficient since deficiency-related~     rickets have almost disappeared; however there is very few information in ill children~     populations.~      Vit D supplementation tolerance is usually considered as good and over-dosage risks are low,~     however these studies were conducted more than 30 years ago, and as far as we know, there is~     no study about calcium urinary excretion kinetics after intake of a 100 000 IU vial of~     cholecalciferol (Uvedose®). When 25 OH vitamin D serum concentrations exceeds 200 ng/mL,~     which is very rare in daily practice, toxic effects of Vit D may theoretically be observed,~     particularly hypercalcemia and hypercalciuria.~      Vitamin D deficit is very common in children with chronic kidney disease (CKD) with a 50 to~     92% prevalence depending on the studies; it it is a risk factor for secondary~     hyperparathyroidism.~      Although international guidelines regarding the care of CKD children recommend 25 OH vitamin~     D serum concentrations over 75 nmol/L, there are no practical recommendations in terms of~     dose and frequency of native Vit D treatment.~      Therefore, the objectives of the present study has are the following:~        -  to validate prospectively the efficacy of our service usual care for Vit D~          supplementation of children and adolescents seen in the paediatric nephrology~          department.~        -  and to study the effect of Vit D supplementation (100 000 IU vial of cholecalciferol) on~          calciuria in these patients.~   "
101525|NCT02238405|"~     The primary focus of this intervention trial is to understand the effect of quitting smoking~     on TB treatment outcomes. The investigators will compare a cessation strategy based on~     guidelines recommended by the World Health Organization (WHO) and the International Union~     against Tuberculosis and Lung Disease (IUTLD). This is currently not utilized in TB directly~     observed therapy (DOT) clinics in Pakistan. The investigators study will provide~     comprehensive data towards understanding the effectiveness of these strategies for TB~     patients who smoke in Pakistan, and most importantly, on the effect of quitting smoking on TB~     treatment outcomes. These findings will guide development of effective smoking cessation~     strategies in a region with high prevalence of TB and increasing tobacco use.~   "
101526|NCT02238392|"~     This study investigates impact of adenosine versus AF inducibility and subsequent termination~     on the acute and long-term outcome of paroxysmal AF ablation.~   "
101527|NCT02238379|"~     The objective of this study is to investigate the effects of oxytocin on social behavior and~     brain activity using EEG and the event-related potential (ERP) technique. The value of EEG is~     its high temporal specificity, enabling precision in the timing of social behavior to be~     addressed. In order to elicit social responses in the human brain, a variety of social and~     emotional visual stimuli will be presented during EEG recording, namely infant and adult~     faces and houses. Brain responses after intranasal oxytocin will then be compared with~     placebo, to examine the effect of intranasal oxytocin on central nervous system activity. We~     hypothesize that intranasal oxytocin will enhance the neural response to social stimuli~     (infant and adult faces) but not to non-social stimuli (houses).~   "
101528|NCT02238366|"~     The purpose of this study is to collect some parameters which may help to provide guidance on~     how Androgen Deprivation Therapy (ADT) drugs are renewed and physician satisfaction.~   "
101529|NCT02238353|"~     Comparative analysis of the efficacy of intranasal MP29-02 (a novel formulation of azelastine~     and FP) has already been conducted in patients with moderate-to-severe seasonal AR. The~     combination formulation appeared to be superior in these patients with better symptomatic~     relief. However, objective analysis of the effect of this treatment on nasal mediators and/or~     nasal hyperreactivity has not yet been performed and would help in understanding the~     additional benefit of the combination treatment over monotherapy with nasal corticosteroids.~   "
101530|NCT02238340|"~     Inadequate control of acute postoperative pain (DAPO) brings deleterious consequences for the~     patient, including significant cardiovascular and respiratory complications. Apart from the~     human suffering that is undeniable pain. Schemes oral analgesia with opioids for the~     treatment of DAPO, have shown to be as or more effective than intravenous or epidural~     regimes, and less expensive. Comparing the effectiveness of 10 to 20 mgs of oxycodone~     sustained release for 12 hours before surgery, into two groups of 20 patients (O-10, O-20)~     undergoing orthopedic surgery, in a scheme involving multimodal ketoprofen, dipyrone~     metoclopramide and dexamethasone. Values were recorded visual analog scale (VAS)for pain at~     rest and effort, requirement for rescue intravenous morphine and incidence of side effects to~     the entry and exit of the PACU (T0, TE) and at 6 and 18 hours postoperatively (T6, T18),and~     patient satisfaction.~   "
101531|NCT02238327|"~     The overall hypotheses of this proposal are that discrete phenotypes of HIV Chronic~     Obstructive Pulmonary disease (COPD) differ in their trajectories, biomarkers, and risk~     factors and that persistent viral infection including residual HIV is linked to HIV COPD.~   "
101532|NCT02238314|"~     The primary objective was to evaluate the antiviral activity and safety of two regimens of~     tipranavir (500 mg BID or 1000 mg BID) plus ritonavir (100 mg BID) administered in~     combination with 1 new nucleoside reverse transcriptase inhibitor (NRTI) + efavirenz in~     multiple protease-inhibitor-experienced HIV-1 positive patients.~   "
101533|NCT02238301|"~     The purpose of this study is to evaluate the use of functional MRI in pregnant women as a~     non-invasive diagnostic tool to detect placental insufficiency and differentiate healthy~     fetuses from the intra-uterine growth restricted ones. Functional MRI in pregnant women can~     detect a variation of the MRI signal (called BOLD effect) from the placenta and the fetus~     when the mother is breathing pure oxygen. This study aims hence to demonstrate the difference~     in the BOLD effect between normal feto-placental units and growth restricted ones.~   "
101534|NCT02238288|"~     Patients using anticoagulants present an increased risk of bleeding when subjected to oral~     surgery. Suspending or reducing the oral anticoagulant dose to perform invasive procedures,~     may result in thromboembolic events, putting patients health in risk. Recent studies advocate~     the dental surgery treatment without suspending the anticoagulant therapy, since the values~     of the international normalized ratio (INR) are in acceptable therapeutic levels and local~     measurements are taken for the hemostasis control. The aim of this study is to compare the~     effectiveness use of intra-alveolar epsilon amino caproic acid (EACA) associated to daily~     rinses with the drug, with routine post-surgical procedures, to control the post-exodontic~     bleeding in anticoagulated patients. Patients will be referred by the anticoagulation clinic~     of the Clementino Fraga Filho University Hospital. Once the study criteria is met patients~     will be randomly allocated into two groups and subsequently subjected to clinical and~     periodontal examination, radiographic examination and pre-operative periodontal therapy.~     Laboratory tests (partial thromboplastic time, prothrombin time, international normalized~     ratio and platelet count) will be held on the day of the extraction. Patients in group 1 (~     EACA ) will receive a paste composed of 01 macerated EACA tablet (500 mg), mixed with 0.9%~     saline solution in the alveolar socket, and routine post-operative care. Additionally,~     patients will perform oral rinses three times a day, on the first two post-operative days,~     with a solution from the macerated EACA 500mg tablet diluted in 2 spoons of filtered water.~     Patients allocated in group 2 (control) will receive routine post-operative care.~     Classification of immediate bleeding will be held by the professional, on the day of the~     surgery, immediately after the suture and twenty minutes later and the delayed bleeding,~     recorded by the patient through a daily questionnaire. The Statistical Package for the Social~     Sciences (SPSS)© (IBM, Chicago, USA) 20.0 is used as the database and the Chi-square,~     Kruskal-Wallis and Mann-Whitney tests will be applied to statistical analysis of the~     results.The study was approved by the ethical and research committee of the Clementino Fraga~     Filho University Hospital . All patients will sign a free consent and informed term.~   "
101535|NCT02238275|"~     Study to evaluate efficacy and tolerability of Micardis® plus under usual daily-practice~     prescribing-conditions~   "
101536|NCT02238262|"~     The aim of the observational study was to supplement the data on efficacy, safety and~     tolerability of telmisartan under daily conditions in hospitals~   "
101537|NCT02238249|"~     Study to investigate the safety and efficacy of Alesion® Dry Syrup under the proper use in~     daily clinical practice in Japanese paediatric patients with urticaria~   "
101538|NCT02238236|"~     Study to investigate the safety and efficacy of Alesion® Dry Syrup under the proper use in~     daily clinical practice in Japanese paediatric patients with allergic rhinitis,~     eczema/dermatitis, urticaria and pruritus~   "
101539|NCT02238223|"~     Study to investigate the safety and efficacy information of Alesion® Tablet under the proper~     use in daily clinical practice after new treatment guideline for allergic rhinitis, bronchial~     asthma, eczema, dermatitis, urticaria, pruritus, prurigo and psoriasis vulgaris with itching~   "
101540|NCT02238210|"~     Study to determine the safety of Atrovent Nasal Spray 0.06% in pediatric patients (ages 2-5~     years) with symptoms of rhinorrhea associated with a naturally occurring common cold or from~     symptoms of rhinorrhea associated with allergies~   "
101541|NCT02238197|"~     To obtain further information on the tolerability and efficacy of Atrovent® 500µg/2ml~     inhalation solution in the treatment of Chronic Obstructive Pulmonary Disease under~     conditions of daily practice~   "
101542|NCT02238184|"~     To obtain further information on the prescribing pattern and therapeutic long term value in~     patients suffering from moderate or severs Chronic Obstructive Pulmonary Disease under~     conditions of daily practice~   "
101543|NCT02238171|"~     To obtain further information on the tolerability and efficacy of Atrovent® inhalets in the~     treatment of Chronic Obstructive Pulmonary Disease under conditions of daily practice~   "
101544|NCT02238158|"~     To obtain further information on the tolerability and efficacy of Atrovent® inhalets in long~     term treatment of Chronic Obstructive Pulmonary Disease under conditions of daily practice~   "
101545|NCT02238145|"~     To obtain further information on the tolerability and efficacy of Atrovent® inhaletten® in~     the treatment of chronic obstructive airways disease under conditions of daily practice~   "
101546|NCT02238132|"~     To obtain further information on the tolerability of Atrovent® inhalets in the treatment of~     Chronic Obstructive Airways Disease under conditions of daily practice~   "
101547|NCT02238119|"~     Study to evaluate the lung function response to the free once-daily combination of tiotropium~     + formoterol compared to formoterol BID and tiotropium QD~   "
101548|NCT02238106|"~     The primary objective of this trial was to establish non-inferiority of lung function~     response to two doses [25 μg (1 capsule) and 50 μg (2 capsules of 25 μg)] salmeterol,~     administered as the xinafoate salt, in an inhalation powder delivered from hard polyethylene~     (PE) capsules via the HandiHaler® 2 compared to Serevent® Diskus® (salmeterol 50 μg,~     administered as the xinafoate salt) following single dose inhalation in patients with COPD. A~     hard capsule with half the strength (12.5 μg) was included to investigate a dose ordering~     effect.~      The secondary objectives were to characterize the pharmacokinetics of salmeterol inhalation~     powder delivered by HandiHaler® 2 from the PE hard capsule(s) and salmeterol xinafoate~     delivered by Serevent® Diskus®, and to compare the safety of the different pharmaceutical~     forms and/or doses.~   "
101549|NCT02238093|"~     Cardiorenal Syndrome (CRS) is prevalent among end-stage renal disease (ESRD) patients.~     Recently, its prevalence is rising. There are several different clinical presentations of~     this syndrome. It has a high rate of morbidity and mortality.~      The purpose of this study is to find the connection between the heart pathology and its~     effect on ESRD patients. This will aid in choosing the appropriate medical therapy for these~     patients, and hopefully, aid in increasing their quality of life, and decrease their~     morbidity and mortality.~   "
101550|NCT02238080|"~     This observational, multi-center, open-label, prospective study will evaluate the~     relationship between serum interleukin-6 (IL-6) and C-reactive protein (CRP) levels and~     methoxy polyethylene glycol-epoetin beta dosage in participants with chronic kidney disease~     (CKD) on dialysis. Participants will be recruited who are on stable methoxy polyethylene~     glycol-epoetin beta maintenance therapy or will initiate therapy with methoxy polyethylene~     glycol-epoetin beta.~   "
101551|NCT02238067|"~     This study is a prospective, non-interventional, cross-sectional multicenter survey. The aim~     is to better understand the current therapy pattern for anemia in CKD treated with~     erythropoiesis-stimulating agents (ESAs) and not on-dialysis participant population in~     Israel. Participating physicians will be requested to interview eligible participants with~     CKD not on dialysis and to complete for them a satisfaction survey for anemia treatment. The~     survey will be completed twice, once at study start and once at six months' follow-up.~   "
101552|NCT02238054|"~     Observational Study, French, prospective, multicenter rated using intravascular prosthesis~     ABSORB BVS.~      ABSORB BVS is a prosthesis of a new type. This study will prospectively evaluate all~     procedures for coronary angioplasty with implantation of at least one BVS with a clinical~     follow-up of all patients implanted with ABSORB BVS. This national observatory will collect~     all the events related to product and / or to procedure~   "
101553|NCT02238041|"~     The primary purpose of this Study is evaluation of the safety and accuracy of the GlucoClear~     CGM System.~   "
101554|NCT02238028|"~     An intervention study to assess the short-term cardiovascular effects of reducing personal~     air pollution exposure by wearing particulate filtering respirators.~   "
101555|NCT02238015|"~     To compare tear film differences between surgical eyes and nonsurgical eyes in patients who~     had cataract surgery by phacoemulsification in one eye.~   "
101556|NCT02238002|"~     To investigate changes in anterior chamber angle configuration after phacoemulsification and~     intraocular lens (IOL) implantation with Swept-Source Optical Coherence Tomography (SS-OCT).~   "
101557|NCT02237989|"~     The aim of this study was to evaluate symptomatic efficacy of native collagen type 2 on joint~     pain and function and its effects on urinary biological markers related to cartilage~     degeneration in patients with knee osteoarthritis.~   "
101558|NCT02237976|"~     The proposed study is designed to utilize a self-hypnosis training program for patients~     awaiting lung transplantation. This technique can increase their well being, particularly by~     decreasing postoperative pain.~   "
101559|NCT02237963|"~     The prevalence of chronic pain after a thoracotomy is around 48 %. This research focuses on~     the surgical approach. The posterolateral approach is compared to the axillary approach~     especially in term of development of a chronic pain.~   "
101560|NCT02237950|"~     A double-blind, phase 3 study to determine the efficacy of SPL7013 Gel when administered on~     alternate days for 16 weeks, compared to placebo gel in preventing the recurrence of BV in~     women with a history of recurrent BV.~   "
101561|NCT02237937|"~     The study evaluates the ABCB1-genotype dependent efficacy of a quick dose-escalation strategy~     within 28 days of treatment with approved antidepressants that are known substrates of the~     P-glycoprotein, an efflux pump of the blood-brain barrier expressed by the ABCB1 gene.~      Moreover, the study evaluates ABCB1-genotype dependent side-effects of approved~     antidepressants that are known substrates of the P-glycoprotein, an efflux pump of the~     blood-brain barrier expressed by the ABCB1 gene.~   "
101562|NCT02237924|"~     A total of 120 patients with pathologically confirmed locally advanced low-risk~     nasopharyngeal carcinoma were enrolled. They were randomly divided into two groups, with 60~     patients in each group. One group was treated with intensity-modulated radiation therapy~     (IMRT) combined with Endostar and the other group was treated with IMRT combined with~     concurrent chemotherapy. The short term efficacy and the toxic and side effects of these~     treatments were evaluated. The 1-year, 3-year, 5-year overall survival and progression-free~     survival of patients were analyzed. Our data may provide an alternative option for the~     treatment of locally advanced low-risk nasopharyngeal carcinoma with high efficacy and low~     toxicity.~   "
101563|NCT02237911|"~     Although total knee replacement (TKR) improves pain in numerous patients, it does not resolve~     many of the substantial functional limitations and physical inactivity that existed for a~     long time prior to the surgery. Exercise is an intervention that could improve these~     long-term limitations. To promote these improvements, exercise should be implemented at later~     stage post TKR when patients can tolerate doses of exercise sufficiently high to promote~     substantial changes. To date, we just don't have enough good research to tell us which type~     of exercise works best for which patients and under which circumstances at later stage post~     TKR. This research study will provide evidence for recommended interventions during the later~     stage post TKR. The specific research questions are: (1) How do group exercise in the~     community and individual exercise in rehabilitation clinic compare with usual medical care on~     physical function and activity outcomes? (2) Who are the patients most likely to respond to~     each exercise intervention? (3) Are the approaches safe?~   "
101565|NCT02237885|"~     Up to half of military veterans with traumatic brain injury (TBI) also suffer from~     co-occurring posttraumatic stress disorder (PTSD). Both are linked to higher risk of chronic~     pain, one of the most common health complaints among U.S. veterans who served in Operation~     Enduring Freedom (Afghanistan), Operation Iraqi Freedom (Iraq), and Operation New Dawn~     (OEF/OIF/OND). However, pain medications elevate risk of opioid abuse, and studies indicate~     that veterans perceive barriers to traditional mental health treatments. Little research~     exists regarding non-pharmacological, technology-based interventions designed to reduce pain~     in veterans with PTSD and TBI. Mobile technology used to implement neurofeedback (EEG~     biofeedback) shows promise in providing a portable, low-cost intervention for reducing pain~     in veterans with co-occurring disorders. We aim to test the feasibility and effectiveness of~     using mobile neurofeedback devices for reducing pain symptoms in veterans with PTSD and TBI.~     Veterans with PTSD, TBI, and chronic pain will receive a NeuroSky headset (which reads EEG~     brain waves) and an iPod Touch with an app called Mobile Neurofeedback (which provides~     neurofeedback to induce relaxation). Veterans are taught how to use these together to do~     neurofeedback themselves at home for 12 weeks. Guided by existing research and preliminary~     data, we hypothesize that participants will show high levels of adherence to the NeuroSky +~     Mobile Neurofeedback intervention for the 3-month study duration and that participants will~     show statistically significant reduction in pain symptoms at 3 months compared to baseline.~     Given links between pain and other outcomes in veterans, we will also explore effects on drug~     abuse, violence, and suicidality. When the research is complete, the field will be changed~     because we will know whether new technology reading EEG brainwaves can be used to treat~     symptoms among individuals suffering from chronic pain. We will also know whether~     neurofeedback shows promise as an effective intervention for veterans with PTSD and TBI to~     reduce pain and related outcomes. If this program of research is successful, its impact will~     be to shift approaches to managing pain in clinical practice, for both veterans and civilians~   "
101566|NCT02237872|"~     The primary goal of this study is to assess the accuracy of conventional fat fraction proton~     MRI for the detection of Brown Adipose Tissue (BAT) in healthy subjects using FDG-PET as gold~     standard.~      In this pilot study, MRI and PET imaging of BAT of healthy adult volunteers will be performed~     on a combined PET/MRI scanner under mild cold condition.~   "
101567|NCT02237859|"~     We are doing this research study to determine if taking vancomycin in addition to a~     broad-spectrum antibiotic will decrease the chance of developing recurrent Clostridium~     difficile infection.~   "
101568|NCT02237846|"~     Allogeneic human umbilical cord tissue-derived stem cells injected intravenously (IV) once~     per day for 3 days or once intra-articularly are a safe and will induce a therapeutic effect~     in osteoarthritis (OA) patients.~   "
101569|NCT02237833|"~     The purpose of this study is to reveal if higher doses of vasopressors in septic shock~     patients correlates with cerebral vasoconstriction and lower cerebral oximetry.~   "
101570|NCT02237820|"~     This is the first study assessing the impact of dexamethasone (a glucocorticosteroid with~     negligible mineralocorticoid activity) as compared to prednisone on short-term outcomes of HF~     patients hospitalized with exacerbation of COPD. The study may provide important data~     regarding a simple but potentially robust intervention among large patient population with~     high rates of hospital admissions.~   "
101571|NCT02237807|"~     The purpose of this study is to assess the bioequivalence of the investigational TEST product~     with the marketed REFERENCE products by measurement of Plasma concentrations of~     Erythromycylamine in plasma and calculation of the bioequivalence parameters from those~     measurements followed by ANOVA and 90% confidence interval statistical evaluation.~   "
101572|NCT02237794|"~     The purpose of this study is to determine the effect of medical treatment on longitudinal~     myocardial function. Patients who have been hospitalized for reasons other than heart disease~     will be examined with Transthoracic Cardiography before and after medical treatment to~     determine change in myocardial function.~   "
101573|NCT02237781|"~     Anti-Mullerian Hormone (AMH) is produced only in small ovarian follicles with quite stable~     levels during the cycle. There is not yet sufficient data to inform couples undergoing IVF~     about the effect of ovarian stimulation on the levels of AMH due to the increasing size of~     follicles and chances of success of the method.~   "
101574|NCT02237768|"~     The purpose of this study is to assess the bioequivalence of the investigational TEST product~     with the marketed REFERENCE products by measurement of Plasma concentrations of~     Erythromycylamine and calculation of the bioequivalence parameters from those measurements~     followed by ANOVA and 90% confidence interval statistical evaluation.~   "
101575|NCT02237755|"~     Coadministration of various drugs used for ovarian stimulation can increase the efficiency of~     IVF especially in poor responders. The investigators hypothesize that ovarian response of~     those patients could improve by using combination of clomiphene citrate with gonadotropins in~     infertile women with poor response to gonadotrophin administration only.~   "
101576|NCT02237742|"~     To determine how the body reacts to a low dose of PF‑06427878 when given in a vein over 30~     minutes to healthy, adult, males.~   "
101577|NCT02237729|"~     This is a Phase 1, double blind (sponsor open), randomized (1:1:1), parallel group, 3 arm,~     single dose comparative PK study of adalimumab Pfizer and adalimumab sourced from the US and~     EU administered subcutaneously (SC) to healthy male and female volunteers~   "
101578|NCT02237716|"~     The purpose of this study is to observe the variation of Hemodynamics、lactic acid、base~     excess、peripheral vascular resistance and DO2 through FloTrac™/Vigileo™ system after rapid~     infusion mannitol in neurosurgery.The hemodynamic changes after mannitol infusion are shown~     in Figure 1. HR (Fig. 1A) and systolic BP (Figure 1B) significantly increased between 0 min~     and 10 min (P = 0.041) and between -10 min and 10 min (P = 0.073), respectively; these two~     variables decreased steadily and returned to the baseline. Diastolic BP (Fig. 1B) showed no~     significant change after mannitol infusion (P = 0.102). CVP (Fig. 1C) significantly increased~     between -20 min and 0 min (P < 0.001) and constantly decreased after 0 min, which remained~     below the baseline between 30 min and 60 min. CI (Fig. 1D) and SVI (Fig. 1E) showed a~     significant persistent increase between -20 min to 0 min (P < 0.001) and between -20 min and~     10 min (P < 0.001), respectively. SVV exhibited a dipper-type change shown as a significant~     decrease between -20 min and 0 min and a significant increase between 0 min and 60 min (P <~     0.001), which returned to the baseline after 20 min.~   "
101589|NCT02237573|"~     In France, patients with benign viral infections (ie: gastro enteritis and/or~     rhinopharyngitis, etc.) often receive several prescriptions from their doctors, although~     there is evidence that these medicines are not efficient.~      We hypothesize that patients could be reassured by health advices, especially if they are~     written. In addition, we believe that doctors would feel less guilty for not prescribing~     drugs if they could hand written consultation reports to patients, in these situations.~      We aim to assess the impact of handing to patients with viral gastroenteritis or upper~     respiratory tract infections, a copy of the consultation report on their medicine~     consumption.~   "
101579|NCT02237703|"~     This study uses positron emission tomography (PET) imaging to measure kappa opioid receptors~     (KOR) in the brains of individuals with and without post-traumatic stress disorder (PTSD).~     The investigators propose to recruit 45 drug-naïve individuals, N=15 patients with PTSD, N=15~     trauma-exposed, but asymptomatic healthy control subjects (TC) and N=15 non-trauma exposed~     healthy control subjects (HC) to participate in one magnetic resonance imaging (MRI) and one~     PET study. The investigators will also carefully document trauma history, and collect~     behavioral and neuroendocrine measures to provide a more integrative view on the neurobiology~     of PTSD and its phenotype. The investigators predict PTSD will show greater carbon - 11~     (11C)[11C]LY2795050 volume of distribution (VT) (i.e. KOR binding) values than control~     populations in an a priori defined PTSD circuit.~   "
101580|NCT02237690|"~     This is a multi-center, single-dose, open-label, randomized, balanced, two-treatment,~     two-cycle, two-sequence crossover study to assess bioequivalence of test (T) and reference~     (R) formulations of doxorubicin hydrochloride liposome injection in female patients with~     ovarian cancer.~      Each patient will be randomized to one of two treatment sequences (RT or TR) according to a~     randomization scheme prepared prior to the start of the trial.There will be at least 4-week~     apart between each single-dose administration. Serial blood samples for determination of free~     doxorubicin and liposomal encapsulated doxorubicin plasma concentrations for PK analysis will~     be obtained in each cycle.~      The 90% confidence intervals on the GMR(geometric mean ratio) of test to reference products~     of free and liposome encapsulated doxorubicin for PK must be within 80-125% to demonstrate~     bioequivalence.~   "
101581|NCT02237677|"~     The objective of the proposed translational study is to test a model, based upon basic~     science studies, exploring multisystem impairments in PTSD including endocannabinoid (eCB)~     and glucocorticoids in the modulation of fear memories by examining the cannabinoid type 1~     (CB1) receptor in a PTSD fear circuit as well as glucocorticoid function. The investigators~     propose that impaired eCB signaling in PTSD resulting in the maladaptive neurobehavioral~     response to the stressor is associated with an upregulation of the CB1 receptors and~     insufficient glucocorticoid signaling.~   "
101582|NCT02237664|"~     Thoracic surgery is commonly associated with severe postoperative pain and marked impairment~     of respiratory function.1 Minimally invasive video-assisted thoracic surgery (VATS) is~     assumed to result in better quality of life and less postoperative pain compared with~     standard open thoracotomy, other investigators have reported comparable patient-reported~     physical component summary and pain scores after VATS and thoracotomy during the first 12~     months after lung resection.2 That study was non-randomized and 41% of the included patients~     did not complete the follow-up period.2 VATS has recently been increasing in popularity as a~     fast-track surgery with potential enhanced recovery after surgery.~      Variety of approaches exist to manage pain after thoracotomy which could attenuate~     post-thoracotomy pulmonary dysfunction. Epidural analgesia has been considered for many~     decades to be the best method of pain relief after major thoracic surgery. In previous~     meta-analyses,3-5 many investigators have reported that thoracic paravertebral blockade (PVB)~     has comparable analgesic effects to thoracic epidural analgesia (TEA) in patients undergoing~     thoracotomy.~      Additionally, PVB has a better side-effect profile, lower rates of failed block and is~     associated with a reduction in pulmonary complications.3-5 This could be extended to VATS to~     enhance recovery after surgery owing to effective analgesia and fewer side effects.6-7~      Patient-controlled analgesia (PCA) has been advocated as a favourable model for postoperative~     analgesia, that allows a perfect match between intensity of pain and analgesic delivery,~     improves the quality of analgesia and decreases the cumulative analgesic consumption.~     Furthermore, the introduction of patient-controlled epidural analgesia (PCEA) with background~     infusion during labour gave patients a sense of control over their analgesia, reduced the~     total dose of local anesthetic administered, and had less motor block than those who receive~     continuous epidural analgesia.8-9Patient-controlled epidural analgesia (PCEA) has become~     increasingly popular for pain control after thoracotomy.10-12 In a previous preliminary~     study, McElwain et al.13 have reported satisfactory analgesia after breast cancer surgery~     with the use of PC-PVB, using either 15-min or 30-min lockout, that study did not include a~     comparative arm with a continuous paravertebral infusion. Furthermore, Abou Zeid et al. have~     reported comparable analgesia after thoracic surgery with the use of either~     patient-controlled PVB had with the use of intrathecal morphine, that study was not~     controlled and included few patients.14~      The efficacy of the patient-controlled paravertebral blockade (PC-PVB) on the quality of~     postoperative analgesia and pulmonary function after VATS has not yet been studied.~   "
101583|NCT02237651|"~     The primary aim of this study is to compare a simplified single-use product (LMA® MAD Nasal™~     Intranasal Mucosal Atomization Device, Teleflex medical, Kernen Germany) for topical~     nasopharyngeal anesthesia in comparison to a multi-use device (Laryngeal atomizer, Karl~     Storz, Tuttlingen, Germany in terms of patient self-rated nasopharyngeal symptoms.~   "
101584|NCT02237638|"~     The primary objectives of this study are to investigate the safety and tolerability profile~     of the therapeutic vaccine hVEGF26-104/RFASE and to determine the effective dose of~     hVEGF26-104/RFASE required to neutralize VEGF in serum, defined as a VEGF level below 9,0~     pg/mL.~   "
101585|NCT02237625|"~     Hypophosphatasia (HPP) is a rare inherited metabolic disorder characterized by defective bone~     and teeth mineralization caused by mutations of the ALPL gene, which encodes for the~     tissue-nonspecific alkaline phosphatase (TNSALP) isozyme, resulting in decreased serum and~     bone alkaline phosphatase levels. To date, over 250 different mutations in the gene encoding~     TNSALP have been associated with HPP. Clinically, the loss of TNSALP function results in~     progressive skeletal impact as well as progressive impact on all other major organ systems.~     It clinically manifests as rickets in infants and children and osteomalacia at all ages. The~     severe form of the disease has been estimated to have a prevalence of about 1 in every~     100,000 live births.~   "
101586|NCT02237612|"~     This pilot clinical trial studies how well diffusion-weighted magnetic resonance imaging~     (MRI) works in staging patients with prostate cancer that has not spread to nearby lymph~     nodes or other parts of the body. New imaging techniques, such as diffusion-weighted MRI, may~     be a less invasive way of predicting the stage and grade of prostate cancer.~   "
101587|NCT02237599|"~     This study hypothesizes that an automated device using small electronic impulses can detect~     nerve impairment in unconscious patients.~   "
101588|NCT02237586|"~     The study is designed to establish infectivity of Plasmodium falciparum sporozoites (PfSPZ)~     via intravenous (IV) administration in three groups with different malaria immunity-status:~        1. Adults with a history of lifelong malaria exposure without sickle cell trait (HbAA)~        2. Adults with a history of lifelong malaria exposure with sickle cell trait (HbAS)~        3. Adults without previous malaria episodes without sickle cell trait (HbAA)~      Initially a dose of 3,200 PfSPZ will be given and the time until thick blood smear positivity~     after challenge will be assessed. If in any of the groups with a history of lifelong malaria~     exposure, 50% or less of individuals become thick blood smear positive during the 28 days~     post injection of PfSPZ Challenge, the dose will be increased 4-fold to 12,800 PfSPZ in this~     group.~   "
101684|NCT02236338|"~     The aim of this study is to perform a randomized, prospective trial comparing the two current~     methods of treatment for chronic venous insufficiency, in an effort to evaluate complications~     and outcomes for each method, and ultimately, to see if one is superior to the other.~   "
101590|NCT02237560|"~     The purpose of this study is to clarify the benefits to brain health and thinking processes~     that result from different forms of exercise. This study will examine the effectiveness of~     cybercycling (virtual reality enhanced stationary cycling) for persons at risk for and with~     MCI, and compare this with the individual cognitive, behavioral, and physiological effects of~     physical and mental exercise alone. The Investigators hypothesis that cognitive benefit will~     be greatest for combined aerobic and cognitive exercise compared to physical and mental~     exercise alone.~   "
101591|NCT02237547|"~     Human Umbilical Cord-derived Mesenchymal Stem Cells (UC-MSC) and Bone Marrow Mononuclear~     Cells (BMMC) from the patient injected into the spinal fluid intrathecally and injected~     intravenously (IV) is a safe and therapeutic procedure for spinal cord injury (SCI) patients.~   "
101592|NCT02237534|"~     The purpose of this study is to compare the effect of lanthanum carbonate and calcium~     carbonate on the progression of coronary calcification and vascular endothelial dysfunction.~   "
101593|NCT02237521|"~     Patients with end-stage renal disease (ESRD) have a high prevalence of impaired glucose~     metabolism. The pathophysiological cause is uncertain, but disturbances in the secretion,~     elimination and effect of glucagon, insulin and the two incretin hormones glucagon-like~     peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), probably play~     important roles. Our research group has previously found that dialysis patients without type~     2 diabetes mellitus (T2DM) have a reduced incretin effect and an inability to suppress~     glucagon after a meal - two early pathophysiological characteristics of patients with T2DM~     and normal kidney function.~      The aim of the project is to provide a detailed description of the mechanisms underlying the~     (patho)physiological effects of the incretin hormones in patients with ESRD. We plan to~     investigate the above mentioned disturbances during fasting and hyperglycaemic conditions~     using incretin infusions during glucose clamping. Furthermore, stable isotopic tracers will~     be used to determine the effect of the incretin hormones on the endogenous glucose handling.~      We hypothesise that the effects of the incretin hormones in ESRD will be reduced in respect~     to healthy control subjects.~   "
101594|NCT02237508|"~     The pharmacokinetics study aims to evaluate the safety of Z7200 (budesonide/formoterol) in~     comparison with Symbicort Turbohaler (budesonide/formoterol), assessing the bioequivalence of~     the two products. Namely the study will compare the total systemic bioavailability (as an~     indicator of safety), and it will compare the pulmonary bioavailability (as a possible~     surrogate indicator of efficacy). This study will be performed in healthy subjects.~   "
101595|NCT02237495|"~     Cardiac surgery is associated with a high risk of cardiovascular and other complications. The~     investigators hypothesized that perioperative infusion of dexmedetomidine may reduce the~     incidence of complications and mortality following cardiovascular surgery.~   "
101596|NCT02237482|"~     This study is intended to compare the proximal migration of the tantalum design (TM) with a~     cemented cup used in conjunction with bone allografting in cases with major bone loss. A~     group of patients with good periacetabular bone stock are included to analyse the differences~     between the tantalum and titanium design regarding risk of loosening and differences in~     clinical outcome measures. Radiostereometry (RSA) is used to accurately measure migration and~     rotation of the revision cups.~   "
101597|NCT02237469|"~     The study purpose is to evaluate whether or not clinical characteristics of women with breast~     cancer can predict which position for radiation treatment, prone or supine, will be~     associated with a dosimetry gain. Dosimetry gain in this study means the lowest radiation~     dose to non-target organs (heart, lungs, contralateral breast), while giving the prescribed~     dose to tumor bed and ipsilateral breast.~   "
101598|NCT02237456|"~     The purpose of this study is to compare optical coherence tomography (OCT) scans performed in~     the same coronary artery with two different OCT systems (Lunawave and OPTIS) before and after~     implantation of stents or bioresorbable scaffolds.~   "
101599|NCT02237443|"~     Anesthesia providers are taught to test that they can properly ventilate a patient's lungs~     before administering a neuromuscular blocking drug (NMBD), rendering the patient apneic. This~     is a traditional teaching, not based on empirical evidence. The investigators primary~     hypothesis is that ventilation after the administration of NMBDs is non-inferior with that~     before their administration with respect to the composite safety endpoint of inadequate (MVi)~     and dead-space only (Vds) ventilation.~   "
101600|NCT02237430|"~     Is the MynxGrip (test device) non-inferior to manuel compression (standard comparator) in the~     incidence of adverse access site related events in-hospital, at 30 days and at 6 months.~   "
101601|NCT02237417|"~     This is a Phase 4, randomized, open-label, parallel group study designed to assess the~     clinical and biological effects of 12 months of treatment with long acting intramuscular (IM)~     aripiprazole (Abilify®) as measured by clinical and behavioral measures, and changes on~     magnetic resonance imaging (MRI) scans in subjects with schizophrenia compared with SOC oral~     antipsychotic medications and compared with a healthy control group.~      It is hypothesized that improved treatment compliance will lead to fewer white matter changes~     in the brain. Fewer white matter changes will be demonstrated via neuroimaging as increased~     FA and BPF values in the prefrontal region, and an increase in metabolites in a voxel~     centered on the anterior cingulate cortex (ACC) as seen with MRS. Therefore, the aim of this~     study is to examine the structural and metabolic effects of aripiprazole (Abilify®) once~     monthly in patients with schizophrenia using MRI techniques and to examine these effects in~     association with cognitive and clinical measures.~   "
101602|NCT02237404|"~     The purpose of this research is to estimate the outcomes in health and cost of the follow-up~     of patients with pacemakers.~      The initial hypothesize of this study is that remote monitoring of pacemaker will show a best~     relation of outcomes in costs and effectiveness than the conventional follow-up in hospital.~   "
101625|NCT02237105|"~     This study is designed to examine the efficacy of Cognitive Behavioral Therapy (CBT) on the~     outcome of spinal surgery.~      The goal of this treatment is to change the coping style, thoughts, behavior and adaptive~     perception of the patient, and to replace them with an adaptive style.~      The patients in this study will be randomly divided into two groups. One group will undergo~     Cognitive Behavioral Therapy (CBT) before having spinal surgery. The other group will be a~     control group, and will not have any psychological intervention.~   "
113559|NCT02081027|"~     Determine if riluzole shows evidence of efficacy, safety, and tolerability targeting~     drug-refractory irritability (DRI) in persons with autism spectrum disorders (ASD).~   "
101603|NCT02237391|"~     While significant advances in pain management have occurred in the last 20 years, the~     majority of patients with chronic pain (CP) are unable to access evidence-based treatment at~     either the primary or tertiary care level.~      Moreover, research has shown that unrelieved CP and the lack of available expertise~     contribute to emergency department (ED) visits and hospital admissions. At The Ottawa~     Hospital (TOH), close to 18,000 ED visits per year are related to CP (12.9%). Among high~     frequency visitors (HFV; >= 8 visits per year), a small number of patients with CP use an~     inordinate amount of acute care resources. The investigators study will use a randomized~     controlled (RCT) design to conduct a pilot evaluation of the impact of a Complex~     Interdisciplinary Pain Assessment Program (CIPAP) linked with primary care physicians (PCP)~     compared to a treatment as usual (TAU) control arm.~      The investigators hypothesis is that implementing a CIPAP will increase health care value~     through improved patient outcomes and reduced costs in HFV with chronic pain (CP-HFV). The~     investigators believe that a CIPAP will provide CP-HFV patients long-term pain management~     solutions, ED visits for CP will be reduced, and hospital admissions for CP will be~     prevented. This pilot RCT study will inform a larger-scale RCT study to be conducted in the~     future.~   "
101604|NCT02237378|"~     Right ventricular (RV) failure is the leading cause of death in pulmonary arterial~     hypertension. (PAH) Right ventricular ejection fraction is one of the most important~     predictors of prognosis in heart failure patients regardless of cause. It is estimated that~     30-50% of patients with heart failure and preserved ejection fraction (HFpEF) have right~     ventricular dysfunction and up to 70% of these patients will have significant pulmonary~     hypertension (PH), both of which are related to much worse prognosis. Right ventricular~     failure is becoming an increasingly prevalent and significant cause of morbidity in patients~     with left heart disease. Despite the significance of RV function to survival, there are no~     therapies available that directly or selectively improve RV function.~      The overall theme of this research project is to evaluate the mechanisms that contribute to~     the cause of right heart failure. This small study is designed to look at the role of heart~     and lung metabolism and pulmonary hypertension as they relate to the development of right~     heart failure in cardiovascular disease.(PH-LHD)~   "
101605|NCT02237365|"~     Tuberculous meningitis is a severe brain infection which often causes disability and death~     even when treated with the best available treatment. Aspirin is a type of anti-inflammation~     drug which can reduce the inflammatory response in brains of patients with tuberculous~     meningitis, and therefore may decrease some of the most severe outcomes. This study compares~     the use of aspirin (at 2 different doses) versus placebo as an additional therapy to the~     standard treatment to see if aspirin is safe and helpful in reducing disability and death~     from tuberculous meningitis. Patients will be treated with aspirin or placebo for 60 days and~     followed up while on standard treatment for 8 months.~   "
101606|NCT02237352|"~     The prevalence of diabetes mellitus (DM) is increasing worldwide, suggesting that 45% of~     diabetics are undiagnosed. DM induces a kidney disease called diabetic nephropathy (DN) which~     is the largest single cause of end-stage renal disease and dialysis requirement. In South~     America the prevalence of DM and chronic kidney disease has increased, and great disparity~     exists among countries in regards to access to the dialysis treatment. It has been~     considerate that Hispanic origin increases the risk for DM. The South Americans have~     distinctive habits, culture, environment, behavior and genetic background and the factors~     involved in DN have not been defined yet. The early kidney lesions such as neoangiogenesis~     (pathologic generation of the new blood vessels) and extracellular matrix expansion have been~     described. The vascular endothelial growth factor A (VEGF) has been linked to angiogenesis,~     but the role of VEGF in DN has not been elucidated yet. VEGF signals mainly through VEGF~     receptor 2 (VEGFR2). VEGFR2 interacts with alphaV beta3 integrin (AVB3) in kidney.~     Additionally tenascin C is expressed in the extracellular matrix. Tenascin C and the tenascin~     C/AVB3 complex have also been linked to angiogenesis, however their roles have not been~     unveiled yet in the DN. Investigators hypothesize that VEGF signaling and tenascin C play an~     important role in DN and that VEGFR2, AVB3 and tenascin C interact. The purposes of this~     study is to characterize social, environmental and biological factors implicated in the DN in~     Ecuador and define the role of VEGF signaling and tenascin C in the pathogenesis of the DN.~     Investigators propose to study factors involved in DN in diabetic and non-diabetic adults~     from general population, with and without DN. In a single time investigators will evaluate~     demographics data, habits, personal and family history through a survey. Investigators will~     measure anthropometrics parameters and blood pressure; investigators will quantify blood~     glucose, glycosylated hemoglobin A1c and proteinuria. In addition investigators will examine~     the role of tenascin C and VEGF signaling by analyzing paraffin embedded kidney tissue,~     plasma and urine samples. Characterizing the factors involved in the DN from Hispanic people~     is key to establish adequate strategies of prevention, diagnosis and treatment in this~     population. Furthermore elucidating the role of proteins involved in DN may offer valuable~     tools for the development of new treatments.~   "
101607|NCT02237339|"~     The presence of Left ventricular hypertrophy (LVH) confers high cardiovascular risk in~     hypertensive patients. LVH remains highly prevalent even when blood pressure (BP) is~     controlled. There is increasing evidence that a major non-haemodynamic contributor to LVH is~     oxidative stress. Allopurinol is known to markedly reduce oxidative stress.~      This pragmatic randomised double blind placebo controlled trial will examine whether~     allopurinol (300 mg bd) regresses LV mass as assessed by cardiac magnetic resonance (CMR) in~     66 patients with treated hypertension but who have persisting LVH.~      Endothelial and vascular function will also be assessed via flow mediated dilatation (FMD)~     and pulse wave analysis respectively (PWA) and plasma biomarkers of oxidative stress will be~     measured. The treatment (allopurinol or placebo) will last 12 months.~   "
101608|NCT02237326|"~     The clinical trial is part of a larger study to evaluate the safety and efficacy of screening~     techniques for cervical cancer among HIV-infected women. The investigators randomized women~     to undergo screening with Visual Inspection with Acetic Acid (VIA) or Visual Inspection with~     Lugol's Iodine (VILI), along with a colposcopy. All outcome and treatment decisions were~     based on the colposcopy exam done at the study visit. The investigators then compared~     outcomes between the two groups to assess the test characteristics of both VIA and VILI.~   "
101609|NCT02237313|"~     The bullous pemphigoid treatment is based on corticosteroids continued for several years.~     Pemphigus causes some patients a psychological impact and sometimes major vulnerability that~     can occur not only at diagnosis but also at later stages of disease progression. Our~     hypothesis is that these episodes of vulnerability may be under four kinds of factors that~     may be connected to the plurality of the history of these patients, and the resources they~     can mobilize throughout this experience, generating inequality in management and work~     around the disease.~   "
101626|NCT02237092|"~     It is known that an increase in intra-abdominal pressure (IAP) causes a decrease in the~     volume of cerebrospinal fluid in the lumbar and lower thoracic region, which may contribute~     to the development of more high spinal block.~   "
102726|NCT02222740|"~     Assess the safety, tolerability and pharmacokinetics of multiple doses of 10, 20, 30, and 40~     mg of Hydrocodone Bitartrate Extended Release (HC-ER)capsules taken with food at steady~     state, in subjects with chronic, moderate to severe osteoarthritis (OA) pain.~   "
101610|NCT02237300|"~     Introduction: The purpose of this research is to develop a new component for~     cognitive-behavioral treatment (CBT), empirically validated, for binge eating behavior in~     patients with bulimia nervosa (BN) and binge eating disorder (BED), by means of cue-exposure~     therapy (CET) with virtual reality. While CBT is an effective treatment for these eating~     disorders, an important percentage of patients do not improve despite treatment. It is~     necessary to explore how to enhance the effectivity of usual treatments with the~     incorporation of new technologies and procedures. The innovation of this investigation is~     based on the use of VR for cue-exposure therapy, which has been found effective with patients~     resistant to conventional treatments (CBT and pharmacological intervention), and seeks to~     enhance this efficacy by increasing possibilities of generalization and providing more useful~     tools to clinicians, diminishing the logistic complications of the exposure to real cues~     (food).~      Participants: 60 patients with a diagnosis of BN or BED according the DSM-5 who had been~     proposed for participation in the study by their referral mental health's professional after~     conducting unsuccessfully a first level treatment (CBT structured intervention) at the~     clinical sites involved will participate in the study.~      Procedure: Participants with active episodes of binge eating (and purging, in the case of BN)~     during the last 2 weeks of the structured intervention of CBT will be provided with detailed~     information about the study. All patients who agree to participate in the study and who sign~     the informed consent form will be randomly assigned to one of the two second-level treatment~     conditions: virtual reality based cue-exposure therapy (VR-CET) or additional~     cognitive-behavioral treatment (A-CBT). Both second-level treatment conditions consist of six~     60-minute sessions that are held two times per week over a period of three weeks.~      In an interview setting, all of the participants will be administered several questionnaires~     (BN, DT and BD subscales of EDI-3, FCQ-T/S, and STAI-Y) and participants assigned to the~     VR-CET will also be exposed to various types of virtual foods in different virtual~     environments (kitchen, dining-room, bedroom, and café) where they will be asked about their~     food cravings and anxiety experienced in each situation to develop a proper exposure~     hierarchy according to the specific characteristics and needs of each patient.~   "
101611|NCT02237287|"~     Background: The wound healing promoting effect of negative wound pressure therapies (NWPT)~     takes place at the wound foam interface. Implementation of bioactive substances at this site~     represents a major research area for the development of future NWPT devices.~      Methods: Wound healing kinetics of pressure ulcers treated by vacuum assisted closure devices~     with or without the implementation of a thin interface of poly-N-acetyl glucosamine~     nanofibers (sNAG) was studied in a prospective randomized clinical trial.~   "
101612|NCT02237274|"~     Important advances in cardiac surgery, intensive care, and diagnostic modalities over the~     last decades have led to a steady growth in the number of adults with congenital heart~     defects. Among adults with congenital heart disease, patients with a Fontan circulation~     typically show the lowest values of peak oxygen consumption. For these patients, strict~     exclusion from activities at high altitude may have an impact on quality of life. The~     investigators aim to elucidate the short term effects of a stay at high altitude on~     hemodynamic adaptation, exercise capacity and clinical well being in adult Fontan patients.~     The investigators hypothesize that patients with a Fontan circulation in NYHA functional~     class I-II are able to increase their cardiac output during exercise at high altitude in~     order to meet the required metabolic demands and therefore tolerate the journey to the~     Jungfraujoch well.~   "
101613|NCT02237261|"~     The purpose of this study is to improve efficacy of treatment for patients with newly~     diagnosed multiple myeloma who are not eligible for high-dose chemotherapy followed by~     autologous stem cell transplantation by Bendamustin, Bortezomib (Velcade), and Prednisone.~   "
101614|NCT02237248|"~     The purpose of the study is to examine the changes in function and performance biomechanics~     in patients undergoing spinal fusion corrective surgery for adolescent idiopathic scoliosis~     (AIS).~   "
101615|NCT02237235|"~     The goals of this study are to study MMFS-202-302 in a double blind, randomized,~     placebo-controlled 9-week study of its effect on ameliorating cognitive deficits in 60~     patients with schizophrenia or schizoaffective disorder with stable levels of positive~     symptoms. Secondary end points will include changes in positive and negative symptoms. One~     dose of MMFS-202-302 will be studied and compared with placebo as adjunctive treatment to~     atypical antipsychotic drug treatment.~   "
101616|NCT02237222|"~     The aims of this project are to evaluate the psychometric properties of the German versions~     of the two performance questionnaires 'Functional Mobility Scale' (FMS) and 'Gillette~     Functional Assessment Questionnaire - walking scale' (GFAQ) in children between 6-18 years~     with a neuromuscular diagnosis.~   "
101617|NCT02237209|"~     Respiratory syncytial virus (RSV) is a common cause of illness in infants and children around~     the world. This study will evaluate the safety and immune response to an RSV vaccine in~     RSV-seronegative infants and children.~      This study is a companion study to CIR 291.~   "
101618|NCT02237196|"~     This trial will test whether a novel therapeutic approach, cat immunotherapy combined with an~     investigational new drug called MEDI9929/AMG 157 (an anti-TSLP [thymic stromal lymphopoietin]~     antibody being co-developed by Amgen and MedImmune) can lead to lasting tolerance to cat~     allergen.The objective of the study is to determine whether one year of immunotherapy~     combined with MEDI9929/AMG 157 can induce tolerance to cat allergen.~   "
101619|NCT02237183|"~     This randomized phase I trial studies the side effects and best dose of iloprost compared~     with a placebo in preventing lung cancer in former smokers. Chemoprevention is the use of~     drugs to keep cancer from forming or coming back. Inhaled iloprost may help prevent lung~     cancer from forming in patients who used to smoke and who have been found to have abnormal~     cells in their mucus.~   "
101620|NCT02237170|"~     The purpose of this protocol is perform comprehensive immune monitoring studies in patients~     with castration-resistant prostate cancer receiving Sipuleucel-T in an effort to better~     understand the mechanism of action of this treatment.~   "
101621|NCT02237157|"~     A dose escalation, safety study of local (intra-arterially) delivered gemcitabine to the~     pancreas using the RenovoCath R120 catheter to determine the maximum tolerated dose.~   "
101622|NCT02237144|"~     This is a randomized control trial in two zones of Bangladesh (north and south). Treatment is~     assigned at the village level where treatments are: cash transfers (north and south); cash~     transfers + nutrition behavior communication change (north only); food transfers (north and~     south); food transfers + nutrition behavior communication change (south only); food-cash~     split (north and south); and controls (north and south). Within treatment localities, women~     living in very poor households are targeted to receive benefits for two years.~   "
101623|NCT02237131|"~     To evaluate the efficacy of oral contraceptives in a continuous fashion versus the usual~     cyclic fashion in the recurrence of endometriosis related symptoms and endometriomas~     following fertility-sparing surgery.~   "
101624|NCT02237118|"~     To compare the effects of pain of the two dressings, Mepitel® One and UrgoTul® in acute wound~     management.~   "
107430|NCT02161211|"~     The purpose of this study is to establish a brief CBT intervention that can largely, if not~     fully eliminate the deleterious effect of common co-occurring anxiety disorders on alcohol~     use disorder treatment outcomes.~   "
101628|NCT02237066|"~     The purpose of this study is to compare the Chocolate PTA Balloon to standard Percutaneous~     Transluminal Angioplasty (PTA) catheters. The investigators will use Optical Coherence~     Tomography (OCT) and Quantitative Vascular Angiography to evaluate the acute vascular~     response of vessels treated with the Chocolate Balloon to a standard balloon catheter, with~     the primary endpoint being luminal gain assessed by OCT lumen volume measurements.~   "
101629|NCT02237053|"~     The purpose of this study is to collect data to help researchers better understand the~     effects of glucagon on the amount of calories burned.~   "
101630|NCT02237040|"~     This study aim to evaluate the clinical and radiographic outcomes of mandibular condylar~     fractures in pediatrics treated simply with a mandibular manipulation technique accompanied~     by mouth opening training.~   "
101631|NCT02237027|"~     In the last few years, early treatment of HIV-infected individuals, or treatment as~     prevention (TasP), and pre-exposure prophylaxis with antiretroviral drugs among HIV-negative~     people at very high-risk of acquiring the infection (PrEP) have emerged as highly promising~     biological preventive interventions to tackle the HIV pandemic within the framework of~     combination prevention, a multi-component strategy that has been promoted for the last five~     years. In West Africa, the evidence strongly suggests that female sex workers (FSWs)~     contribute very disproportionally to the HIV spread. This is why the investigators propose~     this TasP and PrEP demonstration project in Benin, where our group has been involved in HIV~     prevention research in the sex work milieu for the last two decades.~      After a run-in phase for community preparedness and the development of a specific education~     program on adherence, the investigators plan to recruit 100 HIV-infected FSWs in the TasP~     component of the project (these women will receive a first-line antiretroviral treatment~     (ART) regimen as per the Benin guidelines) and 250 HIV-negative FSWs in the PrEP component~     (these women will receive Truvada®). The recruitment period will last for one year, followed~     by an additional one year of follow-up, for a total follow-up period varying between 12 and~     24 months, depending on when a given woman is recruited in the study. During follow-up visits~     every three months, the investigators will closely monitor treatment adherence and changes in~     sexual behaviour, including the use of viral load testing among TasP participants and~     Truvada® plasma level testing for PrEP participants, as well as detection of~     prostate-specific antigen (PSA) and Y-chromosome DNA in vaginal fluids in all participants.~      The investigators will evaluate the feasibility of TasP and PrEP through a set of indicators,~     including uptake, coverage, adherence, condom migration, occurrence of side effects and~     development of drug resistance, whereas mathematical modeling will be used to predict the~     potential impact of both interventions in the sex work milieu and the general population,~     based on the actual set of indicators observed. The study will be completed by an economic~     evaluation of the interventions and a cost-effectiveness analysis.~      Finally, the investigators will disseminate the results to the study population and to the~     Beninese health authorities and ensure the broad implementation of these interventions in~     Benin if the demonstration project shows that they are feasible and relevant.~   "
101632|NCT02237014|"~     Peripheral pulse oximetry allows continuous non-invasive measurement of arterial oxygen~     saturation, but the gold standard for arterial oxygen saturation is co-oximeter which~     requires an arterial blood sample. The purpose of this research study is to determine the~     accuracy of a pulse oximeter with a standard sensor (Masimo LNCS sensor) versus with the~     study sensors, namely Masimo blue sensor and Nellcor Max-I sensors and compared against~     co-oximetry. Currently available peripheral oximeters (standard) are inaccurate at low oxygen~     saturation noted in children with cyanotic heart disease. Hence therapeutic interventions~     (including surgery and cardiac catheterizations) based solely on peripheral oximetry can be~     delayed and or inadequate. By doing this study the investigators will be able to establish~     correct limits of peripheral pulse oximeter when using the standard and the study sensors.~   "
101633|NCT02237001|"~     Horizontal meniscus tears meeting specified criteria will be repaired by any commonly used~     suture technique. Subjects will be followed for 2 years to evaluate the effectiveness of the~     repair, by assessing the re-operation rate, and by assessing improvements in knee pain and~     knee function.~   "
101634|NCT02236988|"~     To study how the body absorbs apremilast, and how this absorption is affected when the drug~     is given as different formulations. Blood samples will be taken to look at the amount of~     study drug in the blood to determine how much apremilast is absorbed by the body. This study~     is beng done to iddentify the best tablet formulation (preparation) of apremilast.~   "
101635|NCT02236975|"~     Prospective, multi-center, randomized 1:1, single blind trial using BuMA Supreme versus~     Resolute Integrity conducted in approximately 14 interventional cardiology centers in The~     Netherlands, Belgium, Spain and Portugal.~      Clinical follow-up will occur at 1, 9 and 12 months post-stent implantation. All patients~     will undergo repeat angiography at 9 months follow-up. QCA assessment will be performed at~     baseline (pre- and post-procedure) and at 9 months follow-up.~   "
101636|NCT02236962|"~     Obesity is epidemic in Australia, and current preventative strategies have had limited~     success in alleviating this health crisis. While numerous options are available for treatment~     of obesity, most do not result in sustained weight reduction. Obesity results from an~     imbalance between energy intake and expenditure, therefore new methods that correct this~     imbalance are essential for effective long-term treatment. Rodent studies show that brown~     adipose tissue (BAT) can burn more energy than any other tissue in the body, therefore~     targeting BAT to increase its activity (energy burning rate) and quantity in humans is~     potentially a powerful tool for the treatment of obesity and related diseases. BAT has only~     recently been irrefutably identified in adult humans therefore little is known about how it~     functions in humans.~   "
101637|NCT02236949|"~     The purpose of this research study is to evaluate the effectiveness of short refresher~     sessions. Pain Practice Change Boosters given at regular intervals to sustain improved pain~     process (assessment and management) and clinical outcomes (pain intensity) achieved during a~     15 month knowledge translation intervention, Evidence-based Practice for Improving Quality~     (EPIQ), in 8 children's hospitals in Canada; and to determine the factors that affect that~     sustainability. The CIHR Team in Children's Pain (2006-2011) evaluated the effectiveness of~     the EPIQ intervention in 32 hospital units (4 units at each hospital site). 16 hospital units~     were allocated to the intervention group and 16 units continued with standard care. The~     current study focuses on the 16 hospital units that implemented the EPIQ intervention only.~   "
101638|NCT02236936|"~     Prevention of critical weight loss. In patients with Squamous Cell Carcinoma of the Head and~     Neck (SCCHN) weight loss is a relevant clinical problem during radiotherapy and might result~     in higher treatment related toxicity and discontinuation of a potential curative treatment.~     Thus the investigators want to evaluate the efficacy of overnight parenteral nutritional (PN)~     support in patients with SCCHN treated with curative radiotherapy (RTX) in combination with~     Cetuximab (E) or Cisplatin (P).~   "
101639|NCT02236923|"~     That the full-moon stage of the lunar cycle is associated with reduced mortality and shorter~     length of stay in patients undergoing repair of aortic dissection, after adjusting for~     seasonal effects, demographics and cardiovascular risk factors.~   "
107457|NCT02160860|"~     Epidemiology of Helicobacter Pylori Infection Among Shanghai Children.~   "
101640|NCT02236910|"~     Lu-DOTA-TATE (Lutetium-177 octreotate) is a radiopharmaceutical that has been reported as~     being effective in controlling symptoms and increase quality of life; induce stable disease~     and extend progression free survival; induce a (good) partial remission and induce a complete~     remission in patients with a somatostatin receptor positive tumour.~      The purpose of this study is to assess the efficacy of Lu-DOTA-TATE by measuring progression~     free survival and overall survival. This study will also asses the safety of Lu-DOTA-TATE,~     and the quality of life of the patients treated with Lu-DOTA-TATE.~   "
101641|NCT02236897|"~     This is a pilot study to evaluate a potential imaging biomarker for aiding diagnosis and~     monitoring progression of ALS, based on a well established basic science pathway, published~     human autopsy data, preliminary data in ALS mutant mice, and our recently published data~     using brain PET scans to image the metabotropic glutamate receptor type 5 (mGluR5) in healthy~     human volunteers.~   "
101642|NCT02236884|"~     During the past three years, a revolutionized radical surgical approach for rectal cancer~     (down to up TME  approach or transanal TME (TaTME)approach, which is opposite to the~     conventional approach) has emerged and it is a concept that combines natural orifice~     transluminal endoscopic surgery(NOTES) and total mesorectal excision(TME) with curative~     intent. The feasibility, safety and reproducibility of it were first demonstrated in swine~     survival experiments and subsequently in human cadaver series, and then it was successfully~     applied to human patients in few centers around the world, most of which were performed with~     assistance of laparoscopy, namely hybrid transanal TME. In addition, pure-NOTES without~     conventional laparoscopic assistance (no scar) has also been demonstrated, though the cases~     were more limited. In the initial stage, our group has successfully performed this no-scar~     transanal TME in a series of human cadavers with satisfactory outcome. Hence the~     investigators conduct this study, looking to see if this pure transanal NOTES investigational~     procedure is a safe and effective approach to radically remove rectal cancer of the mid and~     lower rectum and meanwhile, if it can reduce pain, gain faster recovery and better function~     and life quality when gaining the best cosmetic effect.~   "
101643|NCT02236871|"~     The final stages in the development of peak bone mass (PBM) reside in late adolescence or~     early adulthood and are critical in the achievement of bone health. Optimization of PBM and~     maintenance of bone mineral density (BMD) are the best population health strategies in the~     primary prevention of osteoporosis. Diet and activity are key lifestyle factors in the~     primary prevention of osteoporosis as recognized in Canada's Food and Activity Guides.~     Dietary Reference Intakes are evidence-based regarding nutrition and bone health with a focus~     on calcium and vitamin D; yet the Food Guide and health behaviors are reliant on actual~     foods. The number of recommended servings of milk and alternatives varies by age with average~     intakes estimated to be below targets for all Canadians > 9 y of age. This is especially~     concerning during development of PBM. Therefore, the global objective is to generate~     high-level evidence that dietary intervention with milk and milk products will enhance PBM in~     young men and women and maintenance of BMD in their parents.~      The primary objective is to demonstrate in healthy young men and women (14-18.9 y at~     baseline) with habitually low usual milk and milk product intakes that intervention with~     greater milk and milk product consumption improves lumbar spine BMD in a dose-response manner~     over 2 y (while accounting for body size, physical activity, demographics and age). Healthy~     young men and women will be recruited and screened for usual intake of milk and milk~     products. Those with low intakes < 2 servings of milk or milk products will be randomized~     (stratified by sex and age) to 1 of 3 groups for the RCT (n=10090/group): maintain usual low~     intakes (<1 serving), improved intakes (average of 2 servings/d) or recommended intakes (≥3~     servings/d) of milk and milk products. A manualized motivational interviewing framework will~     be used for the interventions. Those meeting recommendations at screening will form a~     longitudinal cohort for 2 y. Key measurements include baseline and yearly assessment of BMD~     at multiple sites plus interim assessment of general health, anthropometry, dietary intakes,~     physical activity and biomarkers of calcium homeostasis; and in the young adults bone~     metabolism.~   "
101644|NCT02236858|"~     Objectives (include all primary and secondary objectives)~      Specific Aim #1: To determine whether an air cleaner intervention to improve home air quality~     will improve respiratory symptoms, quality of life, lung function and reduce risk of~     exacerbations in former smokers with COPD.~      Hypothesis: An intervention using high-efficiency particulate air (HEPA) and carbon filter~     air cleaners in homes of former smokers with COPD will improve respiratory symptoms, quality~     of life, and lung function and reduce risk of COPD exacerbations compared with placebo (sham~     air cleaners).~      Specific Aim #2: To determine whether an air cleaner intervention to improve home air quality~     will be associated with intermediate outcome measures known to be linked with long term~     outcomes in COPD, including airway and systemic markers of inflammation and oxidative stress,~     in former smokers with COPD.~      Hypothesis 2: An intervention using HEPA and carbon filter air cleaners in homes of formers~     smokers with COPD will be associated with lower levels of markers of inflammation and~     oxidative stress known to be associated with adverse outcomes in patients with COPD.~   "
101645|NCT02236845|"~     The study will assess the safety, tolerability and feasibility of Lacrima investigational~     medical device vs. sham device in adult patients with chronic Insomnia~   "
101646|NCT02236832|"~     Frontal patients are impaired in categorisation and analogical reasoning tasks, and different~     functional imaging studies from our group have shown the involvement of the prefrontal cortex~     in categorisation and analogy tasks. The aim of this project is to test our hypotheses about~     the role of the prefrontal cortex in explicit and implicit categorisation and analogy tasks.~   "
101647|NCT02236819|"~     There is considerable variation in the incidence of out-of-hospital cardiac arrest (OHCA)~     across Europe. The likelihood of attempted resuscitation also varies. To better understand~     the factors that contribute to variation, more data on incidence, management and outcomes~     from OHCA is required. A European, multi-centre study provides the opportunity to uncover~     differences throughout Europe and may help find explanations for these differences. Results~     may also have potential to support the development of quality benchmarking between European~     Emergency Medical Services (EMS).~      This prospective European study will involve 27 different countries. It provides a common~     Utstein-based dataset, data collection methodology and a common data collection period for~     all participants, thereby potentially increasing comparability.~      Study research questions will address the following: OHCA incidence in different European~     regions; incidence of cardiopulmonary resuscitation (CPR) attempted; initial presenting~     rhythm in patients where bystanders or EMS starts CPR or any other resuscitation~     intervention; rate of any return of spontaneous circulation (ROSC); patient status at~     handover to a hospital i.e. ROSC, ongoing CPR, dead; incidence of patients still alive 30~     days after OHCA; incidence of patients discharged alive from hospital.~   "
101648|NCT02236806|"~     The aim of the study is to analyze the protective impact on the cardiac damage of beta~     blockers and ACE inhibitors for breast cancer patients treated with anthracyclines-based~     chemotherapy with or without trastuzumab.~   "
113915|NCT02076399|"~     The purpose of this study is to determine whether fostamatinib is safe and effective in the~     treatment of persistent/chronic Immune Thrombocytopenic Purpura (ITP).~   "
101649|NCT02236793|"~     The present clinical trial is designed to assess the effectiveness of BioChaperone PDGF-BB~     applied at 4 µg/cm² every other day for up to 20 weeks and associated to Standard of Care as~     compared to Standard of Care alone for the treatment of neuropathic and neurovascular~     diabetic foot ulcers.(In order to ensure the double-blinding of the treatments, a sterile~     normal saline solution presented in the same multi-dose spray vials than BioChaperone PDGF-BB~     will be applied on patients of the control group).~   "
101650|NCT02236780|"~     The main purpose of the study is to assess the impact of environmental conditions on~     live-birth rates after intraconjugal IVF.~      The second purposes are~        -  to assess the impact on pregnancies (prematurity, preeclampsia);~        -  to assess the impact on newborn's health (stunted growth);~        -  to evaluate the consistency of results observed between assisted pregnancies and~          spontaneous pregnancies.~   "
101651|NCT02236767|"~     This is multiple baseline study including up to three participants with a primary diagnosis~     of hoarding disorder. All patients will receive unblinded repetitive transcranial magnetic~     stimulation study intervention.~   "
101652|NCT02236754|"~     Type 1 diabetes mellitus (T1DM) develops when there is impaired insulin production due to~     loss of insulin producing cells (beta cells). The amount of insulin that can be produced is~     imperfectly correlated with beta cell mass (BCM). The development of a reliable method to~     noninvasively quantify the total amount of insulin producing beta cells would be of great~     benefit by providing an important endpoint for the development of new treatments of diabetes.~     The investigators have previously identified a specific marker on islet cells called~     vesicular monoamine transporter 2 (VMAT2) that the investigators now propose to use in~     positron emission tomography (PET) scanning to determine islet beta cell mass. The PET~     radiopharmaceutical 18F-fluoropropyl(FP)-dihydrotetrabenazine(DTBZ) has been used previously~     in human subjects without adverse effects. It has shown promise in differentiating type 1~     diabetes and non-diabetes. The investigators now hypothesize that repeat PET scans will be~     reproducible in the same subject. Subjects with normal BCM will be recruited from among~     normal weight non-diabetic people with plasma insulin levels within the normal range.~     Subjects with predicted reduced BCM will be recruited from among patients with T1DM who have~     low or non-measurable insulin levels. Two PET scan measurements will be taken in each subject~     and the amount of VMAT2 in the pancreas will be and compared for reproducible findings.~     Biochemical testing will also be performed and compared to PET scans as a potential indirect~     marker of beta cell mass.~   "
101653|NCT02236741|"~     Study to assess the risk of incident heart failure associated with the use of pramipexole~     compared with other dopamine agonists and additionally, to assess the risk of incident heart~     failure associated with the use of dopamine agonists in comparison with no use of dopamine~     agonist therapy~   "
101654|NCT02236728|"~     The primary objective of this study was to describe neurologists' population of patients~     treated with pramipexole and suffering from Parkinson's disease (so called 'primary care'~     population).~      The secondary objectives were:~        -  Evaluate the mean dose of pramipexole prescribed under actual conditions of use~          depending on the severity of the disease.~        -  Evaluate the reasons for choosing pramipexole as treatment.~        -  Identify the patient profiles determining the choice of dose of pramipexole prescribed~   "
101655|NCT02236715|"~     Study to obtain further information on the tolerability and efficacy of Atrovent® unit dose~     vial 500 µg in the treatment of Chronic Obstructive Airways Disease under conditions of daily~     practice~   "
101656|NCT02236702|"~     The purpose of this study is to use positron emission tomography (PET) imaging to measure the~     activity of the kappa opioid receptor (KOR) in the brains of depressed and non-depressed~     individuals.~   "
101657|NCT02236689|"~     Tennis elbow is a common occurrence in the general population that causes lateral elbow pain~     and diminished grip strength, which may be debilitating. Most affected individuals achieve~     symptom resolution within 6 months to 1 year with measures such as physiotherapy,~     anti-inflammatories and corticosteroid injections, but a small subset will go on to develop~     chronic symptoms. Chronic tennis elbow can be treated surgically, with arthroscopy gaining~     popularity in recent years as it presents a less invasive option, allows for direct~     visualization of the elbow joint for other pathology and has a faster return-to-work time~     compared to other surgical procedures. Despite its promise there have been no high quality~     studies evaluating the efficacy of arthroscopic tennis elbow release, bringing the actual~     efficacy of this procedure into question. We propose a randomized, double-blind controlled~     trial comparing arthroscopic release with arthroscopic debridement for the management of~     chronic tennis elbow in an effort to definitively answer this question and provide better~     recommendations for the use of this procedure.~   "
101658|NCT02236676|"~     The purpose of this research study is to better understand how a daytime nap after training~     on a motor skill after brain injury improves performance compared with the same amount of~     time after training spent awake and resting.~   "
101659|NCT02236663|"~     Intimate partner violence (IPV), including violence in dating relationships (dating violence,~     DV) is a widespread and serious public health problem. Among U.S. female IPV survivors, 47.1%~     report their first abusive relationship occurred at college age (age 18-24). Similarly, in~     national surveys, adults respondents 18-24 years of age report the highest rate of stalking~     victimization, most commonly by a former intimate partner. Safety planning is the most widely~     used intervention to prevent and respond to IPV, yet the vast majority of abused women never~     access safety planning services. Our challenge is to increase college women's access to~     safety planning, with the opportunity to consider their unique safety priorities and level of~     danger during and when ending an abusive relationship. In addition, while bystander~     interventions that train peers to safely intervene have been shown to be effective in sexual~     assault prevention on campus, and college women in abusive relationships most frequently~     disclose IPV to a friend, no similar interventions have been tested with friends for IPV~     response on campuses. Therefore, the objective of the study is to evaluate the:~        1. effectiveness of an interactive, personalized smart phone and web based safety~          application (App) intervention in Maryland and Oregon with: 1) college women (age~          18-24) who experience IPV and 2) friends (age 18-24) of women experiencing IPV. The~          safety decision App allows the user to enter information on: a) relationship health; b)~          safety priorities; and c) severity of violence/danger in relationship. The App then uses~          the information to provide the user with a personalized safety planning information and~          resources; and~        2. dissemination of the App in an expanded four states (Arizona, Maryland, Missouri, and~          Oregon) to determine the reach, adoption, implementation and maintenance of App use~          among university/college students.~   "
101660|NCT02236650|"~     The purpose of this study is to determine the effectiveness of Primary Care Stepping Stones~     Triple P (PC-SS Triple P), an empirically supported parent mediated intervention, to improve~     the behavioral functioning of children newly diagnosed with Autism (aged 2-12 years),~     increase parental resilience and decrease parental stress.~   "
101661|NCT02236637|"~     The purpose of this registry is to document the characteristics and management of patients~     with metastatic castrate resistant prostate cancer (mCRPC) in routine clinical practice,~     independent of treatment used. Given the rapidly evolving landscape in mCRPC treatments,~     there is a need for a current and improved understanding of how these treatments fit into the~     current treatment paradigm for mCRPC, how they are combined and sequenced, and how their~     relative effectiveness profiles emerge outside of a clinical trial setting. This will be~     based on documentation and description of sequencing of treatment initiation, termination,~     and duration; relative effectiveness of treatments; defined medical resource utilization~     (MRU) and quality-of-life parameters and follow-up for survival.~   "
101662|NCT02236624|"~     The purpose of the present study is to test the hypothesis that aerobic training can reduce~     flu-like symptoms following interferon beta 1a injections in patients with Multiple~     Sclerosis.~      A secondary purpose is to evaluate whether or not changes in circulating cytokines provide a~     mechanism that can explain a potential positive effect.~   "
101663|NCT02236611|"~     This is a 12-week, multicentre, randomized, open-label, 2-arm, parallel-group study designed~     to compare the efficacy and safety of umeclidinium inhalation powder (62.5 mcg once daily~     [QD]) administered via a novel Dry Powder Inhaler (nDPI) with glycopyrronium (44 mcg QD)~     administered via a Breezhaler® inhaler in subjects with COPD over 12 weeks of treatment. At~     the end of the run-in period, eligible subjects will be randomized in a 1:1 ratio to receive~     umeclidinium 62.5 mcg administered via nDPI or glycopyrronium 44 mcg administered via~     BREEZHALER inhaler. There will be up to 8 clinic visits conducted on an outpatient basis at~     Pre-Screening (Visit 0), Screening (Visit 1), Randomization at Day 1 (Visit 2), and after~     Randomization at Day 2 (Visit 3), Day 28 (Visit 4), Day 56 (Visit 5), Day 84 (Visit 6) and~     Day 85 (Visit 7). The total duration of subject participation in the study will be~     approximately 15 weeks. The primary endpoint of the study is clinic visit trough FEV1 (forced~     expiratory volume in one second) on treatment Day 85. All subjects will have spirometry~     performed at clinic Visits 1 though 7. Trough spirometry will be obtained 23 and 24 hours~     after the previous day's dose of open-label study medication at Visits 3 to 7.~      BREEZHALER is a registered trademark of Novartis AG.~   "
101664|NCT02236598|"~     African Americans suffer a disproportionately high risk of diabetes compared to other~     Americans. Reasons for race disparities in diabetes incidence are not completely understood.~     Although a difference in prevalence of obesity does explain a significant portion of the~     racial disparity in diabetes risk, it does not explain all of this disparity. Strategies to~     control the diabetes epidemic and reduce its racial disparity often overlook preventive~     measures. Currently, the most powerful known strategy for preventing diabetes is weight loss~     in the overweight/obese. However, because weight loss is often difficult to achieve and~     maintain, other opportunities to prevent diabetes should be identified, particularly in~     African Americans. Among potential novel opportunities is correction of low or low-normal~     potassium levels (hypokalemia). In secondary analyses, we have found low-normal potassium (K)~     to be a novel risk factor for diabetes; and we have found that this association between low-K~     and diabetes risk may be stronger in African Americans compared to whites. Therefore, a~     previously unrecognized alternative or adjunct strategy for preventing diabetes, particularly~     in African Americans, may involve correction of low or low-normal K levels (hypokalemia).~     Large-scale, adequately-powered, randomized controlled trials are needed to establish the~     effectiveness of this approach. However, prior to those trials, the pathophysiology of the~     association between low K and poor glucose metabolism must be understood. This pilot clinical~     trial will begin to determine the effect of K supplementation on measures of glucose~     metabolism in African Americans.~      In this pilot clinical trial, 30 African Americans with prediabetes and a low-normal serum K~     [<4.0 milliequivalent/Liter (Eq/L)] will be randomized to K-supplements, 20mEq (2-10mEq~     tablets) twice daily or a matching placebo capsules twice daily. Prior to randomization,~     baseline measures will be taken including measures of glucose metabolism with a 3-hour oral~     glucose tolerance test (OGTT), baseline chemistries and a baseline 24-hour urinary potassium~     measurement. Patients will take the intervention daily and will undergo repeat testing of all~     of these measures at the end of a 3 month period. The primary endpoint will be change in~     glucose tolerance, as measured by change in glucose area-under-the-curve (AUC) of a 3-hour~     oral glucose tolerance test (OGTT). Secondary endpoints will include changes in fasting,~     1-hour, and 2-hour post-challenge glucose levels, as well as measurements of insulin~     secretion and insulin sensitivity as measures by the oral glucose minimal model method.(1)~     The baseline data from this trial will allow us to quantify abnormalities in glucose~     metabolism in African Americans with prediabetes/early diabetes and low-normal serum K. The~     post-intervention data will provide estimates of the impact of K-supplements compared to no~     supplements on these abnormalities. Data derived from the pilot study will be used in the~     design of a larger scale, adequately powered clinical trial. This trial will also help to~     assess the feasibility of recruiting this target population.~      With this pilot trial, we will begin to determine whether or not K-supplements, an~     inexpensive, well-tolerated, and simple intervention, could help to reduce diabetes risk~     among African Americans.~   "
101665|NCT02236585|"~     Uterine artery embolization (UAE) is commonly used to treat symptomatic uterine leiomyomata~     through induction of infarction and subsequent hyaline degeneration. This could be followed~     with variable severity of pain that lasts for several days after the procedure secondary to~     the resulted global uterine ischemia and fibroid infarction. Pain after UAE has been~     described as moderate to severe cramping increasing over the first 2 hours after UAE to reach~     plateaus for 5 to 8 hours before it rapidly decreases to a much lower level.1 The severity of~     pain after UAE seems unrelated to the uterine or fibroid size which makes the severity of~     pain is unpredictable.1~      Pain management after UAE most often consists of a combination of a non-steroidal~     anti-inflammatory drugs, acetaminophen and an opioid. However severe pain following~     embolization of the uterine arteries may require large doses of parenteral opioids for relief~     with added unwanted effects.2~      Additionally, patients received morphine intravenous patient-controlled analgesia (IV-PCA)~     after UAE needed considerable amounts of morphine (median [range] 24 mg [0-86 mg]) during the~     first 24 h after embolization.3 The addition of ketamine to IV-PCA failed to reduce morphine~     consumption for the first 24 hours after UAE. 2~      Nowadays, the use of lumbar epidural anesthesia has been standardized as the anesthetic~     choice for uterine artery embolization as it improves patients satisfaction and reduces the~     severity of post-procedural pain.~      Although some investigators suggest an epidural analgesia for pain control after UAE,4 the~     use of continuous lumbar epidural infusion of ropivacaine does not improve quality of pain~     management after UAE.5~      Thus in an observational study included few patients, the investigators demonstrated~     considerable postoperative analgesia lasted for 24 hours after UAE with the combined use of~     patient-controlled thoracic epidural analgesia (PCEA) and rectal diclofenac.6 However, the~     catheterization of thoracic epidural space in such low-risk patients has many logistic~     issues.~      Up to the best of our knowledge, there is no available comparative randomized clinical trial~     compares the use of continuous and patient-controlled lumbar epidural analgesia after UAE.~   "
101666|NCT02236572|"~     The purpose of this study is to see whether adding everolimus to hormone treatment before~     breast surgery will increase the chances of shrinking the breast cancer in those patients~     with hormone-responsive breast cancer and a lower Oncotype DX® Recurrence Score ( 25 or~     less), compared to prior experience with hormone therapy alone. Everolimus is a drug~     currently approved for use by the United States Food and Drug administration (FDA) for the~     treatment of patients with advanced or metastatic kidney or breast cancer. Everolimus is~     considered investigational for non-metastatic breast cancer patients.~   "
101667|NCT02236559|"~     The overall objective of this study is to determine if Vapotherm high flow nasal cannula~     therapy (HFT), when used to treat respiratory failure in the ED, is at least equivalent to~     the current standard of care for non-invasive ventilatory support, non-invasive positive~     pressure mask ventilation (NIPPV). Moreover, this study will investigate the potential that~     HFT has possible advantages over NIPPV, such as decreased time to patient stability from~     respiratory failure, and the ease of use as a first line intervention for respiratory failure~     in the ED environment.~      The hypothesis is that HFT via the Vapotherm Precision Flow will demonstrate clinical~     non-inferiority when compared to NIPPV with regard to treatment failure by way of an impact~     on ventilation indices and a lower intolerance rate, and have a positive association with~     hospital disposition and length of stay.~   "
101668|NCT02236546|"~     This clinical trial studies how well FDG-PET/CT measures early response in patients with~     stage III-IV melanoma who are receiving chemotherapy. Positron emission tomography~     (PET)/computed tomography (CT) uses a metabolic imaging radiotracer, [18F]fluorodeoxyglucose~     (FDG), which selectively accumulates in tumors. FDG-PET/CT of advanced melanoma before,~     during, and after treatment may improve methods for predicting which patients may benefit~     from therapy.~   "
101669|NCT02236533|"~     The aim of the project was the evaluation of the antioxidant and anti-inflammatory effects of~     a whole grain pasta, enriched in barley β-glucans and fortified with strains of Bacillus~     coagulans, versus a control wheat pasta on healthy volunteers, using a parallel randomized~     controlled trial.~   "
101695|NCT02236195|"~     Mocetinostat is an orally administered histone deacetylase (HDAC) inhibitor. This study is a~     Phase 2 trial evaluating the efficacy of mocetinostat in patients that have advanced~     urothelial carcinoma that has specific changes in tumor genes. Patients must have previously~     received treatment with chemotherapy that included a platinum-containing agent such as~     cisplatin. The study will enroll in stages, with 15 patients in the first stage. More~     patients will be added to the study if enough patients having beneficial responses are~     observed. Mocetinostat will be administered using oral capsules three times each week (eg,~     Monday, Wednesday and Friday). The study is designed to evaluate whether the number of~     patients responding to treatment is substantially higher than would be expected with other~     available treatments.~   "
101670|NCT02236520|"~     Cardiovascular disease is the first common cause of death worldwide. Hypertension is the~     number one driving risk factor. Hypertension has long been associated with dietary salt~     intake. We believe that the accumulation of salt in the interstitium and inside cells~     represents a neglected risk factor, which initiates a pro-inflammatory state, chronically~     increases blood pressure, and leads to systemic energy imbalance. We will explore the concept~     that Na+ storage in the skin and in muscle is associated with increased blood pressure, a~     pro-inflammatory state, and reduced insulin sensitivity. We will do so by addressing the~     following specific aims:~        -  Specific Aim 1: To test the hypothesis that African Americans are characterized by~          increased tissue Na+ storage, which is paralleled by higher blood pressure, reduced~          forearm blood flow, and enhanced pulse wave velocity~        -  Specific Aim 2: To test the hypothesis that treatment with spironolactone reduces tissue~          Na+ content~        -  Specific Aim 3: To test the hypothesis that Na+ storage leads to immune cell activation~        -  Specific Aim 4: To test the hypothesis that the accumulation of salt in skin and muscle~          is associated with decreased insulin sensitivity and propensity to diabetes mellitus~   "
101671|NCT02236507|"~     Anorectal 3D high resolution manometry (3D HRM) is the most advanced version of manometry~     equipment and has been recently introduced into clinical practice. It is the most precise~     method to assess the anal sphincter pressure function and may be crucial for planning and~     controlling surgical procedures of the anorectal area. Normal values in pediatric population~     have not been established.~      The aim of this study is complex evaluation of anorectal function in children without~     symptoms from lower GI tract and establishment of normal values.~   "
101672|NCT02236494|"~     This is a randomized trial to assess the value of an emergency department-based intervention~     to reduce hazardous alcohol use among older adults. We hypothesize that the intervention will~     result in a 25% reduction in the prevalence of hazardous alcohol use while the control group~     will only have a 5% reduction.~   "
101673|NCT02236481|"~     The TRACK [Treatment of Rheumatoid Arthritis and Comorbidities with Kineret~     (anakinra)]-study: a randomized, open-label multicenter study assessing the efficacy of~     anakinra in lowering HbA1c (glycated hemoglobin) as well as changes in DAS28 in Rheumatoid~     Arthritis (R.A.) patients with type 2 diabetes (T2D) Authors: R. Giacomelli,(A,B) P. Cipriani~     (A) and P. Ruscitti (A) on behalf of the TRACK study-group; (A) University of L'Aquila,~     L'Aquila, Italy; Background: Interleukin-1 (IL-1) plays a pivotal role in R.A., joint erosion~     and cartilage destruction.(1) Anakinra (a recombinant form of the naturally occurring IL-1~     receptor antagonist (IL-1Ra), which blocks the activity of both IL-1α and IL-1β) has shown in~     a number of RCTs (2-6) to be effective in the treatment of R.A., in monotherapy,(2,4) as well~     as associated to methotrexate (MTX).(3,5,6) IL-1β plays also an important role in the~     pathogenesis of T2D: Glucose has been shown to induce IL-1β hypersecretion through~     inflammasome activation, while IL-1β induces impairment of β-cell secretory function and~     β-cell apoptosis.(7) In prediabetic subjects, the expression of IL-1Ra is induced by IL-1β~     and reflects the body's response to counterbalance increased IL-1β activity.(7) Levels of~     IL-1Ra tend to rise up to 6 years before the diagnosis of T2D.(8,9) IL-1Ra has been~     successfully used as a marker for the risk of developing T2D in subjects with metabolic~     syndrome.(10) As a clinical proof of concept, IL-1 inhibition with anakinra in patients with~     T2D has shown to improve the secretorial function of beta-cells as well as to lower the ratio~     of proinsulin/insulin and glycated hemoglobin/hemoglobin significantly, favoring glycemic~     control and possibly reducing the severity and prevalence of the associated complications of~     this disease.(11) Summarizing, IL-1 inhibition with anakinra has a clinical impact on R.A. as~     well as T2D. As from 6-10% of Italian R.A. patients have also T2D, this trial aims at~     investigating the impact of IL-1 inhibition on both diseases. Very recent data also show that~     T2D is a predictor of response to anakinra-treatment in R.A. patients,(12) which furthermore~     justifies the use of anakinra in this subset of R.A. patients. Objectives: [Primary] To~     evaluate the change in HbA1c between baseline, 3 months, 6 months, 1 year and at last follow~     up of 2 years from the beginning; [Secondary] To evaluate the efficacy on controlling signs &~     symptoms of R.A., assessing the remission rate at 3 months, 6 months, 1 year and at follow up~     (2 years), using the evaluation scale of disease activity on 28 joints, DAS28 and SDAI~     improvements from baseline conditions over time points, according to EULAR response criteria.~     Methods: 200 patients in 28 Italian centers with active R.A. refractory to treatment with~     methotrexate and T2D will be enrolled and randomized to receive either 100mg of anakinra once~     daily by subcutaneous injection or any anti-TNF-alfa drug treatment. [84 subjects will be~     required in each treatment arm to reach 90% power with an alpha error of 0.05 to detect a~     mean difference between the study arms of 0.25 percentage points of HbA1c . The assumed~     difference of HbA1c is rather conservative when compared to previously published changes in~     T2D patients (11).] Anti-diabetic treatment is required to be unchanged for at least one~     month prior to enrolment. Patients will be invited to maintain dietary habits and lifestyle~     during the study period. Further details can be viewed on the trials website after~     subscription.(13) References: (1) Arend & Dayer, Adv. Imm. 1993; 54: 167-227. (2) Bresnihan,~     Arthritis Rheum. 1998; 41: 2196-2204. (3) Cohen, Arthritis Rheum. 2002; 46: 614-624. (4)~     Nuki, Arthritis. Rheum. 2002; 46: 2838-2846. (5) Cohen, ARD 2004; 63: 1062-1068. (6) Cohen,~     Rheumatology 2004; 43: 704-711. (7) Donath, Nat. Rev. Immunol. 2011; 11: 98-107. (8) Herder,~     Diabetes Care 2009; 32: 421-423. (9) Carstensen, Diabetes 2010; 59: 1222-1227. (10) Luotola,~     J. Intern. Med. 2011; 269: 322-332. (11) Larsen, NEJM 2007; 356: 1517-1526. (12)~     Missler-Karger, EULAR 2013, Abs. FRI0219. (13) http://www.anakinra-ra-diabetes.org/~     Disclosure: This trial is receiving support from Swedish Orphan Biovitrum AB according to the~     Italian law decree 17 December 2004. (B) speaker fees~   "
101674|NCT02236468|"~     The purpose of this study is to assess the long-term impact of the Enhanced Homestead Food~     Production Program implemented by HKI on household food security and nutritional status, as~     well as the impact on including additional interventions (BCC on WASH and malaria prevention,~     distribution of preventive lipid-based nutrient supplements (LNS)) to children aged 6-24~     months old, in addition to the standard E-HFP model.~   "
101675|NCT02236455|"~     The purpose of this study is to determine the effects of complementary therapies delivered~     via mobile technologies have a therapeutic effect on surgical patients' anxiety, pain, and~     self-efficacy in healing reports before, following, and at 10-day follow-up.~   "
101676|NCT02236442|"~     The purpose of this study is to determine if the use of a therapeutic and global protocol to~     relieve cephalalgia is helpful in the emergency department of Grenoble University Hospital.~   "
101677|NCT02236429|"~     Bacterial vaginosis (BV) is the most common vaginal infection in women. It is caused by a~     vaginal bacterial imbalance. Treatment with antibiotics is the standard of care but there is~     a high rate of recurrence. Almost half of women successfully treated suffer a recurrence~     within three months. Complications include risk factors for premature birth, increased~     transmission of sexually transmitted diseases and higher risk for carcinoma of cervix. The~     investigators proposed study is a cost effective treatment based on returning the normal~     microbial balance to the vagina. The investigators propose to transfer normal vaginal flora~     from healthy individuals to women with BV and thus restore normal vaginal flora and cure this~     disorder.~   "
101678|NCT02236416|"~     The principal aim of this study is to verify whether a program of supervised, multimodal~     physical exercise improves cognitive function and/or reduces the rate of cognitive decline in~     older adults~   "
101679|NCT02236403|"~     Blepharitis is a endemic inflammatory disease caused mainly by Demodex folliculorum and~     Demodex Brevis, This mites are often associated with anaerobic bacteria that produces a skin~     inflammation, so a intervention that reduces the number of mites and bacteria would be~     desirable. Ivermectin a macrolid compound have demonstrated activity against scabies and lice~     in humans and in animals and a single application have show a good response in lice~     eradication.~      In this study , investigators will determinate the security and effectiveness of this~     compound in the eradication of mites~   "
101680|NCT02236390|"~     The purpose of the proposed pilot study is to extend previous findings regarding the efficacy~     of a brief treatment for chronic posttrauma nightmares and sleep problems by integrating this~     treatment with evidence-based treatment for posttraumatic stress disorder (PTSD). Cognitive~     processing therapy (CPT) (Resick & Schnicke, 1996) is a well-established and efficacious~     evidence-based psychological treatment for PTSD in both civilian and veteran populations~     (Forbes et al., 2012; Monson et al., 2006; Resick et al., 2008; Resick, Nishith, Weaver,~     Astin, & Feuer, 2002). The U.S. Department of Veterans Affairs (VA) includes CPT among the~     first-line treatments for PTSD (National Center for PTSD, 2012). A modified protocol without~     the utilization of written exposure (CPT-C) may be more effective than the original protocol.~     However, despite such promising evidence, individuals who experience chronic nightmares and~     sleep problems tend to show smaller gains and persistent nightmares following PTSD treatment~     (Nappi, Drummond, & Hall, 2012). Given that nightmares are considered the hallmark of PTSD~     (Ross, Ball, Sullivan, & Caroff, 1989) and their treatment-resistant nature (Davis & Wright,~     2007), specific psychological treatments have been developed to target sleep disturbances and~     nightmares.~      Exposure, relaxation, and rescripting therapy (ERRT) is a promising psychological~     intervention developed to target trauma-related nightmares and sleep disturbances. Though~     further evidence is needed, ERRT has exhibited strong support in reducing the frequency and~     intensity of nightmares, as well as improving overall sleep quality in both civilian and~     veteran samples. In addition, significant decreases in PTSD and depression symptoms have been~     reported following treatment (Davis et al., 2011; Davis & Wright, 2007; Long et al., 2011;~     Swanson, Favorite, Horin, & Arnedt, 2009). ERRT is currently an evidence-level B suggested~     treatment (Cranston, Davis, Rhudy, & Favorite, 2011).~      There is a call to research suggesting the importance of treatment studies which focus on~     interventions that integrate nightmare and sleep symptom treatment with evidence-based~     treatment for PTSD (Nappi et al., 2012). In an effort to respond to this call, we propose to~     tailor ERRT for use in conjunction with CPT, and preliminarily test ERRT's additive effect to~     CPT in treating PTSD in community outpatients. We hypothesize that ERRT would increase CPT's~     treatment efficacy by its specific focus on trauma-related nightmares and sleep disturbances.~     Sleep difficulties are known to increase tension, and reduce one's ability to cope adaptively~     (Bonn-Miller, Babson, Vujanovic, & Feldner, 2010; Hofstetter, Lysaker, & Mayeda, 2005;~     Nishith, Resick, & Mueser, 2001). Thus, with improved sleep an individual may have additional~     personal coping resources for which s/he can use to address the broader trauma issues (Nappi~     et al., 2012). To test this integration, we will compare ERRT + CPT, CPT + ERRT, and CPT~     alone.~   "
101681|NCT02236377|"~     The purpose of this case series dismantling study is to extend previous findings regarding~     the efficacy of a brief treatment for chronic post-trauma nightmares by examining the dose~     effect and mechanism of change.~      Exposure, relaxation, and rescripting therapy (ERRT) is a promising psychological~     intervention developed to target trauma-related nightmares and sleep disturbances. ERRT has~     exhibited strong support in reducing the frequency and intensity of nightmares, as well as~     improving overall sleep quality in both civilian and veteran samples. In addition,~     significant decreases in PTSD and depression symptoms have been reported following treatment~     (Davis et al., 2011; Davis & Wright, 2007; Long et al., 2011; Swanson, Favorite, Horin, &~     Arnedt, 2009). ERRT is currently an evidence-level B suggested treatment (Cranston, Davis,~     Rhudy, & Favorite, 2011).~      Despite this evidence, the mechanism of change for ERRT remains unclear. We propose to~     conduct a set of case series in order to examine the possible mechanisms: psycho-education,~     dose response for exposure, and no exposure components of the treatment. Each part of the~     treatment is theorized to contribute to the improved treatment outcome and it is hypothesized~     that participants will benefit no matter what group they are in. All participants will~     receive 5 treatment sessions, conducted twice per week for about 90 minutes, of a modified~     version of ERRT.~   "
101682|NCT02236364|"~     Previous animal studies done by Dr. Brent Cameron in 2013 at the Univ. of Toledo have shown~     that glucose present in the fluid in the front of the eye, called the aqueous humor,~     correlates well with blood glucose. As blood glucose changes, the optical properties of the~     aqueous humor change, causing a change in the appearance of the iris of the eye.. The data~     collected in this study will be shared with IRISense to assist in validating the algorithm~     being used to develop the database needed. The data collected so far is in a narrow band of~     the normal glycemic range (healthy volunteers). We will collect standard digital photographic~     images of the eyes of subjects with diabetes along with corresponding blood glucose~     concentrations using the finger stick glucose monitoring method. In order to do this we will~     use standard digital photography techniques that is embedded in our benchtop prototype device~   "
101685|NCT02236325|"~     A significant percentage of individuals who die by suicide do not seek mental health services~     in the time preceding their death. This population is underserved and it is unclear what~     barriers keep them from seeking treatment. In order to begin a line of research aimed at~     addressing this high-risk population, this proposal rests on the hypothesis that suicidal~     individuals who do not seek treatment prior to attempting suicide experience the same~     psychopathological difficulties as suicidal individuals who do seek treatment - namely,~     severe emotion dysregulation. However, these non-treatment-seeker s will likely require more~     creative recruitment strategies and briefer interventions than treatment-seeking individuals.~     As such, this application proposes to use wide-reaching recruitment efforts throughout the~     community to locate and enroll individuals who are suicidal but not seeking treatment.~     Further, there is a paucity of empirical support for interventions targeting suicidal~     individuals. Dialectical Behavior Therapy (DBT) is one of the few treatments that have been~     demonstrated to be effective with a suicidal population and is the only treatment whose~     effectiveness has been replicated. Previous research has suggested that an abbreviated~     version of the skills that are taught in DBT skills training have effectively reduced emotion~     dysregulation (i.e., depression and anxiety) in problem drinkers and the format of the~     proposed intervention is derived from this evidence-based emotion dysregulation intervention.~     As such, the proposed research is a randomized, controlled pilot trial of a very brief,~     one-time, skills-based intervention targeting difficulties in emotion regulation and distress~     tolerance.~      This research aims to evaluate the safety of the intervention, the feasibility of the~     research methods (including the appropriateness of the relaxation training control~     condition), and to preliminarily estimate the immediate (one week) and long-term (one and~     three month) changes resulting from the DBT Brief Skills Intervention (DBT-BSI) relative to a~     relaxation training control on the primary outcomes of suicide ideation and emotion~     dysregulation as well as a number of secondary outcomes. These results will inform the design~     of a subsequent full-scale randomized controlled trial of the DBT-BSI.~   "
101686|NCT02236312|"~     The primary objective of the study is to evaluate the efficacy in wrinkle reduction of a~     single treatment of three different doses of botulinum toxin compared to placebo, in the~     treatment of moderate to very severe glabellar frown lines.~   "
101687|NCT02236299|"~     The heart requires nutrients and oxygen carried in the blood to generate energy for healthy~     pump function. Blood is supplied via heart vessels called coronary arteries. When the~     arteries narrow the investigators call this coronary artery disease. Narrowing and blockage~     of the coronary arteries can cause chest pain (angina), breathlessness (due to a reduction in~     pump function) and if prolonged even irreversible muscle damage known as a heart attack. The~     investigators can treat patients with coronary artery disease with drugs that reduce the~     workload on the heart or with balloons and hollow metal tubes (stents) to open the narrowed~     coronary arteries and improve the blood supply. These treatments can relieve angina, improve~     breathlessness and avert heart muscle damage during a heart attack. A potential new~     mechanistic effect is emerging by modulating the type of fuel used by the heart to generate~     energy more efficiently has been tested in the left ventricle. This study is designed to see~     if mechanistic effect provides the same protection in the right ventricle. It is hoped that~     this may further improve heart pump function and reduce the size of a heart attack in~     patients with coronary artery disease.~   "
101688|NCT02236286|"~     This project will relate our new quantification of Freezing of Gait (FoG) in Parkinson's~     disease, using body worn inertial sensors (Aim I), with abnormalities in state-of-the-art,~     resting state, functional brain connectivity (Aim II), and determine the number of subjects~     needed for a future, randomized clinical trial to test the efficacy of our novel, Agility~     Boot Camp (ABC) rehabilitation intervention for FoG (Aim III). The technological approaches~     to these aims are cutting edge and will allow us to develop sensitive behavioral and brain~     biomarkers for gait disorders in Parkinson's disease (PD) for use in future clinical trials.~   "
101689|NCT02236273|"~     Emerging communication technologies, such as text messaging offer low-cost, scalable~     opportunities to improve health literacy and promote healthy behaviors, such as vaccination.~     While the investigators reported the success of text message vaccine reminders, effects were~     limited by their untailored approach. The trans-theoretical model of behavior change supports~     tailoring interventions to an individual's stage of decision-making. Human papillomavirus~     (HPV) is the most prevalent sexually transmitted virus in the U.S. and can lead to genital~     warts, and cervical, anal and penile cancer. The three-dose vaccine is 90-100% efficacious.~     Minorities are at greatest risk for such cancers but have low HPV vaccine completion rates.~     Limited health literacy regarding the vaccine can affect series completion. The investigators~     will compare the effects of enhancing text message vaccination reminders with interactive,~     vaccine health literacy-promoting information tailored to vaccine decision making-stage on~     HPV vaccine series completion. The effects of these messages represent a new paradigm in~     interactive health communications.~   "
101690|NCT02236260|"~     The effectiveness of Deep Brain Stimulation (DBS) in certain movement disorders is widely~     demonstrated. The success of this procedure requires that the patient is awake and~     cooperative. The conditions of this intervention can be difficult to tolerate by the patient~     for several reasons: long procedure (from 3 to 8 hours), body immobilisation (particularly~     the head in the stereotactic frame), stress related to the localization of the DBS. It is~     therefore important to improve the comfort as well as the cooperation of the patient, during~     implantation of the DBS electrodes, in order to optimize the conditions of the intervention.~     In addition to analgesia, acupuncture should allow sedation without affecting alertness and~     should contribute to the regulation of any vegetative reactions during the procedure.~     Therefore, we hypothesize that acupuncture could improve the quality of care of the patient~     during a DBS procedure. In practice, this is electroacupuncture that will be used in this~     research to maintain the stimulation of acupuncture points to an optimal level during the~     time of the intervention.~   "
101691|NCT02236247|"~     Study aims to compare the I(f) inhibitor ivabradine with placebo as strategy of heart rate~     control in patients with decompensated heart failure (DHF).~   "
101692|NCT02236234|"~     Besides the specific response to vaccine antigens, the investigators will analyze the~     anti-HPV immune response in HIV-1-infected men in different strata of immune deficiency. The~     hypothesis will be tested by stratification by T CD4 + lymphocytes in an attempt to assess~     the range of the count with the highest possibility of vaccine response. Thus, knowledge of~     vaccine response in HIV-infected patients, indicate which patients would have greater~     potential for vaccine response in vivo.~   "
101693|NCT02236221|"~     The purpose of this study is to observe the effect of lack or excess of Vitamin D in the~     first, second and third trimester on child birth weight, fat content and the secretion of~     metabolism related hormone, and clinical follow-up their offspring obesity.~   "
101694|NCT02236208|"~     The purpose of this study is to observe the effect of lack or excess of folic acid in first,~     second and third trimester on child birth weight, fat content and the secretion of metabolism~     related hormone, and clinical follow-up their offspring obesity.~   "
101696|NCT02236182|"~     Study to assess the safety of two-week administration of 80 and 160 mcg of ipratropium~     bromide as delivered by the RESPIMAT® device and as determined by 24 hours ambulatory ECG~     monitoring in COPD patients. To assess the overall safety of the two doses of ipratropium~     bromide as delivered by the RESPIMAT® device when administered over a two-week period.~   "
101697|NCT02236169|"~     The objective of this study was to determine the pharmacokinetic comparability of 84 µg~     ipratropium bromide HFA-134a inhalation aerosol and 84 µg ATROVENT® CFC Inhalation Aerosol in~     COPD patients~   "
101698|NCT02236156|"~     A double-blind, phase 3 study to determine the efficacy of SPL7013 Gel when administered on~     alternate days for 16 weeks, compared to placebo gel in preventing the recurrence of BV in~     women with a history of recurrent BV.~   "
101699|NCT02236143|"~     The primary objective of this study is to develop new ways to acquire MRI data and/or new~     ways to analyze the acquired data.~   "
101700|NCT02236130|"~     Context:~      Single shot peripheral nerve blocks have limited duration of action depending on the local~     anesthetic agent used in the block. But it rarely lasts longer than 12 hrs. Patients need~     oral analgesics at home once the block wears off to control the pain.~      Objectives:~      Primary Objective~      To determine if peripheral nerve blocks have any advantage in terms of decreasing oral~     analgesic requirements in the post operative period even after the effects of the block have~     worn off~      Secondary Objective~      To determine if inclusion of single shot regional technique improves patient/family~     satisfaction with post operative pain management .~      Study Design:~      Prospective randomized single blinded study.~      Inclusion Criteria~        -  Children aged between 6 yr and 17yr scheduled for ambulatory peripheral orthopedic~          surgery with moderate to severe postoperative pain.~        -  Surgery of moderate duration (<2hr)~        -  Surgery associated with minimal blood loss or fluid shifts (<10% total blood volume)~        -  American Society of Anesthesiologists (ASA) classification 1 or 2~        -  Parents able to understand follow up instructions and are able to reach at home by phone~      Exclusion Criteria~        -  Known allergy to local anesthetics~        -  Preexisting neuropathy with sensory or motor deficits~        -  Skin infection at site of needle placement~        -  Parents refusal for peripheral nerve blocks~   "
101701|NCT02236117|"~     The heart rate variability is a tool used to asses non-invasive cardiac autonomic. In fact,~     many studies have been disseminated of heart rate variability in adults, however few results~     in a literature this parameters in pediatric population, mainly with children submitted the~     physical training. Thus, this Project aims to verify the effects of aerobic training, with 10~     weeks, in prepubertal on the performance and heart rate variability in rest.~   "
101702|NCT02236104|"~     A single session of Mechanical Insufflation-Exsufflation (with Cough AssistÒ) may improve~     airway flow and gas exchange in neuromuscular atrophy patients. The goal of this study is to~     confirm the beneficial effects of this treatment in a larger neuromuscular population, to~     study its mechanisms of action and to assess whether the effects observed persist over time.~     A better knowledge of this treatment should help to define its position in the respiratory~     management of neuromuscular patients.~   "
101703|NCT02236091|"~     The overall aim of this project is to monitor everyday life activity of children with~     neurological disorders undergoing rehabilitation using wearable sensors capable of accurate~     and unobtrusive long-term measurement.~      Specific objectives:~        1. To adapt the sensors for the use by children with neurological disorders. The focus lies~          on the exact positioning and the investigation of the needed amount of IMUs.~        2. To validate the sensor data with collected video recordings and to develop specific~          algorithms to automatically extract specific movements and to analyze long-term sensor~          recordings.~        3. To perform a cross-sectional study to assess intensity, task-specificity and duration of~          upper and lower limb activity during rehabilitation. There, we aim to gain objective~          information about levels and types of activity during rehabilitation in relation to age,~          gender and disorder.~        4. To conduct a responsiveness study to assess whether or not the sensor output is able to~          highlight changes over time during rehabilitation.~      Therefore, at time point T=0 (shortly after admission to our center), participants are~     equipped with 3 inertial measurement units (1 at each wrist and 1 at the sternum).~     Additionally, a small wearable camera is mounted to the chest. The participants then return~     to their everyday life for 4 hours (no therapies, measurement period is in the evening).~     Afterwards, the equipment is removed again. To investigate responsiveness, the same protocol~     is being repeated 4 weeks later (time point T=1).~   "
101704|NCT02236078|"~     Multidrug-resistant (MDR) tuberculosis (TB) must be treated with second-line drugs (SLD) that~     are less effective, more toxic, and more expensive. Treatment requires at least 20 months~     with 4 or more effective drugs based on timely drug susceptibility test (DST) results.~     However, there are many examples of closely related drugs with differing antimicrobial~     activities.~      Labs have found differences in DST results among the rifamycins, rifampin (RMP) and rifabutin~     (RBT); the fluoroquinolones, ofloxacin and moxifloxacin; and the second-line injectable~     agents, kanamycin, amikacin, and capreomycin. In a related finding, isolates resistant to 0.2~     mcg/ml INH may be susceptible to higher concentrations. In the Preserving Effective~     Tuberculosis Treatment Study (PETTS), 32% of RMP-resistant isolates were susceptible to RBT,~     41% of kanamycin-resistant isolates were susceptible to capreomycin, and 45% of isolates~     resistant to 0.2 mcg/ml INH were susceptible to 1.0 or 5.0 mcg/ml (1). Other studies have~     demonstrated differences in DST results between moxifloxacin and ofloxacin. Whether these in~     vitro results translate into clinical efficacy is completely unknown. Given the severely~     limited treatment options in MDR TB, it would be exceedingly useful to know whether these in~     vitro results translate into evidence for clinically meaningful treatment decisions.~      The investigators will determine the clinical bactericidal activity of certain antibiotics~     against M. tb that appear to be effective in vitro even though closely related drugs from the~     same class are ineffective in vitro. Further, the investigators propose to determine the~     molecular genetic determinants of these differences.~      Specifically, we plan to determine:~        1. The bactericidal activity of RBT in patients whose baseline DST results demonstrate~          susceptibility to RBT and resistance to RMP.~        2. The bactericidal activity of high-dose INH in patients whose baseline DST results~          demonstrate susceptibility to high concentrations of INH and resistance to low~          concentrations of INH.~        3. The bactericidal activity of RMP when an approved molecular assay demonstrates genetic~          mutations associated with RMP resistance, but the phenotypic testing demonstrates~          susceptibility to RMP.~        4. The bactericidal activity of moxifloxacin in patients whose baseline DST results~          demonstrate susceptibility to moxifloxacin and resistance to ofloxacin.~        5. The bactericidal activity of amikacin and capreomycin in patients whose baseline DST~          results demonstrate susceptibility to either of these two drugs and resistance to~          kanamycin.~        6. The genetic mutations associated with both in vivo and in vitro drug resistance and~          bactericidal activity.~      To achieve these objectives the investigators propose an innovative variation on early~     bactericidal activity (EBA) study methodology. Patients at risk for MDR TB will be screened~     for RMP resistance and INH resistance using molecular assays. In those with RMP-resistant or~     INH-resistant TB, the investigators will quickly perform phenotypic DSTs using the direct~     method in the Bactec Mycobacterium Growth Indicator Tube (MGIT) 960 system, so results will~     be available within 14-21 days. If the DST results show, for example, RMP resistance but~     susceptibility to RBT, consenting patients will be treated with RBT by itself for 10 days.~     The investigators will assess its effect with serial quantitative sputum cultures. If the~     concentration of viable bacteria decreases significantly, the investigators will interpret~     this to mean the drug is having an effect. If not, the drug is ineffective. After 10 days,~     the patients will resume individualized multidrug treatment based on the full set of DST~     results.~      In case the investigators identify drugs that are effective under these conditions, the~     investigators will sequence known and putative genes associated with the action of these~     drugs for the mycobacterial isolates from these patients.~      The results would have immediate implications for treatment of MDR TB and for diagnostic~     mycobacteriology.~   "
101705|NCT02236065|"~     This open label trial is conducted to investigate the efficacy and safety of the combination~     therapy of allogeneic umbilical cord blood (UCB) and granulocyte-colony stimulating factor~     (G-CSF) for patients with brain injury or neurodegenerative disorders.~   "
101706|NCT02236052|"~     This is a multiple sites phase II trial, randomized, observer-blind, dose ranging,~     placebo-controlled study to evaluate the immunogenicity, safety, and tolerability of a single~     intramuscular injection of plant-based Seasonal VLP Quadrivalent Influenza Vaccine~     administered in elderly subjects (50 years old and more).~      A total of four hundred fifty (450) subjects will be randomized in six (6) groups of 75~     subjects to receive one injection of either a non-adjuvanted low, medium or high dose level~     of VLP, a low or high dose level of VLP of the quadrivalent VLP influenza vaccine combined~     with Alhydrogel® as adjuvant or the placebo preparation (100 millimolar (mM) phosphate buffer~     + 150 mM sodium chloride (NaCl) + 0.01% Tween 80)~   "
101707|NCT02236039|"~     The investigators are investigating the effects of traffic-related diesel exhaust on lung~     function and the immune system in those at risk for COPD. The individual will be exposed to~     either filtered air (FA) or carefully controlled levels of diesel exhaust (DE) in our~     exposure chamber. Post exposure the individual will complete a steady state exercise test.~     24h later, a procedure called bronchoscopy (whereby a thin, flexible tube is placed down the~     throat and into the lungs) will be used so that samples can be collected from the lungs.~     After 1 month the entire procedure will be repeated with the alternative exposure.~   "
101708|NCT02236026|"~     The purpose of the study is to evaluate the effect of Nestorone (NES) administered as an~     bolus injection on the corrected QT interval using Fridericia's formula (QTcF).~   "
108309|NCT02149758|"~     The hypothesis is that Etoricoxib act as an adjuvant to SRP in alleviating periodontal~     inflammation by:~        1. improving clinical periodontal parameters and,~        2. improving the salivary SOD levels.~   "
101709|NCT02236013|"~     The purpose of this study is to describe the dose limiting toxicities (DLT) and define the~     maximum tolerated dose (MTD) of ASP2215 when combined with cytarabine/idarubicin or~     daunorubicin remission induction in a 7+3 schedule. Safety and tolerability of ASP2215 will~     also be evaluated. This study will also characterize the pharmacokinetics (PK) of ASP2215~     when given in combination with cytarabine/idarubicin or cytarabine/daunorubicin remission~     induction and high-dose cytarabine (HiDAC) consolidation therapy in newly diagnosed acute~     myeloid leukemia as well as evaluate the effect of ASP2215 on the PK of cytarabine.~   "
101710|NCT02236000|"~     This study is being done for the following reasons:~        -  The study has two parts. The purpose of the first part (Phase I) of the study is to find~          out the highest dose of neratinib that can be given safely with T-DM1.~        -  The purpose of the second part of the study (Phase II) is to find out whether the dose~          of neratinib with T-DM1 determined in Phase I will keep breast cancer from getting worse~          for a period of time.~        -  In order to learn more about study therapy levels in blood and discover genetic and~          protein changes associated with cancer, the study includes special research tests using~          samples from blood and from breast tumor. Blood samples will be collected before study~          treatment, once during treatment, and after study treatment stops.~        -  In the optional part of this study, three biopsies will be performed to obtain fresh~          tumor samples from an area where your cancer has spread.~   "
101711|NCT02235987|"~     The study is designed to investigate the safety, tolerability and efficacy of DG3173 in~     untreated acromegaly patients. Twenty patients received ascending single doses of DG3173 and~     one dose of octreotide, the current gold standard of medical therapy for acromegaly, with~     each patient receiving all doses of DG3173 as well as octreotide.~   "
101712|NCT02235974|"~     To perform an exploratory single center randomized study that will form the basis for a~     larger scale, more definitive randomized clinical trial to determine the optimal time after~     stroke for intensive motor training. The investigators will perform a prospective exploratory~     study of upper extremity (UE) motor training delivered at higher than usual intensity at~     three different time points after stroke:~        -  early (initiated within 30 days)~        -  subacute/outpatient (initiated within 2-3 months)~        -  chronic (initiated within 6-9 months)~      The control group will not receive the therapy intervention during the 1-year study.~      Outcome measures will be assessed at baseline, pre-treatment, post-treatment, 6 months and~     one year after stroke onset.~      Compared to individuals randomized during the outpatient (2-3 months after stroke onset) or~     chronic (6-9 months after stroke onset) time points, participants randomized to early~     intensive motor training will show greater upper extremity motor improvement measured at one~     year post stroke.~   "
101713|NCT02235961|"~     This trial is conducted in the United States of America (USA). The aim of the trial is to~     investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the~     body) for single doses of NNC9204-0530 alone and in combination with liraglutide in~     overweight to obese but otherwise healthy male subjects.~   "
101714|NCT02235948|"~     The purpose of this study is to determine whether folic acid supplementation are effective on~     arsenic lowering in a chronic, low-level arsenic exposed population.~   "
101715|NCT02235935|"~     Diabetic retinopathy (DR) is a common complication of diabetes and is divided into non~     proliferative DR and proliferative DR. The damage is caused by either macular edema, macular~     ischemia that can be followed by vascular proliferation.~      Hyperbaric chamber treatment assists in increasing the amount of oxygen in the plasma and in~     the tissues and has been proven to be beneficial in treating different wounds in diabetic~     patients but its effect hasn't been tested in diabetic retinopathy yet.~      This study will recruit 40 diabetic patients who are scheduled for hyperbaric treatment due~     to different indications such as chronic wounds or radiation damages and who also have~     diabetic retinopathy. These patients will undergo opthalmic physical examination including~     fundus photography and OCT (Optical Coherence Tomography - optical IR retinal photography).~     Screening for these patients will be conducted at the Hyperbaric chamber at Assaf Harofe~     Medical Center for all diabetic patients prior to their first treatment.~   "
101716|NCT02235922|"~     The purpose of this study is to analyze the effects of a dual task protocol on cognitive~     domains and functional capacity in non-sedentary older adults.~      The hypothesis of the present study is that older people undergoing to a dual task exercise~     protocol have greater benefits on cognition and functional performance, compared to a~     standard exercise protocol.~   "
101717|NCT02235909|"~     The purpose of the study is to evaluate the efficacy and safety of the study drug relative to~     an active comparator losartan which the same class of drug and is approved for use in the~     pediatric population aged 6 years and older. Approximately 260 subjects will participate in a~     6-week, double-blind, randomized, treatment phase, followed by a 2-week, double-blind,~     randomized placebo-controlled withdrawal phase. This study also includes a 44-week,~     open-label extension (OL Phase) in which all subjects will receive AZM and other~     antihypertensive medications (if needed) in order to reach an optimal blood pressure. Blood~     pressure will be assessed in the clinic throughout the study, and subjects may also~     participate in a 24-hour ambulatory blood pressure monitoring (ABPM) procedure at baseline,~     at the end of the DB Phase and at the end of the OL Phase.~   "
101718|NCT02235896|"~     The ultimate goal of our partnership with local African-American churches is to implement an~     effective, multi-component intervention to increase awareness of the critical importance of~     healthy lifestyle in the prevention of cardiovascular disease (CVD). We will utilize the~     American Heart Association (AHA) prevention strategy, &quot;Life's Simple 7&quot; to address~     the major risk factors for CVD: diet, smoking, physical inactivity, hypertension, diabetes,~     cholesterol and obesity in order to improve overall cardiovascular health. Our main strategy~     consists of a community-based participatory research approach that involves focus groups to~     assess participant knowledge and beliefs about CVD risk factors prior to program initiation.~     We will also determine participant dietary and exercise practices, knowledge and perceptions~     related to healthy lifestyle and chronic diseases, demographic/health status information,~     health care utilization, biometrics (weight, blood pressure, blood tests for glucose and~     cholesterol, etc.) and attitudes about medical research at baseline, program completion and~     6-month follow-up.~   "
103914|NCT02207205|"~     1. Determine if there is any difference between the whole blood clotting time results~          obtained from blood drawn from indwelling catheters and direct venipuncture~        2. Determine the intra-subject variability in both procedures~   "
101719|NCT02235883|"~     The objective of the HEART Study is to develop a multiscale model of the coronary circulation~     based on multimodal imaging data (angiography, echocardiography). The predictive~     comprehensive multi-scale model, developed during this proof-of-concept study, will be used~     for analyzing functional aspects of coronary artery disease. Model validation is performed~     against invasive measurements~   "
101720|NCT02235870|"~     This pivotal trial of the Obalon Balloon System is intended to generate safety and~     effectiveness data required to support a future marketing application. The trial has been~     designed to evaluate a 6-month use of the Obalon Balloon System as an adjunct to a nutrition~     and lifestyle behavior modification program.~      Weight loss will be evaluated after the 6-month course to determine if a specific predefined~     superiority margin can be achieved in the device group compared to a sham-control group.~   "
101721|NCT02235857|"~     Liposorber® LA-15 System is a blood purification therapy that selectively removes malignant~     lipoproteins including low density lipoprotein from circulating blood flow and rapidly~     reduces the plasma cholesterol level. The system was originally developed for the treatment~     of patients with serious dyslipidemia such as familial hypercholesterolemia and then applied~     to improve the dyslipidemia, a common complication of nephrotic syndrome and found to bring~     about improvement not only with the dyslipidemic condition but the nephrotic condition (e.g,~     proteinuria and hypoproteinemia).~      Although the definitive mechanism by which the system may relieve nephrotic syndrome is~     unknown, it has been recognized as one of alternative therapies for refractory nephrotic~     syndrome including focal segmental glomerulosclerosis (FSGS) in Japan and referred in the~     Guidelines for the Treatment of Nephrotic Syndrome endorsed by The Japanese Society of~     Nephrology.~      This study is conducted as a post approval study imposed by Humanitarian Device Exemption~     (HDE) order to confirm the safety and efficacy of the Liposorber® LA-15 System in the~     treatment of drug-resistant pediatric primary FSGS.~   "
101722|NCT02235844|"~     This research study is designed to evaluate the effects of human umbilical cord mesenchymal~     stem cells (UC-MSCs), on Duchenne's muscular dystrophy (DMD). The potential muscle~     regenerative and anti-inflammatory properties of UC MSCs position them as a possible~     treatment option for DMD. Both of these properties could lead to potential benefits for a DMD~     patient.~   "
101723|NCT02235831|"~     The purpose of this study is to evaluate the visual performance of DAILIES® Aqua Comfort~     Plus® (DACP) MF contact lens using new objective measurements.~   "
101724|NCT02235818|"~     The purpose of this study was to compare the immediate efficacy of Counterforce brace versus~     kinesiotaping on patients with lateral epicondylosis/tennis elbow with respect to a~     repetitive physical task. The investigators hypothesized that there would be difference in~     the outcomes with respect to interventions and activity. Patient came for one hour long~     Single occasion testing session and were not followed up after the testing was complete.~   "
101725|NCT02235805|"~     Observational epidemiologic studies have observed an inverse relationship between daily~     dietary magnesium intake and blood pressure (BP). Except for BP, magnesium may also~     beneficially affect other cardiovascular risk markers. Whether all these effects translate~     into improved vascular function is not known. Different vascular function markers at various~     stages on the pathway between diet and disease exist. One of these markers, vascular~     stiffness, is closely related to the process of atherosclerosis, an independent~     cardiovascular risk factor, and predictive of future cardiovascular events and mortality. To~     examine the integrated effects of interventions on cardiovascular risk, vascular stiffness~     may therefore serve as a marker at the later stage of cardiovascular disease development.~      Therefore, it is imperative to examine in a 24-week, randomized, double-blind,~     placebo-controlled, two-way parallel-group human intervention study, the effect of magnesium~     on vascular stiffness. Focus will be on carotid-femoral pulse wave velocity (PWV), the gold~     standard for the evaluation of vascular elasticity, to quantify vascular stiffness. Urinary~     excretion of magnesium will be used to assess dietary magnesium uptake. Furthermore, time~     courses of an increased magnesium intake on changes in BP, other markers reflecting vascular~     function, and plasma biomarkers related to low-grade inflammation and vascular activity will~     be measured to unravel possible cause-effect relationships.~   "
101726|NCT02235792|"~     This study is designed to evaluate the high-frequency range deep brain oscillations (HFO) as~     pathologic markers in patients undergoing deep brain stimulation for epilepsy or Parkinson~     disease. Newly developed technology allows for the chronic recording of these brain signals~     at the same time as clinical stimulation is occuring. We will learn both whether these HFO~     correlate with disease activity and whether the HFO change in response to ongoing stimulation~     (potentially giving insight into the underlying mechanism of action of DBS).~   "
101727|NCT02235779|"~     Evaluation of diagnostic yield, feasibility and safety of transbronchial lung cryobiopsies~     done via bronchoscopy in the investigation of interstitial lung disease in comparison with~     videothoracoscopy-assisted surgical lung biopsy.~   "
101728|NCT02235766|"~     Purpose of the observational study is to assess the capability of a satellite~     tele-echocardiography (STE) system to acquire and transmit echocardiographic images and clips~     to an echocardiographic core laboratory (ECL) in a real time mode without loss of quality.~     Additionally the prognostic efficacy of specific echo parameters in the cardiac~     resynchronization therapy response will be evaluated.~   "
101729|NCT02235753|"~     Despite the well-known health benefits of physical exercise in the prevention of chronic~     diseases, less attention has been focused on the use of physical exercise as an essential~     part of good treatment for chronic disease. The aims of the study are to investigate the~     feasibility, medical effects, cost-effectiveness, and social perspectives of the~     individualized exercise-based rehabilitation [2 different high-intensity training (HIT)~     protocols combined with usual care (UC)] after acute coronary artery disease (CAD) event. The~     medical aim is to study mediating mechanisms of the physiological, biochemical and molecular~     effects of exercise training on the clinical outcomes. The aim of the health-economic~     evaluation is to assess the changes in the Health-Related Quality of Life (HRQL) and health~     care related costs for estimating the cost-effectiveness of HIT-based exercise~     rehabilitation. The purpose of the sociological analysis is to find out the social processes~     which make possible the emergence of the desired welfare effects.~   "
103956|NCT02206659|"~     To assess the trough/peak ratio of 40 mg Telmisartan tablet by ambulatory blood pressure~     monitoring in Chinese patients with mild to moderate essential hypertension~   "
101730|NCT02235740|"~     This open-label, 2-part Phase I/ randomized Phase II multi-center study is conducted to~     evaluate the safety, tolerability, pharmacokinetics (PK), and clinical activity of~     afuresertib in combination with carfilzomib versus carfilzomib alone, in subjects with~     relapsed/refractory MM. Part 1 will evaluate 2 dose levels (125 milligrams [mg] and 150 mg of~     afuresertib) in 16 subjects (approximately 8 in each parallel arm) to determine an optimal~     dose of afuresertib for administration in combination with carfilzomib in Part 2. If neither~     of these dose levels are tolerated, an additional dose level of 100mg of afursertib in~     combination with carfilzomib may be explored in approximately 8 additional subjects. Part 2~     was to investigate the safety, and clinical activity of the combination of afuresertib with~     carfilzomib (determined in Part 1) compared to carfilzomib alone, in approximately 100~     subjects (50 in each parallel arm), however the study was terminated after the~     discontinuation of the single subject following the transition of the afuresertib development~     program from GSK to Novartis. The reason for the study termination is that the protocol~     defined study treatment was no longer aligned with the evolving standard of care.~   "
101731|NCT02235727|"~     A Single Dose Study of GBR 900 in Healthy Volunteers.~   "
101732|NCT02235714|"~     The purpose of this study is to obtain markers of airway inflammation from the exhaled breath~     condensate (the moisture in exhaled air) for comparison to blood based markers. These markers~     will be compared in tetraplegic, asthmatic and able-bodied control groups. Additionally, lung~     function testing will be performed, and the associations between breath condensate and blood~     markers and pulmonary function explored between groups.~   "
101733|NCT02235701|"~     This is a Phase 1 open-label study to study the safety and activity of aldoxorubicin with~     ifosfamide/mesna in subjects with metastatic, advanced, unresectable soft tissue sarcoma.~   "
101734|NCT02235688|"~     This is a Phase 1 study to investigate the safety and activity of aldoxorubicin plus~     gemcitabine in Subjects with solid tumors.~   "
101735|NCT02235675|"~     Multi-center study to optimize below the knee (BTK) balloon angioplasty results by creating~     tissue apposition in peripheral arteries with Reference Vessel Diameter's (RVD) ranging from~     1.5mm to 4.5mm.~   "
101736|NCT02235662|"~     The purpose of the study is to evaluate the safety of the TFV/LNG intravaginal ring (IVR),~     TFV-only IVR, and placebo IVR, evaluate pharmacokinetics (PK) of TFV and LNG, evaluate~     pharmacodynamic (PD) surrogates of contraceptive efficacy of LNG, and to evaluate~     acceptability of the IVRs.~   "
101737|NCT02235649|"~     Reduced social and community functioning is a predominant and enduring feature in people~     experiencing severe mental illness such as psychosis. The large majority of interventions~     (mostly pharmacological) target the so called positive symptoms (e.g. hallucinations and~     delusions) but poorly address functional and social consequences of the illness.~      This study attempts to fill this gap by assessing the feasibility and acceptability of a~     psychological intervention targeting social cognition deficit in people with psychosis. The~     intervention is a group psychological treatment facilitated by a clinical psychologist~     targeting competencies such as emotion recognition, social situation appraisal and guessing~     people's intentions and mental states. The group therapy takes advantage of audiovisual~     material to illustrate strategies and thinking styles that may help participants to overcome~     difficulties in social settings.~      A second objective of this study is to test a new method to measure social cognition. Recent~     research showed that interview and performance based tests are poorly associated with every~     day activity of people with schizophrenia. This study is planning to evaluate the feasibility~     of new assessment methods for social cognition in everyday life using portable electronic~     devices (Experience Sampling Method and an activity watch). These devices will be carried by~     participants in their everyday life and will ask about feelings and levels of social~     activities at random times and record basic physiological and activity levels.~   "
101738|NCT02235636|"~     To compare the performance of surgical suturing using Da Vinci Robotic Surgical System and~     conventional Laparoscopic surgical suturing among novice~   "
101739|NCT02235623|"~     This is a randomized trial designed to evaluate testicular outcomes after a single stage~     versus a two-stage surgical procedure to fix an undescended, one-sided testicle located in~     the abdomen. Also to determine and compare the costs, surgical complications and the health~     related quality of life for the two procedures. Testicular outcomes will be measured using a~     scrotal ultrasound 6-12 months after the procedure (after the second stage procedure for~     those randomized to a 2 stage surgery).~   "
101740|NCT02235610|"~     The overall objective of this study is to evaluate the clinical effectiveness of the novel~     technique of donor EVLP in increasing lung transplant activity by allowing previously~     unusable donor lungs to be safely used in clinical lung transplantation. Furthermore, to~     utilize the EVLP technique in research settings thus allowing the evaluation of inflammatory~     molecules (biomarkers) that would benefit a successful pre-conditioning and increase~     knowledge of the lungs inflammatory response before transplantation.~   "
101741|NCT02235597|"~     The investigators seek to improve health systems so underserved people, patients without~     insurance, Medicaid, Medicare, as well as self pay and their caregivers can better access~     health care for common problems and acute care needs (same day appointments).~   "
101742|NCT02235584|"~     In this study we examine whether inducing insulin resistance by dexamethasone in healthy~     volunteers will lead to a decreased insulinotropic effect of the hormones GLP-1 and GIP.~   "
101759|NCT02235363|"~     In facial rejuvenating surgery, the current trend calls for fewer and less noticeable scars~     with desired results. Especially to improve the jowls and nasolabial folds, the thread lift~     is a simple and inexpensive technique for patients who do not wish to undergo the typical~     facelift surgery, but the weak points of it are less effective and shorter duration than the~     conventional facelift.The investigators propose the new method of the thread lifting the~     subdermal and subcutaneous layer with a fiberoptic needle by use of the retaining ligaments~     with two fixation points on both temporal fascia and retaining ligaments. For the~     intraoperative evaluation the tensiometer was applied and for the postoperative evaluation~     the FACE-Q applied.~   "
101788|NCT02234986|"~     The purpose of the study is to determine whether once-daily dosing with ENMD-2076 will be a~     safe and effective treatment in patients with FLC. Safety will be measured by looking at the~     adverse events that may happen and the efficacy will look at the progression of the disease~     over time.~   "
101743|NCT02235571|"~     The investigators developed iChoose Kidney -- a shared decision-making support tool~     accessible through iPad, iPhone, or the web -- to provide ESRD patients and their providers~     with a simple, standardized, easily accessible, statistically robust tool for use in the~     clinic to guide patient education and healthcare decision-making about treatment options of~     dialysis or kidney transplantation. The iChoose Kidney decision aid provides patients with~     estimates of their individualized 1 and 3-year risks of mortality on dialysis vs.~     transplantation, based on previous national data. The tool has the potential to improve~     communication and decision-making between patients and their healthcare providers and improve~     access to kidney transplantation among patients with ESRD.~      This will be a two-arm, randomized study, and will be conducted at 3 large transplant centers~     with diverse patient populations. One group of patients will receive standard education alone~     during their scheduled transplant evaluation. The second group will receive the standard~     education as well have the provider use the iChoose Kidney aid with them. The project~     timeline will be a total of 24 months inclusive of enrollment, follow-up, data analysis, and~     outcome evaluation.~      This study will assess how well the iChoose decision aid works in improving patient~     knowledge, preferences for treatment, and patient access to transplant. The study will also~     assess whether providers find the tool useful for providing ways to share information with~     patients about ways to treat their kidney disease.~   "
101744|NCT02235558|"~     The purpose of this study is to determine whether super-selective intra-arterial~     administration of verapamil immediately following successful intra-arterial thrombolysis is~     safe as a potential neuroprotective agent. Standard procedures are cerebral angiography and~     intra-arterial thrombolysis (intra-arterial administration of tPA and/or mechanical~     thrombectomy). Experimental procedure is superselective injection of verapamil~     intra-arterially.~   "
101745|NCT02235545|"~     The purpose of this post approval study is to characterize the chronic performance of the SJM~     Optisure family of HV leads in patients.~   "
101746|NCT02235532|"~     This study aimed to assess the effects of Aloe Vera toothpaste on dental plaque and~     gingivitis.~      The single-blind cross-over clinical trial was conducted on 20 dental students (10 males and~     10 females with a mean age of 24.5±4 yrs.) with gingivitis. Students were randomly divided~     into 2 groups. The first group used Aloe Vera toothpaste for 30 days. A 2-week wash-out~     period was allowed and then subjects used fluoride toothpaste for the next 30 days . This~     order was reversed in group 2.~   "
101747|NCT02235519|"~     The goal of this study is to build a mathematical model to explain the effect of two doses of~     azilsartan (40 and 80 mg) upon metabolic (insulin resistance, glucose) and inflammatory~     parameters (cytokines) in function of metabolic strata like obesity, type 2 diabetes~     mellitus, hypertension and their combinations.~   "
101748|NCT02235506|"~     The investigators compared continuous epidural infusion with combined continuous femoral and~     single-shot sciatic nerve blocks. The primary outcome was the incidence of side effects, and~     secondary outcomes were pain relief, motor blockade,morphine consumption, and rehabilitation~     indices.~   "
101749|NCT02235493|"~     The purpose of this study is to characterize the natural history of HPP in patients with~     Juvenile-onset HPP who served as historical controls in ENB-006-09.~   "
101750|NCT02235480|"~     The aim of this study is to determine the efficacy and safety of topical application of the~     gel compared to placebo in nail psoriasis.~   "
101751|NCT02235467|"~     This is a Brazilian multisite study to test the efficacy of an Applied Behavior Analysis~     (ABA) parent training using video modeling to teach parents of children with Autism~     techniques to apply to their children in order to improve eye contact and joint attention~     behaviors.~      Our hypothesis is that children with Autism whose parents will be trained by videomodeling~     will have better eye contact and joint attention behaviors compared to children with Autism~     whose parents will not be trained.~   "
101752|NCT02235454|"~     The investigators prospectively evaluate the new glaucoma premium edition (GMPE) software for~     spectral domain optical coherence tomography (SDOCT) and if this software is superior to the~     conventional one that is currently used for SDOCT.~   "
101753|NCT02235441|"~     There is growing evidence of the integral role of exercise following cancer treatment.~     Randomized trials show that exercise improves post treatment symptoms and quality of life in~     breast and prostate cancer patients.Regular exercise reduces cancer specific and all cause~     mortality for patients with breast, prostate, brain or colorectal cancer. Nearly a 40-50%~     relative risk reduction in cancer specific death and 20-50% relative risk reduction in all~     cause mortality have been reported with exercise. At present it is unknown if preclinical~     pleiotropic effects on tumors through aerobic exercise are clinically relevant. Before~     launching into further studies of exercise training on changes in tumor hypoxia and response~     to CRT in rectal cancer patients, it is first important to understand: 1. Whether measures of~     exercise exposure (i.e., exercise capacity and self-reported exercise behavior) are~     associated with markers of tumor hypoxia at diagnosis (prior to initiation of CRT) and 2.~     Whether changes in measures of exercise exposure over the course of CRT are related to~     changes in tumor hypoxia and response to CRT.~   "
101754|NCT02235428|"~     To determine whether addition of ipratropium bromide to salbutamol nebulisations produces~     significantly greater bronchodilation in young children presenting to an emergency department~     with an acute attack of asthma~   "
101755|NCT02235415|"~     Study of the efficacy and tolerance of Motens® (lacidipine) in patients with essential~     hypertension. To obtain information on the dosage used in practice and the tolerance at the~     start of treatment (12 weeks)~   "
101756|NCT02235402|"~     The aim of this study is to compare the effects of lacidipine on markers of platelet~     activation and other rheological factors in hypertensive patients with those of~     bendrofluazide~   "
101757|NCT02235389|"~     The general aim of this study was to assess the feasibility of treating acute myocardial~     infarction (AMI) by physician-directed pre-hospital thrombosis, using accelerated alteplase~     (Actilyse®) and a diagnostic technique involving remote electrocardiogram (ECG) acquisition~     by paramedics~   "
101758|NCT02235376|"~     Identification of criteria associated with extubation failure of brain injured patients.~     Elaboration of a prognostic score of extubation failure of brain injured patients.~   "
108310|NCT02149745|"~     The purpose of this study is to find if we can shorten the recovery time by calling the~     patient's name during anesthesia reversal.~   "
101760|NCT02235350|"~     Epidemiological studies report that 85% of stroke survivors show hemiparesis and a percentage~     ranging from 55% to 75% report upper limb functional impairment. Early rehabilitation in~     stroke patients with motor disorders can be effective to restore the affected function and to~     improve the performance of daily activities. Up to now, different methods and techniques have~     been used to recover motor functions in stroke patients. However, none of these has been~     conclusively proven to be more effective than the others. The clinical benefits induced by~     motor rehabilitation are closely related to neuroplasticity. The main aim of the present~     study is to assess the efficacy of action observation treatment, based on Mirror Neuron~     System (MNS), in the rehabilitation of upper limb motor functions in acute stroke patients.~     The study will also aim at assessing neuroplasticity within areas belonging to the MNS~     through functional magnetic resonance (fMRI).~   "
101761|NCT02235337|"~     The purpose of this study is to investigate the effectiveness of riboflavin to decrease the~     duration of time for a student-athlete to return to participation in sports after a sports~     related concussion.~   "
101762|NCT02235324|"~     This phase II trial studies how long it takes colorectal cancer resistant to standard~     treatment to grow while receiving treatment with ziv-aflibercept, and how well adding~     fluorouracil and leucovorin calcium to ziv-aflibercept works in treating patients with stage~     IV colorectal cancer after they progress on ziv-aflibercept alone. Ziv-aflibercept may stop~     the growth of colorectal cancer by blocking the formation of tumor blood vessels.~     Fluorouracil and leucovorin calcium are drugs used in chemotherapy. Fluorouracil works to~     stop the growth of tumors cells by preventing the cells from growing and dividing. Leucovorin~     calcium helps fluorouracil work better. Adding fluorouracil and leucovorin calcium to~     ziv-aflibercept may be an effective treatment for patients who progress on ziv-aflibercept~     alone.~   "
101763|NCT02235311|"~     Despite recommendations from clinical practice guidelines to discharge patients from the~     hospital on once daily proton pump inhibitors after acute management of UGIB, clinical~     practice is to use twice daily proton pump inhibitor therapy. The objective of this study~     will be to assess whether or not once daily pantoprazole is non-inferior to twice daily~     pantoprazole in ulcer healing with a dose of once daily versus twice daily proton-pump~     inhibitor following an upper gastrointestinal bleed. Additionally, this study will observe~     for any potential difference in safety for once daily versus twice daily proton pump~     inhibitors.~   "
101764|NCT02235298|"~     Dapagliflozin is a new and emerging anti-diabetes medication. Dapagliflozin is a selective~     sodium-glucose cotransporter 2 (SGLT2) inhibitor, reduces hyperglycemia in patients with type~     2 diabetes mellitus (T2DM) by increasing urinary glucose excretion, and weight loss is a~     consistent associated finding. Because dapagliflozin increases urinary glucose excretion,~     weight loss could result from reduced body fat secondary to caloric loss or from fluid loss~     secondary to osmotic diuresis or from a combination of both factors. Nevertheless, whether~     Dapaglifozin may cause a reduction in visceral fat is unknown.~      Hence, in this study the investigators would like to test the hypothesis that Dapaglifozin~     causes a rapid and significant reduction of the epicardial fat, the visceral fat of the~     heart, in type 2 diabetic patients.~      This hypothesis would be tested in a prospective interventional study in 100 overweight or~     obese type 2 diabetes subjects.~   "
101765|NCT02235285|"~     In 162 Asian patients, primary breast augmentations were performed by a single surgeon during~     5 years. The purpose of this study evaluates Asian outcomes in primary breast augmentation~     using single antibiotic breast irrigation by a single surgeon's practice and examines the~     comparison of Asian and Western outcomes in primary breast augmentation.~   "
101766|NCT02235272|"~     The purpose of this study is to evaluate the clinical efficacy and safety of XG-102 (900µg)~     compared to vehicle in the treatment of subjects with inflammation and pain following~     cataract surgery.~   "
101767|NCT02235259|"~     The objective of this study is to assess the safety and efficacy of XG-104 Ophthalmic~     Solution compared to placebo for the treatment of the signs and symptoms of dry eye after a 4~     week Three Times a Day (TID) treatment period~   "
101768|NCT02235246|"~     Endoscopic submucosal dissection (ESD) is an effective treatment for early gastric cancer or~     premalignant lesions in the stomach. ESD enables en bloc resection of gastrointestinal~     neoplasms, increases the rates of histologically complete resections, and also reduces local~     recurrence rates. Despite these advantages, ESD is thought to induce various complications.~     Wellknown ESD-related complications include perforation, postoperative bleeding, or~     stricture. In addition, minor adverse events after ESD are also commonly noticed. Pain is one~     of these frequently noticed minor ESD related complications, is the main reason for~     prolongation of the hospital stay, and is related to patients' compliance; however, there is~     a tendency to neglect or underestimate post-ESD pain. The causes of pain associated with ESD~     are thought to be associated with transmural burn or transmural air leak. Some studies have~     tried to control localized pain during and after ESD using local lidocaine, single dose~     postoperative intravenous dexamethasone or a transdermal fentanyl patch. Magnesium has been~     reported to alter the perception and duration of pain and produce important analgesic~     effects. It is included the suppression of neuropathic pain, potentiation of morphine~     analgesia, and attenuation of morphine tolerance. Although the exact mechanism is not yet~     fully understood, the analgesic properties of magnesium are believed to stem from regulation~     of calcium influx into the cell and antagonism of N-methyl-D-aspartate receptors in the~     central nervous system. Also, magnesium may prolong neuromuscular blockade after~     administration of neuromuscular blocking drugs, increase sedation and contribute to serious~     cardiac morbidity. And magnesium as a hypotensive anaesthesia technique supply objectively~     better operative field, reduction in the duration of surgery and reduced blood loss. There~     have been no previous trials on the use of magnesium specifically for pain control following~     ESD. Thus, the purpose of this study was to assess the efficacy of intravenous magnesium for~     pain relief after ESD.~   "
101769|NCT02235233|"~     This study is designed to investigate the effect of NASH (non-alcoholic steatohepatitis) on~     the disposition of 99mTechnetium(Tc)-mebrofenin and to relate changes in 99mTc-mebrofenin~     disposition to differences in the bile acid profile and Fibroscan Fibrosis Score of healthy~     subjects compared to patients with NASH.~   "
101770|NCT02235220|"~     In this study it is to be evaluated wether a restoration with composite resin fillings to~     reestablish a canine guidance will reduce masticatory muscle activity in patients with~     bruxism.~   "
101771|NCT02235207|"~     The purpose of the study is to investigate the effectiveness of Fustra® exercise program in~     relieving recurrent pain in the neck or/and back, and thus improve quality of life in female~     and male office workers. The hypothesis is that neuromuscular exercise will improve control~     of posture and movement, neck shoulder and trunk flexibility, trunk muscular endurance and~     leg strength, and thus decrease intensity of pain by 30% compared to non-exercise group. In~     addition, financial feasibility of the exercise program and effects of training on quality of~     life and perceived work ability are studied.~   "
101772|NCT02235194|"~     It has previously been shown in healthy overweight subjects, that table water including a~     defined amount of amino acids and chromium can decrease the postprandial glucose and insulin~     response. In this study, the effect of this table water on glucose excursions after a test~     meal containing a defined amount of available carbohydrates, protein and fat will be studied~     in patients with early type 2 diabetes or prediabetes according to guidelines that are~     treated with dietary measures or metformin only. The study will be conducted in a cross -over~     design, double blinded and placebo controlled including 20 participants. The primary endpoint~     of the study is the incremental area under the curve for plasma glucose (iAUCgluc) within 180~     minutes after ingestion of the meal.~   "
101773|NCT02235181|"~     This study aims to determine whether the Arabin cervical pessary prevents preterm birth in~     women with a twin pregnancy and a short cervix.~   "
101774|NCT02235168|"~     To evaluate the effect of a rollator on 6 Minute Walking Test (6MWT) in elderly people.~   "
101775|NCT02235155|"~     The primary goal is to examine the efficacy and feasibility of a mifepristone-misoprostol~     medical abortion regimen in terminating pregnancies 13-22 weeks in Uzbekistan.~   "
101776|NCT02235142|"~     Open study to make a comparison between hypogonadism and euogonadism patients regarding the~     severity of prostate cancer. The purpose of this study is to determine the importance of the~     relationship between the hormonal status and the type of the tumor at the time of surgical~     intervention as well as follow up of the patients.~   "
101777|NCT02235129|"~     To compare the relationship between breath-hold time and the distance in a Six Minute Walking~     Test in chronic obstructive pulmonary disease population.~   "
101778|NCT02235116|"~     This is a cross-sectional survey distributed to a convenience sample of patients in a waiting~     room of an academic dermatology clinic. The survey assesses patient experiences with full~     body skin exams and attitudes towards full body skin exams. The survey is designed to help~     investigators better understand how many patients are not getting full body skin exams, why~     this may be occurring, and what types of interventions may be enacted to increase the number~     of patients getting full body skin exams.~   "
101779|NCT02235103|"~     Recent research has revealed that subtle abnormalities can be found in sperm samples that~     seem to be normal with conventional analysis techniques. The DNA in the sperm heads is~     sometimes fragmented and this may be the reason why couples with a diagnosis of unexplained~     infertility do not achieve pregnancy.~      We are planning a study to examine the incidence of DNA fragmentation in the sperm of couples~     with previously unexplained infertility. In a first treatment cycle with intra-uterine~     insemination the percentage of DNA fragmentation in sperm will be measured. Afterwards the~     results of the patients who are pregnant will be compared with those of the not pregnant~     ones. We expect to find differences between both groups.~      100 patients will be included in the study.~   "
101780|NCT02235090|"~     Clinical trials organization in several neuromuscular disorders (NMD) has some specific~     issues. Nonambulant status and difficulties with transportation are among them. Moreover a~     lot of patients with NMD have so poor condition that even short transportation is able to~     worse it. Such situation forces researchers to limit a region of recruitment for clinical~     trials and to exclude from trials more severe subgroup of patients, which cause additional~     issues especially for rare diseases.~      The purpose of this study is to prove hypothesis about possibility to reliably monitor~     patient condition remotely, without trial site visiting. Visit-free study design is~     potentially able to widen eligible patient population and to decrease patient dropout rate as~     well as burden of numerous assessments. Meanwhile assessment frequency could be increased~     enabling monitoring of short fluctuations in patients' condition.~      Spinal muscular atrophy (SMA) is a rare neuromuscular condition to which all mentioned above~     issues are completely applicable. Direct current stimulation (DCS) of neural structures is~     well studied and safe intervention, however, its effects on SMA patients' strength and~     durability has not been reported for today. The investigators suppose that investigation of~     DCS action in SMA patient population is an adequate model for visit-free design feasibility,~     reliability and sensitivity evaluation.~   "
101781|NCT02235077|"~     The primary objective of this study is to test the hypothesis that high-dose spironolactone~     will lead to greater proportional reduction in NT-proBNP levels from randomization to 96~     hours over standard of care.~   "
101782|NCT02235064|"~     The purpose of this project is to assess the effectiveness of preventative antidepressants~     immediately following delivery on postpartum depression rates in women at high risk due to~     prior history of depression or postpartum depression.~   "
101783|NCT02235051|"~     This randomized pilot trial studies how well an exercise intervention works in preventing~     breast cancer from coming back in postmenopausal breast cancer survivors. Regular exercise~     may be able to train the body to repair deoxyribonucleic acid (DNA) more efficiently and to~     respond to inflammation more proficiently, helping to prevent primary and recurrent breast~     cancer.~   "
101784|NCT02235038|"~     This study will evaluate a potential physiologic mechanism underlying the effects of dietary~     composition on control of body weight~   "
101785|NCT02235025|"~     The current definition of chronic obstructive pulmonary disease (COPD) is based on the~     presence of persistent airflow obstruction assessed by spirometry. About half of the subjects~     with mild COPD (i.e. reduced forced expiratory volume in one second (FEV1) on forced vital~     capacity (FVC) ratio along with normal FEV1] are asymptomatic. Subjects with symptomatic mild~     COPD have reduced exercise tolerance and abnormal dynamic ventilatory mechanics compared to~     healthy subjects. The physiological and perceptual responses to exercise of subjects with~     asymptomatic mild COPD are currently unknown.~      The purpose of this study is to assess exercise tolerance, ventilatory constraints on tidal~     volume expansion and dyspnoea in asymptomatic mild COPD subjects undergoing incremental cycle~     cardiopulmonary exercise testing (CPET) to the limit of tolerance compared with symptomatic~     mild COPD and healthy controls.~   "
101786|NCT02235012|"~     Characterise cognitive biases resulting from low dose ketamine infusion, used as a~     pharmacological model of psychosis.~      Our assumption is that low dose ketamine results in reasoning biases by impairing the way~     uncertainty is monitored and taken into account for decision making.~   "
101787|NCT02234999|"~     To evaluate the metabolism and excretion of [14C]-CC-122 in healthy male subjects~   "
114915|NCT02063295|"~     The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of~     beloranib in obese subjects with hypothalamic injury.~   "
101789|NCT02234973|"~     Context: Indigenous peoples experience higher prevalence rates of diabetes and worse health~     outcomes compared to the general population because of a wide array of factors: social~     determinants of health, lifestyle, genetic susceptibility, and historic-political and~     psycho-social factors. Barriers to care that are unique to First Nations communities~     exacerbate the problem with fragmented healthcare, poor chronic disease management,~     healthcare staff turnover, and limited, or non-existent, surveillance.~      Program: The TransFORmation of IndiGEnous PrimAry HEAlthcare Delivery (FORGE AHEAD) research~     program aims to develop and evaluate community-driven, culturally relevant, primary~     healthcare models that enhance chronic disease prevention and management in First Nations~     communities in Canada. Participants will consist of Indigenous community and clinic team~     members that will take part in multiple interrelated projects including community profiling,~     readiness consultations, diabetes registry and surveillance, and quality improvement~     workshops and action periods.~      Design: This mixed-method pre-post observational study will capture: 1) diabetes clinical~     process and outcomes measures, 2) details about community-driven innovations, and 3)~     knowledge about the experience and cost of attempting to improve primary delivery in~     individual Indigenous communities.~      Intervention/Instrument: Survey, literature review, 15 month intervention (readiness~     consultations, implementation and maintenance of a registry and surveillance system,~     community and clinic focused quality improvement workshops), interviews.~      Measures: Primary- mean A1C of patients with diabetes (A1C ≥ 8.0% at baseline);~     Secondary-clinical process and outcome measures, change in stage of readiness, description of~     participation and innovation facilitators and barriers.~      Policy Implications: The outcomes of this research program have the potential to~     significantly affect future policy decisions pertaining to chronic disease care in First~     Nations communities. Policy recommendations will be made to help support Indigenous~     communities in adopting successful innovations to help address issues related to diabetes and~     other chronic illnesses. The community-driven innovations developed in FORGE AHEAD and the~     subsequent policy decisions may enhance chronic disease prevention and management for~     Indigenous peoples across the country.~   "
101790|NCT02234960|"~     The aim of this non-interventional, prospective, observational study is to assess the~     effectiveness and tolerability of RoActemra (tocilizumab) used as a first-line biologic~     treatment in participants with moderate to severe active RA who are inadequate responders to~     disease-modifying antirheumatic drugs (DMARDs), or participants who are intolerant to DMARDs,~     in a routine clinical practice setting in Poland. The length of the entire study will be 24~     months.~   "
101791|NCT02234947|"~     Type 1 diabetes (T1D) is characterized by a progressive destruction of insulin producing beta~     cells, resulting in a lifelong dependence on exogenous insulin. While beta cells make up less~     than 1% of the pancreas, studies have demonstrated that T1D is associated with a marked~     reduction of pancreatic mass at diagnosis and as the disease progresses. As such, if~     pancreatic volume assessment, by ultrasonography (US) or MRI (Magnetic Resonance Imaging),~     could be utilized as a marker of beta cell function in high risk patients, non-invasive~     pancreatic imaging could become an important part of staging diabetes risk. As such, the~     primary goal of this study is to measure pancreatic volume and compare differences in volume~     between new onset T1D patients, antibody positive subjects at risk for diabetes, antibody~     negative individuals, and healthy controls.~   "
101792|NCT02234934|"~     Chronic Granulomatous Disease (CGD) is an inherited immunodeficiency disorder which results~     from defects that prevent white blood cells from effectively killing bacteria, fungi and~     other microorganisms. Chronic granulomatous inflammation may compromise vital organs and~     account for additional morbidity. CGD is thought to affect approximately 1 in 200,000~     persons, although the real incidence might be higher due to under-diagnosis of milder~     phenotypes.~      The first gene therapy approaches in X-CGD have shown that effective gene therapy requires~     bone-marrow (BM) conditioning with chemotherapy to make space for the gene-modified cells to~     engraft. These studies demonstrated that transplantation of gene modified stem cells led to~     production of white blood cells that could clear existing infections. However, some trials~     using mouse-derived retroviral vectors were complicated by the development of myelodysplasia~     and leukemia-like growth of blood cells. This trial will evaluate a new lentiviral vector~     that may be able to correct the defect, but have much lower risk for the complication.~      This study is a prospective non-controlled, non-randomized Phase I/II clinical trial to~     assess the safety, feasibility and efficacy of cellular gene therapy in patients with chronic~     granulomatous disease using transplantation of autologous bone marrow CD34+ cells transduced~     ex vivo by the G1XCGD lentiviral vector containing the human CGD gene. Primary objectives~     include evaluation of safety and evaluation of efficacy by biochemical and functional~     reconstitution in progeny of engrafted cells and stability at 12 months. Secondary objectives~     include evaluation of clinical efficacy, longitudinal evaluation of clinical effect in terms~     of augmented immunity against bacterial and fungal infection, transduction of CD34+~     hematopoietic cells from X-CGD patients by ex vivo lentivirus-mediated gene transfer, and~     evaluation of engraftment kinetics and stability. Approximately 3-5 patients will be treated~     per site with a goal of 10 total patients to be treated with G1XCGD lentiviral vector.~   "
101793|NCT02234921|"~     This is a pilot study of the DRibble vaccine in patients with advanced prostate cancer.~   "
101794|NCT02234908|"~     This pilot project is an evaluation of the feasibility, acceptability, and cost of offering~     an economic reward, in the form of a shopping voucher, to the household contacts of index~     patients (outpatient drug-susceptible and drug-resistant TB patients) who present at the~     study clinic for TB screening and optional HIV testing, providing a reward to the index~     patients for participating, and entering index patients whose contacts do present into a~     lottery to win a prize.The effectiveness of the intervention in screening a high proportion~     of contacts will be compared to existing published data from studies of active case-finding~     through home visits and of the status quo passive case finding. If successful, this pilot~     project will create a demand for screening among high risk patients, who will be rewarded for~     identifying themselves to the healthcare system, and could prove to be an affordable~     alternative to resource-intensive home visits. It will also shift responsibility for contact~     tracing from overburdened clinic staff to those who have the most to gain from early case~     detection—the patients and their families.~   "
101795|NCT02234895|"~     Knee osteoarthritis (OA) is a widespread problem in Canada, leading to decreased quality of~     life and increased economic burden. Current research has focused on expensive, invasive~     treatments, whereas inexpensive conservative treatments have received less attention. One~     such treatment is the use of orthotics to reduce pain and increase function in people with~     knee OA. Currently, clinical practice guidelines for the use of orthotics are vague and~     contradictory, and could benefit from more research taking into account foot posture. This~     study aims to compare the use of two orthotics designs in people with knee OA.~   "
101796|NCT02234882|"~     The purpose of this study is to assess the effect of the coadministration of multiple doses~     of BMS-663068 on the systemic exposure of rosuvastatin.~   "
101806|NCT02234739|"~     voriconazole is recommended as first-line therapy for invasive pulmonary aspergillosis,~     however the efficacy and safety of voriconazole for treating invasive pulmonary aspergillosis~     secondary to COPD is not clear. This study aims to investigate the effectiveness and~     tolerability of intravenous voriconazole for treatment of invasive pulmonary aspergillosis in~     Chinese patients with COPD, by monitoring changes in clinical symptoms, eradication of~     aspergillus, improvement of chest imaging as well as record of possible adverse reactions~     following 2-week intravenous instillation of voriconazole.~   "
101959|NCT02232750|"~     The investigators hypothesize that CPD parameters will provide improved prediction of sepsis~     compared to currently employed laboratory parameters. These studies hold the potential to~     shape practitioner guidelines and improve the timeliness and accuracy with which patients~     with sepsis are treated today.~   "
101797|NCT02234869|"~     The primary objective of the study is to evaluate, in participants with RMS, safety and~     tolerability (as defined by the frequency of adverse events [AEs] of flu-like symptoms [FLS;~     chills, pyrexia, myalgia, and asthenia], injection site reactions [ISRs], and injection site~     reaction pain [ISR-P]) over 6 months of treatment (the active comparator period) with BIIB017~     125 μg subcutaneously (SC) every 2 weeks versus standard-of-care SC interferon-beta (IFN-β)~     therapy. Secondary objectives of this study are to assess the following measures during the~     first (6-month) period of the study in participants treated with BIIB017 versus~     standard-of-care SC IFN-β therapy: patient-reported treatment satisfaction using the~     following patient-reported outcome measures (PROMs): Treatment Satisfaction Questionnaire for~     Medication (TSQM-9), Adapted MS Treatment Concerns Questionnaire (MSTCQ), Adapted MSTCQ Side~     Effects Score, Pain using a visual analog scale (VAS) diary and the McGill Pain Questionnaire~     Short Form (SF-MPQ), the treatments' impact on RMS using the following PROMs: Multiple~     Sclerosis Impact Scale (MSIS-29), Modified Fatigue Impact Scale-5 Item (MFIS-5), EuroQol~     Group 5-Dimension 3-Level Version (EQ-5D-3L), Health-Related Productivity Questionnaire~     (HRPQ), Beck Depression Inventory, second edition (BDI-II), participant adherence to study~     treatment, clinical status as measured by the Expanded Disability Status Scale (EDSS) and~     relapse activity, safety and tolerability of study treatment after a change in~     standard-of-care SC IFN-β therapy and the immunogenicity profiles of participants changing~     from standard-of-care SC IFN-β to BIIB017.~   "
101798|NCT02234856|"~     This study aims to test the validity of a new educational tool in the form of a computer~     based video surgical simulator, that may be used to enhance the current teaching method of~     how to perform a hysterectomy.~   "
101799|NCT02234843|"~     The purpose of this study is to evaluate comparative efficacy and safety of rivaroxaban to~     standard of care in children with acute venous thromboembolism.~   "
101800|NCT02234830|"~     Is the ExoSeal VSD non-inferior to Angio-Seal vascular closure device (VSD) in the incidence~     of adverse access site related events at 30 days.~   "
101801|NCT02234804|"~     Prospective, controlled, double randomized, non-blinded, multicenter, investigator initiated,~     academic superiority trial comparing optical coherence tomography (OCT) guided vs.~     angiography guided wire recrossing in jailed side branches (SB) (1. randomization~     1:1)(superiority) and comparing Medtronic Resolute Integrity and Xience Prime for stent strut~     apposition in the SB ostium (2. randomization 1:1) (superiority). Acute primary endpoint and~     30 days clinical follow-up.~      Hypothesis: OCT guided wire recrossing in bifurcation stenting results in less malapposed~     struts in the segment facing the SB ostium.~      Secondary hypothesis: Treatment by Medtronic Resolute Integrity stent results in less~     malapposed struts at the bifurcation segment compared to treatment by the Abbott Xience Prime~     stent.~   "
101802|NCT02234791|"~     X-linked agammaglobulinemia (XLA) is a humoral primary immunodeficiency in which affected~     patients have very low levels of peripheral B cells and a profound deficiency of all~     immunoglobulin isotypes. Mutations in the gene encoding for Bruton's tyrosine kinase (Btk)~     are responsible for most of the gammaglobulinemia.~      We tend to investigate the gene mutation and clinical features of Chinese X-linked~     agammaglobulinemia (XLA) patients, and also examined the relationship between specific Btk~     gene mutations and severity of clinical presentation.~   "
101803|NCT02234778|"~     The purpose of this study is to determine the safety and effectiveness of the Tissue Genesis®~     Icellator Cell Isolation System™ in Critical Limb Ischemia. The Icellator System™ device~     removes certain cells from the adipose (fat) tissue which will be used to treat patients with~     blockages in the arteries of their lower legs that may require a future amputation, which is~     caused by severe peripheral artery disease (PAD). The purpose of this study is to determine~     if treatment with cells that have been removed from the Icellator System™ device will reduce~     the number of major amputations and deaths in a six month time period.~   "
101804|NCT02234765|"~     Obstructive sleep apnea syndrome (OSA) is characterized by the manifestation of excessive~     sleepiness secondary to repeated obstruction of the upper airway during sleep and~     cognitive-behavioral, respiratory, cardiac, metabolic or inflammatory disorders.~     Epidemiological studies in our country have shown that OSA is a highly prevalent disease in~     the general population, affecting 2-4% of the adult population. The most important clinical~     manifestations of OSAS is a deterioration in the quality of life and an increase in~     cardiovascular disease. OSA is also associated with traffic accidents. Therefore, and~     considering the medical complications of OSA, as well as the sociolaboral impact and its~     negative impact on quality of life and survival; is stated that this disease is a public~     health problem that requires the physician to identify patients eligible to treatment.~     Moreover, it has been shown that undiagnosed patients, duplicate the consumption of health~     resources, comparing when the diagnosis and treatment has been established. Finally, we have~     a highly effective treatment using positive pressure in the upper airway (CPAP) that has been~     shown to be effective and cost-effective. The current situation in which all patients~     diagnosed with OSA and receiving different treatments are monitored and controlled by the~     Sleep Units (SU) is an oversized medicine specialist at the expense of primary care (PC). Our~     working hypothesis is: By the coordination of actions at various levels including~     interactive training equipment AP, use the bilateral (SU-AP) of electronic medical records~     and the use of new technologies can be achieved in AP satisfactory management of the~     diagnostic and therapeutic process of patients with suspected OSA. Patients assisted in both~     areas have a level of clinical response, satisfaction, compliance and avoidance of~     complications, similar to that obtained with monitoring by SU. In addition, management by AP~     will be more cost-effective than in the SU.~   "
101805|NCT02234752|"~     Aim: To examine the efficacy of the combination of galantamine and memantine for the~     treatment of cognitive deficits in outpatients with schizophrenia.~      Hypothesis: A combination of galantamine and memantine will improve cognitive impairments in~     patients with schizophrenia.~      This is an open-label study to evaluate whether a six week course of galantamine ER and~     memantine XR is effective in improving the cognitive performance of patients with~     schizophrenia or schizoaffective disorder. The primary outcome measure will be the change in~     level of cognition as measured by the MATRICS Consensus Cognitive Battery (MCCB). The results~     of the MATRICS collaborative project recommended the need for standardized cognitive tests~     that better distinguish the different facets of cognitive dysfunction in schizophrenia. The~     MCCB will assess the following seven domains: attention/vigilance, reasoning and problem~     solving, processing speed, social cognition, verbal learning and memory, visual learning and~     memory, and working memory. The MCCB will be administered at baseline and at the end of the~     study. We will report total score and each domain score in the MCCB at baseline and six~     weeks.~   "
101924|NCT02233205|"~     Ultrasonic sonoporation can increase the release of chemotherapeutics, thus increasing the~     therapeutic effects. The main purpose is to identify the safety of combining ultrasonic~     microbubbles and chemotherapeutics to treat malignant neoplasms of hepatic metastases from~     alimentary system and pancreatic carcinoma.~   "
101807|NCT02234726|"~     The purpose of this study is to evaluate the impact of a community-based early childhood~     development (ECD) program on children's physical and cognitive development. Under the~     program, targeted communities will be assigned a trained Child Development Agent (CDA) who~     will have four main tasks and responsibilities: 1) biweekly screening and management~     (including referral) of acute malnutrition in children; 2) encouragement of caregivers to~     utilize routine care services for children; 3) screening for symptoms of acute diseases~     including malaria, diarrhea, and pneumonia and referral for diagnosis and treatment; and 4)~     organization and mentoring of biweekly caregiver meetings to discuss parenting and promote~     early childhood cognitive stimulation. The investigators will enroll at baseline around 600~     children ages 6 - 12 months and their caregivers, and randomize them at the community-level~     to receive the ECD program or to remain in the control group. The study period will be one~     year. At end line, the investigators will collect important indicators of child physical and~     cognitive development to assess program impact. If the program shows both feasibility and~     impact, there is the potential to integrate program interventions into existing national~     community-based health initiatives.~      Amendment: the study period has been extended for a second year. After a five month gap when~     no intervention was provided, biweekly (i.e., fortnightly) community-based parenting groups~     were restarted in intervention clusters. In the second year of the intervention, CDAs no~     longer visit households.~   "
101808|NCT02234713|"~     Disease modifying therapies (DMT) are widely used for children and adolescents with MS.~     Nonetheless, many pediatric patients continue to relapse and therefore require changes in~     therapy. We designed this research study to learn more about medication use in children and~     adolescents with MS. We are also interested in learning what a behavioral feedback~     intervention can tell us about adherence to medicine. Finally, we hope this research project~     will inform the way we provide clinical care for children and adolescents with MS.~   "
101809|NCT02234700|"~     Comparison between patients with nasolacrimal duct obstruction and healthy patients and the~     influence of their bacterial flora on the corneal epithelium.~   "
101810|NCT02234687|"~     In this study, we propose to employ a randomized, double-blind, placebo-controlled,~     outpatient clinical trial to test the efficacy, safety, and tolerability of a 160 mg and 40~     mg challenge of the mGlu2/3 agonist pomaglumetad methionil relative to placebo in modulating~     fear-potentiated startle response and behavior in adults with post-traumatic stress disorder~     (PTSD) (N=30). Each participant will receive a single dose of the study drug (40 mg vs 160 mg~     vs placebo in a 1:1:1 ratio).~   "
101811|NCT02234674|"~     This study aims at evaluating the efficacy of the Stendo pulsating suit in patients with a~     leg lymphedema hospitalized for intensive Complex Decongestive Physiotherapy (CDP).~      This study is a pilot controlled randomized study with two arms.~   "
101812|NCT02234661|"~     The CAP Family Advancement Study (CAP FAST) is a randomized control trial of CareerAdvance®,~     a dual-generation program providing education, career coaching, and soft-skills training for~     parents while their children attend CAP Tulsa's Head Start programs.~   "
101813|NCT02234648|"~     Given the global health issues associated with poor cardiovascular function, interventions~     that help reduce the severity, with emphasis on prevention would not only have economic~     implications, but would also improve health, wellbeing and quality of life. Research provides~     evidence that consumption of a diet high in plant foods and rich is polyphenols is associated~     with a reduction in the incidence of cardiovascular disease (Hung et al 2004). Tart~     Montmorency cherries have been shown to be high in numerous phytochemicals (Wang et al 1999;~     Seeram et al 2001). Several of these compounds, are known to be vasoactive and improve blood~     vessel function by increasing bioavailability of vasodilators (Mudnic et al 2012), reducing~     vasoconstrictors (Broncel et al 2010), decreasing platelet aggregation (Hubbart et al 2006)~     and increasing blood vessel dilation (Schroeter et al 2006). Impaired function of the lining~     of blood vessels (endothelial dysfunction) has been linked to increased risk of~     cardiovascular disease. However, the bioavailability of all the compounds in Tart Montmorency~     Cherry Juice and their efficacy with respect to vascular function has not been fully~     determined. This study will examine the influence of tart Montmorency cherry juice on~     cardiovascular function, specifically arterial stiffness by pulse wave velocity and blood~     flow in the microcirculation by laser Doppler imaging. This study will also examine digital~     volume pulse and pulse wave analysis. These data will provide information on the ability of~     TMCJ to affect blood flow and vascular function.~   "
101814|NCT02234635|"~     In this study, the investigators examined the subjective visual quality including LogMAR~     uncorrected distance visual acuity (UCDVA), best corrected distance visual acuity~     (BCDVA),uncorrected intermediate visual acuity (UCIVA), distance corrected intermediate~     visual acuity (DCIVA), uncorrected near visual acuity (UCNVA) ,distance corrected near visual~     acuity (DCNVA),using logMAR visual acuity chart,and the objective visual quality including~     Modulation Transfer Function (MTF), Strehl ratio(SR), objective scatter index (OSI), OQAS~     value (OV),and the tear-film quality dynamics including the tear break-up time and the~     tear-film OSI between the eyes with multifocal lens and monofocal lenses by optical quality~     analysis system (OQAS).~   "
101815|NCT02234622|"~     Given the limited effectiveness of current treatments and the burden PTSD places on Veterans~     and clinicians, this research aims to compare the effects of a standardized, traditional,~     holistic yoga intervention (postures, breathing, deep muscle contraction and relaxation~     practices) with a wellness program (wellness topics and physical activity) on PTSD symptoms.~   "
101816|NCT02234609|"~     Atraumatic Restorative Treatment (ART) has become an accepted dental restoration treatment in~     many developing countries. Because, ART is intended to be operated in molars, and about 10%~     of all carious lesion by an age of 18 years appear in anterior teeth in Gambia, it was the~     aim of this study to clinically evaluate a modified ART restoration technique for anterior~     teeth as the traditional treatment approach did not show satisfying clinical results.~   "
101817|NCT02234596|"~     This is a phase II study of Nintedanib in patients with metastatic or recurrent~     esophagogastric cancer. The goal of the study is to evaluate the efficacy of Nintedanib, an~     orally available triple kinase inhibitor targeting the receptors of the vascular endothelial~     growth factor (VEGF), platelet derived growth factor (PDGF), and fibroblast growth factor~     (FGF) receptor pathways.~   "
108311|NCT02149732|"~     To investigate the effect of ocular surface reconstruction and assess the safety in~     cultivated oral mucosal epithelial cell sheet transplantation (COMET) regarding patients with~     cicatricial change of ocular surface.~   "
101818|NCT02234583|"~     This is an open-label study of DS-5565 in subjects who either completed participation in a~     preceding Phase 3 study of DS-5565 in fibromyalgia (FM); i.e. DS5565-A-E309, DS5565-A-E310,~     or DS5565-A-E311 or are de novo subjects. Eligible subjects will be assigned to receive~     open-label DS-5565 for 52 weeks. All subjects will receive DS-5565 15 mg once daily (QD) for~     the first three weeks of the treatment period. After three weeks, subjects may be titrated to~     15 mg twice daily (BID) based on protocol-specified criteria.~   "
101819|NCT02234570|"~     The objectives of the Phase I study are to evaluate the safety and tolerance of increasing~     single oral doses of oxfendazole in healthy volunteers.The secondary objectives assess the~     pharmacokinetic profile of oxfendazole and assess the metabolism of oxfendazole. The~     description of agent used is single oral dose of an aqueous suspension of oxfendazole, a~     benzimidazole carbamate antiparasitic drug. Each new cohort will be dosed only after the two~     week safety data for the preceding group have been reviewed. If a clinically significant AE~     is observed, and if this event is drug-related the safety monitoring committee will be~     convened to determine whether the study should continue.~   "
101820|NCT02234557|"~     Attention Deficit Hyperactivity Disorder (ADHD) has tremendous individual and societal~     impact, and the effectiveness of current standard treatments is limited. We examine a novel~     treatment that could remediate the core features of ADHD and thereby contribute to sustained~     improvements in behavioral control. This approach is motivated by mounting evidence that~     children with ADHD show difficulties with motor control, and that these motor deficits are~     strongly associated with the core behavioral features of ADHD. We employ Tai Chi, targeting~     improvements in well-established behavioral and physiologic measures of motor control, and~     with this, improvements in ADHD symptoms. The proposed study offers immense potential for the~     development of novel therapeutic approaches for ADHD with little risk of adverse reaction.~      The over-arching goal of this proposal is to examine a movement-based mindfulness training as~     a therapeutic intervention for children with ADHD. This approach is motivated by two~     complimentary lines of evidence: 1) Children with ADHD show impairments in motor control that~     parallel (and correlate with) core deficits in behavioral control that define the disorder.~     2) Gains in cognitive and behavioral control have been observed in adults learning Tai Chi,~     dance, or meditation. These lines of evidence provide substantial motivation for our proposed~     investigation of movement-based mindfulness training in children with ADHD. Specifically, we~     propose to evaluate an established Tai Chi-based intervention. We chose this approach for a~     number of reasons: 1) Tai Chi is among the most well-established movement-based interventions~     with documented therapeutic effects, including cognitive effects. 2) While many~     movement-based approaches show evidence of yielding cognitive improvements Tai Chi provides~     excellent opportunities for engagement of 8-12 year old children in the form of the~     collaborative game push hands. 3) Tai Chi instruction consists of gentle movements that can~     be practiced even by those with physical limitations, and is readily available in the United~     States so the protocols developed in this study will be straightforward to deploy at a~     national level.~      Hypothesis: After participating in a Tai Chi program, children with ADHD will show~     improvements in behavioral and physiologic measures of motor control. We further expect~     movement-based training will result in decreases in ADHD symptom severity.~   "
101821|NCT02234544|"~     Double-blind randomized controlled trial to evaluate the serum levels of 25(OH)D after a~     single oral dose of cholecalciferol 50,000 IU plus ezetimibe or placebo.~      Differences between the serum levels of 25(OH)D in response to cholecalciferol plus ezetimibe~     compared to cholecalciferol plus placebo.~   "
101822|NCT02234531|"~     The aim of the project is to assess whether the continuous visualization of on-line teacher~     in virtual reality (VR) is effective for the improvement of upper limb motor function, in~     stroke patients.~   "
101823|NCT02234518|"~     Gastrointestinal discomfort regularly affects >25% of the population worldwide. One of the~     major contributors to GI discomfort is constipation, which has a prevalence of ~15% and~     symptoms of which have a significant negative impact on the sufferer's quality of life. One~     of the hallmarks of chronic constipation is slow progression of contents through the gut~     (i.e. slow gut / colonic transit time), which may be associated with hard stools that are~     difficult to expel.~      Dietary fiber supplements are widely used as a first-line treatment for constipation although~     little Level 1 evidence exists to support its use in adults. The effectiveness of different~     fiber supplements is difficult to compare given wide differences in water-retention~     capabilities and effects on the colonic microbial ecology. Given the promising, yet largely~     unsubstantiated, benefits of fiber supplementation on symptoms of functional constipation,~     the objective of this clinical trial is to evaluate tolerance and effectiveness of four week~     supplementation of a fiber product, in a dose-ranging fashion, on whole gut transit time and~     gastrointestinal symptoms in adults with functional constipation.~   "
101824|NCT02234505|"~     In human gait there is a certain amount of variation between steps; some considered~     physiological and owed to variations in environment or posture, and some severe enough to be~     indicative of gait instabilities that may lead to stumbling and falling. In users of lower~     limb prosthetics, such gait instabilities are of especially great interest.~      The study investigates the correlation between socket alignment quality and gait step-by-step~     variability in users of trans-tibial-prosthetics. It is hypothesized that a clearly defined~     range of step-by-step variability exists, and that therefore step-by-step variability is~     suitable as an outcome variable for the assessment of socket alignment.~      A sample of ten persons with trans-tibial amputation will be recruited for this pilot study.~     Subjects will be asked to walk on different natural surfaces while the socket alignment is~     successively perturbed. Step-by-step variations in horizontal ground reaction forces and~     torsional moments will be measured and statistically compared.~   "
101825|NCT02234492|"~     The purpose of this study is to determine whether the use of rosuvastatin in Human~     Immunodeficiency Virus (HIV) infected individuals lowers inflammation in blood vessels,~     improves blood circulation in the small arteries that provide nutrients to the heart muscle~     and improves neurocognitive function.~   "
101826|NCT02234479|"~     The aim of this study is to compare the effects of Medihoney and Hydrophor on radiation~     dermatitis reactions in a group of women undergoing radiation therapy for breast cancer. It~     is hoped that the outcome of this pilot study will provide evidence supporting the use of~     Medihoney in preventing and treating radiation dermatitis as well as sufficient preliminary~     data to expand this study to larger, federally funded research (R01) looking at the~     beneficial aspects of Medihoney across a spectrum of radiation dermatitis and mucositis in~     several disease settings.~   "
101827|NCT02234466|"~     Randomized controlled trial of pre-operative oral dexamethasone vs placebo for the~     improvement of quality of recovery from surgery. The study population is limited to breast~     surgery patients. The investigators will also look at the effect of our intervention on post~     operative nausea and vomiting.~      Patients will be recruited before the date of their surgery and will complete the Quality of~     Recovery-40 (QOR-40) questionnaire before their surgery and at 24 hours post op. They will~     also complete a Clinically significant nausea and vomiting score upon discharge from the post~     anesthesia recovery room, repeated at 24 hours post op.~   "
108344|NCT02149290|"~     This study will evaluate the accuracy of data on body position, daily activity, heart rate,~     6-minute walk test, and a health survey collected by the wearable cardioverter defibrillator~     (WCD).~   "
101828|NCT02234453|"~     The investigators hypothesise that cancer patients on systemic anticancer therapy can measure~     a home blood count, temperature, record qualitative data and transfer the results~     electronically to the hospital clinical team.~      A low neutrophil blood cell count (neutropenia) can be a dose-limiting toxicity of systemic~     anti-cancer therapy (SACT) and can be life-threatening when complicated by sepsis. Neutrophil~     count is usually obtained by venepuncture by a health-care professional. The Minicare H-2000~     is a new device which facilitates home self-testing of blood count, temperature and symptoms.~     The four components are i) blood count recorder using a capillary sample obtained via~     finger-prick ii) Bluetooth linked thermometer iii) tele-hub collecting patient-reported~     outcomes and iv) secure communication through the 3G network.~      The investigators propose a single-centre, non-randomised feasibility study to test the~     process of patients on chemotherapy using the Minicare H-2000 to deliver self-tested blood~     count readings, temperature and qualitative data electronically to the hospital clinical~     team. The aim is to test training of patients to use a finger-prick method of obtaining blood~     count, patient ability to perform the test, retention of training, the ability of the~     Minicare H-2000 to facilitate the data transfer and to test the secondary care interface.~     This study will provide preliminary data on the potential of Minicare H-2000 to prevent~     wasted hospital journeys when the blood count has not recovered sufficiently for subsequent~     SACT cycles. The investigators intend to obtain informed consent to recruit between 30 to 80~     patients to this study which will be performed in addition to current local standard of care.~      This study enables identification of suboptimal areas of the process prior to investigating~     the application of the minicare H-2000 within oncology to improve the clinical patient~     pathway. The investigators ongoing intentions are to trial the use of the Minicare H-2000 to~     reduce frequency and severity of neutropenic complications, prevent wasted hospital journeys~     and hospital resources, reduce non-elective hospital admissions and personalise delivery of~     SACT.~   "
101829|NCT02234440|"~     In this study, consecutive patients with cryptogenic cirrhosis (NASH-related cirrhosis),~     coming to ILBS (Institute of Liver & Biliary Sciences) OPD (Out patient Department) or~     getting admitted in the ward will be enrolled on fulfillment of inclusion/exclusion criteria~     and consent of the patient. These patients will be randomised to either metformin arm or~     conventional treatment arm. After enrollment these subjects will be monitored every three~     monthly for total of 12 months or till the primary endpoint is achieved. At the end of the~     study, outcome will be measured appropriately.~   "
101830|NCT02234427|"~     This clinical trial will examine with effect of 2-week aspirin therapy on platelet gene~     expression in persons at high-risk of developing heart attacks due to family history of~     early-onset coronary artery disease~   "
101831|NCT02234414|"~     In Switzerland, the prevalence of vertebral fractures in community- dwelling women is unknown~     and the published data from the Swiss hospitals statistics represent only the tip of the~     iceberg. In addition, the percentages of women correctly identified with vertebral fractures~     due to osteoporosis and the treatment rate of these women with a drug proven to reduce the~     risk of further fractures are unknown. Furthermore, it is not known whether the prevalence of~     vertebral fractures differs between urban and rural areas or between mountain areas and plain~     country, e.g. due to possible differences in sun exposure (vitamin D production) and/ or in~     physical activity and/ or dietary habits.~      Clinical signs and symptoms leading to the suspicion of vertebral fracture(s) lack either~     sensitivity (wall-occiput distance) or specificity (rib-pelvis distance). Whether a~     combination of both would improve sensitivity and specificity is unknown.~      The gold standard for the diagnosis of vertebral fracture relies on antero-posterior and~     lateral X-Rays of the thoracic and lumbar spine. Despite standardization of X-Ray readings, a~     retrospective study of hospitalized elderly patients has shown that as many as 50% of the~     radiographic reports failed to note the presence of moderate to severe vertebral fractures.~     In a primary care setting, fewer than 2% of the women received diagnoses of osteoporosis or~     vertebral fracture, although expected prevalence is 20% to 30% and appropriate drug treatment~     was offered to only 36% of the diagnosed patients.~      The recent availability of software for vertebral fracture assessment (VFA) coupled to DXA~     measurements allows for the detection of vertebral deformities, which is critical for~     management of osteoporosis, as the existence of such deformities substantially increases the~     risk of subsequent fracture. Recently published results show that VFA allows the diagnosis of~     a vertebral fracture. The sensitivity of VFA for detection of vertebral fractures compared to~     expert radiologist reading of X-ray is excellent for grade 2 and 3 fractures, ranging between~     90-94%.~   "
101832|NCT02234401|"~     Cystic Fibrosis (CF) is a life limiting illness. Median predicted UK survival is 41.4 years~     (UK CF Registry 2011). The commonest cause of death is respiratory failure.~      Non invasive ventilation (NIV) is a system which delivers a preset pressure to supplement the~     size and depth of each breath. It is introduced in CF to manage established respiratory~     failure. A nose or a mask which covers both the nose and mouth allows flexible ventilation,~     is used just at night, or for part of the day in addition or for 24 hours as clinical status~     indicates. It is introduced within a normal ward environment and then continued longterm at~     home.Once respiratory failure is established longterm noninvasive ventilation is introduced~     throughout 24 hours and multidisciplinary assessment concludes that the timing is appropriate~     for the individual.~      This study aims to evaluate a potential development of current practice: the use of non~     invasive ventilation during hospital admission only to enhance recovery from an acute~     exacerbation which has caused respiratory failure in those individuals where long term non~     invasive ventilation is not yet indicated. A mixed methods design will allow description of~     the experience of noninvasive ventilation during a semistructured interview to add to~     understanding of the results from an experiment designed to measure the differences between~     noninvasive ventilation and standard care.~      Aim: To compare the clinical efficacy with the patient experience of NIV on recovery from an~     acute respiratory exacerbation complicated by respiratory failure in adult Cystic Fibrosis.~   "
101833|NCT02234388|"~     This registry has been established to gain a better understanding of the clinical and~     emotional presentations of patients with undifferentiated connective tissue disease.~   "
101834|NCT02234375|"~     The study will investigate patients with clinical suspicion for pulmonary embolism (PE) who~     have a contraindication to iodine based contrast. These patients normally get investigated~     with studies such as ultrasound and nuclear medicine studies but the fastest and preferred~     investigation is CT with contrast to look for filling defects in the pulmonary arteries. The~     investigators will assess whether gadolinium, which is currently used with MRI can be used~     with CT as an alternative effective contrast in diagnosis or exclusion of PE. A new type of~     CT scanner, a Dual Energy Scanner will be used to improve the visibility of Gadolinium~     contrast on CT.~   "
101835|NCT02234362|"~     The broad goal of this study was to examine the efficacy and tolerability of vortioxetine~     (flexible dose) for the treatment of major depressive disorder (MDD) in symptomatic women~     around the menopausal transition. We hypothesized that an eight-week treatment with~     vortioxetine would promote a significant improvement of depression symptoms and other~     menopause-related physical symptoms.~   "
101858|NCT02234063|"~     In this genomic medicine implementation pilot project, the investigators aim to conduct a~     randomized trial in a network of community health centers and primary care facilities to~     study processes, effects and challenges of incorporating information for apolipoprotein L1~     (APOL1)-attributable genetic risk for end stage kidney disease in patients of African~     ancestry with hypertension .~   "
101859|NCT02234050|"~     The aim of this study is to collect data on activity, toxicity and quality of life of~     trabectedin therapy in patients with recurrent high-grade meningioma.~   "
115190|NCT02059707|"~     The objective is to assess the effectiveness of permanent exclusion of the LAA with the~     LARIAT RS Suture Delivery Device and accessories in AF patients.~   "
101836|NCT02234349|"~     Pancreas Kidney Transplantation (PKT) is the prominent treatment for type 1 diabetic patients~     with chronic kidney disease and improves patients' outcome. However, in spite of an optimized~     systemic insulin substitution, altered glucose metabolism and beta cell function are reported~     in these patients. The mechanisms behind these abnormalities are still unclear.~     Duodena-pancreatic anastomosis is performed in a heterotopic site (ileum) and thus could~     change physical and chemical properties of intestinal secretions, gut flora, as well as~     intestinal permeability. The effect of this procedure on gut derived metabolic factors, the~     enterohepatic cycle of bile acids, incretin secretion and intestinal flora have never been~     studied. This pilot prospective, study is aimed to evaluate the modification of bile acids~     concentrations and composition in PKT subjects, and the impact in glucose and incretin~     metabolism (measured by oral glucose tolerance test) one year after transplantation. The~     results will be compared to those of kidney transplant patients and control subjects.~   "
101837|NCT02234336|"~     Assessment of wall thickness in hypertrophic cardiomyopathy (HCM) is of diagnostic and~     prognostic importance given its known association with sudden cardiac death. However, data~     regarding comparison of imaging modalities for this key measurement is lacking. This study~     seeks to compare assessment of maximum wall thickness between clinically indicated~     echocardiography (with and without contrast) and clinically indicated cardiac magnetic~     resonance imaging.~   "
101838|NCT02234323|"~     The primary objective of the study is to evaluate the safety of rFVIIIFc (BIIB031) in~     previously untreated participants with severe hemophilia A. The secondary objectives are to~     evaluate the efficacy of rFVIIIFc in the prevention and treatment of bleeding episodes in~     previously untreated patients (PUPs), to evaluate rFVIIIFc consumption for the prevention and~     treatment of bleeding episodes in PUPs, and to describe experience with the use of rFVIIIFc~     for immune tolerance induction (ITI) in participants with inhibitors.~   "
101839|NCT02234310|"~     The primary objective of the study is to evaluate the safety of rFIXFc (recombinant~     coagulation factor IX Fc fusion protein, BIIB029) in previously untreated participants with~     severe hemophilia B. Secondary objectives are to evaluate the efficacy of rFIXFc in the~     prevention and treatment of bleeding episodes in previously untreated participants (PUPs),~     and to evaluate rFIXFc consumption for prevention and treatment of bleeding episodes in~     previously untreated participants.~   "
101840|NCT02234297|"~     Many types of cancer are primarily treated with surgery and patient survival is directly~     related to the extent to which the tumor is able to be removed. It is often difficult for~     surgeons to distinguish tumor tissue from normal tissue or to detect tumor cells that have~     spread from the original tumor site, resulting in incomplete removal of the tumor and reduced~     patient survival. In some sites, such as the brain, it is critical to avoid damage to normal~     tissue around the tumor to prevent adverse effects of surgery on function. We hypothesize~     that BLZ-100 will improve surgical outcomes by allowing surgeons to visualize the edges of~     the tumor and small groups of cancer cells that have spread to other sites in real-time as~     operate. This is a safety study to assess the safety of BLZ-100 in patients with gliomas~     undergoing surgery.~   "
101841|NCT02234284|"~     This proposed study will examine whether health coaches can improve the management of COPD in~     a population of vulnerable patients cared for in 'safety-net' clinics. The study is designed~     as a randomized controlled trial for patients with moderate to severe COPD. Patients will be~     randomized into a health coaching group and a usual care group. Those in the health coaching~     group will receive 9 months of active health coaching. Outcome variables will be measured at~     baseline and after 9 months~   "
101842|NCT02234271|"~     The primary objective of the investigators study was to design a comprehensive and medically~     accurate contraception counseling mobile health application and evaluate the effects of this~     contraception counseling application on the contraceptive methods that patients selected and~     their knowledge of that method.~   "
101843|NCT02234258|"~     Schizophrenia and other psychotic disorders are serious and debilitating mental illnesses~     that incur substantial suffering for patients and major challenges to the investigators~     health care and legal systems. The prodrome is the period prior to onset of psychosis when~     functional decline and clinical symptoms gradually emerge. The presence of a clinical~     high-risk (CHR) syndrome in young adults is associated with heightened risk (25-35%) for the~     later development of psychosis, and for those who do not necessarily go on to develop a~     psychotic illness, research has suggested that the majority continue to have fluctuating~     subthreshold symptoms and poor social and role functioning. There are no specific treatments~     to help with these functional difficulties. However, recent findings suggest that in people~     with schizophrenia, Cognitive Behavioral and Social Skills Training (CBSST) leads to~     significantly greater increase in the frequency of social functioning activities compared to~     treatment as usual or goal-focused supportive therapy, and preliminary data suggest CBSST is~     a feasible treatment for CHR. This proposal is a competitive application for a three-site,~     longitudinal study aimed at testing the effectiveness and feasibility as well as mediators~     and mechanisms of action of a manualized CBSST intervention that will target functional~     difficulties associated with clinical risk states for psychosis. The goals are 1) to examine~     whether CBSST compared to a placebo intervention (psychoeducation) matched for group~     involvement and therapist time improves functioning in youth at CHR and 2) to determine~     whether reduction in defeatist beliefs and improvement in social competence mediate change in~     psychosocial functioning in CHR youth in the CBSST. In this single-blind randomized 2-arm~     trial participants will be randomized to one of two treatments: CBSST, an 18-week group~     comprised of three modules; 1) Cognitive Skills; 2) Social Skills; and 3) Problem Solving, or~     a psychoeducation support group that does not teach active cognitive behavioral therapy or~     social skills training. Over a five-year period, the multi-site collaboration will follow~     large CHR sample that will undergo comprehensive assessments of psychosocial and behavioral~     changes, to examine changes in social and role functioning, as well as symptom changes from~     baseline to the end of treatment, and to 6 month follow-up. This approach will demonstrate~     the feasibility of a treatment for which it is easy to train therapists and which can readily~     be disseminated to regular clinical community practice. In addition, it will provide insights~     into likely approaches to halting or mitigating the pathological process and advance the~     investigators understanding of risk prediction; both critical steps in prevention.~   "
101844|NCT02234245|"~     The purpose of this research is to estimate the outcomes in health and cost of the follow-up~     of patients with pacemakers.~      The initial hypothesize of this study is that remote monitoring of pacemaker will show a best~     relation of outcomes in costs and effectiveness than the conventional follow-up in hospital.~   "
101845|NCT02234232|"~     The primary aim of this pilot study is to evaluate the feasibility and safety of four~     different types of intradialytic exercise (exercise performed during dialysis) programs:~     resistance, aerobic, combined resistance and aerobic, and flexibility (attention control).~     The secondary aim of the study is to estimate the effect of aerobic and resistance exercise,~     each compared with the attention control on: health-related quality of life, tests of~     physical performance, strength, and physical activity outside of the dialysis unit. The~     results of this study will be used to inform the planning of a full-scale efficacy study.~   "
101846|NCT02234219|"~     Comparison of Circular(Soave)and Heart-shaped Anastomosis in Hirschsprung's disease.~   "
101847|NCT02234206|"~     This is an Open clinical trial to study the safety and efficacy of Chandrakanthi Choornam in~     40 patients with Oligospermia. Chandrakanthi choornam is a formulation consisting of 25~     ingredients. They are Curculigo orchioides -rhizome, Madhuca longifolia - flower, Cinnamomum~     verum -bark,Cinnamomum tamala-Leaf, Syzygium aromaticum - flower bud,Coscinium~     fenestratum-stem bark,Mesua ferrea-flower, Maerua arenaria-tuber, Adhatoda vasica- seed,~     Moringa oleifera-seed, Lawsonia inermis-seed, Vitis vinifera- fruit, Bombax ceiba- gum,~     Bambusa aurundinaceae-salt,Phoenix dactilifera- fruit,Ilicium verum- flower, Mucuna~     prurita-seed, Cyperus rotundus- rhizome, Glycyrrhiza glabra-root, Tribulus terrestris-fruit,~     Cuminum cyminum-seed,Costus speciosus-root,Myrsitica fragrans-seed, Alternanthera~     sessilis-seed and asphaltum-mineral. Treatment duration is three months.Study is conducted in~     India (Chennai). Primary outcome measure is to see the changes in sperm count, motility and~     morphology. Secondary Outcome measure is to see the impact on the harmone level.~   "
101848|NCT02234193|"~     The investigators are doing this research study to learn about how the skin heals after many~     microscopic skin biopsies are collected.~      Skin-grafting is a life-saving procedure for people with large area skin wounds caused by~     burns or trauma. Conventional autologous (self) skin grafting techniques require the creation~     of large donor site wounds, causing numerous complications including pain, infection,~     blistering, discoloration, and scarring. Based on previous research, many of these adverse~     effects can be improved, or even eliminated, by harvesting skin tissue in very small~     biopsies. These micro-biopsies are less than the size of a sewing pin. Then, they are put~     back together into a skin graft.~      This concept is based on clinical observations from fractional photothermolysis laser~     therapy, an FDA approved laser that has been previously developed by the investigators~     research group for the treatment of scars and ageing skin. With this laser technique,~     thousands to millions of small burns are produced by laser on a patient's skin, and the skin~     responds by healing the damaged areas to create new healthy skin within days and without~     scarring.~      Although the results of laser treatment are well-known, it is not known what happens when we~     harvest the skin using needles instead of using the laser to cut the skin. The investigators~     also would like to understand how the body heals the skin. Understanding how this works helps~     in understanding wound healing, and may lead to future treatments for healing large wounds,~     disfiguring burn scars, and preventing scar formation.~      A tummy tuck (abdominoplasty surgery) is done to remove excessive skin of the belly. This is~     an elective surgery, in other words, it is optional and usually done for cosmetics reasons~     (to improve the appearance).~      The skin of the belly that is removed during an abdominoplasty surgery (tummy tuck) is~     discarded. The skin of the area removed is called pre-abdominoplasty skin. The~     investigators would like to study the effects of the micro-biopsies on pre-abdominoplasty~     skin to exam how the skin heals over time and to study the skin that will be removed during~     the abdominoplasty surgery.~      This is a pilot study. Pilot studies are done on a small group of subjects to learn if a~     larger study would be useful.~      The investigators are asking subjects to take part in this study who are healthy with an~     abdominoplasty surgery (tummy tuck) scheduled at Massachusetts General Hospital (MGH) by a~     plastic surgeon .~      The investigators will enroll about 28 subjects in this research study, all at MGH.~      The Department of Defense is paying for this study to be done.~   "
101849|NCT02234180|"~     This randomized phase II trial studies how well regorafenib works in treating patients with~     cancer of the esophagus or gastroesophageal junction that has spread from where it started to~     nearby tissue or lymph nodes and have completed chemoradiation therapy and surgery.~     Regorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth.~   "
101850|NCT02234167|"~     The purpose of the Swedish Prison Program which started back in 1987 and up until 2009 was~     called The Social Medicine Remand Prison Project is to target injecting drug users (IDU)~     with primary and secondary health interventions with regards to injecting and sexual risk~     behaviours and infectious diseases such as hepatitis C and B, HIV and sexually transmitted~     infections (STI).~      The overall aim is to assess the effect of different prevention efforts on HIV/HCV risk~     behaviour and disease outcome among IDUs over time.~   "
101851|NCT02234154|"~     This Single-Arm Post-Marketing Evaluation will gauge the improvement in function and pain for~     lumbar spinal stenosis and spondylolisthesis patients with the TOPS System.~   "
101852|NCT02234141|"~     This study will compare the efficacy, safety, and tolerability of three doses of selonsertib~     (GS-4997) to placebo in adults with pulmonary arterial hypertension (PAH). The study will~     consist of a 24-week placebo-controlled treatment period and a long-term selonsertib~     treatment period. Participants completing the 24-week placebo-controlled period will be~     eligible to receive active treatment with selonsertib in the long-term treatment period.~   "
101853|NCT02234128|"~     This is a safety study to compare the safety of receiving a lung treated with the Toronto~     EVLP System™ by SPONSOR in SPONSOR's dedicated facility against standard lung~     transplantation.~   "
101854|NCT02234115|"~     The study will evaluate if Leuprolide Mesylate is safe and effective in the treatment of~     subjects with advanced prostate carcinoma, when administered as two injections six months~     apart.~   "
101855|NCT02234102|"~     The study aims to compare the results of pulmonary vein isolation (PVI) with a single~     technology approach in patients suffering from paroxysmal atrial fibrillation (PAF) with~     patients who have persistent AF of less than 3 months. Many studies have shown that~     electrical reconnection of the pulmonary veins following the index procedure can occur in up~     to 40% of targeted veins leading to a recurrence of PAF. Endoscopically guided laser ablation~     utilising the HeartLight system (CardioFocus Inc., USA) has been shown to be safe and~     effective and has also shown promising rates of durable isolation compared to point by point~     radio frequency techniques. However, the impact of employing this technique for patients with~     persistent AF has not yet been reported. The study hypothesis is that there will be no~     statistically significant difference between the results of PVI in the two groups of~     patients.~   "
101856|NCT02234089|"~     The purpose of this study is to detect factors influencing decision making for treatment~     pathways of hormone-naïve prostate cancer patients with and without comorbidities receiving~     medicinal androgen deprivation therapy (Degarelix or LHRH agonists).~   "
101857|NCT02234076|"~     Background: Childhood Sexual Abuse (CSA) and combat related war-trauma are associated with~     posttraumatic stress disorder (PTSD) and depression. PTSD is one of the most prevalent~     Diagnostic and Statistical Manual of Mental Disorders (DSM) axis 1 disorders for which~     psychotherapy is widely practiced. Depression is one of the most common co morbid disorders~     when PTSD is diagnosed. Exposure to the traumatic memories or cues of the traumatic event~     often plays an important role in reducing symptoms of PTSD. Also symptoms of PTSD and~     depression have been related to a reduced specificity in autobiographical memory.~      Objective: This study will examine the efficacy of a Virtual Reality Exposure Therapy (VRET)~     in a CSA and war related trauma sample by comparing it with treatment as usual (TAU). It will~     also attempt to develop protocols to implement this new technology into clinical practice and~     collect data to develop a treatment progress prediction model.~      Study design: A randomized controlled intervention study.~      Study population: 144 individuals with memories of CSA or war related trauma and symptoms of~     PTSD and/or depression.~      Intervention: VRET or TAU.~   "
101860|NCT02234037|"~     STUDY BACKGROUND AND PURPOSE:~      Acute myelogenous leukemia (AML) is a common type of blood cancer in adults, and is more~     common with increasing age. AML is harder to treat in older patients, with typically poor~     responses to standard chemotherapy.~      Patients with AML are typically given intensive induction chemotherapy, but many older~     patients cannot tolerate the side effects of this therapy. Decitabine has been shown to be~     active and better tolerated in frail patients with AML; however, most patients still relapse.~      Recent studies suggest that improving the performance status and fitness of older AML~     patients prior to induction chemotherapy may help to lessen side effects.~      This study will test the combination of decitabine treatment with physical exercise in~     elderly patients with AML who are not candidates for standard induction chemotherapy.~      STUDY DESCRIPTION:~      This is a pilot study to test the combination of decitabine treatment with an 8-week physical~     exercise program in AML patients ≥ 60 years of age who are not candidates for standard~     induction chemotherapy. Patients who are eligible to take part must give their written~     agreement before they can be enrolled.~      This study will enroll 20 patients who are not candidates for standard induction~     chemotherapy. Patients will begin an 8-week program of physical exercise, including 2-3~     sessions per week supervised by a physical therapist. During this 8-week period, patients~     will be given 2 cycles of decitabine therapy (daily infusion for 5 consecutive days of a~     28-day cycle).~      Patients will be followed to assess the safety and tolerability of the program. Patients will~     also give blood samples that will be used to assess their response to treatment. Patients~     will be evaluated for their physical fitness before and after the 8-week exercise program and~     will complete questionnaires to assess their quality of life before and after the program.~   "
101861|NCT02234024|"~     The purpose of this pilot project is to see if a supplemental form of dietary gangliosides~     can serve as a potential treatment for the rare metabolic condition called ganglioside GM3~     synthase deficiency.~   "
101862|NCT02234011|"~     This study is being done to learn whether administration of intranasal (inhaled through the~     nose) ketamine reduces symptoms of obsessive-compulsive disorder (OCD). Ketamine has been~     approved by the U.S. Food and Drug Administration (FDA) as an anesthetic agent (a medicine to~     reduce pain during surgery and other procedures) but ketamine has not been approved by the~     FDA as a treatment for OCD.~      The investigators believe that ketamine may be effective in reducing symptoms of OCD due to~     its ability to decrease the activity of a specific brain chemical called glutamate. Previous~     studies have shown that people with OCD can have abnormal levels of glutamate in their~     brains. This is the first time that intranasal ketamine is being studied in people with OCD.~     However, studies have been done in the past using intravenous (IV; through a needle into a~     vein in your arm) ketamine in people with OCD, and intranasal ketamine has been studied in~     people with other psychiatric conditions.~      This research study will compare ketamine to placebo. The placebo looks exactly like~     ketamine, but contains no ketamine. At some time during the study, the investigators will~     give you ketamine. At another time, the investigators will give you placebo. Placebos are~     used in research studies to see if the results are due to the study drug or due to other~     reasons.~   "
101863|NCT02233998|"~     The reduction of existing plaque and gum inflammation will be evaluated using two marketed~     mouth rinses along with tooth brushing after 21 days of use compared to a placebo mouth~     rinse.~      165 healthy volunteers will be enrolled in this three week study. Volunteers who qualify to~     be in this study will have an equal chance of being assigned to one of the three treatment~     groups. Volunteers will have a total of three visits including 1) Screening/Baseline Day 1 2)~     Day 11 (after 10 days of use) and 3) Day 22 (after 21 days of use). Volunteers will maintain~     a diary at home to record each treatment use and will be asked to come to the clinic without~     brushing or use their product for at least 8 hours, but no more than 18 hours. Examinations~     for oral hard/soft tissue, gingivitis, bleeding and plaque assessments will be completed at~     Screening/Baseline and repeated at Clinic Visit 3, which is Day 22.~   "
101864|NCT02233985|"~     - Determine the efficacy of nebulized salbutamol/hypertonic saline combination in moderate to~     severe bronchiolitis.~   "
101865|NCT02233972|"~     This is an open label, randomized, Parallel Assignment, placebo-controlled study. One of the~     purposes of this study is to investigate the multiple dosing Ginkgolides Meglumine Injection~     to alter the pharmacokinetics of Midazolam, the other is to calculate the pharmacokinetic~     parameters after Single and multiple dosing of Ginkgolides Meglumine Injection.~   "
101866|NCT02233959|"~     Prednisone solution USP (5mg/5mL), is the most commonly prescribed formulation of prednisone~     to pediatric and adult patients. The rationale for this study is that palatability is the~     most important determinant of pediatric patient compliance, and therefore, it is critical~     that the Orbis formulation be perceived as significantly more palatable compared to today's~     commercially available products in order to warrant further development of the TP.~   "
101867|NCT02233946|"~     The purpose of this study is to assess the psychometric properties of a brief screening~     questionnaire for alcohol problems among 9- to 18-year-old patients in pediatricians'~     offices, and to pilot test a personalized, computer-facilitated brief intervention delivered~     on a tablet computer and by the provider based on screening results.~   "
101868|NCT02233933|"~     Randomized trial of Argon Plasma Coagulation compared with Argon Plasma Coagulation and~     Hemospray in the therapy of bleeding from Radiation Proctitis~   "
101869|NCT02233920|"~     Study to obtain further information on the tolerability and efficacy of Ventilat®~     metered-dose inhaler in the treatment of Chronic Obstructive bronchitis under conditions of~     daily practice~   "
101870|NCT02233907|"~     Study to obtain further information on the tolerability and efficacy of Ventilat® metered~     dose inhaler in long-term treatment of Chronic Obstructive Pulmonary Disease under conditions~     of daily practice~   "
101871|NCT02233894|"~     Study to obtain further information on the tolerability and efficacy of Atrovent® inhalets in~     the treatment of Chronic Obstructive Pulmonary Disease under conditions of daily practice~   "
101872|NCT02233881|"~     Study to obtain further information on the tolerability and efficacy of Atrovent® inhalets in~     the treatment of Chronic Obstructive Pulmonary Disease under conditions of daily practice~   "
101908|NCT02233413|"~     The purpose of this research study is to find out if a specialized helmet that provides low~     levels of near infrared light, also known as low-level light therapy (LLLT) has any effect on~     the recovery of people who have recently (within 72h) suffered a moderate traumatic brain~     injury (TBI).~   "
101920|NCT02233257|"~     X-linked adrenoleukodystrophy (ALD) is a genetic disorder affecting the brain and adrenal~     glands. Approximately one third of boys who are at risk will develop cerebral disease. Using~     a specific diet and the compound Lorenzo's oil, it can be shown that very long chain fatty~     acids may be lowered in the blood, but it is not known to what degree that may prevent the~     onset of childhood disease.~      This proposal makes available Lorenzo's oil to individuals with ALD, a life threatening~     disorder for which there are presently no other therapies.~   "
115191|NCT02059694|"~     To evaluate the use of recombinant hyaluronidase (rHuPH20) as an adjunctive for local~     anaesthesia, lidocaine 2% with epinephrine 1:100000, for eyelid surgery.~   "
101873|NCT02233868|"~     Background:~      - Brain inflammation due to high alcohol intake may affect thinking, memory, and~     concentration. Researchers want to measure this using positron emission tomography (PET).~      Objective:~      - To study how excessive alcohol consumption affects brain function.~      Eligibility:~        -  Adults 30-75 years old who are moderate or severe alcohol drinkers.~        -  Healthy volunteers.~      Design:~        -  Participants will be screened with medical history, physical exam, interview, and blood~          and urine tests. Their breath will be tested for alcohol and recent smoking.~        -  Phase 1:~        -  Participants will stay in the hospital 3 days. They will have blood and heart tests and~          daily urine tests.~        -  A small plastic tube will be inserted by needle in each arm. One will go in a vein, the~          other in an artery.~        -  Participants will have 2 PET scans with 2 different radioactive compounds. Participants~          will lie on a bed that slides in and out of the scanner with a cap on their head.~        -  Participants will have magnetic resonance imaging (MRI) scans. Participants will lie in~          the scanner either resting with their eyes open or while performing an attention task.~        -  Participants will have tests of memory, attention, concentration, and thinking. They may~          answer questions, take tests, and perform simple actions.~        -  Phase 2 of the study will only be done if Phase 1 results show brain inflammation.~        -  Phase 2 will repeat Phase 1.~        -  For healthy volunteers, Phase 2 will begin 3 weeks after Phase 1.~        -  Other volunteers must not have alcohol for at least 3 weeks and stay in a hospital up to~          4-6 weeks between Phase 1 and Phase 2. After Phase 2, they will have 5 follow-up calls~          over 3 months.~   "
101874|NCT02233855|"~     Background:~      - Neurocysticercosis (NCC) is caused by tapeworms that infect people. NCC can lead to serious~     brain problems such as seizures, sevre headaches and difficulties with movements or sensation~     in the limbs. Researchers want to learn more about the different ways in which people in the~     United States present with this disease and how they respond to standard and newer~     treatments.~      Objective:~      - To learn about the different forms of NCC that occurs throughout North America and how~     patients with these forms respond to treatment.~      Eligibility:~      - Adults age 18 or older with NCC.~      Design:~        -  Participants will be screened with:~        -  Medical history and physical exam.~        -  A computed tomography (CT) brain scan The participant will lie still on a table that~          slides into a large donut-shaped scanner.~        -  Blood drawn through an arm vein for analysis~        -  A magnetic resonance imaging (MRI) scan of the brain and spine. They will lay flat in a~          long metal cylinder as the machine makes images of the body. During the scan,~          participants will receive a contrast agent through an IV that allows high resolution~          imaging of the brain and spine~        -  Participants will visit the clinic at 0, 1, 2, 3, 6, 12, and 24 months (7 times), and~          depending on the need for monitoring, more times. Participants will receive a schedule~          that will explain the procedures done at each visit.~        -  At these visits, participants may:~        -  Repeat the screening procedures.~        -  Be asked about their NCC symptoms and their physical and mental health.~        -  Have a urine test.~        -  Take a test of their ability to concentrate, their memory and spatial recognition.~        -  Have a lumbar puncture, if indicated by the state and severity of infection. A needle~          will be inserted through the skin and into the space between the bones in the back.~          Cerebrospinal fluid will be removed.~   "
101875|NCT02233842|"~     Background:~      - People who have cancer have more medical problems if they smoke. Some studies show that~     smoking even makes cancer treatment less effective. Researchers want to teach people about~     how tobacco use affects people after a cancer diagnosis. They want to come up with questions~     for people who have cancer and who have survived cancer. The questions will be about using~     cigarettes and other tobacco products and about second-hand smoke.~      The questions will be used to understand how using tobacco affects people with cancer before,~     during, and after treatment. This will help doctors plan how to treat people with cancer and~     create programs to help people quit smoking in the future.~      Objective:~      - To evaluate and refine questions that assess tobacco use.~      Eligibility:~      - Adults age 21 or older who have cancer or are cancer survivors. The cancer can be at any~     site and any stage.~      Design:~        -  This study will take about 1 hour.~        -  Participants will meet one-on-one with an interviewer. They will fill out a~          questionnaire and talk about the questions. Participants will explain how easy or hard~          it was to answer the questions and how they decided on their answers.~        -  All participants will be asked the same or very similar questions. Specific questions~          will be based on the participants own experiences with tobacco products.~        -  There will be no follow-up activities.~   "
101876|NCT02233829|"~     Background:~      - Dopamine is a chemical signal linked to the rewarding effects of drugs. Certain genes make~     these effects sensitive to the time of day they are taken. Cocaine can affect these genes in~     the brain. Researchers want to measure brain dopamine at different times of day.~      Objectives:~      - To look for changes to a person s biological clock in the function of the dopamine reward~     system. To test if cocaine disrupts this.~      Eligibility:~        -  Adults age 21-55 with a cocaine use disorder.~        -  Healthy volunteers age 21-55.~      Design:~        -  Participants will be screened with medical history, physical exam, interview, and blood~          and urine tests. Their breath will be tested for alcohol and recent smoking.~        -  Participants will have 3 overnight clinic visits.~        -  Visit 1: They will have blood and urine collected and a heart test.~        -  A plastic tube (catheter) will be placed into a vein in each arm by needle.~        -  Participants will have a PET scan in a donut-shaped machine. They will lie on a bed that~          slides in and out of it, wearing a cap. A radiotracer (measures dopamine) and a drug~          (blocks dopamine removal) will be injected via catheter. Vital signs will be measured~          and blood will be drawn throughout.~        -  Visit 2: repeats Visit 1, except at night.~        -  Visit 3, participants will have urine collected.~        -  They will have MRI scans in a metal cylinder surrounded by a magnetic field. They will~          lie on a table that slides in and out of it, with a coil over their head.~        -  Participants may answer questions, take computer or paper tests, and perform simple~          actions.~        -  For 1 week, participants will wear a wrist device that measures daily activity.~   "
101877|NCT02233816|"~     A phase II trial multicenter, observer-blind, randomized, dose-ranging, placebo-controlled~     study to evaluate the immunogenicity, safety, and tolerability of a single intramuscular~     injection of plant-derived Seasonal VLP Quadrivalent Influenza Vaccine administered to~     healthy adults 18-49 years of age.~      A total of three hundred subjects will be randomized in four (4) groups of 75 subjects to~     receive one injection of either a low, a medium, or a high dose level of the quadrivalent VLP~     influenza vaccine or the placebo preparation (100 millimolar (mM) phosphate buffer + 150 mM~     sodium chloride (NaCl) + 0.01% Tween 80).~   "
101921|NCT02233244|"~     This drug-drug interaction study will assess the potential of CTX-4430 to induce CYP3A~     activity in healthy subjects.~      The study hypothesis is that midazolam (a sensitive, widely used CYP3A4 substrate) blood~     levels will not change after treatment with CTX-4430.~   "
101878|NCT02233803|"~     This Phase IV study is an a multi-centre, randomised open label, two way cross-over design to~     evaluate the efficacy, safety, and tolerability of NEUMOTEROL 400 in subjects with asthma.~     The study will be used to demonstrate the non-inferiority of Budesonide/Formoterol Fumarate~     combination (BFF) 400/12 micrograms (mcg) single capsule inhaler (NEUMOTEROL 400) compared~     with BFF 320/9 mcg SYMBICORT Forte TURBUHALER® inhaler.~      The population for this study will be adult subjects (>=18 and <=80 years) with a diagnosis~     of asthma who have a pre-bronchodilator forced expiratory volume in one second (FEV1) of 40%~     to 85% of the predicted normal value, and are receiving a stable dose of inhaled~     corticosteroid inhaled corticosteroid (ICS) with or without long-acting beta-adrenergic~     agonist (LABA) prior to screening.~      The study will consist of six phases: Prescreening, Screening/Run-in (4 weeks), Treatment~     Period 1 (4 weeks), Washout (minimum 4 weeks), Treatment Period 2 (4 weeks) and Follow-up (1~     week). The total duration of the study for each subject will be at least 17 weeks. There will~     be up to 6 study visits and a follow-up telephone call.~      Pre-screening Visit will allow subjects who had recent asthma medication changes to be~     stabilized prior to Screening. During the run-in and wash-out periods, all the subjects will~     receive budesonide dry powder inhaler (DPI) 400 mcg twice daily (BID) (NEUMOTEX™ 400) and~     salbutamol 100mcg pressurized metered dose inhaler (pMDI) on demand, as rescue medication.~     The dose of NEUMOTEROL 400 (400/12 mcg) and SYMBICORT Forte (320/9 mcg) will be one~     inhalation BID, and each treatment will be given to all subjects for 4 weeks (with a 4-week~     Washout Period between treatments).~      The study will include 300 subjects for screening so that at least 210 will be randomised and~     a minimum of 168 subjects complete the study/are evaluable. Half the subjects will be on~     Regimen A in Treatment Period 1and will then be crossed over to Regimen B in Treatment Period~     2, and vice versa. Regimen A: BFF (400/12 mcg) by single capsule inhaler. Regimen B: BFF~     (320/9 mcg) TURBUHALER inhaler. The treatment periods will be separated by a washout Period~     of 4 weeks.~      NEUMOTEROL and NEUMOTEX are trademarks of the GSK group of companies SYMBICORT and TURBUHALER~     are trademarks of AstraZeneca~   "
101879|NCT02233790|"~     The patients with acute myocardial infarction (AMI) present high mortality and morbidity~     rate,even treated with stenting in the blocked heart vessels.~      The appearance of no-reflow is common after re-opening of the blocked vessel. The no-reflow~     were commonly attributed to tiny blockage in coronary micro-vasculature by thrombus and spasm~     of the micro-vessel during stenting.~      An agent with more effective anti-clotting and micro-vessel dilation would be helpful to~     solve the issue of no-reflow. Ticagrelor was demonstrated to be a potent platelet inhibitor~     and a potent micro-vessel dilator which can influence metabolism of adenosine, a endogenous~     potent small vessel dilator.~      This study is to test the effectiveness of ticagrelor on improving reperfusion and minimizing~     the myocardial infarct size after PPCI in patients with AMI.~   "
101880|NCT02233777|"~     The present study was conducted to find out whether the bioavailability of 150 mg pregabalin~     capsules produced by Dexa Medica was equivalent to the reference products (Lyrica® capsule~     150 mg, Pfizer Manufacturing Deutschland GmbH, Germany).~   "
101881|NCT02233764|"~     In this study, iron- and zinc-biofortified pearl millet will be fed to young children in~     Mumbai, Maharashtra, India over a period of nine months to measure growth and immune function~     in comparison to children receiving non-biofortified pearl millet.~   "
101882|NCT02233751|"~     Evaluation of pharmacokinetic and safety profile of testosterone after a single dose using~     auto-injector~   "
101883|NCT02233738|"~     Homeless Veterans with substance use disorders (SUDs) are a major group served by VA and are~     heavily represented in VA housing. VA recently adopted a 'Housing First' approach emphasizing~     rapid housing placement to initiate recovery without requiring sobriety and will necessitate~     SUD interventions that are efficient and easily layered onto existing services. The proposed~     study will investigate the effectiveness, implementation process, and cost estimate of Group~     Motivational Interviewing (GMI) for Veterans with SUDs in VA housing (Housing Urban~     Development-VA Support Housing [HUD-VASH] and Grant and per Diem [GPD]). Outcomes will be~     assessed at multiple time points using a multi-modal approach. The ultimate goal of this~     research is to establish the basis of a GMI dissemination and implementation course of action~     for highly vulnerable homeless Veterans in VA housing for achieving their greatest success in~     attaining housing stability.~   "
101884|NCT02233725|"~     Prostate cancer is the most common cancer in men. It is most often detected by an abnormal~     digital rectal exam or an elevated Prostate-Specific Antigen -determine by a blood test. When~     it is suspected that someone may have prostate cancer, a biopsy is ordered. This biopsy is~     performed by the Radiologist with ultrasound guidance through the rectum. In some patients, a~     Magnetic Resonance Imaging (MRI) scan of the prostate may be ordered to further evaluate the~     prostate. In some situations, the MRI and Ultrasound images will be fused (digitally merged)~     together during the ultrasound procedure to help localize the questionable lesions. Recent~     research has used an additional component known as a contrast agent - an intravenously~     injected inert substance - which is identifiable by ultrasound. This inert substance is more~     obvious in areas of increased blood flow, which is a common finding in cancerous lesions. In~     this research project, we would like to determine whether the use of contrast-enhanced~     ultrasound is beneficial in improving accuracy of the biopsies taken and the relative~     correlation to the MRI/ Ultrasound-fused images.~   "
101885|NCT02233712|"~     An open label, dose-finding, schedule-changing, sequential, multiple dose, multi-center study~     in patients with Stage I-III gastric cancer. The first group of patients received a starting~     dose of 250 µg at weeks 0, 1, and 3. Thereafter, allocation to treatment with 100 µg or 500~     µg was based on antibody response and dose tolerability.~   "
101886|NCT02233699|"~     The purpose of this study is to determine the effectiveness of XEN-D0501 over placebo in~     reducing the daytime cough frequency in patients with chronic idiopathic cough.~      The effectiveness of XEN-D0501 over placebo in reducing capsaicin cough responses, objective~     24-hour cough frequency, hourly change in cough frequency, cough severity (via visual~     analogue scale [VAS]), urge to cough (via VAS), global rating of change scale and Leicester~     Cough Questionnaire (LCQ) will be evaluated.~   "
101887|NCT02233686|"~     The purpose of this study is to determine the effectiveness of XEN-D0501 over placebo in~     reducing the daytime cough frequency in patients with chronic obstructive pulmonary disease~     (COPD).~      The effectiveness of XEN-D0501 placebo in reducing capsaicin cough responses, objective~     24-hour cough frequency, hourly change in cough frequency, cough severity (via visual~     analogue scale [VAS]), urge to cough (via VAS), global rating of change scale, Clinical COPD~     Questionnaire (CCQ), Leicester Cough Questionnaire (LCQ), and St George's Respiratory~     Questionnaire (SGRQ-C) will be evaluated.~   "
101919|NCT02233270|"~     When compared to existing analyses: manometry, Smart Pill and lactulose breath testing,~     external Acoustic Esophago-Gastro-Intestinal Surveillance (AEGIS) may identify unique audible~     patterns characteristic of features of gastroinestinal (GI) motility, gastric and small bowel~     contractions and emptying and small intestinal bacterial overgrowth (SIBO). This research~     study is designed to test the capabilities of AbStats/AEGIS to identify and associate~     symptoms and traditional diagnostics with sound readings and correlate this data with~     treatment outcomes and successes in standard of care.~   "
101888|NCT02233673|"~     Excessive weight gain during pregnancy, particularly in overweight and obese women,~     predisposes to adverse perinatal outcomes and has long term effects on maternal and neonatal~     health. With an inverse relationship between socioeconomic status and obesity, significant~     health disparities exist between obese and normal weight women. The Institute of Medicine~     (IOM) recently revised its gestational weight gain recommendations, targeted to pregravid~     body mass index (BMI), to minimize pregnancy complications. However, these recommendations~     are based on cross sectional observational studies and neither the ideal method to achieve~     weight gain goals nor whether perinatal outcome is optimized with active management of weight~     gain is known. The investigators propose to investigate a behavioral incentive-based~     intervention to improve compliance with IOM weight gain recommendations during pregnancy in~     low-income overweight and obese women. The investigators will evaluate if 1) gestational~     weight gain can be reliably targeted to the IOM recommendations and 2) active weight gain~     management during pregnancy improves perinatal outcomes. Two study groups will be compared in~     a prospective randomized trial; 1) those receiving standard obstetrical care and 2) those~     receiving behavioral weight management counseling plus financial incentives for achieving~     weight gain goals. The main outcome measure will be the percentage of women gaining within~     the IOM recommendations based on prepregnancy BMI. Secondary outcomes evaluated will include~     fetal growth and body composition changes, birth weight and the rate of cesarean delivery.~     The investigators hypothesize that 1) the behavioral intervention with incentives will result~     in greater compliance to IOM guidelines for gestational weight gain than standard care and 2)~     targeting weight gain to the IOM guidelines will lead to a reduction in the rates of fetal~     macrosomia and cesarean delivery. Finally, cost effectiveness of treatment conditions will be~     examined. This intervention, if efficacious and cost-effective, has the potential to improve~     compliance with gestational weight gain guidelines, optimize perinatal outcomes, and reduce~     health disparities.~   "
101889|NCT02233660|"~     This randomized clinical trial will investigate changes in hand function, active cervical~     range of motion and pinch grip force after the application of physical therapy in women with~     carpal tunnel syndrome (CTS). The purpose of this study is to compare changes in function,~     cervical range of motion and pinch grip force induced after the application of a physical~     therapy program including manual therapies targeted to those areas related to the median~     nerve or after endoscopic surgery in women with CTS at medium and long-term follow-up. The~     hypothesis is that manual therapy is more effective for increasing cervical range of motion~     and pinch grip force, but similarly effective for improving function, than surgical treatment~     in women with CTS.~   "
101890|NCT02233647|"~     This study will determine the safety and tolerability of phendimetrazine (Bontril®) as a~     pharmacotherapy for cocaine use disorder. A rigorous, inpatient human laboratory study will~     be conducted in which the subjective and physiological effects of cocaine are evaluated~     during maintenance on placebo and phendimetrazine.~   "
101891|NCT02233634|"~     Patients with an impaired blood supply of the heart routinely receive oxygen in order to~     improve or preserve the oxygen supply of the heart muscle in acute cardiac care. In recent~     studies a new innovative MRI-technique that can detect changes in oxygen supply of the heart~     was able to show that the administration of oxygen or fast breathing can decrease the blood~     supply of the arteries supplying the heart muscle with oxygen. Thus, the administration of~     oxygen may paradoxically impair the oxygen supply of the heart muscle. In this study the~     investigators want to investigate, whether the administration of exogenous oxygen via a mask~     alone and in combination with fast breathing leads to a decrease in oxygen supply in regions~     with already impaired blood supply by a narrowing of a coronary artery of the heart.~   "
101892|NCT02233621|"~     Endometriosis is a benign chronic disease responsible for infertility and pelvic pain. One of~     the main problem of endometriosis is the significant delay of diagnosis.This delay has~     significant consequences for patients. Currently the definitive diagnosis of endometriosis~     and the evaluation of its lesional extension require performing laparoscopy and a~     histological analysis of biopsy and pathologic areas. Lesions of endometriosis whose~     development and growth are estrogen-dependent, express estrogen receptor (ER). [18F]FES~     (16α-[18F]Fluoro-17β-estradiol) is an analog of estrogen, used in positron emission~     tomography (PET), and a specific tracer of ER. We propose to evaluate the performance of this~     functional imaging as a diagnostic tool for endometriosis.~      The aim of this multicenter, prospective, open study is to assess sensitivity of PET with~     [18F] -FES for diagnosing endometriosis compared to the gold standard (histological~     confirmation on biopsy or excision of lesions performed during laparoscopy) in women care for~     suspected endometriosis and for whom laparoscopy is already scheduled.~   "
101893|NCT02233608|"~     Radical prostatectomy is a common and effective treatment for prostate cancer but is~     associated with urinary incontinence that can persist for several months after surgery and~     significantly reduce quality of life. Studies have shown that routine performance of pelvic~     floor exercises after radical prostatectomy can aid in the recovery of urinary control;~     however, conventional pelvic floor exercises do not produce consistent results. Research~     indicates that incorporating other deep abdominal muscles can further activate the pelvic~     floor making it stronger than by activating the pelvic floor alone. Specifically, 'Pfilates'~     and 'Hypopressives' are two new techniques that combine traditional pelvic floor exercises~     with activation of supportive muscles. Our proposed study will be the first to test the~     effect of an advanced pelvic floor exercise training program that includes Pfilates and~     Hypopressives to treat urinary incontinence following radical prostatectomy. Our primary aim~     of this study is to assess the feasibility of conducting a full-scale RCT of an advanced~     pelvic floor exercise training program, including standard pelvic floor exercises, Pfilates,~     and Hypopressives techniques on urinary incontinence. Feasibility will be determined by~     measuring recruitment success, retention, outcome capture, and intervention adherence,~     tolerance, and safety. We hypothesize men under going radical prostatectomy for prostate~     cancer in the advance pelvic floor training program will report greater improvement in~     urinary incontinence and health-related quality of life.~   "
101894|NCT02233595|"~     The investigators will be using the combination of FDG-PET and multiparametric MRI in pre-~     and post-adjuvant chemoradiation therapy in order to attempt to predict pathologic response~     on surgical resection.~   "
101895|NCT02233582|"~     Ibuprofen is often taken by travelers to high altitude to treat the symptoms of acute~     mountain sickness such as headache and malaise. However, the blunting of inflammation by~     ibuprofen may slow the process of acclimatization to altitude, which relies on mediators of~     inflammation for adjustments in breathing.~      The study randomizes healthy subjects to receive ibuprofen or placebo and then ascend to~     altitude (12,500 feet). Blood cytokines and non-invasive measurements of blood and tissue~     oxygen levels will be made for 48 hours at altitude. The hypothesis being tested is that~     subjects receiving ibuprofen will have lower blood and tissue oxygen levels after 48 hours at~     altitude than will placebo subjects.~   "
101896|NCT02233569|"~     This is a monocenter randomized controlled trial comparing two systems of mesh and fixation~     device for the laparoscopic ventral and incisional hernia repair with respect to pain. It has~     been designed as a superiority study to proof the concept of previously published~     mathematical model of front abdominal wall.~   "
101897|NCT02233556|"~     Patients with schizophrenia are deeply affected by the positive symptoms, negative symptoms~     and cognitive impairment. A generalized cognitive deficit could be frequently observed and~     traced back to early stage of the disease. Currently medication intervention significantly~     improves positive symptoms through dopamine receptor modification, leaving alone the negative~     symptoms and cognitive impairment. Besides dopamine dysregulation, more and more attention~     had been paid to the association of N-methyl-D-aspartate (NMDA) type glutamate receptor and~     schizophrenia, focusing on the neurobiological and cognitive biomarkers change. Memantine, an~     uncompetitive antagonist of NMDA type glutamate receptor approved as cognitive enhancer for~     Alzheimer's disease, is a potential candidate for preventing cognitive decline of~     schizophrenia. Previous randomized clinical trials failed to demonstrate its efficacy on~     chronic schizophrenic patients and it might be related to the chronic and irreversible~     disease process. There is also study supporting that memantine induces change in mismatch~     negativity (MMN) in frontal cortex of healthy subjects. This study will compare the MMN~     change of healthy subjects and the population of early schizophrenia, who has persistent~     neurobiological, cognitive biomarkers or negative symptoms despite subsided positive~     symptoms. Both male and female aged 20-45 years old outpatients with a length of illness for~     less than 5 years since first diagnosed as schizophrenia, currently receiving treatment by~     atypical antipsychotics in a relatively stable condition will be recruited. Healthy subjects~     will be recruited comparing their age and sex. We plan to recruit 10 subjects for both~     patient and healthy subjects with a total of 20 participants. All participants will receive~     general clinical, cognitive and event-related potential (ERP) evaluation as baseline before~     taking medication. Twenty mg of memantine will be given 4 hours before ERP retest. The~     analyses will be performed based on the change of ERP using paired-t sample test. Baseline~     clinical and cognitive symptoms will be analyzed as possible confounders.~   "
101898|NCT02233543|"~     The purpose of this study was to determine whether a fixed dose combination of indacaterol~     and glycopyrronium (QVA149) has an impact on night-time blood oxygen levels in Chronic~     Obstructive Pulmonary Disease.~   "
101899|NCT02233530|"~     This trials of cognitive stimulation therapy (CST) in Tanzania is part of the larger~     Identification and Intervention for Dementia in Elderly Africans (IDEA) study.~      The overall aim of the IDEA study is to set up and evaluate sustainable programmes to~     facilitate diagnosis of, and therapy for, people with dementia led by local communities in~     sub-Saharan Africa. The investigators seek to improve quality of life for people with~     dementia and their caregivers.~      Within this trial of CST, the investigators hypothesise that CST can significantly improve~     the quality of people with dementia and their carers living in Africa~   "
101900|NCT02233517|"~     Posttraumatic stress disorder (PTSD) robustly predicts anger and aggression, and U.S.~     Iraq/Afghanistan-era combat Veterans report that treatment for anger and aggression is among~     their top priorities. PTSD-related anger and aggression are associated with profound~     functional impairments, yet to date there are no empirically-supported treatments for~     Veterans with PTSD and aggression. Effective group treatment programs could improve~     functioning and facilitate community reintegration for these Veterans. Given that anger~     impedes progress in treatment of PTSD symptoms, group anger treatment could also improve~     Veterans' capacity to benefit from individually-administered empirically-supported therapy~     for PTSD such as prolonged exposure or cognitive processing therapy.~   "
101901|NCT02233504|"~     The purpose of this trial is to examine the hematologic response rate of Exjade® in patients~     with AML and high risk MDS and chronic iron overload from blood transfusions. Deferasirox has~     been developed as an iron-chelating agent, and unlike deferoxamine, a previously developed~     iron chelator, deferasirox has the advantage of oral administration.~   "
101902|NCT02233491|"~     Post-transplantation diabetes mellitus (PTDM) is a common medical complication after kidney~     transplantation, related to both transplant-specific and generic risk factors, and is~     associated with major complications after transplantation. The current PTDM Consensus Report~     recommends lifestyle modification (e.g. weight loss, dietary modification, structured~     exercise program) as the first line therapy of choice. No recommendation is given with~     regards to how such guidance should be delivered. In addition no clinical evidence exists to~     suggest lifestyle modification provides any sustained glycaemic benefits for kidney allograft~     recipients.~      While in the general population the benefits of lifestyle modification have been well~     documented with regards to attenuation of both pre-diabetic and diabetic states in the~     context of randomised controlled trials, no similar level of evidence exists post kidney~     transplantation.~      This prospective randomised controlled trial is designed to compare active versus passive~     lifestyle intervention post kidney transplantation, to determine changes in cardio-metabolic~     risk profile over the course of the intervention.~   "
101903|NCT02233478|"~     This study is comparing the quantity of active metabolites from consuming pomegranate juice~     in three different preparations. People who participate in this study will come in to the~     Center for a screening visit, which includes a blood test and medical history. If you qualify~     based on the screening visit, you will then come in to the Center while fasting in the~     morning on three different days. You will eat a standardized breakfast and drink one of three~     juices, and then remain for metabolic testing at the Center for a period of time after~     eating. You will also be provided a standardized lunch and water during this period. Each of~     those visits will last about 7 hours. During this time, and for the rest of the 24 hours~     following drinking the juice, you will collect all of your urine. Following all three of~     these 7-hour visits, you will return to the Center again the next day for a fasting blood~     draw, drop off your urine sample, and pick up a new container to collect another 24 hour~     urine sample. The following day, you will return to the Center to drop off your second urine~     sample collection.~   "
101904|NCT02233465|"~     Parastomal herniation is difficult to treat. Several different treatment has been tested but~     still none has revealed to be superior. The use of a mesh has been shown to be a promising~     way of treating. In this study the investigators will evaluate safety and hernia recurrence~     rate with a mesh tailored to treat parastomal hernias Parastomal hernia mesh BARD in~     patients with parastomal hernia requiring surgery.~   "
101905|NCT02233452|"~     Methadone and ketamine are effective for neuropathic pain management. However, the benefits~     of the association of both drugs are uncertain. Here, the investigators conducted a~     randomized, double-blind, in parallel, active controlled clinical trial to test the~     hypothesis that methadone combined ketamine (methadone/ketamine) is more effective than~     methadone or ketamine alone in reducing neuropathic pain.~   "
101906|NCT02233439|"~     The purpose of this study is to assess the effectiveness of a commercially available product~     containing a combination of Silybum marianum and Galega officinalis to support continuation~     or augmentation of breast milk production.~   "
101907|NCT02233426|"~     The purpose of this study is to assess the effectivity of using hypertonic nasal solutions~     alone on the symptom scores and nasal eosinophil levels of allergic rhinitis patients,~     retrospectively.~   "
101922|NCT02233231|"~     This is a study describing changes in inflammation of the airways in asthmatics before and~     after smoking cessation and steroid treatment.~   "
101909|NCT02233400|"~     Bariatric surgery is the only proven and effective long term treatment for morbid obesity. In~     an attempt to reduce patients' post-operative hospital stay, lower associated health care~     costs, and improve satisfaction scores, St Luke's University Health Network (SLUHN) recently~     adopted a fast track bariatric surgery (FTBS) protocol. Findings to date show that FTBS is~     safe and effective when performed in a Center of Excellence (COE) such as ours. However,~     post-operative pain control remains a challenging issue, with only intravenous (IV) or PO (by~     mouth) narcotics appropriate for bariatric surgery patients.~      IV acetaminophen, which has been used successfully in Europe, was recently approved by the~     Federal Drug Administration (FDA) for use in the US. However, no data exist regarding the use~     of IV acetaminophen in bariatric surgery patients, nor are there any data assessing its cost~     effectiveness. Therefore, our study will investigate the economic impact of administering IV~     acetaminophen to bariatric surgery patients, as well as its effect on clinical outcomes such~     as patients' post-operative length of stay, self-reported pain, readmissions, emergency room~     (ER) visits and complications.~      The study design will be a randomized, double-blind, parallel-group, controlled trial in a~     single bariatric Center of Excellence (COE) that is part of the St. Luke's University Health~     Network (SLUHN). Patients will consist of up to 200 morbidly obese adult bariatric surgery~     candidates > 18 years of age undergoing either laparoscopic Roux-en-Y Gastric Bypass (LRYGB)~     or laparoscopic Sleeve Gastrectomy (LSG). Group 1 (treatment) will receive IV acetaminophen~     plus IV narcotics for the first 6 hours post-surgery followed by IV/ PO narcotics for the~     remaining 18 hours. Group 2 (control) will receive IV normal saline plus IV narcotics for the~     first 6 hours post-surgery followed by IV/PO narcotics for the remaining 18 hours. Data~     analysis will include quantile regression, mixed randomized-repeated analysis of covariance~     (ANCOVA) and selected univariate comparisons, with p < .05 denoting statistical significance~     for all outcomes.~   "
101910|NCT02233387|"~     The aim of this study is:~        1. to determine if tumor hypoxia can be accurately visualised with [18F]HX4 PET imaging in~          cervix cancer,~        2. to correlate the [18F]HX4 PET images with blood and tissue markers,~        3. to investigate the quality and optimal timing of [18F]HX4 PET images,~        4. to compare [18F]HX4 PET uptake with [18F]FDG PET uptake before and after treatment and~        5. analyze correlation with responses~   "
101911|NCT02233374|"~     The purpose of this study is to investigate if PET/CT and MRI scans performed early in~     treatment and six weeks after treatment can predict the response of rectal cancer following~     chemotherapy and radiotherapy. This will help doctors to better tailor treatments for rectal~     cancer in the future.~   "
101912|NCT02233361|"~     The proportion of elderly people is expected to increase greatly within the next couple of~     decades, resulting in a proportional increase in the need for hearing rehabilitation.~     However, studies suggest that as many as 40% of hearing aids are never or seldom used. Thus,~     a major challenge for audiological rehabilitation is facilitating the use of fitted hearing~     aids.~      This study has four objectives; 1) to evaluate the effect of advanced notice of a follow-up~     appointment on hearing aid use, 2) to implement a specialized counselling program based on~     MI, 3) to identify barriers to hearing aid use, and 4) to objectively assess hearing aid use~     with datalogging technology.~   "
101913|NCT02233348|"~     Autism spectrum disorders (ASD) is a common childhood-onset, multi-factorial, highly~     heritable, clinically and genetically heterogeneous, neurodevelopmental disorder. Due to its~     high prevalence and severe lifelong impairment without effective prevention and treatment,~     there is a dearth of investigating its pathogenesis, longitudinal outcome, and biomarkers~     (endophenotypes). The ultimate goals of this 5-year project are to prospectively investigate~     the outcome and changes of psychosocial and neurocognitive functions of a cohort of probands~     with ASD at adolescence and young adulthood as the primary aim; and to test whether~     structural and functional brain connectivity can be effective endophenotypes of ASD using the~     unaffected sibling and follow-up designs as the secondary aims.~   "
101914|NCT02233335|"~     Cushing syndrome refers the manifestations induced by chronic glucocorticoid excess and may~     arise from various causes. Iatrogenic Cushing syndrome accounts for most patients, when they~     are given exogenous glucocorticoid treatment. In contrast, spontaneous Cushing syndrome~     results from endogenous glucocorticoid over-secretion. Although Cushing disease is rare, it~     is the most common cause of spontaneous Cushing syndrome. The patient with Cushing disease~     has a pituitary corticotroph adenoma, which overproduces adrenocorticotropic hormone (ACTH).~     ACTH then stimulates adrenal gland to over-secret glucocorticoid. Patients with untreated~     Cushing disease were shown to have poor prognosis, estimated a 5-year survival rate of 50%.~     The first line treatment is tumor resection. Other managements include radiotherapy,~     medication and bilateral adrenalectomy. The initial remission rate is high (66-90%). However,~     some patients encounter with disease recurrence during follow-up.~      The aim of this study is to clarify the factors associated with the recurrence after~     treatment. In this study, we will review the patients with Cushing disease thoroughly and~     analyze associated predisposing factors. These risk factors can remind the clinical physician~     to early detect the recurrent disease in these patients, and further prevent morbidity and~     mortality in their later lives.~   "
101915|NCT02233322|"~     The purpose of the study is to gain a better understanding of the effect of iron on~     fibroblast growth factor 23 (FGF23) in the inherited disorder, autosomal dominant~     hypophosphatemic rickets (ADHR). ADHR is an inherited disorder in which the body makes too~     much FGF 23 and causes low blood phosphorus levels and bone problems such as rickets (bowed~     legs in children) or bone pain and weakness in adults. This study is to test whether or not~     giving iron helps correct the high FGF23 and there by correcting the phosphate problem.~   "
101916|NCT02233309|"~     This study is a prospective study of epidural pressure changes when local anesthetic is~     injected from the caudal route. All patients will receive the same weight based volume dose~     of local anesthetic after induction of general anesthesia, and a CVP transducer will be~     attached to the standard caudal needle for measurement of pressure: under the skin, after~     entering the epidural space, and every 15 seconds for 3 minutes after completion of injection~     with the needle in situ. The placement of the caudal epidural will follow current standard of~     care and administration, the only variation will be the addition of a pressure transducer to~     the stopcock where the local anesthetic syringe is attached that will allow for pressure~     monitoring.~   "
101917|NCT02233296|"~     This study will evaluate the effect of food on the pharmacokinetics (PK) of a single dose of~     lasmiditan in healthy participants.~   "
101918|NCT02233283|"~     Undernutrition has a known and well recognized negative impact on reproductive hormones, and~     ultimately fertility. In contrast, much less is known regarding the potential effects of~     overnutrition on the same hormones. Epidemiological data suggest that overnutrition might~     have a deleterious impact as well on the fertile potential of affected women, but very little~     is known about the mechanisms implicated. Such knowledge may be of importance, given the~     increasing prevalence of overweight and obesity worldwide.~   "
101923|NCT02233218|"~     To investigate the pharmacokinetic Drug-drug interaction~   "
101925|NCT02233192|"~     The purpose of this study is to observe patient response to current clinical practice~     utilizing TRUVADA (emtricitabine and tenofovir disoproxil fumarate) for Pre-Exposure~     Prophylaxis (PrEP) amongst HIV serodiscordant couples desiring to conceive across four U.S.~     cities that are currently offering this method as standard of care. This study is an~     observational cohort study, which will test the feasibility and acceptability of PrEP for~     conception, while examining the challenges and generalizability of this current medical~     practice. The CDC recently released formal clinical practice guidelines for the use of PrEP~     in the United States. For high-risk serodiscordant heterosexual couples using PrEP during~     conception, the guidelines state, PrEP use periconception and during pregnancy by the~     uninfected partner may offer an additional tool to reduce the risk of sexual HIV acquisition.~     Both the FDA labeling information and the perinatal antiretroviral treatment guidelines~     permit this use (CDC 2014).~   "
101926|NCT02233179|"~     The aim of the study was to explore the association between activities of daily living (~     measured using a body-worn sensor) on wound healing in diabetic patients. Since this was an~     exploratory study, there was no study hypothesis.~   "
101927|NCT02233166|"~     In children with OSA (Obstructive sleep apnea) adenotonsillectomy is regarded as the first~     choice of treatment. Studies in recent years have shown that the procedure does not always~     have the expected effect. Children with OSA are at greater risk for complications from the~     procedure.~      There is disagreement regarding the need for sleep studies in children prior to surgery in~     order to verify an OSA diagnosis. Today less than 10% of these children have polysomnography~     (PSG).~      The main purpose of this study is to describe the prevalence of OSA among children referred~     for adenotonsillectomy.~      The investigators will also examine these children prior to and six months after surgery to~     assess their sleep pattern and quality of life.~      The project outcome aims to improve the precision and quality of diagnosis and the short and~     long term effects of treatment of children with OSA.~   "
101928|NCT02233153|"~     The aim of this study is to examine the impact implementing an elder-friendly surgical unit~     has on post-operative complications, mortality and quality of life for patients ≥ 65 years~     old who have undergone emergency surgical care.~   "
101929|NCT02233140|"~     Diabetic foot complications are a common and costly problem. Excessive plantar pressures due~     to foot deformities and/or limited ankle dorsiflexion, especially in the presence of~     peripheral neuropathy, can predispose subjects with diabetes for diabetic foot ulcers.~     Achilles tendon lengthening surgery has shown to delay or prevent recurrence of diabetic foot~     ulcers.~      Studies have shown that Shockwave Therapy (EPAT - Extracorporeal Pulse Activation Technology)~     was effective in treating subjects with chronic heel pain and Achilles tendonitis with no~     serious side effects. EPAT, therefore, may allow diabetic patients with ankle equinus to~     perform more effective stretching exercises and may prevent recurrence of diabetic foot~     ulcers.~      The purposed of this RCT is to compare effectiveness of manual manipulation with EPAT versus~     manual manipulation alone on ankle dorsiflexion and dynamic plantar pressure in at-risk~     subjects with a history of diabetic foot ulcer.~   "
101930|NCT02233127|"~     In 2010, 7.6 million children under the age of five died worldwide and yet the causes of only~     2.7% (0.205 million) of these deaths were medically certified. A thorough understanding of~     the causes of child mortality is necessary to guide research efforts aimed at tackling this~     important global health problem. Prospective birth cohort studies present an opportunity to~     examine the relationships between early-life exposures and multiple health and non-health~     related outcomes including death, illness, and socioeconomic factors. In this study, we will~     provide insight into the underlying causes of child mortality by collecting high-quality data~     on early-life exposures and health and non-health related outcomes in the first year of life.~   "
101931|NCT02233114|"~     Is Yogic Exercises (12 weeks) increasing respiratory function, functional capacity and~     quality of life in patients with obstructive lung diseases. With follow up after 6 months.~   "
101932|NCT02233101|"~     Purpose: Examine oral and intravenous Tranexamic Acid (TXA) to determine whether or not the~     different routes of drug administration are equivalent in terms of post-operative reduction~     in hemoglobin, number of transfusions, and post-operative blood loss following TJA surgery.~      Hypothesis: Oral and intravenous TXA are equivalent routes of drug administration.~   "
101933|NCT02233088|"~     Approximately 24% of the US adult population meet criteria for metabolic syndrome (MetS),~     diagnosed by a combination of abdominal obesity, elevated blood pressure, high triglyceride~     and low HDL-cholesterol level, and pre-diabetes. MetS quintuples the risk of diabetes, and~     doubles the risk of cardiovascular disease (CVD), particularly heart failure. Lifestyle~     modification is the initial step of treatment, but few studies have demonstrated early and~     sustained efficacy in remission of MetS. Our preliminary studies of a lifestyle change~     program for patients with MetS included a 1-year of development of an intervention by an~     interdisciplinary team of experts in medicine and the behavioral sciences. The investigators~     then tested the efficacy of the intervention in a treatment-only, proof-of-concept study. The~     investigators achieved our goal of 50% MetS remission after 2 years, in a sample of 26~     patients. This study is the second step of a research program testing an innovative~     bio-behavioral intervention aimed at remitting MetS through lifestyle intervention, by~     focusing on eating patterns, daily activity, and stress management. The overarching objective~     of this research program is to determine the efficacy of the ELM lifestyle intervention to~     achieve remission of MetS. This purpose of the current study is to prepare for a large,~     randomized, clinical trial by conducting a smaller clinical trial that examines the~     acceptability of the ELM intervention (ELM Group) as compared to two other intervention arms~     (ELM Classes, ELM Individual).~   "
101955|NCT02232802|"~     This will be an open-label, randomised, single-dose, 2-way crossover study to determine the~     comparative bioavailability of enoxaparin sodium from the Chemi Enoxaparin s.c. (80 mg/0.8mL)~     with that from the reference IMP, Clexane® s.c. (80 mg/0.8mL), following single dose~     administration in healthy male and female subjects.~   "
101956|NCT02232789|"~     The purposes of this study are 1) to evaluate the abuse liability and human pharmacology of~     mephedrone after oral administration and 2) to compare the pharmacological effects of~     mephedrone with those obtained after administration of oral 3,4-methylenedioxymethamphetamine~     (MDMA, ecstasy).~   "
101957|NCT02232776|"~     The investigators hypothesize that using Losartan would help decrease proteinuria in~     controlling proteinuria in children with immunoglobulin A nephropathy.~   "
101934|NCT02233075|"~     REP 2139-Ca is nucleic acid polymer. Nucleic acid polymers have been previously shown to~     clear serum hepatitis B virus surface antigen (HBsAg) both preclinically (in duck HBV~     infected ducks) and in human patients and to act synergistically with immunotherapeutic~     agents such as pegylated interferon-alpha 2a or thymosin alpha-1 to restore host~     immunological control of HBV infection.~      HBsAg is an essential component of the hepatitis D virus (HDV), therefore the direct action~     of REP 2139-Ca in removing serum HBsAg and its synergistic effect with pegylated~     interferon-alpha 2a is expected to have a significant antiviral effect against HDV infection.~      This study will examine the safety and efficacy of REP 2139-Ca therapy when used in~     combination with pegylated interferon alpha-2a in patients with HBV / HDV co-infection.~      The primary hypothesis to be tested is that this combined dosing regimen is safe and well~     tolerated in patients with HBV / HDV co-infection which will be assessed by examining the~     number of patients with adverse events (including reported symptoms and laboratory~     abnormalities).~      The secondary hypothesis to be tested is that this combined dosing regimen will have an~     antiviral effect against HBV / HDV co-infection in these patients which will be assessed by~     examining the following outcomes:~        1. The number of patients with reductions in serum HBsAg.~        2. The number of patients with reductions in serum HDAg and HDV RNA~        3. The number of patients that experience a sustained antiviral response after treatment is~          stopped (reductions in serum HBV DNA and HDV RNA).~      The secondary hypothesis to be tested is that this combination approach can have an effective~   "
101935|NCT02233062|"~     The purpose of this study is to investigate the impact of enteral nutrition therapy on sperm~     quality of patients with crohn's disease.~   "
101936|NCT02233049|"~     Diffuse Intrinsic Pontine Gliomas (DIPG) appear almost exclusively in children and~     adolescents, representing 15 to 20% of posterior fossa tumours. Even if it is one of the most~     common malignant brain tumours, there are only 30 to 40 new cases per year in France. Their~     clinical presentation is stereotyped with a short clinical history and a unique MRI~     appearance that was usually considered as sufficient to establish the diagnosis. The~     prognosis of DIPG is always unfavourable; median overall survival is 9 to 10 months in~     general and most patients will die within two years after diagnosis (Kaplan 1996,Hargrave~     2006). Malignant gliomas infiltrating the brainstem represent the greatest challenge of~     paediatric oncology; despite numerous collaborative studies performed, patients' survival has~     not significantly increased in thirty years (Hargrave 2009). There is no validated prognostic~     factor. There is currently no validated treatment except radiotherapy.~      Several targeted agents have been tested in DIPG (Pollack 2007 Haas-Kogan 2008, Geoerger,~     2011), without knowing whether the target was present in the tumour. A critical review of the~     paradigms of these trials tells us that there are long term survivors in these studies that~     is to say patients who may have benefited from the tested therapy, but they are few. So far,~     the new therapies that have been tried were evaluated one after the other in search of a~     treatment that would be effective for all patients, measuring the treatment effect on median~     survival. They were all rejected as ineffective. However the investigators can challenge the~     endpoint to evaluate efficacy in these trials as the existence of long term survivors (> 18~     months, for example) and their number should not been ignored, especially if targeted~     therapies are considered. The investigators propose a paradigm shift in the choice of~     treatment; the issue raised would be to give to each patient the treatment associated with~     the highest likelihood of efficacy based on the specific biological tumour profile.~      The development of targeted therapies for malignant gliomas infiltrating the brainstem has~     been hampered by the absence of biological data. It is therefore crucial to better understand~     the biology of these tumours. Despite the safety of the biopsy in brainstem tumours, most~     teams of paediatric neurosurgery limit the use of stereotactic biopsy only for clinically or~     radiologically unusual forms. Until recently, there has been no systematic genetic study at~     diagnosis to date and the few available data were confounded by the inclusion of autopsies or~     clinically and radiologically unusual cases (Louis, 1993; Gilbertson 2003; Okada, 2008;~     Zarghooni 2010; Broniscer, 2010; Wu, 2012 and Schwartzentruber, 2012).~      French teams gathered in the French Society of Paediatric Oncology and the European~     consortium Innovative Therapies in Children with Cancer (ITCC) decided a few years ago to~     perform biopsies of these tumours for diagnostic confirmation and to ensure the presence of~     certain therapeutic targets prior to a possible inclusion in a trial evaluating a targeted~     therapy (Geoerger, 2009; Geoerger, 2010). Part of this experiment was reported by the team of~     the Necker Hospital in Paris, confirming the low rate of complications of stereotactic biopsy~     procedure (Roujeau, 2007). The biopsy specimen analysis allowed practicing~     immunohistochemical, genomic (CGHarray), gene expression (transcriptome) and direct~     sequencing of candidate genes studies.~      In this study, the majority of patients will receive a treatment assumed to specifically~     target a biological abnormality identified on the biopsy. More importantly, patients will not~     receive a drug for which the identified target is absent.~      In this first step of the protocol, the patients will thus be allocated to one of the three~     treatment groups as follows:~        -  If the tumor overexpresses EGFR without PTEN loss of expression, patients may receive~          erlotinib or dasatinib allocated by randomization (R1 randomisation).~        -  If the tumor shows loss of PTEN expression without EGFR overexpression, patients may~          receive everolimus or dasatinib allocated by randomisation (R2 randomisation).~        -  If the tumor shows both EGFR overexpression and loss of PTEN expression, patients may~          receive erlotinib, everolimus or dasatinib by randomisation (R3 randomisation).~        -  If the tumor shows neither EGFR overexpression nor loss of PTEN expression (a very rare~          situation in our experience), patients will receive dasatinib (no randomisation).~        -  If the biopsy assessment is not contributive, the treatment will be allocated by~          randomisation between erlotinib, everolimus and dasatinib (R3 randomisation).~   "
101937|NCT02233036|"~     Background:~      People who get chronic illnesses as children are living longer. When they turn 18, they~     switch from pediatric care to adult care. This can be a difficult change. Chronic~     Granulomatous Disease (CGD) is an inherited disease. It causes long-term, repeated~     infections. People with CGD are usually diagnosed when they are very young children.~     Researchers want to find out more about how young people with CGD handle the change to adult~     care. What they learn may make this easier for people with CGD in the future.~      Objective:~      - To identify what helped or hurt young adults with CGD as they went from pediatric to adult~     care.~      Eligibility:~      - Adults with CGD who were 18 24 years old between January 2011 and February 2014.~      Design:~        -  Participants will already be enrolled in NIH studies.~        -  Eligible people will get materials in the mail. They will get a letter with study~          information, an interview questionnaire, and an information sheet.~        -  Researchers will call participants 1 week after the packets are sent. They will talk~          about the study and find out if the person wants to join.~        -  An interview will be completed immediately or scheduled for the future. The interview~          will take about 45 minutes. The researcher will ask the participant about their disease.~          They will also ask about travel to NIH, being an outpatient or inpatient there, and~          legal documents.~        -  Researchers may contact the subjects again by phone if they need more information at any~          point during the study.~   "
101938|NCT02233023|"~     Study to assess and compare the safety of long term oral treatment for Parkinson's Disease~     with pramipexole versus bromocriptine or other dopamine agonists, by measuring~     cross-sectional the incidence of ophthalmologic disturbances, especially signs of retinal~     degeneration, in a matched pair design~   "
101939|NCT02233010|"~     Although post-op renal function decrease is determined by serum creatinine, serum creatinine~     has disadvantages that it increases a long time after renal function decrease and it has~     various increasing time based on the level of renal function. Neutrophil~     Gelatinase-associated Lipocalin (NGAL's) usefulness as an evidence for acute kidney damage~     occurring from post-op cardiac surgery, being critical patients and contrast medium use is~     already proven.~      But NGAL's usefulness for renal function after non-cardiac surgery is not proven and~     especially, NGAL's usefulness for renal injury after non-cardiac surgery in chronic renal~     disease patients is not proven.Therefore, the investigators will study about renal function~     decrease after non-cardiac surgery with NGAL and serum creatinine.~   "
101940|NCT02232997|"~     No well-defined protocols exist to guide fluid administration for prevention of contrast~     induced nephropathy in high risk patients. The investigators will compare long term hydration~     at routine speed(12h before and after procedure at 1ml/kg/h) with short term hydration at~     high speed(1h before and 4h after procedure at 3ml/kg/h) to verify our hypothesis that the~     short term hydration may not be inferior to the long one.~   "
101941|NCT02232984|"~     The purpose of the study is to evaluate different ways to program around extracardiac~     stimulation.~   "
101942|NCT02232971|"~     Background: Patients with type 1 diabetes (T1D) need a lifelong supply of external insulin~     and are advised to aim for near-normalization of blood glucose levels through intensive~     insulin therapy. We propose a new approach for achieving treatment goals in T1D: the combined~     use of insulin and glucagon, i.e. dual-hormone treatment.Only recently the prospect of~     treating patients with soluble glucagon has arisen and thus studies of low dose glucagon~     treatment of mild hypoglycemia are needed to determine whether there is clinical rationale~     for dual-hormone treatment of T1D.~      Aim: The purpose of this clinical study is to investigate the glycemic response to~     subcutaneous glucagon administration during mild hypoglycemia in T1D patients treated with~     insulin pump. Different glucagon doses are applied to determine the most appropriate dose for~     future dual-hormone treatment of T1D.~      Methods: A clinical, randomized, single blinded, crossover study will be conducted. Eight T1D~     patients treated with insulin pump are studied on four days. All patients are in good~     metabolic control (HbA1c < 7.5%), C-peptide negative and with hypoglycemia awareness. On each~     study day, hypoglycemia is induced with subcutaneously insulin and afterward treated with a~     single subcutaneous dose of glucagon. The study procedures are identical on all days except~     from the administered dose of glucagon (day 1: placebo, day 2: 100 ug, day 3: 200 ug, day 4:~     300 ug). All patients are blinded for the glucagon dose and carry out the four days in random~     order.~      Endpoints: The present study focuses primarily on the dose related plasma glucose response of~     glucagon; secondary on the duration of the hyperglycemic effect of glucagon and tertiary the~     glucagon effect on catecholamine, cortisol, growth hormone, free fatty acids and~     triglycerides.~      The study will be conducted from august 2014.~   "
101943|NCT02232958|"~     The purpose of this study is to extend our previous work, in which we demonstrated an~     increase in the internal and cross network connectivity of resting state neural networks in~     patients with cerebral small vessel disease by treatment with hyperbaric oxygen, to at least~     20 more individuals.~   "
101944|NCT02232945|"~     This study aimed to evaluate the efficacy and safety of the nature herbal medicine Banlangen~     granules in patients infected with seasonal influenza A (H1N1,H3N2) and influenza B virus.~   "
101958|NCT02232763|"~     The investigators hypothesize that using Losartan would help decrease proteinuria in~     pediatric chronic kidney disease with tubular proteinuria.~   "
101945|NCT02232932|"~     A prospective, open-label, randomised, multicentre, comparative study in two parallel groups~     comparing an interventional group with liver transplantation preceded by neoadjuvant~     radio-chemotherapy and a control group receiving conventional liver and bile duct resection.~      The primary endpoint will be overall survival at 5 years in the intent-to-treat population.~     The secondary endpoint will be recurrence-free survival at 3 years evaluated by CT-scan and~     tumoral markers (Carcinoembryonic antigen (CAE) and cancer antigen (CA19.9)) in the~     intent-to-treat population.~      The number of subjects necessary is 54 patients (27 x 2): this population will enable the~     demonstration of a significant difference is 5-year survival rates between the transplanted~     group and the resected group with a power of 80% and a first-species risk of 5%, under the~     hypothesis that these survival rates are 70% in the transplanted group and 30% in the~     resected group.~   "
101946|NCT02232919|"~     The burden of morbid obesity to the circulatory, endocrine, and locomotor systems, as well as~     the psychological effects and related health-care costs, are well established in the medical~     literature. Lifestyle and dietary patterns remain critical factors modulating long-term~     weight control of morbidly obese individuals (bodymass index ≥ 40). Various dietary,~     pharmacological, and behavioral interventions have largely failed as therapies, often~     necessitating surgery as the last treatment option. Long term results of bariatric surgery~     suggest that sustained and substantial weight loss can decrease morbidity related to obesity~     secondary complications such as diabetes type 2 and cancers, enhancing the role of surgery~     for morbidly obese subjects. However the adverse effects of bariatric surgery are~     considerable and impact on quality of life. Its long-term failure rates and complications~     call for novel and effective long-term therapies, such as neurosurgical interventions.~      The investigators now propose to enhance our targeting capabilities in a feasibility study of~     low frequency electrical stimulation using VMH-DBS (ventromedial hypothalamic) in six~     morbidly obese patients. After successful targeting, DBS stimulation parameters will be~     systematically evaluated and individually optimized at three-month intervals over a one-year~     stimulation period. Detailed recording of side effects, weight changes, food intake patterns,~     metabolic changes, and behavioral evaluations will be obtained throughout the study.~   "
101947|NCT02232906|"~     Investigation whether a switch from oral iron to intravenous ferric carboxymaltose can reduce~     dose requirements of erythropoiesis-stimulating agents (ESA) and improve Hb levels and iron~     status in adult patients with non-dialysis-dependent CKD who were on a stable ESA/oral iron~     schedule for 6 months prior to enrolment.~   "
101948|NCT02232893|"~     TU-100 is a gastrointestinal drug produced from the three botanical raw materials, Asian~     ginseng, Zanthoxylum fruit (Japanese pepper), and ginger, based on proprietary aqueous~     decoction and granulation technology. The aim of this study is to assess the effect of TU-100~     on abdominal discomfort during the 4 week postoperative period after straight, hand-assisted,~     or robot-assisted laparoscopic colectomy. Optimal efficacy parameters for subsequent outcome~     studies also will be explored.~   "
101949|NCT02232880|"~     The purpose of this study is to test whether abatacept, a drug approved by the Food and Drug~     Administration to treat rheumatoid arthritis, may help blood pressure medications to work~     better. This will be studied in people with high blood pressure that is not well controlled~     on three or more blood pressure medications, the condition also known as resistant~     hypertension. We expect to show that adding abatacept therapy to standardized treatment of~     resistant hypertension will result in a greater decrease in blood pressure at 24 weeks~     compared to treatment with placebo and conventional blood pressure treatment.~   "
101950|NCT02232867|"~     It has been found that arm and leg cycling is similar to walking in terms of the muscle~     activation patterns and joint ranges of motion. In addition, arm and leg cycling and walking~     activate similar neural pathways. Another advantage of arm and leg cycling is that it~     involves coordination of all four limbs in a rhythmic movement. This may be particularly~     beneficial given previous findings that arm movement contributes to the activation of leg~     muscles during walking in humans. This is achieved with interconnected neural pathways that~     link the arms to the legs. These neural interlimb connections remain intact in stroke~     victims, such that maximizing the contribution of the arms to the legs may increase~     coordination for walking. Thus, the objectives of this research are to determine if arm and~     leg cycling can be used to increase the strength of interlimb connections and if this helps~     to improve walking ability in a post-stroke population. It is hypothesized that arm and leg~     cycling will transfer to improvements in walking in a post stroke population.~   "
101951|NCT02232854|"~     According to the literature the management of depressive disorders at primary care level is~     not always consistent with guidelines. The main objective of this study is to test whether a~     Comprehensive Technology-Assisted Training and Supervision Program will improve depression~     management in Primary Health Care clinics in Santiago, Chile.~   "
101952|NCT02232841|"~     The goal of this study is to evaluate the sensitivity and specificity of Electrical Impedance~     Tomography (EIT) as a bedside diagnostic tool for lung pathologies in patients who are~     mechanically ventilated. In electrical impedance tomography low amplitude, low frequency~     current is applied on electrodes, and the resulting voltage is measured and used to computed~     the electrical properties of the interior of the chest as they change in time. The computed~     properties are used to form an image, which can then be used for monitoring and diagnosis.~   "
101953|NCT02232828|"~     Background: For treating deep caries lesions, selective or stepwise, i. e. one- and two-step~     incomplete excavation seems advantageous compared with complete caries removal. However,~     current evidence regarding the success, as defined by not requiring any re-treatments, or~     survival of teeth after different excavations is insufficient for definitive recommendation,~     especially when treating deciduous teeth. Moreover, restoration integrity has not been~     comparatively analyzed longitudinally, and neither patients', dentists' or parents'~     preferences nor the clinical long-term costs emanating from both initial and re-treatments~     have been reported yet.~      Our primary hypothesis is that success rates differ significantly between selectively and~     stepwise excavated teeth. Secondary hypotheses are that restoration integrity is assumed to~     significantly differ between selectively and stepwise excavated teeth.~   "
101954|NCT02232815|"~     This study will examine outcomes for patients treated by planned culotte stenting and compare~     outcomes with 2 different stent platforms, the next generation Synergy II and the Xience~     Xpedition DES platforms.~   "
101960|NCT02232737|"~     This study will examine extended exposure to cigarettes varying in nicotine content among~     people with affective disorders. People with affective disorders are at an increased risk for~     smoking, nicotine dependence, and using high nicotine yield cigarettes and are also at~     significantly increased risk for smoking-related adverse health consequences. Studies testing~     an innovative regulatory strategy of reducing the nicotine content of cigarettes to a~     non-addictive level have shown promising beneficial effects (decreased smoking rate, reduced~     toxicant exposure, and increased cessation) in the general population of smokers. However,~     these studies have uniformly excluded vulnerable populations like people with current~     affective disorders, who may respond differently considering their greater vulnerability to~     smoking and nicotine dependence. Thus, little is known scientifically about how this highly~     vulnerable subgroup of smokers may respond to a nicotine reduction policy. This project is~     designed to fill that substantial knowledge gap.~   "
101961|NCT02232724|"~     Prostate cancer is currently the leading newly diagnosed cancer in the industrialized world.~     Treatment of prostate cancer is highly dependent on the stage of the disease. Current methods~     for staging of bone metastases are known to be inaccurate. Staging of lymph nodes requires~     surgery associated with risk of bleeding etc. Prior studies from our department suggest that~     PET/CT is useful in staging of bone metastases in patients with prostate cancer. The aim of~     this study is to compare the usefulness of Dual time point FDG PET/CT with current methods~     for the staging of bone and lymph node metastases in patients with newly diagnosed prostate~     cancer.~      Better initial staging will result in better treatment of the individual patient. If we are~     able to develop a more accurate and non-invasive method of staging patients with undetected~     metastases on current staging will be spared of the side-effects associated with current~     treatment and staging- impotence, incontinence, radiation damage, bleeding, infection etc.~   "
101962|NCT02232711|"~     The purpose of this study is to assess the accuracy and ease-of-use of a simplified FilmArray~     Respiratory Panel test (FilmArray RP EZ) when performed according to the manufacturer's~     instructions by personnel in laboratories holding Clinical Laboratory Improvement Amendments~     (CLIA) waivers (or equivalent) on nasopharyngeal swab samples obtained from volunteers with~     signs and/or symptoms of a respiratory infection. The study data will be used to support an~     application to the FDA for CLIA-waived categorization of FilmArray RP EZ. It is hypothesized~     that the results of the FilmArray RP EZ test performed in a laboratory with CLIA waiver with~     be 95% accurate when compared to FilmArray RP testing performed in a lab with a moderate or~     high complexity CLIA certification.~   "
101963|NCT02232698|"~     The purpose of this study is to evaluate the impact of the Abbott Sensor Based Glucose~     Monitoring System on hypoglycaemia compared to Self Monitoring Blood Glucose (SMBG) testing~     using a randomised controlled study design in adults with Type 1 diabetes using insulin.~   "
101964|NCT02232685|"~     Prostate cancer is currently the leading newly diagnosed cancer in the industrialized world.~     Treatment of prostate cancer is highly dependent on the stage of the disease. Current methods~     for staging are known to be inaccurate. Prior studies from our department suggest that PET/CT~     is useful in staging of bone metastases in patients with prostate cancer. The aim of this~     study is to test the usefulness of Choline PET/CT for the staging of bone metastases compared~     to current standard methods in patients with newly diagnosed prostate cancer.~      Better initial staging will result in better treatment of the individual patient. If we are~     able to develop a more accurate method of staging patients with undetected metastases on~     current staging will be spared of the side-effects associated with current treatment -~     impotence, incontinence, radiation damage etc.~   "
101965|NCT02232672|"~     Prostate cancer is currently the leading newly diagnosed cancer in the industrialized world.~     Treatment of prostate cancer is highly dependent on the stage of the disease. Current methods~     for staging of bone metastases are known to be inaccurate. Staging of lymph nodes requires~     surgery associated with risk of bleeding etc. Prior studies from our department suggest that~     PET/CT is useful in staging of bone metastases in patients with prostate cancer. The aim of~     this study is to compare the usefulness of MeAIB PET/CT with current methods for the staging~     of bone and lymph node metastases in patients with newly diagnosed prostate cancer.~      Better initial staging will result in better treatment of the individual patient. If we are~     able to develop a more accurate and non-invasive method of staging patients with undetected~     metastases on current staging will be spared of the side-effects associated with current~     treatment and staging- impotence, incontinence, radiation damage, bleeding, infection etc.~   "
101966|NCT02232659|"~     The SynCardia 70cc temporary Total Artificial Heart (TAH-t) is approved by the U.S. Food and~     Drug Administration (FDA) for use as a bridge to transplant for patients at risk of imminent~     (about to happen) death from irreversible biventricular heart failure.~      The purpose of this research study is to evaluate whether the TAH-t can support patients with~     life-threatening irreversible biventricular heart failure who are not eligible for~     transplantation. The TAH-t, when used for patients who are not eligible for transplant, is~     considered to be an investigational (not approved by FDA) use. This use is called destination~     therapy (DT).~      Nineteen (19) patients with life-threatening, biventricular failure who are not eligible for~     cardiac transplant will be enrolled in the Primary Arm of the study and followed for up to~     six months post-TAH-t implant. Safety will be evaluated by reviewing the adverse events that~     are experienced by the enrolled subjects and comparing them to previous experience of TAH-t~     patients who were waiting for a heart transplant. Since approximately 74% of patients with~     this condition would not be expected to live beyond six months, the benefit of the TAH-t for~     DT will be confirmed based on survival to six months without experiencing permanent disabling~     stroke-related deficits. After the six month follow-up visit, patients will continue to be~     followed under the study for up to five (5) years postTAH-t implant [every six months for up~     to two years while supported with the TAH-t implant and then annually for another three~     years].~      Up to an additional 19 patients may be enrolled in the Secondary Arm of the study to further~     characterize the use of the TAH-t for DT in a broader patient population. Follow-up would be~     the same for patients enrolled in both arms of the study.~   "
101967|NCT02232646|"~     This is an open label, multi-center, Phase II study of BBI503 administered to adult patients~     with selected advanced urologic malignancies. The primary objective of this study is to~     evaluate the disease control rate of patients with renal cell cancer and urothelial carcinoma~     treated with BBI503.~   "
101968|NCT02232633|"~     This is an open label, multi-center, phase II study of BBI503 administered to adult patients~     with advanced hepatobiliary cancer who have exhausted all currently approved standard~     anti-cancer treatment options. BBI503 will be administered orally, daily, in continuous~     28-day cycles at a dose of 300 mg once daily. Cycles will be repeated until patients are no~     longer clinically benefiting from therapy.~      Safety, efficacy and tolerability of BBI503 will be assessed for the duration of study~     treatment.~   "
101969|NCT02232620|"~     This is an open label, multi-center, phase II study of BBI503 administered to adult patients~     with advanced gastrointestinal stromal tumor who have exhausted all currently approved~     standard anti-cancer treatment options. BBI503 will be administered orally, daily, in~     continuous 28-day cycles at a dose of 300 mg once daily. Cycles will be repeated until~     patients are no longer clinically benefiting from therapy due to disease progression, adverse~     events, or another discontinuation criterion.~      Safety, tolerability and efficacy of BBI503 will be assessed for the duration of study~     treatment.~   "
101970|NCT02232607|"~     The aim of this study was to explore whether lacidipine at doses of 2 mg, 4 mg and 6 mg~     decreased the symptoms of angina, compared to placebo in patients with chronic stable angina~   "
101971|NCT02232594|"~     The aim of this postmarketing surveillance is to obtain further information about the~     tolerability and efficacy of Berodual® metered-dose inhaler in the treatment of chronic~     obstructive respiratory tract disease under conditions of daily practice~   "
101972|NCT02232581|"~     The primary objective was to determine the mean change in HIV viral load from baseline to~     Week 4 compared with placebo after 4 weeks of treatment in highly experienced HIV-infected~     patients.~      Secondary objectives were to determine (1) the tolerability, hematologic and hepatic safety~     of different doses of alovudine and (2) the effect of baseline nucleoside genotypic~     susceptibility on virologic response after 4 weeks of alovudine administration~   "
101973|NCT02232568|"~     Trial of Feedback on Blood Use (TOFU)~      The TOFU study will represent the first attempt to rigorously assess the impact of~     audit-feedback on changing transfusion practice. The primary hypothesis is that providing~     individual feedback on transfusion practice to orthopedic surgeons will reduce elective RBC~     transfusions in the postoperative period.~      TOFU is a two-arm, cluster-randomized controlled trial. Initially, baseline blood use data~     will be collected at all study sites. Next, the PI at each site will give a short educational~     presentation to the orthopedic surgeons. The presentation will consist of a standardized~     10-minute presentation reviewing the data from the FOCUS trial and the recommended red blood~     cell (RBC) transfusion trigger of 8 g/dL (or symptomatic anemia) based on that data. Clusters~     of orthopedic surgeons will then be randomized to either the Control arm (no feedback) or the~     Intervention arm (monthly feedback). All of the surgeons at a given site will either receive~     or not receive feedback. The feedback will take the form of emailed monthly reports detailing~     blood use by each surgeon post-hip surgery. Surgeons will be anonymized in the reports as A,~     B, C . . . but each surgeon will know which data are his own. The primary end point is the~     decrease from baseline in the proportion of patients transfused with a pretransfusion~     hemoglobin of > 8 g/dL.~      TOFU will be conducted at 8 sites in Europe and North and South America. Care has been taken~     to minimize the labor and costs required to conduct this study. The only data collected will~     be: patient age/gender; procedure; surgeon (anonymized); surgery & discharge dates; RBC units~     transfused; Hgb levels. The data will be entered at each site into a web-based Case Report~     Form, and will be stored centrally by the Data Coordinating Center (DCC). The DCC will~     generate monthly feedback reports and email them to each Intervention arm site PI. The site~     PI will then email the reports to each local orthopedic surgeon.~   "
101974|NCT02232555|"~     The purpose of this study was to investigate the efficacy of duloxetine versus placebo on~     pain in outpatients with major depressive disorder (MDD): change in Brief Pain Inventory~     Short Form (BPI-SF) 24-hour average pain score from baseline over the 8 weeks of treatment~   "
101975|NCT02232542|"~     Study to assess the safety and tolerability of 100 mg of duloxetine BID compared to 40 mg of~     duloxetine BID or placebo for 7 days~   "
101976|NCT02232529|"~     The aim of the study is to assess how MIN-101 is taken up by the body when given in different~     amounts and in different formulations. The drug will be given as a single dose in Part 1 of~     the study and during Part 2 of the study as multiple dose, once daily for 7 days. The~     ultimate aim is to find an optimal formulation which can be developed as a once daily dose~     for the treatment of schizophrenia.~   "
101977|NCT02232516|"~     The purpose of this study is to evaluate how safe and effective the combination of the study~     drugs romidepsin and lenalidomide is for treating patients with peripheral t-cell lymphoma~     (PTCL) who have not been previously treated for this cancer. Currently, there is no standard~     treatment for patients with PTCL; the most common treatment used is a combination of drugs~     called CHOP, but this can be a difficult treatment to tolerate because of side effects, and~     is not particularly effective for most patients with PTCL. Romidepsin (Istodax®) is a type of~     drug called an HDAC inhibitor. It interacts with DNA (genetic material in cells) in ways that~     can stop tumors from growing. It is given as an infusion through the veins. Lenalidomide~     (Revlimid®) is a type of drug known as an immunomodulatory drug, or IMID for short. This drug~     affects how tumor cells grow and survive, including affecting blood vessel growth in tumors.~     It is given as an oral tablet (by mouth).~   "
101978|NCT02232503|"~     The aim of the study is to find out prevalence and individual stages of Diabetic Retinopathy~     in patients with type 1 and type 2 DM verified based on complex ophthalmologic measurements~     in Slovak Republic. The outcome of the project will be epidemiology survey, prevalence of~     diabetic retinopathy (DR) and diabetic macular edema (DME) in relation to type and duration~     of diabetes mellitus and risk factors. Project will also identify genetic factors linked with~     the diseases.~   "
101979|NCT02232490|"~     Phase III, randomized, placebo-controlled, double-blinded trial aimed to seek the therapeutic~     benefit of hepcortespenlisimut-L (Hepko-V5) in subjects with advanced hepatocellular~     carcinoma.~   "
101980|NCT02232477|"~     This is a five-year extension study of the pilot study, Intrathecal Enzyme Replacement for~     Cognitive Decline in MPS I. Participants must have completed the pilot study to participate~     in this study.~   "
101998|NCT02232243|"~     Baseline levels of PAR-4 secreted by normal cells are generally inadequate to cause massive~     apoptosis in cancer cells and drugs that bolster the secretion of PAR-4 would constitute an~     important therapeutic advance.The apoptosis sensitizing features of hydroxychloroquine~     enhance the anti-tumor effects of a broad range of cancer therapeutics. The investigators~     hypothesize that hydroxychloroquine will induce at least 2-fold increase in systemic (plasma)~     PAR-4 levels compared to pre-treatment plasma levels in patients with resectable solid~     tumors.~   "
101999|NCT02232230|"~     Radiation in combination with Provenge based immunotherapy may improve outcomes seen on~     imaging as well as immunologic monitoring. This study will assess the effect of radiation~     therapy to augment anti-tumor responses from immune therapy with Provenge.~   "
101981|NCT02232464|"~     Attention deficit/hyperactivity disorder (ADHD) is a common, impairing, childhood onset~     neuropsychiatric disorder with executive dysfunctions. The ADHD symptoms and executive~     deficits may last to adulthood. Our previous studies, like western results, have shown that~     children with ADHD have disrupted microstructural integrity of frontostriatal fiber pathways~     and impaired brain activity in frontoparietal network. However, there is lack of data with~     regards to whether adults with ADHD also demonstrate structural and functional~     disconnectivity of frontostriatal and frontoparietal networks as compared to healthy controls~     without ADHD in Asian population and no study has been done to correlate a wide range of~     executive functions with the connectivity of these two networks.~      Specific Aims:~        1. to compare the executive functions, and structural and functional connectivity in~          frontostriatal and frontoparietal circuitries between adults with ADHD and healthy~          controls without ADHD;~        2. to correlate the data from structural and functional connectivity, executive functions,~          and ADHD core symptoms stratifying by the ADHD and controls; and~        3. to explore other circuitries that may involve in ADHD by using whole brain tractography~          analyses.~   "
101982|NCT02232451|"~     The purpose of this study is to test a new guide-wire (loop-tip wire) with a loop in the tip~     for the prevention of PEP and biliary tree access, in post-ERCP pancreatitis in high-risk~     patients.~   "
101983|NCT02232438|"~     At present, there are no established treatments for depression or anxiety in adolescents with~     cancer, creating an important clinical and research gap. Fortunately, there is now~     substantial evidence documenting the efficacy of psychotherapy in the treatment of depressed~     and anxious adolescents in the general population.~   "
101984|NCT02232425|"~     The purpose of this study is to determine the effectiveness of IX-01 in men with lifelong~     premature ejaculation.~   "
101985|NCT02232412|"~     Critically ill patients are frequently transfused with red blood cell (RBC) units with the~     predominant intention to increase arterial oxygen content and thus oxygen delivery to the~     tissues.~      To date, RBC transfusions have been proven effective in patients with profound anaemia or~     circulatory shock. However, the impact of the storage process and the so-called storage~     lesion on oxygen-carrying properties and, hence, the efficacy of RBC transfusion regarding~     tissue oxygenation are much debated at present. Alterations of RBC physiology have been~     comprehensively described ex vivo. Reduced deformability, increased adhesiveness and~     aggregability of stored RBC impair their rheological properties; anaerobic cellular~     metabolism with reduced contents of 2,3 bisphosphoglycerate and adenosine triphosphate (ATP)~     increases oxygen affinity and impairs oxygen release to the tissues.~      This study aims to monitor the effect RBC transfusion has on the regional cerebral oxygen~     saturation (rSO2) of critically ill patients. rSO2 will be measured indirectly, using near~     infrared spectroscopy (NIRS) . Patients will be monitored once it looms that they might~     require RBC transfusion. The monitoring is continued for the time of transfusion and the~     hours afterwards.~   "
101986|NCT02232399|"~     The aim of the study is to assess the ability of Levosimendan to reduce the postoperative~     acute kidney injury in pediatric patients undergoing surgery for congenital heart disease~     (CHDs). Young children, between the age of 1 to 12 months, with congenital heart disease in~     need of elective heart surgery will be included in this study.~      The trial will contain two study groups, 35 patients in each. One group will receive~     Levosimendan and the second group will receive Milrinone as a heart muscle-strengthening~     agent during and after the operation. Milrinone is currently used as the drug of choice in~     many pediatric cardiac surgery centers. It remains to see if Levosimendan can exert a kidney~     protecting function in addition to its heart muscle-strengthening properties.~      The primary objective of this study is to investigate the preventive effect of Levosimendan~     on postoperative acute kidney injury in pediatric patients undergoing surgery for their CHDs.~     Creatinine levels postoperatively will be the primary endpoint. Creatinine, the common marker~     of kidney injury, will be measured daily.~      The treatment with Levosimendan or Milrinone will be started during the operation (after~     initiation of cardiopulmonary bypass) and will last 24 hours. Blood samples will be obtained~     at six occasions perioperatively. Patients will be followed 4 days after termination of~     treatment (totally 5 days).~      The duration of study will be 30 days (24 hours treatment + 4 days follow up +~     30-days-mortality registration).~      Creatinine is the primary outcome in this study. Inflammatory biomarkers and other relevant~     biomarkers will comprise the secondary outcome variables.~   "
101987|NCT02232386|"~     The present study aims at evaluating whether treatment with two different drugs, Ibrutinib~     and Rituximab is both efficient and safe for newly diagnosed patients with chronic~     lymphocytic leukemia.~   "
101988|NCT02232373|"~     The purpose of the study is explore the issues that relate to testing a particular dietary~     treatment, the low FODMAP diet, in a randomised trial using an appropriate control diet with~     which to compare it. In this trial the investigators will look at its effect on symptoms of~     people with persistent disturbance in their bowel pattern 3 months after an intestinal~     infection with Campylobacter.~      The investigators will also look at the changes in gut bacteria that occur with the diet.~   "
101989|NCT02232360|"~     The purpose of this study is to determine effects of combination therapy with rosuvastatin~     and fenofibrate on atheromatous plaques and its tissue characteristics of de novo coronary~     lesions with intermediate stenosis in patient with coronary artery disease, compared with~     rosuvastatin alone therapy.~   "
101990|NCT02232347|"~     The objective of the study is to compare the effects of 48 hours ketamine infusion versus~     sufentanil infusion on brain glutamate concentrations measured with microdialysis after~     traumatic brain injury.~      We hypothesize that ketamine infusion will decrease high glutamate values faster than~     sufentanil.~   "
102019|NCT02231970|"~     Emerging endoscopic techniques are minimally invasive and can mimic the anatomic alterations~     achieved by surgical sleeve gastrectomy.~      The study hypothesis is if endoscopic sleeve gastroplasty is effective and useful in the~     treatment of patients with obesity~   "
102032|NCT02231801|"~     This observational study aims to monitor the vital sign changes in both mother and baby that~     occur during kangaroo care in preterm infants and to investigate any potential correlations~     between maternal measurement values and those of the infant. The purpose of this~     observational study is to look for a method to track the earliest responses that could,~     theoretically, be considered as 'social responses' in hopes of providing developmental~     interventions earlier to at-risk infants.~   "
101991|NCT02232334|"~     Global osteopathic manual treatments will decrease the severity score of the Gastroparesis~     Cardinal Symptom Index tool of patients with idiopathic gastroparesis.~      In this longitudinal controlled pre-test post-test group design, subjects with idiopathic~     gastroparesis (IG) will be utilized to see if global osteopathic manual treatments can~     decrease their symptoms. Patients with IG suffer from varying degrees of nausea, vomiting and~     abdominal pain secondary to delayed gastric emptying. There is no known cause for people~     suffering from IG.~      According to the power analysis, the population will be utilized as the experiment group and~     the control group. The measuring tool to be used is the Gastroparesis Cardinal Symptom Index~     (GCSI) which is the most widely used symptom score questionnaire for gastroparesis. The~     subjects in the population will each fill out the GCSI initially and again after an two (2)~     week period to measure their symptoms during a control period. The same subjects will then be~     treated with global osteopathic manual treatments one (1) treatment every two (2) weeks for~     four (4) weeks (day 1, 14, and 28). The GCSI will be filled out on the day of the first (1st)~     treatment (which is the last day of the control period) and then two (2) weeks after the last~     treatment (day 42). In order to reject the null hypothesis, with a p value of < 0.05 and a~     power of 0.8, a minimum of ten (10) subjects in the treatment group is required with a~     treatment effect of 1 or more. A 'Treatment effect of 1' is defined by Cohen's d, where d =~     mean difference/standard deviation.~      It is expected that the results will show improvement of symptoms through the data collected~     from the GCSI questionnaires in the treatment group. The results of this study could be~     significant and contribute to the osteopathic community validating the effectiveness of~     traditional osteopathic manual therapy as well as giving non-invasive options to people~     suffering from the disease since those who struggle with it have minimal treatment~     options--medicines with significant side effects, full or total stomach removal or gastric~     electrical stimulator implants.~   "
101992|NCT02232321|"~     Objectives To investigate the effect of achieving minimal disease activity (MDA) using a~     protocolized treatment strategy on the progression of subclinical atherosclerosis and~     arterial stiffness in psoriatic arthritis (PsA) patients.~      Hypothesis Effective suppression of inflammation in patients who can achieve MDA will have~     less progression of subclinical atherosclerosis and arterial stiffness then patients who~     cannot achieve MDA by means of a standardized treatment algorithm aiming at MDA.~      Design and subjects One hundred consecutive PsA patients will participate in this 2-year~     prospective, hospital-based, cohort study.~      Interventions All participants will receive 2-year tight-control treatment. Treatment will be~     adjusted according to a standardized protocol based on the European League Against Rheumatism~     (EULAR) recommendation and the Hong Kong guideline on the use of biologics every 4-monthly~     aiming at MDA.~      Study instruments Carotid intima-media thickness (IMT) will be measured using high-resolution~     ultrasound. Arterial stiffness is measured using pulse wave velocity (PWV) by a dedicated~     tonometry system and augmentation index (AIx) by the SphygmoCor device.~      Main outcome measures and analysis The main outcome measure is the change in IMT over a~     period of 2 years comparing between patients who achieve MDA at 12 months (MDA group) to~     those who cannot achieve MDA (non-MDA group). Secondary outcomes include differences in the~     changes in AIx and PWV over 2 years between the 2 groups. Comparisons of the changes in IMT,~     AIx and PWV over 2 years between the MDA and non-MDA groups will be performed.~   "
101993|NCT02232308|"~     To assess if oral nizatidine or lisinopril alone and in combination will increase heme~     oxygenase 1 (HO-1) protein concentration and activity compared to placebo in healthy~     subjects.~   "
101994|NCT02232295|"~     The aim of the Study to evaluate the effect of Graded motor imagery on upper limb motor~     functions and quality of life in patients with stroke that was conducted in two centers in~     india. The primary outcome measures were upper limb motor functions at 6 weeks and secondary~     outcome measure was quality of life at 6 weeks.~      Research Hypothesis: There would be significant effect of GMI on Upper limb motor functions~     and quality of life in patients with stroke.~   "
101995|NCT02232282|"~     The investigators central hypothesis is that women with Interstitial Cystitis/Painful Bladder~     Syndrome (IC/PBS) will benefit from acupuncture compared with sham treatment and acupuncture~     responders will have a differential urinary microbiome.~   "
101996|NCT02232269|"~     Hypertension affects an estimated 1.5 billion people world-wide and is a chief contributor to~     death, stroke, congestive heart failure, kidney disease, coronary artery disease and~     dementia. A number of important causal environmental factors have been identified and include~     excessive salt or alcohol consumption, physical inactivity, inadequate fruit, vegetable and~     potassium intake and obesity. Although there have been significant improvements in~     management, a high percentage of patients still do not achieve target blood pressures.~      Coffee is a popular beverage globally and elevates blood pressure variably among individuals.~     Customers in the United States comprise more than half of the population over the age of 18~     years, consume an average of 1 cup (typical size: 270 ml) of coffee three times per day and~     spend an estimated $ 40 billion on the purchase of it each year. A major active constituent~     in coffee is caffeine, which is the most widely used pharmacological substance in the world.~      Drug therapy plays a major role in the management of hypertension. Concomitant intake of~     coffee is likely substantial. However, the interaction between coffee or caffeine and blood~     pressure lowering drugs has been assessed in only a few clinical studies conducted more than~     two decades ago. Moreover, it appears to have the potential to confound the routine drug~     management of hypertension.~      This clinical investigation reports the actions of a customary amount of coffee on the~     circulatory effects and blood concentrations of felodipine, a drug belonging to a class of~     drugs commonly used to treat hypertension. Application of results from this study to clinical~     practice has the possibility to improve the management of hypertension.~   "
101997|NCT02232256|"~     California Poppy has been traditionally used in Herbal Medicine as an analgesic, mild~     sedative and/or sleep aid. However there are no human clinical trial data to support its use.~     Sleep disturbances are a well-recognized component of chronic pain, and lead to additional~     social withdrawal, greater pain and worsening depression. Most hypnotics available either~     place the patient at further risk (e.g. benzodiazepines combined with opioids increase the~     risk of central or obstructive sleep apnea), increase adverse events (dry mouth, daytime~     somnolence, etc.) or induce sleep but do not improve the quality of sleep (no increase in~     Rapid Eye Movement or curative sleep). This study intends to use California Poppy to avoid~     adverse effects while improving sleep. An open-label clinical trial was performed to obtain~     preliminary safety and efficacy information of California poppy. This trial was approved by a~     central ethics review board. The study results showed that California poppy, can be used as a~     co-analgesic to provide additional analgesia and/or sleep improvement to the patient.~     Patients who are referred to the clinic will be asked to complete a few short questionnaires~     at every visit and on monthly basis respectively. This data, in addition to the usual~     follow-up questionnaires used by the clinics' physicians (McGill Pain Intensity, Pain~     Disability Index, Short-form Health Survey-12v2) and general demographic and medical~     information will be used to assess California Poppy's effectiveness on patients~   "
102000|NCT02232217|"~     The purpose of this study is to conduct a randomized controlled trial (RCT) to evaluate the~     efficacy of brief cognitive behavioral treatment for child sleep (CBTcs) to improve sleep in~     an important high-risk population, overweight/obese (OV/OB) youth with behavioral sleep~     disorders. OV/OB youth with behavioral sleep disorders and their parent(s) will be randomly~     assigned to 8 sessions of either CBTcs or an Educational Control (EC). CBTcs will address~     behavioral sleep issues in children; EC will address sleep and dietary education and general~     coping strategies. Child sleep (total wake time, total sleep time, bed/wake times), height,~     weight, physical activity, dietary intake, quality of life (QOL), fatigue, and daytime~     sleepiness will be assessed at baseline, post-treatment, and 3-month follow-up. It is~     hypothesized the children in the CBTcs will experience greater improvement in sleep than~     children in the EC.~   "
102001|NCT02232204|"~     This is a single-center, randomized controlled trial study design. Enrolled participants have~     a cardiovascular condition for which they are undergoing implantable cardioverter~     defibrillator (ICD) therapy and comorbid insomnia. Participants were randomized to a~     behavioral intervention for insomnia in ICD patients or a waitlist control. The treatment~     intervention period lasted 4 weeks with a telephone booster session administered at 3 month~     follow-up. The objective of the study is to examine the impact of a brief therapy combining~     established behavioral approaches to treating insomnia with novel components to target~     negative cognitions and anxieties associated with cardiac disease and ICD implantation.~     Primary patient outcomes include sleep, psychological functioning, daytime functioning,~     cardiac functioning, cognitive performance, and ICD adjustment.~   "
102002|NCT02232191|"~     Persons without a spleen are susceptible to potentially lethal infections from certain~     bacteria, with pneumococcus being the most prevalent. Vaccines are provided to help protect~     against these infections, though they do not so with certainty. Trauma patients who sustain~     an injury to their spleen currently have three treatment options available for the treating~     surgeon - nonoperative management, embolization, or removal of the spleen. The purpose of~     this study is to investigate the antibody response to pneumococcal vaccine in patients~     undergoing these modes of therapy.~   "
102003|NCT02232178|"~     Assess the pharmacokinetic profile of 2 doses of the XaraColl® implant after open laparotomy~     hernioplasty and assess the relative bioavailability of Xaracoll compared to a local~     bupivacaine infiltration.~   "
102004|NCT02232165|"~     Current guidelines for the clinical management of acute spinal cord injury (SCI) recommend~     maintenance of mean arterial blood pressure (MAP) at 85 to 90 mmHg for the first seven days~     after SCI as a clinical option. Unfortunately, the medical evidence to support this~     recommendation exists only at the clinical case series level (Class III data). Furthermore,~     maintenance of sustained systemic hypertension, as per clinical guidelines, may be associated~     with risks to the patient via adverse medical events. Given this equivocal evidence, the~     investigators group has questioned the merit of sustained induced hypertension following~     acute SCI and has previously conducted a randomized, prospective controlled feasibility study~     to further examine this issue. This prior pilot study randomized patients with acute SCI to a~     spinal cord perfusion pressure (SCPP = MAP - intrathecal pressure (ITP)) target of ≥ 75 mmHg~     or to a control group (hypotension avoidance, MAP ≥ 65 mmHg). The primary endpoint measure~     was defined as the change in American Spinal Injury Association (ASIA) motor score from~     baseline. No difference in the primary outcome was noted at one-year post-SCI in this study.~      In light of this pilot data, the investigators hypothesize that maintenance of normotension~     (MAP ≥ 65mmHg) is not inferior to induced hypertension (MAP ≥ 85mmHg) for 7 days following~     acute SCI. As such, the investigators propose to conduct a Phase III non-inferiority~     prospective, randomized clinical trial in acute SCI patients. Subjects will be randomized~     into one of two MAP management groups for 7 days; Group 1 will be managed with a target MAP ≥~     65 mmHg, while Group 2 will be managed with a target MAP ≥ 85 mmHg. The primary endpoint will~     be change in ASIA motor score from baseline at 12 months post injury. A difference of ≤10~     ASIA motor points change from baseline between groups will be considered as non-inferiority.~     Secondary endpoints will include ASIA sensory score, proportion of patients achieving a one~     grade improvement in ASIA impairment scale, quality of life assessment (as measured by~     Short-Form-36 [SF-36]) and functional outcome (as measured by the Spinal Cord Independence~     Measure (SCIM) and Functional Independence Measure (FIM). These will be measured at baseline,~     72 hours and 3, 6 and 12 months from injury. Adverse events will be meticulously recorded.~     The information gleaned from this trial will provide valuable information for the acute~     treatment of traumatic SCI and will serve the objective of optimizing current clinical~     practice and thus maximizing medical and neurological outcome for individuals following acute~     traumatic SCI.~   "
102005|NCT02232152|"~     This pilot phase I trial studies the side effects and best dose of CPI-613 when given~     together with fluorouracil in treating patients with colorectal cancer that has spread to~     other parts of the body and cannot be removed by surgery. CPI-613 may kill tumor cells by~     turning off their mitochondria. Mitochondria are used by tumor cells to produce energy and~     are the building blocks needed to make more tumor cells. By shutting off these mitochondria,~     CPI-613 deprives the tumor cells of energy and other supplies that they need to survive and~     grow in the body. Drugs used in chemotherapy, such as fluorouracil, work in different ways to~     stop the growth of tumor cells, either by killing the cells, by stopping them from dividing,~     or by stopping them from spreading. Giving CPI-613 with fluorouracil may kill more tumor~     cells.~   "
102006|NCT02232139|"~     The aim of the investigation is to validate the SmartPhone-based 4-Reaction Choice Time Test~     (4CRT) as a measure for recovery of the psychomotor function in patients after general~     anesthesia. One hundred female patients, scheduled to ambulatory gynecological surgery in~     general anesthesia, will be randomized to the group with pharmacological anxiolytic~     premedication with midazolam (N=50) and to the group without midazolam (N=50). All patients~     will be monitored using 4CRT before and after standardized general anesthesia. The reaction~     time, measured with 4CRT is the primary outcome parameter of the investigation.~   "
102020|NCT02231957|"~     There are a growing number of adolescents with chronic medical conditions in the United~     States. The Advisory Committee on Immunization Practices (ACIP) recommends HPV vaccination~     and annual influenza vaccination of all adolescents. Pneumococcal polysaccharide vaccination~     is also recommended for certain high-risk patients. Limited studies suggest that vaccination~     coverage of this population remains sub-optimal. Text message vaccine reminder/recall has~     been shown to be effective in increasing uptake of select pediatric and adolescents vaccines,~     but has yet to be examined among patients with chronic medical conditions who may also face~     unique barriers to vaccination. This intervention aims to implement and evaluate the use of~     text message vaccine reminders among urban low-income minority adolescents with chronic~     medical conditions. This investigator-initiated study is supported in part by a grant from~     the Pfizer Medical Education Group.~   "
102021|NCT02231944|"~     To compare the first and second recovery assessments on Replenine®-VF and to evaluate~     recovery of different batches if patients changed batches during the study.~      To evaluate Replenine®-VF in terms of long-term clinical efficacy, tolerance and safety~   "
102022|NCT02231931|"~     To investigate the mutual interaction potential of digoxin, furosemide, metformin, and~     rosuvastatin when given alone or together as a cocktail, and to investigate the effect of~     high doses of metformin or furosemide on pharmacokinetics of the other cocktail compounds~   "
102007|NCT02232126|"~     In response to Program Announcement (PA)-09-164, NIH Exploratory/Developmental Research~     Grant Program (R21) a randomized pilot study testing the efficacy of SWIFT: Social Work~     Intervention Focused on Transitions among at-risk older adults following hospital discharge~     to home. This study is drawn from several observations. First, transitions between care~     settings create elevated risk for poor outcomes and for readmission among older adults~     leaving the hospital for home largely due to fragmented care and poor communication. Next,~     while few studies exist that test methods to improve transitions, those available are largely~     medically focused, using a nurse or advanced practice nurse in their approach. Although~     evidence exists to support the effectiveness of these models, few have been replicated and~     none have been integrated into standard health care practice. This may be attributed to~     several factors including the availability of the needed staff, the lack of existing~     structures to support these roles, and the costs of implementing these interventions.~     Finally, a social work driven intervention may provide a replicable mechanism for bridging~     medical care, addressing psychosocial needs as well as medical needs, and improving linkages~     with community services while reducing care duplication. This study aimed to test a~     structured social work transition intervention model to reduce rates of hospital readmission~     and medical service use while improving patient satisfaction with the care transition~     process. A randomized pilot study was used to test a social work transitions model designed~     to improve care provided to frail older adults being discharged from the hospital to return~     to the community. Eligible patients consenting to participate (n=181) were randomly assigned~     to either the social work transitions model intervention or usual care. This project was~     conducted at Huntington Hospital, a 525-bed, nonprofit, community hospital located in~     Pasadena, California. In an average year, Huntington Hospital has approximately 10,000 older~     adults discharged from their facility, 44% of who are 80 years old or older. Those randomized~     to the intervention arm received up to six sessions from the social worker, at least one~     provided in the home. The social work intervention was designed to overcome common problems~     following hospital discharge including medication review, discussion and planning around~     discharge instruction, assistance in scheduling follow up appointments, assessments of~     psychosocial and other support service needs and provision of linkages to address those~     needs. Outcomes were measured three and six months following arrival at home, with an interim~     measure of satisfaction at 10 days following arrival at home, with measures including patient~     level of depression, pain, physical functioning, self-efficacy with disease management, and~     medical service use.~   "
102008|NCT02232113|"~     The response of Continuous Erythropoietic Receptor Activator (CERA) with different dose~     interval and the survey for influence factors:~      We aim to evaluate a better clinical response which can be achieved by different dosing~     interval of a fixed dose of CERA. We expect this study can determine the dosing schedule with~     better clinical response to CERA and identify the associated factors predicting the~     cost-effectiveness of CERA in maintenance hemodialysis (HD) patients in Taiwan.~   "
102009|NCT02232100|"~     Chronic musculoskeletal pain is a complex medical condition associated with significant~     distress, disability, and reduction in quality of life. Research has shown that patients with~     chronic musculoskeletal pain demonstrate attentional biases towards pain-related information.~      The purpose of this study is to determine whether internet-delivered attentional bias~     modification, which aims to implicitly train attention away from pain-related information,~     has beneficial effects upon pain and pain-related distress in patients with chronic~     musculoskeletal pain.~      Participants will be randomised to either an attentional training condition, or to a~     no-training placebo condition. The primary outcome measures are pain intensity and pain~     interference, and secondary outcome measures include anxiety, depression, pain-related fear~     and sleep problems.~      It is hypothesized that participants receiving internet-delivered attentional bias~     modification will show significantly greater reductions in pain and pain-related distress~     compared to participants receiving placebo training.~   "
102010|NCT02232087|"~     The purpose of this study is to test the body's response to several doses of two different~     inhalation products in healthy volunteers.~   "
102011|NCT02232074|"~     The investigators plan to compare standard patient navigation with an enhanced navigation~     partnered with the Medical Legal Partnership | Boston (MLP) to determine if assessing legal~     needs of newly diagnosed cancer patients in addition to other barriers to care leads to~     better clinical outcomes.~   "
102012|NCT02232061|"~     This study will evaluate if patients who had a serious cardiovascular event upon initiation~     of fingolimod are at risk to delevop long term other cardiovascular events~   "
102013|NCT02232048|"~     Patients hospitalized in internal medicine departments are given corticosteroid treatment~     according clinical indications. Patients receive treatment at different dosage levels and in~     different preparations according to clinical indications. This study will investigate how~     corticosteroids effect the heart and specifically, longitudinal strain.~   "
102014|NCT02232035|"~     Prolonged labour can lead to increased maternal and neonatal mortality and morbidity due to~     increased risks of maternal exhaustion, postpartum haemorrhage and sepsis, fetal distress and~     asphyxia and requires early detection and appropriate clinical response. The risks for~     complications of prolonged labour are much greater in poor resource settings. Active~     management of labour versus physiological, expectant management, has shown to decrease the~     occurrence of prolonged labour. Administering sedatives during labour could also lead to~     faster and more effective dilatation of the cervix. Interventions to shorten labour, such as~     sedatives, can be used as a preventative or a treatment strategy in order to decrease the~     incidence of prolonged labour. As the evidence to support this is still largely anecdotal~     around the world. (Cochrane Database of Systematic Reviews 2013,CD009243.pub3.; Cochrane~     Database of Systematic Reviews 2012, CD009223.pub2.)~      Hypothesis: Diazepam reduced the duration of labor and the severity of pain in labor.~   "
102015|NCT02232022|"~     The purpose of this study is to determine the incidence of paroxysmal atrial fibrillation~     (AF) in ischemic stroke patients who have a presumed known stroke etiology other than atrial~     fibrillation.~   "
102016|NCT02232009|"~     This study investigates a novel magnetic resonance imaging (MRI) system designed by GEHC for~     imaging viable neonate and infant populations. This MR system has a smaller size and design~     features that may make it more feasible to locate the system in close proximity to care areas~     for neonates (birth - 1 month) and infants (less than 1 month to two years), such as clinical~     neonatal intensive care units (NICUs) and other infant and neonatal care departments.~   "
102017|NCT02231996|"~     CGD is a rare inherited primary immunodeficiency which is caused by the defect in one of the~     subunits of NADPH oxidase complex.We tend to collect and analyze Chinese CGD patients who are~     diagnosed in hospitals affiliated to Shanghai Jiao Tong University School of Medicine,~     including clinical feature, laboratory data and genetic information. we aim to find out~     clinical, distribution, genetic characteristic of CGD in Chinese population, etc., thus~     further improving the level of diagnosis and treatment for CGD.~   "
102018|NCT02231983|"~     Severe combined immunodeficiency (SCID), a rare primary immunodeficiency dieases (PID), is~     poorly characterized in mainland China. We meant to explore the patients with SCID refered to~     our hospital and summarize their clinical manifestations and genetic features.~   "
102023|NCT02231918|"~     Study to determine the pharmacokinetics (PK) of pramipexole (PPX) after administration of a~     single dose orally (p.o.) in pediatric patients with the diagnosis of RLS~   "
102025|NCT02231892|"~     Background:~      - Brain stimulation called repetitive transcranial magnetic stimulation (rTMS) may help~     people quit drugs. Researchers want to study how it works in healthy people first.~      Objective:~      - To learn how to use rTMS to stimulate a brain area and to see how it affects brain function~     and thinking.~      Eligibility:~      - Healthy, right-handed adults ages 18-55.~      Design:~        -  Participants will be screened under another protocol.~        -  They will have 4-11 study visits.~        -  To start each visit, participants will have:~        -  Physical exam.~        -  Urine sample.~        -  Breath tests for alcohol and cigarette smoke.~        -  Questions about drug use and medications.~        -  Visit 1: participants will have:~        -  Single TMS pulses on the head to determine the right strength. They will wear earplugs~          and a cap. A wire coil will be placed on the head and an electrical current will go~          through it. Participants may perform simple muscle movements. They will repeat the~          procedures wearing another coil, in a helmet.~        -  A few TMS pulses to show how rTMS feels.~        -  A practice thinking task, maybe in a scanner that looks and sounds like a magnetic~          resonance imaging (MRI) scanner but does not take pictures. The MRI scanner is a metal~          cylinder surrounded by a strong magnetic field. The participant will lie on a table that~          slides in and out of the cylinder.~        -  They may have a real MRI scan.~        -  Visits 2-11, participants will:~        -  Complete two questionnaires.~        -  Get varied rTMS stimulation. Their heart rate and blood pressure may be monitored.~        -  Have their vital signs checked.~        -  They may perform thinking tasks at a computer, in a mock scanner, or in an MRI scanner.~          They may just lie still in the MRI scanner.~   "
102026|NCT02231879|"~     Background:~      - WHIMS (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis Syndrome) is a rare~     disease. It can cause cancers, infections, and warts. Researchers want to see if a drug~     called plerixafor can treat WHIMS.~      Objective:~      - To compare plerixafor versus granulocyte colony stimulating factor (G-CSF) for preventing~     infections in people with WHIMS.~      Eligibility:~      - People ages 10 75 with WHIMS who have a CXCR4 gene mutation.~      Design:~        -  Participants will be screened with a medical history, physical exam, and blood and urine~          tests. They may have heart and spleen tests and body scans. They may have samples of~          skin or warts taken. Researchers may take photographs of warts.~        -  Participants will start twice daily self-injections of G-CSF. Their doctors will decide~          the dosage.~        -  Initial Period (4 12 weeks)~        -  Participants will:~        -  continue the injections and their usual antibiotics and/or immunoglobulin~        -  have blood drawn~        -  keep a daily health diary~        -  Participants will visit the clinic for 2 days without injections.~        -  Adjustment Period 1 (8 weeks):~        -  Participants will:~        -  continue twice daily injections from home~        -  continue the daily health diary~        -  have blood tests every 2 weeks.~        -  Treatment Year 1:~        -  Participants will~        -  receive either plerixafor or G-CSF injections twice daily~        -  continue the health diary~        -  have blood tests every 2 months~        -  visit the clinic about every 4 months~        -  At the end of year 1, participants will visit the clinic for an evaluation. They will~          switch to the other study drug. They will have an 8-week adjustment and 1-year treatment~          period.~        -  At the end of year 2, participants will visit the clinic to complete their injections~          and go back to their previous G-CSF regimen. Participants will continue their daily~          health diary and have blood tests for 5 6 months.~   "
102027|NCT02231866|"~     Background:~      - Ebola virus causes an infection known as Ebola virus disease (EVD). This it is generally a~     severe disease which can also lead to death. The 2014 outbreak of EVD in West Africa is the~     largest ever. Researchers want to develop a vaccine to prevent Ebola infection. It is~     impossible for someone to get an Ebola infection from this vaccine.~      Objectives:~      - To see if an Ebola vaccine is safe and to study immune responses to it.~      Eligibility:~      - Healthy adults ages 18-65.~      Design:~        -  Participants will be screened through a separate protocol.~        -  Participants will receive the vaccine injection by needle and syringe into an upper arm~          muscle. - Participants will stay at the clinic for 3 hours after the injection.~        -  About 2 days later, participants must speak with clinic staff about how they are doing.~        -  Every day for 7 days after the injection, participants will record their temperature and~          symptoms and look at the injection site. They will get a thermometer and a ruler to~          measure any redness or swelling. They will report any side effects.~        -  In the first 2 months in the study, participants will have at least 6 clinic visits and~          1 phone call. They will have at least 3 other visits over the next 9 months.~        -  At each visit, participants will be checked for health changes or problems since their~          last visit. They will be asked how they feel and if they have taken any medicine. Blood~          will be drawn at most visits. Urine samples may be collected.~   "
102028|NCT02231853|"~     Allogeneic hematopoetic stem cell transplantation (SCT) is frequently complicated by life~     threatening viral reactivation. Conventional antiviral therapy is suboptimal for~     cytomegalovirus (CMV), adenovirus (AdV) and Epstein-Barr virus (EBV) and nonexistent for BK~     virus (BKV). An alternative approach to prevent viral reactivation is to infuse~     virus-specific cytotoxic T cells (CTL) prepared from the donor early after SCT. Such~     multivirus-specific CTL cells (MVST) have been successfully used in a number of centers to~     prevent or treat CMV, Ad and EBV. Activity of BKV-reactive cells has not been studied. Multi~     virus-specific T cells (MVST) are donor lymphocytes that are highly enriched for viral~     antigens and expanded in vitro before infusion into the transplant recipient. Viral~     reactivation is a particular problem inT cell depleted SCT. Median time to CMV reactivation~     is estimated as 28 days post T-depleted transplant, but infusion of MVST within the immediate~     post-SCT period has not been previously studied. This protocol will be the first of a planned~     series of cellular therapies to be layered on our existing T lymphocyte depleted transplant~     platform protocol 13-H-0144.~      The aim of this study is to determine the safety and efficacy of very early infusion of MVST~     directed against the four most common viruses causing complications after T-depleted SCT.~     GMP-grade allogeneic MVST from the stem cell donor will be generated using monocyte-derived~     donor dendritic cells (DCs) pulsed with overlapping peptide libraries of immunodominant~     antigens from CMV, EBV, Ad, and BKV and expanded in IL-7 and IL-15 followed by IL-2 for 10-14~     days. A fraction of the routine donor leukapheresis for lymphocytes obtained prior to stem~     cell mobilization will be used to generate the MVST cells. MVST passing release criteria will~     be cryopreserved ready for infusion post SCT.~      Eligible subjects on NHLBI protocol 13-H-0144 will receive a single early infusion of MVST~     within 30 days (target day +14, range 0-30 days) post SCT. Phase I safety monitoring will~     continue for 6 weeks. Viral reactivation (CMV, EBV, Ad, BK) will be monitored by PCR by~     serial blood sampling. The only antiviral prophylaxis given will be acyclovir to prevent~     herpes simplex and varicella zoster reactivation. Subjects with rising PCR exceeding~     threshold for treatment, or those with clinically overt viral disease will receive~     conventional antiviral treatment. Patients developing acute GVHD will receive standard~     treatment with systemic steroids. These patients are eligible for reinfusion of MVST when~     steroids are tapered.~      The clinical trial is designed as a single institution, open label, non-randomized Phase I/II~     trial of MVST in transplant recipients, designed as 3-cohort dose escalation Phase I followed~     by a 20 subject extension Phase II at the maximum tolerated dose of cells. Safety will be~     monitored continuously for a period of 6 weeks post T cell transfer. The primary safety~     endpoint will be the occurrence of dose limiting toxicity, defined as the occurrence of Grade~     IV GVHD or any other SAE that is deemed to be at least probably or definitely related to the~     investigational product. The primary efficacy endpoint for the phase II will be the~     proportion of CMV reactivation requiring treatment at day 100 post transplant. Secondary~     endpoints are technical feasibility of MSVT manufacture, patterns of virus reactivation by~     PCR, and clinical disease from EBV, Ad, BK, day 100 non-relapse mortality.~   "
102029|NCT02231840|"~     Background:~      - About 17 million adults had an alcohol use disorder in 2012. Researchers want to follow~     people that have alcohol problems and want treatment, as well as those who do not want~     treatment and healthy volunteers. They also want to gather information on people with and~     without alcohol problems, including information on genes and biological processes in the~     body.. This will help them better understand, prevent, and treat alcohol problems.~      Objective:~      -To look at a broad range of traits in people who are healthy people and people with alcohol~     problems. To study them for potential eligibility for other research protocols conducted at~     the NIH Clinical Center.~      Eligibility:~        -  Adults age 18 and older.~        -  Not being pregnant or imprisoned.~      Design:~        -  Participants will have a physical exam. They will answer questions about their health~          and alcohol and drug use. They will have an electrocardiogram to check their heart. They~          will have blood, urine, and breath alcohol tests.~        -  Participants without alcohol problems, or who have them but do not want treatment, can~          sign the second consent for screening and research.~        -  Participants that have alcohol problems and want treatment will be treated at the NIH~          Clinical Center. They will be offered to sign the second consent at a later time.~        -  Participants may join an inpatient treatment and detox program. It could last up to 6~          weeks. Or they may join an outpatient program. Some may do both.~        -  After discharge, participants may be called and asked questions about their drinking and~          health.~        -  If participants sign the second consent, they:~        -  will complete paper- and computer-based questionnaires.~        -  will give blood samples.~        -  may have a brain scan using magnetic resonance imaging. They will lie on a table that~          slides in and out of a cylinder that takes pictures. The machine makes loud noises. They~          will get earplugs.~   "
102030|NCT02231827|"~     Gait and balance disorders are important public health problem necessitating studies to try~     to prevent falls. Many studies have dealt with spatiotemporal gait parameters or balance~     during quiet standing (posturography). Nevertheless, falls occurred predominantly during~     gait, and rarely during quiet standing. We have developed a tool to measure balance during~     gait : the braking of the center of mass (CM), a biomechanical parameter obtained from the~     vertical velocity of the CM recorded with a force plate.~      In previous studies, we have shown that the braking of the CM was a physiological and a~     active mechanism, reflecting balance during gait. Unfortunately, the braking of the CM~     measured on a force plate provide an important intra-individual variability.~      The 3D optoelectronic gait analysis system (VICON) also provide an estimation of the CM. The~     primary goal of this study is to compare intra-individual variability of the braking of the~     CM determined by a force plate or the 3D optoelectronic gait analysis system (VICON) in~     healthy subjects.~   "
102031|NCT02231814|"~     This study will evaluate a novel diet for adult crohn's disease patients (The Crohn's Disease~     Exclusion Diet - CDED). Half of the patients in this study will receive the CDED alone while~     the other half will receive the CDED and a liquid diet formula, for 24 weeks.~   "
102033|NCT02231788|"~     The Efficacy of a Fixed Dose Combination of Telmisartan/S-Amlodipine on 24-hour Ambulatory BP~     Control Compared with Telmisartan Monotherapy~   "
102034|NCT02231775|"~     The goal of this clinical research study is to compare receiving the combination of~     dabrafenib and trametinib before surgery to having surgery alone in patients with melanoma.~     The safety of the study drug combination will also be studied.~      This is an investigational study. Dabrafenib and trametinib are both FDA approved and~     commercially available for the treatment of melanoma that is unable to be removed or has~     spread in patients with V600E/K mutations. The use of the drugs in this study is~     investigational.~      Up to 78 participants will be enrolled in this study. All will take part at MD Anderson.~   "
102035|NCT02231762|"~     The purpose of the study is to evaluate the efficacy and tolerability of the combination of~     Lanreotide Autogel 120 mg and Temozolomide in patients with progressive~     gastro-entero-pancreatic neuroendocrine tumours (GEP-NET) graded as G1 or G2 (G1/G2). All~     progressive tumours classified according to Response Evaluation Criteria In Solid Tumours~     (RECIST, 1.1).~   "
102036|NCT02231749|"~     The purpose of this study is to compare the objective response rate, progression free~     survival and the overall survival of Nivolumab combined with Ipilimumab to Sunitinib~     monotherapy in patients with previously untreated Renal Cell Cancer.~   "
102037|NCT02231736|"~     The purpose of the study is to determine whether glycemic control (HbA1c) is linked to~     chromosomal damage in type 2 Diabetes patients~   "
102038|NCT02231723|"~     This is an open label, multi-center, multi-arm, dose-escalation study of BBI608 administered~     in combination with Gemcitabine and nab-Paclitaxel, mFOLFIRINOX, FOLFIRI, or MM-398 with 5-FU~     and leucovorin.~   "
102039|NCT02231710|"~     The purpose of this study is to determine a safe dose of BPX-501 gene modified T cells~     infused after a haplo-identical stem cell transplant to facilitate engraftment and the safety~     of AP1903 on day 7 to prevent GVHD.~   "
102040|NCT02231697|"~     This retrospective medical chart review (RECENSUS) of approximately 100 XLMTM patients (with~     a goal to obtain 50 deceased and 20 living records) will provide further knowledge about the~     clinical manifestations and recorded medical management of XLMTM and potentially inform the~     design of future therapeutic intervention studies.~   "
102041|NCT02231684|"~     This trial is conducted in Europe. The aim of this trial is to investigate the~     pharmacokinetics (the exposure of the trial drug in the body) of subcutaneous injections of~     three different strengths of semaglutide and the absolute bioavailability of semaglutide.~   "
102042|NCT02231671|"~     The purpose of this study is to see how ALS-008176 is taken up, broken down, and removed from~     the body.~   "
102043|NCT02231658|"~     The present study will compare lixisenatide and liraglutide in a population of subjects with~     T2DM not optimally controlled on OADs and / or insulin, which is the target population for~     these medications.~   "
102044|NCT02231645|"~     The purpose of this study is to evaluate whether subthalamic deep brain stimulation (STN DBS)~     can affect moral and economic decisions in patients with Parkinson's disease (PD).~   "
102045|NCT02231632|"~     The purpose of this Phase 2/3 trial is to assess the safety and immunogenicity of Live~     attenuated Poliomyelitis vaccine (human diploid cell)~   "
102046|NCT02231619|"~     The purpose of the study is to design a self-assessment package that could be the preferred~     option to a follow-up visit at the clinic by the majority of women having early medical~     abortion.~   "
102047|NCT02231606|"~     The aim of the project is to create, study and advocate for a model that can be adopted by~     the Chinese government to provide spectacles for all children sustainable.~   "
102048|NCT02231593|"~     The purpose of this pilot study is to test SAGIT (Signs and symptoms - Associated~     comorbidities - GH concentration level - IGF-1 - Tumour). SAGIT is a Clinician-Reported~     Outcomes (ClinROs) tool developed to describe patients with acromegaly. This study will~     determine the potential use of a finalised operational version for patient classification in~     clinical practice and studies.~      In addition, this study intends to carry out a qualitative evaluation of the acceptability of~     SAGIT by the practicing endocrinologist in terms of relevance, ease of use, applicability and~     usefulness of the tool in practice.~   "
102049|NCT02231580|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and~     pharmacodynamics of BN82451B versus placebo after oral administration twice daily (bid) for~     28 days in patients with Huntington's Disease (HD).~   "
102050|NCT02231567|"~     The purpose of the study is to evaluate the effectiveness of an approach based on~     neurocognitive rehabilitation exercises in the form of sensory-motor problems, whose solution~     involves the use of higher cognitive functions (attention, memory, language), not required in~     a traditional approach proprioceptive, in order to obtain a more complete and long-lasting~     recovery.~   "
102051|NCT02231554|"~     The purpose of this study study is to determine whether the Feldenkrais method is effective~     on pain control, functional recovery and quality of life in patients with chronic low back~     pain by comparing it with a Back School program.~   "
102052|NCT02231541|"~     The purpose of the study is to determine the effectiveness of treatment with very low~     frequency electromagnetic fields on the reduction of pain in patients with fibromylgia,~     disease presenting with widespread musculoskeletal pain usually associated with other~     symptoms such as stiffness, fatigue, sleep disturbances, depression, anxiety.~   "
102053|NCT02231528|"~     The GPS system would simplify the technical implementation of central venous catheter under~     ultrasound guidance. We can assume that the introduction of deep venous pathways (as a~     reference, the internal jugular) will be faster, and this, whatever the level of expertise.~     By checking this hypothesis, this technique could be applied to much less frequent situations~     establishment of difficult central venous catheters (hemodynamic status precarious,~     hypovolemia, or cardiac arrest).~      The main objective of this study is to evaluate the time savings provided by the ultrasound~     assisted GPS guidance for installing central venous catheters in the internal jugular.~     Central venous catheters are inserted in the operating room under conditions scheduled in~     advance that is to say outside emergency. The installation time for the central venous~     catheter is compared with that obtained by using the ultrasound machine without the GPS guide~     (conventional technique).~   "
102054|NCT02231515|"~     A prospective, randomized, controlled study to assess efficacy, safety, and tolerability of~     selective laser trabeculoplasty vs. pattern laser trabeculoplasty in patients with open-angle~     glaucoma.~   "
102055|NCT02231502|"~     The purpose of this study is to establish to what extent innovations in food production~     techniques may facilitate retention of bioactive compounds in healthy individuals.~      The study has a single-blinded (outcome assessor), cross-over design; wherein, the plasma~     concentration and urinary excretion levels of a range of bioactive compounds will be assessed~     over a 24 hour period following intake of either a vegetable based convenience food, or a~     minimally processed meal containing the same vegetable materials.~      To do this, 20 healthy volunteers will attend two assessment days (and a follow-up assessment~     at +24hr) and will provide blood and urine samples, which will be collected at biologically~     relevant times over the 24 hour period. In this cross-over study, each meal will be eaten on~     separate days, with a wash-out period of at least 1 week between assessments.~   "
102056|NCT02231489|"~     The purpose of this study is to evaluate the relative bioavailability of JNJ-42756493 oral~     dose of capsule (reference) versus tablet (test) in healthy participants.~   "
102057|NCT02231463|"~     In 50 Patients who are undergoing a planned surgical procedure which require a central venous~     catheter the diameter of the subclavian vein is measured by ultrasound under 6 different~     conditions.~   "
102058|NCT02231450|"~     The purpose of this study is to assess the impact of mild to moderate hepatic impairment on~     the pharmacokinetics of Lu AE58054 following a single oral dose of Lu AE58054~   "
102059|NCT02231437|"~     The aim of this post-marketing surveillance is to obtain further information about the~     tolerability of Berodual® metered-dose inhaler in the treatment of chronic obstructive~     respiratory tract disease under conditions of daily practice~   "
102060|NCT02231424|"~     The aim of this postmarketing surveillance is to obtain further information about the~     tolerability and efficacy of Berodual® metered-dose inhaler in the treatment of chronic~     obstructive respiratory tract disease under conditions of daily practice~   "
102061|NCT02231411|"~     The purpose of this study is to examine whether providing ventilation during delayed~     umbilical cord clamping provides greater placental transfusion and improved hemodynamic~     transition at birth.~   "
102062|NCT02231398|"~     This study is looking at the relationship between experiences during pregnancy and~     cardiovascular health 2 to 3½ years later. The investigators are recruiting women from the~     approximately 10,000 women who were enrolled and followed over the course of their first~     pregnancy in another study.~   "
102063|NCT02231385|"~     The purpose of this study is to compare the additional diagnostic yield obtained by using the~     acetic acid as vital substance to improve the detection of serrated lesions at colonoscopy.~      Patients who are scheduled for screening, surveillance or diagnostic colonoscopy will be~     recruited to the study and randomized to one of two groups. Each enrolled subject will~     undergo two back-to-back procedures limited to the examination of the right colon.~      Subjects in Group A (study group) will undergo a standard colonoscopy. Once the right colon~     has been fully examined, acetic acid 2% will be sprayed and the right colon re-examined from~     cecum to hepatic flexure with within a frame-time of two minutes. Subjects in Group B~     (control group) will undergo a second examination of the right colon without acid acetic and~     within the same frame-time.~      Results from the two groups will be analyzed and compared, with primary outcome measures~     being detection rates for serrated lesions. Secondary outcome measures will include adenoma~     detection rate in the right colon or other locations, characteristics of polyps detected,~     including size and histological results.~      Subjects will be followed through a 24-72 hour telephone interview for analysis of unexpected~     adverse events. Clinical results will be analyzed using various statistical measures of~     significance.~   "
102064|NCT02231372|"~     Tolerability, efficacy and handling of Berodual® Respimat® 20/50µg/dose solution for~     inhalation in patients with chronic obstructive airways disease in daily practice~   "
102065|NCT02231359|"~     Tolerability, efficacy and handling of Berodual® Respimat® 20/50µg/dose solution for~     inhalation in patients with chronic obstructive airways disease in daily practice~   "
102066|NCT02231346|"~     New perceptions about handling and patient satisfaction of the everyday use of Berodual®~     Respimat® compared to a powder inhaler in patients with chronic obstructive lung disease~     (COLD). Moreover, further knowledge should be attained about the tolerability of Berodual®~     Respimat®~   "
102067|NCT02231333|"~     Nonalcoholic fatty liver disease is one the most commonly encountered conditions in a daily~     outpatient Hepatology clinic. Secondly our country is the diabetic capital of the world and~     so the incidence of NAFLD (Non Alcoholic Fatty Liver Disease) is expected to rise in the~     future. It is a spectrum of hepatic pathology, ranging from simple steatosis,~     steatohepatitis, to cirrhosis. Nonalcoholic steatohepatitis (NASH) is a more advanced form of~     disease where steatosis is accompanied by hepatocyte injury as well as infiltration of~     inflammatory cells. Approximately 10-20% of patients with NASH may progress to cirrhosis.~     NASH is felt to be a major etiology of cryptogenic cirrhosis. Around 6230 human studies out~     of which 49 RCTs have been done till date to define the appropriate treatment of nonalcoholic~     steatohepatitis. However, still a controversy and no recommended treatment available till~     date. Recently published PIVENS trial has shown that Vitamin E has proven benefit in NASH.~     Other trials have also shown that pentoxiphylline has shown benefit in the form of~     histological improvement and biochemical improvement in the form of liver enzymes. Role of~     SAMe has been studied in alcoholic liver disease and showed to improve in both biochemical~     and histological features. However the usefulness of SAMe in NAFLD is not known till now.~     Hence this study has been designed.~   "
102068|NCT02231320|"~     New perceptions about handling and patient satisfaction of the everyday use of Berodual®~     Respimat® in patients with chronic obstructive lung disease (COLD). Moreover, further~     knowledge should be attained about the tolerability of Berodual® Respimat®~   "
102069|NCT02231307|"~     The aim of this phase III study is to asses if SUBLIVAC FIX Birch is safe and effective in~     reducing birch allergy induced symptoms and birch allergy medication usage.~   "
102070|NCT02231294|"~     Documentation of the effect of SIFROL® on tremor and depression as well as its tolerability~     in ambulatory patients suffering from idiopathic Parkinson's disease under routine conditions~   "
102071|NCT02231281|"~     The purpose of this study is to assess the ability of the early initiation of cART or cART in~     combination with autologous HIV-1 specific cytotoxic T lymphocyte (CTL) infusion to achieve a~     post-treatment control among treatment-naïve acute HIV-infected adults.~   "
102073|NCT02231255|"~     Documentation of the effect of an direct or overlapping switch from another dopamine agonist~     to Sifrol® on motor function, psychopathological disturbances and mood, assessment of the~     reasons for the switch and the reasons for using Sifrol®, equivalent doses at the end of the~     switch and tolerability of Sifrol® in ambulatory patients suffering from idiopathic~     Parkinson's disease under routine conditions~   "
102074|NCT02231242|"~     The purpose of this study is to determine whether the infusion of intrathecal autologous bone~     marrow total nucleated cells would improve the neurologic evolution of pediatric patients~     with quadriparetic cerebral palsy.~   "
102075|NCT02231229|"~     French guidelines currently recommend to initiate a 4-drug containing regimen associating~     isoniazid (INH or H), rifampicin (RIFor RMP or R), pyrazinamide (PZA or Z) and ethambutol~     (EMB or E) pending the results of drug susceptibility testing (DST). The rationale behind~     routine use of EMB is to prevent the emergence of resistance to rifampicin (RMP), in case of~     primary resistance to INH. Hence, early detection of resistance to INH and RIF using~     molecular testing in Mycobacterium tuberculosis could allow early adaptation of~     antituberculosis treatment: i) start with a 3-drug containing regimen (i.e. INH, RIF, and~     PZA); ii) early enforcement of treatment when resistance is suspected, pending in depth~     susceptibility testings.~      the duration of treatment is 6 months or 12 months.~   "
102076|NCT02231216|"~     Research Question: Performing partial turbinectomy associated with rhinoseptoplasty is~     responsible for an increase in quality of life related to nasal obstruction when compared to~     no intervention in rhinoseptoplasty inferior turbinate?~        -  Population: patients eligible for functional rhinoseptoplasty and / or aesthetic~        -  Intervention: surgery, turbinectomy of inferior turbinates~        -  Comparison: the absence of intervention in inferior turbinates~        -  Primary endpoint: Quality of life related to nasal obstruction~   "
102077|NCT02231203|"~     Ideally, the postoperative inflammatory response is part of a well-orchestrated mechanism~     that contributes to tissue healing and rapid recovery. An exaggerated uncontrolled~     inflammatory response, however may lead to catabolism, tissue damage and organ failure.~     Omega-3 fatty acids may provide a means to alter cellular immune responses to the benefit of~     the patient. When omega-3 fatty acids are incorporated into membranes of inflammatory cells,~     they trigger intracellular signalling pathways that result in a less pro-inflammatory~     response. They modify gene and protein expression, modulate membrane protein activity and act~     as a reservoir for bioactive molecules. They also have a strong anti-inflammatory effect by~     mediating resolution of the inflammation. Furthermore, omega-3 fatty acids improve~     erythrocyte function, which is vital for an adequate microcirculation, tissue oxygenation and~     wound healing.~      The investigators hypothesize that the perioperative administration of intravenous omega-3~     fatty acids results in a rapid incorporation in immune cells and erythrocytes, thereby~     reducing the postoperative inflammatory response and improving erythrocyte function in~     patients undergoing colorectal surgery.~   "
102078|NCT02231190|"~     As per non-clinical studies, prolyl hydroxylase inhibitor GSK1278863 can protect muscle from~     unaccustomed exercise induced muscle damage and enhance functional muscle repair. This study~     is designed to investigate arm function, pain and other pharmacodynamic (PD) markers after~     unaccustomed maximal eccentric exercise with concurrent administration of GSK1278863 or~     placebo. Primary objective of the study is to evaluate the protective effects of GSK1278863~     on eccentric exercise induced muscle injury. Subjects will be randomized in a 1:1 ratio (1~     subject on GSK1278863 for every 1 subject on placebo). Each subject will be given five oral~     doses of GSK1278863/placebo in total. The first dose will be administered immediately after~     completion of eccentric exercise and then 4, 8, 24, and 48 hours later. Subjects will be~     housed till day 4 in unit and will return for a follow-up visit 7-10 days after discharge.~     After enrolment of approximately 30 subjects, enrolment will be paused and planned interim~     analysis will be performed to decide whether to terminate enrolment/study, continue dosing or~     to reduce the dose to 5 milligrams (mg).~   "
102079|NCT02231177|"~     The purpose of this study is to compare the systemic exposure to BI 1744 BS and tiotropium at~     steady state following inhalation of the fixed dose combination (FDC) of 10 μg BI 1744 CL~     plus 5 μg tiotropium bromide with the systemic exposure to BI 1744 BS and tiotropium at~     steady state following inhalation of the single agents, i.e., 10 μg BI 1744 CL and 5 μg~     tiotropium bromide, when administered once-daily via the Respimat® Inhaler for 21 days.~      The secondary objectives were to compare the safety and tolerability (adverse events, 12-lead~     electrocardiogram recordings, pulmonary function testing) of BI 1744 CL and tiotropium~     bromide when administered as fixed dose combination or as single-agent therapy.~   "
102080|NCT02231164|"~     The present trial will investigate the efficacy and safety of nintedanib in combination with~     docetaxel as compared to placebo in combination with docetaxel in patients with stage IIIB/IV~     or recurrent NSCLC of adenocarcinoma histology after failure of first-line platinum-based~     chemotherapy.~   "
102081|NCT02231151|"~     The investigators will look at how accurate pediatric healthcare workers are at judging~     quality of Cardiopulmonary Resuscitation, by observation of the chest compressions, and if~     they are more accurate at a certain position near the patient. The investigators will do this~     by having participants fill out a survey about the quality of the Cardiopulmonary~     Resuscitation in several recorded resuscitation scenarios.~   "
102082|NCT02231138|"~     Huangkui Capsule is a single medicament of traditional Chinese medicine consists of~     Abelmoschus manihot and has been widely used to treat kidney disease. The purpose of this~     study is to evaluate the safety and efficacy of Abelmoschus manihot for treating chronic~     kidney disease in large scale samples with long time take.~   "
102083|NCT02231125|"~     -IgA nephropathy is the most common primary glomerular disease in China, Huangkui Capsule is~     a single medicament of traditional Chinese medicine consists of Abelmoschus manihot and has~     been widely used to treat kidney disease. The purpose of this study is to evaluate the safety~     and efficacy of Abelmoschus manihot for treating IgA nephropathy in large scale samples with~     long time take.~   "
102184|NCT02229799|"~     The objectives of this study are to review the safety and efficacy of Actilyse Vial~     (hereafter referred to as Actilyse) in post-marketing use for treatment of acute ischemic~     stroke, through investigating followings;~        1. Unknown adverse events (especially serious adverse events)~        2. Frequency (Incidence) and trend of adverse events under the actual practice~        3. Factors on the safety profile of Actilyse~        4. Factors on the efficacy profile of Actilyse~   "
102084|NCT02231112|"~     It is well known fact that postoperative whole breast radiation therapy (RT) in left breast~     cancer patient can cause cardiac problem according to the exposed dose. In the several~     studies in other countries, it was repeatedly showed that RT on prone position can reduce~     cardiac exposed RT dose in left breast cancer. However, the effectiveness of prone position~     in RT is not studied in the Korean women have relatively small breast. The investigators~     planned this study to evaluate the real efficacy of prone position in Korean breast cancer~     treated with RT.~   "
102085|NCT02231099|"~     Pelvic organ prolapse is highly prevalent in the female population. The recurrence rate of~     pelvic organ prolapse after surgical treatment is high. This emphasizes the clinical need for~     improvement of the surgical techniques currently used. Placement of a mesh aims at reducing~     the recurrence rate.~      In this study the investigators compare the effectiveness of the Tension free Vaginal mesh +~     Monocryl with standard vaginal prolapse surgery without mesh.~   "
102086|NCT02231086|"~     This study aims to determine the oncological effectiveness of adjuvant HIPEC, using~     intraperitoneal oxaliplatin with concomitant i.v. 5-FU/LV, following a curative resection of~     a T4 or intra-abdominally perforated Colon cancer in preventing the development of peritoneal~     carcinomatosis in addition to the standard adjuvant systemic treatment.~      Hypothesis:~      The hypothesis is that adjuvant HIPEC preceding routine adjuvant systemic therapy using i.p.~     oxaliplatin with concomitant i.v. 5-FU/LV following a curative resection of a T4 or~     intra-abdominally perforated colon cancer reduces the development of peritoneal~     carcinomatosis in comparison to standard adjuvant systemic treatment alone.~   "
102087|NCT02231073|"~     There is emerging research detailing the relationship between balance/gait/falls and~     cognition. Imaging studies also suggest a link between structural and functional changes in~     the frontal lobe (a region commonly associated with cognitive function) and mobility. People~     with Parkinson's disease have important changes in cognitive function that may impact~     rehabilitation efficacy. Our underlying hypothesis is that cognitive function and frontal~     lobe connections with the basal ganglia and brainstem posture/locomotor centers are~     responsible for postural deficits in people with Parkinson's disease and play a role in~     rehabilitation efficacy. The purpose of this study is to 1) determine if people with~     Parkinson's disease can improve mobility and/or cognition after partaking in a cognitively~     challenging mobility exercise program and 2) determine if cognition and brain circuitry~     deficits predict responsiveness to exercise rehabilitation.~      Design: This study is a randomized cross-over controlled intervention to take place at a~     University Balance Disorders Laboratory. The study participants will be people with~     Parkinson's disease who meet inclusion criteria for the study. The intervention will be 6~     weeks of group exercise (case) and 6 weeks of group education (control). The exercise is a~     cognitively challenging program based on the Agility Boot Camp for people with PD. The~     education program is a 6-week program to teach people how to better live with a chronic~     disease. The primary outcome measure is the MiniBESTest and the secondary outcomes are~     measures of mobility, cognition and neural imaging.~      Discussion: The results from this study will further our understanding of the relationship~     between cognition and mobility with a focus on brain circuitry as it relates to~     rehabilitation potential.~   "
102088|NCT02231060|"~     The primary objective of HOPE is to improve the accuracy of outcome prediction in~     anoxic-ischemic encephalopathy following cardiac arrest by bringing under close scrutiny some~     of the existing methods used for this purpose (e.g. somato-sensory evoked potentials). HOPE~     is the first multicenter prospective cohort study on coma prognosis to control for the effect~     of a possible self-fulfilling prophecy at the ICU and to cover the acute and~     neurorehabilitation phases with a long-term follow-up longer than the usual three or six~     months.~   "
102089|NCT02231047|"~     The purpose of this study is to compare the occurrence of childhood diarrheal disease and~     pneumonia in subjects under the age of 5 years in low resource settings who have received~     prophylactic 64N nutraceutical (64N)as a neonate as compared with neonates who have not~     received prophylactic 64N.~   "
102090|NCT02231021|"~     This study evaluate the efficacy and safety of alogliptin and pioglitazone combination~     therapy in comparison with either alogliptin or pioglitazone on glucose control in the~     metformin-treated type 2 diabetic patients in Korea.~   "
102091|NCT02231008|"~     The aim of this study is to investigate tasimelteon vs. placebo on sleep disturbances of~     individuals with Smith-Magenis Syndrome.~   "
102092|NCT02230995|"~     The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose~     combination (FDC) tablet containing empagliflozin and metformin extended release compared to~     the free combination of empagliflozin and metformin extended release under fed conditions.~   "
102093|NCT02230982|"~     To provide early access and to evaluate the safety and tolerability of nintedanib in patients~     with idiopathic pulmonary fibrosis (IPF)~   "
102094|NCT02230969|"~     The primary objectives of the study are to determine the incidence of serious adverse events~     (SAEs) in participants with relapsing forms of multiple sclerosis (MS) in routine clinical~     practice and to assess the overall long-term clinical effectiveness of Plegridy in~     participants with relapsing forms of MS in routine clinical practice. The secondary~     objectives of this study in this study population are to describe Plegridy prescription and~     utilization adherence patterns in routine clinical practice; to assess the specific long-term~     clinical effectiveness of Plegridy in participants with relapsing forms of MS in routine~     clinical practice; to monitor the safety and tolerability of Plegridy in routine clinical~     practice by assessing the incidence of adverse events (AEs) of flu-like symptoms (FLS),~     injection site reactions (ISRs), and AEs (including laboratory abnormalities) leading to~     treatment discontinuation; to assess the effect of FLS on participant-reported effectiveness~     of, and satisfaction with, prophylactic management using a FLS-Visual Analog Scale (FLS-VAS);~     to evaluate the change in health-related quality of life (HRQoL), FLS, FLS-VAS, healthcare~     resource consumption, and treatment adherence over time.~   "
102095|NCT02230956|"~     This study will evaluate the efficacy and safety of a single intra-articular injection of 2~     doses of BOTOX® (onabotulinumtoxinA) compared with placebo as treatment for knee~     osteoarthritis symptoms.~   "
102185|NCT02229786|"~     Study to evaluate efficacy and tolerability of Buscopan® plus versus Buscopan®, paracetamol,~     and placebo in patients with painful gastric or intestinal spasms.~   "
119320|NCT02005731|"~     This is a prospective, pilot study for assessing the safety and efficacy of the treatments~     performed with Renova (LI-ESWT) on symptomatic ED patients.~   "
102096|NCT02230943|"~     The RISE Registry is an enhanced version of the ACR's Rheumatology Clinical Registry (RCR)~     and allows for a simplified entry process, while establishing a best-in-class resource to~     manage your patient population and improve patient care.~      RISE provides participants with an infrastructure for robust quality improvement activities~     leading to improved patient outcomes, patient population management and quality reporting~     related to rheumatic diseases and drug safety. RISE gives physicians and researchers the~     information they need to optimize patient outcomes, meet reporting requirements, and make~     discoveries that advance rheumatology.~   "
102097|NCT02230930|"~     Skin reactions as a result of continuous subcutaneous apomorphine infusion occur frequently~     and interfere with the absorption of apomorphine. The histopathology of apomorphine-induced~     skin reactions is poorly understood. Therefore treatment options are limited and suggestive.~      Objective: to investigate the efficacy of four treatments including massage, dilution of~     apomorphine, treatment with topical hydrocortisone and pre-treatment with subcutaneous~     administered hydrocortisone, in Parkinson's disease patients with apomorphine-induced skin~     reactions.~   "
102098|NCT02230917|"~     Lytic bone disease continues to be one of the most devastating complications of multiple~     myeloma (MM) despite recent and dramatic advancements in MM management, and bone lesions~     persist and can continue to significantly impact a patient's morbidity, even when an~     individual's myeloma is otherwise under good control. To date, no agent has been shown to~     have a prolonged bone anabolic response in myeloma.~      Preliminary studies treating healthy postmenopausal women with a single dose of sotatercept~     demonstrated a rapid and sustained increase in serum biochemical markers of bone formation~     and a decrease in markers of bone resorption. Similarly, the murine analog to sotatercept,~     RAP-011, increases bone mineral density and strength in murine studies of both normal animals~     and models of bone loss. We hypothesize that sotatercept will provide an anabolic response~     for bone in myeloma patients with bone disease.~   "
102099|NCT02230904|"~     The primary objective of the study is to compare the adhesiveness of 2 different patch~     formulations of Rotigotine using the largest patch size of 40 cm^2, under the assumption that~     both patch formulations show similar adhesiveness properties.~   "
102100|NCT02230891|"~     Despite advances in cardiovascular care, the occurrence of heart failure (HF) is steadily~     increasing. The increase in HF rates poses enormous challenges, as once an individual becomes~     symptomatic or requires hospitalization with HF, the prognosis remains poor. Therefore,~     prevention of HF is essential. HF prevention is a critical issue as HF risk factors that~     include common medical conditions such as hypertension and diabetes are also increasing.~     However, not everyone with these risk factors develops HF. Using novel blood tests, the~     investigators propose to identify and treat subjects at higher HF risk to see if the~     investigators can stabilize or improve ultrasound measures known to be associated with HF~     risk. This study will enroll only Veterans.~   "
102101|NCT02230878|"~     The purpose of this study is to investigate the safety, tolerability, pharmacokinetic (the~     study of the way a drug enters and leaves the blood and tissues over time),~     dose-proportionality, accumulation, urinary excretion, pharmacodynamics (the study of how~     drugs act on the body) and sedative effects of JNJ-42847922 in healthy male and female~     participants.~   "
102102|NCT02230865|"~     Pain is an expected part of surgical recovery but effective pain management remains~     challenging. The high variability in postoperative pain experience and analgesic treatment~     response between patients is part of the challenge. Few studies have yet combined~     preoperative assessment of responses to experimental pain with measurements of cognitive and~     emotional processes in the prediction of postoperative pain.~      We hypothesize, that preoperative evoked brain potentials (using standard~     electroencephalographic brain imaging), endogenous pain inhibition capacity (conditioned pain~     modulation), responses to pressure/thermal pain stimulation, and/or situational pain-related~     catastrophic thinking are useful clinical predictors of postoperative pain and analgesic~     consumption.~   "
102103|NCT02230852|"~     The PreSSUB trial I will focus on prehospital telemedicine for patients with suspicion of~     acute stroke. The study is designed as a prospective monocentric observational trial on the~     safety, feasibility and reliability of in-ambulance telemedicine for patients with suspicion~     of acute stroke during transportation by the Paramedic Intervention Team of the Universitair~     Ziekenhuis Brussel.~   "
102104|NCT02230839|"~     The purpose of this study is to provide information regarding potential factors underlying~     metabolic dysfunction, insulin resistance, and loss of muscle mass in aging muscle.~   "
102105|NCT02230826|"~     This long-term outcomes study is designed to collect safety and efficacy data on designated,~     commercially available, Tornier hip arthroplasty products.~   "
102106|NCT02230813|"~     The term cellulitis is a medical term describing a bacterial infection of the skin and~     tissues beneath the skin. Although it is usually easily treated with antibiotics given either~     orally or through a vein (intravenously), knowing which route of antibiotic treatment to~     prescribe to a person attending an Emergency Department with cellulitis is not clear.~      A Clinical Prediction rule (CPR) is a decision-making tool that comes from original research~     as opposed to the opinion of experts. We intend to create a preliminary CPR to decide which~     patients require oral and which patients require intravenous antibiotics for cellulitis from~     their first visit to an emergency department. The aim of this is to provide safer care by~     reducing the risk of a patient returning to the hospital with a worsening infection. It will~     also promote more cost-effective care by reducing hospital re-attendance rates and wasted~     antibiotics.~      Patients attending the department with cellulitis who are suitable for oral antibiotic~     treatment will be enrolled into this study. A separate doctor will re-examine at least 10% of~     study participants in order to reduce bias. A set of physical signs and symptoms will be~     recorded from each patient in order to determine which ones are associated with them~     failing prescribed oral treatment. A study investigator will then phone the patient after~     14 days to see whether they are better or whether they required intravenous antibiotics to~     get better.~   "
102186|NCT02229773|"~     Lipid lowering effect, investigation of pharmacodynamics (inhibition of oxidosqualene~     cyclase, monoepoxysqualene (MES) as marker), safety / tolerability and preliminary~     pharmacokinetics~   "
102187|NCT02229760|"~     To determine the effect of steady-state tipranavir 500 mg/ritonavir 200 mg (TPV/r) on~     intracellular concentrations of zidovudine triphosphate (ZDV-TP) and carbovir triphosphate~     (CBV-TP) and plasma viral load~   "
102107|NCT02230800|"~     Side effects are common after treatment with radiotherapy for tumours in the pelvis and can~     affect the way the bowel and urinary system work as well as causing sexual difficulties, skin~     damage and bone problems. Problems in the bowel, bladder, sexual organs and skin mostly~     result from thickening of the tissues in response to radiotherapy, a process called~     fibrosis. Fibrosis often worsens over time.~      There has been progress in treating bowel symptoms which usually are the worst problem after~     radiotherapy. However, even after receiving the best possible treatments, while many patients~     are better, they are often not cured of all their difficult problems.~      For some years, it has been hypothesised that if fibrosis could be treated then symptoms~     would improve. Recent research in laboratory animals has suggested that an effective~     treatment for radiation-induced fibrosis is combination therapy with a drug called~     Pentoxifylline together with a nutritional supplement containing gamma-tocotrienol (Tocovid~     SupraBio), a substance derived from palm oil. Both of these agents are simple to take and~     side effects are rare.~      This study will recruit volunteers who continue to have difficult side effects after previous~     radiotherapy to the pelvis despite receiving the best treatments available from a unique~     clinic at The Royal Marsden which has pioneered treatment for bowel problems after~     radiotherapy. Two out of every three volunteers who take part, will be randomly assigned to~     treatment with Pentoxifylline and Tocovid SupraBio, while one out of three will receive dummy~     pills. Neither the patients nor the staff assessing them will know which treatment they have~     been given. Volunteers take the active treatments or dummy tablets for a year and will be~     assessed regularly while on treatment and for a year afterwards. This study will show whether~     active treatment is more effective than dummy pills in improving the symptoms caused by~     radiation-induced fibrosis.~   "
102108|NCT02230787|"~     Enamel matrix proteins have been shown to play a crucial role during tooth development and~     its supporting tissues. This is used in periodontal surgery where regeneration of lost~     tissues around the teeth is intended. Emdogain, a product of Straumann Institute contains~     these matrix proteins and has been successfully used in regenerative periodontal surgery for~     more than 16 years.~      The treatment of gum recession is a common requirement, more and more patients are seeking~     treatment at the investigators' clinic due to aesthetic concern, root sensitivity and~     difficulties in performing adequate oral hygiene. The standard treatment comprises the~     transplantation of a piece of connective tissue from the palate to the denuded root surface.~     In many cases Emdogain is additionally applied to enhance healing. So far the effect of~     Emdogain on the early wound healing process after surgical root coverage has not been~     investigated.~      The purpose of the investigators' study is to compare early wound healing parameters between~     treatment with and without Emdogain. For this study 40 patients undergoing root coverage~     surgery at the investigators' department will be included. Early wound healing features~     between the two groups will be described and compared. Furthermore, inflammatory markers~     typical for early healing will be evaluated together with patients`subjective postoperative~     comfort. Finally, outcomes 6 months after the treatment will be assessed. The investigators'~     hypothesis is that Emdogain treatment enhances wound healing and decreases post-operative~     complication rates.~   "
102109|NCT02230774|"~     The main purpose of this study is to assess and compare the hydration status of medical and~     nursing staff and to investigate the relationship between the hydration status, cognitive~     function and serum cortisol (marker of stress).~      We hypothesise that a significant proportion of doctors and nurses will be dehydrated at the~     end of their working day. Some, as in other occupations, may be dehydrated at the start of~     their working day. This is likely to be associated with impairment in cognitive performance~     at the end of the working day compared to the beginning and expected to be more pronounced~     after a night shift. There may be less noticeable difference amongst nursing staff given the~     protected break time. Dehydration and associated impairment in cognition is of important~     clinical value as it can impact patient care. participants will be involved in the study for~     two shifts (one day and one night), aiming at 15 medical and 15 surgical nurses as well as 15~     medical (total 15 day and 15 night shifts from each group) and surgical doctors (total 15 day~     and 15 night shifts from each group). Those that do not work both day and night shifts will~     participate for only one shift and a new participant will be recruited until target number of~     shifts is achieved.~   "
102110|NCT02230761|"~     This study will test whether XAF5 (XOPH5) ointment, applied once daily to the lower eyelids~     for 10 weeks, reduces the prominence of lower eyelid fat in adults with moderate to severe~     steatoblepharon (excess eyelid fat).~   "
102111|NCT02230748|"~     -  Evaluation of safety and effectiveness of implantable LAA occluder in clinical practice~        -  Indication: For which reasons is the indication for implantation of LAA-Occluder put for~          patients with atrial fibrillation?~        -  Safety: How save is the implantation of LAA-Occluders?~        -  Effectiveness: How effective is implantation of LAA-Occluders in daily clinical~          practice?~        -  Concomitant treatment: Which concomitant treatment is prescribed for patients with~          LAA-Occluder?~   "
102112|NCT02230735|"~     Will patients that receive injections of Marcaine into the uterine nerve via the uterosacral~     ligaments experience less pain postoperatively, need less narcotic pain medication and return~     to activities of daily living sooner.~   "
102113|NCT02230722|"~     The investigators propose to develop a novel intervention that targets the system~     (Collaborative Care), PCP (computerized decision support for opioid therapy) and veteran~     (CM-delivered MI) to reduce problematic prescription opioid use and encourage non-opioid pain~     management alternatives.~   "
102114|NCT02230709|"~     The aim of this study is to determinate the effects of percutaneous electrical nerve~     stimulation in the short-term for pain in patients with myofascial chronic neck pain.~   "
102115|NCT02230696|"~     To compare safety and efficacy of Perrigo's steroid drug product compared with an FDA~     approved steroid drug product in the treatment of subjects with seasonal allergic rhinitis.~   "
102116|NCT02230683|"~     This is an open-label pilot study to evaluate the safety, tolerability, and efficacy of~     IDN-6556 in treating portal hypertension in subjects with liver cirrhosis.~   "
102117|NCT02230670|"~     This is a multicenter study to see if treatment with IDN-6556 can help improve the liver~     function of patients with liver cirrhosis with Model for End-Stage Liver Disease scores~     between 11-18.~   "
102118|NCT02230657|"~     The purpose of this study is to identify differences in satisfaction, pain and length of stay~     between patients undergoing hip replacement who are discharged from the hospital on the day~     of surgery compared to patients who stay one night in the hospital.~   "
102129|NCT02230514|"~     The present study evaluates the effect of XCEL-MT-OSTEO-ALPHA in non-union fractures~     (pseudoarthrosis) of long bones in comparison to the standard treatment of autologous iliac~     crest.~      XCEL-MT-OSTEO-ALPHA is a tissue engineering product composed by ex-vivo expanded autologous~     mesenchymal stromal cells fixed in allogenic bone tissue, produced by Xcelia (Blood and~     Tissue Bank of Catalonia).~      The working hypothesis proposes that the tissue engineering is a valid and useful technique~     to achieve bone regeneration up to consolidation of non-union fractures.~   "
102119|NCT02230644|"~     Over 4.6 million operations are undertaken each year in England alone. Of these, many~     patients experience psychological distress, which has negative implications for patient~     recovery. Indeed, psychological stress, in particular both trait and state anxiety, anger and~     distress, has been linked with slower wound healing (Broadbent et al., 2003) and more~     complicated post-operative recovery (Johnston and Wallace, 1990).~      However, pre-operative psychological interventions can have significant positive effects on~     components of of post-operative recovery (Navros et al., 2011; Weinman and Johnston, 1988).~     In particular, music has been studied in a series of randomised control trials as a way of~     reducing pre-surgical stress. Studies have shown the effects of music in reducing levels of~     stress hormones such as cortisol (Leardi et al., 2007) and reducing both heart rate and blood~     pressure, and have also found music to be more effective than benzodiazepine at reducing~     pre-surgical anxiety (Bringman et al., 2009).~      Chelsea and Westminster Hospital NHS Foundation Trust is a major surgical hospital,~     performing over 15,000 adult operations annually. Consequently, strategies to reduce patient~     anxiety and improve experience are amongst the hospital's priorities. A renovation of the~     Surgical Admissions Lounge is currently underway with plans to incorporate visual arts and~     music in waiting booths to relax and distract patients. When asked how relaxing they found~     the space, patients at Chelsea and Westminster Hospital involved in a public consultation~     rated the current unenhanced waiting area as 5.8/10, but 93% of patients said that relaxing~     music would help them feel less anxious. This project will test whether music and art in the~     SAL actively reduce adult patient stress compared to normal unenhanced waiting spaces, with a~     view to extending the arts interventions to other surgical waiting areas such as the day~     treatment centre if there are significant positive findings.~   "
102120|NCT02230631|"~     This survey is conducted in South America. The aim of this survey is to investigate~     hypoglycaemia among Insulin-treated patients with diabetes.~   "
102121|NCT02230618|"~     This study is conducted in Asia. The aim of this study is to evaluate long term safety and~     efficacy in patients with diabetes mellitus in routine clinical practice in India.~   "
102122|NCT02230605|"~     Many individuals experience an acute change in thinking and reasoning skills after surgery.~     This is called post-operative delirium (PD). PD symptoms typically start 1-3 days after~     surgery. Advanced age has been identified as a risk factor for PD. The purpose of this study~     is to determine if performing mental exercise, before surgery, will help reduce post-surgery~     memory and thinking problems. A total of 268 patients will be recruited for this study.~      At least 10 days before surgery, subjects complete a series of questionnaires to assess~     baseline cognition level (or thinking ability) and status of overall well-being. At the~     completion of the screening visit, qualifying subjects are randomized into two groups:~      Participants randomized into the Cognitive Exercise group are expected to complete~     tablet-based brain games provided by Lumosity. These subjects are given a handheld tablet for~     the duration of the preoperative period. Participants in this group are expected to achieve 1~     hour of mental training each day for at least 10 consecutive days prior to surgery.~      Participants randomized into the Normal Activity group are encouraged to carry out their~     baseline daily activities, and do not have any study-related cognitive exercise expectations~     before surgery. These subjects still complete the same questionnaires and assessments as the~     Cognitive Exercise group throughout the study, however, are asked not to alter their normal~     daily routine of mental exertion (i.e. watching television, reading, puzzles, etc.) and are~     not permitted to subscribe to Lumosity while in the research study.~      On the day of surgery, a baseline delirium evaluation (CAM - Confusion Assessment Method) is~     taken before surgery. During surgery, research personnel monitor vital signs and medications~     given. After surgery, another CAM evaluation is taken in the post-operative recovery room.~      Throughout the subject's hospital stay, pain levels and medication usage are recorded. The~     CAM and MDAS (Memorial Delirium Assessment Scale) are used to identify and determine severity~     of PD. The evaluations are given twice daily, at approximately 6:00 AM and 6:00 PM, for 7~     days or until hospital discharge (whichever comes first). The Postoperative Quality of~     Recovery Scale (PQRS) is used each post-operative day at 6:00 PM until discharge, and~     completed over the phone on POD 7 if patient discharged. The PQRS is also administered over~     the phone on POD 30 and POD 90.~   "
102123|NCT02230592|"~     Objective:~      Metabotropic glutamate receptors (mGluRs) are G-protein coupled receptors that respond to~     glutamate by activating proteins inside nerve cells that affect cell metabolism, thereby~     fine-tuning the signals sent between cells to maintain balance in neuronal activity. mGluR~     subtype 1 (mGluR1s) are located in several brain regions, including the cerebellum,~     hippocampus, olfactory bulb, and basal ganglia. mGluR1 activation stimulates phospholipase C,~     resulting in phosphoinositide hydrolysis and increased intracellular calcium levels.~     Successful development of a positron emission tomography (PET) ligand to image mGlurR1 would~     impact clinical management of brain disorders characterized by disruptions in glutamatergic~     transmission, including anxiety and stress disorders, drug addiction, epilepsy, Huntington s~     disease, and Parkinson s disease. However, detailed study of mGluR1s has heretofore been~     hindered by the lack of high affinity and selective ligands for this receptor subtype.~      The present protocol will evaluate the ability of a new PET ligand, [18F]FIMX, to image and~     quantify mGluR1 in the brain of healthy human volunteers. This protocol covers four phases:~        1. Phase 0: screening whole-body scan;~        2. Phase 1: kinetic brain imaging to quantify mGluR1 in brain relative to concurrent~          measurement of the parent radioligand in arterial plasma;~        3. Phase 2: if the tracer is successful in Phase 1, we will estimate radiation-absorbed~          doses of [18F]FIMX by performing whole body imaging;~        4. Phase 3: test-retest analysis of brain binding relative to concurrent measurement of the~          parent radioligand in arterial plasma.~      Study Population:~      Healthy adult female and male volunteers (n=22, ages 18 to 55) will undergo brain or~     whole-body imaging..~      Design:~      This study will begin with a screening whole-body scan to confirm that the radioactivity has~     fairly broad distribution in several organs. For absolute quantification of mGluR1, 22~     healthy controls will have brain PET imaging using [18F]FIMX and an arterial line. Up to 12~     of them will have a test-retest scan. Eight additional subjects will have a whole body PET~     scan for dosimetry, which does not require an arterial line.~      <TAB>~      Outcome Measures~      To assess absolute quantitation of mGluR1 with [18F]FIMX, we will primarily use two outcome~     measures: the identifiability and time stability of distribution volume calculated with~     compartmental modeling. In test-retest study, we will calculate the retest variability. To~     assess whole-body biodistribution and dosimetry of [18F]FIMX we will use the organ~     time-activity curves....~   "
102124|NCT02230579|"~     This is a first-in-human study of MMV390048. The study will evaluate the safety, tolerability~     and pharmacokinetic properties of escalating single and multiple doses of MMV390048 when~     administered to healthy male volunteers and female volunteers of non-childbearing potential.~      In addition, the effect of food on the pharmacokinetics and tolerability of MMV390048 will be~     investigated.~   "
102125|NCT02230566|"~     The Phase 3 study will use a novel randomized, intra-subject placebo-controlled, single~     crossover design, referred to as Blind Start, to evaluate the safety and efficacy of UX003.~     The Blind Start is a novel design whereby participants will be randomized to 1 of 4 groups,~     each representing a different treatment sequence, and will cross over to UX003 at different~     pre-defined time points in a blinded manner. All groups will receive a minimum of 24 weeks~     treatment with 4 mg/kg UX003 every other week (QOW).~   "
102126|NCT02230553|"~     This is an open-label phase I/II multi-center study consisting of two parts. Part A of this~     study is designed to identify the recommended phase 2 dose (RP2D) of lapatinib combined with~     trametinib in patients with metastatic KRASm and PIK3CA wild-type (PIK3CAwt) non-small cell~     lung cancer (NSCLC). Part B is designed to perform a randomized comparison of the~     lapatinib-trametinib combination versus standard of care therapy in patients with metastatic~     KRASm/PIK3CAwt NSCLC.~   "
102127|NCT02230540|"~     The aim of this investigation is to study how the position of different catheters affect~     drainage of the bladder.~   "
102128|NCT02230527|"~     This is a single center, prospective, randomized, unblinded, open-label, active controlled~     pilot study to evaluate the efficacy and safety of ticagrelor plus aspirin versus clopidogrel~     plus aspirin in patients with Rutherford Stage IV to VI PAD that have undergone a~     percutaneous transluminal angioplasty (PTA) of the lower extremities in the past 2 weeks.~   "
102297|NCT02228330|"~     The aim of this study is to estimate the incidence rate of obturator nerve reflex and leg~     jerking during Transurethral Resections of Bladder Tumors (TURBTs), evaluate the efficacy of~     obturator nerve block in the prevention of inadvertent muscle spasm, and to identify~     predictors for both the jerking reflex and successful nerve block.~   "
102130|NCT02230501|"~     Formerly, the investigators demonstrated in an uncontrolled proof-of principle study (NCT~     01680926) that protein-rich meal replacement (PRMR) was successful in reducing daily insulin~     demand, HbA1c and weight in type 2 diabetes mellitus (T2DM) patients injecting >100 IE~     insulin/day. The aim of the present study was to investigate in a randomized-controlled trial~     if PRMR is also effective in T2DM patients treated with oral antidiabetic medication or~     insulin.~      A second part of the study is an open-label registry for persons with type 2 diabetes, who~     will perform the lifestyle intervention with the stringent diet regime.~   "
102131|NCT02230488|"~     The purpose of this study is to assess whether intensive case management interventions by a~     diabetes team, led by an endocrinologist and certified diabetes educator, can prevent <31 day~     readmission in previously identified high risk patients with diabetes.The procedures of the~     study will focus on managing the patient's diabetes and diabetes education while in the~     hospital, decreasing the patient's risk for hypoglycemia and hyperglycemia in the hospital,~     and assist in the patient's diabetes management plan for a safe discharge.~   "
102132|NCT02230475|"~     This clinical study will use the Environmental Exposure Unit (EEU) to generate allergic~     rhinitis symptoms in participants under controlled conditions, to collect well-characterized~     biological samples (urine and blood) before and after they develop these symptoms. The EEU~     provides the ability to control the timing, duration and levels of allergen exposure, and~     also other outside environmental factors, yielding ideal biologic samples for analysis with~     novel, cutting-edge molecular techniques. Results from the analysis of these unique allergic~     rhinitis samples should help determine if the technique of urine Nuclear Magnetic Resonance~     analysis could be a useful diagnostic tool in allergic rhinitis. IgE testing will be done on~     blood samples and compared to spin prick testing and symptoms of allergic rhinitis.~   "
102133|NCT02230462|"~     The purpose of this study is to assess the effects of visualization of skin cancer resection~     defects on the face on the post-operative satisfaction of patients after their~     reconstruction. To achieve this aim, patients invited to participate in this study will be~     randomized to either seeing or not seeing their skin cancer excision defect prior to~     reconstruction. After reconstruction, patient satisfaction will be assessed in both groups to~     determine if visualization of the defect prior to reconstruction has any effect on patient~     satisfaction and if any detected effect has durability over time.~   "
102134|NCT02230449|"~     The aim of the study is to analyze the expression of genes and microRNAs potentially involved~     in oocyte competence in follicles of different sizes (<17mm and ≥17mm) at the time of oocyte~     pick-up.~   "
102135|NCT02230436|"~     The aim of this study is to demonstrate the hypothesis that early removal of drain can reduce~     the incidence of intra-abdominal infection and pancreatic fistula after pancreatectomy~     compared with later removal of drain.~   "
102136|NCT02230423|"~     This study investigates wether patients with increased trigeminal perception threshold and~     low expression of TRP channels have more often nasal blockage despite functionally successful~     nasal surgery (TRP channel = transient receptor potential channel).~   "
102137|NCT02230410|"~     To assess the response of persistent Barrett's Esophagus and/or dysplasia to focal cyro~     ablation .~   "
102138|NCT02230397|"~     Aim of the study was to evaluate clinically and by non-invasive instrumental evaluations the~     revitalizing activity of a face cream applied twice a day, morning and evening, for an~     uninterrupted period of 8 weeks, by healthy female volunteers aged 45-55 years with face~     ritidosis and women aged 55-65 years not habitual user of antiage-creams.~      The study foresaw the comparison within subjects of the study product versus placebo (half~     face method).~      It was also aim of this study to evaluate products efficacy and cosmetic acceptability by the~     volunteers and tolerance both by investigator and volunteers.~   "
102139|NCT02230384|"~     The investigators will evaluate effects of a novel drug that improves nicotinergic receptor~     function vs. placebo on short-term smoking abstinence in smokers with schizophrenia who have~     a high interest in quitting. The investigators predict that the novel drug will increase days~     of abstinence, compared with placebo, identifying potential evidence of efficacy for smoking~     cessation in smokers with schizophrenia.~      The investigators will also assess if this new drug decreases nicotine withdrawal, craving,~     and cognitive impairment during early abstinence, as well as evaluate adverse effects.~   "
102140|NCT02230371|"~     The aim of this study is to to investigate if local treatment with intramuscular injections~     of granisetron are effective in alleviating pain in patients with chronic myofascial pain in~     the orofacial muscles~      The study hypothesis is that local administration of granisetron reduces pain and~     allodynia/hyperalgesia in patients with chronic myofascial pain in the orofacial muscles and~     that this effect of granisetron on pain is larger than the effect from placebo~   "
102141|NCT02230358|"~     The aim of this study is to investigate the differences between the cardiac output and the~     cerebral blood-flow between a regional anesthesia (RA) and a general anesthesia (GA) in a~     randomized, controlled, single center study at the Medical University Innsbruck, Department~     of Anesthesia and Intensive Care Medicine.~   "
102142|NCT02230345|"~     The important role played by the GI tract microflora on the metabolic health of an individual~     are increasingly recognized. In this respect, the initial studies of Metchinkoff that~     suggested a role of fermented food (specifically yoghourts ) to modulate the gut microflora~     have evolved into the concept of probiotics. Probiotics are living microorganisms that~     bring a benefit to the host when administered in sufficient quantity (WHO/FAO, 2001).~      Here the investigators will study, in normal young male volunteers, the potential to modulate~     post-prandial metabolic and inflammatory responses by the administration of a yoghourt~     containing the probiotic Lactobacillus rhamnosus (LGG).~   "
102167|NCT02230020|"~     Preliminary data show that in COPD patients, HFT substantially decreases ventilatory demand~     during sleep. The central hypothesis of this proposal is that lowering ventilatory demand~     using nasal high-flow therapy during sleep will elevate lung function, reduce dyspnea on~     exertion and improve quality of life. Thus, this proposal aims will determine the effects HFT~     over time on 1) lung function; 2) dyspnea on exertion; and 3) quality of life.~   "
102309|NCT02228174|"~     The objective of this study is to establish the safety and effectiveness of the Sonata®~     System in the treatment of symptomatic uterine fibroids.~   "
102310|NCT02228161|"~     This study will investigate if yoga exercises decrease work-related stress and improve stress~     adaptation in professional health helpers.~   "
102143|NCT02230332|"~     Beta-2-agonists are effective in reducing airway narrowing in asthma and protecting against~     stimuli that produce bronchoconstriction. The combination of long-acting beta agonists (LABA)~     and inhaled corticosteroids (ICS) has become the most commonly used asthma controller~     medication class in the United States, but unfortunately, even when LABAs are added to ICS~     and used regularly, 58-81% of patients with asthma fail to achieve total control. Regular use~     of beta-agonists, both short and long-acting, reduces the ability of these agents to protect~     against the airway narrowing that occurs in asthma in response to bronchoconstrictor stimuli.~     We refer to this reduced effect as loss of bronchoprotection. In this proof of concept trial~     we aim to determine if alendronate, which diminishes beta-2 adrenergic receptor~     internalization, can reduce the loss of bronchoprotection that occurs with regular use of~     LABAs, even when used in combination with ICS.~   "
102144|NCT02230319|"~     The purpose of this study is to determine if cryotherapy can effectively decrease the rate of~     neuropathy in patients undergoing weekly paclitaxel treatments.~   "
102145|NCT02230306|"~     The purpose of this study is to evaluate the effectiveness of the combination of vemurafenib~     with cobimetinib in patients with active melanoma brain metastases.~   "
102146|NCT02230293|"~     The purpose of this study is to determine if multidisciplinary care improves the health~     condition of hypertensives.~   "
102147|NCT02230280|"~     Most stroke survivors live with other chronic health conditions that can negatively affect~     their recovery and overall health and well-being. Although stroke care has improved, there~     are still many challenges to the delivery of community-based stroke care. These challenges~     include: poor coordination of care across health care providers and settings; limited~     communication among health care providers; limited use of evidence-based treatment~     guidelines; difficulties navigating community services and supports; and limited client and~     family caregiver involvement in making healthcare decisions. The investigators developed a~     new mobile health (mHealth) application, My Stroke Team (MYST), to address these challenges~     to improve the overall quality of stroke care at home. This study will expand this work to:~     1) explore the feasibility and acceptability of this mobile tool, 2) determine its impact and~     usability for home care providers, stroke survivors, and their family caregivers, and 3)~     determine its impact on the costs of use of health services.~   "
102148|NCT02230267|"~     Several animal and human epidemiologic studies have provided evidence that exercise may be~     neuroprotective in Parkinson's disease (PD). Exercise may forestall diagnosis and, in the~     case of those who have already been diagnosed with PD, it may slow the observed~     neurodegeneration. Unfortunately, because this line of research is in early stages, there is~     little evidence to indicate what biological mechanisms underlie the neuroprotection that is~     conferred with exercise. Toward this end, it is possible that an interaction between~     endogenous antioxidant enzymes, inflammatory processes, and reactive oxygen species may be~     associated with exercise improvements in PD.~      One of the most common reasons for premature death in PD is falls. Several meta-analyses have~     concluded that exercise training programs focused on balance and/or strength training are~     effective at improving aspects of balance. Taken together, the current body of evidence~     suggests that exercise may be neuroprotective and balance/strength training may decrease the~     likelihood of a fall. The combination of these efficacious treatment modalities (exercise and~     balance/strength training) in a comprehensive treatment approach to improve PD symptoms and~     balance has been previously reported at relatively mild or moderate exercise intensities.~     Because recent research has suggested that patients with PD may benefit more from more~     physically intense programs, we are proposing a more aggressive approach with regard to~     exercise intensity and frequency in the present trial. The primary purpose of this study is~     to determine the feasibility and safety of a high intensity exercise approach to PD. A~     secondary purpose is to determine the trajectory of change in outcomes over the duration of~     the trial from a high intensity fall prevention program. It is hoped that a signal of~     efficacy will allow this trial to progress to a comparative effectiveness trial. An important~     innovative design element is collecting biological assays to better understand the mechanism~     underlying the anticipated clinical improvements.~      Aim 1 is to test the feasibility of a high-intensity exercise and fall prevention boot camp~     (HIBC) in patients with PD by analyzing adherence and whether they achieve minimum Centers~     for Disease Control exercise standards (150 min/wk moderate level aerobic exercise;~     strengthening at least two times per week) for the duration of the trial. Aim 2 is to~     determine if participation in an 8-week HIBC under the direction of a physical therapist is~     safe for individuals with PD. Secondary Aim 3 is to determine if participation in an 8-week~     HIBC will produce a signal of efficacy for several physical outcomes: falls per physical~     activity ratio, balance efficacy, motor activity, fatigue, muscle strength, bone health,~     cognition/mood, and quality of life. Secondary Aim 4 is to determine if participation in an~     8-week HIBC will produce a signal of efficacy for biological outcomes, anti-inflammatory~     cytokines and anti-oxidant enzymes. An additional exploratory aim will be an analysis of BDNF~     val66val, val66met, met66met polymorphisms to determine if there is a differential response~     to exercise.~      This trial is innovative because it utilizes a high intensity comprehensive exercise~     treatment approach (aerobic exercise, strengthening, and balance training). To our knowledge,~     there have been no trials of individuals with PD who have participated in a trial of this~     intensity in a group boot camp setting. Another innovative design element is the use of~     three novel assessments: biological assays of pro- and anti-inflammatory cytokines,~     endogenous anti-oxidant enzymes and a novel assessment of falls (falls per physical activity~     ratio).~      Participants will be randomly assigned into either an 8-week HIBC group or an 8-week usual~     care control group (standard, low intensity group therapy class) under the direction of~     physical therapists. Each group will have 15 participants with a 1:5 patient-to-therapist~     ratio. The HIBC will be 1.5 hours daily, Monday through Friday. Participants will be required~     to attend 3 out of the 5 days. The protocol of the HIBC will include the following exercise~     components: A. 30 minutes of moderate-high intensity aerobic exercise; B. 15 minutes of~     strengthening the major muscle groups; C. 15 minutes of balance training; and, D. 15 minutes~     of interspersed rest and stretching. Participants will rotate through these four exercise~     components. Participants will have one baseline test and assessments at the 2-week, 4 week,~     8-week, and 6-month points. Outcomes of the primary aims (Aim 1 and Aim 2) will be frequency~     counts of participation, adverse events, and compliance with exercise. The outcomes for the~     secondary aims will include measures of balance and falls, physical capacity, fatigue,~     exercise/physical activity behavior, and biological assays.~   "
102149|NCT02230254|"~     PE PREMIER China: A Prospective, Multicenter Trial to Assess the Promus PREMIERTM~     Everolimus-Eluting Platinum Chromium Coronary Stent System for the Treatment of~     Atherosclerotic Lesion(s)~   "
102150|NCT02230241|"~     This is a multi-center survey of patients who are currently receiving lipid-lowering~     medications and have a moderate or higher cardiovascular (CV) risk. The survey will be~     conducted in the Russian Federation. Data collection for each study subject will be done~     within one physician visit. If an enrolled subject comes to the visit not fasting (for at~     least 8 hours), an appointment for the blood tests will be made for another day.~   "
102151|NCT02230228|"~     This protocol is a phase 1 clinical study to assess the safety and pharmacokinetics of~     ALK-001 in healthy volunteers. Please contact trials@alkeus.com for any questions.~   "
102152|NCT02230215|"~     This study will use a special type of x-ray called radiostereometric analysis (RSA) imaging~     to determine whether patient-specific instrumentation for total knee arthroplasty~     (replacement) has an effect on implant loosening compared to conventional instrumentation.~     Secondary objectives will include assessment of post-operative implant alignment, patient~     satisfaction, operative time and surgical instrument use, cost, and environmental impact.~   "
102153|NCT02230202|"~     The primary hypothesis of this proposal is that chronic kidney disease (CKD) and treatment~     with calcineurin inhibitors (CNIs) are each associated with the release of endothelial~     microparticles into the plasma.~   "
102154|NCT02230189|"~     This protocol describes a single site mechanistic study to investigate microRNAs (miRNAs)~     that are differentially expressed in the airway epithelium of patients with asthma at~     baseline and in response to allergen challenge. We hypothesize that allergen exposure~     enhances airway smooth muscle contractility and epithelial cell mRNA/miRNA production as a~     consequence of locally increased T-cell derived cytokine production. The study will involve~     three visits over the course of approximately 14 days. At Visit 1, participants will be~     characterized in detail with lung function testing, methacholine challenge testing, and~     allergen skin prick testing. At Visit 2, participants will undergo bronchoscopy with~     segmental allergen administration of either cat or dust mite standardized allergen extract.~     At Visit 3 (either 24 hours later or 7 days later), bronchoscopy will be performed to collect~     airway samples including bronchoalveolar lavage (BAL), epithelial brushings and endobronchial~     biopsies. Sample analysis will include measurement of miRNA and mRNA expression in epithelial~     brushings (RNAseq and qPCR); analysis of cell surface markers on BAL cells and blood cells;~     and collection of endobronchial biopsies for immunostaining of immune cells localization,~     immunoblotting of smooth cell protein phosphorylation, analysis of mucin content and smooth~     muscle cell subculture. A total of 38 subjects (26 asthmatics with stable or well-controlled~     asthma, 6 allergic non-asthmatics and 6 non-allergic non-asthmatics) will complete the study.~   "
102155|NCT02230176|"~     This study is the first randomized, open-label, national, multicenter, phase II study~     assessing the efficacy and safety of OCLU in subjects with pretreated progressive pancreatic,~     inoperable, somatostatin receptor positive, well differentiated pancreatic neuroendocrine~     tumors (WDpNET). Subjects must have experienced documented progression of disease within 1~     year prior to the start of the study. The control group of patients receiving Sutent will be~     used as internal control to assess the hypothesis of 12 months PFS equal to 35% in patients~     receiving Sutent.~   "
102181|NCT02229838|"~     Safety, pharmacodynamics and pharmacokinetics of 0.25, 0.75, 2.0, 6.0, and 10 mg BIBB 1464~     p.o once daily in a rising dose group-comparison (placebo controlled, double blind,~     randomized per dose level).~      Relative Bioavailability of 0.75 mg or 2 mg or 6 mg ( tablet vs. solution, intraindividual~     comparison), preliminary assessment of food effects (interindividual comparison)~      Two-stage Trial Design With Randomised Double Blind Placebo Controlled Rising Dose Phase and~     Subsequent Randomised, Open Parallel Group Phase).~      MS (Tablet) in Healthy Male Subjects, Combined With Preliminary Evaluation of Relative~     Bioavailability and Effect of Food of the Dose of 0.75 mg or 2 mg or 6 mg (Two-stage Trial~     Design With Randomised Double Blind Placebo Controlled Rising Dose Phase and Subsequent~     Randomised, Open Parallel Group Phase).~   "
102156|NCT02230163|"~     Chikungunya virus (CHIKV) has been detected in humans in the Caribbean area for the first~     time in November 2013 (St-Martin Island). By February 2014, the virus had spread to several~     other Caribbean islands as well as French Guyana, South America. During the outbreak of~     Chikungunya that affected the Reunion island in 2005/2006, it was observed that the neonatal~     forms of infections acquired by mother to child transmission during childbirth, were not the~     exception and were critical. Mother-to-child transmission occurs when the mother is viremic~     at the time of delivery. The mean duration of viremia after the onset of first clinical~     symptoms is six days. The rate of mother-to-child transmission is 50%. All neonates~     contaminated during labor and delivery present with a symptomatic disease and the rate of~     severe forms is about 50%, primarily due to damage of the central nervous system, often~     leaving permanent damage (seizures, cerebral palsy).Due to the severity of Chikungunya in~     neonates and the burden of cerebral palsy, it is imperative to identify a safe and effective~     preventive and/or curative intervention. Human polyvalent immunoglobulins purified from~     plasma samples obtained from Chikungunya-convalescent donors exhibit a potent neutralizing~     activity in vitro. They were evaluated for their preventive and curative effects in a~     neonatal mouse model of CHIKV infection. After administration of a lethal dose of CHIKV, all~     neonatal mice that had received immunoglobulins survived while all control animals that had~     received non hyperimmune immunoglobulins died. In humans, specific human immunoglobulins~     proved to be effective and safe in neonates born to hepatitis B viremic mothers.~      Hypothesis : The investigators hypothesize that the administration of anti-CHIKV hyperimmune~     human intravenous immunoglobulins to neonates exposed to a high risk of severe form of~     Chikungunya infection is safe enough to justify its evaluation in an open non randomized~     trial aimed to confirm the safety and preliminary assess the efficacy of this intervention.~   "
102157|NCT02230150|"~     The purpose of this study is to verify the impact of the educational intervention in the~     adhesion to therapeutic strategies for patients with heart failure.~   "
102158|NCT02230137|"~     The purpose of this study is to assess HbA1c reduction after supportive care by SMS among~     adolescents with poorly controlled type 1 diabetes.~   "
102159|NCT02230124|"~     The purpose of this project is to assess the utility of a new magnetic resonance technique~     called magnetic resonance elastography (MRE) in the non-invasive diagnosis of normal pressure~     hydrocephalus. The investigators hypothesize that MRE produces a unique imaging signature for~     hydrocephalus that distinguishes the disease from the normal (non-hydrocephalic) but~     atrophied brain, a distinction not possible with conventional MR imaging studies that are~     presently available.~   "
102160|NCT02230111|"~     The purpose of this study is to measure the effects of a reduced-calorie low energy density~     diet with and without increased cognitive dietary restraint (CDR) on stress (biological~     markers and perceived stress), eating behaviours, appetite sensations, anthropometric~     variables and women's attitude toward their children's eating behaviours in premenopausal~     overweight/obese women in both the short term (immediately after the end of the 4-week~     intervention) and longer term (3 months after the end of the intervention). The investigators~     hypothesize that cortisol concentrations are higher, appetite sensations are increased (i.e.~     increased global appetite score) and food cravings are more prevalent in women of the~     energy-restriction-plus-CDR group than in women of the energy-restriction-without-CDR group~     after the 4-week intervention. They also hypothesize that perceived stress is higher and food~     cravings are more prevalent in women of the energy-restriction-plus-CDR group than in women~     of the energy-restriction-without-CDR group at 3-month post intervention. They hypothesize~     that no significant difference in body weight changes is observed between the two groups and~     that maternal restriction of their child's eating is higher in the~     energy-restriction-plus-CDR group than in the energy-restriction-without-CDR group both after~     the 4-week intervention and at the 3-month follow-up.~   "
102161|NCT02230098|"~     Cardiovascular disease is the second leading cause of death in Denmark, and ischemic heart~     disease accounts for the bulk of it. The purpose of this study is to clarify whether a~     mechanical method of remote ischemic conditioning in the form of short-term obstruction of~     the blood supply to the arm, can improve the heart's blood supply in patients with ischemic~     heart disease. This will be attempted through experiments on patients with ischemic heart~     disease and experimental animal studies with simulated cardiovascular disease.~      This study will help to clarify whether remote ischemic preconditioning can be used to treat~     patients with ischemic heart disease.~   "
102162|NCT02230085|"~     While continuous positive airway pressure (CPAP) is the gold standard treatment of~     obstructive sleep apnea (OSA), this therapy is often discontinued or not used optimally. The~     adherence risk indicator (ARI) is a statistical model based on answers from a questionnaire.~     The data collected from this trail allows for closer monitoring of at-risk patients. For the~     study, participants are provided with a questionnaire prior to starting CPAP therapy for OSA.~     Participants will be provided with a GSM (Global System for Mobile communication) modem to~     allow transmission of their CPAP data. Participants data will be retrieved at 7, 14, 21, 30~     and 90 days to test the accuracy of the ARI prediction. At the conclusion of the study the~     GSM unit is returned, and participants continue with CPAP therapy as instructed by their~     healthcare provider.~   "
102163|NCT02230072|"~     The purpose of the study is to evaluate the maternal and fetal outcomes of a new technique~     for the fetoscopic repair of fetal MMC at Texas Children's Hospital Pavilion for Women.~      The investigators hypothesis is that this minimally invasive technique is feasible, and that~     this approach will have the same efficacy as open fetal surgery for MMC, but with~     significantly less maternal-fetal risk. Both mother and baby will benefit from the surgery.~     The fetus will have a repaired MMC defect, and the mother will not have a uterine incision~     (hysterotomy). A hysterotomy increases the risk of uterine rupture and requires that all~     subsequent deliveries are by cesarean section. There may also be a decreased risk of Pre-term~     Premature Rupture Of Membranes (PPROM) and prematurity when compared with the current open~     operation. Finally, a vaginal delivery is possible following the fetoscopic fetal surgery if~     the baby is shown to have a skin covered repair.~   "
102164|NCT02230059|"~     The purpose of this study is to assess the treatment patterns in participants with metastatic~     castration-resistant prostate cancer (mCRPC). Additionally, participant's demographic and~     clinical characteristics, skeletal-related events, criteria used to define CRPC, prostate~     specific antigen (PSA) levels and pain related to disease and overall survival will be~     observed.~   "
102165|NCT02230046|"~     The purpose of this study is to determine the bioequivalence (equivalence of pharmacokinetic~     parameters) of 2 abiraterone acetate coated tablet formulations with respect to the current~     commercial abiraterone acetate uncoated tablet formulation under fasted (without eating or~     drinking) conditions in healthy male participants.~   "
102166|NCT02230033|"~     The purpose of this study is to assess the effect of multiple doses of itraconazole or~     gemfibrozil on the pharmacokinetics (the study of the way a drug enters and leaves the blood~     and tissues over time) of JNJ-56021927 and its metabolites (JNJ 56142060 and JNJ-56142021) in~     healthy male participants.~   "
102168|NCT02230007|"~     The MEOPA is used to obtain an analgesia of the short-term painful acts. To the population of~     elderly patients, the therapeutic resources to control the passing pain require in their~     manipulation a certain caution and are not divested of side effects badly tolerated at this~     age. An alternative in the opioid presents all its interest. The MEOPA is here an alternative~     of choice in the care of these pains, in particular in case of pre-existent cognitive~     achievement, of polypathologies or of polymédication.~      The gas MEOPA administered to the mask could thus be an effective additive in the~     physiotherapy treatment of the elderly person.~      The main objective is to Assess the efficacy , in terms of recovery of the hip and knee joint~     articular amplitude, of 3 sessions of reeducation using MEOPA versus standard reeducation~     within a population of elderly patients presenting a pain during the physiotherapy treatment.~   "
102169|NCT02229994|"~     The purpose of this study is the psychometric validation of a self-administered dyspnea~     questionnaire, usable in clinical practice in order to assess dyspnea and its impact on~     patients with chronic respiratory diseases.~   "
102170|NCT02229981|"~     This is a sequential Phase I and IIa study to identify the maximum tolerated dose and to~     evaluate safety, tolerability, toxicity, pharmacokinetics and pharmacodynamics of the oral~     sphingosine kinase inhibitor ABC294640 specifically in patients with diffuse large B-cell~     lymphoma (DLBCL), including virus-associated (e.g., KSHV- or EBV-associated) DLBCL or Kaposi~     Sarcoma (KS) after failure of or intolerance to initial standard therapy.~   "
102171|NCT02229968|"~     The purpose of this study is to determine whether Amicar (ε-aminocaproic acid) is effective~     in reducing blood loss in children undergoing craniofacial reconstruction surgery.~      The investigators hypothesize that Amicar will decrease intraoperative blood loss and~     decrease the need for perioperative blood product administration in children undergoing~     craniofacial surgery.~   "
102172|NCT02229955|"~     The purpose of this clinical Study is Tisporin Eye Drops 0.05%(Cyclosporine ophthalmic~     solution) group and Restasis Eye Drops 0.05%(Cyclosporine ophthalmic suspension) group 12~     weeks after treatment, each treatment group comparisons for evaluation of efficacy and safety~     in Moderate to Severe Dry Eye Disease.~      - Corneal staining test, Ocular surface disease index (OSDI), Tear break up time (TBUT),~     Non-anesthetic Schirmer test~   "
102173|NCT02229942|"~     The hypothesis is that a subgroup of patients with Chronic Fatigue Syndrome/ Myalgic~     Encephalopathy (CFS/ME) have a chronically activated immune system and may benefit from~     B-lymphocyte treatment using the monoclonal anti-CD20 antibody rituximab with induction and~     maintenance treatment.~   "
102174|NCT02229929|"~     The primary purpose of this study is to:~        -  Evaluate the safety and pharmacokinetic profile of repeated doses IV CR845 over one week~          in patients who are undergoing hemodialysis. (Part A)~        -  This study is also investigating whether repeated doses of IV CR845 over two weeks is~          safe and effective in reducing the intensity of itching in hemodialysis patients with~          uremic pruritus (Part B).~   "
102175|NCT02229916|"~     The majority of testicular cancer patients can be cured with cisplatin-based chemotherapy.~     Mortality has been reduced even more within the last 15 years due to the stringent~     application of standard chemotherapy followed by resection of residual disease. This is a~     positive development considering that testicular cancer usually affects young men. Active~     surveillance has become an acceptable and widely used strategy in stage I testicular cancer.~     Thus, it is important to follow these patients in a standardized way and to adhere to a~     rationale surveillance strategy. There is no international consensus regarding follow-up of~     testicular cancer patients. Stratification according to risks and patterns of relapse would~     allow to tailor follow-up schedules, aiming at early identification of relapse without~     causing unnecessary harm by using excessive radiation in these young long-term survivors.~     Follow-up procedures should not only aim at detecting relapse, but also long-term side~     effects from therapy, including hypogonadism, metabolic syndrome, cardiovascular disease and~     secondary malignancies. The Swiss Austrian German Testicular Cancer Cohort Study (SAG TCCS)~     will comprise consecutive newly diagnosed testicular cancer patients and is the first study~     to prospectively evaluate the initial indictor of relapse in testicular cancer patients, the~     frequency and pattern of relapse and document long-term toxicities of the treatment~     (cardiovascular, gonadal, hearing impairment, renal function and second malignancies) and~     psychosocial aspects. This cohort study will determine the relevance of each test performed~     routinely during follow-up. The collected data will have direct implications for the care of~     patients with testicular cancer and inform future adaptations of follow-up recommendations.~     The dataset will give information on baseline factors of testicular cancer patients patients,~     current treatment strategies in Switzerland, Austria and Germany, outcome and late sequelae.~   "
102176|NCT02229903|"~     The purpose of the study is to evaluate the safety and efficacy of the Deep TMS (DTMS)~     treatment in subjects with OCD. The device technology is based on the application of deep~     brain TMS by means of repetitive pulse trains at a predetermined frequency. The Brainsway~     DTMS study is a randomized, 10 week, double blind, multi-center trial comparing active DTMS~     treatment to sham treatment.~   "
102177|NCT02229890|"~     Study to evaluate the safety and efficacy of intravenous recombinant tissue Plasminogen~     Activator, alteplase, Actilyse® (rt-PA) (0.9 mg/kg) within 3 hours of symptom onset in acute~     ischemic stroke~   "
102178|NCT02229877|"~     The purpose of this study is to: determine the effect of stomach pH on the multiple dose~     pharmacokinetics (PK) of gefapixant (AF-219); assess the effect of multiple doses of~     gefapixant on various sensory assessments; and, assess the safety and tolerability of~     gefapixant.~   "
102179|NCT02229864|"~     The ABSORB III PK sub-study is a prospective, open-label, non-blinded study enrolling~     approximately 12 subjects in up to 5 US sites. ABSORB III PK sub-study is a part of ABSORB~     III RCT (NCT01751906). The objective is to determine the pharmacokinetics of everolimus~     delivered by the Absorb BVS in a separate and non-randomized cohort of subjects who only~     receive Absorb BVS with a maximum of two de novo native coronary artery lesions after~     implantation of the Absorb BVS.~      Note: The ABSORB III PK subjects will not contribute to the determination of the ABSORB III~     RCT primary endpoint.~   "
102180|NCT02229851|"~     This study is conducted globally. The purpose is to demonstrate the efficacy of once weekly~     dosing of NNC0195-0092 compared to placebo and once-daily dosing of somatropin (human growth~     hormone, hGH) after 35 weeks of treatment in adults with growth hormone deficiency.~   "
102182|NCT02229825|"~     Study to assess efficacy of Duloxetine 120 mg and Duloxetine 60 mg in patients hospitalized~     for severe depression after 4 weeks of treatment. To evaluate the rescue option in~     non-responding patients. Safety of Duloxetine will also be assessed.~   "
102183|NCT02229812|"~     Study to evaluate the safety and efficacy of intravenous alteplase within 3 hours of symptom~     onset in acute ischemic stroke patients~   "
103968|NCT02206503|"~     This study evaluates the efficacy of the addiction of Cyclophosphamide to Revlimid-low dose~     dexamethasone (Rd) in relapsed/refractory Multiple Myeloma patients, who experienced a~     biochemical progression, without CRAB, during Rd treatment.~   "
102188|NCT02229747|"~     The objective of this study was to assess the clinical efficacy and safety of meloxicam~     suspension 0.25 mg/kg/day once a day, versus diclofenac suspension 1 mg/kg/day twice a day or~     nimesulide suspension 4 mg/kg/day twice a day, after five days of treatment in patients with~     a diagnosis of acute, non-bacterial pharyngitis, pharyngotonsillitis or laryngitis~   "
102189|NCT02229734|"~     This study will explore the combination of a stereotactic body radiation therapy (SBRT)~     approach combined with one year of luteinizing hormone releasing hormone (LHRH) agonist for~     older men with high risk prostate cancer, or men unwilling to undertake conventionally~     fractionated therapy and three years of adjuvant hormone therapy.~      The purpose of this study is to examine the safety of a shorter course of radiation treatment~     combined wtih androgen deprivation therapy.~   "
102190|NCT02229721|"~     The purpose of this study is to determine whether intranasal oxytocin is effective in~     comparison to placebo in improving female sexual dysfunction in pre- and postmenopausal~     women.~   "
102191|NCT02229708|"~     The purpose of this study is to find out whether a technology-base healthy lifestyle program~     is an acceptable and effective way for African-American mothers to improve their eating and~     activity during pregnancy, compared to usual obstetric care. The goal of the program is to~     enhance the health of African-American mothers and their babies.~   "
102192|NCT02229695|"~     This is a prospective comparison trial. Patients that will be included in the trial are those~     that will have operations in which their abdominal closure is temporary, i.e. patients~     sustaining trauma or septic abdomen.~      Patients will be grouped according to the method of temporarily abdominal closure (TAC)~     procedure:~        1. Vacuum-assisted closure (VAC)~        2. Bogota bag (BB), a sterile intravenous bag silo closure. The two methods are currently~          accepted with no clear cut evidence to prefer one on another. At Soroka Medical Center~          the decision to choose either of the methods is at the surgeon's discretion.~      Intra-abdominal pressure will be measured in all patients by the urinary bladder pressure~     technique at 6 12 24 ant 48 hours post operation. The measurement is a routine procedure done~     as part of the monitoring processes of critically ill patients in the General Intensive Care~     Unit (GICU).~      Patients will be evaluated for the development of acute intra abdominal hypertension with or~     without abdominal compartment syndrome.~   "
102193|NCT02229682|"~     This study is to make sure whether reduced-dose radiation treatment is sufficient to control~     the disease in patients with early-staged extranodal nasal-type NK/T-cell lymphoma, who have~     got complete remission tumor after chemotherapy in a new and more effective~     asparaginase-based GELOX regimen~   "
102194|NCT02229669|"~     This study compared the clinical outcomes of coronally advanced flap using two different~     surgical strategies in the treatment of multiple gingival recessions.~   "
102195|NCT02229656|"~     Accelerated, normofractionated radiotherapy is the treatment of choice in stage II-III~     laryngeal and oropharyngeal squamous cell carcinoma (SCC). However, twenty to thirty percent~     of patients with stage II-III laryngeal and HPV negative oropharyngeal SCC develop disease~     progression, mainly due to lack of locoregional control. Radiosensitizers such as cisplatin~     and cetuximab are added to radiotherapy in more advanced stage of head and neck (H&N) cancer.~     These radiosensitizers improve loco-regional control and overall survival. Unfortunately, as~     these radiosensitizers, notably cisplatin, also dose intensify the radiation dose in normal~     tissues, they also significantly increase toxicity. Adding a more tumor-specific~     radiosensitizing agent could improve loco-regional control and overall survival without~     significantly increasing toxicity.~      Radiotherapy kills tumor cells by inducing DNA damage. The efficacy of radiotherapy is~     limited by the ability of tumor cells to repair this DNA damage. Poly(ADP-ribose)polymerase~     (PARP) is an essential enzyme in base excision repair and single strand break DNA repair, DNA~     lesions arising from radiation treatment. PARP inhibition and consequently the inhibition of~     PARP-facilitated DNA repair enhances the anti-tumor activity of radiotherapy, as shown in~     preclinical studies including head and neck xenograft studies. This radiosensitization is~     thought to be proliferation dependent and is more pronounced in homologous recombination (HR)~     deficient cells, providing an opportunity for tumor specific targeting. Genetic analyses~     suggest that HR deficiency is commonly found in H&N SCC: ATM loss has been reported in 60% of~     human H&N SCC biopsies and FANC-F defects were reported in 15-21% of human H&N SCC biopsies~     and cell lines.~      The efficacy of radiotherapy is also limited by tumor hypoxia, as tumor hypoxia results in~     radioresistance. Some PARP inhibiting compounds increase tumor perfusion in xenograft models,~     thereby reducing hypoxia and specifically sensitizing tumor cells to radiotherapy. Hypoxia is~     commonly found in H&N SCC and a high pre-treatment hypoxic fraction in H&N SCC tumors is~     associated with worse outcome. The high prevalence of both hypoxia and HR deficiencies in H&N~     SCC support the concept of tumor-specific radiosensitization by PARP inhibition in head and~     neck cancer patients.~      Olaparib is a potent PARP inhibitor developed as an anti-cancer drug for HR defected tumors~     and as a dose intensifier for chemo- and radiotherapy. In humans, olaparib has a low toxicity~     profile as a single agent, with increasing bone marrow toxicity when combined with~     chemotherapy. The combination of olaparib and radiotherapy for H&N SCC is expected to improve~     locoregional control and thereby overall survival. However, this combination treatment has~     never been tested in humans before. The purpose of this study is to determine the safety and~     tolerability of radiotherapy for stage II-III laryngeal and stage II-III HPV-negative~     oropharyngeal SCC with concurrent olaparib.~   "
102196|NCT02229643|"~     Neuroglobin has been described as a marker of traumatic brain injury. Nogo-A plays an~     important role in mediating neuroanatomical plasticity and functional recovery following~     traumatic brain injury. The investigators sought to examine the changes in serum neuroglobin~     and Nogo-A concentrations in patients with traumatic brain injury during the initial 96-h~     posttraumatic period and assessed the relation of neuroglobin and Nogo-A to Glasgow Coma~     Score and prognosis of such patients with traumatic brain injury.~   "
102197|NCT02229630|"~     The purpose of this study is to compare the apparent diffusion coefficient in the frontal~     lobe of foetuses with intra-uterine growth restriction and poor neonatal outcome compared~     with foetuses with intra-uterine growth restriction and a good neonatal outcome.~   "
102198|NCT02229617|"~     For people who identify as transgender, there is a strong sense that they were born into the~     wrong body and that their outward looking body does not match how they truly feel about~     themselves. They feel male, not female and have always felt that way. There is a great deal~     of discomfort or dysphoria about looking and feeling female, and there is a strong desire to~     achieve a more masculine appearance. While surgery, clothing and hair for example, can help a~     person appear more like a male, many transgender males will want to take testosterone to make~     them feel and look more masculine.~      This usually involves injecting testosterone into a muscle every 1-2 weeks for many years.~     Intramuscular injections can often be uncomfortable or painful, and requires the patient to~     be taught how to inject themselves. Or somebody else has to do it. There is a growing trend~     in some transgender men to give their injection just below the skin or subcutaneously (like~     insulin in a diabetic), because it is less uncomfortable but we don't really know if~     testosterone gets into the blood in the same way. At least one clinic in the US already~     suggests that patients can use the subcutaneous method but there is almost no research to~     show it's the same as intramuscular.~      Our project will be looking at a small group of transgender males who are already on~     intramuscular testosterone and then switch them over to the same dose of subcutaneous~     testosterone, and then compare their levels of testosterone. If those levels are similar,~     then patients may chose the less uncomfortable subcutaneous injection.~   "
102199|NCT02229604|"~     Diminished ovarian reserve (DOR)is a disease can not be cured. Medicine for DOR includes~     dehydroepiandrosterone (DHEA), hormone replacement therapy (HRT), immunosuppressive agents~     and alternative therapy, etc. Electroacupuncture (EA) can help patients regain regular~     menses, increase the estradiol (E2) level and decrease the follicle-stimulating hormone (FSH)~     and decrease FSH/luteotropic (LH) ratio. In this cohort study, we aim to observe the effect~     of EA versus other therapies for DOR.~   "
102200|NCT02229591|"~     Expiratory flow limitation (EFL) occurs when flow ceases to increase with increasing~     expiratory effort. In any circumstances EFL predisposes to pulmonary dynamic hyperinflation~     and its unfavorable effects such as increased elastic work of breathing, inspiratory muscles~     dysfunction, and progressive neuroventilatory dissociation, leading to reduced exercise~     tolerance, marked breathlessness during effort, and severe chronic dyspnea. Our hypothesis is~     that EFL should affect post operative outcomes like incidence of pulmonary complication and~     length of stay in hospital~   "
102201|NCT02229578|"~     Burn pain is known to be one the most severe forms of acute pain often requiring large~     amounts of narcotics in addition to other adjuvants. Topical lidocaine is effective for~     controlling pain in various settings including dressing changes of burns. The aim of this~     study is to demonstrate the effectiveness of topical lidocaine in decreasing pain scores and~     narcotic requirements when applied to donor graft sites while at the same time not~     interfering with the standard of care TheraBond dressing. During this study the investiagtors~     will be monitoring for evidence of delayed wound healing, and surgical site infection.~   "
102202|NCT02229565|"~     The purpose of this study is to further elucidate the molecular mechanisms underlying~     prostate cancer disparities. In previous work the investigators have identified a set of~     differentially deregulated genes in African American versus Caucasian American prostate~     cancer. Based on these findings, they hypothesize that they will be able to validate these~     targets, originally identified in the previous work conducted at The George Washington~     University Medical Center, in an independent Duke University Medical Center cohort of~     prostate cancer specimens. In addition, the investigators hypothesize that they will be able~     to discover novel targets in the Duke University Medical Center cohort of prostate cancer~     specimens because of regional differences.~   "
102203|NCT02229552|"~     The study is designed to assess habituation of behavioral responding for food as risk factors~     for increases in Standardized Body Mass Index (zBMI) over three years in non-overweight~     children.~   "
102204|NCT02229539|"~     The purpose of this study is to test whether a mouthwash made with a drug called doxepin can~     reduce the pain caused by mouth sores resulting from radiation therapy. A number of mouth~     rinse preparations exist for patients with treatment-related oral mucositis pain such as the~     DLA rinse, an over-the-counter medication. This study will evaluate the effects of doxepin~     compared to DLA (diphenhydramine, lidocaine and antacids) and placebo.Doxepin is approved by~     the Food and Drug Administration (FDA) for the treatment of depression, anxiety, long-term~     pain management, as well as management of rash.~   "
102205|NCT02229526|"~     The initial trial examined if fish oil supplementation during pregnancy could reduce the risk~     of pregnancy induced hypertension, intrauterine growth retardation, and preterm birth in~     pregnancies that were at increased risk of these complications. The study was designed as a~     multi-centre clinical trial based in 19 hospitals in seven countries in Europe.~   "
102206|NCT02229513|"~     The objective of the study is to demonstrate whether cooling the uterine smooth muscle during~     cesarean section (following delivery of the fetus) will promote better uterine contraction~     and involution resulting in lower blood loss, use of fewer uterotonic medications, and fewer~     hysterectomies following cesarean section. The investigators suspect that it may.~   "
102207|NCT02229500|"~     Obesity, with its associated co-morbidities, is a major public health challenge. It is~     estimated that by 2050, 60% of men and 50% of women will be clinically obese. Obesity is~     associated with increased risk of developing diabetes, cardiovascular disease, and certain~     cancers. The increasing epidemic of obesity has necessitated the study of the complex~     mechanisms underlying energy homeostasis. Food intake, energy balance and body weight are~     tightly regulated by the hypothalamus, brainstem and reward circuits, on the basis both of~     cognitive inputs and of diverse humoral and neuronal signals of nutritional status. Several~     gut hormones, including glucagon-like peptide-1 (GLP-1) and peptide YY3-36 (PYY), have been~     shown to play an important role in regulating short-term food intake. Peripheral~     administration of PYY or GLP-1 enhances satiety and reduces food intake in animals and man.~     PYY, GLP-1 along with a host of other hormones are produced by the gut in response to~     nutrient availability in different regions of the gut and provide an exquisite mechanism of~     nutrient sensing in response to dietary intake. These hormones therefore represent potential~     targets in the development of novel anti-obesity treatments. A novel and attractive strategy~     to induce appetite regulation is the enrichment of foods with components that stimulate the~     release of GLP-1 and PYY. The short chain fatty acids (SCFA) produced by microbial~     fermentation of dietary fibre in the colon have been shown to stimulate the release of PYY~     and GLP-1 from rodent enteroendocrine L cells, via stimulation of the G-protein coupled free~     fatty acid receptors (FFAR) on colonic L cells. Of the SCFAs produced by colonic fermentation~     of dietary fibre, propionate has the highest affinity for FFAR 2. Furthermore, propionate is~     an end product of bacterial metabolism, and thus, unlike acetate, does not undergo conversion~     to other SCFAs. Increasing colonic propionate is therefore an attractive target for appetite~     modulation.~      We have developed a novel delivery system for delivering propionate to the right site in the~     colon and we now wish to optimise the delivery of propionate to the colon in man using stable~     isotope labelling methods.~   "
102208|NCT02229487|"~     Hypothesis~        1. Prediabetes patients who have insufficient sleep will have worse glucose tolerance than~          those with normal sleep duration.~        2. Prediabetes patients with short sleep will have a delayed or reduced GLP-1 response to a~          standardized meal~   "
102209|NCT02229474|"~     This trials of cognitive stimulation therapy (CST) in Tanzania is part of the larger~     Identification and Intervention for Dementia in Elderly Africans (IDEA) study.~      The overall aim of the IDEA study is to set up and evaluate sustainable programmes to~     facilitate diagnosis of, and therapy for, people with dementia led by local communities in~     sub-Saharan Africa. We aim seek to improve quality of life for people with dementia and their~     caregivers.~      Within this trial of CST, we hypothesise that CST can significantly improve the quality of~     people with dementia and their carers living in Africa~   "
102210|NCT02229461|"~     To determine if administration of naproxen sodium 220 mg maintains the platelet inhibitory~     effect of a low dose Immediate Release Aspirin (IR ASA) regimen.~   "
102386|NCT02227173|"~     This is an open-label, single-sequence, drug-drug interaction study in healthy male and~     female subjects. There is no formal research hypothesis to be statistically tested. It is~     expected that coadministration of BMS-986020 with montelukast, flurbiprofen, and digoxin may~     increase the exposure of montelukast, flurbiprofen, and digoxin.~   "
102211|NCT02229448|"~     Immunoglobulin G4-related disease (IgG4-RD) is an increasingly recognized syndrome of unknown~     etiology comprised of a collection of disorders that share specific pathologic, serologic,~     and clinical features.~      Histopathological analysis of biopsy specimens remains the cornerstone in the diagnosis of~     IgG4- related disease. Elevated concentrations of IgG4 in tissue and serum are helpful in~     diagnosing IgG4-related disease, but neither one is a specific diagnostic marker. Correlation~     with specific histopathological findings is essential, regardless of the serum IgG4~     concentration, the number of IgG4-positive plasma cells in tissue, or the ratio of IgG4 to~     IgG in tissue. Misdiagnoses of IgG4-related disease are increasingly common because of~     excessive emphasis on moderate elevations of serum IgG4 concentration and overreliance on the~     finding of IgG4-positive plasma cells in tissue.~   "
102212|NCT02229435|"~     Statement:~      Patients with Chronic kidney disease (CKD) with an estimated glomerular filtration rate~     (eGFR) under 60 ml/min using the MDRD-6 (Modification of Diet in Renal Disease) formula~     and/or CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula should undergo~     nephrological and urological care (diagnosis and treatment) to prevent chronic kidney~     failure. This is recommended by the National Kidney Foundation Kidney Disease Outcomes~     Quality Initiative (KDOQI), Kidney Disease Improving Global Outcomes (KDIGO) and European~     Urological Association (EAU). Renal and postrenal diseases can cause or worsen CKD.~     Internistic and intrarenal diseases can caused or worsen CKD. All diseases affecting CKD~     should be treated and the medical care should be optimized.~      Hypothesis:~      Not all patients with CKD receive urological and nephrological care. Interdisciplinary work~     of outpatient working urologists and nephrologists in the metropolitan area Magdeburg /~     Saxony-Anhalt Germany is unknown. An descriptive analysis of interdisciplinary treatment~     connection of CKD patients for an orientating statement is needed.~   "
102213|NCT02229422|"~     We hypothesize that GA101 - Obinutuzumab in combination with HDMP is well tolerated and will~     induce similar if not higher response rates than the ones observed in Rituximab plus HDMP~     studies (Castro et al., 2009, Castro et al., 2008).~   "
102214|NCT02229409|"~     This study evaluates the product Walkadoo to determine whether it effectively increases~     walking behavior in healthy adults.~   "
102215|NCT02229396|"~     Study D5553C0003 is a 28-week, randomized, double-blind, active-controlled, multicenter,~     Phase 3 efficacy and safety study with 24-week and 52-week extension phases of simultaneous~     administration of exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg once daily (QD)~     compared to EQW 2 mg alone and dapagliflozin 10 mg QD alone in patients with Type 2 diabetes~     who have inadequate glycemic control on metformin.~   "
102216|NCT02229383|"~     Study D5553C00002 is a multicenter, randomized, double-blind, placebo-controlled, parallel~     group, Phase 3 study to compare the safety and efficacy of exenatide once weekly (EQW) added~     to titrated basal insulin glargine with or without metformin to placebo added to titrated~     basal insulin glargine with or without metformin in patients with type 2 diabetes mellitus~     (T2DM). Eligible patients will be randomized at Visit 5 (Day 1) to receive either EQW added~     to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, or placebo added~     to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, during the~     28-week treatment period.~   "
102217|NCT02229370|"~     To prospectively collect data on ECAA we designed the Carotid Aneurysm Registry (CAR). The~     aim of this study is to collect data on ECAA and its treatment to assess the natural history~     of ECAA and the success and safety of different treatment strategies.~   "
102218|NCT02229357|"~     This study aim to compare immunogenicity of the inactivated H5 influenza vaccine single dose~     between subjects previously vaccinated with LAIV H5N2 and naïve subjects~   "
102219|NCT02229344|"~     The purpose of this study is to describe clinical course of newly diagnosed moderate to~     severe ulcerative colitis (chronic inflammatory disease of the colon) in tertiary referral~     hospitals in Korea for 5-year follow-up under usual care.~   "
102220|NCT02229331|"~     Haemophilia is a rare X chromosome-linked coagulation disorder resulting from a congenital~     deficiency or absence of circulating factor VIII (Haemophilia A) or factor IX (Haemophilia~     B).As a consequence, patients with haemophilia are unable to generate adequate thrombin~     resulting in abnormal bleeding. Approximately 80-90% of bleeding episodes occur in the~     musculoskeletal system, especially in the large synovial joints and muscles. Repeated~     haemarthrosis induce joint cartilage damage and irreversible degenerative joint disease.~      Regular intravenous administration of coagulation factor concentrates starting after the~     first joint bleed and/or before the age of 2 ('primary' prophylaxis) is now the~     evidence-based, first-choice treatment in children with severe haemophilia. This primary~     prophylaxis has radically decreased the incidence of arthropathy in patients with~     haemophilia. Despite the positive effect of primary prophylaxis on arthropathy at several~     joints, the ankle joint seems to be an exception to the rule, as patients with haemophilia~     treated with primary prophylaxis still experience ankle arthropathy. As such, the ankle now~     is the main affected joint in patients with haemophilia under the age of 20. This makes the~     scientific community facing a new challenge. Determining aetiologic/contributing factors~     associated to the ankle arthropathy pathophysiological cascade in children with haemophilia~     (CwH) is therefore a primary objective in the haemophilic research community nowadays.~      Loading of the ankle is crucial as the ankle plantar flexors provide the main propulsive~     power during gait, the tibiotalar joint caries a complex distribution of joint stresses as a~     consequence of talar morphology and kinematics and, from a biomechanical and biochemical~     viewpoint, differs significantly from other major lower limb joints. Previous biomechanical~     studies focused on kinematic and strength measures, however, they omitted to incorporate~     fundamental measures of joint loading (joint kinetics) and joint structural integrity (JSI,~     assessment of soft tissue and osteochondral integrity through MRI). This makes it impossible~     to draw firm conclusions on biomechanical contributing factors. Furthermore, few, low-quality~     studies focused on conservative treatment strategies (e.g. strength training, mobilisation,~     proprioceptive training) in patients with ankle arthropathy. In a minority of the cases,~     important adverse effects (joint bleeding during strength and proprioception training) have~     been reported. Because of the low quality of the intervention studies and the lack of~     biomechanical studies focusing on joint loading and joint integrity, it is impossible to~     pinpoint the aetiology of these side effects. One assumption might be that side effects~     originate from inappropriate conservative approaches as a consequence of lacking knowledge on~     joint loading and joint integrity.~      An innovative approach within the domain of ankle arthropathy in CwH is therefore to study~     foot and lower limb kinetics during gait. The quantification of foot joints kinetics~     encompasses considerable challenges and, until recently, only simplified single-segment foot~     models have been used. Those models typically underestimate the mechanical contribution of~     the different foot joints and, of equal importance, overestimate the kinetic contribution of~     the tibiotalar joint.~      To overcome the above mentioned shortcomings, a valid 3D Multisegment Foot Kinetic Model~     (3DMFKM) should be developed and introduced within the population of CwH. This is important~     as it allows to quantify increased loading at the tibiotalar joint (or other joints) that may~     help to explain this ankle arthropathy in these patients. This will have been missed by~     previous research due to the consideration of the foot as one entire segment.~      Providing a classification system based on these kinetic data would, in a second stage, be a~     pertinent and valuable approach as this provides a rationale for designing randomized~     controlled trials.~      In this perspective, it is also recommended to assess the relationship with other~     biomechanical and anatomical determinants, especially if one aims at developing optimal~     management and rehabilitation strategies.~   "
102221|NCT02229318|"~     Subjects will be asked to substitute their usual vitamin and mineral supplement/s with~     FruitiVits for seven consecutive days.~   "
102222|NCT02229305|"~     This study focused on youths who were referred to community-based mental healths clinics for~     problems related to disruptive behaviors, depression, anxiety, traumatic stress, and any~     combination of these problems. Therapists were randomly assigned to deliver usual treatment~     procedures (usual care, or UC) in their clinics or an evidence-based, modularized treatment~     (Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, or Conduct~     Problems, or MATCH-ADTC). Assessments were conducted at pre-treatment and post-treatment, and~     every 3 to 6 months for two years. Results will address critical questions about deployment~     of evidence-based youth practices to clinical settings.~   "
102223|NCT02229292|"~     Purpose of the study:~        -  To evaluate the effect of tranexamic acid (TXA) of intraoperative blood loss in patients~          subjected to bi-maxillary orthognathic surgery~        -  To evaluate the potential effect of TXA on fibrin structure~        -  To evaluate the potential effect of TXA of binding of plasminogen to fibrin~        -  To evaluate the potential effect of TXA on postoperative edema formation.~      Hypothesis:~      H0: Intraoperative bleeding cannot be significantly reduced by preoperative administration of~     tranexamic acid~      H0,1: Postoperative edema cannot be significantly reduced by preoperative administration of~     tranexamic acid~   "
102224|NCT02229279|"~     The objective of this study is to assess the medical and economic relevance of teleconsulting~     for Rehabilitation After Hip and Knee Surgical Procedures.~   "
102225|NCT02229266|"~     The trial investigates the efficacy of adoptive immunotherapy with haploidentical natural~     killer cells compared to standard chemotherapy (after first complete remission) in patients~     with a high-risk acute myeloid leukemia being older than 65 years of age and not eligible for~     allogeneic transplantation~   "
102226|NCT02229253|"~     Patients with prostate cancer and a history of cardiovascular disease treated with degarelix~     for their prostate cancer, will be followed for a period of one year. In this real-life,~     non-interventional trial, any cardiovascular events occurring during degarelix therapy will~     be documented.~   "
102644|NCT02223819|"~     The study is designed to determine the 32 month rate of distant relapse in patients with~     uveal melanoma who are at high risk of recurrence following definitive therapy with surgery~     or radiation who receive adjuvant crizotinib; and secondarily, the overall survival and~     disease specific survival in this patient population.~   "
102227|NCT02229240|"~     This Phase IIIb, randomized, double-blind, parallel-group, placebo-controlled, multicenter,~     treat-to-target study of 26 weeks treatment duration will evaluate the efficacy and safety of~     once-weekly albiglutide versus placebo as add-on to intensified basal-bolus insulin therapy~     (with or without metformin) in subjects with Type 2 Diabetes Mellitus (T2DM). Approximately~     450 subjects will be randomly assigned in a 1:1 ratio to 1 of 2 treatment groups: albiglutide~     + intensified basal-bolus insulin therapy (with or without metformin) or placebo +~     intensified basal-bolus insulin therapy (with or without metformin. The total duration of a~     subject's participation will be approximately 32 weeks.~   "
102228|NCT02229227|"~     This Phase IIIb, randomized, open-label, parallel group, active control, multicenter, treat~     to-target study of 26 weeks' treatment duration will evaluate the efficacy and safety of~     once-weekly albiglutide as replacement of prandial insulin in subjects with type 2 diabetes~     mellitus (T2DM) failing to achieve adequate glycemic control on their current basal bolus~     insulin regimen (with or without metformin). Approximately 794 subjects will be randomly~     assigned in a 1:1 ratio to 1 of 2 treatment groups: albiglutide + insulin glargine (with~     insulin lispro discontinuation at Week 4) (with or without metformin) or to intensification~     of insulin glargine + insulin lispro (with or without metformin). The study will comprise 4~     study periods : Screening (2 weeks), Standardization (4 weeks), Treatment (26 weeks), and~     Post treatment Follow up (4 weeks). The total duration of a subject's participation will be~     approximately 36 weeks.~   "
102229|NCT02229214|"~     The main purpose of this study is measure the effect of VI-0521 on kidney function.~     Specifically, glomerular filtration rate (GFR) will be measured at baseline, after 4 weeks of~     study treatment, and after an additional 4 weeks of off-treatment recovery.~   "
102230|NCT02229201|"~     Anaesthesia and surgical stress during craniotomy can lead to brain damage and activation of~     inflammatory response. Consequently inflammatory cytokines (IL6, IL8, IL10) are released.~     Cell mediated immune balance can increase postoperative complications (infections, wound~     healing, multiple organ dysfunction). Many studies have shown that volatile anaesthetics~     reduce systemic and local inflammatory response during major surgery, but animal studies have~     shown that volatile anaesthetics can induce neuroinflammation (IL6, NF-κB) that leads to~     decline of cognitive function in rodent and possible human.~      Our aim was to investigate how anaesthetic technique for craniotomy influences the release of~     inflammatory cytokines. Our hypothesis was that when optimal neuroprotective strategies are~     followed during surgery intravenous anaesthesia attenuates inflammatory response comparing to~     inhalational anaesthesia.~      The investigators included 40 patients anaesthetised with remifentanil based anaesthesia with~     sevoflurane (S group) or propofol (P group).~      Plasma levels of IL6, IL8, IL10 were measured during preoperative, perioperative and~     postoperative periods of both groups of patients. The investigators also noted emergence~     parameters, postoperative (pain, shivering, vomiting) and neurological complications after~     surgery.~   "
102231|NCT02229188|"~     This is a pilot study divided into two phases. IN phase 1 (completed) participants will be~     randomized to receive 8 weeks of Problem Solving Therapy (PST) alone or 8 weeks of a~     cognitive training game called, Evolution (Evo) plus clinical management. In Phase 2 (now~     recruiting), participants will be randomized to Evo, PST, and a different cognitive training~     program called Words. Words is similar to Evo in that it is an adaptive training program and~     includes case management. IN both studies participants will be assessed for clinical and~     functional magnetic resonance imaging (fMRI) outcomes at baseline, 4 weeks and 8 weeks.~   "
102232|NCT02229175|"~     Currently, diabetic macular edema is treated is through injection of a medications such as~     off-label bevacizumab, which decreases the swelling in the retina. These injections are~     sometimes required monthly until the condition is controlled. Recently, there have been some~     new FDA approved treatments using laser that decrease the swelling. These approximately ten~     minute treatments do not require injections and don't cause permanent damage to the eye, and~     they may decrease the number of injections one needs to get to treat diabetic macular edema~     (DME).~      The purpose of this randomized clinical trial is to determine whether subvisible laser in~     combination with intravitreal bevacizumab is non-inferior compared to current standard of~     care (intravitreal bevacizumab alone) in achieving favorable outcomes for visual acuity, mean~     macular thickness, and patient quality of life, and has fewer needed intravitreal bevacizumab~     injections throughout the course of the 12 month study period.~   "
102233|NCT02229162|"~     This is a pilot study of delayed cord clamping (DCC) at progressively longer intervals (90 to~     120 seconds) during elective cesarean deliveries of term infants. The investigators~     hypothesize that the pilot trial of DCC in cesarean sections will demonstrate safety of this~     procedure for mothers and babies.~   "
102234|NCT02229149|"~     This randomized phase 2 study will seek to determine the effectiveness of chemotherapy~     (physician's choice of vinorelbine, taxane [paclitaxel, docetaxel or nab paclitaxel] or~     capecitabine) plus trastuzumab vs chemotherapy (physician's choice) plus trastuzumab plus~     pertuzumab in women with HER2-overexpressing metastatic breast (MBC) that has been previously~     treated with ado-trastuzumab emtansine (T-DM1) in the metastatic setting.~   "
102235|NCT02229136|"~     This is a randomized Phase 2 study to evaluate two different steroid-based mouth rinses~     (Miracle Mouth Wash plus hydrocortisone versus prednisolone oral rinse) for the prevention or~     treatment of everolimus-associated stomatitis (mouth sores) in postmenopausal patients~     undergoing treatment with an aromatase inhibitor plus everolimus. An exploratory analysis~     will also evaluate patient response to next anti-cancer therapy of physician's choice~     following discontinuation of therapy with an aromatase inhibitor plus everolimus.~   "
102236|NCT02229123|"~     LEVNEONAT is a multicentre French clinical trials with the aim to develop new treatment~     strategies for the treatment of neonatal seizures using Levetiracetam. The purpose of this~     study is to determine the correct dosing, safety and efficacy for intravenous levetiracetam~     as first line treatment in term newborn babies with seizures in hypoxic-ischemic~     encephalopathy context. This new anticonvulsivant drug is a promising treatment for seizures~     in newborns.~   "
102373|NCT02227342|"~     Manipulation of the intestinal microbiota through FMT is a potential therapeutic target for~     IBD patients. Studies are now required to determine if repeated FMT can overcome the apparent~     immune response to FMT thereby maintaining sustained clinical improvement and remission.~     Prior to a large randomized controlled trial of FMT in UC we will carry out a feasibility~     study to determine if serial FMTs can sustain a clinical response and maintain stability of~     transplanted microbiota.~   "
102237|NCT02229110|"~     Patients with type 2 diabetes mellitus can receive care in the general practice or at the~     outpatient clinic. In the region of Amersfoort in The Netherlands, primary care practices and~     the hospital are connected through Diamuraal to organize the diabetes care in that region.~     They work in the same electronic medical record, and patients can request access to their own~     record (called a patient web portal). They set up Diamuraal guidelines, based on the~     guidelines of the Dutch College of General Practitioners and Internists, on where the patient~     care needs to be allocated (primary or secondary care), depending on the amount of specific~     care a patient needs. Despite guidelines, not all patients are treated in the correct place.~      Our hypotheses is that when we improve triage we can cause a major shift from treatment in~     secondary care to primary care and from primary care to self-care by using the patient web~     portal. Furthermore, patients who needs extra attention due to problems with their diabetes~     or complications can receive this extra attention due to increased e-consultation between~     primary care and secondary care and if necessary actually can, during a short time, be~     treated by an internist. We hope to achieve this by introducing a signal in the electronic~     medical record. This signal allocates patients according to the guidelines and warns a~     physician if their patients is not treated according to that guideline. The health care~     provider can then discuss this situation with his patient. We believe that this leads to~     shift in allocation of care, in which optimal care is provided and patients are made more~     aware of their situation which hopefully leads to better self-management and satisfaction.~   "
102238|NCT02229097|"~     A recent study suggests that, in Type 1 Diabetes (T1D) patients treated by insulin pumps, a~     better coordination of meal boluses and post prandial basal rate could reduce the importance~     of postprandial hyperglycaemias without increasing the risk of delayed hypoglycaemias.~      The aim of the investigators study is to assess if these results are confirmed in a clinical~     trial.~      The aim of this study is to compare the efficacy of coordinated boluses versus normal boluses~     on postprandial glycaemic control of T1D patients treated with continuous subcutaneous~     insulin infusion.~   "
102239|NCT02229084|"~     The purpose of this study is to evaluate an investigational agent, P10s-PADRE, a peptide~     mimotope-based vaccine, in combination with standard neoadjuvant chemotherapy in patients~     with clinical stage I, II or III estrogen-receptor (ER)-positive breast cancer.~      This is a single-arm, multi-site Phase I/II study designed with the two goals being (1) to~     evaluate the feasibility of combining vaccination with the P10s-PADRE formulation with~     neoadjuvant chemotherapy and (2) to determine if the polymerase chain reaction (pCR) rate~     among ER-positive breast-cancer patients treated with the combination is significantly higher~     than the 8% rate observed among ER-positive breast-cancer subjects in a pooled analysis of~     seven randomized clinical trials. P10s-PADRE vaccine with MONTANIDE™ ISA 51 VG as adjuvant~     will be given in combination with neoadjuvant chemotherapy in female patients with clinical~     stage I, II or III ER-positive breast cancer.~   "
102240|NCT02229071|"~     This phase IB study of donafenib, an oral multikinase inhibitor that targets Raf kinase and~     receptor tyrosine kinases, is to assess toxicity,efficacy and pharmacokinetics in patients~     wiht advanced hepatocellular carcinoma (HCC) .~   "
102241|NCT02229058|"~     The purpose of this study is to evaluate the effectiveness and safety of s-1 plus Albumin~     Bound Paclitaxel as first-line therapy in the treatment of patients with advanced gastric~     cancer.~   "
102242|NCT02229045|"~     The purpose of this study is to evaluate the effectiveness and safety of albumin bound~     paclitaxel plus 5-FU and as second-line therapy in the treatment of taxanes naive patients~     with advanced gastric cancer.~   "
102243|NCT02229032|"~     There is tremendous curiosity about medical marijuana and the treatment of epilepsy. In a~     specific genetic epilepsy known as Dravet Syndrome, a mutation occurs affecting the SCN1A~     gene. A specific strain of marijuana known as Charlotte's Web, available in Colorado, may~     have activity in this catastrophic epilepsy syndrome. Anecdotal reports suggest both success~     and lack of response with this therapy. Genetic analysis of the differences between Dravet~     responders and non-responders may prove useful for identifying patients likely to be helped~     by this therapy, as well as shed light on the putative mechanisms by which marijuana may~     exert any antiepileptic effect.~   "
102244|NCT02229019|"~     The Southampton Mealtime Assistance Study aims to determine whether it is feasible and~     acceptable to introduce trained volunteers as mealtime assistants in five different~     departments of one large hospital.~   "
102245|NCT02229006|"~     The purpose of this study is to determine whether Sodium Fluoride imaging (using Positron~     Emission Tomography-Computed Tomography - PET-CT) is able to help predict the rate of~     abdominal aortic aneurysm expansion.~   "
102246|NCT02228993|"~     Awake craniotomy (AC) is an anesthetic and surgical technique commonly used to resect tumors~     involving or adjacent to the eloquent or motor cortices, those portions of the brain that are~     responsible for language and motor skills, respectively. By mapping those areas of the brain~     that are necessary for such functions, the neurosurgeon is able to avoid resection of~     cortical tissue that might compromise the patient's abilities to speak or move, hence~     preserving neurologic function. AC is often accomplished by direct cortical stimulation or~     inhibition, while maintaining the patient's ability to interact with the operative team. The~     anesthetic technique often involves a regional (scalp) block combined with intraoperative~     intravenous mild sedation. In some reported instances of AC, no cortical mapping is~     performed, and the technique is performed solely because it is thought that AC leads to a~     better recovery profile (less pain, better neurologic outcome, and shorter hospital stay)~     than craniotomy performed under general anesthesia.~      The Quality of Recovery Score (QoR-40) is a validated, multi-parameter instrument that has~     been used in various postoperative populations to assess the overall satisfaction and~     well-being of patients having undergone anesthesia and surgery. Leslie et al. have reported~     that the QoR-40 is a valid tool in assessing neurosurgical patients, but a direct comparison~     between AC patients and general anesthesia craniotomy (GAC) patients using this tool has~     never been performed.~      AC may also be associated with better 30 and 90 day multi-parameter outcomes than GAC. The~     well-validated Acute Short Form (SF-12) health survey, an abbreviated version of the SF-36,~     consists of 12 items. It measures two domains, including mental and physical component~     summaries (mental component summary and physical composite score, respectively).~      Hypothesis:~      Awake craniotomy for tumor resection is associated with a better multi-parameter quality of~     recovery in the immediate postoperative period, and better 30 and 90 day quality of life~     outcomes, than craniotomy performed under general anesthesia.~   "
102247|NCT02228980|"~     The main purpose of this trial is to describe the product profile in terms of immunogenicity~     and safety following administration of trivalent influenza vaccine (split-virion,~     inactivated) produced at Shenzhen (SP Shz TIV).~      Primary objective:~        -  To describe in each group the immune response induced by a single dose (subjects aged ≥~          3 years) or by two doses (subjects aged 6 to 35 months) of SP Shz-TIV.~      Secondary objective:~        -  To describe in each group the safety profile of the vaccine after a single dose~          (subjects aged ≥ 3 years) or after each and any dose administered (subjects aged 6-35~          months).~   "
102248|NCT02228967|"~     An alcohol Screening, Brief Intervention and Referral to Treatment (SBIRT) approach will be~     adapted for use in a large military hospital setting, and then pilot tested in a military~     emergency department (ED) to assess its potential for effectiveness and for further testing~     in a large-scale trial. SBIRT is an opportunistic approach whereby all adult patients in~     the ED are screened by Health Educators for their alcohol use, and then, taking advantage of~     a teachable moment, are delivered a brief, motivational intervention matched to their level~     of risk.~      The feasibility/formative research activities in the first phase (Phase I) of the study are~     not summative research, and therefore, do not lend themselves to testable hypotheses.~     Hypotheses with regard to the pilot randomized trial in Phase II are as follows:~        1. Participants in the SBIRT intervention will show relatively greater reductions over a~          six month period (or less increase) than the brochure/usual care control group in the~          prevalence of past-month heavy drinking, frequency of heavy drinking, past week number~          of drinks, and the AUDIT-based drinkers' index.~        2. Alcohol use-related motivation/readiness to change and controlled drinking self-efficacy~          will show greater change in the SBIRT intervention group relative to the brochure/usual~          care control group.~           In addition, exploratory analyses will examine the following:~        3. Sociodemographic/military variables (e.g., age, race/ethnicity, gender, branch of~          service, officer/enlisted status, PTS) and social-psychological factors (e.g., baseline~          readiness to change, self efficacy) will mediate or moderate changes in alcohol misuse.~   "
102249|NCT02228954|"~     Rationale. In part of the patients with good and intermediate risk metastatic renal cell~     carcinoma (mRCC) the disease course is indolent and immediate start of systemic therapy is~     not necessary. By now, the investigators are not able to identify those patients with~     indolent disease and the minor group of patients with rapidly progressive disease. In~     patients with indolent disease, a watchful waiting period is preferred, since their quality~     of life will not be unnecessary hampered by adverse events and therapy resistance is not~     induced. This study aims to identify those patients for whom a watchful waiting period is~     possible by molecular imaging. Furthermore several types of systemic therapy are possible~     once the progression is proven. These systemic treatments are comparable in terms of~     efficacy, but not in terms of toxicity and their impact on quality of life. As a secondary~     objective, the usefulness of a decision aid guiding the choice of the patients is studied.~      Objectives.~      To assess in patients with good or intermediate prognosis mRCC who are eligible for watchful~     waiting, the added value beyond clinical work-up of:~        1. FDG-PET and 89Zr-girentuximab-PET results measured at presentation to predict rapid~          progression (≤ 2 months after the baseline scan) under watchful waiting.~        2. FDG-PET and 89Zr-girentuximab-PET results measured at presentation to predict prolonged~          indolent (≥12 months after the baseline scan) disease under watchful waiting.~      To assess the value of a therapy choice decision aid for patients with progressive disease.~      Study design. This is a multicenter non-blinded prospective observational study in 80 good~     and intermediate prognosis mRCC patients.~      Study population. Patients with good or intermediate prognosis mRCC according to the Heng~     criteria, ≥18 years, without contra-indications for a watchful waiting period, able to~     provide informed consent.~      Intervention. At baseline an FDG-PET-CT and 89Zr-girentuximab-PET will be made. During the~     watchful waiting period, disease evaluation by CT according to the RECIST criteria will be~     made frequently, until established progressive disease. At that moment, a second FDG-PET-CT~     and, in case of a positive 89Zr-girentuximab-PET-scan at baseline, a second~     89Zr-girentuximab-PET will be performed and the decision aid is used to help the patient to~     choose their best treatment out of four options; pazopanib, sunitinib, combined interferon-α~     with bevacizumab and (only in case of a positive 89Zr-girentuximab-PET) radioimmunotherapy~     (RIT) with 177lutetium labelled girentuximab. Participation in the RIT trial is part of a~     separate phase II study.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness.~      At baseline, a 18F-FDG-PET-CT and 89Zr-Girentuximab-PET will be performed. During the~     watchful waiting period CT's will be made. During therapy, follow-up will include standard~     laboratory analysis, and CT-scans on regular visits to the outpatient clinic. Side effects of~     the medication and adverse events as a consequence of the tumor biopsies may occur. The~     radiation exposure of both PET investigations is acceptable and requires no shielding after~     injection of 89Zr-labelled girentuximab. Patients may benefit from disease regression or~     stabilization. All three treatment choices has proven clinical benefit in this patient~     population. The risks of participation into the RIT trial are described in the phase II trial~     protocol, which already has been judged by the Medical Ethics Review Committee.~   "
102250|NCT02228941|"~     Hyper IgE syndrome (HIES) is a rare and complex primary immunodeficiency that affects~     multiple systems. It is characterized by elevated Immunoglobulin E(IgE), recurrent skin and~     pulmonary infections and eczematoid dermatitis.Somatic manifestations include scoliosis,~     joint hyperextensibility, impaired shedding of deciduous teeth and facial dysmorphism.~      The reason of extremely high level of serum IgE in the patients with HIES is unknown. Signal~     transducers and activators of transcription 3(STAT3) gene mutations can cause the STAT3/Janus~     kinase(STAT3/JAK) signal transduction pathway disorder, then can affect the B cell~     development.~      It is reported that levels of extracellular signal cytokine and the prolonged half-life of~     IgE are not the causes of dramatically increased IgE levels in STAT3-HIES patients. According~     to our preliminary work, we found that the slight increase of IgE-secreting plasma cells~     could not explain the tremendously increased IgE level and that the key class switch~     recombination enzyme (AID) was up-regulated in STAT3-HIES patients. Intriguingly, we found~     that deregulation of immunoglobulin class switch recombination (CSR) in IgE secreting plasma~     cells in STAT3-HIES patients might play a key role in dramatically increased IgE levels.~      Nuclear factor IL-3 regulated (NFIL3) is a newly discovered transcriptional factor. During~     STAT3-HIES IgE-secreting plasma cells differentiating, NFIL3 was significantly upregulated.~     The CSR of IgE was down-regulated in STAT3-deficiency mice as well as NFIL3-deficiency mice,~     however Interleukin-4（IL-4）, a STAT3-independent cytokine, promotes NFIL3 expression by~     Signal transducers and activators of transcription 6(STAT6) dependent manner. Thus, we~     hypothesize that NFIL3 may play a key role in dramatically increased IgE levels in STAT3-HIES~     patients.~      In-depth insight of the pathogenic role of NFIL3 within human STAT3-HIES has great~     significance in clarifying the pathogenesis of HIES and exploiting effective targeting~     interventions to improve clinical outcomes. Also, it can provide valuable clues for the~     clinical treatment of IgE-related diseases, such as parasite infection and malignant~     diseases.~   "
102251|NCT02228928|"~     The efficacy and safety of the low concentration [0.65% (50 µg/cm2) and 1.25% (100 µg/cm2)]~     capsaicin patches and compared them to conventional 0.075% capsaicin cream and placebo patch~     in patients suffering from peripheral neuropathy~   "
102252|NCT02228915|"~     The purpose of this research study is to discover and quantitate the differences in~     post-translational modifications found in the Cu, Zn superoxide dismutase (SOD1) of patients~     with amyotrophic lateral sclerosis (ALS) as compared to healthy individuals. SOD1 is a known~     genetic cause of ALS. With certain mutations, SOD1 gains a toxic function which leads to~     motor neuron death.~   "
102253|NCT02228902|"~     Introduction: There are indications that the absorption of oral iron supplementation is~     reduced after a Roux- en -Y gastric bypass. Nevertheless, oral preparations are used as~     standard therapy for iron deficiency, even in patients who underwent a Roux- en -Y gastric~     bypass. Our goal is to evaluate if iron absorption is disturbed after a RYGB, which leads to~     a insufficient treatment of oral iron suppletion.~      Methods: an iron absorption test will be performed pre- and postoperatively in 24 patients.~     Two groups will be created.~      Preoperatively group 1 receives a daily dose of ferrous fumarate (600mg) and group 2 receives~     a daily dose Losferron (1390mg).~      Before intake of the medicines, a fasting blood sample is taken (baseline), serum iron~     including ferritin, transferrin and transferrin saturation will be measured. After intake of~     losferron/ferrous fumarate blood samples will be taken 1, 2, 3, 4, 5 and 6 hours after~     intake, using a drip. An increase of 80 microgram/l is representative for a sufficient iron~     absorption. All patients undergo a Roux- en -Y gastric bypass.~      Postoperatively; one month postoperatively the same absorption test will be repeated in the~     same patients.~   "
102254|NCT02228889|"~     The purpose of the study is to compare the clinical outcomes of two commonly used,~     FDA-approved biologic meshes in hernia repair and abdominal wall reconstruction (Strattice~     and XenMatrix). The two meshes are derived from pig skin from which cells have been removed~     and which have been sterilized. The two meshes are made by two different companies using~     different processes.~   "
102255|NCT02228876|"~     This 3-year proposal is a family-based cohort study to establish a representative sample of~     probands with ASD and their parents with well-characterized environmental, clinical~     phenotypes, endophenotypes, and genetic data to conduct CNV experiments and the~     genotype-phenotype correlations. Based on our previous findings, probands with CNVs larger~     than 500kb has been identified and their families will be newly recruit in the present~     project to reveal the origin of the CNVs and reveal the clinical feature of the families. The~     significant findings in specific genes will conduct pathway analysis to reveal the etiology~     in ASD, providing further understanding in the disease.~   "
102256|NCT02228863|"~     Concomitant use of botulinum toxin and robot would make better results regarding upper~     extremity function compared to robot, botulinum toxin, or no intervention.~   "
102257|NCT02228850|"~     The purpose of this study is to evaluate pharmacodynamics (PD) in adult subjects with a~     diagnosis of Raynaud's Phenomenon secondary to Systemic Sclerosis (SSc).~   "
102311|NCT02228148|"~     The purpose of this study is to evaluate if the new and simplified fitting method with~     Cochlear Nucleus Fitting Software (a major component of a suite of tools which form the~     Clinical Care Innovation) provides Cochlear Implants Recipients with the same hearing outcome~     as the current and established clinical fitting method with Cochlear Nucleus Custom SoundTM~     Suite. The Clinical Care Innovation method reduces fitting to simple volume, bass and trebles~     adjustments, operations which are familiar to anyone who has used an audio player.~   "
102312|NCT02228135|"~     This is a retrospective chart review looking at the effect of dexamethasone dosing on~     post-tonsillectomy hemorrhage.~   "
102258|NCT02228837|"~     The hypothesis of this study is that the daily consumption of 2 medium-sized pears for twelve~     weeks will improve blood pressure, lipid profiles, glycemic control and insulin resistance,~     inflammatory and oxidative status in men and women with metabolic syndrome. 50 men and women~     between the ages of 45 and 65 who have three of the five features of metabolic syndrome as~     defined by the Adult Treatment Panel III will be included in the study. After a two-week~     run-in phase, eligible men and women will be randomly assigned to one of two treatment~     groups: 1) 2 medium-sized pears; or 2) 50 g placebo powder daily for twelve weeks. After an~     initial telephone screening, all participants will be requested to report to the study site~     for their first visit. On the first visit (screening), participants will be provided with~     verbal and written explanation of the project. They will then be asked to sign an informed~     consent form, followed by measuring waist circumference, resting brachial blood pressure,~     fasting serum triglycerides, high density lipoprotein cholesterol, and glucose levels to~     confirm metabolic syndrome. Baseline assessments will be performed for medical history,~     medication use, dietary intake, and physical activity. Qualified participants will be~     scheduled for their second visit two weeks later (actual baseline data collection) and~     randomly assigned to their treatment group. On the second (baseline) visit between the hours~     of 6-11 A.M., blood pressure will be measured followed by blood draw and urine collection.~     Anthropometrics and body composition will be measured. Questionnaires regarding diet,~     physical activity, and gastrointestinal health will be performed. Participants will be~     provided with their assigned treatment and will receive standard instructions on how to fill~     out daily diaries for their treatment. All assessments will be repeated at 6- (third visit),~     and 12-week (final visit) intervals. All assessments and information will be collected after~     an overnight fast and 12 hours after the abstinence of caffeine and/or 24 hours after the~     last bout of moderate to heavy physical activity. After the initial 12 weeks, participants~     will undergo a 4-week washout period in which they will not consume either the intervention~     or the placebo. After the 4-week washout period, participants will crossover into the other~     group to receive either the intervention or placebo.~   "
102259|NCT02228824|"~     The purpose of this research study is to investigate the impact of different nicotine levels~     in cigarettes among non-daily smokers. This research may help inform the Food and Drug~     Administration (FDA) on how best to regulate tobacco products in the future, with the goal of~     improving public health.~   "
102260|NCT02228811|"~     The main purpose of this study is to investigate the safety of the investigational drug~     DCC-2701 and whether it will work to help people who have advanced solid tumors or cancer~     that has spread to other parts of the body.~   "
102261|NCT02228798|"~     The aim of the Perioperative Anticoagulant Use for Surgery Evaluation (PAUSE) Study, is to~     establish a safe, standardized protocol for the perioperative management of patients with~     atrial fibrillation (AF) who are receiving a novel oral anticoagulant (DOAC) drug, either~     dabigatran, rivaroxaban or apixaban, and require an elective surgery/procedure.~   "
102262|NCT02228785|"~     This study was designed to investigate the safety and tolerance of three doses (100µg, 200µg,~     500µg) of G17DT for the treatment of patients with colorectal cancer.~   "
102263|NCT02228772|"~     This research study is evaluating a combination of drugs considered standard treatment for~     children and young adults with acute lymphoblastic leukemia (ALL), in combination with a new~     drug called MLN 9708. Additionally, the study is also evaluating if bone marrow or stem cell~     transplantation, which will be given to some participants, helps to prevent ALL from~     returning.~   "
102264|NCT02228759|"~     Patients scheduled to undergo total knee arthroplasty will receive motor sparing knee blocks~     with continuous adductor canal block along with multimodal analgesia started pre-operatively~     and continued into the postoperative period. The study will evaluate the feasibility of home~     discharge within the first 24 hours following total knee arthroplasty. We will also evaluate~     the pain scores in the first 5 days following the surgery, causes of delayed discharge and~     any adverse events.~   "
102265|NCT02228746|"~     Clinical intervention on overweight or moderately obeses adults. The objective of this trial~     is to demonstrate the superior eficacy of Alphagos to placebo on weight loss during a~     low-calorie diet of 12 weeks. The superiority is judged on body weight. Change in~     cardiometabolic risk factors through the intervention have been evaluated as secondary~     endpoints~   "
102266|NCT02228733|"~     This single ascending dose (SAD) study in healthy subjects will evaluate the safety,~     tolerability and pharmacokinetics of KBP-5074. PK/PD (plasma aldosterone, serum potassium and~     urine albumin levels) relationships will be explored to support the selection of dosing~     regimens of KBP-5074 that are suitable for the Phase 2 dose-finding study to evaluate the~     efficacy, safety and tolerability of KBP-5074 in patients that could slow the progression of~     nephropathy as well as control hypertension.~   "
102267|NCT02228720|"~     This is a feasibility study is to assess the performance, safety and initial signals of~     efficacy of the drug-eluting Propel Nova Sinus Implant when used in chronic sinusitis~     patients undergoing sinus surgery of peripheral sinus ostia.~   "
102268|NCT02228707|"~     The primary objectives of the study are to evaluate the safety and tolerability of multiple~     doses of BIIB061 administered to healthy adults. The secondary objective is to determine the~     multiple-dose PK profile of BIIB061 in this study population.~   "
102269|NCT02228694|"~     An automated dispensing cabinet (ADC) is a computerized drug storage device or cabinet~     designed for hospitals. ADCs allow medications to be stored and dispensed near the point of~     care while controlling and tracking drug distribution.This study seeks to obtain quantitative~     measurements of the impact of the regulated ADC System installed in select high volume units~     throughout the hospital.~   "
102270|NCT02228681|"~     The main purpose of this study is to evaluate the effectiveness of the combination of the~     drugs Everolimus and Letrozole compared to Tamoxifen and Medroxyprogesterone acetate in~     treating endometrial cancer and to determine the types and severity of side effects caused by~     treatment with these drug combinations.~   "
102283|NCT02228512|"~     Background:~      - The chemotherapy combination DA-EPOCH-RP includes the drugs etoposide (E), prednisone (P),~     vincristine (O), cyclophosphamide (C), doxorubicin (H), rituximab (R), and pomalidomide (P).~     Researchers want to see if including pomalidomide will help people with two rare lymphomas.~      Objectives:~      - To study the safety and efficacy of the chemotherapy drugs DA-EPOCH-RP.~      Eligibility:~      - Adults at least 18 years old. They must have primary effusion lymphoma or large cell~     lymphoma arising from Kaposi sarcoma Herpesvirus-associated multicentric Castleman disease.~      Design:~        -  Participants will be with screened with blood tests, scans, spinal tap, and bone marrow~          sample. They may have skin or lymph node samples taken and fluid removed from around~          some organs.~        -  Participants will have breathing and eye tests. A camera may take pictures inside their~          body.~        -  Participants will take pomalidomide alone by mouth for up to 21 days. Then they will get~          rituximab by intravenous (IV) catheter, which is a small tube that goes into a vein..~        -  Participants will have an IV inserted in an arm or chest vein to get the IV chemotherapy~          drugs, at the same time the will take pomalidomide by mouth for 5 days.~        -  They will get DA-EPOCH-RP in 21-day cycles. Most people will have 6 cycles.~        -  They will get 4 study drugs by IV for 5 days and 2 others by mouth for 5 days.~        -  They will get daily filgrastim injections in the skin until white blood counts are~          acceptable~        -  For 2 days of some cycles, methotrexate will be injected into the spinal fluid.~        -  After completing EPOCH-RP, some participants who have Kaposi sarcoma will be prescribed~          pomalidomide for 3-weeks, followed by a one week break, for up to 12 months.~        -  Participants will repeat the blood tests often. They will also have repeated medical~          history, physical exam, urine and stool tests, and pictures of any rashes associated~          with these lymphomas.~        -  Participants will have several follow-up visits over 4 years.~   "
102271|NCT02228668|"~     The aim of the S-AVANT study is to collect additional data at 8 and 10 years median follow up~     of patients previously included in the AVANT trial from December 2004 to June 2007.~      Clinical data of the AVANT trial will be updated. Neither additional examination nor~     administration of any treatment will be performed on the patients.~      330 centers in 34 countries participated to the AVANT trial (Australia, Austria , Belgium,~     Brazil, Bulgaria, Canada, China/Hong-Kong, Czeck Republic, Finland, France, Germany, Greece,~     Hungary, Israël, Italy, Japan, Korean Republic, Mexico, Netherlands, New Zealand, Norway,~     Panama, Poland, Portugal, Russia Federation, Singapore, South Africa, Spain, Sweden,~     Switzerland, Taïwan, Thaïland, United Kingdom, U.S.A).~      The AVANT study aiming at demonstrating superiority of bevacizumab in combination with~     FOLFOX-4 or XELOX compared to FOLFOX-4, did not show prolongation of DFS at 3 year when~     adding bevacizumab to chemotherapy in resected stage III colon cancer.~      Adverse events were consistent with the known safety profile of bevacizumab. However, more~     relapses and deaths due to disease progression have been observed in both bevacizumab arms.~      A more prolonged follow-up is necessary to assess overall survival and to evaluate long-term~     results and safety.~      Collection of additional follow-up data will start Q3 2014. Clinical data are to be collected~     at 8-year median follow-up (expected to be reached around Q2 2014) and at 10-year median~     follow-up (expected to be reached around Q2 2016).~      All analyses will be performed on an exploratory purpose only. An analysis at 8 years median~     follow-up and a final analysis at 10 years median follow-up will be performed in the main~     population (all randomized patients in the AVANT trial including patients lost to follow up~     or died).~   "
102272|NCT02228655|"~     FMX-8 is a new type of drug being tested for the treatment of anemia in chronic illnesses.~   "
102273|NCT02228642|"~     Patients with diabetes who develop low blood sugars (hypoglycemia) in the hospital are at~     risk for losing the ability to develop symptoms that warn them that they are having a low~     blood sugar. There is almost no available information investigating how the inability to feel~     symptoms of a low blood sugar contributes to the risk of this happening when people with~     diabetes are hospitalized. The purpose of this study is to develop a symptom score model that~     will help to identify patients at risk for low blood sugars in the hospital and to examine~     what happens to patients who do experience a low blood sugar in the hospital.~   "
102274|NCT02228629|"~     Foot complications are a common and costly problem for subjects with diabetes. Although~     Medicare provides a pair of diabetic shoes yearly for subjects with diabetes, many do not~     wear their diabetic shoes in and around their house. Instead, subjects may wear shoes, such~     as flip flops or slippers, that provide little to no protection against injuries. While~     proper house shoe is important in the prevention of diabetic foot complications, this area~     has not received much attention. The purpose of this pilot study is to assess if CrocsRx~     Medical silver cloud clogs - a lightweight clog with protective toe box, cushioning soles,~     and easy to don and doff - offer reduced dynamic plantar pressure magnitude, as compared to~     conventional house shoes, for subjects with diabetes. A Repeated Measures ANOVA study design~     will be used to assess dynamic plantar pressure in 2 shod conditions for each subject with~     the order of shoes randomized.~   "
102275|NCT02228616|"~     The purpose of this study is to evaluate the efficacy of prucalopride 2 mg, given orally once~     daily for 12 weeks, in combination with PEG or lactulose, in treatment of women with Chronic~     Constipation (CC) in whom laxatives fail to provide adequate relief, as measured by the~     percentage of subjects with a weekly average increase of 1 or more spontaneous complete bowel~     movements (SCBMs) (responders) during the 12-week treatment phase as compared to the~     baseline.~   "
102276|NCT02228603|"~     Exercise training is a core component in cardiac rehabilitation. Exercise adherence is,~     however, low after rehabilitation and the transition from supervised to unsupervised exercise~     is problematic for many patients with coronary artery disease. Therefore, it is important to~     provide extended services to improve exercise adherence and healthy lifestyle changes.~      The aim of this study is to assess the effect of a time-limited intervention following~     out-patient cardiac rehabilitation on exercise adherence and cardiovascular risk reduction.~   "
102277|NCT02228590|"~     The primary objective of this study is to evaluate the efficacy, tolerability and safety of~     single treatments of APL-130277 in 16 patients with Parkinson's Disease (PD)~   "
102278|NCT02228577|"~     This is a retrospective chart review of cases in which the CyPass Micro-Stent was implanted~     using the Model 241 Applier. The objective of this study is to characterize and evaluate the~     safety of the Model 241 Applier when used for CyPass Micro-Stent implantation.~   "
102279|NCT02228564|"~     Collect confirmatory evidence of the safety and effectiveness of the Balloon LIFESTREAM™~     Stent Graft for the treatment of stenoses and occlusion in the iliac arteries.~   "
102280|NCT02228551|"~     This point prevalence study investigates the prevalence of augmented renal clearance (i.e. a~     measured 8-hour urinary creatinine clearance >= 120 ml/min/1.73m²) in an adult non-critically~     ill abdominal and trauma surgery population. Secondary objectives are the identification of~     risk factors associated with ARC in this specific study population.~   "
102281|NCT02228538|"~     The purpose of this study is to obtain patient oriented and clinically oriented physical~     function outcomes both pre-operatively and post-operatively in patients receiving a total~     knee arthroplasty.~   "
102282|NCT02228525|"~     The purpose of this study is to see if selinexor will improve the blood counts and bone~     marrow function in people with your type of MDS.~   "
102295|NCT02228356|"~     The investigators recently published 2 phase II trials on the use of helical tomotherapy for~     oligometastatic colorectal cancer [1,2]. Despite a dose increase from 40 to 50 Gy, delivered~     in 2 weeks time, the one-year local control was 54% only [1,2]. The high local failure rate~     is probably the result of geographical misses due to tumor motion and a biologically~     effective dose (BED) of < 100 Gy. The current study will investigate whether the one-year~     local control rate can be improved to 70%, using respiration correlated CT to individualize~     the margin needed to account for tumor motion, to avoid geographical miss, together with a~     Monte Carlo or collapsed cone dose calculation algorithm delivering 50 Gy to the 80% isodose,~     allowing higher doses in the tumor core. As the concept of an internal target volume (ITV)~     may result in large margins for patients displaying metastases in high mobile organs, such as~     liver and lung, which may lead to exposure of a relatively high dose to a large volume of~     normal tissue, dynamic tumor tracking by the VERO SBRT system will be applied in those~     patients.~   "
102284|NCT02228499|"~     Background: Asthma is the most common chronic disease of childhood with a prevalence that is~     1.6 times greater in African American (AA) children than in Non-Hispanic White children.1~     Nationally, 700,000 children are seen for asthma in Emergency Departments (ED) every year, 1%~     of which are seen at Children's National Health System (CN) in Washington, DC. School~     performance and school attendance has not been well studied in urban children with asthma,~     especially at the middle school level.~      Objective: Our purpose is to test the hypothesis that middle school children with asthma have~     worse school performance than middle school children without asthma in Washington DC and~     Prince George's county schools.~      Methods: The investigators will conduct a cross-sectional observational study of~     middle-school (grades 6-8 in the 2013-2014 school year) aged children with and without asthma~     recruited from the Emergency Departments and the IMPACT DC asthma clinic at CN. The~     investigators will collect demographic information, asthma severity information (for cases),~     and request that parents mail report cards and standardized test scores directly to the~     investigators. The investigators will use multivariable linear and logistic regression to~     determine if the presence of asthma is associated with school performance.~   "
102285|NCT02228486|"~     Relapse is a major risk in substance abuse disorders, which is closely related to craving for~     a substance, describing a strong urge for consumption. Cue-exposure therapy is an~     intervention aiming at the reduction of perceived craving by repeated confrontation. It is~     based on the assumption that craving drops after repeated exposure without the reinforcing~     experience elicited by consumption. In the present study, patients with alcohol dependency~     take part in nine cue-exposure training sessions. Each session consists of mood induction~     reflecting a high risk situation with subsequent in vivo confrontation with one's preferred~     alcoholic beverage followed by the training of coping strategies. During the cue-exposure,~     patients focus on perceiving automatic responses to alcohol-related cues. We hypothesize that~     especially patients exhibiting initially high reactions to such cues should profit from this~     intervention the most. The reactions are measured on a subjective (craving) and physiological~     level (hemodynamics of the prefrontal cortex, heart rate variability, electrodermal~     activity). Furthermore, we want to strengthen the expected training effects during the~     cue-exposure by an activating transcranial direct current stimulation of the dorsolateral~     prefrontal cortex, which has been shown to be hypoactive in substance abuse disorders. We~     investigate how the cue-exposure training affects the processing of alcoholic cues~     (cue-reactivity) and its relation to clinical symptoms of alcohol dependency.~   "
102286|NCT02228473|"~     We want to evaluate the efficacy of the glycopyrrolate and atropine for the prevention of~     catheter-related bladder discomfort.~   "
102287|NCT02228460|"~     Primary Objective:~      To assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and exploratory efficacy~     of GZ/SAR402671 in enzyme replacement therapy treatment-naïve adult male participants~     diagnosed with Fabry disease.~   "
102288|NCT02228447|"~     The purpose of this study is to evaluate the impact of a multicomponent school-based~     intervention based on Bandura's Social Cognitive Theory targeting healthy eating and physical~     activity for high school adolescent girls from low-income communities in the city of São~     Paulo, Brazil.~   "
102289|NCT02228434|"~     The project aims at developing the tailored intervention strategy of childhood obesity based~     on monitoring physical activities with accelerometer and dietary behaviors using diary. It~     probably raise the passion of obese children to control weight, form healthy life style, be~     effective in sustaining weight loss and early prevent adulthood diseases.~   "
102290|NCT02228421|"~     This is a phase IV multicenter trial to evaluate the pharmacoeconomic (PE) impact of~     crizotinib and its companion diagnostic test used in a real-life setting in advanced~     ALK-positive non-small cell lung cancer (NSCLC) patients.~      NSCLC represent 80% of all new cases of lung cancer. One molecular subtype of NSCLC is the~     ALK-positive subtype. The anaplastic lymphoma kinase (ALK) is a transmembrane receptor~     tyrosine kinase. Activation of ALK occurs through the formation of gene fusions and in NSCLC,~     the gene fusion partner for ALK is primarily EML4. The resulting fusion protein is capable of~     activating the ALK kinase domain, leading to cell growth. The estimated prevalence for ALK~     rearrangements in NSCLC is 3-5%, and is more commonly found amongst patients with~     adenocarcinoma histology, in never smokers and in those who are known to be wild type for~     EGFR and KRAS.~      Crizotinib is a potent inhibitor of ALK and is approved for the treatment of advanced ALK+~     NSCLC patients. This is an example of personalized medicine, where patients are selected for~     treatment based upon a molecular assay, and are provided a specific therapy (crizotinib) for~     their disease. The pharmacoeconomic impact of using genetic information in early treatment~     decisions in NSCLC has not been determined.~      The study will enable real-life Heath Economics and Outcome Research (HEOR).~      Approximately 90 patients will be recruited. Patients will be asked to complete~     quality-of-life questionnaires at regular intervals in a real-life setting of treatment with~     crizotinib.~   "
102291|NCT02228408|"~     This study is a pilot study designed to compare the safety and cardiovascular effects of 26~     weeks of combination hydralazine/isorsorbide dinitrate therapy with placebo therapy in~     patients receiving chronic hemodialysis.~      The investigators hypothesize that treatment of chronic hemodialysis (ESRD) patients with a~     combination of hydralazine/isosorbide dinitrate compared with placebo is safe and that it~     will improve heart function as well blood flow/blood vessel supply.~   "
102292|NCT02228395|"~     This study aims to assess the safety, tolerability, and pharmacokinetics of PF-04958242 at a~     number of single ascending doses in healthy volunteers~   "
102293|NCT02228382|"~     The purpose of this study is to fulfill the post-authorization commitment made by Pfizer to~     the European Medicines Agency in providing additional safety and efficacy data in~     approximately 150 Philadelphia Chromosome Positive Chronic Myeloid Leukemia patients with~     high unmet medical need, including 75 Chronic Phase, Accelerated Phase or Blast Phase~     patients in the fourth or later line treatment setting (i.e., after treatment with at least 3~     other Tyrosine Kinase Inhibitors).~   "
102294|NCT02228369|"~     This is the first time in patient study to assess the safety, tolerability and preliminary~     efficacy of AZD3759 in patients with advanced Non Small Cell Lung Cancer (NSCLC) In this~     study, patients with Leptomeningeal Metastasis and Brain Metastasis may also be enrolled to~     assess the anti-tumour efficacy, safety, pharmacokinetics and potential biological activity~     of AZD9291~   "
102298|NCT02228317|"~     A large part of acutely ill patient's access to the health care system starts by calling the~     emergency number 1-1-2 and thereby getting in touch with the emergency medical dispatch~     center (EMDC). In most cases an ambulance is dispatched and the patient is brought to the~     hospital. These patients are not referred by a physician (eg. a GP) and represent an~     unselected subpopulation of the acutely ill patients. At present, all non-critically ill~     patients not evaluated by a pre-hospital physician are normally be transported to hospital as~     category 2 (without activated emergency lightning and sirens).A part of this patient~     population, however, is not critically ill and a proportion of these may not need hospital~     admittance . Emergency medical technicians (EM) are not allowed to treat - and- leave~     patients without a physician's involvement. If the EMT had 24/7 online access to medical~     control i.e. in form of a physician present in the EMDC , the number of patients transported~     to hospital for assessment may be reduced as well as response times for patients actually~     needing ambulance transportation. This could potentially reduce the workload on the whole~     healthcare system involved in the management of these patients - thereby potentially reducing~     costs.~      The objective of this study is to evaluate if a systematic telemedical assessment by an~     EMDC-physician of all patients who receive an ambulance but are not critically ill and would~     have a category 2 transport to hospital can reduce the number of the patients that are~     transported to hospital and save costs and time.~   "
102299|NCT02228304|"~     Prospective, multi-center 2-stage study. Stage 1 (Phase I) is open-label with all patients~     treated with the NT-503-3 ECT implant. Stage 1 (Phase I) patients will undergo explantation~     at year 2. Those who, in the opinion of the investigator, are still candidates for continued~     anti-VEGF therapy will be re-implanted with a new NT-503-3 investigational product and~     followed for an additional 12 weeks before study exit. Stage 2 (Phase II) is a separate,~     randomized, masked phase during which eligible patients will be randomized to the NT-503-3~     group or the control group.~      Clinical Hypotheses:~        -  NT-503-3 ECT is comparable to Eylea® injected intravitreally every 8 weeks in the~          prevention of vision loss due to recurrent CNV secondary to AMD~        -  NT-503-3 ECT has an acceptable safety profile~   "
102300|NCT02228291|"~     This randomized, double-blind, placebo-controlled, parallel study aims to determine the~     6-week and acute effects of daily administration of a citrus flavonoid on cardiovascular and~     intestinal health as assessed by investigation of endothelial function, blood pressure and~     heart rate, glucose/insulin metabolism, lipid profile and gut barrier function in overweigh~     subjects.~      Futhermore we aim to relate the specific intestinal (microbial) metabolism with final serum~     levels of specific metabolites of the study product.~   "
102301|NCT02228278|"~     The purpose of this study is to determine if health-related text messages sent from~     healthcare providers to overweight and obese adolescents enrolled at a pediatric lipid clinic~     will result in increased adherence to their nutrition and physical activity goals and improve~     their weight loss. The study will also assess if the volume of texts per week impacts~     outcomes.~   "
102302|NCT02228265|"~     This research trial studies molecular features and pathways in predicting drug resistance in~     patients with castration-resistant prostate cancer that has spread to other parts of the body~     and who are receiving enzalutamide. Studying samples of blood and tissue in the laboratory~     from patients receiving enzalutamide may help doctors learn more about molecular features and~     pathways that may cause prostate cancer to be resistant to the drug.~   "
102303|NCT02228252|"~     Cardiovascular disease (CVD) is one of the most important and frequent causes of death.~     Postprandial lipidemia (PPL) is an independent risk factor for CVD, besides the traditional~     risk factors e.g. hypertension, high LDL-cholesterol, family disposition of CVD and type 2~     diabetes (T2D). A high PPL is associated with an increased risk of myocardial infarction and~     stroke. Reduction of increased PPL, as a part of CVD prevention, is therefore pivotal.~     Especially in groups with increased risk of CVD, like the metabolic syndrome (MeS) and T2D.~     Identification of a simple diet-related method will possibly result in reduction of CVD in~     healthy as well as high-risk subjects.~      The aim of this project is to investigate the effect of protein quality and the time factor~     of protein consumed as pre-meal prior to a fat-rich meal on responses of triglycerides and~     apolipoprotein B48 (ApoB48). Secondarily the aim is to study the responses of glucose,~     insulin, glucagon, amino acids, inflammatory markers, incretins, rate of gastric emptying and~     metabolomics. Also satiety feeling will be measured.~      Investigators hypothesize that whey protein consumed 15 minutes prior to a fat-rich~     isocaloric meal reduces triglyceride- and ApoB48 responses more compared to casein protein~     and gluten protein consumed 15 minutes prior to the meal and whey protein consumed 30 minutes~     prior to the meal in subjects with MeS.~      The investigators research will hopefully contribute to a better understanding of how PPL can~     be modified in a simple manner. It will promote innovation to the food industry for~     development and production of healthy food products, which can be applied in the fight~     against CVD in the background population in general and high-risk people in particular. Thus,~     the results of this project can impart knowledge of great importance both to the national and~     international food industry as well as the healthcare systems.~   "
102304|NCT02228239|"~     The purpose of this study is to evaluate the effect of esketamine compared to placebo on~     driving performance as assessed by the mean difference of standard deviation of lateral~     position (SDLP) from an on-road driving test in healthy participants.~   "
102305|NCT02228226|"~     Long term follow-up of patients those who underwent arthroscopic Bankart repair using MG-1~     for dislocation of shoulder to evaluate anchor bone hole condition and ossification.~   "
102306|NCT02228213|"~     The purpose of this study is to determine whether MIS416 administered once weekly over 12~     months is safe, tolerable, and improves a range of signs and symptoms associated with~     secondary progressive multiple sclerosis.~   "
102307|NCT02228200|"~     A nurse-led care program for cancer patients receiving chemotherapy in an outpatient setting~     was formulated. The aim of the study was to assess the effect of this nurse-led care program~     on cancer patients who received neo-adjuvant/adjuvant chemotherapy in a chemotherapy day~     center in terms of quality of life, symptom experiences, self-efficacy, health care~     utilization, and satisfaction with care. Specifically, the objectives are:~        -  To compare the differences of health care utilization between the two arms.~        -  To compare the differences of cancer patients' satisfaction with care between the two~          arms.~        -  To explore the experiences of cancer patients in the intervention arm.~        -  To understand the experiences of the intervention nurses of the program and their~          opinions on further development.~   "
102308|NCT02228187|"~     The primary objective is to examine the efficacy of 8-weeks of a locally developed~     brain-computer interface based system intervention for improving attention and memory in~     healthy elderly and those with age related cognitive decline. We hypothesize that elderly who~     have completed the training program will have significant improvement in their attention and~     memory compared to the controls, based on the Repeatable Battery for the Assessment of~     Neuropsychological Status.~   "
102314|NCT02228109|"~     The purpose of this study is to use a corneal topographer, a device that is readily available~     in most optometric practices, in order to determine the position of the multifocal (MF)~     contact lens (CL) optics in relation to the optics of the eye. The specific purpose of this~     study is to evaluate if there is a relationship between the positioning of the optics of the~     study lenses and the objective and subjective visual performance as well as participant~     satisfaction. The MF CL lenses will be fitted to two groups of participants (previously~     unsuccessful vs. currently successful MF CL wearers).~      HYPOTHESES~        -  The measurement of the power distribution acquired from the Medmont E300 corneal~          topographer is effective in determining MF CL lens centration and is a predictor of MF~          CL success.~        -  There is a difference in MF CL centration, determined by corneal topography, between~          successful and unsuccessful MF CL wearers.~        -  MF CL centration, determined by corneal topography, is correlated with visual~          performance, determined by ocular aberrometry, measures of visual acuity and subjective~          satisfaction.~   "
102315|NCT02228096|"~     This is a single arm, open-label, multi-center, phase II study to determine the efficacy and~     safety of an experimental therapy called CTL019 T-cells in pediatric patients with B-cell~     acute lymphoblastic leukemia, who are refractory to standard chemotherapy regimen or relapsed~     after allogeneic stem cell transplant~   "
102316|NCT02228083|"~     To investigate the occurrence of arrhythmias in dental treatment with local anesthetic.~   "
102317|NCT02228070|"~     Measuring ocular motility and alignment is important for diagnosing different causes of~     strabismus, following patients recovering from cranial nerve palsies, preparing patients for~     strabismus surgery and follow-up post surgery. The current clinical gold standards for~     measuring ocular alignment are the Hess screen and the Harms tangent screen. These tests are~     accurate, but require patient cooperation, and are not objective because the patient has to~     indicate the position of the light he sees on the screen. Our objective is to develop an~     accurate and easy to use goggles system to measure ocular alignment and motility using 3D~     video oculography.~   "
102318|NCT02228057|"~     Injury to the blood vessels of the extremities, and more specifically the arteries, can~     result from fractures and severe crush injuries. It occurs in about 3% of the general~     population. People affected by blood vessel injuries can have important problems, including~     cold intolerance, general pain, and weakened function of the associated limb. Even after~     surgical intervention to repair the affected artery, people may still experience numbness,~     problems with movement, and an inadequate supply of oxygen to the limb. These symptoms are~     particularly relevant in the case of forearm arterial repairs because this repair directly~     affects one of our most vital structures: the hand. Despite available interventions and~     advances in microsurgical technique, arterial repairs can still result in significant sensory~     and functional impairment of the hand. Once an artery within the arm is injured, a surgeon's~     primary goal is to restore blood flow to the hand and prevent functional impairment. Even~     with a prompt effort to restore hand perfusion, long-term (greater than 6 months) sensory and~     motor function is hard to predict.~      Furthermore, sometimes the repaired artery becomes occluded over time. We believe that this~     occlusion has a direct impact on a patient's perceived pain and cold intolerance at the level~     of the hand.~      In this study, we are investigating the occurrence of blood vessel occlusion in the arm after~     at least 6 months of surgery and the impact of this event. To assess this we will use~     physical exams, non-invasive tests, duplex doppler ultrasound and questionnaires.~     Questionnaires, including the DASH (disabilities of the arm, shoulder,and hand), CISS (Cold~     Intolerance Symptom Severity Questionnaire), and Michigan hand score, will be used to assess~     pain, sensory, and motor impairments in both the affected and unaffected hand. Functional~     assessments will include 2-point discrimination, grip strength, pinch strength, capillary~     refill and range of motion.~   "
102319|NCT02228044|"~     This study examines whether an integrated alcohol/substance abuse, suicide, and HIV~     prevention protocol is associated with lower onset and frequency of alcohol and other drug~     use, suicidal behavior, and high risk sexual behavior among adolescents receiving community~     based mental health care.~   "
102320|NCT02228031|"~     The purpose of this project is to investigate the possible effect of intranasally~     administered Oxytocin (OT) on specific mirror neuron areas in human brain. The mirror neuron~     system (MNS) is thought to be involved in action perception and understanding, and may also~     underlie more complex cognitive processes such as imitation. We will use~     electroencephalographic (EEG) investigations to examine brain activity while participants~     complete two different tasks, consisting of the observation and imitation of emotional facial~     expressions (video presented) and the observation and execution of simple grasping actions~     (live presented), respectively. In addition, before the beginning of the EEG recording~     session, subjects will be randomly assigned to two different groups (Oxytocin or Placebo~     group) and will receive a dose of either intranasal Oxytocin or Placebo solution. Oxytocin is~     a polypeptide hormone that plays a critical role in social behavior. We will identify mu and~     beta rhythm from the ongoing EEG and examine suppression as a function of emotion and goal~     directed action perception and imitation/execution.~   "
102321|NCT02228018|"~     CALSA will be compared with FRI and the repeatability of the FRI parameters will be tested in~     a group of healthy volunteers and asthma patients.~   "
102322|NCT02228005|"~     The purpose of this study is to examine the effects of sertraline treatment of depression in~     older adults on gait stability, balance recovery reactions, and markers of bone metabolism.~     This is a pilot study that will determine feasibility and generate hypotheses for a larger~     definitive study.~   "
102323|NCT02227992|"~     The objective of this study is to evaluate the safety and effectiveness of EVARREST™ Sealant~     Matrix (EVARREST™ Fibrin Sealant Patch) (EVARREST™) in controlling mild or moderate soft~     tissue & parenchymal bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and~     thoracic (non-cardiac) surgery in paediatric patients.~   "
102324|NCT02227979|"~     The proposed study is designed to investigate whether the PURPLE Crying program attains~     efficacy by optimizing the neural response in the anterior insula, and augmenting activity in~     regions of the brain known to be important for emotion regulation.~      The aim is to determine the effects of the PURPLE Cry Intervention by investigating the~     following:~        -  independent variables that may affect a father's neural response to infant cries~        -  effects of the PURPLE cry intervention, compared to a control intervention, on fathers'~          reported aversiveness and empathy in response to cry stimuli~        -  effects of the PURPLE cry intervention, compared to a control intervention, on fathers'~          neural response to unknown infant cries compared to a tone control~        -  effects of the PURPLE cry intervention, compared to a control intervention, on fathers'~          neural responses to own infant cries compared to unknown infant cries~      The investigators hypothesize:~        -  prior to the PURPLE material, fathers' neural responses to infant cry stimuli will be~          modulated by the following variables: subjective self-reported emotional reaction to cry~          stimuli, hormone levels, sleep quality and quantity, sex of the infant, infant~          temperament, life stressors, parental expectations, personality (neuroticism), and~          father's own childhood experience~        -  fathers who receive the PURPLE material compared to those that receive the control~          intervention will report a larger decrease in aversiveness and a larger increase in~          empathy in response to cry stimuli~        -  fathers who receive the PURPLE material compared to those that receive the control~          intervention will show a larger decrease in activity in the anterior insula and amygdala~          in response to cry stimuli~        -  fathers who receive the PURPLE material compared to those that receive the control~          intervention will show a larger increase in activity in regions of the brain important~          for emotion regulation, such as the dorsolateral prefrontal cortex (PFC) and~          orbitofrontal PFC~        -  fathers' neural activity in the amygdala in response to their own infant's cry stimuli~          will be positively correlated with both their own and infant testosterone levels~   "
102325|NCT02227966|"~     The primary objective of this preliminary study is to investigate whether the transcranial~     direct current stimulation (tDCS) improves the cognitive function in patients with Mild~     Cognitive Impairment (MCI)~   "
102327|NCT02227940|"~     This phase I trial studies the side effects and best dose of ceritinib and combination~     chemotherapy in treating patients with solid tumors that have spread to other places in the~     body and usually cannot be cured or controlled with treatment (advanced) or pancreatic cancer~     that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or~     has spread to other places in the body (metastatic). Ceritinib may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy,~     such as gemcitabine hydrochloride, paclitaxel albumin-stabilized nanoparticle formulation,~     and cisplatin, work in different ways to stop the growth of tumor cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. Giving~     ceritinib and more than one drug (combination chemotherapy) may be a better treatment for~     solid tumors or pancreatic cancer.~   "
102328|NCT02227927|"~     Domperidone is a drug that may be of benefit to individuals with gastroesophageal reflux~     disease (GERD), with upper GI symptoms, gastroparesis, and chronic constipation.~      This is a long-term treatment program for prescription of this drug to all patients who, in~     the investigators' judgement, could benefit from its use.~   "
102329|NCT02227914|"~     The purpose of Phase 1b of the study is to determine the maximum tolerated dose,~     pharmacokinetics (PK) and pharmacodynamics (PDn) and assess the safety, tolerability and~     activity of oprozomib in combination with sorafenib in subjects with advanced hepatocellular~     carcinoma (HCC).~      The purpose of Phase 2 of the study is to evaluate the efficacy of oprozomib in combination~     with sorafenib versus sorafenib alone and to compare the key outcome measures for subjects~     with advanced HCC.~   "
102330|NCT02227901|"~     This phase I trial studies the side effects and best dose of tipifarnib when given together~     with radiation therapy and temozolomide in treating patients with newly diagnosed~     glioblastoma multiforme. Tipifarnib may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth. Radiation therapy uses high energy x rays to kill tumor~     cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the~     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Giving tipifarnib together with radiation therapy and~     temozolomide may be a better way to treat glioblastoma multiforme.~   "
102331|NCT02227888|"~     This Phase 1 study in F508del-CFTR homozygous CF patients is being conducted to assess the~     pharmacokinetics and absorption dynamics of N91115 compared with healthy subjects in order to~     identify an initial starting dose for Phase 2 trials.~   "
102332|NCT02227875|"~     To test whether Mylan's insulin glargine once daily is non-inferior to Lantus® once daily~     (both administered in combination with other anti-diabetic drugs) based on the change in~     HbA1c from baseline to 24 weeks~   "
102333|NCT02227862|"~     To test whether Mylan's insulin glargine once daily is non-inferior to Lantus® once daily~     (based on change in HbA1c from baseline to 24 weeks) when administered in combination with~     mealtime insulin lispro.~   "
102334|NCT02227849|"~     The purpose of this study is to evaluate the safety and efficacy of Canagliflozin (TA-7284)~     in combination with GLP-1 analogue in patients with type 2 Diabetes for 52 weeks.~   "
102335|NCT02227836|"~     Can allergy patch test (APT) predict of dietary therapy in patients with Eosinophilic~     Esophagitis?~   "
102336|NCT02227823|"~     The purpose of this study is to evaluate safety and efficacy of anti-cholinesterase therapy~     on the motor function in SMA type 3 patients with impaired neuromuscular junction (NMJ).~   "
102337|NCT02227810|"~     Muscle atrophy and diaphragm dysfunction are common complication in patients with prolong~     mechanical ventilator (PMV) and is associated with increased rate of weaning failure and days~     of hospitalization. Electrical stimulation (ES) has been shown to be beneficial in patients~     with severe chronic heart failure and chronic obstructive pulmonary disease. The purpose of~     this study is to examine the effects of ES on skeletal muscle function, pulmonary mechanics~     and hospitalization outcomes in patients with PMV.~   "
102338|NCT02227797|"~     The primary purpose of this study is to identify the optimal dose of voriconazole, an~     anti-fungal drug often used in people undergoing stem cell transplant. An optimal dose level~     is one level that provides a good blood level (concentration) of voriconazole without too~     much toxicity.~   "
102339|NCT02227784|"~     The purpose of the ACCENTUATE study is to evaluate whether the study drug known as~     evacetrapib is effective in treating participants with high cholesterol and atherosclerotic~     cardiovascular disease (ASCVD) and/or diabetes.~   "
102340|NCT02227771|"~     The purpose of this study is to demonstrate that enhanced vascular healing with the Synergy~     stent should minimize the risk of late aneurysm formation and potential clinical~     complications but not at the cost of enhanced efficacy.~   "
102341|NCT02227758|"~     The purpose of this study is to evaluate the long-term safety and performance of~     neurostimulation for the treatment of intractable chronic migraine as well as to detect~     infrequent complications or problems only apparent in real-world practice~   "
102350|NCT02227641|"~     In patients after allogeneic stem cell transplantation reactivation of latent herpesviruses~     such as Cytomegalovirus (CMV) and Epstein Barr Virus (EBV) is a frequent and life threatening~     complication requiring antiviral treatment. The underlying problem is a severe suppression of~     the donors immune system after transplantation into the patient. Herpesviruses such as CMV~     and EBV persist after primary infection life long in the host and therefore require constant~     immunological control. This control is largely provided by the T-cell compartment of the~     immune system. After allogeneic stem cell transplantation the T-cell compartment requires a~     long time for its reconstitution since only a small fraction of the donor T-cells are~     transplanted. During this time Herpesviruses can reoccur due to the lack of effective T-cell~     control.~      This study therefore aims at reconstituting the T-cell compartment with CMV and EBV specific~     T-cells at an early time point after allogeneic stem cell transplantation. It is mainly a~     phase I study to demonstrate that these in vitro generated T-cells can be applied safely in~     this patient population. The study also aims at demonstrating the efficacy of CMV/EBV~     specific T-cells by monitoring viral reactivation and use of antiviral drugs. The hypothesis~     is, that CMV/EBV specific T-cell can be applied safely and do not result in graft versus host~     disease and that they successfully prevent reactivation of CMV and EBV after adoptive~     transfer in patients after allogeneic stem cell transplantation.~   "
102342|NCT02227745|"~     Photocoagulation is the standard treatment in the focal EMCS, disrupts vascular leakage and~     allows the pigment epithelium remove the intraretinal fluid is effective in reducing the~     incidence of visual loss but can reduce contrast sensitivity and retinal sensitivity, the~     characteristics of the function can be reduced such as setting (location and stability) are~     relevant to the quality of the patient's vision parameters, reading comprehension, especially~     the ability, duration of diabetic macular edema, could have a significant impact on survival~     and / or the functional reserve of the macular cells subjected to mechanical and toxic~     stress-induced edema. It seems that in the treatment of patients with EMCS, photoreceptor~     damage occurs as a recent phenomenon, and can precede neurodegeneration retinal photoreceptor~     loss, whereby visual function can be decreased. An adjunctive treatment as Dorzolamide~     facilitating effect helping resorption of intraretinal fluid through EPR and reduce adverse~     events that is the loss of contrast sensitivity and retinal sensitivity, response time of~     photocoagulation treatment could be reduced to the patient, because the rate of resorption of~     intraretinal fluid is facilitated and thus the duration of the response, also could reduce~     damage to vision caused by the inadequacies of the photoreceptors during the evolution of~     macular edema avoiding moderate visual loss, there by increasing the quality of life in terms~     of improving the quality of vision in diabetic patients. In addition to obtaining a specific~     adjuvant treatment with photocoagulation is helpful for focal edema in diabetic and a new~     level using dorzolamide in retina Dorzolamide as adjunctive therapy after focal~     photocoagulation is more effective than placebo in improving visual function in patients with~     diabetic macular edema~   "
102343|NCT02227732|"~     The purpose of this study is to determine whether a new catheter is safe and effective in~     treating malignant pleural effusions.~   "
102344|NCT02227719|"~     A single center, randomized, controlled, parallel-arm study is planned to investigate~     clinical outcomes of horizontal ridge augmentation with simultaneous single implant~     placement, using the newly designed Ti-membrane. Twenty-four adult subjects who fulfill the~     inclusion criteria will be enrolled. They will be randomly placed into one of two treatment~     groups: the customized titanium membrane (Cti-mem) or the collagen membrane (CM) group as a~     control. The decision of which material to use will be made after an implant is placed.~     Primary closure of the surgical site will be attempted for 4 months (+/- 1 month), after~     which the implants will be surgically uncovered and restored. Outcome analyses will be~     performed until 1-year after the crown will be placed, or 18 months (- 1 or +4 months) from~     the implant surgery. Clinical and radiographic parameters will be compared between the two~     experimental groups. The primary outcome is linear increase of horizontal ridge width from~     direct measurements.~   "
102345|NCT02227706|"~     To evaluate the safety and effectiveness of EVICEL® Fibrin Sealant (Human) as an adjunct to~     achieve haemostasis during surgery in paediatric patients.~   "
102346|NCT02227693|"~     This is a phase 2, randomized, double-blind, placebo-controlled, parallel group study using~     avatrombopag for Japanese subjects with thrombocytopenia associated with chronic liver~     disease. This study will assess the effect of avatrombopag on platelet counts in Japanese~     subjects. Subjects will be enrolled into 2 cohorts according to the mean platelet count~     measured at Screening and Baseline. Within the lower baseline platelet count cohort (less~     than 40 x 10^9/L), subjects will be randomized in a 1:1:1:3 ratio to receive placebo, 20 mg~     avatrombopag, 40 mg avatrombopag, or 60 mg avatrombopag for 5 days. Within the higher~     baseline platelet count cohort (from 40 to less than 50 x 10^9/L), subjects will be~     randomized in a 2:1:2 ratio to receive placebo, 20 mg avatrombopag, or 40 mg avatrombopag for~     5 days.~   "
102347|NCT02227680|"~     This project studies the feasibility of (1) implementing massage therapy and music therapy~     onto a busy medical inpatient unit at Boston Medical Center, and (2) evaluating massage~     therapy and music therapy's impact on patient satisfaction, patient outcomes, and cost. The~     investigators will conduct a randomized controlled trial comparing massage therapy, music~     therapy, and usual care to collect preliminary data on critical outcomes for patients~     (satisfaction, symptom control) and for the hospital (pain medication use and length of stay,~     both critical drivers of cost). The investigators anticipate using these preliminary data to~     apply for a future larger and longer adequately powered randomized controlled trial to~     definitively answer the following research questions: does implementation of an inpatient~     massage therapy and/or music therapy service (a) improve patient satisfaction; (b) reduce~     symptoms such as pain; and (c) lower health care costs through less pain medication and~     reduced length of stay?~   "
102348|NCT02227667|"~     The purpose of this study is to find out what effects, good and/or bad, MEDI4736 has on the~     patient and cancer.~      MEDI4736 is a type of medication called an antibody. Antibodies are normal proteins in the~     body that help fight infections and possibly cancer. MEDI4736 is a special type of an~     antibody produced in a laboratory. MEDI4736 works by blocking a specific protein called the~     Programmed Death Ligand-1 (PDL-1), located on tumor cells.~   "
102349|NCT02227654|"~     The present investigation will prospectively evaluate whether serial transvaginal~     ultrasonography with Morphology Index (MI) can further reduce false positive results by more~     accurately distinguishing benign from malignant ovarian tumors. If there is no change in the~     detection of true positive cases, the result will be an increase in the positive predictive~     value of ovarian cancer screening.~   "
102351|NCT02227628|"~     A human clinical consumption trial will be performed in volunteers with increased risk~     factors for cardiovascular disease (Metabolic Syndrome), which includes obesity and diabetes~     and related conditions over a period of 12 weeks with blood draws at baseline (0 weeks), 4,~     8, and 12 weeks and a 24 hr urine collection on each blood draw day.~   "
102352|NCT02227615|"~     The objective of this research is to characterize the urinary metabolites produced after the~     consumption of mango pulp in an effort to begin to characterize the bioavailability of the~     major group of polyphenolics in mango, ester-linked gallic acids, and to provide new insight~     into their in vivo physiological behavior.~   "
102374|NCT02227329|"~     This study is being implemented to identify the role of prophylactic use of ethanol lock in~     adult patients on home parenteral nutrition (HPN). Central catheter related blood stream~     infection is a major complication in patients on HPN. The investigators hypothesize that the~     prophylactic use of ELT will decrease the number of catheter related blood stream infections~     compared to the control group. The investigators further hypothesize that with the~     introduction of prophylactic ELT, the number of infections will decrease.~   "
102353|NCT02227602|"~     Bioactive compounds from mango are bioavailable and their anti-inflammatory efficacy has been~     demonstrated in animals and humans. However, the efficacy of mangoes has not previously been~     compared with respect to mild inflammatory bowel disease. In order to justify future~     pharmacokinetic and pharmacodynamic analyses in human clinical trials, a pilot assessment to~     determine efficacy in preventing or resolving Inflammatory bowel disease is a necessary step.~     Therefore, in this aim we will determine the clinical relevance of mango as an adjuvant~     treatment to conventional therapy in Inflammatory bowel disease . The effects of mango with~     common drug treatment in mild-moderate Inflammatory bowel disease will be compared to the~     drug-treatment alone. If mango or any other polyphenolic-rich food could be identified as~     helpful in shortening or reducing severity of episodes of inflammatory bowel disease, the~     addition of polyphenolics to conventional drug treatment in Inflammatory bowel disease would~     have a significant impact on public health.~   "
102354|NCT02227589|"~     The investigators will recruit adolescents with alcohol or cannabis abuse and clinically~     significant depression. All participants will receive 12 sessions of an evidence-based~     treatment for alcohol abuse, Motivation Enhancement Therapy/Cognitive Behavior Therapy-12,~     over 12 to 14 weeks. Those who are still depressed after 4 weeks will be randomized to~     receive treatment augmentation with either an integrated cognitive behavior therapy for~     depression, delivered by their study therapist, or depression treatment-as-usual in the~     community. The study hypothesis is that integrated depression treatment will surpass~     community treatment-as-usual in efficacy.~   "
102355|NCT02227576|"~     Chemotherapy used in the treatment of primitive tumors of the central nervous system has a~     particularly important platelet toxicity compared to chemotherapy used for treatment of other~     tumors. Chemotherapy postponed for toxicity is often due to thrombocytopenia (TP). The TP~     and/or the other anomalies of coagulation, which can be spontaneous (Rogers, 2004) or induced~     (Gerber, 2006) can have dramatic consequences:~        -  specifically neurological (intratumoral bleeding with particularly important~          neovascularization) with a functional aggravation and sometimes involvement of vital~          prognosis,~        -  digestive (Garcia-Rodiguez, 2001) in patients receiving long term treatment with~          corticoids (potential gastric toxicity).~      The encouraging results from the EORTC/NCIC trial by Stupp (median survival among patients~     with newly diagnosed glioblastoma is 14.6 months with an estimated 5-year survival of 9, 8%),~     has changed the standard of care of these patients (Stupp et al., 2009). Patients with newly~     diagnosed, histologically confirmed glioblastoma receive radiotherapy (2 Gy given 5 days per~     week for 6 weeks, for a total of 60 Gy) plus continuous daily Temozolomide (75 mg per square~     meter of body-surface area per day, 7 days per week from the first to the last day of~     radiotherapy), followed by six cycles of adjuvant Temozolomide (TMZ) (150 to 200 mg per~     square meter for 5 days during each 28-day cycle). The Stupp regimen is currently the~     treatment of reference for glioblastoma and is used as a basis in various clinical studies~     with new agents.~      This study aims to evaluate Romiplostim for the treatment of TP secondary to initial TMZ~     chemotherapy of glioblastomas.~   "
102356|NCT02227563|"~     The aim of this study is to evaluate tDCS effects on schizophrenia symptoms, particularly on~     auditory verbal hallucinations. tDCS applied with cathodal (inhibitory) electrode over the~     left temporal parietal junction and anodal (excitatory) electrode over the left dorsolateral~     prefrontal cortex.~   "
102357|NCT02227550|"~     Study objective is to demonstrate that anticoagulation with the direct factor Xa inhibitor~     apixaban is not less safe than Vitamin-K-antagonists (VKA) therapy in patients undergoing~     catheter ablation of non-valvular AF in the prevention of peri-procedural complications.~      The AXAFA trial will compare peri-ablational treatment with apixaban to peri-ablational~     treatment wit VKA in a randomized trial of patients undergoing catheter ablation of atrial~     fibrillation (AF).~   "
102358|NCT02227537|"~     A multicenter, prospective, non-randomized, single-arm observational study evaluating the~     Providence nighttime bracing system in patients diagnosed with adolescence idiopathic~     scoliosis.~   "
102359|NCT02227524|"~     In this study, the investigators will examine a sample of persons with multiple sclerosis~     (MS) to determine whether their walking function and ability is different depending on which~     walking assistive device is used.~   "
102360|NCT02227511|"~     Recruitment of 28 subjects that will be randomized to consume fruit or nuts as snacks between~     regular meals for two months. Laboratory tests for cardiovascular risk factors, metabolic~     rate, liver steatosis and physical activity are investigated ahead of start of the study and~     at the end of the trial period och two months. Participants will be allowed to buy fruits or~     nuts on their own but to keep track (diaries) of the amount consumed. They will be reimbursed~     for the costs of the snacks.~   "
102361|NCT02227498|"~     The purpose of this study is to test the Argus II Retinal Prosthesis System in patients with~     severe age-related macular degeneration (AMD). The Argus II System has already been studied~     in completely blind patients with retinitis pigmentosa (RP). In RP patients, some cells of~     the retina are irrevocably damaged and the Argus II System has been found to restore some~     basic visual function. On these grounds, the device has received authorization for use on the~     European market (the CE certification) in 2011.~   "
102362|NCT02227485|"~     This is a triple-blinded randomized clinical trial to evaluate the effect of an Iranian~     traditional mouth rinse (Punica granatum Pleniflora or Golnaar mouthrinse) on treatment of~     diabetic gingivitis and compare it with chlorhexidine (0.2%).~   "
102371|NCT02227368|"~     To compare the effect of ticagrelor versus aspirin on the change in peak walking time,~     evaluated on the graded treadmill test, from one to 26 weeks post-revascularization in~     patients with peripheral artery disease who have undergone endovascular revascularization for~     moderate to severe claudication or ischemic rest pain.~   "
102372|NCT02227355|"~     This study aims to evaluate the effectiveness of Rotigotine and Levodopa combination therapy~     for younger and older patients with Parkinson's Disease under real life conditions. Effects~     on ability to perform activities of daily living, sleep, medication dose and other factors~     will be assessed.~   "
102385|NCT02227186|"~     Children in schools in which influenza vaccination clinics are held during school hours will~     have higher rates of influenza vaccination than children in control schools (no~     school-located clinics offered)~   "
108725|NCT02144337|"~     This study aims to test the feasibility of a physical activity intervention called the Steps~     To Active Kids (STAK) programme in children aged 9 - 11 years with Type 1 Diabetes Mellitus~     (T1DM).~   "
102363|NCT02227472|"~     Children with sickle cell disease (SCD) are at risk for neurobehavioral problems because of~     the impact the disease can have on the central nervous system. Specific impairments in~     working memory are particularly prevalent in school-aged children with SCD. Working memory is~     more strongly associated with school readiness and academic success than intellectual ability~     in the general population. The adverse effects of low socioeconomic status (SES) and poverty~     on cognition and neurodevelopment emerge early, before children have entered formal~     education. In addition, they affect language and executive function skills (e.g., working~     memory) more than other skills. SES is a proxy variable for other risk factors. Higher SES is~     associated with less parental stress, more supportive parenting practices, and better~     cognitive stimulation based on the availability of books, computers, and outings.~      PRIMARY OBJECTIVE:~        -  To examine working memory and school readiness in young children with sickle cell~          disease in comparison to demographically matched control children without sickle cell~          disease.~      SECONDARY OBJECTIVE:~        -  To examine the relationships of family/environmental factors (caregiver stress, parental~          responsiveness, and cognitive stimulation in the home) and disease severity to working~          memory and school readiness skills in preschool-aged children with SCD.~   "
102364|NCT02227459|"~     The purpose of this study is to evaluate the safety and tolerability of multiple doses of~     ND-L02-s0201 in subjects with moderate to extensive hepatic fibrosis.~   "
102365|NCT02227446|"~     The Vancomycin Study is a multi-center, prospective randomized controlled trial that will~     compare the proportion of deep surgical site infections within 6 months in patients treated~     with local Vancomycin powder compared to those treated without local Vancomycin powder at the~     time of fracture fixation.~   "
102366|NCT02227433|"~     This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and~     safety of BV as a single agent in elderly patients at first relapse or with primary~     refractory HL.~      BV will be administered as a single IV infusion on Day 1 of each 21-day cycle. Measures of~     anti-cancer activity will be assessed using the revised response criteria for malignant~     lymphoma (Cheson et al. 2007).~      Computed tomography (CT) scans (chest, neck, abdomen, and pelvis) will be performed at~     baseline and Cycles 4, 8, 12, and 16 and positron emission tomography (PET) scans will be~     done at baseline and Cycles 4, 8, 12 and 16. Patients will have an End of Treatment (EOT)~     assessment 30 ± 7 days after receiving their final dose of study drug. Long-term follow-up~     assessments (including survival and disease status information) will be performed every 12~     weeks until either patient death or study closure, whichever occurs first. Patients who~     discontinue study treatment with stable disease or better will have CT scans done every 12~     weeks until disease progression.~      Study Objectives~      Primary:~      • To determine the antitumor efficacy of single-agent brentuximab vedotin (BV) (1.8 mg/kg~     administered intravenously every 3 weeks) as measured by the overall objective response rate~     in elderly patients at first relapse or with primary refractory Hodgkin lymphoma (HL).~      Secondary:~        -  To assess duration of tumor control, including duration of response and progression-free~          survival~        -  To assess survival~        -  To assess the safety and tolerability of BV~      Additional:~      • To assess disease-related symptoms Study Population Eligible patients are those with first~     relapsed or primary refractory elderly HL. Patients must also have histologically-confirmed~     CD30-positive disease, fluorodeoxyglucose (FDG)-avid and measurable disease of at least 1.5~     cm, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and adequate~     hematologic, kidney, and liver function. Eligible patients must not previously have been~     treated with BV, patients must not have congestive heart failure, known cerebral/meningeal~     disease, or any active viral, bacterial, or fungal infection requiring treatment with~     antimicrobial therapy within 2 weeks prior to first study dose.~   "
102367|NCT02227420|"~     In obese individuals cortisol production and secretion is increased but the underlying~     mechanism is not known. Obesity leads to a pathological activation of the innate immune~     system partly driven by tissue production of IL-1β. Furthermore, IL-1β is also known to~     stimulate the release of adrenocorticotropin hormone (ACTH). Therefore, the investigators~     hypothesise that in obese individuals tissue inflammation stimulates ACTH via IL-1β, thereby~     explaining the observed hypercortisolism.~   "
102368|NCT02227407|"~     Ambulation would bring many physiological and psychological benefits and getting up and~     walking has been a dream for paraplegia patients.The reciprocating gait orthoses (RGOs) for~     paraplegics particularly draws research attentions because it mimics human gait pattern.But,~     the high energy consumption and low walking speeds caused the frequent abandonment or the low~     utilization of the reciprocating gait orthoses.To improve the design reducing the energy~     expenditure, it requires biomechanical analysis of the pathological gait such that the gait~     deviations and energy consuming mechanisms can be identified and remedial means can be~     implemented.~      The investigators hypotheses will include that there would exist an energy saving mechanism~     of human reciprocating locomotion based on the principle of conservation of mechanical~     energy.Secondly, kinematic and kinetic gait determinants could be derived from the energy~     saving mechanism. Finally, the control of knee joint coordinating with the hip joint~     movements would facilitate the gait progression and further reduce the energy consumption.~      The objective of this clinical trial is to evaluate the gait of paraplegic patients with~     reciprocating gait orthoses and to support the investigators research in biomechanical~     analysis, design and control of reciprocating gait orthoses for paraplegia patients. An~     experiment to study the pathological gait of paraplegia patients with an existing~     reciprocating gait orthosis will be carried out.~   "
102369|NCT02227394|"~     This study will be conducted as a randomized, double blind, double dummy two-period crossover~     study in stable asthma patients treated in accordance with the Global Initiative for Asthma~     (GINA) guidelines, will be included.~      The primary objective of this study is to evaluate the effect of the products under~     investigation on Functional respiratory imaging parameters and evaluate the particle~     deposition with Computational fluid dynamics (CFD).The secondary objectives of this study are~     to assess the effect of Z7200 and Symbicort® on lung function (spirometry and body~     plethysmography), on exercise capacity (6MWT)and on dyspnea (Borg CR10 Scale and VAS~     dyspnea). Furthermore the safety of the 2 products under investigation will be evaluated~     through monitoring of adverse events throughout the study.~   "
102370|NCT02227381|"~     Learning disability affects 3% of the population. Severe types of learning disability are~     more likely to have an underlying genetic cause but diagnosis is difficult because many~     different genetic abnormalities may be involved. Obtaining a diagnosis is important so that~     patients can be managed appropriately and their families can be given accurate information.~      We aim to use new types of genetic testing which will make it possible to screen for several~     different genetic abnormalities which cause learning disability at the same time, so~     improving the accuracy and speed of diagnosis in the group of patients with severe learning~     disability. We will focus particularly on patients where seizures and behavioural problems~     are also present.This will enable more patients to be diagnosed accurately, reduce the number~     of hospital appointments needed and ultimately be more cost- effective.~   "
102375|NCT02227316|"~     The uterine fibroid embolization (UFE) procedure is a treatment option for abnormal heavy~     menstrual bleeding and/or bulk symptoms associated with uterine fibroids and adenomyosis.~     Post UFE procedural pain and nausea are expected events. These symptoms are treated with~     current standard of care medications, including opiates.~      Intra procedure pain medications include midazolam, fentanyl and hydromorphone. Some centers~     include nonsteroidal anti-inflammatory medications (NSAIDS), including oral ibuprofen and IV~     ketorolac. Post procedural pain control is centered on a hydromorphone patient-controlled~     analgesia (PCA) infusion pump, as well as a NSAID regimen. Intra procedure and post procedure~     nausea control medications include a transcutaneous scopolamine patch and IV anti-nausea~     medications such as ondansetron and prochlorperazine.~      This study is being conducted to compare two new medications for pain, IV ibuprofen and IV~     acetaminophen, administered for 24 hours following UFE. The primary safety objective of~     non-inferiority will be met and the primary efficacy objective of superiority, decreased pain~     and nausea, will be accessed when compared to current standard of care regimens.~      This is a 4 arm, double blind, randomized, controlled study. All patients will receive~     standard of care baseline pain medications, including IV midazolam, fentanyl and~     hydromorphone intra procedure, followed by a hydromorphone PCA infusion pump post procedure.~     The 4 arms will include: [ Arm 1] IV ibuprofen/IV placebo, [Arm 2] IV acetaminophen/IV~     placebo, [Arm 3] IV ibuprofen/IV acetaminophen, and [arm 4] IV placebo/IV placebo. These~     medications will be given during the procedure and extended over a 24 hour stay.~      Arm 4 (IV placebo/IV placebo) would replicate current standard of care, and therefore will~     include IV push (IVP) ketorolac, which would be given at the end of the procedure and be~     continued every 6 hours for the 24 hour stay. An IVP of saline will be given as a control~     every 6 hours for the 24 hour stay to arms 1, 2 and 3. Pain and nausea will be measured at~     intervals prior to the procedure, throughout the stay and at 2 weeks post procedure.~   "
102376|NCT02227303|"~     The purpose of this study is to explore the effect of 8-weeks use of the Medidata Patient~     Cloud (a mobile application for capturing data directly from subjects, enabling entry of~     diary and quality of life data into internet-enabled devices) in combination with an activity~     tracker (Fitbit Flex) on health outcomes in overweight people with Type 2 Diabetes.~   "
102377|NCT02227290|"~     The study is being done to see how well the study cream works when applied once a day to~     affected area of child (where they have ringworm). The results will be compared to those seen~     with a placebo cream which has no active ingredient. Safety of the cream will also be~     measured.~   "
102378|NCT02227277|"~     The purpose of this study is to determine if treatment with pegylated interferon alpha 2b~     (peg-IFN-α2b) will reduce the amount of integrated HIV DNA in peripheral blood cells and~     tissues of individuals with chronic HIV infection receiving antiretroviral treatment (ART).~      A reduction and/or clearance of the latent viral reservoir (i.e.: virus that remains dormant~     in HIV-infected subjects receiving suppressive treatment ) is considered essential for HIV~     eradication.~      By measuring the changes in integrated proviral HIV DNA, which is considered a surrogate~     measure of the latent reservoir, the investigators will establish if peg-IFN-α2b treatment~     should be considered as a component of future viral eradication strategies.~   "
102379|NCT02227264|"~     Patients with primary hyperparathyroidism (pHPT) often present with fatigue, psychological~     and cognitive symptoms. Improvement in these symptoms after parathyroid adenomectomy (PTX)~     has been reported. But physicians lack a method to attribute the symptoms to pHPT and to~     predict the reversibility after PTX.~      This study aims to evaluate short-term calcimimetic treatment as a tool for predicting the~     outcome of PTX on muscle strength, quality of life, psychological symptoms, and cognitive~     function in patients with pHPT.~      Material and Methods: 118 patients scheduled for PTX at Karolinska University Hospital,~     Sweden, will have a four week treatment with calcimimetics (Mimpara®) before undergoing~     surgery. Biochemicals, muscle strength, quality of life, psychological symptoms and cognitive~     function will be analysed at baseline, after four week follow-up and postoperatively.~      Hypothesis: The outcome of short-term calcimimetic treatment can predict the outcome of PTX~     on muscle strength, quality of life, psychological symptoms, and cognitive function in~     patients with pHPT~   "
102380|NCT02227251|"~     A multicenter, open-label Phase 2b study of selinexor (KPT-330) in patients with~     relapsed/refractory DLBCL who have no therapeutic options of demonstrated clinical benefit.~   "
102381|NCT02227238|"~     For treatment of human immunodeficiency virus type 1(HIV-1), publicly funded programmes tend~     to follow World Health Organization (WHO) guidelines to use a non-nucleoside reverse~     transcriptase inhibitor (NNRTI) combined with two nucleoside reverse transcriptase inhibitors~     (NRTIs) for first-line antiretroviral therapy (ART); however, there is a need for further~     data on the best treatment options for people with HIV-1 who have virological failure with~     this first-line regimen. The number of patients failing on their first-line regimen is~     increasing thereby requiring a switch to second-line treatment to reduce accumulation of~     drug-resistance mutations, disease progression, HIV transmission, and death. WHO guidelines~     recommend second-line antiretroviral therapy for adults consisting of two NRTIs + a~     ritonavir-boosted protease inhibitor (PI); atazanavir (ATV) plus ritonavir (RTV) or lopinavir~     (LPV)/RTV are the preferred boosted PI options. This study is conducted to demonstrate~     non-inferior antiviral activity at 48 weeks of a dolutegravir (DTG) containing regimen~     compared to a WHO-recommended standard of care regimen for second line treatment, LPV/RTV +~     two NRTIs, in HIV-1 infected patients failing first line therapy. This study comprises of a~     Screening Phase (approximately 28 to 42 days), a Randomized Phase (Day 1 to Week 48 plus a~     4-week treatment extension), and a Continuation Phase. Approximately 612 subjects will be~     randomized 1:1 to receive DTG 50 milligram (mg) once daily or LPV/RTV (800/200 mg once daily~     or 400/100 mg twice daily, in accordance with investigator decision and local label), each~     added to an investigator selected background regimen of two NRTIs at least one of which needs~     to be fully active based on viral resistance testing at Screening. Subjects randomized to~     receive DTG who successfully complete 52 weeks of treatment will continue to have access to~     DTG until it is either locally approved and commercial supplies are available to patients or~     the patient no longer derives clinical benefit, or the patient meets a protocol-defined~     reason for discontinuation.~   "
102382|NCT02227225|"~     Postoperative delirium has been found to be associated with increased risk of future~     neurocognitive decline and mortality especially in elderly patients. Similarly, Frailty has~     been found to be associated with an increased risk of postoperative complication including~     delirium in the elderly.The purpose of this study is determine the factors affecting the~     incidence of postoperative delirium in frail elderly undergoing non-cardiac surgery in the~     Singapore population.~   "
102383|NCT02227212|"~     Primary Objective:~      To demonstrate the ease of use of the U300 pen injector in pen-naïve and insulin-naïve type 2~     diabetes mellitus (T2DM) patients in a 4-week once-daily dosing regimen with HOE901-U300.~      Secondary Objectives:~      To assess in a 4-week once-daily dosing regimen with HOE901-U300 in pen-naïve and~     insulin-naïve T2DM patients.~      The safety and usability of the U300 pen injector. The glycemic control with the U300 pen~     injector. The safety of HOE901-U300.~   "
102384|NCT02227199|"~     This phase I/II trial studies the side effects and best dose of brentuximab vedotin that can~     be combined with ifosfamide, carboplatin, and etoposide in treating patients with Hodgkin~     lymphoma that has come back (relapsed) or is not responding to treatment (refractory).~     Monoclonal antibody-drug conjugates, such as brentuximab vedotin, can block cancer growth in~     different ways by targeting certain cells. Drugs used in chemotherapy, such as ifosfamide,~     carboplatin, and etoposide, work in different ways to stop the growth of cancer cells, either~     by killing the cells, by stopping them from dividing, or by stopping them from spreading.~     Giving brentuximab vedotin together with an ifosfamide, carboplatin, and etoposide~     chemotherapy regimen may kill more cancer cells.~   "
102387|NCT02227160|"~     The investigator is conducting a hybrid efficacy-effectiveness randomized controlled trial~     with low-income African American suicide attempters. Guided by the Theory of Triadic~     Influence (TTI), this pilot randomized controlled trial aims:~        1. to determine if psychosocial group intervention (PGI) is more effective than enhanced~          treatment as usual (ETAU) in reducing suicidal behavior (ideation, attempts; primary~          outcome) and improving its correlates (depressive symptoms, hopelessness, quality of~          life) (secondary outcomes) in low-income African Americans with a recent attempt.~        2. to determine if PGI is more effective than ETAU at bolstering intrapersonal (I),~          social/situational (SS), and cultural/environmental (CE) risk and protective factors~          that mediate the condition-suicidal behavior and correlates link and thus serve as~          mechanisms of change.~        3. to determine I, SS, and CE variables that moderate the condition-suicidal behavior link~          and thus serve as predictors of intervention outcome.~      Hypothesis for Aim 1: At post-intervention and follow-up, PGI participants will evidence~     greater improvements in suicidal behavior and its correlates than those in ETAU.~      Hypothesis for Aim 2: Changes in these risk and protective factors will account for condition~     effects on outcomes: (1) psychological distress, aggression, impulsivity, substance abuse,~     low self-esteem, and suicide acceptability (I-risk); (2) perceived burdensomeness and~     thwarted belongingness, relationship discord, intimate partner violence perpetration and~     victimization (SS-risk); (3) access to a weapon and barriers to service utilization~     (CE-risk); (4) reasons for living, optimism, positive ethnic identity, effective coping, and~     spiritual well-being (I-protective); (5) overall family health and social support from family~     and friends (SS-protective); and (6) religious involvement and effectiveness of obtaining~     resources (CE-protective).~      Hypothesis for Aim 3: Individuals (1) having fewer Diagnostic and Statistical Manual of~     Mental Disorders (DSM) disorders and attachment styles characterized by positivity toward the~     self and others (I); (2) children and more limited trauma histories (SS); and (3) more daily~     hassles and less exposure to community disorder (CE) will evidence greater reductions in~     suicidal behavior and its correlates and greater enhancements in quality of life at~     post-intervention and follow-up.~   "
102388|NCT02227147|"~     The primary objective of this study is to evaluate the efficacy of 20 µg/ml 6 times a day of~     rhNGF eye drops solution (formulation containing anti-oxidant) compared to vehicle~     (formulation containing anti-oxidant) given 6 times a day. The evaluation of efficacy is~     intended as:~        -  complete healing of stage 2 (persistent epithelial defect) and 3 (corneal ulcer)~          neurotrophic keratitis (NK) as measured by the central reading center using corneal~          fluorescein staining,~        -  assessing the duration of complete healing,~        -  improvement in visual acuity and improvement in corneal sensitivity.~   "
102389|NCT02227134|"~     This is a prospective study to see whether ultrasonography can predict difficult airway~     and/or predict obstructive sleep apnea syndrome (OSAS) in children.~   "
102390|NCT02227121|"~     The proposed study is designed to characterize defibrillation efficacy in humans for the~     potential development of a new extravascular implantable cardioverter defibrillator (ICD)~     system.~   "
102391|NCT02227108|"~     The primary objective of this study is to evaluate the efficacy of moxetumomab pasudotox in~     pediatric participants with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL)~     or B-cell lymphoblastic lymphoma.~   "
102392|NCT02227095|"~     This research focuses on overweight, sedentary children whose health, cognition, and academic~     performance are therefore at risk, and who may be particularly responsive to exercise~     interventions.~      This study will determine whether regular exercise per se (i.e. compared to attention~     control, or placebo, condition) benefits children's cognition and achievement, and will~     provide insight into neural mechanisms. A substudy will examine exercise-induced changes in~     brain structure.~      Provision of comprehensive evidence for the benefits of exercise on children's health may~     reduce barriers to vigorous physical activity programs during a childhood obesity epidemic by~     persuading policymakers, schools and communities that time spent in physical activity~     enhances, rather than detracts from, learning.~   "
102393|NCT02227082|"~     The majority of breast cancer patients receive radiotherapy as part of their treatment.~     Radiotherapy improves both locoregional control and overall survival. In most patients with~     breast cancer the locoregional recurrence rate (LRR) is low, however still high LRRs are~     found in certain patient groups, especially in locally advanced, inflammatory and triple~     negative breast cancer. Olaparib is a potent PARP inhibitor developed as an anti-cancer drug~     for homologous recombination (HR) defected tumors and as a dose intensifier for chemo- and~     radiotherapy. The combination of olaparib and radiotherapy is expected to improve~     locoregional control and thereby overall survival in both breast cancer patients with a high~     probability of locoregional recurrence and patients with HR deficient tumors. However, this~     combination treatment has never been tested in humans before. The purpose of this study is to~     determine the safety and tolerability of radiotherapy to the breast and regional lymph nodes~     with concurrent olaparib.~   "
102394|NCT02227069|"~     This is a single center, randomized, controlled, within-subject comparison, multiple dose~     study to determine the irritation potential of M518101 on normal skin under occlusive patch~     condition.~      The study drug will be applied for 21 days under occlusive patch condition. The irritation~     potential of M518101 will be compared with positive, negative control and M518101 vehicle.~     The study duration is 21days and there will be at least 23 visits to study center including~     screening visit.~   "
102395|NCT02227056|"~     The purpose of this study is to investigate the influence of Methylphenidate in pediatric~     acquired brain injury population, regarding ecologic (every day) function. It is hypothesized~     that the function with treatment will improve when compared to function without treatment in~     the same patient. Improvement is expected by shortening time of execution in each specific~     task and by reduction of the amount of assistance needed.~   "
102396|NCT02227043|"~     The investigators will study the influence of fat cell size/number and adipose function on~     weight development over very long time periods (years). By comparing fat biopsies obtained at~     baseline and after >7 years, the investigators will determine the association between adipose~     morphology/function and changes in weight or development of cardiometabolic complications~     (e.g. insulin resistance, type 2 diabetes, dyslipidemia and hypertension).~   "
102397|NCT02227030|"~     Safety and pharmacokinetics after oral single rising doses of BIIB 722 CL~   "
102398|NCT02227017|"~     Study to establish the relative bioavailability of the TPV oral solution formulation (500 mg~     coadministered with RTV oral solution 200 mg) to the TPV capsule formulation (500 mg~     coadministered with RTV capsules 200 mg), with both treatments at steady-state under fasted~     and fed conditions in healthy male and female volunteers.~   "
102420|NCT02226731|"~     The purpose of this study is to evaluate the impact of early intrauterine tamponade with a~     Belfort-Dildy balloon catheter in immediate postpartum hemorrhage(IPPH) after vaginal~     delivery and refractory to first-line uterotonic treatment, ie performed at the same time as~     second line uterotonic treatment, as compared tolate intrauterine tamponade performed in case~     of failure of second line uterotonic treatment, on the final severity of PPH. ).~   "
102399|NCT02227004|"~     Pacemakers and ICD's have traditionally been accepted as contraindications to MRI due to~     safety concerns. Recent work in our laboratory as well as our pilot study of approximately~     500 patients has shown the safety of most contemporary implanted rhythm management devices in~     the MRI environment given appropriate precautions. Because the investigators have completed~     testing in animals weighing as little as 80 lbs. without incident, the investigators feel~     they can safely image children at this weight or greater (Circulation 2004; 110:475-482).~      The goal of this study is to expand on our pilot study and to develop a protocol, consistent~     with the Department of Health and Human Services (DHHS) requirements, that will increase our~     safety experience with clinically indicated MR imaging in patients with implanted cardiac~     pacemakers and ICD's.~      This is a cohort study. One thousand seven hundred patients with a clinical need for MRI will~     be recruited. Risks and Benefits associated with Magnetic Resonance (MR) imaging in the~     setting of implantable devices will be discussed and informed consent obtained. The type of~     device and leads will be ascertained. Patients will be monitored by a physician or a~     Registered Nurse (RN) with ACLS certification and familiarity with ICD/Pacemaker programming~     during the study. When imaging children who meet age and weight criteria, a physician will be~     present during the entire study. Fellow and attending radiology and electrophysiology support~     will be available in house in all cases.~      Standard device testing including battery voltages, thresholds, sensing and lead impedances~     will be measured.~   "
102400|NCT02226991|"~     Study to investigate the effects of steady-state Efavirenz (600 mg QD) on the steady-state~     pharmacokinetics of Tipranavir (500 mg BID) coadministered with Ritonavir (200 mg BID)~   "
102401|NCT02226978|"~     Assessment of the interaction of tipranavir/ritonavir (TPV/RTV) and valaciclovir (VAL), a~     prodrug of aciclovir (ACV)~   "
102402|NCT02226965|"~     This study is sponsored by Sierra Oncology, Inc. formerly ProNAi Therapeutics, Inc. It is a~     multi-center, nonrandomized, open label, phase II investigation of PNT2258 to characterize~     anti-tumor activity and collect safety data on patients with relapsed or refractory (r/r)~     diffuse large B-cell lymphoma.~   "
102403|NCT02226952|"~     Study to assess the antiviral efficacy, pharmacokinetics and tolerability of BILN 2061 ZW in~     a polyethyleneglycol 400 (PEG 400: ethanol) drinking solution given for two days bid in~     patients with chronic Hepatitis C Virus (HCV) infection.~   "
102404|NCT02226939|"~     Study to assess the antiviral efficacy, pharmacokinetics, and tolerability of 200 mg BILN~     2061 ZW in a polyethylene glycol 400 (PEG 400: ethanol) drinking solution given orally for~     two days bid to patients with cirrhosis and chronic Hepatitis C Virus (HCV) infection~   "
102405|NCT02226926|"~     Investigation of the mechanism of dipyridamole action in platelets in an in-vivo study with~     healthy volunteers treated Aggrenox in comparison with volunteers treated with Persantin~     Retard or Acetylsalicylic Acid using platelet Vasodilator-Stimulated-Phosphoprotein~     (VASP)-phosphorylation as indication for an action and measurements of dipyridamole plasma~     levels~   "
102406|NCT02226913|"~     Buffering of local anesthetics (alkalinization) has been suggested in achieving pain control.~     The purpose of this prospective, randomized, double-blind study was to evaluate the effect of~     adding 0.6 mL 8.4% sodium bicarbonate to 3.0 mL 2% lidocaine with 1: 80,000 epinephrine on~     the success rate of IAN block for endodontic treatment of mandibular molars with symptomatic~     irreversible pulpitis.~   "
102407|NCT02226900|"~     This is a pilot randomized study that aim to assess the safety and feasibility of a hybrid~     myocardial revascularization strategy (coronary artery by-pass graft and percutaneous~     intervention) in comparison with conventional surgical coronary bypass grafting.~   "
102408|NCT02226887|"~     Design Prospective , randomized, parallel phase IV.~      Objectives Main objective~        -  Evaluate the effectiveness of the placement of a resorbable mesh in the prevention of~          incisional hernia of the abdominal wall at the site of a loop ileostomy when it is~          closed  to rebuild the intestinal transit. The effectiveness evaluation is done by~          tracking with scheduled patient visits for 12 months, assessing the physical examination~          the presence or absence of an incisional hernia and an abdominal tomography at the end~          of the 12 months .~      Secondary objectives Comparison of complications(morbidity and mortality) to assess safety~     and tolerability of the placement of the mesh described .~   "
102409|NCT02226874|"~     Background:~      - The National Cancer Institute was funded to study how much radiation U.S. veterans who~     served in the 1950s were exposed to. Researchers want to estimate how much radiation these~     veterans received. They will use two methods and compare them. One is to interview the~     veterans and study their military records. The other is to take blood samples and look for~     certain types of changes in the blood cells. Being exposed to some kinds of radiation is~     known to cause changes in blood cells. The amount of changes to these cells tells scientists~     about how much radiation was received.~      Objectives:~      - To better understand how to measure how much radiation a person has received.~      Eligibility:~        -  Veterans who were exposed to radiation at a specific site in the Pacific in 1954 or~          other sites in the 1950s.~        -  Veterans close in age to the first group, who have low levels of exposure to radiation.~        -  Men about 25 years old with no exposure to radiation.~      Design:~        -  Participants will have 1 visit, in their home.~        -  All participants will have blood drawn. This will take 10 minutes.~        -  The exposed veterans will be interviewed. They will answer questions about the nuclear~          events they experienced. This will take up to 40 minutes.~        -  For the exposed veterans, researchers will look at their military records, if they can.~          They will estimate how much radiation the veteran received.~   "
102421|NCT02226718|"~     For measuring quality of life in patients with chronic inflammation of the middle ear, only~     two questionnaires currently exist. However, these questionnaires are designed only to~     measure either disease-specific health or hearing-related quality of life. The aim of this~     project is the validation of a pre-existing comprehensive questionnaire, which is routinely~     administered in the investigators clinic but has never been validated. Following a~     retrospective item reduction based on existing data, this questionnaire will be prospectively~     validated. Applying the resulting questionnaire in future studies on chronic middle ear~     inflammation, not only objective outcome parameters (e.g. audiograms) but also quality of~     life will be assessed. Therefore, the investigators questionnaire will add substantial~     information to these outcome studies by providing a subjective outcome parameter.~   "
102410|NCT02226861|"~     Background:~      - Stem cell transplantation from a partially matched donor can lead to graft-versus-host~     disease (GVHD). Researchers want to learn how to improve these transplantations.~      Objective:~      - To see if very low doses of Interleukin-2 after a partially matched transplantation prevent~     GVHD.~      Eligibility:~        -  Recipients: age 18 65, with certain bone marrow or lymphatic system diseases and an~          available family member with partial tissue match.~        -  Donors: age 18 80.~      Design:~        -  Recipients will be screened with medical history, physical exam, and many tests~          including blood and tissue tying.~        -  Donors will be screened with medical history, physical exam, blood tests and tissue~          typing.~        -  Recipients will stay in the hospital 3 6 weeks.~        -  All participants will have apheresis. Blood is drawn from one arm, run through a machine~          that collects white blood cells, then returned into the other arm.~        -  Recipients will have:~        -  Intravenous (IV) line placed under the skin and into a neck vein, to stay throughout~          transplant and recovery. They may also have a catheter inserted for collecting immune~          cells.~        -  Bone marrow sample taken by needle. They will have 3 more after transplant.~        -  Donors will have:~        -  Filgrastim injected once daily for 5 6 days.~        -  Stem and immune cells collected by another apheresis.~        -  Recipients will get:~        -  Eight 30-minute doses of radiation, sitting at a machine.~        -  Donor immune cells by IV, 6 days before the transplant day.~        -  Chemotherapy drugs by IV.~      <TAB><TAB>- Donor stem cells by IV on transplant day.~        -  After transplant, recipients will give self-injections of very low doses of~          Interleukin-2 once daily for about 12 weeks.~        -  Before and after transplant, recipients will get medicine to suppress the immune system~          and antibiotics to prevent infections~        -  Recipients must stay near NIH for 3 6 months after transplant.~        -  All recipients and donors will have 3 years of follow-up.~   "
102411|NCT02226848|"~     Background:~      - Traumatic brain injury (TBI) injures blood vessels in the brain. Endothelial progenitor~     cells (EPCs) help the body form new blood vessels. The drug erythropoietin (EPO) helps the~     body make more blood cells and might help make blood vessels. Researchers want to see if EPO~     helps people with TBI.~      Objective:~      - To see whether erythropoietin increases the number of endothelial progenitor cells~     circulating in the blood and changes reactivity of brain vessels.~      Eligibility:~      - Adults age 18 70 who had a TBI 3 7 days ago and still have symptoms.~      Design:~        -  Participants will be screened with medical history and blood tests. Vital signs will be~          taken.~        -  Visit 1:~        -  Medical history, physical exam, and blood sample.~        -  Neuropsychological tests of memory, attention, and thinking. These include written and~          spoken questions, tests on paper or computer, and simple actions.~        -  Magnetic resonance imaging (MRI) scan with carbon dioxide. Participants will lie on a~          table that slides in and out of a metal cylinder. For part of the scan, participants~          will wear a breathing mask like a snorkel and wear a nose clip.~        -  Study drug or placebo injection under the skin of the arm, leg, or buttock.~        -  Visits 2, 3, and 4 will be 1 week apart.~        -  Blood sample.~        -  Review of TBI symptoms and any drug side effects.~        -  Study drug or placebo injection under the skin.~        -  Visit 5 will be 1 week after visit 4. Visit 6 will be 6 months after participants start~          the study.~        -  Blood sample.~        -  Review of TBI symptoms and any drug side effects.~        -  Neuropsychological tests.~        -  MRI with carbon dioxide.~   "
102412|NCT02226835|"~     Background:~      - Alzheimer s disease affects the brain and causes memory and thinking problems in older~     people. Macular degeneration (MD) is an eye condition. It is the leading reason that people~     over age 55 in the United States lose their central vision. Central vision is important for~     seeing fine details and for tasks like reading and driving. A feature of Alzheimer s disease~     is plaques in the brain. A feature of age-related MD is deposits in the retina in the eye.~     Researchers want to learn more about these diseases and find out if they are related.~      Objective:~      - To see whether there is a relationship between Alzheimer s disease and age-related macular~     degeneration.~      Eligibility:~      - People with or without Alzheimer s disease enrolled in another study. Participants must~     have someone to help them take part in this study.~      Design:~        -  Participants will be screened through the other study. They will have 1 visit. The tests~          will take about 3 hours.~        -  Participants will answer questions about their medical and eye history.~        -  Participants will have an eye exam to test how well they see. Their eye pressure will be~          measured and their eye movements will be checked.~        -  Participants will get eye drops to dilate their pupils. Researchers will take pictures~          of the retina and the inside of the eye. Researchers may measure the thickness of the~          retina.~        -  Participants will continue to receive care from their regular eye doctor during and~          after the study.~   "
102413|NCT02226822|"~     This study is intended to prospectively research the treatment reality and long-term disease~     control of Type 2 Diabetes Mellitus (T2DM) patients who are initiating 2nd line anti-diabetes~     treatment in sites across Japan.~   "
102414|NCT02226809|"~     Residual neuromuscular block (RNMB) is frequent in the immediate postoperative period and is~     a source of complications, mainly respiratory. The incidence is variable due to multiple~     factors. In Spain the incidence is unknown.~      The investigators hypothesize that a number of patients in the postanesthesia care unit~     (PACU) present with RNMB after general anesthesia using intermediate action neuromuscular~     block agents (NMBA).~      The main objective is to know the incidence of RNMB in Spanish hospitals. Secondary~     objectives are to observe the possible relationship with other pre- and intraoperative~     factors.~   "
102415|NCT02226796|"~     We hypothesize patients who have difficulty with word recall (naming pictures) due to a~     stroke will experience greater benefit in word recall after receiving a combination of~     transcranial direct current stimulation (tDCS) and traditional behavioral treatment. This~     study will investigate the effects of the timing of tDCS in relationship to the behavioral~     treatment to determine the most optimal protocol. Transcranial direct current stimulation~     involves placing two electrodes on your scalp and sending a very small electrical current to~     excite the brain cells of the target site.~   "
102416|NCT02226783|"~     Study to evaluate the effect of intake of food in comparison to fasting condition on~     pharmacodynamics of AZD1722 following a twice-daily administration of AZD1722 tablet~     formulation~   "
102417|NCT02226770|"~     The aim of the present study is to measure heart-focused anxiety, general anxiety,~     depression, PTSD and quality of life as well as type D personality in patients with heart~     failure before and after the implantation of a cardioverter defibrillator (ICD) and/or assist~     device (AD).~   "
102418|NCT02226757|"~     This study is a pilot study in EGFR-mutated NSCLC patients who have progressed on~     standard-dose TKIs. Tumor biopsies will be evaluated for HER2-expression. In case of HER2~     expression, patients can participate in the trial after obtaining informed consent.~      Patients will be treated with weekly paclitaxel-trastuzumab.~   "
102419|NCT02226744|"~     Mind-body practices, such as yoga, ta'i chi, mindfulness and biofeedback, commonly use slow~     breathing techniques to induce physiological and mental relaxation. Medical research suggests~     that slow breathing techniques induce physiological relaxation. This 6 week study will~     compare the effects of different types of breathing. The hypothesis is that different~     breathing techniques produce different physiological and mental changes.~   "
102422|NCT02226705|"~     Radical endoscopic transnasal surgery associated with medical treatment with liposomal~     amphotericine B may increase the local control of Rhino-Sinusal Mucormycosis and the survival~     rate. The objective of this study is to evaluate the local control rate and survival rate at~     3 months after radical endoscopic transnasal surgery extended towards the skull base in~     association with antifungal therapy and early surgical reevaluation of the extent of the~     disease.~   "
102423|NCT02226692|"~     The aim of the present study is to quantify the relative contribution of variables obtained~     during a physical fitness evaluation and a short screening questionnaire in determining the~     short-term and long term risk of persistent disabling low back pain in patients with chronic~     low back pain. It has been hypothesized that patients with higher physical fitness will~     present a lower risk of persistent disabling low back pain and so, a lower score on the~     questionnaire.~   "
102424|NCT02226679|"~     The objective of this extension study is to evaluate the safety and potential beneficial~     effects of the Algisyl-LVR™ device in patients with established heart failure secondary to a~     dilated cardiomyopathy. The results of this study will provide confirmatory evidence of the~     long-term safety and effectiveness of the Algisyl-LVR in patients with established heart~     failure.~   "
102425|NCT02226666|"~     The purpose of this study is to prospectively compare the physiologic response of patients~     who receive either intravenous gadoxetic acid (Eovist) or intravenous gadobenate dimeglumine~     (MultiHance).~   "
102426|NCT02226653|"~     The purpose of this study is to determine if two different dosing strategies for evacetrapib~     will have essentially the same effect on the body. The study will also explore the effect of~     a low fat meal on how the body absorbs evacetrapib. This study will last at least 15 weeks,~     not including screening. Screening is required within 28 days prior to the date of first~     dosing.~   "
102427|NCT02226640|"~     This is a study to identify different subtypes of type 2 diabetes. The investigators will~     look for information at the molecular level, which may lead to personalized diagnosis and~     therapies.~   "
102428|NCT02226627|"~     This study aims to make a proper scientific assessment on the dietary intake and physical~     activity levels of a representative sample of the urban population of 8 Latin American~     countries (Argentina, Brazil, Chile, Colombia, Costa Rica, Ecuador, Perú and Venezuela). The~     study was based on complex, multistage sample design, stratified by conglomerates, being all~     regions of each country represented, and random selection of main cities within each region~     according to probability proportional to size method. Sample will be stratified by gender,~     age (15 to 65 years old), and socioeconomic level. Socioeconomic levels will be balanced and~     divided in three strata (high, medium and low) based on national indexes used in each~     country. All the study sites are university-based and will adhere to a common study protocol~     for training, implementation of fieldwork, data collection and management, and quality~     control procedures to be performed simultaneously. All participants will be required to~     provide a written informed consent. A pilot study at small scale will be performed in each~     country in order to test procedures and tools involved in ELANS. Anthropometric variables,~     including body weight, height, waist, hip and neck circumferences will be measured according~     to a standardized protocol. Nutritional intake evaluation will be performed using two 24-hour~     dietary recalls, with 'multiple pass' procedure and a food frequency questionnaire.~     Nutritional data will be entered in Nutrition Data System for Research (NDS-R, Minnesota~     University) after a harmonization process between local foods and NDSR database. Physical~     activity and energy expenditure will be assessed by IPAQ-long version questionnaire and 7-day~     accelerometry.~   "
102429|NCT02226614|"~     This study is testing a head-cooling device on volunteers to assess temperature reduction.~   "
102430|NCT02226601|"~     Morphine and similar substances (called opioids) are often prescribed for moderate to severe~     pain, such as after a surgery, thus allowing for minimal pain and a better recovery.~     Unfortunately various, non-dangerous side effects from opioids occur often that limit the way~     patients feel and can take of themselves, despite otherwise good pain control and minimal~     limitations from the surgery itself.~   "
102431|NCT02226588|"~     The objective of this study is to compare two community-level strategies: either selective,~     early administration of 800 mcg sublingual misoprostol to women for secondary prevention of~     postpartum hemorrhage (PPH) or universal use of 600 mcg oral misoprostol at the time of~     delivery for prophylaxis of PPH. The significance of this cluster randomized non-inferiority~     trial is its potential to inform service delivery programs on clinical outcomes, program~     feasibility, cost, and acceptability of two different community models of PPH care using~     misoprostol.1. The study hypothesizes that a service delivery model that administers~     misoprostol for secondary prevention is non-inferior to a model that administers misoprostol~     for universal prophylaxis.~   "
102432|NCT02226575|"~     The purpose of this study is to evaluate the effect of a cognitive behavior therapy distress~     management program targeting wellbeing in patients with atrial fibrillation and their~     relatives.~   "
102433|NCT02226562|"~     The aim of this study is to investigate the longitudinal efficacy of a potassium nitrate~     mouthwash formulation when used as an adjunct to brushing with a standard fluoride dentifrice~     for the relief of dentinal hypersensitivity (DH) compared to brushing with a standard~     fluoride dentifrice alone. This will be a single centre, eight week, randomised, examiner~     blind, two treatment arm, parallel design, stratified (by maximum baseline Schiff Sensitivity~     Score of the two selected test teeth) study in participants with at least two sensitive teeth~     that meet all the criteria at the Screening and Baseline visit. Participants will be assessed~     at Baseline, and at four and eight weeks to monitor clinical efficacy and safety.~   "
102434|NCT02226549|"~     This study is to evaluate the antiviral efficacy, safety, and tolerability of combination~     therapy with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) + vedroprevir (VDV)~     ± ribavirin (RBV) for 8 weeks in treatment-experienced adults with chronic genotype 1~     hepatitis C virus (HCV) infection and cirrhosis.~   "
102443|NCT02226432|"~     The objective of the present trial is to demonstrate Magnetic stimulation as an useful~     complementary treatment in order to improve patients' evolution without the need of extensive~     surgical lesion.~   "
102645|NCT02223806|"~     To determine whether there is a difference in effectiveness of routine uterine tonus~     assessment (every 15 minutes, for 2 hours) when performed by a midwife or self-administered~     by a patient on the incidence of postpartum haemorrhage, mean blood loss, and other maternal~     and neonatal outcomes.~   "
102435|NCT02226536|"~     Introduction: the global sugar consumption has increased in the past 50 years and their~     abusive intake is responsible for the insulin resistance and causes the metabolic syndrome -~     obesity, diabetes mellitus, hypertension and coronary heart disease. Objective: To evaluate~     the effect of scheduled diet without glucose as treatment of labyrinthine disorders~     associated with glucose-insulin index. Study Design: A prospective randomized controlled~     trial. Patients and Methods: A study conducted at the University of São Paulo with 51~     patients divided into two groups: Diet Group (DG) that comprises subjects treated with~     fractionated diet with glucose restriction and control group (CG) where individuals were not~     counseled regarding diet. Patients underwent computerized dynamic posturography - sensory~     organization test (CDP - SOT) and Visual Analog Scale (VAS) in the first and thirtieth days~     of the study.~   "
102436|NCT02226523|"~     To improve the sensitivity and specificity of immunoassay, the developing trends are to lower~     the detection threshold and to minimize the cross reaction. A new assay technology called~     immunomagnetic reduction (IMR) has been developed for rapid and on-site assay with small~     volume of sample. Rapid diagnosis of acute coronary syndrome (ACS) is a clinical and~     operational priority in busy emergency departments (ED), early and correct diagnosis is~     important. Cardiac enzymes (including CPK/CK-MB, troponins, myoglobulin) and~     electrocardiography (ECG) in combination with the medical history and physical examination~     are at present the diagnostic cornerstones. Novel biomarkers that rise earlier, have good~     diagnosis accuracy and have additional prognostic information are highly needed. The~     combination of multiple biomarker assays (markers of myocardial injury, inflammation/plaque~     ruptures or heart failure with different mechanism) may increase clinical sensitivity and~     improve early risk stratification. The present study, a rapid IMR assay with multiple~     biomarkers is proposed and we will examine the performance of this new investigational IMR~     assays, comparison with current commercial assays.~   "
102437|NCT02226510|"~     Thickening of the heart muscle (left ventricle) known medically as Left Ventricular~     Hypertrophy (LVH) is very common in patients with heart disease. This increases risk of~     cerebrovascular/cardiovascular event.~      LVH is asymptomatic and managed by the use of medication to control blood pressure, however~     LVH may be seen in normotensive patients where factors such as obesity and insulin resistance~     are present.~      Insulin resistance is a condition where although the body produces insulin it is unable to~     utilize it effectively. Metformin, a drug used to treat diabetes, can reduce insulin~     resistance and cause weight loss, it may therefore improve LVH. This study will investigate~     the ability of metformin to reduce LVH in patients with heart disease, this may be a novel~     way forward in the risk reduction of cerebrovascular/cardiovascular events. Participants will~     be identified throughout NHS Tayside, those eligible will be randomly allocated to either~     metformin or a dummy medication (placebo) and will receive one year of treatment. At the~     beginning of the study, the thickness of the heart muscle will be measured by ultrasound scan~     and cardiac Magnetic Resonance Imaging (cMRI). We will also perform non-invasive tests to~     measure blood vessel function. These tests will be repeated after one year. At the end of the~     study, we will investigate the difference between placebo treatment and metformin treatment.~      This study is funded by the British Heart Foundation.~   "
102438|NCT02226497|"~     This randomized pilot clinical trial studies a home telemonitoring device in managing the~     care of patients with myelodysplastic syndrome or acute myeloid leukemia after they are~     discharged from the hospital following chemotherapy. After treatment and hospital discharge,~     patients typically need extensive care to deal with the side effects of chemotherapy, keep up~     with medications, and obtain medical assistance. A home telemonitoring device would allow~     patients to monitor vital signs, symptoms, and use of medications, communicate with~     healthcare providers, and access educational material. A telemonitoring device may allow~     patients to be managed more effectively than standard outpatient care after being discharged~     from the hospital.~   "
102439|NCT02226484|"~     Purpose:~        1. Determine if oral quercetin increases the expression of claudin-4 in the lining of the~          esophagus of patients with a diagnosis of gastroesophageal reflux disease (GERD); and~        2. Determine whether the increase in claudin-4 by oral quercetin is accompanied by~          improvement in the barrier function and acid resistance of the lining of the esophagus~          of patients with a diagnosis of gastroesophageal reflux disease (GERD)~      If interested, participants will be consented and provided a questionnaire to complete as~     part of the study. Participants will undergo endoscopy for routine care and will have up to 8~     esophageal biopsies (small tissue samples) taken for the research study. After endoscopy,~     participants will be contacted to begin a 6 week treatment period with study drug (Quercetin,~     taken twice daily).~      At the end of the 6 week period, participants will be scheduled to have blood drawn and to~     have a follow-up endoscopy with biopsies performed for the research study.~   "
102440|NCT02226471|"~     Insulin resistance is closely correlated with obesity and cardiovascular disease. Adipokines~     may play important roles in the pathogenesis of obesity, which are a link between obesity and~     obesity-related disorders.C1q/TNF-related protein-3 (CTRP3) and retinol-binding protein 4~     (RBP4) are novel adipokine that modulates the action of insulin in various diseases. This~     study addressed the relationship between CTRP3, RBP4 and IR in newly diagnosed obesity and~     essential hypertension.~   "
102441|NCT02226458|"~     The investigators hypothesize that EPI-743 may provide clinical benefit to children with~     Autism Spectrum Disorder.~   "
102442|NCT02226445|"~     The investigators knowledge of factors associated with treatment drop-out and missed~     appointments among adults with Attention-Deficit/Hyperactivity Disorder (ADHD) within a~     naturalistic, clinical setting is very limited. Drop-out rates among adult ADHD patients in~     randomised controlled trials (RCT´s) have been reported to be 26.6% - 50%, and similar rates~     are reported in two naturalistic studies of medication adherence.~      Based on proposed hypotheses that past behaviour patterns are more predictive of current~     behaviours of treatment drop-out and missed appointments than are sociodemographic and~     clinical characteristics, the aim of the present study is to examine the associations of 1)~     sociodemographic variables, 2) clinical variables, 3) risk-taking behaviour 4) educational~     and occupational instability and 5) behaviours during primary/lower secondary school with~     treatment drop-out and number of missed appointments.~      The target group of the study consists of all patients who initiates assessment at the adult~     ADHD Clinic at Regional Psychiatric Services West, Herning, Central Denmark Region in the~     period from September 1, 2010 to September 1, 2011. The patients are referred to this Clinic~     from general practitioners and specialised psychiatric authorities. The investigators study~     is designed as an observational, cohort study in which the patients are offered medical and~     non-manualised psychosocial treatment as it is usually offered in this tertiary ADHD Clinic~     from which the data are collected.~      Data regarding sociodemography, clinical symptoms and impairments, risk-taking behaviour,~     educational and occupational instability and behaviours during primary/lower secondary school~     are collected using a semistructured protocol.~      In the investigators study the investigators define treatment drop-out as premature~     termination of ongoing treatment, without any prior clinical or agreed resolution. No~     standardized definition of treatment drop-out is used through out the literature of adherence~     to treatment among patients in the psychiatric care system.~   "
102444|NCT02226419|"~     The investigators wish to investigate fat and sugar metabolism during exercise with and~     without L-carnitine supplementation in patients with carnitine transporter deficiency (CTD).~      Patients with CTD have low plasma- and muscle concentrations of carnitine, which is believed~     to lead to an impaired fat oxidation. Presently there is no cure available for these~     patients, but daily intake of L-carnitine has been shown to limit the amount of symptoms.~     Little is known about the metabolism during exercise and the pathophysiological mechanisms~     causing the symptoms.~      Studying the fat and sugar metabolism in CTD patients will contribute to the understanding of~     the role of the carnitine transporter in the development of symptoms in these patients.~     Furthermore, knowledge about the fat and sugar metabolism in these patients can increase the~     understanding of the role of the carnitine transporter in the metabolism healthy persons.~      The investigators have included 8 patients with genetically verified CTD in the study and a~     group of 10 age- and sex-matched controls. Subjects will perform a 1h cycling test,~     exercising at a moderate intensity. By measuring the expiration of carbon dioxide (CO2) and~     consumption of oxygen (O2), the investigators can determine the total fatty acid and~     carbohydrate oxidation during cycling. At the same time the investigators will measure the~     patients' whole body palmitate (fat) and glucose (sugar) oxidation rates using stable isotope~     technique.~      The patient group will repeat the cycling test after 4 days without taking their usual~     L-carnitine treatment. During the treatment break, patients will be admitted to be~     continuously monitored for heart rhythm disturbances, which is a known but rarely occurring~     complication to untreated CTD.~      Since the patients have a defect in their fat metabolism, the investigators expect to find~     that they have a reduced ability to burn fat, which is the major source of energy during low~     intensity exercise. It is therefore likely, that the CTD patients will benefit from~     adjustments in their daily diet, whenever they have to perform physically. By learning about~     the metabolism of different dietary substances, fat and sugar, these studies can help to~     improve the treatment in terms of dietary recommendations for CTD patients. This will have a~     direct impact on the daily life of the patients.~   "
102445|NCT02226406|"~     In the critically patient bed rest and immobilization are some of the responsable of the~     development of respiratory complications. Early physical exercise is a tool to prevent~     respiratory complications as lost of respiratory muscle strength, decrease in functional~     residual capacity and hypoxemia improving oxygenation.~      New technology as electrical impedance tomography (EIT) are available to visualize changes of~     regional lung aeration.~      The aim of this study is to assess the effect of early physical exercise improving alveolar~     recruitment and pulmonary ventilation in intensive care unit (ICU) patients, evaluated with~     EIT.~      The ICU patients included at day of evaluation will be evaluated continuously with EIT in~     different positions. 1) in the supine position (at 30° of inclination), 2) Sitting in chair~     3) Active physical exercise 4) And rest in chair after exercise~   "
102446|NCT02226393|"~     Traumatic events have potentially debilitating long-lasting effects on the child's normal~     development and, therefore, should be effectively treated. Prolonged Exposure (PE) therapy~     has been found to be effective in reducing posttraumatic stress disorder symptoms in adults~     and in adolescents. It has not yet been tested in toddlers.~      The purpose of this study is to examine the treatment efficacy of 2 methods of treatment for~     toddlers with PTSD and their parents. A randomized control trial could examine the efficacy~     of PE versus dyadic play therapy (TP-CT). Exploration of these questions under more rigorous~     conditions would help broaden our knowledge about developmentally sensitive treatment tools~     for this age group.~      Our research hypotheses are:~        1. PE would more effective than TP-CT in reducing post-traumatic symptoms in toddlers.~        2. PE would more effective than TP-CT in reducing post-traumatic symptoms of the toddlers'~          parents.~        3. These results will be preserved in a follow-up of 3-6 months post treatment. Following~          psychiatric assessment, 100 toddlers will be randomly assigned to PE and TP-CT (50~          participants in each group).~   "
102447|NCT02226380|"~     Purpose: This aim of the study is to evaluate the efficacy and safety of neoadjuvant~     chemotherapy with the modified FOLFOX6(mFOLFOX6) regimen and its impact on survival on a~     series in local advanced gastric cancer patients.~      Patients and methods: The study is a prospective non-randomized study. Patients with~     histopathologically confirmed and locally advanced gastric cancer(T2-T4 or N+) are enrolled~     in the study. Patients are given mFOLFOX6 scheme for 3 cycles.A radical gastrectomy and a D2~     lymphadenectomy was will be scheduled 3-6 weeks after the completion of the preoperative~     chemotherapy. Down-staging is assessed comparing pretreatment clinical staging with~     postoperative pathologic staging on patients who underwent radical surgery. Tumor~     down-staging and the grade of pathologic response are included in a statistical correlation~     between tumor regression induced by mFOLFOX6 neoadjuvant chemotherapy and survival.The~     primary endpoint is 3-year overall survival, secondary endpoints are disease-free survival,~     R0 resection rate, toxicity and prediction of response.~   "
102448|NCT02226367|"~     The purpose of the study is to evaluate if the drug prazosin:~        -  will decrease alcohol use in active duty members of the military who served in Iraq~          and/or Afghanistan and~        -  determine if presence or absence of posttraumatic stress disorder affects treatment.~   "
102449|NCT02226354|"~     Seeds from the Buglossoides arvensis plant (trademarked as Ahiflower™) produce oil that is a~     rich natural source (20%) of stearidonic acid (SDA), a metabolic intermediate between omega-3~     fatty acids found in other plants (such as flax) and those found in fish oils.~      The objectives of this study to collect safety data and to investigate the accumulation of~     long chain n-3 polyunsaturated fatty acids in human lipids following oral supplementation~     with Ahiflower oil in healthy adults.~   "
102450|NCT02226341|"~     Systemic Lupus Erythematosus (SLE) is a disease in which the immune system attacks the~     healthy cells and tissues, causing inflammation that can damage organs in the body. About 50%~     of SLE patients experience inflammation in the kidneys. The purpose of this study is to~     determine the effectiveness and safety of two dosing arms of ACTHar gel in treating~     proliferative Lupus Nephritis (LN). This study hypothesizes that both dosing arms of ACTHar~     are safe and effective in treating proliferative LN (Class III and IV).~   "
102451|NCT02226328|"~     Flexible bronchoscopy almost always requires sedation to be successful. In order to increase~     the availability of propofol for sedation, non-anaesthesiologist administered propofol~     sedation has been suggested as an alternative to traditional midazolam/opioid sedation or the~     general anaesthesia provided by anaesthesiologists.~      Hypothesis: Patients undergoing flexible bronchoscopy prefers non-anaesthesiologist~     administered sedation with propofol as opposed to non-anaesthesiologist administered sedation~     with midazolam and fentanyl.~      Propofol sedation is as safe as midazolam and fentanyl sedation.~   "
102452|NCT02226315|"~     This study will evaluate the clinical performance of massively parallel sequencing (MPS)~     using the MaterniT21 PLUS LDT in the detection of fetal aneuploidy in circulating cfDNA~     extracted from a maternal blood sample obtained from women pregnant with a multiple gestation~     who were at increased risk for fetal aneuploidy.~   "
102453|NCT02226302|"~     The objective is to develop an organotypic model to assess the effects of obesity on the~     expression and methylation status of estrogen-responsive genes in endometrial cancer. Omental~     fat samples will be removed from participants during surgery and these fat samples will be~     used in laboratory analyses.~   "
102454|NCT02226289|"~     Bevacizumab, a humanized monoclonal antibody against vascular endothelial growth factor~     (VEGF), combined with fluoropyrimidine-based chemotherapy is now the standard first and~     second-line treatment for metastatic colorectal cancer. The efficacy of bevacizumab with~     cytotoxic agents in the third-line treatment of patients with mCRC is still unknown.~   "
102455|NCT02226276|"~     This pilot clinical trial studies how well copper Cu 64-tetra-azacyclododecanetetra-acetic~     acid (DOTA)-trastuzumab positron emission tomography (PET) works in predicting response to~     treatment with ado-trastuzumab emtansine in patients with human epidermal growth factor~     receptor 2 (HER2) positive breast cancer that has spread to other places in the body. Copper~     Cu 64-DOTA-trastuzumab is a chemotherapy drug (trastuzumab) attached to a radioactive~     substance. Diagnostic procedures using PET may allow scanners to take pictures of where the~     drug travels in the body and may help doctors identify which patients may benefit from~     treatment with ado-trastuzumab emtansine.~   "
102456|NCT02226263|"~     The purpose of this study is to know the effects of probiotics on the incidence of~     Necrotizing Enterocolitis (NEC) in preterm infants less than 1500 g.~   "
102457|NCT02226250|"~     Primary objective is to determine absorption profile of a sugar-based beverage on~     inflammatory mechanism by timing of beverage consumption relative to meal intake.~      Secondary objective is to determine absorption profile of a sugar-based beverage on oxidative~     and metabolic mechanism by timing of beverage consumption relative to meal intake.~      The results will be served as an internal reference or negative control group to compare with~     polyphenol containing studies from other studies.~      Each subject will receive 3 identical placebo drinks at each time points: fasting (0h), with~     standardized breakfast meal (2h), and 2 hours after the breakfast meal (4h). A planned size~     of 12 will be recruited into this part of the study.~      This study is a single-arm design utilizing a multiple sampling, and repeated measures~     paradigm to evaluate timing influence of consumption of sugar-based beverage associated acute~     effect on inflammatory markers.~   "
102458|NCT02226237|"~     The prostate cancer is the most common parenchymal neoplasia in men over 45 years old.~     Radical prostatectomy is curative treatment is most used today. Urinary incontinence and~     erectile dysfunction are the main complications of radical prostatectomy. Physical therapy~     has been used as a form of conservative treatment of these complications. However, the role~     of physiotherapy in the treatment of these complications is not well defined in the~     literature. We will do a randomized controlled study with patients undergoing radical~     prostatectomy. After removal of the Foley catheter, patients will be randomized into 3~     groups: control group, group of pelvic floor exercises and anal electrostimulation group.~     These patients will be evaluated preoperatively in an attempt to meet prognostic factors for~     urinary incontinence and erectile dysfunction. They will be followed by 2 years after~     surgery, to assess whether the therapy will alter the course of urinary continence and~     erectile function in these patients.~   "
102459|NCT02226224|"~     In our era of personalized treatment, both the prognosis and the choice of therapy for upper~     GI malignancies depend on the staging before any treatment. Most experts recommend EUS~     (Endoscopic Ultrasound) as the first line for T-staging but the diagnostic accuracy in~     clinical practice varies in different centers according to the published data. Neither the~     discrepancy between EUS and histological findings nor the variation between centers well~     explained. So the investigators designed this prospective study. In the present study, the~     investigators performed EUS on the resected specimen after surgery before fixation in~     formalin, evaluated the invasion of the GI wall, and marked the deepest location with~     sutures. And try to determine the exact accuracy of EUS staging , find the discrepancy~     between EUS and histologic findings.~   "
102460|NCT02226211|"~     Supraglottic airway devices (SGA) become a routine part of the daily anesthesia practice.~     they can be used as primary airway devices or as conduits for endoracheal intubation and they~     become an integral part in the recent guidelines for managing difficult airway.~      Air-Q ILA has been used successfully as 1ry airway and also as a conduits for endotracheal~     intubation.~      The Ambu® Aura-i TM laryngeal mask is a new disposable SGA claimed to have special advantage~     over the competitors but not will studied as a conduit for endoracheal intubation.~      This study is designed to compare the performance of Ambu®Aura-i™ laryngeal mask with the~     air-Q ILA as conduits for fiberoptic-guided tracheal intubation in adult population.~   "
102461|NCT02226198|"~     The purpose of the study is to establish the efficacy, safety and tolerability of~     rosuvastatin in children and adolescents with homozygous familial hypercholesterolemia.~   "
102462|NCT02226185|"~     Berberine hydrochloride is a conventional component in Chinese medicine. In recent years,~     anticancer activity of berberine hydrochloride have been explored. The aim of this study is~     to investigate the effect of berberine hydrochloride on the recurrence of colorectal~     adenomas.~   "
102463|NCT02226172|"~     A lead-in cohort of ~20 patients with primary or secondary myelofibrosis previously treated~     with 1 or more Janus kinase inhibitors enrolled to single-agent glasdegib to evaluate safety~     and tolerability. Following the lead-in, a phase 2, double blind, 2-arm study, randomized 2:1~     to oral single-agent glasdegib versus placebo in 201 patients resistant or intolerant to~     ruxolitinib.~   "
102464|NCT02226159|"~     Cervical radicular pain is a common cause of disability and pain in the upper extremity and~     neck with an annual incidence of 83.2/100,000 (1). The initial treatment is conservative and~     includes relative rest, use of anti-inflammatory and analgesic medication, as well as~     physical therapy and home exercise. For patients who have persistent and significant~     symptoms, interventional pain management and surgical management are considered. Cervical~     epidural injections are the mainstay of the interventional, non-surgical modalities. They can~     be considered to provide short and long-term relief when disc herniation, foraminal stenosis~     or central canal stenosis pathology is identified. We are not aware of any published~     prospective, randomized, controlled, double-blinded studies demonstrating the efficacy of~     cervical transforaminal epidural steroid injections. However, the North American Spine~     Society (NASS) Review and Recommendation Statement states that based on the literature and~     expert opinion, a minimum of one or two cervical epidural steroid injections would be very~     appropriate in the treatment of a specific episode of cervical radicular pain.~      The purpose of this study is to determine the effectiveness of cervical transforaminal~     epidural steroid injections in decreasing the need for an operation in patients with cervical~     radicular pain, otherwise considered to be operative candidates.~   "
102465|NCT02226146|"~     This is an open-label, proof-of-concept, single group study in adult patients with newly~     diagnosed, moderate to extensive BP.~      The study will consist of three periods: a screening period of up to 2 weeks, an open-label~     treatment period lasting 4 weeks consisting of IV infusion of bertilimumab on Days 0 and 14~     and 28, and a safety and efficacy follow-up period of approximately 13 weeks.~      Patients will receive concomitant oral steroids during the treatment and follow-up period.~   "
102466|NCT02226133|"~     Exclusion of the LAA(Left Atrial Appendage) using the TigerPaw II System with VATS technique~     is safe and effective.~   "
102467|NCT02226120|"~     The purpose of this study is to collect safety and tolerability data on LCZ696 in eligible~     PARADIGM-HF patients receiving open-label investigational drug.~   "
102468|NCT02226107|"~     Disparities among racial and ethnic minorities remain prevalent despite advances in medical~     science that make thes early detection and prevention of colorectal cancer a possibility for~     all human kind. It is estimated that 90% of colorectal cancer deaths could be prevented~     through screening. Unfortunately, among Latinos, colorectal cancer is the second leading~     cause of cancer death. This rate is influenced by the fact that Latinos have the lowest rates~     of colorectal cancer screening compared to other US racial groups. Moreover, Latinos are more~     likely than whites to be diagnosed with advanced-stage colorectal cancer, when treatment~     options are more limited. Lay health worker interventions for breast and cervical cancer~     education and screening have demonstrated success in increasing both knowledge and screening~     rates among racial and ethnic minorities. Additionally, our research has also shown success~     in training African Americans as peer navigators to increase colorectal cancer screening. Few~     lay health interventions, however, have been designed specifically for colorectal cancer~     screening among Latinos. Thus, the purpose of this study is to expand peer navigation for~     colorectal cancer screening to Latinos and increase their participation in screening by~     training Latinos, who have had a colonoscopy, to help navigate other Latinos through the~     colonoscopy screening procedure.~      This study will focus on expanding the work of our research group by training Latino peers,~     who are 50 years or older, have had a colonoscopy, and can model successful colonoscopy~     screening completion to navigate Latino patients for screening. First, a training manual will~     be developed which will be culturally specific to Latinos. Feedback and input from community~     members will guide the development of the manual and training program. Second, the training~     program will be carried out with six bilingual Latino peers, who will be taught to master the~     core skills of patient navigation for screening colonoscopy. Finally, we will gather~     preliminary information about the trained peers' ability to successfully navigate patients~     for colonoscopy screening. If successful, this training program has the potential to increase~     colonoscopy screening rates of Latinos and will be critical to the development of future~     large-scale in interventions aimed at reducing advanced stage diagnosis of colorectal cancer~     and ultimately colorectal cancer deaths among Latinos.~   "
102469|NCT02226094|"~     The primary purpose of this study is to investigate the safety and efficacy of bilateral DWT~     in subjects with POAG or OHT compared to active and sham controls. The secondary purpose of~     the study is to investigate the durability, repeatability, and does response of the same.~   "
102470|NCT02226081|"~     We aim to determine if adding ShearWave Elastography to a standard ultrasound breast exam can~     improve the characterization (classification) of breast lesions.~   "
102471|NCT02226068|"~     Severe atopic dermatitis (AD) is a recurrent and debilitating disease often requiring~     systemic immunosuppressive treatment. The efficacy of cyclosporine A (CsA) is well proven but~     potential side effects are concerning. Several reports point at extracorporeal photopheresis~     (ECP) as an efficient alternative treatment modality with few and mild side effects. However,~     no direct comparison between CsA and ECP in the treatment of AD has been performed so far. In~     this trial we test the hypothesis that ECP is non-inferior to standard treatment with CsA.~   "
102472|NCT02226055|"~     1. We hypothesise that CKDu patients will have increased arterial stiffness and thus~          increased all-cause and cardiovascular mortality. The first objective of this study is~          to recruit a cohort of ~ 50 CKDu patients who attend the CKDu clinic in Anuradhapura,~          and measure their arterial stiffness using the TensioMed® Arteriograph™ (details below).~          We will recruit an age, sex and blood pressure matched control group of healthy Sri~          Lankans (consenting visitors with patients both to clinic and as inpatients), and if~          possible, a second control group, similarly age, sex and blood pressure matched, who~          have CKD of known causes and attend general renal clinic in Anuradhapura.~        2. We hypothesise that detailed renal analysis will give insight into the aetiology of CKDu~          in the North Central Province of Sri Lanka. The second objective of the study is to~          recruit up to 250 CKDu patients and to characterize their disease profile using analysis~          serum and urine renal biomarkers, exosomes, proteomics and DNA adducts.~   "
102473|NCT02226042|"~     This research will investigate the neuropsychological mechanisms underlying the eight-week~     Mindfulness-based Cognitive Therapy (MBCT) programme.~      Participants in remission from depression will be seen pre- and post-MBCT to assess the~     underlying neuropsychological mechanisms. All will be followed-up over 12 months to assess~     the relationship of these neuropsychological changes with relapse risk.~      The research will focus primarily on changes in self-compassion, rumination, attention and~     structural brain changes, with secondary focus on other mechanisms of emotional processing~     and memory.~   "
102474|NCT02226029|"~     Quantitative MR methods will be validated for the non-invasive imaging of GI processing of~     lipid emulsions in 18 (12+6) healthy subjects. Validation is performed by a randomized single~     blind two-armed crossover trial with two isovolumetric and isocaloric lipid emulsions of~     different microstructural properties. Hypotheses of this sudy are that~        1. the fat fraction of lipid emulsions in the GI tract can be monitored by quantitative MR~          methods and that 13C-sodium octanoate and~        2. 13C-sodium acetate in lipid emulsions will exhibit different excretion profiles due to~          their opposing binding affinity to water and fat.~   "
102475|NCT02226016|"~     The purpose of this study is to assess a new technique of measurement for the levator muscle.~      this measurement may be applied during a clinical evaluation of eyelid malposition.~      our purpose is to quantify the levator muscle strength and to corelate it to standard levator~     muscle strength assessment techniques routinley used in the oculoplastic clinic.~   "
102476|NCT02226003|"~     This is a study to evaluate the efficacy and safety of ertugliflozin (MK-8835/PF-04971729) in~     combination with sitagliptin in the treatment of participants with Type 2 diabetes mellitus~     (T2DM) with inadequate glycemic control on diet and exercise. The primary hypothesis of the~     study is that ertugliflozin plus sitagliptin is more effective in lowering of hemoglobin A1C~     (HbA1C) than placebo.~   "
102477|NCT02225990|"~     The purpose of this research study is to implement into clinical practice, the comprehensive~     QualPro protocol for stroke survivors, which includes gait coordination, balance, mobility,~     and fitness training. Feasibility will be tested in the clinical environment by providing the~     intervention, measuring patient outcomes, and identifying the obstacles to insurance payment~     for the QualPro intervention. By productively addressing issues of implementation, the~     hypotheses of this study include proven feasibility in the clinical environment and~     clinically significant gains for stroke patients in the areas of strength, balance, gait~     coordination, endurance, physical function, and increased life role participation.~   "
102478|NCT02225977|"~     In this study we wish to test the hypothesis that continuous Gilenya treatment alters immune~     homeostasis in favor of an anti-inflammatory type II monocyte and macrophage (M2) phenotype~     in the circulation of patients with relapsing-remitting Multiple Sclerosis (MS). In this~     study we will determine the change in ratio of M2 (type II, alternatively activated) versus~     M1 (type I, classically activated) monocytes and macrophages in a cohort of patients that~     have received continuous Gilenya treatment for 0, 1, 3, 6 or 12 months. We will also assess~     changes in cell surface expression of the M1 marker CCR7 and the M2 markers CD206 or CD301 by~     monocytes and macrophages using FACS analysis of whole blood, and assess the tyrosine~     phosphorylation of the signal transducer and activator of transcription STAT-1 (pTyr-STAT1),~     which is critical for the activation of M1 myeloid cells. We will assess correlates with~     changes in M1 and M2 cytokine expression assessing possible mechanisms of action of Gilenya~     on myeloid lineage cells.~   "
102479|NCT02225964|"~     This study is to find out the imaging marker and the changing laws of the marker during the~     course of the disease. The final purpose is to provide scientific evidence for new~     prevention, diagnosis and treatment of Alzheimer's disease.~   "
102480|NCT02225951|"~     This study is initiated to investigate the effect of a nutritional product on the 3-hr~     postprandial glucose response compared to a control standard breakfast at baseline and after~     4 weeks of intervention.~   "
102481|NCT02225938|"~     Increasingly patients with critical illness requiring life support in an intensive care unit~     are surviving their hospital admission. Currently the investigators do not know what effect~     the ICU admission, and the life support, has on their long-term quality of life and whether~     they can return to their pre-illness level of function following ICU.~      The investigators aim to test telephone follow-up of ICU survivors in assessing function and~     quality of life six months after ICU admission. Additionally, the investigators will identify~     if there are factors that lead to poor recovery. The investigators hope this can influence~     and change current ICU practice to improve recovery and long-term outcomes for patients.~      The investigators aim to select a total of 300 patients from ICU, 75 patients from each of~     the four ICUs. If they survive to hospital discharge, patients and their relatives will~     receive a telephone questionnaire at 6 months after the ICU admission that aims to assess~     their long-term outcomes, including physical, cognitive and emotional function, quality of~     life, and whether they have been able to return to work following ICU.~   "
102482|NCT02225925|"~     The purpose of this study is to assess the performance of a system of intraoperative dynamic~     dosimetry during prostate seed implantation (brachytherapy) including its new elements, to~     evaluate and refine technical methods of using the system, as well as confirm its performance~     and accuracy.~   "
102483|NCT02225912|"~     The hypothesis was to establish whether the use of PrevinC administered nasally 2-3 times a~     day will prevent upper respiratory infections in otherwise healthy adults working in child~     day care centers.~   "
102484|NCT02225899|"~     With better medical care, patients with cystic fibrosis (CF), a life-threatening disease, are~     enjoying longer lives. As the CF life expectancy increases, conditions such as CF-related~     diabetes (CFRD) become more prevalent. Nutrition plays a major role in maintaining optimal~     health in cystic fibrosis (CF). This project is designed to investigate nutrition-related~     factors, such as vitamin D status, on oxidative stress and fat oxidation which may influence~     long-term survival in CF and CFRD. Based on preliminary clinical and metabolomics research~     findings, the working hypotheses of this project are: 1) oxidative stress in CF contributes~     to impaired fat oxidation, and 2) vitamin D supplementation normalizes oxidative stress and,~     subsequently, fat oxidation. This study will combine state of the art methods with~     traditional clinical methods to assess fat oxidation, oxidative stress, and nutritional~     status in adults with cystic fibrosis. Research methods include blood draws for plasma~     markers of oxidative stress and metabolomics (the measurement of thousands of small chemicals~     in the blood), magnetic resonance imaging (MRI, to assess energy capacity and thigh fat),~     dual energy X-ray absorptiometry (DEXA, to assess total and regional body fat and muscle),~     and indirect calorimetry (to assess resting energy expenditure and whole body fat oxidation).~     Clinically-relevant data, such as lung function, CF genotype, and diabetes status will be~     obtained from the electronic medical record and the CF Registry. This study consists of two~     sub-studies. The first is a cross-sectional study in 66 clinically-stable adults with CF and~     44 healthy control participants. Testing in clinically-stable adults will occur in the Emory~     University Hospital (EUH) Clinical Research Network (CRN) outpatient unit (blood draws,~     indirect calorimetry, DEXA) and in the Emory University Biomedical Imaging Technology Center~     (BITC) for MRI imaging. The second study will be an ancillary longitudinal study to the~     ongoing, double-blind, placebo-controlled, randomized high-dose vitamin D trial (DISC Study,~     IRB00052829, PI: Tangpricha) in patients with CF who are hospitalized for pulmonary~     exacerbation. Blood draws and indirect calorimetry will be performed in patients within 72~     hrs of hospital admission (before vitamin D dosing), and during 3 and 6 month outpatient~     follow-up visits. The data generated from this study will be used to inform future nutrition~     intervention studies in adults with CF and CFRD.~   "
102485|NCT02225886|"~     The administration of ascorbic acid seemed to increase the iron available for erythropoiesis,~     thus improving the anemia response to the treatment.~      The investigators therefore aimed to evaluate the effects of intravenous ascorbic acid~     administration in hemodialysed patients with iron overload.~   "
102486|NCT02225873|"~     This study will verify whether the cranio-cervical flexion coordination (motor control) and~     muscle strength training protocol is more effective in improving muscle than the~     proprioception and muscle strength protocol in patients with chronic neck pain.~      Hypothesis: The craniocervical flexion (motor control) and muscle strength training protocol~     will improve muscle function more than the proprioception and muscle strength protocol in~     patients with chronic cervical pain.~      Objective: To find out if applying the strength therapeutic exercise protocol and the~     craniocervical flexion coordination (motor control) training is more effective than the~     strength and articular repositioning protocol when carrying out the craniocervical flexion~     test in patients with chronic cervical pain.~   "
102487|NCT02225860|"~     The purpose of this study is to learn if dietary habits can affect vasopressin secretion in~     patients with autosomal dominant polycystic kidney disease. Vasopressin increases the growth~     of kidney cysts and accelerates disease progression. Understanding how to control secretion~     of this hormone based on dietary habits may help to develop treatments to control this~     disease. The study will include about 60 patients from Tufts Medical Center. The study will~     last for 2 weeks. Blood and urine tests will be done 3 times during the study period.~     Subjects will be randomly assigned (by chance like flipping a coin), to one of two study~     groups. Group 1 will be given instructions to adjust their diet. This will include adjusting~     the amount of water, protein, and salt intake. Group 2 will have no adjustment of diet or~     water. The project has tremendous public health relevance, given the large numbers of people~     affected by autosomal dominant polycystic kidney disease and the substantial impact of the~     disease on morbidity, mortality, hospitalizations,dialysis or transplant, and societal costs~     of caring for those patients.~   "
102488|NCT02225847|"~     The objective of the research is to test the hypothesis that participating in group-based~     gardening activities alters brain network activation and function, and that such change~     occurring in the brain forms the neurobiological basis for much of the nonphysical activity~     portion of the therapeutic benefits of gardening and horticultural therapy. Assessment of the~     effects of the gardening activities on the experimental population will take two approaches,~     the first being the use of functional Magnetic Resonance Imaging (fMRI) to assess the regions~     of the brain that may become activated as a consequence of experiencing the cumulative~     gardening activities and associated stimuli. The allied approach will employ widely used and~     well-established self-reported assessment instruments that will capture information about the~     health and well-being that will then provide a psychometrically-based before and after~     physical and health summary of the participants in the control group and those engaged in the~     gardening activities.~   "
102489|NCT02225834|"~     Recent clinical trials and meta-analyses of b-hydroxy-bmethylglutaryl coenzyme A (HMG-CoA)~     reductase inhibitors (statins) have demonstrated a significant reduction in ischemic stroke~     in patients with a history of coronary artery disease, both with and without elevations of~     serum cholesterol. Recent data suggest that statins have other beneficial properties in~     addition to the retardation of atherosclerosis. Asahi et al demonstred that Statins increased~     eNOS and tPA mRNA levels but did not change mRNA levels of PAI-1 and that In eNOS knockout~     mice, atorvastatin reduced the volume of ischemic tissue and improved neurologic outcomes~     after arterial occlusion by blood clot emboli. In addition to their lipid-lowering effects,~     it has been speculated that statins may also have beneficial effects on cerebral circulation~     and brain parenchyma during ischaemic stroke and reperfusion. Aslanyan et al reported that~     statin use was associated with reduced mortality at 1 month during the follow-up.~      In patients with recent stroke or TIA and without known coronary heart disease, 80 mg of~     atorvastatin per day reduced the overall incidence of strokes and of cardiovascular events,~     despite a small increase in the incidence of hemorrhagic stroke period .~      Recently the investigators group reported that lacunar strokes compared to nonlacunar ones~     exhibited significantly lower plasma levels of TNF-α and IL1-β, P-selectin and ICAM-1 24-72 h~     and 7-10 days after stroke onset (4). At extracranial arterial territories, inflammation~     plays a crucial role mediating all the stages of the atherosclerosis process . Similarly,~     thrombosis and defective fibrinolysis may also contribute to the progression of~     atherosclerotic lesions . Interestingly, both mechanisms might have a relevant role in the~     pathogenesis of intracranial large artery atherosclerosis and ischemic stroke Moreover our~     group showed that Patients with cardioembolic and atherothrombotic stroke subtypes showed~     significantly higher median plasma levels of TNF-α, IL-6, IL-1β whereas the lacunar subtype~     showed significantly lower median plasma levels of TNF-α, IL-6 and IL-1β and that~     immunoinflammatory marker plasma levels are significantly related to ischemic lesion volume.~      A meta-analysis showed that statins may possess antithrombotic property because these drugs~     were reported to reduce periprocedural infarction in patients undergoing percutaneous~     coronary intervention .~      This clinical benefit was detected after median, 0.5 days of treatment with statins~     (indicating that statins could potentially exert an antithrombotic effect even earlier than~     supposed from pharmacological studies.~      Violi et al recently showed the first evidence that atorvastatin acutely and simultaneously~     decreases oxidative stress and platelet activation by directly inhibiting platelet Nox2 and~     ultimately platelet isoprostanes and thromboxane A2 so providinf a rationale for the use of~     statins to prevent or modulate coronary thrombosis.~      Whereas recent data suggest that inflammatory reactions are involved in the pathogenesis and~     progression of cerebral ischaemia , no study has evaluated effects of atorvastatin 80 mg/day~     after a recent stroke on stroke outcome and on immunoinflammatory markers so to evaluate~     acute antithrombotic and anti-inflammatory effects of atorvastatin also in acute~     cerebrovascular event setting.~      On this basis the primary objective of the study was to evaluate the separate effects of~     atorvastatin in vivo on immunoinflammatory markers and on stroke prognosis in patients with~     recent acute ischemic stroke classified as atherothrombotic.~   "
102490|NCT02225821|"~     In the Netherlands about 18,000 surgical procedures with implant removal are annually~     performed after fracture healing, of which 30-80% concern the foot, ankle and lower leg~     region. For clean surgical procedures, the rate of postoperative wound infections (POWIs)~     should be less than 5%. However, rates of 10-12% following implant removal, specifically~     after foot, ankle and lower leg fractures are reported. Currently, surgeons decide~     individually if antibiotics prophylaxis is given, since no guideline exists. This leads to~     undesirable practice variation.~      Therefore, the investigators propose a double-blind randomized controlled trial (RCT) in~     patients scheduled for implant removal following a foot, ankle or lower leg fracture, to~     assess the (cost-)effectiveness of a single gift of antibiotic prophylaxis. Primary outcome~     is a POWI within 30 days after implant removal. Secondary outcomes are quality of life,~     functional outcome at 30 days and 6 months after implant removal and costs.~      With 2 x 250 patients a decrease in POWI from 10% to 3.3% (expected rate in~     clean-contaminated elective orthopedic trauma procedures) can be detected (Power=80%, 2-sided~     alpha=5%, including 15% lost to follow up).~      If the assumption of the investigators, that prophylactic antibiotics prior to implant~     removal reduces the infectious complication rate, is confirmed by this RCT, this will offer a~     strong argument to adopt a single gift of antibiotic prophylaxis as standard practice of~     care. This will reduce the incidence of POWIs and consequently will lead to less physical and~     social disabilities and health care use. In addition, it will decrease the rate of use of~     empiric broad-spectrum antibiotics (and antibiotic resistance) prescribed upon suspicion or~     diagnosis of a POWI. A preliminary, conservative estimation suggests yearly cost savings in~     the Netherlands of €3.5 million per year.~   "
102491|NCT02225808|"~     This is an open, pilot study of neural mechanisms of cognitive-behavioral therapy for anxiety~     in children with high-functioning autism spectrum disorder (ASD). In addition to the core~     symptoms, approximately forty percent of children with ASD exhibit clinically significant~     levels of anxiety. Cognitive-Behavioral Therapy (CBT) is a promising treatment for anxiety in~     children with high-functioning ASD, but the neural mechanisms of this treatment have not been~     studied. CBT teaches emotion regulation skills such as cognitive reappraisal, followed by~     behavioral exposure to anxiety-provoking situations. The investigators propose to investigate~     the neural mechanisms of CBT for anxiety by evaluating fMRI indices of socioemotional~     functioning before and after treatment in children, ages 8 to 14, with high-functioning ASD.~     Dysfunction of the amygdala and its connectivity with prefrontal cortex has been implicated~     in co-occurring ASD and anxiety. In the investigators research, compared to typically~     developing controls, children with ASD have shown lower activation in several regions of~     prefrontal cortex and a lack of down-regulation in the amygdala during a task of emotion~     regulation. Based on these observations, the investigators propose that a positive response~     to CBT for anxiety in children with ASD will be associated with increased activation of~     several regions in the prefrontal cortex as well as increased functional connectivity between~     prefrontal regions the amygdala during the task of emotion regulation. The primary aim of~     this pilot study is to examine the effects of CBT on the neural basis of anxiety in ASD by~     collecting fMRI data during emotion regulation, face perception, and rest before and after~     treatment. The investigators hypothesize that CBT will increase prefrontal activity, decrease~     amygdala reactivity, and enhance amygdala-prefrontal functional connectivity during emotion~     regulation. The investigators also hypothesize that CBT will decrease amygdala reactivity~     during perception of emotional faces. Additional analyses will be conducted to explore change~     in resting-state functional connectivity before and after CBT for anxiety in children with~     ASD.~   "
102492|NCT02225795|"~     This is a study for people with Crohn's Disease (CD) that are not responsive to standard~     treatment. CD is a chronic disease with an auto-immune component that goes away and relapses~     over the years and causes lifelong impairment of health and quality of life. Regardless of~     the therapy used some patients remain seriously ill with active disease after multiple~     therapeutic options have been exhausted. There is currently no drug that will cure CD. Drug~     treatment is focused on controlling symptoms. Another treatment is to perform surgery but~     again this does not lead to cure and is often linked to infection, short gut syndrome~     problems and psycho-social and cosmetic issues. Therefore, a treatment that does not involve~     surgery or long-term drug treatment may be beneficial especially to young adults.~      Hematopoietic stem cell transplantation (HSCT) has been of value in other auto-immune~     diseases and it is possible that it could be of value in CD. This is a pilot study to~     determine if HSCT is safe and effective for children and young adults with severe CD. For~     this study the stem cells will come from the patient. This is called an autologous~     transplant. The patient will undergo collection and storage of his/her peripheral blood stem~     cells (PBSC). The patient will be given drugs to move (or mobilize) the stem cells from~     his/her bone marrow into his/her blood where they will be collected on a machine called~     apheresis (similar to dialysis.) The cells will be stored and given back to the patient about~     1 month after collection.~   "
102493|NCT02225782|"~     Hemodialysis is a procedure that kidney physicians perform when the kidneys fail and can no~     longer clean the blood and remove extra fluid and toxins from the body. Hemodialysis~     therefore requires access to reach the blood through either a surgically created permanent~     fistula or graft or through the insertion of a temporary catheter in one of the large body~     veins. While the use of fistulas or grafts is preferred because they are permanent, there may~     be conditions that prevent patients from having them and a hemodialysis catheter may be used~     instead. The problem with the use of catheters however is that they can become blocked due to~     the formation of blood clots. Kidney physicians try to resolve occlusion of hemodialysis~     catheters by injecting a medication called Alteplase which breaks the clot at the catheter~     site. There is no consensus in the medical community as to how much of the medication should~     be injected at the occluded catheter site. While some kidney physicians and studies recommend~     the use of 1.0 mg of the medication at each occlusion site, others recommend that 2.0 mg of~     the medication should be used. Thus, the purpose of this randomized clinical trial is to~     compare the effectiveness of 1.0mg versus 2.0mg dose of alteplase in resolving blood clots in~     hemodialysis catheters.~      The investigators will recruit patients for the study from a regional hemodialysis unit that~     is located in southwestern Ontario. Patients who agree to participate in this research and~     experiences occlusion of their hemodialysis catheters will be divided into two groups; making~     sure that this division is completely by chance. The first group will receive 1.0mg~     alteplase, while the second will receive 2.0mg Alteplase. The investigators will collect~     information on both groups and will run statistical analysis of these information to compare~     the results of clot resolution between the groups.~   "
102513|NCT02225522|"~     The purpose of this study is to compare the effectiveness of rapid next generation sequencing~     (NGS, such as whole genome sequencing1) with current practice to provide diagnostic or~     prognostic information or treatment guidance in acutely ill neonates and infants,~     particularly with respect to clinical care, cost and outcomes.~   "
102561|NCT02224898|"~     The research objective of this pilot study is to test the feasibility of a mobile electronic~     mindfulness therapy service for patients with definite or suspected chronic pancreatitis.~      A secondary aim will be to determine the effect of the intervention on a symptom~     severity/global assessment of improvement for patients with chronic pancreatitis. The~     investigators hypothesize that a one-month period of daily mindfulness therapy delivered via~     a phone messaging service will reduce symptoms.~   "
102494|NCT02225769|"~     Health professionals in developing countries have limited ability to identify children at~     risk of dying and those in need of antibiotics. The main reasons are limited clinical skills~     and time, unavailability of diagnostic tests (laboratory or x-ray) and non-adherence to~     practice guidelines. Child mortality is therefore higher than it should be. Etiological~     diagnostic tests (detecting microorganisms) may not always help since the distinction between~     infection and disease and between mild or severe disease is not straightforward.~     Overprescription of antibiotics is therefore widespread and leads to the development of drug~     resistance. To address these challenges, decision charts for the management of febrile~     illness will be developed and include i) few clinical parameters simple to assess, and ii)~     POCTs results based on specific host markers that can discriminate between mild and severe~     disease, pneumonia and upper respiratory tract infections, and unspecific fevers of bacterial~     and of viral origin. This algorithm combining clinical and bedside laboratory tests will be~     built on an electronic support (android tablet). The first objective of the study is to~     assess the safety of new electronic decision trees that integrate simple clinical assessment~     and POCTs results (oxygen saturation and a combination of specific biomarkers of~     inflammation) as a triage tool to decide on admitting febrile children; the second objective~     is to assess the usefulness and safety of new electronic decision trees that integrate simple~     clinical assessment and POCT results (a combination of specific biomarkers of inflammation)~     as decision-making tool to prescribe antibiotics to non-severe febrile children. The~     development of such a tool will decrease mortality due to delayed admission, At the same~     time, it will decrease irrational use of antibiotics, and hence drug pressure and emergence~     of drug resistance, which represents one of the most important public health threat our world~     is facing today. This project has the potential of huge applicability since it is~     specifically designed for end-users with limited medical skills and low resources, as it is~     the case in most areas of developing countries.~   "
102495|NCT02225756|"~     Aneurysms of the aorta are dilatations of the main artery in the body that distributes blood~     to organs. Aneurysms expose patients to aortic rupture. The risk of aortic rupture is high~     for large aneurysms, and low for small aneurysms. Currently, if the diameter of a small~     aneurysm grows up to a level at risk for rupture, surgery is indicated to prevent rupture. A~     drug that would stop growth of small aneurysms would obviate aortic surgery, the current~     treatment to prevent aortic rupture in patients. The ACA4 study aims at testing the~     possibility to stop growth of small aortic aneurysms in the abdomen with a drug, cyclosporine~     A. Patients with small aneurysms will receive cyclosporine A orally, or a placebo (fake~     liquid), every day during a short period of time. Efficacy of the drug will be evaluated by~     measuring the diameter of the aneurysm during 2 years after treatment cessation. Drug safety~     analysis will evaluate the impact of the drug on renal function, blood pressure, and other~     parameters. In case of adverse event during the drug administration phase, dose of the drug~     or of the placebo will be decreased or administration stopped.~   "
102496|NCT02225743|"~     Total joint patients have poor outcomes with infection since they are having permanent~     hardware implanted. Infection prevention in this group is therefore critical and a major~     source of discussion in both the orthopedic and anesthesia literature.~      Hypothermia has been shown to increase the risk of infection and blood loss. However, studies~     have not examined when in the operation or how fast patients temperatures drop. This study~     will observe how patients' temperatures change during total joint arthroplasty. By~     identifying when body temperature changes occur, prevention strategies may be developed and~     implemented.~   "
102497|NCT02225730|"~     Stroke is caused by a sudden blockage of a blood vessel that delivers blood to the brain.~     Unblocking the blood vessel with a blood clot removal device restores blood flow and if done~     quickly may prevent the disability that can be caused by a stroke.~      However, not all stroke patients benefit from having their blood vessel unblocked.~      The aim of this study is to determine if special brain imaging, called MRI, can be used to~     identify which stroke patients are most likely to benefit from attempts to unblock their~     blood vessel with a special blood clot removal device. In particular, we will assess in this~     trial whether a noncontrast MR imaging sequence, arterial spin labeling (ASL), can~     demonstrate the presence of collateral blood flow (compared with a gold standard of the~     angiogram) and whether it is useful to predict who will benefit from treatment.~   "
102498|NCT02225717|"~     The investigators project aims to identify, in pregnant women, discriminating molecules to~     allow an early detection of women who will spontaneously deliver prematurely, suitable in~     routine clinical practice.~      Human parturition is tightly correlated with hormonal changes at the maternal-fetal interface~     during pregnancy, that may control cell interactions and fetal membranes (the water bag)~     remodelling. Precocious remodelling may lead to a premature onset of labor, associated or not~     with premature rupture of membrane whether the cause is infectious or not.~      In this regard, remodelled fetal membranes overlying the cervix may discharge signals that~     could be detectable in cervico-vaginal fluids and serve as biomarkers of the imminence of~     delivery. Such information on delivery timing may be of great importance for an adequate~     prediction that would change drastically the management of threatening preterm delivery.~   "
102499|NCT02225704|"~     This study aims to determine the safety and tolerability of Radium-223 when administered in~     combination with enzalutamide in progressive metastatic castrate-resistant prostate cancer.~   "
102500|NCT02225691|"~     This study aims is to evaluate the effect of introducing paired testing on actual testing~     frequency, glycemic control, psychosocial and behavioural aspects of poorly controlled~     diabetes patients in China.~   "
102501|NCT02225678|"~     Can a clinical test be developed that could help manage asthma symptoms?~   "
102502|NCT02225665|"~     The purpose of this study is to evaluate the safety and tolerability of repeat doses of~     T-cell immunotherapy (SB-728mR-T) following cyclophosphamide conditioning.~      CCR5 is a major co-receptor for HIV entry into T-cells. Disruption of CCR5 by zinc finger~     nuclease (SB-728mR), blocks HIV entry into the T-cells, therefore, protects the T-cells from~     HIV infection. Safety (primary outcome) and anti-viral effect (secondary outcome) of zinc~     finger nuclease-mediated CCR5 disrupted autologous T-cells (SB-728mR-T) will be evaluated in~     the study.~   "
102534|NCT02225249|"~     Lung transplantation is a well established method for surgical therapy for patients with end~     stage pulmonary disease.~      The investigators seek to determine to which extent the pulmonary vascular barrier gets~     harmed during lung transplantation and whether pulmonary edema after reperfusion can be~     monitored with measurement of extravascular lung water index (ELWI).~      Additionally the investigaors are going to evaluate the correlation between ELWI and shedding~     of the endothelial glycocalyx.~      The study is designed as a prospective observational cohort study.~   "
102562|NCT02224885|"~     This study is a prospective study in order to demonstrate the technical feasibility and~     safety of doing endomicroscopic imaging during interventional radiology procedure in two main~     indications: lung and liver.~      This innovative study will involve the use of probe-based confocal laser endomicroscopy. The~     proposed study is a feasibility study.~   "
102503|NCT02225652|"~     TITLE: A Phase II Study of Dose Density Regimen with Fluorouracil, Epirubicin and~     Cyclophosphamide at Days 1, 4 Every 14 Days with Filgrastim Support followed by Weekly~     Paclitaxel in Women with Primary Breast Cancer.~      PROTOCOL CODE: IRST 174.05~      PHASE: II~      STUDY DESIGN: Pharmacological, open-label, prospective, not randomized, monocentric trial~      DESCRIPTION OF STUDY TREATMENT:~      FEC + filgrastim x 3 cycles q 14-21 days~      Day 1 and day 4 = FEC (FLUOROURACIL 500 mg/m2 IV infusion of 30 minutes + EPIRUBICIN 60 mg/m2~     IV infusion of 1 hour + CYCLOPHOSPHAMIDE 500 mg/m2 IV infusion of 30 minutes).~      From day 7 until hematological recovery = Filgrastim 300 microg s.c.~      After 21 days from the last FEC cycle = Paclitaxel 100 mg/m2 IV infusion of 1hour (weekly for~     8 cycles, at day 1).~      NUMBER OF SUBJECTS: in the first stage, 11 patients have been planned, with an additional 27~     patients to the second stage if at least 7 patients complete the planned treatment.~      OBJECTIVES~      Primary objective: this trial is designed to assess feasibility of the proposed regimen with~     regard to toxicity and deliverability. Tolerability is defined as absence of any grade 3 or~     higher nonhematologic toxicity (excluding alopecia, nausea/vomit, and bone pain, which might~     be a consequence of the administration of filgrastim). Deliverability is measured as the~     percentage of patients who complete the planned treatment.~      Secondary objectives:~        -  Relapse-free survival: measured from enrollment to the first date between date of~          documented relapse (or death) or date of last tumor assessment (if no documented~          relapse), or the date of last tumor assessment before the start of any further antitumor~          therapy not planned in the protocol.~        -  Overall survival: measured from enrollment to the date of death of any cause or last~          follow-up.~      CORRELATIVE/SPECIAL STUDIES: to evaluate retrospectively potential biomarkers of activity and~     toxicity of this regimen, blood and plasma samples until 15 mL each one will be collected at~     study entry, before first docetaxel administration and 3-4 weeks after last docetaxel~     administration. Moreover, a paraffin block or specimens of the primary tumor will be~     collected for biological studies.~      STATISTICAL CONSIDERATIONS: This trial is designed to assess feasibility of the proposed~     regimen with regard to toxicity and deliverability.~      Tolerability is defined as absence of any grade 3 or higher non-hematologic toxicity~     (excluding alopecia, nausea/vomit, and bone pain, which might be a consequence of the~     administration of filgrastim).~      A Simon two-stage design has been used with a 60% tolerability rate considered not promising~     and an 80% tolerability rate as promising, and probability of type I and type II errors has~     been set to be 0.10.~      In the first stage, 11 patients have been planned, with an additional 27 patients to the~     second stage if at least 7 patients complete the planned treatment. The regimen would be~     considered tolerable and worthy of further study if at the end of the trial 27 out 38~     patients complete the planned treatment.~   "
102504|NCT02225639|"~     The primary objective of this study is to assess the time of onset and time course of~     efficacy over 16 hours of PRC-063 compared to placebo in adults diagnosed with ADHD in a~     simulated adult workplace environment (AWE) setting, as measured by the PERMP (an~     individually-adjusted math test) at pre-dose, 1.0, 2.0, 5.0, 8.0, 11.0, 14.0 and 16.0 hours~     post-dose.~   "
102505|NCT02225626|"~     Effect of food on the pharmacokinetics of BI 1060469 (formulation tablet) in healthy male~     subjects as well as to investigate pharmacokinetics, safety and tolerability~   "
102506|NCT02225613|"~     Knee cruciate ligament injury is a common injury (15 000 per year in France) which concerns~     young sportsmen. Consequences are limitation in physical and sporting activities and at work.~      Main objective: to compare water and traditional rehabilitation after cruciate ligament~     injury reconstruction in terms of kinematics of recovery and of proprioceptive abilities~     development.~   "
102507|NCT02225600|"~     The study will examine behavioral patterns and underlying neural correlates which distinguish~     patients with borderline personality disorder (BPD) from healthy subjects as they participate~     in a two-person trust game and will determine whether administration of intranasal oxytocin~     (OT) will normalize trust game performance and concomitant neural processing in the BPD~     group.~   "
102508|NCT02225587|"~     The purpose of this study is to evaluate the safety and immunogenicity of sequential~     administration of Prevnar 13™ and Pneumovax™ 23 in healthy participants 50 years of age and~     older. The primary hypotheses in the study are that 1) geometric mean titers (GMTs) to~     pneumococcal serotypes 22F and 33F (serotypes in Pneumovax™ 23 but not in Prevnar 13™) as~     measured at Week 12 are superior in participants administered Prevnar 13™ on Day 1 and~     Pneumovax™ 23 at Week 8, as compared with participants administered Prevnar 13™ on Day 1 and~     placebo at Week 8 and 2) GMTs to pneumococcal serotypes shared by the two vaccines as~     measured at Week 12 are non-inferior in participants administered Prevnar 13™ followed by~     Pneumovax™ 23 as compared with participants administered Prevnar 13™ followed by placebo.~   "
102509|NCT02225574|"~     The goal of this clinical research study is to find the highest tolerated dose of the~     combination of nilotinib and MEK-162 that can be given to patients with CML or acute~     leukemia. Researchers also want to learn if the drug combination can help to control the~     disease. The safety of the drug combination will also be studied.~   "
102510|NCT02225561|"~     Approximately 50,000 patients are victims of out of hospital cardiac arrest every year in~     France. Despite cardiopulmonary resuscitation (CPR) and many studies on the topic~     resuscitation survival after cardiac arrest remains low (1-8%) and has not changed~     significantly over the past five decades.It has recently been shown that the combination of~     different non-invasive therapies, cardiopulmonary resuscitation with mechanical CPR with~     automated compression / decompression and an impedance threshold device, can increase the~     rate of return of spontaneous circulation and short and long term survival after cardiac~     arrest.We propose to study a new cardiopulmonary resuscitation called SNPeCPR (Sodium~     nitroprusside enhanced cardiopulmonary resuscitation), which includes two components:a) a~     mechanical component: cardiopulmonary resuscitation with automated mechanical external chest~     compression and an impedance threshold deviceb) a pharmacological component: sodium~     nitroprusside, an effective arterial vasodilator that decrease vascular resistance, and~     improve flow in vital organs.Our hypothesis is that SNPeCPR should improve the return of~     spontaneous circulation rate during cardiac arrest.~   "
102511|NCT02225548|"~     The purpose of this study is to see if selegiline and tadalafil (generic for Cialis®) results~     in an improvement in Erectile dysfunction (ED) in male patients with Parkinson's disease (PD)~     and moderate ED. Male PD patients who have an incomplete response to tadalafil alone will be~     given both medications to see if the addition of selegiline improves ED symptoms more than~     tadalafil alone. It is common practice for a medical doctor to prescribe these two drugs to a~     patient like you. However, there have been no studies conducted to examine the effects of~     these medications when taken together.~      Selegiline is normally prescribed for PD patients that are taking carbidopa/levodopa who are~     not receiving complete benefit from carbidopa/levodopa.~      Tadalafil is normally prescribed to men who have erectile dysfunction and/or benign prostatic~     hyperplasia (BPH).~   "
102512|NCT02225535|"~     The purpose of this project is to compare usual care for chronic low back disorders in a~     rural setting (nurse practitioner/NP) to two different means of integrating Physical Therapy~     (PT) into a rural health care team:~        1. in-person PT assessment, where the PT travels from an urban center~        2. interprofessional Telehealth assessment where the local NP is joined by a PT via~          Telehealth.~      The project will evaluate health, systems and process outcomes, comparative effectiveness and~     costs of the three methods of assessment. The hypothesis is that an interprofessional~     Telehealth assessment with be as effective as an in-person PT assessment, but more effective~     than usual care.~   "
102514|NCT02225509|"~     1. Principal objective:~           The primary objective of this study is to validate the diagnostic performance of a Dx15~          molecular test based on molecular transcriptomic signatures previously identified in~          distincts cohorts of samples to determine the malignant or benign profile of a thyroid~          nodule with indeterminate cytological analysis. The target population includes~          categories III [Follicular lesion of undetermined significance or Atypia of undetermined~          significance (FLUS/AUS)] and IV [Follicular neoplasm / Suspicious for follicular~          neoplasm (FN/SFN)] of the Bethesda classification.~           The expected target performance of the Dx15 molecular test in this target population is~          95% for specificity with a lower limit of the 95% confidence interval of 87%, and 75%~          for sensitivity.~        2. Secondary objectives:~             -  To assess the performance of the Dx15 test in samples collected during the study by~               fine-needle aspiration (FNA) in each and in all of the indeterminate Bethesda~               classification categories (categories III, IV and V: suspected malignancy)~             -  To assess the performance of the TI-RADS ultrasonography score for diagnosing~               thyroid cancer in patients presenting with a thyroid nodule and having available~               cytological analysis results.~             -  To check the potential of performance of the molecular signature as well as of its~               combination with other tests by applying it in a blind manner to samples collected~               from patients presenting with thyroid nodules and whose aspiration biopsy result is~               benign (Bethesda category II), malignant (Bethesda category VI) or non-diagnostic~               (Bethesda category I)~             -  To assess the performance of mutation tests (isolated mutations, chromosomal~               rearrangements) for diagnosing thyroid cancer in patients presenting with a thyroid~               nodule and with available cytological results.~             -  To estimate the performance of the combination of the Dx15 test result and other~               diagnostic tools such as mutation tests and/or the TI-RADS score to diagnose~               thyroid cancer in patients presenting with a thyroid nodule and having an~               indeterminate cytology result (especially AUS/FLUS and FN/SFN). The combination of~               Dx15 diagnostic test results with other study parameters will also be considered in~               order to establish the option of an algorithmic approach for the diagnosis of~               thyroid cancer.~             -  To compare the results of cytological and histological analyses obtained in the~               centres and by centralised reading and assessment of the impact of its results on~               the other study analyses and parameters.~             -  Additional analyses deemed relevant on the basis of various parameters and data~               collected during the study.~        3. Objective of exploratory research:~             -  The use of all or part of the FNA samples for the purpose of research as part of~               thyroid cancers, especially with the objective of optimising or identifying~               additional molecular signatures.~   "
102515|NCT02225496|"~     Standard-of-care treatment options for oropharyngeal cancer often result in long-term side~     effects that interfere with normal quality of life. A minimally-invasive transoral robotic~     surgery (TORS) approach has been developed to operate on the disease site while affecting the~     surrounding tissue as little as possible. Researchers think that this approach may help to~     control the disease and avoid such long-term side effects.~      The goal of this clinical research study is to learn if minimally-invasive transoral robotic~     surgery (TORS) can help to control HPV-positive oropharyngeal cancer. Transoral means through~     the mouth. The TORS approach is called the Intuitive Surgical da Vinci Surgical System.~      Researchers also want to learn if this surgery affects participants' ability to speak and~     swallow.~   "
102516|NCT02225483|"~     The is study will examine whether variation in clinical bleeding frequency and severity among~     boys with severe Hemophilia A (Factor VIII deficiency) is associated with variations in~     laboratory measurements of platelet activity.~   "
102517|NCT02225470|"~     This study is designed as an open-label randomized parallel two-arm multicenter efficacy,~     pharmacokinetics and safety study of intravenously administered eribulin versus intravenously~     administered vinorelbine in Chinese population. Eligible female subjects will have measurable~     disease according to RECIST 1.1 with the modification that chest x-ray cannot be used for~     assessment of disease.~   "
102518|NCT02225457|"~     Obesity results from complex interactions between genetic and environmental factors, and are~     strongly associated with metabolic complications such as type 2 diabetes mellitus. Obesity is~     defined as an excessive fat accumulation that presents a risk to health, a risk that is~     highly dependent upon the type of adipose tissue accumulation, whether visceral or~     sub-cutaneous, but also upon the characteristics of the fat tissue, especially inflammatory~     cells accumulation. Because of the well known sexual difference in fat accretion, this~     obesity-associated risk may also be very different for men and for women. In addition, recent~     data indicate that various factors such as the intestinal microbiota, but also the dietary~     intake of protective nutrients might be important determinants of the metabolic complications~     of obesity.~      Here we propose to: 1) study the metabolic adaptations and the mechanisms of adipose tissue~     accumulation during a period of controlled caloric over-nutrition, both in men and in women;~     2) evaluate the potential protective effects of a supplementation with polyphenols on insulin~     resistance and other metabolic adaptations.~   "
102519|NCT02225444|"~     OsteoAMP is an allograft (transplantation of part of one person to another person) derived~     growth factor rich bone graft for use in spinal fusion. The study is designed to obtain a~     higher level of clinical evidence for OsteoAMP in spinal fusion procedures and not to garner~     FDA regulatory approval. This is a prospective, non-randomized, non-controlled, multi-center~     study of OsteoAMP in instrumented, posterolateral lumbar fusion (PLF) in patients with~     degenerative disc disease, degenerative spondylolisthesis (up to grade 1), and/or mild~     degenerative scoliosis, up to 25 degree curvature. Patients that are scheduled to undergo~     instrumented, posterolateral spinal fusion surgery as part of their medical treatment and~     comply with the study eligibility criteria will be given the opportunity to consent and be~     entered into the study.~   "
102520|NCT02225431|"~     The aim of this study was to evaluate, in patients with lower fluid status defined by~     bioimpedance analysis, whether two different protocol of IV isotonic saline infusion are~     associated with different volume expansion and differing risks for CI-AKI in patients~     undergoing coronary angiographic procedures.~   "
102521|NCT02225418|"~     The TQL block may prove a valuable method for treating postoperative pain following scopic~     removal of the gall bladder.~      The trial will compare active TQL block versus placebo TQL block after said operation.~      The hypothesis is that active TQL block significantly will reduce postoperative pain~     following scopic removal of the gall bladder compared with placebo TQL block.~   "
102522|NCT02225405|"~     The goal of this clinical research study is to learn if it is safe to give nintedanib in~     combination with cisplatin and docetaxel before surgery to patients with NSCLC. Researchers~     also want to learn if the drug combination can help to control NSCLC before surgery.~   "
102523|NCT02225392|"~     Approximately 5% of asthma patients suffer from severe asthma that is characterized by~     frequent asthma exacerbations resulting in significant morbidity and excessive utilisation of~     health care resources. Therefore, there is a strong need for improved therapeutic strategies~     for these patients. Insight in the pathogenesis and molecular pathways active in severe~     asthma is crucial to reach this goal.~      Bronchial Thermoplasty (BT) is a novel, innovative device-based treatment of severe asthma~     that is based on local, radiofrequent energy delivery in larger airways during bronchoscopy.~      Hypothesis:~      BT-induced clinical improvement in severe asthma is a consequence of reduction in airway~     smooth muscle (ASM) mass and (contractile/immunomodulatory) function, inflammation, neural~     innervation and/or vascular integrity resulting in altered airway remodelling. BT target~     identification and severe asthma phenotyping are critical for improved patient selection for~     BT and fundamental to discover novel, specific signalling pathways active in severe asthma.~   "
102524|NCT02225379|"~     Hypo Sense is a non- invasive method for detection of hypoglycemia. The Hypo Sense combines~     an array of non-invasive sensors which monitors the patient's physiological parameters (heart~     & respiration rate, perspiration, skin temperature and arm motion) designed as a wrist watch~     device.~      The Hypo sense is intended for monitoring symptoms of hypoglycemia in diabetic patients in~     hospital environment among type 1 and type 2 diabetes adults as an adjunctive device to~     reference methods~      The proposed study will be consisting of two main segments:~      The primary aim of segment 1 of the study is data collection and calibration of the Hypo~     Sense sensor prototype compared to standard invasive reference glucometer.~      The primary aim of segment 2 of the study is to validate the Hypo Sense prototype performance~     in detecting hypoglycemic events.~      During the first segment of the study we intend to collect in parallel measurements of blood~     glucose using reference method (capillary glucometer) and continuous data generated by the~     non- invasive study device during approximately 4 hours, in which a hypoglycemic event will~     be induced.~      The reference and study device data will be analyzed using multivariate regression model to~     formulate a calibration algorithm model. This model will translate the set of the~     physiological recorded parameters into detection of hypoglycemic events.~      During the second segment of the study we intend to evaluate the validity of the Hypo Sense~     sensor ability to detect hypoglycemic events compared to standard invasive reference method~     (capillary glucometer).~   "
102525|NCT02225366|"~     The goal of this clinical research study is to find the appropriate dose of LL37 that can be~     given to patients with melanoma. Researchers also want to learn if LL37 can stimulate the~     immune system to help control the disease.~   "
102526|NCT02225353|"~     Assess the efficacy of 2 Cervical Pessaries containing 6.3 g and 7.7 g micronized~     progesterone for the prevention of preterm delivery, established through spontaneous birth~     before gestation weeks 32 (31 6/7) and 34 (33 6/7), when the pessary is inserted during weeks~     16th and 24th and removed at 36 6/7 weeks in pregnant women at high risk of premature birth.~   "
102527|NCT02225340|"~     Familial hypercholesterolemia (FH) is an autosomal codominant single gene disorder caused by~     mutations in the LDL receptor gene (LDLR) that disrupt the normal clearance of LDL particles~     from the plasma. Heterozygous patients (HeFH) present a two- to three-fold raise in plasma~     LDL-cholesterol (LDL-C) concentrations and coronary artery disease occurs earlier among HeFH~     carrying negative-receptor (NR) mutations as compared with HeFH subjects carrying~     defective-receptor (DR) variants. Proprotein convertase subtilisin/kexin type 9 (PCSK9)~     regulates LDL-C levels by binding to LDLR and by enhancing its intracellular degradation.~      The objective of this study is to examine to what extent variations in LDL-C and Lipoprotein~     (Lp) (a) concentrations are related to PCSK9 levels in a large French-Canadian cohort of HeFH~     subjects.~      The primary hypothesis is that that PCSK9 levels have a significant impact on LDL-C~     concentration variability and are associated with Lp(a) levels.~   "
102528|NCT02225327|"~     Similar to children, adults frequently visit outpatient clinics to get two or more kinds of~     vaccines at the same time: pneumococcal vaccine, influenza vaccine, Td (diphtheria and~     tetanus) vaccine, HPV (human papilloma virus) vaccine, meningococcal vaccine, zoster vaccine,~     etc. This study is intended to evaluate the immunogenicity and safety of concomitant~     administration of 23-valent pneumococcal polysaccharide vaccine (PPV23, Prodiax) and MF59~     adjuvanted trivalent influenza vaccine in the elderly subjects aged ≥65 years.~   "
102529|NCT02225314|"~     Computer-Based Cognitive Training for Individuals with Parkinson's Disease is a 3-arm~     randomized controlled trial (RCT) comparing Brain Fitness, InSight, and an active control~     (AC) training program to evaluate the feasibility of empirically supported computer-based~     cognitive training programs (CCTPs) for patients diagnosed with Parkinson's disease (PD) with~     Mild Cognitive Impairment (MCI). This pilot study aims to address the need for increased~     interventions to target non-motor symptoms associated with PD.~   "
102530|NCT02225301|"~     Phase 1 was a randomized control trial that used a test-retest model to evaluate the impact~     of iLook Out for Child Abuse, an online, interactive learning module about reporting~     suspected child abuse. Delivered via a learning management system to early childhood~     professionals who work with infants and young children, this study assessed iLookOut's effect~     on 1) knowledge about reporting suspected child abuse; 2) attitudes toward reporting~     suspected child abuse; and 3) preparedness to protect children at risk.~      Findings from Phase 1 were that iLookOut will improved knowledge, changed attitudes, and~     increase self-reported preparedness of early childhood providers to report suspected child~     abuse.~      Phase 2 of this trial is an open-enrollment study that records pre-/post- data on the same~     measurements as Phase 1, and is available for use (free of charge) for all childcare~     providers in Pennsylvania at https://www.ilookoutforchildabuse.com.~   "
102531|NCT02225288|"~     This is a single-center, 4-group, open-label study in Japanese healthy elderly males. A total~     of 48 subjects will be randomized to one of four groups (A to D, 12 subjects/group) to~     administer one E2022 tape to designated sites.~   "
102532|NCT02225275|"~     The goal of this clinical research study is to learn if the combination of lenalidomide and~     obinutuzumab can help to control chronic lymphocytic leukemia or small lymphocytic lymphoma~     (CLL/ SLL). The safety of this drug combination will also be studied.~      This is an investigational study. Lenalidomide is FDA approved and commercially available for~     the treatment of multiple myeloma (MM), mantle cell lymphoma (MCL) and myelodysplastic~     syndromes (MDS). Lenalidomide is not indicated and is not recommended for the treatment of~     patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.~     Obinutuzumab is FDA approved and commercially available for the treatment of chronic~     lymphocytic leukemia (CLL).~      It is investigational to give lenalidomide and obinutuzumab together to treat CLL or SLL. The~     study doctor can explain how the study drug(s) are designed to work.~      Up to 30 patients will be enrolled in this study. All will take part at MD Anderson.~   "
102533|NCT02225262|"~     The purpose of this study is to determine the effects of CyberKnife radiosurgery in patients~     with early stage prostate cancer.~      The investigators hypothesize that hypofractionated stereotactic radiotherapy via the~     CyberKnife® can deliver tumor ablating doses of radiation to prostate tumors safely and~     effectively while sparing the adjacent tissues (rectum, bladder, ureters, urethra, penile~     bulb, and bowel) from receiving damaging doses of radiation.~   "
117065|NCT02035215|"~     The purpose of this study is to evaluate the efficacy and safety of combination therapy of~     omega-3-acids ethylesters 90/Atorvastatin calcium in type Ⅱb hyperlipidemia~   "
102535|NCT02225236|"~     This project will develop and evaluate the initial effectiveness of an intervention training~     executive functioning, metacognition, and self-regulation in preschoolers attending certain~     high poverty Cincinnati preschools. Studies show that these skills are critical for school~     performance, and that children with better executive functioning have better long term~     outcomes. It is also important to intervene early when children are most likely to profit~     because their brains are rapidly developing. There are some promising programs targeting~     these skills in preschoolers, but few are available to teachers for implementation in the~     classroom setting. The specific aims of this study are: 1) to adapt a promising clinic-based~     program for the preschool classroom environment, and 2) to test the feasibility and initial~     impact of the adapted program on executive functioning and school readiness in schools with a~     high proportion of children from low income families.~   "
102536|NCT02225223|"~     The purpose of this study is to evaluate treating painful metastatic lesions in vertebral~     bodies with pathologic fractures with targeted radiofrequency ablation (t-RFA) and vertebral~     augmentation (VA) prior to or following radiation therapy.~   "
102537|NCT02225210|"~     This study was designed to observe the effects of dexmedetomidine on delirium and~     haemodynamic in mechanical ventilated elderly patients,and to evaluate the safety of~     dexmedetomidine.~   "
102538|NCT02225197|"~     The purpose of this study is to find out what effects (good and bad) CyberKnife stereotactic~     radiosurgery has on tumors near the critical structures of the eye (optic apparatus).~      The investigators hypothesize that hypofractionated stereotactic radiotherapy via the~     CyberKnife ® can deliver tumor ablating doses of radiation to perioptic lesions safely and~     effectively while sparing the adjacent optic apparatus and normal brain tissues from~     receiving damaging doses of radiation.~   "
102539|NCT02225184|"~     Background:~      - Differences in peoples genes can make them respond to drugs in different ways. Methadone~     and buprenorphine are two drugs used to treat drug addiction. A study showed that African~     Americans with a certain genetic marker did better using one kind of drug treatment over the~     other. Researchers want to see if they can repeat these findings. They also want to study~     other things that affect how well people do in treatment.~      Objective:~      - To see if certain genetic markers and other facts about a person s life can predict how~     well they do in treatment for addiction to opioids and cocaine.~      Eligibility:~      - African American adults age 18 and over. They must be former or current participants in an~     Archway Treatment Clinic study. They must have been on a stable dose of either study drug for~     at least 12 weeks. They also must have given urine samples regularly for at least 10 weeks.~      Design:~        -  Participants will come to the clinic for 1 visit lasting about 2 hours.~        -  Participants will give 1 teaspoon of blood for genetic testing. They will be asked if~          their sample can be used in future studies.~        -  If researchers cannot get enough blood, they will do a cheek swab. This will collect~          skin cells for genetic testing.~        -  Participants will fill out 3 questionnaires.~        -  Results of genetic testing and answers to questionnaires will be kept private.~   "
102540|NCT02225171|"~     Preimplantation genetic diagnosis (PGD) is an assisted reproductive technology (ART) by which~     embryos, created through in vitro fertilization (IVF), can be screened for genetic conditions~     or traits before they are implanted into a woman s uterus. Within the past few years, a~     controversial non-medical use of PGD has gained recognition as having possible significant~     ethical implications. Non-medical sex selection (NMSS) describes the use of PGD technology to~     choose the sex of a child for social, as opposed to medical, reasons. In the US and a select~     few other countries, it is legal to use NMSS for family balancing, or the intentional~     selection of an underrepresented sex to balance a family where the majority of the children~     are of one sex. Proponents of family balancing believe that NMSS is an expression of~     reproductive autonomy and is ethically acceptable on those grounds. Opponents are more likely~     to cite beneficence (toward the existing children and the potential future child) and justice~     (resource allocation and access, for example) as the basis for concerns around NMSS and~     family balancing specifically. In the US and other countries, healthcare providers (HCPs) are~     often the gatekeepers to this technology. There is little research exploring the experiences~     of HCPs with PGD and NMSS. The Moral Experience framework (Hunt and Carnevale, 2011) is~     useful for understanding the potential concerns of HCPs as well as their feelings and~     behaviors evoked by lived and hypothetical experiences around NMSS. Also of interest is how~     HCPs feel that decisions about NMSS are made and their preferences as to how they should be~     made. Finally, there is concern that NMSS may be the first in a line of non-medical uses for~     PGD and that a slippery slope toward what some describe as designer babies will follow. We~     are interested in eliciting the traits that HCPs believe are hypothetically appropriate or~     inappropriate for PGD and how they make the distinction. Interviews with HCPs (OBGYNs and~     reproductive endocrinologists) on these topics will be transcribed and subjected to thematic~     analysis in order to identify common themes. An understanding of the experiences and~     attitudes of this stakeholder population can help clarify current issues at individual,~     societal, and global levels and future directions for research and policy....~   "
102541|NCT02225158|"~     Background:~      Tuberculosis (TB) is a severe disease and a major cause of death in many people worldwide. It~     is caused by a bacteria that enters through the lungs and can spread elsewhere in the body.~     People with latent TB have the bacteria that lie dormant but can become active and cause~     disease. These people are offered treatment to prevent development of active TB. Worldwide, a~     lot of people with LTBI also have a parasitic worm called a helminth that can stay in the gut~     or the blood. These parasites can affect the immune system and cause diseases like TB to~     become worse. Researchers want to see how helminth infection makes it harder for people to~     fight TB infection.~      Objectives:~      - To study how the immune system of people with latent tuberculosis infection (LTBI) acts to~     prevent development of active TB. Also, to study how helminth infection might affect this~     immune response.~      Eligibility:~        -  Adults age 18 70 with LTBI as defined by an approved blood test called QuantiFERON TB~          Gold.~        -  No evidence of infections like Hepatitis or HIV~        -  Pregnant subjects and subjects taking medications that suppress the immune system are~          not eligible.~        -  Have not received prior treatment for LTBI. Participants might be still eligible if~          prior treatment for active TB has been received~      Design:~      Screening phase:~      - Participants will be screened with medical history, physical exam, and blood tests for~     other infections/conditions which might affect the immune system. They will have testing for~     active TB i.e. blood testing as well as testing of their spit, scans and X-rays.~      Baseline phase:~        -  Only eligible participants will be entered into the study.~        -  Participants will have interviews, medical history, and physical exam.~        -  Blood will be drawn from an arm vein for testing.~        -  Participants will collect stool samples at home for 3 days in a row to test for helminth~          infection..~        -  Participants may have apheresis. Blood cells are removed by needle. They pass through a~          separator machine which returns everything but the cells back to the participant.~        -  Participants may have procedures at the start and end of the study that let researchers~          look into the lungs and collect cells.~      Study phase, about 2 years:~        -  All participants will be offered treatment for LTBI which lasts 6-9 months.~        -  Participants being treated for LTBI will have about 11 study visits. They will visit~          monthly for 9 months while on treatment, then 6 and 12 months after treatment.~        -  Participants not eligible/refusing treatment for LTBI will be made aware of active TB,~          then have 3 other visits, about 6, 12, and 24 months after the baseline visit.~        -  Participants who have helminth infection will receive appropriate treatment.~        -  All participants will have blood drawn at each visit.~   "
102560|NCT02224911|"~     This is a pilot, feasibility/exploratory study to evaluate the safety of laser interstitial~     thermal therapy (LITT) using Visualase in the focal treatment of localized prostate cancer as~     well as to gather data for the design of future studies.~   "
102563|NCT02224872|"~     Our primary objective is to determine if it is feasible for SAA patients to be transplanted~     using non-myeloablative conditioning and post transplantation cyclophosphamide with partially~     HLA-mismatched donors.~   "
102564|NCT02224859|"~     While using the device as a cushion, the passive distribution of pressure over bony skull~     prominences of infants will protect against formation of pressure ulcers.~   "
102542|NCT02225145|"~     Background:~      - Some treatments for cancer or other diseases can lead to infertility in women. These~     treatments include chemotherapy, some stem cell transplants, and pelvic radiotherapy. They~     are called gonadotoxic therapies. Women can now have their eggs frozen before they have these~     treatments. This may allow them to get pregnant later. Researchers want to learn more about~     this technology and processes.~      Objectives:~      - To provide egg freezing for women having gonadotoxic therapies at NIH. To learn more about~     the effects of these therapies.~      Eligibility:~      - Women at least 18 years old who are past puberty and before menopause. They must be~     scheduled to have gonadotoxic therapies.~      Design:~        -  Participants will be screened with medical history and blood and hormone tests. They~          will also have a physical exam and transvaginal ultrasound.~        -  Ovary stimulation: participants will have medications injected under the skin. These~          increase the chance of fertility. This phase will take about 8 20 days. Participants~          will have blood drawn and transvaginal ultrasound daily or every other day. Some~          participants will also have blood thinner injected daily.~        -  Egg retrieval: participants will check in to the hospital. Eggs will be removed with a~          needle during a short surgery. Participants will be awake but sedated.~        -  Participants may stay overnight in the hospital.~        -  They will return every 1 3 days for 1 3 weeks for blood tests.~        -  Mature eggs will be frozen after egg retrieval and immature eggs (which cannot be~          fertilized for clinical use) will be used for research. Participants can use their eggs~          in the future at outside, private fertility clinics to try to become pregnant. If the~          eggs are stored for more than 5 years, participants must pay for storage.~   "
102543|NCT02225132|"~     Background:~      - Sickle cell disease (SCD) is a blood disease. The drug hydroxyurea (HU) is approved to~     prevent pain crises in people with SCD. Researchers want to see how higher doses of HU affect~     the blood. This will help them learn about the right dosage of HU to give to people with SCD.~      Objective:~      - To improve hydroxyurea dosing in people with SCD.~      Eligibility:~      - People age 15 or older with homozygous SCD (HbSS).~      Design:~        -  Participants will be screened with medical history, physical exam, medication review,~          and blood and urine tests.~        -  Participants will be in the study for about 15 months.~        -  First 3 months: monthly study visits with blood and urine tests.~        -  After 3 months: participants will take HU as a capsule by mouth. If you are already~          taking HU, your dose will be increased.~        -  Within a month of starting or increasing HU: participants will keep a daily pain diary~          for 2 weeks. They will have an echocardiogram (ultrasound) of the heart, a 6-minute walk~          test. They will complete a quality-of-life questionnaire.~        -  Participants will visit every month until they reach their highest tolerated dose of HU.~          They may need to come as often as every week sometimes to closely monitor their blood~          counts. Then they will alternate a phone call one month and a visit the next. At the~          visits, participants will bring their pill bottle, answer questions about side effects,~          and have blood tests.~        -  Every 2 months, participants will have a medical history, physical exam, and blood~          tests.~        -  Every 4 months, participants will have blood and urine tests. They will also complete~          another 2-week pain diary and quality-of-life questionnaire.~        -  About 12 months after starting or increasing HU, participants will have blood tests, an~          echocardiogram, and a 6-minute walk test.~   "
102544|NCT02225119|"~     Background:~      - Maculopathies are eye conditions that affect the center of the retina. Retina health~     depends on the RPE, a layer behind the retina. A new test may measure the health of the~     central retina and RPE.~      Objective:~      - To use the focal electro-oculogram test to understand how the central retina and RPE are~     affected in maculopathies.~      Eligibility:~        -  People at least 10 years old with a maculopathy.~        -  Healthy volunteers.~      Design:~        -  Participants will be screened with medical and eye history and an eye exam. Pictures~          will be taken of the eyes.~        -  Their eyes may be dilated.~        -  They may have a field test. They will look into a lens and press a button when they see~          a light. First, they may sit in the dark for 40 minutes.~        -  Participants will have 1 7 visits over 18 months.~        -  Their vision will be tested and eye pressure measured.~        -  Their pupils will be dilated with eye drops and researchers may take pictures of the~          retina and the inside of the eye, and measure the thickness of the retina.~        -  Participants will have an electro-oculogram. They will look at a 2 LED lights and follow~          them back and forth for 10 seconds once per minute. Participants will be in darkness for~          15 minutes and in light for 20 minutes. One skin electrode will be placed on the nose~          and one next to the eye.~        -  Participants with maculopathy will also have:~        -  Field test.~        -  Electroretinogram. Participants will get numbing eye drops and special contact lenses. A~          small metal electrode will be taped to the forehead. Participants will watch flashing~          lights and try not to blink. First, they may sit in the dark for 40 minutes.~   "
102545|NCT02225106|"~     OBJECTIVES:~      Deficits in memory, attention, cognitive, and executive functions are the most common~     disabilities after traumatic brain injury (TBI). Dopamine (DA) neurotransmission is~     implicated in these neural functions and dopaminergic pathways are recognized to be~     frequently disrupted after TBI. One of the most widely used DAergic drugs is methylphenidate~     (Ritalin ). Methylphenidate increases synaptic DA levels by binding to presynaptic dopamine~     transporters (DAT) and blocking re-uptake. PET with methylphenidate challenge to measure~     tonic DA release provides valuable insight into the molecular basis of attention-deficit~     hyperactivity disorder (ADHD) and addiction, as well as practical information regarding~     likely effectiveness of therapy (1). The objectives of this study are to use PET imaging with~     [11C]-raclopride, a D2/D3 receptor ligand, before and after administering methylphenidate, to~     measure endogenous DA release in patients who are experiencing problems with cognition,~     attention and executive function in the chronic stage after TBI. In addition, we will use TMS~     to test short intracortical inhibition, a gamma-aminobutyric acid receptor A (GABAA) -~     mediated phenomenon, which is under partial DA control, as a measure of dopaminergic activity~     on and off~      methylphenidate.~      STUDY POPULATION:~      Males and females (n=30), between the ages of 18 and 55 years in the chronic stage after TBI~     who experience deficits in neuropsychological function from TBIs incurred 6 months after the~     injury, will be recruited from military treatment facilities or civilian clinics when~     presenting for clinical management of TBI or postconcussive symptoms.~      DESIGN:~        1. Study participants will be evaluated using brain MRI, psychometric measures adapted from~          the TBI Common Data Elements, attention tests and information about details of the~          injury and experience of post-concussive symptoms will be recorded. Transcranial~          magnetic stimulation (TMS) with placebo and with methylphenidate (60 mg by mouth)~          challenge will be performed to predict a stimulant response.~        2. Subjects will be studied with [11C]-raclopride PET in two imaging sessions. One session~          will be after administration of placebo and the other after methylphenidate, 60 mg by~          mouth. Both placebo and methylphenidate will be given 60 minutes prior to injection of~          [11C]-raclopride to allow for peak uptake of methylphenidate in the brain. The binding~          potential of [11C]-raclopride relative to a non-displaceable reference region~          (cerebellum), BPND, will be used as a measure of D2/D3 receptor availability. The~          difference in BPND between methylphenidate and placebo ( BPND) is used to measure of~          tonic DA release.~        3. Subjects will then be treated with oral methylphenidate, using a forced titration up to~          a dose of 30 mg given twice daily for 4 weeks. At that point, the neuropsychologic tests~          are repeated.~      OUTCOME MEASURES:~      The primary outcome is change in information processing speed~      during neuropsychologic testing~   "
102546|NCT02225093|"~     This study evaluates how once daily enzalutamide affects the metabolism of caffeine and~     dextromethorphan in men with prostate cancer by measuring concentrations of these drugs and~     their metabolites in plasma.~   "
102547|NCT02225080|"~     The purpose of this study is to gather information about post-market performance of DuraGen~     Secure.The aim of this post market clinical follow-up (PMCF) is to obtain post market~     clinical data to evaluate the presence of unintended residual risks associated with the use~     of DuraGen Secure that were not anticipated or identified in the animal studies, bench~     studies or clinical evaluation report.~   "
102548|NCT02225067|"~     The purpose of this study is to compare C13-CAC Breath Test with 24-hour Gastric pH~     Monitoring in Patients with Gastric Acid-related Diseases and Healthy Volunteers~   "
102549|NCT02225054|"~     The purpose of this study is to determine whether a small dose of Dexmedetomidine, when given~     either intravenously or as part of the interscalene nerve block solution, prolongs pain~     relief following shoulder surgery compared to local anesthetic solution alone.~   "
102565|NCT02224846|"~     The purpose of this study is to evaluate the safety and effectiveness of the study drug,~     taken once daily, known as tadalafil in Chinese participants with erectile dysfunction (ED).~     The study will last about up to 25 months for each participant.~   "
102550|NCT02225041|"~     The purpose of this study is to determine the relationships between sedative exposure during~     pediatric critical illness and long-term neurocognitive outcomes. We will test for drug- and~     dose-dependent relationships between sedative exposure and neurocognitive outcomes along the~     early developmental spectrum and will control for baseline and environmental factors, as well~     as the severity and course of illness.~      Hypotheses:~        1. Greater exposure to benzodiazepines and/or ketamine will be associated with lower IQ~          even when controlling for severity of illness, hospital course, and baseline factors. In~          addition, benzodiazepines and/or ketamine will negatively affect other aspects of~          neurocognitive function.~        2. Younger children exposed to benzodiazepines and/or ketamine will have worse~          neurocognitive outcomes than older children with similar sedative exposure and severity~          of illness.~   "
102551|NCT02225028|"~     People with spinal cord injuries (SCI) are among the least physically active groups in our~     society. Approximately 1 in 4 healthy young persons with spinal cord injury (SCI) does not~     have sufficient fitness to perform many essential activities of daily living. About 50% of~     people with SCI engage in no leisure time physical activity. That is, they do not wheel or~     walk for pleasure, don't play a sport, don't exercise at home or go to a gym. As a result of~     this, cardiovascular, endocrine and metabolic conditions adversely affect the health of a~     large segment of the SCI population. Fortunately, clinic and/or laboratory-based aerobic~     conditioning and circuit training studies provide compelling evidence that people with SCI~     can improve their cardiorespiratory fitness and by doing so can partially reverse~     cardiovascular disease (CVD) risk factors, enhance Quality of Life (QOL) and improve elements~     of subjective well-being. While intensive, clinic-based, supervised exercise programs can~     improve the fitness and health of persons with SCI, the value of these findings for the SCI~     population is limited because the vast majority of people do not have access to these~     specialized programs and facilities. The gap that the present study addresses is: How can we~     extend the benefits of increased exercise and physical activity to more people with SCI?~      The goal of this study is to evaluate the feasibility of an individually tailored, home- or~     community-based, telephone delivered intervention that uses evidence-based behavioral and~     motivational counseling to increase daily physical activity and exercise.~   "
102552|NCT02225015|"~     This study aims to develop a follow-up telephone-based genetic counselling (FTGC)~     intervention for women with a BRCA1 or BRCA2 mutation who have received genetic counseling in~     the past. Typically, when women undergo genetic testing, they receive standard genetic~     counselling prior to testing in order to fully understand the procedure and associated~     implications. If a woman's genetic test results are positive for a mutation, cancer~     prevention options are then discussed with a counsellor. However, in Canada, there is~     currently no formal follow-up counselling for women with a BRCA mutation to provide ongoing~     guidance and support about latest risk reduction strategies. Standard care relies on women~     making contact for any follow-up questions or concerns they may have. As a result, these~     women might not have the most current information regarding genetic risk assessment and~     prevention options. Therefore, individuals are being asked to participate in this study to~     aid research about the efficacy of FTGC in women with a BRCA mutation.~   "
102553|NCT02225002|"~     CD40, a member of the Tumor Necrosis Factor receptor superfamily, is expressed on many tumor~     types, including melanoma, prostate, colon, breast, renal, pancreatic, and nonsmall cell lung~     cancers. In preclinical models, activation of CD40 results in increased antigen presentation~     and induction of apoptosis. CD40 is also expressed on antigen presenting cells (APCs) (B~     cells, dendritic cells, monocytes) and is a key regulator of both cellular and humoral immune~     responses. Activation of CD40 by CP-870,893, an agonistic anti-CD40 monoclonal antibody,~     enhances host immune responses and abrogates the growth of tumors independently of the~     expression of CD40 on tumor cells. Therefore, it is hypothesized that therapeutic~     intervention with CP-870,893 may be beneficial to a large number of cancer patients either~     through an immunomodulatory effect or through a direct effect on CD40-positive tumor cells.~   "
102554|NCT02224989|"~     This pilot project evaluates the efficacy of a mind-body awareness training intervention,~     Mind-Body Bridging (MBB), in veteran patients with PTSD and comorbid symptoms. Evidence for~     relative therapeutic benefit will be indicated by the difference in outcomes from pre- to~     post-intervention for PTSD as the primary outcome.~   "
102555|NCT02224976|"~     The investigators propose a prospective, longitudinal, department funded study protocol to~     evaluate whether changes in energy availability, during a period of highly intensified~     exercise training, will increase bone turnover markers and decrease ovarian function and~     exercise performance, in a dose-dependent fashion in competitive female athletes.~   "
102556|NCT02224963|"~     The purpose of this randomized trial is to examine the effectiveness of a psycho-social~     Preventive Problem Solving Intervention on emotional well-being, change in future outlook,~     and vision functioning in 250 Age-related Macular Degeneration patients 60 and older.~   "
102557|NCT02224950|"~     The study will primarily focus on evaluating the benefits of using a~     lyocell/chitosan/ceramide fabric as a treatment for young children with mild or moderate~     eczema. More specifically, the study will focus on the upper limb area in these patients and~     will examine whether wearing a sleeve made from a lyocell/chitosan/ceramide fabric can~     improve eczema symptoms compared with wearing a cotton sleeve, no sleeve, or the lyocell /~     chitosan combination. Patients will be evaluated at 3 intervals over a 3-week period using~     the following four variables: an eczema severity index, amount of itching, bacteria levels in~     the affected areas of skin, and amount of water loss in the affected areas.~   "
102558|NCT02224937|"~     The purpose of this study is to evaluate the percutaneous transportation and pharmacokinetics~     of melatonincream 12,5% when used on 80% of the body area. A test battery consisting of~     blood, saliva, urine samples at 1,2,3,4,5,6,7,8,12,24 and 36 hours after cream application.~     Cognitive parameters are investigated using KSS, FTT and CRT tests at above mentioned time~     points.~   "
102559|NCT02224924|"~     The purpose of this study is to compare two methods that are currently used at the end of a~     CT guided lung biopsy to close the hole on the surface of the lung in order to minimize the~     chance of air leaking out of the hole. The two techniques consist of either injecting a very~     small amount of your the blood called a blood patch into the biopsy hole or injecting a~     gel-based FDA approved artificial plug called BioSentry that will eventually get absorbed~     into the body.~   "
102566|NCT02224833|"~     PHARM-PC study is based on identify potentially inappropriate prescriptions (PIP) and~     delivery therapeutic appropriateness recommendations from the pharmacist to the physician and~     about drugs prescribed for elderly and polypharmacy patients in primary care. Assessment of~     the impact of pharmacist intervention on the appropriateness of prescribing and both health~     outcomes and economic outcomes will be done.~   "
102567|NCT02224820|"~     IdeS is an immunoglobulin g (IgG) cleaving enzyme. It will given to patients with donor~     specific antibodies to reduce the antibody load and thus enable kidney transplantation. IdeS~     antibody reducing efficacy and its safety will be studied.~   "
102568|NCT02224807|"~     This pilot/feasibility trial seeks to explore whether an acute bout of negative energy~     balance prior to surgery affects biomarkers of neoplasia. Forty overweight or obese~     postmenopausal women diagnosed with ductal carcinoma in situ (DCIS) or early stage breast~     cancer (Stage I or II) who elect mastectomy or lumpectomy will be randomly assigned to 1-of-2~     study arms: 1) an Attention Control Group that receives instruction on dietary approaches to~     correct nutritional deficiencies and progressive resistance training (PRT) that targets the~     arm ipsilateral to the affected breast; or 2) an Experimental Group that will receive PRT and~     guidance to correct nutritional deficiencies plus an intensive intervention to promote a~     1.5-2 pound/week weight loss through diet, exercise, and behavior modification. This study~     will explore and contrast changes in body mass index (BMI) observed from enrollment to the~     time of surgery in the experimental vs. attention control arms, and also monitor changes in~     energy intake and physical activity. These changes will be studied in relation to the~     following endpoints: a) changes in select circulating biomarkers and gene expression related~     to cancer progression, hormonal status, inflammation and other energy-related factors; b)~     rates of tumor proliferation and apoptosis; c) tumor markers, e.g., insulin receptor,~     Vascular Epithelial Growth Factor (VEGF), Nuclear Factor kappa beta (NFkB), and~     phosphoproteins associated with the Convergence of Hormones, Inflammation and Energy-Rated~     Factors (CHIEF) pathway; and d) functional and health-related outcomes. Because both tumor~     tissue and blood will be examined from pre-to-post-intervention, this study will provide~     exciting new data that can elucidate pathways by which energy balance affects breast cancer~     progression. Although longer term weight loss is recommended for overweight and obese breast~     cancer survivors, it is not known whether placing the body in a state of negative energy~     balance will have a favorable impact on the tumor. If beneficial changes in tumor biology and~     the host environment occur with short-term, pre-surgical weight loss, this study provides~     proof of concept that weight loss may offer an acceptable and complementary treatment option~     that could be combined with standard therapies.~   "
102569|NCT02224794|"~     The primary objectives of the LIFE Study are to demonstrate the clinical and cost benefits~     associated with using the Ovation® Abdominal Stent Graft Platform under the least invasive~     conditions defined in the Fast-Track EVAR protocol. The key elements of the Fast-Track EVAR~     protocol include: appropriate patient selection, bilateral percutaneous access, no general~     anesthesia, no ICU admission post procedure, and next day discharge.~   "
102570|NCT02224781|"~     This randomized phase III trial studies how well initial treatment with ipilimumab and~     nivolumab followed by dabrafenib and trametinib works and compares it to initial treatment~     with dabrafenib and trametinib followed by ipilimumab and nivolumab in treating patients with~     stage III-IV melanoma that contains a mutation known as BRAFV600 and cannot be removed by~     surgery. Ipilimumab and nivolumab may block tumor growth by targeting certain cells.~     Dabrafenib and trametinib may block tumor growth by targeting the BRAFV600 gene. It is not~     yet known whether treating patients with ipilimumab and nivolumab followed by dabrafenib and~     trametinib is more effective than treatment with dabrafenib and trametinib followed by~     ipilimumab and nivolumab.~   "
102571|NCT02224768|"~     To evaluate the effectiveness of the YERVOY® educational Risk Minimization (RM) tools in~     terms of awareness about these tools, their utilization, knowledge and comprehension of~     Immune Related Adverse Reaction (irAR)s, and appropriate behavior by Healthcare Professional~     (HCP)s and patients~   "
102572|NCT02224755|"~     The objective of the study is to evaluate the safety and effectiveness of the HM3 LVAS by~     demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of~     advanced, refractory, left ventricular heart failure.~   "
102573|NCT02224742|"~     Diabetic foot ulcers are the source of considerable suffering and cost and there are~     currently no wound care products available that have been demonstrated to improve healing, or~     that are cost effective. There have however been a small number of studies which have~     examined the use of platelets or fluid derived from platelets, either from the patient's own~     blood or from blood bank products. These have suggested some promise, but have suffered from~     technical difficulties in making a suitable wound care product or the volume of blood~     required to derive the product. It is thought that the reason why they may work is that~     growth factors released by the platelets may stimulate the wound to heal.~      This study will be a formal, randomised controlled trial to assess a new device for creating~     a wound care product which is a plug or patch comprising fibrin, white cells and platelets~     derived from 18 mls of the patients own blood. The application of this fibrin/white~     cell/platelet patch to the patients wound on a weekly basis will be compared with usual best~     care in patients with hard to heal Diabetic Foot Ulcers in a secondary care setting in 25~     centres in the United Kingdom, Denmark and Sweden.~   "
102574|NCT02224729|"~     This phase II trial studies side effects and how well bendamustine hydrochloride, bortezomib,~     and dexamethasone work in treating patients with newly diagnosed multiple myeloma. Drugs used~     in chemotherapy, such as bendamustine hydrochloride and dexamethasone, work in different ways~     to stop the growth of cancer cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Bortezomib may stop the growth of cancer cells~     by blocking some of the enzymes needed for cell growth. Giving bendamustine hydrochloride~     with bortezomib and dexamethasone may kill more cancer cells.~   "
102575|NCT02224716|"~     The purpose of this study is to evaluate the impact of a structured package (bundle) in~     reducing the use of antimicrobials and hospital stay of patients with community-acquired~     pneumonia (CAP), and no increase in mortality of these patients in different hospitals.~   "
102576|NCT02224703|"~     To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children~     and young adults with Dravet syndrome.~   "
102577|NCT02224690|"~     To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in subjects~     with Lennox-Gastaut syndrome.~   "
102620|NCT02224131|"~     Patients' responses to oral antiplatelet therapy are subject to variation. Bedside monitoring~     offers the opportunity to improve outcomes of intracranial aneurysm patients undergoing stent~     deployment by individualizing therapy.This trial is designed to demonstrate the superiority~     of a strategy of platelet function monitoring with dose adjustment in suboptimal responders~     as compared to a more conventional strategy without monitoring and without dose adjustment to~     reduce the primary end point evaluated 6 months after stent deployment in patients with~     intracranial aneurysms.~   "
102578|NCT02224677|"~     This study is a multi-center, longitudinal cohort study of 125 infants with craniofacial~     microsomia (CFM) and 100 infants without craniofacial anomalies. Participants will undergo a~     series of evaluations between 0-3 years of age to comprehensively evaluate the developmental~     status of infants and toddlers with CFM. This research design will also explore specific~     pathways by which CFM may lead to certain outcomes. Specifically, the study explores (1) the~     longitudinal relations between facial asymmetry and emotion-related facial movements and~     socialization; and (2) associations among ear malformations, hearing and speech deficits and~     cognitive outcomes. Results of this research will ultimately lead to future investigations~     that assess new interventions and corresponding changes in current standards of care for~     children with CFM.~   "
102579|NCT02224664|"~     This study will be an open label, dose escalation study to investigate the safety,~     tolerability, pharmacokinetics and pharmacodynamics of repeated daily quaque die (QD) doses~     given over 21 days (Day 3 to Day 23) to sequential cohorts of subjects with Parkinson's~     disease. Each cohort will have 2 study periods. For each cohort, subjects will enter Period 1~     and if they meet criteria, approximately 12 subjects will be enrolled into Period 2 and dosed~     with PF 06649751. Based on results observed in a previous study, Cohorts 1 and 2 will not be~     conducted. Cohorts 3 - 6 will test doses uptitrated to 5 mg, 15 mg and 25 mg QD. Doses may be~     modified based on emerging safety, tolerability and PK data, but the maximum daily dose that~     will be given in any cohort will have PK predictions at steady state that are anticipated to~     be below toxicokinetic limits. An option for down titration to the previous dose level is~     available should the investigator consider that an AE is intolerable. Following down~     titration, a single up titration to the next dose level may be attempted if the subject~     remains symptom free for at least 48 hrs. Safety, tolerability and PK data of Cohort 3 will~     be reviewed prior to initiating the dosing in Cohorts 4 and 5. Available safety, tolerability~     and PK data up to Day 24 of at least 5 subjects from Cohorts 4 will be reviewed prior to~     initiating the dosing in Cohort 6.~   "
102580|NCT02224651|"~     This single ascending dose study is the first evaluation of PF-06650833 in humans. The goals~     are to assess the safety, tolerability and blood levels of ascending doses of multiple~     formulations of PF-06650833 and to perform a preliminary assessment of the effect of food on~     exposure, in healthy subjects.~   "
102581|NCT02224638|"~     Evaluation of a wound care debridement product and a moisturizer on sacral pressure ulcer~     wounds~   "
102582|NCT02224625|"~     Evaluating the irritation properties of CHG cloth. Some Subjects will also have the product~     applied to see if they become sensitized to repeated applications.~   "
102583|NCT02224612|"~     Compare the fit of two pediatric face masks in children.~   "
102584|NCT02224599|"~     Patients diagnosed with progressive and/or refractory solid malignancies (SM), who have~     failed conventional therapy, and have no available, potentially curative therapeutic options,~     will be candidates for this Phase I/II study. Following confirmation of disease progression~     and/or refractoriness, eligible patients who agree to participate and sign a consent form~     will have their tumor cells/tissues and/or blood analyzed for the expression of a specific~     panel of Tumor Associated Peptide Antigens (TAPAs), including Sp17, ropporin, AKAP-4, PTTG1,~     Span-xb, Her-2/neu, HM1.24, NY-ESO-1 and MAGE-1.~   "
102585|NCT02224586|"~     It is just an observation study. The investigates want to explore the signal changes of~     resting state functional Magnetic resonance Imaging (fMRI) after light treatment in jaundice~     infants. Signal changes contain blood oxygenation level dependent (BOLD) and arterial spin~     labeling (ASL).Indicator of BOLD is amplitude of low-frequency fluctuation（ALFF).Indicator of~     ASL is cerebral blood flow (CBF).~      The investigates assume that the children with jaundice after light therapy, ALFF and CBF~     will change. Focus on the globus pallidus and subthalamic nuclei. The two brain regions were~     proved to be abnormal in MRI T1, T2 structure signal in kernicterus.~      Doctors observe the status of infants aside.Using monitoring probe can see clearly.~   "
102586|NCT02224573|"~     To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children~     and young adults with Dravet or Lennox-Gastaut syndromes.~   "
102587|NCT02224560|"~     To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in subjects~     with Lennox-Gastaut syndrome.~   "
102588|NCT02224547|"~     The purpose of this study is to perform prospective data analysis on tumor response in terms~     of local tumor control after 2 years, potential acute and late toxicity and survival in~     patients with non-metastatic, non-small-cell lung cancer treated by radiotherapy that are~     medically inoperable due to coexisting comorbidities or that refuse surgery. SBRT regimens~     used will be 4 fractions of 12 Gy or 3 fractions of 17 Gy depending on tumor location in a~     risk-adapted approach.~   "
102589|NCT02224534|"~     The purpose of the study is to evaluate the novel role of ticagrelor to improve long-term LV~     remodeling following ST-segment elevation myocardial infarction.~   "
102590|NCT02224521|"~     GSK2190915 is a high affinity 5-lipoxygenase-activating protein (FLAP) inhibitor that reduces~     inflammation in cells.~      This study will evaluate three capsule and two tablet formulations to select the optimal~     formulation for further development. Safety will be assessed through clinical laboratory~     testing, 12-lead electrocardiogram (ECG), vital signs and Adverse Event/ Serious Adverse~     Event (AE/ SAE) recording.~   "
102591|NCT02224508|"~     Background: Sixty million American adults suffer from moderate to severe chronic pain. Of~     these, 5 to 8 million currently use opioids long-term. With increased opioid prescribing for~     chronic pain, an epidemic of prescription opioid addiction and overdose has arisen. This~     necessitates action to stem opioid-related morbidity and mortality. Group Health (GH), a~     large nonprofit health plan, developed and implemented opioid risk reduction strategies for~     doctors and patients in some, but not all, of its clinics. The risk reduction initiative~     achieved large opioid dose reductions, near universal documentation of care plans, and marked~     increases in patient monitoring. Rigorous evaluation of patient outcomes resulting from the~     opioid risk reduction initiative, incorporating patient perspectives, is needed to guide~     health care improvement efforts to reduce opioid risks regionally and nationally.~      Research goal: The investigators will evaluate a major health plan initiative to reduce risks~     of long-term opioid use for chronic pain. Starting in 2008, some GH clinics reduced~     prescribing of high opioid doses. In 2010 the same clinics increased care planning and~     monitoring of chronic opioid therapy (COT) patients. Our research goal is to evaluate effects~     of this initiative on health and safety outcomes of COT patients. We will test whether the~     initiative influenced pain outcomes; patient-reported opioid benefits and problems; and~     opioid-related adverse events.~      Design and Outcomes: The investigators will assess effects of GH's opioid risk reduction~     initiative among COT patients using opioids long-term. The investigators will compare COT~     patients from clinics that implemented the initiative with COT patients from care settings~     that did not implement the initiative. The investigators will use survey data to assess~     patient-reported outcomes including pain severity, depressive symptoms, and patient~     perceptions of opioid benefits and problems, including validated measures of prescription~     opioid use disorder. They will interview and compare 800 COT patients using opioids long-term~     from clinics that implemented the risk reduction initiative and 800 COT patients from care~     settings that did not.~      Impact: This research will provide an urgently needed, rigorous evaluation of a major risk~     reduction initiative among COT patients. Evaluation results will guide efforts of health~     plans, clinicians and patients nationwide to ensure safe, effective and compassionate chronic~     pain care.~   "
102592|NCT02224495|"~     Exercise training, as part of cardiac rehabilitation, is effective in improving functional~     capacity and quality of life in patients with coronary artery disease. Other cardiovascular~     and non-cardiovascular benefits have been reported, namely in glucose metabolism, skeletal~     muscle function, oxidative stress, vascular function, pulmonary circulation,~     ischaemia-reperfusion lesion and ventricular remodelling.~      However, the benefit of exercise training on systolic and diastolic function is controversial~     especially after acute myocardial infarction where no longitudinal study has evaluated~     diastolic function using modern echocardiographic parameters.~      The hypothesis is that a structured program of exercise training can improve systolic and~     diastolic function in patients after myocardial infarction.~   "
102593|NCT02224482|"~     The purpose of this study is to test how well an online program designed to help prostate~     cancer survivors cope with changes caused by their cancer or treatment works compared to~     standard print educational materials from the National Cancer Institute (NCI).~   "
102594|NCT02224469|"~     In this study a new means of communication for people with locked-in syndrome will be tested.~     The investigators will record brain signals directly from the surface of the brain by means~     of a completely implantable system. These brain signals are fed wirelessly into an assistive~     technology device and will control this device for communication and environmental control at~     the users home.~   "
102595|NCT02224456|"~     Chronic Hepatitis B infection (CHB) is known as the most frequently identified cause of liver~     disease that predisposes patients to the development of hepatocellular carcinoma (HCC).~     Active hepatitis B virus (HBV) replication is the key driver of liver injury and disease~     progression. Majority of Chinese patients are infected with genotype B and C HBV, which is~     different from Caucasian counterparts. This prospective multi-center cohort open-label study~     is designed to investigate the long-term effect of TDF on prevention of HCC and disease~     progression as well as to evaluate the efficacy and safety of long-term TDF in Chinese CHB~     subjects with advanced liver diseases. The study will enrol 240 subjects.~   "
102596|NCT02224443|"~     The purpose of this study is to identify the effects of different doses of dexmedetomidine on~     postoperative cognitive dysfunction in elderly hypertensive patients~   "
102597|NCT02224430|"~     This study is dedicated to achieving a better understanding of how to identify patterns that~     indicate someone might be at high risk for relapse in schizophrenia or schizoaffective~     disorder. The investigators are utilizing smartphone technology along with on body sensors to~     achieve this goal. The study will observe participants behavior in their natural environment~     for a period of 16 weeks or until a signal of relapse is obtained. Participants will also~     complete scales in a clinical research environment biweekly.~   "
102598|NCT02224417|"~     Type II diabetes is associated with a host of adverse and costly complications, including~     heart attacks, strokes, blindness, kidney failure, and severe neuropathy that may result in~     amputations. For those with diabetes, glycemic control is essential to minimize complications~     but many fail at being sufficiently adherent to their treatment. The investigators propose to~     test two incentive-based intervention strategies aimed at improving diabetes outcomes amongst~     patients with uncontrolled glycemic levels. The incentives are tied either to processes aimed~     at improving blood sugar levels (glucose testing, physical activity and medication adherence)~     or directly to the intermediary outcome (blood glucose in the acceptable range). While~     process incentives are likely to provide more motivation for treatment adherence, as these~     goals may be comparably easier to meet, these incentives only reward intermediary outcomes~     and it might be more effective to reward successfully achieving a health outcome directly.~   "
102599|NCT02224404|"~     The primary objective of this post market clinical follow-up (PMCF) investigation is to~     evaluate performance and safety of Exufiber when used as intended in Stage II-IV pressure~     ulcers (PU).~   "
102600|NCT02224391|"~     The goal of this research study is to learn if a smartphone-delivered intervention combined~     with nicotine replacement therapy can help you to quit smoking.~      This is an investigational study. The nicotine patch used in this study is FDA approved and~     commercially available.~      Up to 750 participants will be screened, and up to 250 eligible participants will take part~     in the study. All will be enrolled at MD Anderson.~   "
102601|NCT02224378|"~     Dynamic indices of preload depending on the heart-lung interaction require sinus rhythm and~     cannot be applied to patients with atrial fibrillation. PEEP-induced increase in central~     venous pressure (CVP) was shown to be a valid predictor of fluid responsiveness after cardiac~     surgery in patients with sinus rhythm, and was speculated to be of value in patients with~     rhythm other than sinus. The aim of this study is to assess the predictability of~     PEEP-induced increase in CVP and passive leg raising (PLR)-induced changes in stroke volume~     index (SVI) on fluid responsiveness in patients with atrial fibrillation following valvular~     heart surgery.~   "
102602|NCT02224365|"~     The hypothesis of this study is that the daily consumption of 75 g dried apple powder for~     twelve weeks will improve arterial stiffness and blood pressure by improving~     endothelial-mediated vasodilation and vascular sympathetic activity and favorably altering~     biochemical markers associated with cardiovascular risk and glycemic control compared to a~     macronutrient-matched control powder. 50 men and women between the ages of 45 and 65 with~     prediabetes or type 2 diabetes who are overweight or obese will be included in the study.~     After a two-week run-in phase, eligible men and women will be randomly assigned to one of two~     treatment groups: 1) 75 g dried apple powder; or 2) 75 g placebo powder daily for twelve~     weeks. After an initial telephone screening, all participants will be requested to report to~     the study site for their first visit. On the first visit (screening), participants will be~     provided with verbal and written explanation of the project. They will then be asked to sign~     an informed consent form, followed by measuring fasting glucose levels and a medical history~     questionnaire to confirm prediabetes or type 2 diabetes. Baseline assessments will be~     performed for medical history, medication use, dietary intake, and physical activity.~     Qualified participants will be scheduled for their second visit two weeks later (actual~     baseline data collection) and randomly assigned to their treatment group. On the second~     (baseline) visit between the hours of 6:00-11:00 A.M., blood pressure and vascular function~     will be measured followed by blood draw and urine collection. Anthropometrics will be~     measured. Participants will be provided with their assigned treatment and will receive~     standard instructions on how to fill out daily diaries for their treatment, and for food and~     physical activity records. Blood pressure, vascular function, blood draw, urine collection,~     and anthropometric, body composition, diet, and physical activity assessments will be~     repeated at 6- (third visit), and 12-week (final visit) intervals. All cardiovascular~     measurements will be performed between 6:00 to 11:00 A.M., in a quiet temperature-controlled~     room in the supine position after an overnight fast and 12 hours after the abstinence of~     caffeine and/or 24 hours after the last bout of moderate to heavy physical activity.~   "
102668|NCT02223494|"~     Study to assess the safety of terbogrel during open-label, long-term treatment in medically~     stable or improving patients with primary pulmonary hypertension who have completed the~     12-week, double-blind randomized trial of terbogrel (protocol 528.19)~   "
102669|NCT02223481|"~     This study sought to determine whether terbogrel was an effective treatment for primary~     pulmonary hypertension (PPH) by comparing its efficacy and safety to that of placebo.~   "
102603|NCT02224352|"~     Background: Over one million patients in the US are estimated to undergo mechanical~     ventilation every year, and approximately 300,000 of them fail attempts at weaning. The~     morbidity and mortality of these patients is greater than in patients who are successfully~     weaned. It follows that treatments aimed at reducing the duration of mechanical ventilation~     have the potential to benefit society both in terms of human suffering and cost.~      Patients who fail attempts at weaning assist their inspiratory muscles during inhalation by~     recruiting their expiratory muscles during exhalation. Unfortunately, this recruitment occurs~     relatively late during a weaning trial. The knowledge that (a) expiratory muscle recruitment~     can assist inspiration, (b) the recruitment of the expiratory muscles is delayed during~     weaning, and (c) that the respiratory muscles in patients requiring mechanical ventilation~     are in a catabolic state raises the possibility that strategies designed to produce an early~     recruitment, and improve the strength, of the expiratory muscles could improve weaning~     outcomes in difficult to wean patients.~      The current investigation, which will be conducted in healthy subjects and in ambulatory~     patients with chronic obstructive pulmonary disease (COPD) at Edward Hines Jr. VAH (Aims 1~     and 2), and in patients who are difficult to wean from mechanical ventilation at RML~     Specialty Hospital, Hinsdale, IL (Aim 3), has been designed to develop and assess a novel~     triggering algorithm (VentFree), that controls the delivery of non-invasive neuro muscular~     electrical stimulation (NMES) to the abdominal-wall muscles during exhalation, and to study~     the physiological (respiratory) responses to such stimulation in assisting respiration in~     healthy subjects, in ambulatory patients with COPD and in patients requiring pronged~     mechanical ventilation.~   "
102604|NCT02224339|"~     Hypothesis: Identification of vulnerable atherosclerotic plaques (with or without~     neovascularization) using carotid CEUS is an independent predictor of MACE (over clinical~     risk factors, stress echo wall motion results, and carotid ultrasound two-dimensional speckle~     tracking strain indices).~      Primary Aims:~        1. Evaluate the diagnostic role of carotid CEUS and two-dimensional speckle tracking strain~          imaging for detection of carotid plaque:~             -  To determine the feasibility and safety of Carotid CEUS and Two-dimensional speckle~               tracking strain imaging SE .~             -  To determine if carotid CEUS and two-dimensional speckle tracking strain imaging~               findings are associated with coronary angiographic results in those patients~               undergoing clinically indicated cardiac catheterization.~             -  To determine the diagnostic accuracy of CEUS in identifying a vulnerable~               atherosclerotic plaque and neovascularization compared to carotid MRI, in a subset~               of patients.~        2. Evaluate the prognostic role of carotid CEUS and two-dimensional speckle tracking strain~          imaging for prediction of MACE:~             -  To determine if plaque identification (with or without neovascularization) on~               Carotid CEUS SE can improve the overall prediction of MACE over stress echo results~               alone~             -  To determine if Carotid ultrasound two-dimensional speckle tracking strain indices~               can improve the overall prediction of MACE over stress echo results alone.~             -  To determine if the detection of plaque neovascularization by Carotid CEUS is an~               independent predictor of MACE (over clinical risk factors, stress echo wall motion~               results, and carotid ultrasound two-dimensional speckle tracking strain indices).~   "
102605|NCT02224326|"~     In its long preclinical course, AD shows a spreading pattern of specific pathology in a~     uniform sequence of predictable steps including brainstem nuclei in early stages. Many of~     these nuclei which are early involved in AD take equally part in the afferences of the Xth~     cranial nerve, the Vagus nerve. A method for the functional assessment of Vagus-related~     nuclei in the lower brainstem is the technique of somatosensory evoked potentials of the~     Vagus nerve (VSEP). This method targets the accessibility of early functional changes by~     evoked potentials on one hand and the early affection of specific brainstem nuclei comprising~     Vagus afferences in the course of AD on the other hand. The method of VSEP takes advantage of~     the transcutaneous stimulation of the auricular branch of the Vagus nerve (ABVN) which is~     presumed to be the only sensory part of this nerve innervating parts of the outer meatus~     acoustics at the tragus. This cutaneous branch was shown to gain access to Vagus afferences~     via brainstem regions which are affected in the course of AD. VSEP latencies in AD were shown~     to be significantly longer as compared to healthy controls. Yet, if VSEP really are suited~     for the early detection of AD is still not known.~      Functional near-infrared spectroscopy (fNIRS) measures changes in cerebral oxygenation by~     means of near-infrared light using wavelengths of 650-850 nm. The principle of fNIRS is based~     on the principle that regional neuronal activation of the brain leads to an increase in~     metabolism and oxygenation of brain tissue in that region which is accompanied by an elevated~     regional cerebral blood flow. In AD, there is a growing body of literature reporting deviant~     fNIRS activation patterns for a variety of tasks. For example, it was shown that the fNIRS~     activation pattern in frontal and parietal cortex areas in subjects with AD performing the~     line orientation paradigm is clearly different from healthy controls. Yet, if fNIRS is suited~     as a means of early detection of AD is not known.~      Therefore we aimed at testing the predictive value of VSEP and fNIRS in the early detection~     of AD. The hypothesis to be tested within this study states that subjects developing AD or~     MCI within an observation period of 6 years depict longer VSEP latencies, a different fNIRS~     oxygenation pattern and a lower performance in neuropsychologic rating below the level of~     dementia at baseline than those who remain cognitively stable.~   "
102606|NCT02224313|"~     The purpose of this study is to compare the vaginal health between premenopausal and~     postmenopausal women before and after using oral estradiol for 14 days then estradiol and~     progesterone for 14 days.~   "
102607|NCT02224300|"~     Aims are:~        -  develop an Internet-based education programme about venous leg ulcer nursing care (ELC)~        -  evaluate the clinical, cognitive and economical outcomes of education programme~      Research questions are:~      1. What are the cognitive outcomes of ELC (perceived knowledge, attitudes towards venous leg~     ulcer nursing care, theoretical knowledge level and practical knowledge)?~      Hypotheses for research question 1 are:~        1. Nurses using the ELC will have better knowledge (perceived, practical and theoretical~          knowledge) than those who will not use the ELC.~        2. Nurses using the ELC will have more positive attitudes towards venous leg ulcer nursing~          care than those who will not use the ELC.~      2. What are the clinical outcomes of ELC (ulcer healing, ulcer size, treatment supplies)?~      Hypotheses for research question 2 are:~        1. Ulcer healing progresses better among patients who are taken care by nurses using the~          ELC.~        2. Ulcer sizes will be 10 % smaller among the patients cared for nurses using the ELC.~        3. Nurses using the ELC will use mire adequate treatment supplies than those who will not~          use the ELC.~      3. What are the economical outcomes (treatment time and supply usage) of ELC?~      Hypothesis for research question 3 is:~      1. The economical expenditures will be lower among nurses using the ELC.~      The ultimate aim is to promote evidence-based nursing care among patients with venous leg~     ulcer.~   "
102608|NCT02224287|"~     This is a prospective randomized trial to study the effect of assigning the control of the~     fluoroscopic x-ray activation to the surgeon as compared to the radiation technologist.~     Radiation exposure will be assessed from the collected data, fluoroscopy time, and dose~     parameters (cumulative absorbed dose and dose area product). From exposure data, entrance~     skin dose (ESD) and midline absorbed dose (MLD) will be calculated. The primary outcome in~     this study will be total fluoroscopy time for the procedure. A secondary outcome will be the~     ESD. The investigators will further analyze the contribution of clinical predictors (e.g.~     stone size/location) and procedural predictors on fluoroscopy times and ESD.~      It is hypothesized that a 30% reduction in fluoroscopy time will occur when the operating~     surgeon is controlling the activation of the x-ray beam.~   "
117148|NCT02034136|"~     Aim : Investigated the effects of Korean red ginseng supplementation on metabolic parameters~     such as cholesterol, blood pressure and glucose.~      Randomized Control Trial.~   "
102609|NCT02224274|"~     There is growing evidence that standard dual antiplatelet therapy with acetylsalicylic acid~     (ASA) and clopidogrel is not as effective in the setting of therapeutic hypothermia after~     cardiac arrest as in normothermic patients. The reasons for this are probably slower~     gastrointestinal motility, absorption and liver metabolism required for clopidogrel to take~     action. Since ticagrelor has faster intestinal absorption and no need for liver metabolism we~     expect its effect to be good even in patients with therapeutic hypothermia after cardiac~     arrest. Patients treated with therapeutic hypothermia after cardiac arrest and percutaneous~     coronary intervention will be randomised into two groups. One will be treated with ASA and~     clopidogrel and the other with ASA and ticagrelor. Blood samples will be collected before and~     2, 4, 12, 22 and 48 hours after P2Y12 inhibitor administration. Platelet function will be~     measured by VerifyNow P2Y12 assay and by Multiplate ADPTest. Differences between the groups~     will be analysed.~      Hypothesis: Antiplatelet therapy with ticagrelor is more effective than therapy with~     clopidogrel in the comatose survivors of cardiac arrest treated with therapeutic hypothermia~     and percutaneous coronary intervention (PCI).~   "
102610|NCT02224261|"~     Objective: To determine the effectiveness of physical therapy on the axillary web syndrome in~     improving pain, reducing swelling and increasing mobility of the shoulder. Design: randomized~     single-blinded controlled trial. Follow-up: five physical therapy assessments:~     pre-intervention; post-intervention, 3 months post-intervention, 6 months post-intervention.~     Participants: Eighty consecutive women diagnosed with axillary web syndrome after undergoing~     unilateral breast cancer surgery with ALND or SLND at the Prıíncipe de Asturias Hospital in~     Alcalà de Henares, Madrid (Spain). Randomization: women will be randomly assigned to two~     groups by EpiData 3.1 software. Interventions: Physical Therapy group: Physical Therapy~     composed of manual lymph-drainage technique in axilla, and proximal ipsilateral arm, specific~     thumb manual lymph-drainage on the taut cords to make them gradually more flexible, in~     conjunction with progressive active and action-assisted arm exercises; Control group:~     progressive active and action-assisted arm exercises. 9 physical therapy sessions.~   "
102611|NCT02224248|"~     The purpose of this study is to investigate if including fitness testing in preventive health~     checks increase cardiorespiratory fitness and motivation to change physical activity behavior~     compared with preventive health checks without fitness testing.~   "
102612|NCT02224235|"~     Phase one of this study is a prospective, randomized (2:1), pilot study that will evaluate~     COBRA PzF vascular healing patterns and thrombus formation with Optical Coherence Tomography~     (OCT) at 3 months after stent implantation in comparison with Resolute Integrity drug eluting~     stent (DES). Patients in the COBRA PzF (Group 1) will receive dual anti platelets for one~     week followed by aspirin, while patients implanted with ZES (Group 2), will receive Dual~     anti-platelet therapy (DAPT) for at least 6 months followed by aspirin.~      After the completion of Phase 1, Phase 2 will enroll 10 patients in the COBRA PzF (Group 3).~     Patients in Group 3 will receive aspirin alone and have OCT at one month after the stent~     procedure to evaluate COBRA PzF vascular healing patterns and thrombus formation at one month~     follow up.~   "
102613|NCT02224222|"~     The purpose of this study is to assess the impact of frailty as a multidimensional risk~     factor on the outcomes of adult cardiac and vascular surgery. For the purpose of defining~     patient frailty a multimodal questionnaire has been developed including measurement of~     psychological, socioeconomical, neurological and behavioral aspects. This study also features~     an investigation of the possible relationship between sudden regional weather changes,~     individual meteorological susceptibility of the patients and the outcomes of adult cardiac~     and vascular surgery.~   "
102614|NCT02224209|"~     The purpose of this study is to evaluate the efficacy and safety of staged carotid~     angioplasty v.s. routine single-stage carotid artery stenting in Chinese patients with~     carotid artery stenosis at high hyperperfusion risk in peri-procedural period.~   "
102615|NCT02224196|"~     Comparison of peak airway pressure and gastric insufflation in manual ventilation and~     pressure-controlled ventilation with facemask during anesthesia induction in children.~   "
102616|NCT02224183|"~     Chronic low back pain (cLBP) is the most common pain condition in the military, causing~     substantial physical and psychological suffering, reduction in force readiness, and high~     economic cost. Yoga has been studied in 10 RCTs in civilian populations with cLBP suggesting~     it may be effective in reducing pain intensity, improving back-related function, and lowering~     pain medication use. Multiple differences exist between civilian and military populations~     with cLBP, making it necessary to adapt and test yoga for cLBP in military populations. This~     study's primary aim is to evaluate the effectiveness of yoga for reducing pain in military~     personnel and Veterans with cLBP through a structured, reproducible 12-week series of hatha~     yoga classes, supplemented with home practice, compared to an education group. Additionally,~     the enormous mental health burden often shouldered by returning military personnel presents~     another important distinguishing factor. Thus, the study's secondary aim is to assess yoga's~     capacity to reduce post-traumatic stress symptoms (PTSS). The third aim is to evaluate the~     cost-effectiveness of yoga for cLBP at 3 months and 6 months from the perspective of the~     provider, the Veteran, and the Veterans Health Administration. The fourth and final aim is to~     evaluate the effect of back pain and yoga on marital and family functioning. The proposed RCT~     will (1) establish a structured reproducible yoga protocol uniquely suited to Veterans~     populations with cLBP; (2) develop web-based delivery systems to assist Veterans in yoga home~     practice; (3) increase our knowledge of the feasibility and impact of yoga for Veterans' cLBP~     and psychological comorbidities. These results will help determine whether yoga is an~     effective modality for addressing cLBP in a Veteran population.~   "
102617|NCT02224170|"~     The primary purpose of this study is to compare the effect of lidocaine and dexamethasone on~     postoperative quality of recovery after laparoscopic cholecystectomy~   "
102618|NCT02224157|"~     The purpose of this study is to test if Symbicort (budesonide/formoterol) Turbuhaler is~     effective in treating asthma when used 'as needed' in patients with milder asthma. The~     efficacy of Symbicort 'as needed' will be compared with Pulmicort (budesonide) Turbuhaler~     twice daily plus terbutaline Turbuhaler 'as needed'~   "
102619|NCT02224144|"~     The purpose of this study is to test whether active vitamin D (calcitriol) protects bones~     from weakening and protects blood vessels from calcium deposits over the first year of kidney~     transplantation.~   "
102621|NCT02224118|"~     The purpose of this study is to investigate the safety (adverse events, weight, blood~     pressure, pulse rate, body temperature, abdominal ultrasonography, standard 12-lead~     electrocardiography, and laboratory tests) of CNTO 3649 when administered once by~     subcutaneous injection in healthy adult Japanese men or once a week for 4 weeks in Japanese~     participants with type 2 diabetes mellitus (disorder in which there is decreased insulin in~     the body or the body's insulin is not effective, resulting in high blood sugar, increased~     thirst and urine, and many other side effects).~   "
102622|NCT02224105|"~     The general aim of the current study was to investigate the safety and tolerability, and~     pharmacodynamics (endotoxin-induced inflammatory response of a single intravenous bolus~     administration of 2 ng/kg body weight Escherichia coli lipopolysaccharide (LPS)) of BI 653048~     BS H3PO4 capsules in healthy male subjects following oral administration of multiple rising~     doses of 25 mg to 200 mg over three days compared to the active comparator prednisolone and~     placebo.~      Pharmacodynamics were assessed by investigating the influence of LPS administration on~     inflammatory parameters. More specifically, it was evaluated whether and to what extent the~     symptoms induced by LPS challenge can be attenuated by ascending BI 653048 BS H3PO4 doses~     using prednisolone as positive control and placebo as negative control. A secondary objective~     was the exploration of pharmacokinetics of BI 653048 BS, the investigation of other~     pharmacodynamic parameters (biomarker) and of the tolerability of LPS.~   "
102623|NCT02224092|"~     The objectives of this exploratory study are to (1) evaluate the effect of the multivitamin~     multimineral with phytonutrient product vs. placebo on heart health risk factors following~     twice-daily consumption for eight weeks; (2) To test the safety and tolerability of the~     multivitamin multimineral with phytonutrient product vs. placebo following twice-daily~     consumption for eight weeks.~   "
102624|NCT02224079|"~     Study to assess safety, tolerability and pharmacokinetics (PK) of single intravenous (i.v.)~     doses of BIIB 722 CL~   "
102625|NCT02224066|"~     A high platelet reactivity in patients with severe symptomatic Aortic Stenosis (AS) selected~     for TAVI (Transcatheter aortic valve implantation) procedure has been demonstrated~     previously, and the use of double antiaggregation therapy (DAPT) with Clopidogrel and~     Acetylsalicylic acid (ASA) do not achieve consistent and adequate suppression of platelet~     reactivity. The purpose of this study is evaluate the efficacy of ticagrelor alone versus~     DAPT with clopidogrel and aspirin for the suppression of high platelet reactivity following~     TAVI.~   "
102626|NCT02224053|"~     This is a Phase 1, open-label, 2-period fixed sequence design to evaluate the interaction of~     AZD9291 with omeprazole in approximately 50 healthy, adult male volunteers. Volunteers will~     receive Treatment A (AZD9291 and omeprazole) in Period 1 and Treatment B (AZD9291 only) in~     Period 2. The dose of AZD9291 in Period 1 and the dose of AZD9291 in Period 2 will be~     separated by a washout of at least 21 days (the washout will not be more than 5 weeks). The~     study will be performed at up to 2 sites in the USA and will assess the effect of omeprazole~     (proton pump inhibitor) on AZD9291 exposure~   "
102627|NCT02224040|"~     The current study goal is to examine the effect of Cephalosporins, Azithromycin and the~     combination of both on typhoid fever therapy in endemic population.~      The investigator's hypothesize that the combination of azithromycin and ceftriaxone may prove~     superior to each drug, ceftriaxone or azithromycin, alone.~   "
102628|NCT02224027|"~     The use of laryngeal mask airway or i-gel to manage airway may improve success rates,~     especially in difficult situations more than tracheal intubation.~   "
102629|NCT02224014|"~     Study to investigate the safety and the efficacy in patients with insomnia, receiving~     Lendormin D tablet under condition of normal clinical practice.~   "
102630|NCT02224001|"~     For achieving the desired refinements in Asian patients, sufficient septal cartilage must be~     needed for the ieal tip projection and lengthening of the nose by the septal extension graft,~     columellar septal strut graft, and onlay tip graft, shield graft. Actually there are many~     cases having insufficient septal cartilages in Asian augmentation rhinoplasty.~      The investigators propose the new technique, so called 'Flag Technique' by a tip-strut~     complex in a flag-like shape : using only the septal cartilage as an elongated columellar~     septal strut graft, a shield graft , bilateral mini-spreader grafts of the upper part in the~     elongated columellar septal strut graft without the septal extension graft to achieve the~     desired the result.~   "
102631|NCT02223988|"~     Ventilator-associated pneumonia (VAP) is a serious complication and carries increased risks~     of morbidity and mortality for patients who require mechanical ventilation.~      VAP is associated with the contamination and colonization of bacteria in the lower airway.~     These bacteria may be present in the lower airway by the aspiration of oropharyngeal~     secretions. Therefore limiting the amount of secretions that pass the glottis and enter the~     airway is paramount.~      Patients who require prolonged mechanical ventilation may have a tracheostomy tube placed to~     manage breathing. These tubes may have a distal cuff which sits within the trachea. When the~     cuff is inflated, oropharyngeal secretions will pool above the cuff of the tracheostomy tube~     thereby limiting the amount of secretions entering the lower airway. These secretions may~     leak around the cuff and cause tracheobronchial colonization. It has been shown that removal~     of secretions that pool above the cuff via dorsal lumen suction leads to a decreased~     incidence of VAP.~      The purpose of this study is to measure the effect of suction above the cuff tracheostomy~     tubes related to VAP incidence~   "
102641|NCT02223858|"~     Arthritis is a painful, disabling condition that disproportionately affects African~     Americans. Existing arthritis treatments yield only small to moderate improvements in pain~     and are not effective at reducing racial disparities in arthritis pain. According to the~     biopsychosocial model of pain, there is a need for novel interventions that target~     psychosocial factors associated with arthritis outcomes and disparities in outcomes. Evidence~     from the field of psychology suggests that an intervention designed to develop a positive~     mindset has the potential to improve pain and functioning and reduce racial disparities in~     patients with arthritis. Interventions to foster a positive mindset have been developed for~     clinical patient populations but have not yet been fully tested in patients with arthritis or~     in Veterans, nor have their effects on racial differences in clinical outcomes been examined.~     This study will address these gaps by testing the impact of an evidence-based positive~     activities intervention on pain and functioning in African American and White Veterans with~     knee arthritis.~   "
102632|NCT02223975|"~     Can vibrational spectroscopy be used to accurately assess vulval skin conditions? Vulval skin~     disorders are common and the diagnosis of these conditions can be difficult. Reliable~     discrimination between benign vulval skin conditions, precancerous conditions or vulval~     cancer often requires tissue biopsies. In addition the monitoring of patients with vulval~     disease at risk cancerous change is currently limited to visual assessment often supplemented~     by multiple invasive tissue biopsies. There are currently no established non invasive tests~     available for the diagnosis of vulval skin diseases.~      The vibrational spectroscopic techniques of Raman spectroscopy and Fourier transform infrared~     spectroscopy are non invasive diagnostic tools that use the interaction of light within~     tissues to identify the chemical composition of different tissues. The use of these tools may~     reduce the need for invasive biopsies to diagnose and monitor women with vulval skin disease.~      The aim of this project is to explore the use of vibrational spectroscopic techniques in the~     diagnosis of vulval skin disease. This will be achieved by performing vibrational~     spectroscopy on samples of tissue previously taken from women with vulval skin disease~     treated at Gloucestershire Hospitals NHS Foundation Trust. The results of the spectroscopy~     will be compared with the routine tests and the accuracy of spectroscopy determined.~   "
102633|NCT02223962|"~     Severe exacerbations are prevalent in a subgroup of patients with COPD and generally warrant~     a hospitalization. During the hospitalization, patients are extremely physically inactive~     with only a limited recovery one month after discharge. Physical inactivity is associated~     with negative health benefits. Therefore intervening in the period after and exacerbation~     seems useful to improve the levels of physical activity. Physical activity counseling and~     real-time feedback have already been applied in stable patients with COPD, with beneficial~     effects.The present study will investigate whether this specific intervention will help to~     improve the activity level in patients after an acute exacerbation. Further we investigated~     the effects of the intervention on improvements in functional exercise capacity.~   "
102634|NCT02223949|"~     The purpose of this study is to investigate whether mechanical cervical ripening (using the~     Cook double balloon catheter) is superior or inferior to pharmacological agents (PGE1) in~     overweight and obese women undergoing labor induction.~   "
102635|NCT02223936|"~     Prospective, multicenter study following for 2 years, 250 children who presented during the~     first trimester of pregnancy an isolated nuchal translucency over the 95th percentile of~     Nicolaïdes Curves on ultrasound and comparing them to a control group of 250 children whose~     pregnancy was normal. Evaluating morbidity, mortality, growth and the neurodevelopment of~     each group by a Brunet Lezine scale. Evaluating anxiety and depression in parents of those~     children using a scale.~   "
102636|NCT02223923|"~     This study will investigate the use of a new drug targeting the DNA repair pathway AZD6738,~     an ATR inhibitor). Many tumours have lost important DNA repair functions and rely more~     heavily on a few remaining repair pathways to survive. Preclinical studies indicate that, in~     these tumours, preventing the function of the remaining pathways will lead to tumour cell~     death, while sparing normal cells. This study aims to investigate the safety and tolerability~     of the new drug in patients with advanced cancer, as well as in combination with palliative~     radiotherapy, where the drug may increase the effectiveness of radiotherapy by preventing~     repair of the radiationinduced DNA damage. As the drug has only been given to a small number~     of patients, the study will focus on safety and finding the correct dose to proceed to~     further studies, although preliminary signs of drug activity will also be examined.~      The initial part of the study will administer increasing doses of the drug to groups of~     patients with advanced cancer who have no standard anticancer treatment options available.~     Testing will establish whether the drug levels in the body and tumour are adequate for the~     drug to have an effect, and any toxicity will be assessed. After the recommended dose is~     established, the recommended dose schedule will be stablished by trialing different~     schedules. Participants will be tested to see if their tumours lack the main DNA repair~     pathway (those who are predicted to have a better response to this drug). Finally, the drug~     will be given to patients with advanced cancer who require a course of radiotherapy for~     symptom control - the drug will be tested at different doses and with different doses of~     radiotherapy.~      Side effects will be monitored and tests will establish whether the drug is enhancing the~     radiotherapy effect in the tumours or normal tissues.~   "
102637|NCT02223910|"~     Background: The technology of brain-computer interfaces (BCI) enables the monitoring of brain~     activity and the generation of a real-time output about specific changes in activity~     patterns. The recorded subject receives a feedback about the neural activity associated~     his/her efforts and can thus learn to voluntarily modulate brain activity. There is~     accumulating evidence that training of motor cortex activations with brain-computer interface~     systems can enhance recovery in stroke patients. Here we propose a new approach which trains~     resting-state correlates of motor performance instead of activations related to movements.~     Previous studies have shown that the more resting-state alpha oscillations in the motor~     cortex are coherent with the rest of the brain, the better stroke patients perform in motor~     tasks. Furthermore, observational studies have suggested that training of alpha-band~     coherence in the motor cortex with neurofeedback has beneficial effects on motor performance.~      Objective : This randomized controlled study aims to test the usefulness of training~     functional connectivity between the motor cortex and the rest of the brain with a~     brain-computer interface in patients with chronic stroke. We hypothesized that this network~     variant of neurofeedback training will lead to region and frequency specific increases in~     functional connectivity and to an improved function of the affected upper extremity.~      Methods : 10 patients with chronic stroke and significant unilateral deficit of upper~     extremity motor function will perform two periods of neurofeedback training in a randomized~     cross-over design. In one period, they will train alpha-band coherence between intact areas~     around the affected motor cortex and the rest of the brain. In a control period, they will~     train alpha-band coherence between a control region not directly related to motor function~     (the medial prefrontal cortex of the healthy hemisphere) and the rest of the brain. In each~     period, two training sessions per week will be performed for 4 weeks. The periods are~     separated by at least 4 weeks. Oscillations in the brain will be reconstructed from 128 EEG~     channels using an adaptive spatial filter and the coherence between the target area and the~     rest of the brain will be calculated in real time. Coherence magnitude will be displayed in~     the form of a cursor on a computer screen.~      Significance: This study may provide causal evidence for a role of functional connectivity in~     motor learning and may lead to new strategies for rehabilitation.~   "
102638|NCT02223897|"~     Ischemic-type biliary lesions (ITBLs) are a major cause of graft loss and mortality after~     orthotopic liver transplantation (OLT). For now, there are still lacking effective treatment~     for ITBLs. The purpose of this study is to confirm whether human umbilical cord mesenchymal~     stem cells are effective in the treatment,or prevention of Ischemic-type Biliary Lesions~     after liver transplantation.~   "
102639|NCT02223884|"~     This is the phase II, single-arm, single-center study assessing the efficacy of weekly~     docetaxel plus carboplatin in second-line treatment of malignant melanoma (unresectable or~     metastatic) who has failed dacarbazine or temozolomide contained therapy. The primary end~     point is overall response rate according to RECIST 1.1 criteria assessed using CT or MRI and~     secondary end point includes disease control rate, progression free survival, overall~     survival and safety.~   "
102640|NCT02223871|"~     This was a single-center study using induced blood stage malaria infection to characterize~     the activity of ACT-451840 against early Plasmodium falciparum blood stage infection~   "
102642|NCT02223845|"~     To investigate whether listening to music at the time of embryo transfer reduces anxiety~     levels in women undergoing assisted conception treatment.~   "
102643|NCT02223832|"~     This is a study to evaluate the relative pharmacokinetic properties and the tolerability and~     safety of ACT-128800 in Japanese and Caucasian healthy male and female subjects after~     single-dose administration.~   "
102646|NCT02223793|"~     The overall goal of the present project is to contribute to new knowledge about the effect of~     a low threshold population screening system for cardiovascular risk factors in Norway.~     Further, this project aim to study if identifying high cardiovascular risk itself may lead to~     beneficial changes in health behaviors such as physical activity, diet, tobacco and alcohol~     behavior together with reduced risk score of cardiovascular disease, across socioeconomic~     status. This fall, a nationwide, free screening of cardiovascular risk factors will be~     conducted in 150 pharmacies in Norway. All participants that consent to participate will~     measure full lipid-profile, blood pressure, HbA1c, body weight and height by health care~     providers in pharmacies. Based on their measurement levels, participants will be stratified~     into either a low or a high risk group. In the high risk group, participants will further be~     randomized to either the intervention group or one of the two control groups. Participants in~     the intervention group will be informed about all their measurement levels with comparison to~     the recommended levels. Contrary, participants randomized to the two control groups will have~     delayed information of their measured levels. Participants in the intervention group and the~     first control groups will receive general oral and written information about how to lower~     their measurement levels in 8 weeks. In the second control group, participants will not~     receive any information at the first visit. In this way the investigators may be able to~     isolate the effect of identifying high risk and high levels of the risk factors itself. All~     groups will be given a diet- and physical activity questionnaire at visit 1, and will be~     invited back after 8 weeks to once more perform the measurement screening and receive the~     same questionnaire. At visit 2, all participants will, after the measurement screening, be~     informed about their measured risk factors and receive information on how to lower their~     levels. 1 year after inclusion, all participants in the three groups will be invited back for~     a one-year follow up visit in pharmacy.~   "
102647|NCT02223780|"~     Chronic obstructive pulmonary disease (COPD) is a common and, despite existing treatment~     options, progressive lung disease. Patients with COPD often have only limited access to~     palliative care. The goal of this research project is to improve the quality of life of~     patients with COPD.~      Background In many cases, the symptoms of advanced COPD (including shortness of breath, pain~     and depression) are insufficiently alleviated. In addition, often in connection with an~     infection, patients frequently suffer from respiratory decompensation; this may lead to~     invasive interventions as well as the admission to the emergency room or an intensive care~     unit. It may ultimately lead to the death of the patient.~      Aim This study aims to show that early palliative care can reduce the number of necessary~     invasive interventions and improve the quality of life of patients with COPD. For this~     purpose, a group of patients receiving early, standardized palliative care will be compared~     to a group of patients receiving customary treatment only, without systematic intervention by~     palliative care experts.~      Significance The results of this study should make it possible to efficiently use the medical~     resources which are required for the appropriate care of patients with COPD. The goal is the~     best possible quality of life and better coordination of the measures taken, especially with~     regard to the area of acute care and the wishes of the patient.~   "
102648|NCT02223767|"~     This study investigates the beneficial effects of prefrontal brain stimulation (with a~     facilitating TMS protocol) before exposure therapy in acrophobic patients. The two exposure~     sessions were realized in virtual reality. Before and after therapy, the phobic symptoms were~     measured on a subjective, behavioral and physiological level. The placebo-controlled single~     blinded study includes 50 phobic patients, which were randomized into verum or sham TMS.~   "
102649|NCT02223754|"~     The purpose of this study is to test the performance of an investigational multifocal test~     soft contact lens.~   "
102650|NCT02223741|"~     This study is designed to assess effectiveness, safety and cost-utility of conventional~     rehabilitation and traditional Korean medicine conjugated rehabilitation on children with~     cerebral palsy.~   "
102651|NCT02223728|"~     Interventions to help individuals with traumatic brain injury manage their healthy lifestyle~     behaviors have been limited. Thus, the goal of this project is to evaluate the efficacy of a~     telehealth lifestyle program on reductions in weight and improvements in health~     behaviors/lifestyle choices.~   "
102652|NCT02223715|"~     The aim of this study is to conduct an Asia-Pacific, multi-center, prospective observational~     study to characterize patients with CDI as well as to understand treatment and management of~     the disease.~   "
102653|NCT02223702|"~     The objective of this randomized clinical study was to evaluate the effect of systemic~     administration of moxifloxacin compared to amoxicillin plus metronidazole combined with~     non-surgical treatment in patients with generalized aggressive periodontitis (GAgP) in~     6-month follow-up.~      A total of 40 systemically healthy patients with GAgP will evaluate in this randomized~     clinical trial. Periodontal parameters (plaque index, gingival index, probing depth, bleeding~     on probing, clinical attachment level) will be recorded at baseline, 1st, 3rd and 6th month.~     Patients will receive either 400 mg moxifloxacin per os once daily or 500 mg metronidazole~     and 500 mg amoxicillin per os three times daily for 7 days consecutively.~   "
102654|NCT02223689|"~     Effectiveness of a surgical adhesive on wounds found in Emergency Medicine.~   "
102655|NCT02223676|"~     The purpose of this study is to investigate the effect of implementing clinical pharmacists~     in the Emergency Department Team at Randers Regional Hospital. The clinical pharmacists~     conduct medication history, make medical interaction screenings, -reconciliations and~     -reviews on unscheduled patients admitted to the Emergency Department during daytime.~   "
102656|NCT02223650|"~     The objective of this short-term, pilot randomized trial comparing 2.50 diopters (D)~     overminus lens treatment vs. non-overminus (spectacles without overminus or no spectacles) in~     children with intermittent exotropia (IXT) 3 to <7 years of age is to determine whether to~     proceed to a full-scale, longer-term randomized trial.~   "
102657|NCT02223637|"~     The Novartis Meningococcal quadrivalent CRM-197 conjugate vaccine pregnancy registry is~     stablished to meet a post marketing commitment agreed upon with CBER to prospectively collect~     data on pregnancy exposures to Novartis Meningococcal quadrivalent CRM-197 conjugate vaccine.~      It is an observational study of women inadvertently immunized with the Novartis Meningococcal~     quadrivalent CRM-197 conjugate vaccine within 28 days prior to conception or at any time~     during pregnancy as part of routine care.~      The objective of the pregnancy registry is to evaluate pregnancy outcomes among women~     immunized with the Meningococcal quadrivalent CRM-197 conjugate vaccine within 28 days prior~     to conception or at any time during pregnancy. The primary outcomes of interest include major~     congenital malformation, preterm birth, and low birth weight. Other pregnancy outcomes will~     be collected, including spontaneous abortions and stillbirths.~   "
102687|NCT02223247|"~     This first in human phase 1 study of TVB-2640 is being conducted in patients with advanced~     stage solid malignant tumors. This research is being done to find out how safe and useful~     TVB-2640 is for patients who have received previous cancer therapy, and for whom no therapy~     exists that would be curative or might provide significant benefit. TVB-2640 belongs to a~     class of drugs called fatty acid synthase inhibitors (FASN inhibitors). This means that they~     interfere with the body's (and the tumor's) ability to use a substance called fatty acid~     synthase (FASN). Research has shown that some tumors appear to need FASN to keep growing.~   "
102658|NCT02223624|"~     Many studies have shown that exercise training is beneficial for patients with chronic heart~     failure (CHF). Heart Foundation guidelines strongly recommend regular physical activity and~     referral to a specifically designed rehabilitation program for all patients with CHF who are~     medically stable. Such programs usually comprise aerobic exercises such as walking, and light~     weightlifting with care to avoid heavy straining due to stress that this may place on the~     heart.~      Eccentric contractions are those in which the muscle lengthens as it contracts. Exercise~     involving eccentric contractions is known to increase muscle strength and this type of~     exercise also requires less oxygen. This is because it requires less power to resist lowering~     a weight than it does to lift a weight. Initial evidence suggests that this form of exercise~     has favourable outcomes in the frail elderly and those with chronic disease.~      This study aims to determine if eccentric exercise can be applied to patients with heart~     failure to increase their physical function while using less energy so that exercise is more~     tolerable for patients who complain of significant breathlessness and fatigue. This study~     also aims to determine if eccentric exercise is a safe alternative exercise option for~     patients at risk of negative events.~      The investigators propose to run a randomised controlled trial. Eccentric exercise will be~     delivered to a group of heart failure patients referred to the existing heart failure~     rehabilitation program at the Northern Hospital. The program will consist of eight weeks of~     twice weekly exercise of one hour's duration comprising eccentric exercise combined with~     walking and light weight training. This will be compared to a group of patients participating~     in the current exercise program consisting of light weightlifting and aerobic exercises for~     the same length and duration of exercise and also to a third group of patients who will be~     wait listed for 8 weeks. Following the completion of the eight week waiting period, these~     patients will be offered the option of joining the standard exercise program.~      The investigators expect that the eccentric exercise group will have improved walking~     capacity and quality of life compared with the traditional program and the wait-list control~     group. It is also possible that there is no difference between the eccentric and traditional~     program in terms of functional outcomes but that the participants report that eccentric~     exercise is easier.~   "
102659|NCT02223611|"~     The purpose of this study is to evaluate S1 capsule plus Cisplatin as adjuvant treatment in~     stageⅡ and Ⅲa non-small cell lung cancer. It is the first study in the world to investigate~     the safety and efficacy of S1 capsule using in stageⅡ and Ⅲa non-small cell lung cancer~     patients after the complete resection.~   "
102660|NCT02223598|"~     The purpose of this study is to determine the safety, tolerability, dose limiting toxicities,~     and maximum tolerated dose of CB-5083 in subjects with lymphoid hematological malignancies.~   "
102661|NCT02223585|"~     Gut microbiota are involved in the regulation of mammalian metabolic pathways through~     host-microbiota metabolic, signaling, and immune-inflammatory interactions that~     physiologically connect the gut, liver, brain, and other organs. Correlation of these~     metabotypes with gut microbial profiles facilitates deciphering inherent host-microbe~     relationships.~      Microbiome sequencing have generated novel insights into the role of gut microbial~     composition in health and disease, but are limited in addressing the microbial contribution~     to host metabolism and the gut microbial dysbiosis in disease.~      This is an exploratory trial, aiming to examine how gut microbial conditions determine~     response to dietary challenge by measuring urine, plasma and stool metabolites resulting from~     metabolism of protein, polyamines and bile acids in combination with stool bacterial~     composition. The focus of this trial is to evaluate impact of protein based food challenges,~     based on cross-over design of two diet challenges of animal and vegan protein sources.~   "
102662|NCT02223572|"~     Due to its prevalence worldwide, osteoporosis is considered a serious public health concern.~     The worldwide annual incidence of Osteoporotic fractures is approximately 2 million in the US~     only.~      Hip fracture is associated with serious disability and excess mortality. Studies have shown~     that an initial osteoporotic fracture is a major risk factor for a new fracture. An increased~     risk of 14.8% for a secondary hip fracture has been demonstrated in people that have already~     sustained a fracture in the past 4 years (In average). These data indicate the major~     opportunity afforded by secondary fracture prevention strategies.~      By responding to the first fracture, we can reduce the incidence of second and subsequent~     fractures. However, even after longer medical follow-up according to regular standard of~     care, medical treatment and rehabilitation, the medical system has been unable to translate~     the eminent risk into an effective preventive treatment.~   "
102663|NCT02223559|"~     The assessment of pulmonary artery pressure (PAP) and parameters describing right ventricular~     function stand in the focus of the diagnosis and clinical management of pulmonary~     hypertension (PH). Right heart catheterization (RHC) is the gold standard method to measure~     PAP and to provide hemodynamic information on right ventricular function. However, due to its~     invasive nature, RHC is not optimal for screening and for close monitoring of the disease.~     Therefore, the development of non-invasive methods providing reliable PAP measurements and~     right ventricular functional parameters would be of major benefit.~      Today, the most often used comprehensive non-invasive method for these purposes is~     echocardiography. However, the method has limitations; in many cases PAP is significantly~     under- or overestimated - especially in subjects with co-existing pulmonary diseases.~     Regarding right ventricular function, although novel echocardiography parameters appear to be~     promising, they have not yet been evaluated in all forms of PH.~      Another emerging non-invasive method is cardiac magnetic resonance imaging (MRI). MRI is~     considered to be as gold standard for the non-invasive assessment of right ventricular~     function. In addition, our group showed that with a special approach (vortex method), MRI~     enables the determination of PAP with physiologic accuracy, but the method has not yet been~     validated systematically in different forms of PH.~      All patients undergoing right heart catheterization in our clinic are candidates for the~     study. Excluded will be patients not eligible for MRI or declining to take part in the study.~     MRI and Echocardiography will be performed within two weeks of the RHC.~      Hypothesis:~        1. MRI is superior to echocardiography to non-invasively determine mean PAP in a broad~          collective of patients with PH of diverse ethology.~        2. MRI derived right ventricular functional parameters correlate better to invasive~          measurements and to established prognostic parameters than echocardiography derived~          right ventricular functional parameters.~        3. Novel right ventricular tissue Doppler parameters add substantially to classical~          echocardiography parameters to describe right ventricular function.~   "
102664|NCT02223546|"~     Choroidal volume measured fluctuates significantly over a 24 hour time frame.~   "
102665|NCT02223533|"~     Objectives: For major laparoscopic surgery, as with open surgery a multimodal analgesia plan~     can help control postoperative pain. Placing a wound catheter intraoperatively following~     colon surgery could optimize the control of acute pain with less consumption of opioids and~     few adverse effects.~      Methods: We conducted a prospective, randomized, study of 103 patients scheduled to undergo~     laparoscopic colon surgery for cancer in Galdakao-Usansolo Hospital.~      Patients were recruited and randomly allocated to wound catheter placement plus standard~     postoperative analgesia or standard postoperative analgesia alone. A physician from the acute~     pain management unit monitored all patients for at multiple points over the first 48 hours~     after surgery. The primary outcome variables were verbal numeric pain scale (NRS) scores and~     amount of intravenous morphine used via patient controlled infusion.~   "
102666|NCT02223520|"~     This trial will test the hypothesis that treating parents of neonates requiring NICU care~     with intranasal mupirocin and topical chlorhexidine bathing will reduce the spread of S.~     aureus from parents to their neonates.~   "
102667|NCT02223507|"~     The objective of the present study was to obtain information about the safety, tolerability~     and pharmacokinetics of BIIR 561 CL after continuous intravenous administration of two~     increasing doses in healthy elderly volunteers, following the infusion schema of a loading~     dose (1 hour) and a maintenance dose (5 hours)~   "
109104|NCT02139345|"~     This is a prospective, randomized, multicenter clinical study to compare the safety and~     efficacy of TC-A PS total knee system with TC-PLUS Solution PS total knee system in Chinese~     subjects.~   "
102670|NCT02223468|"~     The microbiota represents the collections of microbial communities that colonize a host. In~     health, the microbiota protects against pathogens and maturation of the immune system. In~     return, the immune system determines the composition of the microbiota. Altered microbial~     composition (dysbiosis) has been correlated with a number of diseases in humans. The real~     role of the microbiota in transplant recipients is still unknown even though we suspect that~     it may be affected directly or indirectly by immunosuppressive drugs and antimicrobial~     prophylaxis taken by transplant patients, as well as by inflammatory process secondary to~     ischemia/reperfusion injury.~      A number of studies have investigated the impact of liver transplantation on the intestinal~     microbiota. In a recent analysis of stool flora (Microb Ecol 2013; 65: 781-791) in 12 liver~     transplant recipients, changes in the microbiota were correlated to post-transplant~     infections. The authors suggested that the shift to pathogenic strains of bacteria due to the~     use of prophylactic antibiotics may be contributing to post-transplant complications. In a~     larger study, Wu et al (Hepatobiliary Pancreat Dis Int 2012; 11: 40-50) demonstrated marked~     changes in the gut microbiota post-transplantation with an increase in Enterobacteriaceae and~     Enterococcus, and reduction in Eubacteria, Bifidobacterium and Lactobacillus species. These~     changes, however, resolved over time such that by 6 months, at times when bacterial~     prophylaxis ends and immunosuppression is reduced.~      A better characterization of the impact of post-transplant therapy on the human microbiota~     has the potential to improve our understanding of the infection process and translate into~     development of new therapeutic strategies.~      The main goal of this study is to characterize intestinal microbiota and confirm the same~     bacterial DNA in peripheral blood and portal lymph nodes in patients affected with end-stage~     chronic liver disease, and to analyze its evolution from the moment of inclusion in waiting~     list throughout the first year after liver transplantation. For each patient, a healthy~     CONTROL with a similar age (± 10 years) will be selected from the same family setting, in~     whom just one sample will be obtained during the enrollment phase.~      The second goal is to analyze the potential associations between microbiota flora and~     transplant outcomes during the same period.~   "
102671|NCT02223455|"~     Hand hygiene is the single most effective practice in preventing the spread of~     hospital-acquired infections. Despite the strength of the evidence, hospital staff continue~     to sanitize their hands less than half of the time required by guidelines. Effective~     interventions are needed to improve hand hygiene compliance rates among hospital staff, but~     most are of poor quality and do not examine the specific effects of individual interventions.~     This study will build a bundle of three hand hygiene interventions using a research design~     that allows for the effectiveness of each intervention to be measured individually and~     combined.~   "
102672|NCT02223442|"~     Chronic pain is defined as pain that persists after healing of the wound that caused it, and~     can occur even in the absence of any obvious pathological trigger. In our country, there is a~     growing interest in the proper management of the disease pain.~      Pain is also the first symptom of the disease in 20 -50% of patients with neoplastic disease~     and from 75% to 90% of patients with advanced cancer suffers from chronic pain .~      However, pain management is mostly inadequate. This study aims to assess the Italian clinical~     practice in reference to the pharmacological management of chronic pain by health~     professionals involved in the treatment of pain in some centers belonging to the Italian~     network of pain therapy.~   "
102673|NCT02223429|"~     The overall goal of this project is to identify the genetic, hormonal, and neurobiological~     influences on paternal nurturing behavior and to determine if fathers' neural responses to~     infants can be modulated by neuropeptides known to play a role in parenting in experimental~     animal models.~      The aim is to determine if pharmacological manipulation of central oxytocin (OT) and~     vasopressin (AVP) levels influences the neural response to viewing pictures of one's own~     infant or to hearing cry stimuli. In a double-blind procedure, fathers with 1-3 year old~     children will be scanned on two separate occasions; once under the influence of OT/AVP and~     once under the influence of placebo. Fathers will be randomized to either OT or AVP, and~     order of administration of drug and placebo will counterbalanced across subjects. Fathers~     will be scanned while viewing pictures of their own and an unknown child and while listening~     to unknown infant cry stimuli.~      The investigators hypothesize:~        -  OT will augment the ventral tegmental area (VTA), ventral striatum and medial~          orbitofrontal cortex (mOFC) response to viewing pictures of one's own child, and will~          augment the primary auditory cortex (AI) response of fathers to infant cries.~        -  AVP will augment the lateral septum response to viewing own child pictures.~   "
102674|NCT02223416|"~     Pharmacokinetic properties, safety and tolerability of RGB-10 and Forsteo will be compared in~     healthy female volunteers.~   "
102675|NCT02223403|"~     Nitrate-rich beetroot juice supplementation has demonstrated reduced oxygen consumption and~     submaximal exercise performance in healthy adults. Investigation for similar effects in~     patients with heart failure has not previously been conducted.~      This was a randomized, double-blind, placebo controlled trial. Following ingestion of the~     active agent or placebo, subjects with systolic heart failure underwent submaximal steady~     state exercise with gas exchange analysis followed thirty minutes later by a six minute walk~     test. Second testing sessions were performed ten days.~      There were no significant differences in the treatment and placebo arms in average oxygen~     consumption or six minute walk distance.~      In conclusion, in patients with heart failure who have ingested a single dose of nitrate-rich~     beetroot juice concentrate, there is no significant difference with regard to oxygen~     consumption during submaximal steady state exercise or six minute walk testing distance.~      Further study is warranted to determine the true efficacy of nitrate consumption in this~     population with adjustments in acute or chronic dosing, exercise duration, or intensity.~   "
102676|NCT02223390|"~     In this study, the investigators propose to develop Improving AIDS Care after Trauma~     (ImpACT), an intervention based on theories of stress and coping and evidence-based treatment~     for traumatic stress. The intervention will target women in South Africa who have histories~     of sexual trauma and are newly initiating antiretroviral therapy (ART) in order to reduce~     avoidant coping and traumatic stress, improve care engagement, and reduce HIV risk behaviors.~   "
102688|NCT02223234|"~     The overall objective of the proposed study is to test, among Canadian families, the~     comparative effectiveness of 2 different versions (doses) of a family-based obesity~     prevention intervention that is tailored to families' behavioural risk profile.~      To achieve this objective, we will conduct a randomized controlled trial of families with~     children aged 18 months- 5 years. Families will be randomized to 1 of 3 conditions: 1)~     Monthly emails with general health information (Attention Control), 2) Tailored weekly emails~     and 2 home visits with a health educator (Email +2), 3) Tailored weekly emails and 4 home~     visits (Email +4). The intervention will last 6 months, with follow-up at 12-months~     post-intervention (18 months from baseline). We will examine the impact of the intervention~     on the children's body composition, weight-related behaviours, and biomarkers of diabetes and~     cardiovascular disease risk.~      We hypothesize that, compared to children in the Attention Control, children in the Email +2~     and Email +4 conditions will achieve:~        1. a smaller increase in adiposity (primary outcome), age- and gender-specific body mass~          index (BMI),over a 6-month intervention period.~        2. higher frequency of family meals, child's sleep duration, physical activity, and fruit~          and vegetable intake and lower child's sugar-sweetened beverage intake, and sedentary~          behaviour over a 6-month intervention period. (secondary outcomes)~        3. lower diastolic blood pressure, glycosylated hemoglobin, fasting glucose, fasting~          insulin, Low Density Lipoprotein (LDL) cholesterol, triglycerides, C-reactive protein,~          trans and saturated fats, and higher High Density Lipoprotein (HDL) cholesterol over a~          6-month intervention period.~      We further hypothesize that there will be no significant difference in these outcomes between~     children in the conditions with 2 (Email +2) or 4 (Email +4) home visits.~   "
102677|NCT02223377|"~     Currently nearly 70% or more surgeries are being done as ambulatory (day care) procedures as~     they offer significant benefit to the patients as well as to the hospitals. Inadequate pain~     relief (30%-40%) and nausea-vomiting form the leading factors affecting the quality of care~     and hence its efficiency. Opioids form the primary modality to treat moderate to severe pain,~     but can also cause significant nausea-vomiting and other side effects. Although hydromorphone~     is five times more potent than morphine, in equianalgesic doses they both could provide~     similar pain relief. They both exert no ceiling effect for their analgesia, and hence~     incomplete or inadequate analgesia is related to the appearance of side effects. In this~     study the investigators shall assess the proportion of patients who satisfy the outcome of~     'satisfactory analgesia with minimal nausea-vomiting' in ambulatory surgeries, assessed at 2~     hours after surgery. Patients would be randomized to receive either morphine or hydromorphone~     in the surgical recovery area. All personnel involved with the study would be blinded. The~     investigators will also look to assess the time to discharge and other side effects. This~     will help to choose the better drug, thereby improving pain relief and side effects, and also~     the efficiency of health care delivery.~   "
102678|NCT02223364|"~     The purpose of this study is to find a better way to make patients comfortable after their~     knee surgery. The investigators compared three ways of providing pain relief, either by use~     of a nerve block at the femoral and sciatic nerve areas, or with actual injections in the~     surgical joint area with one of two different medicines, either ropivacaine or liposomal~     bupivacaine (Exparel®). The hypothesis was that the nerve block at the femoral and sciatic~     nerve areas would result in lower pain scores and opioid consumption than either of the two~     injections in the surgical joint area.~   "
102679|NCT02223351|"~     ASP2151 is an experimental treatment for herpes. HIV infected people are susceptible to~     contracting other infections because of their compromised immune system. As HIV patients will~     be taking drugs to treat the virus this study aims to see if ASP2151 would interact with one~     of the drugs that is commonly prescribed to HIV patients (ritonovir).~   "
102680|NCT02223338|"~     1. Background: Over 1 million intravitreal injections are performed annually in the United~          States. The most devastating complication related to these injections is~          endophthalmitis, with an incidence of 0.02 - 0.1% per injection. Techniques aimed at~          prevention of this complication have been studied, though emergence rates of antibiotic~          resistant bacteria in a single clinic population comparing antiseptic technique with~          iodine vs. use of post-injection second generation fluoroquinolones has not been~          reported in the literature.~        2. Objectives: The purpose of the study is to help determine the best way to prevent~          infection and limit antibiotic resistance in patients receiving eye injections.~        3. Procedures Involved (Research Interventions): After the patient is chosen based on~          inclusion criteria and agrees to participate in the study, exclusion criteria will be~          reviewed, cognizance will be determined, informed consent and HIPAA compliance forms~          will be signed. At this point and prior to the instillation of ophthalmic medications, a~          Rayon swab will be passed along the inferior fornix of the study eye while the patient~          looks up and the examiner lowers the lower eyelid. The swab will then be used to~          inoculate chocolate agar and a blood agar culture plates and a glass slide. These will~          be brought to the FMO microbiology department for culture and Gram stain. All~          Staphylococcus aureus and coagulase negative Staphylococcus species identified will be~          subjected to sensitivity testing using the Gram Positive antibiotic panel available at~          Loma Linda, with the addition of ciprofloxacin.~   "
102681|NCT02223325|"~     -  To compare the prognosis of acute pancreatitis between geriatric and other adult~          patients~        -  To evaluate the efficacy of various prognostic scores in geriatric patients with acute~          pancreatitis~   "
102682|NCT02223312|"~     The purpose of this study is to evaluate the safety and effectiveness of Tumor Associated~     Peptide Antigen (TAPA) pulsed dendritic cell (DC) vaccines in the treatment of progressive~     and/or refractory hematologic malignancies (HM). We hypothesize that treatment of patients~     with relapsed and/or refractory HM, without available potentially curative treatment options,~     and whose neoplastic cells express at least one (1) TAPA of a defined panel of TAPAs, using~     low-dose cyclophosphamide (CYP) followed by an autologous, monocyte-derived, TAPA-pulsed DC~     vaccine and low-dose granulocyte macrophage colony stimulating factor (GM-CSF), will result~     in TAPA-specific T-cell responses without significant toxicities. We also hypothesize CD4+~     T-cell and CD8+ T-cell responses generated against specific TAPAs may translate into clinical~     antitumor activity.~   "
102683|NCT02223299|"~     The purpose of this study is to determine if adding over the counter nutritional supplements~     will have a benefit to participants currently taking prescribed antidepressants who have not~     experienced complete remission of their depression symptoms.~   "
102684|NCT02223286|"~     The purpose of this study is to understand the use of Corus CAD also known as Age/Sex/Gene~     Expression score (ASGES) in the clinical decision making process of patients who underwent~     the evaluation of chest pain or anginal equivalent symptoms. Specifically, to better~     understand whether the use of the assay in clinical decision making resulted in changes in~     noninvasive diagnostic test ordering or diagnostic yield of additional tests ordered and/or~     invasive angiography.~   "
102685|NCT02223273|"~     Phase 1: An observational study ( registry) will be conducted with the objective of~     documenting the practice of stroke treatment in brazilian and latin american hospitals.~      Phase 2: A cluster randomized trial aiming to evaluate the effect of a multifaceted strategy~     to increase evidence based treatments usage for stroke patients. The hospitals will be~     randomized into two groups: the multifaceted strategy group and the usual care group.~   "
102686|NCT02223260|"~     The aim of the study is to investigate the safety and tolerability of dabigatran etexilate~     solution in children aged less than 1 year, to demonstrate comparable PK/PD relationship to~     older children and adults and to confirm dabigatran etexilate dosing algorithm for children~     aged less than 1 year.~   "
102701|NCT02223065|"~     The purpose of this study is to demonstrate bioequivalence of coadministered drugs on healthy~     subjects.~   "
102824|NCT02221466|"~     The purpose of this clinical study is to test whether or not patients treated with HBOT for~     diabetic foot ulcers will demonstrate measurable changes of the blood vessel function during~     the course of HBOT treatments. , i.e. an expected increase in the reactive hyperemic index~     (RHI) measured by the peripheral arterial tonometry (PAT).~   "
102689|NCT02223221|"~     Recurrent pregnancy loss (RPL) is a multifactorial disorder which affects about 1% of all~     couples and challenges both patients and clinicians technically and emotionally. IVF clinics~     see higher prevalence of RPL, since many RPL patients are seeking for assist reproduction~     treatment with or without other infertile factors. Guidelines for evaluation and treatment of~     RPL patients include screening for uterine abnormalities, parental chromosomes, autoimmune~     antibodies and cure gynecological infections, but there are still half of RPL patients remain~     unexplained.~      The documented high incidence of chromosomal errors in first-trimester miscarriages and an~     increased rate of aneuploidy in patients with RPL has led to the theory that screening~     embryos before implantation for aneuploidy may decrease the risk of a subsequent loss and~     serve as a possible treatment. The technology, indications of use, and even terminology for~     genetic testing of embryos have greatly changed since the first PGD(pre-implantation genetic~     diagnosis) baby was born in 1990. The current best evidence shows blastocyst biopsy followed~     by new rapid comprehensive chromosome screening(termed pre-implantation chromosomal screening~     or comprehensive chromosome screening, PCS or CCS, or the investigators generally termed PGS)~     based on array-comprehensive genome hybridization(aCGH), single nucleotide polymorphism~     array(SNP-array) or next generation sequencing(NGS), to be the most powerful technology.~     However, for whom this PGS technique is most suitable to achieve improved clinical outcome~     have not yet been identified by well defined, ITT based research with carefully selected~     control and adequate sample size.~      The investigators research is to determine whether in vitro fertilization (IVF)/~     intracytoplasmic sperm injection (ICSI) combined with SNP-array based pre-implantation~     comprehensive chromosome screening (CCS) will improve the clinical outcome of infertile~     female patients with recurrent spontaneous abortion history.~   "
102690|NCT02223208|"~     This is a multicenter study that includes two phases:~        1. A phase I study to define the maximum tolerated dose (MTD) of Romidepsin in addition to~          CHOEP-21 and to test the safety and feasibility of CHOEP-21 in combination with dose~          escalation of Romidepsin (8, 10, 12, 14 mg). The dose level defined as MTD of Romidepsin~          will be used for the subsequent phase II study.~        2. A phase II study to evaluate the efficacy (response rate, progression free survival and~          overall survival) and safety of Ro-CHOEP-21 incorporated into a treatment strategy~          including SCT.~   "
102691|NCT02223195|"~     Purpose and aims This as a pilot study that aims to investigate which inflammatory biomarkers~     can be found in saliva in children with Juvenile Idiopathic Arthritis (JIA).~      The hypothesis is that children with JIA will show a different pattern of inflammatory~     biomarkers in saliva than healthy Children.~      The null hypothesis is that there are no differences.~   "
102692|NCT02223182|"~     The objectives of this study are to evaluate the safety and efficacy of Viaskin Milk after 12~     months of epicutaneous immunotherapy (EPIT) treatment, for desensitizing IgE-mediated cow's~     milk allergic children and to assess the long-term safety and treatment efffect of up to 48~     months of treatment with Viaskin Milk~   "
102693|NCT02223169|"~     Heart disease and stroke are the most common cause of death in Ireland today.One of the main~     risk factors for heart disease and stroke is high blood pressure or hypertension. Research~     has found that certain specific proteins or peptides found in foods such as dairy, meat, fish~     and eggs may promote heart health reducing blood pressure in adults with hypertension. The~     aim of this study is to investigate the potential beneficial effects egg peptides may have on~     heart health, in particular, effects on blood pressure.~   "
102694|NCT02223156|"~     The main purpose of this study is to investigate effect of Medi Yoga on quality of life,~     biomedical factors and health care consumption, and to study gender differences between~     individuals diagnosed with paroxysmal atrial fibrillation (PAF). Furthermore, an additional~     purpose is to describe people's experiences of Medi Yoga and identify how Medi Yoga affects~     their condition.~      Hypothesis Individuals with PAF exercising Medi Yoga improve their quality of life and blood~     pressure, heart rate and heart rate variability. Biological markers such as NT-proBNP and CRP~     are positively affected, and that individuals seek less medical care.~   "
102695|NCT02223143|"~     Cardiovascular disease (CVD), including coronary heart disease (CHD) and stroke, is a leading~     cause of morbidity and mortality. Dyslipidemia has long been recognized to be the most~     important risk factor in the development of atherosclerosis in human beings. In Taiwan, the~     rates for hypercholesterolemia (≧250mg/dl) were 4.3% and 5.5% in 1970; 12.99% in 1980; and~     17.1% in 1990. Those for hypertriglyceridemia (≧200 mg/dl) were 6.5% and 11.1% in 1970 and~     13.0% in 1990. Low serum HDL-C was an isolated and independent coronary risk factor among a~     good number of Taiwanese people. Lowering of low-density lipoprotein cholesterol (LDL-C) with~     statins has in the last decade become part of the standard treatment regimen in patients with~     dyslipidemia. However, most embarrassing, is the insufficient data for clinical use in~     Taiwan. It is necessary to have rationalized and balanced guideline for the management of~     dyslipidemia in Taiwan, based on our local epidemiological, clinical and basic research data.~     Because all these trials were conducted in Caucasians and no large-scaled end-point research~     about the lipid lowering therapy (LLT) was published in Asians before, this registry study~     attempts to define the status of lipid lowering therapy in Taiwan and the effect of LLT on~     CVD morbidity and mortality in a large population of patients receiving primary or secondary~     prevention therapy. The medications will only depend on the decision made by the primary care~     physicians. The patient or physician can decide to be withdrawn from this registry at any~     time because of any reason. The lipid profile change, myopathy, or liver enzyme change after~     the LLT will also be recorded.~   "
102696|NCT02223130|"~     The purpose of this research study is to test a group program aimed at improving the quality~     of life of HIV+ Black men who have sex with men. The group will address ways to cope with~     discrimination and will help men examine mistrust that they may have about healthcare,~     including doctors and other healthcare providers and HIV medications. The aim is to provide a~     supportive community for HIV+ Black men.~   "
102697|NCT02223117|"~     This first-in-human exploratory IND, single-center study will assess the safety, toxicity,~     hematology, and immunogenicity of sub-therapeutic microdoses of autologous Thrombosomes® in~     healthy human subjects.~   "
102698|NCT02223104|"~     The purpose of this study is to demonstrate that the performance of Flexima Active is~     non-inferior to the performance of Sensura.~   "
102699|NCT02223091|"~     The aim of the study is to investigate the effect of a consultation training program for~     physicians on the quality of their consultations of breast cancer patients regarding~     complementary medicine. We assume that the training program might enhance the communication~     of relevant information, empathy of the physicians or satisfaction with the consultation.~   "
102700|NCT02223078|"~     Pancreatic, gastric, and colorectal cancers have all been shown to overexpress the gastrin~     gene and to be sensitive to the trophic effects of the gastrin in animal models. The~     hypothesis of this study is that G17DT will elicit specific and high-affinity antibodies that~     will bind gastrin-17, thus preventing the trophic activity of cancer cells.~   "
102702|NCT02223052|"~     This is a Phase 1, open-label, multicenter, randomized, 2-stage crossover study consisting of~     2 phases:~      Stage I - Pharmacokinetics (Bioequivalence), with an Extension Stage II - Pharmacokinetics~     (Food Effect) with an Extension~      This study will enroll approximately 60 subjects in stage I and 60 subjects in stage II with~     hematologic or solid tumor malignancies, excluding gastrointestinal tumors and tumors that~     have originated or metastasized to the liver for which no standard treatment exists or have~     progressed or recurred following prior therapy. Subjects must not be eligible for therapy of~     higher curative potential where an alternative treatment has been shown to prolong survival~     in an analogous population. Approximately 23 sites in the US and 2 in Canada will participate~     in this study.~   "
102703|NCT02223039|"~     This is a phase II, randomised, double-blind, placebo-controlled, multiple-dose, multi-center~     study of AbGn-168H in subjects with moderate to severe chronic plaque psoriasis. The~     objectives of this study is to investigate efficacy, safety, tolerability, and~     pharmacokinetics (PK) of multiple doses of AbGn-168H administered intravenously to patients~     with moderate to severe chronic plaque psoriasis.~   "
102704|NCT02223026|"~     Study to investigate the effect of food on the relative bioavailability of a 2.5 mg~     linagliptin+1000 mg metformin fixed dose combination (FDC) tablet~   "
102705|NCT02223013|"~     Comparative pharmacokinetics and tolerability of two experimental extended release~     formulations and a standard formulation of BIBV 308 SE following multiple doses.~   "
102706|NCT02223000|"~     Comparative pharmacokinetics of 2-4 experimental modified release formulations and oral~     solution of BIBV 308 SE following multiple doses, tolerability~   "
102707|NCT02222987|"~     Study to assess the influence of 75 mg clopidogrel on the pharmacodynamics and safety of 100~     mg terbogrel bid.~   "
102708|NCT02222974|"~     The objective of the study is to obtain information about safety, tolerability and~     pharmacokinetics of BIIR 561 CL after single intravenous administration of increasing doses~     in healthy male volunteers~   "
102709|NCT02222961|"~     The objective of the present study is to obtain information about the safety, tolerability~     and pharmacokinetics of BIIR 561 after continuous intravenous administration of increasing~     doses in healthy young volunteers~   "
102710|NCT02222948|"~     Primary Objectives:~        -  To assess the efficacy of vatelizumab compared to placebo as measured by a reduction in~          new contrast-enhancing lesions (CELs) in relapsing remitting multiple sclerosis (RRMS)~          patients.~        -  To evaluate multiple doses of vatelizumab for a dose-response.~      Secondary Objectives:~        -  To evaluate the safety and tolerability of vatelizumab compared to placebo.~        -  To evaluate the pharmacokinetics (PK) of vatelizumab.~   "
102711|NCT02222935|"~     Balance problems are addressed in low back pain patients. Dearth of literature available to~     prove core strengthening or any form of back exercises improving functional outcomes or~     balance in chronic back pain patients. No studies focus on balance training in improving~     balance of low back pain patients. The authors are conducting a randomised trial comparing~     balance exercises and routine back exercise program in improving pain, functional outcomes~     and balance of the patients~   "
102712|NCT02222922|"~     To assess the safety and tolerability at increasing dose levels of PF-06647020 in patients~     with advanced solid tumors in order to determine the maximum tolerated dose and select the~     recommended Phase 2 dose.~   "
102713|NCT02222909|"~     Project CONNECT (Community-based Organizations Neighborhood Network: Enhancing Capacity~     Together) is a randomized controlled trial that involves 22 community-based organizations~     (CBOs) located in Baltimore, MD. Half of these organizations were randomly assigned to the~     intervention group using a constrained cluster randomization process. The remaining 11 are a~     part of the control intervention group. The intervention is a co-developed set of IT tools~     hypothesized to improve the connections among intervention CBOs, Johns Hopkins health care~     facilities and CBO clients.~   "
102714|NCT02222896|"~     Demonstrate the reduction of bacteria on the skin~   "
102715|NCT02222883|"~     The aim of this prospective registration and translational research study is to evaluate the~     praevalence of BRCA regarding germline and somatic mutations.~   "
102716|NCT02222870|"~     The study will evaluate the safety and immunogenicity of the 2014-2015 formulation of Fluzone~     Quadrivalent vaccine, administered in a 1- or 2-dose schedule, in accordance with the~     Advisory Committee on Immunization Practices (ACIP) recommendations, in children 6 months to~     < 9 years of age.~      Objective:~        -  To describe the safety of the 2014-2015 formulation of Fluzone Quadrivalent vaccine,~          administered in a 1- or 2-dose schedule, in accordance with ACIP recommendations, in~          children 6 months to < 9 years of age.~      Observational objectives:~        -  To describe the immunogenicity of the 2014-2015 formulation of Fluzone Quadrivalent~          vaccine, administered in a 1- or 2-dose schedule in accordance with ACIP~          recommendations, in children 6 months to < 9 years of age.~        -  To submit available sera from each subject to Center for Biologics Evaluation and~          Research (CBER) for further analysis by the WHO, the Centers for Disease Control and~          Prevention (CDC), and the Food and Drug Administration (FDA) to support formulation~          recommendations for subsequent influenza vaccines.~   "
102717|NCT02222857|"~     Acute retinal necrosis (ARN) is a rare infectious retinitis which can potentially lead to~     devastating visual outcomes. ARN is diagnosed on the basis of the clinical appearance and~     disease course according to the diagnostic criteria proposed by the American Uveitis Society:~     (1) one or more foci of retinal necrosis with discrete borders in the peripheral retina; (2)~     rapid progression in the absence of antiviral therapy; (3) circumferential spread; (4)~     occlusive vasculopathy with arteriolar involvement; and (5) a prominent inflammatory reaction~     in the vitreous and anterior chambers.~      Herpesvirus infection, especially varicella-zoster virus (VZV) and herpes simplex virus~     (HSV), was presumed to be the pathogenic agent in the pathogenesis of ARN. Medical treatment~     with systemic antiviral agent had been the base of the therapy of ARN for decades and such~     treatment usually result in regression of retinitis.~      However, the visual outcome of ARN remains poor. The major causes of poor visual prognosis in~     ARN are retinal detachment and optic nerve or macular involvement by ischemic vasculopathy.~     Less frequent causes include macular hole formation, macular pucker, or hypotony.~     Rhegmatogenous retinal detachment may occur in 75 % of the untreated eyes. It may occur weeks~     to months after the onset of inflammation due to delayed formation of retinal breaks, which~     result from the combination of necrotic retina and vitreoretinal traction.~      Therefore, application of argon laser retinopexy prophylactically posterior to necrotic~     retina or prophylactic vitrectomy to reduce inflammatory factors and the vitreoretinal~     traction had been used to protect the healthy area from detachment. However, the results were~     varied and there is no consensus on the efficacy and indications of those prophylactic~     procedures. We had applied the prophylactic procedure in our treatment for ARN. We aim to~     access the efficacy of the treatment strategy of ARN and the correlated factors to the~     outcomes.~   "
109120|NCT02139137|"~     The study is designed to evaluate the effect of a novel computer training program on PTSD.~   "
102718|NCT02222844|"~     The IMPRESS trial aims to see whether the improved results can be achieved for patients with~     pelvic sigmoid cancers by having an MRI scan prior to surgery so that doctors can make the~     most appropriate treatment choice.~      Everyone who agrees to take part will be randomly allocated by one of the research team to~     either have standard treatment for sigmoid cancer, which involves CT-imaging of chest and~     abdomen / pelvis before surgery, or to undergo standard treatment, plus an additional MRI~     scan, before surgery. The additional MRI scan will be the only difference in approach between~     the two arms of the trial. After all imaging is obtained, patients from both arms will be~     discussed by the Multidisciplinary Team as usual. An amendment to this study in 2015 allowed~     for patients with sigmoid cancer who receive an MRI by local indication to be entered into~     the trial as observational patients, and a new primary endpoint added that compares the rates~     of high risk features identified between CT and MRI scans for all patients.~   "
102719|NCT02222831|"~     The aims of this study are to evaluate:~        1. the possible effect of time-lapse culture from day zero (day of oocyte retrieval) on~          fertilisation rates and embryo quality in standard IVF.~        2. the association between PIF status in embryo culture medium and embryo quality assessed~          by standard subjective parameters and morphokinetic development.~   "
102720|NCT02222818|"~     The purpose of this study is to demonstrate that the amount of effective CRT (Cardiac~     Resynchronization Therapy) pacing during AF (atrial fibrillation) when CAFRPlus (Conducted AF~     Response Plus) is applied is not inferior to the amount of effective CRT pacing during AF~     when CAFR (Conducted AF Response) is applied.~   "
102721|NCT02222805|"~     The investigators plan a study to randomize 540 children in Nepal to early (≤30 seconds) or~     late (≥180 seconds) clamping of the umbilical cord at birth. The children will be followed~     with blood tests (hemoglobin and ferritin) at 8 and 12 months of age, and their development~     is evaluated by questionnaire (Ages & Stages Questionnaire ) at 12 months of age, and by~     testing (Bayley -III) at 18-24 months of age. By implementing the project in a country with a~     high proportion of anemia at one year of age (about 75%), we can reduce the number of~     children in the study and still achieve significant results.~      Iron deficiency is a global health problem and causes anemia and impaired neurodevelopment in~     children. Anemia is estimated by WHO to occur among 25% of all children before school age,~     and the corresponding figure in Europe is 3-9 %.~      By waiting 3 minutes to clamp the cord after birth, a large part of the child's blood volume~     remaining in the placenta is transfused over to the child's body. Research shows that the~     neonate's blood volume can increase by about 40% and this blood contains 3 to 4 months'~     supply of iron. In Sweden, we have shown that late clamping of the umbilical cord could~     reduce iron deficiency in children at four months of age by 90%. Globally, most countries~     practice early cord clamping and the child is deprived of the placental blood transfusion.~     The hypothesis of the study is that by delaying the clamping of the umbilical cord, anemia at~     8 and 12 months will be reduced an this in turn will be beneficial for the childrens~     development.~      The project will be implemented at Paropakar Maternity and Women 's Hospital, Kathmandu. It~     hosts approximately 23,000 births annually.~   "
102722|NCT02222792|"~     A national, prospective, open-label, non-interventional, multicentre, controlled study~     designed to evaluate a diagnostic method in patients undergoing hip, knee or shoulder~     prosthetic removal regardless of whether or not infection is suspected. Serological test~     results will have no impact on the therapeutic approach.~      Study objective: To evaluate the diagnostic performance of an antibody detection kit for the~     serological diagnosis of bone and joint prosthetic device infections cause by Staphylococci,~     Streptococci, Propionibacterium acnes (P. acnes) and Gram-negative bacteria versus the~     reference method: the bacterial culture of deep intraoperative samples.~   "
102723|NCT02222779|"~     In this trial, concentrations of transition metals of interest are quantified in surplus~     cerebrospinal fluid (CSF) and blood serum samples. Quantification of the transition metals~     will be performed by inductively coupled plasma mass spectrometry (ICP-MS). The treating~     physicians as well as the patients will not be informed about the results of drug~     concentrations.~   "
102724|NCT02222766|"~     The obesity epidemic has spared no age group, including our youngest children. My and others'~     formative research shows that ethnically-diverse, low-income parents of young children are~     enthusiastic about learning general parenting skills, such as discipline strategies, but less~     interested in nutrition and physical activity. To capitalize on this enthusiasm, I will~     create and test an intervention that embeds strategies to improve child weight-related~     behaviors within a general skills parenting program.~      The overall goal of this study is to assess Parents and Tots Together (PTT), a family-based~     intervention to prevent obesity among children age 2 through 5 years. To achieve this goal,~     my colleagues and I will conduct a randomized controlled trial (RCT) among ethnically~     diverse, primarily low-income families. Our specific aims are to:~        1. Determine the extent to which the intervention, compared with a control condition,~          results in a smaller age-associated increase in body mass index (BMI) among children~          after a 3- month intervention and a 9-month follow-up period (primary outcome).~        2. Determine the extent to which the intervention, compared with a control condition,~          results in:~             1. Improved parent general parenting behaviors, i.e., increased use of positive~               discipline strategies.~             2. Improved parent feeding practices, i.e., increased responsiveness to child satiety~               cues.~             3. Improved child weight-related behaviors, i.e., increased sleep duration and~               physical activity, and reduced sugar-sweetened beverage intake and television/video~               viewing.~   "
102725|NCT02222753|"~     Colorectal cancer incidence is increasing at an alarming rate in China. Recent reports~     concluded aberrant immunological function was associated with colorectal cancer outcome,~     however, the influence of immunocyte subgroup and immunologic factors on cancer outcome in~     colorectal cancer survivors is largely unknown.The investigators will explore the impact of~     immunocyte subgroup and immunologic factors on colorectal cancer disease-specific,~     disease-free and overall survival. The investigators will recruit approximately 5,000~     patients as a prospective study cohort. During follow up, the investigators will explore the~     association of these factors with outcome of patients. The investigators believe that this~     project will improve the understanding of the impact of immunocyte subgroup and immunologic~     factors on colorectal cancer outcome.~   "
121836|NCT01972750|"~     In this study with a modified 3+3 dose finding design, a safe and tolerable dose of TKI258 in~     patients with relapsed glioblastoma should be established.~   "
102727|NCT02222727|"~     Introduction~      Aneurysmal subarachnoid hemorrhage (aSAH) is bleeding around the under surface of the brain~     caused by rupture of an aneurysm arising from a blood vessel. Stroke may occur in~     approximately one third of patients as a result of narrowing of the blood vessels around the~     brain, following aSAH.~      One theory as to why this may happen is because bleeding around the base of the brain damages~     particular cells (neurons) that control blood flow around the rest of the brain. These~     neurons may control blood flow by releasing a neurotransmitter called Acetyl Choline (ACh).~     Our hypothesis is that damage to these neurons may prevent the production of ACh, which then~     causes reduced blood flow and stroke if left untreated.~      By stimulating these neurons, we aim to investigate whether it is possible to improve the~     blood flow around brain and ultimately prevent strokes in patients following subarachnoid~     haemorrhage. Donepezil, a drug widely used in dementia, inhibits the brain's natural break~     down of ACh. We predict that by increasing the amount of Ach in these neurons, donepezil may~     improve blood flow to the brain, reducing the chance of developing stroke.~      Trial Protocol~      All patients admitted to St George's hospital with a confirmed aneurysmal subarachnoid~     haemorrhage between the ages of 18 and 85 years old will be invited to participate in the~     trial. The protocol has been designed to take place around the patients' aneurysm treatment,~     which is performed under general anesthesia (GA). Recruited participants will be anesthetized~     for their aneurysm treatment and then enter the study.~      All trial participants will have a Xenon CT scan under GA to assess brain blood flow prior to~     having treatment of their aneurysm. Patients randomized to donepezil treatment will receive a~     loading dose of 20mg via a feeding tube immediately after their Xenon scan. Patients in the~     control group will not receive the drug.~      All patients in the trial will undergo repeat Xenon perfusion scanning under GA between 3 and~     4 hours after their first scan, which coincides with the completion of their aneurysm~     treatment. Those in the donepezil group will then receive a daily dose of 5 mg for a period~     of 21 days.~      All aspects of care other than those related to the trial will be the same as for any other~     subarachnoid haemorrhage patients. Patients (or their legal representative for those unable~     to consent) will be able to decline participation in the trial or withdraw at any point.~   "
102728|NCT02222714|"~     The purpose of this study is to evaluate the safety, pharmacokinetics (PK) and preliminary~     efficacy of multiple ascending intravenous doses of 3K3A-APC, a Recombinant Variant of Human~     activated protein C (APC), in in the treatment of acute ischemic stroke following treatment~     with recombinant tissue plasminogen activator (tPA), mechanical thrombectomy or both.~   "
102729|NCT02222701|"~     The purpose of this study is to evaluate the clinical performance of resin composite~     restorations refurbished and compare with 2 groups of resins, 1 without treatment and another~     replaced resins acted as controls. The null hypothesis of this study is that the group of~     refurbished resins have a similar behavior to the control groups.~   "
102730|NCT02222688|"~     The purpose of the study is to investigate the safety of the investigational agent,~     cirmtuzumab. Cirmtuzumab is a monoclonal antibody drug designed to attach to a protein,~     called ROR1, on the surface of chronic lymphocytic leukemia (CLL) cells to block cell growth~     and survival. ROR1 is rarely expressed on healthy cells so the idea is to preferentially get~     rid of the cancer cells. Although there is evidence in laboratory animals that cirmtuzumab~     can decrease the number of CLL cells, the investigators do not know if this will work in~     humans. This drug will be given to humans for the first time in this study. Therefore, the~     goal of this study is to see if cirmtuzumab is safe and tolerated in study participants.~   "
102731|NCT02222675|"~     Aim of the study is to test whether surgical removal of a tumor under sonographic control as~     compared to conventional method reduces the rate of resections and local relapse~   "
102732|NCT02222662|"~     Through funding from the U.S. Maternal and Child Health Bureau, Teaching Research Institute~     at Western Oregon University (WOU) will be conducting research on the effect of a~     parent-delivered massage program on measures of autism and general development in children~     ages 6 to 11 with autism. Families will participate in an initial training, and receive 24~     sessions of ongoing support and training from a trained therapist over the first nine months.~   "
102733|NCT02222649|"~     A vitamin D3 high dose would act as an antioxidant and anti-inflammatory improving markers of~     oxidative stress and inflammation in the elderly. Seniors exhibiting polymorphism in the VDR~     gene would become non-responsive to supplementation.~   "
102734|NCT02222636|"~     The purpose of this study is to explore the optimal protocol for dexmedetomidine used in~     children during perioperative period.~   "
102735|NCT02222623|"~     The purpose of this study is to compare the safety and effectiveness of the two different~     basal insulins commonly used for basal blood sugar control in the treatment of type 2~     diabetes mellitus in patients who are hospitalized and require low doses of insulin: neutral~     protamine Hagedorn (NPH) insulin and glargine (Lantus®) insulin. Previous research has shown~     that both NPH insulin and glargine (Lantus®) insulin is safe and effective for the control of~     blood sugar in a type 2 diabetic patient. This research is being done because the costs of~     medications for diabetic patients are very expensive. Our goal with this research is to show~     that a less expensive insulin (NPH) is as safe and effective as a more expensive insulin~     [glargine (Lantus®)] in patients with type 2 diabetes mellitus who are in the hospital.~   "
102736|NCT02222610|"~     The purpose of this study is to assess the tolerability and efficacy of ranibizumab treatment~     administered in subjects with radiation retinopathy~   "
102737|NCT02222597|"~     The purpose of this study is to evaluate Near-Infrared Spectroscopy for intracranial hematoma~     detection of head trauma patients~   "
102738|NCT02222584|"~     Physical activity (PA) is beneficial in the prevention and management of chronic disease.~     However, few data exist regarding the level of PA in inflammatory bowel disease (IBD) and~     whether or not vigorous PA may have beneficial effects on patients' health. To evaluate the~     level of PA and the effect of PA on disease activity of patients with IBD. To evaluate the~     effect of PA on quality of life of patients with IBD.~   "
102739|NCT02222571|"~     This formative research shows that parents of preschool-aged children are enthusiastic about~     learning general parenting skills, such as discipline strategies, but that they are less~     interested in information on child nutrition and physical activity needs. To capitalize on~     this enthusiasm, Dr. Haines developed Parents and Tots Together (PTT), an intervention that~     embeds strategies to improve children's nutrition and activity behaviours within an existing~     general skills parenting program. Results from the investigators feasibility trial with 16~     Boston-area parents show that PTT is feasible for implementation and is extremely~     well-received by parents. Results are also encouraging with respect to changing parent~     feeding behaviours and children's nutrition and activity behaviours. What is not known is~     whether this program is feasible and contextually appropriate for Canadian families. Thus,~     the next step in this research program, and the overall goal of this study, is to assess~     Parents and Tots Together (PTT), a family-based intervention to prevent obesity among~     children 3 to 5 years of age, within the Canadian context.~      To achieve this goal, the investigators will conduct a pilot trial of the PTT program with 60~     families recruited through Ontario Early Years Centres (OEYC). The investigators will~     randomize 30 families to the 3-month PTT intervention and 30 to a control condition.~      The investigators primary objective is to implement and test the feasibility and~     acceptability of PTT among families with preschool children so appropriate revisions can be~     made to adapt it to a Canadian context. The investigators secondary objective is to compare~     the following outcomes among intervention versus control participants:~        1. Parent weight-related behaviours (i.e., parent physical activity, intake of~          sugar-sweetened beverages, and television/video viewing, as well as responsiveness to~          child satiety cues).~        2. General parenting behaviours (i.e., use of positive discipline strategies).~        3. Child weight-related behaviours (i.e., sleep duration, physical activity, intake of~          sugar-sweetened beverages, television/video viewing).~        4. Nutritional risk score based on a screening tool for preschoolers.~        5. Child change in body mass index (BMI), standardized to age and gender.~   "
102740|NCT02222558|"~     Low testosterone is a condition that occurs when the body is unable to produce sufficient~     quantities of testosterone. The medical name for low testosterone is hypogonadism.~     Hypogonadism can be caused by many factors. Symptoms include: decrease in libido, lack of~     energy and mood swings. The goal of testosterone replacement therapy is to return~     testosterone levels to the normal range and relieve symptoms.~   "
102741|NCT02222545|"~     The purpose of this study is to assess the safety, tolerability, and clinical activity of~     OMS721 in subjects with thrombotic microangiopathies (TMA), which include atypical hemolytic~     uremic syndrome (aHUS), thrombotic thrombocytopenia (TTP), and hematopoietic stem cell~     transplant -associated TMA (HSCT-associated TMA). The study will also evaluate clinical~     activity, pharmacokinetics (PK), pharmacodynamics (PD), and anti-drug antibody response~     (ADA).~   "
102742|NCT02222532|"~     Infants and children undergoing cardiac surgery require mechanical support for circulation~     called cardiopulmonary bypass. The artificial pump ensures that blood flow to the body is~     maintained during surgical procedure on the heart. However, the pump circulation disrupts~     regulation of thyroid hormone. This hormone is a critical regulator of heart and circulatory~     function. Deficiencies in thyroid hormone adversely affect recovery of the heart after~     cardiac surgery. A recent study by the principal investigator showed that supplementing~     patients younger than 5 months old shortened the time spent on the ventilator (breathing~     machine) after surgery. Populations undergoing heart surgery in developing countries such as~     Indonesia are different than those in the U.S. and other industrial nations. For many heart~     defects children undergo surgery at an older age. They are then sicker for longer periods,~     and are often malnourished. These older malnourished children have lower thyroid hormone~     levels even prior to surgery, and show dramatic further drops after surgery. Shortening time~     on the ventilator should improve their recovery, and also improve overall availability of~     resources in developing countries. The formulation of thyroid hormone provided in the U.S and~     given intravenous is relatively expensive. However, a much more inexpensive formulation is~     available in Indonesia, which can be given through a tube extending from the nose to the~     stomach. We propose testing this formulation made in Korea, known as Tetronine, in two~     vulnerable populations in Indonesia: children younger than 5 months of age, and those older~     than 5 months who are malnourished. All these patients will be undergoing cardiopulmonary~     bypass for congenital heart defects. This project will be an important collaboration between~     U.S and Indonesian investigators. If successful, it will have a general positive impact on~     care of the entire population of young children undergoing cardiac surgery in developing~     countries by reducing time on the ventilator and improving access to care.~   "
102743|NCT02222519|"~     provide evidence for prevention or reduction muscle pain.~   "
102744|NCT02222506|"~     The primary objective of these case series is to evaluate the safety and tolerability of the~     KLOX BioPhotonic System as adjunctive therapy to Standard Of Care (SOC) in patients with~     diabetic foot ulcers.~   "
102745|NCT02222493|"~     The study will assess the efficacy and safety of PF-06438179 and infliximab in combination~     with methotrexate in subjects with active rheumatoid arthritis who have had an inadequate~     response to methotrexate.~   "
102746|NCT02222480|"~     A 2-Week, Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the~     Efficacy, Tolerability, and Pharmacokinetic-Pharmacodynamic Relationship of Fimasartan in~     Combination with Hydrochlorothiazide in Patients with Mild to Moderate Hypertension~   "
102747|NCT02222467|"~     The primary objective of these case series is to evaluate the safety and tolerability of the~     KLOX BioPhotonic System as adjunctive therapy to Standard Of Care (SOC) in patients with~     venous leg ulcers.~   "
102748|NCT02222454|"~     The primary objective of these case series is to evaluate the safety and tolerability of the~     KLOX BioPhotonic System as adjunctive therapy to Standard Of Care (SOC) in patients with~     stage II or III pressure ulcers.~   "
102749|NCT02222441|"~     This study is designed to evaluate the potential effect of the moderate CYP3A inducer~     modafinil and the weak CYP3A inducer pioglitazone on the pharmacokinetics of palbociclib.~   "
102750|NCT02222428|"~     The primary objective of this study was to compare the systemic exposure of BI 1744 BS and CD~     1857 XX (the active metabolite of the pro-drug BI 54903 XX) at steady state following~     inhalation of the fixed dose combination (FDC) of 6.2 μg BI 1744 CL plus 727.3 μg BI 54903 XX~     (as ethanolic solution for inhalation, EIS) with the systemic exposure following inhalation~     of the mono compounds of 10 μg BI 1744 CL (as aqueous solution for inhalation, AIS) and 727.3~     μg BI 54903 XX (EIS), respectively, when administered once-daily via Respimat® Inhaler~     (Respimat® A for AIS and Respimat® B for EIS) for 14 days in healthy volunteers. Secondary~     objectives were to compare exposure to BI 1744 BS and CD 1857 XX after a single dose of the~     BI 1744 CL/BI 54903 XX (6.2 μg/727.3 μg) FDC and the mono compounds, respectively; to compare~     exposure to BI 54903 XX after a single dose and at steady state after multiple doses of the~     BI 1744 CL/BI 54903 XX (6.2 μg/727.3 μg) FDC and the mono compounds, respectively; to compare~     the safety and tolerability of BI 1744 CL and BI 54903 XX when administered as BI 1744 CL/BI~     54903 XX (6.2 μg/727.3 μg) FDC and as the mono compounds, respectively.~   "
102751|NCT02222415|"~     Resistance type exercise training has been shown to be a potent stimulus to increase skeletal~     muscle mass and strength in healthy men. Furthermore, timed protein intake is also known to~     affect the muscle adaptive response following exercise. Whether timed protein intake could~     augment the increase in muscle fiber size and/or satellite cell content following long-term~     exercise intervention remains to be established.~      We hypothesize that protein supplementation before sleep, on both training and non-training~     days, during a 12 week resistance training program further increases type II muscle fibre~     cross sectional area when compared to the placebo group.~   "
102762|NCT02222272|"~     Stem cell transplantation will continue to be a treatment option for patients with chronic~     myeloid leukaemia, despite the introduction of tyrosine kinase inhibitors. However, many~     patients will have received prior therapy with TKIs, including Nilotinib or Dasatinib at the~     time of allogeneic stem cell transplantation.~      While the use of Imatinib prior to stem cell transplantation seems to have no adverse impact~     on the outcome of allogeneic stem cell transplantation little is known on the impact of prior~     use of second generation TK inhibitors.~      Therefore this non interventional prospective study addresses this question and patients~     undergoing allogeneic stem cell transplantation after prior use of 2nd generation TKIs will~     be followed by the data office office on engraftment, treatment related mortality, relapse~     rate and survival, prospectively. Details on TKI therapy will be collected by the~     participating centers, retrospectively.~      This is a non interventional prospective study. There is no upper limit to the number of~     patients entered, but it is estimated that up to 450 patients will be included in 150 centres~     for this non interventional prospective study. The registry will include patients for three~     years plus one more year for follow up and data analysis which should then be followed-up~     until the projected end of the non interventional prospective study.~   "
109121|NCT02139124|"~     The purpose of this randomized, placebo-controlled, double-blind, parallel group study is to~     evaluate the clinical efficacy and safety of PRC-063 in adults with ADHD~   "
102752|NCT02222402|"~     The PEDAL study aims to evaluate the effectiveness of a 9-month intradialytic exercise~     training intervention designed to improve quality of life (QOL) and alleviate functional~     limitations in patients with stage 5 Chronic Kidney Disease (CKD) who are on haemodialysis.~     Exercise rehabilitation will be compared against established treatment options available~     within UK NHS haemodialysis (HD) units. A qualitative substudy will also investigate the~     experience and acceptability of the intervention for both participants and members of the~     renal care team. In addition, we want to examine whether this type of additional exercise~     treatment is cost effective within the health service setting.~      PEDAL is designed as a multi centre randomised clinical trial (RCT) and will recruit 380~     adult patients who have been on HD for at least 3 months, from 10 HD sites located in~     Scotland, England and Wales. The type of exercise programming will consist of cycling~     exercise performed during each dialysis session plus a muscle conditioning programme~     performed twice per week. All exercise sessions will be supervised by a physiotherapy~     assistant. The exercise prescription will be individualised for all patients on the basis of~     their fitness and clinical status.~      The main objective is to examine the impact of exercise rehabilitation on quality of life and~     well being of patients. We hypothesise that the exercise training delivered during~     haemodialysis treatment will significantly improve the functional limitations/abilities of~     the patients leading to the detection of clinically beneficial improvement in quality of life~     outcome, as measured by the KDQOL-36 physical composite score (PCS) at the primary end point.~   "
102753|NCT02222389|"~     Contingency management (CM) is a type of treatment used in the substance abuse field.~     Patients' behaviors are rewarded for adherence to a treatment plan. As an approach to~     treatment, contingency management emerged from the behavior therapy traditions in mental~     health. By most evaluations, contingency management procedures produce one of the largest~     effect sizes out of all mental health and educational interventions.~      The purpose of this study is to perform a randomized, controlled trial to evaluate the~     ability of a culturally-tailored contingency management (CM) intervention to increase alcohol~     and drug abstinence among American Indian (AI) tribal members from two rural reservations in~     the Northwest.~   "
102754|NCT02222376|"~     Pirfenidone is a synthetic molecule, which acts as a potent modulator of the effect of~     various cytokines (TNF-α, transforming growth factor-β, platelet derived growth factor and~     vascular endothelial growth factor, among others) that possesses anti-inflammatory and~     anti-fibrinolytic properties.~      The aim of this study is to compare the effect of topic treatment with pirfenidone compared~     to conventional treatment in chronic diabetic foot ulcers.~      The hypothesis is that treatment with topic pirfenidone in chronic diabetic foot ulcers~     (Wagner 1 to 2) reduces the ulcer size and shortens the healing time compared to conventional~     treatment. This is a randomized, controlled and crossover study. Patients will be randomly~     assigned to conventional treatment or topic pirfenidone for eight weeks. At the end of this~     period they will change groups. Each week ulcers will be for size, depth, length and evidence~     of infection. The ulcers will have proper debridement in the conventional treatment group and~     debridement plus topical pirfenidone application in the pirfenidone group. Subjects will be~     instructed to do daily ulcer cleansing and for those in the topical pirfenidone group, in~     addition to cleansing they will be instructed to apply the gel twice a day.~   "
102755|NCT02222363|"~     The purpose of this study is to evaluate the safety and tolerability of the investigational~     drug VLX600 in patients with refractory advanced solid tumors.~   "
102756|NCT02222350|"~     The objective of this study is to evaluate the efficacy and safety of DS-8500a compared with~     placebo in Japanese patients with Type 2 Diabetes Mellitus.~   "
102757|NCT02222337|"~     Latina breast cancer survivors report lower quality of life (QOL) than non-Latina survivors.~     Lower QOL can lead to poorer functional and cancer-related survival outcomes. The friends and~     family of Latina cancer patients are also impacted by a loved one's diagnosis of breast~     cancer. Through strong community-academic partnerships, the investigators seek to improve the~     QOL of Latina survivors and their caregivers with a culturally-relevant intervention. In this~     project, the investigators plan to further develop and refine the intervention and then test~     it through a randomized controlled trial. First, the investigators will conduct in-depth~     qualitative interviews with 10 survivor-caregiver dyads (pairs) to see if the intervention~     fits for survivors and caregivers in different parts of the country. Then, the investigators~     will revise the intervention. Finally, the investigators will test the intervention in a~     randomized controlled trial. The investigators will invite 125 survivor-caregiver dyads to be~     a part of our study. Half will be asked to complete the intervention and half will be offered~     the usual services, such as support groups. The information learned from this study could~     help improve the quality of life in Latina breast cancer survivors and their caregivers.~     Physicians, survivors, and community groups can also benefit from this study because they~     will have more information about the needs of Latina breast cancer survivors. The~     investigators hope to use the information to help other types of survivors and caregivers in~     the future.~   "
102758|NCT02222324|"~     This thorough QT (TQT) study will take place in healthy subjects administered single doses of~     study drug. It will be a randomized, double-blind, placebo and active-controlled, 4-treatment~     crossover study. Subjects will be randomized in an equal ratio to one of 12 possible~     treatment sequences. Each treatment sequence will comprise all 4 treatments.~   "
102759|NCT02222311|"~     The investigators wish to study the effect of Vitamin D on the development of autism in~     children. The investigators will also investigate the environmental and genetic influences on~     the level of Vitamin D in children with autism.~   "
102760|NCT02222298|"~     Video assisted ablation of pilonidal sinus (VAAPS) is a new endoscopic minimally invasive~     treatment. In an attempt to validate the effectiveness of the VAAPS, the investigators have~     designed a comparative study between the conventional and the minimally invasive treatment.~     Two surgical procedures were evaluated: VAAPS (Experimental group) and conventional excision~     with a Bascom out-midline closure (Control group).~   "
102761|NCT02222285|"~     The primary study objective is to evaluate the efficacy of Vayarin_005 on ASD related~     symptoms in children.~   "
102910|NCT02220348|"~     The purpose of this study is to determine the amount of linaclotide and its active metabolite~     (MM-419447) excreted in breast milk after multiple, once daily doses of linaclotide (145 μg~     or 290 μg) in lactating women receiving the drug therapeutically.~   "
102763|NCT02222259|"~     The purpose of this study is to determine the feasibility of implementing a randomized~     controlled study of the intervention (Geriatric Assessment followed by an integrated care~     plan carried out by the multidisciplinary geriatric oncology team) designed to~     maintain/improve quality of life and functional status in older adults with advanced~     gastrointestinal, genitourinary or breast cancer referred for first line chemotherapy.~      Secondarily, the study will investigate the impact of the Geriatric Assessment on the cancer~     treatment decision of the cancer specialist.~   "
102764|NCT02222246|"~     The goal of this pilot study is to improve emergency department (ED) pain management for~     adults with sickle cell disease. Sickle cell disease (SCD) is the most common genetic~     disorder in the United States, and occurs primarily among African Americans. Management of~     painful episodes associated with SCD, referred to as vaso-occlusive crises (VOC), is the most~     common reason for SCD patients to visit the ED. Currently, there is no standard approach to~     managing VOC pain in the ED that is widely accepted and used, and pain management for~     vaso-occlusive crisis in persons with SCD is very different between providers and not based~     on research. Many times, patients who come to the ED with sickle cell pain feel that they do~     not receive adequate pain control. If EDs could provide efficient, effective, safe,~     patient-centered analgesic management, it may be possible to improve pain management for~     adults with SCD experiencing a VOC. Guidelines for treating vaso-occlusive crises caused by~     sickle cell disease will soon be published by the National Heart, Lung and Blood Institute of~     the National Institutes of Health. These guidelines recommend patient-specific pain treatment~     protocols or a standardized pain management protocol for SCD when a patient does not already~     have a pain treatment protocol designed for them. The purpose of this pilot study is to~     compare these two ways to treat vaso-occlusive pain in the ED for adults with sickle cell~     disease, and to determine if a large randomized controlled trial is feasible and required.~   "
102765|NCT02222233|"~     To determine the relative bioavailability of single doses of 200 mg BI 671800 HEA (choline)~     administered as a delayed release (enteric coated) tablet; or via the EnterionTM capsule as~     solution to the jejunum, ascending or descending colon, or as particulate to the ascending~     colon~   "
102766|NCT02222220|"~     Hypersalivation (sialorrhea or ptyalism) is known as a frequent, disturbing, uncomfortable~     adverse effect of clozapine therapy that can lead to noncompliance. Until now there is no~     effective enough treatment for this side effect.~      Previous studies demonstrated that different medications from the substitute benzamide~     derivatives group: amisulpride, sulpiride (higher selective binding to the D2/D3 dopamine~     receptor) and moclobemide (reversible inhibitor of monoamine oxidase A, which inhibits the~     deamination of serotonin, norepinephrine and dopamine) may be effective as a treatment of~     clozapine-induced hypersalivation (CIH). Moreover, there is another substitute benzamide~     derivative: metoclopramide (dopamine D2 antagonist, usually used as antiemetic medication in~     general medicine). The investigators hypothesis assumes that anti-salivation effect~     characterizes the whole group of benzamide.~      The aim of this study was to examine the efficacy of metoclopramide as an optional~     possibility for management of CIH.~   "
102767|NCT02222207|"~     Part A (Phase IIa):~      Primary objectives:~      The study part A is designed to investigate whether the use of regorafenib eye drops can help~     patients with neovascular (wet) Age-Related Macular Degeneration (wAMD) to see better after 4~     weeks and 12 weeks after inclusion into this study.~      Secondary objectives:~      The study will also evaluate the safety and tolerability of the regorafenib eye drops.~      Part B (Phase IIb):~      Primary objectives:~      The study part B is designed to investigate:~        -  how often the regorafenib eye drops need to be given per day~        -  whether the use of regorafenib eye drops can help patients with neovascular (wet)~          Age-Related Macular Degeneration (wAMD) to see better after 4 weeks and 12 weeks after~          inclusion into this study.~      Secondary objectives:~      The study will also evaluate how the different dosings of regorafenib eye drops affect~     patients vision, the safety and the tolerability.~   "
102768|NCT02222194|"~     In case of PET or CT based cN1 (suspected) NSCLC, ESTS guidelines propose mediastinal staging~     by echo-endoscopy OR mediastinoscopy. Recent data show a sensitivity of less than 50% for~     echo-endoscopy to detect N2 disease in cN1 NSCLC patients, while prevalence of mediastinal~     nodal disease was 24% (unpublished data Aster II).2 The investigators plan to perform a~     prospective multicentric observational study to measure the sensitivity of mediastinal~     staging by video-assisted mediastinoscopy (VAM) in cN1 operable and resectable (suspected)~     NSCLC patients.~   "
102769|NCT02222181|"~     In Brazil, patients with Alzheimer's disease (AD) receiving free drugs of government. Even~     having access to, little is known about the effectiveness, safety and adherence of drug~     therapy in this group of patients. The research aims to promote adherence and develop~     strategies to address Drug-Related Problems (DRP's) in AD patients elderly of reference~     centre for the Elderly of Araraquara. The clinical parameters will be assessed at the~     beginning and after the educational intervention period from April 2014 to April 2015.~   "
102770|NCT02222168|"~     To evaluate the effect of food on the pharmacokinetics of BI 409306 and to investigate the~     pharmacokinetics of BI 409306 when given at bed time.~   "
102771|NCT02222155|"~     The aim of this trial is to test the safety and efficacy of two dose regimens of the~     complement C5a receptor CCX168 in patients with anti-neutrophil cytoplasmic antibody~     (ANCA)-associated vasculitis (AAV).~      Funding Source - FDA OOPD~   "
102772|NCT02222142|"~     Off pump coronary artery bypass graft (OPCAB) still requires myocardial protection owing to~     intermittent regional ischemic episode. The investigators retrospectively evaluated the~     cardioprotective and clinical outcomes of propofol versus isoflurane anesthesia in patients~     undergoing OPCAB.~   "
102773|NCT02222129|"~     A prospective, randomized comparison of bupivacaine to liposomal bupivacaine given by local~     injection at all the wound sites in patients undergoing robotic-assisted or laparoscopic~     urologic surgeries in an effort to determine which method reduced postoperative opioid use~     the most.~   "
102774|NCT02222116|"~     The objective is to demonstrate that the Flow Area within a blocked coronary vessel as~     assessed by OCT is greater with the MGuard Prime stent compared to non-mesh control stent~     (BMS/DES) in subjects undergoing primary PCI for ST-segment elevation MI. The study~     hypothesis is that end of procedure flow area is greater with the MGuard Prime compared with~     stenting with a non-mesh DES or BMS.~   "
102775|NCT02222103|"~     The investigators are proposing to use a wearable device, MultiSenseTM, developed by Rhythm~     Diagnostic Systems, Inc. which has many sensors inside in a Band-Aid like strip in order to~     see if it can help diagnose capabilities in individuals suspected of having obstructive sleep~     apnea. The MultiSenseTM sensor is a self-contained, reusable, rechargeable, battery-powered,~     flexible strip, measuring 4 X 1.2 inches that simultaneously tracks and records a number of~     physiological health related parameters such as ECG, heart rate, pulse synchronized oxygen~     saturation, temperature, respiratory rate, depth of respiration and motion/position. One~     advantage of this device over current home diagnostic systems is the capability for recording~     over several nights.~      The objective is to compare multiple biometric parameters tracked by the MultiSenseTM to gold~     standard monitoring in an accredited sleep lab using polysomnography. Home monitoring will~     explore potential findings supportive of sleep apnea while monitoring at home during routine~     sleep over 5 to 7 nights. Enrolling 10 adults already scheduled for a medically indicated~     sleep study will help us to make these determinations. Subjects will wear the device, which~     is the size of a Band-Aid, via adhesive to their chest over a period of 10 days. Subjects~     will go about their normal daily activities and return the device via mail once completed.~   "
102776|NCT02222090|"~     The aim of the present registry is to characterize and follow patients prospectively and~     retrospectively with renal impairment who have been prescribed apixaban for the prevention of~     stroke in atrial fibrillation, with a comparison to the characteristics and outcomes~     associated with warfarin therapy in this population.~   "
102777|NCT02222077|"~     This study aims to investigate in adolescents and young adults:~        -  the 24h diurnal variation of ambulatory central blood pressure~        -  the association of central compared to peripheral blood pressure with indices of~          asymptomatic target-organ damage~   "
102778|NCT02222064|"~     Research questions/hypotheses~        1. Can an individual mindfulness intervention for Gastro Intestinal Failure inpatients~          reduce pain-related distress, improve quality of life, and increase confidence in pain~          self-management?~        2. How useful and applicable do Gastro Intestinal Failure inpatients find Mindfulness~          methods?~   "
102779|NCT02222051|"~     In this study the efficacy of Tai Chi will be tested in comparison to conventional neck~     exercises and usual care in a randomized controlled trial. Tai Chi and neck exercises will be~     lead by a trained exercise therapist and Tai Chi instructor, both groups receive 12 weeks of~     training, once weekly for 60-90 min in a group setting. Pain, Disability, quality of life,~     wellbeing, stress perception, psychological distress will be used to determine effects.~   "
102780|NCT02222038|"~     The purpose of this study is to investigate the genetic architecture of Linear Localized~     Scleroderma (LLS) (linear morphea) by whole exome sequencing.~   "
102781|NCT02222025|"~     Playing football can induce considerable beneficial health effects, but is also a~     high-intensity and high-impact sport with many situations of direct contact between players~     which bear the risk of injury. Thus, it is necessary to implement preventive measures to~     reduce the risk of injury and support the health benefits.~      Injury characteristics of players older than 13 years are similar to adult players and, thus,~     similar preventive measures are beneficial. Younger players seem to show partly different~     injury characteristics. Consequently, preventive programmes proven effective in late~     adolescent or adult players need to be adapted for younger age groups. To date, no study~     investigated the prevention of football injuries in children under the age of 13 years.~      We aim to assess the effectiveness of an exercise-based prevention program to reduce~     football-related injuries in children younger than 13 years.~      The primary outcome in this study is the overall injury rate. Secondary outcomes are the rate~     of severe injuries and acute injuries.~      The study is designed as a two-armed cluster-randomized controlled trial. We will recruit 9~     to 12 years old children (boys and girls, born 2002 to 2005) participating in regular~     training and match play in an officially registered football club in Switzerland (further~     study centres are located in the Netherlands, Germany and the Czech Republic). The chosen age~     group is usually subdivided into two age categories (9/10 years, 11/12 years).~      Recruitment will take place via the national and regional football associations.~      Inclusion criteria are: the clubs must be officially registered in the regional football~     association, children must be between 9 and 12 years old at the start of the study and~     regular training must take place at least twice per week. Teams will be excluded, if the~     coaches already perform a structured warm-up focusing on neuromuscular control or an existing~     injury prevention programme.~      Injury surveillance will include a baseline questionnaire, players´ exposure and injury~     registration. Anthropometric baseline data and information regarding previous~     football-related injuries will be obtained prior to the start of the study from the parents.~     Injury and exposure surveillance will be assisted by an automated internet-based injury~     recording system which has been developed and applied during our own epidemiological project.~      For all participating teams, one contact person will be appointed. Those persons will be~     provided with exact instructions on injury definitions as well as examples how to complete~     the injury and exposure forms within the online injury recording system.~      If an injury occurred, one trained person will contact the coach as well as the player and~     the parents by telephone and/or e-mail to assess all relevant aspects of the injury based on~     a standardized injury registration form. In case of injuries which require medical treatment~     parents will be supported to receive the exact diagnosis from the attending physician (either~     as specific written diagnosis or by use of a specific injury coding system). Two blinded~     investigators will additionally assess all information with regard to each injury to allow~     for objective and independent injury surveillance.~      20 study assistants and 4 scientific assistants will support coaches with data collection and~     injury recording. Each study assistant will be responsible for eight clubs. Study assistant~     will regularly keep in touch with the clubs and will visit two training sessions of each team~     during the study period.~      The intervention period will last one complete season. The injury prevention program will be~     included at the beginning of the usual football training by replacing the traditional~     warm-up. The programme will be conducted at least two times a week by the intervention teams.~     The prevention programme contains seven exercises and lasts about 10 to 15 min after~     familiarisation. Three exercises focus on unilateral, dynamic stability of the lower~     extremities (hopping, jumping and landing). Further, three exercises emphasize whole body and~     trunk stability. The last exercise contains rolling movements to improve fall technique.~      The coaches of the control group will receive the instruction to regularly perform a common~     warm-up consisting of running and ball-based exercises (sham treatment, no neuromuscular and~     stability exercises).~      The yearly incidence injured players in children is 8.6%. A risk reduction of one third has~     been recently acknowledged as a relevant effect size for injury rate. This corresponds to a~     reduction of the yearly incidence to 5.8% injured players. In order to achieve a statistical~     power of 80% and taking an allocation ratio of 1:1 and a cluster-inflation factor of 1.7 into~     account, in total 4´000 players are needed for statistical analysis. Assuming a realistic~     drop-out rate of about 33%, 6´000 children will be initially recruited.~   "
102782|NCT02222012|"~     The investigators propose a multi-source pattern which integrates neuroimaging data~     associated with multiple, symptom-related neural processes relevant in depression to improve~     classification accuracy. The investigators conclude that combining brain activation related~     to the core-symptoms of depression using the multi-source monitoring data substantially~     increases classification accuracy while providing a sparse relational neuromarkers-model for~     future prediction.~   "
102783|NCT02221999|"~     The investigators hypothesize that paclitaxel combined with cisplatin in a weekly-based~     regimen as neoadjuvant chemotherapy is effective and tolerable for locally advanced breast~     cancer.~      In patients with some sub-type advanced breast cancer, neo-adjuvant chemotherapy combined~     with endocrine therapy may improve the pathological remission rate.~      Premenopausal patients with triple negative breast caner and hormonal receptor positve breast~     cancer patients will be randominzed to have neoadjuvant chemotherapy combined with endocrine~     therapy or not.~   "
102784|NCT02221986|"~     The results of the present RCT study will add to the growing body of literature investigating~     the potential role of exercise as a supportive therapeutic intervention for patient with~     glioma.~   "
102785|NCT02221973|"~     The aim of LipiDown (Hawthorn + Phytosterol) clinical trial is to test the blood lipids~     reduction effect of plant sterols and hawthorn in milk powder in a pilot human trial:~     demonstrate potential to reduce total blood cholesterol more than 10% and/or total~     triglycerides more than 15%, as required by State food and drug administration (SFDA)~     regulation.~   "
102786|NCT02221960|"~     To evaluate MEDI6383 when given alone or together with MEDI4736 in adult subjects with~     recurrent or metastatic solid tumors.~   "
102787|NCT02221947|"~     This study is being done to evaluate the safety, tolerability and potential effectiveness of~     a new investigational drug, bryostatin 1, in patients with Alzheimer's disease (AD).~   "
102788|NCT02221934|"~     The purpose of the clinical trial is to learn whether electrical nerve block via the Altius~     System is a safe and effective treatment for patients with post-amputation pain.~   "
102789|NCT02221921|"~     The objective of this study is to evaluate the safety and effectiveness of the MicroPort's~     Valve and delivery system for transcatheter aortic valve implantation (TAVI) in severe aortic~     stenosis who are considered unsuitable for Surgical Valve Replacement.~   "
102790|NCT02221908|"~     The goal of this study is to assess decision making skills of emergency physicians when~     dealing with hypotensive patients. The hypothesis is that decisions made based on physical~     exam and vital signs regarding fluid resuscitation by emergency physicians are not~     statistically equivalent to those that would be made based on the use of a non-invasive CVP~     measurement~   "
102791|NCT02221895|"~     The study's purpose is to determine if early (2-3 week) versus traditional (6-8 week)~     postpartum follow up is associated with a higher rate of breastfeeding at 6 months. The~     study's hypothesis is that follow up at 2-3 weeks postpartum is associated with a higher rate~     of breastfeeding 6 months postpartum.~   "
102792|NCT02221882|"~     The main purpose of this study is to evaluate the safety of a study drug known as LY3164530~     in participants with cancer that is advanced and/or has spread to another part(s) of the~     body.~   "
102793|NCT02221869|"~     The purpose of this trial is to assess the efficacy and safety of Xyrem in pediatrics~     subjects with narcolepsy that includes cataplexy.~   "
102911|NCT02220335|"~     A number of 100 patients with pulmonary hypertension associated with the left Heart failure~     scheduled for elective pulmonary arterial denervation (PADN) are randomized 1:1 to either~     PADN or control group.~   "
102794|NCT02221856|"~     Technological advances have made computer aided orthodontic treatment planning possible. 3D~     dental scanners and software make it possible to design and approve the outcome before~     treatment begins. Manufacturers have provided different customized appliance systems that~     would help practitioners achieve those computer-designed outcomes. The purpose of this study~     is to determine the accuracy of computer-guided indirect bonding of orthodontic brackets at~     achieving the predicted alignment and comparing that to the accuracy of conventional~     orthodontic bracket placement at achieving a predetermined goal. The results of this study~     will help orthodontists and patients know if there is an advantage to using custom~     appliances. The study will be a prospective clinical study and will include a total of 60~     arches from 30 patients enrolled at the Harvard School of Dental Medicine. 15 patients will~     be assigned to each of the two study groups (Motion View or control). Both groups will have a~     3D intra-oral scan to measure the initial discrepancy and determine the computer-simulated~     design that the orthodontist believes is the optimized outcome. At the end of each patient's~     participation, a 3D intraoral scan will be taken and used to assess intra-arch leveling and~     alignment using ABO's objective grading system's criteria for alignment, marginal ridges and~     buccolingual inclination. Each arch will then be superimposed on the predicted outcome to~     determine how accurate each system was at achieving the planned movements in all 3~     dimensions. We hypothesize that the accuracy of computer-guided indirect bonding (Motion~     View) at achieving the predicted outcomes will differ in comparison to the accuracy of~     conventional orthodontic bracket placement at achieving a predetermined goal.~   "
102795|NCT02221843|"~     Sunbit is a new wearable UV dosimeter to measure solar radiation in real time. The purpose of~     this study is to track sun behavior of patients at high risk for skin cancer, to investigate~     the feasibility of this prototype in daily life and to investigate the technical accuracy of~     the Sunbit.~   "
102796|NCT02221830|"~     Evaluation of the efficacy of postpartum 24 hour oxytocin infusion to reduce blood loss in~     patients with pre-eclampsia (PE)~   "
102797|NCT02221817|"~     Trochanteric bursitis is a common condition, effecting 20% of the population. \Most with~     trochanteric bursitis experience chronic intermittent or continuous hip pain at and around~     the greater trochanter.~      The cause of trochanteric bursitis is believed to be a result of inflammation of the bursa,~     though this has not been confirmed. Accordingly, the use of corticosteroid injections has~     been shown to provide considerable relief. However, routine blind injections, those~     performed without the aid of imaging, such as fluoroscopy, have shown limited success in the~     appropriate needle placement. Fortunately, blind injections have yielded positive results in~     majority of the cases. Additionally, the use of fluoroscopy has not shown to improve clinical~     outcome for trochanter bursa injections.~      Although the use of fluoroscopy has not shown positive benefit, other modes of imaging, such~     as ultrasound have not been studied and may be more useful. Fluoroscopy allows for~     bony-landmark based injections. Ultrasound allows for direct visualization of the soft tissue~     structures such as the bursa and has gained significant support for use in musculoskeletal~     injections. This prospective blinded study's aim is to evaluate, if any, the benefit of an~     ultrasound guided injection and whether ultrasound should be routinely used during trochanter~     bursa injections.~   "
102798|NCT02221804|"~     Chronic Obstructive Pulmonary Disease (COPD) is the most common pulmonary disease,~     responsible for considerable morbidity and mortality and is the third leading cause of death~     worldwide. As well as its consequences in the lungs, COPD is well recognized to be associated~     with a range of important systemic consequences and co-morbidities. Interestingly, skeletal~     muscle dysfunction is noted in both early and advanced disease, suggesting its origins may~     not be wholly pulmonary.~      Treatment strategies targeting lung function are, unfortunately, of limited value. Given the~     burden of disease, it is becoming increasingly important that investigative and therapeutic~     work now focuses on other systemic characteristics and sequelae which define the disease~     phenotype.~      This is a randomized controlled trial of the effect of 14 days of voluntary reduced activity~     on muscle mass, muscle strength, body composition, and atrophy signalling in patients with~     COPD and age-matched controls.~      The primary hypothesis upon which this study is based is that a short reduction in ambulation~     will induce a transient reduction in quadriceps muscle mass, quadriceps strength and physical~     performance in patients with COPD compared to matched COPD patients whose mobility has not~     been restricted.~      The secondary hypothesis is that the magnitude of the above changes will be greater in~     physically inactive COPD patients compared to physically inactive age-matched controls.~      The overall aim of this research is to use an in vivo human model of 14 days of voluntary~     reduced physical activity to test the above hypotheses. If the model proves feasible, this~     will allow for earlier proof of concept studies of novel therapeutic agents.~   "
102799|NCT02221791|"~     Intervention studies support a protective effect of flavonoid-rich foods such as chocolate~     and tea on cardiovascular disease risk. In a previous study we found that pure epicatechin~     improves markers of vascular function and insulin resistance although the results were less~     pronounced than the majority of chocolate intervention studies.~      The food matrix of chocolate or other compounds present in chocolate could play a role in the~     bioavailability of flavonoids, resulting in these heightened improvements in vascular~     function.~      In this study we aim to compare the acute effects of pure epicatechin and high-flavonoid~     chocolate on markers of vascular function.~   "
102800|NCT02221778|"~     This is a pilot study where patients with Hepatocellular Carcinoma (HCC) that have failed~     Transarterial Chemoembolization (TACE) will be treated with Stereotactic Body Radiation~     Therapy (SBRT). The focus of the study will be to evaluate safety and efficacy in our~     population of patients.~   "
102810|NCT02221648|"~     The scientific aim of this study is to investigate the efficacy of abobotulinumtoxinA~     (Dysport - Ipsen Pharmaceuticals) in chronic low back pain.~      The investigators hypothesis is that injection of Dysport brand of botulinum toxin type A~     into erector spinae muscles (extensors of the spine) can relieve low back pain through~     anti-spasm and analgesic effect of botulinum toxin.~   "
102909|NCT02220361|"~     Hemabate is often used for gynecological patients. Hemabate is associated with many side~     effects, including a burning sensation in the stomach, nausea, vomiting, diarrhea etc. It is~     reported that dexmedetomidine reduce gastrointestinal reaction during perioperative period.~     We design this clinical trial to find if dexmedetomidine can prevent the side effects of~     hemabate in Cesarean Section patients.~   "
102801|NCT02221765|"~     Obesity is a growing pandemic which affects 1 in 4 adults in the UK, and shortens life by~     increasing cardiovascular disease, diabetes and cancer. Current treatments for obesity have~     either poor efficacy or significant side effects. Pancreatic polypeptide (PP) is a promising~     new drug target as it produces powerful appetite suppression which, following a 90-minute~     infusion continues to act for 24 h in man. We have developed a new long lasting high potency~     analogue of PP, PP1420. This is delivered as a once-a-day subcutaneous injection via a~     painless fine-gauge needle.~      In a first-time-in-man Phase 1a trial, that PP 1420 proved safe, well tolerated, and had~     extended pharmacokinetics compared to PP itself.~      We now plan to study the safety and PK of PP1420 up to 64mg. We will also assess:~        1. Its efficacy in reducing food intake after a single dose in a Phase 1B study in healthy~          volunteers.~        2. Its efficacy in reducing food intake and weight after multiple dosing in a Phase 1C~          study in healthy volunteers.~   "
102802|NCT02221752|"~     According to a national study in 2002, the prevalence of ID, IDA, and ID+IDA among pregnant~     women in China was 42.6%, 9.1%, and 61.7% respectively. A similar study in Hebei province at~     the same time showed that the prevalence of IDA among pregnant and lactating mothers was~     46.39% and 47.21% respectively. There was a significant difference between urban and rural~     areas. Women living in rural areas had higher chances of having IDA (p<0.01). WHO and UNICEF~     recommend taking iron, folic acid and multiple micronutrients during pregnancy. However, we~     don't know much about their influence on maternal and infant health and their clinical~     effectiveness. Health Department of China recommends taking 400ug folic acid before pregnancy~     and during early pregnancy. But for various reasons, not all expecting mothers take this~     advice. Besides, we don't have a national level technical standard of how to take nutrition~     supplements during pregnancy. Therefore, it's crucial for us to study if iron/folic acid or~     folic acid only can prevent perinatal complications, as well as their influences on infant~     and toddler health.~      The purpose of this study is to test whether taking iron/folic acid and folic acid only from~     early pregnancy until delivery will lower the chances of pregnancy complications, and to see~     how supplements affect gestation results. As well, it will evaluate a) whether taking iron~     supplement during pregnancy can prevent IDA during pregnancy; b) whether taking iron~     supplement can increase mother and fetus iron storage; and c) how mother's iron level affects~     newborn's iron level. We hope to understand nutrition conditions during pregnancy and~     investigate the relations between pregnancy diet and complications during pregnancy, weight~     gain during pregnancy, and newborn birth weight. We will evaluate the influence of taking~     iron and folic acid during pregnancy on the health of infants and toddlers.~   "
102803|NCT02221739|"~     The purpose of this study is to investigate how effective and how safe the combination of~     radiation therapy and an investigational medication targeting the immune system known as~     Ipilimumab in the treatment of metastatic non-small cell lung cancer (NSCLC).~      The investigators would like to see if this combination of radiation and Ipilimumab can~     stimulate the body's immune system to stop the growth of tumors that are outside the field of~     radiation. The investigators would like see if using this combination of radiation therapy~     with Ipilimumab could help the body reject the patient's own tumor or at least help their~     immune system to maintain the disease stable and/or slow its growth.~      Radiation therapy (RT) is currently a standard procedure for treatment of NSCLC. Ipilimumab~     is considered an investigational medication because it is not approved by the Food and Drug~     Administration (FDA) for the treatment of NSCLC. Ipilimumab has been approved by the FDA for~     the treatment of metastatic melanoma.~   "
102804|NCT02221726|"~     The purpose of this study is to assess 3 different scoring systems to evaluate the adhesive~     quality of placebo (an inactive substance that is compared with a drug to test whether the~     drug has a real effect in a clinical trial]) JNJ-35685-AAA-G-023-G transdermal (through the~     skin) systems during a single system 72-hour application, replicated 3 times, of 2 patch~     sizes (5.5 centimeter^2 [cm^2] and 44 cm^2).~   "
102805|NCT02221713|"~     Colonic diverticula are outpouchings of the large bowel, and they occur in up to 60% of~     people over 60 years of age. About 10-25% of patients with diverticula will have symptoms.~     These can range from acute diverticulitis, which can be a lethal infection to symptomatic~     diverticular disease, which involves inflammation of the bowel and altered bowel habits,~     decreasing patients' quality of life. We do not know which patients will develop acute~     diverticulitis or which patients will develop diverticula in their colon.~      We believe that diverticulitis may be associated with, or even caused by, alterations in the~     bacteria that live in the colon, known as the gut microbiome. Until recently it was too~     expensive and too complex to examine the microbiome in detail. We propose to examine for the~     first time in detail the microbiome of patients with acute diverticulitis and asymptomatic~     diverticulosis.~      Stool samples will be analysed for gut microbiome composition by 16S ribosomal RNA gene~     pyrosequencing. There is a part of the bacterial cell, the ribosome, which is the same in all~     bacteria (16S). Through PCR, polymerase chain reaction, and sequencing, we can separate out~     the different types of bacteria in a sample. We can then look at the different kinds of~     bacteria in each patient population, as well as how diverse the populations are within the~     groups, and compared to other groups.~      We hope to be able to discriminate between the microbiome of patients with acute~     diverticulitis and asymptomatic diverticulosis. This study many change how diverticulitis and~     diverticulosis are conceptualized and treated. Alterations in the microbiome in these disease~     states may be able to be treated, preventing further disease.~   "
102806|NCT02221700|"~     The goal of this research study is to compare the level of effectiveness of two massage~     treatment schedules for chronic CIPN in people treated with Oxaliplatin or taxanes~     (docetaxel, paclitaxel) for their cancer (breast and gastrointestinal) . Researchers also~     want to study how participants may respond to massage treatments, and how the treatments may~     affect quality of life and physical performance.~   "
102807|NCT02221687|"~     The primary objective of this study is to demonstrate that a synbiotic formula, fed for the~     duration of the first year of life (infant and follow-on formula) reduces the incidence rate~     of episodes of infectious diarrhea in infants during the first year of life compared to a~     standard infant formula.~   "
102808|NCT02221674|"~     This is a multicenter, open-label (all people involved know the identity of the~     intervention), single dose trial to evaluate the pharmacokinetic (PK) profile (how drugs are~     absorbed in the body, how are they distributed within the body and how are they removed from~     the body over time) in children aged from birth to less than 2 years after a surgical~     procedure that routinely produces moderate to severe acute post-surgical pain.~      The trial will also evaluate the safety and tolerability of tapentadol oral solution in the~     population studied and the effect of tapentadol oral solution on pain.~   "
102809|NCT02221661|"~     The purpose of this study is to assess the performance of AclarusDx™, an investigational~     blood test detecting gene expression information, and intended to help physicians in making~     an Alzheimer's Disease diagnosis in patients having memory complaint and/or cognitive~     impairments.~   "
102912|NCT02220322|"~     Age-related change of femur is not well-known. The investigators investigated the~     longitudinal changes of femur.~   "
102811|NCT02221635|"~     The purpose of this study is to evaluate the efficacy of repetitive transcranial magnetic~     stimulation in the prevention of relapse of the symptoms of schizoaffective disorder. Primary~     Outcome Measures:Time between subject randomization to treatment and the first occurrence of~     a relapse during the Relapse Prevention Period. Secondary Outcome Measures: Symptom change as~     measured by the Positive and Negative Syndrome Scale (PANSS) total and PANSS factor scores;~     Illness severity change as measured by Clinical Global Impression of Severity for depression~     (CGI-S-DEP); Change in subject functioning using the Personal and Social Performance Scale;~     Change in subject medication satisfaction using the Medication Satisfaction Questionnaire~     (MSQ).~   "
102812|NCT02221622|"~     The purpose of this study is to evaluate the safety and tolerability of allopregnanolone, a~     naturally occurring brain steroid, in mild cognitive impairment and early Alzheimer's disease~     participants. The primary goal is to determine the maximally tolerated dose.~   "
102813|NCT02221609|"~     The objective of this study is to investigate the efficacy of a treatment based on Movement~     System Impairment based classification (MSI) model in patients with chronic non-specific low~     back pain.~   "
102814|NCT02221596|"~     The purpose of this study is to identify the magnitude of muscle lipid redistribution and~     muscle oxygen use in individuals 60 years old or older following combined treatment of~     vitamin D repletion and aerobic training compared to vitamin D repletion alone, aerobic~     training alone, or no treatment.~   "
102815|NCT02221583|"~     The purpose of this study is to evaluate how quickly and to what extent different~     immunosuppressants are absorbed into the blood (this is called pharmacokinetics) in renal~     transplant candidates who have undergone a laparoscopic sleeve gastrectomy. The immune system~     is the body's defense against diseases. It also attacks foreign tissues such as a~     transplanted kidney. Immunosuppressant medications such as Astagraf sustained release (XL),~     Prograf, and mycophenolate mofetil may be given to suppress the immune system following~     kidney transplantation and prevent rejection of a transplanted kidney. This study is being~     performed to determine if patients who undergo laparoscopic sleeve gastrectomy need different~     doses of immunosuppressant medications.~   "
102816|NCT02221570|"~     Patients with cirrhosis often experience muscle cramps with varying severity. The mechanism~     of their occurrence is not yet understood. Muscle cramps in patients with cirrhosis are~     associated with significantly diminished quality of life.~      The aim of the study is to assess the efficacy of baclofen in the treatment of muscle cramps~     in patients with liver cirrhosis.~   "
102817|NCT02221557|"~     A case series to compare the handling and effectiveness of two different treatment approaches~     using a new alloplastic bone graft material in ridge preservation compared to allograft~     existing historical data.~   "
102818|NCT02221544|"~     This study is a double blind comparative study examining the effectiveness of the rTMS~     treatment on Freezing of Gait (FOG) phenomenon in patients with Parkinson's disease. We~     hypothesize that treatment using rTMS stimulation on frontal lobe areas will improve gait~     quality and decrease the frequency of FOG in patients with Parkinson's disease.~   "
102819|NCT02221531|"~     Postpartum haemorrhage (PPH) is an obstetric emergency and defined as a blood loss of ≥500ml~     after vaginal birth and ≥1000ml after caesarean section (CS) and/or the need for blood~     transfusion within 24 hours after delivery (World Health Organization, Recommendations for~     the Prevention of Postpartum Haemorrhage. 2007; Leduc et al., J Obstet Gynaecol Can, 2009).~     Since PPH is more common after caesarean deliveries than after vaginal births and the rate of~     CS is rising over time and will probably continue to rise, the incidence of PPH is expected~     to increase accordingly.~      A meta-analysis has shown that routine administration of an oxytocic agent after caesarean~     delivery leads to a reduced blood loss and decreases the risk of PPH (Cotter et al., Cochrane~     Database Syst Rev, 2001). The two most commonly used oxytocic drugs after operative delivery~     are oxytocin and carbetocin, a synthetic oxytocin-analogue. Carbetocin has the advantage over~     oxytocin of having a longer half-life and therefore reducing the use of additional~     uterotonics. Based on the findings of reduced cardiovascular side-effects with a~     short-infusion as compared to a bolus injection found for oxytocin (Thomas et al., Br J~     Anaesth, 2007), our study hypothesis is that a slower administration rate of carbetocin~     minimises the cardiovascular side effects without compromising the uterine tone. Therefore,~     we aim to investigate a short infusion of carbetocin 100 mcg applied in 100ml sodium chlorid~     compared to a bolus application in women undergoing primary or secondary caesarean delivery.~     This prospective, double-blind, randomised controlled non-inferiority trial will take place~     at the University Hospital Basel, Switzerland. We hypothesize uterine contraction not to be~     inferior (primary efficacy endpoint) and the mean arterial pressure to be higher after a~     short-infusion than after a bolus administration (primary safety endpoint).~   "
102820|NCT02221518|"~     The purpose of this study is to examine the brain functioning of OCD patients and healthy~     controls before and after treatment with Exposure and Response Prevention (EXRP) therapy.~   "
102821|NCT02221505|"~     LOP628 is an antibody-drug conjugate (ADC) consisting of an anti-cKit humanized IgG1/κ~     antibody conjugated to a maytansine payload via a non-cleavable linker.~      LOP628 provides an opportunity to target cKit overexpressing tumors.~   "
102822|NCT02221492|"~     Primary Objective:~      To determine if non-Hodgkin Lymphoma (NHL) participants mobilized with granulocyte~     colony-stimulating factor (G-CSF) plus plerixafor 240 μg/kg are more likely to achieve a~     target number of greater than or equal to 5 x 10^6 cluster differential (CD) 34+ cells/kg in~     4 or fewer days of apheresis than NHL participants mobilized with G-CSF alone.~      Secondary Objectives:~        -  To evaluate the safety of G-CSF plus plerixafor arm compared to G-CSF arm in NHL~          participants.~        -  To compare the 2 treatment arms with respect to the number of participants who achieved~          a minimum of 2 x 10^6 CD34+ cells/kg in 4 or fewer days of apheresis.~        -  To compare the 2 treatment arms with respect to the number of days of apheresis required~          to reach the target of greater than or equal to 5 x 10^6 CD34+ cells/kg.~   "
102823|NCT02221479|"~     Primary Objective:~      To determine if Multi Myeloma (MM) patients mobilized with granulocyte colony-stimulating~     factor (G-CSF) plus plerixafor 240 μg/kg are more likely to achieve a target number of~     greater than or equal to 6 x 10^6 cluster of differentiation (CD) 34+ cells/kg in 2 or fewer~     days of apheresis than MM patients mobilized with G-CSF alone.~      Secondary Objectives:~        -  To evaluate the safety of G-CSF plus plerixafor arm compared to G-CSF arm in MM~          patients.~        -  To compare the 2 treatment arms with respect to the number of participants who achieved~          a minimum of 2 x 10^6 CD34+ cells/kg in 4 or fewer days of apheresis.~        -  To compare the 2 treatment arms with respect to the number of days of apheresis required~          to reach the target of greater than or equal to 6 x 10^6 CD34+ cells/kg.~   "
103988|NCT02206243|"~     The purpose of this observational study is to evaluate the prostatic arterial embolization~     (PAE) with Embozene® Microspheres (Boston Scientific) in sphere sizes of 250 µm for the~     treatment of symptomatic benign prostatic hyperplasia (BPH).~   "
102825|NCT02221453|"~     Diabetic macular edema refers to swelling (fluid accumulation) in the center of the retina.~     The retina is like the film of a camera and is located in the back of the eye. This condition~     can develop in diabetics where swelling results from leaking of fluid from the blood vessels~     of the eye, into the center of the retina, the macula. If left untreated, this can affect~     central vision. The current standard treatment for diabetic macular edema includes~     medications injected directly into the eye (intravitreal injections) and laser eye treatment.~     The drugs that are injected directly into the eye are known as anti-Vascular Endothelial~     Growth Factor (anti-VEGF) agents which help to reduce the leaking. This includes bevacizumab~     (Avastin®) and ranibizumab (Lucentis®).~      However, some patients do not respond well to these anti-VEGF treatments will be given the~     option of switching to an another class of medications, called steroids. Triamcinolone~     acetonide is one of these steroids and is also injected directly into the eye. These steroids~     will help reduce inflammation and possibly as a consequence, reduce swelling in the eye.~      The purpose of this study is to determine what cellular factors affect a patient's treatment~     response (amount of swelling reduction) following triamcinolone acetonide intravitreal~     injections for diabetic macular edema.~   "
102826|NCT02221440|"~     Supplementary oxygen is routinely administered to patients, even those with adequate oxygen~     saturations, in the belief that it increases oxygen delivery. However, oxygen delivery~     depends not just on arterial oxygen content but also on perfusion.~      Maternal oxygen administration has been used in an attempt to lessen fetal distress by~     increasing the available oxygen from the mother. However, the effect of supplemental maternal~     oxygen therapy on fetal acid base status has been debated for more than seven decades.~      Hypothesis: Prophylactic maternal low flow nasal oxygen administration during the second~     stage of labor can relieve fetal distress.~   "
102827|NCT02221427|"~     The purpose of this study is to evaluate if the rate of emergency caesarean section can be~     reduced if adhering to a dynamic labour progression curve compared to a static progression~     curve for first time mothers without jeopardising maternal and neonatal outcomes~   "
102828|NCT02221414|"~     Study to demonstrate bioequivalence of a 2.5 mg linagliptin / 500 mg metformin fixed dose~     combination (FDC) tablet compared to single tablets of linagliptin 2.5 mg and metformin 500~     mg administered together~   "
102829|NCT02221401|"~     Study to demonstrate bioequivalence of a 2.5 mg linagliptin/1000 mg metformin fixed-dose~     combination (FDC) tablet compared with single tablets of linagliptin 2.5 mg and metformin~     1000 mg administered together.~   "
102830|NCT02221388|"~     To compare the oral bioavailability and rate of absorption of two different formulations of~     BI 671800 HEA (choline salt) tablets 200 mg, one with enteric coating (EC) and one without~     EC, versus 2 x 100 mg BI 671800 ED (ethylenediamine salt) capsules. Both BI 671800 HEA~     formulations were further investigated concerning food effect and one of the two BI 671800~     HEA formulations identified by interim pharmacokinetic analysis was further investigated~     concerning dose proportionality with 50 mg.~   "
102831|NCT02221375|"~     The objective of the study was to investigate safety, tolerability and pharmacokinetics of~     butylated hydroxytoluene (BHT) (sub-study 1) administered via Respimat® Soft MistTM Inhaler B~     (SMI B); to assess safety, tolerability and pharmacokinetics of multiple rising doses of BI~     54903 XX administered via Respimat® SMI B (main study), and to compare systemic exposure of~     single dose BI 54903 XX administered via Respimat® SMI B (sub-study 2) with single dose~     Alvesco® (ciclesonide) administered via HFA-134a propellant metered dose inhaler (MDI).~   "
102832|NCT02221362|"~     Study 701-901, a multicenter, multinational, longitudinal, non-interventional observational~     study in subjects, at least 18 years old, diagnosed with late-onset Pompe disease~     prospectively collects data to understand clinical progression in terms of respiratory~     function, symptomology, genotype, biochemistry, endurance and selected subject-reported~     measures for 24 weeks followed by a 240 week additional observation period for up to 100~     subjects.~   "
102833|NCT02221349|"~     This study will compare the safety and effectiveness of normal oral hygiene with two~     different marketed dentifrices, on longer term dentinal hypersensitivity response following~     use of potassium oxalate desensitizers.~   "
102834|NCT02221336|"~     Bipolar disorder is associated with a high risk of relapse and hospitalisation and many~     patients do not recover to their previous psychosocial function. Major reasons for poor~     outcomes are delayed intervention for prodromal depressive and manic symptoms as well as~     decreased adherence with treatment.~      Recently, in the MONARCA I trial (NCT01446406), the investigators developed and deployed a~     smartphone based self-monitoring system (the MONARCA I system) in a randomized controlled~     trial, to test the effect of daily reporting of subjective self-monitoring of depressive and~     manic symptoms as well as a bi-directional feedback loop on depressive and manic symptoms.~      In the MONARCA II trial the investigators will develop and deploy a new version of the~     smartphone based monitoring system. The investigators will in a randomized controlled single~     blind trial investigate whether daily electronic monitoring of subjective and objective~     measures of illness activity using a smartphone based self-monitoring system including~     feedback on subjective as well as automatically generated objective data (e.g.social~     activity, physical activity etc.) (the MONARCA II system) reduces the severity of depressive~     and manic symptoms and improves functioning more than a control group receiving a smartphone.~     All patients will be followed for 9 months with outcome assessments at baseline, after 4~     weeks, after 3 months, after 6 months and after 9 months.~   "
102835|NCT02221323|"~     The aim of this trial is to compare the pharmacokinetics and pharmacodynamics of insulin~     lispro injection into either lipohypertrophic lesions or normal tissue, utilizing both~     state-of-the-art euglycaemic clamp and mixed meal tolerance testing. The magnitude of insulin~     efficacy after injection into these different areas is still unclear. The results from this~     study may expand the knowledge on the severity of this issue and may provide evidence for~     future treatment recommendations regarding injection sites for insulin administration.~   "
102836|NCT02221310|"~     Targeted immune therapy with gemtuzumab ozogamicin (Mylotarg) in combination with~     chemotherapy followed by allogeneic stem cell transplantation will be given to patients with~     high risk acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS).~   "
102837|NCT02221297|"~     Purpose of the study is to determine the effect of the investigational products as consumed~     with a meal on serum lipids, primarily on LDL cholesterol.~   "
102838|NCT02221284|"~     The purpose of this survey is to evaluate the safety and efficacy of long-term use of~     alogliptin tablets (Nesina Tablets) in type 2 diabetic patients who have had an inadequate~     response to hypoglycemic agents (e.g., insulin preparations or rapid-acting insulin~     secretagogues)* in addition to dietary/exercise therapy in daily medical practice.~      * Patients receiving these hypoglycemic agents (excluding α-glucosidase inhibitors,~     thiazolidines, sulfonylureas, and biguanides) were excluded from existing specified drug-use~     surveys for Nesina Tablets.~   "
102839|NCT02221271|"~     Patients diagnosed with Guillain-Barré syndrome were confirmed based on the diagnostic~     criteria for Guillain-Barré syndrome. Patients who meet all inclusion criteria and do not~     conflict with the exclusion criteria will receive NPB-01 (intravenous immunoglobulin)~     400mg/kg/day for five consecutive days.~      Patients evaluate the Functional Grade（FG） and Arm Grade（AG） et al.~      As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse~     events by the start of the study treatment.~   "
102840|NCT02221258|"~     The purpose of phase 1 clinical trial is to to evaluate safety in subjects with moderate to~     severe rheumatoid arthritis after infusion.~   "
102841|NCT02221245|"~     Cancer results when undifferentiated cells grow in an uncontrolled manner, crowding out~     normal cells, causing morbidity and ultimately mortality. the cancer stem cell theory~     suggests that most tumors undergo a process of differentiation through which a relatively~     rare cancer stem or progenitor cell (CSC) gives rise to more differentiated populations of~     cells (including transiently amplifying cells) comprising the bulk of the tumor. As a result~     of this cellular diversity, one or more cells within the tumor are likely to be resistant to~     therapy. Among cells resistant to a given therapy, only CSCs can repopulate the tumor. A key~     feature of this resistant subset of CSCs is that they repopulate a tumor resistant to the~     original intervention. The cellular programs driving the uncontrolled proliferation of many~     solid tumors result from aberrant activity of Wnt, Shh, and/or Notch signaling pathways in~     esc. Thus, therapies that down-regulate the activity of these fundamental pathways in CSCs~     will be effective in the treatment of cancer. The investigator's research program focuses on~     the elucidation of signaling mechanisms, control of cellular processes and discovery of small~     molecules that selectively target Wnt, Shh, and Notch signaling pathways that are fundamental~     to CSCs. Our preliminary results identified a novel Notch associated protein NACK that~     functions as a transcriptional co-activator of Notch. Moreover, Nack is expressed in human~     solid tumors and is required for cell survival and tumor growth in notch -dependent tumor~     cells.~      The investigator's aim is to further interrogate the link between Notch and Nack.~      Specific Aims:~        -  Identify and isolate the cancer stem cell populations from primary chemo naive~          esophageal tumor samples.~        -  Interrogate the status of the Notch,( the link between Notch and Nack), Wnt and Hedghog~          pathways in the chemo naive esophageal tumor as well as in specific cell populations,~          such as the CSC.~        -  Determine the degree of cross-talk between these pathways and which of these pathways is~          essential for the self renewal properties and tumorigenic properties of the esc~          population.~        -  Identify critical targets for therapeutic intervention in CSC populations.~   "
102842|NCT02221232|"~     The purpose of this pilot study is to evaluate antimicrobial properties of a single test~     product, a vehicle product and a reference product applied in two different areas when used~     as a patient preoperative skin preparation.~   "
102843|NCT02221219|"~     Intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL) are brain lesions~     that commonly occur in preterm infants and are well-recognized major contributors to~     long-term brain injury and related disabilities later in life. Despite its prevalence, long~     term consequences, and enormous medical and social costs, mechanisms of IVH and optimal~     strategies to prevent or treat its occurrence are poorly defined, especially for extremely~     premature infants. Only one medical therapy, prophylactic indomethacin during the first 3~     days of life, has been shown to prevent or decrease the severity of IVH in preterm infants,~     but its use is limited by toxic side effects and debatable effects on long-term outcomes.~     Several small studies and case reports suggest that delayed umbilical cord-clamping (DCC) may~     also decrease the incidence of IVH in premature infants, but thus far these trials have~     indomethacin treatment mixed within their cord clamping protocols. The investigators are~     conducting a randomized, blinded investigation of 4 treatment groups: 1) Control (no~     intervention); 2) DCC alone; 3) Prophylactic indomethacin alone; 4) Combination of~     DCC/indomethacin, with respect to survival, IVH or PVL incidence and severity,~     neurodevelopmental outcomes, and relevant mechanistic effects. With the steady rise in~     extreme prematurity births and clear links of IVH to long-term disabilities there is a need~     to improve care for these patients. This multi- disciplinary project addresses an important~     medical problem for an understudied patient population, where the current practice has clear~     limitations.~   "
102844|NCT02221206|"~     The intended study is designed as a prospective randomized controlled trial (RCT), comparing~     and contrasting the effect of mini-screw implant anchorage-assisted versus regular maximum~     anchorage by retracting the maxillary incisors.~   "
102845|NCT02221193|"~     Objectives: To determine whether site-specific mouth rinsing with oral disinfectants can~     improve oral odor beyond the traditional panoral mouth disinfection with mouth rinses by~     targeting specifically oral malodor implicate anaerobic bacteria.~      Methods: Twenty healthy fasting subjects volunteered for a blinded prospective, descriptive~     correlational crossover cross-section clinical trial conduct during the month of Ramadan in~     the lunar Hajri year 1434 AH (10 July 2013-8 August 2013) in Albaha province in Saudi Arabia~     involving the application of Listerine® Cool Mint® mouth rinse by either the traditional~     panoral rinsing method or a site-specific disinfection method targeting the subgingival and~     supragingival plaque and the posterior third of the tongue dorsum while avoiding the~     remaining locations within the oral cavity. The viable anaerobic and aerobic bacterial~     counts, volatile sulfur compounds (VSCs) levels, organoleptic assessment of oral odor and the~     tongue-coating index were compared at baseline, 1, 5 and 9 hours after the treatment.~   "
102846|NCT02221180|"~     The purpose of this study is to evaluate the bioequivalence of metformin component of the~     canagliflozin and metformin immediate release (IR) fixed dose combination (FDC) tablet~     compared with the metformin IR tablet co-administered with canagliflozin in healthy fed and~     fasted participants.~   "
102871|NCT02220855|"~     Thymic tumors are rare tumors, but represent the most common tumors of the anterior~     mediastinum. Thymoma has an indolent course in advanced disease and has the propensity to~     spread to the pleura. In first line therapy, combination chemotherapy produces responses in~     approximately 80% of patients. A number of single agents have activity in recurrent disease,~     but none are curable. Patients with recurrent thymoma have limited treatment options, and~     thus novel target modalities are needed.~      At the Indiana University Simon Cancer Center (IUSCC), more patients with advance thymoma are~     seen than any other institution in the country. Our main hypothesis is the PI3K pathway is an~     important driver for growth and metastasis of thymoma and that inhibition of the PI3K pathway~     is expected to produce clinically meaningful response in patients with recurrent thymoma.~   "
103989|NCT02206230|"~     This study is being done to compare standard radiation therapy with hypofractionated~     radiation therapy for patients with newly diagnosed glioblastoma~   "
102847|NCT02221167|"~     This study is a randomized controlled trial seeking to determine whether supplementing~     infants at risk for excessive neonatal weight loss with a small volume of human donor milk~     prophylactically in the first 1-3 days of life, before maternal mature milk production~     (before mom's milk comes in) will decrease the incidence of formula use at 1 week and 1, 2,~     and 3 months of life and increase the rate of exclusive breastfeeding in this high-risk~     population.~      We hypothesize that supplementation of term infants who have lost greater than or equal to 5%~     birth weight by 36 hours of age with a small volume of donor breast milk following feeds,~     until mature milk production, will result in decreased supplemental formula use at 1 week and~     increased exclusive as well as any breastfeeding at 1 week and 1, 2, and 3 months. This~     study's specific aims are to compare the effectiveness of encouraging in-hospital exclusive~     breastfeeding with offering early small-volume donor milk supplementation in a population of~     infants at risk for excessive neonatal weight loss with goals of 1) decreasing the incidence~     of formula supplementation at 1 week of life and 2) improving breastfeeding duration.~   "
102848|NCT02221154|"~     The original mechanism of action of myo-inositol and preliminary results available in the~     literature on its use in IVF suggest its value as adjuvant gonadotropin therapy to reduce the~     risk of OHSS in PCOS patients.~      The aim of the study is to demonstrate that administration of myo-inositol decreases the~     incidence of ovarian hyperstimulation syndrome (OHSS) in high-risk infertile with PCOS~     supported in IVF patients.~   "
102849|NCT02221141|"~     The purpose of this study is to determine the prevalence in Belgium of Fabry disease in~     patients with unexplained hypertrophic cardiomyopathy measured by echocardiography and to~     determine in Fabry patients which was the most frequently initial symptom.~      Actually the early diagnosis is important because a treatment exists that can prevent future~     complications.~   "
102850|NCT02221128|"~     A prospective, single centre, single arm study designed to collect clinical data on PerClot~     when used in subjects undergoing endoscopic sinus surgery.~   "
102851|NCT02221115|"~     Patients seen in the Orthopaedic Trauma clinic will be asked to consent for potential~     video/picture recording using the Google Glass device during their visit with the orthopaedic~     surgeon or resident.~      The investigators want to record the patient's level of acceptance and response to this new~     technology. There are two arms: Patients seen by a doctor wearing the Google Glass device and~     those that will not be exposed. Both groups will be asked to complete a survey after their~     clinic visit.~      The device users (doctor) will complete a survey which will evaluate how effective this new~     tool is in the Orthopaedic clinical setting.~   "
102852|NCT02221102|"~     Transient ischemic attack (TIA) or minor ischemic stroke has a high risk of early recurrent~     stroke. As the golden standard, aspirin effect modestly on acute ischemic stroke, and~     slightly increase the risk of intracerebral hemorrhage. Recently, edoxaban, a new oral~     anticoagulant, is proved to be as effective as traditional anticoagulants, while carrying~     significantly less risk of intracranial hemorrhage.~      This trial is a randomized, double-blind, multicenter, controlled clinical trial in China.~     The investigators will assess the hypothesis that a 30-days edoxaban regimen is superior to~     aspirin alone for the treatment of high-risk patients with acute nondisabling cerebrovascular~     event.~   "
102853|NCT02221089|"~     Oxidative stress has been implicated to play a pathogenic role in many disease processes,~     especially in age-related disorders such as age-related macular degeneration. It has been~     hypothesized that antioxidative agents such as vitamins and minerals, which are capable of~     scavenging free radicals, may reduce oxidative stress and may, in turn, be beneficial for~     patients with age-related disorders. Based on this hypothesis several different combinations~     of vitamins have been introduced, all targeting at reducing oxidative stress. However, the~     in-vivo effect of the antioxidative properties of a certain drug or vitamin combination is~     hard to investigate. In the current study, we propose to investigate the effect of Retaron®,~     a combination of carotoinoids, omega-3-fatty acids, a herbal extract of Aronia, vitamins and~     trace elements, in a systemic in-vivo inflammation model.~      In the present study, the infusion of LPS, which is a cell wall component of gram-negative~     bacteria and a major mediator in the pathogenesis of septic shock, will be used as a~     standardized experimental model of systemic inflammation in humans. Given that inflammation~     is associated with enhanced oxidative stress and widespread endothelial dysfunction, the LPS~     model is well suitable for determination of the antioxidative effects of Retaron®. As a main~     outcome parameter the vascular reactivity of retinal vessels to systemic hyperoxia (induced~     by breathing 100% oxygen) will be tested in presence or absence of the antioxidant~     combination.~   "
102854|NCT02221076|"~     The protocol aims at demonstrating the technical feasibility and safety of doing~     endomicroscopic imaging (both probe-based confocal laser endomicroscopy (pCLE) and~     needle-based confocal laser endomicroscopy, nCLE) during colposcopy, hysteroscopy, and~     surgical procedures (open surgery and laparoscopic robot assisted or not) to examine all~     pelvic tissues including cervix, uterus, adnexia, peritoneum, normal and pathologic aspect.~   "
102855|NCT02221063|"~     The purpose of this study is to determine whether consumption of thiamin fortified fish sauce~     over 6 months increases the thiamin status of women to a level consistent with a low risk of~     infantile beriberi. The investigators hypothesize that consumption of thiamin-fortified fish~     sauce will increase red blood cell thiamin concentrations, an indicator of thiamin status, in~     women consuming thiamin-fortified fish sauce, while concentrations will not change in women~     consuming a placebo fish sauce that does not contain thiamin.~   "
102856|NCT02221050|"~     A study conducted in the laboratory revealed the existence of a window during which~     patients with renal failure appreciate the protein-rich foods. This period, located~     immediately after the dialysis, is likely related to the purification of plasma products~     resulting from protein catabolism. It therefore appears necessary to understand the~     mechanisms that may explain these changes by measurements of ghrelin (orexigenic hormone),~     leptin (anorectic hormone) and plasma amino acids.~   "
102872|NCT02220842|"~     This open-label, multicenter, global study is designed to assess the safety, tolerability,~     preliminary efficacy, and pharmacokinetics of intravenous atezolizumab (MPDL3280A) and~     obinutuzumab in participants with refractory or relapsed follicular lymphoma (FL) or~     atezolizumab and obinutuzumab or tazemetostat administered in participants with refractory or~     relapsed diffuse large B-cell lymphoma (DLBCL). The anticipated duration of this study is~     approximately 4.5 years.~   "
102857|NCT02221037|"~     Lung injury in patients undergoing oesophagectomy may occur during surgery (peri-operatively)~     as a result of One Lung Ventilation (OLV) and/or during the immediate post-operative period~     when patients receive intensive care. This is reinforced by the observation that~     physiological markers of lung injury are most elevated immediately after completion of~     surgery, and the development of clinical Acute Respiratory Distress Syndrome (ARDS)occurs~     immediately post-operatively (within 72 hours of surgery), with the majority of cases~     reported 24-48 hours after completion of surgery. This study is designed to investigate the~     impact of pre-operative administration of GSK2862277 on biological and physiological markers~     of lung injury in patients undergoing surgical resection of oesophageal cancer in order to~     achieve optimal exposure at the site of injury following OLV and lung deflation. This study~     is a randomized placebo controlled, double-blind, multi-centre, single dose parallel group,~     design. There will be two treatment groups comprising one active and one placebo arm with~     approximately 40 patients per group. Patients enrolled in the study will be scheduled to~     undergo planned/elective trans-thoracic surgery for oesophagectomy. The primary endpoint for~     this study is the change in pulmonary vascular permeability index (PVPI) from pre-surgical~     levels to the end of surgery. GSK2862277 will be administered as an orally inhaled aerosol~     (single nebulized dose) over approximately 3 to 5 minutes (min) 1-3 hours prior to surgery.~     Subject will be monitored daily until discharge and followed up till day 28.~   "
102858|NCT02221024|"~     Children admitted in a ward often require a peripheral intravenous catheter to provide access~     for administration of medications, nutrients, fluids, blood products. Vascular access in~     children is a frequent and stressful procedure that should be performed as infrequently as~     possible in order to reduce the child's pain experience and the child's and family's level of~     distress. The maintenance of patency of indwelling catheters is therefore relevant to~     minimize need for replacement and children discomfort.~      Recent studies investigated the most effective and safe method of maintaining peripheral~     intravenous lock (peripheral IVL) in children. Most of these studies focused primary on the~     use of heparin versus saline flushes, showing similar efficacy of the two approaches.~      To the best of the investigators knowledge no study addressed the issue of the optimal~     flushing frequency of normal saline . The aim of this study was to evaluate the efficacy of~     normal saline flushes, at 12 and 24 hours intervals.~   "
102859|NCT02221011|"~     The effect of traditional treatment for spasticity is barely satisfactory. The shock wave has~     been used to treat the spasticity with expressively response and the effect could persist for~     1-3 months in different studies. However most sutdies lack the sham or control group. The~     purpose of this study was to assess the effect of shock wave for spasticity in wrist and~     hand.~   "
102860|NCT02220998|"~     The primary objectives of this study are to evaluate the efficacy, safety, and tolerability~     of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks~     compared to treatment with sofosbuvir (SOF) plus ribavirin (RBV) for 12 weeks in participants~     with chronic genotype 2 hepatitis C virus (HCV) infection.~   "
102861|NCT02220985|"~     This phase II trial studies how well selective T cell depletion works in preventing~     graft-versus-host disease (GVHD) in patients with acute lymphocytic leukemia, acute myeloid~     leukemia, or chronic myelogenous leukemia undergoing donor peripheral blood stem cell~     transplant. Giving chemotherapy and total-body irradiation before a donor peripheral blood~     stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's~     immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor~     are infused into the patient they may help the patient's bone marrow make stem cells, red~     blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor~     can make an immune response against the body's normal cells. Removing a subset of the T cells~     from the donor cells before transplant may stop this from happening.~   "
102862|NCT02220972|"~     This will be a multi-center, randomized, double-blind, placebo-controlled, crossover study to~     evaluate the effects of 2007/Fycompa (perampanel) on sleep, in subjects with well controlled~     partial onset seizures (on an antiepileptic drug [AED] monotherapy) who are experiencing~     sleep onset insomnia.~   "
102863|NCT02220959|"~     the purpose of this study is to determine if 60 meter test done prior to surgery is a~     predictive in terms of extubation in morbid obese patients undergoing morbid obese surgery.~   "
102864|NCT02220946|"~     vaginal electrical stimulation improves female sexual dysfunction~   "
102865|NCT02220933|"~     The purpose of this study is to demonstrate the superiority of MD1003 over placebo in the~     disability of patients suffering from progressive multiple sclerosis and especially those~     with gait impairment.~   "
102866|NCT02220920|"~     The purpose of this study is to evaluate the efficacy and safety of Canagliflozin (TA-7284)~     in combination with Insulin in patients with type 2 Diabetes for 16 weeks administration.~   "
102867|NCT02220907|"~     The purpose of this study is to evaluate the safety and efficacy of co-administration of~     Teneligliptin (MP-513) and Canagliflozin (TA-7284) once daily for 52 weeks in Japanese~     patients with Type 2 diabetes mellitus who are receiving treatment with Teneligliptin and~     have inadequate glycemic control.~   "
102868|NCT02220894|"~     In this study, participants with programmed cell death ligand 1 (PD-L1)-positive non-small~     cell lung cancer (NSCLC) will be randomized to receive single agent pembrolizumab for up to~     35 treatments or standard of care (SOC) platinum-based chemotherapy (carboplatin + paclitaxel~     or carboplatin + pemetrexed for 4 to 6 21-day cycles). Participants on the platinum-based~     chemotherapy arms with non-squamous tumor histologies may receive pemetrexed maintenance~     therapy after the 4 to 6 cycles of chemotherapy. The primary study hypothesis is that~     pembrolizumab prolongs overall survival (OS) compared to SOC chemotherapy.~   "
102869|NCT02220881|"~     The primary objective of this study is to investigate the effectiveness of mold making~     silicone toe separator on reducing the hallux valgus angle. In addition, this study aims to~     determine the compliance of mold making silicone toe separator, the change in pain level and,~     including, the satisfaction of the participants after using mold making silicone toe~     separator.~   "
102870|NCT02220868|"~     The protocol will study the safety and efficacy of using sofosbuvir and ribavirin for the~     treatment of hepatitis c in patients taking stribild.~   "
103990|NCT02206217|"~     The purpose of this study is to determine if the Multiple-Segment (MS) lens can slow myopia~     progression in Hong Kong schoolchildren.~   "
102873|NCT02220829|"~     Approximately 50%-95% of prostate cancer patients undergoing radiation therapy (RT) develop~     symptomatic urinary problems .These symptoms can significantly diminish a patient's quality~     of life during and shortly after therapy. Alpha1-blockers, such as Rapaflo, act to decrease~     resistance to urinary flow.~      This multi-institutional phase III trial is designed to compare standard of care versus~     preventive treatment with Rapaflo for prostate cancer patients, regardless of risk group,~     whose treatment consists of radical radiation therapy. We plan to recruit 188 patients across~     Quebec who will be randomized into two arms: rapaflo prescribed at start of radiation therapy~     or if/when symptoms appear.~   "
102874|NCT02220816|"~     Within a prospective, randomised, controlled study 60, selected patients with chronic (> 6~     months) stroke or traumatic brain injury will be randomised to 30 1-hour sessions of~     competitive versus non-competitive attentional training. Competitive training will include~     fifteen 1-hour sessions of standard (paper and pencil) training under competitive situations~     and fifteen 1-hour sessions of competitive attentional games designed for this purpose using~     a new virtual reality system (conventional liquid-crystal-display screen with an infrared LED~     array to facilitate multi-touch experience embedded in a conventional table). Progress will~     be evaluated by pre and post measurement of attentional neuropsychological tests, subjective~     reports of global attention, usability and motivational scales. Our hypothesis is that~     competitive training is more effective in improving attention than conventional training in~     the chronic phase after acquired brain injury.~   "
102875|NCT02220803|"~     This is a short term open, randomized cross over trial to explore and compare the efficacy of~     pharmacological carbonic anhydrase (CA) inhibition on obstructive sleep apnea (OSA) related~     hypertension. Patients will be randomized to receive Acetazolamide(Diamox®)(ACZ), Continuous~     Positive Airway Pressure (CPAP)or CPAP plus ACZ for 2 weeks. Following a 2 week wash-out~     period all study participants will receive the alternative treatment regimen. The total~     length of the study will be 10 weeks. The effects of carbonic anhydrase inhibition on blood~     pressure,hemodynamics and sleep apnea will be investigated.~      Study hypothesis:~      Carbonic anhydrase inhibition alone or in combination with nCPAP will prominently reduce~     blood pressure in patients with OSA. Further it is hypothesized that CA inhibition will~     induce a direct pharmacological effects on vascular stiffness as evidenced in overnight~     non-invasive assessments of vascular stiffness and that this effect will be particularly~     strong in patients also responding with a reduction of blood pressure.~   "
102876|NCT02220790|"~     The purpose of the study is to 1) define the operating characteristics of fungal biomarker~     assays in pediatric patients at high-risk for developing invasive candidiasis, 2) determine~     the change in fungal biomarker assay results in children who develop invasive candidiasis,~     and 3) create a biobank of blood samples from pediatric patients at high-risk for invasive~     candidiasis and those with invasive candidiasis for future testing of fungal biomarker assays~     and development of new fungal biomarker assays. The study will assemble a prospective cohort~     of pediatric patients at high-risk for developing invasive candidiasis. Blood samples for~     biomarker testing will be obtained at the time a patient has a clinical indication for blood~     culture attainment. Additional blood sampling will be performed on the sub-set of patients~     that are found to have invasive candidiasis. The sensitivity, specificity, PPV, and NPV of~     biomarker assays will be determined for each biomarker assay. No PHI will be stored in the~     database and limits on blood draws (3 ml/kg in an 8 week period) will be adhered to.~   "
102877|NCT02220777|"~     This is a 4-part study. Part I assesses the safety and tolerability of single ascending doses~     of ASP8477 or a placebo under fasted conditions in postmenopausal subjects. Part II is~     similar to part I except that the study is conducted in young, vasectomized males.~      Part III assesses the effect of food (fed or fasted conditions) on ASP8477 in postmenopausal~     subjects.~      Part IV assesses the drug-drug interaction between ASP8477 and omeprazole in postmenopausal~     subjects.~   "
102878|NCT02220764|"~     The objective of this prospective clinical study is to investigate the differences in the~     complication rates between tooth- and implant- supported zirconia based fixed dental~     prostheses (FDPs) with at least 4 units. The null-hypothesis is that there is no difference~     in the complication rates between implant- supported and tooth- supported zirconia FDPs.~   "
102879|NCT02220751|"~     The purpose of the study was to monitor the activity of periodontal disease and suggest~     potential biomarkers related to active periodontal disease in patients with chronic~     periodontitis (PD) associated or not with type 2 diabetes mellitus (DM), based on the~     evaluation of the profile of gene expression of periodontal sites and the evaluation of~     inflammatory salivary proteins. Two hundred and five periodontal patients were enrolled, but~     only 41 exhibited ≥ 1 mm attachment loss in at least three periodontal site (active sites) 2~     months after non-surgical periodontal therapy. The final sample was: 21 patients with chronic~     periodontitis (PD group) and 20 with chronic periodontitis and diabetes (PD+DM group).~     Fifteen periodontal- and systemically healthy patients were included as control group. Saliva~     collection, glycated hemoglobin measurement, periodontal examination and radiographs were~     conducted before and 2 months after non-surgical periodontal therapy. Radiographic~     subtraction was performed from pairs of the radiographs. Measurements of the areas with~     density loss were recorded. Gingival biopsies of active and non-active sites with similar~     clinical parameters were harvested for Real Time Polymerase Chain Reaction Array gene~     expression analysis. Saliva samples were analyzed by Multiplex Cytokine Profiling Immunoassay~     for analysis of protein expression. The clinical attachment loss mean was higher in the PD+DM~     group (p<0.05). There was a high correlation between clinical attachment loss and darkened~     radiographic areas in active sites of the PD group and PD+DM group. When compared PD group to~     PD+DM, patients with diabetes had an up-regulated profile. Active sites of the PD group~     showed nine genes (specific chemokines, interleukins and receptors) differentially expressed~     with an up-regulated profile. Active sites of the PD+DM group showed six genes (specific~     chemokines, interleukins and receptors) differentially expressed with an up-regulated~     profile. After periodontal therapy, there was a reduction of some salivary proteins in both~     periodontal groups, but not significant. In conclusion, it was possible to identify genes~     differentially expressed in active sites from both groups, which may be considered useful in~     indicating potential biomarkers for the diagnosis of periodontitis; salivary proteins show a~     trend in distinguishing the standard of health and disease and may be used in the future as~     potential biomarkers of periodontitis with or without diabetes.~   "
102880|NCT02220738|"~     This study is designed to evaluate the safety, tolerability and pharmacokinetics of multiple~     doses of ABT-957 in subjects with mild to moderate Alzheimer's disease.~   "
102881|NCT02220725|"~     The purpose of this study is to evaluate the ability of Andexanet Alfa to reverse the~     anticoagulation effect of Rivaroxaban.~   "
102882|NCT02220712|"~     To assess the pharmacokinetics and safety of aripiprazole intra-muscular (IM) depot~     formulation in patients with schizophrenia after repeated administration by injection into~     the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals~   "
102883|NCT02220699|"~     All Danish general practices have a data capture system that collects selected data from the~     electronic patient record. These data are used for various quality assurance purposes. The~     aim of the study is to evaluate the quality assurance system/program that identifies patients~     having an increased risk of osteoporosis.~   "
102884|NCT02220686|"~     The purpose of the study is to see if vascular physicians (your provider) using a combination~     of proven smoking cessation tools in an organized way can help vascular patients quit smoking~     better than usual.~      The doctors where you are being treated have been chosen to either provide:~      the combination therapy of giving you advice, considering prescribing medications to help you~     quit smoking, and referring you to a phone quitline, or to continue their usual smoking~     cessation practices (which may include all, some, or none of the treatments above).~   "
102885|NCT02220673|"~     Primary objective: To investigate the safety and local tolerability of increasing cumulative~     doses (2, 4, 6 actuations) of a low (0.1%) and a high (0.5%) concentration of BHT~     administered via oral inhalation with the Respimat® inhaler B (RMT-B) vs. 2 inhalation~     solutions without BHT (placebo to BHT given by RMT B and placebo given by hydroxylfluoralkane~     metered dose inhaler (HFA MDI)). In a first step, the trial was performed in healthy subjects~     and - if no safety concerns arose - in a second step in patients with mild asthma who were~     sensitive to metacholine in a respective challenge test. Secondary objective: To explore the~     pharmacokinetics (PK) of BHT.~   "
102886|NCT02220660|"~     The primary objective of this study was to compare the systemic exposure of BI 1744 BS and CD~     1857 XX (the active metabolite of the pro-drug BI 54903 XX) at steady state following~     inhalation of the fixed dose combination (FDC) BI 1744 CL plus BI 54903 XX (as ethanolic~     solution for inhalation, EIS) with the systemic exposure following inhalation of the free~     dose combination of BI 1744 CL (as aqueous solution for inhalation, AIS) and BI 54903 XX~     (EIS), respectively, when administered once-daily via Respimat® Inhaler (Respimat® A for AIS~     and Respimat® B for EIS) for 14 days in healthy volunteers. Secondary objectives were: to~     compare exposure to BI 1744 BS and CD 1857 XX after a single dose of the BI 1744 CL/BI 54903~     XX FDC and the free dose combination, respectively; to compare exposure to BI 54903 XX after~     a single dose and at steady state after multiple doses of the BI 1744 CL/BI 54903 XX fixed~     dose combination and the free dose combination, respectively; to compare the safety and~     tolerability of BI 1744 CL and BI 54903 XX when administered as BI 1744 CL/BI 54903 XX fixed~     dose combination and as the free dose combination, respectively.~   "
102887|NCT02220647|"~     Study to assess bioequivalence of a 2.5 mg linagliptin / 850 mg metformin fixed dose~     combination (FDC) tablet compared to single tablets of linagliptin 2.5 mg and metformin 850~     mg administered together~   "
102888|NCT02220634|"~     The purpose of this study is to see if Regadenoson may offer improved ease of use, single~     dose administration, and better tolerance for testing for pulmonary hypertension than iNO.~     You will be screened to make sure Regadenoson is safe for you with a clinical evaluation,~     blood tests, and an ECG.~   "
102889|NCT02220621|"~     Intrauterine adhesion (IUA) is the adhesion of intrauterine tissues due to the exposure of~     myometrial tissues caused by the endometrial basal injury. IUA is clinically manifested as~     symptoms such as abdominal pain, hypomenorrhea or amenorrhea, sterility and habitual~     abortion, which seriously affect the patients quality of life.~      Preventing IUA has been tried using different methods such as barrier or stent in order to~     separate the opposing endometrium during the tissue healing processes. Although some~     successes have been reported there are still some challenges need to be dealt with.~      One of the barrier materials for preventing IUA is made of hyaluronic acid (HA). HA is a~     natural ECM of human tissue with excellent biocompatibility and promotes the scar-free wound~     repair. The self-crosslinked esterified HA gel has demonstrated the capacity to prevent IUA~     in clinical studies.~      A novel self-crosslinked HA gel is developed by BioRegen Biomedical（Changzhou）Co., Ltd with~     proprietary technologies. This product is a highly viscoelastic crosslinked gel that~     overcomes the shortcoming of sodium hyaluronate with high motility and too quick degradation~     in vivo. For this product, the results of animal experiments and various safety features have~     been designed and tested conforming to the national regulations and standards. In order to~     launch this product to the market, this prospective, randomized and controlled clinical trial~     is designed and will be performed to verify its safety/efficacy.~   "
102890|NCT02220608|"~     The purpose of this research study is to determine the highest dose of a drug called~     bortezomib that can be given with a drug called G-CSF before stem cell collection to help in~     the mobilization of stem cells.~   "
102891|NCT02220595|"~     This study compares cognitive function after carotid endarterectomy and stenting.~   "
102892|NCT02220582|"~     The Cardiac, Vascular and Cognitive Dysfunction (CVCD) Alliance will be a prospective,~     multi-ethnic cohort study in healthy Canadian individuals between 35 and 69, looking at~     contextual risk factors and novel predictors of hard events over a period of four years.~      The unique features of this initiative are:~        -  MRI as the sole imaging technique (including the use of a mobile MRI machine)~        -  Contextual factor analysis (including community environmental profile assessments)~        -  Record linkage follow-up of individuals to health services (administrative) databases~          for major morbidity and mortality events and health services utilization~   "
102893|NCT02220569|"~     PULSE-ECCho will focus on trying to detect cardiotoxicity in cancer patients receiving~     chemotherapy early on in order to avoid irreversible damage. In addition to that, we will~     test if the PhysioFlow is non-inferior to the conventional MUGA scan.~   "
102894|NCT02220556|"~     Fifteen cohorts will be opened. Each cohort will explore one analysis method and/or tumoral~     type. Up to 50 patient can be included into each cohort.~   "
102895|NCT02220543|"~     The aim of this study is to evaluate the effectiveness and cost-effectiveness of a new~     primary care intervention Back on Track as compared to usual primary care in patients with~     non-specific chronic low back pain in which disability levels are moderate and the role of~     psychosocial factors to this disability is at maximum low (classified as WPN2).~   "
102896|NCT02220530|"~     This study aims to assess the impact of the use of sedation on the overall quality of the~     colonoscopy, therefore addressing each and every one of its dimensions, namely: scientific~     and technical quality, perceived quality and safety.~   "
102897|NCT02220517|"~     The hypothesis of the study is that targeted MRI/US fusion-guided prostate biopsy with~     additional systematic transrectal ultrasound (TRUS)-guided biopsy significantly detects more~     prostate cancers than targeted MR-guided in-bore prostate.~   "
102898|NCT02220504|"~     This open-label, non-randomized, prospective study will evaluate the risk of symptoms~     recurrence during the three years after antipsychotic discontinuation in a sample of~     functionally recovered first-episode patients with schizophrenia spectrum disorder.~   "
102899|NCT02220491|"~     Patients with brain metastases with expected life expectancy of 3-6 months are typically~     treated with radiotherapy to the whole brain giving a dose of 20 Gy over a 5 day period. This~     study will compare this with volumetric modulated arc therapy (VMAT) which is capable of~     delivering 15 Gy in one single session to identified disease within the brain but sparing the~     normal surrounding brain tissue. Primarily the study will assess whether it is possible to~     recruit sufficient patient numbers to a trial of this type. It will also compare~     effectiveness, side effects and quality of life between the two treatment methods.~   "
102900|NCT02220478|"~     The primary purpose of this pilot study is to evaluate the accuracy of cup placement between~     two instrumentation technologies: Cutting Guide and Conventional Instrumentation.~   "
102901|NCT02220465|"~     The study's primary aim is to test the hypothesis that an intervention that integrates low to~     moderate physical activity (walking) with evidence-based smoking cessation counseling (LMPA)~     will result is greater reductions in quit-day reactivity to smoking cues (a behavioral~     predictor of smoking relapse) as compared to standard care smoking cessation counseling~     (control group) in a sample of low-income sedentary male and female smokers. The study will~     also test the hypothesis that the participants randomized to the LMPA intervention will have~     greater quit rates at one-week and one-month post quit day follow ups.~   "
102902|NCT02220452|"~     -  The perioperative period can be a significant source of psychological burden, anxiety~          and fear for patients~        -  Both pharmacological and non-pharmacological methods have been proposed in order to~          alleviate perioperative stress~        -  Music is one of the non-pharmacological methods which have been used in this context,~          with favorable effects both preoperatively and postoperatively~        -  The attenuation of perioperative stress through music listening is probably due to the~          activation of emotional and cognitive processes that evoke feeling of pleasure and can~          distract patients' attention from fear and unpleasant thoughts related to the surgical~          procedure~        -  Little information is available regarding the effect of intraoperative music listening~          on anesthetized, unconscious patients~        -  There is a notion that general anesthesia does not completely abolish auditory~          perception and that some processing of intraoperative events can occur in unconscious~          patients, even in the absence of postoperative recall~        -  The investigators hypothesis is that intraoperative music listening can decrease~          anesthetic requirements and reduce sevoflurane consumption in female patients subjected~          to abdominal hysterectomy for benign disease.~   "
102903|NCT02220439|"~     This is a proposal for a nested case‐control study within an ongoing rotavirus vaccine~     immunogenicity clinical trial Karachi, Pakistan. The primary study aim is to compare the~     fecal microbiota composition and diversity of infants who do (control) and do not (case)~     demonstrate immune seroconversion to rotavirus vaccination. The infants will be matched for~     vaccination dose, age and breast‐feeding practices.~   "
102904|NCT02220426|"~     The primary goal of this study is to evaluate the feasibility of detecting Brown Adipose~     Tissue (BAT) in healthy subjects by using hyperpolarized xenon gas MRI.~      In this pilot study, MRI of BAT of healthy adult volunteers will be performed at 3 Tesla to~     assess image quality using a prototype surface coil and pulse sequence following inhalation~     of hyperpolarized 129Xe (xenon) gas at thermoneutrality and under mild cold condition.~      The investigators are testing the abilities of xenon MRI to see brown adipose tissue and~     detect its thermogenic activity.~   "
102905|NCT02220413|"~     The purpose of this study is to investigate what proportion of obese women will have a~     self-reported delay in lactogenesis II (breastmilk coming in) compared to women with a~     normal weight. We hypothesize that obese women will have an absolute 20% increase in delayed~     lactogenesis II.~      We will compare two group of women for delayed lactogenesis II, one group with obese women~     (BMI>30) and one group of women with a normal weight (BMI<30).~      The secondary objective is to assess what other factors influence the self-reported delayed~     lactogenesis II.~   "
102906|NCT02220400|"~     Previous study demonstrated that neuroinflammation induced by surgery is the main cause of~     the postoperative cognitive dysfunction. As an agonist of NMDA receptor, ketamine is proved~     to be an anti-inflammation agent. In present study investigators hypothesized that low dose~     ketamine would prevent the cognition decline after orthopedic surgery in aged patients.~   "
102907|NCT02220387|"~     The objective of this study is to investigate molecular, cytological and genetic features of~     occupational chronic obstructive pulmonary disease (COPD) in conditions of different~     occupational exposures. In order to achieve this goal serum pro-inflammatory cytokines and~     standard inflammation markers level, hemostasis, cytological analysis of bronchoalveolar~     lavage and associations of single nucleotide polymorphisms (SNPs) rs1800470 transforming~     growing factor β1 (TGF β1) gene, rs1828591 hedgehog interacting protein (HHIP) gene,~     rs4129267 interleukin 6 receptor (IL-6R) gene, rs1051730 nicotinic acetylcholine receptor 3~     (CHRNA3) gene with COPD in subjects exposed to silica dust and in those exposed to polycyclic~     aromatic hydrocarbons exhaust will be investigated. The relationship between genotype and~     phenotype characteristics, such as an inflammation activity, assessed by C-reactive protein~     (hsCRP) and tumor necrosis factor-α (TNF α) serum concentration, in different occupational~     COPD groups will be studied. The hypothesis is that the mechanisms underlying disease~     development and progression are different due to environmental risk factor that reflex in~     differs in disease attributes - molecular biomarkers, cytology results and genetic~     susceptibility between COPD due to dust, COPD due to chemicals and COPD in smokers therefore~     COPD can be subdivided into ecological phenotypes according to environmental risk factor.~   "
102908|NCT02220374|"~     Oesteoarthritis of the joints of the finger(s) is a common problem. The first-line treatment~     involves pain killers taken either as tablets, gels, or patches. Secondly, some joints are~     amenable to injections of steroids and anaesthetic agents. Finally, as a last resort, some~     joints may be fused or replaced with prosthetic joints by Hand Surgeons. We are investigating~     whether supportive taping of the painful finger joint reduces pain and improves function, and~     whether this treatment could be used to substitute pain killers, injections or surgery. We~     hypothesise that supportive finger tape may improve pain, improve the stability of the joint~     and thereby improve day-to-day hand function too. We will investigate this through a~     two-group parallel randomised controlled trial whereby one group will receive the treatment~     taping and the other group will receive a theoretically placebo taping configuration. We will~     measure pain daily, hand function and adverse events.~   "
102913|NCT02220309|"~     This research study is aimed at understanding behaviors and brain circuits that relate to~     anxiety and depression. Our goal is to learn which circuits of the brain are involved in~     anxiety and how these circuits might affect daily functioning.~      This study has recently added an additional treatment component: participants undergo a 12~     week course of either Pramipexole medication or rTMS therapy (explained below). The ultimate~     goal of the study is to offer participants experiencing anxiety and depression a treatment~     that is alternative to ones that have failed them in the past, and to apply the knowledge we~     gain from investigating the brain circuits involved in anxiety and depression to help~     personalize treatments.~      We invite anyone who has recently experienced any symptoms of anxiety and/or depression to~     participate (no diagnosis is required to participate).~   "
102914|NCT02220296|"~     This trial is conducted in Europe. The purpose is to evaluate safety and tolerability of a~     range of single doses of subcutaneous insulin 338.~   "
102915|NCT02220283|"~     Compare the renal complication of endovascular and open repair of acute aortic dissection by~     including patient treated at NTUH in 2010~2013.~   "
102916|NCT02220270|"~     The purpose of this study is to determine the safety, performance and efficacy of the~     Hyperion™ Occluder Systems during treatment of ASD and PDA patients.~   "
102917|NCT02220257|"~     Natural course of diabetes mellitus involves gradual reduction of β cell mass within islets~     of Langerhans in the pancreas. Symptoms of diabetes present when the mass of~     insulin-producing cells reaches a point where insulin concentration does not suffice to~     maintain proper glycaemia. In many patients β cells regenerate shortly after the diagnosis of~     diabetes and initiation of insulin therapy. This phenomenon is called a remission.~      The aim of this study is to asses the influence of occurrence and duration of remission on~     development of chronic complications of diabetes and patients outcome.~   "
102918|NCT02220244|"~     The purpose of this study is to demonstrate the superiority of MD1003 over placebo in the~     visual improvement of patients suffering from chronic visual loss resulting from multiple~     sclerosis related optic neuritis.~   "
102919|NCT02220231|"~     Video-assisted thoracoscopic extended thymectomy (VATET) is a minimally-invasive method for~     excision of mediastinal mass instead of open thymectomy. The iatrogenic capnothorax with~     one-lung ventilation during VATET may cause hemodynamic instability due to the compression of~     intrathoracic structures. The purpose of this study is to evaluate the effects of capnothorax~     on the pulmonary blood flow and cardiac function during the VATET by using the~     transesophageal echocardiography.~   "
102920|NCT02220218|"~     The purpose of this study to evaluate the bioequivalence (is the amount same in both the~     pills) of metformin component of the canagliflozin and metformin immediate release (IR) fixed~     dose combination (FDC) tablet compared with the metformin IR tablet co-administered with~     canagliflozin tablet in healthy fed and fasted participants.~   "
102921|NCT02220205|"~     Intrauterine devices (IUDs) are a very effective, long-acting method of contraception. In~     order to make them accessible to women, health care providers must be trained to insert them.~     Physicians, physician assistant, and nurse practitioners often learn how to do so by first~     learning about IUDs, then practicing on a model that the IUD manufacturer provides.~      Educators have recently been using more sophisticated models to teach clinical skills such as~     surgical procedures. We are investigating whether these models may be more useful in teaching~     IUD insertion.~   "
102922|NCT02220192|"~     This is a pilot study to test the short-term effectiveness of an alternative treatment~     approach for precancerous cells of the cervix. The study will also explore whether this new~     treatment is feasible to perform and if it is acceptable to patients.~   "
102923|NCT02220179|"~     In this project we invite 9.000 children and young persons in Denmark and their foster~     parents and staff at the residential institutions to participate in a cluster randomized~     controlled intervention study where we aim to test the effectiveness of a web based knowledge~     and inspiration program about resilience for children, adolescents and adults (called~     myresilience.org). The complete CONSORT trial protocol is available at~     http://myresilience.org/ at the subsite 'about us'.~   "
102924|NCT02220166|"~     Preliminary studies on safety profile of Triticum Monococcum (Tm, a variety of Ancient Wheat)~     have provided conflicting results with some in vitro and ex vivo studies consistent with non~     toxicity and other suggestive of toxicity. We recently reported results of a single~     administration of 2.5 grams of Tm in 12 Celiacs in remission on Gluten Free Diet (GFD), while~     assessing symptoms and changes of intestinal permeability. Although results of intestinal~     permeability were inconclusive Tm, but not other type of gluten, was clinically well~     tolerated.~      The aim of the present study was to assess safety of 60 days of administration of Tm (100~     grams of water biscuits per day accounting for about 6 grams of gluten from Tm) as judged on~     clinical, serological and histological parameters in Celiac Disease patients on remission~     after 1 year of GFD.~   "
102925|NCT02220153|"~     This study is designed to evaluate the safety and tolerability of single ascending doses of~     UCB7665 administered by intravenous or subcutaneous infusion in healthy subjects.~   "
102926|NCT02220140|"~     In this project we invite 8.000 young persons (age 18-27) in Denmark and to participate in a~     randomized controlled intervention study where we aim to test the effectiveness of a web~     based knowledge and inspiration program about resilience for children, adolescents and adults~     (called myresilience.org). The complete CONSORT trial protocol is available at~     http://myresilience.org/ at the subsite 'about us'.~   "
102934|NCT02220036|"~     This is a double-blind randomized clinical trial which will start at June 2014 and end on~     June 2015 in Isfahan city. Serum creatinine level is considered as a key variable and the~     sample size calculated 80 persons (40 persons for control group and 40 persons for patient~     group). Patients aged more than 18 years old with diabetic nephropathy having Fasting Blood~     Sugar more than 126 mg/dL and proteinuria 30-300 mg/dL (microalbuminuria) and Glomerular~     Filtration Rate more than 90 mL/min will be chosen. Patient group will receive magnesium~     supplement (250 milligram) and the other group will receive placebo which is similar to the~     magnesium tablets in color, odor and appearance both for 12 weeks. All subjects will complete~     4 physical activity and 4 dietary records. Outcome measurements including metabolic, renal~     and inflammatory profiles will be measured at the beginning and end of the study as well as~     anthropometric measurements.~   "
122545|NCT01963455|"~     This study was designed to provide confirmation of safety of muscle derived cell (MDCs) for~     the treatment of stress urine incontinency (SUI) in women.~   "
102927|NCT02220127|"~     Gamma Knife Radiosurgery (GKR) is a well-established treatment modality for brain metastasis~     (Chiou 2013; Salvetti, Nagaraja et al. 2013). Large multicentre series have been published on~     patients with single and multiple cerebral metastases, treated with GKR over a period of 30~     years (Karlsson, Hanssens et al. 2009). Multiple institutions have reported a consistently~     high local tumour control rate of 80%-90% following GKR (Chang, Lee et al. 2000; Da Silva,~     Nagayama et al. 2009; Salvetti, Nagaraja et al. 2013).~      There is controversy over the use of GKR and/or Whole Brain Radiotherapy (WBRT) in patients~     with multiple metastases. WBRT provides a lower rate of distant recurrences, whereas GKR~     achieves good local control of treated lesions without the deleterious side effects of~     radiotherapy (Lippitz, Lindquist et al. 2014). This discussion is mainly focused on the risk~     of distant recurrences, which is lower if WBRT is given. There is evidence showing that~     Radiosurgery (RS) based on high contrast/resolution stereotactic MRI decreases the incidence~     and lengthens the time to distant recurrences (Hanssens, Karlsson et al. 2011). As a result,~     the current tendency is to treat all the lesions visible in high contrast/resolution images~     the day of Gamma Knife; which is followed by regular MRI follow ups and subsequent GKR for~     distant recurrences in order to avoid/delay WBRT.~      It has been estimated that more than a half of distant recurrences will grow from tumour~     cells that were already in the brain (as micrometastases) when radiosurgery is delivered, but~     not much has been studied on the optimal prescription and radiation delivery method for these~     lesions. There is controversy over which collimator should be used when treating~     micro-metastases (BmM). These lesions can either be treated with the 4mm collimator at an~     isodose between the 40% and 90%, or the 8mm collimator at an isodose above 90%. The 8 mm~     collimator is thought to offer better Local Control Rate (LCR) with the advantage of faster~     delivered treatments, while the 4 mm collimator is considered to be safer, given its steep~     dose fall-off. It is the aim of this study to find out which of the 4 mm or 8 mm collimators~     can achieve the higher LCR with less complications. A large number of lesions will be~     randomised to either the 4 or the 8 mm collimator and the patients followed up to evaluate~     clinical efficacy.~   "
102928|NCT02220114|"~     The sponsor is developing a new paediatric formulation of vigabatrin to better adjust the~     dose to body weight and to limit waste of unused drug. The currently marketed vigabatrin~     (Sabril™) form only exists as 500 mg film coated tablets (for adults and children above 6~     years) and 500 mg granules for oral solution sachets (for infants and children below 6~     years). Sabril™ is not adapted for administration to infants when a fraction of the sachet is~     needed. Manual splitting of the sachet or lengthy and error-prone dilutions are often~     required.~      This study is a descriptive, non-randomized, open label multi-centric acceptability study in~     infants and children affected with infantile spasms. The primary objective is to describe the~     adherence to the new formulation. Secondary objectives include:~        -  evaluation of the palatability and user-friendliness of the new treatment,~        -  evaluation of the pharmacokinetic parameters of the new formulation,~        -  PK parameters,~        -  evaluation of the tolerance,~        -  measurement of taurine plasma levels. This study will recruit up to 40 patients with~          infantile spasms and pharmacoresistant partial epilepsy aged 1 month to 6 years in 23~          clinical sites in France.~   "
102929|NCT02220101|"~     Comparison of four methods for measuring temperature perioperatively in patients scheduled~     for laparoscopic surgery and intensive care patients who are hypo-, normo-and hyper terme;~     Bladder Monitoring, Nasopharyngeal, SpotOn TM, Zero heat flux method and Temporal Scanner.~     The study is a single-center, observational study carried out by the Central Surgical and~     Intensive Section at Vestfold Hospital Trust.~   "
102930|NCT02220088|"~     Transarterial chemoembolization (TACE) is considered the gold standard for treating~     intermediate-stage hepatocellular carcinoma (HCC). However, any treatment guidelines do not~     specify the criteria for repeating TACE.The study,conducted in Europe ，recently published in~     the journal of Hepatology shows the ART score of >=2.5 prior the second TACE identifies~     patients with a dismal prognosis who may not profit from further TACE sessions. However,in~     clinical practice，we also found some patients who showed TACE-resistant at the beginning of~     treatment may access to get objective response of retreatment with TACE.So the investigators~     conduct this prospective,randomized controlled study to find out whether the patient who~     showed TACE-resistant can obtain survival benefit from retreatment with TACE.~   "
102931|NCT02220075|"~     LMA(Laryngel Mask Airway) is useful for pediatrics surgery, and there are various methods of~     LMA insertion. When the investigators evaluate the LMA position, the investigators can use~     fiberoptic bronchoscope (Grade 1 to 4). For pediatric patients, clinical signs(airway~     pressure<20cmH2O, expiratory CO2 level)are seen normal but the grade is 3 or 4. And this will~     bring high risk of aspiration. Recent studies reported the LMA position after general~     anesthesia induction not after operation. Therefore, the investigators will observe the LMA~     position three times; after general anesthesia induction, after caudal block, and after~     operation as well as the difference regarding to spontaneous and controlled ventilation.~   "
102932|NCT02220062|"~     Pancreatic cancer related pain can be difficult to control, even with high doses of~     narcotics, whose adverse effects may further impair quality of life. So EUS-CPN(endoscopic~     ultrasound guided celiac plexus neurolysis) is well established as an effective technique for~     controlling pain and reducing narcotic requirements in patients with pancreatic cancer.~     Recently, celiac ganglia can be visualized and accessed by endoscopic ultrasound. So it~     allows for direct injection into individual celiac ganglia to perform celiac ganglia~     neurolysis. This more precise delivery of therapeutic drug will offers the potential for~     enhanced efficacy and safety. To evaluate this hypothesis, this randomized controlled trial~     aimed to compare the efficacy and safety of EUS-CGN(Endoscopic ultrasound guided celiac~     ganglia neurolysis) vs. Bilateral EUS-CPN(Endoscopic ultrasound guided celiac plexus~     neurolysis) in providing relief from pancreas cancer-related pain.~   "
102933|NCT02220049|"~     VELCADE has demonstrated marked activity in haematological cancers leading to registration~     (MM, MCL).~      Currently only biweekly or weekly regimens have been explored. Key signalling pathways which~     are aberrant in haematological cancers are also present in solid tumors.~      VELCADE covers a broad spectrum of proteins, which are pivotal in carcinogenesis.VELCADE as a~     single agent & in combination with chemotherapy in solid cancers has shown modest and real~     anti-tumor activity but insufficient for Phase III development.~      VELCADE PK exposure may be inadequate in solid tumors compared to liquid cancers. VELCADE~     daily low dose administration may allow a greater PK exposure to be achieved, which is~     tolerated~      Hypotheses:~      VELCADE daily dosing (5-days on, 2-days off) is tolerable at biologically active doses~     VELCADE daily dosing (5-days on, 2-days off) results in increased PK (AUC)/PD (20S proteasome~     inhibition) VELCADE daily dosing (5-days on, 2-days off) with increased PK/PD results in~     improved anti-tumor activity (Increased tolerable VELCADE AUC may potentially cross the~     threshold required for clinically significant anti-tumor activity in solid cancers).~      Some preclinical data suggest that: VELCADE daily dosing results in increased proteasome~     inhibition in tumor tissues Combination of VELCADE + XRT/other daily dosing agent may have~     increased anti-tumor activity compared to monotherapy alone.~   "
102935|NCT02220023|"~     The purpose of the study is to measure RV ejection fraction (RVEF), pulmonary flow, and~     pulmonary perfusion before and after exposure to inhaled nitric oxide in patients with~     pulmonary arterial hypertension (PAH) who are known to be vasodilator-responsive based on~     invasive catheterization as well as healthy subjects. Measurements will also be made after~     high flow oxygen alone to test the relative vasodilatory effect of oxygen and NO. The~     investigators hypothesize is that inhaled nitric oxide during cardiac MRI can be used to~     measure dynamic changes in RV-pulmonary vascular function in patients with~     vasodilator-responsive PAH.~   "
102936|NCT02220010|"~     Dividing pancreas when performing left-sided resections opens the risk for leakage from the~     divided end of the pancreas. Pancreatic juices could have a severe effect on surrounding~     abdominal tissues with abscess formation producing systemic inflammation and potential lethal~     bleeding. Proper drainage of pancreatic juices is the primary treatment. Effective drainage~     reduces healing time. A pancreatic stent could theoretically improve the drainage of~     pancreatic juice into the duodenum and by this shorten the healing time still further.~      Pre operative prophylactic stenting of the pancreas before division of the parenchyma has not~     shown a positive effect on fistula formation.~      In an open randomized multicenter clinical trial we want to test the hypothesis that a~     reduced fistula healing time, in left sided pancreatic resections, could be reduced by~     introducing a pancreatic stent when on post operative day 3 or later a B och C fistula~     (according to the International Study Group on Pancreatic Fistula, ISGPF) is diagnosed by~     randomizing between pancreatic stent with drains versus only drains.~   "
102937|NCT02219997|"~     The purpose of this study is to compare the reaction time (as measured by braking reaction~     time in seconds during simulated driving) under glare and no-glare conditions in subjects~     implanted with ACRYSOF® IQ intraocular lenses (IOLs) to subjects implanted with clear IOLs.~     This study will enroll subjects previously implanted with IOLs in both eyes for at least 3~     months.~   "
102938|NCT02219984|"~     This is a phase 4 cohort prospective, open, national, multicentre study that collects data on~     history of patients treated chronically with anticoagulant drugs, including the novel direct~     oral anticoagulants (DOACs). The Registry is designed solely for observational purposes and~     is not intended to have any influence on the treatment of the single patients included.~      Patients are included when they start the anticoagulant treatment, whatever the drug used, or~     when they shift from a vitamin K antagonist (VKA) drug to one of the novel direct oral~     anticoagulants, provided that the therapy is expected to last at least 3 months.~      The general aims of the study are to provide a better evaluation of efficacy and safety of~     different treatment options, and to improve our understanding of the risks/benefits of the~     various anticoagulant drugs and the different therapy options.~      The Registry is open to the participation of clinical centres or individual professionals~     (now called Participants) that are involved with management of anticoagulated patients.~   "
102939|NCT02219971|"~     The purpose of this study is to assess safety, tolerance and pharmacokinetics of a single~     intravenous injection Kukoamine B Mesilate in health volunteer~   "
102940|NCT02219958|"~     Hypertension (HT) is one of the major cause of morbidity and among the top 10 causes of~     deaths in Hong Kong in 2008 (Department of Health 2009). The Hospital Authority (HA) has~     initiated service improvement through introducing the risk assessment and management~     programme (RAMP) to improve the quality of care (QOC) for HT patients in general outpatient~     clinics (GOPC). The evaluation on the QOC is an essential part of the programme in order to~     inform future policy. The Department of Family Medicine and Primary Care (FMPC) of the~     University of Hong Kong (HKU) has been appointed by the HA to carry out the evaluation of the~     QOC of the programme.~      The Action Learning and Audit Spiral methodologies to measure whether the target standard of~     care intended by the RAMP programme is achieved. Each RAMP participating clinic and hospital~     will be invited to complete a structured evaluation questionnaire. The data of all patients~     who have enrolled into the RAMP for more than one year will be included in the evaluation on~     the process and outcomes of care.~      One thousand two hundred and forty-eight age and disease matched control patients who have~     not been enrolled into the RAMP programme will be selected for the comparison in the outcomes~     of care. A hundred and thirty participants will be followed up by telephone to evaluate the~     effect of the programme in quality of life (QOL), patient enablement, and global rating of~     change in health condition at baseline and 6 months after enrolment. Data on the process of~     care will be retrieved from the HA medical records.~      Main Outcome Measures: The primary outcomes are the proportion of participants who have~     received the criterion process of care, and achieved the target blood pressure levels.~      Data Analysis: Descriptive statistics on proportions of centers or subjects meeting the QOC~     criteria will be calculated. The changes in the clinical and patient reported outcomes of~     RAMP subjects will be compared at 12, 24, 36 and 48 months will be compared by paired sample~     t-test. The clinical outcomes between RAMP subjects and control group will be compared by~     independent sample t-test or Chi-square test.~      Results: The QOC of the RAMP programme will be determined. Areas of deficiency and possible~     areas for quality enhancement will be identified.~      Conclusion: The results of this study will provide empirical evidence on whether the HA's~     RAMP programme can achieve improvement in QOC for HT patients. The information will be used~     to guide service planning and policy decision making.~   "
102941|NCT02219945|"~     Electronic noses detecting patterns of volatile molecules have recently been introduced for~     different diagnostic purposes. The diagnostic accuracy of a prototype e-nose device (Bruins~     et al (2013) in Bangladesh showed sensitivity of 76.5-95.9% and specificity of 85.3-98.5%.~     Here the investigators test a production type point-of-care hand-held device with less~     detectors. The investigators explore factors such as food intake, smoking, and co-morbidity,~     as well as the impact of TB treatment, and address the question whether the device could help~     monitor disease and response to treatment.~   "
102942|NCT02219932|"~     The primary objective is to determine whether prolonged-release fampridine (10 mg twice~     daily) has a clinically meaningful effect on participant-reported walking ability over a~     24-week study period.~      The secondary objectives are: to determine whether prolonged-release fampridine 10 mg taken~     twice daily (BID) has a clinically meaningful effect on dynamic and static balance, physical~     impact of multiple sclerosis (MS), and upper extremity function over a 24-week study period;~     to evaluate criteria for early assessment of response to fampridine that can predict~     clinically meaningful benefits in walking ability and balance; to assess the safety and~     tolerability of prolonged-release fampridine 10 mg twice daily over a 24-week treatment~     period.~   "
102943|NCT02219919|"~     This randomized clinical trial will investigate changes in pain intensity and nociceptive~     gain processing after the application of either physical therapy or surgery in women with~     carpal tunnel syndrome (CTS). The purpose of this study will be to determine changes in pain~     intensity, widespread pressure pain sensitivity and segmental thermal changes after the~     application of a physical therapy program based on desensitization maneuvers of the central~     nervous system or endoscopic surgery in women with CTS at medium and long-term follow-up~     periods. We hypothesize that the physical therapy intervention targeted to desensitization of~     the central nervous system is more effective than surgical intervention for modulating~     altered nociceptive gain processing in women with CTS.~   "
102944|NCT02219906|"~     Metabolic syndrome is a group of risk factors that increase a patient's likelihood for heart~     attack, stroke and diabetes. Our research is aimed at understanding whether a drug,~     resveratrol, commonly found in grapes and red wine, would have any benefit in reducing risk~     factors in patients that have metabolic syndrome. Despite the use of aspirin and cholesterol~     reducing medications, patients with metabolic syndrome still often have sticky platelets and~     dysfunctional lipid profile. This is likely due to inflammation and high oxidative state. In~     animal studies, this drug has reduced platelet stickiness and reduced oxidative stress.~     However, the effects of this drug have not been researched in patients with metabolic~     syndrome.~      We are interested in studying whether the benefits of resveratrol described in animal models~     can be translated to patients with metabolic syndrome who display high markers of oxidative~     stress. We plan to give a short intervention of drug to patients and then determine if the~     drug successfully:~        1. Decreases the stickiness of platelets. This is important because sticky platelets are~          more likely to form clot and contribute to plaque formation.~        2. Reduce the circulating dysfunctional HDL. HDL and its protein and lipid constituents~          help to inhibit oxidation, inflammation, activation of the blood vessel wall,~          coagulation, and platelet aggregation. Dysfunctional HDL, as occurs in metabolic~          syndrome patients, cannot properly protect against atherosclerosis.~   "
102945|NCT02219893|"~     The purpose of this study is through a phase I/II clinical trial to assess the safety and~     toxicity of intraperitoneally administered MOC31PE immunotoxin, given on the 1.postoperative~     day after cytoreductive surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC)~     for peritoneal metastases from colorectal cancer (CRC).~   "
102946|NCT02219880|"~     The use of Kava in Generalised Anxiety Disorder: an 18-week double-blind, randomised,~     placebo-controlled study.~   "
102947|NCT02219867|"~     Ketamine has been safely used for induction and maintenance of anesthesia for decades and~     more recently has been used for chronic pain. Ketamine is a noncompetitive, high-affinity~     antagonist of the N-methyl-D-aspartate type glutamate receptor, with additional effects on~     dopamine and μ-opioid receptors. During the last 9 years several uncontrolled reports have~     been published, showing a rapid and impressive effect of ketamine in TRD patients (Berman,~     Cappiello et al. 2000; Zarate, Singh et al. 2006; Mathew, Murrough et al. 2010; Aan Het Rot,~     Zarate et al. 2012; Mathew, Shah et al. 2012; Murrough, Iosifescu et al. 2013). Recently~     three placebo-controlled trials showed that a single dose of sub-anesthetic, (0.5 mg/kg) slow~     intravenous (IV) ketamine improves depressive symptoms dramatically. Across studies, a~     clinically significant antidepressant response was maintained for up to 72 hours in 12 of 25~     patients. Nonetheless, all but two patients relapsed <2 weeks post-ketamine (Zarate, Singh et~     al. 2006; aan Het Rot, Zarate et al. 2012). Rot et al. showed that repeated IV ketamine~     infusions prolongs the duration of improvement.~      The investigators believe that the data presented above allows us to provide ketamine~     treatment here in the Sheba Medical Center for TRD patients.~   "
102948|NCT02219854|"~     Laparoscopic distal subtotal gastrectomy with lymph node dissection for treatment of gastric~     cancer is popular in East Asian countries. However, the long-term follow-up outcome based on~     randomized clinical trial (RCT) is still rare. Some studies indicated that laparoscopic~     distal subtotal gastrectomy with D2 lymphadenectomy is a technically feasible and safe~     procedure by experienced surgeons in high-volume specialized hospitals. However, the~     application of it is still limited because of lack of solid evidence on the oncologic~     efficacy. Nowadays, the proportion of patients with locally advanced gastric cancer is~     estimated up to 80 percent of all gastric cancer cases in China. Before the clinical~     application of laparoscopic procedure for the treatment with curative intent to advanced~     gastric cancer located at the middle- or lower-third of the stomach, the oncologic efficacy~     must be verified.Accordingly, the comparison of long-term outcome between laparoscopic and~     open distal subtotal gastrectomy with D2 lymphadenectomy for locally advanced gastric cancer~     based on a well designed RCT is needed.~   "
102949|NCT02219841|"~     This prospective randomized pilot study aims to evaluate the impact of aggressive life style~     modification in terms of calorie-controlled diet and supervised exercise on outcome of~     catheter ablation in overweight and obese patients with atrial fibrillation.~      Hypothesis: Weight loss and management by adoption of strict diet and exercise regimen~     improves the chances of freedom from recurrence following catheter ablation.~   "
102950|NCT02219828|"~     Recent findings suggest that recurrent pericarditis (RP) may be a previously unrecognized~     autoinflammatory disease. The pivotal pathogenic role of interleukin (IL)-1 in RP has been~     shown by the achievement of complete responses after treatment with the recombinant~     IL-1-receptor antagonist, anakinra. Anakinra is the recombinant form of IL-1Ra. The proposed~     study is designed to demonstarate the efficacy of anakinra in RP.~   "
102951|NCT02219815|"~     The PREHAB study is a clinical trial where frail patients waiting for heart surgery are~     randomly chosen to either receive the current standard of care or to participate in an 8-week~     exercise/education program at a community-based cardiac rehabilitation facility. Patients can~     wait for elective heart surgery for as long as 3-4 months. During this time, individuals are~     often fearful of making things worse, causing them to stop being active and further~     deteriorate their physical condition. This wait period presents a potential opportunity for~     health care providers to engage the patient to take control of their self-managed care prior~     to surgery with the intent of improving post-surgical outcomes. Patients randomized to the~     PREHAB intervention group will participate in supervised exercise twice per week in a program~     designed to improve physical functioning and exercise capacity. The investigators hypothesize~     that the PREHAB program for frail elderly patients awaiting an elective cardiac surgery will~     reduce frailty, improve exercise capacity, improve physical activity behaviour, improve~     in-hospital outcomes, improve clinical outcomes 3 months and 1 year postoperatively, and~     improve overall quality of life.~   "
102963|NCT02219659|"~     A three-arm, randomized, pilot feasibility, study to assess the effect three validated~     sedation strategies on outcomes of patient on mechanical ventilation.~   "
103093|NCT02217956|"~     HCIP has shown efficacy in treatment of peritoneal carcinosis from colorectal background. Few~     studies have been published on the use of HCIP in peritoneal carcinosis from ovarian~     background but most of them were non-randomized phase II studies on a small population using~     different type of drugs and dosage. before this heterogeneity it seems necessary to~     standardize the utilization modalities of HCIP in peritoneal carcinosis from ovarian~     background~   "
102952|NCT02219802|"~     Rationale: Compared with balloon angioplasty, implantation of bare metal stents (BMS) and~     drug eluting stents (DES) have shown to reduce repeat target lesion revascularization in~     primary percutaneous coronary intervention (PPCI). However, this did not result in a~     reduction of mortality or recurrent myocardial infarction. Furthermore, there are concerns of~     the occurrence of stent thrombosis. The PAPPA-pilot study, evaluating safety and feasibility~     of using a drug-coated balloon (DCB) only strategy in PPCI, showed good short- and long-term~     clinical results, with sustained safety and efficacy at 12 months follow-up. To date little~     is known about the long-term effects of this treatment modality in STEMI. Besides,~     angiographic follow-up is of great clinical importance by giving insight on the treated~     infarct lesion and to assess the functional angioplasty result.~      Objective: This randomized controlled, non-inferiority trial is mainly designed to~     prospectively assess the safety and efficacy of a CE-marked paclitaxel-eluting balloon only~     strategy vs. third generation DES in the setting of a ST-elevation myocardial infarction~     (STEMI).~   "
102953|NCT02219789|"~     This phase I trial studies the side effects and best dose of alisertib when given together~     with fulvestrant in treating patients with hormone positive breast cancer that has spread to~     other parts of the body or has spread from where it started to nearby tissue or lymph nodes~     and cannot be removed by surgery. Alisertib may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth. Estrogen and progesterone are type of hormones~     made by the body and they can cause the growth of breast cancer cells. Hormone therapy using~     fulvestrant may fight breast cancer by lowering the amount of estrogen or progesterone the~     body makes. Giving alisertib together with fulvestrant may be a better treatment for breast~     cancer.~   "
102954|NCT02219776|"~     Despite the use of a standard preoperative skin disinfectant prior to shoulder surgery~     propionibacterium acne remains a leading cause of post-operative infections. The purpose of~     this study is to evaluate effectiveness of topical benzoyl peroxide as an adjuvant to~     chlorhexidine-impregnated skin preparation in attempting to lower the colonization~     propionibacterium acne prior to surgery. This study will take cultures from patients who are~     randomly assigned into groups that receive and do not receive benzoyl peroxide as additional~     skin prep prior to elective shoulder surgery and compare quantified culture results.~   "
102955|NCT02219763|"~     Evaluate the impact of a 12-week behavioral weight management program on body weight and~     quality of life. We hypothesize that participants will lose body weight and see improved~     quality of life after program completion.~   "
102956|NCT02219750|"~     Comparison of efficacy and safety of different insulin regimens between basal bolus and~     premixed insulin in poorly controlled type 2 diabetes~   "
102957|NCT02219737|"~     This phase I trial studies the side effects and best dose of ibrutinib when given together~     with rituximab, ifosfamide, carboplatin, and etoposide (combination chemotherapy) in treating~     patients with diffuse large B-cell lymphoma (DLBCL) that has returned after a period of~     improvement (relapsed) or has not responded to treatment (refractory). Ibrutinib may stop the~     growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as, rituximab, ifosfamide, carboplatin, and etoposide, work in different~     ways to stop the growth of cancer cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Giving ibrutinib together with combination~     chemotherapy may be a better treatment for patients with relapsed or refractory DLBCL.~   "
102958|NCT02219724|"~     This is a first-in-human, Phase 1, open-label, multicenter, dose-escalation study designed to~     evaluate the safety, tolerability, and pharmacokinetics of MOXR0916 administered~     intravenously in participants with locally advanced or metastatic solid tumors that have~     progressed after all available standard therapy or for which standard therapy has proven to~     be ineffective or intolerable, or is considered inappropriate. This study will consist of a~     screening period, an initial treatment period, a re-treatment period (for participants who~     discontinue MOXR0916 after demonstration of prolonged clinical benefit), and a post-treatment~     follow-up period. Participants will be enrolled in two stages: a dose-escalation stage and an~     expansion stage. The planned duration of the study is approximately 3 years.~   "
102959|NCT02219711|"~     MGCD516 is a receptor tyrosine kinase (RTK) inhibitor shown in preclinical models to inhibit~     a closely related spectrum of RTKs including MET, AXL, MER, and members of the VEGFR, PDGFR,~     DDR2, TRK and Eph families. In this study, MGCD516 is orally administered to patients with~     advanced solid tumor malignancies to evaluate its safety, pharmacokinetic, metabolism,~     pharmacodynamic and clinical activity profiles.~      During the Phase 1 segment, the dose and regimen of MGCD516 will be assessed; during the~     Phase 1b segment, the clinical activity of MGCD516 will be evaluated in selected patient~     populations.~      Patients anticipated to be enrolled in Phase 1b will be selected based upon having a tumor~     type, including but not limited to, non small cell lung cancer and head and neck cancer~     positive for specific activating MET, NTRK2, NTRK3, or DDR2 mutations, MET or KIT/PDGFRA/KDR~     gene amplification, selected gene rearrangements involving the MET, RET, AXL, NTRK1, or NTRK3~     gene loci, or having loss of function mutations in the CBL gene. In addition patients with~     clear cell renal cell carcinoma refractory to angiogenesis inhibitors or metastatic prostate~     cancer with bone metastasis will be enrolled.~   "
102960|NCT02219698|"~     The purpose of this study is to determine the safety and efficacy of symptomatic treatment~     (i.e. without antimicrobial drugs) of acute uncomplicated diverticulitis.~   "
102961|NCT02219685|"~     The primary objectives of this study are to evaluate the effect of sustained virologic~     response (SVR) on cerebral metabolism as determined by magnetic resonance spectroscopy (MRS)~     and on neurocognition as measured by neurocognitive tests. This study will also evaluate the~     antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose~     combination (FDC) for 12 weeks in treatment-naive or treatment-experienced adults.~      During the blinded treatment phase, participants will be randomized 2:1 to receive LDV/SOF~     FDC or placebo for 12 weeks. After the unblinding at the Posttreatment Week 4 visit,~     participants in the placebo group will be offered open-label treatment of LDV/SOF FDC for 12~     weeks.~   "
102962|NCT02219672|"~     This study is a prospective trial which will recruit 18 patients in acute HIV-1 infection~     phase. This study aims to evaluate the effects and side effects of ARV treatment in Chinese~     patients in acute HIV-1 infection phase, and to evaluate the impact of Triptolide wilfordii~     on HIV-1 reservoir.~   "
102964|NCT02219646|"~     Given the protective effect of nitric oxide (NO) on the endothelium and the results obtained~     so far in short-term, continuous treatment with phosphodiesterase-5 (PDE5) inhibitors on~     parameters of endothelial function, we hypothesise that chronic treatment with vardenafil can~     prevent or delay the deterioration of systemic endothelial function in patients with type 2~     diabetes mellitus. The favourable effect of PDE5 inhibitors on sexual function in these~     patients has been convincingly demonstrated in the past. Here we hypothesise that vardenafil~     treatment can have beneficial effects on the vascular physiology in other body districts,~     possibly preventing the development of microangiopathy and atherosclerotic cardiovascular~     disease in these patients.~      The main goal of this study is therefore to monitor the endothelial dysfunction during~     continuous treatment with vardenafil for 6 months; object of the study will be endothelin 1~     and other known parameters of endothelial damage in newly diagnosed patients with type 2~     diabetes mellitus.~   "
102965|NCT02219633|"~     The aim of this trial is to assess the efficacy of LEO 39652 cream compared with LEO 39652~     cream vehicle in adults with mild to moderate AD after 3 weeks of treatment.~   "
102966|NCT02219620|"~     To examine the effects of a music, imagery, and movement (MiM) intervention on emotional and~     cognitive functioning in residents living in a community-based adult long-term care facility.~      Hypothesis 1: Residents who participate in the MiM group will improve in emotional~     functioning, as compared to residents in the control group.~      Hypothesis 2: Residents who participate in the MiM group will improve in cognitive~     functioning, as compared to residents in the control group.~   "
102967|NCT02219607|"~     The use of epidural anesthesia and postoperative analgesia influences fluid balance following~     colorectal surgery.~      Markers such as BNP (brain natriuretic peptide) and liver function enzymes can estimate~     intravascular fluid load and predict outcome after colorectal surgery.~   "
102968|NCT02219594|"~     In-stent restenosis is a major reason of coronary heart disease recurrence .Even in drug~     eluting stent(DES), Restenosis rate could be up to 10% in diabetes and complex lesions though~     it was about 3-5% in general. It is particularly important that in-stent restenosis after~     implantation was early diagnosed and detected. The evaluation of OCT imaging is more accurate~     for narrow area calculation, more clear for narrow organization structure and more specific~     for detecting tissue types.It is currently the best way for restenosis histologic~     diagnosis.But it has many weakness such as the higher cost,an invasive test, expensive~     instrument, relatively complicated to operate,and etc.In this study, OCT image was regard as~     the gold standard of stent restenosis.~      The improvement of spatial resolution of Gemstone CT can effectively improve the imaging~     quality and the measurement's accuracy of coronary artery stents.The diagnostic value of~     in-stent restenosis of Gemstone CT is higher than of the 320-detector row spiral CT. To a~     certain extent, the gemstone CT can replace OCT for examining the in-stent restenosis.~      This study will examine the degree of in-stent restenosis by the gemstone CT and the~     320-detector row spiral CT and compare the two ways on the basis of the result of OCT.~   "
102969|NCT02219581|"~     The purpose of this study is to evaluate if the use of two small doses of intravenous (IV)~     steroids around the time of knee replacement surgery decrease a patient's pain or use of pain~     medication. The investigators will also determine if the subjects receiving the steroid will~     have better pain control and better postoperative outcomes after their surgery.~   "
102970|NCT02219568|"~     The purpose of this study is to compare the efficacy between video capsule endoscopy and CT~     enterography in diagnosis of obscure gastrointestinal bleeding.~   "
102971|NCT02219555|"~     We hypothesize that the ultrasound detectable variations in nerve, tendon and SSCT mobility~     in patients with CTS may be useful clinically, not to diagnose CTS, but instead as functional~     biomarkers that correlate with, and thereby serve as predictors for, treatment response. To~     test this hypothesis, we propose a longitudinal clinical study in which patients presenting~     for treatment of CTS will be monitored by ultrasound and by clinical assessment before and~     after non-surgical and surgical treatment. We will correlate the clinical outcomes with the~     initial ultrasound motion patterns that we have found to be most variable in CTS patients. We~     will also test the hypothesis that successful treatment results in a change towards normal in~     the affected ultrasound variables.~   "
102972|NCT02219542|"~     The investigators designed a study to determine whether with combined general-transversus~     abdominis plane block anesthesia or standard general anaesthetic would provide same level of~     cytokines in patients undergoing Laparoscopic Colonic Surgery.~   "
102973|NCT02219529|"~     A new Magnetic-controlled Capsule Endoscopy (MCE) was developed by ANKON and got SFDA's~     approval in China in 2013. It has recently been evaluated to compare the diagnostic accuracy~     of MCE with that of standard gastroscopy for gastric diseases in 70 patients with encouraging~     results (In Press). To further testify the diagnostic accuracy of MCE for both the diffuse~     and focal diseases in stomach, we performed this single-blinded multi-center prospective~     study compared MCE with gastroscopy in patients with gastric symptoms and indication for~     upper GI Endoscopy.~   "
102974|NCT02219516|"~     This is a Phase 1, single-dose, open-label, pharmacokinetic (PK) and pharmacodynamic (PD)~     study of RDEA3170 in adult male subjects with mild, moderate, and severe renal impairment.~   "
102975|NCT02219503|"~     The purpose of this study was to evaluate the safety and efficacy of ombitasvir/~     paritaprevir/ ritonavir and dasabuvir in adults with genotype 1b chronic hepatitis C virus~     (HCV) infection and cirrhosis.~   "
102976|NCT02219490|"~     The purpose of this study is to evaluate Long-term outcomes following treatment with~     ABT-450/r/ABT-267 and ABT-333 with or without RBV in adults with genotype 1 Chronic Hepatitis~     C Virus (HCV) infection.~   "
102977|NCT02219477|"~     The primary objectives of this study are to assess the safety and the SVR12 rate of~     ombitasvir/paritaprevir/ritonavir and dasabuvir with RBV in GT1-infected participants with~     decompensated cirrhosis.~   "
102978|NCT02219464|"~     The investigators plan to conduct a randomized, controlled trial comparing nasopharyngeal~     oxygen supplementation to traditional nasal cannula in patients undergoing oral surgery under~     moderate sedation.~   "
102979|NCT02219451|"~     The purpose of this study is to verify the effects of exercise training on sympathetic~     modulation and arterial baroreflex control in patients with chronic heart failure.~   "
103094|NCT02217943|"~     The primary goal of this study is to assess impact of metabolic surgery on glycemic control~     in diabetic patients.~   "
102980|NCT02219438|"~     Patients usually experience moderate-to-severe pain following the knee replacement that is~     often treated with a femoral nerve block (injection of numbing medicine placed around the~     main nerve of the knee joint). To make the nerve block last longer, a tiny tube is often~     placed next to the nerve and numbing medicine is infused for multiple days. However, while~     the numbing medicine takes away pain, it also decreases sensations, muscle strength, and~     proprioception (knowing where the leg is in space without looking at it) which greatly~     increases the risk of falling. Since falling can be catastrophic following major surgery, a~     femoral nerve blocks are being phased out by surgeons and anesthesiologists. The~     most-promising replacement is called an adductor canal nerve block. For this new type of~     block, a perineural catheter is inserted into a small canal in the middle of the upper leg.~     This canal contains the sensory nerve fibers leading to the knee, and only a single nerve~     that serves a relatively small muscle. Multiple studies have demonstrated a dramatic increase~     in muscle strength using the new adductor canal block compared with the traditional femoral~     block. However, practitioners perceptions of the new block is that it provides insufficient~     pain control following knee arthroplasty, even though all of the sensory nerves affected with~     the femoral block are also—theoretically—affected with the adductor canal block. One reason~     for this difference may be the small canal of the latter which is a relatively tight area in~     which the numbing medicine might not spread particularly well (due to pressure from~     surrounding tissues). One way to possibly counter this issue is by providing repeated boluses~     of the numbing medicine that will improve the medicine's spread relative to a~     more-traditional slow, continuous (basal) infusion. This study seeks to compare these two~     techniques of medication administration through perineural adductor canal catheters:~      Our primary aim is to test the hypothesis that, for continuous adductor canal blocks,~     providing local anesthetic as repeated, hourly bolus doses results in an increased sensory~     block compared with providing local anesthetic as a continuous basal infusion at an~     equivalent hourly dose.~      As a secondary aim, we hypothesize that, for continuous adductor canal blocks, providing~     local anesthetic as repeated, hourly bolus doses results in either equivalent or less motor~     block compared with providing local anesthetic as a continuous basal infusion at an~     equivalent hourly dose.~   "
102981|NCT02219425|"~     The aim of this study is to evaluate the gene expression of the endometrium after an~     endometrial biopsy in fertile women using Next Generation Sequencing of total RNA.~   "
102982|NCT02219412|"~     This study was a feasibility trial that was designed to provide preliminary observations and~     generate hypotheses for future studies. The aim of the study is to estimate the difference of~     arachidonic acid induced platelet aggregation rate between ticagrelor mono-therapy and~     aspirin/ticagrelor dual-therapy after 14 days of treatment in patients with stable coronary~     artery disease. The potential hypothesis is that the arachidonic acid (AA) induced platelet~     aggregation rate after 2 weeks of ticagrelor mono-therapy is comparable to that of~     aspirin/ticagrelor dual-therapy.~   "
102983|NCT02219399|"~     Supplementation with DHA during pregnancy will increase gestational length and improve~     cognitive development.~   "
102984|NCT02219386|"~     Deep dry needling of active myofascial trigger points of trapezius muscle is effective in the~     dimminution of pain of patients~   "
102985|NCT02219373|"~     Given the widespread use of anticonvulsants in the pediatric chronic pain population and the~     absence of scientific data supporting their use, the investigators propose a randomized,~     double blind, two group parallel design in which a broad group of children and adolescents~     with chronic neuropathic pain would be randomized to receive either Gabapentin or~     Oxcarbazepine.~      The Primary Aim of the Study is to assess the frequencies of successful treatment of~     pediatric patients with neuropathic pain treated with either Gabapentin or Oxcarbazepine.~      The Primary Hypotheses are as follows:~      Hypothesis I: Both Gabapentin and Oxcarbazepine will result in significant reduction in pain~     scores when compared to each patient's baseline.~      Hypothesis II: Patients who continue on active drug (Gabapentin or Oxcarbazepine) during the~     second phase of the trial will report greater pain reduction relative to baseline than~     patients who are randomized onto placebo at this randomization point.~      Secondary Aims of the Study are to compare groups treated initially with Gabapentin or~     Oxcarbazepine with regard to reduction in pain scores (both at rest and with evoked~     maneuvers), functional disability scores, tolerability, and measures of mood and cognitive~     functioning.~      Secondary Hypotheses are that Gabapentin and Oxcarbazepine differ in their effects on:~        1. Pain scores at rest and with evoked maneuvers~        2. Functional disability scores~        3. Tolerability (frequencies of side-effects)~        4. Depression and anxiety scales~        5. Neuropsychological measures of cognitive processing speed, working memory, and~          attention.~   "
102986|NCT02219360|"~     Chronic obstructive pulmonary disease has become a serious global health care and public~     health problems due to its high prevalence, high morbidity and heavy economic burden. Acute~     exacerbation of chronic obstructive pulmonary disease is one of the most important causes of~     death in patients with COPD. Systemic corticosteroids therapy is recommended in COPD~     exacerbations. In clinical practice for the treatment of acute exacerbation of COPD，~     antibiotic application is still controversial. Evidence from current guideline is based on~     strict criteria from randomized controlled trials, thus the given condition is simplified.~     Patients meet the criteria account for the minority in the real world. Therefore, it is still~     not clear whether most patients benefit from the recommended treatment. In our design,~     hospitalized patients with acute exacerbation of COPD will be enrolled, with their treatment,~     arterial hypoxemia, recovery time and length of hospitalization being observed. The main~     purpose is to evaluate the benefit effect of current recommended treatment of acute~     exacerbation of COPD in the real world.~   "
102987|NCT02219347|"~     Rheumatoid arthritis is a common condition affecting approximately 1% of the United Kingdom~     population; it is an autoimmune disease where the body's natural defences (the immune system)~     attack the body itself resulting, most notably, in joint damage and arthritis. To help~     prevent this, patients with rheumatoid arthritis need to take disease-modifying~     anti-rheumatic drugs (DMARDs). As rheumatoid arthritis is a life-long condition, these drug~     treatments are prescribed as long-term medications taken for many years.~      With successful drug treatment, many patients are able to achieve an excellent control of~     their disease and their arthritis can go in to remission. At present, there are no markers~     which can reliably predict which of these patients can reduce their drug treatment, and hence~     benefit from a lower risk of side effects and inconvenience, without an increase in their~     arthritis activity.~      We invite patients with stable rheumatoid arthritis to participate in this study conducted by~     Newcastle upon Tyne Hospitals NHS Foundation Trust in collaboration with Newcastle University~     and funded by the Wellcome Trust. Patients whose arthritis is confirmed as being in remission~     will be able to stop their DMARD medication and be monitored for a period of 6 months.~     Patients whose arthritis activity increases during this time will be able to restart their~     DMARD medication, whereas those patients whose arthritis remains in remission will be able to~     stay off DMARD medication.~      The main aim of this study is to identify clinical, ultrasound and blood markers that can~     predict which patients will remain in remission after stopping DMARD medication. If~     identified, these markers could be a useful guide to doctors and patients in the future when~     deciding whether to stop DMARD therapy.~   "
102989|NCT02219321|"~     Prescription drug abuse represents a major healthcare problem, with treatment costs reaching~     billions of dollars annually in the United States alone. Today opioids are commonly~     prescribed for chronic non-cancer pain and are only partially effective for short-term pain~     relief. Whereas opioids are initially part of the solution for pain, it eventually often~     turns to be a problem in patient with chronic pain. Long-term treatment with opioids can be~     complicated by development of tolerance, dependency, addiction, abnormal pain sensitivity,~     hormonal changes, and immune modulation. Unfortunately, the chronic use of anti-inflammatory~     drugs is associated with a marked increase in adverse effects.~      The purpose of this study is to determine whether systemic administration of lidocaine~     provides effective pain relief in opioid dependent chronic pain patients. Investigators~     intend to demonstrate that lidocaine infusion can improve pain relief and physical function~     in opioid dependent patients, thus improving compliance and patient satisfaction, which may~     potentially help wean patients off narcotics. The long-term goal of this proposal is to~     decrease opioid dependence in chronic pain patients by using lidocaine infusion.~   "
102990|NCT02219308|"~     Intrauterine device (IUD) placement can be painful for patients during and after the~     procedure. Fear of pain from IUD insertion can be a barrier to obtaining this highly~     effective long acting reversible contraception. Currently there are no proven effective~     methods for reduction of pain during and after placement of modern IUDs. Paracervical block~     pain may decrease this placement pain.~   "
102991|NCT02219295|"~     We investigate the impact of taste receptors (sweet, bitter and umami) on human metabolism.~     There ist growing evidence, that components of the taste signalling system, including the~     taste receptor proteins , have important functions in the regulation of metabolic parameters~     in non-gustatory tissues.~   "
102992|NCT02219282|"~     As a result of rises in living standards quality of life is progressively increasing.~     Combined with developments in anesthesia, surgical techniques and medication allowing more~     difficult and complicated interventions to be carried out, elderly patients are encountered~     more often in daily anesthetic practice.Reduced tone in the upper airway of geriatric~     patients increases the possibility of airway obstruction. In old patients with no teeth,~     sunken cheeks may make ventilation with a mask ineffective; perhaps even impossible.~      In addition to our observations that Laryngeal mask (LM) is more difficult to place in older~     patients, in the literature there are very few studies on the use of LM in older patients.~     Sixty percent of patients over the age of 65 have no teeth. Ventilation with a mask is more~     difficult for patients without teeth compared to those with teeth. Laryngeal mask is an~     alternative airway device for patients without teeth when the face mask does not sit~     correctly.~      The aim of this study is primarily to measure the success of placement on first try, ease and~     duration of insertion and oropharyngeal leak pressure of laryngeal mask Unique (LMU) in~     patients 65 years of age and above dentulous and edentulous elderly patients. The secondary~     aim is to compare the effects on the hemodynamic response occurring during placement.~   "
102993|NCT02219269|"~     The investigators will conduct a prospective observational cohort study to investigate~     factors that influence contraceptive method utilization among women with medical conditions.~     The investigators will also investigate how women with medical conditions access to~     contraception and family planning fellowship trained specialist. After the baseline~     questionnaire, there be a 3 month and 6 month follow up questionnaire to investigate~     continuation and satisfaction with the contraceptive method. This study is unique because it~     will allow us to explore doing collaborative family planning research at the multiple UC~     medical campuses.~   "
102994|NCT02219256|"~     The purpose of this study is to characterize the pharmacokinetic and safety and tolerability~     profile of TAK-079 following a single intravenous (IV) infusion or subcutaneous (SC)~     administration at escalating dose levels in healthy participants.~   "
102995|NCT02219243|"~     A substantial number of children with social anxiety fail to gain benefit from contemporary~     cognitive-behavior therapy (CBT) approaches. More novel treatment approaches for treatment of~     social anxiety are needed. The current study attempts to modify an interpretation style that~     is characteristic of children who also display high anxiety in social situations.~     Participants between the ages of 8-12 years old, with social anxiety, will be randomly~     assigned to one of three treatment conditions: two conditions are designed to manipulate the~     interpretation bias or a wait-list control condition. All study procedures will be conducted~     online. This study will help develop an effective cognitive intervention program for social~     anxiety in children.~   "
102996|NCT02219230|"~     The goals of this study are to assess measured, observed, and self-reported outcomes achieved~     through the use of passive (mechanical), active(motorized) and adaptive (magnetorheological)~     prosthetic knee control systems in individuals with unilateral, transfemoral amputation.~   "
102997|NCT02219217|"~     The purpose of the study is to look at the levels of three HIV medications: dolutegravir,~     elvitegravir and cobicistat in blood after the drug intake has been stopped in order to~     understand how long these drugs persist in the blood. The study will specifically look at~     blood levels of these three drugs after taking them every day for 10 days dolutegravir on a~     first stage and a combination of elitegravir and cobicistat in a second stage.~      If the participant decides to take part, the duration of the study will be up to 38 days plus~     a screening visit which will take place up to 28 days prior to the start of the study, and a~     follow up visit which takes place 7 to 14 days after the last dose of study medication.~      This study is not randomised which means that all participants will receive all study~     medications in the same order. The participant and the study doctor will know which study~     medications the participant is taking at all times during the study.~   "
103043|NCT02218619|"~     Clinically, the ability to slow or prevent beta cell demise can prevent or improve the course~     of type 1 diabetes. The immune-mediated destruction of beta cells that is an apparent major~     pathological basis for the disease, has led to efforts to prevent or suppress this immune~     assault. Here we propose to buttress the beta cell's capacity to withstand this assault by~     improving the function of the endoplasmic reticulum stress resolving mechanisms within these~     cells. The ability to do so could have a major impact on preventive and therapeutic~     strategies for type 1 diabetes (and possibly other types of diabetes). The type of~     endoplasmic reticulum stress relieving agent (TUDCA) proposed here could ultimately be~     applied on an anticipatory basis to individuals at high risk for type 1 diabetes.~   "
102998|NCT02219204|"~     Dry eye is a major, common medical condition with significant health and economic burden in~     Singapore and worldwide. It is a holistic problem affected by living habits, nutrition and~     underlying systemic disease, inducing a significant decrease in quality-of-life. The hallmark~     of this disease is raised tear osmolarity and inflammation. There is no definitive cure for~     this condition, as treatment in the form of lubricants is only symptomatic and treatment with~     cyclosporine eyedrops is expensive and may not be well tolerated.~      Following the rise in international interest in complementary medicine, randomized-controlled~     studies in dry eye using Traditional Chinese Medicine (TCM) have been published, with mixed~     results. However, the major limitation of these studies is the lack of objective assessment~     for inflammation.~      We propose to collaborate with an academically-trained Singapore TCM physician who has~     conducted dry eye trials, and synergistically exploit the existing state-of-the-art dry eye~     monitoring technologies available at Singapore Eye Research Institute (SERI). This proposal~     is cost-effective, building on previous government grants and expertise to provide definitive~     scientific evidence on the efficacy and safety of TCM in dry eye. SERI has an international~     reputation for interventional studies, and the PI has a good academic relationship with the~     above TCM physician. We propose to screen, recruit and treat 150 patients with a herbal~     preparation and acupuncture, and evaluate over 4 weeks in a randomized-controlled study.~     Tests to be performed will include tear imaging and osmolarity, as well as protein and~     cytokine assays.~      Singapore is uniquely positioned at the crossroads of the East and the West to take the lead~     in this field. Given that there is an increasing patient interest in holistic care in~     Singapore and the rise of scientifically trained TCM practitioners, a study like this one is~     very timely, and will have tremendous impact to healthcare delivery in Singapore.~   "
102999|NCT02219191|"~     To evaluate the Effect of Puerarin tablets versus statins in treating metabolism syndrome in~     patients with chronic rheumatic diseases~   "
103000|NCT02219178|"~     This study aims to evaluate the overall response rate after 4 cycles and the best response to~     induction therapy with combination of lenalidomide, subcutaneous bortezomib, and~     dexamethasone (RsqVD) in patients with newly diagnosed multiple myeloma.~   "
103001|NCT02219165|"~     Staphylococcus aureus and Streptococcus pyogenes produce many virulence factors. Some of them~     are responsible for severe infections in humans. Superantigen toxins synthesized by S. aureus~     or by S. pyogenes, are responsible for toxic shock syndromes (TSS) which lethality can attain~     25% in children with validated criteria of septic shock.~      Previous studies, performed in vitro and in vivo in animals, have shown that Intravenous~     immunoglobulins [IVIG] contain antibodies [Ab] against these toxins and, when used at high~     concentration, IVIG are able to neutralize their toxicity. However, in all these studies,~     IVIG administration has been preventive and there is no reliable data demonstrating their~     therapeutic efficacy in vitro or in vivo in humans or in animals, once the disease is~     present.~      The efficacy of IVIG is established in other pathologies for which the role of the~     superantigens [superAg] is suspected, like Kawasaki disease in children. The mechanism of~     action, although not perfectly known, involves at the same time a direct effect on superAg~     (Ag-Ab complex) and indirect effects like the neutralisation of superAg within the network of~     anti-idiotype Ab or the neutralisation of the T-cells receptors. Staphylococcal and~     streptococcal toxic shocks imply bacterial exotoxins that are superAg. It seems thus~     consistent to imagine a same type of treatment with IVIG. However, there is currently no~     evidence of the efficacy of IVIG in this indication. One of the explanations relies on the~     lack of statistical power of previous adult studies, which principal objective was to show a~     reduction of the mortality. Taking into account the low prevalence of TSS, it has been hard~     to recruit enough patients to have the required statistical power. Moreover, some works have~     been extracted from larger studies on septic shock and the definitions of the TSS were nor~     always very reliable. Lastly, if the investigators consider the definition of the TSS as~     mentioned by the  Centre for Disease Control  [CDC], for which any hypotension, even a~     simple orthostatic hypotension, serves the diagnosis of TSS as long as the other symptoms are~     present, it is obvious that many patients are likely to be recruited in a study although it~     is highly probable that their health will get better with a  standard  treatment. The~     definition of a  real  TSS can be refined, keeping the CDC criteria, but changing the~     hypotension criterion in a more accurate criterion as described in the  surviving sepsis~     campaign , internationally accepted and based on norms adapted to the age for paediatric~     forms.~      IVIG therapy is very expensive and TSS is not recognized as indication of IVIG according to~     their marketing authorization. The feasibility of a randomized controlled study with this~     treatment needs to be assessed as it would be hazardous to conduct a large prospective RCT~     without having first assessed this feasibility in terms of recruitment rates, consent rates~     or compliance rates. Inclusion, randomisation and collect of inform consent in the context of~     severe shock are challenging and require evaluation of feasibility. The sample size~     calculation of the large study on mortality required estimations of the event in the specific~     population of children with criteria of septic shock. Surrogates markers of outcome need to~     be better defined. For example it would be useful to determine the evolution of organ~     dysfunctions with and without IVIG treatment in this population.~      Various organ failure scores, used upon admission and later on, have been validated in adults~     and in children. The absence of improvement of the Paediatric logistic organ dysfunction~     (Pelod) score over time is a good indicator of mortality in Paediatric intensive care unit~     (PICU). It could be used as surrogate marker to evaluate the efficacy of IVIG.~   "
103002|NCT02219152|"~     Bleeding during transbronchial ro endobronchial biopsy is rather a common complication.~      Mostly this is an insignificant bleeding, but in 3% of the biopsies there is a substantial~     amount of bleeding that requires a special treatment or follow up.~      The goal of this study is to examine whether submission of tranexamic acid during the biopsy~     could diminish the amount of bleeding.~   "
103003|NCT02219139|"~     Immunologically evaluation of myeloperoxidase level as indicator for inflammatory reactions~     on modified surface abutments compared to machined surface abutments.~   "
103004|NCT02219126|"~     This study aims to investigate differences in digestion rates and stomach problems caused by~     pasteurized and homogenized milk compared with raw milk in healthy adults by ingestible~     capsule that measures pH and pressure, diary of symptoms, blood glucose and triacylglycerol~     levels and plasma cytokine levels.~   "
103005|NCT02219113|"~     Autologous adipose-derived regenerative cells (ADRC) extracted using Celution 800/CRS System~     (Cytori Therapeutics Inc) from a portion of the fat harvested from the patient's front~     abdominal wall. ADRC will be administered one-time intraarticularly. This is a single arm~     study with no control. All patients receive cell therapy.~   "
103006|NCT02219100|"~     This study examined the acceptability and feasibility of using a simplified regimen of~     medical abortion in Armenia and Azerbaijan. It was hypothesized that home use of mifepristone~     and misoprostol, and buccal administration of misoprostol, would be both acceptable to women~     and efficacious.~   "
103007|NCT02219087|"~     The purpose of this study is to determine whether liposomal bupivacaine is effective in the~     management of pain following total knee arthroplasty, as compared to standard of care~     analgesia.~   "
103008|NCT02219074|"~     Prospective, multicenter study with multiple arms to examine the safety and effectiveness of~     the Sebacia Acne Treatment System for the treatment of acne vulgaris.~   "
103009|NCT02219061|"~     Maternal antibodies (measles and meningitis C) may wane in the first six months after birth.~        -  Geometric mean titers(GMTs) of measles and meningitis C.~        -  Follow-up on 0 month, 3rd month,5th month and 7th month after birth.~   "
103010|NCT02219048|"~     The study proposes to evaluate the safety and efficacy of PF-03715455 in moderate to severe~     asthma when added to standard of care and during staged withdrawal of background therapy.~   "
103011|NCT02219035|"~     In patients presenting with acute stroke or transient ischaemic attacks (TIA), von Willebrand~     factor related parameters, including VWF antigen, activity, FVIII:c and propeptides, ADAMTS13~     levels and VWF multimers in cases where ADAMTS 13 was reduced will be measured. Global~     haemostasis will be assessed using thrombin generation and the relation between increase~     thrombin generation and VWF explored. Thrombin generation will be performed pre and post~     filtration for the presence of procoagulant microparticles. These parameters will be~     investigated acutely, at presentation and in convalescence; in addition, the effect on these~     parameters of treatment such as thrombolysis may be informative. Correlation between measured~     parameters and adverse clinical outcome would be used to identify markers of severity and~     progression of ischaemic stroke and identification of potential novel approaches to therapy~     that might improve outcome.~   "
103012|NCT02219022|"~     A randomized controlled trial with rheumatoid arthritis patients will be realized. Patients~     will be randomized into two groups. Experimental group will do a 12 weeks training of~     progressive resistance exercise for global muscles and remain with the clinical treatment and~     the control only remain with the clinical treatment. Patients will be evaluated at baseline,~     after 6, 12 and 24 weeks.~   "
103013|NCT02219009|"~     The purpose of this study is to determine the usability of the Medical Information Device #1~     (MIND1) system in adults with schizophrenia who are treated with oral aripiprazole.~   "
103014|NCT02218996|"~     The purpose of this study is to examine the content of the treatment being delivered for~     anxiety disorders for children and adolescents in the regular outpatient clinics in western~     Norway. The study will also collect data before and after treatment to evaluate the result of~     the treatment. Furthermore, as part of the study we aim to collect normative data on two~     questionnaires used to identify anxiety symptoms and the extent to which anxiety interfere~     with daily functioning. We also aim to develop a quality indicator for anxiety treatment that~     can be used to monitor treatment in the regular outpatient service, based on the results of~     the current study.~   "
103044|NCT02218606|"~     The purpose of this study is to see what effects (good and bad) treatment with abiraterone~     acetate (an oral hormonal agent) and prednisone (a steroid) with and without cabazitaxel (a~     chemotherapy) have on the cancer and to find out more about whether specific laboratory tests~     on tumor are useful in predicting how the patient will respond to treatment.~   "
103015|NCT02218983|"~     Primary caregiver thoracic ultrasound (U/S) is a skill which is growing in utility in~     critical care. First introduced for volume assessment in nephrology and cardiology, it is now~     being researched in emergency and critical care. Data is still evolving in its use in initial~     trauma evaluation. Inferior vena cava (IVC) diameter correlates with outcome in trauma, but~     utility of its measurement on U/S in the emergency department still has some controversy. In~     trauma specifically, small studies suggests benefit to the use of U/S to predict volume~     status, and most of these data are from one author. It is not known if this can be applied~     more broadly. The prognostic value of findings on limited transthoracic echocardiogram (LTTE,~     SonoSite Ultrasound) has been studied in several small studies, and only one small randomized~     controlled trial has proven benefit to its use. Due to inter-rater reliability and the fact~     that all reports on credentialing of thoracic ultrasound use in the trauma bay are from one~     group, it is not known if it can be applied to all trauma populations.~      Research question:~      Does LTTE (SonoSite Ultrasound) predict mortality, emergency surgery, intensive care unit~     (ICU) stay, hospital stay, time on ventilator, number of transfusions, or renal failure as~     well as or better than other methods of organ perfusion?~      Hypotheses:~        1. Use of LTTE is associated with improved outcomes (less organ failure, decreased hospital~          and ICU stays, transfusions, and mortality).~        2. LTTE predicts mortality, emergency surgery, ICU stay, hospital stay, time on ventilator,~          number of and transfusions better than other methods of organ perfusion (tachycardia,~          hypotension, lactate, lactate clearance, creatinine, base deficit).~   "
103016|NCT02218970|"~     Physical health does not have a high priority in today's treatment of patients with substance~     use disorder (SUD). SUD patients have a poor physical health not only due to injuries related~     to the substance abuse, but also because of the addiction-related lifestyle. There are few~     studies today that provide information about SUD patient's physical health, and especially~     there is little information about their muscular strength. One of the project's aims is to~     measure muscular strength in SUD patients who are being treated for their addiction, and see~     if they have decreased neuromuscular function. If so, we will investigate the effect of~     maximal strength training on neuromuscular function in these patients.~   "
103017|NCT02218957|"~     Morbid obesity is an increasing medical problem in the western countries. It's related to~     comorbidities as diabetes mellitus, hypertension, OSAS, arthrosis and hypercholesterolemia.~     The Roux-en-Y Gastric Bypass (RYGB) is an effective surgical therapy for morbidly obese~     patients. A part of these patients will have disappointing results, and have weight regain on~     the long term. Some studies show more weight reduction by increasing the biliopancreatic limb~     in patients with morbid obesity.~      The objective of this study is to investigate the effect of a restrictive/extended pouch on~     weight reduction in morbidly obese patients undergoing RYGB-surgery. We hypothesize that the~     restrictive/extended pouch results in more weight reduction.~      The study design is a prospective, randomized control trial. The patients will be randomized~     in 2 groups: a standard RYGB (normal pouch) and restrictive/extended pouch RYGB.~   "
103018|NCT02218944|"~     The current study tests a response inhibition retraining program, implemented on a mobile~     device, as a mechanism to increase relapse prevention during a smoking cessation attempt.~     Study participants (n = 150) are randomly assigned to a control, benign, or intervention~     condition. They complete 2 weeks of response inhibition retraining, and then engage in a~     cessation attempt. It is hypothesized that individuals who receive the intervention will have~     a decreased likelihood of relapse following the cessation attempt. In addition, it is~     hypothesized that this is due to decreases in implicit smoking motivation as a function of~     the response inhibition training.~   "
103019|NCT02218931|"~     Obesity is a growing problem in East London and every other woman who enters pregnancy is~     obese or overweight. In addition to obesity, other metabolic risk factors such as raised~     lipids, high blood pressure and diabetes increase pregnancy related complications such as~     preeclampsia and long term problems such as heart diseases, stroke and death. Preeclampsia,~     presenting as hypertension and proteinuria is a leading cause of maternal and fetal mortality~     and morbidity. Interventions that reduce cardiovascular events by modifying risk factors also~     have the potential to reduce the risk of preeclampsia. The investigators work funded by the~     National Institute of Health Research (NIHR) in the UK showed that dietary interventions in~     obese pregnant women may reduce the risk of preeclampsia. The investigators propose to show~     that pregnant women with metabolic risk factors derive the most benefit from a simple,~     targeted intervention based on Mediterranean dietary pattern to reduce the risk of maternal~     and fetal complications . Women with the risk factors (1230 women) will be randomly allocated~     to dietary intervention or usual antenatal dietary advice and the risk of maternal and fetal~     complications will be evaluated. The remaining eligible women who are consented for lipid~     tests, but do not have metabolic risk factors, will be followed up for outcome data only.~     Diet based interventions, especially those based on a Mediterranean dietary pattern has a~     potential to reduce the risk of preeclampsia. In the investigators study, pregnant mothers~     with risk factors will be randomly allocated to either a dietary invention or usual antenatal~     care and they will assess their composite maternal (pre-eclampsia or gestational diabetes)~     and fetal (stillbirth, small for gestational age or admission to neonatal intensive care~     unit) outcomes. The investigators will tailor the intervention to suit the individual needs~     of the mother and provide nuts and olive oil to improve compliance. The study will be~     undertaken across the three maternity units at Barts Health NHS Trust, which delivers 17,000~     women/year and two other maternity units in England. The study is supported by the office of~     the Mayor of Tower Hamlets which will facilitate the involvement of grassroots workers to~     promote recruitment and uptake of the intervention.~   "
103020|NCT02218918|"~     Pulmonary Rehabilitation became a vital part of management in COPD patients in form of~     activity modification, dietary and pharmacological optimisation. But access to traditional~     supervised aerobic (treadmill) walking is debatable fact due to economical and staffing~     expertise in developing countries like India. The investigators designed a randomised~     controlled trial to evaluate the effectiveness of ground based walking over traditional~     treadmill walking in improving quality of life in COPD patients.~   "
103021|NCT02218905|"~     This study is to find relation between number of repetitions the volunteer able to sit and~     stand in an armless chair and their age, height, weight and gender. The investigators~     hypothesis there is a moderate relation between anthropometric characteristics and number of~     situps. This may partially define the ability of functional capacity and quadriceps ability.~   "
103045|NCT02218593|"~     This study is to evaluate how the Wilmington Robotic Exoskeleton (WREX) is working for~     children who are using the WREX, or have used it in the past. The survey consists of a set of~     questions a) performed online and b) performed over the phone.~   "
103095|NCT02217930|"~     The study designed to determine the effect induced by WCK 2349 on the QT interval.~      The study will be conducted in two parts: 1) to determine the supratherapeutic dose; and 2)~     to assess the safety of high doses of single-dose administration of WCK 2349 on the QT~     interval.~   "
104256|NCT02202759|"~     The purpose of this study is to assess the efficacy, safety and tolerability of MLN0264 in~     patients with recurrent or metastatic guanylyl cyclase C (GCC)-positive adenocarcinoma of the~     stomach or gastroesophageal junction.~   "
103022|NCT02218892|"~     Purpose and aims The general aim of this project is to improve the diagnostic methods for~     disease activity and identify predictive factors (clinical and radiographic factors, pro- and~     anti-inflammatory mediators in saliva and plasma) for temporomandibular joint (TMJ)~     involvement in juvenile idiopathic arthritis (JIA).~      The hypothesis is that self-reported pain and impaired jaw function together with clinical~     findings correlates well with radiological signs of jaw involvement.~      Null hypothesis: Self-reported pain, impaired jaw function and clinical findings do not~     correlate with radiological signs of jaw involvement.~      Study 1 The aim of this study is to investigate which findings from the patient history and~     from clinical examination that is of significance for diagnostics of TMJ involvement in~     patients with JIA both in a short- and long-term perspective. The patients will be~     followed-up during two years. They will undergo a clinical examination according to Research~     Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD; Dworkin and LeResche 1992) once~     a year and a telephone follow-up sixth months after the clinical examination. Further, the~     clinical findings from the orofacial regions will be compared to their general disease~     activity.~      Study 2 The aim of the second study is to correlate radiological findings and clinical~     findings in order to investigate any early radiological signs of disease activity and~     progression but also to compare the radiographic examination using conventional panoramic~     technique with computer tomography (CT).~   "
103023|NCT02218879|"~     The primary objective is to directly estimate brain glutathione concentrations in vivo using~     H-MRS at 7T before and after initiation of Tecfidera in established multiple sclerosis (MS)~     patients considering switching therapy or being treatment-naive (first line).~   "
103024|NCT02218866|"~     The goal of this research is understand if obesity is a major factor for neuropathy~     development in patients with and without Type 2 diabetes. This study will examine the~     relationship between weight, metabolism, and nerve function and regeneration.~   "
103025|NCT02218853|"~     The objective of this multi-site research collaboration is to test the manifestation and~     distribution of biological markers for psychosis and affect dimensions across the~     schizophrenia/bipolar (SZ-BD) diagnostic boundary, and to examine heritability and genetic~     associations for these biological markers.~   "
103026|NCT02218840|"~     Lovelace Scientific Resources is conducting clinical research study for cigar smokers. This~     study will be evaluating the behaviors of cigar smokers and the short term effects of cigar~     smoking.~      A cigar is defined as a cylinder of tobacco wrapped in a tobacco leaf for smoking. There are~     small cigars with filters that resemble cigarettes and large cigars that do not have filters.~     Because cigars come in so many shapes and sizes, the nicotine content varies as well. The way~     that a cigar smoker consumes the cigar can also have an effect on how much nicotine is~     absorbed. This study seeks to understand nicotine consumption and addiction in cigar smokers.~      Study participation will last 1 to 4 weeks and will include 2 study-related visits. Your~     visits may include a physical exam, medical history review, questionnaires, blood~     collections, providing a urine sample, an exhaled breath test, having your vital signs~     collected and smoking a cigar. You will be videotaped while you smoke your cigar so that we~     can review the technique you use while smoking.~      STUDY HYPOTHESES:~        -  Significant reductions in craving and withdrawal will be reported after ad libitum~          smoking of a cigar compared to self-report prior to cigar smoking.~        -  Cigar smokers will show a range of nicotine dependence, with a subset of users exceeding~          minimal criteria for nicotine dependence.~        -  Levels of nicotine, cotinine, Carbon Monoxide (CO), and~          4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) will increase significantly from~          pre- to post-cigar smoking.~        -  Small cigar/cigarillo users will demonstrate greater levels of dependence and greater~          relief from craving and withdrawal compared to large cigar users.~   "
103027|NCT02218827|"~     Many patients refer to an oculoplastic or corneal clinic examination due to dry eye symptoms.~     epidemiologic studies estimate that as many as 15% of the population over 60 years suffer~     from dry eye. the disease can be treated both topically through several drugs or through~     mechanical closure of the lacrimal drainage system. in the past decade a few studies~     demonstrated the efficacy of anti inflammatory treatment on dry eye disease due to the~     inflammatory process that occurs in it. this treatment rises goblet cell counts but in the~     meantime elevates the intra ocular pressure and elevates the risk for infections. steroids~     that cause a lower increase in intraocular pressure have not been thoroughly evaluated in dry~     eye disease. we with to subjectively and objectively evaluate an FDA approved topical~     steroidal drug in the treatment of dry eye.~   "
103028|NCT02218814|"~     The purpose of this study is to determine if patients undergoing a Total Knee Arthroplasty~     who receive a single shot Adductor Canal nerve block and local infiltration will have~     improved functional outcomes compared to individuals who receive a femoral nerve block and~     local infiltration during the first 24 hours post surgery.~   "
103029|NCT02218801|"~     This prospective database has two main objectives;~        -  to evaluate the complication rates, 30-day and 90-day mortality from different surgical~          strategies for unresectable, borderline resectable or initially unresectable liver~          metastasis from colorectal cancer.~        -  to establish baseline quality parameters for different surgical strategies for~          unresectable, borderline and initially unresectable colorectal liver metastasis (CRLM)~          patients.~   "
103030|NCT02218788|"~     The purpose of this study is to assess the safety and performance of Hydroxytite in all~     subjects who have received sub dermal or deep dermal injections.~   "
103031|NCT02218775|"~     The available treatments for patients with mood and anxiety spectrum disorders have~     significant limitations. This study will contribute significantly to public health by taking~     steps to address these limitations by aiding in the interpretation of a study that: 1) tests~     a promising new treatment for mood and anxiety spectrum disorders; 2) evaluates a potential~     target in the brain which could serve as the basis for development of additional new~     candidate compounds for the treatment of patients with mood and anxiety spectrum disorders;~     3) establishes more expeditious methods for evaluating potential new therapies for patients~     with mood and anxiety spectrum disorders; and 4) specifically establishes methods for the~     development of new therapies targeting anhedonia, an important RDoC (Research Domain~     Criteria) endpoint.~   "
104811|NCT02195492|"~     Retrospective collection of data, aimed at a better knowledge of the context of use of~     Synvisc® among the patients practising a regular activity (professional/leisure), and at~     evaluating the different practices and their results.~   "
103032|NCT02218762|"~     The Fluticasone Propionate/Salmeterol combination (FSC) at a dose of 100/50 micrograms (mcg)~     twice daily in DISKUS inhaler (also known as ACCUHALER®, Ddpi) inhaler is a recognised and~     licensed therapy for the treatment of asthma. GlaxoSmithKline (GSK) is developing the~     ROTAHALER/ ROTACAPS® (Rdpi) inhaler as an alternative treatment option for asthmatic~     patients. This study is a Phase I, randomised, double-blind, double-dummy, two- treatment,~     four-way cross-over (replicate design), two sequence, repeat dose, two centre study in mild~     to moderate asthmatics to compare the pharmacokinetics and pharmacodynamics of fluticasone~     proprionate/salmeterol (100/50 mcg) delivered via the Rdpi versus the Ddpi. A total of 58~     subjects will be enrolled to ensure 52 subjects complete all dosing occasions. Each subject~     will be allocated to one of two treatment sequences and will participate in four treatment~     periods, receiving each of the treatments twice.~      DISKUS, ACCUHALER, ROTAHALER and ROTACAPS are registered trademarks of GSK groups of~     companies.~   "
103033|NCT02218749|"~     The purpose of this study is to determine whether initial triaging to physiotherapists of~     patients with musculoskeletal disorders who seek health care from primary care clinics~     affects the patients health and/or health care utilization differently than initial~     consultation with a general practitioner.~   "
103034|NCT02218736|"~     The available treatment for patients with mood and anxiety disorders have significant~     limitations (Rush, 2007; Denys and de Geus, 2005). There is a need to develop new treatments~     for people with these disorders. Many research studies carried out in animals and a few~     preliminary studies carried out in humans suggest that medications which block kappa opioid~     receptors (KOR) have potential for being effective new treatments for patients with mood and~     anxiety spectrum disorders. These medications have shown particular promise for improving one~     important type of difficulty experienced by many patients who suffer from mood and anxiety~     spectrum disorders referred to as anhedonia, which is an impairment in reward-related~     function. In this study we will test the hypothesis that KOR antagonism is a promising means~     of improving anhedonia in patients with mood and anxiety spectrum disorders. We will do so by~     evaluating whether we can establish Proof of Concept (POC) that a relatively selective KOR~     antagonist, CERC-501 (formerly known as LY2456302), engages neural circuits involved in~     mediating reward-related function in patients with mood and anxiety spectrum disorders with~     anhedonia. We are attempting to establish POC in this study in order to determine whether~     there is a sufficient basis for pursuing future work evaluating whether KOR antagonism has~     therapeutic effects on clinical and behavioral measures of reward-related functioning.~   "
103035|NCT02218723|"~     This is an open-label, five- period, cross-over, randomized, single dose, single centre study~     in healthy subjects. This is the second clinical study for the UD-DPI. This study will~     ascertain whether the Pharmacokinetics (PK) systemic exposure [in terms of area under the~     plasma concentration-time curve (AUC) and maximum observed plasma concentration (Cmax)] of FF~     delivered via the UD-DPI is comparable to the systemic exposure of FF delivered via the~     ELLIPTA Dry Powder Inhaler (DPI). For this reason four treatment doses consisting of three~     dose strengths and 2 percentage blends will be assessed when delivered via the UD-DPI. This~     study is designed to compare the pharmacokinetic profile of various doses and blends of FF~     administered via UD-DPI and relative to FF administered via ELLIPTA DPI. Subjects will be~     screened 28 days prior to study initiation. During each treatment period, subjects will be at~     study site from evening prior to dosing until completion of the 48 hour post-dose PK sample~     collection on Day 3. Minimum 7 days washout will be between treatments after completion of~     all five treatments and the follow-up visit will be conducted 7-14 days post last dose.~     Duration of study is 13 weeks. ELLIPTA is a registered trademark of the GSK group of~     companies.~   "
103036|NCT02218710|"~     The aim of the study is to assess bone geometry, bone compartment specific volumetric~     densities and micro-architecture as well as to evaluate non-invasive estimates of bone~     strength in patients with adult onset growth hormone deficiency.~   "
103037|NCT02218697|"~     The purpose of this study is to investigate the immunogenicity and safety when GSK~     Biologicals' influenza vaccine Influsplit™ Tetra (Fluarix™ Tetra) is co-administered with~     Merck & Co. Inc.'s pneumococcal vaccine (Pneumovax™23/Pneumovax) in adults 50 years of age~     and older at risk for complications from influenza and pneumococcal infections.~   "
103038|NCT02218684|"~     The trial objectives were to investigate the tolerability and pharmacokinetics of 80 mg~     telmisartan and 2, 4 or 6 mg lacidipine administered concurrently.~   "
103039|NCT02218671|"~     Evaluation whether Brotizolam is absorbed through the mucous membrane of oral cavity when WE~     941 OD tablets are administered in Japanese healthy male volunteers.~   "
103040|NCT02218658|"~     The bioequivalence of WE 941 OD tablets prepared in oral disintegrating tablet form taken~     without water and brotizolam conventional tablets (Lendormin® tablets) taken with water, was~     evaluated in healthy adult male subjects (open-labelled, 2-way cross-over study)~   "
103041|NCT02218645|"~     The bioequivalence of WE 941 OD tablets prepared in oral disintegrating tablet form and~     brotizolam conventional tablets (Lendormin® tablets), both taken with water, was evaluated in~     healthy adult male subjects.~   "
103042|NCT02218632|"~     Galactosaemia is an inherited condition caused by a lack of an enzyme (catalyst) which~     normally breaks down galactose (the sugar found in milk products). This affects 1:19,000~     births annually in Ireland (the highest incidence worldwide) and is screened for by the~     National Newborn Screening Programme. When an affected infant is diagnosed, galactose is~     immediately restricted from the diet. This prevents often fatal liver disease and other~     immediate complications. However, despite early treatment the majority of affected patients~     go on to develop long-term complications such as intellectual impairment, neurological~     complications, speech difficulties and infertility in females. The underlying mechanisms for~     these complications are unclear. The investigators have shown in detailed biochemical and~     gene analysis studies that major abnormalities affecting the function of complex molecules in~     the body, particularly glycoproteins, (consisting of sugar chains attached to proteins)~     persist in treated individuals which may lead to disturbances of the body's intrinsic~     cellular machinery and relate to the complications seen.~      In this research the investigators expand on from their earlier studies to see if they can~     identify biomarkers and parts of the galactose/glycosylation pathways which could be modified~     or changed with new treatments to improve outcomes for this condition (i.e., IgG N glycans).~      In more detail, the investigators test the use of the most abundant glycoprotein in human~     plasma (IgG) as an improved clinical test for monitoring the galactose control needed in~     patients and also to see if some patients (including children aged 5-12 yrs) might have a~     better predicted outcome with moderate increases of galactose in the diet. The investigators~     believe that these studies greatly improve the understanding of Galactosaemia with a view to~     improving current treatment options and future outcomes.~   "
125024|NCT01930994|"~     A cross-sectional study to compare pharmacokinetics of Sino-implant (II) during four years of~     used and Jadelle during five years of use by Kenyan women.~   "
103046|NCT02218580|"~     While there has been progress in juvenile idiopathic arthritis (JIA) management, there is no~     cure. Despite receiving standard of care, many children live with pain. Thus, it is not~     surprising that families turn to complementary and alternative medicines (CAM) therapies,~     including massage therapy (MT). Little is known about the efficacy of MT in JIA.~      In this project, a massage therapist will teach parents how to provide a massage to their~     child with JIA at bedtime, at home. The feasibility of establishing a home MT program for~     children with JIA will be evaluated. In addition, the effects of MT on JIA will be examined.~      This proposal is relevant to JIA families, who ask questions on MT to professionals of the~     JIA clinic.~      Beyond providing education to JIA families, this project demonstrates the team approach to~     JIA management. Team members will include a pediatric rheumatology nurse and a massage~     therapist.~   "
103047|NCT02218567|"~     The study hypothesis is that caregivers experience allows them to develop a lot of knowledge~     and know-how about behavioural problems in Huntington Disease and its consequences. The~     purpose of this study is to collect, describe and analyse caregivers experience in order to~     find and enhance their knowledge related to the adaptation to behavioural problems of~     Huntington Disease patients.~   "
103048|NCT02218554|"~     To evaluate the performance of the Micromedic BRONJ Risk Assessment in vitro assay (the~     BRONJ Assay) in identifying Multiple Myeloma (MM) and/or other cancer subjects at risk for~     developing Bisphosphonate-related Osteonecrosis of the Jaw (BRONJ) following intravenous (IV)~     administration of Bisphosphonates (BP).~   "
103049|NCT02218541|"~     The study will involve placing a dental implant through a guided surgery protocol developed~     using 3D CT technology. Because the implant position is planned digitally using the CT data~     from the patient, this allows investigation of an abutment that supports the implant crown~     and soft tissues to be fabricated prior to implant placement. In doing so, this makes the~     protocol for patient care simpler and faster. In fabricating the the abutment prior to~     surgery, the investigators will design the abutments at different heights below the gumline~     to see an optimal margin height for fabrication of the abutment prior to surgery. The study~     hypothesis is that more often the abutment margin placed just slightly below (.5mm) the~     gumline will be visible about half of the time while the abutment margin placed further under~     the gumline (1.5mm) will be visible only about 10% of the time. The optimal outcome is that~     at delivery and follow-up, the abutment margin will not show intraorally.~   "
103050|NCT02218528|"~     The study is designed to determine the extent to which a plant-based ingredient is able to~     modulate blood glucose response when administered with a meal.~   "
103051|NCT02218515|"~     The present study aimed to evaluate the effects of enamel matrix derivatives either alone or~     combined with autogenous bone graft applied to intrabony defects in chronic periodontitis~     patients on clinical/radiographic parameters and gingival crevicular fluid transforming~     growth factor-β1 level and, to compare with open flap debridement. Our hypothesis is to test~     whether the use of autogenous bone graft and enamel matrix derivative combination in the~     treatment of intrabony periodontal defects enhance the clinical, radiographic and biochemical~     parameters in comparison to the use of open flap debridement alone.~   "
103052|NCT02218502|"~     This study is performed to compare the diagnostic performance and cost-effectiveness of~     different diagnostic methods for differentiating benign from malignant adnexal (ovary or~     Fallopian tube) masses: the Risk of Malignancy Index (RMI) will be compared with a two-step~     triage test called simple ultrasound-based rules supplemented -if necessary- with either~     subjective assessment by an expert sonographer or Diffusion Weighted - Magnetic Resonance~     Imaging (DW-MRI). The investigators will test the hypothesis that this two-step triage test~     will have better diagnostic accuracy than the RMI and therefore will improve the management~     of women with adnexal masses.~   "
103053|NCT02218489|"~     The primary purpose of this study is to determine the efficacy and safety of KPI-121~     ophthalmic suspension compared to vehicle (placebo) in subjects with signs and symptoms of~     inflammatory meibomian gland disease.~   "
103054|NCT02218476|"~     The study will be performed on 50 APS (antiphospholipid Syndrome) patients, which will be~     randomized to receive either CoQ10 (200mg/day) or placebo for one month. Blood will be drawn~     at time 0 and at the end of the treatment. Studies will be conducted in plasma and purified~     leukocytes from APS. Design: 1) Study of endothelial function: 2) Analysis of changes~     operated on various prothrombotic/proinflammatory parameters and their associated~     intracellular signalling. 3) Analysis of mitochondrial ultra structure and activity;~     mitochondrial antioxidant system characterization; Expression levels and activity of~     transcription factors/proteins involved in oxidative stress (Foxo 3, NFkB, Nrf2),~     Quantification of CoQ10 (Coenzyme Q10). 4) Biomarkers of oxidative stress. 5) miRNAs~     microarrays, RT-PCR validation and correlation/association studies. 6) Induction of~     over-expression of miRNAs of interest; luciferase constructs. 7)Studies of methylation.~   "
103055|NCT02218463|"~     First-line treatment for labial adhesions in prepubertal girls has been topical estrogen.~     This study aims to evaluate an alternative and less costly option of treatment with~     potentially less side effects.~      Primary Hypothesis:~      There will be a difference in complete resolution of labial adhesions with topical estrogen~     with lateral traction as compared to an emollient with lateral traction.~   "
103056|NCT02218437|"~     Mesenchymal Stem Cells (MSC) is a non Hematopoietic Stem Cells (HSC) in adult bone marrow and~     takes part in the bone marrow microenvironment. The response rate of early treatment on~     Children's SAA application combined with anti-thymocyte globulin (ATG) (40-50 days after ATG~     treatment) is associated with long-term effect. The injection of Umbilical Cord Derived~     Mesenchymal Stem Cells combined with ATG improves the efficacy of children with SAA.~   "
103071|NCT02218242|"~     All patients undergoing video-assisted thoracoscopic (VATS) resection of lung cancer will~     receive standard therapy including lobectomy or sub-lobar resection and mediastinal lymph~     node dissection. After completion of the standard of care, intraoperative ultrasound will be~     used to evaluate lymph node stations for the presence of any missed lymph nodes with~     particular focus on lymph nodes which may appear pathologic on ultrasound evaluation. Data~     will be reviewed for rates of pathologic upstaging, and sensitivity and specificity of~     ultrasound as an additional diagnostic tool in the operating room will be evaluated. It is~     hypothesized that Intra-operative thoracoscopic ultrasound following standard video-assisted~     thoracoscopic (VATS) dissection will increase the rate of pathologically staged in N2 nodes~     in non-small cell lung cancer patients undergoing definitive surgical resection.~   "
103057|NCT02218424|"~     This study is a double-blind randomized controlled trial using intravenous magnesium versus~     placebo to determine if systemic magnesium can decrease postoperative pain in pediatric~     patients undergoing tonsillectomy.~      Participants will be in one of two arms. Those in Arm 1 will receive magnesium (30 mg/kg~     bolus followed by a 10mg/kg/hr infusion) while those in Arm 2 will receive an equal volume of~     normal saline bolus followed by infusion (placebo).~      The primary objective is to determine if systemic magnesium will decrease postoperative pain~     in patients undergoing tonsillectomy. The secondary objectives will determine if systemic~     magnesium administration is associated with a decrease in opioid-related side effects,~     decrease the incidence of emergence delirium, and improve postoperative functional recovery.~      The study hypothesis is that the use of intravenous magnesium will decrease postoperative~     pain, decrease opioid-related side effects, decrease the incidence of emergence delirium, and~     improve functional recovery in patients undergoing tonsillectomy.~   "
103058|NCT02218411|"~     The purpose of this study was to evaluate the effects of a video-supported group-based Otago~     exercise programme intervention on balance, mobility, physical performance and aerobic~     endurance in community-dwelling older adults 65+ years old.~   "
103059|NCT02218398|"~     Investigators developed a test to assess the bronchodilator effects in mechanically~     ventilated chronic obstructive pulmonary disease patients by comparing the change of airway~     resistance. No matter whether patients respond to bronchodilator or not, they are randomized~     assigned to bronchodilator 3-4 times per day group and no bronchodilator group. Then~     investigators could objectively decide whether individual patients need or benefit from~     bronchodilator administration.~   "
103060|NCT02218385|"~     The purpose of this study is to measure the performance characteristics for the collection,~     fixation and transportation of clinical nipple aspirate fluid (NAF) specimens of the ForeCYTE~     Breast Aspirator across 3 independent labs and the National Reference Laboratory for Breast~     Health (NRLBH). The study hypothesis is that each lab will have a specimen acceptability rate~     of at least 90%. If it is assumed that the true level of acceptability testing is~     approximately 96%, then the lower bound of a one-sided 95% confidence interval is expected to~     be at least 90%.~   "
103061|NCT02218372|"~     The purpose of this study is to investigate the clinical response to fidaxomicin oral~     suspension or tablets and vancomycin oral liquid or capsules in pediatric subjects with~     Clostridium difficile-associated diarrhea (CDAD). It will also investigate the~     recurrence/sustained clinical response to and safety of fidaxomicin and vancomycin, as well~     as acceptance of the fidaxomicin oral suspension formulation.~   "
103062|NCT02218359|"~     To demonstrate the safety and efficacy of adjunctive therapy with the Amikacin Fosfomycin~     Inhalation System (AFIS) versus aerosolized placebo in mechanically ventilated patients with~     Gram-negative and / or Gram-positive bacterial colonization.~   "
103063|NCT02218346|"~     AG-221 is a first-in-class drug targeted specifically to inhibit the IDH2 enzyme. Small~     molecule inhibition of the IDH enzyme represents a new, targeted approach to cancer~     treatment.~      Administration of oral drugs with food may change the absorption of drugs, and it is~     therefore useful to characterize the effect of food early in drug development.~   "
103064|NCT02218333|"~     The aim of the present study is to investigate effects of milk on body composition and muscle~     strength, inflammation, appetite, DNA damage/repair and PBMC whole genome transcriptomics in~     elderly subjects.~   "
103065|NCT02218320|"~     This is a Phase IV, open label, observational study to compare the gastrointestinal tissue~     concentrations, inflammatory response, and viral replication of two integrase-inhibitors,~     raltegravir and dolutegravir, in HIV-infected volunteers who are virologically suppressed in~     blood plasma. The study will be comprised of 20 HIV-infected volunteers who will be enrolled~     equally into two groups. Group A will consist of 10 subjects receiving an antiretroviral~     regimen of tenofovir, emtricitabine, and raltegravir, and Group B will consist of 10 subjects~     receiving an antiretroviral regimen of tenofovir, emtricitabine, and dolutegravir.~     Participants will provide small pieces of tissue, or biopsies, which will be taken from three~     distinct locations of the large intestine during a colonoscopy procedure. These biopsies will~     be used to measure the amount of raltegravir or dolutegravir, HIV virus, and inflammatory~     markers present in the gastrointestinal tract.~   "
103066|NCT02218307|"~     Double blind placebo controlled trial to evaluate whether the routine use of nasal irrigation~     with mupirocin is more effective than saline irrigations alone in reducing symptoms of~     chronic rhinosinusitis in the early postoperative period.~   "
103067|NCT02218294|"~     The purpose of the study is to assess the extent that radioactive dose of BCX4161 taken by~     mouth ends up in the urine, feces and expired air. If there are metabolites of BCX4161 made~     by the body, the chemical composition of these metabolites and their profile over time in~     blood and urine will be determined.~   "
103068|NCT02218281|"~     The recent Surgeon General's Report calls for effective and readily available treatment~     approaches to help adolescent smokers interested in quitting. Schools are an ideal venue for~     connecting adolescent smokers with smoking cessation assistance. This study will adapt the~     Craving to Quit (C2Q) smartphone app, which integrates mindfulness training into a smoking~     cessation program, for teen smokers (C2Q-Teen). We will test how well this novel app helps~     teens stop smoking compared to another teen smoking cessation app that does not include~     mindfulness training, and to written cessation information alone. If effective, the C2Q-Teen~     would be relatively easy to disseminate widely and have tremendous public health significance~   "
103069|NCT02218268|"~     Using radial artery tonometry to study arterial stiffness, the plan is to study a cohort of~     65 children with Type I diabetes mellitus. This prospective, crossover study will help~     determine if there is an acute increase in arterial stiffness in children with Type I~     diabetes mellitus who do not give extra insulin to cover a meal. This will give more support~     to show why it is so critical to bolus every time they eat and to bolus on time to decrease~     cardiovascular consequences of poorly controlled diabetes. The hypothesis is that giving~     insulin before a meal compared to not giving insulin before a meal will be associated with~     lower arterial stiffness in children with type I diabetes.~   "
103070|NCT02218255|"~     The purpose of this clinical investigation is to gather pilot data to evaluate the impact of~     using Eeva™, a time-lapse enabled embryo test, in combination with traditional morphology on~     clinical pregnancy rates.~   "
103073|NCT02218216|"~     This hypothesis-generating feasibility study to determine potential associations between a~     broad range of clinical neurological symptoms and Magnetic Resonance Image (MRI), data, and~     clinical findings involved in mild traumatic brain injury (mTBI). These associations will be~     examined over the acute and sub-acute period (baseline to 3 months) following injury to~     provide information useful for optimization of MR pulse sequences for mTBI applications.~      The intent of this study is to broadly generate a range of potential mTBI biomarkers~     detectable using investigational MR pulse sequence technologies. Feasibility data attained in~     this study may be used for engineering program decision-making and in support of future~     scientific assessment, engineering development, published research databases or registries~     mTBI data and images, and other purposes determined by the Sponsor. The results of this study~     are not intended for use in regulatory submissions.~      Subjects will be examined on commercially available MR scanner using investigational or~     standard of care MR coils and a series of investigational Application Packs containing a~     predetermined set of MR pulse sequences optimized by Sponsor~   "
103074|NCT02218203|"~     This randomized, placebo-controlled, double-blind 4x4 crossover clinical trial was part of a~     larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of~     chronic oral (PO) dextromethorphan and intravenous (IV) lidocaine in central neuropathic pain~     following spinal cord injury.~   "
103075|NCT02218190|"~     The purpose of the study is to determine with Alvimopan reduces the incidence of post~     operative ileus in patients who undergo posterior spinal fusion.~   "
103076|NCT02218177|"~     The purpose of this study is to evaluate the level of cytokines (which are small proteins~     important in cell signalling) in eye fluid (aqueous humour) in patients with wet age related~     macular degeneration patients who have been treated with an injection in the eye~     (intravitreal injection) with a drug called ranibizumab. The level of cytokines will be~     compared between patients who have a good response to ranibizumab treatment and patients who~     are non-responsive to ranibizumab and need other forms of therapy. This knowledge will help~     for the future treatment and to potentially develop new medication for wet age-related~     macular degeneration.~   "
103077|NCT02218164|"~     The purpose of this study is to find out if the combination of two established anti-cancer~     therapies are beneficial in patients with squamous cell carcinoma of the skin. Specifically,~     investigators want to determine if the combination of 5-FU/Capecitabine (oral pills) and~     Interferon alpha-2b (injection) can help people with advanced cases of squamous cell~     carcinoma of the skin. For participants that are not approved for oral capecitabine, treating~     physicians will use continuous infusion 5-FU. Both 5-FU/Capecitabine and Interferon alpha-2b~     have been used separately to treat squamous cell carcinoma of the skin and are FDA approved~     in other cancer types.~   "
103078|NCT02218151|"~     Hematopoietic stem cell transplantation (HCT) has the potential to cure a variety of~     malignant and non-malignant diseases. However, it is associated with significant morbidity,~     and treatment-related mortality. This is due in large part to the prolonged pancytopenia and~     immunosuppression associated with the preparatory regimen of chemotherapy and/or radiation~     and the wait until engraftment of the transplanted hematopoietic stem cells. During this~     vulnerable period, infectious complications are common. Historically HCT patients were kept~     in protected environments to safeguard their health during the pancytopenic phase; despite~     these measures, infectious complications and graft versus host disease (GVHD) remained common~     and lead to significant morbidity and mortality after HCT. Currently patients are still~     closely watched in the inpatient or day hospital environment, though recent practices allow~     patients more freedom. This study randomizes eligible patients to receive post-transplant~     care at home vs. in the hospital or clinic, per standard of care. The primary objective is to~     compare the incidence of grade II-IV acute GVHD at 6 months in patients receiving~     patient-centered medical home (PCMH) vs standard care.~   "
103079|NCT02218138|"~     Type 2 diabetes is a chronic disease that puts people at risk for major health problems like~     heart disease. Type 2 diabetes is the most common type of diabetes in adults. However, there~     has been a concerning rise in type 2 diabetes among teenagers. Diabetes develops through poor~     insulin sensitivity, meaning that insulin - an important chemical the body makes to keep~     blood sugar normal - isn't working properly. Type 2 diabetes can be prevented by improving~     insulin sensitivity. Stress is related to insulin sensitivity. Individuals who feel stressed~     have worse insulin sensitivity than individuals who do not feel stressed. In adults,~     decreasing stress leads to improvements in insulin sensitivity, but this hasn't been tested~     in teenagers. The purpose of this study is to find out if taking part in a brief group~     program to decrease stress will improve insulin sensitivity and lower diabetes risk in~     teenage girls.~   "
103080|NCT02218125|"~     The purpose of this study is to assess the safety and tolerability of Modified Vaccinia~     Ankara (MVA) Mosaic vaccine in healthy adult participants.~   "
103081|NCT02218112|"~     The sympathetic nervous (SNS) and the renin angiotensin aldosterone system (RAS) have a~     direct impact on renal hemodynamic, hormonal secretion and vasoactive peptide. Many~     mechanisms including the SNS, RAS and renal sodium handling could explain the pathogenesis of~     hypertension in obese patients. Lifestyle changes and bariatric surgery induce weight loss,~     which is associated with blood pressure lowering in obese patients. A diminution in the renal~     sympathetic stimulation and RAS activation could explain this effect.~      The AIM of this study is to show that weight loss induced by bypass surgery in obese patients~     affects renal salt excretion under  low body negative pressure (LBNP) conditions .~      Secondary objectives are to investigate the impact of weight loss on renal hemodynamic~     (glomerular filtration rate (GFR), renal plasma flow) and neurohormonal responses under  low~     body negative pressure conditions . We will also analyse renal blood oxygenation with Blood~     Oxygenation dependant IRM (BOLD-IRM) technique before and after weight loss.~      The population of this study will consist in two groups including 36 patients. The first one~     will include 24 obese patients that are going to undergo a bariatric surgery. The second one~     will include 12 obese patients without any weight loss associated surgery.~      Both group will undergo 3 investigation days. Each patient will have to undergo a screening~     visit that will provide dietary advice to ensure a standardized salt intake (120-180~     mmol/day) for the duration of the study. The first investigation will define baseline, the~     second and third day of investigation will take place after 3 month and 12 month after~     bariatric surgery for surgical patients or after baseline for patients without surgery. One~     to two weeks before phase 1 and 3 patients will perform a BOLD-MRI. The surgery group will~     undergo bariatric surgery between the first investigation phase (baseline) and the second. An~     ambulatory blood pressure and 24-hour urine collection will precede each investigation day.~     An investigation day consists in renal hemodynamics, neurohormonal and natriuretic response~     measurements before, during and after 60 min of LBNP at -30mbar . The duration of the study~     per subject is going to take 12 months.~   "
103082|NCT02218099|"~     This study consists of two parts. Part 1 evaluates the effect of renal impairment on the PK~     and PD of a single dose of ASP8232. In addition, the safety and tolerability will be~     assessed.~      Part 2 evaluates the PK, PD, and safety and tolerability of multiple doses of ASP8232~     compared with placebo in Type 2 Diabetes Mellitus (T2DM) subjects with Chronic Kidney Disease~     (CKD).~   "
103083|NCT02218086|"~     Slacklines have been established in the last few years as a training equipment in sports such~     as climbing, skiing and others to increase postural control. Furthermore, slacklines are used~     in physiotherapy in terms of stabilizing training such as wobbling boards.~      However, if slackline training is effective in rehabilitation has not been investigated yet.~     Therefore, to goal of this study will be to investigate the effectivity of slackline training~     in physiotherapy compared to a wobbling board with a single tilting axis.~      Outcomes will be electromyographic-data and the kinetics of the whole body.~   "
103084|NCT02218073|"~     The purpose of this study is to evaluate the absolute bioavailability (the extent to which a~     drug or other substance becomes available to the body) of JNJ-42756493 following a single 10~     milligram (mg) dose as an oral solution administered in combination with a single intravenous~     administration of a microdose (100 microgram [mcg]) of JNJ-61818549 and to evaluate the~     relative bioavailability of 10 mg JNJ-42756493 following an oral solution (reference) and a~     tablet (test) formulation in a crossover (method used to switch subjects from one study group~     to another in a clinical trial) design in healthy participants.~   "
103085|NCT02218060|"~     Coronary CT angiography is used to examine the coronary arteries in a non-invasive way when a~     patient is suspected of having coronary artery disease. The test, however, requires~     relatively high levels of radiation, which have been linked to DNA damage and cancer, and the~     use of contrast material, which can affect kidney function. The SOMATOM Force, a new~     third-generation CT scanner manufactured by Siemens, was recently installed at MUSC and holds~     the potential to obtain quality images while also reducing radiation dose and contrast~     material. This study aims to test the diagnostic ability of the SOMATOM Force in detecting~     coronary artery disease and also see if radiation dose and contrast material are reduced~     compared to the previous 2nd generation scanners. It is suspected that the Force will provide~     clinical quality images while decreasing radiation dose and contrast material required.~   "
103086|NCT02218047|"~     Polycythemia Vera (PV) is a disease of bone marrow stem cells that manifests in a drastic~     increase of red blood cells and frequently also of white blood cells. The thickening of the~     blood in relation with a modified function of the cells has several consequences like~     increased blood pressure, pruritus of the skin, fatigue, disturbed blood circulation in the~     brain as well as fingers and toes and an increased risk of arterial and venous thrombosis~     (thrombosis is the formation of a blood clot in a vessel); like stroke, cardiac infarction,~     deep vein thrombosis in the legs. In case of a strong increase of platelets there is an~     additional risk of bleedings. As the disease progresses the size of spleen and liver~     increased in most cases and the bone marrow shows signs of fibrosis. In some cases of PV a~     progression at a later time point to a leukemia (increased formation of white blood cells)~     can occur.~      The aim of this study is to show that the study drug AOP2014 (pegylated proline interferon~     alpha-2b) has the long term efficacy and safety in controlling the disease. A comparison arm~     is receiving best available therapy as selected by the investigator. Response to the~     treatment is measured by several blood parameters as well as size of the spleen.~      Interferon-alpha has been shown to be effective in controlling the blood parameters by~     immunologically influencing the blood building cells. This can lead to a suppression of the~     disease-causing stem cells and help healthy stem cells to proliferate. Through this mechanism~     it is possible that Interferon-alpha can avoid long-term damaging effects of the disease.~   "
103087|NCT02218034|"~     This is a safety, tolerability and pharmacokinetics study of AGN-190168 in subjects with acne~     vulgaris.~   "
103088|NCT02218021|"~     The purpose of this study is to evaluate the abuse potential and safety of samidorphan in~     healthy, non-dependent, adult, recreational opioid users.~   "
103089|NCT02218008|"~     This study will evaluate the efficacy and safety of ALKS 5461.~   "
103090|NCT02217995|"~     Obsessive Compulsive Disorder (OCD) is a chronic and debilitating disorder known to have~     reported lifetime prevalence in the range of 2%. OCD is most commonly treated with Cognitive~     Behavioural Therapy (CBT) and/or pharmacotherapy. However, some studies suggest challenges~     with CBT in retaining gains long term, and while 60-80% of OCD patients respond to SRI~     treatment, partial symptom reduction is substantial. Investigations into the effectiveness of~     alternative, cost-effective treatment modalities are thus needed. Mindfulness, defined as~     paying attention in a particular way (on purpose, in the present moment and nonjudgmentally),~     promotes awareness and attention to internal experience and has been shown to reduce symptoms~     of anxiety and depression. A number of controlled studies have found Mindfulness-Based~     Cognitive Therapy (MBCT) to be effective for depression, social anxiety disorder, and~     generalized anxiety disorder, but few have tested its effect on obsessive compulsive disorder~     (OCD). Moreover, those studies examining MBCT in OCD focused on clinical case studies and~     non-clinical samples. This study proposes to examine the effect of MBCT in clinical practice,~     in a randomized sample of patients with OCD whom are on a clinic wait list. As patients are~     allocated to the wait list, they will be randomly assigned to receive either 10 weeks of~     group MBCT or wait list as per usual. It is hypothesized that subjects randomly assigned to~     the MBCT treatment group, compared to those in the wait list control group, will see greater~     reductions in self-reported measures of OCD symptom severity and improvement in other~     measures of mindfulness, mood and level of functioning. The results of this pilot study, if~     successful, will provide evidence towards another route by which patients can improve their~     OCD while waiting for clinic services or consultation. Results will also lend more evidence~     as to whether MBCT is effective as a stand-alone treatment for clinical OCD, which will~     inform further investigations into the potential addition of mindfulness techniques to~     standard care.~   "
103091|NCT02217982|"~     Single site, open label, randomized design in patients with relapsing forms of Multiple~     Sclerosis. At the Screening Visit, the patient will be given a diary containing the MAGIS~     scale to be completed once a day for the first two weeks while on Dimethyl Fumarate (DMF),~     including the titration period.~      After two weeks or if a patient experiences 3 or more consecutive days of GI symptoms in any~     category of ≥3.5, the patient will return for a Baseline Visit. The MAGIS diary will be~     reviewed by the coordinator. Any patient who has reported an average MAGIS score of greater~     than or equal to 3.5 in at least one of the key categories will be randomized to a standard~     therapy or treatment arm. Patients who report a MAGIS of less than 3.5 during this period~     will be terminated from the study at this visit. Patients with an average reported MAGIS of~     greater than 6.5 at Baseline will be placed in the treatment arm.~      Patients who are randomized to the treatment arm will be instructed to take 125 mg~     simethicone and one tablespoon of a high fat food (peanut butter) 10 minutes prior to each~     DMF dose. If the average MAGIS score is greater than 3.5 in the diarrhea category they will~     also be instructed to take 2 mg loperamide three times daily.~      Patients randomized to the standard therapy arm will be instructed to follow the normal~     dosing regimen for DMF with a food bolus of their choice prior to dosing. If severe symptoms~     (MAGIS >6.5) are noted at any time post randomization in any MAGIS category, crossover to the~     treatment arm will be allowed. Both groups will be asked to rate their GI symptoms over the~     past 24 hours using the MAGIS scale once daily.~      Both treatment arms will be observed for 6 weeks. MAGIS will be recorded once daily. Patients~     will return to the clinic at Week 3 and Week 6/End of Treatment for diary and compliance~     review. After Week 6, patients will be instructed to return to a standard therapy. MAGIS will~     be recorded for one more week and collected at Week 7/End of Study.~   "
103092|NCT02217969|"~     Patients undergoing anesthesia for non-cardiac surgery will be randomized to either having~     their anesthesia team alerted or kept blinded to extended periods of less than normal blood~     pressure with the goal of studying if providing these alerts leads to improved outcome after~     surgery (lower risk of death or complication in the days and weeks following surgery).~   "
103096|NCT02217917|"~     This is a 2 part study designed to provide an initial assessment on the safety, tolerability,~     and PK of rivipansel, following single ascending (Part 1) and multiple ascending dosing (Part~     2) given subcutaneously with rHuPH20, in healthy subjects. Part 1 of the study will be~     conducted using a cross-over design while Part 2 of the study will be conducted using a~     parallel design.~   "
103097|NCT02217904|"~     This study will evaluate the safety, tolerability, pharmacokinetics, and anti-retroviral~     therapy (ART) activity of MK-8591 monotherapy in ART-naive, human immunodeficiency virus-1~     (HIV-1) infected participants. The primary hypothesis is that at a safe and tolerable dose of~     MK-8591, the true mean difference in the plasma HIV-1 ribonucleic acid (RNA) reduction from~     baseline between MK-8591 and placebo is at least 0.5 log (base10) copies/mL.~   "
103098|NCT02217891|"~     The proposed study, IFACT - Incidental Findings in Advanced Cancer Therapy, will address this~     research gap by examining MSK patients' attitudes, preferences, and information needs~     regarding incidental findings arising from tumor genomic profiling.~   "
103099|NCT02217878|"~     The purpose of the IMPRESSION study is to determine whether intravenous administration of~     morphine prior to ticagrelor administration in ST-segment elevation myocardial infarction~     (STEMI) patients and in non-ST-segment elevation myocardial infarction (NSTEMI) patients~     alters the plasma concentrations of ticagrelor and its active metabolite and whether it is~     associated with any negative impact on the antiplatelet effect of ticagrelor.~   "
103100|NCT02217865|"~     The long-term goal of this research is to develop new tools to guide patients, caregivers,~     and clinicians in making individualized decisions regarding colorectal cancer (CRC)~     surveillance. As part of a Patient-Centered Outcomes Research Institute-funded contract,~     investigator will analyze surveillance data to determine the effectiveness of CRC~     surveillance and recurrence risk taking into account different patient and tumor~     characteristics; identify key issues about CRC surveillance important to patients,~     caregivers, and clinicians; and integrate the recurrence risk and patient priorities into a~     patient-centered, risk stratified surveillance strategy by creating an interactive decision~     aid for use by patients and clinicians.~      This protocol addresses a formative step in the creation of the interactive decision aid~     where patients' information needs and preferences are assessed regarding decisions about~     surveillance.~      The specific aims of this protocol are:~      Phase 1 - To interview patients and their caregivers to determine their concerns, preferences~     and key priorities regarding surveillance after curative resection of colorectal cancer, and~      Phase 2 - To refine the key priorities identified in phase 1 through focus groups and surveys~     with patients and caregivers.~   "
103101|NCT02217852|"~     Several surveys had revealed that Tibetan adults had high prevalence of hypertension.~     However, there was no research studying the antihypertensive effect of the known drugs in~     Tibetan. The main arms of our study were to determine if the efficacy of lowing blood~     pressure and protecting target organ damage differs between nitrendipine and~     Hydrochlorothiazide in mild hypertension in Tibetan, and to determine if the efficacy of~     lowing blood pressure and protecting target organ damage differs between captopril plus~     Hydrochlorothiazide and Beijing hypotensive No.0 in moderate and severe Tibetan hypertension.~   "
103102|NCT02217839|"~     This multi-ascending dose study is designed to investigate the safety, tolerability,~     pharmacokinetic and side effect profile of multiple ascending doses of DG3173, in up to 48~     healthy volunteers.~   "
103103|NCT02217826|"~     In this single-dose, randomized, 5-way cross-over study, healthy volunteers were treated with~     the highest approved dose of octreotide, three different doses of Somatoprim (DG3173) and~     placebo control. The main purpose of the study was to investigate the effects of each~     treatment on the control of plasma glucose as well as the secretion of insulin and glucagon~     following a standard meal.~   "
103104|NCT02217813|"~     Each subject will be given tafamidis. After swallowing a single tafamidis capsule, tafamidis~     blood concentrations will be measured periodically for one week. After about 20 days,~     subjects will take a different form of tafamidis capsule and the process repeated. Tafamidis~     concentrations from the two different formulations will be compared to determine if they are~     approximately the same.~   "
103105|NCT02217800|"~     This study is designed to assess the effect of the different continuous s.c. infusion~     treatments on the human growth hormone (hGH) levels in untreated acromegalic patients in~     comparison to a standard dose of octreotide. In addition, the pharmacokinetic profile and the~     safety and tolerability of DG3173 after continuous s.c. infusion will be evaluated.~   "
103106|NCT02217787|"~     This study has been designed to investigate the effect of high fat food on the~     pharmacokinetics of PF-06372865 when administered to healthy subjects as single oral doses.~   "
103107|NCT02217774|"~     The aim of the present study is to assess the accuracy of MGUIDE MORE System (MGS),~     consisting of MGUIDE MORE software, MGUIDE MORE surgical kit and MGUIDE MORE template by~     evaluating the difference between planned and actual implant positions on pre- and~     post-operative CBCTs.~   "
103108|NCT02217761|"~     The purpose of this study is to investigate the factors influencing pharmacokinetic and~     pharmacodynamic properties of new antifungal agent, posaconazole in Taiwanese patients.~   "
103109|NCT02217748|"~     The objective of our study was to determine the extent to which the order of specific items~     in a multiple name generator survey affects how social networks are measured.~   "
103110|NCT02217735|"~     This randomized, controlled trial (RCT) evaluates the benefits of expressive compared to~     neutral writing in individuals with Parkinson's Disease and their support persons.~     Participants will be randomly assigned to complete three, 20 minute sessions of expressive or~     neutral writing. Participants will complete evaluation of outcomes at baseline, immediate~     post, 4 month and 10 month follow ups to establish if benefits remain over time. Impact of~     these therapies on thinking abilities, physical health, and patient and support person~     ratings of thinking skills, mood and quality of life will be evaluated. Expressive writing is~     hypothesized to result in greater improvements and/or stability of function on~     neuropsychological tests of attention, working memory, learning, and memory skills compared~     to the neutral writing condition.~      Results from this study will determine whether brief writing exercises are easily used by and~     beneficial for individuals with Parkinson's Disease and their support persons. If positive~     benefit is observed, information from this study will be used to further optimize these~     therapies for larger trials designed to evaluate the value of the therapies for individuals~     with Parkinson's Disease and their support persons.~   "
103111|NCT02217722|"~     The goal of the study is to evaluate the use of Ulcerative Colitis Diet for Induction of~     Remission. The investigators have postulated that we developed could be beneficial for~     patients with Ulcerative Colitis. To date, no study has explored this possibility.~   "
103112|NCT02217709|"~     This phase II trial studies phenelzine sulfate in treating patients with prostate cancer that~     has not spread to other parts of the body and has come back. Phenelzine sulfate is a type of~     antidepressant that works by decreasing the amount of a protein called monoamine oxidase~     (MAO). MAO drugs may have an anticancer effect in prostate cancer.~   "
103113|NCT02217696|"~     The long-term goal of this study is to improve prediction of poor reading outcome at~     preschool age by using a combination of behavioural and neuroimaging measures and to evaluate~     a specific computerized training program to support children with problems during reading~     acquisition.~   "
103114|NCT02217683|"~     The objective of this study is to assess if prolonged storage time of a packed red blood cell~     unit may cause pulmonary vasoconstriction after transfusion, in a susceptible population such~     as cardiac surgery patients. The investigators will also evaluate the potential reversal~     effect of Inhaled Nitric Oxide on pulmonary vasoconstriction induced by stored blood~     transfusions.~   "
103115|NCT02217670|"~     The main purpose of this study is to assess comparative bioavailability of a test formulation~     of Metformin HCl 1000 mg granules manufactured by Indeus Life Sciences Pvt. Ltd., Mumbai~     India (An Affiliate Of Disphar International B.V., The Netherlands) relative to Glucophage~     1000 mg film-coated tablets of Merck GmbH, Austria in 54 healthy adult subjects under fed~     conditions. The second aim is to asses the safety of subjects and to determine other~     pharmacokinetic data.~   "
103116|NCT02217657|"~     This prospective, randomized study will investigate, if information of the catheter force~     during ablation of a left anterior line does reduce total RF application time by prevention~     of ineffective lesions.~   "
103117|NCT02217644|"~     -  Investigation of safety and tolerability of BI 653048 H3PO4 following the administration~          of single rising doses of an aqueous solution in healthy male subjects~        -  Pharmacokinetic and pharmacodynamic characteristics of BI 653048, including the~          investigation of dose proportionality~        -  Investigation of relative bioavailability of capsules versus aqueous solution~   "
103118|NCT02217631|"~     The objectives of the trial were to assess safety, tolerability, pharmacokinetics, and~     pharmacodynamics of multiple rising doses of BI 653048 BS H3PO4 compared with prednisolone.~   "
103119|NCT02217618|"~     The study involves a single dose of LY2409021 taken by mouth. The purpose of this study is to~     determine how much LY2409021 enters the bloodstream and how long the body takes to get rid of~     the drug after the dose. This study will last approximately 28 days, not including screening.~     Screening can occur within 30 days prior to the start of the study.~   "
103120|NCT02217605|"~     The purpose of this study is to determine the effects of an oral fructose challenge on liver~     adenosine triphosphate (ATP) reserves using 31P magnetic resonance spectroscopy (MRS) as a~     potential measure measure of liver health.~   "
103121|NCT02217592|"~     This is an observational study to identify the aetiology and factors associated with outcome~     of community-acquired sepsis and severe sepsis in Northeast Thailand.~      Potential study participants will be adult patients who are presented at the hospital with~     community-acquired sepsis. Clinical specimens (including blood, urine, sputum and throat~     swabs) will be collected from each participant on admission for culture, PCR and serological~     tests, and other laboratory tests, including inflammatory markers and genotyping.~     Participants' treatment will be closely monitored during the duration of their hospital stay.~     Blood will be again collected at 72 hours after admission. Participants will be contacted at~     28 days after admission to determine clinical outcome by phone interview with standardized~     script.~      There will be a total of 5,020 patients enrolled in this study over 3 years.~   "
103122|NCT02217579|"~     The metabolic syndrome is rising worldwide as a consequence of the continued obesity~     epidemic. The current obesogenic environment makes the regulation of energy intake difficult~     and impedes the maintenance of weight loss. Dietary patterns and/or ingredients that curb~     hunger and reduce energy intake are critically needed. We hypothesize that inclusion of~     protein and prebiotic fiber in the diet will reduce adiposity in overweight and obesity~     adults.~   "
103123|NCT02217566|"~     The purpose of this study is to evaluate the efficacy, based on prostate-specific antigen~     (PSA) progression, of abiraterone acetate in participants with metastatic (spread of cancer~     cells from one part of the body to another) castration (any action, surgical, chemical, or~     otherwise, by which a male loses the functions of the testes) resistant prostate cancer~     (cancer in prostrate; a gland that makes fluid that aids movement of sperm) (mCRPC),~     chemo-naive (treatment of cancer is not done using drugs), who received a prior~     diethylstilbestrol therapy (DES).~   "
103124|NCT02217553|"~     Platelets play pivotal role in atherosclerosis and acute cardiovascular events. Platelet~     hyperreactivity and increase platelet-monocyte aggregate (PMA) formation are found in HIV~     infected patients, which may contribute to the excess cardiovascular risk. Low level of~     vitamin D has been associated with the presence of cardiovascular diseases. The aim of our~     study is to determine the effect of vitamin D supplementation on platelet activation,~     platelet reactivity and platelet-leukocyte complex formation in asymptomatic HIV-infected~     patients treated with ART~   "
103125|NCT02217540|"~     Objective: To pilot the methods proposed for conducting a full randomised clinical trial to~     evaluate the effect of Mulligan concept mobilization with movement on shoulder functionality~     in older adults with shoulder dysfunction.~      Design: Pilot randomised, single-blinded clinical trial. Setting: Three nursing homes,~     Toledo, Spain. Participants: 44 older adults with shoulder dysfunction. Interventions:~     Participants will be randomly allocated into control group (n=22) treated with a~     physiotherapy standard protocol proposed by the Spanish Rheumatology Society; and~     experimental group (n=22) treated with the same physical therapy standard protocol and~     Mulligan concept mobilisation with movement. Both interventions will take place three times a~     week for 2 consecutive weeks.~      Main outcomes: Primary outcome is shoulder functionality measured with Shoulder Disability~     Questionnaire (S-SDQ) Spanish version, and secondary outcomes are active glenohumeral range~     of motion and pain intensity. Data will be collected at baseline, after each group~     intervention, and 1 and 3 months after finishing interventions.~   "
103126|NCT02217527|"~     The study will assess a novel active drug vs. placebo on ability to reduce smoking and aid~     cessation during a one-week practice quit period for each condition in smokers with a high~     interest in quitting (i.e. crossover design). Medication effects on reducing craving,~     withdrawal, and cognitive impairment will help assess the mechanism to support quit smoking~     attempts.~   "
103127|NCT02217514|"~     Evaluation of the long-term (48 h) and short-term (1 h) effects of BI 44370 BS on the~     pharmacokinetics of midazolam as marker of a possible inhibition of CYP 3A4; safety and~     tolerability.~   "
103128|NCT02217501|"~     The purpose of this study is to evaluate whether clopidogrel 75 mg daily on a background of~     aspirin 75-100 mg/d for clinically indicated duration or for an additional 12 months will~     lead to an increased rate of primary patency, limb salvage, non-fatal myocardial infarction~     (MI), ischemic stroke, and survival, in patients receiving endovascular treatment of PAD at~     end of study treatment.~   "
103129|NCT02217488|"~     This clinical trial investigated the safety, tolerability and pharmacokinetic profile of~     DG3173 in a double-blind, randomized, placebo-controlled, single dose escalation Phase 1~     study involving 72 healthy volunteers. Individuals received up to 2000 µg of DG3173 via~     single dose subcutaneous injection.~   "
103130|NCT02217475|"~     The purpose of this study is to determine whether Cenicriviroc is effective and safe in the~     treatment of nonalcoholic steatohepatitis (NASH) in adult subjects with liver fibrosis.~   "
103131|NCT02217462|"~     The primary purpose of this observational cohort study is to examine the role of food~     reward in maternal diet and weight change during pregnancy and postpartum. The study will~     further examine the importance of food reward in the context of behavioral control and other~     related aspects of eating behavior, as well as weight-related biomedical, psychosocial and~     behavioral factors including genetics, physical activity, stress, sleep and depression. Four~     hundred and fifty women of varying baseline weight status will be enrolled early in pregnancy~     (before 12 weeks postpartum) and followed until 1 year postpartum. Assessments will occur at~     baseline (<12 weeks postpartum), during pregnancy at 13-18 weeks gestation, 16-22 weeks, and~     28-32 weeks, and postpartum at 4-6 weeks, 6 months, 9 months and 12 months. Measures will~     include assessments of food reward and related constructs, dietary intake, other health~     behaviors, and anthropometrics. Clinical data and biological specimens will be obtained.~     Infant anthropometrics and feeding practices will also be assessed. Primary exposures include~     aspects of food reward and behavioral control, which will be assessed in multiple ways to~     maximize information and utility. Primary outcomes include gestational weight gain,~     postpartum weight retention and dietary quality.~   "
103132|NCT02217449|"~     To assess the accuracy of predicting histology with virtual chromoendoscopy for distal~     colorectal polyps according to the ASGE PIVI statement.~   "
103133|NCT02217436|"~     Children aged 2-12 presenting to the Rady Children's Hospital San Diego (RCHSD) emergency~     department with facial lacerations requiring suture repair will be eligible to participate in~     the study. Participating children will be randomized to standard care versus standard care~     plus iPad use during the procedure. Children's anxiety levels assessed using a validated~     scale will be measured from video recordings made of the procedure. Parent and provider~     satisfaction surveys will be completed following the procedure. The primary study aim is to~     determine how iPad use affects children's anxiety levels during facial laceration repair. The~     secondary study aim is to determine how iPad use affects parent and provider satisfaction~     regarding a child's facial laceration repair. Hypothesis is that iPad use decreases~     children's anxiety levels during facial laceration repair and increases parent and provider~     satisfaction regarding a child's facial laceration repair.~   "
103134|NCT02217423|"~     The purpose of this study is to determine whether the hospitalized patients with increased~     waist circumference exhibit cardiorespiratory alterations after chest physical therapy.~   "
103135|NCT02217410|"~     The purpose of this study is to investigate the safety, tolerability, pharmacokinetics (PK)~     and potential for CFZ533 to replace calcineurin inhibitors (CNI), while providing a similar~     rate of acute rejection prophylaxis and renal function in a de novo renal transplant~     population receiving an allograft from standard criteria donors.~   "
103136|NCT02217397|"~     Obstructive sleep apnea (OSA) is a situation of repetitive upper airway obstruction during~     sleep. For patients with severe OSA, continuous positive airway pressure (CPAP) therapy was~     the standard therapy, especially those with daytime sleepiness and cardiovascular~     comorbidities. Although CPAP is effective in OSA treatment, the poor adherence due to high~     pressure was often reported. Instead, oral appliance (OA) was the alternative for those who~     could not tolerance CPAP or mild to moderate OSA. Oral appliance was less effective in~     compared with CPAP, but OA is more tolerable and acceptable in OSA patients.~      Only one observation study addressed the effects of the combinations of OA and CPAP in OSA~     patients . The pilot study displayed combination therapy of CPAP and OA is effective in OSA~     patients and could decrease CPAP pressure. However, the study enrolled the patients with CPAP~     intolerance according to the subjective chief complaint, not the objective CPAP pressure~     data. In the present study, we studied the effects of combinations of CPAP and OA for~     patients with severe OSA who could not tolerate CPAP with high-pressure setting.~   "
103137|NCT02217384|"~     Background. Anorexia nervosa (AN) still carries the highest fatality rate of any psychiatric~     disease, and less than half of the patients recover, completely refractory to any treatment.~     The etiology remains unknown and evidence for treatment is lacking. The intestinal microbiota~     and its microbiome provide humans with additional gene products which may be regarded as an~     organ, which contributes to multiple host metabolic pathways. Recent advances in microbial~     DNA sequencing technologies have resulted in metagenomic DNA analysis of whole ecosystems~     such as the human gut. Altered intestinal microbiota has been related to obesity and insulin~     resistance. Hypothetically, the intestinal microbiota could play a role in the generation~     and/or maintenance of the emaciation in AN.~      Aim. The aim of the present study is to investigate whether gut microbiota is altered in~     patients with AN.~      Subjects and methods. A cross sectional study of the gut microbiome profiles in 75 clinical,~     psychometric and biochemical well characterized treatment seeking females with AN. The~     microbiome profiles are compared with 75 age- matched healthy Danish control subjects.~      Perspectives. Clarifying whether the intestinal flora is implicated in the susceptibility to~     or maintenance of AN may provide the basis for development of new highly required treatments.~   "
103138|NCT02217371|"~     In a previous protocol, we highlighted an excessive daytime sleepiness at the Maintenance of~     Wakefulness Tests (MWT) in 36% of adult Attention Deficit Disorder with or without~     Hyperactivity (ADHD) patients. In 40% of cases this sleepiness was associated with a sleep~     disorder objectified by polysomnography (PSG): apnea hypopnea syndrome (AHI) ≥ 10/h and / or~     Periodicals Movements of Lower Limb (PLMI) ≥ 15/h. However, among patients with no sleep~     disorder PSG, we can question the central origin of the Excessive Daytime Sleepiness. Thus,~     we wish to determine potential changes in the regulation of sleep / wake cycle through a~     protocol of extended wake.~      The principal objective is to compare the objective sleepiness in sleepy patients with ADHD~     and healthy subjects during a protocol of extended wake.~      It's an observational study of interventional type realized in patient with ADHD syndrome~     deprived of psychostimulant treatment (for 72 hours) and healthy subject, investigating the~     implication of the homeostatic and circadian systems in the preservation of awakening.~   "
103139|NCT02217358|"~     The aim of the project is to compare NBI endoscopy and standard endoscopic method using white~     light and evaluate accuracy both methods in early detection and diagnosis hypopharyngeal and~     laryngeal precancerous and cancerous lesions. A higher contrast between the mucosal~     epithelium and blood vessels is achieved in NBI endoscopy using filtered light comparing to~     white light observations. This allows detection of small mucosal changes, few millimetres in~     diameter, which are not observable using white light. The second aim in patients with~     squamous cell carcinoma of the upper aerodigestive tract is to compare extension of mucosal~     lesions by evaluation of NBI endoscopy and white light endoscopy, which is crucial for~     perform targeted biopsy and for determination of resection margins in cancer surgery. The~     investigators expect that dysplastic changes of mucosa or early laryngeal cancerous lesions~     are detected in white light endoscopy rarely. In case our hypothesis is confirmed, frequency~     of precancerous and early cancerous lesions of hypopharynx and larynx is more common in~     patients with non-specific symptoms of laryngeal and pharyngeal diseases.~   "
103140|NCT02217345|"~     Nonalcoholic fatty liver disease (NAFLD), fatty infiltration of the liver in the absence of~     alcohol use, is an increasingly recognized complication of obesity, with prevalence estimates~     of about 30% of individuals in the United States. A subset of these will develop progressive~     disease in the form of nonalcoholic steatohepatitis (NASH), which can progress to cirrhosis~     and liver failure. NAFLD is expected to be the most common indication for liver~     transplantation by the year 2020. We hypothesize that growth hormone (GH) replacement will~     decrease intrahepatic lipid accumulation as quantified by 1H magnetic resonance spectroscopy~     (1H-MRS).~   "
103141|NCT02217332|"~     Phase 2, open-label, multi-center study to evaluate the clinical effects of oral~     administration of dexpramipexole for 6 months in subjects with chronic sinusitis with nasal~     polyps and eosinophilia.~   "
103142|NCT02217319|"~     It has been shown that the use of volatile anaesthetics, that are usually used to perform a~     general anesthesia, have cardioprotective properties. This has been shown in animal studies~     and in patients that underwent cardiac surgery. The aim of our study is to examine if~     Sevoflurane, a volatile anaesthetic, has this properties in patients undergoing lung surgery.~   "
103143|NCT02217306|"~     Contrast sensitivity is a tool use to evaluate the visual function in all patients. It can be~     modified by different pathologies or by age. The purpose of this study is to identify the~     changes that could be in relationship with the course of diabetic retinopathy comparing with~     diabetic patient without retinopathy and in patients with diabetic macular edema so if it is~     a difference, research for therapeutic strategies to improve it in this patients.~   "
103144|NCT02217293|"~     Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy. Although~     many conservative forms of management including the use of wrist splint, steroid injections~     and therapeutic ultrasound are applicable, their effectiveness is typically insignificant or~     short-lived.~      Pulsed radiofrequency (PRF) treatment, a relative novel pain intervention at recent decade,~     was found to be able to alleviate pain for certain kinds of chronic pain conditions without~     damaging nerve. However, the application of PRF in CTS is scarce.~      The purpose of this study was to assess the analgesic effect and prognosis of~     ultrasound-guided PRF in the median nerve in patients with CTS.~   "
103145|NCT02217280|"~     This study will analyze injectate dispersal patterns after standard-of-care cervical epidural~     steroid injections using gadolinium as a marker and magnetic resonance imaging (MRI) to~     characterize the pattern. Although these procedures are performed with high frequency under~     the assumption that injectate remains localized to injection site, no peer-reviewed studies~     have validated this assumption. Comprehensive characterization of injectate dispersal~     patterns will provide important data regarding safety, as well as diagnostic and therapeutic~     potential of cervical epidural steroid injections.~   "
103146|NCT02217267|"~     The purpose of this study to evaluated Long term outcome after serial Lidocaine infusion when~     compared with placebo in peripheral neuropathic pain patients in acute stage (less than 6~     months) at 3 months after first time of infusion~   "
103147|NCT02217254|"~     It is an unproven assumption that at least 2 cryoablations is necessary in each pulmonary~     vein for successful ablation of atrial fibrillation. The investigators hypothesize that a~     single cryoablation in each pulmonary vein that achieves isolation may leads to equivalent~     efficacy with decreased risk. The One Freeze Study evaluates this hypothesis.~      This study compares one 3-minute cryoablation per pulmonary vein versus two 3-minute~     cryoablations per pulmonary vein during atrial fibrillation ablation procedures.~   "
103148|NCT02217241|"~     The purpose of this study is to assess the effectiveness of an educational intervention on~     handoffs implemented during the third year of medical school. It also assesses whether these~     skills are maintained over time into their fourth year of training and whether there is~     transfer from the simulated setting into the clinical environment.~   "
103149|NCT02217228|"~     Prospective, randomized multicenter study to examine the safety and effectiveness of Sebacia~     microparticles with or without laser in the treatment of moderate to moderately-severe~     inflammatory acne vulgaris~   "
103150|NCT02217215|"~     The purpose of this study is to evaluate whether fluorescence and reflectance spectroscopy~     can improve the ability to detect the presence of premalignant lesions on the cervix.~   "
104838|NCT02195115|"~     The goal of this study is to challenge the existing clinical practice of employing~     laparoscopic cholecystectomy as the treatment for gallbladder dyskinesia by comparing it to a~     regimen of active non-surgical therapy.~   "
103151|NCT02217202|"~     The aim of the study is to determine whether the AQUACEL™ Ag SURGICAL cover dressing is~     successful in reducing the incidence of wound infection in high risk patients following total~     knee replacement. We will also look at the status of the wound, occurrence of blistering,~     biochemistry results, dressing wear time and the number of dressing changes to quantify the~     dressing performance.~   "
103152|NCT02217189|"~     Although several studies have considered the relationship between infertility and semen super~     oxide radical scavengers levels, no study on the effects of asthenospermia treatments such as~     oral zinc supplementation on superoxide radical scavengers activity which are important in~     fertility of the individual has been reported.~   "
103153|NCT02217176|"~     Internal jugular venous catheterization is a challenging procedure in pediatric patients due~     to small size. Overlapping of the internal jugular vein (IJV) and common carotid artery (CCA)~     may jeopardize the success and increase the complication rate.However, the use of ultrasound~     as an assistance tool might be helpful to identify the relationship between the IJV and the~     CCA. Endotracheal intubation and insertion of laryngeal mask are the common options for the~     airway management during general anesthesia for central venous catheterization. In this~     observational study, the investigators aimed to investigate the impact of the laryngeal mask~     insertion or endotracheal intubation and the role of head rotation on the overlap of the IJV~     and CCA evaluated with ultrasound in pediatric patients undergoing any kind of surgical~     procedure.~   "
103154|NCT02217163|"~     Patients with high risk multiple myeloma have shorter remission periods and reduced overall~     survival. Prognostic significance of minimal residual disease negative remission is being~     highlighted in many of the newer studies.~      The current phase 2 study investigates the combination of carfilzomib together with~     cyclophosphamide and dexamethasone in patients with high risk multiple myeloma in younger~     transplantation eligible patients.~   "
103155|NCT02217150|"~     Prospective clinical series to gather post tumor ablation clinical outcomes from subjects~     with painful spinal metastases following targeted radiofrequency ablation (t-RFA) treatment~     with the STAR™ Tumor Ablation System.~   "
103156|NCT02217137|"~     Rheumatoid Arthritis (RA) and Systemic Lupus Erythematosus (SLE) are chronic systemic~     autoimmune diseases that have been reported to affect the ocular surface of patients [1,2].~     However, the nature of the disturbances of the ocular surface immunity and their relationship~     to systemic disease severity are poorly understood.~      This study aims to profile the ocular surface inflammation of RA and SLE patients by a.,~     analysing levels of tear cytokine, and b., investigating conjunctival cells, and c. clinical~     imaging for conjunctival redness and tear stability.~      20 consecutive RA patients and 20 consecutive SLE patients will be recruited from the~     Singapore General Hospital Rheumatology clinic. 20 age matched controls for SLE and another~     20 age matched controls for RA will be recruited.~      All participants will undergo~        1. Tear collection with Schirmer strips~        2. EyePRIMTM (Opia Technologies) Impression Cytology Device for conjunctival sampling~        3. Clinical ocular surface assessment with Oculus Keratograph 5M~        4. Collection of blood via venipuncture (optional)~        5. Retrieval of Clinical Information of participants~      The association of cytokines in the tears with various cellular and immune markers, as well~     as clinical signs of inflammation and tear stability will be investigated. This will be~     useful for further longitudinal studies of treatment in autoimmmune disease patients.~   "
103157|NCT02217124|"~     The primary objective of the proposed research is to determine the influence of 8 weeks of~     twice daily consumption of 120 kcal servings of dried apples or a commonly consumed low fat~     120kcal muffin on components of obesity (waist circumference [waist measurement], serum~     glucose [blood sugar], triglycerides [fats in the blood] and HDL-cholesterol, and blood~     pressure) as well as antioxidant status, inflammatory markers, nutrient intake in overweight~     and obese individuals. A total of 48 children aged 10-16 years will be randomly assigned to~     groups and provided with twice daily 120 kcal servings of either dried apples or muffins for~     8 weeks of feeding. Prior to initiating the feeding trial and again after 8 weeks, blood~     samples will be collected and analyzed. During each visit to the lab, subjects will be~     weighed in minimal clothing, tested for body composition using dual energy X-ray~     absorptiometry (DXA), bioelectrical impedance (BIA) and air displacement plethysmography (Bod~     Pod) and blood pressure, and measured for waist circumference. One 24-hour recall will be~     performed prior to initiation of the study; one recall will be performed throughout the~     feeding period, and one at the end of the 8 weeks. Dietary intake of energy, macronutrients,~     vitamins and minerals will be assessed to determine diet quality. All food records will be~     analyzed using the Nutritionist Pro (First DataBank) software. The potential benefits of the~     study include determining the effects of consistent snacking and particular snack foods on~     metabolism and weight management. There are no major risks to subjects in this study. There~     are minimal risks when performing venipuncture (blood draws) including bruising, perforation~     of the vein leading to hematoma under skin, light-headedness or dizziness due to fear of~     needles, and infection. This study will hopefully allow more understanding and insight into~     the diet of children and the effect of it on body makeup and blood sugar. It is hypothesized~     that the twice a day apple snack group will have decreased waist circumference, body~     adiposity, triglycerides and total cholesterol as well as, increased blood glucose uptake at~     the end of 8 weeks.~   "
103158|NCT02217111|"~     The purpose of this prospective study is to obtain preliminary data on changes in pre-post~     voice therapy outcomes in children diagnosed with vocal fold nodules, as a function of a~     series of cognitive operations. The primary outcome is voice-related quality of life~     (questionnaire). Secondary outcomes are standard acoustic and aerodynamic measures derived~     from sustained vowel and running speech samples.~   "
103159|NCT02217098|"~     The null hypothesis of this study is that GCC, GIC and compomer have the same survival rate~     when used for the treatment of occlusal and proximal caries in primary molars with ART under~     field conditions.~      This research will be done under field conditions in Barueri, a city in the state of São~     Paulo, Brazil. A total of 600 patients will be selected. After 1, 6, 12, 18 and 24 months the~     restorations and teeth will be evaluated by two independent evaluators. Only children whose~     parent or representative who have signed an informed consent are included in this~     research.The ART treatments will be done by two dental students. The operators will receive~     the same ART-training. The children will be randomly assigned to one of the operators. The~     restorative material to be used in each child will be assigned by another random list. It~     will be performed descriptive analyses to describe the sample. Bivariate analyses will be~     performed to test the hypothesis. The data will be analyzed with a chi-square test to compare~     the survival rates of GIC and GCC. Some co-variables will be evaluated, such as: operator~     effect, the influence of the cavity size on the survival rate, the position of the tooth, the~     dentists preferred side, the child's dmft/DMFT, contamination and finally the preoperative~     conditions. The effect of these variables on the survival rate will be evaluated using a~     regression analysis.~   "
104839|NCT02195102|"~     The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve~     Replacement (TAVR) in the Asian Pacific population~   "
103160|NCT02217085|"~     The purpose of this study is to determine the best way to ensure that polyps are completely~     removed by evaluating the borders of the removed polyp. If a polyp is found that meets the~     size requirements for the study, the investigators will take extra biopsies of the margin to~     determine if there is any abnormal tissue or cancer at these borders.~   "
103161|NCT02217072|"~     A Randomized controlled study of two different educational support interventions developed~     for children in foster care (age 6-13).~   "
103162|NCT02217059|"~     The purpose of this study is to evaluate the Congruence of Emergency Department (ED)~     Attendings' Predictions of Hypertension with Results of Home Blood Pressure Monitoring.~   "
103163|NCT02217046|"~     Cardiovascular implantable electronic device (CIED) infections have been increasing out of~     proportion to the number of devices implanted the investigators investigated recent trends~     and possible causes of the increasing numbers of Cardiovascular implantable electronic device~     infections.~   "
103164|NCT02217033|"~     The purpose of this study is to evaluate the effects of consuming R on quality of life in~     the areas of insomnia, fatigue, and depression in female breast cancer patients receiving~     multi-cycle adjuvant chemotherapy.~   "
103165|NCT02217020|"~     The standard treatment for stage 2/3 rectal cancer is neoadjuvant 5-Fu based chemoradiation.~     However, preoperative radiation cause kinds of adverse events, some were irreversible. And~     the survival benefit was not obvious. Whether chemotherapy alone is effective enough in~     treating rectal cancer is not yet known. Here, the investigators chose all the three active~     cytotoxic agents (5-FU, Oxaliplatin, Irinotecan) as the neoadjuvant treatment regimen~     (FOLFOXIRI). The purpose of the study is to evaluate the efficacy of FOLFOXIRI as neoadjuvant~     regimen in treating patients with locally advanced rectal cancer.~   "
103166|NCT02217007|"~     This is an open-label study of SNC-102 (acamprosate calcium sustained release tablet) in~     adult subjects with Tourette Syndrome. Subjects will be treated with oral doses of SNC-102~     800 mg on a BID basis - before breakfast and at bedtime - for 4 weeks and the same subjects~     will be treated with SNC-102 1600mg in the morning and 800mg in the evening for an additional~     4 weeks. Subjects will be assessed for changes in tic severity, safety, and pharmacokinetics.~     The study hypothesis is that treatment with SNC-102 will improve the tic severity in adult~     subjects with Tourette Syndrome.~   "
103167|NCT02216994|"~     1. The investigators previously reported a simple diagnostic scoring system to~          differentiate Hirschsprung disease (HD) from Hirschsprung disease allied disorders (HAD)~          in the patients with suspected intestinal dysganglionosis. In the retrospective study,~          the investigators concluded that the patients with a predicting score of more than 5 are~          more likely to be diagnosed with HD, whereas a score less than 5 is mostly indicative of~          HAD.~        2. Since it is essential to confirm the accuracy and efficacy of the scoring system in a~          prospective manner before it is used as a standard procedure, this prospective study is~          designed and performed.~   "
103168|NCT02216981|"~     The purpose of this study is to examine how feasible and acceptable it is to deliver a~     talking treatment called Cognitive Behavioural Therapy (CBT) in two different formats for~     people who have had treatment for OCD in the past but it didn't work out for them.~      The two different treatment formats are CBT delivered on a weekly basis (which is~     approximately 12-18 hours of therapy delivered weekly for 60-90 minutes each session,~     followed by 1-3 monthly follow up sessions as needed) and CBT offered in an intensive format~     (which is having approximately 12-18 hours of therapy all in a 3-week period, followed by 1-3~     monthly follow up sessions as needed).~   "
103169|NCT02216968|"~     The purpose of this study is to test the feasibility of an innovative approach to increase~     the amount of vegetable's (V) intake consumed by preschool children who are predominately~     African-American (AA) and Hispanic-American (HA).~   "
103170|NCT02216955|"~     China has the largest gastric cancer patients population all over the world. Recent reports~     concluded nutrition status and lifestyle factors were associated with gastric cancer risk,~     however, the influence of nutrition and lifestyle factors on cancer outcome in gastric cancer~     survivors is largely unknown.The investigators will explore the impact of nutrition status,~     life style, dietary pattern, obesity, physical activity, depression, diabetes, aspirin use~     and vitamin supplement on gastric cancer outcome. The investigators will recruit~     approximately 50,000 patients as a prospective study cohort. During follow up, the~     investigators will explore the association of these factors with disease-specific survival,~     disease-free survival and overall survival of patients. The investigators believe that this~     project will facilitate the establishment of domestic nutrition and lifestyle data of gastric~     cancer of China, and the improvement of the quality of clinical management of patients with~     gastric cancer.~   "
103171|NCT02216942|"~     The maintenance of primary teeth until their exfoliation has been one of the main purposes of~     Pediatric Dentistry, are they representing the fundamental basis for proper occlusion of the~     permanent dentition. Often, injuries or extensive dental caries reach the pulp of deciduous~     teeth making maintenance on these dependent endodontic treatment arc. Thus, this study was to~     conduct a randomized clinical trial with longitudinal follow-up of two years, double blind,~     to compare the degree of success of endodontic treatment in primary among the most used~     folder, Guedes Pinto paste, and one Calcium hydroxide and iodoform paste to control, Vitapex.~   "
103172|NCT02216929|"~     The demographic data, mortality rates and clinical diagnoses of the patients who were~     evaluated, intubated and interned to ICU by the anesthesiology department due to an urgent~     consultation call from the emergency department in 2010-2011.~      Primary outcome: an examination of demographic data, predicted mortality rates and the~     clinical diagnosis of the patients Secondary outcome: to determine the terminal cancer ratio~     Inclusion criteria: patients throughout the hole hospital whom was intubated by the~     anaesthesiology team due to an emergency consultation call Exclusion criteria: patients who~     refused treatment~   "
103191|NCT02216682|"~     To compare oral (PO) to intravenous (IV) acetaminophen with postoperative pain scores, and~     consumptions of opiates, among orthopedic surgery patients undergoing total knee replacement~     with spinal anesthesia.~      Our hypothesis is that IV acetaminophen patients will have improved analgesia, less opioid~     consumption, a lower percentage of patients rescuing, or a longer time to first rescue with~     IV acetaminophen. The investigators will compare the efficacies of oral and intravenous~     acetaminophen for postoperative pain control, and utilization of opiates as rescue agents.~   "
103173|NCT02216916|"~     Head and neck cancer is the sixth most common cancer and more than 650,000 new cases are~     diagnosed each year worldwide. About 60% of the HNSCC patients present with unresectable~     locally advanced disease at diagnosis and treated with multimodality approach. Despite such~     approach, majority (70%) of patients develop local or/and regional recurrences. Additional~     10% of patients present with distant metastasis at diagnosis. Most patients with recurrent or~     metastatic disease are treated with single agent chemotherapy, combination chemotherapy or~     targeted therapies.~      Despite its public health magnitude, HNSCC in Asian countries has received a limited~     attention for the drug development and cancer-related research. In fact, HNSCC ranked 7th~     among men and 10th among women by incidence in China, the largest producer and consumer of~     tobacco and alcohol. Recently, Chen et al. documented a 1:1:2 subset distribution for cancers~     of oral cavity, pharynx, and larynx in China, similar to the distribution reported in Korea~     but quite different from the general distribution of 5:2:3 in whites. Ethnic disparities in~     HNSCC also include its prognosis and this is partly explained by HPV-active disease ratio and~     genetic factors. Therefore, there is a strong need for an additional research in patients~     with HNSCC in Asia.~      Epidermal growth factor receptor (EGFR) is often over-expressed, and have been related to~     poor prognosis in patients with HNSCC. The association between EGFR-activated signaling~     pathways and tumor cell survival are well documented in many studies. EGFR targeting~     strategies showed clinical anti-tumor efficacy in patients with HNSCC, especially with~     monoclonal antibody, cetuximab. In the Extreme study, it was shown that the addition of~     cetuximab to platinum-5-FU significantly prolonged the median overall survival from 7.4~     months to 10.1 months compared to platinum-5FU alone in the first-line setting.~      HM781-36B is a irreversible pan-HER inhibitor. In preclinical studies, HM781-36B has much~     lower IC50 values than gefitinib in cell lines engineered to express EGFRvIII mutations and~     produces tumor growth inhibition in gefitinib-resistant xenografts. A phase I trial of~     HM781-36B in patients with advanced solid tumors showed clinically significant anti-tumor~     activity and a phase II trials of HM781-36B in patients with non-small cell lung cancer and~     advanced gastric cancer are currently ongoing.~      We suggest a phase II trial of HM781-36B in patients with recurrent or metastatic HNSCC who~     are resistant or ineligible/intolerant to platinum-based chemotherapy. The aim of current~     trial is to evaluate the antitumor efficacy and safety profile of HM781-36B and to identify~     biomarker to predict the tumor response to HM781-36B.~   "
103174|NCT02216903|"~     This is the evaluation which is associated with apnea symptom, one of the recurrence factors,~     after AF ablation to patients who diagnosed AF.~      This is the evaluation which is associated with excessive respiration exercise during AF~     ablation to patients who diagnosed AF.~      This is the evaluation which is associated with excessive respiration exercise to make a gap~     during AF ablation to patients who diagnosed AF.~   "
103175|NCT02216890|"~     This study will examine the safety profile of SGN-CD70A. The study will test increasing doses~     of SGN-CD70A given every 3 weeks (or an alternate dosing schedule up to every 6 weeks) to~     small groups of patients. The goal is to find the highest dose of SGN-CD70A that can be given~     to patients without causing unacceptable side effects. The pharmacokinetics and antitumor~     activity of SGN-CD70A will also be evaluated.~   "
103176|NCT02216877|"~     Randomized placebo-controlled interventional trial to investigate the effect of oral~     magnesium supplementation on intracellular magnesium in subjects with chronic kidney disease.~     We hypothesize that oral magnesium supplementation will increase intracellular magnesium in~     subjects with chronic kidney disease as well as increase serum magnesium.~   "
103177|NCT02216864|"~     The purpose of this study is to find out whether the use of multiple subcisions over several~     visits will improve the appearance of rolling acne scars compared to no treatment.~      This study was a pilot study designed to determine feasibility of this procedure.~   "
103178|NCT02216851|"~     The purpose of this study is to determine the safety and efficacy of using Restylane Perlane~     to shape the nasal dorsum and/or nasal root in comparison with a no-treatment control group~   "
103179|NCT02216838|"~     The purpose of this study is to find out if botulinum toxin A (botox®) can be used to treat~     facial flushing.~      This study is a pilot study designed to determine feasibility of these procedures.~   "
103180|NCT02216825|"~     Background: In recent years, probiotics have shown promise in treating a variety of diseases.~     Previously, the investigators have reported on the clinical efficacy of bile salt hydrolase~     active Lactobacillus reuteri NCIMB 30242 in improving the lipid profile in~     hypercholesterolemic adults.~      Objective: The purpose of the study is to investigate the effect of a delayed release or~     standard vegetarian capsule containing L. reuteri NCIMB 30242, taken in escalated dose over a~     4 week period, on the plasma bile acid profile.~      Design: The study design is a pilot, randomized, double-blind, dose-escalation study. The~     study will last a total of 6 weeks, including a 4-week intervention period and a 2-week~     washout period.~   "
103181|NCT02216812|"~     The reported prevalence of disproportionate pain and disability among patients recovering~     from a fracture of the distal radius varies widely. Literature reports numbers between 1% and~     37%, perhaps in part because it is poorly defined, known by so many different names,~     subjective, and unverifiable.~      The investigators are interested in the effect of vitamin C after distal radius fractures on~     objective measurement of finger motion, patient reported outcome measures, and pain~     intensity, instead of the previously used, subjective and imprecise criteria for complex~     regional pain syndrome.~      Patients presenting to the Hand and Orthopaedic Trauma Services of MGH with a distal radius~     fracture will be asked to participate in this clinical trial. Patient will be randomly~     assigned to take either placebo or vitamin C 500 mg until full finger motion is attained as~     regarded by the treating physician at follow-up or for 6 weeks.~      The investigators hypothesize no difference in finger stiffness at 6 weeks measured by~     distance to palmar crease of the index through little finger between patients taking vitamin~     C or placebo after a distal radius fracture. Additionally, the investigators assess finger~     stiffness by range of motion and stiffness of the thumb, and difference in PROMIS upper~     extremity function and pain score both measured at six months.~   "
103182|NCT02216799|"~     Hyperglycemia increases the risk of complications in surgical patients. Focus on poor~     glycemic control as a contributor to adverse outcomes in settings outside the intensive care~     unit (ICU) is often dismissed. Total parenteral Nutrition (TPN) has been used in providing~     surgical patients with nutrition to prevent deterioration of nutritional status. However,~     many diabetic patients receiving TPN develop exaggerated hyperglycemia that requires frequent~     insulin administration via sliding scale. Providing diabetic patient's receiving TPN basal~     insulin is a known strategy to aid in blood sugar control and prevention of high blood sugar~     spikes. Many strategies for basal insulin provision have been utilized clinically during the~     administration of TPN; this includes the incorporation of insulin with TPN solution or~     administration of long acting insulin such as glargine. However, no study has compared any of~     these strategies aiming for selecting the optimum modality for controlling blood glucose in~     diabetic surgical patient's receiving TPN. We will conduct a study to compare the efficacy of~     once daily insulin glargine versus continuous regular insulin incorporated TPN in controlling~     blood glucose in non-critically ill diabetic surgical patients receiving TPN.~   "
103212|NCT02216409|"~     The purpose of this study is to assess the safety and tolerability of Hu5F9-G4 in~     participants with solid tumors.~   "
103183|NCT02216786|"~     This is an open-label, multicentre, 4-arm randomised phase II trial of fulvestrant + AZD2014~     versus fulvestrant + everolimus versus fulvestrant alone in patients with ER-positive,~     HER2-negative advanced or metastatic breast cancer, whose disease relapsed during treatment~     with (or within 12 months after discontinuation of) an AI in the adjuvant setting or~     progressed during treatment with an AI in the metastatic setting. Patients will be randomised~     (2:3:3:2) to one of the four treatment arms:~        -  Fulvestrant~        -  Fulvestrant + AZD2014 (continuous daily schedule)~        -  Fulvestrant + AZD2014 (intermittent schedule - 2 days on, 5 days off)~        -  Fulvestrant + everolimus~      Randomization will be stratified by the following criteria:~        -  Measurable disease (vs. non-measurable).~        -  Sensitivity to prior endocrine therapy (sensitive versus resistant)~   "
103184|NCT02216773|"~     The aim of this study is to compare two different techniques (portal vein embolization and~     radiofrequency assisted liver partition with portal vein ligation) for increasing liver~     volume prior to major liver resection.~   "
103185|NCT02216760|"~     The heart beat is controlled by electrical signals. Following a heart attack, part of the~     heart muscle dies and is later replaced by scar tissue. Within this area of scar, there often~     remain channels of surviving tissue still able to transmit electrical signals. However, it~     is well established that these conduction channels (CC) can form a short circuit around the~     scar, leading to electrical disturbances (arrhythmias) that are potentially life threatening.~     The commonest of these is ventricular tachycardia (VT), and is estimated to cause 300,000~     deaths per year.~      One recognised treatment option of VT involves burning (ablation) these conduction channels~     (CC) within the scar. However, at present, the procedure is long and is far off 100%~     effective. Consequently, current best practice does not rely on treating the VT, but rather~     preventing it from causing sudden death - this is achieved with an Implantable Cardioverter~     Defibrillator (ICD), a device which can recognise when a patient is in VT and deliver an~     internal shock to restore the normal electrical conduction. Patients with defibrillators~     subsequently are subject to recurrent painful and debilitating shocks which, although~     lifesaving, significantly reduce their quality of life. The limitation with ablation at~     present is due to the difficulty in visualising these CC's.~      Investigators at Imperial College have created a novel electrogram visualisation program,~     Ripple Mapping (RM), which they have already found to be superior to currently used~     programmes in cases of arrhythmias in the upper chambers of the heart (the atria). During a~     retrospective study in patients with scar related VT following a heart attack, when ablation~     was delivered in areas associated with identified Ripple Mapping Conduction Channels, these~     patients remained free of VT recurrence for >2 year follow up interval.~      The study hypothesis is that Ripple Mapping can identify all conduction channels within scar~     tissue critical to the VT circuit, ablation of which will lead to long-term freedom from VT~     and ICD therapies. The investigators now aim to perform a prospective randomised study~     comparing Ripple Mapping guided VT ablation against conventional VT ablation.~   "
103186|NCT02216747|"~     Background- Idiopathic Nephrotic syndrome is the common glomerular disease in childhood.~     conventional treatment is steroid treatment and nearly 90% response to this treatment well.~      Response to this treatment is the most important prognostic factor and this patients has a~     benign disease course.~      60-70% among patients that response to steroid treatment,will suffer a relapse of NS.repeated~     steroids courses can lead to serious adverse events in children such as low bone~     density,weight gain ,growth slow down ,elevated blood pressure and eye pressure.there is side~     effect corelation between steroid dose and treatment duration.~      guidelines for steroid dose for NS relapse are not based on retrospective clinical research~     but only on Nephrologists and experts opinion.~      Rational- What would be the optimal low dose steroids and the shortest time of treatment in~     Nephrotic syndrome relapse?~   "
103187|NCT02216734|"~     The investigators hypothesize that a strategy of establishing facility-based mother support~     groups (MSGs) for HIV-positive mothers will result in increased retention rates of~     HIV-exposed infants in clinic-based PMTCT follow-up systems twelve months post-delivery~     compared to clinics that lack MSGs. The study will be conducted in health facilities in rural~     Mutare and Makoni health districts in Manicaland province, Zimbabwe. A two-arm cluster~     controlled study design will be used in 30 rural clinics randomly assigned to either arm to~     compare the effectiveness of MSGs. Arm 1 of the study consists of standard of care whilst arm~     2 consists of standard of care together with facility-based MSGs.~   "
103188|NCT02216721|"~     Primary aldosteronism (PA) is a disorder of the adrenal gland causing an autonomous~     overproduction of mineralocorticoids, leading to arterial hypertension. Although rare, it is~     the most frequent cause of secondary hypertension. Early detection is important to avoid end~     organ damage, specifically cardiovascular and metabolic morbidity. Recent studies showed a~     positive correlation between patients with PA with lower bone density especially at the~     spine, with significant improvement post treatment, either medically or surgically. There was~     also a positive correlation between high aldosterone renin ratio with higher levels of intact~     parathyroid hormone (iPTH) which is responsible for cortical bone loss especially at the~     distal forearm.~      We hypothesize that our patients with PA have a higher level of iPTH, with lower bone density~     especially at the distal forearm, with improvement post treatment.~   "
103189|NCT02216708|"~     The recommendation for correction of dehydration of severely malnourished children with~     diarrhoea includes oral rehydration and if parenteral rehydration is necessary (for example,~     in severe dehydration) to infuse intravenous fluids very slowly due to the concern of heart~     failure. There is not enough evidence to convince some of the physicians dealing with~     severely malnourished children with dehydrating diarrhoea (for example, cholera) that rapid~     rehydration per se is associated with increased incidence of over hydration and heart~     failure. And whether this approach is applicable in the management of severely malnourished~     children with severe cholera, which usually require rapid correction of water and electrolyte~     deficits for prevention of deaths due to hypovolaemic shock and other complications, has not~     been studied carefully. Recently, we have demonstrated that rapid intravenous rehydration~     (within 4 to 6 hours) of severely malnourished children with dehydrating cholera replacing~     appropriate amount of fluid was found to be safe. We feel that rapid rehydration would help~     in improving the renal function, acidosis and thus improve appetite and reduce ORS failure~     subsequently. Since our study was uncontrolled, so we have planned a randomised controlled~     study with adequate sample of 250 participants; 125 will be rehydrated slowly (over 10 to 12~     hours) following WHO guideline and 125 patients will be rehydrated with intravenous fluid~     over 6 hours. Children of either gender, age 6 to 60 months, severely malnourished (Wt for~     length <-3 Z score of WHO growth chart or with nutritional oedema) with a history of watery~     of <24 hours with signs severe dehydration attending the ICDDRB Dhaka hospital will be asked~     to participate in this study. After the parents'/Legal guardian's consent, the children will~     be transferred to the study ward and will be treated according to the protocol. All children~     will receive similar treatment except the mode of rehydration, different for the two groups.~     The children will be closely monitored throughout the study period. The primary outcomes~     incidence of over hydration and ORS failure and secondary outcomes improvement of renal~     function and improvement of appetite measured by the food intake will be compared between the~     groups.~   "
103190|NCT02216695|"~     The true population incidence of acute kidney injury (AKI), previously called acute renal~     failure, in England is not known. A better understanding of the epidemiology of AKI at a~     national level is essential to inform initiatives to prevent AKI as well as reduce the~     associated morbidity and mortality. The purpose of this study is to combine the national~     database of all hospital discharges with national census data to investigate trends in the~     incidence of both, AKI not requiring dialysis and AKI requiring dialysis, as well as its~     associated mortality and its determinants in England between 1998 and 2013~   "
103192|NCT02216669|"~     This is a Phase I multicenter, open-label, dose-escalation study of DTP348. DTP 348 is an~     oral dual drug with two mechanisms of action:~        1. carbonic anhydrase IX inhibitor which acidifies the intracellular pH through the~          sulfamide components~        2. radio sensitizer of hypoxic cells through its 5-nitroimidazole moiety~      The study will be conducted in 2 parts. The phase I trials will be on the standard 3+3 design~     first as single agent then combined with radiotherapy:~        1. A single agent dose-escalation phase in patients with solid tumours.~        2. A dose-escalation phase in patients with HNSCC in combination with radiotherapy~      The main objective is to determine the recommended phase II dose of DTP348 in combination~     with radiotherapy~   "
103193|NCT02216656|"~     This randomized, placebo-controlled, double-blind (included open arm of KRN1493~     (cinacalcet)), parallel-group, multi-center study is designed to evaluate efficacy and safety~     in cohorts comprising KHK7580, its placebo and KRN1493 (cinacalcet) orally administered for~     three weeks for secondary hyperparathyroidism patients receiving hemodialysis.~   "
103194|NCT02216643|"~     Prospective, multi-center, randomized, controlled, open, blinded-endpoint trial with a~     sequential design. The randomization employs a 1:1 ratio of mechanical thrombectomy with~     stentriever and/or Thromboaspiration versus medical management alone. Randomization will be~     done under a minimization process using age, baseline NIHSS, use of IV tpa, vessel occlusion~     site and hospital. To evaluate the hypothesis that mechanical thrombectomy is superior to~     medical management alone in achieving more favorable outcomes in the distribution of the~     modified Rankin Scale scores at 90 days in subjects presenting with acute large vessel~     ischemic stroke <8 hours from symptom onset. Subjects are either ineligible for IV alteplase~     or have received IV alteplase therapy without recanalization. Sample size is projected to be~     690 patients for a difference in treatment effect of 10%.~   "
103195|NCT02216630|"~     This will be an open-label, non-randomized multi-center study designed to assess the safety~     and efficacy of Adipose-derived Stem Cell (ASC) IV implantation. The therapy is composed of~     cells isolated from a patient's own adipose tissue. Liposuction will be performed to collect~     the adipose tissue specimen for subsequent processing to isolate the stem cells.~   "
103196|NCT02216617|"~     The purpose of the study is to determine the maximum tolerated dose (MTD) of afatinib~     administrated in combination with docetaxel (Taxotere®) and cisplatin in induction~     chemotherapy of locally advanced head and neck carcinoma in order to move to a phase II,~     allowing the comparison with standard induction chemotherapy TPF.~      It is a multicentric, national, opened, not-randomized phase Ib. Three doses of afatinib (20,~     30 and 40 Mg per day) will be studied in combination with the fixed standard doses of~     docetaxel and cisplatin. For each dose level, beginning with smallest (20 Mg per day of~     afatinib), 3 to 6 patients will be treated at maximum, i.e. 3 cycles of three weeks treatment~     each one (9 weeks on the whole). The next dose level will be studied only if the previous~     dose is well tolerated for the period of the first 4 weeks observation of the treatment (1st~     cycle more first week of the 2nd cycle). Once the MTD is determined, four additional patients~     will be treated with this dose. A maximum of 22 patients should be included in this study.~     The total duration of the study is estimated at 18 months. In case of major safety problems,~     the study may be stopped earlier. In short, the preclinical data, pharmacological and~     clinical on afatinib indicate that the benefit-risk ratio can be regarded as positive and~     that the association of afatinib with cisplatin and docetaxel could be effective in patients~     with head and neck squamous cell carcinoma potentially resulting in an extension of time to~     progression.~   "
103197|NCT02216604|"~     Today about 80% childhood cancer patients become long-time survivors. In spite of the high~     cure rates the diagnosis cancer is associated with a variety of disease and treatment-related~     psychological and physical impairments mostly present into adulthood. So the attention has to~     focus on the improvement of these problems such as motor limitation, dysfunction of the~     cardiovascular system, reduced muscle strength, overweight, osteoporosis and diminished~     quality of life (Qol). Although exercisel intervention studies in this field are generally~     scarce, the results of these studies are promising. Up to now studies during the acute phase~     of treatment are missing almost completely. The aim of this feasibility study is to evaluate~     the potential benefits of a modular exercise intervention program for childhood cancer~     patients startunf in parallel with treatment and longlasting for one year. Across two years~     cancer patients of the Children's Hospital of the University Clinic of Heidelberg aged 5-21~     years, free of any contraindications for physical activity will be recruited. All~     participants are asked to complete a physical assessment battery (strength, endurance and~     balance capacity, posture control, functional mobility, range of motion) and additionally two~     questionnaires concerning Qol and motivation, at baseline and every three months following~     one year~   "
103198|NCT02216591|"~     The proposed study will test the efficacy of a cognitive training program to improve working~     memory in a sample of HIV-infected persons. Investigators will assign 40 HIV-infected adults~     with poor medication adherence to one of two conditions (20/group): the experimental~     cognitive training intervention or a control training condition. Participants will complete~     12 training sessions across 10 weeks and will complete assessments at baseline and~     post-training. The specific aims are to:~        1. Investigate the effects of the cognitive training intervention on working memory and~          delay discounting in HIV-infected persons.~           Hypothesis 1: Participants assigned to active cognitive training, compared to those in~          the attention-matched control group, will have greater improvements in working memory~          and reductions in delay discounting.~        2. Characterize adherence to antiretroviral medications in this population and examine~          medication adherence after cognitive training.~      Hypothesis 2: Participants assigned to active cognitive training, compared to those in the~     attention-matched control group, will have greater improvements in medication adherence.~   "
103199|NCT02216578|"~     The study is a multi-center, multi-national, open label, single arm Phase II study of~     single-agent cabozantinib. The objective of the study is to assess the safety and activity of~     cabozantinib in patients with metastatic GIST who have previously progressed on imatinib and~     sunitinib and have not been exposed yet to other KIT- or PDGFR-directed tyrosine kinase~     inhibitors.~      Patient will receive cabozantinib until they experience no further benefit from the~     treatment, becoming intolerant to the drug or wishing to discontinue the treatment. Treatment~     beyond RECIST 1.1 progression is allowed in patients deriving clinical benefit upon~     investigator's discretion, provided no other criteria for treatment withdrawal are met.~   "
103200|NCT02216565|"~     This trial aims at comparing two strategies currently used to address acute ischemic stroke~     of the middle cerebral artery : medical treatment without endovascular treatment on the one~     hand, and medical treatment plus endovascular treatment on the other hand. The efficiency of~     the strategies will be assessed in terms of early neurological clinical recovery.~      The study will focus on three particular situations : (1) tandem internal carotid and middle~     cerebral artery occlusion, (2) situations where patient cannot benefit from fibrinolysis~     because of high risk of haemorrhage, (3) situations where fibrinolysis is not recommended~     because of a delay superior to 4.5 hours.~      The hypothesis to be tested is that medical approach plus endovascular treatment is superior~     to medical treatment alone~   "
103201|NCT02216552|"~     The current project is designed as a 30-day pilot trial to demonstrate the safety and~     tolerability of resveratrol therapy in overweight adolescents to decrease liver fat, and~     improve insulin sensitivity to prevent type 2 diabetes.~   "
103202|NCT02216539|"~     Patients benefitting from a lung transplantation are subject to long-lasting and often severe~     post-operative pain. Self-hypnosis has been proven effective in the management of acute pain.~      The study hypothesis is that pre-operative training in self-hypnosis given to patients~     awaiting lung transplantation, will result in a reduction of post-operative pain one month~     after surgery.~   "
103203|NCT02216526|"~     Residents of institutional long-term care facilities are at high risk for developing skin and~     tissue diseases, e.g. xerosis cutis (including pruritus), infections (e.g., tinea pedis,~     candidiasis), chronic wounds or neoplastic changes (e.g. actinic keratosis, malignant~     melanoma) but there are few epidemiological figures about the actual frequencies of these~     conditions in nursing homes. Therefore, in the first part of this study we aim at measuring~     key dermatological conditions and associated health and functional status, and the skin care~     practice of aged nursing home residents (prevalence study).~      Basic skin care interventions are believed to reduce skin dryness and to enhance skin health.~     Thus, the second aim of this study is to investigate the effectiveness of two structured skin~     care regimens compared to the routine standard skin care on skin health in nursing home~     residents (intervention study).~      The study will be conducted in a random sample of seven out of approximately 300~     institutional long term care facilities of the federal state of Berlin.~   "
103204|NCT02216513|"~     The investigators will test the central hypothesis that DFO treatment after SAH may improve~     cerebrovascular regulation, mitigate ischemic neural injury, and serve as an effective~     neuroprotectant against delayed ischemic injury after SAH.~   "
103205|NCT02216500|"~     Approximately a fourth of children with seizures do not respond adequately to available~     therapy. Ketogenic therapy has a long history as treatment for intractable epilepsy, but~     there is no agreement concerning how it works and what is the best way to administer it. This~     natural history study will collect data pertaining to both questions.~   "
103206|NCT02216487|"~     As an approach to improve efficacy and provide clinical benefit to cancer patients undergoing~     chemotherapeutic treatment regimens, Alchemia Oncology has developed a novel means for~     delivering anti-cancer agents to tumours. The drug delivery platform is based on the use of~     hyaluronic acid (HA), a novel excipient, in which, formulation with HA results in~     optimisation of cytotoxic drug uptake and retention within solid tumours. In the specific~     example of HA-Irinotecan, this new formulation of irinotecan has demonstrated enhanced~     efficacy in both nonclinical and early clinical studies.~      The current study is an investigation into the use of HA-Irinotecan in a Phase II single arm~     trial of FOLF(HA)iri plus cetuximab in irinotecan-naïve second line patients with KRAS wild~     type metastatic colorectal cancer. The study objectives are to confirm the safety and~     efficacy of FOLF(HA)iri plus cetuximab as second-line therapy in irinotecan-naïve metastatic~     colorectal cancer patients.~      It is expected that the study recruit approximately 40-50 patients in 1 year with subsequent~     treatment and follow up; thus the trial will run for approximately 2-3 years.~   "
103207|NCT02216474|"~     Brain stimulation in movement disorders~      This trial will explore the effects of very gentle electrical stimulation of the brain in~     patients with movement disorders. Other studies have already been carried out and have shown~     that brain stimulation may help to improve mental abilities and the symptoms of conditions~     such as depression and stroke. The investigators will show whether this method can help with~     symptoms such as memory and concentration problems in patients with movement disorder who~     have mild to moderate problems with these mental abilities. The investigators will also look~     at the effects of brain stimulation on movement symptoms and mood. These people will be~     compared to healthy people to help us understand whether brain stimulation works differently~     in healthy people and people with brain disorders.~      This trial is being carried out at one centre in Birmingham. It is scheduled to begin in~     September 2014 and will last for up to five years. As the study commences it is being funded~     by Birmingham and Solihull Mental Health Foundation Trust and University of Birmingham. The~     investigators plan to recruit up to a maximum of 200 individuals in this study.~   "
103208|NCT02216461|"~     To investigate safety, tolerability, and pharmacokinetics of BIBW 2948 BS after repeated~     dosing~   "
103209|NCT02216448|"~     The purpose of this study is to compare between two groups of residents with basic~     arthroscopic skills in diagnostic knee arthroscopy. The first group will train on a knee~     arthroscopic simulator in a lab, and the second group will perform diagnostic knee~     arthroscopy in the operating room. Both groups will be assessed by senior arthroscopy surgeon~     in the operating room based on selected competencies following the Global Rating System.~   "
103210|NCT02216435|"~     Parkinson's Disease (PD) is a movement disorder causing either uncontrolled movement,~     slowness of movement, slowness of initiation of movement or rigidity of muscles. Deep Brain~     Stimulation (DBS) is the FDA-approved method for patients who no longer get effective~     treatment from the best available medication. The location in the brain where the electrode~     is placed during DBS surgery for PD is called the Subthalamic Nucleus or STN. This study aims~     to investigate another location in the brain, the Substantia nigra pars reticulata or SNr.~     The SNr is also known to be involved in motor control of muscles and may be involved in the~     process by which the initiation of movement occurs.~   "
103211|NCT02216422|"~     This was a multicenter study evaluating the efficacy and safety of~     ombitasvir/paritaprevir/ritonavir and dasabuvir co-administered with ribavirin (RBV) for 12~     weeks in treatment naïve and pegylated-interferon alfa-2a or alfa-2b (pegIFN)/RBV~     treatment-experienced, cirrhotic HCV genotype 1b-infected adults.~   "
103213|NCT02216396|"~     One third of the population, aged over 65, live and will die with dementia. Half of people~     with dementia experience symptoms of agitation every month. Symptoms of agitation include~     restlessness, pacing, shouting and verbal or physical aggression. Many people with agitation~     are admitted to care homes as families find they cannot care for them at home. Within the~     care home, staff also often find managing people with agitation difficult and they react in a~     wide range of ways. Agitated behaviour takes up staff time and emotional and physical energy~     but they do not always know how to respond. This study is one of the streams in an integrated~     programme to help tackle agitation in a variety of settings from domestic environments to end~     of life.~      Our primary hypothesis is that for people with dementia living in care homes, paid carer use~     of dysfunctional coping strategies predicts lower quality of life in residents with dementia~     and that this is more so at higher levels of agitation.~      We will recruit 60-80 care homes (residential or nursing homes). We will identify all~     residents with dementia, and the care home manager will approach them and their family~     carers. After obtaining informed consent, or advice from personal or nominated consultees for~     those lacking capacity, we will ask people with dementia who can answer questions about their~     quality of life using the DEMQOL. We will also ask staff and their family carers for those~     who have them, to rate the quality of life of the person with dementia using the DEMQOLproxy.~     We will ask care home staff other questions about residents with dementia, including about~     agitation, using the Cohen-Mansfield Agitation Inventory (CMAI), and the care they receive.~     Staff will also answer questions about the ways they cope with caring stresses, using the~     COPE. We will measure quality of life and agitation 5 times over 16 months. We will use our~     results to test our theory that agitation is an important factor determining residents~     quality of life, and that the ways staff cope with stress affect the impact agitation has on~     quality of life.~   "
103214|NCT02216383|"~     BACKGROUND Around a quarter of all global pregnancy and child-birth related deaths are due to~     excessive bleeding after the birth of the baby and placenta, or post-partum haemorrhage~     (PPH). In the UK, PPH affects approximately 10% of new mothers. PPH can be extremely~     frightening for women and can cause them to need additional treatments including blood~     transfusion and removal of the womb as well as prolonging their hospital stay.~      The most common cause of PPH is an inadequately contracted womb after childbirth. Giving the~     mother an injection of uterotonic medicine following the birth of their baby can prevent~     this. It reduces the risk of PPH by 66% and this should routinely be offered to all labouring~     women.~      In the UK, the two medicines most commonly used for this purpose are Syntocinon and~     Syntometrine. Both mimic natural hormones. Syntometrine is longer acting, but a published~     review of trials comparing these two medicines concluded that Syntometrine is no better at~     preventing severe blood loss. Syntometrine is associated with more side effects including~     nausea, vomiting, and high blood pressure, and has been linked with rare, but fatal, cases of~     stroke. All guidelines therefore recommend Syntocinon for preventing PPH.~      Our group conducted a telephone survey of all maternity units in the UK, and found that 71.4%~     of units still routinely use Syntometrine. Investigators estimate that 40,000-70,000 women~     per year are experiencing distressing nausea and vomiting in the emotionally important first~     few hours following childbirth. These women are also receiving a medicine with the potential~     to cause dangerous high blood pressure.~      Carbetocin is a newer medicine, already widely used after caesarean section, but not yet~     after vaginal birth. Other studies have shown that Carbetocin is slightly better at~     preventing bleeding after birth when compared to Syntometrine, that it has fewer side effects~     than Syntometrine, and that it may be just as good as Syntocinon at preventing PPH. No~     studies have directly compared all three medicines or compared their overall cost;~     information vital to the NHS.~      METHOD Investigators propose a trial of 6285 women over 13 months, in four maternity units in~     the South-West to compare the effectiveness, side effects and cost of Syntocinon,~     Syntometrine and Carbetocin, for women having a vaginal birth.~      Women will be randomly allocated to receive one of these drugs. Women and staff will not know~     which drug they receive, so as not to influence the results collected. Staff will collect~     data such as the number of extra drugs and treatments needed and the volume of blood lost.~     Women will be asked to complete a side effects questionnaire. Investigators will perform an~     analysis of cost effectiveness once all results are available.~      AIMS Investigators aim to establish whether Carbetocin is an effective and affordable~     alternative to Syntocinon and Syntometrine, and whether it has fewer side effects for new~     mothers. Publication of our results, regardless of what they find, could potentially improve~     the birth experience of women across the UK, and support the health service in spending its~     money most effectively.~   "
103215|NCT02216370|"~     Atrial fibrillation (AF) is the significant risk factor of ischemic stroke with incidence~     about 20% of all ischemic strokes. The undiagnosed AF in cryptogenic stroke patients could be~     present but not revealed by rutinne ECG.~   "
103216|NCT02216357|"~     The primary objective of the study is to determine the safety of oral ifetroban compared to~     placebo as measured by a > 20% decrease in FEV1 compared to baseline following a dose of~     Investigational Medicinal Product (IMP) (Study Day 1 or 2) prior to initiation of the aspirin~     challenge.~   "
103217|NCT02216344|"~     The primary objective of the study is to validate the proposed claims for the OxiCable~     device, for pulse rate and saturation accuracy in a diverse subject population over a~     specified saturation range.~   "
103218|NCT02216331|"~     This is a open-label study, 2-treatment, 2-period, single sequence design. Period 1 will~     examine the pharmacokinetics of TMC207 in the absence of rifapentine or rifampicin. Subjects~     will receive a single 400-mg dose of TMC207 administered alone on Study Day 1. Period 2 will~     examine the effects of repeated doses of either rifapentine or rifampicin on TMC207~     pharmacokinetics and will begin on Study Day 20. During Period 2, subjects will receive 22~     daily doses of either 600 mg rifapentine or rifampicin from Study Day 20 through Study Day~     41. A single 400-mg dose of TMC207 will be administered on Study Day 29. Subjects will be~     confined to the clinic from Study Day-1 to Study Day 2 in the morning of Period 1, and Study~     Day 19 to Study Day 30 in the morning of Period 2. The study hypothesis is to determine~     whether Rifapentine affects the pharmacokinetics of TMC207 as measured by effects on Cmax and~     AUC(0-t) to a lesser degree than rifampicin.~   "
103219|NCT02216318|"~     to investigate the effect of two lightning conditions on sleep hypothesizing that sleep~     length is influenced by the color of light during daytime~   "
103220|NCT02216305|"~     HYPOTHESIS~        1. HAL- RAR causes a lower immediate postoperative pain compared with erxcision~          hemorrhoidectomy.~        2. HAL - RAR achieves similar immediate and long term results compared to the excision~          hemorrhoidectomy in the control of hemorrhoidal symptoms.~        3. The complication rate of HAL- RAR is low and similar to excision hemorrhoidectomy.~      OBJECTIVES~        1. Compare postoperative pain of both techniques.~        2. Assess the short and long-term control of hemorrhoidal symptoms by HAL- RAR technique,~          and compare the results with those of the excision hemorrhoidectomy.~        3. Evaluate and compare the rate of complications of both techniques.~        4. Assess the quality of life of patients before and after treatment.~      MATERIAL AND METHODS~      The trial was subjected to evaluation and accepted by the Ethics Committee of the Fundació~     Unió Catalana d'Hospitals (Catalonian Union of Hospitals Foundation).~      All patients with grade III and IV hemorrhoids that are eligible for surgical treatment with~     both methods who agree to participate in the study, will be included in the prospective~     randomized trial. All patients will be required to sign the specific informed consent.~      Patients who are suitable for treatment with both techniques will be randomly assigned to the~     surgical technique.~      Inclusion criteria:~      1. Patients with symptomatic grade III or IV hemorrhoids (bleeding, pain, itching, soiling or~     prolapse) that are eligible for surgical treatment with both methods.~      Exclusion criteria:~        1. Associated recto-anal pathology such as acute thrombosed hemorrhoid, anal fissure,~          perianal fistula, perianal abscess, rectal prolapse, fecal incontinence or anal~          stenosis.~        2. Prior anorectal surgery .~        3. Systemic pathology that could alter the outcome of the surgery as coagulopathies,~          chronic pain with continued consumption of analgesics.~        4. Age younger than 18 or older than 80 years, socio-pathology or inability to understand~          the study objectives.~      All surgeries are performed on an outpatient basis under regional anesthesia and sedation for~     the same team of three surgeons. Preoperative preparation consists of a cleansing enema and~     no prophylactic antibiotics will be administered.~      Both techniques will be performed in Jack -Knife position. The open hemorrhoidectomy may~     include one to three anal cushions and made according to the Milligan-Morgan technique, with~     resection of the anal cushion and the external hemorrhoidal epidermal component using~     electrocautery and ligation of the hemorroidal base with absorbable suture. Once completed~     hemorrhoidectomy a perianal block is performed with bupivacaine/epinephrine.~      Hemorrhoidal artery ligation and rectoanal repair will be performed with the AMI minimally~     invasive surgery device HAL/RAR, and consist in the ligation of the terminal branches of the~     superior rectal artery with 2-0 absorbable polyglycolic acid suture after identifying the~     blood flow approximately 3 cm above the dentate line by using Doppler guidance. Subsequently,~     a running suture was added from the suture point to 5 mm above the dentate line to lift the~     prolapsing hemorroid. Other procedures will not be associated, if necessary, the patient will~     be excluded from the study .~      The patient will be discharged if adequate pain control, oral tolerance and spontaneous~     diuresis is achieved, and after examination by the surgeon in order to discard immediate~     complications. The ambulatory treatment consists of an osmotic laxative (magnesium hydroxide~     ), oral analgesia with paracetamol/tramadol ( 325mg/37.5mg ) every 6 hours and Dexketoprofen~     (25 mg) every 8 hours, metamizol (575 mg) may be associated every 8 hours if pain. In case of~     persistent pain, the patient will be examinated in emergency room.~      EVALUATION OF RESULTS A power analysis was performed to assess the study sample size.~     Choosing a power of 0.8 and a confidence interval of 95% α-error of 0.05, we calculated that~     26 patients were needed in each arm. We increased this number up to 30 to increase~     reliability of the study.~      All patients will be evaluated with a validated questionnaire of 36 questions on quality of~     life ( SF-36 ) and specific questions about specific symptoms of hemorrhoidal disease (pain,~     itching , bleeding, soiling and hemorrhoidal prolapse reduction ). The questionnaire will be~     answered before the intervention, after six and twelve months of follow up.~      All patients will complete a diary testing global postoperative pain every day, measured on a~     numerical scale from 0 to 10 during the first 15 days.~      The patients will be assessed on the day of discharge and at 7, 14, and 30 postoperative~     days. The patients will be evaluated at 6, 12 and 24 postoperative months in the outpatient~     clinic.~   "
103221|NCT02216292|"~     Human milk is the best source of enteral nutrition for the preterm infant. However during the~     infants first hours and days of life breastmilk from the own mother is usually not available.~     Until May 2012 the practice in the Neonatal Division of the Department of Pediatrics /Medical~     University Vienna was to start with formula feedings within the first 6 hours of life of a~     premature infant and switch over to breastmilk as soon it was available. In June 2012 the~     investigators changed this feeding regimen and started to use single donor milk of mothers of~     preterm infants for the first hours and days of the preterm infants life. In a prospective~     observational study the investigators evaluated the impact of single donor milk from preterm~     infants on time to full enteral feedings, gastrointestinal tolerance and NEC incidence in~     preterm infants with a birthweight below 1500 grams and a gestational below 32 weeks. Data~     will be compared with a historical control group starting with preterm formula as source of~     enteral nutrition. The investigators hypothesize that starting enteral nutrition with single~     donor milk of mothers from preterm infants with shorten time to full enteral feedings.~   "
103222|NCT02216279|"~     Pulmonary hypertension or elevation of the pressure in the pulmonary vessels, results from~     various clinical conditions. It may be idiopathic (of unknown cause) or associated with~     numerous diseases including cardiovascular and lung disorders. Affected individuals suffer~     from progressive shortness of breath and, in its most sever forms; pulmonary hypertension~     carries a worse prognosis than many types of cancer. There is no test currently that can~     easily and non-invasively detect abnormalities of the pulmonary circulation. Presently there~     is no cure for pulmonary hypertension and substantial research efforts are dedicated to the~     development of new drugs that will stop progression or better yet, reverse the disease~     process. The investigators do not know if any of the drugs currently commercialized for~     pulmonary hypertension directly improve the status of the pulmonary vessels since no test~     currently provides this information. Direct earlier detection of lung vessel abnormalities~     associated with pulmonary hypertension using a sensitive and non-invasive test would allow~     not only earlier testing of these and of new drugs, but would provide a much better surrogate~     of disease severity allowing more efficient pre-clinical drug testing. The aim of this phase~     II study is to evaluate the safety of PulmoBind in participants with pulmonary hypertension~     and its potential to detect abnormal pulmonary circulation associated within pulmonary~     hypertension.~   "
103223|NCT02216266|"~     Evaluation if physostigmine reduces symptoms in patients who has developed a delirium in~     Intensive care after a surgery~   "
103224|NCT02216253|"~     This study will include women who will undergo pelvic reconstructive surgery and/or~     anti-incontinence sling procedures. Patients will be randomized to the combination of~     L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract in tablet or placebo twice a day~     during the seven days before and after surgery (total of 14 days). In this randomized,~     double-blind study, the investigators will assess treatment of clinically suspected or~     culture-proven urinary tract infections within 3 weeks of surgery (primary outcome), and risk~     factors for treatment for postoperative urinary tract infections (secondary outcomes) between~     the two study groups.~   "
103257|NCT02215824|"~     The primary aim of this trial was to investigate the safety of a 6 hour intraarterial~     infusion of BIWH 3 (pyro-Glu-rhMCP-1) in patients with severe peripheral arterial occlusive~     disease (PAOD) and chronic Critical Limb Ischaemia (Fontaine class III or IV).~   "
103225|NCT02216240|"~     Supraventricular tachycardia (SVT) is a term describing any rhythm coming from the top half~     of the heart. Although atrial fibrillation is the commonest cardiac arrhythmia, regular SVT's~     are also common. The two commonest regular SVT's are atrioventricular (nodal) reentry~     tachycardias (AV(N)RT) and atrial flutter (AFL). Atrioventricular (nodal) reentry~     tachycardias (AV(N)RT) are common but benign forms of fast heart rhythm. Although AV(N)RT can~     cause unpleasant symptoms and are frightening it is not dangerous. If patients present with~     AV(N)RT the accepted and normal treatment for most is to have the fast heart rhythm stopped~     by either taking a deep breath and straining or by the use of drugs. Patients can then be~     discharged home and have further investigation and treatment as an outpatient. SVT can be~     frightening for the patient but is easy to diagnose and treat. There is high success rate~     post treatment for this benign condition. This is traditionally done in the local accident~     and emergency, although patients can sometimes be unnecessarily admitted to hospital~     overnight. We propose to investigate the safety and efficacy of training paramedics to treat~     safe forms of AV(N)RT at the scene and then giving the patient an information pack which~     includes a request for a GP referral to a heart rhythm specialist. Patients will be randomly~     allocated after consenting to take part in the study to either get paramedic or accident and~     emergency department treatment. We will compare these two approaches by telephone follow up~     of the patients. The costs of the different approaches will be compared by assessing the rate~     of appropriate investigation and the information given to patients and how they rated their~     experiences.~   "
103226|NCT02216227|"~     The goals of this project are 1) to assess the effectiveness and cost-effectiveness of the~     checklist to prevent MRSA SSIs among Veterans undergoing TJA or cardiac surgery, and 2) to~     assess barriers and facilitators to checklist implementation.~      Hypotheses:~        1. The SSI checklist will be effective at reducing MRSA SSIs among total joint arthroplasty~          and cardiac surgery patients.~        2. Implementation of the checklist will be associated with an overall reduction in SSIs~          caused by all pathogens.~        3. The SSI Checklist will be cost-saving since it will prevent many expensive SSIs.~        4. Preoperative MRSA testing will be a modifiable barrier to implementing the SSI~          checklist.~   "
103227|NCT02216214|"~     The purpose of this study is to assess the efficacy, safety and tolerability of mirabegron~     versus placebo in the treatment of older adult subjects with OAB.~   "
103228|NCT02216201|"~     The main purpose of this study is to evaluate whether SUDOSCAN is a valid, accurate clinical~     device for the the determination of sweat gland function in the pediatric population.~      Primary Objective: To measure sweat gland function in a pediatric population~      Secondary Objective: To determine thresholds on the SUDOSCAN scale for abnormal sweat gland~     function in the pediatric population~   "
103229|NCT02216188|"~     This is a follow-up study to assess safety and clinical activity of continued AFFITOPE® PD01A~     vaccinations in patients with Parkinson's disease. Patients, who have already participated in~     AFF008 will be involved and will be receive one boost immunization with AFFITOPE® PD01A. One~     study site in Vienna (Austria) will be involved.~      In addition, up to 8 patients will be offered participation within an untreated control~     group.~   "
103230|NCT02216175|"~     Allergy to cow's milk is the most common food allergy affecting children. There is currently~     no accepted routine clinical therapy to cure milk allergy. Recently studies have attempted to~     induce desensitisation using small daily doses of cow's milk, predominantly by the oral route~     (oral immunotherapy, OIT). Although this therapy works for some people, its effects are not~     generally long lasting and it is associated with significant side effects during protocol,~     including potentially life-threatening allergic reactions.~      Pilot data suggests that sublingual immunotherapy (SLIT, where allergen is held under the~     tongue, rather than swallowed) can also induce a degree of desensitisation, but with fewer~     adverse events. However, the degree of desensitisation induced appears to be lower than that~     with oral immunotherapy.~      The investigators wish to determine whether a sublingual pretreatment phase can improve the~     safety of conventional OIT in cow's milk allergy.~   "
103231|NCT02216162|"~     PROACTIVE randomized study to evaluate the impact of a multidimensional geriatric~     intervention on treatment compliance, measured regularly by blood dosing of drug metabolites.~      Patients in the intervention group will be proposed:~        -  A regular geriatric follow up including an attentive screening of joint symptoms and~          functionality,~        -  An adapted treatment of join pain,~        -  Weekly sessions of adapted physical activity (Taï Chi),~        -  And a systematic correction of vitamin D deficits.~   "
103232|NCT02216149|"~     Fluoropyrimidine chemotherapy agents , such as 5-fluorouracil and capecitabine, are~     occasionally associated with cardiac toxicity. Clinical fluoropyrimidine cardiotoxicity is~     infrequent, but subclinical toxicity may be much more common. Cardiac toxicity may be less~     frequent with S-1 as compared with 5-fluorouracil and capecitabine, but head-to-head~     comparisons are lacking. The purpose of the study is to compare 2 measures of subclinical~     coronary artery microvascular dysfunction, the coronary flow reserve and the coronary flow~     response to a cold pressor test, in a patient population who are being treated for~     adenocarcinoma of the gastrointestinal tract with one of 2 oxaliplatin-containing regimens,~     either with oxaliplatin plus S-1 or with oxaliplatin plus capecitabine.~   "
103233|NCT02216136|"~     This is an observational study of 3 arms: breast conservation therapy (Group A), mastectomy~     and reconstruction (Group B), and mastectomy only (Group C).~   "
103258|NCT02215811|"~     This is a multi-center, open-label, non-randomized controlled trial. Patients with~     viral-induced acute respiratory distress syndrome (ARDS) on extracorporeal membrane~     oxygenation (ECMO) will be eligible. Ten patients will be enrolled and receive allogeneic~     bone marrow-derived mesenchymal stromal cells (BM-MSC). Ventilator parameters as well as~     preoperative clinical characteristics and postoperative clinical outcomes will be registered.~     Routine blood sampling, radiography, and bronchioalveolar lavage will be performed pre- and~     postoperatively. Spirometry, quality of life assessment, and 6 minute walk test will be~     performed postoperatively. All available data will be collected prospectively. Follow-up is~     12 months. Informed consent will be obtained from relatives to patients meeting the inclusion~     criteria before the initiation of any study-specific procedures.~   "
103722|NCT02209714|"~     The objective of the study is to obtain information about the safety and tolerability of BIIF~     1149 BS45 (single dose: 40, 65, 100 mg), to determine the pharmacologically active dose~     (range) by performing a citric acid challenge test and to obtain preliminary pharmacokinetic~     data.~   "
103234|NCT02216123|"~     This is a prospective, double-blind, double-dummy, multicenter, comparative study. A total of~     300 subjects will be randomized to treatment on Day 1, of which a minimum of 50 female~     subjects must be enrolled that display moderate glucose-6-phosphate dehydrogenase (G6PD)~     deficiency (>=40% - <70% of the site median G6PD value). Subjects must have a blood smear~     that is positive for P. vivax at entry. Subjects will be randomized 2:1 to receive~     tafenoquine (TQ)/chloroquine(CQ) or the active comparator primaquine (PQ)/CQ. All subjects~     will receive CQ on Days 1 to 3, followed by TQ or PQ and matching placebo beginning on Day 1~     or 2. Tafenoquine, or matching placebo, will be given as a single, 300mg dose. Subjects will~     receive PQ (15mg once daily) or matching placebo for 14 days. The duration of the study is~     180 days, including screening and randomization to treatment (Day 1), three in-hospital days~     (Days 1-3), four out-patient visits while on treatment with study medication (Days 5, 8, 11~     and 15) and seven follow-up visits (Days 22, 29, 60, 90, 120, 150 and 180).~      The primary safety data collected in this study will help to understand the hemolysis risk to~     both G6PD-normal and G6PD-deficient subjects. The efficacy data produced from this study will~     support the results for sister study TAF112582, the pivotal phase III efficacy and safety~     study of the TQ program.~   "
103235|NCT02216110|"~     Gastrectomy is curative treatment for early gastric cancer (EGC). Recently, endoscopic~     submucosal dissection (ESD) has been accepted as standard treatment in selected patients with~     negligible risk of lymph node metastasis. However, there are limited data regarding the~     long-term outcomes of ESD in comparison with surgery. This protocol aims to compare overall~     survival rate, tumor recurrence, development of metachronous cancers after ESD and surgery.~   "
103236|NCT02216097|"~     The purpose of the study is to evaluate proof of mechanism of PF-04457845, using a~     well-established neuroimaging paradigm including behavioral tasks selected to activate~     neuro-circuitry relevant to Post Traumatic Stress Disorder. It is hypothesized that~     PF-04457845 will modulate the Blood-oxygen-level dependent Functional Magnetic Resonance~     Imaging signal from the relevant neuro-circuits in patients with Post Traumatic Stress~     Disorder.~   "
103237|NCT02216084|"~     The purpose of this Phase 1, prospective, uncontrolled, open-label, multicenter,~     dose-escalation study is to evaluate the safety, including immunogenicity, and~     pharmacokinetics of BAX930 (rADAMTS13) in a total of 14 evaluable subjects diagnosed with~     severe hereditary thrombotic thrombocytopenic purpura (TTP) (plasma ADAMTS13 activity <6%)~     who are assigned to one of three dose cohorts.~   "
103238|NCT02216071|"~     The purpose of the study is to demonstrate the clinical therapeutic non-inferiority of EXL~     CDOS to commercially available Ciprofloxacin 0.3% and Dexamethasone 0.1% Sterile Otic~     Suspension (Ciprodex®, Alcon) in the treatment of acute otitis externa (AOE) when~     administered twice daily for 7 days.~   "
103239|NCT02216058|"~     A prospective, multicenter study is preformed to evaluate the safety and efficacy of NOYA~     CoCr biodegradable coating sirolimus-eluting stents in treating coronary artery lesions.~   "
103240|NCT02216045|"~     Camel milk as the new modality for treatment of chronic hepatitis C. The purpose of this~     study is to evaluate effectiveness and safety of camel milk in combination with Peginterferon~     Alfa-2a and Ribavirin in genotype 2,3 chronic hepatitis C virus .~   "
103241|NCT02216032|"~     Thirty Million Words Home Visiting: A Longitudinal RCT is a longitudinal, randomized control~     trial, which is required to confirm whether the parent behavior changes seen during the~     feasibility trial are sustainable, and, critically, whether those changes translate into~     positive impacts on child language outcomes, child social-emotional development, and~     subsequent school readiness. The investigators will deliver the Thirty Million Words (TMW)~     Curriculum to 100 Treatment families, and the investigators will be following the children~     through kindergarten in order to measure the effects and sustainability of the curriculum.~     The investigators will deliver a Nutrition Curriculum to 100 Control families in order to~     control for the possible attentional effects experienced by those in the Treatment group.~     Moreover, as an ethical consideration, the investigators wish to also provide families in the~     Control condition with valuable education that may enhance their children's development.~      The investigators hypothesize that the primary effects of the TMW Intervention will~     significantly 1) improve low-SES parents' understanding of the importance of parent language~     in a child's development, 2) increase parents' linguistic interaction, responsiveness, and~     overall engagement with their children, and 3) increase children's language output.~     Furthermore, the investigators hypothesize that increased parental interaction will result in~     4) an improvement in children's social-emotional development. Finally, the investigators~     hypothesize that these social-emotional and linguistic gains through early development, along~     with sustained increased parental engagement, will be expressed in 5) increased child school~     readiness upon kindergarten entry.~   "
103242|NCT02216019|"~     In septic patients, Septiflux1 study identified immature granulocytes which may have a~     diagnostic and prognostic interest. However, with these preliminary results it is not~     possible to make a difference between what is linked to the infection and what is a~     consequence of the inflammation which goes along with the septic process. Using flow~     cytometry, the study of leukocytes in a pure inflammatory model such as cardiopulmonary~     bypass in heart surgery could make possible to test the diagnostic interest of the immature~     granulocytes but also to attribute a prognostic value for the occurrence of post-operative~     infections.~   "
103243|NCT02216006|"~     Atelectasis is common during and after general anesthesia. Atelectasis develops early if~     preoxygenation with 100% oxygen is used and continuously used during induction until~     endotracheal intubation. The investigators hypothesize that a rapid anti-preoxygenation~     maneuver immediately after confirming a successful intubation, reduces the area of~     atelectasis as investigated by computed tomography compared to a standard procedure.~   "
103244|NCT02215993|"~     Introduction:~      Platelet aggregation plays an important role in ischemic complications in patients undergoing~     to percutaneous coronary intervention (PCI). The addition of clopidogrel, as a second~     antiplatelet agent, to acetylsalicylic acid (ASA) was effective in reducing major~     cardiovascular events in patients with acute coronary syndrome (ACS).~      However, approximately 30% of ACS patients are resistant to clopidogrel, representing a~     population of medically vulnerable and high risk for major cardiovascular events, including~     myocardial infarction (MI), stent thrombosis and death.~      In the randomized trial TRITON, prasugrel compared to clopidogrel was more effective in~     significantly reducing the rates of MI (7.4% vs. 9.4%) and stent thrombosis (2.4% vs .1,1%)~     in patients with ACS, however, patients treated with prasugrel showed higher rates of~     bleeding (2.4 vs. 1.8%) and no difference in mortality. Upon analysis of subgroups is not~     recommended its use in patients with a history of stroke in those older than 75 years and~     weighing less than 60 kg.~      The latest class of inhibitors of the P2Y12 receptor is the cyclopentyl-triazolopyrimidines~     represented by ticagrelor. Unlike the thienopyridines, ticagrelor interacts with the platelet~     receptors in a reversible way and has a beginning and peak of action faster.~      The efficacy and safety of ticagrelor were evaluated in the study PLATO, where 18.624~     patients with ACS were randomized to receive clopidogrel (75mg/day, with a loading dose of~     300 to 600mg) or ticagrelor (90mg 2x/day with a loading dose of 180mg) The primary combined~     endpoint (mortality from vascular causes, MI or stroke) at 12 months was significantly lower~     in the ticagrelor (9.8% vs. 11.7%). There was no significant difference in the rates of major~     bleeding in both groups. Moreover, the isolated analysis of the rates of MI, vascular~     mortality and mortality from all causes showed statistically significant reduction in the~     ticagrelor users. In this study, the main adverse effects were dyspnea and bradycardia.~      The assessment of platelet reactivity may allow the individualization of antiplatelet~     therapy. However, simply increasing the dose of clopidogrel in patients who persisted with~     high platelet reactivity was not able to reduce the combined endpoint of cardiovascular~     death, nonfatal myocardial infarction and stent thrombosis in six months.~      In a population of patients with stable coronary artery disease, the substitution of~     clopidogrel for ticagrelor showed a rapid and persistent decrease in platelet aggregation~     measured by different laboratory methods. However, in patients with ACS subjected to PCI, the~     assessment of platelet aggregation after the replacement of clopidogrel for prasugrel or~     ticagrelor still requires evidence.~      Objectives:~      To evaluate the platelet response to ticagrelor and prasugrel in ACS patients with ST-segment~     elevation submitted to thrombolysis.~      To evaluate security in follow up of 30 days.~      Methods:~      The study will be a prospective, randomized, single-center (São Paulo Hospital - Federal~     University of São Paulo), single-blind. The investigators will select 50 patients admitted~     with ACS with ST-segment elevation submitted to thrombolysis and who underwent cardiac~     catheterization between 3 to 24 hours in the case of reperfusion or immediately for rescue~     angioplasty. Blood sample for analysis of platelet aggregation through the system VerifyNow~     ®, shall be obtained immediately after the procedure on patients on clopidogrel for at least~     seven days in maintenance dose of 75mg or after 8 to 6 hours after the dose of 300mg and~     600mg respectively. Patients will be randomized in a 1:1 ratio to receive ticagrelor the dose~     of 180mg and maintained dose of 90 mg twice a day for thirty days or prasugrel dose of 60mg~     and maintained for thirty days at a daily dose of 10mg. A new blood sample and analysis of~     platelet aggregation will be repeated after 2, 6 and 24 hours. The demographic and clinical~     data of this population will be collected in specific form and stored in databases for later~     analysis~   "
103245|NCT02215980|"~     This protocol is a phase III multicenter, randomized, controlled study designed to assess the~     safety and the efficacy of standard schedule versus a new algoritm of dose reductions in~     elderly and unfit newly diagnosed Multiple Myeloma (MM) patients receiving lenalidomide plus~     steroids.~   "
103339|NCT02214758|"~     The aim of the study is to evaluate the impact of six month long nutritional and oral health~     intervention on nutritional status, oral health, functional performance and hospital~     admission/costs on older persons using home care services. Additionally, participants are~     interviewed at home regarding their drugs use and this information will be compared with~     medication information in electronic patient records.~   "
103246|NCT02215967|"~     Background:~      - T cells are white blood cells that fight several cancers. One cancer therapy involves~     removing a person s T cells, changing them in a lab, and then returning them to the person.~     Researchers want to see if this helps people with multiple myeloma.~      Objective:~      - To test the safety of giving anti-B-Cell Maturation Antigen T cells to people with multiple~     myeloma.~      Eligibility:~      - Adults ages 18 70 with multiple myeloma that has not responded to standard therapies.~      Design:~        -  Participants may be screened with:~        -  Medical history~        -  Physical exam~        -  Blood and urine tests~        -  Heart tests~        -  Bone marrow sample~        -  Multiple scans and X-rays~        -  Participants will have apheresis. Blood is removed through a needle in an arm. T cells~          are removed. The rest of the blood is returned through a needle in the other arm.~        -  The cells will be changed in a laboratory.~        -  Participants will get 2 chemotherapy drugs over 3 days.~        -  Two days later, participants will check into the hospital. They will get an intravenous~          (IV) catheter in an arm or chest vein. They will get the T cells through the IV in 1~          infusion.~        -  After this, participants will stay in the hospital for at least 9 days and stay nearby~          for 2 weeks. Then they will have blood tests and see a doctor.~        -  Participants will visit the clinic 1, 2, 3, 4, 6, and 12 months after the infusion, then~          every 6 months. A bone marrow sample will be taken at the 2-month visit.~        -  Participants blood will be collected for several years. Participants will have an annual~          physical at NIH for 5 years after the infusion. Then for 10 years they will answer~          health questionnaires.~   "
103247|NCT02215954|"~     To demonstrate non inferiority of a) FE 999169 Split Dosing Schedule (one dose on the day~     before and the second dose on the day of colonoscopy) and b) FE 999169 Day Before Dosing~     Schedule (two doses on the day before colonoscopy) to  Niflec On the Day Dosing Schedule~     in subjects requiring colonoscopy.~   "
103248|NCT02215941|"~     The primary objective of this study is to characterize the pharmacokinetics of TV-45070 in~     plasma following single and multiple-dose topical application of 8% TV-45070 ointment.~   "
103249|NCT02215928|"~     This research trial studies using genomic profiling to recommend anticancer treatment to~     patients with cancer that has spread beyond the original site of the tumor (metastatic~     cancer). Genomic profiling studies the deoxyribonucleic acid (DNA) of a tumor to detect~     genetic changes or abnormalities. This information can then be used to recommend treatments~     that may be more likely to result in a beneficial response. It is not yet known whether~     genomic profiling will detect abnormalities that can be used to make treatment~     recommendations and whether treatment based on genomic profiling is more effective than~     standard treatment.~   "
103250|NCT02215915|"~     A number of 1448 patients scheduled for elective percutaneous coronary intervention (PCI)~     with a native coronary stenosis suitable for DES implantation and IVUS imaging are openly~     randomized 1:1 to either IVUS guidance or angiographic guidance groups.~   "
103251|NCT02215902|"~     Primary Objectives:~      To demonstrate the safety of the Aethlon Hemopurifier® when used in extracorporeal blood~     purification.~      Secondary Objectives:~      To quantify the number of viral copies captured by the Aethlon Hemopurifier® during the first~     and last Hemopurifier treatments using elution methods developed by Aethlon Medical Inc.~      To measure changes in viral load in patients before and after treatment with the Aethlon~     Hemopurifier®.~   "
103252|NCT02215889|"~     The patients will receive hepatectomy as a 2 stage procedure. In the first surgical procedure~     liver segments 2-3 are removed and liver donor segments 2-3 inserted. After growth of donor~     segments 2-3, the remaining liver segments of the recipient are removed. The patient will at~     this time have only donor liver tissue in place.~   "
103253|NCT02215876|"~     This is a phase II, single institutional study, to evaluate a novel neo-adjuvant regimen in~     patients with operable, HER2-negative, breast cancer.~   "
103254|NCT02215863|"~     Recent reviews have highlighted the unpredictability and complexity of immune interference~     when multivalent conjugate vaccines are co-administered with other pediatric vaccines. It has~     become evident that the likelihood of immune interference (in response to conjugated- or~     co-administered antigens) increases in proportional to the number of glyco-conjugates~     (valencies) and dosages of carrier proteins. There are many kinds of carrier proteins:~     tetanus toxoid (TT), diphtheria toxoid (DT), CRM197 (non-toxic variant of DT), OMP (complex~     outer-membrane protein mixture from Neisseria meningitidis) and non-typeable Hemophilus~     influenza-derived protein D. Among them, TT is a more potent inducer of T-helper immunity,~     but carrier-induced-epitopic suppression (dose-dependent carrier antibody and carrier B cell~     dominance) may occur with TT. In comparison, DT and CRM197 are weaker B-cell immunogens, but~     apparently trigger more T-regulatory mechanism. Recent pediatric studies of PCV13~     co-administered with DTaP vaccines showed 6B GMT (geometric mean titer) to be somewhat~     reduced compared to the results with PCV13 alone.~      Similar to children, adults frequently visit outpatient clinics to get two or more kinds of~     vaccines at the same time: pneumococcal vaccine, influenza vaccine, Td (diphtheria and~     tetanus) vaccine, HPV (human papilloma virus) vaccine, meningococcal vaccine, zoster vaccine,~     etc. PCV13 has limited co-administration information for adjuvanted influenza vaccine.~      This study is designed to evaluate the immunogenicity and safety of PCV13 and MF59-adjuvanted~     influenza vaccine (Fluad) after concomitant administration in adults aged 60 years or older.~   "
103255|NCT02215850|"~     SLC-0111 is a selective, small molecule, inhibitor of carbonic anhydrase (CA) IX and is in~     development for the treatment of solid tumours over-expressing CA IX. CAIX, a transmembrane~     metalloenzyme, is overexpressed on extracellular surfaces of hypoxic tumour cells but its~     expression is highly restricted in normal tissue. CAIX is a functional regulator of processes~     critical for tumour growth and metastasis, including pH regulation, survival, migration and~     invasion.~      This prospective single arm study will evaluate the safety of SLC-0111 given once daily in 28~     day cycles in subjects with advanced solid tumours. The intent of this research study is to~     find our more information such as: the highest dose of SLC-0111 that can be given safely, the~     side effect it may cause, to examine how the body affects the study drug concentration in the~     blood (pharmacokinetics or PK), and to gain some information on its effectiveness in treating~     cancer.~   "
103256|NCT02215837|"~     The purpose of this study is to evaluate the safety and efficacy of chemotherapy combined~     with autologous tumor Lysate-pulsed dendritic with cytokine-induced killer cell (Ag-D-CIK)~     for gastric cancer.~   "
103259|NCT02215798|"~     Primary objective: To estimate the frequency of adverse events, serious and non-serious in~     Filipino patients with diabetic peripheral neuropathic pain treated with duloxetine 60mg once~     daily within the study duration of approximately 6-8 weeks in a naturalistic clinical~     setting. Secondary objective: To evaluate the change from baseline to endpoint in the Brief~     Pain Inventory (BPI) and Neuropathic Pain Questionnaire (NPQ) assessed by the investigators~     in duloxetine use in the treatment of diabetic peripheral neuropathic pain among Filipino~     patients within the study duration of approximately 6-8 weeks in a naturalistic clinical~     setting.~   "
103260|NCT02215785|"~     Constipation is a symptom suffered by a large number of people, due to multifactorial causes.~     Some studies have proven that modifying lifestyle reduces the risk of constipation, with~     high-fibre diets being less prone to constipation. Kiwifruit consumption, improves functional~     constipation and some studies consistently report an increase in the frequency and ease of~     defecation, stool volume and softness.~      Although literature suggests kiwifruit consumption improves constipation symptoms, no studies~     have been carried out in adults and in Mediterranean patient populations, characteristic for~     its differential nutritional habits. The aim of the present study was to test the effect of~     kiwifruit consumption on functional constipation in a Spanish adult population.~   "
103261|NCT02215772|"~     Study to investigate the basic pharmacokinetics of BI 44370 BS, its metabolite CD 10419 BS,~     and 14C-radioactivity including mass balance, excretion pathways, and metabolism following a~     single oral administration of 200 mg [14C]BI 44370 BS to healthy male volunteers and to~     evaluate safety and tolerability following a single oral administration of 200 mg [14C]BI~     44370 BS to healthy male volunteers~   "
103262|NCT02215759|"~     Evaluation of safety, tolerability and pharmacokinetics of multiple rising oral doses of BI~     44370 TA in healthy male and female volunteers~   "
103263|NCT02215746|"~     The objective of this trial was to evaluate the relative oral bioavailability and~     pharmacokinetics of BI 44370 TA drinking solution (100 mg and 200 mg) and BI 44370 TA tablets~     (100 mg as two 50 mg tablets) with and without a high fat meal and to assess the safety and~     tolerability of the substances.~   "
103264|NCT02215733|"~     The primary objective of this study was to assess whether angiotensin blockers (ARBs) and~     telmisartan in particular, are associated with an increased overall risk of the four most~     common cancers, namely, lung, colorectal, breast and prostate cancers. A secondary objective~     was to explore these effects separately for each of the four cancers and in combination with~     angiotensin-converting-enzyme-inhibitors (ACEIs).~   "
103265|NCT02215720|"~     Cetuximab is an EGFR inhibitor that has shown efficacy alone or in combination in colorectal~     cancer or head and neck cancer in several phase II/III studies.~      Temsirolimus is a new mTOR inhibitor that has shown interesting results in several Phase I/II~     studies in advance kidney cancer of bad prognosis.~      Study hypothesis is that combination of those two compounds and the inhibition of two~     pathways at the same time will have more efficiency on tumoral growth than the inhibition of~     those pathways in isolation.~   "
103266|NCT02215707|"~     This is an open-label evaluation of the safety, tolerability immunogenicity and efficacy of~     the PfSPZ Vaccine administered by Direct Venous Inoculation (DVI) in healthy, malaria-naïve~     subjects. There will be 3 groups and a total of 69 subjects (45 immunized subjects and 24~     infectivity controls).~   "
103267|NCT02215694|"~     The purpose of this study is to evaluate the effect of dual probiotic strains containing~     Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032 on triglyceride and~     apolipoprotein A-V.~   "
103268|NCT02215681|"~     Objective: to evaluate acupunctures effect on inflammatory markers in pediatric Otitis Media~     with Effusion Methods: 100 Children with otitis media with effusion (OME) diagnosis, who are~     in watchful waiting for 3 month, will be randomized in two groups: acupuncture and control.~     50 Children in the acupuncture group will receive standard treatment combined with~     acupuncture for 3 months. 50 Children in the control group will receive standard treatment~     only, for the same time period. After 3 months, both groups will be reassessed for OME.~     Children with no improvement from both groups will be assigned for tympanostomy.~      Data collection: in children undergoing tympanostomy, middle ear effusion (MEE) will be~     collected, analyzed and evaluated for group differences.~   "
103269|NCT02215668|"~     Mammography is a systematic way in the main programs of screening for breast cancer in women~     over 40 or 50 years old, according to screening programs, but most research has shown a~     frequency of discomfort and pain during the examination mammography. This study is a~     randomized controlled trial, whose intervention will be a sequence of exercises body warming~     and muscle stretching, performed systematic manner and supervised by a physical educator. It~     is expected to find in this study a possible impact of physical exercise in reducing pain~     after mammography examination.~   "
103270|NCT02215655|"~     Hyperphosphatemia in end-stage renal disease (ESRD) patients is a non-traditional risk factor~     for all-cause and cardiovascular mortality. Non-adherence to phosphate binders is as high as~     74% in ESRD patients and has been shown to be most related to psychosocial factors including~     attitudes. There is limited data on the influence of attitudes and perceived autonomy support~     on phosphate binder adherence and these two psychosocial constructs can be positively~     influenced through the use of motivational interviewing skills to increase autonomous~     motivation. Furthermore, racial disparities are known to exist in ESRD however and there are~     still gaps, which exist in understanding the determinants of disparities in adherence in~     vulnerable patients with ESRD.~      In this study, the investigators seek to determine the impact of motivational interviewing on~     phosphate binder adherence in diverse ESRD patients. The investigators will ask all the~     subjects to fill out surveys mainly regarding their attitudes; perceived providers' autonomy~     support and phosphate binder adherence. The investigators will administer motivational~     counseling to subjects in the intervention arm of the study, at baseline and 1 month after~     recruitment. The investigators will ask all the subjects to fill out the same surveys 2~     months after recruitment and the investigators will compare subjects who underwent~     motivational interviewing to those who did not.~   "
103340|NCT02214745|"~     To evaluate the demographic characteristics of patients suffering from mental retardation or~     cerebral palsy in the Israeli Arab community. Specific questionnaires will be developed and~     will be distributed amongst this population in order to identify these characteristics.~   "
104840|NCT02195089|"~     The purpose of this study is to determine the efficacy and the safety of BLS-ILB-E710c for~     the the fertile women with Cervical Intraepithelial Neoplasia (CIN3).~   "
103271|NCT02215642|"~     Colorectal cancer incidence is increasing at an alarming rate in China. Recent reports~     concluded nutrition status and lifestyle factors were associated with colorectal cancer risk,~     however, the influence of nutrition and lifestyle factors on cancer outcome in colorectal~     cancer survivors is largely unknown.The investigators will explore the impact of nutrition~     status, life style, dietary pattern, obesity, physical activity, depression, diabetes,~     aspirin use and vitamin supplement on colorectal cancer outcome. The investigators will~     recruit approximately 50,000 patients as a prospective study cohort. During follow up, the~     investigators will explore the association of these factors with disease-specific survival,~     disease-free survival and overall survival of patients. The investigators believe that this~     project will facilitate the establishment of domestic nutrition and lifestyle data of~     colorectal cancer of China, and the improvement of the quality of clinical management of~     patients with colorectal cancer.~   "
103272|NCT02215629|"~     The main purpose of this study is to test the safety and efficacy of VS-4718 in two types of~     leukemia patients and to find the right dose of VS-4718 for future clinical trials.~      Other purposes of this study include:~        -  Testing for study drug VS-4718 levels in blood over time and what happens to the study~          drug in patients.~        -  To find out if there are certain biomarkers in leukemia patients that predict if and how~          4718 study drug may or may not work.~   "
103273|NCT02215616|"~     The primary objective of this study is to assess the efficacy of laquinimod 0.5, 1.0, and 1.5~     mg qd in patients with HD after 12 months of treatment using the UHDRS-TMS.~   "
103274|NCT02215603|"~     Great controversy exists with respect to the optimal or the minimum volume, intensity, and~     frequency of physical activity capable of attenuating the hazards of prolonged sitting on the~     metabolic profile. Thus, our study aims to comprehensively investigate the effects of~     disrupting prolonged sitting with different physical activity protocols on metabolic risk~     factors in sedentary males.~      Ten sedentary males will take part in this randomized cross-over trial consisting of four~     27-h conditions. All conditions will be identical except for the physical activity: prolonged~     sitting intervention (SIT) participants will sit continuously for 9 hours; prolonged~     sitting+interval standing intervention (STAND), participants will stand for 15 min every 30~     minutes (total 270 min) during the 9 hours of sitting; prolonged sitting+moderate-intensity~     exercise bout (MVPA) participants will perform a 30-min moderate-intensity exercise bout on a~     treadmill (energy-matched to STAND), after which they will sit for the remaining time; and~     prolonged sitting+moderate-intensity exercise bout +interval standing intervention~     (MVPA-STAND), participants will perform a 30-min moderate-intensity exercise bout on a~     treadmill (energy-matched to STAND), after which they will stand for 15 min every 30 minutes~     (total 240 min) during the remaining 8 hours of sitting. Blood glucose, insulin, lipids and~     cytokines will be determined.~      The investigators expect that disrupting prolonged sitting with intermittent standing and a~     moderate-exercise bout will positively affect the metabolic profile of the participants.~     Furthermore, we will investigate if combined, these strategies will have an additive effect.~   "
103275|NCT02215590|"~     The purpose of this study is to:~        1. Test the walking functionality of people following Acquired brain injury (ABI)~        2. Suggesting a new treatment for their walking impairments~        3. Follow-up of motor learning ability and balance after intervention within this~          population~      The investigators intend to target dynamic stability and gait after ABI, in a group of~     individuals with ABI who have persistent balance and mobility deficits despite being able to~     walk independently and having high scores on standard clinical balance measures.~      Interventions: Training with Re-Step system shoes.~      In this study there is no control group.~   "
103276|NCT02215577|"~     Study Title Comparison of two different models of liver growth stimulation in advanced~     colorectal liver metastatic disease, (LIGRO Trial) enabling liver resection~      Methodology Scandinavian Multiple Center Randomized Registry Based Clinical Trial~      Study duration The planned duration of study participation for an individual subject from~     inclusion to follow-up are 3 years~      Primary investigator:~      Per Sandstrom (Linköping)~      Number of subjects 100 patients randomized in a 1:1 randomization~      Diagnosis and main inclusion criteria Patients with colorectal liver metastasis requiring~     liver resection, but are not resectable in one step because of a future liver~     remnant/standardized total liver volume of < 30 % extrahepatic metastatic disease is not an~     exclusion criteria if they can be addressed surgically in the future~      Overall goal To evaluate if the ALPPS approach is superior to PVE in enabling patients,~     primarily unresectable due to inadequate FLR, to be resected and reach an R0 situation with~     an acceptable level of complications and perioperative mortality.~      To evaluate if the ALPPS approach increases the growth rate of the liver compared to portal~     embolization or portal ligation leading to a shorter treatment period.~      In addition the investigators aim to study if ALPPS may reach these goals without detectable~     or improved differences in tumor activity (PFS and OS), but with a shorter recovery and a~     higher proportion of patients reaching R0.~      Hypothesis A higher proportion of patients can be resected with ALPPS counted as rate~     resected compared to the previously established methods with portal ligation or embolization.~      This increased resection rate will not reduce the R0 rate, or increase the rate of Clavien~     grade 4 complication or higher (H0).~      The ALPPS approach will increase the growth rate compared to portal embolization/ligation~     measured one week after the primary intervention.~   "
103277|NCT02215564|"~     The objective in this observational cohort study of young adults sampled at three intervals~     during the academic year is to ascertain if there is carriage of B. pertussis in asymptomatic~     individuals. We hypothesize that in asymptomatic college students there is no carriage of B.~     pertussis detectable by polymerase chain reaction (PCR) assay.~   "
103278|NCT02215551|"~     Decompressive laminectomy (DL) is the most common type of back surgery performed in older~     adults; DL treats lumbar spinal stenosis (LSS), a degenerative narrowing of the spinal canal~     causes pain and trouble walking. An estimated one in three people who undergo DL do not get~     well and often undergo repeated surgery.1,3-6 Some studies indicate that conditions outside~     of the spine (e.g., depression, hip arthritis) cause people who undergo DL to do~     poorly,27,30-36 but no one has comprehensively examined these conditions or the impact of~     treating them on DL outcomes. Thus LSS treatment continues to focus on the spine alone.61 The~     aim of this study is to identify conditions other than LSS that place Veterans at risk of~     poor DL outcomes so that future comparative effectiveness studies can be designed that~     examine the impact of a more comprehensive approach to treatment. Investigators believe that~     a patient-centered rather than a disease-centered approach will lead to superior outcomes,~     less suffering, and more appropriate use of health care resources.~   "
103356|NCT02214537|"~     The embryokinetics may be a new prognostic factor for choosing the human embryos with the~     highest implantation potential. In order to identify the factors that may affect the rate of~     embryo cleavage, there are many studies about morphokinetics and culture medium, oxygen~     tension, oocyte quality or type of medication used for ovarian stimulation. However there are~     no published data with respect to the influence of sperm DNA fragmentation in the embryo~     kinetic.~   "
103279|NCT02215538|"~     This study will look at the effectiveness of osmotic release oral system (OROS)~     methylphenidate (Concerta) in treating attention deficit hyperactvity disorder (ADHD) in~     adults. Concerta has received FDA approval for childhood ADHD and there is documentation that~     it is effective in adult ADHD. However this trial will explore its effectiveness in treating~     symptoms not a part of the Diagnostic and Statistical Manual-III (DSM-III) criteria. Subjects~     will experience one screening visit and one baseline visit. Those who meet admission criteria~     will enter the double-blind phase. This will involve two 4-week treatment periods one of~     which will involve the use of Concerta and the other a placebo pill. Subjects who complete~     the double-blind phase will be allowed to enter a 180-day, open-label Concerta phase designed~     to assess long-term effects.~   "
103280|NCT02215525|"~     A Randomized, Open-Label, Study to evaluate and compare the efficacy and safety, of~     extracorporeal irradiation of circulating blood by UVA with antioxidant as a supplement~     (Selenium containing food supplement herbal tablets) in the treatment of non-cirrhotic~     subjects with chronic hepatitis C.~   "
103281|NCT02215512|"~     In this dose-escalation study, the safety and tolerability of escalating dose levels of~     RRx-001 administered intravenously twice a week in subjects with brain metastases receiving~     whole brain radiation therapy (WBRT) will be assessed. Once a maximum tolerated dose is~     identified, further (up to approximately 30) participants will be recruited. The study will~     use MRI to monitor changes in tumor blood flow associated with RRx-001.~   "
103282|NCT02215499|"~     This study is being conducted to evaluate the safety, tolerability, blood distribution and~     effectiveness single ascending doses of JZP-386 compared to doses of Xyrem® and placebo.~   "
103283|NCT02215486|"~     The autonomic nervous system (ANS) unconsciously regulates the activities of vital organ~     systems such as the respiratory, circulatory, and urinary systems. It consists of two major~     components, the parasympathetic nervous system (PNS) and the sympathetic nervous system~     (SNS), which together are in charge of keeping our body in homeostasis. Homeostasis is the~     state of chemical and metabolic balance within an organism; it is disturbed in situations of~     uncontrolled stress.~      Massage has been shown to decrease SNS and stimulate PNS; but most studies focused on full~     body massage, with limited assessment of ANS function, and lacked control groups.~      The effects of head massage therapy (HMT) on regulating the activity of the ANS have not been~     studied before. In this pilot study, we propose that by randomizing 10 participants to~     sessions of HMT and 'Simple Relaxation' (no HMT), and by using a non-invasive method of~     measuring the ANS activity (spectral analysis of Heart Rate Variability [HRV] as well as~     Pre-ejection Period (PEP)), we will be able to investigate the effects of 10 minutes of HMT~     in comparison with the period of no HMT administered. We expect HMT to reduce stress, with a~     better and balanced profile of autonomic nervous system after receiving massage.~   "
103284|NCT02215473|"~     Bacteremia represents the presence of live germs in the blood stream. Patients with gum~     disease show damaged tissues and seem to be more susceptible to bacteremia. In fact, daily~     activities such as mastication can induce bacteremia in these patients. Dental procedures~     related to bleeding also induce bacteremia. However, there are many questions that should be~     clarified. Among them, clinical strategies that are able to reduce the levels of germs in~     blood should be determined. This desirable effect could be particularly important for some~     patients, for example, for those at higher risk for endocarditis. Therefore, this study~     tested if 0.12% chlorhexidine solution used as a single mouth rinse before dental~     instrumentation could reduce the levels of bacteria in the blood. In addition, the occurrence~     and magnitude of bacteremia in patients with gum disease were investigated by two different~     laboratorial techniques. After receiving verbal and written explanations and after signed the~     informed consent form, 80 systemically healthy volunteers diagnosed with gum disease having~     dental plaque and tartar were randomly allocated in one the following groups: a) mouth-rinse~     use and dental instrumentation and b) dental instrumentation with no mouth rinse. In a~     preliminary visit volunteers underwent a complete periodontal examination which included~     clinical measurements (inflammatory and debris accumulation indicators), microbial (tongue~     and dental plaque samples collected with paper points), saliva (to determine volume and~     biological indicators) and gingival crevicular fluid sampling (to monitor gingival~     inflammation profile). In the next visit, dental instrumentation was performed under local~     anesthesia, after the mouth rinse single use in the most diseased periodontal teeth/quadrant.~     Blood samples were collected before any dental procedure, 2 and 6 minutes after dental~     instrumentation. Oral hygiene instructions and periodontal treatment were performed in~     additional visits according to individual needs. Finally, the relation between bacteremia and~     several indicators of periodontal status was investigated.~   "
103285|NCT02215460|"~     Periodontitis is a form of gum disease that affects many people in the world. Its traditional~     protocol of treatment includes oral hygiene instruction and dental scaling to remove debris,~     dental plaque and tartar in 4 weekly sections. There is an additional time-reduced option~     also usually cheaper. In this last one, all above described procedures are performed within~     24 hours. However, up to now comparative effectiveness between these both types of treatment~     is not well understood. For, example it is not clear if patients treated in the shorter-time~     experienced more pain. Therefore, the present study used several parameters to clarify~     whether beneficial differences between these therapeutic protocols exist or not. In addition,~     aspects that could help clinicians' and patient's decisions such as experience of pain and~     anxiety related to dental treatment were also investigated. After receiving verbal and~     written explanations and signed the informed consent form 150 individuals (n=15/group) having~     the most common type of periodontitis in adults were randomly allocated to be treated in 4~     weekly sections or within 24 hours. Oral hygiene instructions and dental debridement were~     performed alone or in conjunction with antimicrobial agents: a mouth rinse containing~     chlorhexidine or systemic azithromycin antibiotic tablets. The parameters measured at~     baseline, 3, 6 and 9 months after treatment were: indicators of inflammation, amount of oral~     debris and malodor; quantification of bacteria in plaque samples collected with paper points~     from teeth and tongue; amount of produced saliva and self-reported questionnaires to collect~     information about oral condition, daily activities, pain and anxiety related to dental~     treatment.~   "
103310|NCT02215135|"~     Corifollitropin alfa, single dose administered sustains multiple follicular development for 7~     days. However, It may induce ovarian hyperstimulation syndrome (OHSS), especially in high~     responder women such as patients of polycystic ovary syndrome (PCOS). In GnRH antagonist~     protocol with agonist triggering of final oocyte maturation, following embryo~     cryopreservation can almost eliminate the risk of OHSS. To decrease the injection burden and~     prevent OHSS in PCOS patients undergoing IVF treatment, ovarian hyperstimulation with~     Corifollitropin alfa in GnRH antagonist protocol and GnRH agonist triggering of final oocyte~     maturation, following elective embryo cryopreservation was designed in this study. The~     purpose of this trial was conducted to confirmed whether this novel protocol could prevent~     OHSS, decreased the injection burden of PCOS patients and single dose corifollitropin alfa~     could support multiple follicular growth for 7 days.~   "
103286|NCT02215447|"~     Gastrointestinal Neuroendocrine Tumours (NETs) are gaining increasing recognition as a highly~     prevalent disease, responsive to a number of therapies, some of which are proven in modern~     randomised controlled trials, but many of which still require high quality clinical trial~     evidence to confirm their effectiveness and guide their use in practice. This study is the~     first prospective trial to evaluate modern combination chemotherapy. The study will determine~     whether Carboplatin and Paclitaxel NAB is a suitable combination for comparison in a~     subsequent randomised controlled phase III international trial.~      Given the paucity of randomized studies in NETs, there are no clear evidence based~     guidelines. Patients are treated according to guidelines established for small cell lung~     cancer, incorporating platinum (cisplatin or carboplatin) based doublet treatment with~     etoposide. Although these tumors are initially highly chemosensitive, the natural history of~     this disease is such that relapses occur early, which ultimately leads to a very poor~     prognosis. Almost all clinical trials investigating cytotoxic chemotherapy in NETs are small~     single arm studies and guidelines are derived from expert opinion and from extrapolating~     results from small cell lung cancer studies. Prospective clinical trials in this group of~     patients needs to be conducted to establish an evidence based standard of care and to improve~     the prognosis of this highly aggressive group of tumors.~      Participants will receive albumin bound paclitaxel (ABRAXANE®) 100 mg/m2 administered as an~     intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21 day cycle. Carboplatin~     will be given at an Area Under the Curve (AUC) = 5 mg/min/mL on Day 1 only of each 21 day~     cycle administered over 30 mins, beginning immediately after the completion of albumin bound~     paclitaxel administration. Participants can continue treatment at the investigator's~     discretion until disease progression, development of an unacceptable toxicity, or withdrawal~     of consent.~   "
103287|NCT02215434|"~     Female sexual dysfunction (FSD) is an established side effect of Selective serotonin reuptake~     inhibitors (SSRIs) and serotonin noradrenalin reuptake inhibitors (SNRIs), causing symptoms~     such as loss of libido, arousal difficulties, or delayed orgasm or anorgasmia.~      Efficacy of testosterone therapy for the treatment of hypoactive sexual desire disorder~     (HSDD) in women has been demonstrated in studies including naturally and surgically~     menopausal women, either alone or in combination with estrogen, with or without progestin~     therapy.~   "
103288|NCT02215421|"~     A 20 episode video game called Mommio simulates parent-child feeding interactions for parents~     of 3-5 year old children within a storyline addressing a problem commonly reported by parents~     (getting their 3-5 yo to taste a vegetable, which is often a first step toward eating the~     vegetable), thereby training parents in effective food parenting practices. This research~     evaluates whether the 20 episodes targeting barriers identified by parents across five levels~     of difficulty influences vegetable parenting practices and children's dietary intake. We had~     to discontinue the study since changes in commercial availability of game development~     software required reprogramming and available funding did not allow for completion of game~     programming. Thus, no game evaluation was possible.~   "
103289|NCT02215408|"~     The study tested whether a pharmacist-run cardiovascular risk service (CVRS) at the~     University of Iowa can increase use of national standards of care in clinics~   "
103290|NCT02215395|"~     To evaluate the pharmacokinetics (PK) of EE and NES released from the CVR in the presence of~     a single dose and multiple doses of antimycotic co-medication (miconazole nitrate suppository~     or cream).~   "
103291|NCT02215382|"~     The aim of this study, comparison of effects of sugammadex versus neostigmine/atropine~     combination on hemodynamic parameters and intraocular pressure during tracheal extubation.~      This prospective, randomised study was designed to compare two reversal methods with respect~     to changes in IOP, heart rate and blood pressure during tracheal extubation period.~   "
103292|NCT02215369|"~     The VenaCure EVLT 400 µm Fiber Kit is currently marketed for the treatment of varicose veins.~     AngioDynamics, Inc., the company that manufacturers the VenaCure device, is sponsoring this~     study to assess the safety and effectiveness of the VenaCure EndoVenous Laser Treatment~     (EVLT) 400 µm Fiber Kit for treatment of incompetent perforator veins (IPVs). The VenaCure~     EVLT 400 µm Fiber Kit has not been previously studied by AngioDynamics for the ablation of~     IPVs.~   "
103293|NCT02215356|"~     This randomised, multi-center, controlled trial is designed to assess the efficacy and safety~     of icotinib with concurrent radiotherapy versus chemotherapy with concurrent radiotherapy in~     non-small cell lung cancer~   "
103294|NCT02215343|"~     The main objective of this study is to investigate in detail how a high-(prebiotic)fibre diet~     and a high-PUFA diet affect the gut microbiota composition in a metabolic challenged~     population, and if the diet-induced modulation of the gut microbiota mediates changes in~     metabolic risk markers.~      Intake of both experimental diets over 4 weeks are expected to induce beneficial changes in~     the gut microbiota composition and to affect markers for insulin sensitivity, lipid~     metabolism and inflammation. The investigators hypothesize that the effect of both~     interventions on the metabolic risk markers will be partly mediated by the diet-induced~     changes in the gut microbiota composition.~   "
103295|NCT02215330|"~     Central serous chorioretinopathy (CSC) is supposedly the fourth most common non-surgical~     retinopathy after age-related macular degeneration, diabetic retinopathy and branch retinal~     vein occlusion. The disease was first described by Albrecht von Graefe in 1866 as a~     'recurrent central retinitis' and is nowadays commonly known as 'central serous~     chorioretinopathy', a term mainly coined by Donald Gass in the late 1960s.~      Although the disease has been known for decades, the underlying mechanism is not yet fully~     understood. Numerous studies have shown an involvement of the retinal pigment epithelium~     (RPE) and the choroid which lead to accumulation of subretinal fluid with subsequent~     detachment of the neurosensory retina.~      Among several assumed risk factors, high serum glucocorticoid levels seem to be related to~     the occurrence of CSC.~      CSC typically affects young, male patients unilaterally and causes decreased and distorted~     vision, often associated with metamorphopsia, micropsia, dyschromatopsia and reduced contrast~     sensitivity. CSC can occur in an acute or chronic form. However, there is no agreement in the~     literature concerning the duration of the two forms. Some authors define CSC as chronic if~     there is persistent subretinal fluid for at least 6 months 11, others speak of chronic CSC~     when symptoms last longer than 3 months. In contrast there are studies where CSC is defined~     acute within the first 4 months. Spontaneously absorption is possible in up to 50% and~     normally leads to the recurrence of a normal visual acuity. Chronic CSC can result in a wide~     spread RPE damage and in a constantly reduction of visual acuity.~      Structural changes in the retina and RPE have been found about 2 months after onset of the~     disease. Those changes can cause accumulation of photoreceptor outer segments, lead to~     consecutive atrophy of the photoreceptor cells and are associated with a loss of visual~     acuity.~      Different concepts of treatment exist, but none of these may be deemed to be the golden~     standard. In the past few years several studies where CSC was treated with photodynamic~     therapy (PDT) or half-fluence PDT showed good visual outcomes and morphologic reconstitution.~     However, PDT is a destructive method which causes structural damage and can trigger other~     severe complications like choroidal ischemia and iatrogenic CNV. Furthermore, CSC is a~     self-limiting disease in many cases and physicians often hesitate to perform a relatively~     destructive therapeutical approach to treat a potentially self-limiting disease.~      A newer, non-destructive therpeutical concept is the oral use of eplerenone a~     mineralocorticoid receptor antagonist. It is currently used in the treatment of hypertension~     and congestive heart failure. In the recent literature it was shown that eplerenone improved~     CSC and no serious adverse effects were observed in any case. However, no randomised~     controlled studies were performed comparing eplerenone with placebo to evaluate the clinical~     effect.~   "
103296|NCT02215317|"~     Elucidating the effects of obstructive sleep apnea (OSA) on cardiovascular outcomes is~     crucial in risk assessments and therapeutic recommendations for affected individuals. The~     Sleep and Stent Study is a multi-center observational study investigating the relationships~     between OSA and cardiovascular outcomes in patients treated with percutaneous coronary~     intervention (PCI).~   "
103297|NCT02215304|"~     Study to evaluate the safety and tolerance of three probiotic bacteria intake by healthy~     infants. Participants are divided at random and unknown to the researchers, in four groups,~     three of which receive one of three probiotic bacteria while the fourth group receives~     placebo product.~   "
103298|NCT02215291|"~     Prospective, multi-site registry with longitudinal follow up for patients undergoing EGD or~     endoscopy. The primary objective is to provide a collection of patient NvisionVLE™ procedural~     data for participating physicians, including, but not limited to, imaging data, clinical~     utility data, demographics, pathology, treatment, and surveillance.~   "
103311|NCT02215122|"~     This is a crossover study to assess the systemic pharmacokinetics of fluticasone propionate~     (FP) and salmeterol (SAL). Study medication will be administered as fixed dose combinations~     (250 µg FP and 50 µg SAL) from the Advair® Diskus®, Seretide™ Accuhaler™ and CRC749 inhalers.~   "
103312|NCT02215109|"~     The authors investigated the consecutive change of retinal vessel's diameter in affected eye~     and fellow eye of Branch Retinal Vein Occlusion.~   "
103357|NCT02214524|"~     This is a randomized, open label, parallel two arm, clinical study, which compare the Bair~     Hugger forced-air warming blanket and the conventional warming care practice in China on~     patients undergoing major surgery to determine the impact of maintaining normothermia on~     intraoperative blood loss, requirement for transfusion of packed red blood cells and the~     changes of coagulation function.~   "
103299|NCT02215278|"~     Recent iron absorption studies with biofortified beans indicated that the currently developed~     beans do not provide an extra amount of iron compared to normal iron beans. This effect was~     ascribed to the inhibitory nature of phytic acid (PA), which is present in high~     concentrations. A possible solution to alleviate problems associated with the high PA~     concentration in beans might be low phytic acid (lpa) bean seeds. These beans, which exhibit~     a good agronomic performance, were tested in a human absorption study in Switzerland and~     provided a higher amount of bioavailable iron compared to their parent beans with normal PA~     concentrations. However, the informative value of the study for the real life situation is~     limited due to the simple study design with a relatively large amount of isotopic label added~     extrinsically (≈30% of total iron). Furthermore, the study was conducted in iron sufficient~     women in a non-bean consuming population. Additional investigations are necessary to verify~     that iron bioavailability from lpa beans is high and that their performance is better~     compared to common biofortified beans in a real life situation. A multiple meal randomized~     crossover study in Rwandese women with low iron status will be done to measure iron~     absorption from three different beans (lpa bean line, biofortified high iron bean, normal~     iron bean as a control). During the study, the subjects will receive multiple meals to reduce~     the amount of extrinsic label, therefore more closely simulating hypothetical dietary iron~     intake from lpa beans. This will also allow to avoid an overestimation of the effect of~     inhibitors and to minimize the influence of intra subject day to day variation. The study~     will be divided into two parts. In part one, two of the three bean varieties will be fed as~     part of composite meals over several days (morning and lunch) and in part two, the remaining~     bean will be administered as part of composite meals over several days (morning and lunch).~     Iron absorption from the three varieties will be measured and compared with erythrocyte~     incorporation of stable isotopic labels 14 days after test meal administration.~   "
103300|NCT02215265|"~     The main objectives of the PATHOS study are:~      To assess whether swallowing function can be improved following transoral resection of~     HPV-positive OPSCC, by reducing the intensity of adjuvant treatment protocols. The aim is to~     personalise treatment, based on disease biology (HPV status and pathology findings), to~     optimise patient outcomes.~      To demonstrate feasibility of recruitment- if the phase II recruits successfully, PATHOS will~     continue to a Phase III study aiming to show non-inferiority of survival in the reduced~     intensity treatment arms.~   "
103301|NCT02215252|"~     The purpose of this study is to evaluate the efficacy and safety of PF-05089771 as a~     monotherapy and as an add-on to pregabalin for the treatment of painful diabetic peripheral~     neuropathy (DPN)~   "
103302|NCT02215239|"~     The purpose of this study is to investigate the effectiveness of intervention applying WHO~     Healthy Workplace Framework and Model to enhance the level of physical activity on employees.~     This research is an experimental intervention study recruiting two working types in four~     workplaces. Two working types are: (1) Working type A: Workers tend to be seated during work~     hours. Two telecommunications enterprises will respectively stand for the experiment group~     and the control group. (2) Working type B: Workers tend to be standing during work hours.~     Likewise, two different enterprises will respectively stand for the experiment group and the~     control group. Purposive sampling method will be used to select the experiment group. The~     intervention plan is to implement a cyclic or iterative process recommended by WHO.~   "
103303|NCT02215226|"~     Compare anticapsular antibody levels against Group B Streptococcus at delivery in mothers and~     their infants who develop disease versus those who do not. Use this comparison to establish~     antibody levels associated with reductions in risk of GBS disease in infants aged less than~     90 days.~   "
103304|NCT02215213|"~     The study is randomized blinded trial of Vitamin D supplementation to pregnant women; the~     study participants will receive Vitamin D in supplement form. Pregnant women will be~     individually randomized to three groups receiving a dose of 400, 2000 and 4000 IU/ day till~     the time of delivery.A blood sample will also be collected from the participant at the time~     of recruitment /before the starting of the supplementation for the assessment of Calcium,~     Phosphorus, Alkaline Phosphatase and Vitamin D levels. The second blood sample for vitamin D~     level to assess vitamin D status will be done after completion of the supplementation phase~     at the time of delivery (till 48 hours of delivery). The samples will be sent to Aga Khan~     University laboratory~   "
103305|NCT02215200|"~     This is a three-arm, 1:1:1 randomized, placebo controlled, double- blinded trial in which at~     least 28 subjects will receive active Anti-Thymocyte Globulin and Granulocyte~     colony-stimulating factor (ATG-GCSF), at least 28 subjects will receive ATG alone and at~     least 28 subjects will receive placebo alone within 100 days from diagnosis of Type 1~     Diabetes (T1D).~      The primary objective of the study will be to determine the safety and ability of low dose~     ATG plus GCSF and low dose ATG alone to retain/enhance C-peptide production in new onset T1D~     patients demonstrating residual beta cell function.~   "
103306|NCT02215187|"~     The primary purpose of this research is to evaluate the impact of a telehealth-based,~     cognitive behavioral therapy (CBT) intervention (problem-solving training: PST) for adult~     informal military family/friend caregivers of OIF/OEF service members with a~     deployment-related TBI.~   "
103307|NCT02215174|"~     Statins are the first-line and most commonly prescribed drugs for the prevention of~     cardiovascular diseases and stroke in the world. Our preliminary studies suggest that~     Caucasians might have a higher risk of developing potentially life-threatening drug-drug~     interactions than Asians when taking statins. Drug-drug interactions occur in the body when~     two or more drugs interact in a way that alters their effectiveness and/or toxicity. These~     interactions are becoming an increasingly severe problem with statin usage since patients at~     higher risk for cardiovascular diseases also take statins combined with many other drugs,~     such as antihypertensive and diabetic drugs. Our study is aimed at understanding the~     molecular factors and providing a sound basis for the interethnic dosage and response~     differences for statins.~      Drug-transporting proteins in intestine and liver tissues are responsible for taking up~     statins into the blood. It is hypothesized that there are interethnic function differences of~     these proteins and that they account for differences in statin blood levels between~     Caucasians and Asians and the frequency and/or severity of their respective drug-drug~     interactions. A clinical study will be conducted with Caucasian and Asian subjects undergoing~     gastric bypass surgery so excess intestine and liver tissue can be acquired as part of the~     standard procedure. Protein levels will be quantified in the tissues and correlate them with~     different statin blood levels.~   "
103308|NCT02215161|"~     This phase II trial studies selinexor in treating patients with prostate cancer that has~     spread to other parts of the body (metastatic), keeps growing even when the amount of~     testosterone in the body is reduced to very low levels (castration-resistant), and did not~     respond to treatment (refractory) with abiraterone acetate and/or enzalutamide. Selinexor may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
103309|NCT02215148|"~     To assess the pharmacokinetic profile of tolvaptan in critically ill acute brain injury~     patients and to secondarily evaluate the clinical response and safety of tolvaptan in acute~     brain injured patients~   "
103313|NCT02215096|"~     This Phase I, open-label, dose-finding, multicenter study is designed to determine the~     recommended Phase II dose (RP2D) for the combination of an orally administered~     Phosphatidylinositol-4,5-bisphosphate 3-kinase beta (PI3K-beta) inhibitor (GSK2636771) with~     enzalutamide. Subjects with phosphatase and tensin homolog (PTEN)-deficient metastatic~     castration-resistant prostate cancer (mCRPC) who are receiving a stable dose of enzalutamide~     with a recently demonstrated progression (either by RECIST [Response Evaluation Criteria In~     Solid Tumors] version 1.1, prostate-specific antigen [PSA] progression, and/or progression in~     bone) per the Prostate Cancer Working Group 2 (PCWG2) criteria will be enrolled. Eligible~     subjects will be enrolled in the Dose-Escalation Phase to determine the maximum tolerated~     dose (MTD) of the combination therapy using a modified 3+3 dose escalation procedure. The~     safety, pharmacokinetics (PK) and clinical efficacy will also be assessed to guide the~     selection of the RP2D. The starting dose will be GSK2636771 300 mg once daily in combination~     with the recommended dose (160 milligram [mg] once daily) of oral enzalutamide. Once the RP2D~     has been established, additional subjects will be enrolled in the Dose Expansion Phase to~     further evaluate the safety, PK and preliminary clinical activity. Safety assessments will be~     performed throughout the study including physical examinations, vital signs, clinical~     laboratory tests, 12 lead electrocardiograms and monitoring of adverse events. Blood samples~     will be collected for pharmacokinetic analysis. Subjects will continue treatment until an~     unacceptable toxicity, disease progression, withdrawal of consent or death occurs. A~     post-treatment follow-up visit will be performed within 30 days of the last dose of study~     treatment. Xtandi is a registered trademark of Astellas Pharma Inc~   "
103314|NCT02215083|"~     The purpose of the study is to determine whether daily, high-dose administration of~     l-glutamine can reduce numbness and tingling caused by a taxane chemotherapy in patients with~     breast cancer.~   "
103315|NCT02215070|"~     The purpose of this study is to evaluate if the drug, Pasireotide, is safe and effective in~     reducing the gastrointestinal side effects of the drugs received to prepare for allogeneic~     stem cell transplant. The study will also evaluate if Pasireotide is effective in reducing~     acute and chronic Graft-versus-Host-Disease (GvHD) after transplant.~   "
103316|NCT02215057|"~     General anesthesia may be non preferable in many patients undergoing Phakic IOL surgery, as~     most of the surgeries take 5-10 minutes at maximum.Traditionally, retrobulbar injections were~     performed deep into the orbit, but it is now accepted that peribulbar injections using~     shorter needles are safer. In the last few years, continuing concern over the rare but~     serious complications of sharp needle blocks has led to increasing interest in the use of~     sub-Tenon`s blocks utilizing a blunt cannula 1-5.~      Even with the use of blunt canulae sub-Tenon`s block, serious problems can still occur,~     especially in myopic patients with large axial length. In phakic IOL surgery,topical~     anesthesia has been used successfully for years. Topical anesthesia has several advantages~     over regional infiltrative techniques, the foremost of which is the abolition of any risk of~     inadvertent injury of the globe or orbital contents 6,7,8. It has a high rate of patient~     satisfaction, but still there are some patients that experience intraoperative discomfort.~      In this study we compared topical anesthesia alone with topical anesthesia plus intracameral~     lidocaine 1% in patients undergoing posterior chamber phakic intra ocular lens;Vision~     implantable collamer lens ( ICL/toric ICL) surgery.Intracameral anesthesia is a common~     adjunct to topical anesthesia in anterior segment surgery9. It probably provides sensory~     blockage of the iris and ciliary body and thereby relieves discomfort experienced during IOL~     placement. Intracameral lidocaine alone dilates the pupil well 10 and this is believed to be~     because of the direct action of lidocaine on the iris, which in turn causes muscle~     relaxation.~   "
103317|NCT02215044|"~     Determination of the maximum tolerated dose (MTD), safety, and tolerability when BI 2536 was~     given on Day 1 and Day 15 in combination with gemcitabine given on Day 1, Day 8 and Day 15~     every 28 days in patients with locally advanced or metastatic pancreatic adenocarcinoma and~     characterisation the antitumor activity, pharmacokinetic (PK) profile, and CA 19-9 tumor~     marker response in response to the combination of BI 2536 with gemcitabine in patients with~     locally advanced or metastatic pancreatic adenocarcinoma.~   "
103318|NCT02215031|"~     Study to investigate safety, tolerability, and pharmacokinetics of BI 44370 BS solution for~     intravenous (i.v.) infusion~   "
103319|NCT02215018|"~     To evaluate the safety, tolerability and pharmacokinetics of single rising oral doses of BI~     44370 TA in healthy male volunteers, to compare a drinking solution vs. a tablet formulation~     and to assess intra-individual pharmacokinetic (PK) variability by re-dosing two further~     doses.~   "
103320|NCT02215005|"~     The main objective was to investigate the effect of concurrent dosing of 10 mg ramipril and~     80 mg telmisartan on the multiple-dose pharmacokinetics of telmisartan and ramipril.~     Therefore the relative bioavailability of telmisartan and ramipril given in combination was~     determined in comparison with either telmisartan or ramipril given alone.~   "
103321|NCT02214992|"~     Study to demonstrate the bioequivalence of 80 mg telmisartan/10 mg ramipril fixed dose~     combination versus its monocomponents given concurrently~   "
103322|NCT02214979|"~     Study to demonstrate the bioequivalence (BE) of 40 mg telmisartan/ 2.5 mg ramipril fixed-dose~     combination (FDC) versus its monocomponents given concomitantly~   "
103323|NCT02214966|"~     The objective was to investigate the relative bioavailability of the fixed dose combination~     (FDC) tablet (80 mg telmisartan / 10 mg ramipril) after food intake in comparison to the~     bioavailability of the FDC tablet while fasting.~   "
103324|NCT02214953|"~     To compare the oral bioavailability and rate of absorption of four prototype extended-release~     (ER) formulations with BI 11634 (single doses) to immediate-release (IR) tablets in healthy~     male volunteers.~   "
103325|NCT02214940|"~     First evaluation of safety, tolerability, pharmacokinetics, and the pharmacodynamic effect of~     BI 11634 on coagulation parameters after multiple-dose administration (no primary endpoint in~     a statistical sense defined)~   "
103326|NCT02214927|"~     -  Characterisation of the relative bioavailability of the IR-tablet vs. oral drinking~          solution (no primary endpoint in a statistical sense)~        -  Safety and tolerability of the IR-tablet formulation and solution~        -  PK profile of the single ascending doses of the IR-tablet formulation (including~          analysis of dose proportionality)~   "
103327|NCT02214914|"~     First evaluation of safety, tolerability, pharmacokinetics and the pharmacodynamic effect of~     BI 11634 on coagulation parameters~   "
103328|NCT02214901|"~     Study to investigate safety, tolerability, and pharmacokinetics of BIBW 2948 BS~   "
103329|NCT02214888|"~     Study to determine the efficacy (including American College of Rheumatology (ACR) 20 response~     rate), safety, and pharmacokinetics of BIRB 796 BS as monotherapy in patients with moderate~     to severe rheumatoid arthritis who have failed at least one disease modifying antirheumatic~     drug (DMARD)~   "
103330|NCT02214875|"~     This study aims to address the research question: Will continuous quality improvement, using~     a Break Through Series approach, increase uptake of PMTCT services and retention-in-care of~     HIV-infected pregnant women and mothers at six and 12 months postpartum?~      Continuous Quality Improvement (CQI) is a health systems intervention to assist programs to~     systematically improve services and health outcomes. The Break Through Series (BTS) is a~     specific CQI approach is a short-term (6- to 15-month) learning system that brings together~     teams from several hospitals or clinics (collaboratives) to seek improvement in a focused~     topic area through a common process of data sharing and review Primary Objective To assess~     whether retention-in-care of HIV-infected women at six (6) months postpartum is higher at~     health facilities implementing CQI-BTS approaches than at health facilities not implementing~     CQI-BTS approaches.~      Secondary Objectives~      To assess whether implementation of CQI-BTS initiatives at health facilities increases:~        1. Uptake of PMTCT services by HIV-infected pregnant women;~        2. Retention-in-care of HIV-infected women at twelve (12) months postpartum;~        3. Retention-in-care of HIV-exposed babies at six (6) and twelve (12) months of age;~        4. Uptake of a pre-defined, minimum set of integrated RH/PMTCT services by HIV-infected~          women in health facilities.~   "
103331|NCT02214862|"~     The PET tracer [F18]-FDDNP has a specific affinity for lesions containing tau protein.~      The study consists of two phases:~        -  In the first (cross-sectional) phase it will be assessed the uptake of [18F]-FDDNP in 10~          cases with progressive supranuclear palsy (PSP, a tauopathy) en 10 with multi-system~          atrophy (MSA, a non-tauopathy), along with 20 individuals with Unclassifiable~          Parkinsonism, as previously defined in a European cohort study.~        -  In the second (longitudinal) phase it will be prospectively followed the 20~          unclassifiable patients (at 6, 12 and 18 months) by means of validated scales and~          accepted diagnostic criteria in order to try to correlate their eventual clinical~          diagnosis with baseline PET findings. On this basis, we endeavour to estimate the~          ability of this technique to detect in vivo underlying tau pathology in subjects~          initially unclassifiable on clinical grounds.~      We hypothesized that:~        1. Patients with clinically definite PSP will present an increased uptake in basal ganglia,~          brainstem and cerebellum.~        2. Patients with clinically defined MSA will not present specific uptake.~        3. Part of unclassifiable patients with parkinsonism will present a pattern of uptake~          similar to patients with clinically defined PSP and this part along the clinical~          follow-up will be meet clinical criteria for diagnose of PSP~   "
103332|NCT02214849|"~     The purpose of this study is to find out if a two-way texting platform to be used as an~     adjunct tool for breastfeeding peer counselors can improve breastfeeding behaviors among~     women enrolled in the WIC program in Connecticut. The hypothesis of the study is that~     providing additional information and support through text messaging starting in pregnancy and~     continuing after the birth of the child will increase exclusive breastfeeding rates during~     the first six months of life.~   "
103333|NCT02214836|"~     The purpose of this study is to determine whether new software processing of ultrasound~     images can improve detection and size determination of kidney stones.~   "
103334|NCT02214823|"~     Project Summary: Patients who have a length of stay four or more days in ICU and requiring~     mechanical ventilation assistance to breathe for more than 48 hours will be invited to~     participate. Participants will be randomised to either receive Functional Electrical~     Stimulation (eStimCycle) assisted cycling or standard care. As cycling in bed has previously~     been shown to improve physical function, patients who receive cycling as a treatment will~     have one leg that cycles and the other leg that cycles with assistance of electrical~     stimulation as we want to establish the effectiveness of the addition of electrical~     stimulation of muscle. Muscle bulk, strength and physical function outcome measures will be~     measured at baseline, weekly in ICU, ICU discharge and hospital discharge. Cognitive function~     will also be measured at hospital discharge, 6- and 12-month follow-up. A small group of~     patients in this study will be invited to provide samples of blood, urine and muscle at ICU~     admission and discharge to try and determine what happens to muscle in patients who are~     critically ill.~      Significance of the Project: This is an important study because the development of~     ICU-acquired weakness (ICU-AW) can result in long term limitations in physical function.~     Early treatment to maintain strong muscles during an intensive care stay may help speed up~     recovery and enhance participation in other rehabilitation treatments and improve functional~     activities and cognition. These are important objectives for both patients and their~     families. In addition understanding why the muscles become so weak so quickly in patients in~     ICU will help to develop treatments that may help to maintain muscle strength.~      Study Hypotheses:~      Hypothesis 1: eStimCycle versus usual care rehabilitation will improve muscle strength at~     hospital discharge.~      Hypothesis 2: eStimCycle versus usual care rehabilitation will improve cognitive function at~     6 month follow up.~      Hypothesis 3: Patients receiving eStimCycle will have improved activity of anabolic~     signalling pathways and less atrophy of skeletal muscle fibre size compared with usual care~     rehabilitation.~   "
103335|NCT02214810|"~     Postsurgical pain may effectively be treated with a multimodal approach that incorporates the~     use of local anesthetics. Bupivacaine is a local anesthetic that has been proven to be~     effective at reducing postsurgical pain. Furthermore, this local anesthetic has been shown to~     reduce opioid use, improve functional outcomes, allow for early mobilization, and decrease~     hospital length of stay. However, local anesthetics, via wound infiltration, are often~     short-acting and do not meet the duration of postsurgical pain due to their solubility and~     protein-binding properties. ExparelTM is an FDA-approved liposomal formulation of bupivacaine~     that allows for 72 hours of postsurgical analgesia with a single injection. This formulation~     has been shown to have little to no adverse effects; although some studies have reported~     adverse effects with the use of ExaprelTM, most frequently being nausea, vomiting, and~     dizziness. The occurrences of these adverse events were still less than the placebo cohort.~   "
103336|NCT02214797|"~     The aim of this study is to assess visual performance of prototype soft contact lens designs~     compared to commercially available contact lenses over one-week of lens wear.~   "
103337|NCT02214784|"~     Stress Urinary Incontinence (SUI) is described as an uncontrolled loss of urine which happens~     when physical activities such as running, jumping and lifting etc are carried out or when~     increased pressure to the bladder in everyday life is applied by simply sneezing or coughing.~      There are various treatment options available - surgical operations, pelvic floor~     exercises/muscle training and electrical stimulation. This study aims to prove that using the~     Neurotech Vital device for 12 weeks can stimulate the pelvic floor muscles to strengthen and~     tone them and in doing so improving stress urinary incontinence. We are comparing the~     Neurotech Vital device with an altered Neurotech Vital device that does not give the same~     stimulation treatment. There is a 50% chance of you receiving the altered device, if you do,~     you will be offered the non-altered Neurotech vital device after your first 12 week treatment~     programme. Both devices are identical in looks, but give different stimulations through the~     skin contact electrodes.~   "
103338|NCT02214771|"~     The study aims to describe the characteristics and the methods of management and follow-up of~     patients treated with fidaxomicin for Clostridium difficile infection (CDI).~   "
103341|NCT02214732|"~     Anxiety, stress and depression are common during pregnancy and in the postpartum period. The~     lack of empirically supported, non-pharmaceutical interventions for psychological distress in~     pregnancy is a significant gap in the literature, especially given many pregnant women's~     preference for non-pharmaceutical treatments. This study will evaluate the efficacy of~     Mindfulness Based Cognitive Therapy (MBCT) program in reducing measures of psychological~     distress (e.g., symptoms of stress, depression and anxiety) in a group of pregnant women~     endorsing high levels of distress.~   "
103342|NCT02214719|"~     A closed loop system for diabetes care utilizing an insulin pump, continuous glucose sensing~     and appropriate mathematical modelling to guide insulin dosing is a goal for those with Type~     1 diabetes. Yet the cost of the associated hardware will be prohibitive for many people with~     diabetes or their health care payers. Carbohydrate counting, insulin dose correction systems,~     basal bolus regimens with or without an insulin pump all facilitate glucose control but~     frequent adjustment to a diabetes regimen is a necessary cornerstone to successful diabetes~     management; if all that is used is the regimen suggested by the health care provider at a~     visit and this regimen is left unchanged until the next visit or contact then success will be~     limited. A readily available user friendly program suitable for a smart phone or tablet would~     have widespread applicability and benefit. The investigators hypothesize that such an app~     linked into a web site that facilitated review of glucose records will be acceptable to~     people with diabetes and improve glucose control. Our long term goal is to create an app that~     can advise on diabetes management.~   "
103343|NCT02214706|"~     The purpose of this study is to improve the therapeutic outcome of laser therapy for port~     wine stains by using a combination treatment of the pulsed dye laser (PDL), erbium yag laser~     and topical sirolimus.~   "
103344|NCT02214693|"~     This is a clinical study to investigate the pharmacokinetics/pharmacodynamics and~     tolerability of DA-1229(Evogliptin) tabletin renal impaired patients.~   "
103345|NCT02214680|"~     In this study we will explore the combined effect of Brimonidine and Timolol 0.5% (Combigan)~     eye drops on pupil dilation. It is a well studied phenoma that Brimonidine and a miotic~     effect on the pupil, however the combined effect of alpha agonist and beta blocker has not~     been studied.~   "
103346|NCT02214667|"~     Treatment adaptation and implementation study for adult jail inmates with co-occurring~     substance use disorders.~   "
103347|NCT02214654|"~     The purpose of this study is to compare clopidogrel with ticagrelor which one has stronger~     anti-inflammation effect to protect against type 2 diabetes-induced vascular damage.~   "
103348|NCT02214641|"~     This three-year award will pilot-test an innovative intervention, Resilient, Empowered,~     Active Living with Diabetes (REAL), targeting underserved minority young adults with~     poorly-controlled diabetes. The individually tailored, community-based intervention merges~     findings of an in-depth needs assessment, principles of an evidence-based occupational~     therapy intervention (Lifestyle Redesign®) and evidence-based diabetes self-management~     strategies. A proof-of-concept study demonstrated that REAL is feasible to implement,~     acceptable to young adults with type 1 diabetes and type 2 diabetes, and has potential to~     produce positive changes in diabetes self-care and glycemic control. The study will randomize~     80 young adults with diabetes to receive either the six-month REAL intervention or an~     attention control condition. Blinded data collectors will assess glycemic control, diabetes~     self-care behaviors and quality of life outcomes, as well as potential intervention~     mediators, before and after the six-month intervention. It is anticipated that findings from~     this pilot study will be used to inform a large-scale randomized controlled trial of the REAL~     intervention.~      The study's specific aims and hypotheses are as follows:~      Aim 1. Determine the intervention's efficacy for the primary outcomes: glycemic control and~     diabetes self-care.~      Hypothesis: At 6 months (immediately following the intervention), intervention group~     participants will demonstrate improvements in A1C and diabetes self-care as compared to~     control group participants.~      Aim 2. Conduct exploratory analyses of the intervention's impact on secondary outcomes and~     potential mediating mechanisms (to inform power estimates for a large-scale RCT).~      Hypothesis 1: At 6 months, intervention group participants will demonstrate improvements in~     secondary outcomes: diabetes-related stress and quality of life, depression, and life~     satisfaction as compared to control group participants.~      Hypothesis 2: At 6 months, intervention group participants will demonstrate improvements in~     potential mediators of the intervention: habit strength, problem solving, activity~     participation, self-efficacy and diabetes knowledge as compared to baseline.~      Aim 3. Conduct a process evaluation utilizing mixed methods to evaluate and refine~     intervention delivery (e.g. treatment fidelity, patient satisfaction) and study procedures~     (e.g. recruitment, retention, testing protocol).~   "
103349|NCT02214628|"~     The objective is to evaluate the safety of intravitreal Fovista® (anti-PDGF BB) administered~     in combination with anti-VEGF therapy~   "
103350|NCT02214615|"~     This research study is designed to investigate brain response using fMRI scan, and behavioral~     responses, to treatment with the drug carbamazepine (CBZ) in patients with the painful sodium~     channelopathy inherited Erythromelalgia (IEM). This study is designed to identify the central~     nervous system (CNS) regions that are activated during ongoing or evoked pain attacks, and~     the altered CNS response to CBZ treatment. This will advance our understanding of how IEM~     affects the brain. We also hope to validate a pharmacogenic approach to the study of IEM by~     use of an FDA approved drug. We hope, but cannot be sure, that subjects will directly benefit~     from this study.~   "
103351|NCT02214602|"~     The aim of the study is to test the value of immediate post-operative intravesical~     instillation of epirubicin in patients with intermediate and high risk non muscle invasive~     bladder cancer (NMIBC).~   "
103352|NCT02214589|"~     A. Specific Aims Premature infants admitted to the neonatal intensive care unit (NICU)~     require up to several hundred procedures during their hospitalization. Many of these are~     tissue-damaging procedures (TDPs) known to cause pain [1]. Through funding from NINR, the~     investigators found that TDPs not only caused pain but also increased markers of ATP~     degradation and oxidative stress[2[. The TDP was tape removal, a commonly performed procedure~     in the NICU2.~      Based on this finding, the investigators sought to determine if interventions that relieve~     pain also reduce biochemical markers of ATP degradation and oxidative stress. The~     investigators first examined the effect of oral sucrose, a commonly used intervention, when~     given before a heel lance. The investigators chose heel lance because it is the most~     predominant painful procedure in the NICU, as shown in 29 different clinical trials[3]. The~     investigators hypothesized that since oral sucrose is documented to significantly reduce pain~     scores, then administration of this analgesic will also decrease markers of ATP degradation~     and oxidative stress. However,the investigators observed the opposite effect. Although a~     single dose of oral sucrose reduced behavioral markers of pain, it significantly increased~     biochemical markers of ATP degradation (hypoxanthine, uric acid) and oxidative stress~     (allantoin) over time[4]. More importantly, the effect of oral sucrose on breakdown markers~     of ATP were enhanced and were significantly higher in neonates that were intubated or were~     receiving more than 30% FiO25. These findings lead to the question: If oral sucrose does not~     effectively reduce the biochemical effects of procedural pain, what intervention or groups of~     intervention will decrease both behavioral markers of procedural pain and reduce ATP~     utilization and oxidative stress in premature neonates? For this RO1 renewal, the~     investigators propose to test the individual and additive effects of two commonly used~     interventions for procedural pain. These interventions are (a) administration of 30% oral~     glucose and non-nutritive sucking (NNS) (b) facilitated tucking and NNS c) administration of~     30% oral glucose, facilitated tucking and NNS. Administration of 30% oral glucose was~     documented to decreased procedural pain scores[6-9] without the potential adverse effects of~     fructose, a key ingredient of sucrose[10-11]. Facilitated tucking is the gentle positioning~     of preterm infants with arms and legs in a flexed, midline position close to the body, while~     either in a side-lying or prone position[12]. Because tachycardia often accompanies pain, a~     documented benefit of facilitated tucking is stabilization of heart rate and reduction of~     motor activity (flailing)[12-13]. Non-nutritive sucking refers to the provision of a~     weight-appropriate pacifier[14]. The painful procedure will be a clinically required heel~     lance, which refers to the puncture of a newborn's heel for blood glucose using a specially~     designed lancet. Our general hypothesis is that commonly used clinical interventions known to~     reduce procedural pain alter biochemical markers of ATP degradation, oxidative stress and~     cell injury.~      Specific Aim 1 will determine whether (a) 30% oral glucose and NNS or (b) facilitated tucking~     and NNS or (c) 30% oral glucose with facilitated tucking and NNS will decrease procedural~     pain.~      • Pain will be quantified using a validated pain scoring tool, the Premature Infant Pain~     Profile (PIPP). Individual and additive effect of interventions will be determined.~      Specific Aim 2 will determine whether (a) 30% oral glucose and NNS or (b) facilitated tucking~     and NNS or (c) 30% oral glucose with facilitated tucking and NNS will decrease biochemical~     markers of ATP degradation, oxidative stress and oxidative cell injury.~        -  Products of ATP breakdown in plasma—hypoxanthine (Hx), xanthine (Xa), and uric acid~          (UA)—will be measured using high performance liquid chromatography.~        -  Oxidative stress will be quantified by measuring plasma levels of allantoin using mass~          spectrometry.~        -  Cell injury will be quantified by measuring plasma levels of F2 isoprostane using~          liquid-chromatography/mass spectrometry.~   "
103353|NCT02214576|"~     Tracheal intubation in the ICU is associated with significant complications and morbidity.~     Desaturation is among the most frequent and hazardous complication, occurring in almost one~     out of four intubations, that may in some instances lead to cardiac arrest; despite~     appropriate preoxygenation. Non-invasive ventilation may help improve preoxygenation but does~     not allow for apneic oxygenation and may not be performed in patients with neurological~     impairment. High flow nasal canula oxygen is increasingly used in the ICU in patients with~     acute hypoxemic respiratory failure and may be used to improve preoxygenation. It is~     currently used in our ICU for that purpose. Because high flow nasal canula oxygen is our~     first line oxyten therapy for patients with acute respirtory distress syndrome, we sought to~     determine its use as a means to ensure preoxygenation in those ARDS patients that require~     intubation.~   "
103354|NCT02214563|"~     The purpose of this study is to determine whether cholecalciferol supplementation decrease~     the blood concentrations of hepcidin-25 in hemodialysis patients.~   "
103355|NCT02214550|"~     The purpose of this study is to determine if some women with dysmenorrhea (painful periods)~     are at higher future risk of developing chronic pelvic pain (CPP) and if oral contraceptives~     (OC) can be used to reverse this chronic pain risk.~      Investigators will examine whether dysmenorrhea produces CPP via repetitive cross organ~     sensitization (COS) episodes. The use of cyclical OCs to eliminate dysmenorrhea is expected~     to reduce COS and decrease the risk of developing CPP.~   "
109122|NCT02139111|"~     The purpose of this randomized, placebo-controlled, double-blind, parallel group study is to~     evaluate the clinical efficacy and safety of PRC-063 in adolescents with ADHD.~   "
103358|NCT02214511|"~     Major depression disorder (MDD) is a frequent and disabling mental disorder with great risk~     of recurrence and chronicity. Interpersonal factors are among the strongest predictors of the~     course and duration of an episode of depression. More specifically, social rejection is one~     of the most environmental risk factors of MDD. Targeted rejection predicts hastened onset of~     major depression. On the other hand, healthy subject show prosocial behavior after social~     rejection to reconnect to new source of social interaction. In addition to the potential~     impact of social exclusion on MDD onset, depressed patients may be more prone to be rejected~     as they encounter interpersonal difficulties and may less be able to reconnect to the social~     group after rejection.~      Recent neuroimaging data show that brain processing of social exclusion activate brain~     regions that are central to the pathophysiology of MDD. Some of these regions are also known~     to be activated during physical pain and may contribute to the aversive dimension of the~     experienced rejection. Pro-inflammatory cytokines are involved in MDD physiopathology and can~     induce social withdrawal behavior. Inflammation can modulate social interactions in mammals.~     Moreover, after a social stress such as social rejection, blood cytokines increase. At a~     cognitive level, self-esteem can modulate the sensitivity to social rejection.~      The major objective of the trial is to study sensitivity to social signals in MDD patient~     compared to healthy subject.~      The investigators hypothesize in MDD patient : (1) decrease of rapid facial reactions (RFR)~     to dynamic emotional faces expressing joy, (2) increase of RFR to dynamic emotional faces~     expressing sadness, (3) decrease of prosocial reaction after experimental social rejection.~      Secondary objective is to identify psychological and biological mediators We hypothetize in~     MDD patient: (1)mediating effect of systemic inflammatory cytokines, an (2) mediating effect~     of state self esteem 30 MDD patients and 60 healthy subject will be included. They will~     encounter psychiatric and psychometric evaluation. Their facial EMG will be recorded to~     assess RFR to dynamic emotional faces created by photo morphing from KDEF emotional faces~     database, coupled to occulometric recording. Subjects will perform cyberball game as an~     experimental inclusion or exclusion task and the trustgame task as an implicit evaluation of~     their prosocial behavior. Questionnaires will assess explicit measurement of social rejection~     pain and desire of affiliation. Inflammatory markers will be measured in a blood sample~     before the cyberball task for every subjects and 6 hours later for 20 healthy volunteers.~     Dosage of IL-6, IL-10, TNFa, IP-10, MCP-1, MIP-1b, Rantes, sIL-6Ra, IL1ra, VEGF, Leptin,~     PECAM1, sTie2, sVEGFR1, sVEGFR2 will be performed by luminex technique and usCRP, srIL2 ans~     sCD14 by ELISA technique.~   "
103359|NCT02214498|"~     Rationale:~      The nocturnal blood pressure mean is an independent and stronger predictor of cardiovascular~     disease (CVD) risk than either daytime office, awake or 24hour mean blood pressure. In~     general, when nocturnal blood pressure does not decline CVD risk is higher, usually referred~     to as dippers versus non-dippers. Evening administration of treatment might lower~     nocturnal blood pressure more effectively than morning administration, which is most commonly~     advised.~      The main hypothesis of this study is that evening administration of antihypertensive~     medication might resume the dipping pattern in non-dippers and as a consequence might reduce~     CVD risk more than morning administration.~      Primary objective (in short):~      -to prove that evening administration of enalapril/hydrochlorothiazide in non-dippers can~     resume a dipping blood pressure pattern in non-dippers~      Study design: A double-blind placebo-controlled cross-over study Each person will use for one~     period of six weeks enalapril/hydrochlorothiazide in the morning and placebo in the evening,~     and one period of six weeks the other way around~   "
103360|NCT02214485|"~     Objective: To determine the differential effectiveness of integrated care (IC) and lower~     extremity strength training (LEST) among community-dwelling frail older adults in Taiwan.~      Method: The investigators randomize participants at Bei-Hu site from the Intervention study~     of Geriatric Frailty, Osteoporosis, and Depression in a Community Based Randomized Trial~     into 12 weeks of either IC or LEST. Outcome assessments are performed at baseline, 12 weeks~     and 6 months after initiation of the interventions.~      Interventions:~        1. IC: Participants visit the study site with health education, social activities, warm up,~          stretch, and low intensity resistance exercise for about 1 hour per week. If any medical~          problems or functional decline suspected during the visit, the case manager refers~          participants to their primary care physicians for further managements.~        2. LEST: Participants receive 2 sessions of 30-minute lower extremity strength straining~          using isotonic strength training machines each week. The intensity is set at 60-80% of 1~          repetition maximum (RM). Evaluation of the exercise protocol are repeated every 2 weeks~          for individualized adjustments~   "
103361|NCT02214472|"~     Rumination syndrome is characterized by effortless recurrent regurgitation of recently~     ingested food into the mouth, with consequent expulsion or re-chewing and swallowing. In a~     previous study the investigators showed that rumination is produced by an unperceived,~     somatic response to food ingestion.~      After having identified the key mechanisms of rumination, the investigators developed an~     original EMG guided biofeedback technique with specific targets for correction, based on~     EMG-guided control of abdomino-thoracic muscular activity, and in a pilot study the~     investigators showed the potential effectivity of this treatment. The current aim is to~     validate this previous uncontrolled observation by a formal placebo-controlled, randomized~     trial.~   "
103362|NCT02214459|"~     The enormous burden of hypertension (HTN) creates a need for effective, scalable, low risk~     interventions. The DASH program of diet and exercise based lifestyle change is the most~     well-established, evidence-based behavioral intervention to control HTN. Its recommendations~     are central to HTN control national guidelines and consumer health products aimed at~     behavioral management of HTN. However, translating these recommendations into~     population-wide, inexpensive, sustainable programs have to date proven largely unrealized.~     The objective of the proposed study is to determine the efficacy of a HTN intervention~     behavior change platform, 'DASH Mobile', in which patients with HTN receive counseling about~     the DASH diet, physical activity and HTN related behaviors from health coaches trained in~     evidenced-based behavioral counseling methods. DASH mobile has two primary components: 1) a~     smartphone app that captures patients' behavioral data using intuitive self-tracking for DASH~     diet intake and Bluetooth wireless sensors for blood pressure, weight and physical activity~     and 2) a web-based coaching portal through which health coaches view and respond to patients'~     behavioral data and assist them in setting goals for changing behaviors consistent with their~     HTN behavior change plan. We aim to conduct a pilot trial of 30 HTN patients to determine~     improvement from baseline to 3-month follow-up in physiological (blood pressure, weight);~     behavioral (diet & physical activity); and psychological (e.g., quality of life) measures~     over a 3-month intervention. Completing this research will result in preliminary feasibility~     and efficacy data for a larger randomized efficacy trial.~   "
103363|NCT02214446|"~     The purpose in this study was to investigate the current status, changes, correlation, and~     predictive factors of the truth telling, hope, care burden, and quality of life during~     treatment in primary caregivers of newly diagnosed children with cancer.~   "
103384|NCT02214160|"~     The primary objective of this study is to evaluate the long-term safety and efficacy of UX007~     in LC-FAOD subjects. The secondary objectives of this study are to evaluate the effect of~     UX007 on energy metabolism in LC-FAOD and evaluate the impact of UX007 on clinical events~     associated with LC-FAOD.~   "
103385|NCT02214147|"~     The purpose of this study is to evaluate the effect of moderate or severe hepatic impairment~     on the single-dose pharmacokinetics of alisertib in adult participants with cancer.~   "
103364|NCT02214433|"~     Debio 1450-103 is a trial to study the pharmacokinetics (PK) of an experimental drug called~     Debio 1450 in healthy adult volunteers. Originally, Part A was registered separately (in~     NCT02214355). The registrations have been revised so all parts of this single trial (Parts~     A-C) are now included in this single registration (NCT02214433).~      The primary purpose of each part is provided below:~        -  10 volunteers participate in PART A to assess the PK of a single oral dose of Debio 1450~          (tablet formulation) under varying gastric conditions~        -  40 volunteers participate in PART B to assess the safety, tolerability and PK of~          multiple ascending doses of Debio 1450, administered sequentially IV and orally, once or~          twice daily.~        -  An additional 10 volunteers participate in PART C which is designed to assess the~          absolute bioavailability of various formulations of Debio 1450 under varying gastric~          conditions~      The dose administered during Part A is based on the safety, tolerability and PK data from~     study Debio 1450-102 [NCT02162199], a single ascending dose (SAD) study, in which single oral~     doses up to 800 mg/day are being investigated. Doses are adjusted during Parts B and C based~     on the available safety and PK data from preceding cohorts.~   "
103365|NCT02214420|"~     Prior trials have shown that many G1 CHC patients are ineligible or intolerant to PEG-based~     regimens due to prior severe side effects, worsening of cytopenias, exacerbation of~     underlying psychiatric disorders, or autoimmune disorders. These patients will not be~     candidates for treatment with the approvals of SMV and SOF in early 2014 due to the~     combination with PEG-regimens. Results of the COSMOS study suggest that these patients are~     likely to have excellent responses to SMV+SOF with or without RBV with 12 weeks of therapy,~     and that 24 weeks are unnecessary. This trial is designed to rapidly enroll and be completed~     in order to confirm this hypothesis.~   "
103366|NCT02214407|"~     This is a phase III, two-arm, randomized, stratified, multicenter, open-label study with~     individual therapeutic benefit aim:~      Decitabine (DAC) with or without Hydroxyurea (HY) versus HY in patients with advanced~     proliferative Chronic Myelomonocytic Leukemia (CMML)~      The primary objective of the study is to compare between the two arms Event-free Survival~     (EFS).~      Secondary objectives are to compare between both arms:~      Overall Survival (OS) Cumulative incidence of AML Overall and Complete Response Rates at 3~     and 6 cycles according to IWG 2006 criteria modified for CMML Response duration Toxicity~     (hematological and non hematological) Prognostic factors~   "
103367|NCT02214394|"~     This study involves the use of an experimental device which will measure how much propofol is~     present in your exhaled breath during surgery compared to how much is in your blood. The~     study results will look at whether the device is as accurate as conventional methods for~     measuring propofol levels during surgery.~   "
103368|NCT02214381|"~     Comparison of pre-surgical Myocet/ Cyclophosphamide (MC) q3w followed by either MC or~     Paclitaxel - depending on early response assessment by ultrasound or by toxicity for elderly~     non frail primary breast cancer patients with increased risk of relapse.~   "
103369|NCT02214368|"~     The investigators assessed the efficacy and safety of this noninvasive Ventilation (NIV)~     bundle strategy compared with a conventional treatment in postoperative patients with ARF.~   "
103370|NCT02214342|"~     The aim of the present study is to evaluate an innovative virtual reality-based balance~     training intervention for improving clinically relevant motor performances (balance and gait)~     in people with mild cognitive impairment.~      The investigators hypothesize that the virtual reality-based balance training intervention~     will improve balance and gait performances in people with mild cognitive impairment compared~     to a control group receiving usual care only.~   "
103371|NCT02214329|"~     Diabetic peripheral neuropathy (DPN) can severely deteriorate balance and gait in patients,~     thereby increasing risk of fall and injury. The aim of the study is to evaluate the efficacy~     of a virtual reality game based exercise training for improving postural body sway and gait~     in diabetes patients with peripheral neuropathy. The exercise training has been specifically~     designed for DPN patients with lost lower extremity joint perception and uses~     state-of-the-art inertial sensors (body-worn) to acquire joint movement and provide real-time~     joint feedback through an interactive interface on a LCD monitor. The investigators~     hypothesize that tailored exercise with real-time visual joint feedback during exercise will~     reduce improve balance and gait.~   "
103372|NCT02214316|"~     Children with concussion may improve with intravenous fluids.~   "
103373|NCT02214303|"~     The prevalence of allergic diseases, especially airway allergic diseases, has increased~     dramatically over the last twenty years all over the world including Lithuania. Allergic~     diseases are associated with significantly reduced quality of life and can sometimes cause~     death. Allergic diseases have turned into an important economic and social burden and~     nowadays take a more and more important place in the health system. Despite all intensive~     investigations, the pathogenesis of allergic airway diseases still remains unclear. As~     allergic diseases have a systemic pattern and multicomponent pathogenesis, it is important to~     investigate not individual cells, but examine various inflammatory cells instead, including~     their biological products and possible cellular interactions along the course of allergic~     diseases. This research focuses on the cells that are claimed to be important in the~     pathogenesis of allergic airway diseases, i.e. a newly found effector T helper cell subset~     (Th9 cells), which still lacks deeper investigation, and the main inflammatory cell,~     eosinophil. This study aims at determining the importance the way the Th9 lymphocytes~     perform, the eosinophil's activity, as well as molecular factors affecting these cells has in~     the process of prognostication of allergic airway diseases, namely allergic rhinitis and~     allergic asthma. An allergen challenge test will be performed in order to define the meaning~     of pathogenetic changes. The results of this research may reveal useful information in the~     course of allergic diseases and may be valuable when creating strategic principles of~     prophylaxis. The findings could be used for prevention and early diagnostics of allergic~     diseases and it could also open doors to discovering new and effective treatment.~   "
103386|NCT02214134|"~     SPECTAlung is a program aiming at screening patients with thoracic tumors to identify the~     molecular characteristics of their disease. The thoracic tumors include lung cancer,~     malignant pleural mesothelioma, thymoma or thymic carcinoma at any stage. Once the molecular~     characteristics are identified, there might be the possibility to offer these patients access~     to targeted clinical trials.~   "
109123|NCT02139098|"~     The purpose of this study is to evaluate whether drug efficiency of zolpidem and~     amitriptyline can be conditioned according to learning theory in patients with primary~     insomnia.~   "
103374|NCT02214290|"~     Caffeine is an exceedingly popular and consumed pharmacological agent. Although caffeine is~     primarily consumed from coffee and tea beverages, it is also available in other forms such as~     sodas, energy drinks, tablets and capsules. Nevertheless, caffeine acutely increases brachial~     and aortic systolic blood pressure (BP) and arterial stiffness. Arterial stiffness is an~     independent predictor of cardiovascular disease (CVD) and assessed through pulse wave~     velocity (PWV). Interestingly, previous studies have proposed that caffeine may increase~     aortic BP through increases in aortic PWV and augmentation index (AIx), a measurement of wave~     reflection. Yet, these effects were seen in middle-aged adults with treated hypertension and~     a wide age range. Therefore, it is imperative to consider that caffeine may cause different~     effects in young normotensive individuals than in older adults independently of BP levels.~     Importantly, oral supplementation of the amino-acid, L-citrulline has been shown to enhance~     the bioavailability of L-arginine levels and nitric oxide (NO) production and, therefore,~     improve arterial function. L-citrulline supplementation for 7 days given at 6 g/day has shown~     to increase NO levels while improving PWV. Previous studies by our group also demonstrated~     that L-citrulline supplementation reduces the BP response to cold exposure; a condition with~     an increased vasoconstriction. Therefore, the acute effects of caffeine on central and~     peripheral PWV and BP in healthy young men are yet to be fully evaluated. We hypothesized~     that acute caffeine intake would increase peripheral and aortic BP and PWV and that~     L-citrulline supplementation would attenuate the effects induced by acute caffeine ingestion.~   "
103375|NCT02214277|"~     The Sentinel System will be a safe and effective method for capturing and removing embolic~     material (thrombus/debris) during transcatheter aortic valve replacement in order to reduce~     the ischemic burden in the cerebral anterior circulation.~   "
103376|NCT02214264|"~     The purpose of this study is to evaluate and compare the effectiveness of several brief~     trainings based on contemplative practices and positive psychology to buffer against the~     negative effects that acute stress has on behavior and cognitive abilities. The investigators~     hypothesize that training will buffer against negative effects of acute stress.~   "
103377|NCT02214251|"~     We aim to investigate the higher level mechanism of gait disorders in PD patients by~     ambulatory recording of electroencephalographic (EEG) and leg electromyographic (EMG) signals~     during unconstrained walking. Independent component analysis will be conducted for signal~     analysis. The connectivity among different brain regions will also be investigated. The PD~     patients received deep brain stimulation will be recruited for the study. The local field~     potentials recorded from sub-thalamic nuclei and/or PPN will be recorded concomitantly with~     EEG and leg EMG signals during unconstrained walking in PD patients to assess the roles of~     these deep structures in ambulation and their functional connectivity with other brain~     regions during walking.~   "
103378|NCT02214238|"~     This study will test the hypothesis that the modified positive airway pressure (PAP) device~     for OSA will be no worse than a market released product in terms of its treatment efficacy,~     comfort and patient compliance. Patients will have their treatment pressure titrated using~     polysomnography (PSG) in the sleep laboratory, and then in a random order will spend~     additional time undergoing PSG using both devices, and using both devices at home for 3~     weeks. Data will be collected from the PSG studies, device downloads, independent~     pressure-flow loggers, and custom questionnaires.~   "
103379|NCT02214225|"~     This is a study to assess the immune (antibody) response and safety of a bioCSL split virion,~     inactivated quadrivalent influenza vaccine, in comparison with a US licensed 2014/2015~     trivalent influenza vaccine (bioCSL TIV-1), and a trivalent influenza vaccine containing the~     alternate B strain (bioCSL TIV-2), in healthy adult volunteers aged 18 years and above.~   "
103380|NCT02214212|"~     This study proposes to investigate how well Bright White Light Therapy will work in the acute~     inpatient rehabilitation units for people whom have experienced a traumatic brain injury for~     the purpose of treating sleep disruption. Participants will be assessed based on sleep~     efficiency, thinking abilities, therapy participation, and perception of fatigue/sleepiness.~     In previous studies dim red light has not had the same effects on function as bright white~     light, and will be chosen for use as a placebo. Each subject will be randomized to receive 30~     minutes of either Bright White Light Therapy or Red Light Treatment each morning for 10 days.~      To measure the effect of this treatment, the investigators will measure the each participants~     sleep daily by using an actigraph watch. This watch will record movement continuously. The~     investigators will also measure the subjects' report of how well they slept, whether fatigue~     is present, and how attentive they are before and after treatment.~      Research Hypothesis:~      In persons with TBI, prospectively compare overnight sleep in a cohort exposed to morning~     Bright White Light with a comparison group exposed to Red Light in an acute inpatient~     rehabilitation setting.~   "
103381|NCT02214199|"~     The objective of this protocol is to compare degree of improvement can be achieved in~     patients with shoulder pain by treatment with Manipulative Techniques for the cervicothoracic~     spine versus home exercises.~   "
103382|NCT02214186|"~     Introduction: Pre-eclampsia is a multifactorial syndrome which occurs in hypertension and~     proteinuria in pregnant women over 20 weeks gestation. It is the leading cause of maternal~     complications such as pulmonary edema, which occurs in about 3% of severe preeclamptic having~     as one of the causes volume overload. Anesthetic procedures are frequent in this population,~     with replacement with crystalloid of the duct during cesarean section under spinal anesthesia~     for combat hypotension and hypovolemia manifested by oliguria. However, as water therapy have~     antagonistic effects on cardiopulmonary and renal systems is no doubt as to the benefits~     compared to conventional or restrictive pattern of fluid therapy on renal function.~     Objective: To compare the renal function of patients with severe preeclampsia who received~     restrictive fluid therapy during caesarean section, as well as evaluating the use of cystatin~     C and Neutrophil gelatinase-associated lipocalin (NGAL) as a predictor of renal damage in~     this population. Hypothesis: Intraoperative fluid restriction did not influence renal~     function of patients with severe preeclampsia undergoing cesarean section under spinal~     anesthesia.~   "
103383|NCT02214173|"~     The purpose of this study is to investigate the effects of the nutritional supplement rice~     bran arabinoxylan compound (RBAC) on metabolic syndrome variables in persons living with HIV.~     The hypothesis is that there will be a significant improvement in metabolic syndrome and~     immune variables in HIV-positive participants in the intervention group compared to the~     control group.~   "
103389|NCT02214095|"~     This study is the first evidence based work evaluated the systemic use of glucosamine as an~     adjunctive therapy to closed mechanical debridement in chronic periodontitis. The use of~     glucosamine sulphate was correlated with clinical outcomes and IL1-β level in the GCF of~     patients with moderate to advanced chronic periodontitis~   "
103390|NCT02214082|"~     Study intends to determine if there is any difference in the occurrence of major adverse~     cardiology events in patients discharged on the same day as their elective cardiac~     angioplasty or discharged one day after their angioplasty.~      Hypothesize that same day discharge is as safe as a day later discharge.~   "
103391|NCT02214069|"~     The purpose of this study is to examine whether patients can use the AliveCor case to record~     their heart rhythm and to assess the accuracy of the software in detecting AF vs sinus rhythm~   "
103392|NCT02214056|"~     The main objective of this study is to assess the feasibility of standardized screening for~     comorbidities among patients with one or more of three chronic diseases (diabetes, COPD,~     atherosclerosis) by a mobile unit at times and localities under-served by health actors.~   "
103393|NCT02214043|"~     There are no special clinical characteristics of acute pulmonary embolism in Chinese~     population.~   "
103394|NCT02214030|"~     This study was performed to evaluate the safety and efficacy of a locally designed Assiut~     Femoral Compression Device (AFCD) versus manual compression (MC). Femoral compression devices~     have been developed thorough the past decades without being strongly implemented in the~     catheterization laboratory. Their limited adoption reflects concerns of high cost and~     conflicting data regarding their safety~   "
103395|NCT02214017|"~     Progress in technology has made telemedicine-based solutions with video consultations~     available in the management and treatment of chronic diseases like diabetes, heart failure~     and lung insufficiency at home. However, no direct comparisons on health outcomes of~     telemedicine using video consultations versus usual outpatient treatment are available.~      We wanted to implement a model of telemedicine and to evaluate health indicators in type 2~     diabetes patients treated by video consultations or the standard outpatient treatment~   "
103396|NCT02214004|"~     The purpose of this study is to evaluate whether trastuzumab and letrozole are effective and~     safe in the preoperative treatment for postmenopausal patients with hormone receptor-positive~     and HER2-positive breast cancer.~   "
103397|NCT02213991|"~     The purpose of this study is to evaluate acute local toxicity of IORT at the dose of 20 Gy~     for the replacement of boost-external beam radiotherapy in Korean women who are candidates~     for breast-conserving treatment.~   "
103398|NCT02213978|"~     The purpose of this study is to analyze the effect of the prophylaxis of venous~     thromboembolism in the critical ill patients, and at the same time, to find out the risk of~     venous thromboembolism and hemorrhage events occurred under the prophylaxis.~   "
103399|NCT02213965|"~     A peripheral intravenous catheter is the most commonly used vascular access device in~     medicine. Primary objective is to compare insertion and handling of two peripheral~     intravenous catheters in clinical routine.~   "
103400|NCT02213952|"~     INTRODUCTION: Vascular ulcers are an important pathology in the daily medical practice in all~     the assistance levels, and they have big repercussion referring to individual, social and~     labour levels, supposing a big consumption of human and material resources.The cure with~     autologous platelet rich plasma (autologous PRP) has demonstrated in different studies a~     decrease in the cicatrization time comparing to conventional methods in hospital levels,~     which becomes interesting contrasting its efficacy in primary care.~      AIM:Evaluate the efficacy of the autologous PRP in the treatment of vascular ulcers,~     comparing to the conventional treatment ( cure with humid environment), in primary care~     patients with chronic venous insufficiency in C-6 degree (CEAP classification).~      DESIGN: A study will be executed, which will consist in a randomized clinical test,~     multicentered, in parallel groups and opened. 150 patients suffering of venous vascular~     ulcers will be studied, who will be between the age of 40-100 years old, and who will be~     attached to 10 health centers. Variables for the identification, following, result and~     patient profile have been defined. Emphasize the variables of ulcer area decreasing, CIVIQ~     index, % one cure per week.~   "
103401|NCT02213939|"~     Cardiac surgery leeds to a systematic inflammatory response induced by the surgical trauma~     and the use of the cardiopulmonary bypass (CPB). Activation of inflammatory cascades can~     cause a systemic inflammatory response syndrome (SIRS) which is associated with increased~     morbidity and mortality. Therefore, strategies to reduce the inflammatory response have a~     potential benefit for cardiac surgery patients.~      The clinical benefit of reducing proinflammatory cytokines such as IL-6, Il-8 and TNF-a with~     the use of a cytokine adsorbing circuit (Cytosorb) during CBP remains unclear. Therefore, the~     investigators conduct this prospective, observational pilot study to determine the clinical~     impact of the use of a cytokine adsorbing circuit during CBP.~   "
103402|NCT02213926|"~     The purpose of this study is to characterize the safety and efficacy profile of ACP-196~     (acalabrutinib) in subjects with relapsed or refractory Mantle Cell Lymphoma (MCL).~   "
103403|NCT02213913|"~     This phase I/II trial studies the side effects and best dose of lenalidomide when given~     together with combination chemotherapy and to see how well they work in treating patients~     with v-myc myelocytomatosis viral oncogene homolog (avian) (MYC)-associated B-cell lymphomas.~     Lenalidomide may stop the growth of B-cell lymphomas by blocking the growth of new blood~     vessels necessary for cancer growth and by blocking some of the enzymes needed for cell~     growth. Biological therapies, such as lenalidomide, use substances made from living organisms~     that may stimulate or suppress the immune system in different ways and stop cancer cells from~     growing. Drugs used in chemotherapy, such as etoposide, prednisone, vincristine sulfate,~     doxorubicin hydrochloride, cyclophosphamide, work in different ways to stop the growth of~     cancer cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Monoclonal antibodies, such as rituximab, may block cancer growth in~     different ways by targeting certain cells. Giving lenalidomide together with combination~     chemotherapy may be an effective treatment in patients with B-cell lymphoma.~   "
103716|NCT02209792|"~     The primary objective of this extension study was to obtain long-term safety data for BIRB~     796 BS in patients with moderate to severe Crohn's disease after 26 weeks of treatment.~     Secondary objectives were the evaluation of efficacy of BIRB 796 BS to induce clinical~     remission and response over 26 weeks of treatment.~   "
103404|NCT02213900|"~     The purpose of this study is to investigate the effectiveness of a preventative low-dose of~     Haloperidol to prevent delirium in patients undergoing a esophagectomy, pneumonectomy or~     thoracotomy.~      Delirium is state of severe confusion and some symptoms include:~        -  Cannot think clearly~        -  Have trouble paying attention~        -  Have a hard time understanding what is going on around them~        -  May see or hear things that are not there. These things seem very real to them.~   "
103405|NCT02213887|"~     The purpose of this 9-day study is to determine if:~        1. Pantoprazole modifies the steady-state plasma concentrations of orally administered~          psychotropic medications including valproic acid, lithium, and second-generation~          antipsychotics (i.e., aripiprazole, asenapine, clozapine, lurasidone, olanzapine,~          paliperidone, quetiapine, risperidone, ziprasidone)~        2. Serum gastrin levels change within a week of starting or stopping pantoprazole~   "
103406|NCT02213874|"~     The purpose of this research is to understand the relationship between trust in the health~     care system and choice of contraception during the postpartum period among pregnant women~     receiving prenatal care.~      Research subjects will complete a questionnaire at enrollment and between delivery and within~     5 days of hospital discharge.~      A chart review will also be completed to gather use of a birth control method at the six week~     postpartum visit as well as pertinent medical diagnoses and recorded data such as height,~     weight, body mass index, and contraceptive plan as documented in the postpartum medical~     chart.~   "
103407|NCT02213861|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of SHAPE~     administered topically to skin lesions in patients with early-stage cutaneous T-cell lymphoma~     (CTCL).~   "
103408|NCT02213848|"~     The purpose of this study is to evaluate the effect of calcium chloride against residual~     neuromuscular blockade at the end of general anesthesia~   "
103409|NCT02213835|"~     The aim of this study is to determine the tolerability and potential efficacy of dietary~     therapy, the Specific Carbohydrate Diet (SCD), in pediatric patients with Crohn's disease~     (CD) and Ulcerative Colitis (UC). This is a single center, open labelled study designed to~     determine tolerability, preliminary safety and potential efficacy in pediatric patients with~     CD and UC. The study patients will be recruited from Seattle Children's GI clinic. the~     investigators will enroll 10 patients with mild to moderate CD (defined as PCDAI score of~     10-29) or Ulcerative colitis (PUCAI 10-60) ages 8 to 21 years. Each patient will be in the~     study for approximately 12 weeks.~   "
103410|NCT02213822|"~     The purpose of this study is to discover genetic changes associated with different cancers.~     With the information from this study the investigators hope to provide better ways to~     prevent, detect and treat many cancers.~      Many diseases can result from changes in a person's genetic material that causes cells to not~     work properly. Currently, researchers and doctors know some of the genetic changes that can~     cause disease, but they do not know all of the genetic changes that can cause disease.~      This project is designed to identify genetic changes that can cause cancer in humans.~     Specimens will be collected from a scheduled diagnostic or routine (i.e. blood draw for~     counts) procedure and may include samples from the tissue itself (surgery), bone marrow,~     blood, saliva, urine, spinal fluid, sputum, joint fluid, seminal fluid, ascites (a fluid that~     fills up in the abdomen), and/or pleural fluid (fluid in the lung cavity), to either confirm~     the diagnosis of cancer or to help to decide how best to treat cancer or other illness.~     Additionally archived tissue may be analyzed. Samples may be stored for future use in later~     experiments. The Department of Pathology at Rhode Island Hospital will store the samples.~      Information from the medical record, such as responses to treatments or family history of~     cancer, will be collected.~   "
103411|NCT02213809|"~     Background:~      COPD is an inflammatory and chronic obstructive lung disease, mainly caused by smoking. Most~     patients with COPD are discovered and treated in primary health care. Co-morbidity with heart~     disease, hypertension, diabetes, osteoporosis and underweight is common. It is important to~     diagnose COPD at an early stage, primarily to motivate smoking cessation, which is the most~     important factor for decelerating the progress of COPD. In addition, medication and~     rehabilitation to reduce symptoms of COPD can be given. Previous studies in Sweden have shown~     poor quality of primary health care provided to patients with COPD.~      As general practitioners often deal with multiple medical problems and patients' motivation~     when diagnosing and treating COPD we hypothesize that case method education (see description~     under intervention) in COPD has better effect than traditional education (see description~     under intervention).This study aims to examine the effect of case method education on (1)~     learning in COPD among general practitioners and on (2) health in their patients with COPD.~      Method:~      Primary health care centers (PHCC) in Stockholm will be recruited. The PHCCs will be~     randomized to either case method education (n=9 PHCCs) or traditional education (n=9 PHCCs)~     in COPD for their general practitioners. The educations will be held during two times (two~     hours each) within a time range of three months, covering examination and treatment of~     patients with COPD. At least 10.000 patients should be listed at PHCCs included. Random~     sampling of 45 patients with COPD at stage 2-3 will be done from each PHCC. The patients will~     fill in a self-assessment questionnaire including CCQ, CAT and LINQ (see outcome measures) as~     well as questions about medication, exacerbations and other chronic diseases. The~     questionnaire will be sent to the patients 1-2 months before the education and 18 months~     after the education. Differences in assessments in the questionnaire before and after the~     education will be compared between the patients listed at the PHCCs that have received case~     method education vs. traditional education. In addition, general practitioners~     (approximately, n=180) at the PHCCs will fill in a questionnaire, immediately before and 12~     months after the education, covering the learning outcomes in order to study differences in~     learning between the two intervention groups.~   "
103412|NCT02213796|"~     This is a prospective, noncomparative study to assess the pharmacodynamics of meropenem~     during early phase of severe sepsis and septic shock in critically ill patients in an~     intensive care unit.~      Clinical and laboratory data such as age,sex, body weight, electrolyte, vital signs, APACHE~     II score, SOFA score, BUN, Cr and blood culture will be collected.~      Twelve patients will be enrolled in this study. Meropenem pharmacokinetic will be carried out~     during the first and second dose after 1g meropenem administration. Blood samples~     (approximately 3 ml) will be obtained by direct venepuncture at the following time: 0, 0.25,~     0.5, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 8, 8.5, 9, 9.5, 10, 12, 14 and 16 h.~      Meropenem assays will be performed by modified method of Ozkan et al. (Biomed. Chromatogr.,~     2001).~      The pharmacokinetics of meropenem will be modelled from concentration-time profile using~     compartmental model. Monte Carlo simulation to assess PK/PD index as 40% and 100% T>MIC will~     be conducted and the results will be reported as % PTA (Probability Target Attainment) and~     %CFR (Cumulative Faction Response)~   "
103413|NCT02213783|"~     This is prospective and randomized study to compare the pharmacodynamics (t>MIC) of 0.5 g~     every 6 h of imipenem in twelve patients with febrile neutropenia following administration by~     a 4 h infusion or bolus injection.~      Concentration of imipenem in plasma will be measured by HPLC method and simulated in Monte~     Carlo technique (Computer model) to get PK/PD index (40%T>MIC) and reported to %PTA~     (Probability Target Attainment) and %CFR (Cumulative Faction Response.~   "
103414|NCT02213770|"~     High-intensity training (HIT) has repeatedly been documented to have superior positive~     effects compared to moderate exercise in patients with coronary heart disease and heart~     failure. Since heart transplant recipients (HTx), have a denervated heart with different~     respond to exercise, HIT has previously not been introduced among these patients.~     Rikshospitalet carried out a RCT to investigate this (the TEX study 2009-2012), and found~     that this form of exercise also was highly effective and safe in long term HTx with~     clinically significant improvement in VO2peak, muscular exercise capasity, general HRQoL, and~     even slower progression of CAV (coronary allograft vasculopathy). Based on these findings we~     ask the following questions in this follow-up study:~        1. Would the effect on VO2peak, HRQoL,muscle capacity and CAV obtained during the study~          period continue during long term follow up (5 years)?~        2. Is the intervention group more physical active after HIT compared to the control group?~   "
103415|NCT02213757|"~     The purpose of this study is to determine if vaginal estrogen use is associated with~     resolution of blood in the urine (microscopic hematuria) in postmenopausal women. The~     hypothesis is that postmenopausal women with blood in the urine (microscopic hematuria) will~     have higher rates of resolution of hematuria after treatment course with vaginal conjugated~     equine estrogen cream compared to placebo cream~   "
103416|NCT02213744|"~     This study is an open label, randomized, multicenter trial of MM-302 plus trastuzumab. The~     trial is designed to demonstrate whether MM-302 plus trastuzumab is more effective than the~     chemotherapy of physician's choice (CPC) plus trastuzumab in locally advanced/metastatic~     HER2-positive breast cancer patients. Patients may not have been previously treated with an~     anthracycline in any setting. Patients must have received prior treatment with trastuzumab in~     any setting, have either progressed or are intolerant to ado-trastuzumab emtansine in the~     metastatic or locally advanced setting, have either progressed or are intolerant to~     pertuzumab in the metastatic or locally advanced setting or had disease recurrence within 12~     months of pertuzumab treatment in the neoadjuvant or adjuvant setting.~   "
103417|NCT02213731|"~     The purpose of this clinical study is to assess the single procedure outcomes of using~     cryoballoon ablation without additional empirical lesions and/or complex fractionated~     electrogram (CFE) ablations for patients with early persistent atrial fibrillation (<1 year~     from first diagnosis of persistent AF).~   "
103418|NCT02213718|"~     This study is to assess the effect of desflurane on myocardial function in patents who~     underwent coronary artery bypass grafting.~   "
103419|NCT02213705|"~     The main ailm of this phase I-II study is to evaluate toxicity and efficacy of allogenic~     mesenchymal stem cell therapy to treat severe systemic sclerosis. In practice this treatment~     will be given to patients with a rapidly evolutive disease or refractory to cyclophosphamide.~   "
103420|NCT02213692|"~     Blood loss during liver resection significantly associates with short term operative outcome.~     The median blood loss during partial liver resection is 700-1200ml in high-volume centers.~     Conventional method (crush-clamp) has been a standard technique for liver transection.~     Technique advances related to liver transection have contributed to reduction in blood loss.~     Several studies have showed that Harmonic Scalpel in liver resection is safe and easy to use.~     A nonrandomized study showed use of the Harmonic Scalpel was associated with decreased~     operative time, blood loss and transfusion requirement, and an increased incidence of~     postoperative bile leakage. However, no randomized study has compared the difference between~     liver resection using traditional technology and harmonic Scalpel. The objective of this~     prospective randomized study is to compare the safety and efficacy of liver resection using~     the harmonic scalpel device with the crush-clamp technique in respect to blood loss, liver~     transection time, hepatic hilum clamping time, hospital stay and postoperative complications.~   "
103421|NCT02213679|"~     Chronic fatigue syndrome (CFS) is a debilitating condition of unknown etiology. Recent~     studies have shown that CFS is associated with impaired cellular energetics and low levels of~     phosphocreatine. Since guanidinoacetic acid (GAA) acts as a highly bioavailable precursor of~     creatine it may provide an ideal dietary supplement to facilitate treatment and perhaps~     prevention of CFS. The overall hypothesis to be evaluated is that medium-term supplementation~     with GAA will improve clinical outcomes in well-defined adult CFS patients via augmented~     provision of creatine. Specific aims: (1) To determine the effects of GAA on CFS~     symptomatology using a fatigue severity inventory, soreness of locomotive apparatus scales,~     and a health-related quality of life survey; (2) To determine the effect of GAA on creatine~     metabolism using laboratory studies and magnetic resonance spectroscopy; (3) To characterize~     the physiological effects of GAA on work capacity via actigraphy and exercise performance~     tests; and (4); To determine the prevalence of subjectively reported side-effects and~     biochemical adverse events associated with GAA intervention.~   "
103422|NCT02213666|"~     The presence of intracardiac thrombi and their propensity for systemic embolism is a major~     concern in patients with atrial fibrillation (AF) and atrial flutter (AFL) undergoing~     cardioversion and ablation procedures. Transesophageal echocardiography (TEE) is the clinical~     gold standard imaging modality for visualization of the right atrial appendage (RAA) and left~     atrial appendage (LAA) for detection of thrombi as well as risk factors associated with~     thrombus formation, including spontaneous echo contrast and low LAA velocity. However, TEE is~     a moderately invasive procedure that incurs additional risk, cost, and patient discomfort. In~     addition, thrombus detection via TEE may be ambiguous, and another tool capable of confirming~     uncertain TEE findings is desirable. This is particularly crucial in cases when adequate LAA~     imaging cannot be acquired or if TEE is clinically contraindicated, requiring alternative~     imaging modalities that can visualize these structures.~      Phased-array intracardiac echocardiography (ICE) provides high-imaging resolution and is~     routinely used during atrial fibrillation (AF) ablation procedures for transseptal puncture~     and periprocedural catheter visualization. A majority of imaging acquired during AF ablation~     is performed with the ICE catheter in the right atrium (RA). However, these standard views~     are often unable to provide sufficient visualization of the LAA structure due to the~     relatively long distance between the ICE catheter and LAA.~      Placement of the ICE catheter in the pulmonary artery (PA) provides improved visualization of~     the LAA over other locations by reducing the anatomic distance between the imaging catheter~     and structure of interest. Recent retrospective studies have confirmed improved assessment of~     the LAA with ICE imaging from the PA and equivocal sensitivity and specificity when compared~     with TEE for evaluation of LAA thrombus. However, these studies did not systematically~     evaluate the presence of SEC, flow velocity, the LAA dimensions, or the RAA.~      Although these studies support the use of ICE imaging from the PA to clarify or confirm TEE~     findings, a prospective and blinded study evaluating both the LAA and RAA in its entirety is~     required. We hypothesize that this prospective and blinded study will confirm ICE as~     non-inferior to TEE in the assessment of LAA and RAA structure and for the detection of~     thrombi.~   "
103450|NCT02213289|"~     The purpose of this study is to determine if doctors can use the results of special tests of~     subjects tumor tissue, that will look for specific abnormalities in the tumor, to choose a~     specific drug that is targeted to work against that abnormality (called molecular profiling)~     and to see what effects (good and/or bad) that targeted drug has on subjects cancer when it~     is given with standard chemotherapy.~   "
103423|NCT02213653|"~     Anemia in patients with cancer is a common problem associated with an impaired quality of~     life.~      Treatment with erythropoiesis stimulating agents (ESA) allows an increase in hemoglobin~     levels in 40-70% of patients and decreased transfusion requirements.~      Absolute or functional iron deficiency is also common with about 30% of cancer patients with~     all histologies combined iron deficiency and anemia.~      Several studies have shown the benefits of the combination of intravenous iron to~     erythropoiesis-stimulating agents in improving hemoglobin. However, none of them, to the~     investigators knowledge, has not been specifically performed on a population of patients with~     functional iron deficiency.~      In addition, in clinical practice, this association is not carried out in particular because~     there is no dosage or consensus sequence for the administration of iron associated with ESAs.~   "
103424|NCT02213640|"~     Following stroke, over 50% of patients keep severe neurological deficiency whose unilateral~     neglect, mostly following a right hemispheric lesion. The prismatic adaptation involves to~     pointing movements toward visual targets wearing prismatic glasses. These prismatic glasses~     induce a shift to the right visual field for improving symptoms in short term.~      Transcranial direct stimulation (tDCS) has been evaluated for different types of deficiency~     resulting from stroke with encouraging results. The hypothesis of the study is to evaluate~     the usefulness of brain stimulation as an adjunctive intervention to optimize and increase~     the rehabilitation of unilateral neglect to long-term.~      Thus, the main objective is to evaluate the effectiveness of standard treatment with~     prismatic adaptation with anodal tDCS or sham tDCS.~   "
103425|NCT02213627|"~     The purpose of this study is to determine if corifollitropin alfa (long-term gonadotropin~     administration) is effective in a controlled ovarian stimulation protocol in oocyte donors~     compared to daily gonadotropin administration (recombinant FSH or HP-hMG)~   "
103426|NCT02213614|"~     The word lithium frequently conjures images of catatonic psychiatric patients and side~     effects so severe that premature death is commonplace. But naturally occurring lithium is a~     far cry from pharmaceutical grades. Found in the soil, water and certain foods, it is an~     essential mineral for maintaining physical and mental health. When exposure is low, suicide~     rates, mental illness and violent crime increase~   "
103427|NCT02213601|"~     The aim of this project is to compare the efficacy of an 8-week yoga intervention, relative~     to a wait-list control (WLC) condition, for improving psychological functioning and~     health-related quality of life in depressed postpartum women. It was hypothesized that the~     yoga intervention would be significantly more efficacious than the wait-list control~     condition in reducing symptoms of depression and anxiety, and improving health-related~     quality of life, at the end of the 8-week yoga intervention.~   "
103428|NCT02213588|"~     This study evaluates the response to oxidative stress in healthy men and women after taking a~     blend of plant concentrate.~   "
103429|NCT02213575|"~     This study is a mechanistic study that will enroll 9 subjects who are participating in~     NCT02133885 (which is designed to evaluate minocycline to test the hypothesis that~     minocycline treatment would produce antihypertensive effects in drug-resistant neurogenic~     hypertensive individuals) to test whether the antihypertensive effect of minocycline is~     associated with a decrease in activated microglia in central nervous system autonomic regions~     as evidenced by changes in PET and MRI imaging.~   "
103430|NCT02213562|"~     The aim of this study is to investigate the efficacy and dose-dependency of chrysanthemum~     flower oil in suppressing serum uric acid.~   "
103431|NCT02213549|"~     This study is designed to evaluate the effect of ume paste and ginger powder on glucose~     metabolism in prediabetic subjects.~   "
103432|NCT02213536|"~     To investigate the use of a scalp sparing technique of radiotherapy treatment designed to~     treat the whole brain. Current treatment methods to treat the whole brain with radiotherapy~     result in complete alopecia as a side effect. Hair loss is usually patchy and uneven and~     re-growth similar and slow.~      It is hoped that reducing the radiation dose to the hair bearing follicle on the scalp will~     reduce hair loss and increase the speed and evenness of re-growth.~   "
103433|NCT02213523|"~     This is a proof of concept study that evaluates the response to oxidative stress in healthy~     men after taking plant concentrates.~   "
103434|NCT02213510|"~     ZipLine Medical, Inc. has developed a novel, non-invasive skin closure device called Zip~     Surgical Skin Closure to replace sutures, staples and glue for closure of the skin layer for~     surgical incisions or laceration repair. The study will be comparing the Zip Surgical Skin~     Closure to standard sutures in patients undergoing cardiovascular implantable electronic~     device (CIED) procedures on outcomes including closure time, cosmetic appearance of resulting~     scar, and overall cosmetic appearance of scar. The study will be following participants for 3~     months following CIED procedure.~   "
103435|NCT02213497|"~     Patients with esophageal cancer to be treated with concurrent preoperative proton therapy~     along with carboplatin and paclitaxel.~   "
103436|NCT02213484|"~     The primary objective of this study is to determine whether specific patterns of circulating~     micro-ribonucleic acids (miRNAs) are associated with aortic aneurysm and dissection in~     patients with hereditary aortopathy syndromes. The most common of these syndromes is Marfan~     Syndrome (MFS), but several other recognized aortopathy syndromes are well characterized. The~     investigators propose the use of a simple blood test, from which miRNA profiles can be~     measured in individuals with aortopathy syndromes to be compared with miRNAs observed in a~     control population that has no known predisposition for aortic disease. The investigators~     hypothesize that microRNA profiles in individuals with Marfan syndrome, and related~     disorders, will be distinct from those seen in a control group. The investigators predict~     that up- or down-regulation of certain miRNAs will correlate with the presence and severity~     of aortic aneurysm, responses to medical therapy, and ultimately could be used to determine~     when an individual may be at risk of dissection.~   "
103437|NCT02213471|"~     Effective communication between physician and patient is fundamental to effective care. The~     recent introduction of electronic patient on-line portals has the potential to change the~     communication landscape. The investigators surveyed patients to assess their preferred~     modality for biopsy notification at 3 institutions with differing patient access to on-line~     portals, to ascertain what patient preferences are currently and if it has changed from~     historical preferences. Our hypothesis is that as patients become more familiar with ln-line~     portals, their preferences will likely reflect familiarity with this modality.~   "
103438|NCT02213458|"~     This is a 3 year clinical trial evaluating the benefits of a program that supports model care~     for patients with dementia and their family caregivers. Subjects will be recruited from~     several sites in San Francisco. Subjects determined to be eligible will be consented and~     randomized into one of two groups. Two thirds of patients will be enrolled into Navigated~     Care that provides them with assistance in meeting important benchmarks in their care, for~     example completion of legal and financial planning and strategies for minimizing caregiver~     burden. One third of patients will be enrolled to a control group, entitled Survey of Care.~     Outcomes include quality of life, health care utilization, caregiver burden, and satisfaction~     with care.~   "
103439|NCT02213432|"~     The purpose of this study is to determine the timing of influenza vaccination to induce~     higher antibody response in adult patients with non-hematologic malignancies receiving~     scheduled cytotoxic chemotherapy.~   "
103440|NCT02213419|"~     Due to widespread use of cross-sectional imaging modalities, pancreatic cysts are common in~     abdominal image. These lesions encompass a wide spectrum, ranging from benign to malignant.~     The diagnosing specific type of cystic lesion is limited in spite of recent advances of~     diagnostic modalities. Surgical resection is generally recommended for malignant and~     potentially malignant lesions. However, surgical resection has significant morbidity and~     sometimes mortality. Recently, a few study of EUS-guided ethanol lavage for cystic tumors of~     the pancreas reported that complete resolution was achieved in only one-third of patients.~     Ethanol lavage of pancreatic cysts may be alternative method to surgical resection.~      The purpose of this study is the double ethanol lavage is a safe and effective method for~     treatment in those with the indeterminate pancreas cysts.~   "
103441|NCT02213406|"~     This project will examine neuronal and sensory fat perception. Our hypothesis is that~     subjects being either hypersensitive or hyposensitive for fat will show different brain~     activities. Therefore the investigators will conduct functional magnetic resonance imaging~     (fMRI) and fat detection threshold tests examining neuronal and sensory fat perception.~   "
103442|NCT02213393|"~     The objective is to study the effectiveness of supplementing a standard hospital and 12-week~     home menu with protein-enriched Cater with Care products in reaching a protein intake of~     1,2-1,5 g/kg body weight/day and in improving functional status after hospital stay in~     elderly patients.~   "
103443|NCT02213380|"~     The purpose of this study is evaluate postoperative delirium after general anesthesia and~     regional anesthesia in elderly patients undergoing hip fracture surgery. Our research~     hypotheses are: (1) regional anesthesia may contribute to decrease the incidence of~     postoperative delirium. (2) Regional anesthesia may improve the outcome of elderly patient~     and reduce healthcare costs associated with postoperative delirium. (3) Postoperative~     delirium may result in poor long-term functional outcomes.~   "
103444|NCT02213367|"~     Chronic spontaneous urticaria (CSU), formerly also known as chronic idiopathic urticaria and~     chronic urticaria (CU), is one of the most frequent skin diseases. At any time, 0.5-1% of the~     population suffers from the disease. Although all age groups can be affected, the peak~     incidence is seen between 20 and 40 years of age. The duration of the disease is generally~     several years but is likely to be longer in more severe cases, cases with concurrent~     angioedema, in combination with physical urticaria or with a positive autologous serum skin~     test (autoreactivity). CSU has major detrimental effects on quality of life, with sleep~     deprivation and psychiatric comorbidity being frequent. It also has a large impact on society~     in terms of direct and indirect health care costs as well as reduced performance at work and~     in private life.~   "
103445|NCT02213354|"~     This is a Phase II randomized, partially-blinded, controlled trial in 360 (up to 600) males~     and females, 65 years of age and older, who are in good health and meet all eligibility~     criteria. This clinical trial is designed to assess the safety, reactogenicity, and~     immunogenicity of a monovalent inactivated influenza A/H7N9 virus vaccine manufactured by~     Sanofi Pasteur administered intramuscularly at different intervals and dosages (3.75, 7.5, or~     15 mcg of HA/0.5 mL dose) given with MF59 adjuvant manufactured by Novartis Vaccines and~     Diagnostics. Subjects will receive three doses of the vaccine. Safety, reactogenicity, and~     immunogenicity data will be collected at standard time points with safety follow-up to~     continue through one year post dose 2. Study Duration is approximately 30 months and Subject~     Participation is approximately 18 months. The primary objectives are to (1) assess the safety~     and reactogenicity of different dosages (3.75, 7.5, and 15 mcg of HA/0.5 mL dose) of an~     MF59-adjuv~   "
103446|NCT02213341|"~     The purpose of this study is to assess the responses in the immune system of infants after~     they receive the vaccine against diphtheria, tetanus, and pertussis (DTaP). The investigators~     will do this by studying the immune cells and allergy responses in the blood prior to and~     after receipt of the third DTaP vaccine.~   "
103447|NCT02213328|"~     Truvada (emtricitabine/tenofovir disoproxil fumarate, or FTC/TDF) is a type of antiretroviral~     (ARV) medicine that is commonly used to treat HIV. Truvada is also used as pre-exposure~     prophylaxis (PrEP) to prevent HIV infection in HIV-negative adults. The purpose of this study~     is to evaluate the acceptability, safety, and use of daily Truvada PrEP as part of a~     comprehensive HIV prevention package in healthy, HIV-uninfected adolescents 15 to 19 years of~     age.~   "
103448|NCT02213315|"~     A phase 1 randomized, double blind single-dose study to evaluate the PK and immunogenicity of~     single SC 100 and 150 mg doses of mavrilimumab in healthy adult Japanese subjects.~   "
103449|NCT02213302|"~     Preoperative anxiety is a subjective and painful experience and may have adverse~     psychological consequences and complicate anesthetic management. The aim of the study is to~     show the effect of premedication by midazolam on preoperative anxiety assessed by a visual~     analog scale and by measuring salivary cortisol levels. This study was a monocentric,~     prospective, blind randomized placebo controlled clinical study. Sixty patients, aged 18 to~     79 years, to undergo elective surgery under general anesthesia with tracheal intubation must~     be enrolled and randomized to receive midazolam (0.02mg/kg) or placebo. The primary outcome~     is the reduction in anxiety assessed by a visual analog scale. The secondary outcomes are the~     reduction in salivary cortisol levels, the overall level of anxiety and the evaluation of~     respiratory and hemodynamic adverse effects of midazolam.~   "
103717|NCT02209779|"~     The objective was to determine the effects of BIRB 796 BS on CRP and clinical parameters in~     Rheumatoid Arthritis as measures of efficacy, and on population pharmacokinetics and safety~     parameters~   "
103451|NCT02213276|"~     Diabetes is associated with an increased risk of bone fractures, but current predictors of~     bone fracture seem to underestimate this risk. It is commonly known that increased levels of~     certain biochemical bone markers predict low-energy fractures, but the pattern of these~     markers in diabetics still show heterogeneity and inconsistency. Part of the pathology of~     diabetes is a high blood glucose level, and this can potentially influence bone turnover and~     thereby bone markers. Chronic inflammation in patients with inflammatory bowel disease is~     shown to increase bone resorption, and the same may be the case in diabetics. The purpose of~     this project is to investigate whether glucose has a direct effect on bone markers or an~     indirect effect through intestinal hormones or inflammatory processes.~   "
103452|NCT02213263|"~     This study will compare the safety and effectiveness of PF-05280586 versus rituximab-EU in~     patients with CD20-positive, low tumor burden follicular lymphoma. The primary hypothesis to~     be tested in this study is that the effectiveness of PF-05280586, as measured by the Overall~     Response Rate, is similar to that of rituximab-EU.~   "
103453|NCT02213250|"~     The sample size of 12 male Chinese subjects are based on the CFDA requirement for a China PK~     study and to support the registration in China.~   "
103454|NCT02213237|"~     It has always been a real challenge to treat sepsis in critically ill patients. The mortality~     is as high as 20％ in patients with severe sepsis and 46％ with septic shock develops. Early~     diagnosis and early treatment are the principles. Along with appropriate resuscitation,~     judicious and thoughtful intravenous antibiotic therapy is the critical determinant of~     survival in sepsis and septic shock given that ineffective initial therapy worsens the~     outcome. Blood culture and subsequent susceptibility testing are the gold standard for~     microbiological diagnosis to direct the optimal use of antibiotic. However, this conventional~     approach usually takes 5-7 days to wait for the final report. Positive results were reported~     in only 30% of patients with sepsis and 50 to 60% septic shock. Moreover, the very low~     bacteria level in blood and prior use of antibiotics may prevent pathogen growth.~     Surface-enhanced Raman scattering (SERS) is a novel spectroscopy technique based on Raman~     scattering and localized surface plasma resonance (LSPR), which results in strongly enhanced~     Raman signals derived from molecules attached to nanometre-sized gold (Au) and silver (Ag)~     structures. SERS provides the structural information of biomedical molecules with~     ultra-sensitive characterization down to single molecular level in fast and non-destructive~     manner. The clinical application of SERS in sepsis will first help to recognize pathogens as~     well as their specific drug sensitivity, and then optimally guide the initial antibiotics~     usage. Plasma from twenty blood culture proven Gram positive, negative and Candida cases will~     separately subject to metabolomics profiling and bioinformatics analysis to establish each~     pathogen metabolites profile. The sensitivity and specificity of SERS and metabolomics in~     identifying pathogen and antibiotics-resistant strains will be evaluated. The investigators~     expected both techniques to play a crucial role in modern sepsis treatment and bring great~     impact on mortality reduction.~   "
103455|NCT02213224|"~     The aim of this current study was to assess the therapeutic effects of perindopril and~     telmisartan for hypertensive patients with NAFLD and make comparison between the therapeutic~     effects of these two kind of drugs.~      This study is a randomized parallel control clinical trial which would be carried out in~     Nanfang Hospital, Southern Medical University.~      About one hundred and eighty patients would be randomly assigned to perindopril,telmisartan~     and amlodipine three groups.~   "
103456|NCT02213211|"~     Malaria is an important contributor to ill-health experienced by school-children and may have~     profound consequences for their learning and educational achievement, and there is a small,~     but growing, body of evidence that suggests malaria control can help improve educational~     outcomes. In Malawi, school-aged children are estimated to experience 0.59 clinical attacks~     of malaria each year, equivalent to 2.1 million attacks among Malawian school-aged children.~     To avert this health burden and potential education consequences, Save the Children in~     partnership with the Malawian Ministry of Health is providing treatment of symptomatic~     malaria cases in schools in southern Malawi, as part of the provision of first aid kits~     (known as Learner Treatment Kits, LTKs) in schools. To evaluate the impact of this~     intervention, a cluster randomised trial is being conducted among 58 schools in Traditional~     Area Chikowi in Malawi, over 12 months. Twenty nine schools are randomly selected to receive~     LTKs, which include malaria rapid diagnostic tests (RDTs) and artemisinin-based combination~     therapies (ACTs) to treat uncomplicated malaria, and 29 schools serve as the control group.~     The primary outcome is school attendance, with secondary outcomes of grade repetition, school~     drop-out and enrolment as well as morbidity, Plasmodium falciparum infection and anaemia. The~     study aims to conduct several quantitative and qualitative assessments to help evaluate the~     external validity of the findings.~   "
103457|NCT02213198|"~     The cost of serious mental illness (SMI) in the U.S. is $317 billion annually. This~     translates to more than $1000 for every man, women, and child in the U.S. Hospitalization and~     Emergency Room (ER) visits have the highest costs. Outpatient services are overburdened.~     There is a push to get people out of hospitals quickly, while they are still quite ill. These~     factors cause patients to be lost in the transition from inpatient to outpatient care. Many~     individuals are repeatedly rehospitalized or continue to clog emergency rooms in an attempt~     to receive care. The importance of transitional care between inpatient/ER facilities and~     outpatient services to prevent this revolving door phenomenon has been continually stressed.~     There is little research on the best way to accomplish smooth transition to outpatient care.~     We developed a 90-day transitional care clinic (TCC) to address this need. We propose a~     randomized treatment outcome study comparing two transitional service packages within our~     TCC: a Standard Care package versus an Engagement-Focused package that features a novel~     intake procedure and a Shared Decision-Making intervention: Access Group is an intake~     procedure designed to address many of the problems of traditional approaches to post-acute~     treatment engagement, including failure of patients to reach intake appointments. Shared~     Decision-Making (SDM) is a structured approach to provider-patient communication that has~     been shown to increase patient involvement in care and improve outcomes. Despite SMI~     patients' desire to be more involved in their treatment decisions and promising early~     evidence of SDM's effectiveness in SMI, SDM has not been systematically evaluated in~     transitional psychiatric care. In the proposed study, patients referred to TCC will be~     randomized to either Engagement-focused Care or Standard Care. The relative benefit of these~     two approaches will be evaluated in 300 individuals who will be randomized to these two~     treatments in a 2:1 ratio. We hypothesize that attendance at appointments, reported~     satisfaction, shared decision making and quality of life will be higher for engagement~     focused care. The new treatment package is designed to get individuals into treatment quickly~     and to teach them how to be good consumers of mental health treatments going forward.~   "
103458|NCT02213185|"~     The aim is to study the effect of local anaesthesia (EMLA®) on pain associated with sterile~     water injections.~   "
103459|NCT02213172|"~     The purpose of this study is to determine if two different probiotic strains, Lactobacillus~     paracasei HA-196 and Bifidobacterium longum R0175, are effective in helping subjects manage~     the symptoms of IBS~   "
103460|NCT02213159|"~     The purpose of this study is to determine if Dexmedetomidine given at the end of surgery will~     reduce postoperative morphine consumption and improve postoperative quality of recovery as~     compared to morphine in patients undergoing laparoscopic bariatric surgery.~   "
103718|NCT02209766|"~     The purpose of this study is to assess safety, tolerability and pharmacokinetics of D5884~     following administration of single and multiple doses in healthy male Japanese subjects.~   "
103461|NCT02213146|"~     The addition of BioChaperone to already marketed prandial human insulin preparations may~     accelerate the onset and shorten the duration of action due to facilitation of the insulin~     absorption after subcutaneous injection.~      The aim of the trial is to assess the efficacy and safety of BioChaperone human insulin in~     subjects with type 1 diabetes under a dose of 0.2 U/kg.~      This trial is a single center, randomised, double-blinded, three treatment, three-period~     cross-over, 10-hour euglycaemic clamp trial in subject with type 1 diabetes mellitus. Each~     subject will be randomly allocated to a single dose of BioChaperone human insulin 0.2 U/kg, a~     single dose of Huminsulin® Normal 0.2 U/kg and a single dose of Humalog® 0.2 U/kg on 3~     separate dosing visits.~   "
103462|NCT02213133|"~     Open-label, multi-center, single-arm, Phase 2 study of oral selinexor in patients with SCC of~     the head and neck (HN-SCC; Cohort 1), lung (L-SCC; Cohort 2), or esophagus (E-SCC; Cohort 3)~     who have relapsed or have metastasis following chemotherapy.~   "
103463|NCT02213120|"~     The VERTIGO study is likely to help determine characteristics of different types of vertigo~     in patients presenting in the Ear Nose & Throat (ENT) clinics with complaints of dizziness.~     Moreover, it will also help to develop an understanding about the current management~     practices of this condition at local level.~   "
103464|NCT02213107|"~     Determine the effect of enzalutamide and dutasteride on the time to prostatic-specific~     antigen level increase in patients age 65 or older.~   "
103465|NCT02213094|"~     This is an open labeled dose escalation safety study of vitamin B3-amide dietary~     supplementation in pregnant women with hypertensive complications of pregnancy. The~     investigators will enroll 5 pregnant women at 24-36 weeks' gestation with the diagnosis of~     hypertensive complications of pregnancy. If the woman is anticipated to remain undelivered~     for 48 hours after diagnosis she will receive vitamin B3-amide, 500 mg/day in a single daily~     dose, continuing for two weeks or until delivery, which ever occurs first. Maternal blood~     will be collected at baseline and 2 times per week to measure maternal LFTs and study markers~     (nicotinamide metabolites, sFlt-1-Soluble fms-like tyrosine kinase-1 and PlGF). The objective~     of this dose escalation safety study is to determine the safety of vitamin B3 amide dietary~     supplementation during expectant management of hypertensive complications of pregnancy.~   "
103466|NCT02213081|"~     The aim of this research is to assess the benefit of a medication (ulipristal) for~     alleviation of symptoms in women with chronic, endometriosis-related pelvic pain.~   "
103467|NCT02213068|"~     This study is being done to investigate the impact of changing immunosuppressive medications~     from tacrolimus (Prograf®) to belatacept (Nulojix®) between three (3) and six (6) months~     after kidney transplantation. The immune system is the body's defense against infection and~     other disease. After transplantation, the body sees the new organ as foreign and tries to~     destroy or reject it. Immunosuppressive medications help to prevent the immune system from~     attacking the transplanted organ. The primary purpose of this research study is to evaluate~     the effects of three (3) different immunosuppressive treatments on rejection in~     post-transplant kidney recipients. This study will test whether switching from tacrolimus to~     belatacept will improve long-term kidney function.~      Three of the immunosuppressants used in this study- mycophenolic acid (MPA), mycophenolate~     mofetil (MMF) and tacrolimus- are medications approved by the United States Food and Drug~     Administration (FDA) to be used after transplant. All of these medications have been~     routinely used in kidney recipients here at Northwestern University.~      Belatacept (the study drug) has been approved by the FDA for use at the time of transplant.~     However, the use of belatacept in this study is considered investigational as it has not been~     FDA approved for use beginning at 3 months after transplant.~      This study will involve 51 adult kidney transplant recipients at Northwestern.~   "
103468|NCT02213055|"~     -  To evaluate the efficacy of LiceMD for the treatment of head lice in a pediatric~          population.~        -  To evaluate the safety of LiceMD in a pediatric population.~   "
103469|NCT02213042|"~     This is a multicenter, open-label, Phase II study in subjects with Human epidermal growth~     factor receptor (HER2)-positive metastatic breast cancer who received at least 2 prior lines~     of anti-HER2-targeted therapies of which at least one included a Trastuzumab-containing~     regimen. This study is a post-approval commitment with regulatory authorities. It is designed~     to evaluate whether treatment with Dual blockade promotes changes to biomarkers associated~     with immunomodulation. The primary endpoint of the study will be to evaluate changes in~     expression of biomarkers associated with immunomodulation between a pre-treatment biopsy and~     the disease progression biopsy. Secondary efficacy endpoints include overall response rate;~     clinical benefit rate; and progression-free survival (PFS); as well as safety/tolerability.~     All subjects will receive study treatment until disease progression, death, unacceptable~     toxicity, or subject withdrawal. In case of disease progression during the treatment period,~     the subject will be followed-up for 30 days for safety evaluation. In case of study treatment~     discontinuation for any reasons other than disease progression, the subject will be~     followed-up for safety and efficacy assessments until disease progression, new anticancer~     therapy, death, withdrawal of consent or end of study, whichever comes first.~      This study will support a better understanding if the rapidly accumulating evidence for the~     importance of the immune microenvironment in HER2-positive breast cancer and the observed~     immunomodulation in the neoadjuvant setting can be confirmed in the advanced setting and~     support the putative mechanism of action of HER2 dual blockade and its potential function on~     the tumor microenvironment. No formal comparisons between treatment arms will be undertaken.~   "
103470|NCT02213029|"~     This multi-cohort phase I study is designed to assess the pharmacokinetics (PK) and~     pharmacodynamics (PD) of oxytocin and to evaluate epelsiban (GSK557296) potential to reduce~     subendometrial contractractility induced by oxytocin in healthy female subjects. Additionally~     tissues concentrations of epelsiban will be determined from endometrial tissue biopsies. Data~     from this study will inform the identification of the doses of epelsiban to be used in future~     in-vitro fertilization (IVF) clinical studies. Expected number of subjects to be randomized~     are: Cohort 1- 10 subjects, Cohort 2a- 10 subjects for each epelsiban arm 25 milligrams (mg),~     200mg, 5 for placebo, Cohort 2b- 10 subjects per arm with dose to be determined, cohort 3- 6~     subjects. Cohorts 1 and 2 will be double blind (sponsor unblinded) placebo controlled~     cohorts. Cohort 3 will be an open label cohort, cohort 4 will be a double blind (sponsor~     unblinded) placebo controlled cohort.~   "
103471|NCT02213016|"~     The purpose of this study is to evaluate clinical efficacy (affective and cognitive) in~     patients with moderate depression between TMS over the left Dorsolateral Prefrontal Cortex~     (DLPFC) with simulated TMS, as well as clinical response when 5 sessions / week are applied~     vs. 2 sessions / week. All patients will receive 15 TMS sessions as initial treatment (active~     or sham) and respondents will participate in an TMS follow-up on the left DLPFC for three~     months.~   "
103472|NCT02213003|"~     Current islet transplantation into the portal vein of the liver has shown the unique ability~     of islets to stabilize blood glucose levels and prevent severe hypoglycemia in a selected~     group of subjects with Type 1 diabetes. The main limitations of islet transplantation are the~     need for systemic immunosuppression to maintain function and the loss of islet function over~     time. Additionally, many studies have demonstrated that the current site of transplantation~     in the liver is not an ideal site due to several factors. These factors include (1)~     significant liver inflammation following islet infusion; (2) potential for life-threatening~     procedure-related complications such as bleeding and thrombosis; (3) high levels of~     immunosuppressive drugs and GI toxins in the liver contributing to islet toxicity; (4) the~     inability to retrieve islets after infusion; and (5) development of graft dysfunction in a~     number of recipients of intrahepatic allogeneic and autologous islets. The implantation of~     islets into the omentum will allow adequate engraftment of islets onto the omentum and will~     lead to comparable or superior functional and clinical outcomes than in the traditional~     intrahepatic site.~   "
103473|NCT02212990|"~     This study aims to conduct a double-blind, placebo-controlled study to assess the effect of~     prophylactic antipyretics on the immune responses and rates of fever after inactivated~     influenza vaccine (IIV) in children 6 through 47 months of age.~      In this study, 160 healthy children, 6 through 47 months of age, including some children at~     risk of febrile seizure, will be randomized to one of three different treatment arms.~     Children will receive either blinded therapy with prophylactic acetaminophen or placebo~     immediately following and every 4 to 6 hours in the 24 hours after receipt of a dose of IIV~     or open-label ibuprofen every 6 to 8 hours in the 24 hours after receipt of a dose of IIV.~     Children will be followed for the occurrence of fever, fussiness, changes in appetite and~     sleep patterns, and use of medical services on the day of and for two days following~     vaccination. Antibody to influenza antigens contained in the respective 2014-2015 and~     2015-2016 vaccines as measured by hemagglutination inhibition (HAI) antibody will be assessed~     at baseline and four weeks following vaccination. The proportions of children experiencing~     fever, having solicited side effects, using medical services, demonstrating a serologic~     response corresponding to seroprotection and seroconversion to each of the IIV antigens will~     be determined for groups of children in each of the three treatment arms. Likewise geometric~     mean HAI titers (GMTs) and corresponding 95% confidence intervals for each IIV antigen will~     be calculated for the three treatment arms. The investigators hope to learn whether or not~     prophylactic antipyretics affect the immune response and fever rates following IIV.~   "
103474|NCT02212977|"~     Hypothesis is that incision closure with octylcyanoacrylate is inferior to closure with~     stitches in Port a Cath patients, who, as a population, are at increased risk for~     complications. All adult patients who present for initial Port a Cath placement during the~     recruitment period will be eligible to participate in the study. Subjects will be randomized~     to either skin incision closure with standard stitches or closure with skin glue. Time to~     complete skin closure and costs of closure will be compared. Patients will be evaluated~     approximately one month and three months from the procedure to assess for complications of~     wound breakdown or infection, as well as for the appearance of the Port a Cath incision.~   "
103475|NCT02212964|"~     Using a multi-echo gradient echo sequence to calculate R2* and quantitative susceptibility~     maps and well as susceptibility-weighted imaging post processing the investigators~     hypothesize that the investigators would be able to distinguish between pseudoprogression and~     true progression with the use of an easily implementable sequence on clinical MRI scanners.~   "
103476|NCT02212951|"~     The study is to compare meal time glucose control associated with BIOD-531, a rapidly~     absorbed concentrated insulin to that associated with Humalog Mix 75/25 and Humulin R U-500.~   "
103477|NCT02212938|"~     To investigate the relative bioavailability of BI 14332 CL vs. BI 14332 CL after intake of a~     standardised high fat breakfast~   "
103478|NCT02212925|"~     To investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 14332~     CL following administration of multiple rising oral doses over 10 days in patients with type~     2 diabetes.~   "
103479|NCT02212912|"~     The purpose of this study is to evaluate whether a multifaceted quality improvement~     intervention can improve the adherent rate of individual and composite of evidence-based~     performance measures for patients with acute ischemic stroke within the first 7 days of~     symptom onset and reduce the incidence of a new clinical vascular event, disability, and~     all-cause mortality at discharge and long term clinical outcome.~   "
103480|NCT02212899|"~     To establish an observational registry for systematic collection of clinical data from~     Renaissance-guided spine surgeries.~   "
103481|NCT02212886|"~     -  This is a phase IIa study in which GA Depot 80 or 40mg is administered as an IM~          injection to subjects with RRMS at 4 week intervals for 52 weeks of treatment.~        -  The purpose of the study is to assess safety, tolerability, and efficacy of a monthly~          long-acting IM injection of 80 or 40mg GA Depot in subjects with RRMS. The study will~          include subjects switching from daily or thrice weekly administration of 20 mg or 40mg~          respectively of glatiramer acetate (GA, i.e., Copaxone) injection~   "
103482|NCT02212873|"~     In order to address and curb the high prevalence of childhood obesity in Malaysia, a~     school-based intervention program, MyBFF@school is developed for implementation in all~     schools in the country. The program is specific for overweight and obese students and it is~     hypothesized that by participating in this program, students will be able to control their~     body mass index.~   "
103524|NCT02212314|"~     The investigators will conduct a pilot study investigating the effectiveness of a~     computerized response inhibition training program at reducing the response inhibition~     difficulties often seen in children with Williams syndrome ages 10-17. The investigators~     hypothesize that after completing the training program, children with Williams syndrome will~     show improvement on computerized measures of response inhibition and on parent measures of~     impulsivity.~   "
103483|NCT02212860|"~     Radiation therapy after surgery to remove breast cancer improves control of the breast~     cancer. Standard therapy after breast conservation surgery is five to six weeks of radiation~     to the entire breast.~      This clinical trial will evaluate the effectiveness of conformal radiation therapy delivered~     only to the area in the breast where the lumpectomy will be performed.~      This study will determine if radiation therapy delivered in this manner will prevent the~     cancer from coming back and eliminate the need for five to six weeks of radiation.~      The study will also gather information about the safety and effects (good and bad) this~     radiation has, and on patient satisfaction with the appearance of the breast.~   "
103484|NCT02212847|"~     Spatial orientation is achieved through central integration of various sensory inputs and~     prior knowledge in a statistically optimal way based on the reliability of the different~     signals. When upright, the subjective visual vertical (SVV) is accurate and precise in~     healthy human subjects. However, when roll-tilted, both systematic physiologic, roll-angle~     dependent errors (termed A- und E-effect) and a decrease in precision of SVV estimates have~     been described. In case of a sudden unilateral vestibular deficit (UVD) a significant~     imbalance between the two vestibular organs occurs at the level of the vestibular nuclei,~     disrupting the percept of vertical. The most frequent cause for such a unilateral vestibular~     deficit is an inflammation of the vestibular nerve by viral infection, termed vestibular~     neuritis (VN). While in the acute stage these patients are usually immobilized due to the~     severity of symptoms, recovery is overall good and most patients return to their daily~     activities within a few weeks. Central compensation is considered the most important~     contributor to recovery in these patients, while recovery of the damaged vestibular nerve~     occurs only in a minority of cases. While acute VN presents with sudden UVD, bilateral~     vestibular deficits (BVD) typically evolve more slowly and re-sult in distinct complaints.~      The percept of vertical can be quantified by assessing the subjective visual vertical or SVV,~     which is usually done by letting subjects adjust a luminous line along perceived direction of~     gravity. Modifications of this paradigm which are independent from retinal input are e.g.~     adjustments of a rod along perceived vertical in complete darkness (termed subjective haptic~     vertical or SHV) and self-alignments along perceived vertical (subjective postural vertical~     or SPV) and perceived horizontal (subjective postural horizontal or SPH) in complete~     darkness. Previous research has proposed no unified percept of vertical as errors assessed in~     different domains (visual, haptic, postural) were diverging in patients with acute UVD. While~     errors were profound for the SVV, the SPV remained accurate.~      Here the investigators aim to quantify verticality perception in patients with either acute~     or chronic UVD and patients with BVD both in upright and roll-tilted positions. Specifically,~     the investigators will use different paradigms to address the ques-tion whether there is a~     unified percept of vertical and how a bias in this percept changes over time.~   "
103485|NCT02212834|"~     The purpose of this study is to determine the effectiveness of surveillance breast MRI~     compared to mammography alone in women with a personal history of breast cancer~   "
103486|NCT02212821|"~     The purpose of this study is to investigate the role of erythromycin, a prokinetic agent, on~     hunger, and the brain mechanism lying behind it.~   "
103487|NCT02212808|"~     The Infectious Diseases Society of America (IDSA) guidelines recommend two core strategies~     for Antibiotic Stewardship (AS): 1) antimicrobial restriction and preauthorization and 2)~     prospective audit with intervention and feedback. Community hospitals have limited or no~     resources and staff dedicated to AS. Thus, understanding which of the core strategies is most~     feasible and effective in this practice setting would assist in appropriate allocation of~     limited resources. The purpose of this study is to evaluate the feasibility of implementing~     antimicrobial restriction and preauthorization vs. post antibiotic prescription review in~     resource-limited community hospitals.~   "
103488|NCT02212795|"~     Phase I clinical study to compare the pharmacokinetic profiles and bactericidal activity of~     Zabofloxacin 183mg, 367mg and Levofloxacin 250mg after oral administration in healthy~     volunteer~   "
103489|NCT02212782|"~     Phase I clinical study to evaluate DW1029M influence the pharmacokinetic profiles of~     Linagliptin after oral administration in healthy male volunteer.~   "
103490|NCT02212769|"~     Phase I clinical study to evaluate DW1029M influence the pharmacokinetic profiles of Losartan~     after oral administration in healthy male volunteer~   "
103491|NCT02212756|"~     Phase I clinical study to evaluate DW1029M influence the pharmacokinetic profiles of~     Metformin after oral administration in healthy male volunteer~   "
103492|NCT02212730|"~     This study will examine the effect of treatment with the neoadjuvant antibody pembrolizumab~     (MK-3475) on tumors of participants with renal cell cancer (RCC). The primary hypotheses are~     that pembrolizumab is well tolerated in participants undergoing RCC tumor resection; and that~     pembrolizumab will stimulate a 2-fold or greater increase in intratumoral lymphocytic~     infiltration in at least 30% of participants with RCC.~   "
103493|NCT02212717|"~     Acute cholecystitis commonly occurs in elderly patients that are high-risk candidates for~     surgery. Percutaneous cholecystostomy (PC) is frequently employed for gallbladder drainage in~     these patients. Recently, the feasibility of EUS-guided gallbladder drainage (EGBD) in~     treatment of this condition has been demonstrated but how the two procedures compare to one~     another is uncertain.~      The aim of this study is to compare EGBD versus PC as a definitive treatment, in high-risk~     patients suffering from acute cholecystitis in a randomized controlled trial. We hypothesize~     that EGBD can reduce the morbidity, re-intervention and mortality when compared to PC.~   "
103494|NCT02212704|"~     The purpose of this study is to evaluate the relative contribution of head- and trunk-based~     sensory systems to internal estimates of direction of gravity in healthy human subjects. To~     implement this assessment experimentally, the investigators will use a motor-driven~     3D-turntable and a thermoplastic mask to keep the head in a stable, either roll-tilted (±30°)~     or aligned with the trunk. The investigators will then obtain measurements of the subjective~     visual vertical in seven different whole-body roll positions (max. 90° roll-tilt). Analysis~     will be driven by a state-of-the art Bayesian integration model. The investigators~     hypothesize that different sensory input signals are combined in a statistically optimal~     fashion.~   "
103495|NCT02212691|"~     The purpose of this research is to use non-invasive imaging technologies to study how the~     human brain processes pain. The investigators will use contact heat to induce pain and record~     data scalp EEG and functional magnetic resonance imaging (fMRI). What the investigators learn~     from this study will help us gain insights in pain management with broad socioeconomic~     impacts~   "
103496|NCT02212678|"~     The investigators are interested in evaluating the use of oral N-acetylcysteine (NAC) as~     therapy for Parkinson's Disease (PD) and measuring changes in brain and blood chemistry.~   "
103497|NCT02212665|"~     The aim of the study 'Live - without diabetes' is to investigate the effects of increased~     physical activity on a daily basis with or without (high intense interval training) HIIT~     (short and intense: 3 minutes per week) during 12 weeks in risk individuals with pre-diabetes~   "
103525|NCT02212301|"~     This study is comparing two silicone hydrogel contact lenses in a controlled environment for~     identification of characteristics associated to vision.~   "
103498|NCT02212652|"~     VISTA is looking to see if vitamin D supplements before bariatric surgery might improve~     vitamin D stores, which may help to prevent some complications like infections.~      Who can join this research study?~        -  Approved to undergo bariatric surgery—Roux-en-Y Gastric Bypass or Vertical Sleeve~          Gastrectomy—at the Johns Hopkins Bayview Medical Center~        -  18 to 64 years of age~        -  BMI of 35 to 49.9 kg/m2~        -  VitD insufficient or deficient prior to having surgery~      What will happen if a participant chooses to participate in this research study?~        -  The participant will be randomly assigned (by chance) to receive either:~        -  Standard care plus vitamin D supplements or~        -  Standard care plus a placebo (contains no vitamin D)~        -  Either would be provided at no cost to the participant~        -  The investigators will ask the participant to complete a survey on the day of surgery~          regarding supplement use~        -  The investigators will follow the participants medical record through the 12 month~          follow up clinic visit.~   "
103499|NCT02212639|"~     Classic and endemic Kaposi's sarcoma (KS) are lymph angio proliferations associated with~     human herpes virus 8 (HHV8) which treatment is poorly codified. Chemotherapies give at best~     30-60% of transient responses. While interferon responses are frequent, this drug is often~     poorly tolerated in elderly patients. Therefore new therapies are needed. Classic KS~     represents an ideal model for evaluating new drugs since patients do not receive concomitant~     immunosuppressive regimens nor antiviral therapies.~      Hypoxia-inducible factor 1(HIF-1 alpha) is a major regulator of solid tumor growth and~     therefore a suitable target currently explored in many cancers. Moreover HIF-1 alpha enhances~     HHV-8 gene expression in KS and induces lytic replication cycle. Digoxin has anti cancer~     effect in vivo through HIF-alpha down regulation in several preclinical tumor models~     including KS. The identification of HIF-1 alpha as a key factor in HHV8 replication prompt us~     to explore inhibition of HIF-1 alpha by digoxin as a potential therapeutic approach for KS~     treatment it has and consequently may down regulate HHV-8 replication in KS. This latter~     approach is heightened by recent data suggesting that Digoxin has some efficacy in vitro~     against others human herpes virus i.e. Herpes simplex and Cytomegalovirus (8) (9)~      In this study the investigators shall evaluate the benefit and safety profile of digoxin in~     classic and endemic KS (serum drug concentration of 0.6 to 1.2 ng/ml for patients <75 years~     and between 0.5-0.8 ng/ml in patients older than 75 years The participants will take study~     drug digoxin, for a total of 6 cycles (4 weeks/cycle).~   "
103500|NCT02212626|"~     The objective of this study is to evaluate the safety and efficacy of recanalization of acute~     and subacute femoropopliteal stent occlusions with the Rotarex S catheter (Straub Medical)~   "
103501|NCT02212613|"~     The purpose of this study is to explore the effects of fixed-dosed brexpiprazole adjunctive~     treatment in subjects with Major Depressive Disorder with irritability~   "
103502|NCT02212600|"~     The proposed project will be a multi-centre, prospective observational study to determine the~     prognosis and determinants of functional outcomes of patients with proximal humerus~     fractures. Approximately 10 centres will participate in this observational cohort, each~     enrolling at least 50 patients over the course of 2 years.~   "
103503|NCT02212587|"~     The objective of this study is to determine if tobramycin inhalation powder (TIP) can reduce~     the amount of Burkholderia Cepacia Complex (BCC) species - type of bacteria, in the sputum of~     cystic fibrosis patient.~   "
103504|NCT02212574|"~     Participants enrolling on this study will receive standard of care chemotherapy for Wnt~     positive medulloblastoma without the radiation therapy or the weekly chemotherapy that is~     given during radiation therapy.~   "
103505|NCT02212561|"~     The purpose of this study is to test the safety of selinexor (KPT-330) and to find the~     highest dose of selinexor (KPT-330) that can be given safely when it is combined with two~     chemotherapy drugs (fludarabine and cytarabine). This study will be done in two parts: Phase~     I and Phase II.~      The goal of Phase I is to find the highest tolerable dose of selinexor (KPT-330) that we can~     give to patients with leukemia or MDS, when it is combined with fludarabine and cytarabine.~      The goal of the subsequent Phase II portion of the study (insert NCT ID of SELHEM-2) is to~     give the highest dose of selinexor (KPT-330) in combination with fludarabine/cytarabine that~     was found in Phase I to be safe for children with leukemia or MDS. The investigators will~     examine the effect of this combination treatment.~      PRIMARY OBJECTIVE:~        -  Determine a tolerable combination of selinexor, fludarabine, and cytarabine in pediatric~          patients with relapsed or refractory hematologic malignancies included acute myeloid~          leukemia (AML), acute lymphoblastic leukemia (ALL), mixed phenotype acute leukemia~          (MPAL) and myelodysplastic syndrome (MDS).~      SECONDARY OBJECTIVES:~        -  To characterize the pharmacokinetics of selinexor, when administered in tablet form,~          after the first dose and at steady-state, as well as in combination with fludarabine and~          cytarabine~        -  To estimate the overall response rate of selinexor given with fludarabine and cytarabine~          in patients with relapsed or refractory hematologic malignancies~   "
103506|NCT02212548|"~     This is a Phase I prospective study of 30 patients to determine whether PEG hydrogel~     (SpaceOAR) reduces the dose of radiation delivered to the rectum during Image Guided~     Intensity Modulated Radiotherapy (IG-IMRT) for prostate cancer, by increasing the space~     between the prostate and the rectum.~   "
103507|NCT02212535|"~     The purpose of this study is to assess the tolerance and efficacy of mobilizing hematopoietic~     stem cells after a single injection of plerixafor (0.24mg/kg) in 3 adult patients (or 5, if~     results of the first 3 patients are not reproducible) affected by sickle cell disease.~   "
103526|NCT02212288|"~     To date, oxidative stress in PKU has been evaluated only with fragmented approaches.The aim~     of the present study is to investigate oxidative stress in PKU with more comprehensive~     methods.The relationship between oxidative stress and metabolic disturbances~     (hyperPhenylalaninemia) will also be studied.~   "
103527|NCT02212275|"~     The investigators overarching aim is to obtain preliminary data to support a larger grant to~     validate a novel objective, physiologically-based outcome measure for clinical trials in~     autism spectrum disorders (ASDs) called the cortical metric. Absence of such an outcome~     measure has greatly hindered the development of treatments for core symptoms of ASD.~   "
103719|NCT02209753|"~     The clinical objective of this study was to determine the effect of BIRB 796 BS on~     pharmacodynamic markers of psoriasis as a measure of efficacy, to determine the population~     pharmacokinetics of BIRB 796 BS and to determine the safety of BIRB 796 BS over 4 weeks of~     treatment in patients with moderate to severe plaque-type psoriasis.~   "
103508|NCT02212522|"~     The aim of this study is to complete the identification of genetic factors (G) and to~     undertake the search of environmental factors (E) predisposing to type 1 diabetes (T1D) by~     constituting a cohort of 3500 T1D patients and a control cohort. We will use the base of G~     analysis (whole genome genotyping done once a patient using methods conually updated at~     Centre National de Genotype) and innovative E analysis to develop the following long term~     objectives :~        -  Identify G and E factors influencing the process of remaining beta cells' destruction~          during the first 3 years after diagnosis (subgroup of T1D patients with a 0-3 years~          diabetes duration);~        -  Identify G factors (pharmacogenomics) of the individual response to insulin using the~          effective insulin dose as a phenotype over a period of 2 years (subgroup of T1D patients~          with negative C-peptide and well managed diabetes);~        -  Undertake a prospective research of G and E risk factors of death in bed syndrome in~          diabetic adolescents;~        -  Undertake a prospective research of G and E risk factors of incipient glomerular~          microangiopathy (regule measurement of microalbuminuria).~   "
103509|NCT02212509|"~     The aims of the cohort study is to describe the rates of 30-day surgical complication,~     functional decline, frailty and one-year mortality for patients experienced cardiac surgery~     and to delineate the trajectory of functional capacity 1 year after surgery for the patients.~     It also will test whether the trajectory of functional varied significantly according to~     delirium status and its type over the follow-up period and examine the patients' postsurgical~     actual caloric/protein/fluid intake in relation to the functional capacity within 3 months~     after surgery as well as evaluate whether activity levels, dietary diversity, and depressive~     symptoms at 3,6, and 12 months affect patient outcome.~   "
103510|NCT02212496|"~     Although there has been increasing interest in the association between cancer and~     cerebrovascular disease, the underlying pathophysiology of stroke in cancer patients is still~     not fully understood. The aim of this study is to investigate the stroke mechanisms in~     patients with cancer-associated stroke.~   "
103511|NCT02212483|"~     Asthma is one of the most prevalent chronic respiratory diseases, with potential~     lifethreatening impacts. Indeed, asthma is still responsible for about a thousand deceases~     per year in France, and constitutes a public health problem in our country as in many~     countries in the world. The economic burden of asthma is also very high, in terms of health~     care, and indirect costs including lost work and lost school days.~      A few international and French studies have shown a positive clinical impact of Medical~     Indoor Environment Counselors (MIECs) visiting homes of asthma patients, mainly pediatrics.~     It has been proposed that MIECs could contribute to reduce patient exposure to many allergens~     and irritants, among them, house dust mite allergens, formaldehyde or molds. Most of the~     studies that show a significant decrease of hospitalization or visit in an emergency ward for~     asthma are monocentric and study the eviction of 1 such identified risk factor. By contrast,~     meta-analysis underline that additional studies are needed to evaluate the effectiveness of~     these interventions in adults, in a multicentric and controlled manner, with both clinical,~     environmental and economical endpoints.~   "
103512|NCT02212470|"~     The purpose of this study is to evaluate whether the results of drug eluting balloon are~     equivalent to the Nitinol stent implantation in the Superficial Femoral Artery.~   "
103513|NCT02212457|"~     The main purposes for conducting the study are firstly to assess immunological~     non-inferiority of the MenABCWY vaccine, administered according to 0, 2 month schedule to~     healthy adolescents 10 to 18 years of age, to those of the licensed rMenB+OMV vaccine~     (Bexsero™) in terms of hSBA GMTs at one month after the second vaccination, secondly to give~     the flexibility for the national vaccination program by showing the safety and immunogenicity~     of MenABCWY administrated according to four different vaccination schedules and additionally~     to evaluate a potential benefit of the 3-dose vaccination series.~   "
103514|NCT02212444|"~     Plantar fasciitis (severe pain in the heel) is a common problem that has a significant impact~     on quality of life. There is some evidence to support the use of orthoses and stretches in~     the conservative management of plantar fasciitis but current orthotic management may not be~     optimal. More prolonged stretching with night splints may achieve better results but such~     splints are clinically not well tolerated. Therefore, there is a potential need to apply~     prolonged stretching during the day and during dynamic tasks such as walking. This has led to~     the development of other rigid and semi-rigid splints that have shown promising results in~     small scale clinical trials. There are disadvantages however with the more rigid bracing and~     orthoses seen in these types of splints. For example, they are often difficult to accommodate~     with a person's available shoes; this can be particularly difficult for women and thus limits~     their compliance with the intervention. Further, more rigid bracing can be uncomfortable~     during fast walking and running and so limits participation in such activities.~      Recently a novel orthotic, a customised dynamic elastomeric fabric orthoses (DEFO), has been~     developed. Being made from lycra® based materials the sock-like splint is lightweight and~     discrete, allowing it to be accommodated easily into most shoe types and potentially better~     tolerated when worn at night compared to currently available splints. Its design further~     allows it to be used comfortably during dynamic tasks such as walking and running as~     supported by initial anecdotal evidence in athletes. To date there has been no evaluation~     into the effectiveness of the DEFO in the general population with plantar fasciitis.~      This study will look at the feasibility of conducting a randomised controlled trial into the~     use of a DEFO compared to an off-the-shelf orthoses as an adjunct to usual care.~   "
103515|NCT02212431|"~     The morbidity and mortality associated with Cystic Fibrosis (CF) are the result of chronic~     suppurative lung disease. The aggressive use of antibiotics is one of the mainstays of~     treatment in CF, however, the problems of multiple drug resistance and adverse reactions are~     major clinical issues.~      Cysteamine is a licensed drug used in the treatment of cystinosis. In vitro work suggests~     that cysteamine has properties of potential benefit in CF. Cysteamine is a potent mucolytic,~     it disrupts biofilms, it is antimicrobial, and synergises with other antibiotic agents. CF is~     characterised by malabsorption and it is not known whether cysteamine is absorbed in CF,~     furthermore it is not known if cysteamine enters the bronchial secretions. It is not possible~     to assume that the pharmacokinetics of cysteamine in patients with CF are the same as those~     reported for cystinosis.~      Objectives: to characterise the pharmacokinetic profile of cysteamine in people with CF, to~     ascertain whether cysteamine enters the bronchial secretions and the tolerability of~     cysteamine by patients with CF.~      Method: a single centre, single group open label investigation of the tolerability and~     pharmacokinetics of oral cysteamine (Cystagon) when administered to patients with Cystic~     Fibrosis at the dose licensed for use in cystinosis.~      Setting: adult CF clinic, Aberdeen Royal Infirmary.~      Target population: 12 patients aged ≥18years with CF associated lung disease who are~     clinically stable.~      Intervention: Oral cysteamine (Cystagon) will be increased from 450mg od to 450mg qds over~     three weeks, they will remain on 450mg qds for two weeks.~      Assessment: face to face health outcome assessments will be carried out for all participants~     at recruitment/baseline, 1, 2, 3, and 5 and 6 weeks. Serial blood cysteamine levels will be~     measured in the first 24 hours after the first dose. Sputum cysteamine will be quantified~     after two weeks of full dose cysteamine 450mg qds. Disease specific health status (CFQ-R)~     will be assessed at baseline and after two weeks of full dose. At each assessment, lung~     function (FEV1, FVC), adverse reactions and serious adverse events will be ascertained. Blood~     samples will be taken for measurement of haematological and biochemical parameters. Sputum~     samples at each assessment will be analysed for microbial load and spinnbarkeit.~   "
103723|NCT02209701|"~     Study to determine the steady-state pharmacokinetics and urinary excretion of porfiromycin~     and major metabolites in head and neck cancer and other cancer patients with solid tumors who~     receive radiation therapy.~   "
103516|NCT02212418|"~     Abdominal hypopressive technique (AHT) is a therapy created for the treatment of the pelvic~     floor dysfunctions in the postpartum. In the last years it has been extended out of such~     medical context but there is a lack of scientific evidence, and the endurability of the~     effects of this technique are unknown. The investigator´s aim was to evaluate the effect of a~     12 weeks AHT program on 1) the tone of the pelvic floor muscles and 2) on urinary~     incontinence, in women out of the postpartum phase. In addition the investigators looked for~     the endurability of its effect.~      Methods: The investigators performed a cross-over blinded intervention study of 4 month~     duration, in which women, stratified by age, were randomly assigned to a sequence of AHT-no~     AHT or no AHT-AHT. The AHT program consisted of 30 minute sessions, 3 days per week during 2~     months. The investigators compared the effect of AHT versus no AHT, and of no AHT after 2~     months versus AHT.~      The endpoints were the differences in perineal tonometry, and urinary incontinence symptoms,~     as measured by the ICIQ_SF. Comparisons were tested with student t tests, paired or unpaired~     as adequate.~   "
103517|NCT02212405|"~     Findings from this study may demonstrate how the insula contributes to reward pathways~     involved in addiction. There are three main hypotheses for this trial. The first is that~     inhibiting the insula using transcranial magnetic stimulation (TMS) will not cause noticeable~     changes of dopamine release in the striatum. The second is that stimulating the insula with~     TMS will increase dopamine release in the striatum, and will be visualized on PET imaging as~     decreased radiotracer binding. The third hypothesis is that the participants will not~     experience major side effects from TMS on the insula.~   "
103518|NCT02212392|"~     The use of prophylactic antibiotics is beneficial in reducing the extrapancreatic infections~     and shorter hospital stay in patients of acute pancreatitis as compared to controls.~   "
103519|NCT02212379|"~     This multicenter, international, non randomized (single arm), open, phase II trial aims to~     evaluate the capacity of the dual combination raltegravir/etravirine to maintain virological~     success in virologically suppressed HIV-1 infected patients, of at least 45 years of age,~     switching from a boosted PI-containing regimen. Patients will be followed for 96 weeks.~     Measurement of primary endpoint will be at 48 weeks. Virological success is defined as the~     absence of 2 consecutive plasma viral load >50 copies/mL within 2 to 4 weeks of a dual~     raltegravir/etravirin regimen. Raltegravir/etravirine will be considered acceptable if the~     percentage of patients in virological success at week 48 is significantly above 90 %.~     Assuming a 95 % virological success rate, by including 160 individuals and considering the~     strategy to be acceptable if no more than 8 individuals have virological failure;~     investigators will have a 95 % probability to discard a combination for which efficacy is~     smaller than 90 % and investigators will select with a power of 80 % the strategy for which~     the efficacy is above or equal to 95 %. The principal secondary endpoint is the proportion of~     patients in therapeutic success up to week 48 and 96.~   "
103520|NCT02212366|"~     Late Life Depression (LLD) is a serious health problem which not only causes depressed mood~     but also results in impairments in memory and attention. These impairments are likely to be~     resistant to treatment, which increases the chances of developing dementia even after~     successful treatment of mood.This study is a randomized controlled trial of transcranial~     Direct Current Stimulation (tDCS) in people with LLD to enhance their cognition after~     successful treatment of mood with established medications. tDCS is non invasive, relatively~     inexpensive and portable, and has been found to be safe.This study also serves as a pilot~     study to assess the effects of tDCS on cognition and neurophysiologic markers of cognition~     among patients with LLD. Primary study hypothesis is that participants Participants~     randomized to tDCS will perform better on a working memory task 2 weeks and 3 months~     following the tDCS course.~   "
103521|NCT02212353|"~     This small observational study is a contractual component of a 5-year (2013-18) NIHR funded~     programme called PERFECTED (Peri-operative Enhanced Recovery hip FracturE Care of paTiEnts~     with Dementia) whose overall aim is to develop and pilot an evidence-based intervention to~     improve the hospital care of patients with dementia suffering a fractured hip. The findings~     from this particular observational study will support other PERFECTED work-packages in~     establishing current care practices in acute hospital settings for older people in general~     with hip fractures.~      Observation is a well-established qualitative technique widely used to understand cultures,~     processes and interactions in defined locations including hospitals. In this study,~     researchers will observe day-to-day practices on specific ortho-geriatric wards and Emergency~     Departments in three English hospitals (Norfolk and Norwich University Hospital, Bradford~     Royal Infirmary and Queen's Medical Centre in Nottingham). Observations will occur~     intermittently over a 4-week period, covering the full 24h cycle. The prime objective of the~     study is to describe delivery of care to older patients with a hip fracture including an~     assessment of cost consequences. Crucially, the observations will focus exclusively upon the~     hospital personnel that routinely provide care in the designated locations being observed.~     Other individuals who frequent the locations (patients, visitors and other more peripheral~     health care professionals) are NOT the focus of the research and will be regarded as~     incidental others rather than participants. This approach is common in observational~     research.~      Observations will be conducted by experienced qualitative researchers and assisted by~     specifically trained lay researchers to provide a valuable service-user dimension to the~     study. Field-notes and contextual information will be collected and thematically analysed,~     again in partnership with trained 'lay' researchers. Resulting data will address the~     pre-defined aims of the observational study and feed into the findings reported across the~     whole of work package 1 of PERFECTED.~   "
103522|NCT02212340|"~     Total intravenous anesthesia (TIVA) and inhalation anesthesia are both widely and safely~     used, and there are many clinical trials comparing these on various aspects of anesthesia.~     However, there have not been studies comparing the quality of recovery from the different~     methods of general anesthesia in vitrectomy. In this study, the investigators compare the~     functional recovery after general anesthesia in TIVA and inhalation anesthesia with QoR-40~     questionnaire in vitrectomy.~   "
103523|NCT02212327|"~     The investigators' overarching goal is to improve long-term outcomes for end stage renal~     disease (ESRD) patients. In this study we focus specifically on patients receiving peritoneal~     dialysis (PD). Volume regulation in PD patients is related to hypertension, heart failure,~     nutritional status, and survival. Salt (NaCl) is the body's ion transport target to normally~     regulate volume via the kidneys; however, in hemodialysis (HD) patients the dialyser or in PD~     patients the peritoneal membrane, must serve that purpose. Determining volume status in PD~     patients is not easy and monitoring sodium (Na+) is more difficult still. The investigators~     have developed a novel, noninvasive approach to this problem involving 23Na+ magnetic~     resonance imaging (Na-MRI). Na+ is stored bound to proteoglycans in mostly the skin. Our~     technique measures Na+ in skin and skeletal muscle. In this study, we propose to apply this~     novel technique to PD patients.~      Aim 1. To determine Na+ stores in PD patients, to compare Na+ stores to normal controls using~     Na-MRI technique, and to correlate Na+ stores by Na-MRI with multifrequency bioimpedance~     measurements and cross-sectional clinical data.~      Hypothesis: Na+ stores are increased in PD patients compared to normal controls; they are~     increased in PD patients with volume expansion and in those patients with high soluble~     vascular endothelial growth factor receptor-3 (sFlt-4) levels.~      Aim 2. To determine the utility of Na-MRI as an assessment of preserving residual renal~     function in PD patients.~      Hypothesis: Extracellular volume expansion as measured by multifrequency bioimpedance was~     found to have no utility in predicting preservation of residual renal function in PD~     patients. The investigators hypothesize that Na+ stores as determined by 23Na-MRI will~     fulfill that function and will be inversely, rather than directly, related.~   "
103528|NCT02212262|"~     Progress in the treatment of myeloma and myeloma bone disease has substantially increased~     overall survival, but relapse is inevitable and better treatment is needed. The bone~     microenvironment is tremendously complex, so that targeting single interactions between tumor~     and bone is unlikely to be effective. Treatments need to block centrally important,~     multifunctional pathways. The investigators data point to a central role of the osteocyte to~     induce heparanase, a multifunctional mediator of myeloma bone disease. Increased heparanase~     due to FGF23 may make systemic inhibitors of heparanase less effective in bone than~     elsewhere. FGF23 neutralizing antibodies have been developed for non-cancer conditions of~     FGF23 excess, such as chronic kidney disease (Shimada & Fukamoto, 2012), and could be used in~     MM alone or in combination with heparanase inhibitors. Complete neutralization of FGF23 has~     adverse effects, but neutralization of FGF23 excess may be practical, or in the future,~     suppression of excess FGF23 biosynthesis by osteocytes.~      The investigators hope to determine serum FGF23 and heparanase, Dkk1 and plasma klotho levels~     in patients with newly diagnosed and relapsed myeloma compared to healthy controls with this~     exploratory study.~   "
103529|NCT02212249|"~     Ve-cadherin is expressed in endothelial cells. Systemic slerosis is a rare auto-immune~     disease with a endothelial dysfunction. This study is to evaluated the level of soluble~     VE-cadherin and VE-cadherin antibody in patients with systemic slerosis.~   "
103530|NCT02212236|"~     This Phase II trial aims to evaluate a new psychological intervention to alleviate distress~     during haematopoietic stem cell transplantation (HSCT) together with examining feasibility.~      HSCT is a complex procedure aimed at a range of haematological and autoimmune illnesses. Over~     3,000 individuals undergo the procedure every year in the UK with substantial benefits.~     However, it is very costly, intensive, and has a range of debilitating side effects.~     Consequently, patients often experience considerable distress, which can impede recovery.~      A 90-minute, group-based intervention has been developed to address this need based on~     psychological theory of adjustment to illness-related difficulties. It is delivered by the~     transplant team and involves provision of information to foster more helpful perceptions~     about HSCT and facilitating more helpful coping with its difficulties. To evaluate the~     effectiveness of the intervention in alleviating distress, 60 patients about to undergo HSCT~     at two sites (Sheffield & Nottingham) will be randomly allocated into two groups. Patients in~     the intervention group will receive the new intervention prior to transplantation together~     with treatment as usual (TAU) while patients in the control group will receive TAU alone.~     Participants and the researcher collecting the data will be blind to the allocation.~      Demographic and relevant clinical information will be recorded at the end of participation to~     ensure effectiveness of randomisation. For both groups, resilience, distress, coping, and~     procedure-related perceptions will be measured at four time points: (i) prior to the~     intervention/transplantation, (ii) day of transplant, (iii) two weeks following the~     transplant, and (iv) four weeks following the transplant. It is hypothesised that patients in~     the intervention group will experience higher resilience and lower distress compared to~     controls and that this difference will be mediated by procedure-related perceptions and~     coping. A subgroup of participants of those randomised to the group intervention will be~     invited to participate in a feedback interview at the end.~   "
103531|NCT02212223|"~     Insufficient intake of vitamin D is a public health problem, affecting about 40% of the~     Finnish population in the winter. Vitamin D has a wide range of health effects: in addition~     to its effect on bone, it is known to affect inflammatory response among other things. The~     sources of vitamin D are the synthesis in the skin as well as diet and dietary supplements.~     In Finland and in Northern Europe vitamin D is formed in the skin only from March to October.~     This alone is not sufficient to cover the need for year-round, because vitamin D storage is~     used in a few months. During the winter months the only sources of vitamin D are diet and~     vitamin preparations. Current vitamin D recommendations are usually based on studies in white~     population. However, there can be a difference in the need of vitamin D and in vitamin D~     metabolism between different population groups. More research evidence is needed from the~     northern countries. The aim of this study is to evaluate the vitamin D need in Somali~     immigrant population and in original Finnish population. The hypothesis is that the Somalis~     need more vitamin D to exceed the serum 25(OH)D concentration of 50 nmol/L than the original~     Finnish population.~   "
103532|NCT02212210|"~     The purpose of this study is to look to see if adding steroids to an epidural reduces the~     chances of having a fever in labor, and protects the baby from exposure to inflammation.~   "
103533|NCT02212197|"~     The purpose of this study is to assess the pharmacokinetics, pharmacodynamics, efficacy and~     safety of CAM2032 versus Eligard, in patients with prostate cancer. All patients will receive~     leuprolide acetate administered subcutaneously once monthly during 3 months.~   "
103534|NCT02212184|"~     The aims of this study are to evaluate the effects of Diaphragm Release Manual Technique on~     diaphragm mobility, chest wall kinematics and functional capacity of COPD patients. Methods:~     Randomized controlled trial (double blinded) with COPD patients, allocated in two group:~     intervention (IG) who will receive the Diaphragm Release manual technique on 6~     non-consecutive sessions and control group (CG), who will receive a sham protocol (light~     touch) with the same parameters of IG. Outcomes will be evaluated as: immediate and post~     treatment effects (after 1 and 6 sessions respectively). The primary outcome analysed will be~     the diaphragm displacement (ultrasonography evaluation) and secondary outcomes will comprise~     abdominal and chest wall kinematics.~   "
103535|NCT02212171|"~     Background: With new challenges for healthcare, there is a clear consensus among experts on~     the need to introduce changes in the organization of care in health centres to address the~     problems of over-attendance, bureaucratization and other emerging issues that require growing~     amounts of attention. However, there has been insufficient research into possible models and~     the impact of their adoption.~      The objective is to assess the feasibility and effectiveness of the TRIAP intervention, a new~     organizational model based on triage and healthcare mini-teams (two general~     practitioners/pediatricians, two nurses and one member of the administrative staff) compared~     to the current model, aiming to achieve a correct classification of the healthcare needs of~     the primary care population and direct them to the most suitable professional.~      In addition, the implementation research objective is to identify the facilitators for and~     barriers to the implementation of the intervention in the context of primary care.~      Methods/ design: This is a quasi-experimental controlled clinical trial to be performed in 14~     healthcare mini-teams (7 intervention and 7 control groups) from 8 health centres in the~     Basque Healthcare Service (Osakidetza) Interior Health Region.~      The results will be assessed using the data on morbidity-adjusted attendance of users to~     their family doctor, number of referral, addition of new activities to the portfolio of~     services, and patient perception and professional satisfaction. All the variables will be~     measured at baseline and at the end of the intervention, 24 months later.~      Using covariance analysis models, the investigators will estimate the effect attributable to~     the intervention by analyzing differences in changes between the two groups, and calculating~     the 95% confidence interval, adjusting the comparisons for baseline values. The investigators~     will also adjust for potential confounding and effect-modifying variables.~      Nominal groups will be held at the end of the intervention with the participation of all the~     agents involved in intervention centres to identify the facilitators for and barriers to the~     implementation of the intervention.~      Discussion: There is a need to develop new forms of organization in primary care services to~     respond to new healthcare demands. To pursue this aim, changes have to be introduced in the~     organization of healthcare within health centres, redefining the roles of primary care~     professionals and refocusing their activity towards population health needs, seeking greater~     efficiency in health services.~   "
103724|NCT02209688|"~     The objective of this study was to obtain safety and tolerability data and first~     pharmacokinetic and pharmacodynamic data of escalating doses of ESR 1150 CL.~   "
109145|NCT02138812|"~     Determine the safety, tolerability, maximum tolerated dose (MTD), and recommended Phase II~     dose (RP2D) of BAY1161909 in combination with paclitaxel in subjects with advanced~     malignancies.~   "
103536|NCT02212158|"~     The purpose of this project is to assess the feasibility and efficacy of a new group therapy~     program for adolescents with Type 1 diabetes and compromised metabolic control (high A1c).~     This intervention is aimed at addressing issues frequently found to be associated with poor~     control: knowledge deficits, parental supervision, parent-teen communication and psychosocial~     barriers. In order to test this new group therapy program, adolescents' HA1c and psychosocial~     functioning will be monitored pre- and post-intervention. It is hypothesized that individuals~     who participate in the group therapy program will show an improvement in their HA1c levels~     and quality of life, self-efficacy, supportive behaviors from family members, readiness to~     make improvements in their diabetes care and decrease symptoms of depression.~   "
103537|NCT02212145|"~     To evaluate long-term effects of one individual- and population-oriented cardiovascular~     prevention programs in primary care.~   "
103538|NCT02212132|"~     This pilot study is, in this new and original approach in cancer pathology, measure and~     explain the correspondence between perceived cognitive impairment (cognitive complaint) by~     cancer patients and their cognitive scores goals with tasks metamemory while controlling the~     anxiety and depression and fatigue factors of patients.~   "
103539|NCT02212119|"~     Aim of the study is to perform a pilot study to assess the impact of Botulinum toxin on~     muscle tone, and caregiver burden in individuals who are cognitively impaired and who are~     fully dependent.~      The primary objective is to confirm proof of principle that paratonic rigidity and the~     consequences associated with it can be reduced with injection of Botulinum toxin injections~     resulting in reduced care-giver burden.~      The secondary objectives are to determine optimal time points for evaluation of efficacy in~     this patient population and whether the time period is sufficient for washout of Botulinum~     toxin effect; determine most salient and sensitive outcome measures; identify obstacles in~     data gathering; and lastly, to determine feasibility of battery of assessments in this pilot~     study.~   "
103540|NCT02212106|"~     This is a study to assess the safety of a bioCSL split virion, inactivated Trivalent~     Influenza Virus vaccine containing the 2014/2015 Northern Hemisphere strains of vaccine in~     children aged 5 years to less than 9 years. Comparison will be made to a licensed~     Quadrivalent Influenza Virus vaccine that complies with the FDA recommendations for the~     2014/2015 influenza season in the US.~   "
103541|NCT02212093|"~     Severe pneumonia has a high in-hospital mortality. There are few studies which investigate~     the long-term mortality in patients that are discharged alive from the hospital. In this~     study we want to investigate the 5 years mortality after treatment of severe pneumonia in an~     ICU. We will also investigate the cause of death after discharge from the hospital.~   "
103542|NCT02212080|"~     This study is a first in human study that will investigate the safety, tolerability and~     pharmacokinetics of ascending single doses of BAY1214784 using a placebo controlled,~     randomized, single center design. In addition the bioavailability of two different liquid~     formulations will be compared.~   "
103543|NCT02212067|"~     This trial is conducted in Europe. The aim of the trial is to investigate the effects of~     semaglutide on ß-cell function in subjects with type 2 diabetes.~   "
103544|NCT02212054|"~     The present study was designed to compare the efficacy of conservative treatment to operative~     treatment for improvement of constipation symptoms in children with Hirschsprung allied~     disease~   "
103545|NCT02212041|"~     People with mental illness are more likely to smoke and are more severely addicted to~     nicotine than the general population. As a result, the number of deaths related to tobacco is~     higher.~      Smoking is highly addictive because it delivers nicotine very quickly. Research studies show~     that people who use nicotine replacement therapies (such us patches, gums, etc) are more~     likely to quit smoking than those who try to quit without using these nicotine products.~     Recently a new electronic nicotine delivery system (ENDS), also known as electronic cigarette~     (e-cigarette) is rapidly gaining popularity. Electronic cigarettes are devices that mimic~     traditional cigarettes and deliver nicotine but do not carry the dangerous chemicals~     contained in tobacco cigarettes.~      Given the increasing popularity of e-cigs, there is an urgent need to improve our~     understanding of both the potential benefits and risks of e-cigs use in people with serious~     mental illness. In this pilot we propose inviting 50 people with schizophrenia (or~     schizophrenia-related disorder) who are not intending to quit smoking in the near future to~     take part in a study in which we will provide 6-weeks of free e-cigs, followed by a 4-week~     period in which they will not receive free e-cigs and we monitor which products participants~     choose, and a final 24-week follow-up visit. During the 24-week study period we will assess~     the use of e-cigs and tobacco cigarettes, the exposure to nicotine and tobacco toxicants,~     nicotine withdrawal symptoms, the changes in respiratory symptoms and psychiatric symptoms as~     well as the e-cigs perceived benefits and risks.~   "
103546|NCT02212028|"~     Prasugrel has shown to be superior to clopidogrel, in adjunct to aspirin, in preventing~     recurrent ischemic events. Prasugrel is approved in patients with ST-elevation myocardial~     infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) at a dosage of~     60 mg loading dose (LD) followed by 10 mg/day. However, a delay in the onset of its~     antiplatelet effects in this particular setting has been consistently shown. administration~     of clopidogrel and ticagrelor crushed tablets has been tested and a faster and greater~     bioavailability compared to the whole tablets has been observed. However, if the~     administration of a crushed prasugrel LD may overcome the above limitation is still unknown~     and represents the aim of our study. The proposed investigation will have a prospective,~     randomized, design in which STEMI patients undergoing primary PCI will be randomized to~     receive two different formulation of prasugrel LD (60 mg whole tablets and 60 mg crushed~     tablets). Pharmacodynamic testing will be performed at several time points to test our study~     hypothesis that crushed LD regiment will achieve more prompt and enhanced platelet inhibitory~     effects.~   "
103547|NCT02212015|"~     Open-label phase II trial investigating the efficacy and safety of the investigational~     combination of pazopanib and paclitaxel.~   "
103571|NCT02211703|"~     Study Objective:~        -  to project the incidence of perioperative hypothermia in patients with elective surgery~          under general anesthesia in China~        -  to determine the risk factors associated with perioperative hypothermia.~        -  to explore the patient outcome of hypothermia such as cardiovascular events, wound~          infection,hospital stay and so on.~      Study Design: The present study is a cross-sectional study with 30-day follow-up period.~   "
103548|NCT02212002|"~     The colonization of the neonatal gastro-intestinal (GI) tract begins at birth and is~     influenced by several factors, such as mode of delivery, gestational age, maternal intestinal~     and vaginal microbiota, type of feeding, hospitalization after birth and use of antibiotics~     and probiotics.~      Gut microbiota of term infants, vaginally delivered and exclusively breastfed, shows a low~     count of C. difficile and E. coli and a high number of Bifidobacteria and Lactobacilli, which~     positively influence the host's immunity processes; hence, is considered to be ideally~     healthy.~      Group B Streptococcus (GBS) represents one of the most important causes of neonatal~     infections and sepsis. Infants vaginally delivered may acquire GBS during the birth process~     from maternal vagina, cervix or rectum, where it resides in 10-20% of pregnant women. In the~     last decade, the incidence of early-onset GBS sepsis is significantly reduced, due to the~     introduction of GBS universal screening during late pregnancy and consequent intrapartum~     antibiotic prophylaxis (IAP) in GBS-positive women.~      The use of antibiotics in early life is shown to alter the commensal gut microbiota, thereby~     impairing the balance between health and disease later in life. The effect of IAP on~     bacterial colonization of the infant's gut, however, has not been largely investigated. The~     investigators have previously evaluated the effect of IAP in a relatively small sample of~     exclusively breast-fed term infants vaginally delivered by means of molecular techniques; at~     7 days of life there were several differences in microbiota composition between infants~     IAP-exposed and not exposed.~      This observational prospective study thus aims to evaluate these differences in further~     detail, expanding the initial sample to formula-fed term infants and following up infants~     until one month of age. By including formula-fed infants, the investigators additionally aim~     to evaluate the influence of feeding type on the neonatal microbiota composition.~   "
103549|NCT02211989|"~     To investigate safety, tolerability and pharmacokinetics, and pharmacodynamics of BI 14332 CL~   "
103550|NCT02211976|"~     Pilot study to evaluate the efficacy and tolerability of the combined treatment of bisacodyl~     and simeticone compared with the efficacy and tolerability of the single products in patients~     suffering from constipation and bloatedness~   "
103551|NCT02211963|"~     Study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI~     44847 following administration of multiple rising oral doses over 8 days in patients with~     type 2 diabetes.~   "
103552|NCT02211950|"~     The objectives were to investigate the relative bioavailability of BI 44847 in different~     racial groups (white, Asian, and African subjects) and to investigate the effect of different~     types of diet and acarbose coadministration on the bioavailability of BI 44847 in white~     subjects.~   "
103553|NCT02211937|"~     Study to investigate the relative oral bioavailability of 400 mg BI 44847 as suspension vs.~     400 mg BI 44847 as tablet, to investigate a food effect on the 400 mg tablet pharmacokinetic~     (PK) and to investigate relative oral bioavailability of 40 mg BI 44847 as solution vs. 40 mg~     BI 44847 as tablet.~   "
103554|NCT02211924|"~     Study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 44847~     in Japanese healthy volunteers~   "
103555|NCT02211911|"~     To investigate if bisacodyl (Dulcolax®) and sodium picosulfate (Laxoberal®) is excreted in~     breast milk of healthy lactating women after an oral administration of 10 mg once daily over~     a period of 8 days.~   "
103556|NCT02211898|"~     To investigate the efficacy and safety of BNS003 on subjective symptoms such as sensation of~     heaviness/tiredness(dullness), tension, tingling, pain, fever or itching associated with~     swelling of calf and ankle due to disorder of leg venous reflux.~   "
103557|NCT02211885|"~     Study to characterize the pharmacokinetics of 14C-radiolabeled BIRB 796 BS and its~     metabolites including excretion and mass balance of parent compound and radioactivity; to~     isolate, identify and quantify major radiolabeled metabolites of BIRB 796 in plasma, urine~     and feces~   "
103558|NCT02211872|"~     The primary objective of this study was to determine the maximum tolerated dose (MTD) of BI~     2536 BS in patients with advanced solid tumours. Secondary objectives were the evaluation of~     safety, efficacy, and pharmacokinetics of BI 2536 BS~   "
103559|NCT02211859|"~     Primary: Maximum tolerated dose (MTD) Secondary: Determination of the pharmacokinetic profile~     of BI 2536. Assessment of safety and efficacy.~   "
103560|NCT02211846|"~     The purpose of this study is to evaluate the pharmacokinetics as well as the safety and~     tolerability of mirabegron OCAS tablets after single-dose administration at different dose~     levels in children and adolescents with NDO or OAB.~   "
103561|NCT02211833|"~     Exploratory evaluation of safety, tolerability, pharmacokinetics (PK), maximum tolerated dose~     (MTD), and efficacy of BI 2536 administered in combination with pemetrexed~   "
103562|NCT02211820|"~     Background:~      - Chronic traumatic encephalopathy (CTE) is a brain disease caused in part by head injury.~     The brain changes from CTE can only be seen at autopsy. Researchers want to test a new brain~     scan to help diagnose CTE in living patients.~      Objective:~      - To determine if a new type of brain scan can detect changes that occur in chronic traumatic~     encephalopathy.~      Eligibility:~      - Adults age 18 60 with previous head injury or participation in certain sports.~      Design:~        -  Participants will be screened with:~        -  Physical exam~        -  Blood and urine tests~        -  Tests of thinking, mood, and memory~        -  30-minute magnetic resonance imaging (MRI) brain scan. A magnetic field and radio waves~          take pictures of the brain. Participants will lie on a table that slides into a metal~          cylinder. They will get earplugs for the loud knocking sounds.~        -  Visit 1: Participants will have a 70-minute PET scan of the brain with a small amount of~          a radioactive chemical. That will be injected through an intravenous tube (catheter) in~          each arm. A catheter will also be put into an artery at the wrist or elbow.~        -  Participants will lie on a bed that slides in and out of a donut-shaped scanner. A~          plastic mask may be molded to their face and head. Vital signs and heart activity will~          be checked before and during the scan.~        -  Blood and urine will be taken before and after the scan.~        -  Participants will be checked on by phone the next day.~        -  Visit 2: Participants will repeat Visit 1 with a different chemical and no artery~          catheter.~        -  Visit 3: Participants may have a spinal tap. Some fluid will be removed by needle~          between the bones in the back.~   "
103563|NCT02211807|"~     The purpose of this study was to compare the frequency of suicidality and suicide attempt~     among HIV patients starting treatment with Efavirenz and with patients starting treatment~     with other HIV medications.~   "
103564|NCT02211794|"~     Post-market study to confirm the safety and efficacy of the Journey II BCS knee prosthesis.~   "
103598|NCT02211339|"~     The purpose of this study is to investigate whether a peer led social skills training~     intervention is more effective than a social activity group (i.e. usual care) in improving~     social skills following brain injury.~   "
103599|NCT02211326|"~     The purpose of this study is to determine whether the international pharmacogenetic algorithm~     is better than the standard initiation dosing and whether the two algorithms are suitable for~     Chinese elderly patients.~   "
103565|NCT02211781|"~     Background:~      - The National Cancer Institute has been studying health risks to people in New Mexico at the~     time of the first nuclear bomb test. This was called the Trinity nuclear test. It took place~     in 1945. Researchers want to also learn about Native Americans and Hispanics at that time.~     They want to learn about their way of life and their diets. This will give a more complete~     picture of the health risks to people in New Mexico in 1945.~      Objectives:~        -  To learn about the activities and eating habits of Hispanic and tribal communities~          during the 1940s.~        -  To see if a group of Hispanic and Native Americans who were living in New Mexico in 1945~          can be gathered.~      Eligibility:~      - Native American or Hispanic adults who were alive in 1945. They must know firsthand about~     the lifestyle and diet in New Mexico at that time.~      Design:~        -  Participants will have 1 visit. They will be interviewed at a place like a library or~          office. They will answer questions about their lifestyle and diet around 1945. This will~          take up 60 90 minutes.~        -  Participants may agree to have their interviews taped. Their names will not be kept with~          their answers from the interviews.~   "
103566|NCT02211768|"~     Background:<TAB>~      - Many people with neurofibromatosis type 1 (NF1) get tumors of the nervous system. Finding~     malignant tumors early is important for removing them. Researchers want to find ways of doing~     this with scans and genetic testing.~      Objectives:~      - To learn more about neurofibromatosis type 1.~      Eligibility:~      - People age 10 and older with NF1 who have a benign tumor or have had a malignant one.~      Design:~        -  Participants will be screened in another study with medical history, physical exam, and~          urine and blood tests. They will have a magnetic resonance imaging (MRI) scan.~        -  MRI: Participants will lie on a table that slides into a metal cylinder. They will be in~          the scanner for 60 90 minutes, lying still for 15 minutes at a time. Participants will~          get earplugs for the loud sounds. They will get a contrast agent (dye) through a thin~          plastic tube (catheter) inserted in an arm vein.~        -  As part of their regular care, participants will have:~        -  FDG-PET/CT scan. They will get radioactive glucose (sugar) through a catheter in an arm~          vein.~        -  [18F]-FLT-PET/CT scan. This is like the FDG scan but with a different radioactive~          chemical.~        -  Biopsy. A piece of tumor tissue is removed with a needle. A piece of tissue from a~          previous biopsy may also be studied.~        -  Participants may have genetic testing. Blood will be taken. It will be tested along with~          biopsy samples. Researchers will explain the risks and procedures. They may notify~          participants if testing shows health problems.~        -  After this study, participants will continue their regular cancer care.~   "
103567|NCT02211755|"~     Background:~      - Researchers want to develop better ways to treat cancer. In this study, they will give~     people with cancer two drugs. These drugs have been used on their own to treat some blood~     cell cancers.~      Objectives:~      - To test the safety and efficacy of the drug combination of bortezomib and clofarabine.~      Eligibility:~      - Adults age 18 and over with advanced cancer that has progressed after receiving standard~     treatment or that has no effective therapy.~      Design:~        -  Participants will be screened with medical history, physical exam, and scans to measure~          their tumors. They will also have heart, blood, and urine tests. All of these may be~          done by their regular doctors.~        -  Participants will get the study drugs in 21-day cyles. They will stay at the clinic for~          week 1 of every cycle, then have 2 weeks off.~      <TAB>- Bortezomib will be injected under the skin on days 1 and 4.~      <TAB>- Clofarabine will be injected in a vein for days 1 5.~        -  During cycle 1 only, participants will go to the clinic or their doctor to have a~          physical exam and blood tests at the start of the second and third week.~        -  Participants will have a clinical evaluation throughout the study, before the start of~          each cycle, before receiving treatment.~        -  Participants may stay in the study as long as they are tolerating the drugs and their~          tumor is not getting worse.~        -  Participants will have follow-up for 30 days after the last dose of study drugs.~   "
103568|NCT02211742|"~     Dapagliflozin is a highly selective, reversible and potent inhibitor of the~     sodium-glucose-linked Transporter 2 (SGLT2), which was successfully investigated for its use~     as a treatment option in type 2 diabetes mellitus. The effect of dapagliflozin is an~     increased glucosuria, and it was shown that mean blood glucose concentrations and~     postprandial glucose excursion in special were significantly reduced in type 2 diabetic~     patients. Due to its mechanism-of action it seems likely that also type 1 diabetic patients~     will benefit from dapagliflozin. The present study is focused on the effects of dapagliflozin~     on fasting glucose homeostasis and postprandial glucose excursion in male type 1diabetic~     patients. Participants will subsequently receive 10 milligrams of dapagliflozin and placebo~     for 3 days (equals 2 x 30mg per cross-over period) in a double-blind, randomised, cross-over~     design. The effects will be measured via euglycemic hyperinsulinemic clamp studies (fasting~     glucose homeostasis) and euglycemic oral glucose tolerance clamp tests (postprandial glucose~     excursions).~   "
103569|NCT02211729|"~     The primary objective of this study is to determine whether addition of azithromycin (AZ) to~     Seasonal Malaria Chemoprevention (SMC) using sulphadoxine/pyrimethamine (SP) +amodiaquine~     (AQ) will provide an additional reduction in deaths and severe illness in young African~     children. The secondary objectives include an assessment of the safety and cost-effectiveness~     of the addition of AZ to SMC with SP+AQ.~      This a double blind, randomised, placebo controlled trial. The unit of randomisation will be~     the household. Children aged 3 - 59 months will be randomised to receive four cycles of~     either SP+AQ+AZ or SP+AQ+ placebo at monthly intervals during the peak malaria transmission~     season.~      Study Sites: Hounde district in Burkina Faso and in Bougouni district, Mali. Children of 3-59~     months of age at the start of each period of drug administration will be eligible for~     inclusion in the trial provided that parental consent is obtained. Children with a severe,~     chronic illness or known allergy to one of the study drugs will be excluded.~      Primary endpoint: Incidence of the combination of death or hospital admission for at least 24~     hours, not due to trauma or elective surgery during the intervention period~      Secondary endpoints:~        1. incidence of the primary endpoint during the whole study period~        2. attendance at a study health centre with a nonmalaria febrile illness~        3. attendance at a study health centre with malaria,~        4. the prevalence of moderate anaemia at the end of each malaria transmission season,~        5. nutritional status at the end of each malaria transmission season,~        6. prevalence of nasopharyngeal carriage with pneumococci and macrolide resistant~          pneumococci before and at the end of each malaria transmissions season,~        7. prevalence of resistance markers to SP at the end of the study,~      Sample size: 19,200 children (9600 in each country) will be enrolled.~   "
103570|NCT02211716|"~     The objective of this clinical investigation is to evaluate, in a controlled setting, the~     long-term (up to 12 months) safety and efficacy of the BeGraft Peripheral Stent Graft System~     (Bentley InnoMed) in clincial settings post CE-certification when used according to the~     indications of the IFU.~   "
105637|NCT02184676|"~     The purpose of this study is to determine whether early immunological markers (activation of~     autoreactive T lymphocytes) precede and are predictive of the appearance of autoantibodies in~     children born from type 1 diabetic parents.~   "
103572|NCT02211690|"~     This study aims to describe the proportion of participants with non-occupational~     post-exposure prophylaxis (NPEP) failure, defined as NPEP non-completion (including loss to~     follow-up) at week 4 or primary HIV infection at week 4 or 12, excluding those participants~     who should and do cease study drug because:~        1. The participant is found to be HIV-infected (study drugs will be ceased until the~          genotype of the infecting strain is determined)~        2. The source is found to be HIV-uninfected~      The primary study objectives are:~        1. To describe on-drug adherence and regimen completion rates of 28 days of NPEP using~          dolutegravir (DTG) with co-formulated emtricitabine-tenofovir (FTC-TDF)~        2. To describe the safety of 28 days of non-occupational post-exposure prophylaxis (NPEP)~          using dolutegravir with co-formulated emtricitabine-tenofovir~      The study is a multi-site, prospective, open-label, non-randomized trial. One-hundred (100)~     eligible participants will receive dolutegravir (one tablet) with co-formulated~     emtricitabine-tenofovir, two tablets, once daily for 28 days based on one of the following~     exposures:~        1. receptive anal intercourse with a source known to be HIV-infected; or~        2. receptive anal intercourse with a source of unknown HIV status; or~        3. insertive anal intercourse with a source known to be HIV-infected~      There will be 7 study visits over a 12-week period. Follow-up post NPEP is for 8 weeks i.e.~     to week-12 post-exposure. Any participant who is intolerant of dolutegravir will be managed~     at the investigator's discretion.~   "
103573|NCT02211677|"~     RATIONALE~        1. In patients with nasopharyngeal carcinoma, there is sometimes a discrepancy between~          actual clinical outcome and TNM stages because it is an anatomy-based system in which~          functional factors are not concerned.~        2. Hemoglobin, neutrophil to lymphocyte ratio and platelet count were proved to improve~          prognosis prediction of TNM staging system in our previous retrospective study.~      PURPOSE To validate that the prognostic index based on complete blood count and TNM system~     had higher prediction efficiency on survival in nasopharyngeal carcinoma than TNM system~     alone.~   "
103574|NCT02211664|"~     The objective of this clinical investigation is to evaluate the short- and long-term (up to~     24 months) outcome of treatment by means of dilation with the Passeo-18 Lux drug releasing~     balloon and by Pulsar-18 stent implantation in symptomatic (Rutherford 2-4) femoro-popliteal~     arterial stenotic or occlusive lesions.~   "
103575|NCT02211651|"~     The purpose of this study is to discover the characteristics of pregnant women which~     increases risk for their babies to develop diabetes, later on in life.~   "
103576|NCT02211638|"~     The puropose of this study is to gain an understanding of the actual use of candesartan~     cilexetil (Blopress) in patients with hypertension, and to examine the changes in parameters~     such as blood pressure.~   "
103577|NCT02211625|"~     The primary objective of this study is to evaluate the safety, tolerability, pharmacodynamics~     (PD) and pharmacokinetics (PK) of TRV734 given as a single dose (Part A) and as multiple~     ascending doses (Part B) in healthy subjects.~   "
103578|NCT02211612|"~     To investigate metabolic and molecular response to fatty acid-specific overfeeding in~     overweight subjects, in relation to changes in ectopic fat, lean tissue mass and insulin~     sensitivity~   "
103579|NCT02211599|"~     The purpose of the study is to determine how adding a carbohydrate beverage to a meal with~     different protein levels affects the rate at which one's body burns fats, sugars, and~     proteins.~   "
103580|NCT02211573|"~     Although approaches to reduce cardiovascular disease, coronary artery disease (CAD) remains~     the leading cause of mortality in the industrialized world. In order to reduce the~     deleterious effects of the atherosclerotic process, proposals for non-pharmacological~     treatment have been used, such as cardiac rehabilitation programs, with emphasis on exercise~     -based therapy. Traditionally aerobic exercises like biking, walking and jogging are~     conducted, however, alternative ways such as aquatic exercise training have been proposed,~     however, the cardiorespiratory adaptations in this population are not well documented in the~     literature. Thus, the aim of this study was to evaluate the effects of aquatic aerobic~     training (AAT) on body composition, autonomic modulation of heart rate (HR) and~     cardiorespiratory and metabolic variables in patients with CAD. This was a longitudinal~     clinical trial with a sample allocated for convenience, in which twenty-one patients were~     male, with a diagnosis of CAD, which were divided into control group (CG were studied, n=8),~     who was only assessed, and training group (TG, n=13). All patients underwent assessment of~     body composition, heart rate variability (HRV) at rest in the supine posture, and~     cardiopulmonary exercise testing (CPET), performed before and after the AAT program. The~     training protocol consisted of three sessions per week on alternate days for 16 weeks,~     totaling 48 sessions, which had lasted approximately one hour. The exercise intensity was~     prescribed between 80 and 110% of the first ventilatory threshold (VT1) obtained in CPET.~     Given that these parameters represent risk markers for cardiovascular events in the~     population studied, the results suggest that the AAT proposed in this study may be an~     important therapeutic strategy to be incorporated into cardiac rehabilitation programs.~   "
103581|NCT02211560|"~     The primary objective is to evaluate the efficacy and safety of phosphatidylserine (PS) on~     cognitive abilities in MCI~   "
103582|NCT02211547|"~     The primary goal of the study is to determine if there is a difference in pain levels~     following the use of low level laser therapy versus placebo and control after placement of~     elastomeric orthodontic separators in pediatric patients. To test this, the investigators~     will assess the patient's pain levels immediately following separator placement and 24 hours~     post-operatively but having patients rate their pain on a 10 cm Visual Analog Scale (VAS).~     Patients will be randomly assigned to one of three groups: treatment, placebo, and control.~     The aim of this study is to establish whether or not low level laser therapy can be used to~     reduce pain in pediatric patients following separator placement.~   "
103583|NCT02211534|"~     The purpose of this study is to investigate whether pulsed electromagnetic energy field~     (PEMF) therapy is effective in the treatment of persistent pain following total knee~     arthroplasty (TKA)~   "
103584|NCT02211521|"~     The purpose of this study is to compare the efficacy of platelet-rich plasma versus~     hyaluronic acid intra-articular injections for the treatment of osteoarthritis of knee joint.~      The hypothesis is that PRP intra-articular injection is comparable or even better than~     hyaluronic acid injection.~   "
109146|NCT02138799|"~     This study evaluates how a drug that alters liver enzymes (rifampin) affects the metabolism~     of enzalutamide in men by measuring concentrations of enzalutamide and its metabolites in~     plasma.~   "
103585|NCT02211508|"~     The purpose of this study is to test the safety and efficacy of a noninvasive cortical~     electrostimulation therapy known as Reduced Impedance Noninvasive Cortical~     Electrostimulation (RINCE) in the treatment of pain associated with fibromyalgia. Patients~     who meet the 2010 American College of Rheumatology criteria for fibromyalgia will receive up~     to 24 RINCE treatments delivered by a medical device called NeuroPoint. Approximately 200~     fibromyalgia patients will be randomized into one of two study groups. One of these groups~     will receive sham treatment, meaning they will receive no treatment at all, while the other~     group will receive active RINCE treatment. The study's primary outcome measure will be the~     difference between active and sham treatment groups in the mean change from baseline in~     patients' weekly worst pain scores. The study's hypothesis is that there will be a difference~     between treatment groups in primary outcome measure.~   "
103586|NCT02211495|"~     The investigators hypothesise that use of a medical device, that increases blood flow to the~     foot, will speed up ulcer healing in symptomatic diabetes~   "
103587|NCT02211482|"~     The purpose of this study is to evaluate the antiviral efficacy, safety and tolerability of~     dual therapy with 3TC and DTG as initial therapy among naïve HIV patients~   "
103588|NCT02211469|"~     The primary objective in this study is to assess if single doses of BMS-986104 that are safe,~     tolerable, and result in sufficient lymphopenia (50% to 70% reduction in absolute lymphocyte~     count) can be achieved without bradycardia or other adverse events in healthy male subjects.~   "
103589|NCT02211456|"~     We are investigating ways to help patients with heart failure, which is caused by damaged~     hearts which function less well, and cause symptoms of breathlessness, fatigue, lack of~     energy and swelling.~      Cardiac Resynchronisation Therapy (CRT) pacemakers are used to improve the pumping function~     of the main heart chamber in certain suitable people with heart failure. CRT requires a~     pacemaker with 2 wires, one placed inside the right heart chamber and one normally placed on~     the outside of the left heart chamber. These two wires act together to re-time the~     coordination of the heartbeat, which is known to improve heart function.~      The investigators are assessing whether they might be able to improve heart function even~     more by placing two wires on the inside of the left heart chamber, rather than one around the~     outside.~      The investigators wish to assess whether:~        1. Using two wires within the left side of the heart gives a greater increase in heart~          function than one.~        2. It is possible to choose the best spot inside of the heart by measuring the pattern of~          the heart beat.~        3. Is it possible to use a different type of heart monitor placed outside the body instead~          of a monitor wire inside the heart to assess improvement in heart function? They are~          investigating this in people with hearts that beat less effectively than normal.~   "
103590|NCT02211443|"~     The purpose of this study is to determine whether SCT200 is safe and tolerant in the~     treatment of metastatic colorectal cancer~   "
103591|NCT02211430|"~     To meet the Healthy People 2010 objective of increasing tobacco abstinence among pregnant~     women to 90%, new methods for treating nicotine addiction among pregnant women are needed. To~     this end, we propose to evaluate an innovative cognitive-behavioral smoking cessation~     intervention for low-income, minority women conducted in the prenatal and postpartum phases.~     Considering the strong link between tobacco use and cancer risk, the development of effective~     smoking cessation treatments has important health implications for cancer prevention and~     control initiatives. The aims to be addressed are:~      Aim 1: To compare an enhanced Cognitive-Behavioral Counseling (CBC) smoking cessation~     intervention with a Best Practice control condition (BP) for reducing smoking rates (i.e.,~     continued abstinence, 7-day point prevalence, and number of cigarettes smoked) in the short-~     and long-term among pregnant women. It is hypothesized that smokers receiving CBC will show~     reduced rates of tobacco use, versus those in the BP, over time.~      Aim 2: To evaluate the impact of the CBC intervention on the hypothesized mediators of~     behavior change (i.e., heightened risk perceptions; enhanced self-efficacy and reduced~     fatalistic beliefs; high pros and low cons of quitting; reduced emotional distress). It is~     hypothesized that the psychosocial factors will mediate the effect of the CBC intervention on~     change of smoking behaviors.~   "
103592|NCT02211417|"~     This study will compare the safety and efficacy of DS107G (2 g) to placebo in patients with~     moderate to severe atopic dermatitis.~      DS107G capsules (2 g) will be orally administered for 8 weeks, and will be compared against~     placebo.~      This study will enroll approximately 100 adult patients.~   "
103593|NCT02211404|"~     Prospective evaluation of sleep in children admitted to the Intensive Care Unit at Nationwide~     Children's Hospital to determine how children sleep while admitted to the Intensive Care Unit~   "
103594|NCT02211391|"~     Single macronutrients will be consumed before sleep by obese men. Overnight lipolysis will be~     measured with the microdialysis technique by measuring glycerol concentration and blood flow~     in abdominal adipose tissue. Morning fat oxidation will be measured with indirect~     calorimetry.~      The investigators hypothesize that carbohydrate intake will blunt the overnight lipolysis~     rate compared to casein protein and a non-caloric placebo. The investigators also hypothesize~     that casein and placebo will not be significantly different from each other in terms of~     overnight lipolysis.~   "
103595|NCT02211378|"~     This randomized controlled trial aims to determine if the stress response and performance of~     trainees who are observers in simulation training is similar to trainees who are actively~     participating in simulation training in the 'hotseat' during 3 consecutive simulation~     sessions.~      We hypothesize that trainees experience less stress when they are observers in the first 2~     simulation sessions. However, when they are placed in the 'hotseat' during the third session,~     their stress response, as well as their performance, will be similar to trainees who spend~     all 3 simulation sessions in the 'hotseat'.~   "
103596|NCT02211365|"~     The Registro Campania Salute Network (RCSN) is a prospective registry aimed at improving the~     management of essential hypertension by integrating the activity of general practitioners~     (GPs) with that of the hypertension specialist. It involves selected GPs homogeneously~     allocated in the regional area, and the Hypertension Clinic of the Federico II University in~     Naples, which served as co-ordinating centre. Through the RCSN system it is possible to store~     clinical data detected at each visit between the peripheral units and the co-ordinating~     centre and to support scientific analysis of the dataset.~   "
103597|NCT02211352|"~     The purpose of this study is to determine Korean red ginseng (KRG)treatment could decrease~     central blood pressure in subjects with hypertension.~   "
103600|NCT02211313|"~     A thin tube, called a ureteral stent, is inserted into the ureter and is commonly used as~     treatment of urinary stone disease. Stents are designed to help provide drainage of the~     kidney in the setting of an obstructing stone, or postoperative swelling of the ureter.~     Though their presence is only temporary, stents are associated with a significant amount of~     patient discomfort and bother, which can negatively impact overall satisfaction. Over the~     past decades, there have been refinements in stent technology and usage philosophy. Smaller~     and softer stents are now available for use in patients, though studies evaluating the~     relative benefits have been conflicting. The investigators aim to evaluate the effect of~     stent size and composition upon outcomes after the treatment of stone disease, including~     patient comfort and satisfaction.~   "
103601|NCT02211300|"~     The objective of this study is to demonstrate that the OptiScanner® is safe and can provide~     accurate blood glucose levels in critically ill subjects.~      Accuracy Hypothesis:~      The assessment of blood glucose level that results from the OptiScanner is comparable to the~     YSI 2300 STAT Plus™ Glucose and Lactate Analyzer (YSI Analyzer; YSI Life Sciences, Yellow~     Springs, OH).~      Safety Hypothesis:~      The OptiScanner has an acceptable risk/benefit profile for a system that can provide repeated~     automated blood glucose levels for critically ill subjects.~   "
103602|NCT02211287|"~     The purpose of this study is to evaluate the application of a best-practice Advance Care~     Planning (ACP) model for individuals living with dementia in a sample of nursing homes in~     Northern Ireland~   "
103603|NCT02211274|"~     Older adults prefer to live as in the community as long as possible. Creating a standardized~     treatment planning process that includes assessments of everyday competence and goal-setting~     techniques to help Veterans move from VA nursing homes back to the community can improve~     functional health, well-being, and quality of life for older Veterans. Research has shown~     that 29% of nursing home residents might be able to live safely in the community instead.~     Currently, VA provides nursing home care to more than 13,000 Veterans across the country,~     which costs about $3.3 billion a year. It is expensive for VA to provide nursing home care to~     these inappropriate residents and they are using limited resources that could be given to~     another Veteran with more urgent needs. The Everyday Competence Assessment and Planning for~     Community Transitions (ECAP-CT) toolkit will help these Veterans to move back into the~     community with the services and supports they need based on their individual level of~     everyday competence.~   "
103604|NCT02211261|"~     A first in human study to determine the safety, tolerability and pharmacokinetics of single~     and multiple ascending doses of PF-06293620 in subjects with Type 2 Diabetes Mellitus~   "
103605|NCT02211248|"~     Analyzing cardiovascular evaluation measures in the multidisciplinary and in the conventional~     treatment of hypertensive patients will provide better parameters for comparing the two~     approaches.~   "
103606|NCT02211235|"~     Current guidelines on the diagnoses and management of cystic fibrosis (CF) related diabetes~     recommend treatment for diabetes based on diagnostic criteria derived from adults with type 2~     diabetes. Increasing evidence supports treating early glucose abnormalities in cystic~     fibrosis patients to target CF specific outcomes, including lung function and nutrition~     (BMI-Body Mass Index). However, the criteria and timing of when to start insulin therapy in~     the `prediabetic' state are unclear. A more accurate characterization of blood sugar~     variability in youth with and without CF will help the investigators better interpret~     continuous glucose monitor (CGM) findings in patients with CF prediabetes and diabetes and~     more accurately identify those individuals at greatest risk for disease progression.~   "
103607|NCT02211222|"~     This Expanded Access Program (EAP) consists of a Prerandomization Phase and a Randomization~     Phase. Only subjects with radioiodine-refractory DTC who fulfill the eligibility criteria~     will be treated. These subjects will be treated until progression of disease or unacceptable~     toxicity.~   "
103608|NCT02211209|"~     The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 52~     weeks in patients with Familial Chylomicronemia Syndrome~   "
103609|NCT02211196|"~     This pilot clinical trial studies evidence-based tobacco cessation strategies in patients~     with cancer. Stop-smoking plans suggested by doctors may help patients with cancer quit~     smoking.~   "
103610|NCT02211183|"~     This is a post-marketing study to further assess the safety and effectiveness of the InSpace™~     device implantation in comparison to surgical repair of full thickness Massive Rotator Cuff~     Tear .~   "
103611|NCT02211170|"~     Study to determine the effect of a single dose BIRB 796 BS on systemic inflammatory responses~     induced by endotoxin in healthy humans~   "
103612|NCT02211157|"~     Study to assess safety, pharmacokinetics and pharmacodynamics of BIRB 796 BS in escalating~     multiple doses with and without a 64 g fat breakfast at the 50 mg dose level~   "
103613|NCT02211144|"~     Study to assess the safety and pharmacokinetics of BIRB 796 BS tablets administered as~     multiple daily doses at various dose levels~   "
103614|NCT02211131|"~     This is a phase 2, multicenter, randomized, open-label study to estimate the efficacy of~     talimogene laherparepvec as a neoadjuvant treatment followed by surgery compared to surgery~     alone in subjects with completely resectable stage IIIB, IIIC, or IVM1a melanoma.~   "
103627|NCT02210962|"~     There is accumulating experimental evidence to suggest the role of essential fatty acids~     (EFA) in neuronal migration, pruning and synaptic plasticity. These processes are implied to~     be dysfunctional on early stages of schizophrenia, according to neurodevelopmental~     hypothesis. Numerous epidemiological and clinical trial data support the benefit of EFA rich~     diets in reducing symptoms in schizophrenia. An EFA rich diet might be of particular~     importance at the beginning of the illness. As a relatively safe option, EFA supplementation~     would be a preferable add on therapy in treating individuals with a first episode of~     schizophrenia (FES) and a short duration of psychotic symptoms. No long term follow-up~     studies of EFA supplementation in FES patients were carried out. The demonstration of the~     efficacy of the prophylactic properties of EFAs in relapse prevention in FES patients would~     be a strong basis for further studies and prescribing EFAs for a large population of patients~     who are in the early stages of that debilitating illness.~   "
103628|NCT02210949|"~     Pre-treatment of patients with erythropoietin subcutaneously and iron supplement~     intravenously, in order to create a clinical pathway to minimize transfusion of red blood~     cells in a selected group of cardiac patients with an increased risk for blood transfusions~     in our cardiac surgery program.~   "
103615|NCT02211118|"~     A variety of medications have been used to treat the anxiety, discomfort, and fear associated~     with continuous and sudden episodic breathlessness in patients with advanced respiratory~     disease. Opioids and benzodiazepines, used alone or in combination, are commonly prescribed~     for this distressing symptom. Clinicians are concerned about the adverse effects of opioids,~     especially respiratory depression, so they frequently prescribe benzodiazepines. Recent~     studies have shown that benzodiazepine use is associated with increased adverse respiratory~     outcomes in older adults with Chronic Obstructive Pulmonary Disease (COPD).~      Dexmedetomidine may be an alternative to current drug therapies for breathlessness.~     Dexmedetomidine produces a dose dependent sedation, anxiolysis, and analgesia without~     respiratory depression or cognitive dysfunction. The drug can be administered intranasally to~     induce light to moderate sedation of several hours duration.~      The objective of the proposed research, a pilot study, is to assess the dose dependent safety~     and efficacy of intranasal dexmedetomidine in clinically stable patients with severe COPD.~     This will be accomplished in a staffed acute care setting with routine vital signs monitoring~     and pulse oximetry. Patients will be assessed objectively and subjectively for their level of~     sedation by validated sedation scales.~      This pilot study is an initial investigation of a drug with favorable pharmacologic~     properties in this patient population with distressing and difficult to treat symptoms. The~     pilot study may provide evidence that a larger trial is needed to confirm the study results,~     or evidence that additional study in symptomatic patients and treatment comparison trials~     should be pursued.~   "
103616|NCT02211105|"~     The purpose of this prospective observational research study registry is to examine whether~     two GERD surgeries (Laparoscopic Nissen Fundoplication (LNF) or Transoral Incisionless~     Fundoplication (TIF)) have similar outcomes in effectiveness, safety, post-operative side~     effects and post-procedure costs associated with episodes of care and any ensuing~     complications.~   "
103617|NCT02211092|"~     The purpose of this study is to develop an individually tailored home-based physical activity~     intervention for family caregivers of people with advanced cancer and assess the feasibility~     of a future randomized controlled trial (RCT) to test the effects of this intervention.~   "
103618|NCT02211079|"~     The purpose of this study is to assess the effects of single and multiple once daily doses of~     50 milligram (mg) of JNJ-54861911 on pharmacokinetics (PK) (study of the way a drug enters~     and leaves the blood and tissues over time) of caffeine, midazolam, and tolbutamide in~     healthy male participants.~   "
103619|NCT02211066|"~     The study is a single-centre, randomized, active controlled, open label clinical trial. The~     primary hypothesis is that ticagrelor will show superiority over clopidogrel immediately~     after CTO-PCI (chronic total occlusion - percutaneous coronary intervention)~   "
103620|NCT02211053|"~     The purpose of this study is to evaluate if the administration of an infusion of~     levothyroxine can improve heart function in organ donors~   "
103621|NCT02211040|"~     The investigators have developed an eHealth intervention based on self-regulation for the~     promotion of self-regulation of physical activity and fruit and vegetable intake among adults~     who visit general practice. Effectiveness of the intervention will be evaluated in a~     three-arm clustered quasi-experimental design in general practice.~   "
103622|NCT02211027|"~     Hypothesis The incidence of toxicity in patients receiving the tumor DNA-transfected~     fibroblast vaccine will be acceptably low and the immunologic response rate sufficiently high~     to warrant further study of this therapy~      The study of the vaccine will proceed in two stages after the method of Simon (102). In the~     first stage, 15 patients will be accrued and treated. If two or fewer objective immunologic~     responses occur, the study will be terminated. If 3 or more responses are observed, the study~     will proceed to the second stage, accruing an additional 22 patients. If the second stage is~     complete and a total of 9 or more immunologic responses are observed among the 37 patients~     treated, the treatment response rate for the vaccine will be considered high enough to~     warrant further study. Conversely, if the evaluation of the vaccine concludes at the first~     stage, or if 8 or fewer total immunologic responses occur after completing the second stage,~     the vaccine will not be considered for further study.~   "
103623|NCT02211014|"~     To characterize the safety profile of acalabrutinib with and without dexamethasone in~     subjects with relapsed or refractory Multiple Myeloma (MM)~   "
103624|NCT02211001|"~     The purpose of this study is to evaluate and compare the effects of three Exercise Movement~     Techniques Global Postural Reeducation(RPG), Pilates method and Segmented Dynamic Exercises~     (SDE) regarding muscular strength and endurance of the trunk, spine mobility and flexibility~     of the posterior muscle chain.~   "
103625|NCT02210988|"~     The investigators design a randomized, single blinded, control study to evaluate the~     therapeutic effect of acupuncture in acute ischemic stroke patients:~   "
103626|NCT02210975|"~     Sleeve gastrectomy (SG) has gained popularity as both a staged and a definitive procedure for~     morbid obesity due to its technical simplicity, low-morbidity and excellent results both for~     weight loss and control of metabolic syndrome. There are however reports of SG worsening~     pre-existing GERD or causing new-onset GERD. Because of this, patients with pre-existing GERD~     have been denied the benefits of SG. In addition, patients that develop post-op GERD cannot~     undergo traditional anti-reflux surgery since the gastric fundus that is required for~     fundoplication is removed during the SG. Hence, patients with post-SG GERD not adequately~     controlled with medication can only opt for the more invasive gastric bypass procedure as~     their only surgical treatment option.~      In a recently reported case study, an obese patient with severe GERD successfully treated~     with EndoStim underwent SG and maintained adequate GERD control with continued use of LES~     stimulation therapy. However electrical stimulation was not yet tested systematically in~     patients with prior gastric operation such as sleeve gastrectomy.~      This study will test the hypothesis that electrical stimulation is effective in control of~     GERD associated with SG.~   "
103642|NCT02210767|"~     This study will evaluate the effects of walnut-derived ALA and bioactives on multiple CVD~     risk factors, including central blood pressure, arterial stiffness indices, inflammatory~     markers, urinary isoprostanes, vascular adhesion markers, and changes in lipids and~     lipoproteins. Gut microbiome changes due to walnut consumption will also be assessed using~     the 16S rRNA gene.~   "
105638|NCT02184663|"~     Adapted Physical Activity (APA) program may provide an opportunity to improve symptoms for~     patients with unresectable pancreatic cancer.~      Thereby, it is proposed to conduct an open trial to assess effects of the APA program in such~     population~   "
103629|NCT02210936|"~     Brandeis University and University of South Carolina (USC) have joined together to develop~     the South Carolina Opioid Safety Initiative - Military (SCOSI-M), to develop an academic~     detailing (medical education) intervention for physicians and evaluate its effectiveness in a~     pilot study. The goal of the intervention is to increase the use of safe prescribing and~     prescription monitoring practices among primary care physicians. The research team will~     design and pilot an educational intervention for physicians who treat military personnel,~     veterans, and their families with prescription opioids. The overall aim of SCOSI-M is to~     prevent the onset or progression of prescription drug problems among Iraq and Afghanistan~     veterans, military members, and their families who are at high risk for developing problems~     if their treatment involves long-term use of an opioid.~   "
103630|NCT02210923|"~     Carotid baroreflex activation therapy (BAT) by the Rheos® system produces a sustained fall in~     blood pressure in patients with resistant hypertension. Since the activation electrodes are~     implanted at the level of the carotid sinus, it is conceivable that the nearby located~     carotid body chemoreceptors are stimulated as well. Physiological stimulation of carotid~     chemoreceptors not only raises respiration, but it also increases sympathetic activity which~     may in part counteract the effects of BAT. The aim of the present study is to investigate~     whether there is evidence for concomitant carotid chemoreflex activation during BAT. We~     hypothesized that there is no clinically relevant co-activation of the carotid body~     chemoreceptors during BAT in patients with resistant hypertension.~   "
103631|NCT02210910|"~     This is a post-marketing study to further assess the safety and effectiveness of the InSpace™~     in the study population in comparison to surgical RCT repair.~   "
103632|NCT02210897|"~     Cardiac troponin is the preferred biomarker for the diagnosis of acute myocardial infarction.~     Whereas the diagnosis is based on an increase and/or decrease in the concentrations of~     cardiac troponins with at least one value above the 99th percentile value of the reference~     population together with the evidence of ischemia, serial sampling is needed. Knowledge of~     the variation in cardiac troponin levels over time in individuals in a normal rest state (not~     during an acute myocardial infarction), also called the biological variation, is important~     regarding the interpretation of the serial cardiac troponin levels. A recent study by our~     group showed a circadian rhythm in cardiac troponin levels. This circadian rhythm is~     important regarding the interpretation of the serial cardiac troponin levels.~      Increased cTnI and cTnT concentrations are common in subjects with renal impairment. The~     mechanism of the elevated concentration of cTn in these subjects is still unclear. It is~     hypothesized that impaired renal clearance contributes to elevated levels of cTn. However, it~     is not clear whether renal function affects the biological variation and circadian rhythm of~     cTn. The monitoring of the biological variation and circadian rhythm of cTn in subjects with~     impaired renal function creates the opportunity to assess the effect of renal clearance on~     the circadian rhythm of cardiac troponins.~   "
103633|NCT02210884|"~     Synthesis of vitamin D in the skin through the action of sunlight is a major source of~     vitamin D in parts of the world where foods are not fortified with the vitamin. Skin~     pigmentation (color), dress habits and season are some of the factors that limit sun exposure~     and affect vitamin D synthesis in the skin. Maternal vitamin D status is especially important~     to meet infant needs when newborns are not supplemented with vitamin D. In Ethiopia, vitamin~     D status of lactating women and infants and breast milk vitamin D concentration have never~     been assessed. The purpose of this study is to assess changes in maternal and infant markers~     of vitamin D status before and after vitamin D supplementation of the lactating mothers.~   "
103634|NCT02210871|"~     This trial is conducted in Europe. The aim of this trial is to investigate the~     pharmacokinetics (the exposure of the trial drug in the body), safety and tolerability after~     a single injection of semaglutide in subjects with mild, moderate or severe hepatic~     impairment compared to subjects with normal hepatic function.~   "
103635|NCT02210858|"~     This phase I/II trial studies the side effects and how well tipifarnib works in treating~     patients with chronic myeloid leukemia, chronic myelomonocytic leukemia, or undifferentiated~     myeloproliferative disorders. Tipifarnib may stop the growth of cancer cells by blocking some~     of the enzymes needed for cell growth.~   "
103636|NCT02210845|"~     The objective of this study is to investigate whether a behavioral modification intervention~     in the form of either a 6-month supervised training program or a 6-month financial incentive~     weight loss program, results in improvement of diabetes outcome such as overall sugar control~     and lipid control.~   "
103637|NCT02210832|"~     Investigators will examine whether adding financial incentives to current best practices for~     smoking cessation during pregnancy (i.e., referral to pregnancy-specific counseling using a~     telephone quit line) increases cessation rates and improves infant health. While more~     expensive upfront compared to best practices alone, the investigators hypothesize that this~     treatment approach will be economically justified by the later cost savings associated with~     more women quitting, having healthier babies, and needing less healthcare. It should also~     help to reduce the greater risk for health problems often seen among those who less well off~     economically.~   "
103638|NCT02210819|"~     Following the findings of the clinical trials in drug development, this global~     non-interventional cohort field study will investigate rivaroxaban under clinical practice~     conditions in comparison with current standard of care for patients with acute venous~     thoromboembolism (VTE).~      The main goal is to analyze long-term safety in the use of rivaroxaban in the treatment of~     acute VTE in routine clinical practice.~   "
103639|NCT02210806|"~     This study evaluates the efficacy, dose-ranging and safety profiles of A006, an Albuterol dry~     powder inhaler (DPI), in the dose range of 110 to 220 mcg per dose in comparison to a DPI~     Placebo Control and an Albuterol metered dose inhaler (MDI) Active Control.~   "
103640|NCT02210793|"~     The aim of the study is to evaluate the severity of dry eye syndrome following excimer laser~     vision correction using no-touch all-laser photorefractive keratectomy in comparison to~     conventional lasik~   "
103641|NCT02210780|"~     This is a 32-week, randomized, double-blind, placebo-controlled, parallel-group study~     assessing immunization responses to vaccination in adults with moderate to severe atopic~     dermatitis who are treated with subcutaneous dupilumab.~   "
103703|NCT02209961|"~     A prospective study reporting on Ex-PRESS shunt implantation alone or combined cataract and~     glaucoma surgery.~   "
103643|NCT02210754|"~     This trial was the initial characterization of the blu™ products being studied, with the~     purpose of gaining an understanding of the exposure to nicotine and craving reduction~     attained following use of blu™ e-cigarettes by adult smokers. Two types of exposures were~     utilized: a single controlled administration and a short-term ad lib use. As smoking~     behaviors vary from smoker to smoker, a controlled administration allows for some~     standardization of nicotine dose for each of the study products to better understand their~     uptake characteristics as well as urge reduction achieved under controlled conditions.~     Further evaluation under ad lib product use conditions provides insight into product~     self-administration behaviors that will allow subjects to achieve acceptable levels of urge~     reduction. Comparisons were made to evaluate differences between blu™ formulations as well as~     to the market-leading conventional cigarette, Marlboro Gold King Size (Marlboro cigarette').~   "
103644|NCT02210741|"~     Graves' disease (MIM 27500) is the leading cause of hyperthyroidism worldwide. The prevalence~     of Graves' disease is quite high (2.7% in women), and there is solid evidence of genetic~     predisposition. Despite its clinical and scientific significance, Graves' disease is still~     mysterious in terms of its susceptibility genes or pathophysiological mechanisms. The immune~     repertoire, being the sum of T and B lymphocytes in a body at any given time, is both a~     snapshot and a historical record of a person's immune function. Thanks to the power of~     next-generation sequencing (NGS), massively parallel sequencing of the B cell and T cell~     receptors suddenly becomes plausible, and opens a door for many creative approaches to study~     immune related diseases. The ultimate goal of this project is to use both the NGS deep~     sequencing and immune repertoire experiment to perform Graves' disease sub-group genetic fine~     mapping, and to identify Graves' disease-specific T cell and B cell receptors. Furthermore,~     using the immune repertoire approach, investigators want to study the critical epitopes of~     thyroid auto-antigens, and to delineate the pathophysiological steps in various disease~     stages and in various sub-groups. Investigators expect to solve the immune repertoire of~     Graves' disease of different sub-group presentations and at various disease activity stages.~   "
103645|NCT02210728|"~     The purpose of the project is to evaluate the efficacy of cognitive behavioral therapy (CBT)~     for adults with attention deficit hyperactivity disorder (ADHD) with and without stimulant~     medication and compare it to medication alone. Subjects will be randomly assigned to~     stimulant medication only, CBT only and combined CBT and stimulant medication group. Patients~     will be evaluated at baseline, following mediation optimization (for medicated groups),~     following 12 months of treatment, after 3 months of follow up, and after 6 months of follow~     up. The investigators hypothesize that the combined group will have the best outcome at all~     evaluation points. ADHD in adults is associated with significant morbidity and impaired~     academic, occupational, social, and emotional functioning. Developing optimal treatment~     approaches for this population is key in improving their functioning.~   "
103646|NCT02210715|"~     People infected with HIV are living longer thanks to the use of antiretroviral therapy~     (cART). In aging HIV persons, other factors are associated with early death. One of the major~     factors is liver disease, which can be due to liver infections or reasons such as fatty~     liver. Fatty liver in the general population is a serious problem, affecting 30% of Canadian~     population. A specific type of fatty liver characterized by much inflammation, named~     nonalcoholic steatohepatitis (NASH) can lead to cirrhosis and death. Persons living with HIV~     can be at increased risk of NASH because of toxic effect of certain types of cART on the~     liver, obesity and other metabolic factors (for example diabetes). Some scientific data~     suggest that newer cART are associated with less fatty liver and liver damage. However, NASH~     has not been studied in detail in persons living with HIV. One reason for the lack of~     research is one of the only ways to detect liver disease is to undergo liver biopsy which can~     be painful and has complications. Recently, a new non-invasive technology (Fibroscan) has~     been developed which can tell doctors how much a liver is damaged and how much fat it~     contains without pain or complications. Moreover, a simple test measuring a specific protein~     in the blood, the cytokeratin 18 (CK-18), can help the diagnosis of NASH. We will study the~     effect of switching cART to newer types of HIV medication in patients with a non-invasive~     diagnosis of NASH done by Fibroscan and cytokeratin 18. We expect that switching older cART~     to less hepatotoxic drugs will lead to improvement of liver damage, fatty liver and NASH~     diagnosed by Fibroscan and cytokeratin 18. To evaluate this approach we plan to recruit 58~     consenting HIV mono infected patients with non-invasive diagnosis of NASH and/or fatty liver~     with liver damage. Participants will undergo Fibroscan, a blood test for cytokeratin 18, a~     complete physical examination and laboratory tests every 3 months for 12 months, then at 18~     and 24 months. The effect of the switching of HIV medications will be recorded. We anticipate~     that the current study will provide evidence for reduction of inflammation and liver damage~     with newer cART for treatment of HIV infection.~   "
103647|NCT02210702|"~     This is a prospective, randomized, controlled cohort study. This study will look at the~     effect of Ethinyl Estradiol 35mcg/Norethindrone 1mg and Ethinyl Estradiol 20~     mcg/Norethindrone 1mg on postpartum depressive symptoms and sexual function scores when~     compared to a control group using no hormonal contraception. Depressive symptoms and sexual~     function will be measured using the Edinburgh Postnatal Depression Scale (EPDS), Arizona~     Sexual Experiences Scale (ASEX), and Brief Index of Sexual Functioning for Women (BISF-W).~     Participants will begin taking the medication at Week 3 postpartum, and these outcomes will~     be measured at baseline (0-1 day postpartum), Week 3, and Week 6-7. The investigators~     hypothesize that there will be an ethinyl estradiol dose related response in EPDS, ASEX, and~     BISF-W scores at Week 6-7, which would indicate a decrease in depressive symptoms and~     increase in sexual function in both of the oral contraceptive groups.~   "
103648|NCT02210689|"~     A multi-center, double-blind, randomized, placebo controlled, parallel-group study, comparing~     Clindamycin phosphate vaginal cream 2% (Watson Laboratories, Inc.) to Clindesse® (Ther-Rx™,~     Clindamyin Phosphate Vaginal Cream 2%) and both active treatments to a placebo control in the~     treatment of bacterial vaginosis in non-pregnant women.~   "
103649|NCT02210676|"~     Aim:~      The purpose of the study is to learn more about how a person recovers after treatment for~     mallet finger injury. The investigators want to identify the best outcome after mallet finger~     injury and how to improve treatment strategies.~      Primary null hypothesis:~      There are no statistically significant factors associated with extensor lag between 4 weeks~     and 4 months after immobilization is discontinued for a mallet finger among demographic,~     injury, and treatment factors.~      Secondary null hypothesis:~      There are no statistically significant factors associated with PROMIS upper extremity~     function between 4 weeks and 4 months after completion of immobilization for a mallet finger~     among demographic, psychological, injury, and treatment factors.~   "
103650|NCT02210663|"~     This is a Phase 1 study to evaluate the tolerability, safety, pharmacokinetics and~     preliminary efficacy of single agent Veliparib in Japanese subjects with advanced solid~     tumors.~   "
103725|NCT02209675|"~     Assessment of the role of tissue C4d complement fragments in liver biopsy as a new marker for~     differentiating between acute rejection and Hepatitis C (HCV) recurrence in recipients post~     living donor liver transplantation (LDLT) .As each condition require different treatment~   "
103651|NCT02210650|"~     Patients with a ureteral (the tube that leads from the kidney to the bladder) stone often~     also have small stones in the kidney (frequently visible on CT). If these small kidney stones~     are determined to be asymptomatic (not causing any problems or pain), then most urologists~     will simply remove the symptomatic ureteral stone and leave the additional stones in the~     kidney above. However, the investigators know that the ureteral stone started in the kidney.~     This means that the small stones remaining in the patient's kidney may cause problems later.~     The purpose of our research is to test if removing small stones from the kidney prevents~     future stone episodes~   "
103652|NCT02210637|"~     To evaluate the association of non attendance at scheduled appointments with visits in the~     emergency department, hospitalizations and mortality during one year follow up.~   "
103653|NCT02210624|"~     The purpose of study is to evaluate the safety and efficacy of autologous bone marrow-derived~     stem cells therapy in patients with anaerobic (hypoxic) brain injury. Stem cell therapy is an~     emerging alternative treatment modality in incurable and intractable neurological disorders.~     This pilot study aims to evaluate the feasibility and safety of stem cells in anaerobic brain~     injury.~   "
103654|NCT02210611|"~     The purpose of this study is to prove that a higher clinical pregnancy rate can be achieved~     with a 42 to 44 hour time interval between ovulation trigger and intrauterine insemination~     than a 36 to 38 hour time interval in stimulated cycles utilizing gonadotropins and GnRH~     antagonists.~   "
103655|NCT02210598|"~     This study represents the first randomized trial comparing traditional inpatient induction~     with a transcervical foley catheter versus outpatient induction with immediate removal of a~     transcervical foley catheter. The immediate removal technique allows the induction process to~     begin in the hospital setting, but allows the patient to go home without a foreign body in~     situ. The investigators hypothesize the outpatient group will spend less time hospitalized~     prior to discharge. Additionally, the investigators will explore the vaginal delivery rates~     and maternal/neonatal safety profiles between groups.~   "
103656|NCT02210585|"~     The study was designed to test the following hypotheses:~      Main Objective:~      To compare the level of spontaneous physical activity at 3 months after re-entrainment by~     multi-site electrical stimulation (m-ES), measured by actigraphy over 7 days, compared to~     conventional care (lifestyle and dietary advice and placebo (simulated) electrostimulation)~     (control arm).~      Secondary Objectives:~      To compare the metabolic, inflammatory, cardiovascular and functional parameters, physical~     activity, quality of life and quality of sleep, at 3 months and at 2 years in the two groups.~      Design:~      We will conduct a multicenter controlled study vs. reference care with randomization into two~     parallel groups and double-blind (placebo electrostimulation). Patients will have the ES~     material available at home and will be supervised by monthly visits over 3 months and by~     telephone follow-up for two years. The study size calculation is based on physical activity,~     the percentage of lean body mass and arterial stiffness measured in the OBEX study.~      This project will determine whether the training strategy is effective for increasing~     physical activity and/or in inducing significant metabolic and cardiovascular effects in~     these patients after 2 years. In addition, it provides a solid base of investigation for the~     study of the interactions between muscle contraction and cardio-metabolic health with greater~     precision.~   "
103657|NCT02210572|"~     It has been shown that patients complaining of gas-related symptoms significantly improve on~     a diet low in fermentable residues. However, other studies suggest that some non-absorbable,~     fermentable meal products (prebiotics) that serve as substrate to colonic bacteria, produce~     beneficial effects to the host, including improvement of abdominal symptoms. The aim of the~     study is to compare the effects of a diet low in fermentable residues versus a diet~     suplemented with prebiotics on intestinal microbiota composition, microbiota activity~     (intestinal gas production) and digestive symptoms.~   "
103658|NCT02210559|"~     This is a Phase 1/2 trial to evaluate the safety, tolerability and efficacy of FG-3019~     administered with gemcitabine and Nab-paclitaxel in the treatment of locally advanced,~     unresectable pancreatic cancer.~   "
103659|NCT02210546|"~     A multicenter randomized controlled trial to evaluate the performance of MRI, in terms of~     sensitivity, specificity, and predictive value, in the screening of women at intermediate~     risk of breast cancer.~      Two surveillance programs will be compared. Women will be randomly assigned with a 1:1 ratio~     to:~        1. Yearly two-view mammography (Mx) and breast ultrasonography (US) or~        2. Yearly MRI.~   "
103660|NCT02210520|"~     The low level laser therapy has a better effect in decrease the pain than ultrasound~     therapeutic.~   "
103661|NCT02210507|"~     The goal of the research study is to determine the absorption, metabolism, and bioconversion~     of carotenoids such as beta-carotene to vitamin A from gari made with biofortified cassava~     compared to a mixture of red palm oil and gari made from typical white cassava.~   "
103662|NCT02210494|"~     Evaluate the safety of Secretrol® in patients undergoing endoscopic mucosal resection for~     early adenocarcinoma of the esophagus.~   "
103663|NCT02210481|"~     Comparison between intravitreous glucose rate and macular thinning measured by Ocular~     Coherence Tomography (OCT) at 3 months post vitrectomy for retinal detachment or epimacular~     membrane. Hypothesis : Association between post-operative macular thickness and intravitreous~     glucose rate~   "
103664|NCT02210468|"~     The mechanism of Osteoarthritis (OA) is complex, however the investigators know that~     cartilage breakdown follows changes in certain cells in the cartilage called chondrocytes,~     leading to proteases that break down cartilage. There is a protein in the human blood called~     alpha-2-macroglobulin that can trap these proteases and prevent the breakdown of cartilage.~     Cytonics developed a device that use the patient's own blood to remove all cells and~     concentrate alpha-2-macroglobulin to be injected in the painful knee due to osteoarthritis.~   "
103665|NCT02210455|"~     Prenatal alcohol exposure can lead to a myriad of adverse developmental outcomes in children,~     and is the leading cause of mental disability in Canada. The term fetal alcohol spectrum~     disorders (FASD) was established to encompass the full spectrum of teratogenic effects~     induced by alcohol. FAS is believed to occur in approximately 1 to 3 per 1000 live births in~     North America, and it is estimated that FASD may occur as frequently as 1 in 100 live births,~     making this a public health problem of epidemic proportion. Even though considerable efforts~     have been aimed at identifying children with FASD, the need for access to services and~     supports for Canadian families affected by FASD remains unfulfilled. Additionally, there is~     little empirical data available to influence policy change in how these services and supports~     are delivered.~      A key recommendation contained in the Public Health Agency of Canada's (PHAC) Fetal Alcohol~     Spectrum Disorder (FASD): A Framework for Action document was the need to determine the types~     of supports children with FASD and their families require and to develop appropriate~     mechanisms to provide these services at the community, provincial/territorial and federal~     levels. This identified need forms the basis of the current proposal.~      Although a variety of psychosocial interventions have been developed to treat~     neurobehavioural disorders, relatively little research has been conducted that is~     specifically aimed at improving the behavioral challenges identified in children with FASD.~     Thus, we hypothesize that (i) a FASD-specific parent/guardian training intervention can be~     developed using input from major stakeholders to meet the current limitations in access for~     families seeking services and supports; and (ii) this intervention and its evaluation will~     provide evidence for feasibility and efficacy to support changes in policy by key~     decision-makers and provide the basis for developing promising practices in the area of~     interventions for families affected by FASD. This grant will link academic teams with~     parents/guardians and decision makers to develop and evaluate a training program for the~     parents/guardians of children with FASD.~      Participants will be recruited from across Canada. The specific objectives of the proposed~     research program, which will be addressed in three inter-related studies, are to:~        1. Develop an Internet-based intervention program for parents/guardians of children with~          FASD between the ages of 4-12 years, that is based on information collected from~          interviews completed by major stakeholders (e.g., parents/guardians, clinicians,~          decision-makers, community-based organizations);~        2. Evaluate the feasibility (usability) of the intervention; and~        3. Obtain data on outcomes from the randomized controlled trial This research will adopt an~          integrated knowledge translation and exchange approach where knowledge production,~          dissemination, uptake and usage will occur seamlessly throughout the project and~          researchers and knowledge users are engaged in the project right from its inception.~      The intervention will be based on the Strongest Families program that is designed to help~     families learn to deal with common childhood problems in the comfort and privacy of their~     home, and provide treatment and care via telephone contact with trained coaches, written~     manuals, videotapes, and audiotapes. This program has been successful in children~     neurodevelopmental disorders; and will be adapted for use in the FASD population, as children~     with FASD, share many of the same behavioral characteristics.~   "
103666|NCT02210442|"~     A multicenter study to evaluate the effectiveness of a teaching strategy based on the~     incorporation of educational games with simulated settings versus usual practice based on~     diffusion for the implementation of clinical practice guidelines in Family Medicine Residency~     Program. The impact of the new strategy will be measured in improving knowledge and skill~     acquisition in clinical decision making of Family Medicine Residency Program after 6 months.~     Effectiveness will also be measured a month and 12 months after intervention.~   "
103667|NCT02210429|"~     We hypothesize that patients who receive a supraclavicular block via Angiocath, placed~     intra-operatively and dosed post-operatively following neurologic examination, will have~     lower pain scores, lower use of intravenous morphine equivalents in the post-anesthesia care~     unit, and lower rates of intervention for post-operative nausea and vomiting. We also~     hypothesize that patients receiving this nerve block had the same rates of nerve damage as~     the patients who did not receive a block and that there will be no demonstrable safety~     concerns with this block.~   "
103668|NCT02210416|"~     Laparoscopic inguinal hernia repair is becoming increasingly popular mainly because of~     short-term advantages compared to open hernioplasties with mesh. In the prevailing economic~     climate, the total costs of treatment is a subject of intense research. This study is~     designed to evaluate the results of open and laparoscopic inguinal hernia repairs, with a~     special emphasis in costs of treatment, complications and convalescence.~   "
103669|NCT02210403|"~     The purpose of this study is to determine whether tDCS in combination with motor training can~     improve hand and arm function in stroke patients.~   "
103670|NCT02210390|"~     Aim:~      To assess the Feasibility RCT of the efficacy of a culturally adapted psychological~     intervention for Bipolar disorder in Pakistan~      Design:~      Randomized Control Trial~      Setting:~      Psychiatric Departments of different Hospitals in Karachi.~      Participants:~      A total of 36 Bipolar disorder patients will be randomized to psychological Intervention and~     treatment as usual arm.~      Intervention:~      Culturally Adapted psychological intervention for bipolar disorder~      Outcome measure:~        -  Acceptance of intervention in terms of attending session and dropouts~        -  Knowledge and attitudes towards bipolar disorder~   "
103671|NCT02210377|"~     Intradialytic hypotension (IDH) is a most frequent complication of hemodialysis (HD) and may~     contribute to cardiovascular events and high mortality. The etiology of IDH is~     multifactorial; therefore, it remains a challenging problem in the management of HD patients.~     Because moxibustion (MO) at specific points can influences hemodynamics, we hypothesize that~     Tianjiu (auto-MO) at the traditionally used meridian points will reduce the severity of~     hypotension in patients who undergo HD.~   "
103672|NCT02210364|"~     Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin~     (PM01183) in Combination with Capecitabine in Patients with Unresectable Metastatic Breast~     Cancer (MBC), Pancreatic Cancer (PC) or Metastatic Colorectal Cancer (CRC) to determine the~     recommended dose (RD) of PM01183 in combination with capecitabine, to characterize the safety~     profile, to explore the feasibility of PM01183 dose optimization, to characterize the~     pharmacokinetics (PK), to obtain preliminary information on the clinical antitumor activity~     of this combination and to conduct an exploratory pharmacogenomic (PGx) analysis.~   "
103673|NCT02210351|"~     The asses and evaluate whether trans apical access for TAVR is associated with apical~     dysfunction.~   "
103674|NCT02210338|"~     The study aims to determine the better device to facilitate intubation in patients with a~     limited neck movement and small mouth opening. This may help anesthesiology as well as~     emergency medicine practitioners and departments to decide when choosing between these two~     conceptually similar device. The hypothesis to be tested is that the C-MAC® is more superior~     when compared to the Bonfils Intubation Fibrescope in success of intubation, time to~     intubation and complication rate in patients with a fixed cervical collar.~   "
103675|NCT02210325|"~     This study will compare a single dose of oral solithromycin to the standard of care~     (intramuscular ceftriaxone plus oral azithromycin) in the treatment of patients with~     urogenital gonorrhea. A completed open-label Phase 2 study with single doses of solithromycin~     resulted in 100% microbiological eradication in male and female patients with uncomplicated~     urogenital gonorrhea.~   "
103676|NCT02210312|"~     Postoperative cognitive dysfunction (POCD) describes a condition where cognitive functions~     such as attention, perception, concentration, learning, abstract thinking and problem solving~     are impaired postoperatively. These changes can be resolved after weeks and months. In some~     cases, changes are permanent.~   "
103677|NCT02210299|"~     People are, especially in industrialized countries, exposed to a growing number of ubiquitous~     chemical substances. It thus increases human exposure pathways: diet, inhalation, soil and~     dust dermal contact…), notably for semi-volatile organic compounds. Diet is generally sought~     to contribute the most to total exposure for many chemicals, the relative contribution of~     each pathway is nevertheless poorly described, and can be different among populations. This~     is in particularly the case For young children, who can be more exposed via the environment,~     because of frequent contact with object and dust and hand to mouth behaviors. Children are in~     addition considered more sensitive to chemical risk due to their maturating systems.~      In this context, the objective of this project is to characterize the young children's~     exposure to a particular class of semi volatile organic compounds. It will encompass the~     relative contribution of different pathways to the external dose, and to try to match the~     internal and external doses with a physiologically based pharmacokinetic (PBPK) model for~     molecules for which it is possible.~      The present demand concerns a feasibility study on 2 children, for Perfluorinated Alkylated~     Substances (PFAS), used in numerous consumer products.~   "
103678|NCT02210286|"~     The purpose of this study is to examine the effects of supplementing Magnesium L-Threonate in~     people with mild to moderate dementia . The investigators goal is to understand whether~     Magnesium L-Threonate will be associated with improvement in memory and brain function.~   "
103679|NCT02210273|"~     The SUCCESS Trial is designed to determine whether the Solace Bladder Control System is safe~     and effective for the treatment of Stress Urinary Incontinence (SUI) in adult females.~   "
103704|NCT02209948|"~     The purpose of this study is to show if prolonging treatment with temozolomide to 12 cycles~     improve progression-free survival in patients with glioblastoma included in this study,~     randomized according to o6-methylguanine-DNA-methyltransferase (MGMT) methylation status and~     residual disease or not, to receive an additional 6 cycles of temozolomide.~   "
103720|NCT02209740|"~     Renal outcome could be different after switching tenofovir to different antiretroviral~     strategies, in case of renal toxicity. Therefore, it is necessary to evaluate the importance~     of renal evolution in these patients, in terms of grade and time to renal improvement,~     according to the different options after interrupting tenofovir. The aim of this study was to~     explore the renal outcome after tenofovir according to new antiretroviral regimen.~   "
103680|NCT02210260|"~     Limiting surgical stress and managing postoperative pain are well understood to influence~     recovery and outcome from major surgery for colorectal cancer and both are fundamental~     aspects of enhanced recovery protocols.~      Traditional approaches for dealing with these problems such as epidural or patient controlled~     intravenous opioid analgesia are associated with problems that may be detrimental to~     postoperative recovery and surgical outcome. As a result there is evidence in the literature~     of increasing interest in alternative techniques such as intrathecal anaesthesia or~     continuous wound infusion of local anaesthetic, however nobody has examined the effect of~     combining the techniques or their impact on the surgical stress response.~      We intend to compare patients undergoing major resections for colorectal cancer receiving~     intrathecal anaesthesia in combination with a wound infusion of local anaesthetic with those~     receiving a continuous wound infusion alone. We will examine the surgical stress response and~     postoperative pain control in addition to objective measures of postoperative recovery.~      We suggest that our approach will attenuate the surgical stress response and provide optimal~     pain control that will ultimately translate in improved recovery and outcome following~     surgery for colorectal cancer.~   "
103681|NCT02210247|"~     The purpose of this study is to evaluate the safety and pharmacokinetics of redosing EXPAREL~     via local subcutaneous infiltration in healthy volunteers.~   "
103682|NCT02210234|"~     The purpose of this research was to understand the effects of bioactive compounds found in~     wheat cereal on human immunity. Subjects came in for a baseline blood draw, consumed whole~     wheat bran cereal daily for 21 days, and returned for a final blood draw. Immune function~     assays were performed at both sampling times. It was predicted that eating wheat bran would~     benefit immune function.~   "
103683|NCT02210221|"~     The research aims of the CENTER-TBI study are to:~        1. better characterize Traumatic Brain Injury (TBI) as a disease and describe it in a~          European context, and~        2. identify the most effective clinical interventions for managing TBI.~      Specific aims~        1. To collect high quality clinical and epidemiological data with repositories for~          neuro-imaging, DNA, and serum from patients with TBI.~        2. To refine and improve outcome assessment and develop health utility indices for TBI.~        3. To develop multidimensional approaches to characterisation and prediction of TBI.~        4. To define patient profiles which predict efficacy of specific interventions (Precision~          Medicine).~        5. To develop performance indicators for quality assurance and quality improvement in TBI~          care.~        6. To validate the common data elements (CDEs) for broader use in international settings,~          and to develop a user-friendly web based data entry instrument and case report form~          builder.~        7. To develop an open database compatible with Federal Interagency Traumatic Brain Injury~          Research (FITBIR).~        8. To intensify networking activities and international collaborations in TBI.~        9. To disseminate study results and management recommendations for TBI to health care~          professionals, policy makers and consumers, aiming to improve health care for TBI at~          individual and population levels.~       10. To develop a knowledge commons for TBI, integrating CENTER-TBI outputs into systematic~          reviews.~   "
103684|NCT02210208|"~     Part A The primary objective of Part A will be to verify performance and safety of Mepitel®~     Ag, a meshed, non- adherent soft silicone wound contact layer containing silver in the~     treatment of skin grafts in surgical burn patients.~      Part B The primary objective of Part B will be to examine the usefulness of Mepilex® Transfer~     Ag as an adequate option for donor site healing.~   "
103685|NCT02210195|"~     The primary aim of the supplemental study is to provide POC testing of aprepitant as a~     treatment for comorbid alcohol and cannabis dependence. The data analysis plan specified in~     the parent grant will likewise be applied to the supplemental project to test for effects of~     aprepitant vs placebo on measures of alcohol and cannabis use and protracted withdrawal. The~     primary hypothesis is that subjects treated with aprepitant will have significantly less~     alcohol and marijuana use than subjects treated with placebo.~   "
103686|NCT02210182|"~     The purpose of this study is to investigate on the Hepatic Uptake, Pharmacokinetics, Safety~     and Tolerance of a New Oral Pentamidine Formulation in Hepatocellular Carcinoma Subjects~     Undergoing Thermal Ablation~   "
103687|NCT02210169|"~     Babies aged 0 to 90 days with a suspected infection requiring treatment with vancomycin will~     be recruited. They will be randomised to receive vancomycin as an intermittent infusion (over~     1 hour) or as a continuous infusion (over 24 hours). The hypothesis is that administering~     vancomycin as a continuous infusion will result in improved attainment of target~     concentrations in blood at steady state (when the drug is in equilibrium) compared to~     intermittent infusion.~   "
103688|NCT02210156|"~     The purpose of this study is to determine whether the consumption of a nutritional supplement~     with micronutrients and herbal extracts has an effect on the incidence of acute respiratory~     infections in susceptible adults.~      Our hypothesis is that subjects who consume the nutritional supplement will have a lower~     incidence and duration of acute respiratory infections in comparison with the placebo group.~   "
103689|NCT02210143|"~     The aim of this study was to evaluate the reliability of the avascular root surface area as a~     prognostic identification criterion for gingival recessions and to compare the predictive~     value of the Miller classification and avascular root surface area (AERSA) calculation on the~     final root coverage outcomes.~   "
103712|NCT02209844|"~     To investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 44847~   "
103713|NCT02209831|"~     Study to assess the effect of gastric pH on the pharmacokinetics of BIRB 796 BS.~      Safety and tolerability were also assessed.~   "
103714|NCT02209818|"~     The aim of this study is to evaluate the effect of low level laser therapy (LLLT) on pain~     management in people commencing orthodontic treatment. The study design is a randomized~     controlled trial.~      Participants' pain will be dealt with by laser irradiation in one side of the jaw randomly,~     and the other side will be treated by a placebo procedure. Pain assessment will be measured~     using Visual Analog Scales (VAS).~      The hypothesis of this study is that laser irradiation decreases the amount of pain following~     the insertion of orthodontic separators.~   "
103715|NCT02209805|"~     Study to assess the safety and pharmacokinetics of BIRB 796 BS tablets administered as~     multiple daily doses at various dose levels.~   "
103721|NCT02209727|"~     Study to determine the maximum tolerated dose (MTD) and safety profile of a single-dose~     administration of sibrotuzumab (50 mg) conjugated to an increasing dose of 131 I isotope.~   "
103690|NCT02210130|"~     Cerebral small vessel disease (CSVD) is a major cause of cognitive impairment and disability~     in the general population, secondary to the accumulation of asymptomatic elementary lesions.~     CSVD is directly correlated with age and cardiovascular risk factors and therefore would be~     challenging in term of public health care in the future. While HIV patients share the same~     cardiovascular risk factors and they are often diagnosed with cognitive impairment and~     frailty, CSVD has not been yet described in this population.~      The global aim is to study and describe the CSVD in the HIV+ population by: (1) correlating~     the CSVD and the macro-vascular disease of the head and brain; (2) correlating the CSVD with~     the ocular (structural sentinel organ) and kidney (functional sentinel organ) micro-vascular~     disease.~      HIV+/CSVD+ patients will have a complementary work-up with conventional MRI/MRA, thorough~     vascular explorations, and neurologic examination to evaluate the severity of the CSVD, the~     macro-vascular disease and the cerebral atrophy. They will have a full ophthalmic examination~     and specific kidney explorations to evaluate the micro-vascular disease of this two sentinel~     organs. The same number of HIV+/CSVD- matched patients will have the same work-up.~      We are expecting to show the relationship between CSVD and cardiovascular risk factors in~     order to propose specific prevention. We will correlate the CSVD with the neurologic and~     cognitive function as it is already proved in the general population. We will correlate the~     CSVD with the ocular and kidney micro-vascular disease to propose fast, easy and cheap~     screening tools for the CSVD in the HIV+ population.~   "
103691|NCT02210117|"~     This is an investigational study. Nivolumab is FDA approved to treat metastatic melanoma or~     non-small cell lung cancer after the disease has gotten worse while receiving platinum-based~     chemotherapy. Ipilimumab is FDA approved to treat metastatic melanoma. The use of nivolumab~     and ipilimumab in this study is investigational.~      Bevacizumab is approved for certain types of kidney cancer and several other types of cancer,~     including breast, colon, and lung cancer. It is not FDA approved for the treatment of~     metastatic kidney cancer. The use of bevacizumab in this study is investigational. The study~     doctor can explain how the study drug(s) are designed to work.~      Up to 105 participants will take part in this study. All will be enrolled at MD Anderson.~   "
103692|NCT02210104|"~     The goal of this clinical research study is to learn about the safety of giving CD4+T cells~     with ipilimumab and cyclophosphamide.~      CD4+T cells are a type of white blood cell. Researchers grow the T cells in the laboratory,~     and they are designed to find cancer cells and may kill them.~   "
103693|NCT02210091|"~     The study purpose is:~        -  To assess the incidence of FVIII inhibitory antibodies during 6 months of twice weekly~          prophylactic treatment with BAX 855 or 50 exposure days (EDs), whichever occurs last.~        -  To compare pharmacokinetic (PK) parameters to ADVATE.~        -  To assess hemostatic efficacy in prophylaxis and the treatment of bleeding episodes.~        -  To evaluate safety and immunogenicity.~   "
103694|NCT02210078|"~     Any time the words you, your, I, or me appear, it is meant to apply to the potential~     participant.~      The goal of this clinical research study is to learn about the safety of giving cytotoxic T~     lymphocytes (CTLs) to patients who have had a stem cell transplant. Researchers also want to~     learn if these cells can help to control CMV.~      This is an investigational study. The use of CTLs to treat infection is not FDA approved or~     commercially available. CTLs are currently being used for research purposes only.~      Up to 30 participants will be enrolled in this study. All will take part at MD Anderson.~   "
103695|NCT02210065|"~     The goal of this clinical research study is to learn if giving cytotoxic T lymphocytes (CTLs)~     can help control CMV when it reactivates (becomes active again) in patients who receive an~     allogeneic stem cell transplant. Researchers also want to learn about the safety of giving~     CTLs to patients who have had a stem cell transplant.~   "
103696|NCT02210052|"~     The goal of the study was to determine if patients undergoing radiofrequency neurotomy (RFN)~     of lumbar facet joints that are adjacent to previously placed pedicle screws from a fusion,~     would lead to an increase in the temperature of the pedicle screws.~   "
103697|NCT02210039|"~     The study is being done to test the feasibility and tolerability of a SECM imaging probe in~     patients with Barrett's Esophagus (BE).~      A total of 12 subjects will undergo SECM probe imaging while they are under conscious~     sedation. Spiral SECM imaging will be performed continuously over a pre-determined length.~     Patients will later be asked for their feedback.~   "
103698|NCT02210026|"~     The investigators propose to test the hypothesis that Seattle bubble nasal continuous~     positive airway pressure (Seattle-PAP) supports respiratory physiology in very low birth~     weight (VLBW) infants more effectively than standard bubble nasal continuous positive airway~     pressure.~   "
103699|NCT02210013|"~     The investigators want to carry out a prospective study of 400 infertile Caucasian and Indian~     women who will undergo a controlled ovarian stimulation for in vitro fertilization (IVF). The~     investigators will collect data about ovarian reserve markers and also the results after~     ovarian stimulation in both ethnic groups.The aim is to identify differences in ovarian~     response after IVF stimulation between both groups.~   "
103700|NCT02210000|"~     This study is a randomized, double-blind, placebo controlled trial designed to confirm the~     symptomatic effects of camicinal treatment vs. placebo, on gastroparesis symptoms in type 1~     and 2 diabetic subjects with gastroparesis. The primary purpose of this study is to determine~     if a low-dose of camicinal (25 milligram[mg]) for 12 weeks of repeat administration improves~     gastroparesis symptoms as measured by the Gastrointestinal Cardinal Symptom Index - Daily~     Diary (GCSI-DD) in approximately 120 subjects with type 1 or 2 diabetes mellitus (DM) who~     have documented abnormally slow gastric emptying and have symptoms consistent with~     gastroparesis.~      Subjects will be randomized in a 1:1 ratio to receive either camicinal or placebo. The study~     will consist of a screening/baseline period of up to 35 days, a 12 week treatment period, a~     2-week post-treatment assessment of symptoms and a 14 day (+/- 2 days) post treatment safety~     follow-up visit.~   "
103701|NCT02209987|"~     This study will estimate the absolute bioavailability of subcutaneously injected GS-5745,~     characterize the safety, tolerability, and pharmacokinetics (PK) of GS-5745 after~     subcutaneous (SC) injection and intravenous (IV) administration, and evaluate the formation~     of anti-GS-5745 antibodies after SC and IV administration.~   "
103702|NCT02209974|"~     Chronic obstructive pulmonary disease (COPD) is characterized by pulmonary and systemic~     inflammation. The effect of inhaled corticosteroids (IC) on inflammation in COPD is~     controversial.~   "
103705|NCT02209935|"~     Background. Early rehabilitation programs (ERP) that include physical, occupational, and~     speech therapies lessens debilitation and promotes return to previous physical and cognitive~     functioning and have been successfully applied in adult intensive care units (ICUs). Despite~     the fact that critically ill children with acute brain injury (ABI) are at increased risk of~     life-long disability and stunted development, benefits of ERP for this group have not been~     studied and are not standard of care in pediatric ICUs.~      Objectives. The aims of this study are 1) To better understand current practices and barriers~     to use of these therapies and 2) To subsequently evaluate ERP vs. usual care in children with~     ABI in the ICU by randomizing children to these groups and measuring outcomes. We expect that~     ERP therapies are underutilized in the PICU and that outcomes in the ERP group will be~     superior compared to the usual care group.~      Methods. The first task of this research program is to survey healthcare professionals~     (physicians, nurses, allied health) and families of children in the ICU about their~     hospital's resources, current practices, and barriers to ERP. This survey will be distributed~     to the 78 sites affiliated with the Pediatric Acute Lung Injury and Sepsis Investigators~     (PALISI), a group of clinicians and researchers dedicated to improving child outcomes from~     critical illness. Next, we will enroll 175 children with ABI in a randomized, controlled~     trial of ERP versus usual care. Children enrolled in ERP will begin therapies by 48 hours of~     ICU admission and those in the usual care group will begin therapies when these services are~     ordered by treating physicians. Children aged 3-17 years with ABI expected to be admitted to~     the ICU > 48 hours due to trauma, infection, low oxygen, or low blood flow to the brain are~     eligible. Therapy interventions are individualized for the child's clinical status. The~     effectiveness of ERP will be measured using the Vineland Behavior Adaptive Scale (VABS)~     pre-ABI and 6 months post-ABI. This test, validated for children, assesses a child's physical~     and cognitive function as well as behavior. Other tests will be performed that assesses child~     and family quality of life and length of hospital admission. Our outcome tests were chosen~     because 1) They are the most important outcomes to families of children as surveyed in our~     ICU and 2) They are outcomes that can be influenced by ERP.~      Summary. This is the first and largest study designed to evaluate whether ERP improves~     outcomes for critically ill children with ABI. We anticipate that rehabilitation practices in~     ICUs will be unprotocolized and under-utilized. We expect that patients in the ERP group will~     have superior adaptive and quality of life outcomes, outcomes important to families, without~     increasing adverse events compared to patients in the usual care group.~   "
103706|NCT02209922|"~     Purpose:~      The incidence of stroke in low-to-middle income countries is increasing .Balance impairment~     and falling negatively impact function of stroke patients. Mobility is based on successful~     postural control and about 30% of individuals with stroke are unable to ambulate without~     assistance.Transcranial direct current stimulation (tDCS) is a new promising tool for motor~     recovery in neurological disease.This can be addressed through a tDCS intervention.~      Objective:The objectives of this study is to examine the efficacy of anodal tDCS combined~     with Biodex balance training on postural control in chronic stroke patients using laboratory~     and clinical assessments. The following essential treatment components; a) active tDCS~     stimulation paired with Biodex balance training, b)sham tDCS paired with Biodex balance~     training program.~      To identify combinations effects of tDCS stimulation plus balance training . Hypothesis:~     Anodal tDCS targeting leg motor area (CZ) for 5-days plus Biodex balance training, will~     significantly improve stroke clients' balance and functional mobility.~      Double blinded sham -controlled randomized tDCS stimulation Arms Assigned Interventions~      Experimental: Arm 1~      tDCS brain stimulation and simultaneous balance training~      Participants underwent Active tDCS brain stimulation (20 minutes) and simultaneous balance~     training(20 minutes) for 5 consecutive days.~      No Intervention: Arm 2 Sham tDCS brain stimulation (20 minutes) and simultaneous balance~     training~   "
103707|NCT02209909|"~     Platelet activation after off pump coronary artery bypass (OPCAB) surgery may affect thrombus~     formation. The purpose of this study is to assess the effects of preoperative continuation of~     aspirin on platelet activation after off pump coronary artery bypass surgery.~   "
103708|NCT02209896|"~     The BlueWind Reprieve system is a neurostimulator consisting of an Implant and external~     components.~      The system is intended for home care use. The chronic pain treatment is achieved by an~     electrical stimulation of peripheral nerve fibers. The stimulation is set so that it~     generates paresthesia in the stimulated area (e.g. foot), reducing the pain sensation and~     improving the quality of life for the patient.~   "
103709|NCT02209883|"~     COPD (Chronic obstructive disease ) is a condition of respiratory system failure seen~     occasionally in elderly patients of society. Sevofluorane is a safe, volatile anesthetic used~     considerably widely all over the world. Because respiratory functions and gas exchange became~     impaired in COPD patients, the respiratory system excretion/washout of inhalational~     anesthetic agents can be affected. In our study we aimed to investigate if there is a~     relation between sevofluorane's washout time and the degree of COPD.~   "
103710|NCT02209870|"~     The quality of cardiopulmonary resuscitation (CPR) has been identified as an important~     determinants for patient survival, yet many studies revealed poor CPR guidelines compliance~     in real-life practice for both health care providers and lay persons. Common shortcomings~     identified include an insufficient number of chest compression, too rapid lung inflations,~     and too much hands-off time. The poor quality of CPR is associated with lower survival rate.~     Besides, some other problems could be found during resuscitation, such as prolonged~     intubation time, delayed first shock delivery or unsteady drug delivery interval. These~     problems can't be blamed on the only person but the teamwork. Certain measurements could~     improve the performance of the resuscitation team, such as audio prompt or checklist.~      Methods proposed and improvised to improve the quality of CPR have included CPR assisted~     devices, automatic driven devices or audio prompt system. However, some of these methods are~     hardly incorporate with the original resuscitation process since it could be an extra~     workload. Therefore, the investigators try to provide an digitized checklist combined with~     visual and audio alarming system, which could not only minimize the workload of chart~     recording but also remind the team to perform essential procedures in time.~      Information gained from a video-recording evaluation system had been employed to improve the~     resuscitation skills. The improvement of resuscitation quality also could be found through~     video-recording after certain intervention. It can also avoid the interference of the~     resuscitation and find out other harmful factors to CPR quality.~   "
103711|NCT02209857|"~     Rationale:~      Prediction of prognosis in patients with breast cancer is important to determine the~     indication for adjuvant chemo-, endocrine- and immunotherapy. Apart from the~     clinicopathological parameters incorporated into the Adjuvant!Online predictive model, the~     validated 70-gene signature MammaPrint® is predictive of outcome too. MammaPrint® is advised~     in the current Dutch CBO guideline (2012) for hormone receptor positive, invasive ductal~     breast cancer in individual cases when there is 'doubt' about the indication for adjuvant~     chemotherapy based on traditional prognostic factors. In the present study MammaPrint® is~     used in this CBO 2012 guideline defined group of patients as an additional test for~     decision-making for adjuvant chemotherapy.~      Objective:~      To assess the impact of MammaPrint® on clinical decision making regarding the administration~     of adjuvant chemotherapy in the CBO 2012 guideline defined group of hormone receptor positive~     invasive ductal carcinoma patients when there is doubt about the indication for adjuvant~     chemotherapy based on traditional prognostic factors. The influence of various factors and~     the impact of MammaPrint® in predefined subgroups will be analyzed too. Data from a national~     registry regarding adjuvant systemic treatment in patients with similar clinicopathological~     characteristics in whom MammaPrint® was not used will be obtained to provide a control group.~      Hypothesis:~      In the group of patients where national guidelines advocate using systemic therapy but~     doctors are ambivalent in treating patients with adjuvant chemotherapy, it is hypothesized~     that using MammaPrint® as an additional test will change the indication for adjuvant therapy~     in a substantial proportion of patients resulting in at least 10% less patients who receive~     adjuvant chemotherapy. Thus, in the study group at least 10% less patients will receive~     chemotherapy when compared to a contemporary group of patients with similar~     clinicopathological characteristics but without using MammaPrint®~      Study population:~      Hormone receptor positive, invasive ductal breast cancer patients when there is doubt about~     the indication for adjuvant chemotherapy based on traditional prognostic factors.~      Study design:~      This is a prospective multicentre impact study.~   "
103726|NCT02209662|"~     Patients have a diabetic foot ulcer that is older than 4 weeks and has been treated with~     physician-selected standard of care treatment such as debridement, hydrogel or saline~     irrigation, primary dressing, and offloading will be randomized into one of two groups, the~     Standard of Care (SoC) or APIC-PRP + SoC. APIC-PRP has high level of platelets that produce~     growth factors that can help in wound healing.~   "
103727|NCT02209649|"~     Study to compare the bioavailability of Lacidipine and Telmisartan administered as fixed dose~     combination tablets with the separate Telmisartan and Lacidipine tablets.~   "
103728|NCT02209636|"~     The proposed research is a randomized-controlled trial to determine the effectiveness of~     reducing serum phosphorus using a phosphate binder, lanthanum carbonate, for improving the~     function of arteries in adults with moderate to severe chronic kidney disease (CKD). [COMIRB~     13-0328] Additionally, it will determine phosphorus balance among adults with CKD and whether~     there is a difference in phosphorus balance after three months of treatment with lanthanum~     carbonate. [COMIRB 15-0384]~   "
103729|NCT02209623|"~     The purpose of this observational study is to evaluate the safety of Tetanus Toxoid Reduced~     Diphtheria, Toxoid, and Acelluar Pertussis Vaccine (Tdap) in pregnant women at ≥ 20 weeks 0~     days gestation receiving Tdap as part of standard practice. Prior Tdap/Td/TT history will be~     verified by medical record review when possible. There will be an emphasis on enrolling women~     who have received Tdap before the current pregnancy, to the greatest extent possible.~     Non-pregnant women who are receiving their initial Tdap will also be recruited.~      Injection-site (local) and systemic reaction data will be assessed on the vaccination day and~     during the 7 days following vaccination using either identical web-based or paper diaries,~     depending on the preference of the study participant.~      Pregnant women will be followed until delivery with comprehensive obstetric and neonatal~     outcomes obtained from review of the electronic medical record.~   "
103730|NCT02209610|"~     A hallmark of patients with heart failure (HF) is premature fatigue which impairs their~     quality of life and depicts a major source of morbidity. Premature fatigue may be attributed~     to a) contraction-induced transient changes within muscles (i.e. peripheral fatigue) and/or~     b) failure of the central nervous system to 'drive' / activate locomotor muscles (i.e.~     central fatigue). Both determinants of fatigue can lead to a reduction in a muscle's force~     and power generating capacity and to a compromised ability to perform whole body activities~     (e.g. walking). Recent findings in health have documented that group III/IV afferent fibers~     from the working muscle play a critical role in the development of both components of~     fatigue. Specifically, group III/IV muscle afferents limit central motor drive (CMD) during~     exercise and thereby exaggerate the development of central fatigue. In contrast, muscle~     afferents optimize muscle O2 delivery through the precise regulation of circulation and~     ventilation during exercise and thereby attenuate the development of peripheral fatigue.~   "
103731|NCT02209597|"~     Determine bioequivalence between branded and generic bupropion extended release (XL) products~     (and between generic products) at steady state in patients with major depressive disorder.~   "
103732|NCT02209584|"~     This registry is intended to measure the impact of Prolaris® testing on therapeutic decisions~     when added to standard clinical-pathological parameters in men with newly diagnosed prostate~     cancer.~   "
103733|NCT02209571|"~     Exploratory comparative evaluation of exhaled breath composition in cystic fibrosis patients~     with age and gender-matched healthy adults in order to identify a disease-specific exhaled~     breath pattern as well as to gain insight into pathophysiological and microbial contributions~     to exhaled breath composition.~   "
103734|NCT02209558|"~     Sternal precautions are standard patient education protocol disseminated to post-operative~     open heart surgery patients . While this best practice safety measure is widely distributed~     to patients, the origin of said precautions is unknown. Statewide hospitals vary on their~     parameters for sternal precautions using a myriad of restrictions, i.e. weighted activities,~     biomechanical movements to be avoided. In addition, the medium in which sternal precautions~     are taught varies, thus complicating patient adherence to these vital post-operative~     measures.~      The primary objective of this study is to use a randomized pre-post test design to compare~     two different training procedures. One training group examines current standard of care~     (providing verbal instruction using teach back and written sternal precautions). The second~     training group provides subjects with visual depiction of sternal precautions, in addition to~     standard of care. The study will analyze 30 and 60 day readmission rates for aforementioned~     patients. Finally, the study will assess changes in behavior intentions from before training~     to after training in both groups via behavioral analysis survey consisting of 8 questions.~      Hypothesis 1: The investigators hypothesize that subjects provided with visual sternal~     precautions, in addition to standard of care, will have a lower 30 and 60 day readmission~     rate when compared to subjects in the standard of care group~      Hypothesis 2: The investigators hypothesize that changes in behavior intentions toward~     sternal precautions will be greater from before training to after training in the visual SPs~     in addition to standard of care group than the standard of care only group.~   "
103735|NCT02209545|"~     The aim of this research work is to assess the impact of a single preoperative dose of buccal~     misoprostol in reducing blood loss during abdominal fibroid surgery.~   "
103736|NCT02209532|"~     This is a randomized, prospective, open label, multicenter study to assess the safety and~     utility of PINPOINT® Near Infrared Fluorescence Imaging (PINPOINT) in identification of lymph~     nodes (LN) in patients with uterine and cervical malignancies who are undergoing LN mapping.~   "
103737|NCT02209519|"~     Male partners of womoen with recurrent bacteria vaginosis are randomized to treatment with~     metronidazole or placebo to compare the rates of recurrent BV in the women~   "
103738|NCT02209506|"~     The purpose of this study is to evaluate the safety and tolerability of single and multiple~     oral dosing of MLN3126 in ascending doses in healthy non-Japanese and Japanese participants.~   "
103771|NCT02209077|"~     This single-center, prospective, interventional clinical study is conducted to evaluate the~     repeatability and reproducibility of structural parameters of the optic nerve head, the~     peripapillary retinal nerve fiber layer, and the macula using the Heidelberg Spectralis OCT~     (Optical Coherence Tomography) device. Data obtained from healthy volunteers in this study~     are compared to those from a previous, larger healthy volunteer study that was conducted in~     the United States and Europe (S-2012-1), and data from glaucoma patients are compared to~     those from the healthy volunteers.~   "
103739|NCT02209493|"~     In light of the high CVD morbidity and mortality, promoting simple interventions to improve~     serum lipids and decrease oxidative stress are warranted to help prevent chronic diseases.~     Because of their fiber content, nopales (prickly pear cactus pads from the Opuntia species)~     are commonly regarded among Mexicans as a medicinal plant for glycemic and cholesterol~     control. However, the literature documenting their purported hypocholesterolemic potential is~     scarce. Given the unique composition and potential benefits of nopales, their use may be an~     ideal approach as an adjunct therapy for the reduction in cardiometabolic risk factors.~     Therefore, the aim of this study is to evaluate the efficacy of a 2-week intervention with~     nopales pads for the reduction of established CVD risk factors (serum lipids) in comparison~     to a control food with lower antioxidant and fiber content (cucumber) among adults with~     moderate hypercholesterolemia in a randomized controlled crossover trial. Because limited~     data exists on the effects of nopales supplementation on other factors associated with~     cardiometabolic risk, an exploratory assessment of how biomarkers of insulin sensitivity,~     inflammation (high sensitivity C-reactive protein [hsCRP]) and oxidative stress (LDL~     oxidizability and total antioxidant capacity) will also be conducted.~   "
103740|NCT02209480|"~     This study aimed to test the efficacy of five Alexander Technique lessons compared to the~     same period of heat pad application and guided imagery in patients with chronic non-specific~     neck pain.~   "
103741|NCT02209467|"~     The study hypothesis is that for people with moderate to severe multiple sclerosis postural~     balance and walking improve and the risk of accidental falls are reduced after participating~     in a specific training intervention of 7 weeks. The hypothesis is also the the effect remain~     a further 7 weeks post training.~      Multiple Sclerosis (MS) is disease affecting the central nervous system. Walking and postural~     balance are often affected early in the course of the disease. The risk of falls is large.~     Many persons with MS have decreased trunk stability compared to healthy persons . In an~     earlier study including people with mild to moderate MS we found that a period of core~     stability exercises reduced the risk of falls. In this study the training concept will be~     applied for persons with more severe walking limitations.~   "
103742|NCT02209454|"~     The purpose of this study is to compare the bioavailability of 25 mg DKP.TRIS given as an~     Enantyum® oral solution (Test formulation) and Keral® tablet (Reference formulation). In~     addition, this study intends to evaluate the safety and tolerability of Test and Reference~     formulations.~   "
103743|NCT02209441|"~     -  To determine the maximum-tolerated dose (MTD) and dose-limiting toxicity (DLT) of~          sorafenib in combination with FOLFOX4 (oxaliplatin/leucovorin/5-fluorouracil) as~          first-line treatment for advanced gastric cancer~        -  The design of the study incorporated a standard 3 + 3 dose escalation procedure to guide~          elevation of the sorafenib dosage to the next level~   "
103744|NCT02209428|"~     Low grade gliomas (LGGs) are the most common primary central nervous system malignancies.~     Brain surgeries with the most possible extent of resection are endeavored to achieve longer~     survivals in LGG patients. For patients with tumor located in eloquent areas so that gross~     total resection is not applicable, National Comprehensive Cancer Network (NCCN) 2013~     guidelines assigned both radiotherapy or chemotherapy as adjuvant treatments of low grade~     glioma following surgeries. Retrospective studies have suggested that temozolomide (an oral~     chemotherapeutics) chemotherapy have good effects on the control of tumor progression or~     recurrence in LGG patients after surgeries, especially in those with isocitrate dehydrogenase~     (IDH) gene mutations.~      Therefore, our prospective cohort study is to provide a higher level(IIb) of evidence for the~     correlation between IDH mutation and the responsiveness to up-front adjuvant metronomic~     temozolomide chemotherapy in young patients with LGG located in eloquent brain areas. And~     hopefully justify future RCTs with comparison between effects of adjuvant radiotherapy and~     chemotherapy in these patients.~   "
103745|NCT02209415|"~     Follow-up after successful operative treatment of cancer in the esophagus, stomach or~     pancreas in order to detect recurrent disease is a controversial topic.~      This is because the methods and the consequence of following these patients is unknown.~      Therefore the investigators will randomize these patients in to two groups:~        1. One group of patients will be offered visits with a specialist surgeon in a outpatient~          setting for a clinical evaluation every 3,6,9,12,18 and 24 months after surgery, as is~          the current standard at our department.~        2. The other group will be offered Endoscopic UltraSound, EUS, and PET/CT with the same~          intervals as the first group.~   "
103746|NCT02209402|"~     Chronic kidney disease (CKD) is a prevalent disorder and a major health concern.~     Cardiovascular disease is the most prevailing and life-threatening complication observed in~     patients with CKD. The diagnosis of CKD places a patient at the highest cardiovascular risk~     level irrespective of the stage of renal decline. Therefore, fatal cardiovascular events are~     more likely to occur than the evolution to final stages of kidney disease with the need for~     dialysis. Counter intuitively, treatment of classical cardiovascular risk factors does not~     affect cardiovascular prognosis in CKD, which suggests that the missing link between these~     two entities has not been elucidated yet.~      In the present project, the investigators focus on endothelial dysfunction in patients with~     CKD. Endothelial dysfunction precedes overt atherosclerotic changes by many years. In the~     absence of structural changes, endothelial dysfunction is still reversible, which offers~     therapeutic perspectives to tackle the progression towards atherosclerosis in an early stage.~      The purpose of this study is to determine whether an exercise training program is effective~     in ameliorating endothelial dysfunction in patients with chronic kidney disease.~   "
103747|NCT02209389|"~     The OctavaPink test is indicated as an adjunct to mammography for breast cancer screening in~     asymptomatic women for whom screening or diagnostic mammography findings are normal or benign~     (BIRADS assessment category 1 or 2) and breast tissue is dense (BIRADS composition/density 3~     or 4). The device is intended to increase breast cancer detection in the described patient~     population. Based upon the result of OctavaPink, the patient will be further evaluated by~     their physician.~   "
103748|NCT02209376|"~     An Open-Label Phase 1 Pilot Study to determine the safety and feasibility of CART-EGFRvIII~     (autologous T cells transduced with a lentiviral vector to express a chimeric antigen~     receptor specific for EGFRvIII) in the treatment of patients with EGFRvIII+ glioblastoma who~     have had their first recurrence as determined by standard imaging or have have residual~     disease after initial resection.~   "
103749|NCT02209363|"~     Cognitive dysfunction (impaired memory, thinking, etc) frequently occurs in Parkinson's~     disease (PD), often progresses to dementia, and profoundly affects quality of life.~     Obstructive sleep apnea (OSA) is a common disorder in the general population that is~     treatable with positive airway pressure (PAP) therapy. It is known to impair cognitive~     function, but whether treatment improves cognitive function is less clear. When already~     affected by a degenerative process like PD, the brain might be more vulnerable to the effects~     of OSA, and more responsive to OSA treatment. To date, OSA has not been recognized as a~     significant factor in PD. In preliminary work in PD patients, the investigators have found an~     association between OSA and poor cognition, and cognitive improvement with PAP therapy. The~     investigators now wish to more rigorously evaluate the effect of OSA treatment on cognitive~     function in PD in a randomized controlled trial. The investigators primary objective is to~     assess, in PD patients with OSA and cognitive deficit, the effect of OSA treatment on global~     cognitive function. The investigators will also assess other non-motor symptoms of PD,~     quality of life, and specific domains of neurocognitive function. PD patients will be~     recruited from the McGill Movement Disorders Clinic and other Quebec Parkinson Network~     Centres. Participants will need to have evidence of cognitive deficit and presence of OSA on~     screening diagnostic polysomnography (sleep study). Ninety subjects will be randomly assigned~     to PAP or nasal dilator strips. Detailed neuropsychological testing and other measurements~     (including quality of life) will be done at baseline, 3 months and 6 months. At the end of~     the study period, subjects will have polysomnography on their respective treatment to assess~     efficacy with respect to OSA treatment. This study may demonstrate that a non-pharmacologic~     intervention has the potential to have a marked beneficial impact on cognitive function and~     quality of life in a significant proportion of PD patients.~   "
103750|NCT02209350|"~     The aim of the study is to compare effectiveness and long-term results of aorta-femoral~     reconstructions and endovascular treatment in the patients with aorta-iliac lesions (TASC~     C,D).~   "
103751|NCT02209337|"~     A prospective, single arm, pre-market, multi-center clinical study to evaluate the safety and~     performance of the SRS (Lyra Medical) vaginal mesh in POP patients~   "
103752|NCT02209324|"~     A multicenter, open-label study is conducted to evaluate the efficacy and safety of ASP2151~     in patients with herpes simplex (recurrent labial/facial herpes and recurrent genital herpes~     and Kaposi varicelliform).~   "
103753|NCT02209311|"~     Autologous MMSCs will be isolated from oral mucosa biopsy sample and expanded in vitro.Tissue~     engineered construction will be created using synthetic tricalcium phosphate and autologous~     MMSCs. Patients will undergo sinus lift procedure with implantation of created~     tissue-engineered construction. This is a single arm study with no control. All patients~     receive cell therapy.~   "
103754|NCT02209298|"~     This observational study is intended to collect real-world (post-approval use) data regarding~     the clinical utility and performance of the Medtronic CoreValve® System for Transcatheter~     Aortic Valve Implantation (TAVI).~   "
103755|NCT02209285|"~     Patients with vascular and multiple chronic conditions (MCC) move between multiple care~     settings, and so they are at high risk of receiving fragmented care leading to increased risk~     for avoidable illness, death, and health care costs. Recent Canadian studies and reports~     identify significant gaps in the delivery of effective care to patients with multiple chronic~     conditions in community-based settings.~      The overall goal of the program is to promote successful management of chronic conditions,~     enhance quality of life, reduce the on-demand use of expensive health services and support~     primary caregivers (i.e. family or friends) who provide physical, emotional or financial care~     to an older adult with vascular conditions and MCC. This research program will leverage the~     tremendous potential to reduce the burden of vascular and vascular-related diseases by~     enhancing community-based prevention and chronic disease management.~      This pragmatic mixed-methods randomized controlled trial will evaluate the effectiveness of~     an interprofessional intervention on health-related quality of life (HRQOL), depression,~     anxiety, physical functioning, and the costs of use of health services for stroke survivors~     with MCC receiving home care and their family caregivers. The results will inform: (1) the~     development of national standards for community-based care for patients with multiple chronic~     conditions and (2) the development of a new and innovative community-based model for the~     management of multiple chronic conditions that can be scaled up and spread across Canada.~   "
103756|NCT02209272|"~     Local anesthesia is commonly used to reduce pain during joint injections, particularly for~     deep joints like the hip. Lidocaine is the most commonly used local anesthetic in most~     medical practices. It is well known that lidocaine infiltration itself is painful. Many~     strategies have been studied to minimize pain associated with lidocaine administration,~     including buffering, warming, and slowing infiltration rate. Bacteriostatic saline (BS) is an~     alternative local anesthetic that has been shown to be less painful when injected into~     subcutaneous tissues compared with lidocaine. However, BS use has not been widely implemented~     for local anesthesia, and it has not been studied in the context of joint injections. The~     purpose of this study is to compare infiltration pain and anesthetic efficacy between~     lidocaine and BS for ultrasound (US) guided intraarticular hip injections.~   "
103757|NCT02209259|"~     The investigators plan a prospective randomized study to see whether negative questions~     affect measures of mood, pain, or disability. A total of 175 patients will participate at~     Massachusetts General Hospital.~   "
103758|NCT02209246|"~     The investigators of this study would like to see whether providing feedback to patients~     regarding their illness behavior/coping strategies, using online questionnaires, improves~     patient-physician communication in orthopaedic surgery. The investigators aim to enroll 128~     patients.~   "
103759|NCT02209233|"~     The purpose of this study is to determine the effect that receiving massage therapy~     post-operatively has on reducing perceived anxiety and pain in urology patients. Secondarily,~     the result of massage on patient satisfaction, length of hospital stay, and narcotic use will~     also be studied.~   "
103770|NCT02209090|"~     Aim: To evaluate the efficiency of the modified Sims position versus maternal free positions~     in the rotation of persistent foetal occipito-posterior position intrapartum in pregnant~     women with epidural anaesthesia.~      Design: An open, randomised, controlled and parallel clinical trial will be conducted at the~     Delivery Room of the Area Materno-Infantil, Hospital Universitari Vall d'Hebron, Barcelona,~     Spain.~      Method: Fifty-six pregnant women with persistent foetal occipito-posterior position will be~     selected. Each woman will be assigned to a control or experimental group via an opaque~     envelope at a 1:1 ratio.~      The control group will deliver in free intrapartum positions, and the experimental group in a~     modified Sims position. Correction of foetal position is the key study variable, and delivery~     type the secondary variable. Statistical analyses will be made with the SPSS v.20 program.~   "
103772|NCT02209064|"~     Prospective non-randomized, single arm trial to further evaluate the safety and performance~     of EpiAccess, the study device, for gaining access to the normal, non-distended pericardial~     space during epicardial diagnostic or therapeutic (ablation) procedures.~   "
103760|NCT02209220|"~     Obstructive sleep apnea (OSA) is a syndrome characterized by intermittent dynamic obstruction~     of the upper airways that causes a fall in oxygen saturation, reflex sympathetic activation~     and sleep micro-arousals. In surgical patients, OSA is a well-known risk factor for~     perioperative complications. At Institut Universitaire de cardiologie et de Pneumologie de~     Quebec (IUCPQ), the investigators perform more than 450 bariatric surgeries per year.~     Consequently, the identification and management of OSA in this high-risk surgical population~     is an essential part of practice. Actual guidelines recommend that treatment for OSA be~     initiated before the surgical procedure. Presently, the first line treatment for OSA is~     continuous positive airway pressure (CPAP) therapy delivering a fixed pressure continuously~     to maintain the patency of the upper airways. However the compliance to this therapy is poor.~     An available alternative is automatic positive airway pressure (APAP) which delivers a~     variable amount of pressure to prevent reduction in airflow that accompanies upper airway~     obstruction. The APAP delivers the lowest pressure needed to prevent upper airways collapse.~     APAP significantly reduces the mean level of pressure delivered in comparison to conventional~     treatment. Theoretically, it seems logical that applying the lowest pressure necessary would~     allow a better device-patient synchrony and therefore improve patient's comfort.Recent trials~     comparing APAP and CPAP have shown that APAP is non-inferior to CPAP in controlling~     obstructive events. APAP would be a valuable alternative if it was not for its excess cost.~     However, APAP improves compliance to treatment in two types of population: poor compliant~     subjects and those needing high pressure levels. The investigators know that compliance to~     positive pressure is poor in patients without excessive daytime sleepiness, which represents~     the majority of patient waiting bariatric surgery. Moreover, in patients needing levels of~     pressure ≥ 10 water cm (cmH20), APAP improves treatment compliance, minimises side effects~     and improves quality of life. The review of 180 files of OSA patients treated by CPAP who had~     bariatric surgery in our center in 2012 demonstrated that the majority of patients needed~     high level pressure. These values suggest that APAP could improve treatment compliance in~     apneic patients waiting for bariatric surgery because they are usually poorly symptomatic and~     they generally require high positive pressure level.~   "
103761|NCT02209207|"~     This study will investigate the effects of interval walking training versus continuous~     walking training in patients with chronic obstructive pulmonary disease. Patients will be~     recruited during a 3-week inpatient pulmonary rehabilitation program and will be randomized~     to one of the two intervention groups. All walking training sessions will be performed on the~     same treadmill. Walking intensity in the continuous walking group will be 60 percent of the~     average speed of the 6-minute walking test. Patients in the interval training group will~     perform high intensity intervals at 120% of the 6-minute walking test speed for 60 seconds~     alternating with 60 seconds of rest. The total exercise duration will be progressively~     increased from 10 to 32 minutes.~   "
103762|NCT02209194|"~     The purpose of the study is to evaluate the clinical and technical success as well as safety~     and feasibility of the E-liac Stent Graft System used in endovascular treatment of uni- or~     bilateral aortoiliac or iliac aneurysm. Main study target is the exclusion of aneurysm with~     primary patency of the arteria iliaca interna and the arteria iliaca externa on iliac~     implantation side.~   "
103763|NCT02209181|"~     To assess the safety and effectiveness one dose of a new pain reliever medicine (JNJ-10450232~     at either the 250 or 1000 mg strength) compared with placebo (sugar pill) or acetaminophen~     1000 mg after surgical removal of third molars. The primary endpoint will evaluate pain~     relief effectiveness up to 6 hours after administration of the study drug.~   "
103764|NCT02209168|"~     The aim of this study is to confirm the difference in ovarian reserve markers and serum~     vitamine D levels between infertile indian, arabian and caucasian population.~   "
103765|NCT02209155|"~     This is a double-blinded, randomized, parallel, placebo-controlled phase 2 study to evaluate~     the safety and efficacy of R-verapamil in the prophylaxis of episodic cluster headache.~   "
103766|NCT02209142|"~     Depression is a leading cause of disability worldwide, affecting nearly 16% of the general~     population. Its physiopathology remains unclear. Based on gene-environment studies and~     epigenetic studies, a main hypothesis proposed that the major depressive episode (MDE)~     results from the convergence of multiple factors including biological factors such as~     multi-genic vulnerability, hormonal and immunological variations as well as environmental~     factors. As a consequence, mRNA could define a biological signature of the MDE.~   "
103767|NCT02209129|"~     Patients with a higher breast cancer risk (higher than 17% according to the IBIS calculation)~     will receive a 2D digital mammography together with a 3D tomosynthesis (so called combo tomo)~     of both breasts in two views in order to investigate the additional value of tomosynthesis in~     the diagnosis of breast cancer.~   "
103768|NCT02209116|"~     Attention Deficit/Hyperactivity Disorder (ADHD)is one of the most common mental health~     disorders of childhood. Children with ADHD often have poor attention, are restless and~     hyperactive and show impulsive behaviour.~      It is important to detect ADHD so young people can have access to appropriate clinical~     interventions.~      One of the most common ways ADHD is assessed is through the clinician's opinion; however,~     this can vary between clinicians and is thought to be one reason why ADHD may be~     mis-diagnosed. Using a more objective computer tasks may help improve our understanding of~     ADHD. One computer task is the QbTest.~      The test presents different symbols to the child, and the child has to respond by pressing a~     button only when a target symbol appears. The test measures the child's attention,~     impulsivity and movement whilst doing this task.~      Although the test is thought to be a valid measure, more research needs to be conducted on~     this measure to see whether it helps clinicians decision making.~      To see whether this test helps clinicians make a diagnosis of ADHD and helps with medication~     decisions, children and young people will be asked to complete the task as part of their~     initial assessment for ADHD. Half the participants and their clinician will have access to~     the QbTest result; the other half will not have access to the QbTest result until the end of~     the study.~      Participant's parents, teachers and the clinician will also be asked to complete some~     questionnaires about the child's symptoms and behaviour. If the child is diagnosed with ADHD~     and is given medication they will be asked to complete the task again on medication. The same~     set of questionnaires will be completed by the parents/teachers/clinicians.~      The entire sample will be followed up at 6 months and asked to complete the questionnaires.~   "
103769|NCT02209103|"~     This study aims to determine whether a citrus flavonoid or a citrus flavonoid formulation can~     improve objective sleep duration and/or quality, and/or improve perceived sleep quality and~     feelings of rest.~      Participants will complete a total of 9 test nights, which consist of sleeping with the sleep~     monitoring system after ingestion of the test product or a placebo, and filling out~     sleep-related questionnaires.~      The study has a crossover design, meaning that all participants receive all three~     interventions (citrus flavonoid, citrus flavonoid formulation, placebo) three times, in a~     randomized order.~   "
103773|NCT02209051|"~     The primary goal of the study is to demonstrate the increased rate of complete wound closure~     by AMNIOEXCEL® compared to routine care in patients with chronic diabetic foot ulcers~   "
103774|NCT02209038|"~     There is a large gap between the care seriously ill patients want and the care they receive.~     Advance directives (ADs) offer an opportunity for patients to express specific end-of-life~     preferences to avoid unwanted care. As promising as ADs may be for improving the quality of~     care near the end of life, rates of AD completion remain low and previous efforts to~     encourage their completion have had limited success. Principles of behavioral economics, such~     as the effects of defaults and other framing effects, may offer a novel approach to bridge~     the gap in end-of-life care. The goal of this study is to test whether the framing effect of~     expanding choice sets can increase the completion of and specification of choices within~     advance directives.~   "
103775|NCT02209025|"~     Rationale: Despite successful efforts to lower atherogenic serum low-density lipoprotein~     (LDL) cholesterol concentrations, a substantial residual cardiovascular risk remains. An~     additive strategy to further lower this residual risk may be via raising high-density~     lipoprotein (HDL) concentrations, and in particular those of its major protein constituent~     apolipoprotein A-I (apoA-I). Based on several studies, theobromine may be a promising~     candidate in this respect. Recently, theobromine was shown to increase serum HDL cholesterol~     (HDL-C) concentrations by 0.16 mmol/L or 10% and apoA-I levels with 8%. The question is~     whether this increase in HDL-C and apoA-I concentrations observed translates into an improved~     functionality of the blood vessels. Effects of theobromine on vascular function have never~     been evaluated in a placebo controlled human intervention study.~      Objective: The primary objective is to evaluate the long-term effects of theobromine on~     vascular function in healthy subjects with a slightly lowered HDL-C in the fasting and the~     postprandial state. The second primary objective is to evaluate the long-term effects of~     theobromine on intestinal apoA-I mRNA and protein expression levels in healthy subjects with~     a slightly lowered HDL-C in the fasting and the postprandial state.~      Secondary objectives are to study the long-term effects of theobromine on (1) fasting serum~     HDL-C concentrations, (2) cholesterol efflux capacity and (3) postprandial lipid and glucose~     metabolism.~      Study design: A randomized, double-blind, placebo controlled cross-over design. The total~     study duration will be 12 weeks, consisting of a 4 week experimental period, a 4 week~     wash-out, and a 4 week control period. At the end of the experimental and control periods, a~     postprandial test will take place.~      Study population: Forty-eight healthy men aged 45-70 years and women aged 50-70 years, with~     slightly lowered HDL-C concentrations (men <1.3 mmol/L and women <1.5 mmol/L).~      Intervention: During the experimental period, subjects will consume daily at breakfast an~     drink containing 500 mg theobromine. During the placebo period, the subjects will consume~     daily at breakfast the same drink without theobromine. During the wash-out period, they will~     not consume any of the drinks.~      Main study parameters/endpoints: Measurements will be performed at the end of both 4-week~     intervention periods. The effects of theobromine will be calculated as the absolute~     differences between values obtained at the end of each period. The primary endpoint is the~     change in vascular function defined as % change in flow-mediated dilation (FMD) after intake~     of a daily stressor, a milkshake providing all the three different macronutrients. The second~     primary endpoint is the change in apoA-I mRNA and protein expression on the end of each~     period 5 hours after intake of the milkshake.~   "
103776|NCT02209012|"~     The purpose of this study is to determine the long-term safety and efficacy of Levulan PDT in~     subjects with multiple actinic keratosis of the upper extremities who received treatment as~     part of the DUSA CP0108 study.~   "
103777|NCT02208999|"~     Assessing the long-term efficacy, complications, revision rates and final explantation of the~     device~   "
103778|NCT02208986|"~     The aim of this randomized single center study is to explore the most optimal dose of GnRHa~     used for triggering of final oocyte maturation in IVF. The study group will consist of oocyte~     donors who have GnRHa trigger as a standard trigger concept.~      Hypothesis: In an Asian oocyte donor population, the use of 0.2 mg, 0.3mg or 0.4 mg of GnRHa~     will lead to the retrieval of comparable numbers of mature oocytes (MII) and good quality~     embryos. Moreover, the reproductive outcome in the recipients will be similar regardless of~     the dose of GnRHa used for trigger.~   "
103779|NCT02208973|"~     To assess the safety and tolerability of five doses of PBF-680 (5 mg, 10 mg, 20 mg, 40 mg and~     60mg) after repeated (8 days) single daily oral dose administration in young male and female~     healthy subjects.~   "
103780|NCT02208960|"~     Each year, more than 3 million neonatal deaths occur worldwide and greater than 200 million~     children under the age of 5, almost all in low- and middle-income countries, are not~     fulfilling their developmental potential. The development of the growing brain can be~     affected through multiple mechanisms including the same insults that are major causes of~     mortality, namely hypothermia and infection. The first month of life is a crucial period in~     neurodevelopment (ND). In this study, the investigators propose the home-based use of an~     integrated evidence-based toolkit to improve health status, reduce the incidence of neonatal~     insults that may affect brain development, decrease neonatal mortality rate (NMR), and~     provide early identification of danger signs. The investigators hypothesize that use of the~     neonatal toolkit will result in an improvement of at least one standard deviation in~     neurodevelopment as measured at 12 months of age by the Protocol for Child Monitoring Infant~     and Toddler (PCM-IT) version.~   "
103781|NCT02208947|"~     The specific aims of the project are: 1) to test the effectiveness of consumer-directed~     financial incentives paired with provider-directed financial incentives, compared to~     provider-directed financial incentives alone, for increasing advance care planning (ACP)~     among Medicaid beneficiaries; and 2) to assess perceptions regarding the appropriateness of~     consumer-directed financial incentives for ACP among study participants. The investigators~     hypothesize that consumer-directed financial incentives will result in a 15-percentage point~     absolute increase in the proportion of subjects completing ACP. The investigators do not~     advance hypotheses about the qualitative component.~   "
103782|NCT02208934|"~     Study To Assess the Safety and Tolerability of Single Ascending Oral Doses of PBF-999 ( 5 mg,~     10 mg, 20 mg and 40 mg ) in Healthy Young Male Volunteers~   "
103783|NCT02208921|"~     This non-interventional, multi-centric, cross-sectional study is aimed to determine the~     prevalence of Chronic Kidney Disease in Indian patients with Type 2 Diabetes (T2DM). 3000~     patients will be enrolled from 30 investigative sites all over the country. Each~     investigative site will be expected to enrol 100 subjects. All the procedures will be~     completed in a single day.~   "
103784|NCT02208908|"~     The purpose of this study is to measure the impact of training on the practical assessment~     and management of the oral status of patients hospitalized in palliative situation.~   "
103785|NCT02208895|"~     Pleural fluid glucose levels measured with bed-side point of care methods such as finger~     stick glucometers and I-STAT device correlate with the traditional in-lab testing methods.~   "
103786|NCT02208882|"~     The purpose of this study is to assess the safety, tolerability and effect on Midazolam~     pharmacokinetics of multiple oral doses of BMS-986120 in healthy subjects.~   "
103826|NCT02208362|"~     This phase I trial studies the side effects and best dose of genetically modified T-cell~     immunotherapy in treating patients with malignant glioma that has come back (recurrent) or~     has not responded to therapy (refractory). A T cell is a type of immune cell that can~     recognize and kill abnormal cells in the body. T cells are taken from the patient's blood and~     a modified gene is placed into them in the laboratory and this may help them recognize and~     kill glioma cells. Genetically modified T-cells may also help the body build an immune~     response against the tumor cells.~      Funding Source - FDA OOPD~   "
103787|NCT02208869|"~     True prevalence of FH in the Russian Federation is unknown which leads to low percentage of~     diagnosed and treated cases. Research is needed to determine the prevalence of FH, specific~     diagnostic algorithms and optimal treatment strategies. The main aim of the present study is~     to evaluate the extent to which FH is underdiagnosed and undertreated in the Russian~     Federation for reduction of cardiovascular risk related to atherosclerosis in the country.~      As a first step, total cholesterol (TC) and low-density lipoprotein (LDL-C) levels will be~     determined in a random sample from Moscow population (n=18000). It is expected that TC ≥ 7.5~     mmol/L will be detected in 10% of cohort. During 2014, approximately 500 patients will pass~     through non-invasive clinical examination at the Russian Cardiology Research and Production~     Center, including patient demographics, past medical history, family history of~     hypercholesterolemia, physical findings, current lipid-lowering therapies, blood tests,~     genetic analysis, echocardiography, carotid duplex ultrasound and exercise SPECT imaging in~     selected cases. On the basis of the Moscow Program four major Federal Medical Centers will be~     involved, and FH Registry will be created as a national, multi-center initiative to screen FH~     patients, control their diagnosis and management, and track clinical-reported outcomes over~     time.~      Establishment of National Guidelines for the diagnosis and treatment of FH on the basis of~     these data and implementation those into clinical practice in different regions of Russia~     will allow improving patient care. As an expected outcome, this program will raise awareness~     and increase appropriate assessment and treatment of FH patients in Russia, leading to a~     timely detection of the disease and therapy initiation.~   "
103788|NCT02208856|"~     To assess safety, pharmacokinetics and pharmacodynamics of BIRB 796 BS in escalating single~     doses, with and without a 64 g fat breakfast at one selected dose.~   "
103789|NCT02208843|"~     The objectives of this single-arm, open-label trial are to assess the efficacy and safety of~     afatinib as second line treatment for patients with locally advanced or metastatic non-small~     cell lung cancer (NSCLC) harbouring a common EGFR mutation who have failed first-line~     platinum-based chemotherapy and to demonstrate that the efficacy and safety are comparable to~     the results seen in previous trials.~   "
103790|NCT02208830|"~     The hypothesis of this study is that the group of patients who will carry out the~     rehabilitation program associated with respiratory therapy will have higher benefits in~     physical function, peripheral muscle strength and quality of life compared to the group that~     will only perform chest physiotherapy. Additionally, there will be a negative correlation~     between inflammatory mediators and measures of physical ability as well as the magnitude of~     improvement is lower after treatment in patients with higher baseline levels of inflammation.~   "
103791|NCT02208817|"~     2 recent national reports 'Why Children Die' and 'Are we there yet?'identified deficiencies~     in recognising and managing sick children. Key recommendations from both reviews included the~     development and adoption of 'track and trigger' or a paediatric early warning score (PEWS) to~     better identify the sick or deteriorating child. PEWS tools offer the potential to identify~     and respond sooner to clinical deterioration. Capillary refill time (CRT) is a measure of~     skin blood flow and is a vital part of many early warning and resuscitation scores. It is a~     sensitive marker of infection and dehydration in children. However, due to how it is~     performed and interpreted CRT is prone to marked variability between observers.~      We have Medical Research Council (MRC) funding to develop an automated capillary refill~     device and user interface to provide a paediatric continuous early warning (PaedCEW)~     monitoring system. The PaedCEW system would complement and support current clinical practice~     and aim to address the difficulties of recognising ill children.~      We aim to recruit 20 ill children on the Paediatric Intensive Care Unit (PICU) with 2 matched~     controls without significant illness from the Nottingham Children's Hospital. The 20 ill~     children will have their CRT (and PaedCEW score) monitored before, during and after admission~     to PICU. This will allow correlation with invasive (BP, central venous oxygen saturations,~     lactate) and noninvasive (CRT, heart rate, cardiac output) measures of cardiovascular status~     during periods of stability and compromise. Matched controls will be monitored for around 24~     hours. This pilot study will allow development of our system.~      This is a proof of concept study. This study aims to demonstrate a novel device for measuring~     CRT. Its correlation with noninvasive measures of cardiovascular status will enable a~     pragmatic comparison with current clinical practice. In addition, correlation with invasive~     measures of cardiovascular status will enable us to calculate sensitivity, specificity,~     negative predictive value (NPV) and positive predictive value (PPV).~   "
103792|NCT02208804|"~     The objective of the SIM trial is to investigate whether using the Surefire Infusion System~     during holmium-166 radioembolization increases the posttreatment tumor to non-tumor activity~     concentration ratio, compared with using a standard end-hole microcatheter.~   "
103793|NCT02208791|"~     The purpose of this study is to determine the effects of sirolimus in the phenotype of~     peripheral blood T and B lymphocytes regarding their naïve, memory, effector end regulatory~     phenotype and in the development of anti-HLA antibodies among kidney transplant recipients~     with high immunological risk for graft rejection.~   "
103794|NCT02208778|"~     Osteoarthritis (OA) is a degenerative joint disease and is the most common form of arthritis.~     Pain reduction and functional recovery are the key elements of the clinical management of OA.~     Current treatment guidelines recommend a combination of pharmacological and~     non-pharmacological treatments. However, these are not always effective, with nearly 20% of~     patients not responding to any standard therapy, including joint replacement.~      The mechanisms of pain relief are not well understood and are complicated by the remarkably~     large placebo effect, and inter-individual variation. There is no objective criteria for~     predicting whether a patient will respond to a given treatment~      Duloxetine, an antidepressant drug, has proven effectiveness in various chronic pain~     syndromes including knee OA. The effect is however limited and only clinically relevant in~     around half of the trial patients. Importantly, it is currently unclear how and in whom~     duloxetine alleviates chronic pain.~      Advanced MRI techniques use strong magnetic fields and radio frequency signals to generate~     metabolic, anatomical and functional brain images (fMRI).~      Remifentanil is a potent analgesic agent whose analgesic effect has been well characterised~     in healthy volunteers, including fMRI studies showing modulation of activation of regions in~     the brain related to pain processing. Nevertheless, the neural correlates of remifentanil~     effects have not yet been investigated in chronic pain patients.~      The aim of this research is to use a combination of multimodal MRI, genetic and psychometric~     assessments to identify the mechanisms of pain relief in knee OA patients, following~     treatments with duloxetine and remifentanil, in a placebo controlled condition. With this we~     also aim to identify genetic, anatomical and brain activity predictors of treatment outcomes.~      The main hypotheses are:~        -  Analgesic response to duloxetine treatment can be predicted using a range of baseline~          brain imaging markers and QST.~        -  Analgesic response to duloxetine is mediated by modulation of neural networks~          underpinning emotional control.~        -  Duloxetine-induced changes in brain activation differ between responders and~          non-responders.~      This study is expected to last for two years. It is funded by Arthritis Research United~     Kingdom and forms part of a wider scientific investigation, using translational~     methodologies, to enhance the understanding of arthritis pain and to improve its treatment.~   "
103827|NCT02208349|"~     The goal of this study is to compare the first pass success rate of intubation between video~     assisted intubation and traditional direct visualization intubation in the field by Emergency~     Medical Service (EMS) professionals~   "
103909|NCT02207270|"~     The purpose of this study is to determine whether the total costs of care associated with~     uncomplicated elective or low-risk urgent percutaneous coronary intervention (PCI) through~     30-day follow up are lower among patients who are randomly assigned to same day discharge~     (SDD) or overnight hospital stay (ON).~   "
103795|NCT02208765|"~     Endothelial dysfunction has been demonstrated to be an early marker of coronary artery~     disease (CAD). On the other hand, myocardial perfusion single photon emission computed~     tomography (MP-SPECT) is a widely used technique for evaluation of patients with suspected or~     known CAD.~      Preliminary data suggest that myocardial perfusion heterogeneity (a potential surrogate~     marker of endothelial dysfunction) can be assessed on conventional MP-SPECT, but its additive~     and independent prognostic value over the presence of myocardial ischemia remain unknown.~      Accordingly, the purpose of this study is to evaluate the prognostic value of myocardial~     perfusion heterogeneity assessed by a new automatized image processing method applied to~     routine MP-SPECT.~      The main hypothesis is that the presence of myocardial perfusion heterogeneity is predictive~     of 2-year cardiovascular events in patients referred to the Nuclear Cardiology Department for~     routine evaluation of known or suspected CAD.~   "
103796|NCT02208752|"~     This is a randomised controlled study involving a group of 20 patients- 10 patients in a~     control group, 10 patients in treatment group. The treatment group consists of exercises with~     theraband for the shoulder and exercises of motor control of the scapula. The purpose of the~     study is to measure the effects of a pre-operative physiotherapy program for patients awaitng~     for rotator cuff surgery, The duration of the pilot project is 4 weeks.~   "
103797|NCT02208739|"~     Periodontitis, a bacterial dental biofilm based infectious disease, is a chronic inflammatory~     disease of the periodontium which results in irreversible destruction of supporting~     structures of the teeth such as periodontal ligaments, connective tissues, cementum and~     alveolar bone. More than 700 species of bacteria are estimated to be found in the~     sub-gingival dental biofilm in which periodontopathogens are found to be responsible in~     initiating periodontal disease. Chronic periodontitis, although termed as 'chronic', starts~     as an acute inflammation. Low levels of bacteremia and endotoxins provides a stimulus for the~     systemic inflammatory response. In periodontitis, the interaction of lipopolysaccharide (LPS)~     from gram-negative bacteria with host cells initiates the secretion of cytokines and the~     expression of cell adhesion molecules in gingival tissue which leads to loss of alveolar bone~     and connective tissues supporting the teeth.~      In the management of chronic periodontitis, non surgical periodontal therapy (NSPT) which~     includes oral hygiene instruction (OHI), scaling and root planing, is administered to improve~     clinical parameters as well as controlling the bacterial count responsible in initiating the~     disease and the resultant inflammatory response. Success of the treatment can be analyzed~     when the clinical parameters, counts of the microbes is reduced and inflammatory response is~     controlled. Studies which have evaluated the microbiological and immunological response~     following NSPT clearly demonstrates an improvement in clinical parameters, reduction in~     inflammatory mediators present as well as a decrease in microbial count.~      OHI which includes tooth brushing and inter-dental cleaning is found beneficial in removing~     microbial plaque, thus, preventing periodontal diseases such as gingivitis and periodontitis.~     Studies have evaluated the role of OHI on clinical and immunological parameters and~     microbiological profiles of periodontal maintenance subjects, while none of them evaluated~     its role alone in the management of chronic periodontitis subjects. Therefore, the purpose of~     the following investigation was to compare the changes in the clinical parameters,~     inflammatory mediators as well as level and frequency of detection of periodontopathogens~     that take place after 3-months of NSPT versus OHI and to evaluate if clinical parameters have~     an effect on these inflammatory mediators and microbiological changes.~   "
103798|NCT02208726|"~     Increased levels of stress and anxiety are experienced by many students. Stress can have a~     negative influence on academic outcome and performance, as well as on the student's mental~     health. Conventional treatment options for anxiety include counseling, as well as anxiolytics~     and antidepressants, which may have various adverse effects. Picricum acidum and Phosphoricum~     acidum are homeopathic remedies that may be helpful in alleviating anxiety in students;~     however there has been no research done to date to show their efficacy for this condition.~      The aim of this study is to determine the effect of Picricum acidum and Phosphoricum acidum~     Homaccord on perceived levels of anxiety in university students, by means of the~     State-Trait-Anxiety-Inventory and Anxiety Symptom Score Card.~   "
103799|NCT02208713|"~     Facioscapulohumeral Dystrophy is a Autosomal dominant inherited dystrophy with the prevalence~     of 1:20,000 and it is the third most common dystrophy after the dystrophinopathies and~     myotonic dystrophy. The symptoms including: Pain, facial weakness, scapular fixator, humeral,~     truncal, pelvic girdle and lower-extremity weakness, High frequency hearing loss, Retinal~     telangiectasia . The existing treatments are not effective so, cell therapy is a new hope to~     improve patients' quality of life. Therefore, We design this clinical trial to evaluate the~     safety and feasibility of stem cell transplantation.~   "
103800|NCT02208700|"~     Patients with mechanical ventilation have shown improved weaning rates when enteral tube~     feeding high in EPA, GLA and antioxidants were fed to patients in the critical care setting.~      LTAC Patients on chronic mechanical ventilation will have decreased days an mechanical~     ventilation, decreased mortality rates and decreased organ failure when fed an enteral~     product high in EPA, GLA and antioxidants compared to an isotonic high fiber enteral~     nutrition product.~   "
103801|NCT02208687|"~     Fatigue is present in at least 60% of the patients with a muscle disease and can be the most~     disabling symptom. In combination with other impairments, this often results in low levels of~     physical activity and decreased social participation, leading to large societal costs.~     Energetic is a self-management group program aimed at improving participation and physical~     endurance in these patients. Our hypothesis is that Energetic results in improved~     participation and improved physical endurance, less experienced fatigue and better quality of~     life compared to usual care, without increasing health care costs.~   "
103802|NCT02208674|"~     Chronic kidney disease (CKD) is highly prevalent and associated with significantly increased~     risk of cardiovascular morbidity and end-stage renal disease. Evidence from randomized~     clinical trials suggests that treating urinary albumin excretion (UAE), dyslipidemia, and~     hypertension will reduce these risks. Unfortunately, less than 30% of the CKD population is~     screened and treated according to recommended guidelines. Using a cluster-randomized,~     controlled design and clinic-embedded pharmacists, this pilot pragmatic trial will randomize~     6 Geisinger primary care clinics (72 patients) to usual care (group 1) or a~     pharmacist-directed CKD Action Plan (group 2). Determining the impact of the CKD Action~     Plan on screening and treatment guideline adherence is the primary goal of this pilot study.~   "
103823|NCT02208401|"~     Different modalities are employed to remove small colonic polyps which potentially harbour a~     cancer risk. But, they can all vary in their completeness of removal, safety and the~     histological quality and the gold standard technique has yet to be defined. A novel suction~     pseudopolyp technique has been described by Patullo et al and in their prospective study, 126~     polyps measuring less than 10mm flat or sessile were removed by this method with 100%~     complete endoscopic resection and without any immediate or delayed complications. The aim of~     the investigators study is to compare this technique with the standard cold snare technique.~     Patients attending for a routine colonoscopy and found to have polyps measuring 37mm in size~     will be eligible and they will be randomised to the polypectomy technique. Patient~     demographics and polyp characteristics will be recorded. The primary outcome measured will be~     the macroscopic resection rate. The secondary outcome measures are abdominal pain,~     tenderness, bleeding and fever.~   "
103803|NCT02208661|"~     Mucopolysaccharidosis IV, also known as MPS IV or Morquio disease, is a rare autosomal~     recessive genetic lysosomal storage disorder. Research thus far regarding Morquio, has~     primarily focused on the physical aspects of the various diseases. Less attention has been~     paid to the psychological toll of these diseases, whether they are direct symptoms or~     reactions to living with a chronic progressive disease.~      Prior to 2013, there was neither a cure nor treatment (other than palliative) for Morquio~     disease. In the latter half of 2013, ERT became available to the broader population of~     patients with Morquio A disease through BioMarin's Expanded Access Program.~      In a previous study, entitled Psychological Concomitants of Morquio syndrome the present~     investigator enrolled 20 adult subjects with Morquio into a pilot study to estimate a~     baseline incidence of psychological symptoms and overall quality of life. Subjects were all~     over the age of 18. Data from this study were published in 2015.~      The present study extends this research into psychological health with Morquio via a~     comparison of psychological issues and quality of life before and after treatment (i.e. ERT).~     As ERT does not cross the blood-brain barrier, it would be unlikely to improve organic~     psychological symptoms, but may improve any reactive psychological symptoms caused by living~     over time with this chronic progressive genetic disease.~      The present study thus seeks to follow adult patients with Morquio A disease as they begin~     ERT and track their psychological health every 6 months for a duration of 2 years. Adult~     patients with Morquio disease are invited to participate. Subjects will complete three~     different self-report questionnaires, the Achenbach System of Empirically Based Assessment~     (ASEBA) Adult Self-Report (ASR), the Short Form 36-item Health Questionnaire (SF-36), and the~     Brief Pain Inventory (BPI). Group aggregate data will be reported; individual questionnaire~     content and results will be held confidential, except as in accordance with Georgia law~     relating to reporting of child or elder abuse, suicidal and/or homicidal intent.~   "
103804|NCT02208648|"~     The study will investigate whether the presence of coronary artery calcium as demonstrated on~     pre-operative, thoracic staging Computed Tomography (CT) is an independent risk factor for 90~     day mortality in patients undergoing major abdominal surgery.~      The study research question: Do higher levels of coronary calcification correlate to an~     increased risk of post-operative mortality in patients undergoing major abdominal surgery?~   "
103805|NCT02208635|"~     The objective of this study is to compare the quantity of Zn absorbed from an accurately~     weighed quantity (~100 g) of minimally milled control maize (~15 µg Zn/g maize), from~     biofortified maize (~30 µg Zn/g) and from the same control maize that has been fortified~     (total level of ~60 µg Zn/g) when fed to young children age 24-36 months whose major habitual~     food staple is maize.~   "
103806|NCT02208622|"~     Bioavailability of iron and zinc from habitual plant-based diets consumed by young children~     in Mexico is low due to the high phytate content. Whey protein has been found to increase~     zinc absorption, thus, providing a whey based supplement with micronutrients may be an~     effective strategy to increase iron and zinc bioavailability from plant-based foods and~     alleviate iron and zinc deficiencies. The investigators compared absorption of zinc and iron~     in children receiving diets with and without whey protein supplements (WPS).~   "
103807|NCT02208609|"~     Young children in Guatemala are at risk for nutrient deficiencies due to plant-based diets~     and poor sanitation. Stunting, frequent diarrhea, and respiratory infections are common.~     Supplementation of Zn to children during diarrhea episodes has been shown to diminish~     duration and severity of illness. Poor Zn absorption due to high fiber and phytate in this~     diet might play a role in these processes. Supplementation of this micronutrient in the diet~     might be beneficial. The investigators will compare absorption of Zn from white maize~     tortillas enriched with 20% amaranth to traditional white corn tortillas in preschool~     children in Guatemala.~   "
103808|NCT02208596|"~     To explore the feasibility of different doses of etomidate admixed with propofol in induced~     abortion: a randomized, double blind controlled trial.~   "
103809|NCT02208583|"~     To explore the molecular phenotypic changes and personalized treatment in~     castration-resistant prostate cancer.~   "
103810|NCT02208570|"~     The purpose of this study is to find out the predictability of the pulse pressure variation~     during spontaneous ventilation on the incidence of hypotension during induction of~     anesthesia.~   "
103811|NCT02208557|"~     Background: Development of an incisional hernia is one of the most frequent complications of~     midline laparotomies requiring reoperation. This paper presents the rationale, design, and~     study protocol for a randomized controlled trial, the aim of which was to evaluate the~     efficacy and safety of prophylactically placing a bioabsorbable synthetic mesh for~     reinforcement of a midline fascial closure.~      Methods: The PREBIOUS trial (PREventive midline laparotomy closure with a BIOabsorbable mesh)~     is a multicenter randomized controlled trial in which adult patients undergoing elective or~     urgent open abdominal operations through a midline laparotomy incision are assigned to one of~     two groups based on the laparotomy closure procedure: an intervention group in which a~     continuous polydioxanone (PDS) suture is reinforced with a commercially available GORE®~     BIO-A® Tissue Reinforcement prosthesis (W. L. Gore & Associates, Flagstaff, Arizona, USA), or~     a control group with continuous PDS suture only. Both groups are followed over 6 months.~      Outcomes: The primary outcome is the appearance of incisional hernias assessed by physical~     examination at clinical visits and radiologically (CT scan) performed at the end of~     follow-up. Secondary outcomes are the rate of complications, mainly infection, hematoma,~     burst abdomen, pain, and reoperation. The PREBIOUS trial has the potential to demonstrate~     that suture plus prosthetic mesh insertion for routine midline laparotomy closure is~     effective in preventing incisional hernias after open abdominal surgery, to avoid the effects~     on those affected, such as poor cosmesis, social embarrassment, or impaired quality of life,~     and to save costs potentially associated with incisional hernia surgical repair.~   "
103812|NCT02208544|"~     The purpose of this study is to determine whether the use of molecular imaging using~     FDG-PET/CT could prevent unnecessary diagnostic thyroid surgery in case of indeterminate~     cytology during fine-needle aspiration biopsy.~   "
103813|NCT02208531|"~     We hypothesize that it is feasible to integrate a program of Nutritional Care and Pychosocial~     Stimulation into the Community Clinics in Bangladesh and thereby improve malnourished~     children's growth and development after a year of intervention.~   "
103824|NCT02208388|"~     The purpose of this study is to evaluate safety and effectiveness of CTP(computed tomography~     perfusion) guided revascularization vs FFR(Fractional flow reserve) guided revascularization~   "
103825|NCT02208375|"~     The goal of this clinical research study is to learn about and compare the highest tolerable~     doses and combinations of the drugs Lynparza™ (olaparib), AZD2014, and AZD5363 that can be~     given to patients with recurrent endometrial, triple negative breast, ovarian, primary~     peritoneal, or fallopian tube cancer. The safety of these drugs and drug combinations will~     also be studied.~   "
118795|NCT02012608|"~     This study is a single-centered, double-blind, two-arm randomized study to determine if oral~     glutamine will reduce radiation toxicity for the subjects undergoing Breast Conserving~     Therapy.~   "
103814|NCT02208518|"~     Endoscopic ultrasonography is considered the most accurate methods for the diagnosis and~     staging of chronic inflammatory and neoplastic pancreatic diseases. Differential diagnosis of~     solid pancreatic masses, however, remains a challenge and endoscopic ultrasound-guided fine~     needle aspiration is necessary. Recently, Endoscopic ultrasound elastography has been~     introduced as an alternative method to evaluate tissue stiffness of solid pancreatic masses,~     being an index of tissue elasticity, which may be related to histopathology features (hard~     tissue = blue = neoplastic and soft tissue = red-yellow-green = non-neoplastic). However,~     recently publications show different results using elastography. Moreover, a lack of data in~     Endoscopic ultrasound-elastography exist regarding the compression rate of the probe and the~     diameter of the region of interest under analysis in previously studies that by physics could~     affect the tissue elasticity.~      Based on the hypothesis that elastography could be affected by compression rate of the probe~     and the diameter of the region of interest analyzed the present study aimed to evaluate the~     quantitative (strain ratio) and qualitative endoscopic ultrasound-elastography results~     determined by the compression rate of the probe (measured by the curve of compression in the~     second generation of elastography) and the diameter of the region of interest in normal~     pancreatic tissue.~   "
103815|NCT02208505|"~     After thyroid surgery, the incidence and severity of coughing is important because it may~     cause serious complications, such as bleeding in the surgical field, laryngospasm, and~     cardiovascular disturbance. Several studies have shown that the single-dose of~     dexmedetomidine is effective for reducing cough and agitation during emergence from general~     anesthesia.~      To test the hypothesis that single-dose of dexmedetomidine combined with a low-dose~     remifentanil infusion during emergence from general anaesthesia could reduce coughing as good~     as high-dose remifentanil infusion, we will evaluate the efficacy on cough suppression and~     reduction of side effect of remifentanil using non-inferiority trial.~   "
103816|NCT02208492|"~     Unlike the first generation antiepileptic medications, newer drugs for epilepsy such as~     levetiracetam are reported to have less adverse effect in children but not many studies have~     systematically reviewed the subject. This study aims to prospectively evaluate the effect of~     levetiracetam on neurocognition, behavioral issues and quality of life, as well as its~     seizure control efficacy and other adverse events in pediatric epilepsy patients, in~     comparison to carbamazepine, one of the classic antiepileptic medication, widely prescribed~     for both partial and generalized seizures, despite its well known side effects.~      This multicenter, open-label, parallel-group trial is expected to enroll 130 patients from~     age 4 to 16 woh will be randomized into two groups, which will be prescribed with~     levetiracetam or carbamazepine. Series of neuropsychological assessment and behavioral and~     life evaluations of the patients will be performed at baseline period and after the 52 weeks~     of study period.~   "
103817|NCT02208479|"~     Diaphragm dysfunction is common after cardiac surgery and may delay weaning from mechanical~     ventilation and cause respiratory distress.~      The investigators' main objective is to determine the incidence of diaphragm dysfunction (~     using the non-invasive ultrasonic method by calculating the inspiratory diaphragmatic~     thickening fraction) in a selected population of cardiac surgery patients during weaning from~     mechanical ventilation.~      The second endpoints are to determine the associated risk factors to post-operative diaphragm~     weakness and the consequence on the patient outcome.~   "
103818|NCT02208466|"~     In this study investigator's aim to assess the effect of a type of non-invasive brain~     stimulation technique called repetitive transcranial magnetic stimulation (rTMS) in~     conjunction with fluoxetine on motor recovery after stroke.~   "
103819|NCT02208453|"~     The study objective is to assess the feasibility, efficacy and safety of the InSpace™ Device~     implantation in a surgical procedure under local anesthesia using arthroscopic and/or~     fluoroscopic visualization of the affected shoulder.~   "
103820|NCT02208440|"~     This is a post-marketing study to further assess the safety and effectiveness of the InSpace™~     device implantation in comparison to surgical repair of full thickness Massive Rotator Cuff~     Tear .~      The effectiveness will be assessed by comparing the scores of the ASES, Constant and Quick~     DASH outcome questionnaires with respect to pain reduction, improvement of activity of daily~     living (ADL) and improvement of range of motion (ROM).~   "
103821|NCT02208427|"~     Background:~      Tuberculosis (TB) remains the most important infectious disease in the world. Keys to~     successful control of TB is rapid diagnosis, prompt treatment, as well as effective~     preventive therapy for contacts with latent TB infection (LTBI). Current methods for the~     diagnosis of LTBI are tuberculin skin test (TST) and interferon-gamma release assay (IGRA).~     For preventive therapy, the recommended regimens include daily isoniazid for 9 months and~     daily rifampicin for 4 months. By incorporating long-acting rifapentine, a new regimen~     combining weekly rifapentine and high-dose isoniazid for a total of 12 doses has been proven~     of equal potency and toxicity. However, the treatment completion rate is much higher in~     weekly treatment for 3 months than daily treatment for 9 months. It is reasonable that using~     rifapentine-based preventive therapy can markedly increase the completion rate. However,~     study is lacking, especially in Asia, the high endemic area of TB.~      With the effort of all health care workers and public health personnel, the incidence of TB~     in Taiwan has gradually declined in recent 10 years. In order to maintain the trend of~     decreasing in incidence, preventive therapy for LTBI become more and more important. However,~     which is the best preventive regimen for LTBI is still unknown. Therefore, we conduct the~     prospective randomized multicenter studies to compare the treatment completion rate of two~     regimens in Taiwan. The first regimen is daily isoniazid for 9 months. The second is weekly~     rifapentine plus high-dose isoniazid for 3 months.~   "
103822|NCT02208414|"~     Purpose of this study is to determine whether NAET procedures are effective in the treatment~     of crab or shrimp allergy.~      Hypothesis: experimental group will show a significant improvement over the control group in~     allergic symptom, serum crab- or shrimp-specific IgE and skin test for crab or shrimp~     extract.~   "
103861|NCT02207907|"~     The primary objectives of this study will be to compare the Gingival Bleeding and Gingival~     Inflammation following twice daily use of a sodium bicarbonate experimental dentifrice~     compared to a 0% sodium bicarbonate toothpaste after 24 weeks of use. The study will be~     conducted at Silverstone Research Group. Participants will be recruited from their database~     and by use of an external recruitment agency.~   "
103828|NCT02208336|"~     This research trial studies electronic medical record review in monitoring the effects of~     adherence on myelosuppression and morbidity in patients with newly diagnosed brain tumors~     receiving temozolomide and radiation therapy. Myelosuppression is a condition in which bone~     marrow activity is decreased, resulting in fewer red blood cells, white blood cells, and~     platelets and is a side effect of some cancer treatments. Morbidity is a term that refers to~     having a symptom of disease or medical problems caused by a treatment. Monitoring patients'~     electronic medical records to compare side effects, such as myelosuppression and morbidity,~     with treatment adherence may be a way to enhance patient care by organizing data for medical~     staff.~   "
103829|NCT02208323|"~     This study proposes that modifying the current form of bCPAP by adjusting the nasal prongs to~     fit older children, will create a safe form of respiratory support that may help to decrease~     respiratory distress and thus mortality from pneumonia.~   "
103830|NCT02208310|"~     Crohn's disease is more common in areas of the world with less sunlight exposure. Sunlight is~     a major source of vitamin D. There is some research to suggest that patient's with higher~     vitamin D levels are less likely to undergo surgeries and have better control of their~     disease. We intend to study the effects of high dose vitamin D supplementation in patients~     with vitamin D deficiency and Crohn's disease. We hypothesize that patients given high doses~     will have less hospitalizations, surgeries, steroid use.~   "
103831|NCT02208297|"~     The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate~     (LE) ophthalmic gel, 0.38% (BID)~   "
103832|NCT02208284|"~     PF-06427878 is a new compound proposed for the treatment of hyperlipidemia. The primary~     purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single~     oral doses of PF-06427878 in healthy adult subjects.~   "
103833|NCT02208271|"~     The purpose of the study is to develop a biomarker assay to be used as a diagnostic tool for~     adverse local tissue reaction, or tissue necrosis, in a metal on metal total hip replacement.~      A convenience sample of a total of 100 hip patients will be enrolled: 50 metal-on-metal~     revision hips, 25 metal-on-poly revision hips, and 25 pre-operative total hips (no implant,~     control group) will be enrolled. Preoperative blood serum samples and intraoperative synovial~     fluid will be obtained from all hips and used for biomarker testing. Additionally,~     intraoperative assessment of tissue necrosis will be assessed.~   "
103834|NCT02208258|"~     The purpose of this study is to evaluate the safety, efficacy, and functionality of the~     Consure 120 Stool Management System in hospitalized bedridden patients suffering from fecal~     incontinence.~   "
103835|NCT02208245|"~     The brachial plexus block is an anesthetic technique often used for surgical procedures of~     the upper limb. To get the brachial plexus block, several routes can be used, including the~     axillary and infraclavicular approach.~      Few studies have compared these techniques, considering the time to perform the block, the~     onset time and success rate, with conflicting results. Furthermore, there is little~     information in the literature comparing the length of postoperative analgesia provided by~     these techniques.~      Therefore, the investigators designed this study in order to elucidate the differences~     between these two techniques to assist the anesthesiologist to choose the best of them in~     clinical practice.~   "
103836|NCT02208232|"~     The purpose of this study is to assess the axial IOL rotation after surgery with an MC 6125~     AS IOL.~      At the end of surgery the orientation of the IOL is documented with a short video clip via~     the operating microscope unit. Follow-up examinations are performed 1 hour, 1 week and 6~     months after surgery. Rotational stability of the IOL is assessed using retroillumination~     images with a method to avoid bias from cyclorotation or head tilt.~   "
103837|NCT02208219|"~     Motor deficits are common after stroke, being one of the major causes of disability in this~     population. Because of the impact that motor impairments have in the life of patients and the~     associated financial costs, it is a health care priority to develop effective and efficient~     treatments to restore motor deficits. Music-supported therapy (MST) has been recently~     developed to enhance the use of the affected extremity after stroke.~      In the present project, a new multidisciplinary approach (neurology, neuropsychology, music~     and cognitive neurosciences) will be undertaken in order to investigate the effectiveness of~     MST as a neurorehabilitation technique to restore the motor function in stroke patients. In~     addition, the complex pattern of reorganization of the sensorimotor system will be studied in~     order to provide information about the physiological mechanisms underlying the~     neurorehabilitation process.~      A randomized controlled trial is proposed to compare for first time the effectiveness of MST~     (at the hospital and at home) compared to conventional treatment in subacute stroke patients~     suffering from motor deficits. Our hypothesis is that patients will experience a large~     improvement in the functional use of the affected arm due to the implementation of the MST~     program when compared to conventional treatment. We also expect to observe improvements in~     cognitive functions, mood and quality of life. Besides, we hypothesize that these~     amelioration in motor and cognitive domains will be accompanied by neuroplastic changes in~     the sensorimotor cortex and corticospinal tract.~   "
103838|NCT02208206|"~     The purpose of this study is to analyze associations between symptoms and specific markers in~     the blood in patients suffering from neuropathic pain linked to diseases of different origin.~     Such markers could be utilized in the future for precise diagnosis of neuropathic pain and~     might lead to targeted pain treatment.~   "
103857|NCT02207959|"~     The overall objective of this pilot study is to determine whether multispectral imaging~     increases the diagnostic accuracy of the current standard of high-definition white-light~     endoscopy for the detection of gastric neoplasia (high grade dysplasia or cancer). As part of~     an NCI-funded RO1, the investigators goal is to develop a multispectral endoscopic platform~     that can be used to survey a large surface area and, potentially, serve as a red flag for~     microendoscopic imaging of small areas. In prior ex vivo evaluations of surgical and~     endoscopic specimens, the investigators have identified the optical settings and illumination~     wavelengths that are complementary to white-light imaging and enhance superficial mucosal and~     vascular changes associated with neoplasia. Based on this initial testing, vital-dye enhanced~     fluorescence imaging (VFI) and imaging with High Resolution Microendoscope (HRME) have been~     identified as modalities that may be complementary to white-light imaging. The goal of this~     pilot study is to preliminarily determine the accuracy of these modalities during the~     endoscopic surveillance and detection of gastric neoplasia.~   "
103839|NCT02208193|"~     Gardens and art represent public spaces and support venues of interactions and emotions,~     seeking not only a variety of conversational themes but also various cognitive skills such as~     mnemonic skills. The cognitive and psycho-behavioral effects of art and the garden, jointly~     associated and made available to patients suffering from Alzheimer's disease, need to be~     evaluated.~      MAIN OBJECTIVE Delineate the psychological scaffolding virtues of art and garden on cognitive~     and emotional processes by means of interview analyses in Alzheimer patients and control~     subjects based on the  art, memory and life  garden.~      SECONDARY OBJECTIVES Adapt eco-psychosocial approaches of care management to Alzheimer~     patients:~        -  create assessment methods of:~        -  the therapeutic efficacy of the design of the  art, memory and life  garden,~        -  the perception of an artistic dimension in the living environment of those with~          Alzheimer's disease,~        -  establish:~        -  workshop applications using art and the garden for therapeutic purposes,~        -  general recommendations for the layout of the garden. PRIMARY ENDPOINT Quantitative data~          of discursive productions stemming from Interlocutory Logic (Trognon and Batt, 2007,~          2010, 2011) for the analysis of interactive behaviors and the assessment of parameters~          including esthetic appraisals, well-being, mnemonic and emotional processes (frequency~          and nature of these processes) as well as spatio-temporal orientation.~      SECONDARY ENDPOINTS~        -  Scores obtained in standard neuropsychological tests, in particular to assess~          spatio-temporal orientation (Folstein MMSE),~        -  Scores obtained with the  MemoArtZ  tool (MAZ) to evaluate the memorization of~          artistic elements of the garden,~        -  Scores from the  General Esthetic Preference  (GEP) tool to evaluate the consistency~          of general esthetic appreciations,~        -  Score obtained with the specific mood assessment scale (CSDD) for subjects in group A,~        -  Score obtained with the specific assessment of emotional events scale (AES) for all~          subjects.~      RESEARCH METHODOLOGY~      Open, monocentric, controlled (group of healthy control subjects) study.~      Population: 2 groups:~      Group A Alzheimer group: patients with mild to severe stages of Alzheimer's disease:~     subgroup A1 Alzheimer group hospitalized at the Paul Spillmann Centre (Centre Paul~     Spillmann, CPS) (CHU de Nancy, France); subgroup A2 Alzheimer group monitored at the~     Resource and Research Memory Centre (Centre Mémoire de Ressources et de Recherche, CMRR)~     (CHU de Nancy, France) Group B healthy control group: healthy volunteers~      Therapeutic fallouts of this study will benefit Alzheimer patients in terms of better care~     management, notably: i) by determining the design, conception and layout of the gardens~     destined to these patients, ii) by developing the introduction of an artistic dimension to~     the design of such healing gardens and in their living environment, iii) by establishing~     workshop application perspectives using the contemplation of works of art and the garden for~     therapeutic purposes.~   "
103840|NCT02208180|"~     The investigators are conducting a two group intervention to study to the effect of~     individualized heart disease genomic risk results on motivation towards diet and physical~     activity behaviors to reduce heart disease risk. The intervention includes provided~     participants with genomic and lifestyle risk estimates. Investigators will follow~     participants for 3 months to determine if motivation towards and engagement in diet and~     physical activity behaviors change.~   "
103841|NCT02208167|"~     This is a phase 1, single-site study is to evaluate the safety and immunologic and virologic~     efficacy of ex vivo expanded HIV-1 multi-antigen specific T-cell (HXTC) therapy in~     HIV-infected individuals with viral suppression on antiretroviral therapy (ART).~   "
103842|NCT02208154|"~     Previous research has shown that applying certain treatments can reduce both the number of~     infections and the presence of resistant bacteria in the intensive care (ICU) and its~     patients. These treatments have been used as standard care throughout the world for many~     years, but they have not been compared to each other yet. The investigators aim to evaluate~     the effect of 3 different treatments on the occurrence of resistant bacteria and bacterial~     infections in the ICU and to establish which treatment is the best.~      All adult patients undergoing mechanical ventilation are eligible for this study and will~     receive treatment according to the study scheme. Twice weekly, sputum and rectal samples will~     be obtained to measure the effects.~      All ICU-patients will receive standard treatment, consisting of daily body washing with an~     antiseptic (chlorhexidine 2%), oral care and a hand-hygiene program for health care workers~     as endorsed by the WHO. According to 4 different study periods, each participant will receive~     one of the following extra treatments depending on his or her admission date:~        -  Standard treatment only (this is the control group)~        -  Chlorhexidine 1% oral gel, this is an antiseptic.~        -  Antibiotic mouth paste containing 3 different antibiotics (selective oropharyngeal~          decontamination, SOD).~        -  Antibiotic mouth paste and suspension for the stomach and intestines containing 3~          different antibiotics (selective digestive decontamination, SDD).~      All treatments will be given 4 times daily with the purpose of killing harmful bacteria in~     the mouth (CHX, SOD,SDD) and digestive tract (SDD).~      During the study the investigators will examine the effect of these treatments on:~        -  the occurrence of blood stream infections with certain bacteria~        -  cross-transmission of certain bacteria between patients~        -  presence of these bacteria in the respiratory tract of the patients~        -  patient survival~      Benefits: Previous research has shown that these interventions can reduce infections in~     intensive care patients.~      Risks: The interventions performed (both cultures and treatment) are considered safe and are~     already given as standard care in many ICUs throughout the world. There is a slight risk that~     bacteria become resistant to antibiotics: this will be monitored closely during the trial.~   "
103843|NCT02208141|"~     In this study the investigators hypothesize that pathological alterations in adipose tissue~     biology already occur during the development and progression of obesity in children and~     adolescents. The investigators aim to identify and characterize mechanisms and molecular~     targets that affect the development of adipose tissue and ensuing obesity in childhood and~     adolescence.~   "
103844|NCT02208128|"~     Aim of the scientific analysis is to find biological factors (biomarkers) allowing a~     prediction of disease progression and a better choice of therapy. After diagnosis the kidney~     and the tumor will be removed by standard surgery followed by drug therapy. Within surgery~     remaining tumor tissue will be used for the scientific analysis. In case of disease~     progression during the drug treatment the drug therapy will be changed. Before therapy change~     a small tissue sample will be collected for molecular diagnostics. This will be done by~     puncture through the skin under local anesthesia. Blood samples taken before surgery and at~     the time of first and second disease progression will also be used for molecular-biological~     analysis. As there is no clear recommendation for drug therapy after disease progression this~     study should serve to determine an individual therapy on the basis of the molecular profile~     and the molecular changes. As the tumor disease changes and developes resistance to drugs,~     analysis at the time of disease progression shall identify biological factors which will~     predict a likelihood response to a specific drugs.~      This shall allow to give the patient an individual therapy.~   "
103845|NCT02208115|"~     The investigators hypothesise that manipulating the glycaemic index of the meal after~     exercise will influence the acute appetite responses of Type 1 diabetes individuals~   "
103846|NCT02208102|"~     The purpose of this study is to assess if pre-ablation levels of inflammatory biomarkers~     serve as independent predictors of procedure outcome To evaluate the inflammatory activation~     following catheter ablation by measuring serum-biomarker levels 24-hours after the procedure~     and examine the predictive role in procedure success To study the association of certain~     biomarkers with specific types of AF (paroxysmal or persistent or long standing persistent)~   "
103858|NCT02207946|"~     The objective of this study is to assess the efficacy and safety of a single,~     kinematic-analysis-based intramuscular injection of NT 201, compared with placebo, in~     moderate to marked essential tremor of the upper limb.~   "
103859|NCT02207933|"~     To investigate the effect of anteroposterior weight shifting training with visual biofeedback~     on step length asymmetry. Reduced speed and asymmetry of stepping is a specific~     characteristic of hemiplegic gait. Asymmetry of stepping is characterized by shorter step~     length of the unaffected limb compared to the affected limb. Causes of this phenomenon are~     difficulty in weight bearing at the affected limb, weak propulsive force of the affected~     limb, and decreased strength of hip extensors. To correct these factors. we have developed an~     anteroposterior weight shifting training system with visual feedback and studied its effects.~   "
103847|NCT02208089|"~     Young patients with keratoconus face two problems: disease progression and corneal shape~     irregularity leading to poor vision even in spectacles.~      Corneal collagen cross-linking (CXL) is a new treatment designed to halt disease progression~     in keratoconus. The aim is to stiffen the cornea thereby preventing further shape~     deterioration.~      Topography or wavefront guided transepithelial photorefractive keratectomy (transPRK) uses~     the excimer laser (the laser used to correct sight in 'laser eye surgery') to reduce corneal~     shape irregularity in early stage keratoconus, reducing dependence on contact lenses.~      In transPRK, the corneal skin layer is removed in a well controlled, no touch procedure,~     preparing the cornea for CXL. Performing both treatments simultaneously (combining both~     procedures in one operation) may offer several advantages over performing CXL first then~     waiting for corneal shape to stabilise before performing transPRK. In particular, visual~     rehabilitation may be faster. This study aims to evaluate visual recovery after simultaneous~     CXL and transPRK in progressive early stage keratoconus. Visual recovery in these patients~     will be compared with results for a similar group of patients with early stage keratoconus~     who have already been treated with CXL alone.~   "
103848|NCT02208076|"~     This is a Columbian, Multicentre, Observational Study to evaluate Adherence and Long Term~     Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth~     hormone treatment and to assess the level of adherence of subject receiving SAIZEN® via~     easypod™.~   "
103849|NCT02208063|"~     This is a multicenter, randomized, open-label, noninferiority trial of telavancin versus~     standard IV therapy control (e.g., vancomycin, daptomycin, anti-staphylococcal penicillin~     (PCN), or cefazolin) in the treatment of subjects with complicated Staphylococcus aureus (S.~     aureus) bacteremia and SA right-sided infective endocarditis (RIE).~   "
103850|NCT02208050|"~     The purpose of this study is to examine the effect of treatment with fampridine in patients~     with secondary progressive MS (SPMS) or primary progressive MS (PPMS) with upper limb~     dysfunction (as defined by a 9-HPT time of between 15-90 seconds) and Kurtzke EDSS scores in~     the range 4.0-7.0 on upper limb function assessed by the nine-hole peg test (9-HPT) and the~     Jebson Taylor Hand Function Test (JTT).~      Fampridine has been shown to be effective in improving motor function, specifically walking~     ability in prior studies in this patient population and is currently licensed for this use in~     Europe and the United States. Upper limb dysfunction is common in SPMS and PPMS and often~     underestimated. Fampridine effects action potential conduction in demyelinated nerve fibres~     and we would hypothesise that the improvement previously reported in walking ability would be~     similar to that on upper limb dysfunction. Our study aims to address this question using both~     independent and patient reported outcomes in the context of a randomised placebo controlled~     crossover trial.~   "
103851|NCT02208037|"~     Acute Graft-versus-Host-Disease (GVHD) is an important cause of morbidity and mortality after~     allogeneic hematopoietic stem cell transplantation (HSCT). This study aims to determine if~     any of three new GVHD prophylaxis approaches improves the rate of GVHD and relapse free~     survival at one year after transplant compared to the current standard prophylaxis regimen.~   "
103852|NCT02208024|"~     The purpose of this study is to test the safety of focused radiation (Stereotactic Body~     Radiation Therapy, SBRT) on patients with pancreatic cancer that will be removed surgically.~   "
103853|NCT02208011|"~     Specific objectives include analysis of performance of ROM Plus® in diagnosing ROM, as~     compared to Amnisure® and the conventional clinical assessment confirmed by a thorough chart~     review after delivery.~      Inclusion Criteria:~        -  English speaking~        -  pregnant woman >15 weeks gestation undergoing an exam for ruptured membranes~      Exclusion Criteria:~        -  Known placental previa~        -  Active vaginal bleeding~   "
103854|NCT02207998|"~     Osteoarthritis (OA) is a chronic arthropathy characterised by disruption and possible loss of~     joint cartilage along with other joint changes. OA symptoms include progressively developing~     joint pain provoked or elicited by activity, joint stiffness that lasts for less than 30~     minutes on waking and after activity, and occasional joint swelling. It is a common specific~     mechanical cause of chronic low back pain. Conventional treatment for OA includes~     physiotherapy treatment and drugs such as paracetamol, non-steroidal anti-Inflammatory drugs~     (NSAIDs), intra-articular injection of corticosteroids and surgery, however these may have~     possible side effects. Arnica montana, Bryonia alba, Rhus toxicodendron, Causticum, Kalmia~     latifolia and Calcarea fluoride are homoeopathic remedies indicated and used in the treatment~     of OA, however, there is no evidence of studies conducted on a complex made up of these~     remedies.~      The aim of the study is to investigate the efficacy of the homoeopathic complex (Arnica~     montana 6CH, Bryonia alba 6CH, Causticum 6CH, Kalmia latifolia 6CH, Rhus toxicodendron 6CH~     and Calcarea fluoride 6CH) and physiotherapy in the treatment of chronic low back pain due to~     osteoarthritis, using the Oswestry Low Back Pain Disability Questionnaire, range of motion~     (ROM) measurement using the attraction tape and the visual analogue pain scale (VAS) .~   "
103855|NCT02207985|"~     Aim:~      To study the antitumour effect of reduced intensity conditioning (RIC) with allogeneic stem~     cell transplantation (HSCT) in patients with pancreatic adenocarcinoma after radical~     resection of the tumour and adjuvant treatment with standard chemotherapy.~      Importance:~      If investigators can accomplish an anti-tumour effect using RIC with HSCT as adjuvant~     treatment in patients with pancreatic adenocarcinoma, it might increase the survival or even~     cure patients in this group with very poor prognosis.~      Primary scientific question:~      Can investigators demonstrate an anti-tumour effect against pancreatic adenocarcinoma using~     adjuvant treatment with HSCT?~      Can investigators demonstrate an anti-tumour effect against pancreatic adenocarcinoma using~     adjuvant treatment with HSCT?~   "
103856|NCT02207972|"~     The investigators believe that ultrasound guided CSE technique will accurately place the~     epidural needle in the midline position compared to epidural needle placement via palpation~     of anatomical landmarks. This will result in positive CSF in the spinal needle, correct~     placement of the catheter, and adequate symmetrical labor analgesia/anesthesia.~   "
103860|NCT02207920|"~     This study will evaluate the safety, tolerability, and immune response to different~     combinations of two experimental HIV vaccines—the DNA-HIV-PT123 vaccine and the AIDSVAX® B/E~     vaccine—in healthy adults who are not infected with HIV.~   "
103892|NCT02207504|"~     This research study is comparing the combination of drugs Crizotinib and Enzalutamide as a~     possible treatment for metastatic castration-resistant prostate cancer (mCRPC).~   "
103862|NCT02207894|"~     This research program is initiated to evaluate and document data on the success of ITI in 300~     haemophilia A patients with newly developed or already existing FVIII-inhibitors (also~     patients who might potentially have failed in earlier ITIs), which will be treated with ITI -~     preferably high-dose based on individualized product selection, in order to improve~     management of this potentially devastating complication of haemophilia treatment.~      In order to investigate the role of in vitro tests on individual ITI success rate in patients~     undergoing ITI, the inhibitor plasma samples can be assayed against different FVIII~     concentrates using the following in vitro tests: Batch selection, Thrombin generation assay~     (TGA), Thrombin Generation Test (TGT) to monitor FVIII efficacy, Epitope mapping,IgG~     Subclasses specific for FVIII, Immunogenotyping.~   "
103863|NCT02207881|"~     Recurrent herpes labialis are usually a minor malady of limited duration, although they are~     often painful and are uniformly discomforting for patients. Oral antivirals represent an~     advance in the treatment of recurrent herpes labialis, but the clinical implications are~     modest. Randomized, controlled clinical trials have shown that oral antivirals decrease the~     duration of lesion episodes and pain by approximately one day. In recurrent HSV infections~     including herpes labialis, many instances of viral re-activation occur without symptoms, and~     can only be identified by detection of virus on the lips of infected individuals. In these~     cases, the virus is cleared from the local site without the development of a classical~     ulcerative herpes lesion. In the other cases, the triggered specific immune response rapidly~     stops viral replication in the skin and also causes the development of the herpes lesion~     prodrome and a considerable part of the symptoms associated with a classical ulcerative~     herpes lesion. One could therefore predict that treatment with an antiviral drug alone would~     help the immune system in shortening the virus replication, but may not substantially reduce~     the disfiguring symptoms caused by the immune reaction. In dermatology, the principle of~     using an anti-inflammatory drug improve clinical outcomes by reducing inflammation-related~     symptoms associated with the infection has been well established. We have found that a~     topical formulation of VDO is useful for alleviating pain and inflammation associated with~     infection caused by herpes virus.~   "
103864|NCT02207868|"~     The aim of the study is to document the left and right ventricular function in patients with~     sclerodermia associated pulmonal arterial hypertension via 3D echocardiography. The results~     of this study should help to generate hypothesis for further future studies.~      The primary hypothesis is that the increased use of modern image guided methods could provide~     essential aspects for the follow up.~   "
103865|NCT02207855|"~     This a study to retrospectively review our experience with the use of chloroprocaine for~     postoperative epidural infusions in neonates and infants. Pain scores and the need for~     intravenous analgesic agents will be recorded from the records to demonstrate the efficacy of~     the technique.~   "
103866|NCT02207842|"~     One of the most common side effects of a surgical procedure is infection. In order to lower~     the number of infections that occur after surgery, it is important for physicians to know how~     medications used during surgery affect the way the body fights infection. Often, when~     anesthesiologists are helping people go to sleep before surgery they give people medications~     known as volatile anesthetics. Volatile anesthetics are medications that can change from a~     liquid or solid to a gas very easily. Some studies suggest that these types of medications~     may change the way white blood cells work in the body. Changing the way white blood cells~     work could possibly increase the person's risk of infection after their surgery or weaken~     their body's ability to fight infections. The goal of this research study is to learn about~     how volatile anesthesia medications change the way white blood cells work in people having~     anesthesia for cardiac procedures. To do this, investigators will examine the function of~     while blood cells in the laboratory based setting.~   "
103867|NCT02207829|"~     This is a multicentre, randomized, blinded, double dummy, parallel group study to evaluate~     the efficacy and safety of UMEC inhalation powder[ (62.5 microgram (mcg) once daily (QD)]~     when administered via a novel Dry Powder Inhaler compared with tiotropium (18 mcg QD)~     administered via a HANDIHALER® inhaler over a treatment period of 12 weeks (24 weeks in~     Germany) in subjects with chronic obstructive pulmonary disease (COPD). At the end of the~     run-in period, subjects who meet the randomization criteria will be randomized to receive~     UMEC 62.5 mcg administered via novel dry powder inhaler(nDPI) + Placebo administered via~     HANDIHALER inhaler OR Tiotropium 18 mcg administered via HANDIHALER inhaler + Placebo~     administered via nDPI in a 1:1 ratio. There will be up to 8 clinic visits conducted on an~     outpatient basis at Pre-Screening (Visit 0), Screening (Visit 1), a 7 to 14 day run-in~     period, randomization at Day 1 (Visit 2), and after randomization at Day 2 (Visit 3), Day 28~     (Visit 4), Day 56 (Visit 5), Day 84 (Visit 6) and Day 85 (Visit 7). For subjects enrolled in~     Germany, there will be an additional 3 visits at Day 112 (Visit 8), Day 140 (Visit 9) and Day~     168 (Visit 10). The total duration of subject participation in the study will be~     approximately 15 weeks (27 weeks in Germany). The primary endpoint of the study is clinic~     visit trough forced expiratory volume in one second (FEV1) on treatment Day 85. All subjects~     will have spirometry performed at clinic Visits 1 though 7. Trough spirometry will be~     obtained 23 and 24 hours after the previous day's dose of blinded study medication at Visits~     3 to 7.~      HANDIHALER is a registered trademark of Boehringer Ingelheim Pharma GmbH & Co. KG.~   "
103868|NCT02207816|"~     The purpose of this study is to conduct long-term surveillance for efficacy, safety and~     immunogenicity of the GSK Biologicals RTS,S/AS01E candidate Plasmodium falciparum malaria~     vaccine in infants and children in Africa following a primary vaccination series~     (NCT00866619). No new subjects will be enrolled in this extension study.~   "
103869|NCT02207803|"~     Traumatic brain injury (TBI) patients in Latin America experience high levels of disability~     and extremely poor functional outcomes, and their informal caregivers play a key role in~     their rehabilitation and care. To improve TBI rehabilitation through stronger informal~     caregiving, the proposed study will develop and evaluate an evidence--based and culturally~     sensitive Transition Assistance Program for informal caregivers of patients with TBI in Latin~     America during the patient's transition from hospital to home. This study will generate~     findings that can provide empirically supported guidance to clinicians regarding the~     provision of culturally tailored rehabilitation services for TBI caregivers in Latin America~     and in the U.S.~   "
103893|NCT02207491|"~     To evaluate the ocular hypotensive efficacy and ocular and systemic safety of AR-13324~     Ophthalmic Solution, 0.02% compared to the active comparator Timolol maleate Ophthalmic~     Solution, 0.5%~   "
103870|NCT02207790|"~     This study is primarily designed to bridge the pharmacokinetics (PK) and safety data for~     E2609 between Japanese subjects and non-Japanese (ie, white) subjects. To bridge these PK~     characteristics, the proposed study includes a cohort of white subjects treated for~     comparison with the cohort of Japanese subjects treated at the same dose. This comparison~     serves as a key PK bridge in assessing ethnic factors that may contribute to differences in~     plasma concentrations. Pharmacokinetic assessments in the proposed study will include~     confirmation of dose proportionality in Japanese subjects. This study will also evaluate~     safety and tolerability in Japanese subjects.~   "
103871|NCT02207777|"~     For this purpose, we will compare the effects of 16-18% weight loss induced by Roux-en Y~     Gastric bypass (RYGB) surgery or sleeve gastrectomy (SG) surgery with the same weight loss~     induced by a low-calorie diet (LCD) on liver and skeletal muscle insulin sensitivity,~     beta-cell function, and 24-hour metabolic homeostasis in obese subjects with T2D.~   "
103872|NCT02207764|"~     This research is being done to test whether a complementary intervention, Reiki therapy, can~     provide added benefits to the standard patient care. Reiki is method for stress reduction~     that uses hand positions over and/or on the body to help people relax.~      We are studying the effect of a 15-minute Reiki application compared to an intervention of~     nursing presence without Reiki. We hope to find if Reiki can assist in relieving stress, and~     improving patient outcomes. In the future we would like to offer complementary interventions~     as an adjunct to our standard care for patients.~   "
103873|NCT02207751|"~     The objective is to understand the best way to place Peritoneal Dialysis (PD) catheters, and~     the best way to collect data regarding their function in England, Wales and Northern Ireland.~      Phase 1: We will carry out a detailed examination of existing returned pilot data with~     emphasis on data fields with poor data completeness and perform root cause analysis, and~     assess deficiencies in data field definition to identify improvements to be implemented. We~     will construct and disseminate electronic survey material to all study centres with targeted~     visits by the Principle Investigator undertaken. These visits will facilitate insight into~     local organization of data collection including interaction with designated individuals~     responsible for data returns. PD training days will be organized with emphasis on clinical~     practice feedback utilizing data acquired in the initial phases. Hospital Episode Statistics~     will be linked to existing acquired PD patient information to ensure the accuracy of~     collected data. An online data acquisition system will be developed to allow direct data~     entry from centres.~      Phase 2: On-going and sustained data acquisition performed on a prospective basis.~      Phase 3: Primary data analysis including clinical practice variation in England, Wales and~     Northern Ireland to identify site specific PD catheter functionality variation. Additionally,~     patient and site specific characteristics that predict clinical outcomes in PD will be~     identified and characterised.~      Phase 4: Clinical guidelines will be developed.~   "
103874|NCT02207738|"~     Compare the efficacy and safety profile of microneedling radiofrequency and that of bipolar~     radiofrequency treatment for acne scar.~   "
103875|NCT02207725|"~     The purpose of this stuy is to evaluate the ability of Andexanet Alfa to reverse the~     anticoagulation effect of Apixaban.~   "
103876|NCT02207712|"~     In this study, the investigators aim to use light masks (Noctura 400) to test the hypothesis~     that preventing the dark adaptation and associated hypoxia of the rods in the eye could in~     turn prevent or halt the progression of centre-involving Diabetic Macular Oedema (DMO). DMO~     is a devastating disease that is the most common cause of registerable blindness in the~     working age-group in the United Kingdom (UK)~      This is a multi-centred randomised controlled trial involving 240 patients. Post~     randomization, participants in the intervention arm will wear the Noctura 400 Light Mask at~     night for 48 weeks in conjunction with their routine, prescribed treatment of intravitreal~     (eye) ranibizumab. Those in the standard arm will receive their routine, prescribed~     ranibizumab treatment only.~      The primary objective is to determine whether utilizing the Noctura 400 Light Mask at night~     reduces the number of intravitreal injections of ranibizumab required by patients undergoing~     such a course for the treatment of DMO.~   "
103877|NCT02207699|"~     The primary objective of this study is to determine the effects of benzonatate (200 mg and~     800 mg) on the QT interval following single dose oral administration at each time point~     post-dose.~   "
103878|NCT02207686|"~     The investigators aim to analyze tumors from vHL patients who have different courses of~     disease and different types of VHL gene alterations to characterize which types of genetic~     alterations the tumors contain and how these alterations affect the tumor cells' behavior on~     a molecular level. The investigators will then compare these observations to vHL disease~     outcome in patients and families.~      It is already known that most vHL tumors develop when both copies of the VHL gene in a cell~     are inactivated. The first copy is inactivated in all the person's cells from birth (first~     hit), leaving just one functional copy. A tumor can develop from cells where the second copy~     is also inactivated (second hit). So far, only the molecular consequences of the first hit~     have been investigated. It is our hypothesis that both the first and second hits in~     combination have consequences for tumor development and clinical outcome. The investigators~     will include tumors from patients with different disease courses and different types of~     first hits and analyse the tumors' DNA in order to find correlations between the first and~     second hits and patients' and families' medical histories. The investigators hereby hope to~     give new insights into how vHL tumors grow and which genetic factors influence tumor~     development. These results will contribute to the current knowledge of vHL and help us get~     one step closer to be able to predict an individual's tumor risks and need for surveillance.~   "
103894|NCT02207478|"~     The purpose of this study is to evaluate the efficacy and safety of electromagnetic~     navigation bronchoscopy with a Guide Sheath(ENB-GS) for the diagnosis of peripheral pulmonary~     lesions (PPLs) .~   "
103910|NCT02207257|"~     This study will evaluate the establishment of anticoagulation (re-anticoagulation) of~     subjects with edoxaban following reversal by PER977 and will identify a dose regimen of~     PER977 that reverses the effects of edoxaban for up to 21 hours.~   "
103911|NCT02207244|"~     The purpose of this study is to evaluate the efficacy, safety, and tolerability of guselkumab~     (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis~     (scaly skin rash).~   "
103912|NCT02207231|"~     The purpose of this study is to evaluate the efficacy, safety, and tolerability of guselkumab~     (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis.~   "
103879|NCT02207673|"~     Epilepsy occurs in 0.5-0.7% of the population, of which 25% are children. 30% Of patients~     with focal epilepsy do not respond well to medication and half of them are eligible for~     epilepsy surgery. In recent years, the importance of early epilepsy surgery has been~     stressed, as successful surgery may lead seizure and medication freedom and improved social~     and cognitive development, especially in children. The current success rate of epilepsy~     surgery is around 65%; During surgery intracranial electrocorticography (acute ECoG, aECoG)~     is recorded in some medical centers. The presence of epileptiform brian activity, spikes,~     identified by clinical neurophysiologists, is used to guide the neurosurgeon in the extent of~     the brain tissue that needs to be resected. Spikes are considered markers of the presence of~     epilepsy. High Frequency Oscillations (HFOs, >80-500Hz) in the ECoG have recently been~     identified as a new biomarker for epileptogenic tissue. Retrospective research shows that~     their local presence strongly relates to the seizure onset, and removal of tissue with HFOs~     could predict a better surgical outcome. The area showing HFOs usually overlaps with, but is~     smaller than the area with spikes, and HFOs do not tend to propagate to distant sites as~     spikes do. The identification of HFOs is more objective than of spikes and automatic~     detection software exists.~      A pilot study is performed to test the hypothesis : The intra-operative use of HFOs to~     delineate the epileptogenic cortex does not yield significantly worse outcome in seizure~     freedom than the current method based on spikes.~      Study design is a single blinded multi-center randomized controlled trial. In two Dutch~     centers, the VU medical center ( Amsterdam) and University Medical Center Utrecht.~      The study population (sample size 78) consists of patients of all ages with refractory~     epilepsy undergoing epilepsy surgery with aECoG to guide the extent of the resection.~      Eligible patients are randomised, after informed consent, into group 1 (HFOs) in whom a~     resection guided by HFOs in the aECoG (new), or into group 2 (spikes) in whom a resection is~     guided by epileptiform spikes in the aECoG (current standard). Ictiform spike patterns will~     always be resected.~      Main study endpoint is outcome after epilepsy surgery after 1 year of follow-up dichotomized~     in total seizure freedom (Engel Ia&b) vs. seizure recurrence (Engel Ic-IV).~   "
103880|NCT02207660|"~     Objectives: To evaluate the effectiveness and toxicity of the combination of infusional~     cisplatin and 24-hour infusion of high-dose fluorouracil plus leucovorin (P-HDFL) repeatedly~     every 21 days for the treatment of stage IVB, recurrent or metastatic carcinoma of cervix.~      Methods: The medical records of all patients with stage IVB, recurrent or metastatic cervical~     cancer who were treated with P-HDFL regimen between January 2005 and December 2009 at~     National Taiwan University Hospital were reviewed.~      Expected results: Investigators will identify the effectiveness and toxicity of the~     combination of infusional cisplatin and 24-hour infusion of high-dose fluorouracil plus~     leucovorin (P-HDFL) repeatedly every 21days for the treatment of stage IVB, recurrent or~     metastatic carcinoma of cervix.~   "
103881|NCT02207647|"~     Of all emergency room patients, persons presenting with encephalitis/meningitis syndrome of a~     potentially infectious nature are among those of greatest concern. Routine clinical and~     laboratory evaluation of such patients involves screening for known infectious disease~     agents, selection of which is nonstandardized. Progress in diagnostic technologies,~     especially molecular techniques based on genetic characteristics of potential pathogens, has~     greatly expanded the investigators capacity to evaluate specimens from patients for a much~     wider range of potential pathogens (bacterial, viral, fungal and parasitic agents). Use of~     Polymerase Chain Reaction (PCR) technology offers the possibility of identifying causative~     agents for the approximately 50% of all such presentations which go un-diagnosed. The~     investigators propose a study involving a collaboration between the EMERGEncy ID NET, a~     network of 10 geographically diverse university-affiliated urban emergency departments~     (coordinated by Olive View-UCLA Medical Center) and the Centers for Disease Control and~     Prevention (CDC), to use these new technologies to address this issue.~   "
103882|NCT02207634|"~     This study evaluated change over time in neurocognitive testing in patients receiving statin~     therapy in combination with evolocumab (AMG 145), compared with patients receiving statin~     therapy in combination with placebo.~   "
103883|NCT02207621|"~     Evaluation of the ocular hypotensive efficacy and safety of Netarsudil (AR-13324) Ophthalmic~     Solution compared to Timolol Maleate Ophthalmic Solution~   "
103884|NCT02207608|"~     The purpose of this study is to evaluate a possible role of intravesical Hyaluronic Acid in~     reducing local toxicity of Bacillus Calmette Guerin (BCG) used to treat bladder urothelial~     cell carcinoma.~   "
103885|NCT02207595|"~     The primary objective of this study is to investigate the safety and tolerability of UCB5857.~   "
103886|NCT02207582|"~     Transcranial random noise stimulation is used to stimulate the prefrontal cortices in~     patients with depression. It's a placebo-controlled two-arm study.~   "
103887|NCT02207569|"~     The study objectives are to assess the safety and efficacy of the CoreValve Evolut R~     transcatheter aortic valve replacement (TAVR) system in patients with severe symptomatic~     aortic stenosis are considered at high or extreme risk for surgical aortic valve replacement.~   "
103888|NCT02207556|"~     In this study the investigators want to find out more about the addition of the antibiotic,~     doxycycline, to standard anti-amyloid therapy in people with amyloidosis. The investigators~     want to find out whether doxycycline improves the response to standard anti-amyloid therapy~     and whether it causes any problems (side effects).~   "
103889|NCT02207543|"~     The proposed work is part of a multidisciplinary approach to continuity of care in the~     particular context of the palliative phase of cancer. In conducting this study, we would like~     to characterize, at the regional level, satisfaction with the care of patients and their~     families in their care home situations palliative cancer. This evaluation will be based on~     questionnaires adapted versions in French language satisfaction questionnaires recently~     validated for patients in palliative situation and supported home care.~      It will also identify the challenges faced by both patients, caregivers attending physicians.~      The evaluation of these elements is a prerequisite to propose ways of improving at a hospital~     palliative care for output relay and anticipate the coordination of care for optimal care of~     the patient at home, to meet the expectations of different stakeholders, or even prevent~     certain readmissions avoidable.~   "
103890|NCT02207530|"~     Primary Objective: To assess the efficacy of MEDI4736 monotherapy in terms of ORR~   "
103891|NCT02207517|"~     CITT-ART is a multicenter study (8 locations around the United States) of 324 children ages 9~     to <14 years with symptomatic convergence insufficiency (CI). The purpose of this study is to~     see if office-based therapy for convergence insufficiency (CI) improves reading ability and~     attention. CI is an eye-teaming problem where the eyes would like to drift outward when~     reading or doing close work. When eyes drift out, double vision can happen. To prevent double~     vision one must use extra effort to keep the eyes from going out. This extra effort can cause~     symptoms that can interfere with reading and working comfortably at near. These symptoms~     often include eyestrain, blurred vision, headaches, double vision, and loss of place when~     reading or performing tasks at near. In a prior study we found that therapy improves these~     symptoms. In this study we are looking at whether the therapy improves reading and attention~   "
103895|NCT02207465|"~     The investigators hypothesize that intensification of local therapy will lead to improvements~     in local control and survival in patients with unresectable and borderline resectable~     pancreatic cancer. The investigators propose to do this by combining nab-paclitaxel~     concurrently with dose-escalated radiation therapy. In the first part of this phase I study~     (sub-trial 1), the nab-paclitaxel dose will be escalated while the radiation dose is held~     constant at a standardly accepted level. The use of this novel chemoradiotherapy regimen will~     take advantage of nab-paclitaxels specific anti-tumor and anti-stromal properties, which may~     enhance the efficacy of radiation therapy, and thereby improve local control. After the MTD~     of nab-paclitaxel had been determined, in the second part of this study (sub-trial 2), the~     investigators will administer nab-paclitaxel at the determined MTD concurrently with~     escalated doses of radiation. The investigators will utilize a combination of protons and~     IMRT to safely deliver high doses of radiation while maximally sparing surrounding normal~     tissue. Patients will also preferentially have 2-3 fiducial markers placed in or around the~     tumor for daily localization and will be treated at breath hold in order to prevent tumor~     movement with normal respiration. Such a technique will help minimize target volumes and~     thereby avoid critical normal structures. The investigators will use gemcitabine and~     nab-paclitaxel before and after chemoradiotherapy given its promising results in metastatic~     pancreatic cancer patients. Correlative tissue and serum biomarkers are an important, but~     optional, part of this study.~   "
103896|NCT02207452|"~     This protocol describes the investigation of the use of hyperpolarised helium magnetic~     resonance imaging (MRI) in reflecting the regional differences in lung function of moderate~     to severe Chronic Obstructive Pulmonary Disease (COPD) patients.~      Since finalisation of the original protocol, new medications for COPD have received Market~     Authorisation Approvals. Protocol Amendment 02 has been prepared to include these medications~     in the protocol eligibility criteria and restrictions for the study.~   "
103897|NCT02207439|"~     This is a Phase II trial of definitive chemoradiotherapy (CTRT) given with the protease~     inhibitor,Nelfinavir (NFV), in patients with locally advanced head and neck. Eligible~     patients will receive a lead-in period of Nelfinavir (1250 mg po bid) for 7-14 days prior~     to initiation of CTRT. Nelfinavir will then be given concurrently with platinum-based~     chemotherapy and radiation therapy (planned total dose of 70 Gy over 7 weeks).~   "
103898|NCT02207426|"~     This study compares pharmacokinetic profiles of tobramycin delivered by TobrAir® 6.0 device~     with TOBI® nebulizer system and the TOBI® Podhaler™ device. In addition, lung deposition of~     tobramycin delivered by TobrAir® 6.0 device and by TOBI® nebulizer system will be determined.~   "
103899|NCT02207413|"~     The purpose of this trial is to demonstrate the acceptable safety profile and the~     immunological non-inferiority of the FLU D-QIV vaccine manufactured with this investigational~     process (FLU D-QIV Investigational Process [IP]) compared to FLU D-QIV manufactured with the~     current licensed process (FLU D-QIV Licensed Process [LP]).~   "
103900|NCT02207400|"~     This study will compare the Gingival Bleeding and Gingival Inflammation following twice daily~     use of a sodium bicarbonate experimental dentifrice compared to a 0% sodium bicarbonate~     toothpaste after 24 weeks of use. The study will be conducted at Salus Research, Inc.~     Participants will be recruited from their database and by use of an external recruitment~     agency~   "
103901|NCT02207387|"~     This study will investigate the effects of a contingency-based musical walking intervention~     program called Ambulosono on neural mechanisms in the brain. The investigators will~     investigate the long-term impact of Ambulosono on brain plasticity with functional MRI~     technique. Participants will undergo 3 months of Ambulosono training and their pre-training~     and post-training fMRI brain scans will be compared to understand the neural networks and~     brain mechanisms following this intervention. The investigators hypothesized that Ambulosono~     may induce functional compensatory reorganization of neural networks in the brain. This~     project will allow us to address the important potential confound of placebo influence and to~     aid in optimizing this intervention program. Additionally, the investigators are hoping to~     investigate the synergistic effects of rasagiline and exercise; the investigators' hypothesis~     is that there will be a positive synergistic effect, and that exercise will augment the~     effectiveness of rasagiline in treating Parkinson's symptoms.~   "
103902|NCT02207374|"~     This trial is conducted in Asia. The aim of the trial is to investigate safety and efficacy~     of semaglutide once weekly in monotherapy or in combination with one OAD (oral anti-diabetic~     drug) in Japanese subjects with type 2 diabetes who are insufficiently controlled on~     diet/exercise therapy or OAD monotherapy.~      All subjects will continue their pre-trial treatment (diet and exercise therapy or OAD~     monotherapy in addition to diet and exercise therapy) during the trial.~   "
103903|NCT02207361|"~     Paclitaxel plus Epirubicin in metastatic breast cancer is a recommended scheme in National~     Comprehensive Cancer Network (NCCN) guideline. Paclitaxel in Combination with Carboplatin is~     also effective in Metastatic Breast Cancer (MBC) in some clinical study with small sample.~   "
103904|NCT02207348|"~     This trial is conducted in Europe. The aim of this trial is to investigate bioequivalence~     between single-dose liraglutide administered subcutaneously with two different pen-injectors.~   "
103905|NCT02207335|"~     Gemcitabine plus carboplatin in recurrent or metastatic breast cancer is a recommended scheme~     in National Comprehensive Cancer Network (NCCN) guideline. gemcitabine in combination with~     capecitabine is also effective in Metastatic Breast Cancer (MBC) in some clinical study with~     small sample.~   "
103906|NCT02207322|"~     The main purpose of this study is to assess whether early integration of palliative and~     supportive care services in care of patients hospitalized for hematopoietic stem cell~     transplantation (HSCT) can improve patients' and family caregivers' quality of life and mood.~   "
103907|NCT02207309|"~     This trial compares pazopanib to placebo as maintenance treatment over 2 years in patients~     with retroperitoneal and visceral high-risk soft tissue sarcomas after multimodal treatment~     including prior neo- and/or adjuvant doxorubicin / ifosfamide chemotherapy with regional~     hyperthermia.~   "
103908|NCT02207296|"~     The purpose of this study is to determine whether an operative hemodynamic optimization using~     the plethysmographic variability index during orthopedic surgery could decrease the length of~     hospital stay and the postoperative morbidity.~   "
103913|NCT02207218|"~     This study is conducted in Asia. The aim of this study is to evaluate the safety and efficacy~     of NovoEight® (recombinant factor VIII) in patients with haemophilia A in Japan in the~     setting of routine clinical practice.~   "
103915|NCT02207192|"~     Postural changes are known to affect normal lung volumes. A reduction in sitting to supine~     functional residual capacity (FRC) is well-described in non-obese subjects adopting a supine~     position. However, postural changes in lung volumes in the obese require further exploration.~     We aimed to longitudinally address the effects of weight loss on postural changes in lung~     volumes and pulmonary function, in obesity. We tested the hypothesis that supine reduction in~     FRC would be absent in morbid obesity and recovered upon weight loss.~   "
103916|NCT02207179|"~     This study will evaluate LumaScan, an innovative polarization microscope for real time,~     intraoperative imaging and evaluation of the surface of excised tissue excised during Breast~     Conservation Surgery (BCS) for non invasive and invasive breast cancer. The investigators~     hypothesis is that LumaScan will be comparable for cancer detection to conventional~     histopathologic evaluation of the same areas of breast tissue. The real time, intraoperative~     images provided by LumaScan will help improve BCS and lessen the need for BCS re-excision~     surgeries which can lead to higher cost, poor cosmetic outcomes, reduced survival rates, and~     loss of confidence in the tissue conservation surgery procedure.~   "
103917|NCT02207166|"~     Medical devices are designed and manufactured by subjective design process that was only~     based on engineers' direct concepts to essential principles sets for the device. A home user~     may not easily use or operate the piece of medical device through the interfacing components~     as the designer's expected such as the meaning when pushing a button or switching a knob,~     even the required procedure needed when a certain display shown to fulfill some knowledge~     dependent judgment. In addition, the incompatible interfacing designed communication between~     a user and the device may cause possible errors that may trigger further negative~     consequences during the use of the device to a innocent home user.~      The aim of this research is to closely understand the consequent results of human factor~     engineering or usability engineering practices of various types or models of marketed~     home-use blood pressure monitors (BPM) in real use.~   "
103918|NCT02207153|"~     Patients undergoing chronic dialysis are at a substantially increased risk of cardiac death.~     The reasons for this excess cardiovascular mortality are only partly understood. Classical~     complicated artherosclerotic disease does not appear to be the primary cause of cardiac death~     in chronic dialysis patients. In fact, the predictive potential of classic cardiovascular~     risk factors such as hypertension, obesity and hyperlipidemia appears to be reduced in~     dialysis. In contrast, in a series of pilot studies we found cardiac biomarkers to adequately~     reflect dialysis induced myocardial stunning, progressive cardiovascular disease, and the~     risk of death.~      To extend and corroborate these results, we are planning a large, prospective, observational~     study enrolling unselected hemo- and peritoneal dialysis patients. The proposed study, its~     power calculation and hypotheses are based on our pilot studies~   "
103919|NCT02207140|"~     The study is randomized, double-blinded and placebo-controlled with a duration of 24 weeks.~     Following randomization, healthy elderly are randomized into two groups receiving probiotics~     or placebo. Fecal samples are collected before and after the study. The samples are~     investigated for Clostridium difficile levels, changes in diversity of the gut microbiota as~     well changes in the fecal metabolome. The effects of the produced metabolites on~     mitochondrial activity will moreover be investigated using selected intestinal cell lines.~   "
103920|NCT02207127|"~     There is a fundamental gap in the investigators ability to design effective surgical~     treatment of obstructive sleep apnea (OSA) for the 30-40% of patients who cannot tolerate~     non-surgical treatment. OSA surgery outcomes vary widely, with the chances of a successful~     outcome ranging from 5% to 65% for individual or combination procedures. To predict - and~     thereby to improve - outcomes, the investigators must determine what predicts surgical~     success. This project will compare findings from two evaluations: drug-induced sleep~     endoscopy (DISE) and upper airway magnetic resonance imaging (MRI). DISE has demonstrated~     important benefits, but it has important limitations. Upper airway MRI is the most complete~     evaluation performed during wakefulness, making it conducive to broad application and less~     expensive than DISE, but there are no studies utilizing MRI as a surgical evaluation. The~     investigators propose a cross-sectional analysis of 40 adult subjects with moderate to severe~     OSA. In addition to history, physical examination, and polysomnogram (sleep study), all~     subjects will undergo DISE and MRI to characterize the pattern of obstruction. The~     investigators will examine the association between DISE and MRI, focusing on specific DISE~     findings that have been associated with surgical outcomes. The investigators~     multidisciplinary team has substantial expertise and experience in OSA investigation, DISE,~     and upper airway MRI.~   "
103921|NCT02207114|"~     The proposed work will provide critical insights into the potential impact of a~     biomarker-based algorithm on reducing unnecessary antibiotic use in different adult and~     pediatric/neonatal ICU's. This proposal will also assess the costs (or savings) of a~     biomarker-based intervention. Overall, the results of this work will be critical in informing~     future strategies to eliminate unnecessary antibiotic use and curb the continued rise in~     antimicrobial resistance.~   "
103922|NCT02207101|"~     Young athletes are usually regarded as a special subgroup of healthy individuals with a~     unique lifestyle who are apparently invulnerable and often capable of extraordinary physical~     achievement. Most athletic disciplines to some extent combine endurance and strength modes of~     physical conditioning. Acute responses to endurance exercise training include substantial~     increases in maximal oxygen uptake, cardiac output, stroke volume, and systolic blood~     pressure in-spite of this, high intensity chronic training such as marathons, very long~     distance bicycle racing etc., can lead to transient acute volume overload of the atria and~     right ventricle, with transient reductions in right ventricular ejection fraction and~     elevations of cardiac biomarkers. Although these biomarkers generally normalize back within~     seven to ten days, these transient changes may sooner or later mark the beginning of~     processes like patchy myocardial fibrosis finally leading to grave chronic heart diseases .~      Inspite of the awareness regarding the cardio vascular risk in the athletes, there have been~     no new advancements in finding an alternate option which can protect the cardio vascular~     system in the athletes.~      Hence in order to address the need of the hour and also to avoid the cardio vascular risk in~     athletes along with improvising the endurance capacity, Enovate Biolife is in the process of~     development of an innovative product E-OJ-01.~      E-OJ-01 is expected to have beneficial effects on the cardio vascular system of the athletes~     by enhancing ejection fraction which in turn improves cardiac output. This finally is~     hypothysed to increase the maximal oxygen uptake capacity in athletes.~   "
103923|NCT02207088|"~     This open-label study will evaluate safety, pharmacokinetics and efficacy of a 12 or 24-week~     regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in~     HCV-genotype 1-infected subjects with an Estimated Glomerular Filtration Rate (eGFR) <30,~     including those on hemodialysis or peritoneal dialysis.~   "
103924|NCT02207075|"~     This is pilot study designed to quantifying the innate immune inflammatory burden in a cohort~     of secondary progressive multiple sclerosis subjects. Innate immunity is recognized as a~     major cause of tissue injury in central nervous system (CNS) disease. Our hypothesis is that~     the innate immune response is heightened in SPMS as compared to healthy controls (HC's) and~     this activity increases over time and correlates with ongoing neuronal loss and disability.~     The investigators will test this hypothesis by using highly specific molecular imaging~     techniques, specifically PET, in conjunction with high field MRI. The investigators will~     utilize the PET radioligand [11C]PK11195 which will be used as a marker of activated~     macrophages/microglia. The investigators will correlate [11C]PK11195 uptake with conventional~     measures of inflammation and neuronal integrity on high-resolution MRI.~      SPMS subjects will have two baseline [11C]PK-11195 PET scans (separated by 24 to 72 hours,~     test-retest) and subsequent scans at 6, 12 and 24 months. SPMS Subjects will have brain MRI's~     at baseline, 6, 12 and 24 months.~      Healthy Controls will have 2 baseline PET scans and one MRI.~   "
103925|NCT02207062|"~     This pilot clinical trial studies ibrutinib in treating patients with transformed indolent (a~     type of cancer that grows slowly) B-cell non-Hodgkin lymphoma that have returned after a~     period of improvement or do not respond to treatment. Ibrutinib may stop the growth of cancer~     cells by blocking some of the enzymes (proteins) needed for cell growth.~   "
103926|NCT02207049|"~     The purpose of this pilot study will be to examine the influence of providing snacks on~     consumption of overall energy intake in children aged 2-5 years in the Early Learning Center~     (ELC) at the University of Tennessee.~   "
103927|NCT02207036|"~     This randomized clinical trial will test the efficacy of a Facebook intervention based on the~     Transtheoretical Model (Prochaska and DiClemente) and US Public Health Service Clinical~     Practice Guidelines with young adults who smoke cigarettes who are age 18 to 25 (N=480).~   "
103928|NCT02207023|"~     The purpose of this study is to examine the efficacy of a lifestyle modification telehealth~     program on health-related behaviours in community-dwelling individuals living with stroke.~   "
103929|NCT02207010|"~     This study would test how much of the new drug, AZD1775, is present in tumor, blood, and skin~     after one dose of the drug.~      The purpose of the study is not to treat the tumor, but to see if the drug actually gets into~     the tumor cells. This study does not replace routine cancer treatment.~   "
103930|NCT02206997|"~     The aim of the study is to evaluate a patient prewarming concept following the~     recommendations of the S3-guideline Prevention of perioperative hypothermia with respect to~     incidence and complications of perioperative hypothermia. The study hypothesis is that~     postoperative core temperature in adult patients after prewarming is significantly higher~     than in patients who were treated following actual standard protocol (passive insulation).~   "
103931|NCT02206984|"~     RATIONALE: Currently, adjuvant endocrine therapy often follows a one-size-fits- all~     approach, with most premenopausal women receiving tamoxifen, and most postmenopausal~     receiving aromatase inhibitor therapy. In current clinical practice, patients with invasive~     lobular carcinoma are treated no differently than patients with invasive ductal carcinoma~     based on the void of information specific to patients with this tumor type. Identification of~     a biological signal of tamoxifen and/or AI-resistance and/or fulvestrant-sensitivity in ILC~     patients would have dramatic implications for the future management of this breast cancer~     subtype.~      PURPOSE: To study whether fulvestrant is more effective than anastrozole or tamoxifen in~     reducing Ki67 in ILC and whether that Ki67 reduction will correlate with alterations in~     expression of ER and ER-regulated genes. Differential Ki67 effect in this study will serve as~     a surrogate for outcome of ILC patients on endocrine therapy.~      Primary Objective:~      To determine the change from baseline to post-treatment Ki67 values in ER-positive,~     HER2-negative ILC tissue derived from postmenopausal women awaiting definitive surgery or~     further neoadjuvant treatment who are randomized to 21-24 days of neoadjuvant endocrine~     treatments with fulvestrant (two 250 mg IM injections given on day 1), anastrozole (1mg given~     orally daily), or tamoxifen (20mg given orally daily).~   "
103932|NCT02206971|"~     The purpose of this study is to examine the impact of providing light smokers with feedback~     about their health, including exposure to tobacco-related chemicals.~   "
103933|NCT02206958|"~     Study Aim:~      To determine the feasibility and treatment effect of a multi-component intervention combining~     non-drug treatments for urinary incontinence, physical activity, and environmental~     modifications to prevent toileting disability in frail older women living in senior housing~     facilities.~      Hypothesis 1:~      Treatment group participants will have a 15% improvement in toileting skills as measured by~     the performance on timed toileting instrument compared to no improvement in women assigned to~     the no treatment group~      Hypothesis 2:~      Treatment group participants will have improvements in urinary incontinence severity and~     frequency, quality of life related to urinary incontinence, physical function, and barriers~     to toileting compared to no improvement in the no treatment group participants~   "
103934|NCT02206945|"~     The aim of this study is to train patients with obsessive-compulsive disorder to control a~     region of their brain that has been associated with their symptoms. Patients in the~     experimental group will be given direct feedback regarding activity in this brain area while~     they are undergoing functional magnetic resonance imaging (fMRI) scanning, and will try to~     learn to control activity in the region during these feedback sessions. A separate group of~     patients will be given a control form of feedback that we do not believe can have clinical~     benefits. Our primary hypothesis is that the neurofeedback training will reduce OCD symptoms~     more than the control feedback.~   "
103935|NCT02206932|"~     This is a study of the safety and effectiveness of the hepatitis C medications sofosbuvir and~     simeprevir in patients who have both the HIV and hepatitis C (HCV) viruses.~   "
103969|NCT02206490|"~     Veterans of the 1991 Gulf War who developed Gulf War Illness are being studied. Treatments~     with FDA approved generic drugs are being administered to see if they help with the symptoms~     of Gulf War Illness, such as chronic fatigue; difficulty with memory, concentration, and~     thinking; widespread chronic pain; and autonimic dysfunction. Drugs to be tested are~     dextromethorphan and naltrexone.~   "
103936|NCT02206919|"~     A major function of blood vessels is to control blood flow by dilating or constricting~     depending on the demand. Vascular dysfunction is a state in which blood vessels fail to carry~     out its normal roles such as regulating blood flow. Diabetes is a risk factor for vascular~     dysfunction. Dysfunction may involve the smaller and/or larger blood vessels. Failure in the~     ability of large (conduit) blood vessels to control blood flow may be an early feature of~     atherosclerosis, a leading cause of stroke and heart attack. Measures of blood vessel~     dilation give an indication of the health of the vessel. Ultrasound and MRI can assess~     vascular function by measuring changes in blood vessel dilation. Diabetes may also affect~     tiny vessels in the kidney. These vessels become porous allowing albumin (a protein in the~     blood) to leak into the urine. The investigators can easily measure the presence of albumin~     in the urine.~      This study aims to explore if MRI can demonstrate an association between vascular health in~     tiny and larger (conduit) blood vessels, by testing for an association between blood flow~     regulatory capacity of large vessels and presence of albumin in the urine.~   "
103937|NCT02206906|"~     Medication adherence is one of the most salient predictors of patient outcomes in the era~     following development of effective treatment for HIV infection. Evolving strategies to~     improve adherence, specifically incentive interventions and real-time medication monitoring,~     have shown some success in limited studies. Further investigation into incentive~     interventions for HIV-infected adolescents with poor medication adherence is necessary.~   "
103938|NCT02206893|"~     Introduction Chronic disease is prevalent and costly in the U.S. (Tu & Cohen, 2009). Poor~     eating habit is one factor that account for risk of chronic disease (Arsand, Varmedal, &~     Hartvigsen, 2007). Smartphone technology has been promising to improve preventive health~     outcomes. However, its great potential has not been widely applied to people's eating~     behaviors and its impact is unknown.~      Professional and peer supports can improve health status (Elkjaer et al., 2010; Lorig et al.,~     1999; Perri, Sears, & Clark, 1993). However, the former is usually delivered didactically or~     passively with limited use of smartphones. There is also little evidence of the effect of~     peer support delivered by smartphones in the domain of healthy eating. This research aims to~     study what smartphone technology can do to upgrade professional and peer supports, and to~     evaluate the impact of these mobile-app enabled supports on people's behavior of healthy~     eating and user engagement.~      Hypotheses~      According to Social Cognitive Theory, we hypothesize the following:~        1. Mobile-enabled self-monitoring approach improves users' healthy eating behaviors through~          improved self-efficacy~        2. Professional support improves users' healthy eating behaviors through improved~          self-efficacy~        3. Peer support improves users' healthy eating behaviors through improved self-efficacy~        4. The amount of support is positively correlated with the change in behaviors and their~          determinants~      Experiment Design The hypotheses will be examined bya 4-month randomized field experiment.~     375 subjects will be recruited and assigned to one of the five arms to receive the~     corresponding tool for diet management at no cost.~      Arm 1: a mobile App with both professional and peer support Arm 2: a mobile App with peer~     support only Arm 3: a mobile App with professional support only Arm 4: a mobile App without~     any support Arm 5: a non-mobile web App In addition to the App usage data, five surveys are~     conducted at baseline and the end of each month. Respondents will be compensated by $8 and a~     chance to win $200 for each completed survey.~      Interventions~        1. All subjects receive the following interventions: an education package includes the~          importance of healthy eating, concept of MyPlate, personalized daily food plans;~          reminders throughout the study; goal setting capabilities;~        2. Self-monitoring provided by an Android App: a heuristic approach inspired by MyPlate to~          record their food consumption which allows users to record their meals by images and~          doesn't require estimations in cups and ounces; daily reports and trend reports~        3. Self-monitoring provided by the web App: a traditional approach to record their food~          consumption which requires estimations in cups and ounces, and no images are allowed; no~          daily reports and trend reports are provided~        4. Professional support provided by a registered dietitian via the Android App: the~          supports include the following:~             1. Reply to users' messages regarding healthy eating~             2. Provide meal-specific comments on subjects' meal consumptions: one meal per week~             3. Provide feedback on the subjects' consumption patterns: once per week~        5. Peer support provided by other subjects via the Android App: the App provides platforms~          for subjects who have the same interest to communicate to each other. The actions the~          subjects can do in the platforms include:~             1. Post images or texts related to healthy eating~             2. Share meals with their ratings~             3. Like/dislike others' posts~             4. Comment on others' posts e Create groups which allow subjects who have the same~               interest to join~      Measurements~        1. Dependent Variables~             1. Eating behavior: a score of healthiness of a meal will be assigned by a dietitian.~               The scores obtained by the same subject along the experiment compose the subject's~               eating behavior~             2. Engaging behavior: this is measured by the number of meals recorded by the subject~               in a week. The numbers for the same subject along the experiment compose the~               subject's engaging behavior~        2. Independent Variables~             1. Level of peer support: this will be measured by a score representing the number of~               posts, likes, and comments received and given by a subject in a week~             2. Level of professional support: this will be measured by a score representing the~               number of messages or comments exchanged with the dietitian in a week~        3. Mediator Variables: self-efficacy, outcome expectation, and impediments will be measured~          by survey instruments~      Data~        1. User Survey: characteristics and perceptions~        2. Mobile App: time, location, and contents of goal setting, meal entries, communications~          with professionals and peers~        3. Web App: contents of goal setting and meal entries~      Analysis Confirmatory factor analysis and statistical modeling such as structural equation~     modeling and mixed models will be conducted to test our hypotheses.~   "
103939|NCT02206880|"~     Delirium is a prevalent complication following cardiac surgery that is under-recognized using~     current methods of delirium detection and that may be better identified through a systematic~     and standardized perioperative screening protocol.~      The purpose of this study is to determine the incidence of postoperative delirium in the~     current era of cardiac surgery using a validated delirium-screening tool.~   "
103940|NCT02206867|"~     To compare PK, safety and tolerability of LBAL developed by LG Life Sciences Ltd. With those~     of Humira®.~   "
103941|NCT02206854|"~     For previous clinical trials, R-flurbiprofen has been prepared in tablet form. In this study~     R-flurbiprofen, will be available as gelatine capsules.~      This study aims to show the bioavailability of R-flurbiprofen when administered in gelatine~     capsules. The serum availability will be determined by analysis of pharmakokinetic (pK)-blood~     samples at different time points. To assess the safety of the administered capsules adverse~     events will be documented.~      Analysis of lipid signaling molecules in plasma will be done to assess the role of this~     molecules as variable for therapeutic effects.~   "
103942|NCT02206841|"~     This study is designed for establishment of non-alcoholic fatty liver disease patients cohort~     to development of markers to predict histologic progression of liver fibrosis.~   "
103943|NCT02206828|"~     The aim of this Observational Registry Study is to assess the short- and long-term~     clinicaloutcomes following the use of Symbotex™ Composite Mesh in primary and incisional~     abdominal wall hernia surgeries by open or laparoscopic approach, according to the~     Instruction for use (IFU).~   "
103944|NCT02206815|"~     The aim of this study was to assess safety of antithrombotic drug ticagrelor plus oral~     anticoagulation adopted in persistent or permanent AF(Atrial fibrillation)~     patients（CHA2DS2VASc≥2） after PCI-S with specially regard to the occurrence of major bleeding~     complications. We hypothesized that baseline characteristics (ie age, anemia, previous major~     bleeding) and type of antithrombotic regimen could influence any bleeding events and the time~     of bleeding occurrence. We will test this hypothesis by comparing those AF patients who~     subsequently received double antithrombotic therapy (Ticagrelor + Warfarin) vs. triple~     antithrombotic therapy (Clopidogrel + Aspirin + Warfarin) after undergoing PCI-S.~   "
103945|NCT02206802|"~     The primary purpose of this study is to evaluate the clinical validity of the minoxidil~     response in-vitro diagnostic kit.~   "
103946|NCT02206789|"~     Aim/ Objective: Study consists of 2 separate and distinct entities A. Evaluation of the~     efficacy of 2% cyclosporine in preventing graft rejection in primary grafts w/o high risk~     characteristics study 1 (PKP study) B. Evaluation of the efficacy of 2% cyclosporine in~     preventing graft rejection in therapeutic keratoplasty- study 2(TKP study) Materials &~     Methods: In both arms Patients requiring keratoplasty, above the age of 18 whom~     satisfactorily meet The inclusion criteria are different for each study Eligible candidates~     will be enrolled after signing an Informed Consent form Patients will be randomized into one~     of 2 groups~        -  Only on topical steroids group A~        -  On topical steroids + 2% cyclosporine Group B Study design: Prospective, randomized~          non-blinded study at a single centre. Methodology In both arms~           1. Schedule of topical steroid administration : 6 times for 2 weeks; 5 times for 2~          weeks; 4 times for a month; 3 times for a month, and, subsequently twice-a-day until 1~          year is completed Systemic steroids may be administered in the initial 2 weeks at the~          discretion of the investigators. (For all patients with fungal keratitis topical~          steroids can preferrably be administered only after 2 weeks post keratoplasty.) Until~          then voveran ophtha may be used~           3. Patients randomized to receive 2% cyclosporine will receive the same 3 times a day~          for 2years~           4. All patients will be followed for a minimum period of 2 years~           5. Follow up schedule - at 1 week, 2 weeks, 1 month, 2 months, 3 months, then every 3~          months until 2 years are completed~           6. All episodes of graft rejection will be treated as per accepted norms and the patient~          will no longer follow the standardized protocol for steroid administration~   "
103947|NCT02206776|"~     Obsessive-compulsive disorder (OCD) is a common illness that causes significant distress and~     impairment. Currently, serotonin reuptake inhibitors (SRIs) are the only medications that are~     FDA-approved to treat OCD. Unfortunately, SRIs can take a long time to work (2-3 months), and~     even then they usually only partially reduce OCD symptoms. The present study, will test if~     intranasal ketamine is feasible to use and can reduce OCD symptoms significantly more than a~     comparison medication called midazolam. Therefore, you may or may not receive ketamine as~     part of this study. Results from this study will allow doctors and researchers to better~     understand if you and others with OCD may respond to this class of medications.~   "
103976|NCT02206399|"~     The investigators clinical trials will be for a medical device that is non-invasive in~     nature. The investigators will be studying whether their non-invasive medical device gets~     data that is as good as, or better than, an FDA previously approved, blood analysis device.~     There is no study hypothesis for this study.~   "
103948|NCT02206763|"~     This study will evaluate the safety, preliminary efficacy, and pharmacokinetics (PK) of~     momelotinib (MMB) and erlotinib, as well as define the maximum tolerated dose (MTD) of~     momelotinib (MMB) combined with erlotinib in adults with epidermal growth factor receptor~     (EGFR)-mutated, EGFR tyrosine kinase inhibitor (TKI) naive metastatic non-small cell lung~     cancer (NSCLC). Participants will be sequentially enrolled to receive progressively~     increasing doses of MMB in combination with erlotinib. Escalation of MMB doses will proceed~     to the MTD, defined as the highest tested dose associated with dose-limiting toxicities (DLT)~     during the first 28 days of combined erlotinib and MMB treatment. There will be four dose~     levels and each treatment cycle will consist of 28 days.~   "
103949|NCT02206750|"~     Purpose:~      The purpose of this protocol is to understand how social factors such as psychosocial stress~     may modify how people respond to air pollution. Ultimately this will help us understand~     health disparities from poor air quality.~      Participants:~      Up to 40 healthy adults,18-33 years old with different perception of stress will participate~     and complete this study.~      Procedures (methods):~      Subjects will be exposed to clean air and to ozone ( 300ppb) for 2 hours in a controlled~     environment chamber. Cardiac, vascular, pulmonary and cognitive function will be evaluated~     pre, immediately post and 18 hr post exposure.~      The primary endpoint will be Heart Rate Variability . Secondary endpoints will include~     pulmonary function, analysis of blood clotting/coagulation factors, biomarkers of stress,~     cognitive function, radial artery pulse wave measurements and analysis of soluble factors~     present in plasma.~   "
103950|NCT02206737|"~     Cigarette smoking is associated with poor wound healing and worse results after hand surgery.~     Nicotine and cigarette smoke has been shown to affect blood flow in blood vessels in the~     hand.~      Patients are increasingly using electronic cigarettes (e-cigarettes) as a method of quitting~     smoking. E-cigarettes consist of a replaceable nicotine cartridge, a heating element and a~     battery source. They are able to deliver vaporised nicotine in the absence of other~     ingredients found in normal cigarettes such as tar and carbon monoxide.~      Although e-cigarettes lack a lot of the harmful ingredients of regular cigarettes, nicotine~     still has toxic effects on the body. Nicotine causes the release of chemicals within the body~     that act to reduce blood flow in small blood vessels of the hand.~      E-cigarettes remain a controversial topic among healthcare professionals due to the lack of~     research surrounding them. A recently published literature review identified only three~     significant studies into the effects of smoking e-cigarettes. All of these studies showed the~     harmful effects of e-cigarettes on the lungs but to date, there is no published research~     investigating the effects of e-cigarettes on the blood flow within the small blood vessels of~     the hand.~      Currently, we advise patients to quit smoking after they sustain a hand injury to improve~     healing and recent research suggests that patients should be advised to quit smoking 4 weeks~     before routine hand surgery. However, there is no guidance on whether we should also advice~     patients to refrain from using e-cigarettes for this time period.~      Our aims are to answer the following questions:~        1. Do electronic cigarettes have any effect on the blood flow in the hand?~        2. Do we need to give cessation advice to patients with hand injuries who smoke electronic~          cigarettes?~   "
103951|NCT02206724|"~     The investigators aim to test the safety and feasibility of prostate gland stereotactic body~     radiotherapy (SBRT) plus best systemic therapy in newly diagnosed metastatic prostate cancer.~   "
103952|NCT02206711|"~     The purpose of this study is to assess the pharmacokinetics (PK), metabolism, routes and~     extent of elimination, safety and tolerability of a single oral dose of [14C] BMS-955176 in~     healthy male subjects. There is no formal research hypothesis to be statistically tested for~     this study.~   "
103953|NCT02206698|"~     The submitted proposal is designed to reduce morbidity and mortality to injured children.~     Significant variability in the initial trauma assessment exists among institutions. The~     proposed project is a prospective, observational, multi-institutional study of children~     following blunt abdominal trauma. The specific goals of the project are to: 1) Document~     history, physical exam findings, imaging, and laboratory values, which are available to~     physicians during the initial trauma resuscitation prior to a decision on whether to order an~     abdominal computed tomography (CT) to evaluate for potential intra-abdominal injury; and 2)~     Derive and validate a multi-variable clinical prediction rule based on data variables readily~     available during the pediatric trauma resuscitation to identify patients at low risk for~     intra-abdominal injury, in which unnecessary CT might safely be avoided. Information from~     this study could be used to develop a more standardized approach to the evaluation for~     intra-abdominal injury following blunt trauma in children. This information could lead to~     significant improvement in the early recognition of injury and to improved resource~     utilization.~   "
103954|NCT02206685|"~     Scoliosis is a disease that involves lateral and/or rotational deformity of the spine and can~     affect up to 4% of the population. Typically, surgery is considered when Cobb's angle, which~     is a measurement used for evaluation of curves in scoliosis on an anterior-posterior~     radiographic projection of the spine, is greater than 50 degrees in the thoracic region (40~     degrees in the lumbar region) or when the curvature causes significant pain, or respiratory~     and cardiovascular restriction. Patient undergoing this surgical correction experience severe~     pain in the postoperative period and the management includes the use of opioid-based~     patient-controlled analgesia (PCA).~   "
103955|NCT02206672|"~     This prospective single-center study evaluates a current care procedure. It includes 14~     patients diagnosed with SSc according to the ACR/EULAR criteria or the Leroy & Medsger~     criteria of the disease. Patients are enrolled if they wish for a therapeutic care of their~     face, have a Mouth Handicap in Systemic Sclerosis (MHISS) score greater than 20 (scale 0-48),~     a modified Rodnan skin score upper or equal to 1 on the face (scale 0-3), and a mouth opening~     less than 55 millimeters. They should not have anticoagulant, anti-platelets aggregation~     medication or a daily steroid dose upper 20mg per day. Their BMI should exceed 17.~      Micro fat grafting is a minimally invasive and usual procedure performed under local~     anesthesia. Fat tissue is harvested (around 50 milliliters) using a 14 gauge or 2 mm diameter~     cannula from areas around the knees, the abdomen or the hips under a gentle aspiration.~     Lipoaspirated fat is then filtrated by the PureGraft system that offers a sterile, closed,~     single-use system, leading to a fast, consistent and controlled preparation. Then, 10 to 25~     milliliters of this purified fat product is transferred through a 21 gauge or 0.8 mm diameter~     cannula in two or four points of the face, with the entry points located around the mouth.~   "
103957|NCT02206646|"~     To monitor the safety of Metalyse® in clinical practice in patients with acute myocardial~     infarction over a period of 6 years as required by Korean authorities, with the following~     observations:~        1. Unexpected adverse drug reactions~        2. Frequency and nature of adverse events (AEs)~        3. Factors on the safety and efficacy profile of the Metalyse® Injection. Efficacy of~          Metalyse® was also assessed.~   "
103958|NCT02206633|"~     The study will aim to determine normal daily variation of the individual hydration level in~     longitudinal study on elderly in assisted living facility and assess a range of variation of~     individual hydration baselines for elderly in a normal physiologically hydrated state.~   "
103959|NCT02206620|"~     This study will compare the effects of placebo and donepezil, a drug that helps conserve~     concentrations of the neurotransmitter, acetylcholine on measures of balance and gait in~     subjects with Parkinson's disease (PD). This study is a double-blind, placebo controlled,~     cross-over randomized clinical trial. Short-latency afferent inhibition (SAI), a~     physiological index of cholinergic function will be measured to determine if the deficits in~     balance and gait correlate with abnormalities of the SAI and if SAI is altered by donepezil~     as a measure of drug efficacy. Cognitive tests like the attention network test will be~     administered to determine if changes in gait and balance are mediated by changes in~     attention.~      The results of this study will be the most direct test of the hypothesized role of~     cholinergic neurons and the neurotransmitter, acetylcholine in terms of gait and balance. The~     study is exploratory because it is not known whether donepezil will affect gait, balance or~     attention, nor which measures of gait, balance or attention will be sensitive to drug~     manipulation. The study's immediate goal is to determine the potential utility of cholinergic~     manipulation as a strategy for preventing or treating balance and gait dysfunction in PD. The~     findings of this trial are intended to lead to more sharply focused questions about the role~     of cholinergic neurons in balance and gait and eventually to Phase II B trials to determine~     clinical utility of cholinergic manipulation to prevent falls and improve mobility.~   "
103960|NCT02206607|"~     Study B1621015 will characterize bioavailability, tolerability and pharmacodynamics of three~     modified release formulations of PF-04937319 compared with the immediate release~     material-sparing-tablet (IR MST) formulation in adults with type 2 diabetes.~   "
103961|NCT02206594|"~     A pilot study designed to assess the feasibility of planned descemetorhexis for the treatment~     of Fuchs' corneal dystrophy.~   "
103962|NCT02206581|"~     The study will aim to evaluate the correlation between changes in ultrasound velocity and~     measures of hydration status including urine specific gravity, plasma and urine osmolality in~     male and female young adults after undergoing an acute dehydration and rehydration. The study~     will also test the hypothesis that body dehydration is a generalized physiological process~     equally affected all body muscles by comparing the data obtained on calf and biceps muscles.~   "
103963|NCT02206568|"~     To compare the early pharmacokinetic exposure of URAL and insulin lispro (ILisp).~   "
103964|NCT02206555|"~     Significant increases in HIV diagnoses among gay and other homosexually active men, in~     Australia and internationally, have been observed since the late 1990s. The levels of high~     HIV risk sexual practices among gay men have also increased, particularly unprotected anal~     intercourse (UAI). Nationally, over three quarters of the new HIV infections diagnosed~     annually are among men who have sex with men (MSM). The proportion of heterosexual men and~     women among those diagnosed with HIV annually has also increased in recent years. Despite~     successes in some situations, HIV transmission has not been adequately reduced by the~     prevention methods available to those at risk, such as education, condoms, and treatment of~     sexually transmitted infections (STIs).~      The effectiveness of daily oral antiretroviral medications (ARVs) as preexposure prophylaxis~     of HIV (PrEP) has now been established by clinical trials in both heterosexual adults and~     homosexual men. Whether PrEP confers high rates of protection in real life situations and is~     a feasible strategy to implement still requires further investigation. Through its HIV~     prevention strategy 2015: New era, NSW Health committed to consider how to most~     appropriately and efficiently implement PrEP in line with evidence. This commitment~     translated in the support to this PrEP demonstration project.~      This demonstration project is designed to evaluate the off-label provision of daily~     combination of tenofovir disoproxil fumarate and emtricitabine (TDF/FTC, known as TRUVADA) as~     PrEP to a sample of sero-negative individuals at high risk for HIV infection in clinical~     settings in New South Wales. The project will inform policy development regarding primary HIV~     prevention with PrEP.~      This is an open-label, single-arm treatment evaluation study. All consenting and eligible HIV~     negative participants will receive TRUVADA prescribed for daily administration orally. At~     each followup visit, the following procedures will be conducted: clinical evaluations/~     procedures, laboratory evaluations/ procedures, testing for HIV, STIs, hepatic and renal~     function, assessment for adherence to the prescribed medication, side effects, eligibility~     for next TRUVADA prescription, and willingness to continue on PrEP.~      As a study requirement, participants will be offered a self-administered assessment of~     behaviour, lifestyle and attitudes which will be conducted ideally within two and no more~     than seven days of the clinic visit in the participant's private space.~      Analyses will include: the feasibility of PrEP delivery, adherence to the study medication,~     safety and tolerability, the effects of PrEP use on behavior, and statistical analyses of the~     risk of HIV seroconversion.~   "
103965|NCT02206542|"~     Disability of upper limbs due to neurologic and orthopedic disorder or injuries is commonly~     seen clinically. For example paralysis or paresis of upper limb due to stroke is relatively~     prevalent, and it may result in severe muscle weakness, pain, contracture, spasticity and~     disability. These patients need early and regular rehabilitation to regain their function and~     prevent unnecessary complications such as contracture and disuse atrophy. Proper~     rehabilitation is important but the challenge is also great. However, rehabilitation training~     is a very labor-intensive task in which one to one treatment is essential and that will~     restrict the number of patients served. Moreover, patients receiving home programs are~     difficult to supervise, resulting in reduced training effect and delayed functional recovery.~     In order to reduce related cost (including time, personnel, facilities, and expense, etc.) of~     rehabilitation in hospitals or clinics, this Robot research team had developed a prototype of~     upper-limb exoskeleton rehabilitation robot and its related technology and human-robot~     interaction. This robot is used to serve the rehabilitation need of those patients suffering~     from upper extremities dysfunctions and also can provide careful designed therapeutic program~     of upper limbs including shoulder and elbow joint exercises. Its control software also~     provides a therapeutic management system with intelligence and ergonomic consideration. This~     work was funded by National Taiwan University Hospital (NTUH) since 2008 and has applied for~     both the U.S. and Taiwan (ROC) patents, where the latter has been approved in Nov. 2011. The~     clinical trial was firstly approved by Research Ethics Committee B of NTUH in 2009 and~     finally approved by Department of Health (DOH) in April 2011. This team had completed the~     clinical trial for healthy subjects and pre-clinical trial for stroke patients. Based upon~     this experience an innovative and intelligent SMART Robot Rehabilitation System for Frozen~     Shoulder Syndrome is proposed to prove its safety, efficacy, and cost-effectiveness.~   "
103966|NCT02206529|"~     The purpose of this study is to develop a Social Network Engagement (SNE) Intervention that~     will be integrated into a standard treatment program for childhood overweight. The~     investigators will conduct a pilot trial of SNE to assess feasibility and to estimate its~     effectiveness compared with historical controls who received standard treatment. The~     historical controls will be participants in the FOCUS trial (Family Overweight: Comparing Use~     of Strategies; NCT00746629).~   "
103967|NCT02206516|"~     This study aims at combining imaging techniques and clinical evaluations to assess clinical~     change as well as brain changes that occur as a result of brain stimulation in adult~     attention deficit disorder.~   "
103970|NCT02206477|"~     Capsular contraction is the one of the most common complications of both esthetic and~     reconstructive breast surgery, with high incidence after radiotherapy. The mechanism of the~     contraction is unclear, but is believed to be similar to the formation of hypertrophic~     scarring.~      Dimethyl sulfoxide (DMSO) has demonstrated its use as an anti-inflammatory,~     anti-proliferative, and antibacterial agent.~      The aim of this study is to test the effect of DMSO on the incidence and severity if capsular~     contracture after breast alloplastic reconstruction in irradiated patients.~      We conduct a prospective randomized-control single-surgeon study in the tertiary academic~     Rabin Medical Center.~      110 female candidates for mastectomy, radiotherapy and immediate two-stage reconstruction~     will be included. They will be divided into two groups: the DMSO treatment group, which will~     be treated according to our protocol, and the control group, that will be treated with the~     same protocol but with 0.9% saline instead.~      Several measures will be taken, including: capsular contracture grading by two plastic~     surgeons, a VAS-score of breast pain, maximal capsular thickness (MCT) in sonography~     evaluation, and pathology examination of the capsule (biopsy will be taken during the second~     stage operation).~      Rates and grades of capsular contracture evident clinically, radiologically and~     pathologically, will be evaluated and compared.~   "
103971|NCT02206464|"~     Background:<TAB>~      - Flu virus that causes disease in birds can sometimes spread to people. It can cause severe~     illness, even death. Vaccines are used to try to create resistance to such infections.~     Researchers want to test a new vaccination strategy, combining two different vaccine types,~     the H7 DNA Vaccine (DNA vaccine) and H7N9 Monovalent Inactivated Vaccine (MIV), to see if one~     of two combinations offer better protection against a certain type of bird flu in humans when~     compared to vaccination using two doses of MIV alone.~      Objectives:~        -  To see if 2 vaccines for bird flu, are safe and tolerable for humans.~        -  To study immune responses to these vaccines.~      Eligibility:~      - Healthy adults 18 60 years old.~      Design:~        -  Participants will be screened through a separate protocol.~        -  Participants will be randomly assigned to 1 of 3 groups. Each group will get a different~          combination of vaccines.~        -  Participants will have about 8 clinic visits. Each visit takes 2 4 hours. Blood will be~          drawn at some visits. Urine samples may be collected.~        -  Participants will receive vaccinations at 2 of the visits, 16 weeks apart.~        -  The H7N9 MIV will be injected in the upper arm using a needle and syringe. The DNA~          vaccine will be injected in the upper arm using a device that delivers the vaccine~          through the skin by pressure instead of a needle.~        -  Participants will be observed for at least 30 minutes after each vaccination.~        -  Soon after each vaccination, participants will get 1 2 phone calls, come to clinic for~          evaluation, and complete a diary at home for 1 week. They will record their temperature~          and symptoms and look at the injection site daily.~        -  Participants will have follow-up blood tests.~   "
103972|NCT02206451|"~     Background:~      - Malaria is a disease that affects many people in Mali and in Africa. It is caused by germs~     that are spread by mosquito bites. Researchers are creating vaccines that they hope will~     prevent malaria infection and/or the spread of it.~      Objective:~      - To test if the PfSPZ vaccine can stop malaria spread by mosquitoes.~      Eligibility:~      - People currently enrolled in the ongoing PfSPZ malaria vaccine trial. Participants must be~     willing to have uninfected mosquitoes bite them.~      Design:~        -  Participants will be able to take part in this study at every visit after receiving all~          scheduled vaccinations.~        -  Participants will be asked whether they are willing to participate in the procedures.~          Female participants will have a pregnancy test.~        -  Researchers will put about 60 mosquitoes in 2 or 3 cups (20 or 30 in each cup). They~          will hold each cup to the participant s leg or arm so the mosquitoes can bite. These~          mosquitoes do not carry germs and will take about 3 drops of blood total.~        -  Participants will get a cream for any swelling or itching.~        -  Participants will be checked the next day for any discomfort.~        -  Participants may take part in this feeding test multiple times, if they are willing.~        -  If participants have malaria parasites in their blood, they may be asked to take part in~          another study. For this, they will sleep alone in their hut the night after the feeding~          test. A study team will set up nets to collect mosquitoes that may have bitten the~          participant overnight.~   "
103973|NCT02206438|"~     Supraglottic airway devices (SADs) are well established in anesthetic practice. Among these~     devices ,classic laryngeal airway has been typically widely used. The self-pressurised air-Q~     (air-Q) is newly developed supraglottic airway devices. It is a new single-use device that~     may optimise the airway sealing while reducing the potential for postoperative complications~     such as sore throat. The overall structure of the air-Q SP is identical to the original~     air-Q, except with regard to the inflatable cuff. The aim of this randomized trial was to~     compare the clinical performance of the classic LMA and the air-Q SP.~   "
103974|NCT02206425|"~     The goal of this clinical research study is to evaluate the safety and effectiveness (good~     and bad effects) of ixazomib given as part of a combination therapy to treat subjects with~     relapsed (subjects whose disease came back) or refractory (subjects whose disease did not~     respond to past treatment) multiple myeloma. More specifically, the study is focused on~     subjects who were previously treated with bortezomib (Velcade®) or carfilzomib (Kyprolis®)~     and showed worsening of their myeloma while receiving either one of these drugs in~     combination therapy. This study is a Phase I/II. Ixazomib is an investigational drug, which~     means that ixazomib is currently being tested and is not yet approved by the United States~     Food and Drug Administration (FDA) for subjects with relapsed or refractory multiple myeloma.~     Ixazomib is a new study drug that belongs to the same class as bortezomib and carfilzomib;~     however, unlike bortezomib and carfilzomib, ixazomib is taken by mouth. Current studies~     investigating ixazomib are demonstrating that it is as safe as bortezomib and effective for~     the treatment of multiple myeloma both on its own and in combination with other multiple~     myeloma medications, such as lenalidomide and dexamethasone, or prednisone and melphalan.~   "
103975|NCT02206412|"~     High mobility group 1 (HMGB1) protein is both a nuclear factor and a secreted protein, and~     has recently been identified as a cytokine mediator of systemic inflammation. HMGB1 is~     released by inflammatory cells actively, or increased during cell death passively and~     mediates inflammatory response. It has been reported to have association with the prognosis~     after acute coronary syndrome, ischemia-reperfusion injury of myocardium, atherosclerosis and~     heart failure. This study aimed to investigate the relationship of serum levels of HMGB1 and~     post operative prognosis of patients who had undergone off-pump coronary artery bypass graft.~   "
103977|NCT02206386|"~     To identify effective implementation strategies that can efficiently promote the use of~     evidence-based practices (EBP) across a large number of geographically dispersed, independent~     Home Health Agencies (HHAs). This study will use an agency-randomized design to test the~     effectiveness of a web-based implementation strategy (MHTraining-Net) on the use of an~     evidence-based practice for geriatric depression by home healthcare agencies. The EBP is~     known as the Depression CARE for PATients at Home (CAREPATH) Intervention. The effectiveness~     of MHTraining-Net will be measured by an agency's adherence to the Depression CAREPATH~     protocol with its depressed patients and changes in their patients' depressive symptoms over~     the episode of care.~   "
103978|NCT02206373|"~     Background： The prevalence of chronic kidney disease (CKD) is high in Taiwan. Though there~     are many factors that may affect the measurement of serum creatinine, it is a well-accepted~     marker for renal function assessment. The creatinine clearance (ClCr) estimated by~     Cockcroft-Gault is commonly used as a reference for dosage adjustment; while the estimated~     glomerular filtration rate (eGFR) by Modification of Diet in Renal Disease (MDRD) is used in~     CKD staging. ClCr and eGFR not only have different units, but the results of estimation from~     the two varied among races and individuals. Since 2010, US Food and Drug Administration~     required both the influences of ClCr and eGFR on the pharmacokinetics of a drug in renal~     insufficient patients during pharmacokinetic studies. Because most drugs are excreted through~     kidney, an understanding on the relationship between ClCr and eGFR is important to dose~     safely and effectively. Furthermore, identifying the factors that may influence the~     difference between ClCr and eGFR can provide in-depth consideration during clinical renal~     function assessment.~      Purpose： The purpose of this study is to analyze the correlation between different ClCr and~     eGFR equations in order to provide better renal dose. We also want to find the factors that~     may cause the differences between them.~      Methods： This study will conduct literature review to understand study population during the~     development of different ClCr and eGFR equations, as well as their scope of application.~     National Taiwan University Hospital electronic patient database will be used to analyze the~     correlation between ClCr and eGFR and to identify factors that may influence the difference~     between ClCr and eGFR. The data from patients who have completed 12-hr or 24-hr urine~     collection with calculated renal function will be used to verify the applicability of these~     equations (including a ClCr equation developed by our institute) in Taiwanese.~     Pharmacokinetic principles will be used to analyze the appropriate unit to be used for renal~     function while dosing a patient.~   "
103979|NCT02206360|"~     Early detection testing is recommended for individuals at elevated risk for the development~     of Pancreatic Cancer. This Protocol will define sufficiently elevated risk as either equal to~     or greater than five times the general population risk, or five times the average risk (1.5%)~     of developing pancreatic cancer by age 70; that is a 7.5% lifetime risk. Our inclusion~     criteria has a strong focus on the risk for pancreatic cancer imparted by the presence of~     hereditary cancer genes, as well as by family history. Enrolled subjects will undergo~     Endoscopic Ultrasound (EUS) alternating with Magnetic Resonance Imaging (MRI), every six to~     12 months, for up to 5 years.~   "
103980|NCT02206347|"~     Postural-suprapostural task is defined as postural control takes place while at least one~     other concurrent task is being performed, and appropriate locus of attentional allocation is~     considered a critical factor for successful postural-suprapostural execution. Recent studies~     have indicated that the behavior performance of postural-suprapostural task would be affected~     by the prioritization of attentional allocation (postural-first vs. suprapostural-first);~     however, the inference of the appropriateness of attention prioritization is primarily~     limited to behavior observations and lacks direct neural evidences. How the effect of~     attentional priority between postural and suprapostural tasks on postural-suprapostural~     performance and its underlying cortical mechanism is rarely understood. By adopting~     postural-first and suprapostural-first strategies for postural-suprapostural task, the~     purpose of this 2-year research project is to 1) investigate the differences in performance~     quality and intrinsic neural mechanisms effect of a postural-suprapostural task for healthy~     adults with the analysis of event-related potential (ERP) and non-linear dynamics of behavior~     measures; 2) investigate brain plastic changes and the appropriateness of strategy use. In~     the first year, the attention prioritization effect on reciprocity of a~     postural-suprapostural task will be characterized by integrating the results of behavior~     performance and ERP causal connectivity with a special focus on validation of prevailing~     theoretical models. In the second year, the difference of task fluent for learning a~     postural-suprapostural task with postural-first/suprapostural-first strategy will be studied~     through the spatial and time variations in alpha rhythm after principle component analysis.~     The present project is expected to have significant contributions not only to gain a better~     insight to neural correlates of concurrent postural and motor suprapostural tasks, but to~     optimize treatment strategy for patients with balance or multi-tasking disturbances.~   "
103981|NCT02206334|"~     This phase I trial studies the side effects and the best dose of stereotactic body radiation~     therapy in treating patients with breast cancer, non-small cell lung cancer, or prostate~     cancer that has spread to other parts of the body. Stereotactic body radiation therapy~     delivers fewer, tightly-focused, high doses of radiation therapy to all known sites of cancer~     in the body while minimizing radiation exposure of surrounding normal tissue.~   "
103982|NCT02206321|"~     1. Prospective follow-up and comparative analysis of early, midterm, and long-term surgical~          results and complications between navigation assisted TKA and conventional TKA.~        2. Prospective comparative analysis of cytokines (including ICAM, VCAM, and PECAM) from~          blood, tissues, and drainage between navigation assisted TKA and conventional TKA.~        3. Prospective follow-up of surgical results of navigation-assisted TKA.~   "
103983|NCT02206308|"~     The purpose of this study is to determine whether SCT400 is safe and effective in the~     treatment of B-cell Non Hodgkin's lymphoma~   "
103984|NCT02206295|"~     The primary aim of this study is to demonstrate bioequivalence in the rate and extent of~     absorption between 1600 μg selexipag test drug (administered orally as film-coated tablets of~     1600 μg, twice a day (b.i.d.) and 1600 μg selexipag reference drug (administered orally as 8~     film-coated tablets of 200 μg b.i.d.) at steady-state in healthy male subjects following a~     multiple-dose up-titration scheme.~   "
103985|NCT02206282|"~     A prospective clinical research is to assess the prevalence of implant rupture and presence~     of extracapsular gel in an un-referred population of women who have been implanted with the~     Silimed gel-filled mammary implants with or without any local or systemic systemic symptoms.~   "
103986|NCT02206269|"~     The objective of this Registry is to collect real-world outcome data for bronchial~     thermoplasty (BT) procedures in patients with severe persistent asthma who remain symptomatic~     despite taking standard of care maintenance medications.~   "
103987|NCT02206256|"~     Gastric bypass surgery is the gold standard in bariatric surgery and is a successful method~     to reduce weight in morbidly obese subjects. Patients qualified for gastric bypass surgery~     are routinely pre-treated with a low calorie diet in order to reduce liver volume and to~     facilitate the approach of the gastro-oesophageal junction. Pre-treatment with omega-3 fatty~     acids has similar effects on liver volume, but a prospective comparison of both treatments~     has not been performed yet. Morbidly obese patients respond differently to surgical stress,~     due to a number of factors. First, obesity is associated with a low-grade inflammatory state~     induced by an increased amount of macrophages in adipose tissue. This state is associated~     with higher levels of pro-inflammatory cytokines in serum and with a less adequate immune~     response to infections. Second, obesity is associated with an altered cortisol metabolism~     possibly related to adrenal insufficiency. This could play an important role in the altered~     response to surgical stress and postoperative complications in obese subjects. Third, obesity~     is associated with altered erythrocyte function, including decreased erythrocyte~     deformability and increased aggregation, factors contributing to an impaired~     microcirculation.~      This study has a number of different aims. First, we will compare pre-treatment with the~     standard low calorie diet with omega-3 fatty acids on liver volume in patients qualified for~     gastric bypass surgery because of morbid obesity. Second, we will investigate the effect of~     omega-3 fatty acids on immune function, the low-inflammatory state of adipose tissue, the~     stress response of obese subjects before and erythrocyte function. Third, we will investigate~     the effect of gastric bypass surgery by comparing values before surgery with values on the~     first postoperative day and 6 months after surgery regarding to immunological parameters,~     stress response and erythrocyte function.~   "
103991|NCT02206204|"~     This is a single-center, double-blind, randomized, placebo- and positive-controlled,~     double-dummy, parallel-group, multiple-dose, up-titration study with a nested cross-over~     comparison between moxifloxacin and placebo in healthy male and female subjects. The primary~     objective is to demonstrate that selexipag and its metabolite ACT-333679 do not have an~     effect on cardiac repolarization exceeding the threshold of regulatory concern, at two orally~     administered dose levels (800 and 1600 μg twice daily) in healthy male and female subjects.~     Moxifloxacin is included as a positive control.~   "
103992|NCT02206191|"~     In response to the high prevalence rates of childhood obesity in central Ohio, the Center for~     Healthy Weight and Nutrition (CHWN) established the Primary Care Obesity Network (PCON); a~     partnership between primary care physicians and Nationwide Children's Hospital's Center for~     Healthy Weight and Nutrition, a tertiary care obesity center, the first of its kind in Ohio.~     The overall goal of PCON is to bring an effective and user friendly obesity management~     program to the community physician's office to prevent and treat the growing number of obese~     children in the setting of the private office. The predominant nutrition messaging approach~     to tackling childhood obesity has revolved around the food choices and portion sizes. While~     this is relevant, an area with significant potential for impact for maintaining optimal~     growth and a healthy weight for young children is addressing feeding behaviors and~     self-regulation of intake;. - the how of eating. The investigators objective it to~     investigate whether this self-regulation approach can be employed for an older age group of~     6-11 years old.~   "
103993|NCT02206178|"~     Acetaminophen is one of the most widely used analgesic in the world, recommended for the~     symptomatic treatment of fever and pain.~      The purpose of this study is to assess the effectiveness of acetaminophen in association with~     N-acetylcysteine.~      The objective of this study is to evaluate if the association in healthy volunteers of~     acetaminophen and N-acétylcystéine~        1. - decrease the antinociceptive effect of acetaminophen in comparison to a group control~        2. - and if this antinociceptive effect may depend of the genetic polymorphism of GSH~          enzyme.~   "
103994|NCT02206165|"~     The purpose of this study is to evaluate the efficacy and safety of Candesartan/Amlodipine~     combined or alone and select better dose of CKD-330 in essential hypertension patients.~   "
103995|NCT02206152|"~     This is a single center, double blind randomized cross over design trial that will compare~     the impact of N-acetyl cysteine (200 mg) vs. saline infusion during experimental hypoglycemia~     on day one on the responses to experimental hypoglycemia on day two. 18 participants will be~     studied twice, 8 weeks apart. On each occasion they will undergo a 2 hour hypoglycemic clamp~     (target 50 mg/dl) in the morning and in the afternoon on day one and then again on the~     morning of day 2 and day 3. During the morning clamps, samples will be collected for later~     measurement of serum epinephrine levels, plasma and red blood cell NAC, cysteine, and~     glutathione concentrations and GSH/GSSG ratios (redox status), and participants will be asked~     to complete a hypoglycemia symptom questionnaire~   "
103996|NCT02206139|"~     The term burnout was coined by psychologist Herbert Freudenberger in 1974 in an article~     entitled Staff Burnout in which he discussed job dissatisfaction precipitated by~     work-related stress. A broadly applicable description defines burnout as a state of mental~     and physical exhaustion related to work or care giving activities. A long-standing conceptual~     and operational definition characterized burnout as a triad of emotional exhaustion~     (emotional over extension and exhaustion), depersonalization (negative, callous, and detached~     responses to others), and reduced personal accomplishment (feelings of competence and~     achievement in one's work) In the World Health Organization International Classification of~     Diseases, 10th revision, burnout is defined as a state of vital exhaustion. Although no~     specific diagnosis of burnout is mentioned in the Diagnostic and Statistical Manual of Mental~     Disorders, burnout is a clear syndrome with significant consequences.~      Burnout in health care professionals has gained significant attention over the last several~     years. Given the intense emotional demands of the work environment, clinicians are~     particularly susceptible to developing burnout above and beyond usual workplace stress.~     Residency training, in particular, can cause a significant degree of burnout, leading to~     interference with individuals' ability to establish rapport, sort through diagnostic~     dilemmas, and work though complex treatment decision making. Overall, burnout is associated~     with a variety of negative consequences including depression, risk of medical errors, and~     negative effects on patient safety. The goal of this review is to provide medical educators~     and leaders with an overview of the existing factors that contribute to burnout, the impact~     of burnout, inter specialty variation, and suggestions for interventions to decrease burnout.~   "
103997|NCT02206126|"~     The purpose of this study is to evaluate the effects of moderate energy restriction on the~     body adiposity, severity of OSA, blood pressure, sympathetic activity, oxidative stress,~     inflammatory biomarkers, metabolic profile and endothelial function in obese patients with~     OSA.~   "
103998|NCT02206113|"~     A 16 week pilot study for Allina call center employees to look at the psychological outcomes~     and biological markers after an intervention of using a standing work station. There were two~     groups: group 1 received, and was instructed to use, the standing work station for all 16~     weeks, group 2 was a wait-list control group and received, and was instructed to use, the~     standing work station for the second 8 weeks. Psychological outcomes were measured at weeks~     0, 4, 8, 12, and 16. Biological markers were measured at weeks 0, 8, and 16.~   "
103999|NCT02206100|"~     PER977 administration following a single dose of enoxaparin~   "
104000|NCT02206087|"~     Normal subjects will receive unfractionated heparin followed by a single dose of PER977 with~     dose escalation by cohort. Ten subjects enrolled in Cohort 4 will receive a single dose of~     PER977 followed by a one-week washout and then will receive unfractionated heparin followed~     by a single dose of PER977. The study will provide some insight into the doses that may be~     required to reverse anticoagulation induced by heparin.~   "
104033|NCT02205658|"~     The purpose of this study is to establish normative data for the Adult/Adolescent Sensory~     History (ASH) and to determine if the ASH is able to discriminate between individuals aged~     13-95 years, with Autism Spectrum Disorder (ASD) with or without co-morbid Sensory processing~     Disorder (SPD), individuals with SPD with no co-morbid ASD, and individuals who are typically~     functioning.~      It is anticipated that individuals with ASD will have the most problems with sensory~     processing, those with SPD will also have problems in comparison to typical individuals. It~     is also hypothesized that the measure will be able to discriminate between the three groups.~   "
104034|NCT02205645|"~     Initial evaluation of safety and performance of FibroFix™ Meniscus scaffold~   "
104062|NCT02205281|"~     The purpose of this pilot study is to test the feasibility of an innovative, couples based~     approach to weight management during pregnancy. The primary hypothesis is that a~     couples-based behavioral weight management program will reduce the rate of gestational weight~     gain compared to standard care.~   "
104001|NCT02206074|"~     The investigators are conducting a research study to see if increasing the amount of nitrate~     (a substance found in large quantities in certain vegetables) in the diet can increase the~     ability of individuals with Type 2 diabetes (T2D) to perform exercise. Some people with T2D~     find exercise more uncomfortable than individuals who do not have T2D. This may be explained~     by the experimental studies showing that T2D can result in reductions in the supply of oxygen~     to the muscles. Studies have also shown that for a given level of activity, individuals with~     T2D will be much closer to their maximum exercise capacity than healthy individuals. Dietary~     nitrate may have two important beneficial effects in individuals with T2D: 1) The effects of~     dietary nitrate on the responses to exercise may have a significant impact on the ability of~     individuals with Type 2 diabetes to perform daily tasks and exercise more comfortably and 2)~     experimental studies suggest that increased nitrate consumption has been shown to reduce the~     amount of oxygen required for a given level of exercise.~      The investigators will recruit 60 individuals with T2D. These people will take part in a~     randomised crossover design study where they will be asked to drink normal beetroot juice~     (rich in nitrate) and nitrate depleted beetroot juice, prior to performing two different~     walking exercise tasks (a six minute walk and repeated, low intensity treadmill walking).~     This study aims to determine if dietary nitrate supplementation reduces the amount of oxygen~     required for a given level of exercise in individuals with T2D. To test brain function~     individuals will be asked to perform a standard computerised decision making task following~     consumption of the nitrate rich and nitrate depleted juices.~   "
104002|NCT02206061|"~     The goal of this study is to evaluate the widespread implementation of a developmentally~     appropriate preventive asthma care intervention for urban teens. The School Based Asthma Care~     for Teens (SB-ACT) program includes two core components: 1) a trial of directly observed~     therapy (DOT) to allow the teen to experience the potential benefits from adhering to~     guideline-based asthma treatment, and 2) a developmentally appropriate Motivational~     Interviewing (MI) Counseling Intervention to help the teen transition to independent~     long-term medication adherence. The investigators hypothesize that teens receiving the SB-ACT~     program will 1) experience less asthma-related morbidity than an asthma education (AE)~     attention-control comparison group, and 2) have improved adherence, less urgent healthcare~     use, less absenteeism, improved quality of life, and reduced FeNO compared to AE. The~     investigators also hypothesize that participants receiving DOT-only will have improved~     asthma-related outcomes immediately following their DOT trial vs. teens receiving AE, but~     will not have sustained, clinically significant improvement in outcomes once the DOT phase is~     complete. This represents a unique opportunity to build upon existing community relationships~     with an innovative and developmentally focused program to improve asthma outcomes for urban~     teens.~   "
104003|NCT02206048|"~     The goal of this clinical research study is to learn if it is possible to get high-resolution~     microendoscopy (HRME) images of AIS tissue and/or tissue from microinvasive carcinoma right~     before a biopsy of the cervix. Researchers also want to learn if HRME images can show the~     difference between cancerous tissue and normal cervical tissue.~   "
104004|NCT02206035|"~     This is a phase II open label trial designed to evaluate the efficacy of Tac/MTX/Toc in~     preventing graft versus host disease (GVHD). Outcomes of patients on this clinical trial will~     be compared to those of contemporary controls from the CIBMTR.~   "
104005|NCT02206022|"~     At present, there is no reference protocol for Central Venous Catheter (CVC) insertion~     assuring analgesia, anxiolysis and safety. Medical teams use various levels of analgesia and~     anesthesia to realize this gesture, from single local anesthesia to general anesthesia.~     Remifentanil has been shown to decrease pain scores for insertion and removal of long-term~     central venous access. Remifentanil is also often employed for pediatric or labor analgesia~     for short acts as procedural sedation.~   "
104006|NCT02206009|"~     Is PriMatrix wound dressing capable of regenerating gum tissue inside the mouth?~   "
104007|NCT02205996|"~     Strict glycaemic control has been associated with increased hypoglycaemia and mortality rate,~     the cause of which was unclear, in subjects with type 2 diabetes. In this study, we~     hypothesised that acute hypoglycaemia will result in platelet activation in people with type~     2 diabetes to a higher degree than controls.~   "
104008|NCT02205983|"~     In this study, the investigators will examine the effects of buprenorphine, as compared to~     placebo, upon physiological, subjective, and hormonal responses to a stressful speech task~     and a non-stressful control task in healthy adults. There is strong evidence in support of~     the role of endogenous opioids and opiates in mediating social behavior in humans and other~     animals, and particularly, in social distress. The investigators have recently shown that~     buprenorphine, a partial mu-opioid agonist, reduces cortisol responses to stress. Here, the~     investigators propose to further explore the role of the opioid system in mediating stress~     responses in humans through the use of hydromorphone, a full mu opioid agonist, in addition~     to buprenorphine. The investigators hypothesize that like buprenorphine, hydromorphone will~     reduce both physiological and subjective measures of stress.~   "
104009|NCT02205970|"~     The present study aims to verify the analgesic potential of a new methodological proposal for~     application for transcutaneous electrical nerve stimulation (TENS interactive) using patients~     with primary dysmenorrhoea and compare it with placebo in a randomized double blind study~     with convenience sample.~   "
104010|NCT02205957|"~     Opinion survey to assess the level of satisfaction and the expectations of the residents in~     anesthesiology and intensive care in Tunisia ( North Africa)~   "
104011|NCT02205944|"~     The purpose of this research study is to determine whether two different types of forearm~     exercise, performed before fistula creation surgery, can improve surgery success and fistula~     maturation.~   "
104035|NCT02205632|"~     Lutein ans zeaxanthin, carotenoids provided by dietary intake are mainly located in the~     macular area.~      Its absorption peak at 460 nm may reduce photic damages. The macular pigment density can be~     evaluated by its optical density.~      Reduced macular pigment level is a significant risk factor for age-macular degeneration. The~     nutritional intake can minimise the risk of age-macular degeneration.~   "
104036|NCT02205619|"~     The purpose of this study was to evaluate the residual cementum with the histological~     measurements and root surface topography with SEM evaluation using four periodontal treatment~     methods.~   "
104037|NCT02205606|"~     The purpose of this study is to evaluate efficacy and safety of HCP1306 in patients with~     primary hypercholesterolemia.~   "
104012|NCT02205931|"~     Epilepsy, a condition where individuals are prone to recurrent epileptic seizures, is the~     most common chronic neurological disorder in children. Epilepsy onset is most common in the~     first two years of life and is associated with poor prognosis for seizure control and~     neurodevelopmental outcome.~      The ketogenic diet (KD) is a medically supervised diet that is high in fat and restricted in~     carbohydrates and protein. KD therapy has shown to be an effective treatment for seizures in~     children with epilepsy older than two. Associated benefits include: a reduced requirement for~     routine and emergency antiepileptic drugs (AED) and fewer seizure related hospital~     admissions. Although reports suggest that KD therapy improves seizures in younger children~     there is no high quality trial data that demonstrates effectiveness and safety in this age~     group. The KD is resource intensive, requiring dietetic and physician time; data is required~     to justify expansion of services to cater for the apparent need.~      The investigators therefore propose a prospective multicentre randomised trial to investigate~     the effectiveness and safety of the KD in children with epilepsy under the age of 2, who have~     failed to respond to two or more AEDs. Children will be randomly assigned to either receive~     the KD or further AEDs. The allocated treatment will be started after a 2week baseline~     period, and it's effectiveness assessed after 8 weeks. Seizure diaries will be used to record~     seizures and related events, a questionnaire will be used to assess diet tolerance; also~     growth and blood biochemistry will be monitored.~      The information obtained from this study is necessary to optimise choices in epilepsy~     treatment, aiming to improve outcomes and thus determine whether and when the KD should~     should be used.~   "
104013|NCT02205918|"~     The purpose of this study is to examine how the brain and environment interact to influence~     children's ability to suppress tics using a medical technology called Transcranial Magnetic~     Stimulation (TMS).~   "
104014|NCT02205905|"~     This is an open-label, single-dose, non-randomized study in healthy male subjects to~     characterize the mass balance, metabolic disposition, and identification of the metabolites~     and general metabolic pathways following administration of a single dose of IV solution~     containing 200 mg of PER977 plus a tracer amount of 14C PER977 in health male subjects.~   "
104015|NCT02205892|"~     Double-blind, randomized,4-week small-scale clinical trial for lupeol in the treatment of~     inflammatory and non-inflammatory acne lesions in split face fashion~   "
104016|NCT02205879|"~     The study hypothesis is: Pregabalin is superior to placebo in preventing relapse to drinking~     and reducing drinking severity~   "
104017|NCT02205866|"~     This study evaluates the incidence of Non Receptive endometrium in obese infertile women~     compared to infertile normal weight women using Endometrial Receptivity Array (ERA) test,~     containing 238 genes, identifying the receptivity status of an endometrial sample and~     diagnosing the patient's Window of Implantation, regardless of the histological appearance of~     the sample. An endometrial biopsy is collected from the uterine fundus, either in a natural~     cycle or in a hormonal replacement therapy (HRT) cycle and the test is performed.~   "
104018|NCT02205853|"~     The aim of this study is to develop and identify the most effective strategy to implement~     PCRPs into daily care. We want to assess the added value of a multi-faceted strategy compared~     with a single-faceted patient-directed strategy.~   "
104019|NCT02205840|"~     The purpose of this study is to assess the safety and effectiveness of SI-614 solution~     compared with placebo solution in treating patients with dry eye.~   "
104020|NCT02205827|"~     The purpose of the study is to characterize the distribution and sources of variability in~     whole blood clotting time (WBCT) measurements in human blood collected from healthy~     volunteers by 5 different technicians.~   "
104021|NCT02205814|"~     This study is designed as a double-blind, randomised, placebo-controlled, four parallel arm,~     dose-finding study, to be conducted in approximately 26 sites, to evaluate the efficacy,~     safety, tolerability, and pharmacokinetics of single intra-articular (IA) injections of~     fasitibant in patients with symptomatic osteoarthritis (OA) of the knee.~      Approximately 400 male and female patients 40-80 years old, with BMI < 30 kg/m² and with a~     clinical diagnosis of symptomatic primary osteoarthritis of the knee will be randomised to a~     total of 4 treatment arms. Each arm includes a single intra-articular injection of one of~     three dosages of fasitibant (low, intermediate and high dose) OR placebo. The randomisation~     ratio will be 1:1:1:1.~      The primary efficacy variable will be the change of the Western Ontario and McMaster~     Universities Visual Analogue Scale 3.1 A (WOMAC VA 3.1 A) (total pain) subscore from baseline~     up to 2 weeks after randomisation. Safety will be assessed by monitoring adverse events and~     clinical laboratory tests; local tolerability at the injection site will also be assessed. In~     addition, the population pharmacokinetics and the exposure-response relationship will be~     evaluated.~      The individual experimental clinical phase will last up to maximal 15 weeks encompassing 7~     planned visits at site, including screening, randomisation, 4 follow-up visits and the End of~     study visit.~   "
104022|NCT02205801|"~     We aim to study the effect of local anesthetic when used in conjunction with general~     anesthesia during thyroidectomy or parathyroidectomy. We hypothesize there is equivalent pain~     control between bilateral superficial cervical plexus block and local wound infiltration when~     used in conjunction with a general anesthetic.~   "
104023|NCT02205788|"~     The purpose of this study is to determine if you can use an assay on tumor samples to see~     different patterns in response to the same chemotherapy treatment.~   "
104024|NCT02205775|"~     Myocardial necrosis is relatively frequent after percutaneous coronary intervention and is~     associated with higher mortality during the follow-up.~      Since anti-inflammatory properties of statins have been demonstrated and the benefit of~     statins in acute coronary syndromes have been proven, this study aims at testing the~     hypothesis that the pre-procedural intensive statin treatment reduce the extent of~     peri-procedural necrosis.~   "
104025|NCT02205762|"~     The LCH-IV is an international, multicenter, prospective clinical study for pediatric~     Langerhans Cell Histiocytosis LCH (age < 18 years).~   "
104038|NCT02205593|"~     'Haut-Tief' (Skin Deep) is an educational, stress reducing program for patients with~     psoriasis or atopic dermatitis. A range of support activities will be offered in order to~     learn effective self-management strategies and attitude to one's chronic skin disease and~     consequently improving quality of life.~   "
110108|NCT02126228|"~     The purpose of this study is to discuss whether the parturients who underwent elective~     cesarean of such kind do not need prophylactic use of antibiotics and evaluate the risks and~     economic benefits involved.~   "
104026|NCT02205749|"~     Research with stored biospecimens can provide substantial societal benefits, including~     greater understanding of cancer etiology and discovery of new cancer therapies, but one~     critical social and ethical issue is the use of samples for research unplanned at the time of~     biospecimen collection. Various models for consent (i.e., no consent, notice, opt-out, broad~     consent, study-specific consent) have been proposed for secondary research use of~     biospecimens, but empirical data on individuals' preferences for different consent models are~     limited, particularly from those with limited health literacy and from racial and ethnic~     minority groups. It is critically important to understand the consent preferences of diverse~     individuals, as participation of all population subgroups in biobanks is essential to reach~     translational cancer research goals. Based on a social ecological conceptual framework, the~     investigators will examine preferences for consent models for secondary research uses of~     biospecimens among a racially and socioeconomically diverse sample of women 35 years of age~     and older. The investigators aim to compare experimentally the effect of consent model on~     intentions to donate biospecimens for future research use among a diverse sample of women.~     The investigators hypothesize that women will have stronger intentions to donate based on the~     broad model of consent and the study-specific model of consent compared with the notice model~     of consent. These findings from groups underrepresented in research will be critical since~     the participation of these groups in biobanks is essential to generating findings that will~     achieve translational research goals of eliminating cancer disparities.~   "
104027|NCT02205736|"~     Subjects will be recruited from the participants in the Union and Mecklenburg County Living~     Room Visits. Participants in the Living Room Visit will have been recruited using community~     event flyers. During the Living Room Visits, the Health Educator will provide a general~     overview of the study. Individuals who are interested in participating in the study will then~     be generally screened for eligibility by the Protocol Coordinator who will then proceed to~     provide informed consent to potential subjects.~   "
104028|NCT02205723|"~     The objective of this protocol is to pilot an innovative approach to medication adherence to~     determine if such an approach will improve inhaled corticosteroid (ICS) medication adherence,~     a critical gap in improving the health of children with asthma. SNAPP incorporates~     monitoring, reminders, and dynamic feedback through a smartphone that will improve ICS~     medication adherence and that the investigators believe will influence the child's future~     independence and chronic disease-management skills.~   "
104029|NCT02205710|"~     Cognitive training has emerged as a promising method to maintain, enhance, and rehabilitate~     cognitive function in older adults and individuals with dementia. In recent years, such~     training has become particularly appealing in the clinical context, with many paradigms aimed~     specifically at adults experiencing various stages of cognitive decline due to Mild Cognitive~     Impairment, Alzheimer's disease, and vascular dementias. However, basic questions remain. For~     example, uncertainty persists regarding factors that influence observed improvements as well~     as the conditions that would maximize transfer and sustainability of training effects. The~     objective of this study is to evaluate factors that may maximize the benefits of computerized~     cognitive training in older adults.~   "
104030|NCT02205697|"~     Diet quality has been associated with a variety of chronic diseases including obesity. One~     measure that has been studied as an indicator for diet quality is fruit and vegetable intake.~     Although the US government has suggested that American's increase their intake of fruit and~     vegetables, epidemiological data suggest that most Americans have not been successful doing~     do, with the strongest disparity seen in people of low socioeconomic status (SES). This~     disparity in fruit and vegetable intake is thought to be the result of both individual and~     environmental factors that influence this health behavior. To help decrease the disparate~     rise in incidence of chronic disease in people of low SES, effective, cost-efficient and easy~     to implement interventions to improve fruit and vegetable intake and diet quality are needed.~      Theoretical models of health behavior change have been successfully used in research~     targeting individual factors associated with health behaviors. One theory, the Theory of~     Planned Behavior (TPB), and a proposed extension of this model (implementation intentions)~     have been shown to be effective to increase fruit and vegetable intake in (mostly) white~     adults of average socioeconomic status. It is not know whether an implementation intention~     intervention to increase fruit and vegetable intake would be effective in women who are of~     low socioeconomic status. The primary aim of this research is to study (using quantitative~     and qualitative analysis) an implementation intention intervention to produce a positive~     change in fruit and vegetable intake. We theorize that the setting of an implementation~     intention in this group will be effective, cost-effective, and easy to implement intervention~     to promote an increase in fruit and vegetable intake.~   "
104031|NCT02205684|"~     Physical health problems are common in schizophrenia with a two- to three-fold increased~     morbidity and mortality rate, resulting in a 20 years reduction in life expectancy. A genetic~     vulnerability for developing cardiovascular disease has been documented in these patients,~     and many lifestyle factors also negatively influence physical health. Patients with~     schizophrenia are likely to smoke, are physically inactive and overweight, suffer from~     malnutrition due to unhealthy diet, and have reduced cardiorespiratory fitness. Moreover,~     these patients have increased risk of developing diabetes mellitus type II and metabolic~     syndrome. These aspects demonstrate the need for multi-disciplinary treatments of patients~     with schizophrenia and underline the need for addressing their physical health.~      Poor physical fitness seems to be associated with exacerbated negative symptoms and increased~     cognitive dysfunction in patients with schizophrenia. However, evidence on physical activity~     and its consequences in schizophrenia is scarce. In this randomized controlled trial we~     investigate the effects of high intensity training in outpatients with schizophrenia on~     psychotic symptoms and well-being, cognition and cortical structure, tobacco smoking and~     substance use, in addition to metabolic indices.~   "
104032|NCT02205671|"~     The program consists of a 6-week small-group workshop for caregivers of people with memory~     problems.~      The goal of the study is to evaluate in a one year longitudinal study, program effectiveness~     in reducing caregiver stress, depression, fatigue, burden, days lost from work and improving~     sleep, healthful behaviors and self-efficacy~   "
104138|NCT02204293|"~     Interleukin-1 antagonists such as canakinumab have been used for the treatment of AOSD and~     have had a marked influence on the activity of the disease, including joint mobility. Results~     from controlled clinical studies are not, however, currently available.~   "
104039|NCT02205580|"~     Postoperative pain following tonsillectomy or adeno-tonsillectomy in children is severe and~     sometimes last for days. Sufentanil is used by epidural route for postoperative analgesia in~     children. There are few reports about its use for postoperative analgesia by continuous~     intravenous infusion. Its complications include , hypoxia, sedation, pruritus ,nausea and/or~     vomiting.~      The investigators design this protocol to test efficacy of analgesia of three different rates~     of continuous intravenous sufentanil infusion for postoperative pain management following~     coblation tonsillectomy or adeno-tonsillectomy in children. The investigators also compare~     incidence rate of complications for three groups.~   "
104040|NCT02205567|"~     Bergamot-derived products have shown significant effects on plasma lipids. We aim in the~     present study to evaluate the effect of bergamot on several cardio-metabolic risk markers.~   "
104041|NCT02205554|"~     The purpose of this study is to compare the safety, pharmacokinetic properties (the~     absorption, distribution and excretion), and analgesic activity of Omnitram (10 mg tablets),~     Tramadol (Ultram, 50 mg tablet) following oral administration of 9 doses healthy subjects.~   "
104042|NCT02205541|"~     The investigators aim to perform the first controlled randomized prospective study using ECZ~     in pediatric STEC-HUS. This is of great interest as there is still no efficient specific~     therapy in that potentially devastating disease.~      Furthermore, published data concerning the use of ECZ in STEC-HUS are controversial,~     reflecting statistical bias in retrospective or uncontrolled studies, thus emphasizing the~     need for prospective studies.~   "
104043|NCT02205528|"~     This trial is conducted in the United States of America (USA). The aim of the trial is to~     investigate the efficacy, safety, and tolerability of once-daily subcutaneous (SC) injections~     of NNC0090-2746 for 12 weeks, as an adjunct to metformin, in participants with T2D.~   "
104044|NCT02205515|"~     Approximately 50% of patients with neuroendocrine cancers present with metastasis, a vast~     majority to the liver. In such patients, one treatment option for liver-directed therapy is~     surgical resection. However, a significant proportion of patients are not eligible for~     resection because of patient factors (age, comorbidities) or tumor-related factors.~      There have been scant data on the utility of EBRT (external-beam radiotherapy) and SABR~     (stereotactic ablative radiotherapy) for metastatic neuroendocrine tumors of the liver. This~     study will measure the effects of concurrent everolimus with external-beam radiotherapy to~     the liver for metastatic neuroendocrine New methods of tumor assessment are needed in NETs.~     Three new techniques are being developed at the Sunnybrook Research Institute to assess~     tumour response to treatment: (1) contrast enhanced ultrasound; (2) perfusion CT; and (3)~     perfusion MRI. These methods are devised to measure tumour perfusion and blood flow as~     response indicators and can measure cell death non-invasively.~        1. Concurrent everolimus given with external-beam radiotherapy to the liver for metastatic~          neuroendocrine tumors of the liver will enhance the efficacy of radiotherapy and add~          little, if any, toxicity~        2. New radiological measures of CEUS and DCE-CT are effective measure to delineate tumor~          response in NETs.~   "
104045|NCT02205502|"~     Ketamine seems an obvious choice in the setting of an emergency department in laceration~     repair.~      Lidocaine is the local anesthetics widespread used.~      Ketamine leads to dissociative amnesia.~      Theoretically , lidocaine is not useful in laceration repair using ketamine.~      However, lidocaine is used with ketamine in many emergency department.~      The investigators compare lidocaine with placebo as an adjunct to ketamine sedation in~     children undergoing primary closure~   "
104046|NCT02205489|"~     Primary Objective:~      To assess the distribution of IARs by severity grade when LEMTRADA is administered to RRMS~     patients who will be medicated according to specified algorithm designed to manage infusion~     associated reactions.~   "
104047|NCT02205476|"~     Study is a multicenter, two-part, open-label phase II study in adults, evaluating the safety~     and long-term efficacy of PF-06473871 one year after surgical revision and treatment with~     PF-06473871.~   "
104048|NCT02205463|"~     This dose-escalation study is to determine the safety, maximum tolerated dose (MTD) and~     efficacy of KD019 in combination with trastuzumab and mFOLFOX-6.~   "
104049|NCT02205450|"~     The PWS is a genetic disease with intellectual disabilities associated with multiple~     manifestations in other body systems. It is characterized by hypothalamic-pituitary~     abnormalities with severe hypotonia during the early years of life, conditioning feeding~     difficulties. Hyperphagia appears later, causing severe obesity in pre - school ages. Other~     endocrine abnormalities associated produce short stature, GH deficiency and hypogonadotropic~     hypogonadism. These patients also have varying cognitive dysfunction associated as well as~     learning problems, compounded by the development of psychological-psychiatric and behavioral~     problems language. The aetiology of GH decreased secretion of the SPW is controversial, it is~     known that IGF -1 levels are reduced in children and adults with PWS. The rational use of GH~     is derived from knowledge of comorbidities observed in PWS, which seem to be related to GH~     deficiency: hypotonia, altered body composition, decreased growth, even obesity.~      • The GH is accepted since 2000 for the treatment of PWS. Following fatal episodes in our~     country, it was decided to start treatment at 2 years of age in an arbitrary manner, but not~     in the U.S. or France. Subsequent studies have found that GH per se is not a risk factor for~     mortality. The currently published data supporting the benefits of GH treatment when started~     between 4 and 6 months of life, even some experts advocate starting at 3 months, but due to~     the lack of consensus on the age of onset treatment, despite the benefits of your home at an~     early age before the onset of obesity often starts around 2 years of life.~      HYPOTHESIS The use of GH is safe and effective in patients with PWS children under 2 years~     old.~   "
104060|NCT02205307|"~     This is a randomized, controlled, parallel, multicenter study to determine the difference in~     post-operative anastomotic leak rate in low anterior resection procedures where colon and~     rectal tissue perfusion is evaluated using PINPOINT as an adjunct to standard surgical~     practice compared to surgical procedures performed according to standard surgical practice~     alone.~   "
104061|NCT02205294|"~     Osteopathic treatment will provide:~        1. A significant reduction of pain and swelling of the affected DVT leg~        2. An increase in the quality of life (QOL) for individuals with DVT of the leg~        3. Improved signs and symptoms of the post thrombotic syndrome of the affected DVT leg~   "
110117|NCT02126111|"~     The purpose of this study is evaluate the efficacy of a depigmented grass extract in the~     treatment of local allergic rhinitis.~   "
104050|NCT02205437|"~     Schizophrenia is a severe and chronic mental disorder. The lifetime risk of schizophrenia is~     around 1%. Its course is chronic and frequently disabling. The keystone of schizophrenia~     treatment is antipsychotic medications. The use of antipsychotics represents a huge public~     health and economic burden to society. Most of antipsychotics drugs are metoo drugs,~     directly or indirectly replicating dopamine D2 receptor blockade. Pharmaceutical companies~     have aimed to produce drugs with a general indication for all patients with schizophrenia~     with a one-size-fits-all strategy with no targeting or stratification. Second generation~     antipsychotics partly improve positive symptoms and are quite often associated to weight~     gain, metabolic changes and increased risk of cardiovascular diseases. Antipsychotics only~     achieve a certain degree of clinical improvement in a percentage of patients (45%) and 30% of~     the patients are treatment resistant. In light of the current deadlock, there is an urgent~     need to expand the horizon of pharmacological research by elucidating new mechanisms related~     to antipsychotic actions. An alternative strategy is the comparison of gene expression~     profiles in drug-naive accurately ill patients before and after antipsychotic treatment has~     been initiated. Our research group has a great experience in the field and has been working~     on this hypothesis in the latest years. We propose a continuation project to thoroughly~     explore the clinical implications (clinical response to antipsychotic drugs or emergence of~     metabolic side effects) of the variants in gene expression we have recently described in~     schizophrenia patients. This project takes advantage of an exceptional (regarding to the~     detailed knowledge of clinical outcome and side effect profile) longitudinal cohort of~     drug-naive patients with schizophrenia who had been followed up for three years at the~     University Hospital Marqués de Valdecilla.~   "
104051|NCT02205424|"~     Stroke and dementia are two of the most common and disabling conditions worldwide,~     responsible for an enormous and growing burden of disease. There is increasing awareness that~     the two conditions are linked, with cognitive impairment and dementia common after stroke,~     vascular dementia accounting for about one-fifth of all dementia cases and recent evidence on~     the contribution of vascular risk factors to Alzheimer's disease. Yet we still know very~     little about whether brain volume loss - a hallmark of dementia - occurs after stroke, and~     whether such atrophy is related to cognitive decline. The aim of this research is to~     establish whether stroke patients have reductions in brain volume in the first three years~     post-stroke compared to control subjects, and whether regional and global brain volume change~     is associated with post-stroke dementia in order to elucidate potential causal mechanisms~     (including genetic markers, amyloid deposition and vascular risk factors). We hypothesise~     that stroke patients will exhibit greater brain volume loss than comparable cohorts of~     stroke-free controls, and further, that stroke patients who develop dementia will exhibit~     greater global and regional brain volume loss than those who do not dement. An understanding~     of whether stroke is neurodegenerative, and in which patients, may be used to help guide the~     early delivery of disease-modifying therapies.~   "
104052|NCT02205411|"~     The purpose of the study is to evaluate the safety and effectiveness of the ReliantHeart~     HeartAssist 5® VAD System in patients listed for heart transplantation and at risk of death~     from refractory end-stage heart failure.~   "
104053|NCT02205398|"~     This was an open-label, phase Ib, multicenter clinical trial to determine the MTD/RDE of the~     orally administered c-MET inhibitor INC280 in combination with cetuximab. This combination~     was to be explored in c-MET positive mCRC and HNSCC patients whose disease progressed on~     cetuximab or panitumumab treatment. The dose escalation part was to be guided by a Bayesian~     Logistic Regression Model with overdose control. At MTD/RDE, additional mCRC and HNSCC~     patients who progressed on cetuximab or panitumumab treatment were to be enrolled in two~     expansion groups to further assess the anti-tumor activity and the safety and tolerability of~     the combination of INC280 and cetuximab. Patients were to receive INC280 on a continuous bid~     dosing regimen and cetuximab every week. A treatment cycle was defined as 28 days with no~     scheduled break between cycles.~      The trial was terminated because of difficulties in identifying patients who met the~     eligibility criteria.~   "
104054|NCT02205385|"~     Subjects are being asked to participate in this study because they have an arm or leg~     amputation and have developed pain related to a neuroma (an ongoing localized pain related to~     a cut nerve ending).~      We are studying two different types of surgery to treat the neuroma pain. Today there are~     many surgical options reported which often means that there is no one best treatment. The~     surgery that shows the best success so far, involves cutting out the scarred nerve ending~     (neuroma) and burying the freshly cut nerve ending in a nearby muscle. Recently, a new~     surgery has been developed called targeted reinnervation (TR). This surgery connects these~     cut nerve endings to nerves going into nearby nonfunctional muscles. This surgery was~     developed to allow amputees to have better prosthesis control. By chance, neuroma pain~     improved significantly with TR. We, therefore, are conducting this clinical trial to evaluate~     which of these two surgeries best treats neuroma pain. We will ask all participants to fill~     out a questionnaire both before and after surgery. This will help us understand how a neuroma~     affects the quality of life of amputees and will allow us to understand which surgery leads~     to the best improvement in neuroma pain.~      In order to confirm the presence and location of the neuroma before surgery, a magnetic~     resonance image (MRI) will be performed. Taking these pictures requires subjects to lie still~     for a short period of time but does not involve any invasive procedures. After surgery, the~     MRI will be done again, this time to see if the nerve shows signs of scarring.~   "
104055|NCT02205372|"~     The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of MT-3995~     in Subjects with Diabetic Nephropathy.~   "
104056|NCT02205359|"~     The purpose of this clinical study is to test the hypothesis that market released Cardiac~     Resynchronization Therapy (CRT) devices which contain the AdaptivCRT® (aCRT) algorithm have a~     superior outcome compared to standard CRT devices in CRT indicated patients with normal~     atrio-ventricular (AV) conduction and left bundle branch block (LBBB).~   "
104057|NCT02205346|"~     Investigate urinary leukotriene E4 levels and determine if there is a correlation with~     severity of obstructive sleep apnea. The investigators then would like to determine a~     threshold level which could then be used for confirmation of diagnosis of obstructive sleep~     apnea (OSA).~   "
104058|NCT02205333|"~     The main purpose of this study is to determine the best dose of MEDI6469 that is safe and~     tolerable when given as monotherapy and in combination with tremelimumab, MEDI4736~     (durvalumab), or rituximab in participants with either advanced solid tumors or diffuse large~     B-cell lymphoma (DLBCL). Tremelimumab and MEDI4736 (durvalumab) will be tested with MEDI6469~     in a set of participants with advanced solid tumors while rituximab will be tested with~     MEDI6469 in participants with DLBCL. MEDI6469 will be tested as monotherapy in participants~     with advanced solid tumors.~   "
104059|NCT02205320|"~     This is a comparative pharmacokinetic, pharmacodynamic and safety study in healthy volunteers~     with three forms of pegylated granulocyte colony stimulating factors.~   "
104063|NCT02205268|"~     Background Attention Deficit Hyperactivity Disorder (ADHD) is one of the most frequently~     diagnosed behavioural disorders in childhood that requires treatment(3-5% of children). It is~     an important health problem because it impairs social, educational and occupational~     performance, and increases the risk of other psychiatric disorders including anxiety,~     depression and substance misuse. There is no cure for ADHD and standard stimulant medication~     treatment is at best symptomatic. Moreover, stimulants have side effects and parents are~     often concerned over the long-term effects. A number of non-drug treatments have been~     developed but these do not target the brain directly. Neurofeedback Training (NTx) is a new,~     non-drug treatment that targets the brain directly and that can potentially enhance the~     control of attention in ADHD. NTx could be a valuable alternative and/or adjunct to standard~     care.~      Aims Although NTx has gained popularity in Europe and the US, more rigorous studies are~     required to support its implementation in the NHS. We therefore propose a pilot study to~     establish tolerabilty and safety, and to develop treatment protocols and collect data to~     design a follow-on controlled NTx trial in ADHD.~      Methods We plan an open label, single arm, treatment trial of near infrared spectroscopy~     neurofeedback training of frontal lobe activation in school-aged children with ADHD. 48~     participants will be recruited over 1 year and will be offered 20 NTx sessions over 10 weeks.~     Participants will be recruited from Mental Health Services. Primary outcomes will be safety~     and tolerability and secondary outcomes will include standard clinical behavioural rating~     scales and the Test Of the Variables of Attention.~   "
104064|NCT02205255|"~     A second sub-analysis of the BACE trial will include a detailed cost-effectiveness study.~   "
104065|NCT02205242|"~     A first sub-analysis of the BACE trial will address physical activity levels in a subgroup of~     the intervention study with portable validated activity monitors.~   "
104066|NCT02205229|"~     Single center, prospective, observational study to assess serum concentration of ingredients~     used in multi-ingredient, topical compounded medications from Medimix Specialty Pharmacy.~   "
104067|NCT02205216|"~     Freezing of gait in Parkinson's disease (PD) is a major cause of disability and falls and~     responds often incompletely to conventional therapy. The pathogenesis remains largely unknown~     and therapeutic alternatives are needed. Rehabilitative interventions that consist of~     learning cognitive strategies with sensory cueing to prevent and to overcome FOG represent~     the most efficacious intervention, but difficulties in learning and execution of these~     cognitive strategies are the main cause of failure. Transcranial direct current stimulation~     (tDCS) enhances motor task learning and execution in patients with PD and might enhance the~     efficacy of rehabilitative interventions.~      This study intends to address the following question whether tDCS can enhance the efficacy of~     rehabilitative interventions in the treatment of freezing of gait in Parkinson's disease?~   "
104068|NCT02205203|"~     This research study aims to test the feasibility and effectiveness of using the Mayo Clinic~     Anxiety Coach smartphone app as an addition to traditional therapy for the treatment of~     anxiety disorders in youth, particularly those youth who may have limited access to mental~     health treatment in the traditional clinical setting.~   "
104069|NCT02205190|"~     A phase I clinical trial to compare the pharmacokinetics and safety of~     fimasartan/rosuvastatin combination tablet and coadministration of fimasartan and~     rosuvastatin in healthy male volunteers~   "
104070|NCT02205177|"~     This research study aims to test the feasibility and effectiveness of using the Mayo Clinic~     Anxiety Coach smartphone app as an addition to traditional therapy for the treatment of~     anxiety disorders in youth, particularly those youth who may have limited access to mental~     health treatment in the traditional clinical setting.~   "
104071|NCT02205164|"~     The aim of present study is to evaluate if the addition of Aprepitant to multiple doses of~     palonosetron IV enhances the efficacy of multiple doses of palonosetron IV alone, in~     preventing CINV in AML or High risk MDS patient, treated with multiple days chemotherapy.~   "
104072|NCT02205151|"~     An Open-label, Randomized, Single-dose, 2×2 Crossover Study to Compare the Pharmacokinetics~     of Fimasartan/Amlodipine Combination Tablet and Coadministration of Fimasartan and Amlodipine~     as Individual Tablets in Healthy Male Volunteers~   "
104073|NCT02205138|"~     Among existing surgical techniques, spinal fusion is considered as the gold standard to treat~     a broad spectrum of degenerative spine disorders, including spondylolisthesis and scoliosis,~     with regard to pain reduction and functional improvement. However, pseudarthrosis and failure~     to relieve low back pain are unfortunately still frequent, irrespective of the type of~     procedures and grafts used by the surgeon.~      The present Phase 2a study aims at demonstrating the safety and efficacy of ALLOB®, a~     proprietary population of allogeneic osteoblastic cells, in lumbar spinal fusion.~   "
104074|NCT02205125|"~     Removal of polyps at colonoscopy reduces colon cancer. Snare polypectomy is the conventional~     method for removal however the snared area after removal can occasionally appear uneven~     raising the possibility that complete removal has not occurred. The significance of this~     irregularity has not be studied. This study aims to separately sample the irregular area and~     determine the constituents while recording how frequently this occurs during routine~     colonoscopy and polypectomy. We hypothesize that the irregular areas are submucosal tissue~     and do not represent polyp tissue left behind.~   "
104075|NCT02205112|"~     The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of~     intravenous nemonoxacin compared with intravenous moxifloxacin in adult patients with~     community-acquired pneumonia (CAP).~   "
104076|NCT02205099|"~     This is a single-site, randomized, double-blind, placebo-controlled, multiple dose, flexible~     dosage range, PK and PD study of SKL15508 as monotherapy in subjects with stable~     schizophrenia.~   "
104077|NCT02205086|"~     This study compares the ability of clinicians to make diagnoses with or without the~     assistance of diagnostic decision support software. The area of clinical focus is primarily~     rheumatology.~   "
104200|NCT02203487|"~     The objective of the present study was to obtain information about the safety and~     tolerability of BIIF 1149 BS after repeated dosing and to obtain preliminary pharmacokinetics~     data (steady state and accumulation factor)~   "
104201|NCT02203474|"~     The primary objective of this study is to demonstrate the superiority of tiotropium~     hydrofluoroalkane (HFA) breath actuated inhaler (BAI) to placebo HFA BAI following repeated,~     once-daily dosing.~   "
104078|NCT02205073|"~     This is a single site, randomized, double-blind, three period cross-over, placebo-controlled,~     proof of mechanism study in healthy male subjects. The study will investigate whether the~     directionality of brain activity and connectivity in response to intranasal vasopressin~     treatment is similar to earlier studies and explores the effect of short-term treatment with~     RG7314 on functional MRI as a pharmacodynamic marker. While in the scanner, the participants~     will be asked to perform a face matching task and a Theory of Mind task, among other~     assessments. Participants' exposure to study drug will be assessed and all participants will~     receive follow-up examination 1 and 4 weeks after last dose.~   "
104079|NCT02205060|"~     The therapeutic efficacy of virtual reality has been validated for the treatment of various~     mental disorders ,smoking behavior is the first preventable cause of death in developed~     countries However, after a successful withdrawal, a high relapse rate (between 40 and 70%)has~     been observed, which emphasize the urgent need to implement new strategies. Virtual reality~     cue exposure for the relapse of tobacco consumption~   "
104080|NCT02205047|"~     The purpose of this study is to find out whether either trastuzumab or the combination of~     trastuzumab and pertuzumab with standard chemotherapy shows more activity against~     gastro-oesophageal adenocarcinoma than standard chemotherapy given before and after surgery~     and it can be safely administered.~   "
104081|NCT02205034|"~     The Prader-Willi syndrome (PWS) includes severe neonatal hypotonia with impaired suckling~     leading to failure to thrive in the most severe cases, subsequently followed by an early~     onset of morbid obesity with hyperphagia and deficit of satiety, combined with other~     endocrine dysfunction probably due to hypothalamic dysfunction. The pathophysiological~     mechanism of the occurrence of the 2 main nutritional phases of PWS is unknown. Swaab~     reported a deficit in the oxytocin (OT)-producing neurons of the paraventricular nucleus in~     the brain of these patients. In addition of its well-known anorexigenic effect, OT is~     involved in establishing and maintaining social codes. Moreover in a PWS mouse model~     generated from a MAGEL2 KO gene a single OT injection at 5 hr of life prevent the early death~     observed in 50 % of the new born mice by recovering normal suckling. Interestingly this~     effect is no longer observed if OT injection takes place later. Our hypothesis is that early~     administration of OT in babies with PWS may improve suckling and possibly infant-mother~     interactions. In our recent study (manuscript in preparation), we have shown that a single~     intranasal administration of OT is well tolerated. This escalating dose study is designed to~     evaluate the tolerance of repeated intranasal administration of OT in 3 steps (4IU every~     other day, 4 IU daily, 4IU twice daily) in babies younger than 5 months with PWS.~   "
104082|NCT02205021|"~     Accumulation of fat in the neck using tape measures has been linked to increased~     cardiovascular risk. The investigators' hypothesis is that detailed measures of neck fat~     using computed tomography will show that specific fat compartments in the neck contribute~     differently to cardiovascular risk.~   "
104083|NCT02205008|"~     Intraperitoneal chemotherapy as an adjuvant treatment modality is designed to eradicate~     intraperitoneal free tumor cells that can be a source of peritoneal carcinomatosis. Although~     we have not reached unanimous consensus, favorable reports on the outcome of intraperitoneal~     chemotherapy have been published.~      In this study, we review the clinicopathological characteristics of patients and effects of~     early postoperative intraperitoneal chemotherapy (EPIC) on overall and gastric~     cancer-specific survival and patterns of recurrence of gastric cancer patients with~     macroscopic serosal invasion.~      The aim of this study is to evaluate the impact of intraperitoneal chemotherapy on overall~     and disease free survival of advanced gastric cancer patients with serosal invasion after~     potentially curative surgery.~   "
104084|NCT02204995|"~     Trapeziometacarpal osteoarthritis is a common cause of pain and loss of hand function in~     postmenopausal women. Many surgical treatments have been described and recent literature has~     show that the relatively simple trapeziectomy gives equal results and less complications,~     when compared to other techniques such as ligament reconstructions and interpositions. These~     studies have been conducted predominantly in patients with stage 2 or 3 osteoarthritis. Stage~     4 osteoarthritis is characterized by more cartilage and soft-tissue damage, which increases~     the chance for collapse of the first metacarpal bone and associated problems.~      The investigators' hypothesis is that an LRTI can be of additional value in patients with~     stage 4 osteoarthritis.~   "
104085|NCT02204982|"~     A study to evaluate the safety and efficacy of IPI 145 administered in combination with~     rituximab vs placebo in combination with rituximab in patients with previously treated~     CD20-positive follicular lymphoma who are not suitable candidates for chemotherapy.~   "
104086|NCT02204969|"~     The thermal therapy combined with magnetic fields and ozone has a direct effect on patients~     with dementia and Alzheimer's with a regression of more than 60% of them~   "
104087|NCT02204956|"~     Smoking rates among individuals with psychiatric disorders are disproportionately higher than~     the general population. The majority of psychiatric hospitals ban smoking on hospital~     grounds, thus providing an opportunity for inpatients to experience abstinence. Yet smokers~     in inpatient psychiatric settings are infrequently provided with referrals for cessation~     treatment on discharge (< 1 %) and most resume smoking upon discharge. Therefore, the~     integration of effective cessation interventions within the current mental health treatment~     system is a public health priority.~      The overall objective of this project is to adapt a Sustained Care (SusC) model to smokers~     with severe mental illness (SMI) engaged in a psychiatric hospitalization and to conduct a~     randomized, pragmatic effectiveness trial designed to assess the benefit of this adapted SusC~     intervention in real-world practice. We will test the hypothesis that, among smokers with SMI~     in inpatient psychiatric treatment (n = 422), SusC will result in significantly greater rates~     of cotinine-validated, 7-day point prevalence abstinence at 6- and 12-months compared to a~     group that receives Usual Care (UC) about smoking cessation. Furthermore, we hypothesize that~     a higher proportion of SusC vs. UC patients will use evidence-based smoking cessation~     treatment (counseling and pharmacotherapy) in the month after discharge. We will also explore~     the effect of SusC on health and health care utilization in the 12 months post-discharge~     (psychiatric symptoms, psychiatric and medical hospital readmissions and emergency room~     visits) and the effectiveness of SusC on smoking abstinence in patient diagnostic subgroups.~      The expected outcome of this project is a demonstration of the effectiveness of a Sustained~     Care intervention for smoking cessation in individuals with severe mental illness (SMI)~     following psychiatric hospitalization. Future studies could extend these findings to~     individuals with SMI receiving outpatient psychiatric treatment or psychotherapy. Overall,~     this research would have a significant positive public health impact that will move us closer~     to the long-term goal of dissemination and integration of the Sustained Care model to~     increase smoking cessation and decrease smoking related morbidity and mortality in people~     with severe mental illness.~   "
104202|NCT02203461|"~     Changes in insulin resistance in healthy volunteers with normal body weight (BMI 18-25) after~     14 days of STRIBILD®-, Truvada®/Kaletra® or Truvada®/Prezista®/Norvir® intake, measured by~     hyperinsulinemic euglycemic clamp.~   "
106352|NCT02175316|"~     This study will evaluate the effects of Enhanced External Counterpulsation on delayed onset~     muscle soreness. The primary outcomes will be duration of delayed onset muscle soreness, WBC~     count, CRP count, CPK count, and pain tolerance.~   "
104088|NCT02204943|"~     This study will examine biomarkers involved in osteomimicry in bone metastases and~     circulating tumor cells (CTCs) of men with mCRPC before and during therapy with the~     bone-targeting radiopharmaceutical radium-223. This study will also examine the~     bio-distribution of radium-223 in bone and bone metastases of men with mCRPC.~      The investigators hypothesize that bone metastases and CTCs in men with mCRPC will commonly~     express markers of EMT/plasticity and osteomimicry, not just in the normal surrounding~     osteoblastic stroma but in the epithelial tumor cells themselves and that radium-223 will~     target both of these compartments including the more mesenchymal/osteoblastic tumor cells and~     the surrounding osteoblasts in the active bone microenvironment, with a relative sparing of~     normal bone and bone marrow.~   "
104089|NCT02204930|"~     The purpose of this First in Man study is to evaluate the safety and tolerability, as well as~     to explore efficacy of PeproStat, a new peptide based coagulant (haemostat), when used in~     patients undergoing open liver resection surgery.~   "
104090|NCT02204917|"~     In this clinical trial the investigators aim to evaluate the diagnostic feasibility and~     safety of ceVUS with the intravesical use of OPTISON for vesicoureteral reflux detection and~     urethral imaging in children.~   "
104091|NCT02204904|"~     Study ALD-103 is a multi-site, global, data collection study designed to evaluate safety and~     efficacy of allogenic hematopoietic stem cell transplantation (allo-HSCT) in patients with~     CALD aged 17 or younger.~   "
104092|NCT02204891|"~     The aim of the present study is to demonstrate the effect of a mixture of four species of~     probiotics (Saccharomyces boulardii, Bifidobacterium lactis BB-12, Lactobacillus acidophilus~     LA-5 and Lactobacillus plantarum) in patients with symptomatic irritable bowel syndrome (IBS)~     who have culture verified syndrome of intestinal bacterial overgrowth (SIBO) and those who do~     not have. This will provide direct evidence for the role of probiotics in treating part of~     the pathogenesis of IBS.~   "
104093|NCT02204878|"~     To searching the role of parecoxib sodium for postoperative pain management in open~     hepatectomy~   "
104094|NCT02204865|"~     Sleep disordered breathing, in which patients my breath deeply, shallowly or stop breathing~     for periods whilst asleep, is common in heart failure and associated with a poor prognosis.~     This study aims to validate a novel function available on certain pacemakers which is~     designed to detect this condition.The investigators hypothesize that ApneaScan can accurately~     detect moderate to severe sleep disordered breathing in patients with heart failure as~     compared against an Embletta sleep study. The investigators will also follow up our patients~     for 2 years to determine whether the severity of sleep disordered breathing as assessed by~     ApneaScan correlates with prognosis.~   "
104095|NCT02204852|"~     Objective Evaluating the safety and efficacy of iloprost and eptifibatide co-administration~     compared to placebo as an addition to standard care in septic shock patients.~      Trial rationale Iloprost and eptifibatide combination therapy in septic shock patients is~     expected to deactivate the endothelium and restore vascular integrity, reduce formation of~     microvascular thrombosis and dissolve existing clots in the microcirculation and maintain~     platelet counts, thereby improving platelet-mediated immune function and reducing the risk of~     bleeding. Together this is expected to translate into reduced organ failure and improved~     outcome in patients with septic shock.~      Trial population The trial population is patients >18 years admitted to the ICU with septic~     shock within the last 24h. Eighteen evaluable septic shock patients will be included.~      Trial design This is a single center, randomized (2:1, active:placebo), placebo controlled,~     double-blind investigator-initiated phase IIa trial in patients with septic shock,~     investigating the safety and efficacy of co-administration of Iloprost and Eptifibatide as a~     48h continuous i.v infusion in totally 18 patients.~      All patients will receive standard ICU care including LMWH thrombosis prophylaxis.~      As all patients present at the trial site in an acute, critical condition, scientific~     guardians will co-sign the informed consent form before inclusion. Next-of-kin and the~     patients' general practitioner will co-sign as soon as possible and the patient will provide~     informed consent whenever possible. The active treatment is expected to improve the clinical~     condition of the individual patient and to provide information that may translate into~     improved therapy of future sepsis patients.~      During the study, blood samples will be taken at different time points. Patients will be~     observed and assessed continuously with regards to complications including bleeding. Patients~     will be actively assessed as long as the patient is in the ICU. During the extended follow up~     period at day 30 and 90, contact will be made with the patients to follow up on safety events~     and vital status.~      The trial is conducted in accordance with the protocol and the current regulatory~     requirements and legislation in Denmark.~      Investigational product The active treatment in the trial comprises co-administration of 1~     ng/kg/min Ilomedin® and 0.5 µg/kg/min Integrilin® as 48h continuous i.v infusions. The drugs~     will be purchased and administered according to the product specifications.~      Placebo The placebo in the trial is 0.9% saline as 48h continuous i.v infusion, which will be~     used as placebo for both study drugs. The i.v volume of placebo saline to be administered is~     equal to the administered volume of diluted (in 0.9% saline) active drug.~      Data protection In compliance with the Danish data protection law, the trial will be approved~     by the Danish Data Protection Agency.~      Sponsor of study and financial support This research project is investigator-initiated by the~     trial sponsor and co-investigator Sisse R. Ostrowski and co-investigator Pär I. Johansson in~     collaboration with the principal investigator Morten Bestle.~      It has not received funding from any commercial sponsors.~      Time line Patient recruitment period runs from September 2014 to August 2015. Follow-up data~     on 30-day and 90-day outcome and adverse events will be collected. Initial data analyses will~     be done after completion of 30-day follow-up for all patients. Secondary data analyses will~     be done after completion of 90-day follow-up for all patients.~   "
104096|NCT02204839|"~     The investigators hypothesise that reducing basal insulin dose (Glargine, Lantus,~     Sanofi-Aventis, or Detemir, Levemir, Novo Nordisk), whilst employing current carbohydrate~     feeding and rapid-acting insulin dose recommendations will protect patients with type 1~     diabetes from early- and late-onset hypoglycaemia following evening time exercise.~   "
104097|NCT02204826|"~     Korean Red ginseng (KRG) has long been applied to various diseases as a health-promoting~     herbal medicine in Korea. Many clinical studies of ginseng have been performed to elucidate~     its therapeutic characteristics. KRG has been shown to be effective in many diseases, such as~     cancers, hypertension, Alzheimer's disease, diabetes, acquired immune deficiency syndrome,~     and sexual dysfunction. Several studies have indicated effects of ginseng on improving~     spermatogenesis in animals. The major mechanisms behind these effects were speculated to be~     anti-oxidant and anti-aging effects, as well as modulation of the~     hypothalamus-pituitary-testis axis [7 - 10]. However, there have been no controlled human~     clinical trials to evaluate the effects of KRG on spermatogenesis in patients with male~     infertility.~      Only a small proportion of causes of male infertility are currently curable, including male~     hypogonadal disorders that can be cured by gonadotropic agents, and obstructive azoospermia~     that can be corrected by surgery. In addition, evidence-based medicine has revealed that most~     empirical treatments are ineffective. Similarly, the efficacies of carnitine, anti-estrogens,~     kallikrein, vitamins C and E, and glutathione have not been confirmed.~      Therefore, the investigators investigated the effects of KRG on semen parameters in male~     infertility patients. This is the first placebo-controlled trial to evaluate the therapeutic~     effects of KRG in male patients.~   "
104098|NCT02204813|"~     There is a marked and long-lasting improvement in glucose homeostasis that follows Roux-en-y~     gastric bypass surgery (RYGB) in humans. This improvement has been attributed in large part~     to an intestinal hormone, called GLP-1, that is released into the circulation immediately~     after eating. The purpose of this study is to determine if GLP-1 mediates the beneficial~     effects of RYGB surgery on glucose homeostasis in humans.~   "
104099|NCT02204800|"~     Active surveillance in kidney cancer involves closely observing the tumor with periodic~     imaging studies rather than immediately proceeding to an invasive treatment. This does not~     mean that the tumor is ignored or that future treatment is not necessary, rather it means the~     tumor does not require treatment at this time. On active surveillance, a tumor is closely~     monitored without treatment, however if the tumor changes and reaches a predefined threshold~     that your physician no longer considers safe, your physician will strongly encourage~     treatment.~   "
104100|NCT02204787|"~     The aim of this study is to evaluate the therapeutic efficacy of a neuromodulation technique,~     tDCS (transcranial direct current stimulation) used as a complementary treatment on negative~     symptoms. 60 patients will be randomized into two groups (active tDCS vs sham tDCS) and will~     be assessed after the intervention, 1 and 3 months after.Secondary outcomes shall include~     neuropsychological assessment, general symptomatology, extrapyramidal symptoms and social~     functioning.~   "
104101|NCT02204774|"~     The objective of this prospective cohort study in patients with a known thoracic aortic~     aneurysm is to test the hypothesis that yearly aneurysm progression rate is higher in~     patients with obstructive sleep apnoea (OSA) compared to patients without OSA, and that the~     need for aortic operation or proven or presumed death from aortic rupture or dissection~     happens more often in patients with thoracic aortic aneurysm and OSA compared to patients~     without OSA.~   "
104102|NCT02204761|"~     This pilot clinical trial studies proton beam radiation therapy in treating patients with~     thoracic cancer that has come back and have received prior radiation therapy. Proton beam~     radiation therapy uses high energy protons to kill tumor cells and may cause less damage to~     normal tissue.~   "
104103|NCT02204748|"~     A better understanding of knee joint kinematics is important to explain the premature~     polyethylene wear failures within total knee arthroplasties (TKAs) and to help design a~     prosthesis that most closely approximates the normal knee. Specifically, posterior~     stabilizing (PS) knees have been found to be associated with lower amounts of posterior~     femoral rollback, higher occurrence of reverse axial rotation and increased amount of~     condylar lift-off. The DePuy Synthes Joint Reconstruction's Attune PS fixed bearing (FB) knee~     system has incorporated subtle changes in its design to address restoration of kinematics~     that more closely resemble those of a normal knee. To understand if this design is able to~     effectively restore kinematics in the implanted knee, further in vivo analysis is necessary.~     This pilot study will analyze 5 subjects with the Attune PS FB 3 months post-operatively~     using the University of Tennessee's mobile fluoroscopy unit while performing three daily~     activities, level walking, ramp down and deep knee bend. Since this is a pilot study, there~     is no hypothesis.~   "
104104|NCT02204735|"~     While eating the majority of energy earlier in the day appears to have a positive effect on~     weight and cardiometabolic outcomes, it is not clear how eating earlier in the day influences~     other behaviors that have a circadian rhythm (sleep), other energy balance behaviors~     important for weight loss (physical activity), and self-reported feelings of appetite control~     (hunger and fullness). Thus the purpose of this study is to examine the influence of timing~     of eating on sleep patterns, physical activity, and self-reported feelings of appetite~     control. It is hypothesized that those who eat the majority of their calories earlier in the~     day will have greater weight loss than those who eat the majority later in the day.~   "
104105|NCT02204722|"~     This study is to evaluate efficacy and safety of Imatinib in two groups of patients; all~     patients should be diagnosed less than 3 months as chronic myeloid leukemia in a chronic~     phase. The group A, the reference group, will have 10% or less than 10% of the BCR-ABL level~     after three month dosing and be maintained their dose of 400mg/day. On the other hand, the~     group B, will have more than 10% and the dose will be increased from 400mg/day to 600mg/day.~     The superiority of the group B will be proved by evaluating the MMR rate of these two groups~     after 12 months of administeration of Imatinib.~   "
104106|NCT02204709|"~     The purpose of this study is to determine how eating fish raised to have different levels of~     omega-3 fatty acids will reduce cardiovascular risk markers in people with elevated~     cardiovascular risk.~   "
104107|NCT02204696|"~     The purpose of the study is to determine if tonsillectomy eliminates symptoms of obstructive~     sleep apnea in patients with obstructive sleep apnea and marked tonsillar hypertrophy with~     normal soft palate and uvula length.~   "
104108|NCT02204683|"~     The main goal is to study way that aflibercept injection behaves in the eye and in the body~     of patients with wet macular degeneration, in patients who have had previous vitreous removal~     surgery.~   "
104109|NCT02204670|"~     Background :~      Regular exercise is a cornerstone in the prevention and the management of comorbidities.~     Unfortunately, the metabolic benefit of exercise training is not universal and varies among~     individuals. A main factor likely to explain the exercise training variability is the lack of~     empirical evidence on the determinants of exercise training. A series of muscle-derived~     cytokines have recently been discovered that (1) are released during exercise and (2) exert~     positive effects on peripheral tissues. Irisin is one of these novel myokines and might~     contributes to the metabolic adaptations to exercise training.~      Methods:~      The investigators will perform a pilot cohort study in which obese adolescents will perform~     resistance exercise training for 6 weeks. The main exposure variable will be the acute~     release of irisin during resistance exercise. The main outcome measures will be the change in~     hepatic triglyceride content and glucose area under the curve during a 75g, 2-hour oral~     glucose tolerance test.~      Study Hypothesis:~      The primary overall hypothesis is that the change in plasma Irisin with a single bout of~     exercise will be associated with the metabolic adaptations to 6 weeks of resistance training,~     specifically, the reductions in hepatic triglyceride content and post-prandial glucose~     excursions, in obese adolescents.~   "
104110|NCT02204657|"~     The purpose of this study is to determine if professional Continuous glucose monitoring~     improves glycemic control with less hypoglycaemia in insulin-requiring Gestational Diabetes~     Mellitus~   "
104111|NCT02204644|"~     A study to observe the efficacy and the safety of Flumatinib vs Imatinib as first line~     treatment in patients with newly diagnosed chronic phase chronic myelogenous leukemia.~      Randomized,Open Label,Control~   "
104112|NCT02204631|"~     The goal of this study is to assess the experience of our patients with head and neck cancer~     in regard to the information they receive, their symptoms, and their understanding of their~     diagnosis, to determine ways to improve upon these aspects of patient care in the future.~   "
104113|NCT02204618|"~     The investigators assume that cochlear implants in this indication are not only effective but~     also cost-effective. The investigators' experimental protocol relies on real life therapeutic~     strategy, where a cochlear implant may be proposed once CROS and bone conductions systems~     have failed. Thus, all subjects enrolled in our study will try CROS and bone conduction~     devices. If these trials are ineffective, the remaining subjects will be randomized between~     two arms (cochlear implantation vs 6 months abstention followed by cochlear implantation). A~     comparative cost-utility analysis between the two arms, of medical consequences measured in~     terms of quality of life will identify a preference for a strategy. Specific binaural hearing~     measurements with respect to each treatment option (abstention, CROS, bone conduction device,~     cochlear implant) will also be collected.~   "
104114|NCT02204605|"~     The investigators would like to determine if there is a difference in patient satisfaction~     among patients who have puzzling pain conditions and receive one evaluation from their~     treating physician, and those that receive an evaluation from their treating physician and~     from a group of consulting physicians by video. The investigators expect to enroll 128~     patients at Massachusetts General Hospital.~   "
104257|NCT02202746|"~     The purpose of this study is to determine whether lucitanib is safe and effective in the~     treatment of patients with FGF aberrant metastatic breast cancer, as well as in the treatment~     of patients with biomarker negative (FGF non-aberrant) metastatic breast cancer.~   "
104710|NCT02196805|"~     This study compares the pharmacokinetics characteristics of a single oral intake of an~     imported PROBUCOL tablet(Lorelco)(1*250mg/tablet) with a marketed PROBUCOL tablet (Chang~     Tai)(1*250mg/tablet) in healthy male volunteers to demonstrate they are bioequivalent.~   "
104115|NCT02204592|"~     The term burnout was coined by psychologist Herbert Freudenberger in 1974 in an article~     entitled Staff Burnout in which he discussed job dissatisfaction precipitated by~     work-related stress. A broadly applicable description defines burnout as a state of mental~     and physical exhaustion related to work or care giving activities. A long-standing conceptual~     and operational definition characterized burnout as a triad of emotional exhaustion~     (emotional over extension and exhaustion), depersonalization (negative, callous, and detached~     responses to others), and reduced personal accomplishment (feelings of competence and~     achievement in one's work) In the World Health Organization International Classification of~     Diseases, 10th revision, burnout is defined as a state of vital exhaustion. Although no~     specific diagnosis of burnout is mentioned in the Diagnostic and Statistical Manual of Mental~     Disorders, burnout is a clear syndrome with significant consequences.~      Burnout in health care professionals has gained significant attention over the last several~     years. Given the intense emotional demands of the work environment, clinicians are~     particularly susceptible to developing burnout above and beyond usual workplace stress.~     Residency training, in particular, can cause a significant degree of burnout, leading to~     interference with individuals' ability to establish rapport, sort through diagnostic~     dilemmas, and work though complex treatment decision making. Overall, burnout is associated~     with a variety of negative consequences including depression, risk of medical errors, and~     negative effects on patient safety. The goal of this review is to provide medical educators~     and leaders with an overview of the existing factors that contribute to burnout, the impact~     of burnout, inter specialty variation, and suggestions for interventions to decrease burnout.~   "
104116|NCT02204579|"~     This is an open-label study looking at the effects of NPSP795 (a selective calcium receptor~     antagonist) on activating mutations of the Calcium-sensing receptor in patients with~     Autosomal Dominant Hypocalcemia. Patients with ADH have low blood calcium levels and an~     inappropriately increased renal calcium excretion, decreased renal phosphate excretion, and~     hyperphosphatemia. PTH and blood calcium levels will be tested during and after the IV~     infusion of NPSP795. Concentrations of NPSP795 and length of time of IV infusion will vary~     depending on measured levels of ionized calcium.~   "
104117|NCT02204566|"~     12 patients with Atrial Fibrillation, a kind of irregular heart beat who have undergone Radio~     frequency (RF) ablation will be asked to swallow the capsule.~      As they swallow the capsule, images of the esophagus will be taken to see if the RF ablation~     caused any form of damage to the esophagus considering it being so close to the heart.~      After the capsule has been removed from the mouth, they will be asked about the tolerability~     of the capsule.~   "
104118|NCT02204553|"~     This will be a multi-center, open label, expanded treatment protocol of panobinostat,~     bortezomib and dexamethasone in patients with relapsed and/or refractory multiple myeloma.~     Panobinostat will be administered at a starting dose of 20mg orally three times a week (every~     other day) for two weeks on and one week off, with dose adjustments permitted based on~     observed toxicity. Bortezomib will be administered either intravenously or sub-cutaneously,~     twice a week on days 1 and 4, two weeks on 1 week off. After 8 cycles of treatment, patients~     who have achieved stable disease or better by modified EBMT 1998 criteria may continue~     combination therapy with bortezomib dosing changed to days 1 and 8 of a 21 day cycle for up~     to 48 weeks of therapy. At the end of the treatment period, (48 weeks) patients with stable~     disease or better may continue on therapy at the discretion of their investigator until~     September 2015 or until drug is commercially available, whichever comes first. Patients who~     have not achieved at least stable disease by 8 cycles must discontinue from study treatment.~     Dexamethasone will be administered on the day of and the day immediately following bortezomib~     treatment. Patients will not receive any study treatment during the third week of each cycle.~     Cycles will be defined as 21 days of treatment. Investigators may not add any other~     anti-myeloma agents (with the exception of bisphosphonates) while patients remain on study~     treatment. Patients will remain on study until disease progression, unacceptable toxicity, or~     end of the study~   "
104119|NCT02204540|"~     This study tests the feasibility of having study participants use webcams to participate in~     research studies. The study scientists hypothesize (1) that webcams will be an adequate~     method of detecting a participant's ability to perform a tasks for a clinical trial (e.g.,~     swallowing a pill, eating food) and (2) that a majority of study participants would be~     willing to use a webcam to participate in a research study.~   "
104120|NCT02204527|"~     In patients with type 2 diabetes, the effects on blood pressure of vitamin D has been shown~     to be variable. Thus, the goal of this proposal is to evaluate the effect of vitamin D~     supplementation in patients with type 2 diabetes and hypertension~   "
104121|NCT02204514|"~     The purpose of this study is to assess the pain-relieving effects of surgery for painful~     external snapping hip.~   "
104122|NCT02204501|"~     The primary aim of this Phase 1 study is to evaluate the effect of vapendavir daily doses of~     528 mg daily (QD) and 264 mg twice daily (BID) on the pharmacokinetic (PK) profile of~     midazolam, a cytochrome (CYP) 3A4 substrate. Additionally, the effect of midazolam on the PK~     profile of vapendavir, a PK profile comparison of vapendavir in males and females, as well as~     the safety of vapendavir will also be assessed.~   "
104123|NCT02204488|"~     Trapeziometacarpal osteoarthritis is a common cause of pain and loss of hand function in~     postmenopausal women. Many surgical treatments have been described and recent literature has~     show that the relatively simple trapeziectomy gives equal results and less complications,~     when compared to other techniques such as ligament reconstructions and interpositions. A~     relatively new treatment modality, which has been further developed in recent years is the~     total joint arthroplasty. Randomized prospective trials and long-term results are lacking,~     but prospective cohorts show a faster recovery and good results after one year, without an~     increase in complication rate.~      We hypothesize that a total joint arthroplasty gives a better objective and subjective result~     after one year than a trapeziectomy.~   "
104124|NCT02204475|"~     This is a randomized, multi-site, open-label trial of a fixed-dose combination of Grazoprevir~     (MK-5172) and Elbasvir (MK-8742) versus Boceprevir (BOC) / Pegylated Interferon (P) and~     Ribavirin (R) in treatment-naive and prior treatment failure genotype (GT) 1 hepatitis C~     virus (HCV)-infected participants. The primary hypothesis is that the proportion of~     treatment-naive (TN) and prior treatment failure (PTF) participants treated with grazoprevir~     + elbasvir achieving sustained virologic response (undetectable HCV ribonucleic acid [RNA])~     12 weeks after the end of study therapy (SVR12) will be greater than the proportion of~     BOC/PR-treated participants achieving SVR12.~   "
104125|NCT02204462|"~     Our preclinical studies suggest the capacity of the positron emission tomography imaging~     agent 18F-fluorobenzyl triphenyl phosphonium (FBnTP) to detects early-stage small breast~     tumors (e.g., DCIS), and differentiates benign from malignant masses with better accuracy~     than that obtained by existing breast imaging tools.~   "
104126|NCT02204449|"~     The current study is a randomized controlled trial, being conducted at two hospitals in~     Toronto, Ontario, Canada, involving the randomization of cardiac inpatients into an~     intervention group, in which they will receive mentorship from a volunteer cardiac~     rehabilitation peer mentor, and a control group, in which they will receive usual care.~     Patients in both groups will be tracked to determine if they are referred to cardiac~     rehabilitation and if they enroll in cardiac rehabilitation. We hypothesize that compared to~     cardiac inpatients who receive usual care, those cardiac inpatients who receive cardiac~     rehabilitation peer mentorship will be more likely to be referred to and enroll in cardiac~     rehabilitation.~   "
104127|NCT02204436|"~     Aim of the study was to evaluate by instrumental measurements the depigmenting activity of a~     cosmetic treatment for spotted hand skin; in particular it was investigated the synergic~     activity of an emulsion, with clarifying-antioxidant activity combined with an activator gel,~     with hydration and keratolytic activity.~      Female healthy volunteers aged 45-65 years old, presenting senile lentigo on the hands, were~     included in the study.~      It was also aim of this study to evaluate treatment efficacy and cosmetic acceptability by~     the volunteers and tolerance both by investigator and volunteers.~   "
104128|NCT02204423|"~     Trans-Radial Percutaneous Coronary Intervention (TR-PCI) is rapidly becoming the gold~     standard. This is especially the case in primary Percutaneous Coronary Interventions (PCI),~     where most benefits of the radial approach, such as reduced major bleeding and mortality, can~     be expected. However there is very limited research available looking at the consequences of~     trans-radial access for upper extremity function.~      The main objective of this study is to provide insight in the morbidity with regards to the~     upper extremity surrounding the radial access route in percutaneous coronary interventions.~     Secondary objectives are to provide insight in the consequences for functional status,~     factors influencing and financial costs of this morbidity, to identify subject who might~     benefit from early referral and treatment of this morbidity and to generate hypotheses for~     further clinical research into this matter.~      The investigators hypothesis is that approximately 20% of the population will experience~     upper extremity dysfunction after TR-PCI.~   "
104129|NCT02204410|"~     This study is a 12-week open-label trial to assess the effectiveness of Omega-3 fatty acids~     for deficient emotional self-regulation (DESR) as a supplement to Attention~     Deficit/Hyperactivity Disorder (ADHD) treatment in children and adolescents with Attention~     Deficit/Hyperactivity Disorder. Subjects will be between the ages of 6-17 and will currently~     be on medication for their Attention Deficit/Hyperactivity Disorder but still experience DESR~     traits.~   "
104130|NCT02204397|"~     A proof-of-concept for safety and preliminary clinical efficacy of a combined regimen of~     INGAP-P for β-cell regeneration and ustekinumab for IL-12-23 autoimmune modulation in~     patients with established T1DM.~   "
104131|NCT02204384|"~     To compare the acute effect of soluble fiber intake from foods or supplement after a common~     meal on postprandial plasma glucose and insulin in patients with type 2 diabetes. The~     hypothesis is a meal with a high content of soluble fiber from food determines glycemic and~     insulinemic response similar to a meal with a high content of soluble fiber from supplement~     sources.~   "
104132|NCT02204371|"~     This study will investigate whether pazopanib can reduce epistaxis and improve anaemia in~     subjects with hereditary haemorrhagic telangiectasia (HHT) at a dose that is well tolerated.~     The study will have 2 parts. Part A will be an open label, dose-escalation study in which up~     to 4 cohorts of approximately 6 subjects each will receive increasing doses of pazopanib for~     a maximum of 12 weeks. The dose in the first cohort will be 50mg per day and the maximum dose~     in a cohort will be 400 mg per day. Dose escalation will not occur as planned if the~     predefined safety stopping criteria are met or at least 4 subjects in a cohort have~     demonstrated efficacy (as measured by epistaxis, haemoglobin, transfusion or iron infusion~     requirements). If efficacy is demonstrated in Part A with an acceptable safety profile, Part~     B will be initiated to further define the optimal dose(s) including dose duration/schedule~     and to provide further support for the proof of mechanism. Approximately 15 subjects will~     participate and will be randomised to active or placebo in a ratio of 3:2. This part of the~     study will be double-blind.~   "
104133|NCT02204358|"~     Study of the treatment of infertility caused by severe intrauterine adhesions or endometrial~     dysplasia by collagen scaffold loaded with autologous bone marrow stem cells, and to provide~     clinical evidence for the treatment of uterine infertility~   "
104134|NCT02204345|"~     A multi-center Phase Ib/II study of the combination of RO5479599 with carboplatin and~     paclitaxel once in every 3 week (q3w) regimen to evaluate the safety and tolerability.~   "
104135|NCT02204332|"~     The purpose of this study is to determine efficacy and safety of cabazitaxel administration~     in patients with colorectal cancer resistant to standard treatment.~   "
104136|NCT02204319|"~     The objectives of this pilot study are to demonstrate effectiveness of application of the~     Erchonia Laser (manufactured by Erchonia Corporation),a non-invasive, non-significant risk~     low level laser red diode light therapy device, in providing relief of pain symptoms in~     patients with provoked and non- provoked vulvar vestibulitis; to reduce the frequency of use~     of oral medications to manage pain symptoms; and to reduce the debilitating affect vulvar~     vestibulitis has on the patient's daily activities, relationships and emotional well-being.~   "
104137|NCT02204306|"~     In gastric cancer patients treated with 5-FU and cisplatin, higher tumor TS levels were~     associated with a less favorable response (29% vs. 68%; p=0.024). Similarly, in a study in~     which patients were treated with high dose 5-FU, patients with high TS expression had a~     response rate of only 12.5%. Conversely a response rate of 92.9% was observed in patients~     with low tumor TS expression. A longer but not statistically significant survival advantage~     was observed in patients with the TSER*2 allele compared with the TSER*3/*3 patients.~     Additionally, a review by Patel et al. identified approximately 20 gastric cancer studies~     that have found a positive association between TSER genotype and clinical response (in either~     direction). Therefore, the primary goal of this proposal is to prospectively genotype~     patients, select patients with good risk TSER genotypes (TSER*2*/*2 or *2/*3) and treat~     them with a standard 5-FU containing regimen (FOLFOX) in order to improve clinical outcomes,~     while randomize patients with the poor risk TSER genotype (*3/*3) to either the standard~     5-FU containing regimen or another non-5-FU-based regimen (docetaxel/cisplatin).~   "
104139|NCT02204280|"~     Definite diagnosis of diabetic nephropathy is currently based on renal biopsy findings. In~     most cases, however, the diagnosis can be reliably made in patients with macroalbuminuria in~     the presence of diabetic retinopathy.Microalbuminuria is often used as a prognostic marker in~     type 1 diabetes, because approximately 50% of type 1 diabetes patients with microalbuminuria~     will eventually develop diabetic nephropathy. Conversely, microalbu- minuria is of much less~     value as a marker in DM because it has a variety of causes, including hypertension. Thus,~     additional markers are needed to identify patient groups with a high risk of developing overt~     diabetic nephropathy. The aims of this study is checking urine UbA52 levels with ELISA to~     identify its significance in the diagnosis of diabetic nephropathy.~   "
104140|NCT02204267|"~     Investigator-initiated prospective randomized multicentre study to uncover the true burden of~     paroxysmal atrial fibrillation in a representative population of acute stroke patients~     without known atrial fibrillation.~   "
104141|NCT02204254|"~     Rosacea is a chronic facial disfiguring dermatosis characterized by different stages like~     flushing, erythema, telangiectasia and papulo-pustular lesions. Recommended treatments~     include topical (metronidazole) and systemic (doxycycline) antibiotics with only a suspensive~     effect. The bipolar radiofrequency (RF) with Elos system (infrared light) is a device~     emitting an electromagnetic current inducing an increase in temperature when applied on the~     skin, potentiated by infrared light. The monopolar RF has already been used in rosacea on a~     small number of cases with positive and prolonged results. RF with Elos system has been~     evaluated on erythemato-telangiectasic rosacea with encouraging results. Demodex folliculorum~     (DF) is a long transparent mite which asymptomatically parasitizes pilosebaceous follicle of~     normal human skin sometimes responsible of inflammatory facial dermatoses. The prevalence and~     density of DF are increased in rosacea, and DF is suspected to play a role in the~     pathogenesis of rosacea. DF is sensitive to heat, and the investigators hypothesize that~     radiofrequency treatment may affect the survival of the mite and should be effective to treat~     papulopustular rosacea.~   "
104142|NCT02204241|"~     This protocol is a phase I/II multicenter study designed to assess the safety and the~     efficacy of the proposed combinations as up-front treatment in elderly Multiple Myeloma (MM)~     patients.~   "
104143|NCT02204228|"~     The Integra® TITAN™ Reverse Shoulder System (TRS) is a semi-constrained total shoulder~     construct. When used under the conditions and purposes intended the TRS will relieve pain and~     restore some functional joint motion to the affected shoulder. The purpose of this study is~     to assess the short, mid and long term outcomes of the TITAN™ Reverse Shoulder System.~   "
104144|NCT02204215|"~     Intensive care unit acquired weakness (ICU-AW) is common and dramatically affect recovery.~     The purpose of this study is to determine whether electric acupuncture therapy is effective~     in the treatment of ICU-AW especially in the patients receiving mechanical ventilation with~     sepsis or multiorgan system failure.~   "
104145|NCT02204202|"~     The purpose of this research study is to gain understanding of the basic responses of the~     lungs to inflammation and specifically if there may be a better way to detect graft~     inflammation using non-invasive methods as well as to determine the effectiveness of~     immunosuppressive treatment regimens in preventing acute rejection in lung transplant~     recipients.~   "
104146|NCT02204189|"~     The purpose of this study is to determine whether TongFuSan is effective in the treatment of~     acute pancreatitis with gastrointestinal dysfunction.~   "
104147|NCT02204176|"~     The rate of adult obesity in the United States has increased more than two times since 1970,~     and the rate of child-teen obesity has increased by four times. One of the antecedents of~     obesity is an inactive lifestyle. Exercise has been known to be associated with increases in~     both physical and mental health by increasing longevity, preventing risk of obesity, coronary~     heart disease, and hypertension, and increasing self-esteem and overall quality of life. The~     broad aim of the current study is to investigate the effectiveness of psychoeducational~     training to increase exercise activity initiation and maintenance in young adults.~      The goal of this study is to compare three training approaches for college students to~     increase exercise behavior. One approach provides general information on the different types~     of exercises and benefits of engaging in exercise behavior after an initial questionnaire~     assessment session. A second approach includes the general exercise information and~     questionnaire assessment as well as training on how to create specific goal intentions (i.e.,~     implementation intentions) to aid in exercise initiation. A third approach uses all the~     components of the second approach but also tests the utility of a personality-informed module~     by incorporating concepts from the theory of learned industriousness. It is expected that the~     third approach will be the most effective in helping participants initiate and maintain their~     exercise activities during the course of the study duration.~   "
104148|NCT02204163|"~     Evaluate the efficacy and safety after treatment of Eutropin® inj. compared to Genotropin® in~     infants/toddlers with Prader-Willi syndrome~   "
104149|NCT02204150|"~     The main purpose of this research is to test the feasibility and tolerability of the tethered~     capsule Optical Frequency Domain Imaging (OFDI) screening probe in healthy subjects, patients~     with Barrett's Esophagus and Eosinophilic Esophagitis.~   "
104150|NCT02204137|"~     The purpose of this research study is to look at the use of a series of questionnaires~     evaluating risk for falls in order to collect information that might be used to develop a~     larger study aiming to recognize who is more at risk for falls and how to best intervene to~     prevent falls in older adults with cancer.~   "
104151|NCT02204124|"~     The Whipple procedure is the standard method for therapy for cancerous tumors, inflammation,~     and stenosis (narrowing) near the head of the pancreas. This is a prospective study to assess~     whether or not use of the Thunderbeat™ device may decrease blood loss and postoperative~     morbidity (the presence of illness or disease). The findings will then be compared to~     patients whose Whipple procedure will be performed using conventional dissection and~     hemostasis techniques.~   "
104152|NCT02204111|"~     The primary objective of the study is to compare quality of life (QoL) between patients~     suffering from soft tissue sarcoma, receiving a multidimensional intervention with those~     receiving standard treatment.~   "
104258|NCT02202733|"~     The primary goal of the study is to use an iterative process to develop and refine a~     skill-based cooking intervention to decrease the consumption of energy from foods prepared~     away from home for evening meals, decrease energy intake, and promote a healthy weight in~     parents and children aged 3-10 years.~   "
104153|NCT02204098|"~     The purpose of this research study is to find out about the safety of injecting the gene~     (DNA) for mammaglobin-A into people with breast cancer. The DNA used in this study was~     purified from bacteria and contains the gene for mammaglobin-A. Mammaglobin-A is a protein~     that is highly expressed by breast cancer cells. Injection of mammaglobin-A DNA may be a way~     to generate an immune response to breast cancer cells. There is evidence that an immune~     response may be a way to fight cancer. In addition to evaluating the safety of the~     mammaglobin-A injection, this study is also looking at the immune response that the~     participant's body has after each injection.~   "
104154|NCT02204085|"~     This research study is studying a targeted therapy known as GO-203-2C as a possible treatment~     for with acute myeloid leukemia (AML) both alone and in combination with decitabine.~     GO-203-2c targets cancer cells, while leaving healthy cells unaffected.This is a Phase I/II~     clinical trial. A Phase I clinical trial tests the safety of an investigational intervention~     and also tries to define the appropriate dose of the investigational intervention to use for~     further studies.~   "
104155|NCT02204072|"~     The overall aim of the trial is to investigate the safety and anti-tumour activity of an~     experimental drug BI 836845 taken together with the prostate cancer drug, enzalutamide,~     compared to enzalutamide given alone, in castrate resistant prostate cancer (CRPC) patients~     that have previously been treated and failed on docetaxel and abiraterone treatments.~     Initially, a tolerability and safety phase (phase Ib escalation) will be performed to confirm~     the maximum tolerated dose (MTD), or recommended doses of both BI 836845 and enzalutamide~     that can be taken together.~      Once the MTD, or recommended phase II dose, have been determined an expansion cohort will~     also be explored (phase Ib expansion) in CRPC patients already taking enzalutamide and have a~     rise in prostate serum antigen (PSA) levels. Patients may not have received prior docetaxel~     or abiraterone. Patients in this cohort will receive the MTD, or recommended phase II dose,~     of BI 836845 and enzalutamide determined in the phase Ib escalation phase.~      The randomised trial (phase II) will be an open label, parallel group study design in a 1:1~     ratio to which patients will receive either BI 836845 plus enzalutamide (Arm A) at the~     MTD/recommended doses, or enzalutamide alone (Arm B).~      In all parts of the trial safety, anti-tumour activity will be assessed, in addition to~     circulating tumour cells (CTC), prostate serum antigen (PSA) response and progression, and~     determination of Overall Survival (OS).~   "
104156|NCT02204059|"~     The primary objectives of this study is to assess the safety and tolerability of~     intravenously (i.v.) administered 186 Rhenium-isotope (186Re)-labelled bivatuzumab and to~     investigate the biodistribution and pharmacokinetics of 186 Re-labelled bivatuzumab in~     patients with non-small cell lung cancer (NSCLC)~   "
104157|NCT02204046|"~     The primary objectives of this study were to assess the safety and tolerability of~     intravenously (i.v.) administered 186Rhenium (186Re)-labelled bivatuzumab and to investigate~     the biodistribution and pharmacokinetics of 186Re-labelled bivatuzumab in patients with~     adenocarcinoma of the breast~   "
104158|NCT02204033|"~     The general aim of the present study was to assess the safety and tolerability of~     intravenously administered Technetium 99m (99mTc) and Rhenium-186 radionuclide (186 Re)~     -labelled hMAb BIWA 4, to confirm preferential accumulation in the tumour of 99mTc - labelled~     hMAb BIWA 4, to determine the maximum tolerated radiation dose of 186 Re-labelled hMAb BIWA 4~     and to propose a safety dose for phase II development.~   "
104159|NCT02204020|"~     Despite improvements in outcomes after Hematopoietic Cell Transplantation (HCT) for Acute~     Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), the risk of relapse remains high~     and is the most common cause of mortality after HCT. Moreover, treatment options for relapse~     after HCT are limited. Strategies to reduce relapse with maintenance therapy in patients who~     are at high risk are needed to improve survival. 5-aza is a hypomethylating agent that has~     shown immune modulating properties that may enhance the graft-versus-leukemia (GVL) effect,~     including upregulation of tumor-associated antigen and costimulatory molecule expression.~     Moreover, 5-aza has properties that suggest protection against graft-versus-host disease~     (GVHD) as well. Preliminary data shows that it is well tolerated and effective in clinical~     use for the treatment of AML or MDS relapse after HCT, as well as for maintenance therapy.~     This study will evaluate the use of 5-aza for maintenance after HCT in patients with AML or~     MDS with risk factors that are associated with a high risk for relapse.~   "
104160|NCT02204007|"~     This is an observer-blinded prospective randomized clinical trial to define the efficacy of a~     new technology developed at the Cleveland Clinic to improve the positioning of the acetabular~     shell in total hip arthroplasty.The proposed study will enroll patients that have consented~     to total hip arthroplasty with or without screw fixation for treatment of hip pathology. This~     treatment is standard of care. Patients will receive standard of care pre- and post-operative~     care and placement of standard of care implants all of which are commercially available and~     FDA approved for general use for the clinical indications used in these patients. The only~     difference in treatment between the groups will be the use of a surrogate bone model to help~     assist the surgeon visualize the ideal placement of the acetabular component. Diagnostic~     testing performed specifically related to this study consists of obtaining one pre-operative~     and one post-operative CT scan. The post-operative scan is to be performed within two weeks~     of surgery.~      The investigators predict that those patients with 3D imaging and bone model will have better~     acetabular shell placement than those with standard preoperative planning.~   "
104161|NCT02203994|"~     Spasticity is the most problematic self-reported secondary medical problem in patients with~     spinal cord injury. It has the potential to negatively influence quality of life through~     restricting activities of daily living. Problematic spasticity can cause pain and fatigue,~     disturb sleep, contribute to the developement of contractures and pressure ulcers, and has a~     negative effect on patients morbidity. For this reason there is enormous interest in~     therapeutic interventions addressing to decrease spasticity in persons with spinal cord~     injury. Recently, studies reported positive effects of extracorporeal shock wave therapy on~     spasticity in patients with stroke, focal limb dystonia and cerebral palsy. To date, no~     studies are published, assessing the effect of extracorporeal shock wave therapy on focal~     spasticity in patients with spinal cord injury.~      The purpose of this study is to investigate the effect of a one-time ESWT on lower limb~     spasticity in patients with an incomplete spinal cord injury.~   "
104162|NCT02203981|"~     To determine optimal cut-off value for the TopQ cut-off on the Maestro and 3D OCT-2000.~   "
104163|NCT02203968|"~     Trauma is the leading cause of death in people 44 years of age or younger. After major~     trauma, such as following high-speed motor vehicle collision, bleeding coupled with clotting~     defects is responsible for most of deaths in the first hours of hospital admission. Of note,~     these bleeding-related deaths are potentially preventable. Accordingly, the initial~     in-hospital management of severely injured patients focuses on stopping bleeding, replacing~     blood loss and correcting clotting defects.~      Recently, animal and human research demonstrated that one of the major clotting defects~     following injury and bleeding is the drop in blood levels of fibrinogen (a clotting factor),~     which is detected on hospital admission in severely injured patients. These low fibrinogen~     levels are associated with increased blood transfusion and death. However, in North America,~     the standard of care for replacing low fibrinogen requires the use of cryoprecipitate, which~     is a frozen blood product with long preparation time, and similarly to other blood products,~     carries the risk of viral transmission and transfusion complications. Alternately, many~     Europeans countries where cryoprecipitate has been withdrawn from the market due to safety~     concerns, use fibrinogen concentrate. Fibrinogen concentrate undergoes pathogen inactivation,~     which is a process to eliminate the risk of transmitting viruses, bacteria and parasites, is~     likely a safer and faster alternative to cryoprecipitate. In Canada, fibrinogen concentrate~     is licensed for congenital low fibrinogen only.~      Although preliminary data suggest that fibrinogen supplementation in trauma is associated~     with reduced bleeding, blood transfusion, and death, the feasibility, safety and efficacy of~     early fibrinogen replacement remains unknown. We proposed to conduct a feasibility randomized~     trial to evaluate the use of early fibrinogen concentrate against placebo in injured patients~     at our trauma centre.~      A pilot trial is necessary to demonstrate the feasibility of rapidly preparing, delivering,~     and infusing fibrinogen concentrate as an early therapy to prevent excessive bleeding in~     trauma. This feasibility trial will provide preliminary safety and clinical outcome data to~     inform the design of larger trials; which ultimately aims to prevent bleeding-related deaths~     in the trauma population.~   "
104164|NCT02203955|"~     The main objective is to compare prebiotic therapy with placebo for the prevention of~     pouchitis after closure of diverting ileostomy in patients with an ileal pouch anal~     anastomosis. This study will also characterize the effects of prebiotics on the fecal~     microbiota and fecal microbial metabolites and correlate these effects with the primary~     outcome of development of pouchitis.~   "
104165|NCT02203942|"~     Vaginitis is the most common condition encountered in the gynecologist's office and is most~     commonly caused by bacerial vaginosis (BV), vulvovaginal candidiasis (VVC) and Trichomonas~     vaginalis (TV). Establishing the correct etiology of symptomatic vaginitis can be~     challenging, and the evaluation of vaginitis by physicians is often substandard.~      The investigators will determine whether NAAT testing will improve the diagnosis of vaginal~     infections including bacterial vaginosis (BV), vulvovaginal candidiasis (VVC) and Trichomonas~     vaginalis (TV).~   "
104166|NCT02203929|"~     Knowledge of the natural history and progression of macular holes is mainly limited to the~     studies from the pre-optical coherence tomography era. By observing macular holes~     preoperatively we are able to determine the extent of the preoperative macular hole~     progression.~      At our institution macular holes are treated in an elective setting. The majority of macular~     holes undergo a 2-step sequence of phacoemulsification and intraocular lens implantation~     followed by vitrectomy.~      We wish to observe the effect of time and cataract surgery on the progression of macular~     holes prior to vitrectomy.~   "
104167|NCT02203916|"~     The purpose of this study is to compare the antihypertensive effect of azilsartan medoxomil~     versus placebo in Korean adults with essential hypertension.~   "
104168|NCT02203903|"~     This Phase I dose-escalation trial is designed to evaluate the safety of administering~     rapidly-generated multi-antigen-specific T lymphocytes, to HSCT recipients (Arm A) or future~     HSCT recipients (Arm B) for the treatment or relapsed or refractory hematopoietic~     malignancies, to determine if event-free survival (EFS) at six months after HSCT is improved~     with TAA-L administration at six months after HSCT for acute myeloid leukemia and MDS (Arm~     C).~   "
104169|NCT02203890|"~     This study will provide the researchers with an opportunity for the investigation of the~     biomarkers and different human biology component variable interactions in children;~     information that can generate new correlations between markers not known at the moment.~      Regarding their analysis, variation could have multiple connotations. A categorical that~     refers to a specific state, established with a diagnostic standard. And a numerical,~     referring to a range or the absolute value limits in a continuous spectrum; this research~     will allow us to express variability in the distance amplitude of the obtained values level,~     as well as classifications or categories previously established in the possible cases.~      OBJECTIVES PRINCIPAL OBJECTIVE~      To estimate the inter and intra-individual variety in a selected series or biological~     variables determinant of growth, body composition, infection, oxidation, inflammation and~     hydration, in preschool children sharing the same institutional-based diet.~      SPECIFIC OBJECTIVES~        -  To determine the inter and intra-individual variation of growth in preschool children,~          with a similar diet, who attend Secretariat of Beneficial Works of the First Lady system~          daycare centers and to compare between semi-urban and rural.~        -  To describe the inter-individual variation of the red blood cells circulating mass in~          preschool children, with a similar diet, who attend day care centers and to compare~          between semi-urban and rural.~        -  To determine the inter-individual variation of systemic and intraintestinal oxidation in~          preschool children, with a similar diet, who attend daycare centers and to compare~          between semi-urban and rural.~        -  To describe the inter-individual variation of systemic and intraintestinal inflammation~          in preschool children, with a similar diet, who attend daycare centers and to compare~          between semi-urban and rural.~        -  To determine the inter and/or intra-individual variation of urinary tract infection and~          gastrointestinal parasite infestation in preschool children, with a similar diet, who~          attend daycare centers and to compare between semi-urban and rural.~        -  To describe the inter and intra-individual variation of the hydration status in~          preschool children, with a similar diet, who attend daycare centers and to compare~          between semi-urban and rural.~        -  To explore intra-individual associations in variables of the same research component or~          different component variables.~   "
104170|NCT02203877|"~     To evaluate the effect of the consumption of Lactobacillus fermentum CECT5716 on mastitis~     incidence.~   "
104171|NCT02203864|"~     Evaluation of safety and tolerability of four intradermal injections given at two week~     intervals. In addition the efficacy of transferrinfection was determined by quantifying~     Interleukin 2 (IL-2), which was locally produced by the implanted, transfected allogenic~     melanoma cells at the injection sites. Further determination of tumor specific and clinical~     host responses induced or augmented by the treatment were determined.~   "
104172|NCT02203851|"~     The primary objective of the study is to investigate long-term safety and efficacy of BI~     655066/ABBV-066/risankizumab, in patients with moderate to severe chronic plaque psoriasis,~     during open-label treatment.~   "
104173|NCT02203838|"~     This is a Phase 3, open label study administering RBP-7000 in the treatment of patients with~     schizophrenia. Study will assess the long-term safety and tolerability of RBP-7000~     subcutaneous (SC) injections in subjects with schizophrenia and to continue collecting~     clinical outcome data with RBP-7000 SC injections in subjects with schizophrenia using the~     Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression-Severity Illness~     (CGI-S) scale.~   "
104174|NCT02203825|"~     This Phase I clinical trial is evaluating chimeric-antigen receptor (CAR) T-cells (CM-CS1 T~     cells) which recognize NKG2D-ligands on the surface of cancer cells. This study evaluates the~     safety and feasibility of administering a single intravenous dose of CM-CS1 CAR T-cells to~     patients with AML, MDS-RAEB and Multiple Myeloma.~   "
104175|NCT02203812|"~     The oral cavity is mostly influenced by general health. The oral microbiota which is as~     complex as the gastro-intestinal or vaginal microbiota are considered to be difficult~     therapeutic targets. The effects of probiotics in different fields of health care have~     resulted recently in the introduction of probiotics for oral healthcare. Probiotics have been~     clinically proved effective in different fields of oral healthcare such as halitosis, oral~     candidiasis and tooth decay. They have also been inducted in the field of periodontal~     healthcare because of the current views on the etiology of plaque- related periodontal~     inflammation.~   "
104176|NCT02203799|"~     Many children who are allergic to peanuts do not outgrow their allergy and have very severe~     allergic reactions called anaphylaxis. Symptoms of anaphylaxis include difficulty breathing,~     decreased blood pressure, hives, and lip or throat swelling after exposure to an allergen. A~     severe allergic reaction can lead to death if not treated appropriately.~      The purpose of this study is to find out if there is a way to treat children with peanut~     allergy to help lower the risk of severe allergic reactions and also cause them to lose their~     allergy to peanuts. The approach that will used for this study is a process called~     desensitization.~      Oral immunotherapy involves eating gradually increasing amounts of a food over several~     months. This is a research study because at this time peanut oral immunotherapy (OIT) is~     investigational. Peanut OIT (study drug) is investigational because it is not currently~     approved for clinical use by the Food and Drug Administration. There are no alternative safe~     and effective treatments for peanut induced allergic reactions other than peanut avoidance~     and treatment with medications.~   "
104177|NCT02203786|"~     To determine if:~        1. pathological gambling is similar to psychostimulant addiction as reflected by parallel~          roles for D1 and D2 receptors in gambling and stimulant reinforcement.~        2. these parallel roles are linked with gambling pathology or if they are evident in both~          gamblers and controls.~   "
104178|NCT02203773|"~     This is a Phase 1b, open-label, non-randomized, multicenter study to evaluate the safety and~     pharmacokinetics of orally administered ABT-199 combined with decitabine or azacitidine and~     the preliminary efficacy of these combinations. In addition, there is a drug-drug interaction~     (DDI) sub-study only at a single site, to assess the pharmacokinetics and safety of ABT-199~     in combination with posaconazole.~   "
104179|NCT02203760|"~     Study design:~      This study is a prospective, randomized, open-label, multicenter phase II trial in order to~     determine progression-free survival of patients with refractory or relapsed metastatic~     uterine leiomyosarcomas or other metastatic uterine tumours.~      Indication:~      Relapsed or metastatic uterine leiomyosarcomas or carcinosarcomas~      Randomization:~      Patients with uterine leiomyosarcomas will be randomized in a 1:1-fashion to receive the~     following therapy~        -  Arm A: Pazopanib 800 mg orally once daily plus Gemcitabine 1000 mg/m2 i.v. over 30 min d~          1 and d 8 q3w or~        -  Arm B: Pazopanib 800 mg orally once daily Patients with uterine carcinosarcomas will be~          treated according to Arm A.~      Planned number of patients:~      87 patients with uterine leiomyosarcomas 20 patients with uterine carcinosarcomas~      Treatment schedules:~      Patients with uterine leiomyosarcomas will be randomized in a 1:1-fashion to receive the~     following therapy • Arm A (experimental arm / combination arm): Pazopanib 800 mg orally once~     daily plus Gemcitabine 1000 mg/m2 i.v. over 30 min d 1 and d 8 q3w or~      • Arm B (control arm / monotherapy arm): Pazopanib 800 mg orally once daily Patients with~     uterine carcinosarcomas will be treated according to Arm A.~      Planned treatment duration per subject:~      Patients continue on study treatment until disease progression, death, unacceptable toxicity~     or withdrawal of consent for any reason.~   "
104180|NCT02203747|"~     The purpose of this study is to evaluate visual distortions reported by pseudophakic~     patients.~   "
104181|NCT02203734|"~     This project will investigate the effects of massage therapy on depressed pregnant women. The~     investigators expect that massage therapy will improve blood flow from the mother to the~     fetus and reduce prematurity and depression.~   "
104182|NCT02203721|"~     The purpose of this clinical trial is to evaluate the safety and effectiveness of the TECNIS~     Symfony Extended Range of Vision IOL.~   "
104183|NCT02203708|"~     Borderline Personality Disorder (BPD) is characterized by a pervasive pattern of instability~     of interpersonal relationships, self-image and emotions as well as marked impulsivity. When~     patients have children, they are at high risk of severe emotional and relational disturbances~     (withdrawal, low self-esteem, depression, suicidal thoughts). In addition, studies support~     the effectiveness of parental guidance group to reduce emotional and behavioral difficulties~     of children. To our knowledge there are no programs directed to mothers with BPD who received~     a controlled evaluation.~      From experience with parental guidance, data from the observation of children of patients~     with BPD and psychosocial programs directed to patients BPD, we have built for preventive~     intervention. The Supportive Program for Mothers with BPD (SuPMother-B) consists of 10 group~     sessions providing information (education, childcare, care specific to BPD) and promotes~     mother-child interactions (observation, games).~      Purpose: Compare the effect of a program (SuPMother-B) group, of 10 sessions, offered to~     mothers with a BPD in addition to a minimal intervention (diagnostic announcement and~     provision of health care resources) on behavior withdrawal of children at 6 months compared~     to a group of mothers receiving only minimal intervention.~      Primary outcome: Difference at 6 months between the experimental and control groups on scores~     on the assessment scale withdrawal (Alarm Distress Baby (ADBB)).~   "
104184|NCT02203695|"~     The primary hypothesis of this study is that outcomes for patients with biochemically~     recurrent prostate cancer following radical prostatectomy will be improved by the addition of~     enzalutamide for 6-months compared to standard-of-care salvage radiation therapy to allow for~     further study in the definitive phase III setting. This study builds on the prior success of~     high-dose bicalutamide (for 24 months) when combined with salvage external radiation therapy~     (XRT), while using a newer more potent anti-androgen for a shorter duration of time (6~     months) in an effort to minimize adverse effects.~   "
104185|NCT02203682|"~     The aim of this study is to evaluate the effects of subantimicrobial dose doxycycline (50~     mg/d), administered for 12 weeks, on patients with mild Graves' Orbitopathy (GO).~   "
104186|NCT02203669|"~     The purpose of this study is to demonstrate the benefits of a structured~     occupational/physical therapy program on upper extremity morbidity for patients who have~     received bilateral breast reconstruction in comparison to a home therapy program and no~     post-operative therapy.~      Hypothesis: Patients who engage in therapist-supervised occupational therapy following~     bilateral breast reconstruction have less upper extremity morbidity than those patients who~     complete a home therapy program or no therapy program.~   "
104187|NCT02203656|"~     The purpose of this study is to test the feasibility of interventions to accelerate recovery~     of muscle mass and function in older adults following acute hospitalization.~   "
104259|NCT02202720|"~     Describe the Richmond Agitation Sedation Scale (RASS) values corresponding to the values of~     Minimum alveolar concentration of sevoflurane during sedation of patients in ICU~   "
104188|NCT02203643|"~     This study will evaluate the safety and the efficacy of carfilzomib combined with~     cyclophosphamide and dexamethasone (CCyd) or lenalidomide and dexamethasone (CRd) followed by~     autologous transplantation ASCT or 12 cycles of carfilzomib combined with dexamethasone and~     lenalidomide for patients eligible for ASCT with newly diagnosed multiple myeloma. As a~     secondary endpoint this study will evaluate the best maintenance treatment between~     lenalidomide and lenalidomide combined with carfilzomib.~      Four hundred seventy-seven patients, males and females aged > 18 years, enrolled in several~     sites, will take part in this study.~      The duration of the study is approximately 5 years.~   "
104189|NCT02203630|"~     Septic shock is a condition that is marked by severe infection causing hypotension requiring~     vasopressors to maintain adequate perfusion to vital organs. The Surviving Sepsis campaign,~     an international organization formed for the purpose of guiding the management of sepsis and~     septic shock, currently recommends norepinephrine as the first-choice vasopressor for septic~     shock. Phenylephrine, a vasopressor FDA-approved for use in septic shock, is recommended as~     an alternative vasopressor when septic shock is complicated by tachyarrhythmia to mitigate~     cardiac complications. This recommendation is based solely on experience with no scientific~     evidence to support this recommendation.~      The investigators will conduct an open-label randomized controlled trial (RCT) directly~     comparing phenylephrine and norepinephrine, two FDA-approved vasopressors that are both used~     in clinical practice for the management of septic shock. The investigators will perform this~     study with a population of patients that have septic shock to complete the following aims:~      Aim 1: Determine the incidence of tachyarrhythmias.~      Aim 2: Determine which vasopressor, phenylephrine or norepinephrine, is associated with a~     lower heart rate.~      Aim 3: Determine which vasopressor, phenylephrine or norepinephrine, is associated with a~     higher incidence of new tachyarrhythmias.~      Aim 4: Determine which vasopressor, phenylephrine or norepinephrine, is associated with less~     time in tachyarrhythmia.~      Aim 5: Determine which vasopressor, phenylephrine or norepinephrine, is associated with fewer~     complications, including cardiac complications.~      The investigators hypothesize that in this setting, phenylephrine will improve the management~     of septic shock when used as a first choice vasopressor by:~        1. Decreasing the mean heart rate~        2. Decreasing the incidence of new tachyarrhythmias~        3. Decreasing the amount of time spent in tachyarrhythmia for patients who develop new~          onset and recurrent tachyarrhythmias~        4. Decreasing the number of cardiac complications~   "
104190|NCT02203617|"~     The Baby Books Project tests whether embedding educational information into baby books can~     improve the health and wellbeing of first-time mothers and their young children.~   "
104191|NCT02203604|"~     This phase II trial studies how well high-dose aldesleukin and ipilimumab works in treating~     patients with stage III-IV melanoma that cannot be removed by surgery. Biological therapies,~     such as aldesleukin, may stimulate or suppress the immune system in different ways and stop~     tumor cells from growing. Monoclonal antibodies, such as ipilimumab, interfere with the~     ability of tumor cells to grow and spread. Giving high-dose aldesleukin together with~     ipilimumab may work better in treating patients with melanoma.~   "
104192|NCT02203591|"~     The objective of the study is to demonstrate the antimicrobial efficacy of the 3M CHG/IPA~     Prep on skin flora of the abdomen and inguinal regions of human subjects.~   "
104193|NCT02203578|"~     This pilot clinical trial studies romidepsin in treating patients with graft-versus-host~     disease (GVHD) that has not responded to treatment with steroids. Romidepsin may be an~     effective treatment for graft-versus-host disease caused by a bone marrow or stem cell~     transplant.~   "
104194|NCT02203565|"~     This pilot clinical trial studies Dakin's solution in preventing radiation dermatitis in~     patients with breast cancer undergoing radiation therapy. Radiation dermatitis is a skin~     condition in which the affected skin becomes painful, red, itchy, and blistered. Dakin's~     solution may help reduce dermatitis caused by radiation therapy.~   "
104195|NCT02203552|"~     This randomized clinical trial studies how well minocycline hydrochloride works in reducing~     chemotherapy induced depression and anxiety in patients with stage I-III breast cancer.~     Minocycline hydrochloride may prevent changes in memory and thinking and improve the quality~     of life of breast cancer patients receiving chemotherapy.~   "
104196|NCT02203539|"~     The purpose of this study is to determine if an exposure to light in the evening has a~     positive influence on physical performance regarding endurance, strength and reaction time.~   "
104197|NCT02203526|"~     BACKGROUND:~        -  Primary CNS lymphoma (PCNSL) is a rare subtype of diffuse large B-cell lymphoma.~        -  The outcome for patients with this diagnosis is significantly worse than for that of~          systemic DLBCL. Most treatment approaches in the past have included high dose~          methotrexate and radiation treatment.~        -  Most PCNSLs appear to be of activated B-cell (ABC) origin.~        -  Ibrutinib is an inhibitor of Bruton s tyrosine kinase (BTK) and effective for systemic~          DLBCL of ABC origin.~        -  We propose doing a study in which ibrutinib is combined with a novel chemotherapy~          platform called dose adjusted temozolomide, etoposide, doxil, dexamethasone, ibrutinib,~          rituximab (DA-TEDDI-R).~      OBJECTIVE:~      - Identify the maximum tolerated dose (MTD) of ibrutinib or the dose that achieves adequate~     CSF concentrations, whichever comes first, when ibrutinib is given with DA-TEDDI-R.~      ELIGIBILITY:~        -  Newly diagnosed or relapsed/refractory PCNSL.~        -  Age greater than or equal to 18 years.~        -  No pregnant or breast-feeding women.~        -  Adequate organ function (defined in protocol).~      STUDY DESIGN:~        -  This is a phase 1 study of 40 patients.~        -  The study will have two components.~             1. Phase 1: MTD of ibrutinib will be identified or the dose at which ibrutinib~               achieves a concentration of less than or equal to 100 nM in the CSF, when given in~               combination with DA-TEDDI-R immuno-chemotherapy, whichever comes first.~             2. Expansion cohort: Safety and tolerability of the regimen in relapsed/refractory or~               previously untreated PCNSL (DLBCL type) will be assessed at the final ibrutinib~               dose with DA-TEDDI-R in 10 patients. Secondary objectives will be PFS and OS.~   "
104198|NCT02203513|"~     Background:~        -  All cells go through cycles which allow them to divide. In normal cells, Chk1 and Chk2~          (Chk1/2) stop cell division at various points to allow any damage to DNA to be repaired.~        -  When Chk1/2 are not present, cells stop dividing and eventually die. LY2606368 blocks~          the Chk1/2 proteins.~        -  Researchers hope that by blocking Chk1/2, it will cause tumor cells to die, thereby~          shrinking tumors.~      Objective:~      - To see if LY2606368 helps shrink tumors in patients with certain breast, ovarian or~     prostate cancers.~      Eligibility:~      - Patients at least 18 years old with breast or ovarian cancer. They must have a mutation in~     BRCA1/2 genes for group 1, high grade serious ovarian cancer without BRCA1/2 mutation for~     group 2, or triple negative breast cancer without BRCA1/2 mutation for group 3, or prostate~     cancer with or without BRCA1/2 mutation for group 4.~      Design:~        -  Participants will be screened with a medical history and physical exam. They will have~          blood tests, an electrocardiogram (ECG) heart test, scans, and X-rays. They will have a~          piece of their tumor removed at entry (CT-assisted biopsy).~        -  Study Day 1: Participants will have a physical exam and blood drawn. They may have a CT~          scan of the chest, abdomen, and pelvis.~        -  Day 1 and Day 15 of each 28-day cycle: Participants will receive the study drug through~          an IV.~        -  Vital signs will be checked before and after. An ECG will be done within 1 hour after.~        -  Day 15 and Day 28: Participants will have a physical exam, blood drawn, and a 12 lead~          ECG.~        -  Cycle 1: Participants will have weekly phone calls and blood draws. Participants may~          have another CT-assisted biopsy at the end of cycle 1.~        -  Cycle 2 and beyond, blood will be drawn every other week for routine blood tests.~        -  Participants will have an after-study visit with a physical exam and blood tests.~          Participants may have another biopsy when they progressed on treatment. They will have~          scans of the chest, pelvis, and abdomen and a 12 lead ECG.~   "
104199|NCT02203500|"~     The objectives of this study are to compare the steady state pharmacokinetics of lacidipine~     with and without the co-administration of telmisartan and to compare the steady state~     pharmacokinetics of telmisartan with and without the co-administration of lacidipine~   "
104203|NCT02203448|"~     A Multi-centre, Prospective, single-arm post market clinical follow up study (PMCF) of the~     FACET WEDGETM spinal system to assess outcomes in subjects with chronic low back pain due to~     Degenerative Disc Disease (DDD), facet joint disease and/or pseudo arthrosis post anterior~     instrumentation. The objective of this study is to assess outcomes following implantation of~     the FACET WEDGE spinal system when used to provide fixation of lumbar motion segments.~      The primary objective of this study is to determine the rate of re-operations at the index~     level(s).~      The secondary objectives of this study are to confirm the safety and performance of the~     device and to collect patient reported outcome data.~   "
104204|NCT02203435|"~     This study aimed to retrospectively examine patients evaluated by the Code Blue team on a~     Code Blue call in our hospital between 2009 and 2013.~      Primary outcome: an examination of the survival rates and demographic data of the patients~     evaluated as an emergency by a Code Blue call in the period 2009-2013.Secondary outcome: to~     determine the rates of false Code Blue calls, the clinics giving Code Blue calls and the~     relationship between the times of Code Blue calls and mortality.Inclusion criteria: patients~     throughout the whole hospital for whom a Code Blue form was completed and who were evaluated~     by the Code Blue team on a Code Blue call.~      Exclusion criteria: patients who refused treatment~   "
104205|NCT02203422|"~     The project was undertaking by Qilu Hospital of Shandong University and other 5 well-known~     hospitals in China. In order to report the efficacy and safety of recombinant human~     thrombopoietin combining with cyclosporin A for the treatment of adults with refractory~     immune thrombocytopenia (ITP), compared to cyclosporin A monotherapy.~   "
104206|NCT02203409|"~     The purpose of this research is evaluate the results with laparoscopic ALPPS procedure in a~     single center. The validity, feasibility and limitations were assessed objectively through~     our clinical prospective study.The investigators expect laparoscopic ALPPS is safe, effective~     and feasible.~   "
104207|NCT02203396|"~     Severe acquired aplastic anaemia (SAA) is a bone marrow failure disease characterized by~     pancytopenia and a hypocellular bone marrow. The corn pathophysiological mechanism is the~     destruction of hematopoietic stem/progenitor cells mediated by auto-reactive effector T~     cells. Immunosuppressive therapy with horse antithymocyte globulin (ATG) plus cyclosporine~     (CSA) is currently the standard of treatment in patients with aplastic anaemia who are not~     eligible for bone marrow transplantation and with response rates from 40% to 70%. Previous~     studies showed that horse ATG (hATG) is apparently more effective than rabbit ATG (rATG) as~     the latter has higher treatment related mortality (TRM). Unfortunately hATG is unavailable in~     China, so we conduct a optimized standard treatment (9 days protocol) of rATG plus CSA and~     Levamisole (LMS) Sequential maintaining (termed Optimized Standard Protocol, OSP) for severe~     aplastic anemia. This prospective study is designed to evaluate the efficacy and safety of~     Optimized Standard Protocol as first line therapy in newly diagnosed severe aplastic anemia~     patients.~   "
104208|NCT02203383|"~     Central Sleep Apnoea (CSA) affects up to half of patients with severe heart failure and is~     associated with a poor prognosis. CSA is manifest as episodes of deep breathing interspersed~     with very shallow or absent breathing and is largely due to an exaggerated response to rising~     carbon dioxide in the blood, which normally drives how hard we breathe. Cardiac~     Resynchronization therapy (CRT), in which a pacemaker is implanted to improve co-ordinated~     contraction of the heart, has been shown to reduce the severity of CSA in some patient~     groups. We aim to determine whether this improvement is due to normalization of the body's~     response to carbon dioxide in the blood. Our hypothesis is that CRT improves CSA by~     normalizing the brain's response to carbon dioxide.~   "
104209|NCT02203370|"~     Aim oft he study is to compare two different devices for cerebral oximetry (FORE-SIGHTTM~     Monitor (CAS Medical Systems, Branford, Connecticut, USA and INVOSTM Somanetics, Troy,~     Michigan, USA) in patients undergoing surgical carotid thrombendarterectomy (cTEA) with~     crossclamped internal carotid artery (ACI). All procedures will be performed in regional~     anesthesia, therefore the patients will be awake and direct neurological examination during~     the procedure will be possible, giving information how the drop in cerebral saturation~     (measured with INVOS and FORESIGHT both on the same patient) correlates with any clinical~     symptoms.~      We expect to see a difference in the total drop and in the delay of the drop of cerebral~     oxygen saturation, making it possible to detect varieties in specificity and sensitivity of~     both devices compared to neurologic examination in the awake patient.~   "
104210|NCT02203357|"~     The objective of this study is to evaluate the immunogenicity and Anti-HBV antibody~     persistence of hepatitis B vaccine with different doses and schedules. Hepatitis B vaccine~     with the regimens of 20μg, 0-1-6 mon and 60μg,0-1 or 0-2 mon will be administered to young~     adults, and the comparative immunogenicity among the three groups will be measured at 1 mon~     post-a series vaccination, 1- and 2-year after the first dose of the regimen. Furthermore,~     the safety of hepatitis B vaccine with different doses and schedules will also be evaluated.~   "
104222|NCT02203201|"~     The most frequent diseases caused by wheat ingestion are T cell-mediated disorders, i.e.~     celiac disease and immunoglobulin E (IgE)-mediated allergic reactions. However, besides~     celiac disease and wheat allergy, there are cases of gluten reactions in which neither~     autoimmune nor IgE-mediated allergic mechanisms are involved. These are generally defined as~     GS or Not-celiac wheat sensitivity (NCWS). Typically, NCWS diagnosis is made by exclusion,~     and an elimination diet and an open challenge (i.e., the monitored reintroduction of~     gluten-containing foods) are most often used to evaluate whether health improves or worsen~     with the elimination or reintroduction of gluten in the diet, respectively. In some~     circumstances, it is very difficult to distinguish between NCWS and celiac disease. The~     presence of positive celiac disease specific serum antibodies (anti-tissue transglutaminase~     (anti-tTG), and anti-endomysium (EmAs) antibodies) is of paramount importance to pose the~     diagnosis. However, it is well known that the frequency of a positive serology is dependent~     by the severity of the intestinal damage. Consequently, patients with less severe histology~     damage (Marsh 1) can have negative serum antibodies. Previous studies had demonstrated that~     EmAs are produced by the intestinal lymphocytes and previous data from our group showed that~     EmAs assay in the culture medium of the intestinal biopsies has higher diagnostic accuracy~     than serum EmAs in diagnosis. Therefore, the aims of our study are to evaluate the~     clinical-serologic-histology course of NCWS patients, showing positive EmAs assay in the~     culture medium of the duodenal biopsies at the time of the first evaluation, and the~     adherence to a gluten-free diet in NCWS patients after a previous full evaluation and a NCWS~     diagnosis based on double-blinded placebo-controlled (DBPC) challenge.~   "
104260|NCT02202707|"~     The purpose of this study is to preliminarily determine whether the frequency and/or severity~     of vasomotor symptoms (VMS) at baseline, and then after symptom reduction with gabapentin,~     relates to various cardiovascular control measures.~   "
110118|NCT02126098|"~     The purpose of this study is to observe the clinical manifestation, Lab findings including~     chest CT scans, pathological findings and outcomes in chinese patients with pulminary~     vasculitis.~   "
104211|NCT02203344|"~     Studies have shown that prolonged deep sedation is associated with adverse clinical outcomes~     in adult intensive care unit (ICU) patients. The revised guidelines for management of pain,~     agitation and delirium by the Society of Critical Care Medicine in 2013 also recommended that~     adult ICU patients should be maintained at a light level of sedation. The key point in light~     sedation strategy is the assessment of depth of sedation. At present, sedation is monitored~     mainly by the subjective clinical score systems, such as the Ramsay Scale, the Riker's~     Sedation-Agitation Scale (SAS) and the Richmond Agitation-Sedation Scale (RASS). However, the~     subjective and intermittent nature of these scales instruments has limited their application~     in light sedation algorithm. Consequently, objective and continuous measurement of the level~     of sedation would be more desirable in clinical practice. In recent years, objective measures~     of brain function have been of great interests in the evaluation of sedation level, and~     bispectral index (BIS) has been the most investigated instrument.~      Several studies compared BIS with subjective sedation scales in adult ICU patients, and~     yielded conflicting results. The different approaches to select BIS value may be the most~     important reason for these inconsistent agreements between BIS and subjective sedation~     scales. A formal scheme of subjective assessment of the depth of sedation and level of~     consciousness should incorporate exerting verbal and physical stimuli and observation of the~     patient's subsequent responses. Our primary aim is to clarify the diagnostic accuracy of BIS~     in detecting early deep sedation against the reference standard of subjective scale~     instrument. We hypothesize that BIS monitoring will provide accurate, subjective and~     continuous evaluation of deepen sedation.~   "
104212|NCT02203331|"~     Purpose of the study is to test efficacy and safety of BAY98-7196 intravaginal ring as a new~     treatment option for patients with endometriosis-associated pelvic pain~   "
104213|NCT02203318|"~     The aim of this study is to verify whether the hypertrophy of contralateral testis may~     predict the absence of the non-palpable testis in the boys younger than 24months of age.~     According to the previous studies of other countries, the large size of the contralateral~     testis of the nonpalpable testis has positive correlation woth the weak viability of the~     affected testis. We are going to evaluate this hypothesis with prospective study. 3 groups~     are going to be enrolled into this study ; non-palpable testis group(Group1), palpable but~     not normally descended testis group(group2) and control group(group3). The size of testis~     will be measured with Ultrasound and the length, width and the height will be measured before~     surgery at outpatient department. For the group 1 & 2, the viability of the affected testis~     will be evaluated and compared after surgery. In addition the comparison with normal control~     group is also going th be conducted.~   "
104214|NCT02203305|"~     The primary goal of this project is to determine whether subjects with Single-Sided Deafness~     (SSD) experience an improvement in speech perception, localization, and quality of life with~     a cochlear implant as compared to an unaided listening condition.~   "
104215|NCT02203292|"~     TRAHT is a pilot randomized clinical trial designed to evaluate safety and feasibility of two~     red blood cells transfusion thresholds in moderate or severe traumatic brain injured patients~   "
104216|NCT02203279|"~     Purpose: The purpose of this study is to evaluate three hard relining materials after 3 and 6~     months of use with mandibular complete dentures. The effect of hard relining materials on~     supporting tissues and patients' satisfaction will also be assessed.~      Materials and Methods: 36 complete edentulous patients who already have maxillary dentures~     and complaining of instable mandibular dentures will be invited to participate in this study.~     Mandibular dentures will be relined randomly by one of three relining materials: two~     chairside relining materials (Tokuyama Rebase II Fast, Tokuyama Dental Co, Japan), and~     (Flexacryl Hard, Lang Co, USA) and one heat cured acrylic resin (Vertex, Dental technology~     Co, Holland).~      The color stability of relining material, peeling, and the effect on supporting tissue will~     be assessed by two separate prosthodontists after 3 and 6 months of follow up. In addition,~     patients will be asked to grade there overall satisfaction on a Visual Analogue Scale (VAS)~     ranging from 0 to 100.~   "
104217|NCT02203266|"~     The purpose of this trial is to discover whether providing feedback to patients from a device~     that records when and how well a patient uses a Seretide Diskus inhaler will lead to:~        -  Improved compliance with prescribed inhaler use~        -  Improved technique of inhaler use~        -  A reduction in respiratory health related outcomes caused by poor inhaler compliance and~          usage.~        -  An improvement in patient quality of life scores~   "
104218|NCT02203253|"~     This study was aimed to evaluate efficacy and tolerability of thalidomide in improving~     prevention of chemotherapy-induced delayed nausea and vomiting in chemotherapy-naive patients~     after highly emetogenic chemotherapy.~   "
104219|NCT02203240|"~     The purpose of this study is to determine the impact of consuming cocoa on blood glucose~     levels, glucose metabolism, and other markers of pre-diabetes in overweight and/or obese~     individuals. Our hypothesis is that consumption of cocoa improves insulin sensitivity and~     glucose metabolism in subjects at risk for developing type-2 diabetes.~   "
104220|NCT02203227|"~     The purpose of this study is to investigate the efficacy and safety of dietary supplements~     (BioTurmin, BioTurmin-WD and MaQxan) on cotinine level and oxidative stress marker in chronic~     smokers having mild to moderate hyperlipidemia after 30 and 60 days of intervention.~   "
104221|NCT02203214|"~     The purpose of this study is to evaluate the safety and effectiveness of the Ligamys~     technique for the treatment of acute ruptures of the anterior cruciate ligament in a~     multicenter routine clinical setting. To conduct a long-term follow-up of the case series as~     a post-market product surveillance endeavor.~   "
104223|NCT02203188|"~     Sjogren's Syndrome is an autoimmune condition in which the body attacks its own glands in the~     body. Some of these glands are responsible for providing lubrication for the eye. As a~     result, individuals with Sjogren's Syndrome often experience dry eye. Recently, a study had~     shown that dry eye symptoms were improved by removing debris and old skin cells along the~     eyelid margin. This technique is called eyelid debridement-scaling. The purpose of this study~     is to determine how well this technique works in improving dry eye signs and symptoms in~     individuals with Sjogren's Syndrome.~   "
104278|NCT02202473|"~     The purpose of this study is to evaluate the efficacy of Oxymatrine plus Lamivudine~     Combination Therapy and whether it could lower the incidence of Lamivudine long-term~     resistance compared to Lamivudine Monotherapy.~   "
104279|NCT02202460|"~     Patients suffer from Serious Psychosis may have variation in immunological factors,BDNF and~     MRI.~   "
104224|NCT02203175|"~     Pain on injection of propofol is a comman problem. The investigators planned to evaluate the~     effect of propofol-fentanyl mixture on propofol injection pain and compare it with fentanyl~     pretreatment and control groups.~      Following ethics committee approval, 150 ASA I,II patients (18-65 yr) undergoing general~     anesthesia were enrolled to this study. Exclusion criteria were communication difficulty,~     psychiatric, neurologic disorders and history of allergy. Patients were randomly assigned to~     one of tree equal groups. Before the anesthesia induction, Group C (Control, n=50) and group~     M (mixture, n=50) received 5 ml isotonic saline, group F (fentanyl, n=50)received 2micgr/kg~     fentanyl. 10 seconds after the study drugs had been given, a standart question about the~     comfort of the injection was asked to the patient. The investigators used the verbal rating~     scale (VRS) for evaluation of propofol injection pain. Statistical analyses were performed~     with Student's t and Fisher's exact tests; p value <0,05 was considered significant.~      Demographic data was similar among the groups (table I) In group M, the number of the~     patients having propofol injection pain was significantly lower compared to groups F and C~     (p<0,001 for both) None of the patients in groups F and M experienced severe pain whereas 24~     patients (48%) had severe pain in group C (p<0.001 for both).~      This study shown that fentanyl-propofol mixture is more effective compared to both fentanyl~     pretreatment and placebo in preventing propofol injection pain.~   "
104225|NCT02203162|"~     Although electronic cigarettes (e-cigs) are now widely used, very little information exists~     regarding the effect of electronic cigarette use (vaping) on the respiratory system. The aim~     of this study is to evaluate the acute effect of one e-cig vaping session (30 puffs 30~     seconds apart) on cough reflex sensitivity in healthy adult nonsmokers.~   "
104226|NCT02203149|"~     This is a two-part study of grazoprevir (MK-5172) + elbasvir (MK-8742) in Japanese~     participants with chronic hepatitis C virus (HCV) genotype 1 (GT1). Part I is a dose-finding~     study; in Part II, participants will be randomly assigned to receive grazoprevir at the dose~     determined in Part I in combination with elbasvir. The primary study hypothesis is that the~     percentage of treatment-naïve participants in the Immediate Treatment Arm of Part II who~     achieve sustained viral response at 12 weeks after the end of all treatment (SVR12) will be~     greater than the reference rate of 75%. A separate study arm for cirrhotic participants will~     also be included in Part II; these participants will receive grazoprevir at the determined~     dose in combination with elbasvir.~   "
104227|NCT02203136|"~     The goal of this research study is to improve detection of cancer outside of the bladder~     through genetic testing and improved imaging.~   "
104228|NCT02203123|"~     -  There is no definite tool for measurement of dehydration in children~        -  Subjective clinical dehydration scale is considered as valuable scoring system, but it~          cannot be reliable among clinicians sometimes.~        -  Some authors found Inferior vena cava/Aorta ratio can be a objective marker for~          dehydration~        -  However, there is no evidence of correlation between clinical dehydration scale and~          inferior vena cava/aorta ratio~        -  We will observe correlation between clinical dehydration scale and inferior vena~          cava/aorta ratio and change of the ratio according to hydration with intravenous normal~          saline infusion.~   "
104229|NCT02203110|"~     The purpose of the study is to determine if the clinical course of pneumonia is more severe~     when both, bacterial and viral pathogens are find as possible causative agent and how does it~     affect treatment.~   "
104230|NCT02203097|"~     Purpose:~      The purpose of this study is to examine the effect of different carbon-dioxide concentrations~     on cerebral CO2 sensitivity and the resistance and stiffness of systemic arteries during~     anesthesia with target-controlled infusion anesthesia using intravenous propofol. Propofol is~     a widely and commonly used intravenous anaesthetic, that is mainly used for the induction of~     general anesthesia and the maintenance of total intravenous anaesthesia (TIVA).~      Changes in the velocity of cerebral blood flow and arterial stiffness due to the different~     exhaled carbon-dioxide concentrations will allow us to conclude how propofol affects these~     parameters during the course of the narcosis.~      Instruments:~      An ultrasound device called transcranial doppler (TCD) is used to measure the velocity of~     blood flow within a main artery located inside the skull.~      A tonometry device named SphygmoCor is used to assess the pressure wave proceeding in the~     radial artery, from which the stiffness of the systemic vessels can be concluded.~      Measurements:~      - Examinations with the ultrasound and tonometry devices are carried out once before the~     operation, three times during the intervention, with different exhaled CO2 values and once~     after the operation is completed.~      Hypothesis:~      - Propofol alters cerebral carbon-dioxide sensitivity and the stiffness of systemic arteries~     during TCI anaesthesia.~   "
104231|NCT02203084|"~     Anyone who practices clinical medicine will understand that socially disadvantaged children~     will have worse health outcomes, no matter what the underlying condition might be. There is~     limited prospective data on the effects of social deprivation on children in BC and there is~     none concerning the effects of social deprivation on children with chronic diseases. In order~     to generate relevant data for those who manage children with chronic diseases in BC, the~     investigators wish to perform an observational study of the relationship between~     questionnaire-derived social variables and measured outcomes in children with cystic~     fibrosis, type 1 diabetes, and chronic kidney disease.~      Our working hypothesis is that there is an association between social determinants of health~     (income, education, race) and health outcomes in children with cystic fibrosis, type 1~     diabetes and chronic renal failure, that is independent of access to health care (assessed by~     distance to nearest specialty clinic and number of clinic visits in the last year).~   "
104251|NCT02202824|"~     The objective of our study was to determine the extent to which contextual information about~     the circumstances of intimate partner violence affects participants' responses to questions~     about their personal attitudes toward intimate partner violence.~   "
104252|NCT02202811|"~     The purpose of this study is to understand how behaviors and the effects of the body's~     internal clock (called the circadian pacemaker) affect the control of the heart and blood~     pressure.~      People with Obstructive Sleep Apnea (OSA) are hypothesized to have altered circadian~     amplitudes in certain key indices of cardiovascular (CV) and an abnormally advanced circadian~     phase in some of the same key indices of CV risk. The investigators hypothesize that such~     changes, taken together, may explain the different timing of heart attack and sudden cardiac~     death in OSA.~   "
104232|NCT02203071|"~     Subjects will be selected among the investigators' patient population who are already~     scheduled to receive a marrow stimulating procedure (MSP), with or without the addition of~     BioCartilage.~      During the surgical operation for MSP, a portion of the patient's blood is taken out and used~     to form a patch to cover a cartilage defect of the knee. Currently it is considered standard~     of care to either form the patch using only a portion of the patient's blood, or form the~     patch using a portion of the patient's blood combined with an FDA-approved augmentation such~     as BioCartilage.~      This study will collect outcomes data and MRI for patients that are undergoing MSP with and~     without BioCartilage augmentation, then compare the data between those who received~     BioCartilage and those who did not.~      The primary endpoint is to determine whether subjects receiving a marrow stimulating~     procedure (MSP) augmented with BioCartilage have improved outcomes (measured using quality of~     life indicators, functional outcomes, and MRI) compared to subjects who receive MSP without~     the use of BioCartilage.~   "
104233|NCT02203058|"~     Background: Dynamic hyperinflation (DH) is an important factor leading to dyspnea and~     consequent limitations in functional capacity of chronic obstructive pulmonary disease (COPD)~     patients. It has not been completely elucidated whether pursed-lips breathing (PLB) is able~     to minimize DH and its effects on exercise tolerance in these patients. The aim of this study~     was to evaluate the acute effect of PLB on DH and functional capacity in patients with COPD.~      Design: Randomized cross-over study. Setting: The study will be conducted in an outpatient~     pulmonary rehabilitation program in Florianópolis, Brazil.~      Subjects: Twenty-five patients with COPD (16 men, mean age 64 (7) years, FEV1=41.7 (14.7)%~     predicted, BMI=27.6 (5.13)kg/m2).~      Interventions: Patients will randomly perform two six-minute walk tests with and without PLB~     (6MWTPLB and 6MWTNon-PLB) and two Glittre-ADL tests with and without PLB (TGlittrePLB and~     TGlittreNon-PLB).~      Main measures: At baseline and immediately after the tests, the inspiratory capacity (IC)~     will be assessed by the slow vital capacity (SVC) maneuver.~   "
104234|NCT02203045|"~     The overall goal of this study is to determine the effects of intraoperative tourniquet use~     during total knee arthroplasty (TKA), compared to TKA without the use of a tourniquet~     (NOTQT), for strength and functional recovery following simultaneous bilateral TKA. During~     the procedure, each patient will receive tourniquet-assisted TKA (TQT) on one lower extremity~     while the contralateral lower extremity undergoes TKA without the use of a tourniquet~     (NOTQT), except for briefly during component cementation. Tourniquets are commonly used in~     TKA to improve visualization of the surgical field and limit blood loss. However, studies~     suggest that tourniquet use may be associated with higher rates of medical complications and~     poor functional outcomes, including increased swelling, decreased muscle strength and altered~     neuromuscular activity. We will measure strength, voluntary muscle activation, and other~     functional outcomes for each lower extremity at 4 time points (preop; inpatient (24-72 hrs~     after surgery); 3 weeks; and 3 months following TKA). We hypothesize that lower extremities~     in the NOTQT group will demonstrate improved strength and performance when compared to lower~     extremities in the TQT group.~   "
104235|NCT02203032|"~     The purpose of this study is to evaluate the efficacy and safety of guselkumab (CNTO 1959) in~     the treatment of participants with moderate to severe plaque-type psoriasis (scaly skin rash)~     who had inadequate response to ustekinumab.~   "
104236|NCT02203019|"~     Patients with infections in their blood often become very sick. These patients are usually~     put in an intensive care unit for careful observation and treatment. These patients may~     develop a low blood pressure, lung failure, and kidney failure. When these problems develop,~     care becomes quite complicated. Patients with lung failure often need help with a breathing~     machine to make certain that the breathing is adequate. The machine helps keep the oxygen~     level high enough for healthy tissues. When patients are placed on the machine for breathing~     they require a tube to be placed into lungs. This can be quite uncomfortable. These patients~     need sedation to help them tolerate the uncomfortable breathing tube and other parts of their~     routine necessary care. This study will compare two drugs (dexmedetomidine and propofol)~     which are frequently used for sedation in intensive care patients. Clinical studies suggest~     that these drugs are both effective and safe. The main question is whether or not one of the~     drugs is better in a patient with a blood infection. This study will try to determine that.~     Our main goal is to see whether or not patients on one particular drug come off the breathing~     machine faster than patients on the other drug. These drugs are not experimental drugs and~     are approved by the Food and Drug Administration. There is no placebo drug being used in this~     study. All patients in this study will receive the best possible care based on their medical~     condition.~   "
104237|NCT02203006|"~     The purpose of this study is to improve our knowledge concerning HIV infection, treated or~     not, in the current conditions of care to optimize it.~   "
104238|NCT02202993|"~     This is a dose-escalation study that will assess the safety and determine the maximum~     tolerated dose (MTD) of mibefradil dihydrochloride, a partially selective T-type calcium~     channel blocker, combined with hypofractionated radiation therapy (RT) in subjects with~     recurrent glioblastoma multiforme (GBM).~   "
104239|NCT02202980|"~     This study will evaluate the antiviral efficacy, safety, and tolerability of combination~     therapy with oral regimens for the treatment of chronic hepatitis C virus (HCV) infection.~   "
104253|NCT02202798|"~     Over the past 5 years, there has been a change in clinical practice with the use of cuffed~     instead of uncuffed endotracheal tubes in infants and children. Two manufacturing companies~     have recently introduced syringe-like devices to the market which allow the measurement of~     the intracuff pressure. This study proposes to prospectively compare the intracuff pressure~     from these devices with the gold standard technique (manometer).~   "
104254|NCT02202785|"~     The purpose of this study is to assess the efficacy, safety and tolerability of MLN0264 in~     patients with advanced or metastatic guanylyl cyclase C (GCC)-positive adenocarcinoma of the~     pancreas.~   "
104255|NCT02202772|"~     The investigators intend to evaluate the safety and toxicity proﬁle of intravesically~     administered multidrug regimen of Cabazitaxel, Cisplatin and Gemcitabine in treatment~     refractory Transitional Cell Carcinoma.The investigators propose to conduct a combined phase~     I trial to assess the safety, toxicity, and efﬁcacy of a novel multidrug intravesical regimen~     consisting of Cabazitaxel, Gemcitabine, and Cisplatin (CGC) in the treatment of BCG resistant~     non-muscle invasive urothelial carcinoma of the bladder. This phase I trial will have a~     combined dose and cycle-escalation scheme with enrollment of up to 24 patients.~   "
104240|NCT02202967|"~     Anti-inflammatory tablets (non-steroidal anti-inflammatory drugs) continue to be used~     commonly worldwide to relieve pain caused by arthritis. Likewise, aspirin is used by many~     patients in order to prevent blood clots. Despite their desired benefits, these medicines can~     cause internal bleeding from the digestive system. The source of this bleeding can be obvious~     (overt), or obscure and thought to come from the small intestine. Obscure bleeding can show~     as anemia due to lack of iron in the blood. Small intestine ulcers are now easily diagnosed~     using an endoscope the size of a big pill (video capsule endoscopy). Small bowel ulcers are~     not related to stomach acid and therefore do not heal using remedies usually taken to stop~     acid formation. A different drug, misoprostol, consists of a chemical (prostaglandin) that is~     usually lacking in patients using aspirin or anti-inflammatory drugs. Misoprostol is licenced~     to heal stomach and duodenal ulcers in patients using these drugs. Our hypothesis is that~     misoprostol might be effective in healing small bowel ulcers as suggested by pilot studies;~     however, such works only included small numbers of patients, did not include control groups~     and both patients and investigators knew the nature of the tablets used. To test this~     hypothesis, we propose to compare misoprostol to a dummy tablet. The numbers of subjects to~     be studied have been calculated using established statistical methods~   "
104241|NCT02202954|"~     In the situation of motor limitations that people often experience after stroke, current~     health systems cannot provide for the daily amount and duration of high intensity muscle~     stretch and motor training that would be required over protracted periods to involve muscle~     and brain plasticity. For patients with sufficient cognitive abilities, Guided~     Self-rehabilitation Contracts allow implementing stretch and training at high intensity and~     may result in meaningful functional improvement in chronic stages, as long as discipline~     persists over at least a year span.~      This single blind control protocol will evaluate Guided Self-rehabilitation Contracts as~     against conventional therapy in the community, for a one year duration in persons with~     chronic hemiparesis after stroke.~   "
104242|NCT02202941|"~     This clinical trial is aimed to show a procalcitonin-guided treatment algorithm may shorten~     duration of antibiotic therapy safely and cost-effectively in sepsis patients of Korean ICU.~   "
104243|NCT02202928|"~     The purpose of this study is to evaluate the efficacy of autologous tumor lysate-pulsed~     dendritic and cytokine-induced killer cells (DC-CIK) for colorectal cancer (CRC).~   "
104244|NCT02202915|"~     This study examines a training program for clinicians who work in mental health clinics that~     serve children with OCD. We will provide clinician training in conducting exposure-based~     treatments for children with OCD. The purpose of the project is to test the use of a new tool~     to enhance training in exposure-based treatments for clinicians. Therapists will receive~     training and oversight from the researchers regarding the treatment procedures and use of the~     new tool. All children enrolled in the study will receive treatment by clinicians who are~     participating in this study. Therapists and youth will be recruited separately for the study~     and will be assigned to work together.~   "
104245|NCT02202902|"~     This study aims at evaluating the myocardial triglyceride content and cardiac structure and~     function, using 1H magnetic resonance spectroscopy and cardiac magnetic resonance imaging, in~     patients with Cushing's syndrome before and after treatment and in age-, sex- and BMI-matched~     healthy volunteers. The investigators make the hypothesis that Cushing's syndrome patients~     compared to healthy subjects present with excess lipid storage in cardiac myocytes,~     reversible upon correction of hypercortisolism.~   "
104246|NCT02202889|"~     School based educational intervention to educate on bone health among Hispanic, Asian or~     non-Hispanic white girls between 10-13 years with end points of knowledge gained, calcium~     intake and bone density in . The hypothesis was that the educational program would increase~     knowledge, improve dairy food and calcium consumption and enhance bone health in this~     population. A secondary hypothesis was that lactose maldigestion would be an impediment to~     improved dairy food consumption.~   "
104247|NCT02202876|"~     Cystic fibrosis-related diabetes (CFRD) occurs in almost 20% of teens and 50% of adults. The~     investigators' long term goal is to determine the cause of CFRD in order to translate this~     knowledge into therapies aimed at preventing CFRD. Since CFRD and type 2 diabetes share~     several clinical features and since oxidative stress is a key factor in the development of~     type 2 diabetes, the investigators explored the role of oxidative stress in CFRD. The~     investigators discovered a unique CF biochemical signature that they believe could be~     implicated in the development of CFRD. The investigators found that glucose ingestion in CF~     teens and young adults causes an acute and profound systemic redox imbalance to the oxidizing~     state. The degree of redox imbalance was quite severe and would be expected to damage the~     insulin producing cells as these cells are particularly vulnerable to oxidative stress. Thus,~     these findings could prove to be a critical factor in the pathogenesis of CFRD. This proposal~     will test the hypothesis that glucose-induced redox imbalance is an intrinsic, metabolic~     defect in CF. In addition, because CF people are required to consume a high calorie diet to~     maintain their weight, the investigators also hypothesize that certain high caloric foods~     will recapitulate the redox imbalance induced by ingesting glucose and thus hasten the~     development of CFRD. Specifically, the investigators aim to:~        -  Determine whether young children with CF have glucose-induced redox imbalance~        -  Determine whether eating a meal with a high glycemic index induces acute redox imbalance~   "
104248|NCT02202863|"~     Lifestyle modifications, including healthy food intake, exercise, and suppression of tobacco~     smoking, constitute the most powerful tool to fight chronic diseases. Antioxidants and fiber,~     two components of Mediterranean diets, are key functional elements for healthy eating and~     nutrition. We prepared flour from wine grape pomace (WGPF), a rich source of antioxidant and~     fiber, to be used as an ingredient for functional foods and as a dietary supplement to~     increase the intake of dietary fiber and bioactive compounds. WGPF was obtained from red~     grapes (Cabernet Sauvignon variety, Chile). The byproduct of pressing crushed grapes after~     alcoholic fermentation was dried, grounded and stored. The purpose of this study is to~     determine the effects of red wine grape pomace flour intake on glycaemia, plasma lipid~     profile, plasma antioxidants (vitamin C and E), oxidative stress and inflammatory markers.~   "
104249|NCT02202850|"~     Determine which remission criterion at Month 6 predicts remission at Month 12 the best.~   "
104250|NCT02202837|"~     Defining Which Remission Criterion at Month 6 Predicts Remission at Month 12 in a Real Life~     Clinical Practice, in a Cohort of Rheumatoid Arthritis Patients Treated with Etanercept~   "
104261|NCT02202694|"~     Aim:~      To assess the feasibility of application of culturally-adapted CBT (CaCBTp) for use in~     Pakistan.~      Design:~      Randomized Control Trial~      Setting:~      Psychiatry Departments of General Hospitals in Karachi.~      Participants:~      A total of 36 patients with a diagnosis of psychotic disorder will be randomized to a~     psychological intervention or treatment as usual arm.~      Intervention:~      Culturally Adapted Cognitive Behavioral Therapy (CBT)~      Outcome measure:~      Positive and Negative syndrome scale (PANSS) Psychotic symptoms Rating Scales (PSYRATS)~   "
104262|NCT02202681|"~     The study is being done to assess the tolerability and feasibility of a tethered OFDI capsule~     to image the duodenum.~      A total of 24 subjects will be asked to swallow the tethered capsule, while they are awake~     and unsedated and ask for their feedback. Images will be taken using the OFDI system while~     the capsule travels from the esophagus into the stomach and into the duodenum.~   "
104263|NCT02202668|"~     The primary translational research objective of the study is to demonstrate feasibility of~     using the Transcutaneous Raman Spectroscopy technology in a point-of-care environment. This~     study represents an initial evaluation of the device in a small cohort of human patients with~     diabetic foot ulcers. We will be evaluating safety, device design and certain human~     engineering factors associated with point of care use of the TRS. We anticipate the data we~     collect in this study will form the basis of later medical device studies.~   "
104264|NCT02202655|"~     The purpose of this study is to investigate the changes of lymphocyte subsets in chemotherapy~     course of patients with non-small cell lung cancer~   "
104265|NCT02202642|"~     Using collagenase to isolate limbal stem cells and improve the technique of ex vivo expansion~     of limbal stem cells for the treatment of patients suffering from unilateral limbal stem cell~     insufficiency based on the concept of limbal stem cells need special cell-cell contact and~     cell-extracellular matrix interaction to support their survival.~   "
104266|NCT02202629|"~     Acute, randomized, placebo controlled, double blind, 4 arm crossover study to determine the~     effect of different combinations of plant based extracts on cognitive function and cerebral~     blood flow.~   "
104267|NCT02202616|"~     This is a single cohort, prospective post approval study conducted on patients with COPD in~     Canada. The study will enroll patients that have not responded to their current treatment of~     tiotropium alone, or who are on the fixed dose combinations fluticasone~     propionate/salmeterol. Only patients for whom the physician has decided to change treatment~     due to lack of efficacy will be eligible to be enrolled in the study.~      Also will evaluate the real-life effectiveness of QVA149 (indacaterol 110 mcg/glycopyrronium~     50 mcg) in the management of patients.~   "
104268|NCT02202603|"~     A Double blinded (oral), Open Label, Study to Assess the Safety, Pharmacokinetics and~     Pharmacodynamics of Oral PTH (1-34) in healthy Subjects to establish the safety,~     tolerability, bioavailability, pharmacokinetic, and pharmacodynamic profile and the of~     Entera's oral PTH(1 - 34) in adult healthy human volunteers.~   "
104269|NCT02202590|"~     The goal of this study is to test the feasibility and the tolerability of a tethered~     spectrally encoded confocal microscopy (SECM) capsule and to use it to image the esophagus.~   "
104270|NCT02202577|"~     Primary Hypothesis: chlorhexidine gluconate alcohol skin antiseptic preparation is superior~     to povidone-iodine scrub and paint skin antiseptic preparation for prevention of cesarean~     related surgical site infection.~   "
104271|NCT02202564|"~     HCC patients with tumors >5 cm in diameter, regardless of involvement in the intrahepatic and~     extrahepatic portal branches participated in the study. Patients were randomized allocated in~     liver transplantation (LT) only group and LT plus ADV-TK therapy group. All patients received~     orthotopic liver transplantation; in the LT plus ADV-TK group, ADV-TK therapy was delivered~     to patients twice.~   "
104272|NCT02202551|"~     This is a 105-week open-label study to evaluate the safety and tolerability of ADS-5102 oral~     capsules, an extended release formulation of amantadine, in Parkinson's Disease (PD) patients~     with Levodopa Induced Dyskinesia (LID).~   "
104273|NCT02202538|"~     This study will evaluate the Indego® device for safety and effectiveness at allowing persons~     with SCI who are non-ambulatory or poorly ambulatory to stand up and walk under a variety of~     conditions.~   "
104274|NCT02202525|"~     The main purpose of this prospective, multicentre, french observational study is to analyse~     the evolution of pulse pressure (PP) and to identify its prognostic factors in hypertensive~     patients three months after initiation of a new hypertensive therapy. The PP is defined as~     the difference between systolic blood pressure (SBP) and diastolic blood pressure (DBP).~   "
104275|NCT02202512|"~     Main objective is to investigate the measured glomerular filtration rate (mGFR) as assessed~     by iohexol clearance in healthy male normovolemic subjects after oral administration of~     single and repeated doses of BI 1060469, and BI 1021958.~      The secondary objective of this trial is to investigate the glomerular filtration rate (GFR)~     as assessed by 24 hours creatinine clearance in healthy male normovolemic subjects after oral~     administration of single and repeated doses of BI 1060469, and BI 1021958.~   "
104276|NCT02202499|"~     The purpose of this Pilot feasibility study is to find out the effect of different behavioral~     treatments along with different duration of a drug called varenicline, on smoking behavior~     and quitting smoking. Varenicline, also known as Chantix™, is an FDA-approved medication that~     has been shown to help people quit smoking.~   "
104277|NCT02202486|"~     Substudy 1 Blood-brain barrier breakdown has been proposed in migraine patients. Our~     hypothesis that we will test in this study is that the blood-brain barrier breaks down during~     migraine attacks but not out side attacks using MRI.~      Substudy 2 Altered cerebral resting-state functional connectivity networks have been reported~     in migraine patients outside migraine attacks. What happens during migraine attacks has never~     been investigated. The hypothesis we will test is that pain related networks are affected~     during spontaneous attacks using functional MRI.~      Substudy 3 Old studies report that cerebral blood flow (CBF) is altered in patients with~     migraine with aura, but not in those without aura. We hypothesize that CBF is altered~     regionally during attacks, which we will investigate in this study using arterial spin~     labeling (ASL).~      Substudy 4 Structural changes using voxel-based morphometry (VBM) of the brain have been~     suggested but never investigated during migraine attacks. Our hypothesis is that pain related~     structures show altered VBM during spontaneous migraine attacks.~   "
104280|NCT02202447|"~     The purpose of this study is to determine the safety of EC1169 and the best dose to use in~     humans in future studies. This study will also determine how EC1169 is distributed, broken~     down, passed and absorbed through your body and how quickly it is eliminated (leaves the~     body). All patients will receive EC1169.~      As a secondary objective in Part A: To explore the relationships between baseline PSMA~     expression (tumor and patient level) as measured by 99mTc-EC0652 scans and the antitumor~     activity of EC1169.~      As an exploratory objective in Part B: To assess EC0652 as a predictive biomarker for the~     efficacy of EC1169 by comparing PSMA-positive and PSMA-negative lesions for response.~   "
104281|NCT02202434|"~     The objective of this study is to evaluate the safety and effectiveness of the Lotus™ Valve~     System and LOTUS Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in~     symptomatic subjects with calcific, severe native aortic stenosis who are considered at~     extreme or high risk for surgical valve replacement.~   "
104282|NCT02202421|"~     This study is a 10-week, randomized, parallel groups design which will evaluate the efficacy~     of T-ABA with combined parent training and individual child sessions versus T-ABA with~     individual sessions alone. T-ABA refers to Targeted Applied Behavior Analysis treatment, a~     form of behavior therapy used to promote skill development and reduce disruptive behavior in~     individuals with autism. Four key outcome assessment points will be used: baseline (week 0),~     midpoint (week 5), end-of-study (week 10), and follow-up (week 20). Participants receiving~     T-ABA parent training only will be offered eight individual therapy sessions at the end of~     the study. Total study participation is estimated to be ~ 10 weeks with a single follow-up~     assessment.~   "
104283|NCT02202408|"~     In this Phase I study, the primary objective is to investigate the safety and tolerability of~     SKI2670 after oral administration in healthy female subjects. And secondary objective is to~     investigate the pharmacokinetics and pharmacodynamics of SKI2670 after oral administration in~     healthy female subjects.~   "
104284|NCT02202395|"~     The purpose of this study is to investigate the efficacy and safety of Hydroxytriptolide(LTS)~     in active rheumatoid arthritis patients with an inadequate response to methotrexate.~   "
104285|NCT02202382|"~     Objective: Several in vitro studies report positive effects of ginseng on spermatogenesis.~     However, no controlled human clinical study of the effect of Korean red ginseng (KRG) on~     spermatogenesis has been performed. This study was performed to investigate the effects of~     KRG on semen parameters in male infertility patients in a randomized, double-blind,~     placebo-controlled study. Methods: A total of 80 male infertility patients with varicocele~     were recruited from April 2011 to February 2012. The subjects were then divided into the~     following four groups: non-V + P group, placebo; V + P group, placebo and varicocelectomy;~     non-V + KRG group, 1.5-g KRG daily; V + KGR group, 1.5-g KRG daily and varicocelectomy. Semen~     analysis was performed and hormonal levels were measured in each treatment arm after 12~     weeks.~   "
104286|NCT02202369|"~     The purpose of this study is to determine if post-operative pain and rate of recovery are~     improved in patients undergoing spine surgery using MMA (multimodal analgesia) compared to~     usual analgsic care.~   "
104287|NCT02202356|"~     This study will assess the safety, tolerability, pharmacokinetics (PK) and anti-viral effect~     of single and multiple doses of ALS-008176 in infants hospitalized with respiratory syncytial~     virus (RSV)~   "
104288|NCT02202343|"~     School based Health and Nutrition Education (SHNE) is a key component of school health and~     nutrition programs that can address several health and nutrition issues in Ethiopia.~   "
104289|NCT02202330|"~     Two thirds of all strokes happen in developing countries like Pakistan. There is a serious~     lack of health literacy regarding survival after stroke. We hypothesize that our set of 5~     minute videos that teach important skills to stroke survivors and their caregivers , that can~     be replayed in cell phones for extended learning, will increase their adherence to~     Medications after stroke and improve the control of blood pressure, elevated cholesterol and~     glucose in the participants getting cell phone based educational videos.~   "
104290|NCT02202317|"~     This is a prospective non-blinded case series involving the acquisition of a pair production~     PET/CT as soon as possible after an already performed Y-90 Sirspheres treatment of hepatic~     malignancy. It will be performed in addition to the standard Brehmsstrahlung SPECT scan. The~     sequence of the two scans in each case (PET/CT vs SPECT) will be determined by availability~     of the scanners at the time. However, it is intended that both be acquired on the day of the~     Y-90 treatment.~      The length of subject participation will be one year.~      The measures used will be mostly qualitative in nature, and will include:~        -  Correlation with expected vs. achieved tumor coverage by the treatment~        -  Correlation between treatment distribution depicted by Brehmsstrahlung scans vs. the~          Internal Pair Production PET/CT scans, to.~        -  Detection of non-target embolization, where applicable, and qualitative comparison~          between the two modalities as to the conspicuity of the abnormality~      Qualitative methods will be used by the analysis of the obtained PET/CT images and comparing~     them to the Brehmsstrahlung SPECT images as previously described.~   "
104291|NCT02202304|"~     Cervitec, a chlorhexidine based varnished has been proven to reduce caries risk in younger~     populations. This study wants to investigate if the use of this product would reduce the risk~     of losing abutment teeth on patients that are wearing partial dentures as the literature has~     proven that these teeth are more prone to caries and periodontal disease.~      The primary objectives of this research project are to:~        1. Assess if the topical application of CHX/thymol varnish every three months on partial~          denture abutment teeth results in a clinicallu significant decrease in any loss of~          attachment compared to no application, and~        2. Assess if the topical application of CHX/thymol vanirhs every three months on partial~          denture abutment teeth results in a clinically significant decrease in carious lesion~          development or progression compared to no application.~      The secondary objectives of this research project are to:~      1. Assess of the topical application of CHX/thymol varnish every three months on partial~     denture abutment teeth compared to no application results in a clinically significant~     difference in:~        1. Bleeding on probing (BoP).~        2. Plaque formation.~        3. Periodontal pocket depths.~        4. Microbial composition and GCF cytokine profile of the sub gingival environment.~        5. The patients self perception of oral health.~   "
104301|NCT02202174|"~     This purpose of this study is to determine the effectiveness, risk factors, and complications~     associated with use of supraglottic airway devices for primary airway maintenance during~     routine anesthesia in children.~   "
104292|NCT02202291|"~     Vasospasm is a transient contraction causing a decrease in caliber of a vessel and thus a~     decrease in vascularization in a vascular territory leading to suffering of tissue in the~     sector concerned. Vasospasm-related diseases have different clinical presentations such as~     migraine, spastic angina, hypertension related to vasospasm or primary Raynaud's phenomenon~     (RP). These diseases have few therapeutic methods due to poorly understood pathophysiology.~     For migraine and angina, the vascular exploration is problematic unlike for primary Raynaud's~     phenomenon (RP).~      Primary Raynaud's phenomenon (RP) is a common peripheral vascular disease to cold with an~     estimated prevalence between 5-9 % of the general population. It is the expression of an~     extreme vasospasm microcirculation of the extremities linked to hypersensitivity to cold and~     that is clinically expressed by the occurrence of syncope stages where the fingers are~     anesthetized and white, followed by a stage with hyperemic restaining .~      The objective of our study is to identify new metabolic pathways involved in vasospasm in~     order to consider new specific treatments, currently lacking.~      The identification of these pathways will be made by the detection of genetic abnormalities~     causing vasospasm in Raynaud's phenomenon. This disease is a perfectly appropriate model to~     study vasospasm by its high frequency in the population, its hereditary nature and simple~     diagnosis. The powerful current genetic strategies will be applied to this model (exome~     sequencing combined to family connection analysis).~   "
104293|NCT02202278|"~     The aim of the study is to determine serum oxidative stress status by ischemia modified~     albumin (IMA), total antioxidant capacity (TAC), total oxidative capacity (TOS), oxidative~     stress capacity (OSI), and serum malondialdehyde (MDA) in patients with OHHS and control~     group. We also aim to reveal the association between serum levels of these factors and oocyte~     quality.~   "
104294|NCT02202265|"~     Background: Cardiovascular diseases are the major health problem worldwide and the~     understanding of genetic contributions on the development of cardiovascular diseases is~     increasing significantly. The CD36 is a protein associated with uptake of oxidized forms of~     LDL and the single nucleotide polymorphism (SNP) rs1761667 A/G in the CD36 gene is correlated~     with increased consumption of total fat. The transcription factor STAT3 is released during~     the inflammatory acute phase response and the SNP rs8069645 G/A in the STAT3 gene is~     associated with abdominal obesity and higher intake of saturated fat. Studies have been shown~     the benefits of the Mediterranean diet in secondary prevention of cardiovascular disease and~     these dietary patterns have been often studied with nutrigenetic approach; these studies,~     however, are often limited to European populations, making it difficult to generalize to~     different populations.~      Hypothesis: Different dietary approaches may similarly influence in modifying metabolic,~     inflammatory and anthropometric profile, especially among patients with coronary arterial~     disease (CAD). The genetic interaction with environmental factors such as the nutrient~     intake, and the prescription of a different diet according to individual genotype, could~     influence the development and/or the treatment of cardiovascular diseases.~      Objective: To evaluate the effect of three dietary approaches on metabolic, inflammatory and~     anthropometric profile in patients with CAD and possible interactions with polymorphisms in~     CD36 and STAT3 genes.~   "
104295|NCT02202252|"~     It is not known whether decreasing the number of drains used decreases patients' discomfort~     and duration of hospital stay without increasing seroma formation after mastectomies.~      Hypothesis. Use of one drain increases patient comfort without increasing seroma formation~     after modified radical mastectomy (MRM) as compared to double drains.~      Material and Method: Sixty patients undergoing MRM at Diskapi Yildirim Beyazit Training and~     Research Hospital will be randomised into single versus double drains groups. A negative~     pressure drain will be inserted below the lower flap directing to the axilla in the single~     drain group or two similar drains will be inserted into the axilla and below the lower flap~     in the double drains group. Drains will be removed if the output is less than 30 ml. Seroma~     is defined as fluid accumulation below the flaps and will be examined daily after the~     operation. One day after removal of the drains seroma under the flaps and in the axilla will~     be examined by ultrasonography. Age, body mass index smoking history, coexisting diseases of~     the patients duration of the hospital stay, duration of the drains in place, total drain~     output in the first three days after the operation and the need and frequency of aspirations~     due to seroma formation will be recorded. Patient comfort was measured with a comfort scale~     between 1-10 measuring incisional pain, pain caused by the drains, discomfort or sleep~     disturbances caused by the drains, The duration of the longer staying drain in the double~     drain group will be recorded for the duration of the drain in place parameter.~   "
104296|NCT02202239|"~     To explore the effect of induction and maintenance of anesthesia with etomidate on~     hemodynamics and oxidative stress in diabetic patients.~   "
104297|NCT02202226|"~     The purpose of this study is to evaluate the tolerability and safety of Lu AF35700 after~     repeated oral dosing to patients with schizophrenia.~   "
104298|NCT02202213|"~     The purpose of this study is to evaluate the safety and tolerability of Lu AF11167 in~     patients with schizophrenia following various repeated dosing regimens of Lu AF11167 (alone~     or as added treatment to risperidone).~   "
104299|NCT02202200|"~     An open label multicentre, phase I-II study with tumour molecular pharmacodynamics (MPD)~     evaluation and pharmacokinetics of PD-0332991 added to vemurafenib in patients suffering~     metastatic melanoma with BR.~      The main objective is to establish the Maximum Tolerated Dose (MTD) of PD-0332991 when added~     to standard vemurafenib therapy (960 mg BID). The estimated MTD is defined as the dose of~     PD-0332991 combined with vemurafenib that will be associated with a prespecified proportion~     of patients experiencing a Dose-Limiting Toxicity (DLT), ie, 1/3.~   "
104300|NCT02202187|"~     GSK2140944 belongs to the Bacterial Type II Topoisomerase Inhibitor (BTI) class of~     antibiotics. GSK2140944 has demonstrated in vitro and in vivo activity against Gram positive~     including methicillin resistant Staphylococcus aureus (MRSA) and Gram-negative pathogens~     associated with respiratory tract, skin and soft tissue infections including isolates~     resistant to existing classes of antimicrobials. This is a First Time in Human (FTIH) study~     to assess the safety, tolerability, and pharmacokinetics of single oral doses of GSK2140944~     in healthy volunteers. This study will be a single-blind, randomized, placebo-controlled,~     dose-rising study in healthy subjects. The proposed single doses will range from 100 mg to~     3000 mg.~   "
119980|NCT01997086|"~     The purpose of this study is to evaluate the effectiveness of two minimal invasive endoscopic~     discectomy, PTED and MED, for the treatment of symptomatic lumbar disc herniation.~   "
104302|NCT02202161|"~     This study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and~     pharmacodynamics of GSK2330672 compared to sitagliptin when administered with metformin for~     14 days to subjects with type 2 diabetes mellitus (T2DM). Approximately 72 male and female~     subjects aged 30-64 years with T2DM and currently taking metformin will be recruited for this~     study. Eligible subjects will begin a run-in period of 13-15 days to stabilize on metformin~     850 milligram (mg) twice a day (BID). Subjects will then be randomized to GSK2330672 10 mg,~     20 mg, 30 mg, 90 mg, matching placebo or open-label sitagliptin 50 mg for 14 days BID.~     Subjects will return for a follow-up visit 7-10 days after discharge.~   "
104303|NCT02202148|"~     This study is complementary to the main study Brain Derived Neurotrophic Factor Serum Levels~     Evolution During the Six Months After Alcohol Withdrawal  NCT01491347.~      Liver stiffness variation is one of the major somatic effect of chronic alcohol consumption.~     It is a consequence of numerous mechanisms, including inflammation. Liver stiffness seems to~     depend on alcohol consumption in alcohol dependent patient, more precisely on the time after~     the last alcohol consumption. This is very few documented after alcohol withdrawal, and has~     never been explored during several months after withdrawal as a function of alcohol~     consumption and abstinence.~      Brain Derived neurotrophic Factor (BDNF) seems to play a major role in general homeostasis~     and also liver function.~      We propose here to analyse the serum BDNF levels variations after withdrawal according to~     liver stiffness levels and alcohol consumption status.~      We will also measure liver stiffness using Fibroscan® in alcohol dependent subjects included~     in the main study to search for a link with serum BDNF levels and abstinence at day 0, 14, 28~     and months 2, 4, and 6.~   "
104304|NCT02202135|"~     The purpose of this study is to evaluate the effects of Ceftaroline Fosamil versus Vancomycin~     plus Aztreonam in treatment of patients with complicated bacterial skin and soft tissue~     infections.~   "
104305|NCT02202122|"~     Interest of the four major OSA Predictive Scores (STOP-BANG, P-SAP, DES-OSA, OSA50) in the~     prognosis of postoperative mortality after femoral neck fracture.~   "
104306|NCT02202109|"~     The study will test the significance of community health worker (CHW) participation by~     comparing self-sampling provided by a community health worker and self-sampling provided by~     mail. The study will enroll 700 participants in communities that lack access to medical care~     in South Florida.~   "
104307|NCT02202096|"~     The primary hypothesis is that a comprehensive transitional care program based on the premise~     of a patient-centered medical home versus routine care reduces emergency room visits and~     hospital readmissions without increasing costs among cancer patients undergoing surgery at a~     large safety-net hospital.~   "
104308|NCT02202083|"~     Currently, the study about intervention on the induced abortion at trimester is so little.~     So, the investigators want to compare the safety and effectiveness of different induced~     labor.~   "
104309|NCT02202070|"~     Hypothesis: Myofascial temporomandibular joint disorder and related symptoms are associated~     with mandibular condyle and temporal fossa overloading secondary to temporalis and masseter~     muscle hyperactivity and spasm~      This study will examine the use of onabotulinumtoxinA (Botox) to treat myofascial pain~     disorder in patients with bruxism who frequently exhibit signs of temporomandibular joint~     disorder (TMD) in a double blind cross-over randomized clinical trial by injecting 50 units~     Botox in temporalis and masseter muscles in 32 patients with 6 months follow up.~      The objective of the proposed study will be to establish the safety and efficacy of botox in~     treating TMD associated with bruxism. By the time patients reach the specialists office, most~     have failed maximal conservative therapies, including non-chew diet, night guard, oral~     analgesics, muscle relaxants, physical therapy, and a portion have even undergone more~     invasive procedures, such as manipulation under anesthesia, arthroscopy, and arthroplasty~     surgeries with limited improvement or recurrence. Primary outcome of the study will be 50%~     reduction in pain. Secondary outcomes will be 50% reduction in surgical therapy, 25% increase~     in maximal inter-incisal opening (MIO). The investigators look forward to working with you on~     the proposed study~   "
104310|NCT02202057|"~     The purpose of this study is to determine whether people with Parkinson's disease (PD)~     experience reduced perception of respiratory resistive loads versus healthy adults in the~     same age group. Further, the study will determine whether people with PD and trouble~     swallowing experience even more reduction of their perception of a respiratory resistive~     load.~   "
104311|NCT02202044|"~     The primary objective of the study is to assess the bladder cancer recurrence free rate,~     according to a phase II pilot study, of intravesical instillation of sequential BCG and~     EMDA/MMC after TUR. The study is designed as a one-sample investigation: the outcome measure~     is disease recurrence rate. Follow up will continue up to 5 years.~      For sample size determination, disease recurrence rate will be compared with literature data~     of recurrence rate obtained in standard BCG alone administration (Lamm's protocol).~   "
104312|NCT02202031|"~     We propose to conduct a rigorous, 12-week, randomized controlled trial of two relaxation~     therapies in 160 ambulatory women who report an average of at least 3 urgency-associated~     voiding or incontinence episodes per day. Participants will be randomized in a 1:1 ratio to:~     1) practice slowing their resting respiratory rate to 5 to 10 breaths per minute for at least~     15 minutes/day at home using a portable guided-breathing device; or 2) use an~     identical-appearing device that plays relaxing music while monitoring their spontaneous~     breathing pattern. We do not know if either of the two types of relaxation therapies is~     effective in treating OAB. All women will also receive a usual care pamphlet providing basic~     information about other traditional self-management strategies for OAB.~   "
104313|NCT02202018|"~     Patients with severe kidney failure require dialysis or transplantation to survive. For those~     in whom a transplant is not an option, there are two main dialysis options: hemodialysis~     (either incenter or at home) or home peritoneal dialysis. Home-based therapies (peritoneal~     and home hemodialysis) are under-utilized in many Canadian jurisdictions with the proportion~     of home-based therapies varying between 10 and 40% across centres. Studies show that the low~     use of home dialysis is due to a variety of factors, though patient and provider awareness~     and knowledge of home dialysis are major factors. In this cluster randomized trial, the~     investigators will determine whether a standardized modality education program directed at~     patients, in combination with a provider-directed intervention, can increase the use of home~     dialysis in incident dialysis patients in Canada.~   "
104315|NCT02201992|"~     This randomized phase III trial studies how well crizotinib works in treating patients with~     stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation~     in a protein called anaplastic lymphoma kinase (ALK). Mutations, or changes, in ALK can make~     it very active and important for tumor cell growth and progression. Crizotinib may stop the~     growth of tumor cells by blocking the ALK protein from working. Crizotinib may be an~     effective treatment for patients with non-small cell lung cancer and an ALK fusion mutation.~   "
104316|NCT02201979|"~     Breast lift surgery performed in combination with breast implants is a common cosmetic~     operation. However, there have been concerns regarding the safety of this treatment~     combination. Some investigators are concerned that an implant may increase the risk of~     complications, including loss of circulation to the nipple and areola. This study was~     undertaken to evaluate the blood supply of the breast using intraoperative laser fluorescent~     imaging and to determine whether a breast implant compromises blood supply to the nipple and~     areola.~   "
104317|NCT02201966|"~     Low back pain is a common condition in children who perform gymnastics. Commonly, the injury~     is not the result of a specific injury, but is a stress injury to the lumbar spine. Regional~     interdependence is a theory that suggests when adjacent joints and muscles are not working~     properly increased stress is placed on a particular joint. This theory would suggest that if~     a patient did not have enough hip extension to perform a back bend increased motion would~     occur in the lumbar spine allowing the gymnast to complete the technique. Currently, no~     research links impairments in other joints to low back pain in gymnasts.~      This is a cross sectional study assessing the relationship between gymnast with back pain and~     flexibility and strength of the shoulder and hip joints. Investigators will travel to a local~     gymnastics training centers and assess the gymnasts' strength and flexibility of the the hips~     and shoulders. The gymnast will also fill our a questionnaire assessing if they have had back~     pain in the past month and how much has it limited their ability to participate in~     gymnastics. Investigators will be blinded to the results of this survey.~      The goal of this research study is to see if there are any link between strength and~     flexibility of the hips, and shoulders and gymnasts with low back pain. The investigators~     hypothesize that gymnasts who demonstrates impairments in strength and flexibility of the~     hips, or shoulders will be more likely to have complaints of low back pain.~   "
104318|NCT02201953|"~     The primary objectives of this study are to compare the efficacy of treatment with~     sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks with that of~     sofosbuvir (SOF) + ribavirin (RBV) for 24 weeks and to evaluate the safety and tolerability~     of each treatment regimen in participants with chronic genotype 3 hepatitis C virus (HCV)~     infection.~   "
104319|NCT02201940|"~     The primary objectives of this study are to evaluate the efficacy, safety, and tolerability~     of sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) for 12 weeks in adults with~     chronic genotype 1, 2, 4, 5, or 6 hepatitis C virus (HCV) infection.~   "
104320|NCT02201927|"~     Right posterior parietal cortex is involved in spatial cognition. Blindfolded patients~     suffering right posterior parietal lesions fail to update their own position after a body~     rotation. Right cathodal galvanic vestibular stimulation activates right posterior parietal~     cortex and reduces symptoms of spatial neglect, another disability frequently encountered~     after right posterior parietal lesion. The aims of this study are to confirm posterior~     parietal involvement in automatic updating of body-centered spatial relationships and to~     evaluate therapeutic effects of galvanic vestibular stimulation. Performances of three groups~     of adults are compared before and during galvanic vestibular stimulation on a pointing task:~     a healthy control group, a brain-injured control group with stroke lesions sparing right~     posterior parietal cortex and a group of stroke patients with right posterior parietal~     lesions.~   "
104321|NCT02201914|"~     Poor ovarian response to stimulation in IVF cycles is a challenging and frustrating~     condition, due to its poor prognosis in terms of chances of pregnancy and live births.~     Various ovarian stimulation regimens have been tried to overcome these obstacles. A simple~     approach is increase the dose of the gonadotropin administration, but the results in terms of~     pregnancy rate are very low Another commonly used stimulation regimen is the microdose GnRH~     agonist protocol, which takes advantage of the initial rise in endogenous gonadotropins that~     follows the agonist administration in the early follicular phase and subsequently prevents a~     premature LH surge, with fewer cycle cancellations. However, their application in poor~     responders, even if in small doses and for a limited period, has been questioned as they may~     cause oversuppression of ovarian function, leading to a prolonged cycle and increased~     treatment costs without improving the outcomes.~      Recently, GnRH antagonists were introduced in ART treatment. They are effective in preventing~     a premature LH surge and allow for a more natural recruitment of follicles in the follicular~     phase in a non-suppressed ovary, offering a potential alternative in the treatment of these~     patients. However, randomized studies evaluating the efficacy of this regimen in poor~     responders did not show any improvements in pregnancy rates. Current approach have included~     the addition of oral agents such us clomiphene citrate (CC) to gonadotropins. Some authors~     have investigated the role of CC in addition to low dose of gonadotropins in mild stimulation~     regimen, demonstrating that, despite a small number of retrieved oocytes, good quality~     embryos were produced with a subsequent improvement in the fertilization rate, clinical~     pregnancy rate and live birth rate. The only study that evaluate the efficacy of CC in~     addition to high doses of gonadotropins in poor responders showed improving in number of~     retrieved oocytes, transferred embryos and biochemical pregnancy; however, clinical pregnancy~     rate and live birth rate remained low and showed no measurable increase.~      The aim of this study was to compare the efficacy of the CC as an adjunctive to a high dose~     of gonadotropins in cycles with antagonist protocols with the microdose GnRH agonist and~     flexible antagonist protocols in women who responded poorly to ovarian stimulation, to~     determine whether this protocol may improve IVF outcomes, offering a valid alternative in~     poor responder patients treatment.~   "
104322|NCT02201901|"~     The primary objectives of this study are to evaluate the efficacy, safety, and tolerability~     of sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) with and without ribavirin~     (RBV) for 12 weeks and SOF/VEL FDC for 24 weeks in adults with chronic hepatitis C virus~     (HCV) infection and Child-Pugh-Turcotte (CPT) class B cirrhosis.~   "
104343|NCT02201615|"~     Objective To examine the effects of perineal massage applied during the action of birth on~     the frequency of episiotomy procedures, perineal tearing and the duration of the second stage~     of birth.~      Methods The present study was a randomized controlled experimental. Women (284 women) were~     informed on the study and provided their written consent. 10-minute perineal massage with~     glycerine was applied to the women in the test group for 4 times during the first stage and 1~     time in the second stage of birth. The women in the control group received the routine care~     procedure at the clinic.~      Results According to the study findings, 31% of the women in the test group and 69.7% of the~     women in the control group were made subject to episiotomy (p<0.05). In the test and control~     group 9.2%, 2.4% of the women developed spontaneous perineal laceration (p>0.05). The average~     duration of the action of birth was 25.33 minutes in the test group and 28.18 minutes in the~     control group (p<0.05).~      Conclusion The study results indicate that perineal massage applied during the action of~     birth decreased the rate of episiotomy procedure and shortened the duration of the second~     stage of birth.~   "
104323|NCT02201888|"~     Schizophrenia is known to be associated with cognitive dysfunction which increasing evidence~     suggests has consequences for functional adaptation and which cause difficulties in social~     re-integration after hospitalization. The investigators propose a large scale, multicentric~     study (7 centres from the Hermanas Hospitalarias del Sagrado Corazón de Jesús network) aimed~     at answering outstanding questions concerning the effectiveness of cognitive estimulation~     therapy for schizophrenic cognitive impairment. Specifically, the study will examine a)~     issues related to the size of the effect compared to treatment as usual and compared to a~     control intervention; b) generalizability of improvement to cognitive function and social~     cognition in daily life; and c) the durability of therapeutic gains after the end of~     treatment. 192 patients with chronic schizophrenia will be randomly assigned to one of three~     treatment conditions: a computer- assisted cognitive estimulation program (n=64),~     non-structured time on computer (n=64) and treatment as usual (n=64). A battery of~     neurocognitive tests of memory and executive function, including 'ecologically valid'~     measures, will be administered by blind evaluators at baseline, after 6 months of cognitive~     estimulation, and after 6 months follow-up. Symptoms, social functioning and self-esteem will~     be also be assessed at baseline, after the treatment and at follow-up.~   "
104324|NCT02201875|"~     We made a fortuitous observation of periodic breathing in a healthy subject coming to our~     outpatient mountain medicine consultation at Avicenne hospital in Bobigny (France). During~     this consultation, subjects perform a hypoxia exercise test, which allows a good prediction~     of their risk factors for severe high altitude illnesses. Surprisingly, breath-by-breath~     recording of the ventilation signal showed a periodic breathing pattern, which increased when~     the subject started to exercise in hypoxic conditions and was maintained during normoxic~     exercise.~      Therefore, our objective was to confirm this observation in a retrospective study led in 82~     subjects who passed this test. We tested the hypothesis that subjects with a brisk~     ventilatory response to hypoxia might show a more pronounced periodic pattern of ventilation,~     due to a higher gain of the chemoreceptor feedback loop. Then, our objective is to~     investigate the mechanisms involved in the periodic pattern in healthy subjects, as a~     function of exercise intensity, altitude intensity, role of peripheral and central~     chemoreceptors to O2 and CO2. Finally, we want to investigate the possible role of this~     ventilatory instability in patients with obstructive or central apneas.~   "
104325|NCT02201862|"~     This study is being conducted to provide clinically annotated samples to support continued~     improvements in the Ariosa Test content, methodology, specimen processing and quality~     control.~   "
104326|NCT02201849|"~     This study will evaluate the safety, tolerability, and pharmacokinetics of ALKS 8700, a~     monomethyl fumerate (MMF) molecule.~   "
104327|NCT02201836|"~     The onset of asthma is particularly frightening for children. When the symptoms of asthma~     decrease, children and parents forget about the maintenance and control of breath and lung~     volume. Because adherence is so poor, asthma is known as the emergency room illness. The~     playing of a wind instrument is a unique way to provide a creative means for children and~     teens to understand both the impact of diaphramatic breathing and their ability to control it~     as well. This study builds upon the evidence, though sparse, that suggest that the blowing of~     a wind instrument with clinical music therapy intervention strengthens the muscles of~     breathing and fortifies the incentive toward attending to the daily symptoms and general~     management of asthma.~   "
104328|NCT02201823|"~     Ability Pharmaceuticals promotes a clinical trial to determine the adequate dose of a new~     drug, ABTL0812, that will be administered orally daily to patients with advanced solid~     tumors.~   "
104329|NCT02201810|"~     This study is a randomized clinical trial designed to measure the effectiveness of three QL~     interventions for smokers who failed to quit an initial smoking cessation intervention, but~     remain motivated to quit smoking.~   "
104330|NCT02201797|"~     Advanced MRI (Magnetic Resonance Imaging) technique called DCE (Dynamic Contrast Enhanced)~     and DWI MRI can provide valuable information regarding tumor biology and response to~     treatment through various parameters. Validating stability of these parameters will further~     establish robustness and reliability of these promising biomarkers.~   "
104331|NCT02201784|"~     The purpose of this study is to compare the effects of two intrathecally administered~     drugs:0.5% levobupivacaine and0.75%Ropivacaine in spinal anesthesia~   "
104332|NCT02201771|"~     The study population will include all patients undergoing elective CABG. Consent and~     randomization will occur before surgery. Total 500 patients undergoing elective CABG will be~     randomly assigned into three groups with 1:1:1 ratio(167 patients per group) in this~     open-label study. All the enrolled patients will stop oral antiplatelet drugs according to~     local protocol before the surgery. Within the first 24 hours after surgery, study medication~     should be restarted and continued for 12 months. Arm A will restart oral antiplatelet drugs~     by giving aspirin 100mg qd, Arm B will also restart oral antiplatelet drugs by giving~     ticagrelor 90mg bid plus aspirin 100mg qd and Arm C will also restart oral antiplatelet drugs~     by giving ticagrelor 90mg bid. Treatment will continue for 12 months, at which time patients~     will undergo a multislice computed tomography angiography to assess vein graft patency.~      This study is designed to show the superiority of ticagrelor and ticagrelor plus aspirin as~     compared with aspirin monotherapy respectively for the 1-year primary efficacy end point of~     vein graft patency.~   "
104333|NCT02201758|"~     This study proposes to examine the effect of diet as a modifiable risk factor among patients~     with ulcerative colitis (UC). Flax seeds contain many bioactive constituents which have~     anti-oxidative, anti-inflammatory, and anti-carcinogenic effects. These bioactive compounds~     represent novel classes of pharmacologically active compounds which may represent new options~     to treat chronic disease of the gastrointestinal tract. Participants with mild to moderately~     severe UC will supplement their current medications with flaxseed lignan-enriched complex~     (FLC). This is a 12 week double blind placebo controlled study with assessment throughout.~     Stool and blood samples (biomarkers) as well as bowel assessment via sigmoidoscopy will be~     evaluated before and after the intervention. The treatment arm consists of 300 mg FLC taken~     orally twice daily.~   "
104334|NCT02201732|"~     The purpose of this study of is to compare subsequent fertility rates between hysteroscopy~     and aspirative curettage in the surgical treatment of incomplete spontaneous abortion~   "
104344|NCT02201602|"~     Gliclazide has greater glucose lowering efficacy than glibenclamide among type 2 diabetes~     mellitus patients with minor haplotype (K23/A1369) at the KCNJ11/ABCC gene locations.~   "
104335|NCT02201719|"~     Adenomyosis is characterized by the appearance of endometrial cells in the muscular layer of~     the uterus. It affects about 15-20% of the female population.~      The symptoms of adenomyosis are heavy menstrual bleedings and painful menstruation~     (dysmenorrhea) and in addition chronic pelvic pain. Subfertility and infertility have been~     correlated with adenomyosis.~      Parity, age and uterine abrasion increase the risk of adenomyosis. Hormonal factors such as~     local hyperestrogenism and elevated levels of prolactin have been identified, but autoimmune~     and mechanical factors are also hypothesized.~      Regarding treatment, the most effective measure is hysterectomy. As this is a very drastic~     measure in younger women, levonogestrel-releasing intrauterine devices, Gonadotropin~     releasing hormone (GnRH)-analogues, Danazol, uterine embolization and endometrial ablation~     have been tried, but studies are few in number, retrospective, and have small sample sizes.~      Adenomyosis has so far not been subject to extensive research efforts. The pathogenesis of~     adenomyosis remains still unclear, there are not many satisfying treatment options and~     diagnostics include mostly magnetic resonance imaging (MRI) and histology.~      The investigators designed a series of 3 studies with a broad approach in understanding~     adenomyosis. This is part 1.~      NAPPED-1: comparison of 3D-transvaginal ultrasound with MRI and histology in the diagnostic~     of adenomyosis~   "
104336|NCT02201706|"~     Retinal re-detachment in silicone oil filled eye, especially in the traumatic eye, is a~     complex retinal detachment with poor prognosis.~      In this study, the investigators try to apply a modified surgery as Multi-electrocoagulation~     retinectomy to reattach the retina. Here the investigators aimed to explore the safety and~     efficacy of this new surgical approach~   "
104337|NCT02201693|"~     The purpose of this study is to compare the rate of first relapse at 12 months between~     maintenance therapy with cyclic exclusive enteral nutrition (EEN) (at least 100% daily~     calories) and maintenance therapy with supplementary enteral nutritional support (25% daily~     calories).~   "
104338|NCT02201680|"~     1. Appreciation of preoperative anxiety in children is important for the anesthesiologist.~        2. Several factors defined to effect the anxiety levels preoperatively in children such as~          , age, previous medical encounters , education level and parental anxiety. 3. This~          information was tested for Turkish children during the preoperative anesthetic~          evaluation.~   "
104339|NCT02201667|"~     The goal of acute coronary syndrome (ACS) therapy is to successfully restore both epicardial~     blood flow and myocardial perfusion. Percutaneous coronary intervention (PCI) has been~     documented as being the most effective method for restoration of epicardial blood flow.~     However, epicardial blood flow does not necessarily equate to myocardial perfusion.~     Clopidogrel binds irreversibly to platelet P 2 Y 12 receptors to inhibit platelet~     aggregation, with main limitations of slow onset, prevention of recovery of platelet~     functions, and interindividual variability. Clinical pharmacology and early dose-finding~     studies suggested a faster onset and greater and more consistent inhibition of platelet~     aggregation (IPA) with ticagrelor compared with clopidogrel. Two currently main methods of~     angiographic assessment of myocardial perfusion includes thrombolysis in myocardial~     infarction(TIMI) myocardial perfusion grading (TMPG) and myocardial blush grading (MBG).~     These established myocardial perfusion parameters have been widely used in various important~     trials and are reported to be highly useful in predicting clinical outcomes. However, visual~     assessment of these methods is categorical, subjective, and operator dependent of contrast in~     the myocardium using cine-angiographic frame-counting, was developed by the investigators'~     center to quantify myocardial tissue- level perfusion and was proved to be a predictive value~     on clinical prognosis.~      Thus, the investigators aim to initiate an open-label study evaluating the acute efficacy of~     treatment with ticagrelor versus clopidogrel on myocardial tissue-level perfusion assessed by~     Myocardial Perfusion Frame Count(TMPFC) and magnetic resonance imaging (MRI) in patients with~     high-risk non-ST elevation acute coronary syndrome (NSTE-ACS) undergoing early percutaneous~     coronary intervention (PCI) .~      The investigators hypothesize that compared with clopidogrel, ticagrelor can significantly~     improve myocardial perfusion assessed by Myocardial Perfusion Frame Count(TMPFC) in high-risk~     non-ST elevation acute coronary syndrome (NSTE-ACS) patients undergoing early percutaneous~     coronary intervention (PCI), without additional increased major bleeding.~   "
104340|NCT02201654|"~     This research study compares two ways to biopsy lymph nodes in the chest using endobronchial~     ultrasound-guided transbronchial needle aspiration (EBUS-TNBA). During a EBUS-TBNA~     procedure, the patient is sedated, and a flexible camera and ultrasound probe is inserted~     through the mouth into the large airways of the chest, allowing us to see (via ultrasound)~     and biopsy the lymph nodes in the chest.~      The purpose of this research study is to determine if the EBUS-TBNA procedure can be made~     simpler. In today's practice, the biopsy needle has two parts, 1) the needle itself and 2) an~     inner stylet that runs through the middle of the needle. Because many other biopsy needles~     (such as the needles used in breast biopsy and different types of lung biopsy needles) do not~     use an inner stylet, the investigators do not think the use of a stylet is necessary. If this~     step can be safely eliminated without decreasing the effectiveness of the procedure, this~     could shorten the procedure (saving time). This study is deigned to formally test the~     hypothesis that a stylet is not necessary in EBUS-TBNA.~   "
104341|NCT02201641|"~     This study aims to investigate the tooth nerve response to a recently introduced therapeutic~     filling material (calcium silicate cement) called Biodentine and to assess the quality of the~     overlying filling compared to another material (glass ionomer cement) called Fuji IX used~     more commonly. Also to compare the effectiveness of cone beam computed tomography x-rays~     compared to conventional periapical x-rays in detecting lesions around these teeth.~   "
104342|NCT02201628|"~     Children lose heat under general anaesthesia, thus temperature is routinely monitored during~     anaesthesia for all but the shortest cases, and active warming can be used to prevent~     hypothermia and its resulting complications. Temperature can be measured at several sites~     dependent on the type of surgery and patient factors. Previously a temperature probe has been~     sited in the lower third of the oesophagus (swallowing tube) but it is difficult to~     accurately place this without an X-Ray. Consequently it is more common to use a temperature~     probe placed in the nasopharynx (where the nose and throat meet), when the child is~     anaesthetised.~      However the investigators do not know if the temperature in the nasopharynx correlates well~     with the real core temperature or not.This prospective, unblinded, agreement study will seek~     to find an agreement of 2 methods to measure temperature in children undergoing general~     anaesthesia with a breathing tube that has a leak.~   "
104368|NCT02201290|"~     This is an open-label Phase III extension study to evaluate the long-term safety of~     eltrombopag in pediatric patients with chronic ITP who previously participated in study~     TRA115450. This study will allow dosing of eltrombopag at an individualized dose for each~     subject based upon platelet count. The starting dose will be based on the subject's dose at~     the end of the TRA115450 study. The maximum dose will be 75 mg daily.~   "
104414|NCT02200692|"~     Allergic transfusion reactions are a common complication of transfusion by blood components~     containing plasma. This study aims to investigate passive transfer of Immunoglobin E~     antibodies as a risk factor of allergic reactions to plasma transfusion by use of Solvent~     Detergent plasma.~   "
104345|NCT02201589|"~     The purpose of this study is to investigate the outcome of patients with pathologies of the~     ascending thoracic aorta (diseases in the great blood vessel or artery that leads away from~     the heart) including type A aortic dissection, retrograde type A aortic dissection,~     intramural hematoma, penetrating ulcer or pseudoaneurysm who are suitable for endovascular~     (within the vessel) repair with the Medtronic Valiant PS-IDE (Physician~     Sponsored-Investigational Device Exemption) Stent Graft. Type A aortic dissection is a~     condition where blood passes through the inner lining or between the layers of the blood~     vessel from a tear in the aortic wall (dissection) in the ascending aorta; a retrograde Type~     A aortic dissection is a condition where the dissection or tear in the ascending aorta starts~     from the descending aorta; an intramural hematoma is a collection of clotted blood within the~     aortic wall; a penetrating ulcer has a plaque or clot within the wall and a pseudoaneurysm is~     a false aneurysm . If left untreated in any of these conditions, the aorta can enlarge and~     rupture causing injury or death. The plan for these patients is to repair the ascending~     thoracic aorta using the Medtronic Valiant PS-IDE Stent Graft with the Captivia Delivery~     System. The Valiant Captivia has been evaluated worldwide and used extensively in patients~     with type B (descending) thoracic aortic dissection. Since the dissections in the ascending~     aortas mirror that of the descending aorta, it is expected that this stent graft will deliver~     similar performance and endurance in patients with type A aortic dissection. The~     investigators expect to reroute the blood to the true lumen (the inner space within the blood~     vessel) by covering the proximal (nearest to the heart) tear with the stent graft. The stent~     graft is a stent frame made from Nitinol wire and covered with an expandable material made of~     a polyester material. This new study will determine how well the device works to treat~     dissections, intramural hematomas, penetrating ulcers and pseudoaneurysms in the ascending~     thoracic aorta.~   "
104346|NCT02201576|"~     The purpose of the study is to assess the efficacy of bortezomib, in association with~     steroids, plasma exchange, and polyclonal intravenous immunoglobulins, in the treatment of~     chronic antibody mediated rejection due to donor specific anti-HLA antibodies, in kidney~     transplant recipients~   "
104347|NCT02201563|"~     Stereotactic radiosurgery (SRS) is a well-established treatment for patients with metastatic~     brain tumors. Although SRS has a very high tumor growth control these interventions are~     associated with adverse radiation effects (ARE) in approximately 15 % of patients. The~     traditional approach, and still a mainstay, is the administration of a course of high dose~     anti-inflammatory corticosteroids. Currently there are no other effective oral~     neuroprotective agents in clinical practice which can improve outcomes of patients with ARE~     after radiosurgery for brain metastases.~      Minocycline, an antibiotic with a favorable adverse effect profile and pharmacokinetics, has~     been shown to have neuroprotective properties in experimental models of a variety of~     neurological diseases, as well as in human clinical trials. The investigators propose a~     single arm clinical trial, to evaluate the safety and feasibility of minocycline in improving~     ARE. This study will recruit 15 patients who will be treated with minocycline (100mg BID) for~     3 months. This clinical trial has the potential to prove that minocycline therapy is safe in~     this patient population. In addition, positive results will provide preliminary evidence for~     its use in an array of radiosurgical indications.~   "
104348|NCT02201550|"~     The purpose of this study is to determine the effect of exogenous glucagon-like peptide-1 on~     the immune system i.e on the regulation of immune cells important in diseases such as obesity~     and diabetes.~      The hypotheses are:~        -  Glucagon-like peptide-1 has an immunological effect observed by studying immune cells in~          the blood~        -  Treatment with glucagon-like peptide-1 increases the number of immune cells in the blood~        -  Treatment with glucagon-like peptide-1 leads to a more anti-inflammatory cytokine~          profile in the blood~   "
104349|NCT02201537|"~     The hypothesis of our study is that a correlation exists between the couple ultrasound~     elastography- renal perfusion estimated with contrast-enhanced ultrasound and the degree of~     fibrosis estimated in a semi-quantitative way in 4 stages (0; 25 %; 25-50 %; > 50 %), as~     elastography alone did not allow to differentiate moderated fibrosis at 3 months in our~     feasibility study.~   "
104350|NCT02201524|"~     Study B7451005 is a Phase 2 study which will assess the efficacy and safety of PF-04965842 in~     patients with moderate to severe psoriasis. The study will include three PF-04965842 groups~     (200 mg daily, 400 mg daily and 200 mg twice daily) and a placebo group. The treatment period~     will be 4 weeks in duration and will be followed up by a 4 week follow up period.~   "
104351|NCT02201511|"~     The study is designed to understand the blood concetration of PF-06412562 and its metabolite,~     PF-06663872, following a single oral dose of a modified release formulation. The study will~     include two doses of the PF-06412562 modified release formulation to understand the~     proportionality. Effect of food on absorption of PF-06412562 from the modified release~     formulation will also be investigated in this study.~   "
104352|NCT02201498|"~     This is a RCT that will compare the clinical and radiographic success of pulpotomies on~     primary molars between the traditional technique (Formocresol/ZOE) and the new technique with~     Biodentine. 180 pulpotomies (90 in each group) will be followed for a period of 12 months.~   "
104353|NCT02201485|"~     Budd-Chiari syndrome (BCS) is defined as the hepatic outflow obstruction from the small~     hepatic veins to the confluence between inferior vena cava and right atrium, which often~     leads to the life-threatening complications, such as liver failure and portal~     hypertension-related complications. At present, a stepwise treatment strategy is employed,~     including anticoagulation, thrombolysis, percutaneous recanalization (i.e., percutaneous~     transluminal angioplasty [PTA] alone or in combination with stent placement), transjugular~     intrahepatic portosystemic shunt, and liver transplantation. In West, only less than 20% of~     BCS patients underwent percutaneous recanalization; by contrast, percutaneous recanalization~     is the most common treatment modality used in China.~      Recently, an 11-year retrospective case series of 177 Chinese patients with primary BCS has~     shown a higher rate of re-occlusion in the PTA alone group than in the PTA combined with~     stent placement group (31% versus 7.7%, p<0.001). In addition, re-occlusion was regarded as~     the independent predictor of mortality. Accordingly, we hypothesized that PTA alone might~     have a worse survival than PTA combined with stent placement in Chinese patients with primary~     BCS.~   "
104354|NCT02201472|"~     MRI & MRE in infants~   "
104355|NCT02201459|"~     This is a phase III trial comparing, for newly diagnosed chronic phase CML patients,~     nilotinib 600 mg BID as a standard arm and nilotinib 600 mg BID combined to interferon alfa 2~     a (pegylated form improving tolerance and maybe enhancing is efficacy) at increased doses for~     a total of 24 months of combination, in a 1:1 randomized manner. The assessment for the~     primary efficacy endpoint will be performed at 12 months (since nilotinib initiation) and is~     the rate patients obtaining MR4.5 will be measured at this time point.~   "
104356|NCT02201446|"~     Efforts to identify circulating factors that predict severity of acute lung injury/acute~     respiratory distress syndrome（ALI/ARDS） patients is unrevealing. The primary purpose of this~     study is to verify our hypothesis that soluble CD74 might be a potential novel ALI/ARDS~     biomarker.~   "
104357|NCT02201433|"~     Breastfeeding is recommended for preterm infants. Development of breastfeeding is an~     important issue, requiring the involvement of medical and paramedical staff in neonatal~     units. There are few data concerning the fathers of preterm infants. However, the role of the~     father is identified in the literature as a key factor in the initiation and continuation of~     breastfeeding. In our neonatal unit care, reasons for breastfeeding high rates are not~     identified but may be related to the father being in close and constant contact with the~     medical and paramedical staff. In fact, fathers are often first in contact with caregivers.~     They can be invested in the implementation of nursing care, skin to skin, as well as being~     asked to support the development of their child in the service and at home.~      The aims of this study are to:~        -  Analyze the beliefs, social representations and the experience of the fathers of~          premature infants hospitalized in intensive care unit concerning breastfeeding.~        -  Analyze the factors facilitating and inhibiting the initiation and continuation of~          breastfeeding.~        -  Consider strategies of care and support that can be used for the families of premature~          infants and of children born at term.~        -  Explore the expectations of medical staff with regards to the management of children and~          families, their practices, identify the role attributed to the father.~        -  Initiate and facilitate reflexivity of medical and paramedical staff about their~          respective practices~   "
104358|NCT02201420|"~     The purpose of this study (NAV3-12) is to determine the dissemination and localization of Tc~     99m tilmanocept by SPECT and SPECT/CT imaging in subjects with confirmed cutaneous KS. This~     is a single center, open-label, within-subject study.~   "
104359|NCT02201407|"~     This open--label, multicenter, national observational study will investigate the~     effectiveness of standard of care treatment with peginterferon alfa-2a in participants with~     chronic hepatitis B (CHB). Participants who have never received any hepatitis B virus (HBV)~     treatment and participants previously treated with nucleos(t)ide analogs (NAs) are qualified~     for enrollment. The observation period is 48 weeks (peginterferon alfa--2a standard of care~     treatment) and for up to 24 weeks thereafter (72 weeks in total).~   "
104360|NCT02201394|"~     Acute coronary syndrome (ACS) patients treated with antiplatelet drugs who require coronary~     artery bypass grafting (CABG) surgery have to wait 5-7 days for the effects of the drugs to~     wean off. This treatment-devoid period leaves the patient vulnerable, therefore any means to~     shorten this period could be useful. The present study aims to investigate the possibility of~     reversing the antiplatelet effects of ticagrelor with the help of fresh donor platelets.~     Fresh platelets will be added to blood samples of treated patients in varying concentrations~     at specific timepoints to determine the time and amount of fresh platelets needed to~     normalize platelet reactivity in the treated samples.~   "
104361|NCT02201381|"~     The purpose of this study is to determine the effectiveness of a regimen of selected~     metabolic treatments for patients with cancer in a real world setting and to conduct~     exploratory analysis on the relationship between the degree of response and changes in~     biochemical markers (such as glucose and lipid levels).~   "
104362|NCT02201368|"~     The purpose of this study is to determine if administration Triheptanoin is an effective~     treatment for defects of the long-chain fatty acid beta-oxidation in young adults or adults.~     Period of treatment and follow-up will be 16 months.~   "
104363|NCT02201355|"~     Primary Objectives:~      To determine whether patients with T1/2N0-2 Squamous Cell Carcinoma of the oropharynx,~     hypopharynx or larynx can tolerate treatment with cisplatin chemoradiation in three weeks~     using reduced volume IMRT~      Secondary Objectives:~      To describe the adverse events associated with hypofractionated, reduced volume cisplatin~     chemoradiation.~      To estimate response rates and progression-free survival rates of hypofractionated, reduced~     volume cisplatin chemoradiation.~      To determine HRQOL following hypofractionated, reduced volume cisplatin chemoradiation.~      If patients can safely be treated in three weeks rather than six weeks, such a schedule would~     provide a much more convenient alternative for patients and result in a significant reduction~     in the health care resources currently expended on cure of these patients.~   "
104364|NCT02201342|"~     To determine the pharmacokinetic profile and safety of udenafil in adolescents with Fontan~     physiology and to assess the short-term pharmacodynamic effect of udenafil on pharmacodynamic~     measures of exercise capacity, ventricular performance, and vascular function.~   "
104365|NCT02201329|"~     To identify the maximum tolerated dose or recommended dose for further development of~     volasertib in combination with azacitidine in Japanese patients with myelodysplastic~     syndromes or chronic myelomonocytic leukemia, and evaluate the safety and tolerability,~     pharmacokinetics and the preliminary efficacy of this combination.~   "
104366|NCT02201316|"~     This study aims to determine the relative bioavailability of two candidate formulations of~     mosapride citrate 5mg tablets compared the reference product GASMOTIN (mosapride citrate 5mg)~     from Dainippon Pharmaceutical Company in healthy adult subjects. This will be an open-label,~     randomised, single dose, three-way crossover, six sequence study. Subjects will receive a~     single oral dose separated by at least 7 days and no greater than 14 days washout period.~     This study is required to select a candidate mosapride citrate (GR107719B) formulation for~     further development and provide data to allow the design of a future pivotal bioequivalence~     study. The candidate formulations will be compared with the innovator GASMOTIN. GASMOTIN is a~     trademark of Dainippon Sumitomo Pharmaceutical Company.~   "
104367|NCT02201303|"~     This study is to determine danirixin (GSK1325756) concentrations required to inhibit~     neutrophil activation in blood obtained from Respiratory Syncytial Virus (RSV)-infected~     children <2 years and healthy adults. The study will evaluate differences in neutrophil~     activation between RSV-infected children <2 years and healthy adults with escalating~     concentrations of Chemokine (C-X-C motif) Ligand 1 (CXCL1) and danirixin to determine if~     RSV-infected children and adult neutrophils are similarly activated by CXCL1 and inhibited by~     danirixin. This study will guide dose prediction to inhibit specific percentages of~     neutrophils in future pediatric RSV-infection studies. This single-center, in vitro study~     will consist of 2 parts. Approximately 24 subjects will be enrolled, including 12 healthy~     adults and 12 RSV-infected children <2 years.~   "
104415|NCT02200679|"~     The aims of the national population-based study on Autism Spectrum Disorder (ASD) include:~     (1) to understand the overall prevalence of ASD in children aged 6-12 years in 8 cities~     (n=120,000), (2) to explore environmental and genetic risk factors associated with ASD~   "
104369|NCT02201277|"~     This research study is a prospective randomized trial evaluating the relative safety of two~     inferior vena cava (IVC) filters used to prevent the migration of potentially dangerous~     deadly blood clots from the legs to the lung in patients who cannot take blood thinners. All~     eligible patients will have been ordered to have a IVC filter placed by their primary medical~     team and filters will be placed in these patients whether or not they wish to participate in~     this trial as part of standard of care. The investigators will follow up with patients 30~     days after IVC filter placement and ask them to come back for filter removal if medically~     appropriate. If removal is not medically appropriate in 30 days, the investigators will~     attempt to schedule removal every 30 days after initial placement.~      Primary outcome measures will be IVC filter complications such as filter penetration through~     the IVC wall and into other organs, filter tilt, filter migration, filter fracture and clots~     formed within the filter. All of these are reported complications of all IVC filters.~      The research also aims to improve the standard of care for IVC filter patient follow up as~     the FDA and Society of Interventional Radiology recommend that IVC filters be removed as soon~     as it is safe to do so.~      Hypothesis:~      The investigators hypothesize that there is no significant difference in efficacy and~     complication rate between the Option and the Denali filter.~   "
104370|NCT02201264|"~     The proposed study is a registry of patients treated with primary angioplasty for acute~     myocardial infarction.~      The aim of this registry is to define the outcomes of patients treated for acute, ST-segment~     myocardial infarction (STEMI) at community hospitals without on-site cardiac surgery programs~     that have completed the C-PORT Primary Angioplasty Development program. The primary medical~     outcome for the registry is the combined incidence of death, recurrent non-fatal myocardial~     infarction and stroke.~   "
104371|NCT02201251|"~     The purpose of this study is to evaluate the safety of topiramate monotherapy compared with~     levetiracetam another standard antiepileptic drug (AED), as monotherapy for new-onset or~     recent-onset epilepsy (seizure disorder) on pediatric growth and maturation, bone~     mineralization, and kidney stone formation in children aged 2 to 15 years.~   "
104372|NCT02201238|"~     This research study is being conducted to characterize the pharmacokinetic properties of a~     new topical medication (MFC51123) that contains two active ingredients (diclofenac and~     menthol) in two formulation packages. One formulation package is in the form of a gel in~     aluminum tube and the other one in the form of a gel in roll-on applicator bottle.~     Additionally, as a comparison, the pharmacokinetic properties of a marketed diclofenac gel~     and an oral diclofenac treatment will also be characterized. This topical diclofenac/menthol~     gel has being developed to treat mild to moderate pain and inflammation, such as acute sport~     injuries, sprains and strains. The rationale for conducting the study is to prove that~     repeated topical treatment of the new diclofenac + menthol formulation in either of the two~     packages does not result in unsafe systemic exposure.~   "
104373|NCT02201225|"~     This methodology study will evaluate the sensitivity in using sitting knee digital caliper to~     measure changes in sitting knee length from over a 12-week study period amidst children in~     the age of 6 to 12 years in a community-based study in children ages 6 to 12 years who are~     receiving nutritional supplementation with micronutrients or without micronutrients.~   "
104374|NCT02201212|"~     In this research study, the investigators are evaluating the clinical benefit of everolimus~     in cancer patients with inactivating TSC1 or TSC2 mutations or activating MTOR mutations.~      This research study is a Phase II clinical trial, which tests the safety and effectiveness of~     an investigational drug called everolimus to learn whether the drug works in treating a~     specific cancer. Investigational means that the drug is being studied. It also means that~     the FDA (the U.S. Food and Drug Administration) has not yet approved everolimus for your type~     of cancer.~      Everolimus is a drug that may stop cancer cells from growing by blocking an important factor~     (mTOR) involved in the growth of cells. This drug has been used in treatment for other~     cancers and is approved by the Food and Drug Administration for treatment of several types of~     cancer, including renal cell carcinoma. Treatment with this drug has been associated with~     responses in some patients whose cancers had mutations in TSC1 or TSC2. The investigators~     think that patients whose tumors have mutations in TSC1 or TSC2 may have a good chance of~     responding to treatment with drugs like everolimus.~   "
104375|NCT02201199|"~     Primary Objective:~      To compare the pharmacokinetic (PK) characteristics of single doses of insulin glargine given~     as U200 and U500 with those of a single dose (SD) of Lantus® U100 in a euglycemic clamp~     setting in subjects with type 1 diabetes.~      Secondary Objectives:~      To compare the metabolic activity characteristics of single doses of insulin glargine given~     as U200 and U500 with those of a single dose of Lantus® U100 in a euglycemic clamp setting in~     subjects with type 1 diabetes.~      To assess the safety and tolerability of single doses of U200, U500 and Lantus® U100 in~     subjects with type 1 diabetes.~   "
104376|NCT02201186|"~     Patients with a bowel condition called ulcerative colitis have bowel surgery in which a~     portion of their bowel is removed and the reconnected at the small bowel to the anus.~     Sometimes, after the surgery, this connection part, the pouch, would be inflamed in a~     condition called Acute Pouchitis. Physicians usually treat them by prescribing antibiotics;~     however, some patients do not respond and need additional surgery. In this study, we will~     test an alternative treatment for this complication by performing manuka honey enemas twice a~     day for 30 days. This is a pilot study and ten patients will undergo enema treatment.~   "
104389|NCT02201017|"~     A total of 621 consecutive male and female subjects, without established CAD, referred to~     exercise stress testing (EST) due to 1) chest pain syndromes or equivocal/equivalent angina~     with intermediate pretest probability for CAD; 2) , or asymptomatic subjects with diabetes~     mellitus who are referred EST for risk assessment prior to initiation of an exercise program.~      To validate the diagnostic performance of the HeartTrends device for the detection and ruling~     out of myocardial ischemia in a population of subjects who are currently referred for~     cardiovascular evaluation using EST.~      Prospective multicenter single-armed study, assessing the diagnostic accuracy of HRV analysis~     by the HeartTrends device for the detection of myocardial ischemia, as determined by stress~     echocardiography.~   "
104547|NCT02198937|"~     Investigation on the effect of smoking on thrombus formation in humans. The expression of~     pro- and anti-thrombotic, anti-oxidative, and inflammatory markers will be assessed in 25-50~     year old healthy smokers and non-smokers. The investigators are interested in possible~     differences between the two groups.~   "
104377|NCT02201173|"~     People with spinal cord injury (SCI) suffer from secondary health conditions that can result~     in undue physical challenges and impact participation in activities in everyday life.~     Locomotor Training (LT) has been shown to demonstrate improvements in balance and walking~     function in both the animal and humans by reactivating spinal circuits through intensive~     therapy of muscles below the level of the injury. However, it is not known if LT also has~     beneficial health effects and it is the focus of this study proposed to be undertaken at~     Stony Brook University (SBU) as the lead site. LT is thought to produce activation of spinal~     networks to help recover balance and walking after SCI and may correspond with improvements~     in health measures such as bladder function, breathing capacity, cholesterol and other~     cardiac risk factors markers, and the ability to stand upright without drops in blood~     pressure resulting in a sensation of dizziness. LT takes place on a treadmill with the body~     weight supported in a harness, while walking overground and with the practice of key~     exercises in the home and community. The emphasis is on loading the body through the legs~     without braces and other devices except where necessary to function at home. The overall~     objective of this study to capture and analyze health outcome data collected on 80 patients~     enrolled in the 7 NeuroRecovery Network (NRN) clinics in the USA who receive LT. The NRN is~     funded by the Christopher and Dana Reeve Foundation and the CDC to implement LT for people~     with SCI. The purpose of this application is to leverage the NRN funding, that provides~     support for LT and standardized outcome measures, to generate further knowledge on health~     outcomes after LT for individuals with SCI. The proposed project will be accomplished through~     the utilization of staff at each of the 6 NRN sites, lead by the study principal investigator~     and the lead clinical research coordinator at SBU. They will ensure the data are captured~     before and after LT in a standardized manner, at the correct time and entered into a~     de-identified database. The study hypotheses are that after LT, compared to before, patients~     with SCI will improve lipid profiles and insulin factors as measured by fasting blood tests;~     respiratory function as measured by specialized but easy to use breathing equipment; and~     blood pressure and heart rate during a maneuver to test for responses to abrupt changes in~     posture. The relevance of this proposal is that it will help to determine if there is an~     association between an intensive activity- based intervention (LT) and improvements in health~     and will be used to form the basis for a larger randomized clinical trial and clinical~     practice guidelines.~   "
104378|NCT02201160|"~     Nonalcoholic hepatic steatosis (NASH) is defined as the amount greater than 5% of the total~     liver volume fat. Commonly known as NASH, it includes 4 stages histological ranging from the~     mere presence of fat to the existence of fibrosis and degeneration of hepatocytes, and~     finally a progression to cirrhosis, sometimes accompanied by complications of hepatocellular~     carcinoma. It is a common condition associated with a combination of disorders, namely~     obesity, insulin resistance and type 2 diabetes. The link with the metabolic syndrome (MetS)~     was mainly studied in the adult population and very little in the paediatric population,~     while 15 and 25% of obese children are affectés. The severity of histological disease appears~     to be associated with the degree of obesity in children and particularly in the MetS. in~     addition, epidemiological data indicate that the incidence of this disease is increasing in~     children and positioning as the first NASH liver disease in North America. the revelation of~     the factors associated with the occurrence of NASH is a first necessary step to understanding~     this disorder worrying for the future of children and adolescents. In addition, clarification~     of the mechanisms responsible for its development is essential if the investigators want to~     consider targeted and effective treatments to slow the rat race of NASH, which stands out as~     the supreme chronic liver accompanying the obesity and MetS. Finally, in view of growth and~     puberty of children, it would be extremely beneficial to find nutritional avenues that would~     avoid the side effects of chemical agents.~   "
104379|NCT02201147|"~     The purpose of this study is to compare cold snare polypectomy and cold forceps polypectomy~     using narrow-band imaging endoscopy for removal of diminutive colorectal polyps.~   "
104380|NCT02201134|"~     Studying the feasibility of an initial sedation with inhalated sevoflurane during therapeutic~     hypothermia of cardiac arrests resuscitated patients.~   "
104381|NCT02201121|"~     Although induced hypertension decreased SVV and PPV,the influences of stroke volume variation~     and pulse pressure variation caused by phenylephrine,dopamine and ephedrine were unknown.~   "
104382|NCT02201108|"~     Primary Objective:~      To assess the effect of teriflunomide in comparison to placebo on disease activity measured~     by time to first clinical relapse after randomization in children and adolescents 10 to 17~     years of age with relapsing forms of multiple sclerosis.~      Secondary Objectives:~        -  To assess the effect of teriflunomide in comparison to placebo on disease~          activity/progression measured by brain MRI and on cognitive function.~        -  To evaluate the safety and tolerability of teriflunomide in comparison to placebo.~        -  To evaluate the pharmacokinetics (PK) of teriflunomide.~   "
104383|NCT02201095|"~     During anaesthesia for caesarean section it is common to lose heat and become hypothermic,~     (<36 degrees C). In order to try and avoid this all women are given warmed intravenous fluid~     and insulated from cold surfaces. There are also 2 types of machine available to actively~     warm women;~        1. Forced Air Warming - that uses a disposable sheet the woman lies upon with lots of air~          pockets that have warm air blown into them continuously by a fan.~        2. Conduction Warming Mattress - a thin mattress which covers the operating table and the~          woman lies on top. The padded mattress has strips of material that heat up when~          electricity passes through it, similar to a normal electric blanket.~      We plan to carry out a randomised controlled trial to compare these 2 methods with the~     current practice of no active warming.~      The hypothesis for this study is that active warming women during elective caesarean section~     prevents women's temperature from dropping and keeps them more comfortable than if active~     warming were not used.~   "
104384|NCT02201082|"~     The purpose of this study is to determine the optimal time for the nebulization depending on~     the respiratory physiotherapy session in cystic fibrosis patients.~   "
104385|NCT02201069|"~     The My Health Coach Study seeks to determine if health coaching by a medical assistant can~     help patients have better sleep, a better diet, be more physically active or lose weight,~     according to the recommendation of their health care provider.~   "
104386|NCT02201056|"~     The purpose of this study is to characterize the safety and tolerability profile of TAK-935~     in healthy participants when administered as a single dose of oral solution at escalating~     dose levels.~   "
104387|NCT02201043|"~     1. Evaluate the efficacy and safety of taking thalidomide tablets once daily in the~          treatment of active ankylosing spondylitis.~        2. To explore dose-effect relationships of taking thalidomide tablets once daily in the~          treatment of active ankylosing spondylitis, as well as selecting the appropriate dose~          for the further larger scale clinical trials.~   "
104388|NCT02201030|"~     This study will assess the immunogenicity and safety of primary vaccination with NBP606~     compared to the existing commercial vaccine, when given concomitantly with routine pediatric~     vaccinations.~   "
104413|NCT02200705|"~     To evaluate the efficacy of cryoablation without lumpectomy and its impact on local and~     distant recurrence of early stage breast cancer .~   "
104390|NCT02201004|"~     Primary Objectives:~      To assess the effects of tofogliflozin on glycemic control in comparison to placebo as an~     add-on treatment to insulin treatment in terms of glycated hemoglobin (HbA1c) reduction over~     a period of 16 weeks in patients with type 2 diabetes mellitus.~      To assess the safety of tofogliflozin in combination with insulin treatment throughout 52~     weeks.~      Secondary Objectives:~      To assess the effects of tofogliflozin in comparison to placebo on:~        -  Body weight~        -  Fasting plasma glucose (FPG)~        -  Postprandial plasma glucose (PPG) To assess the long term safety and tolerability of~          tofogliflozin.~   "
104391|NCT02200991|"~     Primary Objective:~      To demonstrate significant reduction in postprandial plasma glucose (ΔAUC0:30-4:30h) after a~     standardized breakfast from baseline to Day 29.~      Secondary Objectives:~      To demonstrate:~        -  Changes from baseline to Day 29 in maximum postprandial plasma glucose excursion,~          C-peptide and glucagon levels after a standardized breakfast~        -  Delaying gastric emptying (13C-acetic acid breath test)~        -  Safety and tolerability~   "
104392|NCT02200978|"~     Outcome of acute promyelocytic leukemia (APL) has greatly improved since the introduction of~     all-trans-retinoic acid (ATRA). Treatment with ATRA and anthracycline-based chemotherapy~     (ATRA + chemotherapy) decreases relapses of the disease as well as early hemorrhagic deaths.~     Nowadays patients with APL have an event-free survival (EFS) of up to 80%. However, there~     remains a subset of the patients in whom the disease relapses. Recently, a randomized~     prospective study showed that the addition of ATO to ATRA + chemotherapy treatment protocol~     had a significantly higher EFS in patients with APL than those treated with ATRA +~     chemotherapy protocol. The patients treated with ATO + ATRA + chemotherapy had a five~     years EFS of 89.2%. Moreover, a recent study showed that Indigo naturalis formula (RIF), a~     traditional Chinese medicine with tetraarsenic tetrasulfide (As4S4), indirubin, and~     tanshinone IIA as major active ingredients, yielded synergy in the treatment of a murine APL~     model in vivo and in the induction of APL cell differentiation in vitro . It is about 20~     years since RIF was used to treat ALP in China. Clinical studies showed that this agent was~     effective against APL. Compared to ATO, RIF is relatively inexpensive and can be taken~     orally, resulting in reducing the number of hospital days and the treatment cost. However,~     there is no report comparing treatment outcomes of ATO + ATRA + chemotherapy and RIF +~     ATRA + chemotherapy protocols in children with APL so far. For this purpose, therefore,~     investigators are going to conduct a multicenter and randomized prospective study in children~     with APL.~   "
104393|NCT02200965|"~     Health professionals usually lead in the management of long term conditions such as Diabetes.~     In a conventional professionally driven compliance model of care, patients may be placed in a~     secondary role. National audits show components of systematic diabetes care consistently fail~     despite several years of heavy expenditure in the service focused Diabetes Quality and~     Outcome Framework. To what extent is this due to the nature of that process which may not~     engage patients nor be focused on informed patient centred concerns? The aim of this research~     is to determine the effectiveness of a healthcare delivery approach in which patients,~     empowered with structured guidance and specific information about their diabetes, take~     decisions to get involved in their diabetes care as determined in hard measures of engagement~     and outcomes. The methodology will be by a whole population cluster randomised controlled~     study of an intervention the delivery of an individualised diabetes specific structured~     report, and we will look at its impact on measured key diabetes access and process outcomes.~     The contention is that the patients, guided in their understanding of empowerment and~     enablement, equipped with highly person specific risk stratified outcome based information,~     and informed regarding which actions they may accordingly take, will be enabled to make a~     significant and impactful contribution in improvement in their own care . This large scale~     project can deliver on that research question in a tested , efficient and cost effective~     manner.~   "
104394|NCT02200952|"~     The purpose of this study is to prove that luteal phase supplementation with recombinant LH~     can solve the luteal phase deficiency after Gnrh agonist oocytes triggering in women at risk~     of OHSS~   "
104395|NCT02200939|"~     The purpose of this study is to evaluate bioinduction of new tissue and tendon healing after~     implantation of the Rotation Medical Bioinductive Implant used as either a standalone device~     or adjunct to surgical repair in the treatment of supraspinatus tendon tears.~   "
104396|NCT02200926|"~     The previous studies used the slow loaded breathing device for breathing training (Jones et~     al., 2010). It has been shown that slow loaded breathing training can reduce resting blood~     pressure and heart rate in essential hypertensive patients. However, this has not been~     studied in elderly with essential isolated systolic hypertensive patients. Not only highest~     prevalence of hypertension in Thailand was found in elderly but also physiological changes in~     the elderly are cause of interest in this special population. It has many advantages to use a~     slow loaded breathing training in elderly people. Firstly, it is low technology and easily~     implemented at home. Secondly, it can be practiced almost anytime and anywhere. Thirdly, the~     orthopedic complications of slow loaded breathing training are minimal. Finally, slow loaded~     breathing training may be enhancing cardiopulmonary function and other fitness traits, but it~     out of scope of this study. Moreover, slow loaded breathing exercise by itself should not~     result in any metabolic adaptation of skeletal muscles, such as the forearm, which had not~     been trained. If slow loaded breathing training modified some central component of the~     pressor reflex pathway in a way that single muscle training might work, as suggested above,~     then loaded breathing training would have a modulating effect on the pressor responses of~     muscles that had not been trained.~      We, therefore, aim to study the effect of slow loaded breathing training by using Breathmax~     on blood pressure at rest and exercise in elderly with essential isolated systolic~     hypertension and also investigate the autonomic function and others that may be involved with~     the changed blood pressure in elderly with essential isolated systolic hypertension. We~     hypothesized that slow loaded and unloaded breathing training could reduce resting and~     exercising blood pressure in elderly with essential isolated systolic hypertension.~   "
104397|NCT02200913|"~     Recent studies indicate that patients with chronic low back pain (LBP) present problems in~     balance. Alterations in proprioception are the possible causes of alteration of postural~     balance in LBP.~      Previous studies reported an improvement of CSE on joint mobility, pain, functional~     disability, and trunk muscle activation pattern in patients with clinical lumbar instability~     (CLI); however, it was an immediate effect. However, previous studies did not report indirect~     effect may occur in CLI as postural balance and other kinds of exercise as strengthening in~     CLI. The general trunk strengthening exercise is common used in physical therapy clinic on~     LBP, that improve pain, physical disability, and trunk muscles activity. To our knowledge,~     the usefulness of CSE has not yet been investigated in CLI patients with outcome measure of~     balance.~      The present study will conduct to fill the gaps of previous studies which will provide~     immediate-, accumulative- and detraining-effects of CSE on postural balance, pain intensity~     and ratio activation of trunk muscles and included blinding process of the assessor.~   "
125488|NCT01924923|"~     This pilot study intends to investigate a new biopsy technique that will decrease the~     incidence of tumor cells in the biopsy tract.~   "
104398|NCT02200900|"~     The most commonly used noninvasive respiratory support in preterm babies is Continuous~     Positive Airway Pressure (CPAP), which provides extra breathing support to babies who are~     breathing by themselves). Increasingly High flow Nasal Cannula (HFNC, newer form of extra~     breathing support) therapy has found its way in clinical practice despite lack of good~     physiological data. There are also concerns about its potential to generate higher pressures~     in airways which can cause over distension of lungs.~      We would like to find out the effects of HFNC on~        -  1. Airway pressures in various flow rates and in comparison to CPAP.~        -  2. Breathing markers including respiratory rate (speed of breathing), oxygen and carbon~          dioxide levels, tidal volumes (how much air breathed in with each breath) and airway~          wash out (wash out of waste gas from the airway).~      We plan to study 15 babies each in three different weight categories supported with either~     CPAP or HFNC. The airway pressures, oxygen and carbon dioxide concentration in airway are~     measured by a small plastic catheter (similar to feeding tube but much shorter in length),~     carbon dioxide levels by skin sensors, how fast and how much babies breathe by a special vest~     applied like a layer of clothing. These will be recorded both on HFNC and CPAP. There are no~     blood tests or invasive procedures involved. The baby will be monitored throughout the study~     period of approximately two hours by experienced registrar who is trained to use the study~     device.~      This study will improve our understanding of physiological effects of HFNC and lead to better~     care of preterm babies.~   "
104399|NCT02200887|"~     Parkinson's disease is characterized in the advanced phases by an altered response to~     dopaminergic therapy for the occurrence of abnormal movements called dyskinesias, that~     worsens the quality of life of the patient and exposes him to comorbidities. Several data~     show a reduction in the amount of slow wave sleep that correlates inversely with disease~     duration. Since this stage of sleep is linked to mechanisms of deletion of superfluous~     information the investigators hypothesize that the onset of dyskinesias is related to such~     alteration of sleep.~      -This study is aimed to investigate, by means of high-density electroencephalography~     (hd-EEG), the sleep and in particular the slow wave in order to clarify the relations with~     the development of dyskinesias.~   "
104400|NCT02200874|"~     The purpose of this study is to investigate the effectiveness and efficiency of a structural~     clinical nutrition support by an interdisciplinary Nutrition Support Team. To do this we~     examine nutritional management and its economic impact as well as the nutritional status of~     patients of University Hospital Tübingen before and after the implementation of a Nutritional~     Support Team.~   "
104401|NCT02200861|"~     In this study it's aimed to evaluated the patients in whom dental local anesthetic attempts~     were failed due to anxiety or fear and referred to our clinic for tooth extraction with deep~     sedation. All patients dates will evaluate from their patient file retrospectively from 2011~     to 2014.~   "
104402|NCT02200848|"~     This study is for subjects diagnosed with recurrent or relapsed CLL/SLL. The purpose of this~     study is to test the safety of the combination of the drugs lenalidomide and ibrutinib at~     different dose levels, in combination with the drug rituximab. We want to find out what~     effects, good and/or bad, they have on patients with CLL/SLL.~      The hypothesis of the study is that it will be safe to give the three drugs in combination~     and the information learned from this trial will be used to study the 3 drug combination is a~     larger future trial.~   "
104403|NCT02200835|"~     Few data exist on gender-related differences in clinical features, management, and outcomes~     of acute aortic dissection (AAD) in China. Accordingly, we enrolled 2015 patients with AAD~     from 15 hospitals in China to access differences in clinical features, management and~     outcomes between men and women. in this study, our results provided new insights into~     gender-related differences in clinical features, management and outcomes in the Chinese~     patients with AAD. Important implications may be helpful to improve diagnostic and~     therapeutic outcomes.~   "
104404|NCT02200822|"~     The primary objective of this study is to demonstrate that in patients with~     recuperated/normalized left ventricular function, defined as an ejection fraction (EF) ≥ 50%,~     after implantation of cardiac resynchronization therapy, device treatment is sufficient and~     neurohumoral blocker therapy can safely be withdrawn~   "
104405|NCT02200809|"~     Purpose of the investigators study is to determine the short and medium term histological~     cancer control of focal therapy using MR-guided focal laser ablation therapy in the treatment~     of localised prostate cancer.~   "
104406|NCT02200796|"~     Objectives: To determine the effect of protein content of familiar breakfast meals on~     subjective appetite, food intake (FI), glycemic response and Thermic Effect of Food (TEF) in~     normal weight (NW) and overweight (OW)/obese (OB) children.~      Specific Objectives:~      1a.To determine the effect of familiar breakfast meals (450 kcal containing eggs and varying~     in protein content (15, 30, and 45g) on subjective appetite, glycemic response and food~     intake at a test meal 4 h later in NW and. OW/OB children.~      1b. To describe the effect of isocaloric (450 kcal) familiar breakfasts either high in~     protein (optimal protein from Objective 1a) or low in protein on TEF and substrate~     utilization over 5 h in NW and OW/OB children.~   "
104407|NCT02200783|"~     Excessive radiation received by the operator has been described as a possible drawback of the~     radial catheterization technique when compared with the femoral access.~      The study hypothesis is that the use of radial access device dedicated radioprotective~     TRIPTable ® (Transradial Intervention Table Protection) is not inferior to standard femoral~     technique and superior to standard radial technique as radioprotection strategy to the~     operator in patients with acute coronary syndromes acute and submitted to cardiac~     catheterization.~   "
104408|NCT02200770|"~     To compare the efficacy of MEDI-551 versus placebo in reducing the risk of an NMO/NMOSD~     attack in subjects with NMO/NMOSD.~   "
104409|NCT02200757|"~     The purpose of this study is to evaluate the efficacy and safety of aldoxorubicin compared to~     topotecan in subjects with metastatic small cell lung cancer.~   "
104410|NCT02200744|"~     The purpose of this study is to determine the incidence of recall in patients managed in~     emergency department with a procedural sedation protocol using propofol in a population of~     250 .~   "
104411|NCT02200731|"~     To investigate whether a home-based psychosocial family intervention that takes place shortly~     after ending the primary medical treatment can help families adjust to their cancer-related~     psychological issues.~   "
104412|NCT02200718|"~     A Phase I Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple~     Sclerosis to demonstrate safety & efficacy~   "
104416|NCT02200666|"~     The purpose of the investigation is to confirm the following under the post-marketing actual~     use of Forxiga Tablets (hereinafter referred to as Forxiga)~        -  Development of ADRs specified as Key Investigation Items and the risk factors~        -  Contributing factors possibly having an impact on the safety and efficacy~        -  Development of ADRs unexpected from the Precautions for use and ADRs under actual drug~          use~   "
104417|NCT02200653|"~     The primary aim of the trial is to compare the influence of MICARDIS® (telmisartan) and~     COZAAR® / LORZAAR® (losartan) in lowering ambulatory diastolic blood pressure (DBP) during~     the last 6 hours of the 24-hour dosing interval as measured by ABPM. Secondary objectives~     include evaluations of: 1) change from baseline in mean systolic blood pressure (SBP) during~     the last 6 hours of the 24-hour dosing interval as measured by ABPM, 2) changes from baseline~     in SBP and DBP during other periods during the 24-hour ABPM profile, 3) changes from baseline~     in mean seated trough SBP and DBP as measured by manual cuff sphygmomanometer, and 4)~     responder rates based on both ABPM and trough cuff blood pressure~   "
104418|NCT02200640|"~     The primary aim of the trial is to compare the influence of MICARDIS® (telmisartan 40-80 mg)~     and COZAAR® (losartan 50-100 mg) in lowering ambulatory diastolic blood pressure (DBP) during~     the last 6 hours of the 24-hour dosing interval as measured by ABPM after 8-weeks treatment.~     Secondary objectives include evaluations of: 1) change from baseline in mean systolic blood~     pressure (SBP) during the last 6 hours of the 24-hour dosing interval as measured by ABPM, 2)~     changes from baseline in SBP and DBP during other periods during the 24-hour ABPM profile, 3)~     changes from baseline in mean seated trough SBP and DBP as measured by manual cuff~     sphygmomanometer, and 4) responder rates based on both ABPM and trough cuff blood pressure~   "
104419|NCT02200627|"~     The purpose of the investigation is to confirm the following under the post-marketing actual~     use of Forxiga Tablets (hereinafter referred to as Forxiga) in elderly patients.~        -  Development of ADRs specified as Key Investigation Items and the risk factors~        -  Contributing factors possibly having an impact on the safety and efficacy~        -  Development of ADRs unexpected from the Precautions for use and ADRs under actual drug~          use~   "
104420|NCT02200614|"~     The purpose of this study is to assess the safety and efficacy of BAY1841788 (ODM-201) in~     patients with non-metastatic castration-resistant prostate cancer.~   "
104421|NCT02200601|"~     The study sponsor has developed a patented medical device called Seipher Wellness. This is a~     non-invasive medical device that assesses heart health based on established cardiac~     parameters; timing events of the cardiac cycle. These are specific parameters captured and~     analyzed by the device. A ratio of two specific timing parameters provides an assessment of~     the subject's overall heart health. The aim of this study is to validate the device algorithm~     across a range of subjects.~   "
104422|NCT02200588|"~     Schizophrenia is a chronic brain disease that is still understood as a condition that limits~     the development of a normal life for the patient who suffers it and their families. The idea~     that only one third of patients have a good outcome is still in force, despite the lack of~     clinical and epidemiological longitudinal studies that have addressed this issue rigorously.~     Most studies that have established the poor prognosis of the disease have followed a~     cross-sectional design and are based on samples of patients undergoing treatment in~     healthcare devices and therefore represents an important bias. Based on clinical, cognitive,~     functional outcome and biomarkers studies (brain imaging) to medium term (3 years) we can~     establish that the particular idea of poor prognosis should be reconsidered. The development~     of longitudinal studies of first-episode patients in representative samples of a population~     and long-term it is of high value to shed light on the clinical course of the disease. The~     belief that there are factors determining the disease progression beyond the initial three~     years brings us to publish this study.~      Given this background, our project's main objective is to know the evolution at 10 years of~     patients followed in the First Episode Psychosis Clinical Program (PAFIP). Our hypothesis is~     that a higher percentage of expected patients have a favorable outcome of the disease.~     Factors such as enhancing treatment completion, abstinence from drug use, return to work, the~     reduction of expressed emotion in families during the early years of the disease (at least 3~     years of intensive intervention PAFIP) will have a positive impact on the evolution of~     patients on long-term (10 years). Our hypothesis defends the existence of certain factors as~     independent risk factors for poor clinical and functional outcome of patients who should be~     known for establishing intervention strategies that attempt to mitigate their impact on the~     quality of life of patients and their families.~   "
104423|NCT02200575|"~     Study to confirm the safety profile of telmisartan (benefit-risk ratio) under normal~     conditions of use after market launch and to supplement the present data on the safety of~     telmisartan. Furthermore to assess effectiveness of a single dose of telmisartan per day to~     control blood pressure for 24 hours, especially during the last few hours of the dosage~     interval. Additionally to evaluate compliance with treatment, as an indirect measurement, and~     to confirm the efficacy and possible risks associated with treatment.~   "
104424|NCT02200562|"~     Phase I/II study of ipilimumab concurrent ipilimumab and dabrafenib as first line treatment~     in Stage III or IV melanoma.~      Assessing safety of Ipilimumab and dabrafenib in combination. Also, assessing disease control~     rates.~   "
104425|NCT02200549|"~     Chronic Obstructive Pulmonary Disease (COPD) ，the fourth leading cause of death in the world,~     represents an important public health challenge. It is also a major cause of chronic~     morbidity, mortality and disability throughout the world, leading to a heavy social and~     economic burden. For a long time, treatment of COPD mainly focus on drug therapy. Recently,~     pulmonary rehabilitation is recognized as a core component of the management of individuals~     with chronic respiratory disease, which has been clearly demonstrated to reduce dyspnea,~     increase exercise capacity, and improve quality of life.~      Exercise training, widely regarded as the cornerstone of pulmonary rehabilitation , is one of~     the best available means of improving muscle function in COPD.The most commonly form is cycle~     training. Inspiratory Muscle Training (IMT) as an adjunct to exercise training has an~     additional benefit on inspiratory muscle strength, endurance and exercise capacity in patient~     with COPD.~      There is insufficient evidence demonstrate greater benefits from combined inspiratory muscle~     training and cycle training. This study will evaluate the effects of combined inspiratory~     muscle training and cycle training in patients with COPD.~   "
104436|NCT02200393|"~     Compromised respiratory function as a result of tetraplegia leads to many tetraplegics~     requiring mechanical ventilation during the acute phase of injury. Mechanical ventilation is~     associated with additional costs to the local health care provider and reduced quality of~     life of the patient. Electrical stimulation of the abdominal muscles has previously been used~     to improve the respiratory function of tetraplegic patients in the chronic stage of injury.~     In this study the investigators aim to evaluate whether electrical stimulation of the~     abdominal muscles can assist the process of weaning from mechanical ventilation in acute~     ventilator dependent spinal cord injured patients.~   "
104426|NCT02200536|"~     Governmental initiatives (such as Sure Start in the UK) have integrated an oral health~     promotion intervention within their maternal and child health program and delivered dental~     education and enabling resources (a gift bag including a baby toothbrush, fluoride toothpaste~     and a trainer cup) to infant's mothers. Whilst this approach has minimal financial~     implications of human resources, no evidence exists regarding its effectiveness in~     establishing desirable infant's oral health behaviours. In Syria, there is a great need for~     developing an infant's oral health promotion program to promote oral hygiene practice,~     provide access to fluoride and terminate bottle-feeding practice. Thus, the current study~     aimed to test the effectiveness of an integrated infant's oral health promotion intervention~     within the Syrian national immunization program, which delivered printed dental education~     materials, a baby tooth brush, fluoride toothpaste (1000 ppm) and a trainer cup, in~     establishing one-year old infant's oral hygiene and bottle-feeing termination practices.~   "
104427|NCT02200523|"~     The SARA (Self Abrading Rapidly Applied) electrode will speed EEG patient hookup by combining~     multiple steps that burden conventional EEG procedures into one. The investigators believe~     that the proposed system will reduce patient hookup time by more than 50% (from 40 to 20~     minutes) with additional time savings on cleanup. Reducing the hookup time required for the~     EEG recording will make EEG more feasible in time critical situations and will improve~     patient care and service. The clinical testing in Phase II will investigate patient~     acceptance, clinician acceptance, time savings, and signal quality for 3 different~     environments: the large hospital institution, a small rural hospital setting and in an~     emergency department.~   "
104428|NCT02200510|"~     The purpose of the study is to develop patient-provider clinical support tools to improve~     clinical practice, patient self-management, and disease outcomes in sickle cell disease~     during transition to adult care. The investigators hypothesize that these clinical support~     tools (patient tool, provider tool, and patient/parent web-based portal) will be feasible,~     user friendly, and beneficial. The investigators hypothesize that participants will~     demonstrate better disease self-efficacy at the end of the 6 week intervention and maintain~     these gains during the follow-up period (up to 1 year post-intervention).~   "
104429|NCT02200484|"~     Specific Aims:~        1. The primary aims of this study are to conduct formative interviews with teen mothers to~          inform a targeted adaptation of empirically based weight management and parent training~          programs for teen mothers for their preschoolers.~        2. To conduct a small pilot and post-pilot focus group of the feasibility and acceptability~          of recruitment and retention methods & the intervention.~      Study Hypotheses:~      Given the small sample size and fact that this is a pilot study, focus will be on estimating~     effect sizes rather than statistical hypothesis testing. However, the investigators~     exploratory hypotheses are as follows:~        1. (a) The adapted intervention will be more feasible compared to the wellness control~          condition, with a participant retention rate of ≥80% and an average adherence~          (attendance at weekly treatment sessions; homework completion 5 weekdays weekly) is ≥~          75%; (b) The adapted intervention will be more acceptable compared to the wellness~          control condition, based on the Consumer Satisfaction Scale and Therapy Assessment~          Inventory with ≥90% of the participants responding to the item, In general how~          satisfied were you with the intervention? by choosing unsatisfied to very~          satisfied.~        2. (a) The adapted intervention will result in greater improvements in child behavior and~          parent-child connectedness compared to the control condition; (b) the adapted~          intervention versus wellness control condition will result in greater increases in child~          and teen mother individual as well as joint physical activity and physically active play~          and greater reductions in individual and joint teen mother and child sedentary behavior~          (television viewing) from baseline to post-intervention; (c) the greater teen mother and~          child fruit and vegetable consumption; and reduced child juice and sugar-sweetened~          beverage consumption from baseline to post-intervention; (d) the adapted intervention~          versus wellness control condition will result in smaller increases in child BMI~          percentile and teen mother BMI from baseline to post-intervention; (e) participants who~          attend higher numbers of intervention sessions will show greater improvements in target~          outcomes (child behavior, parent-child connectedness, and teen mother and child physical~          activity, sedentary behavior and BMI); with participants receiving the adapted~          intervention versus wellness control showing the greatest dose-based improvements.~   "
104430|NCT02200471|"~     This study aims to understand the impact of VeinViewer technology during routine cosmetic and~     dermatologic procedures.~   "
104431|NCT02200458|"~     This study will look at the performance capabilities of software for VeinViewer.~   "
104432|NCT02200445|"~     The purpose of this study is to determine the safety and maximum tolerated dose (MTD) of~     Interleukin-2 in subjects with moderate-to-severe ulcerative colitis.~   "
104433|NCT02200432|"~     The purpose of this study is to maximize patient perspective and effectively support~     lifestyle choices, investigators will develop the Patient Experience Recommender System for~     Persuasive Communication Tailoring. PERSPeCT is a computer system that will assess adult~     smokers' perspective, to understand the patient's preferences for smoking cessation health~     messages, and provide personalized, persuasive health communication that is useful to the~     individual patient in making positive health behavior changes such as smoking cessation.~   "
104434|NCT02200419|"~     This multi-centre study will provide sound, generalizable data on the effectiveness of a~     POC-based algorithm to determine to what extent this guideline can reduce blood product~     transfusions. Investigators will study outcomes in 7000 patients undergoing heart surgery at~     10 participating hospitals. The proposed trial addresses several important research and~     clinical issues and has the potential to markedly improve the transfusion management and~     surgical care in general of cardiac surgery patients.~      The intervention will be a novel POC-based algorithm that has been shown in a pilot study by~     us to be associated with a substantial reduction in blood product transfusions. The algorithm~     will employ viscoelastic and aggregometric POC-tests and an objective measure of blood loss.~     The primary outcome will be avoidance of red blood cell transfusion during hospitalization.~     The study has a 90% power to detect a 12% increase in avoidance rate. Secondary outcomes will~     include avoidance of red blood cell use and other blood products (plasma, platelets, and~     cryoprecipitate), units of blood products transfused, and adverse clinical outcomes related~     to transfusion (acute kidney injury, infections, and death). Data will also be collected for~     future health-economics analyses.~      Largely due to the limitations of existing evidence, however, such algorithms are rarely used~     in clinical practice. The proposed trial will provide sound, generalizable data on the~     effectiveness of a POC-based algorithm to guide their future use. An integrated blood~     management algorithm that employs POC coagulation tests will reduce blood product~     transfusions in cardiac surgery, thereby improving clinical outcomes.~      Does an integrated blood transfusion algorithm that employs POC coagulation tests applied~     across a network of hospitals reduce blood transfusions and associated adverse outcomes in~     cardiac surgery?~   "
104435|NCT02200406|"~     Background: Although substitution therapy has been shown to be highly effective to retain~     opioid-dependent patients in treatment and reduce drug use, this population is afflicted by~     numerous conditions including depression. Unfortunately, studies published thus far have~     reported inconsistent or no difference in response between placebo therapy and~     antidepressants such as selective serotonin reuptake inhibitors. Objective: To assess the~     feasibility of Desvenlafaxine (DESV) administration among opioid-dependent subjects and~     explore its effect on depressive symptoms. Methods: Open-label pilot trial of 8 weeks of DESV~     50-100 mg/day in 20 methadone-maintained individuals with comorbid depressive symptoms at the~     Centre hospitalier de l'Université de Montréal. Significance: This pilot study will lay down~     the foundation on which a larger multisite clinical trial could be conducted to examine DESV~     as new treatment for opioid-dependent population with comorbid depression.~   "
104437|NCT02200380|"~     This is an open-label, multicenter, prospective pilot study of CDX-301 with or without~     plerixafor as a stem cell mobilizer for allogeneic transplantation (stem cells that come from~     another person). HLA-matched sibling healthy volunteers (donors) and patients with protocol~     specified hematologic malignancies (recipients) will be enrolled.~   "
104438|NCT02200367|"~     In the treatment of depression, primary care team play an important role, but they are most~     effective when inserted into a collaborative model of disease management.~      Hypotheses:Depressed patients treated in rural primary care clinics participating in a~     e-mental heath collaborative programme to manage depression achieve at least 20% better~     recovery rates in comparison with the control group three months after the baseline~     assessment.~      Goal: to compare the effectiveness of a e-mental health collaborative programme with usual~     care in rural primary-care clinics.~      Methodology: a clinical trial with two arms will be conducted in 13 community rural hospitals~     in Chile. The active group will participate in a collaborative programme between primary care~     teams and specialized teams, with support from an electronic platform and a call center.The~     control group will receive usual care, according to the Ministry of Health's Guidelines to~     Depression.To evaluate inclusion criteria -depressive patients aged between 18 and 70 years-~     and exclusion criteria -current in treatment for depression- an interview will be used that~     will include the Mini-International Neuropsychiatric Interview (MINI) to evaluate depression~     .The principal outcome will be depressive symptoms measured with the Beck Depression~     Inventory (BDI-I), and secondary outcome quality of life measured with the Health Survey~     (SF-36) at three and six months after baseline assessment.To detect a difference of 20%, in a~     one-sided model, with an alpha of 5% and power of 80%, would require 152 depressed persons~     (76 to intervention and 76 to control group).A design effect of 1.35 based on an Intraclass~     Coefficient Correlation (ICC) of 0,03839 and 13 clinics were considered. After applying the~     design effect the sample needed increased to 206 depressed persons. Considering a retention~     rate of approximately 85% 237 depressed cases will be needed.~      A program of this kind may be useful to assist primary care teams in remote areas of the~     country, in order to improve treatment outcomes for depression that is currently addressed at~     the primary care level.~   "
104439|NCT02200354|"~     For patients with nonsquamous NSCLC and a good performance status (PS), pemetrexed and~     cisplatin has been recommended for first-line NSCLC treatment. Recently, results from the~     PARAMOUNT trial showed that patients with nonsquamous NSCLC who had a good PS and had not~     progressed after completing four cycles of pemetrexed-cisplatin induction therapy benefitted~     from pemetrexed continuation maintenance therapy. Furthermore, pemetrexed with bevacizumab~     continuous maintenance might be better treatment option, considering the results from~     AVAPEARL trial. Pemetrexed rechallenge has been reported to be effective in some patients.~     Therefore, in order to investigate the safety and efficacy of pemetrexed rechallenge with~     bevacizumab,we conducted this study.~   "
104440|NCT02200341|"~     The purpose of this study is to investigate the effects of Mindfulness-Based Cognitive~     Therapy (MBCT) on brain mechanisms associated with interoceptive awareness and rumination in~     individuals suffering from major depressive disorder (MDD).~   "
104441|NCT02200328|"~     The purpose of this study is to test if metronidazole prophylaxis is effective in decreasing~     the incidence of hospital induced Clostridium Difficile diarrhea among patients at high risk~     for this infection.~   "
104442|NCT02200315|"~     The aim of this study is to evaluate the feasibility and safety of no use of antimicrobial~     prophylaxis during laparoscopic distal gastrectomy for gastric carcinoma.~   "
104443|NCT02200302|"~     Adolescent idiopathic scoliosis (AIS) is a common disorder of unknown etiology in which the~     vertebrae and discs gradually develop a curvature that is first detected in patients between~     11 and 20 years of age. The deformity is 3-dimensional, with a coronal curve measured from~     radiographs by the Cobb angle .~      The Cobb angle measurement of scoliosis represents the sum of the angular wedging of each~     vertebra and disc between the superior and inferior end vertebrae . Although a small curve is~     well tolerated and does not require treatment, a large curve can progress to the point that~     it is cosmetically unacceptable, interferes with chest wall mechanics, and produces cardiac~     and pulmonary compromises. The natural history of AIS apparently includes 2 stages: the~     initiation of the curve and its subsequent progression. The factors responsible for the~     initiation of the curve are unknown, but the subsequent progression of the curve is clearly~     associated with the adolescent growth spurt . The primary risk factors for progression~     include age at onset and the magnitude of the curve; young patients with large curves are at~     the highest risk .~      Although numerous treatment methods have been recommended for patients with AIS, the only~     accepted treatment includes bracing for skeletally immature patients with curves between 25~     and 40 degrees and operative correction with spinal fusion for patients with curves greater~     than 45 degrees. For many teenagers, the cosmetic and social concerns associated with bracing~     has caused compliance problems with wearing the brace and many patients only wear the brace~     at home . While operative intervention completely corrects the scoliosis or rib hump, it~     eliminates segmental spinal motion, and concentrates stresses at the ends of the fusion~     potentially leading to disc degeneration and back pain.~      Despite satisfactory short-term results of operative instrumentation and fusion, a less~     invasive technique preserving more motion with a smaller scar represents a major improvement.~     Realizing this goal is contingent on treating curves early, before they progress to an~     irreversible deformity, and when there is still enough residual growth and remodeling~     potential.~      ApiFix Ltd has developed a novel implant for less invasive treatment of AIS. The MID-C system~     is designed to correct the deformity step by step along a period of time, giving the skeletal~     and soft tissues time to accommodate any incremental correction.~      The MID-C System inherent benefits are:~        -  Only two screws are used~        -  Incision size is much smaller~        -  Simpler operation with shorter operative time~        -  Less complications (attributed to the three points above).~        -  Minimal spinal mobility loss.~      All the device components are made of materials well accepted in the orthopedic field and are~     fully biocompatible (see Investigator Brochure).~      The unique concept of the system and the materials used may provide favorable results as~     follows: Smaller scare, quicker healing period and better spine mobility over the years.~      This study is designed to demonstrate that the MID-C System is safe and effective.~   "
104444|NCT02200289|"~     Household air pollution from cook stoves using solid fuels dominates total population air~     pollution exposures. Females and young children are disproportionately affected as they~     either perform or are present for the majority of cooking activities. Worldwide, household~     air pollution is responsible for 1.6 million premature deaths annually, largely secondary to~     respiratory tract infections, and 2.7% of worldwide disability-adjusted life years. Children~     that survive childhood are not free from disease; the WHO estimates that 35% of COPD cases~     worldwide are secondary to household air pollution. Reducing female and infant morbidity and~     mortality related to household air pollution secondary to biomass smoke exposure is a~     top-priority public health goal.~      We hypothesize that in utero biomass smoke exposure results in a fetal oxidant imbalance,~     which negatively impacts lung development. We will leverage the success of the Ghana~     Randomized Air Pollution and Health Study, a randomized cook stove intervention trial of~     1,415 mother-infant pairs, to examine the impact of maternal household air pollution exposure~     on cord blood oxidant imbalance and infant pulmonary function. We aim to enroll at least 150~     infants, analyze cord blood samples for markers of oxidant imbalance and perform infant~     pulmonary function testing. Cord blood will also be prepared for future immune, hormonal and~     epigenetic testing. This study will allow us to consider interventions, such as maternal~     antioxidant dietary supplementation during pregnancy, to compliment existing cook stove~     interventions and reduce household air pollution-related morbidity and mortality.~   "
104445|NCT02200276|"~     The immune system is the part of the body that protects against infection. The immune system~     often doesn't work as effectively as people get older. This research is being done to find~     out how the immune systems in older people who are over age 75 respond to influenza vaccine~     (flu shot). We also want to find out if chronic cytomegalovirus (CMV) infection, a common~     virus infection in older persons affects the immune response in people older than 75 years of~     age who receive a flu shot. The Flu Shot is a vaccine approved for the prevention of~     influenza (Flu) infections and is recommended every year for all persons 50 years and~     older. People who are older than 75 years of age are considered healthy or frail may join. A~     total of 525 persons will be participating in this study.~      In order to determine if you are qualified for the study, we would ask you to answer a few~     questions over the phone that will take approximately 5 minutes. If you qualify and agree to~     proceed, you will be asked to come to Johns Hopkins Bayview Medical Center or, if you are~     unable to come to Bayview, one of our staff can visit you at your home. During that visit we~     obtain consent, review your medical history, and measure your vital signs, walking speed and~     grip strength. We will also administer a few brief questionnaires and collect urine and blood~     samples. We will then give you the Flu shot for free. Three to four weeks after you receive~     the Flu shot, you will have another visit at Johns Hopkins Bayview or your home where we will~     repeat some of the questionnaires, vital signs, and collect a second blood sample. Throughout~     the study, we will call you once a week to ask about your general health and any Flu-like~     symptoms. These calls will be made throughout the Flu season which typically lasts through~     the end of May. If you begin to have any influenza like symptoms at any time during the~     study, we ask that you call our office to report these symptoms so that we may perform a~     nasal swab to confirm influenza, and a third blood draw to look at the immune response and~     protection of influenza vaccine.~   "
104446|NCT02200263|"~     The LUVIA study is a randomized placebo-controlled trial designed to investigate the effects~     of lutein and zeaxanthin supplementation on macular pigment and visual function in ocular or~     oculocutaneous albinism. Lutein and zeaxanthin supplementation will be compared to a placebo~     (no treatment) gel pill over the period of 12 months, with study visits approximately every 3~     months for the first year and a final visit 18 months after enrollment.~   "
104447|NCT02200250|"~     Analysis of long term outcomes of patients undergoing endoscopic mucosal resection for~     Barrett's oesophagus with high grade dysplasia and/or early intramucosal carcinoma (IMC).~   "
104448|NCT02200237|"~     This study aims to evaluate the safety, reactogenicity and immunogenicity of EV71 vaccine in~     health children and infants aged from 2 months to <12yrs.~   "
104478|NCT02199847|"~     The general aim of this study is to assess the effects of Pharmaton® Caplets on mental~     performance and physical fatigue in nurses and nursing auxiliaries working night shifts~   "
104711|NCT02196792|"~     The objective of the study is to investigate head penetration, cup migration, and clinical~     outcome in total hip replacements using a factorial design. Treatment groups are E-Poly~     versus ArComXL liners, and 36 mm versus 32 mm head size.~   "
104449|NCT02200224|"~     The purpose of this study is to:~        1. determine the clinical impact of rapid Chlamydia Trachomatis (CT), Neisseria Gonorrhoeae~          (NG) testing on antibiotic over and under treatment for CT/NG in women evaluated in the~          Emergency Department (ED) for a Sexually Transmitted Infection (STI).~        2. determine the clinical impact of rapid Trichomonas Vaginalis (TV) testing on antibiotic~          under and over treatment for TV in women evaluated in the ED for an STI~        3. evaluate the feasibility of integrating rapid Chlamydia Trachomatis (CT), Neisseria~          Gonorrhoeae (NG) and TV testing in the Emergency Department setting.~      To evaluate the impact or rapid CT/NG/TV testing an patient comprehension of Sexually~     Transmitted Infection diagnosis.~   "
104450|NCT02200211|"~     The purpose of the study is to compare the effectiveness of 1 hour/day of binocular game play~     7 days per week with 2 hours/day patching 7 days per week in children 5 to <17~   "
104451|NCT02200198|"~     Malnutrition affects 50% of hospitalized patients around the world and causes changes in~     respiratory muscles predisposing the development of pulmonary complications probable, because~     of the ineffectiveness of cough. How the training of respiratory muscles can improve the~     effectiveness of cough, malnourished patients could benefit from this train however, the~     training of the muscles in malnourished patients has not been tested for safety or~     efficiency. So, the aim of this study is to assess the safety and efficiency of respiratory~     muscle training to improve the potency of cough in malnourished patients.~   "
104452|NCT02200185|"~     The investigators test a different technique using morphine to improve pain relief in patient~     visiting the emergency department with acute trauma pain, for this we are comparing three~     different methods of morphine administration:~        -  intravenous titrated morphine~        -  low dose nebulized morphine and~        -  high dose nebulized morphine~   "
104453|NCT02200172|"~     The purpose of this feasibility study is to inform a larger randomized, placebo-controlled,~     double blind, parallel-group, single-centre trial of an oral, daily administered single dose~     of melatonin to prevent delirium in patients with advanced cancer.~   "
104454|NCT02200159|"~     Research predictive factors of success or failure of a sedation with Dexmedetomidine in ICU~   "
104455|NCT02200146|"~     The aim of the study is determining the non-inferiority in the overall success rate and the~     safety for a combination therapy with hydroxychloroquine plus low dose glucocorticoids~     compared to that for high dose glucocorticoids at 3 and 9 months in patients with pulmonary~     sarcoidosis.~   "
104456|NCT02200133|"~     This randomized study will compare a personalized Survivorship Care Plan (SCP) template with~     usual care (no SCP). The investigators hypothesize that the personalized SCP that~     incorporates patient specific treatment exposures and provides a framework for long term~     followup based on those exposures and subsequent risks for late complications will enhance~     patient survivorship confidence in knowledge, increase adherence to recommended healthcare,~     improve health behaviors and reduce HCT-related emotional distress.~   "
104457|NCT02200120|"~     The purpose of this study is to examine the placement, timing, associated complications,~     efficacy of temporary and tunneled catheters for renal replacement therapy in patient with~     acute kidney injury.~   "
104458|NCT02200107|"~     The purpose of this study is to determine the ability to assimilate and implement an~     integrated treatment program osteoarthritis of the knee, including the diagnosis and~     follow-up by a family physician in primary care clinics, combined with patient self-care~     training and physiotherapy program~   "
104459|NCT02200094|"~     This study is designed to supplement, under conditions of usual clinical practice, the data~     on the efficacy and safety of Micardis® collected during the clinical studies.~   "
104460|NCT02200081|"~     Evaluation of efficacy and safety of MGN1703 administered twice weekly subcutaneously (SC) as~     maintenance treatment in patients with extensive disease small cell lung cancer (SCLC) who~     achieved at least a partial response (PR) following platinum-based first-line therapy.~   "
104461|NCT02200068|"~     Recommendations of Rheumatoid Arthritis management agree on the necessity of patient~     self-involvement in the care. In parallel, the observation of the adoption rate of websites~     directed toward patients may indicate that this involvement is shared by a large number ot~     the population.~      However, most of these sites are only informative and few of them offer patients to be~     engaged to generate their own data that can impact on the patient-physician relationship by~     easing the dialog and then leading to better mutual understanding.~      As new web or mobile services allowing patients to self-report their outcomes are flourishing~     only a very few of them have already addressed the their impact of the patient-physician~     relationship.~      The main objective of this study is to quantify the effect of a website (Sanoia) on the~     quality of patient-doctor interactions, as perceived by the patient using the french~     translations of the Peppi Questionnaire during the 12 months observation period.~      In France, the patient protection committee (CPP) has ranked this study in Soins Courants~     (Usual Care).~   "
104479|NCT02199834|"~     In this project, the investigators hypothesize that in an integrated, multifaceted,~     team-based program incorporating comprehensive assessment with risk stratification, diabetic~     patients with high risk of negative emotions and hospitalization will benefit from additional~     peer support which will improve their psychological health, cardio-metabolic control,~     self-management, quality of life and reduce hospitalization. The investigators further~     hypothesize that peer support will interact with regular personalized feedback reporting to~     improve clinical outcomes.~   "
104480|NCT02199821|"~     Background and Aims: Nutritional support is considered an integral part of the supportive~     care of bone marrow transplantation patients. Parenteral nutrition emulsions enriched with~     omega-3 fatty acids can modify the inflammatory response. The aim of this study is to compare~     plasma cytokines levels in children after bone marrow transplantation using a lipid formula~     enriched in n-3 FA and other classic soybean oil formula in parenteral nutrition.~      Methods: A randomized double blinded controlled study including 14 children with BMT and~     requiring PN for at least 10 days was conducted using a lipid emulsion with fish oil, or~     soybean oil. Blood samples at baseline, at 10 days and at the end of the PN were taken to~     analyze plasma interleukins 1 beta, 2, 6, 8, 10 (IL-10) and tumor necrosis factor alpha~     (TNF-α).~   "
104627|NCT02197884|"~     The purpose of this study is to assess the effects of strong cytochrome P450 (CYP) 3A4~     inhibitors (Itraconazole and Clarithromycin), on pharmacokinetics (PK) (study of the way a~     drug enters and leaves the blood and tissues over time) of single dose of JNJ-54861911 in~     healthy male participants.~   "
104462|NCT02200055|"~     Being able to accurately monitor patient bodily fluid levels during and after surgery is very~     important, as there are a number of complications that can arise if a patient's fluid levels~     become unbalanced, such as swelling within or pressure on various bodily organ systems. There~     are several different ways that physicians can monitor a patient's fluid balance during and~     after surgery, such as measuring the amount of urine output or the use of central venous~     catheters which measure the pressure in the veins entering the heart. Most of these~     techniques are invasive since they require tubes to be inserted into the body. A potential~     alternative would be to use a noninvasive technique such as electrical bioimpedance (BIA).~      Bioimpedance assessments work by using small electrical currents that can accurately predict~     both the water surrounding the outside of cells in the body, as well as the total amount of~     water in the entire body. Electrical bioimpedance assessments have been used to estimate~     patient swelling following surgery (edema), to measure the volume of blood the heart is~     pumping out, as well as to calculate body fat percentages.~      The goal of this study is to relate this technology to fluid shifts within the body that~     occur as a result of surgery, in particular, major intra-abdominal surgeries. By using~     bioimpedance during and after surgery, the investigators will compare the data collected with~     that calculated by using traditional measures of body fluid status, such as urine output and~     intraoperative blood loss. During the study, the bioimpedance monitors will not replace the~     standard bodily fluid monitors and will not interfere with their readings. Additionally, the~     electrical current produced by the bioimpedance monitors is too small for patients to feel~     and will not interfere with medical devices such as pacemakers.~   "
104463|NCT02200042|"~     This randomized phase III trial studies how well gemcitabine hydrochloride and cisplatin with~     or without radiation therapy work in treating patients with localized liver cancer that~     cannot be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride~     and cisplatin, work in different ways to stop the growth of tumor cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. Radiation~     therapy uses high energy x rays to kill tumor cells. It is not yet known whether giving~     gemcitabine hydrochloride and cisplatin is more effective with or without radiation therapy~     in treating patients with localized liver cancer that cannot be removed by surgery.~   "
104464|NCT02200029|"~     A research study of an approved drug called Heptral®, ademetionine, to treat adults with~     intrahepatic cholestasis (a condition where bile cannot flow from the liver to the duodenum)~     in pre-cirrhotic and cirrhotic states. Experience from clinical studies in subjects with~     liver disease has shown that ademetionine is effective.~   "
104465|NCT02200016|"~     Displacement of popliteal sciatic nerve catheters after major foot and ankle surgery. A~     randomized controlled double blinded MRI study comparing long versus short axis catheter~     placement. Which procedure for insertion of nerve catheters for postoperative pain after~     major foot and ankle surgery is the best~   "
104466|NCT02200003|"~     Computer-based attention bias modification treatment (ABMT), which is brief, cost-effective,~     and easy to administer, targets a key mechanism in pathological anxiety - the threat bias, or~     exaggerated attention feared or threatening stimuli. It remains unclear how and for whom ABMT~     is effective, limiting clinical translation. The proposed research involves an RCT using a~     highly sensitive measure of neurocognitive functioning, scalp-recorded event-related~     potentials (ERPs), to delineate key mechanisms of an emerging treatment for anxiety.~     Researchers will recruit 90 anxious participants to engage in the study and pursue the~     following three specific aims: Aim 1 will examine relations between neural and behavioral~     responses to threat prior to ABMT. Aim 2 will examine the effects of ABMT on ERPs to threat,~     threat bias, and anxiety. Aim 3 will examine relations between ERP responses to threat and~     reductions in threat bias and anxiety. Researchers will test whether post-training neural~     changes, specified in Aim 2, are associated with reductions in behavioral threat bias and~     anxiety severity. Researchers will also explore whether ERP measures of greater attention~     capture and/or reduced control of attention to threat at baseline predict treatment response,~     helping identify which patients will benefit most from ABMT. Through the innovative~     combination of a highly sensitive neurocognitive measure and an RCT design, this study aims~     to delineate core neurocognitive responses to threat as mechanisms in the remediation of~     anxiety. Confirmation of study hypotheses would, ultimately, accelerate the pace of~     development of more biologically-informed, accessible, and targeted interventions for~     anxiety.~   "
104467|NCT02199990|"~     Based on China's guangxi guilin for a hernia operation in 1 to 3 years old preschool children~     propofol and etomidate on behavioral and cognitive function after intravenous anesthesia in~     according to beta protein in serum and plasma glutamate (Glutamic acid, Glu) and~     gamma-aminobutyric acid (Gamma aminobutyric acid, GABA) level of observation, the rapid~     development period children's cognitive function after anesthesia short-term and long-term~     change process and its possible mechanism is studied, for the current international debate on~     anesthetics effects on developing kids brain nerve research hot spot in the city of~     clinical basis and research argument, for pediatric anesthesia clinical safety, provide~     theoretical basis for the rational use of drugs.~   "
104481|NCT02199808|"~     Purpose: To examine the effect of the omega-6 to omega-3 fatty acid ratio on age-related~     changes in executive functions in children and older adults.~      Participants: Eighty-four typically-developing 7-to 12-year-old children.~      Procedure (methods): Participants and a caregiver will participate in 4 sessions. Three~     sessions will consist of the screening. These sessions will be telephone calls to collect~     24-hour diet information that will be used to determine whether they are eligible for the~     fourth session. Approximately 120 participants will be screened to find 84 participants who~     are eligible for the fourth session, in which participants will complete a series of tests on~     the Cambridge Neuropsychological Test Automated Battery (CANTAB) - a touch-screen device that~     provides computerized versions of standardized cognitive tests. They will also complete a~     maze task in which they figure out a path through the maze by walking on the correct squares.~     Brain activity will be recorded using a portable near-infrared spectroscopy (NIRS) system.~   "
104558|NCT02198794|"~     The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of~     SD-809 in reducing the severity of abnormal involuntary movements of moderate to severe~     tardive dyskinesia. The purpose of part B is to establish the durability of effect of SD-809~     following one week period of randomized withdrawal (SD-809 and placebo), followed by 12 weeks~     maintenance with SD-809.~   "
104468|NCT02199977|"~     There are compelling medical and public health reasons to reduce unnecessary consumption of~     antimalarials and strong evidence to support the use of RDTs in malaria case management. The~     primary study hypothesis to be tested is that clients who know they will receive a subsidy~     conditional on a positive test are more likely to opt for testing before deciding which drug~     to buy. The primary endpoint is whether subjects choose to be tested for malaria with a rapid~     diagnostic test. The secondary endpoint is whether they purchased an artemisinin combination~     therapy (ACT) or not. The primary outcome of interest is to compare the proportion of~     participants who choose to receive a free malaria diagnostic test when they can receive a~     subsidy for a discounted drug conditional on a positive test (Group A compared to Group B)~     compared to those without the offer of a conditional subsidy. The investigators will use an~     experimental design that randomly assigns clients to one of four groups. Field workers will~     canvas households in the study area looking for individuals who have fever or history of~     fever or illness in the last 24 hours (current illness) who have not yet taken drugs or~     sought treatment outside the home. Clients who meet the inclusion criteria and give verbal~     consent to participate will be randomly assigned to one of the four groups. They will be~     given the location and contact information for their local community health worker who can~     provide a malaria rapid diagnostic test if they choose to be tested. They will also complete~     a survey tool. One week later, the field worker will return to interview the participant and~     determine whether they were tested, what action they took for their illness, what medicine~     they purchased and how much they paid. The investigators will summarize clients' choice by~     the four randomized study groups.~   "
104469|NCT02199964|"~     This study will test that hypothesis that topical administration of the FDA approved~     immunomodulatory agent cyclosporin A emulsion will minimize irritation and ocular surface~     disease that results from a short term low humidity environmental stress~   "
104470|NCT02199951|"~     WHO recommends the use of artemisinin-based combination therapies (ACTs) in the treatment of~     uncomplicated malaria to stem falciparum malaria drug resistance. New ACTs are entering the~     African market and will be used by the public health care system. The collection of safety~     data and risk evaluation through observational data are critical in order to assess~     risk/benefit profile of each ACT through its life cycle and providing information on the best~     use. Additionally there is need to assess the impact of the introduction of a new ACT in the~     evolution of its efficacy and malaria morbidity and mortality. Dihydroartemisinin/Piperaquine~     (DHA/PQP) is a new ACT approved by European Medical Agency and a number of African countries.~     This is a phase IV observational evaluation of the clinical safety of the fixed-dose DHA/PQP~     (Eurartesim®) in public health facilities within selected Health and Demographic Surveillance~     Centres in Burkina Faso (Nouna), Mozambique (Manhica), Ghana (Dodowa, Kintampo, Navrongo),~     Tanzania (Rufiji) and other African countries to be added. Eurartesim® will be used as~     first-line treatment of uncomplicated malaria an objective to evaluate the safety of~     Eurartesim® when used under usual conditions in 10,000 patients. Patients > 6 months and 5 kg~     except pregnant women will be enrolled and Eurartesim® administered as a single daily dose~     regimen over 3 days. Patients will be contacted at Day 5 (± 2 days) after treatment, to~     assess recovery and any adverse events.~   "
104471|NCT02199938|"~     The aim of the study is to improve the understanding of molecular mechanisms in the~     development and progression of musculoskeletal tumors. These tumors do have in general~     unfavorable prognosis and conventional treatments (e.g. surgery, radiotherapy or~     chemotherapy) could not enhance the prognosis of these patients during the last ten to~     fifteen years. Therefore the investigators chose a new way, as they try to identify markers~     on a genetic level, who ideally act as a basis to develop new treatment options.~   "
104472|NCT02199925|"~     If autism is the consequence of a chronic inflammatory process preventing the infant brain~     from forming the proper neural connections, then treatment that reduces inflammation might~     have a positive impact on autism. IGIV treatment has been known to suppress inflammation and~     has been used in the treatment of inflammatory conditions and autoimmune diseases.~   "
104473|NCT02199912|"~     Cachexia associated with cancer is a grave and most of the time irreversible common~     situation. It seems independent from the size of the tumor or from its metastatic character.~     The consequences for the management of the patient are major and exceed widely the frame of~     the nutrition.~      Undernutrition of patients with cancer is described by a decrease of the energy contributions~     and a loss of muscular and fat mass, leading to a progressive functional deficiency which can~     go to the cachectic state.~      Actually, clinical criteria are proposed allowing to characterize the state of pre-cachexia~     but it remain too indistinct to allow an early and efficient screening and set up effective~     measures of prevention of the cachexia, to avoid the loss of muscular tissue and the cast~     iron of the energy reserves.~      It is necessary to have clinical and biological markers with diagnostic aim and forecasts~     during the situations precedents the appearance of cachexia.~      The present study will allow calibrating a longitudinal study, which could confirm the value~     of measures made for the diagnosis of pre-cachexia.~   "
104474|NCT02199899|"~     The objective of the present study is to obtain information about the safety and tolerability~     of BIIF 1149 BS, to determine the pharmacologically active dose (range) by performing a~     citric acid challenge test and to obtain preliminary pharmacokinetic data~   "
104475|NCT02199886|"~     Study to assess the toxicity, pharmacokinetics, biodistribution and imaging characteristics~     associated with increasing doses of 131I-BIBH 1, to compare the uptake of 131I-BIBH 1 in~     tumour to that of normal tissue in patients with non-small cell lung cancer and to measure~     human anti-human antibody (HAHA) concentrations.~   "
104476|NCT02199873|"~     The objective of the present study is to obtain information about the safety and tolerability~     of BIIX 1 XX, to determine the pharmacologically active dose (range) by performing a~     methacholine challenge test and to obtain preliminary pharmacokinetic data~   "
104477|NCT02199860|"~     The purpose of the present study was to obtain information about the safety, tolerability and~     pharmacokinetics of BIBN 4096 BS after single inhalation administration of rising doses of~     spray-dried powder in healthy male and female volunteers. According to the original protocol,~     the primary objective was to investigate the safety and tolerability of single doses of a new~     spray-dried inhalation formulation of BIBN 4096 BS (SD I). Following implementation of~     Amendment 2, this objective was extended to the second spray-dried inhalation formulation SD~     II with and without concomitant administration of lactose~   "
104482|NCT02199795|"~     This is a small pilot randomized controlled trial which will enroll both subacute (<6 mos)~     and chronic (>6 mos) stroke survivors with ankle dorsiflexion weakness. The subjects will be~     randomized to Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES) versus~     control. The primary objective of this study is to compare the effect of 6-weeks of lower~     extremity CCNMES, applied in an anti-phase application, on motor impairment and functional~     mobility to a control group.~   "
104483|NCT02199782|"~     19% of Wales' population speaks Welsh. Under the Welsh Language Act 1993, every public body~     providing services to the public in Wales has to prepare a scheme setting out how it will~     provide those services in Welsh.~      Diagnosing dementia requires a comprehensive assessment, an essential component of which is a~     cognitive assessment tool, which takes the form of a questionnaire. In clinical practice,~     this is currently only available through the medium of English.~      The investigators objective is to measure the difference between Cognitive Assessment scores~     (using the Montreal cognitive assessment (MoCA)), when done in English and Welsh, in those~     who are cognitively impaired and whose first language is Welsh. The investigators predict~     that there will be a significant difference in scores in favour of the Welsh-medium tests,~     thus proving that the current mode of administering the test is prejudiced against patients~     whose first language is Welsh.~      If the investigators predictions are correct, then the investigators would seek to introduce~     a validated Welsh-language cognitive assessment tool to the domain of the Welsh NHS.~   "
104484|NCT02199769|"~     This study will focus on the cohort of 20,000 established patients cared for by 31 attending~     physicians in the outpatient, adult primary care practices at UT Southwestern (two general~     internal medicine one family medicine and one geriatric practice). The investigators will~     develop and implement an automated Diabetes Detection Tool (DDT) that does data mining on~     electronic medical record (EMR) lab data to systematically identify all primary care patients~     with elevated random plasma glucose results (RPGs) who are at high risk of diabetes and thus~     in need of further testing. In a cluster-randomized trial, primary care providers will be~     randomized to either the intervention/DDT arm or usual care. Providers in the intervention~     arm will receive visit-based, EMR-enabled case identification and real-time decision support.~     Outcomes will be tracked at a patient level. All subjects will be followed for 12 months to~     assess rates of follow-up diabetes testing, time to testing, rates of subsequent diabetes~     diagnosis, and time to diagnosis. The investigators hypothesize that the visit-based provider~     decision support will be superior to usual care.~   "
104485|NCT02199756|"~     The purpose of the study is to find out whether indomethacin encapsulated within a nanovector~     can stop contractions in pregnant human uterine tissue. Preterm delivery is a major~     contributor to newborn deaths. The treatment of preterm labor includes medications that stop~     contractions within the uterus, or womb. Indomethacin is effective in stopping uterine~     contractions, but crosses the placenta to the unborn baby causing problems for the baby.~     Nanovectors are used to direct the delivery of medications. If indomethacin can be delivered~     directly to the uterus using a nanovector, it may be an ideal medication to treat preterm~     labor. We hypothesize that nanovectors loaded with indomethacin will reduce uterine~     contractions.~   "
104486|NCT02199743|"~     24 individuals with schizophrenia or schizoaffective disorders, who are currently considered~     stable, will be recruited, screened for entry criteria into a blinded study with a 4-week~     randomization to either lurasidone, haloperidol, or perphenazine to examine glutamate-related~     outcomes with lurasidone as compared to haloperidol and perphenazine.~   "
104487|NCT02199717|"~     This pilot project was developed to investigate subjective and objective data related to the~     patterns of physical activity participation among hemophilia patients (FVIII or FIX) between~     the ages of 5 and 18 years. Physical activity participation among different levels of disease~     severity will be compared using accelerometers to calculate the amount of time spent in~     moderate to vigorous physical activity (MVPA) and the number of bouts of MVPA; additionally,~     data will be collected from two validated questionnaires (PedHAL and 3 day physical activity~     recall). Current literature that relates level of physical activity to disease severity in~     the pediatric hemophilia population is limited. The information gained about the type and~     quantity of physical activity participation in children with varying levels of hemophilia~     will assist in the development of education and interventions to promote good physical~     activity and potentially examine the role of tailored prophylaxis.~   "
104488|NCT02199704|"~     The aim of the case series study is to explore if a self directed version of the Positive~     Parenting Program (Triple P) is a feasible and acceptable intervention for individuals with~     psychosis who are parents.~   "
104489|NCT02199691|"~     The purpose of this trial is to evaluate the immunogenicity and safety of MenACYW conjugate~     vaccine compared to those of a licensed product, MENVEO vaccine and also evaluate MenACYW~     conjugate vaccine when given alone compared to when given with Tdap vaccine and HPV vaccine.~      Primary objective:~        -  To evaluate the antibody responses to the antigens present in MenACYW conjugate vaccine~          when MenACYW conjugate vaccine is given alone compared to those when MENVEO vaccine is~          given alone.~      Secondary objective:~        -  To evaluate the antibody responses to the antigens present in MenACYW conjugate vaccine,~          when MenACYW conjugate vaccine is given concomitantly with Tdap and HPV vaccines,~          compared to those when it is given alone~        -  To evaluate the antibody responses to the antigens present in Tdap vaccine, when Tdap~          vaccine is given concomitantly with MenACYW conjugate vaccine and HPV vaccine, compared~          to those when Tdap vaccine is given with HPV vaccine only~      Observational objective:~        -  To describe the safety profile of MenACYW conjugate vaccine, compared to that of the~          licensed vaccine MENVEO®, and when MenACYW conjugate vaccine is given with Tdap and HPV~          vaccines.~   "
104490|NCT02199678|"~     This is a Phase 2, randomized, multicenter, parallel group, double-blind, dose-ranging,~     placebo-controlled evaluation of the analgesic efficacy, safety and pharmacokinetics of~     ketamine sublingual wafer in adult subjects who experience post operative pain after~     undergoing third molar extraction.~   "
104502|NCT02199522|"~     As we know propofol is popular use in the anesthesia induction with kilogram and it always~     cause hypotension. So we compare haemodynamic changes and drug consumption between propofol~     titrated administration and traditional administration for anesthesia induction.~   "
104652|NCT02197559|"~     The study hypothesizes that Drug -eluting stents are more effective in preventing restenosis~     than Bare-metal stents after Vertebral Artery Ostium stenting~   "
104491|NCT02199665|"~     This phase I trial studies the side effects and best dose of selinexor and carfilzomib when~     given together with dexamethasone in treating patients with multiple myeloma that has~     returned or does not respond to treatment. Drugs used in chemotherapy, such as selinexor and~     dexamethasone, work in different ways to stop the growth of cancer cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. Carfilzomib~     may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~     Giving selinexor, carfilzomib, and dexamethasone may be a better treatment for multiple~     myeloma.~   "
104492|NCT02199652|"~     Patients with PTSD, and frequent nightmares, and mild-moderate suicidal ideation, who are~     already taking a Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin Norepinephrine~     Reuptake Inhibitor (SNRI) will be randomized to either prazosin or placebo. The investigators~     hypothesize that patients receiving prazosin will have a greater reduction in suicidal~     ideation.~   "
104493|NCT02199639|"~     Multidisciplinary evaluation of patients with hemophilia Spain, El Salvador and Bolivia. It~     aims to analyze and evaluate the skeletal muscle of patients affected with hemophilia Spain,~     El Salvador and Bolivia; describe deficit mobility and muscular strength, depending on the~     degree of injury, age, presence of inhibitors and the development of physical activity;~     identify the relationship between the functional deficit by clinical assessment performed~     with the use of validated measurement scales, the assessment of the degree of injury to~     specific scales of hemophilia; detect biomechanical alterations of the lower limbs and their~     impact on gait in patients with hemophilia; and evaluate the factors that influence the~     perception of illness and quality of life of patients with hemophilia.~   "
104494|NCT02199626|"~     This prospective pilot study of 40 pediatric patients with Crohn's Disease, that are~     candidates for endoscopic and imaging re-evaluation, examines the Given Diagnostic System and~     the second generation of colon capsule in comparison second generation of colon capsule~     endoscopy (CCE-2) to magnetic resonance enterography (MRE), small intestine contrast~     ultrasonography (SICUS) and endoscopy (upper and lower).~      This study aims~        1. To evaluate and compare the accuracy of CCE-2 with MRE, SICUS and endoscopy in the~          evaluation of pediatric Crohn's disease.~        2. To evaluate the safety of CCE-2 in pediatric CD.~   "
104495|NCT02199613|"~     The study aims to assess the safety and efficacy of darunavir 800mg plus the co-formulated~     elvitegravir/cobicistat/tenofovir disoproxil fumarate (DF)/emtricitabine (Stribild) tablet as~     a simplification strategy for the treatment of HIV infection in HIV-infected subjects who~     have had previous antiretroviral treatment experience with multiple-drug regimens.~      We hypothesize that elvitegravir/cobicistat/tenofovir DF/emtricitabine with darunavir will~     offer a safe and efficacious treatment simplification strategy for HIV positive patients~     currently receiving multiple-drug regimens to control their HIV infection.~   "
104496|NCT02199600|"~     This is a Post-Marketing Surveillance of GMK Sphere knee prosthesis.~   "
104497|NCT02199587|"~     The investigators would like to examine the contribution of medical clowns in routine medical~     procedures in the endocrine clinic. This will be the first time that will objective evaluate~     the effect of medical clown on stress hormone such as adrenaline cortisol and prolactin, and~     also evaluate the effect of mental stress on growth hormone secretion in children.~      The aim of the current study is testing the pain and anxiety of the patient and the~     accompanying parent and medical staff in the presence or absence of medical clown at the~     time:~        1. LRH analog (decapeptyl) intramuscular injections for precocious puberty.~        2. Growth hormone tests.~      Secondary end point will be:~        1. Changes in stress hormones: cortisol , prolactin and adrenalin during growth hormone~          tests in the presence of a clown.~        2. Does the presence of a medical clown and the mental stress affect the secretion of~          growth hormone?~        3. Are there differences in growth hormone secretion and stress hormones between the~          various tests for growth hormone secretion (glucagon, clonidine or arginine) in the~          presence of a clown?~        4. Are there differences in response to stress and the secretion of growth hormone in~          children with obesity?~   "
104498|NCT02199574|"~     The purpose of this study is to characterize the pharmacokinetic (PK) profile of a single~     dose of EXPAREL (133 mg/10 mL) administered intraoperatively per normal infiltration for~     prolonged analgesia in 12 adult subjects undergoing tonsillectomy with or without removal of~     the adenoids.~   "
104499|NCT02199561|"~     Manipulation of the intestinal microbiota through FMT is a potential therapeutic target for~     CD patients. Studies are now required to determine if repeated FMT can overcome the apparent~     immune response to FMT thereby maintaining sustained clinical improvement and remission.~     Prior to a large randomized controlled trial of FMT in CD we will carry out a feasibility~     study to determine if serial FMTs can sustain a clinical response and maintain stability of~     transplanted microbiota.~   "
104500|NCT02199548|"~     Adolescents with cancer weigh multiple influences in medical decision-making, including their~     own best interest, the perceived wishes of family members, and the interpreted preferences of~     the health care team. Parents of children with cancer often describe themselves as trying to~     be a good parent in making decisions in the child's best interest. Adolescents with cancer~     often describe themselves as trying to be a good patient and good child in making decisions~     in accord with how they believe a good patient and good child would decide.~      Among the challenges of caring for adolescents is the reality that the formative relational~     influences in adolescents' decision-making are both complex and unique due to adolescent~     patients' social networks and relational roles. Delineating adolescents' definitions of being~     a good patient, a good child, a good sibling, and a good friend may enable the care team to~     better understand the formative decisional influences relevant to adolescents with cancer.~     Expanding knowledge about the decision making constructs relevant to adolescents with cancer~     and recognizing the role of these social constructs in medical interactions has the potential~     for development of a comprehensive care model that methodically evaluates the self-assessed~     decision making influences and needs of adolescents at various stages in oncology care.~      This qualitative construct-defining study represents an initial step in the development of~     enhanced interventions for improved psychosocial support in this vulnerable population.~   "
104501|NCT02199535|"~     The aim of the study was to investigate the analysis of the risks faced by the personnel~     working in the field of Anesthesiology and Reanimation in Turkey~   "
104503|NCT02199509|"~     Background:~      - People with dystonia cannot control their muscle contractions. This disorder can affect~     different body areas. When it affects the face, tongue, and jaw, it is called oromandibular~     dystonia (OMD) or cranial dystonia (CD). Researchers want to find out if a drug that treats~     seizures may help people with this kind of dystonia.~      Objective:~      - To see if levetiracetam can improve symptoms of jaw or face dystonia.~      Eligibility:~      - Adults ages 18 to 80 years with OMD or CD.~      Design:~        -  Participants will be screened with a medical history and physical exam. Researchers will~          test how severe their dystonia is.~        -  Participants will have blood drawn through a needle in the arm.~        -  Participants will be assigned to take either levetiracetam or placebo.~        -  Phase 1:~        -  Participants will start with one 500-mg tablet twice daily. The dose will be increased~          by 500 mg every 3 days. The maximum dose will be 4000 mg a day over 3 weeks.~          Participants who cannot tolerate that will take the highest dose they can.~        -  Participants will return for study visits at weeks 3 and 6. They will be asked about~          their health, side effects, and symptoms of depression. They will have a neurological~          examination and test of their dystonia.~        -  After the week 6 visit, participants will taper and stop the study drug over about 1~          week.~        -  Phase 2 begins one week later. Participants will repeat phase 1, but with the other~          drug.~        -  After phase 2, participants will return to their usual clinics. They will be told how to~          stop taking the drug. They will have a follow-up phone call 2 weeks later.~   "
104504|NCT02199496|"~     Background:~      - Some people with Common Variable Immunodeficiency Disease (CVID) have gastrointestinal~     inflammation. This can cause diarrhea, weight loss, and not being able to absorb nutrition~     from food. Researchers want to see if the drug ustekinumab can help these problems. This drug~     blocks some proteins that cause inflammation.~      Objective:~      - To test the safety and efficacy of the drug ustekinumab for people with CVID with~     gastrointestinal inflammation.~      Eligibility:~      - Adults ages 18-75 with CVID. They must have chronic diarrhea, have unintentionally lost~     weight in the last year, and/or need to use nutritional supplements to maintain their weight.~      Design:~      Participants will undergo the following screening studies to make sure that this study is a~     good fit for your medical situation, and to make sure it is safe for you to receive the study~     medications tests, including tests for HIV and hepatitis . This will be done as an inpatient~     at the NIH Clinical Center and takes about 5-6 days:~        -  Participants will be screened with:~        -  Medical history~        -  Physical exam~        -  Blood tests, including tests for HIV and hepatitis.~        -  Stool tests, including a timed 48 hour collection for fat malabsorption and a 24 hour~          collection for protein malabsorption~        -  Urine tests, including a pregnancy test for any women with the ability to have a child~        -  Chest CT scan to look for infection~        -  D-xylose testing, which involves drinking a sugary solution and then having a blood~          sample drawn to test carbohydrate (sugar) malabsorption~        -  Hydrogen breath testing for test for small intestinal bacterial overgrowth (SIBO) this~          test also involves drinking a sugary solution and then collecting breath samples~        -  Upper endoscopy (EGD) and/or colonoscopy to look at the lining of the GI tract and take~          biopsies for testing. This will be done under sedation by a qualified~          gastroenterologist.~      Participants who complete screening and meet all criteria will then return to the NIH~     Clinical Center for the following visits:~        -  First Treatment Visit (1 clinic day): Medical history, physical exam, measurement of~          vital signs and weight, review of medications, and an assessment of number and~          consistency of stools each day. A pregnancy test for women of childbearing potential. A~          nurse will give you three shots of 90 mg ustekinumab (270 mg total dose) by very small~          needles injected under the skin, and then observe you for 1 hour.~        -  Week 8 Treatment Visit (1 clinic day): Medical history, physical exam, measurement of~          vital signs and weight, review of medications, and an assessment of number and~          consistency of stools each day. Blood, urine and stool samples will be collected. A~          pregnancy test for women of childbearing potential. A nurse will give you one 90 mg dose~          of ustekinumab by a very small needle injected under the skin, and then observe you for~          1 hour.~        -  Week 16 Treatment Visit (1 clinic day): Medical history, physical exam, measurement of~          vital signs and weight, review of medications, and an assessment of number and~          consistency of stools each day. Blood, urine and stool samples will be collected. A~          pregnancy test for women of childbearing potential. A nurse will give you one 90 mg dose~          of ustekinumab by a very small needle injected under the skin, and then observe you for~          1 hour.~        -  Week 24 Treatment and Mid-point Evaluation Visit (4-6 inpatient days): Medical history,~          physical exam, measurement of vital signs and weight, review of medications, and an~          assessment of number and consistency of stools each day. Blood, urine and stool samples~          will be collected, including repeating the d-xylose carbohydrate malabsorption testing,~          the 24 hour stool collection for protein malabsorption and the 48 hour stool collection~          for fat malabsorption. A pregnancy test for women of childbearing potential. A nurse~          will give you one 90 mg dose of ustekinumab by a very small needle injected under the~          skin, and then observe you for 1 hour.~        -  Week 32 Treatment Visit: Medical history, physical exam, measurement of vital signs and~          weight, review of medications, and an assessment of number and consistency of stools~          each day. Blood, urine and stool samples will be collected. A pregnancy test for women~          of childbearing potential. A nurse will give you one 90 mg dose of ustekinumab by a very~          small needle injected under the skin, and then observe you for 1 hour.~        -  Week 40 Treatment Visit: Medical history, physical exam, measurement of vital signs and~          weight, review of medications, and an assessment of number and consistency of stools~          each day. Blood, urine and stool samples will be collected. A pregnancy test for women~          of childbearing potential. A nurse will give you one 90 mg dose of ustekinumab by a very~          small needle injected under the skin, and then observe you for 1 hour.~        -  Week 48 ...~   "
104505|NCT02199483|"~     Background:~      - Many people can lose weight by changing their diet or exercise. However, most people~     eventually regain the weight over time. This weight regain may be related to changes in~     metabolism as well as changes in the brain caused by weight loss. Researchers want to learn~     more about these changes.~      Objective:~      - To see how weight loss and regain affects the body s metabolism and the brain of obese but~     healthy adults.~      Eligibility:~      - Obese but healthy adults age 18-55 who plan to participate in a weight loss program at one~     of several participating clinics or resorts.~      Design:~        -  Participants will first be screened at home through questionnaires and telephone~          interviews.~        -  Participants will then be screened at the NIH with blood tests, medical history,~          physical exam, electrocardiograms, and questionnaires. They will have a mock magnetic~          resonance imaging (MRI) scan.~        -  At visit 1, participants will stay at the NIH and will:~        -  have MRI and PET brain scans.~        -  have body composition scans and measurements.~        -  give blood samples.~        -  eat a special diet.~        -  wear a physical activity monitor.~        -  provide a urine sample and body weight daily.~        -  drink a special type of water to measure calorie burn.~        -  wear a clear plastic hood over their head while lying down, to collect exhaled air.~        -  spend 24 hours in a room that measures oxygen and carbon dioxide.~        -  complete questionnaires and computer tasks.~        -  After visit 1, participants will give daily urine samples and weight and physical~          activity measurements from home. Then they will follow a lifestyle intervention for~          weight loss and give daily weight and activity measurements.~        -  Visits 2, 3, and 4 occur 1-26 months after the start of the weight loss program.~          Participants will repeat procedures from visit 1. Visits 1-4 last 4 days each.~        -  Researchers will track participants weight and physical activity for up to 26 months~          after visit 2.~   "
104506|NCT02199470|"~     Enhancing endogenous insulin production in type 1 diabetic patients (T1DP) can improve~     glycemic control and decrease complications and rates of mortality. However, it can be~     succesfull even if sufficient β-cell function is present. We aimed to evaluate the extent of~     β-cell function by determining fasting levels of C-peptide and those after meal stimulus.~   "
104507|NCT02199457|"~     A medical device study to assess the clinical accuracy and equivalence to reference devices~     of the SVSS to satisfy the requirements of the recognised applicable international standards.~   "
104508|NCT02199444|"~     The accumulation of p-cresol, a product of the metabolism of aromatic aminoacid operated by~     resident intestinal bacteria increases the cardiovascular risk of chronic kidney disease~     (CKD) patients. Therefore, therapeutic strategies to reduce plasma p-cresol levels are highly~     demanded. It has been reported that the phosphate binder sevelamer sequesters p-cresol in~     vitro, while in vivo studies on dialysis patients showed controversial results. Aim of our~     study was to evaluate the effect of sevelamer on p-cresol levels in CKD patients.~   "
104509|NCT02199431|"~     The purpose of this study is to evaluate the increase in exposure of Lu AF11167 following a~     single oral dose of Lu AF11167 with and without administration of multiple oral doses of~     itraconazole (a strong CYP3A4/5 inhibitor) in healthy subjects with inferred metabolic status~     as CYP2C19 extensive metabolisers~   "
104510|NCT02199418|"~     The investigators hypotheses that paclitaxel combined with cisplatin in a weekly-based~     regimen as neoadjuvant chemotherapy is effective and tolerable for locally advanced breast~     cancer.~   "
104541|NCT02199015|"~     The aim of our work is to investigate whether electrical Lateral Cord Stimulation (LCS)~     causes an inhibitory and modulatory action by indirect cerebellar activation, so releasing~     spasticity and the spastic syndrome in selected cases of patients with cerebral palsy~   "
104583|NCT02198469|"~     Methyl aminolaevulinate photodynamic therapy (MAL-PDT) is advantageous in that it has few~     cosmetic side effects and minimises patient discomfort. However, its relatively low efficacy~     prevents its application to the treatment of actinic cheilitis(AC). Er:YAG ablative~     fractional laser (AFL) treatment removes the stratum corneum to increase MAL uptake and may~     improve efficacy. However, no studies have directly compared the efficacy of MAL-PDT with and~     without Er:YAG AFL in treating AC~   "
104511|NCT02199405|"~     The incidence of cervical spondylosis on young people is increasing every year. Suffering~     from this disease will affect the normal life and learning of young people. Episode younger~     and incidence higher of this disease could increase health care spending of the government in~     the economy. Cervical spondylosis of cervical type is the main type of cervical spondylosis~     of young people. Patients of cervical spondylosis of cervical type always manifest the head,~     neck and shoulder pain accompanied by corresponding pressure point, the X-ray display of~     Upper cervical curvature change and instability of intervertebral joint performance ,and the~     dynamic lateral X-ray shows vertebral instability or trapezoidal change. The conservative~     treatment is the primary and preferred treatment of the disease.~      This study is designed as a random, control, single blind study. It will recruit 140 cases of~     cervical spondylosis of cervical type. Both the treatment group and the control group will be~     randomly assigned 70 cases. Patients in the treatment group will be treated by Massage of~     chiropractic and adjusting cervical curvature and practice Sishi Daoyin for 4 weeks，and the~     control group by conventional massage and cervical traction. The total study includes 2 views~     that are baseline and post-4week intervention. At all of the 2 views, all participants will~     be examined range of motion of cervical vertebra, cervical curvature, and Surface~     Electromyography of neck muscles, and will be estimated scores of The Neck Disability~     Index(NDI), the Northwick Park Neck Pain Questionnaire (NPQ),Short-form McGill Pain~     Questionnaire(SF-MPQ) and Evaluation of the therapeutic effect. This study aims to~     investigate the efficacy of Massage of chiropractic and adjusting cervical curvature and~     Sishi Daoyin practice, and discover the correlation between these scales and these objective~     indicators to discover the indicators of early warning signs of cervical spondylosis of~     cervical type of young people.~   "
104512|NCT02199392|"~     The purpose of this single-dose, open-label, sequential, three-period study in 15 healthy~     subjects was to assess the influence of P-glycoprotein inhibition and simultaneous CYP3A4 and~     P-glycoprotein induction on lenvatinib pharmacokinetics following single dose oral~     administration of 24 mg lenvatinib to healthy volunteers.~   "
104513|NCT02199379|"~     The purpose of this multicenter, open-label, non-randomized, single, oral dose,~     sequential-cohort study was to determine pharmacokinetics and safety of lenvatinib (24 mg)~     administered to healthy subjects and to subjects with renal impairment.~   "
104514|NCT02199366|"~     This is a pilot study to determine if there are changes in heart function following~     completion of radiation therapy for breast cancer as measured by cardiac magnetic resonance~     imaging (cardiac MRI) scans. Additional purposes of this study are to assess cardiac side~     effects from radiation treatment, evaluate cardiac MRI changes by radiation technique, and~     compare quality of life questionnaires.~   "
104515|NCT02199353|"~     To assess the effectiveness of the Stimulation of Activities of Daily Living (SADL)~     Occupational Therapy programme on the independence of ADL by persons with dementia who are~     institutionalized. This programme is based on the recovery of the cognitive functions.~   "
104516|NCT02199340|"~     The progression of lung disease in cystic fibrosis (CF) results inevitably in a reduction in~     exercise capacity. The assessment of fitness and exercise capacity in CF is an important~     measure of the impact of the disease process, particularly if it is repeated over time. With~     recent advances in clinical management, CF lung disease in children can be relatively mild~     and exercise tolerance good. The currently available field tests e.g. 3 minute step test, are~     often completed too easily. These tests provide limited information relating to maximal~     exercise performance. By contrast, the maximal CardioPulmonary Exercise Test (CPET), a~     progressive, incremental, gold standard exercise test with breath by breath analysis of~     expired gas, has proved to be a valuable means of assessing exercise response in patients~     with CF. Its only limitation is the requirement for specialist laboratory facilities,~     equipment and staff.~      A new field test for evaluating exercise capacity in children is needed. This should be~     portable, easy to administer and simple to perform by young children, while providing a~     higher intensity of exercise which correlates with day to day activity patterns of children,~     and clinically relevant information in the short term and longitudinally. This test needs to~     be a good surrogate measure of exercise capacity when formal CPET is unable to be undertaken.~     By providing accurate and useful information the results can be used to prescribe and train~     individuals with CF safely and effectively and can also be used in the short and long term~     for guidance of the medical management of these complex patients.~      The aim of this study is to develop and validate the use of a new incremental step test to~     assess exercise tolerance/capacity in children with CF, compare this with the gold standard~     CPET and to provide normative healthy control comparison data The main objectives of the~     study are~        1. To develop an incremental step test to assess exercise tolerance / capacity in children~          with CF.~        2. To compare the incremental step test with the gold standard CPET~        3. To assess the level of exercise response produced by the incremental step test~        4. To assess the correlation between independent variables of lung function measurements,~          age, weight and height with VO2peak and other exercise test outcomes~        5. To assess the repeatability and evaluate the normal variability of the new incremental~          step test~        6. To provide healthy control normative data for comparison~   "
104517|NCT02199327|"~     The purpose of this study is to evaluate the therapeutic efficacy of interferon alfa 2b and~     topical mitomycin C in patients with diagnosis of conjunctival-corneal intraepithelial~     neoplasia.~   "
104518|NCT02199314|"~     Test the hypothesis to recruit larger motor responses to transcranial stimulation.~   "
104519|NCT02199301|"~     Kidney transplantation (KT) requires a life-long immune suppression (IS). It has been~     well-known that long-term IS inevitably causes various complication e.g. infection, toxicity,~     diabetes, osteoporosis, avascular necrosis of hip joint, cataract, acne, and malignancies and~     so on. Tolerance induction showing graft function without maintenance IS has been considered~     as a final solution in the transplantation recipients. Tolerance induction can be achieved in~     KT recipients with donor hematopoietic stem cell transplantation (HSCT).~      In this study, adult patients (18 and more years of age) with a human leukocyte antigen~     (HLA)-haplotype match donor are enrolled. Patients receive preconditioning treatment for HSCT~     1week prior to KT. Bone marrow is harvested from donor under general anesthesia at the time~     of nephrectomy for transplantation in donor. Donor BM is infused immediate~     post-transplantation at intensive care unit (ICU). Immunologic measurements including~     microchimerism study and protocol biopsy will be followed at several time points. IS will be~     tapered slowly and withdrawn over a period of several months.~   "
104520|NCT02199288|"~     This prospective, open-label, multicenter, observational study will investigate the~     effectiveness and safety of MabThera SC (rituximab, subcutaneous) induction therapy in~     patients with non-Hodgkin's lymphoma, following a first initial treatment of MabThera IV~     (rituximab, intraveneous). Induction treatment period in the study is estimated to be 8~     months.~   "
104521|NCT02199275|"~     During non urgent surgery, general anesthesia might induce enterocyte damage. I-FABP is a~     performant biomarker of enterocyte damage. We aimed to study whether patient ongoing general~     anesthesia for non-urgent surgery have an elevation of plasma I-FABP concentration.~   "
104542|NCT02199002|"~     Gastroesophageal reflux disease (GERD) is a very common condition affecting up to 30% of~     adults. To date, therapy consists of powerful acid suppression with proton pump inhibitors~     (PPI). Nevertheless, only 60-70% of GERD patients report complete symptom relief with this~     therapy. As the mechanisms underlying symptom perception in PPI resistant patients are not~     fully understood, there is currently no adequate therapy available.~      It is becoming increasingly clear that reflux, especially in the postprandial period, occurs~     from a reservoir of acid floating on top of the meal: the so-called acid pocket. In this~     study, we aim to investigate further the acid pocket by determining its exact position and~     chemical contents between healthy volunteers, GERD patient who respond well and bad to PPI~     therapy and GERD patients with barrett's esophagus.~   "
125824|NCT01920542|"~     we hypothized dexmedetomidine could reduce the reduction of renal function after~     cardiopulmonary bypass weaning in pediatric patients~   "
104522|NCT02199262|"~     Agitation in the intensive care unit can have multiple consequences. The investigators~     hypothesize that agitation and its consequences can be reduced by the introduction of a~     reminder aiming at guiding the management of agitation. The investigators also hypothesize~     that they can prevent agitation and its consequences by acting on patients environment with~     reafferentation and relaxation methods.~      The investigators' objectives are to test within a quality improvement project by a~     prospective randomized study:~        -  If by reducing the number of agitation episodes we reduce the number of harmful~          consequences.~        -  If the introduction of reafferentation and relaxation methods (music therapy or~          reflexology) can prevent the occurrence of agitation.~        -  If the introduction of a reminder on management of agitation can reduce the number of~          agitation episodes.~      This study is conducted in an18 general surgical ICU beds receiving 1600 patients / year for~     a total of 6900 hospital /days /year, in a tertiary teaching hospital.~      The study is organized in 3 phases:~        1. First phase: Baseline phase (Prospective analysis of the present situation)~        2. Second phase: Learning phase (Implementation of a reminder about the management of~          agitation and delirium )~        3. Third phase: Randomized Intervention (reminder alone vs addition of music or~          reflexology)~      The interventions are :~        1. Implementation of a reminder of guidelines of agitation diagnosis and management.~        2. Music intervention( see description below) + reminder~        3. Reflexology (see description below)+ reminder~      Agitation is monitored with two scales SAS and CAM-ICU(description below) . Harmful~     consequences and complications are systematically registered as well as medication and the~     use of contention methods.~      Adherence to the implemented monitoring and interventions is also regularly checked.~      Data are daily collected (see details below) Statistical analysis and power calculation (see~     below)~   "
104523|NCT02199249|"~     Tibia-fibular syndesmosis injury occurs in a significant proportion of ankle injuries and is~     assumed to disrupt the syndesmotic ligaments.~      The goal of operative treatment is to reduce the ankle mortise to restore normal joint~     kinematics. Syndesmosis repair can be performed using either open or closed reduction,~     combined with fixation between the distal tibia and fibula. Closed fixation has demonstrated~     high rates of non anatomic reductions greater than 40%; therefore, open reduction will be~     performed in this study. Screw fixation is stable but concerns exist regarding potential~     excess rigidity.~      Recently, flexible fixation techniques combined with anatomic reduction have demonstrated~     improvements in functional outcomes and reduction quality. Both open reduction and flexible~     TightRope fixation have considerable support in the literature in cohort studies but have not~     been compared to open screw fixation in a randomized controlled trial.~      In this multi centre randomized study, radiographic, economic and functional outcomes are~     compared between [open reduction, flexible Tightrope syndesmosis fixation (OT)] and [open~     reduction screw fixation (OS)] of the syndesmosis.~   "
104524|NCT02199236|"~     The purpose of this study is to see what amount of radiation is safe to give to rectal or~     anal cancer patients who are being treated with a procedure called brachytherapy.~   "
104525|NCT02199223|"~     Evaluate the safety of regorafenib and panitumumab~   "
104526|NCT02199210|"~     The purpose of the project is to investigate the function of self-regulatory processes in~     anesthesiologists and how application of these processes influence performance in a crisis~     situation.The investigators intend to explore specifically the first phase of~     self-regulation, i.e. the forethought phase which describes processes related to strategic~     planning, goal setting, goal orientation, and outcome expectation. The investigators~     hypothesize that prompting forethought before engaging in a simulated massive transfusion~     crisis situation will result in better task performance in anesthesiologists.~   "
104527|NCT02199197|"~     Study of Radium Ra 223 dichloride with enzalutamide compared to enzalutamide alone in men~     with metastatic castration refractory prostate cancer~   "
104528|NCT02199184|"~     Any time the words you, your, I, or me appear, it is meant to apply to the potential~     participant.~      The goal of this clinical research study is to learn if adding ofatumumab/rituximab to the~     standard combination of DA-EPOCH (dose-adjusted etoposide, prednisone, vincristine, and~     cyclophosphamide) can help control the disease in patients with newly diagnosed or~     relapsed/refractory Burkitt leukemia or relapsed/refractory ALL. The safety of this drug~     combination will also be studied.~      This is an investigational study. DA-EPOCH is commercially available and FDA-approved for the~     treatment of Burkitt leukemia and ALL. Ofatumumab and rituximab are commercially available~     and FDA-approved for the treatment of some types of chronic lymphocytic leukemia (CLL). It is~     considered investigational to add ofatumumab to DA-EPOCH to treat Burkitt leukemia and ALL.~     The study doctor can explain how the study drugs are designed to work.~      Up to 40 participants will be enrolled in this study. All will take part at MD Anderson.~   "
104529|NCT02199171|"~     This phase I trial studies the side effects and best dose of heated carboplatin given into~     the abdomen at the time of surgery in treating patients with stage II-IV ovarian, fallopian~     tube, or peritoneal cancer. Drugs used in chemotherapy, such as carboplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Heating oxaliplatin and infusing it~     directly into the area around the tumor during surgery may kill more tumor cells.~   "
104530|NCT02199158|"~     Purpose:~      To evaluate short-term angle opening after argon peripheral iridoplasty using AS-OCT and to~     report its complications at 1-week and 1-month follow up in patients that did not achieve a~     satisfactory clinical angle opening despite patent laser peripheral iridotomy.~      Design:~      Prospective, Interventional case series~      Subjects:~      Patients with an occludable angle in more than two quadrants in dark room indentation~     gonioscopy and patent iridotomies of at least 2 weeks, with assessment of persistent angle~     closure aetiology by ultrabiomicroscopy and A-scan ultrasound are included.~      Patients will undergo complete examination and AS-OCT before ALPI, one week and one month~     after it. We analyzed the images in a masked manner and took the angle measurements (AOD500,~     AOD 750, TISA500, TISA750, ARA500, ARA 750, Lens vault) at 0° and 180° as the main outcome~     measure to determine effectiveness.~   "
104543|NCT02198989|"~     40 patients with Type 2 Diabetes Mellitus who also have sleep disorders and mild depression~     in the community will be recruited and stochastically divided into the intervention group and~     the control group. Both groups will take the same group education courses including DSME~     (Diabetes Self-management Education), psychological support, improvement in sleep. Patients~     in the intervention group will receive peer support and yoga music therapy before bed. The~     observation period will last for 6 months so as to evaluate the benefits of peer support and~     yoga music therapy in sleep quality improvement and glycemic control of type 2 diabetic~     patients with sleep disorders and mild depression.~   "
104544|NCT02198976|"~     The purpose of this study is to collect prospective observational data regarding endoscopic~     management and outcomes of patients with Barrett's oesophagus (BO) with high grade dysplasia~     and/or intramucosal carcinoma. To observe the natural history of patients with low grade~     dysplastic and non dysplastic Barrett's oesophagus~   "
104545|NCT02198963|"~     The purpose of this study is to determine the skin irritation potential of RUT058-60 after~     repetitive patch application to abraded and non-abraded skin of human subjects.~   "
104531|NCT02199145|"~     Membranous Nephropathy (MN) is an auto-immune kidney disease and a common cause of nephrotic~     syndrome. About 30% of MN patients progress to end-stage kidney disease (ESKD) while 30%~     undergo spontaneous remission. The phospholipase A2 receptor (PLA2R1) is the major~     auto-antigen in idiopathic MN. Anti-PLA2R1 autoantibodies are found during the active phase~     of MN. Predictors of disease progression include high titers of anti-PLA2R1 autoantibodies~     and serum creatinine levels at presentation, as well as decline in renal function during the~     first six months of follow-up. Investigators identified new prognostic factors in a cohort of~     41 idiopathic MN patients with nephrotic syndrome and anti-PLA2R1 autoantibodies at the time~     of presentation. During a follow-up of at least 36 months, 21 patients had a persistent~     nephrotic syndrome (group A) and 20 showed partial or total remission (group R). We first~     measured the cross-reactivity of their sera at the time of presentation to human, rabbit and~     mouse recombinant PLA2R1 by western blot. All patients exhibited reactivity against human and~     rabbit PLA2R1, but only some of them did against mouse PLA2R1. These results suggest the~     presence of distinct epitopes that are differentially conserved among PLA2R1~     orthologs.Investigators then set-up three parallel ELISAs using human, rabbit and mouse~     recombinant PLA2R1. All 41 MN patients showed activity in human and rabbit ELISAs at~     presentation but only 32 of them (78%) in mouse ELISA.They finally analyzed the association~     between anti-PLA2R1 titers at presentation in the different ELISAs and the subsequent~     clinical outcome. The mean anti-PLA2R1 activity was significantly different between group A~     and R in mouse ELISA but not in human and rabbit ELISA. Patients with anti-mouse PLA2R1~     activity over 605 RU (relative unit)/ml showed a significantly lower survival without~     doubling of serum creatinine or ESKD , but patients in the highest tertile of anti-PLA2R1~     activity in rabbit and human ELISA did not show a significant increased risk of renal failure~     progression. The results suggest that the specific detection of particular anti-PLA2R1~     autoantibodies using the novel anti-mouse PLA2R1 ELISA can identify MN patients at risk for~     ESKD. The aim is to confirm these result on a prospective cohort.~   "
104532|NCT02199132|"~     Retrospective study of patients diagnosed with a nasopharyngeal carcinoma included in our~     data base care between June 1990 and September 2013.~      Our hypothesis is:~      Our series of patients with a history of nasopharyngeal carcinoma presents epidemiological,~     response rates to the different treatments and survival similar to those described in the~     literature~   "
104533|NCT02199119|"~     The purpose of this study was to describe the effect of 30 min TV viewing with or without~     simultaneous moderate exercise using a treadmill on subsequent subjective appetite,~     satiation, and food intake in normal weight 9 to 14 year old children. It is hypothesized~     that TV viewing during exercise immediately before mealtime affects food intake regulation~     through its effect on the control of appetite and satiation.~   "
104534|NCT02199106|"~     Neuronavigated continuous theta burst stimulation of the left Heschl's gyrus is used to~     modulate auditory cortex activity and plasticity contributing to the perception and distress~     of chronic tinnitus.~   "
104535|NCT02199093|"~     The purpose of this study is to analyze the effects of a mixed intervention of occupational~     therapy (rehabilitative and compensatory approach) at home to upper limb apraxia in mild and~     moderate patients post stroke in comparison to a control group with a traditional health~     educative protocol.~   "
104536|NCT02199080|"~     The purpose of this study is to determine whether D-dimer dosage allow to exclude risk of~     intraatrial thrombus before performing an ablation of atrial fibrillation~   "
104537|NCT02199067|"~     Propofol is a common intravenous anaesthetic drug used for anaesthesia induction and for~     permanent infusion to maintain anaesthesia (total intravenous anaesthesia). Different to the~     volatile anaesthetics (feedback concentrations in exhaled breathing gas) piloting of an total~     intravenous anaesthesia with propofol is done only by experience of the anaesthetist or~     according to pharmacokinetic models. In this study we want to investigate if the exhaled~     fraction of propofol is a potential measurement parameter for piloting anaesthesia. Exhaled~     propofol will be measured with an electrochemical sensor developed by Drägerwerk AG & Co.~     KGaA. Exhaled propofol levels will be compared with the corresponding arterial serum~     concentrations of propofol. Furthermore we investigate the correlation of exhaled propofol~     levels with the Bispectral Index (BIS).~   "
104538|NCT02199054|"~     This research study is being done to help researchers develop new dietary options for~     menopausal women to maintain a healthy weight by developing more nutritious snacks that have~     health benefits. From this study, the researchers hope to gain understanding on how~     menopausal women with metabolic syndrome digest and absorb foods with safflower oil on its~     own and when combined with soy. The research team hypothesize that the two different types of~     pretzels may be processed by your body differently and that components in the pretzel snacks~     may be helpful for preventing diseases like obesity and cancer. Safflower oil and soybeans~     contain many natural chemicals that may benefit human health. However, this relationship is~     not well understood. This study will look at the impact of the pretzel snacks on your blood~     fat and glucose levels as well as a group of chemicals found in soy called isoflavones.~     Isoflavones are natural chemicals found commonly in soybeans or foods made from them.~      Participants will be screened to determine if they qualify in meeting the study requirements.~     Participants cannot have a known allergy to dairy, soy, safflower oil, or wheat protein.~     Also, participants will be asked to stop eating legumes (beans, peas, soy protein, sprouts~     and peanuts) and to document the oils they eat for the entire 14 weeks of this study. The~     study will require five visits to the Ohio State University Clinical Research Center (CRC)~     which part of the Ohio State University's Center for Clinical and Translational Sciences.~     Once the investigators have determined that you qualify for this study and you decide to~     participate, you will be consuming three different pretzels each for one month, starting with~     a control pretzel. After the control pretzel treatment period, you will be randomly assigned~     (like the flip of a coin) to start with one of the two pretzel groups (wheat or soy pretzel~     with safflower oil) for your first treatment period and then switch to the other safflower~     oil pretzel at your second treatment period.~   "
104539|NCT02199041|"~     In this study, participants with high-risk hematologic malignancies undergoing hematopoietic~     cell transplantation (HCT), who do not have a suitable human leukocyte antigen (HLA)-matched~     related/sibling donor (MSD), matched unrelated donor (MURD) or killer-immunoglobulin~     receptors (KIR) ligand mismatched haploidentical donor identified, will receive a combined T~     cell depleted (TCD) haploidentical peripheral blood stem cell (PBSC) and unrelated umbilical~     cord blood transplantation (UCBT) using a total lymphoid irradiation (TLI) based preparative~     regimen.~      Primary objective:~        -  To estimate the incidence of donor derived neutrophil engraftment by day +42~          post-transplant for participants with high-risk hematologic malignancies undergoing a~          total lymphoid irradiation (TLI)-based hematopoietic cell transplantation (HCT) using a~          T cell depleted (TCI) haploidentical donor peripheral blood stem cell (PBSC) donor~          combined with an unrelated umbilical cord blood (UCB) donor.~      Secondary objectives:~        -  Estimate the incidence of malignant relapse, event-free survival (EFS), and overall~          survival (OS) at one-year post-transplantation.~        -  Estimate the incidence and severity of acute and chronic graft versus host disease~          (GVHD) in the first 100 days after transplantation.~        -  Estimate the incidence of secondary graft failure transplant related mortality (TRM) and~          transplant related morbidity in the first 100 days after HCT.~   "
104540|NCT02199028|"~     This research study examines the effect of hyaluronidase on the length of time of insulin~     infusion set wear. The aim of the study is to improve the length of time that an infusion set~     can be worn by infusing hyaluronidase directly into the insulin infusion site. The~     investigators will also assess the accuracy of the Dexcom G4 Platinum (G4P) sensors with~     extended sensor wear beyond the 7 day FDA approved time frame.~   "
104548|NCT02198924|"~     In mainland China, knee Osteoarthritis (OA) is the leading cause of disability in older~     persons. Total knee arthroplasty (TKA) is now generally regarded by orthopaedic surgeons and~     patients as an effective treatment for end-stage knee OA in order to relieve pain, correct~     joint deformity and improve the life quality of patients.However, TKA has been called as one~     of the most painful Orthopedics surgery due to the weight bearing characteristics of knee~     joint and the high demand of functional exercise within the 6-8 weeks post operation. The~     targeted application of selective cyclooxygenase (COX) -2 inhibitor, such as Parecoxib or~     Celecoxib, can significantly reduce the level of inflammatory reaction one and two days~     postoperation . In addition, the perioperative administration of Celecoxib can directly or~     indirectly relieve postoperative pain, improve articular function and eventually augment life~     quality of the patients . Recently, effective treatment of post-operative pain with~     intravenous followed by oral COX-2 specific inhibitor has been demonstrated in many~     post-operative pain models . Significant morphine sparing effect and reduction of opioid~     distressed symptoms were also observed. In China, many surgeons have accept it as a routine~     strategy for controlling pain post TKA to sequentially give parecoxib 40 mg intravenously~     twice daily for the first 3 days post surgery and then Celecoxib 200mg orally twice daily.~     Although satisfactory results of this combination treatment on short-term pain reduction and~     functional improvement has been observed in clinical practice, high quality evidence is still~     lacking to prove its effect on the medium or long-term functionality recovery. This study is~     being conducted to investigate the combination regimen with intravenous parecoxib followed by~     oral celecoxib for post-surgical analgesic treatment in osteoarthritis patients undergoing~     total knee arthroplastic (TKA) surgery. Subjects will receive double-blinded study medication~     consisting of parecoxib injection in analgesic doses or matching placebo followed by oral~     celecoxib in acute pain doses or matching placebo in a double-blinded fashion. The hypothesis~     is subjects treated with parecoxib/celecoxib will consume less morphine over the first 24~     hours of postoperation period, achieve improved pain control over study period, a quicker~     return to functionality, and has less opioid adverse events than those treated with opioids~     alone over 6-week recovery phase.~   "
104549|NCT02198911|"~     The purpose of this study is to examine if chewing gum before an eating bout will increase~     the rate of habituation and subsequently reduce energy intake within the eating bout.~   "
104550|NCT02198898|"~     This study is to evaluate the efficacy of GUARDIX-SGⓇ for patients with gastrectomy in Korea~     and the investigators hypothesized applying of adhesive preventing agent would reduce~     incidence of adhesive obstruction after gastrectomy.~   "
104551|NCT02198885|"~     The NanoMaxx Ultrasound System (SonoSite) in connection with the RP-Xpress (InTouch~     Technologies) provides a means of transmitting ultrasound images, video, and audio to a~     remote location in real-time. It has been envisioned that this system be used to diagnose~     trauma patients with suspected pleural effusion, hemothorax, pneumothorax, or abdominal~     blockage during prehospital care; under the guidance of in-hospital physicians, paramedics~     would perform an Focused Assessment with Sonography for Trauma (FAST) examination while~     trauma patients are transported to hospital via ambulance. The investigators hypothesize that~     in-hospital physicians interpreting ultrasound images obtained by paramedics during trauma~     patients' transportation to hospital will reduce time to diagnosis; thus, preparations by~     emergency physicians, surgeons, and operating room teams to receive critically injured~     patients may begin earlier, reducing time to intervention during a critical period in patient~     care. Data will also be collected regarding quality of images obtained in-ambulance and the~     interaction between paramedics and physicians using the remote-presence system.~   "
104552|NCT02198872|"~     In the pathophysiological process of coronary artery disease (CAD), are present, autonomic~     dysfunction and reduced functional capacity. Studies showed that physical training (PT) is~     critical in the treatment of CAD by promoting beneficial effects. Although water based~     exercises program have been documented in patients with various cardiovascular diseases, the~     most of studies among patients with CAD used land based exercises programs. OBJECTIVE: To~     evaluate and compare the effects of aerobic water (WPT) and land (LPT) based PT on autonomic~     modulation of heart rate (HR), body composition and cardiorespiratory and metabolic variables~     in patients with CAD. METHODS : 40 men between 50 and 70 years old with CAD diagnosed by~     coronary angiography showing obstruction greater than 50% and underwent angioplasty will be~     evaluated in 4 stages; 1) immediately after angioplasty, clinical assessment, body~     composition analysis and recording of HR and NN intervals during rest. 2) The components of~     step 1) will be repeated after three month, adding the record of HR and NN before, during and~     after the Valsalva maneuver, spirometry and cardiopulmonary exercise testing. 3) Volunteers~     will be randomly divided into two groups, WPT and LPT for 48 sessions. 4) The components of~     step 2) are repeated after each period of 12 sessions. Thus, it is expected that WPT promote~     beneficial physiological adaptations in CAD patients with obstruction greater than 50%.~   "
104553|NCT02198859|"~     Laboratory testing has suggested that lithium may decrease the incidence of certain types of~     cancer, including prostate cancer. Additional research has suggested that lithium decreases~     prostate cancer tumor size over time. This study will investigate the effect of lithium on~     men with prostate cancer.~   "
104554|NCT02198846|"~     Insulin deficiency resulted from progressive beta cell failure and insulin resistance in type~     2 diabetes requires exogenous insulin therapy, escaping from oral antihyperglycemic agents.~     Previous data have been suggested that continuous subcutaneous insulin infusion (CSII) does~     not only have efficacy in glucose control but also restore beta cell failure.~      The investigators plan to compare the efficacy/safety and beta cell function between insulin~     pump treatment and the intensification of conventional treatment in patients with~     uncontrolled type 2 diabetes.~   "
104555|NCT02198833|"~     The purpose of this study is to determine if the study Foley catheter with its patterned~     external surface can delay the time to the onset of urinary tract infection in spinal cord~     injury patients who are dependent on a Foley catheter for drainage of their urinary bladder.~   "
104556|NCT02198820|"~     Inclusion of all patients with femoral neck fracture presenting in Saint-Luc Bouge Hospital~     between October 1th 2014 and September 30th 2015.~      Comparison of severity scores of these patients and the scale of Nottingham on immediate (day~     1 and day 2) and late (1 month) outcome.~   "
104557|NCT02198807|"~     The objective of this study is to explore the role of fosmidomycin and piperaquine as~     non-artemisinin-based combination therapy for acute uncomplicated Plasmodium falciparum when~     administered over three days.~      Together, fosmidomycin and piperaquine fulfil the WHO criteria for combination therapy by~     meeting the three key parameters of having different modes of action and different~     biochemical targets while exhibiting independent blood schizonticidal activity. Like the~     artemisinins, fosmidomycin is fast-acting, has an excellent safety record and is active~     against existing drug-resistant parasites. Piperaquine has a long half life protecting~     fosmidomycin as a much shorter lived molecule against selection of resistant parasites and~     will provide post-treatment prophylaxis.~   "
104663|NCT02197416|"~     This open-label, single arm prospective cohort study will assess the safety of dabigatran~     etexilate in secondary prevention of venous thromboembolism in paediatric patients. Children~     from 0 to less than 18 years of age will be eligible to participate.~   "
104559|NCT02198781|"~     This is a pilot study into the effects on heart function when pacing the right ventricle~     (RV). This study aims to enrol a population who are clinically indicated to receive a~     pacemaker.~      When normal conduction within the heart fails, the treatment may be to implant a permanent~     pacemaker. Pacing involves passing a lead via a vein to the heart and using an electrical~     impulse to stimulate a beat.~      Increasingly the available evidence suggests that long term RV pacing is associated with~     complications - left ventricule (LV) dysfunction, heart failure, atrial fibrillation (AF) and~     death in some patients. What we do not see are a large proportion of all patients who receive~     pacemakers suffering pacing related adverse effects.~      If there could be a way of identifying those patients in the group who go on to develop~     pacing induced cardiomyopathy at the time of initial pacing implant, this would be a very~     valuable clinical measure. These patients could be identified from the outset and paced with~     a biventricular device to avoid the pacing induced cardiomyopathy. Whilst much energy has~     been directed towards the LV as a focus of the clinical markers of disease, little has been~     published looking at RV haemodynamics.~      We plan to study a cohort of patients who are clinically indicated to receive a pacemaker and~     study their RV in detail at the time of implantation. We will use conductance catheters and~     echocardiography to determine measures of pumping function. We will then follow them up for a~     period of six month using echocardiography and blood markers of heart dysfunction. In those~     patients who have a reduction in heart function we will then look for common patterns within~     their initial measurements.~   "
104560|NCT02198768|"~     The purpose of this study is to compare outcomes of patients with an ankle fracture to those~     with ankle fracture-dislocations. We hypothesize that long-term clinical outcomes for~     patients sustaining ankle fracture dislocations are poorer than those without dislocation.~   "
104561|NCT02198755|"~     The purpose of this study is to establish the sensitivity of HRUS as compared to MRI for the~     diagnosis of osteomyelitis in chronic wound patients; and to determine the specificity of~     HRUS as compared to pathologic and microbiologic studies of bone biopsy tissues.~   "
104562|NCT02198742|"~     The study is a randomized crossover study where anesthesia practitioners will intubate three~     different pediatric infant mannequins (normal airway, anterior larynx, Pierre Robin syndrome~     anatomy) using three different intubation devices (the Miller blade, the Truview VL, the~     Glidescope Cobalt video-laryngoscope) in two different scenarios (normal neck and with an~     immobile neck). The order of presentation will be randomized. As this is a cross over study,~     all subjects will complete all scenarios. There is no placebo group, and each subject wil be~     his or her own control.~   "
104563|NCT02198729|"~     The investigators have recently become proficient in a new, and we believe more effective~     technique for polyp removal. Known as Endoscopic Submucosal Dissection (ESD). ESD involves~     removing the polyp in one piece. It is preferable to remove the polyp in one piece as it~     minimises the chance of leaving residual polyp tissue behind. There have also been recent~     studies overseas that have shown this new technique to be quite effective. In this study,~     half of the patients will receive the newly developed technique of polyp removal (ESD), while~     the other half will receive conventional Endoscopic Mucosal Resection (EMR) treatment. This~     study will allow us to show which technique results in lower recurrence rates and is more~     effective.~   "
104564|NCT02198716|"~     The treatment of complex coronary disease causing limiting symptoms of angina with~     drug-eluting stent technology will prove superior to bare metal stent technology, with~     respect to a combined endpoint of mortality, MI, requirement for target vessel~     revascularisation and severe haemorrhage, in patients aged 80 or above.~   "
104565|NCT02198703|"~     This study aims to demonstrate the effect of the chronic consumption of AB-Life probiotic~     blend on blood LDL cholesterol level in volunteers with moderate hypercholesterolemia.~   "
104566|NCT02198690|"~     The aim of this study is to test whether an educational pamphlet on mammography designed for~     women aged 75 and older improves older women's decision-making around mammography screening.~     The investigators aim to show that the educational pamphlet improves older women's knowledge~     of the pros and cons or screening and leads to fewer women in poor health with short life~     expectancy being screened.~   "
104567|NCT02198677|"~     The aim of the investigators study is to investigate whether posteriorly directed (AP)~     pressures and laterally directed (LAT) glides, cause blood pressure and heart rate elevation~     or lowering in patients with neck pain. The answer will advance the investigators~     understanding of why manual therapy works.~   "
104568|NCT02198664|"~     This is a multi-center, open-label, follow-on study to gather additional information on the~     safety and tolerability of oral desensitization with CPNA in the subjects who participated in~     ARC001.~   "
104569|NCT02198651|"~     A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging~     TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of~     Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) Subjects (PREDICTRA).~   "
104570|NCT02198638|"~     Hospital acquired influenza is associated with significant morbidity and mortality in~     hospitalized patients notably elderly patients. Vaccination of HCW is recommended to prevent~     influenza transmission in healthcare setting.~      Outbreaks of hospital acquired influenza were reported in stays with high vaccine coverage in~     patients (higher than 85%). It is necessary to underline that an adequate vaccine cover in~     the elderly population will not necessarily result in a total control of the incidence.~     Consequently, the prevention of influenza outbreaks in this vulnerable population must also~     include the reduction of the exposure to the influenza viruses, in particular thanks to the~     vaccination of HCW.~      A pilote case-control study, implemented in Edouard Herriot hospital (at Lyon University~     hospitals), indicates that a shielding effect of more than 35% of vaccinated HCW on hospital~     acquired influenza among patients (Bénet et al.; BMC Infectious Diseases 2012). The results~     suggest a protective effect but investigations, carried out on a more important sample are~     needed to validate the benefit of HCW vaccination.~      The aim of this prospective multicentric cohort study is to estimate incidence of influenza~     among hospitalized patients according to % of influenza vaccination of HCW in short stay~     units.~   "
104571|NCT02198625|"~     The purpose of this study is to determine the influence of moderate FiO2 and the lung~     protective ventilation on postoperative pulmonary complications following hepatic resection~     surgery.~   "
104572|NCT02198612|"~     Over the past years, arterial closure systems have tended to replace manual compression to~     ensure hemostasis at femoral artery puncture points. Arterial closure systems reduce~     hemostasis and patient immobilization times, thus enabling early resumption of walking. These~     devices have contributed extensively to the development of outpatient stays for cardiology,~     vascular and neuro-radiology procedures.~      According to certain studies however, it would appear that arterial closure devices do not~     present any greater benefits than manual compression in terms of hemostasis and~     complications. Moreover, the use of increasingly small diameter instruments would tend to~     render manual compression sufficient. Finally, the use of these devices generates additional~     costs.~      The purpose of our study is to evaluate the feasibility and safety of manual compression~     before early resumption of walking in patients managed by conventional hospitalization for a~     diagnostic or therapeutic endovascular procedures by retrograde femoral puncture with 5F~     guide catheter.~   "
104573|NCT02198599|"~     Objectives: This parallel RCT investigated the effect of a new nursing intervention (Mobility~     Enhancing Nursing Intervention - MFP) designed to improve the rehabilitation programs'~     outcomes and patients' quality of life.~      Intervention: The IG combined standard care with the 30-day mobility-enhancing-nursing~     intervention (MFP). MFP placed patients on a mattress on the floor and used constant~     tactile-kinaesthetic stimulation in everyday tasks to increase spatial orientation, to teach~     patients to get up safely and to move independently.~      Primary and secondary outcome measures: Outcomes were defined as functionality (Extended~     Barthel Index, EBI), quality of life (WHOQoL), and fall-related self-efficacy (FES-I).~   "
104574|NCT02198586|"~     The purpose of this study is to investigate the influence of the APOE genotype on brain~     morphology, function and metabolism, related to other factors such as cognitive reserve,~     cognition and episodic memory, in subjects at greater risk of developing AD.~   "
104575|NCT02198573|"~     -  Artemisinin resistance have been documented in Myanmar and Myanmar artemisinin~          resistance containment measures have been launched since 2009-2010.~        -  It is important to monitor the spread and magnitude of artemisinin resistant malaria in~          Myanmar.~        -  So, day-3 surveillance study have been conducted.~        -  Recently artemisinin resistant molecular marker, K13 have been identified and it was~          used as a tool in this study.~   "
104576|NCT02198560|"~     The primary objectives of the study are to assess the agreement between the two different~     scan mode of the RS-3000 Lite.~   "
104577|NCT02198547|"~     The aim of the study is to evaluate if Magnesium added to ropivacaine can reduce onset time~     and can enhance offset time.~   "
104578|NCT02198534|"~     A) For the investigation of Visual acuity, inter-test agreement and the test-retest~     reliability were used three different visual acuity tests: ETDRS charts, Landoltring chart~     and Freiburg Visual Acuity Test (FrACt). The examinees passed each visual acuity test twice~     but the sequence of the visual acuity tests were randomize and so different for each~     examinee. The examinees were 24 adult Aalen university students (except students of~     ophthalmic optics in terms 2 - 7) with a minimal distant visual acuity without or with~     correction of 0.2. Another inclusion criteria was a maximum myopia of sph -2,00 dpt, a~     maximum hyperopia of sph +5,50 dpt and a maximum astigmatism of cyl 2,50 dpt. The Landolt C~     was projected in eight-orientations. For the FrACT Test we used two different devices for~     response input: a modified keypad with Landoltring symbols (FrACTk) and a haptic Landolt~     device with an adjustable Landoltring (FrACTh). The primary objective was the comparison~     between FrACTk and FrACTh. The secondary Objective contains the comparison between all visual~     acuity tests.~      B) Background: Landolt Cs and letters are commonly used optotypes. In the explorative study~     we compare four different ways of applying them: The Freiburg visual acuity test (FrACT)~     using a keypad and a haptic Landolt device, a Landolt C chart in accordance to ISO 8596 and~     DIN 58220 with eight-orientated Landolt C and ETDRS charts. The aims of the survey were to~     determine examinee´s/examiner´s subjective ratings using Visual analogue scales (VAS), the~     inter-test agreement between the tests and test-retest reliability of the tests, concerning~     the test duration.~      Subjects and Methods: Twenty-four adult examinees with a visual acuity of ≥ 0,2 were included~     in the explorative study. The visual acuity of one eye was measured monocularly, randomized~     with regard to the leading/non-leading eye. The subjects passed every visual acuity test~     twice in a randomized sequence of the visual acuity tests, which is maintained by a~     pre-specified randomization list, making use of forced choice.~   "
104579|NCT02198521|"~     Title Staged Bilateral Carpal Tunnel Release: Which Side Hurts More? Primary null hypothesis~     Patients undergoing staged bilateral open Carpal Tunnel Release (CTR) have no difference in~     overall pain intensity of pain between sides.~      Secondary null hypotheses~        -  There is no correlation in overall pain intensity after open CTR surgery and distal~          sensory latency, distal motor latency, electromyography (EMG), demographics, occupation,~          avocation, relevant comorbidities, dominance, left vs. right, Pain Self-Efficacy,~          Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity or~          PROMIS depression when both surgeries are performed within 6 months.~        -  There is no difference in satisfaction with treatment at the time of suture removal~          after the first and second open CTR surgery when both are performed within 6 months..~      IRB: 2009-p-001-019 ClinicalTrials.gov: Not mandatory, (b/o observational) Authors:~     Drijkoningen, Braun, Ring Journal: To be discussed Design: Prospective cohort study~     Background Many hand surgeons note that patients undergoing staged bilateral open carpal~     tunnel release often experience more pain with the second side. The investigator felt this~     was an easily testable hypothesis worthy of study.~      Subjects~      Eligibility:~      Inclusion:~        -  Age 18 or older~        -  Idiopathic carpal tunnel syndrome~        -  No prior surgery for carpal tunnel syndrome~      Exclude:~        -  Pregnant women~        -  Not fluent in English~      Response Variables:~        -  11-point ordinal measure of overall pain intensity during and after surgery measured at~          the time of suture removal.~        -  11-point ordinal measure of satisfaction with treatment~        -  PROMIS upper extremity~      Explanatory Variables:~        -  Distal Sensory Latency (DSL)~        -  Distal Motor Latency (DML)~        -  EMG changes~        -  Demographics: age, sex, race, occupation, avocation~        -  Time limit between two surgeries < 6 months~        -  Relevant comorbidities: Trapeziometacarpal (TMC) arthrosis, ulnar neuropathy, trigger~          finger~        -  Involved hand (Dominance, Side)~        -  First side vs. second side surgery~        -  PROMIS Pain Interference Computer Adaptive Testing (CAT)~        -  Pain Self Efficacy Questionnaire (PSEQ-2)~        -  PROMIS Depression~      Methods The investigator and study staff will invite all adult patients (age 18 and older)~     presenting to the Orthopaedic Hand and Upper Extremity Service Department at Massachusetts~     General Hospital (MGH) with bilateral carpal tunnel syndrome planning staged bilateral carpal~     tunnel release.~      Analysis Power analysis An a priori power analysis for matched pairs was performed. To detect~     the difference between two dependent means an effect size of 0.5 at alpha of 0.05 and 80%~     power, a total sample size of 34 patients is needed.As the investigator expects to have~     patients who will be lost to follow-up the investigators will count 10% extra, a total of 38~     patients will be needed.~      Univariate analysis: Variables will be presented with frequencies and percentages for~     categorical variables and as mean with standard deviation or median with interquartile range~     for respectively normal or non-normal distributed continuous variables. Normality of~     continuous distributed variables will be tested a paired T-Test.~      Bivariate and multivariable analysis will be performed and subsequently all variables with a~     probability < 0.10 in bivariate analysis will be inserted in a backward, stepwise,~     multivariable linear regression analysis to assess their ability to explain variation in~     outcome. The 11 point Likert Pain scale score is considered significant when there is a~     difference of more than 1.4 points (2.8 SD*0.5 effect size)on a scale from 1-10.[9]~   "
104580|NCT02198508|"~     Background: Three iron chelators now available on the market differ in toxicity and organ~     specificity; evidence on standardized chelation protocol remains inconclusive, but patients~     with transfusion-dependent beta-thalassemia treated with DFO infusion show significant~     differences in the limitations of daily activities, physical activity, and quality of life~     when treated with oral chelator. With licensing of DFP in America, it is reasonable to~     combine DFP with DFX. Patients find two oral chelators more acceptable than one oral and one~     injectable. This pilot study rates use of DFP for improving iron excretion profile of~     deferasirox.~      Methods: The investigators enrolled 13 beta-thalassemia patients in China Medical University~     Children's Hospital in May 2009-October 2011. Five refused to take part in pharmacokinetics;~     they only participated in iron excretion study. Seven with irregular bowel function were~     unable to collect feces in the screening period as baseline data. Subjects were randomly~     assigned and rotated to undergo all treatments (with informed consent): (A) single oral dose~     of DFX 30 mg/kg once daily, (B) single oral dose of DFP 40 mg/kg twice a day, (C) oral doses~     of DFX and DFP administered sequentially (DFX 30 mg/kg/d, deferiprone 40 mg/kg/d and~     deferiprone 40 mg/kg/d at 7-hour intervals). Three-day drug dosage was followed by four-day~     washout. Collections of urine and stool proceeded 24 hours per day, each analyzed separately.~     Through a venous catheter, serial blood samples (1 mL/each sampling) were collected in glass~     tubes containing heparin as anticoagulant at Time 0 (pre-dosing) and at 0.5, 1, 1.5, 2, 2.5,~     3, 3.5, 4, 4.5, 6, 7, 8, 10, 12 and 24 hours after dose; plasma concentrations of DFP and DFX~     were measured.~   "
104581|NCT02198495|"~     Patients with end-stage kidney disease on maintenance hemodialysis frequently require iron~     supplementation to compensate for ongoing iron losses, and to maintain hemoglobin levels with~     or without additional use of erythropoiesis-stimulating agents (ESA).~      The investigators aim to compare two different intravenous iron preparations, ferric~     carboxymaltose and iron sucrose in 140 hemodialysis patients. The investigators primary~     objective is to assess whether both agents are equally effective to maintain a target~     haemoglobin within 10-12 mg/dl. The investigators will also measure ferritin, transferrin,~     transferrin saturation, and how much ESA therapy is administered.~      Patients will be randomly assigned to either treatment group and followed in parallel over an~     active study period of 40 weeks.~   "
104582|NCT02198482|"~     Randomized Phase II Trial of Intensive Chemotherapy With or Without Volasertib (BI 6727) in~     Patients With Newly Diagnosed High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid~     Leukemia (AML)~   "
110512|NCT02120924|"~     The purpose of the study is to compare the safety and efficacy profiles of a generic Azelaic~     Acid Gel, 15% to the reference listed Finacea® (azelaic acid) Gel, 15% in the treatment of~     moderate facial rosacea.~   "
104584|NCT02198456|"~     The aim of the study is to intensify the follow up of patients with pulmonary arterial~     hypertension via modern imaging guided methods in due consideration of the possibilities of~     three-dimensional echocardiography in order to optimize their specific therapy.~      The hypothesis is that the increased use of modern imaging guided tools is essential for the~     follow up.~   "
104585|NCT02198443|"~     The main objective of this study is to compare the tolerability and adherence to a new drug~     regimen of post-exposure prophylaxis (PEP) for HIV,~   "
104586|NCT02198430|"~     Multidisciplinary assessment of the physical, functional and psychosocial alterations in~     patients with hemophilia around the country. The aims of this study are:~        -  Descriptive study of joint involvement in hemophilia patients with and without a history~          of hemarthrosis.~        -  Descriptive study of the alterations of periarticular muscle strength as a result of~          acute processes or the development of chronic articular sequelae.~        -  Descriptive study of biomechanical changes in lower limb joints and their impact on gait~          in patients with hemophilia.~        -  Descriptive study of the joint space, regarding hemarthrosis and synovitis,~          intraarticular by ultrasonography.~        -  Descriptive study of the relationship between skeletal muscle pathology in patients with~          hemophilia and their perceptions of it and their quality of life.~   "
104587|NCT02198417|"~     PCOS occurs when a woman does not release an egg regularly each month, causing her periods to~     be irregular. Women with PCOS can also have increased hair growth on the face and body, acne,~     head balding, infertility, pre-diabetes, and diabetes. PCOS is commonly treated with oral~     contraceptive pills (also known as the birth control pills). Sometimes, a medication called~     metformin is also used to treat PCOS, especially if a woman has evidence of insulin~     resistance or if fertility is desired. Unfortunately, metformin works in only some women with~     PCOS. The mechanism through which metformin works in PCOS is not clear and it difficult to~     predict who will benefit from metformin treatment and who will not.~      The investigators are doing this research study to look at how the medication metformin~     affects the cells in the body of patients with PCOS. Specifically, the investigators will~     look at how metformin affects the mitochondria. Mitochondria are the part of cells that~     produce fuel (energy) for other cells and play a role in metabolism. The investigators would~     like to see whether there is a relationship between mitochondrial activity and symptoms of~     polycystic ovary syndrome (PCOS) before and after treatment with metformin. They would also~     like to study whether genes affect the response to metformin in women with PCOS.~   "
104588|NCT02198404|"~     In the palliative care unit, certain patients suffer from pain associated with medical~     procedures/care which is poorly controlled by antalgics. These situations may necessitate~     temporary sedation to improve comfort and facilitate treatment. No proven consensus exists,~     either in the literature or in clinical studies conducted, on the choice of sedative agent~     however Midazolam is the general recommendation.~      The investigators believe that Propofol could be used in this instance~   "
104589|NCT02198391|"~     This study aims to investigate safety and efficacy of Echinaforce Junior tablets in two~     dosages of 3 x 1 and 5 x 1 tablets per day in children 4 - 12 years old with acute colds.~   "
104590|NCT02198378|"~     In the management of acute coronary syndromes with ST-segment elevation (STEMI), early~     analgesia reduces the effects of hyperadrenalism which increases the size of myocardial~     infarction. In order to reduce pain intensity, the recommendations advocate emergency use of~     morphine. In STEMI patients, other analgesic treatments could provide analgesia that is at~     least as effective as morphine. The equimolar oxygen/nitrous oxide mixture (MEOPA) is widely~     used in emergency medicine and has minor secondary effects that are very rapidly reversible~     when inhalation is discontinued. Used in association with paracetamol, it could be an at~     least equally effective alternative to the use of morphine.~   "
104591|NCT02198365|"~     The investigators hypothesis is HPV integration could result in expression of oncogene~     transcripts, and not only constitutive expression but also the level of expression will be~     decisive for transformation and the maintenance of the malignant phenotype. Moreover, the~     expression and level of HPV viral transcripts not HPV DNA viral loads is correlated to the~     severity in cervical intraepithelial neoplasia (CIN) and cervical carcinomas (CxCa).~   "
104592|NCT02198352|"~     The objective of the present study is to obtain information about the safety, tolerability~     and pharmacokinetics of BIBN 4096 BS after single intravenous administration of increasing~     doses in healthy male and female volunteers~   "
104593|NCT02198339|"~     Efficacy, Safety, Tolerability and Pharmacokinetics of BIBN 4096 BS in patients with a single~     acute migraine attack with or without aura~   "
104594|NCT02198326|"~     The objective of the present study is to obtain information about the safety, tolerability~     and pharmacokinetics of BIBN 4096 BS after single intranasal administration of increasing~     doses in healthy male and female volunteers~   "
104595|NCT02198313|"~     The objective of the present study is to obtain information about the safety and tolerability~     of multiple increasing doses of BIIX 1 XX and to obtain preliminary pharmacokinetic data~   "
104596|NCT02198300|"~     Coronary bifurcation lesions pose therapeutic problems during percutaneous coronary~     interventions (PCI) and are associated with higher rates of periprocedural complications as~     well as higher rates of in-stent restenosis and stent thrombosis. Provisional T-stenting~     (PTS) is the best treatment strategy at the moment. However, the optimal approach to coronary~     bifurcations treatment is still a subject of debate, especially when the side branch is~     large, not easily accessible and narrowed by a long lesion. One of the proposed alternatives~     are dedicated bifurcation stents (DBS). However, there is large scarcity of randomized trials~     with DBS. POLBOS II study is continuation of POLBOS I (POLish Bifurcation Optimal Stenting)~     study, in which paclitaxel-eluting stent BiOSS Expert® (Balton, Poland) was assessed. Now~     performance of sirolimus-eluting stent BiOSS LIM® (Balton, Poland) is verified.~   "
104597|NCT02198287|"~     Safety, tolerability and pharmacokinetic study of BIIX 1 XX in healthy male volunteers.~   "
104598|NCT02198274|"~     Study to evaluate the anti-tumour activity, safety and pharmacokinetics of unlabelled~     sibrotuzumab administered weekly (seven days +/- one day) at a dose of 100 mg (a total of 12~     administrations) in patients with metastatic colorectal cancer.~   "
104664|NCT02197403|"~     1. Adequate sedation with classical sedative agents, propofol~        2. Sedation with propofol may induce paradoxical excitement response in heavy alcohol~          drinkers~        3. Dexmedetomidine, α2 receptor agonist, may provide adequate sedation in heavy alcohol~          drinkers~   "
104599|NCT02198261|"~     Topical minoxidil is the most common drug used for the treatment of AGA in men. While topical~     minoxidil exhibits a good safety profile, the efficacy in the overall population remains~     relatively low i.e., 30-40% re-grow hair. To observe significant improvement in hair growth,~     minoxidil is typically used twice daily for a period of at least 16 weeks. Due to the~     significant time commitment and low response rate, a diagnostic test to identify~     non-responders prior to initiating therapy would be advantageous.~      Minoxidil is converted in the scalp to its active form, minoxidil sulfate, by the~     sulfotransferase enzyme SULT1A1. The enzyme expression is variable among individuals. We have~     demonstrated in two prior feasibility studies that the SULT1A1 enzyme activity in plucked~     hair follicles correlates with minoxidil response in the treatment of AGA and thus can server~     as a predictive biomarker.~      Consequently, we developed a minoxidil response in-vitro diagnostic kit intended to identify~     non-responders prior to initiating therapy with 5% topical minoxidil foam.~      The primary purpose of this study is to evaluate the clinical validity of the minoxidil~     response in-vitro diagnostic kit.~   "
104600|NCT02198248|"~     Previous reports suggested conventional immunosuppressants such as cyclophosphamide could not~     reduce glucocorticoid dose in remission induction in ANCA-associated vasculitis because of~     lower remission rate and higher relapse rate. However those reports didn't include rituximab.~      B cell depletion therapy by rituximab is a new strategy for remission induction in~     ANCA-associated vasculitis. The RAVE and RITUXVAS trial (NEJM 2010, both) showed high-dose~     glucocorticoid plus rituximab had roughly the same efficacy and safety as high-dose~     glucocorticoid plus IV-cyclophosphamide. In addition, recent retrospective observational~     studies reported low-dose glucocorticoid plus rituximab led to re-induction in severe~     relapsing ANCA-associated vasculitis.~      Thus, the investigators aim to investigate whether rituximab can reduce glucocorticoid dose~     in induction remission in ANCA-associated vasculitis (to show non-inferiority for efficacy~     between low-dose and high-dose glucocorticoid plus rituximab). Participants will be~     randomised to the low-dose glucocorticoid plus rituximab or the high-dose glucocorticoid~     plus rituximab groups. Primary endpoint is proportion of remission at 6 months, then data~     regarding relapse and long-term safety will be collected until 24 months.~      The study has been designed by the principal and coordinating investigators. It will include~     140 participants from 18 hospitals in Japan. It is funded by Chiba University Hospital and~     Chiba East Hospital.~   "
104601|NCT02198235|"~     This study looks at addition of medications to the local anesthetic for the nerve blockade.~   "
104602|NCT02198209|"~     Type 2 diabetes is a chronic disease that has reached epidemic proportions. In order to~     improve our strategies for preventing and treating type 2 diabetes the investigators need to~     better understand the mechanism of this disease, and the way in which current therapies, such~     as the drug liraglutide, work to control blood sugar. It is known that liraglutide acts via~     increasing the secretion of the hormone insulin from the pancreas, hormone that in turn~     controls blood sugar. However, it is not known whether liraglutide also has actions on the~     liver. Animal studies have suggested that liraglutide might act by controlling the liver~     enzyme glucokinase (GCK), an enzyme that increases blood sugar uptake by the liver. This~     could be a crucial mechanism in which liraglutide controls blood sugar independently of~     insulin, thus making it beneficial not only in type 2 but also in type 1 diabetes. The effect~     of liraglutide on GCK activity has not been yet measured in humans. The investigators propose~     to investigate the acute and chronic effect of liraglutide on GCK by using a simple, widely~     used procedure (an IntraVenous Glucose Tolerance Test-IVGTT) and a novel approach~     (mathematical modeling of data obtained from this procedure), to assess GCK activity in~     people with type 2 diabetes. The investigators will first compare data obtained form 2 IVGTTs~     (with and without liraglutide) performed 1 week apart (acute effect). The investigators will~     then give liraglutide to patients for 6 weeks and do another IVGTT to measure GCK activity~     (chronic effects). Data obtained from this study will be used to further understand the~     mechanism of liraglutide action and how to better employ our current therapeutic options and~     develop new strategies for preventing and treating diabetes.~   "
104603|NCT02198196|"~     The purpose of this study is to explore the efficacy of a phone-based weight loss program~     that has stress management techniques integrated throughout (Weight Talk-Mindfulness). The~     program is targeted at employees of certain companies who meet a cut-off score on a measure~     of stress-related eating. The control group will receive a standard phone-based program with~     no additional stress management information (Weight Talk-Standard).~        -  Hypothesis 1: Participants in Weight Talk-Mindfulness (WT-M; n=50) will experience~          decreases in their stress-related & emotion-related eating compared to the Weight~          Talk-Standard (WT-S; n=25) group.~        -  Hypothesis 2: The WT-M group will lose more weight compared to the WT-S control group.~        -  Hypothesis 3: Participants in WT-M will experience decreased perceived stress, increased~          eating self-efficacy, increased acceptance of weight-related thoughts & feelings and~          increased mindfulness compared to those in the WT-S control arm.~        -  Hypothesis 4: Participants in WT-M will be equally as satisfied with their weight loss~          program as those in WT-S.~   "
104604|NCT02198183|"~     The purpose of this study is to measure cerebral oxygenation and cardiac output of total~     shoulder replacement patients undergoing general anesthesia (GA) and positive-pressure~     ventilation (PPV).~      We hypothesize that cerebral desaturation occurs frequently during GA with PPV, but is rare~     during GA and spontaneous ventilation. We also hypothesize that cardiac output usually is~     well maintained under GA in the sitting position when epinephrine is used, but that decreased~     cardiac output increases the risk of cerebral desaturation.~   "
104605|NCT02198170|"~     The purpose of this study is to assess the influence of simultaneous CYP3A4 and~     p-glycoprotein inhibition on lenvatinib pharmacokinetics following a single oral dose of 5 mg~     lenvatinib.~   "
104616|NCT02198027|"~     Patients may feel significant pain at the surgery site after they wake up from the surgery.~     Usually pain is managed in the ward by giving strong pain medication that may slow down your~     mobilization and recovery process. Some recent work in other countries has shown that if~     investigator give patients an injection at the end of the operation, patients have less need~     for pain medication when they wake up. If investigator find that is also true in our~     population, then we can use this method as routine step after this operation to improve pain~     management and early mobilization of our patients~   "
126763|NCT01908231|"~     To prospectively investigate the association between plasma lactate concentration and~     short-term adverse outcomes in patients with acute PE.~   "
104606|NCT02198157|"~     -  Labor is divided into three stages: the first stage is from labor onset until full~          dilation, second stage is from full dilation until delivery of the baby, and the third~          stage from the delivery of the baby until the delivery of the placenta~        -  The mean duration of second stage in nulliparas as defined by the American college of~          obstetricians and gynecologists (ACOG) is 54 minutes~        -  Epidural anesthesia is a known cause for prolongation of the second stage of labor.~          Prolonged second stage in nullipara women with epidural is defined as more than 3 hours,~          and more than 2 hours in those without epidural.~        -  Although perinatal outcome is not compromised with a prolonged second stage , there is~          evidence that maternal morbidities such as perineal trauma, chorioamnionitis~          ,instrumental delivery and postpartum hemorrhage increase with prolonged second stage~        -  Another effect of epidural anesthesia during labor is urinary retention and a need for~          catheterization.~        -  Full bladder may behave as a tumor previa and interfere to fetal head descent in the~          birth canal, increasing by that the duration of the second stage.~        -  This study aims to investigate the effect of intermittent versus continuous~          catheterization on the duration of the second stage of labor~   "
104607|NCT02198144|"~     African American men have the highest risk of any group for early death & disability from~     high blood pressure (BP). Clinical investigations in Dallas, TX demonstrated that African~     American men with high BP are able to improve their BPs when participants agree to have their~     BP measured at their barbershop by their barber & also take BP reducing medication as~     instructed by a healthcare team that includes their doctor. The goal of this study is to~     bring a barbershop-based model of BP measurement, treatment & follow-up from Dallas, TX to~     the Southern California area. This study is the 2nd of two Barbershop studies at~     Cedars-Sinai Medical Center. The 1st study was called the Barber-Based Intervention for~     Hypertension in Black Men: Baseline Data Collection. In this 2nd study at Wally's~     barbershop, the Investigators will enlist pharmacists to integrate the community health~     promotion program in barbershops into the healthcare system. Barbers are uniquely positioned~     to facilitate hypertension case detection & referral, pharmacists are uniquely positioned to~     facilitate case management. Pharmacists have extensive knowledge of BP medication & they have~     earned the respect of patients and physicians alike. In this intervention study, barbers will~     be trained to measure the BP & refer those who have already been identified as having high BP~     to a community pharmacist for confirmation of uncontrolled high BP & development of a BP~     management plan. The pharmacist will work with the customers' physicians to optimize the BP~     medication prescribed & with individual customers to provide a user-friendly medical home.~     Pharmacists will improve the customer's access to state-of-the-art medical care, The data~     from this study will be used to apply for a new NIH Grant. In addition, the summarized data~     will be shared with key stakeholders in the local community (including barbers, patrons,~     local healthcare providers, local pharmacists & other community leaders) to design a larger~     community-partnered intervention.~      Specific Aims:~      Aim 1. To evaluate the impact of the new intervention model on HTN control in African~     American males.~      Aim 2. To evaluate the cost-effectiveness of the new intervention. The investigators~     hypothesize that the projected cost-savings to the healthcare system in reduced heart attack~     & stroke care will outweigh intervention & medication costs.~   "
104608|NCT02198131|"~     This pilot trial studies pulsed dye laser in treating patients with post radiation dysphonia.~     Dysphonia, or vocal cord scarring, can include trouble with the voice when trying to talk,~     such as hoarseness, change in voice pitch, and poor voice quality, and it commonly happens~     after radiation therapy for laryngeal cancer. Pulsed dye laser may improve post radiation~     dysphonia.~   "
104609|NCT02198118|"~     Background: Breast cancer is the most common type of cancer among women. Its treatment,~     including radiotherapy (RT), can cause potential complications to be treated by the~     physiotherapy. Objective: To evaluate the effect of domiciliary physiotherapy on the upper~     limb applied during the period of radiotherapy in women submitted to surgical and~     radiotherapy for breast cancer. Study design: This is a prospective randomized controlled~     clinical trial. Methods: Thirty six volunteers were recruited from November 2009 to March~     2012 and they were appraised at three different times: pre-RT, post-RT and 2 months after the~     end of RT. The parameters evaluated were: shoulder range of movement (ROM) and arm~     circumference. They were divided into two groups: CG) control group, submitted only to the~     assessments and SG) study group, submitted to domiciliary physiotherapy.~   "
104610|NCT02198105|"~     Observational registry including patients with peripheral artery disease due to~     femoro-popliteal stenosis or occlusion treated with cutting ballon- and subsequent~     drug-coated-ballon-percutaneous-transluminal-angioplasty (PTA).~   "
104611|NCT02198092|"~     This is an observational, case-control study evaluating the quantitative level of Septin9 in~     plasma pre- and post-colectomy in hereditary colorectal cancer (CRC) syndrome patients~     (Familial Adenomatous Polyposis (FAP), Lynch syndrome (also known as HNPCC), and Multiple~     Adenomatous Polyposis (MAP, also known as MYK/MYH) cases) and genetically related FAP-family~     members as controls and references.~   "
104612|NCT02198079|"~     To determine the prevalence of nontuberculous mycobacterial infection (NTM) in pediatric~     patients with cystic fibrosis in the State fo Florida. HYPOTHESIS: There is high prevalence~     of NTM in CF pediatric population in the State of Florida, and likely higher than in the rest~     of the country.~   "
104613|NCT02198066|"~     The purpose of this study was to determine which of three types of dressings, a dry sterile~     dressing, a metallic silver dressing or an ionic silver dressing provided better patient~     outcomes for the post-sternotomy cardiac surgery patient population. In this prospective,~     randomized controlled trial, the hypothesis was that subjects who received either of the~     silver impregnated dressings would have better outcomes (better wound healing, less~     discomfort, and less incidence of infection). Investigators also evaluated dressing factors~     such as adherence, time for application and ease of use.~   "
104614|NCT02198053|"~     Different antiplatelet drugs played various role in coronary artery disease. The mechanisms~     were unclear. Platelet reactivation maybe was one of major causes. Compared with clopidogrel,~     Ticagrelor is more powerful antiplatelet drug. However, because of increased bleeding and~     dyspnea risk, both loading double dose and following second dose time had potential risk and~     inconvenient in routine clinical work, especially in elective PCI of comparable stable~     patients in Chinese. The benefit and risk should be balanced in such patients. The~     investigators supposed loading single dose and followed by second routine time dose was~     superior to clopidogrel and safer than ticagrelor previously prescribed.~   "
104615|NCT02198040|"~     The aim of this study is to assess the effectiveness of two treatments of Physiotherapy: one~     with joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation~     (PNF), and the other with education sessions and home exercises, for the improvement of the~     ROM, biceps strength, perimeter of arm and the perception of pain in PwH and arthropathy of~     the elbow.~   "
104626|NCT02197897|"~     Evaluate the treatment of tamoxifen of low/intermediate-risk bladder tumors~   "
110532|NCT02120664|"~     This study is designed to demonstrate the conversion of florbetapir (18F) Positron Emission~     Tomography (PET) Standard Uptake Value ratio (SUVr) to Centiloid units.~   "
104617|NCT02198014|"~     This study aims to assess the effectiveness of two Physiotherapy treatments: one with manual~     therapy using joint traction, passive muscle stretching, and isometric exercise, active~     resisted and proprioception exercises; and other treatment with educational sessions and home~     exercises to improve the ROM, muscle strength and proprioception in patients with haemophilia~     and arthropathy of the knee.~   "
104618|NCT02198001|"~     This prospective study will include patients taking or having taken bisphosphonates and~     needing dental extractions.~      The aim of this study is to validate the contribution of PRF (Platelet Rich Fibrin) in tooth~     extraction sites.~      In the test group (PRF) and in the control group (no PRF), we use the same atraumatic~     extraction protocol associated with the same antibiotic procedure.~   "
104619|NCT02197988|"~     The purpose of this study is to compare two standard methods of pain control management used~     at Spectrum Health for patients undergoing major surgery. The two methods being compared are~     the thoracic epidural and the TAP block. The thoracic epidural method involves medication~     being given through a patient's back and the TAP block involves medication being given~     through a patient's abdomen (belly). The investigators will compare side effects experienced~     by the patients that take part in this study, including a change in blood pressure, as well~     as the patients' opinions about their pain management experience after surgery.~   "
104620|NCT02197975|"~     Safety and Pharmacokinetics of Two Doses of PT010 in Healthy Adult Subjects of Japanese~     Descent Following a Single Dose and After Chronic Dosing for 7 Days.~   "
104621|NCT02197962|"~     The objective of this study is to compare the results of 2000 impulses of radius shockwaves~     per week with 2000 placebo shockwaves on the treatment of pain and functional incapacity of~     patients with severe primary knee osteoarthritis, who did not satisfactory respond to~     previous conventional treatments.~   "
104622|NCT02197949|"~     At present, patients diagnosed of a breast cancer with infiltration of the axillary~     lymph-nodes are submitted to axillary lymph-node dissection (ALND). The sentinel node (SN)~     technique is not indicated when a lymph-node biopsy or cytology is positive, nor when the~     surgical treatment is upfront neither when a neoadjuvant systemic therapy is indicated. The~     reason for not performing SN is that patients diagnosed of an infiltrated axilla though~     ultrasound-guided biopsy or cytology tend to have a higher tumoral load than those diagnosed~     after a sentinel biopsy. Furthermore, even if these patients are submitted to a neoadjuvant~     systemic treatment and the axillary clinical exploration is negative after the treatment,~     different studies showed that the SN false negative rate is unacceptably high.~      Despite these facts, a high proportion of patients with a positive axilla at diagnosis and~     submitted to level I and II axillary lymph node dissection show few lymph nodes infiltrated~     in the pathological study, frequently four or less neoplastic nodes. New methods of detecting~     these patients with limited infiltrated nodes should be developed and new approaches to~     axillary surgery (i.e., partial resection) should be offered.~      To date, the only information expected to get after an axillary imaging is performed is if~     the axilla is infiltrated or not. No information about the tumoral load is demanded. In the~     other hand, level I and II ALND is performed according to established anatomic limits,~     without selecting the nodes to be excised neither identifying the ones infiltrated for a~     directed excision.~      The aim of the study is to evaluate the ability of a specified and reproducible imaging~     protocol for distinguishing patients with a high axillary tumoral load from the ones with a~     low tumoral load. At the same time, as the initial nodes receiving lymph drainage should be~     the ones commonly affected, identifying these nodes injecting diluted methylene blue in the~     retroareolar parenchyma and studying their tumoral load could help selecting patients with~     high from those with low axillary tumoral load.~      Evaluation of both steps (that is, first the imaging protocol followed by the methylene blue~     protocol), could eventually help to distinguish which patients should be submitted to a~     classical level I and II ALND and which ones can be spared from excising the lymph nodes not~     stained by the methylene blue.~   "
104623|NCT02197936|"~     Spontaneous contractions (peristalsis) of the non-pregnant uterus is widely investigated and~     the role of correct peristalsis is most important for correct sperm transport towards the~     fallopian tubes and implantation of the embryo, thus obtaining pregnancy. At the same time,~     an impaired uterine peristalsis is discussed to be the reason for lower pregnancy rates and~     may also account for heavy menstrual bleedings and menstrual pain.~      In this study, the uterine peristalsis of women with adenomyosis will be investigated. This~     condition is associated to heavy menstrual bleeding, menstrual pain and infertility.~   "
104624|NCT02197923|"~     Adenomyosis is characterized by the appearance of endometrial cells in the muscular layer of~     the uterus. It affects about 15-20% of the female population.~      The symptoms of adenomyosis are heavy menstrual bleedings and painful menstruation~     (dysmenorrhea) and in addition chronic pelvic pain. Subfertility and infertility have been~     correlated with adenomyosis.~      Parity, age and uterine abrasion increase the risk of adenomyosis. Hormonal factors such as~     local hyperestrogenism and elevated levels of prolactin (PRL) have been identified, but~     autoimmune and mechanical factors are also hypothesized.~      Regarding treatment, the most effective measure is hysterectomy. As this is a very drastic~     measure in younger women, levonogestrel-releasing intrauterine devices, Gonadotropin~     releasing hormone (GnRH)-analogues, Danazol, uterine embolization and endometrial ablation~     have been tried, but studies are few in number, retrospective, and have small sample sizes.~      Adenomyosis has so far not been subject to extensive research efforts. The pathogenesis of~     adenomyosis remains still unclear, there are not many satisfying treatment options and~     diagnostics include mostly magnetic resonance imaging (MRI) and histology.~      The investigators designed a series of 3 studies with a broad approach in understanding~     adenomyosis. This is part 2.~      In this study the investigators take both tissue samples and blood samples that will be~     investigated in order to understand the basic processes leading to adenomyosis.~   "
104625|NCT02197910|"~     In this study we will assess the effects of bioactive peptide rich wheat products on blood~     pressure and estimated cardiovascular disease risk. This will be a pilot, explorative,~     cross-over, randomized double-blind 2 groups x 2-arms controlled, clinical trial. The~     intervention will be based on commercially-packaged pasta, which will appear and taste the~     same; (i) low dose bioactive peptides vs. (ii) high dose bioactive peptides. Inclusion~     Criteria will be: Male and female non-diabetic adult volunteers at increased estimated CV~     risk (ESC/EAS SCORE) with SBP 130-139 mmHg and/or DBP 85-90 mmHg); Age included between 40~     and 70 years old; Primary prevention for CVD but otherwise in good general health and have~     had no major illness in the previous 6-months; Volunteer providing their signed and dated~     informed consent form. Exclusion Criteria will be: Severe medical illness/chronic~     disease/gastrointestinal pathology (e.g. coeliac disease); Secondary prevention for CVD;~     Treatment with drugs potentially affecting BP (including antihypertensive drugs) or other~     related CV risk factors; Consumption of nutraceuticals, botanical extracts or other vitamin~     supplements; Volunteer diagnosed as being hypertensive A total of 60 participants will be~     recruited and following adherence to a standardized diet for a 4-week period, will be~     randomly assigned to complete one of 2 treatment sequences by consuming a prescribed quantity~     of pasta products for a 4-week period followed by a 4-week washout before random assignment~     to the 2nd treatment.~      The Primary Outcome will be the modification of office blood pressure (assessed by systolic~     and diastolic BP, pulse and mean pressure (mean of 3 standing & sitting measures) and 24-hour~     blood pressure.~      Additional outcomes include: Anthropometric parameters (Weight, WC, HC, WC/HC, ICO, BMI),~     Glucose and Lipid profile (TC, LDL-C, HDL-C, TG, non-HDL cholesterol, risk ratios), Estimated~     CVD risk changes (EAS/ESC SCORE Charts), Measures of vascular health (FMD, PWA, PWV, Aix),~     Liver and renal functionality biomarkers, 24-h urine collection at baseline of treatment~     phase 1 and endpoint of the final phase will be analysed to account for potential confounding~     of urinary sodium excretion (intake) As required by the GCPs and GLPs, all the SOPs have~     already been established and all the personnel to be involved in the study is continuously~     trained in trials with similar outcomes~   "
104628|NCT02197871|"~     Insufficient energy intake and systematic inflammation lead to malnutrition in patients with~     chronic obstructive pulmonary disease (COPD). Nutritional supplementation improves the~     patients'nutritional status by increasing energy intake and providing anti-inflammatory~     elements，which can relieve the patients' symptoms and delay the disease progression.~   "
104629|NCT02197858|"~     During general anesthesia the basic non-invasive monitoring of hemodynamic parameters (blood~     pressure, O2-saturation, cardiogram) is crucial. It can be enhanced to so called extended~     hemodynamic monitoring depending on the operation and patient. Frequently an invasive~     arterial cannula is used to provide continuous information on the blood pressure. This~     invasive method is very accurate and clinically established, but can be linked to adverse~     effects e.g. reduction of the circulation flow distal of the canulla, haematoma, infection~     etc. ccNexfin (Edwards Lifescience) is a finger cuff measuring the blood pressure in a~     non-invasive manner. It thus offers beat-to-beat information even about the extended~     hemodynamic parameters as cardiac output (CO), cardiac index (CI), stroke volume (SV), stroke~     volume index (SVI) and stroke volume variation (SSV), if connected to the clinical platform~     EV1000 (Edwards Lifescience).~      Assuming that the two methods are equal we plan to measure extended hemodynamic parameters~     before, during induction and during ongoing anesthesia both invasive and non-invasive. Data~     will be recorded every 30sec.~      Clinical evaluation of the ccNexfin technology in respect to extended hemodynamic parameters~     is to our knowledge rare and further assessment in this field is needed to offer patients a~     potentially equally reliable but less invasive monitoring. Furthermore the study should model~     the effect of remifentanil, propofol or its combination on haemodynamics .~   "
104630|NCT02197845|"~     Multi-phase, patient navigator-based program in the Richmond and Tidewater regions of~     Virginia to demonstrate:~        1. the feasibility of using patient navigators to improve the percentage of children and~          adult (age 15 and older) patients with sickle cell disease (SCD) in SCD specialty care~        2. the efficacy of using patient navigators to improve hydroxyurea (HU) (re-)initiation and~          adherence among adult patients with SCD eligible for HU~      (Patient navigators may also be known as public health workers.)~   "
104631|NCT02197832|"~     This is a randomised controlled trial on the effect of endometrial injury in the cycle~     preceding the frozen-thawed embryo transfer (FET) cycles. The study hypothesis is that~     endometrial injury will increase the ongoing pregnancy rate in FET cycles.~   "
104632|NCT02197819|"~     Shoulder dislocations are quite common, the prevalence over a lifetime being estimated at 2%~     in the general population. In young patients, recurrence after a primary dislocation is also~     common (~60%) and multiple recurrent episodes can cause significant disability over time.~     Following initial reduction of the joint, the traditional treatment for primary shoulder~     dislocations has been immobilization in a sling, with the arm in a position of adduction and~     internal rotation. The length of the immobilization period is controversial, however most~     authors would recommend between three to six weeks in a sling followed by several months of~     rehabilitation to include range of motion and strengthening exercises. The clinical course of~     patients after this approach has been extensively investigated. Of particular interest is the~     relatively high rate of recurrent instability in young patients, reported to be between 17~     and 96%.~      A prospective randomized trial is needed to determine whether in young patients (16-30 yrs of~     age) following reduction of a first-time traumatic anterior shoulder dislocation, does~     EMERGENT (<4 hours post reduction) immobilization of the affected shoulder in external~     rotation reduce the rate of recurrent instability experienced within 12 months versus~     emergent immobilization in a traditional internal rotation sling? Eligible patients will be~     randomly allocated to the sling or ER brace. The results of this study will provide the best~     evidence for choosing emergent immobilization for shoulder dislocations.~   "
104633|NCT02197806|"~     A study to evaluate the safety and efficacy of AGN-199201 alone, AGN-190584 alone and~     concurrent use of AGN-199201 and AGN-190584 in patients with presbyopia (inability to focus~     for near vision).~   "
104634|NCT02197793|"~     The purpose of this study is to evaluate the impact of a community mobilization intervention~     on the uptake of HIV testing, linkage to and retention in HIV care using a community, cluster~     randomized trial.~   "
104635|NCT02197780|"~     RATIONALE:~      A substantial proportion of children and teenagers with suspected inflammatory bowel disease~     (IBD) referred for endoscopy do not have the disease. The investigators designed a clinical~     decision rule that included a calprotectin stool test to discern which patients require~     further investigations. The accuracy of this diagnostic strategy is 88.5% with a low risk of~     missing IBD cases. Although the number of negative endoscopies was reduced after introduction~     of this strategy, still 22% of the referred children and teenagers underwent an unnecessary~     invasive test. S100A12 (calgranulin C) is a cytoplasmic protein secreted exclusively by~     activated neutrophils and this stool marker may be more IBD-specific than calprotectin.~      OBJECTIVE:~      To determine whether the specificity of S100A12 is superior to the specificity of~     calprotectin without sacrificing sensitivity~      HYPOTHESIS:~      Inclusion of the calgranulin C stool test will improve the specificity of the~     screening-strategy.~   "
104636|NCT02197767|"~     Will use of Rituximab reduce proteinuria over a 12 month period and will there be~     preservation of kidney function with the use of this study drug?~   "
104637|NCT02197754|"~     There are two primary objectives to be addressed in this study: to assess the differential~     response in bioavailability and metabolic pathways between lean and obese individuals exposed~     to acute, short term (14 day), and long-term (10-week) consumption of polyphenol-rich fruits~     (berries and apple), and beverages (tea); and to determine the differential systemic and gut~     anti-inflammatory response between obese and lean individuals exposed to polyphenol-rich~     fruits (berries and apple), and beverages (tea).~   "
104665|NCT02197390|"~     Our Choice is one of three CORD (Childhood Obesity Research Demonstration) studies funded by~     the Centers for Disease Control and Prevention in 2011 to test multi-sector, multi-level~     approaches to prevent and control childhood obesity. Our Choice is translating evidence-based~     approaches for modifying behaviors, policies, systems, and environments to promote fruit and~     vegetable consumption, physical activity, water consumption, and quality sleep. The ultimate~     goal is to assist Children's Health Insurance Program-eligible children between 2-12 years~     old attain a healthy weight. In addition to site-specific intervention and evaluation~     activities, Our Choice is working with the University of Houston Evaluation Center to conduct~     a cross-site evaluation on a set of shared measures.~   "
104638|NCT02197741|"~     An additional, intermittent bolus application in patients with intrathecal opiate~     administration for chronic pain syndrome may have a positive effect on the effectiveness of~     the treatment. Thus, the effect of an additional, intermittent bolus application in patients~     with intrathecal opiate administration was therefore investigated.~      Patients already equipped with an intrathecal opiate pump were enrolled into the study. Each~     patient was submitted to two treatment periods in randomly chosen order (cross-over design):~     1. standard treatment (continuous opiate administration) and 2. continuous opiate~     administration with intermittent opiate bolus application. Both treatment periods lasted 14~     days. Patients were asked to record pain intensity, side effects and satisfaction with the~     treatment.~      The following hypotheses were tested:~        -  The application of additional opiate boli results in significantly lower pain intensity.~        -  The application of additional opiate boli does not result in a higher rate of adverse~          Events.~   "
104639|NCT02197728|"~     We hypothesize, that the use of the Hohl manipulator® at total laparoscopic hysterectomy~     reduces operative time (from skin incision to detachment of the uterus) and lateral termal~     damage of the vaginal wall during colpotomy due to the following reasons: (1) Uterine~     manipulation is better with the Hohl manipulator®, thereby facilitating dissection during all~     aspects of the surgery, (2) more tension can be applied on the vagina during colpotomy,~     thereby hastening electrosurgical transection, reducing activation time and reduce lateral~     thermal damage and (3) tension on the vagina can be applied until the colpotomy is finished,~     due to the tight connection between the Hohl manipulator® and the cervix of the uterus, which~     also affects speed of transection, electrosurgical device activation time and lateral thermal~     damage.~   "
104640|NCT02197715|"~     This study will develop and initially evaluate Sex and Female Empowerment (SAFE), an~     intervention designed to increase acceptance of and adherence to contraceptive practices~     among opioid-agonist-maintained women of childbearing age. The intervention will be delivered~     in one of two formats: a face-to-face brief intervention approach or a novel~     computer-adaptive platform. To the extent that either version of SAFE is found to be~     efficacious compared with usual care, it has the potential to reduce the number of unintended~     pregnancies and consequently decrease the need for and the costs of child protective~     services.~   "
104641|NCT02197702|"~     In this 7-month randomized controlled trial, children aged 1-6 years with asthma attacks~     triggered mostly by colds, will receive a high dose of vitamin D or a placebo every 3.5~     months during their usual clinic visit. This study will test whether children receiving a~     high dose of vitamin D have less frequent and less severe asthma exacerbations compared with~     those receiving placebo.The study will also document the safety profile of this strategy.~   "
104642|NCT02197689|"~     Taiwan has attracted much attention for its National Health Insurance (NHI) and healthcare~     system around the world with many countries in Europe and the United States using it as a~     benchmark. However, increasing medication costs over the past two years account for more than~     25% of total expenditure, surpassing every OECD member and mounting increasing pressure on~     the NHI. Nevertheless, patient medication adherence is relatively low. Thus, the~     investigators assessed the effectiveness of a personalized medication management system for~     improving the medication adherence for patients, in order to save long term medication costs.~   "
104643|NCT02197676|"~     Treatment of patients with WHO defined IPSS int 2 and high risk MDS , AML with 20-30% marrow~     blasts and CMML type 2, after failure of azacitidine or decitabine exposure for at least 6~     courses, or relapse after initial response.~   "
104644|NCT02197663|"~     The lifestyle of Taiwanese people has been changed over the past decade with the improvement~     of economic growth, environmental sanitation and the quality of medical care. Now the~     investigators pay more attention to the increasing risk of people's diseases of civilization~     than people's malnutrition and poor quality of environmental sanitation. The cerebrovascular~     accident (CVA) leads to death and bio-psycho-social dysfunction. The medical care of the~     patient of cerebrovascular accident cause a lot of money and is a burden of our country.~      Our study emphasizes that acupuncture change bio-psycho-social aspects of the patient with~     cerebrovascular accident. The investigators use some scales to assess efficacy of~     acupuncture, such as Barthel index, National Institute of Health Stroke Scale, Visual~     Analogue Scale, Instrumental Activities of Daily Living and Hamilton Depression Rating Scale.~      Besides, the investigators notice that there are few journals about acupuncture effect of~     treating depression following cerebral vascular accident. The investigators may underestimate~     the amount of people having post-stroke depression. So the investigators use Hamilton~     Depression Rating Scale to Assess the post-stroke depression of cerebral vascular accident~     patient.~      By assessing bio-psycho-social level of CVA patient, the investigators hope this study will~     offer them more Holistic Health Care.~   "
104645|NCT02197650|"~     Early Access Program to provide L-asparaginase encapsulated in Erythrocyte (GRASPA®) for~     patient unable to receive any other form of Asparaginase.~   "
104646|NCT02197637|"~     The purpose of this study is to determine whether oral vinorelbine is effective in the~     treatment of children with progressive or recurrent unresectable low grade glioma.~   "
104647|NCT02197624|"~     The two specific aims of this study are: 1) to assess the impact of a genetic variant on iron~     status; 2) to assess the impact of a genetic variant on non-heme absorption among Asian~     women. The investigators hypothesize that the genetic variant could enhance iron status and~     iron absorption in Asian women.~   "
104648|NCT02197611|"~     Research project for the development, construction and validation of a questionnaire of~     adherence to treatment in adult patients with hemophilia. It aims to build a scale according~     to five relevant dimensions of adherence to treatment: 1) physician-patient relationship, 2)~     knowledge of the disease, 3) previous bleeding problems, 4) knowledge of future consequences~     and difficulties, and 5) benefits of treatment.~   "
104649|NCT02197598|"~     The purpose of this study is to explore the treatment effects of Selincro in alcohol~     dependent patients with liver impairment.~   "
104650|NCT02197585|"~     To compare fixation with glubran2 with suture during surgery por primary inguinal hernia.~      Hypothesis: Glue may induce less complications and chronic pain than suture~   "
104651|NCT02197572|"~     The purpose of this study is to characterize the effect of a single dose of 40 mg MLN0128 on~     the electrocardiographic QT/QTc interval in participants with advanced solid tumors.~   "
104653|NCT02197546|"~     Stimulation of acupoint LI4 has been shown to result in analgesic effects in patients~     experiencing acute pain. We aimed to determine whether LI4 acupuncture could reduce pain and~     distress in children receiving an injection of a local anaesthetic (LA). Children scheduled~     for dental treatment using local anesthesia as a standard treatment, received bilateral~     acupuncture at LI4 using indwelling fixed needles. During the treatment, the parents of the~     patients stimulated the needles by massage. Two different treatment regimes were compared: a~     standardized LA injection given 5 minutes after acupuncture, and an LA injection without~     acupuncture. The order of treatment was randomised, with the two treatments performed on~     different days. Pain intensity during LA injection, assessed by the patient with the Verbal~     Rating Scale or Faces Pain Scale (0-10), was used as the primary endpoint. Parent- and~     dentist-assessed pain intensity and agitation, heart rate, and the patients' satisfaction~     with the received therapy were also recorded.~   "
104654|NCT02197533|"~     Background: Overactive bladder (OAB) is a common condition among postmenopausal women,~     requiring a multifaceted treatment approach that requires patient retention of information~     given to them in clinic. Recall of recommendations is a key component of compliance.~     Supplemental educational tools such as handouts and audiovisual information have been~     investigated for their ability to improve patients' recall of information and increase~     satisfaction with the clinical encounter.~      Objective: To determine if a written list of seven management strategies for overactive~     bladder leads to improved immediate and delayed recall of these recommendations in~     postmenopausal women presenting with OAB compared to a traditional verbal discussion.~      Methods: In this single-blind, randomized controlled trial, patients' immediate and delayed~     (2-week) recall of seven OAB management strategies will be compared between two groups. The~     intervention group will receive a handwritten list during their verbal discussion of OAB~     treatment while the control group will receive standard care (verbal discussion only).~     Immediate and delayed recall will be assessed by a member of the study team who has been~     blinded to participants' group assignments.~      Results: The results of this study may guide clinicians in the most effective mode of~     providing treatment recommendations to post-menopausal patients with OAB.~   "
104655|NCT02197520|"~     This study will look into insulin sensitivity (how the body responds to insulin) and effects~     of meals on type 2 diabetics comparing insulin peglispro to insulin glargine. The study has~     two treatment periods, each of which will last about four weeks. One drug (insulin peglispro~     or insulin glargine) will be administered in each period. Participants will receive both~     drugs during the study. Participants may remain on stable dose metformin, as prescribed by~     their personal physician.~   "
104656|NCT02197507|"~     Rheumatoid arthritis (RA) is the most common chronic inflammatory arthritis in adults.~     Monitoring of disease activity is based on Disease Activity Score 28 (DAS 28). There are also~     validated questionnaires for self-assessment of the disease by the patient. Grip strength~     measured using a digitized sensor used by the patient could be an additional tool to the~     remote monitoring of patients with RA.~      Main Objective : To evaluate the correlation between the measurement of grip strength in the~     dominant hand measured by a digital sensor and activity of RA assessed by DAS 28~      Secondary objective : Evaluate the correlation between grip strength of the dominant hand and~     :~        -  scores of fatigue and pain (VAS and FACIT)~        -  the self-assessment scores known in RA : functional index Health Assessment~          Questionnaire (HAQ) and scores of activity RAPID3 and RADAI5.~      It is a cross-sectional study involving 150 patients followed in our department for RA. Grip~     strength of the dominant hand will be measured by a digitalized sensor during a single visit~     integrating into the routine monitoring of patients.~   "
104657|NCT02197494|"~     The study was an open label, balanced, randomized, two-treatment, two-period, two sequence,~     single oral dose, crossover, bioequivalence study of two formulations of Valsartan 320 mg~     under fed conditions.~   "
104658|NCT02197481|"~     The purpose of this study is to compare short-term and long-term efficacy of BiClamp forceps~     hepatectomy and clamp-crushing technique for parenchymal transection during elective hepatic~     resection.~   "
104659|NCT02197468|"~     Necrotizing enterocolitis (NEC) is a leading cause of morbidity and mortality among infants~     in the neonatal intensive care unit (NICU). It has been postulated that abnormal colonization~     of the preterm gut, or an unfavorable balance between gut bacteria may contribute to the~     development of NEC.~      Recent clinical randomized studies and meta-analysis have shown that proactive colonization~     of probiotic bacteria reduce the frequency of NEC. Based on this evidence, in April 2014 all~     Norwegian NICUs started routinely administration of probiotics to all extremely premature~     neonates susceptible to NEC (gestational age <28 weeks/birth weight <1000g).~      The current project is investigating the gut microbiome in patients receiving probiotics and~     compare the the gut microbiome with moderate premature infants not receiving probiotics. In~     addition, we are including a control of healthy full-term infants.~      Samples containing feces from participants will be analyzed by state of the art whole-genome~     sequencing techniques. Bacterial diversity will be analysed with bioinformatic tools.~      Study hypotheses:~        -  Probiotics given to extremely preterm infants will change the biodiversity of the gut~          microflora.~        -  Antibiotics given to these patients may influence the gut microflora also in infants~          receiving probiotics. In particular use of vancomycin may change the gut flora.~        -  After cessation of probiotic prophylaxis the gut flora of infants receiving probiotics~          will gradually resemble the gut flora of infants not receiving probiotics.~        -  A cross-contamination of probiotic bacteria between patients treated with probiotics and~          patients not treated with antibiotics may occur.~   "
104660|NCT02197455|"~     The purpose of this study is to investigate the ability of tofacitinib citrate, a Janus~     kinase inhibitor, to generate hair regrowth in patients with moderate to severe alopecia~     areata and its variants.~   "
104661|NCT02197442|"~     The study was an open label, balanced, randomized, two-treatment, four-period, two sequence,~     single oral dose, crossover, fully replicate bioequivalence study of two formulations of~     Valsartan 320 mg under fasting conditions.~   "
104662|NCT02197429|"~     A randomized controlled pilot study was conducted to evaluate the effect of an acupuncture~     protocol for the treatment of vulvodynia.~      Hypotheses:~        1. Acupuncture reduces vulvar pain and dyspareunia in women with vulvodynia.~        2. Acupuncture increases sexual function in women with vulvodynia.~   "
128538|NCT01884948|"~     To study the efficacy and safety of intravenous Omegaven™ (vs. Placebo) in reducing~     postoperative morbidity and mortality after major liver resection.~   "
104666|NCT02197377|"~     With an aging population a prevalence of edentulous patients increased above 60 % among~     individuals aged ≥65 yr. Face mask ventilation of these edentulous patients is often~     difficult because of the inadequate fitting of the standard mask to the face. In addition,~     because of a reduction in muscle tone under general anesthesia, the air space in the~     oropharynx is reduced, and posterior displacement of the tongue, soft palate and epiglottis~     tend to close the airway. The laryngeal mask airway (LMA) provides a better alternative to~     the standard face mask if the facial contours of the patient are not suited to the standard~     face mask. It is more difficult to perform bag-mask ventilation in edentulous patients than~     in patients with intact dentition. The laryngeal mask airway (LMA) provides a better~     alternative to the standard face mask if the facial contours of the patient are not suited to~     the standard face mask.~      We aimed to compare the routinely used laryngeal mask airway in our clinic, the LMA Unique™~     with the newly released LMA Supreme™ in edentulous elderly patients for the success in first~     attempt insertion, ease and time of insertion, and oropharyngeal leak pressure.~   "
104667|NCT02197364|"~     The purpose of the study is to evaluate the significance of KL-6 as a biomarker in the~     clinical diagnosis of interstitial lung disease (ILD) by detecting serum KL-6 levels among~     patients with ILD, and comparing them to the clinical diagnostic criteria and other~     respiratory diseases. In addition, the study discusses the value of KL-6 levels in terms of~     ILD treatment effect evaluation through the detection of serum KL-6 levels before treatment~     and after treatment.~   "
104668|NCT02197351|"~     It is thought that the development of cancer of the stomach follows a series of stages in~     which the lining becomes increasingly abnormal. Early detection of precursors of gastric~     cancer likely enable less invasive treatment.~      The assessment of gastric mucosa using the endoscope is used to detect cancers and these~     precursor lesions. Narrow band imaging uses filtered light already built into modern~     endoscopoes to identify the early changes in the gastric lining.~      The investigators' hypothesis is that narrow band imaging improves detection of precursor~     lesions and is a method amenable to international standardization.~      The investigators will conduct a prospective trial in which standard random biopsy, white~     light guided biopsy, and narrow band imaging guided biopsy will be performed for each~     patient. The yield of the different methods for gastric cancer precursors will thus be~     compared.~   "
104669|NCT02197338|"~     1. Cannulation of (placement of a small catheter into) the bile duct is critical to remove~          bile duct stones, divert bile leaks, and decompress biliary obstruction due to cancer.~        2. Given the small size of the bile duct orifice and its close proximity to the pancreatic~          duct, selective biliary cannulation is the most difficult part of the endoscopic~          retrograde cholangiography (ERCP).~        3. New small diameter sphincteromes and short wire systems (which allow physicians to~          control guidewires) offer potential, though untested advantages.~        4. At most hosptial both the long and short wire systems as well as small versus standard~          are routinely used for clinical care.~        5. Our hypothesis is that small diameter, physician controlled wires favor biliary~          cannulation~        6. Our objective will be to assess whether small diameter sphincterotomes and short wire~          physician controlled guidewire cannulation favors successful bile duct cannulation and~          minimize complications.~   "
104670|NCT02197325|"~     The purpose of this research study is to find out whether PICSO (Pressure Controlled Coronary~     Sinus Occlusion), given concomitant to (NSTEMI) or following (STEMI) primary PCI and~     stenting, can improve final infarct size and myocardial function.~      ACS patients, NSTEMI and STEMI, with a culprit lesion in the LAD will be treated according to~     standard treatment, PCI followed by stent placement, with or without PICSO therapy. In NSTEMI~     patients, PICSO therapy will be given during PCI and stenting for a minimum of 30 minutes or~     the duration of the PCI and stent procedure. In STEMI patients PICSO therapy will be given~     after successful primary percutaneous coronary intervention of a left anterior descending~     coronary artery culprit lesion. PICSO therapy is initiated prior to stent deployment and~     continued during stenting. The functional efficacy measures, related to the PICSO duration~     and coronary sinus pressures, will be stored on the PICSO Impulse console and analysed~     offline. The clinical efficacy measures, cardiac enzyme release during 24 hour following PCI,~     cardiac function, infarct size and level of microvascular obstruction will be assessed by~     cMRI. Patients will be followed for a maximum of 4 months after the primary PCI procedure~   "
104671|NCT02197312|"~     Industrial centrally produced 3- or 4-unit bridges of shaded yttrium-oxide~     partially-stabilized (Y-TZP) zirconia (NobelProceraTM Shaded Zirconia) in combination with a~     veneering ceramic material will show sufficient CDA ratings and a sufficient survival rate~     after 5 years~   "
104672|NCT02197299|"~     A characteristic of Type 2 diabetes is a high blood glucose level, which is partly caused by~     the inability of insulin to stimulate glucose uptake into our muscles (insulin resistance).~     Insulin resistance can be caused by the accumulation of fat within muscle of overweight~     individuals. The aim of the present research is to test whether a novel nutritional~     intervention containing L-carnitine can increase the amount of carnitine within muscle of~     individuals recently diagnosed with Type 2 diabetes. Carnitine is essential for 'burning fat'~     within our muscles and it is hoped that increasing the amount of carnitine within muscle can~     increase fat burning, lower muscle fat, reverse insulin resistance and ultimately lower blood~     glucose levels and wellbeing. We also aim to investigate the cellular mechanisms underlying~     any observed effects in a hope to identify further targets to lower muscle fat.~   "
104673|NCT02197286|"~     A ten week, blinded trial of vitamin D vs. placebo in 80 patients with schizophrenia or~     schizoaffective disorder who have low blood levels of vitamin D and elevated blood levels of~     the amino acid proline. The aims of the study are to evaluate an anticipated clinical~     response to vitamin D supplementation including negative symptoms and cognitive deficits,~     evaluate safety of vitamin D supplementation for schizophrenia patients and evaluate the~     relationship of changes in plasma proline levels and efficacy outcomes.~   "
104674|NCT02197273|"~     The purpose of this study is to determine whether liposomal bupivacaine is effective in the~     management of pain following total joint arthroplasty, as compared to standard of care~     analgesia.~   "
104727|NCT02196584|"~     Hypothesis: The RAVI-Guide provides superior patient acceptability to the conventional lid~     speculum during intravitreal injections~      Aims: To compare patient acceptance and procedural complication rates of the RAVI-Guide with~     those of the conventional lid speculum and caliper approach~   "
104675|NCT02197260|"~     It is common practice to carry out the therapy of periodontal diseases in two phases. In a~     first, non-surgical phase, bacterial deposits on tooth surfaces (plaque and calculus) are~     removed using a cleaning method called scaling and root planing (SRP). After three to six~     months the case is evaluated and, if necessary, further treatment is provided, usually taking~     a more aggressive, surgical approach. Beneficial effects of adjunctive systemic antibiotics~     on clinical outcomes have been shown repeatedly but specific indications for antibiotics in~     subgroups of diseased patients, and the optimal timing of antimicrobial therapy, continue to~     be issues of a long lasting controversy.This study assessed the differential outcomes of~     periodontal therapy supplemented with amoxicillin-metronidazole during either the~     non-surgical or the surgical treatment phase.~   "
104676|NCT02197247|"~     This is a Phase I, open-label, 2-part study in patients with a confirmed diagnosis of~     epidermal growth factor receptor (EGFR) mutation positive (EGFRm+) non-small cell lung cancer~     (NSCLC), who have progressed following prior therapy with an approved EGFR tyrosine kinase~     inhibitor (TKI) agent.~      Part A will assess the effect of rifampicin on the pharmacokinetic (PK) parameters of AZD9291~     and metabolites AZ5104 and AZ7550 following multiple oral dosing of both rifampicin and~     AZD9291 in a fasted state.~      Part B will allow patients further access to AZD9291 after the PK phase (Part A) and will~     provide for additional safety data collection. All patients who complete Part A will be able~     to enter part B, and continue to receive AZD9291 80 mg once daily until: disease progression;~     they are no longer deriving clinical benefit; or any other reason.~   "
104677|NCT02197234|"~     This is a Phase I, open-label, 2-part study in patients with a confirmed diagnosis of~     epidermal growth factor receptor (EGFR) mutation positive (EGFRm+) non-small cell lung cancer~     (NSCLC), who have progressed following prior therapy with an approved EGFR tyrosine kinase~     inhibitor (TKI) agent.~      Part A will assess the effect of AZD9291 on the pharmacokinetic (PK) parameters of~     simvastatin and simvastatin acid, following multiple oral dosing of AZD9291 in a fasted~     state.~      Part B will allow patients further access to AZD9291 after the PK phase (Part A) and will~     provide for additional safety data collection. All patients from Part A who completed~     treatment may continue to receive AZD9291 80 mg once daily until: disease progression; they~     are no longer deriving clinical benefit; or any other reason.~   "
104678|NCT02197221|"~     Phase III multicenter randomized, open-label study comparing the efficacy of a combined high~     dose chemotherapy using melphalan and bortezomib versus melphalan alone followed by stem cell~     transplant in frontline multiple myeloma patients, non-progressive after induction therapy.~   "
104679|NCT02197208|"~     This is a randomized controlled trial on the comparison of the ongoing pregnancy rate in~     frozen-thawed embryo transfer cycles with spontaneous ovulation and hCG-induced natural~     cycles.~   "
104680|NCT02197195|"~     The purpose of the study is to understand the role chocolate milk compared to a fruit drink,~     with and without exercise, on glycaemic regulation and subjective appetite in children. The~     investigators hypothesize that chocolate milk in combination with exercise will have the~     greatest effect attenuating glycaemic response. Blood glucose will be measured by finger~     prick following drink consumption (0 min) and exercise or sitting (15 min), and at 65~     minutes. Subjective appetite will be measured at 0, 20, 35, 50 and 65 minutes.~   "
104681|NCT02197182|"~     LUXSOL Cream may be useful for the treatment of bacterial Vaginosis. In this study, LUXSOL~     Cream is compared to a control arm group using metronidazole cream. LUXSOL is administered~     intravaginally for 10 days, each evening before bedtime to treat bacterial Vaginosis..~   "
104682|NCT02197169|"~     Glioblastoma (GBM) and gliosarcoma (GS) are the most common and aggressive forms of malignant~     primary brain tumor in adults and can be resistant to conventional therapies. The purpose of~     this Phase Ib study is to evaluate how well a recurrent glioblastoma or gliosarcoma tumor~     responds to one injection of DNX-2401, a genetically modified, conditionally replicative and~     oncolytic human-derived adenovirus. DNX-2401 is delivered directly into the tumor where it~     may establish an active infection by replicating in and killing tumor cells.~   "
104683|NCT02197156|"~     The purpose of the study is to establish a dose-response relationship among several capsule~     strengths of Hydrocodone Bitartrate Extended Release (HC-ER) and to compare the efficacy to~     placebo following bunionectomy surgery~   "
104684|NCT02197143|"~     -  Currently, Proton Pump Inhibitors and H2Receptor Blockers are widely used by emergency~          physicians in Turkey for the treatment of patients with dyspepsia.~        -  The objective of the study was to assess whether intravenous esomeprazol has superior~          dyspeptic pain reduction compared with ranitidine or hydrotalcid in emergency department~          (ED) adults~        -  The investigators second aim was to compare recurrent dyspeptic pain within 24 hours~          after discharge and cost of treatments in the treatment of dyspepsia.~   "
104685|NCT02197130|"~     This study is a 26 week, randomized, parallel group, double blind comparison of PF-02545920 5~     mg, PF-02545920 20 mg, and placebo dosed BID in the treatment of motor impairment of subjects~     with Huntington's Disease. A total of approximately 260 subjects are planned to be randomized~     in the study. Primary endpoint is the change from baseline in the Total Motor Score (TMS)~     assessment of the Unified Huntington Disease Rating Scale (UHDRS) after 26 weeks of~     treatment. secondary endpoints will include change from baseline in the Total Maximum Chorea~     (TMC) score of the UHDRS after 13 and 26 weeks of treatment and Clinical Global~     Impression-Improvement score after 13 and 26 weeks of treatment.~   "
104698|NCT02196961|"~     Primary Objective:~      To estimate the efficacy of adjuvant nivolumab monotherapy in completely resected Merkel cell~     carcinoma (MCC) patients; i.e. the primary endpoint is disease-free survival (DFS) in arm A~     at 12 months, defined as the number of patients alive and free of disease at 12 months after~     randomization compared to DFS in arm B.~      Secondary Objectives:~      To assess safety and additional efficacy parameters of the ipilimumab or nivolumab treatment~     in MCC, as well as to characterize potential biomarkers; secondary endpoints are: (i) adverse~     events according to CTCAE (Common Terminology Criteria for Adverse Events), Version 4.0~     criteria, that are definitely, probably, or possibly related to the administration of~     ipilimumab, (ii) Overall survival rate at 12 months, defined as the number of patients~     surviving at 12 months after randomization divided by the total number of patients~     randomized, (iii) DFS rate at 12 months, defined as the number of patients alive and free of~     disease at 12 months after randomization divided by the total number of patients randomized.~   "
104686|NCT02197117|"~     New treatments are required to improve health outcomes in patients with ischemic heart~     disease. This is especially so in developing countries such as Mauritius in which optimal~     therapy for acute myocardial infarction may not be widely available. For example for patients~     presenting with a heart attack (caused by a blockage in one of the heart blood vessels) the~     treatment of choice would be to remove the blockage by primary percutaneous coronary~     intervention (PCI) using an angioplasty balloon and put a stent (a spring-like structure) to~     keep the artery opened. However, PCI is not widely available in Mauritius and heart attack~     patients are given clot-busting therapy to remove the blockage, but this is not as effective~     as PCI.~      Therefore, in this research study we investigate a new cheap treatment that may help protect~     the heart against damage during a heart attack, called remote ischemic conditioning (RIC), in~     which a blood pressure cuff is placed on the upper arm and inflated for 5 minute and deflated~     for 5 minutes a cycle which is repeated 4 times in total in patients presenting with a heart~     attack. By temporarily depriving oxygen and nutrients to the arm with the blood pressure cuff~     a protective signal can be relayed to the heart to reduce the amount of damage occurring~     during the heart attack and thereby prevent the onset of heart failure.~      Study hypothesis: Remote ischaemic conditioning will reduce the amount of damage occurring to~     the heart muscle during a heart attack..~   "
104687|NCT02197104|"~     The objective of this study is to determine if citocoline is effective for balance~     abnormalities and to stabilize cognitive decline in patients with fragile X-associated tremor~     ataxia syndrome. The study will test 1000mg twice daily of citocoline for 12 months in an~     open label pilot study, with study visits at baseline, 3, 6, and 12 months.~   "
104688|NCT02197091|"~     This pilot research trial studies communication effectiveness in cancer treatment. Studying~     how well patients and their doctors communicate about the treatment being given for cancer~     may help improve the decisions that patients and physicians make together.~   "
104689|NCT02197078|"~     This protocol is for a series of comparative effectiveness and safety analyses within~     periodically updated cohorts of patients initiating linagliptin, other DPP-4 inhibitors, and~     other oral hypoglycemic medications, followed longitudinally for the occurrence of a variety~     of health outcomes. The primary analysis will be conducted among patients without prior~     within-class medication use.~   "
104690|NCT02197065|"~     Up to 35% of hip fracture patients have been shown to experience heart injury after surgery,~     and as many as 10% have a heart attack or die in the three months after surgery. Hip and knee~     arthroplasty patients are also at risk of cardiovascular complications. Patients who have~     these complications have higher levels of inflammation postoperatively. Statins (such as~     atorvastatin/Lipitor) lower cholesterol and also lessen inflammation. Both of these effects~     are important in preventing heart attacks. Statins have been shown to reduce the risk of~     heart attacks in non-surgical patients, and to protect from heart attacks in patients having~     heart surgery. Whether statins can prevent heart attacks in orthopedic patients is not known.~      In this pilot study the investigators will treat 30 orthopedic surgery patients (hip~     fracture, hip or knee arthroplasty) with either atorvastatin or placebo (a capsule with no~     study drug). Patients will start the study drug prior to surgery and take it for 45 days~     after surgery. Neither the doctors nor the patients will know whether they are taking~     atorvastatin or placebo. The investigators will look for evidence of inflammation and heart~     injury after surgery. The investigators hypothesize that atorvastatin will lessen the degree~     of postoperative inflammation found in these patients. In this study, the investigators will~     use a very sensitive test of heart injury that can detect problems even when patients have no~     symptoms. The investigators hypothesize that this test will demonstrate silent heart injury~     in over 50% of the hip fracture patients and over 30% of arthroplasty patients in our study.~      The results of this trial will help us to develop a larger study in 1000 hip fracture and~     joint replacement patients to determine whether atorvastatin protects orthopedic surgery~     patients from heart injury and other complications of surgery.~   "
104691|NCT02197052|"~     The goal is to better understand the social needs of a population seeking care in a large,~     urban children's hospital emergency department with a large Medicaid population. Consenting~     English and Spanish-speaking adult caregivers will be randomized to social screening via a~     face -to-face interview with a trained bilingual researcher or via a self-completed~     tablet-based survey. We hypothesize that there will be no difference in disclosure rates~     between the two screening formats for items other than highly sensitive items. For highly~     sensitive items we hypothesize disclosure rates will be higher for the self-completed~     tablet-based survey.~   "
104692|NCT02197039|"~     The purpose of this prospective study is to identify risk factors which could predict poor~     fading of SRH or early recurrent bleeding of peptic ulcer hemorrhage after successful~     endoscopic hemostasis and high-dose PPI infusion. These risk factors will be the selection~     criteria for patients who are indicated to receive second-look endoscopy.~   "
104693|NCT02197026|"~     Comparison of treatment cost of knee osteoarthritis (OA) in patients treated with Synvisc®~     versus usual treatments as well as evaluation of safety and effectiveness of these~     treatments.~   "
104694|NCT02197013|"~     Incidence and time of occurrence of blood leakage with the closed intravascular catheter~     Introcan Safety 3 in comparison to Introcan Safety~   "
104695|NCT02197000|"~     The purpose of this study is to determine whether adding DIM supplement will decrease breast~     density among female BRCA mutation carriers in two years.~   "
104696|NCT02196987|"~     Currently, there are no specific guidelines or best practice suggestions for best male~     catheterization as fat as insertion technique. There is however, information as to reducing~     infection, and as to recommended lubricant.~      From our experience, the investigators have noticed that when requesting the patient to~     attempt urination while inserting a urethral catheter, the level of pain and discomfort is~     reduced. In this study, the investigators will evaluate the pain level during male urethral~     catheterization in each technique.~      Our hypothesis is that the level of pain will be much less if the in the study group where~     the act of urination will be requested from the patient.~   "
104697|NCT02196974|"~     In patients with peripheral lung nodules, what is the additional diagnostic yield of biopsies~     obtained with flexible cryoprobes compared to standard techniques? For patients with~     peripheral nodules, we hypothesize use of the cryoprobe will allow larger samples of tissue~     to be obtained and therefore, will increase the diagnostic yield over conventional techniques~   "
104699|NCT02196948|"~     Therapeutic management of supraspinatus tendinopathy is conflicting. There is evidence that~     eccentric exercise protocols can be effective for this condition. The inclusion of other~     therapeutic modalities could help to the management of these patients. A new therapeutic~     approach, called Electrolysis Percutaneous Therapeutic (EPTE) has been clinically developed.~     The objective of this randomized clinical trial is to determine the effectiveness of the~     inclusion of EPTE into a eccentric exercise protocol for the management of patients with~     unilateral supraspinatus tendinopathy~   "
107082|NCT02165761|"~     To characterize the GORE® Hybrid Vascular Graft as compared to non-heparin bonded synthetic~     vascular grafts in terms of the prevalence and persistence of anti-platelet factor 4 /~     heparin antibodies (anti-PF4 / H antibodies).~   "
104700|NCT02196935|"~     Endoscopic retrograde cholangiopancreatography and endoscopic ultrasound are increasingly~     being used to manage complex disease of the bile duct, pancreas and cancer. Gastroenterology~     patients at the Los Angeles County Hospital presents a unique and diverse patient population.~      Our aim is to study the biochemical, radiographic, and clinical predictors of bile duct~     stones. Exploratory aims include the study of the management of cholangitis, bile leaks, GI~     cancer diagnosis and management, and the management of pancreaticobiliary problems in the~     underserved.~      All patients managed by EUS or ERCP at the LA County & USC University Hospitals will be~     enrolled in the databaseThe timing, clinical presentation, and objective details of patient~     presentation are recorded prospectively. Additionally the results of the subsequent ERCP and~     EUS procedures. Subsequent, clinical course and pathology will also be recorded.~   "
104701|NCT02196922|"~     In the US, racial and ethnic disparities persist, even when income, health insurance and care~     access are addressed. For example, there is a greater prevalence of chronic heart failure~     (CHF), higher rates of hospital use and higher death rates in blacks as compared to whites.~     This is due to many factors including: reduced healthcare access, higher prevalence of~     hypertension,coronary artery disease, systolic dysfunction, myocardial infarction and~     obesity. Given the magnitude of this chronic health issue, the growth of the elderly~     population, and increases in ethnic diversity, providers need to develop new ways of caring~     for those with chronic conditions living in health disparity communities.~      The investigators propose to implement a randomized study with health disparity~     community-dwelling patients. A bilingual clinician will follow patients for 3 months after~     hospitalization for CHF to test this approach for the proposed health disparity population.~     The investigators will obtain patient/caregiver input at multiple points during the research~     to make necessary adjustments to the intervention to ensure that disparity patients~     accept/use the system, and are satisfied. To ensure that proposed outcomes have relevance for~     patients, a Community Advisory Board (CAB) of stakeholders will advise the study team~     throughout the study process. The investigators believe that studying patient use of TSM over~     a 3 month period will: 1) identify cost-effective care approaches for patients living with~     chronic disease; 2) involve the patient in identifying and testing approaches that work for~     them; 3) enhance provider-patient communication; 4) teach the patient how to self-monitor and~     explore his/her role in self-care; 5) improve patient education about treatment options and~     6) explore how usable the patients feel the program is. If our goals are achieved, these~     strategies will result in patient-led improvements in health, satisfaction and quality of~     life. Knowledge gained will further understanding of the use of telehealth programs as~     effective self-management tools.~   "
104702|NCT02196909|"~     The objective of the study is to identify the best clinical and biological outcome measures~     for further therapeutics approaches.~   "
104703|NCT02196896|"~     The purpose of this study is to determine the acceptance and efficacy of the online self-help~     program deprexis® for depressed patients in reducing the clinical symptoms of their~     depression. The patients of the experimental group use deprexis® for 90 days, the patients of~     the placebo group receive weekly online information about depression for 90 days as well.~     Both groups receive their treatment in addition to their regular inpatient psychosomatic~     treatment and as an aftercare intervention.The investigators hypothesize that the online~     self-help group achieves a greater reduction of depression compared to the control group.~   "
104704|NCT02196883|"~     Patients are being asked to participate in a research study because the patients are being~     treated for low back pain and the patients have decided to have an epidural steroid~     injection.~      Low back pain has a tremendous impact on the individual and society. It not only affects the~     individuals quality of life, it also contributes to lost productivity and increased health~     care costs.~      Epidural steroid injections (ESIs) are a common treatment option for many forms of low back~     pain. They have been used for low back problems since 1952 and are still being used as a~     non-surgical form of treatment for low back pain. The goal of the injections is reduction of~     pain, increased quality of life and improved function.~      This study is being conducted to determine the outcomes of injections given at the level of~     MRI Pathology versus at the level of clinical symptoms to see if one is more effective~     than the other and to learn more about the characteristics of the two different injections.~   "
104705|NCT02196870|"~     Patients with chest wall elastance increasing could worsen lung function. Increasing of chest~     wall elastance plays a great role in lung mechanics, and could influence mechanical~     ventilation settings. Therefore, It could help the physicians to find appropriate indicators~     and optimize the treatments of ARF patients to explore the mechanisms of lung mechanics~     changse in the patients with high chest wall elastance.~   "
104706|NCT02196857|"~     The goal of this clinical research study is to learn if 5-azacitidine and sorafenib can help~     to control the disease in patients with AML and high risk MDS with FLT3-ITD mutation. The~     safety of this drug combination will also be studied.~   "
104707|NCT02196844|"~     The goal of this behavioral research study is to learn the opinion of patients and their~     caregivers about a couple-based Hatha Yoga program (Group 1) during treatment for cancer.~     Researchers also want to learn the effect of this program on lung function, distress,~     biological function, and quality of life. For comparison purposes, there will also be a group~     of participants (Group 2) that does not take part in this program.~      You and your caregiver/family member will have about a 50/50 chance of being assigned to each~     group. The groups are randomly assigned, but it is also based on other factors such as your~     age and the status of the disease.~   "
104708|NCT02196831|"~     Liver disease is one of the leading co-morbidities of human immunodeficiency virus (HIV)~     infection, and nonalcoholic fatty liver disease (NAFLD) is present in approximately 30-40% of~     patients with HIV infection. Nonalcoholic steatohepatitis (NASH) is a more severe form of~     NAFLD in which increased liver fat is also accompanied by inflammation, cellular damage, and~     fibrosis.~      NAFLD is most prevalent in patients who also have increased visceral adiposity, and our group~     has previously shown that HIV-infected individuals with increased visceral adiposity~     generally have decreased growth hormone secretion. Tesamorelin is a growth hormone releasing~     hormone (GHRH) analogue that increases endogenous growth hormone secretion. Tesamorelin is~     FDA-approved for the reduction of visceral fat in HIV-infected individuals. In a previous~     study, treatment with tesamorelin in HIV-infected individuals selected for abdominal~     adiposity reduced liver fat. The current study is designed to test the effect of tesamorelin~     on liver fat and steatohepatitis in HIV-infected individuals who have NAFLD. The~     investigators hypothesize that tesamorelin will reduce liver fat and will also ameliorate the~     inflammation, fibrosis, and hepatocellular damage seen in conjunction with NASH.~   "
104709|NCT02196818|"~     This is a multi-centre, prospective post marketing surveillance study to assess mid-term~     performance of the Mpact cup in subjects requiring primary total hip arthroplasty.~   "
112261|NCT02098057|"~     The overall hypothesis of this research study is that gluten intake alters intestinal barrier~     function in patients with Irritable Bowel Syndrome (IBS) diarrhea who also exhibit non-celiac~     gluten sensitivity (NCGS).~   "
104712|NCT02196779|"~     Abdominoplasty is a common cosmetic operation. Some investigators believe that the risk of~     complications is reduced by limiting the operative dissection. However, this can compromise~     the quality of the result. This study was undertaken to investigate the blood supply of the~     abdominoplasty skin flap during surgery using laser fluorescent imaging. An imaging agent is~     injected and the fluorescence is recorded using a near-infrared laser. The blood supply is~     tested after a limited dissection and then after a traditional dissection to determine~     whether an extended dissection reduces the skin circulation. The study hypothesis is that~     there is no difference in blood supply and the traditional abdominoplasty does not compromise~     skin circulation.~   "
104713|NCT02196766|"~     To determine if patients are unreactive to the lens care solution / Biofinity combination.~   "
104714|NCT02196753|"~     The aim of this single-center randomized controlled trial is to assess clinical usefulness of~     positron emission tomography combined with computed tomography (PET CT) in the diagnostic~     process of suspected cardiovascular implantable electronic device (CIED) infection (lead~     dependent infective endocarditis, generator pocket infection, fever of unknown origin).~   "
104715|NCT02196740|"~     The triple antibiotic paste is widely used in young permanent teeth and permanent teeth root~     canal therapy with excellent antiantimicrobial effect.We hypothesize that its application in~     the treatment of periapical periodontitis of deciduous teeth is superior to other drugs~     currently in use as creosote.~   "
104716|NCT02196727|"~     The purpose of this study is to evaluate postoperative pain in Bascom Cleft Lift operation~     receiving multimodal analgesia in day-case surgery setting.~      Hypothesis: Multimodal analgesia provides adequate pain relief in patients undergoing Bascom~     Cleft Lift operation.~   "
104717|NCT02196714|"~     A Randomized, Double-Blind, Single-Dose, Four-Period, Four-Treatment, Cross-Over,~     Single-Center, Phase I, Crossover Study in Healthy Japanese Adult Subjects to Evaluate the~     Safety and Pharmacokinetics of Two Doses of PT003 and Two Doses of PT001.~   "
104718|NCT02196701|"~     The purpose of this study is to determine the safety and efficacy of the use of the~     combination therapy adalimumab (ADA) every other week (EOW) with methotrexate (MTX) in~     suboptimal responders to ADA monotherapy.~   "
104719|NCT02196688|"~     Fruquintinib administered at 5mg once daily in 4 weeks treatment cycle (three weeks on and~     one week off) was well tolerated and demonstrated encouraging preliminary clinical antitumor~     activity in patients with advanced CRC in phIb study.~      This study is aimed to evaluate the efficacy and safety of Fruquintinib in the treatment of~     patients with metastatic CRC who have progressed after metastatic CRC second line or above~     standard chemotherapy.~   "
104720|NCT02196675|"~     Collection of real world outcomes of Video-Assisted Thoracoscopic Surgery (VATS) for lung~     cancer (lobectomy, wedge resection) using ECHELON FLEX™ Powered ENDOPATH® Staplers 45 mm~     and/or 60 mm (study devices) in a Korean population.~   "
104721|NCT02196662|"~     The primary objective of this study is to compare the rate and extent of absorption of~     mesalamine-sodium hyaluronate 200 mg-28.75 mg delayed-release capsule (IBD98-M, Test) versus~     Delzicol 400 mg delayed-release capsule (mesalamine Reference), administered as a single oral~     dose of 2 x 200 mg-28.75 mg delayed-release capsule (total dose of 400 mg-57.50 mg) or 1 x~     400 mg delayed-release capsule under fasting conditions.~   "
104722|NCT02196649|"~     Patients will be randomised to have endoscopic clips applied to the Endoscopic Mucosal~     Resection (EMR) site following complete removal of the lesion, or will not receive clips and~     proceed with standard of care.~   "
104723|NCT02196636|"~     This two-part study will assess the safety and tolerability of single ascending oral doses of~     RO6806127 in a group of healthy male participants and investigate the effect of high fat and~     high caloric food on the relative bioavailability of a single oral dose of RO6806127 in a~     separate group of healthy male participants. The relationship between drug exposure and~     tolerability will be explored.~   "
104724|NCT02196623|"~     Ageing is the primary risk factor for most chronic diseases including type 2 diabetes~     mellitus. Sarcopenia and muscular mitochondrial dysfunction with aging are crucial mechanisms~     leading to decreased exercise tolerance and worsened insulin sensitivity. Thus, metabolic~     disease and frailty, which limits physical mobility as well as quality of life, share common~     cellular mechanisms.~      The investigators will test the hypothesis that a combination of normobaric hypoxia and~     exercise training elicits a synergistic effect on age-associated metabolic skeletal muscle~     dysfunction and the investigators will address the molecular mechanisms. In a randomized~     clinical study, the investigators will compare normoxic and hypoxic training conditions in~     elderly subjects. Outcome measures will focus on whole body insulin sensitivity and~     mitochondrial responses in skeletal muscle before and after the 8-week training intervention.~   "
104725|NCT02196610|"~     People with kidney failure have a higher chance of getting disease in the blood vessels and~     this result in a decreased elasticity of the arteries of their body which make them very~     stiff or hard. It appears that stiffer arteries with a decreased elasticity increase the risk~     of stroke and heart disease. A novel way to know the stiffness of blood vessels is by a~     method called applanation tonometry, which measures the pulse wave velocity of major~     blood vessels such as the aorta, carotid and femoral arteries. The purpose of our study is to~     determine if we can measure arterial stiffness reliably and accurately using this method in~     healthy people and in people with kidney failure receiving hemodialysis treatments at our~     centre. Also, we would like to know how stiff these arteries in healthy people are. If we~     demonstrate that the method is reliable and accurate in these 2 groups of participants at our~     centre, a future larger study is planned to determine if we can use measures of arterial~     stiffness to evaluate the risk of stroke and heart disease in people with kidney failure~     receiving hemodialysis. The research study will take place at the Ottawa Hospital-Riverside~     Campus.~   "
104726|NCT02196597|"~     Background: High prevalence of fecal incontinence after rectal resection in patients with~     rectal carcinoma.~      Hypothesis: Anorectal manometry done before ileostomy or sigmoidostomy closure can predict~     fecal incontinence.~      Methods: Anorectal manometry before, 1 month and 6 month after closure. Anorectal~     endosonography before and 1 month after closure. Prediction of postoperative incontinence by~     the surgeon (digital sphincter examination). Visual analog scales for continence, subjective~     success of operation, and global well being; Wexner and Vaizey incontinence score; Parks~     incontinence classification; Rockwood fecal incontinence quality of life score; each before,~     1 and 6 month after closure.~   "
104728|NCT02196571|"~     Gestational diabetes mellitus (GDM) is defined as impaired glucose tolerance of various~     degrees first manifested during pregnancy. The primary aim of treating GDM is to optimize~     glycaemic control and improve pregnancy outcomes. Also, as part of treatment, it is~     recommended to continue or initiate exercising with moderate intensity. However, available~     data on the effects of physical activity on GDM are based on a small number of trials. The~     aim of the trial is to examine and add new scientific evidence on possible health-related~     effects of application of structured programme consisting of aerobic and resistance exercises~     on the course and outcomes of GDM. Primary goal of research is to determine how proposed~     exercise programme effects glycaemic control, rate of complications during pregnancy, labour,~     delivery, immediate after delivery and health status of newborn. Main hypothesis is that~     parameters of glycaemic control, course of GDM, complications during delivery and birth~     outcomes directly and significantly correlate with participation in structured programme of~     exercise. Research will be conducted as experimentally designed randomized controlled trial.~     Participants will be pregnant women diagnosed with GDM, age between 20 and 40, without~     comorbidities. Women in the experimental group will be included in exercise programme two~     times per week with duration of 50 minutes. Training sessions will start right after the~     diagnosis and will be performed until the end of the pregnancy. The training protocol will~     follow international guidelines (ACOG, 2001; ACOG, 2002; ADA, 2008; NICE, 2008; ADA 2011).~     Women in the control group will receive standard medical care.~   "
104729|NCT02196558|"~     This study consist of treatment phase (12 weeks) and extension phase (40 weeks). This study~     is a multicenter, open-label, uncontrolled, multiple ascending dose (MAD) study to evaluate~     mainly the safety and tolerability of 12-week repeated subcutaneous administration of E6011~     in Japanese subjects with Rheumatoid Arthritis. First 12 subjects will enroll as 100 mg~     group, next 12 subjects will enroll as 200 mg group, and last 9 subjects will enroll as 400~     mg group. A total of 33 subjects will receive repeated subcutaneous administration of E6011.~     Subjects who roll over onto the Extension phase will have continued monitoring until 52 weeks~     after the initial administration.~   "
104730|NCT02196545|"~     The purpose of this study is to determine if a home based physical activity training program~     for patients with Alzheimer's dementia has effects on clinical and neurobiological~     parameters.~   "
104731|NCT02196532|"~     Optical coherence tomography (OCT) is a non-invasive retinal imaging technology that can~     provide high-resolution cross-sectional images of the peripapillary retinal nerve fiber layer~     (RNFL) and measure its thickness. A reduction of the RNFL thickness has been detected in~     several neurodegenerative diseases, such as multiple sclerosis, CADASIL and Alzheimer's~     disease. Different studies have reported RNFL changes also in migraine, is a common~     hereditary chronic neurovascular disorder, characterized by dysfunction of the autonomic~     nervous system. The pathophysiology of migraine has not been fully clarified, but there is~     increasing evidence that episodes of migraine with aura are initiated by a focal reduction in~     cerebral blood flow, which occurs most commonly in the posterior region of one hemisphere.~     Although vasoconstriction of cerebral and retinal blood vessels is a transient phenomenon,~     the chronic nature of the migraine might cause permanent structural abnormalities of the~     brain and also of the retina, which may correlate with RNFL thinning. Previous studies on~     this subject, however, reported contradicting results. Some investigations reported~     reductions of the RNFL thickness while others did not. In the present study, in order to~     determine whether RNFL thickness is reduced in migraine patients, the investigators performed~     a meta-analysis and systematically evaluated RNFL thickness measurements with OCT in a series~     of migraine patients and in the healthy control groups.~   "
104732|NCT02196519|"~     A first in human study evaluating the safety of Sylys Surgical Sealant in protecting the~     anastomotic junction created during a stoma reversal procedure.~   "
104733|NCT02196506|"~     The purpose of this study is to assess the tolerability, safety, and efficacy of~     brexpiprazole (2.0 mg/day) as adjunctive therapy in adult subjects with a diagnosis of MDD~     with and without anxious distress~   "
104734|NCT02196493|"~     We have noticed a group of patients presenting with a longstanding wet cough which has often~     been treated as asthma. The cough is productive of sputum which frequently contains bacteria,~     but does not resolve with standard antibiotic treatment.~      A very similar cough is seen in subjects who smoke, have exposure to airbourne dusts or~     chemicals or have a condition known as bronchiectasis, but these problems have already been~     excluded.~      We have found that prolonged treatment with an antibiotic called azithromycin is very~     effective but using azithromycin in this way is not licensed and there is currently no trial~     evidence to support its use.~      This research will evaluate the clinical benefit of low dose azithromycin to determine if~     this is an effective and safe treatment for these patients. It will also involve a detailed~     investigation of these patients to determine whether they have enough in common to believe we~     are describing a new condition.~   "
104735|NCT02196480|"~     Objectives: To assess immunogenicity and safety of the 23-valent polysaccharide pneumococcal~     vaccine (PPV23) in JIA patients with and without anti-TNF therapy. The influences of~     demographic data, disease activity and treatment on immune response and the potential~     deleterious effect of vaccine on disease itself were also evaluated.~      Methods: 17 JIA patients immediately pre-etanercept (Group 1) and 10 JIA patients on stable~     dose of methotrexate (Group 2) will receive one dose of PPV23. All patients will be evaluated~     pre-vaccination, 2 months and 12 months post-vaccination for seven pneumoccocal serotypes.~     Serology will be performed by enzyme immunoassay and the immunogenicity endpoints will~     include seroprotection (SP), seroconversion (SP) and geometric mean concentration of~     antibodies (GMC). Clinical and laboratorial parameters of JIA will be evaluated before and~     after vaccination.~   "
104766|NCT02196077|"~     This is a Phase IIb, randomized, double blind, chronic dosing (28 days), four period, five~     treatment, incomplete block, crossover design in subjects with moderate to severe COPD. The~     overall objective is to demonstrate that the combination of budesonide (BD; PT008) and~     formoterol fumarate (FF; PT005) in a metered-dose inhaler (MDI); (BFF MDI; PT009) provides~     benefit on lung function compared with BD MDI in subjects with moderate to severe COPD.~   "
104767|NCT02196064|"~     To evaluate the incidence of grade 3 or 4 transaminase elevations or grade 4 total bilirubin~     elevations (hepatic toxicity) during the first 48 weeks of antiretroviral therapy with the~     combination of rilpivirine (25mg), tenofovir (245mg) and emtricitabine (200mg), in a~     single-tablet regimen (Eviplera®) in human immunodeficiency virus (HIV)/hepatitis C virus~     (HCV)-coinfected subjects.~   "
104736|NCT02196467|"~     This Phase I/II of the clinical trial is to investigate whether the transplantation of normal~     myoblasts throughout one muscle (the extensor carpi radialis) of the patients is safe and~     will improve the strength of that muscle. During this Phase I/II, the patients will be~     transplanted with myoblasts grown from the muscle biopsy of a donor and kept frozen in liquid~     nitrogen. Thirty million myoblasts will be injected per cm cube in a progressively higher~     surface of the radialis (i.e., 3, 6 and 9 cm2). The contralateral muscle will be injected~     with saline to serve as a control. The strength of both muscles will be measured at 3 months~     post transplantation to verify whether the myoblast transplantation improved the strength of~     the muscle. If there is no significant strength improvement, the protocol will be terminated~     immediately for that patient. If there is a significant strength improvement, the patient~     will be maintained under immunosuppression until 6 months post transplant and his strength~     will be re-evaluated.~   "
104737|NCT02196454|"~     The purpose of this research study is to determine if video-based education will increase HPV~     vaccination rates among 11 - 17 year olds.~   "
104738|NCT02196441|"~     General anaesthesia now a days is not the first choice in phakic intra ocular lens surgery~     (Phakic IOL) , the short duration of the surgery, general anaesthesia complications, decrease~     the length of hospital stay and decreasing the costs direct the interest to the regional~     anaesthesia By the time the traditional retro and peribulbar injections recede to a newer~     techniques that is safer and cheaper, sub tenon's block using a blunt needle took over due to~     the more safety profile Even though, still serious problems can occur specially in patients~     with long axial length.~      Deep topical fornix nerve block anaesthesia (DTFNB) and topical anaesthesia gradually took~     over with promising and successful results, decreasing length of hospital stay and increasing~     patient satisfaction and fewer margins of complications.~      In this study the investigators compared topical anaesthesia alone with DTFNBA in patients~     undergoing posterior chamber phakic IOL surgery (Visian ICL).~   "
104739|NCT02196428|"~     The aim of this study is to explore the requirements and conditions of medical~     teleconsultation and remote diagnostics (telemonitoring) of older people in the residential~     environment with an emphasis on the need for adaptation, feasibility and acceptance of~     telemedicine services to a web based documentation and communication platform (Ambient~     Assisted Living Wizard).~   "
104740|NCT02196415|"~     -  The measurement of hindfoot alignment is a technical challenge.~        -  Today, hindfoot alignment is typically measured on hindfoot alignment view radiographs~          or long axial view radiographs. Measurements on both types of radiographs are hampered~          by technical shortcomings such as minimal rotational misplacement of the foot at the~          time of image acquisition. In previous publications our study groups demonstrated~          substantial measurement errors due to these shortcomings as well as bad interreader~          agreement.~        -  Hindfoot alignment measurement is feasible on MR images but hampered by the~          non-weight-bearing position of the patient and therefore not suited for pre-treatment~          evaluation.~        -  In an ex vivo study using plastic phantoms of a foot our research group could~          demonstrate superior interreader agreement and complete correction for foot misplacement~          at the time of image acquisition using a 3D secondary measurement technique based on~          biplanar low dose radiographs.~        -  Image acquisition using biplanar low dose radiographs is associated with a substantial~          reduction (about 1/7) of radiation dose applied to the patient compared to standard~          radiographs.~        -  Therefore the question arises if these excellent ex vivo results can be confirmed in a~          prospective clinical study.~      Objectives:~        1. Evaluation of technical feasibility of 3D hindfoot alignment measurements based on~          biplanar radiographs.~        2. Reproduction of superior interreader agreement of measurements based on biplanar~          radiographs compared to measurements on conventional radiographs.~   "
104741|NCT02196402|"~     Several reports have suggested that an endoscopic diagnosis of adenoma, by means of narrow~     band imaging (NBI), might allow the determination of polyp management and surveillance~     interval, particularly in patients with diminutive polyps (< 5mm), in which the advanced~     histological features are uncommon and the prevalence of invasive cancer is negligible (1).~     On this basis, the American Society of Gastrointestinal Endoscopy (ASGE) has set an~     initiative evaluating the applicability of real-time endoscopic polyp assessment in clinical~     practice (1), which states that:~        1. for diminutive polyps to be resected and discarded without pathologic assessment,~          endoscopic technology (when used with high confidence) used to determine histology of~          polyps < 5mm in size, when combined with the histopathologic assessment of polyps >5 mm~          in size, should provide a > 90% agreement in assignment of post-polypectomy surveillance~          intervals when compared to decisions based on pathology assessment of all identified~          polyps.~        2. In order for a technology to be used to guide the decision to leave suspected~          rectosigmoid hyperplastic polyps <5 mm in size in place (without resection), the~          technology should provide > 90% negative predictive value (when used with high~          confidence) for adenomatous histology~      This strategy could potentially exert a significant impact on colonoscopy practice, by~     decreasing at some extent pathology-associated costs, although those related to histological~     analysis of >5mm polyps is maintained.~      In a recent study performed in our Centre (2), we restricted the application of the resect~     and discard strategy to patients with small or diminutive polyps only, achieving an~     accordance between endoscopy-directed and histology-directed surveillance strategy of about~     85% in both populations. This approach, where decisions on patient management are driven only~     by the in vivo endoscopic assessment, provides on one hand a slightly lower accordance than~     the threshold of 90% set by the PIVI, but on the other one it allows the complete spare of~     pathology related costs, although for a smaller proportion of patients. Moreover we observed~     a negative predictive value of 86% for the presence of adenoma within the diminutive polyps~     cohort, although a separate analysis for left sided ones was not performed.~      AIms of this single center, prospective, observational study:~        1. To prospectively evaluate the accordance between the endoscopy-directed and~          histology-directed surveillance strategies by applying the resect and discard strategy~          for diminutive polyps according to the PIVI statements~        2. To assess the economic impact of the resect and discard strategy when applied either~          according to the PIVI statements or to restrictedly to subjects with diminutive polyps~          only~        3. To provide a temporary validation of diagnostic performances of the resect and discard~          strategy for our group and the potential presence of a learning effect for the~          methodology~        4. Accordance between endoscopists' and nurses' categorization of adenomas according to~          standardized criteria (see below)~   "
104742|NCT02196389|"~     Several nasal dilators are currently commercially available, and can be applied endonasally~     (Airmax°, Nozovent and Nasanita°) or externally (Breath Right°). An objective comparison~     between these dilators has not been made so far, and would help the clinicians to advise the~     use of any of these dilators. From clinical experience, endonasal dilators are well supported~     and improve breathing better than the external dilators~   "
104743|NCT02196376|"~     In this pilot study, the investigators will test the hypothesis that patients with postural~     tachycardia syndrome will have an elevated percentage of functional antibodies to adrenergic~     receptors compared with control subjects without POTS. The investigators further hypothesize~     that the percentage of POTS patients with antibodies will be higher in those patients with a~     viral infection at the onset of their illness than in those patients with other or undefined~     illness onsets.~   "
104768|NCT02196051|"~     The purpose of this study is to examine the pathophysiology of insulin resistance and the~     relation to the metabolic syndrome in humans.~   "
104744|NCT02196363|"~     Babies that are either very small or very big have increased perinatal morbidity and~     mortality. Predicting which babies will fall into these groups is traditionally done with~     risk assessment and third trimester manual palpation, however neither of these techniques are~     sensitive and a considerable number of affected pregnancies are missed. This results in~     stillbirth for small babies or birth trauma for larger ones. Serial scanning in the third~     trimester can improve detection rates but this is expensive and cannot currently be provided~     to all NHS patients.~      A more sensitive test that can be performed earlier in pregnancy would allow identification~     of at risk pregnancies allowing for increased monitoring. New three dimensional ultrasound~     techniques that measure volume and volumetric flow have become available that may allow this~     to happen. This study proposes to trial newer ultrasound techniques on a cohort of pregnant~     women. The findings from these scans will then be correlated with actual birth weights at the~     end of pregnancy to determine the ability of these parameters to act as screening tools for~     babies at the extremes of size.~   "
104745|NCT02196350|"~     The study aims to assess the impact of the P4 approach on established markers of glucose~     metabolism in type 2 diabetics.~      Secondary objectives are examination of the changes in physical characteristics, quality of~     life and the indices for beta cell function, hepatic insulin resistance and muscle insulin~     resistance .~   "
104746|NCT02196337|"~     The purpose of this study is to determine whether universal salt iodization (USI) meets the~     iodine requirements of pregnant women, lactating women and infants.~   "
104747|NCT02196324|"~     The purpose of this study is to demonstrate whether or not VPD-737, an NK1 receptor~     antagonist is safe and effective for treatment of prurigo nodularis versus placebo.~   "
104748|NCT02196311|"~     Patients treated with circular external fixation will have better outcomes (as measured by~     range of motion (ROM), alignment, outcome surveys) than those treated with open reduction and~     internal fixation (ORIF).~   "
104749|NCT02196298|"~     The Lokomat is a robotic treadmill gait trainer that is used to help people who have~     neurologic conditions walk better. Early research with children with cerebral palsy (CP)~     shows that it may help to improve walking skills. The purpose of this two-group randomized~     study is to compare Lokomat training to regular physiotherapy (PT) as far as impact on~     walking abilities and related function. The primary (alternate) hypothesis is that children~     will improve more with Lokomat training in terms of gross motor skills and walking endurance.~      The investigators are enrolling 40 ambulatory children who are ages 5 to 12 years, have CP~     and are in Gross Motor Function Classification System (GMFCS) Level II (n=20) or III (n=20).~     In this crossover randomized clinical trial (RCT), whether PT or Lokomat intervention is done~     first is decided by an independent randomization process that occurs after the first baseline~     assessment. In the Lokomat phase, children receive 8 to 10 weeks of twice weekly therapy for~     a maximum of 16 sessions. Each session is 35 minutes plus the time needed for set-up. The 35~     minute PT program is also given twice weekly for 8 to 10 weeks for a maximum of 16 sessions,~     and focuses on a menu-based strength, co-ordination, fitness, walking and balance activities.~     There is a 6 week break between the Lokomat and PT interventions.~      Each child has four study assessments during their ~6 months in the study. The first~     assessment is done before starting the Lokomat or physiotherapy phase. The second happens~     after the first intervention has finished. The child then has a 6-week break period. The~     third assessment is done at the end of this break, and the fourth occurs after the second~     intervention. The PT assessor who does these assessments will not be the same as the PT who~     gives the intervention. The assessor is blinded to the child's intervention phase and~     previous assessment results. The primary outcome measures are the Gross Motor Function~     Measure and 6 minute walk test. Secondary measures evaluate gait, functional abilities,~     participation, health related quality of life and individualized goals.~      The randomized aspect of the study lets us look at outcome differences between children for~     Lokomat and PT within their first intervention phase (n=20/group). The cross-over phase~     evaluates within-child outcomes across the two phases. A qualitative component is~     concurrently underway to examine child/parent experiences and their views of Lokomat~     outcomes.~   "
104750|NCT02196285|"~     Measles and rubella are highly contagious acute viral diseases. As per WHO, several evidences~     demonstrate the benefit for providing the universal access to vaccines containing measles and~     rubella antigens, mainly due to, respectively, mortality in children and malformations in~     fetuses. This is a Phase I, open study, non-controlled, to evaluate the safety, tolerability~     and imunogenicity of double viral vaccine anti-measles and rubella (MR), which is developed~     and produced at Instituto de Tecnologia em Imunobiologicos Bio-Manguinhos/Fiocruz, in Brazil,~     for use in human beings. 30 eligible volunteers, between 18-49 years old, will be vaccinated~     and monitored for local and systemic adverse events and titration of antibodies. The study~     will last 20 months in total.~   "
104751|NCT02196272|"~     A number of strategies have been evaluated to improve clinical outcomes in diabetics~     patients, however no studies explored the efficacy of a nurse-led reminder program through~     email (NRP-e) to improve medication adherence, even if it is fundamental in the management of~     diabetics. The study aims at evaluating for the first time the efficacy of a nurse-led~     reminder program through email (NRP-e) to improve medication adherence in diabetic patients.~   "
104752|NCT02196259|"~     Functional connectivity is defined as a correlation in neural activity between distinct~     regions of the brain. Several recent studies have demonstrated areas of low-frequency~     functional connectivity inherent to brain tissue at rest. These oscillations can be measured~     using functional magnetic resonance imaging (fMRI) and appear to be synchronized between~     related areas of the brain.~      To date, no investigators have examined the effects of low-dose anesthesia on functional~     connectivity. This study will image the human brain under conditions of rest, and low-dose~     anesthetic induced sedation. Quality of the acquired signals will be evaluated and functional~     networks in the brain will be examined. Of interest is whether administration of a low-dose~     anesthetic disrupts functional connectivity in the brain, and whether a disruption of~     functional connectivity is responsible for the reported analgesic and antidepressant effects~     of a anesthetic.~      Participation in the study includes four visits: an in-person interview, an initial fMRI~     scan, the anesthesia infusion, and a second fMRI scan. There is an optional follow-up fMRI~     scan one week post infusion.~   "
104753|NCT02196246|"~     To evaluate an iPad based photoimage analysis system (Moletest) for improving discrimination~     of benign from malignant suspicious skin lesions or moles. Specifically the objective is to~     demonstrate that the Moletest system is able with a sufficient degree of confidence (95%) to~     identify lesions which are benign~   "
104754|NCT02196233|"~     Trigger finger is a condition commonly treated with surgical intervention, yet no specific~     incision type has been associated with improved or worsened scar quality or outcome.~     Therefore, the investigators objective is to determine if the incision type may affect the~     results of operative treatment of trigger finger. Therefore, the goals of this study are as~     follows:~      Primary Objective: To directly compare incision type (transverse vs. longitudinal) for~     trigger finger release with scar quality and patient satisfaction via a validated scar~     evaluation scale.~      Secondary Objective: To directly compare incision type (transverse vs. longitudinal) for~     trigger finger release to patient outcome via a validated upper extremity outcome score.~   "
104755|NCT02196220|"~     Mucopolysaccharidosis are lysosomal storage disorders such as Hunter, Hurler, and Sanfilippo~     syndromes. These patients have a genetic enzyme deficiency that results in the inability to~     degrade glycosaminoglycans. The glycosaminoglycans accumulate in lysosomes causing cell~     enlargement and subsequent dysfunction. The accumulation occurs in all tissues including~     cartilage, joint capsule, and tendons and can lead to carpal tunnel syndrome, trigger digits,~     and various other orthopaedic manifestations [Van Heest, White]. These children often suffer~     from severe cognitive impairment and are often unable to communicate pain or numbness. Carpal~     tunnel syndrome is almost always present, but may not become apparent until symptoms are~     severe and loss of function has occurred. The current gold standard for diagnosis consists of~     electromyographic (EMG) and nerve conduction velocity (NCV) studies under sedation or general~     anesthetic [Khanna].~      Primary Objective: The investigators plan to correlate EMG findings and median nerve~     cross-sectional area in children with mucopolysaccharidosis. The investigators hypothesis is~     that ultrasonography of the carpal tunnel in patients with mucopolysaccharidosis will prove~     to be an effective, reliable, and safe method to evaluate the median nerve, thus avoiding the~     need for EMG studies and anesthesia.~      Secondary Objective: The investigators want to determine the cross-sectional area of the~     median nerve using ultrasonography in a cohort of healthy children, ages 3-12. The~     investigators plan to evaluate a cohort of healthy children to determine a normal~     cross-sectional area of the median nerve.~   "
104756|NCT02196207|"~     This study will evaluate if inhibitors are reduced when Eloctate is begun in children with~     severe Hemophilia A before the first bleed (preemptive) and continued weekly to prevent~     bleeds (prophylaxis).~   "
104757|NCT02196194|"~     This prescription-event monitoring study was based upon 'event' monitoring and so capable of~     identifying signals of events that might be associated with the use of tiotropium, which none~     of the participating general practitioners (GPs) suspected to be an adverse drug reaction.~     The methodology of this study readily permits follow up of specific events and the obtaining~     of additional data as appropriate.~   "
104758|NCT02196181|"~     This randomized phase II trial studies how well dabrafenib and trametinib work in treating~     patients with stage III-IV melanoma that cannot be removed by surgery and contains a B-Raf~     proto-oncogene, serine/threonine kinase (BRAF) mutation. Dabrafenib and trametinib may stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
104759|NCT02196168|"~     This randomized phase II trial studies how well cisplatin with or without WEE1 inhibitor~     MK-1775 works in treating patients with head and neck cancer that has come back or has spread~     to other parts of the body. Drugs used in chemotherapy, such as cisplatin, may prevent tumor~     cells from multiplying by damaging their deoxyribonucleic acid (DNA), which in turn stops the~     tumor from growing. WEE1 inhibitor MK-1775 may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth. It is not yet known whether cisplatin is more~     effective with or without WEE1 inhibitor MK-1775 in treating patients with head and neck~     cancer.~   "
104760|NCT02196155|"~     Plantar fasciitis is the classic and most common type of heel pain. Considering the costs for~     health care and the temporary disability not only for work, plantar fasciitis results in a~     substantial (and at least partially unnecessary) burden for the Swiss health care system and~     national economics.~      Nonoperative treatment is the mainstay of treating plantar fasciitis. However, so far no~     treatment has proven to be superior to others, and there is national and international lack~     of consensus of how to treat plantar fasciitis best.~      The investigators believe that the BTX-A injection in the gastrocnemius and the soleus~     muscles is currently the most promising non-operative approach, because it is considered to~     treat the disease at its origin (temporary weakening of the tight triceps surae muscle) as~     opposed to simply alleviate the symptoms (e.g. plantar cortisone and other injections, ESWT).~      However, to date there is no evidence in the literature that compares the new, promising~     technique of BTX-A injection into the gastroc-soleus complex to a sham (saline) injection and~     to the gold standard steroid injection at the plantar fascia insertion site. With the~     intended study, this gap is going to be closed.~   "
104761|NCT02196142|"~     To investigate the effects of cortisol on alcohol craving and stress reactivity in alcohol~     addicted subjects.~      Randomized, double-blind, placebo-controlled, cross-over, single administration of study~     medication.~      Study hypothesis: Cortisol has an inhibiting effect on alcohol craving and stress reactivity~     in alcohol dependent subjects.~   "
104762|NCT02196129|"~     The purpose of this study is to investigate the immediate pain relieving effects of sinbaro-3~     pharmaco-acupuncture in patients with low back pain admitted for inpatient care~   "
104763|NCT02196116|"~     This research aim to explore relationships between the presence of amyloid burden and~     cognitive performance, and its modulation by educational level. For this purpose we will~     combine Positron emission tomography (PET) imaging and neuropsychological assessment acquired~     on 3 groups of subjects, from two population-based cohorts 3C and AMIMage The first group~     includes cognitively intact participants who will serve as controls, the second group,~     subjects with mild cognitive impairments without memory complaint and the third, subjects~     with both mild cognitive impairments and memory complaint.~   "
104764|NCT02196103|"~     Induction of labor in women desiring TOLAC has long been a topic of controversy. The paucity~     of published data on mechanical cervical ripening in the setting of TOLAC and term PROM has~     led us to undertake the present clinical trial.~   "
104765|NCT02196090|"~     Obsessive Compulsive Disorder (OCD) is a condition associated with recurrent intrusive~     distressing thoughts, images and urges compelling the person to perform neutralizing acts or~     thoughts to the extent of significantly interfering with their daily activities. The symptoms~     of OCD are associated with both subjective and objective signs of distress. Treatment for~     Obsessive Compulsive Disorder is often associated with significant subjective distress with~     high dropout rates and often only limited improvement. Attempts to reduce distress in anxiety~     often focus on re-establishing the sympathovagal balance by enhancing the vagal or~     parasympathetic tone and it has been suggested that this can reduce the mobilization~     behaviours of fight or flight response and improve emotion regulation. This study will~     investigate the effect of a procedure potentially reducing distress and improving outcome of~     treatment in inpatients admitted for treatment for OCD to the Anxiety Disorders Residential~     Unit. The procedure will be based on increasing vagal tone by application of cold face mask~     on 3 consecutive days in addition to the standard Exposure and Response Prevention therapy~     (ERP).~   "
104769|NCT02196038|"~     REHAB-HF: A Trial of Rehabilitation Therapy in Older Acute Heart Failure Patients, is a~     multicenter, randomized, attention-controlled, single-blind trial designed to examine the~     hypothesis that, in addition to standard care, a novel, tailored, progressive, multi-domain~     rehabilitation intervention administered to older patients with acute decompensated heart~     failure (ADHF) beginning early during hospitalization and continuing for 12 weeks will~     improve physical function and key clinical outcomes, including the rate of rehospitalization.~   "
104770|NCT02196025|"~     Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation technique that~     has been approved as a treatment of depression in patients that have not responded to a trial~     of one antidepressant medication. The investigators hypothesize that low frequency TMS exerts~     inhibitory effect on hyper excitable cortical state in patients with chronic insomnia and~     therefore is therapeutic. The investigators want to compare the change in insomnia scores~     between baseline and end of treatment in an open label trial with bifrontal low frequency TMS~     stimulation in 20 patients with primary insomnia using daily stimulation of 3 weeks (15 week~     days).~   "
104771|NCT02196012|"~     The purpose of this study is to determine the feasibility and acceptability and efficacy of a~     two month technology-based weight loss program for overweight and obese college students.~   "
104772|NCT02195999|"~     This study seeks to develop and validate non-invasive assessments of cardiac and respiratory~     muscles with magnetic resonance imaging (MRI) to better predict the natural disease~     progression of Duchenne muscular dystrophy (DMD) in affected individuals over time, as well~     as determine whether peripheral skeletal muscle dysfunction can predict cardiopulmonary~     dysfunction. The central hypothesis is that non-invasive MRI measures of the heart, muscle,~     and peripheral skeletal muscles can sensitively predict future cardiopulmonary decline.~   "
104773|NCT02195986|"~     The purpose of this study is to determine the therapeutic equivalence of Mylan's estradiol~     vaginal cream to Estrace® cream and superiority of both products to placebo. The protocol~     describes a randomized, double-blind, multi-dose, placebo-controlled, parallel study of a 7~     day treatment.~   "
104774|NCT02195973|"~     The purpose of this study is to find out if a new drug, LDE225, is safe and has beneficial~     effects when combined with paclitaxel in women with platinum resistant ovarian cancer.~     Platinum resistant ovarian cancer refers to recurrent ovarian cancer that has undergone~     chemotherapy inclusive of a platinum compound (e.g. carboplatin or cisplatin).~   "
104775|NCT02195960|"~     Attention has been focused recently on the development of modalities that can protect healthy~     organs from the harmful effects of radiation applied during different cancer treatment~     schedules. As radiation-induced DNA damage involves oxidative stress, the protective role of~     antioxidants has been tested in different dietary studies. Previous experience by the~     collaborative team of the principal investigator and radiotherapists at the Catholic~     University of Campobasso has shown in a retrospective study that moderate wine consumption~     can reduce the side-effects of radiation therapy in patients with breast cancer. This effect~     was presumably due to the polyphenol non alcoholic fraction of wine, a finding in agreement~     with a cross-over intervention study in adult male volunteers, on protection by~     de-alcoholized red wine from ex vivo radiation-induced DNA damage.~      The purpose of this clinical trial will be to test the impact of supplementation with~     anthocyanin-enriched food on the acute and medium-term side effects of radiotherapy in breast~     cancer patients, in a prospective study design. Therefore a double blind, randomised,~     placebo-controlled clinical trial will be organised by assigning patients with breast cancer~     scheduled for radiotherapy to a diet supplemented with an anthocyanin soluble extract.~   "
104776|NCT02195947|"~     The effect of use of the growth hormone with antagonist protocol on the outcome of the~     IVF/ICSI cycles in poor responders.~   "
104777|NCT02195934|"~     This study aims to compare the effect of an anthocyanin-rich blood orange juice with a~     standard (no anthocyanin) blonde orange juice on markers of cardiovascular disease (CVD).~      Participants aged between 25 and 84 years of age will be recruited into a single arm, two way~     cross-over study based on their waist measurement, with 42 individuals required to complete~     the study. Participants will each receive two interventions in a randomised order: 500mL~     blood orange juice daily for 28 days, and 500ml standard (blonde) orange juice daily for 28~     days.~      Prior to each intervention there will be a 2 week run in period where participants will be~     asked to avoid consuming foods rich in anthocyanins. After the first 28 day intervention~     period, there will be a 3 week wash out period after which the participants will be asked to~     then drink the other juice for 28 days. The 500 mL of blood orange juice contains~     approximately 50mg of anthocyanins, whereas the standard juice contains none.~      Blood samples will be collected for the preparation of plasma and peripheral blood~     mononuclear cells (PBMCs) for the analysis of anthocyanin metabolite concentrations,~     transcriptomics and CVD risk markers. Urine samples will be collected and urinary excretion~     of anthocyanin metabolites will be quantified. Other measurements will include pulse wave~     analysis, pulse wave velocity, central blood pressure, waist and hip circumference, blood~     glucose, glycated haemoglobin (HbA1C) and insulin concentrations, and various measurements~     using the TANITA machine which include weight, fat mass, muscle mass, fat percentage,~     fat-free mass, total body water, bone mass, metabolic age, basal metabolic rate, visceral fat~     rating, and degree of obesity. All measurements and samples will be taken at baseline and~     post intervention for each phase of the study.~   "
104778|NCT02195921|"~     The purpose of this study is to clarify whether the matching acupoints is more effective than~     a single point by electroacupuncture in the management of chemotherapy-induced nausea and~     vomiting .~   "
104779|NCT02195908|"~     The purpose of this study is to clarify whether the matching acupoints are more effective~     than a single point by electro-acupuncture in the management of chemotherapy-induced nausea~     and vomiting .~   "
104780|NCT02195895|"~     The purpose of this study is to determine if a year of alendronate treatment will maintain or~     increase bone mass density (BMD) compared to baseline BMD values in people with chronic SCI.~      This study will also investigate 1) if alendronate therapy will increase bone strength in~     people with chronic SCI, 2) the safety of alendronate, and 3) the effects of alendronate on~     serum markers of bone metabolism.~   "
104781|NCT02195882|"~     The purpose of this study is to determine whether a specific strengthening program for the~     stabilizing scapular muscle can reduce shoulder pain of amateur kayaker.~   "
104784|NCT02195843|"~     Heart failure is the most rapidly growing cardiovascular condition in developed countries.~     Despite advances in medical therapy, patients with heart failure are at high risk for death~     and hospitalization. Cardiac Resynchronization Therapy - defibrillators (CRT-D) are an~     effective treatment for heart failure.~      Despite the high success rate of a CRT-D implant, there is a possibility of 10% that the LV~     lead cannot be implanted in patients undergoing a trans-venous system implantation. In this~     case, the patients may undergo multiple procedures before a lead is successfully implanted.~     These implant failures are not due to patient selection but rather to patients heart anatomy~     leading to lead stability problems, phrenic nerve stimulation (also called diaphragmatic~     stimulation) and poor electrical measurements.~      The phrenic nerve is not part of the heart but runs near to this area on the way to a large~     muscle, called diaphragm, which separates the lung space from the space containing stomach,~     liver, kidneys and other internal organs in the abdomen. If the lead electrode is close to~     this nerve, it can cause a small part of it to contract giving you an uncomfortable~     hiccupping sensation.~      In many patients, phrenic nerve stimulation is not identified until after the implant~     procedure when movement and postural changes bring the LV lead into closer contact with the~     phrenic nerve.~      The investigation is performed to demonstrate the equality of performance of two different~     modalities of optimization of the implanted device and Quartet lead, Empirical (anatomical)~     optimization and Right Ventricle Left Ventricle (RVLV) conduction delay optimization.~   "
104785|NCT02195830|"~     There is debate regarding the use of non invasive (ultrasound assessed) parameters of fluid~     volume status in patients with sepsis.~      To establish the role of inferior vena cava ultrasound in guiding fluid resuscitation we~     first need to define the inferior vena cava collapsibility index in this population of~     patients.~      The research question is: In adult patients with sepsis, severe sepsis and septic shock what~     is the mean baseline inferior vena cava collapsibility index (IVCCI) prior to fluid~     resuscitation.~   "
104786|NCT02195817|"~     To determine the reduction in alcohol consumption in patients with alcohol dependence treated~     with 18 mg Selincro® as-needed use, in conjunction with continuous psychosocial support in~     primary care~   "
104787|NCT02195804|"~     The objective of this study is to establish the relative bioavailability (BA) of two~     different ranitidine hydrochloride 150 mg ODT formulation in comparison to the current, over~     the counter (OTC) ranitidine hydrochloride (Maximum Strength ZANTAC 150®) formulation~     following oral single dose administration in fasting healthy male volunteers~   "
104788|NCT02195791|"~     Pioglitzone, an oral anti-diabetic drug which can reduce insulin resistance and decrease~     inflammation. It has been proven to be an effective neuroprotective agent in animal model of~     ischemic stroke. In this study, the investigators will conduct a phase II clinical trial~     (double-blind, randomized placebo controlled study) to survey the neuroprotection effect of~     pioglitazone in stroke patients with hyperglycemia. A total of 152 acute ischemic stroke~     patients with hyperglycemic will receive insulin or sulfonyurea for blood sugar control, and~     will be randomly randomized into intervention (Pioglitazone 30mg once a day p.o,) and control~     group (placebo). The investigators expect to prove the neuroprotective efficacy of~     Pioglitazone in acute stroke with hyperglycemia and identify the biomarkers associated with~     good neurological outcome in patients with Pioglitazone treatment from the investigators~     clinical trial.~   "
104789|NCT02195778|"~     Health Literacy is the ability to understand health information and to use that information~     to make good decisions about health and medical care. Health informatin can overwhelm even~     people with advanced literacy skills. About one third of the adult population in the United~     States has limited health literacy.~   "
104790|NCT02195765|"~     This is a split-mouth, double-blind randomized controlled trial. Computerized linear~     radiographic measurements were used to detect infrabony defects treated with open flap~     debridement (OFD) or OFD associated with enamel matrix derivative (EMD), after 24 months. Ten~     patients presenting 2 or more defects were selected (43 defects). An individualized film~     holder was used to take standardized radiographs at baseline and after 24 months. Images were~     digitized and used to measure the distances from the cemento-enamel junction (CEJ) to the~     alveolar crest (AC), CEJ to the bottom of the defect (BD) and infrabony defect angle.~   "
104791|NCT02195752|"~     A two-year + 3 Mo. observational study to track compliance and outcomes in adult patients~     prescribed compounded pharmaceutical creams for the treatment of pain. The project is~     designed to accumulate tracking information from both patients and physicians over the course~     of therapy as a supplement to the ordinary care that the patients will normally receive. We~     seek to discover aspects of successful and unsuccessful treatment using topical pain creams.~     This information will be analyzed and reports prepared of observations and emergent findings.~     These reports will be sent during the study every 1 or 2 months to patients, physicians and~     pharmacists who are participating in the Study. A final compilation of findings and~     observations will be circulated to participating patients, physicians and pharmacists.~   "
104792|NCT02195739|"~     The aim of this study is to compare the cardiovascular disease event rate in smokers~     undertaking pharmacologically unaided smoking cessation attempts (the non-exposed group) with~     the event rate in smokers attempting smoking cessation assisted by pharmacological~     interventions - by nicotine replacement therapy (as any, or a combination, of: nasal spray,~     transdermal patches, inhaler or gum and tablets) or other pharmacological smoking cessation~     aids (e.g. bupropion [Zyban®] and varenicline [Champix®]) - in a representative UK primary~     care population.~   "
104793|NCT02195726|"~     The purpose of the present study is to determine if remote ischemic preconditioning reduces~     incidence of acute kidney injury in patients with reduced kidney function undergoing~     Percutaneous Coronary Intervention.~   "
104794|NCT02195713|"~     Urine output and urine drain line pressure were monitored while urine was drained into~     either:~        1. Accuryn Urine Output Monitor (Potrero Medical) OR~        2. Criticore Monitor (Bard Medical)~   "
104795|NCT02195700|"~     The purpose of this study is to determine whether an investigational drug, SD-809~     (deutetrabenazine), will reduce the severity of abnormal involuntary movements of tardive~     dyskinesia.~   "
104796|NCT02195687|"~     This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) compared~     with placebo in patients with moderate to severe crow's feet lines (lateral canthal lines).~   "
104797|NCT02195674|"~     The purpose of the EMBARK Follow-up Project (EFP) is to determine if there is a significant~     correlation between post-study massage-seeking and changes in pain reported by participants~     during the Exploring Massage Benefits for Osteoarthritis of the Knee (EMBARK) parent study~     (NCT00970008). The EFP hypothesizes that a positive correlation exists between pain relief~     during the parent study and post-study massage-seeking behavior.~   "
104798|NCT02195661|"~     This study aims to determine the safety and effectiveness of oral melatonin as natural~     inducer of sleep to acquire useful EEGs in South African children following its introduction~     as the main agent used in the Neurophysiology department at Red Cross Children's Hospital.~     This is an observational retrospective study.~   "
104799|NCT02195648|"~     The main objective of this study is to determine the effects caused in neck movement, neck~     pain, headache in patients with tension type headache and cervicogenic headache after~     application of sub-occipital muscle inhibition technique associated with interferential~     electrotherapy.~   "
104800|NCT02195635|"~     To evaluate the effect of octreotide acetate injections (200 µg 3 times daily [tid]) on the~     pharmacokinetics (PK) of telotristat ethyl and its metabolite LP-778902 relative to~     administration of single-dose telotristat etiprate in healthy male and female subjects~   "
104801|NCT02195622|"~     To compare efficiency, in terms of tissue morcellation and removal time, of two commercially~     available FDA-approved morcellators: the VersaCut and the Piranha in subjects undergoing~     HoLEP procedure for benign prostatic hyperplasia (BPH).~   "
104802|NCT02195609|"~     This study is aiming to evaluate changes in vasomotor symptoms in postmenopausal women~     treated for 4 months with Omega-3 vs Soy Isoflavones.~   "
104803|NCT02195596|"~     A program that combines high intensity aerobic exercise (<85% of Heart Rate Reserve) with~     resistance, progressive and moderate intensity intervals, carried out in primary care, is~     effective in terms of a smaller increase in respect to the baseline measurement in the total~     score of the ADAS cognitive section (Alzheimer Disease Assessment Scale-Cognitive section),in~     the control group that receives an intervention similar to low intensity (30-40% of Heart~     rate reserve).~      We Expect a difference of at least 3 points between the means of the increments between the~     intervention and control group.~   "
104804|NCT02195583|"~     This study will evaluate the effect of experimental sodium fluoride-silica dentifrice~     formulations, with and without zinc, on remineralization of enamel in situ. Following the~     remineralization phase, the acid resistance of the new mineral formed will be assessed.~     Fluoride uptake during the remineralization phase will also be measured.~   "
104805|NCT02195570|"~     The long-term goal of this research is to reduce tobacco-related disparities in maternal and~     infant health outcomes by improving smoking cessation and relapse prevention interventions~     for minority pregnant and postpartum women, who have been significantly underrepresented in~     smoking cessation research. This study will examine the feasibility and efficacy of a~     prize-based contingency management approach for increasing smoking cessation and preventing~     relapse among socioeconomically disadvantaged minority pregnant smokers. First, the~     intervention will be pretested with 10 pregnant low-income minority smokers and then refined~     based on acceptability survey and focus group data. Next, a pilot study will be conducted. 60~     highly disadvantaged minority women, recruited from the outpatient obstetric clinics at a~     large teaching hospital, who report daily smoking and who meet other eligibility criteria~     will be enrolled and randomized to one of two study conditions: 1) Standard Psychoeducational~     Intervention (6-week, individually-administered, pregnancy-specific Quit Smoking Now~     curriculum, as currently implemented in the clinic; QSN Only); 2) Standard Psychoeducational~     Intervention plus Contingency Management (provision of incentives contingent on~     biochemically-verified abstinence; QSN-CM). Abstinence monitoring via expired carbon monoxide~     and salivary cotinine levels will occur in both groups beginning on the first quit day and~     continuing through 3-months postpartum. Only participants in the QSN-CM group will be~     reinforced for biochemically-verified abstinence with chances to win prizes ranging in value~     from approximately $1 to $100 ('fishbowl' or 'prize bowl' method). Study outcomes will be~     assessed through follow-up research exams (delivery and 6-months postpartum) and hospital~     chart reviews. The primary hypothesis is that that women randomized to the QSN-CM condition~     will have higher rates of abstinence during pregnancy and postpartum compared to women~     receiving standard of care alone. Results should advance scientific knowledge regarding~     effective methods for promoting and maintaining smoking abstinence among pregnant~     disadvantaged women and provide preliminary feasibility and efficacy data needed to support a~     larger randomized controlled trial.~   "
104806|NCT02195557|"~     Retrospective collection of data, aimed at a better knowledge of the use of Synvisc® among~     the patients with knee osteoarthritis (OA) since at least three years.~   "
104807|NCT02195544|"~     Study of prescription methods in everyday medical practice, tolerance profile and effect of~     Synvisc® until six months of follow-up.~   "
104808|NCT02195531|"~     The study hypothesis: in groups receiving tailored education and feedback in a style that~     matches their psychological profile, will show a higher CPAP adherence rates than groups~     receiving mismatched tailored education / feedback, and groups that receive no tailored~     education and feedback (standard of care).~   "
104809|NCT02195518|"~     This is a phase IV, single-arm, open-label, multi-centre study to assess the efficacy of TDF~     in Chronic hepatitis B (CHB) subjects following failure of multiple Nucleos(t)ide analogues~     (NAs). The study will enrol 200 CHB subjects following failure of multiple NAs. Subjects will~     be assessed for eligibility at a screening visit, with eligible subjects returning for a~     baseline assessment after approximately 4 weeks (Screening phase). In the treatment phase all~     enrolled subjects will receive open label TDF at a dose of 300 milligrams (mg) orally once~     daily. All the eligible study subjects will undergo safety and efficacy assessments every 12~     weeks for a total of 14 visits. Tenofovir disoproxil fumarate, the oral pro-drug of tenofovir~     (TFV), is a nucleotide analogue that inhibits viral polymerases by direct binding and after~     incorporation into deoxyribonucleic acid (DNA), by termination of the DNA) chain. TDF is a~     highly potent treatment in treatment-naïve and lamivudine (LAM) resistant CHB patients. The~     purpose of our study is to evaluate the efficacy of TDF treatment in Chinese CHB patients~     following failure of multiple NAs. In addition, the study will also explore the relationship~     of baseline factors and early HBV DNA suppression to long-term virological response. The~     efficacy of TDF in multi-drug resistant patients will be analysed separately. The data~     generated by this study could then be used to optimize the clinical application of TDF and~     provide new evidence for management of the HBV infections following failure of multiple NAs.~     The result of this study will help Chinese physicians better manage the CHB patients~     following failure of multiple NAs.~   "
104810|NCT02195505|"~     The USAGE study aims at assessing on a long-term period (two years in average) the outcome in~     clinical or economical term of patients with knee osteoarthritis (OA) treated or not with~     Synvisc®, in the 1139.4 clinical trial.~   "
124896|NCT01932658|"~     The purpose of this study is to evaluate the safety and potential clinical benefit of~     lymphoablation followed by autologous HSCT rescue in therapy refractory Crohn's disease~   "
104812|NCT02195479|"~     The purpose of this study is to determine if the addition of daratumumab to velcade~     (bortezomib) melphalan-prednisone (VMP) will prolong progression-free survival (PFS) compared~     with VMP alone in participants with previously untreated multiple myeloma who are ineligible~     for high dose chemotherapy and autologous stem cell transplant (ASCT).~   "
104813|NCT02195466|"~     Study to determine the effects of single-dose and steady-state TPV/RTV 500/200 mg on the~     steady-state pharmacokinetics of fluconazole~   "
104814|NCT02195453|"~     The purpose of this study is to observe quality of life and treatment side effects in~     patients with advanced non small cell lung cancer (NSCLC) receive chemotherapy and~     Yangzhengxiaoji capsule.~   "
104815|NCT02195440|"~     The purpose of this study is to investigate the safety and tolerability of PRI-724 in~     patients with HCV-induced cirrhosis.~   "
104816|NCT02195427|"~     The purpose of this study is 1) to compare the effectiveness and safety of TEOSYAL® RHA~     Global Action versus Juvéderm® Ultra XC, and 2) to compare the effectiveness and safety of~     TEOSYAL® RHA Deep Lines versus Juvéderm® Ultra XC, in the treatment of moderate to severe~     nasolabial folds.~   "
104817|NCT02195414|"~     The NeoVas First-in-Man study is a prospective, two centers, single arm trial, which will~     enroll a total of 30 patients. The hypothesis of this study is to evaluate clinical~     feasibility, safety, and efficacy of NeoVas sirolimus-eluting bioresorbable coronary scaffold~     in the treatment of patients with de novo coronary lesion.~   "
104818|NCT02195401|"~     A child and their parent were asked to participate in a research project that sought to study~     whether sleeping in a very clean environment for 14 days improved the elimination of~     chemicals and metals from the child's body. The child had an approximately two hour~     evaluation to confirm his or her diagnosis of Autism or Pervasive Developmental Disorder. Not~     Otherwise Specified. When one of these diagnoses was confirmed the child was scheduled to~     spend 14 nights sleeping in a very clean environment in a specially created room at The~     Children's Institute.~      Several hours prior to the first night the child slept in the clean room the child's mother,~     father, or guardian filled out behavioral rating scales about the child with the assistance~     of the study's research coordinator. The child also had approximately two tablespoons of~     blood drawn from an arm and a few inch sample of hair was taken from the back of the child's~     head. The child and a parent or guardian arrived at The Children's Institute about one half~     hour prior to the child's normal time of settling for bed for 14 consecutive nights. The~     child and a parent or guardian slept in the clean room, wearing the provided very clean~     clothes and sleeping on special mattresses and sheets each night for 14 consecutive nights.~     The child and parent were observed by a nurse through a window during the time in the clean~     room. The child and parent participated in regular daytime activities during these 14 days of~     the study. On the morning after the last night the child and a parent or guardian slept in~     the clean room a parent or guardian filled out behavioral rating scales with the help of the~     research coordinator. Approximately two tablespoons of blood were drawn from an arm and a few~     inch sample of hair was obtained from the back of the child's head, at The Children's~     Institute or at home.~   "
104819|NCT02195388|"~     Myocardial infarction is related with endothelial function, arterial stiffness and autonomic~     nervous system dysfunction, but also with arterial hypertension. Hypertension by itself is~     also related with endothelial function, arterial stiffness and autonomic nervous system~     dysfunction.~      Primary aim of study is to investigate how complex cardiac rehabilitation influence~     endothelial function, arterial stiffness and autonomic nervous system activity according to~     presence or absence arterial hypertension.~      Secondary aim is to obtain correlation between methods for the assessment of particular~     disorders and intercorrelation between different disorders for example endothelial function~     and autonomic nervous system activity.~   "
104820|NCT02195375|"~     The purpose of this study is to investigate whether flutiform® is effective and safe in the~     treatment of chronic obstructive pulmonary disease (COPD).~   "
104821|NCT02195349|"~     This study is a phase I, randomised, double blind (sponsor unblinded), placebo-controlled,~     single ascending dose study GSK2831781 administered by IV. GSK2831781 is a humanized Antibody~     Dependent Cell Cytotoxicity (ADCC) enhanced monoclonal afucosylated antibody that is specific~     to the Lymphocyte Activation Gene-3 (LAG-3) protein. This is the first administration of~     GSK2831781 in humans and will evaluate in two parts the safety, tolerability,~     pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of single IV doses of~     GSK2831781 administered to healthy subjects previously vaccinated with Bacillus Calmette~     Guérin (BCG) (Part A delayed type hypersensitivity [DTH] cohorts) and patients with plaque~     psoriasis (Part B). The inclusion of DTH and psoriasis subjects to explore the mechanism in~     biopsies and clinical response endpoints in these populations, as well as investigate~     systemic biomarkers will provide useful information prior to conducting studies in other~     immune-inflammatory disease which will involve more invasive tissue biopsies. Measuring the~     pharmacology of GSK2831781 using the depletion of LAG-3+ T-cells in skin biopsies from~     Tuberculin Purified Protein Derivative (PPD) skin challenge and lesional skin biopsies from~     patients with psoriasis, will be helpful in understanding of the dose response relationship,~     which will be important for designing future studies in immuno-inflammatory diseases,~     including psoriasis. Approximately 67 subjects will be enrolled to complete dosing and~     critical assessments. The subject numbers will be split to approximately 40 healthy subjects~     (Part A) and 27 patients with psoriasis (Part B).~   "
104822|NCT02195336|"~     To date, there are no methods to reliably select which patients with non-squamous non-small~     cell lung cancer (NSCLC) that benefit most from treatment with bevacizumab. Data have shown~     that high levels of plasma VEGF are prognostic and correlates with a worse disease outcome in~     some tumour types, including advanced NSCLC.~      Recent data are suggestive of a predictive value of imaging techniques for early detection of~     antiangiogenic treatment efficacy in different cancers. To our knowledge there are no~     presented data available on correlation between changes in diffusion-weighted MR and response~     to bevacizumab treatment in lung cancer. The current study is designed as a pilot study to~     prospectively investigate changes in MR variables during treatment with bevacizumab and to~     detect signals of prognostic and/or predictive value of MR changes during treatment.~   "
104823|NCT02195323|"~     This study was designed to provide confirmation of safety of mesenchymal stem cells (MSCs)~     therapy in chronic kidney disease (CKD).~   "
104824|NCT02195310|"~     The purpose of this study is to compare the use of Prevena™ Incision Management System (IMS)~     versus standard wound care for the incision in subjects undergoing a sternal midline incision~     (sternotomy). The subjects targetted for the study are at high risk for surgical~     complications (like infections) around the environment of the incision.~      The study is conducted in The Netherlands, Germany and Austria.~   "
104863|NCT02194790|"~     Chronic kidney disease (CKD) is a major health problem in Thailand. Previous studies have~     demonstrated that integrated pre-dialysis care may slow the decline in renal function~     (Nephrol Dial Transplant.2009 Nov;24(11):3426-33). It is interesting to know whether early~     intervention especially in high risk groups like Diabetic may also improve outcome of these~     patients in primary health care setting resulting in delay of CKD progression.~   "
104825|NCT02195297|"~     Aim of this study was to evaluate by clinical, morphometric and non invasive instrumental~     evaluations the activity of an anticellulitis cosmetic product vs a reference product of~     the market (comparison within subjects), applied once a day, for an uninterrupted period of 4~     weeks, on 22 female healthy volunteers with low/moderate oedematous - fibrosclerotic~     lipodystrophy on the thighs.~      It was also aim of the study to evaluate cosmetic acceptability by the volunteers and~     products efficacy and tolerance both by investigator and volunteers.~   "
104826|NCT02195284|"~     This study is designed to assess the proportion of asthma subjects making critical and~     non-critical errors made in using ELLIPTA® inhaler compared with other commercially available~     inhaler devices such as the TURBUHALER®, MDI (metered-dose inhaler), and DISKUS/ACCUHALER®.~     This study will also assess the ease of use and preference between the ELLIPTA inhaler and~     the other commercially available inhaler devices. This is a randomized, open-label, placebo,~     crossover, multicentre study with a single visit. The study will comprise three sub-studies.~     Subjects will receive inactive treatment (placebo) via the ELLIPTA inhaler and one of the~     other inhaler devices depending on the sub-study they are allocated to. Only subjects who are~     naïve to the ELLIPTA inhaler and to one of the other inhalers that will be used in this study~     will be included. The study will be conducted in the Netherlands and the UK, and comprises~     one visit only. A sufficient number of subjects (at least 190) with asthma will be screened~     and 180 will be randomized to one of the three sub-studies. Eligible subjects will be~     allocated to one of the sub-studies in the following order depending on their experience of~     using the other inhaler (i.e., depending on which other inhaler they are naïve to).~      ELLIPTA, DISKUS, and ACCUHALER are registered trademarks of the GSK group of companies.~     TURBUHALER is a registered trademark of AstraZeneca.~   "
104827|NCT02195271|"~     Pain exerts a tremendous cost in healthy care, rehabilitation and lost productivity. It is is~     associated with a wide range of diseases and their social consequences is a public health~     problem.~      With the progress of neuroscience and studies on the plasticity of the central nervous~     system, it has been provided a better understanding of the neurobiological mechanisms of~     pain.~      The neurohormone Melatonin stands by having systemic and diverse mechanisms of action, both~     in physiological and pathological situations, with modulating effects on the process of~     nociceptive signaling and neurochemical mechanisms such as serotonergic, opioidergic and~     GABAergic, exerting anti-inflammatory action, analgesic activity among others.~      The advent of neuromodulation techniques such as transcranial direct current stimulation~     (tDCS), which promote changes in neuronal activity and signaling to be effective in~     conditions of chronic pain by attenuating changes in cortical excitability.~      There is clinical evidence of the analgesic effect of Melatonin and tDCS alone. Thus,~     considering the potential for each isolated intervention and the lack of knowledge of their~     combined effect, the authors propose the present study to investigate the effect of this~     combination on the heat-pain detection threshold and the neuroplasticity in the healthy~     subjects.~   "
104828|NCT02195258|"~     this study is designed to identify the genetic factors which can be implicated in the~     salbutamol responsiveness for asthmatic children in pediatric emergency department~   "
104829|NCT02195245|"~     CO2 removal is a mandatory part of modern anesthesia systems. Current chemical absorbers pose~     problems as the chemical granulate reacts not only with the CO2 but also the anesthetic~     drugs, producing organ toxic substances. The proposed CO2 absorber provides a solution to the~     problem of organ-toxin production in anesthetic circuits.~   "
104830|NCT02195232|"~     This research study is evaluating a drug called isoquercetin to prevent venous thrombosis~     (blood clots), in participants who have pancreas, non small cell lung cancer or colorectal~     cancer.~   "
104831|NCT02195219|"~     The aim of this study is to compare two therapeutical procedures for the grade III~     acromioclavicular dislocations, either open reduction and internal fixation with a~     coracoclavicular device (MINAR-STORZ ) or non operative treatment.~      For these purpose we have designed an interventional, prospective, parallel assignment,~     opened and randomized study.~   "
104832|NCT02195206|"~     In this pilot study, MRI of the lungs of healthy adult volunteers will be performed at 3Tesla~     to assess image quality using a prototype chest coil and pulse sequence following inhalation~     of hyperpolarized 129Xe (xenon) gas. This study will take place at the Hospital for Sick~     Children, Toronto, Canada. Thirty two subjects aged 18 to 75 will participate in this study.~     Xenon MRI is a non-invasive imaging technique that does not involve X-rays or ionizing~     radiation. Rather, this imaging method utilizes the same hardware and software principles~     that are used for conventional proton MRI of patients in a hospital. The investigators are~     testing the abilities of xenon MRI to see if it will produce lung images of equal or better~     quality to that of proton MRI.~      The investigators hypothesize that they will get good quality images of the lungs for~     analysis using our method.~   "
104833|NCT02195193|"~     The overall goal of this study is to develop, pilot test, implement, and evaluate a~     nurse-coordinated depression care model integrated into the care of Acute Coronary Syndromes~     (ACS) patients with rigorous assessment of feasibility, effectiveness, acceptability and cost~     in rural China. This study is a large multi-center, randomized clinical trial among 4,000 ACS~     patients from 20 rural county hospitals selected from a well-established research network~     across China.~   "
104834|NCT02195180|"~     A new approach that aims to destroy pancreatic tumor cells through modification of the tumor~     environment.~      Asparagine synthetase (ASNS) is an enzyme wich synthetise asparagine. Asparagine is an~     essential nutriment for pancreatic cancer cells which have no or low level of ASNS.~      by L-asparaginase encapsulated in erythrocytes deplete (supress) Plasma asparagine.~      in selected patients having no or low ASNS, may provide a new therapeutic approach.~   "
104835|NCT02195167|"~     Pediatric PK study of SEP-225289 (Dasotraline)~   "
104836|NCT02195154|"~     Forty patients with clinically diagnosed VP and 20 healthy subjects will be enrolled in the~     study. Each evaluable subject involved in this study must fulfill all the inclusion and~     exclusion criteria and each subject will have 3 visits in the study, as one screening visit,~     one imaging visit, and one safety evaluation visit.~   "
104837|NCT02195141|"~     Pathological complete response, (pCR) correlates with a favorable overall prognosis in~     locally advanced rectal cancer patients underwent preoperative chemoradiation, so obtaining a~     pCR might be beneficial. The aim of the study is to investigate safety and efficacy of~     preoperative SIB-IMRT(56Gy) combine with capecitabine. primary endpoint is pathological~     complete remission rate.~   "
104841|NCT02195076|"~     The investigators have developed an early detection solution for lung and breast cancer. A~     system which can distinguish between different medical odors based on biosensors. Our product~     is user-friendly noninvasive, nonradioactive and nontoxic to the patients. The technology~     enables a high level of sensitivity and provides users with a quick lab response and a simple~     yes or no answer.~      The aim of this study is to contribute and detect the patient at the earliest possible stage,~     in a noninvasive, nonradioactive and nontoxic way. Exhaled breath and urine samples are a~     promising approach towards future possible lung and breast cancer screening method.~   "
104842|NCT02195063|"~     This is a survey study that will be given to patients who have been prescribed a topical~     compound for pain management, wound care or scar care or to patients who have been requested~     to do a urinary drug test (UDT) by their provider.~      The initial survey for pain management, wound care, scar care or UDT will be given to the~     patient by their providers during their office visit.~   "
104843|NCT02195050|"~     1. At target LDL-C levels, apoB100 concentrations will be higher than recommended levels in~          the following populations:~             1. Tertiary centre lipid clinic patients with raised TG treated with statins.~             2. Patients with type 2 diabetes treated with statins.~             3. Patients with Chronic Kidney disease (CKD) stages 4 and 5 treated with statins.~        2. Despite achieving LDL-C and non-HDL-C targets, a significant number of statin-treated~          patients have residual cardiovascular risk related to raised hsCRP. The relationship~          between hsCRP and Lp-PLA2 (markers of inflammation) and LDL particle number measured by~          apoB100 is stronger than that of measured and calculated LDL and non-HDL. In statin~          treated patients there will be higher levels of hs-CRP and Lp-PLA2 in patients achieving~          LDL targets but not apo B targets.~        3. We hypothesise that non-diabetic patients with severe hypertriglyceridaemia (fasting~          serum triglyceride >5.5 mmol/l) have evidence of greater nerve damage compared with~          matched controls.~        4. LAL deficiency is underdiagnosed in patients with severe hypertriglyceridaemia, low~          HDL-C, hyperlipidaemias, non alcoholic fatty liver disease and idiopathic high liver~          enzymes.~   "
104844|NCT02195037|"~     Recently, the American College of Obstetricians and Gynecologists (ACOG) recommended a delay~     of 30-60 seconds in umbilical cord clamping for all newborn infants. This delay allows the~     newborn to receive his/her own blood from the placenta (placental transfusion) which helps~     their transition in the first hours of life. The purpose of the study is to learn about the~     amount of blood flow to and from the baby's heart during normal newborn transition~   "
104845|NCT02195024|"~     Aim of this trial is to investigate feasibility of cardiac magnetic resonance imaging (cMRI)~     in patients with long term implanted coradial leads upgraded to an MRI conditional pacemaker~     system, to assess MR-image quality and to prove the safety of MRI in this specific population~     in the short term as well as during long term follow-up.~   "
104846|NCT02195011|"~     The purpose of this study is to determine the safety of regorafenib, an antiangiogenic drug,~     when combined with radioembolization using SIR-Spheres® microspheres in the treatment of~     colorectal cancer (CRC) that has spread to the liver.~   "
104847|NCT02194998|"~     HIV and hepatitis C virus (HCV) infection are diseases that share the same risk factors and~     routes of transmission. For this reason, many people infected with HIV are also infected with~     HCV. Interferon (IFN) is a drug used to treat HCV; however, in people coinfected with HIV and~     HCV, IFN treatment often does not work well and can cause unwanted side effects. The purpose~     of this study is to evaluate the safety, tolerability, and effectiveness of IFN-free HCV~     treatment in HIV/HCV coinfected adults who are taking antiretroviral (ARV) therapy.~   "
104848|NCT02194985|"~     This is an open-label extension study intended to provide continued treatment with migalastat~     HCl for subjects with Fabry disease who completed treatment of a previous migalastat HCl~     monotherapy study.~      The study will assess the long-term safety and effectiveness of migalastat HCl in subjects~     with Fabry disease who completed migalastat HCl treatment in a previous study.~   "
104849|NCT02194972|"~     The purpose of this study is to investigate the effect of pectin, a kind of soluble dietary~     fiber, on colonic transit time, clinical symptoms and the gut microbiota in adults with~     slow-transit constipation.~   "
104850|NCT02194959|"~     Cancer health disparities related to race and ethnicity are among the most serious problems~     facing the US health care system. A recent institute of medicine report stated that such~     disparities are seen at every level of health care, from prevention to treatment and~     follow-up. This problem is acutely evident in the figures for colorectal cancer (CRC) among~     African Americans. According to the American cancer society, African Americans have the~     highest CRC incidence and mortality of any ethnic/racial group. Indeed, CRC incidence and~     mortality are 15% and 43% higher among African Americans than whites, respectively. These~     disparities could be effectively reduced through greater African American participation in~     CRC screening and early detection. More importantly, due to the preponderance of CRC in~     African Americans beyond the reach of the flexible sigmoidoscopy (1), increased adherence to~     colonoscopy among African Americans will save lives. Although there is clear evidence that~     providing patients with someone to help them manage/navigate the health care system (i.e.,~     patient navigation (PN)) is effective in helping them to complete cancer screening, very few~     hospitals provide PN for colonoscopy. The vast majority of hospitals in NYC are unable to~     provide PN for patients for whom colonoscopy is recommended, in large part because of the~     costs associated with professional-led PN. This project seeks to address this serious public~     health problem by investigating the success of training African Americans who have undergone~     colonoscopy to serve as volunteer peer patient navigators to encourage others from their~     community to complete CRC screening via colonoscopy.~   "
104864|NCT02194777|"~     The objective of the present study is to obtain information about the safety, tolerability~     and pharmacokinetics of BIBN 4096 BS after single inhalative administration of increasing~     doses in healthy male and female volunteers~   "
104865|NCT02194764|"~     The purpose of this study is to develop a cost-effective breath-based medication adherence~     monitoring system that can monitor whether recovering opiate addicts actually take a specific~     treatment medication called naltrexone.~   "
104889|NCT02194452|"~     This pilot clinical trial studies gallium Ga 68-edotreotide (68Ga-DOTATOC) positron emission~     tomography (PET)/computed tomography (CT) in finding brain tumors in younger patients.~     Diagnostic procedures, such as gallium Ga 68-edotreotide PET/CT imaging, may help find and~     diagnose brain tumors.~   "
104851|NCT02194946|"~     Stage 5 chronic kidney disease (CKD), also end stage renal disease(ESRD), usually presents~     overt clinical symptoms and is a critical stage when patients are encountered with dialysis.~     The optimal time to initiating dialysis in patients with stage 5 CKD is addressed as the most~     important dialysis-related question. As indicated by the recently published European Renal~     Best Practice (ERBP) guideline, early initiation seemed to produce no benefit but greater~     expenditure and sometimes more harm.Renal replacement therapies (RRT) including dialysis are~     the most common procedures for patients with end-stage renal disease (ESRD), but conservative~     management should be an option in patients who still experience the stable period without~     clinical indications of dialysis.Chinese Medicine (CM) is recognized as an alternative~     therapy on alleviating uremic symptoms, deferring dialysis initiation, and improving quality~     of life. Although the effects of CM on kidney disease have been demonstrated in animal~     experiments, evidence from large clinical trial is insufficient. So we raise the hypothesis~     that CM therapies including Chinese herbal formula, Chinese patent medicine via oral pattern~     and/or Colonic administration, will defer the initiation of dialysis in adults with stage 5~     CKD.~   "
104852|NCT02194933|"~     The purpose of this study is to evaluate the effect of brexpiprazole, via functional magnetic~     resonance imaging (fMRI), on the right ventrolateral prefrontal cortex (VLPFC) activated by~     impulsive behavior.~   "
104853|NCT02194920|"~     The purpose of this study is to evaluate safety and effectiveness of normal parathyroid~     tissue reimplantation in forearm subcutaneous tissue in case of accidental removal of~     parathyroid gland during thyroid surgery.~   "
104854|NCT02194907|"~     This study will determine whether brain activity can be modified and improves performance on~     a task by showing participants live 'video feed' of their brains on advanced imaging~     technology. The study is particularly interested in brain regions that have been shown to be~     relevant for emotions, specifically the anterior insula and the medial prefrontal cortex.~     Advanced technology will map the brain using magnetic pulses with a real-time functional~     Magnetic Resonance Imaging (rt-fMRI) machine.~   "
104855|NCT02194894|"~     In this first pilot study, we will examine the effects of acetaminophen dosing in adult~     patients with NAFLD in comparison to the effects in a healthy control group. Both groups will~     receive 3 grams (g) of acetaminophen, the maximum recommended daily dose, daily for 14 days.~     We hypothesize that NAFLD patients are more prone to APAP toxicity than normal~     controls.Treatment will be stopped after two weeks or in the following conditions:~      Treatment with APAP will be stopped in healthy volunteers if ALT and/or AST reached three~     times the ULN. In patients with NAFLD, treatment will be stopped if: ALT or AST reach ≥ three~     times the upper limit of entry value or ≥ 5 times the ULN; or if there is ALT or AST >3 times~     ULN and TBili >2xULN or INR >1.5; or if there is ALT or AST >3 times ULN with the appearance~     of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, and/or~     eosinophilia (>5%). We follow a conservative approach derived from the FDA guidelines for~     stopping medications expected to cause drug induced liver injury (DILI). Indeed, the FDA~     allows continuation of the medication until ALT or AST are >8x ULN in the absence of elevated~     Tbili or INR. Patients who have hepatotoxicity will have close monitoring of their liver~     enzymes until they normalize. Taking acetaminophen up to 3g daily has been shown to be safe~     and acceptable. We have followed very strict criteria for monitoring and stopping rules~     however in the usually cases of toxicity the patient will be admitted for monitoring.~   "
104856|NCT02194881|"~     The purpose of this study is to determine whether the treatment with Ivacaftor remains~     effective and safe in the patients with cystic fibrosis (and at least one G551D CFTR~     mutation) in the real life setting, after the drug has been approved by the Health~     authorities.~   "
104857|NCT02194868|"~     The purpose of this study is to confirm that invariant NKT lymphocytes (iNKT) reconstitution~     in recipient and in the graft content can predict the outcome of human allogeneic HSCT and to~     set up an algorithm for clinical practice that would allow the prediction of acute GVHD risk~     according to the quantity and functionality~   "
104858|NCT02194855|"~     The investigators investigated whether laparoscopic versus open surgical approaches affected~     the pharmacokinetic and pharmacodynamic of a single bolus dose of rocuronium or~     cisatracurium.~   "
104859|NCT02194842|"~     The objective of this randomized phase III open label trial is to assess if upfront~     combination of enzalutamide and Ra223 improves radiological progression-free survival~     compared to enzalutamide single agent in asymptomatic or mildly symptomatic castration~     resistant prostate cancer patients metastatic to bone.~   "
104860|NCT02194829|"~     This partially randomized phase I/II trial studies the side effects and best dose of WEE1~     inhibitor MK-1775 when given together with paclitaxel albumin-stabilized nanoparticle~     formulation and gemcitabine hydrochloride and how well they work in treating patients with~     previously untreated pancreatic cancer that has spread to another place in the body or cannot~     be removed by surgery. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized~     nanoparticle formulation and gemcitabine hydrochloride, work in different ways to stop the~     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. WEE1 inhibitor MK-1775 may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. It is not yet known whether paclitaxel~     albumin-stabilized nanoparticle formulation and gemcitabine hydrochloride are more effective~     with or without WEE1 inhibitor MK-1775 in treating patients with pancreatic cancer.~   "
104861|NCT02194816|"~     We are trying to identify factors associated with improved quality of life and fewer PD~     symptoms. We are attempting to identify practices, beliefs, and therapies used by individuals~     who report excellent quality of life, few PD symptoms, and reduced rates of progression.~     After agreeing to participate, we will ask participants to fill our questionnaires about~     their experience with PD, their health in general, along with their food intake every six~     months for five years.~   "
104862|NCT02194803|"~     A multicentre, open-label, non-interventional study to observe treatment patterns in patients~     with wet age-related macular degeneration (wAMD), with visual impairment due to diabetic~     macular edema (DME), due to macular edema following retinal vein occlusion (RVO) or due to~     chorioidal neovascularization following pathologic myopia (mCNV) with repeated intravitreal~     injections of Lucentis® (Ranibizumab) including optional OCT monitoring over a 24 months~     observational period under real life conditions.~   "
104866|NCT02194751|"~     This Phase II trial studies the overall tumor response of vaccine therapy in patientswith~     previously untreated Stage III or IV, asymptomatic, non-bulky follicular lymphoma. The~     vaccine contains an extract of the patient's own cancer cells and the immunostimulant~     protein, interleukin-2 (IL-2). It is hoped that when injected under the skin, the vaccine~     will enable the patient's immune system to recognize and destroy the cancer cells. The trial~     will also assess the safety of the vaccine, the time from vaccine treatment until the patient~     requires another type of anti-lymphoma treatment, progression-free survival, and the~     anti-tumor immune response.~   "
104867|NCT02194738|"~     This ALCHEMIST trial studies genetic testing in screening patients with stage IB-IIIA~     non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in~     a patient's tumor cells may help doctors select the best treatment for patients that have~     certain genetic changes.~   "
104868|NCT02194725|"~     Background:~      - Children with Duchenne/Becker Muscular Dystrophy (DBMD) slowly lose muscle function. They~     usually die at a young age. Some mothers adapt to the demands of caring for a child with this~     disease better than others. Studies show that a person s hope may positively affect how they~     cope and adapt. Researchers want to find out more about this. They want to develop ways to~     improve caregivers overall wellness.~      Objective:~      - To study the relationships between uncertainty, hope, and coping ability in mothers of~     children with DBMD.~      Eligibility:~      - Women in the United States 18 years and older. They must be biological mothers of a living~     child with DBMD and be able to answer a survey in English.~      Design:~        -  This study is part of a larger study that examines the well-being of mothers with sons~          who have DBMD.~        -  Participants will take a questionnaire. The questionnaire can be done on paper or on a~          computer. It will take 30 45 minutes to complete.~        -  The questionnaire will include basic demographic questions about the participant and the~          child. There will also be questions about how the participant copes with the stress and~          uncertainty of DBMD.~        -  For most of the questions, participants will rate their feelings on a scale. There will~          also be four open-ended questions.~   "
104869|NCT02194712|"~     Schistosomiasis is increasingly encountered among travellers returning from the tropics and~     is known for its focal endemicity, associated with the presence of the snail intermediate~     host in fresh water. Because schistosomiasis in travellers is often atypical or asymptomatic~     due to the low intensity of infection, many infections likely go undiagnosed and will develop~     into chronic schistosomiasis. Conventional treatment of schistosomiasis in travellers with~     praziquantel 40mg/kg daily dose is known for its modest success rate. Diagnosis of~     schistosomiasis relies on egg detection, which has a poor sensitivity in low burden~     infections, or serology, which is inadequate to monitor cure. The department of parasitology~     of the Leiden University Medical Center has developed a novel diagnostic test based on the~     up-converting phosphor technology (UCP) to detect circulating anodic antigen (CAA). This test~     can be performed on serum and urine to detect low intensity schistosomiasis infections and~     confirm cure after praziquantel treatment. This study will assess the performance of UCP-CAA~     in travellers with high-risk water contact.~   "
104870|NCT02194699|"~     A 52-Week, Multicentre, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Phase 3~     Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents with~     Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist~   "
104871|NCT02194686|"~     1. The number and function of circulating endothelial progenitor cells (EPCs) are inversely~          associated with coronary risk factors and atherosclerotic diseases.~        2. This double-blind, randomized, placebo-controlled trial to evaluate the effects of~          cilostazol on human early EPCs and endothelial function as well as the potential~          mechanisms of action in patients with high risk for cardiovascular disease.~   "
104872|NCT02194673|"~     Interesterified (IE) fat blends will respond differently in terms of postprandial lipemia and~     insulinemic responses compare to a trans free palm margarine (TFPM).~   "
104873|NCT02194660|"~     Aims: to Establish the FLS services at the National Taiwan University Hospital (NTUH) and its~     Beihu Branch (BB).~      Method: From Jan., 2014, two related fracture liaison services (FLSs) following the 13~     'Capture the Fracture Best Practice Standards' were implemented at the National Taiwan~     University Hospital (NTUH) health care system. The main hospital (MH) program enrolled~     patient with 1) new hip fracture 2) newly identified radiographic vertebral fractures or 3)~     clinical vertebral fractures from both inpatients and outpatients. The Beihu branch (BB)~     program enrolled only the later two types of patients from outpatients. During the whole~     study period, two programs planed to enroll 600 fracture patients. Each patient would be~     assessed at baseline, and every 4 month for at least one year.~   "
104874|NCT02194647|"~     BACKGROUND:~      One-year adherence to oral anti-osteoporosis medication (AOMs) was only about 30%. In recent~     years, efforts have been made to change the delivery of these medications from oral form to~     injection form every, 3, 6 or 12 months to increase adherence. However, both patients and~     providers are sometimes confused about the multiple choices. Also, patients may receive extra~     medications if providers did not keep tract of their previous AOM uses or patients may~     changes providers. There were urgent needs to provide AOM monitoring and management services~     to improve cares.~      OBJECTIVES:~      To establish a anti-osteoporosis medication management service at National Taiwan University~     Hospital and its BeiHu Branch.~      METHODS:~      Participating physicians will select those eligible for services and refer to study~     coordinators. Study coordinators will conduct baseline assessments on osteoporosis/fracture~     risks, record medical conditions, AOMs, provide educations on osteoporosis, fracture,~     sarcopenia, fall, medications, nutrition, and exercise. They also arrange return clinic~     visit, telephone reminder and follow up for patients, and communicate with providers on~     regular bases. the investigators plan to enroll 500 patients with 18-month follow up for~     each.~   "
104875|NCT02194634|"~     This study is designed to assess safety and efficacy of intravitreal injection of Conbercept~     on visual acuity and anatomic outcomes in patients with diabetic macular edema (DME) .~   "
104888|NCT02194465|"~     The main purpose of this study is to evaluate the safety and effectiveness of the study drug~     known as LY2623091 in participants with high blood pressure.~   "
105639|NCT02184650|"~     The main goal of this study is to determine, in preterm infants born with a GA < 32 weeks,~     the association between:~        -  the quantity of mother's milk and duration and breastfeeding~        -  the intake of polyunsaturated fatty acids and iron during hospitalizations~   "
104876|NCT02194621|"~     The primary objective was to evaluate the antibacterial effects of two toothpastes containing~     0.3% triclosan, 2% copolymer and 0.234% sodium fluoride in a silica base as compared to a~     control regular fluoride toothpaste on anaerobic and malodor bacteria 12 hours after 13 days~     of product use. A secondary objective was to demonstrate that a toothpaste containing 0.3%~     triclosan, 2% copolymer, 0.234% sodium fluoride and a flavor with odor-masking ingredients in~     silica base (Colgate Total Toothpaste-Flavor Option 1) provides a level of antibacterial~     efficacy that is equivalent to a toothpaste containing 0.3% triclosan, 2% copolymer, 0.234%~     sodium fluoride and a regular flavor in silica base (Colgate Total Toothpaste-Flavor Option~     2) after 13 days of product use.~   "
104877|NCT02194608|"~     The primary goal is to evaluate whether a home telehealth system that enables the participant~     to monitor their body weight, blood glucose values and blood pressure values, associated with~     remote educational support and feedback to the general practitioner, can improve metabolic~     control and overall cardiovascular risk in individuals with type 2 diabetes mellitus (T2DM),~     as compared to usual practice.~   "
104878|NCT02194595|"~     Type 2 diabetes mellitus is a chronic metabolic disorder characterized by progressive~     deterioration in the function of the pancreatic beta-cells, which are the cells that produce~     and secrete insulin (the hormone primarily responsible for the handling of glucose in the~     body). The investigators propose a randomized controlled trial to determine whether combining~     basal insulin with a new medication called exenatide is a therapeutic strategy that can~     preserve beta-cell function early in the course of type 2 diabetes.~   "
104879|NCT02194582|"~     The investigators are trying to learn more about the cause of kidney diseases such as Focal~     Segmental Glomerulosclerosis (FSGS) and Nephrotic syndrome by studying genetics. The~     investigators are interested in discovering which genes play a role in causing a~     predisposition to FSGS/NS. The investigators also want to learn why FSGS/NS can run in~     families. Participation in our study involves a saliva sample and a urine sample that you can~     give from home. There is no cost to participate. All information is kept private and~     confidential. The investigators also like to include healthy volunteers (parents, spouses) if~     interested/available but of course this is completely optional.~   "
104880|NCT02194569|"~     Rationale:~      A higher citrate dose during continuous venovenous hemofiltration provides better~     anticoagulation but possibly a higher risk of citrate accumulation in case of metabolic~     limitations. A higher citrate dose also increases magnesium loss in ultrafiltrate, while a~     negative magnesium balance is unwanted.~      Objective:~      Aim of this study is to determine the magnesium balance of citrate-based continuous~     veno-venous hemofiltration (CVVH) and to determine whether and to which extent the magnesium~     balance depends on citrate dose.~      Study design and methods:~      A prospective randomized study conducted in critically ill patients with acute kidney injury~     (AKI), treated with CVVH, with either low dose citrate (2.5 mmol/L blood flow in the filter)~     or high dose citrate (4.5 mmol/L blood flow in the filter) as anti-coagulant, targeting a~     postfilter ionized Calcium (iCa) of resp. 1.3-1.6 mg/dL (0.325-0.4 mmol/L) and 0.8-1.1 mg/dL~     (0.2-0.275 mmol/L). Post-filter blood as well as effluent aliquots and bloodconcentrations in~     the patient are tested for the following variables:~      (0 , 2 , 4, 6, 12 and 24 hrs): Total Magnesium (tMg) and total Calcium (tCa), ionized Ca~     (iCa)(bloodgas analyzer). In addition, hematocrit, albumin, total protein, ureum and~     creatinine and parathormone (PTH) are determined in arterial blood at 0 and 24 hrs or at the~     time of protocol exit and citrate concentrations in postfilter and arterial blood at 1 and 24~     hrs or at protocol exit.~      Sample sites: arterial line, postfilter port (after postdilution and calcium compensation),~     effluent sample. All flow rates to be noted.~      Study population:~      Twenty patients admitted to intensive care, requiring continuous renal replacement therapy~     (CRRT) for AKI.~      Intervention:~      Anti-coagulation with either low dose citraat (2.5 mmol/L blood flow) or high dose citraat~     (4.5 mmol/L blood flow) targeting postfilter iCa of resp. 1.3-1.6 and 0.8-1.1 mg/dL. Both~     regimens are within standard protocolled CVVH treatment in the intensive care department.~   "
104881|NCT02194556|"~     This randomised, controlled, open-label, prospective trial is designed to assess the efficacy~     and safety of icotinib maintenance therapy after sequential Icotinib plus chemotherapy versus~     Icotinib maintenance therapy after chemotherapy in stage IIIB/IV non-small cell lung cancer~     patients with EGFR mutation.~   "
104882|NCT02194543|"~     To validate a high-definition (HD) three-dimensional (3D) visualization system in cataract~     surgery~   "
104883|NCT02194530|"~     This pilot study is will examine the pathways involved in allergic response, primarily in~     food allergy; specifically peanut allergy. We will also study non-allergic donors as well as~     patients with atopic disorders, primarily as control subjects. We believe that this study~     will lead to discovery of significant pathways involved in the allergic pathway that can be~     explored in more detail during follow-up studies in order to address mechanistic questions~     that cannot be answered in a pilot trial. We believe that such a pilot study represents the~     ideal approach to identify effective therapeutic interventions and to simultaneously better~     understand the underlying mechanistic properties involved in the allergy cascade. We think~     that this study forms the basis for a novel avenue of research into the pathogenesis of~     allergic pathways, a disease that is still associated with significant morbidity and~     mortality.~   "
104884|NCT02194517|"~     ELKa system is an advanced toolset which helps performing calculation of carbohydrate (CHO)~     and fat/protein (FP) exchanges. It consists of ELKa software including database of various~     meals and nutrients and ELKaPlus digital kitchen scale transmitting weight of products in a~     real-time to a computer via universal serial bus (USB) port. After choosing the name of~     particular product from the list, the program gives precise information about the amount of~     CHO and FP exchanges in serving.~      The aim of the study is to investigate the benefit of using ELKa toolset in comparison with~     standard method of CHO and FP counting on metabolic control in type 1 diabetic children.~   "
104885|NCT02194504|"~     In the Belly Fat study, the effects of two different caloric-restricted diets on metabolic~     health will be examined in male and female subjects with increased abdominal adiposity (BMI~     >27 kg/m2). Metabolic health is defined as health of the primary metabolic organs the liver,~     gut and the adipose tissue, examined in a static state as well as after the application of a~     challenge test.~      The diets are equally caloric-restricted, but differ in nutrient composition. It is~     hypothesized that one of the two diets causes a larger improvement in organ health and~     reduction in liver fat.~   "
104886|NCT02194491|"~     The purpose of this study is to evaluate a novel PET tracer ([11C]AS2471907), and to use~     [11C]AS2471907 to assess the level and time-course of enzyme occupancy in the human brain~     prior to and following single oral dose administration of ASP3662.~   "
104887|NCT02194478|"~     This is a pre-post intervention pilot study to evaluate the impact of a 30-minute, 8-week~     mind-body/meditation intervention on self-reported quality of life in individuals employed by~     Allina Health. Outcomes will include validated questionnaires for depressive symptomology,~     perceived stress, anxiety, healthy lifestyle, quality of life as well as biological outcomes~     of salivary cortisol for a sub-sample of employees.~   "
104890|NCT02194439|"~     This study is designed to collect longitudinal biological samples from patients after~     hematopoietic cell transplantation (HCT) cared for at multiple bone marrow transplant centers~     to validate biomarkers of both acute and chronic GVHD as well as for use in future~     unspecified research. The centers include Dana-Farber Cancer Institute and Boston's~     Children's Hospital, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Fred Hutchinson~     Cancer Research Center, Texas Children's Hospital, Children's National Medical Center, and~     Indiana University Simon Cancer Center.~   "
104891|NCT02194426|"~     This research study is looking at a new DARPin based medication, called MP0250. There is~     evidence from preclinical studies that MP0250 may be effective in the treatment of cancer.~     This is the first study of MP0250 in humans and its main purpose is to test its safety and~     tolerability in patients with cancer. This study will also examine how the drug is changed by~     and removed from the body and look for indicators that the drug may be effective against~     cancer. This study will test several different dose levels of the study drug to determine the~     safety and tolerability profile of the drug.~   "
104892|NCT02194413|"~     This randomized pilot clinical trial studies healing touch or usual care in improving quality~     of life in patients undergoing stem cell transplant. Healing touch may improve the quality of~     life of patients undergoing stem cell transplant.~   "
104893|NCT02194400|"~     A one month multi-dose study will evaluate the safety and tolerability of 3 intravenous~     infusions of RSLV-132 in subjects with inactive to mild SLE.~   "
104894|NCT02194387|"~     Objectives:~      Pilot 1 Primary aim: To explore the feasibility of using the Multi-phase Optimization~     Strategy (MOST) approach to optimize energy balance (EB) interventions in a sample of MD~     Anderson employees. To address this aim, investigators will record and assess study and~     intervention implementation, participant adherence to intervention component requirements,~     and satisfaction with intervention approach and specific intervention components. Feasibility~     of individual components and the overall intervention will be determined as described in the~     protocol.~      Pilot 2 Primary aim: To explore the feasibility of using the MOST approach to optimize energy~     balance interventions in a sample of BRCA (BReast CAncer) positive and Lynch Syndrome~     positive individuals and their family members. To address this aim, investigators will record~     and assess study and intervention implementation, participant adherence to intervention~     component requirements, and satisfaction with intervention approach and specific intervention~     components. Feasibility of individual components and the overall intervention will be~     determined as described in the protocol.~      Pilot 3 Primary aim: To explore the feasibility of using the MOST approach to optimize energy~     balance interventions in a sample of CLL (Chronic Lymphocytic Leukemia) patients. To address~     this aim, investigators will record and assess study and intervention implementation,~     participant adherence to intervention component requirements, and satisfaction with~     intervention approach and specific intervention components. Feasibility of individual~     components and the overall intervention will be determined as described in the protocol.~   "
104895|NCT02194374|"~     Gene transfer is a process in which the DNA (genetic material) of certain cells is changed.~     In this study, gene transfer will be performed on a type of white blood cell (called T cells)~     to recognize leukemia cells in the same person the T cells were collected from.~      The goal of this clinical research study is to learn if it is safe to give these~     genetically-changed T cells back to patients with CLL/SLL. Researchers also want to learn if~     these cells can help to attack CLL/SLL cells.~   "
104896|NCT02194361|"~     Study to determine the Efficacy of Standardised Bilberry Extract in improving the night~     vision and to evaluate its tolerability and safety.~   "
104897|NCT02194348|"~     The objective of the present study was to obtain information about safety, tolerability and~     pharmacokinetics of BIBN 4096 BS after single subcutaneous administration of increasing doses~     in healthy male and female volunteers~   "
104898|NCT02194335|"~     The objective of the present study was to obtain information about safety, tolerability and~     pharmacokinetics of BIBN 4096 BS after oral administration of increasing doses in healthy~     male and female volunteers. With respect to pharmacokinetics, it was of particular importance~     to investigate whether therapeutic plasma levels (for treatment of migraine) could have been~     achieved by oral administration of a BIBN 4096 BS formulation.~   "
104899|NCT02194322|"~     The objective of the present study is to obtain information about the safety, tolerability~     and pharmacokinetics of BIBN 4096 BS after single intranasal administration of increasing~     doses in healthy male and female volunteers~   "
104900|NCT02194309|"~     To investigate safety, tolerability, and pharmacokinetics of telmisartan and amlodipine~     following single administration of 40 mg telmisartan/5 mg amlodipine and 80 mg telmisartan/5~     mg amlodipine, and subsequently, following multiple administration of 40 mg telmisartan/5 mg~     amlodipine and 80 mg telmisartan/5 mg amlodipine once daily for 10 days~   "
104901|NCT02194296|"~     Study to investigate the relative bioavailability of a 20 mg ambroxol hydrochloride lozenge~     compared to 30 mg ambroxol hydrochloride syrup (Mucosolvan®) after dose normalisation~   "
104902|NCT02194283|"~     The main objectives of the present study are to determine pharmacokinetics of ambroxol in~     healthy male volunteers following repeated administration of lozenges of 20 mg ambroxol for~     four days~   "
104903|NCT02194270|"~     Study to investigate the relative bioavailability of ambroxol hydrochloride soft pastilles 15~     mg vs. ambroxol hydrochloride (HCL) 15 mg of syrup (15mg/5mL, Reference I) and ambroxol~     hydrochloride 15 mg of syrup (30mg/5mL, Reference II) in a fasted state~   "
104904|NCT02194257|"~     Study to determine the basic pharmacokinetics of ambroxol and [14C]-radioactivity including~     mass balance, excretion pathways and complete metabolism in healthy male volunteers following~     administration of a lozenge of 20 mg ambroxol together with an oral solution of 0.4 mg~     [14C]-ambroxol labelled in two different positions~   "
104905|NCT02194244|"~     This study will compare the pharmacokinetic performance of film-coated tablet and granule~     formulations of RG1662 under fed and fasted conditions in healthy volunteers. A randomized,~     four-period, four-treatment crossover design is used. In each period, each volunteer will~     receive a single oral dose of the tablet or granule formulation either with or without food.~   "
104906|NCT02194231|"~     The purpose of this study is to determine whether trabectedin is effective in the treatment~     of malignant pleural mesothelioma (MPM).~   "
104907|NCT02194218|"~     Study to determine the pharmacokinetic properties of 200 mg nevirapine (NVP) administered as~     4 x 50 mg extended release (XR) tablets in a single dose and to establish the bioequivalence~     of this formulation compared to 200 mg NVP administered as 2 x 100 mg XR tablets in a single~     dose~   "
104908|NCT02194205|"~     To compare the long-term (one-year) bronchodilator efficacy and safety of COMBIVENT~     hydrofluoroalkane (HFA) Inhalation Aerosol to COMBIVENT chlorofluorocarbon (CFC) Inhalation~     Aerosol and Placebo formulations of each in patients with COPD. In addition, steady state~     pharmacokinetics over one dosing interval following four weeks of therapy will be~     characterized.~   "
104909|NCT02194192|"~     Maternal hypotension after spinal anesthesia in parturients undergoing cesarean section is a~     very common problem leading to several complications to both patients and their babies. It~     can cause maternal discomfort, lightheadedness, nausea and vomiting. The most important~     complication is the decreasing blood flow to babies; which may lead to fetal acidosis.~      Many interventions has been studied in order to prevent hypotension after spinal anesthesia~     in cesarean section e.g., fluid loading: colloid vs crystalloid, medications: ephedrine,~     phenylephrine, and metaraminol, etc. The recent study showed ondansetron (the antiemetic~     drug) can be effectively used to prevent hypotension after spinal anesthesia in normal~     patients or parturients. The action of ondansetron is believed to inhibit Bezold-Jarish~     reflex.~      This aim of this study is to compare the efficacy of ephedrine and ondansetron in the~     prevention of maternal hypotension after spinal anesthesia in cesarean section.~   "
104910|NCT02194179|"~     The objective was to establish the pharmacokinetic (PK) profile at steady state of two~     different nevirapine (NVP) extended release (XR) formulations at 300 mg or 400 mg daily (QD)~     under fasted and fed conditions in comparison with the commercially available NVP immediate~     release (IR) tablet at 200 mg BID (400 mg/day).~   "
104911|NCT02194166|"~     This multicenter study in participants with HER2-positive eBC will investigate participants'~     pain and discomfort of SC trastuzumab (Herceptin) administered either via a single-use~     injection device (SID) or via vial for manual administration using a hand-held syringe (SC~     vial). In total, participants will obtain at least 18 cycles/1 year of trastuzumab (4 cycles~     of intravenous [IV] and 14 cycles of SC trastuzumab).~   "
104912|NCT02194153|"~     Obtaining data on efficacy (e.g. complete ST-segment resolution) depending on the time of~     treatment initiation and safety of prehospital and early hospital thrombolysis with Metalyse®~     in a real life setting outside clinical trials.~   "
104913|NCT02194140|"~     Rate of appendix localization on ultrasound is not high. We suggest a way to improve it's~     localization by oral administration of iodinated contrast material.~   "
104914|NCT02194127|"~     Study to determine the efficacy of Anthocyan to improve impaired twilight and night vision~     and to test its tolerability and safety.~   "
104915|NCT02194114|"~     The primary purpose of this study is to assess dietary protein requirements in clinically~     stable maintenance hemodialysis (MHD) patients. It is hypothesized that the average dietary~     protein intake (DPI) that will maintain nitrogen balance is 1.00 g protein/kg/day, but that a~     safe intake that maintains balance in almost all MHD patients is about 1.25g protein/kg/day.~   "
104916|NCT02194101|"~     This is an observational pilot study of supernormal oxygen delivery goal for patients with~     proximal femoral fracture.~   "
104917|NCT02194088|"~     This research study is being done to assess if a combination of medications can enhance the~     relief of superficial pain (pain at the surface of the skin, such as sunburn pain). The~     investigators also want to find out if certain genes may be linked to individual differences~     in experienced efficacy of pain killers. The combination of medications under investigation~     is diclofenac and atropine. Diclofenac has been approved by the U.S. Food and Drug~     Administration (FDA) to treat pain. Atropine has been approved by the FDA to treat certain~     types of poisoning, heartbeat problems, and other diseases but atropine is not approved to~     treat pain. However, atropine has been used for many years in different European countries to~     treat painful conditions such as stomach cramps.This research study will compare diclofenac~     and atropine to placebo.~   "
104918|NCT02194075|"~     Explore the efficacy of methylphenidate hydrochloride controlled-release tablets add-on~     pharmacotherapy on clinical symptomatology and cognitive functioning in a sample of patients~     with obsessive-compulsive disorder (OCD) receiving fluvoxamine maleate. To test the~     hypothesis that methylphenidate hydrochloride controlled-release tablets augmentation of~     fluvoxamine treatment is well tolerated and may be proposed as an effective therapeutic~     strategy to improve outcome in OCD.~   "
104919|NCT02194062|"~     The purpose of this study is to compare intranasal fluticasone spray with budesonide nasal~     saline rinses in both the upright and head forward positions in patients who have had~     functional endoscopic sinus surgery (FESS) for chronic rhinosinusitis with nasal polyposis~     (CRSwNP) and measure differences in Sinonasal Outcome Test-22 (SNOT-22) scores and Lund-~     Kennedy scores on rigid nasal endoscopy at time points 1 week, 3 weeks, 6 weeks, 2 months, 4~     months, and 6 months post-op.~   "
104920|NCT02194049|"~     This phase I trial studies the side effects and the best dose of PI3K inhibitor BKM120 when~     given together with cisplatin and etoposide in treating patients with advanced solid tumors~     or small cell lung cancer. Drugs used in chemotherapy, such as cisplatin and etoposide, work~     in different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing , or by stopping them from spreading. PI3K inhibitor BKM120 may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving PI3K~     inhibitor BKM120 with cisplatin and etoposide may kill more tumor cells.~   "
104921|NCT02194036|"~     Outpatients that suffer from different anxiety disorders may have physical ailments that~     negatively affect daily life functioning and quality of life. LOF is a physical therapy~     approach focusing on the link between bodily and mental balance and through defined, but~     simple movements, patients are expected to learn how to cope and reduce health complaints.~      This study aims to investigate the short- and longterm effect of LOF compared to other~     standardized psychiatric treatments given in the clinic on levels of anxiety and depression,~     health related function and quality of life.~   "
104975|NCT02193334|"~     This study is randomized, double-blind, placebo-controlled Phase I/II study designed to~     evaluate safety and efficacy of KP-100IT, code of Hepatocyte Growth Factor (HGF) formulation~     for intrathecal injection, as a treatment for acute spinal cord injury. The study is~     conducted at two clinical sites in Japan.~   "
104922|NCT02194023|"~     In the current study we tested the hypothesis that new 0.05% Cetylpyridinium chloride (CPC)~     mouthrinse formulations containing 0.12% or 0.03% chlorhexidine digluconate (CHX): 1) yield~     similar or better clinical results regarding the inhibition of de novo plaque growth compared~     to those achieved with an already marketed 0.12% CHX mouthrinse (Perio-Aid Treatment without~     alcohol. Dentaid, Spain), 2) reduce the side effects caused by the marketed 0.12% CHX formula~     and 3) that these mouthrinses have no negative microbiological effects, and they control~     total bacterial loads.~   "
104923|NCT02194010|"~     The purpose of this research study is to create and validate two patient reported outcome~     (PRO) questionnaires. PRO questionnaires ask questions that help to measure disability in~     patients with inherited neuropathies. These questionnaires ask questions about what~     participants think disability is for themselves or others with inherited neuropathies. These~     questionnaires are a useful tool when evaluating whether treatments are working in the day to~     day life of an individual, although there are currently no questionnaires available~     specifically for people who have Charcot Marie Tooth disease (CMT).~   "
104924|NCT02193997|"~     This study examines the effects of dietary fiber in the treatment of functional childhood~     constipation.~   "
104925|NCT02193984|"~     Alliance to Control Diabetes was a 2.5-year study funded by the American Academy of Family~     Physicians Foundation. The study was designed to help patients better manage their diabetes,~     and was a partnership between the Institute for Behavioral and Community Health and Clínicas~     de Salud del Pueblo, Inc (CDSDP), a private, non-profit corporation providing comprehensive~     primary care services to residents throughout Imperial and Riverside Counties, California.~     The investigators identified 336 patients with uncontrolled diabetes from three CDSDP~     clinics. Patients were randomly assigned to intervention or control conditions. The 12-month~     intervention consisted of individual diabetes management support delivered by a trained~     volunteer peer supporter. The primary aim was determine if peer support can help patients~     better manage their diabetes and improve the quality of their lives. Intervention~     effectiveness was evaluated through volunteer and patient surveys at baseline, 6 months and~     12 months. This study was part of the global Peers for Progress network which has been~     testing peer support programs in 13 countries.~   "
104926|NCT02193971|"~     -  Study objectives~             1. To compare the safety and long-term efficacy of coronary stenting with biostable~               polymer drug-eluting stent (Promus PremierTM, Xience Alpine®, Resolute Onyx®) with~               biodegradable polymer drug-eluting stent (Biomatrix®, Biomatrix Flex®, Nobori®,~               Ultimaster®, Synergy ® and Orsiro®) in patients with acute coronary syndrome~             2. To compare the efficacy and safety of 5 mg prasugrel maintenance therapy compared~               with 10 mg prasugrel maintenance therapy in patients with acute coronary syndrome~               undergoing percutaneous coronary intervention~        -  Study design :~      Prospective, open-label, 2-by-2 multifactorial, randomized, multicenter trial to test the~     following in CHD patients~        1. Non-inferiority of biostable polymer drug-eluting stent (Promus PremierTM, Xience~          Alpine®, Resolute Onyx®) compared with biodegradable polymer drug-eluting stent~          (Biomatrix®, Biomatrix Flex®, Nobori®, Ultimaster®, Synergy ® and Orsiro®) in terms of~          patient-oriented composite outcome~        2. Non-inferiority of 5 mg compared to 10 mg dose of prasugrel maintenance in terms of~          major adverse cardiovascular events~   "
104927|NCT02193958|"~     A Phase 1/2a Dose Escalation Study of FF-10501-01 in Patients with Relapsed or Refractory~     Hematological Malignancies to determine the safety and tolerability. A total of 6 cohorts~     will be enrolled in Phase 1 to establish the MTD. A total of 20 subjects with MDS/CMML~     treated at the RP2D are planned, including MDS/CMML subjects treated at the RP2D in Phase 1.~   "
104928|NCT02193945|"~     The purpose of this study is to retrospectively review and further characterize anatomic and~     symptomatic changes over six months immediately following treatment of symptomatic~     vitreomacular adhesion (VMA) with JETREA® (ocriplasmin), including incidence, time to onset~     and resolution of anatomy and symptoms.~   "
104929|NCT02193932|"~     A prospective exploratory study in patients with drug resistant epilepsy with a target~     comparison of long term outcome. NeuroScan software modules and a MagLink will be used to~     acquire EEG in combination with MRI/fMRI data. The MagLink system is used for obtaining~     integrated EEG and Event Related Potential (ERP) recordings while the subject is inside the~     MRI machine, without compromising the raw EEG data.~   "
104930|NCT02193919|"~     Weight loss may help psoriasis. Phototherapy helps psoriasis. Combining the two treatments~     may help even more. Determining if a high protein diet vs a low protein diet results in~     improving psoriais may help lead to future dietary effects on psoriasis therapy~   "
104931|NCT02193906|"~     The purpose of the study is to determine the effect of an web-based intensive cognitive~     rehabilitation program in neuropsychological performance of a population of patients with~     multiple sclerosis or clinical isolated syndrome.~   "
104932|NCT02193893|"~     The purpose of this study is to test the safety and effectiveness of an autologous bone~     marrow-derived stem/progenitor cells infusion in the subjects with diagnosed amyotrophic~     lateral sclerosis.~   "
104933|NCT02193880|"~     The purpose of this study is to determine the safety and efficacy of post-transplant~     cyclophosphamide and a post-transplant infusion of donor cells, that have been specially~     processed to remove alpha beta t-cells, in patients undergoing a haploidentical allogeneic~     stem cell transplant to help reduce the risk of relapse without increasing the risk of~     graft-versus-host disease.~   "
104934|NCT02193867|"~     This is an open-label, repeat-dose, study of sebelipase alfa in infants with rapidly~     progressive LAL Deficiency. Eligible subjects will receive once-weekly infusions of~     sebelipase alfa for up to 3 years.~   "
104976|NCT02193321|"~     The purpose of this study is to to evaluate the rate of new onset postoperative atrial~     fibrillation in subjects receiving the amniotic membrane patch placed on the epicardial~     surface as compared to subjects who did not undergo epicardium intervention.~   "
104977|NCT02193308|"~     To demonstrate the bioequivalence of 80 mg telmisartan / 10 mg amlodipine fixed dose~     combination (FDC) vs. its monocomponents~   "
104978|NCT02193295|"~     The purpose of this study is to examine whether weight reduction decreases intramyocellular~     (IMCL) and hepatic lipid content, and improves insulin sensitivity of muscle and fat tissue~     in people who are insulin resistant and have a family history of type 2 diabetes.~   "
104935|NCT02193854|"~     Objective This study is aimed to estimate the distance, time and the cost of travel saved by~     patients who are seeking tele-dermatology (TD) service though smart mobile phones in the~     resource poor settings at the rural clinics of Mongolia.~      Methods A cluster-randomised trial was conducted for six months at the 20 rural health~     clinics selected from three districts in Mongolia. With a computer-generated sequence, health~     clinics were randomly allocated either to the intervention group, in which all general~     practitioners (GPs) received TD consultation through Sana system, or the control group, in~     which GPs referred patients to the dermatologist at district hospital whenever needed. The~     primary outcome was to estimate the distance traveled, times spend and the cost of travel~     required in receiving dermal care for patients in rural Mongolia. Analysis was done to~     estimate the difference between the aforementioned parameters among intervention and control~     groups.~   "
104936|NCT02193841|"~     Simple bone cysts (SBCs) are cysts filled with fluid that occur most frequently in the long~     bones (arms or legs) of children. There are many ways to treat SBCs but it is unclear if one~     is better than another. The purpose of this research trial is to compare the effectiveness of~     two common treatments that are used by surgeons today.~   "
104937|NCT02193828|"~     The objectives of this study are to assess the safety and effectiveness of AA4500 in treating~     palmar Dupuytren's disease nodules.~   "
104938|NCT02193815|"~     This is a vehicle and comparator controlled Proof of Mechanism (PoM) trial to evaluate the~     effect on psoriasis disease activity and safety of topically applied PF 06263276 in subjects~     with psoriasis vulgaris.~   "
104939|NCT02193802|"~     The utility of capsule endoscopy in diagnosing small bowel (SB) Crohn's disease has been~     demonstrated in a number of studies.~      Mucosal healing is a good predictor of long term remission. Unfortunately, the assessment of~     small bowel mucosal healing by conventional colonoscopy is an invasive technique which is not~     complete since it does not allow exploration of the small bowel beyond the terminal ileum~     (TI). Thus, direct evidence of the healing of the majority of the small bowel is lacking.~   "
104940|NCT02193789|"~     In patients of subtotal gastrectomy with Billroth-I or Billroth-II anastomosis, Anastomosis~     site stricture is very severe complication. It can improve by temporary through the scope~     covered metallic stent. It is very effective procedure about the stricture. But stent~     migration is very severe complication. Herein the investigators suggest newly method to~     prevent the stent migration. Fixation of stent by hemoclip is effective method to prevent~     stent migration. But it is difficult to remove stent after resolved stricture. So the~     investigators add the suture between hemoclip and stent. And the investigators cut the suture~     when stent removal.~   "
104941|NCT02193776|"~     The purpose of this study is to determine the mycobactericidal activity of combinations of~     bedaquiline (J), moxifloxacin (M), PA-824 (Pa) and pyrazinamide (Z) regimens during 8 weeks~     of treatment.~   "
104942|NCT02193763|"~     This is a prospective, randomized study evaluating the efficacy of bedside ultrasound~     assisted lumbar puncture in pediatric patients~   "
104943|NCT02193750|"~     The investigators hypothesize that a novel method for oligosaccharide supplementation, in the~     form of nutritional bars and/or muesli high in fructans and galacto-oligosaccharides (GOS),~     will be a safe and tolerable therapeutic intervention in patients with Crohn's disease (CD)~     in remission.~   "
104944|NCT02193737|"~     National guidelines about post-operative fasting after general anesthesia are missing.~      Current clinical practices are highly variable and no study has ever evaluated on a large~     scale the real risk of an early drinks recovery in postoperative period.~      The aim of this study is to state the impact of early drinks recovery after general~     anesthesia with laryngeal mask or endotracheal intubation on the risk of aspiration.~   "
104945|NCT02193724|"~     The goal of this study is to determine if human RB1-deficient induced pluripotent stem cells~     (iPSCs) can produce retina, and, furthermore, can give rise to retinoblastoma in culture.~     This unique opportunity to study the initiation of retinoblastoma in the developing retina~     will shed light on the cell of origin for retinoblastoma and allow the investigators to study~     the earliest molecular and cellular events in retinoblastoma tumorigenesis.~      OBJECTIVES:~        -  To establish the feasibility of producing induced pluripotent stem cells (iPSCs) from~          retinoblastoma patients with germline RB1 mutations (RB1-deficient iPSCs).~        -  To validate human RB1-deficient iPSCs by confirming karyotype, pluripotency and RB1~          mutation.~        -  To differentiate the RB1-deficient iPSCs into retina as a model of the initiation of~          retinoblastoma in the developing retina.~   "
104946|NCT02193711|"~     The current clinical trial is designed to test the analgesic and anti-inflammatory efficacy~     of a topical cream compared to a placebo cream. The study population will be those with mild~     to moderate osteoarthritis of the knee.~      The trial will also provide information about potential side effects and verify the safety of~     this composition. Blood levels will be done to assess inflammation and to determine whether~     any systemic absorption has occurred.~      Hypothesis/Purpose~        -  Pain scores after active treatment will be significantly reduced in comparison to~          placebo.~        -  There will be an improvement in stiffness and physical function as measured by the WOMAC~          using the active cream as compared to placebo.~        -  There will be a decrease in the level of inflammation assessed at baseline, end of week~          3 and end of week 6.~        -  The blood concentration of the active ingredient in the topical cream will not exceed~          the maximum daily dose that will be consumed by participants.~   "
104947|NCT02193698|"~     This study investigates the efficacy and safety of Lenalidomide as a treatment for recurrent~     or refractory POEMS (Crow-Fukase) syndrome.~   "
104979|NCT02193282|"~     This phase III ALCHEMIST trial studies how well erlotinib hydrochloride compared to~     observation works in treating patients with stage IB-IIIA non-small cell lung cancer that has~     been completely removed by surgery. Erlotinib hydrochloride may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth.~   "
104980|NCT02193269|"~     To determine minocycline's effects on cognitive performance and measures of mood in abstinent~     cocaine users. Minocycline is a tetracycline derivative antibiotic that also inhibits~     microglia activation and the release of pro-inflammatory cytokines, chemokines, and nitric~     oxide (NO) production. Previous animal and human studies suggest that minocycline may have~     utility as a treatment for cocaine addiction.~   "
129239|NCT01875770|"~     This research is being done to assess the long term prognosis of patients treated with~     ranibizumab for edema due to retinal vein occlusion.~   "
104948|NCT02193685|"~     To identify demographic, clinical, genetic, immunologic and/or microbial (i.e., fecal stream~     characterization) risk factors that influence the likelihood of development of the HAEC~     phenotype in children who carry the diagnosis of HD. The newly formed HAEC Collaborative~     Research Group (HCRG) will utilize the 4 participating centers in the current consortia and~     recruit additional centers to enroll children diagnosed with Hirschsprung disease.~      1a: To recruit 200 patients with Hirschsprung disease without HAEC.~      1b: To recruit 200 patients with Hirschsprung disease and HAEC using standardized diagnostic~     criteria by collaborating with participating members of the HAEC Collaborative Research~     Group[1].~      1c: To collect clinical and demographic information from well-characterized HD patients both~     with and without HAEC.~      1d: To collect samples blood for DNA for genome wide association study (GWAS) by high~     throughput SNP technology and mutational analysis of known HSCR genes.~      1e: To collect serum samples at the time of recruitment in a subset cohort (n=50 HD only,~     n=50 HD + HAEC) for serological immune markers known for inflammatory bowel disease (IBD)~     including ANCA, ASCA, OMPC, I2, and CBir1 and any newly identified markers.~      1f: To collect and store fresh fecal specimens for future evaluation by molecular~     methodologies to determine relative proportions of enteric microflora in a subset cohort~     (n=50 HD only, n=50 HD + HAEC) of children (<18 years).~      1g: To establish a Centralized Data Coordinating Center for data collection, data quality and~     detailed data analyses (CSMC) and tissue bank (CSMC) to facilitate specimen analysis for this~     study.~      The HAEC risk factor identification will be completed by multivariate logistic regression~     analysis. Genetic association will be studied for each SNP in the GWAS together with all~     other potential risk factors. Further analysis will be carried out to evaluate multiple~     SNPs/genes simultaneously.~   "
104949|NCT02193672|"~     The goal of this clinical research study is to find out if using the tracer (liquid used in~     imaging scans) [18F]fluciclatide in positron emission tomography / computed tomography~     (PET/CT) scans will help researchers learn more quickly if the disease is responding to~     treatment.~   "
104950|NCT02193659|"~     The inclusion of breakfast cereals enriched with omega-3 for female users of a pharmacy who~     had some lipidic profiles to the limit is highly conditioned by their nutritional acceptance.~     The main objective is to assess the effect of breakfast cereals intake with omega-3 on women~     lipid profile values to the limit, users of a pharmacy in Elche and in this way reduce the~     small dyslipidemia.~   "
104951|NCT02193646|"~     The investigators are retrospectively comparing detection rates of adenomatous polyps,~     advanced adenomas, and size assessment of the polyps among Rush University Medical Center~     endoscopists. The investigators plan to review whether the size assessment of adenomatous~     polyps affected the surveillance protocols and if the location of polyps detected affected~     the detection rates.~   "
104952|NCT02193633|"~     This is a Phase I study to evaluate the safety and toxicity profile of AZD2014, a novel~     anticancer agent, in combination with paclitaxel.~      AZD2014 will be given orally, twice daily at a starting dose of 25 mg per day for 3 days on,~     4 days off with a weekly infusion of 80 mg of paclitaxel for 6 weeks followed by a treatment~     break of one week, therefore each cycle will be 7 weeks long. Cohorts of three patients will~     be treated at this dose of AZD2014 and then at 50mg and 75 mg providing is it safe to do so.~     Once we have determined the maximum tolerated dose (MTD) using the 3 days on, 4 days off~     schedule of AZD2014, patients will be given AZD2014 2 days on, 5 days with their paclitaxel~     infusion. Patients will be enrolled in cohorts of three to evaluate three escalating doses of~     AZD2014 to determine the MTD for the 2 days on, 5 days off schedule.~      On completion of the dose escalation phase of the study patients with ovarian cancer and~     squamous cell lung cancer will be treated at the MTD established for each dosing schedule. A~     minimum of 10 ovarian cancer patients and 15 squamous cell lung patients will be enrolled to~     the 3 days on, 4 days off schedule. Whilst a minimum of 10 squamous cell cancer patients will~     be enrolled to the 2 days on, 5 days off schedule to further assess the tolerability of the~     combination of AZD2014 and paclitaxel.~   "
104953|NCT02193620|"~     The purpose of this study is to assess the effectiveness, safety and pharmacokinetics of Oral~     Nalbuphine in the treatment of postoperative pain following hemorrhoidectomy.~   "
104954|NCT02193607|"~     1. To evaluate whether a standardized tension-free vaginal tape-obturator(TVT-O) procedure,~          when added to a planned improved reconstruction pelvic surgery, improves the rate of~          urinary stress continence in subjects with occult stress incontinence.~        2. Observe the immediate and short-term complications, overall urinary tract function, and~          other aspects of pelvic health between subjects with and without a TVT-O procedure.~   "
104955|NCT02193594|"~     Preoperative chemoradiotherapy(CRT) had been introduced in the comprehensive treatment of~     gastroesophageal junction and upper gastric cancers in the decade.According to some~     researches,CRT had shown its good curative effects in local control and prolonged overall~     survival.However,the optimization scheme for CRT and its influence to surgery remains~     controversial.Meanwhile,there were many design flaws in the past few research,such as the~     lack of adjuvant chemotherapy,the insufficiency in lymphnodes dissection.We decided to carry~     out the trial,eliminating all the bias as far as we can,to illustrate the efficacy and safety~     of CRT.~   "
104956|NCT02193581|"~     The use of MDS to access the presence of melanoma in the skin.~   "
104957|NCT02193568|"~     This randomized clinical trial studies light sedation compared with intubated general~     anesthesia (a loss of feeling and a complete loss of awareness that feels like a very deep~     sleep) in reducing complications and length of hospital stay in patients with brain cancer~     undergoing craniotomy. Craniotomy is an operation in which a piece of the skull is removed so~     doctors can remove a brain tumor or abnormal brain tissue. Light sedation allows patients to~     remain awake during their surgery, while intubated general anesthesia puts patients to sleep.~     Surgery complication rates may be reduced if intubated general anesthesia is avoided.~     Additionally, patients not receiving intubated general anesthesia tend to recover more~     quickly after surgery. It is not yet known whether light sedation is better at reducing~     complications and length of hospital stay compared to intubated general anesthesia.~   "
104958|NCT02193555|"~     The aim of this study is to assess the visual performance of prototype soft contact lens~     designs compared to a commercially available contact lens~   "
105016|NCT02192801|"~     Patients with classical bladder exstrophy undergo many surgical interventions with secondary~     urinary tract infections complicating their course. lately primary definitive surgical~     correction of this congenital anomaly has been implemented with satisfactory results.~     Although bladder exstrophy patients are born with normal kidneys, infectious and mechanical~     surgical complications can potentially damage their kidneys in the long-term. therefore we~     decided to evaluate renal function in the long-term in these patients.~   "
105094|NCT02191761|"~     This is an open-label, multi-center, dose escalation study in adult subjects with advanced~     colorectal, gastric, hepatic or pancreatic cancer. The study will evaluate the safety,~     tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of SM04755 administered orally.~     Upon determination of the maximum tolerated dose (MTD), expansion cohorts may be enrolled.~   "
104959|NCT02193542|"~     Anesthesiologists commonly administer pain relief during labor or providing anesthesia for~     cesarean delivery. Two main methods are used to achieve these goal: Regional anesthesia~     where the mother is given medication through a needle or catheter in her back and the mother~     is kept awake, or General anesthesia, where the mother is given intravenous medication and~     is kept asleep.~      Regional anesthesia uses a needle to enter a narrow space in the mother's back where~     medications can be given. In some patients, it takes longer to find this target space in the~     back. In emergency situation, however, there is often little time to find this space, and the~     backup method would be the general anesthesia technique.~      If general anesthesia is required, a breathing tube needs to be inserted to help support the~     mother's breathing. In some patients, it is harder to insert the breathing tubes, so knowing~     this in advanced helps anesthesiologists create a safe plan for the patients. A lot of~     research has been done to determine factors that would predict which patients would need more~     time and preparation for general anesthesia and regional anesthesia.~      The purpose of this study is to study how common it is for the pregnant patients who have a~     difficult regional and general anesthesia.~   "
104960|NCT02193529|"~     Weight reducing surgery is the only effective therapy for morbid obese patients.~      Sleeve gastrectomy is a popular choice for bariatric surgery because of less sequela. There~     is poor knowledge about the nutritional status inpatients after LSG. The aim of our study was~     to investigate the relationship between dietary intake and weight loss after LSG.~   "
104961|NCT02193516|"~     Corticomedullary differentiation (CMD) abnormality (absent/reversed) is a parameter that can~     indicate possible nephropathy. The evolution of CMD across gestation had not been well~     established. Devrendt et al demonstrated the presence of CMD in all fetuses older then 20~     weeks. In our study we would like to determine the exact timing of it's sonographic~     visualisation. This is a prospective study recruiting women between 14-24 week gestation~     during routine ultrasound screening. A midsagittal image of each kidney will be taken by a~     single sonographer and examined for the presence of the CMD by two other sonographers blinded~     to gestational age.~   "
104962|NCT02193503|"~     The objectives are to assess the safety and tolerability of 6 vaccine doses of MVX-ONCO-1,~     administered sub-cutaneously (injections and capsules implantations), in patients with~     advanced metastatic solid tumor in progression who are not or not any longer amenable to any~     standard therapy of their tumour disease.~   "
104963|NCT02193490|"~     The purpose of this study is to evaluate the tolerability and preliminary efficacy of DNase~     eye drops in patients with Sjogren's and Non-Sjogren Dry Eye Disease.~   "
104964|NCT02193477|"~     The purpose of this study is to access the effect of Transcutaneous Electrical Acupoint~     Stimulation(TEAS) on the Incidence rate of Systemic Inflammatory Response Syndrome (SIRS) in~     patients undergoing radical surgery for gastric cancer~   "
104965|NCT02193464|"~     The purpose of this study is to investigate the incidence and natural course of inflammatory~     bowel disease in the southeastern area of Korea.~   "
104966|NCT02193451|"~     Some men develop difficulty passing urine (voiding) as they age. This may be because an~     enlarged prostate gland (which sits round the base of the bladder) narrows the bladder outlet~     (urethra) or because the bladder becomes less able to contract. Prostate surgery is more~     likely to help symptoms in the first group, while the second group may have no improvement~     after surgery, while being exposed to risk of complications of surgery.~      Invasive urodynamics involves putting a tube (catheter) into the bladder via the penis, and~     another into the rectum, to measure bladder and abdominal pressures while the bladder is~     filled with a sterile fluid. Invasive urodynamics can measure bladder pressures during~     filling and voiding, and bladder outlet obstruction pressures. The procedure is considered~     safe, but some men find it uncomfortable or undignified, and a few develop urine infection~     afterwards. We think that it could be useful to select the men who should and should not have~     surgery. However, no studies have been conducted so far to tell us if this is true: UPSTREAM~     is designed to find out if the invasive tests are worthwhile.~      UPSTREAM is a randomised controlled trial in men who have bothersome difficulty passing urine~     and who are considering having surgery for the symptoms. The group studied will be men who~     continue to be bothered by difficulty passing urine, despite initial treatment such as drugs,~     where symptoms are thought to be due to bladder outlet obstruction. The men will be assigned~     at random to either invasive urodynamic tests as well as the standard tests (Invasive~     urodynamics) or to the routine standard tests (Usual care control arm) alone. Routine~     standard tests include asking men to complete a questionnaire (the International Prostate~     Symptom Score (IPSS)) and a bladder diary, carrying out flow rate testing, and checking the~     urine for infection. Some surgeons also use discretionary tests such as the PSA~     cancer-screening blood test.~      The following men will be invited to participate (inclusion criterion);~      • Men considering undergoing surgery as a treatment option for bothersome urinary symptoms~      Men will not be invited to participate (exclusion criteria) if they:~        -  are unable to pass urine without a catheter (urinary retention)~        -  have a relevant neurological disease, such as a stroke~        -  are undergoing treatment for prostate or bladder cancer~        -  have previously had prostate surgery~        -  are not medically fit for surgery, or are unable to complete outcome assessments~        -  do not consent to be assigned at random to one of the pathways We will compare the two~          methods of investigation by finding out whether the men had similar relief of their~          symptoms, by measuring the change in the prostate symptom score (IPSS) in the two groups~          at 18 months after randomisation.~      We will also look at the following secondary outcomes:~        -  Whether the invasive tests changed the decision for surgery in some of the men (how many~          men had surgery in each of the two groups?)~        -  The cost-effectiveness of the two management pathways~        -  Adverse effects of (a) the tests and (b) the treatments at 6, 12 & 18 months (e.g.~          urinary infection, urinary retention)~        -  Urinary symptoms at 6, 12 & 18 months, using the International Consultation on~          Incontinence Questionnaires (ICIQ) and the Male Lower Urinary Tract Symptoms~          questionnaire (ICIQ-MLUTS)~        -  Quality of life, using the ICIQ-QoL questionnaire~        -  Sexual function, using the ICIQ-MLUTS sex questionnaire~        -  Satisfaction with urodynamic testing, using the ICIQ-UDS-S questionnaire~        -  The maximum urinary flow rate (Qmax) at 18 months~        -  Health outcomes, using the EQ-5D-5L questionnaire~   "
104967|NCT02193438|"~     Human studies have shown that capsaicin, a compound extracted from chilly peppers, can~     stimulate certain physiologic functions (for example, energy expenditure, thermogenesis,~     lipid oxidation, heart rate, etc.).~      The purpose of this study is to measure the impact of ingesting various spicy molecules on a~     set of physiologic parameters compared to a placebo. The molecules were selected for their~     different sensory properties.~      The results of this study will allow us to implement an effective method for measuring the~     impact of ingesting spices on certain body functions (for example, metabolism and autonomic~     nervous system activity). This study will also allow us to identify the beneficial properties~     of eating certain spices.~   "
104968|NCT02193425|"~     Background:~      - Magnetic resonance imaging (MRI) is used to investigate brain function. Researchers want to~     use MRI to better understand the function patterns and connections between brain regions in~     healthy people. This might help people with brain diseases in the future.~      Objectives:~        -  To evaluate MRI methods performed twice on the same day.~        -  To evaluate brain function using positron emission tomography (PET).~      Eligibility:~      - Healthy volunteers at least 18 years old.~      Design:~        -  Visit 1:~        -  Participants will be screened with medical history, physical exam, and interview about~          drug and alcohol use and psychiatric history.~        -  They will give blood and urine samples. Their breath will be tested for alcohol and~          smoking.~        -  Visit 2:~        -  Participants will have urine collected. They will have MRI scans, some while resting,~          some while doing tasks on a computer.~        -  The MRI scanner is a metal cylinder in a strong magnetic field. Participants will lie on~          a table that slides in and out of the cylinder, with a coil over their head.~          Participants will get earplugs for loud noises.~        -  Visit 3:~        -  Participants will have urine collected.~        -  A needle will guide a thin plastic tube (catheter) into each arm. The needle will be~          removed, leaving the catheter in the vein.~        -  Participants will then have a PET scan. They will get the chemical 18FDG in the~          catheter. They will lie on a bed that slides in and out of the PET scanner, with a cap~          on their head.~        -  Participants may have tests of memory, attention, concentration, and thinking. They may~          complete interviews, questionnaires, tests on paper or computer, and simple actions.~        -  Participants will wear a device for 1 week between visits to measure activity and sleep.~   "
104969|NCT02193412|"~     The purpose of this study is to determine whether the value of analgesia nociception index~     (ANI) is influenced by variations of systemic venous return (cardiac preload) under general~     anaesthesia.~   "
104970|NCT02193399|"~     Research project with patients undergoing allogeneic hematopoietic transplantation in the~     hematology and hemotherapy Clinical Hospital Universitario Virgen de la Arrixaca. The main~     objective is to assess the differences in skeletal muscle and functional variables in the~     experimental group underwent a physiotherapy treatment that takes place during the pre-and~     post-transplant period, compared to a control group.~   "
104971|NCT02193386|"~     The study aims to evaluate evidence-based practice behavior in usual care physical therapy in~     Flanders. Secondly, it aims to compare the effectiveness of a predefined physical therapy~     program based on evidence-based guidelines to the effects of a period of usual care. It is~     hypothesized that supporting therapists by providing a predefined evidence-based intervention~     program, will result in an improved treatment outcome compared to the usual care physical~     therapy.~   "
104972|NCT02193373|"~     The purpose this study is to determine which manual medicine technique or combination of~     techniques has the greatest effect on the natural changes in heart rate.~   "
104973|NCT02193360|"~     The purpose of this study is to determine the initial safety, tolerability and~     pharmacodynamics of the CD40-antagonist Mab, FFP104, in subjects with PBC~   "
104974|NCT02193347|"~     Potential subjects with progressive Grade II primary brain tumor that have IDH1 positive~     testing from the primary tumor (initial diagnosis) will be offered this treatment study in~     order to test the safety of the PEPIDH1M vaccine in combination with standard chemotherapy~     (temozolomide).~   "
104981|NCT02193256|"~     The purpose of this study is to examine the effect of varenicline and prazosin on smoking,~     drinking, and sleep among cigarette smokers who report heavy alcohol use. Varenicline is an~     FDA approved smoking cessation medication. Some smokers report sleep problems when taking~     varenicline. This study will test whether using prazosin, which is an FDA-approved blood~     pressure medication, in combination with varenicline reduces sleep problems that can be~     associated with using varenicline for smoking cessation. In addition, the study will examine~     the combined effects of these medications on smoking and drinking.~      Hypothesis: Varenicline plus prazosin will result in lower rates of vivid dreams and insomnia~     symptoms/sleep discontinuity than varenicline alone prior to the 3-day practice quit attempt.~      Hypothesis: Varenicline plus prazosin will result in lower rates of vivid dreams and insomnia~     symptoms/sleep discontinuity than varenicline alone during the 3-day practice quit attempt.~   "
104982|NCT02193243|"~     The six-minute walk test is an established submaximal exercise test. Its role in examination~     of grown-up patients with congenital heart disease (GUCH) is not studied so far. Objective of~     this study was a comparison of the 6MWT with other established parameters of functional~     capacity, in grown-up patients with GUCH.~   "
104983|NCT02193230|"~     Atopic dermatitis is a chronic inflammatory skin disease often occurring in childhood.~      The treatment consists in making daily local treatment with topical steroid on inflammatory~     lesions and emollient on the whole body. However, approximately 70% of patients do not adhere~     to therapy.~      Studies have shown that this treatment failure is caused by the complexity of the treatment,~     the time required for its implementation, the cost of treatment, the dosage of the products,~     fear of side effects or misunderstanding about the chronicity of these diseases inflammatory~     conditions of the skin.~      This study aims to evaluate the consideration of patient preference in the choice of~     excipient used for the topical treatment of eczema.~   "
104984|NCT02193217|"~     The purpose of this study is to explore the cardiac pharmacodynamics, safety and tolerability~     of MT-1303 in healthy subjects.~   "
104985|NCT02193204|"~     The purpose of this study is to examine potential stress and immune systems adaptations~     underlying craving and relapse vulnerability in alcohol dependent (AD) individuals and social~     drinkers (SDs) with and without high levels of depressive symptomatology (+dep / - dep).~     Using the investigators experimentally validated guided imagery procedure, the investigators~     propose to examine the response of brain stress and immune systems to personalized guided~     stressful imagery using subjective, physiological and neurobiological assessments in 60~     healthy controls and 60 alcoholic dependent individuals with and without depressive~     symptomatology.~   "
104986|NCT02193191|"~     The purpose of this research study is to test the safety and efficacy of a drug called~     Plerixafor. Plerixafor is approved by the US FDA for use in increasing blood stem cell counts~     before collection in cancer patients. It is not yet approved for patients with sickle cell~     disease. The investigators want to find out if Plerixafor can be used to increase cell counts~     in patients with sickle cell disease.~   "
104987|NCT02193178|"~     The study hypothesis is that the Biofinity Toric XR lenses will perform as well as or better~     than the participants' habitual contact lenses. Further, that a minimum of 80% of those~     enrolled will complete 2 weeks of lens wear with no contraindication to continue.~   "
104988|NCT02193165|"~     The objective of this clinical research study is to assess the efficacy of three oral hygiene~     multi-component regimens encompassing the use of a manual toothbrush, toothpaste and a~     mouthwash in controlling established dental plaque and gingivitis.~   "
104989|NCT02193152|"~     The purpose of this study is to evaluate how participants with advanced non-small cell lung~     cancer (NSCLC) that have certain abnormalities in the pazopanib target genes respond to~     pazopanib treatment.~   "
104990|NCT02193139|"~     This Phase 2 study is designed to evaluate multiple doses of an anticholinergic-containing~     medication and identify the dose or doses that may effectively reduce axillary sweating in~     hyperhidrotic subjects. The anticholinergic agent being studied is designated WL8713.~   "
104991|NCT02193126|"~     The Trauma Focus Model for Reducing Long-Term Foster Care Project with the Illinois~     Department of Children and Family Services (DCFS) is implementing a trauma-focused~     intervention, Trauma Affect Regulation: Guide for Education and Therapy (TARGET) to increase~     permanency rates for a target population of children identified as being most at risk of~     long-term foster care.~   "
104992|NCT02193113|"~     This is a Phase 1 study to investigate the safety, tolerability of the novel plasma~     kallikrein inhibitor, KVD001 in subjects with diabetic macular edema. The study is the first~     step to investigate the hypothesis that plasma kallikrein plays an important role in the~     disease process behind diabetic macular edema in many patients~   "
104993|NCT02193100|"~     To characterize the metabolism of glucose by the leukemic cells in patients with leukemia~     before and after initial chemotherapy.~      To compare the metabolism of glucose by leukocytes in healthy volunteers and leukemic cells~     in leukemic patients.~   "
104994|NCT02193087|"~     The purpose of this study is to evaluate the equivalence of the lyophilized formulation of~     Takeda's Tetravalent Dengue Vaccine Candidate (TDV) compared with the liquid formulation of~     TDV.~   "
104995|NCT02193074|"~     The primary objective of the study is to examine the clinical efficacy of nusinersen (ISIS~     396443) administered intrathecally (IT) to participants with infantile-onset with~     infantile-onset spinal muscular atrophy (SMA). The secondary objective of the study is to~     examine the safety and tolerability of nusinersen administered intrathecally to participants~     with infantile-onset SMA.~   "
105013|NCT02192840|"~     Coronary bifurcation lesions pose therapeutic problems during percutaneous coronary~     interventions (PCI) and are associated with higher rates of periprocedural complications as~     well as higher rates of in-stent restenosis and stent thrombosis. Therefore the optimal~     approach to coronary bifurcations treatment is still a subject of debate, especially when the~     side branch is large, not easily accessible and narrowed by a long lesion. One of the~     proposed alternatives are dedicated bifurcation stents (DBS). However, there is large~     scarcity of randomized trials with DBS.~      The aim of POLBOS I (POLish Bifurcation Optimal Stenting) study was to compare two~     intervention strategies for bifurcation treatment: provisional T-stenting (PTS) with any~     regular drug-eluting stent (rDES), the best treatment strategy at the moment, with stenting~     of bifurcation lesions with dedicated bifurcation paclitaxel-eluting stent BiOSS Expert®~     (Balton, PL).~   "
104996|NCT02193061|"~     Assess the immunological behavior of children from 2 months of age that receive one out of~     seven anti-rotavirus vaccination programs: Group 1 (routine schedule with two doses of RV1 -~     Rotarix plus sterile water) and Group 2 (routine schedule with three doses of RV5 - RotaTeq)~     versus Group 3 (one dose of monovalent vaccine followed by two doses of pentavalent vaccine),~     Group 4 (one dose of pentavalent vaccine followed by two doses of monovalent vaccine), Group~     5 (two doses of pentavalent vaccine followed by a dose of monovalent vaccine), Group 6 (one~     dose of pentavalent vaccine followed by a dose of monovalent vaccine and a dose of~     pentavalent vaccine), and Group 7 (a dose of monovalent vaccine followed by a dose of~     pentavalent vaccine and a dose of monovalent vaccine) in children from Mexico City.~      Secondary objectives~        -  To describe number and features of acute diarrheal disease (ADD) due to rotavirus~          displayed in the seven prevention schedules.~        -  To describe the adverse events temporarily associated with the seven prevention~          schedules.~      Hypotheses The seroconversion percentages and geometric mean titers (GMT) of anti-rotavirus~     antibodies from Groups 3, 4, 5, 6 and 7 are not inferior to the seroconversion percentages~     and the GMTs induced in subjects that received the routine vaccination schedules with two~     doses of the monovalent vaccine and three doses of the pentavalent vaccine (Groups 1 and 2).~   "
104997|NCT02193048|"~     The purpose of this study is to prospectively evaluate a scoring system to predict a mild~     course of disease in patients newly diagnosed with Crohn's disease.~   "
104998|NCT02193035|"~     Microparticles are small cell fragments that can induce fat plaques, calcification and~     formation of thrombus. They can be released through multiple stimulations, but also the high~     flow of blood through partially obstructed aortic valves.~      In patients with severely obstructed aortic valves the investigators hypothesize that~     microparticles levels will be elevated and that they will go down after percutaneous~     treatment of the valves.~   "
104999|NCT02193022|"~     Hypothesis:~      Primary hypothesis:~        1. Oral treatment with Miltefosine in children with PKDL at allometric daily dose (based on~          body weight and height) for 12 weeks is safe with a cure rate of ≥95%.~           Secondary hypothesis:~        2. Development of PKDL in children and adolescent is genetically predisposed and is~          associated with IL-10 & IFN-gamma gene polymorphism causing high and low serum level of~          IL-10 and IFN-gamma respectively.~        3. Nutritional & environmental factors such as low serum vitamin E, A, D, Zn & arsenic~          exposure are associated with PKDL.~   "
105000|NCT02193009|"~     The primary aim of this pragmatic randomized-controlled trial was to determine the~     effectiveness of a scalable 6-month intervention aimed at decreasing SSB consumption~     (SIPsmartER) when compared to a matched contact physical activity promotion control group~     (MoveMore).~   "
105001|NCT02192996|"~     This pilot trial is designed to investigate the benefits of the use of probiotics in GUT~     microbiota development and/or immunological biomarkers and how this can be related with the~     clinical status of very low birth weight preterms during their first weeks of life at the~     neonatal intensive care unit(NICU).~   "
105002|NCT02192983|"~     This study is designed to assess what is the better neoadjuvant chemotherapy regimen for~     patients with initially unresectable locally advanced gastric cancer.~   "
105003|NCT02192970|"~     The investigators hypothesize that bevacizumab instilled into the vitreous after primary~     retinal detachment surgery will reduce the formation of proliferative vitreoretinopathy and~     subsequent retinal re-detachment.~   "
105004|NCT02192957|"~     Atrial fibrillation is an abnormal heart rhythm in which the top chambers of the heart (the~     atrial chambers) beat very fast. Electrical cardioversion is a technique to convert heart~     rhythm from AF to normal rhythm. The technique sends out a brief electric shock to the heart~     through electrodes (paddles or skin patches) applied to the outside of the chest wall. The~     shock resets the heart rhythm back to its normal pattern.~      This technique is practiced at many hospitals, including the Heart Institute, and is not~     experimental. However no detailed national or international guidelines exist to assist~     physicians in performing cardioversion. Physicians use a variety of methods. Electrical~     cardioversion does not always restore normal rhythm. Adjusting the electrical energy dose,~     changing the electrode position and applying pressure to the electrodes may improve the~     success rate.~      This study will look at the safety and efficacy of a protocol (step by step method) for~     electrical cardioversion. The protocol prescribes the electrical energy dose, the electrode~     position and the application of pressure to the electrodes the physician will use. The~     individual elements of the protocol (energy dose, electrode position and pressure~     application) are often used by physician in clinical practice but not necessarily in the step~     by step order.~      The purpose of this study is to get all doctors to follow a standard protocol 'the Ottawa AF~     cardioversion protocol'. We think that using this protocol will improve overall cardioversion~     success rates. The results of this study may change usual practice in Canada and in other~     countries.~      All supplies, equipment and medications used in the protocol cardioversion are approved by~     Health Canada.~      We estimate that 389 participants from the University of Ottawa Heart Institute will be~     enrolled in the study over the next 2 years. The results will be compared with a group of~     previous patients.~   "
105005|NCT02192944|"~     Chloroquine and piperaquine are the two most widely used antimalarial drugs ever. Hundreds of~     millions of people have received these drugs. Both are structurally similar and have~     cardiovascular effect. While there are no concerns over the use of chloroquine, regulatory~     authorities have suggested restrictions on the use of piperaquine.~      We have recently completed a series of cross-over clinical and pharmacokinetic evaluations of~     chloroquine, piperaquine, pyronaridine and primaquine in healthy subjects. These studied were~     approved by the ethical committee of FTM. All drugs were well tolerated with no clinically~     significant ECG changes. Four subjects were in two studies. This offers a unique opportunity~     to compare the electrocardiographic effects of chloroquine and piperaquine in the same~     subjects and therefore characterize the concentration-effect relationships, and thus relative~     safety.~      We propose to extend the previous subject study to recruit 16 subjects including those who~     have received either piperaquine or chloroquine in our previous studies so that 20 subjects~     received both drugs for a crossover comparison. The blood sampling schedule and~     electrocardiograms would be exactly the same as previously but would finish at 24 hours.~   "
105014|NCT02192827|"~     The purpose of this study is to compare the efficacy of a single dose of dexamethasone vs.~     two doses of dexamethasone in mild and moderate asthma exacerbations pediatric patients.~   "
105015|NCT02192814|"~     EP0024 is a Phase 3, multicenter, open-label study to evaluate the safety and tolerability of~     intravenous (iv) lacosamide (LCM). Adjunctive iv LCM therapy (200 mg/day to 400 mg/day) will~     be administered for 5 days as replacement for oral LCM tablets in Japanese adults with~     partial-onset seizures.~   "
105052|NCT02192320|"~     To evaluate Efficacy and Safety of oral Atorvastatin and Dexamethasone on conservative~     treatment for Chronic Subdural Hematoma (CSDH) patients with Coagulation Disorders~   "
105053|NCT02192307|"~     This study will compare the safety and effectiveness of two water-based potassium oxalate~     desensitizers on existing dentinal hypersensitivity.~   "
105006|NCT02192931|"~     Methamphetamine (MA) addiction is a public health concern that causes substantial harm to~     individual users, and imposes an economic burden in the U.S. totaling up to $48.3 billion~     annually. This study proposes to address a critical aspect of this problem: the lack of any~     proven, FDA-approved pharmacological treatments for MA users. The proposal combines an~     intervention designed to improve energy metabolism in the brain, and a neuroimaging technique~     capable of measuring the neurochemicals that represent cerebral bioenergetic function. The~     study will replicate and extend a key neuroimaging finding from the investigators recent MA~     studies: that MA users have decreased phosphocreatine (PCr) levels in the brain, compared to~     healthy volunteers. Phosphocreatine is the substrate reservoir for the creatine kinase~     reaction, which reversibly converts PCr into adenosine triphosphate (ATP), the brain's major~     energy supply, and creatine. Neuronal energy demands are met through a shift in reaction~     equilibrium, which is designed to maintain the concentration of ATP constant. Research~     results from the investigators recent study also showed that female MA users have lower brain~     PCr levels compared to male users. These findings join the converging lines of evidence that~     MA use is associated with mitochondrial dysfunction, i.e. deficient energy metabolism, in the~     brain. Frequently, MA users also experience depression, as well as cognitive deficits.~     Interestingly, both of these entities are also linked to mitochondrial dysfunction in the~     brain.~      The long-term goal of this research program is to define the alterations in brain chemistry~     that underlie MA use disorders, and to utilize translational magnetic resonance spectroscopy~     (MRS) neuroimaging to identify rational brain-based treatment targets. Once a~     hypothesis-driven intervention is identified, MRS can then be further employed in treatment~     studies, to verify that target engagement is achieved. The specific aims of this proposal~     are an example of this stepwise scientific process: the nutritional supplement creatine will~     be tested in a randomized, placebo-controlled study of women with MA use disorders, to~     investigate creatine's effect on cerebral PCr levels, depressive symptoms, and MA usage.~   "
105007|NCT02192918|"~     The goal of this research is to develop and test the feasibility of an intervention that~     stimulates uptake of healthy alternatives to tanning by providing free access to them for a~     limited time. Free access gives participants a low-risk opportunity to try something new that~     is consistent with their motivations. Free access also allows them to experience the~     reinforcing properties of the alternatives which could prime continued use after the free~     trial period. The objective of the present study is to determine the feasibility and~     short-term efficacy of providing free alternatives to indoor tanners in an effort to nudge~     them to switch from indoor tanning to healthy alternatives.~   "
105008|NCT02192905|"~     The purpose of this research was to develop and test the feasibility of Habit, a weight loss~     mobile application that was designed to coach patients through their weight loss challenges.~     In a pilot trial in 43 obese participants, investigators tested the feasibility of the Smart~     Coach mobile application when paired with a shortened online-delivered (8-week) behavioral~     weight loss intervention. Feasibility outcomes included frequency and duration of usage of~     the mobile app and each feature, recruitment, and retention. Post-intervention focus groups~     discussed the feasibility and acceptability of the intervention. The investigators also~     performed exploratory analyses comparing conditions on problem solving skills and weight loss~     at 8 and 16 weeks, which will inform a subsequent randomized controlled efficacy trial.~   "
105009|NCT02192892|"~     Addition of α-amylase is considered as one of most effective solution to improve energy~     density of cereal based porridges (WHO, 2008). By adding α-amylase, the viscosity of~     porridges will be decreased while keeping dry matter content constant. Potential positive~     impact is to significantly improve efficiency of WFP nutritional programmes targeting~     vulnerable groups suffering from acute malnutrition.~      The acceptance of porridges made with α-amylase is tested compared to porridges made without~     α-amylase among 12-36 months old children and their caregivers. Acceptance is measured based~     on energy intake. The porridges tested consist of fortified blended Supercereal (12- <24~     months) and Supercereal-Plus (24-36 months) based on Corn Soy Blend (CSB) extruded or drum~     dried, Wheat Soy Blend (WSB), Rice Soy Blend (RSB), all with and without α-amylase, or a~     commercial porridge, or eeZee bar.~   "
105010|NCT02192879|"~     This study aims to compare the efficacy and safety of three alternative methods of analgesia~     in patients undergoing complex liver resection surgery: 1) thoracic epidural analgesia (TEA),~     2) continuous paravertebral block (PVB) with patient-controlled analgesia (PCA) and 3)~     patient-controlled analgesia (PCA) alone. Regional anesthesia techniques such as TEA and PVB~     may improve recovery and decrease postoperative pain scores in addition to other benefits~     such earlier return of bowel function and shortened length of hospital stay, although some~     practitioners have voiced concerns about the safety and efficacy of these techniques in~     patients after liver resection who may develop postoperative coagulation abnormalities. The~     investigators plan to enroll a total of 150 patients (adults >/= 18 years of age who meet~     study criteria) scheduled for complex liver resection surgery in this study, who will then be~     randomized into 50 patients per arm of the study (3 total arms). Postoperative pain scores~     will be collected in PACU and throughout the patient's hospital stay as well as routine blood~     tests including complete blood count, coagulation labs (PT/INR, aPTT) and serum creatinine to~     measure renal function. The study team will also collect additional data prospectively on all~     patients enrolled in the study; these parameters will include age, sex, type of operation~     performed, length of operation, volume of intraoperative blood loss, volume of intraoperative~     fluid administration including blood products, daily postoperative intravenous fluid~     administration, length of time to first feeding, day of epidural catheter removal, length of~     hospital stay and incidence of major postoperative complications (surgical, respiratory,~     cardiac, renal, etc.). Once primary and secondary data points are obtained, the data will~     undergo rigorous statistical analysis using the appropriate statistical techniques to~     determine the outcomes. The investigators propose that epidural and/or paravertebral~     analgesia may improve recovery times and decrease hospital length of stay, which would be~     beneficial for the patient as well as decrease hospital costs. In addition, if better~     postoperative pain management scores can be achieved with epidural or paravertebral~     analgesia, and no significant prolonged postoperative coagulopathy is associated with~     patients undergoing major hepatic resection surgical procedures, these regional analgesia~     strategies can be considered a safe option for pain management in this patient population.~   "
105011|NCT02192866|"~     Food allergies are now a major problem. These experiments involve getting blood from people~     with food allergies and from people without food allergies. The blood collected will be used~     to answer questions and find information about peanut and other food allergies.~      Samples will come from:~        -  People signed up by the investigators at the University of Colorado Denver~        -  University of North Carolina and Massachusetts General Hospital where people have been~          treated for peanut allergies~        -  University of North Carolina, Massachusetts General Hospital, National Jewish Health and~          The Children's Hospital in Denver where people have taken part or will take part in~          clinically indicated oral food challenges.~      Blood and health histories from the University of North Carolina, Massachusetts General~     Hospital, National Jewish Health, and The Children's Hospital will not have personal~     information linked.~      The specific aims of this experiment are:~        1. Come up with a lab test that will predict how bad an allergic reaction will be to~          peanuts.~        2. Find out what part of a peanut causes allergic reactions.~        3. Come up with preventions that can block peanut allergies.~        4. Find the strongest proteins in walnuts.~   "
105012|NCT02192853|"~     The investigators want to estimate both the endothelial and the plasma activity of dipeptidyl~     peptidase 4 during different doses of sitagliptin in healthy subjects and patients with type~     2 diabetes. Furthermore, the investigators want to investigate whether the current clinical~     dose of 100 mg of sitagliptin is sufficient to inhibit both the plasma and the endothelial~     activity of the enzyme dipeptidyl peptidase 4.~   "
105017|NCT02192788|"~     This study aims to probe the effect of SBRT as a treatment oligometastases of prostate~     cancer, regardless of basal treatment received, and I know the response, biochemical control,~     the progression-free survival as well as their impact on quality of life.~      Primary Objective: Local and symptomatic oligometastases Control of prostate cancer treated~     by SBRT.~      Secondary Objectives: Analyzing biochemical progression rates, progression-free survival,~     chemotherapy-free survival and overall survival. Analyze toxicities and quality of life of~     patients before and after treatment~   "
105018|NCT02192775|"~     The purpose of this study is to determine the clinical efficacy of MV-NIS (measles~     virus-sodium iodide symporter) therapy for people with relapsed/refractory myeloma when given~     with cyclophosphamide~   "
105019|NCT02192762|"~     This is a pilot study of a withdrawal regulation training program compared to relaxation~     training for individuals that are interested in smoking cessation.~   "
105020|NCT02192749|"~     Allogeneic (not from the subject) human umbilical cord tissue-derived stem cells administered~     intravenously (IV) in a series of 4 infusions every 3 months over the course of one year is~     safe and will induce a therapeutic effect in autism patients.~   "
105021|NCT02192736|"~     Allogeneic mesenchymal trophic factors (MTF) from human umbilical cord tissue-derived~     mesenchymal stem cells (UC-MSC) administered intra-nasally to 20 patients is a safe and~     useful procedure for inducing improvements in pulmonary function and quality of life in~     patients with asthma.~   "
105022|NCT02192723|"~     The purpose of this study is to compare the efficacy and side effects of 6 commonly used~     antipsychotic drugs in the treatment of schizophrenia in a Chinese population.~   "
105023|NCT02192710|"~     Rationale:~      The most frequently used means to prevent pre-anaesthetic anxiety in children is a drug~     premedication. Midazolam, a benzodiazepine, is mainly used. It requires time for action, so~     coordination between departments and operating room, exposed to the risks of side effects and~     failure and this variability action. Alternative means were evaluated, such as the presence~     of parents during anaesthetic mask induction, distraction by clowns, hypnosis or video games.~      Electronic tabs are small devices; light, easy to use with age-specific and interactive~     programs. Our hypothesis is that these electronic tabs are more effective in reducing anxiety~     and distract children compare to preoperative medication.~      Methods: This is a monocentric, randomized, open-label study comparing patients aged 4 to 10~     years old programmed for a short term and low level of pain outpatient surgery. My pass score~     will be measured when arriving at the hospital, at the time of the separation with the~     parents, at the time of the anaesthetic mask induction and after the surgery.~      118 patients will be randomized as follows :~        -  Arm 1 : Hypnovel® (midazolam)~        -  Arm 2 : Electronic tab The recruitment is performed by general practitioners in the Lyon~          area.~   "
105024|NCT02192697|"~     Purpose of the study is to determine the following in patients with non-small cell lung~     cancer (NSCLC) harboring EGFR activating mutations.~        -  the safety and tolerability of ASP8273.~        -  the pharmacokinetics (PK) of ASP8273.~        -  the antitumor activity of ASP8273.~   "
105025|NCT02192684|"~     Obstructive sleep apnea (OSA) and type 2 diabetes confer increasing economic, social, and~     public health burdens in the United States. That these diseases appear to co-exist and~     together increase one's risk of cardiovascular disease renders investigation into their~     shared pathophysiology even more urgent. Investigators will assess prevalence of insulin~     resistance, a precursor to diabetes, among overweight patients with OSA. Among those at~     highest risk of diabetes, investigators will randomize participants to pioglitazone or~     placebo to see the efficacy of the intervention on improving OSA, insulin resistance, and/or~     insulin secretion. In a separate intervention, investigators will evaluate the~     cardiometabolic benefits of continuous positive airway pressure (CPAP) for 12 weeks in~     patients with OSA. Investigators will also study subjects from the community without known~     sleep apnea, and assess whether insulin-resistant individuals are at risk for sleep apnea~     using clinical screening questionnaires.~   "
105026|NCT02192671|"~     The purpose of the investigators' study is to prospectively compare the safety and efficacy~     of hepatic resection to radiofrequency ablation for hepatocellular carcinoma in patients with~     portal hypertension.~   "
105027|NCT02192658|"~     According to the recent World Report on Disability, around 15% of the world population lives~     with a disability and 80% of people with disabilities (PWD) live in developing countries.~     More and more evidence show that PWD are more likely to be poor, vulnerable to physical and~     sexual violence, and to have less access to education. Therefore, PWD are likely to have an~     increased risk for HIV infection, potentially being a key population in regard to this~     epidemic.~      The vulnerability of PWD was recognized in 2007 by the United Nations Convention on the~     Rights of Persons with Disabilities. However, data on the extent how PWD are affected by HIV~     is still very limited. As a result, PWD are usually overlooked by National AIDS Control~     Programmes and few projects specifically targeting them have been developed.~      Recognizing the need for appropriate and reliable data to help protect the rights of PWD and~     achieve a better inclusion of disability in National AIDS Control Programmes, the Institute~     of Research for Development (IRD), the Institut de Formation et Recherche Demographique~     (IFORD) and Handicap International (HI) propose this study that aims to provide quantitative~     and qualitative data on the vulnerability of PWD to HIV infection in Cameroon and Burkina~     Faso, in order to define if this vulnerable population is also a Key Population in relation~     to the HIV epidemic. This study adopts a multidisciplinary approach (quantitative and~     qualitative methods). Quantitative data are collected only in Cameroon.~      Only the quantitative study is described here.~   "
105028|NCT02192645|"~     The purpose of this study is to determine whether Sanfujiu is effective and safe in the~     treatment of persistent allergic rhinitis.~   "
105029|NCT02192632|"~     The purpose of this study is to evaluate the efficacy and tolerability of this combination~     gel compared with BPO monotherapy in Korean patients, and test clinical practicability of~     dermatologists' educational demonstration for how to apply this gel in reducing uncomfortable~     irritations.~   "
105030|NCT02192619|"~     The registry aims to document epidemiologic data, treatment and long-term outcome as well as~     quality of life of patients with APL. Additionally, a biobanking project for further~     translational studies is integrated.~      Prospective population-based non-interventional and non-randomized multicenter registry.~   "
105031|NCT02192606|"~     The objective aim is to evaluate whether the use of 3D laparoscopy facilitates the vaginal~     cuff closure of the vaginal cuff during a total laparoscopic hysterectomy among novice~     laparoscopists (PGY 2-4, Fellow). This is a randomized single blinded controlled trial~     comparing the difference in 2D vs. 3D in regards to vaginal cuff closure time stratified by~     residents and fellows. Patients will undergo a total laparoscopic hysterectomy and will be~     randomized to either 2D versus 3D.~   "
105032|NCT02192593|"~     This is a randomized controlled trial, examining the effects of a computerized,~     internet-based Cognitive Behavioral Therapy (CBT) Intervention for persons with a~     schizophrenia spectrum disorder who experience distressing auditory hallucinations (voices).~     Participants are randomized to one of two conditions: either to receive the 10-session~     computer-based program on a weekly basis, or to their usual care at their mental health~     clinic. This study takes place at Cambridge Health Alliance in Cambridge Massachusetts. It is~     hypothesized that the participants who participate in the CBT program will have significant~     improvements in the severity of their auditory hallucinations, as well as their associated~     distress, compared to the participants receiving usual care.~   "
105033|NCT02192580|"~     Urinary tract infections (UTI) are a common and important clinical problem in childhood.Upper~     urinary tract infections (ie, acute pyelonephritis) may lead to renal scarring, hypertension,~     and end-stage renal disease.Pathogenesis of acute pyelonephritis (APN) is associated with~     urinary tract anatomy and function, bacterial virulence factors, the host innate immune~     system and production of free radicals. Oxygen-free radicals and oxidative stress play a role~     in renal scar formation after an APN. Oxygen-free radical scavengers and antioxidants can~     reduce tissue damage and renal scaring during acute pyelonephritis.we want to publish a study~     that indicates that antioxidant therapy with omega-3 given to children with pyelonephritis~     may indeed lower the risk for renal scarring.~      Several studies show that omega-3 alleviated oxidative stress and inflammation.This study is~     a simple randomized clinical trial (RCT) evaluating the effect of omega-3 in addition to~     antibiotic on preventing renal scaring after acute pyelonephritis in children. This~     randomized clinical trial on 60 patients in 2 groups (intervention & control) is~     conducted.Children aged 1 month to 10 years with positive urine culture, clinical findings,~     and 99mTc-dimercaptosuccinic acid (DMSA) scintigraphy-based evidence in favor of acute~     pyelonephritis were enrolled into a clinical trial. Patients with neurogenic bladder,~     systemic hypertension, obstructive uropathy and high grade vesicouretera are~     excluded.Patients in Intervention group are administered omega-3 based on body weight in~     divided doses in addition to antibiotic regimens and patients in control group received~     antibiotic regimens without omega-3. Primary outcome is the development of renal scar by~     doing DMSA renal scan on the 7th day of admission and four to six months after the~     intervention and compared between groups.Also,measurement of urinary biomarker of acute~     kidney injury (NGAL) three days after antibiotic or omega-3 administration for assessing of~     subsequent scarring in both groups will be done . Secondary outcome is the incidence and~     severity of renal scarring after pyelonephritis and response to treatment between two groups.~   "
105034|NCT02192567|"~     This is an open-label, sequential dose escalation and expansion study to evaluate the safety,~     and pharmacokinetics of DS-5573a in Japanese patients with advanced solid malignant tumors.~   "
105035|NCT02192554|"~     To follow-up on the safety of subjects who were previously treated in a double-blind trial of~     brexpiprazole.~   "
105036|NCT02192541|"~     Background:~      - Some people have cancers that don't respond to standard treatments. In these cases, doctors~     may try to use drugs to slow the growth of the cancer.~      Objectives:~      - To test the safety and efficacy of the drug combination of ganetespib and ziv-aflibercept.~      Eligibility:~      - Adults age 18 and over with advanced cancer of the colon, lung, urinary tract, and~     sarcomas.~      Design:~        -  Participants will be screened with medical history, blood tests, and scans to measure~          their tumors.~        -  Participants will have one or two eye exams, with dilating eye drops.~        -  Participants will get the study drugs at the clinic as an infusion in a vein. Ganetespib~          will be given once a week on the same day for 3 weeks in a row, followed by a 1-week~          rest period. Ziv-aflibercept will be given once every other week. The drugs will be~          given in 28-day cycles.~        -  Participants may have a small piece of their tumor collected once or twice. This is done~          using a small needle during computed tomography (CT), magnetic resonance imaging (MRI),~          or ultrasound scan.~        -  Participants will have their blood pressure checked at each visit. They will check it at~          home every day of the study.~        -  Participants may have one or more whole-body positron emission tomography (PET) scans~          with 89Zr-panitumumab. A small amount of a radioactive chemical will be injected through~          a tube in an arm. Participants will lie on a bed that slides in and out of the~          donut-shaped PET scanner. They will have small amounts of blood drawn.~        -  Participants may stay in the study as long as they are tolerating the drugs and their~          tumor is not getting worse.~   "
105037|NCT02192528|"~     We will use a retrospective data analysis to evaluate the association of the two vitamin D~     metabolites 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D with clinical outcome in cardiac~     surgical patients. The occurrence of several postoperative adverse events such as myocardial~     infarction, low cardiac output syndrome, stroke and in-hospital death will be assessed from~     cardiac surgery to discharge. In addition, we will assess the association of the two vitamin~     D metaboolites with the duration of mechanical ventilatory support and intensive care unit~     stay from cardiac surgery to discharge. Moreover, in-hospital stay will be assessed according~     to vitamin D metabolite levels.~   "
105038|NCT02192515|"~     The purpose of this study is to assess the safety and pharmacokinetics of APD356 in healthy~     Japanese adult subjects. Regarding cohorts 1 to 3, this study is a single center,~     placebo-controlled, randomized,double-blind study. Regarding cohort 4, this study is a single~     center, randomized, open-label study that consists of two sequential two-way crossover~     studies. The study consists of 4 cohorts. In cohort 1, subjects will be randomized to 10 mg~     group (6 subjects) or placebo group (2 subjects) to receive single dose of study drug. In~     cohort 2, subjects will be randomized to 20 mg group (6 subjects) or placebo group (2~     subjects) to receive single dose of study drug. In cohort 3, subjects will be randomized to~     XR-20 mg group (6 subjects) or placebo group (2 subjects) to receive single dose of study~     drug on Day 1 and multiple doses of study drug on Day 8-14 once daily before breakfast. In~     cohort 4, subjects will be randomized to Sequence A (8 subjects) or Sequence B (8 subjects)~     to receive study drug in the sequence shown below.~      Sequence A: 10 mg tablet, 2 doses (12 hours apart) => XR-20 mg orange tablet, single dose =>~     XR-20 mg orange tablet, q. d., multiple doses (fasted) => XR-20 mg orange tablet, q. d.,~     multiple dose (fed)~      Sequence B: XR-20 mg orange tablet, single dose => 10 mg tablet, 2 doses (12 hours apart) =>~     XR-20 mg orange tablet, q. d., multiple dose (fed) => XR-20 mg orange tablet, q. d., multiple~     doses (fasted)~   "
105054|NCT02192294|"~     This is an open-label, randomized, single-dose, one-cohort, two-sequence, two-period~     crossover study in healthy subjects.~   "
105055|NCT02192281|"~     The purpose of this study is to determine whether Playworks has an impact on student and~     school outcomes such as physical activity, behavior, and academic performance.~   "
105039|NCT02192502|"~     The purpose of this study is to evaluate the safety of a standard volume replacement called~     HES 130/0.4 (Voluven) during surgery on recovery. HES 130/0.4 (Voluven) may offer an~     alternative to pure fluid replacement solutions that are associated with problems after~     surgery including fluid overload and respiratory difficulties. The safety of HES 130/0.4~     (Voluven) will be evaluated by examining its effects on kidney function, and coagulation~     parameters and platelet (part of the blood that help it clot) function.~      Participants will be randomized (like flipping a coin) to receive one of two possible volume~     replacements during surgery, if fluid volume decreases enough to need replacement with one of~     the fluids. The two possible volume replacements are Voluven (a starch-containing fluid) or~     human albumin 5% (a protein-containing solution).~      To examine kidney function, urine will be-sampled when the participant is put under general~     anesthesia, before surgical incision, within one hour of arrival to the ICU and 24 hours~     after completion of surgery. Two tubes (2 teaspoons) of blood (from an already established~     line) will be taken the morning of the surgery, within one hour of arrival to the ICU, 24~     hours after surgery and every morning during the participants postoperative ICU stay.~      Additionally, health and recovery information will be recorded from the participant's medical~     record. We will phone participants around 90 days and one year after surgery to ask a few~     questions about one's health and recovery. We will also record blood sample analysis results~     from follow up appointments within the first year after surgery. If this analysis is not~     conducted at the Cleveland Clinic, with permission, we will obtain the results from a~     treating physician.~   "
105040|NCT02192489|"~     This study will evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy~     of oral CC-220 in adult subjects with chronic cutaneous sarcoidosis.~   "
105041|NCT02192476|"~     california tri-pull taping (CTPT) method might be effective in reducing shoulder subluxation,~     pain, and improving active flexion range (AFLXN) range of motion, and functional recovery~     after stroke.~   "
105042|NCT02192463|"~     Study to determine the relative bioavailability of different oral Viramune Extended Release~     (ER) formulations compared to Viramune® Immediate Release (IR) tablet~   "
105043|NCT02192450|"~     The purpose of this study is to determine whether insulin degludec compared to insulin~     glargine can reduce the risk of symptomatic nocturnal hypoglycaemia in subjects with the~     greatest potential benefit from optimised insulin treatment, which are patients with type 1~     diabetes and high risk of nocturnal severe hypoglycaemia.~   "
105044|NCT02192437|"~     Studies in laboratory models indicate that dietary methionine restriction (MR) enhances~     longevity and produces short- and long-term metabolic changes that are consistent with a~     healthy lifespan. The present study was designed to establish levels of dietary methionine or~     methionine and cysteine that induce physiological changes in healthy adults like those~     observed in rodent studies .~   "
105045|NCT02192424|"~     Type 2 diabetes mellitus is a chronic metabolic disorder characterized by progressive~     deterioration in the function of the pancreatic beta-cells, which are the cells that produce~     and secrete insulin (the hormone primarily responsible for the handling of glucose in the~     body). The investigators propose a randomized controlled trial to determine whether~     intermittent intensive insulin therapy is an effective therapeutic strategy that can preserve~     pancreatic beta-cell function and maintain glycemic control early in the course of type 2~     diabetes.~   "
105046|NCT02192411|"~     Endovenous laser treatment is a minimally invasive procedure that has been shown to be a safe~     and effective treatment for varicose veins. Essential to the successful ablation of refluxing~     veins by endovenous laser treatment is the use of tumescent anesthesia. One of the components~     of tumescent anesthesia is lidocaine, a commonly used local anesthetic. While lidocaine can~     be used safely as long as serum concentrations remain low, its use carries the risk of~     lidocaine toxicity. In order to minimize the risk of lidocaine toxicity it is desirable to~     use the minimum effective concentration of lidocaine needed to manage pain during a~     procedure. This study seeks to determine if a ¼ lower concentration of lidocaine in tumescent~     anesthesia will function as well as the standard dose for pain management in endovenous laser~     treatments. If we find that this is the case, we will be able to reduce the risk of lidocaine~     toxicity in patients undergoing endovenous laser treatment, while maintaining their comfort~     throughout the procedure. This will be achieved through a direct comparison of intra- and~     post-operative pain for patients randomized to receive either the ¼ tumescent lidocaine~     concentration or the standard lidocaine concentration.~   "
105047|NCT02192398|"~     Combination of guanfacine with opioid medication as a standard treatment for chronic pain.~   "
105048|NCT02192372|"~     Prevention of contrast induced nephropathy after interventional cardiologic procedures~     deserves close interest because of its association with prolonged hospitalization, increased~     cost and increased in hospital and long term mortality rates. An observational prospective~     cohort study was designed to determine whether metabolic syndrome predicts the development of~     contrast induced nephropathy after elective percutaneous coronary intervention.~   "
105049|NCT02192359|"~     This phase I trial studies the side effects and best dose of carboxylesterase-expressing~     allogeneic neural stem cells when given together with irinotecan hydrochloride in treating~     patients with high-grade gliomas that have come back. Placing genetically modified neural~     stem cells into brain tumor cells may make the tumor more sensitive to irinotecan~     hydrochloride. Irinotecan hydrochloride may stop the growth of tumor cells by blocking some~     of the enzymes needed for cell growth. Giving carboxylesterase-expressing allogeneic neural~     stem cells and irinotecan hydrochloride may be a better treatment for high-grade gliomas.~   "
105050|NCT02192346|"~     The goal of this study is to find the highest dose of α-TEA that can be given to patients~     safely, to identify potential side effects of α-TEA, and to measure the amount of α-TEA in~     patients' blood.~      Additional goals of this study are to monitor the effect on tumors, to check for specific~     immune cells circulating in the blood, and to see if there are certain features of tumors~     that make it possible to predict the response to α-TEA.~   "
105051|NCT02192333|"~     This randomized clinical trial studies survivorship care in reducing symptoms in young adult~     cancer survivors. Survivorship care programs that identify the needs of young adult cancer~     survivors and ways to support them through the years after treatment may help reduce~     symptoms, such as pain, fatigue, sleep disturbance, depression, and distress, in young adult~     cancer survivors.~   "
105056|NCT02192268|"~     The hypothesis of this study is that the physiologic effects of these (PEP/ HFOO) resources~     may have positive effects in this population of children with acute respiratory illness.~      Thinking about this physical and physiological issue and due to the absence of a study that~     has evaluated the effectiveness of these instruments in patients with pneumonia, the~     objective of this study is to evaluate the short-term effects OOAF and mask of EPAP in~     children hospitalized for community-acquired pneumonia.~   "
105057|NCT02192255|"~     This multisite pragmatic clinical trial was designed to assess the effectiveness of a single~     scripted telephone call to diabetes patients who (a) were currently above recommended~     clinical goals for glucose, blood pressure, or lipids, and (b) had recently been prescribed a~     new medication for that specific clinical domain. The goals of the intervention were to~     improve primary adherence and persistence to the newly prescribed medication and to improve~     control of glucose, blood pressure, and lipids.~   "
105058|NCT02192242|"~     The pathophysiology of acute ischemic pain is not well established. The aim of the present~     study was to investigate acute ischemic pain in humans with a view to establish a scientific~     model to perform future studies. The investigators examined whether peripheral nerve damage~     and acute inflammation occur during short episodes of acute ischemia.~   "
105059|NCT02192229|"~     Abstract:~      The main objective of the proposed study is to examine the Safety and Efficacy Evaluation of~     the Dose Regimen of Vitamin D 50,000 IU (Biodal) tablet supplementation in the treatment of~     population with vitamin D deficiency.~      A randomized, double-blind placebo, Parallel design comparing vitamin D with Placebo will be~     conducted on 60 Healthy males and females with vitamin D deficiency, age from 18 to 49 years~     who attend the rehabilitation clinics at Jordan University Hospital .Participants who met the~     inclusion criteria will be asked to sign an informed witnessed consent form. Results obtained~     are expected to assess the safety and efficacy of the dose regimen used in this study as per~     Biodal SmPC. This study will also contribute to the global body of knowledge in this field.~     The major findings generated from this study could open certain avenues for further research~     through the association of the status of vitamin D in serum .~   "
105060|NCT02192216|"~     Chemotherapy can induce muscle loss in colorectal, breast and advanced renal cell carcinoma~     patients. The Danish nation-wide training and rehabilitation offer 'Body & Cancer' offers~     intensive resistance and endurance training to all Danish cancer patients receiving~     chemotherapy with the aim of reducing treatment-related fatigue and physical impairments, but~     the potential of the training to preserve or improve muscle mass is uninvestigated.~      Furthermore, the underlying biological mechanisms of treatment and/or exercise induced~     changes in muscle mass in cancer patients remains uninvestigated.~      Thus, the primary purpose of the present study is to investigate changes in body composition~     during chemotherapy and after resistance and aerobic training combined with protein~     supplementation during ongoing chemotherapy in cancer patients. Secondly, we aim to~     investigate the underlying biological mechanisms of muscle mass regulation in biopsies~     obtained before and after a control period as well as after 10 weeks of exercise, both during~     chemotherapy.~      We hypothesize that 10 weeks exercise will improve muscle mass and body composition in cancer~     patients during chemotherapy as compared to a control period during chemotherapy alone.~   "
105061|NCT02192203|"~     This research study is being carried out to determine the possibility that a new medication~     causes allergic reactions. This new medication contains two active ingredients (diclofenac~     and menthol) together in a gel and is being developed to treat mild to moderate pain and~     inflammation, such as acute sport injuries, and sprains and strains. Approximately 240~     participants will have the medication (gel) applied to the skin on a small area of the upper~     back for approximately 48-hour or 72-hour periods over the course of six weeks. Participation~     in this research study is voluntary, requiring participants to visit the study clinic on 17~     occasions for about 45 minutes each visit. During the visits, doctors or trained staff~     members will examine the amount of redness, swelling, and other signs of irritation (if any)~     of the skin where the medication (gel) was applied.~   "
105062|NCT02192190|"~     The main purpose of this study is to test if LY2951742 relieves mild to moderate knee pain.~     The study drugs will be given as an injection under the skin and as an oral capsule. The~     study will last about 28 weeks for each participant.~   "
105063|NCT02192177|"~     Intrahepatic cholestasis of pregnancy is a disease specific to pregnancy period; especially~     late second and third trimester. We aimed to investigate the role of apoptosis in~     etiopathogenesis of obstetric cholestasis.~   "
105064|NCT02192164|"~     Pilot observational study to describe the relationship between the smoking status of a~     psoriatic individual and the success of etanercept therapy in psoriasis treatment~   "
105065|NCT02192151|"~     To evaluate the safety and to investigate the pharmacokinetic properties and bioavailability~     of PHN131 in healthy volunteers~   "
105066|NCT02192138|"~     Research project objectives.~      The project includes eight research hypotheses and eight corresponding study objectives. The~     most relevant objectives are:~        -  Analysis of lung function and gas exchange parameters in relation to the removed pleural~          fluid volume and intrapleural pressure changes.~        -  Evaluation of changes in lung and chest wall compliance and related changes in work of~          breathing during therapeutic thoracentesis and pleural fluid withdrawal.~        -  Study of the relationship between intrapleural pressure changes and cardiac function~          assessed by echocardiography and alterations in serum natriuretic peptide A and B~          concentration.~        -  Comparative analysis of the reliability of the volume-pressure curve slope prediction~          based on different variables measured before thoracentesis and real measurements of~          ventilation and intrapleural pressure during thoracentesis.~           2. Research methodology The study will be performed in 60 patients with pleural effusion~          planned for therapeutic thoracentesis.~      Studies before thoracentesis: body plethysmography, spirometry, lung diffusion capacity~     (DLCO), arterial blood gases, 6 minute walk test, echocardiography, serum natriuretic peptide~     concentration.~      Evaluation during thoracentesis: continuous measurement of tidal breathing and respiratory~     rate, measurement of removed pleural fluid volume and intrapleural pressure, transcutaneous~     measurement of PO2 and PCO2. Pleural catheter will be retained for the next 48hours to enable~     fluid drainage and intrapleural pressure measurement after completion of thoracentesis.~      Monitoring during 48-hrs after thoracentesis: pre-thoracentesis measurements will be repeated~     in specific time points and compared in two subgroups (active physiotherapy to improve lung~     re-expansion and passive lung re-expansion).~      Intrapleural pressure will be measured 24 and 48 hours after thoracentesis. Then, the~     catheter will be removed.~      Analysis.Signal analysis and visual multidimensional analysis performed with the use of own~     computer programs will be the first step of the analysis. The identified relationships~     between the analyzed parameters should allow to form physiological, medical, and statistical~     hypotheses, as well to verify the analysis of previously obtained data .~      Expected impact of the research project The study results will allow to define lung function,~     blood gases and cardiovascular function in relation to changes in intrapleural pressure. Some~     of these correlations had not been previously investigated. Our results may influence~     management standards in patients who require therapeutic thoracentesis.~   "
105067|NCT02192125|"~     The study examines the possible application of the rehabilitation platform REWIRE.~   "
105092|NCT02191787|"~     Study to determine the antioxidant potency of Seresis® in the serum of healthy volunteers and~     the optimal time for blood sampling~   "
105068|NCT02192112|"~     Though the utility of NVM5 neuromonitoring by stimulating within the surgical site during~     XLIF has been demonstrated, it is hypothesized that more information may be gathered if a~     greater section of the motor neural pathway was monitored (i.e., stimulation above the~     surgical site and recording the subsequent muscle response in the lower limbs). Currently,~     there has not been demonstrated a practical method of stimulating the lumbosacral nerve roots~     locally, but well-above the surgical site in this fashion.~      This protocol is intended to evaluate the feasibility and reproducibility of using surface~     stimulation and return (anode) electrodes to stimulate the lumbosacral nerve roots, and~     record responses from the relevant innervated muscle groups of the lower limbs.~   "
105069|NCT02192099|"~     Examine the safety of long term repeat exposure to GLYX-13 in subjects who participated in~     GLYX13-C-202.~   "
105070|NCT02192086|"~     The goal of the proposed study is to evaluate the efficacy of a goal-directed fluid~     administration algorithm on early graft function in patients undergoing kidney~     transplantation. Fluid administration has increasingly been scrutinized within anesthesia~     related literature as an area for improvement, and the imbalance present between estimated~     blood loss and total fluid administered for kidney transplants must be amongst the highest~     case categories. Considering the patients are anuric for the majority of the procedure,~     unguided administration of multiple liters of crystalloid appears antiquated.~   "
105071|NCT02192073|"~     Biceps pathology typically includes pain in the anterior shoulder that is reproduced with~     provocative maneuvers. However, optimal treatment of patient with this diagnosis is not clear~     and can include tenotomy (cutting the biceps) or various forms of tenodesis (cutting then~     reattaching). As tenotomy can lead to cosmetic deformity and anterior humeral discomfort from~     spasms, many surgeons perform tenodesis. There are various techniques for tenodesis. This~     study will compare 2 methods: suprapectoral (doing the surgery using an incision higher in~     the shoulder) versus subpectoral fixation (surgery which involves making an incision lower in~     the shoulder).~      Purpose of the study is to prospectively determine whether arthroscopic suprapectoral or open~     subpectoral biceps tenodesis results in better function.~   "
105072|NCT02192060|"~     The aim of the study is to compare the effect of a suspension containing Triclosan in dynamic~     of the subgingival biofilm formation versus a Placebo suspension. The initial subgingival~     biofilm formation will be evaluated by means of Plaque Free Zone (PFZ).~   "
105073|NCT02192047|"~     The investigators hypothesized that there will be a significant difference between the~     effects of trans-free palm-, interesterified palm- and interesterified soybean oil blend on~     cardiovascular disease, inflammation, insulin resistance and obesity.~   "
105074|NCT02192034|"~     Colorectal cancer is the second leading cause of death from cancer in the United States. Two~     major barriers to successful colorectal cancer screening are appointment keeping and proper~     bowel preparation. The purpose of this study is to test the efficacy of a patient navigation~     program to increase colorectal cancer screening at Rush University Medical Center. The~     investigators hypothesize that colorectal cancer screening will be improved for subjects who~     utilize a patient navigator.~   "
105075|NCT02192021|"~     The study hypothesis is that in situ MNA-directed chemo-immunotherapy using doxorubicin will~     kill tumor cells locally and alter the tumor microenvironment to induce durable systemic~     tumor-specific immunity.~      The purpose of this study is to test a new method of experimental treatment for CTCL, using~     small adhesive-like patches (a micro-needle applicator or MNA for short), which have dozens~     of very small micro-needles loaded with extremely low doses of doxorubicin, a chemotherapy~     agent. The overall goal of this study is to test the safety and effectiveness of these~     patches. We also want to determine which micro-dose of the drug is the best to achieve the~     best response. To make sure that we observe the effects of the very low dose of the drug and~     not the MNA patch itself, we will also use a placebo (a patch without drug in some patients)~     in addition to the doxorubicin coated patches. We will thoroughly evaluate the skin where the~     patches are applied. Once the best dose is determined for use in the patch, we will also~     begin to look at how well the patches work in clearing the skin.~   "
105076|NCT02192008|"~     Enteric fever, an infection characterised by diarrhoea and rash, is most often caused by a~     bacteria called Salmonella enterica. After ingesting contaminated food or drink, the~     Salmonellae travel first to the gut, then the bloodstream, from where they can infect other~     parts of the body. Antibiotics are used to kill the bacteria, but with increasing rates of~     antibiotic resistance, this treatment is becoming less effective.~      Two Salmonella variants, Typhi and Paratyphi, cause over 30 million cases of enteric fever~     and more than 200,000 deaths per year, mostly in developing countries. While improved hygiene~     and sanitation should eventually eliminate enteric fever, reduction of the disease burden in~     the medium term is achievable through effective vaccination.~      Vaccines likely to be available for mass vaccination are effective only against those~     Salmonella strains that bear the Vi polysaccharide capsule protein. Strains that do not have~     these capsule proteins, or have no capsule, will not be affected by vaccination and could~     'fill' the space vacated by the capsulated strains. Indeed, enteric fever caused by S.~     Paratyphi A which does not carry the Vi protein, has risen during the past decade and~     accounts for more than half of all cases in some areas. Thus it is important that effective~     vaccines are available to protect against infection by both capsulated and noncapsulated~     Salmonella enterica. To develop such vaccines, we need a complete understanding of the human~     immune response to both types, including the contribution of immunity in the gut and the~     bloodstream, immune response to bacterial surface proteins, and the role of antibodies. How~     much cross-protection there is between the types of typhoidal Salmonellae after natural~     infection or vaccination is not known, but this is critical to vaccine development.~      This project aims to fill in the knowledge gaps highlighted, by fully characterising the~     infection process and immune response in enteric fever.~   "
105077|NCT02191995|"~     Yoga facilitates the treatment of eating disorders by decreasing symptom severity over time.~   "
105078|NCT02191982|"~     This study will look at the impact of a self-directed walking program on post-chemotherapy~     survivors experiencing fatigue. It is hypothesized that the walking program will help lessen~     fatigue.~   "
105079|NCT02191969|"~     This study will see if patient who undergo a physical activity intervention called Walk With~     Ease report experiencing less fatigue and a higher quality of life during chemotherapy for~     colorectal cancer than those who do not participate in this intervention.~   "
105080|NCT02191956|"~     This study aims to the test the efficacy and cost effectiveness of new service delivery~     methods to enhance the reach and impact of the standard of care treatment, Behavioral Parent~     Training (BPT), for early onset disruptive behavior disorders.~   "
105093|NCT02191774|"~     Medical abortion performed in the womens home has shown to be safe and acceptable up to 9~     weeks of gestation. Our project is aiming to confirm our hypothesis that it is equally~     effective, safe and acceptable when the gestation is more advanced, up to 10 weeks of~     gestation.~   "
105081|NCT02191943|"~     The aim of the planned in-vivo trial is to investigate the effectiveness of the caries~     infiltration technique for the repression of caries progression.~      Within the framework of this investigation it is intended that the hypothesis to be~     substantiated is that carious cavities, which have been treated with the caries infiltration~     technique, exhibit significantly reduced radiological progression than those cavities that~     have been treated using standard preventive treatments.~      In this multicenter trial, a total of 90 test subjects are included and 45 test subjects at~     each institution are to be treated with both, the infiltration technique and using~     conventional fluoridation treatment in different sides of the mouth (split-mouth design).~      The anticipated result of this trial shall deliver information on the long-term effectiveness~     of caries infiltration to prevent the progression of existing approximal carious lesions, and~     thereby enable an improvement in caries prevention within the scope of dental treatment.~   "
105082|NCT02191930|"~     The purpose of this trial is to determine~        1. Objective response rate (ORR), defined as the proportion of patients having CR, CRr or~          PR in the centrally reviewed restaging after six cycles of chemotherapy~        2. Progression-free survival (PFS) 3 years after registration~   "
105083|NCT02191917|"~     Study 701-201 is a study in patients with late-onset Pompe disease (LOPD). The study will~     test respiratory muscle strength initially and again after 24 weeks in subjects treated or~     not treated with BMN 701 .~   "
105084|NCT02191904|"~     To ensure minimal cervical motion during the intubation of trauma patients is important for~     the prevention of cervical spine injury (CSI) or further deterioration of existing CSI.~      Intubation is required to secure the airway in patient during an anesthesia management or a~     mechanical ventilation at intensive care units. Laryngoscopes are the assisting tools for~     intubations. The most widely used laryngoscope type is one with a Macintosh blade. However,~     various types of laryngoscopes have been developed to be used for in case of difficult~     intubations, the intubation of the patients with head and neck trauma, or the intubation~     attempts carried out by inexperienced individuals. Truview EVO2® and Airtraq® are newly~     developed laryngoscopes, integrated with an optical view system.~      The Truphatek TruView EVO2® (Truphatek International Ltd, Netanya, Israel) is a recently~     introduced, easy viewing type of laryngoscope, modified from the blades of Macintosh type~     laryngoscopes, having an angle of 46° at the end of blade and including a camera system that~     magnifies the image.~      The Airtraq® laryngoscope (ATQ; King Medical Systems, Newark, DE) is also a newly developed~     type of laryngoscope, including optical imaging system. There is a channel on the device for~     the placement of the endotracheal tube. Endotracheal tube is inserted into the channel before~     the laryngoscopy. It has been reported that Airtraq is a novel single use laryngoscope which~     provides glottis display without any deviation in the normal position of the oral, pharyngeal~     or the tracheal axes.~      In the literature, there are many studies comparing the effects of these newly developed~     laryngoscopes on cervical motions in different scenarios with cadavers and normal patients.~     However, in these studies, individual vertebral motion was reported during the placement of~     the tube, while the angulation of the head and neck and the difficulty of the intubations~     were not clear.~      In this study our first hypothesis was cervical motion during endotracheal intubation in~     Truview EVO2® and Airtraq® types of laryngoscopes is lesser than Macintosh. The second one~     was the endotracheal intubation time is similar to the Macintosh that is used more often.~   "
105085|NCT02191891|"~     Part A: To determine the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D)~     of Xentuzumab (BI 836845) in combination with afatinib in patients with non-small cell lung~     cancer with progression following prior treatment (EGFR TKI or platinum-based chemotherapy).~      Part B: To evaluate the early anti-tumour activity of Xentuzumab (BI 836845) in combination~     with afatinib in patients with EGFR mutant non-small cell lung cancer with progression~     following prior irreversible EGFR TKIs.~      Part A and B: To evaluate the safety and pharmacokinetics of BI 836845 in combination with~     afatinib in patients with non-small cell lung cancer~   "
105086|NCT02191878|"~     This study is an open-label, multi-center, phase 1, dose escalation study with a phase 2~     expansion cohort to determine the safety, pharmacokinetics and preliminary anti-tumor~     activity of intravenous TKM-080301 in subjects with advanced hepatocellular carcinoma (HCC).~      This study is being done to:~        -  Test the safety and tolerability of TKM-080301 in subjects with advanced hepatocellular~          carcinoma~        -  Find the highest dose of TKM-080301 that can be given without causing side effects,~          called the maximum tolerated dose (MTD).~        -  Provide a preliminary assessment of anti-tumor activity of TKM-080301~   "
105087|NCT02191865|"~     The primary objective of this study is to investigate the effect of mild (Child-Pugh A, score~     5-6) and moderate (Child-Pugh B, score 7-9) hepatic impairment on the pharmacokinetics,~     safety and tolerability of nintedanib, in comparison with a control group with normal hepatic~     function following oral administration of nintedanib as single dose.~   "
105088|NCT02191852|"~     Study to evaluate the total antioxidant capacity of Seresis® (with Thiobarbituric acid~     reactive substances (TBARS) assays)) in the skin; as well as in buccal mucosa cells (BMCs)~     and in plasma, compared to baseline values; furthermore to detect the quantitative enrichment~     of individual antioxidant compounds contained in the product and to investigate whether or~     not some of them accumulate in target tissues such as skin, BMCs and plasma~   "
105089|NCT02191839|"~     Protocol Summary STUDY DESIGN A pilot, prospective, double blind, randomized, placebo~     controlled study.~      STUDY POPULATION Patients assigned to elective CABG with cardiopulmonary bypass (CPB) at the~     Department of Cardiothoracic Surgery, Soroka University Medical Center.~      OBJECTIVE To evaluate anti-inflammatory effects, effects on organ function preservation, and~     postoperative blood loss reduction following AAT-1 administration in patients undergoing CABG~     with CPB.~      PRIMARY ENDPOINT Postoperative organ function preservation and blood loss following~     preoperative single-dose AAT-1 administration.~      SAMPLE SIZE CONSIDERATIONS A cohort of 20 patients will be recruited. Patients will be~     randomized to receive either AAT-1 or placebo prior to surgery. Whereas this is a proof of~     concept pilot study, statistical significance is not the primary objective.~      INCLUSION CRITERIA 1. The study population will comprise patients between 40 and 70 years of~     age, irrespective of gender, at low or intermediate operative risk (calculated Logistic~     Euroscore stratification of 5% or less), assigned to elective CABG with CPB. Recruitment~     depending on patients informed consent.~      EXCLUSION CRITERIA Co-existing conditions including:~        1. Coagulation abnormalities~        2. Severe pulmonary disease defined by blood oxygen saturation of 90% or less or FEV1 of~          less than 60% of predicted.~        3. Renal dysfunction defined be serum creatinine levels higher or equal to 1.8 mg%,~        4. Abnormal liver function tests~        5. Uncontrolled diabetes mellitus,~        6. Severe peripheral vascular disease~        7. Prior cerebrovascular neurological event.~        8. Abnormal left or right ventricular function.~        9. Treatment with warfarin or thienopyridine class of anti platelet agents.~   "
105090|NCT02191826|"~     Clinical proof of concept study to evaluate SOM0226 efficacy in TTR Amyloidosis.~   "
105091|NCT02191813|"~     Study to detect the efficacy of Seresis® in reducing the damage produced on the skin by~     Matrix-metalloproteinases (MMP) and by oxidative stress (marker: heme oxygenase-1 expression)~     activated by UV radiation~   "
105095|NCT02191748|"~     Vitiligo is an autoimmune cutaneous disorder that destroys melanocytes leading to depigmented~     areas of skin. In the United States, vitiligo affects 1% of patients, causing not only~     changes in the color of skin, but also significant cosmetic concerns and quality of life~     issues. Current treatment modalities, which include topical corticosteroids, intralesional~     corticosteroids, phototherapy, and systemic immunosuppression, are variably effective in~     inducing repigmentation. Unfortunately, some cases of vitiligo are refractory to treatment.~     There is a need for new, effective modalities to treat patients with otherwise refractory~     vitiligo.~      Needling is an office based procedure that theoretically transposes healthy, pigmented skin~     cells to depigmented areas using a needle in vitiligo patients. Two preliminary studies of~     needling as a novel treatment for vitiligo had promising results but were limited by small~     sample size and subjective results.~      The proposed randomized control trial (RCT) will further investigate the use of needling to~     treat vitiligo. It differs from the previous studies in that it seeks to identify the cause~     of clinical benefit by comparing needling alone to needling with corticosteroid, examines a~     larger number of patients, and quantifies improvement using confocal microscopy. Confocal~     microscopy (CFM) allows non-invasive visualization of the skin on a cellular level and has~     been used in the past to diagnose cutaneous pigmentary conditions. This study would be the~     first RCT of needling in vitiligo to use an objective measure to quantify results, thus has~     the potential to establish needling as a novel, effective treatment for vitiligo and to~     evaluate the utility of CFM for monitoring response to treatment.~   "
105096|NCT02191735|"~     This clinical investigation is designed to demonstrate the performance characteristics of the~     RAMP® cardiac tests analyzed on the RAMP® 200 by non-laboratorial Operators at the~     point-of-care when compared to the results for the same samples analyzed on the RAMP® Reader.~   "
105097|NCT02191722|"~     We believe, that the results of this study will show that children learn from the comic book~     about their disease, and are now more aware and less frightened about it, and increase their~     compliance.~   "
105098|NCT02191709|"~     Study to investigate the relative bioavailability of orally administered dextromethorphan~     syrup in comparison to dextromethorphan (DMP) soft pastilles in healthy male and female~     subjects who are extensive metabolisers for CYP 2D6~   "
105099|NCT02191696|"~     The purpose is to monitor far field sensing artifacts of CRM devices in the presence of the~     IMED-4~   "
105100|NCT02191683|"~     Study Hypotheses:~        1. Anaemia, which is frequent before conception as well as during early pregnancy, affects~          metabolism and foetal growth trajectories, influencing the risk of NCDs in the~          offspring.~        2. Anaemia from conception till end of 2nd trimester is most detrimental for foetal and~          newborns' health, compared to 3rd trimester anaemia.~        3. Anaemia from conception till end of 2nd trimester affects foetal and newborns health~          through poor placental development reflected in increased villous branching and changed~          umbilical and uterine blood flow.~        4. Anaemia in early pregnancy disrupts the vascular endothelial growth factor A~          (VEGF-A)/placental growth factor (PlGF) balance and the insulin-like growth factor (IGF)~          axis resulting in poor placental development, and poor health of newborns. This may be~          reflected in specific methylation patterns.~        5. Anaemia's impact on the risk for NCDs in the offspring may be mediated via epigenetic~          mechanisms, including changes in DNA methylation patterns.~   "
105101|NCT02191670|"~     Primary: To support the Regulatory Approval process of Metalyse® in Russian Federation.~     Secondary: To assess the efficacy and safety of single bolus of Metalyse® TNK-tissue~     plasminogen activator (TNK-tPA, Tenecteplase ) in patients with acute myocardial infarction~     in usual routine treatment after market launch~   "
105102|NCT02191657|"~     The purpose of this study was to examine the safety, efficacy, and pharmacokinetics of~     different dosages of deferiprone in subjects with or without HIV infection.~   "
105103|NCT02191644|"~     This study examined whether dietary-induced reductions in lipoprotein-associated~     phospholipase A2 (Lp-PLA2) activity in peripheral blood mononuclear cells (PBMC) and plasma~     affected metabolic profiles in PBMCs and plasma.~   "
105104|NCT02191631|"~     The effect of Internet-delivered Cognitive Behavior Therapy (ICBT) on adolescents (12 to 17~     years) with Obsessive-Compulsive Disorder is studied. Participants are randomized to either~     ICBT or a no-treatment condition. We expect ICBT to be superior over the no-treatment~     condition.~   "
105105|NCT02191618|"~     The study is a prospective, multicenter single-arm cohort. Patients with wide neck~     bifurcation aneurysms (WNBAs) have few choices for safe and effective endovascular treatment.~     In this study, all patients with qualifying WNBAs will be treated with the WEB. The primary~     effectiveness outcome of the study is the likelihood of complete intracranial aneurysm~     occlusion on the 1 year angiogram as adjudicated by a core laboratory.~   "
105106|NCT02191605|"~     Marijuana is by far the mostly commonly used illicit drug during pregnancy, and prenatal~     exposure to marijuana can have lasting negative effects. However, current answers to this~     problem are failing to reach most women who use marijuana while pregnant. This project will~     develop and begin testing two technology-based, highly practical interventions that could~     reduce the number of children who are prenatally exposed to marijuana.~   "
105107|NCT02191592|"~     The purpose of this research study is to test a new way of measuring the severity of tinnitus~     using a tool called Ecological Momentary Assessment (EMA) of Tinnitus. We will compare the~     relationship with this tool with another widely used questionnaire. Previous studies we have~     done suggest there are different patterns of tinnitus bother; we plan to explore how often~     these patterns occur, and how many patterns of tinnitus bother there are. And lastly we want~     to test how reliable this type of testing is for measuring the amount of bother people~     experience from their tinnitus.~      Hypothesis 1: We will be able to identify 6 or more distinctive patterns of tinnitus.~      Hypothesis 2: EMA will provide a reliable method for more accurately capturing the amount of~     bother individuals have from tinnitus.~   "
105108|NCT02191579|"~     This study will evaluate the efficacy, safety and tolerability of prophylactic (preventative)~     treatment with BOTOX® (onabotulinumtoxinA) compared to topiramate in adults with chronic~     migraine.~   "
105109|NCT02191566|"~     After curative resection, patients with stage IIIB-IV (M0) gastric cancer were given~     chemotherapy as follows: S-1 orally at 80 mg/m2 divided in two daily doses for 14 days and~     oxaliplatin at 130 mg/m2 intravenously over 2 h every 21 days as one cycle. S1 was~     administered for 16 cycles (12 months) and oxaliplatin for 8 cycles (6 months).~   "
105110|NCT02191553|"~     Mindfulness can be considered as a family of complex attentional and emotional regulation~     strategies that promote the cultivation of well-being and emotional balance. The practice of~     mindfulness produces the development of a consciousness that unfolds moment to moment, open~     and unprejudiced in the present moment, here and now. Despite its extensive benefits, the~     practice of mindfulness requires a significant commitment in time and effort, which limits~     the potential for its dissemination. The studies to narrow the differential effects of the~     various exercises based on mindfulness, will further enhance their effectiveness and they can~     guide the practice sequence according to user needs. In this paper we will research~     mindfulness electroencephalographic correlates of as four different exercise programs~     included in mindfulness-based cognitive therapy (MBCT) and stress reduction program based on~     mindfulness (MBSR) as well as its effect on several psychological variables.~   "
105111|NCT02191540|"~     Phase 3, non-randomized, Multicenter, single arm study to assess efficacy and safety of~     Abnoba viscum F 20mg in patients with malignant pleural effusion~   "
105112|NCT02191527|"~     The general goal of the proposed study is to evaluate the cost-effectiveness of POC~     technologies for diagnosis of syphilis, quantitative analysis for hemoglobin and CD4 counting~     performed within MCH services to improve maternal and infant health.~      A prospective, quasi-experimental study will be done in Cabo Delgado province, where health~     facilities will be randomized in an intervention or comparison arm. Outcomes on maternal and~     infant health will be measured.~   "
105113|NCT02191514|"~     Annually 12.000 people i Denmark suffer from a stroke. Treatment for ischemic stroke is~     available, but only 12% of stroke patients receive it.~      The treatment is only available within a time frame of 4,5 hours from symptom onset, thus the~     Emergency Medical Services (EMS) is essential to fast and effective stroke treatment.~      The aim of this study is:~        1. To establish the rate of recognition of stroke symptoms by healthcare personnel in the~          EMD, ultimately aiming at optimizing performance, and identifying barriers for a fast~          and correct EMS-response.~        2. To assess prehospital time consumption by ambulance personnel on the scene of a stroke,~          create a baseline for future comparison and generate explorative hypotheses for~          forthcoming interventions.~      The overall aim of this study is, to ensure the best possible prehospital care for all stroke~     patients. The study will determine, if the EMD is at a high and international level in~     regards to stroke recognition, and if there is a potential to decrease on-scene time. This~     will serve as future comparison and have an effect on the structure and future education in~     the prehospital services, and potentially improve the outcome after acute ischemic stroke.~   "
105114|NCT02191501|"~     The purpose of this study is to demonstrate the efficacy and safety of endoscopic suturing of~     the gastric pylorus to delay gastric emptying and treat obesity.~   "
105115|NCT02191488|"~     Removing a tumor from a patients brain is hard to do because, very often, brain tumors do not~     have boundaries that are easy for the patients surgeon to find. In many cases, the surgeon~     can't tell exactly where the tumor begins or ends. The surgeon usually can remove most of the~     patients tumor by looking at the MRI images that were taken of the patients brain before~     surgery. However, the surgeon does not have any good way to tell if the entire tumor has been~     removed or not. Removing the entire tumor is very important because leaving tumor behind may~     allow it to grow back which could decrease the chances of survival.~   "
105116|NCT02191475|"~     Selection of tigecycline in severe sepsis and septic shock patients in empirical antibiotic~     therapy (Hai Zheng Energy Star ®) combined with piperacillin / tazobactam (tazocin ®) scheme,~     compared with the classical scheme, evaluate its efficacy, safety index.~   "
105117|NCT02191462|"~     The purpose of this study in to analyse the way in which the body processes Niagen~     (nicotinamide riboside) in healthy people. Blood and urine samples from subjects who are~     given a dose of Niagen will be analyzed for metabolites over the 24 hours after taking the~     dose.~   "
105118|NCT02191449|"~     Warfarin therapy is usually monitored using the international normalized ratio (INR), and~     prolonged INR means coagulation impairment that can leads elevating transfusion requirement~     after operation. This study was designed to assess the relationships with warfarin and TEG~     values related to transfusion amount, to set up blood transfusion strategy in patients on~     atrial fibrillation undergoing cardiac surgery.~   "
105119|NCT02191436|"~     Psychosocial factors and adherence to treatment in patients with hemophilia. A multicenter~     study. Multicenter cross sectional study of patients with hemophilia and their families~   "
105120|NCT02191423|"~     Rationale and Hypotheses of the Current Research: the investigators speculate that mothers~     suffering from PPD exhibit high levels of depression and low levels of OXT, hence~     experiencing the interaction with their child as less rewarding, which in turn promote~     further depressive symptoms and interfere with child development. While dyadic psychotherapy~     has been studied in this context, it is unknown which depressed women will respond to this~     type of therapy, and whether such a response is mediated by the pro-bonding effect of~     oxytocin.~      The aim of this study is three-fold:~        1. To study the effect of the administration of a single dose (24IU) of oxytocin on~          cerebral circuit processing and connectivity of empathy and attachment.~        2. To examine whether the clinical response of mothers suffering from postpartum depression~          to short term dyadic psychotherapy (based on improved mother-child interactions) can be~          predicted by a unique brain response pattern to oxytocin.~        3. To assess the relationship between levels of oxytocin in mother and baby and the~          effectiveness of psychological dyadic treatment on mothers suffering from postpartum~          depression.~   "
105155|NCT02190968|"~     Many patients report residual depressive symptoms despite seemingly successful treatment.~     With the investigators' previous funding, we developed - Mindful Mood Balance - an online~     treatment that targets RDS by teaching specific emotion regulation and depression~     self-management skills that are entirely compatible with antidepressant treatment. The~     investigators now propose a controlled study to determine whether MMB is more effective than~     usual care at reducing RDS and other key outcomes. If successful, MMB's online delivery~     format would provide high fidelity and low-cost empirically supported management of residual~     symptoms, leading to more robust remission, improved functioning and sustained recovery from~     MDD over time.~   "
105645|NCT02184572|"~     The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals'~     trivalent MMR (Priorix®), comparing it to Merck's MMR vaccine (M-M-R®II), which is approved~     for use in the US in healthy children 12 to 15 months of age.~   "
105121|NCT02191410|"~     The stroke volume variation (SVV), measured using the Vigileo-FloTrac system (Edwards~     Lifescience, Irvine, CA), has been shown to able to predict fluid responsiveness during~     one-lung ventilation (OLV) in patients undergoing pulmonary lobectomy (sensitivity: 82.4%,~     specificity: 92.3%).1 Many parameters such as tidal volume (TV),1-2 positive end-expiratory~     pressure (PEEP),3 respiratory rate (RR), 4 chest and lung compliance,5 heart rate and rhythm,~     and ventricular function and afterload,6-7 all have been documented to have effects on the~     SVV.~      SVV is calculated as the variation of beat-to-beat SV from the mean value during the most~     recent 20 seconds of data: SVV = (SVmax − SVmin)/SVmean, where SVmax, SVmin, and SVmean are,~     respectively, the maximum, minimum, and mean SV determined by the system.~      SVV may not be sufﬁciently sensitive to predict fluid responsiveness in patients with right~     ventricular (RV) dysfunction due to concomitant increases in RV afterload, that lead to a~     decrease in preload variation and subsequent inaccuracy in SVV measurements.8~      OLV may increase airway pressure, resulting in increases in the RV afterload, end-diastolic~     volume, and stroke work index, thus impeding RV function.9-11The increases in the right~     ventricular afterload may exaggerate the cyclic variation in stroke volume.12~      In the authors' previous study,9 they found that the high-frequency positive-pressure~     ventilation (HFPPV) was superior to continuous positive-airway pressure (CPAP) for OLV,~     resulting in significantly higher RV ejection fraction, lower RV afterload and higher~     arterial oxygenation, whereas the former limiting the adequate operative field visualization~     during video-assisted thoracoscopic surgery (VATS).13~      The effects of the nondependent lung ventilation with HFPPV and CPAP on the SVV and fluid~     responsiveness during OLV has not yet been studied.~   "
105122|NCT02191397|"~     This multi-centre study will follow a randomised, double-blind, parallel-group,~     active-controlled design and will evaluate the efficacy, safety and tolerability of bupropion~     extended-release (XL) (300 mg/day) compared with escitalopram (10-20 mg/day) in outpatients~     and inpatients with major depressive disorder (MDD). The total duration of the study will be~     11 weeks consisting of three phases. The screening phase (phase I) will be lasting for 0-14~     days, subjects will be randomised to bupropion XL or escitalopram in a 1:1 ratio for acute~     phase treatment phase (phase II) for 8 weeks. There are 3 dose levels during this acute~     treatment phase. The 3-dose level plan is designed to ensure each drug is titrated according~     to the prescribing information and to reach an optimal clinical dose. Finally patients will~     enter the taper phase (phase III) for up to 1 week to assess and reduce the possible~     withdrawal symptoms.~      In China almost all existing antidepressants are available on the market, but bupropion XL~     has not yet been approved. This Phase III clinical trial will be used for the purpose of~     registering bupropion XL in China.~   "
105123|NCT02191384|"~     The purpose of this study is to determine whether Orcinoside Capsule in different doses are~     effective in the treatment of Depression.~      And to explore the preliminary information of safety and efficacy of Orcinoside Capsule in~     the Chinese Patients with Depression.~   "
105124|NCT02191371|"~     One-lung ventilation during thoracic surgery may affect systemic oxygenation and peripheral~     microcirculation by hypoxic pulmonary vasoconstriction. Both intravenous and inhalational~     anesthetics can be used during one-lung ventilation. However, there is still a controversy~     which anesthetic would be more appropriate during one-lung ventilation in the perspective of~     oxygenation and microcirculation. The investigators hypothesized that intravenous and~     inhalational anesthetics may affect oxygenation and microcirculation differently during~     one-lung ventilation.~   "
105125|NCT02191358|"~     This multicenter observational study aims to investigate the benefits of providing~     pharmacogenetic testing with the YouScript Personalized Prescribing System which includes a~     clinical decision support tool and individualized pharmacist recommendations to elderly~     polypharmacy patients who are most at risk of adverse drug events. The YouScript system is~     unique in identifying drug-gene, and drug-drug-gene interactions that are missed by existing~     systems, and represent over 35% of significant interaction warnings. Data analysis will~     assess the impact of recommendations for medication changes on clinical decision making,~     patient outcomes, and healthcare resource utilization to determine which medications,~     specialties, or patient segments derive the greatest benefit from this intervention. Data~     gathered from patients enrolled in this study will be compared to patients matched on key~     characteristics from Inovalon's MORE2 healthcare database.~   "
105126|NCT02191345|"~     Primary Aim A. To determine if listening to prerecorded guided imagery 3 times per week for 4~     weeks will reduce state anxiety, perceived stress, burnout, compassion fatigue, and vicarious~     trauma in Fronltine Service staff.~      Primary Aim B. To determine if staff will continue to listen to guided imagery after the~     first 4 weeks of the study is over.~   "
105127|NCT02191332|"~     Observational study to collect data on maintaining anti-retroviral activity (quantitative HIV~     RNA determination) and immunological activity (CD4 cells) despite switching from protease~     inhibitor to nonnucleoside reverse transcriptase inhibitor (NNRTI) (Viramune®).~   "
105128|NCT02191319|"~     Collecting data on maintaining anti-retroviral activity (quantitative HIV RNA determination)~     and immunological activity (CD4 cells) after switching from protease inhibitor or NNRTI to~     Nevirapine (Viramune®) and collecting of routinely observed laboratory data on lipids, and~     liver enzymes.~   "
105129|NCT02191306|"~     Utilizing Computed Tomographic Angiography to Evaluate Coronary Artery Disease in Patients on~     Long-Term Antiretroviral Therapy~      Intro:~      It is well known that HIV treated with antiretroviral drugs increases the risk for coronary~     artery disease. Studies have documented this with various methods including analyzing the~     effects of retroviral therapy on cardiac risk factors such as diabetes, lipids and~     hypertension. Still other studies have looked at carotid and brachial artery intimal~     thickness. Our study, then, aims to evaluate the relationship between HIV medications and~     coronary atherosclerosis using a novel method. Coronary artery CT angiography is a relatively~     new diagnostic procedure to evaluate heart disease in cardiac patients. We will apply this~     test to HIV patients on longstanding antiretroviral therapy to directly examine their~     coronary arteries to assess heart disease.~      Hypothesis:~      We hypothesize that HIV patients on antiretroviral therapy will have increased coronary~     artery disease compared to the general population.~      Methods:~      This project will be conducted in collaboration between Florida Heart Center and Associates~     in infectious Disease - two communities based infectious disease and cardiology practices. We~     will identify all the HIV positive patients seen within a 1 month timeframe at the infectious~     disease office. These patients will then be filtered by our exclusion/inclusion criteria.~     After obtaining informed consent, we will draw blood from each patient to gather lab values~     such as A1C, cholesterol, inflammatory markers, and other markers associated with coronary~     artery disease. Each enrolled patient will then schedule and receive a 64 slide coronary CTA~     at Florida Heart Center. The results of the CTA scans will be categorized in mild, moderate,~     and severe coronary artery disease. The data, then, will consist of the parameters measured~     on blood work, and the results of the coronary CTA.~      Inclusion Criteria:~      1. Patients aged 35 to 50 with HIV and on retroviral therapy for at least 5 years.~      Exclusion Criteria:~      1. Patients with prior documented coronary artery disease, heart attack, stent placement, or~     heart surgery.~      Statistical Analysis:~      We will conduct a multivariate analysis on the cardiac risk factors taken from patient~     history and the bloodwork (diabetes, lipids etc) to correlate them with the results of the~     CTA. We will also conduct basic analysis to support our hypothesis that long term~     antiretroviral therapy increases coronary artery disease.~      Funding:~      The bloodwork and CTA tests ordered in this study will be payed for by insurance companies~     where available. In cases where insurance companies will not pay, Florida Heart Center will~     pay for the CTA tests and Associates in infectious Disease will fund the bloodwork.~      Humans Subjects Protection:~      This will be a projective chart review study that will require access to protected health~     information. Thus, we will seek full IRB approval from the FSU IRB committee with informed~     consent. An informed consent document will be given to each patient explaining all the risks~     and benefits of the study in addition to the methods. Recruitment will be done by an office~     staff or medical assistant not on the research team. After patient recruitment, their medical~     records will be flagged for study and they will undergo the required testing. At completion~     of testing, their results will be recorded in the final data sheet, and their medical record~     will no longer be flagged for study. No identifying data will be recorded in the final data~     sheet, and the data will be stored in an encrypted excel sheet on a secure password protected~     personal laptop running antivirus and firewall. Third parties (such as family members) will~     not have access to any research data regardless of authorizations received from the study~     subjects. All the test results and labwork performed for the study will go into the patient's~     individual medical record at their respective offices. Thus, if an authorized third party~     wishes to view any test results, they can do so via the normal methods at the doctor's~     office.~   "
105130|NCT02191293|"~     Collecting data on maintaining anti-retroviral activity (quantitative HIV RNA determination)~     and immunological activity (CD4 cells) after switching from protease inhibitor or NNRTI to~     Nevirapine (Viramune®) and collecting of routinely observed laboratory data on lipids, and~     liver enzymes.~   "
105131|NCT02191280|"~     Study to determine the efficacy and tolerability of two dose levels of Antistax relative to~     placebo in patients suffering from CVI grade I or incipient grade II~   "
105153|NCT02190994|"~     The purpose of this four-arm randomized controlled study is to determine whether eliminating~     glucocorticoids (GC) replacement in perioperative period in surgical patients with sellar~     lesion could result in similar or better outcomes comparing to traditional replacement~     therapy, regarding postoperative recovery of pituitary function and other postoperative~     complications (infection, pain, quality of life, recurrence). Surgical patients of our center~     with MRI-confirmed diagnosis of sellar lesion will be enrolled, insulin tolerance test (ITT)~     will be performed for assessment of the pituitary function at enrollment. Patients with~     normal pituitary function will be randomized into non-GC replacement group (group A) and~     low-dose GC replacement group (group B), while patients with impaired pituitary function will~     be randomized into low-dose GC replacement group (group C) and high-dose GC replacement group~     (group D). The primary outcome is the hypothalamic-pituitary-adrenal (HPA) -axis function of~     the patients, evaluated by plasma cortisol and adrenocorticotropic hormone (ACTH) levels. The~     secondary outcomes include the hypothalamic-pituitary-thyroid (HPT) axis function (TSH,~     thyroid-stimulating hormone, free T3, free T4), postoperative water-electrolyte balance,~     infection, recurrence and health-related quality of life.~   "
105132|NCT02191267|"~     Chronic traumatic encephalopathy (CTE) is a progressive degenerative brain disease with~     symptoms that include memory loss, problems with impulse control, and depression that can~     lead to suicide. As the disease progresses, it can lead to dementia. Currently CTE can only~     be diagnosed postmortem where an over-accumulation of a protein called tau is observed. There~     is now a new experimental measure that makes it possible, for the first time, to measure tau~     protein in the living human brain using a novel positron emission tomography (PET) ligand,~     [F-18] AV-1451 (aka, [18F]-T807).~      The main objective of this study is to use a novel PET approach to measure tau accumulation~     in the brain. The presence of CTE at autopsy in deceased National Football League (NFL)~     players has been well documented. Accordingly, we will conduct this study in a group of~     retired NFL players who have clinical symptoms of CTE and are suspected of having CTE based~     on high levels of tau in their spinal fluid and abnormalities seen on research brain scans.~     We will compare them with a control group of former elite level athletes who have not~     experienced any brain trauma, deny any clinical symptoms, and who have completely normal~     spinal fluid tau and amyloid levels, and brain scans. We will also include a group of~     subjects with AD. All participants will be recruited from ongoing studies, headed by the~     Partnering PI of this proposal, Dr. Robert Stern, at the Boston University Center for the~     Study of Traumatic Encephalopathy and the Alzheimer's Disease Center. We will use both a beta~     amyloid PET scan ([18F]-florbetapir) and a tau PET scan ([18F]-T807) on consecutive days.~     With the beta amyloid scan we expect little or no evidence of amyloid in the NFL players with~     presumed CTE, and no evidence of amyloid in the control group of athletes with no history of~     repetitive brain trauma. In contrast we expect to see beta amyloid accumulation in the AD~     patient brains. With the new tau ligand, we expect that the NFL players with presumed CTE~     will show elevated levels of tau protein in the brain, which will not be observed in athletes~     without a history of brain trauma, but which will be seen in the AD patients' brains.~      Another goal is to use the latest MRI technologies to develop specific tau imaging biomarkers~     that correlate with the PET and spinal fluid tau measures but without the radiation of PET or~     invasiveness of spinal taps. The development of these surrogate imaging markers of tau, is~     critically important to diagnosing CTE. This in turn will lead to studies relevant to~     treatment and prevention of this devastating disease. Finally, as an exploratory method of~     examining possible genetic risk for CTE, we will also use cutting edge genetic analysis of~     blood samples from subjects in this proposal and compare tau load, measured by PET tau ligand~     uptake and cerebrospinal fluid (CSF) p-tau level, with a measure of genetic susceptibility to~     tau load, referred to as the genetic risk score for tau.~   "
105133|NCT02191254|"~     Study to assess the efficacy and tolerability of Antistax® film-coated tablets in patients~     with chronic venous insufficiency (CVI, Clinical condition, Etiology, Anatomic location,~     Pathophysiology (CEAP) Classification: Clinical Class 3, or 4a)~   "
105134|NCT02191241|"~     To describe the plasma and urinary pharmacokinetics of quercetin glucuronide and kaempferol~     glucuronide after the administration of a single peroral dose of 1,800mg Red Vine Leaf~     Extract (Antistax®). Additionally, the trial evaluated the safety and tolerability of this~     dose in healthy subjects.~   "
105135|NCT02191228|"~     The main objective of this study was to assess the effect of normal and impaired renal~     function on the safety, pharmacokinetics, and pharmacodynamics of linagliptin following oral~     administration of 5 mg daily for 7 days (Groups 1 to 3), 5 mg daily for 10 days (Groups 6 and~     7), or as a single dose (Groups 4 and 5)~   "
105136|NCT02191215|"~     The aim of the Post Marketing Study (PMS) is to evaluate the efficacy and safety profile of~     nevirapine in the management of the HIV/AIDS in an open environment.~   "
105137|NCT02191202|"~     Observational study to evaluate therapeutic switch to a NNRTI-based regimen on quality of~     life of HIV-positive patients~   "
105138|NCT02191189|"~     Study to determine the absorption of Nevirapine from different regions of the Gastro~     Intestinal tract.~   "
105139|NCT02191176|"~     The primary objective of the current study is to investigate the safety with special emphasis~     on ECG effects, and tolerability of dextromethorphan hydrobromide monohydrate (2mg/mL syrup)~     in healthy male and female subjects following oral administration of 30 mg q.i.d. and 90 mg~     q.i.d. for 2 days followed by a single morning dose (extensive metabolisers of CYP 2D6) and~     for 10 days followed by a single morning dose (poor metabolisers of CYP 2D6).~      Additionally pharmacokinetic properties of dextromethorphan and its main metabolites~     dextrorphan, 3-hydroxymorphinan, and 3-methoxymorphinan will be investigated~   "
105140|NCT02191163|"~     Study to determine the efficacy and safety of Antistax® film coated tablets in improving~     microcirculation of the skin in the leg of patients with chronic venous insufficiency (CVI)~   "
105141|NCT02191150|"~     The study will obtain data to show insight into clinical outcomes of patients switching from~     Darbepoetin Alfa to a epoetin alfa biosimilar.~   "
105142|NCT02191137|"~     The MOTION study was a prospective, Phase IV study for patients with Pulmonary Arterial~     Hypertension (PAH). The study was designed to further explore patient-reported outcomes in~     PAH subjects who were not on active treatment and living in the United States. In addition,~     the study explored the use of new telemetric technology (Accelerator band) to evaluate if~     this technology correlates with improvements in 6 Minute Walking Distance 6MWD in patients~     with PAH.~   "
105143|NCT02191124|"~     In recent years, measurement-based care (MBC) has been gaining more attention in the~     treatment of depression because it allows psychiatrists to individualize treatment decisions~     for each patient based on the change of psychopathology and tolerance toward antidepressants.~     Several studies, such as the Sequenced Treatment Alternatives to Relieve Depression (STAR*D)~     trial using MBC, found that MBC-informed sequential algorithms can be successfully integrated~     into clinical practice and improve patients' outcomes However, despite a strong theoretical~     rationale for MBC and data supporting the ability to implement MBC in clinical practice~     settings, there is currently no randomized controlled trial in MDD patients comparing MBC~     with usual/standard care. The investigators compare MBC with clinician's treatment decisions,~     standardizing care to two commonly prescribed antidepressants.~      Therefore, the aim of this study is to determine the effects of MBC in patients with MDD~     compared to standard treatment (ST). The research hypothesis is that compared to ST, the~     estimated time to response and to remission would be significantly shorter in the MBC group~     without increased dropout rates and side effect burden.~   "
105154|NCT02190981|"~     The primary purpose of this study is to determine the accuracy of ultrasound in diagnosing~     small bowel obstruction in emergency department patients, as compared to the criterion~     standards of computed tomography, operative reports, or discharge diagnosis.~      The secondary purposes of the study include evaluation of the effect of ultrasound for small~     bowel obstruction on the patient length of stay in the emergency department and the~     diagnostic utility of specific ultrasound findings in the diagnosis of small bowel~     obstruction. The study will also examine the inter-rater agreement between point-of-care~     sonographers' interpretation and blinded reviewers' interpretation of the ultrasound images.~   "
105156|NCT02190955|"~     The purpose of this study is to learn about patient, caregiver and healthcare worker~     perspectives on educating patients with newly-diagnosed Nephrotic Syndrome. All patients~     enrolled in the Contact Registry with Nephrotic Syndrome will be invited via email to~     participate in this study.~   "
105144|NCT02191111|"~     Background: Despite evidence of benefit for pharmacist involvement in chronic disease~     management, the provision of these services in community pharmacy has been suboptimal. The~     Promoting Action on Research Implementation in Health Services (PARiHS) framework suggests~     that for knowledge translation to be effective, there must be evidence of benefit, a context~     conducive to implementation, and facilitation to support uptake. We hypothesize that while~     the evidence and context components of this framework are satisfied, that uptake into~     practice has been insufficient because of a lack of facilitation. This protocol describes the~     rationale and methods of a feasibility study to test a facilitated pharmacy practice~     intervention based on the PARiHS framework, to assist community pharmacists in increasing the~     number of formal and documented medication management services completed for patients with~     diabetes, dyslipidemia, and hypertension.~      Methods: A cluster-randomized before-after design will compare ten pharmacies from within a~     single organization, with the unit of randomization being the pharmacy. Pharmacies will be~     randomized to facilitated intervention based on the PARiHS framework or usual practice. The~     Alberta Context Tool will be used to establish the context of practice in each pharmacy.~     Pharmacies randomized to the intervention will receive task-focused facilitation from an~     external facilitator, with the goal of developing alternative team processes to allow the~     greater provision of medication management services for patients with diabetes, hypertension,~     and dyslipidemia. The primary outcome will be a process evaluation of the needs of community~     pharmacies to provide more clinical services, the acceptability and uptake of modifications~     made, and the willingness of pharmacies to participate. Secondary outcomes will include the~     change in the number of formal and documented medication management services in the~     aforementioned chronic conditions provided 6 months before, versus after, the intervention~     between the two groups, and identification of feasible quantitative outcomes for evaluating~     the effect of the intervention on patient care outcomes.~      Results: To date, the study has identified and enrolled the ten pharmacies required and~     initiated the intervention process.~      Conclusion: This study will be the first to examine the role of facilitation in pharmacy~     practice, with the goal of scalable and sustainable practice change.~   "
105145|NCT02191098|"~     To assess the safety and tolerability of ALT-803, as well as, the potential efficacy of~     ALT-803 in HIV~   "
105146|NCT02191085|"~     Access to medical care for patients with breathing disorders during sleep is a major problem~     for Canadians. Recently, there has been increasing interest in how health care providers who~     are not physicians can help to improve access to medical care for these patients, but it is~     unclear whether patients with severe sleep-disordered breathing who receive care from these~     non-physician providers have the same response to treatment as patients who receive care from~     physicians. Since these severe have a high risk of developing cardiac and respiratory~     complications and of being hospitalized, an initiative to improve access such as the use of~     non-physician providers could be of great benefit to individual patients and the health care~     system.~      The objectives of this project are:~        1. to determine whether patients with severe breathing disorders during sleep have the same~          response to treatment when cared for by non-physician health care providers (respiratory~          therapists) as they do when cared for by physicians;~        2. to determine the effects of non-physician health care provider treatment to patient~          access;~        3. to determine health care utilization and related costs associated with non-physician~          health care provider treatment.~   "
105147|NCT02191072|"~     Efficacy of omalizumab in chronic spontaneous urticaria had been demonstrated in phase II and~     phase III studies. Clinical symptoms and signs had been significantly reduced with omalizumab~     as doses of 150 mg and 300 mg at 4-week intervals in patients with chronic spontaneous~     urticaria who remained symptomatic despite antihistamine treatment. Omalizumab had an onset~     of effect within a week after initiation. Thus, the investigators hypothesize that omalizumab~     will be effective in the treatment of severe acute urticaria as add on therapy with a fast~     onset of action. Objective:To investigate the efficacy and safety of omalizumab in the~     treatment of severe acute urticaria Study design: This prospective, interventional,~     single-arm open label study will recruit patients with severe acute urticaria from emergency~     departments, hospitalized and outpatient departments. The included patients will receive a~     single subcutaneous dose of 300mg omalizumab therapy. The efficacy of omalizumab will be~     evaluated by physical examination and assessed by Urticaria Activity Score (UAS) at baseline,~     1 hour, Day 1, Day3, Day 7, and 6 weeks after omalizumab therapy. The frequency and severity~     of treatment-emergent adverse events will also be evaluated~   "
105148|NCT02191059|"~     1. There is as yet no optimal treatment regimen for patients with epidermal growth factor~          receptor (EGFR) gene wild type non-small-cell lung cancer (NSCLC) .~        2. Icotinib is a new type of small molecule EGFR TKI, developed and patented by Zhejiang~          BetaPharma Co., Ltd.(Hangzhou, Zhejiang, China, Patent No. WO2003082830). It has the~          similar anti-tumor activity with gefitinib, erlotinib. Pre-clinical studies showed~          icotinib could significantly inhibit the EGFR tyrosine kinase activity. Notably,~          anti-tumor activities were observed in patients with advanced NSCLC.~        3. In this study, we will evaluate the efficiency of intermittent high dose of Icotinib in~          combination with Docetaxel as second-line treatment for NSCLC patients with wild type~          EGFR. The overall response rate(ORR),progression free survival(PFS) ,overall~          survival(OS) and health related quality of life(HRQoL) will be monitored.~   "
105149|NCT02191046|"~     The purpose of this study is to the effect of squeezable bottle nasal irrigation device with~     syringe in children with sinusitis in symptom score and satisfaction to nasal irrigation~   "
105150|NCT02191033|"~     This study is a randomized-controlled clinical trial which evaluates the efficacy of~     physician brief advice, nicotine replacement therapy and a 6-week course of text messaging in~     promoting cigarette smoking in smokers enrolled in college.~      The primary hypothesis is that smokers receiving physician brief advice, nicotine replacement~     therapy, and text messaging will have higher quit rates that smokers receiving physician~     brief advice and nicotine replacement therapy alone.~   "
105151|NCT02191020|"~     This is a randomized, double blind, placebo parallel-controlled, multi-center clinical trial.~     Patients with psoriasis vulgaris were randomly divided into the experiment group （treated~     with TGP combined with acitretin capsules) and control group （treated with placebo combined~     with acitretin capsules）.The treatment lasted 12 weeks. The efficacy and safety were~     evaluated at the baseline, as well as 2, 4, 8 and 12 weeks after the beginning of~     treatment.The investigator's hypothesis TGP combined with Acitretin Capsulesin is more safe~     and effective than Acitretin Capsulesin to treat Psoriasis Vulgaris.~   "
105152|NCT02191007|"~     Evaluate the efficacy and safety of Calcipotriol Betamethasone Ointment and Calcipotriol~     Ointment in sequential therapy~   "
105157|NCT02190942|"~     The purpose of this study is to provide validation of patient-reported data in the VCRC~     Patient Contact Registry by comparing patient-reported data with data provided by the~     physician who is the primary provider caring for the patient's vasculitis. Patients enrolled~     in the Patient Contact Registry with Behcet's disease, eosinophilic granulomatosis with~     polyangiitis (Churg-Strauss) (EGPA), giant cell arteritis (GCA), granulomatosis with~     polyangiitis (Wegener's) (GPA), microscopic polyangiitis (MPA), polyarteritis nodosa (PAN),~     and Takayasu's arteritis (TAK) were invited via email to participate in this study.~   "
105158|NCT02190929|"~     A cross-sectional study design and online questionnaire was used to assess the informational~     needs of patients with several different types of systemic vasculitis. Patients were~     recruited from within the Vasculitis Clinical Research Consortium (VCRC) online Patient~     Contact Registry1. Survey responses from participants in the VCRC Patient Contact Registry~     were compared to responses from a similar survey recently administered to patients within a~     United Kingdom (UK) based vasculitis support group (Vasculitis UK).~   "
105159|NCT02190916|"~     The purpose of this study is to learn about how patients with vasculitis think about their~     illness and to assess to what extent patient perceptions of illness are associated with~     physical, mental, and social functioning~   "
105160|NCT02190903|"~     This pilot project will address the gaps in knowledge regarding the effect of anesthetic~     technique on the risk of delirium through an adequately-powered trial employing standardized~     regimens for treatment and outcome assessment to test the hypothesis that use of spinal~     versus general anesthesia decreases the risk of delirium after hip fracture surgery.~   "
105161|NCT02190890|"~     The purpose of this study are (1) to determine the effectiveness of different dry needling~     dosages in the treatment of myofascial trigger points in the upper trapezius muscle in~     patients with myofascial neck pain, (2) to assess postneedling soreness and tenderness and~     (3) evaluate the influence of psychological factors on the perception of postneedling~     soreness.~   "
105162|NCT02190877|"~     This study is designed to validate ease-of-use for the CoVa Monitoring System, along with~     simple statistical parameters such as reproducibility and inter-subject agreement between~     test and reference devices.~   "
105163|NCT02190864|"~     Our long-term goal is to integrate non-small cell lung cancer patient treatment preferences~     into clinical treatment planning.~   "
105164|NCT02190851|"~     Only one study has evaluated the effect of TENS in LUTD in Parkinson's syndromes. It was~     reported at the congress of the Société Interdisciplinaire Francophone d'UroDynamique et de~     Pelvi-Perinéologie (SIFUD-PP) in 2011 by Ohanessian et al., and comprised 6 female patients~     with Parkinson's disease (PD) or multisystem atrophy (MSA), with overactive bladder.~     Transcutaneous electrical nerve stimulation, 20 minutes daily for 6 weeks, was associated~     with subjective improvement of LUTD assessed with the Patient Global Impression of~     Improvement (PGI-I) in 5 of the 6 patients.~      In view of the encouraging results of this pilot study, we hypothesize that TENS treatment~     may improve LUTD in patients with a Parkinson's syndrome, Parkinson's disease (PD) and~     multisystem atrophy (MSA).~   "
105165|NCT02190838|"~     Treatment of disseminated melanoma is still a difficult issue. Obvious achievements of recent~     years proves efficacy of immunologic approachees in this field. The ability of melatonin and~     metformin to decrease metabolic immunosuppression was shown in many experimental studies.~     Some literature data confirm the possibility of increasing efficacy of melatonin with~     dacarbazine (DTIC) and metformin with DTIC combinations. We hypothesized that this~     combinations could be more effective than DTIC monotherapy in terms of response rate and time~     to progression.~   "
105166|NCT02190825|"~     This study aims to investigate the safety, efficacy, peri and postoperative complications,~     and patient satisfaction of sacro-spinous ligament fixation (SSLF) for the management of~     pelvic organ prolapse (POP).~      Prolapse staging for all subjects in this study will be performed according to the POP-Q~     staging system.~      Ultrasound examinations for all subjects in this study are subjected to the surgeon need and~     will be performed if required by qualified personnel~   "
105167|NCT02190812|"~     Use the system to evaluate of wrist muscle strength.~   "
105168|NCT02190799|"~     Since the first report of the Middle East Respiratory Syndrome Corona virus (MERS- CoV) in~     September 2012, more than 800 cases have been reported to the World Health Organization (WHO)~     with substantial mortality.~   "
105169|NCT02190786|"~     The purpose of this study is to investigate the efficacy, safety and pharmacokinetics of~     multiple oral administration of KUX-1151 in patients with hyperuricemia including gout.~   "
105170|NCT02190773|"~     In the present clinical study including chronic, aggressive periodontitis and healthy~     individuals, the investigators aimed to determine the RANKL, osteoprotegrin (OPG),~     Interleukin-1 (IL-1β), IL-10, IL-1β levels in gingival crevicular fluid(GCF) before and after~     surgical periodontal treatment and search out the relationship of clinical parameters with~     these cytokine levels.~   "
105171|NCT02190760|"~     The addition of dexamethasone (DxaM) to local anesthetic may significantly prolong the~     duration of a block. The aim of this study is to determine whether this a systemic or local~     effect.~   "
105172|NCT02190747|"~     Fibrodysplasia ossificans progressiva (FOP) is a rare, severely disabling disease~     characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) that result~     in abnormal bone formation in muscles, tendons, and ligaments. Flare-ups begin early in life~     and may occur spontaneously or after soft tissue trauma, vaccinations, or influenza~     infections. Recurrent flare-ups progressively restrict movement by locking joints leading to~     cumulative loss of function and disability. Mouse models of FOP have demonstrated the ability~     of retinoic acid receptor (RAR) gamma agonists to prevent heterotopic ossification (HO)~     following injury. The purpose of the study is to evaluate whether palovarotene, an RAR gamma~     agonist, will prevent HO during and following a flare-up in subjects with FOP.~   "
105173|NCT02190734|"~     Some individuals demonstrate pushing behaviors after having a stroke. The purpose of this~     study is to see if there are immediate changes in pushing behaviors in individuals who have~     had a stroke before and after sitting in a wheelchair, walking on the treadmill, and walking~     overground.~      The investigators do not think there will be a change with sitting in the wheelchair, but the~     investigators think there may be an improvement in pushing behaviors after walking training.~   "
105174|NCT02190721|"~     The purpose of the study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and~     efficacy of daily subcutaneous administration of 5 μg/kg tbo-filgrastim in infants, children~     and adolescents with solid tumors without bone marrow involvement.~   "
105186|NCT02190565|"~     The purpose of this study is to determine whether a food supplement consisting of vitamins,~     minerals and fish oil taken during and after pregnancy can decrease the need for additional~     iron supplementation due to anemia during pregnancy, and optimize levels of nutritional~     markers such as vitamin D and docosahexaenoic acid (DHA, an omega 3 fatty acid) in maternal~     blood and breast milk, compared to placebo.~   "
105175|NCT02190708|"~     Midazolam is a rapid-acting benzodiazepine, with a short half-life (approximately 1.9 hours)~     and is primarily metabolised by CYP3A.~      Omeprazole is a selective proton pump inhibitor substrate used to reduce gastric acid~     secretion. Omeprazole is primarily metabolised by CYP2C19.~      Midazolam and omeprazole are both used as probe drugs in clinical pharmacology studies to~     evaluate clinical CYP3A and CYP2C19 drug interactions, respectively. Furthermore the EMA and~     the FDA guidance on drug interactions recommend the use of these drugs for such evaluations.~      The aim of this study is to assess the effect of PQ912 on the PK of midazolam and omeprazole.~     In vitro studies have demonstrated that PQ912 inhibits several CYP enzymes, including CYP3A4~     and CYP2C19 and at the expected exposure levels in patients, has the potential to inhibit~     these enzymes in-vivo. This study is therefore planned to investigate the potential changes~     in the PK of midazolam and omeprazole due to the effect of PQ912 at steady-state. In clinical~     practice it is likely that co-administration of PQ912 with other drugs that are metabolised~     via the CYP3A and/or CYP2C19 enzymes will occur. This study will provide important~     information for the requirement of dose adjustments or contraindications in these~     circumstances.~   "
105176|NCT02190695|"~     The purpose of this study is to find a new way to treat Acute Myeloid Leukemia (AML),~     Myelodysplastic Syndrome (MDS) and Chronic Myelomonocytic Leukemia (CMML). All the drugs are~     used to treat AML and MDS but are not usually combined together. The investigators are~     looking at both the safety and Efficacy of each combination.~   "
105177|NCT02190682|"~     Postoperative Persistent Pain (PPP) is reported with a high incidence in adults 11.5-47%.~     This high incidence effects quality of life of patients causes social-economical problems and~     arises medico-legal issues. This study will be undertaken for producing a database by the~     evaluation of surgeries in 4 hospitals located in Istanbul. This database will be used in~     establishing a software by using data mining technology in the prediction of PPP~   "
105178|NCT02190669|"~     This proposal seeks to gather continuous blood glucose and physical activity data from~     individuals with and without diabetes.~   "
105179|NCT02190656|"~     Bowel cancer is the third most common cancer in the UK in both males and females. The rectum~     is the most commonly affected part of the bowel. Improvements in surgery have meant that many~     patients with rectal cancer can now undergo surgery that removes the rectum and avoids a~     permanent stoma. The operation that most patients have is an anterior resection of the~     rectum.~      Unfortunately this surgery frequently leads to a change in bowel function, with patients~     suffering from incontinence, urgency and unpredictability a problem known as anterior~     resection syndrome. These problems are believed to be fairly common following surgery but~     follow up appointments have traditionally concentrated on ensuring that the cancer has not~     returned and have not reviewed functional outcomes in enough detail. Because of this we are~     unsure exactly how common the problems described are.~      The proposed study will allow us to determine how many patients have ongoing symptoms~     following their surgery for rectal cancer. It will also allow us to use a newly developed~     scoring system the Low Anterior Resection Syndrome (LARS) score for the first time in a UK~     population, to ensure that it can accurately be used in the future to measure the problem and~     aid development of new therapies. An appreciation of the impact of symptoms on postoperative~     quality of life will encourage routine assessment of functional outcomes in clinical~     practice, allowing identification of patients who may benefit from treatment.~   "
105180|NCT02190643|"~     The goal of this study is to evaluate a smoking cessation program for Latino HIV-positive~     smokers focused on improving adherence to using the nicotine skin patch.~   "
105181|NCT02190630|"~     The aim of this study is to assess skeletal (bone) and dental (teeth) changes occurring~     following wear of a twin block functional appliance (removable brace which postures the lower~     jaw forward to improve a discrepancy between the upper and lower jaw) for differing time~     periods.~   "
105182|NCT02190617|"~     The primary hypothesis the investigators will test is that that improving asthma guideline~     implementation and providing patients with a unified asthma management plan using a~     multi-component and multilevel intervention will improve patient-centered asthma outcomes~     compared to health plan case management, passive guideline dissemination and provider~     education.~   "
105183|NCT02190604|"~     This study is designed to assess the safety, tolerability, pharmacokinetics and preliminary~     pharmacodynamics (proof of concept) of QBW251 in healthy subjects and cystic fibrosis~     patients following single and multiple doses. This first-in-human and proof of concept study~     will consist of 4 parts, with Parts 1 and 2 in healthy volunteers and Parts 3 and 4 in cystic~     fibrosis patients.~   "
105184|NCT02190591|"~     The purpose of the study is to look at the impact of using the Peanut Labor Ball (PLB) after~     epidural anesthesia in patients who have never given birth. The study will measure the impact~     on the length of labor, cesarean section rate, operative vaginal delivery rate (vacuum or~     forceps use), and third or fourth degree laceration rates. This study will determine the~     impact of PLB use by comparing two cohorts of nulliparous patients: one with the PLB use and~     one with traditional wedge and pillow positioning. If benefits related to use of the PLB can~     be demonstrated, it is our intention that each labor room will be stocked with a PBL for use~     as standard of care.~      This study will test the following hypotheses:~        1. The Peanut Labor Ball (PLB) will impact the cesarean section and operative vaginal~          delivery rate in low risk nulliparous patients who receive epidural anesthesia compared~          to similar cohort using traditional wedge and pillow positioning.~        2. Using the PLB will impact the amount of time from epidural placement to complete~          dilation and the time of second stage of labor, when compared with the control cohort.~        3. Use of the PLB will impact the third and fourth degree laceration rates when compared~          with the control cohort.~   "
105185|NCT02190578|"~     To determine the efficacy of an improved rapid diagnostic test using venous whole blood and~     fingerstick whole blood. The clinical performance of Reveal G4 Rapid HIV-1 Antibody Test will~     be determined by comparing the results with patient infected status for HIV-1 (human~     immunodeficiency virus type 1).~      The study will consist of a single one-hour visit, at which time blood samples will be~     collected and tested with the investigational device (Reveal G4) and FDA approved comparator~     assays for detection of HIV-1 antibodies.~   "
105224|NCT02190071|"~     The purpose of this study is to determine whether there is a difference of diagnostic~     accuracy between cover slides and base slides from EUS-FNA cytopathologic sample in patients~     who were previously suspected of pancreatic cancer in radiologic test.~   "
105187|NCT02190552|"~     A.R.I.S.E. is a post approval observational study using standard care. The purpose of this~     study is to collect information about the ability of the EmboTrap device to remove blood~     clots from the brain, and the associated performance characteristics and clinical outcomes.~     No formal hypothesis testing is needed as no comparisons are planned within the study.~     Instead, estimates of each population parameter of interest for all primary and secondary~     endpoints will be provided using appropriate confidence intervals.~   "
105188|NCT02190539|"~     The objective of this study is to conduct a feasibility study at Meir Oncology Institute~     examining whether patients with advanced breast cancer would follow a homeopathic protocol~     for three to six months.~      The primary aim of the study is to establish if patients with advanced breast cancer in Meir~     Oncology Institute would follow a regimen of treatment as used by Dr Banerji in India, for~     six months.~      The secondary aim is to observe the quality of life and wellbeing of patients undergoing this~     protocol~   "
105189|NCT02190526|"~     The aim of this study is to evaluate the effects of Mesalamine and Amitriptyline drugs on the~     Quality of Life and Symptom Severity Scale in patients with Diarrhea- Predominant Irritable~     Bowel Syndrome (IBS-D).~      All patients will fill three validated questionnaires (IBS Symptom Severity Scale (IBS-SSS) ,~     Hospital Anxiety and Depression Scale (HADS ) and IBS Quality of Life (IBS-QOL) ) at the~     beginning of trial and at weeks 2,4,6 and 8 of treatment.~      Serum Immune Bio markers will be measured at 0,4, and 8 weeks of treatment. This study is a~     clinical trial upon 90 patients with Diarrhea- Predominant IBS (IBS-D) who are referred for~     the first time to our private gastrointestinal clinic from 2014 until 2016.~      All patients who meet the inclusion criteria enrolled for a 2-week period screening phase. In~     order to exclude patients with Lactose intolerance, all patients take a lactose-free diet for~     14 days before inclusion and patients whose symptoms improve by this regimen will be~     excluded.~      This trial is a double-blind study and all patients will be assigned randomly to three~     groups:~        1. Mesalazine group: Patients receive Asacol (800 mg/TDS) and a placebo agent similar to~          Amitriptyline (10 mg/HS) for 8 weeks~        2. Amitriptyline group: Patients receive Amitriptyline (10 mg/HS) and a placebo like Asacol~          (800 mg/ TDS) for 8 weeks~        3. Control group (placebo group): Patients receive placebo like Asacol (800 mg/TDS) and~          placebo similar to Amitriptyline (10 mg/HS) for 8 weeks~      Ethical considerations:~        1. All patients will fulfill an informed consent~        2. Drugs are available without any charge~        3. Observation of Helsinki ethical statement~   "
105190|NCT02190513|"~     Celiac disease (CD) and eosinophilic esophagitis (EE) are distinct diseases of the~     gastrointestinal tract with specific clinico-pathological characteristics. In recent years,~     in the literature, several children who underwent upper gastrointestinal endoscopy for~     suspected CD, which was confirmed histologically, were also found to have coexistent EE.~     There are reports of coexistent CD and EE. We would like to see the prevalence of EE in~     children with CD and the prevalence of CD in children with EE in our population, and to do so~     would like to review medical records. Our objectives are to determine if children with celiac~     disease have a high prevalence of eosinophilic esophagitis.and to determine if children with~     eosinophilic esophagitis have increased risk of developing celiac disease.~   "
105191|NCT02190500|"~     The primary goal of this project is to carry out a trial comparing pre-hospital diagnosis and~     treatment of patients with stroke symptoms using a Mobile Stroke Unit (MSU) with subsequent~     transfer to a Comprehensive Stroke Center (CSC) Emergency Department (ED) for further~     management, to standard pre-hospital triage and transport by Emergency Medical Services (EMS)~     to a CSC ED for evaluation and treatment (Standard Management-SM).~   "
105192|NCT02190487|"~     Acute kidney injury (AKI) is one of the most frequently encountered and prognostically~     significant complications after cardiovascular surgery. However, there is no definitive~     treatment to intervene after development of AKI, therefore, preventive strategy has been the~     major issue. By this time, incidence of AKI after cardiovascular surgery has been reported~     3-50% based on the studies with various definition of AKI and different patient cohorts.~     Development of unified definition for AKI in the early 2000s opened a new era in AKI study.~      According to the previous studies, aortic surgery, especially thoracic aortic surgery was~     known to be highly prevalent of AKI, which was considered to be caused by use of total~     circulatory arrest (TCA), relatively high number of emergency cases, combined malperfusion~     syndrome before surgery and relatively complicated surgical procedure. However, there has not~     been many studies of AKI in thoracic aortic surgery because of its low incidence and urgent~     clinical presentation of aortic pathology, which hinder large randomized controlled study.~     Moreover, there are conflicting reports of incidence and risk factors of AKI after thoracic~     aortic surgery, no conclusive result has been made. Therefore, this study was designed to~     investigate the incidence and risk factors after thoracic aortic surgery only due to~     dissection.~   "
105193|NCT02190474|"~     The primary objective of this study to determine the feasibility and acceptability of a~     mindfulness intervention for adolescents with juvenile fibromyalgia/ chronic widespread pain~     and other similar chronic symptoms.~   "
105194|NCT02190461|"~     Open clinical trial with 1 year follow up comparing the impact of an Early Respiratory~     Rehabilitation program with the conventional Respiratory Rehabilitation in COPD re-admitted~     patients. Outcomes will be exacerbations, symptoms, functional capacity and quality of life~     related to health (HRQOL).~   "
105195|NCT02190448|"~     The overall aims of this project are to 1) determine the quality of life effects and safety~     of a combination herbal galactagogue tea in lactating women, and 2) measure changes in~     maternal blood concentration of oxytocin, prolactin, and milk production. The defined outcome~     measures will include quality of life measures and safety parameters in the breastfeeding~     woman and basic infant health. If the tea proves safe and effective, then it can provide a~     proven all-natural and organic supplement for increasing lactation in women. This in turn~     will increase quality of life for both the infant and the mother.~   "
105225|NCT02190058|"~     This is a randomised, double-blind, placebo-controlled multiple dose study designed to~     explore the safety, tolerability and PK of DS-1971a following oral administration over 14~     days to healthy male subjects.~   "
105716|NCT02183649|"~     The primary objective of this trial was to investigate the potential effects of pentoxyverine~     on the ECGs of healthy subjects. A secondary objective was the exploration of safety and~     tolerability. Pharmacokinetics (PK) were only to be investigated if necessary for the~     explanation of ECG effects.~   "
105196|NCT02190435|"~     There are approximately 250,000 hip fractures in the US every year, and intertrochanteric~     (IT) fractures (fractures that occur just below the femoral head) account for nearly half of~     these fractures. The use of intramedullary (IM) nails for fixation of IT femur fractures has~     become a well-accepted and increasingly more common procedure among orthopaedic~     traumatologists, and is standard of care at our institution.~      While advancements in intramedullary nail fixation have made it a relatively efficient~     procedure, the placement of the lag screw into the femoral head still remains a challenging~     step in the procedure. Inaccurate placement can lead to screw cut-out, one of the most~     commonly reported complications with IM nail fixation. Previous work has shown that the lag~     screw position is an important factor in reducing screw cut-out. This step of the procedure~     can be time demanding and often requires several intraoperative radiographs for accurate~     placement. Recently developed computer-assisted navigation systems provide surgeons with the~     ability to track screw placement in real-time. This could allow for improved screw placement~     and potentially reduce radiation exposure to the patient and surgeon. To date, the potential~     advantages of computer-assisted navigation have not been examined.~      The primary objective of this study is to examine whether the use of Stryker's ADAPT~     computer-assisted navigation for Gamma nail fixation can result in improved lag screw~     placement. The secondary objective is to examine whether the use of the ADAPT for Gamma nail~     fixation can reduce intraoperative radiation exposure.Our hypothesis is that there is a~     difference in the lag screw placement (i.e. tip to apex distance measurement) between~     procedures using the ADAPT system versus the conventional technique for Gamma nail fixation.~     Additionally, we hypothesize that there is a difference in radiation exposure (i.e.~     fluoroscopy time) between procedures using the ADAPT system versus the conventional technique~     for Gamma nail fixation.~   "
105197|NCT02190422|"~     Assisted reproductive technology (ART) has extensively allowed pregnancy for infertile~     couples. However, the long-term effect of ART exposure on cardiovascular development and~     potential association with ART procedure and parental factors is confused. The aim is to shed~     more light on the pattern and extent of cardiovascular developmental alteration among ART~     children and its association with potential confounders.~   "
105198|NCT02190409|"~     The purpose of this study was to evaluate the effects of (Platelet Rich Fibrin) PRF~     application on implant osseointegration in the early phase of healing.~   "
105199|NCT02190396|"~     Maternal vitamin D deficiency has been suggested to influence fetal and neonatal health. The~     role of placenta in vitamin D regulation is known but alteration of Vitamin D levels at~     placental pathologies is unknown. Placental calcification is usually thought to be a~     physiological aging process. Nevertheless, it can be a pathological change resulting from the~     effects of environmental factors on the placenta. The aim of the investigators study was to~     evaluate the relationship between placental calcification and maternal and cord blood~     25-hydroxyvitamin-D3 [25(OH)D] and calcium concentrations in low-risk obstetric population at~     term and their consequences.~   "
105200|NCT02190383|"~     The main purpose of this study is to evaluate the efficacy of a habit reversal based~     treatment programme in children and adolescents aged 8 to 18 years with tic disorders.~   "
105201|NCT02190370|"~     The main purpose of this study is to evaluate the efficacy of a resources activation based~     treatment programme in children and adolescents aged 8 to 18 years with tic disorders.~   "
105202|NCT02190357|"~     Cirrhotic patients are predisposed to intestinal dysmotility, bacterial overgrowth, and~     increased intestinal permeability all leading to an increase in bacterial translocation and~     increased endotoxemia. Rifaximin is an antibiotic that is virtually non-absorbed after oral~     administration and exhibits broad spectrum antimicrobial activity against both aerobic and~     anaerobic gram-positive and gram-negative microorganisms within the gastrointestinal tract.~     It has been suggested that oral prophylactic antibiotics or bowel decontamination might~     improve long-term outcomes in patients with cirrhosis. The aim of this study was to explore~     the effect of rifaximin on the complications of advanced cirrhosis.~   "
105203|NCT02190344|"~     The objective of this study is to determine the functionality of an eight-channel paddle coil~     system which is to be used in future MRI studies.~   "
105204|NCT02190331|"~     -  To evaluate the effects of a 32-weeks resistance and stretching training program applied~          in Physical Education classes on forward head and protracted shoulder Portuguese~          adolescents (15-17 years old).~        -  To evaluate on adolescents submitted to strength and stretching exercises the effects of~          a 16-week detraining period after the end of the intervention protocol.~   "
105205|NCT02190318|"~     Aldosterone blockade is useful in preserving residual renal function in patients on PD.The~     long term efficacy of dual blockade of the RAAS is better than monotherapy.~   "
105206|NCT02190305|"~     The purpose of this study is to determine the efficacy of two rapid diagnostic tests in~     plasma, venipuncture whole blood, and fingerstick whole blood. The clinical performance of~     Multiplo HBc/HIV/HCV will be determined by comparing the results with patient infected status~     for HIV-1/2 (human immunodeficiency viruses 1 and 2), HBV (hepatitis B virus) and HCV~     (hepatitis C virus). The clinical performance of Reveal HBsAg will be determined by comparing~     the results with patient infected status for HBV.~      Subject participation in the study will consist of a single one-hour visit, at which time~     blood samples will be drawn for testing with the investigational devices and with approved~     comparator assays. The test results, which are the outcome of the study, will be obtained~     only once, at the time of this visit.~   "
105207|NCT02190292|"~     Background: Obsessive-compulsive disorder (OCD) is considered one of the most debilitating of~     the psychiatric illnesses, yet much remains unclear regarding causes and cures. A diagnostic~     subgroup with acute onset of obsessive-compulsive symptoms (and sometimes tics or anorexia~     nervosa) possibly due to an autoimmune response, has been entitled Pediatric Acute onset~     Neuropsychiatric Syndrome (PANS). PANS is sometimes treated with immunomodulatory therapy or~     antibiotics, with a variable outcome. A diagnosis of PANS is supported by elevated levels of~     auto-antibodies and antibody-enzyme activity measured with the Cunningham panel, but the~     relationship between these biomarkers and the patients' symptoms remains unclear. A clinician~     rated symptom scale for PANS (the PANS scale) has been developed, but needs to be further~     evaluated regarding sensitivity and specificity.~      Aims:~        -  To assess a Swedish cohort of patients diagnosed with PANS and compile their psychiatric~          health status, biomarkers, psychiatric symptoms, soft neurological signs and treatment~          outcomes in a systematic way~        -  To compare psychiatric health status, biomarkers and psychiatric, neurologic and motor~          symptoms in this PANS cohort with a control group of psychiatric patients and with~          healthy children.~        -  To evaluate the Cunningham panel as a diagnostic tool for PANS.~        -  To evaluate a clinician rated symptom scale (the PANS scale) as a diagnostic tool for~          PANS.~      Method: Observational study Participants: Patients (n≈150) who have been tested with the~     Cunningham panel of PANS biomarkers in Sweden (or Swedish patients tested in Denmark) will be~     asked to participate.~      Procedure: Assessment of current symptoms, psychiatric health, neurological and motor~     symptoms and possible biomarkers for PANS will be collected for all patients. Retrospective~     assessment through interview and medical records, including results from the first assessment~     with the Cunningham panel of PANS-biomarkers is made with all patients. 50 out of the total~     PANS cohort of 150 patients will be re-tested with the Cunningham panel. A control group~     consisting of psychiatric patients (n=60) and healthy children (n=25) will be examined with a~     similar test battery and signs and symptoms will be compared with the PANS group.~      Significance:~      Previous and current symptoms of PANS, levels of PANS biomarkers and treatment outcome will~     be investigated, thus knowledge regarding long-term outcome and evidence for the use of~     clinical assessment tools and biomarkers for diagnosing PANS will be gained.~   "
105251|NCT02189720|"~     The primary objective of the study is:~      • To provide patients with LEMS/CMS/downbeat nystagmus access to amifampridine phosphate~     therapy until the product becomes commercially available.~      The secondary objective of the study is:~      • To assess the long-term safety of amifampridine phosphate in patients with~     LEMS/CMS/downbeat nystagmus~   "
105208|NCT02190279|"~     Background:~      - Prostate cancer is the second leading cause of cancer deaths in American men. A chemical~     called a radiotracer helps doctors get images of this type of cancer. Researchers want to~     test a radiotracer called 18F-DCFBC.~      Objective:~      - To see if the radiotracer 18F-DCFBC can identify sites of prostate cancer in the body.~      Eligibility:~      - Men ages 18 and over with prostate cancer. The cancer must be newly diagnosed, have~     relapsed, or has spread outside the prostate.~      Design:~        -  Participants will be screened with physical exam and medical history. They will give a~          blood sample.~        -  Participants will be divided into three groups.~      Group 1: people with cancer only in the prostate scheduled for surgical prostate removal or~     biopsy at NIH.~      Group 2: people who had their prostate removed or had radiation therapy and now have a rising~     prostate-specific antigen (PSA) without other signs of disease.~      Group 3: people whose cancer has spread to other areas of the body.~        -  Participants will have 18F-DCFBC injected into a vein then imaged in a PET/CT camera.~          During the scans, they will lie on their back on the scanner table.~        -  Group 1 will have a magnetic resonance imaging (MRI) scan. A tube will be placed in the~          rectum. Coils may be wrapped around the outside of the pelvis. Participants will have a~          contrast agent injected through an intravenous line.~        -  Group 3 will have another PET/CT scan with a different radiotracer, 18F NaF, within 21~          days of the 18F-DCFBC scan to look for prostate cancer in the bone.~        -  Group 3 will repeat the two PET/CT scans 4-6 months after the initial scans.~        -  A few days after each scan, participants will be contacted for follow-up.~   "
105209|NCT02190266|"~     Background:~      - Coccidioidomycosis is caused by a fungus that grows in the southwest United States and~     parts of Mexico and South America. This disease is caused by breathing dust containing the~     fungus. It can lead to serious lung and breathing problems. Rarely, the fungus can infect~     other body parts. This is called disseminated coccidioidomycosis (DCM). If the fungus stays~     in the lungs for more than 6 months, it is called refractory coccidioidomycosis (RCM). People~     with DCM or RCM may have difficulty fighting off infection because of immune system problems.~     Researchers want to study the immune systems of people with DCM or RCM, to learn more about~     the disease and the best ways to treat it. They also want to learn more about the types of~     people that get DCM or RCM and about the fungus that causes it.~      Objectives:~      - To learn more about DCM and RCM, the fungus that causes these diseases, and the people who~     get them.~      Eligibility:~      - People over age 2 with DCM or RCM.~      Design:~        -  Participants will be screened with a review of their medical records.~        -  At the initial visit, participants will have:~        -  Medical history and physical exam~        -  Blood and urine tests. Some blood may be used for genetic testing. The samples will not~          include participants names. Participants will be notified only if the tests show~          something urgent about their DCM/RCM. Researchers think this sort of problem will be~          rare.~        -  Questionnaire about their DCM/RCM~        -  Sputum (mucus) collection. They will spit into a cup.~        -  Participants will have 1 follow-up visit per year for up to 5 years. They will have~          blood tests. They may have other procedures to treat their DCM/RCM.~   "
105210|NCT02190253|"~     Background:~      - The hepatitis E virus causes an acute hepatitis that usually goes away by itself.~     Researchers in France studied people who received a liver or kidney transplant. They found~     that hepatitis E may not go away by itself in these people. It becomes chronic. This can~     cause serious liver disease. More than half the people who had organ transplant who had~     hepatitis E seemed to get a chronic infection.~      Researchers want to find out if hepatitis E happens this often in patients who have liver,~     kidney, or small bowel transplants in the United States. If it does, they want to know why.~     They want to know if chronic hepatitis E will become an important medical problem. This~     research might help improve care for people who have a transplant. It also might help~     researchers prevent the spread of hepatitis E.~      Objective:~      - To see how many patients who have received or are waiting for certain transplants have~     antibodies to hepatitis E virus.~      Eligibility:~      - Adults over age 18 who have had a liver, kidney, liver and kidney, or small bowel~     transplant, or are on a waiting list for one.~      Design:~        -  Participants will be enrolled from 3 transplant centers.~        -  Participants will complete a questionnaire. They will be asked about possible risk~          factors for hepatitis E exposure.~        -  Participants will have a blood sample drawn through a needle placed in a vein.~   "
105211|NCT02190240|"~     The proposed study has 3 aims: 1) quantitatively describe a model for delivering~     complementary and alternative medicine (CAM) therapies to understand the selection of~     patients and CAM therapies used for pain management, 2) examine the effects of selected CAM~     therapies on immediate change in pain, and 3) examine the effects of selected CAM therapies~     on duration of pain change.~      Positive results from this study will assist hospitals in the integration of usual care and~     CAM therapy for pain reduction. Findings may also drive future research on the cost~     effectiveness of these therapies for pain management, as well as the impact on patient~     outcomes such as length of stay and use of narcotics.~   "
105212|NCT02190227|"~     The purpose of this study is to determine the optimal time to use the Tumor RNA Disruption~     Assay (RDA) as a predictor of pathological complete response (pCR) in patients with breast~     cancer treated with neoadjuvant chemotherapy.~      This is important because the earlier non-responders are identified, the greater is the~     impact of reducing side effects of ineffective treatments.~      The study hypothesis is that the RDA score will accurately predict for tumor response after~     one cycle of chemotherapy.~   "
105213|NCT02190214|"~     This will be a population based study looking at the prevalence of thyroid disorders in~     Malaysia (including hypo- and hyperthyroidism, subclinical hypo- or hyperthyroidism) and its~     association with different ethnicity and iodine status. The study will also look at genetic~     susceptibility for autoimmune thyroid disorders in the Malaysian population~      General hypotheses:~      The prevalence of thyroid disorders in Malaysia is 10% for hypothyroidism and 2% for~     hyperthyroidism Hypo- and hyperthyroidism is associated with iodine status in our population~     There are different susceptibility gene for autoimmune thyroid disorder in different~     ethnicity in our population~   "
105214|NCT02190201|"~     The investigators previous study showed that McGrath Series 5 videolaryngoscope is an~     alternative tool for double-lumen tube intubation. But it is not determined about the~     advantages and disadvantages of McGrath Series 5 videolaryngoscope for double-lumen tube~     intubation, compared with traditional Macintosh laryngoscope.~   "
105215|NCT02190188|"~     Research on the implications of orthotic devices and the recovery after knee arthroscopy are~     widely known. But only a handful of specific issues have been studied to date. However, the~     effect of orthotic devices on the recovery after partial meniscectomy are largely unknown. To~     our best knowledge, there are no studies that deal with the treatment of partial medial or~     lateral meniscectomy with wedge insoles, valgus or varus knee braces. The purpose of this~     study is to find out if using wedge inserts or knee orthoses improve the outcomes after~     partial meniscectomy.~      We therefore verify the following hypothesis: In patients with partial meniscectomy can be by~     the postoperative use of exculpatory wedge deposits or relieving knee brace achieve a~     significantly better clinical outcome than without specific treatment.~   "
105216|NCT02190175|"~     This is a multicentre non interventional observational study with the objective to follow up~     patients with atrial fibrillation who based on current indications are treated with per os~     flecainide , for cardiac pulse maintenance.~   "
105217|NCT02190162|"~     The purpose of this study is to assess the effects of Tantum Verde® for improving recovery~     following tonsillectomy Study design: A prospective double-blined randomized trial. Sample~     size: Thirty patients undergoing tonsillectomy who will be treated with Tantum Verde® Mouth~     wash solution, and a control group of 30 patients that will undergo tonsillectomy and will be~     treated with a placebo.~      The study will be conducted in the Departments Otolaryngology - Head and Neck Surgery in the~     Western Galilee Medical Center, Nahariya, Israel. Patients who are scheduled for~     tonsillectomy with or without adenoidectomy will be recruited for the study. They will sign~     the inform consent in one of two places: in the departments before the surgery or in the~     clinic in the visit before the surgery. The patients will be evaluated for their ability to~     gargle and spit water before the surgery, after which they will be assigned to either the~     treatment group who will get a solution of Tantum Verde or the control group who will receive~     saline with mint flavor, both in identicle bottles. Randomization will be done using a random~     number generator program.~      The patients will be asked to gargle and spit the solution they received three times a day~     for 30 seconds, for the following week after surgery.~   "
105218|NCT02190149|"~     This 6-month prospective outcomes study addresses the association between timing of infusion,~     patient activity levels, and bleeding episodes through patient-reported measurements.~   "
105219|NCT02190136|"~     Stretching and flexibility exercise such as yoga and functional resistance exercise are two~     forms of exercise that are growing in popularity. However, they have not been scientifically~     tested to demonstrate their ability to improve body composition, fitness, heart and metabolic~     health, and mood state in overweight/obese women. The investigators hypothesize that during~     an 11 week intervention, both forms of exercise will improve body composition, heart and~     metabolic health and mood state.~   "
105220|NCT02190123|"~     REWINDER is a multinational, multicentre, non-interventional, retrospective study of patients~     treated with an oral antiplatelet (ticagrelor, prasugrel or clopidogrel) while in hospital~     after an acute coronary syndrome (ACS) event, to be conducted in Belgium and Luxembourg.~      Primary objective is to evaluate the actual treatment persistence with oral antiplatelets~     (OAP) after an ACS in the clinical practice in Belgium and Luxembourg.~      The main secondary objectives are to describe the most frequent reasons for OAP treatment~     switch, discontinuation or reinitiation; to identify the decisionmakers in the OAP treatment~     changes and to characterize the patient profile in terms of demographics, diagnosis,~     management strategies, comorbidities and concomitant medications to identify any association~     between patient profile and treatment duration.~   "
105221|NCT02190110|"~     Pulmonary embolism (PE) should be suspected in patients with dyspnea, chest pain, syncope,~     shock/hypotension, or cardiac arrest. Discriminating patients in different categories of~     pre-test probability of PE has become a key step in all diagnostic algorithms for PE. The~     most frequently used clinical prediction rule is the Wells score (PE likely > 4 points and~     PE unlikely ≤ 4 points). PE can be safely ruled out in patients with a PE unlikely~     associated with a negative d-dimer test result. Conversely, patients with PE likely or~     positive d-dimer level should undergo further diagnostic testing, like multidetector computed~     tomography pulmonary angiography (MCTPA).~      Wells score accuracy is not optimal. Vein and lung US can be rapidly performed at bedside as~     an extension of physical examination and have a high specificity. The aim of this study is to~     evaluate if the combination of clinical data reported in the Wells score and US data obtained~     from vein and lung US (US Wells score) has a better diagnostic accuracy compared to~     traditional Wells score.~      In adult patients suspected of PE traditional Wells score will be calculated and vein and~     lung US (multiorgan US) will be performed in all patients and and US Wells score calculated.~     The US Wells score differs from the traditional Wells score in the following items: signs~     and symptoms of DVT, replaced by vein US showing DVT, and alternative diagnosis less~     likely than PE replaced by alternative diagnosis less likely than PE after multiorgan US.~     This latter item is considered positive if at least one subpleural infarct is detected at~     lung US, and negative if no subpleural infarcts are detected and an alternative diagnosis~     like pneumonia, pleural effusion or diffuse interstitial syndrome may explain the symptoms of~     presentation. If no findings are detected at lung US, the points for the item remain the same~     assigned by traditional Wells score. Final diagnosis of PE will be preferentially established~     by MCTPA and in patients discharged without a second level imaging test because of negative~     Wells or d-dimer, and patients with not conclusive second level diagnostic test, will enter~     the 3 months follow-up protocol.~      The diagnostic performance of traditional and US Wells scores will be assessed by calculating~     sensitivity, specificity, positive, and negative predictive value, and likelihood ratios.~     Failure rate and efficacy of d-dimer in patients stratified as PE likely and PE unlikely~     will also be calculated.~   "
105222|NCT02190097|"~     Polycystic ovary syndrome (PCOS) is a syndrome which includes elevated androgen levels,~     irregular menstrual cycles and insulin resistance. Standard treatments, which include weight~     loss and medications to improve insulin secretion are only partly successful, and may require~     that young women take medications for decades.~      The study investigators have been evaluating the effects of specific diets on insulin~     resistance in healthy volunteers and subjects with type 2 diabetes, and have found that~     subjects with insulin resistance seem to respond particularly well to these diet regimens.~      Volunteers with PCOS are being asked to participate to see if following these diets can help~     regularize your menstrual cycles. The results of this study may help improve fertility~     treatments for women with PCOS.~   "
105223|NCT02190084|"~     Alzheimer's Dementia (AD) is a major public health problem. Apathy, a profound loss of~     motivation, is seen in majority of patients with AD. Dysfunction of the front of the brain~     and loss of dopamine, a type of neurochemical, in this part of brain results in apathy.~     Presence of apathy is linked to deficits in planning sequential tasks such as keeping a~     routine. Patients with apathy have poor physical function and their caregivers experience~     extra burden. Unfortunately there are no good medications to treat apathy. FDA has approved~     the use of brain stimulation by a magnet known as repetitive transcranial magnetic~     stimulation (rTMS), for treatment of depression. rTMS increases dopamine when applied to~     frontal lobe of brain so we propose that rTMS would be a good treatment option for apathy in~     AD. Study hypotheses include that rTMS to the dorsolateral prefrontal cortex (DLPFC) will~     improve apathy and executive function better than sham treatment in those with AD.~   "
105226|NCT02190045|"~     Falls are a major public health problem. They are the leading cause of injuries and~     injury-related deaths in those aged over 65 years. Balance and gait abnormalities are major~     reasons for falls in elderly. Exercise interventions improve gait and balance in the elderly.~     Despite the many proven benefits of exercise, many older adults in the US remain sedentary.~     This study targets at improving balance and gait with use of Wii-Fit as an exercise program.~   "
105227|NCT02190032|"~     The investigators are trying to compare the individually modified-angled tube and the~     conventional-angled tube in ease of double lumen endotracheal tube insertion and the~     incidence of related postoperative complications.~   "
105228|NCT02190019|"~     Mild cognitive impairment (MCI) is a precursor of dementia. Apathy, a profound loss of~     motivation, is a common behavioral problem in MCI. Presence of apathy may increase the chance~     of MCI patients converting to Alzheimer's Dementia. Repetitive Transcranial Magnetic~     Stimulation (rTMS), a non-invasive tool, has been recently approved for treatment of~     refractory depression. Since dysfunction in the frontal lobe of the brain is seen in patients~     with apathy, rTMS to the frontal lobe might be helpful in treating the same. Study hypotheses~     include that rTMS to the dorsolateral prefrontal cortex (DLPFC) will improve apathy and~     executive function better than sham treatment in those with MCI~   "
105229|NCT02190006|"~     Our study is observational, we are observing data from routine measurements during IVF/ICSI.~     Our study does not assess IVF/ICSI as an intervention, we are evaluating the role of FSI and~     preovulatory count which are calculated by observing routine measurements during the IVF/ICSI~     procedure.~      300 women with polycystic ovarian syndrome (PCOS) who are decided to be treated with ICSI.~     will be subjected to full history taking and clinical examination. On the second day of~     menstruation serum FSH, LH, Prolactin and Oestradiol will be assessed and the antral~     follicular count (AFC) will be assessed using a vaginal ultrasound scan. AFC will be defined~     as the number of follicles measuring 3-10mm.~      All patients will have standard pituitary down-regulation followed by follicle stimulating~     hormone (FSH) stimulation until the day of Human chorionic gonadotrophin (HCG)~     administration.~      On the day of HCG administration, ovarian ultrasound scan will be performed using a~     transvaginal probe and the Preovulatory follicle count (PC) will be assessed, (PFC) is~     defined as number of follicles measuring≥16mm. Follicular output rate (FORT) will be~     calculated as: (FSI =PFC*10000/AFC*Total dose of FSH).~      FORT correlation to pregnancy will be compared to that of the preovulatory count number~   "
105230|NCT02189993|"~     The purpose of this study is to determine what the long term survival is after in hospital~     use of total parenteral nutrition due to intestinal failure.~      Earlier studies only followed patients for a maximum of 6 months or included only very~     specific patients. We were interested in all patients in our hospital and followed them for~     up to 2 years.~   "
105231|NCT02189980|"~     The purpose of this follow up study is to determine the duration of action regarding~     aromatherapy to treat nausea occurring postoperatively.~   "
105232|NCT02189967|"~     In this randomized multicentric phase II study it will be investigated whether an accelerated~     postoperative radiotherapy with photons or protons (7 fractions per week, 2 Gy single dose)~     may improve locoregional tumour control in non-small cell lung cancer (NSCLC) in comparison~     to conventional fractionation (5 fractions per week, 2 Gy single dose).~   "
105233|NCT02189954|"~     Laryngeal Mask is widely used for air-way management during anaesthesia. Pharyngolaryngeal~     morbidity linked to laryngeal mask use is related to correct choice of mask size, placement~     technique, placement of the laryngeal mask in the correct position on the larynx, cuff volume~     and cuff pressure. It has been stated that keeping laryngeal mask cuff pressure below 45 mmHg~     (60 centimeter of water(cmH2O) ) can prevent pharyngolaryngeal morbidity related to laryngeal~     mask (throat pain, dysphonia, dysphagia) and shown that using a manometer after Laryngeal~     Mask Unique placement to limit pressure within the cuff can reduce this morbidity by nearly~     70%. Studies commenting on pharyngolaryngeal morbidity generally do not choose a certain age~     group and cover stages including very young and middle-aged groups. In the literature only~     one similar study on the geriatric age group was found.~      The aim of this study is to compare the postoperative pharyngolaryngeal morbidity in a group~     with cuff pressure held to 44 mmHg (60 cmH2O with a manometer and a group with Laryngeal Mask~     cuff inflated without reference to pressure in the geriatric age group with indications for~     Laryngeal Mask Unique placement.~   "
105234|NCT02189941|"~     The purpose of this study was to evaluate the pharmacokinetic and safety profile of the~     sustained-release formulation of deferiprone under both fasting and fed conditions, and~     evaluate the relative bioavailability of this sustained-release formulation when compared to~     immediate-release formulation of deferiprone under fasting conditions.~   "
105235|NCT02189928|"~     Cerebral infarction is the most common form of stroke (80% of strokes). Stroke is the first~     cause of acquired disability, and the 2nd cause of dementia and death. The only approved~     treatment in the first 4.5 hour is intravenous rt-PA thrombolysis (Actilyse ®) whose~     objective is recanalization of occluded artery and reperfusion of the brain parenchyma. Few~     patients are treated (1-5%) and they keep disability in 50-60% of cases. This handicap is~     mainly correlated to the final infarct size. The objective of neuroprotective treatments is~     to reduce the final size of the cerebral infarction.~      The per-conditioning remote ischemic (Per-CID) showed a neuroprotective effect in cerebral~     ischemia by reducing the final size of cerebral infarction animal models. The per-CID~     corresponds, in cases of cerebral ischemia, to iterative ischemia realization of a member~     with a cuff. In humans, the per-CID has shown a cardioprotective effect in a randomized~     control trial involving 250 patients within 6 first hours of myocardial infarction and~     candidate for primary angioplasty.~   "
105252|NCT02189707|"~     To determine if Bifidobacterium lactis HN109 improves transit time and gastrointestinal~     symptoms in adults with constipation.~   "
105322|NCT02188797|"~     The goal of this study is to evaluate a group-based motivational interviewing (MI)-delivered~     risk reduction program for homeless young adults. It is hypothesized that youth who~     participate in the program will show greater reductions in substance use intentions, behavior~     and consequences, as well as sexual activity intentions and risk behavior, over a 3-month~     period compared to a usual care control sample of youth who do not participate in the~     program.~   "
113239|NCT02085239|"~     This study will evaluate the potential role of a long acting anesthetic (ropivacaine) in~     providing an extended period of pain relief for patients undergoing ultrasound guided core~     biopsy of the breast.~   "
105236|NCT02189915|"~     Study Purposes and Objectives:~      The objectives should be stated in such a way that the reader can determine the~     appropriateness of the study design. If appropriate, state the specific hypotheses being~     tested and/or study aims. Use lay language.~      Methamphetamine use is of great concern in the state of Utah because it's the primary drug of~     threat in the state, and is the primary drug of choice among females between the ages of 18~     and 24. The primary hypothesis of the study is that eight weeks of oral creatine~     supplementation will result in improvements in depression rating scores in female MA users.~     Secondary hypotheses include the following: 1) creatine supplementation will result in a~     decrease in the number of positive MA screens; 2) NAA and Cr concentrations will increase~     after eight weeks of oral creatine supplementation; and 3) PCr/β-NTP levels in the frontal~     lobe using 31P MRS will increase after eight weeks of creatine monohydrate oral~     supplementation.~   "
105237|NCT02189902|"~     The goal is to determine the vit D supplementation dose that safely results in optimal serum~     vitamin D (25D) concentrations in HIV-infected children and adults living in Botswana. To do~     this the investigators will test two oral daily doses (4000 vs. 7000 IU) of cholecalciferol~     (D3) dietary supplement over a 12-week period in 60 children and adults with HIV/AIDS living~     in Botswana (5.0 to 50.9 yrs), to assess safety as determined by serum calcium and 25D~     concentrations and efficacy to replete vit D status as determined by achieving a minimum~     serum 25D concentration of 32 ng/mL (80 nmol/L).~   "
105238|NCT02189889|"~     Anemia which is a decreased blood count or lower than normal hemoglobin (hgb), is a major~     health problem for patients having heart surgery. Hemoglobin is the part of our blood that~     carries oxygen from the lungs to the rest of the body. Anemia that is present before surgery,~     called preoperative anemia, is a risk factor for an increased chance of morbidity (illness)~     and/or mortality (death) after heart surgery. It is also an important indicator of blood~     transfusion necessity. Recent clinical research investigations done to study preoperative~     anemia suggest a blood transfusion can damage the immune system (the system that protects us~     from disease) which can lead to infection, organ dysfunction (especially of the heart,~     kidney, brain), prolonged hospital stays, as well as increased supplies, resources and cost~     in surgical patients. Comprehensive anemia management can reduce or eliminate the need for~     blood transfusions and provide better outcomes after surgery. Therefore, controlling anemia~     before surgery is extremely important, and could be a lifesaving measure.~      This pilot, feasibility study is being done for several reasons. First of all, it will test~     the the safety and effectiveness of using a short-course of two medications, erythropoietin~     (EPO) and Feraheme (iron given intravenously [IV]), to increase hemoglobin levels in order to~     improve preoperative anemia, reduce transfusions and lower postoperative complications in~     anemic patients undergoing heart surgery. Secondly, findings will be used to design a large~     randomized controlled trial (RCT). The RCT will establish a protocol to actively manage~     anemia before surgery, thus reducing transfusions during surgery and improving recovery~     afterwards. It will also help identify valuable information regarding what needs to be done~     for timely completion of the planned RCT.~      EPO is a medication approved by the Food and Drug Administration (FDA) used to treat anemia~     in patients with certain conditions in order to reduce blood transfusions. And although~     approved for use during surgery, it has not been FDA approved for use in cardiac (heart) or~     vascular (blood vessels, including veins and arteries) surgery. Common side effects include~     nausea, vomiting, itching, headache, injection site pain, chills, deep vein thrombosis (blood~     clot), cough, and changes in blood pressure (BP). Feraheme is an iron replacement product~     approved for the treatment of low iron anemia in adult patients. It may cause serious~     allergic reactions, including anaphylaxis (severe, whole body allergic reaction), as well as~     low BP and excessive iron storage.~      Patients meeting all eligibility requirements that consent to participate will be randomized~     into the study. Randomization is being placed by chance (like a flip of a coin) into one of~     two study groups, the treatment group or the control group. There is an equal chance of being~     placed into either group, which will be done by a computer.~        1. The Treatment Group will receive a 300 unit (U) per kilogram (kg) injection of EPO and a~          510 milligram (mg) IV infusion of Feraheme 7-28 days before the day of surgery. And~          again 1-7 days before the day of surgery, a second dose of both of these medications~          will be given. The third dose, of EPO only, will be administered 2 days after surgery.~          Before initiating a dose or giving a subsequent dose, laboratory parameters will be~          measured to assess the hemoglobin level and response to the medication. If blood values~          increase too rapidly or are too high, the meds will not be started or, if already dosed,~          they will not be given again.~        2. The Control Group will receive no preoperative intervention for anemia unless lab~          results show iron deficiency anemia. The control group will be screened for the presence~          of iron deficiency anemia by evaluating blood laboratory values drawn during the~          baseline or preoperative visit. If lab results indicate iron deficiency anemia,~          over-the-counter oral iron will be recommended, to take until the day of surgery. In~          doing so, patients may benefit by potentially reducing the need for blood transfusions.~      Data will be collected from all participants from the preoperative visits throughout the~     admission, including lab results, medications, vital signs, information about the procedure,~     transfusions, and any problems or adverse events.~   "
105239|NCT02189876|"~     The FemAALES Project is a community collaborative two-arm intervention designed to prevent~     HIV (human immunodeficiency) and STD (sexually transmitted disease) infection and~     transmission among African American women and men by reducing sexual risk factors and~     enhancing sexual negotiation skills. The team of investigators is a collaboration of~     researchers and community service providers who are committed to developing prevention~     interventions that employ holistic and culturally relevant approaches. This includes~     recognizing the impact of forces such as racism, sexism, and gender expectations on~     individual behavior and relationship dynamics in African American communities. Specifically,~     the investigators hypothesis is that compared to the control condition the FemAALES~     intervention arm will reduce risky sexual behavior and STI (sexually transmitted infection)~     incidence and will increase condom self-efficacy and risk behavior communication with sexual~     partners.~   "
105240|NCT02189863|"~     The overall objective of this study is to compare the effect on simulated driving performance~     of multifocal (MF) versus monovision (MV) soft contact lenses in mid-late presbyopes.~   "
105241|NCT02189850|"~     The purpose o this study is to evaluate the safety, tolerance and efficacy of BLI800 as a~     bowel preparation prior to colonoscopy in pediatric patients.~   "
105242|NCT02189837|"~     This is a randomized, double-blind, placebo-controlled trial to evaluate the effect of~     evolocumab, atorvastatin, and combination therapy on lipoprotein kinetics.~   "
105243|NCT02189824|"~     A phase 1 study of infusion of partially HLA matched unrelated donor blood or marrow cells~     (microtransplantation) following consolidation chemotherapy in patients with AML that are not~     suitable for allogenic stem cell transplantation.~   "
105244|NCT02189811|"~     Poliomyelitis eradication has entered its last phase with only three remaining endemic~     countries, of which Pakistan is one. There hasn't been a case of wild type poliovirus 2 since~     1999, and no case of wild type poliovirus 3 since November 2012. However, paralytic polio~     resulting from circulating strains of Sabin poliovirus type 2 have become a challenge, and~     reported from several areas with low population immunity to polio, including in Pakistan.~     This study will provide data to National Immunization Authorities in order to make strategic~     decisions about their polio vaccination schedules in anticipation of the global tOPV to bOPV~     switch and will provide data on the proposed responses to type 2 poliovirus outbreaks.~   "
105245|NCT02189798|"~     The purpose of this feasibility study is to evaluate whether low-frequency acoustic hearing~     sensitivity can be preserved in newly implanted adults with partial deafness (considerable~     low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural~     hearing loss) using the HiResolution™ 90K™ Advantage cochlear implant with the HiFocus™~     Mid-Scala electrode to support the development of electro-acoustic stimulation technology~     (EAS).~   "
105246|NCT02189785|"~     This project hypothesizes that the brain's opioid system determines rejection sensitivity, a~     personality trait that is a vulnerability factor and feature of several psychiatric~     disorders. This project will use positron emission tomography to measure the brain's opioid~     response to social rejection and acceptance in a nonclinical population with varying levels~     of rejection sensitivity. The results will provide the first major step towards understanding~     a neurotransmitter mechanism for rejection sensitivity, allowing for further investigation~     into predicting and treating its associated disorders.~   "
105247|NCT02189772|"~     The purpose of this study is to evaluate the safety and tolerability of a single~     administration of Metadoxine Extended Release (MDX) formulation for the treatment of~     adolescents diagnosed with ADHD that have predominantly inattentive symptoms. The study will~     also try to evaluate the efficacy of MDX and its level in the blood.~   "
105248|NCT02189759|"~     The overall hypothesis is that better adherence to Kangaroo Mother Care (KMC) in combination~     with existing WHO thermoregulation care will reduce the incidence of moderate hypothermia~     (32-36 degrees C) or severe hypothermia (<32.0 degrees C) in term infants (greater than or~     equal to 37 weeks of gestational age) when compared with routine WHO thermoregulation alone.~   "
105249|NCT02189746|"~     The overall hypothesis is that better adherence to Kangaroo Mother Care (KMC) in combination~     with existing WHO thermoregulation care will reduce the incidence of moderate hypothermia~     (32-36 degrees C) or severe hypothermia (<32.0 degrees C) in preterm infants (32-36 6/7 weeks~     of gestational age) when compared with routine WHO thermoregulation alone.~   "
105250|NCT02189733|"~     The primary objective of the study is to evaluate the pharmacokinetic characteristics and~     demonstrate bioequivalence of a reconstituted new lyophilized formulation of caplacizumab for~     subcutaneous (s.c.) injection as compared to an equal nominal s.c. dose of the reference~     liquid formulation of caplacizumab.~      The secondary objective of the study is to compare the safety and tolerability, and the~     pharmacodynamic parameters of the new formulation with those of the reference formulation.~   "
105368|NCT02188186|"~     Triple combination of metformin, DPP4 inhibitor and Thiazolidinedione would be a good option~     in the treatment of drug-naïve Korean type 2 diabetic patients.~   "
105253|NCT02189694|"~     Closed-loop strategy is composed of three components: glucose sensor to read glucose levels,~     insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required~     insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would~     regulate glucose levels through the infusion of two hormone: insulin and glucagon.~      The main objective of this project is to compare the efficacy of single-hormone closed-loop~     strategy, dual-hormone closed-loop strategy and pump therapy to regulate overnight glucose~     levels in children with type 1 diabetes in a diabetes camp.~      The investigators hypothesized that dual-hormone closed-loop strategy reduces the time spent~     in hypoglycemia in children with type 1 diabetes (T1D) compared to single-hormone closed-loop~     strategy, which in turn is more effective than the conventional pump therapy to reduce time~     spent in hypoglycemia~   "
105254|NCT02189681|"~     Spinal anesthesia is widely performed using a surface landmark based 'blind' technique.~     Multiple passes and attempts while administering spinal anesthesia are associated with a~     greater incidence of post dural-puncture headache, paraesthesia and spinal hematoma.~      Real time and pre-procedural neuraxial ultrasound techniques have been used to improve the~     success rate of spinal anesthesia. The use of real time ultrasound-guided spinal anesthesia~     has to date been limited to case series and case reports.Its use may be limited by the~     requirement for wide bore needles and the technical difficulties associated with simultaneous~     ultrasound scanning and needle advancement. The use of pre-procedural ultrasound has been~     shown to increase the first pass success rate for spinal anesthesia only in patients with~     difficult surface anatomic landmarks. No technique has been shown to improve the success rate~     of dural puncture when applied routinely to all patients. Routine use of pre-procedure~     ultrasound guided paramedian approach results in 50% reduction in number of passes required~     for spinal anaesthetic, from a study at Cork University Hospital (awaiting publication).~     L5-S1 is the widest interlaminar space and provides minimal contribution to overall movement~     of lumbar spine.This interspinous space might still be accessible even if the patient has~     minimal spine flexion. We also noted that spinal needle insertion via the L5-S1 interspace~     was associated with the fewest passes in the pre-procedure guided ultrasound group (although~     non-significant).~      We hypothesise that the routine use of pre-procedural ultrasound-guided paramedian spinal~     technique at L5S1 interspinous space will result in fewer needle passes to enter the~     subarachnoid space when compared to the conventional landmark based midline approach.~   "
105255|NCT02189668|"~     To determine if non-operative management with antibiotics alone is a feasible treatment~     alternative for pediatric patients with uncomplicated acute appendicitis with an~     appendicolith identified on imaging.~   "
105256|NCT02189655|"~     This prospective randomized double-blinded study was conducted to compare the antishivering~     effects of two different types of intrathecal administration.~   "
105257|NCT02189642|"~     The purpose of this study is to evaluate the quality of outcomes in the Post Anesthesia Care~     Unit (PACU) at BCH and to identify preoperative demographic and behavioral data as well as~     intraoperative and anesthetic predictors of adverse PACU outcomes. The investigators~     hypothesize quality of PACU outcomes will correlate with preoperative demographic and~     behavioral characteristics as well as intraoperative and anesthetic procedures/techniques.~     This study will help the investigators improve post anesthetic care quality and create a~     higher level of satisfaction for patients, family, and health care providers.~   "
105258|NCT02189629|"~     Multi-center, open-label, non-comparative safety and efficacy study with 52 Weeks of~     treatment on the face and trunk for acne vulgaris.~   "
105259|NCT02189616|"~     Asthma is the disease being studied. The main objective of this study is to assess the~     clinical efficacy of mobile phone short message service (SMS) reminder and consultation on~     the self-management and outcomes of poorly controlled asthma which is first diagnosed in a~     time period of 3 months. The secondary objective is to explore the cost-benefit and~     cost-effectiveness of the proposed intervention.~      Aims: The main aim of this study is to assist asthma patients to practice asthma~     self-management at home by sending reminders and responding to patients' consultations with~     mobile phone short message service (SMS), which will eventually help them to control their~     asthma, and prevent asthma exacerbation. Thus, the ultimate goal of this proposed study is to~     improve patient health outcome via enhancing patient-physician interaction through mobile~     phone short message service (SMS) that is low-cost and could be followed easily by the~     patients and their physicians.~      The hypothesis is that asthma patients who receive weekly text message reminders to educate~     them and reinforce adherence will have better asthma outcome, such as asthma control, while~     the intervention integrating patient consultation and reminders by SMS improve asthma outcome~     even more. The investigators further hypothesize that these subjects under intervention will~     have an improvement in secondary measures including quality of life and patient satisfaction.~     The investigators also anticipate that such an approach in asthma management will be~     cost-effective.~   "
105260|NCT02189603|"~     The purpose of this study is to determine the safety and immunogenicity of the recombinant~     hepatitis E vaccine in people older than 65 years, and evaluate the efficacy of hepatitis E~     vaccine in this population.~   "
105261|NCT02189590|"~     The purpose of this study is to determine if there is a difference in time for successful~     fiberoptic guided tracheal intubation through the i-gel or air-Q supraglottic airway.~   "
105262|NCT02189577|"~     The purpose of this study is to evaluate the efficacy and safety of CHF 5259 (glycopyrrolate~     bromide) for the treatment of COPD patients.~   "
105263|NCT02189564|"~     The effect of rewarding vs. non-rewarding feedback on acquisition of a motor skill is~     investigated in a single blinded parallel group design. Reward consists of performance~     dependent monetary reward, or of knowledge of performance in selected (above average) trials.~      The investigators hypothesize improved motor skill learning and higher involvement of the~     dopaminsrgic system under rewarding vs. non-rewarding conditions.~   "
105281|NCT02189330|"~     All subjects in this study will be given tafamidis. After swallowing a single pill of~     tafamidis, measurements including blood samples will be compared to see if tafamidis made in~     different ways is about the same. After approximately 28 days subjects will be given another~     pill of tafamidis and the study measurements will be repeated.~   "
105369|NCT02188173|"~     This is a study of OZURDEX® use in clinical practice in patients with diabetic macular edema~     (DME).~   "
105264|NCT02189551|"~     The objective of the study is to compare a new medical devices with an established medical~     device for lower limb rehabilitation regarding training outcome and patient comfort / patient~     satisfaction (primary objective) and treatment effect (exploratory objective).~      Primary study endpoints will be a significantly higher rated patient comfort and or patient~     satisfaction using the new versions, compared with the established Lokomat. Furthermore,~     muscle activity and kinematic movement patterns will be expected to show more involved muscle~     groups and a walking pattern involving more degrees of freedom during use of the new version~     compared with the established Lokomat.~      Exploratory endpoints will be a significantly stronger involvement of muscles needed for~     balance, more physiological walking patterns and more change on the lateral positioning of~     the feet due to training with the new version, compared with the established Lokomat.~   "
105265|NCT02189538|"~     Studies have shown that burn patients may benefit from low fat diets, but there is still no~     strong data regarding the impact of fatty acid composition used for feeding. The trial test~     the hypothesis that the inclusion of omega-3 PUFA in a low fat diet may improve outcome.~     Prospective randomised controlled trial in adult patients admitted for burns > 15% body~     surface area (BSA), and inhalation injury requiring mechanical ventilation and enteral~     nutrition. On admission randomization to receive a low-fat (18% energy as fat) modular~     enteral diet (LF-EN) and identical with the half of fat provided by fish oil (FO-EN). Study~     endpoints: mechanical ventilation time, inflammation (CRP), infectious and other~     complications, mortality until discharge.~      The study is planed as 2 parts: 1) preliminary study testing the feasibility of the study, 2)~     the study completed with information from the preliminary phase, both phases being randomised~     and controlled.~   "
105266|NCT02189525|"~     The purpose of this study is to evaluate blood-based biomarkers before and after~     sports-induced concussion using neuroimaging and head impact sensor technology.~   "
105267|NCT02189512|"~     The aim of this study is to study the impact of brain death and surgical small bowel~     manipulation on the release of different types of monocytes.~   "
105268|NCT02189499|"~     The purpose of this study is to evaluate the safety and feasibility of a new coronary artery~     stent for treating blockages in the arteries supplying blood to the heart muscle. The~     Amaranth FORTITUDE scaffold releases a drug (sirolimus) to reduce the likelihood of the~     treated blood vessel developing a new blockage. In addition, the scaffold dissolves away over~     time, leaving no permanent implant after the blood vessel has healed. This study will will be~     the first evaluation of this stent in humans.~   "
105269|NCT02189486|"~     Research repository designed to establish prostate cancer upgrading reference set and~     development of a risk prediction tool. Repository will include clinical information and~     biologics on a cohort of 240 men, to predict presence of high grade cancer at time of~     prostatectomy (removal of prostate) among patients with a low grade cancer diagnosis at time~     of biopsy.~   "
105270|NCT02189473|"~     The primary aim of this randomized multi-center trial is to investigate the efficacy of the~     radiotherapy regimens 5 x 4 Gy and 10 x 3 Gy with respect to the effect on motor function in~     patients with metastatic epidural spinal cord compression.~   "
105271|NCT02189460|"~     The purpose of this study is to understand the effect of age on language abilities. The~     investigators aim at investigating the cerebral modifications that take place in normal~     aging, at the functional an anatomical level.~   "
105272|NCT02189447|"~     Evaluation of the safety and efficacy of surface ablation followed by Collagen Cross-linking~     in patients with keratoconus~   "
105273|NCT02189434|"~     Serum procalcitonin levels will be considerably higher, for a longer period of time, in~     patients who develop sepsis compared to patients with SIRS or those who have an uncomplicated~     post-surgical recovery. Monitoring of serum procalcitonin trends will allow for an earlier~     diagnosis of, and initiation of treatment for, sepsis compared to current standard ICU~     methods.~   "
105274|NCT02189421|"~     The aim of this study is to evaluate the usefulness of a newly developed multibending~     ultra-slim upper endoscope for the successful direct peroral cholangioscopy (POC) without~     assisting accessory in comparison with conventional ultra-slim endoscope. The investigators~     expect that multibending endoscope will show more higher successful performance than~     conventional endoscope.~   "
105275|NCT02189408|"~     The purpose of this study is to investigate reduction of pain, gain of function and~     improvement of life quality by intraoperative applied platelet- rich- plasma ( PRP ) during~     knee arthroscopy for degeneration and osteoarthritis OA by conducting a randomized-~     controlled, double-blinded trial ( RCT ) including 58 patients with a follow up of 12 months~     and pain, assessed by Visual- Analogue Scale (VAS) after 6 months as primary endpoint.~   "
105276|NCT02189395|"~     The goal of the current study is to determine difference in glycemic control between~     traditional split mix regimen with Neutral Protamine Hagedorn (NPH) and regular insulin vs~     basal bolus regimen with glargine and humalog in a population of type 2 diabetes commonly~     encountered in the investigators county hospital setting which include newly diagnosed type 2~     patients and patients on relatively high dose of insulin (dose >0.4 units/kg body weight.~     Primary outcome of the study is to determine differences in glycemic control between~     treatment group as measured by the mean daily blood glucose. Secondary outcome is to measure~     number of hypoglycemic events, number of severe hypoglycemia and length of hospital stay.~   "
105277|NCT02189382|"~     This study will compare the safety and effectiveness of a potassium oxalate desensitizer or~     negative control on dentinal hypersensitivity.~   "
105278|NCT02189369|"~     This clinical validation study is being carried out to validate the efficacy of a test~     measuring the clinical application of prostaglandins present in the endometrial fluid in~     patients, 24 hours before the embryonic transfer. This test is capable of predicting~     endometrial receptivity without the need of performing a biopsy.~   "
105279|NCT02189356|"~     The aim of this study was to evaluate the effect of exercise programs on pregnant women with~     pregnancy-related Low Back and Pelvic Pain (LBPP). Hypotheses of the study were: 1) Exercise~     programs relieve the intensity of LBPP in pregnant women and 2) Exercise programs promote~     functional capacity for pregnant women with LBPP.~   "
105280|NCT02189343|"~     To determine the maximum tolerated dose (MTD), if present, and dose schedule of ACY-1215~     (ricolinostat) in combination with pomalidomide and low-dose dexamethasone in patients with~     relapsed-and-refractory multiple myeloma.~   "
105282|NCT02189317|"~     This study will consist of 80 patients ages 18 to 50 at the Emory Orthopaedic and Spine~     Center who are undergoing Anterior Cruciate Ligament (ACL) reconstruction with a quadriceps~     tendon autograft or bone patellar tendon bone autograft by Dr. Karas or Dr. Xerogeanes.~     Patients will be randomized into treatment and control arms. The treatment arm will include~     40 patients receiving liposomal bupivacaine intra-operatively in addition to the current~     standard pain control regimen. The control group will include 40 patients receiving the~     standard post-operative pain control regimen. Patients will be assessed to identify~     differences in post-operative pain, satisfaction, as well as concomitant pain medication use.~     Post-operative range of motion will also be assessed.~   "
105283|NCT02189304|"~     This is a single-center, Phase I, healthy adult subject study with a randomized, double~     blind, three period, three-treatment, cross-over design.~   "
105284|NCT02189291|"~     Objectives~      The objective of this study is to help identify the best practice regarding the use of~     indwelling catheter after minimally invasive urogynecologic surgery. Investigators propose a~     randomized controlled trial comparing the immediate removal of indwelling urethral catheter,~     after minimally invasive sacrocolpopexy, to the present standard catheter removal on post~     operative day one. Evidence based catheter management will be helpful to both providers and~     patients in post-operative decision making.~      Specific Aims~      Aim 1: To demonstrate that immediate removal of catheter after minimally invasive~     sacrocolpopexy results in shorter hospital stay than removal on postoperative day 1.~      Aim 2: To demonstrate that immediate removal of catheter after minimally invasive~     sacrocolpopexy confers no increased risk of re-catheterization.~      Aim 3: To demonstrate that immediate removal of catheter after minimally invasive~     sacrocolpopexy decreases the occurrence of urinary tract infection.~      Design~      A randomized controlled trial comparing the standard overnight indwelling urethral~     catheterization with removal of catheter immediately post surgery after minimally invasive~     sacrocolpopexy, at Oregon Health & Science University.~      Outcome measures~      Primary outcome measures are hospital stay in hours after completion of surgery and need for~     re-catheterization. Hospital stay will be counted from the time the patient leaves the~     operating room to the time she leaves the hospital. To avoid confounding, investigators are~     only including the first / morning case of the day. For re-catheterization, investigators~     will evaluate if patient was able to void after completion of surgery. Investigators will~     compare the post voiding residuals, the need for re-catheterizations and the numbers of~     patients going home with an indwelling catheter between the two groups. Investigators will~     also compare the number of urinary tract infections, as documented by urine culture and~     subsequent treatment, between the two groups.~      Study Subjects~      Study subjects will be women undergoing minimally invasive sacrocolpopexy. Women will be~     invited to participate in the study during their preoperative visit. If they agree to~     participation, this will be noted in their chart. Randomization to group will occur~     immediately following surgery.~   "
105285|NCT02189278|"~     Evidence-based guidelines recommend cancer surveillance procedures for breast cancer~     survivors including physical examination, mammography, breast self-exam, and gynecologic~     follow-up. The early detection of recurrent and new cancers can best be achieved through the~     combined, on schedule use of these surveillance procedures. Yet, data suggest that up to 55%~     of breast cancer survivors do not undergo these procedures as recommended. This study tests a~     telephone-based psychosocial intervention aimed at improving adherence to recommended~     surveillance in breast cancer survivors. The psychosocial intervention for improving~     adherence is compared to treatment as usual.~   "
105286|NCT02189265|"~     The purpose of this study is to investigate whether there has been a change in perinatal~     outcomes following the phased smoking ban introduction (January 2004 for workplaces; July~     2008 for bars and restaurants) workplaces in the Netherlands.~   "
105287|NCT02189252|"~     This is a randomized, open-label crossover study. The primary objective of this study is to~     compare the relative bioavailability of eicosapentaenoic acid (EPA), docosahexaenoic acid~     (DHA), docosapentaenoic acid (DPA), and the ethyl esters of EPA and DHA in plasma from a~     single 2 g or 4 g dose of Epanova® or 4 g Lovaza®.~   "
105288|NCT02189239|"~     The objective of the STRESS trial is to investigate in a mode of action setting the effect of~     Zeller Entspannung film coated tablets on saliva cortisol response versus Placebo after acute~     stress in healthy male volunteers. In addition, data on safety and tolerability of Zeller~     Entspannung will be obtained.~      A third arm including no treatment is tested as well. Approximately 72 healthy volunteers~     will be included into this randomized, double blind study. Study duration will be 7 days,~     study medication intake will be over 4 days: participants will take the medication one tablet~     three times a day (morning, midday, evening) the first 3 days, whereas on day 4 only two~     tablets will be taken (morning and midday).~   "
105289|NCT02189226|"~     The aim of this study is to evaluate the usefulness of pCLE (probe-based confocal laser~     endomicroscopy) compared with conventional chromoendoscopy (CE) for delineating the margin of~     early gastric cancer (EGC) with endoscopic submucosal dissection (ESD).~   "
105290|NCT02189213|"~     1 out of 8 children, adolescents, and young adults suffer from an anxiety disorder. Studies~     over the past decade show that selective serotonin-reuptake inhibitors (SSRIs), a class of~     medication that treats anxiety in adults, also works well in young adults, children, and~     adolescents with anxiety disorders, but only for about 50%. 50% will have undergone treatment~     for several months before it will be established that the medication is not working to treat~     the anxiety. The purpose of this study is to find a test that will predict treatment outcome~     from the beginning based on behavioral and biological measures.~   "
105291|NCT02189200|"~     Dyslipidemia is among the risk factors for cardiovascular diseases (CVD). Is's due to genetic~     and / or environmental factors such as inadequate dietary pattern. The occurrence of adverse~     events with statins, added to recent questions about their benefits on hard outcomes, opens a~     gap for the importance of seeking other forms of treatment of dyslipidemia, particularly in~     patients for secondary prevention. The consumption of oat bran, beta-glucan source of dietary~     fibers with supposed action in reducing the absorption of exogenous cholesterol and the~     endogenous synthesis of it, and source of avenanthramides, phytochemical compounds with~     alleged antioxidant in lipid membranes, can be effective strategy for secondary prevention of~     atherosclerotic disease.~   "
105292|NCT02189187|"~     The goal of this project is to characterize changes in emotion regulation pathways associated~     with healthy behaviors in people who have recently lost weight and are seeking to maintain~     weight loss over a 1-year period.~   "
105293|NCT02189174|"~     To estimate the maximum tolerated dose (MTD) or recommended dose for phase II (RP2D) of~     CLR457 and to investigate the anti-tumor activity of CLR457~   "
105294|NCT02189161|"~     Assess the safety, feasibility, and patient tolerability of circumferential radiofrequency~     ablation (RFA) to the anal canal for patients with anal intraepithelial neoplasia (AIN).~     Patients will have AIN with high grade squamous intraepithelial lesions (HSIL) and the RFA~     will be applied using the Barrx™ Ablation System.~   "
105320|NCT02188823|"~     The study is a pilot, designed to provide data regarding the feasibility and acceptability of~     conducting such a study on a larger scale. The present study is a clinical trial assessing a~     programs to help people manage prediabetes and lose weight with a low-carbohydrate diet (LC)~     along with information about positive affect, mindful eating strategies, exercise, and sleep.~   "
105295|NCT02189148|"~     Preeclampsia is a complication of pregnancy related to adverse maternal and neonatal~     outcomes, including fetal growth restriction and perinatal death. Several measures are used~     or under investigation (low-dose aspirin, low-molecular weight heparin, calcium, folic acid,~     among others) for the prevention of preeclampsia. Unfortunately, most high-risk women who~     could benefit from those preventive measures are not identified until late in pregnancy.~     Recent evidences suggest that the investigators could identify women at risk of developing~     preeclampsia using a combination of serum and ultrasound biomarkers in the first-trimester of~     pregnancy. This screening test needs external validation. A first-trimester screening~     strategy will strengthen clinical research on preeclampsia and will contribute to the~     development of strategy combining the prediction and prevention of the disease and its~     related complications.~   "
105296|NCT02189135|"~     Type 2 diabetes mellitus (T2DM) is a chronic condition that is one of the major causes of~     illness, disability, and death in Malaysia with an increasing prevalence. Despite the best~     effort, only 1 in 3 patients ever meet their HbA1c goal. In most patients with type 2~     diabetes, the use of oral anti-diabetics is a mainstay in therapy. However, there is a risk~     of hypoglycaemia in most patients taking these drugs. This is especially important in T2DM~     Muslims wishing to fast during Ramadan as the dietary pattern changes to one large meal at~     sunset called 'Iftaar' and a light meal before dawn called 'Sahur'. Most Muslims will~     generally consume large quantities of fried and sugary foods when they break their fast or~     during the night. Given the importance and public health significance of poor diabetes~     management and its associated risk especially during Ramadan, the investigators aim to test~     the intervention of using remote monitoring within community provider practice for patients~     with T2DM. The investigators hypothesize that the combined use of a mobile enable glucometer~     which can directly feedback the patients glycaemic levels to the physicians will reduce and~     even eliminate the occurrence of hypoglycaemia whilst ensuring that patients remain~     euglycaemic throughout the whole Ramadan month.~   "
105297|NCT02189122|"~     The investigators will compare the effects of rapid release aspirin and NHP-544C on the~     prostacyclin response to intravenous bradykinin.~   "
105298|NCT02189109|"~     This clinical trial is testing the safety, tolerability and effectiveness of NVX-108~     administered via intravenous infusion in combination with standard radiation and~     chemotherapy.~      NVX-108 is being developed to increase the amount of oxygen delivered to tumors which is~     hoped to increase the effectiveness of radiation therapy.~   "
105299|NCT02189096|"~     Sepsis claims over 37,000 lives in the United Kingdom each year- more than lung cancer, and~     more than breast cancer, bowel cancer and HIV/AIDS combined. Less than two-thirds of patients~     who develop sepsis will survive. Sepsis can affect a person of any age, social background,~     and can strike irrespective of underlying medical conditions.~      An important element in improving the care of patient with sepsis is early identification and~     early intervention, both of which have been shown to improve outcomes. Physiological~     deterioration often precedes clinical deterioration as patients develop critical illness.~     Recognition of this has led to the development of Early Warning Score (EWS) systems which~     allow earlier identification of physiological deterioration. By assigning numerical values to~     various physiological parameters, a composite score can be assigned to a patient, allowing~     early identification of patients who are at risk of critical illness.~      EWS were initially developed to assist in the management of patients in the general ward~     setting. A recent study has shown that an increased EWS on arrival at the Emergency~     Department (ED) is associated with higher odds of adverse outcome amongst patients with~     sepsis. Consequently, the use of EWS could facilitate patient pathways to ensure triage to a~     high acuity area of the ED and senior clinician involvement at an early stage. The use of a~     standard single National EWS (NEWS) across the National Health Service in the United Kingdom~     has been recommended to improve patient care.~      NEWS also lends itself to extension to pre-hospital care and ambulance services. Most~     ambulance services routinely collect the physiological data required to calculate a NEWS~     score and indeed some ambulance services have incorporated this into electronic patient~     record forms (ePRF). An agreed NEWS score of greater than a specific level could be used as a~     trigger for ambulance service pre-alert of a receiving ED.~      Point of care measurement of lactate has also been shown to be feasible in the ED. Serum~     lactate is recognised as an independent predictor of mortality in sepsis and there may be~     potential for combining NEWS systems and point of care to further improve diagnostic accuracy~     for patients at risk of adverse outcomes.~      In this study, we aim to apply the use of early warning scores and point of care testing to a~     cohort of all ambulance patients to assess the feasibility and utility of this approach.~   "
105300|NCT02189083|"~     On the basis of empirical evidence and clinical practice, the investigators have developed a~     formula called Tumor-shrinking Decoction (TSD) used in the treatment of uterine fibroids~     (UFs). The investigators preliminary clinical observation has demonstrated the benefits of~     TSD in improving UFs.~      TSD is composed of 15 individual Chinese medicines: Astragalus Membranaceus, Semen Coicis,~     Poria, Curcuma longa L, and Fritillaria Thunbergii Miq, Cassia twig, Pollen typhae, Resina~     draconis, Lithospermum erythrorhizon, Halloysitum Rubrum, Rhizoma Corydalis processed with~     vinegar, Hirudo, Calcined corrugated sub , Oyster Shell and Laminaria Japonica Aresch.~      It is hypothesized that TSD can effectively reduce the fibroid size and improve the symptoms~     associated with UFs and the greater anti-tumor potency of TSD is associated with higher~     therapeutic doses.~      To test this hypothesis, one 16-week, double-blind, randomized, two-dose trial will be~     conducted in patients with symptomatic UFs to determine whether the high dose (217 g/day) of~     TSD could produce significantly greater effects in reducing the fibroid size and improving~     its related symptoms and biochemical profiles compared to the lower dose (69 g/day).~   "
105301|NCT02189070|"~     The purpose of this study is to determine the preference of patients regarding the approach~     for follow-up after percutaneous coronary intervention (PCI) procedures. We hypothesize that~     patients prefer questionnaires for annual follow-up assessment when compared to telephone or~     email.~   "
105302|NCT02189057|"~     The overall goal of this investigator-initiated trial is to evaluate the treatment outcome of~     depression utilizing platform algorithm products that can allow rapid identification of~     pharmacokinetic (PK) and/or pharmacodynamic (PD) genomic variation. This new technology may~     have the potential to optimize treatment selection by improving response, minimizing~     unfavorable adverse events / side effects and increasing treatment adherence.~   "
105321|NCT02188810|"~     This is a phase 1, research study is looking at the safety and acceptability of a new vaccine~     adjuvant (immune booster) called PAL when combined with the seasonal flu vaccine (Fluviral)~     to test the safety and effectiveness of new vaccines and medications on healthy volunteers.~      The study will enroll approximately 48 healthy adult participants, and occur over 3 years. In~     the first six months/180 days of the study participants will have visits to the study site~     during which safety and immunogenicity outcomes will be measured. From Day 181 to Year 3,~     participants will be contacted by telephone or email to collect information on any adverse~     events.~   "
113705|NCT02079129|"~     The study objective is to assess the agreement between cMRI PVL grading (based on regurgitant~     fraction) and TTE PVL grading (based on pressure half-time and the ratio of the jet arc to~     the circumference of the annulus).~   "
105303|NCT02189044|"~     Introduction: Among the systems of the organism, it is believed that the respiratory system~     is the one which gets older faster due to the greater exposure to environmental pollutants~     over the years.The Pilates method has emerged as a form of fitness particularly providing~     general welfare to the individual. Objective: To evaluate the effects of Pilates' exercises~     on respiratory muscle strength in elderly women. Methods: The investigators have studied 07~     women aged 60 and over, with preserved autonomy and cognitive skills. The Pulmonary Function~     Test (Spirometry) was performed using the Vitalograph® spirometer, model 8600. Respiratory~     muscle strength was obtained by technical measurements of maximal inspiratory pressure (MIP)~     and maximal expiratory pressure (MEP), through an analog Gerar manometer. The experiment~     lasted eleven (11) weeks. For comparative analysis of the data obtained in the evaluations,~     the investigators applied the paired t test and a significance level of 5%.~   "
105304|NCT02189031|"~     Upper limb amputation is a devastating injury that leaves many thousands of typically young~     and active individuals in the US to rely on artificial arms and hands to help restore their~     lost function. The investigators research is focused on helping these individuals to feel~     where their prosthetic limbs are moving without having to look at them by developing devices~     and approaches to provide sensory feedback of limb movement through the nerves that once~     served the missing limb.~   "
105305|NCT02189018|"~     Peripheral artery disease (PAD) results in blockages of arteries (blood vessels) in the legs~     and decreased blood flow to the legs. This may cause difficulty or pain with walking or other~     activities that use leg muscles. Exercise may help improve blood flow in the legs and improve~     the ability to walk. This research project is being implemented in adults with PAD to examine~     the effects of exercise or weight loss programs on lower extremity blood flow, health, and~     physical function.~   "
105306|NCT02189005|"~     The purpose of the study is to evaluate the efficacy and safety of PreCrea® on subjects with~     higher than normal blood sugar levels.~   "
105307|NCT02188992|"~     Between 6 and 16% of patients presenting to hospital emergency departments have infections,~     with half of these having signs of systemic inflammation (known as 'sepsis'). A second issue~     is that, at time of presentation, it can be difficult to determine who has inflammation as a~     result of infection and who does not.~      Some of the patients with infections will deteriorate to organ failure ('severe sepsis')~     including failure of the heart and blood vessels to maintain normal blood pressure ('septic~     shock'). Septic shock as arguably the most dangerous form of severe sepsis is associated with~     a significant mortality, which can be reduced by early intervention. However identifying~     those patients who are at high risk of deteriorating to septic shock can be difficult on~     initial presentation to hospital, and thus these patients risk being 'triaged' to an~     inappropriate level of care and/or missing the crucial early interventions which can modify~     mortality. Equally failure to identify which patients have underlying infections can lead to~     potential inappropriate targeting of antibiotics. Existing clinical and laboratory tests are~     often unable to accurately identify those patients with infection, and those who are likely~     to deteriorate to severe sepsis and septic shock.~      Investigators in this group have recently identified several signatures of immune system~     activation which predict those patients who are likely to deteriorate, and which patients~     with suspected infection subsequently have this confirmed. Such tests would have major~     benefits for the management of patients with early suspected infection and sepsis if they can~     be translated into a test usable in everyday clinical practice. This study aims to determine~     the prevalence of these markers in a cohort of patients admitted with suspected sepsis, and~     their predictive ability for developing established septic shock. From this investigators aim~     to derive an optimal test, to be tested in a validation cohort (ExPRES-Sepsis II) which will~     be suitable for everyday clinical practice, and thus take the next step towards developing a~     market-ready test.~      Study hypothesis is:~      Measurement of markers of immune activation will allow i) Risk stratification for~     deterioration into severe sepsis ii) Risk stratification for death amongst patients~     presenting with sepsis iii) Identification of patients with confirmed sepsis~   "
105308|NCT02188979|"~     BACKGROUND Unpredicted difficult tracheal intubation (DTI) with Macintosh laryngoscopy occurs~     frequently in obese patients. We investigated the incidence of DTI using the GlideScope®~     videolaryngoscope (GVL) with an algorithm based on a pre-operative assessment with the El~     Ganzouri Risk Index (EGRI).~      METHODS We prospectively enrolled morbidly obese patients (BMI>40 kg/m2) undergoing abdominal~     surgery. Patients were scheduled for flexible fibre optic bronchoscopic intubation (FFBI) or~     GVL intubation if the EGRI score was ≥7 or <7, respectively. The primary outcome was the~     occurrence of DTI that was defined as Cormack and Lehane (C&L) grades ≥III, Intubation~     Difficulty Scale (IDS)>5 and modified IDS (mIDS)>5. A numeric rating scale (NRS) was also~     used. Secondary outcomes included intubation success during the first attempt, the time to~     Cormack (TTC), the time to intubation (TTI), failure to intubate, oxygen desaturation and~     difficult ventilation.~   "
105309|NCT02188966|"~     In the Emergency Department Regional Hospital Horsens a monitor will display Geographical~     Information System data (GIS data) for all ambulances with the hospital as final destination.~     The location, estimated time of arrival (ETA) and urgency code for the ambulances will be~     showed. Furthermore the patient's name, personal identification number and the primary~     message received by the emergency medical dispatch center resulting in ambulance dispatch~     will be displayed. This may enable the coordinating nurse to optimize timing of the ad hoc~     trauma team and medical emergency team activation. The teams are activated if the patient's~     condition is assessed to be of the highest urgency and/or severity - triage 1 or red. The~     coordinating nurse makes this assessment on the basis of information from the ambulance~     personnel and makes the decision to activate the team and when to do it. In this study the~     investigators want to examine if the availability of GIS data in the emergency department~     results in reduced waiting time for the members of the trauma team and medical emergency~     team. The study will be conducted as a before and after study.~   "
105310|NCT02188953|"~     The purpose of this study is to pilot test the effectiveness, acceptability, and palatability~     of ACCS100 in a high-risk Kenyan population.~   "
105311|NCT02188940|"~     Obese asthmatics have more severe symptoms, reduced lung function, poorer quality of life and~     a reduced response to inhaled corticosteroid medication compared to non-obese asthmatics. In~     addition, the impact of a weight-loss program on clinical control and psychological outcomes~     has been poorly demonstrated and the effect of exercise training remain unknown. The~     investigators aim to investigate the effect of exercise training in a weight-loss program on~     asthma clinical control (primary outcome), health factors related to quality of life and~     psychosocial symptoms (secondary outcomes) in obese patients with moderate-to-severe~     persistent asthma. Physical activity, inflammatory profiles and sleep disorders will also be~     evaluated. The investigators' hypothesis is that exercise as part of a weight-loss program is~     more effective to lose weight and improve asthma control, quality of life and psychosocial~     symptoms in obese asthmatics.~   "
105370|NCT02188160|"~     The primary purpose of this study is to determine the efficacy and safety of KPI-121 0.25%~     ophthalmic suspension compared to vehicle (placebo) in subjects who have a documented~     clinical diagnosis of dry eye disease. The product will be studied over 28 days, with 1-2~     drops instilled in each eye four times daily (QID).~   "
105312|NCT02188927|"~     Participation in a primary screening colonoscopy programs remains low. Advanced notification~     letter has been shown to increase participation in colorectal cancer screening with fecal~     occult blood testing and to be cost effective compared to standard invitation. It is unknown~     whether advanced notification letter increases participation rate in primary colonoscopy~     screening program.~      We hypothesize that an Advance Notification Letter will have significant influence on~     participation in screening colonoscopy, comparing to standard invitation procedure and will~     thus result in higher efficiency of the program.~      This randomized controlled study aims to compare the participation rate in screening~     colonoscopy in response to advanced notification plus standard invitation letter and standard~     invitation letter alone.~      Material and methods: 6800 individuals aged 55-64 years will be drawn from the Population~     Registry and randomly assigned in a 1:1 ratio to the group invited for screening colonoscopy~     with advanced notification letter (send two weeks before standard invitation) plus standard~     invitation (send six weeks before planned screening colonoscopy) or to standard invitation~     only (send six weeks before planned screening colonoscopy). The sample size was calculated to~     detect 3% difference in participation rate between the groups (25% vs 28%) with 80% power.~   "
105313|NCT02188914|"~     Inhalants substance misuse is an important public health problem whose prevalence is~     approximately 1% in the general population and 7% among high school students in Mexico.~     Furthermore Inhalants substance misuse has increased in the recent years (Villatoro et al.,~     2011). According to the Diagnostic and Statistical Manual of Mental Disorders fifth edition~     (DSM-5) inhalant use disorder is a problematic pattern of use of a hydrocarbon-based inhalant~     substance leading to clinically significant impairment or distress. There are studies to~     suggest that long-term exposure to inhalants is associated with structural brain~     abnormalities, as well as neuropsychological impairments. However many of these studies have~     been limited to the gross anatomical report, therefore is necessary the use of complimentary~     techniques which provide a better understanding of brain. To the date there is no evidence of~     the use of positron emission tomography, and there are few studies have employed other~     magnetic resonance imaging methodologies such as diffusion tensor imaging that can be used to~     know the metabolic activity and white matter tract integrity respectively in inhalant use~     disorder participants. The purpose of this study is evaluates the effects of the inhalant use~     disorder in the brain. The investigators will be using positron emission tomography (PET),~     Magnetic Resonance Imaging (MRI) and diffusion tensor imaging (DTI). As well as, this study~     will examine the impact of inhalants consumption on executive function performance and the~     transcriptomic changes associated with inhalants consumption. The investigators hope that the~     data gathered from this study will lead to the development of more effective treatments~   "
105314|NCT02188901|"~     B-mode ultrasonography (B-US), a standard method of surveillance of hepatocellular carcinoma~     (HCC), has a fair sensitivity of 63% in detecting early stage HCC. Sonazoid, a contrast agent~     for ultrasonography, has reported to have superior sensitivity in detecting focal liver~     lesion since it has ability of Kupffer phase imaging as well as vascular phase imaging. So~     our aim is to compare the detection rate of early stage HCC and false referral rate of HCC~     between B-mode US and Sonazoid-enhanced ultrasonography (S-US) within the same prospective~     data group. Our hypothesis is that S-US has superior detection rate of early stage HCC (5%)~     than that of B-mode US (3%).~   "
105315|NCT02188888|"~     Clinical study suggests that beta-blockers by decreasing heart rate together with an increase~     in stroke volume do not negatively affect cardiac output allowing an economization of cardiac~     work and oxygen consumption in patients with septic shock. Whether this hemodynamic profile~     leads to an amelioration of myocardial performance is still unclear. The objective of the~     present study is therefore to elucidate whether a reduction in heart rate with esmolol is~     associated to an improvement of cardiac efficiency in patients with septic shock who remained~     tachycardic after hemodynamic optimization.~   "
105316|NCT02188875|"~     Previous studies suggest self-regulatory techniques including self-monitoring, and SMS~     text-messaging as an intervention modality, can modify health behaviors including physical~     activity (PA). The primary purpose of this study was to examine change in objectively~     measured PA in a randomized controlled pilot trial that tested a wearable sensor/device~     (Fitbit One) for self-monitoring and SMS text-messaging prompts to promote PA in~     overweight/obese adults. In a 2-group design, 67 participants were provided the Fitbit One~     and half were randomized to receive 3 daily SMS-based PA prompts. A Fitbit One was provided~     to facilitate self-monitoring with a wearable tracker for instant feedback and website of~     daily PA summaries. Outcome measures were number of steps and minutes of PA by~     intensity-level using two accelerometers: Actigraph GT3X+ (primary) at baseline and 6-week~     follow-up and Fitbit One (secondary) at baseline and weeks 1-6. The main hypothesis was that~     text messaging plus the Fitbit One would show a greater increase in steps and minutes of PA~     compared to only the Fitbit One at 6-week follow-up.~   "
105317|NCT02188862|"~     The purpose of this study is to investigate whether there are genetic differences between~     patients with rheumatic heart disease and members of the general population.~   "
105318|NCT02188849|"~     To determine, in a double blind trial, the effects of creatine supplementation during 12~     weeks on muscle mass and function of community living older women subjected to resistance~     training. Material and methods: Fifty healthy older women will be selected for the study. All~     participants will be subjected to a progressive resistance training program using elastic~     bands and weights, consisting in three sessions per week lasting 1 hour. Participant will be~     randomly allocated in a double blind fashion, to receive creatine 5 g per day or an identical~     placebo. The training and supplementation period will last 12 weeks. At baseline and at the~     end of the study, body composition will be measured by dual energy x-ray absorptiometry,~     rectus femoris cross sectional height and surface will be measured by ultrasound, quadriceps~     strength will be measured in a quadriceps table and 12 minutes' walk will be assessed. The~     main outcome measure will be quadriceps cross sectional height. Expected results: We expect~     that creatine supplementation will increase rectus femoris height over and above the effect~     of resistance training.~   "
105319|NCT02188836|"~     This study specifically evaluates the effects of electromagnetic stimulation for diaphyseal~     femur fractures using a device developed by the investigators.~      The hypothesis is that patients with femoral diaphysis treated with the electromagnetic~     stimulation have less non-union after six months than patients treated with a placebo device.~   "
105323|NCT02188784|"~     The purpose of this study is to determine if oral iron (Fe) polysaccharide is superior to~     oral placebo in improving functional capacity as measured by change in peak VO2 (oxygen~     uptake) by CPET (Cardiopulmonary Exercise Testing) , of a broad population of patients with~     HFrEF (Heart Failure with Reduced Ejection Fraction) and Fe deficiency at 16 weeks.~      Hypothesis: In a broad population of HFrEF patients with Fe deficiency, compared to oral~     placebo, therapy with oral Fe polysaccharide will be associated with improvement in~     functional capacity at 16 weeks as assessed by CPET.~   "
105324|NCT02188771|"~     This is a Phase I, prospective, active-controlled, randomized, open-label, clinical trial~     designed to assess the safety and tolerability of single intra-articular injection of~     RegenoGel-SP for the treatment of OA.~      RegenoGel-SP is composed of fibrinogen in plasma linked to a high molecular weight HA. The~     viscoelastic properties resulting from the combination of these two natural macromolecules is~     further enhanced by joint surface associated factors to generate a viscoelastic gel with~     superior stability and mechanical integrity.~   "
105325|NCT02188758|"~     The goal of this study is to identify chemical compounds in the blood and sputum (i.e.,~     biomarkers) that are associated with objective measurements of health status in patients with~     cystic fibrosis (CF). This study builds upon observations that blood levels of hepcidin-25, a~     protein that regulates how the body uses and stores iron, vary during CF pulmonary~     exacerbation (CFPE).~   "
105326|NCT02188745|"~     Before anti-estrogens such as tamoxifen were developed to treat estrogen receptor~     (ER)-positive breast cancer, high-dose estrogen therapies were used. This seems~     counterintuitive since anti-estrogens block ER function, while estrogens increase ER~     function, but these therapies are effective to similar extents for the treatment of~     metastatic ER+ breast cancer. Estrogen therapies are most effective against cancers that~     develop resistance to anti-estrogens, likely because such cancers have adapted to grow~     without ER function, and restoring ER function (with estrogen) is damaging to the cancer~     cells. In some patients with ER+ breast cancer that becomes resistant to anti-estrogens,~     treatment with the estrogen 17b-estradiol induces tumor response. Furthermore, when~     17b-estradiol-sensitive tumors eventually become resistant to 17b-estradiol, switching back~     to anti-estrogen therapy is often effective. These observations suggest that cancers can~     alternate between anti-estrogen-sensitive and 17b-estradiol-sensitive states. The~     investigators hypothesize that treatment with alternating 17b-estradiol / anti-estrogen~     therapies on a defined 8-week / 16-week schedule will more effectively prevent cancer growth~     than continuous treatment with either type of therapy in patients with metastatic~     anti-estrogen-resistant ER+ breast cancer.~   "
105327|NCT02188732|"~     This randomized clinical trial (RCT) of 300 persons with serious mental illness (SMI) and~     medical comorbidity will evaluate outcomes for n=100 in a Community Based Health Home alone~     (CBHH), compared to n=100 also receiving Self-Management Training (CBHH+SMT), and n=100 also~     receiving Automated Telehealth (CBHH+AT). The investigators will test the following 3~     hypotheses:~      Hypothesis 1: CBHH+SMT and CBHH+AT compared to CBHH alone, will be associated with greater~     health self-management and greater mental health self-management.~      Hypothesis 2: CBHH+SMT and CBHH+AT compared to CBHH alone, will be associated with greater~     reduction in risk of early mortality and (Exploratory E2) in psychiatric symptoms.~      Hypothesis 3: CBHH+SMT and CBHH+AT compared to CBHH alone, will be associated with less acute~     service use and less acute service use costs.~   "
105328|NCT02188719|"~     The purpose of this study is look at the safety of:~        -  Taking a specific combination of immunosuppressant drugs after liver transplantation~        -  Receiving one of three different doses of donor-alloantigen-reactive regulatory T cells~          (darTregs) while taking this specific combination of drugs~   "
105329|NCT02188693|"~     The primary purpose of our study is to evaluate whether gemcitabine as a single agent is~     superior to observation in improving progression-free survival (PFS) in patients with~     metastatic breast cancer (MBC) who achieved disease control with an initial six cycles of PG~     as their first-line treatment~   "
105330|NCT02188680|"~     The patients having a syndrome SII would be more intolerant in the fructose than the healthy~     subjects and would benefit from a fructose diet but also from the fructans which contain some~     fructose. The intolerance in the fructose is diagnosed thanks to a respiratory test after~     absorption of fructose. However, the eviction of the fructose is sometimes recommended to the~     patients without having realized beforehand the test of intolerance.~   "
105331|NCT02188667|"~     The purpose of this study is to assess the impact of clinician education, electronic health~     record integrated patient reported outcomes, and electronic health record integrated decision~     support on pain-related care quality, outcomes, and service utilization.~   "
105332|NCT02188654|"~     Psoriatic arthritis (PsA) is a systemic, inflammatory disease. The chronic inflammation in~     PsA predisposes patients to the metabolic syndrome (MetS). MetS is associated with systemic~     inflammation and proinflammatory cytokines. Clinical observations and experimental results~     argue for an anti-inflammatory and immunosuppressant property of MET.~   "
105333|NCT02188641|"~     Psoriatic arthritis (PsA) is a particular pattern of inflammatory arthritis often seen in~     association with psoriasis. PsA patients have a higher prevalence of comorbidities including~     obesity, metabolic syndrome, depression and premature cardiovascular disease. There is~     evidence that obesity is associated with PsA. A 12 month study was conducted to determine~     whether exercise and dietary weight loss are more efficacious, either separately or in~     combination, than standard care alone in improving symptoms and signs in obese adults with~     PsA.~      Fifty-five obese PsA patients with a body mass index (BMI) ≥30, were recruited. Patients were~     randomized into usual lifestyle (controls), diet only, exercise only, and diet plus exercise~     groups for 12 months. Disease activity was assessed. Blood samples collected after 12 hours~     overnight fasting were analysed for glucose, lipid profile, ESR, hsCRP, proinflammatory~     cytokines; tumour necrosis factor alpha (TNF-alpha), interleukin-6 (IL-6) and interleukin-17~     (IL-17). The primary outcome measures included improvement in ACR20. Secondary endpoints~     included reduction in PASI score, DAS28-CRP response and physician and patient global~     assessment (PGA). Safety and tolerability were also assessed. Data was collected at baseline~     and every 6 months.~   "
105371|NCT02188147|"~     The purpose of this study is to conduct an observational investigation of a novel care path~     used to manage emergency department (ED) presenting syncope patients on an outpatient basis.~   "
105334|NCT02188628|"~     Locally, stroke remains the 4th cause of death, causing 8.4% of deaths annually in Singapore,~     and a leading cause of neurological disability worldwide. Nearly 40% of the stroke survivors~     will require specialized rehabilitation. In recent years, robot-aided therapy has been~     proposed as a means of complementing traditional therapy to alleviate the burden on~     therapists and on the healthcare system. For shoulder/elbow rehabilitation, dozens of robots~     have been proposed in the literature but only half a dozen have been commercialized and~     typically none are seen in local clinics, due to exceedingly high costs. A novel, compact,~     inexpensive robotic interface, named 'H-Man', was recently designed and developed at NTU for~     experiments in motor control neuroscience. The H-man can generate computer-controlled force~     fields to assist or resist a subject's motion and is potentially an optimal trade-off between~     clinical efficacy and robotic complexity. A first prototype of the H-Man is available at~     NTU.The primary aim of this proposed project is to assess to what extent the investigators~     H-Man is suitable for rehabilitation purposes using a feasibility pilot clinical trial design~     involving stroke survivors. The investigators believe that H-Man can be used for~     neuro-rehabilitation of stroke patients with hemiparetic weakness, motor incoordination and~     motor ataxia of the upper limbs.In close cooperation between clinicians at the TTSH and NTU~     engineers, a portable version of the H-Man will be developed which will be tested in a 12~     subject Pilot study, refined and then used in a 44 subject Randomized Controlled Trial (RCT)~     study. At the same time, the feasibility of H-Man integration for a pared down home use model~     will be assessed in 4 subjects.~      The investigators primary hypothesis is that sub-acute/chronic patients will exhibit~     clinically significant decreases of impairment when training with the H-Man combined with~     standard arm therapy on robot-measured scales and standardized clinical scales, at the level~     of elbow/shoulder after 18 sessions of training on the H-Man.~   "
105335|NCT02188615|"~     The primary objective is to compare neo-adjuvant chemoradiotherapy followed by Mckeown~     Minimally Invasive Esophagectomy (MIE) Versus Mckeown MIE, pure radical chemoradiotherapy in~     terms of the overall survival time (OS) in patients with Stage IIB or III squamous cell~     esophageal carcinoma.~   "
105336|NCT02188602|"~     The investigators would like to investigate the effect of chloride dosing on the development~     of acute kidney injury in critically ill patients. The investigators hypothesis is that~     administering intravenous fluids with higher chloride content are more likely to lead to~     acute kidney injury.~   "
105337|NCT02188589|"~     To evaluate the safety and feasibility of the INEX Nasal Implant in subjects with moderate to~     severe nasal valve collapse.~   "
105338|NCT02188576|"~     This research study is being performed to evaluate two different doses of Tranexamic acid~     (TXA) in children who have craniosynostosis and have been referred to Boston Children's~     Hospital for corrective surgery. This surgery is associated with significant blood loss and~     frequently requires the transfusion of blood. TXA is a medication that reduces the amount of~     bleeding during surgery by improving clotting of the blood at the surgical site. TXA is an~     FDA-approved drug that is routinely used in infants and children undergoing major surgery~     including heart surgery, craniofacial surgery and scoliosis surgery. It has been shown to~     decrease both the amount of bleeding and the amount of blood transfusion needed. We would~     like to compare the different doses of TXA to see if a lower dose has the same effect on~     blood loss as a higher dose. We are also interested to learn why TXA seems to work better in~     some patients than in others. In order to study the effect of this drug we would like to give~     this drug to your child and measure the blood loss and the volume of blood given to your~     child during his/her surgery.~      The research is being done at two sites; Boston Children's Hospital and Gaslini Children's~     Hospital in Genoa, Italy. The main study doctor from Boston Children's Hospital is Dr. Susan~     Goobie. The Department of Anesthesiology at Boston Children's Hospital is sponsoring this~     study.~      We are planning to study a total of 68 infants and children from age 3 months to 6 years old~     scheduled for open craniosynostosis surgery at Boston Children's Hospital or Gaslini~     Children's Hospital.~   "
105339|NCT02188563|"~     Smoking is the greatest risk factor for upper aerodigestive cancers (thoracic or head and~     neck) and negatively impacts survival and other outcomes, but many patients have difficulty~     quitting after their diagnosis. Smoking cessation interventions for cancer patients thus far~     have had limited success. This is a pilot randomized controlled trial designed to determine~     if a new comprehensive, evidence-based smoking cessation intervention can improve quit rates~     for cancer patients who smoke.~   "
105340|NCT02188550|"~     The purpose of the study is to determine if the combination of Everolimus and Letrozole is~     effective in the treatment of women with either recurrent or persistent epithelial ovarian,~     fallopian tube, primary peritoneal or endometrial cancer.~      Experiments have shown that everolimus (Afinitor®) can prevent cells such as cancer from~     growing in number. Therefore, everolimus (Afinitor®) is being tested in specific diseases to~     stop cells from growing too fast (as in cancer).~      Everolimus (Afinitor®) has been FDA approved for adults with advanced kidney cancer (Renal~     Cell Carcinoma). Everolimus (Afinitor®) received approval for patients with subependymal~     giant cell astrocytoma (SEGA), a brain tumor seen with genetic conditions called tuberous~     sclerosis complex (TSC) who require therapy, but are not candidates for surgery. Everolimus~     (Afinitor®) was approved for pancreatic neuroendocrine tumor (PNET) in patients with~     unresectable, locally advanced, or metastatic disease. Everolimus (Afinitor®) received~     approval for the treatment of postmenopausal women with advanced hormone receptor-positive,~     HER2- negative breast cancer (advanced HR+ BC) in combination with exemestane, after failure~     of treatment with letrozole or anastrozole. Everolimus (Afinitor®) also received approval for~     the treatment of patients with TSC who have renal angiomyolipoma not requiring immediate~     surgery.~      Everolimus (Afinitor®) has been used to treat patients in clinical studies since 2002 and~     approximately 25,645 patients (as of 30-Sep-2012) have been treated with everolimus~     (Afinitor®).~   "
105341|NCT02188537|"~     Trial objectives:~      To decide whether the addition of nelfinavir to the approved antimyeloma therapy with~     bortezomib and dexamethasone has sufficient activity in proteasome inhibitor-resistant~     myeloma patients to merit further clinical investigation in a prospective controlled trial.~      Additional research questions:~      To collect myeloma cell samples from proteasome inhibitor-resistant myeloma patients for the~     assessment of the biology of proteasome inhibitor resistance and the identification of~     predictive markers for response to nelfinavir-based antimyeloma therapy.~   "
105382|NCT02188004|"~     primary purpose:Evaluate the prevalence and incidence of HPV infection and related diseases~     in subjects.~      Secondary purpose:Analyze risk factors of HPV infection and related diseases.~   "
105491|NCT02186574|"~     The purpose of the study is to determine how effective preemptive tenofovir therapy is in~     preventing the re-activation of Hepatitis B infection, in patients who are receiving~     rituximab-based chemotherapy for Non-Hodgkin's Lymphoma or CLL/SLL. The rate of re-activation~     will be compared between patients who receive preemptive tenofovir and patients who receive~     tenofovir as needed.~   "
105342|NCT02188524|"~     For the duration of 10 weeks, participants will be asked to maintain their current levels of~     physical activity and to take part in three testing sessions over the course of 10 weeks.~     Objective and subjective measurements will be obtained at (week 0), at midpoint (week 5) and~     after the intervention terminates (week 10). The objective measurements will be taken by~     inserting pressure sensors directly into the shoe and recording the centre of pressure.~     Markers will be attached to the surface of the body on the shoulders, feet and belly button~     and video recording will be used to assess the movement of the centre of mass. The first task~     requires individuals to stand in one spot with their eyes open, and then eyes closed.~     Secondly, standing in one place, upon an auditory cue, arms will be lifted to the sky as fast~     as possible. Lastly, participants will walk around a set of chairs while music plays and when~     the music stops, this is a cue to stop walking. The Timed-Up-and-Go test requires~     participants to rise from a seated position, walk 3 meters, turn and return to their original~     seated position. The Berg Balance Scale requires the completion of a 14 task sequence which~     evaluates balance ability during seated, and various standing positions as well as~     transitioning movements. The other measurements taken are collected via a questionnaire about~     balance confidence level. Upon arrival, participants are required to report whether they have~     experienced a fall since the last class attended and if yes, a follow-up questionnaire is~     also required to gain information about the nature of the fall.~   "
105343|NCT02188511|"~     E-cigarettes are an increasingly popular alternate nicotine delivery system, but nothing is~     known about the effects of electronic cigarettes on the lungs. We hypothesize that~     e-cigarettes disorder airway epithelial and alveolar macrophages biology. Our goal is not to~     carry out a large epidemiologic study of electronic cigarette users to study lung function~     and other possible abnormal clinical phenotypes, but rather to focus on whether electronic~     cigarette smoke disorders the biology of the lung cells first exposed to the electronic~     cigarette smoke, a parameter that is the precursor of abnormalities in lung function and~     which is far more sensitive than lung function.~   "
105344|NCT02188498|"~     The objective of this study is to determine if a non-invasive technique, using an innovative~     analysis of electrocardiogram (ECG) data, would allow for detection of respiratory events~     during sleep and discrimination between central and obstructive apnea. Obstructive Sleep~     Apnea (OSA) is the most common respiratory disturbance seen during sleep, with an estimated~     prevalence of 10 % in the population and is strongly associated with the development of~     cardiovascular disease. In patients with underlying cardiac disease, particularly in heart~     failure (HF), central respiratory events such as Cheyne-Stokes Respiration (CSR) are often~     seen during sleep. The presence of CSR is also associated with increased cardiovascular~     morbidity and mortality. Currently, the identification and classification of sleep related~     respiratory disturbances is performed during over-night sleep studies (polysomnography),~     which are labor-intensive, time-consuming, expensive and difficult for patients. Thus, the~     development of alternative techniques to assist in the identification of those events in the~     outpatient setting is of marked importance for widespread screening of sleep apnea.~   "
105345|NCT02188485|"~     With the long-term goal of improving interventions for late-life suicide, the purpose of this~     study is to examine whether a mechanism by which behavioral interventions reduce risk for~     late-life suicide is by increasing social connectedness. The investigators propose to examine~     whether a manualized intervention that targets connectedness--ENGAGE--increases connectedness~     in older adults who report clinically significant depression and~     disconnectedness—operationalized as feeling lonely and/or like a burden on others. The~     investigators propose a randomized controlled trial comparing the ENGAGE intervention with~     care-as-usual (CAU), using n=100 primary care patients aged ≥ 60 years who report social~     disconnectedness (i.e., loneliness or burdensomeness) and either Minor or Major Depression.~     At baseline, 3-week, 6-week and 10-week assessments, subjects will report on social~     connectedness, depression, and suicide risk. The investigators hypothesize that those~     subjects assigned to ENGAGE will report greater increases in connectedness—measured as~     greater belongingness and lower burdensomeness—compared to CAU; that ENGAGE will produce~     greater reductions in depression and suicide ideation than CAU; and that changes in~     depression will be accounted for changes in social connectedness.~   "
105346|NCT02188472|"~     The purpose of the study is to investigate phenoxymethylpenicillin (the v-penicillin) and~     trimethoprim's possible induction of oxidative stress in human cells. The induction is~     examined by comparing changes in oxidative stress in the treatment group with the change in a~     placebo group. The study is a randomized-based placebo-controlled study. Each treatment group~     consists of 30 healthy male volunteers who consume either v-penicillins, trimethoprim or~     placebo over 7 days. The induction of oxidative stress is measured by 8-oxoguanosine and~     8-oxodeoxoguanosine, isolated from urine. A t-test will be performed to compare drug~     treatment with placebo. The results will be published.~   "
105347|NCT02188459|"~     Smoking during pregnancy adversely affects the health of the mother and her developing baby.~     Maternal smoking approximately doubles the risk of miscarriage, placental complications,~     preterm delivery, low birth weight and fetal and newborn death. The most common adverse~     effect of smoking during pregnancy is low birth weight, which sharply increases the risk of~     the newborn becoming ill or dying. In the US, maternal smoking is responsible for 30% of low~     birth weight babies, 10% of premature deliveries, and 5% of infant deaths. Fortunately,~     smoking cessation by pregnancy week 16, or as late as the third trimester, results in a~     near-normal weight infant at birth. Even reductions in smoking increase birth weight.~      Despite the known risks, the majority of women who are smoking at the time of their first~     prenatal visit continue to smoke. Bupropion is approved by the US Food and Drug~     Administration (FDA) for smoking cessation in people who are not pregnant, but there are no~     carefully controlled studies on the use of Bupropion to help pregnant women quit smoking.~     Bupropion is also FDA approved to treat depression, and some pregnant women have taken it for~     that purpose, even though it has not been formally tested. The investigators propose to~     conduct a randomized, parallel-group, double-blinded, placebo-controlled, 10 week trial of~     Bupropion in 360 pregnant women who smoke daily and wish to quit smoking.~      The study has three primary hypotheses. First, the investigators hypothesize that Bupropion~     treated subjects will decrease the frequency of smoking more than placebo-treated subjects.~     Second the investigators hypothesize that Bupropion treated subjects will have greater~     positive pregnancy and child health outcomes than placebo-treated subjects. Third the~     investigators hypothesize that Bupropion treated subjects will have decreased frequency of~     depressive symptoms and cigarette craving than placebo-treated subjects. These finding will~     provide information on the safety and efficacy of bupropion treat for smoking cessation in~     pregnant women.~   "
105402|NCT02187744|"~     The current study will compare PK, efficacy, safety, and immunogenicity of PF-05280014~     (Trastuzumab-Pfizer) in combination with Taxotere® and Carboplatin (Paraplatin) versus~     Herceptin® (Trastuzumab-EU) approved in the EU in combination with Taxotere® and Carboplatin~     (Paraplatin) in patients with operable HER2 positive, breast cancer in the neoadjuvant~     setting. The hypothesis to be tested in this study is the percentage of patients with steady~     state Cycle 5 Ctrough (Cycle 6 pre-dose) >20 µg/mL of trastuzumab-Pfizer is similar to~     EU-approved trastuzumab, using a margin of -12.5%.~   "
105348|NCT02188446|"~     Radical cystectomy provides the best cancer-specific survival for muscle-invasive urothelial~     cancer. However the postoperative morbidity remains at 11-68 %. Smoking and alcohol~     consumption above two drinks per day is associated with an increased risk of postoperative~     morbidity. Six-eight weeks of smoking and alcohol abstinence prior to elective surgery is~     recommended to reduce this risk, but for cancer patients the preoperative period is often~     very short. This randomised clinical trial (STOP-OP) will reach a conclusion on the effect of~     a new Gold Standard Programme for both smoking and alcohol cessation Intervention using the~     Gold Standard Programme (GSP) on the frequency and severity of postoperative complications~     after bladder cancer surgery.~   "
105349|NCT02188433|"~     Although smoking prevalence is decreasing in Hong Kong, there are still 645,000 daily smokers~     10.7% ( Thematic Household Survey 2012) and half will be killed by smoking (Lam ,2012) which~     accounts for over 7,000 deaths per year (Lam, Ho, Hedley, Mak, & Peto, 2001). Smoking also~     accounts for a large amount of medical cost, long-term care and productivity loss of US$688~     million (0.6% Hong Kong GDP) (McGhee et al., 2006) (Census & Statistics Department (Hong Kong~     Special Administrative Region government), 2001). Smoking is a highly addictive behavior and~     it is difficult for smokers with strong nicotine dependence to quit without assistance. On~     the other hand, reaching and helping the many smokers who have no intention to quit is a~     challenge, because they are unlikely to seek professional help from smoking cessation~     services. The Quit and Win programme provides an opportunity to reach and encourage a large~     group of smokers to make quit attempt and maintain abstinence. The Quit and Win model posits~     that smokers participating in the contest will have higher motivation to quit with incentives~     and better social support (Cahill & Petera, 2011). Studies have found that such quitting~     contests or incentive programs appeared to reach a large number of smokers and demonstrated a~     significantly higher quit rate for the quit and win group than for the control group (Cahill~     & Rafael, 2008).~      The Quit to Win Contest in 2014 and the study's interventions using cut down to quit approach~     are theoretically based on the Health Action Process Approach ( HAPA) for the intervention~     group (Schwarzer, 2008). The HAPA suggests that one's intention of behavior change can be~     fostered by knowing that the new behavior has positive outcomes as opposed to the negative~     outcomes that accompany the current behavior; and planning (action planning and coping~     planning) which serves as an operative mediator between intentions and behavior. Using~     gradual cut down approach on smoking cessation will probably increase smoker's self-efficacy~     on smoking cessation as the process could be achieved at the smoker's own perceived pace~     without placing too much pressure on themselves but with greater control of self in the~     cessation process. This was supported by the evidence that smoking reduction approach led to~     a greater self-efficacy to resist smoking and increased subsequent quitting (Broms, Korhonen,~     & Kaprio, 2008). Most importantly, reducing cigarette consumption will lower the nicotine~     dependence which is associated with later abstinence (Hughes et al., 2004). On the other~     hand, quitting immediately will have a less sense of control and may be subjected to relapse~     thus lower the self-efficacy on quitting.~      Therefore, the present study will examine (1) effectiveness of the cut down to quit (CDTQ)~     and quit immediately (QI) approaches; (2) explore the use of Community-Based Participatory~     Research (CBPR) model to build capacity and to engage community partners in taking on this~     important public health issue for sustainability in the community. In addition, process~     evaluation will be conducted to assess the effectiveness of the recruitment activity and how~     it is linked with the overall program outcomes.~   "
105350|NCT02188420|"~     After a stroke, there is an exaggerated inhibitory influence from the non-stroke hemisphere~     to the stroke hemisphere. Brain stimulation using repetitive transcranial magnetic~     stimulation (rTMS) to the non-stroke hemisphere can decrease this inhibition. Paired~     Associative Stimulation (PAS) may be a more effective way to produce this same inhibition, as~     shown in healthy subjects. However, it is not known whether this will translate to people~     with stroke. PAS consists of a peripheral nerve stimulus paired a short time later with a~     cortical stimulus to change the excitability within the brain. Thus the investigators will~     apply PAS to people with stroke, but the investigators need to first determine the most~     effective interpulse interval (IPI) between the peripheral and cortical stimuli. Our research~     question is which of three different IPIs is most effective in changing the excitability of~     the brain.~      The purpose of this study is to determine the optimal IPI between a peripheral nerve pulse~     and a cortical stimulus that will be most effective in changing excitability of the brain in~     people with chronic stroke. The investigators hypothesize that the cortical excitability of~     the nonstroke hemisphere will be most inhibited with the latency-5ms condition.~   "
105351|NCT02188407|"~     The aim of the study was to prospectively investigate the influence of one-lung ventilation~     (OLV) on the inflammatory response and to identify possible antiinflammatory effects of the~     volatile anaesthetic sevoflurane.~      Forty patients undergoing thoracic surgery with OLV were enrolled in this prospective,~     randomised study. The patients were randomly allocated into two groups to receive either~     propofol (Group P) or sevoflurane (Group S) for induction and maintenance of anaesthesia.~      Inflammatory mediators (Interleukin 6 (IL6), Interleukin8 (IL8), Interleukin 10 (IL10), (C-~     reactive protein)CRP) were measured intra- and postoperatively.~      Six hours after surgery oxygenation index (PaO2/FiO2) was calculated and chest X ray was~     taken and assessed.~      The clinical outcome determinated by postoperative adverse events was assessed as the~     secondary endpoint.~   "
105352|NCT02188394|"~     Greater occipital nerve (GON) anesthetic blockades are widely used for the treatment of~     headaches, yet its efficacy in migraine has hardly been assessed with controlled studies. The~     aim of this study is to evaluate the short-term clinical efficacy of GON anaesthetic~     blockades in chronic migraine and to analyze their effect on pressure pain thresholds (PPTs)~     in different areas. We hypothesize that those patients receiving real GON anesthetic blockade~     will receive greater improvements in pain nociception. We will conduct a double-blind,~     randomized, parallel and placebo-controlled clinical trial where one group will be treated~     with bilateral GON blockade with bupivacaine 0,5% and the other group will be treated with~     placebo.~   "
105353|NCT02188381|"~     Hypertension is the single most prevalent risk factor for heart diseases, heart failure,~     kidney failure and stroke. About 1 in 3 adults in the United States have hypertension.~     Approximately 28-30% of hypertensive patients suffer from resistant hypertension (RH).~     Inflammation has been implicated in the pathogenesis of the hypertension. Additional data~     suggests the involvement of gut microbiota in host normal cardiovascular functions and~     pathophysiology. Accumulating evidence demonstrates that antibiotic treatment benefits~     patients with acute coronary syndromes and reduces the incidence of ischemic cardiovascular~     events. Even though these studies did not address effects of antibiotic treatment on the gut~     microbiota, it is possible that gut microbiota could affect neurologic inflammation. Finally,~     intestinal microbiota has recently been proposed to modulate blood pressure (BP) through~     production of short-chain fatty acids. In order to investigate this, the investigators~     hypothesize that gut microbiota is involved in the neuroinflammation-mediated initiation and~     establishment of RH, and targeting gut microbiota by minocycline would produce beneficial~     outcomes in RH.~   "
105354|NCT02188368|"~     The purpose of this clinical research study is to evaluate the safety and effectiveness (good~     and bad effects) of pomalidomide given as part of a combination therapy that include more~     than just steroids to treat subjects with relapsed (subjects whose disease came back) or~     refractory (subjects whose disease did not respond to past treatment) multiple myeloma (MM).~      Pomalidomide (alone or in combination with dexamethasone) has been approved by the United~     States Food and Drug Administration (FDA) for the treatment of MM patients who have received~     at least two prior therapies, including lenalidomide and bortezomib, and have demonstrated~     disease progression on or within 60 days of completion of their last therapy. However, the~     use of pomalidomide in combination with other drugs used to treat MM, such as~     chemotherapeutic agents and proteasome inhibitors, is currently being tested and is not~     approved. Pomalidomide is in the same drug class as thalidomide and lenalidomide. Like~     lenalidomide, pomalidomide is a drug that alters the immune system and it may also interfere~     with the development of small blood vessels that help support tumor growth. Therefore, in~     theory, it may reduce or prevent the growth of cancer cells. The testing done with~     pomalidomide thus far has shown that it is well-tolerated and effective for subjects with MM~     both on its own and in combination with dexamethasone. Using another drug class, namely~     proteasome inhibitors, we have demonstrated that simply replacing a proteasome inhibitor with~     another in an established anti-myeloma treatment regimen can frequently overcome resistance~     regardless of the other agents that are part of the anti-myeloma regimen. Importantly, the~     toxicity profile of the new combinations closely resembled that of the proteasome inhibitor~     administered as a single agent. Based on this experience, we hypothesize that the replacement~     of lenalidomide with pomalidomide will yield similar results in a similar relapsed/refractory~     MM patient population.~   "
105355|NCT02188355|"~     The e-Ultimaster will further validate the safety and efficacy of Ultimaster DES system in~     unselected patients representing everyday clinical practice. Also the study will assess the~     impact of non-compliance with dual antiplatelet therapy, one month after stent implementation~     (frequently observed in every day clinical practice), on stent thrombosis.~   "
105356|NCT02188342|"~     The primary aim of this study is to determine whether an improvement in aerobic fitness, as~     judged by an increase in VO2peak, can be achieved within 31 days via HIT programme in a group~     of older, colorectal cancer patients.~   "
105446|NCT02187159|"~     The main objective of this trial is to compare change in weekly average daily pain score~     (ADPS) from baseline to Week 13 in subjects receiving either dose of DS-5565 versus placebo.~     Weekly ADPS is based on daily pain scores reported by the subject that best describes his or~     her worst pain over the previous 24 hours.~   "
105357|NCT02188329|"~     The primary purpose of the National Survey of Early Care and Education (NSECE) was to provide~     a comprehensive snapshot of both the availability and utilization of early care and education~     in the United States. The main objectives of the study included:~        -  Providing the first national portrait of the availability of early care and education~          for the full spectrum of care providers, including householders and providers from all~          50 states and the District of Columbia.~        -  Identifying early care and education and school-age care (ECE/SA) needs and preferences~          among households in the United States with children under age 13 as they pertain to~          supporting both the employment of parents and the development of children.~        -  Capturing data on all forms of non-parental care for all children in a household.~        -  Providing the perspectives of both families and providers on the services offered in a~          system where children are often in multiple arrangements and providers receive funding~          from multiple sources.~        -  Linking the data set collected with policy-relevant data.~        -  Increasing the understanding of the care received by low-income children and how that~          varies across communities.~      The NSECE is a set of four integrated, nationally representative surveys conducted in 2012.~     These were surveys of 1) households with children under 13, 2) home-based providers 3)~     center-based providers, and 4) the center-based provider workforce. Together they~     characterize the supply of and demand for early care and education in America and permit~     better understanding of how well families' needs and preferences coordinate with providers'~     offerings and constraints.~   "
105358|NCT02188316|"~     -  Cold forceps polypectomy and hot biopsy forceps electrocauterization (HBF) are still~          widely used methods for endoscopic resection of diminutive colorectal polyps~          (DCPs)(polyps smaller than 5 mm). Jumbo forceps may be more effective in the removal of~          DCPs because of their larger size.~        -  This was a prospective study of consecutive patients undergoing colonoscopy and found to~          have at least one diminutive polyp. One experienced endoscopist removed DCPs using~          either jumbo or hot biopsy forceps.~        -  Aim was to evaluate the histological quality and adequacy of the DCPs resected using~          jumbo forceps in comparison with HBF.~   "
105359|NCT02188303|"~     LY2944876 is an investigative drug for the treatment of Type 2 Diabetes Mellitus. Part A of~     the study will assess the safety and tolerability of single doses of LY2944876 in Japanese~     participants. Participation is expected to last up to about 7 weeks, not including screening.~      Part B of the study will investigate the safety and tolerability of multiple doses of~     LY2944876 in non Japanese participants. Participation is expected to last up to about 8~     weeks, not including screening.~      All doses will be administered as injections into the fatty layer just beneath the skin.~      Screening is required within 28 days prior to the start of the study. All participants will~     attend a post study safety assessment approximately 6 weeks after their final dose.~   "
105360|NCT02188290|"~     Study CR-AIR-006 is a part of the ATIR clinical development plan and will provide control~     data for patients treated with ATIR in clinical studies (e.g. study CR-AIR-007).~   "
105361|NCT02188277|"~     1. To assess the clinical and neurophysiological efficacy of Xeomin® vs. Botox® in children~          with spastic equine and equinovarus foot deformation in pediatric cerebral palsy~        2. To assess the safety of Xeomin® use as compared to Botox® in this patient population~   "
105362|NCT02188264|"~     This phase I/Ib trial studies the side effects and best dose of selumetinib when given~     together with cyclosporine in treating patients with solid tumors or colorectal cancer that~     have spread to other places in the body and cannot be cured or controlled with treatment.~     Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth. Biological therapies, such as cyclosporine, use substances made from living~     organisms that may stimulate or suppress the immune system in different ways and stop tumor~     cells from growing. Giving selumetinib and cyclosporine may be a better treatment for solid~     tumors or colorectal cancer.~   "
105363|NCT02188251|"~     The purpose of this study is to determine the effects of Activamp, a product containing~     gynostemma pentaphyllum extract, on body weight, fat loss and metabolic markers in healthy~     overweight adults.~   "
105364|NCT02188238|"~     The aim of this study is to help us understand how saliva forms a thin film inside the~     surfaces of the mouth which is known as the salivary pellicle, and how this film helps to~     protect our teeth from decay. We know that the thickness and physical properties (viscosity~     and mechanical strength) of the salivary pellicle influences:-~        -  How we chew and sense the structure of food in our mouth.~        -  How we digest the food and extract nutrients from it.~        -  Protection against tooth decay and infection.~      However, studies have only recently established the different proteins within the pellicle.~     The effects of oral care products (e.g. toothpaste, mouthwash etc.) and ingredients they~     contain on pellicle formation and removal remain poorly understood. Therefore we need to~     understand how the formation of the salivary pellicle is controlled by ingredients it comes~     into contact with such as those from food and oral hygiene products (e.g. toothpaste and~     mouthwash).~      In this study, we are asking volunteers to provide samples of saliva. We will take the saliva~     samples back to our labs and measure how they form films under different conditions and~     determine the influence of ingredients from oral hygiene on the film forming properties. We~     will also measure the protein content of the saliva sample to see how this affects pellicle~     formation. Eventually, this information together with knowledge from other studies, should~     lead to the development of more effective oral hygiene products.~   "
105365|NCT02188225|"~     The purpose of this study is to comparison the effect of acupuncture and Fluoxetine on~     improvement quality of life among menopausal women.~   "
105366|NCT02188212|"~     Open, controlled, 5-year, prospective, clinical, multi-center study. A total of 143 adult~     patients will be treated. Female or male, with an age range from 18 (or age of consent) to 70~     years, provided they fulfill the inclusion criteria and need two single tooth restorations on~     contralateral teeth in the same arch. Each patient will receive in minimum one NobelProceraTM~     Crown Shaded Zirconia and one NobelProceraTM full contour crown IPS e.max CAD in lithium~     disilicate on the 1st or 2nd molar randomly allocated to the same tooth position~     contra-laterally in the maxilla or mandible. The patients will be followed for 5 years after~     receiving their final prosthetic restorations. Possible dropouts and withdrawals, as well as~     possible adverse events, will be carefully monitored during the entire investigation period.~   "
105367|NCT02188199|"~     This study will assess the efficacy of products, implants, and procedures for knee and hip~     replacement.~   "
105372|NCT02188134|"~     Per-capita consumption of medication is higher in older adults than any other sector of the~     population. In fact, it has been estimated that although older adults comprise 13% of the~     population they take 34% of all prescriptions and 30% of the over-the-counter (OTCs) consumed~     in the US (National Council on Patient Information and Education, 2010). Given current trends~     in aging, the savings, freedom and flexibility that self-medicating provides, as well as the~     trends to switch prescription products to an OTC status, it is likely that older adults will~     increasingly turn to OTCs as part of their medical regimens for years to come (Hanlon, J et~     al, 2001).~      In addition to the advantages that self-medicating offers, there are risks. These risks are~     more pronounced in older consumers, who are likely experiencing physiological changes (e.g.~     pharmacokinetics, pharmacodynamics, perceptual, cognitive and motor); this combines with a~     propensity for poly-pharmacy that escalates the likelihood of adverse drug reactions. It has~     also been suggested that low health literacy rates in older consumers detrimentally impact~     health and health outcomes in this population (Kutner et al., 2005 and Federman et al.,~     2009).~      Despite the risks associated with improper OTC use, the critical importance of OTC labeling~     information (there is no learned intermediary), and the fact that older consumers are~     significantly more likely to experience an adverse drug reaction than younger adults,~     surprisingly little information exists about the decision making process older adults employ~     when selecting and using an OTC product.~      We propose to recruit people 65 and older for an eye tracking study of mock OTC brands. The~     study has the following objectives:~        1. To begin to garner insights regarding the proportion of subjects who closely examine~          (e.g. turn to the Drug Facts Label) the labeling of an OTC when deciding whether (or~          not) a drug is appropriate for them (based on their health history and current~          medications).~        2. To quantify and compare the attentive behaviors to specific information (Specifically:~          name, active ingredient, symptom relief).~        3. To quantify and compare the attentive behaviors to different formats of information~          (prominently featured information vs less prominently featured information).~        4. To begin to benchmark whether or not older consumers make appropriate choices based on~          their current conditions and medication history.~   "
105373|NCT02188121|"~     Patients with severe mental illness (SMI) die younger than persons in the general population.~     Much of the excess mortality for SMI patients is attributable to cardiovascular disease, and~     is exacerbated by treatment with second-generation antipsychotics (2GAs). Although the~     cardiovascular risks are well-known, and safe, efficacious therapy exists, few SMI patients~     receive cardiovascular prevention drugs. Care delivery fragmentation and poor patient~     adherence are central problems to reducing cardiovascular risks for patients with SMI. To~     address these problems, we propose to conduct a multi-site, open-label, randomized controlled~     trial comparing an initial treatment strategy of free, fixed-doses of two generic,~     cardiovascular prevention drugs (statins and angiotensin drugs) delivered within mental~     health clinics versus usual treatment. The study will include adult patients (18+ years old)~     with schizophrenia, schizoaffective disorder, bipolar disorder, major depressive disorder, or~     psychosis not otherwise specified (NOS) who have received 2GAs treatment within the past six~     months from within four mental health clinics in the Boston area. We have three aims: 1) to~     compare the proportions of subjects in each arm who are receiving cardiovascular drug~     treatment and are adherent to therapy during 12-months of follow-up; 2) to compare changes in~     composite (e.g., Framingham scores) and individual (e.g., lipid levels) cardiovascular risk~     factor levels using an intent-to-treat (ITT) approach; and 3) to compare risk factor levels,~     accounting for variation in adherence over time, using causal inference techniques to~     estimate the per-protocol effect of the intervention. Our three aims examine whether this low~     cost, streamlined treatment strategy increases the numbers of subjects receiving~     cardiovascular prevention therapy and improves cardiovascular risk levels. We will follow~     subjects for 12 months, and collect interview and biometric data at baseline and over the~     following 12 months. Subjects will have the option to continue for another 12 months, during~     which we will continue to collect interview and biometric data, but will not prescribe~     cardiovascular medications. This population-based initial treatment strategy could be an~     effective and efficient approach for overcoming traditional barriers to cardiovascular~     disease prevention within the SMI population. Findings from this study will inform efforts to~     improve care and outcomes, and to enhance survival for patients with severe mental illness.~   "
105374|NCT02188108|"~     The overall purpose of this study is to evaluate criterion-related validity of a~     newly-developed disease-specific instrument to assess the health-related quality of life~     (HRQOL) of patients who have had kidney stones. Specific aims of this study are:~        1. Aim 1. Evaluate the population/external validity (generalizability) of the Wisconsin~          Stone-QOL by answering the question, Is the Wisconsin Stone-QOL useful for assessing~          the HRQOL of patients who form kidney stones from a broad region of North America?~        2. Aim 2. Assess the ability of the Wisconsin Stone-QOL to detect changes within patients~          related to stone interventions and other disease-specific outcomes by answering the~          question, Is the Wisconsin Stone-QOL sensitive to changes in stone-related outcomes~          within individuals?~   "
105375|NCT02188095|"~     Clinical and radiological 3 year results of Excia T® Hip Stem~   "
105376|NCT02188082|"~     Ivabradine acts by inhibiting the ionic If current that modulates the pacemaker activity of~     sinoatrial node cells. The aim of present study is to evaluate the efficacy and safety of~     IvabRadine hemisulfate Sustained-release Tablets versus placebo in patients with moderate to~     severe chronic systolic heart failure.~   "
105377|NCT02188069|"~     SCAD (Spontaneous coronary artery dissection - tear in the arterial wall that is not related~     to trauma) is an under-diagnosed and poorly understood condition that mostly affects young~     women without common cardiovascular risk factors, and can result in heart attack and death.~     This observational study is designed to capture the disease's natural history and~     predisposing arteriopathies (medical conditions resulting in changes in the arteries),~     treatment strategies, long-term cardiovascular outcomes. It will also improve the diagnosis~     of SCAD on coronary angiography by participating clinicians, and provide guidance on~     investigating predisposing conditions.~   "
105378|NCT02188056|"~     Patients with an episode of VTE (DVT and / or PE) have a mortality rate of 16-21% at 1 year~     after diagnosis. Morbidity associated with VTE is marked by the risk of recurrence, estimated~     at 30% and estimated at 29% after 8 years of follow post-thrombotic syndrome. For a number of~     these patients, risk factors have been identified (congenital or acquired thrombophilia,~     cancer, postpartum, surgery, prolonged immobilization, etc..). In 25-50% of cases, the~     etiology remains unknown, justifying the need for well-conducted studies to determine other~     potential risk factors. In addition, the expansion of treatment options with the arrival on~     the market of new direct oral anticoagulants, allows comparative studies on the effectiveness~     and frequency of adverse events for each treatment.~   "
105379|NCT02188043|"~     The purpose of this study is to evaluate the Relay Model helping alcohol dependent patients~     at a general hospital to start specialized alcohol treatment in order to assess i) efficacy,~     ii) cost-effectiveness and iii) overall societal cost impacts.~      The effect of the Relay Model will be investigated in a single-blind pragmatic randomised~     controlled trial in which the control group consists of patients referred to treatment by~     usual procedures.~   "
105380|NCT02188030|"~     This study is double-blinded RCT, whose aim is to assess if an individual exercise program is~     more effective to reduce complaints in neck, shoulders and arms that an group exercise~     program, in industrial workers.~      The participants will be randomly allocated to receive 12 treatment sessions of individual~     exercise training (IET) or in group exercise training (GET). Sessions will last 30 minutes~     and will be held twice a week for 12 weeks. Participants will also be encouraged to continue~     the use of medicines and other health care.~   "
105381|NCT02188017|"~     An randomized trial of two maintenance doses of Acthar Gel for patients with chronic~     pulmonary sarcoidosis. Patients will be observed for 24 weeks of treatment.~   "
105447|NCT02187146|"~     The purpose of this study is to investigate whether an association exists between serum~     vitamin D levels and IVF treatment outcome~   "
105383|NCT02187991|"~     The goal of this clinical research study is to learn if the study drug, alisertib, in~     combination with chemotherapy (paclitaxel), can shrink or slow tumor growth in women with~     hormone receptor (HR)-positive, HER2-negative or HR-negative, HER2-negative (triple negative)~     locally recurrent or metastatic breast cancer. The safety of alisertib in combination with~     paclitaxel will also be studied. The physical state of the patient, symptoms, changes in the~     size of the tumor, and laboratory findings obtained while on-study will help the research~     team decide if alisertib plus paclitaxel is safe and effective in patients with this type of~     breast cancer.~      Alisertib belongs to a group of drugs called Aurora kinase inhibitors. Alisertib blocks the~     activity of Aurora A kinase, a protein that is involved in tumor cell multiplication and~     survival. Aurora A kinase is expressed at higher than normal levels in many types of cancer,~     including breast cancer, and preclinical studies suggest that blocking the activity of this~     protein can lead to the death of cancer cells.~      Paclitaxel is a chemotherapy drug commonly used to treat many different kinds of cancer,~     including metastatic breast cancer. The reason to combine alisertib and paclitaxel is that in~     cancer therapy, combinations of drugs are often more effective as a treatment than either of~     the same drugs used alone.~   "
105384|NCT02187978|"~     The purpose of this study is to compare the effect of early total oral feeding versus~     conventional oral feeding in stable VLBW infants. In current clinical practice, the~     introduction of oral feeds for VLBW infants is often preceded by a period of fasting or~     minimal feeding because of fear of necrotizing enterocolitis (NEC). However, this may be~     associated with potential disadvantages and increased infectious and metabolic complications~     related to prolonged fasting and use of parenteral nutrition. The studies conducted till date~     have shown better outcomes and improved postnatal growth with early initiation and fast~     advancements of feeds. It is still unclear whether stable VLBW babies can tolerate total oral~     feeds on day 1 of life. No such study has been conducted on early total oral feeding but~     observational work in our unit has shown it to be safe without any increased incidence of~     feed intolerance or NEC. In view of the uncertainties regarding feeding protocols in VLBW~     infants all over the world, the investigators decided to assess the effect of early total~     enteral feeding in stable VLBW infants.~   "
105385|NCT02187965|"~     Subjects were asked to come to the Purdue facilities after an overnight fast on 2 different~     testing days for 2.5 hours each day. On one day the subjects participated in blood pressure~     and body weight measurements as well as a muscle biopsy from the thigh. On the second day the~     subjects underwent an MRI and MRS scan of the thigh and calf.~   "
105386|NCT02187952|"~     The primary objective of the proposed study is to determine whether behavioral feeding~     intervention impacts mother-child attachment in infants and toddlers with feeding problems.~     The investigators propose the following hypotheses:~        -  Behavioral feeding intervention will not significantly impact parent-child attachment.~        -  Behavioral feeding intervention will not significantly impact parent-child unstructured~          play interactions.~        -  Severity of feeding problems will decrease after behavioral feeding intervention is~          implemented.~        -  Behavioral feeding intervention will have either no significant effect or a significant~          positive effect on general child behavior.~   "
105387|NCT02187939|"~     Get in the GROOVE! will address health disparities impacting underserved youth. Given the~     alarming rate of overweight and obesity among high school minority youth, the project will~     focus on middle school with the primary aim of reaching middle school girls before unhealthy~     habits become firmly ingrained.~      The primary aim of the research project is to investigate the impact of two types of summer~     science enrichment programs (that focus on health and wellness) on middle school girls'~     self-efficacy, health knowledge, health behaviors, and interest in science. One program will~     present the curriculum by conventional means (GROOVE condition) while the second program will~     include the addition of a closed 3-D virtual world environment to reinforce concepts (GROOVE+~     condition).~      The following hypotheses will be tested in the randomized controlled trial:~        1. Upon completion of the summer program, the enhanced summer program GROOVE+ relative to~          the conventional summer program will result in a) increased self-efficacy for adopting~          healthy behavior change; b) increased health knowledge; c) enhanced science~          self-concept; and e) more positive behavior change (e.g., improved nutrition, increased~          physical activity).~        2. At follow-up, the enhanced summer program relative to the conventional summer program~          will result in further and/or sustained improvements in positive behavior health~          behaviors and attitudes.~   "
105388|NCT02187926|"~     The purpose of this study was to examine the characteristics of patients selected for~     treatment with roflumilast and the effectiveness and safety of roflumilast in patients with~     severe or very severe COPD treated in Hospital and outpatient specialist ward settings in~     Greece.~   "
105389|NCT02187913|"~     -  About two-thirds of adults in the United States are overweight or obese which can cause~          adverse health consequences for those individuals. Post-prandial hyperglycemia is one of~          these possible consequences and is associated with a higher risk for Type 2 Diabetes.~          Controlling hyperglycemia is important in the prevention of the onset of diabetes and~          obesity. Resistant starch is a dietary carbohydrate which is not completely digested in~          the gut and produces energy for the body to use. The investigators are interested in~          assessing the effects of resistant starch on postprandial blood glucose and insulin~          concentrations.~        -  Aim: To assess the effects of a resistant starch on post-prandial blood glucose and~          insulin concentrations.~        -  Hypothesis: A baked snack bar with a resistant starch will blunt and sustain the~          post-prandial rise in blood glucose and insulin concentrations compared to a baked snack~          bar with maltodextrin (an easily digested carbohydrate).~   "
105390|NCT02187900|"~     The purpose of this study is to determine whether Multi-glycoside of Tripterygium Wilfordii~     HOOK. f. is effective and safe in the treatment of IgA nephropathy.~   "
105492|NCT02186561|"~     The purpose of this study is to assess the safety and effectiveness of the Pipeline™ device~     in the treatment of unruptured, wide-neck intracranial aneurysms.~   "
105717|NCT02183636|"~     Determination of the relative bioavailability of 2 different formulations of a 5 mg~     linagliptin (BI 1356)/45 mg pioglitazone fixed dose combination (FDC) tablet, formulation C5~     and formulation C8, compared with the mono-components linagliptin and pioglitazone~     administered together~   "
113706|NCT02079116|"~     This study aims to determine changes in cerebral blood flow of people with obesity after the~     ingestion of fat.~   "
105391|NCT02187887|"~     The primary objective of the research study is to test the feasibility of a brief~     Internet-based intervention to reduce heavy alcohol use among young adult veterans of wars in~     Iraq and Afghanistan. Veterans are recruited through the social media website Facebook in two~     phases. In the first phase, investigators collect data from 800 veteran participants to~     document and analyze drinking norms in this population. In the second phase, investigators~     use the norms collected in Phase 1 and information from the analyses to develop and pilot~     test an online intervention with young adult veteran participants. Six hundred participants~     are recruited through Facebook and randomly assigned to intervention (N = 300) or control (N~     = 300) conditions. It is hypothesized that those in the intervention condition will drink~     less at a one-month follow-up period than those in the control condition. Investigators also~     collect feedback from participants on the usability of the online intervention.~   "
105392|NCT02187874|"~     Early cord clamping after delivery has been common practice for many decades as part of the~     active management of the third stage of labour. However in recent years, several studies have~     shown that delayed cord clamping may offer important benefits to the newborn. The data~     gathered indicate that delayed cord clamping may be particularly useful in premature babies,~     between 26 and 32 weeks of gestational age, reducing the need for blood transfusion and the~     incidence of intraventricular haemorrhage.~      However it is argued that the described potential benefits of delayed cord clamping could be~     negated by the increased risk of polycythaemia and jaundice in the newborn, as well as by~     potential interference with the postpartum haemorrhage management, initial care and~     reanimation of the premature newborn, and the possibility of cord blood donation. These~     factors, together with as the lack of homogeneity among existing studies regarding the~     delayed cord clamping technique create the need, in our opinion, for further research, to~     establish the proper place of this measure.~      Our hypothesis is that delayed cord clamping in the premature newborn significatively reduces~     the need for blood transfusions and intraventricular haemorrhage, compared with usual early~     cord clamping.~      Secondary outcomes:~        -  To define the impact of delayed cord clamping on neonatal assessment parameters after~          delivery: APGAR score, cord pH, need for mechanical ventilation or reanimation.~        -  Neonatal mortality and morbidity~        -  Effect of the procedure on the incidence and severity of maternal postpartum haemorrhage~        -  To study the correlation between Iron metabolism and reticulocitary haemoglobin levels~          in cord and infant blood.~   "
105393|NCT02187861|"~     This open-label, international, multicenter study will investigate the safety and efficacy of~     venetoclax (GDC-0199) in combination with bendamustine plus rituximab (venetoclax + BR)~     compared with BR alone in participants with relapsed and refractory fNHL, comparing two~     chemotherapy-containing regimens (Chemotherapy-Containing Cohort). In addition, an~     exploratory analysis of the safety and efficacy of venetoclax in combination with rituximab~     (venetoclax + rituximab), a chemotherapy-free regimen, will be performed (Chemotherapy-Free~     Cohort). Assignment to the Chemotherapy-Containing or Chemotherapy-Free Cohort will be~     decided at the discretion of the Investigator, unless one of the cohorts is not open to~     enrollment; in which case, participants may be enrolled only to the open cohort. The first 6~     participants enrolled in the Chemotherapy-Containing Cohort (or more if required) will~     comprise the Safety Run-In group for Treatment Arm B, dosing venetoclax at 600 milligrams~     (mg) in combination with BR. Once a dose has been chosen from the Safety Run-In Period,~     randomization to the two treatment arms of the Chemotherapy-Containing Cohort (Arms B and C)~     will begin.~   "
105394|NCT02187848|"~     Primary Objectives:~        -  To determine the maximum tolerated dose (MTD) of SAR408701 administered as monotherapy,~          once every 2 weeks (with and without a loading dose at Cycle 1) to patients with~          advanced solid tumors (Escalation Phase).~        -  To assess efficacy according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST~          1.1) (Expansion Phase) when SAR408701 is administered once every 2 weeks with or without~          a loading dose at Cycle 1.~      Secondary Objectives:~        -  To characterize the overall safety profile of SAR408701.~        -  To characterize the pharmacokinetic (PK) profile of SAR408701 and of its potential~          circulating derivatives.~        -  To identify the recommended phase 2 dose (RP2D) of SAR408701.~        -  To assess the potential immunogenicity of SAR408701.~   "
105395|NCT02187835|"~     Aim was to detect EEG complexity in a specific group of patients to contribute to the~     discussion whether schizophrenia is associated with increased or decreased complexity. We~     included the EEG recordings of patients with a diagnosis of schizophrenia. We hypothesized~     that chronic residual schizophrenia is characterized by decreased complexity in EEG.~   "
105396|NCT02187822|"~     The main purpose of this study is to see whether addition of TPI 287 to FSRT is safe and~     tolerable. Researchers also want to find out if adding TPI 287 to FSRT can help with better~     controlling the growth of brain lesions in people with brain metastases from their cancer.~   "
105397|NCT02187809|"~     To investigate the long-term safety and tolerability of clobazam when administered for 1 year~     as adjunctive therapy in paediatric patients aged ≥1 to ≤16 years with Dravet Syndrome.~   "
105398|NCT02187796|"~     1. To determine, in the Quillen College of Medicine HIV+ outpatient clinic, the prevalence~          of~             -  NC (normal cognition )~             -  ANI (asymptomatic neurocognitive impairment )~             -  MCD (mild cognitive disorder )~             -  HAD (HIV-associated dementia )~        2. To determine whether the following variables affect the three categories of HAND~             -  Time since first diagnosis of HIV infection~             -  Anti-viral medications used~             -  Age~             -  Gender~   "
105399|NCT02187783|"~     The purpose of this signal seeking study is to determine whether treatment with LEE011~     demonstrates sufficient efficacy in CDK4/6 pathway activated solid tumors and/or hematologic~     malignancies to warrant further study.~   "
105400|NCT02187770|"~     The purpose of this study is to determine if IMED-4 recordings have sufficient precision to~     detect a clinically significant change in lung fluid status in acute heart failure syndrome~     with pulmonary congestion.~   "
105401|NCT02187757|"~     Study to evaluate Efficacy and Safety of PreLipid® on subjects with higher than normal blood~     lipid levels~   "
105718|NCT02183623|"~     Investigation of the multiple dose pharmacokinetics, safety and tolerability of simvastatin~     and simvastatin acid with and without concomitant administration of BI 1356 BS~   "
129283|NCT01875172|"~     The purpose of this study is to determine whether bupropion SR increases cessation and/or~     smoking reduction among pregnant smokers.~   "
105403|NCT02187731|"~     The FULIMA study is a two-center study at Odense University Hospital and Vejle Hospital,~     Denmark. The primary objective is to identify the optimal imaging technique for studies in~     multiple myeloma with focus on PET/CT and MRI.~      By combining early (1 hour) and late (3 hours) 18F-2-fluoro-2-deoxy-D-~     fluorodeoxyglucose(18F-FDG)-PET/CT scans the investigators expect to see increased uptake of~     radioactive tracer and thus an improved ability to identify malignant tissue. A second tracer~     18F-natrium-fluoride is used to explore early signs of bone remodeling. By using new software~     (ROVER) for interpreting PET data the investigators expect to obtain a quantitative~     measurement of total disease burden with less risk of misinterpretation of data.~      Diffusion weighted MRI (DWI) is a new MRI technique which, like PET/CT, makes it possible~     quantitatively to calculate the overall disease activity and to give an early evaluation of~     response to chemotherapy. The study examines DWI for development and standardization.~      To validate imaging findings and to explore the pathogenetic heterogeneity of multiple~     myeloma, the investigators perform CT guided biopsies from PET/ DWI positive sites.~     Pathoanatomical and immunohistochemical findings and gene expression data from positive sites~     are compared to random bone marrow. The question is whether disease heterogeneity may explain~     the lack of FDG uptake in bone marrow in some patients? To the extent that the FULIMA study~     produces useful data, the defined and standardized imaging techniques will form the basis of~     a larger prospective study at national level in Denmark.~   "
105404|NCT02187718|"~     Rationale: In breast cancer (BC) patients, lymph node status is a key prognostic indicator.~     At present, axillary ultrasound (US) with subsequent fine needle aspiration cytology (FNAC)~     of suspicious lymph nodes (US+FNAC) is widely used as a pre-operative staging method. When~     US+FNAC is negative, a sentinel node procedure (SNP) is performed during breast surgery.~     Nowadays, an axillary lymph node dissection (ALND) is generally performed if one of the~     abovementioned diagnostic entities reveals lymph node metastases. However, the extensive role~     of ALND in BC patients with lymph node metastases may change or diminish in upcoming years~     due to emerging evidence that completion ALND (cALND) does not affect disease-free survival~     and overall survival in early BC patients with (sentinel) node-positive disease. Whether ALND~     is needed in these patients, should be based on (axillary) tumour load. Because of the fact~     that tumour load can only be reliably evaluated by SNP and not by US+FNAC, the role of SNP~     might become even more important in upcoming years.~      Ideally, the status of this sentinel lymph node is known prior to breast surgery, so a~     patient tailored treatment plan can be made and discussed with the patient before breast~     surgery. In this context, it would be very logical to perform a SNP under local anaesthesia~     (LA), prior to breast surgery. This might not only lead to significantly less two-step~     surgical procedures under general anaesthesia (GA), but might also lead to a reduction of~     depressive symptoms and anxiety and improved quality of life (QoL) of BC patients, because BC~     patients are in particular risk for psychological distress in the first three months after~     diagnosis of BC. Knowing lymph node status and the complete treatment plan as soon as~     possible (by performing a SNP under LA), might reduce this psychological distress. To~     investigate which BC patients would benefit most from SNP under LA, the investigators~     recently analysed 1132 BC patients retrospectively. Both prevalence of axillary lymph node~     metastases and prevalence of false negative results of US+FNAC were directly associated with~     age <60 years and with primary breast tumour size >20 mm. Hence, these BC patients might~     benefit most from SNP under LA. In the present study, the value of SNP under LA in these BC~     patients (i.e. <60 years with a breast carcinoma >20 mm) will be analysed.~      Objectives: Reduction of the mean number of operations under general anaesthesia per patient.~     Improvement of QoL. Reduction of depressive symptoms and experienced anxiety.~      Study design: Prospective single centre randomised controlled clinical trial. Study~     population: Women aged 18 to 60 years who are diagnosed with BC AND with a tumour size of >20~     mm ultrasonographically AND with a negative or inconclusive pre-operative US+FNAC.~      Intervention: Sentinel Node Procedure under Local Anaesthesia (SNP under LA) Control:~     Traditional Sentinel Node Procedure under General Anaesthesia (SNP under GA) Main study~     parameters: Primary outcome parameters are the number of operations under GA per patient and~     the number of operations under LA per patient. Secondary outcome parameters are QoL,~     experienced depressive symptoms and anxiety.~      Timeline and statistics: The inclusion period will be conducted from the 1st of July 2014 to~     the 1st of August 2015, and 80 patients will be enrolled in this study (alpha 0.05; power~     0.8). Inclusion of 80 patients will be sufficient to reduce the number of two-stage surgical~     procedures under general anaesthesia with 30%. Data will be analysed using descriptive~     statistics, Chi-squared test, Fisher's exact test, Mann-Whitney U test, Kruskall-Wallis test,~     students t-test, ANOVA, paired t-test, Wilcoxon signed-rank test, Friedman test, Pearson's~     and Spearman's rank correlation coefficients and finally logistic and linear regression~     analysis.~   "
105405|NCT02187705|"~     The aim of this observational study was to supplement the data on efficacy, safety, and~     tolerability of telmisartan under daily conditions in hospitals~   "
105406|NCT02187692|"~     The aim of the study is to compare the effectiveness of the meta-cognitive training (MCT) for~     schizophrenia against treatment as usual (TAU) among patients who attends community support~     groups. 4 weeks of MCT will be administered for patients two times per week. MCT consists of~     well structured cognitive behavioral therapy interventions. MCT will be administered~     according authors recommendations. All participants will be assessed at baseline (T0) and up~     to one week after the MCT intervention (T1, 4-5 week of the study).~   "
105407|NCT02187679|"~     Our intervention will be the injection of Abobotulinum toxin A into the affected site/vocal~     cords for patients with the diagnosis of Primary Tourette's syndrome. This is an efficacy~     trial to understand the right dosage of Abobotulinum toxin A which can be affective. The~     study will involve an injection of 2.5 units of Dysport on each side of the affected vocal~     cords for patients with a diagnosis of Primary Tourette's syndrome. The patients will also~     complete a self assessment survey on how vocal tics affect their daily lives. Afterward, a~     further evaluation of the tics will be conducted by the investigator using the Yale Global~     Tic Severity Scale. (YGTSS) evaluation. How this will be done is by a licensed ENT (Ear, Nose~     and Throat) physician. The windpipe will be number by a 2% lidocaine followed by a provoked~     cough by the patient. This will allow the lidocaine to be sprayed throughout the airway~     preventing coughing and swallowing during the procedure. An Electromyography (EMG) guidance a~     needle containing Dysport will be injected into the thyroarytenoid muscles will potentially~     reduce the vocal dyskinetic features in patients with TS. This needle will be connected to a~     syringe and once determined active, it will be placed appropriately when the EMG emits a~     characteristic sound. If this does not occur with the patient then the injection will be~     administered under direct vision via direct laryngoscopy using an orotracheal injector~     system.~      This procedure is conducted in an outpatient clinic because no hospitalization is required.~     The patient is not allowed to consume food or drink for about 45-60 minutes after the~     injection. The throat will be numb and may cause coughing and some blood tinged sputum: The~     expectancy of this outcome is reason to not consider is a serious event. Asprin and ibuprofen~     is not allowed a week prior to and until the injection at least 3-4 days after to prevent~     excessive bleeding. The patient is also instructed to ensure that they chew their food~     thoroughly and drink sufficient water for the initial days after the study intervention. Mild~     dysphasia may be noted initially which should resolve within a few hours. On Visit 1, the~     patient will complete all required study documents and forms. Then the ENT physician will~     proceed with the injection Dysport on the same day. If unforeseen circumstances render the~     subject unable to be injected on the same day, the intervention must take place within three~     days and this will be considered V1, follow up events should be scheduled accordingly.~   "
105408|NCT02187666|"~     The primary objective of the Spine Registry is to enhance the understanding of spinal disease~     and treatment of spinal disease with the goal of guiding treatment options.~   "
105409|NCT02187653|"~     The primary objective of this study is to evaluate the rate of new or worsening neurologic~     deficits and/or radiculopathy following lumbar or cervical surgery in light of IOM using~     neurological testing (motor and sensory) in the optimal management of the surgical patient.~   "
105410|NCT02187640|"~     This study is to evaluate the effects of self-administered acupressure therapy for~     psychiatric in-patients with constipation~      Two main research questions include:~        1. What are the effects of the standardized self-administered acupressure program on~          reducing those adult psychiatric patients' symptoms of constipation?~        2. What are the psychiatric patients' (participants') perceived benefits and limitations of~          self-administered acupressure on management of their constipation?~      In this study, the participants who met the study criteria and completed the baseline~     measurement would be randomly assigned into either the self-administered acupressure program,~     or a sham control group who receive a placebo, non-acupoint pressure. The null hypotheses of~     this study are:~        1. There is no significant difference between the acupressure and sham group immediately~          and/or two weeks after the completion of intervention on patients' symptom severity of~          constipation; and~        2. There is no significant difference between the acupressure and sham group on patients'~          perceived quality of life at immediately and two weeks after treatment completion.~   "
105411|NCT02187627|"~     This study is designed to obtain basic information on three PET imaging tracers developed to~     detect tau pathology in the brain. In this study, healthy control participants and~     participants with AD will be studied. Information collected will include brain and plasma~     kinetics, tissue distribution (in the brain), radiation dosimetry, and test-retest~     variability of the signal in the brain. The study will consist of Part 1, Part 2A, and Part~     2B. During Part 1, imaging data will be assessed on an ongoing basis and based on data, one~     tracer will be prioritized over the other two tracers. The tracer selected will be further~     investigated in Part 2A and Part 2B.~   "
105448|NCT02187133|"~     This study will be conducted as a Phase Ib, open-label, non-randomized, single-institution~     study to evaluate the safety and tolerability of carfilzomib in combination with bendamustine~     and rituximab in patients with relapsed or refractory NHL and to determine the recommended~     phase II dose and preliminary efficacy of this combination. The study will have two phases: a~     dose-escalation phase to determine the maximal tolerated dose of carfilzomib in this~     combination where participants will be monitored for toxicity, tolerability and response and~     a dose-expansion phase that will determine the preliminary efficacy in patients with Mantle~     cell lymphoma or any other disease subtype in which there is a preliminary efficacy signal~     observed.~   "
105412|NCT02187614|"~     Abdominal pain is one of the most common presentations to an emergency department (ED). Among~     patients presenting with abdominal pain, a common diagnosis in the Middle East is renal colic~     (urolithiasis or Kidney stones). As the patients with renal colic writhe around in agonizing~     pain, the first priority in an ED from a patient's perspective is fast and safe analgesia and~     to be pain free as early as possible. There are variations in physician preference to choose~     initial analgesic drug for managing such pain. Commonly used drugs are:~        -  Opioids such as Morphine or Fentanyl~        -  Non steroidal drugs such as Diclofenac, Ketorolac or Brufen~        -  and Paracetamol intravenous injection.~      A robust evidence in comparison of diclofenac versus morphine and paracetamol is lacking.~     This study is design to obtain data on efficacy of these three drugs within 30 minutes in a~     non inferiority trail.~   "
105413|NCT02187601|"~     The aim of the study is to confirm that the new generation state of the art breath analyzer~     gives equivalent results to the previous model of the Exalenz breath analyzer.~   "
105414|NCT02187588|"~     Study to determine the kinetic of the analgesic effect of 500 mg and 1000 mg of Eschscholtzia~     Californica per os and placebo in patients undergoing dental surgery over an observation~     period of 6 hours. In a secondary analysis, kinetic of analgesic effect comparison between~     Eschscholtzia californica 500 mg, 1000 mg and Ibuprofen 200 mg~   "
105415|NCT02187575|"~     Study to investigate the bioequivalence between 10 mg tablets (test drug) and 10 mg capsules~     (reference drug) of meloxicam (UHAC 62 XX) after 7-day administration.~   "
105416|NCT02187562|"~     The objective of this study was to investigate the influence of meloxicam on low dose aspirin~     induced inhibition of platelet aggregation and thromboxane B2, when meloxicam is given before~     aspirin.~   "
105417|NCT02187549|"~     The purpose of this study is to determine whether intra-articular hyaluronic acid provides~     symptomatic relief of osteoarthritis of the knee.~   "
105418|NCT02187536|"~     To assess the pharmacokinetics of simvastatin and simvastatin acid with/without concomitant~     administration of telmisartan~   "
105419|NCT02187523|"~     A study to demonstrate the bioequivalence of telmisartan and HCTZ administered as fixed dose~     combination in comparison to the single unit formulations~   "
105420|NCT02187510|"~     The purpose of this study is to determine whether the umbilical cord milking in preterm~     infants born by cesarian section less than 34 weeks is more effective than delayed cord~     clamping to obtain higher levels of hemoglobin.~   "
105421|NCT02187497|"~     The pharmacokinetic profile of BIBR 277 single dose given in capsule form to hypertensives~     was evaluated. The results of the present study are to be used in the Japanese population~     pharmacokinetics analysis~   "
105422|NCT02187484|"~     The antihypertensive effect, safety and usefulness of treatment with BIBR 277 capsules were~     evaluated in hypertensive patients with nephropathy~   "
105423|NCT02187471|"~     The main objective of this trial is to compare change in weekly average daily pain score~     (ADPS) from baseline to Week 13 in participants receiving either dose of DS-5565 versus~     placebo.~      Weekly ADPS is based on daily pain scores reported by the subject that best describes his or~     her worst pain over the previous 24 hours.~   "
105424|NCT02187445|"~     Acute and chronic pulmonary complications with concomitant inflammatory response are a~     leading cause of morbidity and mortality in children with sickle cell disease (SCD). Acute~     chest syndrome (ACS), defined broadly as an increase in respiratory effort, fever and new~     radiodensity on chest x-ray, is a major cause of death in children and adults with SCD. There~     is a high rate of ACS in children between 1 and 4 years of age that is associated with an~     asthma diagnosis, and children with ACS events before 4 years of age have a 50% rate of being~     hospitalized for either ACS or pain within 1 year of admission. For children with SCD that~     develop ACS, the investigators propose that the use of budesonide inhalation suspension (BIS)~     will attenuate pulmonary inflammation after an ACS episode and will decrease future~     vaso-occlusive pain and ACS episodes. Through a single-arm prospective feasibility trial and~     in preparation for a limited-institution randomized trial, the investigators plan to test the~     following primary hypothesis for a phase III definitive trial: In children with SCD admitted~     to the hospital for an ACS episode between 1 and 4 years of age, low dose BIS for 6 months~     will result in a 50% reduction in the recurrent incidence rate of ACS or pain requiring~     hospitalization. Through this trial, the investigators will determine the acceptability of~     and adherence to BIS in the study population. The investigators will track respiratory~     symptoms in cases versus controls over 6 months. Finally, the investigators will explore the~     impact of BIS on biological correlates (sVCAM-1).~   "
105425|NCT02187432|"~     EuroCYST initiative aims to build a large, well-characterized cohort of Autosomal Dominant~     polyCYSTic Kidney Disease (ADPKD) subjects who are followed in a longitudinal observational~     cohort study has the potential to identify progression factors and biomarkers, and to assess~     disease stage specific mortality, morbidity and health care costs.~   "
105426|NCT02187419|"~     The purpose of this study is to determine feasibility and adherence to a hypnosis program to~     improve sleep. It is theorized (based on prior experience and pilot data) that one or more~     hypnosis program(s) will be feasible and will exhibit acceptable adherence. The programs will~     assess to determine optimal dose (3 vs 5 sessions) and method (audio-recorded vs therapist~     delivered).~   "
105427|NCT02187406|"~     Identify, quantify and compare the fatigue caused in two ankle athletic tapes after the~     completion of a tennis warm-up.~   "
105428|NCT02187393|"~     The investigators are trying to understand the role of specific genes in the function of~     airway surface cells. The investigators know that there are some common genetic markers that~     are associated with various lung diseases. However, most people with these genetic markers~     never develop any evidence of lung disease, so it is not understand how or if these markers~     play a role in disease. Investigators are asking healthy people to provide three (3) tubes of~     blood as well as a sample of cells from their nose. Investigators will use the blood sample~     to provide genetic information (specifically, presence or absence of alleles known to be~     associated with pulmonary fibrosis). Nose cells from individuals with the genetic markers~     that investigators are studying will be grown in the the lab to allow investigators to learn~     more about how the cells respond to various forms of environmental stress, such as exposure~     to cigarette smoke. The goal of this study is to understand how specific genes affect airway~     cell function.~   "
105429|NCT02187380|"~     The objective of the SIMCA study was to analyse the impact of structured medication~     counselling by community pharmacists on medication adherence, economic, clinical and~     humanistic outcomes of depressed primary care patients who started a new treatment with~     antidepressants.~      A clustered RCT was set up in the Surplus Network, a pharmacy chain in Flanders, Belgium. At~     the time of the start of the study, the Surplus Network included 97 pharmacies, in all five~     Flemish provinces, including Brussels. During pre-trial meetings, all pharmacists were~     informed about the SIMCA-study and instructed how to approach eligible patients.~      Randomisation was obtained at the pharmacy level by a computerized random-number generator,~     following a permuted block design (1:1). The Surplus Network contains a number of local~     pharmacy chains; stratiﬁcation was used to ensure equal distribution within local pharmacy~     chains.~      Pharmacists in the intervention group were trained in communication skills related to~     depression treatment counselling in groups of no more than 10 participants over a single day.~     In total, 10 training days were scheduled between November and December, 2010.~      Patients were eligible for inclusion in the study if they started using at least one~     antidepressant drug, if they were at least 18 years old, if they were able to understand and~     complete Dutch questionnaires and if they could be reached by telephone for follow-up.~     Starting was defined as not having been prescribed antidepressants over the last six~     months, which was checked in the pharmacy records. If the patient gave verbal consent to the~     pharmacist, to be contacted by the research team, the patient was provided with written and~     oral information about the SIMCA project and a consent form. At the same time an automatic~     e-mail was generated from the pharmacy software to inform the research team about the~     patient's willingness to be contacted about the study. The patient was contacted by the~     research team, as soon as possible to give more information about the study, to ask for~     informed consent and to schedule a first telephone survey interview. If the patient wished to~     participate, he/she completed the consent form, and sent it back with the included~     postage-paid envelope addressed to the research team. Upon receipt of the consent form, the~     recruited patient's prescribing doctor was contacted and asked to complete and return a brief~     questionnaire to provide the diagnosis and its severity related to prescribing~     antidepressants.~      Telephone survey interviews based on validated scales were used to collect data at the start~     of treatment (as close as possible to the time of recruitment), after one month, three months~     and six months of treatment.~   "
105430|NCT02187367|"~     The vaccine contains humanized recombinant antigen (EGF - Epithelial Growth Factor) and an~     adjuvant. The antibodies induced by vaccination will react with circulating EGF leading to~     removal of EGF from the circulation. As a result, binding to its target EGF-Receptor is~     prevented. Blocking of EGF-Receptor is preventing activation and stimulation of proliferation~     of tumour cell. A Phase 3 clinical trial on the EGF vaccine is ongoing in Cuba. The result~     from previous studies demonstrated positive correlation between extended survival and immune~     response against the vaccination in the late-stage NSCLC patients' age below 60 with improved~     quality of life. The purpose of this international Phase 3 trial is to determine whether the~     recombinant human EGF cancer vaccine is safe, immunogenic and effective in the treatment of~     stage IV NSCLC patients who are positive in the selective EGF biomarker and wild type~     EGF-Receptor compared to standard treatment and supportive care.~   "
105431|NCT02187354|"~     Primary Objective:~      To estimate the incidence of treatment-emergent and treatment-related adverse events during~     treatment with blinatumomab in pediatric and adolescent subjects with B-precursor ALL in~     second or later bone marrow relapse, in any marrow relapse after alloHSCT, or refractory to~     other treatments~      Secondary Objective(s):~      To describe key efficacy outcomes, including incidence of complete response (CR) within 2~     cycles of blinatumomab, minimal residual disease (MRD) remission within 2 cycles of~     blinatumomab, relapse free survival (RFS), overall survival (OS), incidence of alloHSCT, and~     100-day mortality after alloHSCT.~      Hypotheses:~      A formal statistical hypothesis will not be tested. The incidence of treatment-emergent and~     treatment-related adverse events will be estimated.~      Study Endpoints:~        -  Incidence of treatment-emergent and treatment-related adverse events~        -  Incidence of CR within 2 cycles of blinatumomab~        -  MRD remission within 2 cycles of blinatumomab~        -  RFS~        -  OS~        -  Incidence of alloHSCT~        -  100-day mortality after alloHSCT~      Study Design:~      Multi-center, open-label, single-arm expanded access protocol~   "
105432|NCT02187341|"~     It has been shown that 5-HTP stimulates cortisol levels in plasma and saliva. Similarly, it~     has been shown that intense exercise stimulates an increase in plasma and salivary cortisol~     levels. The purpose of this study is to examine the combined effects of 5-HTP + intense~     exercise on plasma and salivary cortisol levels.~   "
105433|NCT02187328|"~     The purpose of this study is to determine whether grapefruit juice alters the metabolism of~     cortisol following intense exercise.~   "
105434|NCT02187315|"~     Comparing induction chemotherapy followed by cisplatin chrono-chemotherapy concurrent~     combined with intensity-modulated radiation therapy (chrono-chemotherapy group) with~     induction chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with~     intensity-modulated radiation therapy (routine-chemotherapy group) in the treatment of~     locally advanced nasopharyngeal carcinoma, observing the adverse reaction and effects of two~     groups,expected chrono-chemotherapy group can achieve lower toxicity, improve the curative~     effect, for the treatment of nasopharyngeal carcinoma provides a more reasonable way.~   "
105435|NCT02187302|"~     This study to evaluate treatment in patients with metastatic renal cell carcinoma (RCC) which~     has progressed through 2 to 3 prior lines of therapy, with the investigational drug CRLX101~     in combination with bevacizumab compared to treatment with a standard of care therapy. The~     study will compare which treatment resulted in longer time before progression of the RCC.~     Patients will be treated and followed for progression of their disease on average for up to 6~     months.~   "
105436|NCT02187289|"~     Lymphedema (significant arm swelling on the surgical side) is one of the most common~     complications following treatment for breast cancer. The impact of lymphedema is profound,~     resulting in negative self image, increased anxiety and poorer quality of life. In time,~     lymphedema can result in recurrent infections in the arm, functional impairment and pain.~     Approximately 21% of women who undergo breast cancer treatment develop lymphedema.~     Unfortunately this is a life-time condition which tends to worsen over time. Currently,~     treatment consists of intensive physiotherapy, meant to reduce the arm volume followed by the~     wearing of compression sleeves during the day for maintenance. This study hopes to show that~     the addition of night-time compression creates a measurable reduction in arm volume and that~     adding night-time compression to the standard care (daytime compression only) will produce~     improvements in quality of life for breast cancer survivors.~   "
105488|NCT02186613|"~     The investigators will conduct a telephone-based support to breastfeeding women with healthy~     newborns to improve breastfeeding outcomes.~   "
105489|NCT02186600|"~     The purpose of this study is to identify the best way to prevent bone loss in the first years~     after menopause. The HOPS study will compare bone loss at 12 months in women: 1) who take~     calcium and vitamin D only; 2) who take calcium and vitamin D plus the medication~     risedronate; or 3) who take calcium and vitamin D plus participate in bone-loading~     exercises. Our central hypothesis is that improvements in bone health will be greater in~     women randomized to bone-loading exercises with calcium and vitamin D compared to women who~     take calcium and vitamin D only or women who take calcium and vitamin D plus risedronate.~   "
105437|NCT02187276|"~     Background and objectives: The aims of this naturalistic study were: to analyze factors which~     could be predictive of good response to cholinesterase inhibitors (ChEI), such as: age, sex,~     schooling, mild (CDR 1) or moderate Alzheimer's disease (AD),(CDR 2), Apoliprotein epsilon 4~     (APOE Ɛ4), among others, in their cognitive and clinical response. We also classified~     patients according to their response to Mini mental State of Examination (MMSE). Finally we~     saw the polymorphisms of APO E and cytochrome P450 2D6 (CYP2D6) and tried to correlate the~     response with different allelic forms of Apo E and among others with wild type homozygotes~     (wt/wt) and their polymorphisms (CYP2D6*3,*4, *5, *6 and 10) of CYP 2D6.~      Patients and Methods: 129 patients were diagnosed as AD or AD+cerebrovascular disease (CVD)~     mild or moderate. After 12 month-treatment, 97 patients completed the study. They were~     assessed (four) times. In the first visit, without taking ChEI, after 3, 6 and 12~     month-treatment, they were taking donepezil or rivastigmine or galantamine. We also extracted~     5 mL of blood sample to genotype the DNA. In each visit, we applied cognitive, functional,~     mood and behavior scales. Good responders were defined as those who scored > 2 in MMSE.~      Results and Conclusion: In longitudinal analysis, patients with mild AD and good responders~     at 3 months were considered good responders at 12 months. We obtained a higher rate of good~     responders comparing with other researches (27.8%). There was no correlation between dose,~     APOE and CYP 2D6 polymorphisms, although we already obtained clinical results with the dose~     dosage of 5mg.~   "
105438|NCT02187263|"~     This is a joint project by Heidelberg University and Greifswald University.~      Our objective is to establish an unique national multi-center registry and biobank of well~     phenotyped patients with non-ischemic cardiomyopathies (CMP) including in depth clinical,~     molecular and omics-based phenotyping to serve as:~        1. central hub for clinical outcome studies.~        2. joint resource for diagnostic and therapeutic trials.~        3. common biomaterial bank.~        4. resource for detailed molecular analyses on patients' biomaterials and patient specific~          model systems.~   "
105439|NCT02187250|"~     The purpose of this study was to determine whether monotherapy treatment with~     phosphodiesterase-4 (PDE-4) inhibitor roflumilast is more effective than treatment with~     glucagon-like protein 1 (GLP-1) liraglutide or treatment with metformin as monotherapy in the~     treatment of obese women with polycystic ovary syndrome (PCOS) regarding weight reduction who~     have not been treated before. The investigators anticipated greater changes in body weight in~     patients on roflumilast treatment than in liraglutide or metformin.~   "
105440|NCT02187237|"~     The YOLO TOUCH consists of a console and multi-probes that are placed on the treatment area~     that emit laser light to reduce the circumference waistline.~   "
105441|NCT02187224|"~     This is a randomized control trial with 36 participants diagnosed with post-traumatic stress~     disorder (PTSD) and comorbid alcohol dependence. Participants will be randomized to receive~     either progesterone (200 mg. bid) or placebo in identical looking capsules for three days.~      One goal of this research study is to test if progesterone is more effective than placebo in~     reducing craving after exposure to trauma cues and alcohol cues in a laboratory paradigm~     among men and women with AD and PTSD. We hypothesize that progesterone in comparison to~     placebo will significantly reduce craving for alcohol in response to trauma cues alone and in~     combination with alcohol cues in individuals with AD and PTSD.~      A second goal is to examine if there are gender differences in progesterone effects on stress~     and alcohol cue-induced craving. We hypothesize that the effects of progesterone on stress~     and craving will be stronger in women than in men. Participants will be recruited primarily~     through advertisement, but also through the clinical facilities at the VA and from other~     collaborators.~   "
105442|NCT02187211|"~     This is a double-blind, placebo-controlled, outpatient study with a between-groups design.~     Sixty male and female heavy social drinkers will be randomly assigned to minocycline (200 or~     400 mg/day) or placebo for 10 days. In the first 7 days of treatment, subjects will have 3~     outpatient visits for medication administration, dispensing of take-home doses and monitoring~     of any adverse effects from study medications. On days 8 and 10 of treatment, subjects will~     have 2 laboratory sessions where alcohol or placebo will be administered intravenously using~     a clamp procedure. Alcohol administration will use a breath alcohol concentration (BrAc)~     method, targeting 100 mg %. The alcohol clamp procedure will allow collection of multiple~     outcome measures including subjective, motor, cognitive measurement and plasma cytokine~     levels.~   "
105443|NCT02187198|"~     This is a randomized, open-label clinical trial with 200 Veteran opioid dependent men and~     women. Veterans will be randomized to one of two treatment groups: low dose range of~     buprenorphine (<8mg) vs. high dose range of buprenorphine (<16mg). During induction into~     buprenorphine, all participants will be started at a dose of 2mg, and this dose will be~     increased as needed for stabilization of opioid withdrawal symptoms, up to 8mg for the low~     dose group, and up to 16mg for the high dose group, within a 5 day period. Participants will~     be seen on a daily basis (excluding weekends) for the initial 5 day induction. At the end of~     the 12-week study, participants will either be referred to a buprenorphine clinic if they~     wish to continue this medication, or if they wish to be drug free, will undergo~     detoxification from buprenorphine for up to a 4-week period. Follow-up visits, scheduled at~     1, 3, and 6 months after study completion, will evaluate the durability of treatment effects~     on drug use and psychosocial outcomes. Veterans will be recruited primarily through~     advertisement, but also through the clinical facilities at the VA and from other~     collaborators.~   "
105444|NCT02187185|"~     This research study has 2 aims. One aim is to see if saliva testing can show if a person has~     healthy gum tissue, gingivitis, or one of three degrees of periodontitis - mild, moderate, or~     severe. The second aim is to examine the effect of the Sonicare Elite/Flexcare toothbrush on~     periodontitis.~   "
105445|NCT02187172|"~     The VIP-U Study is a clinical trial designed to investigate the effect of ustekinumab~     (Stelara) and placebo on reducing vascular inflammation and cardiometabolic risk biomarkers~     in patients with moderate to severe psoriasis.~      This study will look for systemic vascular inflammation in study participants with a test~     called FDG PET/CT (fluorodeoxyglucose-positron emission tomography/computed tomography). The~     study will also look for cardiometabolic identifiers (heart disease and metabolic factors) in~     blood samples, including markers of high cholesterol, cholesterol efflux function (the~     ability of cholesterol to move in the body), metabolic factors, and inflammation.~      The study will also examine the effects of ustekinumab compared to placebo on psoriasis~     activity, severity and safety.~   "
105449|NCT02187120|"~     The purpose of this research is to determine whether giving severely injured adults a drug~     called tranexamic acid (TXA) as soon as possible after injury will improve their chances of~     survival and their level of recovery at six months.~      After severe injury, a person may have uncontrolled bleeding that places them at high risk of~     bleeding to death. Coagulation (the formation of blood clots) is an important process in the~     body that helps to control blood loss. Up to a quarter of people that are severely injured~     have a condition called acute traumatic coagulopathy. This condition affects coagulation and~     results in the break down of blood clots (fibrinolysis) that can lead to increased blood loss~     and an increased risk of dying.~      TXA is an anti-fibrinolytic drug that might help to reduce the effects of acute traumatic~     coagulopathy by preventing blood clots from breaking down and helping to control bleeding. In~     Australia, TXA is approved for use by the Therapeutic Goods Administration (TGA) to reduce~     blood loss or the need for blood transfusion in patients undergoing surgery (i.e. cardiac~     surgery, knee or hip arthroplasty). Recent evidence from a large clinical trial (CRASH-2)~     showed early treatment with TXA reduced the risk of death in severely injured patients,~     however the majority of patients involved in the study were injured in countries where~     prehospital care is limited and rapid access to lifesaving treatments is limited compared to~     that available in countries like Australia and New Zealand. It is unclear whether TXA will~     reduce the risk of death to the same degree when it is given alongside other lifesaving~     treatments that are available to patients soon after injury in these countries.~      The hypothesis is that TXA given early to injured patients who are at risk of acute traumatic~     coagulopathy and who are treated in countries with systems providing advanced trauma care~     reduces mortality and improves recovery at 6-months after injury.~   "
105450|NCT02187107|"~     The purpose of this study was primarily to assess the long-term safety and tolerability of~     TMC114/rtv in addition to an individually optimized background antiretroviral therapy in~     HIV-1 infected participants. In addition, antiviral activity and immunological effect were~     also evaluated.~   "
105451|NCT02187094|"~     Gastroparesis, also referred to as delayed gastric emptying, is a debilitating, chronic~     disorder that slows or stops the passage of food from the stomach to the small intestine. The~     purpose of this study is to test whether TC-6499 is safe and effective at reducing gastric~     emptying time in diabetic subjects with gastroparesis.~   "
105452|NCT02187081|"~     Radiofrequency ablation (RFA)can be curative with small localized HCCs up to 5 cm in~     diameter. However, the long-term prognosis is not satisfactory due to the high incidence of~     recurrence.Multimodality treatments are needed to prevent recurrences，but only useful with~     locoregional disease. Sorafenib is an oral multi-kinase inhibitor and the only systemic drug~     associated with improved overall survival (OS) in patients with advanced HCC. Retrospective~     and randomized studies have suggested that the combined use of Sorafenib may be useful in~     patients with unresectable HCC. Based on these information and the multiple actions of~     Sorafenib, we hypothesized that Sorafenib plus RFA may be useful in patients with early to~     Mid term HCC. In this investigation, we evaluated the safety and efficacy of a combination~     Sorafenib and RFA therapy in patients with Barcelona Clinic Liver Cancer (BCLC) Stage 0 -B1~     HCC in a multicenter prospective cohort study.~   "
105453|NCT02187068|"~     The aim of this study is to characterize, using two different modeling approaches, one based~     on purely statistic concept and one using a more mechanistic analysis, the influence of body~     weight and composition on the pharmacokinetic of dexmedetomidine.~   "
105454|NCT02187055|"~     To assess the efficacy of tofacitinib monotherapy or tofacitinib with methotrexate as~     compared to adalimumab with methotrexate. To compare the efficacy of tofacitinib monotherapy~     compared to tofacitinib combined with methotrexate. To compare effects on all health outcomes~     measures in the study. To evaluate the safety and tolerability of tofacitinib and adalimumab.~     To evaluate the safety of the zoster vaccine given prior to the initiation of tofacitinb or~     adalimumab.~   "
105455|NCT02187042|"~     220 patients with metastatic and/or advanced renal cell carcinoma treated with sunitinib~     (Sutent) will be randomized into two arms :~        -  Control arm: Followed with standard care~        -  Experimental arm: Followed with standard care plus a call center~      Principal assumption : reduce the percentage of adverse events of grade 3, 4 by 20% between~     the control arm (60%) and the experimental arm.~   "
105456|NCT02187029|"~     The purpose of the study is to assess the effect of PF-06743649 in lowering serum uric acid~     in subjects suffering from gout following 14 days of dosing, as well as assessing safety and~     tolerability.~   "
105457|NCT02187016|"~     The purpose of this study is to evaluate the safety and efficacy of tooth and interproximal~     cleaning modalities with and without chemistry on oral health over 28 days.~   "
105458|NCT02187003|"~     This is a clinical study evaluating the efficacy and safety of rivipansel (GMI-1070) in~     treating subjects with sickle cell disease (SCD) who are 6 years of age or older experiencing~     a pain crisis necessitating hospitalization.~   "
105459|NCT02186990|"~     The purpose of this study is to evaluate the effect of propofol, etomidate and~     propofol-etomidate combination on hemodynamic responses during laryngoscopy and tracheal~     intubation and assess the adverse effect related to this drugs.~   "
105460|NCT02186977|"~     A proof of concept (POC) study will be conducted in 44 volunteers that have been fully~     vaccinated against hepatitis B in the past (at least 5 years ago) to assess the safety and~     immunogenicity of intradermal vaccination with hepatitis B surface vaccine antigen using a~     newly developed intradermal injection device VAX-ID, compared to intramuscular and~     intradermal (Mantoux technique) injection.~   "
105461|NCT02186964|"~     Pilonidal sinus is a chronic inflammatory disorder of intergluteal sulcus. The disease seen~     in between 15-35 years of age and 3-4 times more in males. The incidence of the disease is~     found as 8.8% in Turkish soldiers. The disorder mainly affects the quality of life.~      There are numerous methods in surgical treatment of Pilonidal sinus. The main difference in~     between those methods is the closing of the defect that occurs after the excision of the~     sinus tract. The defect can be closed by primary sutures or it can be left for secondary~     healing. Nowadays, the recurrence rate of flap procedures are lower therefore, flap~     procedures are commonly used. However, it has been reported that there is no difference~     between flap procedures and tension free primary closure. This result triggered the~     controversy that; if the healing side is tension free, midline suturing may have no~     importance. The aim of this study is to compare the results of 3 different surgical~     procedures used in treatment of pilonidal disease.~   "
105490|NCT02186587|"~     To compare the outcomes of patients receiving the ConforMIS custom total knee implant to the~     outcomes of patients who receiving an off-the-shelf total knee implant.~      Hypothesis: Patient-specific, custom total knee implants manufactured from patient CT data,~     and implanted with CT-navigated custom instruments will show faster functional recovery,~     including gait and patient functional outcome scores, when compared to standard,~     off-the-shelf total knee components inserted with non-navigated instruments (the present~     standard of care in total knee surgery).~   "
105462|NCT02186951|"~     Mild therapeutic hypothermia is currently recommended in management of cardiac arrests with~     shockable rhythm. In mechanically ventilated patients who were resuscitated after~     out-of-hospital cardiac arrests, mild therapeutic hypothermia side effects are conductive for~     infectious complications and especially for ventilator-associated pneumonia (VAP).~      Despite high incidence of VAP and other infectious complications, it is not currently~     recommended to use antibiotic prophylaxis on the responsible germs. Yet VAP incidence could~     be decreased if an antibiotic therapy was systematically given to patient treated with mild~     therapeutic hypothermia after a cardiac arrest. Several retrospective studies showed less~     infectious complications but also decreased morbidity and mortality related to these~     complications when antibiotic therapy was given early to patients treated with therapeutic~     hypothermia after cardiac arrest.~   "
105463|NCT02186938|"~     This study aims to investigate whether the intraoperative use of the FloTrac device to guide~     fluid and vasopressor management during head and neck free flap surgery improves~     postoperative outcome. Primary postoperative outcome is length of hospital stay. Secondary~     postoperative outcomes include days in ICU, days on ventilator, presence of postoperative~     pulmonary edema, need for postoperative vasopressors or transfusions, 30 day flap~     complication rate, inpatient postoperative cardiorespiratory complications/events, and~     overall 30 day flap failure rate.~   "
105464|NCT02186925|"~     Identifying clinical factors such as medication, background diseases and blood tests that~     effect the course of disease in cancer patients can help physicians to better decide on the~     patient's treatment plan. The study seeks to identify and analyze relevant clinical factors~     that effect the course of the disease and the results of treatment in patients with cancers~     of the prostate, bladder and kidney.~   "
105465|NCT02186912|"~     Indication : edentulous patients To evaluate and compare the marginal bone level change~     around tilted and straight NobelActive implants placed in healed sites with~     All-on-4-treatment concept after immediate function supporting NobelProcera Implant Bridge~     (fixed) in the mandible and maxilla.~   "
105466|NCT02186899|"~     Arthroscopic ACL repair can be performed under different types of anesthesia. In the last few~     years peripheral nerve blocks have increased their popularity for this kind of operation. The~     investigators want to see how the type of anesthesia and postoperative analgesia effects the~     time required for patient mobilisation.~   "
105467|NCT02186886|"~     Aim of this study is to determine wether the macromolecular spectral characteristic of~     ulcerative colitis patients - measured by Physiological Intermolecular Modification~     Spectroscopy (PIMS) - is a predictive factor for response to Simponi treatment~   "
105468|NCT02186873|"~     The purpose of this study is to evaluate the efficacy of intravenously (administration of a~     fluid into the vein) administered golimumab 2 milligram per kilogram (mg/kg) in participants~     with active ankylosing spondylitis (chronic inflammatory disease of unknown etiology that~     involves the sacroiliac joints, and often the axial skeleton, entheses, and peripheral~     joints).~   "
105469|NCT02186860|"~     Traditional standard treatments of B cell acute lymphoblastic leukemia is not perfect for~     fighting cancer. Many people do not respond to the standard treatments of ALL. One possible~     treatment is chimeric antigen receptor (CAR) modified T cell infusions. Third generation~     CAR-T which contains Cluster of Differentiation 28 (CD28) and Cluster of Differentiation 137~     (CD137) has stronger effect of anti-tumor capacity compare with second generation CAR-T. The~     investigators believe that the cells with CD28 and CD137 will have a better chance of killing~     the lymphoma cells. In the lab, the investigators constructed a third generation CAR~     containing both CD28 and CD137. The investigators start Phase I study aimed to chemotherapy~     resistant or refractory acute lymphoblastic leukemia patients. The purpose of this study is~     to assess the safety and effectiveness of third generation CAR-T cells in patients.~   "
105470|NCT02186847|"~     This randomized phase II trial studies how well chemotherapy and radiation therapy given with~     or without metformin hydrochloride works in treating patients with stage III non-small cell~     lung cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy~     x-rays to kill tumor cells and shrink tumors. Metformin hydrochloride may shrink tumors and~     keep them from coming back. It is not yet known whether chemotherapy and radiation therapy is~     more effective when given with or without metformin hydrochloride in treating stage III~     non-small cell lung cancer.~   "
105471|NCT02186834|"~     The main purpose of this study is to see whether the combination of Selinexor (KPT-330),~     liposomal doxorubicin and dexamethasone can help people with relapsed and refractory Multiple~     Myeloma. Researchers also want to find out the combination of Selinexor (KPT-330), liposomal~     doxorubicin and dexamethasone is safe and tolerable.~   "
105472|NCT02186821|"~     The purpose of this signal seeking study is to determine whether treatment with ceritinib~     demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic~     malignancies to warrant further study.~   "
105473|NCT02186808|"~     The objective of the study is to evaluate the clinical performance of Procera® Bridge~     Zirconia veneered with NobelRondo Zirconia.~   "
105474|NCT02186795|"~     The goal of this retrospective chart review is to evaluate if the implementation of lumbar~     plexus block placement for postoperative pain and administration of multimodal oral analgesia~     have improved conditions in the postoperative period for patients undergoing total hip~     arthroplasty when compared to the placement of epidurals for postoperative pain management.~   "
105475|NCT02186782|"~     The purpose of this study is to evaluate the effect of concomitant administration of~     estradiol during use of clomiphene citrate (CC) for induction of ovulation in infertile~     women.~   "
105476|NCT02186769|"~     A review of the amount of drug in your blood over time.~   "
105477|NCT02186756|"~     The purpose of this study is to determine whether EMG-Biofeedback is effective in the~     treatment of Fibromyalgia.~   "
105478|NCT02186743|"~     The primary objective of the clinical trial portion of this study is to assess whether an~     individualized dietary plan based on a commercial food sensitivity assay provides specific~     benefit in a randomized controlled trial in adults with irritable bowel syndrome (IBS).~   "
130829|NCT01854905|"~     This is an observational, study of dry eye in patients at the consultation visit prior to~     LASIK surgery. There is no treatment administered or intervention during the study.~   "
105479|NCT02186730|"~     This study forms the second phase of previous work to examine the effectiveness of~     computerised Cognitive Behaviour Therapy (cCBT) to treat adolescents with low~     mood/depression.~      Depression affects around 2% of adolescents. Antidepressants are not recommended for this age~     range as a first line treatment because of concerns about their usefulness and side effects.~     Government guidelines have supported using Cognitive Behaviour Therapy (CBT), which is~     effective and one of the main treatments recommended for depression. It has been suggested~     that computerised versions of CBT (cCBT) may be effective for treating depression in young~     people who may prefer this to seeing a therapist face-to-face, but little research exists to~     date to support this. This study examines the feasibility of running a large scale randomised~     controlled trial (RCT) to compare a promising cCBT program (Stressbusters) with self-help~     websites for adolescents with low mood and depression (LMD).~      Eligible and consenting participants will complete several questionnaires to assess their~     mood before being randomly assigned to either cCBT (Stressbusters) or equivalent access to~     selected websites providing self help for LMD. Participants will complete further mood~     questionnaires 4 and 12 months after treatment completion/withdrawal. We have already~     recruited 97 individuals to this trial but aim to recruit a further 48 participants to~     collect further information.~      We are also keen to find out whether sending participants text messages before sessions and~     around follow up periods will increase attendance/completion. Therefore all trial~     participants will receive text messages from the research team during their participation.~   "
105480|NCT02186717|"~     The specific aim of this prospective, randomized controlled trial is to compare the effect of~     chewing gum on the return of bowel function in a group of patients undergoing spinal surgery~     with a group of matched controls that do not receive any chewing gum. A 24-hour reduction in~     time to passage of first flatus will be considered an important clinical difference.~      The research questions are:~        1. Does providing chewing gum post-operatively hasten the return of bowel function?~        2. Does providing chewing gum post-operatively reduced overall length of stay?~        3. Does providing chewing gum post-operatively have any associated complications?~        4. Does providing chewing gum post-operatively result in higher objective outcomes scores?~      The secondary aims are:~        1. To compare hospital length of stay between the groups with a mean of ½ day considered~          clinically important.~        2. To compare time until tolerating regular diet as defined as two consecutive meals with~          no complications with 24 hours considered statistically significant.~        3. To compare incidence and nature of complications between the two groups.~        4. To compare the time until completion of rehab milestones with 1 day being considered~          clinically important.~        5. To compare the requirement for nutrition evaluations~        6. To compare SF-12 scores as a marker of patient satisfaction with a difference of 10~          points or more measured between the two groups upon discharge from hospital and at~          six-weeks after surgery.~   "
105481|NCT02186704|"~     The primary aim of the Sensing Atrial High Rate Episodes with DX System in Implantable~     Cardioverter Defibrillators Trial (SENSE Trial) is to assess the efficacy of a implantable~     cardioverter-defibrillator (ICD) lead with dedicated atrial sensing dipoles in detecting~     atrial high rate episodes.~      The study hypothesis is that an ICD system with a lead with dedicated atrial sensing dipoles~     will have a diagnostic yield comparable to that of a standard dual chamber ICD system and~     superior to that of a standard single chamber ICD system.~   "
105482|NCT02186691|"~     Long term survival of patients with repaired tetralogy of Fallot is excellent (about 85% at~     35 year-old). However these patients are exposed to residual pulmonary stenosis (PS) and/or~     pulmonary regurgitation (PR). It is well established that these lesions can lead to~     irreversible sequelae such as right ventricle dilatation and dysfunction. Pulmonary valve~     replacement technique was developed to avoid long term right ventricular dysfunction.~     Pulmonary valve replacement indications are based upon the presence of symptoms at exercise~     and/or morphological or functional parameters such as severe pulmonary regurgitation with~     right ventricle dilatation/dysfunction. The best timing of such intervention is still~     underdebate with the main aim of having the right balance between avoiding long term sequelae~     of PR or PS and being the latter possible to push ahead the need for new intervention. Recent~     publication showed that myocardial diffuse fibrosis can contribute to irreversible alteration~     of myocardial contractility. Quantification of diffuse fibrosis by magnetic resonance imaging~     is feasible and could help the physician to best determine the right timing for PVR in this~     population of patients. Cardiac function assessment at rest and during exercise is possible~     using MR and our centre has developed a program for cardiac exercise during MRI. This could~     help to detect infra clinic abnormality and to analyse myocardial adaptation during exercise.~   "
105483|NCT02186678|"~     18F-FDOPA PET-CT is currently the gold standard in the evaluation of Pheochromocytomas and~     Paragangliomas (PHEO - PGL) since these tumors can also decarboxylate amino acids such as~     dihydroxyphenylalanine (DOPA). This property is common to tumors of the APUD system (Amine~     Precursor Uptake and Decarboxylation). In recent years, PET (Positron Emission Tomography)~     imaging using peptide receptors has gained an increasing role in the management of NETs. The~     use of somatostatin agonists, radiolabeled with gallium-68 (68Ga) enables targeting of~     Somatostatin receptors (SSTRs) with a PET resolution. This has improved diagnosis of~     SSTRs-expressing tumors, including PGLs.~      In the present study, the investigators have chosen DOTATATE (Nal3-octreotate) rather than~     other agonists (DOTATOC and DOTANOC), because of its higher affinity for SST2 which is the~     most overexpressed subtype in PHEO/PGL. However, performances of 18F-FDOPA PET-CT and~     68Ga-DOTATATE PET-CT have never been compared in this clinical setting.~   "
105484|NCT02186665|"~     The purpose of this study is to compare the safety, efficacy and calcium metabolism of up to~     8 weeks of treatment with calcitriol 3 mcg/g ointment versus its vehicle, when used twice~     daily, without occlusion, to treat children aged 2 to 12 years, with plaque psoriasis.~   "
105485|NCT02186652|"~     Multicenter, comparative single-dose pharmacokinetic (PK) study~   "
105486|NCT02186639|"~     To answer the question whether a disease specific profile of breath in patients with COPD can~     be detected by an untargeted metabolomic study using exhaled breath analysis by mass~     spectrometry.~   "
105487|NCT02186626|"~     West Nile virus (WNV) is considered an emerging virus in the United States, and infection can~     lead to severe illness in older adults. This study will evaluate the safety of and immune~     response to a live West Nile virus vaccine (WN/DEN4Δ30) for the prevention of West Nile~     encephalitis in adults 50 to 65 years old.~   "
105493|NCT02186548|"~     Permanent canines in the maxilla usually erupt into the mouth at 11-12 years of age. In~     approximately 2% of the Swedish population they fail to erupt, and are then referred to as~     impacted. One severe complication of impacted maxillary canines is damage (root resorption)~     to the roots of adjacent teeth. The root resorption may be so severe that neighboring teeth~     are lost. If the impaction is detected early (at 9-10 years of age), the recommended~     treatment is to extract the deciduous canine, to help the permanent canine to resolve its~     unfavorable position. If there is no improvement of the position of the canine 1 year after~     the extraction, surgical and orthodontic treatment is indicated. Surgical exposure is~     followed by orthodontic treatment with fixed appliance for 2 to 3 years to bring the canine~     into correct position.~      Two different main principles of surgical exposure in palatally impacted maxillary permanent~     canines are the so called closed versus open surgical techniques.~      Closed technique involves surgically uncovering of the canine with a mucoperiosteal flap~     dissected off the bone. The bone covering the canine is being removed and an attachment with~     a chain is bonded to the tooth. The flap is repositioned and sutured back with the chain~     above the mucosa. Shortly after the surgery, orthodontic force is applied via the chain. The~     canine is orthodontically moved beneath the palatal mucosa by forced eruption.~      Open technique involves surgically uncovering of the canine, removing a window of tissue~     around it and placing pack to cover the exposed area. Then the treatment approaches vary~     depending on whether the attachment with a chain is bonded to the exposed tooth at surgery or~     if spontaneous eruption of the palatally impacted canine is expected postsurgically. In both~     alternatives orthodontic force is applied via the chain and the canine is orthodontically~     moved above the mucosa. These two techniques of surgical exposure of palatally impacted~     canines seem to be the two routinely used in Sweden.~      The purposes of this study are to examine, describe and compare the treatment outcomes in~     regard to success and duration of treatment, complications, side effects, cost-benefit~     aspects and patients´ perceptions in closed versus open surgical exposure techniques, in~     cases with palatally impacted canines.~      The objective is to test the null hypothesis that there are no differences in the above~     outcomes between open or closed surgical exposure of palatally impacted canines.~   "
105494|NCT02186535|"~     The purpose of this study is to assess the impact of approximately 8 weeks of Vitamin D~     (VitD) and calcium supplementation, using daily versus weekly supplementation regimens, on~     female reproductive tract immunity.~   "
105495|NCT02186522|"~     Patients admitted to intensive care units (ICU) are at high risk of developing secondary~     infections, and this is in part due to dysfunction or failure of their 'germ killing'~     functions (the immune system). Our group has recently identified three signatures of immune~     system failure which can be readily detected on a blood sample, and importantly, appear to~     predict the chances of developing secondary infection. Such a test would have major benefits~     for the management of patients in intensive care if it can be translated into a test usable~     in everyday clinical practice. This study aims to validate our original findings in a cohort~     of patients from multiple ICUs, using a test which will be suitable for everyday clinical~     practice, and thus take the next step towards developing a market-ready test.~      Study hypothesis:~      Measurement of neutrophil CD88, monocyte HLA-DR and percentage Tregs will accurately predict~     the risk of nosocomial infection.~   "
105496|NCT02186509|"~     This phase I trial studies the side effects and best dose of alisertib when combined with~     fractionated stereotactic radiosurgery in treating patients with high-grade gliomas that have~     returned after previous treatment with radiation therapy (recurrent). Alisertib may stop the~     growth of tumor cells by blocking an enzyme needed for the cells to divide. Radiation therapy~     uses high energy x rays to kill tumor cells. Stereotactic radiosurgery uses special~     positioning equipment to send a single high dose of radiation directly to the tumor and cause~     less damage to normal tissue. Delivering stereotactic radiosurgery over multiple doses~     (fractionation) may cause more damage to tumor tissue than normal tissue while maintaining~     the advantage of its accuracy.~   "
105497|NCT02186496|"~     The purpose of this study is to compare the safety and pharmacokinetics of CKD-330~     (fixed-dose combination of Candesartan 8 mg and Amlodipine 5 mg) with coadministration of the~     two separate drugs in healthy male volunteers.~   "
105498|NCT02186483|"~     The purpose of this study is to investigate the pharmacokinetic drug interaction between~     Metformin and Rosuvastatin in healthy male volunteers.~   "
105499|NCT02186470|"~     This pilot clinical trial studies intensity-modulated accelerated partial breast irradiation~     (APBI) before surgery in treating older patients with estrogen receptor positive or~     progesterone receptor positive stage I breast cancer. APBI is a specialized type of radiation~     therapy that delivers a high dose of radiation directly to the tumor may kill more tumor~     cells and cause less damage to normal tissue. Giving radiation therapy before surgery may~     make the tumor smaller and reduce the amount of normal tissue that needs to be removed.~   "
105500|NCT02186457|"~     The purpose of this study is to determine if the routine use of antibiotic irrigation during~     pancreas surgery (Whipple procedure) will decrease superficial and organ space infections.~   "
105501|NCT02186444|"~     The purpose of this study is to evaluate the impact of providing newly diagnosed prostate~     cancer patients and their caregivers with an interactive mobile tablet technology-based~     application delivered by a community navigator versus providing National Cancer Institute~     (NCI) information booklets delivered by a Community Navigator (CN) on patient outcomes~     (decisional satisfaction, quality of life, knowledge, decisional conflict) and shared~     decision making practices (decision making involvement).~   "
105502|NCT02186431|"~     To quantify and compare baseline tear proteins and ocular response in contact lens wearers~     with a history of corneal infiltrative events, to those without a history of complications.~     This will be accomplished via measurement of select anti-inflammatory tear proteins before,~     during and after contact lens wear.~   "
105503|NCT02186418|"~     The purpose of this study is to determine whether transfer of a fetal hemoglobin gene using a~     lentivirus vector (gene transfer) into human blood making cells is safe and feasible in~     patients with sickle cell disease.~   "
105504|NCT02186405|"~     Renal and cardiovascular effects of subclinical hypothyroidism, defined by a high TSH and~     normal T4 are less known and the indications for treatment of subclinical hypothyroidism are~     subject to controversies.~      The investigators propose to assess whether the hormone replacement for subclinical~     hypothyroidism in patients with chronic kidney disease is beneficial for hemodynamic and~     renal functions and which mechanisms are involved.~      Isotopic measurements of glomerular filtration and renal blood flow and an hemodynamic~     evaluation by transthoracic echocardiography and flow-mediated vasodilation will be carried~     out before and 6 months after substitution.~   "
105505|NCT02186392|"~     The purpose of this study is to investigate the impact of exposure to ergonomic circadian~     light on physiological and mental parameters in stroke patients admitted for rehabilitation.~   "
105506|NCT02186379|"~     The aims of this study are to develop a novel family-based behavioral intervention (Re-Pace)~     to help children at risk for obesity (children who eat rapidly and have an overweight~     parent/legal guardian) develop a more normal eating rate.~   "
105719|NCT02183610|"~     To determine the basic pharmacokinetics of BI 1356 BS, its metabolite CD 1750 XX and~     radioactivity including excretion mass balance, excretion pathways and metabolism following~     the intravenous and oral administration of [14C] BI 1356 BS~   "
105507|NCT02186366|"~     Generalized Anxiety Disorder (GAD) is characterized by the presence of persistent worry or~     fear of no explicit object and fixed content, or things that might occur in real life，which~     not corresponds with the realities. Patients with GAD may occur a series of somatic symptoms~     including muscle tension, backaches, headaches, fatigue, insomnia, restlessness, as well as~     psychological feelings of anxiety, worry and feeling overwhelmed. And it always brings some~     type of functional disability or decrease in quality of life. GAD is treated by Selective~     Serotonin Reuptake Inhibitors (SSRIs) or Serotonin, Norepinephrine Reuptake Inhibitors(SNRI)~     and 5-ht1a receptor agonists as regular medication which have the definite effects. But, some~     adverse reaction of SSRIs or SNRI leads to the compliance of taking medicine of patients with~     GAD. There is an impressive data suggesting that Abdominal Massage Therapy is effective in~     decreasing some symptoms of somatic symptoms and psychological feelings.~      This study is designed as a parallel group, positive control, non-inferiority study. It will~     recruit 140 cases of generalized anxiety disorder of deficiency of both heart and spleen~     type. Both the treatment group and the control group will be randomly assigned 70 cases.~     Patients in the treatment group will be treated by Abdominal Massage for 6 weeks，and the~     control group by buspirone . The total study includes 4 views that are respectively before~     the treatment，after 3 weeks treatment, after the whole treatment , and 3 months after the~     whole treatment. At all of the 4 views, all participants will be estimated the scores of~     Hamilton Depression Scale(HAMD) ,self-rating anxiety scale(SAS), and Quality of life~     assessment scale. At the second, third and the forth views, all participants will be~     estimated Clinical Global Impression ( CGI). At the first and the third views, all~     participants will be collected the data of content of hydroxytryptamine（5-HT）, Norepinephrine~     and total cortisol in blood plasma, and of blood stream speed, vascular resistance index and~     pulsatility index of middle cerebral artery （MCA）, anterior cerebral artery（ACA）, posterior~     cerebral artery （PCA） and basilar artery（BA）. This study aims to investigate the efficacy of~     Abdominal Massage Therapy vs. buspirone, and discover the correlation between these scales~     and these objective indicators.~   "
105508|NCT02186353|"~     The primary objective of this pilot study will be to examine the effects of consuming whole~     grains, differing in the degree of processing, on insulin sensitivity and other~     cardiometabolic risk factors. The overall aim will be to assess feasibility of the test diets~     and to generate preliminary data.~   "
105509|NCT02186340|"~     The improvement in inspiratory muscle function might result in beneficial changes in~     breathing pattern during whole body exercise. The hypothesis is the effect of inspiratory~     muscle training as an adjunct to a pulmonary rehabilitation program improves the breathing~     pattern during an incremental cycle exercise.~   "
105510|NCT02186327|"~     This study examines a pilot project to introduce integrative health coaching to two community~     clinical sites, Healing with CAARE Inc. and the Healthy Lifestyles program at Duke~     Pediatrics. 10 participants and 10 controls will be referred for enrollment at each site~     (n=20 per site) by on-site personnel, and 6 coaching sessions will be provided over a 3-month~     period at no cost by coaching trainees completing their certification hours. Pre and post~     measurements of BMI, patient activation, and perceived interpersonal support will be~     collected and analyzed for interaction effects. Qualitative process evaluation will be~     conducted as a thematic analysis via guided interviews with stakeholders and participants,~     using the RE-AIM framework. Feasibility measures will include recruitment of both coaches~     and clients, subject/client retention, and number and duration of coaching sessions~     completed. Finally, a subset of the CAARE Inc. cohort will be consented to participate in a~     post-intervention focus group that addresses the impact of coaching on perception of~     health-related resources and needs in the community.~      Primary Hypotheses:~      Integrative health coaching will be a feasible intervention in both community and clinical~     settings, in terms of required resources, patient or client adherence, and satisfaction by~     community stakeholders, including providers and participants.~      Additional hypotheses:~      Individuals who receive integrative health coaching sessions as an adjunct to their standard~     medical care will see improvements in patient activation and perception of interpersonal~     supports, when compared to controls.~      Individuals who receive integrative health coaching (or in the case of the pediatric cohort,~     children of individuals who receive coaching) will see minor improvements in BMI over the~     study period when compared to controls.~   "
105511|NCT02186314|"~     In this study we will select twenty patients with chronic atrial fibrillation and ventricular~     dysfunction with permanent cardiac pacemaker indication. We will dosage serum level~     natriuretic peptides for comparison between conventional and bifocal cardiac pacing.~   "
105512|NCT02186301|"~     The purpose of this study is to compare the safety and anti-tumor effect of rociletinib with~     erlotinib in patients whose tumors have specific EGFR mutations and who have not previously~     received any treatment for advanced/metastatic EGFR mutated NSCLC. This study is a~     'Randomized' Study. This means that upon entering the study, patients will be randomly~     assigned to be dosed with either rociletinib twice a day or erlotinib once a day. Patients~     will continue to take either rociletinib or erlotinib until it is no longer beneficial.~   "
105513|NCT02186288|"~     Effect of High-flow nasal cannula oxygen on end-expiratory lung volumes determined by~     electrical impedance tomography~   "
105514|NCT02186275|"~     The purpose of this study is to determine if vitamin D as an adjuvant therapy can improve the~     outcome (i.e. fewer relapses) and the quality of life, including levels of physical activity,~     in children with newly diagnosed Crohn's disease (CD).~   "
105515|NCT02186262|"~     Grading of gliomas is of significant clinical importance since the prognosis as well as the~     treatment of choice are distinct in low-grade and high-grade gliomas. With standard MRI~     modalities, however, a reliable distinction is often impossible. Moreover, the gold standard~     for glioma grading by histopathology may also have limitations due to unrepresentative tumor~     samples. Therefore, more advanced MRI techniques are urgently needed that would have higher~     sensitivity and specificity in the definition of tumor type, grade and extent.~      Assessment of radiologic response for high-grade gliomas utilizes the updated RANO criteria~     12 weeks after completion of chemoradiotherapy. However, there is an urgent need to identify~     nonresponding patients earlier, preferentially midtreatment in order to consider alternative~     treatment strategies. Imaging biomarkers, such as diffusion weighted MR imaging (DWI), have~     provided promising results in assessing early treatment response. Furthermore, a serum~     biomarker with diagnostic value could improve tumor follow-up and clinical management of~     gliomas.~      The aim of our study is to develop novel imaging protocols suitable for the magnetic~     resonance imaging (MRI) of glioma using advanced MRI techniques such as rotating frame~     imaging, novel DWI acquisition and post-processing methods We also study the correlation~     between advanced MRI parameters and histopathology of the tumor specimen. In addition, early~     treatment response is assessed with advanced MRI parameters at 3 week and 10 week after~     initiation of radiotherapy. Finally, our objective is to study the association between serum~     biomarkers and corresponding MRI with potential tumor progression.~   "
105516|NCT02186249|"~     The purpose of this study is to provide treatment with nivolumab in combination with~     ipilimumab to subjects who are anti-(CTLA)-4 and anti-PD-1 treatment-naive and have~     unresectable or metastatic melanoma.~   "
105720|NCT02183597|"~     Develop and optimize protocols for whole body MRI for detection of metastases. Evaluate~     diagnostic accuracy through application of optimized protocols for screening of cancer~     patients.~   "
105721|NCT02183584|"~     Investigation of the bioavailability of linagliptin after concomitant multiple oral~     administration of 5 mg linagliptin tablets and 600 mg rifampicin (Treatment A) in comparison~     to multiple oral administration of 5 mg linagliptin tablets given alone (Treatment B)~   "
105517|NCT02186236|"~     The purpose of this study is to see whether gene mutations can be found in the urine or blood~     of lung cancer patients and urine of colorectal cancer patients. Gene mutations are when DNA~     in a gene is damaged in a way that changes the genetic message carried by that gene. Gene~     mutations can sometimes cause lung cancers. These gene mutations are only found in lung and~     colorectal cancer cells, not the normal cells in your body. All lung cancer tumors and~     colorectal cancer tumors are now tested for different gene mutations as their presence~     affects lung cancer treatment. Tumor samples obtained from a biopsy or surgery are typically~     tested for these gene mutations.~   "
105518|NCT02186223|"~     The primary objective of this multicenter, prospective, single arm clinical trial is to~     evaluate the safety and effectiveness of the Angel® Catheter in subjects at high risk of PE,~     and with recognized contraindications to standard pharmacological therapy (anticoagulation).~   "
105519|NCT02186210|"~     Intraoperative hypothermia may affect tissue microcirculation and can induce myocardial~     injury, wound infection, and coagulopathy. During off-pump coronary artery bypass surgery~     without cardiopulmonary bypass or induced hypothermia, maintenance of normothermia is~     important for clinical outcome. The investigators hypothesized that prewarming during~     induction of general anesthesia would reduce drop of body temperature and change of~     peripheral microcirculation.~   "
105520|NCT02186197|"~     Shock and respiratory failure are common reasons for admission to the intensive care unit~     (ICU) at our institution. The various causes of acute shock and respiratory failure are~     traditionally assessed with the use of history, physical examination, chest x-ray, EKG and~     laboratory studies. Unfortunately, much of this clinical information is either insensitive or~     non-specific. 1 Critical care ultrasound (CCUS) is a rapid and non-invasive tool, which has~     been shown to be useful in the intensive care unit to assist in the diagnosis and management~     of patients in shock or respiratory failure.2~      The investigators hypothesize that the trained fellow's interpretation of critical care~     ultrasound images will be accurate when compared to experts and that ultrasounds will change~     diagnosis and management of the patient in shock and respiratory failure.~   "
105521|NCT02186184|"~     Orthokeratology is becoming popular for the treatment of myopia children. Many studies have~     shown that orthokeratology is effective in temporarily reducing refractive error, and is also~     helpful for controlling myopia progression. However, the mechanism for its slowing myopia~     progression and rebound effect after the treatment have not been clearly studied. In~     addition, the effect of orthokeratology among Chinese children has not been evaluated with~     randomized controlled trial.This study is to assess the effect of orthokeratology versus~     spectacles on myopia progression in school-aged Chinese children during two years.~   "
105522|NCT02186171|"~     This is a phase 3 multicenter study to compare the efficacy and safety of Romosozumab (AMG~     785) with placebo in men with osteoporosis.~   "
105523|NCT02186158|"~     Pneumonia is the second common infection and its risk increases for elderly. In this~     population, it is the first cause of mortality by infections, and source of many~     complications. Geriatric studies had shown the high prevalence of ascorbic acid 's~     deficiency, especially in older hospitalized people. It is well known that vitamin C is one~     of the key of the immune system, it has a scavenger's role in case of aggression like sepsis.~     A Cochrane database published in 2013 analyzed the impact of vitamin C for preventing and~     treating pneumonia. Two randomized studies showed a benefit on respiratory symptoms for~     patients treated by vitamin C, and for one of those studies it was noted a significant~     reduction of mortality. The main objective of our study is first to determine the impact on~     respiratory symptoms of an adjuvant treatment by vitamin C for the management of pneumonia in~     older people hospitalized, and then evaluate its impact on functional status.~   "
105524|NCT02186145|"~     The purpose of this study is to evaluate the efficacy and safety of association of~     metronidazole, nystatin and dexamethasone in the treatment of bacterial and fungal vaginal~     infections.~   "
105525|NCT02186132|"~     Balanced general anesthesia with neuromuscular blocking agents has been widely used for~     surgery.. At the end of surgery, neostigmine has been given for the reversal of neuromuscular~     blocking agents with several adverse effects such as bradycardia and profuse secretion.~     Atropine has been used to prevent those side effects of neostigmine. The routine dosages of~     the two drugs are 2.5 mg of neostigmine and 1.2 mg of atropine.~      Tribuddharat S ey al. (1) has demonstrated that after giving 0.9 mg atropine together with~     2.5 mg of neostigmine the mean heart rate during 1-8 minutes after the administration was~     increase 2-26 beats/min (bpm). At 9 and 10 minutes after administration of the drugs, the~     mean heart rate were decrease 0.9 and 1.6 bpm In the control group which receiving 1.2 mg of~     atropine, the mean heart rate during 1-10 minutes after administration was increase 4-32 bpm.~     However this study did not report the incidence of bradycardia and blood pressure. The mean~     heart rate prior to atropine and neostigmine was 74.43 + 11.82 bpm.(1)~      Salem MG et al. (2) has demonstrated that after receiving 1.2 mg of atropine and 5 mg of~     neostigmine the mean heart rate during 2-110 minutes was decrease 5-29 bpm with the lowest~     heart rate at 40 minutes after administration. This study also did not report the blood~     pressure.~      The baseline heart rate (HR) before administration of the reversal was associated with the~     following heart rate. Heinonen J et al. (3) has demonstrated that 80% of the patients after~     receiving 0.015 mg/kg of atropine 3 minutes before 0.03 mg of neostigmine for the reversal of~     pancuronium experienced bradycardia (heart rate < 50 bpm) compared with none in patients~     receiving alcuronium. However, before administration of atropine and neostigmine, the mean~     heart rate of patients was significantly lower in the pancuronium group.~      Either tachycardia or bradycardia with hypotension causes adverse affect to patient~     especially in specific group like patient with coronary artery disease or undergoing~     craniotomy.~      The primary objective of our study is to demonstrate the effect on heart rate (HR) and blood~     pressure of 0.6 mg atropine and 2.5 mg neostigmine for the reversal of muscle relaxant~     compare to 1.2 mg atropine.~   "
105526|NCT02186119|"~     This is a safety and efficacy study of abicipar pegol in patients with diabetic macular~     edema.~   "
105527|NCT02186106|"~     Severe vitamin D deficiency can be treated with oral loading doses of cholecalciferol. Our~     objective was to determine how to calculate the quantity of cholecalciferol needed for~     supplementation by single algorithm, usable on a patient-to-patient basis.~      We've conducted two studies. Study 1 was done retroactively and included 88 patients treated~     for low vitamin D, 60 of those with a loading dose. The second study included 29 patients and~     aimed to test the validity of an algorithm based on data from study 1, which included patient~     BMI. Both studies used oral loading doses and daily supplementation of cholecalciferol.~   "
105528|NCT02186093|"~     There are several physiologic parameters in evaluating cardiovascular disease. This study~     will reveal which parameter is the most proper value in predicting disease severity and risk~     factors of patients.~   "
105529|NCT02186080|"~     This is an exploratory study on the metabolic endotoxemia associated with type 2 diabetes.~     The investigators will measure systemic endotoxin level and lipid level after ingestion of~     high fat diet to evaluate the effect of gemigliptin, a DPP-4 inhibitor, on metabolic~     endotoxemia and lipemia induced by high fat diet.~   "
105722|NCT02183571|"~     Investigation of bioequivalence of BMS Glucophage® tablets and Merck Glucophage® tablets in~     the strengths of 1000 mg (part I) and 500 mg (part II)~   "
105530|NCT02186067|"~     Hypertension has become a public health concern worldwide due to its significant contribution~     to the global health burden and its role as a prominent risk factor for the development of a~     number of chronic diseases such as Cardiovascular diseases (CVD), the leading cause of~     mortality in Pakistan and Worldwide. According to WHO, about 7.5 million deaths worldwide is~     attributable to hypertension i.e. about 12.8% of the total of all deaths. This accounts for~     57 million disability adjusted life years (DALYS) or 3.7% of total DALYS.~      Studies suggest that hypertension is among the top five most common presenting complaints to~     private general practice clinics. Therefore, primary care physicians/Family physicians are~     the first line service providers and; thus it is important to manage hypertensive patients~     early, through lifestyle and treatment interventions that may prevent the complications such~     as development of CVDs etc.~   "
105531|NCT02186054|"~     The purpose of this study is to test two new MRI (magnetic resonance imaging) sequences to~     see how they compare to previously used imaging sequences as they may improve the quality of~     abdominal MRI.~   "
105532|NCT02186041|"~     The purpose of this study is to document the safety, the effectiveness, the continued~     performance at mid and long term, the morbidity and the percent of surgical revisions of the~     Interstim® therapy for up to 5 years in a representative sample of French centers under~     real-life conditions of use.~   "
105533|NCT02186028|"~     The purpose of the study is to evaluate the effect of daily oral supplementation with vitamin~     D on serum Vitamin D levels in term healthy newborns. It has been found in various studies~     that vitamin D is highly deficient in Indian mother infant diads. There is a need to~     supplement vitamin D from neonatal period to prevent various metabolic disturbances due to~     vitamin D deficiency in later life. This study aims to find the effectiveness and the optimum~     dose of routine vitamin D supplementation in healthy term newborns for fulfilling the normal~     requirements in Indian infants.~   "
105534|NCT02186015|"~     Background: Several clinical trials are underway to investigate if variable forms of vitamin~     D (D2 vs. D3) prescribed at different doses (10,000-50,000 IUs/week) can improve the~     side-effects associated with treatment for estrogen receptor positive (ER+) breast cancer,~     specifically aromatase inhibitors (AIs.) Presumably for generalizability and potential safety~     purposes, these trials predominantly exclude women with metastatic breast cancer (MBC); a~     rapidly expanding sector of the cancer survivor population who experience significant~     treatment-related side-effects. Evaluation of the safety of vitamin D3 supplementation is~     crucial since supplementation can lead to high calcium and importantly, in lab studies have~     shown that vitamin D3 affects a gene that increases estrogen production. To assure that~     vitamin D3 does not affect the clinical effects of anti-estrogen therapies, the effect of~     vitamin D3 supplements on estrogen production requires an evaluation that further explores~     and defines its potential role in symptom management for this population.~      Objectives: This pilot study will evaluate the feasibility of vitamin D3 supplementation in~     women with MBC, providing much needed data on the preliminary safety and efficacy of this~     treatment in this patient population. This study will determine: 1) if weekly supplementation~     of high dose vitamin D3 increases serum vitamin D levels without adverse effects related to~     such therapy (primary aim); 2) the effects of vitamin D3 supplementation on symptom~     management (secondary aim); and 3) if vitamin D3 supplementation is associated with improved~     inflammation (exploratory aim.)~      Methods: This is an 8 week proof of concept study to monitor important laboratory~     parameters and to assess potential effects on short-term outcomes. Adult, female patients~     (>=18 years) with ER+ MBC (Stage IV) of any race/ethnicity and a history of vitamin D < 30~     mg/dl will be recruited from within and around LUMC. Following current clinical practice~     guidelines, eligible participants will receive 50,000 IUs of vitamin D3 weekly for 8 weeks.~     Laboratory values, muscle function and inflammation will be examined pre- and~     post-supplementation, while symptoms (e.g., pain, sleep, fatigue, mood, and overall quality~     of life) will be assessed at baseline, 4 and 8 weeks post-supplementation. We will assess if~     increases in vitamin D are associated with clinically significant changes in serum estradiol,~     improvements in symptoms and QOL, and decreased inflammation, controlling for sunlight~     exposure, diet, physical activity and body composition.~   "
105535|NCT02186002|"~     The primary objective of the study was to evaluate the safety and tolerability of ACT-451840~     in healthy male subjects.Secondary objectives were : to investigate the pharmacokinetics (PK)~     of ACT-451840; to investigate the effect of food on the PK of ACT-451840; to evaluate the~     urinary excretion of ACT-451840 and to investigate the antimalarial activity of ACT-451840.~   "
105536|NCT02185989|"~     Early mobilization (from the first day if possible), first passive and then passive and~     active, is recommended for critically ill patients in whom it reduces the duration of~     mechanical ventilation, the length of hospital stay, improves functional status, muscle~     strength and quality of life after hospital discharge. The early addition of leg bicycling on~     a cyclo-ergometer is now part of common practice in the ICU. It can preserve or improve~     muscle strength and further increase the beneficial effects of early mobilization. Electrical~     muscle stimulation of the quadriceps, is practiced in some intensive care units, and it~     should, in theory, also through an improvement of muscle strength, increase the beneficial~     effects of early mobilization.~      We hypothesized that early quadriceps electrical stimulation and early work on a~     cyclo-ergometer associated with a standard protocol of early passive/active mobilization in~     the ICU may improve muscle function and reduce the duration of mechanical ventilation, length~     of stay, the number of readmissions and improve the quality of life in the mid term in~     critically ill patients, as compared to a conventional protocol of early passive/active~     mobilization.~   "
105537|NCT02185976|"~     Preoperative Anxiety is a major problem in anesthesia management. Paediatric patients are a~     special group who need special attention. Some studies have shown that cartoons are a very~     good tool for distraction in the preoperative period for children.~      Our hypothesis is that children watching Cartoons in the preoperative period will have less~     anxiety and will be fit with preparation.~   "
105538|NCT02185963|"~     The patients who have achieved LDL-C levels below the currently recommended targets may still~     experience cardiovascular events. To reduce further the risk of coronary heart disease (CHD),~     raising HDL-C and lowering TG may be the secondary therapeutic target. However, increased~     HDL-C levels do not mean increase in functional HDL-C. It also remains controversial whether~     functional HDL is more important than total circulating levels of HDL-C in reducing CHD.~      Actually, the increased concentration of HDL alone might be ineffective indicating that~     qualitative changes in HDL levels in response to drug interventions are required to result in~     clinical benefit.~      The investigators set up a clinical trial investigating effect of (rosuva)statin treatment on~     functional HDL-C levels particularly in Asian populations, who have relatively low HDL-C.~   "
105629|NCT02184780|"~     This study aims to determine the impact of perinatal exposure to anaesthesia and analgesia on~     neurocognitive outcomes in early childhood by analyzing neurocognitive data already obtained~     from the local prospective observational cohort study: Growing up in Singapore Towards~     Healthy Outcomes (GUSTO).~      We hypothesize that:~        1. Perinatal exposure to anaesthesia and analgesia is associated with poorer neurocognitive~          outcomes at 6, 18, 24 and 36 months.~        2. Maternal anxiety and depression during the antenatal and post-partum period is~          associated with poorer neurocognitive outcomes at 6, 18 24 and 36 months.~   "
105539|NCT02185950|"~     Burning produces changes in the biomechanical properties of the skin causing limitation of~     movement. The increase in skin suppleness is very important in the rehabilitation process,~     since its increase makes therapeutic interventions aimed at increasing the range of motion,~     thus improving functional pattern. Will be evaluated 60 volunteers of both sexes aged 20-80~     years seen at the Burns Unit of the Clinical Hospital of the Faculty of Medicine of Ribeirão~     Preto. There will be a traditional physical therapy evaluation as well as evaluation of the~     specific characteristics of the burn and scar. The temperature of the region will be assessed~     by thermography, and biophysical parameters and biomechanical skin evaluated by Cutometer and~     their accessory probes (mexameter, reviscometer, sebometer) before, immediately after and 10,~     20 and 30 minutes of application of therapeutic resources. Volunteers will undergo continuous~     application of ultrasound with 3 MHz and intensity of 1 W/cm2 in the region due to scar deep~     second degree burn or third degree, and the application time of 2 minutes for each effective~     radiation area of the head (ERA) in a predetermined region of 9X5 cm a total of 4 minutes of~     application, therapy paraffin 20 minutes and 4 minutes endermology negative pressure between~     100 and 200mmHg, in a continuous mode with glass head (1.5cm in diameter .) Applications will~     be set by random draw (design crusader cross-over) with an interval of 7 days between~     applications (wash-out). The data will be submitted to analysis of normality by the~     Shapiro-Wilk test, and the behavior of the effect between groups and pre-and~     post-intervention will be evaluated by two-way ANOVA followed by post-hoc (Bonferroni) or~     Friedman, p <0.05~   "
105540|NCT02185937|"~     The most common sites for GIST to occur are the stomach (60-70%) and proximal small~     intestines (20-25%). Therefore patients with GIST often have altered GI-tract due to tumor~     resection or palliative surgery which might affect imatinib exposure. Indeed, Yoo et al.~     showed that steady state imatinib trough levels in patients with advanced GISTs after major~     gastrectomy are lower compared to patients with a previous wedge resection or without gastric~     surgery. Patients that underwent major gastrectomy had an average imatinib plasma trough~     levels below 1000 µg/L. This while imatinib trough levels above 1000 µg/L are correlated to~     more beneficial treatment out-comes (longer Progression Free Survival).~      Since imatinib easily and rapidly dissolves at pH 5.5 or less, a lack of gastric acid~     secretion might be causing the decreased exposure in the patients that underwent major~     gastrectomy.~      Therefore the investigators would like to study if the exposure to imatinib in patients after~     major gastrectomy can be improved by creating a more acidic environment for absorption~     through combining imatinib intake with Coca-Cola.~   "
105541|NCT02185924|"~     Combination of continuous femoral block with parEcoxib vs placebo. Investigation of morphine~     consumption, opioid sparing effects, VAS pain scores, haemodynamics, Anxierty scores,~     transfusion requirements , Range of motion and rehabilitation parameters between two groups~   "
105542|NCT02185911|"~     To describe anaemia correction via haemoglobin measurements taken throughout observation~     period in ESA naive patients with chronic kidney disease initiated on darbepoetin alfa QM~   "
105543|NCT02185898|"~     This study will assess environmental emissions of selected compounds in a test chamber after~     cigarette smoking or e-cigarette vaping.~   "
105544|NCT02185885|"~     STUDY HYPOTHESIS~      In cardiac surgery the volume of perioperative cerebral infarctions can be reduced by~     increasing mean arterial pressure (MAP) during the cardiopulmonary bypass procedure.~      BRIEF STUDY SUMMARY~      Heart surgery using cardiopulmonary bypass (CPB) can be complicated by injury to the brain.~     Previous studies using brain scans have reported small stroke-like lesions in up to 51% of~     patients after cardiac surgery. However, only 1-6 % of patients have permanent symptoms of~     severe brain damage.~      The majority of brain lesions seem to be caused by particulate matter (emboli) that wedge in~     blood vessels of the brain thereby compromising flow. In addition, insufficient blood flow to~     areas of the brain supplied by narrowed, calcified vessels may contribute. MAP during CPB~     usually stabilizes below the lower limit of cerebral autoregulation, which is accepted since~     sufficient total blood flow is guaranteed during CPB.~      The aim of the PPCI trial is to investigate if increased MAP during CPB can prevent or reduce~     the extent of brain injury after cardiac surgery. A beneficial effect could result from~     reduced embolic injury through increased blood flow in collateral vessels and/or by increased~     blood flow in calcified arteries.~      180 patients scheduled for cardiac surgery will be randomly allocated to increased MAP (70-80~     mm Hg) or 'usual practice' (typically 45-50 mm Hg) during CPB, whereas CPB blood flow is~     intended equal and fixed in the two groups. Patients are examined before and 3-6 days after~     surgery with magnetic resonance imaging (MRI) brain scans, mental tests and by blood borne~     markers of brain injury.~      If higher MAP during CPB is beneficial, a change of practice can easily be implemented in the~     clinical routine.~   "
105545|NCT02185872|"~     The purpose of this study was to examine the differences in glucose control, fitness, and~     body composition between a standard aerobic and resistance exercise training program and a~     shorter-duration, high-intensity CrossFit training program in overweight and obese physically~     inactive adults.~      Hypotheses:~        1. Both groups would improve glucose control, with the CrossFit group improving~          significantly more than the aerobic and resistance training group.~        2. Both groups would improve fitness, with the CrossFit group improving significantly more~          than the aerobic and resistance training group.~        3. Both groups would demonstrate decreases in body fat percentage and fat mass and~          increases in lean body mass, with the CrossFit group improving significantly more than~          the aerobic and resistance training group.~   "
105567|NCT02185586|"~     We have designed a new method which could be used in laparoscopic cholecy- stectomy.Account~     to this new method, the three incisions are all located on the lower abdominal, theoretically~     it could get more beautiful outlook and less stress response than traditional laparoscopic~     cholecystectomy(two of the three incisions located on upper abdomen) or single port~     laparoscopic cholecystectomy(one large incision located on umbilicus).~      We plan to conduct a randomized controlled trial to compare those there methods of~     laparoscopic cholecystectomy, in order to find out if there will be some advantages of this~     new method,such as in lowering the stress response,reducing impact on respiration, relieving~     post-operation pain and improving appearance.~   "
105630|NCT02184767|"~     This study is to assess the pharmacokinetics of loxapine and will be using plasma~     concentration data obtained over 48 hours after administration of the study drug~   "
105546|NCT02185859|"~     Postsurgical pain is a relevant side effect following surgery which increases the risk of~     various complications and delays postoperative patient recovery. Among the many types of~     surgeries, mastectomy causes not only acute but also chronic pain in many patients.~     Therefore, it is important to control pain and increase patients' recovery satisfaction~     following many kinds of operations by using as small an opioid analgesic dose as possible and~     adding a nonopioid analgesic to reduce the side effects of narcotic analgesics. Among~     nonopioid analgesics, lidocaine and magnesium are drawing attention, having been shown to be~     helpful in controlling postoperative pain by lowering pain hypersensitivity to surgical~     stimuli. An intraoperative intravenous injection of lidocaine has been reported to improve~     postoperative pain control by reducing postoperative pain and opioid consumption. Another~     report showed that an intraoperative intravenous injection of lidocaine improved the quality~     of postoperative functional recovery after general anesthesia in a laparoscopic~     cholecystectomy patient. In addition, a review article on the effect of intraoperative~     intravenous injection of magnesium found it to be an effective analgesic that may be added to~     conventional opioid-based therapy because it generally reduces opioid consumption, decreases~     pain assessment for 24 hours after surgery, and lacks severe side effects in relation to~     magnesium administration. However, there has been insufficient research comparing the~     intraoperative intravenous injection of lidocaine or magnesium in terms of which is more~     helpful for general functional recovery and decreased postoperative pain. Recently, the scope~     of research on anesthesia has come to embrace postanesthetic recovery; to help patients~     return to daily life, the research trend is now shifting from the improvement or resolution~     of a specific symptom to the measurement of general recovery. A widely used method to measure~     postoperative recovery is the Quality of Recovery 40 (QoR-40) survey.~      Therefore, in this study, the researchers investigated the intraoperative intravenous~     injection of lidocaine and the intravenous injection of magnesium to compare these drugs'~     helpfulness in the functional recovery of mastectomy patients after general anesthesia.~   "
105547|NCT02185846|"~     To assess the bioequivalence of the investigational TEST product with the marketed REFERENCE~     products by measurement of Plasma concentrations of Erythromycylamine and calculation of the~     bioequivalence parameters from those measurements followed by ANOVA and 90% confidence~     interval statistical evaluation.~   "
105548|NCT02185833|"~     To assess the bioequivalence of the investigational TEST product with the marketed REFERENCE~     products by measurement of Plasma concentrations of Erythromycylamine and calculation of the~     bioequivalence parameters from those measurements followed by ANOVA and 90% confidence~     interval statistical evaluation.~   "
105549|NCT02185820|"~     This protocol is a phase I/II multicenter study designed to assess the safety and the~     efficacy of the proposed combinations in relapsed and/or refractory Multiple Myeloma (MM)~     patients.~   "
105550|NCT02185807|"~     The investigators will investigate whether video-assisted informed consent is superior to~     routine discussion for cataract patients about risks, benefits and alternatives to receiving~     phacoemulsification cataract extract and intraocular lens implantation, and will determine~     whether video-assisted informed consent can reduce the work load of physicians.~   "
105551|NCT02185794|"~     This study will evaluate the safety, tolerability, and antiviral activity of GS-9857 alone or~     with sofosbuvir (SOF)/GS-5816 fixed dose combination (FDC) in adults with genotypes 1, 2, 3,~     or 4 hepatitis C virus (HCV) infection. All participants will be monitored for up to 48 weeks~     after the last dose to monitor for persistence of viral mutations.~   "
105552|NCT02185781|"~     The present study aims at studying how safe and tolerable a new therapy for patients with~     Acute Lymphoblastic Leukemia (ALL) is.~      This new therapy consists of an immunotherapy, that is an approach focusing on the immune~     system, and it targets ALL patients in complete remission but who may still have the disease~     at a cellular level (this is called 'minimal residual disease').~      For any further information, please, discuss with your treating physician.~   "
105553|NCT02185768|"~     The most frequently used products in CHE are doxorubicin (36%), cisplatin (31%), and~     epirubicin (12%). But until recently, there were no obvious reasons to use one product over~     another. In fact, systemic chemotherapy is considered ineffective in HCC [hepatocellular~     carcinoma], which does not allow any argument in favour of the product. Moreover, 2~     randomised trials comparing the molecules (doxorubicin vs. epirubicin) proved to be negative~     in terms of survival.~      Cytotoxicity of different anticancer agents on HCC cell lines have been compared in order to~     select the best candidate for CHE. Eleven chemotherapy molecules have been tested, including~     those more frequently used in CHE. Among them, idarubicin (an anthracycline) proved to be the~     most effective in vitro by far. The superiority of idarubicin (as opposed to doxorubicin) was~     noted especially on the SNU-449 line, which is known for its resistance to several~     chemotherapy agents. The best cytotoxicity of idarubicin can be explained by 2 mechanisms: 1)~     idarubicin has a better intracellular penetration than the other anthracyclines. This is~     probably due to its more considerable lipophily, facilitating thus its passage through the~     membrane made up of a double lipid layer, 2) idarubicin is resistant to the multidrug~     resistance system (MDR). The MDR mechanism, which is often noted in HCC, consists of membrane~     pumps transporting the molecule outside the cell. These two particularities could explain a~     more significant accumulation of idarubicin in the HCC cells, and thus better efficacy. It is~     interesting to note that orally administered idarubicin (5 mg/day for 21 days) has proved to~     be less toxic and is effective in HCC. Currently, idarubicin is used to treat leukaemia. Its~     toxicity profile (especially, haematological and cardiac) is known.~      On these grounds, A pilot study has been conducted in order to assess the tolerance and~     efficacy of lipiodol-based CHE using a 10 mg dose of idarubicin in 21 patients with~     unresectable HCC. These preliminary data reveal that CHE with idarubicin is effective and~     less toxic.~      Idarubicin can be loaded in microbeads. A phase I study (IDASPHERE) has been conducted on DC~     Beads® microbeads (300-500µm) loaded with idarubicin (dose increased from 5 to 25 mg). The~     DLT [dose-limiting toxicity] and MTD [maximum tolerated dose] have been determined in 21~     patients using a CRM. The MTD of idarubicin was assessed at 10 mg. In our study, the~     idarubicin-loaded beads did not give rise to any specific toxicity-related problem. The 10 mg~     dose is compatible with the known toxicity profile of idarubicin: cumulative cardiotoxicity~     of doxorubicin is noted from 550 mg/m², whereas that of idarubicin is noted from 93 mg/m².~     There is thus a 5.9:1 ratio between their cumulative toxicities. The most frequently used~     dose (and also the weakest one) for the doxorubicin-based CHE is 50 mg. The equivalent of the~     idarubicin dose would thus be: 50 mg (doxorubicin) / 5.9 (doxorubicin/idarubicin ratio) =~     approx. 10 mg of idarubicin.~      It has been already demonstrated that hepatic extraction of idarubicin is better than those~     of doxorubicin and daunorubicin in an animal sarcoma model. In this study, AUC 0-48h and AUC~     0-72h were 1.35 times higher with idarubicin, proving that its intra-hepatic penetration was~     35% higher.~      The randomised phase II PRECISION V study compared conventional CHE (cCHE) with CHE by~     doxorubicin beads (DC Bead®) in patients with HCC. It is currently the largest randomised~     trial on CHE published. The PRECISION V data can be thus used to compare the other studies in~     terms of efficacy and tolerance.~      To continue our preliminary study and the phase I IDASPHERE study, investigators wish to~     assess thus the efficacy and confirm the tolerance of idarubicin-loaded beads for the CHE of~     HCC according to a protocol similar to PRECISION V, as part of a single-arm phase II study.~   "
105554|NCT02185755|"~     Managing blood sugar levels is important for patients with type 2 diabetes (T2DM) to minimize~     health problems and complications. One way for patients to notify doctors and receive~     feedback about their blood sugar management is through an online system. As Internet-based~     glucose monitoring systems (IBGMS) have already been shown to be effective, the investigators~     hypothesize that IBGMS is effective as an intervention even when limiting feedback to~     non-medicine related changes.~   "
105555|NCT02185742|"~     Planning for SUCCESS (Sustained, Unbroken Connections to Care, Entry Services, and~     Suppression) is a project to improve the connection to community care for HIV infected~     persons leaving Fulton County Jail or Atlanta City Detention Center in Atlanta.~      Hypothesis: Participants who receive the intervention will be more likely to link to medical~     care after jail release than similar participants who do not receive the intervention.~      Rationale and objective: This project aims to make sure HIV positive persons leaving jail~     maintain medical care. Case managers will use strength based case management and phone~     texting technology to improve release's connections to care in the community.~      This study will have extensive tracking of outcomes. The key outcome will be whether HIV~     infected participants receiving an intervention experience suppression of their viral load~     after release from jail . The investigators wish to demonstrate the ability to recruit~     participants into the SUCCESS intervention and repeatedly check community medical records to~     see how well their infection is being controlled after they linked to care. Investigators~     also want to conduct a survey at baseline, 3 months and 12 months.~      Investigators will compare the viral load of participants receiving the intervention to~     participants passing through the jail who do not receive the outcome.~   "
105556|NCT02185729|"~     Many patients in the hospital who are malnourished or not eating received intravenous feeding~     or total parenteral nutrition (TPN). Despite improving nutrition, TPN may increase the risk~     of infections and hospital complications. We do not know why TPN increases hospital~     complications, but it may be caused by the high sugar or fat content in TPN solutions. The~     investigators believe that the high sugar and high fat content can limit the ability to fight~     infections and produce stiffness of blood vessels. This study will compare the effect of high~     sugar, high fat content or both on blood sugars, blood vessel function, on blood vessel~     function. The investigators will also compare the effect of different fats (olive oil and~     soybean) in the TPN solution on the risk of infection and blood vessel function on a total of~     12 healthy subjects.~   "
105568|NCT02185573|"~     Three clinical groups will be evaluated. Each group of patients will undergo one method of~     Resin Composite application (multi-layer technique 'control group' - bulk-fill Technique -~     Sonicfill technique). The restored teeth will be followed-up till one year. A comparison is~     going to be made between the three groups in relation to the modified United Sates Public~     Health Service (USPHS) criteria of good restorations.~   "
105631|NCT02184754|"~     Magnetic endoscope imaging (MEI) is already used in colonoscopy in order facilitate scope~     navigation. In this study the use of MEI will be evaluated for small bowel enteroscopy in~     which scope navigation is particularly important. The MEI will be compared with x-ray which~     is still the current gold standard for scope navigation in small bowel enteroscopy.~   "
133440|NCT01820650|"~     This study is designed to observe the long term clinical outcomes of patient-specific knee~     arthroplasty in patients with osteoarthritis.~   "
105557|NCT02185716|"~     Postoperative pain is a significant cause of increased morbidity in the perioperative period,~     leading to patient discomfort and greater hospital length of stay. Laparoscopic~     cholecystectomy associated with significant postoperative pain, a substantial component of~     which is derived from abdominal wall incisions. Ultrasound-guided TAP block increasingly has~     been used for providing pain relief following abdominal surgeries. We designed this study~     with the hypothesis that, administering TAP block with levobupivacaine in laparoscopic~     cholecystectomy provides superior analgesic effects than port-side infiltration.~      In this randomized and double-blind study, 75 patients who are in American Society of~     Anesthesiology (ASA) I-II risk group, between the ages of 20-60, and who will undergo~     elective laporoscopic cholecystectomy operation under general anesthesia will be accepted.~     The patients will be divided into three groups and they will be given postoperative pain~     treatment with patient-controlled analgesia device. In hours of postoperative 1, 2, 4, 8, 12,~     16 and 24,VAS I (superficial pain), VAS II (deep pain), postoperative total analgesic~     proportion, nausea, and vomiting will be recorded under evaluation Postoperative sedation~     score will be recorded (as conscious:0, asleep:1, deep sleep:2 ) in hours of postoperative 1,~     2, 4, 8, 12, 16 and 24.~   "
105558|NCT02185703|"~     The main purpose of the study is to evaluate the impact of treatment with the Chordate System~     S020 (medical device) on acute migraine headache pain.~   "
105559|NCT02185690|"~     MEK162 has shown significant inhibition of tumor growth as a single agent in NSCLC xenograft~     models in mice and human cancer cells in vitro, which have KRAS and/or other mutations. These~     data suggest that MEK162 may provide a potential benefit in cancer indications harboring~     these mutations. MEK162 is currently being investigated in phase I clinical testing and has~     been well tolerated up to an MTD of 45mg BID in cancer patients.~      There has been little change in survival benefit for patients with non-small cell lung cancer~     in recent years. Emerging new treatment options relying on molecular and genetic markers are~     being studied extensively. Thus, there has been a shift to manage non-small cell lung cancer~     with molecular targeted therapies in combination with standard chemotherapy. This study will~     be targeting patients with KRAS mutations.~   "
105560|NCT02185677|"~     The main objective of the study is to compare the score to the Behavioral Dysexecutive~     Syndrome Inventory (BDSI) between Parkinsonian Multiple system Atrophy MSA-P patients and~     cerebellar Multiple System Atrophy (MSA-C) patients matched on disease duration, age (± 3~     years) and sex .~   "
105561|NCT02185664|"~     Cannulation of the internal jugular vein (IJV) for central venous access is a standard~     practice in cardiac surgery. In this study, the authors tested the hypothesis that using an~     ultrasound (US) scanner would increase the success of IJV cannulation and decrease the~     incidence of complications in adult cardiac surgical patients.~      The study will include adult cardiac surgical patients, randomized into two groups (control~     vs. US). In the control group, IJV cannulation will be performed by the conventional landmark~     technique using Seldinger method. In the US group, the course of the IJV will be marked~     before cannulation using a 2 - 4 MHz transthoracic echocardiography probe. The success rate,~     number of attempts, cannulation time and complication rate will be compared for the two~     groups.~   "
105562|NCT02185651|"~     Hypothesis: the effectiveness of treatment of Pompe disease with rhGAA enzyme replacement~     therapy (ERT) is limited at least in part because patients develop antibodies against the~     provided rhGAA enzyme. Treatment with Zavesca® prior to infusion may dampen or eliminate the~     anti-rhGAA immune response in patients receiving ERT, thereby allowing for greater ERT~     efficacy.~      Treatment with Zavesca® before a enzyme replacement therapy (ERT) may decrease the severity~     of, or eliminate infusion associated reactions (IAR) in people with Pompe Disease receiving~     ERT.~   "
105563|NCT02185638|"~     Background:~      Supplementation with the combination of Yerba maté, guarana and damiana (YGD) has been found~     to slow gastric emptying by 15 to 58%, and to induce a substantial weight loss over 45 days~     without changes in diet. Enhanced gastric emptying rate has been shown to reduce the~     satiating effect of food and may thereby promote obesity. Yerba maté and guarana are known to~     contain large amounts of caffeine, resins, saponins and tannins, whereas damiana contains~     ethereal oils, tannins and resins. Caffeine belongs to a class of compounds called~     methylxanthines and epidemiological studies suggest that caffeine might possess weight~     reducing properties. The sympathomimetic properties of caffeine act to some extent through α-~     and β-adrenoreceptors, but most of the sympathoadrenergic stimulation caused by caffeine~     (even in very small doses) acts through the dual ability to antagonise adenosine and to~     inhibit the activity of cellular cyclic nucleotide phosphodiesterase. Stimulation of the~     sympathetic nervous system can cause suppression of hunger, enhance satiety and increase of~     energy expenditure covered in part by increased fat oxidation.~      Aim:~      To evaluate the effect of YGD combination or Akavar 20-50 (A20-50) compared with placebo on:~        1. Acute change in 4-h subjective appetite sensations~        2. Acute change in ad libitum energy intake (EI) 30 minutes post intake~        3. Acute change in serum glucose, insulin, ghrelin and other appetite-regulating hormones~          (glucagon-like peptide-1 (GLP-1), cholecystokinin (CCK))~      Subjects:~      19 , healthy, premenopausal, overweight to obese (BMI between 27 and 32 kg/m2) women(age: 18~     to 45 years).~      Method:~      The study is designed as a 3-way crossover, randomized, placebo controlled, double-blind~     study.~      The bioactive components will be administered as capsules containing YGD or A20-50. The~     placebo capsules will contain rice flower. The subjects will undergo following treatments:~        1. YGD capsules~        2. A20-50 capsules~        3. Placebo capsules~      On each test day the subjects will be instructed to rest in a supine position for 15 minutes~     before dual measures of blood pressure and HR. A blood sample will be taken (baseline). The~     subject's appetite sensations will also be assessed by visual analogue scales (VAS) prior to~     intake of the test compound. Immediately hereafter the subjects will be served the first dose~     of the test compound. Blood samples will be taken at 15 and 30 minutes (time 0) post test~     compound. After 30 minutes post test compound the subjects will be given a standard breakfast~     (2.5 MJ = 598 kcal). Additional blood samples will be taken 15 minutes 30, 45, 60, 90, 120,~     150, 180 and 240 minutes post-meal, together with a VAS appetite score assessment (0, 30, 45,~     60, 90, 120, 150, 180 and 240 minutes).~      Immediately after the last blood collection subjects will be asked to take a second dose of~     the test compound. After 30 minutes the subjects will repeat one VAS score assessment and be~     served an ad libitum lunch.~      Blood samples will be analyzed for insulin, glucose, and appetite regulating hormones such as~     glucagon-like peptide-1 (GLP-1), ghrelin, cholecystokinin (CCK).~   "
105564|NCT02185625|"~     The purpose of this study is to determine whether use of the Safe Delivery smartphone~     application by midwives can reduce excess blood loss from bleeding, and infant death during~     childbirth in Ghanaian women. Moreover, it will be investigated whether the Safe Delivery~     application can increase midwives' knowledge and skills in managing childbirth.~      Fifteen hospitals in Greater Accra, Ghana, will be cluster randomized to either use the Safe~     Delivery application (intervention), or to no intervention (control). In the intervention~     hospitals, midwives will be educated in the use of Safe Delivery. Pregnant women will be~     enrolled at delivery and followed until 7 days postpartum. Data collection will begin July~     2014 and is expected to be finished by October 2014.~   "
105565|NCT02185612|"~     The current literature in social epidemiology and public health suggests that low financial~     savings has an unsurprising negative relationship with subjective well-being, and increases~     the odds of making visits to a healthcare provider, receiving a chronic disease diagnosis,~     and experiencing medical disability. Earn.org is a community-based non-profit based in San~     Francisco with a mission to help low-income workers build lifelong savings habits and~     financial capability. The organization is one of the largest providers of goal-based savings~     accounts or matched savings accounts in the US. The investigators propose to conduct a~     randomized controlled trial to determine the health effects of Earn's savings program.~     Through this trial, the investigators will test three principal hypotheses: (1) Participants~     in the Earn account, as compared to a control group, are hypothesized to demonstrate improved~     scores on mental health scales assessing depression and anxiety.~      (2) Participants in the Earn account, as compared to a control group, are hypothesized to~     experience lower odds of harmful behaviors associated with stress, specifically tobacco and~     alcohol abuse. The investigators hypothesize that the effect on behaviors will be of smaller~     effect size, and more delayed, than the effect on mental health outcomes, judging from~     similar effects observed in the micro-credit literature.~      (3) The mediating variables between Earn account participation and beneficial health outcomes~     will include increased optimism and internal locus of control.~   "
105566|NCT02185599|"~     The study will observe and quantify shifts in colposcopy practice and outcome improvements in~     U.S. community-based cervical screening colposcopy examinations after the introduction of the~     DySIS colposcope with Advanced Cervical Scan.~      The study will collect colposcopy data across multiple sites in two arms; a prospective arm,~     with DySIS being used for the examination and a retrospective arm, with data retrieved from~     patient charts.~   "
105632|NCT02184741|"~     To estimate the safety and efficacy of intravenous immunoglobulin therapy using GB-0998 in~     women with four or more miscarriages by carrying out randomized, placebo-controlled,~     double-blinded study．~   "
105569|NCT02185560|"~     This is a non-interventional, multi center post-authorization safety study that includes all~     patients diagnosed as Unresectable Differentiated Thyroid Carcinoma (DTC) and treated with~     Sorafenib within a certain period. The investigator should have made the choice of treatment~     (NEXAVAR) according with the Japanese Package Insert prior to enrolling the patient in this~     study.~      The enrollment period is of 9 months. The observation period for each patient starts when the~     therapy with NEXAVAR is initiated. Patients will be followed for 9 months or until it is no~     longer possible (e.g. lost to follow-up); this will be considered the standard observation~     period. Those patients, to whom a total of 24 month follow up is possible, information on~     effectiveness including treatment duration and survival status of the patient and of~     keratoacanthoma and/or squamous cell cancer development will be collected.~   "
105570|NCT02185547|"~     This study targets women with moderate depression during pregnancy. We aim to investigate the~     direct effect of the newborn child and the long term consequences on the cognitive~     developement on children who´s mother has been treated with CBT alone or in combination with~     antidepressants.~   "
105571|NCT02185534|"~     This study will be an open-label, randomised, three-way crossover study in healthy male and~     female subjects, performed at a single centre. The objective of the study is to assess the~     bioequivalence between one test formulation (Clopidogrel 75 mg tablet (commercial blister~     from KRKA) and two reference formulations (Clopidogrel 75 mg tablet [Plavix, sourced in US~     and Japan]).~   "
105572|NCT02185521|"~     Philips has developed a new algorithm, called Hemodynamic Instability Rules Based Advisor~     (HIRBA 2.0) system, for the prediction of hemodynamic instability in critically ill patients,~     who were not previously known to be at risk. This algorithm provides with the numerical index~     - Hemodynamic Instability Index (HII) and its trend which are calculated from existing real~     time data derived from patient's current hospital stay such as heart rate and blood pressure,~     labs, and Admission - Discharge- Transfer (ADT) data to help healthcare providers obtain~     information about patient's status and make clinical decisions.~      The aim of the study is to determine if the patient clinical information, displayed in the~     form of HII, can prompt possible patient hemodynamic status change and trigger earlier~     clinical care team response. Study will also identify if the use of the Philips new algorithm~     called Hemodynamic Instability Rules Based Advisor (HIRBA 2.0) can improve outcomes for~     patients admitted to the intensive care units (ICUs).~      During this study, upon patient admission to the ICU clinical data collection will begin.~     Data that will be pulled during the study includes: vital signs, medications, reason for~     admission to the ICU, results from blood work, treatments that patient may receive.~      Research subjects will not be asked to do anything as far as specific activities expected to~     be accomplished during study participation. Subjects will be involved in the study only~     during their stay in ICU. HII information will be visible to clinicians, taking care of this~     patient only during his/ her stay in the study unit. Patients will be randomized into HII arm~     (treatment group) and into no-HII - standard treatment arm (control group).~      Study team will collect patient information and have the ability to view the HII for subjects~     randomized into HII group arm. For subjects randomized into the control arm study team will~     collect patient's clinical information but the clinical care team will not have the ability~     to view the HII.~      Once patient leaves the ICU the study team will collect information on the remainder of~     patient's hospital course including date of hospital discharge. All collected data will be~     then fully de-identified and released to Philips for analysis.~      This clinical investigation is designed to answer several key questions including:~        1. Are the performance metrics the same when the algorithm operates in the live host as it~          does on retrospective data?~        2. Are there opportunities for improvements in the host implementation; including graphical~          rendering of the HII information and creation of an alert?~        3. Are the predicted workflows which result from the use of the HII clinically acceptable?~        4. Is there a difference in the clinical measures for patients who have HII displayed when~          compared to those who do not?~        5. What is the optimal care process which should be followed based on the presence of the~          indicator?~   "
105573|NCT02185508|"~     The purpose of this study is to determine the relation among: (1) changes in voltage and~     amplitude of trans-operatory records obtained through the use of Intra-operative~     Neurophysiological Monitoring (IONM), and (2) clinical outcomes; of patients who underwent 1~     or 2 levels surgical decompression at lumbar spine.~      IONM is the use of real time neurophysiological techniques during spinal surgeries. The~     modalities included in this study are:~        -  Somatosensory evoked potentials (SSEPs).~        -  Trans-cranial electric motor evoked potentials (tceMEPs).~        -  Spontaneous electromyography (EMG).~      Clinical outcome of the patients will be assessed through a careful evaluation of clinical~     data, as well as the application of three outcome scales:~        -  Oswestry Disability Index 2.1a~        -  Visual Analogue Scale for Pain~        -  Patient's Overall Impression of Change~   "
105574|NCT02185495|"~     Imaging procedures including chest X-ray and low-dose computed tomography may be effective in~     lung cancer early detection. Yet it is unknown whether low-dose computed tomography combined~     with computer aided detection （CAD) is more effective than LDCT in screening of early lung~     cancer.~   "
105575|NCT02185482|"~     There is a high prevalence of depression in patients with diabetes mellitus. Depression has~     been shown to be associated with poor self-management (adherence to diet, exercise, checking~     blood glucose levels) levels in patients with diabetes.To determine whether enhancing quality~     physician's care for depression improves both depression and diabetes outcomes in patients~     with depression and diabetes.~   "
105576|NCT02185469|"~     There are multiple ways to treat retinal detachment, the aim of this study is to compare the~     amount of corneal endothelial cell loss after pneumatic retinopexy in comparison to~     vitrectomy.~   "
105577|NCT02185456|"~     Bacterial vaginosis (BV) is the commonest form of vaginitis worldwide, affecting millions of~     women. Unfortunately, recurrence rates of symptomatic BV remain extremely high, 30% at three~     months and 70-80% within a year. Given the paucity of information and data regarding~     pathogenesis of BV, the etiopathogenesis of recurrent bacterial vaginosis remains unknown.~     Accordingly, reliable, proven treatment regimens for Recurrent Bacterial Vaginosis (RBV) are~     not available.~      In 2013, the investigators published two manuscripts documenting a new qPCR based approach to~     BV diagnosis and potentially prognosis. The method (LbRC) measures the content of~     lactobacilli in vaginal samples, relative to total bacterial load. The first goal of this~     study are to validate that this metric is a reliable diagnostic of BV, by determining~     sensitivities and specificities relative to Nugent scores and Amsel criteria of healthy women~     and BV patients. A high LbRC score (3-4) corresponds to a healthy state. The second goal is~     to determine whether empirically determined low LbRC scores (1-2) in BV patients after~     treatment are indicators of recurrence, and whether preemptive action, based on this score,~     with more intensive treatment, delays or eliminates recurrence in these patients.~   "
105578|NCT02185443|"~     This is a Phase II study to determine the efficacy of SBRT to treat liver metastases in~     patients with Colorectal Adenocarcinoma, Carcinoma of the Anal Canal and Gastrointestinal~     Neuroendocrine Tumors that are not amenable to surgery. Patients should have no evidence of~     extra-hepatic disease or have disease that is planned to be treated with curative intent.~      Therefore, SBRT is being considered as a potentially curative procedure.~   "
114653|NCT02066727|"~     Hypothesis: Dexmedetomidine as an adjuvant of lidocaine can decrease the median effective~     concentration(EC50) of lidocaine for obturator nerve block during transurethral resection of~     bladder tumor~   "
105579|NCT02185430|"~     COPD is often associated with the airflow limitation and the pulmonary hyperinflation. During~     the one-lung ventilation (OLV), COPD patients' physiologic dead space increases and~     hypercapnia may develop. In addition, an alveolar overdistention by the pulmonary~     hyperinflation would divert pulmonary blood flow and impair arterial oxygenation.~     Dexmedetomidine has both vasoconstricting and vasodilatatory effects on a peripheral~     vasculature and a smooth muscle but its effects on bronchial smooth muscle is unknown. The~     investigators will evaluate the effects of dexmedetomidine (bolus of 1.0 μg kg-1 over 10 min~     followed by a continuous infusion at 0.5 μg kg-1 h-1 infusion during one-lung ventilation) as~     bronchodilator in COPD patients when administered during surgery with the one lung~     ventilation. If result successfully shows the effect of dexmedetomidine as a predominantly a~     vasodilator on bronchial tree, the investigators study can support the dexmedetomidine as a~     vasodilator for pulmonary vessels and bronchial smooth muscle and as an excellent adjunct to~     anesthetic agents in COPD patients during the OLV.~   "
105580|NCT02185417|"~     The purpose of this study is to determine whether chlorthalidone is more effective than~     hydrochlorothiazide at preventing cardiovascular outcomes in Veterans over age 65 with~     hypertension. Both medications are thiazide-type diuretics that have been used for more than~     50 years and are considered first-line treatment for hypertension. Patients currently~     prescribed hydrochlorothiazide will be randomized to either continue taking~     hydrochlorothiazide or to receive chlorthalidone, and followed for major cardiovascular~     events, such as myocardial infarction (MI) and stroke. The study will use a new, efficient~     and less expensive study design termed 'point of care', in which study operations will be~     conducted centrally and patient data will be collected passively through the electronic~     medical record.~   "
105581|NCT02185404|"~     The objective of this research is to test a passive shoe capable of to test the capability of~     a mobile shoe to enhance gait improvements in individuals with asymmetric walking patterns.~     Individuals with central nervous system damage, such as stroke, often have irregular walking~     patterns and have difficulty walking correctly. Recent research has shown that using a~     split-belt treadmill can create after-effects that temporarily correct the inefficient~     walking patterns. However, the corrected walking pattern does not efficiently transfer from~     the treadmill to walking over ground. The Gait Enhancing Mobile Shoe (GEMS) may allow a~     patient to practice walking in many different locations, such as their own home, which we~     hypothesize will result in a more permanent transfer of learned gait patterns. To enable~     long-term use, our proposed shoe design is passive and uses the wearer's natural forces~     exerted while walking to generate the necessary motions.~   "
105582|NCT02185391|"~     Coronary Heart Diseases are responsible for a high number of deaths in Germany. To determine~     the risk factors secondary prevention is of great importance. After their residence in~     rehabilitation centers patients often get rid of newly required skills. In addition to that~     parameters like BMI, blood pressure and cholesterol level return to their initial value.~      Using an Audience Response System (ARS) during oral presentations in rehabilitation centers~     should improve the learning effect of patients. Furthermore patients will receive motivating~     telephone calls in the follow-up. These methods should lead to a sustainable improvement of~     learning effects, health care behavior and quality of life.~   "
105583|NCT02185378|"~     One-lung ventilation, even in patients with healthy weight, causes an impairment in~     gas-exchange and respiratory mechanics. We hypothesized that oxygenation during the one-lung~     ventilation in obese patients would be improved by applying inverse-ratio ventilation,~     reducing atelectasis in the dependent lung and resulting in reduced shunt. Because of the~     restrictive ventilatory effects of obesity, these patients often show a decreased functional~     residual capacity and decreased expiratory reserve volume, leading to an overall decreased~     tidal volume. These reduction leads to arterial hypoxemia, V-Q mismatch and Rt to Lt~     shunting. There are few studies on the one lung ventilation in obese patients about this~     prolonged inspiratory time ventilatory method. We plan to investigate the effect of this~     ventilation method in obese patients during one lung ventilation.~   "
105584|NCT02185365|"~     One of the leading causes of hip arthritis is developmental dysplasia of the hip (DDH). DDH~     can lead to major damage in the hip joint and may result in hip arthritis later in life.~     Patients recruited into this study will be undergoing corrective hip surgery within the next~     6 months with a goal of preventing further hip problems down the road. This study is being~     done to see how well a newer type of Magnetic Resonance Imaging (MRI) detects hip cartilage~     damage compared to an older but well validated MRI method.~   "
105585|NCT02185352|"~     The primary objective of A-PLUS trial is to evaluate and compare the efficacy of induction~     BEEP (bevacizumab preconditioning followed by etoposide and cisplatin) followed by whole bran~     radiotherapy (WBRT) with WBRT alone in the controlling of brain metastases (BM) in metastatic~     breast cancer (MBC) patients who have not previously received WBRT.~      In past 2 years, the research team has demonstrated that BEEP regimen is a highly effective~     treatment for brain metastases of breast cancer progressing from WBRT by a multi-center phase~     II study (ClinicalTrials.gov Identifier: NCT01281696). The basic concept of preconditioning,~     as referred to starting bevacizumab 1 day before chemotherapy, is that the effect of~     bevacizumab induced tumor vascular normalization takes time to mature.~      The investigators hypothesized that as induction BEEP decreased the size of brain tumors, the~     effectiveness of WBRT would be maximized. The investigators expect this integrated approach~     will do greater benefit to MBC patients with BM, irrespective of subtype.~   "
105586|NCT02185339|"~     The primary objective of the current study is to compare intraoperative respiratory mechanics~     in patients receiving laparoscopic renal surgery under deep neuromuscular blockade (dNMB) and~     under moderate neuromuscular blockade (mNMB). In addition, we will compare intraoperative~     hemodynamics and postoperative pulmonary function between the two groups.~   "
105587|NCT02185326|"~     The effect of use of the microflare down regulation protocol on the outcome of the IVF/ICSI~     cycles in poor responders~   "
105595|NCT02185222|"~     As recommended allowance of oral vitamine D are unable to ensure the recommended serum~     concentration of vitamine D, the purpose of this study is to show that a dose of vitamin D3~     higher than the recommended allowance may slow the cognitive decline of patients with a~     memory complaint.~   "
105596|NCT02185209|"~     The purpose of this study is to investigate if the use of systemic adjunctive antibiotics in~     the treatment of periimplantitis is needed.~   "
105588|NCT02185313|"~     The long-term goal of this research is to advance the investigators knowledge of how the~     cerebellum a) controls gaze holding and compensates for impaired gaze stability and b)~     modulates vestibular information that is forward-ed from the labyrinth and brought to~     perception. While gaze holding is stable also at large angles of gaze eccentricity in healthy~     human subjects, patients with chronic (degenerative) cerebellar disorders are inable to~     stabilize gaze in eccentric positions, resulting in eye drift towards primary~     (straight-ahead) position and com-pensatory gaze-evoked nystagmus. When returning to primary~     position, a compensatory nystagmus into the opposite direction (called rebound nystagmus) can~     be observed in these patients. Unlike patients with de-generative cerebellar disorders,~     patients suffering from ischemic of hemorrhagic stroke within the cerebellum present with~     acute deficits of gaze holding and verticality perception.~      While a linear relationship between the amount of eye velocity drift and eccentricity of eye~     position has been proposed in healthy human subjects, others suggested non-linear behaviour.~     The strategy of this research is to characterize gaze holding and verticality perception in~     healthy human subjects and patients with either acute (ischemic or hemorrhagic) or chronic~     degenerative cerebellar disorders and to relate eye movement findings with structural imaging~     of the cerebellum. The investigators will therefore analyze key cerebellar structures with~     regards to loss of volume and relate these imaging findings with the participants' ability to~     hold gaze and es-timate direction of vertical. The investigators hypothesize that besides the~     flocculus other vestibulo-cerebellar structures are involved in gaze holding and verticality~     perception in humans.~   "
105589|NCT02185300|"~     Dolutegravir (DTG) is an HIV-1 integrase inhibitor approved in the United States, Canada,~     Australia and EU. A dispersible tablet has been developed for pediatric use as an alternative~     to the granule formulation, already in development, and the approved film-coated tablet. This~     is a single-center, randomized, open-label, 5-way crossover study in healthy adult subjects.~     The study will evaluate the relative bioavailability of five dosing regimens: 20 mg DTG~     pediatric granules (Treatment A) and of DTG 20 mg dispersible tablets (DTG 20 mg DT) after~     dispersed in: low mineral content(LMC) water (Treatment B); dispersed in CONTREX™ mineral~     water (Treatment C); dispersed in low mineral content water and consumed after standing for~     30 minutes (Treatment D) and dispersed in CONTREX mineral water and consumed after standing~     for 30 minutes (Treatment E). Safety evaluations and serial PK samples will be collected~     during each treatment period. A follow-up visit will occur 7-14 days after the last dose of~     study drug. CONTREX is a trademark of Nestlé Waters Corporation.~   "
105590|NCT02185287|"~     Aim of the study protocol is to evaluate in a prospective investigation of health statistics~     if the dysfunctions of the lower urinary tract in women aged between 18 and 40 years may be~     the result of past urinary pediatric dysfunction. The aim is to be able to identify the risk~     conditions which, if treated properly in early childhood, to help avoid debilitating~     problems that manifest themselves as adults and possibly to implement a strategy of~     prevention.~      The choice of this age group is due to the fact that it allows for easier retrieval of data,~     as it is presumed that the concerned can more easily remember their history of pediatric and~     / or have parents still young enough to ask for such information. The problems of urinary~     disorders in childhood era have been the subject of increased attention by pediatricians from~     the end of the 70s, therefore, history taking may be more complete.~      A study by Fitzgerald evaluated female subjects with mean age of 56 ± 9 years, and therefore~     our study aim is to investigate an age group that does not appear in the literature to~     supplement these findings, already reported.~      Ultimate goal is the need to raise awareness of Pediatric Urologists to interact with adult~     Urologists in order to implement a shared strategy for the management of patients with~     problems of impaired bladder function in order to improve the future lower urinary tract~     function.~      Materials and Methods: A self administered questionnaire will be used in accordance with the~     guidelines of the International Children's Continence Society. The questionnaire consists of~     two parts: the first explores the history of urological clinic patient until the age of 14,in~     order to evaluate any symptoms reported in a specific category of typical dysfunction of~     childhood; the second part refers to the present together with urological disorders of sexual~     function which, as emerges from the data of the literature may be of relevance urological~     diseases detectors. The data obtained will then be subjected to statistical calculations by~     which will evaluate the significance of the symptoms present in childhood in relation to~     their penetrance in various forms of adult diseases dysfunctional bladder and / or sexual~     abuse, with the prediction of the evolution of the same.~      The questionnaire is anonymous in order to protect privacy. The questions that comprise it~     have been partly extracted from the questionnaire validated by the International Children's~     Society Continent and partly made by the authors of this study on the basis of the scientific~     evidence.~      Patients will be recruited from the outpatient clinic of the Urogynecology Urology Clinic,~     University of Perugia, while the healthy controls will be recruited by submitting a~     questionnaire to the women chosen to sample a healthy population of Graduate Schools found in~     the framework of Urology, Pediatrics and Pediatric Surgery, University of Perugia.~      The Investigators defined that the statistically significant number of healthy and~     pathological subjects can not be less than 200 units per reference category.~      The time duration of the collection of anamnestic data depend on the ability of the authors~     of this research in finding the subjects to be analyzed.~      There are no conflicts of interest to declare, no drugs or medical equipment will be tested .~   "
105591|NCT02185274|"~     Gender identity disorders (also known as transsexualism) is defined as a condition in which a~     person with apparently normal somatic sexual differentiation is convinced that he or she is~     actually a member of the other sex. Most patients therefore undergo so called cross-sex~     hormone treatment. Treatment protocols follow international consensus statements but vary~     considerably between different centres and countries since no prospective and controlled~     trials are available on this subject and recommendations are mainly based on retrospective~     data analysis and experience of the individual centres. Applying high doses of testosterone~     to biological females and vice versa high doses of estradiol to biological males definitely~     impacts myriads of body functions, from which it has to be assumed that only a minority has~     already been elucidated so far. Especially in male-to-female-transsexuals there seems to be~     an increased risk for the development of mood disorders and cardiometabolic comorbidities. In~     this multi-center observational study we want to investigate, if there is any difference with~     regard to these outcomes, according to the varying standards of cross-sex hormone treatment~     between the different centers. Different outcome measures described below will be assessed~     each time during routine visits at the different centers.~   "
105592|NCT02185261|"~     This study aimed to evaluate the efficacy of interferon α among patients undergone~     unmanipulated blood and marrow transplantation following day 60 post-transplantation who were~     minimal residual disease positive after transplantation.~      Hematopoietic stem cell transplantation (HSCT) is an effective treatment option for acute~     leukemia and many other hematological malignancies. However, post-transplant relapse can~     occur in some patients, and the prognosis of these patients is usually very poor.The~     persistence or recurrence of minimal residual disease (MRD) in the post-transplant period is~     an independent risk factor of relapse. Therefore, MRD monitoring can be used to screen~     patients with a high risk of relapse to provide timely intervention and prevent~     post-transplant relapse.Interferon α-2b exerts a relatively strong immunomodulatory effect.~     It can kill acute leukemia (AL) cells by regulating T-cell and/or natural killer cell~     functions.Consequently, interferon α-2b may have potential therapeutic value for AL patients~     with MRD-positive after transplantation.~      The study hypothesis:~      Prevention of relapse using interferon α-2b following hematopoietic stem cell transplantation~     in patients with standard risk acute leukemia can reduce relapse rate.~   "
105593|NCT02185248|"~     The objective of this study was to determine the effectiveness of a novel Wellness Action~     Plan aimed at 1) improving parent recall of diet and activity plans 2) increasing~     follow-through with plans and 3) aiding parents in identifying their child's weight category.~   "
105594|NCT02185235|"~     Female pelvic floor disorders (PFDs) include urinary incontinence,pelvic organ prolapse~     (POP), and fecal incontinence—which often occur together.~      Pelvic floor disorders impair multiple aspects of the life quality, including the sexual~     function of women.~      Surgery became the first choice of treatment, however, and not until 1980s was the renewed~     interest in conservative therapies.~      This may be because of higher awareness among women and cost of and morbidity after surgery.~      The conservative treatment included pelvic floor muscle training, electrical stimulation,~     vaginal cones, and biofeedback.~      The outcome was up to 35~70 % improved rate as the literature before. Current guidelines~     recommended conservative management as a first-line therapy. However, there was no consistent~     consensus on this issue due to variations in stimulation parameters、adjuvant concurrent~     modality or duration of treatment course, and insufficient result about large and long term~     follow up of randomized- controlled studies.~      Therefore, the investigators try to conduct one randomized-controlled trial to evaluate the~     efficacy of conservative treatment for Pelvic floor disorder (Pelvic organ prolapse, urinary~     incontinence, chronic pelvic pain etc.).~      At the aspect of Quality of life, our studies tried to focus on the different domains of~     pelvic disorder and sexual quality by means of validated questionnaire more objectively.~   "
105597|NCT02185196|"~     Background:~        -  Burden: Pneumonia is the leading cause of morbidity and mortality in under-five~          children, particularly in developing countries.~        -  Knowledge gap: Although many studies have reported an association between vitamin D~          deficiency and pneumonia, there is lack in information on its therapeutic impact, i.e.~          the impact of vitamin D supplementation in the management of childhood pneumonia.~        -  Relevance: Vitamin D plays an important role in modulating the innate immune response~          against infections. We, therefore, propose to conduct this study to assess the impact of~          vitamin D supplementation, in addition to standard antibiotic and supportive therapy, on~          the outcome of severe childhood pneumonia.~      Hypothesis: The investigators hypothesise that in the management of hospitalized severe~     pneumonia in under-five children, vitamin D3 supplementation, as an adjunct to the standard~     antibiotic and other supportive therapy, will hasten recover from severe pneumonia and may~     thereby shorten duration of severe pneumonia and also reduce the risk of new episode of~     pneumonia.~      Objectives: The objective of the investigators study is to assess the clinical benefit of~     oral supplementation of vitamin D3, in addition to standard antibiotic and other supportive~     therapy, to hospitalised, under-five children with severe pneumonia.~      Methods: This would be a randomised, double blind, controlled clinical trial (RCT). Children~     of either sex, aged 3-59 months, attending the Dhaka Hospital of icddr,b, with clinically~     diagnosed severe pneumonia will comprise the study population. Eligible children will be~     allotted a sequential study number, which will have been previously assigned to vitamin D or~     placebo in accordance with the randomisation. The study staff and mothers/ caregivers of the~     children will be blinded as to whether vitamin D3 or placebo has been added to their child's~     diet. Infants aged 3-5 months will receive breast milk and/or infant formula, and those 6~     months or older will receive Milk Suji as a complementary food. Vitamin D3 supplementation~     will be given on five consecutive days, from the day of enrolment in addition to standard~     antibiotic and other supportive therapy.~      Outcome measures/variables:~      Primary outcome measure will be time to resolution of severe pneumonia.~      Secondary outcome measures will be duration of hospitalization, fever, tachypnoea, chest in~     drawing, hypoxia, lethargy and inability to feed during hospital stay and as well as new~     episode of pneumonia after discharge.~   "
105598|NCT02185183|"~     Oral administration of Alequel, a mixture of proteins derived from the patient's bowel will~     be tested in patients with inflammatory bowel disease.~   "
105599|NCT02185170|"~     The aim of this study is divided in 4 different steps:~        -  the first step has two different purpose: assess the impact of the storage medium of~          fresh prostatic chips on fluorescence signal and adjust the entire chain~          (immunolabelling,counter-stain and imaging),~        -  the second step is the adaptation of immunolabelling protocol on histopathology slides,~          using fresh prostatic tissue,~        -  the third step is to validate the use of:~             1. the medical device created by the FEMTO-ST institute use for the detection of~               fluorescence signal on fresh tissue,~             2. the Light-CT scanner use for tissue structural observation.~        -  the four step is to check the preservation of morphological structure of tissue under~          the effect of laser excitation from the medical device.~   "
105600|NCT02185157|"~     The training of a secondary task while walking, whether it is reasoning activities, memory or~     motor tasks, may enhance automation, walking performance, and postural control and, thus,~     minimize the risk of falls influenced by the walking patterns variability. However, the~     literature is scarce regarding the influence of dual-task training on changes in gait~     parameters.~      The purpose of this prospective, blinded randomized controlled trial is to compare the short-~     and long-term effects of dual-task and aerobic training on gait stride variability and~     superior cerebral functions of independent community-dwelling elderly women.~      The participants will be randomly allocated into either experimental or control groups.The~     experimental group will undertake 50 minutes/day of dual-task training, three times/week over~     12 weeks, totaling 36 sessions, whereas the control group will receive the same doses of~     aerobic training. At baseline, after 18 and 36 sessions, and 12 weeks after the cessation of~     the interventions, researchers blinded to group allocations will collect the outcome~     measures.The interventions will be delivered by trained physical therapists.~      Primary outcome will include gait stride variability, which will be assessed by a movement~     analysis system: the GaitRite® system, during cognitive and motor dual-tasks, at both normal~     and fast speeds. Secondary outcome measures will include a battery of global and specific~     cognitive function tests.~      The findings of this trial may help better understand whether cognitive-motor interventions~     with older adults, when compared to traditional aerobic training, would result in greater~     improvements in gait under dual-task conditions and lead to improvements in cognitive tasks.~     Furthermore, the findings could potentially bring important insights regarding the impacts of~     improvements in walking abilities and cognition.~   "
105601|NCT02185144|"~     The PATH for Triples (PFT) Study is an effectiveness trial comparing a nurse health navigator~     (NHN) model for HIV+ persons with severe mental illness and substance abuse (i.e., triply~     diagnosed) with Treatment as Usual (TAU). The team completed a Phase II trial of the nurse~     health navigator model for HIV+ persons with severe mental illness that showed the~     intervention was effective. The investigators are now testing the intervention in a real~     world setting with patients recruited from psychiatric and substance abuse inpatient units in~     Philadelphia using a longitudinal design. The intervention is set up as a cascade where~     non-adherent patients receive additional visits from the study nurses. It is hypothesized~     that patients assigned to the NHN will have better medication compliance, reduced viral loads~     and improved CD4 counts compared to patients assigned to TAU. It is also hypothesized that~     the PFT intervention group will be more cost effective compared to TAU. This group of triply~     diagnosed patients are at very high risk of negative health outcomes and secondary~     transmission of HIV and, therefore, the study is of high public health significance.~   "
105602|NCT02185131|"~     Mirtazapine is a non-SSRI (selective serotonin reuptake inhibitor) medication with a unique~     structure and mechanism of action. Recent study results suggest that mirtazapine may be more~     effective and faster acting than other antidepressants. Levels of alcohol use have been shown~     to be associated with levels of depressive symptoms among comorbid populations. Our own~     recent open label pilot study suggested robust within-group efficacy for mirtazapine for~     decreasing both the drinking and the depressive symptoms of persons with co-occurring alcohol~     dependence/major depressive disorder (AD/MDD). However, no placebo control group was employed~     in that study, so between-group efficacy versus placebo could not be assessed. The current~     grant submission proposes to conduct a first double-blind, placebo-controlled study to~     evaluate the efficacy of mirtazapine versus placebo for decreasing the alcohol use and~     depressive symptoms of persons with comorbid AD/MDD. If the results of this proposed~     double-blind pilot trial are promising, then the effect sizes found in this proposed study~     will be used to help design an adequately-powered R01 treatment trial to definitively test~     the efficacy of mirtazapine in this comorbid population.~   "
105603|NCT02185118|"~     Sepsis is a major cause of death in intensive care units. Despite the investigators improved~     understanding, which has reduced the risk of dying with sepsis, the number of people who die~     each year continues to increase due to an overall increase in the number of cases.In our~     previous study, the investigators have showed that 100% oxygen or 0.5 minimum alveolar~     concentration (MAC) isoflurane/sevoflurane in 60% oxygen protect mouse macrophage cell line~     against in-vitro sepsis induced by lipopolysaccharide (LPS).~      In this study, the investigator hypothesized that treatment of 100% oxygen or 0.5 MAC~     isoflurane/sevoflurane in 60% oxygen protected against clinical in-vitro models of sepsis~     induced by LPS or plasma from septic patients.~   "
105604|NCT02185105|"~     The study hypothesis is there is no difference in the clinical performance between the test~     and control lenses, in particular in lens stability, toric mislocation, comfort ratings and~     anterior segment ocular health findings.~   "
105606|NCT02185079|"~     Procedural skills are an important determinant of clinical outcomes for certain patient~     groups. Training for procedural skills in the medical profession is still largely based on an~     apprenticeship model. For example, trainees learning to perform epidural anaesthesia do so by~     practicing on patients under direct supervision by seniors (consultants or senior~     registrars/residents). Learning a complex and high risk procedural skill on patients is not~     ideal.~      As medical training moves from apprentice based to competency based training along and as for~     the number of clinical learning opportunities for trainees is less, it is necessary to~     develop a comprehensive training programme which enables effective and efficient learning~     without compromising on patient safety. Metrics-based performance based progression has shown~     to improve clinical performance not only in novices but also in experts.~      We envisage a standard methodology which could address the deficiencies in procedural~     training currently. This would entail development and validation of a set of metrics for a~     particular procedure, evaluation of a proficiency based progression training programme based~     on those metrics to and demonstration of improved clinical performance and clinical outcome~     associated with that programme. Although elements of this end -end approach have been~     demonstrated previously for various procedures, we propose to apply this methodology in its~     entirety to placement of a lumbar epidural catheter for analgesia for patients in labor. To~     date we have developed and are validating a set of metrics for this procedure. Proficiency~     based training leading to better procedural skills leading to better patient outcomes has not~     been studied so far. Epidural analgesia during labor lends itself as an excellent model for~     evaluating the whole process. It has a specific procedural skill which is closely linked to~     patient outcome which is measurable and occurs in finite time interval.~      The hypothesis of the study is that in novice anaesthetic trainees, training with metrics~     based performance based progression in addition to improving the clinical performance will~     also reduce the failure rates of labor epidural analgesia to 5% when compared to 25% achieved~     by conventional training.~   "
105607|NCT02185066|"~     This study is designed to evaluate safety and pharmacokinetic properties of the two~     treatments, the administration of CJ-30056 and the co-administration of atorvastatin and~     metformin XR, in healthy volunteers.~   "
105608|NCT02185053|"~     This is a Phase II, Single-Blind, Placebo-Controlled, Sequential Treatment, Multiple~     Ascending Dose Study to Evaluate the Safety and Tolerability of CPC-201 in Patients with~     Alzheimer's Disease Type Dementia.~   "
105609|NCT02185040|"~     The purpose of this study is to determine whether CC-220 is effective for the treatment of~     skin, joint and serological manifestations of systemic lupus erythematosus.~   "
105610|NCT02185027|"~     The arrival on the market of direct oral factor Xa and factor IIa inhibitors (dabigatran~     (Pradaxa®), rivaroxaban (Xarelto®), apixaban (Eliquis®) and others soon to come) raises novel~     questions among clinicians confronted with the emergency management of patients treated with~     these new drugs. It is likely that these new oral anticoagulants (NOACs) will eventually win~     a significant market share in the indications secondary prevention of venous thromboembolism~     and prevention of cardioembolic events in patients with nonvalvular atrial fibrillation, due~     to their net clinical benefit and their practicality of use compared with vitamin K~     antagonists (VKAs).~      However, despite the fact that NOACs reduce the incidence of intracranial bleeding by about~     half compared with VKAs, the risk remains significant; furthermore, in clinical trials, these~     drugs had little or no effect on reducing the incidence of major extracranial bleeding. In~     everyday practice, where the indication could be expanded to unselected populations and due~     to a potential for misuse, it is likely that the incidence of bleeding complications will be~     higher than that reported in clinical trials. Indeed, the numerous alerts emanating from~     regulatory agencies in various countries (US, Australia, etc.) bear witness to this, and~     should serve as a reminder that these anticoagulants have a real potential for bleeding~     complications and, in the absence of an antidote, there is no validated management strategy.~      Furthermore, as these drugs can be prescribed for months or years, patients may eventually be~     exposed to situations at high hemorrhagic risk, such as emergency surgery or invasive~     procedures, trauma, etc. Analysis of data from the RE-LY trial (dabigatran versus warfarin in~     patients with atrial fibrillation) showed that during the two years of follow-up,~     approximately 25% of the patients underwent an invasive procedure, ranging from pacemaker~     insertion to major surgery. Thus, a large proportion of patients treated with NOACs are~     concerned by this issue.~      In anticipation of a gradually increasing influx of patients in a critical situation (active~     bleeding or need to rapidly secure hemostasis before an invasive procedure), it is urgent to~     define the conduct to adopt based on the experience gained from the earliest cases. This is~     the objective of the French-speaking GIHP-NACO observatory set up by the GIHP (French Working~     Group on Perioperative Hemostasis).~      For the moment, then, the management recommendations derive from expert opinions based on~     pharmacokinetic data and on the partial correction of NOAC-induced hypocoagulability by~     various nonspecific procoagulants (non-activated or activated prothrombin complex~     concentrates, recombinant factor VIIa). These procoagulants are currently used in an~     empirical manner to control bleeding, with as many successes as failures reported in the~     literature, and their benefit-risk ratio in these patients is therefore uncertain.~   "
105611|NCT02185014|"~     This study will evaluate the long term efficacy, safety, and tolerability of repeated~     administration of adalimumab in subjects with Crohn's disease.~   "
105612|NCT02185001|"~     Background: The forces involved in a patella dislocation event can cause significant~     collateral damage involving the articular cartilage of the patella femoral joint. As a~     result, prevention of recurrent patella dislocation and the associated disability and~     morbidity has generated significant interest in the orthopedic community. Historically,~     nonoperative treatment for first time patella dislocation has been problematic due to high~     redislocation rates. Nonoperative protocols generally involve bracing and/or immobilization,~     followed by physical therapy (1). Surgical approaches to recurrent patella dislocation, both~     soft tissue and boney realignment operations, have also had mixed results, including low~     success rates, associated complications, and variable rates of return to functional activity~     (2,3,4). This study is intended to compare the outcomes of a relatively low-risk Medial~     Patellofemoral Ligament (MPFL) direct repair procedure to conservative treatment.~      Methods/Design: This study is designed as a two arm randomized prospective trial.~     Approximately fifty subjects will be randomly assigned to either a surgical or non-operative~     arm by means of a computer randomized allocation program. All subjects will have X-Ray Images~     and Magnetic Resonance Imaging (MRI) to determine the site of the MPFL damage, and to~     determine if any excluding conditions exist. Subjects randomized to the surgical group will~     have repair of the MPFL. Routine aftercare will consist of physical therapy in a clinic that~     has agreed to follow our protocol. Subjects randomized to the nonoperative group will receive~     2 weeks of patellar immobilization, followed by patellar stabilization bracing with physical~     therapy for approximately 12 weeks. Physical therapy will progress through five phases with~     the goal of gait normalization, full range of motion and return to sport. Both arms will be~     given outcome questionnaires and physical activity assessments before treatment, and at one,~     three, six, twelve, and twenty four month intervals.~      Discussion: This prospective randomized trial will investigate the results of direct repair~     of the medial patellofemoral ligament and conservative treatment by applying subjective~     outcome measures (Kujala scores), and exam findings to determine MPFL functional restoration~     or redislocation. Subjects will be examined in the clinic setting at 10 days, one month, and~     six months post trauma. Any reported recurrent dislocation or subluxation event will be~     documented during recovery. All subjects will receive merchant x-ray views at 3 months with~     manual lateral translation of the patella.~   "
105613|NCT02184988|"~     The purpose of this study is to demonstrate the safety of multiple doses of DWP-450~     (Botulinum purified neurotoxin, Type A) Injection in treatment of moderate to severe~     glabellar lines in adult subjects.~   "
105614|NCT02184975|"~     The treatment of high grade Cervical Intraepithelial Neoplasia (CIN) 2, 3 is defined~     according to the colposcopic evaluation of the patient. In case colposcopy findings are~     satisfactory (visible squamocolumnar junction), both ablative and excisional methods are~     adequate. In the middle of the 20th century, lateral hemostatic sutures were added to the~     cold knife conization surgical technique to reduce blood loss. Some authors recommend that~     these branches should be ligated, but it remains unclear whether these sutures are actually~     effective in reducing bleeding.This study compared blood loss during cold knife conization of~     the cervix with and without lateral hemostatic sutures.~   "
105615|NCT02184962|"~     The aim of this study was to investigate the levels of RANKL and Osteoprotegerin, and their~     relationship in gingival crevicular fluid of post-menopausal women with~     osteoporosis/osteopenia and chronic periodontitis simultaneously and evaluate the effect that~     the use of bisphosphonates in periodontal disease.~      Study hypothesis:~      The osteoporosis / osteopenia in postmenopausal women patients with periodontal disease~     affect the ratio RANKL / OPG in gingival crevicular fluid samples favoring osteoclastogenesis~     processes ~   "
105616|NCT02184949|"~     The relationship between annual procedural volume and patient outcome remains a debated issue~     in the field of interventional medicine. An under-explored issue in a UK context is whether~     or not such a relationship exists for percutaneous coronary interventions (PCI). In recent~     years, this procedure has replaced thrombolysis as the standard intervention method used in~     UK hospitals for widening patients' obstructed coronary arteries. However, the actual number~     of such procedures currently undertaken annually remains variable across hospitals where~     these interventions are performed. The UK's National Institute for Health and Care Excellence~     has consequently called for research into whether such differences in volume play any role in~     patient outcome for this particular procedure. The current study is intended to address that~     research need, and will do so by looking at whether the annual number of PCI procedures~     undertaken by individual hospitals is predictive of patient mortality post-procedure.~   "
105633|NCT02184728|"~     An end-tidal CO 2 monitor (capnometer) is used most often as a noninvasive substitute for~     PaCO2 in anesthesia, anesthetic recovery and intensive care. There is now also wide-spread~     use of capnometry on-site at emergency and trauma fields. So, portable device can be used~     usefully.~   "
105634|NCT02184715|"~     The purpose of this study is to investigate the effects of virtual reality system on children~     with developmental delays.~   "
105635|NCT02184702|"~     Intubation is needed in general anesthesia and appropriate cuff pressure is important to~     avoid trauma or postoperative sore throat and aspiration. Shoulder arthroscope uses some~     amount of irrigation fluid and it can influence to cuff pressure. Therefore, we will measure~     cuff pressure during shoulder arthroscope.~   "
105617|NCT02184936|"~     Treatment of acute ischemic stroke (AIS) is aimed at salvaging viable but ischemic brain by~     opening the occluded artery and restoring anterograde perfusion as quickly as possible. Time~     saved while making critical decisions correctly is vital in AIS management. Conventional~     angiography is invasive, resource intensive and not feasible as a fast diagnostic tool.~     Perfusion CT and MRI are both susceptible to patient motion, need trained personnel to~     process and take at least 10-30 min to acquire and interpret. The investigators have~     developed a new imaging tool, multi-phase CT Angiography (CTA), which generates multiple time~     resolved images of backfilling arteries beyond a blocked artery filled by collaterals.~      Investigators seek to determine: i) if patients with AIS will have a differential clinical~     response to early recanalization based on collateral status assessed on multi-phase CTA, ii)~     if the extent to which collateral assessment on multi-phase CTA resembles perfusion CT in~     predicting which patients will have good clinical outcome with early recanalization, iii)~     Identify determinants of variability in native collateral status in patients with acute~     ischemic stroke.~      Investigators hypothesize that patients with good and intermediate collaterals on multi-phase~     CTA achieve good clinical outcome with early recanalization (within 4 hours of baseline~     imaging); patients with poor collaterals do not do well even with early recanalization.~      Prove-IT is a prospective multi-center hospital-based cohort study of 500 consecutive~     patients with acute ischemic stroke presenting within 12 hours of stroke symptom onset with~     evidence of intracranial occlusion on routine CTA over 3 years. Calgary and seven other~     comprehensive stroke centers will recruit patients into this study. Primary outcome is~     defined as a National Institute of Health Stroke Scale (NIHSS) score of 0 to 2 at 24 hours or~     an 8-point drop in NIHSS score from baseline to 24 hours. Secondary outcomes are a) 90-day~     modified Rankin Score (mRS) 0-2 or equal to the pre-stroke mRS; b) percent neurologic~     improvement comparing NIHSS at baseline to 24 hours; c) 90-day NIHSS score 0-2; d) infarct~     volume on 24 hour imaging and e) parenchymal intracerebral hemorrhage type 1 and 2 (ECASS II~     criteria) at 24 hrs.~      Prove-IT looks to establish the ideal imaging selection tool for intra-arterial (IA) and~     thrombolysis decisions in the setting of AIS which is widely available, and can quickly and~     reliably detect salvageable brain.~   "
105618|NCT02184923|"~     The long-term goal of this research is to advance our knowledge of how information from the~     labyrinth is brought to perception and how adaptation to vestibular imbalance influences~     spatial orientation. In healthy human subjects verticality perception is accurate while~     upright.The strategy of this research is to quantify changes in verticality perception after~     unilateral lesions along the central graviceptive pathways and to assess the frequency and~     pattern of abnormal verticality perception in patients with acute stroke (ischemic or~     hemorrhagic). Our underlying hypothesis is that screening for erroneous verticality~     perception by use of a mobile device assessing the subjective visual vertical (SVV) during~     the acute phase (i.e., within 24-48 hours after symptom onset) reliably identifies those~     patients with defects. Early detection of deficits in verticality perception may help to~     initiate balance physiotherapy early.~   "
105619|NCT02184910|"~     It is well-known that atrophic gastritis is a major risk factor for gastric cancer, which~     leads to variations in the serum levels of gastrin, pepsinogen (PG) I, and PGII. We want to~     assess the effects of age, sex, and Helicobacter pylori status on pepsinogen (PG) level for~     atrophic gastritis and whether gastric atrophy based on the PG test would be improved after~     H. pylori eradication.~   "
105620|NCT02184897|"~     Twenty four patients with multiple myeloma will be randomized to either AM group~     (administration of lenograstim at 8 am) or PM group (administration of lenograstim at 6 am ).~     Apheresis of hematopoietic stem cell will start at 10 am on D5 in AM group and at 8 am on D4~     in PM group, respectively. Pharmacokinetic data of lenograstim will be correlated with~     pharmacodynamic data of CD34+ cell count, absolute neutrophil cell count and hematopoeitic~     progenitor cell count. In addition, the yield of stem cell collection between two arms will~     be analyzed.~   "
105621|NCT02184884|"~     The whole blood Thrombelastograph (TEG®) Platelet Mapping™ assay measures clot strength,~     maximal amplitude (MA), reflecting maximal platelet function, and detects the reduction in~     platelet function, presented as percentage inhibition, by both aspirin and clopidogrel. A~     study reported that the TEG® can be used as routine monitoring of the variability in ADP~     receptor inhibition and of antiplatelet therapy. Therefore, using TEG Platelet Mapping assay,~     we could find out the perioperative clopidogrel responsiveness of the patients with ACS~     undergoing OPCAB.~      The purpose of this study is to determine whether the rate of the major adverse cardiac~     events (MACE, a combined endpoint of MI, revascularization and cardiac death) is higher in~     the patients with high degree of clopidogrel resistance, who are scheduled to undergo the~     OPCAB due to ACS.~   "
105622|NCT02184871|"~     The aim of the present study is to perform a comprehensive molecular characterization of~     intrahepatic cholangiocarcinoma (ICC) in patients exposed to well-known or putative risk~     factors (such as asbestos) for this malignancy, in order to identify possible molecular~     signatures associated to such different risk factors.~   "
105623|NCT02184858|"~     This open label 4 month study will evaluate efficacy (blood pressure lowering effects) and~     safety of lisinopril in children 1-18y whose parents grant permission to participate. This~     dose titration study is being conducted to support the statement that personalized titration~     of lisinopril (based on blood pressure and renin-aldosterone ratio) can increase patient~     response.~   "
105624|NCT02184845|"~     Multi-centre study evaluating the NobelActive 3.0 mm implant immediately restored with single~     crowns in the maxillary lateral incisor area or mandibular central or lateral incisor area.~   "
105625|NCT02184832|"~     This study will examine the influence of dietary intake of tryptophan on response to~     metformin. The investigators hypothesize that dietary tryptophan alteration will influence~     metformin response.~   "
105626|NCT02184819|"~     The investigators want to test the hypothesis that an infusion of levosimendan started prior~     to CABG surgery can reduce incidence and severity of low cardiac output syndrome in patients~     with poor LV function (EF 40% or less).~   "
105627|NCT02184806|"~     Ovarian tissue cryopreservation is a new technique for female fertility preservation. One way~     to restore fertility is autotransplantation of ovarian tissue.~      The principal purpose of this study will be to evaluate the efficiency and safety of this~     procedure.~   "
105628|NCT02184793|"~     Maintaining mechanically-ventilated patients in semi-recumbent position (defined by a head of~     bed inclination between 30° and 45°) would decrease the risk of pneumopathy occurrence in~     those patients. However, such a bed inclination frame is still difficult to maintain in~     day-to-day care.~      The aim of the study is to evaluate the impact of an electronic monitoring device on the~     proportion of time spent per day in semi-recumbent position, as defined by a head of bed~     inclination between 40° and 50°, in mechanically-ventilated patients.~   "
105636|NCT02184689|"~     The aim of the study is to assess the efficacy and safety of an oral regimen of fexinidazole~     (once daily for 10 days) in the treatment of stage 1 and stage 2 T.b. gambiense sleeping~     sickness in children at least 6 years old and over 20 kg bodyweight.~   "
105640|NCT02184637|"~     This will be a single-centre, 5-cohort, randomized open-label, parallel-group study in~     healthy volunteer subjects. This study aims to provide sufficient pharmacokinetic (PK)~     evidence to support the safe usage of Tafenoquine (TQ) in studies and markets where the~     Artemisinin-based Combination Therapies (ACTs) are the standard of care for patients with~     Plasmodium vivax malaria (i.e., co administration with TQ). The objective of this study is to~     assess the pharmacokinetics, safety and tolerability of TQ when co-administered with the~     chosen ACTs (AL and DHA + PQP), administered concomitantly in healthy subjects. Specifically,~     the study will evaluate whether there are drug-drug interactions between TQ and each of the~     ACTs and if these interactions are considered to be clinically significant. The co-primary~     objectives of this study are to characterize both the effects of a 300 milligram (mg) single~     dose of TQ on the pharmacokinetics; changes in (area under the concentration-time curve from~     0 to time t) AUC (0-t), AUC (0-infinity), and maximum observed concentration (Cmax) of each~     of the two Artemisinin-based Combination Therapies (ACT) according to their prescribed dose~     when co-administered as well as the effects of the ACTs on the PK of TQ.~      A total of 120 subjects (24 subjects in each of 5 cohorts) are planned to be enrolled in~     order to ensure a target sample size of at least 22 subjects completing the study per cohort.~     All subjects will arrive in the unit at least 24 hours prior to dosing and be discharged~     after 72-hour post first dose assessments have been completed. Subjects will return for~     outpatient visits on Days 7, 14, 21, 28, and 56 after first dose.~   "
105641|NCT02184624|"~     This is a randomised, open-label, placebo, crossover, multicentre study with a single visit.~     The study will comprise five sub-studies. Subjects will receive inactive treatment (placebo)~     via the ELLIPTA® inhaler and one of the other inhaler devices depending on the sub-study they~     are randomised to. Only subjects who are naïve to the ELLIPTA inhaler and to one of the other~     inhaler devices that will be used in this study will be included. Furthermore, subjects who~     are naïve to the BREEZEHALER® and HANDIHALER® inhalers must be naïve to all other inhaler~     devices that requires a capsule. The study will be conducted in the UK and the Netherlands,~     and comprises one visit only. A sufficient number of subjects (at least 600) with COPD will~     be screened and 570 will be randomised to one of five sub-studies. Eligible subjects will be~     allocated to one of the sub-studies depending on their experience of using the other inhaler~     (i.e., depending on which other inhaler they are naïve to).~      This study is designed to assess the proportion of COPD subjects making critical and overall~     (i.e., critical and non-critical errors) errors in using ELLIPTA inhaler and other~     commercially available inhaler devices such as the TURBUHALER®, HANDIHALER, BREEZHALER, MDI~     and DISKUS®/ACCUHALER® inhalers. This study will also assess the 'ease of use' and preference~     between the ELLIPTA inhaler and the other commercially available inhaler devices.~      ELLIPTA, DISKUS, and ACCUHALER are registered trademarks of the GSK group of companies.~     TURBUHALER is a registered trademark of AstraZeneca. HANDIHALER is a registered trademark of~     Boehringer Ingelheim Pharma GmbH & Co. KG. BREEZHALER is a registered trademark of Novartis~     AG.~   "
105642|NCT02184611|"~     Studies to date provides substantial evidence for the effectiveness for UMEC 62.5 microgram~     (mcg) as a long term maintenance therapy for the treatment of COPD; this study further~     evaluates the efficacy and safety of UMEC 62.5 mcg administered once-daily (OD) for 24 weeks~     via a NDPI compared with placebo in Asian subjects with COPD. Over approximate 27 weeks of~     entire study duration, 10 study clinic visits will be conducted on an outpatient basis.~     Pre-screening visit will be conducted for the informed consent form, review demography, COPD~     history and COPD concomitant medications. Subjects meeting the eligibility criteria at~     screening will complete a 7 to 14 day Run-in period and will be provided with~     albuterol/salbutamol as rescue medication on an as-needed basis. Further, subjects will be~     randomized to the UMEC 62.5 mcg or matching placebo in a 1:2 ratio for 24 week treatment~     period. A follow up for adverse event assessment will be scheduled approximately 7 days after~     the treatment period or the Early Withdrawal Visit.~   "
105643|NCT02184598|"~     Purpose: This project assess the effectiveness of a cognitive training as an add-on~     intervention to drug treatment in children and adolescents diagnosed with~     Attention-Deficit/Hyperactivity Disorder (ADHD) compared to a placebo training. The cognitive~     training consists of 6 computerized games that are based on principles of neuroplastic~     change.~      ADHD: current treatment - International clinical guidelines indicate that pharmacological~     interventions in particular stimulants are the first-line treatment for ADHD. However, about~     30% of children affected by the disorder do not respond to medication alone, exhibit partial~     response or can not tolerate the adverse effects. In addition there is a group of parents who~     do not accept the use of medication for the treatment of ADHD in their children. In recent~     years cognitive training has received considerable attention as a treatment to ADHD. The~     evidence base for cognitive training programs are still forming with few randomized~     placebo-controlled studies. However, this approach seems to be effective either as a~     treatment for ADHD - and others cognitive disorders in childhood - or as a tool to enhance~     cognitive ability and school performance in children and adults. No previous study has~     evaluated this cognitive intervention in a clinical trial with placebo-controlled~     intervention and as an adjunctive treatment to medication. Additionally, the investigators~     will assess brain changes associated with this intervention using neuroimaging (fMRI).~   "
105644|NCT02184585|"~     This study will be an open-label, randomized, single dose, three way crossover study in~     healthy male subjects. The aim of the study is to evaluate the pharmacokinetic parameters of~     two formulations of a fixed dose combination (FDC) capsule of dutasteride and tamsulosin~     hydrochloride (HCl) (0.5 milligram [mg]/0.2 mg) relative to co-administration of dutasteride~     0.5 mg capsules and tamsulosin hydrochloride 0.2 mg tablets in both the fed and fasted~     states. Approximately 84 healthy adult male subjects will be enrolled into the study and~     split into two cohorts (fed and fasted), allowing for approximately 36 subjects to complete~     each cohort. Subjects from both cohorts will receive single oral doses in 3 treatment periods~     and be randomized to one of six different treatment sequences (ABC, ACB, BAC, BCA, CAB, CBA)~     wherein A= FDC1: Dutasteride and tamsulosin HCl (0.5 mg/0.2 mg), B= FDC2: Dutasteride and~     tamsulosin HCl (0.5 mg/0.2 mg), C= Co-administration of commercial formulations of~     dutasteride(0.5mg) and tamsulosin HCl (0.2mg). Each treatment period will be separated by a~     minimum 28 day washout period. Blood samples for pharmacokinetic analysis will be taken at~     regular intervals after dosing. Safety will be assessed by measurement of blood pressure,~     heart rate and review of adverse events.~   "
105646|NCT02184559|"~     The purpose of the multimodal postoperative analgesia is to improve the quality of analgesia~     and reduce side effects of morphine (nausea, vomiting, sedation, urinary retention,~     respiratory depression ...). In the case of caesarean sections, the quality of analgesia~     allows one hand to improve the mother-child relationship and the quality of breastfeeding,~     the other to reduce the risk of postpartum depression and chronic pain . Two methods of~     administration of local anesthetics have been proven effective for analgesia of the abdominal~     wall under umbilical: The Transversus Abdominal Block Plan (TAP Block) and infiltration of~     the scar continues operating. The TAP block was performed under ultrasound guidance by the~     anesthesiologist after the intervention in a single injection of local anesthetic in the~     abdominal wall and has a period of limited and variable. The infiltration continues catheter~     is placed by the surgeon before closing the wound and allows the infusion of local~     anesthetics for 48 hours.~      The purpose of this study was to compare morphine consumption between both techniques, and~     the quality of analgesia and side effects of morphine~   "
105647|NCT02184546|"~     The purpose of this study is to determine the impact that treatment with a cellular~     concentrate derived from an individual's own fat, known as the stromal vascular fraction~     (SVF), has on the quality of life of people with Parkinson's disease (PD). SVF contains~     components with regenerative properties, including stem cells that may be capable of~     ameliorating specific disease conditions. This study is designed to evaluate quality of life~     changes in individuals with PD for up to 12 months following SVF treatment.~   "
105648|NCT02184533|"~     The purpose of this study is to determine the maximum-tolerated dose (MTD) of sodium selenite~     when administered in combination with radiation therapy to subjects with metastatic cancer~     based on safety and tolerability.~   "
105649|NCT02184520|"~     This postmarket surveillance study is being conducted to evaluate the TRANSITION~     Stabilization System as an adjunct to fusion in the treatment of acute or chronic~     instabilities or deformities of the thoracic, lumbar and sacral spine. The study will involve~     up to 360 subjects at no more than 20 sites, to be treated with the TRANSITION Stabilization~     System. The data from this postmarket surveillance study will be provided to FDA in~     accordance with the 522 order.~   "
105650|NCT02184507|"~     The present study aimed to evaluate the effect of a combination of insulin resistance~     reducing agents pre and post coronary artery bypass grafting surgery on post-operative blood~     glucose and oxidative stress regulation.~   "
105651|NCT02184494|"~     Fatigue is one of the most common and debilitating symptoms experienced in Parkinson's~     Disease (PD) and Multiple Sclerosis (MS). There are multiple proposed mechanisms of~     disorder-related fatigue, however, it is unknown whether PD or MS patients experience~     compromised blood lactate responses to an acute bout of exercise, subjecting them to~     exercise-related fatigue. These populations may experience higher energy expenditure at rest~     due to increased rigidity, however, limited data exists investigating resting energy~     expenditure in these populations.~      Researchers hypothesize that PD and MS patients will display higher resting energy~     expenditure than healthy age-matched controls, and that level of energy expenditure will~     correlate with amount of rigidity or spasticity. Also, we hypothesize that baseline levels of~     lactate will not be different between PD/MS and control groups, but post-exercise blood~     lactate levels will be significantly higher in the PD/MS groups.~   "
105652|NCT02184481|"~     Depression is associated with impairments in executive functions, including working memory~     (WM) which is needed to maintain and manipulate goal-relevant information. Due to these WM~     impairments depressed individuals have difficulties inhibiting and shifting from irrelevant~     (negative) information and updating goal relevant information. This study explored whether~     training WM decreases these impairments and reduces clinical symptoms of depression, anxiety~     and rumination. Sixty-one students with an elevated score on the BDI-II, representing a~     dysphoric mood state, executed a working memory training (n = 34) or placebo training (n =~     27). Before and after training their depression, anxiety, rumination and working memory were~     assessed. Furthermore, they executed a working memory task while their pupil dilation was~     measured to assess their fatigue. Moreover, the investigators compared the dysphoric students~     with a healthy student population on all measures.~   "
105653|NCT02184468|"~     The purpose of this study is to determine if dual dispatch of ambulance, fire fighters and/or~     police in out-of-hospital cardiac arrest (OHCA), can reduce the time to cardiopulmonary~     resuscitation (CPR) and defibrillation, thus increasing survival.~   "
105654|NCT02184455|"~     The purpose of this clinical trial is to perform a limited pilot study to determine the~     safety and feasibility of DermGEN in the treatment of non-healing diabetic foot ulcers (DFU).~     This will be a one-arm prospective study. It is hypothesized that DermGEN treatment will~     result in positive healing outcomes with no significant adverse effects.~   "
105655|NCT02184442|"~     The purpose of this post approval study is to determine the safety, effectiveness and~     learning curve of the SAPIEN™ THV with the Retroflex delivery system for Inoperable Patients~     and with the SAPIEN™ THV with Retroflex and Ascendra delivery systems for high risk operable~     patients with Severe Symptomatic Native Aortic Stenosis via all access sites.~   "
105656|NCT02184429|"~     This study is designed to evaluate the safety and plasma concentrations of PF-06669571 in~     healthy volunteers following single and multiple ascending doses of PF-06669571. Effect of~     food on PF-06669571 plasma concentrations will be be evaluated after a single dose of~     PF-06669571. During multiple dose phase, PF-06669571 will be administered daily for 14 days~   "
105657|NCT02184416|"~     This is an international, multi-centre, prospective (partly retrospective), observational~     study to evaluate treatment patterns and clinical outcomes in patients with advanced or~     metastatic RCC treated with sunitinib in first line and/or receiving axitinib in second line~     post sunitinib. The study is designed to enroll approximately 750 patients over the course of~     an enrollment period of approximately 36 months.~   "
105723|NCT02183558|"~     Women with polycystic ovary syndrome (PCOS) are often insulin resistant. During pregnancy,~     insulin sensitivity decreases. The investigators examine glucose metabolism during oral~     glucose tolerance test and the incidense of gestational diabetes mellitus in a prospective~     cohort of pregnant women with PCOS and controls.~   "
105724|NCT02183545|"~     The objective of this single rising dose study (SRD) is to investigate safety, tolerability,~     and pharmacokinetics of single rising doses of BI 1060469 in healthy Asian male subjects.~   "
105658|NCT02184403|"~     Laryngeal cancer is common in the Taiwanese populations. Before early 80's, open laryngectomy~     was the suggested treatment modality for laryngeal cancer. Patients of laryngectomy lost~     speech and should communicate by using prosthesis. So after 90's, medical organ preservation~     by chemoradiation therapy took the place of operation.~      Unfortunately, from the recent review, five-year survival rate was decreasing and is even~     lower than that reported 10 years ago. In 1983-1985 it was 68.1% but decreased to 64.7% in~     1992-1999. It is the only cancer type of decreasing survival in 24 index cancers.~      Laser resection of laryngeal tumor was first reported by Jako and Strong and widely used in~     the Europe. Dr Steiner and his colleagues developed a non-en block resection technique made~     microscopic resection more easily and would not be limited by tumor location or size so much.~     The investigators used transoral microscopic laser (TLM) in early glottic cancer and reported~     five-year overall survival as 97%. TLM five-year disease control rate was reported as 85%.~     There are some reports about TLM in advanced stage laryngeal cancer and overall 5-year~     survival rate can be achieved as high as 55%. Present project is planning to develop a~     comprehensive organ preservation protocol based on microinvasive TLM as primary treatment~     modality for early glottic cancer without neck or distant metastasis. The objects of the~     project are as followed.~        1. Long term outcomes by performing the treatment protocol. The outcome measurements~          include local control rate, overall and disease specific survival, larynx preservation~          rate.~        2. The difference between surgical samples and pretreatment imaging examination.~        3. The role of adjuvant therapy.~        4. Management and follow-up in neck metastasis.~        5. Searching for risk factors and predictor factors.~        6. Adequate salvage treatments in local or regional recurrence.~        7. Realizing failure patterns and appropriate follow-up protocol according to it.~   "
105659|NCT02184390|"~     This study will evaluate the efficacy and user satisfaction with a web-based interactive~     tutorial for caregivers of young children with autism designed to a) teach parents how to~     promote their child's development in the core deficit areas, b) help parents understand and~     improve challenging behaviors their child may demonstrate, and c) reduce caregiver stress~     through more effective interactions. It emphasizes everyday situations as opportunities for~     learning, including common home routines and contains videotaped illustrations of parents~     using the techniques taught in the home environment.~   "
105660|NCT02184377|"~     Mandarin Chinese phonemically distinguishes four tones, with Tone 1 having high-level pitch,~     Tone 2 high-rising pitch, Tone 3 low-dipping pitch, and Tone 4 high-falling pitch The same~     segmental context carries different meanings depending on the tone. The function deficit of~     cricothyroid (CT) muscle, innervated by external branch superior laryngeal nerve (eSLN),~     would impair the speech tone adjustment. The defect in tone adjustment may interfere with the~     communication function in Mandarin Chinese speaker more than other language users. This may~     explain while peripheral unilateral vocal fold paralysis (UVFP) patients with eSLN injury had~     worse outcomes than those with sole recurrent laryngeal nerve paralysis. The neuromuscular~     control of laryngeal muscle can be evaluated by laryngeal electromyography (LEMG). The~     investigators have utilized a quantified LEMG (denoted Q-LEMG) in their previous research to~     measure the neuromuscular control of thyroarytenoid- lateral cricoarytenoid (TA-LCA) adductor~     complex. However, the task to measure the CT muscle function by Q-LEMG has not been developed~     yet. It is of thus of utmost interest to develop a standardized task to measure the~     neuromuscular function of CT muscle in Mandarin speakers. In Mandarin speaking patients with~     UVFP, the lexical tone influence from CT muscle can be discovered by the technique. The~     investigators also want to measure the lexical tone correction by conventional laryngoplasty~     and its influence in CT muscle activity. The data of lexical tone and its correlation with CT~     contractile activity is important in attempting pitch adjust artificial electrolarynx.~   "
105661|NCT02184364|"~     To investigate, relative to placebo and conjugated oestrogens, the efficacy, safety and~     tolerability of a 12 weeks peroral treatment twice daily with a cimicifuga racemosa extract~     corresponding to 20 mg, 75 mg or 150 mg plant material on menopause-related neurovegetative~     and mental complaints~   "
105662|NCT02184351|"~     The objectives of this study are to compare the efficacy and safety of Roxane's clotrimazole~     troches vs. Mycelex troches in HIV positive patients with oropharyngeal candidiasis, where~     this condition has been diagnosed by clinical examination and confirmed by fungal culture.~   "
105663|NCT02184338|"~     Study to assess safety, tolerability and pharmacokinetics of BIRB 1017 BS in single rising~     oral doses of 5 to 800 mg in a polyethylene glycol 400 (PEG 400) / 26% ethanol solution in~     healthy male subjects~   "
105664|NCT02184325|"~     Study to evaluate the tolerability and safety of Kiddi® Pharmaton Fizz effervescent tablets,~     in children of 6 to 14 years, comparing a given formula with an improved one with reduced~     mineral content (qualitatively equivalent to the first one) and a comparator product.~   "
105665|NCT02184312|"~     Study to determine the pharmacokinetic properties of 200 mg (2 x 100 mg tablets once daily)~     and 300 mg (3 x 100 mg tablets once daily) Nevirapine extended release formulations and to~     estimate relative bioavailability of these formulations as compared to 200 mg VIRAMUNE®~     tablet as well as to 400 mg Nevirapine extended release tablet~   "
105666|NCT02184299|"~     Study to determine the incidence of rash between the group receiving nevirapine without~     prednisone and the group receiving nevirapine with prednisone~   "
105667|NCT02184286|"~     The objectives of this study are to determine the effects of nevirapine on the steady-state~     pharmacokinetics of saquinavir-sgc and to determine the effects of saquinavir-sgc on the~     steady-state pharmacokinetics of nevirapine. This study will also evaluate the~     pharmacokinetics of nevirapine in combination with saquinavir-sgc compared to historical~     controls treated with nevirapine but without saquinavir-sgc.~   "
105668|NCT02184273|"~     Study to assess the analgesic efficacy in the prevention of postoperative pain in children~     undergoing minor surgery (herniorraphy, tonsillectomy) and to assess the tolerability of~     Metamizol in this group of patients.~   "
105669|NCT02184260|"~     Clinical efficacy and safety of Metamizole 2 g i.v. versus placebo, as antithermic therapy in~     the acute phase of ischemic stroke.~   "
105670|NCT02184247|"~     Study to compare the bioavailability of 350 mg Bronchoretard® - a sustained-release~     theophylline (anhydrous) product with respect to the reference product, Theo Dur® 300 mg~     theophylline anhydrous (sustained-release product) by comparing the rate and extent of~     absorption of theophylline based on both single and multiple-dose profiles.~   "
105671|NCT02184234|"~     Main objective: Safety and tolerability of Antistax® film coated tablets~      Secondary objective: Effect of Antistax® film coated tablets on subjective symptoms of~     chronic venous insufficiency~   "
105725|NCT02183532|"~     Study to investigate the pharmacokinetics of BI 1356 after single and multiple oral doses of~     5 mg in Chinese healthy subjects~   "
117218|NCT02033226|"~     The objective of this study is to evaluate the anti-inflammatory and anti-infective~     properties of amniotic membrane (AM) when used for guided tissue regeneration (GTR) in~     periodontal bone defects.~   "
105672|NCT02184221|"~     Transcranial magnetic stimulation (TMS) is an effective alternative for pharmacotherapy in~     major depressive disorder, but the effectiveness is not clear due to stimulated region,~     frequency and intensity of magnet field. Standard TMS techniques only can stimulate~     superficial cortical areas as the electric field decreases rapidly as a function of tissue~     depth，while depression is also interconnected with deeper neuronal regions. Deep-brain~     magnetic stimulation (DSM, or deep TMS, DTMS) allows stimulation of deeper cortical regions.~     Previous research has demonstrated that alpha frequency (8-13 Hz) EEG activity may have~     particular relevance to the response to antidepressants, and reduction of alpha frequency~     (8-13 Hz) could lead to negative symptoms. It has been reported that both alpha frequency and~     low-field magnetic stimulation could improve depressive symptoms.~      The objective of this study is to compare the effectiveness of the two different parameters~     of DMS in the treatment of major depressive disorder. The changes of brain derived~     neurotropic factor (BDNF) are also investigated to make a relevant analysis of the~     improvement of depressive symptoms.~   "
105673|NCT02184208|"~     Today, the electronic medical record, microprocessor mechanical ventilators, and physiologic~     monitoring are under-utilized when translating research into decision support. Current~     medical informatic capabilities can be leveraged to calculate trends in measured parameters~     to initiate a paradigm shift in critical care from reaction-based treatment to proactive and~     plausibly preventative care. Therefore, the purpose of this study is to develop baseline~     understanding of our practice and how data collection utilizing a newly implemented system~     called T3. We would like to retrospectively review mechanically ventilated patients in which~     we have collected continuous data to test a newly developed analytic platform. Additionally~     we would like to compare these results to our standards of practice established by clinical~     practice guidelines.~   "
105674|NCT02184195|"~     A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Maintenance~     Olaparib Monotherapy in Patients with gBRCA Mutated Metastatic Pancreatic Cancer whose~     Disease Has Not Progressed on First Line Platinum Based Chemotherapy~   "
105675|NCT02184182|"~     One of the limiting factors in the execution of a liver resection, in particular an extended~     liver resection, it's represented by the future remnant liver (FRL) after hepatic surgery. In~     cases of normal organ function an FRL of 25% is considered sufficient. In case of impaired~     hepatic function or a history of chemotherapy, it is considered safe if at least of 40%.~      Many strategies have been developed and proposed to increase the resectability in patients~     undergoing major liver resections.~      One of these is a new two-stage technique proposed recently by a group of German surgeons.~     This approach consists in the ligation of the right portal vein associated with resection of~     the liver along the falciform ligament (step 1). Step 2, after a period of 9 days (median -~     5-25 days), after a volumetric CT to ensure an adeguate hypertrophy of the left lateral lobe~     due to the combination of right portal occlusion and segment 4 devascularization, the patient~     undergo a right trisectionectomy. The hypertrophy of the left lateral lobe is shown to be of~     74%, higher than any other techniques of ligation or portal embolizatiol proposed in the~     literature.~      On the basis of the clinical experiences reported the investigators designed a new protocol~     of two-stage hepatic resection for the treatment of primary or secondary tumors of the right~     lobe. Step1: laparoscopic radio frequency / microwave ablation of the future transection~     plane between segment 4 and left lateral lobe and surgical ligation or embolization of the~     right portal vein. The ablation has the purpose to devascularize the segment 4 and has the~     same significance of the resection of the liver along the falciform ligament described by the~     Regensburg group.~      Step2: After a period of time of 9 ± 2 days, following a volumetric CT showing an adequate~     liver volume gain (ratio FRL / patient body weight> 0.5), the patient undergo the~     second-stage surgery: laparoscopic/ laparotomic right trisectionectomy.~   "
105676|NCT02184169|"~     The purpose of the Oxy-CAHN study is to improve the monitoring capabilities of newborn~     infants recovering from congenital heart surgery. Currently, we utilize important but~     unsophisticated measures, such as vital signs and lactate measurements, to monitor these~     patients. Although they are useful in categorizing patients as well or unwell, these signs~     currently lack the power quantify a patient's risk for cardiac arrest. More to the point,~     they are mostly indirect measures of what we really are assessing, which is tissue oxygen~     delivery.~      Our group has signiﬁcant expertise with devices which quantify the amount of oxygen that a~     baby consumes every minute. Historically, these values are more commonly used in combination~     with other measures to assess nutritional and metabolism status. In critically ill patients,~     however, the volume of oxygen consumed by a patient may be limited by the amount of oxygen~     their circulation delivers. This may represent a critical relationship, which has been~     previously described, but not exploited for the purpose of identifying patients with~     critically low oxygen delivery.~      The aims of this study are therefore (1) to demonstrate that oxygen consumption can be safely~     and precisely measured continuously in newborns undergoing one of two common congenital heart~     surgeries, (2) to determine whether postoperative circulatory failure is associated with a~     precedent change in oxygen consumption, and (3) to determine whether the addition of the~     oxygen-based measurements (including oxygen consumption and venous oxygen saturations) to~     standardly measured parameters will add power in predicting which patients will experience~     postoperative circulatory failure.~      If successful, this study may improve our capacity to non-invasively and continuously monitor~     patients following the highest risk congenital heart surgeries, and in the future,to create~     an algorithm which quantiﬁes a patients risk for having a cardiac arrest. This may permit~     providers to intervene on these patients earlier, improving the morbidity and mortality~     associated with congenital heart disease.~   "
105677|NCT02184156|"~     In this Phase I/Phase II clinical trial, 7 eligible patients with OA of the knee will receive~     Ampion™ 4 mL administered as three IA injections, 2 weeks apart. In the absence of serious~     drug-related AEs of unanticipated drug-related AEs, enrollment will be initiated in Phase II~     of the study.~      In Phase II, a total of 30 eligible patients with OA knee pain will be randomized 1:1 to~     receive either the active drug (Ampion™ 4 mL) or placebo as three IA injections, 2 weeks~     apart.~   "
105678|NCT02184143|"~     The overall objective of this study is to conduct a two-group randomized control trial (RCT)~     to compare which of two treatments provided by telephone - a cognitive-behavioral based~     physical therapy (CBPT) program focusing on self-management strategies or an education~     program about postoperative recovery - are more effective for improving patient-centered~     outcomes in older adults recovering from lumbar spine surgery for degenerative conditions.~     Our central hypothesis is that the CBPT intervention focusing on self-management will~     decrease pain and disability and improve general health, physical activity and physical~     function in community-dwelling adults undergoing spine surgery, through reductions in fear of~     movement and increases in pain self-efficacy.~   "
105726|NCT02183519|"~     The purpose of this research study is to test cough function in individuals with Parkinson's~     disease and healthy older adults. Cough is a complex, defensive function which involves~     movement of the chest and lungs. The investigators want to compare the movement of the chest~     wall and the lungs during voluntary and reflex cough.~      The long-term goal of this research is to develop treatments for people with cough~     dysfunction. Cough dysfunction increases the risk for respiratory infections such as~     pneumonia. The results from this study will provide information to help researchers~     understand the difference between reflex and voluntary cough more fully.~   "
105727|NCT02183506|"~     Investigate the bioavailability of BI 1356 BS and of metformin after concomitant multiple~     oral administration of 10 mg BI 1356 BS tablets and 3 x 850 mg metformin in comparison to BI~     1356 BS and metformin given alone~   "
105728|NCT02183493|"~     To investigate the food effect on the relative bioavailability and pharmacokinetics of a 5 mg~     BI 1356 tablet administered as a single dose~   "
105679|NCT02184130|"~     The long-term goal of this research is to advance our knowledge of how information from the~     labyrinth is brought to perception and how adaptation to vestibular imbalance influences~     motion sensation. Patients with vestibular disorders frequently have disabling disturbances~     of perception. Related to these symptoms is that large areas of the cerebral hemispheres and~     the cerebellum receive information from the vestibular, visual and somatosensory systems that~     is integrated within a vestibular cortical network into an accurate perception of spatial~     orientation. Interrupting the pathways that process information about the direction of~     gravity and angular velocity leads to impairment of the internal estimate of gravity and the~     perception of body motion. The strategy of this research is to use repetitive transcranial~     magnetic stimulation (rTMS) to produce transient focal lesions that allow study of acute loss~     of function within the central vestibular pathways at the very beginning of adaptation. Our~     underlying hypothesis is that the immediate effects of a lesion in the cerebellum will be to~     affect ocular motor control of vestibular reflexes and perception alike but with a cortical~     lesion there will be dissociation between ocular motor control and perception. This research~     helps to understand the mechanisms involved in the perception of vestibular information and~     the cerebellar influence on processing vestibular input and offers a unique opportunity to~     make major inroads into the understanding and eventually treatment of the often~     incapacitating symptoms of patients with vestibular disease~   "
105680|NCT02184117|"~     The purpose of this study is to determine the diagnostic performances of iodine contrast~     medium and resting conditions to predict fractional flow reserve (FFR). Reference FFR will be~     measured using standard adenosine. We hypothesize that contrast FFR will offer superior~     diagnostic agreement compared to resting conditions.~   "
105681|NCT02184104|"~     The purpose of this study is to determine how fast caffeine gets into your body with a~     product called Aeroshot™. Aeroshot™ is a lipstick sized device that you slide open and then~     put your mouth over the opening and inhale. A fine powder containing 100 mg of caffeine is~     deposited on your tongue and the inside of your mouth. Caffeine will be absorbed through the~     membranes in your mouth or swallowed and then absorbed in your stomach. We will compare the~     absorption of caffeine after using the Aeroshot™ with the absorption after drinking an energy~     drink by taking 15 blood samples over 8 hours and measuring the caffeine levels in your~     blood. You will also be asked to fill out some scales to measure the effects you feel after~     the caffeine dose. We hypothesize that caffeine absorption after inhalation will be faster~     than after an energy drink.~   "
105682|NCT02184091|"~     Study to assess the effects of varying degrees of renal dysfunction and hepatic insufficiency~     on the single-dose pharmacokinetics of nevirapine and nevirapine metabolites in order to~     establish an appropriate dose and/or dosing frequency for renally- and hepatically-impaired~     patients~   "
105683|NCT02184078|"~     Study to determine the effects of nevirapine on the steady state pharmacokinetics of~     rifabutin and to assess the steady state pharmacokinetics of nevirapine when given in~     combination with rifabutin~   "
105684|NCT02184065|"~     Observational study to evaluate the efficacy and safety of meloxicam (Mobicox®) in Mexican~     population with rheumatic diseases~   "
105685|NCT02184052|"~     Study to determine the safety and efficacy of Mobic® ampoules in the initiation of treatment~     of painful exacerbations of osteoarthritis, rheumatoid arthritis and other similar painful~     inflammatory conditions.~   "
105686|NCT02184039|"~     Study to evaluate the efficacy and safety of meloxicam (Mobicox®) in Mexican population with~     rheumatic diseases.~   "
105687|NCT02184026|"~     The study implements a trauma-related nightmare treatment for children aged 8 to 13 years.~     Relevant outcome progress and outcome measures on symptoms, nightmare distress and duration,~     academic indicators, and sleep quality will be examined.~   "
105688|NCT02184013|"~     This is a pilot study to assess the usefulness of ECG mapping, and enhanced MRI and PET scan~     imaging in identifying atrial fibrosis and arrhythmia circuits involved in persistent atrial~     fibrillation and in guiding an innovative AF catheter ablation strategy.~      It is hypothesized that identifying these critical arrhythmia circuits and atrial fibrosis~     with enhanced imaging and performing an individualized innovative AF catheter ablation will~     result in higher procedural success rates.~   "
105689|NCT02184000|"~     AIM: To evaluate the role of Strain Elastography in the assessment of liver fibrosis in~     chronic hepatopathy~   "
105690|NCT02183987|"~     Chronic kidney disease (CKD) and its end stage of kidney failure requiring dialysis are~     important contributors to morbidity, mortality and health care costs. Over the last two~     decades, there has been a strong secular trend in the earlier initiation of dialysis for~     treatment of kidney failure from progressive CKD. These trends have occurred in spite of~     evidence showing harms with early dialysis initiation and increased health care costs.~     Recently, investigators from the Canadian Society of Nephrology, including study~     co-investigators, have proposed clinical practice guidelines to recommend an~     intent-to-defer approach for dialysis initiation. Whether these guidelines require an~     active knowledge translation strategy or they will simply translate through passive~     dissemination is unknown.~      In the investigators' proposed national cluster parallel group randomized clinical trial, we~     will randomize CKD clinics across Canada to an active knowledge translation strategy to defer~     dialysis initiation or passive dissemination of guidelines (current practice). The unit of~     observation will be the patient (i.e., outcomes will be measured at the level of an~     individual patient), and the unit of randomization will be at the level of the~     multidisciplinary CKD clinic. The investigators will then evaluate the kidney function~     (estimated glomerular filtration rate - eGFR) at dialysis initiation for all dialysis starts~     originating from these clinics to examine whether our KT strategy is safe and effective at~     delaying dialysis initiation. Our active KT strategy, if effective, will have a significant~     impact on patient morbidity and health care costs.~      The investigators' hypothesis and specific aims are as follows:~      Hypothesis: The investigators hypothesize that the clinics randomized to the active KT~     strategy will start a greater proportion of patients on dialysis later (eGFR below 10.5~     ml/min/1.73m2) compared to the control.~      Aim 1 - Efficacy: To compare the impact of an active KT intervention with passive guideline~     release on the proportion of patients followed by a Nephrologist ( > 3 months) who start~     dialysis with an eGFR >10.5ml/min/1.73 m2 across the randomized CKD clinics (clusters) in~     Canada.~      Aim 2 - Safety: To compare the impact of an active KT intervention with passive guideline~     release on safe dialysis initiation (acute unplanned dialysis starts) across the randomized~     CKD clinics in Canada.~   "
105691|NCT02183974|"~     The aim of the study was detection of pepsin in effusion in children with OME using Peptest~     as new quick and cheap method of detection and comparison results with results of other~     studies in which pepsin was detected by more demanding methods. Such a type of study hasn't~     been done so far.~   "
105692|NCT02183961|"~     Detection of extraesophageal reflux (EER) in children with chronic otitis media with effusion~     (OME) using three different diagnostic methods and selection of the group of patients with~     severe EER who could potentially benefit from antireflux therapy.~   "
105693|NCT02183948|"~     The purpose is to test whether oxytocin has an effect on masked facial expressions~   "
105729|NCT02183480|"~     Study to assess the pharmacokinetics and dose proportionality of 1 mg, 2.5 mg and 5 mg~     tablets of linagliptin~   "
105694|NCT02183935|"~     Obesity and its complications have a significant effect on morbidity and mortality in these~     subjects. Especially at risk are subjects with extremely increased BMI (above 99th percentile~     for age and gender in adolescents). In these subjects classical treatment with diet and~     cognitive therapy has a limited effect. Bariatric procedures, at the moment, are the only~     feasible therapeutic possibility.~      Bariatric procedures are based on several principles; restrictive, malabsorptive and~     combined. They can be surgical or endoscopic. The later are used in subjects that do not~     qualify for surgical procedures that decline them or are used before a planed definite~     bariatric procedure.~      Duodena-jejunal liner (DJL) is an endoscopic tool, that is efficiently and safely used to~     decrease body weight and ameliorated obesity complications, especially those associated with~     diabetic state.~      Aims of the study are:~        -  To determine (short and long-term) efficacy of DJL in decreasing body weight in~          adolescents.~        -  To determine (short and long-term) efficacy of DJL in ameliorating complications of~          morbid obesity - abnormal glucose metabolism, dislipidemia, altered adipokine secretion~          pattern, altered secretion pattern of gastrointestinal hormones in adolescents.~        -  To visualize functional alternations in the selected central nervous system regions~          associated with appetite regulation upon insertion of DJL.~   "
105695|NCT02183922|"~     Our aim was to assess the effects of a hypocaloric diet, including diet fruit jelly with~     microencapsulated fish oil or conjugated linoleic acid or placebo, on anthropometry, body~     composition, insulin resistance and lipid profile in women with metabolic syndrome and~     genotype Pro12Pro in the PPAR gamma 2 gene.~   "
105696|NCT02183909|"~     The overall goal of the CRUSH project is to enhance and extend a response to the local~     HIV/AIDS epidemic in Alameda County with a set of innovative, evidence-based interventions~     across the continuum of HIV prevention and care, targeting individuals and communities most~     vulnerable to HIV. The East Bay AIDS Center, in partnership with the University of California~     San Francisco's Center for AIDS Prevention Studies, the Gladstone Institutes, and several key~     community-based organizations, are engaging in a participatory partnership to enhance and~     implement HIV services which target the East Bay's highest risk population- young men who~     have sex with men (Y/MSM). Specifically, the CRUSH Project is designed to evaluate a~     combination of program approaches to address the sexual health care needs of young gay men of~     color and their sexual partners by enhancing the current program activities of the Downtown~     Youth Clinic (DYC).~      We hypothesize that we can reduce the impact of HIV among Y/MSM by expanding the current DYC~     services structure in two ways. We intend to expand HIV testing, and linkage to and retention~     in care for youth who test HIV positive, providing them with intensive risk-reduction~     counseling and antiretroviral treatment, and thereby ultimately reducing the risk of further~     HIV transmission. And we intend for the first time to offer a comprehensive combination~     package of preventive services to HIV-negative youth, including routine accesses to HIV/STI~     screening and treatment, and access to HIV pre-exposure prophylaxis (PrEP).~      The CRUSH Project will also have a substudy that will enroll HIV-negative participants who~     are eligible to receive PEP. The substudy will evaluate the tolerability and acceptability of~     a 28 day course of Stribild® given as post-exposure prophylaxis (PEP) to prevent sexual~     acquisition of HIV-1 in Y/MSM of color.~   "
105697|NCT02183896|"~     The purpose of this research project is to assess the effectiveness of intra-articular~     injections of autologous platelet-rich plasma (PRP) after arthroscopic microfracture. Our~     hypothesis is that platelet-rich plasma will improve patient's clinical outcomes and chondral~     healing following microfracture performed during femoroacetabular impingement (FAI) hip~     arthroscopy.~   "
105698|NCT02183883|"~     To assess if targeting activating EGFR and HER2 mutations in Non-Small Cell Lung Cancer~     (NSCLC) is more effective when these mutations are truncal dominant mutations (≥50%), as~     opposed to non-dominant (≥5 to <50%) or low frequency mutations (<5%).~      This trial will only be available to patients registered to the TRACERx study (NCT01888601).~   "
105699|NCT02183870|"~     EUCROSS is a phase II trial to evaluate the efficacy and safety of crizotinib in patients~     with adenocarcinoma of the lung harbouring ROS1 translocations. Patients will be treated with~     250mg crizotinib bid until progression or intolerable toxicity.~   "
105700|NCT02183857|"~     The use of ultrasound guidance by senior residents learning the technique of femoral artery~     catheterization is superior to the landmark technique.~   "
105701|NCT02183844|"~     It is important that individuals with serious mental illness make informed choices among~     alternative healthcare treatments based on their preferences. However, at present,~     individuals' preferences are often not being elicited, nor used to guide which treatments are~     made available. In this pilot project, the investigators implement and evaluate a~     computerized method for assessing treatment preferences of individuals with schizophrenia.~     The investigators use weight management treatments for this initial test of the system. If~     this assessment method is found to predict treatment use and satisfaction, it can be used to~     guide implementation of treatments that improve outcomes while meeting individuals'~     preferences.~   "
105702|NCT02183831|"~     This study was set up to identify clinical outcomes including a refractive shift or change in~     IOL calculation accuracy and optical quality after Ophtec® capsular tension ring in the eyes~     without zonular instability.~   "
105703|NCT02183818|"~     We aim to use an integrated network systems approach to analyze certain existing small airway~     epithelium (SAE) omic data sets at the genetic, epigenetic (methylation), gene expression,~     microRNA and metabolomic levels, to develop an initial model of network connectivities and~     key network pressure points relevant to SAE biology in health and disease.~   "
105704|NCT02183805|"~     Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop~     growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow~     the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.~   "
105730|NCT02183467|"~     Assessment of the effect of BI 1356 or Placebo on prolongation of the QT interval~   "
105731|NCT02183454|"~     To collect post marketing surveillance data on patients receiving at least one Combo~     Bio-Engineered Sirolimus Eluting Stent when used according to the Instructions for Use. Data~     will be collected in order to assess the long term safety and performance of the Combo Stent~     in routine clinical practice.~   "
105732|NCT02183441|"~     Study to investigate the effect of the P-gp and cytochrome P450 (CYP) 3A4 inhibitor ritonavir~     on the pharmacokinetics of BI 1356~   "
105761|NCT02183064|"~     Study to compare the percentage of treatment successes or failures in patients randomized to~     meloxicam 7.5 mg vs. usual care prescription NSAIDs. Additionally, health care utilization,~     efficacy and safety of patients in a managed healthcare setting with osteoarthritis (OA) of~     the hip, knee, hand or spine will be assessed.~   "
117219|NCT02033213|"~     An exploratory single-centre randomized clinical trial was performed in order to investigate~     whether the fluid volume administered during esophageal carcinoma surgery affects pulmonary~     gas exchange and tissue perfusion.~   "
105705|NCT02183792|"~     Hyponatremia is a common finding in acute heart failure (HF) patients and is associated with~     worse prognosis. In addition to its prognostic value, hyponatremia may have importance during~     the acute management of HF. We've recently shown that acute or chronic hyponatremia,~     especially <130 mEq/L, was associated with higher loop diuretic dose requirements and more~     frequent need for escalation of the diuretic regimen to achieve the same level of diuresis as~     normonatremic HF patients. Aquaresis with tolvaptan represents a potentially advantageous~     approach to the management of volume overload in HF, especially in patients presenting with~     concomitant hyponatremia. The purpose of the current study is to prospectively evaluate the~     comparative efficacy and safety of a tolvaptan-based diuretic regimen compared to~     conventional diuresis with a furosemide-based regimen on short-term clinical and treatment~     outcomes in hyponatremic acute HF patients.~      This will be a prospective, open-label, parallel-group, randomized study comparing a~     tolvaptan-based aquaretic regimen to a conventional continuous infusion loop diuretic-based~     regimen of furosemide. Up to 55 (target sample size of 50) adult subjects admitted with acute~     HF and signs of volume overload, and serum sodium less than 135 mEq/L will be randomized to~     tolvaptan or furosemide treatment arms. The initial 24 hours of study treatment will compare~     tolvaptan monotherapy to furosemide monotherapy. After the initial 24 hours, treatment~     regimens may be altered to achieve desired clinical goals. Patients will be followed for up~     to 96 hours and at discharge for study purposes.~   "
105706|NCT02183779|"~     The main objective of the study is to determine if implication of epoxy-eicosatriénoïc acids~     (EETs) and NO during cutaneous post-occlusive hyperemia differs between patients with Raynaud~     phenomena and healthy volunteers, by studying hyperaemic postocclusive response after~     microinjection of fluconazole and L-NMMA at the dorsal side of the fingers.~   "
105707|NCT02183766|"~     Some prebiotics are useful for improving symptoms related to constipation, but clinical~     trials including infants and older children are scarce. A double-blind, placebo-controlled,~     crossover clinical trial was conducted to evaluate the effect of galactooligosaccharides~     (GOS) on functional constipation in children and adolescents. Twenty children aged 4 to 16~     years of age, who spontaneously sought medical care at a primary healthcare unit, received~     1.7g GOS or placebo (Maltodextrin) treatment for 30 days, followed by a 15-day washout period~     and a 30-day use of an alternative product. A clinical score was calculated at baseline, at~     the 15th (D15) and 30th (D30) day of each period, to assess bowel movement frequency,~     straining/ pain during defecation and stool consistency. Oral anal transit time with~     activated charcoal was determined at baseline and D30 of each period.~   "
105708|NCT02183753|"~     This study is focused on the pathophysiology underlying the association between exposure to~     particulate pollutants and risk for/response to viral infection. The investigators~     hypothesize that exposure to wood smoke particles (WSP) enhances influenza virus-induced~     granulocyte and NK cell activation, via hyaluronic acid-mediated effects on IFNg production.~     Oxidant stress and viral replication may also be affected. As an NIH funded ViCTER project,~     the purpose of the study is also to test novel assays of granulocyte activation (Doershuk~     lab) and lipid mediator activation (Albritton lab) which have not previously been used in~     this type of research.~      Healthy, nonsmoking adults age 18-40 years will be recruited. This is a randomized, placebo~     controlled study comparing NLF granulocyte responses to LAIV administered after either WSP or~     clean air, in normal healthy volunteers. Subjects receive either WSP or placebo (clean air),~     followed by a standardized dose of LAIV and serial post-infection sampling of nasal lavage~     fluids, nasal biopsy and blood~   "
105709|NCT02183740|"~     Fecal incontinence (FI) has an increasing prevalence in the geriatric population which cannot~     be explained by co-morbidity or anatomical and psychological changes of aging alone. In the~     nursing home population previous studies suggest a prevalence between 10 and 69%, but is most~     often reported to be between 40 and 55%. FI leads to a high direct and indirect economic~     burden to the health-care system, and is an important cause og institutionalization of the~     elderly patients. In addition, FI is associated with shame, social isolation and reduced~     quality of life.~      The importance of identifying treatable causes of FI in the frail elderly, rather than just~     managing passively, is strongly emphasized. It is indicated that the level of awareness among~     health personnel regarding appropriate assessment and treatment options is limited, and that~     FI is considered a normal part of aging.~      This study is based on the assumption that FI among nursing home patients can be prevented,~     cured or ameliorated by offering nursing home staff knowledge of best practise. The primary~     objective of the study is to test the hypothesis that a multifaceted educational program for~     staff on assessment and treatment of FI, is associated with a reduction in patients'~     frequency of FI.~      The design of the study is a two armed cluster randomized trail (C-RCT) with a repeated~     cross-sectional approach.The results will be analysed according to multilevel and~     longitudinal modelling, and the study will use mixed effect models with the cluster treated~     as a random effect.~   "
105710|NCT02183727|"~     The purpose of this study is to compare safety and efficacy outcomes of the L-C Ligament~     versus Hamstring Autograft for treatment of acute rupture of the ACL.~   "
105711|NCT02183714|"~     To evaluate the effect of Songha Night ® on insomnia, anxiety and quality of life compared to~     placebo in patients with mild to moderate insomnia.~   "
105712|NCT02183701|"~     The general aim and clinical objective of this trial is to determine the effect of~     telmisartan 80 mg compared to losartan 50 mg + HCTZ (Hydrochlorothiazide) 12.5 mg on~     reduction of blood pressure (BP) in patients with mild to moderate hypertension as assessed~     by 24 hour Ambulatory Blood Pressure Monitoring (ABPM) and trough sitting BP cuff~     measurements at the end of the treatment.~   "
105713|NCT02183688|"~     To confirm the combination rationale for the combination of ASA + paracetamol + caffeine~     compared with the combination of ASA + paracetamol and the individual substances ASA,~     paracetamol, caffeine, and placebo administered orally to headache patients for two headache~     episodes~   "
105714|NCT02183675|"~     To assess drug drug interaction through pharmacokinetics investigation at steady state of~     Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ) given as three different formulations~     in healthy Japanese male subjects~   "
105715|NCT02183662|"~     To investigate safety and pharmacokinetics of BI 224436 ZW~   "
105756|NCT02183129|"~     To assess the efficacy and safety of meloxicam 7.5mg once daily compared with diclofenac~     100mg SR once daily over a treatment period of 8 weeks~   "
105733|NCT02183428|"~     The objective of this study was to investigate the effect of multiple doses BI 1356 given~     once daily in the estimated highest therapeutic dose of 5 mg until steady state on the~     pharmacokinetics, safety, and tolerability of a single oral conventional therapeutic dose of~     1.75 mg glyburide. In addition, the effect of glyburide as a single oral dose of 1.75 mg~     being a conventional therapeutic dose on the multiple dose pharmacokinetics of BI 1356 was~     investigated. Pharmacokinetic profiles of glyburide were determined when given alone or in~     combination with BI 1356. Pharmacokinetic profiles of BI 1356 and its inactive metabolite CD~     1750 were determined at steady state of BI 1356 when given alone or in combination with~     glyburide.~   "
105734|NCT02183415|"~     Study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI~     1356 BS during 4 week treatment duration~   "
105735|NCT02183402|"~     The purpose of this study is to investigate the pharmacokinetics, safety and tolerability of~     digoxin with and without co-administration of BI 1356. Additionally the steady state~     pharmacokinetics of BI 1356 when co-administered with digoxin will be determined.~   "
105736|NCT02183389|"~     To investigate whether and to what extent BI 1356 affects pharmacokinetic and pharmacodynamic~     parameters of warfarin~   "
105737|NCT02183376|"~     To investigate the influence of mild, moderate, and severe liver impairment on the~     pharmacokinetics and pharmacodynamics of linagliptin in comparison with a control group with~     normal hepatic function after single or multiple oral administration of 5 mg linagliptin~     tablets~   "
105738|NCT02183363|"~     Study to investigate the relative bioavailability of 5 mg BI 1356 as tablet formulations~     (Trial formulation) TF II and Intended final formulation (iFF) vs. 5 mg BI 1356 as tablet TF~     IIb~   "
105739|NCT02183350|"~     The primary objective of the current study was to investigate the safety and tolerability of~     BI 1356 BS following administration of multiple rising oral doses of 1 mg, 2.5 mg, 5 mg, and~     10 mg over 12 days in male patients with type 2 diabetes.~   "
105740|NCT02183337|"~     Study to investigate the bioavailability of BI 1356 with and without co-administration of~     pioglitazone and the bioavailability of pioglitazone with and without coadministration of BI~     1356~   "
105741|NCT02183324|"~     Study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 1356~     BS (0.5 mg, 2.5 mg, and 10 mg) administered orally once daily for 28 days in Japanese~     patients with type 2 diabetes mellitus.~   "
105742|NCT02183311|"~     Study to examine the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 1356~     BS administered to healthy male volunteers at single rising oral doses (1 mg, 2.5 mg, 5 mg,~     and 10 mg) and at multiple rising oral doses (2.5 mg, 5 mg, and 10 mg once daily for 12 days)~   "
105743|NCT02183298|"~     Study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of BI~     1356 as formulation for intravenous administration~   "
105744|NCT02183285|"~     To determine the tolerability and safety of Pharmaton PHL 00747 soft gelatine capsules and~     film-coated tablets~   "
105745|NCT02183272|"~     The objective of the current program of research will be to test whether intranasal ketamine~     treatment is more effective than placebo in reducing suicidal ideation in suicidal patients~     presenting for acute treatment in emergency department settings. Secondary objectives will~     test the effect of genotypic differences in the mu opioid receptor on efficacy of ketamine~     and the correlation of speech patterns and facial movement patterns with subjective~     reductions in suicidal ideation after ketamine treatment.~   "
105746|NCT02183259|"~     To investigate the bioavailability of ESR 1150 CL by the time course determination of plasma~     concentration (pharmacokinetics) of no-transformed ESR 1150 after single administration to~     healthy adult male volunteers. Secondary objective is to investigate the safety of ESR 1150~     CL.~   "
105747|NCT02183246|"~     Determination of efficacy and safety of porfiromycin versus placebo as an adjuvant to~     radiotherapy in postoperative head and neck a cancer patients as well as assessment of~     population pharmacokinetic parameters.~   "
105748|NCT02183233|"~     The aim of this trial was to assess the efficacy and safety of Eschscholtzia Californica (EC)~     in treating patients having psycho-physiologic insomnia in a double-blind randomised placebo~     controlled trial during a 28-day treatment duration.~   "
105749|NCT02183220|"~     The objective of the study was to evaluate the efficacy, safety and tolerability of a single~     peroral dose of 0.5 g and 1.0 g metamizol relative to placebo and 1.0 g acetylsalicylic acid~     in 2 episodes of moderate tension headache.~   "
105750|NCT02183207|"~     Percutaneous endoscopic gastrostomy(PEG) by introducer method has been proven to be safe and~     easy to perform. However, it is limited by its need to be performed in an endoscopy unit.~     E.G. ScanTM is an new portable ultrathin endoscope, capable of being performed in any~     hospital setting and introduced via nasal approach. Our aim is to prove that PEG by~     introducer method via E.G. ScanTM is feasible and safe. This will allow PEG to be done at~     hospitals and medical facilities without endoscopic units.~   "
105751|NCT02183194|"~     The purpose of this study is to evaluate the Lutonix® 035 Drug Coated Balloon PTA Catheter~     (CE mark) for use as intended in the treatment of subjects with clinically significant~     hemodialysis vascular access stenosis or occlusion.~   "
105752|NCT02183181|"~     Primary Objective:~      To access the bioequivalence of meloxicam capsule 15 mg (Test, T) to meloxicam tablet 15mg~     (Reference, R) following oral administration.~      Secondary Objective:~      To investigate the safety and tolerability of meloxicam following a single dose of meloxicam~     capsule 15 mg vs. meloxicam tablet 15 mg under fasting conditions in healthy male Taiwanese~     subjects.~   "
105753|NCT02183168|"~     Study to assess the efficacy and safety of meloxicam suppository 15 mg once daily, meloxicam~     tablet 15 mg once daily compared with Indomethacin suppository (50 mg daily) in patients with~     ankylosing spondylitis~   "
105754|NCT02183155|"~     The primary purpose of this study was to evaluate the effect of meloxicam tablets (7.5, 15 mg~     and 30 mg) with meloxicam placebo. Extended-release indomethacin capsules (75 mg) was an~     active control to assess trial sensitivity on bleeding time in healthy subjects. The~     secondary aim of this study was to assess effects of treatment on other platelet function and~     coagulation parameters.~   "
105755|NCT02183142|"~     The objective of this study is to compare the pharmacokinetic parameters of the 7.5 mg Mobic~     tablet manufactured in china in comparison with 7.5 mg tablets manufactured in Germany~   "
105762|NCT02183051|"~     To assess the analgesic efficacy and tolerability of meloxicam 15 mg, 7.5 mg, 3.75 mg and~     1.875 mg oral (rapid release tablet) compared with placebo and ibuprofen 400 mg and 200 mg~     administered in a single dose, over an observation period of 6 hours in the treatment of pain~     after surgery of the third molar.~   "
105763|NCT02183038|"~     Study to assess the efficacy and tolerability of Meloxicam once daily dose of 7.5 mg and 15~     mg compared with 1100 mg of naproxen sodium in the symptomatic treatment of acute non~     bacterial pharyngitis or pharyngo-tonsillitis, over a period of 5 days.~   "
105764|NCT02183025|"~     To access the efficacy and safety of Meloxicam 7.5 mg and 15 mg once daily compared with~     Mefenamic acid 500 mg t.i.d. over a treatment period of 3-5 days, during an observation~     period of 3 menstrual cycles, for the symptomatic relief of primary dysmenorrhea~   "
105765|NCT02183012|"~     -  Study to demonstrate average bioequivalence between a 400 mg ibuprofen extrudate tablet~          (Test) and a 400 mg ibuprofen lysinate tablet (Dolormin extra ®; reference 1) under~          fasted conditions.~        -  Study to determine the relative bioavailability of ibuprofen following single~          administration of a 400 mg ibuprofen extrudate tablet (Test) compared to a 400 mg~          ibuprofen tablet (Brufen® 400mg, Denmark; Reference 2) under fasted conditions.~        -  Study to determine the relative bioavailability of ibuprofen following single~          administration of a 400 mg ibuprofen extrudate tablet (Test) compared to a 400 mg~          ibuprofen lysinate tablet (Dolormin extra ®; reference 1) or a 400 mg ibuprofen tablet~          (Brufen® 400mg, Denmark; Reference 2), respectively, under fed conditions.~        -  Study to evaluate the effect of food on the pharmacokinetics of ibuprofen for all three~          formulations.~   "
105766|NCT02182999|"~     The aim of this study is to investigate the effect of continuous wound infiltration with~     ropivacaine in comparison to standard pain management after elective distal metatarsal~     osteotomy for postoperative pain control.~   "
105767|NCT02182986|"~     Solid organ transplantation is an important therapeutic option for children with a variety of~     end stage diseases. However, the same immunosuppressive medications that are required to~     prevent the child's immune system from attacking and rejecting the transplanted organ can~     predispose these individuals to developing a very serious cancer that is linked to~     Epstein-Barr virus (EBV).~   "
105768|NCT02182973|"~     This study is designed to develop pilot data on the acceptability and benefit of donor human~     milk for infants undergoing pharmacologic treatment for NAS. Specifically, gastrointestinal~     (GI) sub-scores, as well as total scores, will be compared between infants historically fed~     formula and those enrolled in a 2-week donor human milk study period.~      Purpose of study: to test the following null hypothesis:~      Infants with a diagnosis of neonatal abstinence syndrome (NAS) due to in-utero exposure to~     opiates, fed donor human milk, will have similar GI/feeding sub-scores of the Finnegan~     scoring tool when compared to (historic) infants fed formula.~      A rejection of the null hypothesis will be used to design a randomized trial of donor human~     milk in infants with NAS.~   "
105769|NCT02182960|"~     Pharmacokinetics (relative bioavailability), safety and tolerability~   "
105770|NCT02182947|"~     Most of the studies evaluating the roles of MRE and WCE conducted in pediatric patients have~     been retrospective with the main goal of making a diagnosis in patients with suspected IBD.~     The current study is the first prospective study in children with known IBD assessing the~     roles of MRE and WCE in identifying disease exacerbation. This study will help to identify if~     capsule endoscopy is superior or complementary to MRE in the evaluation of suspected disease~     exacerbation in IBD patients.~   "
105771|NCT02182934|"~     To assess the efficacy of Ginsana in improving hemoglobin re-oxygenation in healthy,~     recreational sports people and to assess the safety of the product.~   "
105772|NCT02182921|"~     The purpose of this study is to evaluate the visual outcome of the cataract surgery,~     including best uncorrected and corrected visual acuity, spherical equivalent, wavefront~     aberration and other measurements.~   "
105773|NCT02182908|"~     The primary aim of the study is to determine if the evolutivity of global and segmentary~     captation of FDG-F18, which can be measured in the wall of abdominal aorta aneurysm, is~     predictive of the 9 month evolution of diameter and volume of the aneurysm, measured globally~     and segmentary in angioscan.~   "
105774|NCT02182895|"~     The purpose of this research study is to test the safety and efficacy of a drug called~     saxagliptin (Onglyza) for treatment of type 2 diabetes in non-critically ill hospitalized~     patients who have an HbA1c of 7.5 or lower, on 1 or no non-insulin agent at home, or an HbA1c~     ≤7.0% on ≤ 2 non-insulin agents at home.~   "
105775|NCT02182882|"~     Study to assess the efficacy of ginsana in improving half-time hemoglobin re-oxygenation in~     healthy, recreational sportspeople and to assess the safety of the product~   "
105776|NCT02182869|"~     Study to evaluate the safety of combivent delivered in two different formulations~     (hydrofluoroalkane (HFA) or chlorofluorocarbon (CFC)) from a metered dose inhaler (MDI),~     using a cumulative dose response model in patients with COPD.~   "
105777|NCT02182856|"~     Study to compare the effects of nebulised salbutamol or ipratropium alone in patients with~     COPD with those of combined salbutamol and ipratropium nebuliser solution on arterial oxygen~     saturation (SaO2) and to characterise patients with COPD (chronic obstructive pulmonary~     disease) at risk of significant arterial oxygen desaturation following nebulised salbutamol.~   "
105778|NCT02182843|"~     The purpose of this study is to assess the clinical and radiographic outcomes in patients who~     undergo ACDF procedures using Cellentra Viable Cell Bone Matrix (VCBM), cortical allograft~     spacers, and the MaxAn® Anterior Cervical Plate System. Cellentra VCBM will be compared to~     published data for autograft in NDI (Neck Disability Index) improvement and radiographic~     success of fusion.~   "
105799|NCT02182570|"~     The safety and efficacy of WAL 801 CL (epinastine hydrochloride) Dry Syrup in the treatment~     of atopic dermatitis in children was evaluated and plasma drug concentrations were measured.~   "
105800|NCT02182557|"~     Study to investigate the safety and efficacy of WAL 801 CL Dry Syrup on pruritus associated~     with paediatric atopic dermatitis in comparison with that of Ketotifen Fumarate Dry Syrup and~     to confirm the appropriateness of dosage of WAL801 Dry Syrup.~   "
105801|NCT02182544|"~     Study to investigate the efficacy of WAL801CL Dry Syrup in comparison with ketotifen fumarate~     on pediatric perennial allergic rhinitis and to evaluate the safety of WAL801CL Dry Syrup~     compared to ketotifen fumarate and to confirm the appropriateness of dosage of WAL801 Dry~     Syrup.~   "
105779|NCT02182830|"~     This trial is designed to investigate the efficacy and safety of empagliflozin compared with~     placebo in hypertensive black/African Americans with type 2 Diabetes Mellitus. Since~     hyperglycaemia and hypertension are key risk factors for both micro- and macrovascular~     complications, assessment of both glucose and BP lowering effects of empagliflozin in~     hypertensive African American patients with type 2 Diabetes Mellitus could provide clinically~     highly relevant, new information for the use of empagliflozin.~      Essential hypertension is four times more common in African Americans than in Caucasians.~      One of the risk factors for hypertension is sodium sensitivity and approximately one third of~     the essential hypertensive population is responsive to sodium intake. There is a higher~     association of hypertension with sodium sensitivity in African American patients with type 2~     Diabetes Mellitus.~      The treatment duration of this trial (24 weeks) will enable assessment of the clinically~     relevant endpoint of a decrease in HbA1c, a well accepted measurement of chronic glycaemic~     control and the key secondary endpoints of decreases in systolic BP (SBP) and diastolic BP~     (DBP) at 12 and 24 weeks.~   "
105780|NCT02182817|"~     This prospective cohort study aims to determine if apparently healthy children with no~     significant co-morbidities who undergo general anaesthesia for minor surgery before 1 year of~     age will develop measurable deficits in neurocognitive development compared to apparently~     healthy children with no significant co-morbidities who do not undergo general anaesthesia or~     surgery.~   "
105781|NCT02182804|"~     This descriptive cross sectional study aims to directly compare the diagnostic capability of~     the probed-based confocal laser endomicroscopy (pCLE) and the magnifying narrow band imaging~     (M-NBI) in the Lugol's voiding lesions.~   "
105782|NCT02182791|"~     Study to determine the effects of nevirapine treatment on the pharmacokinetics of ethinyl~     estradiol (EE)/norethindrone (NET).~   "
105783|NCT02182778|"~     To validate the superiority of Gemcitabine/Cisplatin/S-1 over Gemcitabine/Cisplatin for~     unresectable biliary tract cancer.~   "
105784|NCT02182765|"~     Study to determine the effects of 28 days of nevirapine treatment on the steady-state~     pharmacokinetics of amprenavir and of abacavir and to further evaluate the pharmacokinetics~     of nevirapine in combination with amprenavir and abacavir compared to historical controls~     treated with nevirapine but without amprenavir or abacavir. In addition safety/tolerance of~     nevirapine, amprenavir and abacavir was to be assessed based on adverse events and clinical~     laboratory data.~   "
105785|NCT02182752|"~     The purpose of our study is to evaluate the effect of tramadol as an adjunct to ropivacaine~     local anesthetic solution in interscalene brachial plexus block for shoulder surgery.~   "
105786|NCT02182739|"~     Evaluation on the amelioration of symptom intensity of the indication and to evaluate drug~     tolerability.~   "
105787|NCT02182726|"~     The aim of the study is to investigate~        -  the indication for MOBEC in a dose of 15 mg per day~        -  the treatments patients were receiving before switching to 15 mg MOBEC~        -  how treatment with 15 mg is assessed compared with previous treatment~        -  how effective and safe treatment with 15 mg MOBEC is considered~   "
105788|NCT02182713|"~     The purpose of this study was to evaluate whether 2 puffs of fixed combination of aerosolized~     120 mcg salbutamol sulphate (equivalent to 100 mcg of the base) + 20 mcg ipratropium bromide~     confers significant additional protection against metacholine induced bronchoconstriction in~     asthmatic atopic patients when compared to 2 puffs of aerosolized 100 mcg salbutamol alone.~   "
105789|NCT02182700|"~     Study to evaluate the bronchodilator efficacy and safety of a fixed combination of salbutamol~     sulfate (120 mcg) + ipratropium bromide (20mcg) (Combivent® MDI) in aerosol plus spacer in~     adult patients with moderate-to-severe asthma crisis who arrived at the emergency room.~   "
105790|NCT02182687|"~     This study will compare stereotactic body radiation therapy (SBRT) to trans-arterial~     chemoembolization (TACE) as a bridging strategy for patients with HCC undergoing orthotopic~     liver transplantation. We propose that SBRT will be associated with longer time intervals~     between initial treatment and the need for retreatment, compared to TACE, as a bridge to~     orthotopic liver transplantation.~   "
105791|NCT02182674|"~     Study to demonstrate the comparability of two puffs of Combivent hydrofluoroalkane (HFA)~     inhalation aerosol (18 mcg ipratropium bromide/100 mcg albuterol sulfate / per puff) to two~     puffs of the marketed chlorofluorocarbon (CFC) containing product, Combivent (CFC) inhalation~     aerosol (18 mcg ipratropium bromide/103 mcg albuterol sulfate / per puff). The dose response~     profile, safety and pharmacokinetics of Combivent HFA formulation are to be characterized.~   "
105792|NCT02182661|"~     The objective of this study is to investigate the long-term safety of Ba253BINEB. Secondarily~     the long-term efficacy of Ba253BINEB is also investigated.~   "
105793|NCT02182648|"~     This research through using bispectral index to guide the induced dose and speed of etomidate~     lipid emulsion for pediatric total venous anesthesia,and to provide a reference for clinical~     anesthesia physician.~   "
105794|NCT02182635|"~     The objective of this study is to investigate the long-term safety of Ba253BINEB. Secondarily~     the long-term efficacy of Ba253BINEB is also investigated.~   "
105795|NCT02182622|"~     The purpose of this study is to first determine the highest dose of LDE225 combined wtih~     Docetaxel and Prednisone that can be given that does not cause unacceptable side effects when~     given to patients with castrate resistant prostate cancer who failed previous docetaxel~     therapy.~   "
105796|NCT02182609|"~     The objectives of this study are:~        -  To determine the safety and tolerability of a single dose of 99mTc-rhAnnexin V-128~          administered as an intravenous bolus over 10-20 seconds.~        -  To determine the biodistribution, pharmacokinetics and radiation dosimetry of~          99mTc-rhAnnexin V-128 in normal healthy adult volunteers.~   "
105797|NCT02182596|"~     For several years, the effective standard induction chemotherapy for AML has been limited to~     the association of anthracycline and aracytine. GO is the first effective targeted antibody~     used in leukemia patients. In a previous study, we showed efficacy and safety of fractionated~     doses of GO used as a single agent for treatment of adult AML patients in first relapse. In~     the present study the possibility of combining fractionated doses of GO to escalated doses of~     a 3+7 regimen old is studied in relapsed AML patients > 50 and <70 years.~   "
105798|NCT02182583|"~     The objective of this study is to investigate the efficacy and safety of Ba253BINEB during~     the continuous 4 weeks administration to the patients with COPD using Ba253MDI (Tersigan®~     aerosol) as the comparator drug.~   "
105802|NCT02182531|"~     Study to compare the bioavailable fraction of epinastine and pseudoephedrine when~     administered as a fixed dose combination in tablet form (new pharmaceutical formulation),~     with that obtained with each of these drugs when administered separately to healthy~     volunteers.~   "
105803|NCT02182518|"~     The aim of this trial is to evaluate the clinical efficacy and safety of Epinastine 10 mg +~     Pseudoephedrine 120 mg slow release (SR) administered twice a day, compared to Epinastine 10~     mg alone administered twice daily.~   "
105804|NCT02182505|"~     Study to demonstrate that at least one of the two doses of Berodual® (50 µg fenoterol~     hydrobromide + 20 µg ipratropium bromide and 25 µg fenoterol hydrobromide + 10 µg ipratropium~     bromide, 1 puff t.i.d.) administered via Respimat® device gives a bronchodilator response~     which is not inferior to that obtained from one dose of Berodual® (50 µg fenoterol~     hydrobromide + 21 µg ipratropium bromide, 2 puffs t.i.d.) administered via the MDI~     (chlorofluorocarbon-metered dose inhaler) with Aerochamber® and that the safety profile is at~     least as good when paediatric asthma patients are treated for four weeks.~   "
105805|NCT02182492|"~     Endoscopic sinus surgery (ESS) is widely considered to be the gold standard in the surgical~     management of chronic rhinosinusitis (CRS) that has failed maximal medical therapy.~     Nevertheless, the postoperation medical therapy was considered as a crucial procedure for the~     success of ESS. Both glucocorticoids and macrolide antibiotics have been recommended for the~     treatment of CRS, but their effect as postoperation medical therapies of ESS need more~     clinical data to clarify.~      The purpose of this prospective, randomized,study is to determine the effect of~     glucocorticoids and macrolide antibiotics for the postoperation medical therapy of ESS in~     different subtypes of CRS.~   "
105806|NCT02182479|"~     Study to demonstrate that at least one of the two doses of Berodual® (50 µg fenoterol~     hydrobromide/20 µg ipratropium bromide and 25 µg fenoterol hydrobromide/10 µg ipratropium~     bromide, 1 puff q.i.d.) administered via Respimat® gives a bronchodilator response which is~     not inferior to that obtained from one dose of Berodual® (50 µg fenoterol hydrobromide/21 µg~     ipratropium bromide, 2 puffs q.i.d.) administered via MDI and that the safety profile is at~     least as good in asthma patients treated for 12 weeks.~   "
105807|NCT02182466|"~     Aim of the registry is to evaluate all colon capsule endoscopies performed in Germany. This~     is to investigate safety, quality assurance and quality control of colon capsule endoscopy.~   "
105808|NCT02182453|"~     Study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI~     10773 administered to healthy Japanese male subjects with single rising oral doses (1, 5, 10,~     25, and 100 mg).~   "
105809|NCT02182440|"~     The purpose of this study is to determine whether recombinant Alkaline Phosphatase (recAP) is~     effective and save, and to determine the most effective dose, in the treatment of patients~     with acute kidney injury caused by sepsis.~   "
105810|NCT02182427|"~     Malnutrition (under-nutrition) occurs in approximately 30% of hospitalized adults worldwide~     and results in poor outcomes. However there is no universal method for diagnosing~     malnutrition. A group of experts created a set of 6 characteristics to identify malnutrition.~     The goal of this project is to determine whether these characteristics are the best~     indicators to identify malnutrition or if there are other factors that may better identify~     malnutrition. Because there is no gold standard definition for malnutrition, the~     investigators will compare the characteristics against outcomes such as length of stay,~     hospital readmission and death. Outcomes are also influenced by disease state, therefore,~     information on what brought the patient to the hospital and what happened to them in the~     hospital will be collected that allows the investigators to separate the effect of~     malnutrition from disease. The hypothesis for this study is that the malnutrition clinical~     characteristics and diagnosis criteria, as presented by the experts, are valid and reliable~     principles for the diagnosis of adult under-nutrition.~   "
105811|NCT02182414|"~     Study to investigate the relative bioavailability of 5 new 400 mg tablet formulations (trial~     formulation II prototypes) of BI 207127 compared to the current 200 mg BI 207127 tablet~     formulation (trial formulation I) in healthy male volunteers with the aim to identify the~     best formulation for further drug development (formulation finding part / trial part 1) and~     to investigate the effect of food on the relative bioavailability of the most promising one~     of these trial formulation II prototypes (food-effect part / trial part 2).~   "
105812|NCT02182401|"~     Study to investigate the pharmacokinetic drug-drug interaction potential of BI 207127 NA and~     BI 201335 NA on each other at steady-state and to quantify the effect of BI 207127 NA, and BI~     207127 NA combined with BI 201335 NA, on the activity of CYP 2C9 and CYP 3A4 using the probe~     substrates tolbutamide (CYP 2C9) and midazolam (CYP 3A4).~   "
105813|NCT02182388|"~     The objective of this trial was to investigate the safety, tolerability, pharmacokinetics,~     and relative bioavailability of BI 207127 NA as powder in the bottle (PIB) and solid oral~     dosage form (tablets) without and with food.~   "
105814|NCT02182375|"~     Study to investigate the effect of UGT1A1 inhibition by single and multiple oral doses of BI~     201335 on the single and multiple oral dose pharmacokinetics of raltegravir and to~     investigate safety and tolerability.~   "
105815|NCT02182362|"~     The main objective was to investigate the safety, tolerability and the pharmacokinetics (PK)~     of BI 201335 NA in healthy male subjects without Gilbert's syndrome or polymorphism (GS)~     following oral administration of a single dose (Day 1) and repeated doses (Days 4-24) of 20~     mg, 48 mg, 120 mg, and 240 mg. Additionally, the safety, tolerability, and the PK of the~     highest tolerated dose of BI 201335 NA (determined during the multiple-rising-dose phase)~     were assessed in healthy male subjects with GS over a 28-day continuous drug administration~     period.~   "
105816|NCT02182349|"~     Study to determine the pharmacokinetics (PK) of BI 201335 and total radioactivity including~     excretion mass balance, excretion pathways and metabolism following the oral administration~     of [14C]-BI 201335 at steady state.~   "
105817|NCT02182336|"~     The objective of this trial was to quantify the effect of oral single-dose (480 mg) and~     steady-state BI 201335 NA (240 mg BID) on intestinal and hepatic cytochrome P450 (CYP) and~     P-glycoprotein (P-gp) probe drugs as a means of predicting drug interactions. The AUCs for~     the probe drugs caffeine, warfarin, omeprazole, dextromethorphan, midazolam, and digoxin were~     assessed.~   "
117220|NCT02033200|"~     The purpose of this study is to see if Stendra causes any changes in vision, eye pressure,~     pupil dilation, and color vision in healthy males.~   "
105818|NCT02182323|"~     The objective of this study was to investigate the safety, tolerability, and pharmacokinetics~     of BI 201335 NA following administration of single rising doses from 4 mg to 1200 mg. In~     addition, the food effect on the bioavailability of BI 201335 NA (480 mg) was investigated.~   "
105819|NCT02182310|"~     To demonstrate that BI 201335 does not prolong the QT interval more than placebo.~      To assess the tolerability of 1200 mg of BI 201335 as single dose in female subjects~     (double-blind, randomised, placebo-controlled) before inclusion of female subjects in the~     cross-over part of the trial.~   "
105820|NCT02182297|"~     The objective of this trial was to investigate safety, tolerability, and pharmacokinetics of~     BI 201335 ZW after administration of single rising doses from 40 mg to 480 mg of BI 201335 NA~     in healthy Japanese male volunteers.~   "
105821|NCT02182284|"~     The objective of this study was to establish the relative bioavailability of a new soft~     gelatin capsule (SGC) formulation of BI 201335 NA compared to the current solution~     formulation (powder in bottle, PIB) for two doses (40 mg, 240 mg) in a parallel, two-way~     cross-over study design.~   "
105822|NCT02182271|"~     The objective of the current study is to investigate safety, tolerability, and~     pharmacokinetics of BI 201335 ZW following administration of single rising doses from 5 mg to~     1500 mg. In addition Two stage intra-subject bioavailability comparison of 600 mg BI 201335~     ZW as a liquid formulation given with and without food.~   "
105823|NCT02182258|"~     The primary objective of this trial was to assess the safety and tolerability of BIBF 1120~     administered as intravenous (iv) infusions of 1, 3, 10, and 20 mg, and to assess the absolute~     bioavailability of orally administered 100 mg BIBF 1120 as soft gelatine capsules. A~     secondary objective was the exploration of the pharmacokinetic (PK) of BIBF 1120 after single~     iv dosing, including dose proportionality.~   "
105824|NCT02182245|"~     The primary objectives of this trial were to determine the safety, tolerability, and MTD of~     BIBF 1120 when added to standard therapy with carboplatin and paclitaxel~   "
105825|NCT02182232|"~     The primary objectives of this trial were to determine the MTD of BIBF 1120 in combination~     with carboplatin and paclitaxel, pharmacokinetics and objective response of treatment~   "
105826|NCT02182219|"~     The primary objective of this study was to determine the safety and Maximum tolerated dose~     (MTD) of BIBF 1120 combination therapy with docetaxel and prednisone in patients with hormone~     refractory prostate cancer. Secondary objectives were to characterise the pharmacokinetic~     profiles of BIBF 1120 and docetaxel and possible Pharmacokinetic (PK) interactions between~     BIBF 1120 and docetaxel and to obtain preliminary information on anti-tumour activity.~   "
105827|NCT02182206|"~     Maximum Tolerated Dose (MTD), safety, pharmacokinetics, efficacy of BIBF 1120,~     pharmacodynamic parameters (Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI))~   "
105828|NCT02182193|"~     To assess pharmacokinetics and the relative bioavailability of a single dose of BIBF 1120~     soft gelatine capsule charge 1 vs. BIBF 1120 soft gelatine capsule charge 2 vs BIBF 1120~     drinking solution in healthy male subjects respectively. To establish an in-vitro-in-vivo~     correlation (IVIVC) for oral soft gelatine capsules with 150 mg BIBF 1120 in healthy male~     volunteers (if feasible)~   "
105829|NCT02182180|"~     The purpose of this study is to collect samples of blood, urine, cerebrospinal fluid (CSF,~     the fluid that surrounds the brain and spinal cord), wound tissue and/or wound fluids, and~     other body fluids and tissues from people who have been seriously injured or ill. The samples~     will be used to develop and assess tests and/or tools that doctors can use to decide the best~     treatment plan for seriously injured or ill military personnel and for civilians. Additonal~     protocols to use the samples will be submitted as separate protocols.~   "
105830|NCT02182167|"~     We will conduct a randomized placebo controlled trial to determine whether administration of~     intravenous (IV) NAC to participants with TB DIH, in dosages similar to that used in~     paracetamol poisoning, can improve recovery from hepatotoxicity.~   "
105831|NCT02182154|"~     To assess the metabolic profile,~      to obtain the mass balance after oral administration,~      to determine the concentration of [14C]-radioactivity in blood cells, plasma, urine and~     faeces,~      to determine BIBF 1120 and BIBF 1202 concentrations in plasma, urine, and faeces, if~     feasible,~      to determine the protein binding of [14C]-radioactivity,~      to determine the pharmacokinetics of BIBF 1120, BIBF 1202 and total radioactivity after a~     single oral administration of [14C]-BIBF 1120 in healthy volunteers~   "
105832|NCT02182141|"~     Maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of BIBF 1120,~     pharmacodynamics~   "
105833|NCT02182128|"~     Confirmation of BIBF 1120 administered from 150 mg twice daily (b.i.d.) to 250 mg b.i.d. as~     safe and tolerable treatment in Japanese patients with advanced solid tumours, overall~     safety, pharmacokinetic parameters, biomarkers, and efficacy of BIBF 1120.~   "
105834|NCT02182115|"~     Staphylococcus aureus (SA) healthcare-associated infections (HAI) cause significant morbidity~     and mortality. SA causes 15% of all HAI and 30% of surgical site infections (SSIs). Each year~     over 40 million Americans undergo operations, 1-10% of whom will acquire SSIs. Such~     infections double the length of hospitalization and risk of dying, and increase U.S. health~     care costs by $5-10 billion/year. We need effective interventions to prevent SSIs caused by~     either methicillin-susceptible (MSSA) or methicillin-resistant (MRSA) strains. Nasal carriers~     of SA (25-30% of adults) have a 2-14 times greater risk than non-carriers of acquiring an SA~     SSI. A potential prevention approach is routine pre-operative screening of patients, followed~     by decolonization of identified SA carriers.~   "
105835|NCT02182102|"~     The primary objective was to determine the safety, tolerability and maximum tolerate dose~     (MTD) of BIBF 1120 in combination with pemetrexed. Secondary objectives were to characterize~     the pharmacokinetic profiles of BIBF 1120 and pemetrexed and to obtain preliminary~     anti-tumour efficacy information.~   "
105836|NCT02182089|"~     The overall goal is to evaluate the predictive accuracy of a measure of autoregulatory~     adequacy derived from CVInsight and compare it with other measures in recognizing hypotensive~     events during hemodialysis..~   "
105837|NCT02182076|"~     Study to assess pharmacokinetics and the extend of absorption of a single dose of BIBF 1120~     soft gelatine capsule with food effect (BA) in healthy subjects respectively.~   "
117250|NCT02032797|"~     The aim of the study is to determine whether 5 or 7 days of progesterone supplementation~     before transfer of a day 5 cryopreserved thawed embryos in an artificial cycle results in a~     significant higher pregnancy rate.~   "
105838|NCT02182063|"~     The aim of this study was to evaluate the efficacy of two different doses of BIBF 1120 (250~     mg twice daily versus 150 mg twice daily) in an exploratory manner. Safety, quality of life~     and pharmacokinetic parameters on a sub-sample of 20 patients were also analysed for the two~     different doses.~   "
105839|NCT02182050|"~     The overall purpose of this phase II trial was to evaluate the efficacy of 250 mg BIBF 1120~     twice daily (BID) versus 150 mg BIBF 1120 BID in patients with advanced non-small-cell lung~     cancer (NSCLC) who had failed at least one prior chemotherapy regimen. In addition, safety~     data for the two different dosages were collected and analysed.~   "
105840|NCT02182037|"~     A study to assess safety, pharmacokinetics and the effect of BIBT 986 BS, given as BIBT 1011~     BS, on coagulation parameters.~   "
105841|NCT02182024|"~     To assess the effect of different degrees of renal impairment on the pharmacokinetics and~     pharmacodynamics of dabigatran etexilate administered orally.~   "
105842|NCT02182011|"~     Primary objective: to evaluate the procoagulant effect of TNK-tPA compared to rt-PA and~     streptokinase, administered to patients with AMI, by measuring the concentration of TAT at 2~     hours after the start of treatment versus baseline values.~      Secondary objective: change from baseline in concentration of TAT at 6 and 24 hours; change~     from baseline in concentration of D-dimers, F1+2, PAI-1, PAP at 2, 6 and 24 hours. Incidence~     of adverse events (AE's), in -hospital complications, major or minor bleedings and serious~     adverse events.~   "
105843|NCT02181998|"~     The primary objective of ASSENT 3 Plus (the same as for ASSENT 3) was to evaluate the safety~     and efficacy of full dose tenecteplase combined with unfractionated heparin (UFH, group A)~     and full dose tenecteplase combined with enoxaparin (ENOX, group B). An additional objective~     in ASSENT 3 Plus was to describe the different time intervals in the prehospital phase.~   "
105844|NCT02181985|"~     The objective of ASSENT 3 was to evaluate the safety and efficacy of full dose tenecteplase~     with heparin sodium (group A), full dose tenecteplase combined with enoxaparin (group B) and~     half dose tenecteplase combined with abciximab and heparin sodium (group C).~   "
105845|NCT02181972|"~     The primary objective of this study was to assess the efficacy and safety of Gingko biloba~     film-coated tablets in improving cognitive function and neuropsychological functioning of~     middle-aged cognitively intact adults.~   "
105846|NCT02181959|"~     The purpose of this trial was to evaluate the safety and tolerability of a galenic~     formulation of Pharmaton® capsules containing 2-Dimethylaminoethanol (DMAE) in healthy~     volunteers.~   "
105847|NCT02181946|"~     The purpose of this study was to determine the effects of nevirapine on the steady state~     pharmacokinetics of fluconazole and to assess the steady-state pharmacokinetics of nevirapine~     when given in combination with fluconazole.~   "
105848|NCT02181933|"~     The primary objective of the study was to evaluate the efficacy of nevirapine versus ZDV+3TC~     (Zidovudine + Lamivudine), when administered in labor and again at postdelivery, in reducing~     peripartum mother to child transmission of HIV (Human Immunodeficiency Virus).~      The secondary objective was to assess the overall HIV transmission rate between the 2 groups~     (intrauterine, intrapartum and postpartum up to 6 weeks) as well as to explore the~     relationship between infection and timing of maternal dose relative to birth, infant feeding~     method, maternal peripheral blood viral load, and other potential risk factors for~     transmission.~      Following the introduction of the second and third Amendments to the Protocol, 2 substudies~     were added. The objectives of these substudies were to evaluate the frequency of~     resistance-conferring mutations to nevirapine (Amendment 2) and to ZDV+3TC (Amendment 3); to~     determine whether there was a reversion of any resistant virus to the wild type; and to~     determine if the resistant virus was transmitted from the mother to the child.~   "
105849|NCT02181920|"~     Study to evaluate the efficacy of metamizole in reducing morphine requirements in patients~     with moderate to severe chronic cancer pain in comparison to administration of placebo or~     diclofenac.~   "
105850|NCT02181907|"~     Study to investigate the bioequivalence of UH-AC 62 XX tablets 10 mg (TF4) and UH-AC 62 XX~     capsules 10 mg by single administration in healthy volunteers.~   "
105851|NCT02181894|"~     Placing artificial airways in infants is often performed under emergent life-saving~     conditions, which necessitates a procedure that is both accurate and efficient. Intubations~     of the newborn are often necessary before an accurate weight can be reported and estimations~     are often inaccurate. The current national standard uses body weight to predict the~     appropriate tube depth yet this approach tends to place the tube too deep for the smallest~     and most vulnerable neonate; and placement accuracy of any size infant is only 50-70%. The~     consequence of malpositioned ETTs resulting from poor oxygenation, lung hyperinflation,~     pneumothoraces and death has been suggested to cost $20 to $54 million annually.~      The morbidity and the financial impact suggest an optimal and accurate approach to place ETT~     in neonates has not been identified. Other methods to estimate the proper depth of the~     orotracheal tube have shown promise yet no comparison studies have been performed.~     Identifying the most accurate method to safely place neonatal orotracheal tubes will improve~     placement precision and reduce adverse events and their associated costs.~      Hypothesis~      Compared to weight, sternal to xyphoid length and shoulder to elbow length, the nasal to~     tragus length will become the most accurate method for predicting the safe depth of orally~     placed neonatal endotracheal tubes.~   "
105852|NCT02181881|"~     The investigators will pilot test the intervention by randomizing 30 couples to one of three~     conditions: 1) DuoPACT, the newly-developed couples intervention; 2) Life Steps, a~     standardized antiretroviral adherence intervention for HIV+ individuals; and 3) a treatment~     as usual (TAU) assessment-only control condition. After randomization, intervention sessions~     will be delivered weekly (6 DuoPACT sessions, or 3 Life Steps sessions). All couples will be~     assessed pre/post intervention to evaluate intervention acceptability and feasibility.~   "
105868|NCT02181673|"~     The purpose of this study is to evaluate the efficacy of intravenously (administration of a~     fluid into the vein) administered golimumab 2 milligram per kilogram (mg/kg) in participants~     with active psoriatic arthritis (a chronic inflammatory arthritis that is associated with~     psoriasis).~   "
105869|NCT02181660|"~     The objectives of this study are to determine the safety and tolerability of ASP2215 as well~     as the maximum tolerated dose (MTD) based on the onset of dose limiting toxicity (DLT) and/or~     determine the recommended dose (RD) of ASP2215 for the next phase in subjects with relapsed~     or treatment-refractory acute myeloid leukemia (AML).~   "
105853|NCT02181868|"~     The mandible bears a wide range of mechanical load from the contraction of masticatory~     muscles, and has a significant function in normal chewing movements. Mandibular fractures are~     the most common maxillofacial fractures, accounting for 40%-71% of all maxillofacial fracture~     cases with an average of 62%. The etiology of mandibular fractures mainly includes assaults,~     road traffic accidents (RTAs), falls, and sports injuries. Although a wide variance exists in~     the reported percentage of anterior mandible fractures, aggregate analysis approximates these~     fractures at 17% of all mandibular fractures. The rigid internal fixation (RIF) technique has~     become a common treatment for mandibular fractures, in which titanium plates are used in the~     operation. Some patients have to remove the titanium plates in a second operation following~     bone healing because of sequelae, such as stress shielding. Biodegradable plates and screws~     have been developed to eliminate the problems associated with titanium fixtures. In this~     study, we aim to compare the clinical performance between biodegradable and titanium fixation~     systems after 12 months of follow-up in fixation of mandibular symphysis and parasymphysis~     solitary fractures. We also investigate the stress distributions of biodegradable and~     titanium fixation systems at mandibular symphysis solitary fracture on the conditions of~     intercuspal position, labial teeth occlusion, and premolar and molar occlusion using finite~     element analysis.~   "
105854|NCT02181855|"~     Patients with atypical symptoms of objectified gastroesophageal reflux disease will be~     treated by full-thickness gastroplication and the effect of this intervention will be~     measured by questionnaires and clinical diagnostics (for example pH/MII).~   "
105855|NCT02181842|"~     The purpose of this survey is to evaluate the effects on glycemic control and to evaluate the~     safety of long-term use of pioglitazone tablets (Actos Tablets) in type 2 diabetic patients~     with inadequate glycemic control and a prior history of cerebral infarction.~   "
105856|NCT02181829|"~     The purpose of this study is to find out what effects, good and/or bad, radiation has on the~     lungs has on the patient and on synovial sarcoma which has spread to the lungs. The standard~     treatment for synovial sarcoma which has spread to the lungs is chemotherapy with or without~     surgery to remove the tumors in the lungs. However, tumors often come back in the lungs after~     chemotherapy and/or surgery. Since synovial sarcoma is known to be sensitive to radiation,~     this study is looking at whether radiation therapy which is targeted to the entire lung can~     further reduce the chances of the cancer returning. This type of radiation is commonly used~     in other types of sarcoma to treat the cancer once it has spread to the lungs and it may be~     very useful in synovial sarcoma as well.~      In this study, a special type of radiation will be used, called Intensity Modulated Radiation~     Therapy (IMRT). With IMRT the radiation beams are more customized to focus more radiation on~     the tumor cells while delivering less radiation to areas like the heart. The goal of this~     study is also to measure pulmonary toxicity and see if IMRT is feasible and has less~     toxicity.~   "
105857|NCT02181816|"~     The purpose of this survey is to evaluate the safety and efficacy of long-term use of~     azilsartan/amlodipine combination tablets LD & HD (Zacras Combination Tablets LD & HD) in~     hypertensive patients in daily medical practice.~   "
105858|NCT02181803|"~     This 3-part dose titration study will assess MK-8189 safety, tolerability, pharmacokinetics~     (PK), and central nervous system activity. Part 1 will assess MK-8189 administered as~     monotherapy in participants with schizophrenia. Part 2 will assess MK-8189 administered as~     add-on to atypical antipsychotic treatment in participants with schizophrenia. Part 3 will~     assess monotherapy with MK-8189 in healthy participants, including those of Japanese descent.~     The primary hypothesis is that there is at least one dose of MK-8189 that is generally safe~     and well-tolerated which will have the desired PK parameters in participants with~     schizophrenia.~   "
105859|NCT02181790|"~     Psoriasis is a common skin disease that can affect 1-3% of the population. For more severe~     psoriasis, oral medication such as acitretin is sometimes given. While acitretin may be~     sufficient for treatment of some patients, psoriasis of the palms and soles is particularly~     challenging to treat, and may not respond to acitretin alone.~      In this study, the focus is on patients who have psoriasis of the palms and soles, and are~     currently taking acitretin. The aim is to initially recruit 10 patients and offer them~     treatment with a laser, the excimer laser, to one palm and one sole. Patients will receive~     laser treatment twice weekly for a total of 8 weeks, while also taking their acitretin~     tablet. If the side treated with the excimer laser shows greater improvement compared to the~     other side, the second part of the study will be conducted.~      In this second part, another 15 patients will be included. These patients will receive twice~     weekly treatments with the excimer laser to one both palms and/or soles, for a total of 8~     weeks. The aim is to prove that the addition of excimer laser to treatment with acitretin~     will lead to greater improvement of psoriasis on palms and soles.~   "
105860|NCT02181777|"~     The purpose of this study is to assess the feasibility of a social skills training group for~     people with psychosis.~   "
105861|NCT02181764|"~     The objective of this study is to assess the safety and tolerability of KRN23 after a single~     subcutaneous (SC) administration in subjects with X-linked hypophosphatemic~     rickets/osteomalacia (XLH) in Japan or Korea.~   "
105862|NCT02181751|"~     Our goal in this study is to decrease the severity of Post-Traumatic Stress Disorder symptoms~     in sexually abused children between the ages of 8-12. We also aim to improve children's~     quality of life, decrease levels of anxiety and depression as well as improve their levels of~     attachment.~   "
105863|NCT02181738|"~     The purpose of this study is to evaluate the efficacy and safety of Nivolumab in previously~     treated (cohorts, A, B & C) or newly diagnosed (cohort D) classical Hodgkin Lymphoma~     subjects.~   "
105864|NCT02181725|"~     The purpose of this study is to evaluate whether a multimodal rehabilitation program~     effectively reduces functional disability in adolescents with chronic musculoskeletal pain,~     compared to care as usual.~   "
105865|NCT02181712|"~     To assess the safety and feasibility of mesenchymal stem cells therapy in patients with~     transplant related bronchiolitis obliteran syndrome (BOS)~   "
105866|NCT02181699|"~     This is a first in human, non-randomized, open-label, dose escalation study to investigate~     the safety, pharmacokinetics, immunogenicity and pharmacodynamics of repeat doses of KHK2823.~   "
105867|NCT02181686|"~     The objective of this study is to confirm the safety and efficacy of the new Sentus OTW QP LV~     lead and Iperia ICD family. The study focuses on the safety and efficacy of the QP device~     system.~   "
105870|NCT02181647|"~     The primary goal of the study is to conduct a rigorous evaluation of the sexual abuse~     prevention program entitled, Safe Touches: Personal Safety Training for Children (Safe~     Touches). The main study hypothesis is that children who receive the Safe Touches~     intervention will show greater improvement on their knowledge of inappropriate touches~     compared to children who do not receive the intervention.~   "
105871|NCT02181634|"~     Patients with advanced or metastatic cholangiocarcinoma (CCA) who are not eligible for~     curative surgery, transplantation, or ablative therapies will receive nab-paclitaxel and~     gemcitabine chemotherapy.~      The purpose of this study is to evaluate the effectiveness and safety of the combination of~     nab-paclitaxel and gemcitabine. The effectiveness will be determined by improvement in the~     length of time during and after treatment, that the CCA does not get worse.~   "
105872|NCT02181621|"~     This study is a prospective comparative study to determine if an Iodine Gel (Iodosorb◊) is~     better than standard dressing (Solosite◊ gel) in disruption of biofilm (small microorganism~     bacteria similar to plaque on teeth) on the wound bed diabetic foot ulcers.~      ◊ Trademark of Smith & Nephew~   "
105873|NCT02181608|"~     Background:~      - Researchers want to see if people with alcohol dependence have more trouble learning to~     feel calm, or learn to fear things more easily, than non-alcoholics and to study how early~     life stress (ELS) affects these things.~      Objective:~      - To see if people with alcohol dependence and/or ELS have a harder time learning to feel~     calm than people without these conditions.~      Eligibility:~        -  Adults age 21 65 with diagnosed alcohol dependence, with/without ELS.~        -  Healthy volunteers age 21 65 with/without ELS.~      Design:~        -  All participants will be screened with medical history and physical exam. They will have~          blood and urine tests, and a psychological assessment.~        -  Participants with alcohol dependence will:~        -  be at the NIH Clinical Center for 4 weeks. Then they will have weekly telephone calls~          and 3 in-person visits over 3 months.~        -  follow the NIH alcohol treatment program during the study. They cannot take psychiatric~          medications.~        -  rate their alcohol craving, depression, and anxiety throughout the study.~        -  have fear conditioning and extinction sessions that use noise and mild electric shock.~          Some take place during a functional MRI (fMRI) scan. Participants will lie in a machine~          that takes images, while they perform tasks.~        -  listen to recordings that describe stressful events. They will rate their feelings and~          have blood drawn through an intravenous (IV) line.~        -  have their hormone response to stress tested. They will take a pill and get a hormone~          via an IV, then have blood drawn.~        -  Healthy volunteers will:~        -  have 2 inpatient stays, each lasting a few days. They will answer questions about how~          they feel.~        -  have fear conditioning and extinction sessions, including fMRI.~        -  have blood drawn several times.~   "
105874|NCT02181595|"~     Background:~      - Women with Primary Ovarian Insufficiency (POI) have ovaries that stopped working normally~     before they turned 40. This usually causes infertility, which challenges many women with the~     condition to ask themselves, Why me? This kind of question is about our human existence, or~     what some call an existential view of life. Researchers have learned that spirituality and~     finding existential purpose help women with POI. So does meeting other women with the same~     problem. Researchers want to find new ways to help women with POI cope with it.~      Objective:~      - To develop and test a practice for women with POI called Deep Reading.~      Eligibility:~      - Women enrolled in another POI protocol, who can read and speak English.~      Design:~        -  Participants will first have an individual visit or phone call. They will describe~          spiritual or existential practices they have done. They will also answer questions about~          spiritual and existential health and daily functioning.~        -  They will join a group for 6 weekly sessions. Each session will be 60 90 minutes.~        -  In each group session, a coordinator will teach participants about Deep Reading. They~          will read a piece of up to 1000 words. They will think about the piece and then talk~          about it with the group.~        -  Between sessions, participants will practice Deep Reading at least once for 15 20~          minutes on their own. They will check in once with another group member. They will keep~          a log of these activities.~        -  After session 3, participants will answer questions online about wellbeing and~          satisfaction.~        -  At session 6, participants will answer questions online about wellbeing. They will~          answer questions about their overall experience.~        -  One and 3 months after the sessions end, participants will again complete online~          wellbeing questionnaires and report on their continued practice of Deep Reading.~   "
105875|NCT02181582|"~     Background:~      - A brain protein called translocator protein (TSPO) shows changes in some brain diseases. A~     radioactive drug called 11C-(R)-PK 11195 is used to take pictures of TSPO using a camera~     called positron emission tomography (PET). Researchers want to find out how well 11C-(R)-PK~     11195 takes the pictures.~      Objective:~      - To evaluate the radioactive chemical 11C-(R)-PK 11195.~      Eligibility:~      - Healthy volunteers ages 18-55.~      Design:~        -  Participants will be screened with a medical exam.~        -  Participants will have scans at up to 4 visits.~             -  PET scan using 11C-(R)-PK 11195:~                  -  A small tube (catheter) will be put into an artery at the wrist or elbow, by a~                    needle. The needle will be removed, leaving only the catheter in the artery.~                    Blood samples will be taken through this catheter.~                  -  Another catheter will be placed into a vein in the arm or hand.~                  -  11C-(R)-PK 11195 will be injected through the second catheter.~                  -  The PET scanner is shaped like a doughnut. Participants will lie on a bed that~                    slides in and out of it. They may get a plastic mask for their face and head.~             -  Participants will receive a dose of emapunil by mouth. Participants will then have~               another PET scan.~             -  Participants may have a magnetic resonance imaging (MRI) scan. The MRI scanner is a~               metal cylinder surrounded by a magnetic field. The participant will lie on a table~               that can slide in and out of the cylinder. Participants will get earplugs for the~               loud knocking noises.~        -  After each scan, participants will get a follow-up phone call. Two to seven days after~          taking emapunil, participants will return for a follow-up visit.~   "
105876|NCT02181569|"~     Despite research establishing the relationship between sleep disturbances and alcohol use,~     there is no clear understanding or model for what occurs once individuals who seek inpatient~     alcoholism treatment are discharged from rehabilitation facilities and attempt to integrate~     back into their homes and communities. The purpose of this investigation will be to~     characterize sleep patterns, perceptions, and beliefs throughout the process of alcohol~     rehabilitation. The misuse of alcohol is a global public health concern that compromises both~     individual and societal wellbeing, resulting in an estimated 2.5 million deaths annually. The~     National Institute on Alcohol Abuse and Alcoholism (NIAAA) distinguishes alcoholism by~     craving, loss of control, physical dependence, and tolerance (NIAAA, Alcohol Use Disorders).~     The relationship between alcohol use and sleep disturbances is complex and bidirectional, but~     sleep disturbances are common among alcoholics during phases of drinking, withdrawal, and~     abstinence. Outcome expectancies, behavioral capability, and self-efficacy beliefs are~     central constructs in the Social Cognitive Theory and will be measured directly in this study~     using both quantitative and qualitative methods. A mixed methods approach will be used to~     study the following aims: a) to assess individuals' perceptions of and experiences with sleep~     during alcohol rehabilitation, b) to describe sleep patterns, perceptions, and beliefs among~     alcohol-dependent individuals throughout the transition from a clinical research facility~     providing rehabilitation treatment back to the community, c) to assess whether sleep-related~     beliefs and/or behavior of individuals are predictive of sleep quality or relapse to~     drinking, and d) to assess whether sleep quality predicts relapse. Adult research~     participants admitted to the inpatient behavioral health unit and enrolled on to the NIAAA~     intramural study NCT 0010693: Assessment and Treatment of People with Alcohol Drinking~     Problems will be recruited for participation in this study (n=215). Sleep quality and~     duration will be quantitatively assessed approximately one week prior to discharge from the~     inpatient facility and again 4-6 weeks post-discharge. A sub-set of participants will be~     asked to wear actiwatches (accelerometers) to provide objective data on sleep throughout the~     transition from inpatient to outpatient. In addition to quantitative measures, qualitative~     semi-structured interviews will be conducted with a subset of 25 participants (to reach 25~     completed cases) within a week of the scheduled discharge date and again four to six weeks~     post-discharge to assess perceptions of sleep during recovery. The proposed study will fill a~     gap in the literature by characterizing sleep throughout the rehabilitation process and~     ongoing maintenance of abstinence.~   "
117251|NCT02032784|"~     Our hypothesis is that prophylactic administration of 5 days of Octreotide following EMR or~     ampullectomy in patients with duodenal and ampullary adenomas greater than or equal to 10mm.~   "
105877|NCT02181556|"~     One of the treatments generally used to treat this disease is a chemotherapy called FOLFIRI.~     The purpose of this study is to improve the efficacy of the chemotherapy by adding a protein,~     similar to immunoglobulins, aflibercept, and to assess their tolerance.~      Aflibercept is a protein that has already been studied in the treatment of metastatic~     colorectal cancers, in combination with a chemotherapy involving irinotecan in addition to~     5FU (FOLFIRI) as 2nd line treatment. It is marketed in Europe and it is authorized in the~     United States. Its addition to this chemotherapy combination has in fact brought about a~     benefit in terms of progression-free survival and overall survival.~      The purpose of the study is to evaluate the efficacy and tolerance of this combination rather~     in the initial approach to the treatment of metastatic colorectal cancers and hence to~     evaluate it as 1st line treatment~   "
105878|NCT02181543|"~     The purpose of this study is to determine efficacy of intraoperative clonidine to prevent~     postoperative agitation in pediatric anesthesia with sevoflurane.~   "
105879|NCT02181530|"~     This study will use retrospective data to evaluate the safety and efficacy of OZURDEX®~     (dexamethasone intravitreal implant 0.7 mg) in the treatment of macular oedema due to retinal~     vein occlusion (RVO) in clinical practice. No intervention will be administered as part of~     this study.~   "
105880|NCT02181517|"~     This is a safety and efficacy study of abicipar pegol in patients with neovascular~     age-related macular degeneration to establish comparability between Japanese and~     non-Japanese.~   "
105881|NCT02181504|"~     This is a safety and efficacy study of abicipar pegol in patients with neovascular~     age-related macular degeneration to establish comparability between Japanese and~     non-Japanese.~   "
105882|NCT02181491|"~     There has been recent interest in the role of the 5-HT1B receptor as a possible modulating~     factor in cocaine dependence, certainly in preclinical models. The Yale Positron Emission~     Tomography (PET) Center has developed a novel 5-HT1B receptor antagonist radioligand,~     [11C]-P943, which has been validated in human studies. We hypothesize that the 5-HT1B~     receptor plays a key role in cocaine dependence. The long term goal of this project would be~     to study pharmacological manipulation of the 5-HT1B receptor as a potential molecular target~     for cocaine dependence.~   "
105883|NCT02181478|"~     This clinical trial studies intra-osseous donor umbilical cord blood and mesenchymal stromal~     cell co-transplant in treating patients with hematologic malignancies. Giving low doses of~     chemotherapy and total-body irradiation before a co-transplant of donor umbilical cord blood~     and mesenchymal stromal cells into the bone (intra-osseous) helps stop the growth of cancer~     cells. It may also stop the patient's immune system from rejecting the donor's stem cells.~     The donated stem cells may replace the patient's immune cells and help destroy any remaining~     cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can~     also make an immune response against the body's normal cells. Giving cyclosporine and~     mycophenolate mofetil at the time of transplant may stop this from happening.~   "
105884|NCT02181465|"~     Pancreatic, gastric, and colorectal cancers have all been shown to overexpress the gastrin~     gene and to be sensitive to the trophic effects of the gastrin in animal models. The~     hypothesis of this study is that G17DT will elicit specific and high-affinity antibodies that~     will bind gastrin-17, thus preventing the trophic activity of cancer cells.~   "
105885|NCT02181452|"~     Chronic liver disease/fibrosis can be the result of various causes, and the result is that~     the liver tissue becomes stiff. ShearWave™ elastography, available on the Aixplorer®~     ultrasound system, is a method that can be used to measure the stiffness of organs in the~     body, for example the liver.~      This study will evaluate how this technology performs as a non-invasive test to stage liver~     fibrosis in patients with chronic liver disease.~   "
105886|NCT02181439|"~     It is a single-center, prospective clinical study of a medical device, controlled,~     randomized, non-stratified, double-blind (neither the patient nor the parents know which area~     is irradiated / practitioner who performs the measures and evaluates the class I achievement~     or non also ignores the irradiated area) .~      Children included in this clinical trial will be their own control, an area receiving LASER~     irradiation the other receiving a simulation LASER irradiation (placebo side, inactive laser)~     .~      In the maxilla, it will be segmented using a technique by the introduction of sectional side~     (portion of elgiloy arch supporting molars, canines and premolars) which serve as a support~     for Intermaxillary Strength II (or Intermaxillary Elastics II).~      The patient should put his own Intermaxillary Elastics II, force adapted to the amount of~     class II dental, and this 24h/24. The patient should position him/herself these~     intermaxillary elastics in the first mandibular molar to the maxillary canine ; their action,~     in case of maximum mandibular anchorage, is to reduce maxillary canine in order to obtain~     reports of class I. In the mandible, a maximum anchor will be realized. Maximum molar anchor~     is to place the roots of mandibular molars in the vestibular cortex in order to anchor them~     there. This allows the lower canines, premolars and maxillary molars under the action of FIM~     without causing mutual advancement of the mandibular arch.~      This procedure does not differ from the usual treatment. The application of laser diode~     appears, by biomodulatrice action, to show promising results on accelerating the kinetics of~     tooth movement during orthodontic treatment. The main hypothesis of the research is an~     increase in the rate of correction of Class II irradiated side, i.e. a 1-month shortest delay~     in obtaining the class I for irradiated areas vs. non irradiated ones.~      The main objective of this study is to evaluate the effect of the application of low energy~     laser (LLLT) on the time required to obtain a Class I canine on patients undergoing FIM II~     (Class II elastics)~   "
105887|NCT02181426|"~     Ketorolac is administered as current practice to the majority of patients undergoing knee~     arthroscopy, the appropriate dose of ketorolac to be administered has not been evaluated.~   "
105888|NCT02181413|"~     The purpose of this study is to determine the effect of ixazomib citrate maintenance therapy~     on progression-free survival (PFS), compared to placebo, in participants with newly diagnosed~     multiple myeloma (NDMM) who have had a response (complete response [CR], very good partial~     response [VGPR], or partial response [PR]) to induction therapy followed by high-dose therapy~     (HDT) and autologous stem cell transplant (ASCT).~   "
105889|NCT02181400|"~     This pilot study aims to establish that treatment with near infrared light (NIR) reduces~     diabetic macular oedema in patients suffering diabetic retinopathy by exerting a positive~     beneficial effect at retinal cellular level.~      Diabetic retinopathy is a common cause of severe loss of vision and the most common cause of~     blindness in individuals between the ages of 20 and 65 years in developed countries.Swelling~     of the central retina or macular oedema. Patients will be treated in an office clinic,three~     times a week for a treatment duration of 2 minutes per session, a total of 12 times over the~     duration of 4 weeks and will be assessed at 8 weeks to establish any change induced in~     retinal oedema.Safety folllow up will be assessed at 3 and 6 months post treatment.~   "
105973|NCT02180295|"~     The study will evaluate the consistency of 3 lots of inactivated VZV vaccine for safety,~     tolerability, and immunogenicity in healthy adults. The primary hypothesis of the study is~     that the 3 lots of inactivated vaccine will demonstrate similar immunogenicity at 28 days~     after the fourth dose.~   "
105890|NCT02181387|"~     The hypothesis is if administration of acetaminophen during labor will reduce the amount of~     neuraxial pain medication required for comfort. For the study, Acetaminophen or placebo~     capsules will be administered at the time of neuraxial analgesia placement and then~     administered every 6 hours until delivery. Overall consumption of neuraxial pain medication~     will be determined.~   "
105891|NCT02181374|"~     The purpose of this study is to evaluate the diagnostic value of serum NT - proBNP in stroke~     associated with nonvalvular atrial fibrilltion.~   "
105892|NCT02181361|"~     The Secondary Prevention of patients with an initial cardioembolic stroke associated with~     nonvalvular atrial fibrillation.~   "
105893|NCT02181348|"~     Anemia is one of the major health problems of the developing countries of the world [1].~     According to the WHO reference criteria, an adult is labeled as anemic, if the blood~     hemoglobin concentration falls below 13.0 g/dL in men or less than 12.0 g/dL in the~     non-pregnant women [2]. Hemoglobin concentrations below the lower limit of normal are a~     common laboratory finding in apparently healthy people in general population all over the~     world [3-5]. Many of these mildly anemic individuals are not investigated sufficiently to~     establish the probable cause of their anemia and thus may end up with morbidity and health~     problems, especially the young women in developing countries [4].~      Only few studies on the use of vitamin E in the correction of anemia have been published and~     hardly any on correction of mild anemia in healthy adults. The objective of this intervention~     study was to investigate the association of vitamin E supplementation with post-supplemental~     blood hemoglobin levels in mildly anemic healthy Pakistani adults.~   "
105894|NCT02181335|"~     To establish that at least one of the two doses of Budesonide, as an ethanolic solution~     inhaled from the Respimat ® inhaler (100 and 200 mcg, 2 puffs bid) for a 12-week study period~     in symptomatic moderate to severe asthmatic patients, gives a therapeutic response, which is~     not inferior to that obtained from the dose of Budesonide inhaled from the Turbohaler ® (200~     mcg, 2 puffs bid) and that the safety profile is at least as good~   "
105895|NCT02181322|"~     Study to assess the effect of food on the pharmacokinetics of meloxicam after a single p.o.~     administration of 22.5 mg meloxicam oral suspension and to investigate dose-proportionality~     over a dosage range of 7.5 mg to 22.5 mg~   "
105896|NCT02181309|"~     Study to investigate dose-proportionality over the dosage range 7.5 mg to 22.5 mg, and to~     assess the effect of food on the pharmacokinetics of meloxicam after a single p.o.~     administration of 22.5 mg meloxicam oral suspension.~   "
105897|NCT02181296|"~     The objective of our study is to compare the degree of phrenic nerve blockade after~     interscalene block using 0.1% ropivacaine or 0.2% ropivacaine. Our hypothesis is that using a~     lower concentration of local anesthetic will result in lesser degree of phrenic nerve block.~     40 patients will be enrolled. Half will receive the block with 0.1% ropivacaine and half with~     0.2% ropivacaine. Phrenic nerve and diaphragm function will be assessed by bedside spirometry~     and ultrasound visualization.~   "
105898|NCT02181283|"~     National Guard members, especially those who have been combat-deployed, are at high risk for~     developing alcohol- and prescription-related drug problems. The use of novel Web-based~     interventions combined with either Web-based boosters or Peer support sessions, may have a~     major public health impact for the National Guard by reducing hazardous use of alcohol of~     prescription drugs. The aims of the study are to develop, refine and test tailored~     motivational Brief Interventions (BIs) with varied continuing booster reinforcements (Web vs.~     Peer) and to conduct a randomized controlled trial comparing the efficacy of these BIs (W+W;~     W+P) to usual care on subsequent alcohol/drug consumption and consequences, including injury,~     mental and physical-health functioning, and HIV risk behaviors at 4-, 8-, and 12-months~     post-enrollment.~   "
105899|NCT02181270|"~     Individuals with obesity and particular type 2 diabetes have abnormally high levels of fat in~     liver cells and are at increased risk for cardiovascular and liver-related mortality. Prior~     research has shown that caloric restriction, exercise, and behavior modification can help~     lower hepatic fat levels in these individuals. Additional research has also shown that~     exercise independent of weight loss can reduce hepatic fat content in obese humans. The~     current exercise guidelines do not specify what type or what intensity of exercise is~     required to induce such reductions in hepatic fat. Thus, the purpose for doing this study is~     to determine if there are differential effects on liver fat with 4 wk of high intensity~     intermittent exercise compared with continuous moderate exercise in obese individuals.~   "
105900|NCT02181257|"~     The purpose of this study is to determine if Extracorporeal Photopheresis (ECP) is effective~     in the treatment of progressive Bronchiolitis Obliterans Syndrome (BOS) in patients after~     lung transplantation. Lung transplantation has become the treatment of choice for selected~     patients with end-stage lung disease. However, long-term survival after transplantation~     remains disappointing. Chronic rejection (bronchiolitis obliterans syndrome [BOS]) has~     emerged as the leading obstacle to better long-term outcomes, and represents the leading~     cause of death beyond the first year after transplantation. BOS is diagnosed by the decline~     in the FEV1 measurement from a pulmonary function test. The management of BOS has been~     disappointing. In general, BOS is treated by intensifying the immunosuppressive regimen.~     Despite treatment, most patients continue to show progressive decline in lung function~     resulting in worsening functional status, quality of life, and ultimately graft failure and~     death.~      Extracorporeal Photopheresis (ECP) has been used as a salvage treatment for progressive BOS~     with favorable clinical results in many cases showing patient improvement. On May 2, 2012,~     the Center for Medicare Services issued a decision memo statin the ECP is covered for~     Medicare beneficiaries for the treatment of BOS following lung allograft transplantation only~     wehn the procedure is provided under a clinical research study. It is highly unlikely that~     providers that currently order ECP for their BOS patients who have already failed optimized~     immunosuppressive drug therapy would be willing to randomize half of their patients to~     continue on their failed drug therapy.What is not well understood at this time, however, is~     whether certain coexisting disease states or patient-related demographic, functional,~     treatment-related or diagnostic variables might prove to have predictive value in identifying~     subsets of BOS patients that are likely, or unlikely, to experience reduced rate of decline~     or stabilization in FEV1 following ECP treatment. This is a Registry study to enroll 160~     patients from multiple U.S. centers to (1) confirm that ECP significantly reduces the rate of~     FEV1 decline in BOS patients refractory to standard immunosuppressive drug therapy, and (2)~     capture and assess specified patient demographic, treatment-related, diagnostic, functional~     and co-morbidity- related variables that may predict outcomes after ECP therapy.~   "
105929|NCT02180880|"~     1. Neuropathic pain in spinal cord injured patients~        1. Inclusion criteria~             -  pain intensity, visual analogue scale > 3~             -  a LANSS (Leeds assessment of neuropathic symptoms and signs) score of 12 and above~             -  aged ≥20~        2. Method~             -  Stop pain medications~             -  Test oxcarbazepine (150mg twice daily) and pregabalin (150mg twice daily)~             -  Check pain intensity (VAS score) with Baron's classification~   "
117340|NCT02031627|"~     Proof of principle study in order to determine if there is a difference in treatment effect~     across the 3 study groups when treating lower extremity lymphoedema using a pneumatic~     compression device.~   "
105901|NCT02181244|"~     There is concern in the literature regarding egg consumption in diabetic people. The~     investigators hypothesis is that compared to an oatmeal-based breakfast, an egg-based~     breakfast will not increase the risk for heart disease in diabetic people but it may reduce~     inflammation, in this population characterized by chronic low grade inflammation.~      This is a cross-over study in which subjects will be randomly allocated to consume 1 egg per~     day for breakfast or a bowl of oatmeal with lactose-free milk for 5 weeks. After a 3 wk~     washout period, subjects will be allocated to the alternate treatment for additional 5 weeks.~      Blood will be collected at baseline and at the end of each dietary period to measure plasma~     lipids, glucose, insulin, glycosylated hemoglobin and inflammatory markers.~   "
105902|NCT02181231|"~     The investigators are conducting a research study to learn about the safety and benefit of~     using a medication called buprenorphine for patients with difficult to treat depression. This~     research study is testing whether combining two medications will be effective in treating~     depression when initial treatment with just one antidepressant does not relieve the~     depressive symptoms; this is what is called difficult to treat depression or treatment~     resistant depression. The two medications the investigators are using are: an~     anti-depressant medication called venlafaxine extended release (venlafaxine XR), which is the~     generic form of Effexor, and buprenorphine. Buprenorphine is a medication that is FDA~     approved for the treatment of opioid dependence. The investigators are testing whether adding~     buprenorphine to venlafaxine XR enhances treatment response.~   "
105903|NCT02181218|"~     The purpose of this research study is to find the maximum tolerated dose of a drug called~     romidepsin when given with a treatment regimen called GemOxD. GemOxD is a routine treatment~     for certain types of lymphoma, and involves the administration of three drugs: gemcitabine,~     oxaliplatin, and dexamethasone. In addition to finding the maximum tolerated dose of~     romidepsin, the investigators want to look at the side effects of these drugs when given~     together, as well as how the lymphoma responds to this treatment.~   "
105904|NCT02181205|"~     The investigators are attempting to determine a less invasive method of treatment for~     postdural puncture headaches that can occur after regional anesthesia. The investigators will~     be evaluating the relief of headache with those subjects receiving treatment with a~     sphenopalatine ganglion block with bupivacaine versus placebo, evaluating the incidence of~     epidural blood patch, pain score of headache at 1 hour, then 24, 48, and 72 hours lower with~     post study treatment versus placebo, and potential side effects of those patients receiving~     study therapy as well as epidural blood patch.~   "
105905|NCT02181192|"~     PSA-recurrence prostate carcinoma is associated with two general problems.~        1. Localisation of PSA-recurrence is unconfident. In many cases it's not clear if a local,~          locoregional oder systemic relapse is available.~        2. There is no standard therapy proved by randomised clinical trials. Recommended~          radiotherapy starting with PSA-value < 0.5 ng/ml according to german S3 guidelines is~          based on retrospective data.~      These difficulties may lead to a therapy potentially not adapted to patients situation of~     disease.This study aims to randomised examine if an instant radiotherapy of prostate~     PSA-recurrence (PSA-value between 0.2 - 0.99 ng/ml) or a delayed radiotherapy with additional~     imaging (PSA value >= 1 ng/ml) including PET/CT and bone scintigraphy for reliable~     information about tumor location and expansion is beneficial regarding therapy efficiency,~     quality of life and social economic aspects.~   "
105906|NCT02181179|"~     The primary aim of this research study is to examine the effects of an 8-week yoga program on~     aspects related to nicotine dependence, stress, and coping during a smoking quit attempt.~      Guided by initial studies reporting on the effects of yoga on putative mediators of smoking~     relapse (i.e., cortisol, distress intolerance, withdrawal symptoms), the proposed experiment~     examines the effects of an 8-week yoga practice on nicotine withdrawal intensity by way of~     aiding withdrawal characteristics predictive of smoking relapse. The long-term objectives of~     the proposed line of research are to: (1) inform theoretical models of nicotine withdrawal,~     (2) guide the development of effective alternative interventions for smokers susceptible to~     relapse during the critical withdrawal period (i.e., smokers low in distress tolerance), and~     (3) to help guide behavioral strategies for treating substance addictions broadly.~   "
105907|NCT02181166|"~     Myofascial pain considerably affects women undergoing treatment for breast cancer, is~     characterized by the presence of myofascial taut bands and trigger points. This study aims to~     evaluate the effects of ischemic compression, high-voltage electrical stimulation and~     rehabilitation of kinesio in women with myofascial pain following treatment of breast cancer.~     This is a randomized blind controlled study. For this, we invited 60 volunteers undergoing~     treatment for breast cancer, randomized and allocated into three groups: G1 (cinesioterapia),~     G2 (ischemic compression cinesioterapia +) and G3 (high voltage electrical stimulation~     cinesioterapia +). The stance, the plantar pressure distribution and the balance will be~     assessed by means of photogrammetry and baropodometry respectively. Myofascial trigger points~     will be assessed with the use of infrared thermography, algometry and numerical rating scale~     of pain (END). Moreover, the quality of life of the volunteers will be assessed by the~     Functional Assessment of Cancer Therapy-Breast (FACT-B +4). The volunteers will undergo 10~     sessions of treatment, and reassessed at the end of treatment and after thirty days.~     Normality test is used to verify data distribution and consistent statistical test for proper~     intra and comparisons between groups, being thus considered two factors in the comparisons,~     time and group. A significance level of 5% is assumed.~   "
105930|NCT02180867|"~     This randomized phase II/III trial studies how well pazopanib hydrochloride, combination~     chemotherapy, and radiation therapy work and compares it to radiation therapy alone or in~     combination with pazopanib hydrochloride or combination chemotherapy in treating patients~     with newly diagnosed non-rhabdomyosarcoma soft tissue sarcomas that can be removed by~     surgery. Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in~     chemotherapy, such as ifosfamide and doxorubicin hydrochloride, work in different ways to~     stop the growth of tumor cells, either by killing the cells, by stopping them from dividing,~     or by stopping them from spreading. Pazopanib hydrochloride may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. It is not yet known whether~     radiation therapy works better when given with or without combination chemotherapy and/or~     pazopanib hydrochloride in treating patients with non-rhabdomyosarcoma soft tissue sarcomas.~   "
134089|NCT01812174|"~     This study examines the hemodynamic and hemolytic properties of two additional smaller size~     valves to the On-X line of valves already approved by FDA.~   "
105908|NCT02181153|"~     Although the precise etiology of inflammatory bowel disease (IBD) is still unknown, over the~     last decade active research allowed to gain more precise insights in the pathophysiology of~     IBD indicating that the chronic inflammation of the intestinal mucosa is directed against the~     microbiota of the gut in particularly susceptible individuals. Genetic studies and more~     recently genome-wide association studies (GWAS) have allowed to identify over 70~     susceptibility genes which confer an increased risk of developing IBD. In the last years the~     attention of researchers has shifted to the identification of the early immunological changes~     that occur already at a preclinical stage of the disease, trying also at identifying the~     disease before it shows itself. Recently, the ability of a combination of serological markers~     in predicting the development of IBD has been demonstrated in adults. However, there are no~     studies evaluating a cohort of children at high risk for the disease, in whom the first~     immunological changes underlying the development of IBD could be studied, including a~     combination of genetic, serological, fecal and clinical markers.~      The purpose of this study is to evaluate in a population genetically well-characterized, as~     siblings and twins of patients affected with IBD, early genetic, serologic, fecal and~     clinical markers of disease, which may be present even years before developing the disease.~     The identification of these markers in predisposed individuals could help to implement~     strategies for prevention or early treatment to modify the natural history of IBD.~   "
105909|NCT02181140|"~     The study is designed to evaluate the diagnostic accuracy of a new designed endoscopic~     ultrasonography (EUS) Core biopsy aspiration needle in comparison to a conventional EUS~     aspiration needle in GI-tumors.~   "
105910|NCT02181127|"~     This study will test the hypothesis that a wearable automated bionic pancreas system that~     automatically delivers glucagon only can prevent or treat hypoglycemia vs. usual care for~     people with type 1 diabetes > 21 years old.~   "
105911|NCT02181114|"~     Because of the deceased donor organ shortage, more kidney patients are considering whether to~     receive kidneys from family and friends, a process called living donor kidney transplantation~     (LDKT). Although Blacks are 3.4 times more likely to develop end stage renal disease, they~     are less likely to receive LDKTs. To address this disparity, this randomized controlled trial~     will assess whether Black and White transplant patients' knowledge and receipt of LDKTs can~     be increased when they receive access to the Your Path to Transplant computerized Expert~     System (YPT). This trial will also examine how other known patient, family, and healthcare~     system barriers to LDKT impact YPT's effectiveness.~      Nine hundred (900) Black,White and Hispanic ESRD patients presenting for transplant medical~     evaluation at University of California-Los Angeles Kidney and Pancreas Transplant Program~     (UCLA-KPTP) in Los Angeles, California will be stratified by race and randomly assigned to~     one of two education conditions (YPT vs. Usual Care Education). As they undergo transplant~     evaluation, patients in the YPT condition will receive individually-tailored feedback~     reports, coaching, and socioeconomic resource guidance associated with reducing barriers to~     access to LDKT. Control patients will receive usual care transplant education provided by~     UCLA-KPTP. Changes in knowledge, readiness to pursue LDKT, pros/cons to LDKT, and~     self-efficacy will be assessed at four time points: prior to presenting at the transplant~     center (baseline), during transplant evaluation (approximately 2 months post-baseline), and~     4- and 8-months post-baseline. Completion of transplant evaluation and receipt of LDKTs will~     be assessed 18-months post-baseline.~      At the conclusion of the study, we will have developed an innovative and cost-effective YPT~     Computerized Expert System that could be utilized to tailor LDKT discussion and education in~     different medical settings based on the needs of individual patients of different races.~   "
105912|NCT02181101|"~     This is an open-label, multicenter, 2x2 factorial design, randomized controlled, Phase III~     study comparing the disease free survival after randomisation in patients treated with 3~     cycles of Epirubicin-Fluorouracil-Cyclophosphamide(FEC)-chemotherapy, followed by 3 cycles of~     Docetaxel(Doc)-chemotherapy versus 3 cycles of Epirubicin-Fluorouracil-Cyclophosphamide(FEC),~     followed by 3 cycles of Gemcitabine-Docetaxel(DocGemzar)-chemotherapy, and to compare the~     disease free survival after randomisation in patients treated with 2 years of Zoledronate~     versus 5 years of Zoledronate in patients with early primary breast cancer. Patients will be~     required to have histopathological proof of axillary lymph node metastases (pN1-3) or high~     risk node negative, defined as: 'pT≥2 or histopathological grade 3, or age ≤ 35 or negative~     hormone receptor', but are not allowed to have evidence of distant disease. Patients will~     have to be entered into the study no later than 6 weeks after complete resection of the~     primary tumor. No other antineoplastic treatment other than surgical treatment, the defined~     cytotoxic and endocrine treatment and radiotherapy will be allowed prior to study entry and~     during the course of the study.~      After surgery, leading to R0 resection of the invasive and intraductal components of the~     primary tumor, patients will be randomized to one of the following treatments:~      First randomization~      AA: 3 cycles of 5-Fluorouracil 500 mg/m² i.v. body surface area and Epirubicin 100 mg/m² i.v.~     and Cyclophosphamide 500 mg/m² i.v., (FEC100), each administered on day 1, repeated on day~     22, subsequently followed by 3 cycles of Docetaxel 75 mg/m² body surface area i.v. (Doc), and~     Gemcitabine 1000 mg/m² i.v. (30 min infusion) (Gemzar), administered on day 1, followed by~     Gemcitabine 1000 mg/m² i.v. (30 min infusion) on day 8, repeated on day 22~      AB: 3 cycles of 5-Fluorouracil 500 mg/m² i.v. body surface area and Epirubicin 100 mg/m² i.v.~     and Cyclophosphamide 500 mg/m² i.v., (FEC100), each administered on day 1, repeated on day~     22, subsequently followed by 3 cycles of Docetaxel 100 mg/m² body surface area i.v. (Doc),~     administered on day 1, repeated on day 22~      Second randomization B~      BA: Zoledronic acid 4 mg i.v., every 3 months for the duration of two years, subsequently~     followed by zoledronic acid 4 mg i.v., every 6 months for the duration of additional three~     years~      BB: Zoledronic acid 4 mg i.v., every 3 months for the duration of two years~      During the zoledronic acid treatment period, patients will receive 500 mg Calcium p.o. qid~     and 400 i.E. Vitamin D p.o. qid.~      Patients with positive hormone receptor status (≥ 10 % positively stained cells for estrogen~     and/or progesterone) of the primary tumor will receive Tamoxifen treatment 20 mg p.o. per day~     for 2 years, after the end of chemotherapy. Subsequent to chemotherapy, postmenopausal~     patients with positive hormone receptor status will be treated with Anastrozole (Arimidex®) 1~     mg p.o. for additional 3 years, premenopausal patients will continue Tamoxifen treatment for~     additional 3 years. In addition to tamoxifen, all patients with positive hormone receptor~     status of the primary tumor and under the age of 40 or restart of menstrual bleeding within 6~     months after the completion of cytostatic treatment or with premenopausal hormone levels as~     defined below will receive Goserelin (Zoladex®) 3.6 mg subcutaneously every 4 weeks over a~     period of 2 years following chemotherapy. Premenopausal endocrine status will be assumed, if~     the following serum levels are met: Luteinizing hormone (LH) < 20 mIE/ml, follicle~     stimulating hormone (FSH) < 20 mIE/ml and estradiol (E2) > 20 pg/ml. Endocrine therapy will~     start after the end of chemotherapy.~      All patients with breast conserving therapy or more than 3 axillary lymph node metastases or~     in the following cases after mastectomy:~        -  T3/T4-carcinoma~        -  T2-carcinoma > 3 cm~        -  multicentric tumor growth~        -  lymphangiosis carcinomatosa or vessel involvement~        -  involvement of the pectoralis fascia or a safety margin < 5 mm.~      will receive adjuvant radiotherapy.~   "
105913|NCT02181088|"~     The purpose of this study is to assess two new malaria vaccines, ChAd63 RH5 and MVA RH5, at~     different doses and alone or in combination. The study will enable us to assess the safety of~     the vaccines and the extent of the immune response in healthy volunteers. We will do this by~     giving volunteers one or two vaccinations, doing blood tests and collecting information about~     any symptoms that occur after vaccination. This is the first trial to use these vaccines in~     humans.~   "
105914|NCT02181075|"~     This proof of concept study proposes targeted delivery of a broad-spectrum cytotoxic agent~     (doxorubicin), via a specially formulated LTSL (ThermoDox®) activated by mild hyperthermia,~     by using focused ultrasound (FUS), to achieve enhanced intra-tumoural doxorubicin~     concentrations for the same systemic dose.~   "
105915|NCT02181062|"~     Stroke is a cruel disease that disproportionately kills and disables African-Americans,~     Latinos, Chinese-Americans and Korean-Americans; seniors with high blood pressure are at~     particularly high risk. There is a higher incidence of hemorrhagic stroke in African~     Americans, Latinos, and Chinese Americans relative to non-Latino whites. Asian-Americans have~     up to 1.4 higher relative risk of stroke death compared to U.S. non-Latino whites. A critical~     need therefore exists for a sustainable and scalable mechanism to disseminate~     culturally-tailored stroke knowledge/prevention education in community-based settings where~     large numbers of these high-risk ethnic minority older adult groups are regularly served,~     such as in federally funded Multipurpose Senior Centers (MPCs) that exist across the nation~     (16 of which are in Los Angeles alone).~      The overall objective of the proposed study is to develop and test the implementation of a~     training program for case managers at senior centers to implement a stoke~     knowledge/prevention education program among four high-risk ethnic minority older adult~     groups--Korean-American, Chinese-American, African-American, Latinos. We propose to develop a~     culturally-tailored case manager training curriculum, implement the training at 4~     community-based sites, and evaluate the training model using a randomized wait-list~     controlled trial (n=244) testing the hypothesis that training case managers will decrease~     older adult participants' stroke risk in a sustainable fashion through increasing their~     preventative behavior (i.e. increasing their physical activity--mean steps/day--at 1 and 3~     months).~      Findings will inform similar community-academic partnership efforts around stroke and other~     disease-specific prevention research/interventions; they will also determine next steps in~     terms of whether this case manager-centric model can be scaled up and deployed in other~     community-based settings.~   "
105916|NCT02181049|"~     Due to remarkable advances in childhood cancer therapy the 10-year survival rate increased to~     over 80% and late sequelae come to the fore. Childhood cancer survivors (CCS) suffer from~     significant excess in mortality risk associated with treatment-related complications at least~     for 25 years after the initial cancer diagnosis. In particular, the prevalence of~     cardiovascular disease seems to be elevated compared to the general population. The CVSS~     study is a multi-disciplinary cooperation project between the Institute for Medical~     Biostatistics, Epidemiology and Informatics (IMBEI) and the German Childhood Cancer Registry~     (GCCR), the Preventive Cardiology and Preventive Medicine and the Pediatric Hematology and~     Oncology all at the University Medical Center of the Johannes Gutenberg University Mainz. The~     central element is a thorough clinical cardiovascular examination of all patients, which~     permits detecting subclinical disease. Therapy data will be extracted retrospectively from~     various sources. The study intends to describe the current situation of a cohort of~     approximately 1000 CCS in Germany aged 24 to 49 years with respect to cardiovascular health.~     The role of risk factors (treatment related and classic cardiovascular risk factors), as well~     as related predisposing genetic factors is investigated. The results will contribute to~     recommendations to improve follow-up care.~   "
105917|NCT02181036|"~     To identify the effects of family work shop for children with speech developmental delays.~   "
120967|NCT01984112|"~     The hypothesis of this study is to determine whether the technique of intramedullary locking~     nail presents clinical results comparable to the technique of locking plates, based on the~     Constant Score.~   "
105918|NCT02181023|"~     -  Chronic Obstructive Pulmonary Disease (COPD) is characterized by lung hyperinflation and~          flow limitation. These physiopathological modifications are secondary to loss of elastic~          recoil and bronchial obstruction due to emphysema.~        -  The cornerstone of COPD treatment is represented by inhaled beta-2 agonists and~          anticholinergics. The molecules of the latter classes can be characterized by short~          lasting action (few hours), long acting action (12 hours) or ultra long acting duration~          of action (24 hours).~        -  For years the only anticholinergic (or antimuscarinic) drug other than those used by~          aerosol, was Tiotropium Bromide. Recently two new antimuscarinic agents have been~          launched on the market: glycopyrronium bromide (once daily) and aclidinium (twice~          daily).~        -  The Single Breath Nitrogen Test is capable of identifying the pulmonary closing volume.~          The part of the curve that reflects lung ventilation inhomogeneity is the slope of phase~          III~        -  For COPD patients, the most important characteristic for an inhalatory drug is a prompt~          action in order to give a quick relief from respiratory symptoms, in particular~          dyspnoea.~        -  The objective of this study is to study the acute action of glycopyrronium and~          aclidinium in terms of reduction of hyperinflation, pulmonary specific resistances, lung~          volume distribution and dyspnoea at rest in severe COPD patients.~        -  To our knowledge no study has explored these aspects before.~   "
105919|NCT02181010|"~     The BHCK study will develop, implement, and evaluate a community-based obesity prevention~     program, which operates at multiple levels of an urban food system (policy, wholesaler,~     corner stores, carryout, household, individual; in Baltimore, MD), and will improve the~     healthy food supply chain to increase affordability, availability, purchasing and consumption~     of healthy foods within low-income, minority neighborhoods.~   "
105920|NCT02180997|"~     The purpose of this study is to investigate the pharmacokinetic drug interaction between~     Solifenacin and Tamsulosin in healthy male volunteers.~   "
105921|NCT02180984|"~     The presence of binge eating (BE) is a core feature of bulimic syndromes. Binge eating~     disorder (BED) is a new category in DSM-5 highly associated with higher body mass index~     (BMI). The neural mechanisms that underlie BE are of great interest in order to improve~     treatment interventions. Brain mechanisms underlying drug and food craving are suggested to~     be similar. These mechanisms demonstrated hyperactivity in the orbitofrontal and anterior~     cingulate cortex and lack of regulatory influence from lateral prefrontal circuits. Several~     novel studies began to assess the potential benefits of brain stimulation in reducing craving~     and associated addictive behaviors with promising results. Previous findings testing a~     one-off session of repetitive transcranial magnetic stimulation (rTMS) in healthy women~     identified as strong cravers and individuals with bulimia nervosa or bulimic-type eating~     disorders reported reduction of food craving and BE, providing evidence to support a broader~     and deeper investigation of the benefits associated with rTMS. Importantly, the use of brain~     imaging studies contributes to the understanding of psychiatric disorders and underlying~     mechanisms being target by the rTMS intervention.~      Objectives: The primary aim is to investigate the effects of rTMS over BE frequency.~     Secondary aims include the evaluation of the effects of rTMS on food craving, body weight,~     brain activity, cognition, general psychopathology, hormonal regulation and neurobiological~     markers. Methods: Sixty obese females with BED will be randomized to receive 20 sessions of~     rTMS (n=30) or placebo (n=30) scattered 3 days/week.~      Expected Results: Primarily it is expected that rTMS intervention will decrease BE frequency.~     Consequently, body weight will be reduced. It is also expected that food craving be~     decreased, cognitive performance be enhanced, and neurobiological markers be improved.~   "
105922|NCT02180971|"~     The purpose of this study is to compare the extent of coronary vessel stenosis between~     coronary spasm-induced angina attacks (named vasospastic angina, VSA) patients and health~     volunteers by multi-detector computed tomography angiography (MDCTA), and to evaluate the~     diagnostic efficacy of MDCTA in patients with VSA.~   "
105923|NCT02180958|"~     To assess safety and efficacy of ONYX treatment for cAVM:~   "
105924|NCT02180945|"~     The objective of this study is to evaluate the safety and performance post last embolization~     with Onyx~   "
105925|NCT02180932|"~     The treatment of otolaryngology (OLR) cancer is based on surgery, radiation, sometimes used~     in combination with chemotherapy. Patients treated with radiotherapy have multiple oral~     diseases: mucositis, hyposalivation, tissue fibrosis, exacerbation of periodontitis. Over 70%~     of patients with head and neck cancers treated with radiotherapy have a lower level of dental~     clinical attachment and 92% have loose teeth or missing. The management of these oral~     complications is a priority in OLR oncology. The aim is to improve the oral health of~     patients to achieve a comfortable life acceptable and necessary for healing.~      This project proposes to deepen the investigation with two main objectives:~        1. To study in vivo the effect of radiation treatment on the evolution of the viral flora~          of the periodontium in a cohort of patients and matched controls.~        2. To study in vitro the effects of irradiation on the replication EBV (herpesvirus) in~          producing websites lymphoepithelial tonsillar, and atypical dendritic cells associated~          with EBV that existence were recently discovered.~   "
105926|NCT02180919|"~     The aims of the study are to:~        1. Implement a telemonitoring programme in heart failure and obstructive pulmonary disease~          (COPD) /chronic respiratory patients by assessing the real world impact of on~          readmissions, consults, home visits, quality of life and economic endpoints.~        2. Explore the effects of telemonitoring across heart and respiratory groups with respect~          to i) factors that influence how patients integrate telemonitoring into their daily~          routines and self care behaviour and ii) how healthcare professionals use telemonitoring~          to aid decision- making.~        3. Understand the impact of telemonitoring on a variety of care pathways.~   "
105927|NCT02180906|"~     The purpose of this study is to investigate the immune response in patients with necrotizing~     soft tissue infections (NSTI). The investigation will focus on inflammatory and vasoactive~     biomarkers as prognostic markers of severity and mortality at admission to Rigshospitalet and~     the following 3 days~   "
105928|NCT02180893|"~     Pain after robotic cardiac surgery is a known problem and is often difficult to manage.~     Paravertebral nerve blocks are a proven method of pain relief following thoracotomy. A~     paravertebral block has been shown to provide good pain relief with minimal side effects,~     however, paravertebral blocks for robotic surgery have not been well studied. Currently the~     investigators routinely perform PVB on this patient population (of 50 MV robotic cases done~     between January and October 2012, 36 received paravertebral blocks with no adverse events~     noted). The investigators believe this should be studied further and that paravertebral~     blocks will reduce the amount of additional pain medication patients require in the first 24~     hours after surgery, decrease intubation time and improve PACU and hospital discharge times.~   "
105949|NCT02180620|"~     With many medications we prescribe them relative to time of day or a meal. This study~     established if pre dinner vs post dinner exercise was more effective at altering post dinner~     glucose and triglyceride levels vs no exercise at all.~   "
105931|NCT02180854|"~     Acute deterioration among hospitalised patient can result in serious adverse events like~     cardiac arrest, unexpected death or unanticipated intensive care unit (ICU) admission. Most~     events are preceeded by deteriorating vital signs, and potentially avoidable.~      To detect and treat hospitalised at-risk patients early an early warning score (EWS) was~     introduced at the investigator site. EWS measures of a number of physiological parameters~     that are aggregated to a common score, that directs monitoring frequency, clinical~     interventions and competency of the provider.~      Patients with low scores (0 - 1) are monitored every 12th hour and seldom experience serious~     adverse events. The optimal monitoring frequency for this group is unknown, and presently~     based on a compromise between patient safety and work load issues.~      The aim of the present study is to explore if an 8 hourly monitoring interval (intervention)~     is correlated with a better outcome than 12 hour intervals (control), based on the number of~     patients that deteriorate to a higher EWS 24 hours after hospital admission in each group.~   "
105932|NCT02180841|"~     The purpose of the proposed pilot study is to evaluate the effects of a soy protein isolate~     with naturally occurring isoflavones on the properties of HDL-C (total HDL-C, HDL particle~     size and HDL function), central blood pressure, and indices of arterial stiffness.~   "
105933|NCT02180828|"~     The study is focused to prove that the efficacy and safety of Clotrimazole vaginal tablet vs~     Fluconazole for the treatment of severe vulvovaginal candidiasis~   "
105934|NCT02180815|"~     The purpose of this post-market observational study is to assess the effectiveness and~     patient perception of benefit of the ReVENT Sleep Apnea System in patients diagnosed with~     Obstructive Sleep Apnea due to primary tongue base closure. The ReVENT Sleep Apnea System is~     a minimally invasive surgical approach to treat Obstructive Sleep Apnea. The ReVENT Sleep~     Apnea System consists of an implanter kit and tongue implants. The implants are permanently~     implanted in the tongue during a minimally invasive outpatient surgical procedure to prevent~     tongue base closure during sleep.~   "
105935|NCT02180802|"~     Motivational interviewing (MI) has been shown to be an effective strategy in targeting~     obesity in adolescents and parental involvement has been associated with increased~     effectiveness. The aim of the study is to evaluate and compare the role of parental~     involvement in MI interventions for obese adolescents~   "
105936|NCT02180789|"~     This is an open-label, single-arm, prospective interventional study to assess the~     tolerability and efficacy of Harnalidge® OCAS® 0.4 mg in Taiwan patients who are unsatisfied~     with tamsulosin 0.2 mg for the treatment of lower urinary tract symptoms (LUTS) associated~     with benign prostatic hyperplasia (BPH).~   "
105937|NCT02180776|"~     The objective of this study is to evaluate clinical effectiveness and the effect on quality~     of life of an inelastic thoracolumbarasacral orthosis in male and female hyperkyphotic~     patients with moderate to severe back pain disability and to demonstrate the safety of the~     intervention through detailed reporting and analysis of adverse events.~   "
105938|NCT02180763|"~     The purpose of this study is to compare satisfaction (LQI questionnaire, factor I: treatment~     interference) in PID patients receiving subcutaneous injections of Gammanorm® 165 mg/mL~     according to the delivery device.~   "
105939|NCT02180750|"~     Memory Work Therapy (MWT) has been developed to improve psycho-social outcomes for children~     living with HIV who are orphaned. This phase 2 trial aims to determine whether attending the~     intervention improves outcomes compared to standard care. We aim to test the hypothesis that~     attendance at MWT improves psychological symptoms, self-esteem, emotional and behavioural~     difficulties, and self-efficacy compared to standard care.~   "
105940|NCT02180737|"~     Evaluation of the role of dexmedetomidine as a sole agent in sedating patients undergoing~     interventional radiological procedures and measuring its different outcome variables.~   "
105941|NCT02180724|"~     This study is evaluating the safety and efficacy of acalabrutinib for the treatment of~     subjects with Waldenström Macroglobulinemia (WM)~   "
105942|NCT02180711|"~     To characterize the safety profile of acalabrutinib alone or in combination with rituximab in~     subjects with Indolent B-cell Non-Hodgkin Lymphoma~   "
105943|NCT02180698|"~     This pilot phase I clinical trial studies the side effects and best dose of toll-like~     receptor 4 (TLR4) agonist glucopyranosyl lipid A (GLA)-stable-emulsion (SE) when given~     together with radiation therapy in treating patients with soft tissue sarcoma that has spread~     to other parts of the body (metastatic) or cannot be removed by surgery (unresectable). TLR4~     agonist GLA-SE may stimulate the immune system to kill sarcoma cells. Radiation therapy uses~     high energy x rays to kill tumor cells. Giving TLR4 agonist GLA-SE with radiation therapy may~     be a better treatment to treat sarcoma that cannot be removed by surgery.~   "
105944|NCT02180685|"~     The purpose of this present study is to determine which surgery technic provides the best~     clinical outcome after medial patellofemoral ligament reconstruction comparing suture anchors~     and screw fixation in medial femoral condyle.~   "
105945|NCT02180672|"~     This double-blind, randomized controlled trial will evaluate the use of nasal corticosteroids~     for the treatment of the childhood obstructive sleep apnea syndrome (OSAS). Efficacy,~     duration of action and side-effects will be determined.~   "
105946|NCT02180659|"~     The primary objective of the study is to demonstrate maintenance of treatment efficacy when~     transferring adult outpatients with opioid dependence, who are clinically stabilized on 8 mg~     or less of sublingual (SL) buprenorphine (BPN), to 4 Probuphine implants compared to SL BPN.~      The secondary objective of the study is to confirm safety of 4 Probuphine implants in adult~     outpatients with opioid dependence who are clinically stabilized on 8 mg or less of SL BPN.~   "
105947|NCT02180646|"~     This study examined the effect of a high protein or high carbohydrate breakfast on the~     glucose and insulin response following the breakfast meal, as well as the subsequent response~     following the lunch meal.~   "
105948|NCT02180633|"~     A macular hole is a rupture in the macula. In terms of pathogenesis, as much as 80% are~     idiopathic (Idiopathic Macular Hole, IMH). The normal incidence of this condition is about~     0.17%; however, there is a 10-29% chance of development of a macular hole in the fellow eye~     of patients suffering from unilateral macular hole.~      Our hypothesis is that embedded in the topography of the retina is information that can allow~     for discrimination between healthy eyes and eyes with an increased risk of developing IMH. As~     such, our work aims to develop a system that allows the automatic identification of these~     eyes.~   "
105950|NCT02180607|"~     The overall goal of the proposed project is to investigate the neuronal pathways regulating~     the effects of social acceptance and rejection in healthy controls and patients with Major~     Depressive Disorder (MDD). Social acceptance and rejection are defined as the explicit~     declaration that an individual is liked or not liked. Social acceptance can boost one's~     self-esteem and mood, whereas rejection can lower them. The neurological relationship between~     social acceptance/rejection and depressive symptoms is not known. Using functional magnetic~     resonance imaging (fMRI), it is hypothesized that social feedback will activate a specific~     interconnected neuronal pathway involved in social separation and reward. Executive~     functioning and response to monetary reward will also be assessed during fMRI using two~     additional tasks (monetary incentive delay, parametric go no-go) to determine how these~     cognitive brain functions regulate responses to social feedback.~   "
105951|NCT02180581|"~     The aim of the intervention is to examine the effect of a combination of the two bacterial~     strains BB-12 and LGG, provided for 6 month, on the prevalence of infections and allergic~     manifestations in small children, and how a combination of BB-12 and LGG affects the immune~     system, gastrointestinal tract and the microbiota. Children are enrolled during 2 winter~     seasons.~   "
105952|NCT02180568|"~     The study object is to demonstrate the usefulness and safety of lipiodol localization~     technique for individuals undergoing ground-glass opacity (GGO) Video-assisted thoracic~     surgery (VATS) resection compared to hook wire localization technique. A total of 250~     participants will be enrolled in a 1:1 fashion to Lipiodol or Hook-wire groups. If the aims~     of this study are achieved, the use of lipiodol localization technique will be widespread~     their application for localization of non-palpable pulmonary lesions that are indicated for~     VATS resection.~   "
105953|NCT02180555|"~     Stress hyperglycaemia is commonly observed during hospitalization in the intensive care unit~     (ICU) and has been shown to adversely influence outcome. It has been hypothesized that, when~     it occurs in previously non-diabetic patients, it reflects a latent disturbance of the~     glucose metabolism. Assessing the incidence of this phenomenon and identifying its risk~     factors could support prevention, detection and early treatment of impending diabetes~     mellitus type 2. We will perform a glucose tolerance test approximately 6-9 months post-ICU~     admission to screen for disorders of glucose metabolism. Furthermore, we examined~     characteristics that could have predicted the post-discharge disturbances: patient~     characteristics, parameters of disease severity and of glucose metabolism, as well as the~     FINDRISC (Finnish Diabetes Risc Score). We plan to enroll 400 patients.~   "
105954|NCT02180542|"~     The purpose of this study is to improve secondary prevention of ischemic stroke patients by~        1. Estimating prevalence and the prognostic significance of frequent premature atrial~          complexes in ischemic stroke patients in relation to death, recurrent stroke and atrial~          fibrillation.~        2. Characterize ischemic stroke patients by~             1. Echocardiographic characteristics~             2. Biochemical markers~             3. Plaque composition in the carotid arteries~                  -  in order to improve risk stratification.~   "
105955|NCT02180529|"~     Background: The increase in life expectancy and the rise in the ratio of older to younger~     people in the population has resulted in an increase in the number of those suffering from a~     decrease in cognitive ability, such as Mild Cognitive Impairment (MCI). Methylphenidate can~     improve cognitive ability, mainly in memory and executive function.~      Working hypothesis and aims:~      This study examines the effect of Ritalin treatment in older people suffering from MCI. Our~     hypothesis is that treatment with Ritalin will improve cognitive function in those suffering~     from MCI, especially in the domains of attention and executive function.~      Methods A randomized, double-blind, case-control study. 120 patients older than 65 years of~     age diagnosed as suffering from MCI in the past year in geriatric assessment facilities in~     Beersheva. Patients will be randomized in equal groups to either the study group (Ritalin~     treatment) and control group (placebo). Each participant will attend the geriatric unit for~     four consecutive days: on the day prior to beginning the intervention participants will~     undergo cognitive assessment at 9:00 am. On the intervention days (days 2-4) participants~     will undergo cognitive assessment at 9:00 in the morning, followed by the administration (at~     10:30) of different doses of Ritalin (10, 20 and 30mg) every day of intervention.~     Participants in the control group will receive placebo. Two hours after taking the drug or~     placebo participants in both groups will be assessed cognitively by means of Mindstreams and~     MoCA (Montreal Cognitive Assessment).~      Expected results: Ritalin treatment will improve the cognitive function of the subjects,~     mainly in the domains of concentration and executive function~   "
105956|NCT02180516|"~     Study to assess the safety profile of meloxicam by comparing incidence of gastrointestinal~     adverse events of meloxicam with that of NSAID in the routine daily therapeutic situation.~   "
105957|NCT02180503|"~     Investigation of the relative bioavailability of 1 mg and 10 mg BI 1356 BS as PIB~     reconstituted with 0.1% tartaric acid vs. 1 mg and 10 mg BI 1356 BS as tablet including a~     food effect for the 10 mg tablet dose group~   "
105958|NCT02180490|"~     Study to investigate the bioequivalence between 10 mg tablets (test drug) and 10 mg capsules~     (reference drug) of meloxicam (UHAC 62 XX) in fasted state.~   "
105959|NCT02180477|"~     Study to investigate the relative bioavailability of UHAC 62 XX capsule and two different~     tablet formulations (TF1 and TF2), and to obtain data for rational design of a subsequent~     pivotal bioequivalence (BE) study between capsule and tablet formulations.~   "
105960|NCT02180464|"~     Proof-of concept study to competitively investigate antipsoriatic efficacy and safety of a~     LAS41004 formulation vs active control No formal study hypothesis, but descriptive evaluation~     (PoC).~   "
105961|NCT02180451|"~     The purpose of this study is to characterize the circadian rhythm disruption experienced by~     patients as determined by plasma melatonin, cortisol, and other circadian analytes~   "
105971|NCT02180321|"~     Massive bleeding is expected when performing distraction osteotomy for craniosynostosis~     patients. Since such operation is performed at very young age, many efforts are performed in~     order to reduce the total amount of bleeding and the transfusion during and after the~     surgery. Our study aims at correcting the coagulopathy from massive bleeding and transfusion~     during distraction osteotomy using continuous infusion of antifibrinolytic agent, tranexamic~     acid. Tranexamic acid infusion is determined according to the pharmacokinetic model, and the~     changes in coagulopathy will be defined using thromboelastography.~   "
105962|NCT02180438|"~     There is a critical need for safe and effective antiretroviral treatment (ART) regimens for~     HIV-2 infection. This is especially true in West Africa, where the vast majority of the 1-2~     million individuals infected with HIV-2 live and were access to effective ART for HIV-2 is~     limited. HIV-2 is intrinsically resistant to non-nucleoside reverse transcriptase inhibitors~     (NNRTI) and the fusion inhibitor enfuvirtide (T-20) and mutations conferring broad resistance~     to nucleoside/nucleotide reverse transcriptase inhibitors (NRTI) are frequently observed in~     HIV-2 from patients receiving ART. Although antiretroviral protease inhibitors (PI) can be~     used effectively to treat HIV- 2, HIV-1 and HIV-2 also exhibit important differences in their~     susceptibilities with studies indicating that saquinavir (SQV), lopinavir (LPV), and~     darunavir (DRV) are the only potent PI's against HIV-2 replication and cross-resistance is~     frequent. Although an increasing body of evidence supports the potential utility of integrase~     inhibitors (INI) against HIV-2, there have been no clinical trials to assess their~     effectiveness and they are not routinely available in resource-limited settings. These~     limitations present major challenges to HIV-2 treatment, particularly in the areas in which~     it is most prevalent. This study is the 1st use of STRIBILD (elvitegravir (EVG), cobicistat~     (COBI), emtricitabine (FTC), tenofovir disoproxil fumarate (TDF)), an INI-based single tablet~     regimen, in HIV-2 infected adults in West Africa. The investigators hypothesize STRIBILD will~     be safe and effective as ART for HIV-2 infection. The Specific Aims of this study are: AIM 1:~     A pilot, open label, 48 week trial of STRIBILD (elvitegravir, cobicistat, emtricitabine,~     tenofovir disoproxil fumarate) in 30 ARV-naïve HIV-2 Infected Adults in Dakar, Senegal. AIM~     2: Determination of genotypic and phenotypic HIV-2 antiretroviral resistance in individuals~     with virologic failure (HIV-2 plasma RNA >250 copies/ml) participating in the 48 week trial~     of STRIBILD~   "
105963|NCT02180425|"~     The purpose of this study is to evaluate the differences in the skin lipid profile of~     patients with and without acne. Secondly, the goal is to learn more about what the effects of~     retinoinds (topical and systemic) are on the the skin lipid profile. We hypothesize that the~     skin lipid profile of subjects with acne will be lower in inflammatory lipids in comparison~     to subjects without acne.~   "
105964|NCT02180412|"~     This study aims to provide high quality evidence for the effectiveness and safety of hemin~     (PanhematinTM , Recordati) for treatment of acute attacks of porphyria. These types of~     studies have not been done before with either PanhematinTM or the hemin preparation available~     in Europe (NormosangTM, Orphan Europe).~      There are two treatment groups in this study. One group will be treated with PanhematinTM~     plus glucose, and the other group will be treated with glucose plus an inactive salt solution~     (called a placebo). To avoid prejudice, the treatment given to each participant will be~     blinded (meaning the participants and most of the hospital staff will not know which~     treatment the participant will receive) and randomized (meaning participants will have an~     equal chance of receiving either treatment, like the flip of a coin). A placebo-controlled,~     randomized study is the standard method used to prove treatments are effective and safe.~     PanhematinTM and glucose will be given in the same manner as is usual for treating an attack~     of porphyria. For participants who are chosen to receive the placebo, their treatment will be~     switched to real PanhematinTM at any time if their symptoms do not improve. This is called~     rescue treatment, and assures that they study is safe and patients who need hemin will~     receive it. Treatment with hemin will be for 4 days, or longer if needed. Since the study~     treatment is started as soon as possible after symptoms appear, there will be very little~     delay in providing hemin to those who need it. Funding Source - Office of Orphan Products~     Development (FDA OOPD)~   "
105965|NCT02180399|"~     Determination of capillary lactate by using point-of-care technique is accessible, fast and~     allows to quantify the circulatory and metabolic dysfunction caused by sepsis. Compared to~     conventional assay techniques in arterial blood, capillary assay technique may have an~     increased susceptibility to metabolic alterations induced by sepsis in its initial stages.~     This increased sensitivity is not necessarily relevant in the management of the most serious~     patients for whom the diagnosis is obvious, but it could be very useful in patients for whom~     a diagnosis of severe sepsis or shock have not yet been adopted, particularly to help better~     identify patients who would require intensive management and avoid the installation of these~     serious disorders.~   "
105966|NCT02180386|"~     The aim of the study was to assess whether the behavior, anxiety, and dental pain of~     pediatric patients during dental treatment improves when a video game is played as method of~     distraction.~   "
105967|NCT02180373|"~     The overall goal of this multicenter collaborative research study is to identify genetic,~     proteomic, and/or lipidic (lipidomic) biomarkers associated with the outcomes of lower~     extremity revascularization in patients with advanced peripheral artery disease (PAD).~   "
105968|NCT02180360|"~     Background: Nowadays, a commonly used sport that helps enhancing physical fitness components,~     including flexibility, is Capoeira. This modality is defined as an athletic sport composed by~     an individual attack and defensive system, which was originally created in colonial Brazil.~     Capoeira is characterized by its main movement, the ginga, and by other several dodging,~     unbalancing, traumatizing and acrobatic movements. The literature empirically discusses that~     Capoeira contributes in general physical fitness by modulating several variables of human~     movement. Among these variables it is possible to highlight the influence of Capoeira in the~     amplitude of movement of the practitioner's joints. However, no study with a control group~     has investigated the alterations in flexibility of beginners using an experimental protocol~     based exclusively in basic techniques of Capoeira, without applying any usual stretching~     exercises that are commonly used, independently of the specificity of the sport. Objective:~     To analyze the effects of eight weeks of basic training in Capoeira on the flexibility of~     beginners in the sport. Methods: Twenty-one individuals, divided in two groups [Capoeira,~     n=13; 26.1±7.2 years; 22.7±2.7 kg.m2(-1) and Control, n=8; 27.1±0.5 years; 24.3±3.3~     kg.m2(-1)] participated in the study. The Capoeira group performed eight weeks of basic~     training (two sessions per week lasting 60 minutes each). The experimental protocol used was~     exclusively based in basic techniques of a programmed Capoeira training system. Before and~     after the intervention measurements were performed aiming to analyze: trunk flexion~     flexibility, through a sit-and-reach test using a Wells' Bench (WBtf); and passive tension~     (PThf) and maximum amplitude of hip flexion (MAhf) through goniometry. The hypothesis of this~     study is that the group Capoeira (beginners) will increase the linear and angular flexibility~     after eight weeks of basic training in the sport.~   "
105969|NCT02180347|"~     The objective of this study is to determine if multifocal contact lenses affect accommodation~     and/or binocular vision when worn by pediatric patients. This will be accomplished through~     subjective and objective accommodative and binocular experiments in children wearing single~     vision and multifocal soft contact lenses.~   "
105970|NCT02180334|"~     The aim of this study is to investigate the effects of combined administration of mosapride~     as modulator of gastrointestinal motility and DPP-4 inhibitor on secretion of gut hormone~     such as glucagon-like peptide-1 (GLP-1) and gastric inhibitory polypeptide (GIP), and oral~     glucose tolerance. Additionally, change in lipid profile and insulin secretion will be also~     assessed.~   "
105972|NCT02180308|"~     The overarching goal of this study is to develop PET/MR techniques to accurately detect nodal~     metastases for surgical planning and assessment of treatment response.~   "
105974|NCT02180282|"~     Up to 20 healthy subjects age 15-45 years old ,Skin Phototype I-V,Study will be conducted in~     1 site.~      Primary objectives is to evaluate the efficacy of IPL acne filter treatment for improvement~     of acne vulgaris as assessed by lesion count.~   "
105975|NCT02180269|"~     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK,~     study of the way a drug enters and leaves the blood and tissues over time) of~     single-ascending oral doses of JNJ-54861911 in healthy Japanese male participants.~   "
105976|NCT02180256|"~     To examine whether endometrial scratching (or injury) using a Pipelle endometrial sampler,~     performed on the first seven days of the menstrual cycle, is able to improve pregnancy rates~     in women who will be submitted to a fresh embryo transfer.~   "
105977|NCT02180243|"~     The purpose of this study is to explore the effectiveness Gulf War Health Education (GWHE)~     and iRest Yoga Nidra (meditation)/auricular (ear) acupuncture for Veterans with Gulf War~     Veterans' Illnesses (GWVI).~   "
105978|NCT02180230|"~     The aim of this study was to evaluate the 7 mm long implants NobelSpeedy Shorty and Brånemark~     System Mk III Shorty: by determining the marginal bone remodeling, implant survival rate,~     soft tissue health and maintenance.~   "
105979|NCT02180217|"~     The study aims to confirm long-term efficacy and safety of LCI699 for the treatment of~     patients with Cushing's disease. It is a pivotal trial intended to support the registration~     of LCI699 for the treatment of patients with Cushing's disease in the EU, Japan, and other~     countries.~   "
105980|NCT02180204|"~     This is a double-blind parallel arm randomized trial aimed to assess efficacy and safety of~     intravenous Tenecteplase compared to intravenous Alteplase in eligible patients who present~     with symptoms of acute ischemic stroke within 3 to 4.5 hours from onset.~   "
105981|NCT02180191|"~     An altered gut microbiota composition has recently been linked to obesity and diabetes. The~     principal aim of this study was to investigate and compare the gut microbiota composition of~     obese, diabetic and control individuals. Then, associations between analyzed gut microbial~     concentrations and clinical-biochemical blood parameters were assessed.~   "
105982|NCT02180178|"~     Goal of the registry is to collect data on patients undergoing coronary angiography in Mainz.~     Following amendment of the procol, this study will also include patients who received an~     Aborb bioresorbable scaffold for the therapy of de novo stenoses.~   "
105983|NCT02180165|"~     The primary objective of this study is to assess and compare the safety of posaconazole with~     voriconazole in Japanese participants with Aspergillosis.~   "
105984|NCT02180152|"~     The purpose of this study is to verify if postprandial walks are effective in obese pregnant~     women, as regards to gestational weight gain and typical diseases of that period, as~     gestational diabetes and preeclampsia. Perinatal outcomes will be observed, such as~     macrosomia, shoulder dystocia and fetal death.~   "
105985|NCT02180139|"~     Dystonia is a devastating disorder defined by involuntary, sustained muscle contractions or~     abnormal postures that can affect any part of the body. Cervical dystonia (CD) is the most~     pervasive form of dystonia affecting 60-90,000 individuals in the United States alone and is~     characterized by involuntary twisting of the neck. The symptoms of CD are disabling,~     disfiguring, painful, and have a strongly negative impact on quality of life, including~     social withdrawal and depression. At present, there is no treatment that has been shown to~     have long term benefit in CD. Standard of care (SOC) is botulinum toxin, which temporarily~     paralyzes affected muscles, resulting in reduced muscle spasms. This treatment has many~     undesirable side effects, variable effectiveness, is expensive, and must be repeated every 3~     months throughout the lifespan. Physical therapy based treatments aimed at retraining posture~     or stretching dystonic muscles are largely ineffective and not typically delivered as a part~     of standard of care. There is an urgent need for novel and effective therapies. Emerging~     technologies, specifically non-invasive brain stimulation (NBS), have demonstrated compelling~     evidence to make a meaningful impact in the lives of people with CD. In this study,~     individuals with cervical dystonia will be randomly assigned to receive tDCS for 15 minutes~     daily for 4 days in 1 of 4 stimulation location groups.~      Hypothesis 1: One location of stimulation will result in clear benefit with at least 1~     standard deviation (SD) improvement in the CDQ-24, the primary outcome measure, at 1-week~     follow-up.~      Hypothesis 2: The cortical silent period will be the most sensitive measure investigated and~     will demonstrate significant increase in inhibition as determined by an elongation of silent~     period in the affected upper trapezius muscle.~      Hypothesis 3: The stimulation location determined to be most effective in Objective 1 will~     produce the greatest physiologic change in inhibition increase.~      Hypothesis 4: The hypothesis for this aim is if certain characteristics can predict response~     to treatment, a strong association will be seen between baseline measure(s) and the primary~     outcome measure. A thorough assessment of characteristics including: age, sex, duration of~     symptoms, genotyping for two specific polymorphisms, botulinum toxin history, baseline~     measures of outcome variables, measures of brain excitability, and genetic testing will~     predict response.~   "
105986|NCT02180126|"~     A positive Anti-Neutrophil Cytoplasm Antibody (ANCA) test administered to patients with a~     high probability for vasculitis has high sensitivity and specificity for vasculitis. A~     positive ANCA test result in those patients who do not have a high probability for vasculitis~     requires extensive follow-up because those patients eventually present with malignancy or~     other inflammatory diseases. The investigators wish to investigate the correlation between~     the differing levels of positive ANCA tests and their relationship to vasculitis, malignancy~     and inflammatory diseases.~   "
105987|NCT02180113|"~     FibroScan® (Echosens, Paris, France) is an active non implantable medical device marketed in~     Europe since December 2003 and is currently used in many countries. FibroScan® is an~     ultrasound-based vibration-controlled transient elastography (VCTE™) device dedicated to~     liver stiffness measurement (LSM).~      Several clinical studies have shown the accuracy of LSM by FibroScan® to predict liver~     fibrosis.~      Some other studies have already shown the good correlation between LSM, assessed by~     FibroScan® based on VCTE™ technology, and the presence of portal hypertension (PHT).~      PHT is a clinical condition characterized by a high blood pressure in the portal vein and its~     tributaries and it is defined as a gradient between portal and systemic blood pressure > 6~     mmHg.~      The development of oesophageal varices (OV) in cirrhotic patients, as well as their potential~     bleeding, represent one of the most severe and life-threatening complication of cirrhosis.~      Upper endoscopy is the best diagnostic tool for detecting the presence of OV, gastric varices~     or congestive gastropathy, for estimating the grade of OV and for the recognition of the~     presence of red color signs and wale marks or other indicators of high risk for bleeding.~      However these two methods are quite invasive and associated with some risks; at the same~     time, not all cirrhotic patients present OV at endoscopic screening.~      The aim of this study is the validation of SSM, assessed by a FibroScan® with acquisition~     parameters and algorithm optimized for SSM, as surrogate noninvasive marker for the presence~     of OV in liver cirrhosis patients.~   "
105988|NCT02180100|"~     The objectives of this study were to demonstrate comparable safety and efficacy of~     Terconazole Vaginal Suppositories, 80 mg and fluconazole in the treatment of subjects with~     severe vulvovaginal candidiasis.~   "
106022|NCT02179658|"~     The primary objective of this study is to investigate the safety and efficacy of OPT-80~     versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).~   "
105989|NCT02180087|"~     Currently, the management of pain after cardiac surgery is based on the concept of multimodal~     analgesia: Combined use of non-opioid analgesics associated with morphine intravenous~     analgesia by a system controlled by the patient (patient-controlled analgesia-PCA).~      The combination of paracetamol and morphine PCA is very effective on pain at rest, but is~     limited on pain mobilization and causes the problem of side effects associated with opioid~     (overdose, sedation, respiratory depression, gastrointestinal intolerance, urinary retention~     ...) which are contributing factors to increase the length of stay in Intensive Care Unit, an~     additional cost of care and an increase postoperative morbidity and mortality.~      Methods that have proved their effectiveness on pain and mobilization used in postoperative~     cardiac surgery are: anti-inflammatory drugs (NSAIDs) and / or loco-regional analgesia~     techniques. NSAIDs enhance analgesia produced by PCA Morphine and allow a reduction in~     morphine consumption, improved postoperative pain, decreased sedation and decreased~     postoperative morbidity and mortality.~      Adverse effects of NSAIDs are commensurate with their time and exposure dose. Consequently,~     NSAIDs, in the absence of against-indications, should always be prescribed and used at the~     lowest effective dose and for the shortest possible time.~      Some studies have suggested that lower doses of NSAIDs didn't appear to affect their~     effectiveness. At present, the investigators have no studies that address the hypothesis from~     which minimum dose of ketoprofen analgesic effect is obtained.~      The investigators hypothesis is that lower dose ketoprofen may have efficacy on pain in the~     postoperative mobilization of cardiac surgery. The investigators want to find, in their~     study, this optimal ketoprofen dose which would be the minimum dose for clinical efficacy~     demonstrated dose.~      This optimal dose could reduce the number of adverse effects of NSAIDs, but their study will~     probably not have enough power to prove it. NSAID use at these low doses, in postoperative~     cardiac surgery, could be extended to patient populations most at risk or for a duration~     longer than 48 hours.~   "
105990|NCT02180074|"~     Cardiovascular disease which includes coronary artery disease and peripheral artery disease~     remains the leading cause of death among women in the United States. The impact of~     cardiovascular in women was not recognized by clinicians for a long time. It is now evident~     that, women suffer the consequences of cardiovascular at rates at least as high as those~     observed in men but there are still major gaps in our understanding this disease in women.~     Hydrogen sulfide (H2S), a gaseous mediator plays an important role in the cardiovascular~     system. Research has demonstrated it's critical role in animal ischemia reperfusion models.~     Hydrogen sulfide exists in distinct biological pools in blood. Recently, the Kevil lab has~     pioneered the development of new analytical techniques for accurate measurement of all~     biological pools of H2S. By measuring these distinct pools of H2S in women with and without~     cardiovascular disease the investigators hope to further understanding of role of H2S in~     pathophysiology of cardiovascular disease. This research will help to assess the ability of~     H2S and its distinct biological pools to potentially be a diagnostic marker or a therapeutic~     target for cardiovascular disease.~   "
105991|NCT02180061|"~     This study will assess the safety, tolerability, and efficacy of every-3-week dosing (Q3W) of~     pembrolizumab (MK-3475) in participants with advanced melanoma; participants may receive~     pembrolizumab for up to 2 years if deriving clinical benefit. The primary study hypothesis is~     that treatment with single agent pembrolizumab will result in a clinically meaningful overall~     response rate.~   "
105992|NCT02180048|"~     The purpose of this study is to observe effects of caffeine on overactive bladder symptoms~     and wellbeing. This study looks at whether caffeine has bad effects on urinary symptoms or if~     lower doses of caffeine decrease the effects.~      The study will propose the following hypothesis:~        1. The voiding and mental health symptoms will be greatest in the high dose treatment and~          lowest in the placebo treatment.~        2. The low dose treatment will produce more voiding and mental health symptoms than the~          placebo treatment.~        3. Voiding and mental health symptoms will be mediated by hydration status of the patient~          which will be assessed using a Tanita Scale.~   "
105993|NCT02180035|"~     To evaluate if nutritional treatment with nutritional supplementation of dietary fiber~     reduces cholesterol levels and triglycerides (dyslipidemia) in patients with HIV/AIDS~     receiving antiretroviral therapy (HAART).~   "
105994|NCT02180022|"~     Acute or chronic intake of polyphenol-rich foods has been reported to improve endothelial~     function. Quercetin, found abundantly in onion, is a potent antioxidant flavonoid. This study~     was designed to investigate whether consumption of onion peel extract (OPE) improves~     endothelial function in healthy overweight and obese subjects.~   "
105995|NCT02180009|"~     In this study, the investigators will dynamically detect the expression of an immune~     regulator- T cell Ig and mucin domain protein 3 (Tim-3) in patient with sepsis.~   "
105996|NCT02179996|"~     Preterm neonates are fragile to infections. Their immune system is immature, yet in France,~     primary vaccines are injected at two months of age, as in term infants.~      Recommendations for vaccinations in infants have changed in France in 2013, suppressing the~     second injection at three months after birth. Preterm and full-term born infants are now~     vaccinated at two and four months of age, but no data regarding efficacy in very preterm~     infants have been registered.~      The investigators hypothesize that two vaccine injections (at two and four months) would be~     less efficient than three injections (two, three and four months) in very preterm-born~     infants.~   "
105997|NCT02179983|"~     Pulmonary rehabilitation is well established as a treatment in COPD. After exacerbations of~     COPD, rehabilitation is associated with reduced frequency of exacerbations and improved~     exercise capacity. No data are available in bronchiectasis.~      This study will randomly assign patients with bronchiectasis exacerbations to pulmonary~     rehabilitation or standard care. The hypothesis is that exercise capacity will be improved by~     pulmonary rehabilitation at 8 weeks.~   "
105998|NCT02179970|"~     Pancreatic, ovarian and colorectal cancers are difficult to treat using chemotherapy and~     immune therapies.Currently most patients are offered treatment with a standard chemotherapy~     drug depending on their cancer type. Recently, laboratory studies have shown that a drug~     called plerixafor may help the body to overcome resistance to immune therapy.~      The purpose of this study is to find out if the study drug has the same effect on patients~     with advanced pancreatic, ovarian or colorectal cancer, as we have seen in our laboratory~     experiments, and find out the right dose of the study drug to give. This is a 'dose~     escalation study'. Patients will be recruited slowly and the study team will closely monitor~     the effect the drug has, until they find the best dose to give. As part of this study, blood~     and tumour samples will be collected and analysed in our laboratories and the patients cancer~     will be monitored using two imaging techniques, CT and FDG-PET scans.~   "
106023|NCT02179645|"~     A Single Dose Study of GRC 27864 in Healthy Volunteers.~   "
106041|NCT02179411|"~     Autonomic nervous system contributes to the regulation of renal blood flow, affected by~     upright posture. Kidney transplantation implies sympathetic denervation. The aim of this~     study is to compare the renal vascular response in volunteers and renal graft recipients to~     an orthostatic stress induced by a head-up tilt test. Renal peripheral resistances are~     assessed by echo Doppler. The sympathetic nervous system activity is evaluated by plasma~     concentrations of catecholamine before and after the head-up tilt test.~   "
105999|NCT02179957|"~     The identification of abnormal narrowing of a blood vessel from non-invasive coronary~     angiography remains an exciting goal. While Computed Tomography (CT) has established a clear~     role in patients it retains some limitations. Primarily, alterations in blood flow leading to~     a restriction in blood supply to tissues cannot be accurately predicted from the anatomical~     assessment of an abnormal narrowing in a blood vessel - a limitation of both invasive, and~     computed tomographic, angiography. This is important, as there is now a raft of evidence~     demonstrating that revascularisation should only be considered in the presence of a~     restriction in blood supply to tissues.~      The gold standard method of identifying a restriction in blood supply to tissues is~     measurement of the fractional flow reserve (FFR), a dimensionless value generated as a ratio~     between the circulatory pressure before and after a narrowing of a blood vessel.~      At present, patients with indeterminately significant abnormal narrowing in a blood vessel~     identified using CT must go on to have a further test for a restriction in blood supply to~     tissues, prior to any decision about revascularisation being made.~      As part of our governance commitment to maintaining our reporting standards, we undertake~     ongoing audit of our cardiac CT practice. The investigators recently identified a group of~     patients who have undergone FFR measurement as part of routine clinical care, and compared~     these to our clinical reports, to ensure that appropriate recommendations were being made. It~     appeared that the ability to predict important abnormal narrowing in a blood vessel was~     reasonable (~70%) and hence we propose the formulation of a research question to explore this~     further.~      The primary objective of this study is to determine the accuracy of a visual assessment of~     the likely significance on blood flow of a narrowing of a blood vessel identified on cardiac~     CT, in comparison to invasive, fractional flow reserve.~      The secondary objective is to evaluate features of an abnormal narrowing in a blood vessel~     that is likely to have a significant impact on blood flow.~      The investigators' working hypothesis is that cardiac CT FFR is a useful predictor of~     abnormal narrowing in a blood vessel.~   "
106000|NCT02179944|"~     This project will be a prospective physiologic study. We will closely follow 60 medication~     abortion patients with serial repeat serum hCG and urine semi-quantitative hCG testing. We~     plan to recruit patients from two gestational age strata: ≤ 49 days and > 49 days.~      Study Objectives:~        1. To create a nomogram describing the change in serum hCG values in the first five days~          immediately following medication abortion with mifepristone and misoprostol.~          Specifically, we will describe the percent serum hCG decline from Day 1 (day of~          mifepristone) to Day 3 (day after misoprostol), from Day 1 to Day 5, and from Day 1 to~          Day 7-10.~        2. To explore whether there is a significant difference in the rate of hCG decline based on~          initial gestational age determined by ultrasound and initial serum hCG.~        3. To describe the correlation between semi-quantitative urine hCG test results and serum~          hCG values to determine how soon after initiating medication abortion the urine test can~          detect completed abortion.~      We hypothesize that among successful medication abortions, there will be a predictable trend~     with at least a 50% drop by Day 3 and 80% drop by Day 5.~   "
106001|NCT02179931|"~     To establish bioequivalence of flupentixol/melitracen between a new film-coated tablet~     formulation of 0.5 mg flupentixol/10 mg melitracen and the marketed coated tablet formulation~     of 0.5 mg flupentixol/10 mg melitracen (Deanxit®), administered as single doses.~   "
106002|NCT02179918|"~     This is a safety, pharmacokinetic and pharmacodynamic study designed to estimate the maximum~     tolerated dose (MTD), and determine the Recommended Phase 2 Dose (RP2D) of PF-05082566, a~     4-1BB agonist monoclonal antibody (mAb), in combination with MK-3475, a PD-1 inhibitor in~     patients with solid tumors.~   "
106003|NCT02179905|"~     This study is to analyze the relationship between brain structure, the heart rate variability~     and the serum fatty acid component of the irritable bowel syndrome patients.~   "
106004|NCT02179892|"~     The purpose of this study is to compare the efficacy and duration of bupivacaine~     extended-release liposome injection (Exparel) versus bupivacaine with dexamethasone in~     transversus abdominis plane (TAP) blocks for patients undergoing abdominal surgery at Emory~     University Hospital and Emory University Hospital Midtown.~      The investigators hypothesize that Exparel will provide greater postoperative pain relief~     than bupivacaine with dexamethasone. The investigators plan to enroll up to 50 male and~     female subjects meeting inclusion and exclusion criteria who will be randomized to receive~     either Exparel (Group 1) or bupivacaine with epinephrine and dexamethasone (Group 2) in the~     TAP block to achieve at least 22 subjects in each group~   "
106005|NCT02179879|"~     Procedural skills play an important role in anaesthetic expertise. More focused training and~     assessment of procedural skills will be needed in the future as training moves from an~     apprenticeship based training system to competency based assessment.~      Currently various techniques exists to assess procedural skills of anaesthetist. For epidural~     catheter placement, task specific check list, global rating scales and cumulative sum~     techniques have been developed and validated. These techniques aim either for better~     qualitative outcome sacrificing objectivity or rely on self-reporting. A decrease in~     objectivity in turn hampers inter-rater reliability which is an essential component of a~     valid assessment model. Checklists type assessments force the developer to comprehensively~     characterize the procedure of interest and then validate the completed procedure~     characterization. This approach has been quantitatively shown to have higher assessment~     reliability levels compared to Likert-scale assessment.~      The objective of the project is to develop and validate a comprehensive procedure~     characterization for labor epidural catheter placement. Another objective is to compare this~     new assessment tool with existing checklist and global rating scale for labor epidural to~     establish concurrent validity.5 A well-developed objective, validated procedure~     characterization serves as a master tool which has multiple applications. It helps to build a~     training programme for the procedure, allows providing metrics based feedback to trainees~     using simulator, helps to assess the performance of trainees and in future might be used as~     benchmark to allow competency based progression in the training.~   "
106006|NCT02179866|"~     This study is designed to investigate the absorption, distribution, metabolism and~     elimination of a single oral dose of radiolabeled [14C]-labeled RO5285119 in healthy male~     participants.~   "
106007|NCT02179853|"~     Kawasaki disease (KD) is the leading cause of acquired heart disease in children in the~     developed world. Despite available treatment, 25% of children in San Diego County~     appropriately treated for KD develop coronary artery abnormalities that may lead to~     complications later in life, including heart attack. Although the investigators can identify~     children with KD that have these coronary artery abnormalities, there is no approved~     additional treatment to decrease coronary artery inflammation and arrest or prevent damage to~     the coronary arteries. Anakinra, a therapy that blocks the high levels of interleukin 1 (IL1)~     that lead to inflammation during acute KD, has been shown in the KD mouse model to prevent~     the development of coronary artery damage. Therefore, the investigators propose to study the~     safety and activity of anakinra in infants and children < 2 years old with coronary artery~     abnormalities from KD.~   "
106353|NCT02175303|"~     To evaluate safety and efficacy using decidual stromal cell therapy for toxicity and~     inflammation, with special focus on allogeneic hematopoietic cell transplantation patients.~     The hypothesis to be tested is that the cells are safe to infuse and that they have an~     anti-inflammatory and healing effect.~   "
106008|NCT02179840|"~     One of the fundamental goals of anesthesia care is to optimize tissue perfusion and~     oxygenation, especially in critically ill patients. The standard monitors such as blood~     pressure, heart rate and pulse oximetry do not directly reflect tissue information and can be~     misleading sometimes. Coherent hemodynamics spectroscopy (CHS) based on cerebral oximetry is~     proposed as a continuous and non-invasive tool assessing cerebral microvascular hemodynamics.~     The investigators propose this study to explore the validity of CHS via comparison with~     transcranial Doppler measurement in anesthetized surgical patients. The hypotheses are: 1)~     CHS can effectively measure cerebral microvascular hemodynamic changes associated with~     mechanical ventilation adjustment during anesthesia. 2) CHS can assess functional status of~     cerebral autoregulation that is altered by hypercapnia and inhalational anesthetic agent.~   "
106009|NCT02179827|"~     The aim of this study is to assess the responsiveness of the standard minimally invasive~     hemodynamic monitors used in the operating room to known changes in the intravascular volume~     status that occur during blood removal and volume replacement with three different standard~     fluids used during ANH.~   "
106010|NCT02179814|"~     Bulimia nervosa is a severe psychiatric disorder characterized by recurrent binge eating~     episodes followed by inappropriate compensatory behavior to prevent weight gain such as~     self-induced vomiting. With this project, the investigators want to investigate the role of~     the neurotransmitter dopamine in bulimia nervosa. Dopamine is reported to have an important~     influence on the neural reward system and is involved in the processing of gains and losses.~     The reward system is functionally connected to the individual perception of rewards in the~     environment. A previous study revealed that under catecholamine depletion including dopamine~     depletion women suffering from bulimia nervosa in their past reported mild bulimic symptoms~     and their reward processing became dysfunctional: their ability to use rewarding stimuli for~     task solving was diminished.~      The aim of this study is to investigate the role of reduced dopamine availability in the~     development or maintaining of bulimia nervosa and in the dysfunctional processing of~     rewarding stimuli and negative visual information. Therefore, the investigators hypothesize~     that catecholamine depletion achieved by oral administration of alpha-methyl-paratyrosine~     (AMPT) will induce mild bulimic symptoms in females suffering from bulimia nervosa in their~     past. In addition, they will reveal dysfunctions in reward and emotional processing under~     catecholamine depletion. Using functional magnetic resonance imaging, the investigators~     propose that a reduced activation of the nucleus accumbens, a neural structure of the reward~     system, will be the neural correlate of this dysfunctional reward processing. Furthermore,~     the amygdala, a neural structure that is involved in emotional processing, will show a higher~     activation under catecholamine depletion. Genetic factors additionally have an influence on~     the dopaminergic system. Therefore, the investigators hypothesize that genetic factors, for~     example the COMT val-158-met polymorphism may have an effect on the behavioral and neural~     response to catecholamine depletion. In sum, this investigation may help to understand which~     changes in reward and emotional processing may lead to a reoccurrence of bulimic symptoms.~      In future, the findings of this study may help to develop individual pharmacological and~     psychotherapeutical interventions to enhance the outcome of treatment.~   "
106011|NCT02179801|"~     The aim of the cohort study SCAN (Screening Cardiovascular patients for Aortic aNeurysms) is~     to establish a screening programm for patients with a high risk for an AAA. Aortic aneurysms~     in these patients should be identified at an early stage and thereby AAA-associated mortality~     be decreased.~   "
106012|NCT02179788|"~     Most new mothers in the United States will start off breastfeeding. For some mothers, despite~     following best practices, they are not able to meet their breastfeeding goals due to~     unexplained low milk supply. At the same time, nearly 1 in 4 new mothers are pre-diabetic~     (elevated blood sugar, but not yet diabetic). My progression of research suggests that the~     same metabolic factors causing pre-diabetes may also be causing low milk supply. Metformin is~     a widely prescribed drug to treat high blood sugar. This study is a preliminary, small scale~     randomized trial designed to test for a trend in the hypothesis that metformin is safe and~     potentially effective in treating low milk supply in insulin resistant and pre-diabetic~     mothers.~   "
106013|NCT02179775|"~     The purpose of this study is to determine whether Quince Oxymel is effective in the~     prevention of Migraine attacks in patients with simultaneous upper gastrointestinal~     dysfunction.~   "
106014|NCT02179762|"~     This randomized pilot clinical trial compares vigorous or moderate exercise in enhancing~     active surveillance in patients with prostate cancer that has not spread to nearby lymph~     nodes or to other parts of the body. Active surveillance involves watching the patient's~     condition but not giving any treatment unless test results show that the patient's condition~     is getting worse. Exercise may improve fitness, quality of life, brain health, and blood~     biomarkers in patients with prostate cancer on active surveillance. It is not yet known~     whether vigorous or moderate exercise works better in enhancing active surveillance in~     patients with localized prostate cancer.~   "
106015|NCT02179749|"~     This is an 8-week, randomized, double-blind, placebo-controlled, 3 arm, parallel groups,~     dose-ranging study of 1-week of treatment with mifepristone (0, 600, 1200 mg/d) given in~     conjunction with 8 weeks of manual-guided counseling, and a follow-up visit at Week 12.~   "
106016|NCT02179736|"~     This is an open, non-comparative study to evaluate effectiveness and safety of Restylane in~     correction of nasolabial folds up to 12 months after the initial treatment, and to evaluate~     the safety of repeat treatment of the nasolabial folds 12 months after the initial treatment.~   "
106017|NCT02179723|"~     This clinical study aims to assess whether the benefits of using Leukosan Adhesive on trocar~     incisions are greater or equivalent to those provided by the standard therapy of~     transcutaneous sutures.~      In particular, it tests the long-term cosmetic result after 3 months, the safety and~     tolerance, as well as the practicality of treatment with Leuksan Adhesive.~      An open, randomised, controlled, prospective, single location, clinical study of women of~     ages between 18 and 60 years within the time span of March 2013 and April 2013.~   "
106018|NCT02179710|"~     Real-world adherence to inhaled and oral therapies for cystic fibrosis (CF) patients remains~     discouragingly low, ranging between 31-53% for inhaled antibiotics and 41-72% for hypertonic~     saline. Programs to enhance adherence, including comprehensive behavioral interventions with~     adolescents, have met with mixed success. Advances in therapy, treatment delivery systems,~     and data capture technology offer the potential for enhancing adherence by providing~     immediate and more frequent feedback to the patient regarding his or her fidelity to the~     prescribed treatment regimen. We propose to conduct a proof-of-concept study to evaluate a~     systematic approach to linking treatment and feedback components to enhance adherence.~   "
106019|NCT02179697|"~     The purpose of this study is to compare surgery plus bracing versus bracing alone. Both~     groups are considered standard of care treatments. The goal of this study is to determine~     which group is a better treatment.~   "
106020|NCT02179684|"~     The purpose of this study is to investigate if an early surgical intervention on patienst~     with Bell´s Palsy has a better impact on their facial muscular function and their quality of~     life as compared to conventional therapy.~   "
106021|NCT02179671|"~     Primary objective: To assess the efficacy of various sequences of either a small molecule or~     an IMT (IMT-A) followed by a IMT-B (MEDI4736) .~   "
106024|NCT02179632|"~     Pharmaceutical and medical device manufacturers work closely with doctors and hospitals, and~     the companies often pay large sums for consulting and advising services. Recipients of these~     payments and companies have stated that these financial relationships contribute to~     innovation in health care. However, multiple studies have also found that such payments have~     the potential to bias prescribing and treatment behaviors, and thus may lead to increases in~     health care costs.~      One way to address potential conflicts of interest in medicine is public disclosure. As part~     of the Affordable Care Act, the Physician Payment Sunshine Act (PPSA) will establish a~     national disclosure website that posts all payments from pharmaceutical, medical device, and~     biologics manufacturers to doctors and hospitals starting in 2014. Payments exceeding $10~     must be reported, and they will be listed by category, such as speaking engagements, meals,~     travel, and consulting services.~      The Centers for Medicare and Medicaid Services (CMS) explicitly state in their Final~     Regulations for the PPSA that the disclosure website will permit patients to make better~     informed decisions when choosing health care professionals and making treatment decisions,~     but the ways in which patients will evaluate and interpret disclosure remain unclear. One~     prominent topic in the discussion of disclosure is patient trust in health care providers and~     how transparency will affect the patient-doctor relationship—and, consequently, how the new~     law may affect physicians and hospitals.~   "
106025|NCT02179619|"~     The study is to verify that Dermalax (Deep) is not inferior to the reference device,~     Restylane®, in terms of efficacy and safety in the correction of nasolabial folds. Subjects~     who voluntarily signed the informed consent and are judged to be eligible for this study will~     be intradermally injected both of study device and comparator device. Subjects will be~     randomized to receive injection of study device and comparator device on their each~     nasolabial fold. Efficacy is evaluated based on the change in Wrinkle Severity Rating Scale~     (WSRS) from baseline. Safety will be assessed based on 24 weeks follow up visits and subject~     diary which will be given to subjects during the first 2 weeks after the injection. Any~     uncomfortable things and adverse events will be investigated from subject diary and follow up~     visits.~   "
106026|NCT02179606|"~     This study is to verify that Dermalax Implant Plus is not inferior to the reference device,~     Restylane® Sub-Q, in terms of efficacy and safety in the correction of nasolabial folds~   "
106027|NCT02179593|"~     A few studies state that 3-segment SARPE has the following advantages: a) higher level of~     expansion symmetry; b) higher level of stability of the expansion achieved; and c) faster~     bone healing. The investigators hypothesize that 2-segment SARPE is as effective as 3-segment~     SARPE concerning treatment and/or quality of life in daily practice.~   "
106028|NCT02179580|"~     Ministry of Health and Welfare Department of Chinese Medicine and pharmacy specially~     subsidizes domestic teaching hospitals to install clinical study centers for Chinese~     pharmacies, in order to establish the clinical study environment for Chinese pharmacies~     meeting the international regulations, to assist promoting and performing clinical studies in~     Chinese pharmacies, and then to improve the nation's health and benefits. This will render~     Chinese pharmacies competitive in the international market by employing scientific tests and~     verifications. The new project applications are respectively as follows: A randomized double~     blind placebo control study of Xiang-Sha-Liu-Jun-Zi-Tang (XSLJZT) in patients with irritable~     bowel syndrome The main clinical manifestations of irritable bowel syndrome (IBS) are~     chronic, recurrent abdominal pain or abdominal dyscomfortable associated with the changes of~     defecation habit, such as constipation and/or diarrhea. Clinical treatment of IBS includes~     behavioral, and drug treatment, such as anti-diarrheal agent, 5-HT3 receptor antagonist and~     5-HT4 receptor agonist, but these treatments relieve partial symptoms only.~     Xiang-Sha-Liu-Jun-Zi-Tang (XSLJZT) origins from Yizongjinjion, and that uses XSLJZT to treat~     the patients who has qi deficiency, phlegm-retained fluid, nausea and vomiting,~     gastrointestinal dysharmony and producing many symptoms. These symptoms of mentioned-above~     are similar to IBS. Therefore, the purpose of the present study was to investigate the~     therapeutic effect of XSLJZT on IBS, the investigators designed a randomized double blind~     placebo control study to assess the effect of XSLJZT on IBS.~   "
106029|NCT02179567|"~     The investigators propose to study the efficacy and safety of the combination of Docetaxel~     plus Bevacizumab in a Phase II trial of elderly subjects with non-small cell lung cancer~   "
106030|NCT02179554|"~     The loss of the sense of smell, anosmia, can have profound effects on the lives of those who~     suffer from it. In our clinical practice, we have encountered several patients complaining of~     anosmia after recently undergoing surgery requiring cardiopulmonary bypass. We want to~     investigate this peculiar observation and determine if such a link exists. Thus far, there~     have been no similar studies published, and as such, no previous evidence on this matter.~     This study will help formalise and clarify these observations, empowering clinicians to~     better inform patients in the future; if cardiopulmonary bypass procedures do carry a risk of~     anosmia. This study may also give rise to further research into the matter.~   "
106031|NCT02179541|"~     Otitis media with effusion (OME) cases refer to a clinically silent condition. Otoscopic~     findings are subjective and not always reliable. As an objective test tympanometric~     evaluation is imperfect for diagnosis of OME. The objective of our study was to investigate,~     in OME cases, the correlation of tympanic membrane color changes with the presence and~     viscosity of effusion in the middle ear. The study aimed to provide objective diagnostic and~     therapeutic criteria for patients scheduled for surgery by 2 means: measuring the viscosity~     of the fluid and evaluating color changes objectively with red-green-blue (RGB) measurements.~   "
106032|NCT02179528|"~     Patients with extensive-stage small cell lung cancer receive six cycles of~     chemotherapy(etoposide plus platinum) as first-line treatment,who achieve Complete~     Response(CR)/Partial Response(PR) will accept small doses of etoposide as maintenance~     treatment. The objective of this study is to evaluate the progression free survival,overall~     survival,objective response rate,disease control rate and safety of etoposide as maintenance~     therapy. Based on previous studies on maintenance therapy in small cell lung cancer,the~     hypothesis of this study is maintenance therapy using etoposide may improve progression free~     survival,overall survival for selected patients. The investigators will use the peripheral~     blood to assess circulating tumor cell and cell-free DNA,which may help us to screen a~     subgroup of patients with better response to etoposide maintenance therapy.~   "
106033|NCT02179515|"~     Background:~      - This cancer vaccine was developed to help teach the body's immune system to attack and~     destroy cancer cells. It teaches immune cells to target the Brachyury protein. This protein~     is present in some tumor cells, and it can help tumor cells spread to other parts of the~     body. Researchers want to see whether the new Brachyury protein vaccine can help treat people~     with advanced carcinomas.~      Objective:~      - To test the safety and effectiveness of giving the MVA-brachyury-TRICOM vaccine to people~     with cancer.~      Eligibility:~      - Adults ages 18 and over whose type of cancer has not responded to standard therapies who do~     not have a history of autoimmune diseases and are capable of taking care of themselves.~      Design:~        -  Participants will be screened with a medical history and physical exam. They will have~          blood and urine tests. They may have a computed tomography (CT) scan, a positron~          emission tomography (PET) scan, and a brain magnetic resonance imaging (MRI) scan. They~          may have a bone scan. They will have an electrocardiogram (ECG) to test heart rhythm.~        -  Participants will have visits about every 4 weeks. They will have a physical exam and~          blood and urine tests. They will be injected with the vaccine under the skin into the~          upper thigh or around the armpits.~        -  CT scans or MRI scans will be done at visit 1, after 3 months on study, and again 3~          months later if still on the study. Another ECG will be done at their last vaccine~          visit.~        -  When participants stop the vaccine, they will return for visits until they recover from~          any side effects. They will have tests including physical exam, blood tests, scans, and~          x-rays.~        -  Participants will be asked to enroll in another study for long-term follow-up.~   "
106034|NCT02179502|"~     The purpose of this First-in-Human study is to evaluate the safety and tolerability after~     single ascending oral doses of GLPG1690 given to healthy male subjects, compared to placebo.~     Also, the safety and tolerability of multiple ascending oral doses of GLPG1690 given to~     healthy male subjects daily for 14 days compared to placebo, will be evaluated.~      Furthermore, during the course of the study after single and multiple oral dose~     administrations, the amount of GLPG1690 present in the blood and urine (pharmacokinetics) as~     well as the reduction of biomarker levels by GLPG1690 in plasma samples (pharmacodynamics)~     will be characterized compared to placebo.~      The pharmacokinetics of a solid dosage formulation of GLPG1690 will be compared with those of~     a liquid dosage formulation of GLPG1690.~      Also, the potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1690~     will be explored.~   "
106035|NCT02179489|"~     Multicentric randomised trial. The goal of this clinical research study is to learn if~     hyperthermic intraperitoneal chemotherapy (HIPEC) will help to decrease the rate of~     peritoneal carcinomatosis(PC) in patients with high risk of developing PC of colorectal~     cancer. The safety of this treatment will also be studied.~   "
106036|NCT02179476|"~     A non-randomized, multi-site feasibility study to evaluate the safety of the Glyder Device in~     subjects with a history of lumbar facet joint disease (L2 to the sacrum) and successful~     neural ablation in which the facet joint is confirmed as the source of pain.~   "
106037|NCT02179463|"~     RATIONALE: Neoadjuvant chemotherapy has been proved effective for locally advanced gastric~     cancer, yet the best pattern of response evaluation remain unknown.~      PURPOSE: Compare different pattern of response evaluation for Gastric Cancer.~   "
106038|NCT02179450|"~     Based on recent findings that botulinum toxin injections in the cranial muscles might reduce~     emotional processing (Havas 2011), an increasing number of popular newspaper tabloids are~     suggesting a negative effect on cognition. The underlying research articles address the~     facial feedback hypothesis. The hypothesis indicates that expressive behaviour, including~     facial mimic expressions influences the subject's brain via feedback. (Alam 2008) Other~     systemic neurological diseases, e.g of inflammatory origin, may lead to temporary bilateral~     facial nerve palsy (BF). During recovery process, the palsy usually remits completely.~      The effect of bilateral facial muscle palsy on cognition and emotional possessing has never~     been evaluated.~      The results of this pilot study might provide new information about the effect bilateral~     facial palsy on emotional processing and cognition and the facial feedback hypothesis.~      The aim of this controlled pilot study is to assess cognitive function and emotional~     processing in patients with bilateral facial palsy. In addition, differences in cognitive~     function and emotional processing in patients with different manifestations of dystonia~     should be evaluated.~      According to the facial feedback theory, paralysed mimic muscles might alter emotional~     processing. Therefore, investigators compare patients with bilateral facial muscle palsy and~     healthy controls. Investigators expect no influence of facial muscle palsy on cognitive~     functions in any of the tested groups; the investigators expect a mild impairment of~     emotional processing only in the patients group with bilateral facial muscle palsy (BEB and~     BF). In addition, the investigators expect no difference in emotional processing in patients~     with different manifestations of dystonia (BEB and CD) at remission. There might be a slight~     difference of emotional processing in patients with different manifestations of dystonia (BEB~     and CD) at time of prominent facial palsy.~   "
106039|NCT02179437|"~     Postoperative pain can be severe after liver resection surgery. However, postoperative pain~     management may be difficult for this group of patients. Opioidergic neurotransmission may be~     altered in cirrhotic patients and selectively increasing receptor affinity for opioids. Large~     dose of strong opioid may be required to achieve adequate pain control. However, this may not~     be possible due to the side effect of opioid and liver dysfunction after liver resection.~      Propofol is a commonly used anaesthetic with rapid recovery and less side effects and TIVA~     (total intravenous analgesia) with propofol is a common technique now. The reduction on~     certain serum pro- inflammatory cytokines may lead to more smooth post- surgical recovery.~      Recent case report proved the analgesic effect of propofol infusion. However other animal and~     clinical studies showed controversial result.~      The aim of this retrospective study is to investigate the postoperative analgesic effects and~     side effects of intraoperative TIVA with propofol in patient undergoing liver resection~     surgery at Queen Mary Hospital, Hong Kong between 2010 to 2012.~   "
106040|NCT02179424|"~     Previous research shows a significant proportion of smokers work in full-time employment.~     Given that the majority of smokers do not aware of the smoking cessation services available~     in Hong Kong, implementing smoking cessation policy in the workplaces may assist a~     considerable number of smokers to stop or reduce smoking.~      This study aims to:~        1. examine the employers' knowledge, attitudes and practices in promoting smoking cessation~          in workplace.~        2. test the effectiveness of a brief and an intensive smoking cessation interventions to~          help workers stop smoking~      In Phase I of this study, a large scale cross-sectional survey will be conducted to 3000~     corporate companies in Hong Kong. The questionnaire will examine the employers' knowledge,~     attitudes and practices in promoting smoking cessation in the workplaces.~      In Phase II, a longitudinal study will be conducted to evaluate the effectiveness of a~     smoking cessation intervention offered by the Department of Psychology, the University of~     Hong Kong. Smokers from the participating companies will be interviewed before the~     intervention at baseline, immediately after the intervention, and at 1-, 4-, 12-, 26- and~     52-week post-intervention follow-ups.~      The follow-up assessments will consist of a biochemical validation for the self-reported~     quitters who report quitting in the past 7 days via exhaled carbon monoxide and saliva~     cotinine concentration tests. Participants' smoking behaviour, knowledge on smoking and~     satisfaction of the smoking cessation services will also be evaluated.~      It is hypothesized that the smoking cessation intervention helps workers stop smoking.~     Employers' knowledge and attitudes are positively associated with the practices in promoting~     smoking cessation in workplace.~      Process evaluation: Qualitative interviews, including in-depth interviews and/or focus group~     will be conducted after 6-month follow-up.~   "
106574|NCT02172430|"~     The objective of this study is to investigate the long-term safety of Ba 79 BR (tiotropium)~     powder inhalation in patients with COPD using oxitropium bromide (Tersigan) as a comparator.~     Secondarily, the long-term efficacy of Ba 679 BR is also investigated~   "
106042|NCT02179398|"~     Detecting serious bacterial infections (SBI) in children presenting to the Pediatric~     Emergency Department (PED) with fever without source (FWS) is a frequent diagnostic~     challenge. The recently described Lab-score, based on the combined determination of~     Procalcitonin, C-Reactive Protein (CRP) and urine dipstick results, has been shown an~     accurate tool for SBI prediction on retrospective cohorts. The investigators aimed to assess~     the usefulness of the Lab-score in safely decreasing unnecessary antibiotic prescriptions in~     children with FWS, and to prospectively determine the diagnostic characteristics of the~     Lab-score compared to other classically used SBI biomarkers (white blood cell (WBC) count,~     band count and CRP).~   "
106043|NCT02179385|"~     CHANGE-D objectives are to evaluate to what extent personal coaching for healthy lifestyle~     and treatment adherence improves clinical outcomes among uncontrolled diabetic patients.~      Evaluate to what extent personal coaching for healthy lifestyle and treatment adherence~     improves self treatment among uncontrolled diabetic patients.~   "
106044|NCT02179372|"~     The aim of this study is to test Eicosapentaenoic free fatty acid's effects on calprotectin~     levels in IBD patients in clinical remission. During the study fecal calprotectin levels will~     be measured every 3 months and clinical flares will be registered.~   "
106045|NCT02179359|"~     This is a study to collect the outcomes of stem cell transplantation for patients with~     hematologic diseases other than cancer.~   "
106046|NCT02179346|"~     Non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in patients with~     full thickness cartilage defects in the hip.~   "
106047|NCT02179333|"~     The objectives of this study are:~        -  To validate the inter-rater and intra-rater reliability of a new scale for the~          assessment of ataxia and neurologic dysfunction (STAND)~        -  To assess common constructs and correlation between STAND subscale items.~   "
106048|NCT02179320|"~     AIM OF INVESTIGATION: To evaluate in a prospective, randomized, sham-controlled study the~     pattern of analgesic efficacy of trigger point dry needling in Myofascial Pain Syndrome (MPS)~     patients.~   "
106049|NCT02179307|"~     The literature is not clear as to which training volume to employ during initial phases of~     resistance training programs to ensure optimal muscular adaptations. The purpose of this~     study is therefore to compare effects of strength training with low versus moderate volume on~     muscular function and hypertrophy in previously untrained, healthy individuals. Furthermore,~     the investigators will relate individual variation in responses to proxy markers of~     individual training state, such as baseline muscular function and muscle fiber type.~      The study will include 25 women and 25 men and will consist of a 12-week resistance training~     protocol. Each study participant will act as their own control, performing both the low-~     (1-set) and the moderate-volume (3-sets) protocol, allocated to either the dominant or~     non-dominant leg, in a stratified and randomized fashion.~      Primary outcome measures are thigh muscle cross section area and unilateral knee extension~     strength. Additionally, muscle fiber type composition will be evaluated as well as additional~     parameters of muscular function.~      The primary hypothesis is that low-volume protocols will be beneficial for individuals with~     glycolytic muscle phenotypes, whereas the opposite will be true for individuals with more~     aerobic phenotypes.~   "
106050|NCT02179294|"~     Childbirth can be an extremely painful and the provision of pain relief during labour is a~     vital component of a positive maternal experience. The majority of women who deliver in~     modern obstetric units choose a pharmacological method of pain relief, including Entonox, the~     injection of opioids or epidural placement. The commonest opioid used in labour is pethidine~     administered by intramuscular (im) injection. The effectiveness of pain relief provided by~     pethidine has long been challenged. Its shortcomings are more serious when set against known~     side effects including maternal sedation, nausea and potential transfer across the placenta~     to the foetus. More than a third of women who receive pethidine subsequently require an~     epidural due to inadequate pain relief. Epidurals provide highly effective pain relief, but~     increase the risk of a forceps or suction delivery resulting in prolonged hospital stay.~     Therefore, there is a clear need for a safe, effective, easy to administer analgesic~     alternative.~   "
106051|NCT02179281|"~     The aim of the study is to prove whether the use of the SmartGuard feature of the MiniMed~     system significantly reduces hypoglycemic excursions and thus provide proactive protection to~     the user.~   "
106052|NCT02179268|"~     The aim of this five arm randomized trial was thus to compare selective serotonin reuptake~     inhibitor (SSRI)sertraline and citalopram to a dual reuptake inhibitor venlafaxine, a~     nor-adrenaline reuptake inhibitor reboxetine and a control group receiving placebo, with the~     primary endpoint being bone mineral density, and secondary endpoints being bone turnover~     markers.~   "
106053|NCT02179255|"~     Synthetic human growth hormone (HGH) has been available for more than a decade for specific~     indication in children and adults. Past Randomized Control Trials (RCT)s of HGH (under~     off-label use) for improving ovarian function have shown that a combination of traditional~     gonadotropin ovulation induction protocols, with addition of HGH is effective in increasing~     pregnancy rates, but not increasing egg production after IVF in women with documented~     diminished ovarian reserve (DOR). The investigators hypothesize that by initiating HGH at~     least 6 weeks prior to IVF start, the investigators will be able to increase production of~     oocytes and further improve pregnancy chances. This hypothesis is based on prior observations~     of effects of growth hormone on small antral follicles and the fact that prior studies~     utilized HGH principally only during ovulation induction itself.~      The investigators plan to recruit 30 women (15 in each group) to an open label randomized~     controlled trial of HGH for augmentation of ovarian response among women with documented DOR~     and poor prior response to ovulation induction.~      Eligible participants will be women < 45 years with documented history of prior retrieval of~     2 or fewer oocytes while on maximal ovulation induction despite prior supplementation with~     dehydroepiandrosterone (DHEA).~      Women will be treated with 1.9 mg (5.7 units) of HGH per day, beginning about 6 weeks before~     start of their treatment cycle. Cost of treatment with HGH will be a cost to the~     participating patient. HGH will cost the patient approximately $800 per week of treatment.~     Patients who are randomized to the non-HGH treated group, and do not conceive, will in the~     following cycle be offered HGH supplementation outside of this clinical trial. This~     subsequent cycle will not be part of the study dataset and patients will also be responsible~     for the cost of HGH.~      Even with only 7 patients in each group, this trial will have a 99% power (error 0.05%) to~     detect a mean increase to 4 oocytes in the treated group. The investigators plan to recruit~     15 patients in each group to allow for possible dropouts.~   "
106054|NCT02179242|"~     The aim of the investigators' project is to determine if patients admitted with a primary~     diagnosis of heart failure to Sanford Health facilities in regional southeastern South Dakota~     demonstrate benefits in improvement in functional capacity, quality of life, and a reduction~     in hospital readmission rates from a cardiac rehab program immediately following a discharge~     for an acute decompensated heart failure diagnosis related inpatient hospitalization~     encounter. The investigators hypothesize that those that receive cardiac rehab will have~     improved quality of life and reduced readmission rates at 30 and 90 days.~   "
106055|NCT02179229|"~     The purpose of this study is to establish whether a short treatment with the synbiotic~     combination Probinul neutro® may decrease the plasma concentration of the uremic toxin~     p-cresol in patients bearing a kidney allograft. The effect of this treatment on plasma~     levels of immunosuppressant drugs will be evaluated as well.~   "
106056|NCT02179216|"~     Primary objective: To compare the decrease in systolic blood pressure between hydration and~     venous contention when switching to a standing position. Hypothesis in that hydration is~     better than venous contention.~      Secondary objective: To evaluate the effect of hydration on lowering systolic blood pressure~     during the passage standing in elderly patients with orthostatic hypotension.~      Inclusion criteria: Patient aged over 75 years old with orthostatic hypotension proved to 1~     and / or 3 min~   "
106057|NCT02179203|"~     Study Purpose and Rationale The purpose of this study is to evaluate the lung Doppler signals~     changes during cardiac resynchronization procedure. As the LDS represent the various~     mechanical events of cardiac origin it is assumed that they may reflect the relative timing~     between contraction of the ventricles and atria and thus serve for effective synchronization~     of these activities.~      Aim of the study:~      The aim of the study is to assess whether the changes in Lung Doppler Signal (LDS) waves'~     characteristics will mimic the changes in echocardiographic parameters designed to assess~     diastolic inflow and systolic flow in patients undergoing Echo-based CRT optimization.~   "
106058|NCT02179190|"~     Single arm study to evaluate the outcomes of treatment with the Barrel VRD device as an~     adjunctive treatment to coiling for wide neck, intracranial, bifurcating/branching aneurysms~     in the middle cerebral and basilar arteries.~   "
106059|NCT02179177|"~     In patients with SCD, the use of low dose anticoagulation as an outpatient may lead to a~     significant decrease in morbidity and as a result, decrease healthcare utilization and costs.~     This study attempts to critically avoid admissions by reducing daily pain scores and pain~     crisis as an outpatient by use of a novel oral anticoagulant.~   "
106060|NCT02179151|"~     The purpose of this study is to evaluate efficacy and safety of ZGN-440 (beloranib) in obese~     adolescent and adult subjects with Prader-Willi Syndrome.~   "
106061|NCT02179138|"~     To assess the acceptability of a user-filled, paper, applicator for delivery of tenofovir~     (TFV) gel among women at high risk of acquiring human immunodeficiency virus (HIV) in rural~     KwaZulu-Natal, South Africa.~   "
106062|NCT02179125|"~     Rationale: The PneumRx RePneu Lung Volume Reduction Coil (RePneu LVR-coil) is a bronchoscopic~     lung volume reduction treatment designed to compress the areas of lung parenchyma most~     damaged by emphysema. The LVRC treatment was found to be feasible, safe and effective in~     previous studies. However, patient-based outcomes besides quality of life questionnaires are~     hardly measured after intervention treatments for COPD. Furthermore, the exact underlying~     physiological mechanism of the LVR-coil treatment is unknown. Another aspect of the treatment~     which we to date do not fully understand is which group of patients benefit of the treatment~     and which group of patients do not, this knowing that the responder rate is already about~     60%.~      Objective: The objectives of the study are to gain more knowledge on 1) the effect of the~     LVRC treatment on patient-based outcomes like physical activity, 2) the underlying~     physiological mechanism of the treatment, 3) the predictors of response to the treatment at~     baseline, and 4) on a targetted treatment number of coils to be placed per lung using lung~     compliance.~      Study design: This study is a non-randomised open label multi-center intervention study.~      Study population: The study population exists of adult patients with severe emphysema with no~     other treatment options left besides surgical procedures.~      Intervention: Bilateral bronchoscopic lung volume reduction treatment with RePneu coils.~      Main study parameters/endpoints: The main study endpoint is the change in physical activity~     between baseline and 3 months follow-up after the second treatment. The secondary endpoints~     are the changes between baseline and 3 months follow-up after the second treatment in:~     patient reported outcomes of the treatment, dynamic lung hyperinflation, static lung volumes,~     lung compliance, diaphragm function, lung perfusion, systemic inflammation and small airways~     function.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: The LVR Coil has been designed to be as safe as possible. It was shown that the~     risks associated with the LVRC system are largely attributable to the bronchoscopic procedure~     itself rather than to the device per se. Therefore, it appears that the LVRC device itself~     does not appreciably increase the risk of serious adverse events beyond the risk of~     undergoing a bronchoscopy procedure or simply having emphysema. Currently, this treatment is~     not commercially available in the Netherlands and study participants will have to visit the~     hospital multiple times. Previous studies have shown that the treatment has beneficial effect~     for the patient, however not all patients respond. Part of this new study is to try to~     identify which group of patients respond to the treatment and which patients do not.~     Therefore, it is possible that a patient will not receive any benefits from the treatment.~   "
106063|NCT02179112|"~     A multicentre, international evaluation of emergency abdominal surgery to establish surgical~     outcomes and identify common, modifiable best practice processes.~   "
106064|NCT02179099|"~     This is a single arm pilot study evaluating the feasibility and preliminary safety of a~     single intravesical instillation of TC-3 gel mixed with botulinum toxin (BTX) for symptomatic~     improvement in overactive bladder patients.~   "
106065|NCT02179086|"~     This randomized phase II trial studies how well dose-escalated photon intensity-modulated~     radiation therapy (IMRT) or proton beam radiation therapy works compared with standard-dose~     radiation therapy when given with temozolomide in patients with newly diagnosed glioblastoma.~     Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells~     and shrink tumors. Specialized radiation therapy that delivers a high dose of radiation~     directly to the tumor may kill more tumor cells and cause less damage to normal tissue.~     Drugs, such as temozolomide, may make tumor cells more sensitive to radiation therapy. It is~     not yet known whether dose-escalated photon IMRT or proton beam radiation therapy is more~     effective than standard-dose radiation therapy with temozolomide in treating glioblastoma.~   "
106066|NCT02179073|"~     Bladder management has a major impact on the quality of life in patients with neurogenic~     bladder dysfunction. This a prospective investigation of the effects of the method for~     bladder evacuation on the health-related quality of life in patients with neurogenic bladder~     dysfunction. The changes in health-related quality of life over time (longitudinal~     investigation) and the differences between the different methods for bladder evacuation will~     be investigated. Patients will be given a standardized and validated questionnaire annually~     for 10 years.~   "
106095|NCT02178696|"~     Major depression is a highly prevalent, frequently debilitating illness that too often fails~     to respond to currently available treatments such as antidepressant medication. Furthermore,~     randomized controlled trials of antidepressants consistently demonstrate large placebo~     effects. The investigators hypothesize that individual differences in the function of key~     brain circuits underlie the observed variability in clinical responses to both placebo and~     antidepressant medication. This study will test this hypothesis by recruiting~     treatment-seeking volunteers with major depression, with or without comorbid nicotine~     dependence. Volunteers will participate in positron emission tomography (PET) and functional~     magnetic resonance imaging (fMRI) scans in the context of a treatment trial in which they~     will receive both placebo and antidepressant medication. A major goal of the study is to~     improve prediction of individual clinical responses in future treatment trials in which brain~     imaging may be unavailable, and to study the mechanisms of antidepressant response in Major~     Depression.~   "
106067|NCT02179060|"~     Therapeutic hypothermia improves the neurologically-intact survival rates in those patients~     resuscitated out-of-hospital from ventricular fibrillation. Cooling as early as possible~     might be beneficial to those victims. Diffusion Tensor Imaging and diffusion-weighted~     magnetic resonance imaging have recently shown to be able to identify early ischemia-related~     changes within the brain three days after cardiac arrest, among sudden cardiac arrest~     patients cooled in hospital. The physical changes seen within the brain may be able to~     distinguish survivors at very early phase.~      This study aims to assess early ischemia-related changes of the brain seen in MRI~     approximately three days after cardiac arrest. The hypotheses is that MRI will differ in the~     groups of patients treated with early intra-arrest cooling with the RhinoChill device and in~     hospital hypothermia in 36 Celsius, in the group of patients treated with normal in hospital~     hypothermia in 36 Celsius only, in the group of patients treated with normal in hospital~     hypothermia in 33 Celsius only (The historical Xenon study patients). The primary endpoint is~     the presence and pattern of white matter and gray matter degeneration and volumetric changes~     of the gray matter, white matter, and cerebro-spinal fluid spaces in MRI, and secondary~     endpoints are total survival at 90 days, and time to reach a target temperature (≤36/33~     Celsius).~   "
106068|NCT02179047|"~     Through the literature review , we pick out a series of forward-looking biological indicators~     as follows :~        1. NGAL~        2. Cystatin C:~        3. Galectin-3:~        4. Copeptin:~        5. MR-Pro ANP:~        6. sST2:~   "
106069|NCT02179034|"~     This study is to examine if inhaled doses of menthol that produce low and high cooling~     effects change the appeal of e-cigarettes containing low and high doses of nicotine in~     adolescent smokers. The hypothesis is that the combination of nicotine and menthol, when~     compared with menthol or nicotine alone, will result in greater increase in liking of an~     e-cigarette and greater reduction in nicotine withdrawal.~   "
106070|NCT02179021|"~     The purpose of this study is to investigate, if the haemostasis is impaired in cardiac arrest~     patients during therapeutic hypothermia compared with normothermia.~   "
106071|NCT02179008|"~     The purpose of this study is to investigate the safety and efficacy of five concentrations of~     DE-117 ophthalmic solution.~   "
106072|NCT02178995|"~     Methylphenidate (MPH) has long been used to improve attention and cognitive difficulties~     associated with ADHD, including in children with ADHD and epilepsy (Torres et al., 2008).~     Methylphenidate (MPH) is also helpful in treating attention and other cognitive difficulties~     in a variety of other neurological and medical conditions (Kajs-Wyllie, 2002; Prommer, 2012).~     We seek to evaluate the potential efficacy and safety of this medication in treating~     attention deficits, as well as other cognitive difficulties, experienced by adult patients~     with epilepsy.~      To our knowledge, there are currently very few studies which explicitly examine the impact of~     MPH on measureable attention deficits and other cognitive deficits in adult patients with~     epilepsy. We hope to quantify what impact, if any, methylphenidate has on attention, in~     addition to other specific measureable cognitive functions, in patients with cognitive~     complaints and epilepsy, and contribute to a growing body of evidence which supports the~     safety of methylphenidate's use for attention deficits in patients with epilepsy. As other~     effective treatments for attention and other cognitive difficulties in patients with epilepsy~     are not currently available, MPH could represent an important option in the treatment of such~     patients.~   "
106073|NCT02178982|"~     The Acute Respiratory Distress Syndrome (ARDS) is one of common clinical critically diseases.~     In the United States, the incidence of ARDS reaches 31%, which is one of the main causes of~     death in patients. There is no unified treatment process for ARDS currently and the treatment~     measures are not yet standardized, so the standardization of ARDS treatment processes is~     needed to reduce mortality in patients. Following the evidence-based medicine principles and~     six-step treatment standards of ARDS, this study uses the method of multi-center randomized~     controlled clinical trials to evaluate the standardized treatment process of ARDS, which~     provides the basis for the standardized treatment of ARDS.~   "
106074|NCT02178969|"~     The purpose of this study is to better understand disease extent and to identify appropriate~     methodologies to evaluate (dystrophic epidermolysis bullosa) DEB in a quantitative and~     qualitative manner.~   "
106075|NCT02178956|"~     The purpose of this study is to find out whether it is better to receive a new drug, BBI608,~     in addition to paclitaxel chemotherapy or better to receive paclitaxel chemotherapy alone as~     second line treatment for gastric and gastroesophageal junction cancer after prior first line~     platinum and fluoropyrimidine based chemotherapy.~   "
106076|NCT02178943|"~     Plasma donor-derived cell-free DNA (dd-cfDNA) is measured as a % of the total plasma cfDNA in~     association with the measurement of AlloMap, a non-invasive gene expression test to aid in~     heart transplant management.~   "
106077|NCT02178930|"~     The purpose of this study is to improve the health status of people living with HIV in~     Australia. The overall goal is to rigorously evaluate the impact of interactive health plans~     and self-management support on chronic condition outcomes in people with HIV.~      The specific aims are to:~      Aim 1: Using a doctor-level cluster randomised trial, evaluate the effect of interactive~     health plans and self-management support on coronary heart disease risk and other chronic~     condition outcomes in people living with HIV.~      Aim 2: Evaluate patient and health care provider experiences and acceptability of interactive~     health plans and self-management support.~      Aim 3: Evaluate intervention cost-effectiveness and effect on health service utilisation.~   "
106096|NCT02178683|"~     This protocol will evaluate Tacrolimus and MMF after conditioning with fludarabine and~     low-dose TBI in patients who are not candidates for conventional allografting. A novel~     approach to immunosuppression will be tested incorporating an early but extended taper of~     Tacrolimus starting on day +80 or in the case of relapse. The goal is to induce early~     immunity and GVT effects without compromising GVHD control. The anti-metabolite MMF will be~     re-introduced on day +100 to try and induce tolerance and block chronic GVHD during the taper~     of the Tacrolimus. DLI may be given in the presence of disease progression but not for mixed~     chimerism as in previous protocols.~   "
106136|NCT02178163|"~     This research trial studies comprehensive genomic analysis in tissue samples from patients~     with non-small cell lung cancer that has come back or is stage IV. Comprehensive genomic~     analysis may identify specific gene mutations (changes in deoxyribonucleic acid [DNA]) and~     help doctors to tailor treatment to target the specific mutations.~   "
106078|NCT02178917|"~     Spinal Cord Injury (SCI) affects a person's ability to move and feel sensation in the body.~     SCI is also an indirect cause of a persistent pain, called Central Neuropathic Pain (CNP).~     This pain typically develops several months after the injury. In 30-40% of SCI patients,~     severe CNP affects their everyday living including sleep and mood. Many patients give up~     work, not because of the injury, but because of pain. Medical treatment of CNP is moderately~     effective and costly, both to the patient and to the health care system.~      In previous research, characteristic 'signatures' of brain waves that are probably related to~     CNP have been defined. Based on this, a novel treatment for CNP based on neurofeedback was~     developed and clinically tested on five SCI patients. Electroencephalograph (EEG) was used to~     record patients' brain waves and these were shown to patients on a computer screen in a~     simple graphical form (e.g. bars). Patients were trained to change their brain activity at~     will and, as a consequence, their pain was reduced. Patients who had suffered from CNP for~     years received up to 40 neurofeedback treatment sessions, reducing their pain for several~     days after each session.~      The primary aim of this study is to apply neurofeedback therapy to a larger number of~     recently injured patients, who are still in a hospital. It is hypothesised that neurofeedback~     treatment will be more effective in people who have suffered from CNP for a shorter period of~     time.~      The secondary aim of the study is to define EEG predictors of CNP. EEG will be recorded in~     recently injured patients with no chronic pain, knowing that a certain number of patients~     will develop CNP within weeks or months. These patients will be followed up for a year and~     the EEGs of patients who develop CNP will be compared with those who do not.~   "
106079|NCT02178904|"~     The purpose of this study is determine the diagnostic performance of dual energy computed~     tomography perfusion for non-invasive assessment of the hemodynamic significance of coronary~     stenosis, as compared to a direct measurement of fraction flow reserve during cardiac~     catheterization as a reference standard.~      The overall objective of the present study is to determine the diagnostic performance of dual~     energy computed tomography perfusion for non-invasive assessment of the hemodynamic~     significance of coronary stenosis, as compared to direct measurement of fraction flow reserve~     during cardiac catheterization as a reference standard.~   "
106080|NCT02178891|"~     An extra short, 2-piece implant with a Brånemark hexagon interface was developed with a bone~     anchoring length of only 4.5 mm, for subjects with severely resorbed jaws.~   "
106081|NCT02178878|"~     The purpose of this study is to try to understand why the experience of labor differs among~     women. The investigators want to understand why some women have longer or shorter labors and~     why the amount of pain women experience is different. The investigators hope to be able to~     consider women more individually in terms of their pain and progress of labor.~   "
106082|NCT02178865|"~     The purpose of this study is to assess the accuracy of predicting the normal or carrier~     status of human embryos resulting from in vitro-fertilization (IVF) from patients carrying a~     balanced translocation.~   "
106083|NCT02178852|"~     Electrical stimulation provides direct modulatory effects on subcortical regions. Indeed,~     neuroimaging studies show changes in neural activity in specific brain regions such as the~     amygdala, insula, precentral gyrus, hippocampus and thalamus. The neuroanatomical connections~     established with the trigeminal nerve have been associated with the mechanism called~     bottom-up neuromodulation. According to this hypothesis, the spread of electrical~     stimulation follows a path from the peripheral nerves towards the brain stem was then~     advertise for cortical and subcortical regions. Connections to structures involved in the~     reward system as the amygdala and hippocampus could theoretically modulate dysfunctional~     brain activity in these regions, which may induce favorable clinical effects.~   "
106084|NCT02178839|"~     The Objective of This Study is Evaluating the Effect of oral β- glucan Supplement on~     Anthropometric Measurements, Appetite, Insulin Resistance, Liver echogenicity and Enzymes in~     Non Alcoholic Fatty Liver Patients Treating with Hypocaloric Diet and Vitamin E.~   "
106085|NCT02178826|"~     Nocturnal enuresis (NE) is the involuntary loss of urine that occurs only at night in~     children aged 5 years or more.~      NE is a common problem, affecting about 10% of school children. The prevalence declines with~     each year of maturity but for some it persists in to adolescents and early adulthood. It can~     lead to bad self-confidence and low self-esteem, which can have psychosocial consequences.~      NE is a multifactorial condition. Three central factors have been identified:~      A) Many bedwetting children produce large amounts of urine at night due to a deficiency of~     the antidiuretic hormone vasopressin.~      B) Other children have a lack of inhibition of bladder emptying during sleep. C) Almost all~     children are deep sleepers with high arousal thresholds. They simply don't wake up when the~     bladder is full or when it contracts.~      There are two well established and evidence based treatments today: the bed-wetting alarm and~     the pharmacologic treatment desmopressin. The alarm emits a sound when the child wets the~     bed, which conditions the child to wake up or inhibit bladder emptying. This method is~     curative for about half of the patients who try this, but relapse occurs. Desmopressin is a~     synthetic analog of arginine vasopressin and works by decreasing the urine volume at night.~     About half of the patients become dry with this medication but only as long as they take the~     medicine. To day, at least 25% of all children with NE do not respond to any of the above~     treatment.~      Rapid maxillary expansion (RME) is a common orthodontic technique to treat patients with a~     narrow upper jaw. The brace is fitted by an orthodontist, and has a jack-screw, which is~     activated twice every day for 10-14 days. The procedure is neither painful nor harmful and is~     not very visible at all.~      There are a few reports about children who have become dry after RME treatment. None of them~     have been randomised or placebo controlled but indicates that quite a few children do become~     dry after this treatment. A recently carried out study in Sweden show that half of the~     children became dry after RME treatment. These children were all classed as therapy resistant~     and had already tried the alarm and medication without success.~      The reports are intriguing, but invite the question why a brace would help cure NE? It is~     likely that sleep and respiration is involved. This study will investigate these children's~     sleep during the treatment. The trial is a randomised, placebo controlled trial.~   "
106097|NCT02178670|"~     Most studies of cancer stem cells (CSC) involve the inoculation of cells from human tumors~     into immunosuppressed mice, preventing an assessment on the immunologic interactions and~     effects of CSCs. In this study, the investigators examined the vaccination effects produced~     by CSC-enriched populations from histologically distinct murine tumors after their~     inoculation into different syngeneic immunocompetent hosts. Enriched CSCs were immunogenic~     and more effective as an antigen source than unselected tumor cells in inducing protective~     antitumor immunity.Immune sera from CSC-vaccinated hosts contained high levels of IgG which~     bound to CSCs, resulting in CSC lysis in the presence of complement.CTLs generated from~     peripheral blood mononuclear cells or splenocytes harvested from CSC-vaccinated hosts were~     capable of killing CSCs in vitro. Mechanistic investigations established that CSC-primed~     antibodies and T cells were capable of selective targeting CSCs and conferring antitumor~     immunity.~   "
106098|NCT02178657|"~     This trial aims to test that intra-arterial injection of autologous bone marrow mononuclear~     cells in acute ischemic stroke patients is safe and improves neurological outcomes.~   "
106086|NCT02178813|"~     The purpose of this study is to evaluate the safety and tolerability of high-dose minocycline~     in the patient population undergoing carotid revascularization procedures, namely carotid~     endarterectomy (CEA) and carotid artery stenting (CAS). Establishment of safety will~     facilitate proceeding to a phase II trial.~      During this trial, patients undergoing carotid revascularization procedures will receive high~     doses of minocycline with the following schedule (based on previous trials):~        -  Day prior to procedure: 800mg orally (p.o), 700mg p.o.~        -  Day of procedure: 600mg intravenously( i.v.), 500mg p.o.~        -  Day after procedure: 400mg p.o., 400mg p.o.~      The levels of the drug in the plasma, standard blood tests (complete blood count, creatinine,~     liver function tests) as well as markers of neuronal injury (Neuron specific enolase,~     protein- S100b) and inflammation (C-reactive protein) will also be monitored. The patients~     will be monitored closely for the development of side effects from minocycline.~      MRI imaging will be used to follow the development of small strokes as a result of the~     revascularization procedures and their resolution. The patients of this study, all receiving~     peri-operative minocycline, will be compared with historical controls with regards to~     development of small strokes and persistent of these strokes on subsequent MRI imaging.~   "
106087|NCT02178800|"~     This study will evaluate the safety, tolerability, and pharmacokinetics (which is how the~     body interacts with drugs) of an investigational, injectable HIV medicine (GSK1265744) in~     healthy, HIV-uninfected adults. Researchers will evaluate the use of this medicine for both~     the prevention and treatment of HIV infection.~   "
106088|NCT02178787|"~     Cerebral autoregulation (CA) is a complex mechanism that serves the essential and vital~     purpose of controlling cerebral blood flow and metabolism. A stable and optimal brain blood~     flow is imperative for normal brain function. Diabetes Mellitus (DM ) is associated with~     microvascular disease that alters CA and also with autonomic failure that may lead to~     orthostatic hypotension (OH). These conditions may lead to decreased brain blood flow in~     upright position. This observational study will compare two technologies that evaluate brain~     blood flow during standing up and other maneuvers in people with and without type 2 diabetes.~     These technologies are transcranial Doppler and UTLight technology (CerOx). This study will~     determine the safety and feasibility of CerOx technology for continuous monitoring of~     cerebral blood flow.~   "
106089|NCT02178774|"~     Hypotension after spinal anesthesia for cesarean section is one of the most common~     perioperative issue, with an incidence up to 83%.Hypotension is mainly induced by the~     associated sympathetic blockade, with a drop of peripheral vascular resistance in the lower~     extremities and an increase in venous capacitance. Hypotension is a distress for both~     anesthesiologists and obstetricians as it endangers parturient's hemodynamics and compromises~     the uteroplacental blood flow. In clinical practice, there are several ways to treat~     hypotension after spinal anesthesia such as preloading with intravenous fluids and~     administrating ephedrine. Normotensive maternal blood pressure does neither guarantee the~     well-being of the fetus nor ensure the tissue perfusion of the parturient. Based on the~     anatomy and physiology basis, we hypothesize that uterine perfusion under spinal anesthesia~     would correlate with the perfusion of the lower extremities. To measure the perfusion of the~     lower extremities, we use a relative new tool, the non-invasive transcutaneous near infrared~     spectroscopy.~   "
106090|NCT02178761|"~     Erectile dysfunction is highly prevalent as men grow older. Among the various causes of~     erectile dysfunction, it has been shown that pelvic arterial insufficiency plays a very~     important role. The investigators have recently developed the first imaging analytical~     algorithm by using the abdominal/pelvis multidetector computed tomographic (MDCT) angiography~     to delineate the whole arterial system supplying the penis. To establish a comprehensive,~     cutting-edge diagnostic and interventional therapeutic program for erectile dysfunction, the~     investigators therefore design this series of studies by including experts from Urology,~     Radiology, and Cardiology. This research project (PERFECT program) includes the following 4~     sub-studies: 1) differential frequency of obstructive pelvic arterial lesions in coronary~     artery disease patients with and without erectile dysfunction/lower urinary tract symptoms~     (LUTS), 2) differential frequency of obstructive pelvic arterial lesions in patients with~     vascular risk factors and with or without erectile dysfunction/LUTS, 3) safety, feasibility,~     and efficacy of comprehensive pelvic angioplasty (with various interventional~     strategies/instruments) for patients with erectile dysfunction/LUTS and pelvic obstructive~     arterial disease: proof-of-concept study; and 4) efficacy and safety of comprehensive pelvic~     angioplasty (with various interventional strategies/instruments) for patients with erectile~     dysfunction/LUTS and pelvic obstructive arterial disease: a randomized controlled trial.~   "
106091|NCT02178748|"~     Mycobacterium tuberculosis (M. tb) is a pathogen with worldwide distribution which infects~     humans causing tuberculosis (TB), a transmissible disease resulting in very high mortality~     and morbidity; development of an effective vaccine is a global health priority.~      Over a billion people worldwide are infected with one or more helminths. Helminths are~     parasitic worms, of which Schistosoma mansoni is one species. There is some evidence that~     helminth infection may affect a person's response to a vaccine. In this trial the~     investigators hope to investigate whether Schistosoma mansoni infection affects adolescents'~     responses to a candidate TB vaccine called MVA85A, as adolescents are a crucial target group~     for an effective TB vaccine.~   "
106092|NCT02178735|"~     To evaluate the clinical outcome and urodynamic effect of two novel vaginal tailored mesh~     surgeries.~   "
106093|NCT02178722|"~     The purpose of this study is to assess the safety, tolerability, and efficacy when combining~     MK-3475 and INCB024360 in subjects with certain cancers. This study will be conducted in 2~     phases, Phase 1 and Phase 2.~   "
106094|NCT02178709|"~     The primary objective of this study is to evaluate the rate of pathologic complete response~     to neoadjuvant FOLFIRINOX in patients with resectable pancreatic cancer using a tissue~     collection component.~   "
106099|NCT02178644|"~     This pilot study focuses on KD018 and will investigate the effect of this agent on reducing~     the Gastrointestinal (GI) toxicity associated with combined modality therapy of~     locally-advanced rectal cancer.~   "
106305|NCT02175927|"~     No trial has examined the the efficacy of high dose amoxicillin based quadruple therapy as~     second-line treatment for Helicobacter pylori infection. The study aims to compare the~     effectiveness and safety of 14-day high dose amoxicillin-based quadruple regiment with~     classical quadruple regiment for rescue eradication of Helicobacter pylori.~   "
106306|NCT02175914|"~     Colorectal cancer (CRC) is a leading cause for cancer related mortality in the western world~     with a lifetime risk of 6%. Etiology is complex, while genetic background significantly~     affects the risk. Around one third of all genetic disorders as well as most cases of Familial~     Adenomatous Polyposis (FAP) and a large proportion of all sporadic CRC cases occur as a~     result of premature nonsense mutations (creating a stop codon) in an individual's adenomatous~     polyposis coli (APC) gene. Nonsense mutations are single-point alterations in the DNA that~     prematurely halt the protein translation process, producing a shortened, nonfunctional~     protein. In many of these cases, if the cell can be 'persuaded' to ignore the premature stop~     codon signal, the resulting protein may be able to ameliorate or stop the disease.~      Recently, members of the aminoglycoside family of antibiotics have been found to induce~     ribosomal read-through of nonsense mutations, leading to expression of a full length,~     functional protein. Investigators have recently shown that members of the aminoglycoside and~     macrolide antibiotic families can induce read-through of the nonsense mutations in the APC~     gene and lead to reduced oncogenic phenotypes in CRC cells and in different mice models.~      The aim of this project is to determine the ability of the macrolide antibiotic-erythromycin~     to induce read-through of the nonsense mutations in the APC gene and to induce expression of~     a full length, functional APC protein in patients suffering from FAP and to tests its effect~     on adenoma number and size and on desmoid tumors in these patients. The future goal is to~     maximize the effect of stop-codon suppressors on APC while minimizing side effects.~      In this study investigators will select FAP patients which carry APC nonsense mutations,~     treat them with erythromycin PO for 4-6 months and examine colonic and duodenal adenomas as~     well as abdominal desmoid tumors, that will be documented before during and after treatment.~     In parallel, investigators will test polyp, adenoma and desmoid tissue samples as well as~     blood samples from these patients for changes in expression levels of the APC protein and~     related oncogenic markers.~      Suppression of nonsense mutations within the APC gene should be of benefit for patients~     suffering from FAP, attenuated FAP or multiple adenomas and for patients with advanced or~     diffuse CRC. Furthermore, given the rapid progress being made in the identification of~     different nonsense mutations in human genes that lead to mostly un-curable disease, the~     identification of clinically approved compounds that suppress nonsense mutations and that can~     be administered long-term without significant side effects would open new venues in the~     treatment of genetic human diseases that arise from pre-mature stop codons in important~     coding sequences.~      Immediate goal: establish the ability of erythromycin to read-through APC nonsense mutation~     in FAP patients. The read-through effect of erythromycin will be clinically tested by~     counting and measuring the number and size of both colonic and duodenal adenomas before and~     over treatment and by measuring the size of known desmoid tumors. Samples of the adenomas and~     desmoid tumors will be tested by western blot, immunofluorescence and immunohistochemistry~     for restoration of APC expression and changes in oncogenic markers. These experiments should~     be conducted within 6 month.~      Long term objective:~        1. Determine the lowest dose of erythromycin that can inhibit growth of colonic neoplasia~          and CRC in patients expressing a truncated APC protein due to nonsense mutations.~        2. Examine the ability of a panel of additional macrolide antibiotics to induce APC~          nonsense mutation suppression using in-vitro methods. Investigators will focus on~          macrolide antibiotics that are currently in clinical use and are administrated for long~          terms. These objectives should take around 6 month and will be conducted in parallel.~   "
106100|NCT02178631|"~     Online self-help is an innovative way of providing self-help. The investigators want to study~     the effect of an interactive online self-help-program (Deprexis) in the treatment of severe~     depressive symptoms. Participants will be randomised to either twelve weeks of online-self~     help or a waiting-list control. Symptoms of depression and other aspects will be assessed~     over a six months period. The investigators hypothesise that online self-help is superior to~     the control condition in alleviating depressive symptoms and preventing full blown~     depression.~   "
106101|NCT02178618|"~     Endoscopic retrograde biliary drainage with a self-expandable metal stent (SEMS) has been~     used as a principle palliative method of distal biliary obstruction in patients with~     pancreaticobiliary cancers. With potentially curative surgical resection being impossible,~     the maintenance of successful biliary drainage through patent stent has been regarded as the~     key to improve the quality of life and survival of patient, because it could prevent biliary~     infection or liver failure, and give patients opportunities for anti-cancer chemotherapy~     and/or radiotherapy.~      Although SEMSs have been reported to be superior to large bore plastic stents in terms of~     stent patency, they still have some controversial issues to resolve in relation to stent~     dysfunction and adverse event. It has been widely accepted that covered SEMSs designed to~     overcome the stent failure of uncovered SEMSs related to tumor ingrowth, have significant~     higher rate of stent migration as well as tumor overgrowth. Therefore covered SEMSs did not~     show the clear clinical excellence in the cumulative stent patency over uncovered SEMSs,~     despite some clinical results of randomized trials favor to covered SEMSs.~      From the perspective of adverse events such as pancreatitis and cholecystitis, conflicting~     results have been produced. It was initially assumed that covered SEMSs could cause the~     higher incidence of pancreatitis and cholecystitis attributed to occlusion of pancreatic duct~     and cystic duct by covering materials. However, no significant difference was found with~     regard to the incidence of pancreatitis and cholecystitis between covered and uncovered SEMSs~     in several randomized trials and meta-analysis.~      The aim of the current study is to compare the cumulative stent patency of partially covered~     and uncovered SEMS as a primary objective, and investigate overall patient survival, stent~     dysfunction-free patient survival, and incidence of adverse events including stent~     dysfunction as secondary objectives.~   "
106102|NCT02178605|"~     This prospective study will investigate the use of recombinant human bone morphogenetic~     protein (rhBMP-2) in the current surgical standard of care for cervical spine pathology.~     Specifically, the outcomes of three forms of cervical fusion will be investigated:~        1. Anterior cervical fusion with rhBMP-2, allograft corticocancellous bone as an interbody~          device, and anterior cervical plate fixation.~        2. Posterior cervical fusion with rhBMP-2, local bone graft, with or without posterior~          screw fixation.~        3. A combination of the previous two approaches: a combined anterior-posterior cervical~          fusion with rhBMP-2.~   "
106103|NCT02178592|"~     HIV/Tuberculosis (TB) co-infection have profound effects on the host's immune system. TB is~     the most common cause of death in patients with HIV worldwide. Rifamycins (such as rifampicin~     [RIF]) are an important component of TB therapy because of their unique activity. The problem~     is that most protease inhibitors (PI) and non-nucleoside reverse transcriptase inhibitors~     (NNRTI) used to treat HIV have significant drug-drug interactions with RIF that can lead to~     reduced concentrations of these agents with risk of treatment failure or resistance. The~     non-nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz (EFV) does not present the~     same significant drug interactions with RIF. EFV-based HIV treatment was tested in patients~     concomitantly treated with RIF-containing TB therapy, demonstrating that their~     co-administration can be used safely and effectively. However, the side effect profile of EFV~     overlaps with the RIF-containing TB regimens and makes the management of treatment toxicities~     very complex. Integrase inhibitors (INI), such as dolutegravir (DTG), may offer an important~     alternative to EFV-based therapy in TB coinfected patients. A Phase I drug-drug interaction~     study was conducted in healthy, HIV-seronegative subjects, and showed that DTG at 50 mg twice~     daily given together with RIF was well-tolerated and resulted in DTG concentrations similar~     to those of DTG 50 mg given once daily alone, which is the recommended dose for INI-naive~     patients. Therefore, ART regimens using DTG 50 mg twice daily may represent a new treatment~     option for TB-infected patients who require concurrent treatment for HIV infection. This is a~     Phase III b, randomized, open-label study describing the efficacy and safety of DTG and~     EFV-containing ART regimens in HIV/TB co-infected patients. This study is designed to assess~     the antiviral activity of DTG or efavirenz (EFV) ART-containing regimens through 48 weeks. A~     total of approximately 115 +/-5% subjects will be randomly assigned in a 3:2 ratio to DTG~     (approximately 69 subjects) and EFV (approximately 46 subjects), respectively. This study~     will include a Screening Period, a Randomized Phase (Day 1 to 48 weeks plus a 4-week~     extension), and a DTG Open-label extension (OLE). During the DTG OLE, subjects will be~     supplied with DTG until it is locally approved and commercially available, the subject no~     longer derives clinical benefit, or the subject meets a protocol-defined reason for~     discontinuation, which ever comes first.~   "
106104|NCT02178579|"~     The purpose of this study is to better define and understand potential cardiac toxicity and~     begin to understand optimal management strategies.~   "
106105|NCT02178566|"~     The investigators' hypothesis is that pretreating patients with COPD with inhaled~     treprostinil prior to pulmonary rehabilitation sessions will result in improved exercise~     tolerance during sessions. This in turn will lead to an increased response to pulmonary~     rehabilitation, resulting in improved exercise tolerance and quality of life.~   "
106106|NCT02178553|"~     Unilateral intercostal nerve blocks provide pain control as effectively as a continuous~     thoracic epidural, and will a lower incidence of side effects.~   "
106107|NCT02178540|"~     The purpose of this actual use human factors (HF) study is to validate the approved US TOBI~     Podhaler Instructions for Use (IFU), by establishing that the IFU effectively communicates~     the information necessary to achieve safe and effective use of the Podhaler device.~   "
106108|NCT02178527|"~     This is an exploratory pilot Randomised Controlled Trial (RCT) to investigate the effects of~     a multifaceted podiatry intervention designed to reduce falls in care homes. The~     investigators hypothesise that the intervention will reduce the high falls rates present in~     care homes for older people, compared to usual care.~      The results will inform the sample size calculation for a full-scale definitive RCT~   "
106109|NCT02178514|"~     Our main research question is: Do infants fed with BabyNes Nutrition System grow in agreement~     with the WHO reference?~      Our second question is: Do infants fed with BabyNes Nutrition System have a metabolic profile~     closer to breastfed infants?~      In order to answer both questions an observational trial will be carried out for 12 months in~     order to measure weight and to calculate the weight for age z-scores according to the WHO~     reference.~      A breastfeeding group will be used as reference for the metabolic parameters measured in~     blood of infants from Chinese background.~      The effect of the Babynes formulas will be compared to the metabolic values obtained from~     this breast-feeding reference group.~   "
106120|NCT02178371|"~     The purpose of this study is to assess the functionality of the affected upper limb in~     infantile hemiplegia by applying a protocol of modified constraint-induced movement therapy.~   "
106121|NCT02178358|"~     The main purpose of this study is to evaluate the safety and effectiveness of the study drug~     known as LY2157299 in participants with hepatocellular carcinoma.~   "
106135|NCT02178176|"~     The burden of diabetes is anticipated to grow yet the proportion of adults whose diabetes is~     controlled is decreasing over time. This project can have a significant public health impact~     because we are refining and pilot testing a primary-care based intervention aimed at~     improving patient engagement and function which are critical components of diabetes care and~     are associated with improved glycemic control, lower disease-related health-care~     expenditures, and reduced mortality.~   "
106110|NCT02178501|"~     The major source of mortality and morbidity of diabetic patients is cardiovascular disease~     (CVD). Moreover, in CVD patients the presence of diabetes is associated with the increased~     risk of major adverse cardiac events as compared to patients without diabetes. The~     pathophysiology of macrovascular complications in T2D is not fully understood and involves:~     1/ induction of oxidative stress, 2/ the formation of advanced glycation end products, 3/~     activation of blood coagulation and platelet aggregation, 4/ increased inflammation, 5/~     altered secretion of adipokines in obese subjects and 6/ endothelial dysfunction. All those~     mechanisms in T2D patients could potentially be a subject of new therapeutic interventions.~      A therapy that continues to show promise in T2D patients with CVD is supplementation with~     omega-3 polyunsaturated fatty acids (PUFA). Clinical studies have indicated that omega-3 PUFA~     decrease the risk of major cardiovascular events, although the mechanism of action is not~     completely understood. Moreover, there were no trials exploring the mechanisms and outcomes~     of omega-3 treatment in T2D patients with CVD. Despite that fact, Polish Diabetes Association~     guidelines recommend the use of omega-3 PUFA in patients with diabetes in the prevention of~     macrovascular complications. Moreover, it is unclear whether the benefits of modifying the~     pathophysiological processes during supplementation with omega-3 PUFA occur only in patients~     with their deficiency or in all patients with type 2 diabetes.~      Potential benefits of omega-3 PUFA in such patients are: 1/ decreased oxidative stress, 2/~     decreased platelet aggregation and reduction of hypercoagulable state, 3/ anti-inflammatory~     effects, 4/ improvement in endothelial function. All those effects were explored previously~     with inconsistent findings. There is very limited information from clinical studies on the~     mechanisms and benefits of omega-3 PUFA in T2D patients with CVD.~      The objective of the current study is to evaluate the effects of omega-3 PUFA administered on~     top of optimal therapy of atherosclerotic vascular disease and T2D on endothelial function,~     platelet aggregation and thrombotic, inflammatory and oxidative stress biomarkers.~   "
106111|NCT02178488|"~     The purpose of this study is to treat persistent MRSA carriers with vitamin D supplementation~     during a 12 month to see if the number of MRSA positive patients can be reduced.~   "
106112|NCT02178475|"~     Prospective observational study of febrile neutropenia (FN) and pegfilgrastim primary~     prophylaxis in breast cancer and non-Hodgkin's lymphoma patients receiving high (>20%)~     FN-risk chemotherapy~   "
106113|NCT02178462|"~     A novel blood metabolic biomarker, AminoIndexTM (gynecological), was developed for~     gynecological cancers from over 400 Japanese patient's plasma free amino acid profiles~     (PFAAs) by a rapid and sensitive LC-MS (Liquid Chromatography - Mass Spectrometry), followed~     by multivariate statistical analyses. However, further studies to assess whether this~     biomarker demonstrates the same performance characteristics in non-Japanese populations for~     cancer is yet to be determined.~   "
106114|NCT02178449|"~     The main aim of the study is to investigate the proven effect of dexamethsone on the duration~     of the interscalene block. The investigators try to define optimal dose and volume for~     ropivacaine, when used together with dexamethsone. The current literature uses often very~     high volumes of ropivacain when used together with dexamethasone. The investigators try to~     research the effect of using dexamethsone together with low volume, high concentration~     ropivacaine for interscalene blockade. The investigators' hypothesis is that dexamethasone~     has an positive effect on the pain free after used together with ropivacaine at the scalene~     block.~   "
106115|NCT02178436|"~     This partially randomized phase Ib/II trial studies the side effects and best dose of~     selinexor when given together with gemcitabine hydrochloride and paclitaxel~     albumin-stabilized nanoparticle formulation and to see how well they work in treating~     patients with pancreatic cancer that has spread to other parts of the body. Drugs used in~     chemotherapy, such as selinexor, gemcitabine hydrochloride and paclitaxel albumin-stabilized~     nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by~     killing the cells, by stopping them from dividing, or by stopping them from spreading.~   "
106116|NCT02178423|"~     After the placement of a central venous catheter in children, a routine chest X-ray will be~     performed in order to examine the correct position of the catheter. In this feasibility study~     the investigators intend to evaluate whether the ultrasound is as sufficient as the chest~     X-ray to verify the correct position of the central venous catheter in children with the~     purpose to prevent radiation on children in the future.~   "
106117|NCT02178410|"~     The VITamin D and OmegA-3 TriaL (VITAL) is an ongoing randomized clinical trial of 25,874~     U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000~     IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer,~     heart disease, and stroke in individuals who do not have a prior history of these~     illnesses.The purpose of this ancillary study is to ascertain and adjudicate atrial~     fibrillation (AF) outcomes for the primary aim of testing whether omega-3 fatty acid and/or~     vitamin D supplementation influence atrial fibrillation risk in the general population. We~     also plan to examine how these agents might impact intermediate phenotypes for heart rhythm~     disorders (electrocardiographic parameters), as well as explore effects on arrhythmic death~     and whether baseline blood levels and/or race modify treatment effects.~   "
106118|NCT02178397|"~     The current first line treatment of patients with EGFR activating mutation lung cancer is~     EGFR TKI. Compared to platinum-based chemotherapy, EGFR-TKIs are superior in terms of~     response rate and progression-free survival. However, an acquired resistance occurs almost~     constantly. The second-line treatment includes platinum-based chemotherapy in the absence of~     contraindication. This chemotherapy is then administered after discontinuing EGFR TKIs.~      However, a rebound phenomenon of the disease was described in patients who discontinued EGFR~     TKIs. Some clinical teams therefore recommend, as a precaution, in order to avoid any~     withdrawal phenomenon, to never discontinue EGFR TKIs in patients developing an EGFR TKI~     acquired resistance.~      It seems therefore useful to conduct a study to better define the therapeutic strategy to~     adopt in patients developing an acquired resistance after having received EGFR TKIs as first~     line treatment.~   "
106119|NCT02178384|"~     The two structures that support a mandibular distal extension removable partial denture~     differ markedly in their visco-elastic response to loading. The difference between the~     resilience of the residual ridge tissues and the teeth permitted by the periodontal ligament~     presents a disparity of support that is in contrast to the uniform support accorded a~     tooth-supported removable partial denture. Hence the denture tends to rotate about its most~     distal abutments, inducing heavy torsional stresses on alveolar ridges.~      Many methods have been used to control this movement, some of them:~        1. Implant support on distal extension removable.~        2. Stress breakers provide a mean of interposing a flexible connection between the~          tooth-borne retainer portion of removable partial denture and its distally extended~          tissue-borne segment.~        3. Altered-cast technique.~        4. Design development by using mesial indirect retainers rather than distal ones.~      The purpose of this study is: (1) to compare bone absorption around abutment teeth nearby the~     free saddle; (2) denture displacement and pressure on the soft tissue under the denture base~     of distal extension RPD (Removable Partial Denture) (3) cellular changes in the soft tissue~     under the denture base of distal extension RPD.~   "
106122|NCT02178345|"~     Magnetic resonance imaging (MRI) is a diagnostic technique that takes pictures of organs of~     the body. It uses magnetic fields and radio waves that cannot be felt. Perfusion MRI uses~     faster imaging. It also includes a contrast material that is given by vein. This makes~     specific organs, blood vessels, or tumors easier to see. Diffusion MRI lets us measure the~     motion of water in the tumor.~      Perfusion and diffusion MRI give extra information which is not available with the regular~     MRI. A regular MRI only shows pictures of the tumor. Thyroid MRI scans are not part of the~     current standard of care. The purpose of this study is to see if new MRI methods can give us~     more information about the tumor.~   "
106123|NCT02178332|"~     The purpose of this cluster randomised trial is to investigate whether the Yhteispeli whole~     school programme is effective in improving children's socio-emotional skills and mental~     health and socio-emotional skills.~      All Finnish elementary schools and their classes in 1-3 grades were invited to participate in~     the study. The schools were randomly allocated to receive either Yhteispeli programme or two~     lectures~   "
106124|NCT02178319|"~     Many patients with portal hypertension require surgical treatment each year,and Hassab's~     operation, or esophagogastric devascularization and splenectomy, is an elective procedure. In~     recent years,laparoscopic esophagogastric devascularization and splenectomy has been used to~     treat portal hypertension. However, the potential benefits remain to be demonstrated in the~     context of a randomized trial. In this study, 120 patients will randomize equally receiving~     laparoscopic or open esophagogastric devascularization and splenectomy. Inclusion criteria~     included: platelet count < 50×109/ml, esophageal and gastric varices revealed, agreeing the~     informed consent. PerioperativeOutcomes are: technical success, blood loose and infusion~     during the operation, recurrent varicose veins on gastroscopy examination, patterns of reflux~     on duplex ultrasound examination, complications, platelet and liver function variation,~     length of hospital stay. Follow-up will last 5 years, and gastroscopy and ultrasonic will~     perform at 3 months, 1 year, 3 years, and 5 years. Further more, this study was proved by the~     ethical committee of second hospital of Xi'an jiaotong university.~   "
106125|NCT02178306|"~     To evaluate the safety and efficacy, in particular with regard to renal function of~     telmisartan at the doses of 40 mg and 80 mg in hypertensive patients with moderate to~     endstage renal impairment after 12 weeks of treatment~   "
106126|NCT02178293|"~     A study to in order to verify any differences between the 2 treatment groups in terms of~     duration of analgesic effects after the first drug intake and time to remission of symptoms~     and signs of pharyngitis~   "
106127|NCT02178280|"~     Hilar cholangiocarcinoma is a highly malignant tumor. Surgical resection or simple liver~     transplantation leads to poor prognosis accompanied by high recurrence rate and low survival~     rate. The newly proposed neoadjuvant therapy with liver transplantation strategy shows~     promising clinical application, which once reported 5-year survival rate 82%. However,~     transplantation centers conducting this kind of research are limited due to its complexity~     and long-term. The investigators would like to conduct a clinical trial for only unresectable~     hilar cholangiocarcinoma patients who should take neoadjuvant brachytherapy and~     chemoradiotherapy followed by orthotopic liver transplantation.~   "
106128|NCT02178267|"~     In this study, the investigators investigated the effect of probiotic use on colonization of~     resistant microorganisms in newborn preterm infants receiving antibiotics. This study of the~     use of probiotics in preterm neonates in neonatal intensive care units expect to prevent~     colonization by resistant microorganisms.~   "
106129|NCT02178254|"~     The objective is to determine the safety, tolerability and pharmacokinetics (PK) of 2 single~     doses of ZTI-01 (1g and 8g infused over 1-hr) and a single dose of the Reference Label Drug,~     Monurol® (oral sachet, 3g). Subjects will be randomized to a treatment sequence prior to~     dosing on Day 1 of Period 1 prior to study screening.~   "
106130|NCT02178241|"~     This phase II trial studies how well gemcitabine hydrochloride and eribulin mesylate work in~     treating patients with bladder cancer that has spread to other places in the body or cannot~     be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride and~     eribulin mesylate, work in different ways to stop the growth of tumor cells, either by~     killing the cells, by stopping them from dividing, or by stopping them from spreading.~   "
106131|NCT02178228|"~     The purpose of this study is to identify the cause of leaks that sometimes occur after a~     section of the bowel is removed and reconnected. Certain staplers from the operating room~     will be collected and sent to a third party (ECRI Institute) to be examined for defects. The~     patient's charts will be analyzed for medical issues that may contribute to leaks after~     surgery.~   "
106132|NCT02178215|"~     Atopic dermatitis is a chronic intermittent inflammatory skin disease. Currently, there are~     many cosmeceutical skin products in which their major action affects skin hydration and skin~     barrier function. In addition, there are some herbal medication remedies used for the~     treatment of skin diseases based on the knowledge of Thai traditional medicine. Patients with~     pruritic rash symptoms who attended the Center of Applied Thai Traditional Medicine, Siriraj~     Hospital, were prescribed the Holly Mangrove Shower Gel to use and on the follow-up~     appointment showed significant improvement. Nevertheless, the knowledge of using this herbal~     medication for treating pruritic skin rash so far has been categorized as folk wisdom and not~     been confirmed by any clinical-trial study on its efficacy and mechanism of action.~      Research teams chose Holly Mangrove Shower Gel containing Acanthus ebracteatus Vahl to act as~     adjunctive for treating atopic dermatitis. Thus, for the purpose of studying the efficacy of~     Holly Mangrove Shower Gel containing Acanthus ebracteatus Vahl in improving the skin barrier~     function in atopic dermatitis.~   "
106133|NCT02178202|"~     The purpose of this study was to investigate the effects of HT compared with McK exercise on~     pain and disability in patients with LBP.~   "
106134|NCT02178189|"~     Neonatal abstinence syndrome (NAS) symptoms contribute to poor infant weight gain. Early~     caloric enhancement for infants exposed to methadone is inexpensive, readily available, easy~     to implement and could improve early outcomes for these high-risk infants. We will conduct a~     preliminary randomized clinical trial of high-calorie vs. standard-calorie formula for~     methadone exposed infants to evaluate the adequacy of recruitment, protocol feasibility and~     estimates of whether high-calorie formula results in more normal patterns of weight loss and~     gain, less severe NAS symptoms and shorter hospital stays.~   "
106137|NCT02178150|"~     This is a double-blind randomized clinical trial which will start at June 2014 and end on~     June 2015 in Isfahan city. Serum insulin level is considered as a key variable and the sample~     size calculated 70 persons (35 persons for control group and 35 persons for patient group).~     Patient group will receive magnesium supplement (250 milligram) and the other group will~     receive placebo which is similar to the magnesium tablets in color, odor and appearance both~     for 8 weeks. All subjects will complete 4 physical activity and 4 dietary records. Outcome~     measurements including sex hormone levels, metabolic and inflammatory profiles will be~     measured at the beginning and end of the study as well as anthropetric measurements.~   "
106138|NCT02178137|"~     There has been intensive search for a substance that can have disease-modifying activity for~     osteoarthritis. A number of medications have been reported to be of benefit on slowing~     progression of knee OA. This trial will be the first head to head comparison of these~     medications.~      Patients aged between age 40 to 65 will be enrolled. Patients will be assessed clinically~     using two scoring systems, the WOMAC index for knee arthritis and the SF 36 for overall~     physical and mental health. The knee X rays will be assessed on Kellgren and Lawrence grading~     and will also be measured for joint space narrowing at follow up. The response to arthritis~     medications on slowing down cartilage loss will be measured biochemically with COMP levels.~   "
106139|NCT02178124|"~     Study of the Safety, tolerability and pharmacokinetics with multiple doses of donepezil patch~     in healthy male subjects~   "
106140|NCT02178111|"~     The study hypothesis is that not performing never episiotomies is safe and results are~     equivalent to performing episiotomies ina selective manor.~   "
106141|NCT02178098|"~     This Phase 2 study will assess the efficacy and safety of ETC-1002 monotherapy versus placebo~     in patients with hypercholesterolemia and hypertension.~   "
106142|NCT02178085|"~     Background : Glaucoma is a common disease, potentially blinding, characterized by progressive~     damage to the optic nerve. If the intraocular pressure is the most known risk factor,~     however, there are cases of glaucoma scalable despite well-controlled intraocular pressure,~     ocular hypertension without glaucoma or glaucoma without ocular hypertension (normal tension~     glaucoma).~      Purpose :Involvement of vascular factors in the development of glaucoma and scalability has~     been proved, associated with a possible loss of vascular autoregulation. The objective of~     this study is to quantify MRI flow of blood flows referred ophthalmic patients with glaucoma~     untreated comparison with control subjects.~   "
106143|NCT02178072|"~     The purpose of this study is to assess the activity of 5-azacitidine in patients with Human~     Papilloma Virus (HPV)-positive and HPV- negative head and neck squamous cell carcinoma~     (HNSCC). The response activity will be determined by analyzing your tumor tissue prior to and~     after treatment with 5-azacitidine. Preliminary studies in mice bearing human head and neck~     cancers or head and neck cancer cells cultured in laboratories suggest that treatment with~     5-azacitidine increases changes in cancer cells that lead to their death. This study is~     designed to determine if similar changes occur in cancer cells of patients with head and neck~     cancer.~      The study also aims to determine the amount of a specific type of protein, p53 before and~     after treatment. Research has shown that the p53 protein is associated with anti-tumor~     activity.~      Finally, this study is measuring the amount of a specific type of protein called interferon~     in your tumor tissue. Interferons are proteins made and released by the body in response to~     pathogens (disease causing agents) such as viruses, bacteria, or tumor cells. Interferons~     allow for communication between cells to trigger the protective defenses of the immune system~     that remove pathogens (disease causing agents) or tumors.~   "
106144|NCT02178059|"~     Relative bioavailability study to compare inhalation of Terbutaline Sulphate 1,5mg via~     current version of Turbuhaler with inhalation via a new version~   "
106145|NCT02178046|"~     There is a need for toothpastes that more effectively remove oral plaque and prevent~     re-formation. The objective of this study is to map the development and resolution of~     clinical gingivitis using conventional clinical examination and imaging data to determine how~     useful imaging techniques can be for evaluating how well a toothpaste cleans the teeth~   "
106146|NCT02178033|"~     An adequate level of bowel preparation is crucial for the efficacy and safety of colonoscopy.~     Strong evidences suggest that bowel-preparation quality shows an inverse correlation with~     length of the interval between the end of cleansing agent intake and the start of colonoscopy~     (shorter intervals are associated with better preparation levels). Accordingly, the use of a~     split-dose administration regimen has been demonstrated to significantly improve the quality~     of preparation, besides patient acceptability, as compared with standard administration the~     day before colonoscopy. All randomized controlled trials comparing split versus standard~     preparations were primarily aimed at assessing the quality of colon cleansing, by means of~     either validated or not-validated colon cleansing scales. The impact of a split dose regimen~     on objective colonoscopy performance measures such as adenoma detection rate (ADR) has never~     been specifically and prospectively evaluated.~      The present study is aimed at evaluating whether the split-dose preparation regimen is~     associated with an increase of adenoma detection.~      For this purpose, asymptomatic subjects aged 50-69, undergoing screening colonoscopy for~     positive immunologic fecal occult blood test are randomized in a 1:1 ratio to receive~     low-volume (2L) PEG plus ascorbic acid solution either in a split-dose (study arm) or in a~     full-dose regimen (control arm).~      Treatments are allocated using a computer-generated, randomized code list. The treatment~     allocation is concealed and is accomplished at the screening visit through non-research~     personnel who is not involved in the study. To ensure masking, the endoscopists who perform~     the colonoscopies are not involved in the randomization process and in the pre-procedure data~     collection.~      In this study the the primary outcome measure was the proportion of patients with at least~     one adenoma (Adenoma Detection Rate) in each harm. Data on bowel cleansing, patient~     compliance, tolerability and acceptability were also collected.~      A sample size of at least 514 patients (257 in each arm) was calculated, by hypothesizing a~     relative increase of 25% in the adenoma detection rate in the split dose preparation group,~     assuming a 40% prevalence of one or more adenoma in FIT-positive patients undergoing~     screening colonoscopy (significance level 0.05, 90% power).~   "
106147|NCT02178020|"~     Polyethylene wear and osteolysis remain a concern with the use of modular, fixed bearing~     total knee arthroplasty. A variety of highly cross-linked polyethylenes have been introduced~     to decrease this problem, but there is little data on the results and complications of this~     polyethylene in posterior-stabilized knee prosthesis. The investigators asked the following~     questions: (1) Are there any differences in the clinical and radiographic results when a~     highly cross-lined polyethylene is compared to a standard liner? (2) What is the frequency of~     reoperation in these two groups and are there any specific complications related to highly~     cross-linked polyethylene liners.~   "
106148|NCT02177994|"~     A randomized controlled study comparing the effect of administration of 1 gm ceftriaxone in~     elective cesarean section 30-60 min before skin incision versus after cord clamping.~   "
106575|NCT02172417|"~     Study to investigate the effect of an inhibition of the renal cationic drug transporter on~     single dose pharmacokinetics of intravenous tiotropium in subjects in an age close to typical~     Chronic Obstructive Pulmonary Disease (COPD) population~   "
106149|NCT02177981|"~     Coronary artery disease (CAD) is the leading cause of death worldwide. Patients with severe~     CAD are often treated with coronary artery bypass grafting (CABG). Novel treatment strategies~     need to be pursued to respond to the continuous increase in the risk profile of contemporary~     CABG patients. Surgical myocardial revascularization is commonly performed with the use of~     cardiopulmonary bypass (CPB). Neurological impairment following CABG may take on the form of~     a new-onset motor deficit or postoperative cognitive dysfunction. The former is rare, but~     potentially devastating. Conversely, declines in attention, memory and fine motor skills can~     frequently be documented.~      Ischemic preconditioning is a phenomenon of an endogenous protective response to organ~     ischemia, which is triggered by brief cycles of nonlethal ischemia and reperfusion in tissues~     known to be more resistant to ischemic insults. In clinical practice remote ischemic~     preconditioning (RIPC) is achieved by inflicting short periods of ischemia with intermittent~     restitution of flow to the upper extremity. This intervention has been shown to be effective~     in the reduction of myocardial injury in cardiac surgical patients. The hypothesis tested in~     this research proposal is that RIPC will decrease the extent of postoperative neurological~     injury following CABG.~      In this research project, 70 patients scheduled for an elective CABG will be recruited at a~     single center. They will be randomly allocated to either undergo RIPC (intervention arm) or a~     sham procedure (control arm). Inflating a blood pressure cuff to 200 mmHg for 5 min will~     induce RIPC, thereby inducing a brief period of ischemia. This will be followed by a 5-minute~     arm reperfusion. In total, three cycles of arm ischemia and reperfusion will be induced in~     this fashion.~      All patients will undergo pre- and post-procedural magnetic resonance imaging (MRI) of the~     brain, as well as neurocognitive testing. The array of MRI tools that will be used for the~     quantification of brain injury will include fluid attenuated inversion recovery, diffusion~     weighted and susceptibility weighted imaging, coupled with resting state functional MRI.~      The investigators aim to determine whether RIPC can reduce the adverse impact of CPB on~     neurological outcome as evaluated by MRI detectable brain ischemia and neurocognition.~   "
106150|NCT02177968|"~     The purpose of this study is to identify the prevalence and the characterization of health of~     elderly fallers and non-fallers in the southeastern community of Brazil in the state of São~     Paulo.~   "
106151|NCT02177955|"~     Objective: The aim of the present study was to compare hemodynamic changes using 7.5 mg of~     midazolam and 10.0 mg of diazepam during the surgical removal of symmetrically positioned~     third molars.~      Study design: A prospective, randomized, double-blind, clinical trial was carried out~     involving 120 patients divided in three groups: Group 1 (diazepam and placebo), Group 2~     (midazolam and placebo) and Group 3 (diazepam and midazolam). Each subject underwent two~     surgeries on separate occasions under local anesthesia.~   "
106152|NCT02177942|"~     The effect of supplementation using both protein and multiple micronutrients in preschool age~     children on cognitive performance and growth is unknown. The study will compare the effect of~     combination of protein and multiple micronutrients on indicators of cognitive performance and~     growth in preschool age children. Cognitive performance and anthropometric assessments will~     be measured at baseline and at 6 months.~   "
106153|NCT02177929|"~     The hypothesis is to the fulfillment of canoeing, handbike and conventional physiotherapy~     activities the groups could show improvement in muscle strength of the arms, decreased~     resistance of the lower limbs (spasticity), improved trunk balance and movements of the upper~     limbs, improves cardiovascular function, bone health, and consequently improve the quality of~     life.~   "
106154|NCT02177916|"~     The Lung Transplant Team at Tampa General Hospital has identified a need to improve both the~     quality and quantity of the education that is provided to patients listed for lung~     transplantation. We propose to change the method and timing of our transplant patient~     education. The objective of this prospective data collection will be to collect and analyze~     pre and post test scores of patients when patient education is provided via compact disc as~     compared to individualized teaching.~   "
106155|NCT02177903|"~     The application of active warming to patients whether awake or under general anesthesia has~     been proven safe in numerous studies and it is common practice to use warmers. The warmers~     are commonly used with both the supplied blankets and also with hospital blankets.~      Subjects receiving standard care will not benefit from this study. Subjects in the~     investigational group may benefit in several ways:~        -  Increased comfort in the pre-operative period by being warmer~        -  Decreased incidence of mild hypothermia~        -  Possible decreased incidence of transfusion with less bleeding~        -  Possible decreased pain and discomfort in the Post-Anesthesia Care Unit (PACU)~        -  Possible shorter stay in the PACU and overall Length of Stay (LOS)~        -  Possible decreased risk for surgical site infection~   "
106156|NCT02177890|"~     Nausea is a common and distressing experience that often precedes vomiting. Amongst symptoms~     emanating from the gastrointestinal (GI) tract nausea can be considered somewhat unique, as~     on one hand it represents a normal, highly conserved, physiological response to an ingested~     toxin yet on the other it may indicate pathology. Nausea may also arise as a consequence of~     pharmaco- and chemotherapeutic interventions. Nausea negatively impacts on quality of life,~     adherence to treatment and is a cause for discontinuation of the development of novel~     compounds. Experimentally, nausea can be induced in humans using a visually induced motion~     stimulus. Previously we have developed a 10-minute motion video of the landscape rotating as~     seen from the perspective of a subject standing on Westminster Bridge, London. The tilted and~     rotating view visual display makes the subject perceive that they are spinning round and~     round on a spot tilted away from centre of gravity due to circular vection. This motion video~     induced nausea in approximately 50% of healthy participants and caused a reduction in cardiac~     vagal tone, a validated measure of the parasympathetic nervous system branch on the autonomic~     nervous system. We therefore are evaluating the role of external transcutaneous vagal nerve~     stimulation in visually induced motion sickness.~   "
106157|NCT02177877|"~     This study will assess whether a movement detecting wristwatch can accurately detect seizures~     and seizure characteristics and record them into an online epilepsy diary. The patients may~     manually record a description into the online epilepsy diary of the symptoms they experienced~     before, during or after the seizure.~   "
106158|NCT02177864|"~     The investigators hypothesize that fiber supplementation will provide measurable differences~     in indices of children's health (fewer complaints of abdominal pain and constipation, lower~     body mass index) compared to placebo.~   "
106179|NCT02177591|"~     The prevalence of cardiovascular disease is rising; new methods must be created to assess the~     cardiovascular status of patients. If cardiovascular disease can be predicted, it may~     facilitate prevention. An association between periodontal disease and cardiovascular has been~     established, but a definitive mechanism is not understood. A good first step in finding that~     mechanism is to look at the correlation between periodontal disease and cardiovascular~     disease, both of which have an inflammatory component. This study observes the level of~     cardiovascular disease in patients and correlates it with the presence and degree of~     periodontal pathogens.~   "
106159|NCT02177851|"~     Iron deficiency (ID) with or without anaemia (IDA) is a major public health problem~     worldwide, especially in women of reproductive age and young children. Iron supplementation~     is an effective strategy to prevent and treat ID and IDA. There is a lack of data on iron~     bioavailability from different supplementation regimens and how to optimize bioavailability~     in a cost-effective and patient-friendly way. The daily supplementation with 1-4 mg Fe/kg~     body weight for 3 months is reported to be the most effective method to rapidly increase iron~     stores in subjects with ID and IDA. In IDA patients, medical practitioners often prescribe~     supplementation regimens with 120 mg iron per day split into 2 doses with 60 mg iron, arguing~     that the splitting would increase iron bioavailability compared with one single high dose.~     However, there is no scientific evidence for this assumption; to the contrary, results from a~     recent study suggest that iron bioavailability from a second supplementation dose of iron~     after a first supplementation dose of iron is impaired due to increased hepcidin levels. To~     address this bioavailability issue, the present study will determine iron absorption from 120~     mg iron administered for 3 consecutive days and compare it with that from 2 doses of 60 mg~     iron per day administered for 3 consecutive days. The investigators hypothesize that the iron~     bioavailability from the single daily dose will be lower than that from the 2 doses. By~     measuring also hepcidin, this study will provide important insights on the iron~     bioavailability from a single dose of iron and on the same amount iron split into two doses~     (b.i.d. administration).~   "
106160|NCT02177838|"~     This pilot clinical trial studies cetuximab and radiation therapy in treating patients with~     stage III-IV head and neck cancer. Monoclonal antibodies, such as cetuximab, may block tumor~     growth in different ways by targeting certain cells. Radiation therapy uses high energy x~     rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Giving cetuximab or cisplatin together with~     radiation therapy may kill more tumor cells.~   "
106161|NCT02177825|"~     This phase II trial will test the hypothesis that inhibition of c-kit signalling pathways in~     pediatric patients with Neurofibromatosis Type I(NF-1) and progressing plexiform neurofibroma~     will result in objective reduction and/or inhibition of plexiform neurofibromas progression.~      This will be a Phase II study of imatinib mesylate given orally. Patients with stable or~     responding disease may receive the drug for a period not exceeding one year.~   "
106162|NCT02177812|"~     This study is a phase I, open-label study to determine recommended phase 2 dose (RP2D) and~     regimen for the orally administered lysine specific demethylase 1 (LSD1) inhibitor~     GSK2879552. The recommended dose and regimen will be selected based on the safety,~     pharmacokinetic (PK), and pharmacodynamic (PD) profiles observed after the treatment of~     subjects with relapsed/refractory AML. The study consists of two parts. Part 1 will identify~     the maximum tolerated dose (MTD) and/or RP2D using a dose-escalation procedure. Dose~     escalations will be guided by the Neuenschwander-continual reassessment method (N-CRM). PK/PD~     expansion cohorts will also be included in Part 1 to characterize the range of biologically~     effective doses by assessing PD markers and obtain additional PK data. Part 2 will explore~     further the safety, tolerability, and clinical activity of GSK2879552 at the RP2D in subjects~     with AML.~   "
106163|NCT02177799|"~     Acute gastroenteritis is a common cause of hospitalization in children with significant~     socioeconomic burden on the health community, we will follow in this observational and~     analytical study the admitted cases of acute gastroenteritis to the pediatric floor at the~     Sheikh Ragheb Harb Hospital over a period of summer time to determine the causes, etiologies~     and epidemiology of Age in a community hospital.~   "
106164|NCT02177786|"~     This study will evaluate the efficacy, safety, and tolerability of selonsertib (formerly~     GS-4997) in participants with diabetic kidney disease (DKD). Participants will be randomized~     with a 1:1:1:1 allocation to receive 1 of 3 doses of selonsertib (2 mg, 6 mg, or 18 mg) or~     matching placebo.~   "
106165|NCT02177773|"~     This phase I/II trial studies how well gallium Ga 68-DOTA-TOC positron emission tomography~     (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI) works in imaging~     patients with somatostatin receptor positive tumors. Gallium Ga 68-DOTA-TOC binds to~     somatostatin receptor positive tumors and can be seen using a PET scan. A PET scan uses a~     special camera to detect energy given off from gallium Ga 68-DOTA-TOC, to make detailed~     pictures of areas where material accumulates in the body. Diagnostic procedures, such as~     gallium Ga 68-DOTA-TOC PET/CT or PET/MRI, may help find and diagnose somatostatin receptor~     positive tumors and help plan the best treatment.~   "
106166|NCT02177760|"~     Study Design: SCID infants receiving an unconditioned haploidentical transplant will be~     started on Sirolimus (0.05 mg/kg/day) day -5 for Acute Graft-Versus-Host Disease (aGVHD)~     prophylaxis. Sirolimus levels will be monitored with goal sirolimus trough level of 5-8~     ng/mL. Patients will be monitored for signs of aGVHD as defined by UCSF SOP CL 221.06 through~     day +100. Sirolimus will be tapered once T-regulatory cell to CD4 effector cell ratio is > or~     = 9%.~      Setting: Inpatient BMT Unit Benioff Children's Hospital at UCSF Medical Center~      Study Subjects: 15 infants with diagnosis of maternally engrafted T cells SCID by CA Newborn~     screen receiving unconditioned haploidentical HSCT~      Main Outcome Measures: Incidence of aGVHD (dermatitis, hepatitis, enteritis) as defined by~     SOP CL 221.06 by Day +100.~      Hypothesis 1. Patients placed on sirolimus prophylaxis will have lower incidence of aGVHD~     compared to historical controls.~      Hypothesis 2. Lower doses of sirolimus milligram per kilogram will be required to maintain~     goal troughs of 5-8 ng/mL.~   "
106167|NCT02177747|"~     A subset of 120 diabetic patients underwent dilated examination and smartphone~     ophthalmoscopy. The smartphone was equipped with a compact add-on that filtered and delivered~     the smartphone's LED light coaxially to the camera, allowing a clear and convenient view of~     the retina.~   "
106168|NCT02177734|"~     The purpose of this study is to evaluate the safety and immunogenicity of different~     formulations of GSK Biologicals' H7N9 influenza vaccine in subjects 18 to 60 years of age.~   "
106209|NCT02177201|"~     Postoperative nausea and vomiting is very common in children undergone tonsillectomy and/or~     adenoidectomy. The purpose of this clinical trial is to evaluate the antiemetic effect of~     super-hydration with 0.9% saline in children undergoing specifically elective~     otorhinolaryngological surgery. Fluid intake reduces vomiting as seen following extended~     period of fasting that interrupts the perfusion in gut. Based on this knowledge, we~     hypothesized that administration of supplemental fluid would reduce the incidence of~     postoperative vomiting.~   "
106169|NCT02177721|"~     This field study is designed such that it may be implemented for any individual who has been~     administered raxibacumab for treatment of anthrax or for post exposure prophylaxis including~     sporadic cases, small anthrax incidents and/or a mass event. This study is designed to~     describe the clinical effectiveness (including course of illness and survival), safety~     profile, and raxibacumab pharmacokinetics (PK) from patients who are treated with raxibacumab~     as part of their clinical care following exposure to B. anthracis. Study data and samples for~     PK and other investigational research will be collected prospectively to the extent possible~     at pre-specified time points. However, because of the logistical complexities that would~     likely accompany a mass anthrax event, most data in this study is anticipated to be collected~     retrospectively. During such a mass anthrax event scavenged blood samples will be utilized~     where possible to maximize sample analyses for PK and other investigational parameters.~     Therefore, both retrospective and prospective data collection are allowed in this protocol in~     order to maximize the amount of information obtained in subjects who have been administered~     raxibacumab. This field study will be the first opportunity to collect data on B.~     anthracis-exposed patients treated with raxibacumab, to better understand the clinical~     benefit and safety of the drug and to further inform patient care and treatment choices for~     management of anthrax~   "
106170|NCT02177708|"~     There is increasing evidence that the pathophysiology of hepatic encephalopathy (HE) is~     tightly associated with low-grade cerebral edema. Uptake of ammonia in astrocytes leads to~     osmotic swelling caused by glutamine formation. Previous studies were performed in covert HE~     patients or used indirect methods.~      Methods: The investigators wish to describes quantitative measurement of localized water~     content using MRI water mapping in a cohort of patients with cirrhosis during an episode of~     overt HE type C and again after recovery. Furthermore patients with cirrhosis and no history~     of HE and healthy subjects will be investigated as controls.~   "
106171|NCT02177695|"~     The primary focus of this study is to see if looking at tumor biomarkers using a program~     called coexpression extrapolation or COXEN may predict a patient's response to chemotherapy~     before surgery.~   "
106172|NCT02177682|"~     Afuresertib, an AKT inhibitor, has shown in vitro and in vivo activity in multiple myeloma~     models. AKT inhibitor has also demonstrated encouraging clinical activity in multiple~     myeloma. This study is designed to determine the tolerability, safety, pharmacokinetics and~     efficacy of afuresertib as monotherapy in Japanese relapsed multiple myeloma patients. This~     is an open label, dose-escalating, phase I study. Afuresertib will be given daily until the~     subjects meet any study treatment withdrawal criteria including disease progression. A total~     of up to 24 subjects will be enrolled in the study.~   "
106173|NCT02177669|"~     The contrast sensitivity function (CSF) provides a comprehensive characterization of spatial~     vision and predicts functional vision better than visual acuity, but long testing times~     prevent its psychophysical assessment in clinical applications. Dr. Luis Lesmes et al. (2010)~     developed the qCSF method to obtain precise CSF measurements in only 30-50 trials using a~     computerized software program that presents letters on a large monitor that are identified by~     a patient similar to typical visual acuity testing with an eye chart. The quick CSF method is~     a Bayesian adaptive method that estimates the full shape of the CSF, and the test duration is~     only about 3-6 minutes. Some preliminary testing has been performed at other sites with this~     test in patients with vision loss due to amblyopia and glaucoma, but data from individuals~     without eye disease who have normal visual acuity has not been systematically collected with~     the latest version of this test procedure across a wide range of ages. In addition, we aim to~     gain a better understanding of the typical test-retest variability that is obtained~     between-sessions that are about a week apart from individuals with good ocular health and~     visual acuity.~   "
106174|NCT02177656|"~     This study will test the effectiveness of motivational interviewing and skill building~     compared to usual care to improve self-care in heart failure (HF) patients. The target~     population is HF patients recruited from the Hospital of the University of Pennsylvania after~     an in-patient admission. Patients in the intervention arms will receive one home-visit from a~     nurse who does a self-care intervention followed up by 3 follow-up phone calls.~   "
106175|NCT02177643|"~     Considering that, Diacerein is on the market for almost 20 years, being used continuously in~     elderly patients with osteoarthritis without present significant side effects, and~     considering the anti-hyperglycemic effect and the improvement in the insulin resistance~     observed in animal models of type 2 diabetes and in a previously study from Mexico. The aim~     of our study is to investigate the effect of Diacerein, a medication with anti-osteoarthritic~     properties and moderately analgesic activity, anti-inflammatory and antipyretic, which~     demonstrates inhibit properties for the synthesis of pro-inflammatory cytokines such as~     interleukin 1 (IL-1). Administered for 12 weeks and the effect in the glycemic and metabolic~     control in patients with diabetes mellitus 2 and secondary failure to metformin treatment.~   "
106176|NCT02177630|"~     The purpose of this study is the assess the diagnostic performance of magnetic resonance~     imaging in patients with suspected myocarditis by applying different imaging sequences at~     different MR scanners~   "
106177|NCT02177617|"~     This study aims to compare Botox injections without Physical Therapy sessions to Botox~     injections combined with Physical Therapy sessions for treatment of Cervical Dystonia. It is~     expected that Botox combined with Physical Therapy will improve Cervical Dystonia symptoms~     and quality of life more than Botox alone. It is also expected that Botox combined with~     Physical Therapy will enhance neuroplasticity, or the ability of the brain to make new~     connections, more than Botox alone at 4-5 weeks, and remain improved at 12 weeks, after Botox~     injection.~   "
106178|NCT02177604|"~     Previous research has shown that indulging in 50% more calories than required for as little~     as 3 days can significantly impact markers of metabolic health in lean and overweight~     individuals. Here, the investigators will determine if 3 brief sessions of high-intensity~     interval training can mitigate the adverse consequences of 7 days high-fat overfeeding in~     sedentary, overweight males.~   "
106210|NCT02177188|"~     In prehospital settings, hypovolemic shock diagnosis is based on Advanced Trauma Life Support~     (ATLS) shock classification. The most often used clinical signs are heart rate (HR), arterial~     blood pressure (BP), respiratory rate, neurologic status, diuresis, skin colour and~     temperature. However, some of these signs, such as hypotension and tachycardia, lack~     specificity and sensitivity and do not occur early enough. Even with an early preload~     reduction, blood pressure can remain constant due to compensatory mechanisms, such as~     vasoconstriction and positive chronotropism. Tachycardia occurs earlier, but has poor~     specificity and sensitivity. A retrospective analysis of 25,287 trauma patients showed that~     among 489 patients presenting with systolic BP < 90 mmHg, only 65% had tachycardia (HR > 90~     bpm), while 39% of patients with systolic BP > 120 mmHg were tachycardic, probably resulting~     from other stimuli influencing heart rate, such as pain, fear, circulating hormones and~     endogenous enkephalins. Therefore, it could be very useful to have an index that identifies~     initial volume variation, when physiological regulatory mechanisms are still effectively~     maintaining normal BP.~      Pulse transit time (PTT) is the sum of pre-ejection period (PEP; the time interval between~     the onset of ventricular depolarization and ventricular ejection) and vascular transit time~     (VTT; the time it takes for the pulse wave to travel from the aortic valve to peripheral~     arteries). PEP and VTT variations depend on preload variation, and PTT increases with PEP,~     showing a linear correlation (R2 = 0.96). Chan et al. subjected 11 healthy volunteers to the~     head-up tilt test, and demonstrated that PEP increased and VTT decreased for increasing tilt~     angles from 0° to 80°, corresponding to light-moderate bleeding. They also observed early~     sympathetic activation, expressed by decreases of both RR interval (RR) and VTT, dampening~     the PTT increase, since PTT is influenced by both continuous PEP increase and progressive VTT~     decrease occurring during hypovolaemia.~      Here the investigators describe a new index, called indexed Heart to Arm Time (iHAT). iHAT is~     the mPTT/RR ratio, where mPTT is a modified PTT, measured from the onset of ventricular~     depolarization (the 'R' wave of the ECG trace) to the systolic peak of the~     photoplethysmographic pulse oxymetry (PPG) waveform. mPTT is indexed to RR interval on ECG to~     counteract sympathetic activation that would dampen PEP increase and enhance VTT reduction,~     by means of positive inotropism and peripheral vasoconstriction, respectively. iHAT therefore~     increases during haemorrhage because of preload reduction and the consequent PEP increase and~     RR interval decrease. iHAT is expressed as the time percentage of the interbeat interval (RR)~     it takes to the PPG waveform to travel to peripheral arteries. In this study iHAT has been~     calculated as the average of beat-to-beat mPTT/RR ratios over 30 heart beats (corresponding~     to at least 2 breathing cycles) in order to minimize the effect of spontaneous breathing on~     preload, and thus on PEP and PTT.~      In the present study, the investigators aimed to evaluate iHAT in a simulating model of~     hypovolaemia by using a Lower Body Negative Pressure (LBNP) chamber. LBNP chamber simulates~     haemorrhage by applying negative pressure to the lower limbs, thus giving an accurate model~     of hypovolemia. The LBNP chamber has been used for many years for research purposes, and in~     2001 Convertino suggested it is a useful device to test severe haemorrhage-related~     hemodynamic responses. In fact, the induced volemic sequestration is an efficient technique~     to study physiological behaviours in humans.~      The primary endpoint was to evaluate the use of the iHAT as a predictor of hypovolaemia. The~     secondary endpoint was to compare the specificity and sensitivity of the iHAT index compared~     to commonly used indexes (BP, HR). Furthermore, the investigators aimed to assess feasibility~     of Transthoracic echocardiography (TTE) evaluation of Cardiac Output (CO) in a haemorrhagic~     model and to evaluate CO changes with respect to measured hemodynamic variables.~      TTE evaluation of CO is non invasive and comparable to thermodilution, and of possible use in~     an emergency setting.~   "
106211|NCT02177175|"~     The purpose of this study is to find out the effects, good and/or bad, of a beta blocker~     (carvedilol) on heart function during treatment with anti-HER2 medication(s) including~     trastuzumab (Herceptin).~   "
120968|NCT01984099|"~     A randomized, controlled trial to evaluate the efficacy of methotrexate for the prevention of~     postmolar gestational trophoblastic disease among patients with high-risk hydatidiform mole.~   "
106180|NCT02177578|"~     In this study patients will be treated with 6 weeks of radiation therapy plus temozolomide~     chemotherapy according to the standard of care. However, the radiation treatment plan will be~     modified to deliver an higher than routine radiation dose to the subventricular zone which is~     an area of the brain that contains stem cells that some scientists believe may contribute to~     glioblastoma recurrence. The purpose of the study is to see if the tumor is controlled for a~     longer period of time in patients treated with this modified radiation technique than it is~     in patients treated with standard radiation therapy plus temozolomide chemotherapy.~   "
106181|NCT02177565|"~     Do mesenchymal stem cells accelerate new bone formation in persistent non-unions.~   "
106182|NCT02177552|"~     The main purpose of this study is to determine the effects of treatment with carboplatin,~     docetaxel and capecitabine in patients with incurable cancer of the esophagus or stomach.~   "
106183|NCT02177539|"~     The purpose of this study is to determine whether tropicamide + phenylephrine cyclopentolate~     + applied for once waiting 30 minutes to retinoscopy (new scheme) is not inferior to apply~     cyclopentolate alone and wait 45 minutes to retinoscopy (traditional scheme)~   "
106184|NCT02177526|"~     Management of prostatic carcinoma varies according to stage of disease. Trans-rectal~     ultrasound guided biopsy is known to underestimate the degree of tumor due to undersampling~     and random non-targeted technique. Methods to improve pre-operative tumor localization and~     grading, including multi-parametric (MP) magnetic resonance imaging (MRI) is an active area~     of research but requires further validation.~      High grade tumors can undergo comedo-type necrosis with malignant calcifications which only~     occurs in Gleason pattern 5 tumors and which we hypothesize can be reliably detected using~     computed tomography (CT) and/or MRI.~      Detection of malignant calcification within tumor foci will improve the accuracy of~     localization and grading in prostatic carcinoma.~   "
106185|NCT02177513|"~     Background:~      - Marijuana (cannabis) is an illegal drug. Researchers want to study people s reactions,~     attention, and behavior after they take marijuana in different ways. They want to learn~     better ways to detect drugs in a person s body They also want to know how long marijuana can~     be found in blood, urine, saliva, and breath.~      Objectives:~      - To learn how people respond to delta-9-tetrahydrocannabinol (THC, a marijuana component)~     and how their bodies handle it after it is given in different ways.~      Eligibility:~      - Adults age 18 50 who use marijuana.~      Design:~        -  Participants are screened under another NIDA protocol.~        -  This study involves up to 6 visits to NIDA.~        -  At the first visit, participants will practice the tasks and tests they will do at their~          dosing sessions. They will learn how to give breath and saliva samples.~        -  Dosing sessions 1 4 will last 3 5 days each. All participants will be admitted to a~          research clinic the night before these sessions. Some participants can stay at the~          clinic and some must go home between sessions.~        -  At each session, participants will eat a brownie with placebo or marijuana. Then they~          will smoke a placebo or marijuana cigarette. Some will inhale placebo or marijuana after~          it is vaporized.~        -  Throughout the sessions:~        -  Participants will give urine, saliva, and breath samples. Their blood will be taken with~          a tube in a vein and finger pricks. Their vital signs will be checked.~        -  Participants will answer questionnaires and take thinking tests. They will also take~          tests that assess eye movement, balance, and time estimation.~        -  Participants may have a 5th dosing session. They will eat a marijuana brownie and have~          the above tests and samples.~   "
106186|NCT02177500|"~     An eight week study to compare the effect of a fixed dose combination of Telmisartan 40 mg~     plus hydrochlorothiazide (HCTZ) 12.5 mg to Telmisartan 40 mg alone on diastolic and systolic~     blood pressure in patients who fail to respond adequately to telmisartan monotherapy.~   "
106187|NCT02177487|"~     Study to assess the safety of six month of open-label, treatment with the fixed dose~     combination of telmisartan 80 mg plus hydrochlorothiazide 12.5 mg in a subset of patients~     with mild-to-moderate hypertension who completed the eight week randomized, double blind~     502.261 study.~   "
106188|NCT02177474|"~     In a randomized controlled trial the investigators intended to evaluate the effect of a~     telephone based peer support intervention on depressed or anxious women with coronary heart~     disease (CHD). The investigators intended to include 198 depressed or anxious women aged over~     18 years with CHD. Participants were randomized to intervention (IG) or waiting list (WL). IG~     was offered immediate telephone-based contact to peer counselors while WL received the offer~     with a 6-month delay. All participants got at least one telephone call by a clinical~     psychologist (study information, feedback about the individual level of distress, proposal to~     get help). Main outcome variables were depressive symptoms (PHQ-9) and perceived social~     support (F-SozU K-14). In an additional quasi-experimental trial, the investigators included~     11 peer counselors and 11 matched controls not taking part in the intervention. Main outcome~     variables were mood states (POMS) and perceived social support (F-SozU K-14).~   "
106189|NCT02177461|"~     Study to assess the efficacy and tolerability of Telmisartan 40-80 mg once daily compared~     with enalapril 10-20 mg once daily in elderly patients with arterial hypertension.~   "
106190|NCT02177448|"~     The efficacy and safety of Telmisartan capsule in patients with essential hypertension were~     evaluated in comparison with Enalapril Maleate in the double blind trial.~   "
106191|NCT02177435|"~     Study to demonstrate that a fixed dose combination of telmisartan 80 mg plus~     hydrochlorothiazide (HCTZ) 12.5 mg (FDC 80/12.5) is superior to telmisartan 80 mg (Telm 80)~     alone in patients who failed to respond adequately to Telm 80 monotherapy in lowering seated~     trough diastolic blood pressure (DBP) after eight weeks of treatment.~   "
106192|NCT02177422|"~     The primary objective of this trial was to assess the efficacy and safety of telmisartan 80~     mg during open-label, long-term treatment. An additional objective was to assess the efficacy~     and safety of concomitant administration of telmisartan 80 mg and HCTZ (Hydrochlorothiazide)~     and/or any other therapies commonly used in the treatment of hypertension.~   "
106193|NCT02177409|"~     The primary aim of the trial is the effect of telmisartan versus amlodipine in lowering~     ambulatory diastolic and/or systolic blood pressures in the last six hours of the dosing~     interval in patients with mild-to-moderate hypertension as measured by ambulatory blood~     pressure monitoring (ABPM)~   "
122035|NCT01970150|"~     The purpose of this study is to examine whether the rTMS (repetitive Transcranial Magnetic~     Stimulation) could change cortical excitability measured by off-line EEG in Alzheimer's~     Disease (AD) patients.~   "
106194|NCT02177396|"~     The primary aim of the trial was to compare the effect of telmisartan and valsartan in~     lowering ambulatory diastolic and/or systolic blood pressure in the last six hours of the~     dosing interval. Secondary variables included changes from baseline in diastolic and systolic~     blood pressures during other times during the 24-hour ABPM profile, changes from baseline in~     seated trough diastolic and systolic blood pressures as measured by manual cuff, and~     responder rates. Assessment of safety was also considered. Adverse events and use of~     concomitant therapies were monitored at each study visit. Blood pressure and heart rate were~     collected at each visit. Physical examination, electrocardiograms (ECG) and laboratory tests~     were completed during the trial as well.~   "
106195|NCT02177383|"~     There are conflicting evidences of the effects of dietary supplementation with~     polyunsaturated fatty acids (PUFAs) on athletic performance. The investigators working~     hypothesis is based on the polyunsaturated fatty acids, given its pro-oxidative character and~     also by its action on transcription factors can modulate the antioxidant response and~     oxidative damage induced by physical activity.The overall objective of the study is to~     establish situations improving athletic performance and study the oxidative balance by~     manipulation of feeding patterns and consumption of nutritional supplements and investigate~     the involved mechanisms.~   "
106196|NCT02177370|"~     The aim of the study was to compare the effect of fenoterol metered dose inhaler with~     disodium cromoglycate (DSCG) metered dose inhaler on the lymphocyte β2-receptor population as~     well as on the clinical findings in patients with bronchial asthma over a two-week period of~     treatment.~   "
106197|NCT02177357|"~     The objectives of this study were to evaluate the efficacy, safety, and tolerability of~     pramipexole, as single-agent therapy or in combination with levodopa, in patients with~     Parkinson disease living in Hong Kong and Taiwan.~   "
106198|NCT02177344|"~     The objective of this study is to confirm that chronic dosing of 20 mcg and 40 mcg of~     ipratropium bromide, administered via the RESPIMAT device, demonstrates clinical~     comparability and similar safety profiles to the 36 mcg dose of ATROVENT® Inhalation Aerosol~     (containing chlorinated fluorocarbons (CFC)) in patients with chronic obstructive pulmonary~     disease (COPD). The efficacy and safety profiles of the two doses administered via the~     RESPIMAT device will also be compared to their respective placebo groups~   "
106199|NCT02177331|"~     In order to confirm the proposed metabolic effect of lacidipine these follow-up study was to~     provide long-term data on its impact on liver function, glucose homoeostasis and lipid~     metabolism. Additionally, its adverse drug reactions and antihypertensive effects were to be~     studied.~   "
106200|NCT02177318|"~     To collect post-marketing safety and effectiveness information on the use of Tiotropium~     Inhalation Capsules (18 μg) in patients with chronic obstructive pulmonary disease in daily~     clinical settings~   "
106201|NCT02177305|"~     Safety and tolerability after ocular administration~   "
106202|NCT02177292|"~     The purpose of this study is to find out the effects (good and bad) of using newer~     technologies that allow very precise delivery of radiation. These newer technologies are~     Intensity Modulated Radiation Therapy (IMRT) and Image Guided Radiation Therapy (IGRT).~   "
106203|NCT02177279|"~     There is a lot of evidence to suggest that eating a diet rich in cereals such as wheat bran~     are beneficial in protecting us from diseases such as heart disease, diabetes and cancer. It~     is still not clear exactly why this happens, but it is likely that the compounds which enter~     our bodies when we eat such products are responsible. In this study we plan to find out what~     these compounds are and where they are found. The investigators will do this by asking~     volunteers to eat a wheat-bran meal and then measuring the compounds that appear in blood,~     urine and stool samples over the next twenty-four hours. Once the investigators know how much~     and which compounds are present, we can then find out possible reasons why they are~     protective, for example by looking to see whether they are anti-inflammatory. We also plan to~     look at whether if having a diet which contains either a lot of wheat-bran products or very~     low amounts of these foods effects how they are absorbed by the body.~      HYPOTHESIS: Wheat bran from ready-to-eat cereal has unique phytochemical profiles which are~     metabolized to compounds responsible for high cellular bioactivity imparting important health~     benefits.~   "
106204|NCT02177266|"~     The study will determine the benefit of Colchicine versus placebo for cardiac surgery~     patients on the post-operative development of atrial fibrillation and post-pericardiotomy~     syndrome.~      Primary Objective. Colchicine will reduce the composite endpoint of incidence of~     post-operative atrial fibrillation and post-pericardiotomy syndrome at 3 months following~     cardiac surgery.~      Secondary Objectives.~        1. Colchicine will reduce the incidence of constrictive physiology on echocardiography at 3~          months following cardiac surgery.~        2. Reduction in the burden of symptomatic and asymptomatic atrial fibrillation in the 3~          months following cardiac surgery with the use of colchicine.~   "
106205|NCT02177253|"~     The primary objective of this study was to compare the long-term (12-week) bronchodilator~     efficacy and safety of ipratropium bromide / salbutamol combination administered by the~     Respimat® 40 mcg / 200 mcg (one inhalation q.i.d.) to COMBIVENT Inhalation Aerosol (two~     inhalations q.i.d.), ipratropium bromide Respimat® (one inhalation q.i.d.) and Placebo~     formulations of each in patients with Chronic Obstructive Pulmonary Disease (COPD). An~     additional objective was to show the superiority of Combivent Respimat as compared to~     ipratropium bromide (40 mcg) Respimat. Steady state pharmacokinetics over one dosing interval~     following four weeks of therapy were also characterized.~   "
106206|NCT02177240|"~     The purpose of this study is to determine if the Flex-it® Articulating Stylet or the~     GlideRite® Rigid Stylet is more effective and less traumatic in the context of difficult~     GlideScope® intubations.~   "
106207|NCT02177227|"~     The purpose of our study is to determine, using a prospective, randomized-controlled trial,~     the economic viability and clinical outcomes associated with patient-specific instrumentation~     (PSI) for total knee arthroplasty in an obese patient population.~   "
106208|NCT02177214|"~     Purpose of the study is the visualization of the mesh and the determination of the mesh~     surface observed by MRI at 3 weeks and 13 months after ventral hernia repair with mesh~     visible IPOM (Dynamesh®). We want to prove that with this type of mesh it is possible to~     visualize the mesh position in vivo in a safe manner. This provides long-term benefit to~     early recognize possible recurrence caused by shifting or shrinking of the mesh and to~     provide early treatment.~   "
106212|NCT02177162|"~     Physiotherapists' knee OA care is suboptimal. Exercise therapy including a combination of~     aerobic, muscle strengthening and functional exercises is not always performed and a lot of~     treatments are used for which there is no evidence. By a continuing education session and a~     pop-up in the electronic patient file, this study wants to improve knee OA care by focusing~     on combined exercise therapy.~      The study will be performed in collaboration with Pro-Q-Kine, an independent organization~     implementing quality improvement in Belgian physiotherapists' care. Besides Pro-Q-Kine the~     study will be performed in collaboration with two or three software producers of~     physiotherapists' electronic patient files that reached a national homologation for their~     respective software packages and covering a large part of the Flemish physiotherapists.~      Pro-Q-Kine will organize sessions of continuing education with a focus on optimal knee OA~     care. These sessions will be performed in LOK-groups (local peer-groups of physiotherapists~     who meet each other for continuing education). At these sessions the physiotherapists will be~     asked to take part to the study. A pop-up will be installed in the electronic patient file of~     the participating physiotherapists, lightening up when physiotherapists register a patient~     with knee OA. The pop-up includes a short message about optimal knee OA care. The~     physiotherapists will also receive a script for a query in their electronic patient files in~     order to extract those patients that initiated a treatment for knee OA between 1 year and 3~     months before the therapists received education. These patients will receive a letter of~     their respective physiotherapists in which they are addressed to take part to the study. An~     informed consent, patient questionnaire and retour-envelope will be included. There will also~     be the opportunity to complete the questionnaire electronically with an electronic informed~     consent. The patient questionnaire will include some background details (such as age and~     gender) and details about the physiotherapeutic treatments they received for knee OA. The~     patient questionnaire will be coded with a number, referring to the physiotherapist and to~     the individual patient (the first patient of the first physiotherapist will be coded as 1.01,~     the 10th patient of the 14th physiotherapist will be coded as 14.10). Patients' names will~     not be revealed to the investigators and physiotherapists will not have any access to the~     completed patients' questionnaires. The general practitioners in the environment of the~     physiotherapist will (probably) receive a letter from the researchers. This letter will~     contain information about the importance of referral to a physiotherapist in knee OA care and~     about knee OA care in general. This letter will also refer to the study that is going on in~     physiotherapists' care, without details.~      Six months after the installation of the pop-up, the physiotherapists will be asked again to~     perform the query to extract patients out of the electronic patient file that have been~     treated for knee OA and whose treatment sessions had been started in the period of three~     months from the installation of the pop-up.~   "
106213|NCT02177149|"~     The central hypothesis is that the use of a DBS (Deep Brain Stimulation) clinical decision~     support system for individual patient management will enable considerable time savings~     compared to standard care. This hypothesis was formulated from pilot studies that showed~     dramatic decreases in DBS programming time compared to standard care for clinicians who used~     an iPad-based decision support system (99% time savings from over 4 hours to 2 minutes. Study~     group Parkinson's patients with DBS Systems~   "
106214|NCT02177136|"~     This is a phase 2, double-blind, placebo controlled trial in patients with primary sclerosing~     cholangitis to evaluate the effect of obeticholic acid on liver biochemistry, in particular,~     serum alkaline phosphatase; and, safety.~   "
106215|NCT02177123|"~     The purpose of this study is to collect additional safety and effectiveness data on the~     InnFocus MicroShunt (MIDI Arrow) in subjects suffering from primary open angle glaucoma who~     are inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥~     18 mm Hg and ≤ 35 mm Hg and/or where glaucoma progression warrants surgery.~   "
106216|NCT02177110|"~     This is an exploratory prospective translational multicentre study. Melanoma is the 5th most~     common cancer diagnosed in Ireland and its incidence among women and men is above the~     European average.~      Following treatment the elimination of cancer cells ultimately occurs by the activation of~     apoptotic cell death pathways. The SYS-ACT approach builds on a combination of mathematical~     systems of modelling, quantitative biochemistry and cell biology, and specifically predicts~     the drug responsiveness of melanoma cell lines to various apoptosis-inducing treatments.~      The investigators propose to validate the SYS-ACT approach and application in a translational~     systems medicine study.~   "
106217|NCT02177097|"~     Revision surgery after total hip or knee arthroplasty is an ongoing issue due to an~     increasing number of primary surgeries. Patients seek physicians due to pain. The cause is~     divided between loosening, infection or chronic pain. Some are operated on the suspicion of a~     chronic infection. However, postoperative microbiological testing does not always correlate~     with the suspicion and the operation may have been superfluous.~      The objective is to employ a highly advanced diagnostic algorithm based on state of the art~     diagnostic techniques in order to improve the basis of preoperative diagnosis. Through this~     approach treatment can be given according to the causal problem.~   "
106218|NCT02177084|"~     The study aims to evaluate the efficacy of percutaneous tibial nerve stimulation (PTNS)~     associated with conservative therapy (arm A) for the treatment of low anterior resection~     syndrome (LARS) compared with only conservative therapy (arm B).~      The secondary aims are the evaluation of the following parameters:~        -  Effect of PTNS on manometric parameters~        -  Effect of PTNS on quality of life~        -  Effect of PTNS on the severity of fecal incontinence and / or obstructed defecation~        -  Safety of PTNS~   "
106219|NCT02177071|"~     Phase IV~      Design : Prospective, open-label, randomized three-arms study~      Main Inclusion criteria Luminal Crohn's disease patients with steroid free remission for at~     least 6 months and a combination therapy with infliximab and anti-metabolites for at least 8~     months~      Primary objective To demonstrate that Infliximab scheduled maintenance with or without~     antimetabolites is superior to antimetabolites alone to maintain sustained steroid-free~     remission over 2 years, while the latter is non inferior with regards to the mean time spent~     in remission over the same duration~      Main co-primary end points Clinical relapse rate at 2 years Mean remission duration within 2~     years Study treatment Infliximab, Mercaptopurine, azathioprine, methotrexate.~      Number of subjects 300 randomized patients (100 per arm)~      Study duration: 2 + 2 years Enrollment: 2 years + 1 year Follow-up: 2 years~   "
106220|NCT02177058|"~     This project directly addresses the national imperative for innovative strategies to improve~     care for Medicare beneficiaries and reduce health care costs. The overall objective of the~     proposed project is to improve the care of older individuals who reside in nursing homes~     (NHs), and at the same time reduce unnecessary Medicare expenditures. This goal will be~     accomplished by testing a quality improvement program designed to reduce the number of~     avoidable hospitalizations of NH residents in a randomized controlled trial.~      The primary hypotheses to be tested are:~      Hypothesis1: Interventions to Reduce Acute Care Transfers (INTERACT) implementation NHs will~     have a greater reduction in hospitalization rate than the control and monitoring only NHs~     during the 12-month implementation compared to a 12-month baseline period.~      Hypothesis 2: Reductions in Medicare expenditures for hospitalizations in the INTERACT~     implementation NHs will be greater than the estimated costs of implementing the intervention.~      Hypothesis 3: The effects of INTERACT on hospitalization rates will be greater among patients~     on the Medicare skilled benefit for post-acute care, than for long-stay patients.~      Hypothesis 4: The effects of INTERACT on hospitalization rates will be greatest among those~     NHs with higher vs. lower intensity (fidelity) of implementing the program.~      Hypothesis 5: There will be a greater reduction in measures of hospitalizations for~     conditions defined as potentially preventable than for other transfers and~     hospitalizations.~      Hypothesis 6: Implementation of INTERACT will not be associated with worsening of relevant~     quality measures in the participating NHs.~   "
106221|NCT02177045|"~     Breast lesions are a common condition, diagnosed by imaging and palpation. In order to reduce~     the number of biopsies performed to the definitive diagnosis of a breast lesion, an imaging~     method with a high degree of accuracy is needed. Ultrasound imaging with microbubbles~     contrast media allows the diagnosis of vascularization of the lesion, according to timing.~     Our hypothesis is that a highly vascularized lesion that enhances in an early timing is most~     likely to represent a malignant lesion and thus, deserves biopsy for a definitive diagnosis.~     Females over 18 years age, with a focal lesion in breast will be suitable to perform this~     examination.~   "
106222|NCT02177032|"~     Demonstrate non-inferiority of the immune response between new versus the currently~     recommended intradermal regimens of rabies vaccine when administered with or without rabies~     immunoglobulins in healthy subjects ≥ 1 years of age.~   "
106223|NCT02177019|"~     The research project is a component of a mentored research career enhancement award. The~     purpose of the award is to help the PI and his collaborators prepare for future research~     grant opportunities through the Patient Centered Outcomes Research Institute (PCORI). The~     research project is a feasibility study with the following specific aims; 1) to assess~     outcomes associated with a personalized health plan for frequent headaches; 2) to identify~     measurable outcomes that are meaningful to patients with frequent headaches; and 3) to create~     a patient stakeholder group to inform patient-centered outcomes research for frequent~     headaches. Specific Aim #1 will be achieved by recruiting and enrolling 40 established~     patients at the Duke Family Medicine Center who have frequent headaches. The intervention~     consists of 3 study visits with the PI, 2 clinical consultations with subjects' established~     primary care provider at the Duke Pickens Family Medicine Center, and participation in 2~     focus groups. Personalized health plans might consist of a combination of medical management,~     lifestyle changes, nutrition counseling, or other therapeutic modalities as appropriate. Data~     analysis will be descriptive; no formal hypotheses will be tested.~   "
106224|NCT02177006|"~     Childhood exposure to high levels of sunlight is a strong determinant of melanoma risk.~     Pediatric clinicians can provide important sun protection counseling. In 2003, the United~     States Preventive Services Task Force determined that clinician counseling has an effect on~     use of sunscreen for children but not for other sun protection measures such as protective~     clothing, or reducing sun exposure. Regular sunscreen use prevents melanoma development in~     adults as well as nevi in children, but reliance on sunscreen as the only form of sun~     protection is problematic.~      This novel research seeks to develop a sun protection program that is feasible for pediatric~     clinicians to deliver with patient-centered messages and systems to support program~     implementation in the clinical offices. The sun protection messages will enable behavioral~     change by the stakeholders (caregivers and children) that will reduce painful sunburns in the~     children and eventually reduce the incidence of melanoma. Testing the feasibility of~     delivering the intervention in a pediatric practice will enhance the sustainability of the~     intervention, and lead the way to dissemination of good practice.~      This proposal seeks to develop and test an intervention that seeks to improve sun protection~     of young children. The intervention includes two phases:~      Phase 1: From June to August 2014, a voucher to obtain a swim shirt for sun protection~     provided by the Pediatric Sun Protection Foundation will be affixed to the anticipatory~     guidance sheet provided by the practice to caregivers of children 2-6 years of age.~      Phase 2: Analysis of online redemption of vouchers in comparison with the self-reported~     surveys~      We hypothesize that redemption of the vouchers will be associated with the perception of the~     child having sun sensitive skin.~   "
106225|NCT02176993|"~     The investigators goal is to improve the outcome of patients with acute stroke by inducing~     mild cerebral hypothermia through surface cooling at the cervical and shoulder regions using~     EMCOOLS Brain.Pads®.~      For this project, the investigators can build further on their research group's experience~     with hypothermia in animal models and invasive cooling in stroke patients.~      The COOL program will prospectively evaluate safety, feasibility, patient acceptance and~     efficacy of mild cerebral hypothermia using EMCOOLS Brain.Pads® in a large cohort of patients~     presenting with acute stroke at the Emergency Department of the Universitair Ziekenhuis~     Brussel. The application of EMCOOLS Brain.Pads® will be compared to routine clinical practice~     in a randomized controlled trial. If proven to be safe, feasible, well-tolerated and~     efficacious in the inhospital setting, future use in prehospital acute stroke care will be~     incorporated with telemedicine support, as part of the Prehospital Stroke Study at the~     Universitair ziekenhuis Brussel (PreSSUB).~   "
106226|NCT02176980|"~     Subjects are being asked to take part in a research study to test two levels of alcohol~     services for patients with hepatitis C virus (HCV) who drink alcohol. The two levels differ~     in intensity of alcohol services and in whether or not they include a focus on liver health.~     The study will look at which level of alcohol services best decreases alcohol use among~     patients with HCV.~   "
106227|NCT02176967|"~     This phase III trial studies how well response and biology-based risk factor-guided therapy~     works in treating younger patients with non-high risk neuroblastoma. Sometimes a tumor may~     not need treatment until it progresses. In this case, observation may be sufficient.~     Measuring biomarkers in tumor cells may help plan when effective treatment is necessary and~     what the best treatment is. Response and biology-based risk factor-guided therapy may be~     effective in treating patients with non-high risk neuroblastoma and may help to avoid some of~     the risks and side effects related to standard treatment.~   "
106228|NCT02176954|"~     The aim of this study is to investigate the influence of the adhesive wafer design on the~     products ability to fit to the body..~   "
106243|NCT02176746|"~     Most studies of cancer stem cells (CSC) involve the inoculation of cells from human tumors~     into immunosuppressed mice, preventing an assessment on the immunologic interactions and~     effects of CSCs. In this study, the investigators examined the vaccination effects produced~     by CSC-enriched populations from histologically distinct murine tumors after their~     inoculation into different syngeneic immunocompetent hosts. Enriched CSCs were immunogenic~     and more effective as an antigen source than unselected tumor cells in inducing protective~     antitumor immunity.Immune sera from CSC-vaccinated hosts contained high levels of IgG which~     bound to CSCs, resulting in CSC lysis in the presence of complement.CTLs generated from~     peripheral blood mononuclear cells or splenocytes harvested from CSC-vaccinated hosts were~     capable of killing CSCs in vitro. Mechanistic investigations established that CSC-primed~     antibodies and T cells were capable of selective targeting CSCs and conferring anti-tumor~     immunity.~   "
106229|NCT02176941|"~     The prevailing view in telomere epidemiology is that leukocyte telomere length (LTL) is~     associated with atherosclerosis and accelerated aging since it serves as a biomarker of the~     cumulative burden of inflammation and oxidative stress during adult life. Our recent results~     however, indicate that telomere length (TL) is mainly determined at birth and childhood.~     Since short telomeres ante cede atherosclerosis, the investigators hypothesize that TL is not~     just a simple marker, but a real determinant of arterial aging. That is because TL reflects~     cellular repair capacity and a short LTL denotes diminished repair reserves. This hypothesis~     cannot be tested by measurements of LTL alone, since this parameter reflects TL at birth and~     its age-dependent attrition thereafter. The investigators propose, therefore, a model that~     makes it possible to examine different elements of TL dynamics in different tissues:~     leukocytes, skeletal muscle, endothelial progenitor cells (EPCs), skin or subcutaneous fat in~     patients with or without atherosclerosis.~      Our model is based on the following premises, which are derived from observations that TL is~     synchronized (equivalent) across somatic tissues/cells of the newborn:~        -  TL in skeletal muscle mainly reflects TL at birth~        -  The difference in TL between muscle and leukocytes in adults (approximately 1.5 Kbp)~          mainly reflects LTL attrition during the growth period, i.e., childhood/adolescence~        -  TL in EPCs determines the cell proliferative ability and therefore capacity for vessels~          repair during aging.~      The general aim of the present project is to examine the links of arterial aging with TL, as~     expressed in different tissues, and LTL dynamics, as expressed in the difference between TLs~     of muscle and leukocytes.~   "
106230|NCT02176928|"~     The purpose of this study is to examine impact of Sleep Disordered Breathing (SDB) treatment~     in persons with chronic Spinal Cord Injury (SCI). The central hypothesis is that the~     treatment of SDB with Positive Airway Pressure (PAP) will improve cognition, sleep quality,~     health related quality of life (HRQOL), pain and Cardiovascular Disease (CVD) surrogate~     measures in persons with chronic SCI.~   "
106231|NCT02176915|"~     The Fresh Start postpartum weight loss program will test the effectiveness of a group-based~     weight loss intervention that includes videos featuring peers who have successfully achieved~     postpartum weight loss. The group-based condition will be compared to a control condition~     involving print materials related to weight loss.~   "
106232|NCT02176902|"~     This randomized phase II trial will evaluate if a low-fat diet with fish oil has the~     potential to delay disease progression in patients with prostate cancer undergoing active~     surveillance.~   "
106233|NCT02176889|"~     The purpose of this study is to determine whether Lactospore is safe in healthy adults.~   "
106234|NCT02176876|"~     This study is to assess the safety, tolerability, and pharmacokinetics (PK) of multiple~     infusions of GS-5745 in adults with rheumatoid arthritis (RA). Participants will be~     randomized in a 4:1 ratio to receive 1 intravenous (IV) infusion of GS-5745 or placebo every~     2 weeks, for a total of 3 IV infusions.~   "
106235|NCT02176863|"~     This is a multicenter, prospective, randomized, placebo-controlled, double-blind, parallel~     group clinical trial with adaptive dose selection in subjects with post polio syndrome (PPS).~      The main purpose of this study is to select a dose of Flebogamma 5% DIF and confirm the~     efficacy of the selected Flebogamma 5% DIF dose by assessing physical performance, as~     measured by 2 Minutes Walk Distance (2MWD) test.~   "
106236|NCT02176850|"~     This post-marketing surveillance study was designed to supplement under conditions of normal~     clinical practice the data on the safety, tolerability and efficacy of Micardis® collected~     during the clinical studies.~   "
106237|NCT02176837|"~     The hypothesis is that intravenous infusion of sodium nitrite is safe and effective for the~     reversal of cerebral vasospasm after subarachnoid hemorrhage in patients with a cerebral~     aneurysm.~   "
106238|NCT02176824|"~     Chronotherapy is a term that describes therapeutic alterations of sleep wake cycles.~     Different variations of sleep deprivation, set sleep wake schedules, and types of light~     therapy have demonstrated efficacy in rapidly treating depression, and suicidal thinking.~     This study seeks to explore the effect of two different chronotherapuetic protocols on~     acutely depressed and suicidal inpatients admitted to the Medical University of South~     Carolina~   "
106239|NCT02176811|"~     The study searched for answers to two questions:~      1-What are the plasma betatrophin levels in subjects with non-alcoholic fatty liver disease~     and healthy controls.~      2. Is there any relationship between plasma betatropin levels and different stage of~     non-alcoholic fatty liver disease 2.Is there any relationship between plasma betatropin~     levels and metabolic parameters in subjects with non-alcoholic fatty liver disease.~   "
106240|NCT02176785|"~     Transcranial Direct Current Stimulation (tDCS) is a safe, non-invasive brain stimulation~     technology that has demonstrated the ability to temporarily increase or decrease activity in~     specific regions of the brain. The researchers are investigating the effect of this~     technology on sleep propensity by applying two different types of stimulation as well as sham~     (Placebo) stimulation during three different afternoon naps. The researchers are subsequently~     hoping to recruit healthy volunteers without medical, or sleep problems who have a regular~     sleep schedule to participate in the study~   "
106241|NCT02176772|"~     Background: The disease burden of tuberculosis (TB), second only to HIV/AIDS among infectious~     diseases, is a major public health problem in developing countries. Accumulating evidence~     suggests that iron status is a primary determinant of TB progression. Anaemia is prevalent in~     patients with TB, particularly in sub-Saharan Africa, and associated with increased~     mortality. Anaemia in TB may be due to inflammation, dietary iron deficiency, or both, and~     distinguishing among these aetiologies is difficult. Iron supplementation is commonly used to~     treat anaemia in TB patients, but may be unnecessary if inflammation is the cause. Body iron~     sequestered by TB inflammation can be mobilized during treatment and used to correct the~     anaemia. Moreover, supplemental iron may be retained within macrophages, potentially~     increasing susceptibility to TB and leading to a poorer clinical outcome. Thus, better~     understanding of iron metabolism during TB and the aetiology of TB-related anaemia would~     clarify the potential role of iron in pathogenesis and optimal management of the disease.~      The investigators hypothesize that: a) TB will increase circulating hepcidin and thereby~     impair dietary iron absorption and systemic utilization of iron, resulting in iron~     sequestration and anaemia; b) TB treatment and resolution of inflammation over 6 months will~     decrease circulating hepcidin, correcting these impairments and improving iron status and~     hemoglobin; c) the majority of iron utilized to replenish hemoglobin during recovery from TB~     will come from mobilization of sequestered iron stores rather than from iron absorption.~      Objectives: Use iron stable isotopes to characterize iron balance over six months of TB~     treatment, and specifically to: a) quantify oral and intravenous iron incorporation (oral~     absorption and systemic iron utilization) at three time points during TB treatment (acute~     disease, after the intensive treatment phase and at completion of the continuation treatment~     phase); and b) determine the effect of treatment on iron mobilization from stores to~     replenish hemoglobin.~      Methods/Subjects: Using a triple stable-isotope technique, iron absorption from labelled test~     meals (57Fe) and systemic iron utilization after labelled intravenous doses (54Fe, 58Fe) will~     be determined in 18 Tanzanian subjects with newly diagnosed pulmonary TB. The subjects will~     be studied at three time points (i) the day after TB diagnosis while infected, (ii) after 8~     weeks of intensive phase treatment, and (iii) after another 16 weeks of continuation phase~     treatment. Iron status, hemoglobin, hepcidin and inflammation indexes will be measured at~     each time point. Isotope enrichment during the two treatment phases will be measured to~     estimate the relative rates of iron absorption and mobilization from stores during the~     intensive and continuation phases to determine the relative contributions of iron absorption~     and iron mobilization from stores during TB treatment and recovery.~      Outcome: These studies will provide important new insights into the aetiology of anaemia and~     iron metabolism in TB patients. The results will provide essential data for evidence-based~     recommendations on the timing, administration route and efficacy of iron therapy in patients~     with TB, making possible, a safer and more effective treatment of anaemia in TB while~     decreasing morbidity and mortality from the disease.~   "
106242|NCT02176759|"~     Ferric pyrophosphate (FePP) is a water-insoluble, food grade iron compound used to fortify~     rice, infant cereals and chocolate-drink powders as it causes no organoleptic changes to the~     food vehicle. However, it is only of low absorption in man. Therefore, strategies to enhance~     the bioavailability of FePP, such as adding citrate or decreasing the particle size of FePP~     need to be investigated. The primary objectives of the present study are: 1) to test whether~     the presence of citrate in iron fortified rice with FePP results in higher iron~     bioavailability, and 2) to test whether the presence of citrate in the rice grain during the~     extrusion and cooking process results in higher iron bioavailability compared with~     iron-fortified rice where citrate has been added shortly before consumption. As a secondary~     objective the investigators will compare the absorption from different FePP combinations with~     a reference meal fortified with ferrous sulphate. The investigator hypothesize that the~     addition of citrate enhances iron absorption and that the positive effect is greater when the~     citrate is added during the extrusion.~      The investigator will conduct an iron absorption study in 20 women, 18 to 45 years old to~     evaluate the iron bioavailability from extruded rice fortified with 1) regular FePP, 2)~     regular FePP and citrate (both extruded into the rice kernels), 3) regular FePP and citrate~     added at the time of consumption, and 4) from normal rice fortified with ferrous sulphate at~     the time of consumption. Iron absorption will be measured as erythrocyte incorporation of~     stable iron isotopes at least 14 days after the administration of the isotopically labelled~     test meals. The iron absorption from the different meals within the same participant will be~     compared by repeated-measures ANOVA followed by a Bonferroni corrected pairwise comparison.~      The present study will provide important data where iron bioavailability from rice is~     accurately and directly measured using stable isotopic labels as absorption tracers. This~     direct data can be used to base decisions on the level of fortification, can potentially~     reduce costs and optimize iron delivery to the targeted population in iron fortification~     programs.~   "
106244|NCT02176733|"~     The Leber Hereditary Optic Neuropathy is a genetic disorder caused by maternal transmission~     of mitochondrial DesoxiroboNucleid Acid mutations. It is manifested by a rapidly progressive~     blindness, profound, due to atrophic optic nerve. The visual loss is primarily unilateral~     bilateralisation taking place in the vast majority of cases in weeks or months. The~     neuro-cardio-protective properties of cyclosporine (and its analogs specifically targeting~     the anti-apoptotic mechanisms) are particularly promising.~      The investigators hypothesis is that cyclosporine may limit apoptosis during the acute phase~     of the disease process and would limit the loss of visual acuity and improve the visual~     prognosis of these patients.~   "
106245|NCT02176720|"~     It was previously shown that [18F]Fluorodopa (FDOPA) PET imaging results in intended~     management changes in 41% of brain tumor patients. However, its impact on patient outcome~     defined as survival, costs, and/or quality of life has not been demonstrated. Regulatory~     agencies require randomized trials to determine the impact of PET on patient management and~     outcome. In this study we hypothesize that the addition of FDOPA PET will improve patient~     outcome by more accurately identifying presence or absence of tumor recurrence than~     conventional imaging.~   "
106246|NCT02176707|"~     As there are no validated tools for assessing patient reported outcomes or health related~     quality of life in idiopathic pulmonary fibrosis (IPF), different studies have utilised~     different methods. This means that comparison of the outcomes of studies is difficult or~     inaccurate. By collecting different quality of life tools and patient reported outcome at the~     same time, it will be possible to map or model the results of one tool or groups of tools~     onto another. 250 patients with IPF will be asked to complete the EuroQoL 5D, Kings Brief~     Interstitial Lung Disease questionnaire, St George's Respiratory Questionnaire, MRC dyspnoea~     scale, University of California, San Diego shortness of breath questionnaire and the Hospital~     Anxiety and Depression Scale, along with spirometry every 3 months, and undergo a 6 minute~     walk test every 6 months, over a 12 month period. Prognostic models will be constructed from~     all the clinical (questionnaire and function) measures a linear regression model.~   "
106247|NCT02176694|"~     A randomized controlled trial of a texting intervention to increase adherence to preventative~     asthma medication in four Cincinnati Children's Hospital Medical Center primary care clinics.~   "
106248|NCT02176681|"~     Diabetes is a major concern for dialysis units, as it is now the most common cause of~     end-stage renal disease in France. In 2010 at initiation of dialysis treatment, more than one~     patient out of two had at least one cardiovascular disease and 40 % diabetes (94 % Type 2~     diabetes) and especially in East part of France.~      Diabetic patients on dialysis have a high burden of morbidity and mortality, particularly~     from cardiovascular disease. Tight glycaemic and blood pressure control in diabetic patients~     has an important impact in reducing risk of progression nephropathy. Data are scarce on how~     diabetes should best be treated in dialysis patients. The evidence for improving glycaemic~     control in patients on dialysis having an impact on mortality or morbidity is sparse. Indeed,~     many factors make improving glycaemic control in patients on dialysis very challenging,~     including therapeutic difficulties with hypoglycaemic agents, monitoring difficulties,~     dialysis strategies that exacerbate hyperglycaemia or hypoglycaemia.~      Standard oral drugs therapy for hyperglycaemia (eg, metformin, sulfonylureas, ) are~     contraindicated in patients on dialysis. Thus insulin has been the mainstay of treatment.~     Newer therapies for hyperglycaemia, such as gliptins and glucagon-like peptide-1 analogues~     have become available, but until recently, renal failure has precluded their use. Newer~     gliptins, however, are now licensed for use in 'severe renal failure', although they have yet~     to be trialed in dialysis patients.~      The investigators study, using continuous glucose monitoring as a new tool for monitoring of~     therapy should provide information on vildagliptin in add on therapy to insulin in this~     population.~   "
106249|NCT02176668|"~     The objective of this clinical trial is to explore pharmacodynamics and pharmacokinetics of~     YH4808 New Formulation in healthy volunteers.~   "
106250|NCT02176655|"~     This study proposes to compare the efficacy of sumatriptan and aspirin to placebo as an acute~     abortive treatment for delayed alcohol induced headache in adult subjects.~   "
106251|NCT02176642|"~     This is a randomized double-blind placebo-controlled clinical trial of posterior tibial nerve~     stimulation (PTNS) plus extended release oxybutynin versus PTNS alone (placebo pills) in~     women undergoing treatment of urgency urinary incontinence (UUI).~      The investigators hypothesize that combination therapy with PTNS and anticholinergic~     medication will result in a significant incremental improvement in UUI symptoms over that~     achieved with PTNS alone. In addition, the investigators hypothesize that the addition of~     anticholinergics to PTNS will result in a greater improvement in patients' perception of~     treatment response, symptom distress, and quality of life than PTNS alone.~      Specific Aim 1: To compare the change, from baseline, in mean number of UUI episodes per day~     using a 3-day bladder diary between PTNS plus anticholinergic medication versus PTNS plus~     placebo in women undergoing treatment for UUI.~      Specific Aim 2: To compare the change, from baseline, in a 24hr pad weight between PTNS plus~     anticholinergic medication versus PTNS plus placebo.~      Specific Aim 3: To compare subjective treatment response, symptoms distress, and quality of~     life between PTNS plus anticholinergic medication versus PTNS plus placebo utilizing the~     Patient Global Impression of Improvement (PGI-I) and the Overactive Bladder Questionnaire~     Short Form (OABq-SF).~      An interim analysis will be conducted by an independent entity after 50 participants have~     completed the study protocol. A Data Safety Monitoring Board is not utilized because the~     study utilizes FDA approved treatments for urgency urinary incontinence.~   "
106267|NCT02176421|"~     A prospective, open label, study evaluating JUVÉDERM® VOLBELLA with lidocaine treatment for~     the correction of skin depressions in the infra-orbital area (under the eyes)~   "
106307|NCT02175901|"~     No trial has examined the the efficacy of amoxicillin and metronidazole based quadruple~     therapy for Helicobacter pylori treatment. The study aims to compare the effectiveness and~     safety of 14-day amoxicillin-/metronidazole-based quadruple regiment and classical quadruple~     regiment for Helicobacter pylori eradication.~   "
106368|NCT02175108|"~     This study aims to fill a gap in the literature, identify relevant clinical measures, and~     provide insight into the independent modifiable risk factors of obesity in the CP population~     with the long-term goal of improving screening, management and prevention of obesity in this~     at-risk and underserved population.~   "
106252|NCT02176629|"~     Cognitive and memory problems characterize Alzheimer's disease (AD). Along with these~     disorders, psychological and behavioral symptoms (also known as neuropsychiatric symptoms) ,~     as well as pathophysiological processes are frequently found and involved significantly in~     maintaining autonomy, prognosis and treatment of the disease. Apathy or disorder motivation~     is the most common disorder behavior and early stages of cognitive impairment. Apathy is~     particularly associated with cognitive difficulties such as attention deficit disorder -~     concentration.~      In terms of prevention as term care , there is now a broad consensus that interventions on~     cognition and behavior must not be limited to pharmacological treatment but should also~     promote non-drug approaches.~      Interest in video games (serious games and serious games) as intervention support~     rehabilitation is growing. Similarly, the virtual reality (VR) and the new information~     technologies and communications offer significant opportunities in terms of rehabilitation~     and therapeutic assistance.~      This protocol is part of a European project to propose techniques for improving the treatment~     of people at risk of social exclusion ( VERVE project ) aims .~      A first experiment conducted in 2013 showed the acceptability of Virtual Reality (VR) in~     healthy elderly subjects. In a second step , it is important to validate the feasibility of~     using the RV or in frail subjects with mild cognitive impairment or Alzheimer's disease in~     mild to moderate in a clinical environment.~      This is a biomedical , randomized given to a group of patients with mild cognitive impairment~     or Alzheimer's disease & diseases associated with mild to moderate.~   "
106253|NCT02176616|"~     1. Purpose of the study~      1) To compare clinical outcome, procedure time, complication rate of patients who were~     changed to paroxysmal atrial fibrillation from persistent atrial fibrillation between~     ablation with conventional pulmonary vein isolation and ablation with conventional pulmonary~     vein isolation with conventional linear ablation.~      2. Scientific evidence of the study~        1. In atrial fibrillation patients, the maintenance of normal sinus rhythm showed~          significant reduction of mortality.~        2. drug therapy with anti-arrhythmic drug showed many complications and side effect, thus~          non-drug therapy such as catheter ablation is developed.~        3. catheter ablation has been performed for 10years world-wide, and showed superior~          treatment outcome compared with drug therapy.~        4. However, there are no consensus for proper ablation strategy in patients who were~          changed to paroxysmal atrial fibrillation from persistent atrial fibrillation .~        5. additional ablation make extent of myocardial injury and paradoxically increase~          recurrence rate, thus still controversial.~        6. Therefore, we will compare conventional pulmonary vein isolation with additional~          conventional linear ablation.~      3. Methods~        1. Treatment of All patients with atrial fibrillation is performed according to the~          standard treatment guideline of atrial fibrillation.~        2. there is no additional blood sampling, imaging study, or any other invasive procedure~          according to the inclusion of the study.~      4. study contents~      1) to evaluate superior ablation strategy in patients who were changed to paroxysmal atrial~     fibrillation from persistent atrial fibrillation~        -  compare conventional pulmonary vein isolation with additional liner ablation, both~          strategies are conventional ablation strategies being performed world-wide.~   "
106254|NCT02176603|"~     The purpose of this study is to determine whether adolescent and adult patients with~     phenylketonuria who are on long-term phenylalanine-restricted diet suffer from endothelial~     dysfunction.~   "
106255|NCT02176590|"~     This project will test the proximal and distal effects of an integrated dual-generation~     intervention, Power PATH, in Head Start preschoolers and their parents in Alabama.~   "
106256|NCT02176577|"~     The purpose of this study is to evaluate the Pharmacokinetics of Product 0405 in the~     Treatment of Atopic Dermatitis in Adolescent Subjects.~   "
106257|NCT02176564|"~     A pharmaco-epidemiological, observational study that aimed at assessing in a prospective~     manner the evolution of Quality of Life (QOL) in chronic obstructive pulmonary disease (COPD)~     patients treated with inhaled bronchodilators~   "
106258|NCT02176551|"~     The purpose of this study is to evaluate the safety and efficacy of product 0405 in pediatric~     subjects with Mild to Moderate Atopic Dermatitis.~   "
106259|NCT02176538|"~     The purpose of this study is to evaluate the safety and efficacy of product 0405 in pediatric~     subjects with Mild to Moderate Atopic Dermatitis.~   "
106260|NCT02176525|"~     The purpose of this study was to investigate antiviral activity, safety and pharmacokinetics~     of 5 days of monotherapy with BI 207127 in HCV genotype 1 (GT1) infected patients. Both~     treatment-naïve patients and patients previously treated with peginterferon and ribavirin~     were included. In addition, the effect of study medication was examined in a group of~     patients with liver cirrhosis.~   "
106261|NCT02176512|"~     Study to demonstrate the bioequivalence of telmisartan and HCTZ administered as fixed dose~     combination in comparison to the single unit formulations~   "
106262|NCT02176499|"~     Study to compare the natriuretic effect of telmisartan to placebo in mild-to-moderate~     hypertensive patients on a controlled sodium diet as well as to explore the effects of~     telmisartan on norepinephrine, plasma renin activity (PRA), plasma aldosterone, urine~     potassium, creatinin, chloride, bicarbonate and uric acid excretion. Additionally it was~     assessed whether the natriuretic effect disappears after treatment when telmisartan is~     stopped. The effects of telmisartan on seated clinic blood pressure and the relationship~     between urine sodium loss and decrease in ambulatory blood pressure after the first dose were~     assessed descriptively. Assessment of safety was also considered.~   "
106263|NCT02176486|"~     The purpose of this study is to characterize the safety and tolerability of ixazomib when~     administered as multiple oral doses at escalating dose levels in participants with lupus~     nephritis.~   "
106264|NCT02176473|"~     In an open-label feasibility study, fifteen will be recruited to participate in the study~     from among those who have already chosen of their own accord to undergo ECT (standard of~     care) at Yale Psychiatric Hospital for treatment of a depressive episode. These patients will~     receive computer-assisted cognitive behavior therapy (CCBT).~   "
106265|NCT02176460|"~     Uric acid may be involved in the activation of the innate immune response in osteoarthritis~     (OA) pathology and progression. This suggests that traditional gout therapy may be beneficial~     for OA. Our goal therefore is to assess colchicine, an existing commercially available agent~     for gout, for a new therapeutic indication-knee OA. The investigators propose a randomized~     clinical trial (RCT) of 16 weeks' therapy with standard daily dose oral colchicine or placebo~     for knee OA. The investigators hypothesize that colchicine will block inflammasome mediated~     inflammation, thereby improve the signs and symptoms of OA, and reduce synovial fluid, serum~     and urine inflammatory and biochemical joint degradation biomarkers. This trial will~     potentially provide data to support a new treatment option for knee OA.~   "
106266|NCT02176434|"~     This pilot study of combined kidney and hematopoietic stem cell transplantation attempts to~     establish a protocol to induce immunological tolerance as a new strategy to prevent renal~     graft rejection. If successful, this strategy would restore renal function, while avoiding~     the risks associated with long-term standard anti-rejection therapy, and would represent the~     first option to cure end-stage renal disease.~   "
122036|NCT01970137|"~     The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of~     KPS-0373 in SCD patients (Experience of clinical trials of KPS-0373)~   "
106268|NCT02176408|"~     Major depressive disorder (MDD) is the leading cause of disability in the developed world and~     is associated with lost productivity, increased health care utilization, and mortality.~     Several empirically supported treatments, such as antidepressant medication and cognitive~     behavioral therapy, exist for the treatment of MDD; however, studies have shown that as many~     as 34% of individuals do not respond to these treatments. Exercise and stretching~     interventions represent alternative strategies associated with strong effect sizes in past~     studies. Additionally, exercise has been shown to enhance cognitive functioning, especially~     attention and memory. This study aims to investigate the effect of a combined aerobic~     exercise and behavioral activation treatment (BA) for MDD. Behavioral activation treatment~     involves completing both pleasant and mastery-based activities with the goal of enhancing~     mood. The current study will recruit 32 MDD patients for an active treatment phase of nine~     60-90 minute sessions (6 weekly sessions and 3 biweekly sessions) of either BA plus exercise~     (BA+EX) or BA plus stretching (BA+STR). The purpose of this study is to identify if adding~     aerobic exercise to a brief psychosocial treatment can improve mood above and beyond an~     active control condition.~   "
106269|NCT02176395|"~     The purpose of this study is to explore the pharmacological mechanism of Danhong injection in~     the treatment of acute ischemic stroke.~   "
106270|NCT02176382|"~     The aim of the study is to assess the effect of an antiresorptive medication in combination~     with standard dose or alternate dose teriparatide.~   "
106271|NCT02176369|"~     Non Small Cell Lung Cancer (NSCLC) represents the first cancer related cause of death~     worldwide with 1.4 millions of deaths every years. Current standard therapies include~     platinum-containing drugs but at one year from diagnosis the survival rate is still low~     (30-40%) .~      The purpose of this study is to evaluate the role of a platinum-free drug, named Vinorelbine,~     administered by the so called metronomic schedule in order to prolong the progression free~     survival of patients.~   "
106272|NCT02176356|"~     A study to evaluate patient satisfaction, aesthetic and psychological impact of combined~     treatment with BOTOX® Cosmetic (onabotulinumtoxinA), JUVÉDERM® ULTRA XC, JUVÉDERM® ULTRA PLUS~     XC, JUVÉDERM® VOLUMA® XC, and LATISSE® (bimatoprost ophthalmic solution).~   "
106273|NCT02176343|"~     The purpose of this study is to characterize the safety and effectiveness of the ACRYSOF IQ~     ReSTOR +2.5 diopter (D) Multifocal Toric Intraocular Lens (IOL) in subjects at least 3 months~     and no more than 14 months after IOL implantation.~   "
106274|NCT02176330|"~     The purpose of this study is to assess the impact of using a virtual clinic which combines a~     web-based interactive questionnaire (ePAQ-PF) used in advance of clinic appointments in~     combination with a telephone consultation has on patient experience and cost compared to~     standard care.~   "
106275|NCT02176317|"~     This study is a prospective phase 1 single-center trial designed to determine the safety of a~     single intravenous infusion of autologous umbilical cord blood in children with Autism~     Spectrum Disorder (ASD) and assess the feasibility of various outcome measures to determine~     which measure(s) can be used as primary and secondary endpoints for a future randomized phase~     2 clinical trial. All subjects will receive infusion of cord blood cells at baseline with~     follow up assessments at 6 and 12 months.~   "
106276|NCT02176304|"~     Knee osteoarthritis is one of the most prevalent orthopedic conditions worldwide. With the~     aging population, a 40% patient increase is expected to present at clinics with complaints of~     primary osteoarthritis by 2025. Multiple studies have attempted to establish non-surgical~     criteria for knee arthritis and usage of resources to avoid major surgery. It has long been~     accepted as a treatment option for patients who have failed to respond to NSAIDs and other~     non-surgical therapies to receive intra-articular injections of steroid and anesthesia~     mixtures to hold off disease progression.~      Various studies have compared different sites of injection and the accuracy rate of the~     injection being within the joint. Recent studies report a 66% accuracy on palpation-guided~     injection on the anterolateral knee, 93% accuracy on palpation-guided injection on the~     superolateral portal of the knee, and new studies show an improvement of up to 98% with use~     of ultrasound guiding software. However, in a health care system with limited resources,~     providing patients with US-guided injections represented an increased cost of $178.35 per~     patient as per 2010 Medicare reports.~      Therefore, assuming these accuracy rates, we will compare the anterolateral and superolateral~     portals for knee injection and their clinical effect to monitor if in fact there is a~     difference in patient reported outcomes. As a secondary analysis, if no difference is found,~     a strong case for palpation-guided injections versus ultrasound-guided injections can be~     made.~      In this study we will prospectively enroll 60 patients to be divided into two 30 patient~     groups with primary knee osteoarthritis. Patients that qualify as subjects will be treated~     with an intraarticular knee injection through an anterolateral portal or a suprapatellar~     portal as per group in which they are placed. Scores will be given for pain of the injection~     and of the baseline illness and compared on a subsequent visit to assess self-reported~     functional outcomes.~   "
106277|NCT02176291|"~     The purposes of this project are to examine the feasibility, safety, tolerability and~     clinical effect of low-dose buprenorphine as a novel treatment for late-life~     treatment-resistant depression and to develop preliminary data about mechanism of action.~   "
106278|NCT02176278|"~     In this quality improvement program (DKD-TMT), patients will be recruited from multiple sites~     across Asia, with each site recruiting at least 300 type 2 diabetic patients with Diabetic~     Kidney Disease (DKD). After explanation by trained doctors and nurses, and with written~     informed consent, patients will be randomized to the UC (n=100, usual care) group, the EC~     (n=100, empowered care) group, or the TEC (n=100, team-based, empowered care) group. Patients~     in all 3 groups will undergo a comprehensive assessment (CA) guided by the templates in the~     Joint Asia Diabetes Evaluation (JADE) portal at baseline and at month 12. They will also~     self-administer a set of questionnaires for assessing quality of life and psychological~     distress during the CA at both time points.~      During the 12 months between the 2 CAs:~        -  Patients in the UC group will receive UC in accordance to the practice of the health~          institution.~        -  Patients in the EC group will receive a JADE summary report with personalized risk~          prediction, treatment targets and decision support with explanation from the doctor and~          nurse. In addition to receiving UC in accordance to the practice of the health~          institution, the nurse will telephone the patient 3-monthly to remind them to adhere to~          treatment, provide support and empower them to discuss with their doctors about their~          treatment needs and any concerns.~        -  Patients in the TEC group will be followed by a doctor-nurse team at least 3 monthly to~          achieve multiple targets, but tailored to patients' risk profile. The patients will~          receive telephone reminders and also be given a JADE follow up report 3-monthly.~      The primary composite endpoint is attainment of treatment goals and/or control of risk~     factors. The secondary composite endpoint is all-diabetes related clinical endpoints. The~     tertiary changes are behavioral changes, psychological well-being and quality of life.~   "
106300|NCT02175992|"~     Pancreatic cancer has a high mortality rate. Patients with an intended curative resection~     show a median survival of 17-23 months. Therefore, quality of life is very important in this~     patient group. In this study, the effect of pancreatic surgery on quality of life is~     measured.~   "
106301|NCT02175979|"~     The main objective is to investigate the effects of perioperative nutrition on postoperative~     ileus and anastomotic leakage in patients undergoing colorectal surgery.~      Perioperative enteral nutrition is compared to the standard of care (fasting~     perioperatively).~   "
106302|NCT02175966|"~     The purpose of the study is to determine whether the combination of Daclatasvir (DCV),~     Asunaprevir (ASV), BMS-791325 and Sofosbuvir is effective and safe in treating Hepatitis-C~     virus.~   "
106279|NCT02176265|"~     Objective of this First in Man study is to assess feasibility and safety of Qvanteq's~     bioactive coronary stent for treatment of stable coronary artery disease patients with de~     novo coronary artery stenosis in native vessels.~      The proprietary surface of Qvanteq's bioactive coronary stent improves the in-growth behavior~     of the stent in the treated vessel. In-vivo animal studies revealed fast in-growth (similar~     to BMS), which however is not resulting in excessive tissue overgrowth as observed in BMS but~     rather has an efficacy profile similar to drug-eluting stent (DES), meaning suppression of~     tissue overgrowth. This should reduce the risk of restenosis and thrombus formation despite~     the presence of a short term dual anti platelet therapy (DAPT). Furthermore, prolonged DAPT~     time as applied with current DES increases the bleeding risk of patients.~      The study is a prospective, multicenter, open-label, single arm study; conducted in up to 6~     cardiology centers in CH and NL. In total, approx. 35 patients will be enrolled. All patients~     will be treated with the Qvanteq's bioactive coronary stent. Clinical follow-up will occur at~     1, 6 & 12 months post-stent implantation. All patients will undergo angiography assessment~     (QCA) and Optical Coherence Tomography investigation (OCT) at baseline and at 6 months~     follow-up. Baseline OCT should be performed after the successfully completed angiographic~     procedure (documentary OCT). 1 and 12 months clinical follow-ups are conducted via telephone.~      Primary Angiographic endpoint is in-stent Late Lumen Loss at 6 months; assessed by off-line~     QCA. Primary OCT endpoint is mean neointimal thickness at 6 months; assessed by off-line OCT~     analysis.~   "
106280|NCT02176252|"~     The study is designed to evaluate the safety, tolerability, pharmacodynamics and~     pharmacokinetics of AZD1722 in healthy Japanese subjects at increasing doses given for 7 days~     in order to allow for including Japanese subjects in future global studies. A cohort of~     Caucasian subjects will be included in the study to evaluate cardiac effects, assessed by~     digital ECGs (dECG) recordings, also in Caucasian subjects.~   "
106281|NCT02176239|"~     The purpose of this study is to demonstrate the utility of measuring outcomes in 5% treatment~     naïve Intravenous Immunoglobulin (IVIg) Primary Immunodeficiency Disease (PIDD) patients~     using infusion nurse and patient measured physical, quality of life (QOL), respiratory, and~     disability assessments using CareExchange in the home setting.~   "
106282|NCT02176226|"~     This study will evaluate a Smartphone intervention for depression and anxiety that uses~     machine learning to tailor treatment for patients. The intervention, referred to as~     IntelliCare, delivers patient-specific treatment material and motivational messaging via a~     mobile phone, to help individuals with depression and/or anxiety. Information and data~     received from the patient will inform the tailored treatment approach through machine~     learning. The purpose of this study is to obtain preliminary information on the feasibility~     and effectiveness of IntelliCare in improving symptoms of depression and anxiety.~   "
106283|NCT02176213|"~     This study is being done to learn more about the drug, pomalidomide and to gather data on its~     safety and side effects when used in combination with commercially available cyclophosphamide~     and dexamethasone. This combination is considered experimental and has not been approved by~     the FDA.~      Pomalidomide is a third generation immunomodulatory (IMiDs) agent, which is a more potent~     version of thalidomide and lenalidomide drugs that have been approved by the United States~     Food and Drug Administration [FDA] for the treatment of MM. In February 2013, pomalidomide~     was also approved by the FDA for patients with MM who have had more than 2 types of therapy.~      Pomalidomide is taken orally as capsules, and cyclophosphamide and dexamethasone are also~     taken orally as tablets in this study. Cyclophosphamide and dexamethasone are commercially~     available and are often used in combination with other drugs to treat Multiple Myeloma.~     Preliminary data from both the laboratory and patient studies suggest that this combination~     of drugs is more effective than pomalidomide and dexamethasone alone. However, the regimen~     being used in this study, which consists of daily cyclophosphamide, also permits support of~     low blood counts with either injections or transfusions as needed.~   "
106284|NCT02176200|"~     Study to compare the lung and oropharyngeal deposition of Berodual® (fenoterol hydrobromide~     50μg + ipratropium bromide 20μg /1x puff) delivered via the Respimat® inhaler and the same~     dose of Berodual® delivered via an hydrofluoroalkane (HFA) - metered dose inhaler (2 x puffs~     ) in COPD patients at different inspiratory flow rates.~   "
106285|NCT02176187|"~     Study to compare the effect of 'natural' as opposed to 'optimal' technique on the percentage~     of the dose received from the Respimat® inhaler and metered dose inhaler~   "
106286|NCT02176174|"~     Specific cardiovascular diseases, such as stroke and heart attack, have been shown to vary by~     ethnic group. However, less is known about differences between ethnic groups and a wider~     range of cardiovascular diseases. This study will examine differences between ethnic groups~     (White, Black, South Asian and Mixed/Other) and first lifetime presentation of twelve~     different cardiovascular diseases. This information may help to predict the onset of~     cardiovascular diseases and inform disease prevention strategies.~      The hypothesis is that different ethnic groups have differing associations with the range of~     cardiovascular diseases studied.~   "
106287|NCT02176161|"~     This is a Phase II clinical study to determine if Metformin can increase Prostate Specific~     Antigen (PSA) doubling time for patients with Prostate Cancer who have failed primary~     treatment with radiation, or surgical patients that are at high risk for recurrence based on~     surgical pathology. Men with confirmed prostate cancer and rising serum PSA levels will~     receive Metformin and will be monitored for PSA response and disease progression.~   "
106288|NCT02176148|"~     Cutaneous lupus is a chronic, relapsing, auto-immune skin disease that can have many~     presentations. Its effect on physical appearance greatly affects patients' quality of life.~     In addition, 10% of patients with cutaneous lupus will develop systemic lupus. Topical~     therapies are the mainstay of cutaneous lupus treatment; however patients often find these~     treatments to be messy, inconvenient, or ineffective. In addition, for more severe disease~     patients are often placed on concurrent systemic therapies. The primary hypothesis of our~     study is that poor adherence contributes to poor treatment outcomes in patients with~     cutaneous lupus.~   "
106289|NCT02176135|"~     The main purpose of the study is to evaluate the safety of oral auranofin, a gold compound,~     in patients with HIV infection whose viral load has been suppressed by antiretroviral therapy~     for no less than 3 years and have a CD4+ cell count over 500 cells/uL~   "
122037|NCT01970124|"~     The purpose of this study is to evaluate the long-term safety, efficacy, and pharmacokinetics~     of KPS-0373 in SCD patients~   "
106290|NCT02176122|"~     No randomized controlled trials (RCTs) have yet been performed comparing different treatment~     options for AmpC or ESBL-producing Enterobacteriaceae. During the last 10 years we have seen~     an exponentially increasing rate of carbapenem resistance worldwide, including Australia and~     New Zealand. The investigators urgently need data from well-designed RCTs to guide clinicians~     in the treatment of antibiotic resistant Gram-negative infections. The investigators face a~     situation where a commonly used antibiotic for these infections (meropenem) may be driving~     carbapenem resistance. For this reason, the investigators are seeking to compare a~     carbapenem-sparing regimen with a carbapenem for the treatment of these infections. Formal~     evaluation of safety and efficacy of generic antibiotics in the treatment of infection is of~     immense clinical and public health importance, and no formal trial has yet been conducted to~     address these issues. The international collaboration between teams of clinician researchers,~     some of whom are leaders in their field, makes it highly likely that the outcomes of this~     trial will have a significant impact on clinical practice.~      The investigators' hypothesis is that piperacillin/tazobactam (a carbapenem-sparing regimen)~     is non-inferior to meropenem (a widely used carbapenem) for the definitive treatment of~     bloodstream infections due to third-generation cephalosporin non-susceptible E. coli or~     Klebsiella species.~   "
106291|NCT02176109|"~     In this study, the investigators study the prognostic role of oxidative stress metabolism and~     iron in Acute myeloid leukemia.~   "
106292|NCT02176096|"~     The objective of this demonstration project is to compare a novel long-acting starch,~     Glycosade, a hydrothermally processed high amylopectin maize starch, versus gastrostomy~     tube-dextrose infusion in maintaining euglycaemia overnight in children with GSD-I. Glycosade~     has been reported to increase the duration of euglycaemia. Its slow release and longer~     periods of normal blood sugar achieved would preclude the need for the overnight dextrose~     infusion and eliminate the need for the surgical insertion of a gastrostomy tube for this~     purpose. Glycosade also reportedly causes fewer gastrointestinal side effects, thus~     potentially improving compliance to therapy. The investigators intend to evaluate Glycosade~     in our patients and determine its efficacy on glucose control, on the length of normoglycemia~     achieved and to determine if there are reduced side effects in our patients with GSD-I. This~     will be accomplished by an open label study of Glycosade in GSD-I patients who consent to the~     protocol.~   "
106293|NCT02176083|"~     Most young breast cancer patients undergo chemotherapy and/or endocrine therapy, treatments~     that impair ovarian function and result in significant reproductive health late effects.~     These late effects include symptoms of estrogen deprivation (e.g., hot flashes and vaginal~     dryness), which are distressing in young breast cancer survivors (YBCS). The goal of this~     pilot study is to test the feasibility of a 4-week text message based intervention on hot~     flashes and vaginal dryness in YBCS. YBCS will be randomized in a 1:1 ratio to the~     intervention (text messages on hot flash and vaginal dryness management) and control arms.~     All participants will be prompted to provide daily hot flash frequency and severity via text~     messaging. The primary hypothesis is YBCS will have high rates of daily hot flash reporting~     via text messaging. Secondarily, we will compare changes in hot flash frequency, hot flash~     severity and vagina dryness between the intervention and control arms.~   "
106294|NCT02176070|"~     The purpose of this study is to learn about reproductive health, including fertility and~     pregnancies, in people with vasculitis.~   "
106295|NCT02176057|"~     The main purpose of this study is to determine if ocular Chlamydia trachomatis infection can~     be eliminated in communities in Nepal following mass antibiotic distributions with~     azithromycin. The investigators will study both clinical trachoma and ocular C. trachomatis~     infection. The overall objective is to determine if the current World Health Organization~     (WHO) treatment strategy results in elimination of trachoma and infection.~        1. The investigators hypothesize that 24 communities in Kanchanpur, Kailali, and Achham~          districts of Nepal which receive mass antibiotic treatments will achieve elimination of~          trachoma as a public health problem (clinical disease <5% in children 1-9 years old)~          more frequently than communities which have not received antibiotic treatments.~        2. The investigators hypothesize that infection with C. trachomatis will be undetectable in~          all members within a community following mass treatment as determined by the most highly~          sensiti1. The investigators hypothesize that 24 communities in Kanchanpur, Kailali, and~          Achham districts of Nepal which receive mass antibiotic treatments will achieve~          elimination of trachoma as a public health problem (clinical disease <5% in children 1-9~          years old) more frequently than communities which have not received antibiotic~          treatments.~      2. The investigators hypothesize that infection with C. trachomatis will be undetectable in~     all members within a community following mass treatment as determined by the most highly~     sensitive nucleic acid amplification testing available (mRNA-based APTIMA and DNA-based~     AMPLICOR PCR).ve nucleic acid amplification testing available (mRNA-based APTIMA and~     DNA-based AMPLICOR PCR).~   "
106296|NCT02176044|"~     Spatial working memory (ability to remember where objects are in space) is impaired in~     patients with schizophrenia. It is thought that this impairment occurs due to problems with~     the chemical messenger (neurotransmitter), glutamate, and the N-methyl-D-aspartate (NMDA)~     glutamate receptor, particularly in the hippocampal brain region. NMDA receptor activation~     leads to increases in the release of the second messenger Nitric Oxide. Impaired NMDA~     receptor function would therefore be predicted to lead to reductions in Nitric Oxide~     production. Recent work suggests that a drug, sodium nitroprusside, which releases nitric~     oxide, enhances some aspects of cognition in schizophrenia (specifically related to negative~     symptoms). In this study, the investigators will test the hypothesis that sodium~     nitroprusside improves spatial working memory in patients with schizophrenia. 15 patients~     will receive sodium nitroprusside, and 15 will receive a nonactive compound (placebo). Their~     performance on a spatial working memory task will be tested before and after administration~     of sodium nitroprusside or placebo.~   "
106297|NCT02176031|"~     This research study is a Phase II clinical trial, which tests the safety and effectiveness of~     an investigational drug Natalizumab in treating Acute Graft versus Host Disease in the~     Gastrointestinal Tract.~   "
106298|NCT02176018|"~     The purpose of this study is to evaluate the efficacy and effectiveness of daily~     dextromethorphan/quinidine (Nuedexta) in reducing the frequency and progression of episodic~     migraine.~   "
106299|NCT02176005|"~     The purpose of this study is to determine whether DAV132 is safe and effective for capturing~     fecal residues of moxifloxacin in healthy volunteers.~   "
106308|NCT02175888|"~     Iron deficiency (ID) with or without anaemia (IDA) is a major public health problem~     worldwide, especially in women of reproductive age and young children. Iron supplementation~     is an effective strategy to prevent and treat ID and IDA. There is a lack of data on iron~     bioavailability from different supplementation regimens and how to optimize bioavailability~     in a cost-effective and patient-friendly way. The present study will test whether the~     fractional and total iron absorption from iron supplements (60 mg) administered daily for 14~     days differs from that of iron supplements (60 mg) administered every second day for 28 days.~     The prevailing serum hepcidin concentration (SHep) is the major determinant of iron~     absorption and erythrocyte iron utilization. Therefore we will monitor SHep during the whole~     supplementation period. We hypothesize that the fractional and total iron absorption from the~     daily administration of 60 mg is lower than that from the administration on every second day~     due to increased SHep levels when supplements are administered daily.~      The study will provide important insights about the optimization of iron bioavailability from~     different supplementation regimens including the performance of SHep, a key regulator of~     human iron metabolism.~   "
106309|NCT02175875|"~     The study will investigate the effect of the oral antiplatelet agent ticagrelor (Brilique)~     when it is administrated through a nasogastric tube in comatose patients. The platelet~     function can be determined by various platelet function tests (PFT), Multiplate and VerifyNow~     . As control, the reference intervals from the literature are used. Futhermore, plasma~     concentrations of the active metabolite will be determined at aeveral timepoints after first~     intake of a bolus dose.~   "
106310|NCT02175862|"~     In May 2010 the first danish physician-staffed Helicopter Emergency Medical Service (PS-HEMS)~     was implemented in Region Zealand and the Capital Region (excluding Bornholm) of Denmark.~      In relation to the introduction of PS-HEMS, a team of collaborators lead by Rasmus~     Hesselfeldt, conducted an observational study to investigate the possible effects on time to~     definitive care, secondary transfers and 30-day mortality in a before and after design.~      Results showed reduced time from first dispatch to arrival at the trauma centre from 218 min~     to 90 min. Secondary transfers to the trauma centre dropped from 50 % to 34 % and 30-day~     mortality significantly reduced from 29 % to 14 % in the year after implementation.~      The present study is an observational cohort study with long-term follow-up of the same~     trauma population as mentioned above. Patients were followed until may 1st, 2014.~      Primary outcome is early retirement and secondary outcomes are quality of life and mortality.~      The investigators hypothesize that a greater proportion of trauma patients in the after~     period will remain in occupation after approx. 3 to 4.5 years compared with trauma patients~     treated in the before period.~   "
106311|NCT02175849|"~     Tuberculosis burden in Vietnam increasing with contribution from low detection rates and~     increased drug resistance. There is a need to identify MDR-TB (MultiDrug Resistant~     Tuberculosis) among both notified TB cases and their contacts in the community. Traditional~     contact tracing often focuses on household contacts while strains of TB circulate in homes,~     schools, workplaces, and beyond. Social network Analysis (SNA) is a comprehensive approach~     which includes a set of persons and the connections among them used for analysis of structure~     of disease transmission.~      In this study, SNA will be used to collect network data from 60 newly detected Rifampicin~     resistant TB patients including an expected 50 MDR-TB patients living in Hanoi, and to~     identify and test potential MDR-TB cases.~   "
106312|NCT02175836|"~     Patients with Ischaemic and Dilated Cardiomyopathy, face an increased risk for Arrhythmic~     Sudden Cardiac Death. The purpose of this study is to estimate the performance of Modern~     Non-Invasive Indices and the performance of Programmed Ventricular Stimulation in Sudden~     Cardiac Death Prediction.~   "
106313|NCT02175823|"~     To improve quality of life of elderly cancer survivors~        1. Using physical activity and environmental sensing technology~        2. Monitoring physiological indicators of cancer recurrence~             -  Analyzing the patient's circadian rhythm, frailty and his/her vital sign.~             -  Vital sign includes blood pressure, weight and hrv.~        3. Collecting the patient information in real time~             -  Giving alarm information to the patient, if any special cases our system found.~             -  Giving circadian rhythm report to the patient.~             -  Giving healthy report to the patient, collected from his/her vital sign.~   "
106314|NCT02175810|"~     Obesity is a growing problem worldwide and its prevention has become one of the leading~     priorities for the World Health Organisation. Obesity results from chronic imbalance between~     energy intake and energy expenditure. Although early prevention of obesity is preferable,~     surgical treatment is often required for severely obese people.~      Bariatric surgery has been shown to be the most effective therapy for severe obesity. Weight~     loss following bariatric surgery results in significant improvements in coexisting~     comorbidities, such as diabetes and hypertension but there is controversy whether bariatric~     surgery also improves aerobic capacity.~      The purpose of this study is to investigate the effects of bariatric surgery on~     cardiopulmonary function and on daily physical activity. It is hypothesized that bariatric~     surgery will improve aerobic capacity and result in beneficial lifestyle changes from~     sedentary to more active.~   "
106315|NCT02175797|"~     The purpose of this study is to report the stability of atrial and ventricular leads by~     absence of effect of the MRI exam on the pacing and sensing threshold and to report the~     safety based on the serious adverse events.~   "
106316|NCT02175784|"~     The purpose of this study is to assess the efficacy (superiority to placebo) of ipragliflozin~     based on the changes in HbA1C, as well as its safety, in patients with type 2 diabetes~     mellitus in combination with an insulin preparation once daily for 16 weeks. The long-term~     (52 weeks) safety and the persistence of the efficacy will also be evaluated.~   "
106317|NCT02175771|"~     The primary objective of the study is to evaluate the long-term safety of fluticasone~     propionate (Fp) inhalation powder in 2 strengths and fluticasone propionate/salmeterol~     inhalation (FS) powder in 2 strengths when administered with the Teva multidose dry powder~     inhaler (MDPI) device over 26 weeks in patients with persistent asthma.~   "
106348|NCT02175368|"~     Investigation on the clinical performance of a new dental adhesive when used in direct~     filling therapy after phosphoric acid etching.~      Hypothesis: The new adhesive shows an acceptable clinical performance and allows a good~     filling quality.~   "
122038|NCT01970111|"~     The purpose of this study is to evaluate the long-term safety, efficacy, and pharmacokinetics~     of KPS-0373 in SCD patients.~   "
106318|NCT02175758|"~     This study will have two parts as follows:~      The PK Lead-in Phase of the study will evaluate the steady state pharmacokinetics (PK) and~     confirm the dose of sofosbuvir (SOF) in hepatitis C virus (HCV)-infected pediatric~     participants. The PK Lead-in Phase will also evaluate the safety and tolerability of 7 days~     of dosing of SOF+ribavirin (RBV) in HCV-infected pediatric participants.~      The Treatment Phase will be initiated by age cohort after confirmation of age-appropriate SOF~     dosage levels. Participants from the PK Lead-in Phase will immediately rollover into the~     Treatment Phase with no interruption of study drug administration. The Treatment Phase will~     evaluate the antiviral efficacy, safety, and tolerability of SOF+RBV for 12 or 24 weeks in~     pediatric participants with genotype 2 or 3 HCV infection, respectively.~   "
106319|NCT02175745|"~     To evaluate 18F-FDOPA PET obtained from PET/CT or PET/MRI imaging in patients with newly~     diagnosed or recurrent gliomas.~   "
106320|NCT02175732|"~     Diabetes Distress (DD) refers to the emotional and behavioral challenges and burdens that~     arise through living with and managing diabetes. High DD is characterized by feeling~     frustrated, overwhelmed and discouraged by the demands of diabetes, and high DD may have a~     negative impact on disease management and glycemic control; poor glycemic control can also~     have a negative effect on DD.~      Few interventions have been assessed that directly target DD or mood in adults with Type 1~     diabetes. In this study the investigators will compare two active, evidence-based behavioral~     interventions to reduce high DD and improve glycemic control and disease management:~        1. A Type 1 diabetes education protocol ('KnowIt') that brings together new advances in~          diabetes education and behavioral management.~        2. A DD-reduction protocol ('OnTrack') that helps identify and address the personal~          stresses and strains of having diabetes.~      Participants in both arms will attend a single, day-long workshop, four hour-long web group~     meetings and four personal phone calls with the group facilitator during the intervention~     period. Assessments will be carried out at baseline and at three and nine months.~      Hypothesis 1: OnTrack will be superior to KnowIt in the primary and secondary outcomes at~     follow-up.~      Hypothesis 2: Changes in self-efficacy and fear of hypoglycemia over time will mediate the~     difference between the two study arms and primary outcome.~      Hypothesis 3: The differences between the two study arms and changes in the primary outcomes~     will be qualified by patient characteristics such as age, length of diagnosis, higher~     baseline distress or HbA1c.~   "
106321|NCT02175719|"~     Investigation of the clinical condition in patients with cervical dystonia by Toronto Western~     Spasmodic Torticollis Scale (TWSTRS)~   "
106322|NCT02175706|"~     Rationale:~      The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has~     led to a significant reduction in morbidity but there are further demands on DES performance.~     Such demands are an optimized performance in very challenging coronary lesions; third~     generation DES were developed in an effort to further improve DES performance in such~     challenging lesions. Two CE-certified third generation DES (Resolute Integrity and Promus~     Element stents) are currently available; there are no data that indicate an advantage of one~     of these DES over the other.~      Objective:~      To investigate whether the clinical outcome is similar after implantation of the Promus~     Element versus the Resolute Integrity stent (non-inferiority hypothesis).~      Study design:~      Multicenter, prospective, randomized single-blinded study.~      Study population:~      Patients who require percutaneous coronary interventions (PCI) for the treatment of coronary~     stenoses with an indication for DES use, according to current guidelines and/or the operators~     clinical judgement. All clinical syndromes will be included.~      Intervention:~      In patients who are eligible for DES implantation, the type of DES implanted will be~     randomized (Resolute Integrity stent versus Promus Element stent). At the start of the study,~     both DES will also be used in routine clinical practice.~      Main study endpoints:~      The primary endpoint is the incidence of target vessel failure at one year follow-up. Target~     vessel failure (TVF) is a composite endpoint consisting of cardiac death, target vessel MI,~     or clinically driven target vessel revascularization. Further secondary clinical and~     angiographic endpoints will be investigated, defined in accordance with suggestions of the~     Academic Research Consortium (ARC). Of note, the angiographic assessment is based on~     clinically indicated projections only and results in no additional x-ray exposure. There is~     no routine angiographic follow-up. If angiographic data are available in patients who undergo~     symptom-driven re-catheterization, we will analyze these data to get insight into the~     mechanisms of potential DES restenosis.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: Patients will receive the routine clinical treatment. As a consequence, the~     risks of this trial do not exceed the risks of any routine PCI procedure.~   "
106323|NCT02175693|"~     Investigation of the clinical condition and safety in patients with cervical dystonia~   "
106324|NCT02175680|"~     This study is a Phase 2b study designed to evaluate the efficacy, safety, and tolerability of~     PRO 140 monotherapy for the maintenance of viral suppression in subjects who are stable on~     combination antiretroviral therapy.~      Consenting subjects will be shifted from their combination antiretroviral regimen to PRO 140~     monotherapy for 12 weeks. Total treatment duration with PRO 140 will be 14 weeks with the one~     week overlap of existing retroviral regimen and PRO 140 at the beginning of the study~     treatment, and one week overlap at the end of the treatment in subjects who do not experience~     virologic failure.~   "
106325|NCT02175667|"~     Determine the influence of a treatment with Global Postural Reeducation techniques and the~     personality traits in the stabilometric parameters~   "
106326|NCT02175654|"~     The purpose of this study is to assess the efficacy of single-agent regorafenib in the~     second-line treatment in metastatic colorectal cancer with any RAS or BRAF mutation~     previously treated with FOLFOXIRI plus bevacizumab in terms of progression-free survival at 6~     months.~   "
106327|NCT02175641|"~     This goal of this randomized controlled effectiveness trial is to compare the effectiveness~     of a peer-led health lifestyle intervention (Peer GLB) versus usual care services in~     supportive housing agencies in New York City and Philadelphia serving diverse clients with~     serious mental illness who are overweight or obese. The intervention follows the Group~     Lifestyle Balance curriculum derived from the Diabetes Prevention Program and that has been~     shown to help people achieve clinically significant weight loss (equal to or greater than 5%~     weight loss of initial weight). The intervention will be delivered by trained~     peer-specialists employed at the supportive housing agencies and supervised by the study~     team. Peer GLB is a 12-month group intervention that focuses helping people lose weight by~     improving people's diet and increasing their physical activity and consists of weekly core~     group sessions (3 mo.), bi-monthly transitional group sessions (3 mo.), and maintenance~     monthly sessions (6 mo.).~      We plan to enroll 300 clients with serious mental illness who are overweight/obese (BMI equal~     to or greater than 25) from our two supportive housing agencies. Clients will be randomized~     to either the Peer-led healthy lifestyle intervention or usual care conditions. The primary~     outcome for this study is achieving clinically significant weight loss (equal to or greater~     than 5% weight loss from baseline weight) at 12 and 18 months post randomization. The~     secondary outcomes for this study include overall reductions in weight, waist circumference,~     blood pressure, and improvements in physical activity, self-efficacy, recovery and~     health-related quality of life. Repeated assessments will be at baseline, 6, 12 and 18 month~     post randomization.~      Primary Hypothesis: Peer GLB participants will have a higher proportion of persons achieving~     clinically significant weight loss (equal to or greater than 5% weight loss) at 12 and 18~     months than UC participants.~      Secondary Hypothesis: At 6, 12, and 18 months post-randomization, there will be significant~     reductions in average weight, waist circumference, blood pressure, and significant~     improvements in physical activity, self-efficacy, recovery, and health-related quality of~     life in Peer GLB compared to UC.~   "
106369|NCT02175095|"~     Regorafenib is approved in the treatment for metastatic colorectal cancer patients who have~     been progressed after standard therapies, however, there has not been a predictive biomarker.~     The investigators designed this study to investigate whether [18F]FLT-PET might paly a role~     as a predictive imaging biomarker of treatment responses to regorafenib.~   "
106328|NCT02175628|"~     Purpose: This study will evaluate a new ultrasound imaging technology called acoustic~     angiography. Acoustic angiography uses an ultrasound contrast agent, already FDA approved for~     use in cardiology, to enhance imaging of blood vessels. Since acoustic angiography uses~     ultrasound, and not x-rays, the patient is not exposed to ionizing radiation, unlike~     traditional angiography and mammography. Specific goals will be to evaluate the quality of~     the images provided by acoustic angiography in the human breast, and furthermore to evaluate~     whether or not acoustic angiography provides additional diagnostic information over~     traditional ultrasound which could provide an improvement in assessing breast lesions.~     Specifically, this additional diagnostic information will hopefully enable us to reduce false~     positive tests and discriminate lethal cancers from non-lethal disease.~      Participants: The investigators are recruiting 60 patients from the UNC Breast Clinic who are~     undergoing core needle biopsy or surgical biopsy (BIRADS 4 and 5 breast lesions).~      Procedures (methods): Acoustic Angiography imaging will be performed in conjunction with~     standard diagnostic imaging, including b-mode ultrasound . Then, a reader study will be~     conducted to compare these modalities. Finally, the images will be analyzed with image~     processing techniques to determine quantitative metrics exhibited by the blood vessel~     morphology in the images. These metrics will be utilized to develop a malignancy score~     equation to predict malignancy of a lesion.~   "
106329|NCT02175615|"~     The specific objectives of this study are:~      Primary:~      1)To determine the relationship between cyclosporine AUC achieved prior to engraftment and~     severe aGVHD (grade III and IV)~      Secondary:~        1. To determine the relationship between individual concentration-time points achieved~          prior to engraftment and severe aGVHD (grade III and IV)~        2. To validate the previously developed LSS to determine cyclosporine AUC after IV~          administration at steady state and~        3. To describe the relationship between cyclosporine AUC and individual concentration-time~          points achieved prior to engraftment and other HSCT outcomes (clinically significant~          aGVHD (grade II to IV), hypertension, engraftment failure, relapse~   "
106330|NCT02175602|"~     The purpose of this study is to assess the effect of Daclatasvir, Asunaprevir, and BMS-791325~     on the pharmacokinetics of selective serotonin reuptake inhibitors.~   "
106331|NCT02175589|"~     The purpose of this study is to evaluate the effect of discontinuation of colchicine~     treatment in a specific group of asymptomatic FMF patients with a single mutation in MEFV~     gene, both from a clinical and laboratory aspects.~   "
106332|NCT02175576|"~     Randomized Controlled Study to determine if preservation of ligaments provides increased~     functional ability post-operatively in comparison to traditional TKA which sacrifices soft~     tissue.~   "
106333|NCT02175563|"~     According to the European Resuscitation Council (ERC) Guidelines for patient to a depth of~     approximately 5-6 cm on a firm and flat surface when possible. However, Cardiopulmonary~     resuscitation (CPR) performers may need to continue the chest Resuscitation 2010, CPR~     performers should compress the sternum of a compression in an oblique direction, such as in~     elevators. For a pregnant patient in cardiac arrest, the 2010 ERC Guidelines recommend that~     the performer place the patient in a left-lateral tilt of 15 - 30° using a firm wedge to~     support the pelvis and thorax because the pregnant uterus can compress the inferior vena~     cava. We hypothesized Smartphone based chest compression feedback app would improves quality~     of CPR in an angulated surface.~   "
106334|NCT02175550|"~     A new Nobel Biocare implant, NobelReplace Conical Connection (NR CC) has been developed. The~     implant is a two piece design to allow both one- and two- stage surgical procedures. The~     entire implant surface has a porous titanium oxide of approximately 10µm thick (TiUnite) to~     promote and maintain primary stability, which later on leads to secondary stability.~      NR CC implants are used as the foundation for anchoring tooth replacements in either jaw.~     Restorations range from replacing one single tooth to an entire arch of bridgework. The~     implants are also intended as retentive elements for overdenture applications.~      The present study is designed to evaluate, after the insertion of the NR CC, the marginal~     bone levels and bone remodelling at the implant sites over various time points up to 5 years.~     Parameters as soft tissue index, pink aesthetic score (PES) and bleeding on probing (BoP) are~     as well evaluated together with implant success and survival rate.~      Using the OHIP-14 questionnaire patients satisfaction is assessed. The results of this~     clinical investigation will demonstrate clinical safety and reliability of the NR CC using~     different treatment options.~   "
106335|NCT02175537|"~     The purpose of the study is to pilot-phase test the effectiveness of the microclinic social~     induction model and its effects on behavioral and metabolic outcomes in different levels of~     social and familial relationships in Qatar. The investigators novel microclinic model is~     based on the principle that both healthy and unhealthy behaviors spread through preexisting~     social networks. A microclinic is a small group of approximately 2-8 friends or family~     members who are taught to modify their own behaviors as well as the behaviors of those around~     them, with a particular focus on the four M's: Meals, Movement, Monitoring, and Medication.~     More than social support groups or peer-to-peer interventions, the microclinic model is~     unique in its focus on the long-term propagation of healthy behaviors throughout a~     participant's entire social network. Qatar is uniquely positioned (with its central~     geographic location in the Gulf region and its leadership in science and education) to~     spearhead a regional intervention focused on managing and preventing diabetes in the Gulf~     region.~   "
106349|NCT02175355|"~     Primary: To identify doses of Micardis®(telmisartan) which, administered once daily, are more~     effective than placebo and not inferior to HCTZ in lowering systolic blood pressure (SBP) in~     patients with isolated systolic hypertension (ISH), and to assess the dose response~     relationship of the antihypertensive effect of telmisartan over the dose range of 20 to 80~     mg.~      Secondary: Target fall in SBP, change from baseline in seated DBP. Safety and tolerability of~     Micardis® and HCTZ in patients with ISH as measured by changes in physical examinations,~     heart rate, laboratory parameters and/or 12-lead ECG, as well as the incidence and severity~     of adverse events.~   "
106350|NCT02175342|"~     This pharmacodynamic and pharmacokinetic dose-ranging study aims to determine the optimal~     dose of tiotropium inhaled as a solution from a Respimat device once a day for three weeks in~     patients with COPD.~   "
106351|NCT02175329|"~     60 bridge frameworks are CAD/CAM manufactured from zirconia-ceramic; 30 bridges are veneered~     with CAD/CAM fabricated lithium disilicate ceramic, 30 bridges are manually layered. The goal~     is to compare clinical survival , biological or technical behaviour of the restorations.~   "
106336|NCT02175524|"~     The purpose of this study is going to determine the odds ratio of metabolic syndrome (MS),~     the habit of areca nut chewing, antioxidant, and inflammatory status in oral and esophageal~     patients. The current study was designed as a case-control study. Patients proved to be oral~     and esophageal cancer and had the habit of areca nut chewing are defined as case group.~     Patients proved to be oral and esophageal cancer and did not have the habit of areca nut~     chewing are defined as control group. The participants' age, blood pressures, and smoking~     habits will be recorded. Body weight, height, waist, and hip circumferences will be measured.~     Fasting venous blood samples will be obtained to determine hematological parameters [i.e.,~     serum creatinine, total cholesterol, triacylglycerol, low density lipoprotein-cholesterol,~     high density lipoprotein-cholesterol, malondialdehyde, superoxide dismutase, glutathione~     peroxidase, catalase, and inflammatory markers (C-reactive protein, tumor necrosis~     factor-alpha, and interleukin-6)]. Logistic regression analyses are going to perform to~     examine the relationship between areca nut chewing and MS in this population. If we can make~     sure the relationship between areca nut chewing and MS, the clinicians and nutritionists can~     teach people to quit areca nut chewing in order to avoid the possibility of developing~     metabolic syndrome and cardiovascular disease.~   "
106337|NCT02175511|"~     Importance: Less than fifty percent of patients with hypertensive disease manage to maintain~     their blood pressure (BP) within normal levels. Practical (Pragmatic) and sustainable models~     are needed in order to improve BP management in patients with hypertension.~      Objective: To evaluate whether cloud BP system integrated with computerized physician order~     entry (CPOE) is useful for improving BP management as compared with traditional care.~   "
106338|NCT02175498|"~     The purpose of this study is to assess the effectiveness of Homoeopathic treatment in female~     infertility.~   "
106339|NCT02175485|"~     Primary Objective:~      To collect and analyze clinical data of Allergic Rhinitis patients' Total Nasal Symptom Score~     (TNSS) change after Dellegra internal use under high density pure Japanese cedar pollen~     exposure.~      Secondary Objective:~      To collect and analyze clinical data of Allergic Rhinitis patients' change in Total Symptom~     Score (TSS) and amount of nasal discharge, safety, and overall patients' impression about~     efficacy of Dellegra after Dellegra internal use under high density pure Japanese cedar~     pollen exposure.~   "
106340|NCT02175472|"~     Light treatment was originally employed in Parkinson's disease (PD) to determine if it might~     be effective in treating co-existing symptoms of depression and insomnia. However, a~     preliminary double-blind study as well as other studies reported significant improvement in~     both motor and co-existing Parkinsonian symptoms. As of yet, no long term double blind study~     has validated these findings. This study will use a double-blind design to evaluate the~     safety and efficacy of a non-invasive light therapy device to be used with ongoing~     pharmacotherapy for PD, over a six month treatment period.~   "
106341|NCT02175459|"~     Regeneration of mature cells that produce functional insulin represents a major focus of~     current diabetes research aimed at restoring beta cell mass in patients with most forms of~     diabetes. The capacity to adapt in response to diverse physiological conditions during life~     and the consequent ability to cope for increased metabolic demands is a distinctive feature~     of the endocrine pancreas in the regulation of glucose homeostasis. Both beta and alpha cells~     are dynamically regulated to continually maintain a balance between proliferation,~     neogenesis, and apoptosis. In this proposal, the investigators will focus on exploring key~     mechanism(s) that potentially regulate islet cell plasticity in altered glucose metabolic~     states.~      Investigators will explore in a unique cohort of individuals who undergo duodenal~     pancretectomy. Prior to their surgery will be performed in vivo studies (Hyperglycemic clamp,~     Euglycemic Hyperinsulinemic clamp and Mixed Meal Tests) to accurately assess glucose~     homeostasis parameters to classify each individual into metabolic phenotypes. Then exploit~     the opportunity to collect pancreas samples from these patients who will be evaluated again~     after surgery, the investigators will determine the ability of the remnant pancreas to~     compensate for the acute reduction in islet mass and perform correlations between ex vivo and~     in vivo parameters.~      Specifically, the patients will be subjected to incretin secretion (mixed meal), metabolic~     status (OGTT), insulin secretion characteristics (first and second phase responses), β-cell~     insulin content evaluation (arginine bolus). Subsequently, pancreas samples will be evaluated~     for morphometry, and proteomics and gene expression analyses of islet cell samples obtain by~     laser capture will allow a detailed investigation of mechanisms that contribute to islet~     plasticity. The overall goal of this project is to investigate key mechanisms driving the~     ability of islet mass to adapt to diverse metabolic states. We aim to explore modifications~     in gene expression and proteomics and correlate them with specific metabolic phenotypes, in~     order to determine key regulators of islet morphology.~   "
106342|NCT02175446|"~     In the second-line treatment setting for MBC, many agents, including antitubulin drugs~     (Taxanes, Vinorelbine) and antimetabolites (Capecitabine, Gemcitabine), have demonstrated~     activity, but no agent is clearly superior. Although some combinations of cytotoxic agents~     provide a small progression-free survival advantage, none has demonstrated an OS advantage,~     and toxicity is generally greater than for single agents. At present, there is no standard~     for this treatment setting. New treatments that could delay disease progression without~     systemic toxicity would represent a significant advancement.~   "
106343|NCT02175433|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of~     AGS67E both without and with myeloid growth factor (GF) in subjects with refractory or~     relapsed lymphoid malignancies. Immunogenicity and anticancer activity of AGS67E will also be~     assessed.~   "
106344|NCT02175420|"~     The BCG (bacillus Calmette-Guerin) vaccine is used for the protection against tuberculosis.~      Apart from it's protective effect against tuberculosis BCG vaccine has been shown to have~     non-specific effects on the innate immune system and is in epidemiological studies associated~     with reduced mortality due to infectious diseases.~      Several studies have shown that BCG can boost the effect of other vaccines. The present study~     aims to investigate the boosting effect of BCG on the response to typhoid fever vaccine (TFV)~     and to assess the non-specific effects of BCG on the innate immune system at early timepoints~     by vaccinating volunteers with either TFV alone or BCG followed by TFV 14 days later.~      The study hypothesis is that when BCG is given 14 days before typhoid fever vaccine a better~     vaccination result in terms of antibody production will be accomplished against typhoid fever~     due to the effects of BCG on the innate immune system.~   "
106345|NCT02175407|"~     The purpose of this study to explore the effect of multiple oral doses of itraconazole on the~     pharmacokinetics of a single oral dose of ASP1707 in healthy female subjects. This study will~     also evaluate the safety and tolerability of a single oral dose of ASP1707 alone and in~     combination with itraconazole.~   "
106346|NCT02175394|"~     The objective was to investigate the effect of multiple oral doses of 5 mg BI 1356 on the~     steady-state pharmacokinetics of ethinylestradiol (EE) and levonorgestrel (LNG), the~     components of Microgynon®~   "
106347|NCT02175381|"~     The investigators propose to study the safety and efficacy of the combination of Carboplatin~     plus Gemcitabine in a Phase I/II trial of elderly subjects with non-small cell lung cancer.~   "
106354|NCT02175290|"~     Machado-Joseph disease (MJD) or spinocerebellar ataxia type 3 (SCA-3) is the most common~     dominant ataxia. The genetic cause of this late-onset degenerative disorder is the expansion~     of a (CAG)n tract located in the exonic region of the ATXN3 gene. In 1994 the first case of~     MJD among the Yemenite Jewish subpopulation living in Israel was published. The puropse of~     this study is to describe the clinical phenotype and genotype of the Yemenite Jewish~     subpopulation with MJD living in Israel~   "
106355|NCT02175277|"~     This is a phase 3b, multi-centre, open-label, single-arm companion study to the MDS 20090160~     study for the treatment of anaemic subjects with MDS. Subjects that complete the~     active-treatment period of the darbepoetin alfa MDS 20090160 study and meet the eligibility~     criteria may be enrolled into this study to continue treatment of darbepoetin alfa for up to~     73 weeks or until progression to acute myelogenous leukemia (AML), whichever occurs first.~   "
106356|NCT02175264|"~     In isolated congenital diaphragmatic hernia (CDH), recurrent risk is low suggesting the~     occurrence of novo mutations (dominant or recessive). Our objective is to test this~     hypothesis by combining the search for pathogenic genomic alteration and intragenic mutations~     through whole exome sequencing in a homogenous group of patients.~   "
106357|NCT02175251|"~     Auditory Hallucinations (AH) are experienced by 50 to 70% of subjects with schizophrenia.~     Almost a quarter of patients are medication resistant to such symptoms. The application of~     rTMS at low frequency in the left temporoparietal cortex reduces AH. A pilot study reported~     successful treatment of AH with high frequency rTMS. rTMS (20Hz) should be a shorter and an~     easier treatment for out-patients with schizophrenia compared to low stimulation treatment.~   "
106358|NCT02175238|"~     The primary objective of this trial is to investigate the relative bioavailability and~     pharmacokinetics in plasma and whole blood of BI 691751 administered as a single dose with~     and without food in healthy male subjects.~   "
106359|NCT02175225|"~     The investigators hypothesize that treatment with the iron chelator, Deferoxamine Mesylate,~     improves the outcome of patients with brain hemorrhage.~      The purpose of this study is to determine whether treatment with Deferoxamine Mesylate is of~     sufficient promise to improve outcome before pursuing a larger clinical trial to examine its~     effectiveness as a treatment for intracerebral hemorrhage.~   "
106360|NCT02175212|"~     The present study is a phase III randomized and multicentric trial evaluating the potential~     additional impact effect of two years adjuvant androgen deprivation when combined with~     neoadjuvant (4 months) and high-dose (76 Gy) conformal radiotherapy in moderate high-risk~     prostate cancer patients. Stratification will be performed by prognostic factors and by~     participating institution.~   "
106361|NCT02175199|"~     The purpose of this study is to evaluate the comfort of color contact lenses in a population~     of clear contact lens wearers who have an interest in wearing color contact lenses.~   "
106362|NCT02175186|"~     The purpose of this study is to evaluate effectiveness of ALBIS on Gastroduodenal Mucosal~     Injury in Patients Receiving Dual Antiplatelet Therapy after Percutaneous Coronary~     Intervention.~   "
106363|NCT02175173|"~     This surveillance's objectives are~        1. Unknown adverse reactions~        2. Incidences of adverse drug reaction~        3. Efficacy during long-term administration~        4. Factors considered to have effect to safety and effectiveness~        5. Incidences of status epileptics, skin disorders and hyper sensitivity reaction, and~          central nervous system-related adverse events(ataxia , somnolence and/or dizzy, etc.)~   "
106364|NCT02175160|"~     Several studies exist on patient performance in drive simulators especially around and after~     surgery. Recommendations concerning the ability to drive preoperatively are based on these~     studies, which generated their data using drive simulators. However, in all the datasets~     driving performance remains highly individual. Since a drive simulator is not readily~     available in normal general practitioner surgeries it would be helpful to have convenient~     clinical tests to evaluate a patients individual ability to perform an emergency stop. This~     study aims at evaluating different possibilities how such performance might be predicted.~     Patients with knee osteoarthritis and patients who have received total knee arthroplasty are~     tested clinically and their results are compared with the gold standard experiment - a drive~     simulator.~   "
106365|NCT02175147|"~     Rationale: Palliative care integration in treatment pathways, palliative care networks and~     institutional collaborations in health services delivery seems a promising approach reducing~     fragmentation and discontinuity. Integrated Palliative Care (IPC) approaches in Europe are~     largely unknown and under-investigated. The investigators aim is to explore experiences of~     patients with advanced cancer, Chronic Obstructive Pulmonary Disease (COPD) and Chronic Heart~     Failure (CHF), family and professional caregivers within with IPC. This includes perceived~     quality of life, quality of care, burden/rewards of care giving, symptoms and collaboration~     between caregivers in the patient's care network.~      Objectives: To investigate how patients with advanced cancer, COPD and CHF, their family and~     professional caregivers within a selection of IPC initiatives in Belgium, Germany, Hungary,~     The Netherlands and United Kingdom experience care delivery in the last phase of disease.~        -  To investigate what opinions patients and family caregivers have on the (continuity and)~          quality of care delivered~        -  To investigate how patients rate their symptoms and quality of life~        -  To investigate how family caregivers rate their burden / rewards of care giving~        -  To investigate how the care network of the patient is organised with respect to the~          type, properties and quality of relationships between patients and family / professional~          caregivers~      Study design: Longitudinal multiple embedded case study.~      Study population: Adult patients with advanced cancer, COPD, and CHF under the care of IPC~     initiatives in five participating countries, their family and professional caregivers. The~     investigators aim to enroll up to 288 patients, 288 family caregivers and 192 professional~     caregivers in total.~      Study parameters: Experiences with IPC initiatives, quality of care, quality of life,~     perceived symptoms, perceived collaboration between professional caregivers, burden and~     rewards of care giving.~      Methods: Semi-structured interviews, patient diary, Social Network Analysis and the following~     questionnaires: Palliative care Outcome Scale; Canhelp Lite, Caregiver Reaction Assessment.~     Patients and family caregivers will be followed over 3 months at 4 consecutive contact~     points. The diary (containing two questions) will be kept weekly by patients. There will be~     group or individual interviews with professional caregivers.~      Analysis: The overall analysis will involve a synthesis of the qualitative and quantitative~     data. For more information see Detailed Description.~   "
106366|NCT02175134|"~     The diagnosis of tuberculous peritonitis (TBP) is still challenging, and largely dependent on~     invasive procedures such as laparoscopy. A recently developed RD-1 gene-based assay for~     diagnosing TBP shows has given promising results. The investigators thus created a 2-step~     algorithm using the Blood/Ascites ELISPOT assays and adenosine deaminase (ADA) in ascites for~     differentiation of TBP from other diagnoses (Blood ELISPOT ≥6 spots or ADA ≥ 21 U/L' as a~     rule-out test and 'Ascites/Blood ratio ≥3' as a rule-in test). This study is the randomized~     controlled trial on whether this 2-step algorithm-based approach can reduce the laparoscopic~     biopsy for the diagnosis of TBP in patients with suspected TBP.~   "
106367|NCT02175121|"~     This study is going to assess the safety and tolerability of PF-06291874 in adults with Type~     2 Diabetes Mellitus as monotherapy, to evaluate the significance of overall glycemic control~     in these subjects.~   "
122039|NCT01970098|"~     The purpose of this study is to investigate the superiority of KPS-0373 to placebo, and~     evaluate the safety and pharmacokinetics of KPS-0373 in SCD patients.~   "
106370|NCT02175082|"~     The purpose of this study is to assess the effectiveness of a forced exercise aerobic~     exercise program, utilizing a cycling activity, on specific gait parameters and balance in~     individuals with Parkinson's Disease (PD). Design: pilot, feasibility, randomized control,~     evaluator blinded. Subjects: Twenty four patients with idiopathic PD Hoehn and Yahr (H&Y)~     stage II or III. Intervention: Participants randomly assigned to one of two exercise groups,~     forced exercise or self selected exercise, on cycling machine three times a week for 8 weeks.~     Both groups to exercise at same aerobic intensity level to keep heart rate at 60-80% heart~     rate max. Outcomes: Gait parameters of step length, width, and variability as measured by the~     GAITRite; 6 Minute Walk Test; mini-BESTest (balance testing); exercise tolerance via Patient~     Reported Outcomes Measurement Information System (PROMIS) scale.~   "
106371|NCT02175069|"~     Interscalene plexus block is a widely used technique to provide anesthesia and analgesia for~     surgery at the upper extremity (shoulder and upper arm); it is standard-of-care in many~     institutions worldwide. Local anesthetic is being injected around the nerves supplying the~     arm (Plexus brachialis) at a specific location in the arm (between the scalenus muscles, thus~     called interscalene plexus block). The optimal volume of injection with regard to efficacy,~     safety and avoidance of untoward effects has been subject to intense debate for a long time.~     In spite of evidence that small volumes (between 5 and 7 mls) are effective for adequate~     postoperative analgesia, larger volumes up to 40 mls are still frequently used in many~     practices. However, with the use of such large doses, adverse events are known to occur with~     increased frequency, including paralysis of the diaphragm or spread of local anesthetic to~     the spinal cord.~      This study is intended to help evaluate the effects of small or larger injection of local~     anesthetic around the brachial plexus, and to correlate the distribution with clinical~     efficacy, block duration, and possible side effects. It is a randomized, controlled,~     observer-blinded trial; patients undergoing shoulder or upper arm surgery will be randomly~     allocated to receive either 5mls or 20mls of local anesthetic for their interscalene plexus~     block. Magnetic resonance imaging will be performed immediately afterwards, followed by a~     series of neurological exams during the hospital stay. Test of lung function (spirometry) and~     ultrasound of the diaphragm will be used to evaluate effects of the block on respiratory~     mechanics.~   "
106372|NCT02175056|"~     The study design of this trial is a Dose-Block Randomized, Placebo controlled (Double-blind),~     Active Controlled(Open-label), Dose-escalation.~   "
106373|NCT02175043|"~     1. Purpose of the study~      1) To compare clinical outcome, procedure time, complication rate of persistent atrial~     fibrillation patients between conventional additional linear ablation and additional complex~     fractionated atrial electrogram targeted catheter ablation.~      2. Scientific evidence of the study~        1. In atrial fibrillation patients, the maintenance of normal sinus rhythm showed~          significant reduction of mortality.~        2. drug therapy with anti-arrhythmic drug showed many complications and side effect, thus~          non-drug therapy such as catheter ablation is developed.~        3. catheter ablation has been performed for 10years world-wide, and showed superior~          treatment outcome compared with drug therapy.~        4. However, there are no consensus for proper ablation strategy in longstanding persistent~          atrial fibrillation.~        5. additional ablation make extent of myocardial injury and paradoxically increase~          recurrence rate, thus still controversial.~        6. Therefore, we will compare conventional linear ablation with additional complex~          fractionated atrial electrogram targeted catheter ablation.~      3. Methods~        1. Treatment of All patients with atrial fibrillation is performed according to the~          standard treatment guideline of atrial fibrillation.~        2. there is no additional blood sampling, imaging study, or any other invasive procedure~          according to the inclusion of the study.~      4. study contents~        1. to evaluate superior ablation strategy in longstanding persistent atrial fibrillation~             -  compare conventional linear ablation with additional complex fractionated atrial~               electrogram targeted catheter ablation. both strategies are conventional ablation~               strategies being performed world-wide.~        2. compare complex fractionated atrial electrogram before and after linear ablation.~   "
106374|NCT02175030|"~     This study is a randomized trial of two IUDs for emergency contraception: the copper IUD, the~     most effective method of emergency contraception vs. the levonorgestrel IUD, the most~     preferred IUD which has never been tested as an emergency contraceptive. This research has~     the potential to increase use of highly effective contraception in a high-risk population and~     lower the persistently elevated rate of U.S. unintended pregnancy.~   "
106375|NCT02175017|"~     The objective of the study is to investigate the efficacy and safety of ONO-4538 in subjects~     with stage IIIB/IV or recurrent non-small cell lung cancer unsuited to radical radiotherapy~     and resistant to a platinum-based chemotherapeutic regimen.~   "
106376|NCT02175004|"~     This study evaluates the safety and tolerability of extended dosing with IONIS-TTR Rx in~     patients with Familial Amyloid Polyneuropathy.~   "
106377|NCT02174991|"~     A. To evaluate the ocular hypotensive efficacy of the rho-kinase Inhibitor (AR-12286 0.5% and~     0.7%) ophthalmic solutions in open-angle glaucoma patients with uncontrolled IOP who are~     facing surgical intervention. Patients will be treated for 6 months in this initial trial.~      B. To evaluate the efficacy of AR-12286 in enabling treated patients to delay or avoid the~     necessity of surgical intervention.~   "
106378|NCT02174978|"~     The proposed study is a Phase 1 study with controlled human malaria infection (CHMI) designed~     primarily to evaluate the safety of the FMP012 combined with AS01B adjuvant system. AS01B is~     a proprietary current good manufacturing practices (cGMP) grade adjuvant manufactured by~     GlaxoSmithKline (GSK) Biologicals. It is a formulation based on liposomes mixed with the~     immunostimulants monophosphoryl lipid (MPL) and Quillaja saponaria (QS)-21. The~     immunogenicity and efficacy of this new candidate vaccine will be evaluated in addition to~     safety.~   "
106379|NCT02174965|"~     The primary objective of this study is to determine whether the Mini Hip (Corin, U.K.)~     femoral component has a predictable and stable migration pattern (mean migration of the~     femoral component in three-dimensions,in mm) over a three year period, compared to a~     conventional cementless stem (Metafix, Corin, U.K.). The secondary objectives of this study~     are to determine whether the Trinity (Corin, U.K.) acetabular component has a predictable and~     stable migration pattern over a three year period and to measure the linear wear of femoral~     head into the ECIMA Highly Cross-linked polyethylene.~   "
106413|NCT02174523|"~     To evaluate the pharmacokinetic (PK) characteristics after multiple oral administration of 40~     mg lurasidone in healthy Chinese subjects.~      To evaluate the safety and tolerance after multiple oral administration of 40 mg lurasidone~     in healthy Chinese subjects.~   "
106414|NCT02174510|"~     To evaluate the pharmacokinetic (PK) characteristics of lurasidone after single oral~     administration of different doses in healthy Chinese subjects.~      To evaluate the safety and tolerability of lurasidone after single oral administration of~     different doses in healthy Chinese subjects.~   "
106415|NCT02174497|"~     This was a blinded study conducted on the efficacy and safety of a one-day versus a three-day~     bowel preparation in a pediatric population. Limited data is available in this regard, and~     this study supports the use of a one-day bowel preparation, as this is both safe and~     effective.~   "
106380|NCT02174952|"~     Therapist-led parenting interventions have been shown to reduce symptoms of attention deficit~     hyperactivity disorder (ADHD) and are recommended as a first line treatment for school age~     children with ADHD. However, parenting interventions can be costly and impractical for~     parents due to factors such as time constraints and travelling costs. A self-help parent~     training manual has been developed and initial results have shown moderate reductions in ADHD~     symptoms, indicating that whilst self-help may offer a cost effective alternative to~     therapist led parent training interventions, it may not be sufficient to treat ADHD alone.~     This study therefore aims to compare the efficacy and additional benefits of the self-help~     intervention plus treatment as usual including pharmacotherapy with a control treatment as~     usual group . Families with a child aged 6-10 with a clinical diagnosis of ADHD will be~     recruited to the study via referrals from community paediatricians and child and adolescent~     mental health services. After gaining informed consent subjects will be randomised to~     self-help plus Treatment as usual (TAU) + or TAU (control). Those allocated to TAU+SH will be~     issued with the self-help manual and an introductory DVD to highlight key aspects of the~     intervention. Self-help intervention will last for 12 weeks. Data will be collected via~     standardised questionnaires completed by the parent, teacher and child and a recorded speech~     samples from the parent. Data will be collected at three time points; pre-intervention,~     post-intervention (12 weeks) and as a long term follow up (28 weeks). After completing the~     trial, qualitative data will be collected about participants' experience of self-help~     intervention.~   "
106381|NCT02174939|"~     1. The number and function of circulating endothelial progenitor cells (EPCs) are inversely~          associated with coronary risk factors and atherosclerotic diseases such as coronary~          artery disease (CAD) and cardiovascular high risk.~        2. This double-blind, randomized, placebo-controlled trial to evaluate the effects of~          cilostazol on human early EPCs and endothelial function as well as the potential~          mechanisms of action in patients with CAD and cardiovascular high risk.~   "
106382|NCT02174926|"~     The purpose of this study is to find out whether elective sigmoid resection will improve~     quality of life compared to conservative treatment with lifestyle guidance and fiber~     supplement in patients with a recurrent or complicated diverticulitis.~   "
106383|NCT02174913|"~     BIS is one of several equipments used to monitor depth of anesthesia.Some studies found BIS~     can reduce total propofol dose when being used with TCI.The objective is to compare awakening~     time after spine surgery between using clinical signs and bispectral index (BIS) guided~     target controlled infusion(TCI) of propofol in patients having neurophysiologic monitoring.~   "
106384|NCT02174900|"~     The purpose of this study is to evaluate the tolerability and safety of increasing doses of~     primaquine in combination with artemether-lumefantrine in G6PD deficient males with an~     asymptomatic P. falciparum malaria infection.~   "
106385|NCT02174887|"~     The prognostic of metastatic pancreatic adenocarcinoma is dismal and the treatment gold~     standard since the end of the 90s' is gemcitabine; unfortunately all trials testing~     combinations of gemcitabine with chemotherapeutic agents or targeted agents had failed to~     demonstrate any superiority over gemcitabine monotherapy.~      In a recently published phase I/II study of combination of gemcitabine plus nab-paclitaxel in~     patients with metastatic pancreatic adenocarcinoma (PAC), the combination gave an impressive~     response rate of 48% (Gemcitabine 1g/m² and nab-paclitaxel 125 mg/m² once a week for 3 weeks,~     every 4 weeks). The safety profile was correct (fatigue, sensory neuropathy, nausea,~     haematological side effects). This efficacy can be related to an improvement of gemcitabine~     delivery to the tumor bed, as shown on preclinical studies: the response rate in xenografts~     was better with the combination; this improvement was associated with an increase of~     intratumoral gemcitabine concentration in mice receiving the combination when compared to~     mice receiving gemcitabine alone. This might be associated to modifications of peritumoral~     stroma with reduction of stromal content and increase in dilated vessels.~      The aim of this study is to evaluate if the combination of nab-paclitaxel plus gemcitabine~     induces a modification in vascularization of pancreatic adenocarcinoma on the primary tumor~     and of liver metastases after 2 cycles of treatment by comparison to baseline.~   "
106386|NCT02174874|"~     In children aged 3 months to 10 years who present to the Pediatric Emergency Department (PED)~     with recent, significant vomiting and moderate dehydration, is treatment with Ondansetron~     Orally Disintegrating Tablet (ODT) better tolerated than treatment with Ondansetron Oral~     Solution (OS)? Our hypothesis is that children who receive Ondansetron ODT will have 10% less~     vomiting within 15 minutes of administration than those receiving Ondansetron OS.~   "
106387|NCT02174861|"~     To assess the long-term safety and efficacy of AMG 334 .~   "
106388|NCT02174848|"~     Patients with PKAN will be treated with the iron chelator deferiprone for 18 months. Only~     patients who have completed the earlier study TIRCON2012V1 (a double-blind placebo-controlled~     trial in which participants were randomized to receive either deferiprone or placebo for 18~     months) are eligible to enroll.~   "
106389|NCT02174835|"~     To assess the multiple-dose pharmacokinetics (PK), safety and tolerability of AVP-786~     (deuterated [d6] dextromethorphan hydrobromide [DM]/quinidine sulfate [Q]) in healthy~     volunteers.~   "
106390|NCT02174822|"~     To assess steady state pharmacokinetics (PK), safety and tolerability between AVP-786~     (deuterated [d6] dextromethorphan hydrobromide [DM]/quinidine sulfate [Q]) and paroxetine and~     between AVP-786 and duloxetine.~   "
106416|NCT02174484|"~     The purpose of the PREMS study is to evaluate the capability of the periodic IEGM feature~     (intracardiac electrogram) to provide more extensive remote information about cardiac rhythm,~     sensing and capture, and thus to detect anomalies that may deserve a clinical action.~      PREMS is a non-interventional, prospective, and multicenter study. The primary objective is~     to assess the added clinical value of periodic IEGMs, based on the rate of patients with a~     rhythm or sensing/pacing anomaly detected on the first IEGM transmitted by Home Monitoring~     (HM) and non detectable so obvious on the other parameter set offered for the remote~     follow-up.~   "
106418|NCT02174458|"~     Body contouring (BC) surgery after major weight loss (MWL) requires extensive and multiple~     procedures. Yet, there are inconsistent data regarding the outcome after BC procedures. The~     aim of this study is to investigate the outcome from patients who elect to have BC procedures~     after MWL treated at a single metropolitan tertiary referral center.~   "
122040|NCT01970072|"~     The purpose of this study is to evaluate and compare the Pharmacokinetics/Pharmacodynamics~     and safety of Remimazolam Tosylate with midazolam in healthy volunteers~   "
106391|NCT02174809|"~     Excess weight gain in pregnancy is linked to a number of adverse outcomes for mothers and~     their offspring, and in 2011, 59 % of women in Nova Scotia gained weight in excess of~     recommendations. A number of factors influence how much weight a woman gains, including lack~     of knowledge, age, the number of previous pregnancies she's had, smoking, ethnicity, income,~     and education. Although a clinician's advice also plays a role, simply giving advice does not~     necessarily translate into patient behaviour change. On the other hand, advice that is given~     through a patient-centred approach is significantly associated with increased patient~     acceptance of and adherence to recommendations, and increased intentions and attempts at~     behaviour change. In addition, this approach has been shown to decrease costs to the health~     care system. Patient-centredness can measured from the perspective of the clinician, an~     observer, or the patient. Research suggests that the patient's perspective of~     patient-centredness is the perspective most significantly associated with improved health~     outcomes.~      Clinicians avoid discussing weight-related matters for a number of reasons, including a lack~     of time and general discomfort in raising the subject. There are some tools that can address~     some of these barriers, and example being the 5As of Obesity Management. This tool is based~     on principles of behaviour change science and patient-centredness. Pilot data on the use of~     this tool showed a two-fold increase in the initiation of weight-related discussions between~     clinicians and their patients. Our team was instrumental in the development, dissemination~     and initial evaluation of this tool, and Dr. Piccinini-Vallis has recently led a national~     multidisciplinary endeavor to adapt it to pregnancy, which has resulted in the 5As of~     Healthy Pregnancy Weight Gain tool. It is now time to evaluate whether the use of this tool~     is acceptable to clinicians and whether its use translates into any patient outcomes.~   "
106392|NCT02174796|"~     this non-randomized prospective study of 2 longitudinal cohorts (surgical treatment group or~     orthopedic treatment group), will evaluate the hemodynamic repercussions of the correction~     (surgical and non surgical) of pectus excavatum-type thoracic deformities by measuring the~     cardiac output difference before and after intervention, measured by transthoracic~     impedancemetry, during an exercise stress test~   "
106393|NCT02174783|"~     Many metabolic complications can develop after liver transplant including: diabetes, high~     blood pressure, obesity, heart attacks and stroke. The goal of this study is to look at the~     safety and effect of 2 well known and established diet regimens on the people who had a prior~     liver transplant and investigate whether it helps with the control of these comorbidities.~   "
106394|NCT02174770|"~     Occlusion training, resistance exercise performed with a specialized venous tourniquet, leads~     to beneficial changes in muscle at low resistance and minimal stress on the nearby joint.~     This novel resistance training has the potential to greatly improve extremity muscle strength~     gains for rehabilitation patients who are unable for medical reasons to perform high~     resistance exercise. Our study will explore this with specific rehabilitation populations:~     post-operative knee scopes, post-operative anterior cruciate ligament (ACL) reconstruction~     patients who have acute post-operative changes in thigh muscle function and chronic thigh~     weakness. The primary outcome is to achieve accelerated functional thigh recovery with~     outcome measures including thigh strength, validated questionnaires, and validated functional~     testing. Occlusion training can enhance rehab patients outcomes, reduce the cost of care, and~     improve the skills and efficiency of care providers.~   "
106395|NCT02174757|"~     Periodontitis is a multifactorial disease that can lead to the destruction of supporting~     tissues of the teeth resulting in pocket formation, recession or both. Since the primary~     etiological factors for periodontal disease are bacteria in supra and sub gingival biofilm,~     efforts for disease prevention and treatment are mainly focused on pathogen reduction and~     strengthening of epithelial barrier, thus contributing to decreased susceptibility to~     infection. Due to emergence of antibiotic resistance and frequent recolonization of treated~     sites with pathogenic bacteria, there was need for a new treatment paradigm to be introduced~     to periodontal disease. The need was fulfilled by the introduction of Probiotics and~     Bacterial Replacement Therapy. The term probiotic is derived from the Greek, meaning for~     life are microorganisms proven to exert health promoting influences in humans and animals.~     Food and Agriculture Organization and WHO have stated that there is potential for probiotic~     foods to provide health benefits and that specific strains are safe for human use.~   "
106396|NCT02174744|"~     The pain of the elderly is often trivialized and ignored in spite of its high frequency: the~     chronic pain affects 50 % of the elderly living at home, 49 to 83 % of those living in~     institution and 80 % of this population at the end of life.~      The evaluation of pain appeals to the same strategy as to the younger subject but with some~     specificities, related more to the pathologies associated with the ageing than to the real~     age. For that purpose, the investigators have self-assessment scales as the Numeric Pain~     Rating Scale which is adapted to estimate acute and chronic pains, but this scale presents a~     bias because, some patients do not express spontaneously their pain.~      So behavioural scales were elaborated to solve the difficulties of detection and to care the~     pain of the elderly. The Algoplus® scale (5 items which takes less than one minute to be~     completed) whose objective is the observation of behavioural changes caused by the acute pain~     in elderly having communication disorders. The Doloplus® scale (30 items which allow in few~     minutes a good evaluation of pain) whose objective is the observation of behavioural changes~     caused by the chronic pain in elderly having communication impairments.~      In practice, because of its popularity, the Algoplus® scale is widely used out of the~     specificity in which it has been validated. Practitioners, worried about this misuse,~     suggested to Doloplus® group, to test the concordance between the two behavioural scales in~     order to develop recommendations more targeted. The risk is that the use of the Algoplus®~     scale may underestimate pain that would have been detected by Doloplus® scale, and lead to~     under-treatment or non-treatment of pain in elderly having communication disorders.~      This study aims to establish the concordance between these two scales to generate advices and~     recommendations to assess efficiently the pain in this vulnerable population.~      The main objective of this study is to assess whether the use of Algoplus® scale is in good~     concordance with Doloplus® scale.~      The secondary objective of this study is to assess the concordance with different levels of~     Algoplus® pain scale: (0-1), (2-3), (4-5).~   "
106397|NCT02174731|"~     The purpose of this study is to evaluate the efficacy and safety of roxadustat compared to~     epoetin alfa for the treatment of anemia in chronic kidney disease patients on dialysis~   "
106398|NCT02174718|"~     A clinical need exists for non-oral vitamin D administration. This study is designed to test~     a new proprietary transdermal system. It is looking to see if this new system will safely and~     successfully deliver vitamin D3 to humans.~   "
106399|NCT02174705|"~     This randomized trial will compare the analgesic effectiveness of oral rotavirus vaccine to~     sugar water for reducing vaccine injection pain in infants.~   "
106417|NCT02174471|"~     Aortic stenosis (AS) is the most common valvular heart condition in the United Kingdom and~     the Western world. Surgery for severe AS prior to symptom onset is controversial.~     Conventionally changes in valve area and gradient are used to time intervention but~     myocardial changes may be more predictive of surgical need.~      This study aims to elucidate the role of diffuse myocardial fibrosis as a prognostic marker,~     implementing a novel, non-invasive MRI technique to measure it.~      Design: The investigators will measure diffuse myocardial fibrosis in 150 patients with~     severe narrowing of the aortic valve before and one year after valve replacement. Expected~     outcomes: Diffuse myocardial fibrosis measured by MRI scanning will predict outcome after~     surgery in aortic stenosis. Anticipated Health Benefits: Identify patients with higher post~     operative morbidity and mortality, who may benefit from earlier valve replacement.~   "
106419|NCT02174445|"~     This is an open-label, multicenter, randomised phase 3b clinical trial of Imatinib 400 to 800~     mg daily versus Nilotinib 300 mg two times daily in chronic phase CML patients with confirmed~     MMR without MR4.5~   "
106400|NCT02174692|"~     The aim of this study is to understand how healthy muscle repairs in response to eccentric~     exercise by evaluating functional, metabolic and molecular measures. Furthermore, this study~     will aim to understand the repair mechanisms in elderly healthy muscle following eccentric~     exercise by evaluating the same measures and highlighting age-related differences in repair~     mechanisms which may account for the age-related loss in muscle mass. It is hypothesised that~     elderly muscle will have a lesser/ blunted repair process compared to young muscle.~      To meet the aims of this study and to answer the hypothesis, this study protocol is as~     follows:~      Baseline functional, metabolic and molecular values are obtained via functional testing and a~     muscle biopsy. Participants then perform eccentric exercise designed to induce functional~     decline and muscle soreness and the contralateral leg performs concentric exercise which~     isn't designed to induce soreness or functional decline. Using a time-course, various~     metabolic and molecular measures are taken prior to and up to 7 days post exercise to~     understand the mechanisms underlying muscle repair. In addition the use of a novel amino acid~     tracer (D2O) will allow for synthesis measures over the duration of the study rather than the~     typical tracer techniques which only capture ~12 hours of synthesis.~   "
106401|NCT02174679|"~     To evaluate 68Ga-DOTATATE PET/CT for staging of patients with carcinoid, neuroendocrine~     tumors, medullary thyroid cancer and other cancers expressing somatostatin receptors.~   "
106402|NCT02174666|"~     The aim of the project is to execute a double-blind, parallel, randomized 12-month~     intervention trial on postmenopausal women with osteopenia (low bone mineral density), in~     order to determine the effects of daily intake of fermented red clover (RC) extract on~     estrogen dependent bone mineral resorption when compared to placebo. Both groups will recieve~     equivalent daily calcium, vitamin D and magnesium supplements. The project will also assess~     whether bioactive compounds in RC can reduce the risk of developing cardiovascular disease.~   "
106403|NCT02174653|"~     The aim of the study is to evaluate the safety of the intake of EPs® 7630 during a long-term~     (4 months) medication. The protective effects of EPs®7630 and its effects during a cold~     episode will also be studied.~   "
106404|NCT02174640|"~     The primary objective is to test if acute supplementation with Coffee would improve~     antioxidant status, following consumption of a pro-oxidative high carbohydrate, high fat meal~     in over weight/ obese humans.~      Secondary objective is to determine the ability of coffee to modify postprandial inflammation~     in overweight/ obese humans.~   "
106405|NCT02174627|"~     The purpose of the study is to evaluate the safety and efficacy of roxadustat for treatment~     of anemia in patients with chronic kidney disease not on dialysis.~   "
106406|NCT02174614|"~     The investigators are conducting a randomized clinical trial of rapid abstinence initiation~     and cognitive control training as a precursor to our new web-based version of the CBT4CBT~     (Computer Based Training for Cognitive Behavioral Therapy) program to evaluate its~     effectiveness relative to standard outpatient counseling at the Midwestern Connecticut~     Council of Alcoholism (MCCA). CCT will be used to assess attention, working memory and~     inhibitory control and the computer-based training program (CBT4CBT) focuses on teaching~     basic coping skills, presenting examples of effective use of coping skills in a number of~     realistic situations in video form, and providing opportunities for patients to practice and~     review new skills while receiving cocaine abuse treatment.~   "
106407|NCT02174601|"~     After written consent for participating in clinical research studies, all clinical studies~     conducted to in the one day. The investigators will ask and record about bowel cleansing~     state in all patients who performed colonoscopy. There is no additional cost and the expected~     complications.~      Based on answer, the investigators will develop a prediction model for inadequate bowel~     preparation and prove validation. This model can take the additional measures to subjects~     predicting improper cleansing. It can contribute to improve the accuracy of the test and~     reduce the discomfort due to re-performing colonoscopy after re-preparation, as well as cost~     savings due to reduced frequency of re-colonoscopy Ultimately, it will be able to bring a~     improvement of the quality of management~   "
106408|NCT02174588|"~     Since introduction in 1989, propofol has gained wide acceptance for sedation during~     endoscopic procedures. The optimal sedation drug during esophagogastroendoscopy (EGD) is not~     established. Midazolam and propofol are used for sedation drug. Balanced propofol sedation~     (BPS) refers to the administration of an opiate, a benzodiazepine, and propofol. In this~     study, the investigators want to compare the patient satisfaction with EGD following balanced~     propofol sedation (BPS) versus propofol sedation alone.~   "
106409|NCT02174575|"~     -  It has been shown that patients who undergo liver resection surgery are at high risk for~          postoperative acute kidney injury (AKI).~        -  Sevoflurane may increase the risk for postoperative AKI because of production of~          compound-A.~        -  Therefore, we have planned to investigate the effects of different anesthetic agents on~          postoperative renal function.~        -  Patients undergoing liver resection surgery are randomized into 2 groups.~        -  One of the groups receives sevoflurane and the other group receives desflurane.~        -  Blood and urine specimen are sampled both pre- and postoperatively, and several~          biomarkers are compared between the groups.~   "
106410|NCT02174562|"~     This research aims to help older African Americans with diabetes and mild memory problems~     improve how they take their medications and control their diabetes. This may preserve their~     independence and health, prevent cognitive and functional decline, and reduce health care~     costs. As the population ages and becomes more racially diverse, finding ways to achieve~     these outcomes has great public health importance.~   "
106411|NCT02174549|"~     This phase 1 study is to determine the optimal dose and tolerability of a hypoxia-activating~     agent, tirapazamine, when it is combined with embolization in liver cancer. Liver cancer~     patients who are Child-Pugh score A, suitable for embolization with tumor no more than 4~     nodules are eligible. Tirapazamine will be given by intra-arterial injection before~     embolization. Treatment effect is evaluated by MRI based on mRECIST criteria. Repeat~     treatment is necessary only if disease progression. Expansion cohorts are open for metastatic~     gastrointestinal cancer and neuroendocrine tumor.~   "
106412|NCT02174536|"~     A prospective double blind randomized study comparing placenta derived decidual stromal cells~     with placebo for hemorrhagic cystitis after allogeneic hematopoietic cell transplantation. It~     is hypothesized that the decidual stromal cell therapy will be superior to placebo.~   "
106421|NCT02174419|"~     The primary objectives of the study are to evaluate the effects of two doses of nalbuphine~     HCl ER tablets on the change from baseline in the worst itch Numerical Rating Scale (NRS) in~     patients with prurigo nodularis and to evaluate the safety and tolerability in the study~     population.~   "
106422|NCT02174406|"~     The purpose of this study is to determine whether ultrasound or Digital breast tomosynthesis~     (DBT) detects more cancers and to compare the types of cancers detected on ultrasound and~     DBT.~   "
106423|NCT02174393|"~     Acne is a prevalent disorder mostly witnessed in adolescents, but can be seen in adults.~     Early treatment is imperative to reduce acne scarring which can appear with atrophic lesions,~     and depending on the skin type, significant erythema (redness) or post-inflammatory~     hyperpigmentation. A multi-modality approach to treatment is necessary when dealing with the~     aforementioned types of lesions. Pharmacologic management is essential, but safe procedural~     therapies are also necessary specifically with darker skinned individuals.~      Percutaneous collagen induction therapy (PCIT) is a non-invasive treatment achieved by using~     a micro-needling device, which is safe and effective in causing micro-wounds into the~     dermis thereby initiating wound healing followed by collagen production. This is an ideal~     treatment for acne scarring, re-texturizing of the skin, and hyperpigmentation for all skin~     types . Currently there are very few studies evaluating the safety and efficacy of~     microneedling and chemical peels in skin types III-VI.~      The aim of this study is to evaluate the effects of the combination of microneedling and~     chemical peel for the treatment of acne scars in skin types III-VI.~   "
106424|NCT02174380|"~     The purpose of this study is to determine the effectiveness and cost-effectiveness of a new~     population-based active case-finding program among adult household contacts of new infectious~     TB cases to detect active TB cases in the largest district, Lima, Peru.~   "
106425|NCT02174367|"~     • Main objectives and outcome measures.~        1. Establish prevalence of and factors contributing to fatty liver disease and liver~          fibrosis in patients with psoriasis.~           Fatty liver disease diagnosed via ultrasound. Liver fibrosis diagnosed by liver biopsy~          or non-invasive tests of fibrosis including transient elastography, ultrasound, serum~          markers of fibrosis including procollagen-3-N-terminal peptide (P3NP).~        2. Evaluate non-invasive markers of liver fibrosis in the psoriasis population. Namely~          transient elastography, standard liver function tests and P3NP.~        3. Evaluate the impact of psoriasis disease severity and comorbidities including metabolic~          syndrome on response to treatment in patients with psoriasis.~      Data on co-morbid disease collected through questionnaires and review of medical records.~     Response to treatment assessed using psoriasis area and severity index (PASI) physician~     global assessment (PGA) and dermatology life quality index (DLQI).~        -  Study population: 380 patients with moderate to severe psoriasis will be prospectively~          recruited to the study.~        -  Chief investigator: Professor Jonathan Barker. Co-investigator: Professor Catherine~          Smith~        -  Sponsor/funding organization: Pfizer and Biomedical Research Centre (BRC) at Guys and St~          Thomas Hospitals Trust~   "
106426|NCT02174354|"~     Methotrexate (MTX) is widely prescribed to treat inflammatory conditions including psoriasis,~     where it is the recommended first-line systemic therapy in moderate-to-severe disease.~     Approximately 40% of patients with psoriasis have a sub-optimal response to MTX and a~     significant number experience side effects that may include deranged liver enzymes. There is~     currently no validated test to predict how patients with psoriasis will respond to MTX, in~     terms of disease outcome and/or toxicity, or to guide dose escalation in this group.~   "
106427|NCT02174341|"~     This test is to be collected during the dengue outbreak samples, including samples back in~     the past and forward to close the case, investigating the prevalence of serum Chikungunya~     virus infection, and against those suspected dengue fever, Chikungunya disease-related tests~     conducted to clarify dengue and Chikungunya disease of clinical judgment, rapid method to~     detect Chikungunya virus and then develop.~   "
106428|NCT02174328|"~     The main objective of this trial is to study the occurrence of preeclampsia in recipients of~     donated oocytes receiving aspirin at an early stage during pregnancy and to compare the~     results with those obtained in patients receiving placebo.~   "
106429|NCT02174315|"~     This study examines the impact of a culturally tailored version of contingency management~     treatment on alcohol in 400 alcohol dependent American Indians and Alaskan Natives.~     Participants will be recruited from addiction treatment agencies and throughout the~     community. Those who complete a 4 week induction period will be randomized to receive 12~     weeks of contingency management or a non-contingent control condition. Individuals will then~     be followed for an additional 3-months to assess the long term efficacy of the treatment.~   "
106430|NCT02174302|"~     Comparison of Images of the same area in the bladder in four different SPIES modalities on a~     tablet computer. Participants are asked to delineate the area on the image suspect for~     malignancy as precise as possible with a stylus on the tablet screen. Delineated area(s)~     is/are captured. Time to start the drawing and total time per image are captured. Hereafter,~     an judgement of Image quality is asked on a scale of 0 to 10, 0 being worst possible and 10~     being best possible.~   "
106431|NCT02174289|"~     Cardiac resynchronisation therapy (CRT) is an established treatment for severe systolic heart~     failure with well documented benefits in symptom improvement and reduction of morbidity and~     mortality. However, upto 30% of patients do not respond to treatment despite fulfilling the~     recommended indications. Lack of clinical response may be the result of imperfect left~     ventricular lead placement in the veins around the heart with conventional techniques.~     Optimum lead placement may constrained by coronary venous anatomy and may overlie scarred~     heart muscle or may not be at the site of latest electrical depolarisation. In a further 10%~     of patients, conventional left ventricular lead placement is not possible for other technical~     reasons.~      Left ventricular endocardial lead placement may overcome the limitations and allow placement~     to be guided by echocardiography, electrical mapping and the pattern of heart muscle~     scarring.~      We aim to investigate if targeted left ventricular endocardial lead placement improves~     exercise capacity, heart failure symptoms, heart function and size, heart pumping efficiency~     and biochemical markers of heart strain. Each parameter will be assessed independently and as~     part of a composite cardiac performance score.~      Patients with heart failure will be enrolled who require an endocardial left ventricular lead~     on clinical grounds as either conventional left ventricular lead implantation has technically~     failed or they have clinically non-responded to CRT.~   "
106432|NCT02174276|"~     This study is to evaluate the safety, tolerability, and efficacy of GS-4774 in adults with~     chronic hepatitis B infection (CHB) and who are currently not on treatment. Participants will~     be randomized to receive tenofovir disoproxil fumarate (TDF) alone or GS-4774 plus TDF for 20~     weeks. After Week 20, GS-4774 will be discontinued. All participants will continue on TDF and~     will be followed for an additional 28 weeks. Following completion of the 48 week study~     period, all participants will be eligible for a 3 year registry study.~   "
106433|NCT02174263|"~     This phase II trial studies how well tocilizumab works in treating chronic graft-versus-host~     disease (GVHD) in patients that have not responded to treatment after at least two prior~     therapies. Tocilizumab blocks a protein that stimulates the body's immune system. By blocking~     this protein, the investigators may reduce the symptoms of chronic GVHD.~   "
106434|NCT02174250|"~     The purpose of this study is to test whether Rifampin affects blood levels of istradefylline~     in humans. Rifampin could possibly decrease istradefylline levels.~   "
106435|NCT02174237|"~     The purpose of this study is to determine the safety, tolerability, pharmacokinetics, and~     pharmacodynamics of single and multiple ascending oral dose LNP1892 in healthy males and~     female subjects~   "
106436|NCT02174224|"~     The purpose of this study is to determine if a hospital-based violence intervention programs~     can make sustainable behavior changes in at-risk youth using two key components, brief~     intervention at the hospital bedside and case management.~   "
106437|NCT02174211|"~     To study the effect of pars plana vitrectomy and posterior vitreous detachment on the~     intravitreal pharmacokinetics of ranibizumab~   "
106438|NCT02174198|"~     This study compares two ways of placing a dental implant on the day of tooth extraction. One~     method will place a additional bone graft (derived from bovine bone) and the other group will~     not have the graft placed. Both groups will be restored at the same time with an immediate~     crown.~      The investigators will be researching and comparing the changes in gum level that occur after~     each surgical method, as well as changes in jaw width where the implant is placed.~      The investigators will enroll 16 patients per group. The patients will be followed for 3, 6,~     and 12 months post-immediate implant placement to observe healing.~   "
106439|NCT02174185|"~     The aim of this study is to compare the health-related quality of life (HRQoL) between~     patients underwent conduit diversion and orthotopic neobladder after radical cystectomy. The~     investigators plan to use validated HRQoL questionnaires to learn about how the different~     urinary diversion operations affect the HRQoL of people living with bladder cancer. The~     findings from this study may help doctors and patients choosing the proper operation type.~   "
106440|NCT02174172|"~     This global, multicenter, open-label study will evaluate the safety and tolerability of~     atezolizumab in combination with other immune-modulating therapies in the treatment of~     selected advanced or metastatic malignancies. The atezolizumab plus ipilimumab arm (Arm A)~     will focus primarily on participants with advanced or metastatic non-small cell lung cancer~     (NSCLC). The atezolizumab plus interferon alfa-2b arm (Arm B), plus pegylated interferon~     alfa-2a (PEG−interferon alfa-2a, Arm C), and atezolizumab plus PEG-interferon Alfa-2a plus~     bevacizumab (Arm D) will enroll participants with advanced or metastatic renal cell carcinoma~     (RCC), metastatic NSCLC and melanoma. The atezolizumab plus obinutuzumab) (Arm E) will enroll~     participants with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma~     (HNSCC). Atezolizumab will be administered as intravenous (IV) infusion every 3 weeks (q3w).~   "
106441|NCT02174159|"~     The study will evaluate the safety, tolerability, pharmacokinetics, and antiretroviral~     activity of a single dose of MK-8507 in antiretroviral therapy (ART)-naive, HIV-1 infected~     participants. The hypothesis tested in the study is that at a safe and well-tolerated dose,~     MK-8507 has superior antiretroviral activity to a historical placebo control, as measured by~     change from baseline in plasma HIV-1 ribonucleic acid (RNA) at 168 hours postdose.~   "
106442|NCT02174146|"~     1. Are adipokines involved in pathogenesis of periodontal disease in diabetic patients?~        2. Does their level change after periodontal therapy?~   "
106443|NCT02174133|"~     End stage heart failure is characterized by a critical inability of the heart to meet the~     organism's blood demand even under resting conditions. Heart transplantation (HTx) is the~     established therapeutic approach in the treatment of end stage heart failure and still the~     gold standard treatment. Left ventricular assist devices (LVADs) are considered as a vital~     therapeutic option to temporarily or permanently assist the failing circulation. The~     hemodynamic vascular consequences of implanting LVADs have not been studied in detail. The~     aim of the study is to investigate the effect of LVAD implantation compared to heart~     transplant (HTx) on micro- and macrovascular function in patients with end stage heart~     failure.~   "
106444|NCT02174120|"~     To explore the application of target controlled infusion of etomidate combined with propofol~     in the maintenance of anesthesia during brain surgeries.~   "
106445|NCT02174107|"~     The purpose of this study is to evaluate cost-utility analysis in order to provide~     recommendations to French decision-makers between vertebroplasty and radiation therapy in~     Bone spine metastases. Indeed, radiation therapy is often advocated a systematic way. The~     object of this study would be to expand the use of vertebroplasty.~      Moreover, this study assess to the strategy impact on the pain control reduction and~     functional preservation. In fact, analgesic effect is achieved differently depending on the~     procedure used.Eligible patients will be recruited and registered consecutively. Patients~     will be randomly,~      This is a health-economic multicenter, prospective, randomized with stratification according~     to number of vertebrae to treat (1-3 vertebrae vs 4-6 vertebrae) and center :~        -  Arm A: Percutaneous vertebroplasty~        -  Arm B: External radiotherapy~      This is an open-label study. The expected total study period is 2.5 years (enrolment: 2~     years, patient follow-up: 6 months). A total number of 304 patients with spine metastases~     will be recruited (152 patients/arm).~   "
106446|NCT02174094|"~     The purpose of this study is to investigate the effect on the frequency of tonic-clonic and~     clonic seizures of clobazam as adjunctive therapy compared to placebo after 16 weeks of~     treatment in paediatric patients aged ≥1 to ≤16 years with Dravet Syndrome.~   "
106447|NCT02174081|"~     ARDS is a severe disease, it's important to predict the incidence of ARDS.~   "
106576|NCT02172404|"~     Trial to compare the administration technique for HandiHaler® vs. MDI, to compare the~     learning retention of the administration technique for the HandiHaler® vs. MDI and to compare~     the ease of use for HandiHaler® vs. MDI~   "
106448|NCT02174068|"~     Pain remains the leading cause of consultation. Despite a wide therapeutic arsenal, a~     significant percentage of patients disclaim little or no pain relief with common analgesics,~     specific or not their type of pain. This is especially true in cases of chronic pain, and~     current treatments are associated with many side effects. A need for therapeutic innovation~     is needed. Paracetamol is currently the most widely used analgesic worldwide but despite its~     excellent safety, its analgesic effect is limited from moderate to severe pain. Many~     analgesic drug combinations include paracetamol, recently the co-administration of~     paracetamol and nefopam showed a supra-additive antinociceptive effect (Van Elstraete AC et~     al. 2013). The development of a formulation associating paracetamol and nefopam first~     requires searching a possible pharmacokinetic interaction between the two active substances~     and assessing safety of this combination in healthy volunteers. No published studies~     providing such information.~   "
106449|NCT02174055|"~     The purpose of this study is to develop an accurate and useful way of measuring older~     patients' moods and reactions to the combined issue of cancer treatment and aging.~   "
106450|NCT02174042|"~     The aim of this retrospective study is to review and describe safety and efficacy of Tang~     Ning Tong Luo capsule.~   "
106451|NCT02174029|"~     When a person is put on a breathing machine the investigators think that the breathing~     muscles can get weaker. The investigators are not sure how quickly this happens but in some~     people this leads to problems when they try to breathe on their own without the breathing~     machine. The diaphragm is at the bottom of a person's chest separating their lungs from what~     is in their belly and it is a very strong muscle. In fact, it is main muscle that one uses~     for breathing.~      An ultrasound machine is a painless way to see what is happening beneath the skin. It is safe~     and easy to do. Using an ultrasound the investigators are planning to measure how thick the~     diaphragm is and how much it changes while a person is on a breathing machine in the ICU.~      Getting a better understanding of this condition could lead to improved treatments that might~     help support patients who require a ventilator for breathing.~      The investigators hypothesis is that patients for whom the breathing machine is doing all of~     the work of breathing, will have their diaphragm thickness gradually decrease and changing to~     a breathing modem mode where they have to put in more effort the diaphragm thickness will~     start increasing again.~   "
106452|NCT02174016|"~     This is a prospective pilot study evaluating the safety and feasibility of implementing the~     ketogenic diet in children admitted to the pediatric intensive care unit with acute brain~     injury such as stroke, traumatic brain injury, and intracerebral hemorrhage. Animal studies~     suggest that in the aftermath of injury the brain's ability to use glucose as a fuel is~     impaired. The ketogenic diet is a high fat, low carbohydrate diet which is already used in~     clinical practice for the treatment of medication resistant epilepsy and is intended to~     switch the body over to burning fat rather than carbohydrates for fuel. In lieu of their~     standard tube-feeds, 5-10 children admitted to the PICU with these diagnoses will receive low~     carbohydrate, high fat ketogenic feeds for 2 weeks. We hypothesize that ketones will be~     detectable through serum tests and MRI spectroscopy studies of the brain within several days~     of diet initiation, and that there will be a low incidence of side effects and adverse~     events,~      Measures of interest will include the incidence of kidney stones, excessive acidosis and~     excessive hypoglycemia. The feasibility of implementing this protocol for a larger efficacy~     trial will be assessed through serial measurements of blood glucose, beta-hydroxybutyrate (a~     type of ketone body), and serum bicarbonate levels. In addition, levels of ketone bodies~     within the brain will be measured through MRI spectroscopy sequence which will be acquired at~     the same time as a follow-up MRI brain study ordered for clinical purposes.~   "
106453|NCT02174003|"~     This protocol will allow for the implementation of a research registry pertaining to Whole~     Body Hyperthermia (WBH) use in various subject populations. The primary objective of the~     proposed study is to determine if WBH can have beneficial effects in various subject~     populations currently experiencing numerous other comorbidities, and the duration of the~     effect(s).~      This protocol is intended to become a secondary resort for individual's interested in~     receiving a Hyperthermia treatment for potential beneficial gain related to symptoms stemming~     from comorbidities other than depression (i.e. Fibromyalgia, Perimenopausal symptoms,~     arthritis, etc). Due to the fact that no external research funding has been acquired for this~     broad application this protocol is intended to charge a fee for cost covering purposes only.~      The registry trial will not be limited to only include individuals with major depressive~     disorder, however, this protocol will allow for an expanded use in all populations (while~     still excluding subjects based on safety parameters). We will monitor subject's physiological~     and clinical outcomes (if applicable) from a single Whole Body Hyperthermia treatment in an~     open fashion (no placebo/control condition). This registry study will include safety~     assessments 5 days prior to WBH, the day of WBH and 1 week following WBH.~   "
106454|NCT02173990|"~     The PULsAR trial is an international, investigator-initiated, single arm open-label phase II~     study. The aim of this study is to measure the clinical activity of the combination~     FOLFIRI-aflibercept in an homogeneous group of patients with metastatic colorectal cancer,~     and treated with a FOLFIRI-aflibercept regimen as first line treatment.~   "
106455|NCT02173977|"~     The purpose of this study is to evaluate the appropriate controlled ovarian hyperstimulation~     (COH) protocol in good prognosis patients undergoing IVF treatment. The stimulation~     characteristics of cycles which include ultrashort flare GnRH agonist combined with flexible~     multidose GnRH antagonist will be compared to the flexible multidose GnRH antagonist~     protocol.~      The investigators hypothesized that combining the stimulatory effect of GnRH agonists and~     immediate suppression of the GnRH antagonist in a unique protocol may be a valuable new COH~     strategy for IVF patients, resulting in improved ART outcome.~   "
106467|NCT02173821|"~     This is a follow-up study of patients, treated with one daily dose of Zomacton or one daily~     dose of Genotropin in the previously completed FE 999905 CS07 trial, who had presence of~     anti-hGH antibodies at any post-dosing visit during the 12-month treatment period. No~     investigational medicinal product will be administered in connection with this follow-up~     study. Eligible patients will attend one visit in this follow-up study.~   "
106468|NCT02173808|"~     To evaluate the levonorgestrel (LNG) pharmacokinetic (PK) profile following injection of a~     single 20 mg dose of levonorgestrel butanoate (LB).~   "
106456|NCT02173964|"~     1. Background~             1. PET/CT (positron emission tomography/computed tomography) using FDG~               (fluorodeoxyglucose) is widely used for evaluation of cancer patients.~             2. Bowel uptake of FDG is a serious problem that hampers the proper reading of PET/CT.~             3. There is no widely-accepted method to reduce the bowel FDG uptake.~        2. Purpose~             1. To know whether pinverin (pinaverium bromide) application during PET/CT can reduce~               bowel uptake of FDG.~             2. Pinverin is a calcium-channel blocker that ameliorates the bowel contraction.~             3. Pinverin may be useful to reduce bowel FDG uptake by ameliorating the bowel~               contraction during PET/CT acquisition.~        3. Method~             1. Intervention versus control: administration of single tablet of pinverin (50mg)~               perorally versus simple water (~100mL).~             2. Timing of administration: At the time of FDG injection. PET/CT images will be~               acquired 1hr post FDG injection.~        4. Primary outcome~             1. SUV (standardized uptake value) difference between pinverin administered patient~               group versus control group.~             2. SUV (standardized uptake value) is calculated as: (decay corrected radioactivity in~               mCi/mL) x (body weight in g) / (injected radioactivity in mCi)~   "
106457|NCT02173951|"~     A prospective randomized study on Safety, Tolerability and Efficacy of oral Low dose DFP (50~     mg/kg/day) in minimally transfused B-TM after 5 transfusions when SF reaches 500 ng/m and~     with either appearance of LPI > 0.2 or TSAT reaches 50% compared with non treatment arm.~      So the aim of this study:~        1. To determine the time as well as amount of transfused iron ( calculated in mg iron/kg )~          which lead to Serum ferritin reaches 500 ng /ml and LPI appearance >0.2 as well as TSAT~          reaches 50 % .~        2. Tolerability and safety of early low dose DFP 50mg/kg and effectiveness to postpone or~          prevent SF from reaching 1000 ng/ml or LPI >0.6 or TSAT >70% in comparison to patients~          not starting chelation therapy~        3. Determine adverse events whether drug or non drug related~   "
106458|NCT02173938|"~     Our overall research goal is to determine how these novel psychosocial factors impact~     cessation. This pilot study will answer how dual use of other tobacco products, direct to~     consumer marketing, and the new phenomenon of butting-out and relighting influences~     cessation, and how understanding impulsivity and task persistence could lead to new and~     improved behavioral interventions for tobacco dependence. Answers to these pilot questions~     will lead to the publication of several manuscripts and provide important feasibility data to~     design large, well-powered clinical trials, population-level epidemiological studies, and~     contribute to furthering the field of tobacco treatment.~   "
106459|NCT02173925|"~     The pathophysiology of functional dyspepsia is still unclear but several peptides have been~     indicated in the etiological factors in FD. Ghrelin and leptin are involved in regulation of~     appetite and gut motility and serotonin is a typical neurotransmitter related with sensory~     and motor functions of gut. On the other hand, transient receptor potential vanilloid~     receptor 1 (TRPV1) has been proposed to be involved with functional gastrointestinal~     disorder, and expression of this receptor could be regulated by nerve growth factor (NGF) or~     glial cell-line derived neurotrophic factor (GDNF). The investigators aimed to determine~     whether expressions of ghrelin,leptin, serotonin,TRPV1,GDNF and NGF in blood or gastric~     mucosa of FD patients are different from those in healthy controls, and whether some changes~     of their expression correlate with certain dyspeptic symptoms. The investigators also~     investigated the effect of H. pylori infection by comparing their expressions before and one~     year after H. pylori eradication.~   "
106460|NCT02173912|"~     This study is designed to evaluate the bioequivalence of the two treatments, the~     administration of CJ-30059 and the co-administration of candesartan cilexetil and amlodipine~     besylate, in healthy volunteers.~   "
106461|NCT02173899|"~     The purpose of this study is to observe the occurrence of adverse events, seroconversion rate~     and geometric mean titres(GMTs) of 2 doses of live attenuated varicella vaccine.~   "
106462|NCT02173886|"~     This study is being conducted to evaluate how the body absorbs and processes the sustained~     release (SR) and extended release (XL) medication bupropion (Wellbutrin®). Subject who are~     1-3 years post gastric bypass surgery will be invited to participate. Non-surgical controls~     will also be enrolled based on a matching criteria to post gastric bypass subjects.~     Participants will be asked to complete two 12-hour study days approximately 11 days apart.~   "
106463|NCT02173873|"~     Aflibercept is FDA approved and the same molecule is available as hyperosmolar for oncology~     (cost 800 USD for 4ml) and isoosmolar for Ophthalmology (cost 1,770 USD for 0.05ml~     injection). The 4ml bottle can be fractionated to be used in 40 patients hence the 0.05 ml~     injection would cost 20 USD for patients. Animal studies showed the injection is safe,~     knowing that the rabbit vitreous volume is 3-4 times smaller than the human eye. Our pilot~     study is to ascertain if the approved molecule for oncology when injected in the eye is safe~     as it is diluted into 5ml vitreous (100 times dilution). If this is so then we can save the~     patient 100 times for the most efficient antiVEGF that is used for maculopathy in various~     diseases (AMD, DME, CRVO, etc..)~   "
106464|NCT02173860|"~     The purpose of this study is to determine whether, in patients undergoing elective valvular~     heart surgery, revascularization of concomitant coronary artery disease (CAD) guided by FFR~     (Fractional flow reserve) would be superior to standard angiography-guided-revascularization~     approach on major efficacy and safety outcomes~   "
106465|NCT02173847|"~     Laser- assisted procedures in penetrating keratoplasty (PK) are proposed to improve the~     surgical outcomes: minimally invasive procedures, improved biomechanical stability of the~     transplanted flap, reduction of rejection risks, reduction of inflammation, reduction of~     infections risk, faster healing process.~      In order to achieve these goals, two different lasers were used during PK surgery:~        -  a femtosecond laser to cut an anvil shaped profile~        -  a diode laser to weld the surgical wound~   "
106466|NCT02173834|"~     In this study the investigators aim to investigate whether the sympathetic stimulation of~     BAT, as assessed with a 123I-metaiodobenzylguanidine single-photon emission computed~     tomography computed tomography scan, differs between lean and obese individuals, as an~     explanation for the diminished metabolic brown adipose tissue activity in obese subjects.~      The investigators hypothesis is that sympathetic nervous system activity in the obese is~     diminished as compared to their leaner counterparts as an explanation for the diminished~     metabolic brown adipose tissue activity in the obese.~   "
106469|NCT02173795|"~     The primary objective of this study was to investigate patients acceptability / preference of~     Berodual® Respimat® inhaler as compared to the conventional Berodual® Metered Aerosol (MA)~     inhaler. Ease of handling and assembling the Respimat® inhaler at home under real life~     conditions was also evaluated.~   "
106470|NCT02173782|"~     To demonstrate that at least one of the two doses of Berodual® (50 µg fenoterol~     hydrobromide/20 µg ipratropium bromide and 25 µg fenoterol hydrobromide/10 µg ipratropium~     bromide, 1 puff q.i.d) administered via the Respimat® gives a bronchodilator response which~     is not inferior to that obtained from one dose of Berodual® (50 µg fenoterol hydrobromide/21~     µg ipratropium bromide, 2 puffs q.i.d) administered via the MDI and that the safety profile~     is at least as good when COPD patients are treated for 12 weeks.~   "
106471|NCT02173769|"~     The decrease in physical activity due to increasing dyspnoea that over time leads to a~     steadily worsening condition and increasing restriction of physical functioning is a key~     problem for COPD patients and affects even the early stages.~      Clinical studies to investigate both Spiriva® and Striverdi® Respimat® have demonstrated a~     marked improvement in physical exercise capacity.~      However, there have so far been no data from the daily practice setting about everyday~     functioning on combination treatment with Spiriva® Respimat® plus Striverdi® Respimat® or~     Spiriva® 18 Mikrogramm plus Striverdi® Respimat® in patients requiring treatment with 2~     long-acting bronchodilators.~      The objective of this NIS is to measure changes in physical functioning as a surrogate for~     physical activity and exercise capacity in COPD patients on treatment with Spiriva® Respimat®~     plus Striverdi® Respimat® or Spiriva® 18 Mikrogramm plus Striverdi® Respimat® in routine~     daily treatment (so-called real life setting).~   "
106472|NCT02173756|"~     Chemotherapy kills tumor cells but can also damage healthy cells and cause significant~     digestive disorders such as ulcers of the mouth, called mucositis. Mucositis are transient~     but their intensity may require special measures. Mucositis are painful and morphine gel or~     intravenous morphine is used to relieve pain.~      However, the pain of oral mucositis induced by chemotherapy is not completely relieved by~     morphine administered intravenously.~      As part of the study, the investigators want to evaluate an oral gel containing a small~     amount of morphine so that it acts directly on the mucositis. The investigators believe that~     the direct action of morphine on mucositis may be more effective on pain.~   "
106473|NCT02173743|"~     Needle aspiration of calcific deposits (NACD ) is the treatment of choice for calcific~     tendinitis which does not respond to conservative treatment. NACD is effective in~     approximately 70% of the patients.When NACD is not effective, surgery is often the only~     treatment that remains.Surgery, however, is discouraged by th e Dutch guidelines for~     diagnosing and treating patients with subacromial pain syndrome.Therefore,both patients and~     the doctors treating those patients will benefit from a more effective minimal invasive~     treatment for calcific tendinitis.Injection of platelet-rich plasma (PRP) might, considering~     its positive effect on tissue repair, be a possible solution here.Previous research~     investigating the effects of PRP on other tendinopathies did, however, show controversial~     results. The aim of this double-blind randomized controlled trial is to investigate the~     effect of the adjuvant application of PRP after NACD on pain reduction ,recovery of shoulder~     function, tendon recovery,resorption of calcific deposits, the percentage of patients with~     persistent complaints and quality of life.~   "
106474|NCT02173730|"~     To assess the steady state pharmacokinetic profile of BIBR 953 ZW after administration of~     BIBR 1048 to male and female elderly subjects, to assess pharmacokinetic gender differences.~     To assess the effect of coadministration of Pantoprazole on the bioavailability of BIBR 953~     ZW.~   "
106475|NCT02173717|"~     Study to investigate whether and to what extent the suggested P-glycoprotein (P-gp) inducer~     rifampicin affects plasma exposure of dabigatran.~   "
106476|NCT02173704|"~     Assess the safety and immunogenicity of a 3-dose schedule (at 2, 4, 6 months) of Novartis~     Meningococcal B recombinant vaccine followed by a booster at 12 months when concomitantly~     administered with routine vaccines in healthy infants in Taiwan.~   "
106477|NCT02173691|"~     The objective of this study is to compare the long-term (six month) bronchodilator efficacy~     and safety of tiotropium inhalation capsules, salmeterol inhalation aerosol and placebo~     inpatients with COPD.~   "
106478|NCT02173678|"~     Study to assess the safety and tolerability of COMBIVENT® hydrofluoroalkane (HFA) as compared~     to COMBIVENT® chlorofluorocarbons (CFC) and placebo HFA after single and repetitive dosing in~     healthy male and female subjects~   "
106479|NCT02173665|"~     The objective of the current study was to investigate safety, tolerability, pharmacokinetics~     and pharmacodynamics of BI 1356 BS.~   "
106480|NCT02173652|"~     The objective was to investigate the influence of 2 different dosage regimens (5 mg once~     daily vs. 2.5 mg twice daily) on the steady-state pharmacokinetics and pharmacodynamics of~     orally administered BI 1356.~   "
106481|NCT02173639|"~     The objective was to assess the relative bioavailability of a pilot scale linagliptin 2.5 mg~     / metformin 1000 mg fixed dose combination (FDC) tablet in comparison with single tablets of~     linagliptin 2.5 mg and metformin 1000 mg administered together.~   "
106482|NCT02173626|"~     An eight week mindfulness training for physicians in a community hospital setting, largely~     administered through web-casts, will decrease stress and burnout, increase job satisfaction,~     and develop lasting mindfulness skills in the participants.~   "
106483|NCT02173613|"~     The main objective is to evaluate the interest of the repeated measurement of procalcitonin~     in patients with pulmonary infection to reduce the duration of antibiotic therapy in~     comparison with a conventional clinical strategy.~   "
106484|NCT02173600|"~     The Intensive Dietary Counselling (IDC) intervention is a prevention and health promotion~     activity. It is being implemented by the Andalusian Health Service to reinforce basic~     intervention advice on healthy diet and exercise. The IDC intervention is aimed at the~     prevention of diseases of the heart and blood vessels (e.g. heart failure, heart attack and~     stroke).~      The main objective of the present study is to assess adherence to the IDC intervention and,~     consequently, its effectiveness on the prevention of the above mentioned diseases.~   "
106498|NCT02173418|"~     The purpose of this study was to test whether peroperative infiltration of the phrenic nerve~     during lung surgery would protect patients against postoperative shoulder pain.~   "
106485|NCT02173587|"~     Previous study found that lipid extract from hard-shelled mussel (HMLE) at a dose of 100mg/kg~     possessed strong anti-inflammatory activity by diminishing the hind paw swelling and~     arthritis index in rat model. In the present study, HMLE was processed to capsules under~     strict food safety supervision and patients with active rheumatoid arthritis (RA）were~     selected to examine whether supplementation with HMLE could improve clinical and laboratory~     parameters of disease activity. The validated disease activity score that include 28 joint~     counts and ESR (DAS28) and validated clinical disease activity index (CDAI) were primary~     outcome measure. Laboratory parameters including IL-1β, IL-6, IL-10, TNF-α,PGE2 and COX-2~     were also measured to explore the mechanisms.~   "
106486|NCT02173574|"~     The purpose of Part 1 is to inform dose selection for use of alisporivir and EDP239 in~     combination and obtain initial safety data for co-administration of alisporivir and EDP239 to~     support future treatment studies in patients. The purpose of Part 2 is to inform the~     drug-drug interaction potential of EDP239 more broadly and possibly facilitate the~     interpretation of lower than expected alisporivir concentrations in Part 1, if observed.~   "
106487|NCT02173561|"~     The purpose of this study is to conduct a randomized controlled trial to compare group and~     individual CPT-C for the treatment of PTSD in OIF/OEF military personnel.~   "
106488|NCT02173548|"~     -  Heart Failure with Preserved Ejection Fraction (HFpEF) is a common form of heart failure~        -  Standard treatment for heart failure, show less than ideal results in HFpEF~        -  Evidence of systemic inflammation is common in all forms of heart failure, including~          HFpEF~        -  The main hypothesis of this study is that systemic inflammation contributes to heart~          failure symptoms and exercise limitations in patients with HFpEF~        -  The main objective is to treat patients with HFpEF and evidence of systemic inflammation~          with an anti-inflammatory drug targeting Interleukin-1 (or placebo) to determine effects~          on cardiovascular function~   "
106489|NCT02173535|"~     The study is designed to test five new soft contact lens color pattern variants to determine~     whether the test lens makes the wearers eyes look bigger, more defined or enhances their~     overall appearance.~   "
106490|NCT02173522|"~     The purpose of this study is to determine whether pre-operative prostate artery embolization~     (PAE) reduces intra-operative blood loss and improves surgical outcomes among prostate cancer~     patients undergoing robot-assisted laparoscopic radical prostatectomy (RALRP).~   "
106491|NCT02173509|"~     This is a cluster randomised controlled trial covering all general practitioners working in~     the National Health System (SNS) and all pharmacists working in community pharmacies in the~     area covered by the Health Region Administration of Center (ARS-C) . A specific educative~     intervention, designed from gaps detected in knowledge and attitudes with respect to~     antibiotics and resistance, will be carried out on the intervention group. The control group~     will not receive any specific intervention.~      Hypotheses:~        1. The attitudes and knowledge towards antibiotics generate habits of prescription by~          physicians~        2. The attitudes and knowledge towards to antibiotics generate propensity to dispense~          antibiotics without prescription by pharmacists~        3. The identification of the attitudes, knowledge and factors that generate habits of~          inadequate prescription will allow the design of specific educative interventions to~          improve the use of antibiotics~        4. The identification of the attitudes, knowledge and factors that generate propensity to~          dispense antibiotics without prescription will allow the design of specific educative~          interventions to antibiotic use~        5. The interventions designed from gaps detected in knowledge and attitudes with respect to~          antibiotics and resistance will improve the prescription and dispensation of antibiotics~          by physicians and pharmacists, respectively.~        6. The intervention will collaborate in the control of the bacterial resistance.~   "
106492|NCT02173496|"~     Neovascular or wet age-related macular degeneration (ARMD) is a retinal disease and is the~     leading cause of sight loss in the over 50s; it constitutes a major public health problem~     which will have an increasingly large impact as the population ages, because sight loss has~     been associated with loss of independence, depression, social isolation, and falls.~      Recent advances in medicine, and in particular the approval on behalf of the National~     Institute for Health and Clinical Excellence (NICE) for use of ranibizumab (Lucentis) in wet~     ARMD, have allowed this condition to be treated; however success is more likely when~     treatments occur at a very early stage.~      Unfortunately the early stages of wet ARMD do not cause symptoms and most cases are diagnosed~     when irreversible retinal damage has already occurred.~      In all stages of ARMD, even when no symptoms are present and non-invasive techniques~     currently used in routine clinical practice are not sufficiently sensitive to identify~     abnormalities, retinal function and possibly anatomy are abnormal.~      This study will evaluate techniques that may be useful in flagging subjects with the~     preclinical stages of the disease. This may allow early preventative measures to be taken,~     in order to stop altogether the onset of blindness.~      The study will focus mainly on colour contrast sensitivity, a simple but highly sensitive~     technique to assess retinal function, to establish if people with wet ARMD can be identified~     before symptoms develop. Other assessment modalities, evaluating either structure or function~     of the retina, will also be employed in selected individuals to establish if they may be used~     in the routine clinic; however it is already known that these modalities are not suitable for~     all individuals, as they are more demanding time-wise and concentration-wise, and therefore~     not universally suitable.~   "
106493|NCT02173483|"~     The purpose of this study is to determine whether there is a difference in muscle strength~     after anterior cruciate ligament comparing 2 surgery technics. Using either autograft~     hamstrings tendon or a autograft quadriceps tendon.~   "
106494|NCT02173470|"~     To assess if information about aortic calcification obtained from routine preoperative ultra~     low-dose chest CT lowers the postoperative stroke rate in patients undergoing heart surgery~     by optimizing surgical strategy compared to the normal work-up with a conventional chest~     X-ray.~   "
106495|NCT02173457|"~     The purpose of this study is to evaluate the efficacy and safety of Chiglitazar, compare with~     Sitagliptin.~   "
106496|NCT02173444|"~     Serum bio-markers have different prediction values for ovarian response during ovarian~     stimulation in-vitro fertilization~   "
106497|NCT02173431|"~     Prolonged external pressure to the tissue leads to compression, ischemia and development of~     pressure ulcer.~      Underweight seems to be associated with high pressure ulcer risk but the distinct relation~     between overweight and pressure ulcer development is uncertain.~      Bedsores are caused by pressure against the skin that limits blood flow to the skin and~     nearby tissue.~      Others factors related to limited mobility can make the skin vulnerable to damage and~     contribute to the development of pressure sores. Three primary contributing factors are~     sustained pressure, friction and shear.~      Bedsores are easier to prevent than to treat.~   "
106499|NCT02173405|"~     This research study because is looking at woman with symptoms of chronic pelvic pain caused~     by short, tight, and tender pelvic floor muscles (Myofascial Pelvic Pain syndrome). The~     purpose of this study is to determine whether or not injections with onabotulinumtoxinA~     (Botox) improve symptoms of pain and tenderness. The drug being studied, Botox is FDA~     approved for other uses. However, Botox is not FDA approved for the use in myofascial pelvic~     pain (MPP). Therefore, Botox is considered experimental or research in this study.~   "
106500|NCT02173392|"~     A healthy subject, 2-way cross-over study to evaluate the bioequivalence of a single dose of~     Brodalumab vs. two doses of Brodalumab~   "
106501|NCT02173379|"~     ABSORB IV is a prospective, randomized (1:1, Absorb BVS to XIENCE), single-blind,~     multi-center study, registering approximately 2610 subjects from approximately 140 sites in~     the United States and outside the United States. ABSORB IV is a continuation of ABSORB III~     (NCT01751906) trial which are maintained under one protocol because both trial designs are~     related. The data from ABSORB III and ABSORB IV will be pooled to support the ABSORB IV~     primary endpoint. Both the trials will evaluate the safety and effectiveness of Absorb BVS.~      The ABSORB IV Randomized Controlled Trial (RCT) is designed to continue to evaluate the~     safety and effectiveness as well as the potential short and long-term benefits of Abbott~     Vascular Absorb™ Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System~     (once commercially available), as compared to the commercially approved, control stent~     XIENCE.~   "
106502|NCT02173366|"~     African American women have among the highest rates of overweight and obesity and few meet~     dietary or physical activity guidelines. The investigators seek to develop a new intervention~     strategy that will help alleviate health disparities, thereby improving quality of life,~     health care costs, and disease burden. The African American Collaborative Obesity Research~     Network (AACORN) recommends an eco-social, community-engaged approach to behavior change that~     is in line with cultural values of interconnectedness and care for others. The purpose of~     this study is to operationalize the AACORN paradigm to promote improvements in weight status~     and health through a civic engagement approach. To achieve this, participants will meet in~     church-based Change Clubs and be led through a 6 month curriculum, which includes both~     lessons in cardiovascular risk reduction and a civic engagement project. Civic engagement may~     lead to change in individual health behaviors by increasing self-regulation and~     self-efficacy. The investigators will measure club members' adherence to the Change Club~     intervention, defined as average number of sessions attended, retention in the clubs,~     satisfaction with the Change Club experience and achievement of at least 50% of~     self-identified benchmarks for community change within 6 months. In addition the~     investigators will compare anthropometric factors, diet and physical activity behaviors,~     blood pressure, cardiorespiratory fitness, and psychosocial factors before and after~     participation in the Change Club intervention.~   "
106503|NCT02173353|"~     The purpose of this study is to evaluate the effectiveness of using ultrasound to image and~     track pancreas/duodenum motion during radiation therapy treatment delivery. Also develop a~     workflow and process to allow the final ultrasound system to be used routinely by radiation~     therapists.~   "
106504|NCT02173340|"~     Sedation during spinal anesthesia is very useful for patients' comfort. However, intermittent~     bolus of sedative frequently results in inappropriate sedation which comes with various side~     effects such as patients' discomfort and apnea. Therefore, it would be reasonable to use~     target-controlled infusion(TCI) to provide proper sedation without serious side effects.~      In this study, the investigators try to find the appropriate propofol target concentration~     with TCI device and build a pharmacodynamic non-linear mixed effect model between propofol~     target concentration and side effects.~   "
106505|NCT02173327|"~     Postoperative pulmonal complications (Abbreviation - PPC) after major abdominal surgery~     remains a significant clinical problem delaying rehabilitation after surgery. CPAP is one~     approach to minimize the frequency and severeness of PPC.~      In the investigators' organization intermittent mask CPAP every 2 hour, 15min, is used~     routineously after major abdominal surgery.~      Recently new devices has been designed, which give the opportunity tip deliver continuously~     CPAP with out interruptions because of presumed better comfort. Therefore better patient~     compliance.~      No studies to date have investigated the possible benefit of using continuously helm CPAP~     versus the traditional intermittent mask CPAP after major abdominal surgery.~      The investigators' study will investigate if there are any benefits with continuously Helm~     CPAP Versus intermittent Mask CPAP After Major Abdominal Surgery.~   "
106506|NCT02173314|"~     The evaluation of the Nevada Initiative to Reduce Long-Term Foster Care (LTFC) includes three~     populations. It will examine how the interventions SAFE- FC and FSE impact or relate to~     permanency outcomes for children most at risk for long term foster care and currently in~     care.~   "
106507|NCT02173301|"~     The purpose of the study are:~        1. To evaluate the efficacy of 3 doses of XP23829 compared to placebo for the treatment of~          moderate-to-severe chronic plaque-type psoriasis.~        2. To evaluate the safety and tolerability of XP23829 in subjects with psoriasis.~        3. To evaluate the pharmacodynamics (PD) of XP23829 through immunological analysis of~          peripheral blood samples.~   "
106508|NCT02173288|"~     The development of ascites in the natural history of cirrhosis heralds a worsening of the~     prognosis to 50% survival at 2 years, and this deteriorates to 30-50% at 1 year when the~     ascites becomes refractory to medical therapy. Hemodynamic alterations and their relation to~     neurohumoral systems are essential in pathophysiology of ascites formation. The theory that~     best explain the ascites formation and sodium retention in cirrhotics is portal hypertension~     leading to splanchnic arterial vasodilatation leading to underfilling of arterial circulation~     which is sensed by the arterial and the cardiopulmonary receptors leading to sympathetic~     nervous system activation and activation of the anti-natriuretic factors (RAAS and arginine~     vasopressin), resulting in sodium and water retention. The therapeutic options available for~     patients with refractory ascites are serial therapeutic paracentesis, liver transplantation~     and transjugular intrahepatic portosystemic shunts.Vasopressin V2 receptor antagonists~     antagonize the antidiuretic effects of vasopressin at the V2 receptor located in the renal~     collecting duct, they increase free water clearance, and thus may be helpful in mobilizing~     excess water in conditions associated with water retention including cirrhosis. The use of V2~     receptor antagonists in cirrhosis with ascites has been shown to be safe and efficacious.~     Midodrine, an alpha adreno receptor agonist by causing splanchnic vasoconstriction has been~     used in hepatorenal syndrome (HRS) and for control of ascites in patients with refractory or~     recurrent ascites. It is possible that vasoconstrictors and aquaretics (V2 receptor~     antagonists) by acting at different sites in combination may reverse some of the pathogenic~     events that results in refractory or recurrent ascites.There are no reports on the use of~     combination of midodrine and tolvaptan in the patients with cirrhosis with ascites.~     Therefore, we plan to study the role of midodrine, tolvaptan and their combination on~     systemic hemodynamics, renal functions and control of ascites in patients with cirrhosis and~     refractory or recurrent ascites.~   "
106577|NCT02172391|"~     Trial to investigate the acute and chronic effect of tiotropium therapy on airway diameter in~     COPD patients as measured by inspiratory capacity (IC).~   "
106509|NCT02173275|"~     The study seeks to determine the accuracy of using anatomic and physiologic information~     measurable by computed tomography features of stenosis, plaque, fractional flow reserve-CT~     and to compare this measure to stress testing for the detection of myocardial ischemia~     against the gold standard of cardiac catheterization with fractional flow reserve. The~     hypothesis of this proposal is that integrating anatomic plaque features with physiologic~     fractional flow reserve-CT will optimize identification of coronary lesions that are~     ischemia-causing by computed tomography .~   "
106510|NCT02173262|"~     The Integrated Consent Model is being increasingly used internationally to improve patient~     care. In this feasibility study we will explore whether the model is feasible in practice;~     and whether it can be used to increase the number of physicians and patients who take part in~     clinical trials, and address the critical issue around the optimal febrile neutropenia~     prevention by randomizing eligible patients to either G-CSF or ciprofloxacin.~   "
106511|NCT02173249|"~     The purpose of this study is to evaluate the Plasma Pharmacokinetics and Safety of AC 170~     0.24% in Healthy, Adult Subjects when used twice daily for one week.~   "
106512|NCT02173236|"~     The impact of platform switching with flapless surgery on early-loaded single-tooth implants~     on esthetic outcomes.~   "
106513|NCT02173223|"~     A. To evaluate the ocular hypotensive efficacy of the rho-kinase Inhibitor (AR-12286 0.5% and~     0.7%) ophthalmic solutions in glaucoma patients with failed prior glaucoma filtering surgery~     and uncontrolled IOP who are facing further surgical intervention. Patients will be treated~     for 6 months in this initial trial.~      B. To evaluate the efficacy of AR-12286 in enabling treated patients to delay or avoid the~     necessity of further surgical intervention.~   "
106514|NCT02173210|"~     This project is examining genetic and metabolic markers for the use of 17 hydroxyprogesterone~     caproate (17OHPC) in pregnant women with a history of preterm birth (PTB). 17OHPC has been~     associated with a 30-35% reduction in repeat PTB in women carrying a singleton gestation.~     However, it is not well known why it works for some women but not for others. There are~     limited available interventions for the prevention of recurrent PTB. This study will enroll~     150 women at risk for PTB and eligible to receive 17OHPC, and expect that 80% will use 17OHPC~     and 20% will decline use. We will obtain blood samples and samples of cervical cells and~     cervical vaginal fluid. The objective of the study is to identify genetic, microbial and~     molecular markers that help to identify which women at risk for recurrent preterm birth will~     respond to 17OHPC and which women will not. The ultimate goal is to develop a personalized~     screening test based on these markers.~   "
106515|NCT02173197|"~     To date, there are no studies that demonstrate that the intervention of Occupational Therapy~     (OT) in patients considered to be complex, regardless of diagnosis, could improve clinical~     and functional outcome for the patient.~      For this reason, we intend to undertake a study that will allow us to deepen the knowledge~     about the impact of the OT on in-hospital patients considered complex according to the~     assessment by the Rehabilitation Complexity Scale (RCS ).~      Our hypothesis is that the intervention of OT can improve their care by qualified and focused~     on the needs of the person interventions.~   "
106516|NCT02173184|"~     To investigate the efficacy (therapeutic response) of Gynevac vaccination following a 5-shot~     treatment period in patients with bacterial vaginosis, based on the Nugent Score and the~     Amsel criteria~   "
106517|NCT02173171|"~     A Registry Study to Evaluate the Survival and Long-Term Safety of Subjects Who Previously~     Received Talimogene Laherparepvec in Amgen or BioVEX-Sponsored Clinical Trials~   "
106518|NCT02173158|"~     Study to Evaluate the Efficacy and Safety of Lomitapide in Japanese Patients with Homozygous~     Familial Hypercholesterolemia (HoFH) on Concurrent Lipid-Lowering Therapy.~   "
106519|NCT02173145|"~     Idiopathic pulmonary fibrosis (IPF) is a devastating disease with no cure available. Patients~     suffer from respiratory symptoms including dyspnea and cough. To improve life quality the~     investigators will test the effects of immunomodulation of macrolides specifically on cough~     in IPF patients. The investigators hypothesize that immunomodulatory treatment reduces cough~     frequency and might improve lung function.~   "
106520|NCT02173132|"~     This study evaluated the effects of acetyl-L-carnitine treatment on Perceived Work Stress,~     Work Ability and Work Performance in subjects with Hepatic Encephalopathy.~   "
106521|NCT02173119|"~     Transcatheter arterial chemoembolization (TACE) is a widely accepted palliative therapy for~     the treatment of HCC. Palliative means that it does not cure the disease prolongs your life~     and improves quality of life. During TACE, a mixture of chemotherapy drugs is combined with~     an oil called lipiodol. Lipiodol has a role as both drug carrier and embolic agent (a~     material that blocks blood flow to tumors). The lipiodol/chemotherapy mixture is injected~     into an artery (blood vessel) directly supplying blood to a HCC tumor.~      Lipiodol is made up of fat and water which can be seen on MRI. Therefore, MRI can be used to~     quantify the amount of lipiodol delivered to the HCC tumors.~      In this study, the investigators want to see if patient survival is related to the amount of~     lipiodol delivered to HCC tumors.~   "
106522|NCT02173106|"~     This prospective, randomized, controlled, multicenter clinical trial will evaluate~     Opportunity, Validity and Security of Steroids Plus Cyclosporin therapy for patients of~     Idiopathic Membranous Nephropathy.~   "
106523|NCT02173093|"~     The investigators have found in the previous research that the investigators can coat (arm) T~     cells with a special molecule called GD2 bispecific antibody that will help T cells recognize~     neuroblastoma and osteosarcoma cells and kill them. This bispecific antibody recognizes GD2,~     a protein found on almost all neuroblastoma and osteosarcoma cells. The investigators put the~     GD2 bispecific antibody on T cells and give large numbers of these T cells back to patients.~     The investigators think that these T cells may have a better chance of killing neuroblastoma~     tumor cells when they are armed with GD2 bispecific antibody. This trial studies the side~     effects and best dose of activated T cells armed with GD2 bispecific antibody and how well~     they work in treating patients with neuroblastoma, osteosarcoma, and other GD2-positive solid~     tumors.~   "
106524|NCT02173080|"~     This Pilot study will enable development & assessment of a Polycystic Liver Disease-specific~     patient reported outcomes questionnaire (PLD-Q). Polycystic liver disease (PLD) is~     characterized by the formation of numerous cysts in the liver, and can lead to severe~     symptomatic hepatomegaly. It is common in patients with autosomal dominant polycystic liver~     disease (ADPLD) and autosomal dominant polycystic kidney disease (ADPKD).~   "
106525|NCT02173067|"~     The purpose of this study is to investigate the variation in blood glucose levels,~     hemodynamic effects and patient anxiety score during tooth extraction in type 2 diabetes~     mellitus with coronary disease patient under local anesthesia with lidocaine 2% with and~     without epinephrine.~   "
106526|NCT02173054|"~     Acne is an inflammation of sebaceous glands and follicles. Applying topical treatments such~     as adapalene gel may cause irritant adverse effects. Hence, using a moisturizer is another~     way to protect or relieve this undesirable event. Moisturizers that have anti-inflammatory~     property could reduce irritant effects, emergent from using topical treatment and also reduce~     severity of acne.~      Research teams chose an adapalene gel to act as topical treatment for curing acne. It has~     anti-inflammatory and comedolytic effects and has fewer side effects than other groups of~     topical retinoic acids. However, peeling skin, redness skin, tingling sensation or itching~     sensation may occur if they are continually used for a long period. Thus, for the purpose of~     studying the efficacy of moisturizer containing licochalcone A, L-carnitine and~     1,2-decanediol in reducing irritant effect of using adapalene gel (Licochalcone A has~     anti-inflammatory effect, L-carnitine decrease sebum production and 1,2-decanediol has~     anti-bacterial effect).~   "
106527|NCT02173041|"~     Substance Use Disorder has been showing a rising trend all over the world including India.~     The project tested whether a Integrated community wide effort of Prevention and Awareness~     Groups (PAG) to manage substance use would have a greater effect on treatment attendance and~     drug abstinence than a de-addiction program alone.~   "
106528|NCT02173028|"~     Patients will be treated according to the clinical practice of the participating centers and~     to the international guidelines for the treatment of heart failure.The present analysis~     provides a collection of data about the changes to drug therapy after the Cardiac~     Resynchronization Therapy (CRT) procedure , and any signs and symptoms of intolerance to~     prescribed medications.~   "
106529|NCT02173015|"~     The purpose of this study is to evaluate the effect that a new fall prevention training~     program has on the fall incidence of long-term care facility residents at high-risk of~     falling.~   "
106530|NCT02173002|"~     Inflammatory bowel diseases (IBD) is an invalidating disease mainly diagnosed in young~     people. The disease is characterized by a heterogenic phenotype and the disease course by~     flares and remissions. As in most chronic diseases the economic burden of IBD is important~     due to direct health care costs and disability. Health care reorganization for IBD patients~     in the Netherlands is necessary for several reasons. First chronic (sub)clinical mucosal~     inflammation results in irreversible bowel damage and complications and none of the presently~     available drugs is effective for all patients and many drugs have possible severe side~     effects. To prevent complications of the disease and side effects IBD should be monitored~     carefully. In the Netherlands however there is a shortage of gastroenterologists where the~     incidence of IBD is rising. Secondly evidence exists that direct involvement of health care~     workers, patient empowerment and integrated care can improve the outcome of chronic diseases.~     Thirdly many clinically relevant aspects (e.g. malnutrition) of this complex disease are not~     systematically followed in routine care. Finally the government demands registration of~     efficacy endpoints for expensive drugs in the near future. Therefore the investigators~     developed a web-based Telemedicine tool for IBD patients in collaboration with the Dutch IBD~     patient's organization (CCUVN). myIBcoach contains E-learning modules, monitors disease~     activity, disability, quality of life, adherence, infections, smoking status, side effects,~     stress and malnutrition on fixed time points with validated questionnaires, allows the~     patient to communicate with health care workers and gives feedback to the back office and the~     patient. A feasibility study in 30 IBD patients in 3 centres showed a high satisfaction and~     compliance of IBD-patients and health care workers with this telemedicine tool.~      The aim of this study is to compare standard care for IBD patients in 3 hospitals with a care~     via the telemedicine tool myIBDcoach.~   "
106531|NCT02172989|"~     Near-infrared (NIR) fluorescence imaging using indocyanine green (ICG) has been used for~     breast cancer surgery such as sentinel lymph node (SLN) mapping and breast cancer~     localization.~      In this study, our hypothesis are as following:~        1. As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure~          better outcome.~        2. indocyanine green (ICG) permitted accurate preoperative and intraoperative detection of~          the SLNs as well as nonpalpable benign brest lesion in patients with breast cancer.~   "
106532|NCT02172976|"~     In this multicenter study, patients with resectable pancreatic carcinoma will be treated with~     (a) surgery followed by 6 cycles gemcitabine or (b) 6 cycles FOLFIRINOX followed by surgery~     followed by 6 cycles FOLFIRINOX.~      The overall survival between both therapies will be compared as well as other parameters.~   "
106533|NCT02172963|"~     The purpose of this study is to evaluate the safety and efficacy using placenta derived~     decidual stromal cell therapy for hemorrhagic cystitis after allogeneic hematopoietic cell~     transplantation. It is hypothesized that the decidual stromal cell therapy is safe to infuse~     and that they have a positive clinical effect.~   "
106534|NCT02172950|"~     This multicenter, open-label, phase 3 extension study will investigate the safety and~     efficacy of rVIII‑SingleChain for prophylaxis and on‑demand treatment of bleeding episodes in~     at least 200 previously treated patients (PTPs) with severe congenital hemophilia A and~     previous exposure to FVIII products who achieve at least 100 exposure days (EDs) to~     rVIII-SingleChain in this study, as well as in at least 50 previously untreated patients~     (PUPs) with no previous exposure to any FVIII product who achieve at least 50 EDs to~     rVIII-SingleChain in this study. A substudy (open to both PTPs and PUPs) will investigate the~     use of rVIII-SingleChain in surgery. A substudy (open to PUPs who develop an inhibitor to~     rVIII-SingleChain) will investigate the use of rVIII-SingleChain in immune tolerance~     induction (ITI) therapy.~   "
106535|NCT02172937|"~     The purpose of this study is to evaluate safety and efficacy using decidual stromal cell~     therapy for graft versus host disease after allogeneic hematopoietic stem cell~     transplantation. The hypothesis to be tested is that the cells are safe to infuse and that~     they have a positive clinical effect.~   "
106536|NCT02172924|"~     The purpose of this study is to evaluate the safety and efficacy using decidual stromal cell~     therapy for graft versus host disease after allogeneic hematopoietic stem cell~     transplantation. The hypothesis to be tested is that the cells are safe to infuse and that~     they have a positive clinical effect.~   "
106537|NCT02172911|"~     This is an open-label study to evaluate the safety, tolerability, and immunogenicity of~     INO-3112 DNA vaccines delivered by Electroporation to female subjects with HPV-16 and/or~     18-positive cervical carcinoma.~   "
106538|NCT02172898|"~     To conduct a prospective, multicenter, observational study of patients with~     well-characterized alcoholic hepatitis (AH) and frequency matched individuals (by age,~     gender, and race) with comparable history of alcohol consumption but no clinical evidence of~     liver disease (controls). At the end of the study, a robust clinical information, central~     bio-repository will be developed from both cases and controls.~   "
106540|NCT02172872|"~     Older patients with acute myeloid leukemia (AML) have a small (< 10%) chance of long-term~     survival. Despite the treatment of elderly AML patients with intensive chemotherapy, the~     survival has not been improved during the last decades.~      The purpose of this study is to determine whether frontline therapy with a 10-day decitabine~     schedule provides a better survival than standard intensive combination chemotherapy in~     elderly AML patients (>= 60 years).~   "
106541|NCT02172859|"~     The purpose of this study is to determine whether a chronic dose of a tryptophan-rich protein~     drink (lumiVida™) can improve cognitive function, emotional processing and sleep in~     middle-aged women. In addition, also genetic predictors of susceptibility to an increase of~     Trp levels will be investigated.~      lumiVida™ is considered a dietary supplement, and therefore it is not an approved drug by the~     Food and Drug Administration (FDA). It is regulated like a food. The U.S. Food and Drug~     Administration does not strictly regulate herbs and dietary supplements. The investigators do~     not claim that this supplement is meant to treat any ailment~   "
106542|NCT02172846|"~     This phase I trial studies the side effects and best dose of hypofractionated proton beam~     radiation therapy when given together with paclitaxel and carboplatin in treating patients~     with stage II-III non-small cell lung cancer. Proton beam radiation therapy is a type of~     radiation therapy that uses streams of protons (tiny particles with a positive charge) to~     kill tumor cells. Giving proton beam radiation therapy at higher doses over fewer days~     (hypofractionation) may improve local control of the tumor. Giving hypofractionated proton~     beam radiation therapy with chemotherapy may be a better treatment for non-small cell lung~     cancer~   "
106543|NCT02172833|"~     Over the past few decades, a good number of studies with regard to coagulopathy and increased~     bleeding tendency which is defined as macro- or microscopic hemorrhage, declination of~     hemoglobin level, thrombocytopenia, and hypoprothrombinemia potentially caused by the use of~     antibiotics through a variety of suggested mechanisms, including myelosuppression,~     immune-mediated destruction of thrombocytes and coagulation factors, and suppression of~     vitamin K epoxide reductase or vitamin K-dependent γ-glutamate carboxylase which may lead to~     inhibition of biosynthesis of coagulation factor II, VII, IX, and X, have been reported or~     published. Nevertheless, many of them are case-series studies or case reports with low level~     of evidence, and there have been no large-scale retrospective cohort studies regarding~     antibiotic-associated coagulopathy being published. Moreover, in addition to exposure to~     antibiotics, there are several risk factors, including severity of illness, hepatic or renal~     function, nutrition status, comorbidities such as cancer and hematologic disease, surgery or~     other invasive procedure, concomitant use of anticoagulants, NSAIDs, and salicylates, and~     age, which may exert influence on the function of the coagulation system as well. Therefore,~     the study aims to clarify the association between the use of antibiotics and the increase of~     bleeding tendency or the development of bleeding event and to identify possible risk factors~     of the increase of bleeding tendency or the development of bleeding event in patients~     receiving antibiotic treatment through the application of nested case-control design and the~     usage of both the National Health Insurance Research Database (NHIRD) and medical records in~     National Taiwan University Hospital during the time period from January, 1995 to December,~     2013.~   "
106544|NCT02172820|"~     Participation in outpatient cardiac rehabilitation (CR) decreases morbidity and mortality for~     patients hospitalized with myocardial infarction, coronary bypass surgery or percutaneous~     revascularization. Unfortunately, only 10-35% of patients for whom CR is indicated choose to~     participate. Medicaid coverage and similar state-supported insurance are robust predictors of~     CR non-participation. There is growing recognition of the need to increase CR among patients~     with this form of insurance and other economically disadvantaged patients, but there are no~     evidence-based interventions available for doing so. In the present study we are examining~     the efficacy of using financial incentives for increasing CR participation among Medicaid~     patients. Financial incentives have been highly effective in altering other health behaviors~     among disadvantaged populations (e.g., smoking during pregnancy, weight loss). For this study~     are randomizing 130 CR-eligible Medicaid enrollees to a treatment condition where they~     receive financial incentives contingent on initiation of and continued attendance at CR~     sessions or to a usual-care condition where they will not receive these incentives.~     Treatment conditions will be compared on attendance at CR and end-of-intervention~     improvements in fitness, decision making and health-related quality of life. Cost~     effectiveness of the treatment conditions will also be examined by comparing the costs of the~     incentive intervention and usual care conditions with their effects on increasing CR~     initiation and adherence. Should this intervention be efficacious and cost-effective, it has~     the potential to substantially increase CR participation and significantly improve health~     outcomes among low-income cardiac patients.~   "
106545|NCT02172807|"~     Study to investigate the efficacy and safety of Ba679BR powder inhalation during the~     continuous once/day administration to the patients with COPD using oxitropium bromide~     (Tersigan® aerosol) as the comparator drug.~   "
106546|NCT02172794|"~     The primary objective of this study is to evaluate the effect of tiotropium on gross muscular~     efficiency~   "
106547|NCT02172781|"~     Comparative Pharmacokinetics and Pharmacodynamics of Tiotropium With Ipratropium or Placebo~     After 19 Days of Tiotropium Treatment~   "
106548|NCT02172768|"~     The primary objective of this trial is as follows:~      To determine the pharmacokinetics of micafungin given twice weekly in patients at risk for~     developing an invasive fungal disease (patients who are being treated for acute or chronic~     graft versus host disease; patients receiving reduced intensity conditioning for Stem Cell~     Transplant (SCT); receiving first remission induction chemotherapy for Acute Myeloid~     Leucaemia (AML)/MyeloDysplasticSyndrome (MDS)) compared to the pharmacokinetics of micafungin~     given daily.~      The secondary objective of this trial is as follows:~      To determine whether adequate exposure of micafungin is attained. To determine the safety of~     micafungin in this patient population~   "
106549|NCT02172755|"~     The purpose of this study is to determine the effects of age on the pharmacokinetic profile~     of BIA 2-093 and its active metabolites.~   "
106550|NCT02172742|"~     The purpose of this study is to investigate the effects of multiple-dose administration of~     BIA 2-093 on the steady-state pharmacokinetics of digoxin in healthy subjects.~   "
106578|NCT02172378|"~     Determine the effect of 12-week treatment with inhaled tiotropium bromide on lung function~     and static lung volumes, correlate this effect with dyspnoea in COPD patients.~   "
106551|NCT02172729|"~     To investigate whether increased dose of local anesthetic (lidocaine) increases duration of~     peripheral nerve block (adductor canal block) and to develop a model for assessing duration~     of peripheral nerve blockades. The investigators hypothesize that increasing the dose of~     lidocaine (by increased concentration) will increase the duration of an adductor canal block.~      The study is a follow up on an identical study (SM1-PJ-13, EudraCT number: 2013-001822-24 )~     made earlier with different concentrations of lidocaine and a placebo group. For further~     information see trial registration at European Union Drug Regulatory Authorities Clinical~     Trial System.~   "
106552|NCT02172716|"~     The primary objective of this study is to assess the short-term immune response of type-2~     diabetics with generalized chronic periodontitis (GCP) to nonsurgical periodontal treatment.~      The investigators hypothesize that type-2 diabetes exacerbates the disruption of DC~     (dendritic cells)-mediated immune homeostasis associated with periodontitis.~   "
106553|NCT02172703|"~     Introduction: Increased intracranial pressure (ICP) is considered to be the most important~     intracranial mechanism causing secondary injury in patients admitted after acute traumatic~     brain injury (TBI) and intracranial haemorrhage (ICB) including subarachnoid haemorrhage~     (SAH). Currently, ICP can be measured and monitored only using invasive techniques. The two~     ICP measurement methods available - intraventricular and intraparenchymal - require both a~     neurosurgical procedure in order to implant the catheter and probes within the brain. The~     invasiveness of current methods for ICP measurement limits the diagnoses reliability of many~     neurological conditions in which intracranial hypertension is a treatable adverse event. A~     reliable, accurate and precise non-invasive method to measure ICP would be of considerable~     clinical value, enabling ICP measurement without the need of a surgical intervention.~      Aim:~      The aim of this study is to validate a novel non-invasive ICP measurement device by comparing~     its measurement with the gold standard invasive ICP-measurement by intracranial probe. The~     device used in this study has been been developed in the Telematic Science Laboratory at the~     Kaunas University of Technology, Lithuania.~      Methods:~      The non-invasive ICP measurement method will be assessed prospectively using repeatable~     simultaneous non-invasive and invasive (standard with intracranial probe) ICP measurements on~     patients presenting with TBI and SAH. The device method is based on two-depth transcranial~     doppler (TCD) technique for simultaneously measuring flow velocities in the intracranial and~     extracranial segments of the ophthalmic artery (OA). The intracranial segment of the OA is~     compressed by ICP and the extracranial segment of the OA is compressed by the pressure Pe~     externally applied by the device. Two-depth TCD device is used as an accurate indicator of~     the balance point (Pe = ICP) when the measured parameters of blood flow velocity waveforms in~     the intracranial and extracranial segments of OA are identical. The device has the same~     ultrasound transmission parameters as existing TCD devices and meets all patient safety~     criteria.~   "
106554|NCT02172690|"~     RATIONALE: Laparoscopic staging may help doctors plan more effective treatment for gastric~     cancer, yet the efficiency have not been fully investigated in Chinese people.~      PURPOSE: Study the effectiveness of laparoscopic staging in patients with pre-diagnosed as~     locally advanced gastric cancer.~   "
106555|NCT02172677|"~     Schemas describe mental structures storing recurrent and organized pattern of information.~     Schemas may have a strong influence on the process of storing and retrieving new information~     into memory. Previous approaches in the cognitive neuroscience of memory have entirely~     focused on the individual dimension of preexisting schemas. In the real world though, much of~     our experiences and knowledge are collective or shared. Such social-cultural frameworks~     stored in collective memory may also reshape and reconfigure the construction of individual~     memories. Attempting to ascertain the influence of collective schema on the neural substrates~     of individual memories using cutting-edge brain imaging methods represents the challenge that~     MULTIBRAIN seeks to tackle. To achieve this goal, we will record brain activity in a group of~     24 participants while there are remembering pictures from a tour at the World War II Memorial~     of Caen. This study will seek to identify brain areas of the prefrontal cortex encoding the~     organization of knowledge in collective memory using multivariate analyses of brain patterns~     of activation, and then to understand how such regions might modulate the recruitment of the~     hippocampus during episodic memory retrieval using analyses of effective connectivity. The~     organization of knowledge in collective memory is measured in parallel through 1) the~     analysis of French social memory of World War II using a corpus of 100 000 television and~     radio shows from the National Institute of Audiovisual, and 2) an internet task measuring the~     organization of individual knowledge in a large group of individuals that will allow to~     separate shared from non-shared memories of the World War II. Once collected, these data will~     help us to understand how collective schemas may reconfigure the organization of individual~     memories.~   "
106556|NCT02172664|"~     The purpose of this prospective clinical trial will be to evaluate the efficacy of an FDA~     approved and marketed universal dental adhesive formulation in adult noncarious cervical~     lesions using self-etch and selective etch approaches.~      The hypothesis is that using a selective enamel etch with this universal adhesive will~     enhance the restoration margin performance.~   "
106557|NCT02172651|"~     This study seeks to learn more about the vitamin D receptor and its relationship to colon~     cancer. The Vitamin D receptor is found in colon cancer cells. When Vitamin D binds to the~     receptor in the cancer cells, it may stop cancer cells from growing abnormally and may cause~     cancer cell death. Vitamin D has been used in other research studies and information from~     those other research studies suggests that Vitamin D may help in the treatment of colon~     cancer.~      Participants will receive either high-dose vitamin D or standard-dose vitamin D. The study~     drug will be given 14-28 days prior to your surgery. The number of days will depend on when~     the surgery is scheduled.~   "
106558|NCT02172638|"~     The concept of Fast-trak or Enhanced Recovery After Surgery ( ERAS) represents a new approach~     to the management of patients undergoing major surgery that re-examine traditional practices,~     replacing them if necessary with the best evidence based practices, creating a multimodal~     perioperative care pathway designed to achieve early recovery. In Colorectal Cancer Surgery ,~     as well as in a number of other procedures it has been shown to reduce Hospitalization by~     more than 30% without increasing the rate complications or readmissions.~      However information on the results of Fast-track protocols when applied to Gynecological~     patients is sparse, being especially notorious the lack of data regarding the efficacy of~     Fast-track in the management of Advanced Gynecological cancer.~      Hypothesis: the application of a Fast-Track protocol in the management of patients with~     advanced Ovarian Cancer( Stage III, IV and relapses) may improve the postoperatory recovery~     of these patients allowing for an early discharge and significant cost reduction, when~     compared with de usual management, without increasing the number readmission or surgery~     related complications.~   "
106610|NCT02171962|"~     The objective of this study is to evaluate the Zilver® PTX® Drug-Eluting Peripheral Stent for~     treatment of lesions of the above-the-knee femoropopliteal artery in a Chinese patient~     population.~   "
106611|NCT02171949|"~     The purpose of this study is to evaluate the safety and efficacy of multiple infusions of~     mononuclear bone marrow cells in patients with chronic liver diseases.~   "
106559|NCT02172625|"~     Nutrition supplementation with antioxidants have been discussed as a way to further enhance~     overall well-being of athletes, promote faster recovery, and improve overall performance. The~     use of Protandim, a nutritional supplement containing 5 botanicals (Bacopa extract 150 mg;~     milk thistle 225mg; ashwagandha 150 mg; green tea 75 mg; turmeric 75 mg) has shown promise in~     an earlier study by reducing oxidative stress and increasing the amount of the anti-oxidant~     enzymes in the blood.~      The purpose of this study was to examine the effect of ~90 day Protandim supplementation on~     5-km running performance and on acute and long term oxidative damage as assessed by blood~     markers. Secondarily, another purpose of this study examined the effect of Protandim~     supplementation on other blood parameters (such as antioxidant enzyme concentrations) and~     measures of quality of life. The experiment was double-blind, placebo controlled. The study~     addressed two main questions and two secondary questions:~      Main Question 1: Does regular supplementation of Protandim (675 mg/day for 90 days) improve~     5-km running times? Hypothesis: Protandim would improve 5-km running time by 0.5 min (SD~     1-min). This is equivalent to an effect size of 0.5. The placebo group will have no change in~     performance.~      Main Question 2: Does regular supplementation of Protandim (675 mg/day for 90 days) reduce~     oxidative damage at rest as assessed by lipid peroxides (TBARS) in runners? Hypothesis: Based~     on the data by Nelson et al. (2006), oxidative damaged would be reduced by 40% (effect size =~     4.8).~      Secondary Question 1: Does regular supplementation of Protandim (675 mg/day for 90 days) in~     runners reduce the increase in oxidative damage post-race compared to pre-race as assessed by~     lipid peroxides (TBARS)? Hypothesis: Based on the data by Kyparos et al. (2009), we expected~     a 45% increase in TBARS post-exercise compared to pre-exercise (effect size of 3.6). However,~     we expected that those that are on Protandim for 90 days will only have 31% increase in TBARS~     post-race (effect size = 2.5) [based on changes in pre-post lipid peroxides from Arent et al.~     (2010)].~      Secondary Question 2: Does regular supplementation of Protandim (675 mg/day for 90 days)~     improve quality of life according to WHOQOL-BREF (Skevington, Lotfy, O'Connell, & Group,~     2004)? Hypothesis: There would be a statistical improvement in the quality of life~     post-Protandim supplementation which a small effect size improvement of 0.33.~   "
106560|NCT02172612|"~     This will be an eight-week, prospective, placebo-controlled, randomized trial to evaluate a~     patient-centered team (pharmacist-physician) intervention to improve medication~     appropriateness and reduce the use of inappropriate anticholinergic medications in elderly~     patients enrolled in the Sanders-Brown Alzheimer's Disease Center (ADC) cohort.~   "
106561|NCT02172599|"~     The purpose of this study is to examine the contribution of sit-stand workstations to total~     daily physical activity in a multi-component office-based 12 month intervention.~   "
106562|NCT02172586|"~     Study to assess the efficacy of telmisartan 40-80 mg once daily compared with losartan 50-100~     mg once daily in hypertensive patients evaluated by change from baseline in diastolic blood~     pressure (DBP) during the last 6 hours of the 24-hour dosing interval, at the end of the 12~     weeks period of monotherapy treatment (ABPM - ambulatory blood pressure measurement).~      Secondary objectives: Changes from baseline in BP at the end of the monotherapy period of~     treatment and at the end of the study, evaluated by sphygmomanometric blood pressure~     measurement and ABPM~      Safety:~      Incidence of adverse events (AE's); withdrawal due to adverse events; laboratory parameters~   "
106563|NCT02172573|"~     The objective of the study was to evaluate the efficacy and safety of SND 919 (pramipexole)~     tablets administered in combination with L-dopa in patients with Parkinson's disease using~     placebo and bromocriptine tablets as comparators in a double-blind design (phase III~     comparative study).~   "
106564|NCT02172560|"~     The objectives were to collect information on vital status and pulmonary medication use at~     the predicted exit date for patients who participated in two one-year trials and withdrew~     prematurely. The primary objective was to ascertain the vital status (dead or alive) of these~     patients in the time interval between the patients' withdrawal from the trial and their~     predicted exit date (i.e: 48 weeks from first intake of randomised treatment + 30 days). The~     secondary objective was to collect information on classes of pulmonary medication and some~     other specified pulmonary interventions used by these prematurely discontinued patients at~     the time of their predicted exit date (i.e 48 weeks from the first intake of randomised~     treatment + 30 days) or at date of death (if this occurred during the time interval of~     interest, i.e 48 weeks from the first intake of randomised treatment + 30 days).~   "
106565|NCT02172547|"~     Post marketing Surveillance to gain insights into the effects of therapy with Spiriva®~     (tiotropium bromide) on health-related quality of life in COPD patients who stopped smoking~     during treatment and to obtain safety data regarding adverse events.~   "
106566|NCT02172534|"~     Study to obtain information about the safety and tolerability of tiotropium bromide~     administered via the Respimat® inhalation device in pediatric (≤11 y.o.) and adolescent/adult~     (≥12 y.o.) cystic fibrosis (CF) patients after single and multiple doses as well as to obtain~     pharmacokinetic data for tiotropium in CF patients after single and multiple doses~   "
106567|NCT02172521|"~     -  Primary objective of this observational study was to gain insights into the effects of~          therapy with Spiriva® (tiotropium bromide) 18 microgram on the health-related quality of~          life and physical functioning in patients with chronic obstructive pulmonary disease~          (COPD) and demonstrated hyperinflation.~        -  Secondary objective was to obtain safety data regarding adverse events.~   "
106568|NCT02172508|"~     The primary objective of the study is to investigate the effect of the combined therapy 18 μg~     tiotropium q.d. plus pulmonary rehabilitation versus placebo plus pulmonary rehabilitation on~     6-minute walking distance (6MWD) after 7 weeks of treatment in patients with moderate to~     severe COPD. The secondary objective of the study includes assessments of the effects of the~     combined therapy 18 μg Tiotropium q.d. plus rehabilitation versus placebo plus rehabilitation~     on dyspnoea, constant work rate exercise endurance, daily activity and lung volumes. The~     third objective of the study is to investigate the correlation between the results of the~     6-minute walking test (6MWT), the constant work rate exercise test (CWR) and daily activity.~   "
106569|NCT02172495|"~     Post-marketing surveillance to gather information regarding the tolerance and efficacy of~     Spiriva® 18 micrograms in patients with COPD under conditions of daily practice.~   "
106570|NCT02172482|"~     As part of the post-marketing surveillance, information is to be gathered regarding the~     tolerance and efficacy of Spiriva® 18 micrograms in patients with COPD under conditions of~     daily practice~   "
106571|NCT02172469|"~     To compare the bronchodilator efficacy and safety of tiotropium inhalation capsules (18 µg~     once daily) and Atrovent® MDI (2 puffs of 20µg q.i.d.) among Filipino patients with COPD~   "
106572|NCT02172456|"~     Primary endpoint: whole lung deposition and in-vivo distribution pattern of a 99mTc-labelled~     tiotropium powder formulation following inhalation via HandiHalerTM in healthy subjects as~     well as in patients with mild, moderate and severe COPD~      Secondary endpoints: pharmacokinetics, pharmacodynamics (effect on lung function), safety and~     tolerability~   "
106573|NCT02172443|"~     The objective of this study is to compare the bronchodilator efficacy and safety of~     tiotropium inhalation capsule (18 mcg once daily) and Atrovent MDI (2 puffs of 20 mcg q.i.d.)~     in patients with chronic obstructive pulmonary disease (COPD)~   "
134499|NCT01806818|"~     Multi-center Study to Compare Efficacy and Safety between Eperisone a BID and a TID Regimen~     in Acute Low Back Pain Patients during 7 days.~   "
106579|NCT02172365|"~     The investigators will evaluate the outcomes of allogeneic stem cell transplantation which is~     the only curative treatment modality in the patients with chronic myeloid leukemia after~     failing tyrosine kinase inhibitor therapy. However, any update was not reported on the~     transplant outcomes in the patients failed TKI therapy, thus necessitating update of this~     data. Also, the European Group for Blood and Marrow Transplantation (EBMT) risk score is~     still of value, but insufficient numbers of patients have been transplanted in recent years~     and after TKI therapy to allow a robust reanalysis. Our study hypothesis is that allogeneic~     SCT treatment modality can rescue CML patients who failed TKI therapy due to resistance or to~     intolerance with improved survival and long-term outcomes. Also, another hypothesis will be~     examined if the EBMT risk score proposed pre-imatinib era can reproduce similar prognostic~     risk stratification of long-term outcomes in the patients treated with TKI.~   "
106580|NCT02172352|"~     To investigate the dose response following single inhalation of Ba 679 BR inhalation powder~     in COPD patients using pulmonary functions as indicators, and to compare data obtained with~     overseas study findings~   "
106581|NCT02172339|"~     Study to investigate pharmacokinetics of a single i.v. dose of tiotropium (4.8 mcg) in~     patients with renal impairment in comparison to healthy subjects.~   "
106582|NCT02172326|"~     Study to evaluate the pharmacokinetics of tiotropium following 14 days of administration~     (18µg once per day) in elderly COPD patients.~   "
106583|NCT02172313|"~     This trial is conducted in Europe. The aim of the trial is to investigate the effect of food~     on the pharmacokinetics (the exposure of the trial drug in the body) of oral semaglutide, in~     a SNAC (sodium N-[8-(2-hydroxybenzoyl) amino] caprylate) tablet formulation with three~     different dosing conditions in healthy subjects.~   "
106584|NCT02172300|"~     Study to investigate whether tiotropium therapy can increase duration of steady-state~     exercise by decreasing dynamic and static lung hyperinflation in COPD patients.~   "
106585|NCT02172287|"~     To compare the long -term (six month) bronchodilator efficacy and safety of tiotropium~     inhalation capsules, salmeterol inhalation aerosol and placebo in patients with COPD. A~     secondary objective of this study was to compare the impact of tiotropium and salmeterol on~     humanistic and economic health outcomes, such as quality of life, patient preference and~     Health Resource Utilisation in this patient population.~   "
106586|NCT02172274|"~     Study to determine the pharmacokinetics of BI 10773 and total radioactivity including~     excretion mass balance, excretion pathways and metabolism following the oral administration~     of [14C] BI 10773~   "
106587|NCT02172261|"~     The objective was to investigate whether there was a drug-drug interaction between BI 10773~     and glimepiride when co-administered. Therefore, the relative bioavailabilities of BI 10773~     and glimepiride were determined when both drugs were given in combination compared to~     multiple oral doses of BI 10773 once daily alone and a single oral dose of glimepiride given~     alone.~   "
106588|NCT02172248|"~     The objective was to investigate a possible drug-drug interaction between BI 10773 and~     metformin when co-administered as multiple oral doses. Therefore, the relative~     bioavailabilities of BI 10773 and metformin were determined when both drugs were given in~     combination compared with BI 10773 or metformin given alone.~   "
106589|NCT02172235|"~     The objective was to investigate the effect of different doses of BI 10773 on the~     bioavailability of pioglitazone after multiple oral doses of both drugs~   "
106590|NCT02172222|"~     Study to investigate the relative bioavailability of BI 10773 and of linagliptin after~     concomitant multiple oral administration of 50 mg BI 10773 tablets and 5 mg linagliptin in~     comparison to 50 mg BI 10773 and 5 mg linagliptin given alone.~   "
106591|NCT02172209|"~     Trial to assess the effect of food on the pharmacokinetics and the extent of absorption of a~     single dose BI 10773 tablet in healthy subjects~   "
106592|NCT02172196|"~     The objective was to investigate whether there was a drug-drug interaction between BI 10773~     and sitagliptin when co-administered as multiple oral doses. Therefore, the relative~     bioavailabilities of BI 10773 and sitagliptin were determined when both drugs were given in~     combination compared with BI 10773 or sitagliptin given alone.~   "
106593|NCT02172183|"~     This is the first randomized controlled study that tests the efficacy of a~     cognitive-behavioral group therapy (CBT) on adolescents with ADHD who were in pharmacological~     treatment but still presented persistent symptoms.~   "
106594|NCT02172170|"~     Study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of single~     rising oral doses of BI 10773 to healthy male subjects.~   "
106595|NCT02172157|"~     Primary objective:~      To determine the basic pharmacokinetics of BI 1744 BS, its metabolite BI 1744 BS -~     glucuronide and [14C]-radioactivity including excretion mass balance, excretion pathways and~     metabolism following intravenous and oral administration of [14C]BI 1744 CL~      Secondary objective:~      To determine safety and tolerability following intravenous and oral administration of [14C]BI~     1744 CL in healthy male subjects~   "
106596|NCT02172144|"~     Study to investigate the effect of BI 1744 CL on the QT/QTc interval of the ECG~     (electrocardiogram) in comparison to placebo~   "
106597|NCT02172131|"~     To investigate safety, tolerability, and pharmacokinetics (PK) of single i.v. doses of BI~     1744 CL~   "
106598|NCT02172118|"~     Study to assess the influence of severe renal impairment on the pharmacokinetics (PK),~     safety, and selected pharmacodynamic (PD) parameters of BI 1744 CL (30 μg administered by~     inhalation with the Respimat® Inhaler)~   "
106599|NCT02172105|"~     Study to evaluate safety, tolerability, and pharmacokinetics of BI 1744 CL in healthy~     Japanese male volunteers.~   "
106600|NCT02172092|"~     The purpose with the study is to follow the fluid shifts that occur during fluid~     resuscitation of patients with diabetic ketoacidosis.~      In the study measurements of changes in blood and urine concentrations of Sodium and Chloride~     as well as blood hemoglobin are used to mathematically calculate changes in distribution~     volumes of these different endogenous markers.~   "
106625|NCT02171767|"~     Study to assess pharmacokinetics incl. dose proportionality, safety and tolerability of 4~     different dosage strengths of BIBW 2992 tablets (final formulation of 20 mg, 30 mg, 40 mg, 50~     mg) administered as single doses to healthy male volunteers~   "
106626|NCT02171754|"~     The objective was to investigate the effect of ritonavir, an inhibitor of P-glycoprotein~     (P-gp) and cytochrome P450 3A4 (CYP3A4), on the pharmacokinetics of BIBW 2992~   "
106601|NCT02172079|"~     Controversy exists regarding the effectiveness of manual therapy techniques for the~     management of impingement syndrome. However, no adequately powered clinical trials have~     examined the effects of mobilization-with-movement. The purpose of the current study was to~     perform a randomized controlled trial comparing the effects of real MWM to a group receiving~     a sham intervention on shoulder pain at different moments and active shoulder range of motion~     in an adequately powered sample of patients with shoulder impingement syndrome.~   "
106602|NCT02172066|"~     In the aftermath of natural disasters, e.g., flood disasters, there is a great need for~     humanitarian assistance in the domain of psychological support. This is particularly true in~     post-conflict settings because people have suffered severely from multiple traumatic events~     and situations during their lives. The Narrative Exposure Therapy (NET) is a short-term,~     culturally sensitive treatment approach that aims to reduce Posttraumatic Stress Disorder~     (PTSD) symptoms.~      The investigators want to provide evidence, that NET is an effective and efficient module to~     assist people in the aftermath of natural disasters using the example of the recent flood~     disaster in Burundi. In addition the investigators aim to explore, how traumatic incidences~     and maltreatment during childhood may influence treatment outcomes.~   "
106603|NCT02172053|"~     Studies show that exercise resistance in workplace can reduce the symptoms of induced labor,~     however, the effectiveness of such programs depends on the characteristics of the training~     fatigue. Thus, it is expected that this study the intervention group with training heavy~     using progressive resistance exercise protocol will be better in reducing fatigue when~     compare with light training group.~   "
106604|NCT02172040|"~     The purpose of this study is to evaluate the effect of celecoxib on the efficacy and safety~     of amlodipine besylate in subjects with hypertension requiring antihypertensive therapy.~      This study is being conducted to support a future marketing application for KIT-302, an oral~     fixed combination drug product (FCDP) consisting of the antihypertensive drug amlodipine~     besylate and the non-steroidal anti-inflammatory drug (NSAID) celecoxib.~      KIT-302 is being developed as a convenience reformulation FCDP to facilitate and improve~     patient compliance with the once a day administration of its individual components,~     amlodipine and celecoxib, when used together for the treatment of hypertension in patients~     who also require the use of an NSAID for relief of the signs and symptoms of osteoarthritis.~      Although the final KIT-302 formulation will be a single capsule, for this study, two separate~     capsules will be utilized: one containing a commercial celecoxib capsule (Celebrex®) or~     matched placebo capsule and one containing a commercial amlodipine besylate tablet (Norvasc®)~     or matched placebo tablet.~      The study hypothesis is that treatment with the amlodipine besylate containing capsule plus~     the celecoxib containing capsule will reduce blood pressure (BP) in subjects with~     hypertension with an efficacy that is not substantially inferior to the effect of amlodipine~     besylate alone (i.e., the amlodipine containing capsule plus the matched placebo for the~     celecoxib capsule).~   "
106605|NCT02172027|"~     Pleural effusion in lung cancer patients is one of the symptoms of metastatic disease that is~     inoperable and cannot be treated. Identification of cancer cells in the pleural effusion of~     lung cancer patients is a cytological test and serves as an initial diagnosis. These cells~     can then be used to prepare a cell block for staining and further tests.~      In some research despite clinical suspicions, the cytological diagnosis is negative, due to~     the specimen containing too few cells or damage to the cells whilst the specimen is~     processed. A new method of identifying rare cells in a fluid is by immunomagnetic separation.~     Using this method, an antigen binds to proteins in the cell wall that are unique to tumor~     cells. When the fluid is passed through a magnetic field, separation occurs of the cells with~     the magnetic tags from the remainder of the cells. The separated cells can then be stained or~     cultured.~      The currently approved method of immunomagnetic detection has been approved for clinical use~     in patients with breast cancer, cancer of the intestines and prostate cancer. An Israeli~     Biotech company has developed an advanced technology that allows identification of a larger~     number of cells without causing morphological damage to the cells.~      The purpose of the current study is to examine the technique of immunomagnetic separation in~     pleural effusion of lung cancer patients in comparison to the cytological tests. In the~     future it is hoped that a larger number of patient samples will be included and further~     characterization of the cells will be possible to be compared to the clinical and cytological~     characteristics.~   "
106606|NCT02172014|"~     Title: Safety and efficacy of fentanyl citrate in combination with midazolam in critically~     ill children with mechanical ventilation~      Objective: To evaluate the safety and efficacy of fentanyl citrate in combination with~     midazolam in children with mechanical ventilation.~      Design: Double-blind randomized controlled study~      Patients: Patients age 2 months through 18 years who are admitted in Seoul National~     University Hospital pediatric intensive care unit, and applied with mechanical ventilation.~      Interventions: After enrollment of patient, blind reagent (fentanyl citrate or normal saline)~     is prepared by assigned pharmacist. Investigators, caregivers, patient, and parents of the~     patient don't know whether the blind reagent is fentanyl citrate or not, but only preparing~     pharmacist knows that.~      Protocol: All enrolled patients receive continuous infusion of midazolam and blind reagent.~     The start time of study is when the continuous infusion of midazolam and blind reagent are~     begun. Assigned research nurse check Comfort behavior scale of the patient every hour~     regularly, and whenever the patient seem to be overactive. Endpoint of the study is 48 hours~     after begining. If there is any adverse effect or unexpected event, however, the study can be~     early terminated.~   "
106607|NCT02172001|"~     The primary objective of the study is to evaluate and compare the effect of iron isomaltoside~     1000 to placebo in its ability to increase haemoglobin (Hb) in subjects with IDA when oral~     iron preparations are ineffective or cannot be used.~   "
106608|NCT02171988|"~     The purpose of the study is to investigate effect of medical treatment and prognosis of~     Postural Orthostatic Tachycardia Syndrome (POTS)~   "
106609|NCT02171975|"~     Multiple passes and attempts while administering spinal anesthesia are associated with a~     greater incidence of post dural-puncture headache, paraesthesia and spinal hematoma. The~     investigators hypothesised that the routine use of pre-procedural ultrasound-guided~     paramedian spinals reduces the number of passes required to achieve enter the subarachnoid~     space when compared to the conventional landmark-guided midline approach.~   "
106612|NCT02171936|"~     In the care of the chronic pain in pain's department, pain consultation or Evaluation and~     Treatment of the Pain Center (CETD), the patients are often in a situation of physical and~     psychic suffering which requires a multidisciplinary follow-up. So, 19 percent of the chronic~     painful patients lost their employment, are disintegrated because of their pain, this being~     able to provocate a loss of their financial autonomy. A large number of painful patients thus~     find themselves in situations of social vulnerability even of precariousness often denied and~     difficult to detect by the caring team. Precarity is define as  the lack of one or several~     securities, in particular the employment, allowing the people and the families to assume~     their professional, family or social obligations, and to enjoy their fundamental rights. To~     allow a earlier identification of the populations in deprivation situation, the questionnaire~     EPICES (Evaluation of the Precariousness and the Disparities of health for the Centers of~     Examination of Health (CES)) was administered to more than 7000 people. The individual score,~     indicator of the precariousness and the disparities of health, is calculated after answer to~     11 questions and was calculated on about 200 000 French people. Among numerous indicators, it~     appears that the consumption of psychotropics or a negative perception of the health are~     socioeconomic indicators, mode of life and health which are prevailing according to the~     quintiles of the score EPICES.~      This national study, on the French CETD aims is: 1 - to study prevalence of the social~     vulnerability even of the precariousness thanks to adapted questionnaires of which the~     questionnaire EPICES, 2 - to identify predictive social-economic factors which generate and~     amplify this circumstance, 3 - to identify the patients for whom a situation of~     precariousness and social vulnerability is proved true, justifying the earlier orientation~     towards the social worker of the Center so allowing a global care of the patient during the~     second visit~   "
106613|NCT02171923|"~     To examine whether the medial prefrontal cortex displays an increased activity during~     self-referential processing among remitted depressed patients compared to healthy controls~   "
106614|NCT02171910|"~     Sedation is needed in order to complete endoscopic retrograde cholangiopancreatography (ERCP)~     to alleviate discomfort and pain during the procedure. This is usually achieved with use of~     opioids and/or sedative agents such as benzodiazepines or propofol. Traditionally~     benzodiazepines have been used but nowadays propofol is becoming the drug of choice for~     sedation during ERCP.~      The problem with propofol sedation is the fact that it may case cardiorespiratory depression~     and there is no antidote for this like there is for benzodiazepines. Cardiovascular~     depression can usually be easily counteracted with drugs that are used to raise blood~     pressure or heart rate during general anesthesia but respiratory depression remains a~     problem.~      The aim of this study is to try to counteract the respiratory depression caused by propofol~     sedation using an old respiratory stimulant doxapram as opposed to placebo using a double~     blind randomized protocol.~      The investigators hypothesis is that boluses and an infusion of doxapram will alleviate the~     respiratory depression caused by propofol sedation.~   "
106615|NCT02171897|"~     This is a single-centre, comparative, prospective randomised trial. It will include 70~     patients over a period of 2 years randomized into two groups of 35 patients: one group of~     patients treated with osteosynthesis (plate, nail or screw) and the second group treated with~     total hip replacement.~      The Harris and PMA functional scores will be assessed at 6 weeks, 3 months, 6 months and 1~     year.~      The time to recovery of weight-bearing, the subjective satisfaction score, the EQ5D quality~     of life questionnaire, the VAS score for pain at rest and when walking, the Parker score, the~     rate of complications and deaths will also be measured. Operating time, blood loss and scar~     size will also be evaluated.~   "
106616|NCT02171884|"~     For this project, 4 groups of 38 infants have been created so as to evaluate the impact of~     Assisted-Reproduction Technology (ART) and more particularly the two procedures classically~     used in ART: the freezing/thawing of embryos and prolonged embryo culture (five days of~     culture in appropriate in vitro conditions to allow development of the embryo) in contrast~     with shorter culture of only two days.~      Participation consists in accepting samples to be taken at the birth of the infant:~        1. from the umbilical cord.~        2. from the placenta.~   "
106617|NCT02171871|"~     The study will examine changes in the respiratory system mechanics and in respiratory~     physiology after exposure of subjects to passive smoking. It is about healthy non-smoking~     volunteers and it will be carried out through the techniques of forced oscillation with~     Impulse Oscillometry (IOS) technique methodology and nitrogen washout.~      The present study will contribute to the understanding of passive smoking consequences on the~     respiratory system of healthy non-smokers. Thanks to the nitrogen washout technique, changes~     to closing volume and closing capacity will be examined during measurement in different~     positions (sitting, decubitus) together with exposure to passive smoking. With IOS~     methodology, changes in respiratory system resistance in four positions (standing, sitting,~     right and left lateral decubitus) will be evaluated before and after exposure to a passive~     smoking environment. Results of the present study are expected to provide interesting~     information on the changes in measured parameters not only in different positions but also~     after exposure to smoking.~   "
106618|NCT02171858|"~     Stroke is one of main causes of death and impairment worldwide. Objective of this study is to~     analyze serum High Sensitivity C-Reactive Protein in acute phase stroke in patients attended~     at Petróleos Mexicanos Hospital Central Sur de Alta Especialidad and to correlate with stroke~     extension and clinical features.~   "
106619|NCT02171845|"~     This is a single-centre study over 36 months for the inclusion of 30 patients. The selection~     and inclusion of patients will take place according to the criterion of Medical Termination~     of Pregnancy at 4 different gestational ages (8-12 weeks of gestation (WG)), 13-16 WG, 17-23~     WG and 25-35 WG. The tissue analysed will principally be the gonads, other somatic tissue~     will also be systematically harvested in parallel (liver and psoas muscle) for control~     purposes. The gonads will be subjected to molecular biology analyses destined to quantify the~     expression of transposons and their inhibitors.~   "
106620|NCT02171832|"~     The main objective of this study was to investigate the influence of mild and moderate liver~     impairment on the pharmacokinetics, safety and selected pharmacodynamic parameters of BI 1744~     CL in comparison to a control group with normal hepatic function after single orally inhaled~     administration of BI 1744 CL with the Respimat® Inhaler.~   "
106621|NCT02171819|"~     This is a first-in-human study of safety and immunogenicity of an A/H5N1 inactivated whole~     cell vaccine manufactured by the IVAC in Vietnam when given in two injections in two doses~     (low and high) compared to a placebo in 76 healthy adult subjects in Vietnam.~   "
106622|NCT02171806|"~     To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 1744 CL~   "
106623|NCT02171793|"~     Study to investigate safety, tolerability, and pharmacokinetics of single rising peroral~     doses of BI 1744 CL.~   "
106624|NCT02171780|"~     To investigate safety, tolerability, and pharmacokinetics of BI 1744 CL~   "
106649|NCT02171455|"~     To assess safety, pharmacokinetics and the effect of dabigatran on coagulation parameters~     prior to administration of a high dose of dabigatran etexilate in a QT study~   "
106627|NCT02171741|"~     Study to determine the maximum tolerated dose (MTD) for various treatment durations of BIBW~     2992 when administered in combination with docetaxel as determined by drug-related adverse~     events (AEs) as well as Pharmacokinetics, overall safety and antitumor efficacy.~   "
106628|NCT02171728|"~     Investigation of maximum tolerated dose (MTD), safety, pharmacokinetics, pharmacodynamic~     parameters, and efficacy of BIBW 2992~   "
106629|NCT02171715|"~     The primary objective of the study was to investigate the relative bioavailability and~     pharmacokinetics of 20 mg BIBW 2992 administered as film-coated immediate release tablet~     (final formulation, i.e. phase III/to-be-marketed formulation) to healthy subjects in~     comparison with the drinking solution and in comparison with the trial formulation II tablet,~     which was administered in phase II clinical trials and also partly in phase I trials.~   "
106630|NCT02171702|"~     The primary objective of the study was to identify the maximum tolerated dose and to evaluate~     safety, pharmacokinetics, pharmacodynamic parameters, and efficacy of BIBW 2992.~   "
106631|NCT02171689|"~     The aim of the study was to investigate the metabolism and pharmacokinetics of BIBW 2992 MA2~     after a single oral dose of [14C]-radiolabelled BIBW 2992 MA2 in healthy male volunteers.~     Metabolites in human plasma and excretions were measured, the structures of the metabolites~     analysed and compared with metabolites in animals. In addition, the mass-balance of~     excretion, the protein binding of [14C]-radioactivity, the plasma concentrations of BIBW 2992~     MA2, and the [14C]-radioactivity in blood cells, plasma, urine and faeces were measured. The~     safety and tolerability of BIBW 2992 were also investigated.~   "
106632|NCT02171676|"~     Maximum tolerated dose (MTD), safety, pharmacokinetic and pharmacodynamic parameters, and~     efficacy of pulsatile administration of BIBW 2992 in combination with docetaxel (Taxotere®)~   "
106633|NCT02171663|"~     The primary objective was the assessment of safety of BIBW 2992 as assessed by the maximum~     tolerated dose (MTD). Secondary objectives were collection of overall safety data, antitumor~     efficacy data, as well as the determination of pharmacokinetics and the pharmacodynamic~     modulation of biomarkers by BIBW 2992.~   "
106634|NCT02171650|"~     The primary objective was to collect safety data for BIBW 2992.~   "
106635|NCT02171637|"~     Evaluation of maximum Tolerated Dose (MTD), safety, pharmacokinetics, efficacy of BIBW 2992,~     pharmacodynamic modulation of biomarkers, correlation of Epidermal Growth Factor Receptor~     (EGFR) and Human EGF-like Receptor number 2 (HER2) immunohistochemical status with objective~     tumour responses~   "
106636|NCT02171624|"~     Open-label, two-way crossover design with a quinidine sulfate run-in period followed by a~     randomised sequence of dabigatran etexilate plus quinidine sulfate or dabigatran etexilate~     alone to evaluate the safety of co-administration of dabigatran etexilate and quinidine. and~     the pharmacokinetic interaction between quinidine and dabigatran etexilate.~   "
106637|NCT02171611|"~     To determine the relative bioavailability of 150 mg of dabigatran etexilate as pellets on~     food and of 150 mg of dabigatran etexilate as powder resolved in reconstitution solution,~     both with 150 mg of dabigatran etexilate as capsule in healthy volunteers~   "
106638|NCT02171598|"~     The primary objective of the study (Main Part 2) was to investigate whether and to which~     extent a combination of multiple oral doses (steady state conditions) of 75 mg of clopidogrel~     q.d. (after a loading dose of 300 mg) and multiple doses of 150 mg of dabigatran etexilate~     b.i.d. at steady state affects pharmacokinetic and pharmacodynamic parameters of dabigatran~     etexilate and clopidogrel.~      The objective of the preceding Pilot Part 1 of the study was to explore the effect of a~     single dose of 300 mg clopidogrel administered after multiple doses of 75 mg and 150 mg~     dabigatran had reached steady state, regarding safety as well as pharmacokinetic and~     pharmacodynamic parameters.~      The Main Part 3 of the study moreover was to compare intra-individually the effects of a~     single dose of 600 mg clopidogrel with the same dose, 600 mg clopidogrel, given additionally~     to multiple doses of 150 mg dabigatran in steady state condition with respect to safety and~     pharmacokinetic and pharmacodynamic parameters.~   "
106639|NCT02171585|"~     To investigate whether and to what extent the reported potent P-gp inhibitor clarithromycin~     affects pharmacokinetic parameters (area under the curve (AUC) and maximal concentration~     (Cmax)) of dabigatran.~   "
106640|NCT02171572|"~     The objective of the current study is to investigate safety, tolerability and,~     pharmacokinetics of dabigatran etexilate following oral administration of single and multiple~     oral doses (110mg, 150 mg b.i.d., 7 days) in healthy Chinese subjects.~   "
106641|NCT02171559|"~     To investigate the relative bioavailability and the pharmacodynamics of dabigatran after~     switching from enoxaparin to dabigatran etexilate as compared to dabigatran etexilate alone~   "
106642|NCT02171546|"~     Part 1: To investigate the effect of quinidine, a P-glycoprotein (P-gp) probe inhibitor on~     the bioavailability of dabigatran etexilate,~      Part 2: To determine the effect of quinidine on the bioavailability of fexofenadine, a probe~     substrate for P-gp~   "
106643|NCT02171533|"~     To investigate whether and to what extent the P-glycoprotein inhibitor (P-gp) verapamil~     affects the pharmacokinetic parameters of dabigatran with verapamil given at different~     dosages, in different formulations (immediate release (IR) and extended release (ER)), and in~     different intervals in relation to the dabigatran dose.~   "
106644|NCT02171520|"~     The objective was to demonstrate the bioequivalence of capsules made from 2 different drug~     product batches. The reference batch was representative of the current commercial drug~     product and of the pivotal Phase III batches. The test batch was the drug product batch~     intended for future commercial use.~   "
106645|NCT02171507|"~     To investigate the relative bioavailability of dabigatran with and without concomitant~     administration of diclofenac and the relative bioavailability of diclofenac with and without~     concomitant administration of dabigatran etexilate~   "
106646|NCT02171494|"~     To establish the bioequivalence of 2x5 mg of IVAX warfarin /formulation tablet vs. 10 mg of~     Coumadin / formulation tablet~   "
106647|NCT02171481|"~     To establish the bioequivalence of two polymorphs of dabigatran etexilate, polymorph I and~     polymorph II~   "
106648|NCT02171468|"~     To investigate and compare pharmacokinetics, safety and pharmacodynamics of dabigatran~     etexilate following oral administration of multiple doses (110 mg and 150 mg b.i.d., 7 days)~     in healthy male subjects between Japanese and Caucasians~   "
106651|NCT02171429|"~     This Phase III, double-blind, placebo and active comparator controlled, multicenter study~     will investigate the efficacy and safety of etrolizumab in induction of remission in~     participants with moderately to severely active UC who are naIve to TNF inhibitors and~     refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment.~   "
106652|NCT02171416|"~     Cold contact urticaria (CCU) is a frequent form of physical urticaria that is characterized~     by the development of wheal and flare type skin reactions due to the release of histamine and~     other proinflammatory mast cell mediators following exposure of the skin to cold. Typically,~     symptoms occur within minutes after cold contact, including exposure to cold air, liquids or~     objects and are limited to cold exposed skin areas.~      The investigators postulate that there is an overlap between acquired cold urticaria and~     cold-induced autoinflammatory syndromes, and that cold urticaria patients unresponsive to~     antihistamines will benefit from IL-1 targeting treatment strategies.~      This study will evaluate the efficacy and safety of the IL-1 transfusion protein rilonacept~     in patients with cold contact urticaria who could not be successfully treated with first-line~     medication such as antihistamines.~      This is a double-blind placebo-controlled parallel group phase II study of the efficacy and~     safety of rilonacept in subjects with CCU. A total of 20 patients will be included by the~     Urticaria specialty clinics of ACC. The total duration of the study course for each patient~     is 14 weeks and is divided in:~        1. Screening period (2 weeks, days -14-0)~        2. Placebo-controlled double-blind phase (Part A, 6 weeks, days 0-42)~        3. Open label phase (Part B, 6 weeks, days 42-84) All eligible patients will be randomized~          (1:1 randomization) to one of two groups: 1) Rilonacept 160mg/week or 2) Placebo, and~          will receive the respective dose subcutaneously. Following the placebo-controlled~          double-blind phase patients will enter the open-label phase and receive rilonacept~          open-label treatment (160mg or 320mg depending on treatment response during part A).~   "
106653|NCT02171403|"~     Most people are born with the ability to digest lactose, a dissacharide consisting of~     β-D-glucose and β-D-galactose, because of the presence of lactase at the brush border of the~     small intestine. In about 75% of the world population the activity of this enzyme decreases~     after weaning (primary hypolactasia or lactase-nonpersistence), resulting in incomplete~     digestion of lactose and lactose malabsorption in adulthood (1). Secondary forms of lactose~     malabsorption may be due to inflammation or functional loss of the intestinal mucosa such as~     celiac disease, infectious enteritis or Crohn's disease. Very rarely, lactase deficiency is~     congenital due to an autosomal recessive genetic disorder, preventing lactase expression from~     birth (2). Whereas some people with lactose malabsorption are asymptomatic, most~     lactose-nonpersisters experience symptoms like abdominal pain, bloating, excess flatulence or~     diarrhea. Lactose intolerance refers to the syndrome of having one or more symptoms after~     consumption of lactose-containing food (3). At present, the origin of the symptoms of~     lactose-intolerance is not well understood.~      Several studies have indicated a poor correlation between lactose maldigestion and symptoms~     of lactose intolerance (4). In a study by Vonk et al. (2003), lactose intolerant subjects~     with severe symptoms (diarrhea) and intolerant subjects with only mild symptoms (without~     diarrhea) did not differ in degree of lactose digestion in the small intestine indicating a~     similar lactase activity and leading them to the hypothesis of a colon resistence factor~     (5). It was suggested that the colonic processing of maldigested lactose may play a role in~     the symptoms experienced by lactose intolerant patients. When lactose is malabsorbed and~     enters the colon, it is rapidly fermented by the resident microbiota into a variety of~     metabolites including lactate, formate, succinate and short chain fatty acids (SCFA, acetate,~     propionate, butyrate) as well as gases (H2, CO2 and CH4). When incubating fecal samples from~     lactose-tolerant and intolerant subjects with lactose, the samples from the~     lactose-intolerant subjects showed faster production rates of D- and L-lactate, acetate,~     propionate and butyrate, as compared to tolerant subjects (6). Although the colon is thought~     to possess a high capacity to absorb SCFA, it was hypothesized that a temporary accumulation~     of these metabolites due to rapid fermentation of maldigested lactose could be responsible~     for abdominal pain, excess flatulence and bloating (7;8). Possible mechanisms proposed to~     explain how SCFA might induce symptoms included an increase in the osmotic load that draws~     fluid to the colonic lumen, changes in colonic motility and an increased colonic sensitivity~     (9-11). However, the calculated amount of fluid drawn in the colon is unlikely to cause~     symptoms considering the high water absorbing capacity of the colon and the effect of SCFA on~     colonic motility and colonic sensitivity have only been observed in rats and not in humans.~      More recently, Campbell et al. introduced the bacterial metabolic toxin hypothesis, stating~     that also other bacterial metabolites, such as alcohols, aldehydes, acids and ketones,~     resulting from carbohydrate fermentation play a role in the pathogenesis of~     lactose-intolerance. These metabolites might inhibit bacterial growth and affect eukaryotic~     cells (12). In our own previous studies in which we related colonic fermentation patterns to~     parameters of cytotoxicity, we identified compounds like propionic acid, medium chain fatty~     acids, 1-octanol and heptanal as more prevalent in the most cytotoxic samples (13),~     supporting the hypothesis of Campbell et al. Therefore, it seems necessary to include not~     only SCFA, but also other metabolites, in the investigation of the pathogenesis of lactose~     intolerance.~      Differences in fermentation patterns might be associated with differences in the composition~     and/or activity of the intestinal microbiota. Evidence on the potential role of the colonic~     microbiota in lactose intolerance is very limited. Total bacterial numbers were not~     significantly different between 16 intolerant and 11 tolerant lactose maldigesters although a~     negative correlation between total bacteria and symptom score was found (14). Similarly, the~     composition of fecal microbiota was not different between 5 intolerant and 7 tolerant~     subjects (6).~   "
106654|NCT02171390|"~     The study searched for answers to two questions~        1. Is there endothelial dysfunction, inflammation and insulin resistance in patients with~          congenital hypogonadotropic hypogonadism?~        2. What is the effect of testosterone replacement therapy on endothelial dysfunction,~          inflammation and insulin resistance?~   "
106655|NCT02171377|"~     Quadricipital electrical stimulation added to respiratory rehabilitation in COPD patients.~      Quadricipital electrical stimulation (ES) in chronic obstructive pulmonary disease (COPD)~     patients has been demonstrated to improve both dyspnea and physical status. The aim of our~     study is to demonstrate that ES added to respiratory rehabilitation program induces a greater~     improvement on exercise tolerance in such patients.~      Design : 160 patients with severe COPD will be randomly assigned to 2 groups : either~     rehabilitation program (group 1), either ES and rehabilitation program (group 2). In both~     groups, rehabilitation program comprises endurance training, 18 - 24 sessions (6 - 8 weeks),~     health education, global muscular strengthening. In group 2, bilateral quadricipital~     electrical stimulation 30 min sessions is added 5 days / week.~      Subjects : COPD patients with FEV1 < 60% pred, FEV1/VC < 70%, and TLC > 80%, with dyspnea, in~     stable conditions, and 18 > BMI < 35 kg/m² .~      Intervention : 6 min walking distance, incremental exercise test data (aerobic capacity, work~     rate, ventilatory threshold), physical activity with activity monitor, health related quality~     of life will be determined before and after training.~      Abbreviations : FEV1 = forced expiratory volume in 1 sec; VC = vital capacity; TLC = total~     lung capacity; BMI = body mass index.~   "
106656|NCT02171364|"~     Radiofrequency catheter ablation is highly effective in the treatment of patients with~     persistent atrial fibrillation. In order to decrease the recurrence rate after catheter~     ablation, the investigators propose to apply 'virtual' ablation on patient-specific atria by~     simulating 3D atrial computer model. The investigators will test with five different set of~     ablation methods and find successful methods for a specific patient. Then, this result will~     be compared to empirical catheter ablation result by randomly controlled trial.~   "
106657|NCT02171351|"~     Physical activity (PA) is recommended for the treatment of subjects with type 2 diabetes to~     increase insulin sensitivity and improve metabolic control. However, adherence to PA is often~     poor, due to a lack of motivation or due to disabling complications or comorbidities.~     Neuromuscular electrostimulation (NMES) is a physical treatment commonly used to improve~     muscle strength and volume in several situations: after stroke, after limb trauma or during~     chest rehabilitation in deconditioned patients. The investigators have already shown in a~     first pilot study (manuscript in preparation) that NMES improves insulin sensitivity : in the~     study ELECTRODIAB (No. ID-RCB: 2011-A00930-41), the investigators showed a 25% insulin~     sensitivity improvement after a week of daily 25-min bi-quadricipital NMES session, in a~     population of patients with orally-treated type 2 diabetes. Insulin sensitivity increased up~     to 50% in the most deconditioned subjects. Discrepancy between this result and the very low~     energy expenditure measured during sessions suggests that the metabolic effect was not solely~     mediated by muscle contractions. The investigators hypothesize the involvement of~     neurological pathways. Indeed, it is demonstrated that the autonomic nervous system is an~     important regulator of glucose metabolism with pancreatic action, a key role in energy~     metabolism and a complex relationship with insulin resistance. Muscle activity, whether~     static (isometric) or dynamic causes changes in sympathetic nerve activity in healthy~     subjects but its effect in type 2 diabetic subjects is not known. The investigators~     hypothesize that, in type 2 diabetic subjects, the modulation of sympathetic nerve activity~     by NMES could be involved in the improvement of insulin sensitivity. To address this~     question, the investigators propose to assess sympathetic nerve activity with the gold~     standard method of microneurography before and after a single bi-quadricipital NMES session.~     The impact of neuro-electro-stimulation (NES) (a sensitive stimulation under muscular~     threshold) and the impact of voluntary isometric muscle contractions (VC) will also be~     evaluated. These procedures will also be applied in healthy control subjects.~   "
106658|NCT02171338|"~     The purpose of this study is to investigate weather or not the use of a~     procalcitonin(PCT)-based treatment in the daily clinical work could lower the consumption of~     antibiotics in patients with lower respiratory tract infections.~   "
106659|NCT02171325|"~     The purpose of this study is to identify the appropriate dose of irinotecan by dose~     escalation(dose climbing) test. The study would provide rationale for regimen decision in a~     future phase III clinical trial, in which irinotecan combined with cisplatin(IP) will be~     selected as therapeutic drugs.~   "
106676|NCT02171104|"~     This single-institution, phase II study is designed to test the ability to achieve donor~     hematopoietic engraftment while maintaining low rates of transplant-related mortality (TRM)~     using busulfan- and fludarabine-based conditioning regimens with busulfan therapeutic drug~     monitoring (TDM) for patients with various inherited metabolic disorders (IMD) and severe~     osteopetrosis (OP).~   "
106991|NCT02166983|"~     This randomized clinical trial studies cognitive enhancement program in improving cognitive~     function in breast cancer survivors. A cognitive enhancement program may help improve~     cognitive function in breast cancer survivors and may help doctors plan better treatment for~     cognitive decline.~   "
106660|NCT02171312|"~     The iDETECT (Integrated Display Enhanced Testing for Concussion and mild traumatic brain~     injury) system is a novel portable, open access platform that enables immediate and rapid~     assessment of multimodal neurologic function. This study seeks to evaluate the iDETECT~     function testing battery with currently used balance and inner ear assessment methods during~     initial concussion clinic referral. Two groups of participants will be enrolled; a concussion~     related dizziness cohort and control subjects. The investigators will enroll the concussion~     cohort from patients presenting to the Sports Concussion Institute (SCI) with persistent~     dizziness and imbalance symptoms following possible concussion. Healthy control participants~     will be recruited from the local community. iDETECT's ability to identify post concussion~     balance/vestibular disturbances will be compared to an expert concussion assessment. Both~     cohorts will participate in the iDETECT assessment and the clinical assessment.~   "
106661|NCT02171299|"~     Background: Intraoperative wound infiltration with local anaesthetic is commonly used. Apart~     from the obvious immediate action it has been supported that a possible down regulation of~     pain receptors may lead to longer effects. Our aim was to compare the use of local~     anaesthetic versus placebo in order to assess if indeed there is a late beneficial effect.~      Materials and methods: We will conduct a RCT involving 400 consecutive general surgery~     patients randomized in 2 groups: Group A= placebo, Group B= wound infiltration with~     ropivacaine 10%. We will record the preoperative and postoperative pain for the 1st week as~     well as the type and quantity of the analgesia used during the study period.~      Hypothesis : patients who receive intraoperatively wound infiltration with local anaesthetic~     have lower pain during the 1st postoperative week and require less pain killers .~   "
106662|NCT02171286|"~     The BCCA Oncopanel is a clinical assay being developed to determine genotype status of a~     prospectively defined set of genes.~      The purpose of this pilot study is to assess the feasibility and effect on~     clinical-decision-making of the Oncopanel test. Eligible patients are those with advanced~     lung, colorectal, melanoma and GIST cancers and patients with diagnosed malignancies being~     considered for clinical trials.~   "
106663|NCT02171273|"~     The overall objectives of the proposed study are to examine the consequences of chronic~     circadian disruption and chronic sleep restriction on metabolic function in healthy adults.~   "
106664|NCT02171260|"~     This is a Phase 1 study of eribulin mesylate in pediatric patients with recurrent or~     refractory solid tumors (excluding CNS), including lymphomas. Eribulin mesylate will be~     administered intravenously, once per day on Days 1 and 8 of a 21-day cycle. This study aims~     to determine the MTD and/or the RP2D of this regimen in Part A1 (patients greater than or~     equal to 12 months and less than 18 years). Part A2 will enroll infants (greater than 6~     months and less than 12 months) one dose level behind the dose level at which patients in~     Part A1 are enrolling, in order to maximize safety for infant subjects. Additionally, this~     study aims to describe the toxicities and the pharmacokinetics of eribulin mesylate when~     administered to children. In a preliminary manner, the antitumor effect of eribulin mesylate~     will also be described.~   "
106665|NCT02171247|"~     Computed Tomography Angiogram (CTA) scans are performed routinely to look at the vessels in~     the body as an alternative to directly injecting contrast into the vessels and taking~     pictures. Different types of intravenous (into the vein, IV) contrast are available to fill~     the vessels and make them easier to see. The purpose of the study is to determine the best~     type of contrast for this scan.~   "
106666|NCT02171234|"~     The purpose of this study is to investigate the safety and tolerability of multiple dose~     regimens of BIA 2-093 in healthy young male volunteers~   "
106667|NCT02171221|"~     This is a first-in-human, open label, single arm, sequential dose escalation and expansion~     study of oral DFP-11207 in patients with advanced solid tumors.~   "
106668|NCT02171208|"~     The primary objective of this study is to establish the bioequivalence of the test product~     (BG00012 [dimethyl fumarate] supplied by Biogen Idec OSD) to the reference product (BG00012~     supplied by Vifor SA) by comparison of pharmacokinetic (PK) profiles in healthy volunteers.~      The secondary objectives of this study are to determine the safety and tolerability of the~     test product compared to the reference product, to estimate PK parameters of the test product~     and the reference product, and to estimate the intra-subject coefficient of variation (CV%)~     of the referenced product for both area under the plasma concentration curve (AUC) and peak~     plasma concentration (Cmax).~   "
106669|NCT02171195|"~     The purpose of this study is to determine the safety and tolerability of single rising oral~     doses of BIA 2-093 (proposed doses 20mg, 50mg, 100mg, 200mg, 400mg, 600mg, 900mg and 1200mg)~     in groups of 8 healthy male adult volunteers.~   "
106670|NCT02171182|"~     The aim of this study is to monitor the effectiveness and used dosage of the 8% capsaicin~     patch in real-life clinical practice in the treatment of post-operative neuropathic pain.~   "
106671|NCT02171169|"~     The purpose of this retrospective data review is to evaluate the health economic drivers and~     complications of two surgical procedures: transsacral lumbar interbody fusion and~     transforaminal lumbar interbody fusion when used in conjunction with bilateral supplemental~     screw fixation as an adjunct to fusion. Devices used in both systems are cleared for use and~     comply with US regulations and requirements.~   "
106672|NCT02171156|"~     To provide early access and to evaluate the safety and tolerability of nintedanib in patients~     with idiopathic pulmonary fibrosis (IPF).~   "
106673|NCT02171143|"~     The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of~     single, ascending, intravenous (IV) doses of ASP2409 in patients with Rheumatoid Arthritis~     (RA) on methotrexate (MTX) and to evaluate the pharmacodynamics (PD) of ASP2409.~   "
106674|NCT02171130|"~     Up to two hundred (200) adult patients with T1D aged 18 to 75 years will be selected for~     inclusion in the study. The target is to obtain treatment response and user-experience data~     following use of AMG504-1 in treating episodes of hypoglycemia. The population will be~     enriched to include participants who suffer from impaired hypoglycemia awareness.~   "
106675|NCT02171117|"~     Patients enrolled from each center according to confirmed criteria specified in cooperative~     scheme are randomly assigned to standard induction and consolidation chemotherapy with~     microtransplantation （MST-group）or without (CT-group).Compare the remission rate and 2-year~     disease-free survival (DFS) and overall survival(OS) rate of the two groups.~   "
106677|NCT02171091|"~     The purpose of this research study is to determine how cell changes during endotracheal~     intubation and artificial lung ventilation affect lung inflammation.~      Patients will undergo placement of an endotracheal tube (ETT) as standard of care. Tracheal~     (windpipe) lavage will be obtained each day for up to 72 hours. Lung samples or fiberoptic~     (lung) samples will be collected at the same time intervals when possible and if they are~     done as standard of care.~      Blood samples will be obtained simultaneous with the collection of the trachael (windpipe)~     specimens.~   "
106678|NCT02171078|"~     Nearly three million living women have survived breast cancer. Physicians rely on clinical~     practice guidelines to make decisions on follow-up care. Among other things, the goal is to~     monitor for recurrence or side effects of treatment among survivors. It is unclear whether~     these guidelines represent the best approach for any given patient as they do not account for~     differences in disease or patient preferences and may not consider recent advances in imaging~     and treatment options. We seek to develop a new approach to surveillance following breast~     cancer treatment which will be more patient-centered and effective than the existing~     one-size-fits-all approach and will consider individual risk factors.~   "
106679|NCT02171065|"~     The present study has two components, an overall prospective observational study using~     multimodality imaging (PROSPECT II) that will examine the natural history of patients with~     unstable atherosclerotic coronary artery disease with the specific goal to establish the~     utility of low risk intracoronary imaging modalities, Intravascular Ultrasound (IVUS) and~     Near InfraRed Spectroscopy(NIRS), to identify plaques prone to future rupture and clinical~     events. Due to the difficulty of interpreting the IVUS images, this study will be, however,~     using Plaque Burden (PB) ≥65% as the primary threshold defining vulnerable plaques. However,~     sensitivity analyses will be run for patients and lesions with PB≥70%. The randomized~     PROSPECT ABSORB sub-study will examine whether treatment of vulnerable plaques with the~     ABSORB Bioresobable Vascular Scaffold (BVS) plus Guideline Directed Medical Therapy (GDMT)~     safely increases the Minimal Lumean Diameter (MLA) at 25 month compared with GDMTalone.~   "
106680|NCT02171052|"~     To investigate the bioavailability of dabigatran with and without concomitant administration~     of digoxin and the bioavailability of digoxin with and without concomitant administration of~     dabigatran etexilate~   "
106681|NCT02171039|"~     To investigate the bioavailability of dabigatran with and without concomitant administration~     of atorvastatin and the bioavailability of atorvastatin with and without concomitant~     administration of dabigatran etexilate~   "
106682|NCT02171026|"~     Investigation of the bioavailability, safety and tolerability of dabigatran with and without~     concomitant administration of amiodarone and the bioavailability of amiodarone and~     desethylamiodarone after administration of a single dose of amiodarone with and without~     dabigatran~   "
106683|NCT02171013|"~     To establish the bioequivalence of two drug product batches of dabigatran etexilate, one~     batch containing only polymorph I vs. the other batch containing 17% of dabigatran etexilate~     polymorph II in addition to polymorph I~   "
106684|NCT02171000|"~     To investigate safety, pharmacokinetics and pharmacodynamics of BIBR 1048 MS following oral~     administration of multiple doses (150 mg b.i.d., 7 days)~   "
106685|NCT02170987|"~     To investigate if dabigatran has a clinically relevant impact on the cardiac~     electrophysiology that is manifest as prolongation in QT-interval.~   "
106686|NCT02170974|"~     Investigation of the relative bioavailability of BIBR 953 ZW after administration of 150 mg~     BIBR 1048 polymorph II versus BIBR 953 ZW after administration of 150 mg BIBR 1048 polymorph~     I in HPMC capsules~   "
106687|NCT02170961|"~     this study aim to investigate the:~        -  association of RAAS polymorphisms and AHF~        -  association of MMP 3 and 12 polymorphisms and AHF~   "
106688|NCT02170948|"~     Forefoot surgeries involve a relatively short operation usually completed in 1 - 1½ hours,~     with patients generally being allowed to go home on the same day. Despite this, post-surgery~     pain is often severe and a delay in the discharge of patients due to difficulty with pain~     control after the surgery is common.~      Performing nerve blocks in association with sedation is the preferred way to provide pain~     relief and offers important benefits for foot surgeries. With nerve blocks, the requirement~     for oral painkillers and their associated side effects is reduced. Increasing the duration of~     local anesthetic action is helpful as it increases the time of pain relief, allowing for a~     smoother transition to oral pain medications, earlier discharge, and faster recovery.~      Recently, Precedex has been considered for its usefulness in prolonging the pain relief~     produced by nerve blocks. The identified benefits of this particular use include reducing~     post-surgical pain medications requirements, reducing the incidence of nausea and vomiting,~     reducing the incidence of sedation from such medication, and diminishing the incidence of~     respiratory depression (inadequate breathing). Two small studies have also shown that adding~     dexmedetomidine to nerve block solution results in prolonging pain relief.~      The purpose of the study is to examine several doses of dexmedetomidine combined with local~     anesthetic drugs and determine the best combination for prolonging pain relief, while~     minimizing potential side effects.~   "
106689|NCT02170935|"~     To determine the PK profile of a single dose 150 mg BIBR 1048, oral capsule, administered 1-3~     hours post surgery in hip replacement patients.~   "
106690|NCT02170922|"~     Comparative pharmacokinetics of BIBR 1048 MS solution and tablet with or without food~   "
106691|NCT02170909|"~     Study to investigate and compare safety, pharmacokinetics and pharmacodynamics of BIBR 1048~     MS following oral administration of single (150 mg, 220 mg and 300 mg) and multiple (150 mg~     and 220 mg q.d. and 150 mg b.i.d.) rising doses in healthy male subjects of Japanese and~     Caucasian origin.~   "
106692|NCT02170896|"~     To assess the amount of BIBR 953 ZW in urine of 50 mg of BIBR 1048 bid over three days each~     administered as four experimental capsule formulations relative to drinking solution with and~     without coadministration of 40 mg pantoprazole.~   "
106693|NCT02170883|"~     Between 8% and 12% of Canadians suffer from asthma. Although there are effective and~     inexpensive treatments, adherence to asthma treatment is amongst the lowest for all chronic~     diseases.The purpose of this study is to determine whether enhancing the role of community~     pharmacists in asthma management using interactive short messaging service (SMS) with asthma~     patients is a cost-effective model that will improve adherence to inhaled corticosteroid~     medications compared to usual care.~   "
106694|NCT02170870|"~     The purpose of this study is to understand why people with indigestion have gastrointestinal~     symptoms and in particular to understand whether symptoms are related to increased~     sensitivity to nutrients in the small intestine and to a hormone (GLP1) which is normally~     released from the small intestine in response to nutrients. We propose to study the~     contribution of GLP1 to intestinal sensitivity with a drug (exendin 9-39) that blocks the~     effects of GLP1.~   "
106695|NCT02170857|"~     The aim of this study is to evaluate the effect of hyaluronic acid in the surgical treatment~     of periodontal pockets in people with gum disease.~      This research consists of clinical and radiographic studies. Participants should have~     symmetric periodontal pockets in the upper or lower jaw.~      Participants will be treated surgically using hyaluronic acid on one side of the jaw.~      Clinical indexes and radiographic cone-beam computed tomographic (CBCT) images will be taken~     for each participant before surgical treatment and 12 months after surgical treatment.~   "
106696|NCT02170844|"~     To investigate and compare safety, pharmacokinetics and pharmacodynamics of BIBR 1048 MS~     following oral administration of single rising doses from 50 mg to 350 mg in healthy male~     subjects of Japanese and Caucasian origin. This was the first administration of this~     substance to subjects of Japanese origin.~   "
106697|NCT02170831|"~     To assess safety, pharmacokinetics and the effect of BIBR 1048 MS on coagulation parameters.~   "
106698|NCT02170818|"~     Importance Team members speaking-up by raising concerns about inappropriate or unsafe actions~     of others within the team can have direct, immediate, and preventive effect on adverse~     outcomes. However, little is known about the hurdles and enablers of this behavior in~     healthcare, especially within the operating room setting.~      Objective~      1. Determine if an educational workshop would improve speaking-up behaviors of practicing~     anesthesiologists when presented with realistically-simulated clinical situations. 2.Describe~     speaking-up behaviors addressed to a surgeon, a nurse, and a colleague. 3. Identify the~     self-reported hurdles and enablers for speaking-up in those situations encountered.~      Design Randomized controlled experiment of an educational workshop intervention on~     communication behaviors in a simulated case. Qualitative analysis of debriefing conversations~     following the simulated case.~      Setting Established academic simulation center~      Participants Seventy-one practicing anesthesiologists from four academic medical centers and~     one community hospital~      Intervention Fifty minute educational workshop on speaking-up that included rationale,~     conversational techniques, a rubric for speaking-up, and role-play.~   "
106699|NCT02170805|"~     The pharmacokinetics of 50 mg BIBR 1048 administered as two newly developed capsule~     formulation using melt extrusion technology was assessed in two separate, single dose, 3-way~     crossover, open design, randomised studies. The 3-way crossover treatments included~     administration of the tartaric acid solution of 50 mg BIBR 1048, the capsule formulation A or~     B and administration of the capsules with coadministration of pantoprazole.~   "
106700|NCT02170792|"~     To assess the extent of absorption of 12.5, 50 and 200 mg of BIBR 1048 MS with and without~     coadministration of 150 mg ranitidine.~   "
106701|NCT02170779|"~     This is a study to determine the impact of education and specific lower extremity stretches~     for MS-related spasticity. The study will evaluate the acceptance and efficacy of education~     and stretching using a randomized controlled pilot trial.~   "
106702|NCT02170766|"~     To assess the extend of absorption of 12.5, 25, 50 and 100 mg of BIBR 1048 free base with and~     without coadministration of 40 mg pantoprazole.~   "
106703|NCT02170753|"~     Purpose: The primary purpose of this study is to determine whether or not the addition of~     thoracic, pelvic, and hip manual therapy to a standard physical therapy (PT) approach~     consisting of motor control exercises and lumbar spine manual therapy is better than standard~     PT alone at improving thoracolumbar spine range of motion (ROM), hip ROM, pain intensity,~     disability level, and perceived change in patients with chronic low back pain (CLBP) and~     movement coordination impairments.~      Hypothesis: In a CLBP subgroup with movement coordination impairments, participants receiving~     thoracic, pelvic, and hip manual therapy with standard PT will be superior to participants~     receiving standard PT alone at improving thoracolumbar spine ROM, hip ROM, pain intensity,~     physical disability level, and perceived change at two, four, and 12 weeks after initiating~     treatment.~   "
106704|NCT02170740|"~     To assess safety, pharmacokinetics and the effect of BIBR 1048 MS on coagulation parameters~     in healthy volunteer subjects.~   "
106705|NCT02170727|"~     To demonstrate the effectiveness of Daclatasvir (DCV) 3 Direct Acting Antivirals (DAA) fixed~     dose combination in Genotype 1 Chronic Hepatitis C subjects.~   "
106706|NCT02170714|"~     Background and aims: Acute severe ulcerative colitis (ASC) is a potentially life-threatening~     event. Poor pediatric data are available about the success rates of Infliximab (IFX) as a~     second line therapy. This study was performed in consecutively observed pediatric patients~     with ASC, treated according to the 2011 European Crohn's colitis Organization (ECCO)-~     European Society for Pediatric Gastroenterology, Hepatology and nutrition (ESPGHAN)~     guidelines on pediatric ASC¹ and aim to assess the long-term efficacy of IFX and clinical~     predictors of poor outcome.~      Methods: Children hospitalized for an episode of ASC, defined as a Pediatric Ulcerative~     Colitis Activity Index (PUCAI) of at least 65 points, were enrolled. Clinical assessment~     through PUCAI and laboratory data (Erythrocyte Sedimentation Rate, C-Reactive Protein,~     hemoglobin, albumin, hematocrit, ferritin) was recorded at admission and at day 3 and 5. All~     patients were treated according to the above mentioned guidelines for ASC and received~     intravenous (iv) corticosteroids (CS) as first-line therapy. IFX was administered as~     second-line therapy in CS-refractory patients. In a 2-year follow up the overall colectomy~     rate and the efficacy of IFX in avoiding colectomy were evaluated.~   "
106707|NCT02170701|"~     -  To determine the therapeutic window of BIBR 1048 in order to select doses for further~          studies in the development plan.~        -  Twice daily regimen will be tested for most dose levels and once daily administration~          will also be evaluated when appropriate.~   "
106772|NCT02169856|"~     In our study the investigators want to evaluate the effects of EFTs (emotional freedom~     techniques) for reducing incidence of PONV (Postoperative nausea and vomiting). The effects~     of EFTs have been quiet evident on many aspects if the incidence of PONV is reduced then it~     will be much valuable adjunct to postoperative management of the patients.~      Our hypothesis was Emotional freedom techniques are very useful to reduce the incidence of~     postoperative nausea and vomiting after laparoscopic cholecystectomy.~   "
106708|NCT02170688|"~     There are several different methods that can be used to determine the dose of iodinated~     contrast material for a CT scan. These include a standard fixed dose, a dose based on total~     body weight, a dose based on body mass index, a dose based on lean body weight, and a dose~     based on estimated lean body weight. The fixed dose method uses a predetermined amount of~     contrast material for all patients having a CT scan of the abdomen regardless of size. This~     is the standard procedure currently used at Duke. The other methods use the patient's weight,~     either the total body weight or lean body weight, to determine the amount of contrast~     necessary for the CT exam. For this study, the investigators will use the fixed dose, total~     body weight, the lean body weight, and estimated lean body weight methods. The purpose of~     this study is to evaluate these five methods of determining the IV contrast volume and which~     may be best for abdominal CT scanning.~   "
106709|NCT02170675|"~     To investigate whether and to what extent the P-glycoprotein (P-gp) inhibitor ketoconazole~     affects plasma exposure of dabigatran.~   "
106710|NCT02170662|"~     The purpose of this study is to determine the effect of bimatoprost solution on scalp hair~     growth. Bimatoprost 0.03% ophthalmic solution is currently approved by the FDA for treatment~     of glaucoma (Lumigan™) and for thickening of thin eyelashes (Latisse™). Bimatoprost 0.03% is~     not approved for the treatment of scalp hair loss and its use in this study is considered~     investigational which means it is still being tested in research studies.~      Thirty-three subjects were consented and screened, 9 entered and 9 completed the study.~   "
106711|NCT02170649|"~     The purpose of this study is to investigate the effect of food on the pharmacokinetics of a~     single 800 mg oral dose of BIA 2-093 in healthy volunteers.~   "
106712|NCT02170636|"~     Study to assess the amount of BIBR 953 ZW in urine after administration of 50 mg BIBR 1048~     bid over three days each administered as four experimental formulations relative to drinking~     solution with and without coadministration of 40 mg Pantoprazole~   "
106713|NCT02170623|"~     Study to assess the amount of BIBR 953 ZW in urine and concentrations in plasma after~     administration of 50 mg of BIBR 1048 bid over three days each administered as two~     experimental formulations relative to drinking solution with and without coadministration of~     40 mg Pantoprazole.~   "
106714|NCT02170610|"~     To assess the extent of absorption of 150 mg of BIBR 1048 administered as capsule formulation~     with and without coadministration of 40 mg Pantoprazole and to assess the effect of food on~     rate and extent of absorption.~   "
106715|NCT02170597|"~     Study to investigate the relative bioavailability of BIBR 953 ZW after administration of a~     150 mg BIBR 1048 HPMC (hydroxypropylmethylcellulose) capsule versus BIBR 953 ZW after~     administration of a 150 mg BIBR 1048 gelatine capsule, and to investigate the relative~     bioavailability of BIBR 953 ZW given as BIBR 1048 MS HPMC capsule with food versus without~     food.~   "
106716|NCT02170584|"~     Two substudies to assess (1) the tolerability of BIBR 953 ZW intravenous infusion at 0.1, 1~     and 5 mg BIBR 953 ZW and (2) the absolute bioavailability of 100mg BIBR 1048 administered as~     'acid free' tablet formulation (TF1) and (3) the bioavailability of the 100 mg tablet of BIBR~     1048 relative to the tartaric acid solution of 100 mg dose strength and (4) the absolute~     bioavailability of the 100 mg tartaric acid solution of BIBR 1048 MS.~   "
106717|NCT02170571|"~     Assessment of the effect of moderate liver impairment (Child-Pugh classification B) on the~     pharmacokinetics and pharmacodynamics of dabigatran after oral administration of dabigatran~     etexilate. Determination of safety and tolerability of dabigatran upon administration to~     hepatically impaired patients and healthy subjects (matched pairs)~   "
106718|NCT02170558|"~     To determine if the subject metal reduction software helps to better visualize bone~     interphase and fusion reliability. Assess whether the appropriate procedural modification~     facilitates clearer images when implanted with a trabecular metal spinal implant~   "
106719|NCT02170545|"~     Displaced, multi-part intracapsular, proximal humerus fractures represent a major challenge~     for patients and orthopedic surgeons. Proximal humerus fractures represent the third most~     common fracture after hip and distal radius fractures, and more than 20% of these fractures~     meet operative indications. Unfortunately, one of the major complications of these fractures~     is the development of avascular necrosis (AVN), or death of the bone as a result of the loss~     of blood supply to it. Currently, the ability to predict AVN is limited. The purpose of this~     study is to determine if computed tomography imaging can identify a quantifiable predictor of~     AVN following this type of humeral fracture.~   "
106720|NCT02170532|"~     Dr. MacIntyre and his colleagues are studying inhaled medications in asthma. There are two~     new medications that have been approved by the United States Food and Drug Administration~     (FDA): levalbuterol and formoterol. Both of these drugs are similar to standard asthma~     bronchodilator drugs but offer theoretical advantages in terms of fewer side effects. There~     are also newer devices to deliver these medications into the lungs: breath actuated~     nebulizers (BANs) and non-static chambers (Aerochamber-max) that can be used with metered~     dose inhalers (MDIs or puffers). The purpose of this study is to deliver these new~     medications using several different devices and measuring lung function, heart rate, and~     sensations of breathlessness.~   "
106721|NCT02170519|"~     Acute secondary pulmonary hypertension (PH) often leads to dysfunction of the right ventricle~     (RV) and can be a significant cause of patient morbidity and mortality. Selective pulmonary~     vasodilation with inhaled nitric oxide (INO) has become the treatment of choice for this~     condition. The evidence supporting INO safety and efficacy under these circumstances is~     sparse, however, and is largely extrapolated from the use of INO in neonatal pulmonary~     hypertension. Moreover, the high cost and potential toxicity of INO makes the therapy far~     from ideal. Emerging evidence suggests that inhaled aerosolized prostacyclins such as~     iloprost may be a favorable alternative therapy.~   "
106749|NCT02170155|"~     Understanding the onset and progression of spinal cord disorders is an important aim in~     clinical neurology. An early diagnosis with consequent therapy might prevent the progression~     of disability. Therefore, we aim to determine structural and dynamic changes in the~     microstructure of the spinal cord and CSF, and to explore the relationships between the MRI~     parameters, clinical disability, and electrophysiology.~      In some patients with cervical stenosis, the spinal and arterial pressure will be measured~     for 7 days after surgery to find out if functional limitations and structural changes~     correlate with the spinal pressure and the spinal perfusion when the spinal cord is damaged.~   "
106722|NCT02170506|"~     Swallowing is a complex phenomenon that allows oral feeding while protecting the airway. It~     involves many brain areas, including primary motor and sensory areas. Its dysfunction, called~     oropharyngeal dysphagia is present in approximately 60% of patients with a stroke. In this~     case, it is conventionally translated by a swallow response time delay of the swallowing~     reflex.~      Pathophysiology of dysphagia is explained by impairment of the dominant swallowing, function~     that representation center is bi-hemispheric but asymmetric (Hamdy, 1997). Half of patients~     with a stroke supra-tentoriel with oropharyngeal dysphagia (about 55 % of strokes) regain~     normal swallowing in a few weeks ( Barer, 1989). Mechanisms that determine the recovery~     appear to be related to a reorganization of the motor cortex intact. Patients who retain~     disorders are those who have not cortical reorganization.~      With this in mind a team used different methods known to modulate brain plasticity, which~     electrotherapy with an application endo- pharyngeal sensory threshold. This stimulation~     increases the excitability of the cortico- bulbar reflex, which improves swallowing function~     in the clinical application.~      The hypothesis of this work is that the transcutaneous electrical stimulation applied~     submental, noninvasive technique, would also have an impact on cortical plasticity may~     explain the improved coordination of swallowing observed in earlier studies (Verin , 2011) (~     Gallas , 2010).~   "
106723|NCT02170493|"~     The purpose of this study is to use a novel load monitoring technology to correlate limb~     loading to OTA type 42IIIB and IIIC tibial fracture outcomes. This study will be the first to~     collect continuous limb loading data and will provide the first objective insight into how~     limb loading directs fracture healing. To meet this purpose, two specific aims have been~     developed.~      Specific Aim 1: Preclinical validation of a load-monitoring insole~      The Hitchcock laboratory has overcome the greatest technical hurdle for continuous limb load~     monitoring: development of load sensor technology that is affordable, accurate and capable of~     monitoring for over four weeks. To develop this sensor technology into a load-monitoring~     insole, the Hitchcock lab will incorporate consumer type electronics into the design,~     including a microprocessor, battery, and data storage media.~      Following construction of a functional load-monitoring insole, a pilot human study with~     orthopaedic trauma patients from the University of Utah (N=20) will be conducted to identify~     modes of device failure, improve device interfacing and develop data handling protocols and~     software for the clinical arm of the proposed study.~      Specific Aim 2: Conduct a prospective, direct observational cohort study.~      Thirty (30) open tibial fracture patients will be recruited at two centers: University of~     Utah (N=15) and William Beaumont Army Medical Center (N=15). Participants will wear a walking~     boot instrumented with the load-monitoring insole that will continuously record limb loading~     and serve as a step counter. X-rays collected at standard-of-care follow-up visits will be~     used by Drs. Kubiak and Orr to subjectively evaluate fracture healing. A questionnaire~     regarding subjective perception of patient compliance will be collected at the first and last~     follow-up visits. Data collected from the insole sensor will be correlated to objective~     measures of fracture healing and subjective measures of patient compliance to determine the~     effect of patient limb loading on injury outcome. The Hitchcock laboratory will develop~     software to process and summarize data from the load monitoring insole and continually~     improve human interfacing factors of the load monitoring insole based off of feedback from~     the clinical team and study participants.~   "
106724|NCT02170480|"~     It has been the investigators observation that large diameter traction pins cause more~     postoperative knee pain than smaller traction pins. To the investigators knowledge, no study~     to date has identified knee pain as a consequence of traction pin placement. Furthermore, no~     study has identified whether pin size has an effect on the incidence of postoperative knee~     pain. The goal of the present study is to establish whether use of temporary skeletal~     traction is associated with subsequent knee pain and to determine whether traction pin size~     influences the incidence and/or magnitude of knee pain.~      Objective #1:~      Determine whether pin size influences the incidence and/or severity of postoperative knee~     pain in patients who undergo temporary skeletal traction.~      Hypothesis:~      Larger traction pins are associated with an increase in both the incidence and severity of~     postoperative knee pain.~      Objective#2:~      Determine whether pin size affects musculoskeletal function in the postoperative period.~      Hypothesis:~      There is no difference between small and large traction pins in postoperative musculoskeletal~     function.~   "
106725|NCT02170467|"~     In healthy humans, the intestinal mucosa acts as an absorption organ and a defensive barrier~     preventing the passage of toxic substances from the intestinal lumen to the blood stream.~     Malnutrition and absence of exogenous luminal nutrients in the gastrointestinal tract~     profoundly affect small bowel morphology and physiology. Many reports have described~     alterations of ion and nutrient transport, mucosal atrophy and modifications in the~     intestinal permeability to macromolecules in cases of prolonged intestinal rest, as in severe~     starvation. These changes may dampen both the absorptive and the barrier functions of~     intestinal mucosa.~      The assessment of intestinal permeability, by measuring the urinary excretion of substances~     that are not metabolised by human tissues and passively cross the intestinal epithelium, is a~     reliable and non invasive method to investigate the anatomo-functional integrity of the~     intestinal mucosa. Previous studies have shown an increase of permeability in malnourished~     humans . The increase of may also increase the risk for inappropriate passage of food~     antigens and other noxious substances across the mucosal barrier. To this regard, the~     enhanced susceptibility of malnourished subjects to systemic infections and postoperative~     sepsis has long been recognised.~      Anorexia nervosa is a psychiatric disorder characterised by abnormal eating behaviours aiming~     to decrease body weight. Typically, women with anorexia nervosa restrict food ingestion up to~     severe starvation. These behaviours usually lead to malnutrition and a more or less prolonged~     absence of luminal nutrients in the gastrointestinal tract. Therefore, alterations in the~     integrity and functioning of intestinal mucosa are likely to occur in this condition. There~     is no information on intestinal permeability in patients with eating disorders. We~     hypothesised that, as it occurs in simple starvation and malnutrition, intestinal~     permeability should be increased in fasted undernourished people with anorexia nervosa and~     decrease after re feeding. Therefore, in the present study, we explored intestinal~     permeability of 23 subjects with anorexia nervosa by means of the lactulose-mannitol test and~     urinary sucralose excretion and compare them to 46 controls.~      Moreover, auto-antibodies (α-MSH ) have been found in patients with anorexia nervosa. The~     origin of these auto-antibodies is still unknown , but some studies suggested a digestive~     origin. Moreover, modifications of intestinal flora have been described in patients with~     anorexia nervosa. Actually, a study of the intestinal barrier of patients with anorexia~     nervosa is necessary. In this study, a comparaison of intestinal permeability and~     autoantibodies (α-MSH) rate is proposed before and after re-feeding in patients with anorexia~     nervosa.~   "
106726|NCT02170454|"~     The aim of this study is to test the hypothesis that rTMS on the dominant swallowing~     hemisphere is able to modify swallowing coordination.~   "
106727|NCT02170441|"~     The goal of this study is to evaluate time to diagnosis for three assays (line probe,~     pyrosequencing, and Microscopic Observation Drug Susceptibility Assay [MODS]) to detect~     resistance to first and second-line anti-tuberculosis (TB) drugs in Mycobacterium~     tuberculosis (Mtb) strains in 7 days or less, allowing for rapid diagnosis of extensively~     drug-resistant TB (XDR-TB).~   "
106728|NCT02170428|"~     The overall objective with the study was to contribute to the scientific basis for dietary~     and life strategies, policies and dietary guidelines to infants and young children in Denmark~     and with special focus on prevention of obesity and diet related chronic diseases such as~     type 2 diabetes, ischemic heart disease and osteoporosis.~   "
106762|NCT02169986|"~     Forgetting is usually listed as the most important cause of low adherence among patients.~     Most studies to date have looked at the adherence of adults or adolescent population. No~     studies have been done looking specifically at adherence to topical treatment by~     parents/caregivers of young children. Our project will try to replicate the same results~     among the parents/caregivers responsible for children ten years and under. The population in~     this study will be the parents/caregivers of children 10 and under with atopic dermatitis and~     the intervention will be the effect of electronic reminders in adherence rates for the use of~     a moisturizer which is recognized as part of the standard of care in the treatment of atopic~     dermatitis.~   "
106729|NCT02170415|"~     Numerous surveys have shown that following breast surgery, longterm pain affects around half~     of patients. Given that 1 in 9 women will get breast cancer and that surgery is the~     cornerstone of treatment, persistent pain represents a major challenge. In addition to the~     suffering chronic pain causes to individual patients, the investigators know that it places a~     substantial burden on families and carers, and that patients with pain represent an excessive~     demand on healthcare resources.~      This research will evaluate the impact of introducing a proactive, integrated care plan for~     patients having breast surgery. It will assess the effect of the care plan on reducing the~     number of patients with pain at 3 and 12 months after their procedure.~      The personalised plan involves numerous evidence based steps linked by a single unifying~     description aimed at controlling pain, before, during and after the procedure, in hospital~     and at home.~      Patients at risk of developing pain will be identified prior to the procedure and randomly~     allocated to follow either the personalised care plan or to receive 'usual' care. In the~     personalised care plan group, participants will get information about chronic pain, be~     screened for pain and offered immediate treatment. During their procedure both the surgeon~     and the anaesthetist will offer treatments such as nerve numbing procedures that reduce the~     likelihood of experiencing pain.~      After their procedure, patients will be again screened for pain and further treatment~     instigated. Physiotherapists and other allied health professionals such as psychologists will~     also be involved as appropriate. A package of care for pain will then be passed on to the~     patients' GP, in the form of a written pain management plan, for ongoing care which will be~     linked to the hospital. Patients from both groups will be followed up for a year at regular~     intervals.~   "
106730|NCT02170402|"~     The purpose of this study is to assess efficacy, safety and pharmacokinetics of ADVATE in the~     treatment and prevention of bleeding episodes (BEs)~   "
106731|NCT02170389|"~     This pilot clinical trial studies vaccine therapy before surgery in treating patients with~     kidney cancer that has not spread to nearby lymph nodes or to other parts of the body.~     Vaccines made from a person's tumor cells and white blood cells may help the body build an~     effective immune response to kill tumor cells when they are infused back into the body.~   "
106732|NCT02170376|"~     The purpose of this study is to determine the effect of repeated dosing of once-daily 25, 50~     and 75 mg opicapone (OPC, development code BIA 9-1067) on the levodopa pharmacokinetics (PK),~     in comparison to placebo and 200 mg entacapone (ENT).~   "
106733|NCT02170363|"~     The purpose of this clinical investigation is to evaluate the performance and safety of the~     HeartMate 3 Left Ventricular Assist System (HM3 LVAS) To support obtaining CE Mark for the~     HM3 LVAS in Europe, a multi-center clinical study will be conducted in multiple countries.~     The clinical study will be conducted in compliance with the Declaration of Helsinki, ICH/GCP~     and EN ISO 14155:2011 Requirements for Clinical Investigations and in accordance with~     country-specific requirements, under one clinical study protocol.~      This study will evaluate the performance of the HM3 LVAS, side effects and undesirable~     conditions within acceptable risks and weigh them against the intended performance of HM3~     LVAS in accordance with Essential Requirements 2, 5 and 16 of the Active Implantable Medical~     Device Directive 90/385/EEC (AIMDD).~   "
106734|NCT02170350|"~     This pilot clinical trial studies how well brief mindful mediation practice works in~     improving quality of life in patients with cancer undergoing radiation therapy. Brief mindful~     mediation practice may improve the well-being and quality of life of patients with cancer who~     are undergoing radiation therapy by increasing levels of mindfulness and reducing stress,~     anxiety/depression, and fatigue.~   "
106735|NCT02170337|"~     A randomized, double-blind, ascending multiple dose study in healthy volunteers and subjects~     with chronic rhinosinusitis with nasal polyps~   "
106736|NCT02170324|"~     Adipose tissues, which include white adipose tissue (WAT) and brown adipose tissue (BAT),~     play an essential role in regulating whole-body energy homeostasis. Excess expansion of WAT~     due to positive energy balance and defects in thermogenic gene expression in BAT are~     associated with obesity and various metabolic diseases. Until 2009 the question of whether~     adult humans had BAT and whether it could conceivably contribute to whole body energy usage~     in a meaningful way was a matter of vigorous debate. The publication of three apppers in the~     New England Journal of Medicine that demonstrated adult humans do have BAT, that it can be~     activated, and that this activation appears to be defective in obesity reframed the debate,~     and revived interest in BAT physiology. Recent studies also reveal the presence of a subset~     of cells in WAT that could be induced by environmental or hormonal factors to become~     ''brown-like'' cells, and this ''beigeing'' process has been suggested to have strong~     antiobesity and antidiabetic benefits.~      The extrapancreatic actions of glucagon-like peptide-1 (GLP-1) on endothelial cells and the~     liver have been reported. Additionally, effects of GLP-1 on adipose tissue have been~     described. Studies performed in isolated adipocytes have demonstrated that GLP-1 has the~     ability to induce both lipogenic and lipolytic mechanisms in white adipose tissue (WAT) .~     More recent study showed that GLP-1 agonism stimulates brown adipose tissue thermogenesis and~     browning through hypothalamic AMP-activated protein kinase (AMPK) in animal. However, there~     is no data clearly show that GLP-1 agonism stimulates browning of subcutaneous white adipose~     tissue (SWAT) in human obesity.~   "
106737|NCT02170311|"~     The safety, tolerability, pharmacokinetics and pharmacodynamics of Z-213 will be investigated~     in patients with iron-deficiency anemia after administration of a single dose (100 mg, 500~     mg, 800 mg or 1,000 mg iron).~   "
106738|NCT02170298|"~     The purpose of this study is to identify the effects of lisdexamfetamine (LDX) on the neural~     and behavioral subcomponents of self-control, that is cognitive control and reward~     functioning, in adolescents and young adults with attention-deficit/hyperactivity disorder.~      The investigators hypothesize that LDX is associated with 1a) decreased task-independent~     locus coeruleus (LC) activity; 1b) increased task-related activity in LC and the cognitive~     control network; 2) increased LC connectivity with the cognitive control network and 3)~     improved task performance and self-control. The investigators will test their hypotheses on~     fMRI data with linear contrasts of voxel-wise maps of parameter estimates (in both univariate~     and connectivity analyses).~      The investigators will also assess change in brain activity with the LDX in the LC and~     ventral tegmental areas (VTA) as we hypothesize that they are altered in ADHD and related to~     cognitive control and self-control dysfunction in ADHD.~      The investigators will use a repeated-measures, between-subject design to compare the effects~     of oral once daily LDX in a double-blind placebo-controlled randomized trial (RCT) on neural~     (fMRI) and behavioral correlates of cognitive control via a working memory and a reward -~     delay discounting task in adolescents and young adults.~      A new condition has been added which will use a within-subject comparison, cross-over design~     between a single dose of LDX versus a single dose of placebo.~   "
107339|NCT02162407|"~     This study is conducted in Europe. The aim of this study is to estimate the relationship~     between pharmacodynamic and interstitial pharmacokinetic steady state following intravenous~     (i.v.) administration of insulin detemir and human soluble insulin.~   "
106739|NCT02170285|"~     The purpose of this study is to test tDCS (transcranial direct current stimulation), a type~     of non-invasive brain stimulation, to determine whether it can improve motor function in~     children with perinatal stroke and hemiparesis. Children 6-18 years with imaging-confirmed~     perinatal stroke and functional motor impairment will be recruited. Children will be~     randomized (1:1) to receive sham or tDCS (20 minutes daily) during daily intensive,~     goal-directed motor learning therapy (90 minutes). Motor outcomes will be repeated at~     baseline, 1 week, and 2 months.~      Aim 1: Establish the ability of tDCS to safely enhance motor learning in children with~     perinatal stroke.~      Hypothesis 1: tDCS is safe and well tolerated in children.~      Hypothesis 2: Contralesional, cathodal tDCS increases motor functional gains measured by AHA~     at 2 months in children with perinatal stroke.~   "
106740|NCT02170272|"~     This pilot clinical trial studies a home-based lymphedema care program in improving~     lymphedema self-care in head and neck cancer survivors. A home-based lymphedema care program~     may help head and neck cancer survivors manage their lymphedema and improve their well-being~     and quality of life.~   "
106741|NCT02170259|"~     Introduction. Tension-type headache is a highly prevalent disorder with a significant~     socio-economic impact, affecting psychological aspects. This study aims to assess aspects~     pertaining to anxiety, depression, headache frequency and pain intensity.~      Subjects and methods. A clinical trial was conducted on 84 participants suffering from~     tension-type headache, divided into 4 groups, the mean age being 39.76 years (SD 11.38). The~     first group received suboccipital soft tissue treatment (ST); the second group was treated~     with articulatory technique (AT); the third group was applied a combination of both~     techniques (ST and AT) and a forth group which served as control group. Treatment sessions~     were administered during four weeks, with a post-treatment assessment, and follow-up after~     one month. The investigators conducted Repeated measures Analysis of Covariance (RM-MANCOVA)~     to evaluate the effect of treatment on between and within-subject conditions and their~     interaction on reported depression, anxiety, and headache pain frequency and intensity.~   "
106742|NCT02170246|"~     This research project will study whether the drug telmisartan administered in conjunction~     with antiretroviral therapy (ART) will help reduce nervous system infection with HIV. The~     investigators are studying the effect of this treatment in people who have contracted HIV~     infection within the past three weeks, and thus have a form of HIV called acute HIV~     infection. The investigators will measure biological markers of immune activation in the~     blood and cerebrospinal fluid to see if telmisartan may reduce the spread of HIV reservoirs~     in affected patients.~   "
106743|NCT02170233|"~     The study aim is to examine point-of-care ultrasound findings, reliability, and ease of~     performance in association with fluid responsiveness for patients with severe sepsis and~     septic shock. The investigators propose a prospective observational research study of~     patients presenting to one of three Yale New Haven Hospital emergency departments, York~     Street Campus, St. Raphael's Campus, and Shoreline Medical Center who meet criteria for~     sepsis, severe sepsis or septic shock during their emergency department visit.~   "
106744|NCT02170220|"~     The purpose of this study is to evaluate the pharmacokinetics of vortioxetine and its~     metabolites Lu AA34443 and Lu AA39835 following a single oral dose administration of~     vortioxetine 5 mg in participants with severe hepatic impairment compared to healthy~     participants.~   "
106745|NCT02170207|"~     The purpose of this survey is to evaluate the safety (that is, frequency of adverse events)~     and efficacy (that is, hemostatic effect, rate of rebleeding after confirmation of~     hemostasis) of administration of lansoprazole intravenous 30 milligram (mg) (Takepron~     Intravenous 30 mg ) to a large number of participants with acute stress ulcer or acute~     gastric mucosal lesion in daily medical practice.~   "
106746|NCT02170194|"~     There is no question that combat and domestic attacks can be stressful, and can have effects~     that last for months or even years, including reliving some of the events through nightmares~     or flashbacks, wanting to avoid anything that is a reminder of combat or domestic attack such~     as movies or the nightly news, or being jumpy and concerned about security. When someone has~     a lot of these symptoms they might be told they have PTSD, but even when that person doesn't~     have the full condition, just having some symptoms can affect their ability to function at~     the highest level at home, work, or in social settings, and puts you at greater risk for~     developing full PTSD. While someone who went through a significant stressful event might not~     need a long course of therapy if they don't have full PTSD, the investigator of this study~     thinks that working with them from a distance through their smart phone over time may~     decrease their symptoms, help them feel better, and prevent full PTSD. Thus the purpose of~     this study is to assess how a brief, relatively simple resiliency enhancement strategy,~     provided mostly through smart phones, affects someone with stress-related symptoms.~   "
106747|NCT02170181|"~     This prospective protocol will enroll patients with pathologically confirmed solid~     malignancies who receive stereotactic body radiation therapy (SBRT) for oligometastases, for~     consolidation after systemic therapy, prior to systemic therapy for the purposes of~     debulking, or in the re-irradiation setting. Increasing use of SBRT off of clinical trials in~     patients with malignancies of all histologies is being utilized in these settings. However,~     individualized outcomes and characteristics of treatments are not prospectively followed and~     not well documented. By instituting a registry of patients receiving SBRT in these settings~     it will be possible to determine trends in patterns of care and outcomes for refinement and~     justification of this treatment.~   "
106748|NCT02170168|"~     The overall aim of this project is to deliver better health care services through improved~     coordination of cancer care within specialist care (at the local hospital Orkdal Hospital)~     and community care (13 municipalities in the Orkdal region, Norway), and between these two~     levels in the health care system. The Orkdal model is developed and will be implemented and~     evaluated within cancer care. Cancer patients living in one of the 12 municipalities~     participating in the formal collaboration Samhandlingsenheten i Orkdalsregionen (SIO), or~     the municipality of Oppdal, having metastatic and/or loco-regional disease will be included~     in the study. Carers and health care providers will be included as well. Results from this~     project will be transferable to other parts of Norway and/or to other countries as well as to~     patients with other diagnoses causing complex conditions, such as chronic heart-, lung- and~     neurological disease.~   "
122041|NCT01970059|"~     The aim of present study is to evaluate the efficacy and safety of Extended-Release~     Carvedilol Sulfate versus in Patients With Mild or Moderate Primary Hypertension~   "
106750|NCT02170142|"~     The major goal of this project is to characterize the structural and functional development~     of cortical plate and white matter of the human neonatal brain from the equivalent 30~     gestational weeks to 45 gestational weeks. The project is sponsored by niH R01MH092535.~     Furthermore, it is related to the blue print project of transcriptome atlas (niH RC2MH089921)~     with at least 36 million funding also sponsored by niH.~      Revealing detailed anatomy at different equivalent gestational ages of human neonatal brain~     not only aids in understanding this highly ordered process, but also provides clues to detect~     abnormalities caused by genetic or environmental factors. Cerebral vascular measurements~     offer important information on cerebral metabolism. However, either anatomical or functional~     studies of human brain development during this period are surprisingly scarce. Diffusion~     tensor imaging (DTi), a recently developed technology of magnetic resonance imaging (MRi), is~     capable of noninvasively delineating macroscopic anatomical components with high contrast and~     revealing structures at the microscopic level. Cerebral vascular quantification including~     cerebral blood flow (CBF) and cerebral metabolic rate of oxygen (CMRo2) can also be obtained~     through noninvasive MRi, specifically arterial spin labeling (aSL) and T2-relaxation under~     spin tagging (TRuST) MRi. in this proposed study, the structure and function of neonatal~     brain will be explored using noninvasive MRi technologies. 102 infants will be recruited and~     no sedation will be applied during MRi. The resultant database will provide reference~     standards for diagnostic radiology of premature newborns and reveal the vascular activities~     of these newborn brains. Specifically, three aims will be achieved:~        1. To delineate the anatomical development of complex structure in the cerebral wall and~          white matter tracts of neonatal brains at different equivalent gestational ages.~        2. To quantify the cerebral blood flow and metabolic rate of oxygen of neonatal brain.~        3. To correlate the structural and functional measurements with the gene transcriptome~          results.~   "
106751|NCT02170129|"~     Background: Maxillary sinus floor augmentation is a standard surgical procedure to increase~     bone height in the atrophic posterior maxilla for dental implant placement. In bone~     reconstructive surgery, in general, autogenous bone is considered as the gold standard,~     primarily due to its osteogenic potential and remodelling capacity. Bone substitutes are~     available that can overcome the limitations of autologous bone due to their osteoconductive~     properties and biocompatibility. Several studies seem to validate these concepts, but further~     comparative trials are needed.~      Aim: To compare the outcome of implants inserted in maxillary sinuses augmented with bovine~     bone grafts vs 50% bovine bone graft and 50% autologous bone according to a lateral approach.~      Material and Methods: This study was designed as a randomised, controlled, clinical trial.~     Sixteen partially or fully edentulous patients, 20 sinuses, (four patients have been~     bilaterally treated) having 1 to 4 mm of residual crestal height below the maxillary sinuses~     were randomised according to a parallel group design. Sinuses were grafted according to a~     lateral approach. Group A (10 sinuses) was grafted with 50% anorganic bovine bone (Bio-Oss)~     and 50% autogenous bone, group B (10 sinuses) was grafted with 100% anorganic bovine bone~     (Bio-Oss). According with a two stages approach, after 7 months a total of 32 implants (Nobel~     Replace tapered groovy) were inserted with an insertion torque between 35 and 45 Ncm. At same~     surgical procedure a sample of bone was harvested for histomorphometric analysis . All~     implants were delayed loaded with screw retained temporary crowns 3 months after implants~     insertion and with screw retained definitive crowns 4 months later. Outcome measures were~     implant survival, biological and prosthetic complications, radiographic marginal bone-level~     changes, PPD and BOP. Clinical data were collected at baseline 6,12 months. Statistical~     significance was tested at the 0.05 probability level, and all values were presented as mean~     and standard deviation.~   "
106752|NCT02170116|"~     The objective of this study was to assess safety, pharmacokinetics and the effect of BIBR 953~     ZW on coagulation parameters of BIBR 953 ZW after oral single doses of the prodrug, BIBR 1048~     MS, in healthy male subjects. This was the first administration of this substance to humans.~   "
106753|NCT02170103|"~     The investigators propose to test the effectiveness of a technique that uses a modified~     commercially available ultrasound system used for cardiac imaging, and a commercially~     available ultrasound contrast agent (microbubbles) to break up the blood clots that cause~     heart attacks. The ultrasound and microbubbles will be applied as soon as possible to~     patients presenting to the emergency department, after an EKG confirms that a heart attack is~     ongoing. Patients who provide emergent consent will be randomized to either conventional~     therapy for a heart attack, or conventional therapy and ultrasound with microbubbles. The~     ultrasound will be applied both before and after emergent heart catheterization, in order to~     break up the blood clots that are not only in the artery supplying the heart muscle, but also~     in the small branches (capillaries) that are fed by this artery. Following the randomized~     treatment, patients will be followed for the development of any complications (recurrent~     heart attack, heart failure, or need for defibrillator placement) as well as by echo and~     cardiac MRI to determine how much heart muscle was salvaged by the treatment. A total of 250~     patients will be enrolled and followed at two different sites. Randomization will be~     stratified at each study site. The initial site enrolling patients will be University of Sao~     Paulo Medical School. Wilson Mathias, MD, will serve as the principal investigator for this~     site. The other is VU University Medical Center in Amsterdam, where Otto Kamp, MD, will serve~     as the principal investigator.~   "
106754|NCT02170090|"~     This is a multicentre, two stage, prospective, randomized, controlled phase III trial~     designed to assess the clinical performance of gemcitabine with cisplatin and observation vs.~     standard of care (capecitabine) and observation in patients after curative intent resection~     of cholangiocarcinoma and muscle invasive gall bladder carcinoma.~   "
106755|NCT02170077|"~     The purpose of this study is to determine the efficacy of BIA 2 093 in the treatment of~     epileptic patients with refractory simple or complex partial seizures with or without~     secondary generalization.~   "
106756|NCT02170064|"~     The purpose of this study is to characterize the pharmacokinetics of Eslicarbazepine acetate~     in children and adolescents with epilepsy.~   "
106757|NCT02170051|"~     This study will compare Cognitive Behavioral Social Skills Training-Compensatory Cognitive~     Training (CBSST-CCT) to a goal-focused supportive contact group to see which intervention~     better improves symptoms and functioning in people with schizophrenia.~   "
106758|NCT02170038|"~     The clinical phase I study aims at investigating the conversion of the contraceptive compound~     norethisterone within the body towards the contraceptive compound ethinylestradiol. Therefore~     concentrations of ethinylestradiol will be measured from blood samples after administration~     of a single intramuscular dose of norethisterone. In a comparison arm concentrations of~     ethinylestradiol will be measured from blood samples after administration of a pill~     containing ethinylestradiol itself.~   "
106759|NCT02170025|"~     Assessment of the safety, tolerability and early signs of efficacy of three times a day~     orally administered BAY63-2521 in adult delta F508 homozygous Cystic Fibrosis patients not on~     treatment with Orkambi~   "
106760|NCT02170012|"~     The purpose of this study in healthy elderly people is to evaluate safety, toleration and~     time course of plasma concentration of multiple oral doses of PF-06743649- The~     pharmacodynamic activity of PF-06743649 will also be assessed.~   "
106761|NCT02169999|"~     The purpose of this study is to determine the impact of web-based personalized decision~     support on:~        1. Patient awareness of treatment goal options and ability to articulate their goals of~          diabetes care.~        2. Provider awareness of patients' clinical status (e.g. life expectancy) and treatment~          preferences.~        3. Individualization of care plans in accordance with geriatric diabetes guidelines.~   "
106763|NCT02169973|"~     The purpose of the study is to measure the uptake, distribution, and clearance of 11C-MK-3168~     by Positron Emission Tomography (PET) scan and to model the tissue specific kinetics of~     11C-MK-3168 with the appropriate input function in human brain in Part A; to measure blocking~     of retention of 11C-MK-3168 at the estimated time to maximum plasma concentration after~     dosing (tmax) following each single oral doses of JNJ-42165279 and model the exposure/enzyme~     interaction of JNJ-42165279 in Part B; to measure the saturation of enzyme inhibition in the~     brain at steady state plasma concentrations of JNJ-42165279 (on Day 8) after 7 once-daily~     doses of JNJ-42165279 by conducting PET studies with 11C-MK-3168 at trough plasma~     concentrations on Day 2 in Part C.~   "
106764|NCT02169960|"~     The majority of addiction and mental health problems seen in adults present first in youth.~     There is strong evidence that prevention and early identification during childhood can~     mitigate some of these risks. Students who screen at risk for the development of mental~     illness will be offered online intervention programs with personal guidance from a trained~     coach. In addition, lessons revolving around resiliency will be provided to all students.~      The objectives of this study are:~        -  Decreased rates of depression and suicide (as well as rates of suicide attempts)~        -  Decreased use of alcohol, tobacco, and other drugs, with additional downstream benefits~          such as reduced rates of fetal alcohol spectrum disorder (FASD) and cancer~        -  Decreased school drop-out rates Decreased rates of interactions with the justice system~        -  Decreased costs across a range of ministries (health, education, justice, human~          services), both for youth as well as their families who have been involved in this~          program~   "
106765|NCT02169947|"~     The WORD (Wholeness, Oneness, Righteousness, Deliverance) is a faith-based weight loss study~     in rural, African American adults of faith. The study will see whether a weight loss +~     maintenance intervention will cause participants to maintain their weight better than a~     weight loss only intervention.~   "
106766|NCT02169934|"~     The purpose of this study is to determine the routes of excretion for TRV130 and it's~     metabolites, and to determine and characterize, structurally, the metabolites present in~     plasma, urine, and feces in healthy male subjects.~   "
106767|NCT02169921|"~     The objective of this study is to evaluate the safety and effectiveness of the TurboHawk for~     the treatment of peripheral arterial disease (PAD) in the superficial femoral and/or the~     popliteal arteries with the Japanese population.~   "
106768|NCT02169908|"~     The role of oxidative stress in the development of oxaliplatin-induced peripheral neuropathy~     has been previously described in mice and in neuronal cell cultures (Massicot 2013); clinical~     manifestations and pathophysiological mechanisms potentially involved have also been~     described in humans (Andreas 2007) (Attal 2009).~      The investigators team plans to conduct a translational clinicobiological research to explain~     the nature of the biochemical and molecular mechanisms of the development of~     oxaliplatin-induced painful neuropathy. To perform this project, the investigators propose to~     realize a pilot study in patients newly treated with oxaliplatin. This will be conducted in~     the oncology department of Paris Saint Joseph Hospital from May 2014 until the inclusion of~     20 patients.~      The main objective of this pilot study is to evaluate the occurrence of acute and chronic~     neuropathic pain occurring in patients newly treated with oxaliplatin. The characterization~     of this pain is based on validated tests (Cruccu 2010).~      Moreover, the biochemical changes related to oxidative stress and those related to cellular~     lipid composition are characterized in these patients.~   "
106769|NCT02169895|"~     To investigate the effect of three single oral doses of BIA 9-1067 (25 mg, 50 mg and 100 mg)~     on the levodopa pharmacokinetics when administered in combination with a single-dose of~     immediate-release levodopa/benserazide 100/25 mg (Prolopa® 100-25)~   "
106770|NCT02169882|"~     Tuberculous meningitis (TBM) is the most severe form of tuberculosis infection with high~     mortality. Current treatment regimens are not based on clinical trials. Rifampicin is a key~     drug for TBM, but its penetration into the brain is limited, suggesting that a higher dose~     may be more effective.~      There are several highly relevant, outstanding questions related to the appropriate dose of~     rifampicin for TBM, before a multicenter phase 3 trial can be performed. These are:~        1. Previous phase 2a randomized clinical trial (done in the same setting as this proposed~          study) suggests that high doses of intravenous rifampicin (600mg, circa 13 mg/mg) for~          TBM is safe and associated with a survival benefit in adults. Given that i.v. rifampicin~          is not readily available, this needs to be confirmed using an equivalent higher oral~          dose of rifampicin.~        2. Recent pharmacokinetic analysis of a continuation trial comparing 600 mg i.v. rifampicin~          with 750 mg and 900 mg oral rifampicin suggests that an even higher dose may be needed;~          but this has not been examined~        3. Based on those previous data, there is a need to explore a longer duration of high-dose~          rifampicin for a subsequent phase 3 randomized clinical trial; treatment response in the~          investigators previous trial suggest that the optimal duration may be > 14 days.~        4. There is a need to explore relevant treatment endpoints besides mortality including~          neurological, neuroradiological and inflammatory response.~   "
106771|NCT02169869|"~     The study will be a randomized clinical trial. Women with less than 10 prenatal visits and/or~     2 or more no show visits who desire an Intrauterine Device (IUD) will be considered for~     enrollment. If consented and meet inclusion criteria, they will be randomized after delivery~     to receive an IUD immediately postplacental or at their routine postpartum visit.~      Women who plan to deliver a live birth singleton via vaginal or cesarean delivery at Oregon~     Health and Science University (OHSU) hospital will be considered for inclusion in the study.~     Women who desire an IUD for postpartum contraception will be approached for study~     participation. The postpartum contraception plan is routinely documented during their~     prenatal course. It is also addressed by the obstetrical team upon admission to Labor &~     Delivery at OHSU. The obstetrical team will identify subjects who present in labor who meet~     the criteria of poor prenatal clinic attendance and express interest in intrauterine~     contraception. Immediately after vaginal or cesarean delivery, consented subjects will be~     randomized to immediate postplacental IUD placement or IUD placement at their routine~     postpartum visit. Women randomized to the immediate postplacental IUD group will receive~     their IUD within 60 minutes of placental delivery. Prior to discharge from the hospital women~     who received a postplacental IUD will be assisted in scheduling a routine postpartum visit~     with their primary provider. Subjects who are randomized for IUD insertion at their~     postpartum visit will be assisted in scheduling a postpartum visit and IUD placement with~     their usual obstetrical care provider. All subjects in the delayed group will be provided~     with contact information for the Women's Health Research Unit (WHRU) at OHSU. If a subject~     cannot obtain an IUD at her usual place of care, the device will be placed at no cost through~     the WHRU.~      At 3 months after delivery, all subjects will be contacted by phone, text, or email to~     complete a questionnaire to determine whether they have had a known expulsion, pregnancy, or~     elective IUD removal. The questionnaire will include questions regarding ease of placement~     and overall satisfaction with the timing of placement. Subjects will be compensated for their~     participation in the study after the 3 month contact.~   "
106806|NCT02169414|"~     The purpose of this study is to determine the effect of BIA 9 1067 (5 mg, 15 mg and 50 mg) in~     steady-state conditions on the levodopa pharmacokinetics of a single dose of~     immediate-release levodopa/carbidopa 100/25 mg and of a single dose of immediate-release~     levodopa/benserazide 100/25 mg.~   "
106773|NCT02169843|"~     Dexmedetomidine Hydrochloride is a kind of high selectivity alpha 2 agonists adrenaline, can~     inhibit the activity of sympathetic nerve, and reduce the adverse effects of stress reaction~     in anesthesia recovery period.Literatures have been reported that Dex can reduce the rate of~     emergence agitation of children and adults,especially in elderly patients(>64 years) after~     using sevoflurane anesthesia.~   "
106774|NCT02169830|"~     The investigators' study plans to randomize treatment naive patients with vestibular migraine~     to an 8 week trial of an escalating dose of either nortriptyline or topiramate followed by an~     8 week crossover to the other drug if patient is willing, if patient wants to stay on first~     medication we will just continue to follow. During the first 8 weeks if there is an~     intolerance to the first drug they can be switched to the other drug at any point and then~     followed on that medication for the remainder of the study. Response to therapy will be~     quantified by the Migraine Specific Quality of Life (MSQ) and Dizziness Handicap Inventory~     (DHI) administered at multiple time points during the study. Three groups of patients that~     will be eligible for the study will include 1)Patients with Neuhauser dVM; 2)Patients with~     pVM; and 3) Patients with dizziness that falls outside the Neuhauser criteria (non-Neuhauser~     vestibular migraine or nNVM).~      The investigators' hypothesis is that even patients with dizziness outside of the Neuhauser~     dVM and pVM spectrum will respond to treatment for vestibular migraine, and thus likely have~     migraine as a cause of their dizziness. Previous research by our group has suggested that~     such patients do in fact respond to migraine therapy1. A second goal of the study is to~     evaluate the comparative efficacy of nortriptyline and topiramate in the treatment of these~     three subgroups of patients with vestibular migraine.~   "
106775|NCT02169817|"~     Primary Objective:~      To demonstrate the effectiveness of treatment with Bacillus clausii probiotic strain~     (Enterogermina) in combination with oral rehydration therapy (ORT) for a period of 5 days, in~     the duration of acute community-acquired diarrhea in Latin American children.~      Secondary Objectives:~      To evaluate the clinical safety of Enterogermina in acute diarrhea in children and to~     demonstrate its effectiveness on stool frequency, stool consistency, and number of vomiting~     episodes.~      To evaluate parent's overall global assessment. To evaluate the safety and effectiveness of~     Enterogermina in norovirus acute gastroenteritis (AGE).~   "
106776|NCT02169804|"~     • To determine and compare the pharmacokinetics (PK) of 3 doses of 25 mg Androxal in elderly~     healthy adult male subjects.~   "
106777|NCT02169791|"~     In an attempt to reduce relapse risk and improve outcomes following haploidentical~     transplantation for patients with high risk hematologic malignancies, the investigators will~     implement several strategies to augment the well documented effect of NK cell alloreactivity~     seen in HLA-mismatched transplantation. These strategies include (1) choosing potential~     haploidentical donors for optimal NK-alloreactivity, (2) utilizing proteasome inhibition~     post-transplant with MLN9708 to both sensitize tumor cells to NK cytotoxicity and protect~     against graft-versus-host disease (GVHD), and (3) eliminating mycophenolate mofetil from the~     post-transplant immunosuppression regimen to improve NK cell reconstitution following~     haploidentical peripheral blood stem cell transplantation.~   "
106778|NCT02169778|"~     Obesity has become a global epidemic with huge public health implications. Although clinical~     significant weight loss can be achieved by a combination of diet and behavioral modification,~     strong metabolic adaptations, with increased appetite and suppressed energy expenditure, are~     activated, which compromise weight loss maintenance and increase the risk of relapse. The aim~     of this project is to compare the effects of intermittent versus continuous energy~     restriction on the compensatory responses previously described using two low calory diets,~     with a similar macronutrient distribution. More specifically, this study will analyze, in the~     short-term, if an intermittent energy restricted diet is associated with less appetite and~     low reduction in energy expenditure when compared with a continuous energy restricted diet.~     This project can bring large practical benefits concerning the design of weight loss programs~     to minimize weight relapse.~   "
106779|NCT02169765|"~     Hepatocellular carcinoma (HCC) is the third leading death cancer in the world. It is~     important to explore a safe and effective therapy for early-stage HCC. Previous studies~     reported that radiofrequency ablation (RFA) has higher efficacy and is associated with fewer~     complications and shorter hospital stays than hepatic resection (HR) for early-stage HCC.~     However, meta-analysis and systematic review found that RFA is associated with higher~     recurrence rate and lower long-term overall survival.~   "
106780|NCT02169752|"~     This research study is looking at the use of the drug ambrisentan and if it can improve right~     ventricle function in people with systemic sclerosis-associated pre-pulmonary arterial~     hypertension. It is also looking at using right ventricle function changes as a marker of~     disease severity.~   "
106781|NCT02169739|"~     Previous studies in animals and humans has shown that brief periods of reduced blood flow to~     one organ or tissue in the body can help protect other tissues from subsequent injury caused~     by reduced blood flow such as a stroke. This phenomenon is known as remote ischemic~     preconditioning and may help protect brain cells after a stroke. The investigators are~     studying a specific stroke type called subcortical stroke that is very common and has a high~     rate of recurrent stroke and cognition problems despite intensive prevention measures.~   "
106782|NCT02169726|"~     Back injuries are the most common reason people seeking for effective treatment. One of the~     most common treatments in sports medicine for muscular injuries is therapeutic ultrasound,~     which is designed to heat the injured tissue and increase the flow of blood to promote~     healing.~   "
106783|NCT02169713|"~     The purpose of this study is to evaluate the effect of solifenacin and mirabegron on the~     concentrations of tamsulosin HCl after combined dosing. This study will also evaluate the~     safety and tolerability of the combined administration of solifenacin, mirabegron and~     tamsulosin HCl.~   "
106807|NCT02169401|"~     08-SMI-2012 is a post market, observational, questionnaire based study to assess the~     effectiveness of the commercially available Axium neurostimulator in the management of~     intractable, chronic pain.~   "
106808|NCT02169388|"~     Probiotics modulate the gut microflora and immune status in CRC,which can reduce the side~     effects of chemotherapy such as diarrhea,infection,neutropenia etc.~   "
108036|NCT02153320|"~     The purpose of this long-term follow-up study was to evaluate the persistence of the cellular~     and the humoral immune response 4 years after the first dose of GSK Biologicals'~     investigational vaccine formulations containing HBsAg (used as a model antigen) and an~     adjuvant.~   "
106784|NCT02169700|"~     Myofascial trigger points (MTrPs) are identified through physical examination as~     hypersensitive spots within taut bands of skeletal muscle, painful on compression, triggering~     characteristic referred pain and generating motor dysfunction as well as autonomic phenomena.~     Different dry needling procedures have been described in the treatment of MTrPs. Needling~     therapies which consist in partially inserting and withdrawing the needle from the trigger~     point site in order to elicit local twitch responses are associated with higher effectiveness~     in releasing MTrPs. Deep dry needling has obtained a grade A recommendation compared to sham,~     for immediate reduction of pain in patients with upper-quadrant myofascial pain syndrome.~     Nevertheless, trigger point dry needling are frequently associated to a post-needling~     soreness. The application of ischemic compression (IC) after trigger point injection in the~     upper trapezius muscle has shown higher reduction of pain and disability in myofascial pain~     patients, compared with trigger point injection alone. To the authors' knowledge, no previous~     studies have evaluated the effectiveness of IC or any manual therapy methods for the~     treatment of post-needling soreness. The aims of this study were: (a) to evaluate the~     effectiveness of IC on reducing post-needling soreness after dry needling of one latent MTrP~     in the upper trapezius muscle, and (b) to investigate the effect dry needling combined with~     IC, compared to dry needling alone and dry needling combined with placebo IC will have on~     cervical range of motion (c) to determine whether psychological factors are predictive of~     postneedling pain and (d) to analyze if the relationships between psychological variables and~     postneedling pain varied as a function of postneedling soreness treatment~   "
106785|NCT02169687|"~     The purpose of this study is to assess the efficacy and safety of High Intensity Focalized~     Ultrasound (HIFU) in the treatment for toxic Thyroids nodules~   "
106786|NCT02169674|"~     This study looks at protection in 10-11 and 15-16 year olds, immunized as infants with~     Hepatitis B (HB) vaccine to see if they still have residual protection against Hepatitis B~     disease. Adolescents will be invited to have a blood test and those without a minimal level~     of protection (antibody titer) will be offered a test vaccination to see if they still have~     capacity to recall an immune response. About one month later they will get another blood test~     to see if a booster response occurred. A few participants will have lost protection (no~     booster response) and will be offered a second HB vaccination to restore protection. Results~     of this study could influence the way in which children in British Columbia (BC) are~     immunized against HB disease.~   "
106787|NCT02169661|"~     Consumption of ready meals and other convenience foods are rapidly increasing. However,~     their nutritional value is problematical. For example, many are high in fats which are~     potentially oxidisable resulting in the formation of toxic end products. Consequently the aim~     of this study is to assess whether consumption of ready meals rich in certain fats leads to~     a post-prandial increase in lipid oxidation products in plasma and whether this can be~     ameliorated by reformulating the meals with natural extracts rich in phytochemicals with~     potential antioxidant activity in the stomach~   "
106788|NCT02169648|"~     The purpose of this study is to evaluate the efficacy of intravitreal ranibizumab by~     determining the pathogenesis of macular edema, which cause a direct effect on visual~     function. In particular, we focus on the correlation between the treatment effectiveness of~     ranibizumab and the role of the cytokines involved in the cause of macular edema.~   "
106789|NCT02169635|"~     High myopia is characterized by prolonged axial length and posterior staphyloma, which result~     in choroid-retinal degeneration and vision decrease. At present, vitrectomy can lead to~     anatomical improvements, but an higher axial length and the presence of a sever posterior~     staphyloma remains to be the two most important risk factors for poor visual outcomes. For~     these reasons, a different surgical approach, including macular buckling, might be considered~     in those patients with extremely high degree of myopia, in order to counteract the traction~     exerted by the posterior staphyloma. Macular buckling with or without pars plana vitrectomy~     had been proved to be an effective way to resolve myopic staphyloma related foveoschisis,~     macular hole, and associated retinal detachment. In this study, we sought to investigate the~     safety and efficacy of a macular buckling technique using a three-armed silicone capsule to~     support the posterior staphyloma in high myopia.~   "
106790|NCT02169622|"~     Atrial Fibrillation is an abnormal heart rhythm that can occur after coronary heart bypass~     graft operations. How often this happens and what other problems occur for a person after~     these operations needs to be better understood. This study uses a device called the Reveal~     XT, a small device that records heart rhythms to track a patient's heart rhythms after the~     bypass surgery. The device is implanted at the time the bypass graft is made. The information~     that is gathered for this study will help physicians to provide better treatment and~     follow-up of the patients under their care.~   "
106791|NCT02169609|"~     The purpose of this study is to evaluate safety of the triple COG schema with the monoclonal~     antibody Dinutuximab + cytokines (GM-CSF and IL2) and isotretinoin (13-cis-retinoic acid, or~     RA) in patients with high-risk neuroblastoma.~   "
106792|NCT02169596|"~     Background~      Acute coronary syndrome (ACS) is a term representing all diseases related to reduction in~     blood flow to the heart characterised by clot formation over a segment of blood vessel~     narrowing. A major constituent of clot are blood cells called platelets and many of the~     medications used in ACS target platelet function. Ticagrelor is known to reduce platelet~     activity in clot formation by blocking a specific step in the process (P2Y12 receptors). A~     recent study has found that the presence of ticagrelor may also reduce clot formation by~     significantly enhancing another process involving the molecule nitric oxide (NO). This is of~     particular interest if translates into clinical practice, as many patients with heart disease~     have abnormal function of their blood vessel lining. This is known to cause a reduction in~     available nitric oxide. Does this therefore mean these patients will have a reduced response~     to ticagrelor therapy and subsequently be at increased risk of clot formation?~      Aims~        1. Will ticagrelor increase the anti clot effect of vessel lining produced nitric oxide?~        2. Do patients with diabetes or smokers, who have poor function of their vessel lining,~          have a reduced response to ticagrelor?~      Methods~      This is a pilot study in which we propose to look at 64 patients with known disease of their~     heart blood vessels, with an equal mix of smokers, diabetics, smoking diabetics and non~     smoking non diabetics. We will also recruit ten healthy normal subjects to ensure that our~     tests produce the same results as the basic science study mentioned above.~      To answer the questions posed we will perform blood tests, primarily looking at platelet~     function, and non-invasive blood vessel lining assessment. This will be done before and after~     ticagrelor treatment on each participant, enabling statistical comparison.~   "
106844|NCT02168920|"~     To evaluate the efficacy (based on mean change in Cohen-Mansfield Agitation Inventory [CMAI]~     total score from baseline as the primary efficacy variable), dose-response, and safety of~     aripiprazole at 2, 3, and 6 mg/day in comparison with placebo in patients with agitation~     associated with Alzheimer's type dementia~   "
106793|NCT02169583|"~     This will be the first time GSK1325756 Solution for Infusion formulation that has been~     administered to humans. Prior studies have been performed with oral GSK1325756. The primary~     objectives of this study are to obtain information on the safety, tolerability, and~     pharmacokinetics (PK) of single and twice daily intravenous (IV) administration of GSK1325756~     in healthy subjects. In Part A, single, escalating doses will be given in the same cohort of~     subjects after a seven day washout. In addition, the study will evaluate the absolute~     bioavailability of a single dose of the current oral tablet formulation as compared to the IV~     formulation in Part A. In Part B, twice daily (BID) intravenous dose administration will be~     given for 5 days (9 total doses) in two separate cohorts of subjects. Data from this study~     will provide understanding of the safety, tolerability, and PK of intravenously administered~     GSK1325756 twice daily to guide dose selection in future clinical studies in patients with~     viral respiratory tract infections~   "
106794|NCT02169570|"~     Pakistan ranks fifth amongst high tuberculosis-(TB) burden countries, where TB persists as a~     major cause of misery and death. The Diabetes Mellitus-(DM) is also on rise in Pakistan and~     people suffering from DM are more prone to catch TB as compared to healthy individuals. This~     concurrence of two outbreaks may further increase the frequency of TB in Pakistan. The TB DM~     co-occurrence results in various clinical issues as TB in DM patient increases blood glucose,~     making DM more difficult to treat, while DM raises the risk of treatment failure, relapse and~     death among TB patients. In addition, both DM and TB usually coexist with micronutrients~     deficiencies like vitamin D, which has a vital role in immunity, insulin functioning and~     respiratory health. It has been suggested that the combined supplementation with vitamin D~     and calcium might be beneficial in improving the glucose metabolism but the current knowledge~     is very limited. In a resource restrained country with double burden of infectious and~     non-infectious diseases, an integrated approach with modification of treatment options may~     benefit in management of these outbreaks.~      Therefore, this study aims whether vitamin D and calcium supplementation could influence the~     recovery in patients with TB of lung and DM.~   "
106795|NCT02169557|"~     The purpose of this study is to demonstrate the treatment success of fexinidazole, at one~     year follow-up visit, in HAT stage 1 and early stage 2 patients.~   "
106796|NCT02169544|"~     The purpose of this study is to evaluate the risk of infections and malignancies among~     Rheumatoid Arthritis (RA) patients treated with Abatacept compared to other RA treatments.~   "
106797|NCT02169531|"~     Diabetes mellitus type 2 is a long-term metabolic disorder that is primarily characterized by~     insulin resistance, relative insulin deficiency and hyperglycemia. Our hypotheses is that~     liver would be the primary organ responsible for the metabolic disorder because of some~     unknown defects, where sugar would not be efficiently converted to glycogen and fat, leading~     to hyperglycemia. The constant hyperglycemia would keep pressure on beta-cells in the~     pancreas to eventually exhaust their ability to produce and secret sufficient amount of~     insulin, exacerbating the disease. The Immunotherapy would enhance the liver functions and~     correct the abnormal sugar metabolism. In addition, the ex vivo activated cells produce and~     secret growth factors which would help endothelial cells of blood vessels to reproduce and~     grow, resulting in reduced arteriosclerosis.~   "
106798|NCT02169518|"~     The incidence of coronary heart disease (CHD) is significant in the super-obese and~     diabetics.~      Inflammation is believed to play an important part in the development of CHD, and the large~     collection of abdominal fat in the obese person is a vast source of inflammation. Diabetics~     have abnormal glucose and cholesterol metabolism which ultimately compromise their bodies'~     circulatory system and nerve function.~      Cholesterol plays a vital role in CHD. Low-density lipoprotein (LDL) particles carry~     cholesterol and deposit it in blood vessel walls which become damaged as a result. When LDL~     particles undergo changes chemically (called oxidation) or as a result of high circulating~     blood glucose (called glycation), they become more harmful to the body. High-density~     lipoprotein (HDL) particles have a protective function in CHD. Not only do they transport~     cholesterol away from the blood vessels to the liver to be broken down, they have properties~     against oxidation and inflammation. These properties are related to the activity of an enzyme~     on HDL called paraoxonase 1(PON1).~      Super-obese patients are increasingly treated by weight-reducing surgery (bariatric surgery).~     In this study we examine whether weight loss following bariatric surgery results in reduced~     inflammatory state, improved HDL function (higher PON1 activity), better control of blood~     glucose and less nerve damage.~      We will study PON1 activity, inflammation and glucose control in patients with type 1~     diabetes (with and without kidney damage) and type 2 diabetes. We will also study the effects~     of rapidly rising blood glucose levels on PON1 and glycated LDL in patients undergoing oral~     glucose tolerance test.~   "
106799|NCT02169505|"~     The goal of this clinical research study is to study the safety of ADCETRISTM (brentuximab~     vedotin) in patients with Hodgkin lymphoma or ALCL who have had an allogeneic or~     haploidentical stem cell transplant. Another goal of this study is to learn if brentuximab~     vedotin can help to prevent the disease from coming back.~   "
106800|NCT02169492|"~     The main objective of this study is to assess the safety and effectiveness of the ReVive SE~     (Self- Expanding) Neurothrombectomy Device in subjects requiring mechanical thrombectomy when~     used according to its Instruction for use (IFU).~   "
106801|NCT02169479|"~     To investigate the effect of three single oral doses of BIA 9-1067 (25 mg, 50 mg and 100 mg)~     on the levodopa pharmacokinetics when administered in combination with a single-dose of~     immediate-release levodopa/carbidopa 100/25 mg (Sinemet® 100/25)~   "
106802|NCT02169466|"~     To investigate the effect of three single oral doses of BIA 9-1067 (25 mg, 50 mg and 100 mg)~     on the levodopa pharmacokinetics when administered in combination with a single-dose of~     controlled-release levodopa 100 mg/benserazide 25 mg (Madopar HBS).~   "
106803|NCT02169453|"~     To investigate the effect of three single oral doses of BIA 9-1067 (25 mg, 50 mg and 100 mg)~     on the levodopa pharmacokinetics when administered in combination with a single-dose of~     controlled-release levodopa/carbidopa 100/25 mg (Sinemet® CR 100/25)~   "
106804|NCT02169440|"~     The purpose of this study is to investigate CYP2C9 inhibition by BIA 9-1067 through the~     assessment of its effect on the pharmacokinetics of S-warfarin, a substrate of CYP2C9.~   "
106805|NCT02169427|"~     The purpose of this study is to determine the rate and routes of excretion of OPC and the~     mass balance in urine, faeces and expired air.~   "
106809|NCT02169375|"~     Sensorimotor (also know as mu) rhythm based brain-computer interfaces (BCIs) are a tool for~     controlling electronic devices using only brain signals. Often, the computer software that~     analyzes mu-rhythm brain signals constantly adapts to the individual user's brain signals~     when the training target location is known. The investigators want the BCIs to be more~     universal, and not depend on knowing the target location. Therefore, the investigators will~     test the effect removing adaptation has on accuracy of using a mu-rhythm BCI.~   "
106810|NCT02169362|"~     The study will examine the safety of using a concentration of proteins from a patient's own~     blood, referred to as platelet rich plasma or (PRP) and applying it to a second degree burn~     wound.~   "
106811|NCT02169349|"~     The purpose of this study is to develop an ultra sensitive assay of mutation detection on~     circulating tumor DNA (ctDNA) for treatment, diagnosis and monitoring disease progression of~     Non-Small Cell Lung Cancer (NSCLC).~   "
106812|NCT02169336|"~     The primary objective of this study is to evaluate the analgesic efficacy of two dose levels~     of DEX-IN compared with placebo, using the summed pain intensity difference over the first 48~     hours (SPID48) in subjects with acute moderate to severe pain following unilateral~     bunionectomy.~   "
106813|NCT02169323|"~     There is growing evidence that non-eosinophilic asthmatics are less sensitive to inhaled~     corticosteroids (ICS) than eosinophilic asthmatics.~      As non-eosinophilic asthmatic patients are treated by ICS according to international~     guidelines for asthma, the investigators would like to investigate whether stepping-down of~     ICS in these patients may be safe. Indeed, the investigators can reasonably expect that a~     progressive cessation of ICS is possible in some of these patients without any clinical~     worsening.~   "
106814|NCT02169310|"~     Background:~      - People with a traumatic brain injury (TBI) can have trouble making the best possible~     decisions. Researchers want to learn more about the parts of the brain that control decision~     making. They also want to know how these are different between people. This may help predict~     how people make decisions after TBI.~      Objective:~      - To learn more about which parts of the brain are involved in making decisions and how~     decisions may be hurt after TBI.~      Eligibility:~      - Adults age 18 to 60.~      Design:~        -  Participants will be screened with medical history and physical exam. They will also~          take memory, attention, concentration, and thinking tests.~        -  Participants will do up to 2 experiments.~        -  For Experiment 1, participants may have 3 scans:~        -  PET: a chemical is injected through a thin tube into an arm vein. Participants lie on a~          bed that slides in and out of the scanner.~        -  MRI: a strong magnetic field and radio waves take pictures of the brain. Participants~          lie on a table that slides in and out of a metal cylinder. It makes loud knocking~          noises. Participants will get earplugs. They might be asked to do a task. A coil will be~          placed over the head.~        -  MEG: a cone with magnetic field detectors is lowered onto participants head.~        -  After the scans, participants will perform a decision-making task.~        -  For Experiment 2, participants will perform a decision-making task before and after~          receiving transcranial direct current stimulation (tDCS).~        -  tDCS: wet electrode sponges are placed over participants scalp and forehead. A current~          passes between the electrodes. It stimulating the brain.~        -  Participants will return 24-48 hours later to repeat the decision-making task.~   "
106815|NCT02169297|"~     The purpose of this pilot study was to evaluate effectiveness of a novel regional anesthesia~     technique developed at the investigators institution, as part of a quality improvement~     initiative, to assist with multilevel thoracic pain control in post-Nuss procedure patients.~     The investigators hypothesized that the local anesthetic infusion via bilateral~     multiperforated soaker catheters placed at extrathoracic sub-paraspinal muscle location under~     ultrasound guidance would significantly improve pain control, as reflected by the decrease in~     pain intensity score, reduction in opiate requirement and improvement infunctional~     rehabilitation measure scores in patients who underwent the Nuss procedure for pectus~     excavatum repair. However, the goal of this pilot study was not to detect a statistically~     significant difference in the primary outcomes between control and treatment groups (as the~     number of study subjects was chosen out of necessity of what could be completed within a~     specified time period), but to estimate the parameters which allows appropriate power and~     sample size calculations for a future multi-institutional study.~   "
106816|NCT02169284|"~     This randomized phase II trial studies how well erlotinib hydrochloride works in treating~     patients with bladder cancer undergoing surgery. Erlotinib hydrochloride may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth.~   "
106817|NCT02169271|"~     This randomized phase II trial studies acetylsalicylic acid compared to placebo in treating~     high-risk patients with subsolid lung nodules. A nodule is a growth or lump that may be~     malignant (cancer) or benign (not cancer). Chemoprevention is the use of drugs to keep cancer~     from forming or coming back. The use of acetylsalicylic acid may keep cancer from forming in~     patients with subsolid lung nodules.~   "
106818|NCT02169258|"~     1. The prevalence of significant and complex obstructive coronary artery disease (CAD) is~          high in patients who have low extremity artery disease (LEAD).~        2. Long-term prognosis of LEAD undergoing percutaneous transluminal angioplasty (PTA)~          remains poor and CAD is an independent predictor of total mortality after PTA.~        3. This prospective randomized controlled trial will evaluate the prognostic effects of~          routine versus selective coronary angiography before PTA for LEAD and elucidate the~          potential mechanism.~   "
106819|NCT02169245|"~     The objectives of the research are to assess the effects of increased protein and fiber~     intake at breakfast on neural activation in brain regions associated with appetitive drive~     and reward-driven eating, measures of subjective appetite, and ingestive behavior in~     overweight adults. Additional outcomes of interest include the effects of the breakfast~     intervention on blood sugar and cholesterol profiles.~   "
106858|NCT02168738|"~     The purpose of this study is to compare three lipidic forms of DHA in their metabolic pathway~     in human by using 13C labeled molecules.~      The circulating form of DHA plays a major role in his cerebral incorporation. The aim of this~     research is to confirm that some lipidic forms are best carriers for the cerebral~     incorporation in studying 13C-DHA distribution in plasma lipids and blood cells.~   "
108060|NCT02153008|"~     To demonstrate the clinical performance of the Strep A FIA and Sofia, using throat swabs~     collected from symptomatic subjects.~   "
106820|NCT02169232|"~     Endotracheal intubation of the morbidly obese is often performed awake. Fiberoptic~     bronchoscope assisted endotracheal intubation, a commonly utilized technique for securing an~     airway while a patient is awake, has many limitations. The video laryngoscope is a device~     that is similar to a conventional laryngoscope but uses a video system to visualize the~     larynx. Because of its low cost, ease of use, and usefulness in the presence of edema or~     bleeding that may obstruct the airway, video assisted laryngoscopy has been shown to be~     useful for awake endotracheal intubations. However, a direct comparison of the fiberoptic~     bronchoscope with video assisted laryngoscopy has not been performed for awake endotracheal~     intubations in of obese patients. Patients undergoing laparoscopic gastric bypas~     andrecquiring awake intubations will be randomized for either fiberoptic bronchoscope or~     video assisted laryngoscopy. The investigators primary outcome will be the time required for~     successful intubation.~   "
106821|NCT02169219|"~     The purpose of this pilot study is to test whether an 8-week course of glucocorticoids,~     combined with rituximab, is effective in treating ANCA-associated vasculitis.~   "
106822|NCT02169206|"~     This study on frozen shoulder addressed the null hypothesis that there is no difference in~     the motion of scapula against the thoracic wall between affected and non-affected shoulder.~   "
106823|NCT02169193|"~     Microaspiration of contaminated oropharyngeal secretions and gastric contents frequently~     occurs in intubated critically ill patients, and plays a major role in the pathogenesis of~     ventilator-associated pneumonia. Quantitative pepsin measurement in tracheal aspirates would~     be useful in diagnosing microaspiration of gastric contents in intubated critically ill~     patients. Technetium 99m labelled enteral feeding is the gold standard for the diagnosis of~     microaspiration. The investigators hypothesized that tracheal pepsin measurement is a good~     diagnosis marker of microaspiration compared to the gold standard.~   "
106824|NCT02169180|"~     The purpose of this study is to evaluate overall response rate (ORR) (complete response [CR]~     rate plus partial response [PR] rate) of ibrutinib (IMBRUVICA™; PCI-32765; JNJ-54179060), as~     assessed by an Independent Review Committee (IRC), in participants with relapsed or~     refractory mantle cell lymphoma (MCL-a cancer of the lymph nodes or tissues).~   "
106825|NCT02169167|"~     Prevalence of diabetic foot ulcers are reported to be 15% in patients who suffer from~     diabetes and ulcerations are present in 84% of all diabetes-related amputations. Peripheral~     neuropathy leading to unperceived trauma seems to be the major cause of diabetic foot ulcers~     with 45-60% of ulcers to be considered merely neuropathic and 45% of mixed, neuropathic and~     ischemic etiology. Ulceration of lower limb is one of the most common complications related~     with diabetes and one of the major causes for hospitalization of diabetic patients. The most~     significant contributors to diabetic lower limb ulceration are neuropathy, deformity,~     uncontrolled elevated plantar pressure, poor glycemic status, peripheral vascular disease,~     male gender and duration of diabetes. Treatment of lower limb ulcers imposes an enormous~     burden on health care resources worldwide, and at least 33% of all expenses are spent to~     treat diabetic ulcers manifested as a complication of diabetes.~      Although at least 170 topical wound care products are available, evidence of the superiority~     of one over another is tenuous, well-designed randomized, controlled trials are rare, and the~     number of case-control or observational studies is limited. In recent years, salve prepared~     from Norway spruce (Picea abies) resin has successfully been used in medical context to treat~     both acute and chronic wounds and ulcers of various origins. The objective of this~     prospective, randomized and controlled clinical trial is to investigate healing rate and~     healing time of neuropathic diabetic foot ulcer in patients, who are suffering from infected~     fore- or mid-foot ulceration (PEDIS-classification ≥ Grade II; 19) originated from Type I or~     II diabetes, and in patients whose diabetic ulcerations are candidates for topical treatment~     with resin (Study treatment) or octenidine (Control treatment). In addition, factors~     contributing with delayed healing of ulceration, antimicrobial properties, safety and~     cost-effectiveness of the resin salve treatment and control treatment will be analyzed.~   "
106826|NCT02169154|"~     This research study is being conducted to investigate the skin irritancy potential of a new~     medication which contains two active ingredients (diclofenac and menthol) together in a gel~     formulation and is being developed to treat mild to moderate pain and inflammation, such as~     acute sport injuries, sprains and strains.~   "
106827|NCT02169141|"~     This is an open label observational pharmacokinetic drug study to evaluate Levofloxacine and~     Capreomycin in patients with Multidrug-Resistant Tuberculosis (MDR-TB).~   "
106828|NCT02169128|"~     Severe necrotizing soft tissue infection (NSTI), including necrotizing fasciitis, is a life~     threatening infection that spreads quickly to cutis, sub-cutis, fasciae and muscles.~     Approximately 40% of all patients with infections caused by S. Pyogenes develop a~     streptococcal toxic-shock syndrome. In these cases the mortality rates exceed 40% in spite of~     adequate treatment with antimicrobials. Due to the rapid progress, the extensive damage on~     soft tissues and high risk of death, the microbes are called flesh-eating bacteria. The~     present study is a spin-off of the larger EU funded INFECT study, looking at the experiences~     of patient and family to understand the impact on every day life. The present prospective~     mixed methods study has the potential to provide important knowledge regarding the occurrence~     of early signs and symptoms of NSTI, quality of life 6 and 24 months after diagnosis, and how~     the care and treatment can be optimized and organized in a person/patient and family centered~     way. The study also aims at validate the SF 36 questionnaire for this group of patients.~   "
106829|NCT02169115|"~     Urticaria is a very frequent skin condition characterized by transient wheal and flare type~     skin reactions associated with severe pruritus. In Europe alone, more than 5 million patients~     are thought to suffer from persisting urticaria symptoms, which either occur spontaneously,~     i.e. in chronic spontaneous urticaria (CSU), or as a result of environmental physical stimuli~     such as friction, pressure, UV irradiation or cold (physical urticaria). Urticaria factitia~     (also known as dermographic urticaria and symptomatic dermographism) is characterized by~     whealing and itching following a minor stroking pressure, rubbing or scratching of the skin.~     The majority of patients with urticaria factitia benefits from treatment with nonsedating~     antihistamines. Some patients, however, do not achieve adequate symptom control even with~     updosing of antihistamines and may suffer from substantial quality of life impairment . Since~     even very minor stroking of the skin can lead to the development of wheals and severe~     itching, these patients are for example limited in their choice of clothing and are impaired~     in their social interaction and partnership.~      In all patients with a history of wheals after stroking of the skin, a provocation test~     should be performed. This can be done by stroking of the skin lightly with a smooth blunt~     object (e.g. the tip of a closed ball point pen or a wooden spatula) or a purpose-built~     instrument, known as a dermographometer. For the diagnosis of symptomatic dermographism, the~     smooth blunt object should be held perpendicular to the skin and should be used to apply a~     light stroking pressure to the skin of the upper back or volar forearm. The reaction is~     considered positive in patients who show a weal response and report pruritus at the site of~     provocation.~      Patients with a positive test reaction should be evaluated for individual pressure~     thresholds. For this purpose a provocation device (FricTest) has been developed that allows~     for reproducible and standardized threshold testing. Threshold testing enables physicians to~     assess disease severity and treatment response more precisely.~   "
107083|NCT02165748|"~     Aim of this prospective observational study -in patients undergoing craniotomy for supra or~     infratentorial surgery as elective or emergency procedure- is to test the hypothesis that~     severe intraoperative hyperglycemia (BGC ≥180mg/dl) is associated with an increased incidence~     of infections within the first postoperative week (pneumonia, blood stream, urinary, surgical~     site/wound and cerebral infections)(NCT01923571).~   "
106830|NCT02169102|"~     Anxiety, pain and discomfort are common stressful situations that occur during the dentistry~     practice, especially in the urgency endodontic practice. Studies have concluded that low~     intensity laser therapy is effective in treating pain. However, most studies have reported~     the low intensity laser therapy in chronic pain, few studies have shown its application on~     acute pain and none have evaluated the low intensity laser´s analgesic effect in acute pain~     of the pulp inflammation. Since the pulp tissue has the peculiar characteristic to be~     surrounded by dentin, in acute pulpits, the inflammatory reaction is more complicated than~     usual. Furthermore, during the inflammatory process, sometimes anesthesia is not always~     completely effective. Thus, this present study aims to evaluate whether previous therapy with~     low intensity laser could, by its analgesic effect, promote greater comfort especially to~     this type of patient. 60 patients with acute pulpits pain will be selected to this study~     (randomized and double-blinded) and they will be divided in 4 groups:~      Group 1 ( n=15) - Control Group; Group 2 (n=15) - Laser 1: 780 nanometers (nm); 40 milliwatts~     (mW); 4 seconds per point; 0.16 Joules/point; total irradiated points: 02; Group 3 (n=15) -~     Laser 2: 780nm; 40 mW; 40 seconds per point; 1.6 Joules/point, total irradiated points: 02;~     Group 4 (n=15) - Placebo group - Sham Laser Irradiation.~      The pain will be evaluated by a visual analogue scale (VAS) in 3 different times: initial~     pain, pain immediately after and 15 minutes after interventions (laser irradiation, or sham~     laser irradiation). After that, patients with acute pulp irreversible inflammation will be~     submitted to conventional endodontic urgency treatment. Data concerning the need of~     complimentary local anesthesia will be also taken into account. Data of different groups and~     times will be statistically compared.~   "
106831|NCT02169089|"~     Atherosclerotic disease, or hardening of the arteries, is characterized by the thickening of~     the arterial walls due to fatty deposits in wall and inflammation in the wall of arteries.~     High cholesterol, high blood pressure, diabetes, obesity and genetics play an important role~     in developing clinical symptoms of atherosclerosis disease. The complications of advanced~     atherosclerosis are chronic, slowly progressive and cumulative, resulting in heart attack,~     stroke and/or death and blockage of arteries.~      This study is being done to assess the effectiveness of Spironolactone therapy to slow down~     the worsening of atherosclerotic disease (hardening of the arteries) in aorta (this is a~     large vessel coming out of your heart) compared to placebo (look alike sugar pill). This will~     be checked by comparing before and after therapy magnetic resonance imaging (MRI) pictures of~     your aortic wall.~      Spironolactone is an FDA approved drug used to treat heart failure and in the management of~     hypertension (high blood pressure), but in this study it is used for another unapproved~     reason. In this study, we would like to evaluate the effects of Spironolactone in people with~     diabetes and atherosclerotic disease.~   "
106832|NCT02169076|"~     Left Ventricular Assist Devices (LVAD) are mechanical heart pumps that are increasingly being~     implanted in patients with severe heart failure which have failed medical therapy. In~     patients with LVADs, right ventricular failure, which is not supported by the LVAD pump, is a~     major problem that affects quality-of-life and survival. Cardiac Resynchronization Therapy~     (CRT) aims to restore the synchronized contraction of the heart and has proven to be~     beneficial for improving ejection fraction of both right and left ventricle as well as~     quality of life in selected heart failure patients. The role of CRT in patients with LVADs is~     unknown. We hypothesize that CRT can exert a beneficial impact on right ventricular function~     in LVAD patients and improve their quality-of-life.~      The specific questions that this study aims to answer are:~        1. What are the effects of CRT on the function of the non-supported right ventricle in~          patients with an implanted LVAD?~        2. Can the effects of CRT on cardiac function positively impact quality-of-life and~          exercise capacity in LVAD recipients?~      In this study patients with a previously implanted CRT device, who later receives an LVAD,~     will be randomly assigned to have the CRT turned off (CRT-off) or on (CRT-on). The patients~     will be followed for an 8-week period, and then switched over to the opposite CRT status. The~     total participation in this study will last for 16 ± 1 weeks, and will involve 3 clinic~     visits of approximately 3 hour duration (initial visit, 8 week visit, and 16 week final~     visit), plus 2 quick checks of the pacemaker/defibrillator in-between the visits. Heart~     function will be assessed with comprehensive echocardiographic studies during the CRT on~     and CRT off periods. Quality-of-life and exercise capacity will be assessed with a~     standardized questionnaire and a 6-Minute Walk Test.~   "
106833|NCT02169063|"~     This clinical trial studies carbon-11 acetate and fluorine F 18 sodium fluoride positron~     emission tomography (PET) as a biomarker of treatment response in patients with prostate~     cancer that does not respond to treatment with hormones and has spread to other parts of the~     body. Carbon-11 acetate and fluorine F 18 sodium fluoride are radioactive drugs that may be~     useful in evaluating prostate cancer activity in response to treatment. Comparing results of~     diagnostic procedures such as carbon-11 acetate and fluorine F 18 sodium fluoride PET done~     before and after therapy may help doctors predict a patient's response to treatment and help~     plan the best treatment.~   "
106834|NCT02169050|"~     Obesity is associated with low-grade inflammation, insulin resistance and low vitamin D~     status. Vitamin D has traditionally been known to involve in calcium homeostasis and prevent~     rickets; however, recently it has been recognized to inversely associate with many~     non-skeletal diseases and conditions including obesity and type 2 diabetes (T2DM). In vitro~     studies have demonstrated that vitamin D possesses anti-inflammatory properties. It remains~     unknown if the effect of vitamin D on insulin sensitivity is mediated by suppressing~     inflammation in human adipose tissues. The main objective of this study was to assess the~     association between vitamin D and insulin sensitivity and inflammation in morbidly obese~     pre-menopausal women. Obese women (n=76) were recruited from the University of Illinois at~     Chicago (UIC) Nutrition and Wellness Center and the UIC medical center bariatric surgery~     clinics. Insulin sensitivity/resistance was assessed by (1) Oral glucose insulin sensitivity~     (OGIS) index, derived from dynamic oral glucose tolerance test (OGTT), and (2) Homeostasis~     model of insulin resistance (HOMA-IR), calculated from fasting steady-state glucose and~     insulin. Also, to better understand the potential mechanism and the role circulating vitamin~     D (25OHD) plays in adipose tissue inflammation, we assessed messenger ribonucleic acid (mRNA)~     expression of vitamin D receptor (VDR) and various inflammatory genes in visceral (VAT) and~     subcutaneous adipose tissues (SAT) of obese women that underwent a restrictive bariatric~     procedure. We hypothesized that subjects with higher serum vitamin D levels would be less~     inflamed and more insulin sensitive and have increased expression of VDR and pro-inflammatory~     markers compared to those with lower serum vitamin D levels.~   "
106835|NCT02169037|"~     This is a prospective randomized study to assess the safety and efficacy of FIRM (Focal~     Impulse and Rotor Modulation)-guided ablation for the treatment of symptomatic atrial~     fibrillation (AF). The study hypothesis is that the efficacy of AF elimination at 1 year will~     be higher by ablating patient-specific AF-sustaining rotors and focal sources by Focal~     Impulse and Rotor Modulation (FIRM) compared to conventional ablation alone (wide-area PV~     isolation).~   "
106859|NCT02168725|"~     The main objectives of this study are to determine the safety profile of briciclib, an~     experimental anti-cancer drug, as it is administered intravenously once weekly as escalating~     doses in adult patients with advanced cancer and solid tumors, and to determine the highest~     dose of briciclib that can be safely given. Secondary objectives are to determine how the~     amount of briciclib in circulation changes over time and how much briciclib gets into the~     urine for excretion, and to document potential anti-tumor effects of briciclib.~   "
106836|NCT02169024|"~     This study addresses the intractable challenges of adverse birth outcomes, including preterm~     delivery and low birthweight, by proposing the development, implementation and evaluation of~     a model of group prenatal care that could be scaled nationally. Group prenatal care models~     have been demonstrated through rigorous research to provide significantly improved birth~     outcomes with implications for maternal-child health and substantial cost savings. However,~     group prenatal care is currently available to only a small fraction of the more than four~     million women who give birth annually in the US. Through the development, implementation and~     evaluation of a new model of group prenatal care, we will create an outcomes-focused model of~     group prenatal care that will be scalable nationally with an eye toward improving US birth~     outcomes.~      The long-term objective of the proposed study is to reduce the risk for adverse perinatal~     outcomes during and after pregnancy among women and families receiving prenatal care in~     health centers in 3 geographic locations serving vulnerable populations: Hidalgo County~     Texas, Nashville Tennessee, and Detroit Michigan. We will develop, disseminate, and evaluate~     a new and improved model of group prenatal care, Expect with Me, based on our previous~     research on group models of prenatal care, which has already yielded favorable behavioral and~     biological results in two randomized controlled trials.~      We hypothesize that, relative to women who receive standard individual prenatal care, the~     women who receive Expect with Me group prenatal care will be significantly more likely to:~        1. have better perinatal outcomes, including better health behaviors during pregnancy~          (e.g., nutrition, physical activity), better birth outcomes (e.g., decreased preterm~          labor, low birthweight, Neonatal Intensive Care Unit stays), and better postpartum~          indicators (e.g., increased breastfeeding);~        2. report greater change in risk-related behaviors and psychosocial characteristics that~          could be considered potential mechanisms for the program's effectiveness;~        3. have lower rates of sexually transmitted diseases and rapid repeat pregnancy one year~          postpartum;~        4. have lower healthcare costs through improved outcomes (e.g., appropriate care~          utilization, fewer complications, reduced NICU admissions/length of stays)~      Comparisons based on propensity-score matched sample of women receiving standard individual~     prenatal care at the same clinical sites.~   "
106837|NCT02169011|"~     The purpose of this study is to examine the different outcomes of breast reconstruction in~     women who are treated for breast cancer with mastectomy and subsequently have delayed breast~     reconstruction by one of two different surgical techniques both of which are based on the use~     of a tissue flap from the patient's back. These techniques are either a latissimus dorsi flap~     (LD-flap) or a thoracodorsal artery perforator flap (TAP-flap)~      The main objective of the study is to establish whether one of these techniques may result in~     a superior outcome and thus should be recommended as first choice treatment rather than the~     other.~   "
106838|NCT02168998|"~     The purpose of this study is to determine whether the presence of a medical clown in a~     pediatric emergency department procedure room would reduce children's anxiety. The~     investigators hypothesize that this positive influence will be expressed as lower levels of~     the stress hormone (Cortisol) in the blood.~   "
106839|NCT02168985|"~     The Faithful House (TFH), is a 3-day faith-based skills-building curriculum which aims to~     increase household resilience by strengthening families. TFH draws on improved communication~     and conflict resolution skill building and the individual's faith-values as a catalyst for~     transformation in attitudes regarding gender roles in care giving and the use of violence in~     the home. The study hypothesis is that couples who complete the Faithful House Programme will~     demonstrate increased communication skills with their spouses and children, which reduces the~     negative impact of family stress triggers and ultimately leads to a reduction of intimate~     partner violence witnessed by children as well as physical and emotional violence against~     children by parents.~      The mixed methods study will include a Randomized Control Trial (RCT) of HIV/AIDS infected or~     conflicted couples and a child in each household, focus group discussions (FGD) of men, women~     and children and key informant interviews of local experts in family violence and social~     protection service network providers.~   "
106840|NCT02168972|"~     The purpose of this study is to provide clinical data pertaining to the safety and~     performance of the Globe® Mapping and Ablation System for treating patients with atrial~     fibrillation.~   "
106841|NCT02168959|"~     The primary purpose of the proposed study is to compare postoperative pain scores and total~     opioid consumption between two groups randomized to either receive or not receive a femoral~     nerve block for pain control following surgical repair of a tibial plateau fracture. Pain~     will be assessed post-operatively using standard numeric pain scores rated on a 0 - 10 scale,~     as well as using the University new pain assessment tool - the Clinically Aligned Pain~     Assessment (CAPA). This new 5 question pain assessment tool has not yet been validated, but~     does address several key questions, including patient comfort, pain control, change in pain~     status, daily functioning, and sleep quality. Along with post-operative pain scores, we will~     compare total opioid consumption between the two groups.~      The null hypothesis is that there is no difference in pain scores or total opioid consumption~     between patients receiving a femoral nerve block and those without a nerve block following~     surgical repair of a tibial plateau fracture.~      A secondary outcome will examine long-term pain control, range of motion, and functional~     status of these patients at their regular orthopedic clinic follow-up appointments. The same~     pain scores will be assessed, along with quadriceps strength and knee range of motion.~     Patients will complete the PROMIS Physical Function CAT and short Musculoskeletal Function~     Assessment, patient reported outcomes tools to evalute physical function.~      A teriary outcome will be to retrospectively examine postoperative pain scores and total~     opioid consumption for all tibial plateau fracture patients seen at the University of Utah~     for surgical repair in the past 10 years.~   "
106842|NCT02168946|"~     Carbavance™, (meropenem/vaborbactam) is being compared to the Best Available Therapy in the~     treatment of adults with selected serious infections due to Carbapenem Resistant~     Enterobacteriaceae~   "
106843|NCT02168933|"~     Psoriasis is a common skin disease, which affects 2-3% of the population. Up to two third of~     patients with psoriasis develop nail changes. These visible changes can be painful and~     disabling and are associated with social stigma. Most topical treatments are only partially~     effective. Systemic treatments can have serious side effects. Excimer laser is a form of~     targeted ultraviolet light therapy that has been successfully used to treat isolated~     psoriatic plaques on difficult to treat areas such as scalp or palms. The purpose of this~     study is to investigate efficacy of excimer laser for treatment of fingernail psoriasis.~     Sixteen patients with stable fairly symmetric fingernail psoriasis will be enrolled. After~     obtaining informed consent, an investigator will evaluate the severity of nail psoriasis in~     each hand using an objective score, called Modified Nail Psoriasis Severity Index (mNAPSI).~     In a random fashion, one hand will be treated with excimer laser and the other hand will~     receive sham treatment. During the treatments, patients will wear protective eyewear that~     does not permit them to see which hand receives active treatment and which hand receives sham~     treatment. Patients will be treated twice a week for 8 weeks. At weeks 8, 12, and16 the~     investigator who is blinded to the treatment assignments will re-evaluate the fingernails~     using mNAPSI score. Mean change from baseline mNAPSI score at weeks 8, 12, and 16 in hands~     treated with excimer compared to hands treated with sham will be measured. We will also~     measure patient's assessment of severity of nail disease and the pain or any adverse events~     associated with laser treatments. Given the slow growth rate of fingernails, the final~     evaluations will be performed at week 16. In summary, this is the first controlled study to~     evaluate efficacy of excimer laser in fingernail psoriasis. If found to be effective, excimer~     laser could be used as a safe, locally administered treatment for recalcitrant nail~     psoriasis.~   "
107084|NCT02165735|"~     The purpose of this study is to rigorously assess a program designed to empower patient~     living with HIV, to improve their health care and health, and to reduce disparities.~   "
106845|NCT02168907|"~     This phase I trial studies the side effects and best dose of CPI-613~     (6,8-bis[benzylthio]octanoic acid) when given together with bendamustine hydrochloride and~     rituximab in treating patients with B-cell non-Hodgkin lymphoma that has come back or has not~     responded to treatment. Drugs used in chemotherapy, such as 6,8-bis(benzylthio)octanoic acid~     and bendamustine hydrochloride, work in different ways to stop the growth of cancer cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Monoclonal antibodies, such as rituximab, may find cancer cells and help kill~     them. Giving 6,8-bis(benzylthio)octanoic acid with bendamustine hydrochloride and rituximab~     may kill more cancer cells.~   "
106846|NCT02168894|"~     The goal of this clinical research study is to learn if one acupuncture treatment approach is~     more effective than another in helping to relieve neuropathy in cancer patients.~   "
106847|NCT02168881|"~     This study is to compare between oral misoprostol in solution and vaginal dinoprostone in~     induction of labour in primiparous women with singleton pregnancy as regards efficiency and~     safety to both mother and fetus.~   "
106848|NCT02168868|"~     The purpose of this study is to analyze the immunological profile in blood of children with~     ASD.~   "
106849|NCT02168855|"~     The purpose of this study is to examine the effect of as-needed oral Nicotine Replacement~     Therapy (NRT) - 2 mg nicotine gum - for smoking cessation in non-daily, or intermittent,~     smokers, and to study the process of relapse in ITS, using Ecological Momentary Assessment~     (EMA).~   "
106850|NCT02168842|"~     The purpose of the study is to determine whether treatment with isradipine is effective in~     slowing the progression of Parkinson disease disability.~   "
106851|NCT02168829|"~     This trial is comparing medical approaches for stroke prevention in people who have atrial~     fibrillation (AF) and have undergone a successful procedure called ablation to eliminate or~     substantially reduce the arrhythmia. AF is normally associated with an increased risk of~     stroke which in many patients can be prevented with appropriate blood thinner therapy. This~     trial will compare a strategy of oral anticoagulant therapy after successful ablation to~     therapy with an aspirin per day.~   "
106852|NCT02168816|"~     The Infectious Diseases Society of America (IDSA) 2012 guidelines for the diagnosis and~     treatment of diabetic foot infections state that for the treatment of diabetic foot~     osteomyelitis No data support the superiority of any specific antibiotic agent or treatment~     strategy, route, or duration of therapy. Traditionally, osteomyelitis has been treated with~     a long course of intravenous antibiotics, generally six weeks. Oral antibiotics with high~     bioavailability and adequate bone penetration have been shown in published studies to be~     effective for the treatment of osteomyelitis.~      The investigators propose to conduct a prospective, single-center, randomized, open trial at~     Loyola University Medical Center (LUMC) comparing the efficacy of oral antibiotic therapy to~     intravenous (IV) antibiotic therapy for the treatment of diabetic foot osteomyelitis. The~     investigators hypothesize that oral antibiotic therapy is equivalent to IV antibiotic~     therapy.~      Bone/tissue cultures are obtained for all patients for clinical purposes and are sent to~     pathology for histologic examination and to the clinical microbiology laboratory for culture~     and susceptibility.~      Patients will receive six weeks of IV or oral antibiotic therapy depending upon their~     randomization group. Primary outcomes at six months clinical follow-up will include: (i) no~     evidence of bone infection and (ii) resolution of ulcer.~   "
106853|NCT02168803|"~     The main purpose of this study is to measure how much of the drug gets into the blood stream~     and how long it takes the body to get rid of it when given once a day for 12, 24, and 52~     weeks to participants with abnormal amounts of cholesterol and/or fat in the blood stream.~     Information about any side effects that may occur will also be collected.~      This study will also evaluate how the study drug reacts in the body when given once a day for~     12, 24 and 52 weeks and how the body responds and returns to normal when the treatment is~     complete. The relationship between study drug and the results from the how the study drug~     reacts in the body may be explored, if needed.~   "
106854|NCT02168790|"~     The investigators aimed at developing a technique to apply amniotic membrane to a diseased~     ocular surface without surgical intervention (sutureless amniotic membrane transplantation).~     This system needs to be concordant with laws and guidelines for the use of medical and~     pharmaceutical products.~   "
106855|NCT02168777|"~     Phase I: Determine the maximum tolerated dose of combination of Regorafenib with Refametinib~     through a dose escalation study, all tumor types that meet certain inclusion/exclusion~     criteria can be entered.~      After the recommended dose is determined, the Phase II portion of the study will evaluate~     tolerability and efficacy of the combination treatment in patients with breast cancer, lung~     cancer, or colorectal cancer, respectively.~   "
106856|NCT02168764|"~     The primary objective of the study is to demonstrate the safety and efficacy of SPG~     stimulation with the ATI Neurostimulation System when used to treat acute cluster attacks in~     chronic cluster headache patients.~   "
106857|NCT02168751|"~     Lung ventilation required for lung resection surgery induces a proinflammatory response~     including cytokine production and recruitment of leukocytes and macrophages in the lung~     associated with postoperative complications, mainly acute lung injury (ALI). The~     lung-protective ventilation has been shown reduce this inflammatory response and play a~     protective role against ALI, even though it is unclear the role of intravenous and~     inhalational anesthetic agents in immunomodulation of the inflammatory response during lung~     ventilation and its possible protective role against ALI. This study aims to determine the~     effect of anesthetic agents on markers of lung inflammation, the mechanisms of oxidative~     stress and ischemia-reperfusion, and assess the relationship between these mediators and~     postoperative morbidity defined as percentage of postoperative lung complications (ALI /~     ARDS, pneumonia and atelectasis), length of stay in ICU, hospital stay and mortality at 30~     days. The investigators hypothesis, based on results of our group in animal research, is that~     inhalants cause a lower proinflammatory response to intravenous agents for lung resection~     surgery.~      A clinical trial is design with two groups (propofol, sevoflurane) managed all with lung~     protective ventilation, in which the markers will be measured before and after one-lung~     ventilation in both lungs and in plasma before, during and after one-lung ventilation.~     postoperative lung complications, ICU and hospital stay and 30 days mortality.~   "
133268|NCT01822925|"~     To evaluate the effectiveness of DA-9801 at 300mg, 600mg, 900mg and placebo, in reducing pain~     in subjects with diabetic neuropathic pain compared to their baseline values.~   "
106860|NCT02168712|"~     Exercise therapy increase functional capacity improving the morbidity and mortality of~     patients with cardiovascular disease. Moderate continuous training is the best established~     training modality for this patients. However, a body of evidence has begun to emerge~     demonstrating that high intensity interval training obtained better results in terms of~     morbidity and mortality.~      The purpose of this randomized clinical trial was to determine the effect of two types of~     exercise training: moderate continuous training vs high interval training on functional~     capacity and quality of life as well as verify the safety in its application.~      We included 72 patients with coronary artery disease by assigning one of the training~     modality for 8 weeks. We analyzed cyclo-ergo-spirometry data, aspect related to quality of~     life as well as a record of adverse events.~   "
106861|NCT02168699|"~     Localizing the musculocutaneous nerve for neural blockade is crucial to achieve complete~     anesthesia of the forearm. However, in pediatric anesthesiology, the musculocutaneous nerve~     is unable to be blocked in up to 40-50% of cases when only neurostimulation is used, while~     there is limited information regarding ultrasound imaging of the musculocutaneous nerve in~     children.~      The aim of this prospective imaging study is to investigate whether musculocutaneous nerve is~     visualized in childhood with the use of ultrasound imaging or not. A secondary aim of this~     study is to assess the percentage of its visualization according to the age.~      Parental written informed consent is obtained from all participants. The children are divided~     into three groups according to their age: Group 1, with infants aged less than 12 months;~     Group 2, with toddlers and preschoolers; and Group 3, with school-aged children (6.5-12~     years).~      Children are placed in the supine position with the involved arm abducted at 90° and the~     elbow flexed at 90°. The linear probe of a portable ultrasound machine is placed at the~     axillary region, perpendicularly to the axillary artery. The musculocutaneous nerve is~     searched near the axillary artery (proximally) and its course is followed distally (into the~     coracobrachialis muscle). Its sonographic detection is recorded in these two sites, both~     proximally and distally.~   "
106862|NCT02168686|"~     The ADVANCE study is being conducted by Adverum Biotechnologies, Inc. as an open-label,~     multicenter, dose-escalation study in order to assess the safety and protein expression of~     ADVM-043 following intravenous or intrapleural administration.~   "
106863|NCT02168673|"~     Cigarette smoking is the major risk factor for developing chronic obstructive pulmonary~     disease (COPD). Patients with COPD have difficulty clearing mucus and debris from their~     airways. Even smokers who have not developed COPD may have difficulty clearing the airways.~     This is partly because smoking impairs the function of cilia, tiny hairs lining the airways~     that sweep out mucus to keep the airways clean. The investigators have found that smoking~     reduces the length of cilia, which may contribute to the worsened cilia function in smoking~     and COPD. This is true even in smokers who show no signs of lung disease. The investigators~     believe that smoking affects levels of genes in lung cells, resulting in shorter cilia.~   "
106864|NCT02168660|"~     Vitamin D deficiency is extremely common in obese youth. In our obese population followed in~     the Endocrinology clinic at CMC, vitamin D levels were inversely correlated with a measure of~     insulin resistance. We propose to show that correction of vitamin D levels in obese children~     and adolescents improves their insulin sensitivity. Obese youth presenting to the Center for~     Obesity and its Consequences on Health (COACH) clinic will be randomized to receive either~     the most recent Institute of Medicine (IOM) recommendations of minimum D3 dose of 600 IU/day~     (1), or receive higher doses of D3 such that the blood levels of vitamin D will be brought to~     a target level in either the low part or high part of the normal range. The goal is to~     determine if correction of vitamin D deficiency will improve insulin sensitivity in this~     group. Secondary goals include determining whether correction of vitamin D deficiency in~     obese adolescents and children results in less weight gain, and determining the amount of D3~     required to correct vitamin D levels in this population.~      Our specific hypotheses are as follows:~      Hypothesis #1 Obese youth treated with Vitamin D3 who achieve low-normal 25-OHD levels (30-50~     ng/mL) or high-normal 25-OHD levels (60-80 ng/mL) will have improved insulin resistance, as~     measured by HOMA-IR, compared to those individuals with deficient 25-OHD levels (< 30 ng/mL).~      Hypothesis #2 Subjects with a higher BMI will have higher Vitamin D dose requirements than~     current IOM recommendations of 600 IU/day and will take a longer period of time to reach~     target 25-OHD levels.~      Hypothesis #3 Subjects with normal 25-OHD levels will demonstrate less weight gain compared~     to subjects on the control arm.~   "
106865|NCT02168647|"~     Multiple studies have demonstrated a very low prevalence of women meeting physical activity~     and weight gain recommendations during pregnancy. The aim of this study is to provide a~     lifestyle intervention to increase physical activity, reduce carbohydrate intake, prevent~     excessive gestational weight gain, decrease postpartum weight retention, and improve mental~     well-being compared to usual care using a randomized controlled design in pregnant women.~     Participants in the intervention group will receive behavioral lifestyle counseling and take~     part in monthly one-on-one visits with a registered dietitian (RDN) from approximately week~     14 of their pregnancy to child birth. Participants in the usual care group (control) will~     not receive any lifestyle counseling. Data collected from this group will be used to compare~     the effectiveness of the lifestyle intervention. Unlike many studies examining diet and~     physical activity factors alone, this study evaluates additional psychosocial factors such as~     psychological health, self-efficacy, competence, motivation and barriers that may influence~     excessive gestational weight gain. In addition, the Self-Determination Theory framework will~     be used to measure how motivation and motivational interviewing strategies can help explain~     changes in volitional behavior.~   "
106866|NCT02168634|"~     Hypertrophic scar, a disfiguring tissue reaction to trauma, occurred in around 20 % of the~     population. The patients with hypertrophic scar usually seek medical assistance not just for~     the annoying appearance but mostly due to the intractable itchiness. There have been a~     variety of effective methods to alter the appearance of the scar. However, the treatments for~     itching from hypertrophic scar are scarce. In 2009, P.Gazerani used Botox to treat~     histamine-induced itch with favorable results. In the clinical setting, however, the efficacy~     of Botox to treat itch from hypertrophic scar was yet to be proven. Therefore, the goal of~     this study is to conduct a randomized controlled trials about using Botox to treat itch from~     hypertrophic scar.~   "
134179|NCT01811004|"~     The Purpose of the study is to evaluate the 1440nm Laser Assisted Selective Photothermolysis~     vs. Botulinum Toxin or miraDry® Microwave Thermolysis For Treatment of Axillary~     Hyperhidrosis.~   "
106867|NCT02168621|"~     Treatment directed towards the control of periodontal infections is to about 90% non-surgical~     procedures. There is evidence from a large number of randomized controlled studies that the~     efficacy in terms of clinical outcomes of a full-mouth ultrasonic debridement approach (FMUD)~     is comparable to that of traditional section-wise scaling and root planing (SRP). A~     hypothesis for the current effectiveness study is that comparable clinical effects will be~     obtained with the FMUD approach as with conventional section-wise SRP, but with significantly~     more favourable patient-centred and health-economic outcomes.~      This randomized study involves about 100 professionals (dental hygienists) and more than 1000~     patients at 45 dental clinics in the Vastra Gotaland Region, Sweden. The project not only~     evaluate treatment effects in terms of pertinent clinical outcomes, it also has a strong~     focus on patient-centered measures - patient-reported experience measures (PREM) and~     patient-reported outcome measures (PROM) - as well as health-economics.~   "
106868|NCT02168608|"~     Remote ischemia precondition could protect the liver from ischemia reperfusion injury in~     patients undergoing hepatectomy.~   "
106869|NCT02168595|"~     The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of single~     ascending IV doses of GMI-1271 in healthy adult subjects.~   "
106870|NCT02168582|"~     This is an observational study that aims to characterize individual response of patients~     getting physical therapy for chronic non-specific low back pain.~      Participants will be classified based on a questionnaire and motor tests to investigate~     whether individual improvement after physical therapy may be predicted. These observations~     may help to decide which should be the preferred treatment offered.~   "
106871|NCT02168569|"~     This is a classical in vivo clinical trial, following World Health organization's~     recommendations, ran as a multisite study within Mozambique trying to assess the efficacy and~     safety in 5 sites of the two oral ACTS artemether-lumefantrine (AL) and~     Amodiaquine-Artesunate (AQ-AS), first and second line treatment for malaria in mozambique,~     respectively, for the treatment of uncomplicated malaria in children aged<5 years.~   "
106872|NCT02168556|"~     This is a randomized controlled trial to determine if music, a video, or standard of care~     will decrease anxiety in patients undergoing urodynamic testing.~   "
106873|NCT02168543|"~     -  Locally delivered Alendronate (ALN) have potent inhibitory effect on bone and increases~          new bone formation in chronic periodontitis patients~        -  Till date no study has reported the effect of local delivery of ALN in chronic~          periodontitis patients among smokers. Hence the aim of this study is to investigate the~          clinical and radiographic effects of locally delivered ALN as an adjunct to the non~          surgical treatment in smoker chronic periodontitis patients.~   "
106874|NCT02168530|"~     This is a randomized, multicenter, double-blind, placebo-controlled, parallel-group study of~     vismodegib in patients with IPF. Eligible patients will be randomized in a 2:1 ratio to one~     of two treatment arms: vismodegib or placebo. The duration of treatment will be 52 weeks.~     Study drug will be administered daily by the oral route. An 8-week safety follow-up period is~     included for all patients who receive at least one dose of study drug.~   "
106875|NCT02168517|"~     The overall aim of the study is to investigate if patients with musculoskeletal chronic pain~     have reduced semen quality in comparison with age matched healthy controls. Secondly, the aim~     is to investigate whether overweight with or without chronic pain are related to reduced~     semen quality. We will investigate semen quality in obese chronic pain patients, normal~     weight chronic pain patients and in obese and normal weight healthy controls.~   "
106876|NCT02168504|"~     A simple, painless and reliable method to detect Parkinson's disease at an early stage is~     very important to patients, doctors and researchers. Doctors want to help patients early, and~     scientists want to select patients for their research who will help in development of better~     drugs. We hope that the changes in electrical activity of hand muscles during handwriting~     will help in early detection of this disease.~   "
106877|NCT02168491|"~     Premixed insulin-based therapy is a standard insulin treatment strategy in Austria. The~     widespread use of premixed insulin is explained by high acceptance by health care~     professionals and patients due to one single product and flexible number of injections (1-3~     daily) which covers the demand in controlling fasting and postprandial glucose excursions of~     most patients with diabetes. However, the use of pre-mixed insulin frequently leads to a high~     insulin demand and consequently weight gain and an increased risk of hypoglycemia. Hence,~     achieve good metabolic control in these patients remains a major challenge.~      For those patients, the approach to treatment intensification without facing the typical~     risks of insulin treatment (hypoglycemia and weight increase) is of major importance. One, so~     far not exploited option may be the BIT-strategy: Basal insulin in combination with~     incretin-based therapy.~      Pathophysiologically basal insulin inhibits glucose production in the liver, decreases~     hepatic insulin resistance and improves the function of beta cells in the postprandial state~     by discharge of fasting insulin secretion. During further diabetes progression steadily~     increasing HbA1c levels - despite good fasting blood glucose control - indicate the need for~     additional intervention of meal-related glucose excursions. In this stage of type-2 diabetes~     basal insulin can be combined with prandial (short-acting) insulin or prandial GLP-1 receptor~     agonists. However, regarding important safety parameters: risks of hypoglycemia and weight~     gain in the long-term treatment GLP-1 receptor agonists are beneficial.~      Lixisenatide is a novel GLP-1 receptor agonist with a pronounced postprandial (PPG) effect~     which fits with basal insulin mode of action primarily focused on fasting blood glucose~     reduction.~      Therefore 10 patients (both gender) under treatment with premixed insulin (2-3 times daily)~     and HbA1c>7% will be switched to basal insulin glargine (Lantus, once daily) and GLP-1~     receptor agonist Lixisenatide (Lyxumia, once daily). The investigators hypothesize that~     switching from a therapy based on premixed insulin to a simple, once daily administered~     combination of basal insulin plus a GLP-1 receptor agonist in patients with type-2 diabetes~     not achieving therapeutic target (HbA1c>7%) is clinically feasable in an out patient setting~   "
106878|NCT02168478|"~     A 48 hour patch test performed in healthy volunteers to determine the presensitization~     (pre-existing allergy) of Neo-Synalar (neomycin sulfate 0.5%(0.35% neomycin base),~     fluocinolone acetonide 0.025%) Cream . Subjects also receive a positive control (Sodium~     Lauryl Sulfate) and a negative control (Saline).~      The primary objective of this study is to determine if any subjects exhibit an allergic~     reaction which may be indicative of a pre-existing sensitization.~   "
106879|NCT02168465|"~     1. Design and develop web-based self-management intervention to improve catheter-related~          outcomes and quality of life in people with spinal cord injury (SCI).~        2. Conduct a pilot study to assess the feasibility (i.e., acceptability and usability of~          the website application) and preliminary effectiveness of this new self-management~          intervention.~        3. Develop and test the reliability of new/modified measures (intermittent catheter~          self-efficacy and self-management).~   "
107312|NCT02162758|"~     This study is designed to evaluate the effect of dexlansoprazole once daily (QD) and twice~     daily (BID) dosing on the recurrence of intestinal metaplasia (IM) in participants who~     achieved complete eradication of Barrett's esophagus (BE) with high-grade dysplasia (HGD)~     following radiofrequency ablation (RFA).~   "
106880|NCT02168452|"~     This study aimed to evaluate the feasibility of dual sentinel node staining method using~     mixture of indocyanine green(ICG) and radioisotope (RI) in breast cancer patients who receive~     neoadjuvant chemotherapy.~      Over the past few years, several studies have found using methylene blue, isosulfan blue,~     indocyanine green or radioisotope alone by detection method had several disadvantages.~      In this study we expects using mixture of indocyanine green (ICG) with radioisotope (RI) has~     potential to improve sentinel lymph node (SLN) mapping in breast cancer patients who receive~     neoadjuvant chemotherapy.~   "
106881|NCT02168439|"~     The objective of this research study is to show superiority of intranasal dexmedetomidine to~     intranasal midazolam as anxiolysis prior to pediatric laceration repairs.~   "
106882|NCT02168426|"~     The purpose of the study is to evaluate the efficacy of Seprafilm and guardix in reducing the~     incidence of bowel obstruction and to evaluate the incidence of all serious adverse events~     (SAEs) associated with the use of Seprafilm and guardix occurring within 30 days~     postoperatively.~   "
106883|NCT02168413|"~     This study has two main goals :~        -  to develop the cortcial excitbality (CE) measurement methodology using coupling between~          transcranial magnetic stimulation (TMS) and physiological recordings such as~          electroencephalography (EEG) and electromyography (EMG),~        -  to automatize these measurements using robotized TMS.~      Assessing CE is a preliminary and crucial step in any TMS protocol, in either fundamental or~     clinical research. It is an important indicator which determine the stimulation power applied~     on the cortical target during the TMS experiment, or during the rTMS cure (patients). CE is~     in general measured on the motor cortex using EMG activity as the main indicator of the~     system's response, whatever the real cortical target is located. The present study thus~     propose to generalize this measurement on other cortical areas in link with the actual~     targets, and using other external recordings such as EEG. Moreover, as neuronavigation~     systems significantly improved TMS precision in the past years, CE measurements could~     significantly gain to become fully automatized using robotized TMS.~   "
106884|NCT02168400|"~     Long-term abstinence from alcohol is supported by a compensatory mechanism in functional~     brain connectivity, a potential brain biomarker that could be an intervention target. These~     findings provide a compelling case to explore whether this brain biomarker can be modulated~     to enhance patients' ability to remain abstinent. There is a need to investigate methods that~     can be used to increase functional brain connectivity. The overall objective of this proposal~     is to enhance brain functional connectivity in short-term abstinent alcoholics as a~     therapeutic intervention that supports abstinence.~   "
106885|NCT02168387|"~     The purpose of this study is to evaluate whether a therapy that uses a machine called a~     continuous high frequency oscillator (CHFO) is more successful at removing mucus than~     medications that thin out the mucus.~   "
106886|NCT02168374|"~     This study assessed the clinical performance of a resin-modified glass ionomer cement~     containing different concentrations of chlorhexidine digluconate and doxycycline hyclate.~   "
106887|NCT02168361|"~     Randomized trial of Hepatitis C-genotype 1-infected patients with compensated cirrhosis~     comparing the standard of care (Peginterferon/Ribavirin/Sofosbuvir) versus the off-label~     combination of simeprevir+ sofosbuvir without Ribavirin.~   "
106888|NCT02168348|"~     The investigators set out to determine whether malnutrition delayed healing of foot lesions~     in diabetic patients.~   "
106889|NCT02168335|"~     Gingivitis is defined as inflammation of the gingiva. It is a common disease that is~     prevalent in both children and adults, and in both genders . The primary cause of gingivitis~     is plaque accumulation due to poor oral hygiene; however, gingivitis may result from many~     varied aetiological factors. Gingivitis is characterized by red, swollen, spongy gums that~     bleed easily . Current conventional treatment of gingivitis involves removal of plaque and~     the use of an antimicrobial mouthwash. Mouthwashes containing chlorhexidine gluconate are~     most commonly prescribed, however these have certain adverse effects. Ora-saltsTM is a~     commercially available mouthwash composed of natural sea salt, Arnica montana 30 centesimal~     (C), Echinacea angustifolia 30C, Staphisagria 30C, Phosphorus 30C, Hepar sulph 30C, cinnamon~     and liquorice. To date there is no research on the use of OrasaltsTM in the treatment of~     gingivitis. The aim of this study is to determine the efficacy of OrasaltsTM in the treatment~     of gingivitis using the Modified Gingival Index (MGI) and the Quantitative Gingival Bleeding~     Index (QGBI).~   "
106890|NCT02168322|"~     Membrane modifecation:~      Guided tissue membrane perforations may serve as a more biologic scaffold that could allow~     for the free passage of biologic mediators from the periosteum and overlying gingival~     connective tissue into the periodontal defects.~      Study hyposethis:~      To test this hyposthesis, this study was designed to evaluate levels of vascular endothelial~     cell growth factors and platlet derived growth factors in gingival crevicular fluid (GCF)~     during the early stages of healing for localized intrabony defects treated with modified~     perforated membranes (MPMs), occlusive membranes (OMs) as compared to open flap debridement~     control (OFD).~      Methods: Thirty non-smoking patients with severe chronic periodontitis participated in this~     prospective, randomized and single blinded trial. Each patient contributed one interproximal~     defect that was randomly assigned to experimental modified perforated membrane group (10~     sites), occlusive membrane group (10 sites) or open flap debridement control (10 sites).~     Plaque index, gingival index, probing depth (PD), clinical attachment level (CAL) and the~     intrabony depth of the defect (IBD) were measured at baseline for patients enrollment.~     Gingival crevicular fluid (GCF) samples were collected on day 1 and 3, 7, 14, 21, and 30 days~     after therapy. The primary outcome variable was the change in VEGF and PDGF-BB levels for~     sites treated by MPMs or OM compared to that of the OFD treated cases.~   "
106891|NCT02168309|"~     This study's aim is to determine whether oral extended release nifedipine is superior to oral~     labetolol for the management of postpartum severe hypertension, specifically time to achieve~     goal blood pressure, and shortening hospital stay. Our hypothesis is that oral extended~     release nifedipine is superior to oral labetolol for achieving goal blood pressure in the~     postpartum period.~   "
106892|NCT02168296|"~     The study is designed to explore the pharmacokinetics of a Plant-based ingredient in two~     different matrices, at different dose levels.~   "
107334|NCT02162472|"~     The aim of this study is to determine if videocapillaroscopy could be used as an objective~     and reliable method to assess psoriasis severity and to document improvement during treatment~     by measuring changes in vascular features.~   "
106893|NCT02168283|"~     INTRODUCTION Peritoneal dialysis (PD) is a life-saving treatment for end-stage renal disease~     patients. However, cardiovascular disease remains the major cause of morbidity and mortality~     in PD patients. It is now realized that chronic asymptomatic intravascular hypervolemia is an~     important cause of cardiovascular disease in PD patients.~      OBJECTIVES To determine the effects of treating asymptomatic fluid overload on blood~     pressure, hospitalization and cardiovascular morbidity in PD patients.~      HYPOTHESIS The investigators hypothesize that treating asymptomatic fluid overload could~     improve the clinical outcome of PD patients.~      DESIGN & SUBJECTS This is an open label randomized control trial. The investigators plan to~     recruit 60 PD patients with asymptomatic fluid overload, defined as overhydration (OH) ≥ 2~     liters. Patients will be randomized to active fluid management (treatment arm) or~     conventional management (control arm).~      STUDY INSTRUMENTS Overhydration will be identified by bioimpedance spectroscopy.~      INTERVENTIONS For the treatment arm, active fluid management includes dietary counseling,~     diuretics, and intensive dialysis regimen. For the control arm, patients will only receive~     dietary counseling. Patients will be followed for one year.~      MAIN OUTCOME MEASURES Blood pressure control, number of hospital admission and duration of~     hospitalization for all cause, and hospitalization for cardiovascular disease during the~     study period.~      DATA ANALYSIS Blood pressure control will be compared by Student's t test. Hospitalization~     data will be compared by non-parametric Mann Whitney U test.~      EXPECTED RESULTS The study will determine the benefit of treating asymptomatic fluid overload~     in PD patients.~   "
106894|NCT02168270|"~     This phase I trial studies the side effects and best dose of ascorbic acid when given~     together with temozolomide in treating patients with high-grade glioma that has come back.~     Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth~     of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Ascorbic acid contains ingredients that may prevent or slow the growth~     of high-grade gliomas. Giving temozolomide with ascorbic acid may kill more tumor cells.~   "
106895|NCT02168257|"~     The purpose of this study is to determine if the RAM cannula is as effective as conventional~     binasal prongs to deliver CPAP to low birth weight infants with respiratory distress.~   "
106896|NCT02168244|"~     Injectable biologic drugs are used as a treatment of psoriasis. These injections can~     sometimes be associated with pain. In this study the investigators aim to reduce the pain by~     applying heat or ice to the skin 2-3 minutes before injecting the drug, and to compare the~     pain to injection without any heat or ice.~   "
106897|NCT02168231|"~     Incisional hernia is the most frequently seen long term complication in surgery causing much~     morbidity and even mortality in patients. Despite studies on the optimal closing technique~     for laparotomies, the risk for incisional hernia after midline incision remains about 5-20%.~     It has been established that implementing a mesh reduces recurrence of the incisional hernia~     but still the results of repair are often disappointing. Incisional hernias can become~     increasingly complex due to complicated abdominal wall defects caused by a disturbed anatomy,~     fistulas, burst abdomen, wound and mesh infections. In these cases it is not save to repair~     the incisional hernia by means of a synthetic mesh and other augmentation tools need to be~     implemented.~      In the recent years the use of biological meshes has been gaining popularity. Recent reports~     of the use of collagen-based prosthesis have suggested that they support new vessel growth,~     do not excite a significant foreign body reaction, form fewer adhesions, are well~     incorporated into host tissues with minimal wound contraction, and can be used in grossly~     contaminated wounds with fewer infective complications. Biologic meshes are harvested from a~     source tissue and processed for medical use but they vary widely in their processing methods.~     They include tissues of human or animal origins, both chemically cross-linked and non~     cross-linked processes, and submucosal, pericardial, or dermal tissue sources. Current~     studies investigating the effectiveness of these meshes are small and have short periods of~     follow-up. These shortcomings can be explained to high cost of the meshes and unclear~     indication when to use a biological mesh.~      The aim of this study is to investigate the short and long term effects of the Strattice~     biological mesh. The investigators will also inquire why a biologic mesh was used and what~     the direct and indirect costs were.~   "
106898|NCT02168218|"~     This study aims at assessing the hypothesis that dietary protein content is a major factor~     regulating lean body mass gain and energy expenditure during overfeeding, and thus long term~     body weight gain~      To test this hypothesis, healthy normal weight male and female subjects will before and after~     a 7-day hypercaloric, high-sucrose diet (+40% excess energy as sucrose) and either a low (5%~     total energy) or a high (20% total energy) protein intake. Each subject will be studied with~     both low- and high protein diets according to a randomized, crossover study. On each occasion~     the following measurements will be done in basal conditions (after 2-day isoenergetic,~     controled diet) and at the end of the 7-day overfeeding:~        -  whole-body protein turnover, oxidation and synthesis in fasting conditions and fed~          conditions (13C-labelled leucine)~        -  intrahepatic and intramuscular fat concentration (1H-Magnetic Resonance Spectroscopy)~        -  Energy metabolism in fasted and fed conditions (indirect calorimetry)~        -  plasma concentration of glucose, non-esterified fatty acids, total triglyceride,~          very-low density lipoprotein (VLDL)-triglyceride, insulin, glucagon, growth hormone~          (GH), insulin-like growth factor 1 (IGF1), insulin-like growth factor binding protein~          (IGFBP) 1,2 and 3 in fasting and fed conditions The effects of high-protein and~          low-protein sucrose overfeeding on whole body protein synthesis will be compared using~          two-way ANOVA; relationships between changes in whole body protein synthesis on one~          hand, and intrahepatic/intramuscular fat concentrations, total energy expenditure, and~          plasma concentration of metabolic variables on the other hand, will be evaluated by~          linear regression analysis~   "
106899|NCT02168205|"~     This study will evaluate the effect of food and smoking on healthy older subjects taking~     pomalidomide.~   "
106900|NCT02168192|"~     The purpose of this study is to assess the utility of training in Breaking Bad News (BBN)~     skills. We hypothesize that given little or no formal training in breaking bad news,~     obstetric providers will benefit from a curriculum of teaching breaking bad news techniques,~     but will benefit more from a simulation teaching technique than from a lecture in breaking~     bad news techniques.~      The investigators also hypothesize that providers who have undergone breaking bad news~     simulation will receive improved scores after the simulation debriefing compared to their~     pre-simulation scores, and their improvement with be greater than the control group.~   "
106901|NCT02168179|"~     This pilot clinical trial studies KeraStat Skin Therapy in treating radiation dermatitis in~     patients with newly diagnosed stage 0-IIIA breast cancer. Radiation dermatitis is an itchy,~     painful skin rash that can occur following treatment with radiation. KeraStat Skin Therapy~     may be a better treatment for radiation dermatitis.~   "
134180|NCT01810991|"~     The purpose of this study is to evaluate the safety and efficacy of the Nd:YAG 1440 nm~     wavelength laser for the treatment of primary hyperhidrosis of the axilla.~   "
106902|NCT02168166|"~     Cognitive remediation (CR) therapies refer to a number of recent developments to use~     behavioural strategies to improve neurocognitive abilities and improve everyday functioning~     in mental disorders such as schizophrenia, bipolar disorder, and depression. In this study,~     we aim to examine whether we can observe CR effects on measures of neuroplasticity,~     cognition, and functioning when using a rigorous control comparison group. We hypothesize~     that the active group will exhibit improvements in executive functioning composite scores,~     improved EEG theta-gamma frequency modulation, and increased EEG alpha power compared to the~     placebo group.~   "
106903|NCT02168153|"~     This study is a randomized controlled trial designed to evaluate changes in reaction times~     (RTs) and response times (RespTs) following chiropractic treatment compared to controls in~     the Special Forces Qualified (SFQ) population, including Special Operation Forces who are~     part of the 160th SOAR regiment on flight status.~   "
106904|NCT02168140|"~     This phase I trial studies the side effects and best dose of CPI-613 when given together with~     bendamustine hydrochloride in treating patients with relapsed or refractory T-cell~     non-Hodgkin lymphoma or Hodgkin lymphoma. CPI-613 may kill cancer cells by turning off their~     mitochondria, which are used by cancer cells to produce energy and are the building blocks~     needed to make more cancer cells. By shutting off mitochondria, CPI-613 may deprive the~     cancer cells of energy and other supplies needed to survive and grow. Drugs used in~     chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth~     of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Giving CPI-613 with bendamustine hydrochloride may kill more cancer~     cells.~   "
106905|NCT02168127|"~     The purpose of this six month, open-label study is to evaluate the long-term safety and~     efficacy of PRC-063 in adults and adolescents with ADHD.~   "
106906|NCT02168114|"~     The purpose of this research study is to determine the potential of Optical Imaging~     techniques to detect muscle damage in boys with Duchenne Muscular Dystrophy and unaffected~     exercised muscle. Healthy subjects will undergo two different exercises in opposite forearms~     before any imaging techniques are performed. Boys with Duchenne Muscular Dystrophy will only~     undergo the imaging techniques without exercise.~   "
106907|NCT02168101|"~     The purpose of the study is to determine whether MLN9708 is effective as maintenance therapy~     following allogeneic stem cell transplant in patients with high-risk multiple myeloma.~   "
106908|NCT02168088|"~     This study seeks to incorporate genetic testing into the postmortem examination of cases of~     sudden unexplained death.~   "
106909|NCT02168075|"~     Mannitol is widely used in patients with elevated intracranial pressure. In neurosurgical~     field, especially in large size or with brain edema, it is necessary to decrease brain volume~     to facilitate surgical approach. In general, 0.25 -1.5g of mannitol per kilogram has been~     known to decrease ICP effectively. But there are some debates in regard to appropriate dose~     of mannitol.~   "
106910|NCT02168062|"~     This pilot partially-randomized phase II trial studies how well Supportive Therapy in~     Androgen Deprivation (STAND) clinic works in improving health outcomes and managing side~     effects in patients with prostate cancer. Individualized counseling regarding exercise and~     dietary habits may help improve patient understanding, satisfaction, and overall lessen~     adverse impact on quality of life caused by androgen deprivation.~   "
106911|NCT02168049|"~     The investigator goal is to test a new device to see if it can provide continuous and~     simultaneous monitoring of heart and lung function.~   "
106912|NCT02168036|"~     The purpose of this protocol is to obtain biologic materials from the mediastinal lymph nodes~     from patients with lung disease and mediastinal lymph node involvement in order to: (1)~     develop a better understanding of the cause and development of lung disorders involving the~     mediastinal lymph nodes; (2) identify biologic parameters that help diagnose and predict the~     behavior of human lung diseases; and (3) identify individuals who will be suitable candidates~     for other protocols such as those involving investigational new drugs.~   "
106913|NCT02168023|"~     Surgical site infections (SSIs) constitute an important medical and socioeconomic problem~     worldwide. Despite the fact that the risk factors for SSIs were identified and the~     continuously increasing medical knowledge in the fields of tissue engineering, molecular~     biology and microbiology facilitated the development of numerous new recommendations and~     methods for management, in many cases the available options for successful treatment of~     post-operative wound infections remain limited. Non-treated or inappropriately treated SSIs~     often lead to necrosis of the surrounding tissues, wound dehiscence, formation of fistulas,~     or become sites of origin for systemic infections. Patients are exposed to risk of further~     complications and hospitalization time extends resulting in increased total treatment costs.~     Treatment prolongation affects also the quality of life and psychosocial functioning of~     patients with impaired wound healing. Considering the arguments above, appropriate prevention~     and management of infected post-surgical wounds is currently one of the priorities for the~     majority of invasive medical disciplines.~      Obstetrics constitute a field of medicine in which the issues associated with wound healing~     are particularly relevant. According to the literature data wound infections occur in~     approximately 1.8-11.3% of women undergoing caesarean section.~      Dialkylcarbamoyl chloride (DACC) is a fatty acid derivative that irreversibly binds~     microorganisms to the dressing fibres as a result of hydrophobic interaction. As the~     mechanism of DACC action is solely physical no chemical agents are released into the wound~     bed and the dressing could be safely used by women during puerperal period.~      The purpose of this randomized controlled study is to compare the effect of DACC impregnated~     dressing and standard surgical dressing in the prevention of SSIs in adult women following~     caesarean section. This study will also evaluate pre-, peri- and postoperative risk factors~     of SSIs and analyze health economics of DACC impregnated dressings for prevention of~     post-cesarean wound infections.~   "
106914|NCT02168010|"~     The study examines the efficacy and safety of Analgecine in the treatment of chronic pain in~     patients with low back pain for 3 months after surgical treatment. It is a randomized,~     placebo-controlled, double blind, multi-center phase III clinical trial. Patients with~     chronic low back pain for 3 months after surgical treatment is recruited (age between 18 and~     70; pain visual analysis scale (VAS) between 3 and 8). After randomization, subjects are~     divided into 3 groups: 1) Treatment with Analgecine (Experiment group); 2) Treatment with~     Neurotropin (positive control group); 3) Placebo group. Subjects will be undergone 4~     measurement time points on day 0, 7, 14, and 21. In each time points, subjects are required~     to score their pain with pain VAS and to have regular blood, urine, and renal/liver function~     tests. The changes of the pain VAS at day 21 are compared between groups.~   "
106915|NCT02167997|"~     To compare the safety and efficacy of treating small aneurysms with coils specially designed~     for small aneurysms to historically reported rates of safety and efficacy for the treatment~     of larger aneurysms.~   "
137265|NCT01770535|"~     The purpose of the study is to understand why there are differences between individuals in~     the way they respond to paclitaxel chemotherapy.~   "
106916|NCT02167984|"~     Esophageal dysmotility due to immaturity could promote impaired bolus transit during~     esophageal swallow events,thus influencing gastroesophageal reflux (GER) clearance.~      Aim of this study was to describe esophageal bolus transit characteristics during swallow and~     to evaluate the relationship between esophageal swallow (ES) and GER in newborns with~     gastroesophageal reflux disease symptoms using multichannel intraluminal impedance.~      The simultaneous analysis of swallow and GER events in newborns undergone MII/pH monitoring~     could provide useful information to better understand the physiopathology of gastroesophageal~     reflux disease (GERD) and could help clinicians to identify newborns with prolonged~     esophageal clearance time, making the recommendations for further tests and the therapeutic~     approach more accurate~   "
106917|NCT02167971|"~     The purpose of this study is to determine whether repetitive Transcranial Magnetic~     Stimulation (rTMS) is effective in the cognitive rehabilitation of patients with diffuse~     axonal injury(DAI) after Traumatic Brain Injury(TBI).~   "
106918|NCT02167958|"~     The purpose of this study is to determine whether stem cells collected from a donor's blood~     stream will be as safe and effective as using bone marrow collected from a donor's pelvic~     bone.~   "
106919|NCT02167945|"~     The purpose of this study is to evaluate Long-term Outcomes following treatment with~     ABT-450/r/ABT-267, ABT-333 with or without RBV in Adults With Genotype 1 Chronic Hepatitis C~     Virus (HCV) Infection~   "
106920|NCT02167932|"~     This study will look at whether or not participating in a physical activity intervention~     during chemotherapy for breast cancer can prevent a marker of aging called p16 from having a~     large increase after chemotherapy.~   "
106921|NCT02167919|"~     Purpose: To evaluate the efficacy of prostatic artery embolization (PAE) in patients with~     benign prostatic hyperplasia (BPH) and refractory lower urinary tract symptoms (LUTS) in~     decreasing the volume of the prostate gland.~      Participants: Study participants will be recruited from UNC Urology clinics as well as~     referring providers. We will include 15 men who are experiencing LUTS not controlled by~     medication with estimated prostate gland weight between 80 and 150 grams.~      Procedures (methods): Enrolled patients will undergo the standard work-up for a surgical~     prostate procedure. In addition, the patient's arteries will be evaluated with a pelvic CT~     angiogram. Then, patients will undergo prostatic artery embolization. Follow up visits will~     be scheduled at 1, 3, 6, and 12 months after the procedure.~      At the end of the follow-up period, if reduction in prostate gland size has made the patient~     eligible for transurethral therapy, they may proceed to such procedure or elect to undergo no~     further surgical procedure, depending on residual symptoms. Similarly, if insufficient gland~     size reduction has occurred, the patient may elect to pursue OP or no further procedure if~     they are no longer bothered by LUTS.~   "
106922|NCT02167906|"~     Patients affected by osteoarthritis (OA) have an increase overall mortality compared to the~     general population, mainly due to cardiovascular diseases. OA patients without cardiovascular~     risk have a 10 years cardiovascular events higher of around 15-30 %. Although the molecular~     mechanisms are still not well known, the structure and function of the vessel wall can be~     affected by several inflammatory and metabolic parameters during OA.These functional and~     structural changes of the arterial wall leads to arterial stiffness, measured by the~     pulse-wave velocity (PWV). PWV is the most widely used technique to assess arterial stiffness~     and has been shown to have predictive value for morbidity and mortality. In our study, we~     planned to compare arterial stiffness in OA patients with healthy subjects.~   "
106923|NCT02167893|"~     The purpose of this survey is designed to evaluate the efficacy and safety of long-term use~     (96 weeks) of leuprorelin acetate SR 11.25 milligram (mg) injection kit (Leuplin SR 11.25 mg~     injection kit) in prostate cancer participants in daily medical practice.~   "
106924|NCT02167867|"~     The purpose of this study is to test the ability of the lay end user to understand the~     information contained in the User's Guide; to correctly identify patients who are suitably~     qualified to receive treatment; and to correctly administer the treatment with the Erchonia~     ZERONA® Z6 for circumference reduction of the waist, hips and thighs in an over-the-counter~     setting.~   "
106925|NCT02167854|"~     This is a Phase I study. The purpose of this study is to determine what is the best dose of~     the study drug BYL719 in combination with the study drug LJM716 and traztuzumab (Herceptin®).~     The study will test the safety of the combination of these three drugs, and to find out the~     effects, good and/or bad, that these three drugs have on the patient and breast cancer.~   "
106926|NCT02167841|"~     Background: The incidence of breech presentation in pregnant women is 4%. The situation can~     be treated by two methods. The first is a version of the fetus from breech presentation to~     head presentation, which can be performed in several ways, such as, an action called EXTERNAL~     CEPHALIC VERSION as well as the Knee-Chest position by the pregnant mother and the second is~     a cesarean section. In this study we wish to investigate if the Knee-Chest position is as~     effective as the ECV action and as a result to decrease the need for ECV.~      Hypotheses: According to our assumption, the Knee-Chest position can reduce the need for the~     ECV action.~      Objectives: Investigate whether daily Knee-Chest position is as effective as ECV.~      Methods: The investigators will conduct a randomized clinical trial study. Every pregnant~     woman in a breech presentation with a singleton between weeks 28-32 will be randomly assigned~     into one of two groups. In the first group the women will perform daily the Knee-Chest~     position between weeks 32-37. In week 37 the investigators will check via ultra sound if~     there was a successful version (if not, the woman would go to ECV) in the second group we~     will perform ECV without doing maternal Knee-Chest position before. Every woman will fill a~     questionnaire which includes gynecological history and details regarding the degree of~     persistence and performance of the activity. At the end of this process the investigators~     will analyze the results and will come to the conclusions.~      Significance: With ECV there are number of risks and complications such as fetal distress,~     placental abruption, rupture of membrane, amniotic fluid embolism or damage to the uterus.~     The frequency of these complications is 1%-2%. If it is discovered that the Knee-Chest~     position is effective as the ECV action, the investigators will recommend every patient to~     persist with this position and avoid the ECV action and the risks it entails.~   "
106947|NCT02167568|"~     Corpus callosum agenesis or dysgenesis (CCA) is a major brain malformation (˜1/4000 births)~     presently diagnosed by prenatal ultrasonography. In about half of the cases, CCA is~     associated with other anomalies (complex CCA), which usually leads to medical abortion.~     Syndromes including a CCA are many (hundreds), most of which are also associated with~     intellectual deficiency (ID). Several genes are involved in such complex CCA. On the other~     hand, several studies pointed to the favorable cognitive outcome of individuals/fetuses with~     an apparently isolated CCA (ICCA) during pregnancy in about 70% of cases. However, there are~     still 30% of cases with ID or developmental delay. The precise incidence and severity of~     these disorders are presently unclear. Therefore, prenatal counseling of couples facing a~     prenatal diagnosis of ICCA is still elusive.~      Our aims are to unravel the genetic causes of CCA by combining phenotypic and genetic~     analyses in a prospective cohort of patients with CCA and intellectual disability, in order~     to improve prenatal information.~   "
106927|NCT02167828|"~     Prior research has documented serious health, mental health, and social-behavioral issues~     among people living with HIV (PLH) in St. Petersburg. The investigators have established that~     PLH are clustered in friendship groups with other HIV+ persons and that an intervention~     delivered to groups composed of HIV+ men who have sex with men (MSM) who were friends in real~     life reduced mental health distress more than individual counseling. Specific aims of the~     collaborative mixed-methods, qualitative/ quantitative research are to: (1) identify~     facilitators and barriers of medical care attendance and ART adherence among PLH in St.~     Petersburg; (2) integrate these data into an intervention designed to increase HIV care~     attendance, retention, and adherence; (3) carry out a test-of-concept pilot study that~     recruits groups of PLH friends and delivers an intervention to intact PLH friendship groups~     to encourage mutual social support for attending medical appointments and adhering to HIV~     care; and (4) evaluate the effects of the intervention on both behavioral and biological~     measures, including viral load. These specific aims will be achieved by research carried out~     in two phases:~      In Phase I, we will conduct in-depth interviews with 60 PLH and key informants in St.~     Petersburg purposively selected to include HIV+ persons in and not in medical care, adherent~     or not adherent to ART, and including men and women representing diverse exposure risks.~     In-depth interviews will be analyzed to identify factors associated with attending or not~     attending care and adhering or not adhering to ART, as well as identifying how HIV+ friends~     can support one another in HIV care entry, retention, and adherence.~      In Phase II, the investigators will undertake a randomized intervention pilot study in which~     20 groups of PLH friends are recruited by enrolling a PLH seed who is not reliably in care or~     is ART nonadherent and then recruiting all friends known by the seed to also be HIV+. A~     7-session group intervention will be undertaken with all members of the friendship groups in~     the experimental condition to increase care and adherence-related social support,~     problem-solving, and mutual assistance for care. Baseline to 6-month followup data will~     determine whether the intervention produces greater improvement than found in the comparison~     group in care attendance and treatment adherence, improved mental health, lower substance~     use, and lower HIV viral load.~   "
106928|NCT02167815|"~     This investigation is a Post Marketing Follow-Up Study for Mepilex XT conducted as part of~     Mölnlycke Health Care's quality system. The primary objective is to evaluate the performance~     of the dressing when used as intended on exuding Venous Leg Ulcers (VLUs) in the inflammatory~     and granulating stages of the wound healing process.~   "
106929|NCT02167802|"~     Community bacterial infection remains to this day a common cause of morbidity and mortality~     in children, which preventability is a challenge for clinicians. In a previous work, the~     investigators found that 76% supported children admitted to the ICU for severe bacterial~     infection were appraised as suboptimal and significantly associated with an increased risk of~     death. In this context, the investigators seek to identify indicators of extractable data~     PMSI and SNIIR -AM associated with a higher risk of suboptimal early taking care of children~     with severe bacterial infection in order to combine them and use them as a score or decision~     tree that the investigators will validate data from a national prospective multicenter study~     including 512 children admitted to the ICU for severe infection. The investigators then~     propose a score associated with a risk of suboptimality care to evaluate the performance of~     the healthcare system .~   "
106930|NCT02167789|"~     This clinical investigation is a prospective, non-randomized, multi-center, pivotal~     trial.This trial is being performed in order to demonstrate the sensivity of the diagnostic~     feature Physiological Diagnostic (PhD).~   "
106931|NCT02167776|"~     Male circumcision has been demonstrated by three randomized trials to be a highly effective~     method of HIV prevention, leading the World Health Organization to recommend its widespread~     implementation. The investigators' prior work in Tanzania has shown that the acceptability~     and uptake of male circumcision depends highly on religious beliefs. The investigators~     hypothesize that the uptake of male circumcision can be increased in villages in which male~     circumcision is offered in conjunction with church-based teaching and practice, compared with~     villages in which male circumcision is not promoted through churches.~      The investigators will conduct a community randomized trial in rural Tanzania, where the~     government is systematically providing free male circumcision via campaigns in villages in~     which rates of circumcision are low. Prior to the start of the campaign, villages will be~     randomized to receive or not to receive church-based and culturally-informed promotion of~     male circumcision. All villages will receive the standard non-church-based health education~     that accompanies male circumcision campaigns.~      The investigators will compare rates of male circumcision, both by self-report and by~     demographic data collected at the time of circumcision, among men and boys before and after~     the campaign in intervention villages with church involvement versus control villages without~     church involvement.~   "
106932|NCT02167763|"~     The purpose of this study is to evaluate the safety and effectiveness of the VeraCept Low~     Dose Intrauterine Copper Contraceptive compared to the standard T shaped copper IUD, the~     TCu380.~   "
106933|NCT02167750|"~     The primary purpose of the research is to test the short-term effects of the consumption of~     beverages containing phytochemicals and caffeine on several aspects of cognitive performance.~   "
106934|NCT02167737|"~     This study aims to determine if a bedside decision aid used in the ED for mechanical fall~     prevention can increase patient participation in management options that decrease their fall~     risk. Additionally, the investigators aim to determine if there are gender differences in~     patient choices in management options and accomplished goals inspired by the decision tool.~   "
106935|NCT02167724|"~     The aim of this study is to know the bucco-dental status of patients with schizophrenia in~     Côte d'Or.~      Participation in this study will last only as long as it takes to:~        -  carry out a bucco-dental examination: evaluation of dental plaque and calculus~        -  take a blood sample to assess needs in vitamin C (only for patients included at DIJON~          CHU and CHS Chartreuse)~        -  complete a 30-minute questionnaire: clinical data and answers to questions concerning~          dental hygiene and eating habits.~   "
106936|NCT02167711|"~     The current standard treatment of inoperable intrahepatic cholangiocarcinoma (bile duct~     cancer in the liver) is chemotherapy, which is of limited efficacy. The use of selective~     internal radiotherapy treatment (SIRT-Y90) is proven efficacious in patients with~     intra-heptic tumor. Previous experience with SIRT is safe in patients with intrahepatic~     cholangiocarcinoma. This study aims to study the benefits of sequential administration of~     SIRT followed by standard chemotherapy for treatment of inoperable intrahepatic~     cholangiocarcinoma.~   "
106948|NCT02167555|"~     Primary objective is to characterize the relative bioavailability and kinetic profile of wild~     blueberry polyphenols over 24-hours period.~      Secondary objective is to examine the relationship between bioavailability and kinetic~     profile of wild blueberry polyphenols on markers of chronic diseases.~   "
107245|NCT02163642|"~     The purpose of this study is to demonstrate that 1) the secretion of mucins, antimicrobial~     peptides and Toll-like receptors is altered in certain patients with non-CF bronchiectasis,~     which makes them more susceptible to be infected by potentially pathogenic bacteria (PPB);~     and 2) the electronic nose is able to detect patterns of specific Volatile Organic Compounds~     (VOC) for patients with non-CF bronchiectasis colonized by PPB.~   "
106937|NCT02167698|"~     This study attempts to study a new ventilation mode in children with Acute respiratory~     distress syndrome (ARDS). Despite decades of research, no intervention has brought about a~     significant decrease in ARDS mortality. Moreover, most of the studies are adult-based and~     have been extrapolated to children. Airway pressure release ventilation (APRV) mode is~     hypothesized to be superior in terms of lower need for sedation, shorter duration of~     mechanical ventilation, etc. It is unique and the first worldwide randomized controlled trial~     on APRV mode in children.~      We plan to recruit a minimum of 50 children aged (1 month-12 years) in each group. The study~     is to be conducted at the Post-Graduate Institute of Medical Education and Research (PGIMER),~     Chandigarh between March 2014 to March 2016. This trial would recruit children with~     respiratory failure and early ARDS and, randomize them to receive either conventional~     ventilation or the APRV mode. Rest of the supportive care has also been protocolized so that~     both groups receive treatment as per the existing best practices in every aspect. The primary~     outcome being studied is the number of ventilator-free days. The secondary outcomes include~     length of PICU stay, hospital stay, organ-failure free days, 28 day & 3 month survival,~     biomarkers of lung injury (IL-6, IL-8, Angiopoeitin-2, soluble-ICAM-1, etc), functional~     status, Pulmonary function tests, etc. Funding request would be sent to the Indian Council of~     Medical Research, New Delhi, India.~      Assessing lung biomarkers like Interleukin-6 would assess the role of different modes of~     ventilation in acting as triggers for multi-organ dysfunction as well as for worsening lung~     injury. This pathbreaking research is likely to open up new avenues upon completion.~   "
106938|NCT02167685|"~     The prospective observational study is to establish a registry database to evaluate the~     potential impact of prior treatment with CMX001 on the long-term incidence of specific~     events, such as outcomes, late CMV and other Double-stranded DNA virus associated events, s~     well as survival rates in subjects previously enrolled in selected clinical studies of~     CMX001. Each Registry participant will be followed for a period of approximately 3 years from~     their enrollment in the Registry.~   "
106939|NCT02167672|"~     Hysterectomy (surgical removal of the uterus) is the most common major gynaecological~     operation in women in developed countries. In Queensland, 6000 women require a hysterectomy~     for irregular periods, benign tumours or pelvic pain every year. Surgical approaches to~     surgical removal of the uterus (womb) include Laparoscopic Hysterectomy (LH), Vaginal~     Hysterectomy (VH) and Abdominal Hysterectomy through an abdominal incision (AH).~      It is widely accepted that LH and VH are less invasive surgical procedures, cause less~     bleeding, surgical complications and pain and are associated with quicker recovery from~     surgery than the more invasive AH. In a clinical trial comparing LH and AH we recently~     demonstrated that LH outperforms AH with regards to cost effectiveness causing less total~     health-services cost than AH.~      Implementation of LH in Queensland could save $9.8 million every year. Despite the evidence~     for LH and VH, 2600 hysterectomies (43%) are still performed through an open, abdominal~     incision. In brief, a common but outdated operation is still performed regularly causing not~     only unnecessary pain, surgical adverse events and longer hospital stay but also increased~     healthcare costs.~      This study will assess reasons why a significant number of gynaecologists and patients prefer~     AH over LH (Barriers to the uptake of laparoscopic hysterectomy). We will survey specialist~     gynaecologists as well as patients who have had a hysterectomy for different health reasons.~     Based on the information from the survey the investigators will develop an intervention to~     increase the rate of laparoscopic hysterectomies in Queensland and pilot test it.~   "
106940|NCT02167659|"~     Based upon the current state of science, the investigators are proposing to conduct a~     randomized clinical trial in which participants are randomized post-surgery to either BIS or~     circumferential (tape) measurements for follow-up arm measurements. When patients in the BIS~     group have an L-Dex change that is ≥6.5 units higher than the pre-surgical baseline measure,~     and when patients in the tape measurement group have a volume change in the at-risk arm that~     is between ≥ 5% and <10% above pre-surgical baselines (without similar change in non-at-risk~     arm), both will receive four weeks of 23-32 mm compression sleeve and gauntlet therapy.~   "
106941|NCT02167646|"~     Sensory coverage in the finger continues to be a challenging problem. This study reports~     sensory reconstruction of the fingers with the bilaterally innervated dorsal digital flaps~     and compares the results between the dual- and single-innervated flaps.The main evaluated~     outcomes are static 2-point discrimination and Semmes-Weinstein monofilament scores of the~     flap, fingertip pain and joint motion.~   "
106942|NCT02167633|"~     To determine whether stereotactic radiosurgery of metastatic spinal cord compression is~     equivalent to decompressive surgery followed by external body radiation therapy to maintain~     ability to walk at 6 weeks.~   "
106943|NCT02167620|"~     Schizophrenia is associated with a lifespan shortened by 20 years, due to cardiovascular~     disease (CVD), with antipsychotic (AP) medications understood to contribute to this risk~     through associated metabolic side-effects. Metformin, a medication used to treat prediabetes,~     and diabetes in the general population, holds promise with regard to reduction of AP-related~     metabolic problems, but has not been directly tested in early episode patients beyond weight~     loss, nor specifically in patients with diabetes or prediabetes and psychosis. We propose to~     replicate findings that metformin can reduce weight gain, and dysglycemia uniquely focusing~     on an early episode population diagnosed with prediabetes or diabetes. To help determine~     long-term risk/benefit of adjunctive metformin, we propose to look at changes in abdominal~     and liver fat, two well-established risk factors for CVD. Given links between dysglycemia,~     obesity with hippocampal volume loss and cognitive dysfunction, we will explore if~     improvements in metabolic indices are associated in changes in cognition and brain structure.~   "
106944|NCT02167607|"~     Primary objective is to determine the bioavailability of and characterize the kinetic profile~     of target polyphenol metabolites of potatoes over 6 hour postprandial period.~      Secondary objective is to assess the influence of potatoes' bioavailability and kinetic~     profiles on markers of chronic diseases.~   "
106945|NCT02167594|"~     This study will evaluate 18F-AV-1451 for brain imaging of tau in subjects with progressive~     supranuclear palsy (PSP), corticobasal degeneration (CBD) and healthy volunteers.~   "
106946|NCT02167581|"~     Systematically compare the phenotype and genotype of epithelial odontogenic tumors in~     children and adults with a clinical, radiographic, pathologic and molecular level.~      Either:~      establish an observatory of this multidisciplinary tumor establish a tumor bank annotated~     scale unparalleled testing pathophysiological hypotheses search for prognostic factors.~   "
106949|NCT02167542|"~     It has been demonstrated the application of noninvasive positive pressure ventilation (NPPV)~     to assist spontaneous breathing through a face mask during fiberoptic bronchoscopy (FOB) with~     bronchoalveolar lavage (BAL) in severely hypoxemic, nonintubated patients. With NPPV, FOB was~     well-tolerated, significantly improved the PaO2/FiO2 ratio, and successfully avoided the need~     for endotracheal intubation. Two randomized studies have provided supporting evidence that~     the application of NPPV or CPAP via a face mask was superior to oxygen supplementation alone~     during FOB.~      For this reason patients who require FOB and are hypoxemic and/or mild hypercapnic (TcCO2 <~     60mmHg) will be compared in a randomized study by comparing NPPV vs CPAP Boussignac (Vygon)~     delivered through a face mask.~   "
106950|NCT02167529|"~     The purpose of this study is to evaluate the evolution of quality of life and voice function~     with different questionnaires (VIH, SF36) before and after total thyroidectomy.~   "
106951|NCT02167516|"~     Complementary and alternative medicine has been employed over thousands of years to relieve~     knee Osteoarthritis (OA) pain. Xinfeng Capsule, a patent Chinese herbal medicine, has been~     used in the treatment of Knee Osteoarthritis (KOA) Some studies involving animal subjects may~     explored its mechanism. However, presently, there is a lack of large-sample, multicenter,~     randomized, controlled trials to evaluate the effects of Xinfeng Capsule treated for KOA.~     Therefore, the investigators designed a randomized, placebo-controlled, double-blind,~     multicenter trial to evaluate the effectiveness and safety of Xinfeng Capsule in the~     treatment of KOA.~   "
106952|NCT02167503|"~     The study was conducted to evaluate the effect of anti-viral treatment on long-term outcome~     on patients with chronic hepatitis B.~   "
106953|NCT02167490|"~     The hypothesis of this trial are that:~        -  avoiding axillary surgery does not worsen the outcome of patients with small breast~          cancer the absence of the pathological information on the risk of recurrence given by~          nodal status is not worsening outcome of these patients~        -  pre-operative imaging of the axilla can identify patients with clinically relevant nodal~          burden.~      The aims of this prospective randomized study are:~        -  to verify whether, in presence of a negative preoperative axillary assessment, SLN can~          be spared~        -  to verify whether, in presence of a negative preoperative axillary assessment, the~          decision on adjuvant medical treatment can be taken according only to the biology of the~          tumour without the prognostic information achieved by SLNB on the nodal status~        -  to verify whether, in presence of a negative preoperative axillary assessment, the~          patients' quality of life can be improved by a less invasive surgical procedure.~   "
106954|NCT02167477|"~     An anaesthetist inserts a laryngoscope into the mouth to see the voice-box (larynx) for~     tracheal intubation, when a tube is advanced into the windpipe (trachea) to protect the~     airway and administer anaesthetic gases.~      This study aims to compare traditional (direct view) Macintosh (MAC) laryngoscopy with Storz~     C-MAC videolaryngoscopes in subjects presenting for obesity reduction surgery using a novel~     photographic overlay technique to analyse the basis for any differences.~   "
106955|NCT02167464|"~     Comparative Effectiveness Research using an intent-to-treat approach in 8 clinics in South~     Carolina. The investigators will assess 4 efficacious approaches to controlling~     treatment-resistant hypertension (TRH): Aldosterone Antagonist, Referral to Hypertension~     Specialist, Renin Treatment-Guided Therapeutics, and combination of Hypertension Specialist~     and Renin Treatment-Guided Therapeutics. Patients with TRH are evaluated with the BpTRU~     device for an accurate and representative blood pressure measure on two occasions before~     entry into the study. Qualitative data from focus group discussions with practice staff, and~     patient surveys and interviews will provide contextual data to help explain why some~     interventions are more acceptable and successful than others.~   "
106956|NCT02167451|"~     The purpose is to determine if the addition of Maraviroc to a standard transplant regimen~     will reduce the incidence of graft versus host disease in children and young adults after a~     stem cell transplant.~   "
106957|NCT02167438|"~     This study is being conducted to evaluate an FDA approved device called the HEM-AVERT®~     Perianal Stabilizer and the efficacy in reducing the C-section rate and/or reducing the~     second stage of labor times.~   "
106958|NCT02167425|"~     To improve ART initiation among people who inject drugs, the investigators propose to develop~     and pilot a multi-component Integrated Methadone and Antiretroviral Therapy strategy (IMAT)~     in Dar es Salaam, Tanzania. In doing so, the investigators anticipate building a functional~     model of methadone and ART integration that improves the effectiveness and efficiency of~     service delivery.~   "
106959|NCT02167412|"~     Orthostatic intolerance refers to symptoms that occur with standing and improve or resolve~     with recumbency. Few studies have evaluated orthostatic intolerance symptoms by~     electroencephalography (EEG), and none of those studies have focused on the adolescent-aged~     patient. This study will compare EEG characteristics and sweat rate during head-upright tilt~     (HUT) testing among patients with postural tachycardia syndrome (POTS) and patients with~     syncope without POTS. Patients with POTS will also undergo a separate HUT with abdominal and~     lower extremity compression. The primary aim of this study is to characterize video EEG~     changes that correspond with orthostatic intolerance in youth during HUT testing. The~     investigators hypothesize that the clinical encephalopathy related to POTS and referred to as~     'brain fog' will have an electrographic correlate. Secondary aims include (1) EEG comparisons~     of POTS symptoms with and without abdominal and lower extremity compression during HUT, (2)~     correlation between sweat rate and EEG changes during HUT, and (3) analysis of EEG~     characteristics that distinguish syncope with POTS from syncope without POTS. The~     investigators hypothesize that POTS patients have prolonged syncopal prodromes (compared to~     syncope patients without POTS) which are protective of syncope during daily activities.~   "
106969|NCT02167269|"~     The investigators invented the baby enclosed afferent reservoir anesthesia circuit (Baby EAR)~     which could be used safely in children between 5 and 20 kg, using a fresh gas flow of 2.5 and~     3 L/min in the spontaneous breathing and controlled breathing, respectively. There has as yet~     been no study comparing the minimal fresh gas flow between the Baby EAR and Jackson-Rees~     anesthesia circuit (JR).~   "
107335|NCT02162459|"~     This study investigates the strength gains associated with resistance training in a group of~     18 male high school athletes consuming either a whey protein supplement or chocolate milk~     following their exercise.~   "
137686|NCT01765049|"~     Breast density change after short term use of aromatase inhibitor in postmenopausal ER~     positive breast cancer would predict endocrine responsiveness~   "
106960|NCT02167399|"~     Evidence supports the use of two dimensional video analysis to assess the presence of dynamic~     knee valgus during generally used screening tasks, however there is limited evidence to~     support the use of the various smart phone applications as a time and money saving option for~     clinic use . Subjects that present to the clinic and display dynamic valgus at the knee~     during the lateral step down test will be given the option to participate in the study. If~     they consent to the study they will be evaluated with 2-Dimensional video analysis to~     determine the amount of valgus present at the knee during the lateral step down test. The~     subject will also have the smart phone attached to their lower leg and the amount of valgus~     will be concurrently measured by the selected application. The primary objective of this~     study is to determine the validity of an application on the smart phone to provide an~     objective measure of dynamic knee valgus. The secondary objective of this study is to~     determine the possibility of the use of the application as a source of feedback during~     neuromuscular re-education training in order to decrease or eliminate a subject's dynamic~     valgus collapse and subsequently decreased their risk for future injury.~   "
106961|NCT02167386|"~     Black men who have sex with men (MSM) have among the highest rates of new HIV infections of~     any group in the United States. Developing effective HIV prevention interventions that work~     with this group is a critical element of the National HIV/AIDS Strategy. In the first phase~     of our study (the ethnographic phase), the investigators will carry out community-based~     research that will explore structural, social and cultural factors relevant to how Black MSM~     might engage with Pre-Exposure Prophylaxis (PrEP). This phase of community-based research~     will inform the design of an enhanced PrEP adherence intervention, which will be subsequently~     tested at a community-based health clinic in Harlem in the second phase of the project.~   "
106962|NCT02167373|"~     The purpose of this study is to determine whether the use of a mobile sensing platform in a~     primary care setting has an effect on provider workflows, patient outcomes, patient~     engagement, patient self-help behavior, health research, and total cost of care.~   "
106963|NCT02167360|"~     This is a single arm, open-label, multi-center, phase II study to determine the efficacy and~     safety of CTL019 in adult patients with r/r B-cell ALL. The study will have the following~     sequential phases: Screening, Pre-Treatment, Treatment and Primary Follow-up, Secondary~     Follow-up (Relapse Follow-up) and Survival Follow-up. The total duration of the primary~     follow-up is 1 year from cell infusion. Safety will be assessed until the end of the~     treatment and primary follow-up phase.~   "
106964|NCT02167347|"~     Aim:~      To assess the feasibility of culturally adapted Family Intervention for Psychosis.~      Design:~      Randomized Control Trial~      Setting:~      psychiatric department of different hospitals~      Participants:~      A total of 36 caregivers of Psychosis patients will be randomized to psychological~     Intervention and treatment as usual arm.~      Intervention:~      Culturally Adapted Family Intervention for Psychosis~      Outcome measure:~      Positive and Negative syndrome scale (PANSS) Experience of care -giving inventory(ECI) Care~     Well-Being & Support(CWS)~   "
106965|NCT02167334|"~     the aim of the study is to determine if Spontaneous Ventilation with Positive Pressure~     Ventilation (PPV) preoxygenation allows a longer non hypoxemic apnea time during panendoscopy~     compared to spontaneous breathing preoxygenation.~      the hypothesis is PPV extends the residual functional capacity of lung so it provides more~     oxygen during apnea.~   "
106966|NCT02167321|"~     The introduction of total mesorectal excision (TME) and the progress of neoadjuvant~     chemoradiotherapy has significantly reduced the risk of local recurrence in locally advanced~     rectal cancer. However, systemic recurrence rate is not being improved and that is considered~     as the cause of unsatisfactory overall survival of patients with rectal cancer. Relatively~     higher systemic relapse rate than local recurrence rate is probably due to the insufficient~     control of systemic micrometastasis during adjuvant chemotherapy. The efficacy of adjuvant~     combination cytotoxic chemotherapy after surgery in treatment of rectal cancer remains~     controversial. In addition, preoperative radiotherapy increases surgical complication such as~     anastomosis site leakage and radiotherapy itself worsen sexual and urinary function and bowel~     habit which result in aggravation of the quality of life. Furthermore the preoperative~     chemoradiotherapy upto 3 months not only extends treatment period but increases cost of care.~     To reduce the possibility of overtreatment, it is needed to confirm that the preoperative~     chemoradiotherapy is absolutely necessary to locally advanced rectal cancer patients with~     safe circumferential margin (CRM) resected curatively by standardized TME operation.~      In this study, investigators aim to evaluate the efficacy of adjuvant FOLFOX chemotherapy~     after TME without preoperative chemoradiotherapy in patients with locally advanced rectal~     cancer having spared CRM are not inferior to that of current standard treatment.~   "
106967|NCT02167308|"~     Background: Obesity-related diseases have a profound economic impact on health care systems.~     Laser acupuncture has been shown to have beneficial effects on obesity. However, to our~     knowledge, those trials were either non-randomized, non-blinded, or included low-calorie diet~     control. Investigators have therefore designed a patient-assessor-blinded, randomized,~     sham-controlled crossover trial to investigate the significance of laser acupuncture on~     obesity.~      Methods/design: One hundred and four subjects above 20 years of age with a body mass index~     (BMI) of over 25 kg/m2 will be divided into two groups: experimental and control. Each~     subject will receive the treatment relevant to their group three times a week for eight~     weeks. After eight weeks of treatment the subject will enter a two week washout period, after~     which the subjects will switch groups. Measurements will include BMI, body fat percentage,~     waist-to-hip ratio (WHR), waist circumference, hip circumference, skinfold thickness, thigh~     circumference, body fat, blood pressure, heart rate, hunger, and the 36-item short-form~     health survey (SF-36).~      Discussion: The results of this pilot study will provide the basis for future large-scale~     multicenter trials investigating the effects of laser acupuncture on obesity.~   "
106968|NCT02167295|"~     Cancer of the oral cavity is one of the fastest growing cancers among men in Taiwan. Previous~     research has established a strong link between betel quid chewing, a common practice among~     Taiwanese men, and oral cancer. However, despite the strong association, no attempt has been~     made to develop behavioral measures to facilitate betel quid cessation. This application~     extends upon existing collaboration between MD Anderson and China Medical University Hospital~     (CMUH) and seeks to characterize betel quid chewers and their withdrawal symptoms, in order~     to address an urgent cancer epidemiology issue in Taiwan.~   "
106970|NCT02167256|"~     AZD0530 is an inhibitor of Src and Abl family kinases1. It has been developed as treatment~     for malignancies because these kinases play a role in tumor invasion and proliferation.~     However, the Src family kinases (SFKs) are highly expressed in brain and have major effects~     on synaptic plasticity2. Moreover, the investigators have recently shown that a specific SFK,~     namely Fyn, is aberrantly activated by specific conformations of the Amyloid Beta (Aß)~     peptide from Alzheimer's disease (AD). Genetic deletion of Fyn rescues AD deficits in~     preclinical models. This clinical trial will test the potential benefit of AZD0530 for~     Alzheimer's disease modification.~   "
106971|NCT02167243|"~     The purpose of this project is to evaluate the efficacy of a behavioral economic intervention~     to improve self monitoring of blood glucose (SMBG) in adolescents and young adults with T1D.~     The intervention will reinforce patients for conducting SMBG, with escalating reinforcers~     provided when patients achieved sustained periods of testing at least 4 times/day at~     appropriate intervals. A 6-month trial will be conducted in which 60 patients will be~     randomized to: (1) standard care or (2) standard care plus the reinforcement intervention.~   "
106972|NCT02167230|"~     This study aims to test the hypothesis that jailed-balloon technique(JBT) is superior to~     jailed-wire technique(JWT) in non-left main coronary bifurcation percutaneous coronary~     intervention(PCI) by lowering the risk of side branch(SB) loss and PCI related myocardial~     infarction, as well as 1-year major adverse cardiovascular events(MACEs).~   "
106973|NCT02167217|"~     While it has been known for many years that corticosteroid use benefits boys with Duchenne~     Muscular dystrophy (DMD), most clinicians do not consider treating until after age 3 or 4~     years of age. The primary reason for the delay is that daily corticosteroid use has many side~     effects including short stature, obesity, and osteoporosis. A recent randomized blinded study~     of weekend oral corticosteroid use over one year showed equal improvement in strength with~     fewer side effects, particularly as related to growth and cushingoid changes. The~     investigators will test the efficacy of oral weekend corticosteroid use in infants and young~     boys with DMD who are under age 30 months. The investigators have demonstrated that the~     Bayley-III Scales of Infant development shows that infants and young boys in this age group~     who are untreated decline in abilities when compared to their peers. Here, in this Phase 2~     historically controlled trial, the investigators will use these two measures and treat boys~     at five Muscular Dystrophy Association-DMD centers~   "
106974|NCT02167204|"~     This pilot clinical trial studies fluorine F 18 fluorothymidine (FLT) positron emission~     tomography (PET)/computed tomography (CT) in measuring cell proliferation in patients with~     brain tumors. Comparing results of diagnostic procedures done before, during, and after~     treatment may help doctors measure tumor growth and plan the best treatment.~   "
106975|NCT02167191|"~     It is widely known that exercise improves general fitness and that fitter patients recover~     more easily from illness and surgery. Conversely, unfit patients have a significantly higher~     morbidity and mortality after surgery and a longer inpatient stay. This will become~     increasingly important in an aging population as baseline fitness generally declines with~     age.~      One method of improving cardiovascular fitness is by using low intensity endurance training~     programmes, a disadvantage of these it that they can take several months to show improvement.~     High intensity interval training (HIT) programmes that use short episodes of high intensity~     exercise have also been shown to improve fitness. These HIT programmes have also shown~     improvement in functional capacity and quality of life in patients with chronic disease. An~     advantage of HIT is that improvements in fitness may occur in a shorter time than traditional~     endurance training. It is also known that HIT can give superior gains over endurance~     training.~      The primary aim of this study is to determine whether an improvement in aerobic fitness, as~     judged by a 2ml/kg/min increase in VO2peak, can be achieved within 31 days via a HIT~     programme, in a group of healthy elderly volunteers.~      As a secondary aim we will assess whether this programme would be acceptable to the group~     studied, through determination of subject compliance and adherence to the training programme.~   "
106976|NCT02167178|"~     Although major surgery is often required to treat abdominal problems, there is a significant~     risk of death or complication following these operations. By using ultrasound the amount and~     timing of fluid patients receive during operations can be optimised and the risk of surgery~     reduced. However, little is known about the exact changes in blood flow in the small vessels~     of the body in response to fluid. A greater understanding of this may allow for more~     appropriate care of patients undergoing this type of surgery in the future.~      In this study of healthy volunteers we will attempt to better understand how fluid~     administration guided by ultrasound effects blood flow in large and small vessels, by using~     two different techniques of ultrasound imaging. A narrow bore (approximately 4-5mm diameter)~     ultrasound probe will be passed through the nostril and mouth to rest within the oesophagus~     allowing measurement of blood flow in the main artery, while a second probe will be rested on~     the volunteer's abdomen and used to record changes in blood flow in small liver blood~     vessels. Comparison of these two techniques during the administration of fluid will allow us~     to better understand the relationship between large and small vessel blood flow.~      Because different types of fluid may behave in different ways, we will test the effect of two~     types of fluid commonly used in clinical practice; `normal` saline solution and gelofusine.~   "
106977|NCT02167165|"~     This study tested the hypothesis that response to digoxin is modulated by single Nucleotid~     Polymorphism (SNP):~        -  Multi Drug Resistance (MDR1) gene haplotypes and Solute carrier organic anion~          transporter family member 1B3 (SLCO1B3) gene Polymorphism and their role in the response~          to treatement.~        -  Aldosterone synthase (CYP11B2) gene and sodium channel, voltage-gated, type V alpha~          subunit gene (SCN5A) correlated with atrial fibrillation and their roles in response to~          digoxin.~   "
106978|NCT02167152|"~     The purpose of this study is to learn about the impact of ischemic preconditioning in~     reducing contrast induced kidney damage in people with pre-existing kidney problems who are~     undergoing cardiac catheterization procedures.~   "
106979|NCT02167139|"~     This is a randomised, double-blind, parallel group, multicentre clinical study to evaluate~     the efficacy, safety, tolerability, pharmacokinetics and immunogenicity of SB5 compared to~     Humira® in subjects with moderate to severe RA despite MTX therapy.~   "
107336|NCT02162446|"~     The purpose of this study is to assess the safety and tolerability of 68Ga-OPS202 used for~     the diagnosis of gastroenteropancreatic neuroendocrine tumors (GEP NETs).~   "
106980|NCT02167126|"~     Kinesio Taping (KT) is used often, but there is little scientific information on its effect.~     The aim of this study was to evaluate the effects of KT on knee extension force among soccer~     players. KT (K-Tape®) and Micropore (3M®) were applied on the right and left thighs of 34~     professional soccer players (20 males and 14 females). Half of the participants had KT~     applied to the left and half to the right thigh. The subjects performed two maximal isometric~     voluntary contractions of the quadriceps pre, immediately post, and 24 hours after tape~     application. Isometric knee extension force was measured using a load cell and the following~     variables were assessed: peak force, time to peak force, rate of force development until peak~     force, time to peak rate of force development and 200 ms pulse. There were no statistically~     significant differences between KT and Micropore conditions or among testing sections (pre,~     post, and 24h after). Therefore, taping (independently of the type of tape used or time since~     application) did not affect the force-related measures assessed during maximal isometric~     voluntary knee extension trials performed by healthy professional athletes.~   "
106981|NCT02167113|"~     This non-interventional clinical study will be conducted to prospectively collect serial~     plasma samples from subjects with chronic HBV infection who are initiating antiviral therapy.~     These samples will be used to estimate clinical utility endpoints for the Aptima HBV Quant~     assay, which is used as an aid in the management of HBV-infected patients undergoing HBV~     antiviral therapy.~   "
106982|NCT02167100|"~     The purpose of this study is to determine linkage and retention in care in patients with HIV~     infection and reasons for loss to follow up Care in a High HIV-caseload Inner City Primary~     Care Practice in Sydney, Australia.~      The investigators hypothesise that patients attending HHMP will have higher rates of linkage~     and retention in care than the US HIV-infected population, and equivalent to Australian~     modelling.~   "
106983|NCT02167087|"~     This study is a clinical feasibility trial that will contribute to the clarification of~     whether sentinel node mapping with indocyanine green (ICG) provides a better basis for~     staging of colorectal cancer.~   "
106984|NCT02167074|"~     The aim of this study is to compare the diagnostic accuracy of two EUS-guided tissue~     acquisition devices; the 25G Echotip Ultra Fine Needle Aspiration (FNA) device and the 20G~     Echotip ProCore Fine Needle Biopsy (FNB) device.~   "
106985|NCT02167061|"~     This Phase I clinical study is to evaluate the safety/tolerability and pharmacokinetics of~     DA-1229_01 and to investigate the effect of food on the pharmacokinetics of DA-1229_01 in~     healthy male volunteers~   "
106986|NCT02167048|"~     This double-blind crossover study aims to compare cognitive performance (e.g., working~     memory, selective attention and cognitive flexibility) of children ages 6-18 years diagnosed~     with ADHD of the combined type (ADHD-C) or inattentive-type (ADHD-IA) and currently on > 20~     mg/day of psychostimulants (psychostimulants) on: a) their current dose of psychostimulants,~     vs. b) a lower-dose of psychostimulants (half of their current dose).~      The investigators hypothesize that the lower-dose psychostimulants will result in better~     cognitive performance than moderate-to-high doses of psychostimulants.~   "
106987|NCT02167035|"~     To compare Combigan BID vs Simbrinza TID in subjects currently being treated with Latanoprost~     for Open-Angle Glaucoma or Ocular Hypertension. Both of these drugs are currently FDA~     approved as combination therapy for patients with Open-Angle Glaucoma or Ocular Hypertension.~     The purpose of this clinical trial would be to assess which treatment, if either, is superior~     in lowering intraocular pressure (IOP). A secondary objective is to assess the tolerability~     of each drug.~   "
106988|NCT02167022|"~     Cerebral palsy (CP) is a non-progressive disorder caused by an insult or injury to the brain~     when the brain is most rapidly developing and which results in some motor dysfunction. Causes~     for the injury to the brain are numerous and can occur prior to birth, during the birth~     process, or within the first few months following birth. The motor dysfunction can involve~     any or all four extremities but most often affects the legs, causing abnormal ambulation. The~     level of severity depends on the extent of the injury to the brain and can be mild to severe.~     In severe instances, the child is dependent on others for all his/her care.~      There is no known cure for CP, but physical and occupational therapies are administered in an~     attempt to improve function. The frequency of these therapies varies from once a week (the~     standard of care in the Western Hemisphere) to five times a week (the standard of care in~     Asia and some Eastern European countries). The current understanding of brain plasticity~     offers a theoretical explanation to justify the more intense approach. Active repetitive~     motor skill-directed rehabilitation utilizes the plasticity of the brain and can restore some~     function. Intense active physiotherapy can stimulate non-injured but 'dormant' neurons and~     prevent their 'natural' degeneration in order for them to substitute for the function of~     injured neurons. It is the very young brain that is most likely to respond to this therapy.~      The aim of this proposal is to evaluate the effect of administering both physical and~     occupational therapy five times each week for 12 weeks and compare it with the standard of~     care (SOC) approach of one time each week in children between the ages of 12 months and 36~     months. This is the first randomized crossover trial to both enroll this young a population~     of children with cerebral palsy as well as to evaluate this approach from both the therapists~     and the parents perspectives. The number of children that this study will enroll is larger~     than in most CP studies. The children will be evaluated clinically with two validated~     instruments, one of which was designed specifically for children with CP and is administered~     and scored by certified therapists and the other which was designed for children with~     developmental disabilities and is scored by the child's care provider. A sub-set of children~     will have a special type of MRI to evaluate any changes in the neurological structure of the~     brain.~      The Department of Pediatrics at the University of Arizona recently completed a collaborative~     study with the Neurologic Department at the Beijing Children's Hospital where the intense~     approach of five therapies per week is the SOC. The positive results prompted another~     investigation to determine if such an approach would be feasible in the United States. A~     compliance rate of 81% confirmed feasibility and the perception that parents who have a child~     diagnosed with CP will do whatever they can to improve their child's motor function.~   "
106989|NCT02167009|"~     Study to evaluate Prostate Artery Embolization for the treatment of lower urinary track~     symptoms due to Benign Prostatic Hyperplasia and Prostate Size Greater Than 90 Grams.~   "
106990|NCT02166996|"~     A single-center, prospective, randomized comparison with blinded assessment of cosmetic~     outcome.~      To compare cosmetic outcome of surgical defects of head and neck, repaired with~     non-resorbable monofilament sutures from the aspect of suture removal time 7 and 14 days.~     Data are gathered through a standardized form at the time of surgery concerning width and~     length of the surgical excisions, and if the patient has any systemic cortisone treatment or~     diabetes mellitus. At the time of surgery the patients are randomised to a suture time at 7~     or 14 days postoperatively and all receive the same written information about postoperative~     care and restrictions.~      Photographs of the scars are taken one month and one year after the procedure and rated using~     a visual analogue scale (VAS) by three independent assessors blinded to the intervention and~     suture time. The width of the scar is measured after one ear.~      Study hypothesis is that leaving non-resorbable monofilament sutures in clean surgical wounds~     in the head and neck area for up to 14 days does not lead to poor cosmetic outcome.~   "
107337|NCT02162433|"~     The investigators aim to investigate the effect of dexmedetomidine on the perioperative~     respiratory complications in this patient population undergoing both awake and deep tracheal~     extubation.~   "
106992|NCT02166970|"~     In Bismuth II-IV hilar cholangiocarcinoma patients with a predicted survival of longer than 3~     months, metallic stent performance is superior to plastic stenting for palliation with~     respect to outcomes and cost-effectiveness. However, the optimal stent type and the extent of~     drainage are issues that remain to be definitively decided. The optimal endoscopic management~     strategy is contentious. The investigators conduct the present study to prospectively in~     multi-centers compare unilateral (single) with bilateral (multiple) deployment in inoperable~     malignant biliary obstructions to clarify the clinical outcomes of these two deployment~     methods using metallic stents.~   "
106993|NCT02166957|"~     Complete esophageal obstructions leads to definitive fasting. The rendez-vous endoscopic~     approach had already been described for complex stenoses but never for disruption with loss~     of tissue and SES. Patients and methods: This is a retrospective observationnal study about~     patients referred for complete esophageal disruption and classified in two groups: 1/ Long~     disruption (> 5cm), after caustic ingestion or due to an esophageal stripping during SEMS~     removal; 2/ Short disruption (< 5cm), consecutive to radiation therapy. All the procedures~     are performed according the anterograde retrograde approach, using CO2 and under X-rays~     guidance. We report the characteristeristics of the procedures, the efficacy, the time before~     discharge and refeeding, the complications, and the follow-up, especially the number of~     dilatation sessions for each group. The hypothesis is that anterograde retrograde endoscopic~     technique is safe and effective for the management of esophageal disruptions in patients for~     which the surgical treatment confers a high risk of morbidity and mortality.~   "
106994|NCT02166944|"~     The aim of this study is to survey the effect of Tamoxifen in motor neuron disease (MND)~     patients, amyotrophic lateral sclerosis (ALS) with regular riluzole usage. TDP-43 is related~     to ALS. Increased the ubiquitinated or phosphorylated TDP-43 can cause animal model of ALS,~     and TDP43 can be degraded either by proteasome or autophagy pathway system. Autophagy pathway~     can be activated by mTOR inhibition, resulting in ameliorating TDP-43 accumulation and rescue~     in motor function in animal model. Tamoxifen had shown ability of enhance both proteasome and~     autophagy pathway, therefore the investigators assume that Tamoxifen probably can ameliorate~     TDP-43 accumulation and inclusion body formation in ALS.~   "
106995|NCT02166931|"~     The purpose of this study is to determine whether BRAND'S® Essence of Chicken are effective~     in the promotion of resilience and resistance to stress-associated cognitive inhibition.~   "
106996|NCT02166918|"~     In the last decades the impact of several variables on patients' social functioning has been~     investigated with conflicting findings. The involved variables might be grouped in three main~     categories: a) disease-related variables; b) personal resources; c) context-related factors.~     The present study is aimed to identify factors that affect most real-life functioning of~     subjects with schizophrenia and to assess negative and depressive symptoms, neurocognitive~     deficits and impairment of social cognition. Domains of negative symptoms and cognitive~     dysfunctions most associated with impairment of real-life functioning will be identified and~     appropriate data analyses will be carried out to define whether it has a direct or indirect~     impact on real-life functioning. The research units of Turin and Genua will also investigate~     the relationships between insight into the illness and real-life social functioning. The~     research unit of Genua will evaluate prevalence and course of depressive symptoms, insight~     impairment and neurocognitive deficits, and will define the relationships of these aspects~     with suicidal behavior and real-life social functioning. The Naples research unit n.1 will~     investigate the hypothesis that deficits of preattentive and perceptual functions underlie~     impaired social cognition and negative symptoms. An electrophysiological study will be~     carried out in which abnormalities of event-related components and gamma rhythm~     synchronization, relevant to preattentive and perceptual stages of information processing,~     will be studied as endophenotypes of the disorder.~      The study will also investigate the heritability of disease-related variables by evaluating~     them in non-affected, first-degree relatives of subjects with schizophrenia. The research~     unit of Bari will test functionality of genetic variants relevant to dopaminergic signaling,~     that might confer risk for neurocognitive and related prefrontal dysfunction assessed by~     specific functional magnetic resonance imaging (fMRI) paradigms. The Naples research unit n.~     6 will perform an association study between selected putative schizophrenia genes and~     specific psychometric, neurophysiological and neurocognitive schizophrenia endophenotypes;~     moreover, the research unit will search for de novo copy-number variations (CNV) as putative~     risk factors for schizophrenia or schizophrenia endophenotypes and for de novo~     protein-altering mutations that may contribute to the genetic component of schizophrenia~     endophenotypes. The Naples research unit n. 5 will be responsible for defining a standardized~     protocol for the assessment of medical comorbidities in subjects with schizophrenia. All~     psychiatric research units will contribute to assess the role of factors related to the~     context in modulating the impact of variables related to the disease on real-life social~     functioning.~   "
106997|NCT02166905|"~     This partially randomized phase I/IIb trial studies the side effects and best dose of IDO1~     inhibitor INCB024360 in combination with DEC-205/NY-ESO-1 fusion protein CDX-1401 and poly~     ICLC and to see how well they work in treating patients with ovarian, fallopian tube, or~     primary peritoneal cancer who no longer have evidence of disease. Antigens (such as~     cancer/testis antigen [NY-ESO-1] protein) are found on many cancer cells. Vaccines made from~     NY-ESO-1 protein may cause the immune system to produce immune cells and antibodies that may~     help locate the NY-ESO-1 and/or cancer/testis antigen 2 (LAGE-1) antigens on cancer cells. By~     finding them, the immune system may then work to control or eliminate the remaining cancer~     cells. INCB024360 is an inhibitor of an enzyme called indoleamine 2,3 dioxygenase (IDO). This~     enzyme is produced by tumor cells to disable immune cells, and limit the efficacy of immune~     attack. Giving DEC-205/NY-ESO-1 fusion protein CDX-1401 with poly ICLC and IDO1 inhibitor~     INCB024360 may generate stronger and more long lasting anti-cancer immune responses in~     patients with ovarian, fallopian tube, and primary peritoneal cancer in remission.~   "
106998|NCT02166892|"~     Previous studies demonstrated that children served themselves more food when using larger~     plates and bowels. The purpose of this study is to evaluate if self-served portions and~     caloric intake in normal weight and overweight children will be influenced by a specially~     designed eating plates compared to similar size normal plates.~   "
106999|NCT02166879|"~     The primary aim is to determine whether patients with suspected OSAHS as predicted by the~     STOP-BANG questionnaire will have an increased length of stay (LOS) in the postanesthesia~     acute care unit (PACU) compared with those without suspected OSAHS.~      The second aim will be to determine the LOS in patients with known sleep apnea by history.~     This length of stay will be compared with LOS in patient with an affirmative response to the~     STOP-BANG questionnaire to determine if prior knowledge of diagnosed sleep apnea will be~     associated with a lower LOS than in patients with suspected OSA.~      The third aim will be to characterize the adverse clinical outcomes (respiratory,~     cardiovascular, and neurological) associated with suspected OSAHS in patients who respond~     affirmatively to the STOP-BANG questionnaire and in those patients with known OSA. These data~     (including number of desaturations, bradypnea, brady- or tachycardia, and use of reversal~     agents) will be recorded by the PACU nursing staff. Unexpected admissions to the hospital and~     transfers to the intensive care units will also be measured. These data will help identify~     the most critical determinants of length of stay.~   "
108382|NCT02148796|"~     The primary objective of this study is to evaluate if Broncho-Vaxom® given to high risk~     infants for 10 days, monthly, for two consecutive years can increase time to occurrence of~     the first episode of wheezing lower respiratory tract illness (WLRI) during a third~     observation year after therapy~   "
107000|NCT02166866|"~     This study defines cancer caregivers as unpaid individuals who provide physical, practical,~     and/or emotional care and support to the cancer patient in the home setting. They may~     participate in this study if care recipients and the caregiver are both adults (18 years or~     older), with the patient having been diagnosed with cancer.The 8 intervention sessions will~     target the five domains of Quality Of Life (emotional, physical, social, cognitive, and~     spiritual well-being), be provided in group settings, and be delivered in two 45-minute~     sessions each week over a 4-week period.~   "
107001|NCT02166853|"~     Numerous trials support the efficacy and safety of volatile anesthetic agents, namely~     inhalation of sevoflurane through dedicated devices, for the sedation of ICU patients.~     Several preclinical studies have shown that sevoflurane inhalation improves gas exchange and~     decreases pulmonary and systemic inflammation in experimental models of acute respiratory~     distress syndrome (ARDS).~      The purpose of our prospective monocentric, randomized, controlled trial is to evaluate the~     effects of an early 48-hour sevoflurane inhalation on gas exchange and inflammation in~     patients with ARDS.~   "
107002|NCT02166840|"~     Patients with obstructive jaundice due to periampullary tumor can temporarily be relieved of~     their jaundice with transpapillary stenting at endoscopic retrograde~     cholangio-pancreatography (ERCP) prior to operation. Usually plastic stents are used.~      Hypothesis: Self expanding metallic stents offer a be a better alternative for preoperative~     stenting in patients with obstructive jaundice due to periampullary tumour obstruction.~   "
107003|NCT02166827|"~     To evaluate the long-term efficacy of the NeuroAD system~   "
107004|NCT02166814|"~     The purpose of this study is to evaluate the efficacy and safety of combination of~     Fimasartan/Rosuvastatin in comparison to each component administered alone in patients with~     essential hypertension and dyslipidemia.~   "
107005|NCT02166801|"~     Children with cerebral palsy (CP) have life-long motor disorders and are typically subjected~     to extensive treatment throughout childhood. Despite this there is a lack of evidence~     supporting the effectiveness of treatment aiming at improving motor function and activity in~     daily life. The primary area of interest of this research programme is to determine the~     effectiveness of an early intervention program in children younger than 12 months of age who~     are at risk of developing CP. A randomised control trial is planned, addressing hand use,~     mobility and communication in a home-based program. New treatment principles based on recent~     knowledge of brain plasticity will be employed.~      The overarching goal of this research programme is to develop and evaluate new intervention~     principles for children with neurodevelopmental disorders based upon theories of early~     learning induced brain plasticity. Our overall aims can be formulated as follows:~      To evaluate the effects of an early intervention programme on the overall development in~     children with risk of developing cerebral palsy and other neurodevelopmental disorders. The~     program includes intensive intervention towards the foci: hand use, mobility and~     communication in a home based program~      The hypothesis is that the design of the Small-Step-Program intervention, with clear foci on~     specific areas of development during different time periods and conducted in the child's home~     environment, will facilitate development and be more effective than usual care.~      The second hypothesis is that children learn what they practice, meaning that children will~     have a more rapid development within the focus of each specific step in the training, when~     compared to the, for the time being, untrained steps.~      The third hypothesis is that children's ability to learn within the different steps of the~     intervention programme will be influenced by the specific characteristics of any underlying~     brain pathology.~      The fourth hypothesis is that parents in the study group will be less stressed and can better~     cope with their child's situation than parents to children receiving usual care. Thus, the~     tools provided within the Small-Step-Program intervention, like education, supervision and~     feedback of how to practice communication and task performance will make parents more able to~     cope with the child's delayed development.~   "
107006|NCT02166788|"~     BACKGROUND: Spread of metastatic melanoma to the groin lymph nodes (LN) is a common event~     affecting about 350 people a year in Australia. Globally it has been shown that patients with~     involved groin LN, without proven pelvic LN disease on imaging receive 1 of 3 management~     strategies in equal proportions - inguinal lymphadenectomy (IL); ilio-inguinal~     lymphadenectomy (I-IL); or variable use of either depending on circumstances. Different~     experts have strong and polarised opinions favouring either IL or more extensive I-IL with~     existing cases series reporting conflicting data on best cancer outcomes. No high level~     evidence proves which operation is best. HYPOTHESIS: There will be no significant difference~     in DFS between patients having IL or I-IL, conditional on PET/CT scan showing no evidence of~     pelvic disease at the time of diagnosis of groin LN metastatic melanoma. AIMS: To provide a~     rational evidence base for management for melanoma to the groin LNs by randomly assessing the~     effect of each operation on DFS, distant DFS, overall survival (OS), morbidity - including~     early complications and longer-term rates of lymphedema as well as comprehensively assessed~     QOL. Also to clarify the reliability of PET/CT scans for staging pelvic LNs and evaluate any~     health economic benefits of I-IL over IL. TARGET POPULATION: To recruit 634 patients in 5~     years. DESIGN: An Australian led, international, multi-centre, non-inferiority, phase III,~     prospective, randomised clinical trial comparing IL or I-IL for patients with metastatic~     melanoma to groin LNs and no evidence of pelvic disease on PET/CT. ENDPOINTS: DFS, Distant~     DFS, OS and QOL at 5 years. Accuracy of PET/CT for pelvic LN metastases.~      OUTCOMES: International standardization of care, improved cancer outcomes, improved QOL for~     patients with groin metastatic melanoma. Proof of principle about extent of surgery when~     PET/CT is clear in adjacent LN areas, leading to clinical trials investigating management of~     other lymph node fields.~   "
107007|NCT02166775|"~     In this trial, the correlation between the psychopathological profile and sagittal balance~     unexplored to date spine will be studied. Indeed, a number of patients who benefited from~     well-conducted surgical treatment, targeted and tailored to their pathology, respond poorly~     to it. The investigators wonder if there are biomechanical factors or factors of~     psychopathological order which might influence the effectiveness of treatment. This seems~     logical for the entire medical community, but it has never been demonstrated in a clinical~     trial.~   "
107008|NCT02166762|"~     This is a prospective clinical trial to determine the optimal QLV interval during~     implantation to achieve the best possible response from cardiac resynchronization therapy for~     heart failure patients.~   "
107009|NCT02166749|"~     The purpose of this study was to find out subjective and objective outcomes of patients~     undergoing subtotal or total abdominal hysterectomy during a follow up of a mean 33 years~     after the operation. The hypothesis is that there are similar outcomes after both types of~     operations.~   "
107010|NCT02166736|"~     Previous trials have demonstrated that the use of physiological assessment of stenosis~     severity using fractional flow reserve (FFR) is superior to angiographic assessment in~     percutaneous coronary intervention (PCI) and improves clinical outcome. Despite the clinical~     utility, FFR is used only in 10-15% of patients today. The main reasons for the low adoption~     rate of FFR are the prolonged procedural time, Adenosine related discomfort and cost~     associated with Adenosine.~      Instantaneous Wave-Free ratio (iFR®) is a novel method to assess coronary lesions for~     functional significance. The main benefits of the method compared to FFR are that the~     measurement is instantaneous and does not require Adenosine infusion. Thus, the patient does~     not experience any discomfort from the measurement and procedural time could be shortened~     compared to when using FFR. This could potentially increase the adoption rate of physiologic~     assessment of coronary lesions.~      The aim of this trial is to compare the clinical outcome of patients assessed by iFR® with~     patients assessed by FFR.~      Furthermore, the trial will be conducted as a registry based randomized clinical trial (RRCT)~     which is a novel strategy to conduct clinical trials. The randomization will occur online in~     the Swedish angiography and angioplasty registry (SWEDEHEART) using a web based platform.~   "
107011|NCT02166723|"~     Patients with persistent irregular heartbeats also called persistent atrial fibrillation~     usually have a lower probability of curing their arrhythmia with ablation with heat called~     radiofrequency then those with paroxysmal atrial fibrillation, as previous studies have~     shown.~      The emerging ablation with freeze(cryoablation) has not been studied for persistent atrial~     fibrillation but has been proven to be efficient in the paroxysmal type.~      We hypothesized that persistent atrial fibrillation will have a freedom of recurrence rate of~     70% after use of cryoablation at one year of follow up.~   "
107012|NCT02166710|"~     Total knee arthroplasty (TKA) is a frequent and effective surgery for knee osteoarthritis.~     This major surgery is associated with a reduction in knee extensor muscle strength persisting~     several weeks after surgery. This decrease in strength correlates with poor functional~     recovery. Its cause is multifactorial, including a deficit of the quadriceps activation, an~     acute postoperative atrophy of the muscle and an important limitation related to~     postoperative pain.~      Peripheral nerve blocks using local anesthetics are frequently used for postoperative~     analgesia following TKA. Femoral nerve blockade reduces pain and opioid consumption and~     allows early passive mobilization after surgery. This block also facilitates functional~     recovery and allows early discharge from the hospital. However, blocks involving the proximal~     femoral nerve contribute to quadriceps weakness for the duration of nerve blockade.~     Quadriceps weakness, in turn, results in functional impairment and increases recovery time. A~     possible long-term quadriceps weakness associated with the femoral nerve block has even been~     suggested in a recently published abstract. Hence, there is a need for an alternative~     technique that could minimize postoperative pain as well as the femoral nerve block without~     causing weakness of the quadriceps muscle.~      Femoral nerve block performed at the level of the adductor canal seems to be a promising~     alternative to the classic inguinal approach of the femoral nerve block. Studies comparing~     femoral nerve block performed at the canal adductor level to the inguinal approach reported a~     similar quality of analgesia, a reduction in motor block and a better functional recovery in~     the early postoperative period in the canal adductor block group. The long-term effect of~     femoral nerve block performed at the level of the adductor canal on knee extensor strength~     after surgery remains to be studied.~      This study will assess knee extensor muscle strength (principally quadriceps muscle) at 24h,~     48h and 6 weeks following TKA in patients having a femoral nerve block at the adductor canal~     level compared to a simulated block.~      Hypothesis: The adductor canal block will allow superior recovery of knee extensor muscle~     strength when compared to a simulated block at 6 weeks after total knee arthroplasty.~   "
107013|NCT02166697|"~     The purpose of this survey is designed to investigate the treatment status of hypertensive~     patient with metabolic syndrome-related risk factors treated with candesartan cilexetil~     tablets (Blopress Tablets), as well as to assess relationships between risk factors (example,~     visceral fat accumulation) and the incidence of cerebrovascular/cardiovascular events in an~     exploratory manner.~   "
107014|NCT02166684|"~     The study aims to evaluate whether do-it-yourself devices for self-measuring health~     parameters by subjects can be used for obtaining useful data in scientific studies.~      Besides, the study aims to evaluate if increased awareness of own health status by~     self-monitoring health parameters also serves as motivational instrument for changing health~     behaviour.~   "
107015|NCT02166671|"~     This study will evaluate the humoral and cellular immune responses to a hepatitis B vaccine~     booster in healthy adults which received a full course of neonatal hepatitis B vaccination~     20-23 years ago.~   "
107016|NCT02166658|"~     Patients suffering from histologically or cytologically confirmed stage IV lung or breast~     cancer with progressive or recurrent brain metastases after prior external beam radiotherapy~     will receive treatment with cabazitaxel until progression of brain metastases (BM) or~     unacceptable toxicity.~   "
107017|NCT02166645|"~     The purpose of this study is to determine whether patient positioning (prone and supine~     positioning) contributes to the success of extubation in the immediate postextubation period~     of preterm infants.~   "
107018|NCT02166632|"~     The purpose of this study is to determine quantitative and qualitative differences in~     post-operative pain relief for patients undergoing primary total knee arthroplasty (TKA) who~     receive administration of a newly approved, long acting local anesthetic branded as ExparelTM~     (bupivacaine liposome injectable suspension) introduced by one of two different~     administration methods.~      Group 1 would receive a predetermined and standardized dose of ExparelTM introduced directly~     into the joint capsule at the conclusion of the surgery, effectively bathing the joint in~     anesthetic solution.~      Group 2 would receive the same predetermined and standardized dose of ExparelTM as a local~     infiltration anesthetic (LIA) by injecting it into the periarticular tissues in nine (9)~     standard sites at the conclusion of the surgery.~   "
107019|NCT02166619|"~     In this study, the investigators wondered whether bihemispheric transcranial direct current~     stimulation (tDCS) would be capable to potentialize the effects of physical therapy on upper~     limb rehabilitation of chronic stroke patients. Moreover, the study aims to investigate the~     pattern of physiological variables involved in the recovery of these patients. For this~     purpose, patients included will be submitted to 10 sessions with active or sham bihemispheric~     tDCS associated with intensive and individual physical therapy session.~   "
107020|NCT02166606|"~     The objectives of this registry are to~        1. Collect clinical data on Boston Scientific's ImageReady MR Conditional Pacing Systems~          involving the INGEVITY lead based on observations / events~        2. Gather data on actual number of MRI scans performed in the patient cohort implanted with~          an ImageReady system including information about scanned body parts.~        3. Collect physician feedback on lead handling with the INGEVITY lead~      in a real-life, market-released standard of care environment using devices on intended~     purpose and which are authorized to bear the CE (Communauté Européenne) marking / are~     approved for use in the applicable area of participating centers. No additional invasive or~     other burdensome examinations are to be carried out other than the ones conducted by the~     centers per their general standard of care.~   "
107021|NCT02166593|"~     1. Target disease : Patients with combined dyslipidemia with adequately controlled LDL-C~          but inadequately controlled triglyceride level by atorvastatin monotherapy~        2. Study objective : The objective of this study is to demonstrate that Pravafenix Cap. is~          clinically superior to atorvastatin by evaluating a percent change in Non-HDL-C in each~          group after 8 weeks treatment with atorvastatin or Pravafenix Cap. (pravastatin~          sodium/fenofibrate) in patients with adequately controlled LDL-C but inadequately~          controlled triglyceride level by atorvastatin monotherapy in a multicenter, randomized,~          double blind setting.~        3. Phase and design : A multicenter, double blind, randomized, active controlled,~          parallel-design, Phase 3 study~        4. Duration of study : 12 months from the IRB approval date~        5. Duration of administration : 4-week single blind run-in period plus 8-week double blind~          treatment period~   "
107022|NCT02166580|"~     Noninvasive pulse pressure variation for the guidance of perioperative fluid therapy is~     compared with the gold standard of invasive measurements. Cardiac output is derived by the~     PICCO monitor.~      Hypothesis: Noninvasive CNAP PPV predicts fluid responsiveness. A grey zone for the~     prediction of fluid responsiveness will be defined.~   "
107023|NCT02166567|"~     In assisted reproductive technology (ART) semen needs to be processed. Commonly used methods~     rely on physical properties of the spermatozoa, such as the swim-up methods and density~     gradient centrifugation. It is now known that current processing of spermatozoa does not~     prevent the admixture of spermatozoa with damaged genetic material. The latter have a~     negative impact on the outcome of ART. The investigators developed a new method for the~     processing of spermatozoa with intact genetic material based on flow cytometry and sorting~     (FACS) and on staining using a deye, YoPro. The investigators aim at examining the effect of~     this novel method of sperm sorting on the outcome of ART.~   "
107024|NCT02166554|"~     The purpose of this study was to determine whether the new crosslinked hyaluronan hydrogel~     was safe to use, and was effective for the prevention/reduction of adhesion formation~     following gynecological surgery~   "
107025|NCT02166541|"~     A randomized control trial investigating Biomechanical Correction of the Spine according to~     Kozyavkin (BCSK) which is a part of the treatment concept Intensive Neurophysiological~     Rehabilitation System (INRS). BCSK is used with the aims to reduce muscle tone and improve~     gross and fine motor function in children with Spastic Bilateral Cerebral Palsy.~   "
107026|NCT02166528|"~     Female pelvic floor dysfunction (FPD) is due to defects in the pelvic support structures,~     degradation, damage or dysfunction. The main problem of which is pelvic organ prolapse(POP),~     urinary incontinence(UI) and genital tract injury. Although it does not pose a serious threat~     to life, but affect the patient's quality of life seriously in the physical, psychological,~     social behavior and other aspects. With the growing aging population, the incidence rate has~     gradually increased, and increasing demands for people's quality of life simultaneously, more~     and more attention was raised to PFD as common chronic diseases.~      In recent years, the basic research, epidemiology, prevention, diagnosis and treatment of PFD~     have made great progress, especially in developing gynecological urology theory and~     reconstructive pelvic surgery. But overall the basic research of PFD is lagging behind,~     especially susceptibility gene localization and functional studies did not get enough~     attention.~   "
107027|NCT02166515|"~     As human aging, 50% of women will be faced with the threat of cancer, especially~     gynecological malignancies. Ovarian, cervical and endometrial cancer are three major~     gynecological malignancies. In recent years, the incidence of cervical cancer, especially in~     young women significantly increased; ovarian cancer, although the incidence of malignant~     tumors in the female reproductive system ranked second, but its mortality rate already in the~     first place; and the morbidity and mortality of endometrial cancer is also rising.~      The key to gynecologic malignancies is how to early diagnose and treat. With the advancement~     of science and technology, such as molecular biology techniques widely used in the medical~     field, early diagnosis, proper treatment and other aspects in gynecologic malignancies is~     expected to achieve a breakthrough. Genome-wide scan strategy, making the whole genome for~     linkage analysis for gynecological malignancies possible. Therefore, the investigators intend~     to find specific mutations to provide a new early screening approach for gynecological~     malignancies, which in later result in early diagnosis and specific treatment for~     gynecological malignant tumors.~   "
107028|NCT02166502|"~     The purpose of this study is to determine whether the current dose of nevirapine recommended~     in the Ontario Ministry of Health vertical transmission prevention protocol achieves~     therapeutic drug levels in newborn infants at high risk of HIV infection.~   "
107029|NCT02166489|"~     This study was designed to provide confirmation of safety of mesenchymal stem cells (MSCs)~     therapy in chronic renal failure due to autosomal dominant polycystic kidney disease (ADPKD).~   "
107030|NCT02166476|"~     Meropenem-vaborbactam is being compared to piperacillin-tazobactam in the treatment of adults~     with complicated urinary tract infection (cUTI) or acute pyelonephritis (AP).~   "
107031|NCT02166463|"~     This randomized phase III trial studies brentuximab vedotin and combination chemotherapy to~     see how well they work compared to combination chemotherapy alone in treating children and~     young adults with stage IIB or stage IIIB-IVB Hodgkin lymphoma. Combinations of biological~     substances in brentuximab vedotin may be able to carry cancer-killing substances directly to~     Hodgkin lymphoma cells. Drugs used in chemotherapy, such as doxorubicin hydrochloride,~     bleomycin sulfate, vincristine sulfate, etoposide, prednisone, and cyclophosphamide, work in~     different ways to stop the growth of cancer cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. It is not yet known if combination~     chemotherapy is more effective with or without brentuximab vedotin in treating Hodgkin~     lymphoma.~   "
107032|NCT02166450|"~     The aim of this study is to evaluate the influence of presence of oral fungal infection,~     which leads to denture-related stomatitis, on blood pressure, endothelial function and immune~     cell phenotype in patients wearing dentures.~   "
107033|NCT02166437|"~     In this study, the investigators would like to analyze the bone mineral density (BMD) , bone~     turnover makers, and fracture prevention effects of bisphosphonate and denosumab randomly~     divided following daily teriparatide in Japanese patients under clinical practice. The~     participants are treated in the investigators hospital, who are under severe osteoporotic~     condition.~   "
107034|NCT02166424|"~     The present study aims to examine the efficacy and safety of omega-3 polyunsaturated fatty~     acids for pregnant women with depressive symptoms.~   "
107035|NCT02166411|"~     The aim of this study is to compare operative data and early postoperative outcomes of~     laparoscopic myomectomy using barbed sutures with those of laparoscopic myomectomy using~     conventional sutures .~   "
107036|NCT02166398|"~     A randomized, open-label, single dose, two-way crossover clinical trial to compare the~     safety, pharmacokinetic profiles of UI15AML055MT and Amosartan® tablet 5/50 mg after a single~     oral administration in healthy male volunteers~   "
107037|NCT02166372|"~     T2DM has become a major health burden for our society. More and more data support the~     relative effectiveness of gastrointestinal metabolic surgery, known as bariatric surgery, in~     the remission of T2DM of BMI less35. The metabolic surgery guidelines of IDF recommend BMI~     over 27.5 in Asia.~      The evidence reviewed above strongly points to the need for a large randomized, controlled~     trial to evaluate the risks and benefits of obesity surgery in the treatment of type 2~     diabetes Mellitus. This study is expected to provide very significant findings about the~     natural course of diabetes in obese diabetic patients.~   "
107038|NCT02166359|"~     Patients with chronic kidney disease (CKD) have a markedly higher prevalence of~     cardiovascular disease (CVD) than the general population. Dyslipidemia is considered a major~     cause of CVD in patients with CKD. Especially for peritoneal dialysis (PD) patients, the use~     of glucose as the osmotic agent in PD solutions has been associated with a variety of~     metabolic consequences ranging from acute hyperglycemia and hyperinsulinemia to dyslipidemia~     and weight gain. Among lipid abnormalities, hypertriglyceridemia is the most common in PD~     patients. A study showed that patients with high triglyceride levels were more~     insulin-resistant than those with normal triglyceride levels.~      Insulin resistant is associated with atherogenic response represented high plasma levels of~     monocyte chemotactic protein-1 in a large cohort of dialysis patients. Therefore, high~     triglyceride level may play an important role to CV outcome of PD patients. PD solution~     decreasing triglyceride levels is essential in PD patients.~      Icodextrin, a starch-derived high molecular weight glucose polymer was found to increase~     ultrafiltration compared to glucose solutions. Furthermore, a low peritoneal absorption of~     icodextrin, which is catabolized into maltose, considerably reduces caloric uptake.~     Therefore, icodextrin may have an additional favorable effect on triglyceride level.~      There are several studies regarding the effect of icodextrin on triglyceride level in PD~     patients. However, the outcomes are controversial, some studies showed no association between~     icodextrin and triglyceride change, even the others showed positive results but these also~     have study design limitations such as non-randomized study or secondary primary outcome. It~     is not clear about the effect of icodextrin on triglyceride especially in PD patients without~     diabetes.~      The investigators therefore want to conduct a randomized, cross-over, controlled multicenter~     trial comparing icodextrin solution and glucose solution in PD patients with and without~     diabetes, focusing on triglyceride change.~   "
107039|NCT02166346|"~     Transverse myelitis (TM) is an inflammatory disorder of the spinal cord that leads to~     disabilities of gait. Dalfampridine, a sustained-release potassium inhibitor has been shown~     to be effective in improving gait and other neurologic functions in multiple sclerosis.~     Dalfampridine has the potential to improve neurologic function in patients with transverse~     myelitis as this rare disorder shares a similar pathogenic process with multiple sclerosis.~     The in a clinical trial to test the efficacy of dalfampridine in TM.~      The clinical trial that the investigators propose to conduct will focus on TM and will~     evaluate the dalfampridine in primary neurologic outcome, 25-foot timed walk, and several~     secondary outcomes including valid behavioral and neurophysiological tests.~      This is a re-launch of the previous trial, which now includes additional behavioral and~     clinical testing.~   "
107040|NCT02166333|"~     Vitamin D supplements might substantially reduce the risk of falls, potentially by more than~     25%. The proposed study is a clinical trial that will determine the effects of 4 doses of~     vitamin D (200 International Units [IU]/day, 1000 IU/day, 2000 IU/d and 4000 IU/d) as a means~     to prevent falls in high-risk adults, ages 70 and older. Results of this trial will be~     directly relevant to public health and clinical guidelines, and will immediately influence~     policy.~   "
107041|NCT02166320|"~     Self expandable stent (SEMS) constitutes the main palliative treatment in advanced esophageal~     cancer. The palliative effect of SEMS is immediate when it comes to relief of dysphagia. The~     duration of this effect is however questionable. The design of SEMS can be of importance~     since the device can dislodge and as a consequence of that dysphagia recur. The hypothesis~     has therefore been formulated that a partially covered SEMS is associated with less tendency~     to dislocate as compared to those SEMS, recently developed, which are covered through their~     entire length.~   "
107042|NCT02166307|"~     Aging in human physically refers to a multidimensional process that all the changes were~     accumulated in a person over time. These aging changes are responsible for the progressive~     increases in the chance of disease and death associated with them. So far, there are several~     theories have been developed to understand the aging process, such as cross-linking, which is~     led by Maillard Reactions. Maillard Reaction is a complex series of reactions between~     reducing sugar/aldehydes and amino groups on proteins. Under physiological conditions,~     aldehydes are products of various exogenous and endogenous amines catalyzed by~     semicarbazide-sensitive amine oxidase (SSAO), a family of heterogeneous enzyme. It was~     reported that SSAO shows a significant higher catalytic activity, producing more aldehydes in~     age-related diseases. However, SSAO is not a perfect candidate to be monitored for evaluating~     aging, because it is widely distributed in tissues, which are not readily accessible~     sample-sources for clinical applications. In this work, the investigators have found 6~     biomarker candidates by developing a standard-free, label-free MS-based proteomics method~     based on standard protein (human serum albumin, the highest abundance protein in human~     plasma) model in vitro. Then, the investigators wanted to verify these biomarker candidates~     by clinical plasma samples to see if there is significant quantitative difference among~     people with different ages.~   "
107043|NCT02166294|"~     In this randomized, multi-center, cross-over study, the efficacy and safety of NEOX® CORD 1K~     will be evaluated in patients suffering from non-healing diabetic foot ulcers. NEOX® CORD 1K~     is a cryopreserved human Amniotic Membrane and Umbilical Cord (AM/UC) matrix intended for use~     as a wound covering for dermal ulcers and defects. It is designated as a Human Cell & Tissue~     Product (HCT/P) by the U.S. FDA.~   "
107044|NCT02166281|"~     Insomnia is common in Breast cancer patients during adjuvant therapy with aromatase~     inhibitor.~      However it is difficult to establish whether it is due to the knowledge of the disease or the~     treatment administred.~      The investigators designed a cohort study in which questionnaires for the assessment of sleep~     quality (Pittsburgh Sleep Quality Index and Insomnia Severity Index), anxiety (State and~     Trait Anxiety Inventory), depression (Beck Depression Inventory), for the quality of life in~     general (Functional Assessment of Cancer Therapy) and for the evaluation of RLS (Restless~     Legs Syndrome Rating Scale) will be prospectively administered to patients with early breast~     cancer at baseline and during adjuvant treatment with aromatase inhibitors.~      As secondary aims the investigators will also evaluate dietary and lifes' factors, born turn~     over and BMI.~   "
107045|NCT02166268|"~     The clinical trial will investigate the efficacy of Avanz Phleum pratense in the treatment of~     rhinitis in an environmental challenge chamber.~   "
107046|NCT02166255|"~     This phase I trial studies the side effects and best dose of small interfering ribonucleic~     acid (siRNA)-transfected peripheral blood mononuclear cells APN401 (APN401) in treating~     patients with melanoma, kidney, or pancreatic cancer, or other solid tumors that have spread~     to other parts of the body or that cannot be removed by surgery. There are factors in immune~     cells in the blood that inhibit their ability to kill cancers. Treating white blood cells~     with one of these factors in the laboratory may help the white blood cells kill more cancer~     cells when they are put back in the body.~   "
107361|NCT02162121|"~     Stimulating catheters have been introduced to reduce the incidence of secondary failure after~     continuous peripheral nerve blocks, but they effectiveness over traditional nonstimulating~     catheters is still controversial. The aim of this prospective, randomized, blinded study is~     to detect if stimulating catheters improve postoperative compared with conventional~     non-stimulating catheters.~   "
107047|NCT02166242|"~     Thioredoxin reductase plays an critical role in lung cancer patients, in vitro study showed~     that, ethaselen, specific inhibitor of thioredoxin reductase, could inhibit lung cancer cell~     growth and induce apoptosis. In China, phase 1 clinical trials of ethaselen showed that 1200~     mg dose ethaselen could be well tolerated, in pre-clinical study we found that, approximately~     50% non-small cell lung cancers harbored high thioredoxin reductase expression(IHC result ++~     or +++), phase 1a/b of ethaselen had finished in 2008, the result showed that 1200mg~     ethaselen per day was safety and tolerated by Chinese malignant tumor patients.In~     pre-clinical research, our group found that, elevated of thioredoxin reductase activity was~     associated with the expression of thioredoxin reductase tested by immunohistochemistry, which~     means high expression of this enzyme may be a favourite predicted factor of ethaselen, the~     specific inhibitor of thioredoxin reductase.~   "
107048|NCT02166229|"~     To investigate the ability of divalproex sodium, a histone deacetylase inhibitor, to improve~     the digital manifestations of scleroderma including digital edema, calcinosis cutis, digital~     ulcers, and joint contractures.~   "
107049|NCT02166216|"~     Competitions such as marathon running and endurance cycling events are increasingly popular~     and represent an important motivation for sustaining training among leisure-time athletes.~     However, there is a concern that prolonged, high-intensity exercise may increase the risk of~     cardiovascular (CV) events. Following prolonged high-intensity exercise there is an increase~     in levels of circulating markers of myocardial damage such as Troponin I (TnI). The precise~     cause and clinical significance of this TnI increase is unknown.~        -  The primary objective of this study was to determine the relationship between~          high-sensitive cardiac troponin I (hs-cTnI) levels and coronary artery disease and~          cardiovascular outcomes in 1000 presumably healthy leisure sport athletes that~          participated in a 91 km long, high intensity endurance cycling competition.~        -  The secondary objective was to assess the relationship between other CV risk factors,~          fitness level and outcomes following high intensity endurance cycling competition in the~          same population.~   "
107050|NCT02166190|"~     Malignant obstructive jaundice is a common complication of advanced stage pancreatic~     adenocarcinoma and cholangiocarcinoma. Over 50% of common bile duct (CBD) obstructions are~     due to malignancy, and the majority of neoplasms are unresectable at the time of diagnosis.~     Biliary drainage with placement of self-expanding metal stents (SEMSs) for palliation is the~     therapy of choice in this set of patients. Conventional stent placement provides palliation~     for a limited duration only and these subjects come back with obstructive jaundice. Due to~     age, comorbidities, malignant disease status, it is better to conduct reduced number of~     therapeutic endoscopies to reduce the number of complications. Additionally, only biliary~     stenting itself may provide only palliation, and not increase the duration of survival.~      Currently, there are only two therapies. Recently, photodynamic therapy (PDT) has been~     evaluated as a palliative and potential neoadjuvant modality. Therefore if RFA confers~     similar benefits, then it may potentially be used as an alternative to PDT, given the lower~     adverse event profile. More recently, RFA has been recognized for its potential in palliative~     treatment of malignant biliary strictures. Based on the published data, RFA provides~     palliation and seems to increase survival duration in pancreatic cancer. Our own limited~     experience shows the same. The goal of this randomized controlled trial is to definitely~     confirm the benefit of Radiofrequency ablation (RFA) in providing increased survival time and~     quality of life in patients with non-resectable cholangiocarcinoma and pancreatic cancer.~     These benefits will improve clinical practice by making RFA the new standard of care for~     unresectable cholangiocarcinoma (CCA) and pancreatic cancer (PC). It will also enhance~     scientific knowledge by opening the door for new opportunities, e.g. RFA as a potential use~     for neoadjuvant therapy or as a downstaging agent for surgically resectable patients.~   "
107051|NCT02166177|"~     'ThRIL' aims to explore the feasibility, safety and efficacy of TR002, a regulatory cell~     therapy, as adjunct immunosuppressive treatment in the context of liver transplantation~   "
107052|NCT02166164|"~     In this prospective trial we aim to investigate the intra-individual and inter-individual~     variance in secondary hyperalgesia following pain elicited by the experimental pain model:~     Brief Thermal Sensitization.~      Furthermore we wish to investigate how precise the psychological tests, Pain Catastrophizing~     Scale and Hospital Anxiety and Depression Scale predict the size of the area of secondary~     hyperalgesia.~   "
107053|NCT02166151|"~     The study is designed to assess the efficacy and safety of monthly injections of Omalizumab~     150 mg for 3 consecutive months, in patients with chronic idiopathic urticaria, unresponsive~     to convetional therapy by antihistamins or oral corticosteroids.~   "
107054|NCT02166138|"~     The condition to be studied is post-surgical scarring following primary total knee~     replacement, specifically whether fractional non-ablative laser therapy can be used to~     significantly decrease the morbidity of scarring.~   "
107055|NCT02166125|"~     The purpose of this prospective registry is to assess long term data on efficacy, safety and~     clinical outcome of endoscopic placement of suture(s) and approximation of soft tissue within~     the Gastrointestinal tract for various GI tract disorders. The registry will evaluate~     technical feasibility, clinical outcome, safety profile and overall clinical management~     through medical chart review. The procedures the investigators are evaluating are all~     clinically indicated and will not be prescribed to someone to participate in this research~     study.~   "
107056|NCT02166112|"~     Incisional hernia is the most frequently seen long term complication in surgery causing much~     morbidity and even mortality in patients. Despite studies on the optimal closing technique~     for laparotomies, the risk for incisional hernia after midline incision remains about 5-20 %.~     It has been established that implementing a mesh reduces recurrence of the incisional hernia~     but still the results of repair are often disappointing. Incisional hernias can become~     increasingly complex due to complicated abdominal wall defects caused by a disturbed anatomy,~     fistulas, burst abdomen, wound and mesh infections. In these cases it is not save to repair~     the incisional hernia by means of a synthetic mesh and other augmentation tools need to be~     implemented.~      In the recent years the use of biological meshes has been gaining popularity. Recent reports~     of the use of collagen-based prosthesis have suggested that they support new vessel growth,~     do not excite a significant foreign body reaction, form fewer adhesions, are well~     incorporated into host tissues with minimal wound contraction, and can be used in grossly~     contaminated wounds with fewer infective complications. Biologic meshes are harvested from a~     source tissue and processed for medical use but they vary widely in their processing methods.~     They include tissues of human or animal origins, both chemically cross-linked and non~     cross-linked processes, and submucosal, pericardial, or dermal tissue sources. Current~     studies investigating the effectiveness of these meshes are small and have short periods of~     follow-up. These shortcomings can be explained to high cost of the meshes and unclear~     indication when to use a biological mesh.~      The aim of this study is investigate the short and long term effects of the Permacol©~     biological mesh. Also the investigators will be inquiring why a biologic mesh was used, what~     is the true indication to use a biological mesh.~   "
107085|NCT02165722|"~     The purpose of this study is to test whether or not the 4 Pillars Immunization Toolkit~     increases adolescent vaccination rates, particularly influenza and human papillomavirus (HPV)~     but also tetanus, diphtheria and pertussis (Tdap), and meningococcal conjugate (MCV)~     vaccination rates. The vaccines are all FDA licensed vaccines and to be used according to~     national guidelines. The investigators will conduct a randomized cluster trial of this~     toolkit in diverse primary care practices with electronic medical records (EMRs).~   "
107057|NCT02166099|"~     The purpose of this registry is to record information and evaluate the impact of SpyGlassTM~     Direct Visualization System for choledochoscopy on the management of pancreatico-biliary~     disorders. The registry will evaluate diagnostic performance and overall clinical management~     impacted by SpyGlass.~      This multi-center registry has been initiated:~        -  To document the impact of SpyGlass Choledochoscopy in pancreatico-biliary disorders on~          the clinical management of pancreatico-biliary disorders including malignancies.~        -  To assess the sensitivity, specificity, accuracy, technical feasibility, safety and cost~          effectiveness of SpyGlass and compare it to other diagnostic modalities.~   "
107058|NCT02166086|"~     The purpose of this registry is to record information and evaluate the impact of advanced~     imaging techniques on the management of pancreatico-biliary disorders. The registry will~     evaluate diagnostic performance and overall clinical management impacted by advanced imaging~     techniques.~   "
107059|NCT02166060|"~     The purpose of this study is to determine the role of ivabradine in cardiac resynchronization~     recipients with an unsatisfactory percentage biventricular pacing.~      The study protocol 60 patients with heart failure NYHA (New York Heart Association) II-IV~     treated with optimal medical therapy as clinically indicated who received CRT-D device more~     than 3 months ago. Patients with biventricular pacing <95% will and heart rate <70 at rest~     and >50% of heart rate in device memory >70 will receive ivabradine. The minimal follow-up of~     patients in the study will be at least six months.~   "
107060|NCT02166047|"~     This study will evaluate the safety, tolerability, and efficacy of GS-9620 in virologically~     suppressed adults with chronic hepatitis B virus (HBV) infection who are currently being~     treated with oral antivirals (OAV). Participants will be randomized in 3 sequential cohorts.~     Within each cohort, participants will be randomized in a 1:3:3:3 ratio to placebo or one of~     the doses of GS-9620 (1, 2, or 4 mg) and all participants will continue on their current oral~     antiviral treatment for the entire duration of the study. Cohorts A, B, and C will consist of~     a different treatment period of 4, 8, or 12 weeks, respectively, and will be followed to Week~     48. After Cohort A completes treatment, a safety review will be conducted by an external data~     monitoring committee prior to beginning Cohort B. Another safety review will be conducted~     after Cohort B completes treatment prior to beginning Cohort C.~   "
107061|NCT02166034|"~     The purpose of this study is to determine whether school gardens influence children's dietary~     intake, nutritional knowledge, and other outcomes.~   "
107062|NCT02166021|"~     The purpose of this study is to to evaluate the optimal dosage and the way of administration~     of autologous mesenchymal bone marrow stem cells (MSC) either in maximal proximity of the~     lesions in the CNS or by intrathecal injection to the CSF.~   "
107063|NCT02166008|"~     -  Primary objective : To evaluate the efficacy of Rapamide in peptic ulcer prevention in~          patients taking dual antiplatelet agents~        -  Study Design: Single center, double-blind, randomized-control trial study~        -  Study drug: Repamipide vs. placebo~        -  Assessment criteria The patients will be discharged from the study when one of the~          followings occurred,~             1. Peptic ulcer from upper endoscopy at 3 and 6 month follow up~             2. Clinical of upper gastrointestinal bleeding with peptic ulcer from upper endoscopy~             3. Anemia by CBC at 1,3 ,6,12 month with peptic ulcer from upper endoscopy~             4. Evidence of recurrent myocardial infarction from stent thrombosis~   "
107064|NCT02165995|"~     The goal of this clinical research study is to learn about using Navigated Transcranial~     Magnetic Stimulation (nTMS) in patients having surgery to remove a brain tumor in areas of~     the brain that control movement (motor function) and/or speech.~      nTMS is a system designed to map the brain's function relating to movement and speech.~   "
107065|NCT02165982|"~     Etude d'épidémiologie clinique multicentrique (IMM), naturalistique, comparant un échantillon~     clinique à un échantillon de témoins issus de la population générale.~      Cette recherche se fixe pour objectif principal de déterminer, sur un large échantillon de~     patients pris en charge pour anorexie mentale dans des unités de soins spécialisées, les~     caractéristiques de l'activité physique et la dépendance à l'exercice physique en comparaison~     avec des sujets issus de la population générale appariés pour l'âge et le sexe.~      Nous faisons l'hypothèse que les patients anorexiques mentaux sont plus actifs et plus~     dépendants à l'exercice physique que des sujets de la population générale de même âge et de~     même sexe.~   "
107066|NCT02165969|"~     The purpose of this study is to compare a subject's sense of smell before and after~     endoscopic endonasal surgery to remove a skull base abnormality (i.e. tumor, inflammatory~     process, fracture, defect, etc.) and use the information collected to validate approaches to~     surgery that will minimize side effects to the sense of smell function. Data will be~     collected using a smell identification test along with two questionnaires. In addition,~     demographic, medical history, treatment, outcome, and follow-up information will be~     collected.~   "
107067|NCT02165956|"~     The purpose of this study is to determine whether a new infant cereal has an effect on weight~     gain and intestinal microbiota compared to a standard cereal in healthy infants .~   "
107068|NCT02165943|"~     This is a retrospective, two-arm study reviewing the healing of cavitary defects in patients~     treated with Vitoss alone versus those treated with Vitoss with bone marrow aspirate (BMA).~     There will be a prospective follow-up visit at 24+ months to evaluate lont-term healing in~     patients identified during the retrospective portion of the study. It is thought that the~     inclusion of BMA will facilitate the resorption of the graft material, leading to better~     long-term bone healing.~   "
107069|NCT02165930|"~     To Estimate Bioavailability Of 40 Mg Doses Of Pf-00345439 Formulation K Under Fasting~     Conditions with 40% Ethanol Compared with Water in Healthy Volunteers~   "
107081|NCT02165774|"~     Prospective, randomized, placebo-controlled, double-blind multicenter trial including 4~     tertiary sacral neuromodulation referral centers in Switzerland (Zürich, Bern, Nottwil,~     St.Gallen). Patients with refractory neurogenic LUTD are included and randomized after~     neuromodulator implantation into sacral neuromodulation ON or sacral neuromodulation OFF~     (n=30) for a 2 months double-blind phase. In addition to standard neuro-urological~     assessments, patients who agree will also undergo neurophysiological investigation of the~     lower urinary tract, i.e. recording of current perception thresholds, sensory evoked~     potentials, and electroencephalography after stimulation of the urethra and bladder.~   "
107070|NCT02165917|"~     Endometriosis is a common disease of women in the reproductive age and is an important cause~     for female infertility. Endometriosis is often associated with the development of adhesions~     which further compromises the fertility of the affected women. The main purpose of this study~     is to investigate the pregnancy rate one year after excision of endometriosis and application~     of GnRH-analogues (Gonadotropin-releasing hormone) for 3 month. Half of the patients will~     receive traditional endometriosis treatment with the excision of the endometriotic lesions~     only. The other half will additionally receive a gel which can reduce adhesion formation~     (Hyalobarrier®). Further study objective is the investigation in the development of different~     types of endometriosis-associated pain over a period of one year. Potential study~     participants are women with endometriosis-associated pain and with a desire to have children.~     It will be investigated in the study if the use of Hyalobarrier® will result in a higher~     pregnancy rate due to reduced adhesion development.~   "
107071|NCT02165904|"~     The study goes on 24 months, with recruiting, treatment and follow period for all patients.~     The first day for each patient will be the first cellular administration. 3 doses will be~     administrated every 3 months from first dose.~      When the clinical trial finishes, it will be done a completed check of all obtained~     parameters.~   "
107072|NCT02165891|"~     Despite the improvement in the technology available for diagnosing and treating empyema, the~     management of empyema in children remains controversial.~      The purpose of this study is to compare the efficacy and safety of two common technical~     approach used for pleural effusion drainage in the treatment of childhood empyema.~   "
107073|NCT02165878|"~     KNOW-CKD (KoreaN cohort study for Outcome in patients With Chronic Kidney Disease) is a~     nation-wide, ten-year longitudinal cohort study, launched in 2011. The aim of the study is to~     assess the characteristics and risk factors of progression and complications of CKD of Korea.~     Pediatric sub-cohort of KNOW-CKD is planned to enroll 450 children with CKD, stage I to V~     (pre-dialysis).~   "
107074|NCT02165865|"~     The Southern Illinois University (SIU) Hand Transplant Program is a multidisciplinary~     research effort with the goal of restoring form and function to unilateral or bilateral upper~     extremity amputees by vascularized composite allotransplantation of the hand/upper extremity~     (hand transplantation). Hand transplantation includes transferring upper extremities/hands~     from deceased human donors to patients with single or bilateral hand or arm amputation. The~     purpose of the trial is to study functional, psychological, and immunological outcomes of~     human upper extremity allotransplantation.~   "
107075|NCT02165852|"~     Because the ampulla of Vater is strategically located at the confluence of the pancreatic and~     common bile ducts, endoscopic resection of papillary neoplasms may be technically different~     from endoscopic mucosal resection in other parts of the gastrointestinal tract. The best~     method of endoscopic ablation and the optimal period for surveillance have not been~     established.~   "
107076|NCT02165839|"~     PRIMARY OBJECTIVE(S):~      The purpose of this study is to test the efficacy of brief behavioral therapy versus control~     condition that accounts for time and attention (nutrition education) in the treatment of~     insomnia in humans.~      SECONDARY OBJECTIVE(S):~      To assess the impact of different biomarkers on sleep disruption and other patient reported~     outcomes~   "
107077|NCT02165826|"~     The purpose of this study is to evaluate discontinuation rates of roflumilast using an~     up-titration regimen for the first 4 weeks of treatment compared with continuous treatment of~     500 μg one daily (OD) during the entire 12-week main period, and to evaluate if participants~     who do not tolerate roflumilast 500 μg OD have a drug exposure with 250 μg roflumilast OD~     similar to that observed in other participants with the 500 μg OD dose.~   "
107078|NCT02165813|"~     This is a multi-centre (RDH and ASH), phase IV, double-blind, randomised, placebo-controlled~     trial of oral NTZ for the treatment of acute gastroenteritis requiring admission to hospital.~     Four hundred children aged between three months and less than five years of age will be~     enrolled. Study participation would be from the point of enrolment until 60 days after~     enrolment. Enrolment will occur within 48 hours of admission to hospital. Enrolled~     participants will be randomised 1:1 to Nitazoxanide (NTZ) or placebo. Other treatment and~     management will be as per the standard of care described in the admitting hospital's~     guidelines and will be ultimately the decision and responsibility of the named medical~     consultant. Stool samples will be collected at the point of admission. Solicitation of~     symptoms will be by review of routinely collected medical data recorded in the participant's~     medical record, and will be supplemented by completion of study specific diary cards until~     discharge. All participants will be followed up at day 7 after enrolment (by telephone if~     already discharged) to ascertain symptoms occurring in the intervening period. At days 30 and~     60 after enrolment a clinical record review will be conducted for all participants to~     ascertain health care attendances following discharge.~   "
107079|NCT02165800|"~     TME (Total mesorectum excision) is the golden standard of radical resection for mid-low~     rectal cancer. However, the damage of pelvic autonomic nerve following with TME principle~     will lead to high incidence of urinary and sexual function disorder. Open PANP (pelvic~     autonomic nerve preservation) TME surgery played a role in decreasing incidence of urinary~     and sexual function disorder. However, 32%-44% patients still suffered from urinary and~     sexual function disorder when underwent Open PANP TME surgery (O-PANP-TME).~      Laparoscopy-assisted TME surgery (L-TME) is applied wildly nowadays. In the early stage of~     work, we performed laparoscopy-assisted PANP TME surgery (L-PANP-TME) to discuss the~     protection of urinary and sexual function of male mid-low rectal cancer patients. The results~     showed that L-PANP-TME significantly decreased incidence of urinary and sexual function~     disorder. In order to further confirm our early work, we design a multiple-center randomized~     controlled clinical trial to compare differences in urinary and sexual function protection~     and long-term outcomes between L-PANP-TME and O-PANP-TME.~   "
107080|NCT02165787|"~     In the cross-sectional component of this study, our overall objective is to gather a large~     pool of data from which we can generate gait profiles. These profiles will consist of a~     constellation of gait (+/- electrophysiological) parameters associated with a particular~     neurological diagnosis or specific lesion(s) in neuroanatomical systems. Once developed,~     these profiles can be compared for differences and similarities; allowing insights into the~     specificity of the effect on gait of a given diagnosis or lesion in the case of the former~     and redundancy of neuroanatomical systems in that of the latter. A longitudinal component of~     the study will look at the evolution of gait parameters over time in a group of patients with~     spinal cord injury.~   "
107087|NCT02165696|"~     Lymphedema is the result of accumulation of fluid and other elements in tissue spaces because~     of an imbalance between the production of fluid interstitial and transport. Lymphedema can~     cause significant physical and psychological morbidity. Prevalence of lymphedema in patients~     after breast cancer surgery is 12-60% and the incidence is 12-26%.Psychological and social~     consequences of secondary lymphedema related breast cancer have been little recognized and~     documented. Although, it have performed many studies related secondary lymphedema it not~     found sufficient evidence in the literature to suggest the most effective treatment. There is~     some evidence suggesting that compression therapy and manual lymphatic drainage can improve~     lymphedema but more studies are needed. The aim of this research is to to evaluate the~     clinical effect of multimodal treatment (compression bandaging and manual lymph drainage)~     versus applying manual lymphatic drainage in women with arm lymphedema after breast cancer~     surgery.~   "
107088|NCT02165683|"~     This is a single-arm, open-label study to assess the safety and effectiveness of a single~     dose of oral propranolol in reducing18F-fluorodeoxyglucose (FDG) uptake in brown adipose~     tissue (BAT) in pediatric oncology patients. This study is designed to better understand if~     taking a single dose of an oral medication called propranolol can reduce the chance of brown~     fat showing up on a PET scan, and therefore make the scan more accurate and easy to~     interpret. All humans have some degree of normal brown fat (called brown adipose tissue), and~     this normal tissue can sometimes light up on a PET scan. That creates problems because it may~     be wrongly interpreted by the radiologist as tumor, or it may hide true areas of tumor~     underneath it. Participants will not be randomized and will receive a single dose of oral~     propranolol approximately 60 minutes prior to the injection of the FDG tracer. The dose of~     propranolol will be 20 mg for all participants.~   "
107089|NCT02165670|"~     BASIC VALIDATE is a coronary stent registry to obtain clinical follow-up information from~     2000 patients treated with CE-marked stent (BioMatrix Flex™, Biosensors International) with~     follow-up of endpoints via the Swedish angiography and angioplasty registry (SCAAR - part of~     the national SWEDEHEART registry).~   "
107090|NCT02165657|"~     The overall aims for this study are to determine whether UVB excimer laser treatment of~     psoriasis affects serum inflammatory markers, and to assess hyperpigmentation and erythema~     with excimer laser treatment.~      The investigators hypothesize that treatment of psoriasis with UVB delivered via 308 nm~     excimer laser will decrease the levels of serum inflammatory markers. The investigators~     hypothesize that treatment will decrease plaque erythema and will result in minimal~     hyperpigmentation.~   "
107091|NCT02165644|"~     Subarachnoid Hemorrhage (SAH) can occur commonly in the setting of trauma or brain aneurysm.~     SAH accounts for 10% of all the strokes. Aneurysmal SAH accounts for 80 % of cases of~     non-traumatic cases of SAH, 6-8% of all strokes and 22-25% of all cerebrovascular deaths.~     Mortality can be 50% in the first few years of aneurysmal SAH rupture, 15% are severely~     disabled post SAH and only 20-35% having a moderate to good recovery it has gained lot of~     attention and pre-clinical and clinical trials of various agents have been tried to prevent~     poor outcome. The United States epidemiology data reveals the fact that 1% to 5% of adults~     have unruptured brain aneurysm and 30,000 people suffer from aneurysm rupture annually~     translating to brain aneurysm rupture every 18 minutes.~      Vasospasm is the most common SAH complication post 24 hours. It is the segmental or diffuse~     narrowing of the vessels especially the large vessels. Fifty percent of those patients who~     develop clinical vasospasm, progress to infarction and 15-20% will advance to disabling~     stroke or die of cerebral ischemia. The present treatment modalities are insufficient to~     prevent vasospasm. So, we need new treatment modalities to decrease the mortality and~     morbidity in SAH patients.~      The investigators hypothesize that Acetazolamide administration can prevent development of~     vasospasm after aneurysmal SAH.~   "
107092|NCT02165631|"~     The purpose of this research study is to hypothesize that Simbrinza will achieve a decrease~     in intraocular pressure and increase in ocular perfusion pressure throughout the diurnal and~     nocturnal periods. The primary aim of this study will be to determine the effects of~     Simbrinza at multiple intervals throughout a 24-hour period. The secondary aim will be to~     compare these to those of timolol.~   "
107093|NCT02165618|"~     Polypharmacy is a common problem in elderly, leading among others to increased adverse drug~     events. The aim of this pilot study was to evaluate whether a systematic medication~     evaluation by a geriatric consultation team using the RASP (Rationalisation of drugs on~     admission by an adjusted STOPP*-list in older patients) list could reduce inappropriate~     prescribing for elderly admitted patients, admitted to non-geriatric departments.~      (* = Screening Tool of Older Persons' potentially inappropriate Prescriptions)~   "
107094|NCT02165605|"~     This will be a randomized, double blind, vehicle-controlled evaluation of the effectiveness~     and safety of HylaCareTM. The study will employ the patient as her own control, a commonly~     used method for the evaluation of topical dermatologic agents. Each patient will be~     randomized blindly as to whether the study serum will be applied to the medial or lateral~     portion of the treated breast, using the nipple as the dividing line. The product and placebo~     will also be applied to the contra-lateral breast in the same fashion, as a further control.~     The study drug and placebo will be applied three (3) times daily.~   "
107095|NCT02165592|"~     Analyze and evaluate the skeletal muscle of patients affected with hemophilia in the Region~     of Murcia.~        -  Describe the periarticular muscular deficit of the lower limbs, depending on the degree~          of injury: acute and chronic, or subacute.~        -  Identify the range of motion of joints with higher prevalence of hemophilic arthropathy.~        -  Detect the biomechanical changes of the lower limbs and their impact on gait in patients~          with hemophilia.~        -  Assess the factors that influence the perception of illness and quality of life of~          patients with hemophilia.~   "
107096|NCT02165579|"~     The investigator plans a cohort study of 80 subjects admitted to hospital with a diabetic~     foot infection in order to compare serial bone biopsies (the current gold standard) and~     procalcitonin to diagnose and monitor the effectiveness of therapy for osteomyelitis. The~     investigator will collect specimens as part of an existing trial to evaluate negative~     pressure wound therapy in diabetic infected wounds. A high proportion of these patients have~     osteomyelitis and will receive standard therapy including repeat bone biopsy and parenteral~     antibiotics. The investigator expects repeated measurement of procalcitonin will be highly~     correlated with repeated bone biopsy after antibiotic treatment has been completed to~     determine if therapy has been successful or if additional antibiotic therapy is needed.~   "
107097|NCT02165566|"~     Insulin preparation -random assignment to regular insulin lin or lispro insulin as first~     treatment- was administered at constant infusion rate (0.04 units/Kg/h) in patients~     presenting blood glucose concentration ≥180 mg/dl and was discontinued when blood glucose~     concentration ≤140 mg/dl (therapeutic blood glucose concentration drop). Further reduction in~     blood glucose concentration after discontinuation of insulin infusion was recorded~     (post-infusional blood glucose concentration drop). During the study period blood glucose~     concentration, in whole blood, was measured every 30 minutes. At least 6 hours interval was~     allowed between the 2 treatments.~   "
107098|NCT02165553|"~     Hibiscus sabdariffa calyces (HSC) extract is consumed in different parts of the world as a~     cold or hot drink and is available in the United Kingdom (UK) markets in different forms~     including tea bags. There is preliminary data that support the hypothesis that HSC extract~     consumption has beneficial effect on blood vessel health and blood pressure reduction.~     Hypertension, vascular dysfunction, inflammation and lipid abnormalities are all key~     modifiable risk factors of cardiovascular diseases (CVD), the leading causes of death~     throughout the world. In the PHYTOVAS (PHYTOchemicals and VAScular Function) study the effect~     of the acute consumption a potentially bioactive food extracts: Hibiscus sabdariffa calyces~     (HSC) compared with a matched control (water) on blood pressure and blood vessels function~     will be investigated after a high - fat mixed meal. This is with a view to determining the~     impacts of the extract on postprandial (after meal) blood pressure and other CVD risk~     factors. Results from the PHYTOVAS study could lead to identification of more dietary~     approaches that will contribute to CVD risk prevention and management.~   "
107099|NCT02165540|"~     The purpose of the study is to examine the impact of doula support for women undergoing a~     manual vacuum aspiration (MVA) for an early pregnancy failure or undesired pregnancy.~   "
107100|NCT02165527|"~     The purpose of this study is to determine if Lunar iXDA scanning with the use of a computer~     software program can make accurate measurements of the length of leg bones compared to~     conventional x-rays.~   "
107101|NCT02165514|"~     Measurement of bone length in subjects diagnosed with kyphosis and scoliosis using the Lunar~     iDXA x-ray scan.~   "
107102|NCT02165501|"~     Despite the burden of severe sepsis and septic shock deficiencies in the quality of sepsis~     management are recognized. Investigators present a population-based registry with easy~     feasibility as part of German Center for Sepsis Control & Care (CSCC). All ICU patients of~     the Jena University Hospital, Germany will be screened for inclusion (severe sepsis or septic~     shock). Baseline data on ICU- and hospital care will be extracted from patient records at ICU~     discharge. The primary outcome is change in all-cause mortality from baseline to follow up at~     6, 12, 24, 36, 48 and 60 months after diagnosis of sepsis. Follow-up data will be collected~     from the primary care provider of the patient. The registry may provide valid data on quality~     in sepsis care.~   "
107103|NCT02165488|"~     30% of ketamine users complain of abdominal discomfort. Long-term ketamine use is associated~     with hepatotoxicity and pathologic changes to the biliary tract. Yet the prevalence of~     gastrointestinal and hepatobiliary pathologies in ketamine users has not been well-described.~     The investigators plan to recruit a large number of ketamine users based on referrals from~     different Psychiatry clusters in Hong Kong and to investigate the underlying cause of~     abdominal discomfort, describe the prevalence of different gastrointestinal and hepatobiliary~     pathologies and describe their long-term outcome.~   "
107104|NCT02165475|"~     Background: Biofeedback and medical treatments have been extensively used for moderate fecal~     incontinence. There is limited data comparing and combining these two treatments.~      Aim: To evaluate the effect of biofeedback and medical treatments, separately and in~     combination.~      Methods: Sixty-five consecutive female patients, referred to a tertial center for fecal~     incontinence were included. The patients were randomized to start with either biofeedback~     (4-6 months) or medical treatment with loperamide and stool-bulking agents (2 months). Both~     groups continued with a combination treatments, i.e. medical treatment was added to~     biofeedback and vice versa. A two-week prospective bowel symptom diary and anorectal~     physiology were evaluated at baseline, after single- and combination treatments.~   "
107105|NCT02165462|"~     Trial to assess the bilateral deficit phenomenon during dynamic plantar flexion task in~     patients with haemophilic arthropathy Describe the differences in terms of the physical~     variables (muscular strength, range of motion and proprioception) in patients with hemophilia~     who have conducted a home treatment with a digital tool.~      Bookmark the relationship between clinical history of joint bleeds and clinical~     manifestations in standing and walking.~   "
107106|NCT02165449|"~     The drug Ketamine, available in medical practice since the late 1960s, is currently used for~     inducing general anesthesia or sedation during medical procedures. When given slowly as an~     injection into a vein, ketamine is shown to produce a very rapid effect on depression and to~     improve depressive symptoms within hours to days. By studying patients who receive a ketamine~     IV infusion, as an add-on treatment for depression, investigators may start to understand how~     changes in the brain or in gene function relate to getting better over a very short period of~     time. In this study, the investigators will enroll 60 patients currently ill with major~     depression selected to receive IV ketamine therapy under medical supervision. To study~     neurobiological changes relating to symptom improvement, the investigators will use advanced~     brain scans to measure brain structure, chemistry and function. Blood samples will measure~     changes in gene regulation and immune system response. Although some people have a rapid~     antidepressant response to ketamine, others do not respond. Also, antidepressant effects~     after ketamine usually wear off within days to weeks. We will determine if up to four doses~     of ketamine delivered two to three times a week may prolong antidepressant response to~     ketamine therapy. To determine the durability of ketamine treatment for depression, patients~     will be monitored by phone and via electronic devices twice a week for up to five weeks and~     will return for a final assessment when their symptoms return. For this trial, brain and~     blood sample measurements will occur before and after a patient receives their first ketamine~     infusion. Patients who do not remit after an initial dose of ketamine, will receive up to~     three additional ketamine treatments. Mood will be measured 24-hours after each subsequent~     ketamine infusion and brain and blood measurements be repeated at the time of remission or~     after the fourth ketamine infusion if remission does not occur. Patients will return for a~     final brain scan and blood sample when their depressive symptoms return or at five weeks if~     they continue remission. Investigators will able to see how changes brain measurements, gene~     regulation and immune response relate to improvements and relapse of depressive symptoms with~     ketamine IV therapy. The ketamine infusion sessions will occur at a special research unit~     (CTRC) at UCLA.~   "
107107|NCT02165436|"~     The purpose of this study is to evaluate the effectiveness of chewing gum on reducing~     post-operative ileus and reducing post-operative gastrointestinal symptoms in pediatric~     patients undergoing surgical correction of scoliosis. This study would provide minimal risk~     to its study population, and has the opportunity to provide a benefit to patients undergoing~     scoliosis surgery. If shown to be effective, this could lead to changes and improvement of~     the post-operative course for pediatric scoliosis patients.~   "
108402|NCT02148536|"~     To prospectively investigate the effect of transjugular intrahepatic portosystemic shunt~     (TIPS) on oxygenation in cirrhotic patients with hepatopulmonary syndrome (HPS).~   "
107108|NCT02165423|"~     The purpose of this study is to address a gap in knowledge needed for care of children with~     solid organ transplantation (SOT) and their parents by combining mHealth technology with an~     individualized family centered self-management intervention (referred to as myFAMI). This~     study is critical to the increased understanding of hospital to home transition and family~     management at home with the potential to transform the way clinicians approach the care of~     complex chronic illness children and families.~   "
107109|NCT02165410|"~     The purpose of this study is reproduce the individual detection results by PET with Arterial~     Spin Labeling (ASL) MRI, to establish a biomarker useful in autism diagnosis.~   "
107110|NCT02165397|"~     The purpose of this study is to evaluate the safety and efficacy of Ibrutinib in combination~     with Rituximab in subjects with Waldenström's Macroglobulinemia.~   "
107111|NCT02165384|"~     The purpose of this study is to determine if the Hummingbird ear tube delivery system is a~     safe and effective way to put ear tubes in place.~   "
107112|NCT02165371|"~     It has been established that children in families affected by either intimate partner~     violence or Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS) are at~     substantially increased risk of poor parenting and child maltreatment. In the sub-Saharan~     African context of high levels of HIV/AIDS and family violence, it is crucial that parents be~     supported to establish positive parenting practices and reduce harsh or abusive parenting~     within their families.This randomized controlled trial will be testing the Sinovuyo Caring~     Families Program (n = 296), a 12-session (2.5 hour per session) parenting intervention for~     primary caregivers of children between 2 and 9 years old. Participants will not be restricted~     to biological parents and include primary caregivers of children between 2 and 9 years old,~     who live in the same house as the child at least 4 nights per week. Participants will be~     recruited through systematic household sampling, liaising with Western Cape Department of~     Social Development and local community-based NGOs. Self-reporting questionnaires and~     qualitative observational assessment data for intervention and control groups will be~     collected at pre- and post-test evaluation as well as 12-month follow-up. Primary outcomes~     will include child behaviour problems, harsh and inconsistent parenting and positive~     parenting. Secondary outcomes will include parental depression, parental stress, parental~     monitoring and supervision and parent perceived social support.~   "
107113|NCT02165358|"~     The purpose of this study is to investigate the paradoxical muscle enlargement in the calves~     and tongue seen in patients affected by Becker muscular dystrophy and Limb-girdle muscular~     dystrophy type 2I.~      The enlarged calves' muscle quality will be assessed primarily on the basis of the muscle~     structure on MRI and based on a calculation of muscle strength per cross-sectional area.The~     findings will be compared with results from non-affected controls.~      Additionally we want to describe the tongue muscle appearance on T1-weighted MRI.~   "
107114|NCT02165345|"~     This open-label extension of the JIGSAW studies (WA28117 [NCT01904279] and WA28118~     [NCT01904292]) is designed to evaluate the long-term safety and efficacy of subcutaneous (SC)~     tocilizumab treatment in participants with polyarticular-course and systemic juvenile~     idiopathic arthritis (pJIA and sJIA). Participants from the 2 JIGSAW studies will continue to~     receive 162 milligrams (mg) of SC tocilizumab with treatment schedule according to arthritis~     subtype and body weight. Participants will receive the treatment until commercial~     availability of the drug or for a maximum of 3 years, whichever is earlier.~   "
107115|NCT02165332|"~     This is a two-part study to evaluate the safety and tolerability of supratherapeutic doses of~     RO7033877 (Part 1) and to investigate the effect of RO7033877 on the QTc interval in healthy~     volunteers (Part 2). Part 1 is a single ascending dose, randomized, observer-blind,~     placebo-controlled study to determine the safety tolerability and pharmacokinetics of a~     supratherapeutic dose to be used in Part 2. Participants will be randomized in up to 8~     cohorts to receive a single dose of either RO7033877 or placebo. Part 2 will be a single~     dose, randomized, double-blind, double dummy, placebo-controlled, positive control, 4-way~     crossover study. Part 2 will evaluate whether a single therapeutic or supratherapeutic dose~     of RO7033877 has a threshold pharmacologic effect on cardiac repolarization, as detected by~     changes in the QT/QTc interval measured by electrocardiogram (ECG). Pharmacokinetic~     parameters will be assessed for Parts 1 and 2, continuous ECG recordings will be evaluated in~     Part 2.~   "
107116|NCT02165319|"~     To compare the cuff pressure in lateral position between barrel-shaped cuff and taper-shaped~     cuff~   "
107117|NCT02165306|"~     More than half of patients with epilepsy achieve full control of their seizures with~     antiepileptic drugs (AEDs).The study is aimed to investigate effectiveness of an educational~     intervention in improving medication adherence in patients with epilepsy.~   "
107118|NCT02165293|"~     This single-center, open-label study will investigate RO7033877 concentrations in plasma and~     in various lung compartments, including epithelial lining fluid (ELF), and alveolar~     macrophages (AM) in healthy volunteers after multiple intravenous (IV) administration.~     Bronchoscopy will be performed after the start of the last infusion on Day 3 at different~     timepoints. Blood, urine and brochoalveolar lavage samples will be collected to determine~     RO7033877 concentrations. The anticipated time on study treatment is 3 days.~   "
107119|NCT02165280|"~     We hypothesize that women who use GIM pre-operatively will feel more prepared for surgery,~     have less anxiety on the day of surgery and have higher satisfaction scores 6 weeks after~     surgery compared to women who undergo our routine pre-operative care.~   "
107120|NCT02165267|"~     Antibodies are natural proteins that the body makes to fight infections. Antibodies can also~     be manufactured like a drug and infused or injected into the body to prevent or treat a~     disease. The purpose of this study is to test the safety of and the body's response to an~     antibody against HIV in healthy, HIV-uninfected adults.~   "
107121|NCT02165254|"~     The purpose of this study is to develop a tai-chi based exercise program designed for~     patients who recently had a heart attack and do not wish, or are unable, to attend~     traditional cardiac rehabilitation.~   "
107253|NCT02163538|"~     This is an exploratory study to assess the ability of the raw-TLX (raw Task Load Index)~     ergonomic assessment tool to detect differences in surgeon workload when using commercially~     available advanced bipolar devices. It is anticipated that the raw-TLX version of the~     validated NASA-TLX ergonomic assessment tool will detect less surgeon effort required in the~     procedure when articulating ENSEAL is utilized. The Articulating ENSEAL device may also~     positively impact other variables such as blood loss, operative time and cost.~   "
107122|NCT02165241|"~     It is commonly known that heart failure (HF) is the main cause of mortality and morbidity~     which affects about 15 million people in the world and is the primary chronic cause of death.~     In spite of the development of pharmacological therapies which have led to a good control of~     the pathology, almost 50% of patients with advanced HF does not survive after the first year.~     Heart failure consists of a deterioration of the cardiac pump, whose performance become~     insufficient to satisfy the organism needs. HF can be the consequence of various pathologies,~     such as ischemia, chronic hypertension, valvulopathies, pericarditis, etc. In conditions of~     chronic overload, as the one induced by the cited pathologies, the cardiomyocytes reply with~     hypertrophy and/or death due to necrosis or apoptosis. At the same time, there is a collagen~     alteration which causes the substitution of the myocardial damaged portion with fibrotic~     material, increasing in this way cardiac rigidity and reducing contractility. Finally, the~     onset of inflammation, the activation of the immune system and of the inflammatory mediators~     affect heart functionality. These phenomena are regulated by a complex interaction between~     the cellular and molecular mechanisms, which moreover guarantee the homeostasis maintenance~     in physiological conditions. Nevertheless, their imbalance activates a complex series of~     events which have recently started to be recognized and studied. In effect, a recent work has~     underlined the importance of the splenic monocytes in the cardiac response to acute heart~     ischemia, changing our vision concerning the role of the immune system in heart~     diseases.Historically, the term cardiac remodeling had been introduced to describe the~     anatomical change of the heart which occurs after myocardial infarction. At a later stage, it~     has been acknowledged that also other pathological conditions, such as chronic hypertension,~     can be a cause of the myocardial remodeling. Physiologically, the immune system cells have~     always been considered for their role of protection from infections. Recently, instead,~     evidence have been showing that immune system cells might have far more complex functions in~     the heart. The myocardial remodeling comes from modifications that may be adaptive to the~     initial insult, but then this structural adjustment may become the activation of~     structural/metabolic circles which can potentially culminate in the transition to HF.~      This observational study will evaluate the immunological profile in relation to cardiac~     geometry variations in hypertensive patients. Aim of this project is to characterize the~     profile of immune system activation during the process of cardiac remodeling which is typical~     of the cardiomyopathy of overload. The main goal will be reached through the characterization~     of the circulating profile of immune system cells, in order to find a correlation with the~     clinical phenotype.~   "
107123|NCT02165228|"~     The long-term goal of the proposed research is to identify and develop effective~     interventions to decrease persistent, low-level inflammation and risk of CVD. Stress is a~     substantial contributor to inflammation, and interactions among stress, inflammation, body~     mass index, and health behaviors have been measured. Mindfulness-based stress reduction~     (MBSR) is effective for stress reduction, has been shown to be effective for inflammation~     reduction in individuals with disease, and is a sustainable practice for individuals across~     the health spectrum. Diet strategies are an effective means of reducing inflammation for some~     individuals, but may not be successful for many people, as evidenced by the steady rise in~     obesity rates. The specific aims of this study are to 1) test the effectiveness of MBSR~     compared to an established intervention of a nutrition enhancement (NE) intervention for the~     reduction of inflammation, and 2) test the effectiveness of MBSR compared to a~     non-intervention control conditions (CON) for the reduction of inflammation. Men and women~     25-45 years of age will be randomly assigned to participate in MBSR (n=60) or DIET (n=60) or~     CON (n=60) interventions for 16 weeks. Serum CRP concentrations, additional inflammatory~     cytokines (tumor necrosis factor-a, interleukin-6), cortisol diurnal profiles,~     anthropometrics, dietary intake, and all components of the metabolic syndrome will be~     measured pre- and post-intervention to elucidate underlying mechanisms and to determine~     whether health benefits beyond inflammation reduction occur.~   "
107124|NCT02165215|"~     This Phase III, randomized, double-blind, parallel-grouped, placebo-controlled, multicenter~     study will investigate the efficacy and safety of etrolizumab in maintenance of remission in~     participants with moderately to severely active UC who are naive to TNF inhibitors and~     refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment.~   "
107125|NCT02165202|"~     This is a multi-site, double-blinded, two-arm, two:one, randomized, trial comparing the~     safety of an intramuscular (IM) injection of TMC278 LA to a placebo given once every eight~     weeks over a 40 week period among sexually active, HIV- uninfected women.~   "
107126|NCT02165189|"~     The purpose of this study is to evaluate sustained virologic response 12 weeks after the end~     of treatment (SVR12) following 12 weeks of simeprevir plus sofosbuvir with and without~     ribavirin (RBV) and 24 weeks of simeprevir plus sofosbuvir without RBV in post orthotopic~     liver transplant participants with recurrent hepatitis (inflammation of the liver) C virus~     (HCV) Genotype 1 infection.~   "
107127|NCT02165176|"~     Few studies have been conducted to assess the pharmacokinetic and pharmacodynamic effects of~     orally consumed intact cannabis (e.g., cannabis-containing brownies). Careful analysis of~     oral cannabis dose effects on these parameters is required to determine the level and~     duration of biological cannabinoid exposure and associated subjective, cardiovascular and~     cognitive effects. The present study will evaluate the detection of cannabinoids in oral~     fluid, plasma, hair, and urine for up to 9 days following consumption of oral cannabis (10mg,~     25mg, or 50mg THC). In addition, we will conduct subjective, behavioral, and cognitive~     performance assessments to evaluate the time course of the consequences of oral cannabis~     ingestion among study participants. The outcomes of the study will extend scientific~     knowledge about the behavioral pharmacology and toxicology of oral cannabis and can inform~     policies regarding clinical, workplace and roadside drug testing programs.~   "
107128|NCT02165163|"~     The aim of the present study is to evaluate an innovative virtual reality-based balance~     training intervention for improving clinically relevant motor performances (balance and gait)~     in cancer patients.~      The investigators hypothesize that the virtual reality-based balance training intervention~     will improve balance and gait performances in cancer patients compared to a control group~     receiving usual care only.~   "
107129|NCT02165150|"~     The goals of this research project are: 1) to develop and evaluate the safety and feasibility~     of the Senior Elastic Band (SEB) exercise program for elderly residents in long term care~     facilities, 2) to evaluate the long-term effects of the SEB on physical functional fitness~     and sleep quality of elderly residents in long term care facilities, and 3) to investigate~     the compliance of elderly residents with long-term SEB exercises.~   "
107130|NCT02165137|"~     Quality control and improvement project: Assessment and analysis of processes and outcome in~     trauma emergency room and major trauma patients at the Aarau trauma center (cantonal~     hospital) with regard to initial emergency management, hospital processes and short- and~     long-term (1-and 2-year) outcome of patients (subjective and objective). Comparison of~     processes and outcome pre- and post- project initiative. Benchmarking with the literature and~     by participation in the German and Swiss Trauma registry each.~   "
107554|NCT02159599|"~     This is an open label randomized clinial trial to evaluate the treatment with~     darunavir/ritonavir (800mg/100mg) plus lamivudine (300 mg) once daily versus continuing with~     darunavir/ritonavir (800mg/100mg) once daily plus tenofovir/emtricitabine (300mg/200mg) or~     abacavir/lamivudine (600mg/300mg) in HIV infected subject with suppressed plasma viremia.~   "
107131|NCT02165124|"~     The purpose of this study is evaluate the safety and effectiveness of bariatric embolization~     as a minimally-invasive image-guided procedure for morbid obesity. In this procedure,~     specific blood vessels to the stomach are blocked in order to suppress some of the body's~     signals for feeling hungry, leading to weight loss.~      Morbid obesity is currently treated with diet and exercise, medications, and surgery. This~     study is designed to help treat obesity using a minimally invasive, non-surgical,~     angiographic (through the blood vessel) approach. This procedure is similar to a common~     procedure used to treat bleeding within the stomach. This version of the procedure has been~     named bariatric embolization.~      Although there are over 40 hormones that limit food intake, there is only one hormone,~     ghrelin that has been shown to stimulate (prompt) food intake. In obese patients, eating~     fails to suppress ghrelin levels, which is believed to prevent feeling full after a meal and~     to lead to overeating. Due to the strong hunger craving effects of ghrelin, this hormone has~     been a target for the treatment of obesity and weight loss. More recently, ghrelin has been~     shown to have a significant role in the long-term effect of weight loss in bariatric~     (obesity) surgery where ghrelin levels are shown to be much lower when compared to untreated~     patients.~      Recent data collected in animals in has shown that blocking blood vessels to a particular~     portion of the stomach (bariatric embolization) can temporarily decrease levels of the~     appetite inducing hormone ghrelin, and decrease short-term weight gain. In a study of 5~     people, there was a decrease in ghrelin levels and weight loss in the first month after the~     procedure, but there is no information about the effects of the procedure over longer periods~     of time.~      The investigator hopes to learn if bariatric embolization results in safe and effective~     weight loss in people who are morbidly obese.~   "
107132|NCT02165111|"~     This is a randomized, double-blinded, clinical trial assessing the therapeutic efficacy of~     Botulinum toxin A (Onabotulinumtoxin A) in treating scleroderma-associated Raynaud's~     syndrome. Each patient will undergo injection with a treatment dose of Botulinum toxin A in~     one randomly-selected hand, and the contralateral hand will be injected with sterile saline~     (placebo) to serve as a control.~      Study participants at the first study visit will complete study questionnaires, their hands~     will be assessed clinically for digital ulceration, and their hands will undergo non-invasive~     laser Doppler imaging to assess blood flow. After this initial assessment, the patients will~     undergo peri-arterial injection of Botulinum toxin A in one hand, and of sterile saline~     solution (placebo) in the other, in a randomized, blinded manner.~      Patient will report the severity of their Raynaud's symptoms weekly over the four month study~     period. At one month post-injection, the patient will complete study questionnaires, their~     hands will be assessed clinically for digital ulceration, and their hands will undergo~     non-invasive laser Doppler imaging. At four months post-injection, the patient will again~     complete study questionnaires, their hands will be assessed clinically for digital~     ulceration, and their hands will undergo non-invasive laser Doppler imaging. In addition,~     patient will be given the option of one week post-injection visit, at which point the same~     assessment will be performed.~      At the conclusion of the study, unblinding will occur.~   "
107133|NCT02165098|"~     The investigators are doing this study to compare blood levels and side effects of~     cariprazine when it's taken as one of two 'slow release' tablets, or as an 'immediate~     release' capsule. The investigators will also find out if food affects the absorption of~     cariprazine into the bloodstream after a 'slow release' tablet.~   "
107134|NCT02165085|"~     The purpose of this study is to determine whether patients with vascular Ehlers-Danlos~     syndrome present significant and specific changes of arterial endothelial and smooth muscular~     cell signalling/secretion, in comparison to matched healthy volunteers and patients with~     spontaneous arterial dissections.~   "
107135|NCT02165072|"~     This is an observational study that will examine the possibility of determining the type of~     Acute Kidney Injury (AKI) using bedside ultrasound machines.~   "
107136|NCT02165059|"~     In this research study, biopsy samples will be collected to provide more insight into the~     underlying cause of the motility disorders, help direct further investigation into the cause~     of the underlying condition, provide future prognosis and predict response to gastric~     electrical stimulation (GES).~   "
107137|NCT02165046|"~     Budesonide + Procaterol HFA MDI is a novel asthma product containing both budesonide and~     procaterol in a single inhaler. Budesonide is a corticosteroid that treats underlying airway~     inflammation in asthma. Procaterol is a direct acting sympathomimetic with predominantly~     Beta-adrenoceptor stimulant activity selective to Beta-2 receptors (a Beta-2 agonist). It is~     used as a bronchodilator in the management of reversible airways obstructive pulmonary~     disease. Budesonide and Procaterol therefore have complementary effects, treating two~     different components of asthma.~   "
107138|NCT02165033|"~     Budesonide + Procaterol HFA MDI is a novel asthma product containing both budesonide and~     procaterol in a single inhaler. Budesonide is a corticosteroid that treats underlying airway~     inflammation in asthma. Procaterol is a direct acting sympathomimetic with predominantly~     Beta-adrenoceptor stimulant activity selective to Beta-2 receptors (a Beta-2 agonist). It is~     used as a bronchodilator in the management of reversible airways obstructive pulmonary~     disease. Budesonide and Procaterol therefore have complementary effects, treating two~     different components of asthma.~   "
107139|NCT02165020|"~     The present Phase II study aims to assess the rates of late rectal toxicities of grade ≥ 2~     after hypofractionated radiotherapy of prostate cancer of 62 Gy in 20 fractions of 3.1 Gy~     with an injection of hyaluronic acid (HA) in the space between the rectum and the prostate.~     Thirty-six patients with a low- to intermediate-risk prostate cancer according to the D'Amico~     classification are included in the present protocol. The main characteristics of the study~     are that the patients benefit of a reduction of the treatment duration from 40 to 20~     fractions, due to the hypofractionated irradiation, and of an injection of 3 to 10 cc of~     hyaluronic acid in the perirectal fat between the rectum and the prostate.~   "
107140|NCT02165007|"~     The study is designed as a Pilot/Phase 1 trial of reduced intensity Haploidentical HSCT in~     patients with sickle cell disease and thalassemia. The purpose of the study is to assess the~     safety and toxicity of reduced intensity conditioning haploidentical hematopoietic stem cell~     transplantation.~   "
107141|NCT02164994|"~     This clinical study is an open, controlled, prospective, single center, single-surgeon,~     post-market-clinical-follow-up study to evaluate the long-term (18 months) effectiveness of~     the femtolaser-assisted astigmatic keratotomy.~   "
107142|NCT02164981|"~     The primary objective of this study is to investigate whether a single infusion of~     intravenous sodium nitroprusside (0.5 μg/kg/min for 4 hours) is superior to placebo (5%~     dextrose solution) at in treating positive and negative symptoms of schizophrenia~   "
107254|NCT02163525|"~     This Post Market study is being conducted to compare the direct and indirect cost of three~     approaches (GFA, myomectomy, and uterine artery embolization) for the treatment of~     symptomatic uterine fibroids. In addition, data from this study is being used to satisfy the~     requirements of the United States Food and Drug Administration's 522 (post market~     surveillance) order.~   "
107143|NCT02164968|"~     INTRODUCTION~      Lung function assessment of preschool children is hindered by their limited co-operation in~     conventional tests such as peak expiratory flow (PEF) or spirometry and the methods available~     for younger children are, again, laborious and time consuming. However, impedance~     pneumography (IP) records indices of airway obstruction during normal sleep at home and has~     been shown accurate in wheezy preschool children (Seppä et al. J Appl Physiol 2013).~      AIM OF THE STUDY~      The general purpose of this study is to assess the clinical value of the information provided~     by overnight home recording of tidal breathing by means of IP technique in young children~     with asthmatic symptoms and inhaled corticosteroid (ICS) medication.~      The main hypothesis is that IP measurement can distinguish between groups whose asthmatic~     symptoms recur or do not recur after ending the ICS drug treatment period.~      METHODS~      The study recruits 1-5 year old children (n=75) who have presented at the emergency room due~     to obstructive bronchitis and for whom an ICS drug treatment period has been prescribed based~     on the national guidelines.~      The subjects will perform three overnight IP measurements at home at two weeks intervals~     close to and after ending of the treatment period.~      SIGNIFICANCE OF THE STUDY~      Being an affordable, simple and convenient ambulatory measurement method, IP may bring needed~     objectivity to asthma diagnostics and asthma drug response assessment in young children.~   "
107144|NCT02164955|"~     This registry is a prospective, multi-center, observational study and will collect safety~     data on multiple myeloma adult patients who have received at least two prior therapies and~     take IMNOVID (pomalidomide) as part of standard care.~      The registry will remain open until 500 patients will have received at least 3 cycles of~     pomalidomide. All patients registered will be followed up prospectively for up to 3 years~     following the end of pomalidomide treatment. During this time the incidence of second primary~     malignancies (SPM), overall survival and any occurrence of a pregnancy will be assessed.~   "
107145|NCT02164942|"~     This is a prospective, single arm, observational study examining aurora kinases and~     circulating tumor cells in subjects with bladder cancer being treated with standard~     cisplatin-based chemotherapy.~   "
107146|NCT02164929|"~     The purpose of this study is to assess the effectiveness of transversus abdominal plane (TAP)~     block, thoracic epidural or paravertebral block (PVB) for controlling postoperative pain when~     compared with opioid you self-administer in your vein using a PCA device. The primary outcome~     will be postoperative opioid consumption within 24 hours after surgery. A total of 120~     subjects will be randomized in a 1:1:1:1 ratio to receive a TAP block, PVB, TEA or no block~     (PCA alone).Patients in all groups will be cared for using an established enhanced recovery~     after surgery (ERAS) pathway incorporating a multimodal analgesic regimen using IV~     acetaminophen and postoperative PCA fentanyl.~   "
107147|NCT02164916|"~     This randomized phase II trial studies how well irinotecan hydrochloride and cetuximab with~     or without vemurafenib works in treating patients with colorectal cancer that has spread to~     nearby tissue or lymph nodes, that has spread to other places in the body, or cannot be~     removed by surgery. Irinotecan hydrochloride and vemurafenib may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as~     cetuximab, may block the ability of tumor cells to grow and spread. It is not yet known~     whether irinotecan hydrochloride and cetuximab are more effective with or without vemurafenib~     in treating colorectal cancer.~   "
107148|NCT02164903|"~     The broad goal of this study is to investigate if differences exist (and in which areas and~     of what magnitude) in QoL and symptoms of patients with CML being treated with first line~     therapy with dasatinib versus those receiving first line therapy with imatinib. Also, an~     additional objective is to characterize medication-taking behavior associated with imatinib~     or dasatinib.~   "
107149|NCT02164890|"~     Invasive fungal infections (IFIs) are a frequent cause of morbidity and mortality in~     high-risk patients, such as immunocompromised patients. Candida is currently the predominant~     fungal pathogen in these patient populations and is associated with significant morbidity and~     a high mortality.~      Micafungin (MCF) is a semisynthetic compound belonging to the new class of antifungal agents,~     the echinocandin lipopeptides, that has potent in vitro and experimental in vivo activity~     against a variety of pathogenic Candida species and Aspergillus species. Its applied~     indications are so the treatment and/or the prophylaxis of Candida and Aspergillus~     infections. MCF is currently licensed for the treatment of candidiasis at doses of either 100~     or 150 mg a day.~      The efficacy of MCF is linked to the area under the concentration-time curve over 24 h in the~     steady state divided by the MIC (AUC0-24/ MIC ratio).~      On one hand:~      - It was demonstrated that 98% of invasive candidiasis patients with a MCF AUC/MIC ratio~     between 3 and 12 achieve microbiological clearance, as opposed to only 85% of those with an~     AUC/MIC ratio < 3. In the case of infections by Candida parapsilosis, which exhibits drug~     MICs that are 50- to100-fold higher, 100% of patients with an AUC/MIC ratio >285 achieve~     microbiological clearance, as opposed to 82% of those below that exposure level.(1)~      On the other hand:~        -  It is well known that patients of intensive care units (ICU) are characterized by~          particular pharmacokinetic parameters with higher apparent volume of distribution (VC/F)~          and/or higher apparent systemic clearance (CL/F). In a population of healthy volunteers,~          it was observed that CL/F of MCF presents a high interpatient variability.(2)~        -  Whether most ICUs patients achieve optimal AUC/MIC ratio thresholds at standard doses~          has not been investigated so far. In particular, lower AUCs might be reached in patients~          having the highest VC/F values. Such patients would then be at risk of therapy failure~          and would benefit from individualized-dosing strategies.~      In this context, the study of the pharmacokinetics of MCF in critically ill patients seems to~     be necessary.~   "
107150|NCT02164877|"~     The purpose of this study is to evaluate the effect of soluble dietary fiber on bacterial~     translocation and mucosal immunology in patients with Crohn's disease.~   "
107151|NCT02164864|"~     The main objective of this study is to compare a Dual Antithrombotic Therapy (DAT) regimen of~     110mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (110mg DE DAT) and 150mg~     dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (150mg DE-DAT) with a Triple~     Antithrombotic Therapy (TAT) combination of warfarin plus clopidogrel or ticagrelor plus ASA~     <= 100mg once daily (warfarin-TAT) in patients with Atrial Fibrillation that undergo a PCI~     with stenting (elective or due to an Acute Coronary Syndrome).~      The study aims to show non-inferiority of each dose of DE-DAT when compared to Warfarin-TAT~     in terms of safety. Safety will be determined by comparing the rates of bleeding events,~     assessed using the modified International Society of Thrombosis and Haemostasis~     classification of Major Bleeding and Clinically Relevant Non Major Bleeding Events.~   "
107152|NCT02164851|"~     The goal of this study is to compare the characteristics of echocardiography and different~     monitoring devices in shock patients, the relationship of device parameters to biomarkers~     associated with shock, and determine if these any of these add clinical utility when~     predicting the cause of shock. We will perform a prospective, observational study of patients~     found to have shock physiology in the ED and follow them to determine the final shock~     category and ultimate outcomes.~   "
107153|NCT02164838|"~     This trial will be the first study of axitinib in children and adolescents. The primary~     objective of this Phase 1 trial is to determine a maximum tolerated dose (MTD) or recommended~     Phase 2 dose (RP2D) of axitinib in pediatric patients with refractory solid tumors.~     Additional objectives include measurement of pharmacokinetic and pharmacodynamic parameters,~     description of the toxicity profile of this agent in children and adolescents, and assessment~     of response within the confines of a Phase 1 trial. A standard rolling 6 design will be used~     for dose escalation. Further development of axitinib will focus on development of a joint~     cooperative group (COG/ECOG) Phase 2 study of axitinib in pediatric, adolescent and young~     adult translocation renal cell carcinoma.~   "
107154|NCT02164825|"~     Single-shot femoral nerve block is similar to continuous epidural technique for postoperative~     analgesia in total knee arthroplasty~   "
107155|NCT02164812|"~     The purpose of this study is to determine whether multiple doses of Efavirenz has an effect~     on the QTc interval (corrected by Fridericia) in CYP2B6 *1/*6 and *6/*6 healthy subjects.~   "
107156|NCT02164799|"~     The Shock Tool study is designed to improve the clinical evaluation for differentiating shock~     in the emergency department. The goal of this study is to evaluate and improve the accuracy~     of physicians differentiating causes of shock.~   "
107157|NCT02164786|"~     Acute severe disease is a major public health challenge that often affects young adults.In~     past decade, there are lot of new techniques have been developed that aim to improve the~     outcome of acute severe disease, But few of these works success. According to recently~     studies, the mortality of the multiple organ dysfunction syndrome（MODS) that is the major~     cause of death in patients who suffering from acute severe disease, is not improved. On the~     contrary, if MODS be predicted in early stage of acute severe disease, the death can be~     prevented. Because acute severe disease poses complex injury that involves multiple~     pathological processes, understanding the cellular and metabolic network malfunction during~     acute severe disease is crucial for clinical monitoring and intervention.~      Human metabolism is a complex network with hundreds of cross-linked paths. During critical~     illness, the metabolic network is dynamically disturbed at multiple points. Classical~     research typically isolates a small part of this network to investigate the impact of~     pathological physiology molecular mechanisms on clinical outcome. In particular, researchers~     have examined metabolic disturbances such as cytokine network dysfunction, skeletal muscle~     breakdown, insulin resistance, dyslipidemia, testosterone and growth hormone/Insulin like~     growth factor （IGF）dysfunctions, low thyroxine syndrome, and deficiency of vitamin D and~     calcium with secondary hyperparathyroidism. These complex metabolic disturbances appear and~     interact at different stages during the pathological process after acute severe illness.~     Therefore, an integrated approach that combines the biochemical/molecular changes with~     network disturbances is the key to understanding acute severe illness at the systems biology~     level and establishing an accurate quantitative model for clinical monitoring.~      An interdisciplinary method that includes high-throughput quantitative techniques and~     effective mathematical and visualization tools is necessary. Furthermore, interdisciplinary~     methods present the opportunity to develop innovative clinical diagnosis and monitoring~     methods for severe injuries. The aim of this study is to provide a novel high-throughput~     method that integrated proton-nuclear magnetic resonance (NMR) metabolomic fingerprinting and~     High Performance Liquid Chromatography with advance mathematics tools to modeling metabolic~     dynamics after acute severe disease.~   "
107158|NCT02164773|"~     Emergence agitation after sevoflurane anesthesia is still a problem needed to be solved.The~     aim of the study is to delineate the effect of caudal magnesium sulfate in children~     undergoing lower abdominal surgery to prevent postoperative emergence agitation.~   "
107159|NCT02164760|"~     In this study the safety and feasibility of an acellular dermal template (Novomaix), combined~     with split thickness skin grafts, for use in patients with full thickness skin defects, is~     tested. Results will be compared intra-patient with those obtained after conventional~     treatment with split thickness skin grafts. We expect this treatment to be safe, and to~     provide better outcome regarding scar quality.~   "
107160|NCT02164747|"~     The purpose of this study is to determine whether teleconsulting would be effective and~     cost-effective by reducing the patients transportations and the use of emergency units for~     nursing home residents.~   "
107161|NCT02164734|"~     In this study, newborn babies with respiratory distress syndrome (RDS), receiving oxygen via~     nasal continuous airway pressure (CPAP) modalities, and needing surfactant treatment will be~     randomized to standard delivery of surfactant via and endotracheal tube airway (inserted~     after pre-medication for pain with a short-acting narcotic), or to surfactant delivery via~     laryngeal mask airway (LMA). The intent is to remove the airways and return babies to~     non-invasive CPAP support, after surfactant is given. The primary outcome measure is the rate~     of failure of initial surfactant therapy. Standardized failure criteria are reached: a)~     early, if the baby is unable to be placed back on non-invasive CPAP (i.e., needs tracheal~     intubation and mechanical ventilation) or, b) late, if the baby requires ventilation,~     retreatment with surfactant within 8 hours or more than 2 doses of surfactant.~      The objective of this protocol is to reduce the need for endotracheal intubation and~     mechanical ventilation in preterm neonates with RDS needing rescue surfactant therapy by~     instilling surfactant though an LMA, while achieving comparable efficacy of surfactant~     treatment.~      The hypothesis is that surfactant treatment through an LMA will decrease the proportion of~     babies with RDS who require mechanical ventilation or subsequent intubation, when compared to~     standard surfactant treatment following endotracheal intubation with sedation.~   "
107162|NCT02164721|"~     The purpose of this trial or study is to determine if cardiac resynchronization therapy (CRT)~     can be a benefit to people who have impaired heart function due to past treatment with~     chemotherapy and/or chest radiation. The investigators are looking to enroll approximately 30~     eligible subjects with heart failure in this trial. All patients enrolled and registered in~     the study will be implanted with a cardiac resynchronization therapy device that includes an~     implantable cardiac defibrillator (CRT-D). Clinical histories, physical exams, and external~     device testing will be collected both at the time of enrollment in the trial and during~     follow-up study visits. Following implantation of the CRT-D, patients will be contacted by~     phone at 3 months and will have a scheduled clinic visit follow-up at 6 months.~   "
107177|NCT02164526|"~     Left heart disease is the main cause of pulmonary hypertension. With the advent of the aging~     society, chronic heart failure has become a global public health problem. Therefore the~     prevalence of pulmonary hypertension due to the left heart disease is increasing. However,~     there is no research on the prevalence of pulmonary hypertension due to the left heart~     disease in China. Therefore, the aim of the present study was to describe real-world outcome~     of Chinese patients with pulmonary hypertension due to the left heart disease and identify~     factors that may predict outcome. Our study will profile the demographics, clinical course,~     treatments, and outcomes of pulmonary hypertension due to the left heart disease in China.~   "
107255|NCT02163512|"~     Multicentric, observational and prospective study with two groups of treatment: Refractory~     ascites and non-refractory ascites. All patients should be prescribed beta-adrenergic~     blockers as primary or secondary profilaxis for variceal bleeding.~   "
107163|NCT02164708|"~     This paper extends prior research by exploring how students with self-critical (SC) traits~     respond to mindfulness meditation (MM) with a twofold purpose: i) to study anxiety~     sensitivity and mood changes during the school year as students attended MM tutorials ii) to~     study the relationship between self-criticism and MM-related benefits over time. This paper~     reports on participants' mood and anxiety sensitivity changes before, during, and after the~     MM program and the association between depressed mood and SC levels. Participants were~     trained in MM over two continuous semesters, with two specific hypotheses guiding~     evaluations:~        1. Participants overall would report progressive improvements in psychological well-being~          as measured by mood and anxiety sensitivity variables, reflecting the effectiveness of~          the MM program.~        2. Elevations in self-critical personality traits would predict greater improvements in~          depressed mood, given the greater need to neutralize cognitive events related to~          negative moods.~   "
107164|NCT02164695|"~     To evaluate whether remote ischemic per-conditioning (RIPC) can reduce infarct size in~     patients with ST-segment elevation myocardial infarction treated with primary percutaneous~     coronary intervention (PPCI) within 12 hours of symptoms onset.~        -  Control group: PPCI only~        -  Study group: PPCI + RIPC~      Primary endpoint: Infarct size measured by contrast-enhanced cardiac magnetic resonance (CMR)~     at 6 months after the index procedure~   "
107165|NCT02164682|"~     Hypospadias refers to a disease represented by a congenital defect in the urethra meatus~     (urinary opening) in male children. Due to the postoperative pain, symptoms such as~     discomfort, agitation, and restlessness are generally found. In particular, young children~     with restlessness often express their pain or discomfort with their bodies because they are~     unable to express it in words. This severe restlessness may make an operated region unstable,~     accompanying bleeding, infection, or other surgery-related complications. Because~     postoperative pain control is very important, neuraxial block techniques such as epidural~     block or caudal block have been employed in addition to a penile dorsal nerve block. Although~     the neuraxial block technique including the caudal block is an easy and safe method and has~     an excellent effect, the neuraxial block technique poses a potential risk in the procedure.~     In addition, with respect to the surgical prognosis, it has been reported that penile~     engorgement may cause penile vasodilation, resulting in oozing at the surgical region or~     other surgical complications. However, there has not been a report on the increase of~     postoperative complications by penile vasodilation or on the difference in the recovery or~     surgical prognosis according to the types of pain control for young patients.~   "
107166|NCT02164669|"~     Postoperative cognitive dysfunction (POCD) may lead to serious consequences. But the~     underlying mechanisms are still unclear. Blood Oxygen Level Dependent (BOLD) fMRI and~     biochemical indicators will be used to explore the underlying mechanisms and represent a~     promising precursory target for diagnosis and treatment of POCD.~   "
107167|NCT02164656|"~     The Mindfulness Training for Smokers Online Feasibility Study is a pilot study designed to~     test Mindfulness Training for Smokers in an Internet format with phone counseling.~   "
107168|NCT02164643|"~     A Multicenter national longitudinal cohort study including at least 800 individuals~     consecutively recruited from French Research Memory Centers and followed-up over 24 month and~     included in Memento.~   "
107169|NCT02164630|"~     The purpose of this study is to examine the effects of a hope-based intervention on clinical~     and experimental pain in individuals with temporomandibular disorder (TMD). To examine the~     effectiveness of this intervention, a two-arm randomized trial will be conducted with 50~     individuals, between the ages of 18 and 65, who have TMD.~   "
107170|NCT02164617|"~     The goals of this three-year research project were: 1) to develop and evaluate the~     feasibility of the Wheelchair-bound Senior Elastic Band (WSEB) for the demented,~     wheelchair-bound seniors in long-term care facilities, 2) to evaluate the long-term effects~     of the instructor-led WSEB on the functional fitness, daily life function, depression, and~     problem behaviors of this senior population, and 3) to test the feasibility, compliance, and~     effectiveness of the DVD-led WSEB on this senior population.~   "
107171|NCT02164604|"~     Retinopathy of prematurity (ROP) is a neovascular retinal disorder of premature born~     children, characterized by the development of retinal neovascularisation, macular dragging~     and eventually retinal detachment. ROP is a leading cause for childhood blindness, especially~     in developing countries. Vascular endothelial growth factor (VEGF) plays an important role in~     the development of the disease. Recently, the BEAT ROP study tested the efficacy of~     intravitreal bevacizumab for stage 3 plus ROP in a prospective, controlled, randomized,~     stratified, multicenter trial. Authors found that bevacizumab showed a significant benefit~     for Zone I but not Zone II disease, with continuation of peripheral retinal vessel growths~     after treatment. The authors also concluded that safety could not be assessed due to the~     small sample size. Other authors raised concerns regarding the results of the BEAT ROP study~     and the safety of bevacizumab.~      The investigators suspected a better safety profile for ranibizumab to treat stage 3 plus~     ROP. Here we present the outcome of 6 eyes with ROP stage 3 plus treated with a single~     injection of ranibizumab.~   "
107172|NCT02164591|"~     The purpose of this study is to determine the physiologic effects of temporary gastric~     electrical stimulation in subjects with severe gastroparesis.~   "
107173|NCT02164578|"~     Study to investigate microvascular and antiinflammatory effects of Rivaroxaban compared to~     low dose aspirin in type 2 diabetic patients.~      Especially patients with cardiovascular disease and subclinical inflammation are in the focus~     of interest.~   "
107174|NCT02164565|"~     The use of Tranexamic Acid (TXA) intravenously, to Reduce Blood Loss in proximal femur~     surgery.~   "
107175|NCT02164552|"~     The study tests the hypothesis that correction of vitamin D deficiency among women with PCOS~     will improve insulin sensitivity and resistance and inflammatory response to PCOS.~   "
107176|NCT02164539|"~     The purpose of this study is to evaluate the dose-response of 4 doses of umeclidinium bromide~     in combination with fluticasone furoate compared with fluticasone furoate monotherapy in~     chronic obstructive pulmonary disease participants with an asthmatic component. The~     fluticasone furoate/umeclidinium bromide treatments will also be compared to the once-daily~     inhaled corticosteroid/long-acting beta agonist combination fluticasone furoate/vilanterol.~   "
107555|NCT02159586|"~     The objective of this study is to determine if Gastric Electrical Stimulation may influence~     vagal outflow via vagal afferent fibers that terminate in the Central Nervous System.~   "
107178|NCT02164513|"~     The study evaluates the efficacy of fluticasone furoate/umeclidinium bromide/vilanterol~     (FF/UMEC/VI) to reduce the annual rate of moderate and severe exacerbations compared with~     dual therapy of FF/VI or UMEC/VI in subjects with COPD. Published studies which assessed the~     use of an 'open' triple therapy (use of Inhaled Corticosteroid [ICS]/ Long-acting Muscarinic~     Receptor Antagonists [LAMA])/ Long Acting Beta-Agonist [LABA] delivered via multiple~     inhalers) in moderate-severe COPD patients, reported improvements in lung function, Health~     Related Quality of Life (HRQoL), hospitalization rates and rescue medication use, compared to~     dual therapy (ICS/LABA) or LAMA alone. These studies have also shown similar safety profile~     with dual or monotherapy doses for periods of up to one year. Given the clinical experience~     with FF, UMEC and VI, and that the associated risks with these compounds are anticipated from~     their known pharmacology, the potential benefit of a new therapy option in patients with~     moderate to severe COPD supports the further development of the closed triple combination~     (delivered via one inhaler). In the current study subjects meeting all inclusion/exclusion~     criteria will complete 2-week run-in period; 52 week treatment period and a 1-week safety~     follow-up period. Eligible subjects will be randomized to one of the following double-blind~     treatment groups FF/UMEC/VI 100 micrograms (mcg)/62.5 mcg/25 mcg once daily (QD), FF/VI 100~     mcg/25 mcg QD, or UMEC/VI 62.5 mcg/25 mcg QD~   "
107179|NCT02164500|"~     The Purpose of this trial is:~        -  to determine the overall response rate (ORR, complete response [CR] + partial response~          [PR]) in patients with relapsed or refractory HL~        -  to determine the safety profile of ruxolitinib in patients with relapsed or refractory~          HL~   "
107180|NCT02164487|"~     Vitamin B1 (Thiamine) is a water soluble essential nutrient; it is synthesized by a variety~     of plants and microorganisms. Since animals usually cannot synthesis it, humans must be~     supplied with exogenous vitamin B1 in the diet. The human storage of thiamine is small- about~     30mg, an intake of 1-2 mg a day is needed to maintain this pool. Deficiency might occur when~     the vitamin is depleted from the diet in a short period. Vitamin B1 has a role in energy~     metabolism and main biosynthetic pathways. Low thiamine causes illnesses in the central and~     peripheral nervous systems as well as affecting the heart and gastrointestinal systems.~      Deficiency may occur from malnutrition of different mechanisms such as alcoholism, lack in~     diet and recently secondary to anti-obesity surgery and few case reports described eating~     disorders as the reason for developing deficiency causing neuropathy, (1,2) and~     encephalopathy (3,4,5).~      One of the presentations of thiamine deficiency is peripheral neuropathy mimicking~     Guillain-Barre syndrome, and administering the lacking vitamin improves the symptoms.~      One study examined the prevalence of vitamin B1 deficiency in adult anorexia nervosa patients~     (6) by measurement of the activation of the enzyme erythrocyte transketolase following~     addition of thiamin pyrophosphate and comparing them to control of blood donors. This study~     found significant lower levels of vitamin B1 in the anorectic patient compared to the~     controls.~      Rational of the study:~      The investigators assume that these few cases described of overt neurologic impairment due to~     vitamin B1 deficiency because of distorted eating are just the tip of the iceberg and more~     eating disorders patients lack thiamine, that may have neuropsychiatric effect on the illness~     and identifying and treating the shortage may improve the symptoms of the disorder and maybe~     even the distorted thoughts that are fundamental in eating disorders.~   "
107181|NCT02164474|"~     Exercise is a proven strategy for preventing type 2 diabetes. Traditionally individuals have~     been prescribed moderate-intensity continuous aerobic exercise but adherence to this standard~     exercise program is dismal. High-intensity interval training (HIIT) is a novel form of~     exercise that involves brief, repeated bursts of vigorous exercise separated by periods of~     recovery. HIIT elicits many favourable cardiometabolic adaptations that are similar to~     traditional exercise but does so with a lower amount of exercise and in substantially less~     time than moderate-intensity continuous exercise. Therefore, HIIT has been touted as a~     time-efficient exercise strategy for improving health. Whether overweight individuals at~     risk for pre diabetes will show greater adherence to HIIT than moderate-intensity continuous~     exercise over the long-term (12-months) has not been tested. Because exercise adherence~     requires complex self-regulation, interventions designed to improve adherence should include~     a behavioural component. The investigators will assess adherence to HIIT and~     moderate-intensity continuous exercise over 12 months following a short-term (2 week)~     intervention of either HIIT or moderate-intensity continuous exercise. Both conditions will~     include a self-regulatory component targeted to increase participants' confidence to engage~     in regular, independent exercise. The results will help determine whether HIIT is a more~     feasible option for promoting exercise adherence for pre diabetes prevention than the~     traditional moderate-intensity continuous exercise. The investigators hypothesize that a)~     over the 12 months follow-up subjects randomized to the HIIT will be more likely to adhere~     when compared to moderate-intensity continuous exercise, b) over the 12 months follow-up~     subjects randomized to HIIT will have higher rates of adherence and levels of total physical~     activity, c) greater increases in self-regulation (including goal setting, self-monitoring,~     and self-regulatory efficacy) following HIIT will mediate higher rates of adherence, d)~     10-days of HIIT and moderate-intensity continuous exercise will improve cardiorespiratory~     fitness, increase insulin sensitivity, reduce circulating inflammatory markers, and improve~     glucose control and e) Improvements in cardiometabolic health factors will be greater~     following HIIT compared to moderate-intensity continuous exercise.~   "
107182|NCT02164461|"~     To evaluate the tolerability and safety of ADXS11-001 (1 x 10^10 colony forming units [cfu])~     administered with prophylactic premedication in repeating 3-dose study cycles in women with~     persistent, metastatic, or recurrent squamous and non-squamous carcinoma, adenosquamous, or~     adenocarcinoma of the cervix. To evaluate tumor response and progression-free survival (PFS,~     time to progression) by immune-related Response Evaluation Criteria in Solid Tumors~     (irRECIST).~   "
107183|NCT02164448|"~     The investigators hypothesized that sympatholytic effect of dexmedetomidine would attenuate~     the hemodynamic instability and decrease in the splanchnic blood flow caused by~     pneumoperitoneum during laparoscopic surgery. This study is to investigate the effect of~     intraoperative dexmedetomidine infusion on postoperative bowel movement in patients~     undergoing laparoscopic gastrectomy.~   "
107184|NCT02164435|"~     This is a prospective, single centre clinical investigation looking at short (6 months) and~     long term (24 months) changes in cardiac function and renal function in patients with~     drug-resistant hypertension post renal sympathetic denervation.~   "
107185|NCT02164422|"~     Evaluating the effect of guanfacine on alcohol consumption. The investigators hypothesize~     that guanfacine versus placebo will decrease the number of drinks consumed during the 2-hour~     self-administration period across stress and neutral/relaxing conditions.~   "
107186|NCT02164409|"~     This is a research study for patients who currently have or previously had an H. pylori~     infection and who plan to undergo an endoscopy as part of their care. The purpose of this~     study is to find out how and why H. pylori infections can cause progression to gastric cancer~     and if it's possible for intervention prior to this progression.~   "
107187|NCT02164396|"~     The aim of the study is to investigate how Lid-Parallel Conjunctival Folds recovers or~     persists after the continued usage or discontinuation of contact lenses or refitting with low~     coefficient of friction lenses.~   "
107188|NCT02164383|"~     The objective of this research is to determine whether smartphone games show promise for~     helping smokers increase their chances of quitting. The central hypothesis is that smokers~     who have access to smartphone games during their quit smoking attempt will smoke fewer~     cigarettes and report less craving than will smokers without such access.~   "
107256|NCT02163499|"~     The Open-Label Maintenance Study contains an Acute Phase, in which subjects will be dosed~     with ZS 10 g three times daily (tid) for 24 to 72 hours, followed by a long-term Maintenance~     Phase.~   "
107189|NCT02164370|"~     Acid/base imbalances are not well understood in pre-eclamptics, and better tools are needed~     to allow a thorough and meaningful evaluation. Disorders of electrolytes and albumin are~     common findings [13, 14], and the impact of such disorders on acid-base homeostasis has~     increasingly been acknowledged [4, 15]. The purpose of this prospective case-control study is~     to evaluate acid-base status in 100 women with mild or severe pre-eclampsia and 25 healthy~     controls by applying the Stewart Fencl's physicochemical acid-base model. We hypothesize that~     several simultaneous, and possibly offsetting, metabolic acid-base disorders will be~     identified and quantified, and that these may be useful to guide clinicians in their medical~     management and indication for delivery. Intermediate and long-term goals are to evaluate the~     ability of the Stewart Fencl's physicochemical acid-base model to guide fluid management and~     predict maternal and neonatal outcomes.~   "
107190|NCT02164357|"~     This study will compare two ways of treatment for acute ischemic stroke: an endovascular~     treatment (EVT), defined as intraarterial thrombolysis and/or mechanical thrombectomy as a~     first choice treatment versus intravenous thrombolytic therapy (IVT) only or followed by EVT~     in patients with acute ischemic stroke due to a main brain artery occlusion within 4.5 hours~     after onset. Patients treated with IVT only or with IVT followed by EVT will be analyzed~     separately.~   "
107191|NCT02164344|"~     Combined antiretroviral therapy (cART)-treated patients have increased mortality and~     morbidity compared to age-matched seronegative individuals. This increased mortality and~     morbidity has been associated to immune activation that persists also in patients under cART~     even with undetectable levels of HIV-RNA in blood. Indeed, HIV-infected patients,~     irrespective of cART treatment, show higher levels of activated T cells, inflammatory~     monocytes and proinflammatory cytokines than seronegative individuals. Several putative~     causes of this residual inflammation have been proposed and include ongoing HIV replication~     at low levels, the presence of coinfections such as cytomegalovirus, and microbial~     translocation.~      None of these causes are mutually exclusive and understanding the degree to which of these~     three cause residual inflammation in cART-treated individuals will require novel therapeutic~     interventions aimed at alleviated each putative cause.~      In this longitudinal study we aim:~        1. to reduce microbial translocation induced inflammation in cART-treated individuals with~          supplementation of cART with the probiotics.~        2. to investigate the potential benefits of 24 weeks of probiotics supplementation on~          immune function and on immune activation status~      Indeed, the early stage of HIV infection is associated with dysbiosis of the GI tract~     microbiome with reducted levels of bifidobacteria and lactobacillus species with increased~     levels of potentially pathogenic proteobacteria species.~   "
107192|NCT02164331|"~     Aim 1: The purpose of the study is to implement the Seventh Joint National Committee on the~     Diagnosis, Prevention and Treatment of Hypertension (JNC VII) recommendation for monthly~     visits for hypertensive patients with uncontrolled blood pressure (BP) using a~     theoretically-informed, empirically grounded, multimodal quality improvement (QI)~     intervention.~      Aim 2: To improve BP control and reduce disparity in BP through implementation of monthly~     visits.~      Aim 3: To assess potential mediators and moderators of the intervention.~   "
107193|NCT02164318|"~     This project will examine if enhancing Nitric Oxide (NO) bioavailability increases the rates~     of arteriovenous fistula (AVF) maturation in end stage renal disease patients requiring~     vascular access for hemodialysis. To enhance NO bioavailability the study team will utilize a~     program of forearm exercise training, application of nitroglycerin ointment or both. Goals of~     this study are (A) to measure if recruited subjects can tolerate the intervention protocols,~     and determine if dependent variable measures, including surgery outcome, and measurement of~     physiologic and biologic markers, can be obtained; (B) To measure subject compliance and~     adherence rates for each of the intervention arms and testing visits; (C) To examine which~     intervention or combination of interventions demonstrates the strongest preliminary effects~     in order to estimate power for a pivotal intent to treat trial; and (D) explore group~     differences in clinical vascular markers and biologic markers in vein tissue.~   "
107194|NCT02164305|"~     Dynamic control of the rotator cuff muscles plays an important role in stabilizing the~     shoulder during motion. Impairment in the neuromuscular control of these muscles may to lead~     to injury and pain. Rehabilitation programs have moderate success in decreasing pain and~     improving shoulder function. While most of these programs target the rotator cuff, it is~     still unknown if they serve to improve the neuromuscular control of the rotator cuff muscles.~     The rehabilitation may induce neurological and physiologic changes in neuromuscular~     structures and thus alter the neuromuscular control of the entire shoulder complex.~     Kinematics and electromyographic (EMG) activities have been widely used to study~     neuromuscular control. However, corticospinal excitability, which has been widely examined in~     the patients with neurological disorders, provides a more detailed account of central control~     from the primary motor cortex through the spinal cord to the muscles. This assessment of~     neuromuscular control will serve to illuminate the ability of the shoulder muscles to handle~     the stress from activities such as overhead sports activities and carrying or lifting heavy~     objects. This approach could be used to help design efficient training program for athletes~     and effective rehabilitation program for patients with shoulder injuries. The purpose of the~     proposed study is to investigate the effect of exercise treatment effect on the~     proprioception, kinematics, EMG and corticospinal excitability of shoulder muscles, including~     the deltoid and rotator cuff muscles.~   "
107195|NCT02164292|"~     The possibility to achieve a curative resection in patients with liver malignancies is~     limited by the future liver remnant (FLR). The Associating Liver Partition and Portal vein~     ligation for Staged hepatectomy (ALPPS) approach has recently been introduced as a~     revolutionary strategy to achieve resectability by inducing a rapid and large FLR~     hypertrophy. However, the possibility of achieving a short-term hypertrophy and high~     resectability rates has been counteracted in most published series by an increased risk of~     morbidity and mortality.The aim of this study was to evaluate the results with the ALPPS~     procedure in a single high-volume HPB center, with special emphasis in the safety and~     feasibility of this new 2-stage strategy. The aim of the present study was to assess the~     safety, feasibility and efficacy of ALPPS in a single high-volume hepatobiliary center.~   "
107279|NCT02163200|"~     Patients candidates for total hip replacement are, generally elderlies and have hip pain, we~     will check if the pressure to the soft tissue changes before and after operation using a~     tapet with pressure sensors sending the information to specific software.~   "
107196|NCT02164279|"~     About 30 to 40% of patients suffering from type I diabetes are at risk of developing a~     diabetic nephropathy (DN) leading more or less rapidly to an end-stage renal disease.~     Nowadays, the microalbuminuria is the most often used clinical parameter for possible onset~     of DN. However, it is a late (because it permits to detect a renal disease already present),~     non-specific and low sensitive biomarker.~      Therefore the main objective of this study is to identify early urinary biomarkers predictive~     of DN in children with type I diabetes, before the appearance of a microalbuminuria.~   "
107197|NCT02164266|"~     This study is designed to investigate the safety, tolerability, pharmacokinetics, and~     pharmacodynamics of RO6799477 following once daily oral administration for 2 weeks in healthy~     volunteers (Part 1) and in Type 2 diabetes patients (T2D) (Part 2). The anticipated time on~     study treatment is two weeks.~   "
107198|NCT02164253|"~     The FAIR-ALS study is to investigate the safety and efficacy of a scavenger treatment of iron~     deferiprone, which would reduce the brain iron to limit the development of amyotrophic~     lateral sclerosis.~      It has been shown an excess of iron in the central nervous system carrying a sporadic ALS~     patients. Iron overload associated with a loss of motor neurons may explain the signs of the~     disease (atrophy).~      The investigators discuss the hypothesis that reducing excess iron, the investigators can~     reduce the loss of neurons and thus the progression of signs of the disease.~   "
107199|NCT02164240|"~     The purpose of this research study is to determine the safety and tolerability of sunitinib~     alternating with regorafenib in participants with advanced gastrointestinal stromal tumor~     GIST, if the standard approved therapies (imatinib, sunitinib and regorafenib) have failed to~     control the disease. Additionally, this study seeks to determine the highest dose that can be~     given safely for this combination of drugs.~   "
107200|NCT02164227|"~     The effectiveness of breathing exercise on anxiety in women during the first period of labor.~   "
107201|NCT02164214|"~     TWEAK (TNF weakly inducer of apoptosis) is a type II-transmembrane protein, member of the TNF~     ligand superfamily that can be cleaved to function as a soluble cytokine. Depending on target~     cell type, TWEAK triggers multiple cellular responses ranging from modulation of inflammation~     to cell death when it binds to its main receptor, Fn 14. Our team has been the first to~     describe pro-inflammatory effects of TWEAK during central nervous system inflammation.~     Various data support the possibility that TWEAK produced by synovial macrophages may~     contribute to chronic synovitis in animal models and in humans. In psoriatic arthritis~     (PsoA), anti-TNF therapy has been successful concording with the key role of TNF in the~     pathogenesis of this disease and the generation by psoriatic patients of neutralizing~     anti-TNF autoantibodies referred as beneficial autoimmunity to pro-inflammatory mediators.~     In 2010, Van Kuijk et al. have described a high expression of TWEAK in the inflammatory~     synovial of PsoA and rheumatoid arthritis (RA) patients before and after anti-TNF therapy.~     The role of TNF-alpha in the regulation of TWEAK expression remains unclear.~   "
107202|NCT02164201|"~     This is a prospective, multicenter, single-arm study designed to collect clinical data to~     support the safety and effectiveness of BioFoam used as a surgical adjunct to anastomotic~     hemostasis following cardiovascular surgery.~      The overall objective of this clinical study is to collect clinical data supporting the~     safety and effectiveness of BioFoam used as a surgical adjunct to anastomotic hemostasis~     following cardiovascular surgery. This study is intended as a post-market surveillance~     (follow-up) study.~   "
107203|NCT02164188|"~     This protocol proposes a well-being program based on meditation and Positive Psychology~     principles such as human development, the improvement of virtues, quality of life and~     well-being. The investigators hypothesize that this program may promote well-being and reduce~     stress related problems in the participants. Objectives: To evaluate the efficacy of a~     well-being program in a sample of managers who work in a company (Natura Inovação/Cosméticos~     ) and health care professionals who work in a hospital (Hospital Israelita Albert Einstein)~     as well as its implication in the work environment. Methods: Sixty managers from Natura~     Inovação/Cosméticos and 60 health professionals from Hospital Israelita Albert Einstein will~     be recruited. The participants will be randomized in two groups of 30 participants each one,~     half of them in the control group (GC) and the other half to the intervention group (GI).~   "
107204|NCT02164175|"~     Data Collection Registry of the HeRO Graft for End Stage Renal Disease Patients Receiving~     Hemodialysis~   "
107205|NCT02164162|"~     In Parkinson's disease, gait disturbances represent one of the most disabling motor symptoms,~     frequently associated with an increased risk of falls, loss of independence and a negative~     impact on quality of life. In recent years, the interest in automated robotic devices for~     gait training for Parkinson's Disease patients has grown. With their consistent, symmetrical~     lower-limb trajectories, robotic devices provide many of the proprioceptive inputs that may~     increase cortical activation and improve motor function while minimizing the intervention of~     a therapist. So the main aim of this study will be to analyze, through a clinical and an~     instrumental evaluation, the effectiveness of a Lokomat gait training in subjects affected by~     Parkinson's disease in comparison to a ground conventional gait training.~   "
107206|NCT02164149|"~     The quality of colon cancer surgery is highly debated these years since the mortality of the~     disease is not declining markedly. Surgery is the main treatment of colon cancer and during~     surgery it is very important for the surgeon to remove the tumour and all potential ways of~     tumour spread. As colon cancer first of all spreads to the nearby lymph nodes lying along the~     tumour feeding artery the surgeon aims to cut the vessel as central as possible. This means~     that all of the tumour feeding artery should have been removed after surgery.~      In this study the investigators want to measure the length of the tumour feeding artery after~     surgery as a quality control of the surgery. The investigators hypothesize that the artery~     will be shorter than 5 mm.~      The investigators wish to CT scan all patients two days after colon cancer surgery and~     afterwards measure then length of the artery on the images. This study will not inflict with~     the normal routine for patient information and treatment.~   "
107221|NCT02163954|"~     Patients with severe chronic kidney disease or end stage renal disease (ESRD) on hemodialysis~     (HD) exhibited higher platelet reactivity to clopidogrel than did those with normal renal~     function. Not enough study has been conducted about the antiplatelet effects of ticagrelor in~     these cardiovascular high risk patients. We hypothesized ticagrelor would achieve more and~     faster antiplatelet effects compared with clopidogrel in ESRD patients on HD.~   "
107207|NCT02164136|"~     TME (Total mesorectum excision) is the golden standard of radical resection for mid-low~     rectal cancer. However, the damage of pelvic autonomic nerve following with TME principle~     will lead to high incidence of urinary and sexual function disorder. Open PANP (pelvic~     autonomic nerve preservation) TME surgery played a role in decreasing incidence of urinary~     and sexual function disorder. However, 32%-44% patients still suffered from urinary and~     sexual function disorder when underwent Open PANP TME surgery (O-PANP-TME).~      Laparoscopy-assisted TME surgery (L-TME) is applied wildly nowadays. In the early stage of~     work, we performed laparoscopy-assisted PANP TME surgery (L-PANP-TME) to discuss the~     protection of urinary and sexual function of male mid-low rectal cancer patients. The results~     showed that L-PANP-TME significantly decreased incidence of urinary and sexual function~     disorder. In order to further confirm our early work, we design a randomized controlled~     clinical trial to compare differences in urinary and sexual function protection and long-term~     outcomes between L-PANP-TME and O-PANP-TME.~   "
107208|NCT02164123|"~     The purpose of this study is to determine whether passive accessory intervertebral~     mobilization applied to the fourth thoracic vertebra produces autonomic effects.~   "
107209|NCT02164110|"~     The purpose of this study is to evaluate the efficacy (Immunogenicity) and Safety of Euvichol~     in Healthy Adults and Children.~   "
107210|NCT02164097|"~     This study will be with pediatric patients who have refractory/recurrent solid tumors. They~     will receive standard chemotherapy (ICE) and we are investigating if the addition of a new~     drug, ODSH, will help to increase the time of their platelet recovery after ICE~     chemotherapy.The purpose of this study is to evaluate the safety and tolerability of ODSH in~     pediatric patients receiving ICE chemotherapy.~   "
107211|NCT02164084|"~     This study will identify how much (if any) drug is absorbed from the skin of subjects with~     acne vulgaris after topical application of SB204.~   "
107212|NCT02164071|"~     The elderly comprise the most prevalent population in oncology practice. The available~     evidence suggests that old patients are undertreated patients, mainly because of their~     advanced age, regardless of whether they are highly functional patients, they do not present~     co morbidities and could benefit from oncology therapies.~      Treatment planning must consider several health indices that are useful when it comes to~     detecting geriatric problems that could affect the patient's treatment experience. The~     complete comprehensive geriatric evaluation stands out as cornerstone among other validated~     tools that do not work as isolated instruments; however, its length and complexity may hinder~     its routine use in clinical practice for decision making.~      The purpose of this study is to validate a comprehensive health status assessment scale in~     elderly patients (≥65 years) with hematological malignancies that, while integrating the~     essential dimensions of geriatric assessment and, with the same precision as the currently~     available valid tools, is shorter and easier to apply, so it can be incorporated into the~     daily practice and that aids in clinical decision making objectively.~      If so, this information would help identify patients that could benefit from a specific~     oncology treatment, thus contributing to developing a targeted intervention plan and to~     optimizing the cancer results in this patient population.~   "
107213|NCT02164058|"~     The purpose of this study is to determine if a device known as the TandemHeart® System~     (TandemHeart) can help limit heart damage and reduce serious complications after a certain~     type of heart attack (acute ST elevation anterior wall myocardial infarction [STEMI]) by~     evaluating the use of the TandemHeart system prior to a procedure called percutaneous~     coronary intervention (PCI)~   "
107214|NCT02164045|"~     The current food effect study is being performed to support a Phase 3 study with BMS 663068.~     Results from this study will inform whether patients in the upcoming Phase 3 study can be~     given the flexibility to dose BMS-663068 in the fasted state, if so desired.~   "
107215|NCT02164032|"~     Non-alcoholic fatty liver disease (NAFLD) is a common human liver pathology, closely~     associated with the obesity pandemic and insulin resistance. In the insulin resistant state~     the liver remains sensitive to pro-lipogenic signals of insulin, which further promote lipid~     accumulation. Secretion of very-low-density-lipoproteins (VLDL), the main carriers of~     triglycerides (TG) in the plasma, is the principal pathway for the liver to mobilize and~     dispose of lipids. Thus, hepatic TG export must not be too low in order to prevent steatosis.~     Our preliminary data from animal experiments suggest that enhanced brain insulin signaling~     promotes hepatic VLDL secretion, and reduces lipid accumulation in the liver. It remains to~     be tested whether other insulin sensitive tissues, such as the myocardium or the skeletal~     muscle, are also affected. In humans, neuropeptides, including insulin, can be delivered to~     the brain via an intranasal (IN) route of administration, without causing relevant systemic~     side effects.~      Therefore, we hypothesize that by enhancing brain insulin signaling using chronic IN insulin~     administration hepatic TG export increases and prohibits lipid accumulation in the liver and~     other insulin sensitive tissues, such as the myocardium and the skeletal muscle.~   "
107216|NCT02164019|"~     The purpose of this study is to look at two different types of surgeries regularly used for~     treating cancer that has spread to and weakened the thigh bone (femur). Because it is not~     known which of these surgeries is best, the investigators will compare the results of the two~     procedures. They are looking to see if differences exist (after surgery) in function, quality~     of life, pain control, and possible complications.~   "
107217|NCT02164006|"~     The purpose of this study is to evaluate the safety and effectiveness of TGR-1202 in~     combination with brentuximab vedotin in patients with hodgkin's lymphoma.~   "
107218|NCT02163993|"~     The main purpose of this study is to evaluate whether the study drug known as LY2951742 is~     safe and effective in the prevention of migraine headaches. The study will last between 28~     and 36 weeks.~   "
107219|NCT02163980|"~     The investigators perform this study to evaluate the effects of caudal Dexmedetomidine (DEX)~     added to high volume/low-concentration of ropivacaine in children undergoing orchiopexy.~   "
107220|NCT02163967|"~     The hypothesis is that CES stimulation will dose dependently increase parasympathetic tone.~     Healthy subjects will have three 20 minute sessions of CES stimulation, at three different~     intensities of stimulation, with each session occurring on a separate day. Effect on~     parasympathetic tone will determined by measuring high frequency heart rate variability~     before, during and after the stimulation. The Fisher Wallace Stimulator (FW100) which~     delivers a low dose alternating current a varying frequencies will be used for the~     stimulation.~   "
107222|NCT02163941|"~     For individuals suffering from posttraumatic stress disorder (PTSD), the emotional numbing~     and isolation that are a core aspect of their suffering and consistently impedes remediation~     often remains after first-line treatments are administered. Few interventions have proven~     successful for enhancing the empathy and social connectedness that will ultimately allow~     patients to flourish, and the search for target therapies is made more difficult by the fact~     that very little is known about the underlying physiology of emotional numbing and social~     isolation. The proposed study is designed to (1) investigate the hormonal, neural and~     immunological biomarkers related to emotional numbing, and (2) test whether cognitively-based~     compassion training (CBCT), an intervention designed and proven to enhance empathy, will~     reduce emotional numbing and increase empathy and social connectedness in veterans. To this~     end, thirty medically healthy males diagnosed with PTSD who continue to report emotional~     numbing symptoms after prolonged exposure therapy will receive 8 weeks of training in CBCT.~     Prior to, and again after the training, the investigators will assess patients' levels of~     oxytocin, inflammation, and self-reported emotional numbing and social connectedness. The~     investigators will also assess their neural response during a video task that assesses their~     ability to accurately read others' emotions. The investigators hypothesize that oxytocin,~     neural activity, and inflammation will predict social numbing, isolation, and empathy, and~     also that CBCT will positively impact the social outcomes that will pave the way toward~     health and well-being.~   "
107223|NCT02163928|"~     Skin Carotenoid Scores (SCS) are a biomarker of overall antioxidant status. This study will~     use Raman Spectroscopy to examine the ability of increased dietary intake of fruits and~     vegetables to increase SCS in medical students. This will be an observational, non-invasive~     study examining skin carotenoid levels over time in individuals who have increased their~     intake by dietary adjustments. Thirty medical students meeting study inclusion criteria will~     be asked to increase their intake of high antioxidant fruits and vegetables to 4-6 cups per~     day over an eight week period of time. Students will self-select their fruits and vegetables~     from a given list and will receive supermarket gift cards to offset the cost of the increased~     food. Students will be asked to follow their usual diet for one week. Then increase their~     intake of high antioxidant fruit and vegetable to 4-6 cups per day for eight weeks. Then~     return to their usual diet for 2 weeks. SCS scores will be taken at baseline and week 1. At~     the beginning of week 2, students will be asked to increase fruit and vegetable intake to 4-6~     cups per day. SCS will be measured every two weeks during the 8-week intervention phase.~     Students will return to their usual diet for 2 weeks and SCS will be measured at the end of~     that 2-week period.~   "
107224|NCT02163915|"~     The purpose of this study is to characterize the safety and tolerability of TAK-137 when~     administered as multiple oral doses in adults with attention-deficit/hyperactivity disorder~     (ADHD).~   "
107225|NCT02163902|"~     To investigate the long-term safety and maintenance of efficacy of ATX-101 in reduction of~     submental fat.~   "
107226|NCT02163889|"~     The objective of this study is to investigate T2Candida performance as a monitoring tool for~     post-therapy clearance of Candida compared to blood culture.~      This study will collect a T2clinical specimen and companion blood culture from patients who~     have exhibited a positive blood culture by gram stain for yeast, and who are receiving~     treatment with antifungal therapy.~   "
107227|NCT02163876|"~     This study will evaluate the safety and efficacy of human central nervous system stem cell~     transplantation into patients with traumatic injury in the cervical region of the spinal~     cord.~   "
107228|NCT02163863|"~     Primary purpose of the Mimics Study is to evaluate the safety and performance of the~     BioMimics 3D Stent System in the treatment of symptomatic SFA/proximal popliteal disease.~   "
107229|NCT02163850|"~     Prospective, randomized, unblinded, multi-center investigational study with enrollment at up~     to 45 investigational sites. The study is designed to compare the study device (Direct Flow~     Medical Transcatheter Aortic Valve System) composite event rate to a blended commercial~     comparator (using approved Medtronic self-expanding bioprosthesis or Edwards~     balloon-expandable bioprosthesis) in high and extreme risk Subjects with severe symptomatic~     aortic stenosis. Subjects will be followed through the index procedure, hospital discharge,~     and at 30 days, 6 months and 1 year for the primary endpoint analysis. Thereafter, annual~     follow-up at 2 through 5 years will be conducted and analyzed separately.~   "
107230|NCT02163837|"~     Hepatic encephalopathy is responsible for sleep disturbances and daytime sleepiness. The~     purpose of our study is to assess sleep quality, quantity, sleep schemes and physical~     activity in patients suffering from HE, before and after a 2 weeks treatment with rifaximine,~     which is currently given to lower blood ammoniac levels.~   "
107231|NCT02163824|"~     The primary purpose of this study is to determine the efficacy and safety of KPI-121~     ophthalmic suspension compared to placebo in subjects who have undergone cataract surgery.~     The efficacy and safety of two different concentrations and two different dosing regimens of~     KPI-121 are also being assessed.~   "
107232|NCT02163811|"~     Lower extremity amputations are a significant cause of morbidity, mortality, loss of function~     and reduced quality of life. Self-management (defined as the process by which an individual~     adopts an active role in managing the symptoms, treatment, consequences, and lifestyle~     changes inherent in living with a chronic condition) is an important mechanism for improving~     health and reducing disability. This study will evaluate a 5-week group-based self-management~     intervention for Veterans with lower extremity limb loss (VETPALS) and determine its impact~     upon physical and psychosocial functioning, patient activation, self-efficacy, problem~     solving, quality of life and positive affect. This study represents one of the only~     prospective randomized controlled trials of a behavioral intervention for individuals with~     limb loss. It is expected that results will be used to inform the integration of~     self-management interventions into the VA Amputation System of Care. The specific primary~     hypotheses are:~        1. Individuals randomized to VETPALS will display greater improvements from baseline in~          physical functioning as measured by the MFA-SF than Veterans in the individual education~          support condition post-intervention and at a 6 month follow-up.~        2. Individuals randomized to VETPALS will display greater improvements from baseline in~          psychosocial functioning as measured by the PHQ-9 than Veterans in the individual~          education support condition post-intervention and at a 6 month follow-up.~   "
139097|NCT01746641|"~     The purpose of this study was to compare remifentanil and propofol for sedation of patients~     during endoscopic gastrointestinal procedures.~   "
107233|NCT02163798|"~     Cardiovascular diseases (CVD) accounted for major mortality and morbidity rates in Hong Kong~     (HK) other than cancer. Increasing energy expenditure through regular exercise participation~     has been found to lower the risk of CVD such as hyperlipidemia and obesity. Healthcare~     professionals often prescribe lifestyle exercises for disease prevention, rehabilitation, and~     health maintenance purposes. Previous study revealed that Tai Chi and walking were widely~     practice by HK citizens. However, limited studies are found to compare the health benefits~     between Tai Chi and walking. Do Tai Chi and walking have equally effective in raising~     metabolic rate and reducing CVD risks? The difference in energy cost between a single bout of~     Tai Chi and walking has not been documented. Limited studies report the effects of Tai Chi in~     lowering the CVD risk. Since walking and Tai Chi are being heavily promoted in HK in recent~     years, there is an urgent need to document the evidence of these two common forms of exercise~     in terms of reducing CVD risks. Therefore, the purpose of the present study was to~     investigate the energy costs as well as CV health benefits, in terms of aerobic fitness, body~     composition, blood pressure, and blood lipid profiles, from the walking and Tai Chi exercise~     in a sample of HK Chinese adults, and to compare the effects between these two exercises. The~     investigators hypothesized that Tai Chi and walking had similar effects on improving energy~     cost and reducing CVD risks.~   "
107234|NCT02163785|"~     Prospective multicenter randomized controlled trial comparing the prone vs. the supine~     position of the perineal time of the Miles operation in patients with advanced rectal cancer.~      Primary objective:~      - Pathological circumferential resection margin~      Secondary objectives:~        -  5 year oncological outcomes~        -  Morbimortality rates~        -  Surgical specimen quality~        -  Perineal hernia incidence~   "
107235|NCT02163772|"~     Backgrounds: Unilateral vocal cord paralysis caused from recurrent laryngeal nerve (RLN)~     injury is not an unusual disease and may deteriorate patients'voice and swallowing outcomes.~     Although the long term treatment effect is encouraged, the point when to perform surgical~     treatment is not conclusive. Previous reports suggested late treatment principle because~     patients may spontaneous reinnervation to some degree within 4-5 months after injury. The~     vocal cord position and tone may change during reinnervation. Others delineated laryngeal~     synkinesis by misdirected reinnervation is common and suggested early temporary injection~     laryngoplasty. They implied early injection laryngoplasty may improve patients'not only short~     term voice outcomes but also decrease the incidence of transcervical laryngeal framework~     surgery as a determined surgery. However, lacking of prospective study and objective data~     makes the treatment-time policy still controversial. Purposes: 1. To find incidence of~     spontaneous reinnervation or synkinetic regeneration. 2. To detect the relationship between~     changing of glottal gap and laryngeal synkinesis. 3. To detect the impaction of early~     intracordal hyaluronic acid injection on vocal cord position change in patients with~     laryngeal synkinesis. Study design: Forty patients is planned to be enrolled in the study.~     Twenty of them will undergo hyaluronate intracordal injection at three-six month from RLN~     damage. The other 20 patients will follow the watch-and wait policy. Laryngoscope, laryngeal~     EMG (electromyography), voice analysis and voice outcome survey will be done at 3-6 month and~     12-month after RLN injury. At the end of follow up, the glottal gap, voice laboratory data~     and quality of life will be compared. The outcomes will also be correlated with laryngeal~     electromyography (LEMG) data and the impact of synkinetic reinnervation.~   "
107236|NCT02163759|"~     This Phase III, double blind, placebo and active comparator controlled, multicenter study~     will investigate the efficacy and safety of etrolizumab in induction of remission in~     participants with moderately to severely active UC who are naIve to TNF inhibitors and~     refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment.~   "
107237|NCT02163746|"~     This study compares two well-known treatment options for Stage 2 hidradenitis suppurativa:~     carbon dioxide (CO2) laser excision versus surgical deroofing.~   "
107238|NCT02163733|"~     This is a 2-part study in patients with epidermal growth factor receptor mutation positive~     (EGFRm+) non-small cell lung cancer (NSCLC) whose disease has progressed on treatment with an~     epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI): Part A will~     determine the effect of food on the pharmacokinetics (PK) of AZD9291; Part B will allow~     patients further access to AZD9291 and will provide for additional safety data collection.~      Part A is a randomised, open-label, 2 treatment period crossover study in which patients will~     each receive a single oral dose of AZD9291 (1 x 80 mg tablet) at breakfast time~     (approximately 0800) in each of 2 treatment periods (once immediately following a high fat~     meal [fed], and once in the fasted state [fasted]), with a washout period of 9 days between~     doses.~      Approximately 38 patients are planned to be enrolled and dosed; at least 30 evaluable~     patients will be required to complete Part A (ie, the last PK sample in Treatment Period 2~     [TP 2] has been collected). Additional patients may be enrolled to allow for at least 30~     evaluable patients.~   "
107239|NCT02163720|"~     The French cooperative group GINECO proposes to implement an observational study to describe~     a real situation, in daily practice tolerance and methods of administration of trabectedin~     (Yondelis®)-Pegylated liposomal doxorubicin(Caelyx)®, in ovarian platinum sensitive cancer~     relapse.~   "
107240|NCT02163707|"~     Psilocybin is a naturally occurring psychedelic compound produced by more than 200 species of~     mushrooms, collectively known as psilocybin mushrooms. Psilocybin~     (4-phosphoroyloxy-N,N-dimethyltryptamine) is a hallucinogenic tryptamine that was first~     isolated from Psilocybe mushrooms in 1957. The objective of this Phase I clinical trial is to~     determine the pharmacokinetics of oral doses of psilocybin in normal, healthy adults. The~     study is performed in support of Phase II and Phase III studies of psilocybin for the~     treatment of refractory anxiety associated with incurable cancer, as well as other possible~     indications. Psilocybin is at present not an FDA-approved drug.~   "
107241|NCT02163694|"~     The study seeks to evaluate the efficacy and tolerability of veliparib/placebo in combination~     with carboplatin and paclitaxel in HER2-negative metastatic or locally advanced,~     unresectable, BRCA-associated breast cancer.~   "
107242|NCT02163681|"~     The purpose of this study is to develop rapid MRI techniques for imaging the lung with~     hyperpolarized helium-3 gas as an inhaled contrast agent. These techniques will be piloted in~     adults and older children before testing them in younger children and infants. The purpose is~     to enable imaging of non-sedated infants by imaging so fast as to freeze motion.~   "
107243|NCT02163668|"~     This study examined the effects of 8 months of Yoga training on bone density and bone~     turnover markers in premenopausal women, ages 35-50 years. The style of Yoga used was power~     Yoga that involved postures with a jumping component. The investigators hypothesized that the~     Yoga intervention would result in beneficial improvements in bone turnover markers, by~     increasing the bone formation marker and decreasing the bone resorption marker.~   "
107244|NCT02163655|"~     The purpose of this study is to determine if furosemide administered after the first 24 hours~     of delivery, in women with severe peeclampsia and eclampsia accelerates high blood pressure~     control and diminishes hospital stay.~   "
107246|NCT02163629|"~     In spite of major medical advances in heart transplant patients, psychiatric comorbidity~     remains very high in pre-and post-transplant phases. Anxiety and depression are especially~     frequent. They impact significantly morbidity and mortality. Especially because they are~     associated with poor therapeutic adherence and risks of infection and rejection. The~     inability to make beneficial therapeutic choice can be explained by the negative perception~     of events, associated with anxio-depressive disorders. This results in an important~     deterioration in quality of life of patients.~      The investigators assume that better management of emotions might reduce the stress of~     waiting situation and its psychopathological and somatic consequences pre-and~     post-transplant.~   "
107247|NCT02163616|"~     This study seeks to assess whether populations of women in Latin America outside Quito,~     Ecuador are at increased risk for developing elevated body temperature above 40.0°C following~     PPH treatment with 800mcg sublingual misoprostol. The study will be carried out in hospitals~     representative of different regions of Latin America to explore environmental and genetic~     hypotheses related to the occurrence of misoprostol-induced fever. Postpartum blood loss,~     pulse and blood pressure will be systematically measured for all women enrolled to explore~     new clinical indicators for identifying women who require clinical intervention for excessive~     bleeding. Blood samples will be collected among women treated with misoprostol to investigate~     genetic factors responsible for elevated body temperature induced by misoprostol.~      The investigators hypothesize that rates of high fever (≥40.0°C) following misoprostol~     treatment (800mcg given sublingually) will be variable across settings. The investigators~     expect that the side effect profile following 800 mcg misoprostol given sublingually, in~     particular the rates of any shivering and fever ≥38.0°C, will be comparable to previous~     results using misoprostol for PPH.~   "
107248|NCT02163603|"~     Developmental dislocation of the hip is a common disease in children, and its incidence in~     China is about 9 ‰.The pathological changes of it is complex. The reluxation , subluxation~     and residual deformity and other complications are relatively common after treatment. The~     X-ray appears great acetabular index and wide medial gap , small central-edge angle. As there~     is no effective methods for treating such complications , investigators conducted this trial~     to find and prove optimal intervention time and treatment programs.~   "
107249|NCT02163590|"~     Passive mobilizations of the spine are widely used by physiotherapists in the management of~     neuromusculoskeletal disorders.~      There is a nascent body of work of the mechanical properties of joint mobilizations.~     Treatment dose is characterized by the direction of force applied, magnitude of force~     applied, frequency of oscillation, amplitude of displacement, repetition and time. Although~     the choice of better treatment dose is based on patient complaints and clinical reasoning,~     the comprehension of the effects of different parameters of joint mobilization will improve~     the decision making process. The optimal dose of treatment, however, is not already known.~      The primary aim of this study is to determine whether different rates of thoracic~     mobilization are capable to produces hypoalgesic effects, and secondarily investigate if such~     effects are local or widespread.~   "
107250|NCT02163577|"~     The objectives of the study are to:~        -  Identify a dose and dosing regimen of KRN23, based on safety and PD effect, in pediatric~          XLH patients~        -  Establish the safety profile of KRN23 for the treatment of children with XLH including~          ectopic mineralization risk, cardiovascular effects, and immunogenicity profile~        -  Characterize the PK/PD profile of the KRN23 doses tested in the monthly (Q4) and~          biweekly (Q2) dose regimens in pediatric XLH patients~        -  Determine the PD effects of KRN23 treatment on markers of bone health in pediatric XLH~          patients~        -  Obtain a preliminary assessment of the clinical effects of KRN23 on bone health and~          deformity, muscle strength, and motor function~        -  Obtain a preliminary assessment of the effects of KRN23 on patient-reported outcomes,~          including pain, disability, and quality of life in pediatric XLH patients~        -  Evaluate the long-term safety and efficacy of KRN23 Evaluate the long-term safety and~          efficacy of KRN23~   "
107251|NCT02163564|"~     Major depressive disorder (MDD) occurs at least 11% of adolescents and approximately 53-90%~     of those adolescents have insomnia. If left untreated, insomnia increases the risk of relapse~     and recurrence of depressive episodes, unintentional injuries, poor school performance,~     substance use, obesity, and the risk for suicide. This project seeks to develop a~     nonpharmacological treatment for insomnia in adolescents with depression that is feasible and~     effective. The specific methodologies that will help accomplish these results are: 1) use of~     focus groups of adolescents with depression and insomnia to determine how the current~     standard, nonpharmacological treatment for insomnia (cognitive-behavioral therapy for~     insomnia; CBTI) among adults can be modified for use by adolescents with depression and 2)~     determine the preliminary effectiveness, feasibility, and tolerability of group CBTI in~     adolescents with depression (CBTI-AD) developed using feedback from the focus groups. This~     project will help to improve the quality and scope of delivery of mental health services in~     Michigan by a) gaining a greater understanding of how sleep disturbance may perpetuate~     depression in adolescents and b) to provide mental health professionals with a~     nonpharmacological treatment option for insomnia in adolescents with depression.~   "
107252|NCT02163551|"~     Dyspnea is a subjective experience of breathing discomfort that consists of qualitatively~     distinct sensations that vary in intensity. It is known that sensory information from the~     respiratory system activates regions of the cerebral cortex to produce the perception of~     dyspnea but far less is known about the neurophysiology of dyspnea than about vision,~     hearing, or even pain. Dyspnea likely arises from multiple nervous system sources, but the~     exact locations have not been well identified. Investigations of the mechanisms underlying~     respiratory sensations have included studies of airway anesthesia, chest wall strapping,~     exercise, heart-lung transplantation, hyperventilation, and opioid use. Study of the~     perception of breathing sensations in individuals with a spinal cord injury presents~     additional opportunity. The goal of the proposed project is to examine the effects of~     increasingly severe levels of spinal cord injury on the perception of breathing sensations in~     participants who are able to breathe without the use of a ventilator. The investigators~     hypothesize that the perception of breathing varies with the extent of somatosensory~     information that reaches cerebral cortex.~   "
108526|NCT02146924|"~     This phase I trial studies the side effects and best dose of cellular immunotherapy in~     treating patients with high-risk acute lymphoblastic leukemia. Placing a modified gene into~     white blood cells may help the body build an immune response to kill cancer cells.~   "
107257|NCT02163486|"~     Airway management is one of the basic topics in anesthetic practice. Use of endotracheal~     intubation and face mask are standard methods to maintain an open airway widely adopted for~     many years. As a result of a search for more appropriate choices from the point of view of~     effectiveness, reliability and side effects, supraglottic airway devices (SGAD) have been~     developed.~      SGAD's are used for thyroid surgery, ear surgery, carotid endarterectomy, adenotonsillectomy~     and laser pharyngoplasty, which require a variety of head-neck positions. Changing the head~     and neck position leads to changes in the shape of the pharynx, which causes variation in the~     cuff pressure and oropharyngeal leak pressure. Oropharyngeal leak pressure values play a~     determining role in protecting the airway from high cuff pressure. Additionally it shows that~     the laryngeal mask is correctly placed and is a sign of the effectiveness of positive~     pressure ventilation. During surgery head-neck and trunk position may change. As a result~     there is a need for research evaluating the effect of head and neck position on oropharyngeal~     leak pressure during SGAD use.~      AIM~      The aim of this study is to compare the effect of different head and neck positions on the~     oropharyngeal leak pressure in LMA-Unique and I-Gel applications. Additionally the placement~     duration, ease and success of these two supraglottic airway devices will be compared.~   "
107258|NCT02163473|"~     The purpose of this research study is to determine if a chemical marker in the blood,~     hypoxia-inducible factor (HIF-1 alpha), can be used to predict subject's hospital outcomes~     when the subject is diagnosed with sepsis. Sepsis is defined as either the presence of~     pathogenic organisms or their toxins in the blood and tissues. Sepsis is one of the most~     significant challenges in critical care medicine. The investigators propose that~     hypoxia-induced expression of HIF-1 alpha will correlate with the clinical features of Sepsis~     and in the future, HIF-1 alpha may be used as a biomarker in Sepsis.~   "
107259|NCT02163460|"~     The aim of this study was to perform a randomised clinical trial comparing the use of~     closed-suction tubular drains and progressive tension sutures in individuals with large~     incisional hernias subjected to onlay mesh repair to evaluate the occurrence of seroma and~     surgical wound infection after surgery.~   "
107260|NCT02163447|"~     This will be a double-blinded randomized controlled phase III trial of 300 HIV uninfected~     pregnant women and the children born to them. The study interventions will be divided into~     two phases. In the first phase, HIV uninfected women at 12-20 weeks gestation will be~     randomized in equal proportions to one of three intermittent preventive therapy in pregnancy~     (IPTp) treatment arms: 1) 3 doses of sulfadoxine-pyrimethamine (SP), 2) 3 doses of~     dihydroartemisinin-piperaquine (DP), or 3) monthly DP. All three interventions arms will have~     either SP or DP placebo to ensure adequate blinding is achieved. Follow-up for the pregnant~     women will end approximately 6 weeks after giving birth. In the second phase of the study,~     all children born to mothers enrolled in the study will be followed from birth until they~     reach 36 months of age. Children born to mothers randomized to receive 3 doses of SP during~     pregnancy will receive DP every 3 months between 2-24 months of age. Children born to mothers~     randomized to receive 3 doses of DP or monthly DP during pregnancy will receive either DP~     every 3 months or monthly DP between 2-24 months of age. To ensure adequate blinding,~     children who will receive DP every 3 months will be given DP placebo during the months they~     will not be taking DP. Children will then be followed an additional year between 24-36 months~     of age following the interventions. We will test the hypothesis that IPT with DP will~     significantly reduce the burden of malaria in pregnancy and infancy and improve the~     development of naturally acquired antimalarial immunity.~   "
107261|NCT02163434|"~     The investigators will compare the effectiveness of gabapentin to metoclopramide for 1-2~     weeks among 80 women with hyperemesis gravidarum (HG) in this randomized, double-blinded~     trial. After completion of the 2-week double-blind phase, subjects will be offered open-label~     gabapentin with rescue metoclopramide until their symptoms no longer require treatment.~     Enrollment will occur at the University at Buffalo and the University of Rochester.~   "
107262|NCT02163421|"~     The purpose of this study is to assess the absolute bioavailability and pharmacokinetics of~     vedolizumab following a single injection of vedolizumab subcutaneously at 3 varying doses.~   "
107263|NCT02163408|"~     This is a technical development study with the goal to develop 3D techniques for~     atherosclerosis plaque characterization. We hypothesize that 3D MRI is superior to 2D MRI in~     characterizing major plaque constituents that contribute to severe clinical events such as~     myocardial infarction or stroke. The major advantages of the 3D techniques to be developed~     will include high spatial resolution, reduced scan times, and optimized image contrast. The~     use of contrast injection is not needed with the new techniques, which is greatly beneficial~     for patients with advanced chronic kidney disease.This is not a funded clinical trial.~   "
107264|NCT02163395|"~     -  Straumann Monotype FullCeram implants serve as a suitable alternative for implant~          therapy especially in the aesthetic zone~        -  The survival rate of Straumann Ceramic implants should be at least 85% (max 6 implant~          losses out of 40 patients) after the first year~   "
107265|NCT02163382|"~     Mechanical ventilation permits to support the work of breathing in case of respiratory~     failure, but therapy also has many side effects. Non-invasive ventilation (NIV), which~     delivers the ventilatory assist via a face mask or nasal canula, permits to decrease these~     complications. However, NIV is not always successful and half of children in respiratory~     failure finally require invasive ventilation. A major cause of NIV failure is the ventilator~     inability to detect patient efforts. The new ventilatory mode NAVA (neurally adjusted~     ventilatory assist) improves the detection of patient efforts during mechanical ventilation.~     The hypothesis of this study is that NAVA improves synchrony during pediatric NIV and~     therefore permits to unload the patient ventilatory efforts.~   "
107266|NCT02163369|"~     The purpose of this pilot study is to introduce the use of aromatherapy/essential oils to~     medical oncology patients at Central DuPage Hospital to assess their perceived effectiveness~     to relieve symptoms of nausea or vomiting and/or anxiety.~      Peppermint oil will be used for nausea/vomiting and lavender oil will be used for anxiety.~     This study will involve administration of aromatherapy to a convenience sample of patients,~     who will then be asked to complete a brief questionnaire. The questionnaire will involve a~     simple likert scale to measure efficacy (in the opinion of the patient) and simple~     multiple-choice questions to determine patients' likeliness to use aromatherapy again.~   "
107267|NCT02163356|"~     Currently there is no known effective treatment for recurrent or resistant neuroblastoma.~     Fenretinide is an anticancer agent that may work differently than standard chemotherapy. It~     may cause the buildup of wax-like substances in cancer cells called ceramides. In laboratory~     studies, it was found that if too much ceramide builds up in the neuroblastoma cells, they~     die.~      Fenretinide has been given by mouth as a capsule to many people, including children. When~     Fenretinide is given in capsules, very little of the drug is absorbed through the intestines~     into the body. This means patients have to take many capsules of fenretinide by mouth several~     times a day. In this study, a new oral preparation of fenretinide (called 4-HPR/LXS oral~     powder) is being tested to see if more fenretinide can be absorbed into the body. 4-HPR/LXS~     oral powder has been tested previously in a limited number of both children and adult cancer~     patients.~      Ketoconazole, commonly used to treat fungus infections, can increase fenretinide levels in~     the body by interfering with the body's ability to break down fenretinide. Ketoconazole will~     be given at the same time as the fenretinide powder.~      There is preclinical data that shows that combining fenretinide and vincristine prolonged~     survival in animal models, therefore, it is hoped that giving the vincristine with~     fenretinide will work better against the neuroblastoma that either drug given alone.~      About 70 children with neuroblastoma have been treated with various versions of the~     fenretinide powder to date, including about a dozen children that also took the fenretinide~     powder with ketoconazole, and no toxicities have occurred that limited the dosage and no~     serious or unexpected side effects occurred. However, vincristine has never been given with~     fenretinide or fenretinide plus ketoconazole before. Vincristine has been been given before~     with ketoconazole to both children and adults with neuroblastomas and other cancers.~   "
107268|NCT02163343|"~     Elevated serum metal ions are well recognized in metal-on-metal articulations in total hip~     replacements. The objective of the study is to see if the Cathcart / Corail device implanted~     during a hemiarthroplasty (replacement of one half of the hip joint) results in elevated~     serum metal ion levels (cobalt & chromium) and to see if there is an association between size~     of Cathcart head used and metal ion levels.~   "
107269|NCT02163330|"~     Normal pressure hydrocephalus (NPH) is an uncommon cause of dementia possibly reversible with~     treatment. First described in 1965 it consists of a triad of gait disturbance, cognitive~     deterioration, and urinary incontinence together with enlarged cerebral ventricles and normal~     cerebrospinal fluid (CSF) pressure. Foregoing trauma and hemorrhage, infection, mass lesions,~     or aqueductal stenosis can contribute to hydrocephalus. These symptomatic or secondary forms~     of NPH are not considered here and the focus lies on the idiopathic type (iNPH). Prevalence~     of iNPH increases significantly with age. General estimates range from 21.9 per 100,000 in~     total population surveys but increase up to 181.7 per 100,000 for people 70 to 79 years of~     age. The clinical presentation varies significantly in severity and progression of symptoms.~     For diagnosis the entire triad does not have to be present. In typical cases gait and balance~     disturbances appear either before or concurrently with urinary incontinence or the onset of~     dementia. Current treatment recommendations are based on surgical diversion of CSF , with~     shunts placed either into the ventricular system or the lumbar subarachnoid space to a distal~     site, such as the peritoneal or the pleural cavity or the venous system, where the CSF can be~     reabsorbed . Even though immediate response rate to shunt treatment might be favorable and~     rates of 80% responders have been reported , the perioperative and long-term morbidity and~     mortality of CSF shunting procedures are significant. A meta-analysis of 44 articles found~     that the pooled, mean rate of shunt complication was 38% . Even though acute surgical~     complication rates are low, shunt dysfunctions and long-term complications are relatively~     common. Shunt malfunction (20%), subdural hematoma (2-17%), seizure (3-11%), shunt infection~     (3-6%) and intracerebral hematoma (3%) are the most common complications . In those with good~     long-term survival, sustained improvement is possible, with a rate of 39% documented after 5~     years .In view of the complication rates, the lack of alternative treatment options and~     clinical studies is surprising. Even though iNPH per definition lacks raised intracranial~     pressure on spinal tap, monitoring of ICP prior to surgery reveals an increased amount of~     brief (usually 30 seconds to 1 minute) increases in the static ICP, called Lundberg B waves,~     in patients which improve by shunt placements . When patients are scheduled for shunt~     treatment there is a waiting period of several weeks between diagnosis and operation due to~     congested waiting list.~      Acetazolamide (Diamox) has been shown to reduce the production of CSF in clinical cases of~     raised intracranial pressure . It is considered the drug of choice for the treatment of~     idiopathic intracranial pressure (pseudotumor cerebri). Intuitively a connection between~     Acetazolamide as a treatment option in iNPH seems logical. Encouraging case studies have been~     published previously showing a fascinating improvement and success of treating iNPH with~     Acetazolamide. A systematic placebo controlled study concerning the use of Acetazolamide in~     iNPH is missing and would possibly pave the way to an alternative treatment option avoiding~     surgery and its complications.~   "
107270|NCT02163317|"~     This pilot clinical trial studies magnetic resonance (MRI)-guided focal stereotactic~     radiosurgery (SRS) in treating patients with low- or intermediate-risk localized prostate~     cancer. Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause~     less damage to normal tissue.~   "
107271|NCT02163304|"~     The primary purpose of this study is to quantify activation of regions of the brain~     associated with taste, appetite, and reward after viewing high sugar and high fat (HS/HF)~     images compared to control images following ingestion of (1) an artificially sweetened~     solution, (2) a sucrose solution, and (3) a tasteless control solution in normal weight vs.~     obese women. This is a repeated measures study design; hence, data are collected on three~     days corresponding to the three solutions. Body mass index (BMI) is a between subjects~     measure.~        1. After consuming an artificially sweetened solution and a sucrose solution compared to a~          tasteless solution, viewing HS/HF food images vs. control images will result in higher~          activation of taste pathways (frontal operulum and anterior insula (FO/AI)) in the~          brain.~        2. After consumption of a sucrose solution compared to an artificially sweetened solution~          and a tasteless solution, viewing HS/HF food images vs. control images will result in~          higher activation of regions of the brain associate with appetite (hypothalamus).~        3. After consumption of a sucrose solution compared to an artificially sweetened solution~          and a tasteless solution, viewing HS/HF food images vs. control images will result in~          higher activation of regions of the brain associated with reward [amygdala, anterior~          cingulate cortex (ACC), Orbitalfrontal Cortex (OFC), and ventral tegmental area (VTA),~          striatum, insula] in obese but not normal weight women. After consuming an artificially~          sweetened solution compared to a tasteless solution, viewing HS/HF images vs. control~          images will result in no differences in activation of reward pathways of the brain.~   "
107272|NCT02163291|"~     Gastric cancer is the second cause of cancer related death and China has the most gastric~     cancer patients in the world. Although systemic strategies, including adjuvant chemotherapy,~     postoperative chemoradiotherapy, perioperative chemotherapy, have evolved and showed benefits~     these years, the prognosis of advanced gastric cancer is still not satisfactory. Optimal~     regimens and optimal method administration is still being found. Neoadjuvant chemotherapy has~     many advantages, including downstaging the tumor, increasing R0 rate, early eradicating of~     micrometastasis. In previous trials, combination of paclitaxel and s-1 has showed safety and~     tolerance in recurrent or metastatic gastric cancer. Using liposome as a carrier, paclitaxel~     has a better histocompatibility and cellular affinity, resulting a improved stability and~     reduced toxicity. In this phase II trial, we are going to study the safety and feasibility of~     paclitaxel liposome plus s-1 as neoadjuvant chemotherapy.~   "
107273|NCT02163278|"~     The study is being performed to assess the safety, tolerability, and pharmacokinetic (PK) and~     pharmacodynamic (PD) properties of multiple oral doses of DBPR108 in healthy male subjects.~   "
107274|NCT02163265|"~     Pectus excavatum or carinatum are the most common congenital deformations of the ventral~     thoracic wall. Several different surgical methods with different techniques to correct these~     deformations have been described.~      Some clinicians recommend a correction of the deformation to improve the cardiopulmonary~     efficiency. Other think that the correction has a more an aesthetic than a physiological~     benefit.~      The aim of our prospective study is to evaluate whether patients with PE or PC are suffering~     preoperatively from a cardiopulmonary limitation at rest and under physical stress and if~     there is a change of cardiopulmonary function after the surgical correction.~   "
107275|NCT02163252|"~     The purpose of this study is to examine whether providing additional intervention support to~     individuals with lower than expected weight loss within the initial stages of an~     internet-based behavioral weight loss program improves weight loss outcomes at Week 12,~     compared to the internet program alone.~   "
107276|NCT02163239|"~     This study evaluates the use of the FloShield System with the FloShield 10mm reusable Cannula~     and Oburator during standard robotic laparoscopic single-site surgery. The study will~     evaluate the compatibility of the FloShield 10mm Cannula and Oburator with the daVinci®~     Robotic Surgical System during single-site laparoscopic surgery.~   "
107277|NCT02163226|"~     The goal of this clinical research study is to learn if 1 large dose of radiation therapy is~     better at controlling pain from cancer that has spread to the bones than 10 smaller doses of~     radiation. Researchers also want to learn if 1 large dose of radiation therapy can help~     decrease the use of drugs to control the pain, and if it can help to control the disease.~   "
107278|NCT02163213|"~     To evaluate the safety and effectiveness of oral nutritional therapy Serum-Derived Bovine~     Immunoglobulin (SBI) on nutritional status, epithelial barrier function, and mucosal~     expression of pivotal genes including tight junction, secretory mechanisms, tissue repair~     proteins and chemokines in subjects with IBS-D.~   "
107280|NCT02163187|"~     The purpose of this study is to evaluate whether a medical device/implant (InterStimTM) will~     help patients to have more normal bowel movements. The InterStimTM device is a~     neuromodulating device. Neuromodulation is a way of changing the activity of the nervous~     system by using electrical stimulation. InterStimTM is FDA approved to help people who have a~     hard time controlling their bowl movements. This is called fecal incontinence.The device is~     placed near a nerve root in the lower back. It works in a manner similar to a pacemaker by~     releasing electrical stimulation that triggers the S3 nerve root. When being placed, it is~     initially tested to make sure it will work using a temporary wire and then, if successful,~     the device is permanently implanted.~   "
107281|NCT02163174|"~     -  Hypothesis: The investigators hypothesized that Pentoxifylline has potent~          anti-inflammatory effect which can augment the antimicrobial effect of antibiotics in~          treatment of Late onset sepsis (LOS) in preterm infants thus decreasing neonatal~          mortality and morbidity.~        -  The purpose of this study: to assess the efficacy and safety of Pentoxifylline as an~          adjunct to antibiotic therapy on mortality and morbidity of preterm infants with LOS.~   "
107282|NCT02163161|"~     Phase 1, open label, single dose, 3 way crossover study to evaluate the bioavailability of a~     solid dose formulation of PF 04965842 relative to a suspension formulation under fasting~     conditions and the effect of food on the bioavailability of the solid dosage formulation of~     PF 04965842 in healthy subjects.~   "
107283|NCT02163148|"~     Anxiety disorders are common and impairing. Although exposure therapy is one of the most~     effective treatments for anxiety, some individuals do not fully respond to treatment, and~     these individual differences are not well understood. Exposure therapy involves repeated,~     deliberate, safe engagement with a feared stimulus without the feared outcome occurring. This~     treatment is thought to work through a type of emotional learning called fear extinction.~     This study aims to look at links between fear extinction learning and exposure success, with~     the overall goal of better understanding who is likely to respond best to exposure therapy~     and why.~   "
107284|NCT02163122|"~     This is a pilot trial in cat allergic participants, designed to compare allergic responses in~     each participant to a specific allergen by two methods of exposure. The methods of exposure~     to be used are: the environment exposure chamber (EEC) and nasal allergen challenge (NAC).~     Potential participants will be screened for evidence of cat allergy.~      Participants with a range of allergic sensitivities to cat allergen will be enrolled. To help~     ensure some breadth in the level of allergic sensitivity among participants, individuals with~     both high and low exposures to cat allergens in their daily lives will be enrolled.~   "
107285|NCT02163109|"~     Many serious illnesses are characterised by a lack of oxygen delivery to the body's tissues.~     This can be due to problems with the circulation, such as when the heart fails to pump blood~     efficiently or if the blood pressure is very low, or due to changes in the lungs preventing~     them from transferring oxygen effectively from the air into the blood.~      Many of the treatments used in critically ill patients are aimed at improving the supply of~     oxygen-rich blood to the tissues. These include drugs to increase the blood pressure or make~     the heart pump more forcibly, blood transfusions to increase the amount of oxygen that the~     blood can carry, and ventilators (breathing machines) to help the lungs introduce more oxygen~     into the bloodstream. Decisions to use such treatments are based on a number of factors. One~     of the most important is an assessment of how much oxygen an individual patient is using at a~     given time. Whilst it is possible to measure average oxygen consumption over a long period of~     time in healthy individuals, the equipment and techniques needed are simply not practical for~     routine use in the clinical setting of a critical care unit. Critical care doctors and nurses~     therefore have to rely on a number of different indicators of the adequacy of the amount of~     oxygen that is being provided in order to make decisions about how best to treat patients.~     Unfortunately, all of these have their limitations, are affected by other treatments patients~     may be receiving, and can be difficult to interpret. Examples include 'mixed venous oxygen~     saturation' (SvO2), that is the amount of oxygen in the blood coming back to the lungs from~     the body, ready to have more oxygen added, and blood lactate levels, which give an indication~     of whether the tissues have enough oxygen to produce the energy they need to function in an~     efficient manner.~      Our group has developed a device which can be added easily to the normal equipment used on a~     critical care ward when a patient is on a ventilator, which can accurately and rapidly~     measure the amount of oxygen the individual is consuming.~      This study will provide us with data so the investigators can define a normal range of~     oxygen consumption in these patients, and treatments which alter consumption. In a future~     study, once the investigators know what the normal range is, they can introduce new~     techniques to improve oxygen consumption in those patients whose consumption is less than~     ideal.~   "
107286|NCT02163096|"~     The purpose of this study is to assess benign joint hypermobility syndrome (BJHS) in children~     with a history of wheezing or asthma. BJHS is a common syndrome of joint and connective~     tissue laxity without any other rheumatologic disease. This assessment will be performed by~     using either method below depending upon if the child has a history of wheezing or severe~     asthma:~        1. Determine the correlation, if there is an increased rate of BJHS in children with a~          history of wheezing as well as if there is an increased history of wheezing in children~          with BJHS; or~        2. Determine asthma control, lung function and asthma exacerbations (a flare up or acute~          worsening of symptoms) in children with BJHS compared to children with asthma without~          BJHS, to assess if it BJHS is associated more with children with severe asthma.~   "
107287|NCT02163083|"~     The purpose of this study is to investigate, whether the detection of lymph nodes by means of~     intraoperative fluorescence lymphography as part of lymphadenectomy in robot-assisted radical~     prostatectomy is higher than without the use of indocyanine green (ICG).~   "
107288|NCT02163070|"~     The purpose of the study is to evaluate the effect of vitamin E fortified whey drink on~     nutritional status, inflammatory markers and oxidative stress in hemodialysis patients~   "
107289|NCT02163057|"~     This is a Phase I/IIa, open-label study to evaluate the safety, tolerability, and~     immunogenicity of INO-3112 DNA vaccine delivered by Electroporation to subjects with HPV~     associated head and neck squamous cell cancer.~   "
107299|NCT02162927|"~     In the past, dietary nitrate supplementation has been shown to have clinical benefits in the~     treatment of cardiovascular issues. More recently, however, the focus of nitrate~     supplementation has shifted to focus of human performance, and has shown to increase the time~     to exhaustion during maximal intensity exercise and lower the cost of oxygen consumption~     during submaximal intensity exercise. Acutely, nitrate supplementation in the form of~     beetroot juice has been shown to increase strength measurements, as well as increase the time~     to complete a 2000 meter rowing ergometer test. However, to the author's knowledge, there are~     no studies that link the relationship between multi-day nitrate supplementation and the~     rowing test or the nitrate's effect on strength when in the salt form. Additionally, to the~     author's knowledge, no evidence has been published which relates dietary nitrate~     supplementation and its effects on a CrossFit circuit workout.~      Our central hypothesis is that six days of dietary nitrate supplementation will improve~     strength, endurance, a power more than a placebo in male CrossFit athletes.~   "
107290|NCT02163044|"~     Coronary heart disease (CHD) is the leading cause of death worldwide. The disease is~     characterized by a high mortality rate (about 40%) and a course continuously altered by~     lifestyle, gene polymorphisms and therapeutic treatment. Fasting concentration of blood~     lipids and lipoproteins only partially express the complex relation between dyslipidemia and~     CHD. Following the indication stated nearly 40 years ago by Zilversmit, there is now~     accumulating evidence that postprandial lipemia plays an important role in the atherogenic~     process [ref Kolovou], particularly that most hours of the day are spent in the postprandial~     state. Furthermore, the increases in blood glucose and triglycerides (TGs) following meals~     stimulate oxidative stress, impair endothelial function, and rises the inflammatory factors~     that lead to atherosclerosis. Previous studies reported on postprandial lipemia in subjects~     with obesity, metabolic syndrome, diabetes mellitus, elderly, patients with CHD and others.~     However, currently the estimation of cardiovascular disease risk is based on fasting blood~     values of triglycerides (TGs) and inflammatory markers. The effect of postprandial~     atherogenic factors on the initiation and progression of atherosclerosis is actually not~     known.The Hellenic Postprandial Lipemia Study (HPLS) was designed to study the consequences~     of postprandial lipemia in CRP as inflammatory marker in high-risk adults. Furthermore, the~     HPLS study will investigate whether hypolipidemic, hypoglycemic or antihypertensive~     medication may lessen the exaggerated postprandial lipemia as well as the rest abnormal~     postprandial metabolism. Finally, the HPLS study is intending to evaluate the influence of~     gene polymorphisms involved in lipid and glucose metabolism on postprandial lipemia and~     cardiovascular outcomes.~   "
107291|NCT02163031|"~     Orthotopic heart transplantation is a well established therapeutic measure for end stage~     heart failure, leading to significant improvements in survival and quality of life. In the~     routine clinical practice, orthotopic heart transplantation patients receive periodic cardiac~     catheterization for early detection of allograft vascular disease.~      The coronary angiography of these patients is characterized for several technical~     difficulties, generally related to the presence of the aortotomy with anomalous implantation~     of the coronary ostia and to the orthotopic position of the allograft. For these reasons,~     trans femoral approach is usually preferred. In the last two decades, trans radial approach~     for coronary angiography emerged to be effective, safe and able to improve patient comfort.~     However, there is no universal consensus on the optimal choice of radial access from either~     the left or the right artery. Currently, this choice is largely dependent on the operator's~     preference. The trans right radial approach is generally preferred in routine clinical~     practice mainly due to its easier catheter manipulation for the operators from patient's~     right side, and the current design of radial compression devices for the right wrist in~     medical market. As such, a major barrier to prevent the wide adoption of the left radial~     access lies in some difficulty to reach the left wrist leaning over the patient, particularly~     for shorter operators or in obese patients. However, a great deal of attention has been~     recently directed toward the trans left radial access, as it has an important anatomical~     advantage due to the vascular anatomy of epiaortic vessels with a straighter route to the~     left coronary ostium, which could also reduce the risk of cerebrovascular complications.~      However, no data are available about the performance of trans left radial or trans-right~     radial approach in coronary angiography orthotopic heart transplantation patients. However,~     in this particular setting of patients, the left radial approach might reduce the technical~     difficulties related to the anatomical variations.~      In this single centre, prospective, randomized study, we sought to compare trans right radial~     versus trans left radial approach in terms of amount of contrast medium, radiation exposure,~     number of catheters used, cross over to the other access site rate and local and systemic~     complications in orthotopic heart transplantation patients.~   "
107292|NCT02163018|"~     Currently, there is no effective causal treatment for peanut allergy. A chemically modified,~     aluminium hydroxide adsorbed peanut extract (HAL-MPE1) for subcutaneous administration has~     been developed. Results from in vitro and in vivo preclinical studies demonstrate the~     immunotherapeutic potential of HAL-MPE1. Therefore, a phase I, single-centre clinical trial~     has been designed to assess the safety and tolerability of HAL-MPE1 in peanut allergic~     patients.~   "
107293|NCT02163005|"~     Patients with an allergy to iodine based intravenous contrast cannot undergo a CT scan with~     contrast, unless they are premedicated. Premedication can result in a delay in diagnosis,~     that can be significant with acute conditions such as Pulmonary embolism.~      The investigators are evaluating the use of Gadolinium as an alternative contrast agent in~     CT. Gadolinium has been used extensively in MRI exams but the dose that is used is not~     sufficient to provide good enhancement on CT. Dual Energy CT is a new technology that has~     better sensitivity to lower doses of intravenous contrast and the investigators aim to study~     its effectiveness in improving the enhancement with Gadolinium. The investigators will~     compare enhancement of Iodine with enhancement of Gadolinium during Dual Energy CT, to assess~     the possibility that Gadolinium could be used as an alternative for patients who are~     suspected of having Pulmonary embolism. They will recruit up to 50 patients who are having a~     routine Chest CT during treatment for a malignancy and administer Gadolinium contrast and~     Iodine contrast during a chest CT exam. The enhancement with the two agents can be compared.~   "
107294|NCT02162992|"~     Connective tissue diseases have been related to heart conduction disorders. The anti-Ro/SSA~     antibodies are thought to have a pathogenic role, and they most prevalent in systemic lupus~     erythematous (SLE). The aim of this study is to evaluate the relationship between SLE,~     arrhythmias and its serologic profile.~   "
107295|NCT02162979|"~     This study is to determine if Viagra is effective in reducing dyskinesias in patients with~     Parkinson's Disease.~   "
107296|NCT02162966|"~     Colistin is a rapidly acting bactericidal antimicrobial agent that possesses a post~     antibiotic effect against MDRO Gram-negative bacteria, such as as Pseudomonas aeruginosa,~     Acinetobacterbaumannii, and Klebsiella pneumonia.~   "
107297|NCT02162953|"~     Background: Autosomal recessive bestrophinopathy (ARB) is one of 5 blinding eye diseases~     caused by mutations in the gene BEST1. These diseases, collectively termed~     bestrophinopathies include ARB, Best vitelliform macular dystrophy (BVMD), adult-onset~     vitelliform dystrophy (AVMD), autosomal dominant vitreoretinalchoroidopathy (ADVIRC) and~     retinitis pigmentosa (RP) .~      Objective: To collect DNA/RNA and skin samples from individuals with ARB or other diseases~     due to mutations in the gene BEST1. These models will be used to identify and test~     therapeutic approaches to treating these diseases.~      Design: Study involves a one time donation of a skin punch biopsy and whole blood. Once the~     skin biopsy is obtained, skin fibroblasts will be isolated, which will be reprogrammed into~     iPSCs. RPE cells will be derived from the iPSCs~   "
107298|NCT02162940|"~     The impact of statin use on response to epidural steroid injections remains unknown and may~     well increase the effect considering the substantial anti-inflammatory properties. We thus~     tested the primary hypothesis that patients taking statins before and after the procedure~     will have lower VAS scores compared to patients not on statins. Secondarily we tested the~     hypothesis that statin users will have improved quality of life evaluated with Short Form 36~     (SF 36).~   "
108739|NCT02144155|"~     The Objective of this study is to investigate the long-term efficacy of intranasal oxytocin~     in improvement of symptoms in patients with schizophrenia who have residual symptoms dispute~     being on adequate treatment with antipsychotic medication.~   "
107300|NCT02162914|"~     The study is a multicenter randomized (1:1) placebo-controlled, double-blinded phase II trial~     aiming to demonstrate an improvement of median PFS when treating locally advanced~     unresectable or metastatic patients suffering from an intra-hepatic or hilum (mass-forming)~     cholangiocarcinoma with Regorafenib as compared to placebo, and after progression after~     GEM-CDDP (or GEM-OX), or gemcitabine alone followed or preceded by platinum (CDDP or~     oxaliplatin)-based chemotherapy.~      The principal objective is to investigate Regorafenib efficacy by prospectively evaluating~     the PFS after the administration of Regorafenib combined with BSC as compared to placebo with~     BSC. Hypothesis is a 50% improvement in median PFS (from 6 weeks to 12 weeks in Regorafenib~     group).~   "
107301|NCT02162901|"~     The aim of this project is to evaluate the reach, effectiveness, and costs of two~     patient-centered, theory-based, technology-enhanced diabetes prevention programs to initiate~     and sustain weight loss among pre-diabetic adults (i.e. impaired fasting glucose or impaired~     glucose tolerance) within a health care setting. The overall aim is consistent with the~     NIDDK's Behavioral/Prevention Research Program's focus on individual, family, and~     community-based strategies for prevention of diabetes and its complications. While evidence~     of lifestyle interventions that increase physical activity and improve eating habits to~     achieve modest weight loss in delaying and preventing the onset of type 2 diabetes continues~     to mount, the translation of these interventions into effective programs to health care~     settings with modest resources remains a challenge. The proposed research project will~     conduct a pragmatic clinical trial that employs a hybrid Preference/Randomized Controlled~     Trial (RCT) designed to compare two technology-enhanced diabetes prevention programs in~     achieving objectively verified weight loss relative to a standard care control at~     comparatively lower costs. Adult patients (18 years of age and older) at risk for developing~     diabetes will be randomized to either the Choice group or the Randomization group. Those~     patients randomized to the Choice group (n=240) will have the opportunity to choose one of~     two programs to participate in: 1. A 2-hour Small-Group (SG) session, with automated~     interactive voice response (IVR) systems targeting personal action planning to support~     lifestyle change and weight loss over a period of 12 months; or 2. A DVD-based intervention~     with the same IVR follow-up. Those patients assigned to the RCT group (n=360) will be~     randomized to one of three groups: 1. SG/IVR; 2. DVD/IVR; or 3. Enhanced standard-care (SC).~     SC includes the referral to a currently offered pre-diabetes class. Primary outcome measures~     include weight loss, cost, and reach of each program. Secondary outcome measures include~     physical activity behavior; eating behavior; and process evaluation. It is hypothesized that~     both the SG/IVR and the DVD/IVR interventions will produce significantly greater amounts of~     weight loss at 6, 12, and 18 months following program initiation than SC but will not differ~     from one another. The investigators also hypothesize that the DVD/IVR will have broader reach~     and may be more cost-effective than SG/IVR or SC.~   "
107302|NCT02162888|"~     The purpose of this study is to demonstrate that a new formulation of an Bendamustine (BDM)~     Hydrochloride (HCl) is bioequivalent (BE) (similar) to the commercially available product in~     patients with cancer.~   "
107303|NCT02162875|"~     The objective of this study is to determine the strategy for mass drug administration (MDA)~     which provides the greatest reductions in prevalence and intensity of Schistosoma mansoni in~     school-aged children after 4 years of intervention.~   "
107304|NCT02162862|"~     The purpose of this study is to determine if either a targeted type of talk therapy (Phase I)~     or medication, Wellbutrin, (Phase II) improve sleep disturbance and/or fatigue in individuals~     with Inflammatory Bowel Disease (IBD).~   "
107305|NCT02162849|"~     The goal of this clinical research study is learn if varenicline or the nicotine patch can~     help people with different types of emotion and attention levels to quit smoking.~   "
107306|NCT02162836|"~     The purpose of this study is to evaluate the safety and tolerability of JNJ-56021927 in~     Japanese participants with metastatic castration-resistant prostate cancer (mCRPC- prostate~     cancer that is resistant to medical [for example. hormonal] or surgical treatments).~   "
107307|NCT02162823|"~     SPP study includes incidence cases of pancreatic cancer in the Stockholm county region from~     2007 to 2014. The purpose of SPP study is to estimate relative risk of pancreatic cancer in~     relation to snuff dipping, overweight/obesity, individual food items, food groups, dietary~     pattern and various nutrients; to estimate relative risk of pancreatic cancer in relation to~     exposure to nitrosamines, either endogenously or exogenously; to estimate relative risk of~     pancreatic cancer in relation to oral health and H.pylori infection and their interaction~     with ABO blood type; to estimation relative risk of pancreatic cancer in relation to~     hepatitis B or hepatitis C infection; to estimate relative risk of pancreatic cancer in~     relation to some genetic polymorphisms, either functional or being suggested in GWAS study;~     to estimate mutation profile in pancreatic cancer cases, and its correlation with~     environmental exposures, and the impacts on survival periods in pancreatic cancer patients.~      The MeSH name is Carcinoma, Pancreatic Ductal~   "
107308|NCT02162810|"~     The primary objective of this study is to determine the efficacy of administering a course of~     postoperative oral steroids in pediatric patients undergoing proximal hypospadias repair as~     prevention against complications. Specifically, the study aims to assess if the steroids i)~     decrease the incidence of wound breakdown, fistula formation, stenosis or stricture~     formation, and the need for subsequent redo-hypospadias surgeries and/or fistula repairs and~     ii) improve the quality of wound healing including the overall cosmetic appearance of the~     phallus (i.e. location of the urethral meatus).~   "
107309|NCT02162797|"~     INTRODUCTION:~      An adequate zinc supplementation is essential for a good immunological function. However,~     zinc deficiency is seen in more than 50% of adults infected with HIV. The safety and~     efficiency of zinc supplements in the progression of HIV is evaluated in the short-term.~      HYPOTHESIS~      Null hypothesis: Zinc supplementation does not improve the immunological recovery of HIV~     patients after three months of daily consumption.~      Alternate hypothesis: Zinc supplementation improves the immunological recovery of HIV~     patients after three months of daily consumption~   "
107310|NCT02162784|"~     The objective of the study is to evaluate the dose response of SYN006 HFA MDI, which is a~     combination drug product of budesonide and procaterol hydrochloride, in asthma patients.~     Patients with mild to moderate asthma will be recruited. There will be two study medication~     administered in this study. The investigational medication is SYN006 (Budesonide/Procaterol~     hydrochloride, 180 mcg/10 mcg per inhalation) and the active comparative medication is~     Ventolin (Salbutamol sulfate 100 mcg per inhalation). The study medication will be~     administered by oral inhalation with the supervision of the investigator or a qualified~     staff.~   "
107311|NCT02162771|"~     This study is a Phase 3 prospective, randomised, parallel-group, active controlled, double~     blind, multicentre, international study with 2 coprimary endpoints designed to demonstrate~     equivalence in pharmacokinetics (Part 1), as well as noninferiority in efficacy (Part 2), of~     CT-P10 to Rituxan when coadministered with CVP and to assess efficacy and safety in patients~     with advanced (stage III-IV) FL. Part 1 and Part 2 of the study will run in parallel.~   "
139568|NCT01740505|"~     This study will compare three different exercise programs in older adults who report~     difficulty walking and will determine if the programs improve walking.~   "
107313|NCT02162745|"~     Bronchiolitis is a leading cause of acute illness and hospitalization in the first year of~     life. Most children with bronchiolitis have mild disease and are managed at home with support~     from primary care providers, while children with more severe symptoms require supportive~     therapy with oxygen and fluid administration.~      Neonates may be obligate nasal breathers until they are at least 2 months old and nasal~     obstruction may play a relevant role in respiratory resistances throughout the first months~     of life, whereas nasal passages may exhibit as much as 50% of the total airway resistance.~     Some guidelines recommend to clear the nostrils of secretions to improve airway patency but~     no controlled trial on the efficacy of nasal irrigation in infants with bronchiolitis was~     carried out.~      The aim of this randomized controlled trial is to compare normal saline and hypertonic~     solution for nasal irrigation versus simple supportive care in infants admitted to Emergency~     Department with bronchiolitis and mild desaturation.~   "
107314|NCT02162732|"~     The purpose of this study is to test the feasibility (ability to be done) of experimental~     technologies to determine a tumor's molecular makeup. This technology includes a genomic~     report based on DNA exomes and RNA sequencing that will be used to discover new ways to~     understand cancers and potentially predict the best treatments for patients with cancer in~     the future.~   "
107315|NCT02162719|"~     This multicenter, randomized, double-blind study will estimate the efficacy, safety and~     tolerability of ipatasertib combined with paclitaxel compared with placebo combined with~     paclitaxel in participants with inoperable locally advanced or metastatic triple-negative~     breast cancer (mTNBC), as measured by progression-free survival (PFS) in all participants and~     in participants with phosphatase and tensin homolog (PTEN)-low tumors.~   "
107316|NCT02162706|"~     Cortisol is a hormone critical for survival in times of stress. Currently most measurements~     are done with blood samples. The hypothesis of this study is cortisol measured from saliva~     using mass spectrometry can be used to replace measurements by blood.~   "
107317|NCT02162693|"~     Current medication treatments for KOA aim to relieve inflammation and pain, but they do~     little to delay or reverse the disease progression and most medications have obvious side~     effects. When the conservative treatments are useless to patients and joint deformities and~     joint disfunction, the patients may require surgery. Although surgery of the joints can~     relieve the pain temporarily, long-term effect (over 10 years) is hard to achieve.~   "
107318|NCT02162680|"~     The purpose of this study is to compare how well different anesthetic, or numbing, solutions~     injected under the skin work in reducing the discomfort associated with placing a catheter in~     a vein. Two different medications, lidocaine and normal saline with benzyl alcohol, have been~     found to be effective in reducing discomfort when injected under the skin just prior to~     inserting the catheter. This study compares these two solutions, and will compare the~     discomfort that occurs both with and without using these solutions.~   "
107319|NCT02162667|"~     This study will determine whether CT-P6 and Herceptin are equivalent in patients with~     early-stage breast cancer undergoing neoadjuvant chemotherapy. Our hypothesis is that the~     pathologic complete response rate will be equivalent in patients treated with neoadjuvant~     CT-P6 or Herceptin. Patients will receive 8 cycles of neoadjuvant systemic therapy and up to~     10 cycles of therapy in the adjuvant setting.~   "
107320|NCT02162654|"~     The RIPAT study is a prospective, randomized, double-blind study organized by the~     neurovascular group of the Clinical Department of Neurosurgery of Innsbruck Medical~     University, Innsbruck, Austria. Patients aged 18+ in whom the treatment of an un-ruptured~     intracranial aneurysm is indicated are eligible for study participation. Prior to aneurysm~     treatment, with the patient already under general anesthesia, the blood supply to an arm will~     be restricted for 3x 5minutes by inflating a standard blood pressure cuff. The study~     hypothesis is that this remote ischemic preconditioning maneuver is able to prevent a~     stroke during the following treatment of the aneurysm.~   "
107321|NCT02162641|"~     The purpose of this study is assess the technical and operational feasibility of a~     specialised biopsy technique, sentinel lymph node biopsy (SLNB), in patients with anal~     cancer.~   "
107322|NCT02162628|"~     The purpose of this study is to compare safety and effectiveness of the Exair Prolapse Repair~     System for treatment of pelvic organ prolapse to traditional native tissue repair through 36~     months of follow-up.~   "
107323|NCT02162615|"~     The purpose of this study is to collect information on the safety and effectiveness of~     Restorelle Direct Fix mesh and the surgical procedure to implant Restorelle. These results~     will be compared to the safety and effectiveness results in patients who have native tissue~     repair (without mesh) as their pelvic organ prolapse treatment.~   "
107324|NCT02162602|"~     Compromised bone strength and increased fracture susceptibility pose significant morbidity~     and health care costs in children. Inadequate childhood bone accretion also may have lifelong~     consequences. Bone fragility among children with chronic medical conditions is a special~     concern. Identifying children at-risk for bone fragility and factors affecting bone strength~     requires understanding normal bone development. Dual energy x-ray absorptiometry (DXA) is the~     most common method for measuring bone mineral content and bone density in children. There are~     bone density reference data for children ages 5-20 years. An important gap is the lack of~     reference data for children ages < 5 years, who also experience numerous medical conditions~     that threaten their bone health.~      Growth and body composition influence bone mineral accrual, and are important for~     interpreting bone density measurements in children with conditions that threaten bone health.~     Gross motor skills and subsequent physical activity may also affect bone accrual. Children~     with chronic illness are at risk of altered body composition, delayed growth and gross motor~     skills, and restricted physical activity. Understanding independent effects of growth, body~     composition, gross motor skills and physical activity on bone accrual will improve~     interpretation of bone density measurements and has important research and clinical~     applications for identifying risk factors and therapies for young children.~      This study will involve a longitudinal cohort of 280 children studied every 6 months for 3~     years, and a cross-sectional cohort of 240 children measured once. The study will be~     conducted at 2 clinical centers [Cincinnati Children's Hospital Medical Center (CCHMC) and~     the Children's Hospital of Philadelphia (CHOP)] with equal enrollment at both centers.~     Measurements will include bone density, growth and body composition, dietary intake, sleep,~     physical activity and gross motor skills. Results from this study will enable clinical bone~     health assessment of young children with disorders that threaten bone health, and identify~     factors that affect bone accrual.~   "
107325|NCT02162589|"~     Prospective Multicenter registry study to assess the safety and efficacy of clinically~     indicated peroral endoscopic myotomy (POEM) for the treatment of Achalasia~   "
107338|NCT02162420|"~     Fludarabine-based preparative regimen followed by an allogeneic hematopoietic stem cell~     transplant using related or unrelated donor in persons 0-70 years of age diagnosed with~     dyskeratosis congenita or severe aplastic anemia who have bone marrow failure characterized~     by a requirement for red blood cell and platelet transfusions. Three different preparative~     regimens are included based on disease and donor type.~   "
140106|NCT01733472|"~     The purpose of this study is to determine whether general anaesthesia or regional anaesthesia~     is best for patients undergoing Total Hip Arthroplasty.~   "
107326|NCT02162576|"~     Propeller Health is collaborating with the City of Louisville and other local partners to~     carry out a focused demonstration project that will evaluate the effectiveness of the~     Propeller Health approach to asthma management while exploring means to use real-time data on~     asthma exacerbations in a public health setting. The Asthma Data Innovation Demonstration~     Project (ADID) will use wireless sensor technology to develop spatial and temporal data on~     the use of rescue inhalers by 120 study subjects with asthma in the Louisville metropolitan~     area. Propeller Health will process these data to support two general strategies.~      Asthma self management: Rescue inhaler actuation data will be compiled into individualized~     feedback reports to support asthma self management. Propeller Health will combine information~     on individual rescue inhaler actuations with evidence-based asthma management tips into~     real-time reports that will be provided to subjects. ADID staff will evaluate any resulting~     improvements in asthma control that may be based on this information. Subjects may share~     reports with their healthcare providers.~      Municipal purposes: The second strategy is to provide aggregated and de-identified, spatial~     and temporal asthma rescue inhaler actuation data to City personnel and authorized public~     health researchers in Louisville. These data will show the times and locations of the use of~     rescue inhalers by the 120 study subjects throughout the greater Louisville area. ADID staff~     will work with City personnel and researchers to investigate how this unprecedented level of~     detailed information on exacerbations can be used best to increase public awareness of~     environmental triggers while supporting public health surveillance efforts around respiratory~     diseases.~   "
107327|NCT02162563|"~     Colorectal cancer patients with initially unresectable liver-only metastases may be cured~     after downsizing of metastases by neoadjuvant systemic therapy. However, the optimal~     neoadjuvant induction regimen has not been defined, and no consensus exist on criteria for~     resectability.~      In this study colorectal cancer patients with initially unresectable liver-only metastases,~     as prospectively confirmed by an expert panel according to predefined criteria, will be~     tested for RAS and BRAF tumor mutation status and selected by location of primary tumor.~     Patients with RAS or BRAF mutant and/or right sided tumors will be randomised between doublet~     chemotherapy (FOLFOX or FOLFIRI) plus bevacizumab (schedule 1), and triple chemotherapy~     (FOLFOXIRI) plus bevacizumab (schedule 2). Patients with RAS AND BRAF wildtype AND left-sided~     primary tumors will be randomized between doublet chemotherapy (FOLFOX or FOLFIRI) plus~     either bevacizumab (schedule 1) or panitumumab (schedule 3). Patient imaging will be reviewed~     for resectability by a central panel, consisting of at least one radiologist and three~     surgeons every assessment. Central panel review will be performed prior to randomization as~     well as during treatment, as described in the protocol.~   "
107328|NCT02162550|"~     Investigators will be determining whether a once weekly injectable medication Bydureon versus~     placebo is able to reduce the development of atherosclerosis.~      Investigators are testing the overall hypothesis that 18 months of Bydureon treatment will~     improve cardiovascular risk factors, endothelial function and retard carotid atherosclerosis~     plaque progression in type 2 diabetes mellitus (T2DM). Investigators anticipate these studies~     will provide novel information about the temporal relationship between Bydureon induced~     changes in risk factors, endothelial function and atherosclerosis progression.~   "
107329|NCT02162537|"~     The patients carrying a complicated primary lung cancer brain metastases die in less than 3~     months of delay disease in the absence of treatment. The median survival of these patients is~     approximately six months when the treatment associated with radiotherapy chemotherapy based~     on cisplatin is now the standard treatment. In most studies the patients die of their brain~     disease in one case only two, so it is likely that some patients do not require brain~     irradiation (prognosis in this case is linked to extra-cerebral disease ). The benefits for~     patients in group B (without systematic irradiation) are not to suffer the side effects of~     this radiation. The risks are in the same group to see brain metastases become symptomatic.~      The role of cerebral radiotherapy in the patients treated with chemotherapy is unclear:~     should all patients be irradiated systematically (since the reference treatment is involved~     and with the aim of obtaining better control of the brain lesions and maintaining a better~     neurological status) or should only the patients showing cerebral progression be irradiated~     (avoidance of possibly useless brain radiotherapy and its side effects). The aim of this~     study is to better determine the position of cerebral radiotherapy in this context.~      Main objective:~      determine whether there is a difference in terms of progression-free survival between a~     therapeutic strategy with initial systematic brain radiotherapy followed by chemotherapy~     cis-platine/alimta + / - Bevacizumab and strategy with an initial chemotherapy~     cis-platine/alimta + / - Bevacizumab associated with brain radiotherapy only in cases of~     cerebral progression in patients with NSCLC with asymptomatic brain metastases~   "
107330|NCT02162524|"~     The primary purpose of this study is to quantify activation of regions of the brain~     associated with appetite and reward after viewing high sugar and high fat (HS/HF) images~     compared to control images following long-term aerobic exercise.~        1. After long-term aerobic exercise compared to a no-exercise control group, viewing HS/HF~          food images vs. control images will result in higher activation of regions of the brain~          associate with appetite (hypothalamus).~        2. After long-term aerobic exercise compared to a no-exercise control group consumption of~          a sucrose solution compared to an artificially sweetened solution and a tasteless~          solution, viewing HS/HF food images vs. control images will result in lower activation~          of regions of the brain associated with reward [amygdala, anterior cingulate cortex~          (ACC), Orbitalfrontal Cortex (OFC), and ventral tegmental area (VTA), striatum, insula]~          in overweight and obese men and women.~      Exploratory Aims As exploratory aims, investigators will test a preliminary brain~     connectivity analysis.~   "
107331|NCT02162511|"~     The purpose of this protocol is to provide access to the CliniMACS® System to hematopoietic~     cell transplant (HSCT) patients who do not have a matched related donor. The CliniMACS system~     is currently approved for use in patients who have AML, and a genetically matched sibling~     donor. Through this protocol, the investigators will be able to offer potentially life-saving~     transplants to patients who have genetically mis-matched donor, who have no other options for~     treatment.~   "
107332|NCT02162498|"~     The 2010 revised WHO recommendations to provide antiretroviral (ARV) prophylaxis or treatment~     to mothers or infants during the breastfeeding period indicate a paradigm shift in prevention~     of mother-to-child transmission (PMTCT); care; and treatment programming. Yet despite South~     Africa's adoption of this guidance, myriad challenges currently exist. Confusion in the~     public health care system related to mixed messaging around safe infant feeding and the~     provision of—and now withdrawal of—free formula milk have made adherence to exclusive~     breastfeeding a challenge in South Africa. Cultural, social, and psychological factors~     influence the ability of women to follow PMTCT guidelines, which include exclusive~     breastfeeding for six months, adherence to ARV prophylaxis or treatment, and early infant~     diagnosis. Facility-based interventions alone are often inadequate to effect sustained~     behavioral changes in the face of multiple contextual factors. Community- and home-based~     support are needed, yet cost and systems constraints make these infeasible in many PMTCT~     programs. Some preliminary pilot data suggests that a feeding buddy strategy could fill this~     gap and provide a home-based support system for the mother. The feeding buddy, who is~     selected by an HIV-positive pregnant woman to support her in overcoming sociocultural~     challenges to adhering to various aspects of PMTCT programs, is not an employed health care~     worker, but rather an individual known to the mother, making the intervention extremely~     cost-effective, and requiring minimal resources to implement. In the Uthungulu District of~     KZN the Programme for Appropriate Technologies in Health (PATH) is implementing a programme~     (Window of Opportunity-WinOp) of improving health of mothers and infants, and the feeding~     buddy strategy is one of the strategies included in this overall package of care. While this~     strategy has been encouraged by the South African Department of Health, it has not previously~     been implemented nor obviously evaluated. In order to scale-up such a programme and justify~     the human resource costs, it is vital that such a programme be evaluated.~      The goal of this proposed research study is therefore to evaluate the effect of the feeding~     buddy strategy to support mothers to adhere to PMTCT recommendations.~      The investigators hypothesize that mothers who choose a feeding buddy will have increased~     rates of exclusive breastfeeding and adherence to ARV prophylaxis or treatment, as well as~     improved rates of early infant diagnosis and stigma reduction.~      This evaluation will provide valuable information to the Department of Health in terms of~     choosing best practice models for promoting HIV-free infant survival and optimum health of~     infants in resource limited settings. The project plans to employ a cluster randomized~     intervention design and will include 300 mothers and their infants as well as the 300 buddies~     in the intervention group, as well as 300 mothers in the control group. All participants will~     be part of the WinOp feeding buddy intervention programme.~   "
107333|NCT02162485|"~     The purposes of this study is to compare the test products Salmeterol/fluticasone Easyhaler~     with marketed product Seretide Diskus in terms of the drug absorbed into the blood stream~   "
107340|NCT02162394|"~     The investigators are conducting a prospective, observational study to examine the ECG~     waveforms captured by the new medical device as compared to a traditional Holter monitor for~     subsequent use in visual diagnoses of atrial and ventricular arrhythmias as well as cardiac~     impulse and/or conduction disorders by qualified clinicians.~      The hypothesis is that this new medical device prototype is non-inferior to traditional~     Holter monitoring for capturing ECG waveforms that can be visually assessed for atrial and~     ventricular arrhythmias as well as disorders of cardiac impulse formation and/or conduction.~   "
107341|NCT02162381|"~     Study will include adults with abnormal visual fields. Half of them will be given either~     methylphenidate 10mg 2 hours before repeating the visual field test. the rest will serve as~     controls. All Subjects will also have a complete eye examination, a short questionnaire and a~     questionnaire to screen for attention deficit disorder. The investigators will compare the~     visual field results between the 2 tests.~   "
107342|NCT02162368|"~     Spine surgery is the most common procedure in neurosurgical setting. Some centers have chosen~     the patient self-position to avoid complications such as accidental extubation or loss of the~     iv line. The aim of our retrospective study is to describe our experience in the laryngeal~     mask use for airway management in patient submitted to spine surgery in neurosurgery~   "
107343|NCT02162355|"~     The purpose of this multiple ascending dose study is to characterize the safety,~     tolerability, and the amount of GLPG0634 present in the blood and urine (pharmacokinetics) of~     once daily oral administrations of GLPG0634 at 3 different dose levels for 10 days in~     Japanese healthy subjects.~      Furthermore, the study will compare the safety, tolerability, pharmacokinetics, and effects~     of GLPG0634 on mechanism of action-related parameters in the blood (pharmacodynamics) of once~     daily oral administrations of GLPG0634 given at one dose level for 10 days in Japanese vs~     Caucasian healthy subjects.~   "
107344|NCT02162342|"~     The subjet is sitting on a chair and in front of him an adjustable (height) table with a~     glass of water. 17 passive reflective markers are placed on his upper extremities and torso.~     The subject is requested to reach the glass (once with the right hand and then with the left~     hand) and bring it to the mouth and drink. Then the subject put the glass back at the~     starting position. This is performed twice for each hand. In the second part, the same trial~     is repeated but muscle activity is recorded with surface electromyography.~   "
107345|NCT02162329|"~     The goal of this research study is to test Tibetan meditation as a therapy to teach cancer~     patients to change their brain functioning and to improve quality of life. Researchers want~     to compare the cancer patients' outcomes to people who have never had cancer.~   "
107346|NCT02162316|"~     This is a clinical study to evaluate the efficacy between Helicobacter pylori Eradication~     therapy and Motilitone in Functional Dyspepsia~   "
107347|NCT02162303|"~     The purpose of this trial is to assess the effects of colchicine on vascular inflammation~     measured by (FDG)-PET imaging in patients with atherosclerotic vascular disease. This effect~     will also be measured by soluble plasma biomarkers. Finally, an optional pharmacogenomic~     investigation will be performed to identify genetic biomarkers of patient response.~   "
107348|NCT02162290|"~     The research will study the differences between interval training and continuous training~     among cardiac patients in a cardiac rehabilitation facility.~      The main objectives are:~        1. Functional capacity measures (VO2 max).~        2. Cardiac risk factors~        3. Quality of life assessments.~      Study hypothesis:~      Interval training will be more effective in improving functional capacity, cardiac risk~     factors and quality of life, compared to continuous training.~   "
107349|NCT02162277|"~     The frequency of osteoporosis in Japan is increasing. Also, the frequency of~     osteoporosis-based fractures in postmenopausal women is increasing. Therefore, it is urgently~     required to improve osteoporosis. Life expectancy in Nagano prefecture is the longest in~     Japan, however, healthy life expectancy in Nagano is not very long in Japan. There are~     several problems in this issue from the medical site and the patient site. The aim of this~     study is, from the patient site, to increase the motivation of postmenopausal women for~     osteoporosis using osteoporotic diagnostic kit.~   "
107350|NCT02162264|"~     To investigate the factors that affect Aricept medication persistence rate and the safety and~     efficacy in patients with Alzheimer's Disease in clinical practice~   "
107351|NCT02162251|"~     To investigate the safety and effectiveness about administration of both donepezil~     hydrochloride and menatine hydrochloride in patients with Alzheimer's Disease in clinical~     practice.~   "
107352|NCT02162238|"~     Introduction: The prevalence of low serum zinc in children under 5 in East Seme, Kisumu is~     73.5% and this is likely due at least in part to low bioavailable zinc from the local~     cereal-based diet. Interventions that will increase zinc intake could prove useful in the~     effort to control zinc deficiency. A potential strategy is to increase zinc intake through~     enriched or fortified water. The Life Straw Family filter (LSF, Verstergaard Frandsen S.A,~     Switzerland) is capable of purifying water and at the same time enriching it with zinc at a~     variable concentration with mean delivery of approximately 1-4mg/L.~      Aims of the study: The primary aim of this study will be to quantify in under 5 year old~     children the contribution of the household LSF device to zinc intake and dietary zinc~     bioavailability in participating households. Secondary objectives are; 1) to assess change in~     serum zinc levels, growth, morbidity in the intervention group compared to control; 2) to~     characterize composition of the intestinal flora of children in the intervention group~     compared to control.~      Study Design and Methods:~      Consenting households from East Seme, Kisumu, Kenya will be randomly allocated to 2 treatment~     arms in an effectiveness study (90 under-five's per treatment arm). Group one will receive~     the LSF device with the zinc delivery system; group 2 will receive a LSF without the zinc~     delivery system.~      Zinc intake will be assessed in a subsample of the under 5 year old children enrolled in the~     effectiveness trial (n=100). This will be estimated by 24 hr recalls administered on 2~     non-consecutive days in the dry and wet season. Selected food samples will be collected for~     direct analysis of zinc and phytic acid content, to supplement data from food composition~     tables (FCT's). The dietary assessment data will be used to estimate the distribution of zinc~     intakes in this age group and the EAR cut-off method will be used to estimate the proportion~     at risk of inadequate intakes.~      Data on water intake from the LSF device will be obtained by personal diaries and tally~     counters. The Zn concentration of the filtered water will be measured weekly. Using these~     data and the data from the dietary assessment, the contribution of the LSF zinc delivery to~     the overall dietary zinc intake will be estimated.~      The effectiveness study will be conducted as a 6-month double blind randomised trial with 3~     assessment time points (baseline, midpoint and endpoint). Three ml (3ml) whole blood will be~     collected from under 5 year old children enrolled in the households for determination of~     serum zinc (SZn), C-reactive protein (CRP), Alpha-1- acid glycoprotein (AGP) and hemoglobin~     (Hb). Stool samples will be collected from a subsample at baseline, midpoint and endpoint in~     the intervention and control group to assess the composition of the gut microflora and gut~     inflammation. Anthropometrics (weight and height) will be measured at baseline, midpoint and~     endpoint of the study. Weekly active surveillance for incidence and severity of malaria,~     diarrhea and other infectious diseases will be done by questionnaire.~   "
107458|NCT02160847|"~     The purpose of this study is to help overweight or obese children to maintain or reduce their~     body mass index (BMI) through the home-based parent training program the investigators~     developed called DRIVE. The investigators hypothesize that children from families that~     receive the DRIVE program will show greater maintenance or improvement in their BMIs than~     families who do not receive DRIVE.~   "
107353|NCT02162225|"~     The investigators hypothesize that increasing plasma nitrite using dietary nitrate will~     improve platelet function and red cell deformability and decrease MCHC in patients with~     sickle cell disease. The investigators will test this hypothesis through administration of~     daily intake of beetroot juice (Unbeetable - Performance Drink) to patients with sickle cell~     disease for 28 days. The investigators will evaluate the safety of daily beet root juice~     intake in patients with sickle cell disease. In addition, the investigators will measure~     MCHC, red cell deformability, and platelet function (activation and aggregation) in response~     to daily intake of beet root juice in this patient population.~   "
107354|NCT02162212|"~     The primary goal of this project is to determine how advanced glycation end-product (AGEs)~     accumulation and shoulder movement (humeral thoracic range of motion and activity count)~     interact to contribute to shoulder limited joint mobility (LJM), pain and disability, and if~     an intervention consisting of a tailored dose of stretching and active shoulder movement can~     reduce these problems in people with diabetes mellitus (DM). The investigators will focus on~     the following measures that span health domains; Skin intrinsic fluorescence to measure AGEs;~     Ultrasound to measure supraspinatus tendon thickness; 3 dimensional joint range of motion and~     activity counts to measure shoulder movements; and the Disability of the Arm, Shoulder and~     Hand (DASH) questionnaire to measure patient reported pain and disability. The investigators~     will test the innovative hypothesis that metabolic and movement factors interact to cause~     severe shoulder problems in people with DM and that an optimized shoulder movement~     intervention can have an important impact on reducing the development of limited joint~     mobility, pain and disability in this population.~   "
107355|NCT02162199|"~     The sponsor is trying to develop a medicine for infections that are not cured by regular~     antibiotics. They have an experimental drug called Debio 1450 that may work. They need about~     48 healthy adults to volunteer for this study.~      This study looks at what the body does to the drug. It measures how the amount of drug in~     blood and urine changes over time.~      From the screening visit through the follow-up visit may be up to 40 days. Volunteers go to~     the clinic in Baltimore for a screening visit. The study doctor chooses qualified volunteers~     to participate or serve as alternates. Alternates might not actually complete the study~     procedures.~      The study doctor divides participants into groups of eight. Six receive Debio 1450 and 2~     receive Placebo. The drug each participant receives is decided by chance - like flipping a~     coin.~      Eligible volunteers check into the clinic for testing and those chosen to participate remain~     for a 5-day/ 4-night stay. The clinic serves standard meals, except when fasting is required.~     Participants must stay at the clinic for the length of the study.~      This study is a dose escalation study. That means that if no safety concerns come up a new~     group starts. Each new group of eight participants receives more capsules.~      The study product is contained in capsules. Each capsule contains either placebo or 40 mg~     Debio 1450. After fasting overnight, the first two participants in the group receive their~     capsules. One gets Debio 1450 and one gets Placebo. If these participants tolerate side~     effects for 24 hours, the remaining six participants receive their assigned capsules.~      The plan is to increase the dose for the next group. The study doctor reviews the~     measurements collected from each group after three days. He may decide to repeat, increase,~     or lower the dose or even stop the study. The most any participant receives is 800 mg in 20~     capsules.~   "
107356|NCT02162186|"~     The study will evaluate the radiographs (x-rays) of 100 patients with a TriFIT total hip at 2~     weeks, 3 months, 6 months, 12 months, and yearly following surgery to see if there has been~     any movement or wear in the hip stem over the course of the study. The study will also record~     clinical data on each patient using various functional tests and questionnaires at the same~     intervals.~   "
107357|NCT02162173|"~     Background: Familial adenomatous polyposis (FAP) patients are at risk to develop~     periampullary and non-ampullary adenoma. Either a routine biopsy or an endoscopic removal of~     the lesion is generally required to identify the presence of adenoma. However, the risk of~     tissue sampling from the ampulla is high and non-ampullary polyps are sometimes numerous,~     therefore resecting all the lesions is time consuming. To support the PIVI (Preservation and~     Incorporation of Valuable endoscopic Innovations) initiative, a real-time diagnosis with NPV≥~     90% is required.~      Objective: To evaluate the diagnostic values of duodenal adenoma by dual focus NBI (dNBI) and~     probe-based confocal endomicroscopy (pCLE) in FAP patients.~      Design: Diagnostic study.~      Setting: Single tertiary-care referral center.~      Patients: Twenty-six patients with previously diagnosed with FAP.~      Intervention: Surveillance EGD with dNBI and pCLE. A real time adenoma reading was done by~     two different endoscopists for each of the technique. Histology from the matched lesion was~     used as the gold standard.~      Main outcome measurements: Sensitivity, specificity, positive predictive value (PPV), and~     accuracy. With the threshold for negative predictive value (NPV) ≥ 90%~   "
107358|NCT02162160|"~     Generate more information on the use of the Probiotic Intimate Crème regarding feeling of~     dryness and freshness in the intimate area, as well as to evaluate the Lactobacillus flora~     and presence of coliform bacteria in respect to E. coli in the intimate area of women before~     use of the crème and at the end of a 10 days crème-usage (day 8-10), as well as 10 days after~     (9-11 days) finished crème-usage.~      The hypothesis is that lactobacilli can survive in the intimate area of postmenopausal women~     with use of a probiotic creme.~   "
107359|NCT02162147|"~     Patient safety is an internationally recognized health care priority. Canadian data suggests~     that about 8% of adults admitted to hospital experience unintended harm (or 'adverse events')~     from the health care provided during their hospital stay. On a national level, this~     represents almost 25,000 preventable deaths among hospitalized adults each year. The~     emergency department is recognized as a high-risk environment for adverse events but most~     patient safety research is not specific to the emergency department. As well, the vast~     majority of people treated in the emergency department are sent home after their visit; yet~     safety research focuses primarily on people who are admitted to hospital. Finally, although~     children have also been identified as particularly high risk for suffering adverse events,~     very little research has been done on how often these events occur among children who visit~     the emergency department. Our study will address this gap in our knowledge about patient~     safety and provide important information on the frequency, severity and preventability of~     adverse events occurring among children in the emergency department. This information will~     help us to improve the safety of emergency department care for all Canadian children.~   "
107360|NCT02162134|"~     Laparoscopic cholecystectomy is now very common procedure to remove the gall bladder from~     abdomen. After this procedure many patients suffer from the non functioning of intestine and~     stomach which is very common after any abdominal surgery. Many efforts tried to reduce this~     non functioning period or postoperative ileus but non of them was superior later on. The~     investigators want to evaluate the role of chewing gum for reducing postoperative ileus. The~     investigators hypothesis is that Chewing gum after laparoscopic cholecystectomy reduces~     postoperative ileus and sugared preparations are more effective to reduce it.~   "
107362|NCT02162095|"~     Patients with chronic obstructive pulmonary disease suffer from significant cardiovascular~     morbidity and mortality. This study wants to determine whether chronic obstructive pulmonary~     disease might be a risk factor for coronary atherosclerosis and other cardiac markers~     independent of conventional cardiovascular risk factors. The study is designed as a~     retrospective matched case-control study with follow-up via telephone interview.~   "
107363|NCT02162082|"~     To evaluate the long-term results after recanalization of coronary chronic total occlusions.~   "
107364|NCT02162069|"~     To evaluate the long-term results after transcatheter aortic valve replacement~   "
107365|NCT02162056|"~     To evaluate the safety, performance and efficacy of the bioresorbable vascular scaffold (BVS)~     system in patients with coronary artery disease~   "
107366|NCT02162043|"~     This project aims to evaluate a self-administered screening test for glaucoma, the second~     largest cause of blindness in the western world. New approaches to glaucoma screening are~     needed because a significant number of patients first present to hospitals with~     advanced-stage glaucoma and late presentation is associated with a much higher risk for~     future blindness. This project will develop a new user-friendly visual field test that will~     be made available through the internet for self-testing. It will conduct both hospital-based~     and community-based clinical trials to establish benefits and costs of this new test.~   "
107367|NCT02162030|"~     The purpose of this study is to determine whether a specific component of Acceptance and~     Commitment Therapy (ACT) called 'Self as Context' is an important and necessary part of this~     therapeutic approach.~   "
107368|NCT02162017|"~     This study is an investigator-initiated and conducted, international collaborative,~     regionally organised, multicentre, prospective, cluster randomised, crossover, blinded~     outcome assessment study to compare the effectiveness of the lying flat (0°) head position~     with the sitting up (=30°) head position, in the first 24 hours of admission to hospital for~     patients with acute stroke, on the poor outcome of death or disability over the subsequent 90~     days.~   "
107369|NCT02162004|"~     The potential of currently available diabetes technologies could be further exploited. The~     investigators propose that sensor-augmented insulin pump therapy may be improved by~     continuous correction, i.e. continuous evaluation of the need for correction boluses. In~     practice, this is carried out by running the bolus calculator every 10 minutes. The glucose~     sensor will provide the bolus calculator with glucose input. Many times, the bolus calculator~     will come to the result that no insulin is needed. However, when the blood glucose is above~     the pre-set target value and a correction bolus is needed, an appropriate bolus is~     automatically delivered by the insulin pump.~      The investigators hypothesize that sensor-augmented continuous correction insulin pump~     therapy can reduce hyperglycemia without increasing the risk of hypoglycemia in patients with~     type 1 diabetes.~   "
107370|NCT02161991|"~     Aprepitant is an oral neurokinin-1(NK-1) antagonist which is widely used for the prevention~     of chemotherapy-induced nausea and vomiting(CINV), it is metabolized by CYP34A, however, up~     to now it was still unknown the CINV control rate of aprepitant in Chinese non-small cell~     lung cancer(NSCLC) patients, we hypothesis that CYP3A4 and NK-1 polymorphism would influence~     aprepitant plasma concentration, which may lead to the individual difference of CINV control~     rate.~   "
107371|NCT02161978|"~     project is a pilot prospective, longitudinal, before-after, open label multicentric study.~   "
107372|NCT02161965|"~     The VICTORIA Study (Vascular CalcIfiCation and sTiffness induced by ORal antIcoAgulation) is~     a comparative, parallel, prospective, controlled and randomized study of the structural and~     functional impact of rivaroxaban versus anti-vitamin K drugs on the arterial vasculature.~   "
107373|NCT02161952|"~     The aim of this study was to assess whether two-year treatment with Pirfenidone influence~     necro-inflammation, fibrosis and steatosis in patients with chronic hepatitis C.~   "
107374|NCT02161939|"~     The primary objective of this program is to provide DCV for 24 weeks to be given in~     combination with SOF to subjects with chronic hepatitis C with decompensated cirrhosis or~     post-liver transplant subjects with chronic hepatitis C recurrence with either advanced~     fibrosis or fibrosing cholestatic hepatitis and who have a serious or immediately~     life-threatening condition or experienced an event that has decreased their life expectancy~     to <12 months, therefore, no research hypothesis will be tested and no specific endpoints are~     defined. However, safety data will be collected throughout the study as well as efficacy data~   "
107375|NCT02161926|"~     The prevalence of obesity is growing in elderly with heavy consequences in term of medical~     complications and mortality, so that this is nowadays an important public health issue.~      The major therapeutic solution is dietary restrictions, but and the advantages and the~     metabolic consequences are not well known in elderly. The MONA study main aim is to assess~     the metabolic changes in this population, after dietary restrictions, compared to young~     people.~   "
107376|NCT02161913|"~     Each year over 12,000 spinal cord injuries (SCI) occur in the United States. These injuries~     result in incredibly difficult, long-term, life adjustments both for patients and their~     caregivers. Many families continue to struggle with the physical, emotional and social~     impacts of SCI for months and years after the injury. Family education and support improves~     the outcomes of other challenging long-term conditions such as Traumatic Brain Injury, but~     little effort has been made to provide such interventions for persons with SCI and their~     caregivers. The proposed study will address this problem by refining and testing a group~     treatment for SCI called Multi-family Group (MFG) intervention. The groups will include~     people with SCI and their primary caregivers, and will be facilitated by an educator who is~     a health care provider who works with people with SCI. By providing education about the~     management of SCI and support in an MFG format, quality of life for persons with SCI is~     predicted to be improved. In turn, it is expected that caregivers will also benefit from the~     information, problem-solving activities, and social support that they receive from the~     educators and other group members. The investigators will recruit 32 individuals with SCI who~     have been discharged from inpatient rehabilitation within the previous three years and their~     primary caregivers. Participants will be randomized to the MFG intervention or to an~     education control condition and tested before and after treatment and 6 months following~     treatment. It is hypothesized that participants receiving MFG-SCI will have better outcomes~     than controls on measures of quality of life, health, and adjustment. The study will also~     test whether participants who are more recently discharged from inpatient rehabilitation will~     experience greater benefit from the MFG intervention or the education control intervention.~     If the outcomes support the hypotheses, the MFG intervention should be made available to~     those with SCI and their caregivers.~   "
107377|NCT02161900|"~     TITLE: Randomized Controlled Evaluating the Role of Exercise in Women Undergoing Treatment~     for Breast Cancer~      Yoga and Quality of life:~      Yoga is based on the practice of physical postures, breathing techniques and meditation.~     Philosophically, it aims at increasing the body's ability to master the mind with the goal of~     spiritual awareness and connection. A randomized trial of yoga in women with breast cancer~     undergoing radiation therapy demonstrated an improvement in impact of events scale at 3~     months suggesting that the more intrusive thoughts at 1 month the greater the finding of~     meaning in cancer by 3 months. Randomized studies have demonstrated evidence of yoga~     improving the emotional well being of women with breast cancer and improving their distressed~     mood, thus providing a buffering effect on QOL. The main beneficial effects demonstrated are~     on social functioning. Among patients not receiving chemotherapy, yoga appears to enhance~     emotional well-being and mood and may serve to buffer deterioration in both overall and~     specific domains of QOL.~      EVALUATION TOOLS- European Organisation for Research and Treatment of Cancer-Quality of Life~     Questionnaire (EORTC QLQ-C30 & BR-23) Brief Fatigue Inventory VAS (Pain score) Spirituality~     Questionnaire Pulmonary function test Objective assessment~      STUDY ENDPOINTS- Primary end points- Disease free survival Secondary end points- Quality of~     life & Improvements in overall survival~      STUDY DESIGN TREATMENT PLAN - All newly diagnosed cases with stage I-III of breast cancer who~     present to Tata Memorial Hospital will be randomly assigned to perform either a set of 'Yogic~     and Routine Exercises (referred to as exercise I) or Routine Exercises'(referred to as~     exercise II)./ Patients will begin the exercises within a week of starting treatment.~      Both arms of the study will receive a training session one hour per day for the first week,~     during which they will be instructed to practice daily and maintain a daily log. The other~     evaluation tools will be used as per the assessment time line (enclosed).The exercises in the~     Exercise I arm (Yoga and conventional exercises) will be upgraded within the next 2 days to~     Phase II. Patients will be allowed to attend a minimum of four out of seven days in Phase I~     and II. Patients will be assessed at 6 months for compliance to phase II exercises. Only if~     patients are fulfilling the criteria for accuracy, sequence and duration of phase II~     exercises, will they be taught phase III exercises. Patients who are unable to do phase II~     exercises at 6 months will be re taught phase II exercises. These patients will then be re~     assessed at 1 year for up gradation to phase III. Six months after completion of phase III~     exercises, patients will be assessed for compliance to phase III exercises. Patients will~     also undergo an objective assessment at 1 year. An additional up gradation will be after~     completion of adjuvant therapy at 6 months.~      Patients will be followed up for a period of 5 years. DFS will be measured from the time of~     randomization to either progression or death. Quality of life will be measured at baseline~     and every six monthly using the functional assessment cancer therapy- quality of life.~     Quality of Life analysis at 400 patients will be performed with appropriate correction for~     multiple analyses applied.~      STATISTICAL ANALYSIS- For an expected 50% 5 year disease free survival (DFS) for the control~     group, the expected 5 years DFS for the intervention group will be 60%. With a two-sided~     analysis, and at 80% power and 95% confidence to detect a 10% difference between the arms,~     the sample size would be 761 patients. Assuming a 10% loss to follow up, a total of 850~     patients would be accrued. We expect to complete accrual in 3 year.~      RANDOMIZATION AND STRATIFICATION- Randomization for intervention will be done centrally from~     Clinical Research Secretariat and patient will be stratified by~      Menopausal status: Pre + Peri or Post Neoadjuvant or adjuvant treatment Stage of disease:~     I/II/III ANALYSIS- Disease Free Survival (DFS) will be calculated from the date of~     randomization to the date of local, regional or distant relapse or death from any cause and~     will be censored at the last date of follow up for the patients that are alive and disease~     free or have been lost to follow up.~      Overall Survival (OS) will be calculated from the date of randomization to the date of death~     or censored at the date of last follow up for the patients who are alive or lost to follow~     up. DFS and OS will be evaluated using Kaplan Meier and compared by Log-rank test. The Cox~     proportional hazard model will be used to assess the impact of intervention after correction~     for stratification, menopausal status and age.~   "
107389|NCT02161744|"~     The purpose of this study is: 1.- to assess the safety and tolerability of autologous adipose~     derived stem cells (aADSC) administered intravenously in patients with chronic obstructive~     pulmonary disease, and 2.- to assess if this therapy results in less decrease of lung~     function parameters (FEV1, FEV1/FVC and 6 min walking distance) compared with a control~     baseline of 6 weeks.~      Patients will be followed up for 12 months after the therapy.~   "
107378|NCT02161887|"~     The overall objective of this study is to develop and test an efficient set of self-report~     instruments to measure Complementary and Alternative Medicine(CAM)-relevant contextual~     factors important in healing. The initial phase of the study involves developing and refining~     an item bank. During the initial 'item bank development' phase, the investigators will run~     focus groups and cognitive interviews with individuals who participate in CAM and~     conventional medicine interventions. The next step of instrument development is called~     Calibration, and involves administering the revised item bank to an internet sample and to~     persons who receive services in a CAM clinic and a conventional primary care setting. The~     items will be calibrated using item response theory and classical test theory. This will~     result in a computerized adaptive testing version of the instrument, as well as a static~     short form of the instrument. This current protocol in ClinicalTrials.gov pertains only to~     the final, Validation Phase of the study. The final phase of the project will involve~     conducting initial validation studies of the set of instruments. The set of instruments will~     be called the Healing Encounters and Attitudes Lists (HEAL). The investigators will evaluate~     the convergent, discriminant, and predictive validity of the HEAL instruments in a sample of~     200 persons with chronic low back pain or neck pain who are receiving physical therapy,~     chiropractic care, acupuncture, medical management, or mindfulness-based stress reduction.~     For convergent validity, the HEAL is expected to display moderate to large correlations with~     measures of similar constructs. The HEAL is expected to correlate modestly with self-report~     measures of general psychosocial functioning, in support of discriminant validity. Finally,~     HEAL scores should account for a significant proportion of the variance in treatment outcome,~     supporting predictive validity.~   "
107379|NCT02161874|"~     This study evaluates the T3 implant system for the preservation of alveolar crestal bone and~     the establishment of initial integration. The new surface-treated features of the implant may~     contribute to improved soft and hard tissue healing. The success rate of the T3 implant will~     be no different than that of the control implant, which possess similar geometry but~     different surface treatments.~   "
107380|NCT02161861|"~     cFEE peptide improves the IVF fertilization rate in mouse and fertilization index in human.~     It improves sperm movement's parameters.~      It has been studied over 3 generations of mice and appears without any side effects. The~     Agence de la BioMédecine has given the authorization for testing the peptide in human IVF.~      It is expected to improve the fertilization rate, and thus provide more embryos per IVF~     attempt.~      160 couples will be included over 15 months. Patient sperm parameters should be suitable for~     IVF. Female should be between 18 and 43 year old. Each cohort of eggs will be randomly~     distributed to one of the 2 groups The first group will be inseminated with 105/ml motile~     spermatozoa. The second will be similarly inseminated but in a middle which will be~     supplemented with cFEE 100µM.~      Criteria: number of embryos in each group~   "
107381|NCT02161848|"~     The purpose of this study is to investigate the fraction of fat on a MRI scan of lower bag~     muscles, thighs and calves in patients with the mitochondrial disease chronic progressive~     external ophthalmoplegia (CPEO).~      Additionally an investigation of the volume of the eye muscles will be done and compared to~     the patient's clinical presentation of ptosis and ophthalmoplegia.~   "
107382|NCT02161835|"~     Investigators aimed to investigate whether training can increase fitness levels in patients~     with myotonia, and thereby reduce the symptom of myotonia.~   "
107383|NCT02161822|"~     Statins are widely used as lipid-lowering agents to lower cardiovascular risk with a~     favorable safety profile. In our recent in vitro study, the addition of simvastatin to~     chemoradiotherapy with 5-FU showed synergistic anticancer effect in various colon cancer~     cells (unpublished data). So we planned this study to investigate the synergistic effect of~     simvastatin combined with capecitabine and radiotherapy in locally advanced rectal cancer~     patients.~   "
107384|NCT02161809|"~     The investigators long-term goal is to increase the number of Summer Day Camps (SDC) that~     meet the National Afterschool Association Healthy Eating and Physical Activity (HEPA)~     Standards. The objective is to evaluate the effectiveness of a multi-component intervention~     designed to increase children's PA levels and improve the quality of lunches and snacks~     children consume in SDCs. The HEPA intervention is designed to target children, parents,~     staff, program leaders, and the SDC environment and uses a train-the-trainer model with SDC~     leaders to train their staff to deliver and integrate the intervention into routine practice.~     In the proposed study, the investigators will evaluate these HEPA strategies, using a 4-year~     randomized controlled trial with 20 SDCs. An important feature of the study will be the~     evaluation of maintenance of the intervention after the removal of research support (e.g.,~     training, boosters) during the final year, as well as costs associated with implementation.~      The investigators hypothesize that intervention SDCs will achieve significantly greater~     increases in HEPA, compared to control SDCs. The investigators expect the study to support~     the cost-effectiveness and maintenance of our strategies for promoting HEPA that will~     facilitate SDCs meeting newly-established HEPA standards for this setting.~   "
107385|NCT02161796|"~     This study evaluates the concentration of FG-4592 in the blood over a certain period after~     the intake of different doses, and assesses the effects, the safety and the tolerability of~     the study drug in healthy young and elderly male and female subjects.~      On Day 1 of each of 4 periods subjects receive different single doses of FG-4592 or a~     placebo, depending on the treatment sequence to which they are randomized. For each period~     the subjects remain in the clinic for 6 days (Days -2 to 4). They are discharged after all~     assessments are completed on Day 4 of each period, and return for an End of Study visit (ESV)~     between 5 and 9 days after the last assessment of Period 4.~   "
107386|NCT02161783|"~     This is a guideline for the treatment of graft failure after hematopoietic stem cell~     transplant (HSCT). This regimen, consisting of cyclophosphamide and fludarabine with low dose~     total body irradiation (TBI) is designed to promote donor engraftment by day 42 after initial~     graft failure.~      The graft will consist of bone marrow or G-CSF mobilized peripheral blood from a~     haploidentical related donor. The source of stem cells will be determined by the transplant~     team based on factors such as patient's age, medical history, donor availability and will be~     according to the current University of Minnesota Blood and Marrow Transplantation Program~     selection guidelines.~   "
107387|NCT02161770|"~     This is a 2-part study in patients with advanced solid tumours. Part A will investigate the~     pharmacokinetics (PK) of AZD9291 in patients with mild or moderate hepatic impairment~     compared to patients with normal hepatic function; Part B will allow any patient with mild or~     moderate hepatic impairment or normal hepatic function, who completes Part A, continued~     access to AZD9291 after the PK phase and will provide additional safety data.~   "
107388|NCT02161757|"~     A 52-Week, Multicentre, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Phase 3~     Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents with~     Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist~   "
107390|NCT02161731|"~     All study participants will receive both warfarin and a study drug called evacetrapib. The~     main purpose of this study is to look at how much warfarin gets into the blood stream and how~     long it takes the body to get rid of warfarin when given both with and without evacetrapib.~     Another purpose is to evaluate the effectiveness of warfarin therapy to prevent blood clots~     when given with evacetrapib by measuring the time it takes for blood to clot and comparing it~     to an average of the international normalized ratio (INR). INR measures the time it takes for~     blood to clot and compares it to an average.~      The study will last approximately 5 weeks, not including screening.~   "
107391|NCT02161718|"~     This double-blind, randomized study will evaluate the efficacy, safety and tolerability of~     ALKS 3831 in subjects with schizophrenia and alcohol use disorder (AUD).~   "
107392|NCT02161705|"~     Primary Objective To determine if post-operative static pain scores differ between women~     undergoing bilateral mastectomy followed by bilateral immediate tissue expander~     reconstruction randomized either to ropivacaine- (treatment) or saline- (placebo)~     pre-operatively placed paravertebral blocks.~      Post-operative pain scores will be measured by a 0-10 Likert scale 6 hours after the end of~     surgery while the patient is still hospitalized (post-operative day 0). This will be~     patient-provided data. Unblinded data analysis will compare scores between treatment and~     control groups.~      Secondary Objectives To determine if post-operative moving pain scores, opioids use, nausea,~     and sleep interference differ between women undergoing bilateral mastectomy followed by~     bilateral immediate tissue expander reconstruction randomized either to ropivacaine-~     (treatment) or saline- (placebo) pre-operatively placed paravertebral blocks.~      Pain score, opioids use, nausea, and sleep interference data will be collected via patient~     self-report. When possible (i.e., while hospitalized) objective data on opioids and other~     pain medication administered to the patient will be used.~      Tertiary Objectives To determine if long-term changes in Quality of Life scores [the RAND-36~     Health Survey, Disability of the Arm, Shoulder, and Hand (Quick DASH) questionnaire, and~     Breast-Q scores] differ between women undergoing bilateral mastectomy followed by bilateral~     immediate tissue expander reconstruction randomized either to ropivacaine- (treatment) or~     saline- (placebo) pre-operatively placed paravertebral blocks.~      This data will be collected via validated questionnaires through patient interviews at~     3-months, 2-years, and 4-years (±14 days) after surgery.~      Once enrolled in the study, participants will be encouraged to remain in the study for the 4~     years following surgery in order to get final pain scores and quality-of-life/health outcome~     survey information. Participants who cannot be contacted after several phone attempts and the~     sending of 2 certified letters via US Postal Service for 3-month, 2-year, and/or 4-year~     outcome assessments will be considered lost to follow-up.~   "
107393|NCT02161692|"~     The purpose of this study is to determine whether the use of a sequential high dose~     chemotherapy is more effective than conventional dose (i.e. 4 cycles of cisplatin, etoposide,~     and bleomycin [PEB]) in patients with metastatic poor prognosis germ cell tumors.~   "
107394|NCT02161679|"~     This is a Phase II, open-label study that evaluates the safety and efficacy of IMMU-132 alone~     and in combination with carboplatin in patients with triple-negative breast cancer. IMMU132~     will be administered once-weekly for the first 2 weeks of 3-week treatment cycles. For those~     patients assigned to also receive carboplatin, will receive it on the same schedules starting~     30 minutes after the completion of IMMU-132 administration. Patients may receive up to a~     maximum total of 8 cycles.~   "
107395|NCT02161666|"~     To examine pancreatic islet function and incretin function during intravenous and oral~     stimulation >2 years after gastric bypass surgery in patients with normal glucose tolerance.~     We hypothesize that islet cell and incretin function is enhanced in response to oral, but not~     intravenous, stimulation - i.e. incretin released from the gut in response to oral~     stimulation play a key role for the enhanced islet function after gastric bypass surgery.~   "
107396|NCT02161653|"~     The purpose of this study is to determine whether metadoxine is effective for improve~     survival and reduced oxidative stress in patients with severe alcoholic hepatitis.~   "
107397|NCT02161640|"~     Inflammatory Bowel Diseases (IBD) is a group of relapsing and remitting gut inflammatory~     conditions acquired due to genetic susceptibility and/or environmental triggers. The disease~     manifestations are being increasingly seen in young children and the life-long debilitation~     has a severe effect on quality of life. Limited evidence suggests, although rare, in some~     young IBD individuals vascular complications may ensue. This leads to increased risk of~     vascular problems such as thrombosis, arterial disease and stroke.~      In the present project we aim to study and highlight potential vascular changes in young~     Inflammatory Bowel Disease (IBD) patients and compare these changes with age and gender~     matched controls. Vasculature will be measured in multiple ways including blood analysis in~     the laboratory and non-invasive, physiological measures of arterial health (e.g. ultrasound~     arterial scan). Our overall goal is to identify biomarkers indicative of increased risk of~     vascular dysfunction as this will open new avenues for early therapeutic intervention.~   "
107398|NCT02161627|"~     The aims of the study are to compare automatic control of spinal cord stimulation with manual~     control in patients with chronic pain of the trunk and limbs~   "
107399|NCT02161614|"~     The aim of this study is to evaluate the vascular effects of estradiol valerate on~     climacteric women measured by flow-mediated evaluation of the brachial artery using high~     resolution ultrasound and compare to placebo.~   "
107400|NCT02161601|"~     During emergency anesthesia (rapid sequence induction) , a firm pressure is applied to the~     cricoid cartilage of the patient in order to prevent passive regurgitation of gastric content~     into the pharynx. This maneuver is called cricoid pressure.~      Cricoid pressure is often performed incorrectly, due to difficulties to locate the cricoid~     cartilage in many patients. Despite this, the effectiveness of an incorrectly applied cricoid~     pressure has not been investigated. In this study we have used high-resolution manometry~     (HRM) to evaluate pressures in the upper esophagus during correctly applied cricoid pressure~     (against the cricoid cartilage) compared to incorrectly applied cricoid pressure (against the~     thyroid cartilage and against the trachea) during a rapid sequence induction.~   "
107401|NCT02161588|"~     This trial is conducted in Asia. The aim of the trial is to investigate the pharmacokinetics~     (the exposure of the trial drug in the body), pharmacodynamics (the effect of the~     investigated drug on the body), safety and tolerability of oral semaglutide in healthy male~     Japanese and Caucasian subjects.~   "
107425|NCT02161276|"~     Treatment of diabetes mellitus with Traditional Chinese Medicine has a long history.~      aim： --establish the optimal dosage of traditional Chinese medicine Tang Ning Tongluo Capsule~     to treat type II diabetes mellitus.~      ---Preliminary evaluate the clinical efficacy and safety of Tangning Tongluo Capsule in the~     treatment of type II diabetes~   "
107426|NCT02161263|"~     The investigators are administering a validated questionnaire looking at patient reported~     quality of life and quality of vision after LASIK surgery~   "
107427|NCT02161250|"~     Hypothesis: A beverage with a resistant starch will blunt and sustain the post-prandial rise~     in blood glucose and insulin concentrations compared to beverage with maltodextrin (an easily~     digested carbohydrate).~   "
142072|NCT01707667|"~     To evaluate the different effects of prucalopride and PEG 3350 + electrolytes on colon motor~     activity in subjects that are chronically constipated.~   "
107402|NCT02161575|"~     AMD (Age Related Macular Degeneration) is the leading cause of severe visual loss and~     blindness registration in the UK . It is a disease which affects the retina (the nerve and~     blood vessel network at the back of the eye responsible for vision). Patients can suffer with~     severe visual loss and have difficulties with every day tasks such as recognising faces,~     reading & driving.~      There are two variations of the disease, a 'dry' type & a 'wet' type also known as~     neovascular AMD (nAMD). In wet/nAMD new vessels grow from the blood supply underneath the~     retina, in part due to higher than normal levels of a protein called Vascular Endothelial~     Growth Factor (VEGF). Since the introduction of drugs which block VEGF, visual outcomes for~     patients with wAMD have dramatically improved.~      There are 2 widely used treatments; ranibizumab and aflibercept. Whilst the majority of~     patients have a successful outcome with treatment, many patients experience suboptimal~     response. This study will evaluate if these patients experience a benefit from a switch to a~     different antiVEGF drug treatment. In this study nAMD patients who are showing no or poor to~     response to treatment with aflibercept will be switched to ranibizumab to assess if there is~     any benefit in terms of treatment outcomes.~      Patients will visit the hospital clinic 8 times over the 7 - 8 month study period. Monthly~     ranibizumab injections will be given for the first 3 months, then monthly as required for the~     next 3 months. 162 patients will be treated in around 33 centres in Europe, of which~     approximately 127 patients will be included in the UK~   "
107403|NCT02161562|"~     This trial will assess the efficacy of optimized re-treatment therapy with omalizumab (150mg~     or 300mg) after relapse, in patients with Chronic Spontaneous Urticaria who were clinically~     well-controlled following their first course of treatment with omalizumab (150mg or 300mg).~      Will also assess the benefit of uptitrating to 300mg dose those patients who are not~     well-controlled following their first course of treatment with omalizumab 150mg.~   "
107404|NCT02161549|"~     Motus Gl is developing a single-use device that attaches to a standard colonoscope, thereby~     integrating colon cleansing, screening and treatment into one procedure.~      The device creates turbulence within the colon using water jets. The colon's fecal fluids are~     evacuated by the system.~   "
107405|NCT02161536|"~     The purpose of this study is evaluate the Motus GI Colon Cleansing system performance.~   "
107406|NCT02161523|"~     In addition to their role in allergic inflammation, mast cells are often found at the site of~     tumors. They have been attributed both to pro- and anti-tumorigenic roles depending on the~     tumor type. Secretion of mast cell mediators such as histamine, tryptase, fibroblast growth~     factor (b-FGF), vascular endothelial growth factor (VEGF) and interleukin-8 (IL-8) can~     enhance tumor growth and angiogenesis while TNF-a and heparin act as tumor suppressors.~      The non-small cell lung cancer constitutes the majority of cases of lung cancer. In lung~     cancer, mast cell numbers correlate with tumor angiogenesis and poor prognosis.~      In this work, we are interested to determine the factors in lung cancer microenvironment that~     attribute to mast cell activation. Beside the tumor cells themselves, the cancer~     microenvironment includes other cells such as fibroblasts. The fibroblasts arising from tumor~     stroma, called cancer-associated fibroblasts (CAFs), undergo activation, and have different~     feature compared to normal fibroblasts (NFs). In this work we are interested to determine~     whether CAF cells derived from lung tumors, together with the lung cancer cells, or~     microvesicles-derived from these cells, are able to stimulate mast cells to degranulate and/~     or to release various cytokines and chemokines.~      For this propose, during surgery of patients with lung cancer, we will take unnecessary~     sample from the cancer and from normal area for purification of CAF or normal fibroblast~     cells. Those cells will be co-cultured with both lung cancer cell line (A-549) or~     microvesicles-derived from these cells, and human mast cell line (LAD2). Supernatants will be~     collected for determine degranulation and cytokine release from these mast cells.~   "
107407|NCT02161510|"~     The objective of this study is to identify a safe dose of MK-2248 in participants with~     Hepatitis C Virus (HCV) that mediates at least a 3 log10 reduction in viral load (VL) from~     baseline. It is anticipated that once-daily administration of a safe and well tolerated dose~     of MK-2248 will reduce VL by at least 3 log10 IU/mL.~   "
107408|NCT02161497|"~     The investigators are studying the difference between the history taken from parents prior to~     their child's anesthesia to information gleaned routinely from a patient information system~     called Ofek.~   "
107409|NCT02161484|"~     The purpose of this research study is to evaluate the analgesic efficacy of adding a single~     shot parasacral (sciatic) nerve block to a continuous lumbar plexus block in patients~     undergoing total hip replacement.~   "
107410|NCT02161471|"~     The purpose of this study is to determine whether patients with repaired congenital heart~     disease show differences in size or function of their heart atria compared to normal controls~     and depending on the nature of their heart disease.~   "
107411|NCT02161458|"~     Alzheimers disease (AD) is a devastating illness, estimated to affect 5 million patients in~     the United States alone and projected to increase dramatically over the next decades as the~     population ages unless preventive measures can be developed. The investigators have~     preliminary evidence that selective serotonin reuptake inhibitor (SSRI) antidepressants lower~     the amount of amyloid plaques in the human brain. The interventions now propose to study the~     effects of an SSRI (escitalopram) on levels of amyloid beta peptide (the major constituent of~     the plaques) in the cerebrospinal fluid (CSF) of cognitively normal older adults.~   "
107412|NCT02161445|"~     the gold standard for the diagnostic of acute heart failure is based on clinical, biological~     (BNP levels) and echocardiographic findings, but still in some cases, the diagnosis is~     difficult and requires further investigations.~      BNP dosages and echocardiography are not always available in many medical centers, especially~     in emergency departements, and are expensive.~      we investigated the use of alternative methods, such as the systolic time intervals (STI), in~     the diagnosis of acute heart failure (AHF) in emergency departement patients consulting for~     dyspnea.~   "
107413|NCT02161432|"~     To determine the relative bioavailability of an BI 187004 tablet formulation compared to an~     oral solution of BI 187004 and to assess the influence of food on the bioavailability of the~     tablet formulation.~   "
107428|NCT02161237|"~     Primary purpose of this study is to compare renal function between subjects receiving~     optimized dose Advagraf® over 52 weeks after kidney transplantation and subjects receiving~     standard dose Advagraf®. Pilot results of safety and efficacy in optimized dose Advagraf®~     over 52 weeks after kidney transplantation will also be obtained.~   "
107414|NCT02161419|"~     This is a study to investigate the potential clinical benefit of roniciclib when given in~     combination with chemotherapy Carboplatin / Etoposide or Cisplatin / Etoposide as first line~     treatment in patients with extensive disease small cell lung cancer. Approximately 140~     patients will be randomized (1:1) to receive treatment with either roniciclib or placebo in~     combination with chemotherapy.~      Roniciclib is an oral (i.e. taken by mouth) protein kinase inhibitor. A kinase inhibitor~     targets certain key proteins that are essential for the survival of the cancer cell. The~     growth of the tumor may be decreased by preventing these specific proteins from functioning.~     By specifically targeting these proteins, roniciclib in combination with chemotherapy may~     stop cancer growth.~      The primary endpoint (the most meaningful result to be tracked) of this study is based on the~     progression free survival, i.e. the time the disease is not worsening. The aim is to show~     that the therapy with roniciclib in combination with chemotherapy prolongs the time the~     disease is not worsening in this patient population compared to patients receiving placebo in~     combination with chemotherapy.~   "
107415|NCT02161406|"~     The study hypothesis is that SC abatacept is safe and shows evidence of efficacy (improvement~     in modified Rodnan score [mRSS]) in patients with diffuse cutaneous systemic sclerosis~     (dcScc) compared to matching placebo.~   "
107416|NCT02161393|"~     The primary aim of this study is to assess the feasibility of conducting a trial to~     investigate the effectiveness of a physical activity intervention (physical activity~     consultation and a pedometer-based walking programme) versus pulmonary rehabilitation in~     improving physical activity in COPD.~      Objectives are:~      (i) to assess the feasibility (patient recruitment, adherence, drop-outs and adverse events)~     of delivering a physical activity intervention in the COPD patient population versus~     pulmonary rehabilitation; (ii) to explore users perceptions relating to satisfaction and~     benefits of a physical activity intervention versus pulmonary rehabilitation; (iii) to~     investigate between and within group change in physical activity, exercise capacity, quality~     of life, self-efficacy and changes in the transtheoretical model with the physical activity~     intervention versus pulmonary rehabilitation; and (iv) to examine the cost of delivering a~     physical activity intervention versus pulmonary rehabilitation for patients with COPD.~      The hypothesis for this study is that it will be feasible to conduct a trial that will~     investigate the effectiveness of a physical activity intervention (physical activity~     consultation and a pedometer-based walking programme) compared to pulmonary rehabilitation~     for improving physical activity in COPD. The study will provide important information about~     interventions designed to promote and maintain physical activity, improve patient outcomes~     and increase patients' choice relating to exercise and physical activity interventions. It~     will provide a rationale and data for an adequately powered clinical trial evaluating the~     effects of a physical activity intervention.~   "
107417|NCT02161380|"~     Hypotheses:~      The primary hypothesis being tested is that there will be no toxicity resulting in loss of~     vision to no light perception in injected eyes.~   "
107418|NCT02161367|"~     Post-operative ileus is a common complication following abdominal surgery. It results in~     abdominal distension, nausea and vomiting as well as abdominal pain. Furthermore, this~     results in prolonged hospital stay and occasionally readmission following abdominal~     surgery.The etiology of post-operative ileus is multifactorial and studies evaluating~     potential treatment options are abundant, though few reliable interventions exist. This study~     proposal describes a double-blinded randomized controlled trial investigating the effect of~     simethicone on post-operative ileus in patients undergoing colorectal surgery.~   "
107419|NCT02161354|"~     To evaluate the efficacy of a single dose NTC-510 or NTC-510A for dental pain following third~     molar extraction.~   "
107420|NCT02161341|"~     The ocular surface is the first line of defence of the eye, it is therefore where external~     threats are sensed, and potential insults neutralised. Over the course of evolution, various~     microbes, especially bacteriae, have come to colonise the ocular surface as commensals. The~     commensals have a role to maintain the homeostasis of the ocular surface. 1 The innate~     immunity of the ocular surface is very active, and consists of active mechanisms to suppress~     inflammation 2. For example, there exist macrophages, dendritic cells, suppressor cells,~     regulatory cells, B cells, IgA, lysozyme, anti-microbial peptides and barriers against~     external agents. The normal commensals of the ocular surface maintain a basal level of~     activation of innate defence by stimulating the pattern recognition receptors on ocular~     surface epithelial cells. This normal composition of microbes is important since inflammation~     and infection will result if there is introduction of a pathogenic strain that overcomes the~     flora, or if a dominant strain secretes excessively immunogenic products, such as the~     exotoxin A of Staphylococcus which triggers marginal keratitis, a form of type IV~     hypersensitivity. The flora load of microbiome could also influence tear function as a higher~     flora load was found to be associated with increased mucin degradation 3 and reduced globet~     cell densitiy 4. Previous studies [I'm not sure which studies these are] at SERI/SNEC also~     point to the importance of microbes. For example, in dry eye patients, there is increased~     lysophospholipids in the tear, and this may contribute to inflammatory mediators such as~     arachidonic acid and other metabolites. The lysophospholipids are formed by phospholipase A2~     reactions, and the latter may be microbial in origin. Since dry eye is a known inflammatory~     disease of the ocular surface, this is one way that microbes can contribute to the pathology.~   "
107421|NCT02161328|"~     The changes of local pulmonary ventilation should be registered with an electric impedance~     tomography (EIT) before and after a dilatative tracheotomy. The hypothesis is that the EIT~     cannot show changes in local ventilation due to the tracheotomy.~   "
107422|NCT02161315|"~     Steroid Aromatase Inhibitors and Non-Steroid Aromatase Inhibitors in Late Stage Breast Cancer~     is the recommended scheme in National Comprehensive Cancer Network (NCCN) guideline. In the~     past controlled clinical trials with small sample.~   "
107423|NCT02161302|"~     The purpose of this study is to determine if transcranial direct current stimulation (tDCS)~     is effective in the treatment of chronic pelvic pain associated with endometriosis~   "
107424|NCT02161289|"~     Objectives~        1. To evaluate the acceptability and feasibility of standard HIV prevention package among~          Thai men who have sex with men (MSM)~        2. To conduct a pilot study to demonstrate the acceptability and feasibility of~          internet-based social networking, asymptomatic sexually transmitted infection diagnosis~          and treatment and pre-exposure prophylaxis strategies as potential HIV prevention~          methods among Thai MSM~        3. To use mathematical modeling to identify the most effective HIV prevention package~          optimized for Thai MSM~      Subject population: HIV-negative MSM clients of the Thai Red Cross Anonymous Clinic (TRC-AC),~     age ≥18 years old,Each participant will have a 12-month follow-up duration in the study.~   "
107429|NCT02161224|"~     The effect of moderately diminished liver function on the exposure, safety and tolerability~     of a single dose of FG-4592 is studied in male and female subjects. The results are compared~     to the data gained from subjects with normal liver function.~   "
107431|NCT02161198|"~     Y-75/ginsan is an acidic polysaccharide with a molecular weight of 150,000 Da, isolated from~     the aqueous Korean Panax ginseng extract. Preclinical laboratory studies have shown its~     function as an immunomodulatory molecule. The present study performed to evaluate the safety~     and beneficial effects of Y-75 on immune function in a group of healthy adults.~      The focus of this trial was modulation of innate immunity, comprising cytotoxic activity of~     natural killer cells, phagocytic activity of polymorphonuclear leukocytes and mononuclear~     phagocytes, and serum levels of monocyte-derived mediators.~   "
107432|NCT02161185|"~     The purpose of this study is to examine the long-term safety and tolerability of USL261 in~     the treatment of seizure clusters.~   "
107433|NCT02161172|"~     Patients with traumatic brain injury are likely to present with cognitive, psychological,~     emotional and behavioral problems during different periods, all of which affect patients'~     life quality seriously. The aim of this study was to assess cognitive and psychosocial~     outcome in patients with mild traumatic brain injury, and to determine the risk factors~     associated with cognitive and psychological outcome. Mini-mental state examination (MMSE),~     activities of daily living scale (ADL), the Hospital Anxiety Depression Scale (HADS) and~     mental health symptom checklist (SCL-90) were used to assess the cognitive performance and~     psychological outcomes in 360 patients with mild traumatic brain injury. Chi-square, Fisher's~     exact tests and Logistic regression analysis were used to analyze the risk factors.~   "
107434|NCT02161159|"~     This study will evaluate real world pattern of use of BOTOX® in actual clinical practice in~     patients with idiopathic overactive bladder (iOAB) with urinary incontinence whose symptoms~     have not been adequately managed by oral anticholinergic therapy.~   "
107435|NCT02161146|"~     This study will evaluate the safety and efficacy of AGN-229666 for the prevention of~     allergen-mediated conjunctivitis.~   "
107436|NCT02161133|"~     There are almost 700,000 Gulf War Veterans (GWV) with 25-30% suffering from a devastating~     multi-symptom illness coined Gulf War Illness (GWI). GWV with GWI report significant activity~     limitations and chronic cognitive problems consistent with problem-solving deficits.~     Problem-solving is considered the most complex of cognitive abilities and is what enables us~     to conduct complicated behaviors such as setting goals, sequencing and multi-tasking. As a~     result studies have found that problem-solving deficits are prospectively related to a~     greater risk of disability. Despite published reports documenting these problems there are no~     treatments that target the problem-solving deficits of GWI. This proposal seeks to determine~     whether Problem-Solving Therapy, a patient centered cognitive rehabilitation therapy, can~     reduce disability by compensating for problem-solving deficits.~   "
107437|NCT02161120|"~     The purpose of this study is to evaluate if low-FODMAP (Fermented Oligo-, Di-,~     Monosaccharides And Polyols) rye bread is better tolerated in irritable bowel syndrome than~     commonly available traditional rye bread higher in FODMAP carbohydrates. The study also aims~     to investigate patients' compliance to rye bread regimen, potential changes is gut microbiota~     and hydrogen production during the test periods (a marker of large bowel fermentation of~     poorly absorbed carbohydrates).~   "
107438|NCT02161107|"~     The purpose of this study is to determine whether it is safe to administer Grass-SPIRE to~     subjects suffering from both grass allergy and asthma~   "
107439|NCT02161094|"~     Objectives:Physicians from the Shanghai Jiading community clinic were invited to attend the~     study seminar. Those physicians who meet the criteria of the study plan were being selected~     to participate voluntarily. From their patient's record, the physicians will recruit a total~     of 1300 patients with type 2 diabetes who meet the criteria of the Jiading Study.~      The study utilizes the social learning theory that motivation and social support are~     important to make behavioral change. The mechanism of providing incentive for patients and~     physicians will be established after the permission from the Internal Review Board of the~     hospital and will be approved by the hospital director. Physicians and their patients were~     randomly divided into 4 groups: Group 1- Physicians only; Group 2 - Patients only; Group 3 -~     Both Physicians and Patients, Group 4 - control. Groups 1-3 will receive incentives if they~     can maintain the ideal level of Hemoglobin A1c (HbA1c) during the 3-years study period. The~     forth group serves as a control and will not receive any incentive but will be provided~     diabetes education booklet and group education courses for DM control as usual. Based on the~     annual evaluation of the level of improvement on HbA1c that is a joint effort of both~     patients and physicians to achieve the targeted goal of adequate HBA1c level, the value of~     incentives will be increased accordingly. Our ultimate goal is to evaluate the effectiveness~     of incentive as an intervention tool to improve the health status of the diabetic patients.~   "
107440|NCT02161081|"~     Among the current myocardial CT perfusion techniques, dynamic CT perfusion technique is most~     advantageous in obtaining information on myocardial blood flow and volume. However, dynamic~     CT perfusion technique involves higher radiation dose than static CT techniques. Patients~     have to take a breath hold during 30 seconds with current dynamic CT perfusion protocol. If~     patients cannot hold their breath, anterior or inferior myocardium might be excluded due to~     limited scan coverage of a 128-slice dual-source CT scanner.~      Reduction of scanning duration of dynamic CT perfusion may not only reduce radiation~     exposure, but also make patients more comfortable. Therefore, the investigators intended to~     propose a modified scan protocol with shorter scan duration and compare diagnostic accuracy~     of a modified scan protocol with the current scan protocol.~   "
107441|NCT02161068|"~     This is a retrospective analysis to include demographic, clinical, biochemical, and genetic~     data that will further explore the natural history of ADPKD and assess the factors that are~     likely to be associated with the progression of disease and the incidence of complications~     including progressive chronic kidney disease, cardiovascular disease, and cerebrovascular~     disease.~   "
107442|NCT02161055|"~     An increase in blood glucose is a common clinical symptom in patients following traumatic~     brain injury. Studies confirm that death after traumatic brain injury was not only associated~     with nerve injury, but also correlated with abnormal physiological and metabolic reactions.~     Hyperglycemia is a manifestation of physiological and metabolic disorders after traumatic~     brain injury. Traumatic brain injury induced hyperglycemia, and then aggravated secondary~     injury to the brain. Therefore, it is of important clinical significance to study the~     treatment of hyperglycemia after traumatic brain injury.~   "
143849|NCT01684462|"~     In this clinical study, the efficacy and safety of ALbumin is to be evaluated for the~     patients occurred within 12 hours of acute ischemic stroke.~   "
107443|NCT02161042|"~     Blood transfusion is often used to treat patients with Anemia. The period of storage of blood~     products prior to use for transfusion may vary. Prolonged storage of blood products may~     result in changing their biochemistry.~      This study aims to look into whether the transfusion of old blood, which is stored for more~     than 7 days, as compared to the transfusion of Fresh blood, which is stored for less than 7~     days, will affect endothelial function.~   "
107444|NCT02161029|"~     The purpose of this study is to determine whether the newly constructed CE (Conformité~     Européenne) marked drill biopsy instrument for flexible endoscopes can make possible~     representative biopsies of the increasing numbers of submucosal tumours in the~     gastrointestinal tract. The amount of submucous tissue ( micrograms and in % of all the~     biopsy) harvested with the new drill biopsy instrument used in flexible endoscopy~     investigations is measured in the study and compared to the amount of submucous tissue~     harvested with the existing biopsy forceps.~   "
107445|NCT02161016|"~     This is a single arm pilot study in patients requiring surgical fusion in the foot or ankle.~     Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem~     cells. This cohort study will enroll 24 patients total at 1 site. After subjects have signed~     an informed consent, the baseline visit and examinations will be completed. Patients will be~     evaluated at 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months after surgery.~   "
107446|NCT02161003|"~     The problem of the incontinence imposes considerable strain on the child and their parents.~     These patients suffer from a long-life handicap and they need support and follow-up. The cost~     associated with these diseases has clearly been illustrated to be a major component in the~     healthcare spending picture, may be adding hundreds of thousands of dollars to healthcare~     cost, as well as loss of productivity in the work force. Fecal incontinence treatment has~     been a difficult challenge for surgeons for several generations until now the current~     traditional surgical result is unsatisfactory. Mesenchymal Stem Cells injection may represent~     a new attractive treatment option for anal sphincter lesions. Moreover, experimental injury~     of muscle of anal sphincter in rats has been successfully treated with stem cells injections.~     In this study, the investigators will shed more light on the ability of Mesenchymal Stem~     Cells to induce myogenesis and regenerate anal Sphincter of patients with fecal incontinence.~     It will be very useful to many Egyptian patients.~   "
107447|NCT02160990|"~     The overall goal of this study was to determine the effect of exenatide on gastric emptying,~     satiety and satiation in obese participants. The hypothesis in this study was that exenatide~     retards gastric emptying in obese patients with baseline accelerated gastric emptying.~   "
107448|NCT02160977|"~     If the proprioception of the affected knee post total knee arthroplasty (TKA) can recover~     earlier, it will accelerate the regaining of motion control ability and motion control~     accuracy of the TKA patients. This study compared the proprioception difference of the post~     operation knees between the MIS-QS TKA group and the MIS TKA group.The differences of~     proprioception recovery were analyzed following the two different TKA procedures and the~     advantages of MIS-QS TKA in the recovery of knee. proprioception were discussed.~   "
107449|NCT02160964|"~     Since 2003, that the first retrievable IVC filter was introduced in the U.S,improvements have~     been made in the filter design to resolve problems of structural integrity and increase the~     ability to remove the filter after longer periods of time.The FDA issued a communication in~     August 2010 advising physicians to remove retrievable filters whenever possible and updated~     that letter again in May 2014 due to concerns that these retrievable IVC filters, intended~     for short-term placement, are not always removed once a patient's risk for PE subsides. Known~     long term risks associated with IVC filters include but are not limited to lower limb deep~     vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC~     perforation.~   "
107450|NCT02160951|"~     This is a multi-center, open-label, dose escalation, Phase 1 study of oral LGH447 in Japanese~     patients with relapsed and/or refractory multiple myeloma for which no standard effective~     treatment options exist.~      The study consists of a dose escalation part to estimate the maximum tolerated dose and/or~     the recommended dose for expansion and a dose expansion part to further assess safety and~     preliminary anti-cancer activity of LGH447 at the maximum tolerated dose and/or the~     recommended dose for expansion.~   "
107451|NCT02160938|"~     The objectives of this multi-center collaborative study are to ascertain the frequency of~     specific copy number variants (CNVs) identified prenatally and to evaluate in detail through~     continued follow-up of the children the phenotypes associated with CNVs of known or uncertain~     clinical significance.~   "
107452|NCT02160925|"~     The objective of this study is to investigate the utility of 99mTc-sestamibi SPECT/CT imaging~     for the diagnosis of renal oncocytomas.~   "
107453|NCT02160912|"~     In this observational study insights regarding the tolerability and influence on the quality~     of life of the topical treatment Ectoin Mund- and Rachenspray compared to Emser Pastillen in~     patients with acute Pharyngitis/ Laryngitis under real life conditions shall be gained.~      Patients are treated with Ectoin Mund- & Rachenspray 1% or Emser Pastillen according to the~     demands of the physician and the instructions for use.~   "
107454|NCT02160899|"~     The purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of~     ISIS-APO(a)Rx given to patients with high lipoprotein(a) for 12 weeks.~   "
107455|NCT02160886|"~     A randomized trial investigating if effects of a goal-directed task oriented intervention is~     influenced by who takes the decision and establishes the goal (the child or the parent) and~     whether establishing a goal per se influence performance and goal-achievement. The main~     hypothesis are that children's participation in the goal-setting process would positively~     influence goal achievement, children's self-identified goals would be achievable and that~     both groups would achieve goals that were the target of a goal-directed intervention.~   "
107456|NCT02160873|"~     The purpose of this study is to investigate the influence of a nighttime feeding on next~     morning running performance, hydration status, and exercise metabolism in female endurance~     athletes. Specifically, the effect of a chocolate milk beverage will be examined versus a~     non-nutritive, flavor-matched placebo. The investigators hypothesize that the nighttime~     consumption of chocolate milk, a whole food complex, will result in improved next morning~     running performance versus placebo. Secondarily, the investigators hypothesize that any~     potential positive performance outcomes from the chocolate milk treatment may be due to an~     enhanced pre-exercise hydration status or improved exercise metabolism.~   "
107459|NCT02160834|"~     Greater time spent in sedentary behaviors, independent of physical activity level, can~     increase risk of morbidity and mortality. Objective assessments indicate that bariatric~     surgery patients spend large amounts of time in sedentary behaviors. The present study is the~     first to test whether a mobile health (mHealth) approach that employs widely adopted~     smartphone technology to monitor and modify sedentary behaviors as they occur is a feasible~     and acceptable method of reducing sedentary time in these patients and other obese~     populations.~   "
107460|NCT02160821|"~     Transversus abdominis plane block (TAPB) has emerged as a safe and effective regional~     anesthesia technique for providing postoperative lower abdominal analgesia. Complications~     associated with TAPB are very rare and pose a lower overall risk to the patient receiving a~     TAPB versus a caudal block, which is considered the gold standard for pediatric lower~     abdominal regional anesthesia. Our study hypothesis was that TAPB would be equivalent to~     caudal block initially in providing postoperative pain control but would show improved pain~     relief beyond the anticipated caudal duration.~   "
107461|NCT02160808|"~     Pancreatic leaks complicate pancreatic resection in approximately 20% of cases. The~     pancreatic anastomosis or repair has been referred to as the Achilles heel of pancreatic~     surgery. Unfortunately, despite recognition of this problem and multiple operative techniques~     proposed to prevent this complication, leaks continue to represent a major cause of morbidity~     for patients undergoing pancreatic surgery. Treatment of leaks often requires nutritional~     support with total parenteral nutrition to diminish the leak in addition to invasive~     interventions to contain the leak with drains, stents or in severe cases, reoperation.~     Experiential data suggest that intra-operative infusions of secretin, a naturally occurring~     hormone that stimulates bicarbonate release from the pancreas, following resection but just~     prior to abdomen closure, may identify a leak if present. If secretin can demonstrate~     evidence of leaking intra-operatively, the pancreatic duct leak may be able to be fixed prior~     to abdominal closure. The investigators aim to determine if giving an intra-operative~     infusion of secretin will allow for identification and treatment of leaks after pancreatic~     reconstruction and prior to abdominal closure, leading to a reduction in the rate of~     pancreatic anastomotic leaks requiring intervention. The investigators will perform a~     double-blind, randomized pilot study of 176 patients undergoing pancreatic resection~     (pancreaticoduodenectomy and distal pancreatectomy) at Dartmouth-Hitchcock Medical Center. 88~     of those patients will receive an intra-operative secretin infusion prior to abdominal~     closure and 88 will receive a saline placebo. Our primary outcome of interest will be the~     rate of pancreas duct leaks in each group as measured by the amount of amylase present in the~     surgical drains 5 days following surgery.~   "
107462|NCT02160795|"~     Background:~      - Pregnant women are encouraged to take the vitamin folate. It helps prevent some birth~     defects. Children of mothers who take it also have less risk of some cancers. Between 1993~     and 1995, some women in China took the vitamin daily before and during early pregnancy.~     Another group did not. This study will follow up on children born to both sets of women. (The~     children were born between 1994 and 1996.) Researchers will use these data to study the link~     between folate and cancer in infants and children.~      Objective:~      - To see if folate may reduce childhood cancer if women take it every day before and during~     early pregnancy.~      Eligibility:~      - Mothers who took part in a Chinese folic acid study between 1993 and 1995 and their~     offspring.~      Design:~      - Mothers of children in the study will sign a consent form. The form lets the researchers~     review the child s medical history. They may also review data about their cancer diagnosis.~     The children will also sign a form.~   "
107463|NCT02160782|"~     This is a long-term, open-label study with a double-blind, placebo-controlled, randomized~     drug withdrawal period in children with ALGS designed to evaluate the safety and efficacy of~     LUM001. The study is divided into 5 parts: a 6-week open-label, dose escalation period, a~     12-week stable dosing period, a 4-week randomized, double-blind, placebo-controlled drug~     withdrawal period, a 26-week long-term stable dosing period, and an optional 52 week~     follow-up treatment period for eligible subjects who choose to stay on treatment with LUM001.~     Subjects' participation in the optional follow-up treatment period will continue until the~     first of the following occur: (i) completion of 52 weeks of additional treatment (Week 100),~     or (ii) in the event that a new study of LUM001 opens to enrollment.~   "
107464|NCT02160769|"~     The investigators study aims to capture the objective effects of pterygium surgery on tear~     layer lipid thickness and the tear layer.~      Previous objective studies of the tear film has been limited to corneal staining grading,~     tear break up time and Schirmer's test which have been shown to poor to moderate~     repeatability. The effect of pterygiums on tear layer lipid thickness (LLT) has not~     previously been explored. With the LipiView Ocular Surface Interferometer, the investigators~     have the ability to assess the optical coherence interference pattern produced by light~     reflected off the tear film in a safe and non-invasive manner. Software analysis of the image~     then measures the tear LLT which can be used to objectively quantify the diagnosis of~     lipid-deficient dry eye.~   "
107465|NCT02160756|"~     The purpose of this study is to evaluate the pharmacokinetics (PK - the study of the way a~     drug enters and leaves the blood and tissues over time) and relative bioavailability (the~     extent to which a drug or other substance becomes available to the body) of JNJ-56021927,~     when administered as 3 tablet formulations (test) compared with JNJ-54781532 softgel capsule~     formulation (reference) in healthy male participants under fasted conditions at a single dose~     of 240 milligram (mg).~   "
107466|NCT02160743|"~     This study evaluate the food effect on pharmacokinetics and safety of fixed-dose combination~     of CJ-30056 20/500mg (atorvastatin/metformin XR 20/500mg) in healthy male subjects~   "
107467|NCT02160730|"~     The investigators hypothesize that R-roscovitine will suppress pituitary corticotroph tumor~     ACTH production and normalize urinary free cortisol levels in patients with Cushing disease.~     To date, R-roscovitine has been evaluated in several Phase I and II studies and has shown~     early signs of anti-cancer activity in approximately 240 patients.~   "
107495|NCT02160366|"~     The goal of this laboratory research study is to collect and analyze treatment, molecular~     profiling and biomarker data. The results of the data analysis will be used to better~     understand how to characterize tumors and identify therapies that may be tailored to~     individual patients and to identify and/or predict side effects that may occur and/or predict~     which therapies may be best for participants. Research may also be done on your existing~     tissue to identify new biomarkers.~   "
107468|NCT02160717|"~     Turner Syndrome is a common genetic disorder. Seventy percent of adults with Turner Syndrome~     have abnormalities in glucose metabolism which can lead to diabetes. The current screening~     guidelines for diabetes in Turner Syndrome are not specific and involve a fasting blood sugar~     once a year. The objective of this study is to determine if there are abnormalities in~     glucose metabolism and pancreatic function in young girls with Turner Syndrome. The study~     hypothesis is that pancreatic dysfunction (specifically of the beta cells that make insulin)~     is more prevalent in girls with Turner Syndrome compared to healthy controls.~   "
107469|NCT02160704|"~     This is an exploratory, single center, randomized, parallel, double-blind placebo- and~     active-controlled trial in adult males ages 18 to 35 years of age who have male infertility~     of unknown cause. Approximately 50 men will be randomly assigned to one of two treatment~     groups according to a 1:1 ratio. About half of the men will receive 25mg Androxal and half of~     the men will receive a placebo (non-active pill) for 16 weeks. This study will last~     approximately 4 months and involve up to 7 visits.~      The purpose of this study is to determine the effect the Androxal on sperm production.~   "
107470|NCT02160691|"~     The purpose of the study is to determine if a new device, called the Anxiety Meter, improves~     recognition and management of psychological arousal associated with anxiety in children with~     ASD.~   "
107471|NCT02160678|"~     To compare the safety and efficacy profiles of Tazarotene Cream, 0.1 % to the reference~     listed drug Tazorac® (tazarotene) Cream, 0.1 % in order to demonstrate bioequivalence, and to~     demonstrate superiority of the 2 active creams over that of the cream vehicle (placebo) in~     the treatment of acne vulgaris.~   "
107472|NCT02160665|"~     The purpose of this study is to compare the safety and efficacy profiles of Tazarotene Cream,~     0.05% and Tazorac® (Tazarotene) Cream, 0.05% in order to demonstrate bioequivalence and to~     demonstrate the superiority of the 2 active creams over that of the Vehicle (placebo) in the~     treatment of plaque psoriasis.~   "
107473|NCT02160652|"~     A single center single arm prospective study, assessing the outcome of ureteral~     re-implantation for malignant ureteral obstruction.~   "
107474|NCT02160639|"~     Improving diabetes social support is associated with health improvement benefits. This study~     is a prospective randomized controlled trial comparing the effects of telephone-based~     diabetes self-management support (DSMS) compared with usual care, which includes diabetes~     self-management education (DSME), during a 1-year period. It will determine whether this~     specific model for providing on-going support to people with diabetes will better enable them~     to maintain the engagement in self-care behaviors, clinical improvements and~     diabetes-specific knowledge gained during the course of diabetes self-management education.~   "
107475|NCT02160626|"~     The main objective of this study is to evaluate the dose-response relationship of two~     concentrations of A-101 solution when applied to individual seborrheic keratosis (SK) lesions~     (target lesions) compared with a matching A-101 Solution Vehicle.~   "
107476|NCT02160613|"~     The study hypothesis:~      Is Osteoprotegerin a diagnostic and/or prognostic marker of periodontal disease?~   "
107477|NCT02160600|"~     To compare SBDECT with standard Triple Phase Multi-Detector CT (TPMDCT) in renal mass~     evaluation in terms of appropriateness of treatment received after diagnosis. To determine~     SBDECT diagnostic accuracy.~   "
107478|NCT02160587|"~     This is a safety study to determine the skin sensitization potential of ZuraPrep™ and~     ZuraPrep™ without isopropyl alcohol (IPA) after repetitive patch applications to skin of~     human subjects. Indications of both sensitization and skin irritation will be evaluated.~   "
107479|NCT02160574|"~     This is a safety study to determine the cumulative skin irritation potential of ZuraPrep™ and~     ZuraPrep™ without Isopropyl Alcohol after repetitive patch applications to skin of human~     subjects.~   "
107480|NCT02160561|"~     Lower lobe atelectasis of the lung is common in Acute Respiratory Distress Syndrome (ARDS)~     and has the potential to adversely impact lung compliance and intra-pulmonary shunt. The~     cephalic shift of the diaphragm and dorsal atelectasis associated with the commonly used~     supine position might also contribute to this shunt. Reports indicate that obese patients may~     be more likely to develop dorsal atelectasis than non-obese patients.~      The investigators hypothesized that opening the body position angle at the waist from a~     typical head of bed at 30 degrees to one similar to a more upright reverse trendelenburg~     position, would alter the position of the diaphragm downward, allowing for improved aeration~     of lung bases. Thus, the investigators examined the upright body positioning in mechanically~     ventilated patients with ARDS primarily by evaluating for effects on oxyhemoglobin saturation~     (O2sat), Tidal Volume (TV) and Respiratory Rate (RR).~   "
107481|NCT02160548|"~     We hypothesize that salbutamol will speed removal of alveolar fluid compared to atropine~     alone in OP poisoned patients. We propose to compare the effect of two stat doses of~     nebulized salbutamol (2.5 mg; 5.0 mg), with nebulized saline placebo, in symptomatic patients~     receiving standard resuscitation with atropine, oxygen, and fluids after poisoning with OP~     pesticides. 25 patients will be randomised to each arm (total 75 patients). Primary outcome~     will be oxygen saturation's over the following 60 min during resuscitation. Secondary~     outcomes will include atropine dose administered, speed to stabilization, aspiration or~     pneumonia, intubation, tachydysrhythmias, and mortality. A positive outcome will result in~     design of a large definitive phase III study.~   "
107482|NCT02160535|"~     This study will provide evidence on whether the use of an FDA-approved drug therapy for the~     treatment of chronic migraine (OnabotulinumtoxinA) shows similar efficacy for treatment of~     chronic headaches caused by traumatic injury to the brain (TBI) from a direct hit to the~     head, or a fall, or a motor vehicle accident, or some other traumatic event.~   "
107483|NCT02160522|"~     Our study will measure the pressure of the endotracheal tube cuff in intubated patients in~     the emergency department.~   "
107484|NCT02160509|"~     1. Purpose~             -  This study aims to evaluate the feasibility of iPhone based telementoring for the~               ultrasonography.~        2. Methods~             -  Study Design: Prospective observational study~             -  Study Setting: Urban academic ED of tertiary care teaching hospital~             -  Study period: July, 2014 ~ December, 2014 (six months)~             -  Study participants: Of the patients who need to undergo ultrasonography in the ED,~               those who are agreed to participate in this study are enrolled.~        3. We hypothesize that the iPhone based real time tele-diagnosis by remote expert would not~          be different from the diagnosis via his/her direct ultrasound examination.~   "
107485|NCT02160496|"~     The objective of the study is to assess the effect of diets with different protein~     composition (20%, 27% and 35%), mainly coming from animal proteins such as lean red meat, on~     body weight and lipid profile in overweight and obese women. A dietary intervention is~     carried out during 3 months in 90 women who are individually randomized to an hypocaloric~     diet with three types of macronutrient composition: 1) 35% proteins, 30% fat and 35%~     carbohydrates; 2) 27% proteins, 30% fat and 43% carbohydrates and 3) 20% proteins, 30% fat~     and 50% carbohydrates. Around 50% of total proteins in diet come from lean red meat (leg or~     shoulder of lamb) by providing up to 15 different recipes to participants to use them as part~     of the diet. At the beginning of the study, after 6 weeks and at the end of the intervention,~     the following parameters are determined: anthropometric (weight, waist circumference, body~     mass index and body composition), blood pressure, dietary (72-hours dietary registry) and~     exercise assessments and biochemical analysis (total cholesterol, triglycerides, HDL~     cholesterol, LDL cholesterol, apolipoprotein A1, apolipoprotein B, iron, transferrin,~     ferritin, uric acid, glucose, HbA1c, insulin and adipokines). In 3-months visit, participants~     will be advised to follow the prescribed diets during the next 3 months. Monitoring visits~     with the nutritionist will not be performed. A follow-up visit will be done after 3-months of~     end of intervention (at 6-months after beginning the study) to assess the long-time efficacy~     on main endpoint of each diet. In this visit only anthropometric parameters (weight, waist~     circumference, body mass index and body composition) will be determined.~   "
107486|NCT02160483|"~     Functional magnetic resonance imaging in women with chronic pelvic pain using arterial spin~     labelling, functional connectivity, diffusion tensor imaging and magnetic resonance~     spectroscopy.~   "
107487|NCT02160470|"~     This study tests whether exposure therapy for fear of snakes or spiders is enhanced by the~     addition of a brief fear retrieval trial prior to treatment, and the use of compound~     extinction during treatment. The goal of the study is to determine whether these behavioral~     techniques enhance the efficacy of exposure therapy, one of the most empirically supported~     treatments for anxiety disorders.~   "
107488|NCT02160457|"~     The aim of this study is to test the hypothesis, that improvements in gait pattern following~     individually tailored interventions guided by instrumented 3-dimensional gait analysis are~     superior to those used in 'care as usual'.~   "
107489|NCT02160444|"~     Investigation is designed to determine whether the gold standard for treating anxious youth~     is enhanced by teaching parents to become their anxious child's CBT coach. Children (7-17~     years old) with either Generalized Anxiety Disorder, Social Phobia, or Separation Anxiety~     Disorder are treated with a combination of the Coping Cat Program and a parent-training~     intervention that is designed to teach the child's parents the same cognitive and behavioral~     skills that the child is learning and how to help their child to complete exposure~     activities. The research methods are parallel to those used in the CAMS study so that this~     data can be merged with that data set to evaluate the relative efficacy of the enhanced~     intervention.~   "
107490|NCT02160431|"~     The neuropsychological profiles of children treated with standard CBT for OCD are evaluated.~   "
107491|NCT02160418|"~     In this randomized controlled study, the investigators compare two classes of behavioral~     approaches to change habits and health outcomes with an application to dental health:~     cognitive vs. behavioral financial incentives. Under cognitive incentives subjects are paid~     to correctly answer health-related quizzes. Under behavioral incentives subjects earn money~     for making healthy choices. The investigators apply these incentives to toothbrushing, a~     daily health-related behavior critical to the prevention of dental caries and periodontal~     disease, two high-burden conditions among US adults.~   "
107492|NCT02160405|"~     Nutritional deficiencies can lead to a number of health problems in children. In Latin~     America and the Caribbean countries, are registered so much problems of insufficient~     ingestion of food as of imbalances in the composition of the diet. These latter are expressed~     in the absence of micronutrients (iron, iodine, zinc, vitamin A), becoming a major health~     burden in developing countries. Being the globally's leading risk factor for disease and~     death, with hundreds of millions of pregnant women and young children particularly affected.~      Justification: In Nariño, Colombia higher levels of malnutrition are presented with respect~     to country, just as micronutrient deficiency in children 1 to 4 years is higher than the~     national average. Most of these households are poor families with restrictions on access to~     food sources of these micronutrients, which is reported in a consumption of fruits,~     vegetables, milk products and meat, less than the national average. In this place is~     developing a project that aims to improve potato in higher yield, nutrition and resistance,~     for contribute to increase food security of native communities.~      Objective: Evaluate the effect on iron levels generated by the inclusion of native potato in~     the diet of children aged 2-5 years in institutional beneficiaries modality ICBF, in the~     municipalities of Carlosama, Guachucal, Tuquerres, Cumbal and Pasto. Nariño. Colombia~      Methods:~      Design: A cluster randomized controlled trial. Open label Setting: 6 clusters, municipalities~     of Carlosama, Guachucal, Tuquerres, Cumbal and Pasto (two towns), which will be randomly~     assigned to 2 groups: the treatment group that receives native potato, and the control group~     that receives traditional potato, that will be include in the usual Institution meal~     Participants: children from 2 to 5 years, beneficiaries of programs in institutional modality~     of ICBF, in the municipalities of Carlosama, Guachucal, Tuquerres, Cumbal and Pasto.~      Main outcome measures: serum ferritin and transferrin levels~      The study was conducted in the form of institutional programs ICBF, in the municipalities of~     Carlosama, Guachucal, Túquerres, Cumbal and Pasto. Colombia. One hypothesis to a queue based~     on the changes that occur over time after surgery in the mean values (μ) of serum ferritin in~     the treatment group compared with the control group. A sample size of 212 children were~     calculated. The study has been presented and approved by the Ethics Committee of the Faculty~     of Medicine of the National University of Colombia and the Institutional Review Board of the~     participating institution. All parents of participating children must sign a written form to~     accept the voluntary participation of their child in the study.~   "
107493|NCT02160392|"~     The female upper genital tract is a unique compartment involved in HIV pathogenesis.~   "
107494|NCT02160379|"~     This is a cross-sectional study enrolling~        -  11 weight-stable, formerly obese female patients 1-5 years after Roux-en-Y gastric~          Bypass (RYGB)~        -  11 age- and weight-matched female subjects~        -  10 normal weight (Body Mass Index 19-25 kg/m2) subjects The following measurements will~          be performed in each participants in basal conditions (after an overnight fast) and~          after ingestion of a standard meal~        -  electroencephalographic recordings of visually evoked potential after presentation of~          food- or non-food pictures~        -  plasma concentration of metabolites (glucose, fatty acids), glucoregulatory hormones~          (insulin, glucagon), gastro-intestinal hormones (Gastric Inhibitory Polypeptide (GIP),~          Glucagon-like Peptide-1 (GLP1), ghrelin,Cholecystokinin (CCK), and bile acids Aims of~          this observational study are~        -  to evaluate the effects of RYGB on brain perception of food related visual stimulation~        -  to search for relationships between RYGB effects on brain responses and~          gastro-intestinal hormone secretion~   "
107496|NCT02160353|"~     The role of this study is to focus on the potential role of abiraterone acetate in~     treatment-naive patients newly diagnosed with high-risk localised prostate cancer requiring~     combined hormonal therapy and radiotherapy.~   "
107498|NCT02160327|"~     The specific aims of the the investigators studies are as follows:~        -  To collect the tear samples from patients with different ocular surface disorders,~          including SLK, conjunctivochalasis, and keratoconjunctivitis sicca (KCS).~        -  To evaluate the differential expression of tear cytokines and pH values between~          different ocular surface disorders.~        -  To collect the surgical conjunctival specimens from the patients with SLK and~          conjunctivochalasis.~        -  To evaluate the factors inducing mast cell migration and how mast cell is activated in~          SLK via surgical specimens and cultivated fibroblast.~   "
107499|NCT02160314|"~     This study will evaluate the safety of the pessary device by objective evaluation of vaginal~     wall integrity and subjective assessment of comfort during in-use conditions.~   "
107500|NCT02160301|"~     The study is a prospective, randomized, open-label comparison of a multimodal regimen and a~     standard, narcotic-based regimen for postoperative pain control in patients undergoing~     surgery for an operatively indicated, isolated extremity fracture. The investigators will be~     measuring pain levels, narcotic use, patient satisfaction, patient reported function, adverse~     events and fracture union. The investigators hypothesize that this multimodal regimen will~     lead to improved pain, less narcotic use and improved satisfaction as compared to the~     standard regimen.~   "
107501|NCT02160288|"~     The purpose of this study is to determine if Botulinum Toxin-A (Botox) injection will improve~     symptoms of constipation in obstructed defecation syndrome (ODS).~   "
107502|NCT02160275|"~     In previous studies, we tested the feasibility of a bi-hormonal closed loop system. This~     system for automated control of blood glucose in patients with type 1 diabetes was tested in~     the clinical research center as well as at the home of the patients. Glucose control with~     automated closed loop control was comparable to patient-managed open loop control.~      The closed loop system has been further developed and miniaturized (from backpack to~     smartphone size) in order to interfere as little as possible with daily patient life. The aim~     of this trial is to assess the efficacy of the new prototype at the home of the patient. It~     is hypothesized that the closed loop system provides better glucose control than standard~     open loop therapy.~   "
107503|NCT02160262|"~     To evaluate the long-term safety and tolerability of SEP 225289 in adult subjects with~     Attention Deficit Hyperactivity Disorder (ADHD)~   "
107504|NCT02160249|"~     The purpose of this study is to determine whether community-based rehabilitation plus~     facility-based care is superior to facility-based care alone in reducing disability related~     to schizophrenia in rural Ethiopia.~   "
107505|NCT02160236|"~     In this study the investigators aimed to compare of postoperative analgesic effects of~     intravenous dexketoprofen trometamol and tenoxicam in lumbar disc surgery.~   "
107506|NCT02160223|"~     Incomplete recovery of neuromuscular function after surgery can lead to respiratory~     complications. Patients with obstructive sleep apnea (OSA) are prone to respiratory~     complications after surgery. Neostigmin and sugammadex are used for neuromuscular reversal.~      The aim of this study was to compare sugammadex and neostigmin regarding efficacy, incidence~     of respiratory complications and cost in patients undergoing surgery for OSA~   "
107507|NCT02160210|"~     This study is the evaluation of ultrafine endoscope (with small caliber and turning radius~     )for colonoscopy in decreasing abdominal pain of patients . 60 patients will be accepted in~     this trial.~   "
107508|NCT02160197|"~     The purpose of this study is to examine the effect of variations in practice, ranging from~     early functional rehabilitation to complete immobilsation in post operative patients with~     ankle fixation following fractures. The primary goal of any post-operative regimen is to~     attain full weight-bearing and as close to pre-injury levels of activity as soon as possible.~      We seek to establish the effect on (1) functional outcome, (2) complication rates and (3)~     time to return to work of three different approaches to rehabilitation after ankle fracture~     fixation in order to produce a standardised, evidence-based guideline for our unit. We also~     aim to perform a cost analysis for each approach.~   "
107509|NCT02160184|"~     The aim of the study is to assess the efficacy and safety of a closed-loop system consisting~     of a predictive rule-based algorithm integrated on the Medtronic Portable Glucose Control~     System (PGCS) in patients with type 1 diabetes for controlling the nocturnal and~     post-breakfast periods. Intervention will be to apply the automated closed-loop system by~     administering a subcutaneous insulin microbolus every 5 minutes depending on reading from a~     continuous glucose measurement (CGM) system.~   "
107510|NCT02160171|"~     A Multicentre Clinical Evaluation of a Decision Support Algorithm for Neonatal Seizure~     Detection: ANSeR~   "
107511|NCT02160158|"~     The purpose of this study is to evaluate the relative bioavailability of 2 new~     bead-in-capsule formulations compared to the commercial extended-release formulation (both~     fed and fasted) and to assess the effect of sprinkling the capsule contents on applesauce on~     the pharmacokinetics of 5 hydroxymethyl tolterodine (5-HMT).~   "
107512|NCT02160145|"~     The purpose of the study is to determine whether tolvaptan is effective and safe for the~     treatment of late-stage chronic kidney disease due to autosomal dominant polycystic kidney~     disease (ADPKD)~   "
107513|NCT02160132|"~     This prospective, randomized, controlled, multi-center clinical trial will evaluate the~     effect and security of steroids therapy for patients of IgA nephropathy with active~     pathological changes,including crescents,necrosis and microthrombus.~   "
107514|NCT02160119|"~     Several studies seem to indicate that emotional attention and change-related attention are~     impaired in ASD. The goal of this study is to identify the relationships between those two~     types of automatic attention in visual and auditory modalities in subjects with ASD compared~     to healthy controls and also, over the course of development (children, adults). In order to~     achieve this goal, the investigators will use complementary techniques (EEG and MRI-based~     techniques (fMRI, DTI)).~   "
107515|NCT02160106|"~     The phase I dose escalation study will investigate the safety, tolerability, and~     pharmacokinetics of the TGF-β pathway inhibitor TEW 7197 in subjects with advanced,~     refractory solid tumors.~   "
107531|NCT02159898|"~     This is a prospective, single blinded, randomized study of EndoMAXX EVT Fully Covered~     Esophageal Stent with Valve for the treatment of malignant strictures of the lower esophagus.~     The purpose of this study is to evaluate improvement of dysphagia due to esophageal stricture~     with EndoMAXX EVT Fully Covered Esophageal Stent with Valve (investigational device) compared~     to the EndoMAXX Fully Covered Esophageal Stent (reference device).~   "
107516|NCT02160093|"~     Pursuant to our previous longitudinal study (ClinicalTrials.gov ID: NCT02073370) in geriatric~     outpatients cooperated with the Department of Family Medicine, Department of Geriatrics and~     Gerontology, National Taiwan University Hospital, this study will be conducted to examine the~     impacts of the specific co-morbidities and ageing psychology on the outcomes of~     frailty/sarcopenia syndrome. The thresholds of specific chronic disease will be reviewed~     after frailty being considered in the elderly with co-morbidity condition. In addition, the~     conceptual framework and corresponding measuring instrument of mental frailty will be~     expected developed.~   "
107517|NCT02160080|"~     End-stage liver disease due to hepatitis C virus (HCV) is the most common indication for~     liver transplantation(LT) worldwide (30~40%). Within 5 years, about 25-30% of liver~     transplant recipients with recurrent hepatitis C would progress to liver cirrhosis (Ponziani~     et. Al, 2011), it also accounts for 2/3 of graft failure and deaths after liver~     transplantation.(Bzowej et al., 2011)~      Kaohsiung Chang Gung Memorial Hospital continue to have at least 45 HCV-related liver disease~     patients awaiting for liver transplantation annually. If the HCV viral load can be~     significantly reduced or sustained virologic response (SVR) can be achieved by triple therapy~     with Pegylated interferon alfa(PEG)/Ribavirin(RBV)/Boceprevir(BOC) treatment before liver~     transplantation(LT), the graft re-infection of HCV can be prevented. By this way, we can~     reduce the risk of early fibrosis progression in the liver graft, and hopefully, improving~     graft and patient survival after liver transplantation.(Toniutto, 2008)(Ponziani et al,~     2011).~      We aim to conduct an prospective, open label, single arm study. This study design is single~     arm to treat HCV patients with Pegylated interferon alfa(PEG)/Ribavirin(RBV)/Boceprevir(BOC)~     triple therapies before liver transplantation for patients with detectable HCV RNA. The total~     number of patients would be around 20 cases included in the study and all of them will take~     Pegylated interferon alfa(PEG)/Ribavirin(RBV)/Boceprevir(BOC) triple therapy. The~     experimental regimen contains 4 week lead-in therapy with Peg-Interferon α-2b plus Ribavirin.~     Then after, triple therapy with Boceprevir + Peg-Interferon α-2b + Ribavirin will be used for~     at least 16 weeks or maximal 44 weeks before transplantation. Normal practice based on the~     treatment protocol of the Kaohsiung Chang Gung Memorial Hospital liver transplant center will~     be done before enrollment. Patients will be monitored for all the efficacy and safety~     endpoints during the treatment period. HCV RNA will be checked at time of transplant.~     Finally, patients will received regular monitoring of HCV RNA 1, 3, 6, 9, 12 months after~     liver transplantation.~   "
107518|NCT02160067|"~     The purpose of this study is to obtain pharmacokinetic data for a dose proportionality and~     relative bioavailability assessment of 2nd generation BTDS patches compared to 1st generation~     BTDS patches.~   "
107519|NCT02160054|"~     To evaluate the safety and efficacy of Graceptor ® in patients with kidney transplantation~     when converted from cyclosporine~   "
107520|NCT02160041|"~     The purpose of this signal seeking study is to determine whether treatment with BGJ398~     demonstrates sufficient efficacy in select FGFR pathway-regulated solid tumors and/or~     hematologic malignancies to warrant further study.~   "
107521|NCT02160028|"~     Information about the effectiveness of treatment has been found to reduce pain, termed~     placebo analgesia. In this study it will be investigated whether this finding translates to~     the dental clinic. It will be investigated whether information that suggested that minimal~     pain will be experienced during filling therapy, can reduce the pain associated with that~     procedure compared to a group that receives standard information. All patients will receive~     the same amount of anesthesia and similar procedures during filling therapy. It is predicted~     that extended information should reduce pain, and that the reduction in pain should be~     associated with a reduction in stress.~   "
107522|NCT02160015|"~     This phase I trial studies the side effects and best dose of lenalidomide when given together~     with ibrutinib and rituximab in treating patients with chronic lymphocytic leukemia or small~     lymphocytic lymphoma that has come back, has not responded well to prior treatments, has~     spread to other parts of the body, or cannot be removed by surgery. Biological therapies,~     such as lenalidomide, use substances made from living organisms that may stimulate or~     suppress the immune system in different ways and stop cancer cells from growing. Ibrutinib~     may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~     Monoclonal antibodies, such as rituximab, may find cancer cells and help kill them. Giving~     lenalidomide together with ibrutinib and rituximab may kill more cancer cells.~   "
107523|NCT02160002|"~     The objective of this proposal is to evaluate whether weaning from an incubator to a crib at~     lower versus higher weight, 1600g or 1800g will result in shorter length of hospital stay~     among moderately preterm infants.~      The hypothesis of this study is that length of hospital stay (from birth to discharge) will~     be decreased among moderate preterm infants weaned from an incubator to an open crib at a~     lower versus higher weight, 1600g vs. 1800g.~   "
107524|NCT02159989|"~     This phase I trial studies the side effects and best dose of sapanisertib and ziv-aflibercept~     in treating patients with solid tumors that have come back and have spread to another place~     in the body or cannot be removed by surgery. Sapanisertib may stop the growth of tumor cells~     by blocking some of the enzymes needed for cell growth. Ziv-aflibercept may stop the growth~     of solid tumors by blocking the growth of new blood vessels necessary for tumor growth.~     Giving sapanisertib with ziv-aflibercept may kill more tumor cells.~   "
107525|NCT02159976|"~     1. To compare 10-day sequential therapy and 14-day modified bismuth quadruple therapy and~          to establish more effective first-line regimen for the eradication of Helicobacter~          pylori in Korea.~        2. To evaluate the effect of H. pylori eradication therapy on the symptom improvement of~          functional dyspepsia~   "
107526|NCT02159963|"~     The investigators aim to investigate the effect of high-intensity training in patients with~     facioscapulohumeral muscular dystrophy. Can patients benefit from this type of exercise~     without muscle damage.~   "
107527|NCT02159950|"~     This randomized phase II trial studies how well sipuleucel-T with or without tasquinimod~     works in treating patients with hormone-resistant prostate cancer that has spread to other~     parts of the body. Vaccines made from a person's tumor cells and white blood cells may help~     the body build an effective immune response to kill tumor cells. Tasquinimod may stop the~     growth of prostate cancer by blocking the growth of new blood vessels necessary for tumor~     growth. It is not yet known whether sipuleucel-T is more effective with or without~     tasquinimod in treating prostate cancer.~   "
107528|NCT02159937|"~     The purpose of this study is to evaluate in vitro the potential of peptides, to modify,~     phenotypically and functionally, the monocyte-derived dendritic cells of patients with~     metastatic cancer.~   "
107529|NCT02159924|"~     This study aims to investigate posture-mobility associations in the upper quadrant by means~     of smartphone measurements~   "
107530|NCT02159911|"~     A randomized, double blind study to compare 200 and 400 mcg misoprostol for cervical~     preparation before hysteroscopy.~   "
123377|NCT01952574|"~     Randomized, double-blind, placebo-controlled, parallel-group, multi-center study followed by~     open-label phase. To evaluate the effect of AMG 334 compared to placebo on the change from~     baseline in monthly migraine days~   "
107532|NCT02159885|"~     Automatically titrating continuous positive airway pressure (APAP) and continuous positive~     airway pressure (CPAP) are considered first-line treatments for obstructive sleep apnea.~     There is a growing body of evidence that suggests that early patient education and~     intervention may improve adherence with positive airway pressure. The investigators plan a~     prospective, randomized trial to see if telemonitoring in the first several weeks of PAP~     therapy improves adherence following 3 months of treatment.~   "
107533|NCT02159872|"~     The goal of this clinical research study is learn if omacetaxine can help to control~     myelodysplastic syndrome (MDS). The safety of this drug will also be studied.~      This is an investigational study. Omacetaxine is FDA approved and commercially available for~     the treatment of chronic myelogenous leukemia (CML). It is investigational to use omacetaxine~     in patients with MDS. The study doctor can explain how the study drug is designed to work.~      Up to 80 participants will be enrolled in this study. All will take part at MD Anderson.~   "
107534|NCT02159859|"~     The purpose of this study is to determine the amount of ertapenem in the blood over time~     between hemodialysis session.~   "
107535|NCT02159846|"~     The aim of this study was to evaluate the effects of mixed herbs as ad-on therapy on blood~     sugar and lipid profile of patients with established T2DM. A total 20 patients were consented~     and were equally divided into the Control and the Test groups and was fed with the Placebo or~     mixed herbs 4 g daily for 30 days, respectively. Blood samples were collected before and at~     the end of the feeding period and analyzed for the parameters namely Fasting Blood Sugar~     (FBS), 2 hours post prandial (2HPP) Glycosylated Hb (HbA1c) and Lipid Profile. The collected~     data was analyzed using SPSS Statistical Software version 12.~   "
107536|NCT02159833|"~     The investigators will conduct low-dose intranasal allergen challenges on~     children/adolescents with a diagnosis of food allergy to egg/cow's milk/soya/wheat/peanut.~     The data will be used to determine the safety and potential utility of intranasal food~     challenges in the diagnosis of food allergy.~   "
107537|NCT02159820|"~     Ovarian cancer is the most lethal gynecological cancer and the 5th leading cause of cancer~     death in women. Most patients are typically diagnosed with advanced-stage disease.~     Platinum-paclitaxel regimen has been widely adopted as a standard first-line treatment for~     advanced ovarian cancer. Multiple collaborative randomised phase III trials evaluating the~     addition of a third chemotherapy agent, maintenance therapy or alternative taxanes failed to~     demonstrate significant improvements over a standard carboplatin/taxane doublet.~      Decitabine (DAC), one major DNA demethylating agent, has been approved for treatment of~     preleukemic hematological disease myelodysplastic syndrome (MDS) by the Food and Drug~     Administration. Past trials of these with high doses, i.e., the use of maximal tolerated~     dose, for patients with solid tumors showed a low therapeutic index, due to extreme~     toxicities that have probably confounded the ability to document the true clinical response.~      Low dose DNA demethylation agent decitabine (DAC) can resensitize the therapeutic indexes of~     resistent ovary cancer cells in vivo and in vitro.~      The investigators hypothesized that DAC-triggered epigenetic reprogramming of tumor cells and~     possible immune cells could induce pronounced long-dated clinical effect by~     chemosensitization- and immunopotentiation-driven maximal eradicating roles on the~     minimal/residual lesions in primary patients with poor prognosis.~   "
107538|NCT02159807|"~     The purpose of this study is to determine what dose of medication administered through a~     combined spinal epidural (CSE) provides the optimal pain relief with the minimal amount of~     side effects. The 3 doses studied here (1.25, 1.66 and 2.5mg) are routinely use on the labor~     floor (depending on the physician preference) but the idea is to quantify safety, efficacy~     and side effects for each of these doses.~   "
107539|NCT02159794|"~     The purpose of this study is to evaluate the safety and performance of the HLT System in~     patients with severe aortic stenosis who present at High Risk for aortic valve replacement~     surgery.~   "
107540|NCT02159781|"~     The investigators plan to recruit 40 healthy patients referred to the unit of Periodontology,~     diagnosed with generalized moderate - severe chronic periodontitis.~      treatment will include 4 - 6 sessions of scaling + root planning, oral hygiene instructions~     and motivation.~      Whole saliva will be collected at intake and 8 - 14 weeks post periodontal treatment.~      Saliva will be analyzed for trans locator protein. Study hypothesis: Periodontal treatment~     has an affect on saliva components.~   "
107541|NCT02159768|"~     The Airtraq is a battery powered single use optical laryngoscope with a channel to hold and~     guide the tracheal tube into the trachea. It enables tracheal intubation in patients with~     normal and difficult airways, by enabling laryngoscopy without neck movement. As a single use~     device, it is cost effective to have these placed in emergency equipment kits, and for use by~     emergency and military personnel.~      However, it does have several limitations. The Airtraq requires the user to place his/her eye~     to the eyepiece in order to see the advancement of the laryngoscope and the tracheal tube,~     which may be difficult if the patient is on the ground or in emergency scenarios. Only the~     user can see through the eyepiece and any assistants are unable to view the larynx, this~     makes it difficult for assistants to help the operator.~      Many handphones now incorporate high quality cameras. In this study, we will evaluate the~     effectiveness of using the iPhone to aid laryngoscopy with the Airtraq optical laryngoscope~     during laryngoscopy and intubation in 30 patients presenting for elective surgery under~     general anaesthesia. We have manufactured an attachment that fits over the eyepiece of the~     Airtraq, to hold an iPhone to the eyepiece. This will enable to operator and assistants to~     simultaneously view the insertion of the Airtraq, view the larynx and view the passage of the~     tracheal tube into the trachea.~   "
107542|NCT02159755|"~     This phase I trial studies the side effects and best dose of ibrutinib and palbociclib in~     treating patients with previously treated mantle cell lymphoma. Ibrutinib and palbociclib may~     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~     Palbociclib may also help ibrutinib work better by making cancer cells more sensitive to the~     drug.~   "
107553|NCT02159612|"~     An investigation of disease progression in adult danish patients with facioscapulohumeral~     muscular dystrophy. The disease progression is followed for a year with two test-days,~     including functional muscle tests and a MRI scan of muscles in the back and legs.~   "
108538|NCT02146768|"~     Low-dose-contrast CCTA can effectively and safely assess the aortic valve apparatus, and~     effectively direct the trans-catheter heart valve (THV) size selection by providing accurate~     annulus sizing, and provide adequate pre-procedural risk-stratification guidance for~     TAVR/TAVI.~   "
107543|NCT02159742|"~     From 1996-present, we have used photodynamic therapy (PDT) to treat a number of neoplastic~     diseases both on prospective research protocols (for head and neck cancer, pleural~     malignancies, peritoneal carcinomatosis or sarcomatosis and prostate cancer) as well as for~     FDA approved and off label or compassionate exemption indications (neoplasms of the skin,~     bronchus, esophagus, head and neck and pleura). The goal of this treatment is to maximize~     quality of life and organ function while minimizing the chance of tumor recurrence. As such,~     we would like to retrospectively review the treatment parameters of all patients who~     undergo/underwent PDT (including operative notes and photodynamic therapy records) and~     treatment outcomes (including all organ functions, performance status, tumor recurrence,~     laboratory values and any other data present in the routinely documented follow up visits).~     For patients who have died or were lost to follow-up prior to initiation of this study, a~     retrospective review of available data will be performed. For patients who are still being~     actively followed after PDT or who receive PDT after the initiation of this study, informed~     consent will be obtained for obtaining continued follow-up data prospectively and any~     previous data will be collected retrospectively.. These subjects will continue to receive~     care from their current physicians according to standard medical practice and no attempt will~     be made to alter the types of follow-up, radiologic or other diagnostic studies or medical~     treatment as a result of enrollment in this study. All data will be de-identified and added~     to our already existing PDT treatment outcome databases for outcomes analysis, quality~     improvement and reporting of results in abstract and manuscript forms.~   "
107544|NCT02159729|"~     Long-term follow-up study of subjects who completed Kythera-sponsored trials of ATX-101~     (06-03, 07-07, 09-15)~   "
107545|NCT02159716|"~     Phase I study to establish safety and feasibility of intravenously administered lentiviral~     transduced CART-meso cells administered with and without cyclophosphamide in a 3+3 dose~     escalation design in patients with metastatic pancreatic cancer, serous epithelial ovarian~     cancer, or pleural mesothelioma. Dose: 1-3xE7 /mE2 (Cohort 1 and 2) and 1-3xE8 /mE2 (Cohort 3~     and 4 ) CAR+ T cells by intravenous route. In the event of 2 DLTs at each dose level, we will~     dose deescalate by 10-fold.~   "
107546|NCT02159703|"~     To determine 2-year local (primary tumor site) control and toxicity rates in patients~     receiving adjuvant RT post-TORS, omitting the primary tumor bed, in patients with completely~     resected, HPV-positive SCCA of the oropharynx.~      To determine acute and long-term toxicity rates in patients receiving adjuvant RT post-TORS,~     omitting the primary tumor bed, in patients with completely resected, HPV-positive SCCA of~     the oropharynx.~   "
107547|NCT02159690|"~     This study investigates the pathologic effects of the combination of enzalutamide,~     abiraterone acetate, dutasteride, and degarelix when given for 12 weeks prior to~     prostatectomy in men with localized prostate cancer.~      Enzalutamide, an androgen receptor (AR) antagonist, blocks binding of testosterone to the AR~     as well as preventing nuclear translocation of the AR and DNA binding. Abiraterone acetate~     inhibits the CYP17 pathway, which is involved in the formation of androgens. Dutasteride is a~     5-alpha-reductase inhibitor which blocks conversion of testosterone to dihydrotestosterone.~     Degarelix, a gonadotropin-releasing hormone (GnRH) antagonist, binds to GnRH receptors on the~     pituitary gland thus suppressing testosterone release from the testes.~      Therefore it is hypothesized that the combination of enzalutamide, abiraterone acetate,~     dutasteride, and degarelix will result in near-complete AR inhibition and produce favorable~     pathologic changes after 12 weeks of therapy.~   "
107548|NCT02159677|"~     The purpose of this study is to assess neck and low back pain using Electrical Impedance~     Myography (EIM) in order to develop an algorithm to aid primary care providers (PCPs) in the~     diagnosis of neck/back pain. Secondary goals include the refinement of EIM technology and~     associated software of ease-of-use and interpretation by PCPs and staff.~   "
107549|NCT02159664|"~     Didgeridoo practice has been shown to improve OSA severity. The aim of our study is to assess~     the changes in upper airways obstruction levels before and after Didgeridoo practice in~     moderate OSA patients.~   "
107550|NCT02159651|"~     This study is to evaluate the safety and the efficacy of Prograf in patients with~     interstitial pneumonia associated with polymyositis / dermatomyositis in acute clinical~     setting.~   "
107551|NCT02159638|"~     Continuous glucose monitoring (CGM) is a tool used in the treatment of patients with type 1~     diabetes. A continuous glucose monitor (CGM) is a subcutaneous tissue sensor, which provides~     a tissue fluid glucose measurement every 1 to 5 minutes. Since CGM measure the glucose level~     by a sensor in subcutaneous tissue, there is uncertainty in the estimation of blood glucose~     levels. The accuracy of a certain CGM system can be assessed by comparing the glucose levels~     estimated by CGM with measured glucose levels in plasma. In the current study, we will~     compare the accuracy of the 2 CGM systems available on the market for clinical use in~     patients with type 1 diabetes. The aim of the current study is to evaluate effectiveness,~     safety and treatment satisfaction with 2 different CGM systems among adult type 1 diabetic~     patients.~   "
107552|NCT02159625|"~     Hemodialysis (HD) patients with end stage renal disease (ESRD) experience higher rates of~     cardiovascular (CV) morbidity and mortality than do the general population and many~     populations with other chronic diseases. This exceptional risk is explained in part by known~     risk factors, such as diabetes, hypertension, and other uremia-related factors, including~     vascular calcification and stiffness, autonomic dysfunction, and a high burden of circulating~     inflammatory mediators. Recent studies suggest that blood pressure variability, especially~     intra-dialytic hypotension (IDH) is the most significant risk factor for these CV events.~     Studies have also shown that the use of IAB is capable of improving cardiovascular function~     for avoiding or minimizing the development of an orthostatic hypotensive episode (OHE) in~     patients with autonomic dysfunction, orthostatic hypotension (OH) in diabetes patients and~     children with orthostatic intolerance, and post-dialytic orthostatic hypotension (PDOH).~      The investigators propose a study to examine the use of an abdominal compression elastic~     support (ACES) to prevent the development of IDH in patients who are known to be prone to~     these episodes. The ultimate goal is to facilitate more effective and safer dialysis therapy.~     The ACES has a configuration that is similar to a back-support work belt or an inflatable~     abdominal band (IAB). All of these devices are wrapped around to compress the abdomen at the~     waist.~   "
123378|NCT01952561|"~     Study will evaluate the vaginal and blood pharmacokinetics of dapivirine from a vaginal ring~     containing 25 mg worn for 1, 2, 4, 8 or 12 months.~   "
107556|NCT02159573|"~     The primary objective of the study is to evaluate relapse activity, as measured by the~     proportion of participants relapsed at 12 months, in participants with relapsing-remitting~     multiple sclerosis (RRMS) who transition from Tysabri (BG00002) to Tecfidera (BG00012) in the~     real-world setting. The secondary objective is to further evaluate relapse activity, defined~     as annualized relapse rate (ARR), hospitalization and intravenous corticosteroid use, during~     the first year of Tecfidera treatment following transition from Tysabri treatment.~   "
107557|NCT02159560|"~     The investigators hypothesize that multi-port thoracic epidural catheters will provide~     superior pain relief when compared to uniport catheters for post-surgical patients.~   "
107558|NCT02159547|"~     H0 hypothesis: IV dexketoprofen is equivalent to placebo in ceasing migraine attack in~     emergency department.~      H1 hypothesis: IV dexketoprofen is not equivalent (superior) to placebo in ceasing migraine~     attack in emergency department.~   "
107559|NCT02159534|"~     Background : Brain vulnerability is particularly marked in preterm neonates and has long-term~     consequences. Unlike lesions affecting other organs, those that affect the brain can~     currently not 'be repaired' by producing new cells. However, exeprience-driven brain~     plasticity allows the brain to reorganise its connections to compensate (at least partially)~     the effects of an injury.~      Purpose : To evaluate the influence of Primebrain stimulation programme administred by~     parents until 6 months post-term on motor and neurophysiological development of infants born~     <32 weeks' gestation or with birth weight <1500 g.~   "
107560|NCT02159521|"~     To evaluate the efficacy of ultrasound accelerated thrombolysis using the EkoSonic®~     Endovascular System with standard infusion of thrombolytic drug for post-thrombotic syndrome~     and chronic venous occlusion.~   "
107561|NCT02159508|"~     The purpose of this study is to assess the effect of a pre-planned patient-adjusted intensive~     nutritional counselling given by a dietitian several times during (chemo)radiotherapy vs.~     individualized nutritional counselling given by a dietitian once in the beginning of~     (chemo)radiotherapy and thereafter on-demand in patients with head and neck squamous cell~     cancer.~   "
107562|NCT02159495|"~     This phase I trial studies the side effects and the best dose of genetically modified T-cells~     after lymphodepleting chemotherapy in treating patients with acute myeloid leukemia or~     blastic plasmacytoid dendritic cell neoplasm that has returned after a period of improvement~     or has not responded to previous treatment. An immune cell is a type of blood cell that can~     recognize and kill abnormal cells in the body. The immune cell product will be made from~     patient or patient's donor (related or unrelated) blood cells. The immune cells are changed~     by inserting additional pieces of deoxyribonucleic acid (DNA) (genetic material) into the~     cell to make it recognize and kill cancer cells. Placing a modified gene into white blood~     cells may help the body build an immune response to kill cancer cells.~   "
107563|NCT02159482|"~     This research study is for people who have previously received cancer vaccines. The~     investigators are testing a form of therapy known as interferon alfa-2a, which is~     commercially available as the drug Roferon®-A, to see if it can be used to help boost the~     effects of the cancer vaccine and help the immune system attack the cancer.~      It is believed that the body's immune system can attack tumor cells and kill them. This is~     thought to be due to immune cells called T cells which can recognize special proteins on the~     surface of tumors as a signal to fight the cancer. However, the vaccine may not work very~     well if the protein signal is too weak for the T cells to find your tumors. The investigators~     think that interferon alfa-2a can signal the cancer cells in the body to make more proteins~     that may allow the T cells to recognize and kill the cancer cells better.~   "
107564|NCT02159469|"~     Evaluation of efficacy and safety of testosterone enanthate administered subcutaneously using~     an auto-injector~   "
107565|NCT02159456|"~     1. Nutritional support during critical illness is important to improve the clinical outcome~          of patients. Recently, the apply of early enteral nutrition is recommend in critically~          ill patients on basis of data that enteral nutrition can be helpful to prevent the~          hospital-acquired infections.~             -  However, in critically ill patients, the smooth progress of nutritional support is~               often hindered by gastrointestinal intolerance, underlying clinical condition, and~               temporal necessity of procedure or operation.~             -  Continuous feeding method, compared with intermittent feeding, is expected to~               reduce the risk of gastrointestinal intolerance, and improve the nutritional~               support, but this hypothesis is not supported by appropriate evidences.~        2. We will elucidate to compare the efficacy and safety of the continuous feeding method in~          critically ill patients, compared with the intermittent feeding method.~             -  Prospective, randomized controlled study~             -  Primary outcome: the achievement rate of target nutritional goal within 7 days~               after the start of enteral nutrition~             -  Secondary outcome: gastrointestinal tolerance, In-ICU/hospital mortality, frequency~               of hospital-acquired infection, ICU/hospital length-of-stay, duration of mechanical~               ventilation~   "
107566|NCT02159443|"~     Hu14.18K322A is a monoclonal antibody developed at St. Jude Children's Research Hospital~     (SJCRH) that is made to bind to cancer cells that have a molecule called GD2 on their~     surface. Sometimes the human body will make an antibody to the therapeutic antibody (like~     hu14.18K322A) that is being given for treatment. These are called human anti-human antibodies~     (HAHA). When testing for HAHA in a previous cohort of patients who received hu14.18K322A, it~     was found that some patients tested positive for high levels of an antibody before receiving~     hu14.18K322A or any other anti-GD2 antibody. In this study, investigators would like to know~     more about the nature of this pretreatment antibody, how often is it present, and if in the~     laboratory it increases the killing of tumor cells.~      OBJECTIVES:~        -  To determine whether pretreatment anti-therapeutic antibodies (PATA) represent~          antibodies reactive against an epitope (allotypic determinant) found on the anti-GD2~          antibody hu14.18K322A~        -  To determine if PATA increases the anti-tumor efficacy of anti-GD2 antibodies in vitro~   "
107597|NCT02159040|"~     The primary objective of the study is to compare the overall response rate (inclusive of~     complete response, partial response and hematologic improvement) per IWG 2006 criteria in~     patients with higher risk MDS treated with azacitidine with or without deferasirox achieved~     over the course of one year. Hematologic improvement must be maintained for at least 8 weeks.~   "
123379|NCT01952548|"~     This study will test single doses of the study drug in increasing amounts to see if it is~     safe.~   "
107567|NCT02159430|"~     Since 1963 Hereditary AngioEdema (HAE) is considered an autosomal dominant disorder~     (Donaldson and Evans), characterized by a quantitative and/or qualitative deficit of C1~     esterase inhibitor (C1-INH), which affects approximately 1:50.000 individuals in the general~     population. From this period the link between HAE and psychiatry was interrupted, however~     genetic issues could not comprehensively explain the clinical evolution of the disease.~     Clinical studies show an evident gap between genotype and phenotype of HAE. For this still~     controversial question, we have designed this cross-sectional study in order to establish the~     relationship between HAE clinical manifestations and neurobiological/psychopatological~     parameters.~   "
107568|NCT02159417|"~     A lot of data show that therapeutic education is beneficial for diabetic patients. In the~     French jails, there are very few programs of therapeutic education while this population is~     usually precarious with no access at care sector before the jail.~      The purpose of this study is to determinate if the therapeutic education of the diabetic~     patients is possible in the Paris jail La Santé.~   "
107569|NCT02159404|"~     Nasal mucus as first line defense barrier of the nasal mucosa contains a variety of proteins~     that act as functional units. We recently showed that the nasal mucus proteome between~     allergic rhinitis patients and healthy controls is significantly altered.~      The aim of the present project is to show changes in nasal mucus proteome between allergic~     rhinitis patients and healthy controls over the pollen and non pollen season and to further~     determine whether and if so how the proteome changes under immunotherapy. Patients and~     healthy controls will be enrolled at two time points namely during the pollen season and out~     of the pollen season. Statistical differences will be determined within the groups and~     between the groups as well as impact of immunotherapy on patients undergoing therapy.~      Mucus will be collected with a special suction device equipped with a mucus trap. Then,~     proteomic analysis will be performed by LC MS/MS mass spectrometry. Database search will~     identify distinct proteins and their function, origin etc. will be annotated. Protein groups~     will be analyzed through pathway enrichment and cluster analysis. Furthermore, mechanisms of~     immunotherapy in responders and success or failure of therapy could be determined. These~     could lead to the identification of potential biomarkers.~   "
107570|NCT02159391|"~     The purpose of this study is to determine whether the Brief Motivational Interview will~     produce a significantly reduction in risk behavior than usual treatment 3 months after~     discharge from hospital in people who have survived a traumatism.~   "
107571|NCT02159378|"~     The prevalence of gestational diabetes is estimated at between 2 and 6%, but can be much~     higher in specific populations.~      The specific treatment of gestational diabetes (diet, control weight gain, self monitoring~     glucose , insulin therapy) reduces complications severe perinatal, fetal macrosomia, and~     preeclampsia compared with abstention therapy, without additional risk of caesarean section.~      Several early studies have shown that the determination of fructosamine is a very bad way of~     diagnosis for Gestational Diabetes. However, few studies have investigated the relationship~     between the determination of serum fructosamine and put under insulin in case of Gestational~     Diabetes.~      The purpose of this study is to determine if serum fructosamines rate can be a predictive~     marker of the starting insulin at the patients suffering from Gestational Diabetes~   "
107572|NCT02159365|"~     To explore whether Elotuzumab dose administration over approximately 60 minutes is feasible~     and safe.~   "
107573|NCT02159352|"~     The purpose of this study is to determine whether multiple doses of darunavir/ritonavir or~     lopinavir/ritonavir affect the pharmacokinetics of daclatasvir in healthy participants.~   "
107574|NCT02159339|"~     Gastric carcinoma (GC) is the second leading cause of cancer death throughout the world. In~     previous multi-center study, we have found that the prevalence of GDNF family receptor alpha~     1(GFRA1), serum response factor (SRF), and ZNF382 methylation alterations were inversely and~     coordinately associated with GC metastasis and the patients' overall survival throughout~     discovery and testing cohorts in China, Japan and Korea. The present cohort study is to~     investigate whether methylation of those genes can predict the metastasis and prognosis of~     GC.~   "
107575|NCT02159326|"~     Physicians might be concerned that Adempas may have a metabolic interaction with oral~     contraceptives (OC) that could decrease the contraceptive efficacy of the OC. The information~     regarding lack of potential pharmacokinetic interaction has been communicated; there is a~     need for more re-assurance and further data that there is no interaction between Adempas and~     OCs. A drug-drug interaction study of riociguat with an OC such as Microgynon in the least~     vulnerable population for these purposes, i.e. healthy postmenopausal women, is considered~     adequate to inform about safe use of Adempas with OCs.~   "
107576|NCT02159313|"~     To investigate relative bioavailability of crushed tablets suspended in apple sauce or water~   "
107577|NCT02159300|"~     The long-term purpose of the investigator's research is to understand the pathophysiological~     basis of chronic pain. This will help provide a framework for the development of effective~     treatments. The purpose of this specific study is to find if there are abnormal brain rhythms~     in patients with fibromyalgia syndrome (FM) who are in pain since this will indicate~     particular types of treatments.~      FM is a disorder of the muscles and/or joints, and patients experience sever fatigue. FM~     occurs more often in women than in men (3.4% of women, 0.5% of men). The diseases can appear~     at any age, but in most of the cases it occurs in women of childbearing age. FM is considered~     a chronic pain condition since the pain is persistent. Pain and tenderness can be widespread~     throughout the body. FM patients are more sensitive to sound and pressure stimulation than~     healthy controls, indicating that there may be changes in the brain. Also, pain is made worse~     under conditions of stress.~      Treatments for FM pain include life style changes such as exercise, dietary changes,~     cognitive-behavioral therapy, medications and even surgery, but there is no accepted best~     treatment. This is partly because the underlying cause of the pain is not well understood.~     The design of this study is to record brain activity to find if there are abnormal brain~     rhythms in people with FM that are not present in healthy adults of the same age.~      Specifically, the investigators will test the hypothesis that constant low frequency~     oscillations will be present in patients with chronic pain due to FM. This has been found in~     people with other types of pain and is called Thalamocortical Dysrhythmia (TCD). The study~     has two parts. In the first part, a complete medical history will be obtained, including a~     description of the person's pain. In the second part the investigators will use~     magnetoencephalography (MEG) to non-invasively record brain activity. The MEG data will be~     analyzed in terms the presence of normal alpha rhythm and abnormal low and high frequency~     oscillations. Each person will have an MRI so the investigators can localize the rhythms~     recorded by the MEG in the person's brain using their MRI. The people who record and analyze~     the MEG recordings will not know if the person is a healthy control or a FM patient. The two~     parts will be joined to test the hypothesis and find if there is a correlation between the~     people with abnormal low frequency brain rhythms and the presence or degree of pain.~   "
107665|NCT02158156|"~     The investigators want to investigate if patients with Oculopharyngeal Muscular Dystrophy can~     improve fitness by home-training on a cycle ergometer 30 minute, 3 times a week for 10 weeks.~      Participants will be evaluated on maximal oxygen consumption and maximal workload measured by~     an incremental test at baseline and at the end of the exercise period.~   "
107578|NCT02159287|"~     Patients with Atrial fibrillation (AF) make a unique group of ischemic stroke, mostly caused~     by emboli from the left atrial appendage. Oral anticoagulation (Warfarin) is recommended for~     prevention of recurrent embolic stroke but it takes several days to reach a therapeutic~     international normalized ratio (INR : 2.5) so bridging therapy with a short acting~     intravenous anticoagulant is recommended until therapeutic INR level is reached. A common~     strategy is to use intravenous unfractionated heparin (UFH) until a standard activated~     partial thromboplastin time (aPTT) is reached and then initiating warfarin. Another strategy~     is to use subcutaneous (SQ) injection of a low-molecular-weight heparin (LMWH) eg.~     Enoxaparin.~      The investigators will compare LMWH and UFH, focusing on risk of new stroke and mortality~     rate.~      METHOD: This study is randomized controlled trial that will be performed in 80 patients ages~     between 18 and 75 with confirmed acute ischemic stroke purely due to AF who will be~     hospitalized in Shiraz Medical University affiliated teaching hospitals. Patients will be~     randomly assigned in two groups. A brain CT will be done to confirm the absence of~     intracranial hemorrhage and to assess the size of cerebral ischemia.~      First group will receive 1 mg of enoxaparin (Clexane, Sanofi, Paris) per kilogram of body~     weight SQ every 12 hour with warfarin 5mg orally everyday and both drugs will be continued~     until the target INR level (2.5) is reached then clexane will be discontinued.~      The second group will receive continuous UFH infusion 1000 unit per hour and then the dose~     will be adjusted to maintain a therapeutic aPTT (two times to baseline) level then warfarin~     will be started (5 mg everyday).~      The investigators will follow patients in both groups until target INR will be achieved (2.5)~     and after that clexane and UFH will be discontinued. Adverse events will be assessed in both~     groups for three months.~      Data will be analyzed with Statistical Package for the Social Sciences (SPSS) version 15 and~     Chi-square statistics.~      Main outcome of our study will be evaluation of new stroke, mortality, central nervous system~     (CNS) hemorrhage, major bleeding, drop out and other unwanted side effects in first week and~     three months after stroke.~   "
107579|NCT02159274|"~     Breast cancer affects a large proportion of Danish women and late morbidity following breast~     cancer treatment including pain, reduced motility and force of the arm and shoulder,~     disturbed sensitivity, and lymph edema affects many patients. The risk for such late~     complications have previously been carefully described by us and others in patients operated~     by traditional methods, but the follow-up in most of these studies have been rather short ,~     and long time follow-up results are not available. The impact of the new oncoplastic~     techniques that allows more women to have breast conserving surgery is not known yet. These~     operations are more extensive and therefore might be accompanied by more complications. The~     purpose of this study is to give answer to that question.The study includes three parts.~     First a questionnaire to patients who have breast conserving surgery performed in one of the~     three breast units in Central Region Denmark. It contains questions regarding arm morbidity,~     quality of life, comorbidity, and body image. The questionnaire should be filled in~     preoperatively and 18 months after surgery. The second part consists of an objective~     evaluation of shoulder and arm function and cosmesis before and after breast conserving~     surgery with and without oncoplastic techniques. This should be performed at baseline before~     surgery and 18 months later. The third part is a long time follow-up of patients after breast~     conserving surgery without oncoplastic techniques. This group of patients is recruited from~     three breast units in Central Region Denmark. It contains questions regarding arm morbidity,~     quality of life, comorbidity, and body image. The questionnaire should be filled in~     preoperatively and 18 months after surgery. The second part consists of an objective~     evaluation of shoulder and arm function and cosmesis before and after breast conserving~     surgery with and without oncoplastic techniques. This should be performed at baseline before~     surgery and 18 months later. The third part is a long time follow-up of patients after breast~     conserving surgery without oncoplastic techniques. This group of patients is recruited from~     the cohort in a previous study with 18 months follow-up following breast conserving surgery~     without oncoplastic technique.~   "
107580|NCT02159261|"~     Local prospective multicenter non-comparative non-interventional observational study. It's~     planed to assess satisfaction of patients and physicians with results of Yaz Plus treatment~     for 13 cycles in real practice.~   "
107581|NCT02159248|"~     The purposes of this study are to:~        -  Evaluate the safety and toxicity of tolfenamic acid when used with gemcitabine and~          radiation therapy in patients with locally advanced or metastatic pancreatic cancer.~        -  Determine the maximum-tolerated dose (MTD) of tolfenamic acid when used with gemcitabine~          and radiation in pancreatic cancer.~        -  Characterize the pharmacokinetic profile of tolfenamic acid when used with gemcitabine~          and radiation.~        -  Assess the anti-tumor response to tolfenamic acid when used with gemcitabine and~          radiation in patients with advanced pancreatic malignancies.~   "
107582|NCT02159235|"~     The present study aims is to investigate:~        1. whether patients suffering from acute resp. chronic ischemic heart disease show higher~          levels for cadmium (Cd), lead (Pb) and mercury (Hg) than local and international~          reference levels suggest;~        2. the correlation between severity of coronary artery disease and angiogenic and~          angiostatic factors (endostatin-ES, angiostatin-AS, VEGF-vascular endothelial growth~          factor, osteopontin-OPN) The patient population consists of about 270 female and male~          patients suffering either acute or chronic ischemic heart disease (AIHD:ICD-10 I21;~          CIHD: ICD-10 I25).~        3. whether patients suffering CAD and valve calcification (mitral annulus, aortic valve)~          show higher levels of endostatin, angiostatin, osteopontin and VEGF compared to patients~          with CAD but without valve (annulus) calcification The measurement of cadmium (urine),~          lead, mercury, zinc, endostatin, angiostatin, VEGF (serum) and osteopontin (plasma) in~          patients with angiographically verified coronary artery disease are in the fore.~          Furthermore, basic laboratory diagnostics as well as data from coronary angiography and~          echocardiography will be collected. Additionally, the investigators will inquire heavy~          metal exposition during life by an interview.~      Recruitment will be done during the in-patient stay at the General Hospital of Vienna,~     Medical University of Vienna.~   "
107583|NCT02159222|"~     The purpose of this study is to determine whether an additional physical therapy program can~     improve the mobility and functional outcomes of patients diagnosed with severe sepsis (an~     illness in which the body has a severe response to bacteria or other germs and develops~     worsened function of a major organ such as the kidneys, heart, or lungs).~   "
107584|NCT02159209|"~     Some medications are known to cause kidney damage because the person is allergic to the~     medication while others cause direct damage to the kidney because they are toxic at certain~     concentrations. Risk factors for developing kidney damage have been identified for some~     medications but not for all. Patients who are exposed to these important medications and~     develop problems with their kidneys may have some genetic risk. The purpose of this study is~     to determine the genetic risk factors for drug induced kidney injury. A better understanding~     of the role of genetics for the development of kidney injury from medications will allow us~     to better select medications, improve effectiveness of treatment and minimize harm.~   "
107585|NCT02159196|"~     The purpose of this multi-center randomized controlled non-inferiority trial is to determine~     the effect of a strategy using routine nebulisation of mucolytics and bronchodilators (four~     times daily) as compared to a strategy using nebulisation of mucolytics or bronchodilators~     only on clinical indication (i.e. occurrence of persistent thick and tenacious sputum or~     bronchospasm) in mechanically ventilated intensive care patients. The investigators will~     examine the effects in terms of ventilator-free days, defined as the number of days alive and~     free of ventilation at day 28 after start of ventilation.~      We hypothesize that a strategy that uses nebulisation of mucolytics or bronchodilators only~     on clinical indication not to be inferior to a strategy using preventive nebulisation of~     mucolytics or bronchodilators with regard to the number of ventilator free days in ICU~     patients at day 28.~   "
107586|NCT02159183|"~     This study will investigate the effect on the soft tissue that is in contact with a dental~     implant with a modified surface of the neck (the part of the implant that is above the bone~     and in contact with the soft gum tissue).~   "
107666|NCT02158143|"~     evaluated the effect and safety of a single high dose of cholecalciferol in Chinese young~     people.~   "
107587|NCT02159170|"~     Intraepidermal injection of nerve growth factor results in a non-inflammatory hyperalgesia~     for thermal and mechanical stimuli. This hyperalgesia is similar to the pathological ailments~     of patients with neuropathic pain. The mechanisms of the cognitive modulation of pain and~     hyperalgesia are not yet understood in this group of patients. The investigators plan to use~     NGF injection as a model of non-inflammatory neuropathic pain in healthy subjects to~     investigate the underlying neuronal mechanisms of this hyperalgesia using functional magnetic~     resonance imaging and resting state network analysis.~   "
107588|NCT02159157|"~     This study is designed to randomly assign breast cancer patients requiring and agreeing to~     chemotherapy into two groups. One group will be receive an exercise prescription aimed at~     increasing physical activity by a minimum of 10 MET (metabolic equivalent task) hours per~     week. The other group will not receive a exercise prescription but their activity will be~     recorded. The hypothesis is that participants that are most active will exhibit improved~     chemotherapy completion rates, improved fitness, less fatigue and lower levels of markers for~     inflammation in their blood.~   "
107589|NCT02159144|"~     Adipose tissues, which include white adipose tissue (WAT) and brown adipose tissue (BAT),~     play an essential role in regulating whole-body energy homeostasis. Recent studies also~     reveal the presence of a subset of cells in WAT that could be induced by environmental or~     hormonal factors to become ''brown-like'' cells, and this ''beigeing'' process has been~     suggested to have strong antiobesity and antidiabetic benefits. More recently, same studies~     showed that cold stress stimulate the browning of subcutaneous white adipose. However, to the~     investigators knowledge, there are no direct data that clearly show that cold stress can~     promote the browning of subcutaneous white adipose.~   "
107590|NCT02159131|"~     This open-label, fixed-sequence crossover study aims to evaluate the effect of GSK1265744~     (744) oral administration on the pharmacokinetics (PK) and pharmacodynamics (PD) of a~     commonly used oral contraceptive (OC) product (combination of ethinyl estradiol and~     levonorgestrel), in 20 healthy female subjects. Each subject will participate in a Run-in~     Period (if needed), followed by a single-sequence Treatment Period. Subjects will receive~     oral contraceptive containing Levonorgestrel and Ethinyl Estradiol on Days 1 to 21 and be OC~     free on Days 22 to 28, during which withdrawal menses should occur. Subjects will receive OC~     alone on Days 1 to 10. Levonorgestrel (LNG) and ethinyl estradiol (EE) PK will be determined~     on Day 10. Subjects will then co-administer 744 and OC on Days 11 to 21. Levonorgestrel and~     ethinyl estradiol PK will be determined again on Day 21 to assess if co-administration with~     744 results in a significant change in OC exposure compared to OC alone. Subjects will return~     to the study center for final follow-up evaluations 7 to 14 days after the last dose of study~     medication (Days 28 to 35).~   "
107591|NCT02159118|"~     The purpose of this study is to compare use of a powered bone marrow aspiration and biopsy~     device (OnControl) to use of a standard manual bone marrow aspiration and biopsy device to~     obtain bone marrow biopsy specimens in children. The hypothesis is that use of the powered~     device will improve the quantity and quality of bone marrow biopsy specimens when compared to~     the manual device.~   "
107592|NCT02159105|"~     This study is designed to see if abdominal ultrasound after planned cesarean delivery can~     identify women with ongoing intra-abdominal bleeding.~   "
107593|NCT02159092|"~     Tobacco use kills more than 500,000 people in the United States each year. Although the use~     of cigarettes has declined, the use of other tobacco products has remained steady. Waterpipe~     smoking is a common form of tobacco smoking after cigarettes in the U.S. In fact, in 2007 the~     American Lung Association issued a policy alert to warn consumers about this first new~     tobacco trend of the 21st century (American Lung Association, 2007). Few studies have been~     conducted on waterpipe smoking to investigate its harmful effects. Furthermore, no known~     studies have evaluated treatments for smoking cessation in waterpipe smokers. This study aims~     to test the role of contingency management (CM) in promoting abstinence from waterpipe~     smoking for 5 weeks verified by salivary cotinine and to characterize self-reported nicotine~     withdrawal symptoms. Based on the alarming growth rate over a short period of time in~     waterpipe tobacco smoking, there is a critical need for clinical research to investigate~     treatment modalities targeting smoking cessation for waterpipe smokers. Given the evidence~     for the role of CM in promoting abstinence from many types of drug use, investigation of the~     utility of CM for waterpipe smoking cessation is important and timely. Although Nicotine~     Replacement Therapy is the mainstay treatment for treating nicotine dependence delivered~     through cigarettes, the intermittent use patterns that characterize waterpipe smoking suggest~     that CM may be more effective in promoting waterpipe smoking cessation. The evidence based~     knowledge generated in this study may assist in the translation of the treatment program into~     public health practice.~   "
107594|NCT02159079|"~     Sepsis is a common inflammatory response to infection characterized by hypovolemia and~     vasodilation for which early administration of intravenous fluids has been suggested to~     improve outcomes. The ideal fluid balance following initial resuscitation is unclear. Septic~     patients treated in the intensive care unit commonly receive significant volumes of~     intravenous fluids with resultant positive fluid balance for up to a week after their initial~     resuscitation. Observational studies have associated fluid receipt and positive fluid balance~     in patients with severe sepsis and septic shock with increased mortality but are inherently~     limited by indication bias. In order to determine the optimal approach to fluid management~     following resuscitation in patients with severe sepsis and septic shock, a randomized~     controlled trial is needed. The primary hypothesis of this study is that, compared to usual~     care, a conservative approach to fluid management after resuscitation in patients with sepsis~     and cardiopulmonary dysfunction will increase intensive care unit free days.~   "
107595|NCT02159066|"~     The primary purpose of this study is to assess the anti-tumor activity of LGX818/MEK162 in~     combination with targeted agents after progression on LGX818/MEK162 combination therapy, as~     well as the safety and tolerability of the novel triple combinations.~   "
107596|NCT02159053|"~     The purpose of this study is to provide 16-week efficacy, safety and tolerability data versus~     placebo to support the use of secukinumab 150 mg by subcutaneous (s.c.) self-administration~     with or without a loading regimen and maintenance dosing using pre-filled syringe (PFS) and~     to assess efficacy, safety and tolerability up to 2 years in subjects with active AS despite~     current or previous NSAID, non-biologic DMARD, or biologic anti-TNFα therapy.~   "
107598|NCT02159027|"~     Maraviroc is an antiretroviral medication that may help in improving mental function in HIV~     infected patients with mental problems by decreasing inflammatory tendencies. We will test~     this in a clinical trial of 42 HIV infected individuals with some mild to moderate mental~     problems who are already on HIV medications and doing well. We will add Maraviroc or a sugar~     pill to their HIV medications and see if mental function improves over 48 weeks. This study~     will be conducted at 2 sites in Hawaii and Puerto Rico.~   "
107599|NCT02159014|"~     Regular physical activity improves physical and mental health and reduces the risk of heart~     disease, stroke, cancer, diabetes, obesity and premature death from any cause. Unfortunately~     the majority of adults are not active enough to reap these benefits. People who are inactive~     and at high risk of stroke, heart disease, diabetes and dementia, and who may benefit from~     increased activity can be identified in primary care by combining standard risk tools. These~     high risk patients can be offered physical activity programmes that are designed to increase~     longterm adherence. Aerobic dance is an activity that combines physical, social and cognitive~     stimulation and allows easily adjusted intensity levels to meet individual needs. Engagement~     in an activity program also provides opportunities to offer advice on healthy nutrition and~     associated meal preparation skills. Information technology can be used to increase activity~     participation. Video materials can be produced to guide activity participation at home,~     thereby increasing overall activity participation. The investigators propose a feasibility~     study of a multimodal dance-based physical activity and nutrition intervention aimed at~     patients at high risk of stroke, heart disease, diabetes and dementia, in primary care~     settings.~   "
107600|NCT02159001|"~     Electroconvulsive therapy (ECT) is one of the oldest neuromodulation treatments still used in~     psychiatry. Only case reports and open label non-randomized studies have been published of~     ECT in clozapine-resistant schizophrenia patients. The purpose of this trial is to study the~     efficacy and cognitive effects of add-on ECT treatment (10-course) in schizophrenia patients~     taking clozapine.~   "
107601|NCT02158988|"~     Patients with histological proven gastric cancer (including cancer of the esophagogastric~     junction (AEG)) and synchronous peritoneal carcinomatosis, who fulfill the inclusion and~     exclusion criteria, can be recruited in this study. There are two treatment groups (A and B).~     The chemotherapy applied intravenously is the same in both groups and is approved for the~     treatment of gastric cancer. Patients with negative or unknown HER-2 status will be~     administered Epirubicin, Oxaliplatin and Capecitabine (EOX). Patients with positive HER-2~     status will be treated with Cisplatin, Capecitabine and Trastuzumab (CCT).~      The chemotherapy is followed by surgical cytoreduction in both groups. Patients randomized~     into group B will be treated with an intraperitoneal (in the abdominal cavity) chemoperfusion~     with Mitomycin C and Cisplatin .~      Patients in both groups receive 3 cycles of postoperative chemotherapy within 4-12 weeks~     after the surgical procedure and are followed up for 30 months.~      If progress of the tumor is detected the patient will no longer be treated according to the~     study therapy. Patients of group B may get a HIPEC intervention without surgical~     cytoreduction if contraindication to the drugs applied can be excluded.~   "
107602|NCT02158975|"~     Historically cutaneous and peripheral T-cell lymphomas have response rates of approximately~     30% to standard chemotherapy regimens. We alternatively hypothesize that MLN9708 will be~     active in this disease and will improve best objective response.~      We will also determine the extent to which MLN9708 inhibits GATA-3 (Trans-acting~     T-cell-specific transcription factor) expression, which is associated with poor prognosis,~     and whether GATA-3 expression represents a novel predictive biomarker for MLN9708~     sensitivity.~   "
107603|NCT02158962|"~     The purpose of this study is to combine a culturally tailored and integrated Risk Reduction~     Intervention in the US Virgin Islands (USVI) in a clinical trial randomly assigning abused~     women to a 1) Healthy Relationships experimental group of three sessions of risk reduction~     interventions or 2) a Healthy Living comparison control group of three session of health~     promotion activities to determine if the combined, intervention is safe and effective in a~     test the following hypotheses:~        1. Women in the integrated risk reduction intervention will score significantly lower on~          outcome measures of intimate partner abuse (IPA) and STD/HIV risk behaviors end of~          Session III and at 3 and 6 months than women in the control group~        2. Women in the integrated risk reduction Intervention will score significantly higher on~          IPA safety behaviors and STI/HIV prevention behaviors at end of Session III and at 3 and~          6 months than women in the control group.~      Several exploratory and major controlled studies on the mainland US have shown intimate~     partner violence (IPV) and intimate partner abuse (IPA) to be risk factors for a variety of~     physical, reproductive and mental health problems, including sexually transmitted infections~     and HIV/AIDS, many of which are areas of known health disparity for African American and~     Latina women. A recently completed study of African Caribbean and African American women in~     the US Virgin Islands revealed that nearly one third of women reported lifetime partner abuse~     and increased risk for sexually transmitted infections including HIV/AIDS. Abused women in~     the USVI had significantly more risk factors for HIV/AIDS than did women who were not abused.~      The proposed intervention combines an empowerment model designed to help abused women make~     choices that protect the physical and emotional health of the woman and her family with a~     sexual safety model designed to help her make choices to reduce her risk of acquiring an STI~     or contracting HIV/AIDS. The integrated model adapts two interventions that have been tested~     with African American women on the US mainland and found to be effective as separate~     interventions for IPV and IPA and reducing the risk of STI/HIV. The adapted interventions~     will be used with abused African Caribbean women based on an a priori assessment of the~     cultural attitudes, beliefs and resources available to women living in an island environment~     with limited resources.~   "
107604|NCT02158949|"~     In this study, the investigators will be developing and testing a mobile phone text message~     intervention to reduce alcohol use for people at risk of alcohol dependence. The~     investigators hypothesize that this intervention will be acceptable to participants, and that~     they will stay in the intervention until it's one week completion.~   "
107605|NCT02158936|"~     Eltrombopag olamine (SB-497115-GR) is an orally bioavailable, small molecule thrombopoietin~     receptor agonist that may be beneficial in medical disorders associated with~     thrombocytopenia. Eltrombopag has been shown to increase platelet counts in patients with~     thrombocytopenia from various etiologies (Idiopathic thrombocytopenic purpura [ITP], liver~     disease, aplastic anemia and chemotherapy induced thrombocytopenia). Approximately 350~     subjects will be randomized in a 1:1 ratio (175 into the eltrombopag arm and 175 into the~     placebo arm). Approximately 55 subjects will be enrolled into the azacitidine. Subjects with~     intermediate-1, intermediate-2 or high risk MDS by IPSS, and baseline platelet count of <75~     Giga (10^9) per liter (Gi/L) will only be enrolled. This is a randomized, double-blind,~     parallel group, placebo-controlled study designed to explore the platelet supportive care~     effects of eltrombopag versus placebo in combination with the standard of care~     hypomethylating agent, azacitidine. The primary objective of this study is to determine the~     effect of eltrombopag versus placebo on the proportion of subjects who are platelet~     transfusion free during the first 4 cycles of azacitidine therapy. Key secondary endpoints~     include overall survival, disease response, and disease progression.~   "
123380|NCT01952535|"~     The objectives of this study is to determine the safety profiles, tolerability,~     pharmacokinetics and pharmacodynamics of HMS5552 following single ascending doses in healthy~     adult subjects.~   "
107606|NCT02158923|"~     The purpose of this study is to determine whether individualized ventilatory management~     combining the use of low tidal volumes, alveolar recruitment maneuvers, individually titrated~     positive end-expiratory pressure and postoperative individualized ventilatory support will~     decrease postoperative complications, unplanned ICU readmissions, ICU and hospital length of~     stay and mortality compared to a standardized Lung Protective Ventilation (LPV) for all~     patients at risk.~   "
107607|NCT02158910|"~     The purpose of the study is for investigation and collection of Aricept safety information~     with a dose increase on Alzheimer's disease patients.~   "
107608|NCT02158897|"~     Evidence from bio-gerontology research from our laboratory and others have showed that~     short-term fasting/starvation (STS) can improve the efficacy of chemotherapy by protecting~     normal cells and tissues and potentially sensitizing malignant cells to chemo drugs.~     Furthermore, STS improves risk factors associated with aging and age-related disease in~     rodent models. Prolonged fasting, however, is difficult to implement and may not be feasible~     or safe in humans. We have developed a fasting-mimicking diet (FMD) that was well accepted in~     a pilot human trial. The objective of the study is to ascertain the impact of the~     fasting-mimicking diet given to adult subjects for 5 days a month for 3 consecutive months.~     The investigators hypothesize that the specially designed dietary regimen can reduce the risk~     factors for metabolic syndrome and biomarkers associated with aging and age-related diseases.~   "
107609|NCT02158884|"~     The goal of the PRIORITI-MTF study is to help determine whether a new type of custom designed~     brace, called the IDEO ™ along with a physical therapy program, called Return to Run,~     improves physical function. This brace was developed for wounded warriors who wanted to~     return to an active lifestyle.~      The primary objective of this study is to examine the benefits (and cost-benefits) of an~     integrated orthotic and rehabilitation program that incorporates the Intrepid Dynamic~     Exoskeletal Orthosis (IDEO) and the Return to Run (RTR) physical therapy regimen, but~     designed for scalability in the broader military environment (i.e. beyond San Antonio~     Military Medical Center where the program was developed)~   "
107610|NCT02158871|"~     The purpose of this study is to compare the impact of a new workplace-based mental health~     peer education program with standardized mental health literacy training on early~     intervention and support for healthcare employees with mental health issues. Participants are~     healthcare workers who volunteer to participate in one of the two twelve-hour group education~     programs. It is hypothesized that the customized Beyond Silence peer education program led~     by trained staff members with personal experience of mental ill-health will be more effective~     in reducing the stigma associated with help-seeking and help-outreach regarding mental~     ill-health in the workplace. The comparison group is a standardized mental health literacy~     training program that has been widely implemented in both Canada and around the world. Change~     in help-seeking/help-outreach behavior, mental health knowledge and beliefs of participants~     will be assessed at three-month intervals; before, after and three months following the~     educational intervention.~   "
107611|NCT02158858|"~     Phase 1 Part (Complete): Open-label, sequential dose escalation study of CPI-0610 in patients~     with previously treated Acute Leukemia, Myelodysplastic Syndrome,~     Myelodysplastic/Myeloproliferative Neoplasms, and Myelofibrosis.~      Phase 2 Part: Open-label study of CPI-0610 with and without Ruxolitinib in patients with~     Myelofibrosis.~      CPI-0610 is a small molecule inhibitor of bromodomain and extra-terminal (BET) proteins.~   "
107612|NCT02158845|"~     The hemostatic and inflammatory systems may activate each other. Endometriosis is a chronic~     inflammatory disease affecting 10% of women. The objective of this study is to compare the~     hemostatic effects of two treatments widely prescribed to women with endometriosis: the~     levonorgestrel intrauterine system (LNG-IUS) and the gonadotropin-releasing hormone analog~     (GnRHa) leuprolide acetate.~      Hypothesis:~      H0: There is no alteration in hemostatic system with the use of GnRHa or LNG-IUS H1: There is~     alteration in hemostatic system with the use of GnRHa or LNG-IUS~   "
107613|NCT02158832|"~     This study is being conducted to determine if electro-acupuncture can reduce swelling of the~     arm due to breast cancer treatment (commonly referred to as 'lymphedema'). Research conducted~     on animals suggests that such treatment might be used to improve circulation leading to~     reductions in swelling. Previous research in humans with lymphedema suggests that treatment~     may be safe to use, although results regarding its efficacy in the reduction of swelling have~     not yet been established.~      This research will use sophisticated, non-invasive assessment methods to determine if a~     single session of electro-acupuncture treatment can be effective for reducing lymphedema.~     Results may be used to further develop our understanding of how electro-acupuncture can be~     used in the management of this condition. Electro-acupuncture may provide a promising~     complement or alternative to conventional lymphedema treatments such as compression~     bandaging, massage therapy or surgery.~   "
107614|NCT02158819|"~     The purpose and primary objective of this study is to compare health economic outcomes~     between the use of a patient-matched cutting guide (Visionaire) versus the use of standard~     instrumentation in Total Knee Arthroplasty(TKA). Data will be collected pre-operatively,~     intra-operatively and post operatively up until and including the six week post-operative~     assessment. The secondary objectives of the study are to compare safety and early readmission~     rates between the two techniques. The study hypothesis is that there is no difference in the~     cost of the episode of care from hospital admission to discharge, including pre-operative~     radiology costs and cost of resources, with the Visonaire patient-matched cutting guide~     compared to standard instrumentation.~   "
107615|NCT02158806|"~     Venous leg ulcers (VLU) are the most common leg ulcer, can be painful, and limit work,~     lifestyles and activity, especially in older patients. There are few effective treatments -~     compression therapy (tight bandaging or stockings) helps healing, but about half the people~     with a VLU remain unhealed even after 12 weeks of treatment. Research suggests taking aspirin~     as well as using compression may speed up healing for VLU, but the current evidence is not~     enough to change clinical practice. We will conduct a randomised controlled trial to test~     whether using low dose aspirin (150 mg daily or placebo) really does speed up healing.~   "
107616|NCT02158793|"~     The purpose of this study is to perform face transplants on people who have suffered severe~     facial trauma with tissue and functional loss; and evaluate the acceptance and function of~     the transplanted tissue. The aim of the transplant is to provide patient a more normal~     appearance . Additionally we aim to restore functioning, movement, and sensation of their~     face including that of the lips, mouth, and eyes.~   "
107617|NCT02158780|"~     Undescended Testis is the most common congenital abnormality of the genitalia in boys and it~     is commonly managed by surgical intervention. Evidence in the medical literature to support~     the superiority of either scrotal or inguinal (standard) orchidopexy is lacking. To determine~     which technique is superior, this study focuses on the degree of post-operative pain after~     surgery. Therefore, the objective of this randomized control trial is to determine if scrotal~     orchidopexy reduces postoperative pain in children diagnosed with undescended testis when~     compared to standard inguinal orchidopexy.~   "
107618|NCT02158767|"~     This clinical trial studies the use of a second infusion of donor hematopoietic cells that~     have had removal of T cells for the treatment of engraftment failure after a first~     hematopoietic stem cell transplant.~      Hematopoietic cell transplants from donors can be complicated by complete or incomplete~     failure of recovery of blood counts. This results in frequent needs for transfusions and~     other methods to maintain blood counts at acceptable levels. One way of improving the blood~     counts in the recipient is to give a booster dose of cells from the donor, but this is~     associated with increased risk of an immune reaction from the donor cells against the~     recipient cells. To decrease this risk, it is possible to decrease the amount of T cells,~     responsible for this type of immune reaction. These cells are removed by a special handling~     of the graft, which allows to remove the cells directly or indirectly (by selecting other~     cells to stay in the graft).~   "
107619|NCT02158754|"~     This retrospective study will investigate clinician behavior in diagnosing patients with~     possible obstructive coronary artery disease who received a Corus CAD (Age/Sex/Gene~     Expression score - ASGES) result compared to patients who did not have the test performed~     (matched control patients).~   "
107620|NCT02158741|"~     The overall purpose of this research is to examine and compare the effectiveness and costs of~     a community-based intervention to support self-management with usual primary care for older~     adults with Type 2 Diabetes Mellitus and multiple chronic conditions and their family~     caregivers. Once the study is complete, the investigators will be able to determine if there~     is any measurable difference in self-care management between usual care plus the intervention~     versus usual care alone.~   "
107621|NCT02158728|"~     To collect supraventricular tachycardia (SVT) data for developing and testing sensing and~     detection algorithms for a subcutaneous implantable cardioverter defibrillator (ICD).~   "
107622|NCT02158715|"~     For Cardiopulmonary Resuscitation(CPR) education, depth of chest compression is most~     important teaching point. However, the tool to feedback depth of chest compression like~     Resusci Annie Skill Reporter(Laedal Medical AS, Norway) is very helpful but too expensive to~     be used widely. In these days, smartphone free application can measure depth of chest~     compression in real-time. This study assess the validity of depth of chest compression by~     smartphone application, PocketCPR, as three sites of smartphone on arm or hand.~      1. grap it in hand, 2. fix it on upper arm with arm band, 3. grap it in hand with arm band~      To analyze the difference between Skill Reporter manikin and PocketCPR application, the~     investigators will use Intraclass Correlation Coefficient(ICC) as statistical method.~   "
107623|NCT02158702|"~     Asian patients with relapsed myeloma after prior treatment with bortezomib and lenalidomide~     will treatment on pomalidomde and dexamethasone.~      Baseline, follow-up, survival and toxicity information will be collected.~   "
107624|NCT02158689|"~     The accurate identification and efficient management of poor responders remains one of the~     most enigmatic challenges in assisted reproductive technology (ART). The investigators study~     will compare the letrozole/antagonist protocol to the hMG/antagonist protocol in women who~     poor responders.~   "
107625|NCT02158676|"~     The study will recruit patients submitted to bariatric surgery. Individuals will be~     supplemented with 6g/day of prebiotic or synbiotic or placebo (maltodextrin) for 15 days.~     Immunological, metabolic and anthropometric parameters will be assessed before and after the~     supplementation. Our hypothesis is that prebiotic or synbiotic supplementation modulate~     plasma concentrations of immunological and metabolic parameters and anthropometric measures~     of subjects undergoing gastric bypass Roux-Y.~   "
107626|NCT02158663|"~     Objectives: The primary objective is to test whether right prefrontal cortex low frequency 1~     Hz rTMS versus right prefrontal high frequency 10 Hz rTMS provides a significantly greater~     improvement in function as measured by IPF score and PTSD symptoms as measured with CAPS~     score. The secondary objectives include: one, testing which treatment provides a~     significantly greater improvement in depressive symptoms as measured by change in QIDS score;~     two, testing whether depression impacts effectiveness of 1 Hz versus 10 Hz rTMS for PTSD~     symptoms; and three, testing which treatment is better tolerated as measured by participant~     drop out and side effect profiles.~      Research Design: Randomized single-blind (raters) prospective clinical trial testing the~     effectiveness 1 Hz rTMS versus 10 Hz rTMS in veterans with PTSD.~      Methodology: Veterans 18 to 50 years of age suffering from PTSD with and without depressive~     symptoms will be recruited from the community as well as from the mental health clinics at~     the James A. Haley Veterans Administration Hospital. Plan to enroll 50 in order to have an~     evaluable sample of approximately 20 in each group. Participants will be consented and~     undergo screening for safety and appropriateness to be in the trial. Those deemed eligible~     will be evaluated with clinical measures of function, PTSD, depression, pain, and~     neurobehavioral symptoms. Participants will be randomized in equal proportion (stratified by~     significant depression defined as MADRS greater than 19) to one of two active treatments:~     right prefrontal 1 Hz rTMS versus right prefrontal 10 Hz rTMS. Participants will undergo~     assessment for safety prior to each treatment. The treatments will be performed 5 days a week~     for 6 weeks with a 3-week taper consisting of 3 days per week, 2 days per week, and 1 day per~     week. Clinical evaluations will be performed at baseline, after every five treatments, at the~     end of the treatment, and at 1 and 3 months post treatment. CAPS and IPF scores will be used~     to determine if there is a significant difference between 1 Hz and 10 Hz right prefrontal~     rTMS for PTSD symptoms and function respectively. The QIDS scores will be used to test for a~     significant difference in change in depressive symptoms for both the participants with~     significant depressive symptoms and the entire group. The number of dropouts (related~     specifically to side effects and all cause) will be used along with side effect profiles to~     test for differences in tolerability of the two treatments.~   "
107627|NCT02158650|"~     The purpose of this study is to determine if presenting treatment options to basal cell~     carcinoma patients in video format will improve efficiency and allow patients to receive~     consistent, comprehensive, visually-depicted treatment option information to improve patient~     quality of care. Patients can learn more about treatment options as they are depicted~     visually so as to better assist them in understanding treatment risks and benefits to~     confidently make a well-informed decision. Primarily, the study will evaluate efficiency when~     using the education video medium. The study will also evaluate the effectiveness of the video~     medium as an aid to decision making in addition to standard of care in comparison to the~     standard of care alone. Additionally, the study will evaluate both patients' and~     dermatologists' satisfaction of the educational intervention.~   "
107667|NCT02158130|"~     The proposed study seeks to better understand the role of body weight, energy expenditure,~     and energy intake as mechanisms of body weight gain during detraining following aerobic~     exercise. It is hypothesized that participants in the higher dose exercise group will have~     greater body weight gain compared to the lower exercise dose and control group from wk 24 to~     wk 76 follow-up.~   "
107628|NCT02158637|"~     This study is being done to try out questions from a large set of questions called the~     Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events~     (PRO-CTCAE). The PRO-CTCAE is a set of questions which asks patients about their symptoms.~     This study will look at properties of these questions and will provide information about how~     these questions can be improved for research studies. PRO-CTCAE questions were developed~     under a contract from the National Cancer Institute (NCI) to allow patients to self-report~     symptoms in future cancer clinical trials. Patients with cancer receiving treatment will~     complete a web-based questionnaire containing PRO-CTCAE questions and a paper booklet~     containing a commonly used questionnaire for assessing quality of life, functioning, and~     symptoms at two visits one to six weeks apart. Some patients will additionally complete~     web-based questionnaires containing PRO-CTCAE questions weekly for four to five weeks, while~     completing a daily questionnaire containing PRO-CTCAE questions using an automated telephone~     system. Lastly, a small number of patients will complete only a single visit in which a~     web-based, telephone-based, and paper-based questionnaire containing PRO-CTCAE items is~     completed in addition to a paper booklet containing a commonly used questionnaire for~     assessing quality of life, functioning, and symptoms. The primary hypothesis is that scores~     for PRO-CTCAE questions will differ between patients with high versus low general well-being~     as measured by your doctor using a scale called the Eastern Cooperative Oncology Group~     Performance Score.~   "
107629|NCT02158624|"~     To establish the correlation between visual acuity improvement and QOL measurement after~     ranibizumab treatment for AMD patients.~   "
107630|NCT02158611|"~     This project aims to provide more treatment options to suicide patients to further enhance~     the holistic medical services in Far Eastern Memorial Hospital. It focuses on high-risk~     cases, especially those whose suicidal behaviors are triggered by interpersonal/or emotional~     problems because psychological counseling or interpersonal growth groups of services have~     been shown to be beneficial to this population.~   "
107631|NCT02158598|"~     This is a 6-month cross-over trial of vitamin D supplementation in 38 healthy men and women~     aged 18 years and older. The primary aim is to compare the change in serum 25(OH)D~     concentration following vitamin D supplementation with chewable tablets versus pills.~     Secondary aims are to evaluate satisfaction and adherence to the vitamin D chewable tablet~     supplement. Questionnaires on physical activity, sunlight exposure and dairy product~     consumption will be administered to adjust for confounding factors. A questionnaire will be~     administered to assess satisfaction and pill count to evaluate adherence to treatment. This~     research intends to test the hypothesis that the vitamin D chewable tablet supplement is as~     effective as a traditional vitamin D pill supplement to increase serum 25(OH)D~     concentrations.~   "
107632|NCT02158585|"~     This double-blinded study evaluates the frequency of vertigo attacks and the quality of life~     of patients diagnosed with Ménière's disease after being randomly assigned to take a placebo~     or lamotrigine.~   "
107633|NCT02158572|"~     Study of the efficacy of a contraceptive patch in 2100 healthy women for up to one year.~   "
107634|NCT02158559|"~     This study focused on the effect of Danhong injection on microcirculation in the treatment of~     patients with STEMI(ST-elevation myocardical infarction) after the PTCA surgery.~   "
107635|NCT02158546|"~     This study will evaluate the efficacy and safety of ALKS 5461.~   "
107636|NCT02158533|"~     This study will evaluate the efficacy and safety of ALKS 5461.~   "
107637|NCT02158520|"~     This randomized phase II trial studies how well nab-paclitaxel and bevacizumab or ipilimumab~     works as first-line therapy in treating patients with stage IV melanoma that cannot be~     removed by surgery. Drugs used in chemotherapy, such as nab-paclitaxel, work in different~     ways to stop the growth of tumor cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Bevacizumab may stop the growth of tumor cells~     by binding to a protein called vascular endothelial growth factor (VEGF) and by preventing~     the growth of new blood vessels that tumors need to grow. Ipilimumab blocks a substance~     called cytotoxic T-lymphocyte-associated antigen-4 (CTLA4) on the surface of T cells and may~     help the immune system kill cancer cells. It is not yet known whether nab-paclitaxel and~     bevacizumab is more effective than ipilimumab in treating melanoma.~   "
107638|NCT02158507|"~     This study will evaluate the effectiveness and safety of the combination of two drugs,~     Veliparib and Lapatinib, given to participants with metastatic triple negative breast cancer~     that have undergone previous treatment. Veliparib is an investigational drug and has not been~     approved by the FDA while Lapatinib has been approved by the FDA for another type of breast~     cancer. All eligible participants will receive the study medications and not a placebo.~   "
107639|NCT02158494|"~     The investigators hypothesis is that electrical stimulation to the tongue that directly~     stimulates two cranial nerve nuclei (Trigeminal and Facial Nerve Nuclei), will excite neural~     impulses to the brainstem and cerebellum. The investigators call this cranial nerve~     non-invasive neuromodulation (CN-NINM). The activation of these structures induces~     neuroplasticity when combined with specific physical, cognitive and/or mental exercises,~     promoting recovery of selected functional damage such as problems with balance or walking.~      44 subjects will be recruited for 2 weeks of intensive In-Lab Balance and Gait Training~     followed by 12 weeks of intensive Home Training with weekly In-Lab check sessions. Half of~     the subjects will use CN-NINM in conjunction with the exercise. Half of the subjects will use~     very low level stimulation in conjunction with the exercise, and will serve as a control~     group.~   "
107640|NCT02158481|"~     The main aim of the study is to investigate the effects of dietary ingredients (polyphenols~     and carotenoids) on vascular function during acute glucose load. Each subject will receive 4~     weeks of intervention with test product or placebo product after a dietary restriction run-in~     period of 14 days. Subjects will be challenged with an oral glucose tolerance test (OGTT)~     immediately after the run-in phase and at the end of the intervention phase. During the OGTT,~     blood samples will be taken at regular intervals.~      The study will be conducted in subjects with impaired glucose tolerance.~   "
107641|NCT02158468|"~     The LIPSIA-Conditioning trial is an investigater initiated, randomized, single-center study~     that will assess the effect of different intrahospital conditioning protocols on myocardial~     damage assessed by MRI in patients with acute ST-elevation myocardial infarction.~      The following groups will be compared:~        1. Combined intrahospital pre- plus postconditioning versus~        2. Postconditioning versus~        3. Control~   "
107642|NCT02158455|"~     The investigators have developed a novel technique for saphenous vein graft harvesting for~     coronary artery bypass grafting (CABG) where the graft is harvested with a pedicle of~     surrounding tissue. A randomized trial has shown a significantly higher patency rate for vein~     grafts harvested with this new methode compared to conventional harvesting technique 8.5~     years after surgery (90 vs 76 %). In 2004 the investigators started a prospective randomized~     trial comparing patency between vein grafts harvested with surrounding tissue and radial~     artery grafts. The result showed that vein grafts harvested with surrounding tissue had a~     significantly higher patency rate compared to radial artery grafts 3 years after surgery (98~     vs 84 %). The present study is a long-term follow-up (8 years) of the patients included in~     the second randomized trial. The hypothesis is that vein grafts harvested with surrounding~     tissue have a significantly higher patency rate compared to radial artery grafts 8 years~     after surgery.~   "
107643|NCT02158442|"~     The use of the Percutaneous Isolated Limb Procedure (PILP) which enables the use of existing~     antibiotic therapies in a more targeted and concentrated fashion in patients with diabetes~     who have a significant lower limb infection and it is deemed that IV antibiotics are needed~     in order to salvage the limb or life.~   "
107644|NCT02158429|"~     1. A randomized trial of 3-dimensional vs. 2-dimensional ultrasound, comparing scores on~          the Maternal Antenatal Attachment Scale (MAAS), a validated instrument measuring~          maternal attachment as a marker of maternal bonding. The hypothesis is that~          3-dimensional ultrasound is better at eliciting maternal attachment than 2-D~        2. To assess changes in maternal confidence to stop using drugs and quit/reduce smoking~          with 3-D vs. 2-D ultrasound. Again, the hypothesis is that 3-D ultrasound will improve~          the woman's confidence to stop using substances.~        3. To evaluate if 3-D ultrasound improves paternal attachment as measured by pre- and post-~          scores on the Paternal Antenatal Attachment Scale (PAAS). The hypothesis is that 3-D~          ultrasound will have a greater effect on PAAS scores than 2-D.~   "
107645|NCT02158416|"~     The planned minimal risk study is a blinded study on consecutive transfusable platelet~     products. The aim of the study is to evaluate the quality of platelet components sampled~     prior to transfusion.~      The primary patient transfusion outcome in this study is the 1-hour corrected count increment~     (1 hr CCI), which is a widely accepted clinical outcome measure. Platelet products will be~     sampled for ThromboLUX testing before being sent from the blood bank to the treatment center.~     After receipt at the treatment center, the platelet products will be used as per regular~     clinical practice, and the outcome data from each patient will be collected. At the end of~     the study, TLX Scores will be compared to the transfusion outcomes to determine if a low TLX~     Score is associated with a poor transfusion outcome.~      During the course of the study, the TLX Score will not be known to the clinicians, or~     utilized in any way to decide if the platelet product should be transfused.~   "
107646|NCT02158403|"~     The purpose of this study is to assess how often blood clots form in the FDA-approved~     HeartMate® II (HM II) Left Ventricular Assist Device (LVAD) and to identify risks related to~     clotting within the pump.~   "
107647|NCT02158390|"~     Children with Down syndrome (DS) have greater difficulty acquiring expressive language than~     is predicted by their general cognitive abilities and language comprehension (Miller, 1999).~     To date, interventions to improve communication outcomes for children with DS have met with~     only modest success. The proposed study is a randomized controlled trial of an early~     communication intervention combining two evidence-based treatments that teach expressive~     communication (Enhanced Milieu Teaching; EMT) and joint attention/symbolic play (Joint~     Attention Symbolic Play Engagement and Regulation; JASPER) using a dual mode (words +AAC).~     The intervention (a) teaches the foundations of communication (joint attention, play), (b)~     builds on positive child characteristics of social attention, (c) uses naturalistic~     strategies to increase the rate and complexity of communication and increase task engagement,~     (d) addresses the potential value of adding visual support (AAC) to spoken communication, and~     (e) includes parents as implementers of the intervention to promote generalization across~     settings and activities, and to ensure maintenance over time. It is hypothesized that~     children with DS enrolled in the intervention will have better language and communication~     skills at the end of treatment and followup than children in the BAU comparison group.The~     study will enroll 82 30 to 54 month old children with DS who have fewer than 20 words.~     Examining predictors of response to treatment and the effects of treatment on executive~     functioning will inform both theory and practice.~   "
107648|NCT02158377|"~     Randomized-controlled, multicenter study of Trabecular Metal (TM) and Tapered Screw-Vent~     (TSV) dental implants loaded early in maxillary and mandibular sites.~   "
107649|NCT02158364|"~     The purpose of this survey is to assess the safety of freeze-dried live attenuated measles~     and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) (freeze-dried live~     attenuated measles and rubella combined vaccine Takeda) in terms of the occurrence of~     unknown/known adverse drug reactions and factors that may influence the safety of vaccinees~     after the second vaccination.~   "
107650|NCT02158351|"~     Several experimental data suggest that gut-derived endotoxin and GM composition can act as a~     second hit or insult to convert hepatic SS to NASH and cause both local hepatic and~     systemic inflammation.This study's aim is to analyze microbiota diversity, providing~     information both on intestinal microbial composition and on the metabolic processes linked to~     them. In addition, we will correlate, for the first time, GM composition to hepatic and white~     adipose tissue gene expression patterns of interest and serum and fecal markers possibly~     related to impaired fat storage and inflammation. We aim to provide preliminary data to~     design future intervention studies with pre- or probiotics or bile acid derivatives to~     prevent/treat inflammation and fibrosis in NAFLD patients.~   "
107662|NCT02158195|"~     Autoimmune hemolytic anemia (AIHA) is an auto-immune disease mediated by specific antibodies~     targeting red blood cells. Its pathogenesis is not completely understood, and the role of T~     cells have been rarely studied.~      The aim of this study is to compare the frequency of circulating T cells, T cell polarization~     and functions, notably regulatory T cells, during warm AIHA by comparison to healthy~     controls.~      The role of treatments, such as steroids, will also be determined in patients with warm AIHA.~   "
107663|NCT02158182|"~     The aim of this study is to determine whether lactulose, L-ornithine L-aspartate, and~     rifaximin are effective in the prevention of the development of hepatic encephalopathy in~     cirrhotic patients with acute variceal bleeding~   "
107651|NCT02158338|"~     Six studies have preceded this project. Three studies suggested that there is a significant~     connection between pediatric asthma and disruptions in maternal-infant bonding (Feinberg,~     1988; Schwartz, 1988; Pennington, 1991). Three studies suggested that children with asthma~     benefit from a type of therapy that improves bonding with their mothers (Madrid, Ames,~     Skolek, & Brown, 2000; Madrid, Ames, Horner, Brown, & Navarrette, 2004; Madrid, Pennington,~     Brown & Wolfe, 2011).~      This study proposes to study in a more thorough fashion the question of the incidence of~     bonding disruptions with between mothers and their children with asthma. This time there will~     be a larger sample, and more stringent criteria will used in assigning children to the asthma~     cohort. Through questions answered by mothers whose children have been said to have asthma,~     we will be able to decide if the children's respiratory conditions are likely to be~     attributable to asthma or more likely reflective of another respiratory condition such as~     vocal cord dysfunction or anxiety related hyperventilation (Anbar, 2014).~   "
107652|NCT02158325|"~     Different capsulorhexis size results in different capsular outcome when treating pediatric~     cataract, and there should be an appropriate capsulorhexis size for the best capsular~     outcome.~   "
107653|NCT02158312|"~     Post-stroke sensorimotor recovery largely depends on ipsilesional and interhemispheric motor~     circuit reorganization. Transcranial direct current stimulation (tDCS) may be used to enhance~     after-effects of rehabilitation through membrane polarization modulation. In this~     double-blind, crossover randomized controlled trial, we aim to investigate whether~     single-session, bihemispheric tDCS to the primary motor cortex (M1) in combination with upper~     extremity rehabilitation therapy modulates ipsilesional motor circuit excitability using~     transcranial magnetic stimulation (TMS) and magnetoencephalography (MEG) measures.~   "
107654|NCT02158299|"~     After Axillary lymphadenectomy for breast cancer there are not few patients showed seroma~     formation and it can not be ignored.Investigators aimed to study two new methods of~     application of Microfibrillar Collagen Hemostat Flour and OK-432 to reduce seroma formation~     and to verify the efficacy and safety of these two applications.Try to prove them as~     beneficial supplements for axillary lymphadenectomy of breast cancer.~   "
107655|NCT02158286|"~     Retention of the gastric tube after esophagectomy is a clinically important problem, and~     there is a need of a simple method to evaluate emptying rate from the gastric tube after~     esophagectomy. Scintigraphy is the golden standard of measuring emptying rate from the~     gastric tube. In non-operated patients, paracetamol clearance technique have been widely used~     for measuring gastric emptying rate. There is no validation however if paracetamol clearance~     technique can be used for measuring emptying rate of the gastric tube. The investigators aim~     of this pilot- study is to validate paracetamol clearance technique to scintigraphy for~     measuring emptying rate from the gastric tube and to evaluate if there is a correlation~     between symptoms of retention and quality of life with the emptying rate.~   "
107656|NCT02158273|"~     The primary hypotheses under test are that alcohol dependent subjects treated with~     fenofibrate will report decreased craving for alcohol following cue-exposure in the~     laboratory and report less drinking post treatment relative to placebo.~   "
107657|NCT02158260|"~     It is a single center, prospective and self-controlled trial. We'd like to explore a new~     method by changing position to reduce gastric missing areas in Capsule Endoscopy(CE)~   "
107658|NCT02158247|"~     1. Airway length from the medial incisor to carina is divided into four segments ; the~          length from medial incisor to mouth angle, mouth angle to epiglottis, epiglottis to~          vocal cords and vocal cords to carina.~        2. Determining the mean length of each segments with the direct laryngoscope,~          videolaryngoscope and fiberoptic bronchoscope at the time of endotracheal intubation.~        3. Making a new formula to determine the proper individualized depth of intubation on the~          basis of the length of segments~        4. Virtual experiment : comparing the new formula with conventional method of determining~          the depth of endotracheal intubation~   "
107659|NCT02158234|"~     This study involves another course of radiation (called re-irradiation) to the participant's~     tumor. The type of radiation is called stereotactic body radiation therapy (SBRT). The~     purpose of this study is to compare the effects, good and/or bad, of different doses of SBRT~     given along with the chemotherapy drug, cisplatin. The researchers want to see which dose of~     radiation will work best in controlling the growth of head/neck cancer. The usual treatment~     for head/neck cancer that has grown is surgery and/or more radiation with various~     chemotherapy drugs.~   "
107660|NCT02158221|"~     The investigators hypothesized that migraine without patients with many genetic loci~     associated with migraine (high genetic load) would be more sensitive and get provoked more~     migraine attacks by PACAP compared to patients with few genetic loci associated with migraine~     (low genetic load).~   "
107661|NCT02158208|"~     The research hypothesis is that T lymphocytes CD8 play a role in the physiopathology of~     Horton's disease.~      At the inclusion visit, patients will have, as is the case in the usual strategy:~        -  A complete clinical examination carried out by the doctor in charge of the patient~        -  ESR, and CRP and fibrinogen assay~        -  A full blood count for leukocytes and lymphocytes~        -  A biopsy of the temporal artery (TAB) to screen for signs of vascularitis, suggesting~          Horton's disease. The clinician in charge of the patient will decide if a second biopsy~          is necessary. The biopsy will be sent to and analysed at Anatomy and Pathological~          cytology service. Immunohistochemical analyses will be done if the TAB is positive.~      In addition to the standard clinical examination and complementary examinations relative to~     the patients' pathology, the following will be done:~        -  Lymphocyte immunophenotyping for the quantity of T CD4 (cluster of differentiation 4)~          and CD8 lymphocytes, B lymphocytes and natural killer lymphocytes. This will make it~          possible to calculate the absolute value for different T lymphocyte populations.~        -  A blood sample drawn into a dry 5 mL tube (large yellow) to isolate the serum, which~          will be stored at -80°C for future assays for cytokines and other biomarkers of interest~          for Horton's disease.~        -  16 blood samples drawn into 6 mL heparinized tubes (large green). These will be used~          immediately for cytometric and functional analyses.~   "
107664|NCT02158169|"~     The aim of this study is to describe, in a real-life context, the impact of an epoetin alpha~     biosimilar, Retacrit®, on anaemia in patients receiving chemotherapy, according to~     concomitant iron supplementation.~   "
107668|NCT02158117|"~     Overdose with potential deadly outcome is a serious problem among opioid abusers, not least~     in Norway. The annual death toll from overdose is about 250, twice the annual death toll from~     traffic accidents. Those who inject heroin or other opioids are considered to have the~     highest risk for death from overdose. To save lives, immediate treatment with a μ-opioid~     antidote such as naloxone is required. Usually naloxone is injected into a muscle or a blood~     vessel. Administration of naloxone via the nose has been suggested as an alternative for use~     by emergency teams and possibly also bystanders. This is not only an easier way to give~     naloxone, but would also eliminate the risk for needle stick injuries and blood~     contamination. A pilot study in this hospital has shown no significant side effects or~     adverse reaction. While significant benefits are expected from developing an adequately~     formulated naloxone nasal spray for pre-hospital use, the risks to participants are minimal.~     Therefore this preclinical study in healthy volunteers will be undertaken.~   "
107669|NCT02158104|"~     Pain after dry needling or injection in the muscle is a frequent secondary effect in the~     treatment of myofascial pain syndrome. In this trial pain and sensitivity will be assessed~     during a 72 hours follow up period. Factors that may contribute to higher levels of pain or~     sensitivity will be evaluated.~   "
107670|NCT02158091|"~     This research study is evaluating a new drug called IPI-145 in combination with the standard~     drugs fludarabine, cyclophosphamide, and rituximab (FCR), as a possible treatment for chronic~     lymphocytic leukemia (CLL).~   "
107671|NCT02158078|"~     The purpose of the study is to obtain an assessment (efficacy, safety, and patient reported~     outcomes) of basal bolus insulin delivery with PaQ in insulin-using patients with type 2~     diabetes mellitus (T2DM).~   "
107672|NCT02158065|"~     The purpose of this 3 month randomized intervention study is to investigate the additional~     effect of a physical activity telecoaching program on physical activity in patients with~     COPD, compared with usual care.~   "
107673|NCT02158052|"~     This pilot trial offers the unique opportunity for both the treatment of multiple myeloma or~     systemic AL amyloidosis for which hematopoietic stem cell transplantation would be ordinarily~     indicated and the reversal of end-stage renal failure, while avoiding the risks associated~     with long-term standard anti-rejection therapy used in renal transplantation. The primary~     objectives of this study are to assess renal allograft tolerance (that is, the acceptance of~     the kidney without the need for anti-rejection therapy), assess anti-tumor response rates in~     multiple myeloma and AL amyloidosis, and assess complication rates for genetically (HLA)~     matched related donor combined bone marrow and kidney transplantation using a low dose total~     body irradiation based preparative regimen.~   "
107674|NCT02158039|"~     Cystic tumors of the pancreas are fluid-filled growths. They are often treated by surgical~     removal. A safe and effective non-surgical treatment is desirable. Ethanol (alcohol)~     injection may treat cysts by killing the lining cells of the cyst, and is an accepted~     treatment for cysts of other organs. In this study, participants with pancreatic cysts~     underwent endoscopic ultrasound (EUS) guided ethanol injection of pancreatic cysts. This was~     a pilot study to assess safety and efficacy.~      The hypotheses of this study were 1) complications of EUS guided ethanol injection requiring~     hospitalization will occur in <10% of subjects, and 2) EUS guided ethanol injection, with~     retreatment as necessary, will ablate at least 50% of pancreatic cysts.~   "
107675|NCT02158026|"~     1000 women with infertility who are already decided to be treated with ICSI will be subjected~     to full history taking and clinical examination. On the second day of menstruation serum FSH,~     LH, Prolactin and Oestradiol will be assessed and the antral follicular count (AFC) will be~     assessed using a vaginal ultrasound scan. AFC will be defined as the number of follicles~     measuring 3-10mm.~      All patients will have standard pituitary down-regulation followed by (Human menopausal~     gonadotrophin (HMG) stimulation until the day of (Human chorionic gonadotrophin (HCG)~     administration. On the day of HCG administration, ovarian ultrasound scan will be performed~     using a transvaginal probe and the Preovulatory follicle count (PC) will be assessed, (PFC)~     is defined as number of follicles measuring≥16mm. Follicular sensitivity index (FSI) will be~     calculated as: (FSI =PFC*10000/AFC*Total dose of FSH)~   "
107676|NCT02158013|"~     The purpose of this study is to investigate the effect of Levorag Emulgel compared with~     diltiazem gel on the healing of chronic anal fissures.~   "
107677|NCT02158000|"~     To notify the effect of aspiration of excessive endometrial fluid in addition to Diosmin in~     cases undergoing intracytoplasmic sperm injection (ICSI) cycles.~   "
107678|NCT02157987|"~     Epistaxis are present in over 90 % of patients with Rendu - Osler . They involve no~     significant difference 2 sexes. They often appear in childhood and adolescence and are~     present in three-quarters of patients at the age of 20 years. These epistaxis increasing in~     frequency and volume to the age of 60 in 2/3 of patients. Epistaxis are spontaneous ,~     repetitive and recurring . They are highly variable in duration, intensity and frequency of~     occurrence . Some patients may have more than 40 monthly episodes with mean duration of 5~     minutes of bleeding and chronic anemia and can sometimes acute anemia with transfusions need~     to be source. These epistaxis stigmatize patients and inevitably affect their quality of life~     and social skills . The various proposed ( cauterization , intra- mucosal injections, laser~     selective hémostatses , embolization or surgical dermoplasties ) allow for some short-term~     remissions . Bevacizumab is an antiangiogenic use in the treatment of colorectal cancers . It~     is also used in ophthalmology intravitreal to reduce vascular proliferation in glaucoma~     retinopathy and certain corneal neovascularization. In 2009, Prithviraj reported the use of~     bevacizumab injection to treat pulmonary arteriovenous malformations in a patient with Rendu~     - Osler . The result is doubly interesting including a saving action on epistaxis which~     decrease in frequency and duration. This communication prompted the authors to focus more on~     this medication. The product has been used in local submucosal injection intranasal laser was~     coupled with satisfactory results objectified by a decrease in the number of epistaxis ,~     reducing blood transfusions and improved social lives. The use of local instillation~     bevacuzimab represents a way forward for the treatment of these epistaxis.~   "
107973|NCT02154139|"~     The purpose of this survey is to examine the safety and efficacy of long-term use (96 weeks)~     of leuprorelin acetate SR (slow release) 11.25 milligram (mg) for injection (Leuplin SR 11.25~     mg for Injection) in premenopausal breast cancer patients in daily medical practice, as well~     as to examine factors that can influence the safety and efficacy of treatment with~     leuprorelin acetate SR 11.25 mg for injection (Leuplin SR 11.25 mg for Injection).~   "
107679|NCT02157974|"~     Women with polycystic ovarian syndrome (PCOS) have increased rates of hepatic steatosis~     compared to weight similar women with regular menses. It is unclear if this is related to~     high testosterone or insulin resistance. The investigators will assess hepatic glucose~     release, rates of lipolysis and hepatic de novo lipogenesis in the fasted and postprandial~     state to determine if alterations in the processes contribute to hepatic steatosis. Subjects~     will be overweight, sedentary girls with or without PCOS who are not receiving medical~     therapy for insulin resistance, or PCOS.~   "
107680|NCT02157961|"~     This is an observational study to assess the health behavior of Physicians from medical~     practices in Germany. Physicians will be asked by a questionnaire (self-report) on health~     behavior, self-diagnostics and self-medication in case of sickness. We will send the~     questionnaire to 1000 General Practitioners and to 300 medical specialists in Germany. We~     expect a response rate of 25-30 %. After electronically data-entry we will run a descriptive~     analysis for primary outcome. Results may provide a better understanding of the Physicians~     health behavior.~   "
107681|NCT02157948|"~     This study will compare the effect of denosumab produced by two different manufacturing~     processes on bone mineral density at the lumbar spine in postmenopausal women with~     osteoporosis.~   "
107682|NCT02157935|"~     Comparing the efficacy of Symbicort® pMDI and Formoterol Turbuhaler in reducing exacerbations~     in patients with Chronic Obstructive Pulmonary Disease (COPD).~   "
107683|NCT02157922|"~     The purpose of the study is assessment of efficacy and safety of OligoG as a dry powder~     formulation, in adult subjects with cystic fibrosis.~   "
107684|NCT02157909|"~     The purpose of this study is to demonstrate that Lotrafilcon B AIR OPTIX® AQUA sphere~     modified design lenses are noninferior to Lotrafilcon B AIR OPTIX® AQUA in overall lens fit~     by comparing the percent of subjects satisfying the no re-fit criteria in each treatment~     group.~   "
107685|NCT02157896|"~     Vascular endothelial growth factor (VEGF) and Endostatin (ES) participate angiogenesis after~     cerebral ischemia. Circulating endothelial progenitor cells (EPCs) also play a crucial role~     in neovascularization and tissue repair after acute ischemic stroke (AIS). The investigators~     sought to compare the expression of VEGF and ES in serum and the circulating EPCs in patients~     after AIS with that of healthy control subjects. The investigators obtained peripheral blood~     and serum samples from study subjects. EPCs in blood samples from AIS patients and healthy~     controls were quantified by flow cytometry 1 day, 3 days, 5 days and 7 days after AIS. VEGF~     and ES were measured by enzyme linked immunosorbent assay at the same time points. The~     relation between them and the relation of them to prognosis of such patients with acute~     ischemic stroke were assessed.~   "
107686|NCT02157883|"~     This is a 2 part study in patients with EGFRm+ non small cell lung cancer (NSCLC), whose~     disease has progressed on an EGFRm TKI, who are refractory or resistant to standard therapy.~     Part A will assess the effect of multiple oral doses of itraconazole on the single dose~     pharmacokinetic (PK) parameters of AZD9291. On completion of Part A, patients may continue to~     take AZD9291 tablets (Part B) following the collection of the 216 hour sample on Day 19 if~     they and the Investigator deem it appropriate, until such time as their disease progresses,~     the Investigator believes they are no longer deriving clinical benefit, or they stop taking~     AZD9291 for any other reason.~   "
107687|NCT02157870|"~     Multi-Phase study (I/II) that did not progress to Phase II of clinical trial, terminated~     early due to low accrual, separate ClinicalTrials.gov Registration NCT00102622 for Phase I of~     study:~      Phase I:~        -  Enrollment of up to 24 subjects in 8 cohorts of three subjects to one of three~          combinations of intraperitoneal (IP) tgDCC-E1A + intravenous (IV) paclitaxel by the~          continuous reassessment method (CRM) will be sufficient to establish the MTD~        -  The single agent paclitaxel cohort will consist of 24 subjects~      Phase II:~        -  Enrollment of up to 20 subjects to one of three combinations of IP tgDCC-E1A + IV~          paclitaxel decided by Phase I.~        -  The single-agent paclitaxel cohort will consist of 20 subjects.~   "
107688|NCT02157857|"~     The aim of our study is to investigate if CK19 mRNA-detection via OSNA can accurately detect~     lymph node metastases in lung cancer patients using EBUS-TBNA samples.~   "
107689|NCT02157844|"~     Obstructive sleep apnea (OSA) is the most common type of sleep apnea and is caused by an~     obstruction of the upper airways. The obstruction results in periods of intermittent hypoxia~     and re-oxygenation, which lead to increased oxidative stress, increased inflammation,~     endothelial dysfunction, and insulin resistance. Chronic obstructive pulmonary disease (COPD)~     is a lung disease that leads to poor airflow. This disease leads to systemic hypoxia, reduced~     oxidative capacity, and increased inflammation. The direct cause of OSA and COPD is unclear,~     but OSA and COPD may be linked to other comorbid conditions such as obesity and type II~     diabetes. Upon onset of OSA and COPD, metabolic disturbances associated with obesity and type~     II diabetes can be exacerbated.~      Obesity is a condition characterized by an increase in visceral fat, elevated plasma levels~     of free fatty acids, inflammation, and insulin resistance. Although the effects of body fat~     distribution have not been studied in these patients, an increase in both subcutaneous and~     abdominal fat mass in non-OSA older women was shown to increase morbidity and mortality.~     Fat/adipose tissue is an active tissue capable of secreting proinflammatory cytokines such as~     tumor necrosis factor (TNF)-alpha and interleukin (IL)-6, reactive oxygen species and~     adipokines. Particularly, abdominal fat is a prominent source of pro-inflammatory cytokines,~     which contributes to a low grade, chronic inflammatory state in these patients. Additionally,~     an increased inflammatory state is associated with reduced lean body mass, and together with~     elevated circulating free fatty acids may increase the occurrence of lipotoxicity and insulin~     resistance. Thus, increased fat deposition is associated with a poor prognosis in OSA and~     COPD patients and therefore it is of clinical and scientific importance to understand the~     changes in fat metabolism and digestion as a result of OSA and COPD.~      It is therefore our hypothesis that fat synthesis and insulin resistance is increased and~     whole body protein synthesis is decreased in OSA and COPD patients, leading to a poor~     prognosis.~   "
107690|NCT02157831|"~     Patients who had clinical benefit following a single infusion of CP-870, 893 on Protocol UPCC~     10903 will receive a single repeated infusion of CP-870,893 at the same dose given on UPCC~     10903 intravenously.~   "
107701|NCT02157688|"~     The folliculitis decalvans (FD) is an orphan disease , common in consultation specialized on~     scalp. This disease is currently not curable, responsible for significant for patients. The~     pathophysiology is poorly understood, Staphylococcus aureus (SA) appears to play a role,~     never previously studied, and the study will attempt to clarify it.~      Controversies in the literature on the pathophysiological hypotheses can be summed up as~     follows :~      FD is it an infectious folliculitis where SA (almost always found on the lesions plays a~     direct role possibly aided by a lack of local immune protection , or is it a pustular~     inflammatory unknown cause where the SA has no direct role but is a cofactor or a simple germ~     superinfection.~      Our study has plans to bring new evidence to help decide between these two opposite but not~     mutually exclusive concepts .~   "
144172|NCT01680250|"~     The purpose of this study is to evaluate the effectiveness and safety of Sirolimus in~     reducing liver volume in autosomal dominant polycystic kidney disease.~   "
107691|NCT02157818|"~     1. Appropriate sedation is needed for medical diagnosis, treatment, and the safety for~          patients. In non-surgical approaches, benzodiazepines are broadly used for ideal sedated~          status for patients.~             -  However, especially in bronchoscope procedure, continuous monitoring of oxygen~               saturation is needed to prevent hypoxia due to respiratory distress induced by~               benzodiazepine.~             -  A alpha-2 agonist, dexmedetomidine, which has similar sedative effect, but has less~               adverse effect of respiratory distress compared to previous agents, was introduced.~        2. It is necessary to compare the efficacy and safety of dexmedetomidine with that of~          midazolam in ultrasound guided transbronchial needle aspiration (EBUS-TBNA).~             -  Double blind randomized trial~             -  Primary outcome: The number and duration of desaturation, volume of sedative, any~               use of rescue midazolam, and Ramsay Sedation Scale (RSS) score (for efficacy), and~               hypertension, tachycardia, any need for mandible support or manual ventilation, and~               any need for intubation (for safety).~   "
107692|NCT02157805|"~     This project aims to assess the impact of technological processes of meat, as cooking~     conditions, on amino acid bioavailability and protein metabolism. The hypothesis is that,~     even if meat is considered as a good provider of fast proteins and so could be useful to~     prevent sarcopenia in aged people, the manner it is cooked can change its digestion rate and~     amino acids bioavailability for muscle synthesis.~   "
107693|NCT02157792|"~     An Open-Label, First-in-Human Study of the Safety, Tolerability, and Pharmacokinetics (PK) of~     M6620 in Combination With Cytotoxic Chemotherapy in Participants With Advanced Solid Tumors~   "
107694|NCT02157779|"~     Excessive and poorly controlled anger is one of the most common problems experienced by war~     Veterans. The consequences can be severe, including increased risk for divorce, domestic~     violence, job loss and instability, and other serious impairments in family, social, and~     occupational functioning. Availability of effective treatments is critical to reducing the~     adverse effects of anger in Veterans. The investigators propose to conduct a controlled study~     to determine whether a cognitive behavior treatment that has been adapted for treating anger~     problems in Veterans of Iraq and Afghanistan results in improved outcomes compared to a~     supportive therapy. Results will be examined for improvement in anger, functioning, and~     quality of life at end of 12 weekly sessions, and at 3 and 6 months following treatment.~   "
107695|NCT02157766|"~     The Wisconsin Center for the Neuroscience and Psychophysiology of Meditation will be a highly~     focused center dedicated to novel and cutting edge research on the mechanisms by which~     meditation works. The core set of hypotheses for this Center focus on the mechanisms of two~     common meditation practices: Mindfulness Meditation (MM) and Loving-Kindness/Compassion~     Meditation (LKM-CO), both taught in Mindfulness-Based Stress Reduction (MBSR). The~     investigators will study both Long-Term Meditators (LTMs) as well as meditation-naïve~     participants (MNPs). The latter group will be randomly assigned to MBSR, a rigorously matched~     comparison intervention called the Health Enhancement Program (HEP; MacCoon et al., 2012), or~     to a Wait List (WL) control group. This will give us a comprehensive view of changes that are~     produced by meditation practices per se, changes generically associated with interventions~     designed to promote well-being, and changes that might be effects of repeating testing~     protocols across multiple occasions. In addition, the inclusion of both novice and~     experienced meditators provides a wide range of practice experience that will provide~     critical information on dose-related effects, information that is lacking in the research~     literature today.~      Each of the projects is focused on examining the brain mechanisms and peripheral biological~     correlates of meditation. Project 1 (Davidson) will examine the impact of the explicit use of~     mindfulness and loving-kindness/compassion strategies on emotion regulation, specifically~     neural, biobehavioral and hormonal indices of reactivity to and recovery from pictures of~     human suffering and flourishing. Project 2 (Busse) will investigate the brain to periphery~     pathways through which psychological factors contribute to the expression of asthma symptoms.~     In addition, it will examine the efficacy of meditation training in reducing the inflammatory~     response to an allergen in asthmatic individuals by reducing the reactivity of~     emotion-related neural circuitry. Project 3 (Tononi) will examine whether the previously~     reported increase in gamma oscillations during Non-REM (NREM) sleep in meditators is~     associated with changes in sleep mentation (Ferrarelli et al. 2013). In addition, project 3~     will examine relations between meditation-induced changes in brain activity during sleep and~     brain activity and cognitive function during wakefulness.~   "
107696|NCT02157753|"~     As a tertiary hospital the Traumatology department at the Kantonsspital Aarau looks after~     about 500 fracture patients hospitalized with an age over 50 years a year. First, we were~     interested in the effective rate of osteoporotic fractures in this cohort. As to this~     objective we offered subsequent diagnostics in suspected patients. 2012 we introduced a~     diagnostic pathway for every patient over 50 years of age with a fracture, including dual~     energy x-ray absorptiometry (DXA), a questionnaire about risk factors concerning osteoporosis~     and risk of fracture, the WHO Fracture Risk Assessment Tool (FRAX) and a laboratory workup~     focusing on this topic. Considering all these information we sent a detailed therapy-plan to~     the responsible General practitioner.~      The main goal of this study is to verify the persistence and compliance of the osteoporosis~     therapy 12-15 months after fracture and to clarify any obstacles potentially impeding therapy~     (prejudice, adverse events, contraindication overlooked, financial problems etc.). The~     investigators use a postal questionnaire provided to the patient and the general~     practitioner. Data collection is undertaken by a study nurse, in addition phoning for missing~     data by phone-call. With the aim to ameliorate the implementation of treatment, patients and~     general practitioners will be provided with the specifically tailored information found to be~     missing.~   "
107697|NCT02157740|"~     The purpose of this study is to determine whether teleconsulting would be effective and~     cost-effective by reducing the patients transportations and the use of emergency units for~     nursing home residents requiring emergent or elective care.~   "
107698|NCT02157727|"~     The purpose of this study is to determine whether telemedicine would be as effective as~     having a pediatrics ophthalmologist on site for screening examination of retinopathy in~     premature infants and would be cost-effective.~   "
107699|NCT02157714|"~     This multiple ascending dose study is to determine safety, tolerability, pharmacokinetics and~     immunogenicity of PRX002 in approximately 60 patients with Parkinson's disease.~   "
107700|NCT02157701|"~     This is a multicenter, randomized, double-blind, placebo-controlled, study in subjects with~     exercise-related knee pain/discomfort to determine the efficacy of a polyherbal capsule~     compared to placebo capsule in improving exercise capacity and overall parameters of joint~     health.~   "
107702|NCT02157675|"~     This study is a randomized, double-blind, placebo-controlled, crossover design study in~     healthy subjects to determine the effects of a polyherbal supplement on the signs and~     symptoms of delayed onset muscle soreness (DOMS) induced by eccentric exercise of the arm.~   "
109147|NCT02138786|"~     This is a multi-center, Phase 2, single arm, open-label study of oral selinexor monotherapy~     in patients in patients with Richter's transformation, arising in the setting of prior CLL,~     after at least one chemo-immunotherapy regimen for CLL.~   "
107703|NCT02157662|"~     The risk of developing clinical manifestations of ischemic heart disease is currently~     assessed by using integrated multifactorial prediction models based on the presence of~     non-modifiable risk factors, such as age, gender and a family history of early ischemic heart~     disease along with risk factors which are defined as conventional, such as arterial~     hypertension, hypercholesterolemia, cigarette smoking and diabetes mellitus.~      However, if the relationship between risk factors and ischemic heart disease clinical~     manifestations shows some limitations, the relation between risk factors and the coronary~     atherosclerosis process underlying most ischemic syndromes seems to be even weaker.~      In fact there is significant individual variability and the limits of such relationship are~     demonstrated by a non negligible number of subjects at the outliers of mean behaviour of the~     prediction model. At one outlier, in the presence of multiple risk factors, these subjects do~     not develop neither coronary events nor coronary atherosclerosis whereas, at the other,~     coronary events and disease occur in the absence of risk factors.This study aims at detecting~     new protection and susceptibility factors, thus enabling to formulate new etiopathogenetic~     hypotheses concerning coronary atherosclerosis and to identify new therapeutic targets.~   "
107704|NCT02157649|"~     The objectives of this study are (a) to determine if drug levels from a single dose of an~     extended-release Codeine/Guaifenesin tablet are similar to an immediate-release tablet given~     every four hours containing lower doses considered safe for over-the-counter use; (b) to~     evaluate if food affects the drug levels of this extended-release Codeine/Guaifenesin tablet~     after a single administration; and (c) to assess the safety and tolerability of the~     Codeine/Guaifenesin extended-release and immediate release tablet formulations.~   "
107705|NCT02157636|"~     Open-label, sequential dose escalation and expansion study of CPI-0610 in patients with~     previously treated multiple myeloma. CPI-0610 is a small molecule inhibitor of bromodomain~     and extra-terminal (BET) proteins.~   "
107706|NCT02157623|"~     The investigators will be testing whether aminolevulinate-based (Levulan™) Photodynamic~     Therapy (PDT) shows effectiveness in the treatment and prevention of cutaneous basal cell~     carcinoma (BCC) in Basal Cell Nevus Syndrome (BCNS) patients. Levulan™ PDT is an FDA-approved~     method widely used currently for squamous precancers of the skin. The investigators~     hypothesize that PDT will provide exceptional benefit in the BCNS population because PDT is~     nonmutagenic, nonscarring, and can be safely repeated many times. Additionally, the study~     will investigate whether there are any differences in tumor clearance between the Blu-U®~     (blue lamp) and Aktilite™(red lamp) therapies.~   "
107707|NCT02157610|"~     The goal of this research study is to compare a program called Motivation And Problem-Solving~     (MAPS) to the standard treatment to help participants with a history of cervical cancer or~     high-grade cervical dysplasia quit smoking.~   "
107708|NCT02157597|"~     Heart surgery in young children involves some risks. This study looks at a new type of~     monitor that may reduce these risks. Near Infrared Reflectance Spectroscopy (NIRS) aims to~     measure if enough blood reaches vital organs in the body. The investigators goal is to see if~     this shows problems developing sooner than usual. The investigators do not know at this time~     if they can improve the blood supply to the vital organs. The investigators main aim is to~     see which responses work the best. The NIRS monitor is approved by the U.S. Food and Drug~     Administration (FDA).~      The investigators will also follow the progress of recovery after surgery in the Cardiac~     Intensive Care Unit (CICU). This will find out if using the NIRS monitor improves the outcome~     for children.~   "
107709|NCT02157584|"~     This study is designed to evaluate the effect of food on the pharmacokinetics (PK) of~     telotristat ethyl and its metabolite LP-778902 relative to administration of single dose~     telotristat etiprate in the fasted state in healthy adult male and female subjects.~   "
107710|NCT02157571|"~     The purpose of this study is to use oral prulifloxacin to treat patient with Acute~     Exacerbations of Chronic Bronchitis and compare the effect with Levofloxacin.~   "
107711|NCT02157558|"~     The purpose of this study is to evaluate the effects of steady-state telotristat ethyl on the~     pharmacokinetics (PK) of single-dose fexofenadine in healthy subjects.~   "
107712|NCT02157545|"~     Pyridostigmine is a medication that is used in certain heart rate and blood pressure~     conditions. This medication, as a side effect, is known to also cause changes in the junction~     between a nerve and muscle. The changes caused at the nerve muscle junction by pyridostigmine~     could alter the effect of muscle relaxants (a medication used during surgery and anesthesia).~     The investigators are conducting this study to see whether patients taking pyridostigmine are~     more or less sensitive to rocuronium (a muscle relaxing medication used during surgery).~   "
107713|NCT02157532|"~     Stroke constitutes the primary cause of acquired disability in adults and the second cause of~     dementia following Alzheimer disease. It has been shown that patients with a moderate to~     severe clinical score have occlusion of brain large vessels, resulting in a worse clinical~     outcome. Many studies have demonstrated that early recanalization after IV rtPA is more~     restricted, the larger and more proximal the artery. Several systems for mechanical~     intracranial arterial thrombectomy of large trunks have recently been proposed and are now~     available. Potential advantages of these mechanical systems on chemical thrombolysis are~     speed (a few minutes versus 1 hour) and absence of thrombolytic injection.~      The objective of the EASI trial is thus to:~        -  To validate intra-arterial thrombectomy use during the acute phase of cerebral stroke in~          patients treated with IV thrombolysis or in patients for whom thrombolysis is~          contra-indicated.~        -  To determine whether a combined approach, standard treatment plus thrombectomy, is~          superior to standard treatment alone within 5 h of the appearance of symptoms, in~          patients with occlusion of proximal cerebral arteries following moderate to severe~          stroke (NIHSS larger than or equal to 8), evaluated at 3 months.~      The design is a randomized, controlled multicentric trial, with a parallel comparison between~     standard and combined (standard plus thrombectomy) treatment.~      480 patients fulfilling eligibility criteria will be sufficient to demonstrate the primary~     hypothesis of a 15% difference in number of subjects with a favorable mRS (less than or equal~     to 2) at 3 months, with the assumption of a 25% efficacy for IV thrombolytic treatment at 3~     months.~      IV thrombolysis is carried out according to standard practice. Mechanical thrombectomy is~     carried out with already approved devices, according to the manufacturer's instructions,~     following a diagnostic cerebral angiography.~      The primary efficacy endpoint is clinical: favorable mRS (less than or equal to 2) at 3~     months.~      The primary safety endpoint is rate of death at 3 months and rate of symptomatic hemorrhage~     at 24 hours.~      If the primary hypothesis is validated, expected benefits of this study is a higher rate of~     autonomy for stroke patients with all the attendant consequences: reduction in hospital~     stays, and a faster return to the activities of daily life.~   "
107723|NCT02157402|"~     Our hypothesis is that healthy lifestyles improvement by an intervention designed according 8~     social marketing Benchmark criteria, can reduce overweight or obesity implemented by~     adolescents on their colleges.~      The general aim of EYTO program is to improve health and well-being among adolescents who~     live in low socioeconomically communities, through an intervention study designed by selected~     adolescents with the inclusion of social marketing Benchmark criteria.~   "
107714|NCT02157519|"~     Many people treated for cancer receive oral chemotherapy medications for their illness. This~     means that much of their cancer care occurs at home, away from a traditional oncology care~     setting. The purpose of this study is to explore how a Smartphone mobile application (mobile~     app) can help improve the cancer treatment process in people who are prescribed oral~     chemotherapy medication. The investigators will explore how well the mobile app helps~     patients stay connected with their oncology care team, take their oral medications as~     prescribed, and manage their cancer-related symptoms from home. This study will be done in~     two phases: 1) a pilot phase to assess the feasibility of a mobile application intervention,~     and 2) a randomized-controlled trial to test the intervention.~   "
107715|NCT02157506|"~     A randomized, double-blinded, placebo-controlled study of continuous 6-hour IV infusions of~     CXL-1427 in hospitalized patients with systolic heart failure.~   "
107716|NCT02157493|"~     This study will use a randomized controlled design to evaluate whether a youth~     entrepreneurship/life-skills intervention for reservation-based American Indian adolescents~     (ages 13-15) improves psychosocial, behavioral health, educational, and economic outcomes~     from baseline for up to 3 years follow-up as compared to a recreational sports league control~     condition.~   "
107717|NCT02157480|"~     Prevalence of type 2 diabetes (T2D) is increasing worldwide. Lifestyle remains the~     cornerstone treatment for patients with T2D who are often overweight and sedentary.~      Physical activity improves glucose metabolism of patients with T2D : increased glucose~     utilization during acute muscle activity and improved insulin sensitivity after regular~     training. The molecular mechanism underlying the effects of exercise on glucose metabolism~     involves the glucose transporter GLUT-4 which is regulated by physical activity.~      Several studies and meta-analysis have showed that physical activity reduces HbA1c by 0.6% on~     average. In addition, other data suggest a decrease in cardiovascular morbidity and mortality~     through physical activity.~      Recent recommendations for T2D management call for the practice of a structured type of~     endurance 150 minutes per week and muscle building 2 times per week. However, implementation~     of these recommendations is low, even when integrated into a therapeutic education program.~     Adherence is often transient and / or partial. In addition, many T2D subjects are unable to~     initiate a physical activity because of disabling complications or comorbidities or because~     of a major cardiorespiratory deconditioning.~      Neuro-myo electrical stimulation (NMES) is a physical treatment routinely used in functional~     rehabilitation to improve muscle strength and volume. The metabolic effect of NMES has been~     little studied. A pilot study conducted by our team on a population of 18 subjects with T2D~     showed that a week of daily NMES sessions significantly improved insulin sensitivity of about~     25% and up to 50 % for good responders. This result contrasted with the low induced energy~     expenditure by each 20-minute session of bi-quadricipital NMES, suggesting the possibility of~     a humoral or neural mechanism associated with NMES.~      To complete this work, we plan a randomized cross-over trial with 3 periods (6 weeks without~     NMES (control), 6 weeks with 3 sessions of NMES per week and 6 weeks with 5 sessions of NMES~     per week) to assess the glucose profile of sedentary T2D subjects during these different~     periods. We hypothesize that the bi-quadricipital NMES could improve glycemic control in T2D~     subjects and thus represent an alternative to traditional physical activity.~   "
107718|NCT02157467|"~     The purpose of this study is to assess the effect of BMS-955176 on the pharmacokinetics of~     coadministered oral contraceptives.~   "
107719|NCT02157454|"~     Being diagnosed with cancer confronts patients with a severe disease and they need to learn~     to deal with a range of new challenges. In order to support patients in the coping process,~     the website www.krankheitserfahrungen.de provides patients free, reliable information about~     health issues by sharing peoples' real-life experiences. In our project, the investigators~     developed a new module on the website for patients with colorectal cancer.~      The objective of our study is to evaluate if access to the new colorectal cancer module on~     the website www.krankheitserfahrungen.de increases patient's competence.~      The investigators will conduct a two-arm randomized controlled trial. Patients affected by~     colorectal cancer will be randomized into an intervention and a control group: the~     intervention group will have access for two weeks to the website www.krankheitserfahrungen.de~     (colorectal cancer module) with cancer patients´ experiences. Patients in the control group~     will not receive any intervention but will have access to the website for two weeks after~     completing the study.~      Patient competence is measured by the self-efficacy component of the German short form of the~     Cancer Behavior Inventory via an online questionnaire at baseline and after two weeks. A~     second follow-up assessment will be implemented six weeks after baseline.~   "
107720|NCT02157441|"~     Objective: To assess the efficacy of lower uterine compression sutures (involved bilateral~     uterine artery ligation and compression of the lower uterine segment at the same time with~     one circular stitch) as a conservative treatment for the treatment of postpartum hemorrhage~     in women with placenta previa complete centralis. Method: This prospective study of 50 women~     with postpartum hemorrhage following removal of placenta previa complete centralis during~     elective cesarean section. All 50 patients will have lower uterine compression sutures~     (involving bilateral uterine artery ligation and compression of the lower uterine segment at~     the same time with one circular stitch). All patients will be followed postpartum for~     evaluation of uterine cavity and menstrual cycles~   "
107721|NCT02157428|"~     Background and objectives: The inhalational anesthetic isoflurane is widely used in general~     anesthetics. Its mechanism of action involves interaction with the receptor of gamma-amino~     butyric acid (GABA), which is also the binding site for benzodiazepines. Flumazenil,~     benzodiazepine antagonist, reverses the effects of these drugs in GABA receptors and could~     therefore also reverse the effect of isoflurane. In anesthesia practice, extubation and early~     anesthetic recovery reduce morbidity and incidence of complications. The objective of this~     trial is to determine whether the use of flumazenil may contribute to faster recovery from~     anesthesia. Methods: 40 patients scheduled to undergo general anesthesia with isoflurane were~     enrolled in this prospective, double-blind, randomized trial. Patients were randomized to~     receive, at the end of anesthesia, flumazenil or placebo as allocated into two groups. The~     anesthetic technique was standardized. The groups were compared concerning values of Cerebral~     State Index (CSI), heart rate, blood pressure and oxygen saturation from the application of~     flumazenil or placebo until 30 minutes after injection. Data regarding time to extubation,~     time to reach ten points in the Aldrete-Kroulic score (AK = 10) and Vigilance score (VS = 10)~     was also collected. ANOVA test was applied to analyze the results, considering p <0.05.~   "
107722|NCT02157415|"~     It is the first clinical study aimed at assessing the safety and tolerability of UT-P as~     routine rinsing and bacterial decolonization solution device for urinary catheters. The study~     will be conducted in hospitalized adult patients who had an urethral or suprapubic catheter~     in place for longer than two consecutive weeks and who are able to provide written consent.~      This is an open-label prospective observational cohort study. No comparative control group is~     planned as no other preventing infection solution is commercially available at this time.~   "
107724|NCT02157389|"~     Placebo and nocebo responses have mainly been studied in healthy humans for pharmacological~     rather than psychological interventions. Moreover, only few studies examined patients or~     tested how previous experience and attitudes affect placebo and nocebo responses. On the~     psychological level expectancy and classical conditioning have been identified as two primary~     mechanisms. Both seem to be important with classical conditioning potentially having more~     long-term effects and expectancy being more important in nocebo effects. There is some~     initial evidence from the investigators own research that patients may be more prone to these~     effects and the investigators have also shown that placebo effects may last up to several~     years after treatment. The investigators therefore examine previous attitudes to~     pharmacological interventions for chronic pain in patients with chronic back pain and~     subdivide them into groups with high of low belief in the respective treatment modality. The~     investigators then apply a pharmacological placebo and study the interaction between the~     prevailing attitude (implicit and explicit) and the placebo effect with respect to pain~     perception but also to neurobiological mechanisms using functional magnetic resonance~     imaging. In addition to expectancy, conditioning of placebo will be examined and the~     long-term effects of the intervention will be determined.~   "
107725|NCT02157376|"~     The efficacy of esomeprazole will be compared versus cimetidine (a drug that previously~     demonstrated prevention of bleeding events) during treatment period in proportion of patients~     for the prevention of upper GI bleeding.~   "
107726|NCT02157363|"~     Open thoracoabdominal esophagectomy (TAE) is the standard curative treatment modality for~     resectable esophageal cancer. TAE can be achieved by positioning the patient in the supine~     position for the abdominal part and in a left-lateral decubitus (LLD) position for the~     thoracic part, or by performing both parts in a left-screwed supine position (LSS). Aim of~     the present study is to compare peri- and postoperative outcome variables after TAE for~     esophageal cancer in the two positions.~      POETRI is designed as a single-center, randomized controlled trial with two parallel arms~     including patients with resectable esophageal cancer and type I cancers of the~     esophagogastric junction (AEG I). Exclusion criteria are inability to tolerate surgery or~     both types of positioning, inability to perform an intrathoracic anastomosis, non-malignant~     pathologies. The primary endpoint is operating time. Secondary endpoints are morbidity, lymph~     node yield, pulmonary function, pain control and wound healing assessed during a follow-up of~     3 months.~      POETRI is a single-center, randomized controlled trial to evaluate different positioning and~     thoracic access during radical open thoracoabdominal esophagectomy for patients with~     resectable esophageal cancer.~   "
107727|NCT02157350|"~     The purpose of this study is to determine the threshold level of proliferative diabetic~     retinopathy progression and regression after standard panretinal photocoagulation. Predictors~     of progression and regression will be identified which will include retinal vessel geometry~     (caliber, fractals and tortuosity), retinal vessel oxygen saturation and retinal areas of~     non-perfusion.~   "
107728|NCT02157337|"~     Acute kidney injury(AKI) is a common and severe complication after the cardiac surgery.~     Postoperative AKI increases the in-hospital stay, intensive care unit(ICU) stay and~     postoperative mortality. Aortic surgery is the most risky surgery that causes the~     postoperative AKI, and the incidence of AKI after aortic surgery is about 50%.~      Statin is a 3-hydroxy-3-methyl-glutaryl co-enzyme A (HMG CoA) reductase inhibitors and is~     used primarily to lower the level of plasma cholesterol. Apart from the antilipid effect,~     statin has pleiotropic effects include anti-inflammation, decrease of oxidative stress,~     recovery of endothelial cell injury and stabilization of thrombus.~      The pathology of AKI after aortic surgery include not only hypoperfusion of renal blood flow~     but also thromboembolism, inflammatory reaction after use of cardiopulmonary bypass(CPB) and~     oxidative stress. Therefore, the incidence of AKI after aortic surgery can be expected to~     decrease after the perioperative use of statin because of the pleiotropic effects of it. The~     aim of this study is to examine the association between preoperative statin treatment and the~     incidence of postoperative acute kidney injury(AKI) in patients undergoing aortic surgery~   "
107729|NCT02157324|"~     This study is evaluating the safety and efficacy of the combined use of acalabrutinib and~     ACP-319, for the treatment of chronic lymphocytic leukemia (CLL)~   "
107730|NCT02157311|"~     Evaluate after 48 weeks, the capacity of a weekly strategy of 4 consecutive days on treatment~     followed by 3 days off treatment, in HIV-1 treated patients with undetectable viral load for~     at least 12 months and continuous antiretroviral regimen unchanged for at least 4 months, to~     maintain a therapeutic success defined by the absence of virological failure (2 consecutive~     viral loads > 50 cp/mL) and the absence of interruption of therapeutic strategy (interruption~     or change of the  4 days on / 3 days off  strategy for a time longer than 30 consecutive~     days).~   "
107731|NCT02157298|"~     Japanese male and female patients with Type 2 Diabetes and aged ≥ 20 years old, with~     inadequate glycemic control on insulin defined as Haemoglobin A1c ≥ 7.2% and < 11% will be~     enrolled into the wash-out phase or directly into the lead-in phase depending on whether the~     patient has been receiving an Oral antidiabetic drug (including Glucagon-Like Peptide-1~     agonists and excluding Thiazolidinedions) other than a Dipeptidyl Peptidase-4 inhibitor as~     part of the baseline treatment. Additional treatment with a concomitant Dipeptidyl~     Peptidase-4 inhibitor is allowed. And around 180 eligible patients in total will be~     randomized into the study with a 2:1 randomization scheme (i.e.120 patients into the~     dapagliflozin treatment group and 60 patients into the placebo treatment group. All subjects~     who completed a 16 weeks double-blind treatment period will shift to a 36 weeks open~     extension treatment period.~   "
107732|NCT02157285|"~     This is a prospective, randomized-controlled trial in which subjects will be randomized to~     receive either routine contraceptive counseling or peer mentoring plus routine contraceptive~     counseling.~   "
107766|NCT02156843|"~     The purpose of this study is to evaluate the safety and efficacy of oral Pyridorin 300 mg BID~     in reducing the rate of progression of nephropathy due to type 2 diabetes mellitus.~   "
107767|NCT02156830|"~     The project consists of qualitative interviews with all the members of the obesity team~     (endocrinologist, bariatric surgeon, dietician, psychologist,..) in different Flemish~     hospitals. These interviews have the aim to gain insight into the current practice about~     counseling patients with bariatric surgery, with a focus on medication counseling. This will~     make it possible to assess the strengths and weaknesses in the current practice of obese~     patients who will undergo and have undergone bariatric surgery.~   "
107733|NCT02157272|"~     Primary Study Objective(s) The primary objective is to demonstrate the non-inferiority of~     Rivaroxaban 20 mg (or 15mgqd in case of moderate renal insufficiency) versus warfarin (INR~     2.0-3.0) with respect to the occurrence of the cumulative end point of incident acute~     thrombosis (arterial or venous) confirmed by appropriate imaging studies, major bleedings,~     and death in triple aPL-positive APS patients.~      Study Design A multicentre, interventional, prospective, parallel, randomised, controlled,~     open-label, Rivaroxaban 20 mg qd (or 15mg qd in patients with moderate renal insufficiency)~     vs warfarin (INR target 2.5), non-inferiority study, in 535 triple aPL-positive APS patients~     in approximately 40 Internal Medicine and Thrombosis centres. Each local Institutional Review~     Board will approve the study.~      Study Population Patients of both sexes, of age 18-75, affected by anti-phospholipid~     syndrome, with a high probability of recurrences as defined by triple aPL-positivity, are~     eligible for this study.~      Primary Outcome variables The primary cumulative outcome measure will be incident acute~     thrombosis (arterial or venous) confirmed by appropriate imaging studies, major bleeding, or~     death.~      Secondary Outcome variables Separate evaluation of arterial and venous thrombosis and~     all-cause death.~      04.27.2015: An amendment has been made. Enrollment permitted till 75 years of age.~   "
107734|NCT02157259|"~     This is an observational study to identify the etiology, management, and outcome of~     community-acquired sepsis and severe sepsis in children and adults in Southeast Asia. The~     study will take place in Thailand, Vietnam, and Indonesia, the partner countries of SEAICRN.~     Potential study patients will be any patients (both children and adults) who are presented at~     the hospital with community-acquired sepsis or severe sepsis and require hospitalization.~   "
107735|NCT02157246|"~     A low level of oxygen in cancer cells makes them less likely to respond to chemotherapy and~     radiotherapy treatments. There is interest in using new drugs that improve the level of~     oxygen in tumours. Another approach would be to increase the radiotherapy dose to tumours~     with low oxygen levels.~      Before we can do this for patients with rectal cancer, we need to develop a reliable way of~     identifying areas of low oxygen within the rectal tumour. This will make us able to tell~     which patients may be suitable for such a change in their treatment.~      Traditionally, the level of oxygen in tumours is measured by inserting a needle into the~     tumour and measuring it directly. This is not possible in rectal cancer. This study has been~     designed to identify the best alternative method. We would like to do a blood test, take~     samples of cancer tissue and some detailed scans (18F-fluoromisonidazole (F-MISO) positron~     emission tomography, perfusion computed tomography, functional magnetic resonance imaging).~     The results of these tests will be compared to decide which gives us the most comprehensive~     and reliable information.~      Patients in Group A go straight to surgery. By looking for markers of low oxygen levels on~     the tumour that has been removed, we will be able to find out which of the study tests~     performed before the tumour was removed is the best. By repeating the scans we will be able~     to see how reliable they are and how much they change on a day to day basis. We think that~     tumours that still have low levels of oxygen after 8 to 10 doses of radiotherapy are the~     least likely to respond to treatment.~      Group B will have scans before radiotherapy treatment and after 8 to 10 doses of radiotherapy~     to see if we can identify the patients that have persistent low levels of oxygen.~   "
107736|NCT02157233|"~     The potential of physical activity and other non-medicinal methods for the care and~     prevention of metabolic and cardiovascular disorders has been insufficiently used. There is a~     potential influence of environmental heat in energetic balance regulation. However, the~     existing knowledge is insufficient to optimize physical activity programs based on the impact~     of exercise on energy intake regulation in hot climates. The aim of the present study is to~     define the major physiological determinants of short-term food intake regulation in young~     active and healthy men, when exposed to different levels of metabolic activity and~     environmental temperatures. We will thus explore the biological mechanisms related to~     post-exercise relative energy intake. Post-rest and post-exercise energetic compensation will~     be analysed in these different environmental conditions, with a special focus on the effect~     of the birth weight. This study should open interesting ways to define adequate nutritional~     and exercising programs in hot environments.~   "
107737|NCT02157220|"~     This is a randomised control trial comparing two different prosthetic designs used in total~     knee arthroplasty. Participants were randomised to receive either of the two prostheses and~     then were followed up of a period of 7 years, looking at pain, range of motion and impact on~     quality of life. The literature and joint registry of Australia shows that one of the~     prosthesis may be inferior to the other. Our research team hypothesised that this was not the~     case and that previous elicited differences were related to other factors.~   "
107738|NCT02157207|"~     This research is,being done to better understand how antioxidants (vitamins C, E and Alpha~     Lipoic Acid) af,f,ect the heart,and arteries. For this study, we will obtain blood samples to~     measure oxidative stress markers (substances in the blood that are linked to oxidative~     stress), cholesterol, insulin and blood glucose (sugar), as well as measure how well the~     heart and arteries are working following supplementation with the antioxidants.~      Our central hypothesis is that acute antioxidant supplementation will improve arterial~     function at rest and during exercise in African Americans without an impact of age, whereas~     aging will modify these effects in Caucasians.~   "
107739|NCT02157194|"~     EBUS-TBNA specimen are used for lung cancer diagnosing and staging, as well for molecular~     analysis. The purpose of this study is to evaluate if samples from on lymph node site can be~     divided for diagnosis and molecular analysis.~   "
107740|NCT02157181|"~     The study will test the effectiveness (rate of complete remissions, total remission rate and~     duration of remission) and toxicity of the combined immuno/chemotherapy with subcutaneous~     cladribine (LITAK®) plus anti-CD20* antibody rituximab in patients requiring treatment for~     relapsed hairy cell leukaemia or hairy cell leukaemia variant independent of any previous~     therapy.~      CD20* = cluster of differentiation antigen 20~   "
107741|NCT02157168|"~     The investigators propose to test a community-developed and targeted intervention that~     employs community health workers (CHWs) as aides to newly Medicaid-insured women. These women~     face the challenges of engaging with their healthcare and health and of making highly~     personal and socioculturally embedded decisions about reproductive health-related preventive~     services (e.g., contraception, STI and cancer screening).~   "
107742|NCT02157155|"~     Hypothesis~        1. To define whether stimulation of ATGL and suppression of G0/G1 switch gene occur in the~          initial phases of diabetic ketoacidosis and thus can be identified as the primary~          mechanisms behind this life threatening condition.~        2. Make a human model for studying ketoacidosis.~      The investigators plan to reduce in their regular insulin over night. In the morning we~     administer endotoxin, which together with a relative lack of insulin will initiate~     ketogenesis - a state of ketoacidosis. On another occasion strict glycemic control is imposed~     by means of intravenous insulin. The testing is done two separate days with at least 3 weeks~     in between and patients are admitted to hospital the evening before the day of testing. The~     investigators use isotopic tracers to determine metabolic fluxes and analyse fat (ATGL, G0/G1~     switch gene) and muscle biopsies.~   "
107743|NCT02157142|"~     The purpose of this study is to evaluate the safety and performance of the HLT System in~     patients with severe aortic stenosis who present at High Risk for aortic valve replacement~     surgery.~   "
107744|NCT02157129|"~     Patients after tracheostomy represent a substantial part in the ear nose throat clinic.~     Long-term intubated patients in intensive care units also profit from tracheostomy due to an~     improved respiratory toilet. However, after tracheostomy patients demonstrate shunt~     ventilation bypassing the sinonasal and pharyngeal system. The physiological moistening,~     cleaning and warming of the breathing air fail resulting in a respiratory inflammation.~     Beside a variety of supportive medical devices no general recommendation exists at present.~     Recently, we demonstrated the beneficial application of local phospholipids in Sjoegren's~     syndrome and antineutrophil cytoplasmatic antibody associated sinonasal vasculitis.~      In the current monocentric, two-armed, double-blinded, randomized parallel group study we~     would like to evaluate the beneficial application of LipoAerosol© when compared with standard~     physiologic saline inhalation. LipoAerosol© is a licensed, tradable medical device and will~     be applied as part of its intended use. Liposomal inhalation solution provides moistening,~     cleaning and warming of the upper and lower respiratory tract and supports the natural~     moistening film in airway irritations and diseases.~      Blood parameter (leucocytes and c reactive protein) and tracheobronchial secretion~     (Lymphocyte subpopulation, c reactive protein, lactate dehydrogenase, granulocyte macrophage~     colony stimulating factor, interferon γ, interleukins 10, 12 (p70), 13, 1β, 2, 4, 5, 6, 7, 8,~     tumor necrosis factor α) will be collected 1, 3, and 10 days after tracheostomy. In addition,~     medical examination records the number of suction maneuver (0 points: none; 1 point: 5-10x/d;~     2 points: 10-20x/d; 3 points: >20x/d), flexible-optical assessment of tracheo-bronchial~     redness (0 point: none; 1 point: peristomal; 2 points: tracheal; 3 points: tracheo-bronchial)~     and flexible-optical assessment of mucous congestion (0 point: none; 1 point: fluent; 2~     points: tenacious; 3 points: barky).~      Subjective estimation of the respiratory impairment will be analyzed via visual analogue~     scale (Subjective overall impairment, coughing frequency, breathlessness, mucous congestion,~     color of sputum, consistency of sputum). The study is designed without any additional~     invasive or incriminating clinical examination.~      Aim of the study is to maintain the functional integrity of the tracheo-bronchial system~     after tracheostomy using LipoAerosol© resulting in a general therapeutic recommendation.~   "
107745|NCT02157116|"~     Dose-dense chemotherapy is a chemotherapy treatment plan in which drugs are given with less~     time between treatments than in standard chemotherapy. The two chemotherapy drugs used in~     this study, docetaxel and cisplatin, are approved for the treatment of lung cancer when given~     every 21 days. This study is exploring the response to chemotherapy when these drugs are~     given every 14 days. In addition, genetic tests will be performed on pre-treatment specimens~     to identify signatures that may predict chemotherapy sensitivity or resistance.~   "
107746|NCT02157103|"~     STUDY BACKGROUND:~      This research will involve patients with glioblastoma. The drug bevacizumab (Avastin) is FDA~     approved for the treatment of glioblastoma that gets worse after standard therapy. For~     glioblastoma, bevacizumab is given by vein every 14 days. The purpose of this study is to see~     if bevacizumab works as well when it is given as a daily subcutaneous shot as it does when~     given intravenously. A subcutaneous shot is like an insulin shot or a heparin shot. The dose~     of bevacizumab given on this study is in total slightly lower than the FDA approved dose for~     glioblastoma.~      STUDY DESCRIPTION:~      About 10 people will take part in the study. Participants or caregivers will be educated on~     injection and given prefilled syringes to take home. Participants or caregivers will~     administer bevacizumab subcutaneously each day. The bevacizumab will be stored in the~     refrigerator.~      Follow up visits will be weekly for the first 3 weeks, then every 3 weeks. After 18 weeks,~     the follow up interval can be increased to every 6 weeks at the treating physician's~     discretion.~      Participants can keep taking the bevacizumab until:~        -  Tests show that they are not benefiting from it,~        -  The participant has a bad side effect related to study treatment,~        -  The participant can no longer comply with study requirements, or~        -  The participant or doctor feels it is no longer in the participant's best interest.~   "
107747|NCT02157090|"~     Recent clinical studies showed, that a hydrocolloid patch is effective, well tolerated and~     comparable with aciclovir cream 5 % for the treatment of HSL lesions, while affording~     additional benefits of wound protection, discretion and relief of social embarrassment. The~     aim of the actual study was the clinical assessment of the effectiveness and safety of~     Hansaplast® SOS Herpes Patch (HPHP) in comparison to Compeed® Herpes Vesicle Patch (CHP) in~     treating HSL. Both products are CE-certificated and are available at the market for medical~     devices.~   "
107748|NCT02157077|"~     The purpose of the current study is to evaluate the ability of Eylea to induce a regression~     of PED height on patients previously extensively treated by Lucentis.~      The regimen proposed for this study is the 3 monthly injection followed by a 6 weeks interval~     injection until week 26.~   "
107749|NCT02157064|"~     The purpose of this study is to determine the impact that treatment with a cellular~     concentrate derived from an individual's own fat, known as the stromal vascular fraction~     (SVF), has on the quality of life of people with multiple sclerosis (MS). SVF contains~     components with regenerative properties, including stem cells that may be capable of~     ameliorating specific disease conditions. This study is designed to evaluate quality of life~     changes in individuals with MS for up to 12 months following SVF treatment.~   "
107750|NCT02157051|"~     This phase I trial studies the side effects and best dose of multiantigen deoxyribonucleic~     acid (DNA) plasmid-based vaccine in treating patients with human epidermal growth factor~     receptor 2 (HER2)-negative stage III-IV breast cancer. Multiantigen DNA plasmid-based vaccine~     may target immunogenic proteins expressed in breast cancer stem cells which are the component~     of breast cancer that is resistant to chemotherapy and has the ability to spread. Vaccines~     made from DNA may help the body build an effective immune response to kill tumor cells.~   "
107751|NCT02157038|"~     This study is investigating whether changes in the shape and size of bodily muscles and~     spinal cord anatomy can influence recovery rates following a motor vehicle collision (MVC).~     The objective is to demonstrate that the presence of muscle and spinal cord degeneration and~     associated muscle weakness is the consequence of a mild MVC-related injury involving the~     cervical spinal cord.~   "
107752|NCT02157025|"~     The majority of young children do not think that visual field (VF) testing of peripheral~     vision is similar to a game; therefore, it is not surprising that they have difficulty~     maintaining attention during VF testing and thus the test reliability suffers as a~     consequence. Poor VF reliability has been a longstanding, major issue since it leads to an~     increased number of tests and/or longer duration of time needed to determine when there are~     true vision losses. Providers are less likely to obtain VF tests in children since the~     results are of doubtful value and challenging to interpret when they are inconsistent.~     Effectively this means that children with untreated, slowly progressive eye diseases may go~     undiagnosed and incur greater visual losses. The investigators aim to create a prototype~     device that the investigators hypothesize will make VF testing more engaging for young~     children, thus increasing their attention and consistency of their responses to the test~     stimuli, which in turn should improve VF reliability. The components include a microdisplay~     video screen (1.5 diameter) as the fixation target (instead of the standard LED light)~     displaying video clips of popular cartoon characters, and audio clips of impersonated cartoon~     character voices presented by the test operator to provide instructional feedback based on~     the child's performance during testing. Improved VF reliability from the investigators~     intervention would translate to improved diagnosis and care for young childrens' peripheral~     vision loss through widespread implementation of the investigators innovative, affordable and~     readily adoptable system at eye care providers' offices.~   "
107753|NCT02157012|"~     To examine the safety and effectiveness after Xeljanz treatment in rheumatoid arthritis~     patients~   "
107754|NCT02156999|"~     To examine the changes of bone mineral density and bone turnover markers after Bonviva~     treatment in osteoporotic patients~   "
107755|NCT02156986|"~     The main objective of the study is to conduct a pilot study on the characterization of the~     mastication abilities of infants and toddlers using different commercial cereal based~     products in order to gain knowledge and be able to plan future studies.~   "
107756|NCT02156973|"~     Coming for a cardiac test can be a daunting experience. Despite providing written information~     sheets for patients, experience in the scanner demonstrates that many patients are~     ill-prepared when they attend for cardiac computed tomography (CT). Heart rate control is~     essential for high image quality, as this prolongs cardiac diastole (during which imaging~     occurs) and results in less motion blur, but this may be challenging to achieve in the~     context of an anxious patient. In such situations, additional radiation exposure is required~     to optimise the chances of diagnostic images. Thus, poor patient selection and preparation~     has been shown to increase the radiation burden to the patient, as well as to increase the~     rate of non-diagnostic scans, leading to patients needing additional, alternative testing.~     This can be distressing for patients and increases downstream costs for the hospital. Poor~     patient awareness is also known to increase the anxiety of attending for a test.~      Improved patient information and understanding has been shown to improve outcomes in a wide~     variety of hospital settings. Evidence from cardiac catheterisation angiography suggests that~     the use of alternative information formats can reduce patient anxiety and improve patient~     satisfaction, as well as improving their understanding of the technical requirements of a~     test. The latter may contribute to improved preparation - for example, patients who do not~     understand the requirements for cardiac CT, particularly the need for a slow heart rate, will~     often consume caffeine, stop their heart-slowing drugs, or even run or cycle to their~     appointment.~      We have agreed a collaboration with Plymouth University to create patient information videos~     for CT. These will utilise the expertise of media students (their department also runs a~     commercial arm, due to the quality of their output), in conjunction with the clinical~     requirements and patient participation groups, to create an accessible, engaging and~     informative film. We wish to evaluate the impact of this method of conveying information to~     patients on how well they are prepared to undergo testing.~      If this concept is successful, it may be of use to patients undergoing a huge range of tests~     or treatments across specialities. We therefore need to demonstrate the efficacy (or~     otherwise) of such an intervention.~   "
107757|NCT02156960|"~     It has not been well known about the changes of bone metabolic markers, bone mineral density~     and other bone-related markers after teriparatide and/or denosumab treatment in Japanese~     osteoporotic patients.~   "
107758|NCT02156947|"~     In theory, increased vascularity of GB wall could be associated with intraoperative findings,~     such as, GB wall inflammation and accompanying adhesions. There are not enough reports in the~     literature describing the correlation between GB wall vascularity and operative findings~     according to adhesion scoring scale. In this prospective clinical study, we aimed to~     highlight the correlation between preoperative power Doppler sonography detected GB wall~     vascularity and intraoperative findings - postoperative outcomes of chronic and acute~     cholecystitis patients.~   "
107759|NCT02156934|"~     This study was designed to provide confirmation of efficacy of muscle derived stem cells~     (MDCs) for the treatment of SUI in women.~   "
107760|NCT02156921|"~     This study aims to investigate the cost-effectiveness of app-based self-directed ultrasound~     training compared to self-directed training with written handouts on subsequent performance~     on simulated patient cases and theoretical cases.~   "
107761|NCT02156908|"~     The investigators will first test, in a pilot study, the effects of 3 days of D-serine (DSR)~     on auditory plasticity in a sensory based remediation (SBR) paradigm, and then do a~     small-scale double-blind study of DSR + SBR on auditory emotion recognition.~   "
107762|NCT02156895|"~     The objective of this study is to monitor the usage of INLYTA® in real practice, including~     the adverse events associated with INLYTA®.~   "
107763|NCT02156882|"~     In this longitudinal study with a follow up time of at least 6 months, up to 300 tuberculosis~     (TB) patients or TB suspects will be screened for TB using the Xpert MTB/RIF assay along with~     standard smear microscopy after Ziehl-Neelsen staining at the TB health clinic located at~     Mavalane health center. Confirmed TB cases will be followed up during TB therapy until month~     six after treatment initiation in order to obtain clinical and microbiological data on~     treatment including treatment response. Apart from relevant research questions in the field~     of TB diagnostics and treatment, the main objective of this study will be the development of~     a clinical TB research site, including capacity development in clinical and laboratory based~     TB research methods, in Mavalane, Maputo.~   "
107764|NCT02156869|"~     Although the number of recommendations against systematic screening of prostate cancer, 70%~     of patients still request testing because they overestimate the benefits and are unaware of~     the limitations.~      The investigators aim is to assess the impact of a short printed decision aid presenting~     benefits and limits of screening, on patients' intent to undergo prostate cancer screening.~   "
107765|NCT02156856|"~     Compromised peripheral tissue oxygenation during surgery may lead to worse patient outcome,~     mainly due to post-operative infections or heart failure. Insufficient stroke volume and/or~     cardiac output due to hypovolemia or cardiac defects play a central role in causing poor~     peripheral tissue oxygenation. In order to assess stroke volume, there are numerous invasive~     and non-invasive methods available. Up to the present date it is unknown, if these methods~     may by used interchangeably in patients with severe cardiac defects like aortic stenosis.~   "
107768|NCT02156817|"~     Moderate and late preterm infants contribute to significant neonatal intensive care unit~     health care resource utilization because of their sheer numbers. Determinants of the length~     of hospitalization (LOH) in this population are understudied. Gestational age (GA) is used~     most commonly as a predictor for LOH but there are many limitations including inaccurate~     dating and morbidities of prematurity which at least partly related to neurophysiological~     immaturity. The latter can be assessed by amplitude integrated electroencephalogram (aEEG, a~     simplified 5 lead EEG), and possibly by heart rate variability (HRV) and respiratory~     variability (RV). All 3 are non-invasive tests that can be done at the bedside. Our study~     hypothesis is to determine if neurophysiologic maturation as assessed by aEEG, HRV and RV~     within 24-96 hours following birth improves the correlation between gestational age and~     length of hospitalization compared to gestational age alone.~   "
107769|NCT02156804|"~     The purpose of this study is to determine the rate and frequency of high-grade (CTCAE v4.0~     Grade 3 or higher), treatment-related, select adverse events in subjects with histologically~     confirmed stage III (unresectable) or stage IV melanoma and progression post prior treatment~     containing an anti-Cytotoxic T Lymphocyte Antigen (CTLA-4) monoclonal antibody, treated with~     Nivolumab (BMS-936558) at a dose of 3 mg/kg every two weeks.~   "
107770|NCT02156791|"~     gpASIT+TM product is based on highly purified allergen fragments obtained from grass pollen.~     The purpose of this clinical trial is to confirm the safety, clinical tolerability and~     immunogenicity of increasing doses of gpASIT+TM administered subcutaneously to patients with~     grass pollen-induced allergic rhinoconjunctivitis, and to determine the maximal tolerated~     dose of gpASIT+TM .~   "
107771|NCT02156778|"~     Patients after ischemic stroke are at high risk of recurrent cardiovascular events and of~     developing post-stroke complications. There is a substantial gap between risk factor~     management in real life and that recommended by international guidelines. Stroke Card is a~     multifaceted comprehensive post-stroke disease management program to detect and treat~     complications and optimize secondary prevention. The investigators hypothesize that, compared~     to standard care, Stroke Card will lead to an at least 33.3% risk reduction in recurrent~     cardiovascular events and improve health-related quality-of-life.~   "
107772|NCT02156765|"~     Three purpose of this study:~        1. Increase diagnosis rate and formulate the flow of diagnosis and treatment of AF in~          ischemic stroke patients;~        2. Evaluation on specificity and sensitivity of STAF score;~        3. Analyze the pathogenesis of ischemic stroke and risk factors and establish clinical~          database and sample database of ischemic stroke.~   "
107773|NCT02156752|"~     This project is a randomized controlled trial to compare the efficacy of two interventions-~     one based on Acceptance and Commitment Therapy (ACT) and one based on Self-Regulation (SR)-~     and a control group (called weight loss only (WLO)) on 24-month weight loss outcomes. All~     participants will first participate in an initial 4-month standard behavioral weight loss~     program. Participants will be randomized into 1 of 3 groups and receive a 3-part workshop;~     the ACT workshop will teach ACT skills including acceptance and mindfulness techniques~     designed to promote behavior change and health behavior persistence consistent with one's~     core values. The SR program will focus on self-regulation, regular weighing, and modeling~     behavior on successful maintainers. The WLO group will receive a control workshop focused on~     cooking demonstrations and general nutrition topics.The primary outcome is weight loss at 24~     months. The secondary outcome is change in psychological flexibility, a critical component of~     ACT interventions and a potential innovative mediating mechanism. Primary Hypothesis: At 24~     months, the ACT group will show significantly greater weight loss as compared to the SR and~     WLO groups.~   "
107774|NCT02156739|"~     The goal of this clinical research study is to learn if using 2 different kinds of contrast~     agents (Eovist [gadoxetate] and Gadovist [gadobutrol]) given at the same time is better than~     using 1 contrast agent alone in learning which liver lesions may be cancerous.~      Contrast agents are used by doctors in order to see MRI images more clearly.~      This is an investigational study. The MRI scan in this study is performed using an~     FDA-approved and commercially available method. Adding gadobutrol as a second contrast agent~     to try to learn which liver lesions may be cancerous is investigational.~      Up to 100 participants will be enrolled in this study. All will take part at MD Anderson.~   "
107775|NCT02156726|"~     FCR (fludarabine, cyclophosphamide, rituximab) combination is currently accepted as the gold~     standard in treatment of younger and physically fit CLL patients. These excellent results,~     however, cannot be generally applied to the whole CLL population. This is because the median~     age at diagnosis of CLL lies between 65 and 72 years and patients older than 65 years in fact~     account up to 50%-75 % of the CLL population. Nevertheless, such population is considerably~     underrepresented in most of the large clinical trials in CLL/SLL. Therefore, it is not clear~     whether elderly/comorbid patients could profit from newer treatment approaches such as purine~     analog combinations or chemoimmunotherapy. Several publications demonstrated unacceptable~     toxicity of full-dose FC/FCR in elderly CLL patients. However, regimens using attenuated~     doses of fludarabine and cyclophosphamide showed promising efficacy and low toxicity.~   "
107776|NCT02156713|"~     Constraint induced movement therapy (CIMT) is an intervention for unilateral cerebral palsy~     (CP). It is currently part of standard of care for children with unilateral CP, but is~     typically done one-on-one and with the child wearing a cast 24 hours a day during the~     duration of treatment. The purpose of this study is to assess the effects of an intensive~     group-based CIMT summer camp in which participants wear a removable cast on upper extremity~     function, occupational performance, and patient-specific goals. The investigators hypothesize~     that upper extremity skills and occupational performance will increase, and that patients~     will reach their individualized goals.~   "
107809|NCT02156284|"~     The objective was to compare the frequency and intensity of symptoms of fear in patients of~     preoperative cardiac surgery who received empathic behaviour from nurse or those who received~     no specific type of empathic behaviour. This is a randomized clinical trial. The sample~     consisted of 44 patients in preoperative of cardiac surgery, who were divided in two groups:~     empathic behaviour by nurses and without specific empathic behaviour. Fear was assessed at~     two time points: before and after the intervention. The instrument used was developed and~     validated, comprising 15 defining characteristics of the nursing diagnosis fear. The~     hypothesis is that the group who received empathic behaviour from nurse will reduce the~     anxiety.~   "
107777|NCT02156700|"~     Shear Wave Elastography (SWE™) is a quantitative elastography method for measuring tissue~     stiffness. The difference in stiffness between benign and malignant tumors has been~     demonstrated by other elastography methods (acoustic radiation force impulse imaging,~     transient elastography and/or magnetic resonance elastography). The investigators~     hypothesized that benign liver tumors are softer than malignant liver tumors measured by~     SWE™, allowing differentiation between the two by tumor stiffness expressed in kilopascal~     (kPa). In this study benign and malignant liver tumors will be evaluated in five groups: 1)~     hemangioma and 2) focal nodular hyperplasia (FNH) representing the most common benign liver~     tumors; 3) metastases and 4) cholangiocarcinoma (CCC), both presenting malignant tumors~     mostly appearing in otherwise healthy liver, and 5) hepatocellular carcinoma (HCC) mostly~     occurring in cirrhotic liver, which can potentially influence elastographic measurements~     therefore querying the appropriateness of comparison between tumors in healthy and cirrhotic~     liver. Enrolled patients will undergo transabdominal ultrasonography and SWE™ examination.~     The tumor stiffness will be measured five times for each tumor. Additionally, surrounding~     liver parenchyma stiffness will be measured. The nature of the liver tumor will be defined~     through a standard diagnostic workup according to current guidelines, including contrast~     enhanced multi-slice CT, MRI and/or cytology/histology, as applicable. In the final analysis~     the mean tumor stiffness and tumor-parenchyma ratio will be calculated for each group as well~     as for benign and malignant tumors separately, and cut-off values for the differentiation of~     various groups will be derived. The clinical value of the method will be appraised based on~     specificity, sensitivity, positive and negative predictive values, and AUC.~   "
107778|NCT02156687|"~     The primary objective of the proposed study is to determine the difference in suturing time~     when using the restorelle Y mesh versus the restorelle dual flat mesh at the time of~     laparoscopic and robotic-assisted laparoscopic sacrocolpopexy.~      Hypothesis: Suturing time when using the restorelle Y mesh will be faster than when using the~     restorelle dual flat mesh at the time of laparoscopic and robotic-assisted laparoscopic~     sacrocolpopexy.~   "
107779|NCT02156674|"~     This is a single center study in which Naglazyme® will be given weekly for two years in~     patients with Maroteaux-Lamy syndrome, also known as mucopolysaccharide VI (MPS VI), who have~     previously been treated with an allogeneic transplant.~   "
107780|NCT02156661|"~     The purpose of this study is to determine whether oxytocin influences emotional processing~     and learning of emotional and social stimuli.~   "
107781|NCT02156648|"~     The purpose of this project is to assess the feasibility of collecting plasma samples for~     cardiac biomarker assessment, and to identify if there is an associations between the~     biomarkers, echocardiographic features and the cardiac PET scan results (in patients~     receiving radiation therapy). This is the first step in a research program that has an~     overall goal of being able to predict early-treatment induced cardiotoxicity in patients with~     breast cancer.~   "
107782|NCT02156635|"~     The purpose of this study is to determine whether active stimulation of the affected~     hemisphere will be more effective than simulated current in treatment of stroke~   "
107783|NCT02156622|"~     The purpose of this study is to adapt depression treatment intervention for HIV patients in~     Cameroon. The PI will validate a depression severity measure, adapt key elements of the~     intervention to the Cameroon context, train nurses and physicians to carry out the~     intervention, and examine preliminary outcomes.~      Participants: Aim 1: Hospital and clinic patients, visitors, health care workers. Aim 2: No~     participants. Aim 3: HIV-infected patients. Procedures (methods): Survey instruments and ARV~     treatment.~   "
107784|NCT02156609|"~     The HeartMate PHP is a catheter-based pump designed to provide partial left heart circulatory~     support. The study will assess the safety and performance of the HeartMate PHP in supporting~     patients who are hemodynamically unstable, or at risk of being hemodynamically unstable,~     while undergoing percutaneous coronary interventions (PCI), such as coronary stent placement.~   "
107785|NCT02156596|"~     The aim of the investigators study was to evaluate the feasibility, efficacy and safety of~     nebulized morphine compared with non-steroidal anti-inflammatory (NSAI)intravenously in the~     management of renal colic.~      Determine the need for systematic outpatient prescription of NSAI.~   "
107786|NCT02156583|"~     This is an observational study evaluating changes in frailty and associated impairments in~     older heart failure patients receiving left ventricular assist device therapy.~   "
107787|NCT02156570|"~     The purpose of the study is to examine whether patients who have acute or early chronic~     hepatitis C virus (HCV) infection can be treated effectively and safely with an~     interferon-sparing regimen that combines a new direct acting antiviral drug (sofosbuvir) with~     one of the standard treatments for chronic hepatitis C (ribavirin). In particular, this study~     will investigate whether treatment of acute or early chronic HCV can be shortened. The study~     will assess efficacy by looking at the proportion of people who clear the virus (have no~     virus detectable in their blood) at the end of treatment, and 1, 3 and 6 months after~     treatment.~      The hypothesis is that short course (6 weeks) dual therapy using sofosbuvir and RBV will~     result in successful virological eradication in the majority (≥80%) of subjects treated for~     recently acquired HCV.~   "
107788|NCT02156557|"~     We are studying new ways to look for abnormal areas/tissues of the colon during a~     colonoscopy. The current scopes used for colonoscopies are very good. But if the area doesn't~     look different to the naked eye, then the scope can't improve on that. We are using special~     stains or dyes and special scopes to see abnormal areas that are hard to see with the naked~     eye. The stain or dye is fluorescent, meaning it glows when special light is used in the~     colonoscopy scope.~      You are being asked to let us spray a peptide with a fluorescent tag onto your colon.~     Peptides are small chains of amino acids (the building blocks that make up proteins) linked~     together. The peptide we use has 7 amino acids attached to a fluorescent tag (FIT C or~     Fluoresceinisothiocyanate). FITC is used by eye doctors to examine your eyes (the yellow eye~     drops).~      We are testing this fluorescent peptide to see if it will stick if there are any abnormal~     areas. If the peptide sticks, it will glow when a special light in the scope is used. In~     this study, we will apply the fluorescent peptide to your colon by using a spray tube that~     fits in the colonoscope.~      This is a phase IB study. This means that although we have applied the peptide to 25 people~     in our first research study, we still need to learn more about fluorescent peptide in~     people. The Food and Drug Administration (FDA) has not approved this agent, but is allowing~     us to test it in this study. The main goal of this study is to see if the peptide glows~     well and if we can take pictures of areas that do glow.~      This is a research study of the peptide and our ability to see it glow or fluoresce. Being~     in this study and applying the peptide won't change how our biopsies are taken or how your~     colonoscopy is done.~   "
107789|NCT02156544|"~     The purpose of this study is to investigate the safety/tolerability and~     pharmacokinetics/pharmacodynamics of CKD-519.~   "
107790|NCT02156531|"~     Research in the last fifteen years suggests that anxious individuals selectively attend~     towards threatening information. Attention modification interventions for internalizing~     adults have been developed to target cognition at this basic level; these programs have~     demonstrated initial efficacy in attention bias and anxiety symptom reduction. To date, there~     have been minimal published studies of attention modification in youths with clinical levels~     of anxiety.~      This study is a large randomized efficacy-effectiveness trial (N = 498) to test the benefit~     of this low-cost, computerized attention modification intervention (Cognitive Bias~     Modification (CBM) computer application) for anxiety disorders and symptomatology in youth~     ages 12 to 17. This trial conducted will compare three intervention arms, all of which~     include underlying treatment as usual (TAU). The investigators directly test the level of~     clinical support (scaffolding) needed to adequately deliver self-administered CBM to~     anxious youth, a finding that will be key to preparing for future deployment-focused trials.~     The investigators will compare an attention control version of the CBM program (Arm 1) to two~     active versions of the CBM intervention that have varying levels of patient clinical support:~     a self-administered CBM program that participants download and install on their home~     computers (Self-Administered CBM-only; Arm 2), and the same CBM program paired with an~     adherence promotion (AP) component delivered via brief telephone calls from study coaches,~     including as needed, brief motivational enhancement and/or technical assistance~     (Self-Administered CBM+AP; Arm 3).~      The investigators expect that youth receiving CBM and CBM+AP will have improvement in anxiety~     symptoms and functioning. The investigators will also complete a cost-effectiveness analysis~     to examine potential costs offset by this intervention.~   "
107791|NCT02156518|"~     The purpose of this study is to determine if the systematic practice of Vocal Function~     Exercises (VFE) improves selected measures of voice production in participants who have~     previously been irradiated for early glottic cancers compared to participants who receive the~     present standard of care, namely, vocal hygiene counseling. It is hypothesized that a~     prescriptive vocal exercise program (VFE) will improve the voice production of individuals~     who have been previously treated for laryngeal cancers when compared to participants who~     receive vocal hygiene alone.~   "
107792|NCT02156505|"~     Self-expandable metallic stents provide effective palliation of malignant gastric outlet~     obstruction. However, uncovered stent are often associated with re-stenosis caused by tumor~     in-growth through the stent mesh. The Self-expandable metallic stents which has the design of~     smaller wire mesh size (double bare stent) were developed and used in Korea. This new design~     was developed to minimize the re-stenosis of uncovered stent, but the outcome is unknown. The~     end point of this study is the 8-weeks patency rate after placement of double bare as well as~     technical and clinical success rates.~   "
107793|NCT02156492|"~     The main purpose of this study is to investigate how the body responds to evacetrapib and to~     evaluate the safety and the effect of evacetrapib, alone and in combination with selected~     statins, in healthy Chinese participants. The study has 2 parts. Part one will last up to 4~     weeks and part two will last up to 5 weeks, not including screening. Participants may only~     enroll in one part.~   "
107794|NCT02156479|"~     This study in a cohort of allo-HSCT recipients aims to validate the suitability of an~     improved T-Track® CMV assay to assess the functionality of CMV protein-reactive effector~     cells and its suitability to determine cut-off values mediating protection from recurrent CMV~     reactivations in allo-HSCT recipients.~      Lophius T-Track® CMV represents a highly standardized and sensitive diagnostic tool to assess~     the functionality of a network of clinically relevant CMV-reactive effector cells. It is~     based on the stimulation of peripheral blood mononuclear cells (PBMC) with activated~     immunodominant CMV proteins, pp65 and IE-1, and the subsequent quantification of CMV-specific~     CMI (spot forming colonies) using a highly sensitive IFN-γ ELISpot.~   "
107795|NCT02156466|"~     This is a multicenter, Phase 1, randomized, double-blind, placebo-controlled trial in~     subjects with moderate to severe psoriasis to assess the safety, tolerability,~     immunogenicity, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of multiple~     subcutaneous ascending doses of MSB0010841 (Anti-interleukin-17A/F [Anti-IL-17A/F] Nanobody).~   "
107796|NCT02156453|"~     Total knee replacement is one of the most successful surgical procedures in Orthopaedics.~     However, 10-20% of the patients are still dissatisfied with the results of the surgery. In~     general, the evaluation of postoperative functional outcomes are usually measured by~     self-report questionnaires, such as the Western Ontario and Mcmaster Universities~     osteoarthritic Index (WOMAC) and the Short Form-36 health survey (SF-36). Another method to~     evaluate functional outcome of the patients is to use the performance-based tests such as the~     two-minute walk test, but there is still little information regarding its use for evaluating~     functional recovery in patients receiving total knee arthroplasty.~      The objectives this study are: 1) to assess the relationship between self-report~     questionnaires and performance-based tests among patients scheduling for TKA; and 2) to~     identify clinical variables that are associated with pre- and postoperative functional~     performance of the patients.~   "
107797|NCT02156440|"~     Osteoarthritis (OA) affects approximately 10% of people older than 60 years, and compromises~     the quality of life of more than 21 million North Americans. Studies on the use of~     complimentary and alternative medicines have reported that OA patients in the US are among~     the highest users of CAM. Previous studies on a unique natural mineral product SierraSil®~     demonstrated an improvement in joint health and function in subjects with mild to moderate OA~     of the knee. Extracts of Sierrasil® are reported to reduce cartilage degradation in response~     to IL-8 and nitric oxide production suggesting an ability to suppress IL-8 mediated events in~     human cartilage. The primary objective is to assess the efficacy of SeirraSil Joint Formula~     versus placebo on the symptoms of osteoarthritis as assessed by WOMAC™ Osteoarthritis Index~     Pain subscale in subjects with osteoarthritis of the knee.~   "
107798|NCT02156427|"~     The purpose of this study is to assess the efficacy of autologous epidermal cells suspension~     grafting using a newly developed device named VITICELL® compared to placebo.~      The secondary objective is to evaluate safety of VITICELL® and global satisfaction of patient~     and investigator.~   "
107810|NCT02156271|"~     The purpose of this study is to help scientist better understand the effect of a 12-week~     single daily evening dose of ramelteon (Rozerem ©), a drug that has been approved by the U.~     S. Food and Drug Administration (FDA) for the treatment of insomnia (trouble falling asleep~     or staying asleep). The study will measure levels of inflammation, fasting insulin and~     fasting glucose (sugar) in subjects who are taking either ramelteon (8 mg) or placebo.~   "
107811|NCT02156258|"~     This is a case collection study of breast images using standard and new mammography~     technology.~   "
107974|NCT02154126|"~     The purpose of this clinical investigation is to evaluate the accuracy of the Senseonics~     Continuous Glucose Monitoring System (Senseonics CGM System) measurements when compared with~     reference standard measurements (YSI glucose analyzer). The investigation will also evaluate~     safety of the Senseonics CGM System usage, while in the clinic and during home use.~   "
107799|NCT02156414|"~     Prostate cancer is considered the fourth most common malignancy cancer in America. However,~     in Colombia the incidence is higher, and it is considered the second cause of death among men~     for malignance diseases. In the framework of clinical localized prostate cancer there is a~     controversy regarding the best predictors of risk and the best treatment options. The actual~     literature is discussing the possibility of underestimate the disease and actual tools are~     not sufficient for proper characterization. Is in this context that extended pelvic~     lymphadenectomy emerges as a stratification tool in prostate cancer that defines the real~     commitment of the disease. The investigators need to know the characteristics that the~     disease has on the investigators community so the investigators can generate appropriate~     therapeutic approach. Thus, the present prospective observational-descriptive multicenter~     study, want to determine in three referral centers in Bogotá Colombia , the frequency of~     pelvic node involvement in patients with localized clinical prostate cancer from the~     stratification achieved by pelvic lymphadenectomy extended.~   "
107800|NCT02156401|"~     Venous thromboembolism (VTE) with its two clinical manifestations deep vein thrombosis (DVT)~     and pulmonary embolism (PE) is a life-threatening disease that is associated with~     considerable morbidity and mortality. The incidence of VTE increases with age and it - as the~     third most common cardiovascular disease after ischemic heart disease and stroke - represents~     an important public health problem in industrialized countries with several aspects in need~     to be addressed.~      VTEval Project includes three long-term prospective observational studies to evaluate and~     improve VTE diagnostics and management, treatment and outcome. The aims of the project~     include a systematic assessment of VTE, i.e. disease status (symptoms, clinical and~     subclinical aspects) and risk profiles (classic, psychosocial and environmental factors),~     using a system-oriented approach. VTEval collects three large prospective cohorts of patients~     with suspected and incident VTE consisting of individuals with a clinical suspicion of acute~     PE, individuals with a clinical suspicion of acute DVT, and individuals with incidental~     diagnosis of VTE).~      The standardized and harmonized data acquisition of the study establishes a sustainable~     resource for comprehensive research on VTE, thus providing the basis for both short- and~     long-term analysis.~   "
107801|NCT02156388|"~     This study is designed to access the safety, tolerance and~     Pharmacokinetic/Pharmacodynamic(PK/PD) of single subcutaneous(SC) injection of GW003 in~     patients with metastatic tumors.~   "
107802|NCT02156375|"~     The purpose of this study is to evaluate the pharmacokinetic (PK) (blood levels)~     comparability of 2 different formulations of ustekinumab, 90 milligram per milliliter (mg/mL)~     liquid in vial (LIV) and 5 mg/mL LIV, following a single intravenous administration of 6~     milligram per kilogram (mg/kg) ustekinumab, diluted in saline, in healthy participants.~   "
107803|NCT02156362|"~     It is generally estimated that 5 % of patients with thyroid cancer will develop distant~     metastases, and most of them had an advanced stage of the disease at presentation. Thirty per~     cent of them are resistant to radio iodine therapy and are called refractory. Their long~     term survival is estimated to be less than 10 %.~      The objective of this study is to identify the factors associated with poor outcome in a~     cohort of patients with advanced thyroid cancer followed during 5 years. Anaplastic and~     medullary thyroid carcinomas were excluded.~   "
107804|NCT02156349|"~     This study is a German, prospective, multicenter, controlled, cluster-randomized,~     interventional comparative study evaluating the efficacy and benefits of integrated PDM care~     by measuring HbA1c levels in patients with Type 2 Diabetes. Patients will be randomized into~     two groups to use Accu-Chek Smartpix software and Accu-Chek Smartpix device.~   "
107805|NCT02156336|"~     The purpose of this trial is to determine if patients suffering from diabetic peripheral~     neuropathic pain treated with ranolazine will have a greater reduction in pain compared to~     placebo.~      Hypothesis: From the prior clinical observations, and analgesic efficacy in the preclinical~     animal model of neuropathic pain, the investigators hypothesize that subjects randomized to~     ranolazine will show a greater reduction in diabetic neuropathic pain compared to placebo.~   "
107806|NCT02156323|"~     This single center, open-label, randomized study will investigate the drug-drug interaction~     potential between multiple doses of RO7033877 and multiple doses of colistin methanesulfonate~     sodium (CMS).~   "
107807|NCT02156310|"~     Background: High blood pressure is a common complication observed in cancer patients~     prescribed anti-VEGF drugs. Increased blood pressure increases the risk of heart attacks and~     strokes, thus adversely affecting survival and quality of life in this patient group.~     However, little is known about the mechanisms leading to high blood pressure with anti-VEGF~     drugs. As a result, the management of anti-VEGF drug-induced hypertension is largely~     empirical. A better knowledge of effects of specific blood pressure lowering drugs, i.e.~     antihypertensives, on anti-VEGF drug-induced hypertension would optimize therapeutic~     management and reduce the risk associated with hypertension and proteinuria in patients with~     cancer.~      Methods: Datasets of two completed GSK clinical trials using the anti-VEGF drug pazopanib,~     i.e. VEG108844 and VEG105192, will be accessed to 1) determine the way blood pressure changes~     over time after commencing anti-VEGF treatment; 2) identify whether there are any~     relationships between pre-study and baseline blood pressure values, treatment with specific~     antihypertensive drugs, and changes in blood pressure after commencing anti-VEGF treatment;~     and 3) identify whether specific antihypertensive drugs and drug combinations, prescribed~     either before or after commencing anti-VEGF treatment, lead to a better blood pressure~     control and prevent proteinuria during anti-VEGF treatment. Specific statistical analyses~     will be conducted to assess and identify associations and will account for other patient's~     characteristics and repeated observations over time. The investigators plan to conduct this~     study over 6 months.~      Studies VEG108844 and VEG105192 have been selected as they investigate the same anti-VEGF~     drug, pazopanib, in a homogeneous group, i.e. patients with renal cancer. At the same time,~     inclusion of a placebo arm as well as a treatment arm with a different anti-VEGF drug,~     sunitimib, will allow initial comparisons across different groups.~      The results deriving from this study will provide important knowledge on 1) patterns of blood~     pressure changes with anti-VEGF drugs and 2) whether specific antihypertensive drugs or drug~     classes might be better than others in preventing and managing anti-VEGF induced hypertension~     and proteinuria.~   "
107808|NCT02156297|"~     It is a prospective, non-interventional, open-label study, in order to observe the safety and~     response in FLT3-ITD mutation positive AML patients who receiving sorafenib as induction,~     consolidation, salvage, maintenance or alleviative treatment. The duration of the study from~     June 2014 through May 2019, with the recruitment duration from June 2014 to May 2017. The~     inclusion criteria is:~        1. Definitely diagnosed as AML~        2. FLT3-ITD mutation has been confirmed~        3. Accepting the prescription of sorafenib~   "
107959|NCT02154321|"~     The purpose of this research is to assess and determine brain oscillations or brain~     signatures of adult participants with Attention Deficit Hyperactivity Disorder (ADHD)~     relative to adult participants without ADHD using the technique electroencephalogram (EEG).~     Electroencephalogram is entirely non-invasive way of tracking brain activity.The main goal of~     this study is to establish biological factors for determining the diagnosis of Attention~     Deficit Hyperactivity Disorder (ADHD).~   "
107812|NCT02156245|"~     The aim of this study is to assess the efficacy of a rehabilitation protocol based on~     individualized combined eccentric and concentric cycle ergometer training compared to~     classical concentric cycle training among patients with either coronary artery disease (CAD)~     or chronic obstructive pulmonary disease (COPD). This study will therefore evaluate the~     efficacy of combined eccentric/concentric training on physical capacity and overall autonomy,~     and will analyse the adaptive mechanisms with regard to both adaptation to cardiac and~     muscular effort and tolerance.~      The research will take place in 3 phases:~      PHASE 1 (DURATION 6 MONTHS):~      30 healthy volunteers will be included to test tolerance to personalized exercise on an~     eccentric cycle ergometer.~      PHASE 2 (DURATION 6 MONTHS):~      15 patients suffering from coronary artery disease (CAD) and 15 patients suffering from~     chronic obstructive pulmonary disease (COPD) will be included to test the same protocol.~      PHASE 3 (DURATION 24 MONTHS):~      A total of 169 patients split into 2 parallel groups will be included: a group receiving~     conventional rehabilitation (group A) and the other group receiving eccentric exercise~     combined to conventional rehabilitation (group B).~      Coronary patients: 93 patients will be included (62 patients in group A and 31 in group B).~      COPD patients: 76 patients will be included (38 patients per group).~   "
107813|NCT02156232|"~     The purpose of this study is to determine whether transjugular intrahepatic portosystemic~     shunt (TIPS) combined with large spontaneous portosystemic shunts embolization are effective~     in the prevention of refractory hepatic encephalopathy (HE).~   "
107814|NCT02156219|"~     The purpose of this study is to determine whether the separation of men and women in the~     metro of Mexico City leads to an improvement in the violence and perception of violence~     towards women.~   "
107815|NCT02156206|"~     The purpose of this study is to determine whether the 123 women emergency phone line of~     Medellin (Colombia) leads to a reduction in the violence suffered by women, as well as in~     their psychological wellbeing and attitudes towards violence.~   "
107816|NCT02156193|"~     Although endoscopic colonic polypectomy has been an established procedure for two decades,~     the risk of bleeding is still higher after resecting of pedunculated polyps, because of the~     presence of a large artery in the stalk. Preventive methods such as endoloop and epinephrine~     injection have been proposed in the management of postpolypectomy bleeding in large colonic~     polyps. For prophylactic clip, there was no randomized controlled study assessing the~     efficacy in the prevention of postpolypectomy bleeding for the large pedunculated polyps. So~     the investigators designed a randomized controlled trial to confirm the efficacy of~     application of prophylactic clip in the prevention of postpolypectomy bleeding in large~     polyps.~   "
107817|NCT02156180|"~     In this study the Investigators aim to determine specific volatile compounds present in~     breath samples of patients with oral cavity or oropharyngeal squamous cell carcinoma before~     and after tumour resection or before and after chemotherapy +/- radiotherapy using gas~     chromotography-mass spectrometry. The Investigators hypothesize that study participants with~     a tumour will display a distinct set of volatile organic compounds than can serve as~     potential cancer biomarkers.~   "
107818|NCT02156167|"~     The purpose of this study is to evaluate the effect of the sound processor upgrade from the~     C-DACS investigational device Freedom sound processor to the Nucleus® CP810 sound processor~     for the Codacs™ system on the speech reception threshold in noise, to evaluate the usability~     of the Codacs™ Fitting Software, to evaluate the quality of life with the Nucleus® CP810~     Sound Processor for the Codacs™ system, to collect long term data, to evaluate the acceptance~     criteria of the postoperative Codacs™ system test and to evaluate the usability of the~     Codacs™ Test System.~   "
107819|NCT02156154|"~     Some patients have respiratory depression (decreased breaths per minute) after surgery.~     Acetaminophen, an FDA approved pain medication, may prevent this problem. The purpose of this~     study is to determine if acetaminophen decreases respiratory depression after surgery. The~     investigators will also evaluate the cost effectiveness of acetaminophen.~      Patients having elective major abdominal surgery are being asked to participate in this~     research study. If eligible, a patient will have their baseline tidal volume (amount of air~     moved into or out of the lungs) and vital capacity (how much air the lungs are capable of~     holding) measured using a spirometer (apparatus for measuring the volume of air inspired and~     expired by the lungs) measured before surgery. Three questionnaires will also need to be~     completed before surgery.~      The patient will then be randomized, like flipping a coin, to receive either Acetaminophen or~     placebo (inactive substance) as an infusion throughout surgery and for the first two days~     thereafter. Neither the patient nor his or her physician will know if the patient is assigned~     to study drug or placebo. Regardless of study assignment, both groups will receive standard~     pain management medications and sedation.~      After surgery, the patient's blood pressure, activity, posture, respiratory rate, the~     electrical activity of the heart, oxygen saturation, tidal volume, minute ventilation and~     respiratory rate will be continuously monitored and recorded for 48 hours using a wireless~     pulse-oximeter and a respiratory volume monitor.~      48 hours after surgery the patient will be asked to complete a patient satisfaction~     questionnaire, which will allow the patient to rate the satisfaction with the treatment~     received for pain. The patient will also be asked to complete a questionnaire about recovery.~      At discharge, the patient will be given two questionnaires about pain and quality of life.~   "
107820|NCT02156141|"~     We want investigate if high intensity training can increase daily functionality without~     causing muscle damage in patients Spinal and Bulbar Muscular Atrophy . We want to study if~     there is a difference in effect with supervised and unsupervised training. Furthermore we~     want to study if a supervised training program will motivate participants to continue~     training by the end of the program.~   "
107821|NCT02156128|"~     The aim of this study is to examine if repetitive computerized cognitive training improves~     working memory in patients who are on sick leave due to complex symptom disorders (chronic~     pain, chronic fatigue, anxiety, depression and or sleep disorders), and whether effects of~     cognitive control training transfer to other tasks.~   "
107822|NCT02156115|"~     Background:~      - Lymphatics are a type of vessel, similar to arteries and veins. Lymphatic disorders happen~     when these vessels don t work properly. Researchers want to look for a relationship between~     lymphatic disorders and variations of certain genes found in the lung, blood, and other~     places in the body.~      Objective:~      - To learn more about lymphatic disorders and evaluate how genetic factors affect lymphatic~     disorders.~      Eligibility:~        -  People ages 2 90 who have a lymphatic disorder or relatives of people with lymphatic~          disorders.~        -  Healthy volunteers 18 and older.~      Design:~        -  Participants may have 1 2 visits a year, or more as needed. The study is expected to~          last 5 years. Visits may last 1 5 days. Participants may have lab tests, medical~          history, and physical exam at each visit.~        -  Participants may have blood testing that includes genetics tests, and urine tests. They~          may have nose and throat cultures, saliva collection, and cheek swabs to collect~          samples.~        -  Participants may have a skin biopsy and have blood taken from an artery.~        -  Participants may have breathing tests and be studied while exercising.~        -  Participants may have an electrocardiogram. Electrodes will be placed on their chest,~          tracing heart rhythms. They may also have chest X-rays.~        -  Participants may have a bronchoscopy. A thin, flexible instrument will be passed through~          the nose or mouth, into the lung. A tissue sample will be taken.~        -  Participants who have lymphatic disease or have a relative with it may also have:~        -  CT scans. They will lie on a table and hold their breath while their chest is scanned.~        -  MRI. They will lie flat on a table that slides in and out of a scanner.~        -  ultrasound. A probe is rolled around outside the abdomen.~        -  removal of fluid around the lungs, chest, and abdomen.~   "
107823|NCT02156102|"~     Background:~      - People with sickle cell disease and other blood disorders sometimes get chronic leg ulcers.~     These are wounds that develop on the skin and don t go away. Current treatments do not work~     very well, so researchers want to learn more about why the ulcers happen. They want to find~     out which bacteria may cause it, and if external factors play a role.~      Objective:~      - To study social and environmental factors of sickle cell disease and the causes of sickle~     cell disease leg ulcers.~      Eligibility:~      - People age 18 and older who have sickle cell disease or another red cell disorder, with or~     without an active leg ulcer.~      Design:~        -  Participants will have a medical history and clinical evaluation. They will also have~          blood drawn.~        -  Participants will complete questionnaires about their life, health, environment, stress,~          and other topics.~        -  Participants may provide a small sample of hair.~        -  Participants will be asked to collect a small amount of saliva.~        -  Participants with leg ulcers will have their skin microbiome sampled. The microbiome is~          all of the microbes (bacteria and and/or fungi) and their genes in and on the body.~          Researchers will use swabs to collect skin samples. Photographs will be taken of the~          skin sample area.~        -  Some participants without leg ulcers also will have their skin microbiome sampled.~        -  Some participants who have their skin microbiome sampled will return for a second visit.~          At this visit, their microbiome will be resampled. It will take place more than 30 days~          after the first visit.~   "
107824|NCT02156089|"~     Background:~      - People with attention-deficit hyperactivity disorder (ADHD) often have problems with~     motivation and rewards. . Omega-3 fats have helped symptoms of ADHD improve in children.~     Researchers want to learn more about the brain activity of people with ADHD and see how~     taking omega-3 fats might help.~      Objective:~      - To learn more about how omega-3 fats affect brain activity and ADHD symptoms.~      Eligibility:~      - Adults age 18 55 with ADHD symptoms.~      Design:~        -  Participants will be screened with medical history and review of medical records.~        -  For study visit 1, participants will have a medical examination and be interviewed to~          confirm they have ADHD. They will have an IQ test and give blood and urine samples.~          Height, weight, and blood pressure will be measured. They will also need to sign consent~          to agree to take part in the study. They will be asked to complete a food diary for 4~          days~        -  For visit 2, participants will give a blood sample. They will complete questionnaires~          about their mood and ADHD symptoms.. They may give a blood or saliva sample for genetic~          testing.~        -  Participants will have a magnetic resonance imaging (MRI) scan. They will lie on a table~          that slides in and out of a metal cylinder. It makes loud noises; participants will get~          earplugs. This scan examines the structure of the brain.~        -  Participants will have a functional MRI scan. This scan measures the function of the~          brain while the volunteer is performing tasks in the scanner. They will stop ADHD~          medications 48 hours before this scan.~        -  Participants will receive key-lime flavored omega-3 smoothie mix or placebo to takeevery~          day~        -  For visit 3, participants will give blood samples and complete questionnaires.~        -  For visit 4, participants will be weighed and have a blood test and MRI scans as per~          before. They will repeat the questionnaires and will guess whether they received the~          omega-3 or placebo.~   "
107825|NCT02156076|"~     The purpose of this study is to evaluate the effect of BMS-919373 on atrial fibrillation (AF)~     through its effect on AF burden (AFB), or the percent of time in AF, in subjects with~     paroxysmal AF (pAF) when administered orally at a range of doses (2 mg once daily (QD), 5 mg~     QD, 12 mg QD following a 1-week period of loading doses of 3 mg QD, 8 mg QD and 20 mg QD,~     respectively) for a total of 4 weeks. It is hypothesized that treatment with BMS-919373 will~     reduce AF burden as compared to baseline relative to placebo.~   "
107826|NCT02156063|"~     This is a randomised, double blind, multi-center, placebo-controlled study of subcutaneous~     NT100 in pregnant women with a history of unexplained recurrent pregnancy loss. Approximately~     150 participants will be randomised to receive subcutaneous NT100 or placebo.~   "
107827|NCT02156050|"~     Jaundice occurs in most newborn infants. Most jaundice is benign, but because of the~     potential toxicity of bilirubin, newborn infants must be monitored to identify those who~     might develop severe hyperbilirubinemia an, in rare cases, acute bilirubin encephalopathy or~     kernicterus. Jaundice is a commonly observed, usually harmless condition in newborn infants~     during the first week after birth. However, in some babies the amount of bilirubin pigment~     can increase to dangerous levels and require treatment. Treatment of jaundice in newborn~     infants is done by placing them under phototherapy, a process of exposing their skin to light~     of a specific wavelength band. Fluorescent tubes or halogen lamps have been used as light~     sources for phototherapy for many years. A light-emitting diode (LED) is a newer type of~     light source which is power efficient, has a longer life and is portable with low heat~     production. Several technologies and devices are developed around this LED and specially a~     compact system.~      The purpose of this study is to evaluate efficacity of LED phototherapy by comparing with~     conventional phototherapy (non-LED) and satisfaction of the parents and the professional~     staff about comfort of this new technology. The newborn infant is placed in a sleeper with~     the device B' bloo ® which maintains him in position (lap or dorsal) allowing to pass the~     blue light. This one is generated by the module LED and transmitted in the braid of optical~     fibers which takes place directly on the mattress of the cradle in which is placed the~     patient usually.~      The device is endowed with an hour counter to schedule the time of treatment. The energy~     illumination varies between 3 and 4 mW / cm ² for an average 3,6 mW / cm ².~   "
107828|NCT02156037|"~     To compare a comprehensive diabetes team care condition (IC) involving the diabetes team's~     use of a diabetes dashboard with a usual diabetes team care condition (UDC) that does not~     have access to the diabetes dashboard.~   "
107829|NCT02156024|"~     The purpose of this study is~        1. To determine whether the Gastrodia and Uncaria Drink is effective in the treatment of~          masked hypertensive patients below 70 years.~        2. To find out the suitable groups for the Gastrodia and Uncaria Drink treatment.~   "
107830|NCT02156011|"~     The objective of this research is to synchronously assess in vivo loading data of the knee~     joint, tibio-femoral 3D kinematics by means of automated video-fluoroscopy, whole leg~     kinematics by means of skin markers, ground reaction forces, as well as muscle activity~     patterns in 4 to 6 subjects with instrumented total knee arthroplasty (TKA) during dynamic~     functional activities of daily life. The comprehensive in vivo dataset will provide unique~     information to evaluate the relationship between the kinematics, respectively the alignment~     of the TKA, and the resulting loading of the implant in vivo.~      The whole data package will be made available for download on a public database, such that it~     can be utilized for the testing and improvement of TKA designs as well as for the validation~     and improvement of musculoskeletal modelling by researchers around the world.~   "
107831|NCT02155998|"~     This is a multicentre, non-interventional, prospective study to be carried out in~     representative medical institutions in order to get the information on administration of~     postoperative and post-radiation adjuvant androgen deprivation therapy (including go / no~     go decision, regimens, dosages and duration) used in locally advanced prostate cancer~     patients with high and very high risk of recurrence in Russia.~   "
107832|NCT02155985|"~     Since people started taking HIV medications, illness from AIDS has decreased, but other~     serious diseases like heart disease, cancer, and kidney, and liver disease have increased.~     HIV causes inflammation (irritation) inside the body that cannot be felt but can be measured~     by blood. Inflammation can lead to diseases that have become some of the leading causes of~     death in people with HIV. HIV therapy can partially lower levels of inflammation measured in~     blood, however, levels of inflammation in people who have HIV may remain high compared with~     people not infected with HIV.~      Aspirin is a drug that is commonly used for pain relief but is also approved by the Food and~     Drug Administration (FDA) for preventing heart attacks and stroke in those who are at~     increased risk for heart attack and stroke. Aspirin also is used (but is not approved by the~     FDA) to decrease the risk of some cancers in people who are at increased risk. Aspirin is~     thought to decrease risk of heart attack and stroke because it blocks the activation of~     platelets and prevents blood clots from clogging narrowed blood vessels, a disease called~     atherosclerosis. It is unknown how aspirin might decrease the chance of developing cancer in~     some people at higher risk, but aspirin has been shown to modulate (or change) the immune~     system. In HIV-infected people who have been taking antiretroviral therapy and have an~     undetectable HIV viral load it was recently shown that low-dose aspirin 81 mg (baby aspirin),~     given for one week, lowers platelet activation and reduces blood markers of inflammation~     which may improve the function of the immune system.~      The purpose of this study was to evaluate whether aspirin improves inflammation and immune~     activation when compared to a placebo (inactive medication like a dummy pill) and to~     determine if 12 weeks of aspirin 300 mg and aspirin 100 mg is safe for HIV-infected persons~     on antiretroviral therapy. Additionally, it studied whether a higher dose and longer duration~     of aspirin provides further anti-inflammatory and immune-modulating benefit. This was done~     using blood and urine tests that measure inflammation and also with a test that uses~     ultrasound to measure the flow of blood in your arm, called flow-mediated vasodilation (FMD)~     of the brachial artery (BART). This is a painless test that bounces sound waves off of a~     blood vessel in your arm.~   "
107833|NCT02155972|"~     This is an 8-week randomized, double-blind placebo-controlled proof of concept study~     assessing the combination of a mood stabilizer + Align in the treatment of participants with~     a bipolar depressive episode. The study has two treatment arms: mood stabilizer plus placebo~     and mood stabilizer plus Align.~      The dose of mood stabilizer will be in accordance with clinical practice guidelines and the~     dose for Align will be 1 capsule per day as per appropriate product dosing.~   "
107834|NCT02155959|"~     Abstract Purpose: To evaluate the visual performance and rotational stability of the Tecnis~     Toric one-piece IOL (AMO, USA) during the first 3 post-operative months Design: Prospective~     single center study Setting: VIROS - Vienna Institute for Research in Ocular Surgery, a Karl~     Landsteiner Institute, Hanusch Hospitel, Vienna, Austria Methods: In this prospective study~     patients with age-related cataract and corneal astigmatism of 1.0 to 3.0 D measured with the~     IOL-Master 500 (Carl Zeiss Meditec AG, Germany) were included. Pre-operatively, rotating~     Scheimpflug scans (Pentacam HR, Oculus, Germany) were performed and the cornea was marked in~     the sitting position at the slit lamp. Patients recieved a single-piece toric hydrophobic~     acrylic IOL (Tecnis Toric, AMO, USA). Immediately and 3 months after surgery~     retroillumination photographs were taken to assess the rotational stability of the IOL.~     Additionally, Autorefraction (Topcon, USA), subjective refraction, uncorrected and distance~     corrected visual acuity, keratometry, Scheimpflug and ocular wavefront (WASCA, Carl Zeiss~     Meditec AG, Germany) measurements were performed at the 3 months follow-up.~   "
107835|NCT02155946|"~     The aging US population threatens to overwhelm our healthcare infrastructure, especially~     since the rate of Alzheimer's disease (AD) alone is expected to triple in the coming decades.~     Memory cause functional impairment, reduced quality of life, increased caregiver burnout, and~     eventual institutionalization. The diagnosis of mild cognitive impairment (MCI) identifies~     those with memory deficits but who remain relatively independent in everyday life. MCI~     provides a window for interventions that target memory functioning. The proposed study~     focuses specifically on a groundbreaking combination of mnemonic rehabilitation and~     non-invasive brain stimulation. The main idea is that brain stimulation can enhance~     functioning in the specific brain regions/networks, thereby increasing the patients' ability~     to benefit from different types of memory rehabilitation. This will be a randomized,~     double-blind study (active vs. fake brain stimulation), that provides multiple treatment~     session. Outcome will be examined using both laboratory-based and real-world memory testing~     as well as brain imaging. This first-of-its-kind study has the potential to meaningfully~     translate more basic science findings into neuroanatomically targeted and functionally~     meaningful treatments for our aging population.~   "
107836|NCT02155933|"~     Hormones are substances that are made by the body and are sent directly out into the~     bloodstream to increase or decrease the function of certain organs, glands, or other~     hormones. Testosterone is a hormone found in the blood of all girls, but some girls have too~     much testosterone in their blood. Too much testosterone in the blood can possibly lead to a~     problem called polycystic ovary syndrome (PCOS). People with PCOS have abnormal menstrual~     periods, excess facial and body hair, and too much testosterone in their blood. On the other~     hand, some girls with too much testosterone in their blood do not develop PCOS. We do not~     know why some of these girls develop PCOS and why some do not. The purpose of this research~     study is to find out whether too much testosterone can cause problems with other hormones~     that can lead to the development of PCOS. This study may help us understand more about the~     causes of PCOS.~   "
107837|NCT02155920|"~     The purpose of this study is to evaluate the anti-tumor activity of Everolimus among children~     with recurrent or progressive ependymoma. Recurrent or progressive ependymoma is incurable~     and has very limited treatment options. The rationale for this study is based upon both~     pre-clinical and clinical considerations: Immunohistochemistry studies have demonstrated that~     20 out of 23 (87%) pediatric ependymomas are immunoreactive for phosphorylated S6, a~     biomarker that often predicts response to mTOR pathway-targeted therapy. Furthermore,~     children with with multiply recurrent ependymomas have had objective and durable responses to~     the mTOR inhibitor, Sirolimus (Rapamune, Pfizer). As a result of this pre-clinical and~     clinical data, this study will further investigate the activity of an mTOR pathway inhibitor,~     Everolimus, against children with recurrent or progressive ependymomas. In this study,~     Everolimus will be administered at a dose and schedule that have previously been demonstrated~     as safe and effective in children. Children may take Everolimus for up to 2 years on this~     study, until tumor progression or unacceptable toxicity.~   "
107838|NCT02155907|"~     Purpose~        1. To validate 2 -day loop recording ( R.Test Evolution 4 ) to 2 -day Holter recording~          (gold standard) for the detection of atrial fibrillation of ≥ 30 seconds duration in a~          consecutive population of patients with stroke or transient ischemic attack (TIA).~        2. To determine whether short run of atrial fibrillation (< 30s ) or the presence of many~          supraventricular extrasystoles detected on Holter recording, is associated with risk of~          re-stroke in a consecutive population of patients with stroke or TIA .~        3. To test whether a 7-day Loop Recording (R -test) detects more patients with atrial~          fibrillation than 2 days of Holter recording in a consecutive population of patients~          with stroke or TIA.~   "
107839|NCT02155894|"~     The study aims to investigate the effect a systematic telemedicine intervention, based on the~     tigth control principals, as a platform for disease monitoring among patients with rheumatoid~     arthritis.~      It is hypothesized that:~        -  A systematic telemedicine intervention targeted to tight control of disease activity~          among patients with RA will be equally effective as usual care (outpatient consultation~          by a rheumatologist).~        -  There will be no difference in the effect whether this telemedicine consultation is~          carried out by a rheumatologist or a rheumatology nurse.~        -  Patient satisfaction and the patient's general perception of involvement in their~          treatment will be increased for patients who receive the telemedicine intervention.~        -  All the effects will apply both in the short term (< 6 months) and in the long term (> 1~          year).~   "
107840|NCT02155881|"~     The purpose of this study is to explore the efficacy and safety of Ciclesonide Nasal Spray~     200 microgram (mcg) once daily in the treatment of seasonal allergic rhinitis (SAR) in~     Russian participants.~   "
107841|NCT02155868|"~     Cerebral oximetry employing near-infrared spectroscopy (NIRS) is a non-invasive modality used~     to estimate regional cerebral oxygen content saturation (rSO2). Near-infrared spectroscopy~     has increasingly been used in perioperative setting of heart surgery and many studies have~     outlined an increased incidence of postoperative morbidity in patients with significant~     perioperative reductions in rSO2. Although a relationship between rSO2 reductions and adverse~     outcomes has been reported, there is not compelling evidence that interventions to correct~     rSO2 during cardiac surgery lead to improved clinical outcomes.~      Hypothesis of the study is that interventions to normalize intraoperatively decreased~     cerebral rSO2 would reduce the overall incidence of postoperative complications in high-risk~     cardiac surgery patients.~   "
107842|NCT02155855|"~     Investigators hope that providing patients and families with additional ways of communication~     with the diabetes care team will improve diabetes control.~   "
107843|NCT02155842|"~     The purpose of this study is to determine whether endurance exercise of either high or~     moderate intensity can reverse structural and functional changes of the heart in patients~     with diastolic heart failure, and to investigate which type of exercise is best in terms of~     aerobe capacity and quality of life.~      The investigators expect that high intensity endurance exercise is superior to moderate~     intensity endurance exercise.~   "
107844|NCT02155829|"~     The purpose of this study is to determine whether Riluzole is effective in the augmentation~     treatment of post-traumatic stress disorder (PTSD) that is experienced by Active Duty~     military service members and Operation Enduring Freedom (OEF), Operation Iraqi Freedom (OIF),~     and Operation New Dawn (OND) veterans who have not had symptom reduction after one or more~     kinds of medications or therapies.~   "
107845|NCT02155816|"~     The purpose of this study is to determine if supplementation with a mixture of omega 7 and 3~     fats has a favorable influence on blood inflammation and lipoprotein biomarkers in women with~     systemic inflammation compared to omega 3 and placebo.~   "
107846|NCT02155803|"~     ACTHAR Gel has activity in sarcoidosis associated hypercalciuria and calcium dysregulation.~   "
107847|NCT02155790|"~     The Ablative Solutions, Inc. Peregrine System Infusion Catheter is a catheter-based device~     which is intended to be used to ablate the afferent and efferent sympathetic nerves serving~     the kidneys. The catheter is typically inserted via the femoral artery, steered into the~     renal artery, and then delivers, by infusion from its distal end, a neurolytic agent. This~     targets the nerve bundles, which are in the adventitia - a sheath surrounding the artery. The~     aim is to reduce blood pressure in cases of resistant hypertension - seriously elevated blood~     pressure which does not respond to drug treatment.~   "
107848|NCT02155777|"~     Use of oral contraceptives (OCs) reduces a woman's risk of ovarian cancer very significantly~     and the protective effect continues for at least 25 years after use of OCs is stopped; the~     mechanisms of how this occurs are not understood. We are proposing here to directly study the~     effect of OCs on the fallopian tube and inclusion cysts within the ovary - sites from which~     most ovarian cancers are thought to arise - in order to better understand the mechanistic~     basis for OC protection against ovarian cancer. We think the protection results from reduced~     cell proliferation. It will lay the foundation for further studies to ensure that the~     protection against ovarian cancer afforded by 'traditional' OCs is not lost with alterations~     in OC formulation, and, if possible, to guide development of OC formations to improve further~     on the protection afforded by OCs.~   "
107849|NCT02155764|"~     Return to normal life and shortening rehabilitation period of patients after surgical removal~     of teeth is important and urgent social problem. In this regard, higher demands for quality~     of care and treatment of patients, which requires the development of new approaches to the~     treatment of patients, the introduction of new technologies and the associated development of~     new materials . Serious problem of contemporary oral and maxillo-facial surgery and dentistry~     is augmentation of bone defects generated during the surgical treatment of diseases and~     injuries of the bones. The results of surgical repair of bone defects are more dependent on~     the course of the process of reparative osteogenesis. Long-term periods of clinical studies~     indicate that reparative osteogenesis in posttraumatic bone defects is slow - months and~     years, and in some cases no bone defects filled with bone tissue.~      This project aims at addressing the preservation of bone volume in humans after tooth~     extraction using biomaterials with optimum performance. The practical significance of the~     project is to establish an effective tissue response and, thus, possible subsequent quality~     installation of dental implants. The proposed solution is based on the scientific development~     of the operative techniques, and a comparative analysis of several classes of biomaterials~     (xenogenic and synthetic analogs), including the use of biological precursors of bone apatite~     mineralization having osteoinductive (stimulating) properties.~   "
107867|NCT02155530|"~     This study is a prospective randomized trial to evaluate and compare the quantitative and~     qualitative characteristics of neointimal formation between high and low efficacy statin~     treatment after drug eluting stent (DES) implantation, in patients with homogeneous or~     heterogeneous neointimal pattern accessed by Optical Coherence Tomography (OCT). The~     investigators postulate that high efficacy statin could have superior effect on modification~     of neointimal pattern, compared with lower efficacy statin. Our main hypothesis is that~     Atorvastatin 40mg, high efficacy statin might have superior effect on modification of~     neointimal pattern evaluated by serially followed OCT, compared with pravastatin 20mg in~     patients with DES implantation.~   "
107850|NCT02155751|"~     This is a pilot project in which investigators will recruit obese (pre-pregnancy BMI of ≥ 35~     kg/m2) women from the newly developed My Clinic at London Health Sciences Centre as well as~     normal obstetrical care at London Health Sciences Centre.~      Patients will be randomized to one of three treatment groups: 1) the full Nutrition and~     Exercise Lifestyle Intervention Program (NELIP), 2) Nutrition program only, or 3) Exercise~     program only.~      The investigators hypothesize that the evidence-based NELIP for obese pregnant women will be~     feasible to adopt in a clinical setting and will prevent excessive gestational weight gain,~     gestational diabetes and promote healthy infant growth patterns at the 6 and 12 month~     milestones. Outcomes may be improved in My Clinic over normal obstetrical care patients with~     interprofessional services.~   "
107851|NCT02155738|"~     The purpose of this study is to determine whether preoperative IV Acetaminophen reduces~     postoperative pain and narcotic consumption in women undergoing surgical repair of pelvic~     organ prolapse.~   "
107852|NCT02155725|"~     The purpose of the study is to assess the benefits of a therapeutic strategy that associates~     an early administration of human fibrinogen concentrate in the management of PPH on the~     reduction of bleeding after the initiation of prostaglandins intravenous infusion, following~     vaginal delivery.~   "
107853|NCT02155712|"~     The success rate of the Triathlon Tritanium Knee, defined as absence of revision for aseptic~     loosening of the tibial baseplate at 2 years, is no worse than rates reported in the~     literature for cemented devices.~   "
107854|NCT02155699|"~     The goal of this proposal is to test the feasibility and effectiveness of cardiovascular~     exercise in promoting brain health and improving related symptoms (e.g., hearing sounds that~     are not there, feeling emotionally detached from self and others), cognitive difficulties~     (troubles with memory and learning), and every day social-occupational functioning in youth~     at imminent risk for developing a psychotic disorder such as schizophrenia. Understanding how~     exercise may protect or improve the health of a brain area that is implicated as a major~     contributing factor to the onset of psychosis may lead to a path-breaking new intervention~     that does not suffer from many of the side effects, costs, and other barriers that~     characterize treatments that are currently available for this group. Because a significant~     portion of high-risk youth go on to develop a psychotic disorder in a short period,~     intervening at this stage may help to improve the clinical course and ultimately prevent the~     onset of a devastating and prevalent mental illness.~   "
107855|NCT02155686|"~     The elderly or people with disabilities want to remain in their homes even when their health~     condition has been getting worse.~      This project aims to demonstrate that home automation and telemonitoring can lead to develop~     a home safety environment that could help the elderly and individual with disability live~     independently in their own home.~      In this study, the automation sensors containing devices follow up chronic disease clinical~     factors to monitor their biometrical parameters and detect any abnormal prodromal disease~     decompensation via telemonitoring and geriatric expertise.~      The purpose of this study is:~        -  to provide clinical evidence of the effectiveness of automation tools and~          telemonitoring/expertise for the home support for people at risk of loss of autonomy~        -  to demonstrate the clinical benefit of combining the automation and telemonitoring and~          geriatric teleexpertise~   "
107856|NCT02155673|"~     The primary objective of this study is to determine the safety and tolerability of extended~     dosing of GCS-100 in patients with CKD.~   "
107857|NCT02155660|"~     The purpose of the study is to determine if benralizumab reduces COPD exacerbation rate in~     symptomatic patients with moderate to very severe COPD who are receiving standard of care~     therapies.~   "
107858|NCT02155647|"~     This is a multicenter, international, single-arm, open-label, Phase 2 trial to evaluate the~     efficacy and safety of avelumab in subjects with metastatic Merkel cell carcinoma (MCC).~   "
107859|NCT02155634|"~     The purpose of this study is to see how long lenalidomide therapy can maintain or improve the~     disease response obtained after induction therapy that does not include lenalidomide,~     pomalidomide or thalidomide; and consequently reduce worsening of disease and to evaluate the~     activity of lenalidomide. Patients will receive lenalidomide or be under observation. All~     patients will attend regular clinic visits to evaluate their disease and health. Patients~     will have the option to participate in additional biomarker correlative studies in addition~     to their participation in the main study.~   "
107860|NCT02155621|"~     The genomic heterogeneity of cancers implies that to effectively use targeted therapies the~     investigators will need to assess each individual cancer and match it to a biologically~     relevant targeted therapy. The investigators will use full genome sequencing to try to~     identify cancer drivers and corresponding drugs that may inhibit these pathways.~   "
107861|NCT02155608|"~     The purpose of this study is to develop external Trigeminal Nerve Stimulation (eTNS) as a~     potential nonmedication treatment for attention-deficit/hyperactivity disorder (ADHD).~      Study hypothesis address potential differences over 4 weeks of active vs. sham eTNS treatment~     on ADHD symptoms, measures of executive function, electroencephalography (EEG) profiles,~     other dimensional measures of height, weight, mood, anxiety, and sleep, and side effect~     profiles.~   "
107862|NCT02155595|"~     The purpose of this protocol is to determine the risk of atypical femoral shaft (thigh bone)~     fractures after long term fracture prevention therapy with a class of drugs called~     bisphosphonates, colloquially referred to as Alendronate, risedronate, Ibandronate, and~     Zoledronate.~      In addition, the study is designed to find out which patient is most likely to develop this~     potential life changing complication and why. Finally, the results of this study will help~     clinicians to better understand the reason and thus tailor patient specific treatments…i.e.,~     the right treatment for the right patient for right duration.~   "
107863|NCT02155582|"~     This study aims to analyze what the study drug does to the body and its relationship to drug~     levels and safety after patients with advanced cancer have been treated with copanlisib in~     different dose groups.~   "
107864|NCT02155569|"~     The aim of the study is to compare post operative morbidity between extra peritoneal cesarian~     and trans peritoneal cesarean section.~   "
107865|NCT02155556|"~     Aim of this study is to gain a better understanding of the diurnal changes of the cornea to~     improve toric IOL power calculations.~   "
107866|NCT02155543|"~     This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of AGN-223575 in~     healthy subjects.~   "
107868|NCT02155517|"~     Actually, Schnider and Cortinez models represent pharmacokinetics models of propofol more~     complete published until now. Schnider was derived from 24 healhty people, and including~     other covariates in addition to weight, such as age, height and lean body mass though.~     Schnider model should not be used in obese patients. Cortínez model was derived from 20 obese~     patients. The differences between both models has been founded at the initial drug~     distribution, that means V1 and the constant Ke0 ( pharmacokinetics factors that define the~     plasma-effect equilibration time). We believe that Cortinez model also could be used in No~     OBESE patients because is an allometric model, and one way to evaluate and to compare both~     pharmacokinetics models is studying the temporary course of the effect.~      The main objective of our study is to evaluate BIS and Cardiac Output values during~     propofol-induced sedation using Schnider and Cortinez models in Target Controlled infusion in~     non obese healthy volunteer.~   "
107869|NCT02155504|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK)~     of single ascending oral doses of ASP3700 in healthy male subjects. This study will also~     explore the effect of itraconazole (another drug) on the PK of ASP3700, as well as to~     evaluate the safety and tolerability of ASP3700 alone and in combination with itraconazole in~     healthy male subjects.~   "
107870|NCT02155491|"~     The protocol is a large registry to describe acute, sub-acute and extended duration of~     anticoagulation management, clinical and economic duration of anticoagulation management,~     clinical and economic outcomes in patients with treated acute VTE (DVT and PE) in the~     real-world setting.~      Main objectives are to clarify the:~        -  treatment related details for acute VTE (either conventional anticoagulation therapy,~          treatment with a direct oral anti-coagulant or other modalities of treatment)~        -  Rate of early and late symptomatic VTE recurrence~        -  Rate and nature of complications of VTE including post thrombotic syndrome and chronic~          thromboembolic pulmonary hypertension~        -  Rate of bleeding complications~        -  Rate of all-cause mortality at six months~   "
107871|NCT02155478|"~     The pseudoexfoliation (PXF syndrome) is caused by production and deposition of extracellular~     material in the anterior chamber of the eye as well as in other tissues of the body. Approx.~     70 million worldwide have a PXF syndrome.~      After cataract surgery a decentration and subluxation of the intraocular lens (IOL) happens~     more frequently than in the general population due to a higher incidence of zonular weakness~     and an increased capsular fibrotic reaction.~      Decentration, tilt and / or rotation of the lens can reduce the quality of vision.~      It is believed that the design of the implanted IOL, more precisely the front surface of the~     IOL has an influence on the extent of capsular fibrosis and contraction. Especially in~     presence of capsular instability, as it is in patients with Pseudoexfoliation syndrome the~     design of the IOL has an effect on the post-operative stability.~      In this study, two different IOL models are compared in terms of their stability. The Tecnis~     1-piece ZCB00 (AMO, USA), with a concave lowering comprising the lens edge and the Acrysof~     SA60AT (Alcon, USA), with a biconvex design are compared. Forty eyes of 20 patients are~     planned to be included in this study. One eye receives the Tecnis ZCB00 1-piece (AMO, USA),~     while the other eye receives theAcrysof SA60AT (Alcon, USA).~      In which eye which IOL is implanted, is assigned by randomization. To measure the~     decentration, tilt and rotation of the IOL an examination will be performed before the~     operation and there will be follow-ups one hour after the operation of the first eye, one~     hour after the operation of the second eye, three months and twelve months after the~     operation on the second eye. All measurements will be done without touching the eye.~   "
107872|NCT02155465|"~     This is a phase 2 study. The goal of this study is to find out what effects, good and/or bad,~     taking erlotinib and ruxolitinib has on the patients and on lung cancer. Erlotinib and~     ruxolitinib are FDA approved for other indications, but the use of erlotinib and ruxolitinib~     together has not been studied before and is not FDA-approved.~   "
107873|NCT02155452|"~     The investigators aim to study the heterogeneity of fluorescence within malignant gliomas by~     sampling tissues from these variable areas within the same tumor. These tissue samples will~     then be subjected to pathological and biological analysis to assess proteins related to ALA~     metabolism and correlated with the fluorescence emitted as well as levels of protoporphyrin~     IX in the tissues.~   "
107874|NCT02155439|"~     The aim of study is examine the efficacy of intralesional 5-fluorouracil injections in keloid~     disease treatment.~   "
107875|NCT02155426|"~     TITLE : A Multicenter, Prospective, Observational Trial on the Prognostic and Dynamic Change~     of CTC Enumeration in Advanced NSCLC with 1st or 2nd line chemotherapy and targeted therapy~      BACKGROUND : Circulating tumor cells (CTC) identification is a new field of research in~     oncology, and some studies have been conducted with success on breast and prostate cancer.~     Nearly 80% of lung cancers are diagnosed in an advanced stage (IIIB, and IV). CTC~     identification and monitoring these cells after treatment could help the clinicians to detect~     relapse or be a prognostic factor.~      PRIMARY OBJECTIVE : To study the relationship between CTC count and clinical outcome of~     treatment (Overall response rate and Progression-free survival).~      SECONDARY OBJECTIVES :To study the relationship between CTC and overall survival.~      STUDY DESIGN : This is a prospective, observational study.~      Duration of the inclusions: 12months.~      SAMPLE SIZE : 1200 patients~   "
107876|NCT02155413|"~     Acute pain service (APS) was introduced in 1990s at Queen Mary Hospital (QMH) as other~     countries. With accumulation of experience and clinical evidence, APS has been well~     established. A study conducted in 1997 suggested that monitoring, management protocol and~     nursing experience were mandatory to the safety for APS. Our recent study showed that pain~     relief of our post-operative patients using patient controlled analgesic with morphine was~     still not adequate. The results has driven us to continue the improvement of post-operative~     outcomes for our surgical patients. Tolerability and safety are always our concerns for~     patients using our APS. Therefore, the investigators aim to conduct this retrospective study~     in order to assess if the tolerability and safety of our present APS are adequate or not. The~     study results will help us to further improve our APS at QMH if necessary.~   "
107933|NCT02154672|"~     The purpose of this study is to determine the incidence of prostate cancer in men with the~     BRCa2 gene mutation as an independent indicator for prostate cancer screening.~   "
107960|NCT02154308|"~     The purpose of this study is to evaluate the safety and immunogenicity of IL-YANG Inactivated~     Split Influenza Vaccine (IL-YANG FLU Vaccine Prefilled Syringe INJ.) administered as a single~     intramuscular injection.~   "
107877|NCT02155400|"~     Getting cold (not maintaining normothermia) around surgery (perioperative period) leads to~     many negative outcomes for patients including increased wound complications, abnormal heart~     rhythms and increased blood loss. These all lead to increased length of hospital stay and~     higher requirements for post operative monitoring. These add to around $3500 of extra costs~     per patient. The investigators aim to study the effects of a warming device, placed around~     the patient's legs and/or feet, to determine it's safety, efficacy and eventually compare to~     the current gold standard of a forced air warming blanket. Forced air warming has been~     associated with the spread of germs over the surgical field. Hence the need for warming~     equipment that won't do that.~   "
107878|NCT02155387|"~     The use of cardiopulmonary bypass (CPB) combined with one lung ventilation (OLV) allows to~     perform minimally invasive cardiac surgery (MICS) through small incisions. MICS is described~     to be associated with similar outcomes compared with conventional surgery. Although less~     invasive, MICS has not been reported to favorably impact the incidence of respiratory failure~     after surgery.~      The combination CPB and OLV may induce acute respiratory distress syndrome (ARDS). After CPB~     contact of blood components with the artificial surface of the bypass, lung ischemia~     reperfusion injury (LIRI) and operative trauma may trigger a systemic inflammatory response~     syndrome (SIRS). During OLV, ARDS can result from hyperoxia, hyperperfusion and ventilatory~     distress in the ventilated lung as well as from LIRI and operative trauma of the collapsed~     lung.~      Extravascular lung water (EVLW) includes all fluids in the lung except for those in the~     vascular compartment. An excess of EVLW may lead to respiratory insufficiency. This may be~     due to an increased hydrostatic intravascular pressure, as it occurs in cardiogenic pulmonary~     edema, and/or by an increase of lung endothelial and epithelial permeability, as in ARDS. The~     extravascular lung water index (EVLWI) assessed by the transpulmonary thermodilution~     technique may be a useful tool for accurate diagnosis of ARDS, and the pulmonary vascular~     permeability index (PVPI) may help in the differentiation between pulmonary edema due to an~     increase in the pulmonary capillary permeability versus an increase in the pulmonary~     capillary hydrostatic pressure.~      As both CPB and OLV may induce an excess of EVLW, the investigators hypothesize that patients~     after MICS with intraoperative combination of CPB and OLV may have higher EVLWI and PVPI than~     those who received either CPB or OLV alone.~   "
107879|NCT02155374|"~     Objective: to determine which regimen results in best glycemic control and safety profile,~     expressed as glucose values within target range and occurrence of hypoglycemia. Secondary~     objective is to compare patient satisfaction, clinical outcomes and toxicity.~      Study design: Randomized open label cross-over study Study population: Patients ≥ 18 years,~     who developed glucocorticoid induced hyperglycemia requiring initiation or adjustment of~     antihyperglycemic agents in a previous chemotherapy cycle. Patient should have ≥2 cycles of~     chemotherapy scheduled, with 3-10 consecutive days of ≥12,5mg prednisone-equivalent~     glucocorticoid and a wash-out period of 4-38 days between each cycle.~      Intervention: subjects will be treated by insulin regimen A and B in random order during two~     consecutive cycles of chemotherapy. A) intermediate acting insulin 0.01 IU / mg~     prednisone-equivalent / kg body weight once daily subcutaneous B) Short-acting insulin~     according to sliding scale regimen, dose adjusted to current grade of hyperglycemia.~      Main study parameters: Difference in fraction of blood glucose measurements (BGM) within~     target range and occurrence of hypoglycemia.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: Both study treatments are just a slight variation in regular care for~     glucocorticoid induced hyperglycemia. Glycemic control is likely to improve due to treatments~     and increased counselling. All subjects will receive both treatment regimens.~      The burden consists of 16-32 extra BGMs over 2 x 4-10 days, wearing the glucose sensor, 1~     venipuncture (if HbA1c and creatinin are not determined in routine laboratory within 3 months~     before start), and 1 randomization visit to the outpatient clinic. Potential risk is the~     occurrence of hypoglycemia, as is present in any insulin therapy. The investigators account~     for this risk by giving subjects dietary advice and education how to prevent, recognize and~     treat hypoglycemia.~   "
107880|NCT02155361|"~     This study is designed to evaluate the topical Citrullus colocynthis fruit oil efficacy in~     treatment of painful peripheral diabetic neuropathy (PDN) in a randomized double blind~     placebo-controlled clinical trial design. This study includes 60 patients from SUMS~     endocrinology and diabetes clinic. Patients with painful conditions other than PDN such as~     radiculopathies will be excluded. After giving the Informed consent the patients will be~     underwent NCS (Nerve Conduction Study) for confirming the diagnosis before recruitment. They~     will be followed for 12 weeks and after 12 weeks the outcome measures including Neuropathic~     Pain Scale (NPS), WHOQOL-BREF (World Health Organisation Quality of Life Brief) questionnaire~     and electrodiagnostic criteria will be evaluated.~   "
107881|NCT02155348|"~     More and more patients like to achieve complete spectacle independence after cataract~     surgery. Two possibilities that are particularly often used today are on the one hand~     multifocal lenses, and on the other hand the concept of monovision (in doing so one eye is~     adjusted for closeness and the other focuses for distance). The drawback with multifocal~     lenses is that some patients are bothered by glare phenomena, the disadvantage of monovision~     is that some patients lose a little of their stereo vision.~      The aim of this study is a direct comparison of these two methods. Therefore 70 patients are~     included in 2 groups. In one group, patients receive on both sides a multifocal IOL with a~     near addition of +1.5 D and the patients in the second group receive monovision. One hour, 1~     week and 3 months after surgery, patients are invited and tests for visual accuity are~     performed for near vision (40cm), intermediate vision (80cm) and distant vision (400cm).~     Furthermore, contrast sensitivity and stereopsis of patients is assesed. Additional~     measurements for detecting the tilt of the lens will be performed.~   "
107882|NCT02155335|"~     This study is designed to determine whether ulcerative colitis participants prefer delivery~     of golimumab via a prefilled syringe or the Smartject™ device.~   "
107883|NCT02155322|"~     This study will assess the safety of Pegylated Interferon Alfa-2b (PEG-IFN) as an adjuvant~     treatment for melanoma.~   "
107884|NCT02155309|"~     Part 1, the pharmacokinetic (PK) phase, will expand upon the pilot study conducted at Naval~     Medical Research Laboratory (NAMRL) and has the goal of determining bioavailability and time~     to Cmax in a larger representative sample. Part 2, the efficacy phase, is to determine the~     efficacy of the aqueous spray solution via exposure to a nausea-inducing stimulus.~   "
107934|NCT02154659|"~     Gastroesophageal reflux disease is increasing worldwide. The causes of reflux symptoms are~     not found exactly. especially, the postprandial reflux symptoms are more common than the all~     day reflux symptoms. One of the causes of reflux symptoms is the relaxation of the lower~     sphincter of the esophagus. But, the sphincter relaxation also occur in normal people. But,~     there is a difference in postprandial reflux pattens between the patients and the normal~     people. So, in this study, we want to compare the difference of reflux pattern between the~     patients who have postprandial reflux symptoms and normal people though the 24hr pH~     monitoring.~   "
107885|NCT02155296|"~     The Restorative Practices Intervention (RPI), is a whole school environment intervention~     which is integrated into existing school practice (rather than 'added on') so does not~     compete with academic priorities; and it has some evidence supporting its effectiveness at~     improving school environment and promoting positive peer relationships. The specific aims of~     this investigator initiated study are to:~        1. Assess the mechanisms of how RPI implementation influences the school environment;~        2. Assess the effects of RPI on school staff perceptions of school climate and adolescents'~          reports of school connectedness, peer relationships, developmental outcomes (academic~          achievement and social competency) and problem behaviors (alcohol use, bullying,~          disciplinary referrals);~        3. Assess the extent to which the positive effects of RPI on adolescents persist over time~          during the transition between middle and high school.~      For the first time utilizing rigorous scientific methods, this study has the potential to~     document whether a whole-school intervention like RPI, that can be integrated into existing~     school practice, can affect both developmental outcomes and problem behaviors and whether the~     effects persist during the transition from middle to high school.~   "
107886|NCT02155283|"~     The purpose of this study is to evaluate the efficacy of the Kyrobak continuous passive~     motion home-use device in relieving low back pain, improving proprioception (balance and fall~     prevention) and improving the symmetry of muscle function on either side of the spine.~   "
107887|NCT02155270|"~     We would like to evaluate the use of a 600μm pre-cut regarding wound architecture and~     surgically induced astigmatism as compared to a stab-incision (a corneal incision without a~     pre-cut). A dedicated wound architecture score will be used to evaluate wound configuration.~      Postoperatively, OCT scans will be obtained, corneal curvature will be measured and~     subjective and objective refraction will be performed in order to measure the~     surgically-induced astigmatism.~   "
107888|NCT02155257|"~     The purpose of this research study is to test whether or not researchers can alter or change~     expectations on pain. The researchers will test whether there is an effect on the size of the~     pupil and responses to thermal heat temperatures in subjects with osteoarthritis of the knee~     or hip or healthy subjects for comparison.~      One of 3 possible treatment groups will be administered to qualifying subjects: (1)~     gabapentin, a medication that is commonly used to treat nerve pain, (2) modafinil, a~     medication that is commonly used to treat people with narcolepsy (a disorder that causes~     people to fall asleep) and (3) a placebo, which is an inactive substance, like a sugar pill,~     that is not thought to have any effect on your disease or condition~   "
107889|NCT02155244|"~     In unfit elderly people with comorbid disease leaving the gallbladder in situ is justified~     after ERCP treatment. Cholangitis is more present in elderly people. The purpose of this~     study is to determine leaving the gallbladder in situ does not reduce the morbidity rate~     after ERCP for common bile duct stones(CBDS), especially in patients with cholangitis.~   "
107890|NCT02155231|"~     OBJECTIVES~        1. To determine the prevalence and incidence of anal HPV infection, including infection~          with high-risk HPV types, among MSM in Indonesia, Malaysia, and Thailand.~        2. To study the prevalence and incidence of HGAIN among these MSM.~        3. To evaluate risk factors, including HIV status, for anal high-risk HPV infection and~          HGAIN among these MSM.~      Study population An approximately 75 HIV-positive and 75 HIV-negative MSM who attended the~     study clinic in Kuala Lumpur, Jakarta, and Bangkok will be enrolled. The study will also~     enroll 185 HIV-positive and 95 HIV-negative MSM who are previous participants of the MSM VCT~     study. There will be approximately 260 HIV-positive and 170 HIV-negative MSM in total in this~     study.~   "
107891|NCT02155218|"~     In Contrast-Enhanced Magnetic Resonance Angiography (CE-MRA) a contrast agent is injected~     into an arm vein using a programmable medical device called a power injector. Once the~     contrast has circulated to the blood vessel of interest they can be imaged with MRI and~     distinctly separated from surrounding non-vascular tissue.~      This project is designed to find the best way to administer the contrast agent during CE-MRA~     to produce the best images. The clinical availability of programmable power injectors~     facilitates the use of variable contrast rate and volume injection protocols that are based~     on patient specific parameters.~      CE-MRA is a valuable imaging tool for diagnosing abnormalities of the major blood vessels in~     the chest and abdomen. It is often used in conjunction with cardiac magnetic resonance (CMR)~     examinations to evaluate the blood vessels of the heart and lung. CE-MRA is attractive~     because 1) it does not involve radiation, and 2) the contrast agents used are not toxic to~     the kidneys and can be used in patients who are at greater risk for kidney dysfunction~     following iodinated contrast agents.~      We plan to administer a small (1cc) test amount of contrast, taking pictures as the contrast~     passes through the blood vessels, and analyze the results. Using this information, we will~     administer an individually patient-tailored injection given in multiple phases (i.e., a~     multi-phasic injection) to maintain constant contrast concentration (and therefore constant~     signal intensity) throughout the scan. We believe this will reduce image blurring, and~     improve the sharpness and likely the diagnostic quality of CE-MRA.~   "
107892|NCT02155205|"~     The purpose of this study is to demonstrate that telotristat etiprate does not differ from~     placebo in the mean change from Baseline QT interval corrected for heart rate.~   "
107893|NCT02155192|"~     The purpose of this study is to evaluate the association between genetic factors and response~     to treatment (guselkumab, ustekinumab, adalimumab, or etanercept) and psoriasis (scaly skin~     rash).~   "
107894|NCT02155179|"~     The embryo kinetics may be a new prognostic factor for choosing the embryos with the highest~     implantation potential. In order to identify the factors that may affect the rate of embryo~     cleavage, there are many studies about morphokinetics and culture medium, oxygen tension,~     oocyte quality or type of medication used for ovarian stimulation. However there are no~     published data with respect to the influence of semen quality in the embryo kinetic.~      In this study The investigators propose that the sperm quality may has influence in the~     embryo division.~   "
107895|NCT02155166|"~     This study has the objective to evaluate the effect of Injectable intracervical anesthesia in~     comparison with a non-steroidal anti-inflammatory drug (NSAID) on the pain scores immediately~     after insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) in women~     without previous vaginal delivery.~      H0: There is no difference in terms of pain score between the treatments H1: There will be~     difference in terms of pain score between treatments~   "
107896|NCT02155153|"~     Postoperative ileus is generally referred to as the transient impairment of bowel motility~     after abdominal or other surgery and diagnosed by postoperative abdominal pain vomiting~     constipation and distension.~      The potential complications of prolonged POI include increased postoperative pain, increased~     nausea and vomiting, pulmonary complications, poor wound healing, delay in resuming oral~     intake, delay in postoperative mobilization, prolonged hospitalization, and increased~     health-care costs. The estimated economic impact of POI in the United States is $7.5 billion~     per year, excluding the expenses of work loss.~      In view of these complications and economic burden a number of pharmacologic and~     non-pharmacologic strategies have been adopted by the doctors all over the world to reduce~     the burden of postoperative ileus.These programs involve transverse or curved surgical~     incisions, removal of nasogastric tubes at the end of anesthesia, intraoperative and~     postoperative analgesia, early postoperative feeding, mobilization, and gum chewing.~      The use of gum chewing has emerged as a new and simple modality for decreasing POI. And~     reviews have concluded that there is consistent benefit for patients from gum chewing after~     the intestinal surgery; colonic surgery and gynecological surgery.~      This study is based on the hypothesis that postoperative gum chewing is beneficial in~     prevention of postoperative ileus after reversal of ileostomy.~   "
107897|NCT02155140|"~     Patients due to undergo surgery for oesophageal and gastric malignancy are often~     malnourished. Up to 10% of patients preoperative weight may also be lost during the early~     postoperative period. Following discharge from hospital the mechanics of the surgery leads to~     a loss of gastric reservoir function, lack of appetite, altered intestinal motility and~     gastro-oesophageal reflux which usually results in reduced dietary intake and further weight~     loss. In patients who have undergone upper gastrointestinal resections there are no studies~     examining the benefit of nutritional supplementation following hospital discharge, however,~     studies in other groups of surgical patients have failed to show benefit. Despite patients~     who have undergone upper gastrointestinal surgery being 'at risk' nutritionally, there is no~     evidence demonstrating the value or not of nutritional supplementation following hospital~     discharge.~      Hypothesis: The postoperative under nutrition seen after upper gastrointestinal surgery will~     exacerbate the reduced quality of life and fatigue patients' already experience. The~     investigators hypothesise that improving patient's nutritional intake following hospital~     discharge will improve their quality of life and fatigue levels.~   "
107898|NCT02155127|"~     Chronic kidney disease (CKD) affects more than 26 million individuals (13 percent) of the~     U.S. population, with a projected 70 percent increase by the year 2015 to over 40 million~     individuals. Impairments in physical function and mobility limitations have been reported in~     older Chronic Kidney Disease patients, however the consequences of impaired functioning on~     participation in daily life and quality of life have not been studied. Early identification~     and interventions to mitigate deterioration in physical function and mobility should lead to~     improved health and quality of life outcomes in older patients with Chronic Kidney Disease.~     Although older individuals with Chronic Kidney Disease have reduced survival expectancy,~     maintaining physical function and mobility may contribute to longer active life expectancy,~     and higher quality of life despite their diagnosis.~   "
107899|NCT02155114|"~     The purpose of this study is to survey iron storage levels and their prognostic consequences~     in the context of acute inflammation. The impact of iron substitution in inflammatory states~     is controversial. We hypothesize that iron substitution may influence outcome in patients in~     inflammatory states.~   "
107900|NCT02155101|"~     The aim of this pilot study is to assess the feasibility, efficacy and safety of~     Darunavir/ritonavir 800/100 mg once daily (DRV/r) monotherapy as a switch-maintenance~     strategy for patients receiving second-line ART at Yaoundé Central Hospital in Cameroon.~     HIV-infected adults receiving second-line antiretroviral therapy (ART) for ≥3 months with 2~     nucleos(t)ide reverse transcriptase inhibitors (NRTIs) plus either lopinavir/ritonavir~     (LPV/r) or atazanavir/ritonavir (ATV/r) will undergo plasma HIV-1 RNA (viral) load testing.~     Those with a viral load below 50 copies/ml (<50 cps/ml) will undergo a repeat test ideally~     4-6 weeks later (allowed up to 12 weeks); if the viral load is confirmed as <50 cps/ml the~     patient will be invited to join the randomised phase of the study. Patients (n=150) will be~     randomised 1:2 to either continue the current triple ART regimen (n=50) or switch to DRV/r~     monotherapy (n=100). The primary end-point will be viral load suppression <400 cps/ml at week~     24; secondary end-points will be viral load suppression <50 cps/ml at week 12 and week 24,~     safety, tolerability, and emergence of protease inhibitor (PI) drug-resistance. Patients will~     continue observational follow-up depending on the treatment arm they are randomized to. After~     week 48, patients will return to local standard of care. Pharmacokinetics (PK) and~     pharmacogenomics sub-study to correlate plasma concentrations of DRV to outcomes, HIV-1 drug~     resistance testing sub study to detect mutants archived at the time of first-line ART failure~     and measuring HIV DNA load will be performed, as well as a cost-effectiveness analysis will~     test the hypothesis that savings can be achieved by switching to DRV/r monotherapy without~     affecting quality of care. The primary virological objective is to evaluate efficacy in terms~     of the percentage of subjects who have plasma HIV-1 RNA levels <400 cps/ml after 24 weeks of~     follow-up following a switch to DRV/r monotherapy versus continuing triple therapy containing~     2 NRTIs + LPV/r (or ATV/r) (FDA Snapshot method).~      Study hypothesis:~      we propose that maintenance therapy with DRV/r monotherapy is a feasible, effective and safe~     treatment option for patients receiving second-line ART in Yaoundé.~   "
107901|NCT02155088|"~     The main purpose of this study is to see primarily if BYL719 is safe to be given to patients~     in combination with gemcitabine and nab-paclitaxel. Gemcitabine and nab-paclitaxel is an~     FDA-approved regimen to treat pancreatic cancer. Secondary goals will be to find out the~     effect on tumor of this new drug combination of BYL719, gemcitabine and nab-paclitaxel. In~     the first part of the study, different doses of BYL719 will be tested. In the second part of~     the study, all patients will be started at the same dose of BYL719.~   "
107902|NCT02155075|"~     Three-dimensional functional Metabolic Imaging (3D MIRA) is a new infrared imaging technology~     using the Real Imager 8 (RI8) developed by Real Imaging. This technology generates 3D~     metabolic maps of the breast and based on sophisticated machine learning technology, provides~     objective risk assessment for the presence of malignant tumor in the breast. The procedure is~     non-invasive, comfortable and does not involve ionizing radiation. It is based on acquiring~     infrared images of the breast. Those images are processed and analyzed by computers to~     provide the objective risk assessment.~      The technology is intended to be used as a screening tool for breast cancer and emerges as~     highly useful in women for whom screening mammography is sub-optimal, such as women with~     dense breast. 3D MIRA is unaffected by breast density and is therefore ideal for evaluating~     patients with mammographically dense breasts.~      The purpose of this clinical study is to assess the ability of this novel technology to~     detect breast cancer in women.~   "
107935|NCT02154646|"~     The main purpose of this study is to evaluate the safety and side effects of LY2157299 in~     combination with gemcitabine in Japanese participants with pancreatic cancer that is advanced~     or has spread to another part of the body.~   "
107903|NCT02155062|"~     Alkylresorcinols (AR) are a group of lipids found in the bran fraction of wheat and rye~     grains. AR are absorbed into the bloodstream and their metabolites are excreted in urine in~     measurable amounts following ingestion of wholegrain (WG) wheat or rye cereal. As AR are~     absent in refined cereals, plasma AR and urinary AR metabolites are proposed as suitable~     biomarkers of dietary intake of WG wheat and rye cereal, with a number of studies supporting~     this proposal. Different AR species are present in characteristic quantities in WG wheat in~     comparison to WG rye cereals, which can allow identification of the main source of WG (wheat~     or rye) in individuals by analysing the AR concentrations in blood. However the patterns of~     urinary AR metabolite excretion following wheat or rye intake have not yet been investigated~     to determine if there are differences according to WG source.~      The present study aims to:~      (i) investigate the differences in AR metabolite excretion pattern in spot and 24 hour urine~     samples after following a predominantly WG rye-based diet in comparison to a predominantly WG~     wheat-based diet and in comparison to control (refined cereal diet) (ii) compare the validity~     and reproducibility of AR metabolites in spot urine samples in comparison to 24 hour urine~     samples.~   "
107904|NCT02155049|"~     Prostaglandin analogues eye drops are common and effective treatment for decreasing~     Intra-Ocular Pressure (IOP) in Glaucoma patients. A number of recently published case reports~     have documented periorbital fat atrophy following treatment by prostaglandin analogues. In~     this study the investigators want to use this side-effect of prostaglandin analogues for the~     treatment of orbital and periocular fat proliferation in inactive Thyroid eye disease (TED)~     patients, as a conservative substitute for surgical intervention.~   "
107905|NCT02155036|"~     The proposed research aims to examine whether regular aerobic exercise can preserve renal~     function, improve aerobic capacity, physical and psychosocial function, strength,~     cardiovascular function, general well-being and quality of life. Ultimately, the research~     aims to prove that exercise is a more cost-effective and a more efficient use or healthcare~     resources used in the treatment of patients with CKD. Exercise is a relatively cheap~     treatment option which is readily available and accessible for this patient population.~     establish if, compared with usual care, an exercise programme for pre-dialysis CKD patients;~        1. Preserves renal function.~        2. Improves aerobic capacity, physical and psychosocial function, strength, cardiovascular~          function, general well-being and quality of life.~   "
107906|NCT02155023|"~     Two new glucose sensors (IR-Glucose Reader (Joanneum Research, Austria), IR-CGM (IMM,~     Germany)) will be investigated to determine the optimal calibration method in patients with~     type 1 diabetes~   "
107907|NCT02155010|"~     Patients were randomized into two groups, A group and B group. A group and B group patients~     are injected intravenous dexmedetomidine after intrathecal injection (IT) of heavy~     bupivacaine and injected intravenous dexmedetomidine before IT of heavy bupivacaine,~     respectively.~      The investigators will compare of hemodynamics and patient's comfortability between two~     groups.~   "
107908|NCT02154997|"~     During pregnancy nutrition demands change and the pregnant woman needs to adjust her food~     intake and take into consideration the corrected daily recommendations for micro and macro~     nutrients. Pregnant woman tend to suffer from hyperemesis and this affects their food choice.~      Amongst pregnant women with Diabetes the glucose balance is extremely important during~     pregnancy. Glucose balance is a result of correct nutrition and an exact amount of insulin.~     This delicate balance requires from the pregnant women an ability to perform correct~     carbohydrate count.~      Hyperglycemia has already been proven to affect the fetus and the neonatal outcomes.~     Hypoglycemia may also have a negative effect but the main danger is immediate harm to the~     mother and therefore to the fetus. For those reasons glucose balance is crucial and demands~     delicate synchronization of nutrition and insulin therapy.~   "
107909|NCT02154984|"~     The purpose of this study is to study the relationships between obesity, hormones and~     menopausal status, and breast cancer. The researchers would like to study whether a type of~     nutritional intervention, called a time-restricted diet or tRD, is easy to maintain using a~     smartphone application; the researchers also want to study the effect that a tRD has on~     weight control, hormones, and breast tissue. A tRD is a type of diet that requires people to~     restrict their daily eating to a specific time frame each day. The researchers think that~     this might be an effective and manageable way to control weight.~   "
107910|NCT02154971|"~     The ageing process is known to be accelerated in HIV-infected patients, compared to the~     general population.~      Normal age-related hearing loss (presbyacusia) is a frequent phenomenon, affecting more than~     70% of people above 65 years. It is believed to be mostly the consequence of a mitochondrial~     damage caused by oxidative stress.~      Risk factors for accelerated age-related hearing loss are present in many HIV-infected~     patients : chronic inflammation, smoking, diabetes, etc.~      The global aim is to measure the prevalence of presbyacusia in a well controlled HIV positive~     population in France, and to compare it to HIV negative controls matched for age and sex.~      90 HIV positive patients and 90 age- and sex- matched HIV negative controls will undergo a~     screening for presbyacusia (pure-tone, speech and evoked-response audiometry).~      We expect to find an increased prevalence of presbyacusia in HIV-infected patients, as~     compared to controls matched for age and sex.~   "
107911|NCT02154958|"~     300 women with unexplained infertility who are already decided to be treated with ICSI will~     be recruited from Cairo university hospitals and Dar Al-Teb subfertility centre.~      On the second day of menstruation serum FSH, LH, Prolactin and Oestradiol will be assessed~     and the antral follicular count (AFC) will be assessed using a vaginal ultrasound scan. AFC~     will be defined as the number of follicles measuring 3-10mm.~      All patients will have standard pituitary down-regulation followed by (Human menopausal~     gonadotrophin (HMG) stimulation until the day of (Human chorionic gonadotrophin (HCG)~     administration. On the day of HCG administration, ovarian ultrasound scan will be performed~     using a transvaginal probe and the Preovulatory follicle count (PC) will be assessed, (PFC)~     is defined as number of follicles measuring≥16mm. FORT will be calculated as: (PFC) *~     100/AFC.~   "
107912|NCT02154945|"~     Purpose:~      Primary: to prospectively measure Retinal Nerve Fiber Layer (RNFL) and macular thickness~     changes during pregnancy by Optical coherence tomography~      Secondary: The effect of pregnancy abnormalities on RNFL and macular thickness in~     participants who develop systemic or ocular complications during the study period.~   "
107975|NCT02154113|"~     The purpose of this study is to compare the clinical performance of the Ultrashape system~     with VelaShape II device for reduction of the waist.~   "
107913|NCT02154932|"~     Introduction: The study aimed to investigate the effectiveness of a single versus double dose~     of Prostaglandin E2 Misoprostol, 400 microgram during myomectomy for multiple uterine~     fibroids. This was a prospective randomized controlled trial comprised of 69 patients with~     multiple myomas undergoing myomectomy. Patients randomly allocated to either an intra-vaginal~     single dose of 400 microgram Misoprostol 1 hour pre-operatively (group A, 34 cases) or 2~     doses, 3 and 1 hours, prior surgery (group B, 35 cases). Operation time, intra and~     post-operative blood loss, hemoglobin concentration, blood pressure and body's temperature~     were estimated and compared in both groups.~   "
107914|NCT02154919|"~     To compare the different effect of conservative pharmacotherapy and Staged Percutaneous~     Coronary Intervention (SPCI) on significant non-culprit lesions in patients with ST-segment~     elevation myocardial infarction (STEMI) at presentation remains controversial~   "
107915|NCT02154906|"~     Inflammatory periodontal disease often results in loss of bone around the teeth. Bone defects~     that have a certain size and shape (called intrabony or intraosseous defects) may be improved~     by using a graft material in the bony defect. The purpose of this study is to compare healing~     of periodontal intrabony defects that are treated using demineralized freeze dried bone~     allograft (DFDBA) versus autogenous platelet-rich fibrin.~      The null hypotheses is that there will be no significant differences in bone fill, CAL gain,~     PD reduction or recession at sites treated with PRF compared to sites treated with DFDBA.~   "
107916|NCT02154893|"~     There are several therapeutic effects of the ultrasound (US) or low level laser therapy~     (LLLT), including pain relief, increase of microcirculation, modulation of inflammatory~     response and accelerated tissue repair. The investigators hypothesis was that a combination~     of US, LLLT and therapeutic exercise may maximize clinical outcome.~   "
107917|NCT02154880|"~     Hypothesis;Aging modifies the risk of pulmonary dysfunction in HIV+ individuals.~      The study is a multicenter, prospective observational study of aging and pulmonary function~     in HIV. The investigator will determine the prevalence and risk factors for lung dysfunction~     as quantified by pulmonary function testing in both younger (<50 years) and older (≥50 years)~     HIV+ and HIV-uninfected controls. The investigator will build on existing cohorts and enrich~     enrollment for individuals over the age of 50 while adjusting for important co-variates such~     as ART, smoking history, co-infections, and illicit drug use. Evaluations will be scheduled~     at baseline, 18 months, and 36 months. Study visits will consist of blood draw,~     questionnaires, and pulmonary function testing.~   "
107918|NCT02154867|"~     Fecal Microbial Transplantation in Treatment of Irritable Bowel Syndrome; a Double Blinded~     Placebo Controlled Trial - the REFIT project~      Irritable bowel syndrome (IBS) is a condition characterized by variable complaints like~     diarrhoea, bloating and abdominal pain, and may result in considerably reduced quality of~     life and increased sickness absence. The prevalence of IBS in the general population may be~     as high as 15 per cent depending on the diagnostic criteria used. The pathophysiology of IBS~     is poorly understood and theories of visceral hypersensitivity, micro-inflammation and other~     less well founded theories have been stated. So far, no measurement or test can affirm~     diagnosis, but exclusion of organic diseases in combination with a typical symptom pattern~     according to the Rome classification can set the diagnosis.~      Earlier non-controlled case reports have shown a convincing effect of fecal microbial~     transplantation (FMT) in IBS patients. However, no placebo controlled trial has been~     performed in this condition. Changes in the gut microbiome may be an important factor in IBS~     pathogenesis. Microbiome analysis has revealed changes in microbiome composition that may~     trigger changes in visceral sensibility and pain perception.~      The fecal microbial transplantation (FMT) procedure has been used primarily to treat~     clostridium difficile infections. Few minor side effects have been reported.~      Hypothesis: IBS is caused by an imbalance of the gut microbiome that may be reset by~     transplanting a microbiome sample from a healthy donor.~      Aim of study:~        -  To test the clinical effect of FMT in patients with IBS~        -  To describe the fecal microbiome in IBS patients~        -  To describe changes in the fecal microbiome of IBS patients following FMT~      The REFIT study will perform a randomized placebo-controlled double blinded trial of FMT on~     IBS according to the Rome 3 criteria. A study group of 60 IBS (diarrhoea variant) patients~     will recruited from general practice and allocated to active (30) or placebo (30) by block~     randomization. Donors will be 15 healthy volunteers with no risk behaviour and a~     pre-screening for communicable diseases will be performed.~      Outcome measures will be clinical assessment by IBS-severity scoring system (IBS-SSS) at 0,~     1, 3, 6, and 12 months. Microbiome analysis will be performed by metagenomic sequencing~     (University of Tromsø) at 0, 3, and 12 months for patients, and at inclusion for donors.~   "
107919|NCT02154854|"~     The purpose of this study is to compare parallel-group effects between 4 months and 12 months~     post-transplantation 2 values of target residual concentrations of Advagraf on vascular~     parameters in de novo renal transplant patients.~   "
107920|NCT02154841|"~     It is well known that patients who have undergone major surgical procedures are vulnerable to~     the consequences of inadequate calorie or nutritional intake. Clinical studies have~     demonstrated that early post-operative feeding increases strength and healing of an~     intestinal anastomosis, reduces surgical site infection and length of hospital stay. The~     'Enhanced recovery programme', ERP, includes early post-operative nutrition as one of its key~     goals, however there is no guidance on the type of food that should be offered to patients in~     this programme. Anecdotally, many patients and healthcare professionals believe that there~     are differences in how food tastes to early post-operative patients. If there are changes in~     taste following surgery this will affect the food choices that patients make in the early~     post-operative period. No studies have addressed this question to date. In this study we hope~     to describe this affect and consider the significance of any changes on the background of~     current hospital food options.~      We hypothesise that food preference and tastes and desires are altered in the early post~     operative period and this affects what patients eat at this critical time.~   "
107921|NCT02154828|"~     The research project is part of the evaluation of the therapeutic approaches in mental~     health. Its framework infant and juvenile units that have developed integrative devices,~     taking into account recent advances in knowledge and providing care, education and~     pedagogical approach. The evolution of autistic children receiving these integrative devices~     is studied to determine the validity of the devices mentioned. The methodology is based on~     case studies in a natural situation. Clinicians are committed to network among themselves and~     with researchers in a multicenter study.~   "
107922|NCT02154815|"~     The main objective is to assess the psychological impact of pre-emptive kidney~     transplantation on patients' quality of life taking into account psychological adjustment~     (response shift), compared to patients who have experienced a short pre-transplant dialysis~     period of less than 36 months.~   "
107944|NCT02154529|"~     Evaluate the safety and tolerability and determine the maximum tolerated dose (MTD) of the~     combination of tesevatinib and trastuzumab in subjects with HER2-positive metastatic breast~     cancer~   "
107945|NCT02154516|"~     The purpose of this study is to assess the early and long term safety and efficacy of the~     hard-on-hard total hip replacement system (R3 ODH-ODH utilization) in patients with~     non-inflammatory arthritis.~   "
107923|NCT02154802|"~     Because people with undiagnosed HIV will not receive treatment and may unknowingly infect~     others, the investigators propose a mobile computer-based video intervention to increase HIV~     test rates in high volume urban hospital emergency departments (EDs). EDs offer important~     points of contact for many of those at greatest risk for HIV. Unfortunately, when ED patients~     are offered routine HIV testing, most decline. Our proposed intervention builds upon initial~     findings from a trial our research team conducted with patients who declined HIV testing. The~     intervention, grounded in the Information-Motivation and Behavioral Skills model (IMB),~     showed an onscreen physician explaining the importance of HIV testing (to build knowledge and~     motivation) and modeling a rapid HIV test (to increase motivation and behavioral skill). This~     brief intervention had a potent effect: a third accepted HIV testing post-intervention. While~     this preliminary study is highly encouraging, it revealed a number of other critical research~     questions. First, it remains unclear what intervention component most strongly contributed to~     patients' decisions to test: the video content or the offer of an HIV test by a computer~     rather than a person. Second, consistent with the literature, participants indicated a~     community member disclosing positive HIV status onscreen would increase the proportion of~     patients who test. Third, results suggest there is individual variation in the extent to~     which behavior is more strongly influenced by onscreen community members or experts (e.g.~     physicians). Therefore, the goal of the present study, guided by the IMB model, is to~     determine how the investigators can refine mobile computer-based interventions to maximize~     HIV testing rates among patients who initially decline to test in the ED. At the end of the~     computerized intervention, onscreen text will ask patients if they would agree to an HIV~     test. Those who agree will be tested by ED staff. The study's endpoint will be~     post-intervention HIV test rates. The investigators' study will inform scalable interventions~     for underserved populations nationwide.~   "
107924|NCT02154789|"~     Digital myxoid cysts arise from degeneration in the connective tissue of the digit joint,~     usually the last joint of the finger or toe, often due to underlying joint arthritis. They~     may connect with the joint. Pressure from the cyst can result in deformity of the digit's~     nail and trauma to the cyst results in leakage of the fluid, representing a potential source~     of entry for infection. Cysts can be tender and interfere with the digit's function. A~     variety of treatments are available, from simple extrusion which is rarely successful, to~     more destructive cryotherapy, infra-red coagulation and formal excision under local~     anaesthetic. These latter three approaches can result in considerable scarring. Sclerosant~     injection of polidocanol in one small non-randomised trial has been reported to be a well~     tolerated efficacious treatment with minimal scarring and long-term resolution. Following a~     pilot study, the investigators aim to trial this treatment to assess efficacy in a larger~     population.~   "
107925|NCT02154776|"~     This is a multi-center, open-label, non-randomized, phase I study~   "
107926|NCT02154763|"~     This is a pilot study in a randomized, controlled, double-blinded format and will evaluate~     the ability of a local anesthetic, Ropivacaine, to decrease pain after gastric bypass~     surgery. The drug will be administered into the abdomen during a bariatric bypass surgery.~     After surgery, patients who received Ropivacaine will be compared to those without~     Ropivacaine to determine its effect on reducing pain, recovery of lung function, ability to~     walk, and quality of life during recovery.~   "
107927|NCT02154750|"~     This is a randomized, prospective clinical trial to determine the effects of two different~     pacemaker atrioventricular delay (AV delay) settings on heart function in patients with dual~     chamber pacemakers implanted for symptomatic bradycardia with long PR intervals (delayed~     conduction between upper and lower chambers of the heart). The study will compare a long,~     fixed AV delay (standard) with an optimized AV delay for each individual using~     echocardiography (experimental).~   "
107928|NCT02154737|"~     The purpose of this study is to see whether an altered schedule of giving erlotinib in~     combination with gemcitabine will be safe and might improve the results of the treatment for~     advanced cancer of the pancreas.~      Gemcitabine and erlotinib are commercially available. Gemcitabine is FDA approved as~     first-line treatment for patients with locally advanced, unresectable or metastatic cancer of~     the pancreas. Erlotinib is FDA approved in combination with gemcitabine for the first-line~     treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.~      The FDA recommended dose for erlotinib is 100 mg daily. This study will investigate the~     experimental administration of higher doses of erlotinib given for only three days twice a~     month, a schedule called pulse dosing.~   "
107929|NCT02154724|"~     Despite its therapeutic effectiveness in Parkinson's disease (PD) the current deep brain~     stimulation (DBS) strategy could achieve an even better clinical result by adapting to~     patient's condition. As intracerebral activity analyzed by recording local field potentials~     (LFPs) from DBS electrodes correlates to PD symptoms, a new stimulation approach would be an~     intelligent adaptive DBS system able to change stimulation settings automatically to the~     patient's needs using LFPs as control variable.~   "
107930|NCT02154711|"~     The purpose of the study is to use a new research imaging technique, a kind of magnetic~     resonance imaging (MRI), to measure important metabolic features of muscle, including~     mitochondrial function, in people with mitochondrial disease and in healthy individuals.~     (Mitochondria are tiny organelles that generate energy for the body.)~      It is hoped that this new strategy will help physicians to understand better the health~     problems of people with mitochondrial disease. Eventually, this could lead to better~     diagnostic and treatment approaches.~   "
107931|NCT02154698|"~     The purpose of this study is to compare the usefulness of two needles (used for obtaining a~     lung tissue sample : (1) standard 22-gauge, and (2) ProCore 22-gauge) for endobronchial~     ultrasound~   "
107932|NCT02154685|"~     Smoking occurs in approximately 21% of the US population, is responsible for an annual~     mortality rate of approximately 438,000 citizens, and has an associated healthcare economic~     burden of $167 billion. Although pharmacotherapies have improved cessation outcome, the vast~     majority of individuals making quit attempts relapse within 5-10 days of cessation. The~     hypotheses to be examined in this study may have potentially important implications for~     smoking cessation treatment and will, therefore, target the single greatest addiction-related~     cause of morbidity and mortality.This study will investigate a novel behavioral strategy for~     altering important memory processes that underlie human smoking-related nicotine addiction.~     This strategy used in this study employs established cue exposure procedures to putatively~     update smoking-related memory with information that will suppress responding to smoking cues.~     The goal here is to alter existing nicotine-related memory directly rather than rely~     exclusively on the establishment of an inhibitory extinction process, via traditional cue~     exposure therapy, which is known to be vulnerable to spontaneous recovery, renewal and~     reinstatement. Positive findings would represent a significant advance in exposure-based~     therapy for addiction and could lead to a treatment that uniquely targets the problem of~     cue-elicited craving and reactivity, thereby addressing a major obstacle to successful~     smoking cessation.~   "
107936|NCT02154633|"~     Mutations in the BRCA1/2 genes are the primary cause of hereditary breast/ovarian cancer~     syndrome. Genetic testing identifies mutation carriers and enables them to manage their~     cancer risk (i.e. chemoprevention, risk-reducing surgery, or intensive surveillance).~     However, uptake of genetic testing among at-risk individuals is low, implying that~     information about the disease and genetic testing is not being communicated effectively among~     family members. Mutation carriers are distressed about disclosing test results, while their~     relatives do not understand the implications of a positive test result for their own health.~     Thus, interventions that support family communication about genetic risk, and address~     psychological distress of family members could contribute to more effective management of~     hereditary breast/ovarian cancer.~      The project aims to develop a family communication and decision-support intervention to 1)~     increase family communication about BRCA1/2 mutations; 2) reduce psychological distress~     associated with these mutations; and 3) increase informed decision-making regarding uptake of~     BRCA1/2 testing among at-risk family members. Focus groups with mutation carriers and at-risk~     relatives will inform the refinement of the intervention, as well as timing and mode of~     delivery. Two group, pre-post test study with a new sample of mutation carriers and family~     members will be used to test the feasibility, acceptability, and effect of the intervention.~   "
107937|NCT02154620|"~     Distal radius fractures with dorsal dislocation among patients 70 years or older are~     randomized to conservative treatment with plaster or internal fixation with a volar plate.~     Thereafter they are followed at 2 weeks, 5 weeks, 3 months and 12 months with x-ray,~     functional scores and clinical examination.~   "
107938|NCT02154607|"~     Oral Lichen Planus (OLP) is a common condition with its erosive variant occasionally~     presenting a management challenge to the clinician. In addition it can have debilitating~     consequences on the patients' quality of life. The malignant transformation of OLP has been~     well documented. The aims of this work were to measure the number of patients developing~     malignant transformationof OLP to squamous cell carcinoma (SCC) comparing patients undergoing~     traditional symptomatic treatments with those patients that were treated by CO2 laser from~     2004 - 2011. Outcome measures were rated by incisional biopsy (histology Report).~   "
107939|NCT02154594|"~     To study effect of acacia catechu a herbal extract;as antipaque and antigingivitis agent in~     patients with fixed orthodontic appliances.This study is a double blind randomized controlled~     trial.~   "
107940|NCT02154581|"~     In this study a tooth that needs to be extracted will be replaced by an implant (artificial~     root) placed at the same appointment as the extraction. The investigators want to observe how~     the gums change shape with healing in two different scenarios:~        1. If the soft tissue around your tooth is thin, following extraction and implant placement~          an extra soft tissue graft (taken from your palate) in the area in order to increase the~          thickness of your gums after healing.~        2. If the soft tissue around your tooth is thick, the implant will be placed without a soft~          tissue graft.~      Previous studies have shown that both methods work and can give good results. In fact the two~     methods are used routinely but they have never been compared objectively to one another in~     the same research study.~      The main purpose of this study is to evaluate if there is any difference in terms of esthetic~     outcomes between these two treatment modalities after a crown has been placed on the implant.~   "
107941|NCT02154568|"~     Computer simulations are being developed to predict air flow abnormalities in the airways of~     patients with lung disease. The purpose of this study is to obtain actual gas flow~     measurements in the lungs of healthy patients and patients with lung disease and use these~     measurements to validate the computer models.~   "
107942|NCT02154555|"~     Chronic rhinosinusitis (CRS) is a common sinus and nasal condition affecting more than 33~     million Americans. The treatment of CRS typically begins with maximal medical therapy~     however, when this fails to improve patient symptoms, surgical intervention is considered.~     Endoscopic sinus surgery (ESS) is a well-established treatment for refractory CRS with~     approximately 600,000 sinus surgeries performed annually in the United States alone. Despite~     the success of this intervention, up to 26% of patients experience complications following~     surgery, including middle meatal (MM) synechiae, edema, polyp recurrence, and middle~     turbinate lateralization. Currently, there is no consensus as to the postoperative care~     regime that is most effective at minimizing or preventing these potential complications.~     Therefore there is need for further study into the role of debridement, examining patients~     undergoing endoscopic sinus surgery while concurrently addressing the potential confounders~     of maximal medical therapies in the postoperative setting.~      This prospective, randomized, single-blind, controlled study design will investigate the~     efficacy of postoperative debridement following ESS. Patients who have undergone ESS will~     have one nare randomized to debridement and the other to no debridement at the first week~     post-operative visit. In this way, the patients will act as their own controls in order to~     account for inter-patient variability in disease severity. The primary outcome will assess~     synechiae formation attributed to ESS. Secondary outcomes will include pain (side-specific)~     attributed to the debridement procedure as well as comparing pre and post endoscopy scores~     and SNOT-22 questionnaire responses.~   "
107943|NCT02154542|"~     Mechanical ventilation is a vital therapeutic support, widely used in pediatric intensive~     care. Invasive ventilation (IV) is associated with risk of major complications ( nosocomial~     pneumonia, secondary pulmonary barotrauma injuries, pneumothorax) , which can increase : the~     duration of ventilation, mortality, length of ICU stay and health costs. The practitioner~     should ask the benefit of the continuation of this IV daily and adapting it, to limit~     complications. The evaluation of the work of breathing is a key element in understanding the~     pathophysiology of respiratory distress but is also a key element in improving the management~     of ventilatory support and the adjustment of ventilatory parameters .~      It has been shown that there is an increased work of breathing in all children admitted in~     ICU for clinical acute respiratory distress that is significantly reduced by ventilatory~     support. There is probably a relationship that should be proportional between the work of~     breathing ( PTP ) resulting in respiratory request triggered by the respiratory drive and the~     electrical activity of the diaphragm ( Edi ) .~      The validation of this correlation PTP / Edi has a direct impact on the monitoring of~     ventilated patients with the ability to monitor the physiological factor while maintaining a~     classical treatment of children by simply monitoring Edi without additional invasive device .~   "
107946|NCT02154503|"~     Androgenetic Alopecia is the most common non scarring alopecia worldwide. Treatment of which~     has been limited with few options for medical and surgical treatment, the cost of the latter~     being prohibitive for many. Recently there have been several new modalities proposed as~     treatment, namely Microneedling and Platelet Rich Plasma.~      Microneedling has been shown to overexpress hair growth factors which may enhance or~     stimulate miniaturized hairs to grow. It has also been shown to increase the absorption of~     topical products significantly. The exact mechanism of action of Microneedling is still being~     delineated.~      In this study, we aim to do a half lesional study with global photographs and hair counts~     done at the start of , week four and week twelve. Patients would be needled once weekly after~     application of topical anaesthetic (5% EMLA). If by week six there is significant regrowth~     (>30%), then total lesional needling will be done. Patients will only be using topical 5%~     Minoxidil throughout the study as this will prolong the effects of the regrowth.~   "
107947|NCT02154490|"~     This screening and multi-sub-study randomized phase II/III trial will establish a method for~     genomic screening of similar large cancer populations followed by assigning and accruing~     simultaneously to a multi-sub-study hybrid ?Master Protocol? (S1400). The type of cancer~     trait (biomarker) will determine to which sub-study, within this protocol, a participant will~     be assigned to compare new targeted cancer therapy, designed to block the growth and spread~     of cancer, or combinations to standard of care therapy with the ultimate goal of being able~     to approve new targeted therapies in this setting. In addition, the protocol includes a~     ?non-match? sub-study which will include all screened patients not eligible for any of the~     biomarker-driven sub-studies. This sub-study will compare a non-match therapy to standard of~     care also with the goal of approval.~   "
107948|NCT02154477|"~     Over the last few years, studies have shown that men with type 2 diabetes sometimes develop a~     condition called hypogonadotrophic hypogonadism (HH). People with this condition produce~     little or no sex hormones. Obesity and metabolic syndrome are also associated with HH.~     Research suggests that insulin in the brain may benefit the glands that release these~     hormones. During this study, subjects will spray a small amount of insulin into their~     nose.This will increase insulin concentrations in the brain. The purpose of this study is to~     find out the effect of one dose of intranasal insulin on release of LH (a sex hormone) in~     obese diabetic men with HH.~   "
107949|NCT02154464|"~     The investigators predict that giving patients paracetamol in the operative period will~     reduce their need for opioid pain reducers in the post operative setting.~   "
107950|NCT02154451|"~     The hypothesis or study goal is to determine whether functional dynamic infrared imaging can~     be used for melanoma and other skin cancer screening and/or diagnosis.~   "
107951|NCT02154438|"~     The purpose of this study is to evaluate the effect of ketamine infusion for reduction of~     neuropathic pain and improvement of quality of life after lumbar surgery.~   "
107952|NCT02154425|"~     The primary objectives of this study are to assess whether there is transfer of Certolizumab~     Pegol (CZP) into breast milk of lactating mothers who are receiving an established dosing~     regimen of CZP by evaluating the concentration of CZP in mature breast milk, and to calculate~     the daily infant dose of maternal CZP.~   "
107953|NCT02154412|"~     This clinical study is designed to investigate the mechanisms of blood pressure regulation~     and respiratory motor function affected by spinal cord injury (SCI). We hypothesize that~     impaired blood pressure regulation in individuals with chronic SCI can be improved by~     restoring respiratory motor function by using Respiratory Motor Training (RMT).~   "
107954|NCT02154399|"~     This pilot phase II trial studies how well EF5 works in measuring lack of tumor oxygen,~     hypoxia, in patients with stage I-III non-small cell lung cancer. EF5 may be effective in~     measuring the lack of oxygen in lung tumors and may allow doctors to plan better treatment.~   "
107955|NCT02154386|"~     Bone grafting following tooth extraction is commonly performed to preserve bony ridge~     dimensions adequate to support subsequent implant placement. Alveolar ridge resorption~     commonly occurs following tooth extraction, and the decrease in bone volume has the potential~     to make dental implant therapy impossible without surgery to reconstruct the ridge. The aim~     of ridge preservation grafting is to prevent or minimize this resorptive process, thereby~     preserving an adequate volume of bone for implant placement. Ridge preservation generally~     involves placement of a particulate bone graft material in the tooth socket, followed by use~     of a membrane or similar substance over the socket entrance to contain the bone graft.~     Various grafting materials have been recommended for these ridge preservation procedures,~     including demineralized freeze-dried bone allograft (DFDBA). The timing of dental implant~     placement following ridge preservation procedures is controversial, and few studies have~     examined the effects of different healing time intervals between ridge preservation and~     implant placement. The purpose of this project is to evaluate the formation of new bone at a~     site where tooth extraction has been performed followed by grafting using DFDBA. Two~     different study groups are included, one having the dental implant placed 8-10 weeks after~     tooth extraction and ridge grafting, the other having the dental implant placed 18-20 weeks~     after extraction and grafting.~   "
107956|NCT02154360|"~     This is an open-label, single arm, phase I study to determine the safety, PK characteristics~     and anti-inflammatory effects of the NK-R1 coadministered with ritonavir-containing~     antiretroviral therapy in individuals with well-controlled viral replication.~      Our hypothesis is that Aprepitant will be safe, well tolerated, and will have~     anti-inflammatory properties when administered concomitantly with the protease inhibitor~     ritonavir.~   "
107957|NCT02154347|"~     The purpose of this study is to evaluate the long-term safety and efficacy of KAD-1229 as~     combination therapy with insulin in patients with type 2 Diabetes Mellitus who show~     inadequate glycemic control with diet, and insulin monotherapy, or insulin and oral~     hypoglycemic agent.~   "
107958|NCT02154334|"~     The purpose of this study is to evaluate the effects of allergic rhinitis (group of symptoms~     affecting the nose) and co-administration of mometasone or oxymetazoline on the~     pharmacokinetics (explores what the body does to the drug), safety, and tolerability of~     intranasal (administered through the nose) esketamine.~   "
107961|NCT02154295|"~     The purpose of this study is to investigate and compare the images obtained from coronary~     imaging catheters used in the treatment of coronary blockages both in a clinical setting with~     patients and in models.~   "
107962|NCT02154282|"~     To see if using ipod games can improve mental functioning~   "
107964|NCT02154256|"~     This study will be a three-arm randomized, controlled trial that the investigators will run~     in 2014 with approximately 4,000 users of an app called Achievemint. AchieveMint rewards~     users with points (which can be redeemed for prizes) for every step they take. The~     investigators will be testing three different point-based programs designed to encourage~     users to build exercise habits over the course of a month: stable incentives, increasing~     incentives, and decreasing incentives. After the investigators' month-long intervention~     period, the investigators will observe users' step counts during a month-long follow-up~     period to test which of the investigators' habit-building programs leaves users with the best~     exercise habits (or the highest step counts) after they conclude.~      The time frame of observation will be 8 months.~   "
107965|NCT02154243|"~     Orthostatic hypotension following total hip arthroplasty is known to limit the ability of~     patients to perform physical therapy (PT) and increase the length of hospital stay and costs.~     Our goal is to prospectively study the effects of oral midodrine on the signs and symptoms of~     orthostatic hypotension in 20 patients and the effects of intravenous fluid on the signs of~     symptoms of orthostatic hypotension in 10 patients. Midodrine will be administered to~     patients with suspected low SVV, and an intravenous fluid bolus will be administered to~     patients with low CO. 120 patients will be consented with a view to studying 30 patients who~     meet the inclusion criteria for orthostatic hypotension. Patients who receive midodrine or~     the fluid bolus will undergo hemodynamic measurements at 30 min, 1 hr, 2 hrs, 3 hrs, and 4~     hrs post-intervention. All patients will undergo measurements for blood pressure, arterial~     augmentation index, and heart rate at baseline (pre-op; holding area) and the time of first~     PT attempt. Patients will be monitored up to post-operative day 3. The working hypothesis is~     that midodrine or fluid therapy will significantly raise the mean arterial blood pressure~     (MAP) by 5 mmHg+ and/or cause a significant change in the Orthostatic Hypotension~     Questionnaire (characterized by a two-point improvement in symptom score).~   "
107966|NCT02154230|"~     Overweight and obese patients will be recruited and randomly assigned to two groups of~     intervention. To the first group [sulphate-bicarbonate-calcium water and low-calorie diet~     (SW-D)] will be administered Acqua Santa di Chianciano®, associated to a personalized low~     calorie diet, while the second group [tap water and low-calorie diet (TW-D)] will follow the~     personalized low calorie diet but will be asked to drink the same quantity of tap water, over~     a 4 week period. Stool samples will be collected and analyzed for changes in gut microbiota~     composition. Patients' body weight will be recorded at the beginning and at the end of the~     study.~   "
107967|NCT02154217|"~     This is a data revision with a focus on 24 hour perfusion pressures of data from a previous~     randomized, double masked, multicenter clinical trial.~      The aim was to compare the effect of bimatoprost and the fixed combination of latanoprost and~     timolol (LTFC) on 24-hour mean intraocular pressure (IOP) after patients are switched from a~     nonfixed combination of latanoprost and timolol.~      The main findings of the original trial had been published on Ophthalmology [2007;114:~     2244-2251].~   "
107968|NCT02154204|"~     The aim of this study is to examine the use of Near Infrared Fluorescence imaging on~     lymphatic vessels in humans.~      Different parameters that reflect lymphatic function will be tested for intra and inter~     individual reproducibility.~      We use 10 healthy test subjects and examine their lymphatic system. All subjects are healthy~     men between the ages of 20 and 30.~      When the fluorescent dye indocyanine green, has been injected into the skin on the patients~     feet, it will be transported through the lymph vessels, resulting in clear visualization of~     the vessels, using a laser and a EM-CCD camera.~      On both legs we examine the frequency of vessel contraction and the velocity of lymph moving~     in vessels. We furthermore use several methods to quantify the vessel function such as the~     refill time of a vessel, (manually emptied vessel and refill time of 10 cm of a vessel), and~     pumping pressure (at what pressure lymph can pass a blood pressure cuff).~      We investigate the activity of vessels over time, and after several interventions such as~     exercise, and water baths of the foot at different temperatures.~      The patients are examined for approximately 4 hours and wil be examined again 14 days later.~   "
107969|NCT02154191|"~     The purpose of the proposed research is to explore the relationship between objectively~     measured physical activity and surgical intervention for lumbar spinal stenosis (LSS). Our~     primary hypothesis is that post-surgery, LSS patients will demonstrate increased physical~     activity compared to their baseline assessment. A non-intervention control group will be~     measured at the same time intervals as the surgical group to look at test re-test~     reliability. In the event that our hypothesis is rejected, and surgery does not lead to a~     decrease in sedentary behaviour analysis of questionnaire-based sedentary behaviour measures~     and objective activity-based measurement can examine the relationship between self-report and~     actual performance-based objective measures. The primary objective of our proposal is to~     determine if surgical intervention leads to increased activity, and decreased sedentary~     behaviour. The findings of the proposed research will inform healthcare stakeholders that if~     surgery alone does not lead to increased activity, a more concerted research effort may need~     to be made for post-surgical rehabilitation, lifestyle and physical activity counselling so~     that post-surgical patients may make changes toward leading more active and productive lives.~   "
107970|NCT02154178|"~     The investigators hypothesized that the use of biomarkers of invasive fungal infections would~     increase the percentage of early discontinuation of empirical antifungal therapy and thus~     reduce the duration of treatment in ICU patients.~   "
107971|NCT02154165|"~     The optimal wavelength for phototherapy for neonatal jaundice remains to be clarified by~     clinical studies. Previous iv vivo studies have shown that turquoise light at wavelength~     about 490 nm is more efficacious than blue light at wavelength 460 nm, which is the golden~     standard in phototherapy treatment today. Though, previous studies used light tubes, today we~     use light emitting diodes (LED'S).~      The overall aim of this study was therefore to compare the efficacy of turquoise LED's versus~     blue LED's for decreasing total serum bilirubin in neonates with gestational age > 33 weeks~     and uncomplicated hyperbilirubinemia.~   "
107972|NCT02154152|"~     Homeopathic Medicine Causticum 200c will be prescribed in cases of Primary Enuresis on the~     basis of available symptoms for a period of one year and the results will be evaluated at the~     end of the given period and efficacy of the drug will be assessed.~   "
123381|NCT01952522|"~     This study is designed to determine if adding daily weighted braces on the unaffected ankle~     may benefit to patient who have returned home compare to a placebo intervention (ankle brace~     without weight).~   "
107976|NCT02154100|"~     The hypothesis of this study is that the daily consumption of 480 ml tart cherry juice for~     twelve weeks will improve blood pressure and arterial stiffness by improving~     endothelial-mediated vasodilation and vascular sympathetic activity and favorably altering~     biochemical markers associated with cardiovascular risk. 28 men and women between the ages of~     20 and 40 who have three of the five features of metabolic syndrome as defined by the Adult~     Treatment Panel III will be included in the study. After a two-week run-in phase, eligible~     men and women will be randomly assigned to one of two treatment groups: 1) 480 ml tart cherry~     juice or 2) 480 ml control drink daily for twelve weeks. After an initial telephone~     screening, all participants will be requested to report to the study site for their first~     visit. On the first visit (screening), participants will be provided with verbal and written~     explanation of the project. They will then be asked to sign an informed consent form,~     followed by measuring waist circumference, resting brachial blood pressure, fasting serum~     triglycerides, high density lipoprotein cholesterol, and glucose levels to confirm metabolic~     syndrome. Baseline assessments will be performed for medical history, medication use, dietary~     intake, and physical activity. Qualified participants will be scheduled for their second~     visit two weeks later (actual baseline data collection) and randomly assigned to their~     treatment group. On the second (baseline) visit between the hours of 7-10 A.M., blood~     pressure and vascular function will be measured followed by blood draw. Anthropometrics will~     be measured. Participants will be provided with their assigned treatment and will receive~     standard instructions on how to fill out daily diaries for their treatment, and for food and~     physical activity records. Blood pressure, vascular function, blood draw, and anthropometric,~     body composition, diet, and physical activity assessments will be repeated at 6- (third~     visit), and 12-week (final visit) intervals. All cardiovascular measurements will be~     performed between 7:00 to 10:00 A.M., in a quiet temperature-controlled room in the supine~     position after an overnight fast and 12 hours after the abstinence of caffeine and/or 24~     hours after the last bout of moderate to heavy physical activity.~   "
107977|NCT02154087|"~     Assess the influence of HP802-247 on biochemical and cellular markers of inflammation in~     chronic venous leg ulcers~   "
107978|NCT02154074|"~     Dexmedetomidine is a kind of high selectivity alpha 2 agonists adrenaline, can inhibit the~     activity of sympathetic nerve, alleviate pain,and improve cardiovascular stability in the~     operation period. Dexmedetomidine have influence on perioperative stress response and immune~     function,but it is not clear.~   "
107979|NCT02154061|"~     The purpose of the study is to better understand how the use of antibiotics changes~     micro-organisms in the intestines. The change to micro-organisms in the intestines may change~     the body's vaccine immune response and alter the effectiveness of the IIV (seasonal flu)~     vaccine.~      In particular, the investigators will be looking at certain markers in blood after~     vaccination with IIV (seasonal flu vaccine) with or without the use of antibiotics before~     vaccination.~      There will be two randomized groups. Group A will start taking antibiotic by mouth 3 days~     prior to vaccination and continue taking antibiotics the day of vaccination and one day after~     vaccination for a total of 5 days. Group B will only receive the IIV (seasonal flu vaccine)~     and will not take any antibiotics.~      The investigators hope to enroll 50 subjects at Emory.~   "
107980|NCT02154048|"~     The purpose of this study is to determine whether the addition of dexamethasone prolongs~     analgesia when added to long-acting local anesthetic during single-injection supraclavicular~     block for outpatient hand surgery.~   "
107981|NCT02154035|"~     Background:~      Human Immunodeficiency Virus (HIV) is the virus that causes AIDS. HIV can hide in the blood~     for many years, even in people who have their HIV infection under control. HIV that is hiding~     in the blood is called the latent HIV reservoir. Researchers want to find out more about it~     in this study. This knowledge may help them develop new ways to prevent or control HIV. This~     study will draw its participants from the Rakai Health Sciences Program in rural southwestern~     Uganda.~      Objective:~      - To measure and learn about the latent HIV reservoir in Ugandans with HIV.~      Eligibility:~      - Men and women at least 18 years of age with HIV.~      Design:~        -  Participants will have a medical history and physical exam. Their medical records will~          be reviewed. Researchers will ask participants about their health and recent illnesses.~          Participants able to get pregnant will have their urine tested for pregnancy.~        -  Participants will have their finger pricked to see if they have enough red blood cells~          to be eligible for the study.~        -  If eligible, participants will have blood drawn through a needle in the arm. Their blood~          will also be tested for other diseases.~        -  After the blood draw, participants will be asked to stay seated or lying down if they~          are not feeling well for up to 30 minutes.~   "
107982|NCT02154022|"~     Background:~      - Certain drugs - even when they are meant to help people - cause side effects. These are~     unwanted effects of the drug. There are many reasons why a drug might cause side effects in~     one person and not in another. It may be because of how much of the drug is in the person s~     blood at one time. Researchers want to study the blood of people having drug side effects to~     better understand why they happen.~      Objective:~      - To obtain blood samples from patients being treated with an investigational or FDA approved~     drug at the NIH who are having bad side effects that are thought to be due to large amount of~     the drug in their blood. The samples will be used to assess the cause of the side effects.~      Eligibility:~      - People 2 years and older with cancer who are currently enrolled in clinical trials at the~     NIH Intramural Research Program (IRP).~      Design:~        -  Participants will give blood samples.~   "
107983|NCT02154009|"~     Background:~      - The autonomic nervous system helps control things that happen automatically in the body,~     like blood pressure, heart rate, and digestion. When it doesn t work properly, it s called~     dysautonomia. Researchers want to learn more about dysautonomias and train doctors to learn~     how to better diagnose them.~      Objectives:~        -  To allow people with autonomic disorders to be evaluated.~        -  To help fellows in the NIH Autonomic Disorders fellowship program see a variety of~          diseases in their training.~      Eligibility:~        -  People age 18 and older with dysautonomia; children over age 2 if they might benefit~        -  Healthy adult volunteers~      Design:~        -  Participants will have different procedures depending on their symptoms. They will have~          one or more visits. They will have some but not all of the tests below.~        -  Participants will have a medical history and physical exam. They may be tested for~          problems thinking. They may complete a symptom questionnaire. They may have their~          temperature and blood pressure taken.~        -  Participants may have an intravenous line placed. A needle will guide a thin plastic~          tube into an arm vein.~        -  Participants may have blood drawn several times. They may give a urine sample.~        -  Participants may have an electrocardiogram.~        -  How much blood a participant s heart is pumping and/or how much blood is flowing through~          their arm may be measured. The total amount of blood in their bloodstream may be~          measured.~        -  Participants may have their ability to sweat and/or sense of smell tested.~        -  Breathing, bowel sounds, and/or body functions may be monitored.~        -  Pupil size, response to environmental temperature changes, and/or breathing may be~          measured.~        -  Participants may have a bladder ultrasound.~        -  Small pieces of skin may be taken for study.~   "
107997|NCT02153827|"~     The purpose of this study is to examine the effects of eccentric exercise to the shoulder~     muscles for people with shoulder pain. Identifying specific exercise protocols for~     individuals with shoulder pain will provide evidence to help clinicians select the best~     interventions.~   "
107999|NCT02153801|"~     The aim of this study is to compare the incidence of genito-urinary function depression and~     anastomotic leak in Laparoscopic Anterior Rectal Resection (LAR) with Total Mesorectal~     Excision with Ligation if the Inferior Mesenteric Artery at the origin or preserving the Left~     Colic Artery by a prospective randomized trial.~   "
107984|NCT02153996|"~     Plasmodium falciparum malaria is a major cause of morbidity and mortality in tropical and~     sub-tropical areas worldwide. Repeated P. falciparum infections in endemic areas induce~     protective immunity, thus providing optimism that an effective malaria vaccine can be~     developed. Key to the development of such a vaccine is an understanding of the immune~     mechanisms underlying protection and the longevity of these responses in the absence of~     continuous P. falciparum exposure. Anecdotal evidence suggests clinical immunity to malaria~     wanes within months to years after an immune individual leaves an endemic area. A detailed,~     systematic description of the quality and longevity of the P. falciparum-specific humoral and~     cellular immune responses in such individuals over time in the absence of ongoing exposure is~     lacking.~      This protocol will attempt to fill this knowledge gap through comprehensive longitudinal~     immunological analyses of two populations of healthy adult volunteers: 1) naive travelers~     returning from malaria endemic areas recently treated (within 2 weeks) for acute P.~     falciparum malaria and referred from hospitals in the metropolitan Washington DC area; and 2)~     immigrants from malaria endemic areas living in the metropolitan Washington DC area with~     serologic evidence of past P. falciparum exposure. In both groups, venipuncture and possibly~     apheresis will be performed for the isolation of plasma, RNA and peripheral blood mononuclear~     cells (PBMCs) which will be analysed to understand the components of innate and adaptive~     immunity to malaria. Na(SqrRoot) ve travelers returning from malaria endemic areas recently~     treated for acute malaria will undergo venipuncture at enrollment, then once every 2 weeks~     for 2 months, then every 3 months for 1 year, and then every 6 months for up to 5 years.~     Immigrants will be seen every three months for one year and then every six months for up to 5~     years. All subjects who return to the U.S. from a malaria endemic area will be evaluated~     within two weeks of return for repeat venipuncture and will restart the same sequence of~     blood draws as naive travelers. Optional apheresis will be performed on both na(SqrRoot) ve~     travelers and immigrants at enrollment, at 1, 6, and 12 months, then yearly therafter.~      The primary objective is to estimate the quality and longevity of P. falciparum-specific~     humoral and cellular immune responses in the absence of ongoing P. falciparum exposure in~     both returned na(SqrRoot) ve travelers and immigrants. The secondary objective is to compare~     the P. falciparum-specific humoral and cellular immune response in na(SqrRoot) ve travelers~     and immigrants to individuals in malaria-endemic areas enrolled in ongoing LIG protocols in~     Mali.~   "
107985|NCT02153983|"~     Background:~      - Being overweight may cause low-level inflammation. This inflammation may cause some of the~     medical problems of obesity, like high blood sugar (diabetes) and heart disease. This study~     will test whether a medication called colchicine can improve metabolism in adults who are~     overweight but have not yet developed diabetes.~      Objectives:~      - To learn whether colchicine improves sugar regulation and metabolism.~      Eligibility:~      - Healthy overweight adults18 to 100 years old.~      Design:~        -  Participants must fast before each visit, including the screening visit.~        -  Participants will be screened with blood tests,urine tests, medical history, and~          physical exam. They will have to drink sugar water, and have blood drawn to find out if~          they are healthy.~        -  For visit 1, participants will have a medical history and physical exam and answer~          questions. They will have blood taken with an intravenous (IV) line, give urine sample,~          and give 2 stool samples..~        -  Also, subjects will get sugar water through one IV. Blood will be drawn from the other.~          This measures sugar and insulin levels. During this, participants will lie in a bed and~          can watch TV.~        -  Participants will have a full-body X-ray, lying on a table while a camera passes over~          them. They will also have an abdominal CT scan, lying on a table that moves through a~          ring that takes pictures.~        -  Participants will have a small fat tissue sample taken from their abdomen. It is like~          getting a mini-liposuction.~        -  Participants will be given the study drug or placebo. They will take it twice daily for~          3 months.~        -  For visit 2, participants will have blood tests, urine tests, medical history, and~          physical exam.~        -  For visit 3, participants will repeat the tests in visit 1.~   "
107986|NCT02153970|"~     Background:~      - Neuromuscular diseases (NMDs) do not have cures. But future treatments will try to improve~     the health-related quality of life (HRQoL) in people with NMD. Computer questionnaires can~     help test HRQoL in people with NMD. They could help clinicians and researchers know how~     people with NMD and their caregivers are doing. They could also help show if treatments are~     making a difference.~      Researchers want to make sure two of these questionnaires PROMIS (Patient Reported Outcomes~     Measurement Information System) and Neuro-QOL (Quality of Life in Neurological Disorders)~     work the same way every time. They also want to make sure the questionnaires test the same~     things every time.~      Objective:~      - To make sure the PROMIS and Neuro-QOL questionnaires are valid.~      Eligibility:~      - Children age 8 17 who have NMD. Also, caregivers of children age 5 17 who have NMD.~      Design:~        -  Participants will complete the PROMIS and Neuro-QOL questionnaires on a computer. The~          caregiver and child versions are not the same.~        -  Participants will complete the questionnaires at the beginning of the study. It will~          take about 15 20 minutes. They will complete the questionnaires again after 2 4 weeks.~          They may receive phone or email reminders.~        -  Participants will complete the questionnaires at the NIH outpatient clinic and/or on~          their own device. At NIH, they will use a computer or tablet.~   "
107987|NCT02153957|"~     Background:~      - More children with cancer are surviving into adulthood. Some side effects from treatment go~     away quickly. But some problems may not go away or may only show up months or years later.~     These problems are called late effects. Late effects can cause difficulties in cognitive~     functions, such as attention and memory. Physical activity has been found to improve the~     attention and memory skills of children with Attention Deficit Hyperactivity Disorder (ADHD).~     Researchers want to see if physical activity can help with these cognitive problems in~     children with brain tumors.~      Objectives:~      - To see if physical activity can improve cognitive functions in children who had radiation~     therapy for a brain tumor.~      Eligibility:~      - Children ages 8 17 who had radiation for a brain tumor at least 2 years ago. They must have~     access to a computer.~      Design:~        -  Participants will be screened with height, weight, and medical history. They will answer~          questions about daily physical activities. Their heart will be checked.~        -  Participants will go to the clinic for 2 days. They will have a fitness exam and tests~          about attention, memory, and concentration. They will have blood taken and answer~          questions. Parents will also answer questions.~        -  Participants will be put into 2 groups. For the first 12 weeks, the intervention group~          will follow a physical activity program. The control group will do their usual physical~          activities.~        -  For the second 12 weeks, the control group will follow the physical activity program.~          The intervention group will continue the activities on their own. All groups will track~          their physical activity with an activity monitor and computer.~        -  Participants will have a follow-up visit at the clinic after each session. They will~          repeat some of the tests listed above.~        -  The study lasts 24 weeks plus the two follow-up visits. Participants can keep their~          activity monitor.~   "
107988|NCT02153944|"~     Background:~      Stress and anxiety can interfere with how well people perform tasks. But performing a task~     can sometimes lessen anxiety by distracting people from the stress. Researchers want to~     examine the interaction between attention and stress. They will use two drugs with different~     effects on stress and concentration.~      Objective:~      - To better understand how thinking and emotion affect anxiety and performance. Also, to~     study the effects of methylphenidate and propranolol on performance.~      Eligibility:~      - Adults age 18 50.~      Design:~        -  First, participants will be screened with a test in which they hear loud, sudden noises~          through headphones. Sticky pad electrodes will be placed on the skin under one eye.~          These electrodes will tell us how sensitive participants are to the noises.~        -  Second, participants will complete questionnaires about their mood, thinking, and~          anxiety. They will give a saliva sample. For this, a cotton swab will be placed in their~          mouth for 2 minutes.~        -  Third, participants will take a single dose of one of the study pills or a placebo. They~          will then look at words, shapes, and letters on a computer monitor. They will answer~          questions about what they remember. They may receive a shock or hear loud noises during~          the tests.~        -  For the shocks, small metal disk or sticky pad electrodes will be taped to a wrist or~          finger. For recording bodily responses, additional electrodes will be placed on the~          arms, body, and under each eye.~        -  Blood pressure and pulse will be measured during the tests. More saliva samples will be~          taken.~        -  At the end of the study, participants will answer questions about their reaction to the~          study testing and about any effects they noticed from the study pill.~        -  After the experiment, participants will be evaluated for effects of the study pill.~   "
107998|NCT02153814|"~     Infertility affects 1 in 7 couples worldwide. The most successful treatment is in vitro~     fertilization (IVF), a procedure where a woman's eggs are collected and fertilized with sperm~     to make embryos, which are then placed in the woman's uterus using a small catheter, a~     procedure called embryo transfer. Unfortunately, pregnancy rates from IVF are less than~     50%. Recently, several studies have shown dramatically improved pregnancy rates by grazing~     the innermost lining of the uterus (the endometrium) with a small flexible catheter weeks~     prior to embryo transfer. These studies were all performed outside the United States (U.S.)~     in women with multiple failed IVF attempts and did not investigate the mechanisms by which~     endometrial injury works. This study will be the first to evaluate the effect of endometrial~     injury on IVF success in all women undergoing IVF, including first IVF cycles, frozen embryo~     transfers, and donor eggs.~   "
107989|NCT02153931|"~     Background:~      - Studies show that Internet Support Groups (ISGs) can help parents of children with chronic~     conditions. Researchers want to find out if ISGs can help parents of a child with the genetic~     disorder Neurofibromatosis Type 1 (NF1).~      Objective:~      - To see if an ISG for parents with a child with NF1 can give the parents more social support~     and less anxiety.~      Eligibility:~      - Adults age 18 and older with a child (age 0 25 years) with NF1.~      Design:~        -  Participants will register for the study on a website hosted by the Children s Tumor~          Foundation.~        -  Participants will complete 5 questionnaires. These will be about their emotional~          well-being, their child s health status, and their contact information.~        -  The ISG will include a Discussion Forum that participants can enter 24 hours a day, 7~          days a week. A professional moderator will post questions and discussion topics. The~          moderator can also respond to questions. They will be a psychologist, a psychology~          associate, or a nurse-practitioner. Each one will be highly experienced at working with~          young people with NF1 and their families.~        -  The ISG also will contain a chat room. Here participants can chat with other users in~          real time. The chat room will be open for one 90-minute session per week.~        -  The ISG will remain open for 8 weeks. Then participants will retake 4 of the~          questionnaires from the beginning of the study. They will also complete 1 other~          questionnaire about their experiences with the ISG. Information from any messages~          participants post on the ISG website will be collected.~        -  Three months after the ISG closes, participants will complete the questionnaires one~          final time.~   "
107990|NCT02153918|"~     Background:~      - Some men with prostate cancer have their prostate glands removed. The cancer can still come~     back. Researchers want to know if receiving a vaccine before prostate removal surgery can~     lead to less recurrence.~      Objective:~      - To see if a vaccine and booster shots given to men with prostate cancer before surgery~     changes the immune cells in the prostate gland.~      Eligibility:~      - Men age 18 and older who have prostate cancer that has not spread, and who want to have~     their prostate glands removed as treatment.~      Design:~        -  Participants will be screened by their regular cancer care. They may have a small piece~          of prostate removed.~        -  Participants must practice effective birth control before and during the study treatment~          and for 1 month after the last vaccine booster.~        -  Participants will have a medical history, physical exam, and blood and liver tests. They~          will be asked about how they perform daily activities.~        -  Participants will have a magnetic resonance imaging (MRI) scan of the prostate. The~          scanner is a metal cylinder in a strong magnetic field. Participants will lie on a table~          that slides in and out of the scanner.~        -  Participants will be injected with the vaccine, most likely in the leg. They will be~          injected with the vaccine booster 3 times over several weeks.~        -  At each booster visit, participants will have a medical history, physical exam, and~          blood and liver tests.~        -  Participants will have another MRI. Then they will have surgery to remove their~          prostate.~        -  Participants will have 2 follow-up visits during the year after surgery. They will have~          a medical history, physical exam, and blood test.~   "
107991|NCT02153905|"~     Background:~      The NCI Surgery Branch has developed an experimental therapy for treating patients with~     cancer that involves taking white blood cells from the patient, growing them in the~     laboratory in large numbers, genetically modifying these specific cells with a type of virus~     (retrovirus) to attack only the tumor cells, and then giving the cells back to the patient.~     This type of therapy is called gene transfer. In this protocol, we are modifying the patient~     s white blood cells with a retrovirus that has the gene for anti-MAGE-A3 incorporated in the~     retrovirus.~      Objective:~      The purpose of this study is to determine a safe number of these cells to infuse and to see~     if these particular tumor-fighting cells (anti-MAGE A3 cells) cause tumors to shrink and to~     be certain the treatment is safe~      Eligibility:~      - Adults age 18-66 with cancer expressing the MAGE-A3 molecule.~      Design:~        -  Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and~          undergo a history and physical examination, scans, x-rays, lab tests, and other tests as~          needed~        -  Leukapheresis: If the patients meet all of the requirements for the study they will~          undergo leukapheresis to obtain white blood cells to make the anti MAGE-A3 cells.~          {Leukapheresis is a common procedure, which removes only the white blood cells from the~          patient.}~        -  Treatment: Once their cells have grown, the patients will be admitted to the hospital~          for the conditioning chemotherapy, the anti MAGE-A3 cells and aldesleukin. They will~          stay in the hospital for about 4 weeks for the treatment.~      Follow up: Patients will return to the clinic for a physical exam, review of side effects,~     lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1~     year as long as their tumors are shrinking. Follow up visits take up to 2 days.~   "
107992|NCT02153892|"~     To assess the safety and performance of the GDS Accucinch System when used percutaneously to~     reduce functional mitral regurgitation.~   "
107993|NCT02153879|"~     The structural and functional alterations of high density lipoproteins (HDL) levels in type 2~     diabetes (T2D) patients linked to hypertriglyceridemia, hyperglycemia, insulin resistance,~     inflammation and oxidation, play a major role in the increased macrovascular risk in these~     patients. An impaired function of the adipose tissue (AT) in T2D contributes to low HDL~     concentrations.~      Objectives: 1) Quantitative and qualitative characterisation of HDL subclasses by~     ultracentrifugation, proteomic and metabolomic techniques. 2) To study the relationship~     between the HDL subclasses, preβ1 HDL and remnant HDL, and clinical determinants of~     arteriosclerosis. 3) Functional in vitro studies of the HDL subclasses determined in~     Objective 1. 4) To study the role of AT determining the low HDL levels. 5) To study the~     impact of HDL increasing drugs on HDL qualitative changes.~   "
107994|NCT02153866|"~     Nowadays these are some vaccines being vaccinated simultaneously, and a doubt is aroused if~     the safety and immunogenicity are same between inoculating several vaccines simultaneously~     and inoculating individually. So we carry out this study.~      The purpose of this study is to evaluate the difference of safety and immunogenicity on~     vaccinating rotavirus vaccine simultaneously with measles-rubella vaccine(MR) or~     measles-mumps-rubella vaccine(MMR) compared to vaccinating rotavirus vaccine, MR or MMR~     individually.~   "
107995|NCT02153853|"~     Obesity is on the rise in the Western population and BMI has been shown to be associated with~     an increased risk of per- and postoperative complications.~      The investigators intend to study a population of more than 300 patients undergoing~     laparoscopic surgery for rectal cancer.~      The investigators main outcome measure will be the conversion rate, and the investigators~     also intend to study other indications of short term complications, such as peroperative~     bleeding, infection, re-operation and mortality.~      The investigators hypothesise that increased BMI does not increase the risk of conversion.~   "
107996|NCT02153840|"~     The purpose of this study is to evaluate the efficacy and safety of Chinese herbal~     PSORI-CM01（YXBCM01） granule for stable plaque psoriasis, with blood stasis syndrome of~     Chinese Medicine.~   "
108000|NCT02153788|"~     The purpose of this study is to test two study drugs, one of which is temazepam (15mg) and~     one of which is a placebo (an inactive substance that looks just like the temazepam), to see~     if insomnia (trouble sleeping) can be reduced in patients with HIV infection. Placebos are~     given in research studies to try and make sure that subjects are responding to the effects of~     the study drug and not to other factors, like the attention they are receiving. If you decide~     to take part in this study, you will take 1 capsule of study drug every night approximately~     30 minutes before bedtime for approximately 12 weeks.~      This study is to test the study drug called temazepam for the treatment of insomnia (trouble~     sleeping) in patients with HIV infection. Temazepam has been approved by the FDA for the~     treatment of insomnia. However, because this study requires treatment for 12 weeks instead of~     the 7 to 10 days approved by the FDA, the use of temazepam is considered to be~     investigational in this study.~   "
108001|NCT02153775|"~     Cigarette craving usually occurs with unpleasant feelings, including stress. Progressive~     Muscle Relaxation (PMR) may reduce level of cigarette craving and/or withdrawal symptoms.~   "
108002|NCT02153762|"~     The purpose of this study is to evaluate the safety and tolerability, as well as~     effectiveness, with regards to the order of application for Locoid Lipocream and Hylatopic~     Plus cream in patients with atopic dermatitis (AD), which is a type of skin rash.Topical skin~     barrier repair therapies (BRT) that are plain moisturizing creams/lotions with added lipids~     (fats/oils), such as Hylatopic Plus cream, have emerged as an effective addition to the the~     treatment of atopic dermatitis. BRTs are often used along with topical steroids (medicated~     creams), such as Locoid lotion, on skin with AD, and as a monotherapy (single treatment) on~     both non-diseased and diseased skin. Since BRTs help to restore components of skin that are~     absent in skin with AD, it is believed that long-term BRT use may reduce further development~     of further AD. This is an open-label, single site study.~   "
108003|NCT02153749|"~     The investigators propose that brief training in regulation of craving may increase the~     efficacy of smoking cessation, but that training in cognitive vs. mindfulness-based~     strategies may operate via different psychological and neural mechanisms.~   "
108004|NCT02153736|"~     The primary aims of this randomized controlled trial are to evaluate efficacy potential of~     SPEEDI at enhancing reaching and play based problem solving compared to infants receiving~     usual care.~   "
108005|NCT02153723|"~     A phase 2 open label trial to test a potential drug treatment for Rett syndrome, the leading~     known genetic cause of severe neurological impairment in girls. The drug, Copaxone (generic~     name - Glatiramer acetate) is medication FDA approved for the treatment of multiple~     sclerosis. Copaxone's high safety profile has been documented in large cohorts of patients~     for more than 12 years.~   "
108006|NCT02153710|"~     This is a behavioral speech therapy trial for individuals who have suffered a stroke on the~     left side of the brain and have difficulty speaking. The name of this disorder is called~     aphasia. Individuals in this study will receive one of two treatments. The first is a~     phonological (sound level) treatment and the second is a semantic (word level) treatment.~     Individuals in both groups will receive 60 hours of therapy for free (2 hours/day, 5~     days/week, 6 weeks).~   "
108007|NCT02153697|"~     Benign pigmented lesions as solar lentigines are a common finding in Caucasian individuals.~     Their removal may be requested for aesthetic reasons.~      The goal of the study is comparing the efficacy and tolerance of two different therapy~     modalities established for treating solar lentigines.~      The right back of the hand side will be treated with the Q-switched SINON Rubin 694nm Laser,~     the left back of the hand side with a hydrochinon containing bleaching cream (Pigmanorm®~     cream).~      The investigators estimate that a physical therapy with a Q-switched Rubin laser system is~     more effective in the removal of solar lentigines than a topical chemical therapy with a~     hydrochinon containing bleaching cream.~   "
108008|NCT02153684|"~     The Canadian Respiratory Research Network (CRRN) has recently been established to study the~     origins and evolution of airways disease in the population. The CRRN is funded by the~     Institute of Cardio-respiratory Health (ICRH), an institute of the CIHR. The Physiology~     platform will support the other CRRN platforms (biology, imaging, population health,~     knowledge transfer) by providing a comprehensive characterization of the nature and extent of~     physiological impairment of respiratory function in smokers at risk for airways disease and~     in those with early or mild airway obstruction. The planned studies of the physiology group~     (core sites located at Queen's University, University of British Columbia and McGill~     University) will initially focus on smoking-related lung injury in those at risk for COPD and~     in those meeting spirometric criteria for mild airway obstruction, with or without~     respiratory symptoms. The primary aim of this initial study is to identify and validate~     sensitive test(s) of peripheral airway dysfunction that may qualify as physiological~     biomarkers for use in future CRRN studies.~   "
108009|NCT02153671|"~     This study is designed to assess whether a live attenuated Influenza vaccine (LAIV) can~     induce a long-lasting immune memory by comparing the immunologic response to two doses of the~     OrniFlu® inactivated vaccine given to subjects previously primed with LAIV and subjects who~     did not received LAIV.~   "
108010|NCT02153658|"~     The PrePex is a WHO prequalified medical device for adult male circumcision for HIV~     prevention. The Government of Rwanda was the first country to implement the PrePex and acts~     as the leading Center of Excellence providing trainings and formal guidelines. As part of the~     Government's efforts to improve the PrePex implementation, it made efforts to improve the~     psychology acceptability of the PrePex by men and thus to increase the uptake with VMMC in~     sub-Saharan Africa.~      Some men who gone through the PrePex procedure complained of foreskin odor while wearing the~     PrePex 3-7 days after it is placed. This complaint was identified as potential risk for the~     PrePex uptake. Researchers from Rwanda assumed there is a possible relation between the level~     of foreskin odor to the patient foreskin hygiene technique. It was speculated that a patient~     that follows an appropriate foreskin hygiene technique while wearing the device will have a~     significantly lower foreskin odor on day 7 than a patient who does not follow such technique.~     The Government of Rwanda decided to investigate those assumptions in a scientific way and~     conduct a study to test different hygiene cleaning methods in order to increase the~     acceptability of PrePex and mitigate the odor concern.~   "
109148|NCT02138773|"~     The purpose of this study is to investigate the relative bioavailability of two types of~     prolonged release formulation of tamsulosin hydrochloride in Chinese healthy subjects. The~     safety of tamsulosin formulation is also compared.~   "
108011|NCT02153645|"~     Amantadine has been used for many years as a treatment for Parkinson's disease. It has been~     reported in the literature to effectively treat the motor complications of levodopa,~     especially dyskinesia, but it must be given 2 to 4 times a day. The purpose of this~     multi-center, randomized, double-blind, parallel-group, 16 week study is to compare the~     efficacy and safety of two different dose levels of Amantadine Extended Release Tablets to~     placebo for the treatment of levodopa induced dyskinesia in patients with Parkinson's~     disease. The dose will be given once a day in the morning so that amantadine concentrations~     are maintained throughout the day for treating the levodopa induced dyskinesia, but will be~     lower during the night, potentially reducing the negative impact of amantadine on sleep.~   "
108012|NCT02153632|"~     Amantadine HCl ER has been used for many years as a treatment for Parkinson's disease. It has~     been reported in the literature to effectively treat the motor complications of levodopa,~     especially dyskinesia, but it must be given 2 to 4 times a day. The purpose of this~     multi-center, randomized, double-blind, parallel-group, 26 week study is to compare the~     efficacy and safety of two different dose levels of Amantadine Extended Release Tablets to~     placebo for the treatment of levodopa induced dyskinesia in patients with Parkinson's~     disease. The dose will be given once a day in the morning so that amantadine concentrations~     are maintained throughout the day for treating the levodopa induced dyskinesia, but will be~     lower during the night, potentially reducing the negative impact of amantadine on sleep.~   "
108013|NCT02153619|"~     Many parents who have lost a child use counseling or other resources to help with the~     emotional burden of their loss. The aim of this study is to begin to test a new counseling~     program for parents who have lost a child to cancer.~   "
108014|NCT02153606|"~     All premature babies have problems with feeding and nutrition. Some can develop a~     life-threatening bowel infection necrotizing enterocolitis. This can result in the need for~     emergency surgery, loss of bowel, lifelong feeding problems, and death. Giving premature~     babies glycerin suppositories may be one way to stimulate the digestive tract and help~     prevent these problems. To see if this treatment works, the investigators need to study~     hundreds of premature babies in a large trial involving multiple hospitals. The purpose of~     this project is to carry out a small study first and make sure that the larger trial is~     feasible. The investigators will invite approximately 30 premature babies from the Neonatal~     Intensive Care Unit at McMaster University Medical Centre to participate in this study over a~     6-month period. The investigators will focus on feasibility issues, including cost, safety,~     and rate of participation. This will allow us to rigorously test our study protocol and lay~     the groundwork for the larger study involving multiple hospitals.~   "
108015|NCT02153593|"~     Massive bone tumour resection is often associated with important postoperative bleeding. This~     may determine systemic (anaemia), as well as local complications (wound healing, seroma,~     haematoma).~      The objective of this study is to determine whether the use of topical tranexamic acid or~     topical Evicel® will reduce the perioperative bleeding comparing it with usual haemostasis.~   "
108016|NCT02153580|"~     This phase I trial studies the side effects and best dose of cellular immunotherapy following~     chemotherapy in treating patients with non-Hodgkin lymphomas, chronic lymphocytic leukemia or~     B-cell prolymphocytic leukemia that has come back. Placing a modified gene into white blood~     cells may help the body build an immune response to kill cancer cells.~   "
108017|NCT02153567|"~     Background:~      Functional dyspepsia is one of the commonest digestive disorders. The pathophysiology of~     functional dyspepsia (FD) is uncertain. Clinical experience and community studies show that~     FD is strongly associated with common mood disorders especially depression and anxiety~     disorders, which can be treated with serotonin selective uptake receptor (SSRI).~      Our previous study shows that the relief of FD symptom has an association with the change of~     plasma serotonin and ghrelin profile. However, the correlation between plasma serotonin level~     in FD patients treated with SSRI is lacking in these studies.~      Indication:~      Functional dyspepsia patients~      Study center(s):~      Prince of Wales Hospital, Hong Kong~      Aims :~        -  To evaluate the effect of SSRI treatment on change of plasma serotonin level~        -  To evaluate the relationship between dyspeptic symptom and change of plasma serotonin~          level~      Study medication:~      Escitalopram (Lexapro) 5mg daily for first 2 weeks, and then 10 mg daily for 8 weeks versus~     Placebo for 10 weeks~      Study design:~      Double-blind randomized placebo-controlled trial~      Number of subjects:72~      - 36 patients (18 male and 18 female) and 36 age-and-sex-matched healthy controls~      Patient population:~      Functional dyspepsia patients age 18-60, with element of anxiety or depression~      Duration of study: 1 June 2013 - 30 November 2015~      Primary variable(s):~      Change of serotonin and ghrelin level in blood plasma after medication treatment~      Secondary variable(s):~      Rate of adequate relief using global symptom assessment and symptom scores~      Number of visits: 2~   "
108018|NCT02153554|"~     The purpose of this study is to determine whether the training of civil servants leads to a~     reduction in the violence suffered by women, as well as in their psychological wellbeing and~     attitudes towards violence.~   "
108019|NCT02153541|"~     This is a double-blind, randomized, placebo-controlled, proof of concept, study in adults~     with poorly controlled moderate to severe asthma. The researchers believe that by using a~     local anesthetic to block a certain nerve in the ear, it will improve all aspects of asthma,~     such as decreasing the numbers of times patients have to use a rescue inhaler, and improving~     asthma treatment assessment questionnaire scores, with no bad changes to lung function and~     inflammation.~   "
108033|NCT02153359|"~     This study is about asthma and how the environment affects asthma. Scientists know that air~     pollution (such as cigarette smoke and other particles in the air) can make asthma symptoms~     worse. This research is being done to study how the health of a person with asthma responds~     to an air cleaner. The investigator hypothesize that an air cleaner will improve the health~     of persons with asthma.~   "
108034|NCT02153346|"~     Rationale Asthma is a chronic inflammatory disorder of the airways affecting persons of all~     ages and is recognized as one of the most common chronic diseases. Canada has one of the~     highest asthma prevalence rates in the world (8.5%, aged 12 and over) and it is a major cause~     of hospitalization. The cost of asthma varies dramatically across disease severity, and it is~     expected that these costs are greater when the condition is sub-optimally managed and~     controlled. Although a number of publications have been reported on the economic burden of~     asthma, there is a lack of information on the cost of asthma based on disease severity and~     level of disease control in Canada. The proposed study aims to i) estimate the annual~     indirect cost of asthma and ii) the impact of asthma on absenteeism, presenteeism and work~     productivity in Canada. This information is essential to further quantify the burden of~     asthma on patients and the healthcare system in the Canadian setting.~      Overall Objectives The overall objective of this study is to describe the impact of asthma on~     patients with moderate to severe asthma and to estimate the indirect costs of asthma care in~     asthmatic patients followed in tertiary clinics specialized in the field of asthma in Quebec,~     Canada.~      Study Design~      A prospective cohort study will be conducted to measure the indirect economical burden of~     asthma on patients. Patients will be selected and recruited from the BD-Asthma registry and~     followed prospectively for 1 year. Recruited patients will be asked to complete~     questionnaires at regular intervals for 1 year to measure indirect cost of disease, using the~     Valuation of lost productivity (VOLP) questionnaire.~      Data Collected For each patient, the following data will be collected~        -  Patient demographics~        -  Age~        -  Sex~        -  Income~        -  Level of education~        -  Smoking~        -  Disease management and Treatment utilization in the year prior to recruitment~        -  Physician visits and follow up~        -  Hospitalizations (number and total days)~        -  Emergency room visits~        -  Disease characteristics~        -  Asthma history~        -  Year of first diagnosis of asthma severity~        -  Asthma Control Questionnaire score~        -  Lung function measures~      Data Analysis Methods For each participant, the percentage of time missed from work over a~     year will be calculated. We will use the human capital approach to calculate the costs of~     asthma due to lost productivity, incorporating both absenteeism and presenteeism in the~     calculation of the productivity loss. We will calculate the number of work days in which the~     person was unable to attend the workplace, and the number of days and percentage of time lost~     during the days the person's work was affected by their asthma. The fraction of time lost~     from work in the past year will be multiplied by the average income in Quebec. Finally, this~     value will be multiplied by the coefficient generated by the VOLP, which reflects the~     relative value of the productivity loss. In addition, we will calculate the VOLP multiplier~     for each participant which, combined with the percentage of time missed from work, will~     create a measure of productivity loss adjusted for the relative importance and~     replace-ability of the participant's profession.~      Sample Size and Power~      One hundred subjects will be randomly selected from the BD-Asthma registry.~      Limitations~      The study population may not be representative of the general asthma population, as moderate~     to severe asthma will be over represented in these tertiary centers.~   "
108035|NCT02153333|"~     This study aims to evaluate the serologic response to PCV-1 in the serum samples previously~     collected during initiation of vaccination series of Human Rotavirus (HRV) vaccine studies~     (1-2 months post Dose 2 of HRV vaccine or placebo). Additionally, pre-vaccination sera~     samples from any infants testing positive for PCV-1 antibodies at the post-vaccination time~     point will also be evaluated.~   "
134295|NCT01809483|"~     This research aims to compare between bandage contact lens and pressure patching in reducing~     size of erosion area and pain scale in corneal erosion patients as well as its complications.~   "
108020|NCT02153528|"~     - Hypothesis: Double dose rifampicin together with earlier monitoring of sputum conversion~     using vital staining reduces unfavorable outcome of Cat. 1 first-line TB treatment without~     excess serious toxicity, and allows early switch to specific treatment of MDR-TB without~     using Cat. 2 retreatment regimen~      - General study design: This open label, randomised clinical trial is intended as a pilot~     study on the efficacy and safety of high-dose rifampicin and feasibility and added value of~     auramine and/or FDA vital staining sputum smear after 2 weeks of intensive treatment phase.~     If this proof-of-concept study provides substantial indication of benefit without indication~     of excess toxicity, the data from the study will be used to design a larger scale,~     cluster-randomized study. The aim of this cluster randomised study would be to provide~     definite proof of the benefit of the intervention on adverse treatment outcomes and lack of~     excess toxicity associated with high dose rifampicin. In addition, the cluster-randomized~     study would provide a more precise assessment of the suppression and prevention of (acquired)~     resistance endpoints.~      An interim analysis is thus planned at the time the last recruited patient finishes~     treatment, i.e. about 9 months after the end of recruitment. It will focus on assessment of~     drug toxicity versus suggested benefits of the intervention. This analysis will be primarily~     performed for the go/no-go decision and design considerations for the cluster-randomized~     trial. The decision on proceeding to the cluster randomized study will be based on the~     absence of excess toxicity, a trend toward a reduction of unfavourable outcomes (excluding~     relapse), and possible favourable effects on initially present low-resistance mutations /~     mutations acquired during treatment. It will also allow to adapt the design of the larger~     study particularly regarding the algorithm for resistance screening, and whether or not~     treatment shortening could be justified with rapid initial conversion.~   "
108021|NCT02153515|"~     To investigate if fresh finger prick autologous blood (FAB) instead of serum from~     venesection, is a safe and effective treatment for dry eyes and corneal ulcers/ epithelial~     defects. Currently there are no studies on the use of whole fresh blood for the treatment of~     chronic ulcers, persistent epithelial defects or dry eyes. Unpublished case reports indicate~     that fresh blood can be an effective tool to the treatment of corneal pathology.~   "
108022|NCT02153502|"~     The objectives of this 10-week study are to evaluate the efficacy, safety, and tolerability~     of AVP 786 as an adjunctive therapy compared with placebo in patients with major depressive~     disorder (MDD) who have shown an inadequate response to standard antidepressant treatment. A~     secondary objective of this study is to assess the pharmacokinetics (PK) of AVP-786 and~     potential correlations with pharmacodynamic effects.~   "
108023|NCT02153489|"~     The purpose of this study is to assess the effect of aclidinium bromide compared with placebo~     in improving dilatation of the airways (bronchodilation), symptoms of chronic obstructive~     pulmonary disease (COPD), sleep quality and physical activity after 3 weeks of treatment with~     aclidinium bromide 400 μg administered twice daily in patients with stable~     moderate-and-severe COPD.~   "
108024|NCT02153476|"~     Evaluate the safety and efficacy of ophthalmic intravitreal injection of ALG-1001 in human~     subjects with symptomatic focal vitreomacular adhesion~   "
108025|NCT02153463|"~     Tics are brief repetitive movements or vocalizations. Gilles de la Tourette's syndrome (TS)~     is a disorder characterized by recurrent motor and vocal tics. Tourette syndrome and tic~     disorders affect up to 8% of children. Peak severity of tic disorders occurs between the ages~     of 8 to 12 years, therefore during childhood and adolescence the most significant impacts are~     felt. The quality of life of young people with tics is lower than their peers' and tic~     severity predicts lower quality of life. Studies have also shown negative social perception~     toward children with tics.~      Approximately 50% of patients with Tourette syndrome will have other diagnoses including~     attention deficit hyperactivity disorder (ADHD), obsessive compulsive disorder, anxiety and~     depression. Studies have shown improvements in ADHD with physical activity. ADHD and tic~     disorders are thought to involve the same areas of the brain; thus it is possible that tics~     might also improve with physical activity. However, no studies to date have examined this.~     The investigators predict that by implementing a motivational physical activity program, in~     conjunction with physical activity counseling, the investigators will be able to increase~     levels of physical activity in children with tics and Tourette syndrome, with a positive~     impact on tic severity.~   "
108026|NCT02153450|"~     This pilot clinical trial studies stereotactic radiosurgery and metformin hydrochloride in~     treating patients with pancreatic cancer that may be removed (borderline-resectable) or not~     removed by surgery. Stereotactic radiosurgery may be able to send x-rays directly to the~     tumor and cause less damage to normal tissue. Metformin hydrochloride, used for diabetes, may~     also kill cancer cells as demonstrated in laboratory studies. Giving stereotactic~     radiosurgery with metformin hydrochloride may kill more tumor cells.~   "
108027|NCT02153437|"~     To determine the effect of our compound (BMS-919373) on electrical activity of the heart~     using pacemakers.~   "
108028|NCT02153424|"~     The primary objective of the study is to identify and describe any suspected (AEs) in all~     patients with NVAF treated with Apixaban, as a request of the National Center of~     Pharmacovigilance (CNFV) in Mexico.~   "
108029|NCT02153411|"~     Descriptive study on the management of asthma in asthmatic Middle East adult population :~     Algeria,Egypt, Irak,Iran, Jordan, Koweit, Lebanon, Qatar,Saudi,Tunisia, UAE~   "
108030|NCT02153398|"~     The objective of this study is to assess the safety, pharmacokinetics, pharmacodynamics and~     efficacy of repeated once daily oral administration of D961H 10 mg and D961H 20 mg in~     Japanese paediatric patients aged 1 to 14 years old who either have a diagnosis of or are~     suspected to have gastric ulcer (GU), duodenal ulcer (DU), anastomotic ulcer (AU),~     non-erosive reflux esophagitis disease (NERD), reflux esophagitis (RE) or Zollinger-Ellison~     syndrome.~   "
108031|NCT02153385|"~     Background: Women are more likely to suffer from depression and anxiety, which have been~     linked to reduced heart rate variability (HRV) and increased cardiovascular morbidity and~     mortality. The purpose of this study was to examine the effects of an 8-week yoga program on~     HRV and mood in generally healthy women. The investigators hypothesized that there would be~     improvements in HRV and reductions in perceived stress and symptoms of depression and anxiety~     after the yoga intervention.~      Methods: Fifty-two healthy women were randomized to either a yoga group or a control group.~     Participants in the yoga group completed an 8-week yoga program, which comprised a 60-minute~     session, twice a week. Each session consisted of breathing exercises, yoga pose practice, and~     supine meditation/relaxation. Participants' HRV, perceived stress, depressive symptoms, and~     state and trait anxiety were assessed at baseline and week 9.~   "
108032|NCT02153372|"~     In the present phase-I clinical trial we investigate safety and feasibility of an~     augmentation with preoperatively isolated autologous BMC cells seeded onto ß-TCP in~     combination with an angle stable fixation (Philos plate®) for the therapy of proximal humeral~     fractures.~   "
124455|NCT01938469|"~     Analyze the effect of meal pattern (meal number, frequency, and form) on satiety, gut~     peptides, insulin, and glucose levels in individuals before and 12-15 months after gastric~     bypass surgery (GBP).~   "
108037|NCT02153307|"~     The purpose of this study is to determine the incidence and predictors of high degree or~     complete atrioventricular block (AVB) (paroxysmal or persistent) in patients with new-onset~     persistent left bundle branch block (NOP-LBBB) following transcatheter aortic valve~     implantation (TAVI) and to evaluate the usefulness of the Reveal LINQ® insertable Cardiac~     Monitor (ICM) (Medtronic, Inc., Minneapolis, USA) for the detection of significant~     arrhythmias in patients with NOP-LBBB following TAVI.~   "
108038|NCT02153294|"~     The purpose of this national multicentre randomized controlled trial is to compare a~     ventilation strategy using lower tidal volumes and higher respiratory rates with a~     ventilation strategy using higher tidal volumes and a lower respiratory rate in intubated and~     ventilated intensive care unit (ICU) patients without Acute Respiratory Distress Syndrome~     (ARDS) at start of ventilation.~      Participating centres in The Netherlands will include a total of 952 adult patients admitted~     to intensive care units without ARDS. Patients are randomized and ventilated with either a~     strategy with lower tidal volumes (4 to 6 ml/kg predicted body weight (PBW)) or a strategy~     with higher tidal volumes (8 to 10 ml/kg PBW). Patients will be assessed every day until day~     28 or discharge of the intensive care unit, whichever comes first, on day 28 and on day 90.~     Primary endpoint is the number of ventilator-free days at day 28. Secondary endpoints are~     ICU- and hospital length of stay (LOS) and - mortality, the incidence of development of ARDS,~     pneumonia, atelectasis, and pneumothorax, the cumulative use and duration of sedatives, and~     neuromuscular blocking agents, incidences of ICU delirium and ICU acquired weakness,~     patient-ventilator asynchrony and the need for decreasing of instrumental dead space.~   "
108039|NCT02153281|"~     The purpose of this study is to determine if monoamine oxidase B (MAO-B) total distribution~     volume (VT), after phenelzine treatment and if so to what extent.~   "
108040|NCT02153268|"~     Phase I/II open label first in human single center clinical study, is to evaluate the safety~     and the efficacy of BonoFill as bone filler containing the patient own (autologous) adipose~     tissue derived cells (HATDCs) in reconstructing the Bone Void in the maxillofacial area~     approximately 6 month follow up after implantation in the following two clinical indications:~        1. Bone augmentation (e.g. sinus augmentation)~        2. Bone grafting after removal of cysts from jaws~   "
108041|NCT02153255|"~     Mucopolysaccharidosis Type IVa (MPS IVa, Morquio Disease) is a rare inherited lysosomal~     storage disorder caused by deficiency of the enzyme galactose-6-sulfatase.~      Children with this disease accumulate a chemical called keratan sulphate, which stops their~     skeletons developing properly. They are very short in stature and many of their joints are~     unstable. Children with MPS IVa walk in a different way to other people due to a combination~     of lax ligaments and skeletal problems such as knock-knees.~      Human walking involves the coordinated movements of all four limbs. As we walk, the arms~     swing oppositely to the legs. This movement pattern is very different in children with MPS~     IVa. This change seems to involve the whole musculoskeletal system and depends on the~     severity of the disease.~      Recent studies in children with MPS IVa describing walking pattern have concentrated solely~     on the lower or upper limb respectively, and have not looked at the interaction of the upper~     and lower limbs during walking.~      To our knowledge, the mechanics of walking in children with MPS IVa has not been investigated~     using a dynamic gait analysis tool (using cameras, sensors and electrodes to track the~     movements of different parts of the body during walking) and we aim to characterise this in a~     small number of children with MPS IVa and also examine the effects of splinting the wrist~     upon the walking pattern to see if this simple intervention makes it easier or more difficult~     for children with MPS IVa to walk.~   "
108042|NCT02153242|"~     This is a pilot study into the effects on heart function when pacing the right ventricle~     (RV). This study aims to enrol a population with structurally normal hearts. The~     investigators aim to measure heart function directly when pacing.~      When normal conduction within the heart fails, the treatment may be to implant a permanent~     pacemaker. Pacing involves passing a lead via a vein to the heart and using an electrical~     impulse to stimulate a beat. The usual site for pacing is the tip of the RV. This has been~     shown to be less efficient than the normal conduction system of the heart and in some cases~     leads to markedly reduced function. What the investigators do not know is why this is the~     case.~      Much effort has been directed at looking at features within the left ventricle (LV) for~     markers of disease progression but little has been investigated regarding the RV.~      There may be some benefit to pacing the heart preferentially from different parts of the RV~     and the investigators aim to measure if any differences are detectable from stimulating the~     heart at various sites within the RV.~   "
108043|NCT02153229|"~     A randomized Phase II trial to test whether the addition of intraoperative Photofrin-mediated~     photodynamic therapy to radical pleurectomy and post-operative chemo.improves OS in the~     treatment of patients with epithelioid MPM. Subjects assigned to the PDT arm will be given~     the photosensitizer prior to surgery . All subjects will receive maximal surgical debulking.~     Subjects in the PDT arm will receive intraoperative treatment using real-time, isotropic~     light dosimetry.~   "
108044|NCT02153216|"~     This study is the Formative Phase of a larger study; once this phase is completed, enrollment~     into the randomized controlled trial (RCT Phase) will begin. The primary objective of the~     Formative Phase is to gain a better understanding of the context in which drinking alcohol~     among ART client in Vietnam occurs, in order to culturally tailor the intervention to be~     tested in the RCT Phase. Formative Phase activities will consist of up to 40 in-depth~     interviews with hazardous drinkers who are either: a) ART clients in one of the ART clinics~     in Thai Nguyen, or b) who are people who inject drugs (PWID) that are not recruited from the~     ART clinics (whom we will refer to as general population PWID).~   "
108061|NCT02152995|"~     This phase II trial studies how well trametinib works in increasing tumoral iodine~     incorporation in patients with thyroid cancer that has come back or spread to another place~     in the body. Trametinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth and may help make treatment with iodine I-131 more effective.~   "
108072|NCT02152852|"~     The purpose of this study is to test the hypotheses that CHWs providing in-home support for~     self-management of type 2 diabetes, resources for diabetes, and assistance in effective~     linkage and communication with medical providers will: (1) improve HbA1c (primary outcome)~     and secondary outcomes including lipids, blood pressure, health care utilization, and~     health-related quality of life; (2) improve diabetes self-management, including~     self-efficacy, physical activity, nutrition, and medication adherence; and (3) be~     cost-effective and feasible.~   "
108045|NCT02153203|"~     Children with autism spectrum disorders often engage in problem behaviors such as~     self-injury, destruction, aggression, and stereotypy. Prior research has clearly shown that~     these problem behaviors may interfere with learning, daily functioning, and social~     participation. As such, engaging in problem behaviors has a negative impact on the health and~     quality of life of children with autism spectrum disorders and their families. One promising~     solution to reduce problem behaviors in this population is the Prevent-Teach-Reinforce (PTR)~     model, which relies on the evidence-based practices of positive behavior support. Although~     the use of PTR has been gaining considerably support in schools, the model has never been~     evaluated as part of a rigorous large-scale study using parents as interventionists. Thus,~     the purpose of the project is to conduct an assessment of the effectiveness of a home-based~     version of the PTR model in reducing problem behaviors in children with autism spectrum~     disorders and in improving families' quality of life. Our hypotheses are that implementing~     the PTR will (a) produce larger reductions in problem behaviors than participating in an~     individual parent training session, (b) increase engagement in prosocial behaviors, (c)~     decrease parental stress, and (c) improve the quality of life of the family. The results of~     the study will allow an examination of whether PTR is an effective and acceptable model to~     reduce problem behaviors at home in this population. Given that problem behaviors incur high~     societal costs when they persist into adolescence and adulthood, the study may potentially~     lead to large cost reductions in the treatment of difficulties associated with autism~     spectrum disorders. By reducing engagement in problem behaviors, the implementation of the~     model may also promote and facilitate the social participation as well as improve the quality~     of life and health of children with autism spectrum disorders and their families.~   "
108046|NCT02153190|"~     The primary purpose of this study is the evaluate an Artificial Pancreas during 2 months in~     home setting in Type 1 Diabetic patients~   "
108047|NCT02153177|"~     The main purpose of the study is to determine the effect of Non-steroidal Anti-inflammatory~     Drugs (NSAIDs) on the healing process after a rotator cuff repair procedure.~   "
108048|NCT02153164|"~     This is a single site, prospective, non-blinded, non-randomized, non-interventional study~     designed to evaluate the effect of changes in patient position on the measurement of~     respiratory heat loss (enthalpy). This study would be carried out on patients whose operation~     requires the use of the steep Trendelenburg position independent of this study.~   "
108049|NCT02153151|"~     This pilot research trial studies the response in blood cells to AMP-514, a drug shown to~     increase immune response (capacity to fight against infections and cancer) against cancer in~     patients with solid tumors undergoing radiotherapy. Measuring changes in biomarkers may help~     doctors decide if AMP-514 should be combined with radiotherapy and when is the best time to~     combine the drug with radiation.~   "
108050|NCT02153138|"~     The investigators' hypothesis is that a plant-based diet may be beneficial if nutritional~     deficiencies will be corrected. The aims of the present proposal are to 1) study endothelial~     functions of subjects on well-defined vegetarian/vegan diets compared to age and sex matched~     omnivores (controls), and 2) study the differences in energy expenditure, body composition,~     overnight substrate utilization, blood work results, and levels of intracellular reactive~     oxygen species (ROS) and of adhesion molecules on the different diets.~   "
108051|NCT02153125|"~     The aim of the study is to determine the efficacy and safety in treating patients with~     chronic central serous chorioretinopathy with the drug eplerenone.~   "
108052|NCT02153112|"~     The purpose of this study is to select the optimal formulation of the norovirus vaccine from~     different concentrations of virus-like particles (VLP) combined with aluminum hydroxide for~     further development in children.~   "
108053|NCT02153099|"~     The purpose of this study is to characterize the safety and tolerability profile of~     escalating dose levels of ENV8058 (TAK-058) solution when administered as a single oral dose~     in healthy adults.~   "
108054|NCT02153086|"~     The purpose of this survey is to examine the safety and efficacy of long-term use of~     ramelteon tablets (Rozerem 8 mg Tablets) in participants with difficulty falling asleep~     associated with insomnia in daily medical practice.~   "
108055|NCT02153073|"~     The purpose of this study is to evaluate the safety and efficacy of long-term use of granular~     capsule formulation of omega-3 fatty acid ethyl esters (Lotriga Granular Capsules) in~     patients with hyperlipidemia in daily medical practice~   "
108056|NCT02153060|"~     The project was undertaking by Qilu Hospital of Shandong University and other 7 well-known~     hospitals in China. In order to report the efficacy and safety of different dose~     dexamethasone in treating the immune thrombocytopenia (ITP).~   "
108057|NCT02153047|"~     There is controversy about the effectiveness of interventions based on spirometry for smoking~     cessation.~      The investigators want to evaluate the effectiveness of motivational intervention performed~     by a doctor to obtain abstinence compared with normal practice in primary care.~      This study, is the second half of what was began with ESPITAP study~   "
108058|NCT02153034|"~     Buruli ulcer is a neglected tropical disease caused by infection with Mycobacterium ulcerans~     (Mu) in rural parts of West Africa. It causes large skin ulcers mainly in children aged 5 to~     15 years. Access to treatment is limited and many cases present late. There have been major~     advances in understanding the mechanism of disease together with improved diagnosis and~     management. The aim of the proposed studies is to identify markers predictive of a rapid~     response to antibiotic treatment and to investigate the pathogenesis of paradoxical reactions~     and oedematous lesions in Mu disease.~      Infection with Mu results in a nodule under the skin which enlarges and breaks down to form~     an ulcer. This is because Mu produces a toxin that spreads outwards and damages subcutaneous~     tissue. In recent years it has been found that antibiotic treatment for 8 weeks with daily~     tablets and intramuscular injections heals ulcers. This is unpleasant and it would be better~     if the treatment could be shortened. Our previous studies suggest this may be possible.~     Therefore a wide range of tests will be investigated in order to identify markers for people~     in whom the infection is at an early stage with low numbers of Mu bacteria and low levels of~     toxin in the skin. During antibiotic treatment the rate of healing will be measured to find~     out which markers are the most reliable.~      In some patients new areas of inflammation develop despite treatment and this is called a~     paradoxical reaction. The immune response to Mu will be investigated serially during~     antibiotic treatment to investigate the cause of paradoxical reactions.~      About 15% of patients have oedematous disease, the most severe form of Buruli ulcer. We will~     study the amount of Mu toxin produced by the strain of Mu cultured from patients with this~     form of the disease.~      Hypothesis~        -  Buruli ulcer patients that heal rapidly/slowly or develop paradoxical reactions with~          treatment will have associated predictive viability or serum biomarkers.~        -  Buruli ulcer patients with oedematous disease are associated with larger amounts of~          mycolactone and viable organisms~   "
108059|NCT02153021|"~     Obesity is a chronic disease of increasing prevalence, being currently considered a global~     epidemic, including children, adolescents, adults and the elderly of different nationalities~     and ethnicities, socioeconomic levels, education levels. Non-pharmacological therapeutic~     interventions, such as physical exercise and fitness healthy eating strategies seem to be~     increasingly studied and recommended for healthy weight loss. In addition, therapies that can~     complement the effect of exercise and diet for reducing body weight are considerate important~     strategies. Thus, experimental evidence shows that the use of laser therapy combined with~     exercise swimming was effective in controlling the lipid profile, reducing the mass of~     adipose tissue, suggesting increased metabolic activity and changes in lipid metabolism.~      To investigate the effect of the use of therapeutic laser when associated to exercise like~     response to new therapy for weight loss and decrease of dyslipidemias levels.~   "
108062|NCT02152982|"~     This randomized phase II/III trial studies how well temozolomide and veliparib work compared~     to temozolomide alone in treating patients with newly diagnosed glioblastoma multiforme.~     Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth~     of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Veliparib may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. It is not yet known whether temozolomide is more effective~     with or without veliparib in treating glioblastoma multiforme.~   "
108063|NCT02152969|"~     To evaluate Drug-drug interaction~   "
108064|NCT02152956|"~     The primary goal of this Phase 1, dose-escalation study, is to determine the maximum~     tolerated dose level of MGD006 in patients with AML and MDS whose disease is not expected to~     benefit from cytotoxic chemotherapy. Studies will also be done to see how the drug acts in~     the body (pharmacokinetics [PK], pharmacodynamics) and to evaluate potential anti-tumor~     activity of MGD006.~   "
108065|NCT02152943|"~     The goal of this clinical research study is to find the highest tolerable dose of Femara~     (letrozole) that can be given in combination with Afinitor (everolimus) and Herceptin~     (trastuzumab) to patients with advanced cancer. The safety of this drug combination will also~     be studied.~   "
108066|NCT02152930|"~     Intermittent claudication (IC) is caused by peripheral arterial disease and has a high~     morbidity and mortality. Etiologic factors are similar to those of cardiovascular disease.~     Primary treatment consists of cardiovascular risk management and improvement of functional~     capacity with supervised exercise therapy (SET). A potential additional therapy is the~     administration of fish oil supplements containing high amounts of omega-3 Poly Unsaturated~     Fatty Acids (PUFAs). In earlier clinical and experimental trials omega-3 PUFA's improved~     hemorheological parameters such as erythrocyte deformability and aggregation, and a number of~     cardiovascular risk factors. Hemorheological parameters determine the blood flow in the~     microcirculation, which is of main importance in patients with IC since the macrocirculation~     is compromised. Inflammation is considered an important etiologic factor in the pathogenesis~     of atherosclerosis and contributes to peripheral arterial disease Since omega-3 PUFAs also~     have a strong anti-inflammatory effect, they might be effective in patients with IC by~     lowering the inflammatory response. In addition, visceral fat rather than obesity in general~     has been recognised as an etiologic and prognostic factor in atherosclerosis.~      We hypothesise that the administration of omega-3 PUFA's in patients with IC has a~     synergistic effect with SET and improves walking distance after SET, by improving~     hemorheological parameters resulting in a better microcirculation. Second, we hypothesise~     that omega-3 PUFA's result in a less proinflammatory of whole blood in response to ex vivo~     stimulation with endotoxin. Third, we hypothesise that omega-3 PUFA's and SET result in a~     decrease in visceral fat mass.~   "
108067|NCT02152917|"~     The total knee arthroplasty (TKA) is a well established option for the treatment of~     osteoarthritis in this joint. Nevertheless, there are still some concerns related to the~     peri-operative management of elderly patients, highlighting the complications related to~     medical comorbidity and bleeding produced by surgery. One of the proposed methods to decrease~     postoperative bleeding, which has been accumulating favorable evidence, is the use of~     tranexamic acid (TA). Several studies (including prospective randomized trials with placebo~     group) showed excellent results with TA intravenous administration during TKA, reducing the~     amount of bleeding, the drop in hemoglobin and the need for blood transfusion. Another~     alternative to minimize bleeding is the use of topical hemostatic agent Floseal®, composed of~     thrombin and bovine gelatin. This substance has presented significant benefits on bleeding~     control in several areas of medicine, including orthopedic surgery, but no action has yet~     been established in TKA. The main objective is to evaluate the amount of bleeding, the drop~     in hemoglobin and the need for blood transfusion after TKA, comparing the use of TA, Floseal®~     and a control group. The secondary objective is to evaluate the rate of adverse events in the~     studied groups.~   "
108068|NCT02152904|"~     The purpose of the investigators study is to investigate the factors associated with~     rebleeding in patients with peptic ulcer bleeding.~   "
108069|NCT02152891|"~     Older adults living in subsidized housing report poorer health. Their age and low income make~     it harder for them to use community services. Many older adults have heart disease and~     diabetes, which lead to frequent emergency calls and hospital admissions. To decrease the~     costs of treating heart disease and diabetes through emergency and hospitalization, improved~     screening and health education is needed. Our program will take place in communal areas~     within housing buildings of older adults and deliver a heart disease, diabetes, and falls~     risk check-up with health education. This is expected to improve the health of older adults~     leading to fewer emergency calls and hospital visits.~   "
108070|NCT02152878|"~     Non-invasive brain stimulation therapies have been increasingly investigated in recent years~     as a treatment for neuropsychiatric disorders, particularly mood disorders. They are~     particularly appealing since many patients are either refractory or present side effects to~     standard pharmacological regimens. TDCS (transcranial direct current stimulation). a novel~     non- pharmacological brain stimulation technique, might help in overcoming some of these~     issues, since it has low cost, high portability and it is relatively easy to use. TDCS~     consists in applying a weak, direct current through two electrodes placed over the scalp; the~     anode and the cathode increasing and decreasing cortical excitability during and beyond the~     period of stimulation. It is also a safe technique with only mild adverse effects described.~     Previous studies, some of them from our group, have described that tDCS is an effective~     technique for major depression. However, the role of tDCS as a treatment for bipolar~     depression (BD) has been insufficiently investigated. Therefore, our aim is to address the~     antidepressant effects of tDCS in BD in a randomized, sham- controlled trial in a refractory~     sample.~   "
108071|NCT02152865|"~     For the chemical lupeol isolated from eggplant, we applied it to one side of face, and~     applied vehicle control to another side for 8 -weeks. The study was performed in a 8-week,~     randomized controlled, split face fashion. Investigators evaluated safety and efficacy during~     baseline, 2 weeks, 4weeks, and 8 weeks after beginning of study.~   "
108083|NCT02152709|"~     The main objective of this study was to evaluate the safety and immunogenicity of 10µg/0.5ml~     and 5µg/0.5ml hepatitis B vaccine made by recombinant deoxyribonudeic acid techniques in~     saccharomyces cereviside yeast for infants and other age groups.~   "
108073|NCT02152839|"~     Maintenance of body's skeletal muscle is key to a healthy older age. However, as we age we~     lose on average 1-2% of our muscle each year. In order to slow this loss we need to~     understand fully the mechanisms regulating muscle mass with ageing. In this project we aim to~     determine these mechanisms using a new novel technique of 'heavy' water ingestion, which will~     allow us to measure multiple aspects of skeletal muscle mass control during normal everyday~     activities in young and old individuals over a period of 6 weeks. We will also determine the~     influence of resistance exercise training during this period in offsetting declines in muscle~     with ageing using this method~   "
108074|NCT02152826|"~     This study will compare the safety and effectiveness of two water-based potassium oxalate~     desensitizers on existing dentinal hypersensitivity.~   "
108075|NCT02152813|"~     This proposed study aims to compare the effects of unilateral and bilateral transcutaneous~     electrical nerve stimulation (TENS). It will compare the effectiveness of bilateral TENS +~     task-oriented training (TOT) with unilateral TENS+TOTin improving muscle strength,~     co-ordination, dynamic standing balance, walking performance, and functional mobility in~     patients with chronic stroke.~      The null hypothesis will be that bilateral TENS+TOT and unilateral TENS+TOT are not~     significantly different in promoting the recovery of these functions.~   "
108076|NCT02152800|"~     The purpose of this study is to compare the safety and efficacy of Vacyless® and Valtrex® in~     patients with acute herpes zoster.~   "
108077|NCT02152787|"~     The occurrence of emergence agitation (EA) in pediatric patients who have received~     sevoflurane anesthesia is a common postoperative problem. Among various strategies for~     reducing the incidence and severity of EA, the use of pharmacological agents at the end of~     anesthesia is thought to be the most convenient and easily applicable method in clinical~     situation. The one of typical agents that can be administered in this way is propofol.~     Previous studies demonstrated that the use of propofol 1mg/kg at the end of anesthesia could~     reduce the incidence of EA with low incidence of postoperative nausea and vomiting. However,~     it was also demonstrated that the use of propofol 1mg/kg at the end of anesthesia could delay~     the emergence time. The purpose of this study is to compare the preventive effect on EA and~     the emergence time between propofol 1mg/kg and propofol 0.5mg/kg administered at the end of~     sevoflurane anesthesia.~   "
108078|NCT02152774|"~     To evaluate the ocular hypotensive efficacy of Rho kinase Inhibitor (AR-12286 0.5% and 0.7%)~     ophthalmic solutions in patients diagnosed with chronic angle-closure glaucoma treated for 6~     months.~      Secondary Outcome~      Secondary objectives are:~        1. To evaluate the early effect of Rho kinase Inhibitor (AR-12286) in reducing intraocular~          pressure (IOP).~        2. To evaluate the long term effect of the drug on IOP.~        3. To determine if AR-12286 can be used as directed therapy for CACG, reducing or~          eliminating the structural blockage of the trabecular meshwork that leads to development~          of elevated IOP.~   "
108079|NCT02152761|"~     The purpose of this study is to assess if bimagrumab is safe and effective in patients with~     muscle wasting (atrophy) after hip fracture surgery.~   "
108080|NCT02152748|"~     Summary of scientific evidence and rationale of this project:~      Integrative molecular-genetic approaches have provided important insights in the biology of~     glioblastoma. It has meanwhile become clear, that glioblastoma is not a single tumor entity~     but comprises different molecular subtypes, which are associated with a distinct~     genetic/epigenetic signature and prognosis. Multimodal treatment approaches combining radio-~     and chemotherapy as well as the recent introduction of novel antiangiogenic agents have~     resulted in increasing survival times and improved quality-of-life of glioblastoma patients.~     Yet, despite these intense treatment efforts the therapeutic efficacy in glioblastoma~     patients is limited, leading in virtually all cases to tumor recurrence and death of the~     patients.~      As only a limited fraction of glioblastoma patients undergo second neurosurgery at tumor~     recurrence (< 10%), post-therapeutic samples are rare and no systematic, large-scale studies~     exist, which address post-therapeutic morphological and molecular alterations in glioblastoma~     tumor tissue. Yet, these data would help to improve the understanding of mechanisms involved~     in therapy-resistance and tumor progression, to develop new therapeutic approaches and could~     pave the way for personalized treatment strategies.~   "
108081|NCT02152735|"~     PURPOSE:~      To test the hypothesis that omission of intrauterine cleaning during cesarean deliveries does~     not increase intraoperative and postoperative complications.~      METHODS:~      We plan to randomize 206 women undergoing primary and repeat cesarean deliveries to cleaning~     (n=103) versus no cleaning (n=103) of the uterine cavity following placental delivery. Women~     will be excluded if any of the following criteria are encountered: preterm premature rupture~     of membranes, spontaneous rupture of membranes prior to cesarean section, chorioamnionitis,~     fetal demise, uncontrolled diabetes or an immunosuppressive disorder. Primary outcome measure~     will be endo-myometritis after delivery. Secondary outcomes will include post partum~     hemorrhage, mean surgical time, retained products of conception, retained placenta,~     quantitative blood loss, length of hospital stay, return of gastrointestinal function, repeat~     surgery, and hospital readmission rates. Analysis will follow the intention-to-treat~     principle.~      GENERAL DESIGN All eligible patients who are scheduled for cesarean section at the Sparrow~     hospital/Michigan State University Resident OBGYN and Perinatology clinics will be evaluated~     for study inclusion. Patients meeting this study's inclusion criteria and lack exclusion~     criteria will be approached for consent and enrollment.~   "
108082|NCT02152722|"~     The effect of radiation on normal tissue varies widely between individuals. Consequently, a~     test to measure tissue response to radiation could be clinically useful by permitting more~     accurate titration of dosage in patients undergoing radiotherapy. Also, in view of emerging~     concerns about possible nuclear terrorism a test for exposure to radiation might also be~     useful in evaluating victims of a dirty bomb explosion. A number of different techniques~     have been previously reported in epidemiological studies for the estimation of prior~     radiation exposure. This study explores one approach to estimating radiation exposure by~     measurement of increased oxidative stress which can be detected by a breath test.~      In this study subjects undergoing significant exposure to therapeutic radiation will provide~     breath samples for analysis in a central laboratory. The hypothesis of the study is that the~     analysis of these samples will lead to the identification of a set of markers of radiation~     exposure.~   "
134332|NCT01809002|"~     Processed Nerve Allograft and Collagen Nerve Cuffs will be compared to assess safety and~     functional outcomes for the repair of nerve injuries in the hand.~   "
108084|NCT02152696|"~     This is a randomized controlled trial to compare three currently available management~     strategies for women with a persisting pregnancy of unknown location (PPUL), which makes them~     at-risk for ectopic pregnancy. We will recruit hemodynamically stable women with a confirmed~     PPUL to be randomized to one of three strategies: 1) Uterine evacuation followed by~     methotrexate (MTX) for some (those that have evidence of a non visualized ectopic pregnancy)~     2) Empiric treatment with MTX for all 3) Expectant management. Randomization will be 1:1:1~     into these three arms. After randomization, they will be followed and treated clinically as~     is indicated by the progression of their condition. Primary outcome measures: uneventful~     decline of hCG to 5 IU/mL.~   "
108085|NCT02152683|"~     The study is aimed at comparing the performance of protocols employing one and two sessions~     per week, respectively. The study hypothesis claims that there is no significant difference~     between the performances of the compared protocols.~   "
108086|NCT02152670|"~     Studies using positron emission tomography (PET) have been used with great success in~     demonstrating specific abnormalities in several facets of dopaminergic system function in~     human populations (Narendran and Martinez 2009). Among the first, most consistent, and~     broadly replicated of such findings in drug‐ (including cocaine) dependent individuals has~     been the reduction in subcortical (striatal) D2/3 receptors as imaged, most commonly, by the~     reversible, non‐selective, D2/3 receptor antagonist radiotracer, [11C]raclopride. Certain~     dissociations on D2/3 availability by radioligand ([11C]raclopride vs. [11C]PHNO) and by~     brain region (striatum vs. SN; terminal vs. somatodendritic, respectively) are poorly~     understood in relationship to prior antagonist tracer results. In the current study the~     investigators will use pharmacological interventions (AMPT and methylphenidate) with both~     antagonist and agonist radiotracers to experimentally reconcile these discordant findings and~     clarify potential mechanistic inter‐relationships.~   "
108087|NCT02152657|"~     The purpose of this study is to analyze the safety and efficacy of mesenchymal stem cell~     transplantation through percutaneous injection in patients with chronic spinal cord injury.~   "
108088|NCT02152644|"~     This is a cross sectional study to estimate the prevalence of the presence of amyloid~     deposits in a biopsy of subcutaneous fat cell, carpal flexor retinaculum and synovial tissue~     sheath of the flexor tendons requirement for carpal tunnel surgery.~   "
108089|NCT02152631|"~     The main purpose of this study is to evaluate how safe and effective the study drug known as~     abemaciclib is in participants with lung cancer.~   "
108090|NCT02152618|"~     The intervention provides services to children with Serious Emotional Disturbance (SED) who~     are in foster care and to their parent(s) to prepare the families for reunification.~   "
108091|NCT02152605|"~     This study is a 12-week, multicenter, randomized, double blind, parallel group,~     placebo-controlled study.~      The purpose of this study is to replicate the therapeutic benefit of UMEC/VI 62.5/25~     microgram (mcg) on health-related quality of life as reflected by St. George's Respiratory~     Questionnaire (SGRQ) scores and symptoms as reflected by rescue medication use observed in~     the 6 month placebo controlled study (DB2113373). Lung function will be assessed as it~     provides an objective measure to support the subjective patient reported outcomes of SGRQ and~     rescue medication use. The study is intended to provide additional evidence to support the~     use of UMEC/VI for the maintenance treatment of COPD Approximately 496 subjects will be~     randomized from approximately 62 centers in order to ensure 422 subjects complete 12 weeks of~     treatment. Eligible subjects will be randomized to UMEC/VI 62.5/25mcg or placebo in a 1:1~     ratio. All treatments will be administered once-daily in the morning via a Dry Powder Inhaler~     (DPI).~      There will be a total of 5 clinic visits. The total duration of study participation will be~     approximately 15 weeks. All subjects will be provided with albuterol/salbutamol to use as~     needed for the relief of COPD symptoms throughout the run-in and double-blind treatment~     periods.~   "
108092|NCT02152592|"~     the primary objective of this study is to assess and compare the efficacy, safety and~     benefits of Controlled Release (CR) oxycodone/paracetamol with our current pain protocol~     (paracetamol/naproxen) in the treatment of acute postoperative pain at home after painful~     day-case surgery. We hypothesize that ambulatory patients postoperatively treated with~     oxycodone/paracetamol will achieve better pain relief with equal side effects compared to~     patients treated with paracetamol/naproxen.~      Our second goal is to assess analgesic adherence in the outpatient setting.~      Endpoints:~      Primary endpoints: pain intensity (Visual analogue scale) Secondary endpoints: -~     side-effects/ adverse effects of study medication~        -  patient satisfaction with pain treatment~        -  compliance to study medication~      Study design:~      Patients scheduled for painful ambulatory surgery (knee arthroscopy, unilateral open or~     laparoscopic inguinal hernia repair) will be enrolled in an open randomized controlled trial~     (RCT) at our pre-assessment clinic.~      Subjects will be enrolled by a study nurse and will be randomized into one of three study~     treatment groups using a computer-generated list. Patients in group 1 (PCM/NAPR) are assigned~     to postoperative analgesia using naproxen 500 mg orally twice a day for 48 hours~     postoperatively. Patients assigned to group 2 (PCM/Oxy1) receive CR oxycodone 10 mg orally~     twice a day for 24 hours. Patients in group 3 (PCM/Oxy2) are postoperatively treated witch CR~     oxycodone 10 mg orally twice a day for 48 hours. All patients also receive paracetamol 1000~     mg orally four times a day for 48 hours postoperatively.~      Recovery after discharge will be assessed using a diary for up to 48 hours after surgery.~     Three times a day, patients have to rate pain at rest and movement (VAS), fatigue, nausea,~     vomiting, pruritus, miction problems, pyrosis, and abdominal complaints. Furthermore,~     compliance to the use of the study medication will be assessed by checking whether the~     patients took the study medication as prescribed and if any other pain medication was used.~     Compliance will be assessed three times a day and patients will be divided into three groups~     according to medication use: always = full compliance, sometimes = partial compliance, or~     never = no compliance.~      Finally, overall satisfaction with the postoperative pain treatment will be assessed (score~     0-10).~   "
108093|NCT02152579|"~     Phase III clinical study for the evaluation of clinic and cardiologic effects of isosorbide~     mononitrate from the incidence of events (angina episodes).~      This is an open, comparative, monocentric trial. The hypothesis, regarding the number of~     angina episodes, to be tested are:~        -  H0: μD = 0 ot H0: μAfter = μBefore~        -  HA: μD ≠ 0 ot HA: μBefore ≠ μAfter~   "
108094|NCT02152566|"~     Respiratory insufficiencies during sleep can lead to reductions in the level of oxygen in the~     blood during the night, which has been shown to contribute to a range of morbidities.~      The purpose of this study is to assess the possibility that a nasal high flow therapy device~     may be able to treat respiratory insufficiencies, by stabilizing breathing and preventing~     reduction in blood oxygen.~      Heart failure patients will be screened at a heart failure clinic, and will be asked to~     undergo an overnight sleep study to determine is they exhibit respiratory insufficiencies~     during sleep. This sleep study may be completed in the sleep laboratory (attended~     polysomnography, PSG) or in-home (in-home polygraphy, PG). If they are diagnosed with~     respiratory insufficiencies, they will be asked to attend further overnight studies to see if~     treatment with nasal high flow therapy can be used to stabilize breathing.~   "
109798|NCT02130258|"~     The investigators hypothesize that there may exist different quantitative sensory profiles~     between radicular pain patients who respond and those who do not respond to the standard~     therapy of epidural steroid injections (ESI).~   "
108095|NCT02152553|"~     The investigators have shown that patients with adrenal insufficiency (Addison's disease), a~     rare disorder, have doubled the expected mortality rate in Sweden despite Standard of Care~     glucocorticoid (GC) replacement. One % of the Swedish population are, however, receiving GCs~     for inflammatory diseases, but management is empirical and adjusted to underlying disease~     activity. The desired anti-inflammatory therapeutic effects cannot be differentiated from the~     adverse metabolic (osteoporosis, obesity, diabetes mellitus) and immunosuppressive side~     effects of GC. This frequently results in suboptimal GC therapy with adverse effects due to~     over-dosing or poor efficacy due to under-dosing. The primary aim is to identify a biomarker~     for the metabolic effects of GCs. Patients with Addison's disease completely lack endogenous~     GCs and can therefore be considered a human GC knock-out model. They can therefore be studied~     during near-physiological exposure and during GC starvation. This will uniquely allow a very~     clean biomarker identification model (using transcriptomics, proteomics and metabolomics).~     The secondary aim is to validate candidate biomarker(s) in a dose-response study using the~     same patient population. A biomarker of GC actions will make it possible to individualised~     therapy during pharmacological GC treatment. It would allow GC replacement to be monitored in~     Addison's disease and could become a specific diagnostic tool in patients with GC deficiency~     and excess (Cushings syndrome).~   "
108096|NCT02152540|"~     This project will study 40 Veterans identified with symptoms understood to characterize mild~     to moderate Traumatic Brain Injury (TBI) including Post Traumatic Stress Disorder (PTSD).~     Following screening and informed consent, Veterans will be randomly assigned to treatment~     with repetitive Transcranial Magnetic Stimulation (rTMS) or sham rTMS (placebo). Additional~     examinations will compare brain imaging (structural and functional MRI scans at rest) across~     participants at baseline, after acute rTMS treatment, and at 6 month followup. The VA~     population differs significantly from populations that have been included in prior trials of~     rTMS for many conditions such as depression, chronic pain, and PTSD. Many returning Operation~     Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) personnel and Veterans with concussion~     histories report cognitive problems, such as impaired attention, verbal fluency, poor~     planning, reduced working memory, and mental flexibility. The investigators hope to show the~     efficacy and durability of rTMS in treating these symptoms safely in Veterans with~     co-morbidities.~   "
108097|NCT02152527|"~     Trimetazidine (1-[2,3,4-trimethoxybenzyl] piperazine dihydrochloride) is a clinically~     effective antianginal agent. Despite these clinical successes, the understanding of~     trimetazidine's mechanism of action remains incomplete, particularly influence of~     trimetazidine on mitochondrial function in isolated human cardiomyocytes. The investigators~     will perform this study to seek possible differences in mitochondrial respiration related to~     standard preoperative enrolled trimetazidine therapy.~   "
108098|NCT02152514|"~     The purpose of the study is to determine if the administration of a mix of Sufentanil and~     Morphine in intrathecal is a better analgesia regimen than PCA alone in patient post-VATS.~   "
108099|NCT02152501|"~     The purpose of this study is to research the effects of exercise on calories eaten and~     expended. The investigator expects to find out whether subjects change their eating and~     activity behaviors when starting an exercise program.~   "
108100|NCT02152488|"~     Rotation or flexion of the cervical spine is unavoidable during positioning for some surgical~     procedures as carotid endarterectomy, thyroidectomy and surgery of the shoulder. Rotation or~     flexion may reduce blood flow in the carotid or vertebral arteries and induce intraoperative~     cerebral ischemia with impact on the neurological outcome of surgery. Predominantly if the~     circulus willisii is incomplete because of congenital variation, collateral arteries may not~     be sufficient to compensate reduced blood flow in one carotid or vertebral artery. This may~     be aggravated by intraoperative hypotension in limits tolerable under normal conditions but~     fatal during impairment of vascular conductivity by positioning. The middle cerebral artery~     (MCA) is a final large scale pathway of cerebral blood flow and hence relevant reduction of~     flow in the MCA may serve as a surrogate parameter for relevant reduction of cerebral blood~     flow caused by carotid stretching or narrowing.~      Objective of this study is to investigate, if MCA blood flow in normal male and female~     subjects, aged 18 to 85 years, is reduced in extended and rotated cervical spine position in~     comparison to neutral position.~   "
108101|NCT02152475|"~     Photodynamic therapy (PDT) is a technique used for the oral disinfection. In dentistry, PDT~     for microbial inactivation may reduces both dental plaque and risk of developing caries as~     well as contributes to treat gingivitis, periodontitis, peri-implantitis and endodontic~     diseases. The investigators hypothesis was that PDT with blue light and curcumin promotes~     oral disinfection during 2 hours after treatment.~   "
108102|NCT02152462|"~     Overview: This is a 6 month, two-arm randomized clinical trial using comparing exergaming to~     a control group. The investigators will randomize Black sedentary overweight/obese women to~     Wii Fit exercise (n=50) or the control arm (n=50). Women in the Wii Fit exercise group will~     come to the Georgetown community-based exercise facility 3 days/wk. The control group will be~     asked to maintain their current daily activities and not to exercise for the duration of the~     study. Based on the investigators previous findings that women who engage in 75-150 mins/wk~     of brisk walking had an 18% decreased risk of breast cancer, the investigators will target~     this level of activity in the investigators intervention arm. Also, this 150 min/week of~     physical activity meets the current recommendations of the American College of Sports~     Medicine (ACSM) and the US Department of Health and Human Services for healthy individuals~     and is in line with recommendation of the American Cancer Society (ACS) for cancer~     prevention.~   "
108103|NCT02152449|"~     The purpose of this study is to determine whether an early oral nutritional supplementation~     (ONS) in amyotrophic lateral sclerosis (ALS) patients is effective on the treatment of this~     rapidly progressive disease.~   "
108104|NCT02152436|"~     Communication in the operating room (OR) is a key factor to prevent deleterious events for~     the patient. French national health authority made the implementation of safety checklist~     mandatory in operating rooms. The goal of this checklist is to improve teamwork and share key~     elements for better patient outcomes. Observational studies in the OR showed low compliance~     to this checklist, either on the way it is used or on the information implemented.~      The primary objective of this project is to assess the efficacy of a simulation-based~     curriculum involving OR medical and non-medical personnel in order to improve communication~     in the OR.~   "
108105|NCT02152423|"~     Because of their anti-Xa and ease of administration activity, the Low molecular weight~     heparin represent an attractive alternative to the unfractionated heparin. Several clinical~     trials have demonstrated that Low molecular weight heparin was more effective than~     Unfractionated heparin without increasing bleeding complications. Enoxaparin has been the~     most studied. Its use is recommended.~      Demonstrate that Enoxamed® is comparable to that of Lovenox® in the anti-Xa activity action.~   "
108106|NCT02152410|"~     Renal colics are a common cause af acute intense pain in medical emergency settings requiring~     often the use of high level antalgics (opioid) to relief the patient.~      In the other hand, Acupuncture is well known widely for its therapeutic characteristics,~     especially in relieving pain.~      the aim of these study is to compare this two pain relieving techniques in patients~     consulting the emergency departement (ED) for acute onset renal colics.~   "
108107|NCT02152397|"~     Use of opioid medications for treatment of pain has increased greatly in the U.S., with the~     average quantity of prescribed opioids increasing 700% in a decade, from ~100 morphine~     milligram equivalents (MME) per person to ~700 MME per person from 1997 to 2007. There have~     been concurrent increases in opioid-related adverse outcomes, such as extramedical use,~     opioid use disorders, and overdose. As a result, there were more unintentional poisoning~     deaths than deaths due to motor vehicle crashes among adults in 2010 (32,723 vs. 32,640).~     Additionally, the number of Americans seeking treatment for opioid use disorders has~     increased; in SAMHSA's Treatment Episode Data Set, prescription opioids were the primary~     substance of abuse for 142,782 individuals in 2009, compared to 22,637 in 1999, a 530%~     increase.~      The specific aims of this project are to: (1) Refine a motivational enhancement prevention~     intervention for prescription opioid overdose risk reduction and improved witnessed overdose~     response for at-risk patients in addictions treatment; (2) Conduct a pilot randomized~     controlled trial comparing the prescription opioid overdose prevention intervention to a~     supportive educational control condition for patients in addictions treatment in order to:~     (a) obtain information about the feasibility of randomized controlled procedures; and (b)~     determine the distribution and variability of the primary (overdose risk behaviors) and~     mediating/secondary (witnessed overdose response, self-efficacy to reduce overdose risk,~     knowledge of overdose risk factors and symptom recognition) outcomes; and (3) Determine the~     distribution and variability in changes in HIV risk behaviors (e.g., reductions in injection~     of prescription opioids) over follow-up.~   "
108108|NCT02152384|"~     This study will look into how a base dose of insulin peglispro and insulin glargine will~     affect the meal time dose and efficacy of insulin lispro in type 1 diabetics. This study is~     expected to last up to 17 weeks.~   "
108109|NCT02152371|"~     The main purpose of this study is to evaluate the use of the study drug known as dulaglutide~     in participants with type II diabetes who are taking once-daily insulin glargine. The study~     will last about 31 weeks for each participant.~   "
108110|NCT02152358|"~     The aim of this study is to show that a preemptive treatment by ganciclovir (for positive CMV~     viremia) or aciclovir (for positive HSV oro-pharyngeal PCR) is able to increase the number of~     ventilator-free days at Day 60.~   "
108111|NCT02152345|"~     The main purpose of this study is to ﬁnd out whether treatment to prevent kidney rejection~     with belatacept in presence of Thymoglobulin induction and withdrawal of steroids will result~     in less delayed graft function or sleepy kidney after transplant than that seen in patients~     who get tacrolimus as their main drug to prevent rejection instead of belatacept. The~     investigators will also look at whether patients who get belatacept have the same, lesser or~     more problems that those who get tacrolimus.~   "
108112|NCT02152332|"~     The purpose of this study is to evaluate the effects of JNJ-54861911 on the QT/QTc intervals~     in healthy participants, when administered at therapeutic (50 milligram [mg] once-daily) and~     supratherapeutic (150 mg once-daily) doses for 7 days.~   "
108113|NCT02152319|"~     The objective is to clinically assess the Kinesia HomeView system for automated and remote~     monitoring of Parkinson's disease (PD) motor symptoms.~   "
108114|NCT02152306|"~     The aim of this study is to ensure the superiority of Fimasartan/Amlodipine combination in~     hypotensive effect after 8 weeks of treatment over Fimasartan monotherapy in patients with~     hypertension who have no response to Fimasartan 60mg monotherapy.~   "
108115|NCT02152293|"~     The purpose of this study is to assess, in real life, the efficacy and the eligibility for~     discharge of a local anesthetic, CLOROTEKAL®, used for spinal anesthesia in short outpatient~     surgery.~   "
108116|NCT02152280|"~     Research topic.~        -  A clinical trial of Danhong injection in treating acute ischemic stroke .~      Research purpose.~      - To evaluate the efficacy and safety of Danhong injection in treating acute ischemic stroke~     by a randomized, double-blind, multi-center, placebo-controlled clinical trial.~      Research design.~      - A randomized, double-blind, multi-center, placebo-controlled clinical trial.~      Subject crowd.~      - Accord with standard of western medicine diagnosis of acute cerebral infarction, stroke and~     blood stasis type of traditional Chinese medicine syndrome differentiation.~      Sample size. - Total sample size of 320 patients, experimental group, control group is equal~     to 1 to 1.~      Interim analysis.~      - Interim analysis will be performed when the total number of included patients up to half of~     the sample size ,160 cases, and according to the interim analysis results to estimate the~     sample size and adjust the project adaptively.~      Course of treatment.~      - 10 days.~      Research endpoint.~      - The 90th day after the medication for the first time.~      Observation index.~        1. General condition; the physical and chemical inspection related;~        2. Efficacy check : mRS, BI, NIHSS;~        3. Safety check: blood routine, urine routine, stool OB, liver function(ALT、AST), renal~          function (BUN, Cr), coagulation four indices（PT、APTT、TT、FIB), electrocardiogram.~      Efficacy evaluation. 1. The main efficacy index: a. Percentage comparisons of two group~     patients of modified Rankin 0-2 grades on the 90th day.~      Statistical analysis technique.~      - Statistical analysis using SAS 9.2 system, all the statistical test adopted bilateral~     inspection, P value less than or equal to 0.05 will be considered a statistically significant~     difference.~   "
108227|NCT02150824|"~     Assess the safety and tolerability of once daily oral doses of BI 187004 in patients with~     type 2 diabetes mellitus without oral antidiabetic treatment and in patients on a stable~     metformin background treatment over 28 days. Assess the effect on fasting plasma glucose~     after 28 days of treatment and to investigate the pharmacokinetics and pharmacodynamics of BI~     187004.~   "
108117|NCT02152267|"~     1. BACKGROUND: Temporomandibular Disorders (TMD) have become part of the daily routine of~          all the health care professionals. Some studies have shown improvement in subjects with~          chronic pain using neuromodulation. Chronic pain is involved with neuronal excitability~          and the excitatory modulation is also being studied to treat chronic pain. Transcranial~          direct current stimulation (tDCS) allows the neuronal membranes to be neuromodulated.~          tDCS can enhance or inhibit the potential actions on the cortex. Studies with animals~          has shown that anodal stimulation modulate the membrane in the way to depolarize which~          results in a long term potential in the stimulated area.~        2. PROBLEM: Most strategies for the treatment of TMDs are local and aim to treat directly~          the cranial-facial muscles, applying kinesitherapy on Temporomandibular joint (TMJ)~          and/or on the jaws and on the occlusion of teeth. Some drugs, such as tricyclic~          antidepressants, that act in the CNS are used in these patients with positive results in~          the beginning of the treatment. However, many patients after using these drugs in a~          daily basis, are refractory to them and do not present an improvement in the pain~          anymore or present several side-effects. Therefore, the investigators want to know if~          tDCS over dorsolateral prefrontal cortex (DLPFC) would have an analgesic effect when~          reaching emotional areas.~        3. HYPOTHESIS: The investigators believe that neuromodulation by tDCS over DLPFC would~          decrease the anxiety level and consequently the muscular hyperactivity that is an~          important etiological factor of TMD. For that, the masseter motor evoked potential (MEP)~          will be used to verify any change.~        4. AIM: To investigate if cathodal tDCS over right DLPFC has analgesic effects in subjects~          with muscular TMD.~        5. METHOD: The investigators will run a three-arm crossover double blind with 15 muscular~          TMD subjects. The group treatments will be cathodal tDCS 1mA, cathodal tDCS 2mA and~          Placebo. To verify selection criteria the investigators will use RDC/TMD, Visual~          analogical scale (VAS) score from 4 to 10 for six months or longer, Inventory of~          state-trit anxiety (ISTA) score more than 42. The outcomes will be VAS, sensory testing,~          Electroencephalogram (EEG) and ISTA.~   "
108118|NCT02152254|"~     You are being asked to take part in this study because you have metastatic cancer (cancer~     that has spread to other parts of the body).~      Cancer can be caused by abnormalities in genetic material (such as gene mutations). These~     genetic differences can be found by studying the tumor (molecular profiling). Information~     from molecular profiling can be used to choose treatment that may target the tumor. This is~     known as personalized medicine. Early studies have shown that molecular profiling has led to~     patients being treated with more specialized therapy than they would normally receive. At~     this time is it unknown whether molecular profiling and selection of treatment has different~     results than standard-of-care treatment.~      The goal of this research study is to compare the effects of treatment based on molecular~     profiling to those of the standard-of-care.~      This is an investigational study.~      Up to 1,362 participants will take part in this study. All will be enrolled at MD Anderson~     and its regional care centers.~   "
108119|NCT02152241|"~     Inflammatory bowel diseases (IBD) are group of immune system disorders characterized by a~     chronic course with remission and relapses. Canada is one of the countries with the highest~     prevalence and incidence rates of IBD with 25% of patients present in children and~     adolescents.~      As with any chronic illness, IBD diagnosed early in life has a significant impact on the~     physical, emotional and social development of those affected. Consequently, it is logical to~     speculate that patients with IBD may not do as well in education levels or employment status~     attained compared to their peers without IBD. If this were the case, then interventions could~     begin in childhood to better prepare patients with IBD for the challenges of living with a~     chronic disease. Alternatively, if it is shown that they reach comparable social or~     employment milestones as adults compared to unaffected peers then this would be enormously~     reassuring to children and their parents.~      Properly designed studies to help in defining more appropriate interventions to these~     patients are needed.~      The proposed study includes circulating a survey to evaluate the functioning level of adult~     patients with IBD who were diagnosed during their childhood. The participants will be asked a~     series of questions regarding their highest level of educational achievement, the nature of~     their current employment, and their current marital status. The question format will parallel~     that of the Canadian Community Health Survey from which data from an age matched healthy~     adult Manitobans will be extracted and used as another control group. Responses will be~     analysed for any possible differences between these groups.~   "
108120|NCT02152228|"~     This is an observational, international, open label, pilot study to evaluate the safety,~     tolerability and efficacy of an oral PTH (1-34) preparation produced by Entera Bio in adult~     hypoparathyroid volunteers.~   "
108121|NCT02152215|"~     The purpose of this study is to compare the clinical and histologic outcomes for acellular~     dermal matrix and resorbable membranes to determine if either provides a significant~     therapeutic advantage.~   "
108122|NCT02152202|"~     Our main objective is to perform an explanatory, first stage proof of concept, randomized~     controlled trial to determine whether a semi-upright patient position versus a supine~     position while asleep in the postoperative period helps decrease the worsening of AHI in~     patients diagnosed with OSA and compare this to usual care (i.e. supine patient positioning~     while asleep).~      The investigators will evaluate whether a semi-upright position reduces: worsening of AHI (as~     measured with a portable PSG) on the second postoperative night (POD2); oxygen desaturation~     index (using a portable oxygen saturation monitor, oxygen desaturation defined as >4% change~     below baseline lasting for 10 seconds); REM sleep related change in AHI at baseline and~     POD2.; major and minor perioperative complications on postoperative day POD1, POD2, at~     discharge and POD 30.; length of hospital stay and readmission within 30 days; and patient~     satisfaction score on POD30~   "
108123|NCT02152189|"~     The purpose of this study is to assess the frequency of Fabry disease in children with~     chronic abdominal pain or chronic pain in the extremities~   "
108124|NCT02152176|"~     Intense acute pain is a common reason for Emergency admittance and its management is one of~     the major public health goals.~      In the recommendations formalized experts, it is recommended to use a protocol titration with~     morphine bolus of 2 mg (for patients less than 60 kg) or 3 mg (for patients over 60 kg)~     repeated every 5 minutes with a target of the Visual Analog Scale less than or equal to 30.~      Despite these specific recommendations and a broad awareness of the teams, management of pain~     remains to be improved, the major difficulty of morphine titration at the emergency~     department being the availability of paramedical personnel to perform revaluations and~     reinjection. Thus, effective analgesia would be obtained in 50% of cases to 30 minutes.~      The investigators want to study the self-controlled morphine titration by the patient by a~     mechanical device for single use (efficacy/safety).~   "
108157|NCT02151747|"~     Testing BRCA 1/2 mutation is important for patients with breast cancer, and Sanger sequencing~     is a standard method to identify BRCA 1/2 mutation. Next generation sequencing (NGS) is a~     high-throughput parallel sequencing that can provide genetic information with high accuracy.~     NGS is a faster and cost-effective method to detect gene mutations compared to Sanger~     sequencing. In this study, we evaluated the clinical role of NGS testing for BRCA 1/2~     compared to Sanger sequencing.~   "
108125|NCT02152163|"~     STUDY OBJECTIVES:~        1. To evaluate the effectiveness of around the clock (OTC) IV ibuprofen (8 doses) in~          decreasing pain in orthopedic trauma patients with fractures of the extremities, face,~          pelvis and/or ribs compared to patients not receiving the medication.~        2. To evaluate the effectiveness of around the clock (OTC) IV ibuprofen (8 doses) in~          decreasing the use of opioid analgesics among orthopedic trauma patients with fractures~          of the extremities, face, pelvis, and/or ribs compared to compared to patients not~          receiving the medication.~   "
108126|NCT02152150|"~     The objective of this study was to evaluate the efficacy of iron bio-fortified pearl millet~     in improving iron status in adolescents in India.~   "
108127|NCT02152137|"~     This phase II trial studies how well inolitazone dihydrochloride (efatutazone~     dihydrochloride) and paclitaxel work in treating patients with anaplastic thyroid cancer that~     has spread to other places in the body and usually cannot be cured or controlled with~     treatment (advanced). Drugs used in chemotherapy, such as efatutazone dihydrochloride and~     paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading.~   "
108128|NCT02152124|"~     Acromegaly is a rare hormonal disorder leading to increased morbidity and mortality. In the~     vast majority of cases, a pituitary somatotroph cell adenoma causes excess growth hormone~     (GH) secretion, leading to hepatic insulin-like-growth factor 1 (IGF-1) hypersecretion. Both~     the disease as well as its treatment with long-acting somatostatin analogs (LA-SMSA) and/or~     pegvisomant affect glucose and lipid metabolism, possibly contributing to increased~     cardiovascular risk.~      In this pilot study, the investigators want to explore insulin sensitivity, postprandial gut~     hormone response, lipid handling and adipocytokine profile in the following 4 groups:~        -  controlled acromegalic patients on LA-SMSA (group 1)~        -  controlled acromegalic patients on combination treatment of LA-SMSA and pegvisomant~          (group 2)~        -  acromegalic patients without need for medical therapy after surgery (group 3)~        -  healthy control subjects (group 4)~      Furthermore, a longitudinal exploration will be performed in uncontrolled acromegalic~     patients (i.e. patients with serum IGF-1 levels above age-specific thresholds and/or symptoms~     due to active acromegaly (excessive sweating , arthralgia)) on LA-SMSA monotherapy (group 5).~     In this group, insulin sensitivity, postprandial gut hormone response, lipid handling and~     adipocytokine profile will be explored before introducing pegvisomant and three months after~     normalisation of IGF-1 levels.~      The investigators hypothesize that lipid and glucose handling will be less efficient in the~     controlled acromegalic patients on LA-SMSA than in controlled patients on combination therapy~     or after surgery, and that there will be no difference in substrate metabolism between~     healthy controls and controlled acromegalic patients on combination treatment or after~     surgery. Further, they hypothesize that introducing pegvisomant in uncontrolled acromegalic~     patients will improve their postprandial lipid and glucose handling.~   "
108129|NCT02152111|"~     This study aimed to evaluate the effect of weight loss with diet combined coconut flour~     consumption improvement weight loss and reduction in glucose, cholesterol in obese women.~   "
108130|NCT02152098|"~     Firstly, the investigators aim to study the biochemical, structural and functional changes~     associated with acute muscle strain injury in the acute phase and during rehabilitation in~     vivo. Specific factors present after the injury and their effects on connective tissue cells~     will be examined in vitro.~      Secondly, the investigators will investigate individuals with chronic pain, scar tissue and~     inferior function after a previous muscle strain injury and test a specific rehabilitation~     program to alleviate pain and disabilities associated with the preceding muscle injury. The~     investigators have the following hypotheses:~        1. Humoral growth factors and pro-inflammatory macrophages released into the injured area~          post strain injury stimulate formation of connective tissue in vitro.~        2. Early onset of rehabilitation will be superior to a delayed start of rehabilitation for~          the healing process, in regards to structural improvement of tissue and better clinical~          function.~        3. Scar tissue following a muscle strain injury is characterized by disorganized structure~          of connective tissue.~        4. Mechanical loading in the form of heavy eccentric muscle activity for 12 weeks will lead~          to a local re-modeling of scar tissue, and result in improved function and reduced~          symptoms in patients with chronic pain and impaired function after a previous muscle~          injury.~   "
108131|NCT02152085|"~     The purpose of this study is to investigate the capacity of a 6-week treatment with~     neuromuscular electrical stimulation to improve walking in individuals whose mobility has~     been compromised by multiple sclerosis.~   "
108132|NCT02152072|"~     Dyspnea is a common symptom encountered frequently by medical practitioners. The differential~     diagnosis for a patient with such a symptom is broad and time consuming, while immediate~     management for distressed patients is what is desired. Lung ultrasound (LUS) is a relatively~     new technique that will help physicians more accurately diagnose and manage patients who~     present with dyspnea.~      Focused medical ultrasonography education is becoming integrated into many physician~     residency training programs. Recent studies indicate a possible relationship between focused~     ultrasonography training in medical school curricula and improved physical examination~     accuracy. Thus, a short-term training program in LUS during medical school will have a major~     impact on physicians to be comfortable in using this skill when dealing with distressed~     patients in their prospective residency training. It will reduce educational burdens for~     physician residency programs and improve overall physician competency.~      Simulation-based medical education (SBME) is ideally suited for offering effective training~     in a zero-risk environment. It enables trainees to gain knowledge and confidence in dealing~     with stressful clinical scenarios without exposing patients to any additional risk. SBME has~     also been shown to be a reliable tool for assessing learners' procedural skills and for~     teaching topics such as teamwork and communication.~      The investigators hypothesize that simulation-based training of medical students will enable~     them to more effectively evaluate patients with shortness of breath using LUS.~   "
108133|NCT02152059|"~     This study is being done to evaluate the good and bad effects of BIBF1120 in recurrent,~     platinum-sensitive small cell lung cancer patients and to see if BIBF1120 may or may not be~     more effective and better tolerated than standard therapy.~      The purpose of this study is to:~        -  Find out the proportion of patients with their small small cell lung cancer controlled~          for at least 90 days after treatment with BIBF1120~        -  Compare the response rate, survival and side effects of BIBF1120 in recurrent,~          platinum-sensitive small cell lung cancer patients~        -  Identify a group of patients who will benefit the most from BIBF1120 In this study,~          patients will receive BIBF1120 at 200 mg twice daily continuously. A cycle will be 21~          days. During treatment, the dose of BIBF1120 will be held or reduced to lower doses if~          patients do not tolerate it well or if the doctors are concerned about the side effects~          of BIBF1120 on individual patients.~   "
108228|NCT02150811|"~     The purpose of this study is to observe change of distribution pattern of Hunner's ulcer in~     patient with interstitial cystitis/bladder pain syndrome~   "
108134|NCT02152046|"~     Retinopathy of prematurity (ROP) is a major cause of blindness in the world. Initial ocular~     examinations of infants at risk for ROP are generally conducted between 4-6 weeks~     postnatally. These exams are vital to protect preterm infants from blindness, but these exams~     have been shown to cause pain in this population.~      Currently two speculums are utilized; the spring loaded Alfonso and the screw loaded Cook~     eyelid speculum. There is no schedule for who receives which speculum during their exam.~      The objective of this study is to evaluate the pain response in the neonatal population, 32~     weeks or less, and less than or equal to 1500 grams, undergoing a retractor eye exam for~     retinopathy of prematurity (ROP) screening.~      The primary study aim is to compare the N-PASS pain score between neonates who received a ROP~     eye exam with the spring loaded Alfonso and the screw loaded Cook eye speculums.~   "
108135|NCT02152033|"~     The purpose of this project is to develop and test a Home-based Continuing Care intervention~     that will help parents support the recovery of their Young Adult (YA) child who is leaving~     residential substance abuse treatment. The two phase pilot study will 1) interview 50 parents~     and 50 YAs recruited from residential treatment programs and from parent groups to inform the~     development of the intervention and 2) conduct a two-arm pilot study that will recruit a~     maximum of 20 parents and their young adult children into one of two conditions (Home-based~     Continuing Care [HCC] intervention group or Services as Usual [SAU] comparison group) with~     the main goal of determining whether conducting such an intervention is acceptable and~     sustainable, and to collect preliminary efficacy data. We hypothesize that pilot testing will~     indicate that: (a) HCC is acceptable and potentially sustainable; (b) conducting a randomized~     clinical trial is feasible, and (c) the magnitude of outcomes from HCC will be clinically~     meaningful.~   "
108136|NCT02152020|"~     The objective of this study is to find out if acupuncture can improve the management of pain~     in cancer patients when used as part of a treatment plan that includes conventional pain~     medications. The investigators will enroll 36 cancer patients at Abramson Cancer Center and~     Penn Cancer Network sites. Participants will be enrolled in either the Conventional Pain~     Management group or Integrative Pain Management group.~   "
108137|NCT02152007|"~     A study to evaluate safety and efficacy of topical sirolimus to treat plantar keratoderma in~     adults with PC. Subjects may receive either placebo or treatment with at least 1 foot~     receiving topical sirolimus at some time. For certain phases of the study treatment~     assignment to the right and left foot will be randomized in a double blind fashion. Blood~     levels will test systemic absorption of sirolimus. Other safety and efficacy measures will be~     taken through the 39-week study duration. Funding Source - FDA OOPD~   "
108138|NCT02151994|"~     The purpose of this study is to to assess the safety and tolerability of BIA 5 1058 after~     single and multiple oral doses~   "
108139|NCT02151981|"~     A Phase III, Open Label, Randomized Study of AZD9291 versus Platinum-Based Doublet~     Chemotherapy for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer~     whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase~     Inhibitor Therapy and whose Tumours harbour a T790M mutation within the Epidermal Growth~     Factor Receptor Gene~   "
108140|NCT02151968|"~     Eye surgeries are traditionally performed under local anaesthesia with a peribulbar block.~     This is a blind technique where local anaesthetic is injected into the back of the eye to~     make the eye numb and motionless for surgery. This is a blind injection and can be associated~     with complications such as bleeding, rupture of eye globe, blindness, increasing the pressure~     of the eye etc. It also has a high failure rate resulting in need for additional injections,~     further exposing the patient to possible complications. The investigators propose to perform~     the peribulbar block with ultrasound to guide the block needle placement and injection. The~     investigators hypothesize that ultrasound guided peribulbar blocks would have higher success~     rate (less need for additional injections) and that the total amount of local anaesthetics~     used would be decreased.~   "
108141|NCT02151955|"~     Following an exploratory project, funded by Guys and St Thomas' Charity between September~     2010- November 2011, of the first combined mental health screening and intervention project~     for <5 Children in Care (CiC) in the UK, the current study will expand this work by a)~     developing a feasibility study to assess both longer term interventions and outcomes for this~     group and b) extending the model to two further vulnerable groups of young children.~      The three groups of children aged 3 months to 3 years (<4's) in Southwark include:~        1. Children who become newly looked after (CiC)~        2. Children of parents referred to Parental Mental Health team (PMH)~        3. Children on Child Protection (CP) Plans~      Parents will be invited to take part in the study if their children are eligible within the~     groups above. Informed consent will be obtained at the outset.~      Hypothesis;~      The investigators aim to implement a method of screening that will identify socioemotional~     and mental health needs in infants and young children, aged 0-3 years of age, across three~     high risk cohorts (Children in Care, children on a Child Protection Plan, children of parents~     with mental health difficulties).~      Is it feasible to deliver an early treatment intervention that positively impacts on the~     difficulties identified, by providing specific emotional, social and mental health support~     and advice to the child's current caregivers in relation to the child.~   "
108142|NCT02151942|"~     The purpose of this study is to evaluate the procedural and clinical benefits of patient~     specific pre-procedure rehearsal for operators with various experience levels as a tool for~     optimizing Endovascular Aneurysm Repair (EVAR) procedures.~   "
108143|NCT02151929|"~     Evaluation of the feasibility and safety of Bioresorbable Vascular Scaffold (BVS) in patient~     treated with primary PCI (pPCI).~   "
108158|NCT02151734|"~     This is a multi-center, double-dummy, double-blind, randomized, active-controlled, parallel~     group phase 3 clinical trial to evaluate the efficacy and safety of KALOMIN™ Tab. in patients~     with acute bronchitis.~      The aim of this clinical trial is to demonstrate that KALOMIN™ Tab. is clinically~     non-inferior to Umckamin syrup, as assessed by BSS(Bronchitis Severity Score), in the~     treatment of acute bronchitis after 7 days.~   "
108293|NCT02149966|"~     This is a dose escalation study that will be conducted in healthy volunteers. Multiple~     cohorts of volunteers will receive ascending (increasingly higher) oral doses of AG-348 daily~     for 14 days to evaluate the safety and tolerability of multiple oral doses of AG-348, the~     pharmacokinetics (PK) of multiple doses of AG-348, and the pharmacodynamic profile of AG-348~     with specific biomarkers assessed in the blood.~   "
108144|NCT02151916|"~     The purpose of this study is to determine whether a combination of pre- and post-natal~     preventive and behavioral interventions is effective in preventing early childhood caries in~     Indigenous children.~      Early childhood caries (ECC) causes profound suffering, frequently requiring expensive~     treatment under a general anesthetic. It is associated with other chronic childhood~     conditions such as otitis media and nutritional disorders, and is the strongest predictor of~     poor oral health in adulthood. Despite ECC being entirely preventable, marked ECC disparities~     exist between Indigenous and non-Indigenous children in Australia, New Zealand and Canada. If~     the burden of ECC and associated oral health inequalities experienced by Indigenous children~     in these nations are to be reduced, more needs to be done to ensure that appropriate~     preventive measures, together with support for maintaining optimal oral health, are provided~     to caregivers of such children in the early life stages. This will be an interventional~     study, with all participants receiving the intervention benefits. Pregnant Indigenous women~     residing in the three countries, their families and communities will be included. The~     intervention will be implemented from birth and continue for the first three years of a~     participating child's life. It will involve four components; dental care provided to the~     mother during pregnancy, fluoride varnish applications for the child, oral health~     anticipatory guidance and motivational interviewing. Following an Indigenous research~     framework and methodology, the intervention will be tailored at the individual- or~     family-level, with each caregiver or family progressing to the next level only when they are~     ready. Developing a culturally-appropriate ECC intervention that aims to improve child oral~     health, in full partnership with the Indigenous communities involved, will provide much~     needed evidence for policy makers to address the challenge of improved oral health and~     related outcomes for Indigenous children.~   "
108145|NCT02151903|"~     An open-label extension study enrolling patients experiencing clinical benefit following 6~     cycles of DI-Leu16-IL2 while enrolled in the Alopexx Oncology AO-101 study. Patients will be~     permitted to continue to receive DI-Leu16-IL2 at the same dose, schedule, and route of~     administration they received while on the parent protocol. Prior pre-treatment (e.g.~     Rituximab) will continue as before.~   "
108146|NCT02151890|"~     Out of 112 high risk patients for Premature Ovarian Failure (POF), diagnosis was established~     in 10 cases.~      ESS cut off point for menstruation and pregnancy was 6.~   "
108147|NCT02151877|"~     Around 7500 neonates born yearly in the United States have complex congenital heart disease~     that require surgical repair in the first few days of life. The complexity of the surgical~     repair requires long periods of cardiopulmonary bypass (CPB) and the use of intermittent~     periods of low flow or complete circulatory arrest. The immature neonatal vital organs are~     more prone to the complications of the cardiopulmonary bypass circulation, namely~     ischemia/reperfusion (I/R) injury and systemic inflammatory response. Inhaled nitric oxide~     (NO) is used frequently in neonates for the treatment of pulmonary hypertension,~     Additionally, many studies have shown that NO has an anti-inflammatory effect by reducing I/R~     injury and endothelial dysfunction.~      The purpose of this pilot study is to assess the efficacy of NO administration via the CPB~     circuit in attenuating the CPB induced I/R injury and systemic inflammatory reaction in~     neonates undergoing repair of complex congenital heart defects. Specific goals will be to~     demonstrate that NO use via CPB will:~        -  Decrease markers of I/R injury and systemic inflammatory response.~        -  Decrease platelet activation leading to reduced postoperative bleeding and transfusion~          requirements.~        -  Decrease postoperative organ dysfunction, and hence decrease operative mortality and~          postoperative morbidity.~      Twelve neonates undergoing repair of complex congenital heart defects will receive NO via the~     CPB circuit, for the duration of surgery. They will be compared to a control group of 12~     similar patients. Serum levels of different ischemic reperfusion injury and inflammatory~     markers will be measured at different time points after surgery and will be correlated with~     different end organ function tests and clinical course in the postoperative period. The~     results will be compared between the two groups to try to determine the clinical benefit of~     NO administration through CPB circuit.~   "
108148|NCT02151864|"~     The purpose of this study is to test the safety and determine the maximum safe dose of an~     experimental drug called LDE225 (hedgehog inhibitor) in people with liver cancer. We have~     identified hedgehog dysregulation as a novel mechanism for hepatocarcinogenesis and hepatic~     fibrosis/cirrhosis. Therefore, we hypothesize that the hedgehog inhibitor may be an ideal~     drug target for treating both hepatocellular carcinoma (HCC) and Child-Pugh A cirrhosis~     (CPA).~   "
108149|NCT02151851|"~     This study will evaluate the safety & efficacy of Certolizumab Pegol (CZP) as additional~     medication to Methotrexate (MTX) in Chinese subjects with Rheumatoid Arthritis. 400 patients~     will be randomized to receive either CZP + MTX or placebo + MTX. Anticipated time in the~     study is about 32 weeks.~   "
108150|NCT02151838|"~     To assess the safety and the efficacy of Highly Active Anti-Retroviral Treatment (HAART) for~     the Prevention of Mother-To-Child Transmission of HIV (PMTCT)~   "
108151|NCT02151825|"~     The purpose of this study is to investigate the effects of a synbiotic (ProSynbiotic) on the~     gut microbiota composition, body composition and adiposity-related genes and metabolic~     markers in healthy overweight adult subjects.~   "
108152|NCT02151812|"~     The primary objective of this study is determine the safety and performance of the Agent™~     Paclitaxel-Coated PTCA Balloon Catheter compared to the SeQuent® Please Paclitaxel-Releasing~     Coronary Balloon Catheter for the treatment of patients with narrowed previously-stented~     coronary arteries (in-stent restenosis).~      The performance will be determined at six months post-procedure by quantitative coronary~     angiography (QCA) to measure Late Lumen Loss (LLL) in the re-opened stented segment. QCA~     results will be assessed by an independent, blinded angiographic core lab.~      Study statistical hypothesis: The loss of in-stent luminal diameter at six months after~     treatment of the restenosed stent with the Agent™ study device is not larger than the~     respective LLL after treatment with the SeQuent® Please control devices, i.e. study device is~     non-inferior to the control device with respect to LLL.~   "
108153|NCT02151799|"~     The data regarding the effects of aesthetic body contouring is insufficient. Poor results may~     related to preoperative psychological distress. Studies regarding eating disorder symptoms~     are lacking. Therefore studies using standardized and validated are needed. We decided to~     prospectively study quality of life, psychological distress, and eating disorder symptoms in~     body contouring (abdominoplasty or liposuction) patient populations. Used questionnaires are~     15D quality of life, Raitasalo's modification of the Beck Inventory, and the Eating Disorder~     Inventory. We hypothesize that aesthetic body contouring plastic surgery has notable quality~     of life effects.~   "
108154|NCT02151786|"~     The purpose of this survey is to evaluate the safety (i.e., frequency of adverse events) and~     efficacy (i.e., hemostatic effect, rate of rebleeding after confirmation of hemostasis) of~     administration of lansoprazole intravenous 30 milligram (mg) (Takepron Intravenous 30 mg) to~     a large number of patients in daily medical practice.~   "
108155|NCT02151773|"~     The purpose of this survey is to assess the safety freeze-dried live attenuated measles and~     rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) (freeze-dried live attenuated~     measles and rubella combined vaccine Takeda) in terms of the occurrence of unknown/known~     adverse drug reactions and factors that may influence the safety of vaccinees after the first~     vaccination.~   "
108156|NCT02151760|"~     This study is being done to determine the safety, biodistribution, and radiation dosimetry of~     18F-DCFPyL, and to detect prostate cancer by visual analysis.~   "
146070|NCT01655160|"~     The purpose of this study will evaluate the long-term benefits, optimal dose and mechanisms~     of mirror therapy and its effects on physiological markers.~   "
108159|NCT02151721|"~     -  Gefitinib is an orally active epidermal growth factor receptor-tyrosine kinase inhibitor~          (EGFR-TKI). However, 20-30% of patients with EGFR-activating mutations show intrinsic~          resistance to EGFR-TKI.~        -  EGFR-mutant non-small cell lung cancer (NSCLC) cells with BIM (BCL2L11) deletion~          polymorphism show the impaired generation of BIM with the proapoptotic BH3 domain, as~          well as resistance to EGFR-TKI-induced apoptosis.~        -  Both BIM polymorphism (12.9%) and EGFR mutations (50% in lung adenocarcinoma) are more~          prevalent in the East Asian than in Caucasian populations. BIM is a BH3-only~          proapoptotic member of the Bcl-2 protein family. BIM upregulation is required for~          apoptosis induction by EGFR-TKI in EGFR-mutant NSCLC.~        -  Vorinostat (suberoylanilide hydroxamic acid [SAHA]) is a small-molecule inhibitor of~          histone deacetylase (HDAC) and induces cell differentiation, cell cycle arrest, and~          apoptosis in several tumor cells. HDAC inhibition can epigenetically restore BIM~          function and death sensitivity of EGFR-TKI in patients with EGFR-mutant NSCLC in whom~          resistance to EGFR-TKI is associated with a common BIM polymorphism. EGFR-TKI resistance~          due to the BIM polymorphism may be able to be circumvented in combination with HDAC~          inhibition of vorinostat with gefitinib in NSCLC.~   "
108160|NCT02151708|"~     Functional dyspepsia (FD) is a disorder characterized by chronic or recurrent upper abdominal~     pain or discomfort in the absence of a specific structural cause.1 Several mechanisms have~     been suggested to underlie dyspeptic symptoms. In a barostat study by Tack et al.2, impaired~     gastric accommodation to a meal was found in 40% of patients with FD, and this abnormality~     was associated with early satiety. Delayed gastric emptying (GE) was also found in almost 40%~     of patients with FD, and was associated with the symptoms of postprandial fullness, vomiting~     and early satiety.3-5 Improving gastric accommodation and prokinetic effect seem to be an~     attractive physiological target in patients with FD. Motilitone (Dong-A ST, Yongin, Korea) is~     a new herbal drug that was launched in December 2011 in Korea for treating patients with FD.~     It has multiple mechanisms of action such as fundus relaxation, visceral analgesia and~     prokinetic effects.6 The current study aims to evaluate effects of motilitone on gastric~     emptying and accommodation after a meal in patients with FD using three-dimensional gastric~     volume measurements by magnetic resonance imaging (MRI). Patients are randomly allocated to~     receive either motilitone 90 mg daily, motilitone 180 mg daily or placebo in a double blinded~     manner. After 2 weeks of treatment, patients undergo gastric MRI. The primary endpoint is~     gastric emptying rate. The secondary endpoints are gastric accommodation and symptom~     improvement.~   "
108161|NCT02151695|"~     Proliferative diabetic retinopathy is a serious complication of diabetes mellitus, partly~     consecutive to upregulation of vascular endothelial growth factor (VEGF) as a consequence of~     retinal ischemia leads. Aflibercept has been approved by FDA and European medicine agency for~     treatment of exudative age-related macular degeneration, another retinal disease~     characterized by choroidal new vessels.~      The aim of this pilot study is to evaluate the efficacy and the safety of Aflibercept~     intravitreal injections compared to panretinal photocoagulation for proliferative diabetic~     retinopathy.~   "
108162|NCT02151682|"~     Tapentadol has already been studied in adults. This study is needed to find out if tapentadol~     works and is safe to use in children and adolescents with long-term pain.~      During the first 2 weeks of the study (Part 1), participants will be given either tapentadol~     or morphine prolonged-release tablets. Assignment will be done randomly (like tossing a~     coin). The participant and the caregiver will know which medication they are taking. The~     primary endpoint is based on data collected in Part 1 of this trial.~      If eligible and willing, participants from Part 1 can enter a 12 month follow-up period (Part~     2). In Part 2 of this trial participants will be treated with tapentadol prolonged release~     tablets or with the standard of care (observation arm).~   "
108163|NCT02151669|"~     Epidemiologic studies suggest that some nutrients can be affected lung function. Moreover, no~     previous studies have prospectively evaluated the effect of the Mediterranean dietary pattern~     in lung function in smokers. Phase II of the RESET study , a clinical trial to evaluate the~     efficacy of a motivational smoking intervention based on information obtained by spirometry~     (FIS project PI11/01962).~   "
108164|NCT02151656|"~     The purpose of this study is to evaluate the potential efficacy of oral F17464 in comparison~     to placebo over 6 weeks in patients with acute exacerbation of schizophrenia. Study design:~     double-blind, randomized, placebo-controlled, parallel-groups, fixed-dose design, multicentre~     study.~   "
108165|NCT02151643|"~     The main purpose of this study is to see whether PT20 can help people with a high level of~     phosphate in their blood (called Hyperphosphatemia) that are being treated with dialysis for~     kidney disease.~   "
108166|NCT02151630|"~     Plantar warts can be bothersome and painful requiring treatment. The investigators will~     compare the efficacy of pyruvic acid and salicylic acid in treating multiple plantar warts.~     Patients with multiple plantar warts will be randomized to receive either pyruvic acid 70% or~     compound salicylic acid solution (salicylic acid 16.7%, lactic acid 16.7%, and collodion~     100%) applying topically twice a day for 4 weeks. Patients will be visited every 2 weeks for~     one month after starting treatment and then every one month for up to 3 months. The number~     and size of warts will be evaluated.~   "
108167|NCT02151617|"~     The purpose of this study in healthy people is to evaluate safety, toleration and time course~     of plasma concentration of multiple oral doses of PF-06743649. The pharmacodynamic activity~     of PF-06743649 will also be assessed. The effect of food on PK of PF-06743649 will also be~     investigated.~   "
108201|NCT02151162|"~     The study is to explore the effectiveness of omega-3 fatty acids and mindfulness-based stress~     management program to maintain healthy mental state in hospital nurses. The participants will~     be junior nurses who work in inpatient wards and are not clinically depressed. The~     participants will be randomly allocated to four intervention arms: 1) Mindfulness-based~     stress management program plus omega-3 fatty acids pills ; 2) Mindfulness-based stress~     management program plus placebo pills; 3) Psychoeducation leaflet plus omega-3 fatty acids~     pills; and 4) Psychoeducation leaflet plus placebo pills. Thirty participants will be~     allocated to each arm. These interventions will terminate until three months from~     registration for each participant.~      Information about depression and anxiety symptoms (primary outcome), insomnia, burnout,~     presenteeism, quality of life, sick leave, consultation about mental state of herself, and~     oxidative stress will be collected at 3 months, 6 months (primary time point) and 12 months~     from registration for each participant.~   "
108168|NCT02151604|"~     Lung cancer is the second most commonly diagnosed cancer in the United Kingdom, accounting~     for 22% of cancer deaths. The main treatments for lung cancer are surgery, radiotherapy or~     chemoradiotherapy. Current methods, for assessing lung function in lung cancer patients i.e.~     spirometry and gas transfer are inadequate. We aim to develop a new technique capable of~     describing regional lung abnormality using hyperpolarized xenon gas MRI.~      The study will involve 50 patients diagnosed with lung cancer considered suitable for radical~     radiotherapy or chemoradiotherapy. Participants will be offered hyperpolarized Xe129 MR at~     baseline, two weeks after commencement of radiotherapy schedules and four followup visits~     over one year posttreatment.~      Patients will undertake extensive study measures at baseline and followup visits, including~     chest CT scans, ventilation/perfusion nuclear medicine scans, gadolinium enhanced MRI scans,~     pulmonary function tests, breathlessness scores, radiotherapy induced lung toxicity~     assessments and exercise testing. Participation in these full tests takes a day, allowing~     patients time to rest between tests and allowing for a period of observation following the~     final hyperpolarized xenon scan.~      The investigators will correlate baseline hyperpolarized Xe129 MR imaging with spirometry and~     breathlessness scores to determine if tolerance for radiotherapy is better predicted by~     hyperpolarized Xe129 MR imaging. The investigators will evaluate changes in hyperpolarized~     Xe129 MR imaging before and after radiotherapy (RT) to determine if it provides better~     monitoring of response compared with spirometry.~      The study will take place at the Churchill Hospital, Oxford University Hospitals National~     Health Service Trust and will be funded by the National Institute for Health Research Oxford~     Biomedical Research Centre. Hyperpolarized Xe129 MR imaging has the potential to inform~     individual suitability for radiotherapy schedules better than the investigations used~     currently. In addition, hyperpolarized Xe129 MR imaging has the potential for better~     monitoring of treatment response and improved detection of radiation induced lung injury,~     invaluable to treating patients with radiation induced injury.~   "
108169|NCT02151591|"~     The purpose of this study is to develop and test an integrated cognitive-behavioral~     intervention for smoking and alcohol among heavy drinking smokers. The current pre-pilot~     phase will be used to refine this protocol for the subsequent randomized, controlled pilot~     phase. The current study phase has two parts: 1) an intake session and brief physical; 2) a~     12-week treatment phase in which participants receive varenicline (Chantix) and weekly,~     personalized counseling.~   "
108170|NCT02151578|"~     A well-implemented community-based program of early and appropriate treatment of~     fevers/malaria episodes and pneumonia,will improve child survival as measured by a reduction~     of the less than five mortality rate.~   "
108171|NCT02151565|"~     Sciatica is a common pain problem that affects not only the patient but also constitutes a~     socioeconomic burden and thus affects the whole society. So far, current pharmacologic~     therapies are inadequate for many patients. Therefore, we evaluated application of high-tone~     external muscle stimulation (HTEMS) compared to transcutaneous electrical nerve stimulation~     (TENS) on radicular pain associated with sciatica.~   "
108172|NCT02151552|"~     The purpose of this study is to learn more about the basic responses of the lungs to~     inflammation using positron emission tomography, or PET, imaging scans of the lungs. PET is a~     machine that detects radiation and generates pictures using a donut-shaped scanner similar in~     appearance to an x-ray CAT or computed tomography (CT) scan or an MRI. Inflammation is the~     way our bodies react to irritation or injury, and involves red, warm, and often painful~     swelling of the affected tissue. An enzyme called inducible nitric oxide synthase (iNOS)~     contributes to the development of lung inflammation.~   "
108173|NCT02151539|"~     This research trial studies medical chart review in determining outcomes of second-line~     therapy in patients with acute graft-versus-host disease previously treated with~     extracorporeal photopheresis or other systemic therapies. Gathering information about~     second-line therapy in patients with acute graft-versus-host disease may help doctors learn~     more about the disease and find better treatment.~   "
108174|NCT02151526|"~     This is a Phase 1/2, open label, safety, and efficacy study of the administration of~     LentiGlobin BB305 Drug Product to subjects with either beta-thalassemia major or severe~     sickle cell disease (SCD).~   "
108175|NCT02151513|"~     The purpose of this study is to examine the changes in immune function, as measured by~     biomarkers in the blood, that happen with intrathecal (spinal) delivery of opioid medications~     for the treatment of moderate to severe cancer pain.~      Hypothesis: Treatment of pain with intrathecal (spinal) therapy is associated with little~     alteration of immune function as measured by biomarkers in the blood of cancer patients with~     moderate to severe pain.~   "
108176|NCT02151500|"~     The goal of this study is to test the feasibility and acceptability of providing an~     experiential assessment interview that targets emotional and stressful experiences in primary~     care. In this randomized, controlled trial, the investigators will compare an interview~     condition to a wait-list control condition. The investigators hypothesize that helping~     individuals first identify the links between their stress and symptoms will likely increase~     their awareness and endorsement of the link between stress and physical symptoms, including a~     willingness to engage in stress management techniques. It is also expected that helping raise~     an individual's awareness about their symptoms, followed by an experience and expression of~     unexpressed emotions is likely to influence their physical symptoms and psychological status.~   "
108177|NCT02151487|"~     The aim of this randomized, observer-blinded clinical trial is to evaluate the anesthetic and~     analgesic efficacy of adding dexamethasone and clonidine to ropivacaine in supraclavicular~     nerve block. The investigators hypothesized that addition of dexamethasone and clonidine to~     ropivacaine would prolong the duration of analgesia in supraclavicular nerve block compared~     with ropivacaine alone.~   "
108178|NCT02151474|"~     The purpose of this study is to explore the safety, tolerability and efficacy of INCB047986,~     in subjects with moderate to severe rheumatoid arthritis.~   "
108179|NCT02151461|"~     The goal of this study is to demonstrate that leucine in combination with a low does of~     metformin can serve as an adjunct to diet and exercise to improve blood glucose levels in~     type 2 diabetic subjects. This study will compare three doses of a leucine-metformin~     combination to the standard metformin dose in controlling blood glucose levels in type 2~     diabetic patients.~   "
108202|NCT02151149|"~     Study comparing two regimens of nab-paclitaxel and carboplatin combination in elderly subject~     (≥ 70 years old) with advanced NSCLC~   "
108203|NCT02151136|"~     The purpose of this study is to determine whether sugar water (TootSweet, 24% sucrose)~     effectively reduces pain in children ages 12 to 36 months undergoing venipuncture, as~     measured by pain scores and cry duration~   "
108204|NCT02151123|"~     The specific aim of the study is to determine the false negative rate of the Metabiomics~     Colon Polyp and Colorectal Cancer Assay for Cancer.~   "
108205|NCT02151110|"~     Phase 1 single IV dose study to evaluate safety and tolerability of MEDI4920~   "
108345|NCT02149277|"~     The purpose of the study is to see the impact of intrauterine injection of recombinant GCSF~     on pregnancy and implantation rate during IVF-ICSI (intracytoplasmic sperm injection)~     protocols as well as in frozen embryo transfer. In addition, following the injection, the~     level of G-CSF in the bloodstream will be verified.~   "
108180|NCT02151448|"~     This trial is to determine the safest dose of a triple combination (chemokine modulatory~     regimen or CKM) of celecoxib, interferon alfa (IFN), and rintatolimod that can be given with~     a DC vaccine as treatment of peritoneal surface malignancies after standard of care surgery.~      The first phase of this study will determine the safest dose of IFN that can be given in~     combination with celecoxib and rintatolimod along with a DC vaccine. The doses of celecoxib~     (400 mg) and rintatolimod (200 mg) will be consistent while the dose of IFN will be increased~     (5, 10, or 20 MU/m2) as participants are enrolled to the trial. The high dose of IFN in~     combination with celecoxib and rintatolimod will be used for the next phase of the clinical~     trial. After surgery, participants will receive 2 cycles of the investigational treatment.~      The second phase of this study will test if the investigational treatment has any effects on~     peritoneal surface malignancies. The doses of the combination determined in the first phase~     will be used in this phase of the clinical trial. After surgery, participants will receive 2~     cycles of the investigational treatment, followed by standard chemotherapy as determined by~     their oncologist, and then 2 more cycles of the investigational treatment.~   "
108181|NCT02151435|"~     Idiopathic pulmonary fibrosis (IPF) is a progressive, fatal, fibrotic disorder of the lung.~     The estimated prevalence is 30-80/100,000 in the United States with incidence estimates~     clearly rising. A major challenge in the care of patients with IPF is determining prognosis.~     The natural history of IPF is usually one of inexorable decline in lung function, ultimately~     resulting in death from respiratory failure. However, longitudinal physiologic decline in IPF~     is heterogeneous and difficult to predict in individual patients. While some patients with~     IPF may remain stable for years, in others the disease may progress rapidly over a relatively~     short time. We hypothesize that peripheral blood biomarkers based on extracellular matrix and~     matrix-modifying molecules will improve prognostication in patients with IPF.~   "
108182|NCT02151422|"~     Despite the advances in pharmacological therapy for asthma, there has been an increasing~     worldwide interest in alternative therapies for asthma. Treatments and therapies such as~     yoga, acupuncture, homeopathy, hypnosis and Buteyko and other breathing techniques have been~     used as complementary therapies however little evidence exists behind such practices.~      Data from systemic reviews and randomized control trials provide evidence of benefit although~     additional confirmation is still needed. Among the most common techniques are the Buteyko~     breathing exercises that aim to reduce minute ventilation by instruct asthmatics patients to~     breathe shallowly and slowly through the nose. The second common technique is the Pranayama,~     or yoga breathing exercises which emphasizes deep respirations and exhalation prolongation.~      Our goal is to assess the effectiveness of breathing exercises as a complementary therapy for~     asthma.~   "
108183|NCT02151409|"~     This trial is conducted in Europe. The aim of this trial is to develop a complement system~     targeted monoclonal antibody (mAb) to be used in treatment of subjects with chronic~     autoimmune diseases.~   "
108184|NCT02151396|"~     There is evidence both that computer-administered cognitive training can improve ADHD working~     memory deficits and that this type of training in non-ADHD enhances normal working memory~     ability by altering brain activity in prefrontal cortex and the parietal lobe. However, no~     study has characterized brain activity changes following working memory training in ADHD to~     understand what neural changes occur when cognitive deficits are remedied. This R21~     exploratory study will examine the neural basis of cognitive training treatment gains in~     working memory, ADHD symptoms, and various other executive abilities. We will test the~     hypothesis that working memory training increases frontoparietal brain activation and examine~     other regions to see if there is any evidence for neural compensation (i.e., engagement of~     brain regions after training that are not normally recruited for task performance).~   "
108185|NCT02151383|"~     The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of an~     intravenous infusion of serelaxin on top of standard of care therapy, in pediatric patients~     with acute heart failure (AHF)~   "
108186|NCT02151370|"~     This observational study will collect data about safety in female patients with advanced~     ovarian epithelial cancer with measurable residual disease after surger y. The treating~     physician has decided to treat the patients with Avastin (bevaci zumab) in combination with~     chemotherapy followed by Avastin monotherapy accordin g to the local label. Data will be~     collected for 72 weeks.~   "
108187|NCT02151357|"~     -  Investigate the safety and tolerability of multiple DCBCI0901 infusions in patients with~          advanced solid tumor~        -  Pharmacokinetic parameters will be calculated for DCBCI0901, if data permit.~        -  Anti tumor activity: The efficacy endpoint will be the overall response rate (ORR)~          defined as the proportion of patients who continuously receive treatment after Cycle 1~          with a best overall response of complete response (CR) or partial response (PR).~   "
108188|NCT02151344|"~     H7N9 viruses have caused a recent outbreak of severe illness in humans in China. The purpose~     of this study is to evaluate the safety and immune response of an H7N9 A/Anhui/13 ca~     influenza virus vaccine followed by an inactivated subvirion H7N9 vaccine at varying~     intervals.~   "
108189|NCT02151331|"~     The overarching goal of this study is to build the most cost-effective adaptive~     implementation intervention involving a site-level implementation intervention strategy:~     Replicating Effective Programs (REP), and the augmentation of REP using either External~     Facilitation or a combination of an External and Internal Facilitation to improve patient~     outcomes and the uptake of an evidence-based program for mood disorders (Life Goals-LG) in~     community settings.~   "
108190|NCT02151318|"~     In this study, the investigators will collect tissue from patients undergoing trabeculectomy~     for primary open-angle glaucoma treatment. This tissue would normally be discarded. These~     trabecular meshwork (TM) cells can be cultured and used experimentally to better understand~     the mechanisms of glaucoma. These TM biopsies will be cultured on the same day as the~     trabeculectomy using established techniques.~   "
108191|NCT02151305|"~     We investigated the hemostatic differences according to the main anesthetic agents by~     analyzing rotational thromboelastometry (ROTEM) under the hypothesis that propofol-based~     anesthesia would impair postoperative coagulability more than the sevoflurane-based~     anesthesia.~   "
108346|NCT02149264|"~     This is a phase 3, open-label, non-randomized, clinical trial to evaluate the efficacy and~     safety of FE 999303 (Testosterone gel) in adult hypogonadal males.~   "
108192|NCT02151279|"~     Chitosan, the main component of the exoskeletons of crustaceans, mollusks and cephalopods,~     has been used as a fining agent in wines. However, its safety among patients allergic to~     shellfish has never been evaluated.~      Adult patients followed at the Allergy and Clinical Immunology Department who have been~     diagnosed with anaphylaxis to shrimp will be invited to participate in the study.~      Clinical data will be collected to ascertain for eligibility and written information will be~     provided. After signing informed consent, included subjects will perform skin prick-to-prick~     tests (PTP) with shrimp boiling water condensate and with fined and unfined wines. All will~     perform double blind oral challenge with the fined and unfined wines during 1visit day; the~     placebo (unfined wine) and active challenge (fined wine with chitosan) will be separated by 2~     hours. Challenge protocol will be performed with successive increasing doses administered in~     4 steps at 15-minute intervals for a total of 100 mL. During the challenge signs and symptoms~     will be monitored by a trained physician.~      Results will be presented as negative or positive (defined by presence of symptoms and signs~     of an allergic reaction).~      Categorical data will be compared by chi-square test. P<0.05 will be considered statistically~     significant.~   "
108193|NCT02151266|"~     Cognitive impairment (CI) is a prevalent problem in persons with HF heart failure (HF) and is~     associated with adverse clinical outcomes, higher mortality and poorer quality of life.~     Studies designed to attenuate or alleviate CI in persons with HF are limited, and evidenced~     based guidelines for screening and provision of care are practically nonexistent. Improvement~     in cognition has been reported following some therapies in HF and is thought to be the~     consequence of enhanced cerebral perfusion and oxygenation, suggesting that CI may be~     amenable to intervention in this population. Exercise is documented to increase cerebral~     perfusion and oxygenation by promoting neuroplasticity and neurogenesis, and, in turn,~     cognitive functioning. Brain derived neurotrophic factor (BDNF) is a key mechanism underlying~     the effect of exercise, but most studies of BDNF have not included individuals with CI or~     chronic illness populations, and its relationship to cognitive outcomes in HF is unknown.~     Cognitive retraining techniques, originally developed to treat traumatic brain injury, have~     also shown efficacy in broader neurologically-affected conditions and may provide added~     benefit to that of exercise. Animal studies suggest exercise and plasticity-based cognitive~     training could act synergistically through different neural mechanisms to have a more~     pronounced and positive impact on cognitive outcomes than either approach alone; but this has~     not been previously tested as an intervention to improve CI. The proposed feasibility study~     is designed to test the acceptability and limited efficacy of a combined exercise (Ex) and~     cognitive training (CT) program to improve CI in stable NYHA class II and III HF patients~     compared to either exercise alone or a no-intervention, attention-control group. Findings~     will be used to support the development of a future, large scale study to test the efficacy~     of this intervention to improve cognitive functioning, quality of life, and physiological~     markers of improved brain function in HF. In addition, we have an optional sub-study that~     participants may participate in order to further our understanding of biomarkers of~     inflammation and gen e expression before and after exercise.~   "
108194|NCT02151253|"~     The objective of the study is to evaluate armodafinil as a wakefulness-promoting therapy as a~     means of improving residual daytime sleepiness in patients with treated nocturia.~   "
108195|NCT02151240|"~     The purpose of this study is to evaluate the efficacy and safety of Foscarnet Sodium and~     Sodium Chloride Injection in patients with herpes zoster, and observe incidence of~     Postherpetic neuralgia~   "
108196|NCT02151227|"~     Magnesium is an essential mineral found in many foods; rich sources include whole grains,~     green leafy vegetables, coffee, and legumes. Magnesium is a critical cofactor in >300~     enzymatic reactions, including those related to energy metabolism. Reduced magnesium intake~     and serum concentrations have been detected, both cross-sectionally and prospectively,in type~     2 diabetes and insulin resistance, hypertension, dyslipidemia, and cardiovascular diseases.~      Different studies have reported inadequate magnesium intake and low serum magnesium~     concentrations may correlated also with metabolic syndrome, defined as a cluster of metabolic~     disorders including obesity, hypertension, dyslipidemia and impaired glucose tolerance or~     diabetes mellitus. Previous studies on this subject, however, reported contradicting results.~     Some investigations reported inadequate magnesium intake and low serum magnesium~     concentrations while others did not.~      To our knowledge, the epidemiological evidence on the relation between dietary magnesium~     intake and risk of metabolic syndrome has not yet been summarized.Therefore, the~     investigators will perform a systematic review and dose-response meta-analysis to assess the~     association between dietary and circulating magnesium level and risk of metabolic syndrome.~   "
108197|NCT02151214|"~     In malnourished patients in the palliative phase of cancer, the question is raised of the~     relevance of implementing artificial nutritional assistance instead of oral feeding when this~     is possible.~      Medical prescription and implementation of artificial nutrition at this stage of the illness~     seem less governed by data acquired by science than by subjective reasons (related to~     beliefs, to a cultural or religious tradition, to the symbolic role of eating, to the deeply~     ingrained fear of dying of hunger, to a portrayal of care, etc.) while interacting with~     teams, the patient and his family and relatives.~      And yet, the benefits/risk balance and the effect on quality of life of parenteral nutrition~     in a palliative situation for patients presenting with a normal alimentary tract is poorly~     understood. The discomfort and risks of central venous or nasogastric artificial nutrition~     require that the benefits of artificial nutrition be proven. The nature of these benefits~     relate first and foremost to the quality of life experienced by the patient in such a~     context. Only a controlled randomized study may lead to an optimal palliative nutritional~     management of undernutrition to be determined, and to inform the patient and his/her~     relatives clearly in order for them to express their preferences.~      We hypothesize that abstaining from artificial parenteral central venous nutrition and~     associated hydration for nutritional purposes improves quality of life without significant~     loss of survival compared to implementing artificial nutrition, when considered, in the~     absence of any specific curative treatment in anorexic patients in the palliative phase of~     cancer.~      To test this hypothesis, we propose to carry out a multicenter, prospective, controlled,~     randomized study in order to evaluate the efficacy of implementing parenteral nutrition~     compared to abstaining from doing so on the quality of life of undernourished patients in the~     palliative phase of cancer. The effect on overall survival and the nutritional parameters~     will be evaluated.~      The ALIM K trial will be carried out in 12 centres specializing in supportive and~     onco-hematology care .~   "
108198|NCT02151201|"~     We evaluated the impact of viewing an educational video about influenza vaccination in~     pregnancy just prior to a routine prenatal visit on vaccination health beliefs and~     vaccination rate. We hypothesized that the video would positively impact both vaccination~     health beliefs and vaccination rate compared to a control video.~   "
108199|NCT02151188|"~     This study hypothesizes that milk protein consumed together or shortly before a white rice or~     white bread carbohydrate meal exerts different influence on the glycaemic, insulinaemic~     responses.~   "
108200|NCT02151175|"~     We intend to use focused ultrasound to stimulate or suppress brain activity in patients with~     epilepsy. We hypothesize that focused ultrasound is capable of brain stimulation or~     suppression visible with functional MRI, and will not cause tissue damage.~   "
108217|NCT02150954|"~     The purpose of this research study is to compare induction of labor using a foley catheter~     bulb with a low dose of oxytocin versus a foley catheter bulb with an increasing dose of~     oxytocin. A foley catheter bulb with or without oxytocin is a common method of labor~     induction in patients whose cervix is not significantly dilated or thinned out (effaced).~     Oxytocin (pitocin) is a medicine used to increase the number and strength of the womb's~     contractions.~   "
108206|NCT02151097|"~     This study will evaluate the feasibility of using intra-operative Cerenkov Luminescence~     Imaging (CLI) of prostatectomy specimens to determine tumour margin status. The samples will~     be imaged using the LightPathTM Imaging System which consists of a light-tight box containing~     an ultra-sensitive lens and radiation-shielded camera. This study will measure the~     correlation between margin status of the WLE specimen and the metastatic status of dissected~     lymph nodes as determined by the LightPathTM Imaging System and by histopathology. This is a~     pilot study to assess feasibility before proceeding to a pivotal study to evaluate the~     benefits of the LightPathTM system in clinical practice.~   "
108207|NCT02151084|"~     This is a phase II study (the second stage of testing a new drug or new drug combinations) to~     see how useful two different schedules of study drug selumetinib with cisplatin and~     gemcitabine are compared to cisplatin and gemticabine alone in patients with biliary cancer.~      Selumetinib, an oral drug which plays an important role in the regulation of cell growth (MEK~     1/2 inhibitor) has been shown to shrink tumours in patients with biliary cancer and other~     types of human cancers. Selumetinib has also been shown to shrink tumours when given in~     combination with cisplatin and gemcitabine in research studies done in animals and in some~     patients with biliary tract cancer. Cisplatin and gemcitabine are intravenous drugs that work~     by damaging DNA in tumor cells so that they are unable to grow and divide.~   "
108208|NCT02151071|"~     This study will correlate the resection margin status of the breast cancer tumour (WLE~     specimen), cavity shavings (if any) and breast cavity, and the metastatic status of axillary~     lymph nodes as determined by EnLight, LightPath, and histopathology. This is a pilot study to~     assess feasibility before proceeding to a pivotal study to evaluate the use of these imaging~     systems in clinical practice.~   "
108209|NCT02151058|"~     The whitening action of an investigative hydrogen peroxide/sodium fluoride containing mouth~     rinse will be evaluated through stain removal using mean Lobene Stain Index over 14 days~     compared to a currently marketed hydrogen peroxide containing whitening mouth rinse (Crest®~     3D White Multi-Care Whitening Rinse, Glamorous White, Fresh Mint). A currently marketed~     toothpaste (Colgate® Cavity Protection) will be included as the negative control in order to~     compare to brushing alone.~      225 healthy volunteers will be enrolled in this two week study. Volunteers who qualify to be~     in this study will have an equal chance of being assigned to one of the three treatment~     groups. Volunteers will have a total of 5 clinic visits including 1) screening, 2) baseline~     3) Day 4 (after 3 days of use), Day 8 (after 7 days of use) and Day 15 (after 14 days of~     use). Volunteers will maintain a diary at home to record each treatment use. Examinations for~     oral hard/soft tissue assessment and extrinsic tooth stain after the subject brushes with~     water and floss will be completed at Baseline and repeated at Clinic Visits 3, 4, and 5,~     which are on Days 4, 8 and 15 post baseline (i.e., after 3, 7, and 14 days of product use).~   "
108210|NCT02151045|"~     In discal sciatica, after failure of medical treatment, the investigators propose frequently~     a spinal infiltration of corticoids the most closer of disco-radicular conflict. Recently,~     some cases of paraplegia during lumbar foraminal infiltrations have induce a reduction of~     indications of this type of infiltration. An alternative would be to propose a lateral~     epidural infiltration on contact with conflict.The objective of this study is to compare, in~     112 patients with a less than 6 months discal sciatica, the efficacy on pain of a non target~     posterior epidural space infiltration of corticoids done at L3-L4 stage on scan control~     versus an epidural infiltration of the same corticoid done in lateral on contact of disco~     radicular conflict on scan control.~   "
108211|NCT02151032|"~     The goal of this research study is to compare how people who are 45-75 years old respond to 3~     different versions of a program about screening tests for colorectal cancer. Researchers want~     to use this study as part of a long-term project to learn the best ways to communicate health~     information to patients.~   "
108212|NCT02151019|"~     The study aims to compare the incidence of acute grade 2 GI toxicity in the Control 3-D~     Conformal Radiotherapy compared to the Intensity Modulated Radiotherapy (IMRT) arm for~     locally advanced rectal cancer.~   "
108213|NCT02151006|"~     140 women with expected poor ovarian response undergoing IVF/ICSI will be randomly divided~     into 2 groups using computer generated random numbers . Group 1 ( study group) will receive~     DHEA 25 mg ( DHEA 25mg, Natrol , USA) t.d.s daily for 12 weeks before starting IVF/ICSI~     cycle. Group 2 ( control group) will not receive DHEA. Patients included in the study will be~     subjected to full history taking and clinical examination. On the second day of menstruation~     serum FSH, LH, Prolactin and Oestradiol will be assessed and the antral follicular count~     (AFC) will be assessed using a vaginal ultrasound scan. AFC will be defined as the number of~     follicles measuring 3-10mm.~      All patients will have gonadotropin antagonist protocol with Human menopausal gonadotrophin~     (HMG) stimulation until the day of (Human chorionic gonadotrophin (HCG) administration. On~     the day of HCG administration, ovarian ultrasound scan will be performed using a transvaginal~     probe. Oocytes will be aspirated 34-36 hours after HCG administration. Oocytes will be~     fertilized and embryos will be transferred. Both groups will be compared regarding the~     proportion of pregnancy.~   "
108214|NCT02150993|"~     FIT-2 is a multi-country, phase IIb, randomized, non-comparative study, carried out in West~     Africa (Côte d'Ivoire, Burkina Faso, Senegal, Togo).~      ARV-naïve HIV-2 infected adult patients will be recruited and followed during 96 weeks.~      The objective is to evaluate the efficacy and safety of 3 first-line treatments in HIV-2~     infected adult patients, in West Africa. A treatment will be considered as effective if more~     than 55% of patients in that arm attain global success at 96 weeks.~   "
108215|NCT02150980|"~     Background: Worldwide, injuries from trauma represent a major public health problem. The~     World Health Organization (WHO) has deemed this problem as one of the most important global~     priorities, calling 2011-2020 the 'Decade of Action for Road Safety'. Despite this, there is~     little empirical data in low and middle-income countries quantifying the burden of~     musculoskeletal injuries.~      Methods: INORMUS is a global, prospective, multi-center, observational cohort study. The~     primary objective of the study is to determine the mortality, re-operation and infection~     rates of musculoskeletal trauma patients within 30 days post-hospital admission. The INORMUS~     study seeks to enroll 40,000 patients from low-middle income countries in Africa, Asia, and~     Latin America.~   "
108216|NCT02150967|"~     This is a multi-center, open label, single arm phase II study evaluating BGJ398 anti-tumor~     activity in advanced or metastatic cholangiocarcinoma patients with FGFR genetic alterations.~   "
108218|NCT02150941|"~     Upper endoscopy is performed for upper gastrointestinal bleeding (bleeding in the esophagus,~     stomach, or part of the duodenum) to identify and potentially treat the cause of bleeding.~     However, blood clots often make visualization difficult during endoscopy. The current~     practice is to try to wash off and suction up these blood clots with the endoscope. However,~     this is often not successful due to blood clots blocking the suction channel.~      A new device has been approved by Health Canada that attaches to the endoscope and helps~     prevent blockage. It is believed that this device will help doctors suck out blood clots and~     potentially improve visualization, identification of the cause of bleeding, and possibly~     health outcomes, although this has never been proven. The purpose of the this clinical trial~     is to test whether the device works and whether it can help patients with this type of~     bleeding.~   "
108219|NCT02150928|"~     The purpose of this study is to evaluate the serum asparaginase activity in subjects ages 18~     to <40 years with ALL or LBL who have developed a hypersensitivity to native E. coli~     asparaginase or pegaspargase.~   "
108220|NCT02150915|"~     The purpose of this study is to test whether the application of acupuncture alters the~     mechanical (range of elbow extension motion) and physiological (eg, intensity and onset of~     discomfort, tingling feeling and/or feeling of tension or restriction of movement) responses~     of the neurodynamic test of nerve median in asymptomatic individuals~   "
108221|NCT02150902|"~     Atrial fibrillation (AF) is an abnormal heart rhythm in which the top chambers of the heart~     beat very fast. AF catheter ablation is a known technique to convert heart rhythm from AF to~     normal rhythm. The technique sends out electrical energy through a catheter (long thin round~     solid tubes) to destroy the heart tissues in a focused area where AF is starting. This~     technique is practiced at many hospitals, including the Heart Institute, and is not~     experimental.~      The AWARE study will compare two techniques of AF catheter ablation:~        1. Ablation of tissues in wide circular bands around the opening of the pulmonary veins~          (bring blood back from lungs) in the left upper chamber of the heart. A medicine called~          adenosine will be given to unmask any incompletely ablated area. Additional ablations~          will be given if required. This is standard procedure.~        2. Same as above but adenosine will not be used. Instead, additional ablation of a second~          circular band of tissues around the opening of the pulmonary veins will be given. This~          additional ablation is not standard procedure and is considered experimental.~      The Investigators are testing if adding more ablation sites will help maintain normal heart~     rhythm and reduce the rate of return to AF. The study will compare the occurrence of medical~     events and complications between the two groups.~      Identical supplies and equipment used in both techniques have been approved by Health Canada.~     Adenosine is currently approved by Health Canada for the treatment and diagnosis of~     arrhythmias.~      396 participants from study sites across Canada will be randomly assigned similar to~     flipping a coin to treatment group 1 or group 2.~      After the ablation, participants will have study follow-up at 3, 6 and 12 months. All~     participant's will be followed for a minimum of 12 months.~   "
108222|NCT02150889|"~     The investigators are interested in how skeletal muscle processes fat and how this may affect~     insulin resistance. This is an important question since insulin resistance predates and~     predicts type 2 diabetes. The investigators are especially interested in learning about the~     effects of weight and training on insulin resistance. The investigators will study people~     before and after supervised aerobic or yoga training to identify differences in resting fat~     and sugar metabolism which may lead to differences in insulin resistance. The investigators~     will test these differences using stable isotopes, and the use of these stable isotopes is~     experimental.~      Overweight/Obese Group: Eight visits will be required at the University of Minnesota Clinical~     Research Unit. Four visits will be done before training (screen and 3 pre-training visits), 1~     visit during the training, and 3 post-training visits will be done. In between, the training~     will take about 16 weeks and will be a supervised treadmill program.~      Lean/Trained Group: Four visits will be required at the University of Minnesota Clinical~     Research Unit (screen and 3 study visits).~   "
108223|NCT02150876|"~     Bioresorbable polymer drug eluting stents (DES) are an indisputable improvement over~     first-generation DES with promising results on long-term adverse events. But the thicker~     polymer and/or strut may hinder its deliverability. Complex procedures challenge stent~     deliverability and stent delivery failure impacts clinical prognosis.~      This registry aimed to assess the immediate performance of the third-generation Synergy~     everolimus-eluting stent (sEES) and its 12-month clinical follow-up in an all-comer~     population.~   "
108224|NCT02150863|"~     This project aims to treat field cancerization ( pre-skin cancers) in a manner that will~     reduce the future pre-skin cancers and non-melanoma skin cancers in patients with significant~     photodamage.~      This is 3 year prospective, randomized, controlled comparison of a single treatment with~     carbon dioxide laser resurfacing vs. carbon dioxide resurfacing plus autologous epidermal~     skin graft from a non sun exposed site vs. control.~      Thirty subjects will receive treatment with each of the modalities.~      The primary measures of efficacy are (a) count of the number of actinic keratosis and non~     melanoma skin cancers, (b) blinded evaluation of severity from standard digital photographs~     taken before and after the treatments, and (c) change in histology before and after~     treatment. Safety measures include (a) pain, (b) scarring, (c) wound healing, (d) and~     infection~   "
108225|NCT02150850|"~     Bisphosphonates are recommended as first-line agents to reduce fracture risk in patients with~     osteoporosis and have in general an excellent safety profile. However, recent reports have~     noted that prolonged use of bisphosphonates may be associated with rare but serious adverse~     effects, namely atypical femur fractures (AFF), an atraumatic subset of subtrochanteric and~     diaphyseal fractures.~      The overarching aim of this project is to contribute to the characterization of clinical,~     biomechanical, radiological and genetic predictors of AFF, associated or not with~     bisphosphonate and-or denosumab therapy. AFF arise on the lateral (external) aspect of the~     subtrochanteric and diaphyseal regions of the femur, regions subjected to high mechanical~     loads. Because of this unique distribution, the investigators hypothesis is that patients~     with AFF demonstrate specific geometrical variations of their femur whereby baseline tensile~     forces applied to the lateral cortex are higher and might favour the appearance of these rare~     stress fractures. Measurements to investigate these geometric variations with be calculated~     from 3D images reconstructed using scans procured using the EOS® low irradiation 2D-3D X-Ray~     scanner.~   "
108226|NCT02150837|"~     The purpose of this study is to retrospectively and systematically review records of~     overweight and obese Medifast Weight Control Center (MWCC) members who have been assigned to~     the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan for weight loss to gain a better understanding of~     the effectiveness of these programs. The study will describe demographics of this population,~     along with weight loss, anthropometrics, body composition and effects on available~     cardiovascular parameters. Adherence to the plans will also be examined.~      The study hypothesis is that the 5 & 2 & 2 Meal Replacement Plan and the 4 & 2 & 1 Meal~     Replacement Plan are both effective programs for weight loss in overweight and obese adults.~   "
108229|NCT02150798|"~     The aim of the present study was to evaluate the effects of a high fat, low carbohydrate~     (CHO) diet on clinical status during 60 days of follow-up in patients with stable heart~     failure (HF).~      In a randomized controlled clinical trial 44 ambulatory patients with HF were included,~     assigned to an intervention (40% CHO, 40% fat and 20% protein; n=22) or control groups (50%~     CHO, 30% fat, 20% protein; n=20). Both groups received recommended pharmacological~     management. At baseline and at 2 months of follow-up, the variables evaluated were: body~     composition, handgrip strength, oxygen saturation, dietary intake, clinical data, lipid~     profile, plasma glucose and exercise tolerance~   "
108230|NCT02150785|"~     Currently, thrombolysis is offered to less than 1% of patients in low to middle income~     countries (LMICs) where access to health care is often based on the financial capabilities of~     the patient. There is therefore an urgent need for an effective but affordable alternative~     thrombolytic agent. Streptokinase (SK) ($35) is much more economically feasible as opposed to~     tissue plasminogen activator (tPA) ($2800). In this study, we propose a reevaluation of the~     use of streptokinase (SK) in the treatment of acute ischemic stroke. We want to emphasize~     that we will only consider this as a 'treatment option' if we are absolutely certain that IV~     tissue plasminogen activator (tPA) will not be offered to the patient due to its high cost.~     It is hypothesized that treatment with SK in appropriately selected patients will be~     associated with a hemorrhagic transformation rate similar to that of tPA.~   "
108231|NCT02150772|"~     Background: The main goal when diagnosing thyroid nodules, is to differentiate the few~     malignant from the overwhelming background of benign nodules. Currently available~     pre-operative tests are unable to rule out malignancy in a subset of patients and diagnostic~     thyroid surgery is necessary. Therefore, there is a need to develope the diagnostic tools for~     pre-operative diagnostic work-up of thyroid nodules.~      The study will investigate a novel ultrasonographic technique called Shear Wave Elastography~     (SWE) in the pre-operative evaluation of thyroid nodules.~      Aim:~      To evaluate the diagnostic value of SWE in the pre-operative diagnosis of thyroid nodules in~     a tertiary surgical center.~      Perspectives:~      An optimization of the pre-operative risk-stratification and diagnosis of thyroid nodules can~     reduce unnecessary thyroid surgery, with a reduction in morbidity and better use of the~     economic and surgical resources.~   "
108232|NCT02150759|"~     -  Comparison study of analgesic effects for dexmedetomidine-fentanyl vs~          dexmedetomidine-ketamine~        -  lateral position for spinal anesthesia in femur proximal fracture patients~   "
108233|NCT02150746|"~     It is hypothesized that circulating tumor cells (CTCs) from pancreatic adenocarcinoma are~     released into the peritoneal cavity through blood lost during the surgical resection of these~     tumors resulting in peritoneal recurrence despite appropriate surgical resection. Targeting~     the mechanisms responsible for CTC adhesion to the peritoneum may result in inhibition of~     implantation and growth, thus preventing this mode of pancreatic cancer recurrence~     postoperatively.~   "
108234|NCT02150733|"~     This is a multi-center, open-label, Phase 1 study to evaluate the impact of hepatic~     impairment on the pharmacokinetics of Tivantinib in cancer subjects with varying degrees of~     hepatic function, from normal to severely impaired.~   "
108235|NCT02150720|"~     The main hypothesis of this clinical trial is that the use of intra-articular tranexamic acid~     and the fibrin glue plus usual hemostasis will reduce at least a 25% the postoperative blood~     loss with respect to usual hemostasis in patients undergoing subcapital femoral fractures.~   "
108236|NCT02150707|"~     This study aims to determine if different diabetes treatments have different effects on~     inflammation; in particular, kidney inflammation. This type of inflammation is common in~     people with diabetes, and can lead to kidney failure. This study will investigate the effect~     of different types of diabetes treatment on kidney inflammation. This will help us to decide~     if certain types of medicine should be preferred in people with evidence of inflammation in~     their kidneys, as this may help prevent major complications including kidney failure.~   "
108237|NCT02150694|"~     Apelins are substances which occur naturally in the body, and have an important role in heart~     disease. They have been shown to make blood vessels dilate, and improve the way the heart~     works.~      The investigators have devised 2 sets of experiments to investigate how the apelins affect~     blood vessels.~      In the first group of experiments,the investigators will give healthy volunteers up to 3~     different apelin substances, and use special research techniques to see how they affect the~     way that blood vessels work in the forearm.~      In the second group of experiments, the apelins will be given along with another form of~     apelin which blocks the effects of apelin in laboratory experiments. The investigators want~     to see if it blocks the effects of apelin in healthy humans.~      The investigators intend to test the hypothesis that:~      Apelin agonists are vasodilators in human resistance vessels, this effect will be blocked by~     an apelin receptor antagonist.~      This study will help us to understand more about how apelins work, and to suggest how they~     might be used to treat heart disease.~   "
108238|NCT02150681|"~     This study will investigate the effectiveness of mindfulness-based cognitive therapy (MBCT)~     for mood stabilization in perinatal women (preconception, pregnant, and postpartum) with a~     history of mood disorders. MBCT is a short-term group psychotherapy that has shown~     effectiveness in preventing depressive relapse. MBCT teaches mindfulness practices and~     cognitive-behavioral techniques.~   "
108239|NCT02150668|"~     Attention-Deficit/Hyperactivity Disorder (ADHD) is one of the most commonly diagnosed~     childhood disorders, with prevalence rates estimated at 8%. Several of the primary symptoms~     of ADHD relate to problems with temporal and materials organization (i.e. has difficulty~     organizing tasks and activities, loses things, is forgetful, and fails to finish~     school-work). In the school setting, problems with organization manifest as forgetting to~     complete or losing homework assignments, difficulties planning for the completion of~     long-term projects and studying for tests, and problems keeping class materials organized.~     These organizational difficulties become particularly problematic in middle school and are~     associated with low school grades and high parent and teacher ratings of academic impairment.~     In fact, organization of homework materials is one of the strongest predictors of academic~     performance in students with ADHD, above and beyond the impact of intelligence, school~     services, and ADHD medication use, and mediates the relationship between symptoms of ADHD and~     school grades.~      Given the relationship between temporal and materials organization and poor school~     performance, it is clear there is a need for interventions to address these difficulties. The~     PI sought to address this need by completing an IES Goal 2 study to develop a school-based~     intervention targeting organizational skills that was feasible for school mental health (SMH)~     providers to implement. The Homework, Organization and Planning Skills (HOPS) intervention~     was developed and refined based upon input from 20 school mental health (SMH) providers,~     students with ADHD and their families. SMH providers implemented the HOPS intervention, rated~     the intervention as highly user-friendly and feasible to implement, and demonstrated~     excellent fidelity to intervention procedures. Students who received the HOPS intervention~     made significant improvements in homework problems and organizational skills compared to a~     waitlist control. The feasibility and fidelity data demonstrate that the intervention has~     potential for widespread dissemination. Preliminary outcome data suggest that the~     intervention may significantly improve the academic performance of students with ADHD.~     However, the small sample size (N=23 HOPS & N=24 control) precludes firm conclusions about~     efficacy and moderators and mediators of intervention response. Accordingly, the primary goal~     of this Goal 3 study is to evaluate the efficacy of the HOPS intervention, which focuses~     teaching students' organization and time-management skills, as compared to an intervention~     targeting on-task behaviors during homework completion and efficiency of work completion, the~     Homework Support Intervention (HSI), and to assess moderators and mediators of intervention~     response.~      Middle school students with ADHD (N=260) will be randomly assigned to receive the HOPS~     intervention or the HSI intervention. Students in both groups will receive the same amount of~     intervention in terms of duration and frequency of intervention sessions. Six cohorts of~     students will be recruited for the project. Each cohort will consist of 22 students at each~     of two schools (44 per cohort) who will be randomly assigned to each of the two conditions.~     Objective measures of skills implementation, parent and teacher ratings of organization,~     homework problems, and academic impairment, and school grades will be examined pre and post~     intervention as well as at 8-week and 6-month follow-ups. Treatment fidelity and integrity~     will be closely monitored. Moderator and mediator analyses will be used to answer important~     questions about the types of students most likely to benefit from organizational skills~     intervention and the key mechanisms of change that lead to improved academic performance.~     This study has significant potential to improve the academic performance of students with~     ADHD because the intervention was designed with SMH provider input and has clear potential~     for widespread dissemination upon proof of efficacy.~   "
108240|NCT02150655|"~     The overall objective of this clinical pilot study is to determine at a random sampling time,~     the vaginal microbiome and metabolome of pregnant women, and to see if infection (bacterial~     vaginosis, vulvovaginal candidiasis, malaria) and exposure to environmental toxins affects~     could alter pregnancy and conception outcomes. It is hypothesized that infection and toxins~     will alter the vaginal microbiome and metabolome, increasing the risk of preterm labour and~     infertility in Rwandan women. In a sub-group of subjects, a preliminary assessment of the~     ability of orally administered probiotic lactobacilli to restore the vaginal microbiota to a~     healthy state and lower environmental toxins will be completed.~   "
108340|NCT02149342|"~     This pilot study compares two photosensitizers, hexylaminolaevulinate (HAL) and~     methylaminolaevulinate (MAL), in treatment of actinic keratoses. Study is conducted using~     randomized split-face design. Efficacy is assessed clinically, and histologically at 3 and 12~     months. Pain during and after treatments and adverse reactions at one week are recorded.~   "
108241|NCT02150642|"~     The investigators are interested in examining 1) the basic organization of spinal and~     cortical circuitry for the control of movement and 2) the influence of injury of these~     circuits. To investigate the neuronal circuitry, the investigators use various types of~     mechanical or electrical stimulation of the limbs, transcranial magnetic stimulation of the~     cortex and galvanic vestibular stimulation in both uninjured human subjects and subjects with~     a neurological injury (such as spinal cord injury, or Parkinsons's disease).~   "
108242|NCT02150629|"~     The study aims at discerning specific gait patterns and elucidating locomotor control of~     spinal cord injured patients in order to find sensitive kinematic and electromyographic~     outcome measures that are able to reveal information on underlying mechanisms of normal and~     aberrant gait control and its recovery over time. These measures may also be used to compare~     the outcome across different neurological disorders.~   "
108243|NCT02150616|"~     The purpose of this study is to investigate the effect of travelling to moderate altitude and~     of nocturnal oxygen therapy during a stay at moderate altitude on breathing and sleep of~     patients with pulmonary hypertension or with interstitial lung disease.~   "
108244|NCT02150603|"~     The purpose of this study is to examine the differences in perceived health, psychosocial~     functioning, behavioral outcomes and quality of life of adults with congenital heart disease~     who are living in different areas of the world, and how these differences can be understood~     (e.g., differences in sense of coherence or illness perceptions).~   "
108245|NCT02150590|"~     The purpose of this study is to investigate the effect of nocturnal oxygen therapy during a~     stay at moderate altitude on breathing and sleep of patients with chronic obstructive lung~     disease.~   "
108246|NCT02150577|"~     The objective of this Implementation Trial is to evaluate the implementation of evidence~     based practices for Bipolar Disorder and Treatment Resistant Depression in small rural~     Federally Qualified Health Centers. The evidence based practices chosen and adapted by Health~     Center providers and patients in consultation with clinical experts include: screening for~     and diagnosing Bipolar Disorder, prescribing mood stabilizers, on-line cognitive behavioral~     therapy, on-line peer support, collaborative care management and tele-psychiatry~     consultation. A quasi-experimental study design will be used, with each of the six~     participating Federally Qualified Health Centers choosing one implementation clinic and one~     control clinic. Implementation outcomes include: reach, adoption, implementation-fidelity and~     effectiveness. Providers and patients may choose to use all, any or none of the evidence~     based practices based on their needs and preferences. Data will be collected from chart~     review and patient surveys will be administered by an Interactive Voice Response telephone~     system.~   "
108247|NCT02150564|"~     Phase 3 randomized open labeled trials will evaluate the 3 D navigable ultrasound (SonoWand)~     in improving the extent of resection in intra-axial brain tumors. All patients will undergo~     resective surgery. In the experimental arm, a navigable 3 D ultrasound will be used. In the~     standard arm, only navigation will be used. This study will help in assessing the usefulness~     sononavigation in improving radicality of resection in malignant gliomas and also to access~     the accuracy of SonoWand in predicting residue (histopathological correlation).~   "
108248|NCT02150551|"~     In this trial, investigators will infuse donor bone marrow mesenchymal stromal cells~     intravenously, as a treatment for pediatric Crohn's disease or ulcerative colitis that has~     not responded to conventional therapies. The goals of this study are to test the safety and~     tolerability of donor mesenchymal stromal cells in children with Inflammatory Bowel Disease.~      Mesenchymal stromal cells support the development of blood cells within the bone marrow. When~     isolated from a donor and infused into an animal or human, they have been demonstrated to~     travel to areas of inflammation, to alter immune responses, to decrease pro-inflammatory~     cytokines, and to promote tissue repair. Infusion of these cells does not lead to rejection.~     These properties lead investigators to hypothesize that that these may be they may be~     beneficial in treating inflammatory bowel disease.~   "
108249|NCT02150538|"~     This study was designed to evaluate the potential benefits of treatment with biventricular~     device in patients with normal systolic function , indication for pacing and impaired~     atrio-ventricular conduction , by comparing the treatment with dual-chamber device . The REAL~     -CRT study is designed to test the hypothesis that, in patients with atrioventricular block~     of I degree and standard pacing indications , biventricular pacing is superior to single~     stimulation of the right ventricle (RV) with optimized algorithms for minimization of pacing~     , as assessed by echocardiography an endpoint defined in terms of maintenance over time of~     left ventricular ejection fraction (LVEF ) and left ventricular end-systolic volume ( LVESV )~     .~   "
108250|NCT02150525|"~     This randomized double-blind clinical trial studied the effect of oral omega-3 fatty acid on~     atrophic vaginitis in postmenopausal breast cancer survivors (N=52). Omega-3 fatty acid may~     reduce inflammation and improve vaginal symptoms in postmenopausal breast cancer survivors.~   "
108251|NCT02150512|"~     The purpose of this study, in mechanically ventilated septic shock patients, is to determine~     whether a fluid loading strategy based on parameters derived from the transpulmonary~     thermodilution technique may lead to more ventilator free days compared to a fluid loading~     strategy based on the surviving sepsis guidelines.~   "
108252|NCT02150499|"~     This is a study of levalbuterol tartrate HFA inhalation aerosol MDI in pediatric subjects~     birth to ≤ 48 months of age who go to the Emergency Department (ED) or their physician's~     office with an acute bronchospasm. Subjects presenting to the ED or physician's office with~     an acute bronchospasm must have a history of reactive airways disease, based on subjects'~     parent/guardian report.~   "
108253|NCT02150486|"~     To determine whether perioperative myocardial injury is associated with adverse outcome in~     patients scheduled for major abdominal surgery.~   "
108254|NCT02150473|"~     This study aims to compare longitudinally the effect of adalimumab plus methotrexate (MTX)~     versus MTX monotherapy on cartilage GAG content, reflected by Delayed Gadolinium-enhanced~     magnetic resonance imaging of cartilage (dGEMRIC) index, in patients with early progressive~     rheumatoid arthritis (RA), who had not previously received any Disease modifying~     antirheumatic drug (DMARD) or biologic treatment.~   "
108347|NCT02149251|"~     Records of women who had Pre-genetic diagnosis (PGD) over the last 3 years will be reviewed~     and its outcome will be compared to other records of women who had IVF/ICSI without PGD.~   "
108255|NCT02150460|"~     The aim of the study was to compare the efficacy and safety of single injection peribulbar~     anaesthesia against the classic double injection technique.~      This was a double blind randomized controlled trial involving two groups of consenting, adult~     Nigerian subjects with operable age-related cataract. An anaesthetic nurse who allocated the~     subjects to the two groups administered all the injections. The same surgeon operated on all~     the subjects while the principal investigator and a research assistant measured the outcome~     variables. All others were blinded as to subject allocation.~   "
108256|NCT02150447|"~     The aim of this study is the effect of proton pump inhibitor (PPI) with respect to gastric~     cancer bleeding in inoperable patients.~   "
108257|NCT02150434|"~     The aim of the current study was to evaluate a new system (FreeO2) that automatically~     titrates oxygen flow to maintain stable SpO2, in patients with moderate or severe chronic~     obstructive pulmonary disease during exercise. The investigators hypothesized that continuous~     automatic adjustment of the oxygen flows during exercise would better maintain patients~     within the oxygenation target, reduce episodes of desaturation and hyperoxia and would~     improve walking exercise tolerance in comparison with fixed levels of low-flow oxygen and~     with compressed air breathing.~   "
108258|NCT02150421|"~     The aim of the stuy is to investigate the effects of the adoption of a curriculum with~     electronic devices for teaching materials and textbooks in Hong Kong schoolchildren on their~     changes in refractive error and visual function.~   "
108259|NCT02150408|"~     Gastro-Entero-Pancreatic tumors (GEPs) are a subset of Neuroendocrine tumors (NETs) derived~     from the primitive gut and include digestive and bronchial NETs.~      Historically, the gold standard in their functional exploration is the conventional~     somatostatin receptors scintigraphy (SRS) labeled with Indium-111 (Octreoscan®). This~     reference imaging is complementary to Tomography (CT) and liver MRI. However SRS sensitivity~     is moderate (60 %), because of its intrinsic detection limits, which could delay the~     diagnosis or lead to inappropriate therapy.~      The use of somatostatin agonists (DOTATOC, DOTATATE, DOTANOC), radiolabeled with gallium-68~     (68Ga) enables targeting of Somatostatin receptors (SSTRs) with a PET resolution. This has~     improved diagnosis of TNE with a gain in sensitivity of over 20% compared to SRS.~     Furthermore, patient irradiation and imaging protocol are significantly reduced.~   "
108260|NCT02150395|"~     This study looks at the effects of a protocolized music therapy intervention on state anxiety~     for patients with cancer undergoing simulation for radiation therapy. Simulation, which is an~     imaging and diagnostic procedure, has been identified as producing significantly high levels~     of anxiety in many cancer patients.~   "
108261|NCT02150382|"~     China Rural Hypertension Control (CRHC) Project is a cluster randomized trial aims to test~     the effectiveness of a standardized protocol-based treatment program on hypertension control~     in rural China.~   "
108262|NCT02150369|"~     -Purpose: Phase I: To test the methods, data collection and analysis in a study to evaluate~     cognitive/affective/sleep symptoms in one patient undergoing treatment with high-dose~     Interleukin-2 (IL-2) for metastatic renal cell carcinoma (RCC), their informal caregiver and~     their primary nurse.~      Phase II: A pilot study examining up to 10 IL-2 cases to describe cognitive/affective/sleep~     symptoms of patients receiving high-dose IL-2 therapy for metastatic melanoma (MM) or~     metastatic RCC in order to develop interventional studies to minimize these symptoms.~      -Aims: In this pilot, a case is comprised of the metastatic RCC patient receiving IL-2, their~     care partner, and their primary nurse. The care partner for this study will be the family~     member or friend staying with the IL-2 patient throughout treatment.~      Phase I (Evaluation of Methods and Procedures):~      One case will be examined to evaluate the methods, data collection and analysis to be used in~     this study. The aims of Phase I of this study are to: Aim 1) Evaluate recruitment and~     enrollment procedures to enroll one IL-2 case, comprised of the IL-2 patient, their care~     partner and their primary nurse; Aim 2) Evaluate administration procedures, data collected,~     and analysis of four questionnaire scales to detect the trajectory of cognition [Attentional~     Function Index and Montreal Cognitive Assessment] and affect [Hamilton Anxiety scale and~     Inventory of Depressive Symptomatology‒Clinician] in the IL-2 patient from the start to the~     end of a cycle of treatment; Aim 3) Evaluate procedures, data collected and analysis of~     journal entries from the care partner who are to record their thoughts, observations, and~     feelings concerning any changes in the patient's behavior or cognition during IL-2 treatment~     every 8 hours; Aim 4) Evaluate procedures, data collected and analysis of semi-structured~     questionnaires completed by the primary nurse taking care of the patient receiving IL-2 which~     will describe any changes in behavior or cognition in the patient during their IL-2~     treatment; and Aim 5) Evaluate procedures, data collected and analysis of data of interviews~     with the IL-2 patient to further discern what symptoms endorsed on the measurement scales~     represent and how they are characterized, and interviewing the primary nurse to gain any~     additional data on cognitive/affective symptoms observed in the IL-2 patient.~      Phase II (Investigating Cognitive, Affective and Sleep Alterations in Patients Receiving high~     dose IL-2 therapy): Up to 10 additional cases will be enrolled to understand cognitive,~     affective and sleep symptoms induced from IL-2 therapy in oncology patients with MM or~     metastatic RCC, and help design future studies to ameliorate these treatment-limiting~     symptoms. The specific aims of this study are to: Aim 1) Describe cognitive (language,~     concentration, mental fatigue, confusion, attention, short-term memory, and orientation),~     affective (depression, anxiety, mood alterations), and sleep disturbance symptoms in patients~     receiving 1 to 4 cycles (up to 8-weeks) of high-dose IL-2 therapy. Aim 2) Examine observed~     patient experiences of cognitive/affective/sleep symptoms from each patient's primary care~     partner, and primary nurse during 1 to 4 cycles of IL-2 therapy. Aim 3) Describe the~     trajectories of cognitive/affective/sleep symptoms in patients with MM or metastatic RCC~     undergoing 1 to 4 cycles of IL-2 therapy. Not all patients will receive 4 cycles of IL-2,~     because treatment will depend on a) disease progression and b) side effect toxicity;~     therefore, the symptom trajectory will be described for the cycles completed in situations~     where all cycles are not completed.~   "
108263|NCT02150356|"~     Very few studies have evaluated the effect of aleurone-enriched grains on cardiovascular risk~     factors. Price et al.(2010) have shown that 4-week supplementation of aleurone-enriched~     products (27 g/day of aleurone) increased betaine concentration in plasma whereas reduced~     homocysteine and LDL-cholesterol levels. Interestingly, aleurone had no effect on total~     antioxidant status or endothelial function, whereas an improvement of C-reactive protein was~     observed (Price RK et al, 2012). It is not known whether consumption of more than 27g/day of~     aleurone-enriched products with higher ferulic acid biodisponibility and longer time of~     treatment could influence these parameters in individuals with metabolic syndrome.~     Noteworthy, no studies have investigated the effect of aleurone-enriched products on fasting~     and postprandial glycemic homeostasis and lipid metabolism. In addition, mechanisms by which~     aleurone may act in vivo are still unknown.~      The aim of this study is to investigate whether 8 weeks supplementation with~     aleurone-enriched products may influence glucose and lipid metabolism, incretin hormones~     levels, satiety, inflammation, oxidative stress and endothelial function in overweight/obese~     subjects with high cardiovascular risk.~   "
108264|NCT02150343|"~     The purpose of this study is to compare the treatment effect of three treatment regimens of~     HDM-SPIRE vs placebo and to evaluates the treatment effect of HDM-SPIRE on symptoms, rescue~     medication usage, Quality of Life and Sleep Quality~   "
108294|NCT02149953|"~     It is important that pregnant women eat an adequate amount of protein to ensure healthy~     growth and development of the fetus. Amino acids are the building blocks of the body's~     protein. Glycine is an amino acid that can be made in the body, but under certain metabolic~     circumstances (e.g. pregnancy) the body's needs may be higher and thus glycine must be~     obtained from the diet. Currently, it is not known how much glycine may be needed from the~     diet during pregnancy. We plan to study dietary glycine requirements in healthy pregnant~     women, during early and late gestation. We will do this using a modern, safe and quick~     method.~   "
108265|NCT02150330|"~     Diminished ovarian reserve (DOR) is one the challenge in the field of artificial reproductive~     technology (ART) while there is still no effective resolution of this disorder. In patents~     with DOR, the pregnancy rate is about only 2-4%. Eventually, patients with DOR turn to adapt~     children instead. In recent studies, dehydroepiandrosterone (DHEAS) supplement might play a~     role in reverse diminished ovarian reserve and improve the prognosis of ART. Cumulus cells,~     formed cumulus-oocyte complex (COC) with oocyte, play a important role in folliculogenesis,~     oocyte maturation, oocyte meiosis and ovulation. Growing evidences disclose there are~     crosstalks between oocyte and cumulus cells as paracrine regulations. Aberration the~     crosswalks between oocytes and cumulus cells would be associated with poor prognosis of~     folliculogenesis and further pregnancy outcomes. In patients under ovarian hyper-stimulation~     protocol, the assessment of cumulus cells might be reliable indicators of folliculogenesis,~     embryo development, pregnancy rate and pregnancy outcomes. These genes (indicators), such as~     Hyaluronan synthase（HAS2), Versican (VCAN), Thrombospondin 1 (THBS1), Runt-related~     transcription factor 2 (RUNX2), Chromobox homolog 3 (CBX3),Tripartite motif-containing 28~     (TRIM28), B-cell lymphoma 2 (BCL2)，BCL2-associated X protein (BAX). This study was assess the~     gene expressions of cumulus cells after the DHEAS supplement in patients with DOR under~     ovarian hyper stimulation protocol.~   "
108266|NCT02150317|"~     The aim of this study is to compare the outcomes of Transarterial Chemoembolization (TACE)~     followed by Sorafenib with TACE alone in patients with advanced hepatocellular carcinoma.~   "
108267|NCT02150304|"~     postdural puncture headache is a rare but serious complication of spinal anesthesia. many~     drugs were studied in prevention or treatment of that complication. However, there are~     limited numbers of trials about intravenous aminophylline for prevention. because of that we~     retrospectively aimed to investigate the effectiveness of aminophylline for postdural~     puncture headache in cesarean section.~   "
108268|NCT02150291|"~     Since success of the combination therapy with PEG-IFN and RBV is contingent on maintaining~     adequate doses of both drugs throughout the treatment period, the emergence of hematological~     side effects is expected and requires intervention. The hematological adverse effects lead to~     a trade-off between continuing the treatment with optimal dosage, to clear the virus,~     exacerbating thereby the side effects versus decreasing dosage to relieve severe anemia,~     reducing thereby the chances of achieving sustained virological response (SVR). Therefore, we~     aimed at giving Folic acid® and Neurobion® to HCV-infected patients during treatment with~     different types of PEG-IFN plus ribavirin in an attempt to evaluate its efficacy and safety~     as a prophylactic treatment to prevent hematological adverse effects. Preventing adverse~     effects without interfering with the therapeutic efficacy of different types of PEG-IFN plus~     ribavirin in HCV patients will lead to better health outcomes and improvement in their~     quality of life (HRQOL).~   "
108269|NCT02150278|"~     Objectives: The main objective of this pilot study is to assess the feasibility and~     effectiveness of a brief intervention to reduce drinking-driving behavior.~      Methods:~      Design: Pilot multicentre before/after intervention study without control group.~     Participants: We aim to recruit, from 01/01/2013 to 01/05/2013, 212 drivers aged 18 to 65 who~     declared to have consumed alcohol previous to driving, at least once in the past 30 days.~     Intervention: Brief behavioral intervention to reduce alcohol consumption before driving.~     Outcomes: Frequency of driving under the influence of alcohol in the past 30 days, regular~     alcohol consumption (Audit-C test), level of self-efficacy and stage of change according to~     the Prochaska and DiClemente's Transtheoretical Model of Change, sociodemographic variables,~     driver's profile, chronic pathologies, long -term medications, level of self risk perception.~     Information will be checked against medical record. Information on a) frequency of driving~     under the influence of alcohol in the past 30 days, b) regular alcohol and c) level of~     self-efficacy and stet of change according Prochaska State will be gathered at one month and~     12 month post intervention. Descriptive bivariate analysis to assess the distribution of risk~     elements associated to drinking-driving behavior.~      Potential impact expected: This pilot project will determine the feasibility of making a~     brief advice intervention in drivers under the influence of alcohol in primary care.~   "
108270|NCT02150265|"~     Background: There is need for more effectiveness studies concerning treatment of emotional~     symptom problems indicating anxiety and depression in adolescents. SMART is the only~     treatment manual for combined emotional disorders developed in Norwegian.~      Purpose: To find the best individualized treatment for adolescents with emotional~     difficulties by: Finding criteria for the selection of appropriate patients for treatment~     with cognitive-behavior therapy program SMART in an outpatient population (14-18 years).~     Finding predictors of completion of treatment program SMART. Examining the effects of~     treatment with the SMART program at 6 months follow-up.~      Design: A randomized controlled study in six outpatient clinics in the north of Norway. N=~     160 referred adolescents (14-18 years) with score above 6 on the Emotional Problems scale of~     the Strength and Difficulties Questionnaire (SDQ). Two thirds are treated according to the~     SMART-manual immediately, while the waiting list control group is treated with SMART after~     six weeks.~      Hypothesis: The SMART treatment is an effective treatment for emotional symptom problems.~      Publication: The results sought published internationally and nationally and will be~     communicated to clinicians.~   "
108295|NCT02149940|"~     Heart failure therapies (e.g. beta blockers) have been successful in decreasing mortality~     rates, as well as diminishing hospitalizations. Also, pharmacist collaboration has been shown~     to have a beneficial impact on heart failure related outcomes. Regardless, a high residual~     event rate is to be noted.~      In our pilot study, we wished to document whether a clinical pharmacist could still play a~     role in the heart failure management of an elderly inpatient heart failure population.~   "
108296|NCT02149927|"~     In imaging functional connectivity (FC) analyses of the resting brain, alterations of FC~     during unconsciousness have been reported. These results are in accordance to recent~     electroencephalographic studies observing impaired top-down processing during anesthesia. In~     this study, simultaneous records of functional magnetic resonance imaging (fMRI) and~     electroencephalogram (EEG) were performed to investigate the causality of neural mechanisms~     during sevoflurane anesthesia by correlating FC in fMRI and directional connectivity (DC) in~     electroencephalogram.~   "
111730|NCT02104973|"~     The purpose of this study is to design, implement and evaluate an intervention oriented to~     change alimentary practices and patterns of physical activity of children through educative~     activities with parents, teachers and children in school of Mexico city.~   "
108271|NCT02150252|"~     -  Clinical trial; Ischemic stroke; Bu-Yang-Huan-Wu Tang （BYHWT）; Gait parameter; Quality~          of life Stroke is the third of ten causing death disease constantly, and it also is~          third of consuming healthy insurance budget. There is 17,000 peoples disable due to~          stroke every year in Taiwan. Although ischemic stroke patient may use t-PA intravenously~          treatment within 3 hrs after stroke onset in modern medicine, and no others method may~          effect to treat ischemic stroke patients, thus, the study about stroke is an important~          issue. Bu-Yang- Huan-Wu Tang (BYHWT) has been became a main stream for the treatment of~          stroke after Qing dynasty Wang Qing-Ren theory that is BYHWT may treat stroke due to~          pattern of qi stagnation and blood stasis in traditional Chinese medicine. A number of~          researches report that BYHWT can reduce blood viscosity, anti-inflammation, enhancing~          neuronal regeneration and angiogenesis, but above-mentioned about BYHWT limit in the~          level of animal study and the scientific evidence is insufficiency in human trial.~          Therefore, the purpose of the present study was to investigate the therapeutic effect of~          BYHWT treating ischemic stroke by using a strict clinical trial.~        -  We designed a randomized, double blind, placebo-controlled study to assess the~          therapeutic effect of BYHWT treating ischemic stroke. The study expects to finish the~          assessment of 120 patients with ischemic stroke in three years. The study divided into:~          1) control group, receive placebo-BYHWT 3.0 g TID every day for continuously 6 weeks~          except ordinary medical care; 2) treatment group, the method is identical control group,~          but receive BYHWY. The main outcome was according to the changes of gait parameter~          including Speed, Cadence, Strike length, Gait cycle and Double support; and secondary~          outcome including the changes of Functional independence measurement scores and Barthel~          index scores, Ten Meters Walk Test, Short Physical Performance Batter, Berg Balance Test~          and WHO quality of life-brief (Taiwan Brief).~        -  We predict the results of the present can provide scientific evidence to proof BYHWT can~          improve neurological deficit and also can improve quality of life in patients with~          ischemic stroke.~   "
108272|NCT02150239|"~     Pain management is becoming an important ethical responsibility of the medical profession and~     a focus of the health care system. However, there are limited literature evaluate the~     postoperative pain experience and management in our local setting.~   "
108273|NCT02150226|"~     The objective of this work is to study in-mouth aging and LTD of monolithic zirconia~     restorations. Microstructural changes characteristic of LTD processes, wear, and clinical~     behaviour following standard parameters will be evaluated. Notably Raman spectroscopy and 3D~     laser surface analysis will be used, directly on the restorations, which will be removed at~     regular intervals.The working hypothesis is that LTD process is very slow at the scale at the~     lifespan of dental prostheses.~   "
108274|NCT02150213|"~     To provide medical follow-up to patients exposed to BGG492 for more than 28 days in study~     CBGG492A2207 (NCT 01147003) and/or CBGG492A2212 (NCT 01338805).~   "
108275|NCT02150200|"~     Hysterectomy is one of the most performed surgery in gynecologic surgery. Actually, 70 000~     hysterectomies are performed each year in France. Laparoscopic surgery is in progression. The~     percentage of hysterectomies performed laparoscopically is increasing. The advantage of~     laparoscopy include fewer infections, less operative pain, faster recovery time and shorter~     hospital stay. In France, the average of hospital stay after laparoscopic hysterectomy~     reduced to 3-4 days.~      The study hypothesis is that a shorter postoperative stay does not decrease the quality of~     life of the patients.~      This study will compare the evolution of quality of life (with a questionnaire concerning~     measuring health related quality of life the Euroqol EQ-5D) of patients discharged after 3~     days hospital stay to patients discharged the first day after a laparoscopic hysterectomy.~   "
108276|NCT02150187|"~     HCap Formula is composed of medicinal plants, vitamins and minerals. The purpose of this~     study is to evaluate the efficacy of HCap Formula, a nutrition supplement for promoting hair~     growth in men with tendencies for hair loss.~   "
108277|NCT02150174|"~     When people are tested on a previously learned material, they will latter remember it better~     even when compared to a condition where they can re-study it. This phenomenon is called~     retrieval practice and is supported by an extensive research literature mostly carried out in~     normal students. This paradigm begins to be used in cognitive remediation programs in~     patients suffering from memory difficulties.~      The objective of this study is to investigate whether retrieval practice is spared in~     patients with schizophrenia.~      If effective, this method could be used in cognitive remediation programs.~      Since episodic memory difficulties are supposed to be secondary to deficits in the~     initiation/elaboration of efficient encoding and retrieval strategies our hypothesis is that~     retrieval practice is spared in schizophrenia~   "
108278|NCT02150161|"~     The purpose of this study is to determine whether an infusion of lidocaine/ketamine compared~     to fentanyl is equivalent in anesthesia effectiveness and can help reduce the incidence of~     postoperative nausea and vomiting in patients undergoing elective hip arthroscopy surgery.~   "
108279|NCT02150148|"~     Cancer survivorship has been claimed a national priority, with a call to develop effective~     interventions that can prevent, delay, or mitigate the adverse effects and comorbidities in~     this high risk population. Strong evidence exists that a healthful diet and regular physical~     activity can prevent many chronic diseases and improve physical function. More research~     however is needed to develop interventions that can produce long-term adherence to healthful~     lifestyle behaviors. This pilot study is based on the hypothesis that vegetable gardening~     interventions will be feasible and result in improvements in diet and exercise behaviors as~     well as improvements in physical functioning and well-being.~   "
108280|NCT02150135|"~     Patients with pancreatic cancer often suffer from pain. Because of such a pain, their quality~     of life have seriously deteriorated. There have been a few studies that showed an effect for~     pain control by hyperthermia (heating the patient's body). However, there are several~     limitations in conventional hyperthermia. In this study, the investigators tried to show the~     effect of Oncothermia which is more selective to malignant tissue than conventional~     hyperthermia for pain control, increasing quality of life, and anti-tumor treatment.~   "
108297|NCT02149914|"~     Gastroesophageal reflux disease(GERD) mainly related to the reflux of stomach content induced~     by the dysfunction of lower esophageal sphincter. Proton pump inhibitors (PPI) can~     effectively block gastric acid secretion but the drug reactions and the degree of improvement~     in symptoms are sometimes unpredictable. The aim of this study is to investigate the~     association between the clinical efficacy of PPI in patients with GERD and the personal~     physical status by Ryodoraku and ANSWatch.~   "
108298|NCT02149901|"~     The specific aim of this study is to determine whether water ingestion potentiates the~     pressor response to pseudoephedrine in patients with primary disorders of autonomic failure.~     The study design will enable us to also evaluate the pressor response to water alone and to~     pseudoephedrine alone. In a secondary analysis, we will compare the results in patients with~     two autonomic disorders, pure autonomic failure (PAF) and multiple system atrophy (MSA). We~     hypothesize that drinking water following a dose of pseudoephedrine will lead to a greater~     increase in blood pressure than pseudoephedrine alone.~   "
108281|NCT02150122|"~     It is known that low vitamin D status is a very common problem in the UK. It is also known~     that a lack of vitamin D availability has potentially serious health implications, especially~     with respect to bone and muscle function. Much research has recently taken place to establish~     the vitamin D requirements of key population groups (i.e. pregnant women, the elderly, ethnic~     minorities). However few data are available describing the vitamin D requirements for male~     and female adolescents. The period of adolescence is a key stage of growth and development -~     poor nutrition during this time can have detrimental health consequences for a lifetime.~      No intervention studies have comprehensively investigated the vitamin D requirements of~     adolescents. The proposed ODIN Study will enable a better understanding of how adolescents~     respond to vitamin D supplementation and the most effective daily amount that will raise and~     maintain vitamin D status in adolescents during the winter-time. In addition, investigations~     into the mechanisms of action with respect to any differences observed across the doses of~     vitamin D and between the genders of the participants will also provide key information.~     Mechanisms of action will focus on genetic differences as well as differences in vitamin D~     metabolising enzymes.~      The results obtained from this significant study will not only inform the European Food~     Standards Agency (EFSA) with respect to their imminent deliberations regarding vitamin D~     recommendations. The ODIN Study will also inform the UK Department of Health's Scientific~     Advisory Committee on Nutrition (SACN), the wider scientific community and be a critical~     resource for key stakeholders (i.e. food industry, government health agencies) to collaborate~     in determining future public health strategies, thus potentially positively impacting on the~     health of the population for years to come.~      The investigators propose that the daily supplementation of 10µg/day (400 IU) and 20µg/day~     (800 IU) of vitamin D3 for five months will meet the vitamin D requirements of males and~     females aged 14-18 year and will be sufficient to maintain winter-time 25OHD levels above a~     range of thresholds between 30 and 50nmol/l.~   "
108282|NCT02150109|"~     The purpose of this study was to determine if untrained persons with diabetes and without~     diabetes could operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain~     valid blood glucose results.~   "
108283|NCT02150096|"~     The objective of this study is evaluate the laser and ultrasound effect on pain and~     disability in women with non-specific chronic low back pain.~   "
108284|NCT02150083|"~     Stress urinary incontinence (SUI) is a common condition that affects up to 35% of women. Many~     surgical procedures have been developed to treat SUI, and midurethral slings have gradually~     become the first line treatment. Voiding dysfunction, or inability for a patient to empty her~     bladder, immediately after surgery is common. A bladder test is often performed in the~     recovery area to see if the patient is able to empty her bladder. This typically consists of~     filling the bladder with 300 mL of saline through the foley catheter. The catheter is then~     removed and the patient is asked to void. The investigators then measure the voided volume~     and the residual left inside the bladder to determine if she is able to empty her bladder~     sufficiently or not. A successful voiding trial is defined as voiding 2/3 of the total volume~     in the bladder and having less than 100 mL left inside the bladder as residual. Our goal of~     this study was to evaluate efficiency and effectiveness of a retrograde postoperative voiding~     trial that is initiated in the operating room. Our hypothesis was that a retrograde~     postoperative voiding trial initiated in the operating room would be as effective as a~     standard retrograde postoperative voiding trial to predict postoperative voiding dysfunction~     while allowing for patients to spend less time in the recovery unit.~   "
108285|NCT02150070|"~     The purpose of this study is to determine the safety, tolerability, and pharmacokinetics (PK)~     after intravenous (IV) administration of ASP2408 manufactured from a new production clone and~     also following single ascending doses of subcutaneous (SC) injections of the same clinical~     trial material.~   "
108286|NCT02150057|"~     Subjects with symptomatic unicompartmental osteoarthritis of the knee will be invited to~     participate in this randomized study. Subjects will be assigned to either a Fusion~     Osteoarthritis Knee Brace group, or a control group that does not wear a brace. It is~     hypothesized that use of the Fusion Osteoarthritis Knee Brace will have a better outcome on~     osteoarthritis knee pain and quality of life compared to those who do not receive bracing~     intervention.~   "
108287|NCT02150044|"~     This was a non-significant risk (NSR), prospective, multi-center, single arm clinical trial~     that aimed to evaluate safety and performance of the Acclarent Tympanostomy Tube Delivery~     System (TTDS).~   "
108288|NCT02150031|"~     The first time the American Heart Association (AHA) suggested that disinfection of the~     gingival sulcus be performed as a complement to antibiotic prophylaxis in patients considered~     to be at risk of Infective endocarditis (IE) was in their protocol for the prevention of IE~     published in 1977. This practice was included by the AHA and adopted by other expert~     committees such as the British Society for Antimicrobial Chemotherapy (BSAC) in subsequent~     prophylactic regimens. In 1992, the BSAC specified the presentation and concentration of~     chlorhexidine (CHX) that should be used before starting the dental procedure: 1% gel at the~     gingival margin or 0.2% mouthwash for five minutes. In 1997, the AHA recognised the need to~     use antiseptic mouthwashes (CHX or povidone iodine) prior to dental manipulations, although~     they recommended against the use of gingival irrigators and against the continuous use of~     antiseptics in order to avoid the selection of resistant micro-organisms In 2006, the BSAC~     recommended a single mouthwash with 0.2% CHX gluconate (10 ml for 1 minute) before performing~     dental procedures associated with bacteraemia in patients at risk of IE. In contrast, in~     2007, the AHA recommended against the use of any antiseptic prophylaxis protocol.~      In 2008, the National Institute for Health and Clinical Excellence of the United Kingdom~     recently performed a systematic review of the antimicrobial prophylaxis protocols for IE and~     reported that: Oral chlorhexidine used as an oral rinse does not significantly reduce the~     level of bacteraemia following dental procedures. This conclusion was reached after analysis~     of numerous studies on the efficacy of prophylaxis with CHX for the prevention of post-dental~     manipulation bacteraemia. However, those studies presented significant methodological~     differences not only in the dental procedures performed, but also in the concentration of CHX~     applied and the method of application of the antiseptic solution (mouthwash and/or~     irrigation), making comparison of the results of the different series difficult.~      There are few studies that have analysed the efficacy of the mouthwash of 0.2% CHX (the~     concentration recommended by the BSAC) in the prevention of post-extraction bacteraemia. Only~     one study analysed the combination of local irrigation and mouthwash with chlorhexidine~     before dental extraction, but with a really lower concentration of CHX, only 0.02%.~      The objective of this study is to investigate the prevalence, duration and aetiology of~     bacteraemia secondary to a single tooth extraction after prophylaxis with different CHX~     protocols.~   "
108289|NCT02150018|"~     Effect of Non Invasive Ventilation on end-expiratory lung volumes determined by electrical~     impedance tomography~   "
108290|NCT02150005|"~     Objective: The aim of this study was to examine the effects of non-surgical periodontal~     treatment on the hemogram, glycemic and lipid profiles in cardiopathic patients with an~     indication for surgical revascularization.~      Materials and Methods: Twenty-two patients with chronic periodontitis, over 35 years of age~     (mean age 59.45 years) randomly assigned into 2 groups were evaluated. Test group (n=11),~     received periodontal treatment before the surgical procedure, and control group (n=11), did~     not received periodontal treatment prior to surgery.~   "
108291|NCT02149992|"~     Myo-inositol has been shown to decrease the rate of diabetes in pregnancy in European~     studies. It is not known exactly how this occurs or what it does to the sugar when the~     supplement is taken. This study purpose is to look at the patient's sugar levels while taking~     the supplement to see if the overall levels of sugar go down. We hypothesize that in addition~     to sugar levels, other hormones influencing diabetes will be altered.~   "
108292|NCT02149979|"~     The purpose of this study is to evaluate the safety and effectiveness of using Temperature~     Controlled Laser Soldering System for soft tissue bonding.~   "
108299|NCT02149888|"~     Canada continues to see an unrelenting stream of new HIV diagnoses, with a disproportionate~     burden among gay, bisexual, and other MSM in major centers such as Toronto. Pre-exposure~     prophylaxis (PrEP) with oral, daily tenofovir/emtricitabine (TDF/FTC, Truvada®) is a novel~     biomedical approach to HIV prevention shown in the iPrEx trial to be safe and efficacious in~     reducing HIV acquisition by 44% among MSM, when provided in a comprehensive package of HIV~     prevention interventions including counseling, testing/treatment of sexually transmitted~     infections (STIs), and condoms. There is now widespread mobilization to assess the~     feasibility of PrEP roll-out worldwide, with urgent calls for 'demonstration projects'~     addressing real-world PrEP implementation issues.~      PREPARATORY-5 is Canada's first PrEP demonstration project, and will examine real-world PrEP~     implementation issues including acceptability, effectiveness, impact on sexually transmitted~     infections, and strategies for supporting adherence outside the clinical trial setting. The~     investigators have also established a comprehensive community-based research program~     investigating the role of community-based organizations in PrEP implementation and delivery.~   "
108300|NCT02149875|"~     The investigators conducted a randomized, double-blind, trial enrolled 60 patients within 12~     hours of acute ischemic stroke (AIS) in China. Patients were randomly assigned to receive a~     10-day infusion of dl-3-n-butylphthalide (NBP) or cerebrolysin, or placebo. National~     Institutes of Health Stroke Scale (NIHSS) and Barthel Index (BI) were used to evaluate the~     efficacy in the patients with AIS at 11-day and 21-day after therapy. Adverse events were~     also analyzed among the three groups.~   "
108301|NCT02149862|"~     The purpose of this study is too assess infrared spectroscopy ability to discriminate urine~     of a patient affected by bladder cancer from urine of reference patient.~   "
108302|NCT02149849|"~     Up to 85% experience shoulder pain after thoracic surgery, especially on the same side as~     surgery are performed. Referred phrenic nerve pain is probably one cause of ipsilateral~     shoulder pain (ISP), and positioning of the arm during surgery another. Studies indicates~     that ISP can be caused by the positioning of the patient during surgery due to muscle -and~     ligament strain. Can a change in the surgical positioning (less press and stretch) of the~     ipsilateral arm effect the shoulder pain after thoracic surgery?~   "
108303|NCT02149836|"~     The purpose of this study is to test the antidepressant effects of Ezogabine in major~     depressive disorder (MDD). The investigators also aim to determine the safety and~     tolerability Ezogabine in patients with MDD. The investigators hypothesize that depressive~     symptoms will be significantly decreased following an 8-week treatment period of the~     medication compared to baseline.~   "
108304|NCT02149823|"~     Social cognition impairment is critical to the pathology and morbidity of a number of~     psychiatric disorders, including the schizophrenia spectrum, the autism spectrum and the~     personality disorders, thus representing a dimension consistent with RDoC. As such, this~     study aims to a) further characterize the unique deficits in social cognition (recognition~     and interpretation of social cues and representation of thoughts, intentions, and feelings of~     others) across disorders, including the schizophrenia spectrum (which includes schizophrenia,~     SCZ, schizoaffective disorder, SAD, bipolar disorder, BD, and schizotypal personality~     disorder, SPD), the autism spectrum disorders (ASD), and borderline personality disorder~     (BPD) compared to healthy controls (HC); b) assess the effect of intranasal oxytocin (OXT) as~     a regulator and novel treatment of social cognition impairment in these disorders; and c)~     enhance our understanding of the specificity and exact mechanisms of impairment to inform the~     accurate dosing of OXT required to modulate social cognition in these disorders and identify~     a model of optimum social cognitive function. Addressing these questions will further~     catalyze research into a model of optimum social cognitive activity, and accelerate industry~     development of agents suited to routine clinical administration.~   "
108305|NCT02149810|"~     Depression is a leading contributor to global burden of disease. Antidepressants do not~     provide adequate response for many patients. Mind-body therapies are often safe, increasingly~     embraced by patients albeit the limited good quality clinical trial data. The PI has shown~     that there is autonomic instability in patients with late life depression (LLD). Through his~     team of across discipline researchers he will investigate benefits of one adjunctive~     mind-body intervention, automatic self transcending meditation on autonomic instability in~     LLD and depressive symptoms compared to treatment as usual. If results are positive, such an~     intervention could be used for management of LLD across all levels of care.~      WHAT IS THE INNOVATION AND MAIN QUESTION/HYPOTHESIS UNDERLYING THIS PROPOSAL? The main study~     objectives are to assess heart rate variability (HRV), other autonomic parameters and~     depression scores in patients with late life depression undergoing an innovative mind-body~     therapy 'automatic self-transcending meditation' (ASTM) not previously evaluated in a~     randomized controlled manner in the treatment of late life depression:The investigators~     hypothesise that in patients with LLD treatment as usual(TAU) +ASTM will lead to a~     significant increase in HRV from baseline to end of study period as compared to treatment as~     usual TAU. The investigators also hypothesise that ASTM+TAU will cause a significant~     difference in other autonomic parameters including heart rate and blood pressure changes in~     presence of a physiological stress test (hand grip), depression and depression related~     pathologies such as anxiety and improve quality of life compared to TAU.~      It is expected that adding ASTM to TAU will be better than TAU in improving HRV, depression~     severity and other autonomic parameters in the treatment of LLD. It is expected that this~     intervention will produce significant anxiolytic and enhanced quality of life outcomes and~     will have no major side effects. If the results of this study are positive, it is possible~     that this intervention could be considered as treatment option for the management of this~     disabling illness in primary, secondary and tertiary care. Such treatment option would be~     more cost and staff effective, and self empowering than the current standard of care. It~     could also provide treatment options for patients who are currently resistant to their~     antidepressants.~   "
108306|NCT02149797|"~     Cholecystectomy is one of the most common operation performed by general surgeons. Since,~     first video-laparoscopic cholecystectomy in 1987, laparoscopic cholecystectomy (LC) has~     become the gold standard treatment for benign biliary disease. In daily practice, LC has~     increased general surgeons familiarity to video-laparoscopic operations and has become the~     first step to search more minimally invasive techniques and to perform advanced laparoscopic~     operations. In order to move forward the minimal invasive surgery concept with less surgical~     trauma and better cosmetic results, surgeons firstly reduced the number of incision and~     ports, then the idea of totally eliminating skin incisions through the use of natural~     orifices was implemented in selected cases.~      In theory, minimal incision must provide minimal postoperative pain and better cosmetic~     results. With the use of single-incision laparoscopic cholecystectomy (SILC), this purpose is~     achieved by means of cosmesis but providing minimal postoperative pain is still~     controversial. Recent reports on, LC vs. SILC showed significantly favorable cosmetic~     benefit, comparable complication rate and hospital stay with SILC, but the mean operation~     time was significantly longer. Today, lack of standardized operation technique, the need for~     specialized instruments, the fear of inability to apply safe cholecystectomy principles,~     longer operation time, cost-effectivity and advanced laparoscopic experience are still~     limiting factor to performing SILC.~      The aim of this prospective randomized controlled trial is to compare gold standard LC and~     SILC using our new technique called Pick'n roll (SILC-PR). Our goal was to provide critical~     view of safety and safe cholecystectomy principles on SILC, improve operator ergonomics and~     shorten operation time while eliminating the need for specialized instruments.~   "
108307|NCT02149784|"~     There is still no perfect treatment suggestion for patients with asymptomatic colorectal~     cancer with unresectable metastatic disease. Whether patients can benefit from palliative~     resection of primary tumor or not is still waiting for answer. The investigators hypothesis~     that asymptomatic metastatic colorectal cancer patients who respond to chemotherapy will~     benefit from primary tumor resection.~   "
108312|NCT02149719|"~     Peanut allergy is increasingly common, especially in countries such as UK and Australia.~     There is currently no accepted routine clinical therapy to cure peanut allergy. Recently~     studies have looked at desensitising people with peanut allergy by giving them small daily~     doses of roasted peanut. Although this therapy works for some people, its effects are not~     generally long lasting and it is associated with many side effects during protocol, resulting~     in a significant rate of drop-outs.~      Pilot data suggests that boiled peanut is less immunogenic than roasted peanut, and may~     therefore provide a safer way of inducing desensitisation in patients who are allergic to~     roasted peanut, by first inducing tolerance to boiled peanut.~      Study hypothesis: Increasing doses of boiled peanut can induce desensitisation to roasted~     peanut, in peanut-allergic individuals.~   "
108313|NCT02149706|"~     Multi-center, randomized , double-blind, placebo-controlled , two arm parallel design study~     of NeuroVax™ vs. Incomplete Freund's Adjuvant ( I F A) placebo. 150 subjects with Secondary~     Progressive SPMS.~   "
108314|NCT02149693|"~     Medical education was transformed from mainly didactic class before 19th century to the~     clerkship and internship training based on the concept of learning by doing in 20th~     century. There are new challenges for medical education in the 21th century, including~     knowledge explosion, the importance of communication and teamwork in clinical care, and lack~     of comprehensive and systemic experiential learning. Therefore, another paradigm shift of~     medical education in this century is necessary. This research project, through applying~     high-fidelity simulation, resuscitation teamwork model, and concept of flipped classroom in~     resuscitation training, take the innovation and reform of resuscitation training as a pilot~     test for paradigm shift of medical education.~      This research project is a 4-year project. Three innovative intervention for resuscitation~     training will be developed, implemented, and evaluated. There will be 4 phases in this~     project:~        1. Development phase (1st year): establishment of structure, validity and reliability test,~          faculty development, and course preparation.~        2. Experiment phase (2nd year): comparative studies will be conducted.~        3. Implementation phase (3rd year): integration and implementation of innovative~          interventions.~        4. Evaluation phase (4th year): effectiveness evaluation and analysis of learning~          retention.~      Through innovation, development, implementation and effectiveness evaluation in this 4~     phases, this research project hope to integrate high-fidelity simulation, resuscitation~     teamwork model, and concept of flipped classroom, into resuscitation training successfully~     and appropriately. Furthermore, these experiences can provide the bases of paradigm shift in~     medical education in the future.~   "
108315|NCT02149680|"~     Accidental dural puncture (ADP) during placement of an epidural catheter for anesthesia and~     analgesia is a well known complication. Previous studies have found audiometric deterioration~     following ADP. Epidural blood patch (EBP) is a common method for treating postural headache~     in patients with accidental dural puncture. In most cases, one-two patches are needed for~     successful management. Long-term effects of EBP on the incidence of backache, headache and~     early audiometric deterioration are few or non-existant. The present study aims to determine~     the long-term sequelae of EDP in parturients who had ADP and were treated with an EBP during~     the years 2005 - 2011.~   "
108316|NCT02149667|"~     Sponsor is conducting this post market clinical follow-up (PMCF) study to evaluate the safety~     and efficacy of its total hip arthroplasty (THA) components marketed in the European Union~     (EU) . These types of studies are required by regulatory authorities for all THA devices that~     do not have medium to long-term clinical evidence available at the time of gaining approval~     to market in the EU. This study has been designed in accordance with MEDDEV 2.12/2 rev 2.~   "
108317|NCT02149654|"~     Purpose To characterize the safety and clinical benefit of the Engager Transcatheter Aortic~     Valve Implantation System in a real world environment.~      Design Prospective non-randomized, non-interventional, multicenter, single-arm, post-market~     study.~      250 Patients will have the Engager bioprosthesis implanted. Patients will be followed at 1~     month, 6 months, and 12 months after the procedure. The recruitment period will be~     approximately 12 months, so the total study duration will be 24 months.~   "
108318|NCT02149641|"~     In the treatment of nasopharyngeal cancers, to determine the incidence of high grade (≥G2)~     subjective xerostomia at 1 year.~   "
108319|NCT02149628|"~     Robot assisted laparoscopic radical prostatectomy(Robot-LRP) requires pneumoperitoneum and~     trendelenburg position which result in oxidative stress and inflammatory response.~      Propofol is well known to reduce those responses during anesthesia. Therefore, we try to~     figure out the efficacy of propofol to reduce oxidative stress, inflammatory response and~     increase the nitric oxide activity during robot-LRP compared to that of desflurane.~      To investigate the oxidative stress, malondialdehyde will be measured. As inflammatory~     markers, interleukin-1β, interleukin-6, tumor necrosis factor-α will be measured. Nitric~     oxide will be measured as well.~      Secondarily, kidney protection effect of propofol over desflurane will be compared.~   "
108320|NCT02149615|"~     The exact incidence of optic disc swelling and idiopathic intracranial hypertension in~     patients using antiacne medication is not known so far. The investigators hypothesize that~     swelling of retinal nerve fibre layer measured by optical coherence tomography is more~     frequent then assumed so far.~   "
108321|NCT02149602|"~     This study is a phase II trial designed to test the feasibility of delivering IMRT to head~     and neck cancer patients with tumours arising in the midline (oropharynx and hypopharynx),~     and to assess possible improvement in reducing the incidence of xerostomia with bilateral~     superficial lobe parotid sparing IMRT.~   "
108322|NCT02149589|"~     To compare in ARDS patients 2 ventilatory Strategies : One based on Lung Morphology (Focal~     versus non-Focal ARDS) versus ARDS networks Guidelines (PEEP based on FiO2). In Focal ARDS~     prone position will be promote early, with low PEEP and moderate Vt. In non-Focal ARDS,~     Recruitment maneuvers, high PEEP and low V twill be used.~      The investigators made the hypothesis that ventilation according to Lung morphology my~     decrease mortality at D90.~   "
108341|NCT02149329|"~     A multicenter open-label non-inferiority randomized clinical trial comparing the safety~     (non-inferiority) of short antibiotic treatment (72 hours) with an anti-pseudomonal~     carbapenem with regard to treatment failure in comparison with extended treatment (at least 9~     days) of high-risk febrile neutropenia in hematology patients receiving standard~     antimicrobial prophylaxis.~   "
108323|NCT02149576|"~     After curative lung cancer surgery, there is a risk of recurrence of the primary cancer, or~     development of a new cancer. Historically, patients who have undergone curative lung cancer~     surgery have been monitored with chest radiographs (CXR). Unfortunately, 70% of such patients~     still die of lung cancer. As a result, there has been interest in other methods of~     surveillance in order to detect recurring or new cancers earlier and have more success in~     treating them. One such technique is Low Dose Computed Tomography (LDCT), which is currently~     the standard of care and surveillance at this institution. This pilot study aims to determine~     whether regimented, intensive, short interval LDCT surveillance leads to higher rates of~     detection and treatment of recurring lung cancers. The study group will be followed up~     according to a regimented surveillance program using LDCT. The study group will be compared~     to a group of historical controls whose follow up after surgery was not standardized, but~     rather left up to the discretion of the individual surgeon. If the results of this study show~     improvements in detection and treatment of recurrent cancers, it will allow for a larger~     trial to study the effects of the LDCT surveillance program on lung cancer survival.~      The study question aims to determine whether for survivors after curative surgery for Stage I~     and Stage II lung cancer, a structured Surveillance Program with Low Dose CT can increase the~     rate of detection and treatment of recurring or new cancers when compared to historical~     non-structured surveillance with CXR. This study will also determine if it is warranted to~     pursue a larger scale randomized controlled trial to further investigate optimal LDCT~     surveillance follow-up intervals and long-term lung cancer survival.~   "
108324|NCT02149563|"~     The major objective of the present study is to examine the influence of normobaric hyperoxia~     treatment on the symptoms of patients diagnosed with depression members of Clalit Health~     Services. The investigators hypothesize that normobaric hyperoxia treatment will improve the~     symptoms of patients with depression.~   "
108325|NCT02149550|"~     An effective vaccine against malaria is urgently needed to combat the scourge of this~     disease. Before candidate vaccines can be tested in endemic countries, they are first tested~     in human volunteers in so-called Controlled Human Malaria Infections (CHMI's). Ideally, a~     candidate vaccine should be tested against multiple strains of malaria, representative of the~     disease's global distribution. Recently we compared, for the first time, infections with the~     novel malaria strains NF135 and NF166 to those with the broadly-used and well-characterised~     strain NF54.~      The purpose of the current study is to optimise the course of infections with these novel~     strains by determining the minimum number of infectious bites necessary to reliably induce a~     malaria infection.~   "
108326|NCT02149537|"~     The vast majority of births with sickle cell disease (SCD) occur in Africa and 90% are~     thought to die before the age of five. Hydroxyurea (HU) is the only drug approved by the FDA~     for the treatment of sickle cell anemia. Although HU is used to treat small numbers of~     patients in Africa, cost, fear of toxicity, and lack of awareness and availability limit its~     use. The leukopenia that may be seen with HU raises the possibility of increased~     susceptibility to infection. Risk stratification - i.e., identification of patients most~     likely to benefit- could focus therapy and provide confidence that the risk:benefit ratio is~     favorable. Several clinical measures of future risk are well defined and findings on modifier~     genes in the US, primarily related to fetal hemoglobin (HbF), have further improved risk~     prediction. Whether the genetic variants predict severity in Africa is not known. The~     investigators have established a SCD cohort in Ibadan, Nigeria. In the first phase of this~     research the investigators will implement clinical risk examinations and assess the~     relationship between clinical characteristics (including levels of HbF) and known genetic~     markers. As a proxy for a birth cohort, the investigators will compare the frequency of the~     genetic markers in adult patients (i.e., survivors) to children. In the second phase the~     investigators will randomize 40 high risk adult patients to fixed low dose HU or no HU~     treatment in a crossover design and monitor hematologic and physiologic parameters to~     document hematologic effects and safety. This work will lay the basis for a large-scale trial~     to document safety and efficacy.~   "
108327|NCT02149524|"~     A Phase III Randomised, Double-Blind, Parallel Group, Multicentre Study to Compare the~     Efficacy, Safety, Pharmacokinetics and Immunogenicity between SB3 (proposed trastuzumab~     biosimilar) and Herceptin® in Women with Newly Diagnosed HER2 Positive Early or Locally~     Advanced Breast Cancer in Neoadjuvant Setting~   "
108328|NCT02149511|"~     In patients with chronic spinal cord injury, imaging of the spinal cord and brain above the~     level of the lesion provides evidence of neural degeneration; however, the spatial and~     temporal patterns of progression and their relation to clinical outcomes are uncertain. New~     interventions targeting acute spinal cord injury have entered clinical trials but~     neuroimaging outcomes as responsive markers of treatment have yet to be established. We aim~     to use MRI to assess neuronal degeneration above the level of the lesion after acute spinal~     cord injury. In our prospective longitudinal study, we enroll patients with acute traumatic~     spinal cord injury and healthy controls. We assess patients clinically and by MRI at~     baseline, 2 months, 6 months, and 12 months 24 months and 60 months, and controls by MRI at~     the same timepoints. We assess atrophy in white and brain matter and we use cross-sectional~     spinal cord area measurements to assess atrophy at cervical level C2/C3. We use~     myelin-sensitive magnetisation transfer (MT) and longitudinal relaxation rate (R1) maps to~     assess microstructural changes associated with myelin. We also assess associations between~     MRI parameters and clinical improvement.~   "
108329|NCT02149498|"~     A cornerstone in PD research is the investigation of neurophysiological changes as potential~     biomarkers that could help in tracking disease progression and response to therapies.~     Electroencephalography (EEG) could provide a non-invasive and relatively cheap tool for~     identification of such biomarkers. In this study we will use high-density~     electroencephalograph (EEG) recording, in order to develop a platform of biomarkers that~     could be more sensitive and reliable to disease progression and response to therapeutic~     intervention than standard clinical measures.~   "
108342|NCT02149316|"~     The purpose of this study is to determine whether remote ischemic preconditioning with~     postconditioning (RIPC+RIPostC) reduces myocardial injury and improves clinical outcomes in~     heart transplantation surgery.~   "
108343|NCT02149303|"~     This study is being conducted to collect data on the management of major bleeding events~     occurring in patients with atrial fibrillation taking dabigatran etexilate.~   "
108330|NCT02149485|"~     Since 1995, preimplantation genetic diagnosis (PGD) has been performed in The Netherlands for~     couples at high risk for transmitting severe or lethal genetic conditions or who have~     experienced multiple miscarriages due to chromosomal translocations. Approximately 260~     children have been born after PGD in The Netherlands. Follow-up data on children born after~     PGD are scarce. Long-term studies on PGD children have not been conducted in The Netherlands.~     Results of studies in other countries on 2-year old PGD children are reassuring. These~     children and their parents have normal scores on relevant parameters such as general health,~     cognitive and socioemotional development, parent-child interaction and parental stress.~     Studies of good methodological quality of older children have not yet been published.~      Objective: Long-term follow-up of children who have been born after PGD in The Netherlands.~     The primary aim is to assess the safety of PGD with regard to the health and development of~     the children.~      Study design: A cohort study. Study population: 5- and 8 year old children born after PGD in~     The Netherlands for various indications and their parents. Control groups consist of 5 and~     8-year old naturally conceived (NC) children of parents who have considered PGD treatment and~     5 and 8-year old children born after in vitro fertilisation/intracytoplasmatic sperm~     injection (IVF/ICSI), and the parents of the two latter groups of children.~   "
108331|NCT02149472|"~     Major obstetric haemorrhage (MOH) remains a cause of significant maternal morbidity and~     mortality worldwide. By identifying women with a higher a priori risk of major haemorrhage~     during their pregnancy or early during postpartum haemorrhage extra measures to prevent MOH~     can be taken.~      In this study the investigators aim to identify haemostatic parameters that during the course~     of haemorrhage are responsible for the on-going towards major bleeding. By doing this,~     cut-off points can be defined for future interventions aiming to stop this bleeding process~     in an early stage. Traditional coagulation parameters are currently not useful for clinical~     decision making, because of long turn around times. Therefore the added value of available~     coagulation 'point of care' tests will be evaluated during obstetric haemorrhage.These~     Point-of-Care (POC) tests could lead to a goal-directed haemostatic therapy for obstetric~     haemorrhage.~      A cohort of 9.500 pregnant women will be followed during their pregnancy and delivery. From~     all women a bleeding score will be obtained during their pregnancy by means of a validated~     questionnaire. The predictive value of this bleeding score for the occurrence of major~     obstetric haemorrhage will be evaluated.~      If postpartum haemorrhage develops (blood loss) > 1000 cc, blood samples will be drawn for~     conventional haemostatic parameters and ROTEM profiles. The pathway between minor bleeding~     and major bleeding will be elucidated. Interchangeability and comparability of conventional~     haemostatic parameters and ROTEM profiles will also be evaluated.~      The overall goal of the investigators is becoming more able to predict major obstetric~     haemorrhage in an early stage of postpartum haemorrhage and define thresholds for~     goal-directed hemostatic therapies.~   "
108332|NCT02149459|"~     Recurrent brain tumours are extremely aggressive and despite optimal treatment, median~     survival is less than two years. One of the standard treatment options in this situation is~     radiation therapy. Currently there is intense scientific interest concerning the abnormal~     energy metabolism in cancer cells. All cells require energy in order to function, obtaining~     'fuel' molecules such as glucose and fatty acids from the blood stream. Brain tumours exhibit~     metabolic reprogramming, meaning that their energy requirements and utilization of fuel~     molecules are quite different from normal cells. Brain tumour cells are exquisitely dependant~     on glucose as a source of energy. Animal studies have shown that when these tumours are~     deprived of glucose they are very sensitive to radiation therapy.~      In this clinical trial the investigators combine radiation therapy with a low-carbohydrate~     diet, in patients with recurrent brain tumours. In addition, subjects will receive medication~     with metformin, a drug usually used to treat diabetes. Metformin inhibits glucose metabolism~     within cancer cells, and additionally has reported intrinsic anti-cancer activity. Subjects~     will undergo advanced imaging and hormonal studies before, during and after the trial in~     order to obtain maximal translational-scientific impact.~      The hypothesis:~      The metabolic changes induced by the combination of a moderately-low carbohydrate diet~     combined with supplementary MCT and metformin therapy will selectively starve tumor cells.~     While normal brain cells are capable of deriving energy from ketone bodies during glucose~     restriction, tumor cells remain largely glucose-dependent for energy due to oncogene induced~     down-regulation of oxidative phosphorylation. While the tumor cells are in this 'vulnerable'~     state they will be less able to repair the damage induced by ionizing radiation.~      Short-term implementation of the metabolic intervention (i.e. combined diet and metformin~     therapy) prior to, during, and after hypofractionated (2 week) radiation therapy is expected~     to increase tolerability, increase compliance and avoid the chronic metabolic complications~     associated with extreme carbohydrate restriction diets.~   "
108333|NCT02149446|"~     Dividing pancreas when performing left-sided resections opens the risk for leakage from the~     divided end of the pancreas. Pancreatic juices could have a severe effect on surrounding~     abdominal tissues with abscess formation producing systemic inflammation and potential lethal~     bleeding.~      Studies have shown that reinforcement of the staple line when dividing pancreas could reduce~     the risk of leakage.~      Surgisis (COOK Medical) a product already in use for staple line reinforcement in gastric and~     lung surgery could be used as a reinforcement when stapling pancreas in left sided~     resections.~      In a prospective randomized trial we want to compare Surgisis reinforcement to no~     reinforcement of stapled division in left sided pancreatic resections.~      Primary outcome is pancreatic fistula yes/no.~   "
108334|NCT02149433|"~     This is a double-blind randomized controlled trial assessing the efficacy of adjuvant~     corticosteroids in clinically diagnosed Pneumocystis jiroveci pneumonia in infants.~   "
108335|NCT02149420|"~     This study is designed to evaluate the safety, tolerability, pharmacokinetics and therapeutic~     efficacy of a single intravenous infusion of VAY7346 monoclonal antibody in pSS patients~   "
108336|NCT02149407|"~     Feeding intolerance is a common problem in preterm infants.~   "
108337|NCT02149394|"~     The purpose of this study is to assess the efficacy of ice popsicle compared with water at~     room temperature in relieving thirst in the immediate postoperative period . The hypothesis~     of the study is that ice has 20% greater efficacy than water to relieve thirst in the~     immediate postoperative period.~   "
108338|NCT02149381|"~     A total of 384 patients suffering from chronic depressive disorder will be randomized to~     receive treatment as usual, CBASP, or befriending for a period of five months. The primary~     outcome is change in Montgomery-Åsberg Depression Scale. Secondary outcomes include changes~     in self-reported psychiatric symptoms, biomarkers determined from venous blood samples, and~     neurophysiological parameters. The data gathering is performed at pre- and post intervention~     stages (i.e., at baseline and at five months). A follow-up questionnaire is sent to the~     participants six months after the intervention.~   "
108339|NCT02149355|"~     Patients suffering from congenital fourth cranial nerve palsy may have misalignment of jaws~     as well as teeth due to head tilt in childhood.~   "
108348|NCT02149238|"~     Epidemiological studies suggest that certain foods rich in flavanols, including cocoa~     products, red wine, and tea, are associated with decreased cardiovascular mortality and~     morbidity. Dietary interventional studies have corroborated this finding and showed that~     flavanols can acutely and after sustained ingestion improve surrogate markers of~     cardiovascular risk including endothelial function. Endothelial dysfunction is the key event~     in the development and progression of cardiovascular disease. Aging is the major~     non-modifiable cardiovascular risk factor associated with progressive decline in endothelial~     function, vascular stiffening and increase in blood pressure.~      However, in addition to flavanols, other potentially bioactive compounds are present in~     cocoa, in particular methylxanthines. Little is known about the vascular effects of cocoa~     methylxanthines, i.e. mainly theobromine, in particular when consumed together with flavanols~     in cocoa products. The aim of the study is to characterize the nutrient-nutrient interaction~     between cocoa flavanols and cocoa methylxanthines.~   "
108349|NCT02149225|"~     The primary objective of this study is to assess the safety and tolerability, feasibility and~     biological activity (immunogenicity) of the actively personalized vaccination (APVAC) concept~     in newly diagnosed glioblastoma (GB) patients.~   "
108350|NCT02149212|"~     About 90 % of vascular symptoms affecting the lower limbs consist of venous diseases. Its~     highest incidence occurs from the second decade of life, affecting significantly the~     economically active population. Chronic Venous Insufficiency treatment aims to relieve~     symptoms, treat and prevent complications, prevent recurrences and provide cosmetic~     satisfaction with minimal side effects. It's current treatment includes some classic postural~     measures (leg elevation), elastic stockings and bandages compression therapy and possible~     medication (phlebotonics). The results in the medium and long term are unfavorable, since a~     large number of patients do not get better or evolves with recurrence of symptoms. Nowadays~     many, no prospective , not randomized , international studies have shown favorable results~     with endovascular treatment of obstruction in the iliac vein territory in patients with~     advanced Chronic Venous Insufficiency . The purpose of this prospective, double-blinded~     randomized study is to evaluate the results obtained with endovascular treatment, through the~     use of angioplasty and stenting in this group of patients when compared with clinical~     treatment .~   "
108351|NCT02149199|"~     The purpose of this study is to test if Symbicort® (budesonide/formoterol) Turbuhaler® is~     effective in treating asthma when used 'as needed' in patients with milder asthma. The~     efficacy of Symbicort® 'as needed' will be compared with: 1) terbutaline Turbuhaler® 'as~     needed' and with 2) Pulmicort (budesonide) Turbuhaler® twice daily plus terbutaline~     Turbuhaler® 'as needed'.~   "
108352|NCT02149186|"~     This project will build and test the first rehabilitation system employing virtual reality~     (VR)-based observation, motor imagery and execution to treat lower-limb neuropathic pain and~     motor dysfunction in participants with an incomplete spinal cord injury or another~     neurological disorder, eg. stroke: iCTuS-L (Interactive Computer-based Therapy System for~     legs). Patients using the system will control virtual representations of their legs to engage~     in entertaining gaming interactions.~   "
108353|NCT02149173|"~     This clinical trial studies use of F-18 16 alpha-fluoroestradiol ([F-18] FES) positron~     emission tomography (PET)/computed tomography (CT) in measuring tumor hormone receptor~     expression in patients undergoing endocrine-targeted therapy for newly diagnosed breast~     cancer or breast cancer that has come back or spread to other places in the body. Comparing~     results of diagnostic procedures done before, during, and after hormone therapy may help~     measure a patient's response to treatment.~   "
108354|NCT02149160|"~     The purposes of this study are to investigate the safety, tolerability, and pharmacodynamics~     of FRM-0334 in subjects with prodromal to moderate frontotemporal dementia with granulin~     mutation.~   "
108355|NCT02149147|"~     The purpose of this study is to investigate the variety of physical activity, a~     cross-sectional design will be used. The data collected will provide descriptive details~     about how people are engaging in physical activity, as well details about the environment~     they are in while engaging in physical activity.~   "
108356|NCT02149134|"~     Cow's milk protein allergy is defined as an immunological reaction to one or more milk~     proteins. A variety of symptoms can be suggestive for cow's milk protein allergy . Cow's milk~     protein allergy is suspected clinically in 5-15% of infants, while most estimates of~     prevalence of cow's milk protein allergy vary from only 2 to 5 %. Confusion regarding cow's~     milk protein allergy prevalence is often due to differences in study populations, study~     design and a lack of defined diagnostic criteria. The importance of defined diagnostic~     criteria needs to be emphasised. It precludes infants from an unnecessary diet and avoids~     delay in diagnosis, which can lead to malnutrition.~      There are two clinical types of cow's milk protein allergy: the immediate and the delayed~     type. The immediate type usually presents within minutes after the ingestion of cow's milk~     protein with urticaria, angio-oedema, vomiting or an acute flare of atopic dermatitis and is~     present in slightly more than half of the patients with cow's milk protein allergy. Delayed~     reactions such as atopic dermatitis or gastrointestinal symptoms like proctocolitis or~     enteropathy usually present after hours or days.~      Immunologically, cow's milk protein allergy can be IgE or non-IgE mediated. IgE mediated~     reactions are often of the immediate type. Non-IgE mediated reactions are often cell mediated~     or mixed cell and IgE mediated and are more difficult to prove by specific testing. The~     immunological reaction differentiates cow's milk protein allergy from other milk induced~     pathology such as lactose intolerance.~      A variety of symptoms can be suggestive for cow's milk protein allergy although none of them~     is diagnostic. A good medical history remains the cornerstone for the diagnosis.~      The treatment of cow's milk protein allergy is the dietary elimination of cow's milk~     proteins. In non-breastfed infants and children less than 2 years of age, a substitute~     formula is mandatory as prescribed by several international scientific societies. Extensively~     hydrolyzed formulas are used as therapeutic formulas. An extensively hydrolysed formula is~     often a whey or casein based formula in which the protein has been chopped up in smaller~     pieces that are less allergenic. Because of high cross-reactivity (up to 80%) and nutritional~     inadequacy, the use of any other animal milk or soy-based formula is precluded.The infant~     should be maintained on an elimination diet until the child is between 9-12 months of age or~     at least for 6 months, whichever occurs first. In most cases, symptoms will improve~     substantially within 2-4 weeks if diagnosis is correct.~      According to consensus in literature, a therapeutic formula is a formula tolerated by at~     least 90% (with 95% confidence) of cow's milk protein allergy infants.~      The aim of the investigators study is to show the efficacy, tolerance and nutritional~     adequacy of a newly developed thickened extensively hydrolyzed formula in infants with a~     proven cow's milk protein allergy. In all included patients, cow's milk protein allergy will~     have been diagnosed based on a double blind placebo controlled food challenge, considered as~     golden standard in cow's milk protein allergy diagnosis. To evaluate efficacy of the formula,~     the formula has to be tolerated by at least 90% (with 95% confidence) of cow's milk protein~     allergy infants following literature consensus. A symptom diary will be filled out for this~     purpose by the patients' parents or legal guardians and the patient will be followed~     clinically by his doctor several times during the study period.~      Nutritional adequacy of the formula will be evaluated clinically by following growth and~     weight several times during the study period and by comparing it to the standard WHO growth~     curves, based on breastfed infants.~   "
108357|NCT02149121|"~     This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10,~     Rituxan and MabThera in Patients with Rheumatoid Arthritis.~   "
108358|NCT02149108|"~     The objective of this Phase III study is to evaluate the efficacy of nintedanib in patients~     with metastatic colorectal cancer (mCRC) after failure of previous treatment with standard~     chemotherapy and biological agents.~   "
108359|NCT02149095|"~     TransCon PEG treprostinil is a novel prodrug form of treprostinil, in which treprostinil is~     reversibly conjugated via a four-arm branched polyethylene glycol (PEG) molecule. Reversible~     coupling of treprostinil to PEG should allow for a modified extended pharmacokinetic profile~     to achieve sustained plasma concentrations of treprostinil.~      This will be the first investigation of TransCon PEG treprostinil in humans. This study aims~     to determine the maximum tolerated dose (MTD) and assess the safety, tolerability and~     pharmacokinetics of escalating single doses of a subcutaneous injection of TransCon PEG~     treprostinil.~   "
108360|NCT02149082|"~     This is a study to determine whether the Near infrared spectroscopy (NIRS) optical density~     (OD) measurement with an Infrascanner device accurately identifies the presence of an~     intracranial hematoma in pediatric patients ≤18 years of age after known or suspected~     traumatic brain injury compared with head computerized tomography (CT) scans as the gold~     standard.~   "
108361|NCT02149069|"~     A care path in the field of transfusion medicine was creates at ASMN - IRCCS addressed to~     patients undergoing complex surgical procedures.~   "
108369|NCT02148965|"~     The Pamela Study is a clinical trial carried out during pregnancy to assess the potential~     effects of physical activity during pregnancy among previously inactive women. The trial is~     nested into a birth cohort of more than 4000 dyads (mother-child) and took place in Pelotas,~     Brazil.~   "
108370|NCT02148952|"~     The purpose of this study is to measure the impact of a checklist-based childbirth safety~     program (the WHO Safe Childbirth Checklist Program) on reduction of severe maternal, fetal,~     and newborn harm in institutional deliveries in north India.~   "
110551|NCT02120417|"~     This was a randomized, double-blind, placebo-controlled phase 2 clinical trial comparing the~     overall survival of women with advanced or metastatic HER2-negative breast cancer who~     received treatment with capecitabine in combination with ruxolitinib versus those who~     received treatment with capecitabine alone.~   "
108362|NCT02149056|"~     Background About 2/3 patients of coronary heart disease (CHD) are complicated with disorder~     of carbohydrate metabolism which results in hyperglycemia and subsequent abnormality of~     coagulation system and inflammation. These patients have serious coronary artery pathology,~     multiple complications and poor prognosis. Platelets and lymphocytes play important roles in~     the occurrence and progression of atherosclerosis. The platelet/lymphocyte rate (PLR) is one~     simple hematological index. Previous studies confirmed that PLR could predict the long-term~     mortality of non-ST elevated myocardial infarction (NSTEMI). If simple hematological index~     could predict the prognosis of such kind of patients, it will provide new thought for early~     diagnosis and treatment in future. Therefore, the present study try to investigate if PLR~     could predict the poor prognosis of CHD patients complicated with impaired glucose tolerance~     (IGT) through calculating PLR.~      Methods/design The present study is performed with strategy of an observational and~     prospective single-centre cohort. These patients are recruited from August 2013 to August~     2014, according to the inclusion criteria of CHD complicated with IGT. CHD is confirmed with~     coronary angiography while IGT is determined according to the WHO criteria (1999). Routine~     blood test and serum glucose data of patients are acquired before hospitalization and~     surgery. According to the median of PLR after admission, the patients are divided into 3~     groups. The patients are followed up for half, 1 and 3 years, respectively. The major~     clinical endpoint is mortality. The minor clinical endpoint indices are the correlations of~     PLR with MACE (including mortality, recurrent rate of infarction and reperfusion rate of~     target vessels), recurrent infarction, re-perfusion rate of target vessel, intra-stand~     thrombogenesis, stroke and acute onset of heart failure. The correlations are analyzed with~     receiver operating characteristics (ROC) survival curve and Kaplan-Meier survival analysis to~     find optimal prognosis index.~      Summary Through regression analysis of long-term follow-up of patients, it is expected to~     find optimal predicting index of prognosis. While judging whether PLR is effective, other~     possible factors for new predictor are sought in order to provide help for future study.~   "
108363|NCT02149043|"~     Ulcerative colitis represents a chronic condition occurring in relapsing and remitting~     fashion with uncertain outcome and requires lifelong treatment with considerable side~     effects. Diagnostic methods currently in use, clinical (endoscopy), imaging (CT, MR) or~     laboratory (C - reactive protein, calprotectin) give an insight into disease activity, but~     are possibly associated with significant discomfort for the patient and / or increased risk~     of irradiation and potential allergic reactions on contrast agents. For that reason there is~     a need for a noninvasive, biologically inert method for evaluation of disease activity in~     inflammatory bowel disease (IBD). Thermography possesses most of these characteristics. The~     aim of this study is to find potential link between pathological thermographic signs and~     endoscopic findings, serum C reactive protein (CRP) and calprotectin in the stool of patients~     with active and extensive ulcerative colitis.~   "
108364|NCT02149030|"~     The main objective of the study is to identify whether or not being informed infrequently~     results about screening is: 1) At least as safe and accurate as frequently obtaining all~     information from the present combination of opportunistic/organized cervical screening by~     comparing regimen results of three screening visits at the ages of 22, 25 and 30 years (Arm~     A1) vs. results of one screening visit at the age of 30 years (Arm A2) in Human~     papillomavirus (HPV) vaccinated young women.~   "
108365|NCT02149017|"~     To evaluate pharmacokinetics, safety and efficacy of SNUBH-NM-333(18F), a new diagnostic~     radiopharmaceutical for PET imaging of amyloid plaques, in Alzheimer's disease patients and~     healthy volunteers.~   "
108366|NCT02149004|"~     Despite major advances in therapy and management, HIV/AIDS continues to be a major cause of~     infectious disease morbidity and mortality on a global scale. The discovery of effective~     antiretroviral treatment has turned HIV infection into a manageable chronic disease in most~     patients with access to care. However, the different economic and epidemiologic situation in~     developing and developed countries requires different research priorities, so that three main~     challanges are universal and in focus of research of the DZIF HIV Translational Platform:~        -  Prevention of HIV infection~        -  Long-term life with HIV~        -  HIV cure~      The Translation Reserach HIV will bring together clinical researchers in HIV infection in~     order to develop new treatment options to the above mentioned main challanges. It will take~     advantage of existing expertise (e.g. basic science, novel targets for treatment and HIV~     eradiation) of the partner sites. This platform is necessary because Germany's HIV research~     has suffered in the past from a lack of integration between its excellent basic science and~     clinical research. In addition, there was too little integration into networks that address~     the main international challenges. There is an urgent need to link these research strands~     through dedicated structures emphasising the translation of preclinical results into new~     therapies.~   "
108367|NCT02148991|"~     Arterial hypertension causes adverse effects on the entire cardiovascular system, with~     effects centrally such as diastolic dysfunction and structural changes of the left ventricle~     and, peripherally such as endothelial dysfunction and increased thickness of the vessels.~      Co-existing diseases, such as diabetes mellitus, renal dysfunction, sleep apnea, etc. further~     aggravate the prognosis of these patients.~      In addition the rate of patients aged > 65 years suffering from un-diagnosed or diagnosed~     arterial hypertension was 78% for women and 64% for male patients. This population consists~     from elderly or very elderly patients (over 65 and 80 years respectively) who exhibit more~     comorbidities and probably less compliance with antihypertensive therapy. Finally, at every~     age the disease and its effects can affect the quality of life of patients.~      The main purpose of this study is to investigate the efficacy of antihypertensive therapy~     (irbesartan alone or in combination with amplodipine and carvedilol) on the cardiovascular~     system (diastolic left ventricular function, the function of the endothelium (FMD) and the~     thickness of the common carotid artery).~      The secondary objective of the study is to monitor the quality of life (Quality of Life -~     QoL) of patients.~      Additionally the investigators will seek the correlation of results with co-morbidities,~     compliance, and patient age.~   "
108368|NCT02148978|"~     Cystic Fibrosis (CF) is a chronic disease characterized by recurrent pulmonary infections and~     exocrine pancreatic insufficiency. The vast majority of patients with CF will develop~     pancreatic endocrine insufficiency over time manifested as altered glucose metabolism. The~     presence of overt diabetes in patients with CF is associated with adverse clinical outcomes.~      The underlying pathophysiology of cystic fibrosis related diabetes (CFRD) is still a matter~     of investigation. In addition to localized tissue damage developing similar to that of the~     exocrine pancreas, additional mechanisms may be involved. The investigators have recently~     shown that insulin secretion in patients with CF is significantly altered prior to the~     development of diabetes. This phenomenon is associated with reduced secretion of gut derived~     incretins (specifically GIP). The blunting of incretin induced insulin secretion (whether due~     to a deranged interaction of gastrointestinal contents with enterocytes resulting in reduced~     secretion or due to rapid clearance of such peptides) may be a major underlying driver of~     altered glucose metabolism in such patients.~   "
108371|NCT02148939|"~     Many patients suffer from acute and chronic pain. The incidence of chronic pain correlates~     with increased age. Most of patients rely on analgesic medication to control the pain.~     Dipyrone is an extensively used drug in Western and Eastern Europe as well as Central and~     South America, largely due to its favorable analgesic and antipyretic effects in conjunction~     with a low incidence of gastrointestinal complications when compared to other non-steroidal~     anti-inflammatory drugs (NSAIDs).~      Aspirin is the backbone of antiplatelet therapy in patients after ischemic stroke. However,~     it is known that there are substantial inter-individual response variabilities to~     antiplatelet medication. Furthermore, patients with impaired response to aspirin have a~     significant higher risk of recurrent cerebrovascular events. The investigators have recently~     shown that co-medication with aspirin and dipyrone in patients with coronary artery disease~     lead to insufficient antiplatelet effects of aspirin.~      The incidence of chronic pain is very high in patients with ischemic stroke. Therefore, in~     this study the investigators aim to examine, if co-medication of aspirin and dipyrone~     interaction also occurs in patients after ischemic stroke.~   "
108372|NCT02148926|"~     This study is a descriptive study to investigate clinical and genetic features of dilated~     cardiomyopathy (DCM) patients and their relatives. 109 probands with DCM have been clinically~     characterized with clinical examinations including ECG and echocardiography, and furthermore~     they have had next generation sequencing (NGS) of 42 known DCM genes, and 34 candidate genes.~     The probands were consequtively included in the study and 59 had undergone heart~     transplantation (HTx) upon inclusion. of these patients underwent heart transplantation. The~     data from NGS is validated by Sanger sequencing. In this study we will examine the relatives~     to the 109 index patients by genetic and clinical cascade screening including advanced~     echocardiography including 3D volume measurements and speckle-tracking (GLS). Genetic~     investigations of relatives will be performed if a disease-associated mutation is identifed~     in the proband. Approximately 480 clinical examinations will be performed this way to be able~     to:~      1a. Investigate the frequency of familial types of DCM~      1b. To investigate the yield of genetic and clinical cascade screening~      2. To describe genotype phenotype correlations~      3. To investigate if there are subtle changes in the heart in genopositive individuals which~     do not meet the conventional diagnostic criteria evaluated by advanced echocardiography.~   "
108373|NCT02148913|"~     This is a phase I clinical trial. Patients with a diagnosis of multiple myeloma undergoing~     autologous transplantation will receive a preparative regimen of melphalan, bendamustine, and~     carfilzomib. We hypothesize that the addition of carfilzomib to a conditioning regimen of~     melphalan and bendamustine in the setting of autologous transplantation for multiple myeloma~     is feasible and safe.~   "
108374|NCT02148900|"~     The objective of this study is to determine whether a simple blood test can be a useful~     clinical tool for monitoring aortic disease in Marfan syndrome and Marfan-related disorders.~   "
108375|NCT02148887|"~     We aim to investigate the effect of motor skill training of the upper and lower limbs on the~     function and structure of the CNS as measured by neuroimaging parameters sensitive to changes~     in tissue volume and density and the properties of myelin.~   "
108376|NCT02148874|"~     This study will examine effects of everyday life stress and obesity on immune responses to~     influenza virus vaccine (the flu shot) during pregnancy. Following vaccination, antibody~     levels against influenza (the flu) increase. Higher antibody levels indicate better immune~     protection from influenza. In addition to providing protection from the flu for yourself,~     being vaccinated during pregnancy may protect your baby from the flu during the first six~     months of life during which time infants cannot be vaccinated. Our primary goals are to~     determine whether greater life stress and obesity reduce 1) antibody responses to the flu~     shot in women and 2) antibody levels in the newborn at the time of delivery.~   "
108377|NCT02148861|"~     This trial is conducted in Europe. The aim of the trial is to investigate the safety,~     tolerability, pharmacokinetics (the exposure of the trial drug in the body) and~     pharmacodynamics (the effect of the investigated drug on the body) of subcutaneously~     administered NNC0148-0287 (insulin 287) in subjects with type 2 diabetes~   "
108378|NCT02148848|"~     Femoral neck fracture in the elderly is one indication for initiating osteoporosis treatment.~     Bisphosphonates remain the first line therapy; however, many orthopaedic surgeons concern~     regarding their effects on fracture healing process. Therefore, therapy is usually delayed~     for a period of time. To the best of our knowledge, there is no scientific data to support~     whether bisphosphonate treatment should be given immediately after the surgery or it should~     be delayed.~   "
108379|NCT02148835|"~     New approaches to increase eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in our~     diet are needed, but any new approach needs to demonstrate the bioavailability of EPA+DHA,~     and its safety and palatability. The HS-Omega-3 Index is a prime parameter to demonstrate~     bioavailability in the long-term. Study hypothesis is that increased intake of EPA+DHA will~     increase the HS-Omega-3 Index. Study aim is to investigate how supplementing various sausages~     with omega-3 fatty acids influences the HS-Omega-3 Index in healthy volunteers, as compared~     to unsupplemented matching sausages. Safety and palatability of the sausages are also to be~     assessed.~   "
108380|NCT02148822|"~     The project Visceral Leishmaniasis and Malnutrition is a cohort study that aimed to assess~     the association between malnutrition and visceral leishmaniasis (VL). It was conducted in~     Libo Kemkem and Fogera districts of the Amhara Regional State in Ethiopia. Clinical,~     anthropometric, biochemical, immunological, parasitological and sociodemographic data of~     school age children from VL high prevalence communities were collected in December 2009, May~     2010 and February 2011.~   "
108381|NCT02148809|"~     Hypotensive Anesthesia is a type of regional anesthesia performed routinely at our hospital.~     This type of anesthesia reduces the average arterial pressure. Benefits include reduced~     bleeding and lower risk of blood clots.~      The purpose of this study is to determine the effect of intravenous fluids administered with~     hypotensive anesthesia on your blood volume. With this parameter we will be able to~     understand how much of your blood is lost because of bleeding and how much of the drop is~     related to dilution.~      Study hypothesis: Hemodilution associated with intravenous fluid substitution during~     hypotensive anesthesia results in decreased postoperative hemoglobin (Hb) levels~   "
110552|NCT02120404|"~     The purpose of this study is :~      - to evaluate the hemodynamic tolerance of esmolol titrated to obtain a lowering of heart~     rate of 10% or 20%.~   "
108383|NCT02148783|"~     Deficits in memory, attention, cognitive, and executive functions are the most common~     disabilities after traumatic brain injury (TBI). Dopamine (DA) neurotransmission is~     implicated in these neural functions and dopaminergic pathways are recognized to be~     frequently disrupted after TBI. One of the most widely used DAergic drugs is methylphenidate~     (Ritalin®). Methylphenidate increases synaptic DA levels by binding to presynaptic dopamine~     transporters (DAT) and blocking re-uptake. PET with methylphenidate challenge to measure~     tonic DA release provides valuable insight into the molecular basis of attention-deficit~     hyperactivity disorder (ADHD) and addiction, as well as practical information regarding~     likely effectiveness of therapy (1). The objectives of this study are to use PET imaging with~     [11C]-raclopride, a D2/D3 receptor ligand, before and after administering methylphenidate, to~     measure endogenous DA release in patients who are experiencing problems with cognition,~     attention and executive function in the chronic stage after TBI. In addition, we will use TMS~     to test short intracortical inhibition, a gamma-aminobutyric acid receptor A (GABAA) -~     mediated phenomenon, which is under partial DA control, as a measure of dopaminergic activity~     on and off methylphenidate.~   "
108384|NCT02148770|"~     Neuroimaging is becoming increasingly common to investigate the neural networks underlying~     eating behaviour and food preference in normal-weight and obese humans. It has been observed~     that obese in comparison to lean individuals display altered activation patterns in networks~     of brain areas involved in reward, emotion and cognitive control. Interestingly, obese~     individuals who are capable of losing weight appear to have a stronger connectivity between~     areas related to food value and to the control of eating behaviour. The same areas are also~     associated with healthy food choices. It has been suggested that activation in the prefrontal~     control areas indirectly modulate valuation-related activity. Based on this, brain-related~     intervention strategies to support weight loss and long-lasting weight maintenance are of~     particular interest. Hence, we first want to examine the effect on eating behaviour of~     neurofeedback training-induced up-regulation of functional connectivity between reward- and~     impulse-related brain areas as a pilot, and second we want to examine up-regulation of the~     activity of prefrontal control brain areas.~   "
108385|NCT02148757|"~     Purpose of this study is to determine the incidence of deep venous thrombosis after partial~     knee replacement.~   "
108386|NCT02148744|"~     This first-in-human (FIH) study is a randomized, double-blinded, placebo-controlled,~     ascending dose study to investigate the safety, tolerability, and pharmacokinetics of~     XmAb7195 in adult healthy volunteers and in adult subjects with elevated IgE levels.~   "
108387|NCT02148731|"~     MOST is a longitudinal study whose aim is to test the hypothesis that frailty markers are~     better at detecting vulnerable patients and that they are a better Adverse Events~     predictive tool than the CGA (Comprehensive Geriatric Assessment) in older cancer patients~     referred for chemotherapy. The second hypothesis is that a brief screening tool based on a~     combination of some frailty markers and some used in the CGA would help the oncologist detect~     patients requiring a more complete geriatric assessment~   "
108388|NCT02148718|"~     The purpose of this study is to evaluate the rapidity of onset of clinical response to~     adalimumab therapy in patients with luminal Crohn's disease.~   "
108389|NCT02148705|"~     This study will be a three-arms study intending to demonstrate superiority of NexoBrid~     treatment over the Gel Vehicle placebo control treatment and over SOC in thermal burn~     subjects.~      The study objectives are:~        1. To demonstrate the efficacy of enzymatic eschar removal with NexoBrid by providing~          complete eschar removal as compared with Gel vehicle,~        2. To demonstrate the efficacy of enzymatic eschar removal with NexoBrid by providing~          earlier complete eschar removal, reduction in patients' surgical burden and its related~          blood loss as compared to SOC,~        3. To assess the safety of NexoBrid compared to SOC, including demonstration that treatment~          with NexoBrid does not cause an unacceptable level of harm on wound closure outcome and~          long term outcomes of cosmesis and function.~   "
108390|NCT02148692|"~     Postoperative respiratory failure, particularly after surgery under general anesthesia, adds~     to the morbidity and mortality of surgical patients. Anesthesiologists inconsistently use~     positive end-expiratory pressure (PEEP) and recruitment maneuvers in the hope that this may~     improve oxygenation and protect against postoperative pulmonary complications (PPCs),~     especially in obese patients. While anesthesiologists tend to use PEEP higher than in~     non-obese patients. While it is uncertain whether a strategy that uses higher levels of PEEP~     with recruitment maneuvers truly prevents PPCs in these patients, use of higher levels of~     PEEP with recruitment maneuvers could compromise intra-operative hemodynamics.~      The investigators aim to compare a ventilation strategy using higher levels of PEEP with~     recruitment maneuvers with one using lower levels of PEEP without recruitment maneuvers in~     obese patients at an intermediate-to-high risk for PPCs.~      We hypothesize that an intra-operative ventilation strategy using higher levels of PEEP and~     recruitment maneuvers, as compared to ventilation with lower levels of PEEP without~     recruitment maneuvers, prevents PPCs in obese patients at an intermediate-to-high risk for~     PPC.~   "
108391|NCT02148679|"~     Study subjects will receive either pre-prepared, home-delivered DASH/SRD-compliant meals or~     attention control for 4 weeks after hospital discharge.~   "
108392|NCT02148666|"~     One of the challenges of stem cell therapy is to understand the fate of the injected stem~     cell. By labelling various stem cells with radioisotopes their fate (homing) can be~     demonstrated. In this study, we will develop and refine the existing techniques of stem cell~     labelling to various subtypes of stem cells namely- freshly aspirated bone marrow cells,~     cryopreserved bone marrow cells, g-csf mobilized peripheral blood stem cells and umbilical~     cord cells. After testing the labelling efficacy and viability, these cells will be injected~     in to the coronary arteries of patients with myocardial infarction who have undergone a~     successful revascularization either by angioplasty or thrombolysis. Homing of stem cells will~     be demonstrated by nuclear scan after the procedure. We are adapting techniques used to label~     cells for detection of infection and bleeding using nuclear scans for in vivo scanning. Also~     we are using Technetium instead of FDG which has very little radioactivity allowing us to~     work with the current cardiac labs with out having to reconstruct the labs with special~     shielding for radioactive compounds. Real benefit of stem cells then can be explored after~     demonstrating the proper homing.~   "
110553|NCT02120391|"~     The purpose of this study is to assess an iPhone application to increase adherence to~     maintenance medications in subjects with ulcerative colitis.~   "
108393|NCT02148653|"~     Main scientific question:~      A previous intervention with an anti-inflammatory multifunctional dietary portfolio (MFD)~     showed remarkable reductions in cardiometabolic (CM) risk markers compared with a~     well-designed control diet. The study was performed under weight maintenance conditions in~     healthy subjects in a 4w crossover design (Tovar et al., 2012). MFD consumption also resulted~     in improved cognitive performance after 4 weeks (Nilsson et al., 2013).~      The present project will further study the preventive potential of MFD, using its unique~     properties for identification of new biomarkers and to evaluate the potential role of~     alterations in the gut microbiota. MFD will be tested in healthy at risk subjects in a~     randomized parallel design in an eight-week intervention with the test or control diet,~     respectively, allowing for weight loss. Assessment of standard anthropometric/biochemical~     markers of CM risk, metabolomics analysis and appetite regulating hormone evaluation are also~     planned. Associations between the gut microbiota composition and measures of CM risk are also~     included. The project provides unique opportunities to identify mechanisms for the metabolic~     impact of MFD, for further exploitation in innovative food and/or dietary concepts.~      Central hypothesis:~      The CM-preventive potential of MFD may be boosted in a medium-term trial under conditions~     allowing for body weight reduction. Expected additional benefits may be recorded as reduced~     values for conventional CM-related parameters, markers of modified gut microbiota composition~     and specific changes in blood metabolite profiles.~      Objectives:~        -  To further improve the effect of MFD on biochemical/anthropometric CM risk markers in~          healthy subjects by administering the diet under conditions allowing for weight~          reduction.~        -  To identify MFD-related changes in the gut microbiota associated with improved CM risk~          markers.~        -  To assess MFD-related modification in metabolic pathways, studied with a metabolomics~          approach, and to correlate them with conventional clinical outcomes, aiming to identify~          new markers of altered metabolic risk.~   "
108394|NCT02148640|"~     The purpose of this study is to assess the safety and efficacy of switching from Remicade to~     the biosimilar treatment Remsima in patients with rheumatoid arthritis, spondyloarthritis,~     psoriatic arthritis, ulcerative colitis, Crohn's disease and chronic plaque psoriasis~   "
108395|NCT02148627|"~     The main purpose of this study is to evaluate the safety of LY3041658 in healthy~     participants, including first generation Japanese. The study will also investigate how the~     drug is processed and affects key immune cells. Study participation will last 4 months.~      Protocol amended in January, 2016 to include first generation Japanese participants.~   "
108396|NCT02148614|"~     AIMS~      Phase 1. Verify whether the intake of LibramedR is able to induce a better endocrine and~     metabolic profile.~      Phase 2. Verify whether treatment with LibramedR for 60 days produces a better glycaemic~     profile after oral glucose load.~      SUBJECTS~      Will be recruited 80 obese children for phase 1 and 40 obese children for phase 2.~      Subjects will be randomly assigned to treatment with placebo or LibramedR with a double blind~     clinical trial.~      METHODS~      Experimental protocol phase 1~      Each child will arrive at the UOC at 8 a.m., in fasting. A blood sample will be taken. Then~     patients will be given two LibramedR tablets or placebo. After 20 minutes they will be given~     a mixed meal (equal to 15 kcal per kg of lean body mass). Blood samples will then be taken at~     30-minute intervals for the first two hours and 60 minutes for the following two hours, for~     the determination of metabolites and hormones for a total of 4 hours. The level of satiety~     will be quantified through a visual analog scale.~      Experimental protocol phase 2~      Based on the results of the OGTT performed in recruitment phase, children will be divided~     into two groups: group A, children with blood glucose 2 hours after oral load higher than the~     median and group B, children with blood glucose 2 hours after oral load below the median.~      The children of group A will be randomly assigned to LibramedR treatment or placebo for 60~     days, after which they will repeat Anthropometric measurements, bioelectrical impedance, OGTT~     and blood chemistry. They will also repeat dietary and sport anamnesis .~      During the 60 days, the children of both groups will receive the same dietary treatment~     consisting of a low-calorie and balanced diet, and recommendations to practice more sport.~      Every 15 days a research assistant will contact the families to reinforce treatment~     adherence.~      EXPECTED RESULTS~      Phase 1 LibramedR intake should cause a lower increase in postprandial blood glucose,~     insulin, triglycerides and a greater decrease in ghrelin levels compared to placebo~     treatment;~      Phase 2 The treatment with LibramedR should be associated with a decrease in blood glucose~     and insulin secretion after OGTT compared to placebo treatment.~   "
108397|NCT02148601|"~     In the recent past, a deep change in the epidemiology of C. difficile infection has occurred,~     with a rise in its frequency, severity, and mortality. Both the refractoriness of the~     infection to standard therapy and its probability of recurrence have also increased,~     representing a main clinical issue. Fecal microbiota transplantation (FMT) refers to the~     introduction of a liquid filtrate of stools from a healthy donor into the gastrointestinal~     tract of a patient for the treatment of specific diseases. FMT has shown outstanding results~     in the treatment of recurrent C. difficile infection. It can be performed through various~     routes: nasogastric or nasojejunal tube, upper endoscopy, retention enema, colonoscopy. In a~     recent systematic review of studies using FMT for the treatment of recurrent C. difficile~     infection, Cammarota et al. observed that lower gastrointestinal route (colonoscopy, enema)~     led to the achievement of higher eradication rates than upper delivery (gastroscopy,~     naso-gastric or naso-jejunal tube) (81-86% vs 84-93%, respectively). In a randomized clinical~     trial, Van Nood et al. showed the efficacy of FMT by nasojejunal tube in recurrent C.~     difficile infection. Up to now, data on FMT by lower route come out only by case series and~     case reports.~      The investigators' aim is to compare the efficacy of colonoscopic FMT and standard antibiotic~     therapy for the treatment of C. difficile infection in a randomized clinical trial~   "
108398|NCT02148588|"~     Prospective, open-label study in 10 patients with Central Post Stroke Pain (CPSP). The study~     will evaluate the effects of peripheral nerve blockade on spontaneous pain and evoked thermal~     and mechanical responses in CPSP, and assesses the associated local anesthetic~     pharmacokinetics.~   "
108399|NCT02148575|"~     The purpose of this study is to test a psycho-educational intervention, Managing Cancer Care:~     A Personal Guide (MCC), that is intended to improve patients' knowledge of palliative care~     and to facilitate its timely integration into self-management of their breast cancer. The MCC~     will be tested with patients with Stage I-IV breast cancer at baseline, one, and three months~     following enrollment. The intervention group will receive the MCC, and the attention-control~     group will receive a symptom management toolkit. Participants' family caregivers will also be~     enrolled to provide information on patients' self-management. Investigators hypothesize that~     users of MCC, as compared to attention-control participants, will demonstrate improved~     knowledge, feelings, and behaviors related to self-management of their cancer care. This~     innovative research can help to establish palliative care as a mainstay of self-management~     interventions that target serious illnesses.~   "
108400|NCT02148562|"~     In this project proposal, the investigators will investigate the genetic alterations of~     Hepatitis B Virus (HBV) strains circulating in Belgian patients who developed end stage liver~     disease. Additionally, the investigators will compare and link these data sets with three~     genetic factors involved in immune system response.~   "
108401|NCT02148549|"~     FOLFIRINOX regimen was recently presented at an international oncology meeting and represents~     a new standard regimen in the treatment of metastatic pancreatic cancer. FOLFIRINOX is one of~     the high response rate treatment regimen , the investigators considered as a promising~     treatment as neoadjuvant chemotherapy . On the other hand , incidences of grade 3 or 4~     neutropenia , febrile neutropenia and diarrhea were significantly higher in the FOLFIRINOX~     group compared with gemcitabine group. Therefore, it was decided to consider the balance of~     safety and efficacy as a preoperative chemotherapy, the investigators use the FIRINOX regimen~     by eliminating LV and bolus 5-FU, and irinotecan reduced to 150mg/m2 of 180mg/m2 from~     FOLFIRINOX regimen~   "
108403|NCT02148523|"~     To assess the effectiveness of social comparison in improving the outcome of statin adherence~     versus usual care as measured by an electronic pill bottle.~      Subjects receiving weekly reports with their adherence and information about their place in~     the distribution of their peers will have the highest statin adherence of any arm, as~     measured by electronic pill bottle.~   "
108404|NCT02148510|"~     The hypothesis of the study is that a bibloc-apnea splint has a comparable efficacy on~     respiratory measures as a monobloc-apnea splint and that the cost of treatment is the same.~     The goal is primarily to compare the Apnea-Hypopnea Index (AHI) after 6 weeks of treatment~     and the cost of treatment during one year.~      This randomized controlled parallel group multicenter study includes 316 subjects referred~     for the treatment of moderate to severe Obstructive Sleep Apnea (OSA). The subjects visit the~     clinic at 5 scheduled occasions.~   "
108405|NCT02148497|"~     The purpose of this study is to show that the multi-colored Placido Disk set-up can get~     reliable data over long time periods.~   "
108406|NCT02148484|"~     Posttraumatic stress disorder (PTSD) is the most common disorder among childhood sexual abuse~     survivors and is associated with substantial psychosocial and medical problems, but~     evidence-based treatment for PTSD in adolescents is lacking. This study aims to examine the~     efficacy and effectiveness of prolonged exposure therapy for adolescents with client-centered~     therapy.~   "
108407|NCT02148471|"~     The first aim of this study is to assess oxidative stress and nutritional status in patients~     with elevated liver enzymes who were found to have either simple steatosis (SS) or~     nonalcoholic steatohepatitis (NASH) or normal histological findings on liver biopsy by~     measuring liver lipid peroxides and tumor necrosis factor (TNF)-α, liver pathology and~     immunohistochemistry, liver function tests, liver and red blood cell membrane fatty~     composition, insulin resistance (IR) parameters, plasma lipid peroxides, plasma antioxidant~     vitamins and antioxidant power, lipid profile, subject demographics, medical history and~     medication use. The second aim is to detect differences in hepatic gene expression (messenger~     RNA, mRNA) and epigenetic regulation (micro RNA, miRNA) between patients with SS or NASH and~     healthy controls, in addition to determine in patients with non-alcoholic fatty liver disease~     (NAFLD = SS+NASH combined) whether there is an association between hepatic n-3 PUFA content~     and gene expression. The third aim is to determine the intestinal microbiome (microbial~     composition and metagenome) in patients with SS or NASH and healthy controls.~   "
108408|NCT02148458|"~     The purpose of this research study is to evaluate the effects of intermittent fasting in~     subjects that are eating a Mediterranean diet or a Western diet. This study is part of~     ongoing research in the prevention and treatment of age-related diseases at Washington~     University School of Medicine.~   "
108409|NCT02148445|"~     Long-term NRT has not been studied in patients with COPD, and smokers in the United States~     with COPD are still asked to choose between immediate quitting or continued smoking. The~     purpose of this study is to see if guided maintenance therapy (GMT), using long-term NRT,~     might prove to be a reasonable alternative to the standard approach of asking patients to~     quit immediately. The investigators believe that GMT with long-term NRT will reduce overall~     exposure to cigarette smoke, reduce harm related to smoking, and ultimately lead to greater~     quit rates.~      In this study, 398 smokers with COPD will be randomly assigned to either receive: 1)~     traditional smoking cessation (SC) or 2) long-term, guided maintenance therapy with NRT~     (GMT). The SC intervention will be based on a standard approach to smoking cessation,~     including smoking cessation counseling supplemented with combination NRT (a nicotine patch~     plus the patient's choice of gum or lozenge) if they are willing to make a quit attempt. The~     GMT intervention will consist of counseling, focused on medication adherence and smoking~     reduction, plus 52 weeks of combination NRT. After 3, 6 and 12 months of treatment, we will~     compare the two treatments based on their effects on smoking cessation, number of cigarettes~     smoked, exposure to carbon monoxide and smoking-related carcinogens, COPD symptoms, breathing~     function, and smoking-related hospitalizations or death. The investigators will also analyze~     the data in such a way that will be able to identify which patients are most likely to~     benefit from treatment. This analysis will allow patients to estimate their chances of~     success based on their own personal characteristics and which treatment they choose.~      The investigators study addresses research priorities identified in recent smoking cessation~     guidelines and builds upon the input of our Patient Advisory Panel and our Stakeholder~     Advisory Committee. This study reflects the interests expressed by smokers in prior surveys~     and addresses the limited reach and effectiveness of traditional approaches to smoking~     cessation. If our GMT approach is effective, our study could change the recommendations~     provided in clinical practice guidelines and change the way that insurance companies pay for~     smoking cessation treatment. GMT could provide an alternative for millions of smokers with~     COPD who are not currently benefiting from traditional approaches to smoking cessation~   "
108410|NCT02148432|"~     Venous thromboembolism(VTE) is the third most common cardiovascular complication among~     hospitalized patients, and can even cause death. VTE often occurs in intensive care patients~     and there had been many efforts to prevent such complication. The American College of Chest~     Physicians (ACCP) had published evidence-based clinical practice guideline for VTE~     prophylaxis.~      This study focuses on how VTE prophylaxis is being performed in both medical and surgical~     ICUs in a single University hospital, and sees the differences in such prophylactic patterns.~   "
108411|NCT02148419|"~     Between 2007-2010 the Child Protection Team (CPT) at University Children's Hospital Zurich~     was the first in Europe to follow up the development of maltreated children in a hospital~     sample . The follow-up took place 2-3 years after the child had been reported to the CPT. As~     a major result, children's health-related quality of life (HRQoL) had been impaired in~     maltreated children compared to controls (Jud, Landolt, Tatalias, Lach, & Lips, 2012).~     However, this difference only emerged for the self-assessment of HRQoL by children aged 6~     years or older .To address limitations, the CPT at University Children's Hospital Zurich and~     Children's Hospital Baden AG propose a prospective study with a baseline at the time of~     report to the CPT and a two year follow-up. This study aims at analyzing HRQoL, behavior and~     mental health of maltreated children prospectively and will be the first to provide data on~     changes in HRQoL in the aftermath of maltreatment. We assume the following hypotheses:~        -  The HRQoL and mental health of children will be impaired following maltreatment even~          while controlling for others possible predictors of impaired HRQoL and mental health.~        -  We assume a dose-response relationship between severity of maltreatment and impaired~          HRQoL. Multiple maltreatment is hypothesized to have a larger impact then a single type~          of maltreatment.~        -  At baseline, HRQoL scores are hypothesized to be at a markedly low level. We assume a~          slight increase in HRQoL from baseline to first follow-up, but not a continuing increase~          to second follow-up.~   "
108469|NCT02147665|"~     This is a pilot study on acute effects of Hookah smoking on the sympathetic neural control of~     the human cardiovascular system. Hookah smoking is known to transiently increase blood~     pressure and heart rate while decreasing heart rate variability suggesting - but not proving~     - sympathetic mediation. Here the investigators will directly measure the acute effects of~     Hookah smoking on sympathetic nerve activity with microneurography (intraneural~     microelectrodes) and quantify associated regional changes in vasomotor tone.~   "
108412|NCT02148406|"~     This randomized pilot clinical trial studies Yoga Skills Training or attention control in~     reducing fatigue and depressive symptoms during chemotherapy in patients with stage II-IV~     colorectal cancer. Yoga Skills Training consists of meditation, movement and breathing~     practices that aim to promote mindfulness and relaxation. Attention control consists of~     conversations with a caring professional with a recommendation to complete daily home~     diaries. It is not yet known whether Yoga Skills Training is better than attention control at~     reducing fatigue and depressive symptoms in patients undergoing chemotherapy.The purpose of~     this initial feasibility study is to refine study procedures.~   "
108413|NCT02148393|"~     A randomised controlled open-label clinical trial to compare the clinical pregnancy rates~     between fresh embryo transfer and elective all-embryo vitrification with thawing and transfer~     in a subsequent cycle in high-responders~   "
108414|NCT02148380|"~     The results of fastact2 show that chemotherapy plus erlotinib significantly prolonged PFS and~     OS of patients with NSCLC. However, outcome of the combination therapy are similar to those~     reported in several trials of single-agent EGFR TKIs. So which is the optimal first-line~     treatment for patients who harbored a sensitive EGFR mutation? The investigators need a~     head-to-head study to reply.~   "
108415|NCT02148367|"~     -  Traumatic brain injury (TBI) is the leading cause of death and disability in people~          under age 45 in industrialized countries. Significant numbers of US veterans from the~          wars in Iraq and Afghanistan return with TBI. However, to date, there are no specific~          neuroprotective treatment options with proven clinical efficacy.~        -  Erythropoietin (EPO) is approved by the FDA to treat anemia and has comprehensive~          preclinical data supporting its neuroprotective and neuroregenerative efficacy following~          traumatic (TBI) and a wide range of other acquired brain insults. Injury to small and~          medium-sized cerebral blood vessels is a well recognized consequence of TBI. EPO~          increases production of endothelial progenitor cells (EPCs) and promotes angiogenesis~          and neovascularization after TBI. EPO also promotes neurogenesis and improves functional~          recovery in animals after experimental stroke and TBI. Neovascularization is coupled~          with neurogenesis, and augmentation of both processes by EPO may result in lessened~          cognitive deficits. Neovascularization by EPO may prevent post-traumatic deficits in~          cerebrovascular reactivity (CVR), which can be measured noninvasively using magnetic~          resonance imaging (MRI).~        -  This proposal is for a randomized, placebo-controlled pilot clinical trial designed to~          obtain data on the effects of EPO in humans with persistent post-concussive symptoms~          after TBI. The primary objective is to evaluate effect of 4 week administration of~          recombinant erythropoietin on numbers of circulating endothelial progenitor cells in~          patients with persistent symptoms during the subacute period after TBI. This information~          will guide the design of a future definitive study.~   "
108416|NCT02148354|"~     The purpose of this study is to determine the differential effectiveness of a self applied~     treatment delivered via Internet for the prevention and treatment of depression, with or~     without support by the therapist, compared to a waiting list control group. The principal~     hypothesis is that the two intervention groups will improve significantly compared to the~     waiting list control group, and without significant differences between them. The~     investigators believe that the support of ICTs may be doing a similar function as the weekly~     support call (to offer feedback, to reinforce, to motivate the participants, etc.).~     Furthermore the investigators hypothesize that the intervention program will be a useful tool~     for a secondary and tertiary prevention of depression.~   "
108417|NCT02148341|"~     This study determines if a community of practice of clinicians and quality improvement~     specialists can be used to implement a national quality initiative known as Hospital to Home~     (H2H). This quality initative is designed to reduced readmission rates for patients with~     heart failure or heart attack by improving the transition of care upon discharge.~   "
108418|NCT02148328|"~     The purpose of this study is to examine the safety and tolerability after administration of~     trivalent and quadrivalent cell-based virosomal influenza vaccine in healthy adults.~   "
108419|NCT02148315|"~     The purpose of this study is to determine whether school gardens affect children's physical~     activity.~   "
108420|NCT02148302|"~     Epidermal grafts are believed to promote healing by two mechanisms: graft take and the~     promotion of wound healing through the delivery of growth factors and the essential elements~     of tissue repair and wound healing.28 This study is intended to establish the superior~     effectiveness of epidermal grafting and multi-layer compression over that of multi-layer~     compression alone, in the treatment of venous leg ulcers.~      Millions of Americans are afflicted with painful, open, draining sores on their lower~     extremities. These sores are referred to as venous leg ulcerations (VLUs). Under the best of~     circumstances these ulcers require weeks or months to heal. Not uncommonly wound care~     specialists see patients who have suffered for years or faced amputation of the limb as their~     only option to alleviate the pain.~      Standard of care will result in healing in 50% of venous leg ulcers in 12 weeks. However,~     roughly half of patients suffering from venous ulcers will require advanced therapy.~     Epidermal grafting has been a reconstructive option for decades; however, to date there has~     not been a reliable and reproducible system to harvest epidermis. The CelluTome® Harvesting~     System permits the harvesting of epidermal blister grafts at the patient's bedside without~     the need for anesthesia. The grafts can be easily transferred to the wound bed. In case~     studies, epidermal grafting appeared to be effective in reducing wound size and accelerating~     closure of venous leg ulcers.~   "
108421|NCT02148289|"~     The acute consumption of dietary nitrate has been shown to improve exercise capacity in~     athletes, healthy adults and subjects with peripheral vascular disease. Many COPD patients~     have reduced exercise capacity, The investigators hypothesized that acute nitrate~     consumption, in the form of beetroot juice, might increase incremental shuttle walk test~     (ISWT) distance in COPD subjects.~   "
108482|NCT02147496|"~     The purpose of this study is to examine the effects of fluid dairy products on blood glucose~     and insulin, satiety and energy intake in normal weight and overweight/obese children in the~     age range of 9-14 y. Experiment 1: The specific objective is to examine the effects of~     isocaloric and isovolumetric amounts of 2% M.F. milk, 1% M.F. chocolate milk, 1.5% M.F.~     yogurt drink, tropical punch and water consumed before and within a pizza meal 60 min later~     on appetite and food intake. Experiment 2 will compare the effects of 2% M.F. milk and~     tropical punch consumed before and with a pizza meal 60 min later on food intake, blood~     glucose, and appetite hormone response.~   "
108422|NCT02148276|"~     This two-phased project will develop a comprehensive, audio computer assisted~     self-administered interview social harm questionnaire (ACASI-SHQ) that will allow researchers~     to more easily identify and monitor social harms experienced by substance abusers~     participating in HIV-related trials. The ACASI-SHQ will (1) reduce the likelihood of socially~     desirable responding, (2) include items with high levels of specificity to increase the~     likelihood of identifying social harms (construct validity), and (3) utilize a self-interview~     format that will increase the likelihood of its adoption by HIV researchers. The~     investigators will then evaluate its feasibility, acceptability, and preliminary utility and~     construct validity in an ongoing HIV-related trial.~   "
108423|NCT02148263|"~     Eye care professionals prescribe contact lenses to new wearers on a daily basis, and it is~     common practice for practitioners to educate their patients to gradually increase their~     contact lens wear time over their first few days of use; however, there is no scientific~     basis in the literature for this practice. This study will compare the ocular health and~     comfort of new contact lens wearers who are randomly assigned to begin contact lens wear with~     increasing wearing time versus those who immediately start full-time wear (eight hours or~     more/day). The increasing wearing time group will wear daily wear contact lenses (Acuvue~     Oasys) for two, four, six, eight, and eight or more hours on the first, second, third,~     fourth, and fifth days, respectively. The other group will be instructed to wear the same~     contact lenses for eight or more hours per day, starting with the first day of wear. Both~     groups of subjects will have their eye health and comfort evaluated at baseline, one, and two~     weeks with a lighted-microscope and eye comfort surveys. Subjects will also keep a daily log~     of eye comfort with a visual analog scale survey at home. All subjects will learn how to wear~     and take care of contact lenses. They will also receive a prescription for contact lenses at~     the conclusion if they wish to continue wearing the study contact lenses.~   "
108424|NCT02148250|"~     The purpose of this study is to learn more about how U500 regular insulin can be effectively~     be used to treat type 2 diabetes. Most insulin treated patients with type 2 diabetes take~     U100 insulin, but if they require large doses (such as >150 units a day) they may experience~     pain at this site of injection and the absorption of the insulin is unpredictable, thereby~     leading to poor glucose control. To overcome these problems, doctors sometimes switch to a~     more concentrated form of insulin called U500 insulin. U500 is five times as concentrated as~     U100 insulin and therefore delivers an equivalent dose of insulin in much lesser volume.~     However, how to best use U-500 insulin is not certain. The investigators are not really sure~     how long a given dose is effective in patients who require large doses (>150 units of U100~     insulin), so are not sure of how often the drug should be administered. In this study, the~     investigators will determine how effective two different doses of U-500 regular insulin (100~     U and 200 U) are in lowering blood sugar and how long these two doses last. This information~     will help doctors develop better treatment plans for patients with type 2 diabetes.~   "
108425|NCT02148237|"~     This study is to determine preliminary effects of home-based individual breastfeeding~     consultation with and without cash incentives to increase breastfeeding (BF) duration among~     low-income Puerto Rican mothers enrolled in a Special Supplemental Nutrition Program for~     Women, Infants, and Children (WIC).~   "
108426|NCT02148224|"~     Glycemic index concept is widely used to determine impact of a food to blood glucose.~     Although the previous studies showed that glycemic index did not seem to be related with~     subject-specific factors, currently several studies found conflicting results on the~     relationship of subjects' characteristics and glycemic index values. This study aims to~     determine whether body composition parameters, as subject-specific factor, correlate with~     glycemic index values.~   "
108427|NCT02148211|"~     The purpose of this pregnancy registry study is to detect and describe abnormal pregnancy~     outcomes in women intentionally or unintentionally vaccinated with any of GlaxoSmithKline~     (GSK) Biologicals' seasonal Inactivated Influenza Vaccines (sIIVs): Fluarix, FluLaval,~     Fluarix Quadrivalent and FluLaval Quadrivalent.~   "
108428|NCT02148198|"~     Part 1 of the study will assess the effect of 1g, 2g and 5g doses of NWT-03 on systolic and~     diastolic blood pressure in a cross-over designed study in healthy adults with normal, high~     normal and mild hypertension. Based on results from this study, one dose will be selected for~     a placebo controlled parallel study assessing a single dose of NWT-03 on systolic and~     diastolic blood pressure and endothelial function in a similar population.~   "
108429|NCT02148185|"~     The purpose of this study is to evaluate PK, PD and safety of a single oral dose of MT-1303~     in subjects with Crohn's disease.~   "
108430|NCT02148172|"~     While surgical anterior cruciate ligament reconstruction (ACLR) of the knee restores passive~     stability, studies are showing consistently poor long-term outcomes. Unusually high risks of~     early-onset osteoarthritis and re-injury, and low rate of return to sport following ACLR all~     seem to be related to a chronic tendency to land stiff-legged from a jump or hop, which~     itself may be due to fear of re-injury. Decreased knee bending for force absorption~     simultaneously decreases performance level and increases risk for injury and arthritic~     changes.~      The purpose of the proposed study is to compare a current best-practice plyometric training~     program to one utilizing body weight support to increase repetition and improve performance~     in the initial phases. The investigators hypothesize that we will see larger improvements in~     absorptive capacity of the knee and better confidence in activity immediately following body~     weight support training, as well as improved retention of training effects after a two-month~     period.~   "
108431|NCT02148159|"~     Patients with cancer often experience appetite loss and weight loss unintentionally. Rapid~     weight loss negatively impact on physical functioning, quality of life, and overall survival.~     Patients will be randomly assigned into two groups. An intervention with acupuncture may slow~     down or stop the progression of cancer-related anorexia and weight loss.~   "
108432|NCT02148146|"~     This is a clinical study designed to evaluate the safety and benefit of a fish oil based fat~     emulsion in the treatment of liver disease associated with prolonged use of intravenous~     nutrition.~   "
108685|NCT02144857|"~     Psoriasis has been associated with an increasing risk for atherosclerosis. The investigators~     investigated whether surrogate markers of subclinical atherosclerosis, vascular dysfunction~     and myocardial dysfunction are impaired in patients with psoriasis compared to normal~     controls ,coronary artery disease patients and untreated hypertension subjects. The~     investigators also examined the effect of treatment with biological vs no biological agents~     on vascular and LV function in psoriasis.~   "
108433|NCT02148133|"~     This is an open-label, non-randomized, phase II study to assess the efficacy and safety of~     eltrombopag in Japanese moderate or more severe aplastic anemia (AA) subjects with a platelet~     count <30,000/ microliter who are refractory to anti-thymocyte globulin (ATG)-based~     immunosuppressive therapy (IST), who have relapsed after ATG-based IST, or who are ineligible~     for ATG-based IST.~      Eltrombopag is expected to improve trilineage blood cells and decrease transfusion frequency~     based on the result from the previous study in patients with severe AA. This study will use~     the hematologic response rate, defined as the proportion of subjects showing improvement in~     at least one of the three blood cell lineages or a decrease in blood transfusion volume, as~     the primary endpoint.~      Twenty patients will be enrolled in the study. Treatment with eltrombopag will be started at~     25 milligram (mg)/day and increased by 25 mg/day every 2 weeks according to the platelet~     count up to 100 mg/day. Response assessment will be performed at 3 months after starting the~     study treatment (Week 13). Subjects in whom the treatment is assessed as effective will be~     continued with the study treatment. Subjects in whom the treatment is assessed as effective~     (when meeting any of the response criteria) at 6 months after starting the study treatment~     (Week 26) may enter the extension phase and continue the treatment with eltrombopag. The~     primary endpoint is the hematologic response rate at Week26.~   "
108434|NCT02148120|"~     The aim of the study is to demonstrate the non-inferiority in terms of acute bronchodilator~     effect between a single dose of CHF 1535 NEXThaler 200/6 µg and a single dose of CHF 1535~     NEXThaler 100/6 µg at two dose levels in partially controlled and uncontrolled asthmatic~     patients.~   "
108435|NCT02148107|"~     It is the objective of this MRD trial to investigate pharmacokinetics, pharmcodynamics,~     safety and tolerability of rising doses BI 691751 over a treatment period of 14 days to~     support the further clinical development of this LTA4H-inhibitor. Special emphasis will be~     given to detect potential effects of BI 691751 on heart rate.~   "
108436|NCT02148094|"~     Female sex workers (FSWs) in India are at high risk of HIV infection, and while correct and~     consistent condom use is an effective means of preventing HIV transmission, many FSWs have~     difficulty insisting on their use. Alternative HIV prevention options are needed for FSWs who~     are unable to correctly and consistently use condoms with their clients or regular partners.~     Oral pre-exposure prophylaxis (PrEP) may be an important tool to fill this critical~     prevention gap, and a demonstration project is required to assess the impact and feasibility~     of the use of PrEP as an HIV prevention intervention among most at risk FSWs in India.~      The proposed project will take place at two sites in India and will assess the use of a risk~     assessment tool to identify FSWs who would most benefit from PrEP, collect information about~     the reasons why FSWs choose to accept or decline PrEP, evaluate two different PrEP delivery~     strategies (weekly clinic pick-up or home delivery by peer educators every second day),~     monitor adherence to and discontinuation of PrEP, and evaluate unintended consequences of the~     use of PrEP in these communities (e.g. reduction of condom use, drug side effects or adverse~     events, social harms or resistance). To ensure the safety of study participants, a community~     advisory board will be set up and will meet regularly to inform study staff of any concerns~     that the community may have related to the study, so that the study staff can respond in a~     timely manner. A data safety and monitoring board will also be established to monitor~     participant safety.~   "
108437|NCT02148081|"~     When children suffer from a critical-illness, the investigators focus on resuscitating and~     saving lives. Once these children leave the pediatric intensive care unit, very little is~     known about what happens to them - how long it takes for them to recover, how families cope,~     and what factors that impede their recovery. The specific objective of this research project~     is to evaluate how children and their families recover after a critical illness.~      Research Hypotheses: Following a critical illness in children, 1) the rate and degree of~     health and functional recovery is influenced by the following factors: age, pre-admission~     co-morbid status, critical illness severity, discharge functional status, and time to~     initiating acute rehabilitation; 2) functional recovery is influenced by caregiver burden and~     health-related quality-of-life (HRQoL).~   "
108438|NCT02148068|"~     Obesity is an important public health issue worldwide. In the United States, the percentage~     of overweight and obese adults increased from 47 and 15%, respectively, to 69 and 36% in the~     last 40 years. Medically supervised attempts at weight loss are fraught with failures and~     recidivism. Surgical approaches to this important issue are both durable and effective. The~     gold standard approach to the surgical treatment of obesity and the attendant medical~     comorbidities is the laparoscopic roux-en-y gastric bypass (RYGB) and the laparoscopic sleeve~     gastrectomy (LSG). The mechanisms by which these two operations work and the associated side~     effects are not completely understood. It is established that the RYGB induces changes in~     both the fatty tissue mass (FTM) and lean body mass (LBM) post-operatively. This is~     associated with decreases in bone mineral density, basal metabolic rate, and potentially the~     ability to maintain weight loss. There is only incomplete information on the influence that~     the LSG has on body composition. This study proposes an evaluation of the changes in body~     composition that occurs following these two disparate operations. Using serial measurements~     by the BodPod and collecting information on the patients' dietary intake, exercise habits and~     comorbidity resolution, this study will help to better define the influence that the LSG has~     on body composition. It is hypothesized that the addition of a malabsorptive component will~     result in increased speed weight loss and overall weight loss which will have a negative~     impact in the preservation of lean tissue mass for the patient. This information can then be~     used by bariatric surgeons to better cater the surgical procedure and post-operative plan to~     the patient's body make up and medical comorbidities.~   "
108491|NCT02147379|"~     This is a 6 week, randomized, open-label, parallel group study in patients with Bipolar-I~     disorder (manic depression), who are in remission from an episode. Participants who show~     cognitive impairment at baseline will be randomized to receive open-label Lurasidone added on~     to their current medication(s) or continue their usual treatment for 6 weeks. Participants~     will have 3 clinical visits and 2 telephone appointments during the study. Given the~     preliminary evidence for efficacy of Lurasidone in improving cognition in schizophrenia, we~     propose to examine the efficacy of Lurasidone in improving cognition in bipolar patients.~   "
112026|NCT02101112|"~     The purpose of this study is to determine whether the bioavailability of apixaban crushed~     tablets suspended in water or mixed with applesauce is similar to the bioavailability of~     apixaban whole tablets administered orally.~   "
108439|NCT02148055|"~     Fetal intra uterine death is a rare event (incidence 2/1000 births) , unexpected and~     psychologically painful for the couple and the healthcare team. In this difficult context, it~     is essential to understand the etiology of death to guide the management of subsequent~     pregnancies. Among the investigations, foetopathologic examination is essential, but the~     examination of the brain is not possible in more than half of the cases due to the cerebral~     maceration due to the incompressible delay between death and expulsion.~      The use of MRI as a diagnostic tool fetal post- mortem  virtual autopsy  performed before~     expulsion of the fetus is interesting because it would permit to obtain a macroscopic~     examination of the fetal brain, archivable, and a gain concerning the diagnosis. Thus, a~     normal MRI will exclude cerebral anatomical abnormality , stroke or bleeding . If MRI~     abnormalities are found , it will not only guide the foetopathologic review, but mainly to~     guide the etiology . On the other hand , it is a non-invasive tool and acceptability by the~     couple would be better than autopsy which is often refused by the couple in this difficult~     psychological context.~      In this study , MRI will be given in addition to conventional autopsy in the painful waiting~     time between the time of diagnosis of death and expulsion without delaying care . If this~     study is validated , MRI may be systematically proposed in this indication or alternative to~     autopsy when it will be refused by the parents.~   "
108440|NCT02148042|"~     Anorexia nervosa is a chronic mental health condition characterized by maladaptive food~     consumption (i.e., hypophagia) and distorted body image. There is substantial evidence of a~     phenotypic overlap between anorexia nervosa and anxiety disorders, as well as data suggesting~     the two share a common genetic pathway. Despite these findings, little research has examined~     fear conditioning among individuals with anorexia nervosa, and no research has examined~     whether individuals with anorexia nervosa have a propensity to overgeneralize conditioned~     fear stimuli, one of the more robust fear-conditioning markers of anxiety disorders. The~     current study assesses generalization of conditioned fear with fear-potentiated startle: the~     cross-species enhancement of the startle reflex when an organism is in a state of fear.~     Animal data, as well as an emerging literature in humans, tightly links fear-potentiated~     startle to the amygdala-based fear circuit. Thus, evidence of overgeneralized~     fear-potentiated startle in anorexia nervosa would link this eating disorder to~     hypersensitivity of the fear circuit and could inform the development of novel pharmacologic~     and psychological treatments for anorexia nervosa based on treatment models used in the~     anxiety disorders literature.~   "
108441|NCT02148029|"~     Despite standard care, 25%-50% of patients with clots in the deep veins of the arms and legs~     progress to chronic post-clot problems resulting in significant disability, loss of~     productivity, and healthcare costs. Reverse flow in the veins from an organizing clot is the~     primary cause of post-clot problems. Veins with early clot breakdown have a lower incidence~     of reverse flow. The investigators have observed that clot breakdown is enhanced by increased~     blood flow and that moderate arm and leg exercise result in increased venous blood flow.~     Hence, the investigators predict that a supervised exercise program in patients with deep~     vein clots could increase leg vein blood flow, accelerate clot breakdown, and decrease the~     risk of post clot problems. The primary hypothesis is that increased blood flow across the~     clot (induced by supervised exercise) will increase clot breakdown and decrease severity of~     post clot problems. The investigators are conducting a randomized clinical trial of standard~     therapy compared to progressive exercise training in patients with leg deep vein clots.~   "
108442|NCT02148016|"~     Corneal disease is a leading cause of blindness in the world. A shortage of corneal donor~     tissue has prevented many patients from regaining vision. Additionally, refractive error such~     as myopia is a major cause of impaired visual function worldwide. Although refractive error~     is correctable by procedures that modify the refractive power of the cornea, these procedures~     often weaken corneal integrity and have risk of complications. This study aims to evaluate~     the safety and efficacy of corneal surface epithelium repair and regeneration in the~     treatment of corneal surface diseases and refractive error using autologous limbal stem cell~     transplantation.~   "
108443|NCT02148003|"~     Chronic lower back pain (CLBP) is a significant health care issue in the United States and~     the world. CLBP contributes to decreased quality of life, decreased function and increased~     utilization of health care resources. The causes of CLBP tend to be multi‐factorial.~     Arthropathy of the lumbar facet joints is thought to be a common etiology (15‐45%).~     Radiofrequency Ablation (RFA) of the medial branch nerve of the facet joint is a~     well‐established treatment modality used to decrease facet joint pains. However, a wide range~     of temperature is being used (70‐90 degrees Celsius). In addition, the optimal temperature~     that provides the best patient outcomes with the least side effects is not well established~     in the pain management literature.~      This study will determine if lumbar facets medial branches RFA at 90 degrees Celsius provides~     more overall pain relief (i.e., percent of improvement), when compared to ablation at 80~     degrees Celsius with no additional adverse events. Furthermore, ablation of the lumbar facets~     nerve supply at 90 degrees Celsius will provide better improvement in the functionality~     level, general mood and quality of life as measured by VAS ( Visual Analog Scale) pain score,~     Pain Disability Index (PDI), McGill Pain questioner scores and Beck Inventory (BI) scores as~     those receiving the ablation at 80 degrees Celsius. Also, it is associated with less opioid~     consumption, no additional unwanted adverse events and/or complications along with less need~     to repeat RFA procedure over one year period.~   "
108444|NCT02147990|"~     The purpose of this study is to evaluate the safety and anti-tumor effect of rociletinib. The~     trial is open-ended, which means patients will continue to take rociletinib until the study~     doctor determines it is no longer beneficial for them.~   "
108492|NCT02147366|"~     -  Hypertension is one of the leading risk factors influencing morbidity and mortality.~          There is need for non-pharmacological management for the same. Music is known to reduce~          anxiety and holds promise for non-pharmacological management of hypertension owing to~          low cost, ease of administration and safety. The efficacy of music to reduce blood~          pressure (BP) has not been established. Besides inconsistent findings, earlier studies~          using music are frequently inconclusive from small sample size. The studies have not~          examined the biomarkers of hypertension.~        -  The purpose of this study was to evaluate the effect of Indian Instrumental music on~          pre-hypertensives and stage 1 hypertensives subjects. Non-pharmacological intervention~          improves the quality of life of hypertensives and music may serve as an adjunct therapy~          along with standard management of hypertensives.~   "
108445|NCT02147977|"~     Background: End Stage Renal Disease (ESRD) patients have an extremely high mortality and the~     leading cause of death is cardiovascular disease which accounts for 50% of all deaths. It is~     estimated that about one third is due to arrhythmias. Previous studies reveal a higher risk~     of various arrhythmias in dialysis patients but the prevalence is uncertain. Atrial~     fibrillation is the most common arrhythmia among patients with ESRD. The arrhythmia is often~     asymptomatic, but the risk of stroke increases dramatically and the annual mortality doubles.~     Autonomic cardiac dysfunction is often seen in patients with ESRD, and this is expressed by~     attenuated Heart Rate Variability (HRV) which is a measure of the variation in the time~     interval between heart beats. Attenuated 24 hours HRV is associated with an increased risk of~     sudden cardiac death in the general population and among patients with ESRD. N-3~     polyunsaturated fatty acids (PUFAs) in fish or fish oil supplements have been shown to~     increase HRV and reduce the risk of various ventricular and supraventricular arrhythmias in~     some but not all studies, but this effect has only been sparsely investigated in the high~     risk patients with ESRD, who has a very low intake of n-3 PUFAs.~      Objective: The purpose of this study is to investigate the effects of n-3 PUFA~     supplementation on HRV and arrhythmias in dialysis patients.~      Hypothesis: n-3 PUFA supplementation increases 24 hours HRV in dialysis patients. n-3 PUFA~     supplementation reduces the level of Supraventricular tachycardia, premature atrial complexes~     (PACs) and premature ventricular complexes (PVCs) in chronic dialysis patients.~      Design: Randomized double-blind, placebo controlled trial~      Study participants: 140 dialysis patients at Aalborg University Hospital and Vendsyssel~     Hospital, Hjørring in Denmark.~      Inclusion time: Summer 2014 to Fall 2015~      Methods: The patients are allocated to 3 months treatment with supplements of 2 g n-3 PUFAs~     or placebo (olive oil). The following data are registered at baseline and after 3 months~     treatment: Demographics and medical history, Standard ECG-12, blood pressure, blood samples,~     48 hours ambulatory ECG Holter recordings, Intake of n-3 PUFAs (assessed by questionnaires~     and blood measurements).~      Perspective: A positive result of this study might make it possible to achieve a reduction in~     arrhythmias and mortality in these high risk patients by a cheap and well tolerated~     nutritional supplement.~   "
108446|NCT02147964|"~     The purpose of this investigational drug study is to determine how much male hormone,~     testosterone, is needed to maintain sperm production in the testis.~   "
108447|NCT02147951|"~     Expanded access of Talimogene Laherparepvec for subjects with unresected, stage IIIb to IVM1c~     Melanoma.~   "
108448|NCT02147938|"~     Assessment in a real situation of the conversion conditions, the efficacy and the safety of~     the treatment with tacrolimus in renal transplant patients converted from the tacrolimus~     twice per day form (Prograf®) to the tacrolimus once per day form (Advagraf®) with follow-up~     at one year.~      Analysis of two groups of patients: patients converted from Prograf® to Advagraf® early~     (during the first 6 months post-transplantation) or late (between 6 and 12 months~     post-transplantation).~   "
108449|NCT02147925|"~     The aim of this study is to explore the effectiveness of liraglutide combined with metformin~     in non-alcoholic fatty-liver disease patients with type 2 diabetes mellitus (T2DM) compared~     to sitagliptin and insulin glargine in combination with metformin.~   "
108450|NCT02147912|"~     Background:~      Several clinical studies show high rates of anxiety and depressive disorders in Chronic~     Obstructive Pulmonary Disease (COPD), that suggest common underlying pathogenetic mechanisms~     of COPD and depressive disorders. The aim of this study is to evaluate the effects of aerobic~     exercise, proposed in the context of pulmonary rehabilitation, in a sample of COPD depressed~     patients without psychopharmacological treatment, through the correlation of some~     psychopathological variables and physical/pneumological parameters.~      Methods:~      The investigators have designed an observational longitudinal trial. The trial will be~     prospective 6-weeks randomized clinical study to evaluate the impact of aerobic exercise on~     depressive symptoms in 154 patient affected by COPD and depression, assessed by Hamilton~     Depression Rating Scale (HDRS). The investigators will also monitor anxiety, quality of life~     and neurocognitive function.~      Outcome measures:~      The investigators compare the variation of HDRS total score, as primary outcome measure, in~     two groups (A, B) of COPD depressed patients matched for: COPD status; depressive status;~     age; gender. Only the participants randomized in study group A will receive a 6-weeks aerobic~     exercise intervention.~      Statistical analysis:~      All tests are two-tailed and a p value 0.05 was considered significant. The difference~     between the two groups will be evaluated with Student's T test for normally distributed data,~     and with Mann-Whitney's U test, for those with not normal distribution. The normality of~     distribution will be evaluated with the Kolmogorov-Smirnov test. Any correlations among the~     variables under evaluation will be assessed by Spearman r correlation. Variables will be~     compared using the Chi-squared test or Fisher exact test for categorical variables.~      Discussion:~      There is a strong correlation between physical activity and mental health. Several data have~     suggested that aerobic exercise shows significant effects, comparable to pharmacotherapy and~     to psychotherapy, on reducing depressive symptomatology. The goal of our study is to propose~     an effective intervention to reduce the risk of severe depression in this special population,~     evaluating the variation of HDRS total score after the aerobic exercise intervention.~   "
108451|NCT02147899|"~     The purpose of this research study is to test the safety and effectiveness of the oral~     investigational new drug, SYM-1219, for the treatment of bacterial vaginosis.~   "
108452|NCT02147886|"~     -  This is an exploratory, randomized, parallel-group, dose escalation and dose-controlled~          study without a placebo arm.~        -  Eligible patients will be randomized in a 1:1 ratio (double-blind) to receive Cabaletta~          in 2 doses, once weekly for 22 weeks (total of 24 weeks of treatment).~   "
108453|NCT02147873|"~     This is a randomized double blind placebo controlled study of azacitidine with or without~     birinapant in subjects with higher risk Myelodysplastic syndrome, secondary MDS or~     myelomonocytic leukemia (CMMoL) who are naïve, to azacitidine therapy. Pre-clinical and~     mechanistic studies support that azacitidine may modulate pathways that enable~     birinapant-mediated anti-tumor activity.~   "
108454|NCT02147860|"~     The overall aim of this proposed research is to determine the safety, feasibility and~     efficacy of the Diabetes Assistant (DiAs) controller in day and night closed-loop control in~     children and adolescents with type 1 diabetes over multiple days in a diabetes camp setting.~     This will be addressed in two parts: 1) An in residence, outpatient study to determine safety~     and feasibility of the DiAs during 72 continuous hours of day and night glucose control; and~     2) Camp studies planned for the summer of 2014 with randomization to either full closed-loop~     or sensor-augmented pump therapy over the duration of 6-7 day diabetes camps.~   "
108455|NCT02147847|"~     Hearing in noisy environments is a perceptual problem that is ubiquitous in modern~     industrialized societies. This particular listening context offers a particular challenge to~     individuals living with hearing impairment (30 million in US alone) even after treatment with~     hearing aids or cochlear implants. The ability of the brain to extract regularities from the~     environment and suppress distracting information can be improved with intensive cognitive~     training. The investigators will test whether the hearing in noise abilities of adults living~     with hearing impairment can be improved with a cognitive training paradigm.~   "
108456|NCT02147834|"~     To determine if ranolazine improves angina symptoms at 4 months compared with placebo among~     patients who are deferred for receiving a Percutaneous Coronary Intervention (PCI) based on~     the Fractional Flow Reserve (FFR) measurement.~   "
108524|NCT02146950|"~     This study is designed to investigate whether LCS12 is associated with an increased risk of~     unintended pregnancy compared to Mirena and to copper IUDs. The objective is to assess among~     new users the risks of certain events (e.g. contraceptive failure rate, ectopic pregnancy,~     uterine perforation, and PID) associated with the use of LCS12 compared with the established~     hormonal IUD Mirena, and compared with established copper IUDs during standard clinical~     practice. In addition, drug utilization patterns will be described.~   "
108457|NCT02147821|"~     This prospective randomized controlled trial will examine the efficacy of reducing the number~     of chest tubes used in the postoperative cardiac surgery patient. Typically used are three~     chest tubes - two in the mediastinum and one in the pleural space, if opened. The~     investigators propose that removal of the pleural tube will not impact the rates of~     clinically significant pleural effusions post cardiac surgery. Patients will be randomized~     into two groups - one receiving the standard three chest tubes (standard), and the other~     receiving only mediastinal drains (experimental). The primary outcome will be rates of~     post-operative pleural effusions as determined by defined interventions, including insertion~     of a chest tube, thoracentesis, or return to the operating room for primary evacuation of~     pleural effusion or hemothorax. Secondary outcomes include length of hospital stay, length of~     mechanical ventilation, postoperative respiratory status, and presence/size of pleural~     effusions, as well as readmission for pleural effusion.~   "
108458|NCT02147808|"~     This study is designed to evaluate the effects of telotristat ethyl on the pharmacokinetics~     of midazolam in healthy male and female subjects.~   "
108459|NCT02147795|"~     -  This epidemiological trial will determine whether the implementation of a PBM program is~          safe and effective in terms of clinical outcome compared to a pre-implementation cohort~        -  Primary endpoint is a composite outcome comprising in-hospital myocardial infarction,~          stroke, acute renal failure, death of any cause, pneumonia and sepsis until discharge~          from hospital in patients before and after implementation of the PBM program.~        -  Secondary endpoints are the length of stay on the intensive care unit, total hospital~          stay and the quantitative utilization of allogeneic RBC units, platelet concentrates,~          other blood products (e.g. fresh frozen (therapeutic) plasma), coagulations factors, and~          cell saver systems during hospital stay.~        -  The primary aim is to prove non-inferiority of the intervention (PBM) group when~          compared with the control group stratified by center.~   "
108460|NCT02147782|"~     Patients with chronic renal insufficiency usually develop secondary osteoporosis or bone~     loss, which is called renal osteodystrophy. Most of the previous studies focused on bone~     metabolism of patients in late stage of chronic renal insufficiency, especially those with~     chronic dialysis. In this study, bone metabolism of patients in different stages of chronic~     renal insufficiency will be observed to reveal the mechanism of development of renal~     osteodystrophy and provide clues for early intervention on renal osteodystrophy.~   "
108461|NCT02147769|"~     Premature infants are at high risk for variations in blood pressure and oxygenation during~     the first few days of life. The immaturity of the premature brain may further predispose~     these infants to death or the development of neurologic problems. The relationship between~     unstable blood pressure and oxygen levels and brain injury has not been well elucidated.~      This study investigates the utility of near-infrared spectroscopy (NIRS), a non-invasive~     oxygen-measuring device, to identify preterm infants at highest risk for brain injury or~     death.~   "
108462|NCT02147756|"~     The purpose of this study is to compare structural changes in the skin caused by the CO2RE~     device versus the Repair.~   "
108463|NCT02147743|"~     This randomized controlled study tests an innovative juvenile diversion model that integrates~     evidence-based family therapy.Immediate and longer term effects of the family intervention~     will be compared to Services As Usual with 120 adolescents participating in Miami-Dade's~     Civil Citation Program.~   "
108464|NCT02147730|"~     Regional anesthesia techniques, with administration of local anesthetics for neuraxial or~     peripheral route are now playing a central role in modern anesthesia and in particular in the~     control of postoperative pain. There are many review and meta-analyzes suggesting that a good~     pain control, and specifically loco regional analgesia, may improve the outcome of patients~     undergoing surgery.~      The control of acute post-operative pain is not the only challenge to be paid by~     anesthesiologists, because there is still much to be understood in relation to persistent~     post-surgical pain (PPP), and about the degree of influence that regional anesthesia plays in~     complete long-term functional recovery of patients.~      From the pathophysiological perspective there is not a precise definition of the mechanisms~     and risk factors that determine the onset of the persistent pain after surgery, but, more in~     general, it seems to be related to a malfunction of the mechanism of secondary hyperalgesia.~      Regional anesthesia could play a key role, as the main determinant of chronic pain is acute~     post-operative pain. The techniques of regional anesthesia exert a powerful block at the~     peripheral level, potentially preventing the progression of central pain and the persistence~     of stimuli that can reach the central nervous system. In addition, during surgery, these~     techniques can reduce the metabolic alterations and the triggering mechanisms of local and~     systemic pro-inflammatory mediators' release.~      Few perspective studies exist about the influence of regional anesthesia on long-term outcome~     and persistent pain after surgery.~      The objective of the investigators study is to assess in a prospective fashion the role of~     regional anesthesia/analgesia technique in preventing (or not) persistence pain occurrence~     after surgical interventions which are mostly associated to pain persistence, and understand~     if regional anesthesia provides advantages in other post-surgical outcomes.~   "
108465|NCT02147717|"~     Prospective study, controlled, randomized, single-center, blinded, which aims to evaluate the~     effect of laser acupuncture in the treatment of perioperative pain during tracheal suction~     after patent ductus arteriosus ligation in preterm infants.~   "
108466|NCT02147704|"~     It has been known that the blood pressure lowering effect of angiotensin receptor antagonists~     (ARBs) and angiotensin converting enzyme (ACE) inhibitors is impaired in patients on high~     sodium intake. There was an enhanced blood pressure lowering effect of ACE inhibitor when~     sodium intake was restricted or diuretics were added.~      The reason is partially explained by sodium sensitivity or low rennin activity in high sodium~     intake. However, the exact mechanism of sodium intake dependency is not clearly understood.~      In a recent study, an ARB, candesartan was revealed to have sodium intake dependency, showing~     lower plasma concentration when subjects were on high sodium intake compared to on low sodium~     intake. However, plasma concentration of another ARB, valsartan and an ACE inhibitor ramipril~     was not changed depending on the sodium intake.~      The strongly suggested mechanism is the involvement of transporter P-glycoprotein (Pg-P). the~     function and expression of Pg-P are modified by genetic polymorphism of multidrug resistance~     1 gene.~      Although the transport mechanism of Fimasartan from gut is not fully understood, it has been~     known that the multidrug resistance 1 is not involved. Thus, the pharmacokinetic and~     pharmacodynamic property of fimasartan is expected not to be affected by the status of sodium~     intake.~      The present study is designed to investigate whether the pharmacokinetic and pharmacodynamic~     property of fimasartan is changed depending on the sodium intake.~   "
108467|NCT02147691|"~     The pilot study will investigate whether combination treatment of Finacea 15% Gel and~     Brimonidine 0.33% Gel could be more effective than Brimonidine 0.33% Gel monotherapy in~     treating both the papules/pustules and erythema associated with rosacea.~   "
108468|NCT02147678|"~     To compare the effect of propofol and etomidate in hysteroscopy on postoperative sedation and~     cognitive function in elderly patients~   "
108470|NCT02147652|"~     Symptoms of agitation include abuse or aggressive behaviour toward self or others,~     appropriate behaviour performed with inappropriate frequency, or behaviours that are~     inappropriate according to social standards. In the later stages of dementia agitation can~     contribute significantly to patient distress and caregiver stress, and has been associated~     with poor quality of life. Previous research studies have shown some evidence that~     personalized music played in daily care situations reduces agitation. The purpose of this~     study is to evaluate the effects of personalized music therapy via headphones on agitation~     during hygiene care (grooming).~      This study will involve 60 in-patients of the Geriatric Psychiatry ward of Toronto~     Rehabilitation Institute. The study would take place over the span of 2 weeks and would~     involve listening to personalized and either non-personalized or no music during daily~     hygiene care (grooming). Enrolment is completely voluntary and all personal data obtained~     will remain confidential.~   "
108471|NCT02147639|"~     This study is intended to build on a growing body of literature showing a blood flow~     abnormality in patients with Becker muscular dystrophy. The investigators' laboratory~     recently showed that this blood flow abnormality could be corrected by a single oral dose of~     the drug Tadalafil (also known as Cialis). The investigators now wish to replicate these~     exciting results using a common nitric oxide donor (sodium nitrate).~   "
108472|NCT02147626|"~     This study will compare two arms in a randomized clinical trial of cardiovascular risk~     prevention in women with a history of preeclampsia. The first arm will provide postpartum~     patients and their clinicians with the American Heart Association's (AHA) Class I Lifestyle~     Recommendations for women with a history of preeclampsia. The second arm will additionally~     receive access to a customized patient-informed online program with modules on how to achieve~     the AHA recommendations for diet, activity and weight management.~   "
108473|NCT02147613|"~     Heart failure is a major health concern and is the leading cause of hospitalization among~     elderly Americans. Currently 5.7 million Americans are estimated to have heart failure and~     the estimated direct and indirect costs of treating heart failure are approximately $37.2~     billion. Approximately 40% of those diagnosed with heart failure will have heart failure with~     preserved ejection fraction (HFPEF). These individuals have significant restrictions in their~     ability to carry out activities of daily living. Exercise training has been established as~     adjuvant therapy in heart failure. Although exercise training guidelines for treatment of~     heart failure with reduced ejection fraction (HFREF) are well established, no consensus~     exercise guidelines exist for management of HFPEF. Aerobic and cardiovascular adaptations are~     generally greater after high-intensity exercise training; interval-type exercise facilitates~     this type of training because it allows for rest periods that make it possible for patients~     with heart failure to perform short (e.g., 1-4 minutes) work periods at intensities that are~     higher than would be possible during continuous exercise. High-intensity aerobic interval~     training presents a unique, yet untested, therapeutic modality for the exercise training of~     patients with heart failure with preserved ejection fraction. Pilot testing is warranted,~     results of which may have important implications for reducing cardiovascular risk, increasing~     short- and long-term quality of life and survival, and reducing healthcare costs in this~     patient population. The investigators primary specific aim is to determine the efficacy of a~     novel, high-intensity aerobic interval exercise training program for improving VO2peak (peak~     oxygen uptake), endothelial function, and arterial stiffness in patients with HFPEF. The~     investigators secondary aim is to determine whether the vascular changes are correlated with~     the changes in VO2peak.~   "
108474|NCT02147600|"~     The main goal of this study is to determine optimal cut-off values of adalimumab trough~     levels corresponding to good clinical response. Determination of these values is necessary to~     compose a therapeutic algorithm, in which the dosing schedule can be adjusted according to~     serum trough levels of adalimumab and AAA (anti-adalimumab antibodies). A secondary objective~     of this study is to further detect and quantify AAA and to correlate them with adalimumab and~     clinical response in a real life setting cohort of psoriatic patients.~   "
108475|NCT02147587|"~     This study will evaluate immune response following administration of zoster vaccine in~     subjects with rheumatoid arthritis who are receiving background methotrexate and initiate 5~     mg twice daily of tofacitinib or placebo for tofacitinib 2 to 3 weeks following vaccination.~   "
108476|NCT02147574|"~     Purpose:~      To evaluate the curative effect of Laparoscope Sub-total Colectomy with Anti-peristaltic~     ileosigmoid anastomosis for the treatment of slow-transit constipation on the patients with~     STC.~      Methods and techniques:~      The data of patients with STC preformed surgery of laparoscopic subtotal colectomy with~     anti-peristaltic ileosigmoid anastomosis during 2009.01-2014.05 was reviewed. The related~     status such as frequency of defecation, course of constipation, laxatives use condition the~     condition of using laxatives, and changes in weight were investigated. Changes of defecation~     and weight, periprocedural complications (wound infection, lung infection and intestinal~     fistula), long-term complication (malnutrition, abdominal pain, ileus), life satisfaction,~     wexner score of pre-operation and postoperation ect were investigated in follow-ups.~   "
108477|NCT02147561|"~     This study will evaluate the safety and efficacy of BOTOX® treatment in Korean adults with~     chronic migraine.~   "
108478|NCT02147548|"~     The purpose of this study is to evaluate the effects of etifoxine (an anxiolytic) compared to~     lorazepam (a benzodiazepine anxiolytic) on vigilance and cognitive functions in the elderly.~   "
108479|NCT02147535|"~     The purpose of this study is to determine whether differences in the gene coding for the~     liver enzyme carboxylesterase 1 (CES1) means differences in the metabolism of~     methylphenidate, a CES1 dependent drug.~   "
108480|NCT02147522|"~     Study Hypotheses (Ho) and Research Questions (RQ):~        -  Ho1. AHH will significantly improve patient depression treatment acceptance/adherence~          and depression symptoms vs UC at 6 and 12 months post-baseline.~        -  Ho2. A Helping Hand (AHH) will significantly improve and sustain patient self-care~          management in Self-Efficacy for Managing Chronic Disease (SEMCD) and Quality of Life vs~          UC at 6 and 12 months post-baseline.~        -  RQ1. What is the association between depression symptoms and concurrent chronic illness~          self-care management over time by group?~        -  RQ2. Will AHH reduce hospitalizations and Emergency Room visits and improve clinic~          appointment-keeping?~        -  RQ3. Will patient care satisfaction and reported barriers to self-care management vary~          by study group?~        -  RQ4. What factors are identified via qualitative assessments of patients, promotoras,~          Department of Health Services (DHS) medical and social work providers, and DHS~          clinic/organizational leadership regarding satisfaction with, sustainable uptake of, and~          suggested modifications of the AHH promotora delivery model?~        -  RQ5. What potential technology applications would enhance promotoras delivering~          patient-centered self-care training and resource navigation, communicating and~          integrating care with DHS, and disseminating AHH?~   "
108481|NCT02147509|"~     The purpose of this study is to evaluate the therapeutic effect and safety of therapeutic~     bandage contact lenses treating dry eye caused by Sjögren's syndrome.~   "
108483|NCT02147483|"~     We propose to conduct a pilot study that will examine the utility and mechanisms of~     Mindfulness-Based Relapse Prevention in reducing alcohol consumption, relapse rates, and~     physiological arousal to stress in adults 21 years of age and older who have met DSM-IV-TR~     diagnostic criteria for alcohol dependence within the past year but have abstained from~     drinking for the last thirty days. MBRP is designed to improve one's ability to self-regulate~     emotions, thoughts and physical states, thus reducing the need to alleviate associated~     discomfort through substance use. Participants assigned to the intervention group will~     receive an 8-week training course of MBRP over a period of nine weeks; participants assigned~     to the Treatment As Usual (TAU) group will continue treatment as usual, which includes~     utilizing their own effective strategies to refrain from alcohol use. All participants will~     be assessed for pretreatment severity of psychological abuse/trauma as well as pre and~     posttreatment psychosocial functioning (e.g., alcohol consumption, symptoms of depression and~     anxiety, emotion regulation/coping). The outcome of treatment will be evaluated using a)~     Timeline Followback drinking data and b) self-report ratings of acquisition of MBRP skills~     (e.g., state/trait mindfulness, acceptance and awareness, and perceived stress) and~     depressive and anxiety symptom severity. We hypothesize that participants who receive MBRP~     training will demonstrate greater acceptance and awareness, reduced cravings, and have a~     lower likelihood of relapse than participants in the TAU group. It is also expected that MBRP~     participants will demonstrate greater improvements on psychological measures of depression,~     anxiety, emotion regulation and coping, and show less perceived stress and physiological~     arousal to stress compared to TAU participants. Finally, little is known about which types of~     individuals are most likely to benefit from MBRP. Thus, secondary analyses will help to~     clarify for whom MBRP may be most effective.~   "
108484|NCT02147470|"~     Hepatorenal syndrome (HRS) is a common cause of acute kidney injury (AKI) in cirrhotic~     patients and has a one month survival rate of 50% and a 3 month survival rate of 20%. The~     leading theory behind HRS is selective vasoconstriction of renal vasculature in the setting~     of decreased systemic vascular resistance. Patients with liver cirrhosis suffer from a large~     degree of third spacing in the form of peripheral edema and ascites. In addition treatment~     with multiple drugs, including diuretics puts these patients at higher risks of prerenal AKI~     and ischemic acute tubular necrosis (ATN). AKI occurring due to HRS, prerenal AKI and~     ischemic or nephrotoxic ATN have different pathophysiologic mechanisms and are treated~     differently with significantly different outcomes. While renal perfusion is expected to be~     reduced in HRS and prerenal AKI, it is normal or increased in ATN. Prerenal AKI has the most~     favorable prognosis among these pathologies and treatment simply consists of volume expansion~     with blood, albumin, crystalloids or colloids. In clinical practice vasoactive agents such as~     midodrine and octreotide are used to increase the tone of splanchnic vessels and to improve~     renal perfusion. These interventions would not affect renal function in cases with ATN.~     Unfortunately, the diagnostic criteria proposed by the International Club for Ascites (ICA)~     for HRS are not specific and do not always exclude patients with other forms of acute kidney~     injury. Therefore, availability of a simple diagnostic tool for measurement of renal blood~     flow (RBF) at the bedside would be of great value in management of cases with cirrhosis of~     the liver presenting with acute reduction in kidney function. However, currently, there are~     no practical and simple tools available for this purpose.~      Contrast enhanced ultrasonography (CEU) involves the intravenous injection of gas-filled~     microbubbles to enhance the ultrasound image of the organs and mainly to assess tissue~     vascularity and blood flow. We and others have used CEU to assess changes in RBF in response~     to physiologic stimuli and therapeutic interventions. Here we propose a prospective, pilot~     diagnostic study to validate the use of CEU, in assessing RBF in cirrhotic patients with AKI,~     and to assess the utility of CEU to differentiate between causes of AKI in cirrhotic~     patients.~      Our hypothesis is that CEU will show arteriolar vasoconstriction and decreased blood flow in~     the renal cortex in patients with HRS which would not change in response to volume expansion.~     On the contrary, patients with prerenal AKI will have reduced RBF which will increase after~     volume expansion. Finally, those with ATN will not have a reduced RBF at baseline.~      We plan to enroll 25 patients with liver cirrhosis and acute kidney injury who are admitted~     to the University of Virginia hospital into the study.~      CEU will be performed on all subjects to measure baseline RBF. CEU will be repeated in all~     subjects within 24 hours after volume expansion with at least 1gm/kg of albumin (up to 100~     gm/day) to assess a potential change. Hourly urine output and serum creatinine will be~     monitored for potential renal response to the volume expansion as part of clinical care. For~     the subgroup of subjects who receive treatment with combination therapy with albumin,~     midodrine, and octreotide (AMO) RBF assessment with CEU will be repeated after at least 48~     hours of receiving this combination. Renal response will be assessed by monitoring urine~     output and serum creatinine monitored as part of clinical care. All subjects will have~     measurements of fractional excretion of sodium (FENa) and urea (FEUrea) and urine microscopy~     as a part of their routine clinical care (work up of AKI). The results of these tests and the~     response to volume expansion will be used to categorize subjects into three categories of AKI~     (HRS, prerenal AKI, ATN). Correlations between RBF and its changes between different~     therapeutic interventions and renal diagnosis will be tested in this study.~   "
108485|NCT02147457|"~     Extreme preterm birth interferes with the development of the cardiovascular system. Both~     macro- as well as microvasculature undergoes extensive, organ specific maturation. Under~     normal fetal conditions, microvascular growth drives renal development and continues until~     34-36 weeks of gestational age, while retinal vascular growth continues until term age.~     Studies show that there is association between low birth weight and cardiovascular~     dysfunction. According to the Barker hypothesis, this is due to nutritional shortage. In~     extreme preterm birth cases, this growth restriction is observed in neonatal life.~      In adult life, this suboptimal growth is associated with impaired renal and (micro)vascular~     function, hypertension, glucose intolerance and cardiovascular disease. According to the~     Brenner hypothesis, disrupted renal development results in hyperfiltration and hypertension,~     a process that subsequently promotes itself and leads to renal impairment. We will~     investigate macro- and microvasculature in different organs, including eye, kidney, heart and~     sublingual mucosa in former preterm infants, now aged 8-13 years old and age-matched~     controls.~      The expectation is that the results of this project will identify risk factors for~     cardiovascular-renal disease in the adult life of former preterm infants compared to the~     controls, while further analysis on mediators in neonatal life of this cardiovascular-renal~     outcome may provide new information on perinatal risk factors.~   "
108486|NCT02147444|"~     The efficacy and safety of a novel oral Xa inhibitor for stroke and systemic embolism, namely~     rivaroxaban, in non-valvular atrial fibrillation patients are evaluated in Japanese clinical~     practice.~   "
108487|NCT02147431|"~     This trial is conducted in Europe. The aim of this trial is to investigate the effect of~     semaglutide on hypoglycaemic counter-regulation compared to placebo in subjects with type 2~     diabetes.~   "
108488|NCT02147418|"~     Cancer of the oropharynx (middle, side and back walls of the throat; back of the tongue; soft~     palate, and tonsils), or oropharyngeal squamous cell carcinoma (OPSCC), has been on the rise~     in the United States. Human papillomavirus (HPV) has been recognized in many of these~     cancers, and testing for HPV has contributed to the higher reported rates of OPSCC. In this~     study, our goal is to develop a new test that can detect certain HPV proteins in the blood or~     saliva to help improve detection of OPSCC.~   "
108489|NCT02147405|"~     Background:~      - Sometimes people with HIV, the virus that causes AIDS, can have new or worsening symptoms~     soon after starting HIV medications. Often these symptoms are caused by immune reconstitution~     inflammatory syndrome (IRIS). Researchers want to study why and how people develop IRIS and~     how best to prevent and treat it.~      Objectives:~      - To learn the causes and effects of IRIS,and how to best manage it.~      Eligibility:~      - Adults 18 and older with HIV and low CD4 counts,, about to start HIV medicines; or those~     already taking HIV medicines with symptoms thought to be related to IRIS.~      Design:~        -  Participants not on ART will have screening blood tests for CD4 count, HIV viral load~          and genetic testing.~        -  After the screening blood tests and before starting HIV medicines., participants will~          return for more than 1 visit for the following:~      <TAB><TAB>- review of medical history<TAB>~      <TAB><TAB>- physical and eye exams~      <TAB><TAB>- blood, urine, and tuberculosis (TB) tests~      <TAB><TAB>- electrocardiogram (EKG)~      <TAB><TAB>- chest x-ray~        -  apheresis: a blood drawing procedure where blood is removed from a vein, white blood~          cells are separated and collected, and the rest of the blood is returned to the person~          using another vein~        -  - PET scan - a procedure where a small amount of radioactive material is injected in a~          vein. The participant then lies on a table that slides into a scanner which takes images~          of the body.~      <TAB><TAB>- lymph node biopsy~      <TAB><TAB>- stool collection by swab~        -  After completion of the above, HIV medicines will be started.~        -  Follow-up visits will be at 2, 4, 8, and 12 weeks after starting ART, then every 12~          weeks. Some of the tests above may be repeated.~        -  Participants already on HIV medicines who may have IRIS will be screened over a 4 week~          time period to see if they really are experiencing IRIS. The screening process will~          include all of the items listed above. Follow-up visits will be at Weeks, 4, 8, 12 and~          then every 12 weeks.~        -  The study will last 1 year for both groups but may be extended to 2 years (3 additional~          appointments) for some participants.~   "
108490|NCT02147392|"~     Background:~      - A protein called translocator protein may play a role in brain inflammation. Sometimes it~     is present at higher levels in the lungs than in the brain. Researchers want to see if a drug~     called [11C]ER176 can provide an image of this protein in the brain.~      Objective:~      - To test the ability of a drug to image a protein, and test how it is distributed in the~     body.~      Eligibility:~      - Healthy adults over age 18.~      Design:~        -  Participants will be screened with medical history, physical exam, and blood and urine~          tests.~        -  Participants will have a PET scan of the brain using [11C]ER176. It will be injected~          through an intravenous tube into 1-2 arm veins. A tube may also be put into an artery at~          the wrist or elbow. Some participants will also have a lung scan.~        -  For the PET, participants will lie on a bed that slides in and out of a doughnut-shaped~          scanner. A plastic mask will be molded to their face and head. They may be wrapped with~          restraining sheets. The scan will last about 120 minutes. Blood may be taken during the~          scan.~        -  Blood and urine will be taken before and after the scan.~        -  During another visit, participants will have an MRI scan of the brain. Participants will~          lie on a table that slides in and out of a metal cylinder. A strong magnetic field and~          radio waves will take pictures of the brain. The scanner makes loud knocking noises.~          Participants will be given earplugs.~        -  Some participants will have only a whole-body PET scan using [11C]ER176.~   "
108525|NCT02146937|"~     This is an open label, single site, single arm Phase II study to evaluate the combination of~     bicalutamide plus finasteride in men with MRI detectable significant prostate nodules~     followed on active surveillance.~   "
134554|NCT01806103|"~     The purpose of the study is to determine if physician education coupled with audit and~     feedback of antibiotic prescribing can improve antibiotic prescribing by primary care~     clinicians.~   "
108493|NCT02147353|"~     External Genital Warts (EGW) are the most common sexually transmitted disease associated with~     more than 30 types of the Human Papillomavirus (HPV). Cryotherapy is an effective method of~     EGW treatment. However, multiple sessions may be required with reported clearance rates~     ranging between 27-88%. Sinecatechins 15% ointment is Food and Drug Administration approved~     for three times daily application in immunocompetent subjects 18 years and older for the~     treatment of EGW and perianal warts. Treatment of EGW with cryotherapy followed by~     sinecatechins appears to be logical. Cryotherapy has direct cytodestructive effects with~     immediate short-term efficacy on treated EGW, while sinecatechins provide field therapy,~     treating both clinical and sub-clinical lesions. For this study, the investigators used~     sinecatechins 15% ointment twice daily regimen and anticipated that the synergistic effect~     with cryotherapy will provide better efficacy that cryotherapy alone. The investigators also~     anticipated that the sequential therapy with be safe.~   "
108494|NCT02147340|"~     This study has been designed to describe the use of Remote Patient Management (RPM) systems~     equipped with sensors for the measurement of weight and blood pressure in an Italian health~     care setting, verifying their efficacy and efficiency for the remote management of heart~     failure patients with implantable defibrillators. Moreover, their ease of use and acceptance~     by physician and patient will be assessed.~   "
108495|NCT02147327|"~     Cholecalciferol (vitamin D3) is a prohormone and its active form is 1,25~     dihydroxycholecalciferol. This hormone has effect on both calcium, phosphorus and bone~     metabolism and also bone morrow, muscle, heart and immune system. For a long time, maternal~     low vitamin D level is a well known problem for our country and the level was reported as <10~     ng/ml for 46-80% of mothers.The most prominent risk factor was determined as low~     socioeconomic status. Therefore, the level of 25-hydroxy-vitamin D is supposed to be in~     relation with several neonatal morbidities and maternal complications of pregnancy.~   "
108496|NCT02147314|"~     This evaluation will evaluate a new system from YOFiMeter, known as YOFiLife Blood Glucose~     Monitoring System with YOFiMeter glucometer. YOFiLife includes a web- based data system known~     as the Web Portal and smart phone apps for the iPhone and Android. The new YOFiMeter is~     similar to other glucometers with the exception of built in test cassettes, lancet cassettes~     with enhanced communications and data reviewing options.~      This evaluation will also collect data from a YSI 2300 Stat Plus Glucose Analyzer reference~     glucometer. The YSI 2300 Stat Plus Glucose Analyzer will be used as the gold standard with~     all results compared to the YSI results.~   "
108497|NCT02147301|"~     TACE is frequently offered to patients with baseline hepatic dysfunction with the purpose of~     diminishing hepatic tumor burden while patients await transplantation. Without this~     therapeutic measure, disease may progress beyond UNOS T2 criteria required for organ~     allocation.~      The purpose of the study is to determine whether transarterial chemoembolization using~     doxorubicin-eluting beads (DEB-TACE) can be used safely and effectively to treat patients~     with liver-only hepatocellular carcinoma (HCC) and baseline hepatic dysfunction.~   "
108498|NCT02147288|"~     The specific aim of this study is to improve post-operative wound care in the morbidly-obese~     body-contouring patient population following massive weight loss undergoing either~     panniculectomy or formal abdominoplasty, those patients undergoing complex abdominal wall~     reconstruction (i.e. ventral hernia repair) and breast reconstruction with acellular dermal~     matrix, as well as patients undergoing regular lipo-abdominoplasty by comparing the~     effectiveness of standard closed-suction drains versus the immediate application of~     continuous negative pressure via a NPWT (negative pressure wound therapy) device attached to~     non-compressible drains. Additionally, we aim to demonstrate increases both in~     cost-effectiveness and quality of life in these patients with the use of the NPWT wound care~     apparatus.~      Hypothesis 1 Continuous negative pressure devices decrease the incidence of wound~     complications in comparison with conventional closed suction drains when used in patients~     after massive weight loss undergoing body-contouring procedures (panniculectomies alone and~     formal abdominoplasties), and in patients undergoing VHR and breast reconstruction with~     acellular dermal matrix, as well as those undergoing regular lipo-abdominoplasty.~      Hypothesis 2 Although initially more costly than traditional closed suction drains, the use~     of continuous negative pressure devices will in the long-term result in lower total health~     care costs in the above-stated patient population due to a decreased need for additional~     procedures and/or clinical management, including surgical interventions, hospital admissions,~     administration of antibiotics, multiple follow-up office visits, and chronic wound care.~      Hypothesis 3 Better quality of life is associated with the use of continuous negative~     pressure devices compared to closed suction drains in these patient populations.~   "
108499|NCT02147275|"~     The purpose of this study is to determine whether there is a significant decrease in cerebral~     oxygen saturation in hypertensive patients undergoing major abdominal surgery and their~     correlation with standard monitoring parameters.~   "
108500|NCT02147262|"~     The main objective of this study is to characterize the inflammatory proteins, gene~     polymorphisms, and transcriptome profiles in patients with chronic atrophic dermatitis to~     gain better insight into pathogenesis of chronic infection with Borrelia burgdorferi sensu~     lato.~   "
108501|NCT02147249|"~     The main objective of this study is to characterize the inflammatory proteins, gene~     polymorphisms, and transcriptome profiles in patients with erythema migrans to gain better~     insight into pathogenesis of early Lyme borreliosis and to define new immune modulators that~     could serve as biomarkers of disease activity.~   "
108502|NCT02147236|"~     To evaluate whether a structured social skills program, called Social Skills Development,is~     superior to a wait list control group on measures of interpersonal interaction. The Social~     Skills Development (SSD) is a 16-week, group intervention that uses activities and peer~     tutors to promote interpersonal skills in children 8 to 11 years of age with Autism Spectrum~     Disorders.Following a diagnostic and social skills assessment,children are randomly assigned~     to SSD or wait list for 16 weeks. Children who were randomized to the wait list are offered~     SSD at Week 16. Children randomized to SSD are followed for 9 months to assess the durability~     of gains during the first 16 weeks.~   "
108503|NCT02147223|"~     Epidemiological studies suggest that certain foods rich in flavanols, including cocoa~     products, red wine, and tea, are associated with decreased cardiovascular mortality and~     morbidity. Dietary interventional studies have corroborated this finding and showed that~     flavanols can acutely and after sustained ingestion improve surrogate markers of~     cardiovascular risk including endothelial function. Endothelial dysfunction is the key event~     in the development and progression of cardiovascular disease. The aim of the study is to~     assess sex specific effects of cocoa flavanols on endothelial and vascular function in~     healthy subjects.~   "
108504|NCT02147210|"~     The principal purpose is the study of the regulation of the expression of ephrin-B1 by~     immunofluorescence in kidney biopsies of patients with Chronic transplant glomerulopathy~     (CTG) compared to biopsies prior to the CTG, in same patients. Level of fluorescence in CTG~     biopsy will be the experimental reference value.~   "
108505|NCT02147197|"~     This study will evaluate the superiority of ulipristal acetate vs. placebo for the treatment~     of bleeding associated with uterine fibroids~   "
108506|NCT02147184|"~     Building on findings from animal studies, pediatric clinical trials, epidemiologic research~     in adults, and on preliminary findings from the investigators' laboratory in children and~     adolescents, this project aims to investigate whether selective serotonin reuptake inhibitors~     (SSRIs), a group of widely-used psychotropics, are associated with impaired bone~     mineralization in youths. Establishing such an association is a first step in a process that~     would eventually involve developing preventative interventions. Identifying genetic factors~     that place certain youths at higher risks for this side effect would ultimately allow~     clinicians to tailor treatment to the needs and vulnerabilities of each youth, moving the~     field closer towards individualized medicine.~   "
108507|NCT02147171|"~     Normal ageing affects vision as a result of preretinal and retinal changes. Photoreceptors,~     the light sensitive cells in the retina, degenerate and the rods (responsible for night~     vision) are most susceptible to damage with increasing age. Rod loss leads to poor vision in~     the dark which increases the risk of accidents amongst the elderly. Macular pigment (located~     in the photoreceptors)is thought to protect the retina and reduce the risk of age related~     changes. Dark adaptation, mediated by the rods, slows down with age, and is also reduced in~     AMD (age-related macular degeneration). Recent evidence suggests that lutein (the main~     component of macular pigment) supplementation improves the dark adaptation deficit in AMD~     subjects. Research into the effects of lutein in a normal human has not been previously~     conducted. Since the older population is increasing, our aim is to firstly establish the~     extent of night vision loss (using dark adaptometry) and secondly to examine the possibility~     of slowing down or reversing this loss through lutein supplementation.~   "
108508|NCT02147158|"~     This study will evaluate the superiority of ulipristal acetate vs. placebo for the treatment~     of bleeding associated with uterine fibroids~   "
108509|NCT02147145|"~     Specific Aim 1: To determine patient compliance with a GIST surveillance program Hypothesis:~     Patient compliance with a GIST surveillance program will be low.~      Specific Aim 2: To determine if EUS features of GIST, particularly maximum size, change~     significantly during a surveillance program.~      Hypothesis: EUS features of GIST, particularly maximum size, will not change significantly~     during a surveillance program.~      Specific Aim 3: To determine if EGD measures of GIST size correlate well with EUS measures of~     GIST size.~      Hypothesis: EGD measures of GIST size will correlate well with EUS measured of GIST size.~   "
108510|NCT02147132|"~     Smoking prevalence is over 83% in methadone-maintained patients. These patients experience~     significant difficulty quitting, and there is evidence that a majority of~     methadone-maintained patients smoke most of their cigarettes in the 4 hours following~     methadone dosing. The objective is to provide a preliminary test of the ability of two~     pharmacological treatments, the nicotine nasal spray and varenicline, relative to placebos,~     to reduce smoking during the 4 hours following methadone dosing.~   "
108511|NCT02147119|"~     The investigators will study Radial artery injury and endothelial function following~     trans-radial cardiac catheterisation. Radial artery injury will be quantified pre- and post-~     angiography using Optical Coherence Tomography. The participants will also have radial~     endothelial function assessed using flow-mediated dilatation at baseline, 24 hours, one week,~     one month and three months post- angiography. Blood will be taken pre and 24 hours post~     angiography for characterisation of endothelial progenitor cell numbers and function. The~     hypothesis is that trans-radial catheterisation will cause a reduction in flow-mediated~     dilatation which peaks at 24 hours and recovers at three months. The investigators hope to~     correlate the rate of this recovery with peri-procedural progenitor cell numbers.~   "
108512|NCT02147106|"~     Rationale: Patients with neuroendocrine tumors (NET) have a rare disease. Due to treating~     patients with a neuroendocrine tumor in 'NET knowledge centers' patients often have to travel~     long distances for follow-up visits at the outpatient clinic. Patients whose medical~     condition allows videoconsultation could save time by replacing outpatient clinic visits~     through videoconsultation for receiving follow-up care. Therefore, in this study we aim to~     introduce videoconsultation as a alternative for follow-up outpatient clinic visits in NET~     patients.~      Objective: The primary objective is to assess if use of videoconsultation in follow-up care~     for NET patients is feasible. We hypothesize that videoconsultation is a suitable medium for~     providing follow-up care in NET patients. Secondary objectives are to explore the amount of~     time videoconsultation takes in comparison with outpatient clinic visits and the~     acceptability and satisfaction of physicians and patients with using videoconsultation in~     follow-up care.~      Study design: The present study is a single-centre prospective feasibility study.~      Study population: Adult NET patients under surveillance or treatment of the department~     Medical Oncology at the University Medical Centre Groningen (UMCG) whose medical condition~     allows videoconsultation will be invited to participate.~      Intervention: Patient who give informed consent will participate in the study. Participants~     will receive follow-up care through videoconsultation instead of conventional visits at the~     outpatient clinic.~      Main study parameters/endpoints: The main endpoint is the feasibility of videoconsultation~     for follow-up care in NET patients. We hypothesize that videoconsultation is a suitable~     medium for providing follow-up care.~   "
108513|NCT02147093|"~     A comparative evaluation of a newly marketed multifocal contact lens with a single vision~     contact lens when used with near vision spectacles. The evaluation was to quantify the~     difference between the two test corrections.~   "
108514|NCT02147080|"~     Skin cancer is the most common cancer in the US, with over a million new cases diagnosed~     yearly. Young adults are increasingly at risk of melanoma. Contributing to the increasing~     skin cancer risk is the fact that US adolescents have the lowest skin protection rates of all~     age groups and also demonstrate increased exposure to natural and artificial UV radiation.~     Innovative interventions are needed to have an impact on skin cancer risk among young people.~     Unlike previous interventions, our skin cancer risk reduction intervention will be tailored~     (or personalized) to each individual participant and delivered via the Internet. The~     intervention will emphasize appearance concerns, which are known to be the primary motivation~     for UV exposure and lack of skin protection among young adults. This will be accomplished in~     part through the use of personalized facial images showing UV damage as well as computerized~     age progression demonstrations.~      Primary Aim 1. To examine the efficacy of a tailored intervention delivered via the Internet~     designed to increase skin protection and decrease sun exposure behavior among young adults at~     moderate to high risk of developing skin cancer. Participants will be randomized to the~     tailored intervention, the Skin Cancer Foundation website, or an assessment only condition.~      Aim 2. To evaluate whether sociodemographic variables (sex, race/ethnicity, skin type, family~     history of skin cancer), appearance consciousness, and past exposure and protective behaviors~     moderate intervention effects.~      Aim 3. To evaluate whether Integrative Model constructs (UV-related knowledge, risk~     perception, beliefs, norms, self-efficacy, and intentions) mediate intervention effects.~      The goals of future research would be to enhance the tailored intervention, for example, by~     adding additional contacts or Internet technologies or features, disseminate the~     intervention, assess the longevity of effects, and/or adapt the tailored intervention for use~     with other cancer risk behaviors or at risk groups.~   "
108515|NCT02147067|"~     The purpose of this study is to look at the effects of the drug Ranolazine compared to~     Placebo on symptoms of chest pain or chest tightness (known as angina), exercise endurance~     and ability, and changes in blood flow to the very small arteries of the heart (known as~     coronary microvascular function) in patients who do not have significant blockages in their~     major heart arteries. Ranolazine is a drug that is already approved by the FDA for angina,~     but it may be particularly effective in people with disease in their tiny heart vessels~     (known as coronary microvascular disease).~      This trial aims to enroll 50 patients with angina who undergo baseline bicycle exercise~     testing with monitoring of the heart's electrical activity and oxygen consumption (known as~     cardiopulmonary exercise test) and coronary angiogram (taking pictures of the heart arteries~     through small hollow tubes placed through the wrist or groin). If severe blockages in the~     main arteries are not found then testing for coronary microvascular function will be~     performed. Subsequently, participants will then be randomized 50/50 to either Ranolazine or~     Placebo. After taking the study drug for 12 weeks, they will then repeat the cardiopulmonary~     exercise test and the coronary angiogram with testing for microvascular function.~   "
108516|NCT02147054|"~     Organophosphate pesticide poisoning causes close to 300 000 deaths per year worldwide. Many~     patients who ingest organophosphates require ventilation; of these patients approximately 50%~     die. Much of the mortality in these ventilated patients is secondary to intermediate~     syndrome. This is because OP pesticides inhibit acetylcholinesterase, causing an excess of~     acetylcholine at nerve synapses and the neuromuscular junction (NMJ). At the NMJ, the excess~     acetylcholine causes overstimulation and damage, which may lead to sudden respiratory arrest~     or prolonged ventilation and its associated complications.~      The investigators believe that blocking these receptors using a neuromuscular blocking agent~     such as Rocuronium will protect the NMJ from damage and thus prevent intermediate syndrome~     and reduce number of intubated days and mortality.~      In this pilot randomised controlled trial Rocuronium, a competitive nicotinic receptor~     antagonist, will be used to bind to the receptor at the neuromuscular junction and to block~     the effects of the accumulated acetylcholine. The effects of OP pesticide on cholinesterase~     in the blood will then be monitored and Rocuronium withdrawn using Sugammadex as the OP is~     eliminated from the body.~   "
108517|NCT02147041|"~     The aim of this study is to examine the therapeutic effect of green tea extract on obese~     women and the correlation analysis between traditional Chinese medicine syndrome and obese~     related hormone peptides.~   "
108518|NCT02147028|"~     The purpose of this study is to evaluate whether sparing the hippocampi during whole brain~     radiotherapy following neurosurgery or stereotactic radiosurgery in patients with brain~     metastases from a systemic tumour helps preserve brain function.~   "
108519|NCT02147015|"~     The hypothesis is that in acute exacerbated Chronic Obstructive Pulmonary Disease (AECOPD),~     personalized variable dose glucocorticoid treatment will result in superior clinical outcome~     when compared to fixed or experiential dose therapy.~   "
108520|NCT02147002|"~     The National Register of Nephrology in 2007 shows, similarly to the European data, a problem~     of a high mortality rate among Polish dialysis patients.~      The main reason of death among chronically dialysis patients are cardio - vascular system~     diseases. According to The Report on the Condition of Renal Replacement Therapy in Poland in~     2007, these diseases are the cause of 53% deaths in Poland. The patients with chronic kidney~     disease (PChN) are particularly at risk of cardio - vascular complications. These~     complications occur on average 30 times more often than in the whole population, and among~     young dialysis people, these complications occur 300 times more often. In the development of~     cardio - vascular complications polyunsaturated Omega-3 acids (especially eicosapentaenoic~     acid - EPA and docosahexaenoic acid - DHA) take a special position. The reaction of~     polyunsaturated Omega-3 acids on the cardiovascular system results from the enrichment of~     phospholipids of cell membranes within EPA and DHA. It should be noted that their impact is~     dependent on the type of acid and on the dose. Docosahexaenoic acid reacts with lipids and~     lipoproteins, blood pressure, heart rate, amount of glucose, and eicosapentaenoic acid is~     responsible for antiplatelet effect.~      This project is aiming at defining and elaborating on the connection between Omega-3 acids,~     and cardiovascular complications, their influence on the functioning of the cardiovascular~     system, and moreover, a better understanding of the effects of therapeutic and~     pharmacological therapies in patients at different stages of chronic kidney disease. Carrying~     out this project will be a good start to shape an international project in this area.~   "
108521|NCT02146989|"~     Rationale:~      Children with Cerebral Palsy (CP) experience limitations in motor activities and~     participation in the community, predominantly caused by impairments in muscle function. Aside~     from abnormal posturing due to spasticity, muscle weakness can significantly contribute to~     impaired muscle function and there is increasing evidence that muscle weakness significantly~     impairs upper limb motor function and ability to perform manual tasks in children with CP.~     Studies in the last decade have shown that muscle weakness, not spasticity, is the greatest~     limiting factor of motor function in children with CP. Furthermore, there is increasing~     evidence that the strength in the upper extremities of children with CP is less compared to~     their typically developing peers (TDP). A systematic review focused on the psychometric~     properties of strength measurement instruments has shown that the number of studies~     investigating psychometric properties of strength measurement instruments is limited and that~     the methodological quality of these studies is low.~      Aim:~      The present study aims to investigate the reproducibility of the following three isometric~     strength measurements in the upper extremity of children and adolescents with unilateral CP~     as well as in TDP: Hand Held Dynamometry (HHD), pinch and grip strength using the E-link~     system and functional strength. To study to which extent upper extremity strength, both in~     the affected side and the non-affected side, differs from the strength in the upper~     extremities of TDP, these measurements will also be performed by children without~     neurological problems.~      Study Design:~      A cross-sectional study in which the reproducibility of three strength measurement~     instruments, i.e. HHD, E-link and Functional strength, will be investigated in children and~     adolescents with unilateral CP and TDP.~      Population:~      Children with unilateral spastic CP (with perinatal acquired hypoxic ischemic incidents),~     aged 7 to 18 years, Manual Ability Classification System (MACS) levels I-III, who are~     mentally able to perform the measurements will be included and TDP.~      Outcome measures:~      The most important psychometric property in strength measurement instruments is~     reproducibility. Reproducibility will be investigated using the following factors: Intraclass~     Correlation Coefficient (ICC), Limits of Agreement (LOA), Standard Error of Measurement (SEM)~     and the Smallest Detectable Difference (SDD). Reference values will be determined using the~     Generalised Additive Models for Location, Scale, and Shape (GAMLSS) method.~   "
108522|NCT02146976|"~     The investigators designed a study to determine whether Propofol or Sevoflurane would provide~     same postoperative sleep quality in patients undergoing thyroidectomy.~   "
108523|NCT02146963|"~     This study is complementary to the main study Brain Derived Neurotrophic Factor Serum Levels~     Evolution During the Six Months After Alcohol Withdrawal  NCT01491347.~      The purpose of this study is to evaluate the Bdnf gene - Val66Met polymorphism in subjects~     with alcohol dependence according to their alcohol consumption status 6 months after~     withdrawal (relapse or abstinence), in relation to the presence of psychiatric~     co-morbidities.~   "
108527|NCT02146911|"~     Clinically proven medications such as nicotine replacement therapy, bupropion and varenicline~     are available to help smokers quit but there are not widely used. The primary objective of~     this study is to evaluate the real-world long-term effectiveness of of bupropion and~     varenicline treatment in a community sample of smokers interested in quitting. The~     investigators hypothesize that varenicline treatment will result in higher quit rates at end~     of treatment and at one year after treatment compared to bupropion. Smoking status will be~     biochemically confirmed at various time points using salivary cotinine measures. Furthermore,~     since 50% of the variation in quit success is genetically determined, and the effectiveness~     of different cessation medication may differ considerably in sub-groups of smokers carrying~     certain genetic variants, the investigators will collect saliva samples from consenting~     participants to evaluate the moderating effect of genetics on treatment response.~   "
108528|NCT02146898|"~     The investigators intend to study the impact of patient positioning on the changes in blood~     pressure after spinal anesthesia for cesarean delivery. The investigators hypothesized that~     the changes in blood pressure relate to the speed with which the spinal medication rises. By~     slowing the rise of spinal anesthesia, the investigators believe that the incidence and~     severity of hypotension might be reduced.~   "
108529|NCT02146885|"~     The first step in any clinical intervention against obesity involves sustained lifestyle~     changes. Researcher can use these strategies to beneficial the effects of weight and on~     cardiovascular risk. The researcher develope methods for assessing the effectiveness use~     optical technology to make such assessments, specifically in the area of fatty tissue can~     predict the effectiveness of the intervention in causing weight reduction and treating~     metabolic disease.~   "
108530|NCT02146872|"~     Since finishing the sequencing of the human genome in 2003, genetic research in coronary~     artery disease (CAD) and other complex traits have developed dramatically. Recent genome-wide~     association studies have identified a considerable number of common genetic variants each~     associated with the disease. This has led to a new understanding but also to the discovery of~     new therapeutical targets. However, each of the variants discovered only have minor effects~     on disease development and even the pooling of the variants only explains a minor percentage~     of the total heritability. It has been evident that rare or private mutations probably play a~     great role in the genetic architecture of CAD, especially among young and severely affected~     patients. These may only be identified by sequencing. Therefore, the investigators~     hypothesize, that the use of exome sequencing (the read-off of the entire protein-coding~     regions of the genome) and linkage analysis in families of extreme phenotype cases, will~     identify disease-causing genetic variants. From the West Denmark Heart Registry the~     investigators will enroll a minimum of 120 patients with atherosclerosis who have undergone a~     coronary artery revascularization procedure before the age of 40, to participate in study~     part 1. A pedigree analysis will be performed and cardiovascular (CVD) risk factors and~     current preventive treatment will be evaluated. 1. degree relatives aged 30-65 years, who are~     free of CAD, are invited to participate in study 2. CVD risk factors are evaluated as well as~     a CT coronary angiogram is performed to quantify the degree of asymptomatic coronary~     atherosclerosis. Families from study 1 and 2, who are considered severely affected by~     atherosclerosis, evaluated on a basis of family size, number of affected and severity of~     disease, will be selected for exome sequencing. Other relevant family members will be~     included as well as their CVD risk factors will be evaluated. Exome sequencing will be~     performed and variants found will be filtered on a basis of frequency, linkage analysis, gene~     position, existing knowledge and in-silico prediction tools. Possible findings will be~     validated by Sanger-sequencing and causality of new variants will subsequently be sought to~     be proven by relevant experimental studies.~   "
108531|NCT02146859|"~     Background When general anesthesia was performed, neuromuscular blocking agents (NMBAs) are~     frequently used for facilitate tracheal intubation and keep patient still and relax during~     surgery. Unfortunately, residual neuromuscular blockade are important complication.~      There are many factors that affect neuromuscular blockade and may prolong effect of NMBAs~     which we already know about that such as body temperature, drugs, some kind of diseases.~     However there are no recent studies that mention about other factors. The purpose of this~     study is to find out other factors that affect NMBAs effect to improve patient safety.~      Methods The study is a prospective, non-randomized, blinded, observational study.~      222 patients will be included in this study and will be performed general anesthesia.~     Anesthetic technique and agent which are used depend on regular staff. Information of patient~     will be collected are age, sex, weight, height, ASA classification, anesthetic technique,~     anesthetic and surgical time, amount of inhalation agent, amount of NMBAs, amount of opioids~     and reversal agents.~      After anesthesia finish, patient will be brought to recovery room and Train Of Four watch®~     will be placed and record Train Of Four ratio by this research staff. Train Of Four ratio <~     0.9 will be defined as there is residual neuromuscular blockade in this patient.~      All patients will be divided into 2 groups: residual blockade group(patient who have train of~     four <0.9 after surgery) and no residual blockade group(patient who have train of four >0.9).~     All factor of each group will be compared between. Statistical will be analyzed to find~     significant factor which affect neuromuscular blockade.~   "
108532|NCT02146846|"~     The purpose of this study is to determine population Pharmacokinetics and differences and~     variation of pharmacokinetics parameters of Imatinib as a tyrosine kinase inhibitor in~     treatment of chronic myeloid leukemia patients in Iranian population.~   "
108533|NCT02146833|"~     This is an open-label, Phase 2 clinical study of the oral Selective Inhibitor of Nuclear~     Export (SINE) Selinexor (KPT-330) in patients with metastatic castration-resistant prostate~     cancer (mCRPC).~   "
108534|NCT02146820|"~     The purpose of this study is to determine whether Pico laser is effective and safe in the~     treatment of benign pigmented lesions.~   "
108535|NCT02146807|"~     The purpose of this study is to determine whether Pico laser is effective and safe in the~     treatment of unwanted tattoos.~   "
108536|NCT02146794|"~     Renal denervation can be carried out for heart failure~   "
108537|NCT02146781|"~     This is a research study of a vaccine for allergy to Japanese Red Cedar. The vaccine is~     called CryJ2-DNA-LAMP Plasmid vaccine. This research study will determine how the vaccine is~     tolerated and how research participants respond to the vaccine using a different route of~     administration, the Intradermal (ID) route. CryJ2-DNA-LAMP Plasmid vaccine is~     investigational, which means it is not approved for use by the United States Food and Drug~     Administration (FDA) but is available in research studies like this one.~      The study is a Phase IC study to assess and evaluate the safety and immunological responses~     to therapeutic doses of a dosing regimen of 1.08 mg and 2.16 mg of CryJ2-DNA-LAMP plasmid~     vaccine delivered intradermally (ID) using the Biojector 2000 device, to be administered~     every 14 days in subjects with atopic sensitivity to Japanese Red Cedar pollen, identified by~     skin test reactivity to this pollen. The protocol has three subject cohorts: a Cohort 1:~     composed of atopic and non-atopic subjects (half atopic and half non-atopic), who will only~     receive saline control administered using the Biojector 2000 device; a Cohort 2: atopic~     subjects, who will receive 2.16 mg per dose in a four (4) dose regimen using a Biojector 2000~     device; and a Cohort 3: atopic subjects, who will receive 1.08 mg per dose in a four (4) dose~     regimen vaccinated using a Biojector 2000 device.The study will be conducted at 1 study~     center. Subjects are enrolled in the trial for a period of 132 days. The objectives of the~     statistical analyses are to establish the safety and to explore the immunogenicity of the~     LAMP-vax vaccine using a different route of administration, the Intradermal (ID) route. All~     statistical analyses conducted on the data from this trial will be exploratory in nature.~      The primary objective of this Phase IC Study is to evaluate the safety and immunological~     responses of therapeutic doses and the dosing regimen of CryJ2-DNA-LAMP plasmid vaccine~     delivered intradermally (ID) using the Biojector 2000 device.~   "
108539|NCT02146755|"~     Aortic stenosis is a common valvular heart disease, affecting mainly people over age 60. It~     is characterized by years to decades of slow progression followed by rapid clinical~     deterioration and a high death rate once symptoms develop. The onset of symptoms confers a~     poor prognosis: patients die within an average of five years after the onset of angina, three~     years after the onset of syncope, and two years after the onset of heart failure symptoms.~     The overall mortality rate is 75% at three years without surgery. Drug therapy for it remains~     ineffective, and aortic valve replacement is the only recommended long-term treatment.~   "
108540|NCT02146742|"~     Three groups of 8 Japanese males are given single ascending doses of ASP1707 or placebo to~     assess the safety and tolerability, and to evaluate how it is absorbed, metabolized and~     distributed through the body.~   "
108541|NCT02146729|"~     In patients presenting with Type A and Type B1, B2 thoracolumbar fractures, there is a lack~     of evidence demonstrating similar outcomes between patients treated with percutaneous pedicle~     screws and those treated openly. It has been demonstrated that percutaneous pedicle screw~     fixation has fared well for patients in the short term; however, it is unclear whether the~     outcomes are equivalent or inferior/superior compared to open treatment.~      The authors seek to establish a high-level evidence base to determine clinical patient~     outcomes, radiographic outcomes, as well as cost-effectiveness data in comparing~     thoracolumbar burst fracture patients treated with percutaneous pedicle screws, open~     treatment, and brace treatment. Additionally, the authors seek to establish data relating to~     patient occupational data, complications, and need for further surgery (revision/removal of~     hardware), as well as short-term variables relating to hospital visit (length of stay,~     estimated blood loss, time under fluoroscopy).~   "
108542|NCT02146716|"~     The purpose of RESC study is to assess the efficacy of Energetic Resonance by Cutaneous~     Stimulation on alcohol withdrawal symptoms measured by CUSHMAN score and in a second time to~     measure the benzodiazepine amount prescribed during the withdrawal time.~   "
108543|NCT02146703|"~     This study will conduct a phase II study of gemcitabine and S-1 as first-line chemotherapy in~     patient with advanced biliary tract cancer~   "
108544|NCT02146690|"~     The aim of the present 3 armed placebo control parallel group randomized control trial is to~     explore the extent to which osteopathic manipulative treatment is effective in reducing pain~     in a population of complicated newborns.~   "
108545|NCT02146677|"~     Osteopathic manipulative treatment (OMT) has been used to treat term and preterm newborns.~     Recent studies demonstrated the effectiveness of OMT in reducing length of stay and costs~     (Cerritelli, 2013) as well as the likelihood of gastrointestinal episodes (Pizzolorusso~     2011). Moreover it was reported the absence of adverse events and side effects considering~     the approach safe (Cerritelli 2013, 2014).~      OMT was extensively used to treat, prevent and manage pain symptoms. Numerous research was~     published addressing acute and chronic pain in different medical conditions. However, no~     trials were carried out on pain in newborns. The aim of the present clinical trial is to~     explore the effectiveness of OMT in reducing pain in a sample of preterm infants.~   "
108546|NCT02146664|"~     This is a prospective, randomized, double-blind, double-dummy, and controlled study of~     DLBS1033 in the management of acute non-ST elevation myocardial infarction (NSTEMI) without~     early coronary revascularization. It is hypothesized that the combination of DLBS1033 with~     aspirin and clopidogrel will result in greater reduction of infarct size in comparison with~     that of aspirin and clopidogrel alone.~   "
108547|NCT02146651|"~     The addition of BioChaperone to insulin lispro may accelerate the onset and shorten the~     duration of action of insulin lispro due to facilitation of the absorption of the insulin~     after subcutaneous injection.~      The aim of the trial is to investigate the dose-response and the dose-exposure relationships~     of BioChaperone insulin lispro under 3 doses, to compare the pharmacokinetics and~     glucodynamic action of BioChaperone insulin lispro at 0.2U/Kg with Humalog® at 0.2 U/Kg and~     to assess safety and tolerability of BioChaperone insulin lispro and Humalog®.~      This is a double-blinded, randomised, four-period crossover phase 2 trial using automated~     12-hour euglycemic clamps in subject with type 1 diabetes mellitus.~      Each subject will be randomly allocated to a sequence of 4 treatments, i.e. with one of three~     single doses of BioChaperone insulin lispro (0.1, 0.2 and 0.4 U/Kg) or one single dose of~     Humalog® (0.2 U/Kg) on 4 separate dosing visits.~   "
108548|NCT02146638|"~     Aim of this study is to compare benefits and disadvantages in using continuous infusion of~     morphine or fentanyl for post operative analgesia.~   "
108549|NCT02146625|"~     The objectives of this study are:~        -  To evaluate the safety and tolerability of CJ-40002 after single SC injection in healthy~          male volunteers.~        -  To evaluate the PK of CJ-40002 after single SC injection in healthy male volunteers.~        -  To evaluate the PD of CJ-40002 after single SC injection in healthy male volunteers.~        -  To evaluate the ADA of CJ-40002 after single SC injection in healthy male volunteers.~   "
108550|NCT02146612|"~     The present study aims to evaluate the patient profile including medical conditions who use a~     nutritional supplement along with a balanced and varied diet in Turkey.~   "
108551|NCT02146599|"~     The purpose of this study is to evaluate the visual quality and function of pseudophakic~     patients.~   "
108552|NCT02146586|"~     This study outlines structured Clinical Evaluator (CE) testing techniques that are proposed~     to be implemented across all sites participating in the Cooperative International~     Neuromuscular Research Group (CINRG) research studies. The study will determine if the~     selected techniques are reliable and reproducible across the CINRG network by evaluating the~     reliability and reproducibility of the measures between CEs~   "
108553|NCT02146573|"~     This study will implement and evaluate the effects of a pediatric continuity care intensivist~     program. This study will determine the impact of an additional pediatric intensive care unit~     (PICU) intensivist on outcomes at the patient and family level. It will also evaluate the~     training program to prepare the continuity care intensivist (CCI).~   "
108554|NCT02146560|"~     Background to main study question: Cardiac complications are a common cause of morbidity~     after non-cardiac surgery. Patients with perioperative myocardial injury (both MI, and lower~     levels of cardiac troponin elevation) experience higher short-term and long-term mortality.~     They are also at substantially increased risk of additional cardiac and non-cardiac~     complications. It is therefore plausible that myocardial injury adversely affects quality of~     life. This study will compare postoperative health-related quality of life of patients who~     did or did not experience perioperative myocardial injury (defined by troponin-I > 0.07ng/ml)~     after non-cardiac surgery~      Study Design: Pilot prospective cohort study (n = 300). Population: Consecutive patients~     undergoing non-cardiac, non-transplant surgery at UHN.~      Background to secondary study questions:~        1. Clinically based risk stratification tools used in non-cardiac surgery (e.g., Revised~          Cardiac Risk Index) are of moderate utility and assign patients only to broad risk~          categories. This study will examine the usefulness of pre-operative biomarkers (BNP,~          HbA1c, and others) in supporting cardiac risk stratification and will address the~          question: Is there a set of preoperative criteria that can accurately inform the~          decision to monitor troponin postoperatively?~        2. Intra-operative physiological derangement measured with the Surgical Apgar Score~          correlates with morbidity and mortality 3-months postoperatively. This study will~          examine the relationship between the Surgical Apgar Score; continuous non-invasively~          monitored intraoperative metrics of hemoglobin concentration and occult hypovolemia~          (Pleth Variability Index) with the Masimo Radical-7 Pulse Co-Oximeter; and the primary~          and secondary outcomes. This aspect of the study will address the question: Can readily~          available intraoperative physiological data inform the decision to monitor troponin~          postoperatively?~        3. Quality of Recovery-40 Score evaluates (in the recovery room and at 24 hours~          postoperatively) the patient's subjective experience of their recovery from surgery.~          This metric is correlated with quality of life 3-months postop. This study will evaluate~          correlation between Quality of Recovery-15 Score, a valid and more efficient means of~          measuring recovery, and the primary and secondary outcomes.~        4. Approximately 2/3 of patients who have postoperative myocardial injury are asymptomatic~          and have no ECG changes. Diagnosis of MI requires biomarker elevation (Troponin >~          0.3ng/ml) plus clinical or ECG or imaging evidence of myocardial injury. Of the latter 3~          criteria, 2 are often absent. In selected patients, this study will use trans-thoracic~          echocardiography, CT coronary angiography, and cardiac MRI to improve diagnostic yield~          and define those diagnostic modalities that are most useful in the postoperative~          patient.~      Rationale:~      Postoperative myocardial injury may negatively impact health-related quality of life.~     Affected patients may experience higher levels of postoperative dependency. This possibility~     has implications for patient rehabilitation, provincial and personal healthcare costs, as~     well as patients' physical, emotional and mental well-being and relationships. The public~     health dimension of this problem could therefore be significant. In addition, an incomplete~     understanding exists of how individual patient cardiac risk factors, in combination with the~     perioperative environment, result in myocardial injury. The diagnostic investigations that~     are most useful in this setting have not yet been clearly defined. Patients who fail to be~     rescued after experiencing postoperative complications (as distinct from failure to avoid~     experiencing the complication in the first instance) plays a central role in postoperative~     mortality. Early recognition of such patients is therefore crucial. By prospectively~     observing a cohort of high-risk surgical patients, this study will provide insight into how~     these factors interact. This will allow us to better characterize the potential predictors~     and features of postoperative myocardial injury. We hope that our findings will aid in the~     identification of patient characteristics associated with increased risks of postoperative~     myocardial injury, thus helping to direct diagnosis, early treatment and rescue. This study~     will thus potentially yield important data that will positively impact future patient care~     and the rational use of healthcare resources.~   "
108672|NCT02145026|"~     This is a Phase IV, prospective, multi-center, open-label study to assess the effectiveness~     and safety profile of epoetin beta (Recormon®) for treatment of symptomatic anemia in adult~     participants associated with low/intermediate-1-risk MDS. After screening, eligible~     participants will be treated with epoetin beta as recommended in the approved label and~     international guidelines for the use of epoetin in MDS participants and the dosage will be~     adjusted on the basis of erythroid response.~   "
108555|NCT02146547|"~     Schizophrenia is a chronic psychiatric illness with periods of remission and relapse.~     Patients vary in the frequency and severity of relapse, time until relapse and time in~     remission. Discontinuation of antipsychotic medication is by far the most important reason~     for relapse. A possible method to optimize medication adherence is to treat patients with~     long-term, depot medication rather than oral medication. However, despite its apparent~     common sense this approach has neither been universally accepted by practicing~     psychiatrists nor unequivocally demonstrated in clinical trials. Therefore, in this study we~     aim to investigate possible advantages of depot medication over oral antipsychotics in an~     independently designed and conducted, randomized, pragmatic trial.~   "
108556|NCT02146534|"~     Phase 4, single center, double-blind, placebo-controlled study. Fifty (50) patients with~     MacDonald criteria (2005) multiple sclerosis will undergo active motor training as per the~     NeuroGym protocol, consisting of 3 sessions of 1 hour per week for a period of 6 weeks (total~     of 18 sessions).~      Half of the patients will be randomized to receive prolonged-release fampridine 10 mg BID as~     per label, and the other half will receive a placebo BID.~      All patients will continue to take their medication (fampridine or placebo) during a~     subsequent observational period of 8 weeks. Patients will be evaluated at times -4, 0, 6 and~     14 weeks.~      Study Objectives:~      Primary: To demonstrate that MS subjects treated with prolonged-release fampridine 10mg BID~     will show greater benefit from active motor training as compared with subjects treated with~     placebo in terms of incidence of responders, degree of response, and duration of response.~      Secondary: To demonstrate that MS subjects treated with prolonged-release fampridine 10mg BID~     will show greater benefit from active motor training as compared with subjects treated with~     placebo in terms of quality of life measures.~   "
108557|NCT02146521|"~     The purpose of the study is to compare the diagnosis and management (treatment and~     disposition) of adult emergency department patients with acute nontraumatic abdominal pain~     and tenderness, based on two CT techniques:~        1. Standard (complete) abdominal-pelvic CT. The American College of Radiology calls for the~          cephalad limit of abdominal CT to begin at the dome of the diaphragm, and the caudad~          limit of pelvic CT to extend through the ischial tuberosities.~        2. A z-axis restricted subset of images digitally obtained from the original CT dataset,~          determined by the region of tenderness identified by the examining emergency physician~          and marked on the patient prior to the performance of the CT. This z-axis restricted CT~          does not require any additional radiation exposure to the patient, as it will be~          produced by computer extraction of data from the original standard abdominal-pelvic CT.~      The investigators hypothesize that the diagnosis and management will not differ when guided~     by the two CT scan interpretations. Radiation doses will be calculated for each of the two~     techniques.~   "
108558|NCT02146508|"~     Esophageal cancer is common in Kenya. The precursor of esophageal cancer is esophageal~     squamous dysplasia (ESD). In this study, persons known to have ESD will undergo endoscopic~     removal or ablation of ESD in order to prevent development of esophageal cancer.~   "
108559|NCT02146495|"~     Fibromyalgia is a clinical syndrome characterized by extensive chronic pain. Today, the main~     theory argues the origin of the pain is central sensitization which is en amplification of~     processing and transferring neuronal signals. Patients usually suffers a wide range of~     symptoms: extensive pain, chronic fatigue disorders of sleep (having trouble falling asleep,~     fragmented sleep and early awakening) , mood disorders and cognitive damage. To treat the~     sleep disorder, the pain and the depuration with Fibromyalgia patients is a complex clinical~     challenge that usually requires combination of different medicines (short term analgesic +~     long term analgesics + anti-depressives and so on). Patients are also referred to other~     treatments such as cognitive behavioral therapy (CBT), occupational therapy treatment,~     phycisal therapy, alternative medicine and so on.~      Another such non-medical treatment is to try and modifies the patterns of activity of the~     patient's brain. One approach that draws attention in the last few years is EEG based~     neuro-feedback (NF). EEG NF is a closed circuit brain computer Interface (BCI) in which the~     patient gets a feedback from his or her own brain that signifies a certain mental state. The~     brain-patient feedback allows to train patients in performing a voluntary change of a~     dedicated brain area, such as pain related areas. In this study we intend to assess the~     effect of two different EEG-NF protocols targeting different brain areas as compared to~     placebo (sham) NF and drug therapy on pain and sleep quality measures in fibromyalgia~     patients.~   "
108560|NCT02146482|"~     The purpose of the study is to evaluate the changes in back pain from access to a sit-stand~     workstation. Other muscle and joint pain and/or discomfort will also be evaluated. We~     hypothesize that access to a sit-stand workstation will allow one to experience postural~     variation and reduce back pain.~   "
108561|NCT02146469|"~     The objective of the study is as follows:~        1. To know the antibody level during different interval after received 1 dose varicella~          vaccine.~        2. To know safety and effectiveness of received 2 doses varicella vaccine with different~          interval.~        3. To know safety and effectiveness of received varicella vaccine and MMR at the same time.~      To achieve that, this study selects children with specific varicella vaccine history, gives 1~     or 2 doses varicella vaccine, collects blood specimens and makes a follow-up visit after~     vaccination.~      All blood specimens will be tested by a third-party detection institution.~   "
108562|NCT02146456|"~     Colloid solution is generally used to maintain intravascular volume. It is reported to impair~     blood coagulation in vivo and in vitro more than crystalloid does by prolonging coagulation~     time and decreasing clot strength. The formed fibrin clot is more vulnerable for fibrinolysis~     in a case of using colloid. Dilution of plasmin in vitro with colloid enhances fibrinolysis~     primarily by diminishing α2-antiplasmin-plasmin interaction.~      Tranexamic acid is an antifibrinolytics that competitively inhibits the activation of~     plasminogen, by binding to specific site of both plasminogen and plasmin, a molecule~     responsible for the degradation of fibrin, a protein that forms the framework of blood clot.~     It is used to treat or prevent excessive blood loss during surgery and in other medical~     conditions. Gastrointestinal effect, dizziness, fatigue, headache, hypersensitivity reaction,~     or potential risk of thrombosis is reported as the adverse effect of tranexamic acid.~      We hypothesized that inhibition of plasmin by tranexamic acid after colloid administration~     can improve the colloid-induced clot strength impairment.~   "
108563|NCT02146443|"~     The purpose of this study is to measure test-retest reliability and validate the star shaped~     test of manual dexterity. The purpose of this is to see if there is any significant learning~     effect, and if the test can discriminate between individuals who are at their normal skill~     level, and when they are stressed and/or fatigued. The test is designed to test hand to eye~     coordination and precision control. This is done by following a star shaped track with a pair~     of a surgical scissors. this is done 10 times, 5 times clockwise and 5 times counter~     clockwise. Each time the scissors come into contact with the border of the track, an error is~     counted. Overall completion time is recorded. As a randomized crossover study, we will have~     20 test subjects complete the test 4 times. Each test will be conducted with a pause of two~     breaks between the tests. Before each test, the test subjects are randomized to: no~     intervention, physical fatigue prior to testing, distractions during the test or both~     physical fatigue prior to testing and distractions during the test. All participants will~     complete a test with all four interventions. Furthermore, a test-retest trial will be~     conducted on 4 test-subjects. Each subject will complete the test two times with no~     interventions, with two days apart.~   "
108564|NCT02146430|"~     The main objective of this trial is to compare change in weekly average daily pain score~     (ADPS) from baseline to Week 13 in subjects receiving either dose of DS-5565 versus placebo.~     Weekly ADPS is based on daily pain scores reported by the subject that best describes his or~     her worst pain over the previous 24 hours.~   "
108565|NCT02146417|"~     As both patients with end-stage kidney disease and society benefit tremendously from live~     kidney donation, the safety and well-being of kidney donors are highly important objectives~     in live kidney donation. Laparoscopic donor nephrectomy has several advantages over open~     nephrectomy, such as less post-operative pain, better quality of life and shorter hospital~     stay. Therefore, laparoscopic donor nephrectomy is nowadays the treatment of choice in most~     countries.~      So far, modifications of the technique of laparoscopic donor nephrectomy, i.e. hand-assisted~     and/or retroperitoneoscopic approaches, did not show a significant benefit with regard to~     safety as reflected by the conversion to open and postoperative complications rate. We~     therefore believe that further research should focus on the optimization of early~     postoperative pain and its concomitant use of opioids. Since non-steroidal anti-inflammatory~     drugs are contra-indicated before and after nephrectomy, the management of postoperative pain~     largely depends on the administration of opioids. Measures to reduce postoperative pain would~     also reduce the occurrence of postoperative nausea and vomitus, and postoperative bowel~     dysfunction.~      A recent pilot study performed by our group showed that the use of low pressure~     pneumoperitoneum was feasible and significantly reduced deep intra-abdominal and referred~     pain score during the first 72 hours after surgery. Previous studies performed by others show~     that low pressure pneumoperitoneum is associated with reduction of systemic inflammatory~     response, post-operative pain and analgesic consumption. Martini et al have shown that deep~     neuromuscular block improves surgical conditions during laparoscopic surgery with standard~     intra-abdominal pressure. To facilitate the use of low pressure pneumoperitoneum, deep~     neuromuscular block improves surgical conditions and might become a prerequisite for the use~     of low pressure pneumoperitoneum.~      Our hypothesis is that the combination of low pressure pneumoperitoneum and deep~     neuromuscular block improves quality of recovery in the early post-operative phase.~   "
108566|NCT02146404|"~     Iatrogenic hypoglycemia is the most frequent acute complication of insulin therapy in people~     with type 1 diabetes (T1DM). Recurrent hypoglycemic events initiate a process of habituation,~     characterized by suppression of hypoglycemic symptoms and lead to hypoglycemia unawareness,~     which in itself defines a particularly high risk of severe hypoglycemia. Recent evidence~     suggest a pivotal role for increased brain lactate transport capacity in the pathogenesis of~     hypoglycemia unawareness. However, there is uncertainty about the magnitude of this effect~     and whether such excess brain lactate is oxidizes as a glucose-sparing alternative energy~     source or acts as a metabolic regulator controlling brain glucose metabolism, oxygen~     consumption and cerebral blood flow.~      Objective: The primary objective of this study is to investigate the effect of hypoglycemia~     on brain lactate accumulation and regional cerebral blood perfusion in humans. The secondary~     objective is to assess whether this effect is a related to hypoglycemia unawareness or a~     consequence of T1DM per se.~      Hypothesis: The investigators hypothesize that hypoglycemia stimulates lactate transport over~     the blood-brain barrier leading to cerebral lactate accumulation and that this lactate~     accumulation is a function of prior hypoglycemic exposure frequency contributing to clinical~     hypoglycemia unawareness. Furthermore, the investigators expect that this effect of~     hypoglycemia on brain lactate accumulation is related to changes in cerebral blood flow~     (CBF).~   "
108567|NCT02146391|"~     This study is an open-label, randomized, single-center, single-dose, two-way crossover study~     of the PK properties of Androxal in healthy male subjects. Twelve male subjects will each~     receive a single dose of Androxal 25 mg in both the fed and fasting state.~   "
108568|NCT02146378|"~     The purpose of this study is to understand safety (e.g., occurrence of adverse drug reactions~     [ADRs]) and efficacy data on the long-term use of Vyndaqel Capsules (hereinafter referred to~     as Vyndaqel) in all patients who received this drug under actual use conditions after its~     marketing.~   "
108569|NCT02146365|"~     One possible mechanism of protection from pneumococcal disease with a killed whole cell~     vaccine is by altering the carriage of pneumococcus germs in the nose and throat of those who~     get the vaccine. This study will look at nasal swabs from toddlers who received a killed~     whole cell pneumococcal vaccine (PATH-wSP) in VAC-010 and compare them to nasal swabs from~     toddlers of the same age who did not receive the PATH-wSP vaccine. This information will be~     used to help further develop the PATH-wSP vaccine. The research will be done in Kenya at one~     site in Kisumu (KEMRI). The study will enroll healthy Kenyan toddlers (12-15 months of age)~     who are participating in the VAC-010 study (N=250) and whose parents provide consent for this~     study. In addition 50 healthy Kenyan toddlers of similar age who did not participate in the~     VAC-010 study will also be enrolled.~      The toddlers will be followed for 6 months and will have 5 study visits. During those study~     visits each toddler will have their nose and back of their throat swabbed. The material from~     the swab will be analyzed for the presence and type of pneumococcal and other germs. At the~     last visit, one blood sample (5 ml or approximately 1 tsp) will be obtained.~      There will be no direct benefit to the participants other than direct and immediate medical~     care as needed.~      Parents of all participants will provide written informed consent.~   "
108570|NCT02146352|"~     The purpose of this study is to demonstrate the safety and effectiveness of the AXIOS Stent~     with Electrocautery Enhanced Delivery System for endoscopic transenteric drainage of~     pancreatic pseudocysts.~   "
108683|NCT02144883|"~     This purpose of the study was to investigate the efficacy of telephone counseling to help~     pregnant women quit smoking. The investigators tested two hypotheses: 1) telephone counseling~     increases the overall cessation rate during pregnancy, and 2) the counseling effects can be~     maintained postpartum.~   "
108571|NCT02146339|"~     Polar lipids have a specific chemical structure: they are an essential component of human~     cell membranes, play a major role in the nervous system and also influence the metabolic~     pathways including the cholesterol metabolism.~      Polar lipids are used in food-processing industry for their emulsification properties. The~     most famous emulsifier is soya lecithin but milk also naturally contains natural emulsifiers~     such as polar lipids. Milk polar lipids are rich in sphingomyelin and they may have~     beneficial effects on lipid metabolism in the context of metabolic diseases of nutritional~     origin.~      The purpose of this research is to study the variation of sphingomyelin content at the~     ileum's end after the consumption of different doses of milk polar lipids, and consequences~     on the intestinal absorption and metabolism of fatty acids and cholesterol.~      The subjects will be taking three different test meals varying by their milk polar lipids~     content.~      It is a bi-centric study with a centre in LYON (Centre de Recherche en Nutrition Humaine~     Rhône-Alpes) and CLERMONT-FERRAND (Centre de Recherche en Nutrition Humaine Auvergne).~   "
108572|NCT02146326|"~     Healthcare providers play an important role in helping patients be actively involved in~     treatment and recover from mental illness. But mental health clinicians, like other~     healthcare providers, are at risk for experiencing burnout—feeling emotionally drained from~     their work, having cynical thoughts toward patients and others, and feeling little~     accomplishment in their work. Burnout can lead to problems for the clinician including poor~     overall health, depression, and lower job satisfaction. Burnout also can impact how~     clinicians perform on the job; for example, people with high levels of burnout take more time~     off, show lower commitment to their job, and are more likely to quit or be fired. There is~     some evidence that burnout can affect the quality of care for patients, but very little~     rigorous research has tested this assumption. The purpose of our study is threefold. First,~     we will investigate how patients perceive burnout in clinicians and whether (and/or how)~     burnout impacts the care they receive. Next, we will test an intervention to reduce clinician~     burnout called Burnout Reduction: Enhanced Awareness, Tools, Handouts, and Education~     (BREATHE). BREATHE brings together tools that mental health clinicians are already familiar~     with, including relaxation and mindfulness exercises, setting boundaries, using social~     supports, and changing negative thought patterns and replacing them with more helpful ways of~     thinking. We have found this intervention effective in reducing burnout in other~     organizations, but have yet to study whether it also can improve patient outcomes. Clinicians~     (approximately 200) who participate will receive either the BREATHE intervention or training~     in motivational interviewing, which could also improve patient involvement in treatment and~     patient outcomes, but is unlikely to significantly reduce clinician burnout. We will also~     recruit up to 600 adult patients served by participating clinicians. We will survey~     clinicians and interview patients over a 12-month period after the intervention to determine~     how the intervention impacts clinician burnout and patient perceptions of care (relationship~     with the clinician, degree of autonomy in decision making), patient involvement in care, and~     outcomes (confidence in managing mental health, symptoms, functioning, and hope). Finally,~     this study will use a statistical procedure called Structural Equation Modeling to test a~     theoretical model of the relationship between burnout and patient outcomes. Findings from~     this study will show whether reducing clinician burnout can improve patient outcomes and the~     quality of care that patients receive. Our intervention will have the potential to be easily~     implemented in a variety of settings where burnout is a problem. Knowing how clinician~     burnout impacts patient outcomes, and whether improving burnout can improve patient care, can~     help improve the healthcare system.~   "
108573|NCT02146313|"~     This is a Phase 1, multicenter, open-label, dose-escalation study of DMUC4064A administered~     by intravenous (IV) infusion every three weeks (q3w) to cancer participants. The study will~     employ a traditional 3 + 3 dose escalation design to determine the maximum tolerated dose~     (MTD) of DMUC4064A against platinum-resistant ovarian cancer. Once a q3w recommended Phase 2~     dose (RP2D) is identified, two expansion cohorts (one in platinum-resistant ovarian cancer~     and another in unresectable pancreatic cancer) may be evaluated to further characterize the~     safety and activity in these populations.~   "
108574|NCT02146300|"~     The purpose of this study is to find out how the provocation of the nose changes breathing~     style (specifically, frequency and tidal volume changes)~   "
108575|NCT02146287|"~     Preterm babies cared for in the intensive care nursery are exposed to amounts of light that~     are very different from the exposures to an unborn baby or the newborn term baby. Currently~     many nurseries try to protect premature babies from too much light. They may also try to~     create light conditions of day and night like many parent homes. Some studies have shown~     improvements in health and development of babies cared for in nurseries that try to change~     light for premature babies.~   "
108576|NCT02146274|"~     PROSPER (Patient-centered Research into Outcomes Stroke patients Prefer and Effectiveness~     Research) is a three year research project to create a national, sustainable model to improve~     decision-making and patient-centered stroke outcomes through comparative effectiveness~     research.~   "
108577|NCT02146261|"~     This study (Protocol No. E6011-J081-002) is a single-center, randomized, double-blind,~     placebo-controlled, single ascending dose (SAD) study to evaluate mainly the safety and~     tolerability of a single subcutaneous administration of E6011. A total of 32 subjects will be~     randomized into four cohorts (50, 100, 200 and 400 mg groups). Of eight subjects per cohort,~     six subjects will receive the single subcutaneous E6011 administration and two subjects will~     receive the single subcutaneous placebo administration.~   "
108578|NCT02146248|"~     The investigators' research group is working to develop a highly effective, low cost~     non-surgical method of permanent contraception for women. To support this goal, we need to~     know more about the normal fallopian tube (tube that passes the egg from the ovary into the~     womb). The purpose of this study is to learn about how menstrual cycles and hormonal~     contraceptives affect tubal patency. Normally there is an opening between the tube and uterus~     to permit the flow of fluid and cells. If this opening is blocked, this can result in~     infertility. Tubal patency is when a woman's fallopian tubes are not blocked. Tubal patency~     is determined by an x-ray test called a hystero-(uterus)salpingo-(fallopian tube)graphy~     (HSG). HSG is a standard radiological imaging study that is used to determine if the~     fallopian tubes are open and free of disease. It is commonly done in women with an~     infertility diagnosis. The investigators usually do this test in the first 10 days of the~     menstrual cycle. Sometimes the tubes will appear to be blocked on the HSG when they are~     actually open. The timing of the HSG study during the menstrual cycle, or the use of hormonal~     contraception may make a difference in whether the tubes appear blocked on the HSG when they~     are actually patent.~      The results of the HSG test provide a good model for how our nonsurgical permanent~     contraception method might work. The investigators think that if the tubes are not patent,~     that our treatment will not work as well. Therefore, in this study we want to learn if~     menstrual cycle timing or current hormonal contraception use will affect the patency of the~     tubes as assessed by the HSG. The investigators want to examine the same women to see if~     tubal patency is changes during the menstrual cycle and during the use of a birth control~     pill and the birth control shot.~   "
108684|NCT02144870|"~     The main purpose of this study is to evaluate the efficacy of a habit reversal based~     treatment programme compared to an alternative treatment which aims at the activation of~     resources in children and adolescents aged 8 to 18 years with tic disorders.~   "
108579|NCT02146235|"~     The investigators combine traditional medical care with an integrative modality - Music~     Therapy specifically including wind playing, singing, and music visualizations- to study the~     effects on physical function and quality of life for adults with COPD. The primary goals are~     to increase respiratory function and reduce respiratory symptoms and hospitalizations in~     order to improve breathing, functional capacity for activities of daily living, psychological~     well-being and quality of life in adult age 45 and above who are diagnosed with COPD~   "
108580|NCT02146222|"~     This partially randomized phase I trial studies the side effects and how well sequential~     dosing of vascular endothelial growth factor receptor (VEGFR)/platelet derived growth factor~     receptor (PDGFR) dual kinase inhibitor X-82 and docetaxel works in treating patients with~     solid tumors. VEGFR/PDGFR dual kinase inhibitor X-82 may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as~     docetaxel, work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Giving VEGFR/PDGFR~     dual kinase inhibitor X-82 and docetaxel one at a time instead of concurrently may work in~     treating patients with solid tumors.~   "
108581|NCT02146209|"~     The purpose of this study is to determine whether Terix Labs Ltd Metronidazole benzoate (400~     mg Metronidazole Per Sachet Oral Granules) is bioequivalent to 500 mg Sanofi-aventis Flagyl~     125 mg/5 ml (125 mg Metronidazole Per 5 ml Suspension) and to Zentiva Flagyl™ 400 mg Tablets~     (400 mg Metronidazole Per Film Coated Tablets).~   "
108582|NCT02146196|"~     Robotic assisted gait therapy with the Lokomat® as a new method for rehabilitation in~     advanced heart failure and after cardiac surgery.~   "
108583|NCT02146183|"~     The aim of this experiment is to investigate if intake of stevioside in addition to a~     carbohydrate-containing composition after work related depletion of muscle glycogen will~     increase the rate of glycogen re-synthesis as compared with intake of the~     carbohydrate-containing composition alone.~   "
108584|NCT02146170|"~     Background:~      - Lung cancer is the leading cause of cancer-related death worldwide. It causes more than one~     million deaths every year. Researchers want to gather tissue samples from people with lung~     and thymic cancers to understand the disease better. This may lead to new ways to diagnose~     and treat it.~      Objective:~      - To collect tissue samples for use in the study of lung cancers.~      Eligibility:~      - Adults over age 18 with non-small cell lung cancer, small cell lung cancer, extra pulmonary~     small cell cancer, pulmonary neuroendocrine tumors, and thymic epithelial tumors.~      Design:~        -  Participants will be screened with a medical history, physical exam, and blood tests.~          They will be asked about how they perform their daily tasks.~        -  Participants may be asked to give urine and blood samples. They may give a saliva sample~          if they cannot give blood. They will also give a sample of their tumor from a biopsy~          they had. They may also be given the option to undergo a biopsy.~        -  Participants may have MRI, CT, and/or PET scans of the body. They will lie in a machine~          that takes pictures of the body.~        -  After visits to the Clinical Center end, researchers will contact participants by phone~          every year to check on their health.~   "
108585|NCT02146157|"~     This is a multi-center, randomized, double-blind, placebo-controlled study in approximately~     104 subjects (52 per group) to evaluate the effectiveness of an herb and mineral combination~     product on fasting serum glucose levels in subjects with impaired fasting glucose. The study~     consists of 5 visits: a Screening visit, followed by a Baseline visit (at which eligible~     subjects will be randomized to product to consume throughout the 12-week supplementation~     period), followed by Supplementation period visits at 3, 6 and 12 weeks after baseline.~   "
108586|NCT02146144|"~     The epimacular membrane (EMM) is a degenerative condition associated with age, with a~     variable impact on vision. Treatment is surgery based and consists of a vitrectomy followed~     by a peeling of the epimacular membrane using a microgripper. Peeling of the internal~     limiting membrane (ILM) is an adjuvant action that is now frequently practiced and which is~     expected to increase the success rate of EMM surgery by reducing the risk of recurrence of~     EMM. Although ILM peeling does not seem to have an adverse effect on visual acuity, it is not~     totally without consequence, it involves the risk of histological disorganization of the~     retina at the origin of one or several microscotomas, which are themselves responsible for a~     final visual discomfort. These microscotomas, resulting in the perception of somewhat black~     spots visible near the fixed point or the fixed image, may be highlighted by microperimetry~     and would be a loss of functional opportunity for the patient.~      In addition, recurrence of EMM, which the ILM peeling is supposed to diminish, does not alter~     the vision in half the patients. Furthermore, for those patients who are functionally~     affected by any such recurrence, a second epimacular membrane peeling surgery can be done.~      The main objective of this study is to compare the difference in microscotoma(s) before~     surgery and 6 months later, between an active ILM peeling group and a no ILM peeling~     group. Given the more invasive nature of ILM peeling, the investigators believe that the rate~     of microscotomas in these patients is higher than those without peeling.~   "
108587|NCT02146131|"~     The purpose of this study is to compare the yield of two methods for obtaining a lung tissue~     sample: Procedure #1: standard fiberoptic bronchoscopy (FB) with fluoroscopy, and Procedure~     #2: ultrathin bronchoscope procedure with fluoroscopy and radial endobronchial ultrasound~     (R-EBUS). These two procedures are similar in that they both: (1) enable your doctor to look~     inside your lungs with a device called a bronchoscope, and (2) Use fluoroscopy, which is a~     technique that uses X-rays to see your lungs.~      This will give the doctor an opportunity to use either of the bronchoscopy methods described~     above and compare the tests to see if R-EBUS provides better results than standard~     bronchoscopy.~   "
108596|NCT02146014|"~     Tobacco addiction is treatable with behavioral and pharmacological means, but results are~     often less than optimal. Transcranial direct current stimulation is a new non-invasive~     technique that applies weak electrical currents through the skull and has been shown to alter~     the excitability of certain brain areas. It is currently being tried in disorders where there~     is abnormal brain excitability, such as epilepsy and depression. A few studies have also been~     able to diminish drug craving, suggesting that brain excitability might also be altered in~     drug addiction.~      This study aims at non-invasively changing the excitability of certain brain areas-a~     procedure called neuromodulation- in order to help smokers quit smoking more easily.~   "
108588|NCT02146118|"~     1. Title and stage of study A Phase II Study to Assess Efficacy of Combined Treatment with~          Erlotinib (Tarceva) and Silybin-phytosome (Siliphos) in Patients with EGFR mutant lung~          adenocarcinoma~        2. Endpoints Primary Endpoint : tumour response rate Secondary Endpoint : progression-free~          survival, overall survival, and safety assessment~        3. Study Rationale Even though it is commonly accepted that EGFR TKIs are effective to EGFR~          mutation positive lung cancer patients, still remains its resistance issue.~           The Silybin which is extract from mugwort bean Thistle and used for hepatoprotective~          drug for a long time with very low adverse events in Eastern countries. Recently, there~          are some reports regarding its anti-cancer effects through several preclinical studies.~           The safety of Siliphos which is developed agent from silybin for improving intestinal~          absorption was demonstrated in PhaseⅠtrial.~           Recently investigators found out Silybin is effective for blocking EGFR signal in~          different mechanism from Erlotinib and it can be expected additional impact with~          combination therapy with preclinical data.~           Our research team can expect to improve Lung cancer treatment if the combination therapy~          (Silybin_Erlotinib) improves patients' response and Overall survivor.~        4. Treatment method Erlotinib (Tarceva 150 mg/day) and Silybin (Siliphos 1g bid/day) q 4~          weeks~        5. Assessment criteria For toxicity assessment, posttreatment recurrence and survival rates~          will be investigated based on NCI-CTCAE ver 4.0 and RTOG. Efficacy assessment will be~          conducted through measurement of lesions by CT and RECIST criteria. Overall survival~          (OS), progression-free survival (PFS), and time to tumour progression (TTP) will be~          estimated using a Kaplan-Meier analysis. In addition, effect of pre-treatment T790M on~          response and PFS will be analyzed.~   "
108589|NCT02146105|"~     Keeping individuals with knee osteoarthritis physically active is critically important.~     Exercise is effective at reducing pain while improving physical function. However some~     exercises can overload the knee, and as a result, worsen knee pain and health of the knee~     joint. Yoga offers a foundation of static postures that improve muscle strength and joint~     flexibility. Using sophisticated technology that allows us to calculate the loads inside the~     knee, the investigators have selected yoga exercises that do not overload the knee joint. The~     investigators have designed a yoga exercise class that is ideal for people with knee~     osteoarthritis. The purpose of the study is to investigate whether these yoga exercises~     increase muscle strength and reduce knee pain in women with knee osteoarthritis. In addition,~     the investigators aim to show that these yoga exercises will also improve knee loads during~     activities, mobility and heart health. The investigators will ask 50 women with knee~     osteoarthritis to participate in a 12 week yoga exercise intervention, that requires~     attendance to 3 classes each week. The investigators will test strength of the leg muscles,~     pain, knee joint loads, mobility and cardiovascular health before and after the 12 week yoga~     exercise intervention.~   "
108590|NCT02146092|"~     After any surgery, there is a chance of complications. After lung surgery to remove tumours,~     there is a particularly high chance of a person developing an infection or needing help~     breathing, called post operative pulmonary complications. Currently, the risk of these~     complications is reduced through the completion of light physical and deep breathing~     exercises and walking around as soon as possible after surgery. Another possible way of~     helping these patients is to use a small device called an Incentive Spirometer to encourage~     and measure deep breathing. This study wants to compare how often postoperative pulmonary~     complications happen after major lung surgery between a group completing the exercises alone~     and a group using the Incentive spirometer in addition to the exercises. It is hoped that the~     combined therapy will reduce the amount of time patient must stay in hospital, have fewer~     complication events and have fewer patients re-admitted back into the hospital after they go~     home, so that patients overall have better outcomes.~   "
108591|NCT02146079|"~     This trial is conducted in Asia. The aim of the trial is to investigate the pharmacokinetics~     (the exposure of the trial drug in the body), pharmacodynamics (the effect of the~     investigated drug on the body), and the safety and tolerability of semaglutide in healthy~     male Japanese and Caucasian subjects.~   "
108592|NCT02146066|"~     The study is an open-label expanded access study for patients for whom vaccine was~     manufactured during the Northwest Biotherapeutics' 020221 DCVax-L for GBM screening process,~     but who subsequently failed to meet specific enrollment criteria. Patients will receive~     therapy per investigator discretion (standard of care) as well as active vaccine per the~     020221 protocol administration schedule. It is estimated that approximately 99 patients will~     enroll in this study.~   "
108593|NCT02146053|"~     Oral iron supplementation is often associated with rapid onset of gastrointestinal~     side-effects. The aim of this study was to develop and trial a short, simple questionnaire to~     capture these early side-effects and to determine which symptoms are more discriminating.~      The study was a double-blind placebo-controlled randomized parallel trial with one week~     treatment followed by one week wash-out. Subjects were randomized into two treatment groups~     (n=10/group) to receive either ferrous sulphate (200 mg capsules containing 65 mg of iron) or~     placebo, both to be taken at mealtimes twice daily during the treatment period. Subjects~     completed the questionnaires daily for 14 days. The questionnaire included gastrointestinal~     symptoms commonly reported to be associated with the oral intake of ferrous iron salts (i.e.~     nausea, vomiting, heartburn, abdominal pain, diarrhoea, and constipation).~   "
108594|NCT02146040|"~     The aim of this study is to evaluate the role of atrial fibrillation (AF) and its treatment~     in relation to thromboembolic events (stroke, and transient ischemic attacks) and~     intracranial hemorrhage.~      Primary Outcome Measures:~      - Incidence and timing of intracranial complications (stroke,TIA, bleedings) in relation to~     diagnosis and anticoagulation treatment of AF during the study period; comparison of~     complications between those with and without anticoagulation treatment according to CHADSVASc~     score.~      Secondary Outcome Measures:~        -  The effect of anticoagulation pauses and INR level on stroke and bleeding risk; strokes~          within 30 days after anticoagulation pause and the prevalence of stroke and intracranila~          bleeding in relation to INR level < 2, 2-3 and >3.~        -  Trauma as a risk factor for intracranial bleeding: percentage and risk factors for~          intracranial bleeding with or without trauma. Type of preceding trauma and type of~          intracranial bleeding.~        -  The time relation between diagnosis of AF and type of intracranial complications: Kaplan~          Meier analysis of thrombotic (Stroke/TIA) and intracranial bleeding complications after~          1st diagnosis of AF in patients with and without anticoagulation~        -  The risk of stroke and intracranial bleeding in relation to CHADSVASc score, HAS-BLED~          score and anticoagulation/antithrombotic treatment~        -  Prognosis of stroke and intracranial bleeding: 30-day mortality after stroke and~          intracerebral bleeding in patients with and without anticoagulation~        -  Factors related to underuse of anticoagulation treatment. Data on reasons for not~          starting or stopping aticoagulation in those with indication of oral anticoagulation~        -  Operations and procedure as risk factor for stroke: Frequency and type of operations~          performed < 30 days before stroke. Data on length of perioperative pause in~          anticoagulation and use of bridging therapy and timiing of stroke are collected.~        -  Cardioversions as a risk factor for stroke: Frequency of stroke and TIA < 30 days after~          cardioversion in relation to use of anticoagulation and CHADSVASc score~        -  The risk of stroke and intracranial bleeding in relation to type of AF (permanent,~          persistent, paroxysmal) and concomitant carotid disease~      Estimated Enrollment: 6000 patients.~   "
108595|NCT02146027|"~     In this study, HIV-infected patients with poor recovery of CD4+ T cells and successful viral~     control after treatment with antiretroviral therapy will be enrolled to receive once a day~     Lactobcillus casei Shirota or placebo in a double-blind, randomized fashion. Immune~     parameters will be monitored for 12 weeks in both arms.~      The main outcome is CD4+ T cell recovery. Secondary outcomes will include NK cells and T~     cells immune parameters.~   "
108607|NCT02145871|"~     The purpose of this study is to help us learn what is the best amount of fluid to give to~     patients during bladder surgery in order to avoid delayed bowel function after surgery, which~     could prolong hospital stay.~   "
108597|NCT02146001|"~     This study is a randomized trial that will compare the effects of two, 12-week activity~     interventions on patterns of physical activity, physical health, and quality of life measures~     in 40 older adults who are able to walk for exercise. One intervention will target 150~     minutes per week of home-based moderate exercise (e.g. brisk walking), consistent with~     current recommendations. The other intervention will target a decrease in time spent in~     sedentary behaviors (e.g. sitting) of 60 minutes per day. Both interventions will wear an~     activity armband which will allow them to self-monitor their activity or sedentary behavior~     in real time using a smartphone. The armband will also provide objective data to an~     interventionist that will facilitate the intervention. The main outcome will be time spent in~     moderate exercise.~   "
108598|NCT02145988|"~     This is a prospective, randomized, double-blind, double-dummy, and controlled study of~     DLBS1033 for the improvement of ankle-brachial index in diabetic patients with peripheral~     arterial disease (PAD). It is hypothesized that the addition of DLBS1033 on top of aspirin~     treatment will augment significantly the resting ABI in diabetes patient with PAD in~     comparison with that of aspirin alone.~   "
108599|NCT02145975|"~     Fentanyl is a potent opioid, it is theoretically 100 times more potent that morphine and in~     severe acute postoperative pain acts faster than its congener (morphine ) for pain relief .~     In the literature there is no study that corroborates this theoretical assumption and~     proposes to compare which has fewer adverse effects. This drug produces effects similar to~     those reported for morphine but less magnitude and has the advantage that during the~     postoperative period respiratory depression, antitussive effect , gastrointestinal discomfort~     and physical dependence are manifested in a significantly less degree.~      Trying to solve the management of postoperative pain relief , our objective is to determine~     by controlled clinical trial of superiority if in adult patients undergoing surgery ,~     fentanyl reduces faster qualification time of severe pain to mild pain in the postanesthesia~     care unit compared to morphine.~   "
108600|NCT02145962|"~     An open multicenter trial to document the efficacy and safety of two therapeutic Extremely~     Low Frequency Magnetic Fields stimulation devices to promote wound healing of Diabetic Foot~     Ulcers.~   "
108601|NCT02145949|"~     As a function of the growing population of older adults, an estimated 3.48 million total knee~     arthroplasty (TKA) procedures will be performed annually in the U.S. by 2030. Despite the~     near-universal success of this surgery in mitigating chronic knee pain, TKA is not successful~     in restoring long-term physical function in older adults, primarily because of quadriceps~     muscle atrophy, which explains 77% of the strength deficits. Overall, strength and functional~     mobility in TKA patients is 30-50% below age-matched healthy controls. Functional tasks such~     as stair-climbing remain a clinical problem for 75% of patients following TKA. Muscle atrophy~     occurs in both operative and non-operative legs, and is essentially permanent for older~     patients because of their impaired ability to increase muscle mass. The purpose of this~     clinical research is to determine the effects of essential amino acid (EAA) supplementation~     on muscle mass, strength, and functional mobility following TKA in older adults. Based on~     strong preliminary data, the investigators hypothesize that twice-daily ingestion of 20 g of~     EAA for 1 wk before through 6 wk after TKA will increase basal rates of muscle protein~     synthesis via inactivation of catabolic signaling, and up-regulation of anabolic and~     cyto-protective proteins. The investigators further hypothesize that short-term atrophy~     prevention and accelerated return of functional mobility will lead to longer-term structural~     and functional adaptations, and improved quality of life in older TKA patients vs. Placebo.~     Identifying the mechanisms up-regulated by EAA treatment that preserve muscle volume and~     mobility will have a major impact on rehabilitation science. This study will accomplish two~     specific aims: (1) determine if EAA elevates basal rates of muscle protein synthesis by~     up-regulating anabolic pathways and cyto-protective proteins, and inactivating catabolic~     pathways in the short term vs. Placebo and (2) determine if short-term prevention of atrophy,~     weakness, and functional mobility leads to positive changes in muscle cell structure and~     function, and improved quality of life in the longer term vs. Placebo. This work is~     significant because it advances knowledge of the molecular and cellular changes occurring~     during muscle atrophy (Placebo) and atrophy prevention (EAA) in a clinical setting using a~     treatment that is broadly applicable, is well tolerated, and can be implemented immediately.~   "
108602|NCT02145936|"~     The purpose of this study is to to determine the effect of habituation to diets with~     different types of dietary fat (stearic, palmitic and oleic) on selected Cardiovascular~     Disease (CVD) risk indicators with an emphasis on inflammation.~   "
108603|NCT02145923|"~     Subjects will undergo peripheral blood stem cell mobilisation and collection with subsequent~     high-dose chemotherapy. After finalization of high-dose chemotherapy subjects will receive~     bone marrow derived allogeneic multipotent mesenchymal stromal cells intravenous infusion two~     hours prior to autologous peripheral blood cells infusion. This is a single arm study with no~     control. All patients receive cell therapy.~   "
108604|NCT02145910|"~     This phase I trial studies the best dose of vemurafenib when combined with whole brain~     radiation therapy (WBRT) or stereotactic radiosurgery (SRS) in patients with v-raf murine~     sarcoma viral oncogene homolog B (BRAF) mutation-positive melanoma and brain metastases.~     Radiation therapy is an effective treatment for patients with brain metastases. Patients with~     multiple metastases are typically treated with WBRT. For patients with a few metastases, SRS~     alone can be used. Vemurafenib may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Combining radiation treatment with vemurafenib for melanoma~     patients with brain metastases may result in improved local control and prolonged survival.~   "
108605|NCT02145897|"~     Various preclinical animal studies have shown the potential of stem cells in re-vascularising~     ischemic limbs and promoting collateral vessel formation. SVF have the potential to~     facilitate the formation of new blood vessels and skeletal muscle. Early pilot clinical~     studies indicate that stem-cell transplantation is feasible and may have beneficial effects~     in CLI. Injury or inflammation is a prerequisite for the participation of circulating stem~     cells to home and differentiate on to this microenvironment. The increased vascular~     permeability and expression of adhesion proteins like integrin assist in stem cell homing.~     The migratory capacity of stem cells is dependent on natural growth factors such as vascular~     endothelial growth factor (VEGF), Stromal cell derived factor (SDFI) and stem cell factor~     (SCF). The expression of VEGF, SDFI and SCF is highly unregulated in the hypoxic muscular~     tissue and is responsible for the recruitment of the stem cells to assist in the repair~     mechanism and consequent improvement in limb function.~      In addition to the above regenerating potential of SVF, they have several advantages; they~     can be easily isolated without further culturing it. Most importantly SVF have shown to have~     significantly highest expression of pluripotent markers similar to that of human embryonic~     stem cells and yet they are non-tumorogenic and safe.~      MSCs are having angiogenic activity and hence may be excellent source to develop~     neo-vasculature and hence could be explored for their therapeutic potential for treating~     Critical Limb Ischemia. MSC's also display membrane-bound and insoluble secreted molecules~     involved with cell attachment to neighbouring cells and to the extra cellular matrix19~     Adipose derived Stromal vascular fraction and Mesenchymal Stem Cells has been found in~     preclinical studies to be safe and effective.~      The current Phase I/II study of adipose derived stromal vascular fraction and Mesenchymal~     stem cells is conducted with the broad objective of establishing safety and efficacy.~   "
108606|NCT02145884|"~     We plan to conduct a study, to see how safe and effective timolol maleate 0.5% gel-forming~     solution is for infantile hemangiomas (IH) and the response of hemangiomas to timolol maleate~     0.5% . Our hypothesis is that timolol will inhibit and possibly reverse growth of appropriate~     infantile hemangiomas.~   "
108608|NCT02145858|"~     Postoperative bleeding is a common consequence after heart surgery which can significantly~     impact outcomes and costs . When bleeding occurs, reliable postoperative blood evacuation of~     the pleural, mediastinal and pericardial spaces with chest tubes is imperative to facilitate~     pulmonary reexpansion and mediastinal decompression as the patient recovers. When~     postoperative blood evacuation is inadequate, complications from retained blood can result.~     Clinically, retained blood may be recognized acutely or sub acutely. The acute clinical~     presentation is usually blood and fresh thrombus around the heart or lungs presenting as~     tamponade or hemothorax. The subacute clinical presentation is bloody pleural or pericardial~     effusions. These effusions are often driven by the breakdown of remaining thrombus. Once~     retained blood occurs, subsequent procedures may be needed to remedy it. Interventions to~     remove postoperative pericardial and/or pleural fluid or blood and reoperations due to~     bleeding are captured under a composite termed Retained Blood Syndrome, or RBS. The need for~     treatment and interventions for these conditions represents an impediment to patient recovery~     and involves both resource and economic consumption for a heart program and the healthcare~     system at large.~      A recent review of the literature indicates that additional procedures for RBS are~     demonstrated in approximately 15% to 20% of patients after heart surgery. In a prospectively~     collected US Nationwide Inpatient Sample (NIS) data from 2010, RBS could be demonstrated in~     17% of patients. In this analysis, mortality was doubled from 4% to 8%, length of stay was~     increased by 5 days, and average costs were 55% higher. Patients with RBS, therefore,~     represent an increased at-risk population for complications and costs.~      Postoperative obstruction of conventional chest tubes with blood and other fibrinous material~     in the setting of postoperative bleeding contributes to RBS. In a study of postoperative~     cardiac surgery patients at the Cleveland Clinic, 36% of patients were found to have evidence~     of chest tube obstruction. Active Clearance with PleuraFlow has been shown to prevent chest~     tube clogging, and reduce RBS.~      The purpose of this registry is to evaluate the effectiveness of the PleuraFlow System, a~     commercial Class II (US), Class IIb (Canada, Europe, and Australia), in the management of~     blood evacuation after cardiac surgery.~   "
108609|NCT02145845|"~     This study is intended to collect safety and effectiveness data on the Cook Injectable Small~     Intestinal Submucosa (SIS)~   "
108610|NCT02145832|"~     This study is designed to determine whether micafungin is as efficacious as the current~     standard of fluconazole, to compare the safety of the two drugs in the treatment of proven~     neonatal candidiasis.~      It is also designed to further elucidate the pharmacokinetics of the two products in the~     growing and developing neonate and premature infant.~   "
108611|NCT02145819|"~     The aim of the study is to determine whether spontaneous LH peak is superior to human~     chorionic gonadotropin before a transfer of a day 3 frozen embryo.~   "
108612|NCT02145806|"~     1. Validation of the Korean version of the ICIQ-UI SF for pregnant and postpartum women~        2. Evaluation the effect of urinary incontinence in pregnant and postpartum women.~   "
108613|NCT02145793|"~     Attention deficit hyperactivity disorder (ADHD) affects 8% of US youth. Even though evidence~     shows medications are effective in reducing ADHD symptoms, many families experience ongoing~     parenting stress around parent-child interactions. Children often have ongoing impairments in~     functioning. ADHD is a common condition identified and managed by primary care pediatricians.~     However current care in the clinic is not optimal to address parents' and children's needs~     around ADHD chronic care. Time is the biggest barrier. Group visits are a viable option to~     improve pediatric ADHD care, but requires extensive study. The goal of this proposed study is~     to test the feasibility and effectiveness of the group visit model for ADHD management within~     pediatric primary care. This study will be a randomized feasibility study that will generate~     important pilot data, as well as result in an innovative, exportable pediatric ADHD group~     curriculum for primary care practice.~   "
108614|NCT02145780|"~     Obesity is a complex and multifactorial disease representing a major public health challenge.~     Indeed, overweight and obese people carry a major risk of developing insulin resistance and~     type 2 diabetes mellitus. It has been demonstrated that polyphenols could be used to~     counteract some of the mechanisms involved in the generation of insulin resistance. The model~     of overfeeding represents a very good study model of the metabolic complications of obesity,~     since it has been shown to induce a transient state of insulin resistance in the human.~      The purpose of this research is to study the effects of a overfeeding (+50% of daily caloric~     needs over 31 days) with or without polyphenols supplementation (2g/days over 31 days) on~     insulin sensitivity measured in the setting of a hyperinsulinemic euglycemic clamp and on~     post prandial partitioning of exogenous lipids after a test meal.~      During 31 days, the volunteers will consume chocolate bars, chips, chocolate breads and cola~     in addition to their usual diet and will be supplemented with 2g of grape polyphenols extract~     or with placebo.~   "
108615|NCT02145767|"~     Miscarriages and preterm births are common and serious events affecting women, families, and~     healthcare systems on many levels. One of the risk factors for miscarriage and preterm birth~     is bleeding in the first trimester of pregnancy. Progesterone, a hormone that plays a key~     role during pregnancy, has been proposed as a possible medication to be used in pregnancy to~     prevent miscarriage and preterm birth among women who have bleeding in their first trimester~     of pregnancy. Unfortunately, unless sound clinical evidence is obtained through a clinical~     trial, whether or not progesterone can indeed prevent miscarriage and preterm birth remains~     uncertain and thus is not a recommended treatment in women with early pregnancy bleeding. The~     purpose of our study is to evaluate the effect of progesterone for the prevention of~     miscarriage and preterm birth among women with early pregnancy bleeding. We will carry out a~     clinical trial in which 850 women will be randomized to receive either progesterone~     supplementation (425 women) or a similarly appearing placebo (425 women) and the outcome of~     their pregnancy will be compared.~   "
108616|NCT02145754|"~     The main purpose of this study is to compare effectiveness of two different culture media for~     cultivation of Borrelia burgdorferi sensu lato from skin specimens obtained from patients~     with erythema migrans.~   "
108617|NCT02145741|"~     This open-label dose escalation phase I trial, 1280.15, is with the first administration of~     BI 836845 in Japanese patients with various types of advanced solid tumours. The rationale~     behind this study is to identify the maximum tolerated dose (MTD) of BI 836845 in Japanese~     patients with advanced solid tumours as weekly intravenous administration.~   "
108618|NCT02145728|"~     The purpose of this study is to evaluate whether individual cognitive functional therapy~     (CFT), when compared to group exercise classes is effective in reducing pain and disability~     in patients with non-specific chronic low back pain.~   "
108630|NCT02145572|"~     The purpose of this study is to identify unique metabolite signatures associated with the~     development of Type 2 diabetes and diabetic kidney disease in children.~      We have a sub-study, with the purpose to validate the presence of a genetic marker (DENND1A)~     in the urine of adolescent females with polycystic ovarian syndrome.~   "
112157|NCT02099409|"~     The purpose of this study is to validate current algorithms and evaluate safety and efficacy~     of overnight closed loop insulin delivery (FlorenceD2 system) in children with type 1~     diabetes between 6 - 12 years of age in Luxembourg .~   "
108619|NCT02145715|"~     Velcade (bortezomib), thalidomide and dexamethasone (VTD) has been demonstrated to be a~     highly effective combination in both patients with previously untreated and those with~     relapsed multiple myeloma. In previously untreated patients VTD demonstrated clear~     superiority to TD as induction therapy prior to planned tandem autologous stem cell~     transplant.~      The rationale of this trial is to combine a 'gold standard' antiMM combination with the HDAC~     inhibitor Panobinostat. There is emerging data to support the concept of clinical synergy~     between BTZ and HDACi's.~      The purpose of this study is to determine the maximum tolerated dose (MTD) and estimated~     response rates of panobinostat, administered in combination with VTD, in subjects with~     relapsed and relapsed/refractory multiple myeloma.~   "
108620|NCT02145702|"~     The purpose of this study is to evaluate the impact of 12 weeks of exercise on cognition in~     patients with end stage renal disease.~   "
108621|NCT02145689|"~     This is a long-term safety and efficacy study of onabotulinumtoxinA in poststroke patients~     with upper limb spasticity.~   "
108622|NCT02145676|"~     This is a safety and efficacy study of onabotulinumtoxinA in poststroke patients with upper~     limb spasticity.~   "
108623|NCT02145663|"~     The aim of this study is to establish diagnostic and predictive biomarkers for patients with~     suspected acute stroke, that are transported by EMS as candidates for thrombolytic treatment.~     The study focuses on the ultra acute phase, <4.5 hours from symptom onset, including the~     prehospital setting. Analyses will include known biomarkers (e.g. GFAP, NR2 peptide) and a~     discovery phase for novel markers. Patient outcome will be evaluated at 3 month using the~     modified Rankin Scale (mRS).~   "
108624|NCT02145650|"~     This study will examine the epidemiology (incidence and control of a disease), burden,~     clinical need, and treatment patterns of spasticity in patients with a diagnosis of Cerebral~     Palsy (CP), Multiple Sclerosis (MS), Stroke, Spinal Cord Injury (SCI), or Traumatic Brain~     Injury (TBI).~   "
108625|NCT02145637|"~     This phase Ib study will investigate dose limiting toxicity (DLT) and maximum tolerated dose~     (MTD) of afatinib and ruxolitinib combination therapy, based on the preclinical data that~     inhibition of IL-6R/JAK1 signal transmission pathway will increase sensitivity to afatinib.~   "
108626|NCT02145624|"~     Due to an unexpectedly high number of infant deaths from whooping cough in 2012, the~     Department of Health acted to protect newborns between birth and completion of primary~     immunisations, the period with greatest risk of disease.~      Vaccination of pregnant women with whooping cough vaccine in the third trimester of pregnancy~     was instigated nationally, so that antibodies produced by the Mum would cross the placenta to~     the unborn child, giving them passive protection at the most vulnerable time. This antibody~     transfer has been known for some time but has not been compared between the two whooping~     cough vaccines being used in pregnancy. Any effect the raised antibody might have on infant~     responses to the vaccines given in the first few months of life has also not been measured.~     This is particularly important as the infant immunisations include some of the same~     components as the whooping cough vaccines, which include diphtheria, tetanus and polio.~     Previous studies have shown that high levels of antibody prior to vaccination may affect~     subsequent antibody responses. It is therefore important to assess whether administration of~     the whooping cough vaccine in pregnancy adversely affects the protection afforded by the~     infant vaccines, particularly to those which are similar, namely tetanus and diphtheria as~     well as meningitis C and Hib vaccines which include diptheria and tetanus components in their~     structures. This study will assess immune responses of mothers and their babies (~200 pairs)~     to their vaccinations and will allow the comparison of two whooping cough vaccines being used~     in pregnancy. This will be done by taking small amounts of blood, which is the only way to~     measure antibody levels (the proxy of the immune response), before and after the~     vaccinations. A group of unvaccinated women and their babies (50 pairs) will also be~     recruited to allow comparison of their immune responses.~   "
108627|NCT02145611|"~     Cardiovascular disease is a major public health problem in our country. Among the causes of~     cardiovascular diseases are High Blood Pressure (HBP) and Diabetes Mellitus (DM). Type 2~     diabetes (DM2) is associated with a twofold risk of cardiovascular disease, and endothelial~     dysfunction is an early marker of vascular complications. There is evidence of action of~     glucagon-like peptide 1 (GLP-1) on endothelial cells and vascular smooth muscle. Vildagliptin~     is a drug used in the treatment of DM2 able to prolong the activity of GLP-1, improving~     glycemic control and endothelial function.~      Objectives: To evaluate the effect of vildagliptin on endothelial function in patients with~     DM2 and hypertension using the Endo-PAT 2000 device.~   "
108628|NCT02145598|"~     This is a multicenter, randomized, blinded, 2-arm phase IIb trial that will compare the~     efficacy and safety of Lenalidomide maintenance after Bortezomib/Melphalan/Prednison (VMP)~     induction to VMP without maintenance (Placebo). In addition the trial will assess the~     treatment of Revlimid/low dose Dexamethasone (Rd) as Salvage after VMP without sufficient~     response (less than PR) in an observational arm. Key eligibility criteria include patients~     with newly diagnosed multiple myeloma and who are 65 years of age or older or are not~     candidates for high-dose chemotherapy and autologous stem cell transplantation. Patients with~     poor performance status or serious coexistent medical conditions will be excluded from this~     study. After registration all patients receive 6 cycles VMP (modified according to Mateos et~     al.). Patients who receive at least a PR and completed VMP can be randomized to either~     Lenalidomide 10 mg/d continuously maintenance or to placebo. Randomization will be stratified~     according to the quality of response after VMP induction (PR vs. VGPR + stringent complete~     remission [sCR] + CR). Patients that are not able to complete VMP due to toxicity but reached~     at least a PR after a minimum of four cycles of therapy should immediately proceed to~     randomization. Blinded phase continues until progression or end of study. After unblinding,~     patients who received placebo should be treated with Rd.~      Patients that do not reach PR after induction with VMP or are progressive during treatment~     with VMP should not be randomized, but switched to the observation arm and treated with Rd~     immediately. The study treatment ends with the confirmed progression on maintenance treatment~     (Lenalidomide or placebo) for patients that reached PR with induction treatment, or with the~     confirmed progression on second-line therapy with Revlimid® and Dexamethasone for patients~     that did not reach PR on induction treatment. All patients will be followed up every 3 months~     after end of study treatment, until end of study. The study ends two years after Last Patient~     In (i.e. randomization for maintenance) if sufficient events for the primary endpoint were~     received, but not later than 8 years after trial initiation (whatever comes first).~   "
108629|NCT02145585|"~     Closed loop systems for anaesthesia have been shown to be more efficient than manual~     administration and than Target Control Infusion systems (TCI). So far, there is only one~     single-center study demonstrating that a system using simultaneously three closed loops for~     each component of anaesthesia (hypnosis, analgesia and muscle relaxation) is possible, safe~     and is more efficient than manual administration of anaesthetic drugs. Although the results~     of this study are very encouraging, they are limited by its sample of patients recruited for~     non-cardiac surgery only.~      The hypothesis of the present trial is that cardiac anesthesia using a completely automated~     anesthesia delivery system, encompassing each components of anesthesia (hypnosis, analgesia~     and muscle relaxation) is feasible, safe and reliable.~      Thus, the objective of the present trial is to test this pharmacologic anesthesia robot on~     patients scheduled for elective cardiac surgical procedures with extracorporeal circulation.~      Hypnosis is monitored during the surgery according to the brain activity values provided by~     an objective monitoring parameter, called Bispectral Index (BIS).~      A BIS target of 45 is aimed trough the surgery. Performance of propofol hypnosis will be~     determined clinically by recording the % of sedation time during which the actual BIS is~     within 10% of the target BIS (excellent control), within 11 -20% (good control), between~     21-30% (fair control) and beyond 30% of target (inadequate control).~   "
108631|NCT02145559|"~     Given the role of mTOR signaling and probable synergistic activity of combining sirolimus and~     metformin in patients with advanced solid tumors, the investigators hypothesize that:~        1. The combination of metformin plus sirolimus will result in reduction of p4EBP1, p70S6K~          and pAKT more than sirolimus alone in peripheral blood T cells (PBTC).~        2. The combination of metformin plus sirolimus will result in decreased levels of serum~          biomarkers including fasting insulin, C-peptide, glucose, triglycerides, LDH, IGF-1,~          IGF-1R, IGF-BP and leptin, but an increase in adiponectin in peripheral blood.~        3. Expression of active forms of AMPK, mTOR, PI3K, PTEN loss, AKT, LKB1, P62, LC3, and/or~          ULK1 in the tumor tissue (original pathology) will be predictive of response to~          combination therapy. This will be an exploratory hypothesis for this study.~        4. Sirolimus induced toxicity, especially hyperglycemia and hypertriglyceridemia, will be~          mitigated by combining sirolimus with metformin.~        5. Metformin plus sirolimus will have promising anti-cancer activity and this activity will~          correlate with decreases in the above biomarkers. This will be an exploratory hypothesis~          for this study.~   "
108632|NCT02145546|"~     The current evidences indicate that ~30% patients with sick sinus syndrome(SSS) would develop~     persistent atrial fibrillation (AF) after a long term pacing therapy. However, the accurate~     influence of antiarrhythmic drugs on the AF is still not well defined. The purpose of the~     study is to assess the therapeutic effects of various antiarrhythmic drugs (Amiodarone,~     Sotalol and Propafenone) on the long term management of AF in SSS patients with AF, including~     the reduced AF burden (duration and episodes) and persistent AF free survival rate. All~     patients will be followed up for 12 months.~   "
108633|NCT02145533|"~     An association between arterial aneurysms and matrix metalloproteinases (MMPs) has been~     described previously. MMPs regulate extracellular structural proteins and tissue remodeling.~     Neutrophil Gelatinase-associated Lipocalin (NGAL) is involved in the regulation of MMP~     activity. The aim of this work was to study the relationship between the levels of MMPs and~     NGAL and arterial aneurysms.~      In a multicenter, open label, parallel groups, prospective study, patients with aneurysmal~     disease were divided into two groups: Group I (with ruptured aneurysm) and Group II (with~     non-ruptured aneurysm). Healthy volunteer patients were also enrolled and represented the~     control group (Group III).~      The investigators enrolled 307 patients (Group I: 107, Group II: 200) with arterial aneurysm:~     49 popliteal, 31 common femoral, 2 superficial femoral, 29 common iliac artery, 3 common~     carotid and 193 abdominal aorta. Finally, 11 healthy volunteer patients (9 males and 2~     females, age range 40-70 year-old, median 56) were enrolled in Group III.~      Elisa test and Western blot analysis revealed greater levels of immunoreactive MMP-9 and NGAL~     in all patients with ruptured aneurysms, both central and peripheral aneurysms, and in the~     aneurismal vessels.~      These results provide important advances in the understanding of the natural history of~     arterial aneurysms. MMPs and NGAL play a role in development of arterial aneurysms and they~     may represent molecular markers for the prevention of aneurysmal rupture~   "
108634|NCT02145520|"~     In this study, investigators will compare the efficacy and safety of intravenous (IV)~     Magnesium sulfate in decreasing bronchiolitis clinical severity score and the duration of~     hospitalization in admitted patients, as compared to placebo.~   "
108635|NCT02145507|"~     This study will evaluate a new blood collection and filtration system that is intended to be~     used to collect, filter, separate and store red blood cells and, separately, plasma. The new~     blood collection and filtration system will be compared to an already-approved and currently~     used system. Further, this study will evaluate new processing conditions relative to the~     individual components of the collection and filtration system. All study participants will~     donate two units of whole blood with individual units being donated at least 56 days apart.~     One unit of whole blood will be donated with the new system, and the other unit will be~     collected with the already-approved system. A subset of the donors (approximately 24 of the~     120 participants) will have a small quantity of their red blood cells injected back into~     their body 42-days after they were donated in order to evaluate how well the red blood cells~     survive. Blood and blood products from all donors will be analyzed the day of collection and~     after storage (plasma after at least 30 days of storage and red blood cells after exactly 42~     days of storage).~   "
108636|NCT02145494|"~     Giving a higher dose of radiation to the dominant tumour nodule within the prostate is~     hypothesized to improve tumour control. This trial will assess whether this technique,~     delivered in 5 treatments, can be delivered without increasing side effects.~   "
108637|NCT02145481|"~     The objective of the DeQCAD study is to measure the quality of the decision-making process~     for patients with coronary artery disease (CAD) and Acute Coronary Syndrome (ACS) who are~     making treatment decisions. In particular, this study is seeking to answer: a) How informed~     are patients about their treatment choices, b) are patients participating in the~     decision-making process as much as they would like to, and c) do the treatment decisions made~     match patients' preferences?~   "
108638|NCT02145468|"~     Losmapimod is a new anti-inflammatory medication which potentially may benefit patients with~     Acute Coronary Syndrome, (ACS), a condition which includes heart attack. There is a growing~     understanding that the inflammatory response to ACS is integral to the subsequent evolution~     of plaque instability. Losmapimod inhibits p38 mitogen activated protein kinase (MAPK), an~     enzyme which may play a central role in inflammation in the setting of heart attack.~     Inhibition of p38 MAPK may stabilize atherosclerotic plaques, reduce the risk of subsequent~     plaque rupture, indirectly improve vascular function and prevent subsequent thrombosis, and~     thus reduce infarct size and the risk of subsequent cardiac events. This study will test~     whether losmapimod can safely reduce the risk of a subsequent cardiovascular event (such as~     death, heart attack, or near heart attack requiring urgent treatment ) when started~     immediately after ACS (specifically, heart attack). Patients who present with heart attack~     and qualify for the study will be randomly assigned to receive 3 months treatment with either~     losmapimod twice daily or placebo, which will be administered in addition to the usual~     standard of care therapies for heart attack. Following the in-hospital period, subjects will~     return for outpatient visits at 4 and 12 weeks, as well as a follow up visit at 24 weeks.~   "
108639|NCT02145455|"~     This study will compare two different surgical methods used in total knee replacement with~     the Unity Total Knee Replacement System. The study will evaluate these two methods based on~     patients' ability to perform various tasks prior to surgery and at 4 time points during the~     first 12 months after surgery.~   "
108640|NCT02145442|"~     -  Obesity is an important and growing public health worldwide~        -  Obesity is highly related to the development of metabolic syndrome, diabetes,~          cardiovascular diseases and cancer~        -  An extensive body of evidence from efficacy trials has shown that weight loss is~          achievable, however, a modest weight loss is achieved in a small proportion of patients~        -  Important adverse events have been reported with the use of antiobesity drugs.~        -  The use of natural products with potential effects inducing weight loss is an~          alternative strategy for treating patients with overweight and obesity. However,~          efficacy and safety should be evaluated in RCT.~        -  Obex combines different molecules with potential effects inducing weight loss and~          control on metabolic parameters such as fasting glucose, cholesterol and triglycerides.~        -  Therefore, the administration of Obex in overweight and obese patients with impaired~          fasting glucose could be an excellent strategy to induce weight loss and ameliorate the~          metabolic disturbances related to obesity and overweight.~   "
108641|NCT02145429|"~     This study is being conducted in GOA India. The study addresses specific issues of depression~     prevention in older adults living in low- and middle income countries (LMICs), by developing~     risk-reduction strategies through the use of lay health counselors. We will be training Lay~     Health Counselors (LHC's) to deliver simple behaviorally oriented interventions, designed to~     enhance the ability to relax, to improve active coping via better problem solving, and to~     increase protective factors such as good quality sleep. Lay Health Counselors are inhabitants~     of Goa.~      The aim of phase 1 is to create a depression and anxiety prevention intervention for use by~     lay health counselors. We will test the feasibility and acceptability of Problem Solving~     Therapy for Primary Care (PST-PC) and Brief Behavioral Treatment for Insomnia (BBTI). The~     products of phase 1 will be a prevention and counseling manual to standardize the~     implementation of the interventions for further testing in a randomized prevention trial~     (Specific Aim 2) and the adaptation of PST-PC and BBTI for the Indian population.~      In Phase 2, we will: gather data on the feasibility of identifying, enrolling, randomizing~     and retaining participants; implement the experimental intervention and enhanced usual care;~     identify real world, barriers and develop strategies for addressing them; and assess the~     fidelity of the interventions.~   "
108642|NCT02145416|"~     This is a single arm, single centre imaging study which will be offered to all consecutive,~     eligible patients receiving radical chemoradiation therapy (CRT) for anal cancer within~     Oxford University Hospitals.~      Investigations~        -  Dynamic contrast enhanced magnetic resonance imaging (DCE MRI)~        -  Diffusion weighted magnetic resonance imaging (DWI MRI)~        -  MRI scan designed to measure the T1 or produce T1-weighed images (T1 MRI)~        -  MRI scan designed to measure the T2* or produce T2*-weighed images (T2* MRI)~        -  Perfusion computed tomography (pCT)~        -  Fludeoxyglucose positron emission tomography (FDG PET/CT)~      Study Design: Observational~      Target Population: Patients undergoing radical CRT for anal cancer in Oxford University~     Hospitals National Health Service (NHS) Trust.~      Duration on study: Patients should be on study for a maximum of 5 months.~      Patient care post-trial: Follow up as per local standard.~      No. of Study Site(s): Single Centre, United Kingdon (UK)~      End of study: Last Patient, last assessment of response. Patients should be on study for a~     maximum of 5 months.~   "
108643|NCT02145403|"~     The investigators hypothesize that adding carfilzomib to standard conditioning regimen for~     allo-HCT for advanced or high-risk hematologic malignancies will decrease post-transplant~     relapse and treatment-related mortality by decreasing severe GVHD, leading to overall~     improvement in transplant outcomes.~   "
108644|NCT02145390|"~     Bladder preservation in patients with complete response after neoadjuvant chemotherapy will~     lead to equivalent or superior relapse free rates compared to cystectomy rates from~     historical controls.~   "
108645|NCT02145377|"~     To compare the ability of a single dose of PXVX0200 at two different dose levels, to placebo~     to elicit a significant antibody response 14 days after vaccination, compared to baseline.~      To compare the ability of a single dose of PXVX0200 to a comparator vaccine Shanchol, a two~     dose administration, to elicit antibody response by 14 days after vaccination.~   "
108646|NCT02145364|"~     This is a prospective, multi-site trial to be conducted at 2 clinical sites. Up to 20~     subjects will receive study treatments. Following study treatments, follow-up visits will~     occur at 60, 90 and 180 days from each subject's last study treatment.~   "
108647|NCT02145351|"~     Determine the impact of restoring normal heart rate response during exercise and daily~     activity in patients with heart failure and a preserved ejection fraction (HFpEF) and~     chronotropic incompetence (CI).~   "
108648|NCT02145338|"~     This research project is designed to find out whether people who suffer repeated urinary~     tract infections (UTI) related to the need to empty their bladders intermittently with a fine~     plastic tube (catheter); a process called clean intermittent self-catheterisation (CISC),~     benefit from taking continuous daily low-dose antibiotics (antibiotic prophylaxis). The~     investigators estimate that about 40,000 people in the United Kingdom need to use CISC~     regularly to empty their bladder either because of nerve damage such as multiple sclerosis or~     because of failure of the bladder muscle to contract, and of these about 25% (10,000 people)~     suffer frequent UTI. One way to reduce this problem may be to take a small daily dose of~     antibiotics and the study aims to find out whether such treatment is effective and worthwhile~     both for the people who suffer the problem and for the National Health Service (NHS).~      The two options to be compared in the trial are firstly, a once daily preventive dose~     (prophylaxis) of an antibiotic routinely used for this purpose (either nitrofurantoin or~     trimethoprim or cefalexin), and secondly no prophylaxis. The investigators think that an~     overall decrease of 20% or more in the frequency of UTI would be large enough for future~     patients using CISC who get troublesome recurrent UTIs to be offered antibiotic prophylaxis~     routinely. The investigators will also assess any harm caused by continuous use of~     antibiotics, particularly side effects for those people taking them and changes in the~     resistance of bacteria to these antibiotics. The investigators can then work out whether the~     balance between the benefits and harms make the use of prophylaxis worthwhile to people~     carrying out CISC and for the NHS as a whole.~   "
108669|NCT02145065|"~     The purpose of this pivotal, first in man study will be to evaluate safety and efficacy of~     the novel, microcrystalline paclitaxel coated balloon (mcPCB, PAK, Balton) in the treatment~     of femoropopliteal artery disease.~   "
108649|NCT02145325|"~     Regulatory CD4+CD25+ T cells (Treg) derived from the thymus and/or peripheral tissues have~     been demonstrated to broadly control T cell reactivity (14). Importantly, Tregs have been~     shown to control immune responsiveness to alloantigens and significantly contribute to~     operational tolerance in transplantation models (15, 16). However, there have been limited~     efforts to harness the therapeutic potential of directly isolated CD4+CD25+ Treg cells for~     controlling graft rejection and inducing transplantation tolerance, such as for kidney~     transplants. In order for CD4+CD25+ Treg cells to be used as a clinical treatment, the~     following cell properties could be necessary: ex vivo generation of sufficient numbers of~     cells, migration in vivo to sites of antigenic reactivity, ability to suppress rejection in~     an alloantigen-specific manner, and survival/expansion after infusion for a critical, but~     currently unknown, period of time. Our published work and that of other investigators has~     demonstrated 1) the feasibility of expanding Treg ex vivo, 2) the ability of these cells to~     downregulate allogeneic immune responses in vitro, and 3) the efficacy of Treg for prevention~     of allograft rejection in animal models (15,16). We have developed strategies for the ex vivo~     expansion of naturally occurring human Tregs (nTregs) that allow for the practical employment~     of this cellular therapy in the clinic. Our central hypothesis is that sufficient human nTreg~     can be expanded ex vivo and used to both prevent renal transplant rejection and facilitate~     the reduction and subsequent withdrawal of drug-based immunosuppression. This study will~     allow for us to define the safety of Treg adoptive cellular transfer (TRACT) in living donor~     renal transplant recipients that draws upon our extensive preclinical experience with~     expanded Tregs, as well as our recognized clinical expertise with designing immunosuppressive~     regimens compatible with this type of therapeutic cell transfer.~   "
108650|NCT02145312|"~     One promising approach to the treatment of cancer is inhibition or modulating the crucial~     signal transduction pathway of PI3K-Akt-mTOR. Several PI3K inhibitors are being tested in the~     clinical trials for cancer treatment but not for the head and neck cancer yet. BYL719 is an~     alpha specific I PI3K inhibitor. It showed significant, concentration dependent cell growth~     inhibition and induction of apoptosis. We suggest multicenter single arm phase II study to~     determine anti-tumor effects of BYL719 in patients with recurrent and/or metastatic SCCHN who~     failed to prior chemotherapy regimens. Enrollment will be done in 5 or more clinical trial~     centers in Korea. Primary objective is to evaluate disease control rate (DCR) at 8 weeks of~     BYL719, and the efficacy will be evaluated by the investigators analysis based on RECIST~     version 1.1.~   "
108651|NCT02145299|"~     This is a prospective, multicenter, randomized, single-blind study enrolling up to 75~     subjects at up to 5 sites in the US. Eligible subjects with symptomatic femoro-popliteal CTO~     will be randomized 2:1 to treatment with the TruePath™ CTO Device (Intervention) or the~     CROSSER™ CTO device (Control). All patients will receive standard anticoagulation per~     hospital protocol and antiplatelet therapy with aspirin and clopidogrel.~   "
108652|NCT02145286|"~     The purpose of this research study is to evaluate the safety and effectiveness of an~     experimental procedure called Focused Radiation that may result in a faster way to plan and~     deliver radiation for the treatment of pain caused by metastatic bone tumors (cancerous~     tumors that originally came from another organ and have spread to bones). In this trial a~     single fraction of radiation will be given from 8-15 Gray.~   "
108653|NCT02145273|"~     Maternal depression is a pervasive problem that disproportionately affects low-income~     mothers. The effects of depression on mothers and their parenting result in many negative~     outcomes for children, particularly in terms of school readiness. The proposed research will~     build on a successful partnership between the University of Southern California School of~     Social Work (USC) and Children's Institute, Inc. (CII) to implement and evaluate an~     evidence-based intervention, interpersonal psychotherapy for group (IPT-G), for Head Start~     mothers with depression or dysphoric mood with the goal of reducing their depression and~     promoting positive changes for both mothers and children. The objectives of the study are:~     (1) adapt IPT-G for a Head Start population of mothers with depression; (2) implement IPT-G~     via a randomized controlled trial in Head Start centers in Los Angeles County operated by~     CII; (3) evaluate the effects of the intervention on maternal depression, parenting~     behaviors, goal-directed behavior, interpersonal relationships, physical health, and child~     behavior and school readiness; and (4) develop a manual for use of the intervention in Head~     Start and disseminate findings nationally. The study will feature 2 groups of 60 mothers~     each, randomized by Head Start site; one will receive the intervention and the other services~     as usual. Outcomes for both mothers and children will be tracked for 2 years after the~     intervention, allowing for the evaluation of short- and long-term effects. The intervention~     will be delivered by Head Start mental health workers under the supervision of Scott Stuart,~     a national trainer of the intervention. This intervention has the potential to be a low-cost,~     high-impact intervention that can be replicated to other Head Start sites across the country~     to improve the lives of Head Start children and families.~   "
108654|NCT02145260|"~     Intra-dialytic hypotensive (IDH) events can be defined as an abrupt decline in blood pressure~     that cause symptoms and/or require an intervention. They are common, affecting up to one~     third of maintenance HD sessions. Detrimental associations include: development of myocardial~     stunning, cerebral hypo-perfusion, vascular access thrombosis and greater mortality.~      Rapid solute removal by HD generates temporary osmotic gradients between the intra-vascular~     and intra-cellular compartments, promoting trans-cellular fluid movement and resultant~     hypotension. Manipulation of osmotic gradients, e.g. using higher dialysate sodium (DNa), may~     ameliorate excess SBP decline during HD.~      This study aims to assess the effects of higher (142 mmol/L) versus lower (138 mmol/L)~     dialysate sodium (DNa) use in adult chronic hemodialysis patients admitted to hospital on~     intra-dialytic blood pressure and biomarkers of cardiac ischemia.~      The investigators will randomly assign subjects to higher versus lower DNa during their~     hospital stay, up to a maximum of six HD sessions.~   "
108655|NCT02145247|"~     Women with PCOS suffer from excess male hormone (androgen) production by the ovary. Androgen~     is made by cells that surround follicles that contain eggs. As the follicles (and eggs) grow~     and mature, there are more androgen producing cells. Women with PCOS have more follicles than~     normal women and therefore more androgen producing cells. While androgen production has been~     associated with the number of follicles, the relationship to the individual size of follicles~     in PCOS or normal women. This study intends to determine whether the size and number of~     ovarian follicles are correlated to androgen production in PCOS and normal women.~   "
108656|NCT02145234|"~     The purpose of this study is to evaluate the safety, tolerability, immunogenicity,~     pharmacokinetics and pharmacodynamics of single and multiple doses of BMS-986089 in healthy~     adult subjects.~   "
108670|NCT02145052|"~     The primary objective of this study is to identify the optimal method of fascial closure of a~     laparotomy incision in high risk patients for intra-abdominal complications. The~     investigators hypothesize that interrupted closure is associated with decreased complication~     rates when compared with running/continuous closure. Secondary objectives are to determine~     the rate of dehiscence in continuous and interrupted suture technique, and to determine the~     rate of wound infection, hernia formation, and mortality associated with suture technique.~   "
108671|NCT02145039|"~     This is a treatment guideline for HLA-Haploidentical hematopoietic stem cell transplant~     (HSCT) using a reduced intensity conditioning (RIC) regimen. This regimen, consisting of~     fludarabine, cyclophosphamide and low dose total body irradiation (TBI), is designed for the~     treatment of patients with advanced and/or high risk diseases.~   "
108657|NCT02145221|"~     The investigators are studying music therapy as an incentive and adjunct to a comprehensive~     spine surgery rehabilitation-recuperation program. Through the use of music therapy~     psychosocial support is motivated by the clinical use of music. The program will investigate~     the use of music therapy as an option for managing symptoms associated with spine surgery~     recovery. The proposed program will investigate the use of music therapy as an integrative~     treatment within Beth Israel's Department of Spine Surgery.This study will investigate the~     effects of music therapy in managing spine surgery recuperation and to reduce the intensity~     and experience of pain. Outcomes will include: Pain (pain medication dosage and patient~     report) using a CAS Color Analysis Scale and the VAS Pain Rating Scale, level of~     self-reliance/independence using physical therapy assessment scale, cooperation through~     evaluating number of times patient declined/accepted services, length of stay, patient~     satisfaction/patient report, level of kinesiophobia using the Tampa Scale for Kinesiophobia~     and anxiety/depression using the HADS during the period post-spine surgery.(see attached~     scales in Appendix section)~   "
108658|NCT02145208|"~     The study will include an implantation of the TIND device and 4 follow up visits up to 12~     months after the implantation.~   "
108659|NCT02145195|"~     The main purpose of this study is to investigate whether and in which doses vitamin D intake~     is needed in order to maintain an adequate vitamin D status in 4-8 year-old Danish children~     during wintertime.~   "
108660|NCT02145182|"~     The purpose of this study is to determine if Eculizumab is safe and could be used to prevent~     delayed graft function following kidney transplantation.~   "
108661|NCT02145169|"~     To describe the safety and efficacy of nitrous oxide during ketamine administration for the~     prevention of emergence reaction during Emergency Department procedural sedation and~     analgesia in adults. Drugs such as fentanyl, midazolam, and propofol are widely used in~     emergency departments for procedural sedation and analgesia because they have a rapid onset~     and short duration of action. Unfortunately, all of these agents may cause respiratory~     depression, particularly when combined with other sedative agents, administered in large~     doses, or given to patients with underlying respiratory diseases. Nitrous oxide use during~     ketamine administration may be an ideal combination for the prevention of emergence reaction~     in adults sedated in the ED. Like ketamine, nitrous oxide has an excellent cardio-respiratory~     profile as well as some analgesic and anxiolytic qualities. The anxiety and pain surrounding~     procedural sedation is not limited to the procedure itself, but the elapsed time from the~     time the patient enters the ED to the time spent in preparation for the procedure can be~     significant and lead to increased anxiety, which may exacerbate emergence reactions in~     adults. Using nitrous oxide before ketamine administration may mitigate this. While midazolam~     has shown efficacy in reducing emergence reactions in adults sedated with ketamine, the~     investigators believe that inhaled nitrous oxide may be equivalent to midazolam, with a~     better cardio-respiratory profile.~   "
108662|NCT02145156|"~     The purpose of this study is to evaluate an innovative approach to improving HPV vaccination~     among the Hispanic population. The clinical objectives/aims of this HPV educational~     intervention project are to determine:~        1. The number of young adults and adolescents in each arm who received any dose of the HPV~          vaccine during the study period,~        2. The number of young adults and adolescents in each arm who initiated the HPV vaccine~          series during the study period,~        3. The number of young adults and adolescents in each arm who initiated but did not~          complete the HPV vaccine series during the study period,~        4. The number of young adults and adolescents in each arm, among all eligible, who~          completed the HPV vaccine series during the study period,~        5. The number of young adults and adolescents in each arm who completed the HPV vaccine~          series during the study period, among those who initiated the series at study start, and~        6. The number of young adults and adolescents in each arm who completed the HPV vaccine~          series among those who initiated the series during the study period.~      The implementation of this educational intervention in clinic waiting rooms is intended to~     assist primary care providers in communicating HPV vaccine awareness and education to parents~     and patients in a culturally tailored format.~   "
108663|NCT02145143|"~     The purpose of this study is to find out what effects, good and/or bad, a drug called~     vemurafenib, either alone or combined with another treatment called radioactive iodine, has~     on the patient and thyroid cancer. It is not known if vemurafenib works against thyroid~     cancer. This study will test in a small number of patients if it can be used with radioactive~     iodine to treat thyroid cancers. This type of study is called a pilot study. If the results~     are positive, a larger study with more patients may be done to further test this treatment.~   "
108664|NCT02145130|"~     The purpose of this study is the evaluation of the safety of autologous tissue-engineered~     dermal substitutes denovoDerm (first arm) and dermo-epidermal skin substitutes denovoSkin~     (second arm) transplanted onto the wound bed in children and adults.~   "
108665|NCT02145117|"~     This project aims to develop and test structural and functional brain imaging biomarkers for~     improvement in chronic pain from a mind/body intervention perspective in a critical veteran~     population, namely veterans with post traumatic headache (PTH) associated with mild traumatic~     brain injury (TBI). The project also aims to examine feasibility in a sample of veterans with~     PTH of performing resting state and structural neuroimaging protocols, and of obtaining~     active participation and completion of MBSR training. Lastly, exploratory analysis of brain~     imaging data will be performed to determine if hypothesized candidate biomarkers are~     associated with positive outcomes from MBSR and determine estimated effect sizes for future~     studies in PTH population.~   "
108666|NCT02145104|"~     The purpose of this study is to evaluate of efficacy and safety of cilinidipine plus~     valsartan and valsartan alone in patients with essential hypertension inadequately controlled~     on valsartan monotherapy~   "
108667|NCT02145091|"~     This is a double-blind placebo-controlled study investigating the acute and persisting~     effects of psilocybin on meditation, spirituality, health, well-being, prosocial attitudes,~     and brain functioning.~   "
108668|NCT02145078|"~     This pilot clinical trial studies whether the levels of certain genes in the tissue and blood~     are related to how well patients with stage IV non-small cell lung cancer respond to~     chemotherapy. Genes may affect how sensitive or resistant tumors are to chemotherapy.~     Studying the levels of genes related to tumor response before and after chemotherapy may help~     doctors learn whether they can predict how well patients will respond to treatment.~   "
108673|NCT02145013|"~     According to the BCLC guidelines, surgical resection of hepatocellular carcinoma complicating~     cirrhosis is restricted to patients with preserved liver function, single nodule without~     vascular invasion and with hepatic venous gradient below 10 mmHg.~      However, other guideline treatment, especially from eastern countries demonstrated that~     surgical resection is safe and feasible and provides better survival than the treatment~     recommended by the BCLC system for patients with similar stage.~      The primary goal of this study is to assess the impact of HVPG on short and long-term~     outcomes in HCC patients who undergo liver resection.~   "
108674|NCT02145000|"~     The study is a double-blinded, randomized, placebo-controlled, trial with two groups of~     infants receiving vaccine or placebo to assess the efficacy and safety of BRV-PV. Three doses~     of BRV-PV containing ≥ Log10 5.6 FFU/Dose of each serotype G1, G2, G3, G4 and G9 will be~     administered at 4 week intervals between doses. The first administration will occur at 6-8~     weeks of age.~      We hypothesize a difference in vaccine efficacy of three doses of BRV-PV vaccine vs. placebo~     against severe rotavirus gastroenteritis in healthy infants in Niger.~      Active surveillance for gastroenteritis episodes will be conducted throughout the trial.~     Surveillance for adverse events will be carried out among all children from the time of first~     vaccination and 28 days post-Dose 3. Surveillance for all serious adverse events, including~     intussusception and death, will be conducted on all participants until they each reach two~     years of age.~      To assess the effect of prenatal nutrition supplementation on infant immune response to the~     BRV-PV vaccine, study villages in the immunogenicity sub-cohort will be randomized in a 1:1:1~     ratio to provide pregnant women with daily iron-folate, multiple micronutrients or a~     lipid-based nutrition supplement. Infants of participating women, if eligible at 6-8 weeks of~     age, will be randomized in a 1:1 ratio to receive three doses of vaccine or placebo and enter~     the main trial as part of the immunogenicity sub-cohort.~   "
108675|NCT02144987|"~     The purpose of this study is to determine whether Bone Marrow Stem Cell transplantation may~     improve Assisted Reproduction Techniques (ART) outcomes in refractive Asherman's Syndrome or~     Atrophic Endometrium.~   "
108676|NCT02144974|"~     Total pelvic exenteration (TPE) is a rare operation, which is the only possible curative~     intervention to treat central residual or recurrent tumors of the vulvar, vaginal, cervical,~     or uterine malignancies after initial surgery, radiation therapy and chemotherapy. Several~     options for pelvic floor and vaginal reconstruction have been described. The transverse~     musculocutaneous gracilis (TMG) flap has been introduced for breast reconstruction as a free~     flap. The investigators adopted the pedicled TMG flap for reconstruction after TPE.~      Between November 2011 and February 2014, twelve patients underwent TPE and reconstruction~     with unilateral (6 patients) or bilateral (6 patients) pedicled TMG flaps. Five patients had~     vaginal reconstruction with bilateral TMG flaps. The investigators describe the operative~     procedure and the outcome of the operation in these patients.~   "
108677|NCT02144961|"~     The aim of this study is to prospectively evaluate the effect of intra-operative Indocyanine~     green angiography (IGA) on both flap design and rate of post-operative fat necrosis in~     patients undergoing autologous breast reconstruction utilizing the Deep Inferior Epigastric~     Artery Perforator (DIEP) flap.~   "
108678|NCT02144948|"~     This is a pilot study to investigate the effect of e.-coli-nissle as supporting therapy to~     antidiabetic standard care in patients with diabetes mellitus type II~   "
108679|NCT02144935|"~     Patients and families are invited to participate in an online registry and data repository~     specifically for patients with transverse myelitis. Their options are to join the data~     repository only, or participate in a clinical sub study in conjunction with the database~     repository. The data generated in this study will come from surveys, interviews, review of~     medical records, and physical examinations.~      Data from this study will be utilized to guide future clinical trials for children with an~     acute case of Transverse Myelitis. Parents and children separately will fill out an online~     data base with 7 banks of surveys, each bank of survey topics have 7-10 questions. We will~     have both the parent and child fill out at time of symptom onset, and three time points to~     follow, 3, 6, and 12 months post symptom onset.~      A small subset of patients filling out the data registry will be able to travel to 1 of 5~     treating TM centers; Children's Medical Center Dallas, Children's Hospital of Philadelphia,~     Hospital for Sick Children (Toronto, CA), Kennedy Krieger Institute, or Johns Hopkins~     University in Baltimore, MD for a physical examination highlighting recovery from Transverse~     Myelitis.~   "
108680|NCT02144922|"~     Although statins reduce cardiac events in hypertensive patients with cardiovascular risk~     factors, the effect of statins on coronary flow reserve (CFR) has not been examined in such~     patients. The investigators hypothesize that pitavastatin added to standard antihypertensive~     therapy will be superior to placebo in improving CFR in hypertensive patients with~     cardiovascular risk, and try to examine this hypothesis in a double-blind, randomized~     comparison study using Doppler echocardiography.~   "
108681|NCT02144909|"~     The investigators are conducting a feasibility study using a randomized controlled trial~     (RCT) design in which participants will receive the Partners in Care (PIC) diabetes~     self-management intervention and then be randomized to either semi-structured social support~     or a standard follow-up control group. Participants in the support groups will receive a~     culturally-tailored, semi-structured social support program delivered in a community setting~     by trained community peer educators and other health professionals (e.g., pharmacist). The~     investigators believe that the addition of a semi-structured social support component as a~     supplement to an evidence-based diabetes self-management intervention will improve diabetes~     self-care maintenance.~   "
108682|NCT02144896|"~     Endothelial function of the skeletal muscle vasculature declines with advancing age. Although~     aerobic exercise training is commonly prescribed to combat loss of endothelial function in~     the elderly, the rate of compliance to training programs is low. Contrary to aerobic exercise~     training, stretching exercise is widely performed in elderly patients to increase muscle~     flexibility and to prevent muscle atrophy induced by immobilization. However, it remains~     unknown as to whether regular stretching of the calf muscles using ankle dorsiflexion~     splinting improves muscle blood flow. The purpose of the proposed work is to test the~     hypothesis that performance of ankle dorsiflexion splinting improves endothelial function and~     lower leg muscle blood flow in older adults. Ankle dorsiflexion splinting will be performed~     on the randomized leg for 30 minutes, 5 times per week for 4 weeks. Leg vascular measures~     will be performed on the splinted and non-splinted legs prior to and at the end of the 4-week~     intervention.~   "
108686|NCT02144844|"~     The hypotheses were as follows:~      H1. Women at low-moderate risk for APD at T1 (baseline EPDS scores of 5-9) in the cognitive~     behavioral intervention (CBI) group will maintain low-moderate risk status and have~     significantly fewer APD symptoms at T2 and T3 than women at low-moderate risk for APD in the~     (TAU) control group (as measured by percent of participants with EPDS scores <9 at T2 and T3~     and mean score changes).~      H2: Women at high risk for APD at T1 (baseline EPDS scores ≥10) in the CBI group will have a~     significantly greater reduction in APD symptoms at T2 and T3 than women at high risk for APD~     in the TAU control group (as measured by percent of participants with EPDS scores <10 at T2~     and T3 and mean score changes).~   "
108687|NCT02144831|"~     The primary goal of the research is to determine if 10 days of dual anti-platelet treatment~     is as effective as 30 days of similar treatment in the prevention of stroke, myocardial~     ischemia (MI) and death in patients with TIAs and minor stroke.~   "
108688|NCT02144818|"~     During the last decades, owing to the growing tendency of women to delay childbearing plans~     because of career and personal priorities, fertility specialists today are seeing more and~     more women with poor ovarian reserve and with poor ovarian response Controlled ovarian~     hyperstimulation (COH) is considered a important factor in the success of in vitro~     fertilization-embryo transfer (IVF-ET), enabling the recruitment of multiple oocytes and,~     thereby, resulting in more than one embryo. However, owing to the extreme variability in~     ovarian response to COH, in a subgroup of patients with poor ovarian response, this method~     may yield a very small number of follicles After succeeding in maximal recruitment of the~     follicles, the triggering of ovulation is extremely important in order to achieve, as many~     as, mature oocytes.~      Several studies have reported retrieval of more mature oocytes after GnRH agonist triggering~     compared to the number of oocytes retrieved after hCG. Among the possible advantages of GnRH~     agonist for final oocyte maturation is the simultaneous induction of an FSH surge. The role~     of the natural mid-cycle FSH surge is not fully clear. FSH was reported to induce LH receptor~     formation in luteinizing granulosa cells, and to promote oocyte nuclear maturation and~     cumulus expansion .~      Another method described to trigger ovulation is the Dual triggering- GnRH agonist 40 h~     prior to ovum pickup and hCG added 6 h after the first trigger. The dual triggering was~     described as the treatment in cases with recurrent empty follicles.~      The aim of the present study is to evaluate three different methods of ovulation triggering~     in women with poor ovarian response~   "
108689|NCT02144805|"~     The study compares short-term and long-term effects on myometrial thickness in women sutured~     by single- or double-layer technique by closure of cesarean uterine incision. The study is a~     randomized clinically controlled study.~   "
108690|NCT02144792|"~     The major hypothesis explaining drug resistance is overexpression of p-glycoprotein at the~     target lesion. Based on several studies, p-glycoprotein (P-gp) has an important role in~     neurologic diseases, especially in drug resistant epilepsy. But there is no surrogate marker~     that can quantify the expression of P-gp because of the difficulty in measuring substances in~     the neurologic system and the lack of clinical trials. Here, the investigators use a novel~     non-invasive [11C] -verapamil Brain PET and SPAM analytic method as a surrogate marker for~     quantifying the expression of p-glycoprotein.~   "
108691|NCT02144779|"~     This project is evaluating the effect of a standardized communication intervention in the~     pediatric intensive care unit (PICU) on long-term distress of family members of children in~     the PICU for 5 days or longer. The study hypothesis is that intervention families will have~     lower (better) acute stress disorder scores when their child is discharged from the PICU and~     lower (better) post-traumatic stress disorder scores at 3-month follow-up, as compared to the~     control group families. The investigators will recruit 220 families (110 in each of the~     control and intervention groups). Families who are randomized to the intervention group will~     receive routine visits from members of the PACT (palliative care) team at least three~     times/week to address psychosocial needs, keep families informed about their child's health~     status, and offer emotional and instrumental support and resources. Families in the control~     group will receive usual care in the PICU. The intervention will end whenever the child is~     discharged from the PICU, which usually happens within 3 weeks of enrollment. The~     investigators will assess family outcomes at discharge from the PICU and 90 days after study~     enrollment. The investigators will conduct two additional activities to learn more about the~     processes of care for those in both the intervention and control groups. First, during the~     intervention, the investigators will recruit 30 families (15 in each group) and ask~     permission to audio-record the family care conferences to assess communication styles and~     gain greater insight into the differences in practice with or without the participation of~     the intervention team. The investigators will obtain additional consent from participants in~     these family conferences who are not otherwise enrolled in the study. Second, after~     completion of the 3-month follow-up interview, a sub-sample of a different 30 families~     (again, 15 in each group) will be invited to participate in qualitative interviews to debrief~     about their experience in the study and the intervention (for those in that group). This will~     be a one-time interview scheduled within 60 days of recruitment for this part of the project.~   "
108692|NCT02144766|"~     The goal of the present study was to investigate the role of pro-inflammatory cytokines in~     myocardial dysfunction and injury resulting from noncardiac injury in children and whether or~     not anti-inflammatory treatment with caudal block prevents pro-inflammatory~     cytokines-associated myocardial dysfunction and injury following noncardiac surgery.~   "
108693|NCT02144753|"~     The objective of this Phase II trial is to test the NTX-1 Fiber in patients with~     constipation-predominant IBS (IBS-C) and determine if it can reduce symptoms, beneficially~     modify gut microbiota composition, and improve gut milieu in these patients. The~     investigators hypothesis for the Phase II study is that NTX-1 Fiber is better tolerated (i.e~     has less side effects) and is more effective than psyllium (the most commonly used fiber in~     the US) for symptom improvement and is effective in correcting the abnormal colonic milieu in~     those with dysbiosis and low SCFA levels.~   "
108694|NCT02144740|"~     Part 2 of the study will assess the effect of 2g of NWT-03 (an egg-white protein hydrolysate)~     on systolic and diastolic blood pressure and flow-mediated dilation in a crossover designed~     study in healthy adults with mild hypertension.~   "
108695|NCT02144727|"~     In oncological aspect, D1+ lymph node dissection would be enough for early stage gastric~     cancer in advanced gastric cancer (stage IB/IIA/IIB ).~   "
108696|NCT02144714|"~     The purpose of this study is to compare the pharmacokinetics, safety, tolerability, and~     immunogenicity of SB5 and Humira (EU sourced Humira® and US sourced Humira®) in healthy~     subjects.~   "
108697|NCT02144701|"~     This randomized pilot clinical trial studies Lactobacillus rhamnosus GG in reducing incidence~     of graft-versus-host disease in patients who have undergone donor stem cell transplant.~     Lactobacillus rhamnosus GG may be effective at preventing for graft-versus-host disease~     caused by a donor stem cell transplant.~   "
108762|NCT02143856|"~     The purpose of the study is to evaluate the amount of compound present in the blood (relative~     bioavailability) after a single oral administration of GLPG1205 given as a capsule~     formulation in fasted versus fed conditions in male healthy subjects.~      Also, the safety and tolerability of a single oral dose of GLPG1205 given as a capsule~     formulation under fasted and fed conditions will be assessed.~   "
108698|NCT02144688|"~     The purpose of this study is to contribute evidence towards the potential to improve~     cognition in HIV+ individuals experiencing cognitive decline through personalized change in~     antiretroviral (ARV) medication. To that end, following a comprehensive evaluation to~     identify confounding clinical conditions, study participants will undergo a lumbar puncture~     to: (i) measure viral load (at 2 copies/ml); (ii) identify Cerebrospinal Fluid (CSF) genotype~     and tropism; and (iii) measure concentration of antiretroviral agents. When indicated from~     the CSF analysis, a personalized change in ARV will be implemented. Cognition will be~     measured in all at study entry and 6 months later.~   "
108699|NCT02144675|"~     This randomized phase II trial studies how well choline magnesium trisalicylate with~     idarubicin and cytarabine works in treating patients with acute myeloid leukemia. Drugs used~     in chemotherapy, such as choline magnesium trisalicylate, idarubicin, and cytarabine, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. It is not yet know whether choline magnesium trisalicylate and~     combination chemotherapy is more effective than combination chemotherapy alone in treating~     patients with acute myeloid leukemia.~   "
108700|NCT02144662|"~     Primary Objective: To investigate the pretreatment quantitative factors as shown in SD-OCT~     images that correlate with posttreatment VA in patients who underwent intravitreal Lucentis~     (Ranibizumab) for RVO.~      Secondary Objectives: Correlations between posttreatment BCVA and pretreatment factors were~     evaluated, including age, pretreatment BCVA, photoreceptor outer segment (PROS) length,~     central foveal thickness (CFT), outer foveal thickness (OFT), and outer nuclear layer~     thickness (ONLT). The factors influencing posttreatment BCVA were evaluated using multiple~     regression analysis.~      Detailed information on macular morphology, such as the photoreceptor IS/OS junction and ELM,~     can be obtained in SD-OCT. Some OCT studies evaluated other quantitative factors in eye~     disease. It was reported that PROS length was correlated with BCVA in patients with DME.¹~     Other investigators suggested that the thickness, area, and volume of the outer layer were~     correlated with BCVA in patients with dry age-related macular degeneration (AMD).² Outer~     foveal thickness (OFT) and relative reflectivity of the outer nuclear layer (ONL) were~     associated with BCVA in patients with macular hole.3, 4 The volume of the ONL was found to be~     associated with BCVA in patients with AMD.5 The aim of this study was to investigate the~     pretreatment quantitative factors as shown in SD-OCT images that correlate with posttreatment~     VA in patients who underwent intravitreal Lucentis (Ranibizumab) for RVO.~   "
108701|NCT02144649|"~     This randomized pilot clinical trial compares tangerine and red tomato juice in treating~     patients with prostate cancer undergoing surgery. A diet high in lycopene, a substance found~     in tomatoes, may help prevent normal cells from transforming into cancer cells in patients~     with prostate cancer.~   "
108702|NCT02144636|"~     This randomized control trial of diet with protein supplementation is being conducted to test~     the hypothesis that in overweight/obese subjects high protein diet may lead to weight loss~     and improvement in cardio-metabolic profile.~   "
108703|NCT02144623|"~     This trial includes patients with chronic lymphocytic leukemia, the most common kind of~     malignant lymphoma. Monoclonal antibodies directed against cluster of differentiation antigen~     20 have improved treatment results in different forms of lymphomas; however in chronic~     lymphocytic leukemia treatment with monoclonal antibodies is less effective, and it has been~     suggested that this is depending on a lower expression of the cluster of differentiation~     antigen 20 protein on the chronic lymphocytic leukemia cells.~      Valproate, an anticonvulsant drug, has been shown to increase the cluster of differentiation~     antigen 20 expression, and the rationale in this study is that an increasement of cluster of~     differentiation antigen 20 would make treatment with monoclonal antibodies in patients with~     chronic lymphocytic leukemia more effective.~   "
108704|NCT02144610|"~     Study to Evaluate the Efficacy and Safety of AMG0001 in Subjects with Critical Limb Ischemia.~   "
108705|NCT02144597|"~     Losing weight before undergoing Roux-en-Y gastric bypass (RYGB) surgery may reduce liver fat~     content and size thereby improving surgical outcomes. This study aims to investigate whether~     a 2-week or 6-week pre-operative liquid formula low-calorie diet (LCD) reduces liver fat~     further than a conventional food diet prior to RYGB using magnetic resonance imaging (MRI).~     The hypothesis is that the 2-week and 6-week liquid formula LCD will reduce liver fat further~     than the conventional food pre-operative diet.~   "
108706|NCT02144584|"~     This will be a randomized double blind placebo-controlled pilot study using a repeated~     measures design in which participants with acute ischemic stroke and upper extremity weakness~     are randomized to either drug or placebo~   "
108707|NCT02144571|"~     It is known that diet and physical affect a variety of disease-related endpoints and overall~     health status in general. The investigators also know that dietary and PA intervention~     effects are difficult for individuals to maintain. By contrast, the investigators have some~     evidence that group-based and family-centered, multi-component interventions are more~     effective in terms of creating large changes in diet-related outcomes. Using a~     group-randomized, controlled design, the overall goal of this project is to reduce breast~     cancer-related health disparities in a high-risk community, by achieving these Primary~     Aims,to conduct a regionally-based community-designed dietary and physical activity~     behavioral controlled trial among AA women,to test the effectiveness of the~     community-designed, family-based dietary and physical activity behavioral intervention on~     modifying biomarkers of inflammation and to test the effectiveness of the community-designed,~     family-based dietary and physical activity behavioral intervention on decreasing breast~     density~   "
108723|NCT02144363|"~     Mechanical ventilation used to support the sick newborn infant is associated with many~     complications including the development of chronic lung disease. Limiting prolonged invasive~     ventilation remains an important strategy to decrease lung injury and prevent chronic lung~     disease. Currently, there is no objective measure available to predict readiness for removal~     of the endotracheal tube (extubation) and discontinuing mechanical ventilation in this~     fragile population.~      The investigators propose to predict extubation success by evaluating the electrical activity~     of the diaphragm (Edi), which provides important information about the drive to breathing~     coming from the brain and the function of the diaphragm, two essential factors determining~     extubation readiness and success.~   "
108763|NCT02143843|"~     The purpose of this study is to evaluate safety and comfort of the ForSight VISION5 product~     when used for up to 13 months.~   "
108708|NCT02144558|"~     Spinal cord injured (SCI) men, para or tetraplegic, most often have an infertility, caused~     among others by a deficiency of sperm quality particularly motility and vitality. Several~     mechanisms have been proposed: low frequency of ejaculation, recurrent urinary tract and~     seminal infections, presence of an inflammatory syndrome (IS) and an oxidative stress (OS).~     However, no French study of sperm quality has been conducted in this population that could~     identify aggravating factors of sperm quality and a way to prevent them.~      Hypothesis: Sperm parameters decrease rapidly following spinal cord injury and next~     stabilise. However, unidentified yet risk factors could influence long-term evolution of~     sperm parameters.~      The objective is to study the evolution of sperm parameters during 18 months taking into~     account bladder management, recurrent urinary tract and bladder infections, IS and OS. The~     evaluation of these parameters and their consequences will be indicative to determine one or~     more risk factors of sperm degradation and determine a strategy for long term support to~     avoid the use of ART either by sperm cryopreservation and/or by preventing risk factors~   "
108709|NCT02144545|"~     Morbid Obesity (MO) is considered the most important epidemic in the developed world in the~     twenty-first century. After initial assessment of morbidly obese patients and the exclusion~     of potentially correctable causes, management involves a combination of dietary changes,~     cognitive therapy, physical activity, psychological support and pharmacological treatment.~     However, any combination of these factors has proven long-term effectiveness in achieving~     significant and sustained reduction of excess weight. Currently, surgery is the only~     treatment capable of achieving this goal, interacting also with significant improvement in~     quality of life and overall long-term mortality.~      In recent years, several authors have reported excellent short-term results with performing~     sleeve gastrectomy, but whether some aspects regarding the variability of gastric~     tubulization design could influence the results obtained in relation to weight loss and~     functional changes and gastric hormones.~      The main objective of this study is to assess the size of the gastric tubulization (based~     probe calibration and the distance from the pylorus to which initiate gastric section) that~     can provide a better clinical outcome (such as excess weight loss) in patients undergoing~     surgery for morbid obesity. Secondary objectives were to assess the morphological changes,~     physiological and hormonal obtained according to the size of the gastric tubulization and its~     effect on weight loss patients.~   "
108710|NCT02144532|"~     The Ehlers-Danlos syndrome (EDS) is a rare genetic disease caused by an anomaly of the~     connective tissue. This syndrome has different forms. Hypermobility type is the most common.~     It is characterized by generalized joint hypermobility, associated with a chronic pain~     syndrome. Pains appear as the most frequent demonstration of this syndrome, the worst lived~     and the most crippling.~      Faced with insufficient effect of drug treatment, other alternatives have been proposed to~     relieve these patients. Compression garments have been developed. They appear as medical~     devices targeted specifically for patients with hypermobility EDS type: in the symptomatic~     treatment of joint pain, in stabilizing joints by proprioceptive effect and of muscle~     globulization, and in the functional improvement.~      The VETCOSED study is a quasi-experimental study of type Before / After, monocentric, open.~     The study is realized in the Centre Médico-Chirurgical et de Réadaptation des Massues - Croix~     Rouge Française de Lyon, in association with the Pôle Information Médicale Evaluation~     Recherche des Hospices Civils de Lyon. This study concerns about 40 patients with EDS~     hypermobility type, which will be followed for 8 weeks: 4 weeks during which they will wear a~     compression custom-made garment (short-sleeved vest CICATREX SED®), and 4 weeks during which~     they do not carry this garment.~      The main objective is to demonstrate the effectiveness of compression garments in the EDS~     hypermobility type, especially in terms of symptomatic improvement joint pain.~      The main outcomes expected of this study are:~        -  an improvement of the power and the peaks of couple of muscles rotators of shoulders.~        -  a decrease of the pains and the defects of articular stability of the shoulder~        -  an improvement of the quality of life and the functional independence of these patients~   "
108711|NCT02144519|"~     The investigators long-term goal is to advance the adoption and successful implementation of~     policies that promote PA and nutrition in after school programs (ASP) nationwide. The~     investigators objective here is two fold. First, the investigators will test the~     effectiveness of two promising strategies designed to 1) increase the amount of PA children~     accumulate while attending an ASP and 2) promote changes in the nutritional quality of the~     snacks served. This represents a fundamental step in establishing practice-based guidelines~     (best practices) for the uptake and achievement of public health policy goals (CA and~     Harvard). Second, the investigators will examine the barriers and facilitators to~     implementing these strategies. The expected outcome of this study is evidence supporting best~     practices for ASPs to employ to meet policy goals.~   "
108712|NCT02144506|"~     The aim of the pilot-study is to evaluate the feasability of a future RCT, regarding~     recruitement of eligible participants, adhesion rate, datarecording and cost. In this~     feasibility pilot study, 18 patients with at least 65 years will be allocated randomly to one~     of two interventions. The control group gets a well-known home-based exercise program (OTAGO)~     aiming to prevent falls where the exercises are prescribed by a physical therapists. The~     exercises will be presented on a booklet and on printed cards. The Intervention group~     consists of an exercise program, the T&E program, where the elderly persons can choose the~     exercises depending on their abilities. The exercises in the T&E program will be presented~     in a printed manual and shown on videos on an electronic tablet. Both intervention groups~     receive 6 hours of instruction and control/supervision sessions by physical therapists. In~     addition, the participants will exercise alone.~      The interventions will be performed over 24 weeks.~      In this pilot study, the hypothesis is that the adhesion rate is at least 65%. Other~     feasibility criteria will be costs, data recording issues and the qualitative evaluation of~     the booklet and the tablet.~      Falls will be assessed with a falls calendar. The amount of physical activity of the~     participants is assessed with an accelerometers (actigraph) and quality of life will be~     assessed with OPQOL-35 at baseline, week 16 and week 24.~   "
108713|NCT02144493|"~     Recurrent common bile duct stone is one of the risk factors of recurrent cholangitis.~     However, the exact pathophysiology or mechanism of recurrent cholangitis has not been~     established. Periampullary diverticulum and narrow angle of common bile duct have been~     postulated as risk factors of recurrent common bile duct stone. The aim of this study was to~     evaluate the association between periampullary dierticulum, angle of common bile duct and~     recurrent common bile duct stone.~   "
108724|NCT02144350|"~     The investigators aim to prospectively study the feasibility and clinical impact of~     hyperbaric oxygen therapy in acute hospitalized moderate to severe ulcerative colitis flares~     as an adjunct to standard medical treatment. Specifically, we will investigate the impact of~     hyperbaric oxygen therapy on clinical response/remission and serum and mucosal inflammatory~     markers. The investigators expect that hyperbaric oxygen therapy will improve patient~     responsiveness to steroids and avoid progression to second line therapy during~     hospitalization.~   "
108714|NCT02144480|"~     Although the benefit of cardiac rehabilitation following coronary artery bypass graft (CABG)~     is well-established, it is underused. The current investigation will adopt an early,~     intensive, short-term and supervised aerobic training at moderate-intensity. The inclusion~     criteria are diagnosed coronary artery disease (CAD) and clinical indication for elective~     first-time CABG.~      Regular physical exercise is associated with overall reduced risk of primary cardiac arrest.~     Previous study demonstrated that moderate-intensity exercise training reduced resting and~     strenuous exercise-induced activation of platelet and possibly coagulation. Our main research~     question is that whether the short-term CR program in the present investigation will~     ameliorate hemostatic imbalance at rest and platelet coagulation activation at maximal stress~     exercise.~      This is designed to be a prospective randomized controlled study. Sixty men who are scheduled~     to receive elective CABG in Chang Gung Memorial Hospital at Linkuo will be enrolled in the~     study. They will be randomized into two groups: intensive training (IT) and usual~     rehabilitation (UR). Participants in the IT group will receive intensive aerobic training at~     moderate intensity after CABG. A submaximal exercise test will be performed for intensity~     prescription. They will receive two training sessions per day and at least 20 sessions in~     total. The CR group will receive usual CR program. After intervention, each participant will~     receive a maximal exercise test. Additionally, six-minute walk test, generic and~     disease-specific quality of life, will be collected before and after training. Additional 20~     age-matched non-sedentary and healthy men without training will be recruited as control~     group.~      Venous blood will be sampled three times (before and after rehabilitation and maximal stress~     test) for the assessment of platelet activation by flow cytometer and activity of coagulation~     factors. Mean platelet volume, and platelet activation markers (platelet-bound CD62P%G,~     CD63%G, CD40L%G) will be analyzed. Various coagulation and fibrinolysis factors will be~     quantified.~      We hypothesized that this training program will ameliorate the prothrombotic state and~     attenuate platelet reactivity and coagulation induced by strenuous exercise in patients after~     CABG. Hopefully, this clinical investigation will establish an early short-term~     rehabilitation model following CABG and its efficacy for clinical use.~   "
108715|NCT02144467|"~     Aim to establish a large-sample database of Multiple-MRI/Gene/Cognition for healthy Chinese~     (sample number, 5000; age, 6-70 years). This is a fundamental but very necessary work for~     future researches such as development, aging, relation of gene and behavior, relation of gene~     and neuroimaging, relation of behavior and neuroimaging. Importantly, this work will provide~     a norm for researches on psychological or neurological patients. This large-sample will be~     shared with world-wide researchers.~   "
108716|NCT02144454|"~     Cardiovascular disease (CVD) is the leading cause of death in women. Premenopausal women have~     a lower risk of CVD compared with men of a similar age. However, the incidence of CVD~     increases greatly after the menopause. The risk of heart disease is strongly associated with~     the health of an individual's blood vessels. It is thought that changes to the type of fat~     the investigators eat in their diet may affect the normal functioning and elasticity of the~     blood vessels, as well as affect cholesterol levels in the blood. Types of fat in the diet~     include monounsaturated fats (found mainly in olive oil), n-6 polyunsaturated fats (found~     mainly in sunflower oil) and saturated fats (found mainly in dairy products, such as butter~     and cheese). Since the investigators are in the fed (or postprandial) state for up to 18~     hours of the day, it is important to see how these different fats affect the investigators~     blood vessels and blood fats over the course of the day after eating a meal. The aim of this~     study is to determine how consuming meals rich in saturated fats, n-6 polyunsaturated fats or~     monounsaturated fats influence the normal functioning and elasticity of the blood vessels~     throughout the day in postmenopausal women. A secondary aim is to determine the effects of~     these different dietary fats on a range of accepted heart disease risk markers including~     circulating levels of fats (lipids) and glucose in the blood.~   "
108717|NCT02144441|"~     This study will examine the feasibility of implementing a clinician-supported patient~     self-managed inpatient insulin intervention. It will: assess the number of eligible patients~     presenting over time; assess patients' willingness to enroll; assess patients' ability to~     successfully complete the intervention; examine occurrences of hyperglycemia and~     hypoglycemia; and assess patients' satisfaction with inpatient diabetes care.~   "
108718|NCT02144428|"~     The management of children with confirmed cow's milk allergy is based on complete avoidance~     of cow's milk proteins and leaves the physician with several dietary options, none of which,~     given the prevalence, spectrum and potential seriousness of the condition, can be recommended~     to all patients. In the absence of an alternative to cow's milk, the management of cow's milk~     allergy is based on the use of safe, affordable and nutritionally adequate formulas.~     Extensively hydrolyzed cow's milk protein formulas, which are considered as safe for most~     children with cow's milk allergy, are still liable to contain residual peptides, and~     hypersensitivity reactions may occur in infants allergic to cow's milk protein. Thus,~     specific product allergenicity must be addressed on an individual basis before recommending a~     formula as a substitute for cow's milk. Soy-based formula can also concomitant sensitize~     cow's milk allergy children to soy. Amino acid-based formulas have been studied from safety~     and nutritional efficacy perspectives. These formulas have been proposed for subjects highly~     sensitive to cow's milk protein and that cannot be managed using extensively hydolyzed~     formula and for children with multiple food allergies. In these conditions aminoacid based~     formulas are able to effectively cure allergic symptoms and to improve body growth.~   "
108719|NCT02144415|"~     This single-center study will be a single-dose, randomized, double-blind, placebo- and~     active-controlled crossover study with a single inpatient treatment visit. The abuse~     potential of single oral doses of EB-1020 IR (400 mg, 800 mg) will be compared with that of~     placebo and d-amphetamine (20 mg, 40 mg; active control) in healthy recreational stimulant~     users. Subjects will participate in a medical Screening visit (Visit 1), one 4-day inpatient~     Qualification Phase (Visit 2), one 11-day inpatient Treatment Phase (Visit 3), and a safety~     Follow-up visit (Visit 4).~   "
108720|NCT02144402|"~     The primary objective is to determine if the weight gain of healthy term infants fed a~     commercially available term infant formula supplemented with DHASCO® is similar to that of~     infants fed the same formula supplemented with a new product, DHASCO®-B.~   "
108721|NCT02144389|"~     Randomized Controlled Trial:~      The investigational materials used in this trial were administered to subjects each day by~     trained clinicians.~      Primary Objectives:~        -  assess the effect of dietary supplementation with arachidonic acid on the cure rates for~          Schistosomiasis mansoni with and without concomitant treatment with praziquantel.~        -  assess the safety of dietary supplementation using arachidonic acid in children with~          clinically confirmed schistosomiasis mansoni infection.~      Secondary objective:~        -  to measure changes in total phospholipids in plasma.~   "
108722|NCT02144376|"~     The purpose of the study is to test how well magnetic resonance imaging (MRI) can measure~     whole gut transit time in people with constipation, and how readily it can detect a change in~     transit time induced by taking a dietary supplement with laxative effects.The investigators~     expect to demonstrate that ispaghula (psyllium) accelerates movement of matter through the~     intestinal tract.~      The investigators will also assess whether a change in gut bacteria and the chemicals that~     they release can be detected.~   "
108726|NCT02144324|"~     An in vivo study evaluating the efficacy of the Tandem appliance in the treatment of~     maxillary deficiency in growing patients compared to the conventional facemask appliance~     treatment. Pre-treatment and post-treatment lateral cephalograms will be taken. Dentofacial,~     sagittal and vertical skeletal measurements will be taken at three assessment times. Changes~     within each group will be assessed. In addition, the changes between the two groups will be~     compared.~   "
108727|NCT02144311|"~     The purpose of this research study is to learn if differences seen in scans before surgery~     match differences seen when looking at tumor samples with pathology and genetic tests. In~     this study we will use Magnetic Resonance Imaging [MRI] and Positron Emission Tomography~     [PET] scans. No direct clinical benefits will come from the results of this study.~   "
108728|NCT02144298|"~     The aim of this study is to observe the perioperative course of sublingual microcirculatory~     alterations in patients undergoing coronary artery bypass grafting (CABG) using cold blood~     compared with cristalloid cardioplegia. Additionally the impact of changes in hemodynamic~     parameters, blood gas, laboratory findings and standart therapy for intra and early~     postoperative period was studied. Intubation time, ICU stay, hospital stay, ICU readmission,~     morbidity and mortality were recorded.~   "
108729|NCT02144285|"~     The purpose of this study is to look at the tolerability and safety of LY3113593. Study~     doctors will see how safe it is and whether it produces side effects following a single~     injection into a vein or under the skin in healthy participants (Part A) and participants~     with chronic kidney disease treated with hemodialysis (Part B). The study will also measure~     how much of the study drug gets into the blood stream, how long it takes the body to get rid~     of the study drug and what effects the study drug has on the body.~      This is the first time that this study drug is being given to participants. This study is for~     research purposes only and is not intended to treat any medical condition. For each~     participant, the study will last about 85 days, not including screening. Screening is~     required within 28 days prior to the start of the study.~   "
108730|NCT02144272|"~     The main purpose of this study is to learn more about the safety of LY3114062 and to find out~     how well it is tolerated in participants with an inflammatory arthritis. The study will also~     investigate how the body processes the drug and how the drug affects inflammatory arthritis.~     The study is expected to last about 3 months.~   "
108731|NCT02144259|"~     This is a prospective mixed methods study to assess weight changes in women randomized to~     receive Implanon ® or Depo Provera® (DMPA) immediately postpartum compared to women who~     choose non-hormonal contraception or no contraception immediately postpartum. After~     enrollment, subjects return for a visit at 3, 6 and 12 months postpartum to be asked a series~     of questions, take a pregnancy test, and be weighed. Total length of participation for each~     subject is 1 year or until pregnancy.~   "
108732|NCT02144246|"~     Primary Objective Our primary objective in this study is to evaluate satisfaction of hormonal~     contraception in this sample of women and to evaluate the impact that this hormonal~     contraceptive has on cystic fibrosis (CF) disease in women with regular menstrual cycles~     accompanied by cyclic exacerbations.~      We hypothesize:~      1a) women with CF who perceive an overall benefit of hormonal contraception will be more~     satisfied than women with CF who do not perceive a benefit,~      1b) women with CF who have cyclic exacerbations will have decreased Pseudomonas aeruginosa~     mucoidy conversion while using hormonal contraception,~      1c) women with CF who have cyclic exacerbations will have improved patient-reported quality~     of life indices while on hormonal contraception, and~      1d) women with CF who have cyclic exacerbations will have improvement in pulmonary function~     tests while on hormonal contraception.~      Secondary Objective We plan to secondarily evaluate the cervical mucus of women with CF at~     the time of ovulation and compare it to that of healthy controls.~      We hypothesize that women with CF have ovulatory cervical mucus similar to healthy peers.~   "
108733|NCT02144233|"~     The primary endpoint will be the average change in pain score from baseline to the three- and~     six-month assessments. Efficacy will be demonstrated by superior pain relief with the active~     treatment compared with the placebo.~   "
108734|NCT02144220|"~     The primary objective of this study is to evaluate the feasibility, efficacy and the value of~     providing care to individuals with Parkinson disease directly into their homes. The specific~     aims are:~        1. To demonstrate the feasibility of conducting remote evaluations of patients with~          Parkinson disease nationally;~        2. To measure the impact of remote care on each patient's ability to improve his or her~          quality of life (QoL) and better manage his or her Parkinson disease; and~        3. To assess the long-term acceptability to patients in receiving ongoing care remotely via~          telemedicine.~   "
108735|NCT02144207|"~     Some surgical procedures require general anesthesia (i.e., the patient is 'asleep'). When~     under general anesthesia, these patients' airways must be managed to ensure continuous flow~     of oxygen to the lungs, and in most cases, delivery of anesthetic gases to the lungs. Most~     often for airway management under general anesthesia, a plastic breathing tube is placed~     though the voicebox (larynx) into the windpipe (trachea), a process known as tracheal~     intubation. To safely intubate, the larynx must first be exposed. In many cases, this is~     achieved by using a device known as a direct laryngoscope, which is like a curved, lighted~     tongue depressor. It is used to gently move the tongue out of the way, to expose the larynx.~     When the larynx is easily seen, passing the breathing tube is usually also easy.~     Unfortunately, in 2-5% of cases, it is difficult or impossible to view the larynx using the~     direct laryngoscope. This then creates difficulty with tube passage. A number of options~     exist to deal with this situation, including, within the last 10 years, a class of device~     called video laryngoscopes. These devices use a small video chip located towards the end of~     the blade, which, by providing transmission of an image of the larynx 'around the corner' to~     a screen outside the patient, enable a view to be obtained (when no such view could be~     obtained with direct laryngoscope). With the larynx now indirectly visualized, tube passage~     can proceed. However, it's not that easy. When using these 'around the corner'~     videolaryngoscopes, tube passage can be more difficult, as the tube must be guided around a~     90 degree bend from the mouth to the trachea, which sits at right angles to the mouth. Less~     difficulty occurs with tube passage when the direct laryngoscope is used because the blade~     compresses the tongue out of the way, creating a straight line from teeth to the larynx and~     windpipe beyond.~      The GlideScope is one example of video laryngoscope, and has been in use here at CDHA for 10~     years. It has been extensively studied over the ten years, with more than 300 studies~     appearing in the literature. The investigators know from these studies that it is very~     effective at delivering a view of the larynx when direct laryngoscopy has failed to do so.~     However, getting the tube to and through the larynx into the trachea, even with a good view,~     can be problematic. Furthermore, it is the impression of some clinicians that when a~     close-up, full view of the larynx is obtained (as is optimal for direct laryngoscopy) with~     the GlideScope, tube passage appears to be a little more difficult than seems to be the case~     when only a partial view of the larynx is obtained, from a little further away. The~     investigators don't know why this may be so, but may relate to one or more of a number of~     reasons, including (when too close) angling the larynx into an unfavorable angle, or (when~     further away) more favorably reducing the angle between mouth and larynx and trachea.~     However, no guidance on this question appears in the peer-reviewed medical literature, and no~     studies have been done. There is some suggestion in non peer-reviewed internet sites on~     airway management that a partial view may be better, but again, this has not been~     scientifically studied or validated one way or another.~      As mentioned, the GlideScope has been in regular use in CDHA for many years. Most often, it~     is used when difficulty with tracheal intubation is anticipated or has already been~     encountered in the anesthetized patient, although some airway experts suggest that within the~     near future, all intubations will occur with some sort of video laryngoscope.~      It is important to research the present question as in contemporary practice many~     anesthesiologists, faced with a patient in whom they are anticipating difficult direct~     laryngoscopy proceed with putting the patient to sleep, relying on the video laryngoscope to~     enable them to intubate. With a patient now anesthetized and not breathing, if they then have~     trouble intubating the patient in spite of getting a view of the larynx, harm could occur to~     the patient from a failed intubation situation. Furthermore, there are now a number of~     studies documenting that patient morbidity can increase with multiple intubation attempts.~   "
108736|NCT02144194|"~     This 2 arms study will assess the efficacy and safety of the Vinorelbine-Docetaxel~     combination given as an initial upfront treatment (first line) to all metastatic breast~     cancer patients enrolled. Patients having a disease control following initial treatment, will~     be randomized to either oral Vinorelbine maintenance arm or Observation arm. The trial will~     also compare the efficacy and safety of maintenance oral Vinorelbine versus Observation.~   "
108737|NCT02144181|"~     This is a prospective, multi-site (up to 5 sites), single-blinded, randomized trial. Up to 88~     subjects will be enrolled and randomized to one of four treatment groups (4 Groups of 22~     subjects), and will receive study treatments based on their assigned treatment group.~     Following study treatments, follow-up visits will occur at 90, 180 and 365 days from each~     subject's last study treatment.~   "
108738|NCT02144168|"~     Primary objective of this study is to measure the change of concentration of faecal~     bifidobacteria between critically ill patients who receive enteral formula with and without~     prebiotics during enteral nutrition.Our null hypothesis is that there is no difference in the~     concentration of faecal bifidobacteria between critically ill patients who receive enteral~     formula with and without prebiotics during enteral nutrition (EN). Three faecal samples will~     be taken from the patient. First faecal sample is the first stool after initiation of EN and~     second sample is taken seven days after the initial sample and the third faecal sample is~     taken at day 14 after initial sample. Patient will be randomized to receive either of~     described formula after baseline (first) stool sample is obtained. Patient will be monitored~     up to 14 days after the initial stool sample is obtained.~   "
136420|NCT01781598|"~     Description of logistics, learning curve and radiological results in 70 patients treated with~     patient specific instrumentation in total knee arthroplasty as a standard procedure~   "
108740|NCT02144142|"~     Unlike healthy control skin, the skin of patients with atopic dermatitis (AD) is frequently~     colonized by Staphylococcus aureus (S. aureus), putting these patients at increased risk of~     S. aureus skin infections. In addition, research in the investigator's lab has shown that~     these patients have fewer protective Staphylococcal species such as Staphylococcus~     epidermidis (S. epidermidis) that are known to produce antimicrobial peptides that play a~     role in protecting the skin from invading pathogens. In this study, the study team will~     attempt to decrease S. aureus colonization and increase colonization by protective Staph~     species in AD patients by first culturing the bacteria on subjects' lesional AD skin. The~     study team will selectively grow the subject's protective Staph colonies and place them into~     a moisturizer. The first part of the study will determine the half-life of the~     bacteria-containing moisturizer. The bacteria-containing moisturizer will be applied to a~     subject's arm, and the subject will return at four different time points over the next three~     days for skin swabs of the arm that will be used to determine the amount and type of bacteria~     on the arm at those time points. In the second part of the study, the subject will apply~     moisturizer containing his own antimicrobial bacteria to one of his arms for a total of 6~     times at a frequency determined by the half-life, which will be computed at the end of the~     first part of this experiment. The subject will return prior to the 7th application time~     point for skin swabs of the arm to ensure that there are still viable bacteria from the~     moisturizer present on the arm. In the third part of the study, each subject will receive~     both moisturizer as well as moisturizer plus his own antimicrobial bacteria. The subject will~     apply the moisturizer to one arm and the moisturizer plus bacteria to the other arm daily for~     a total of 15 days. Subjects will return to the clinic every 5 days for skin swabs and~     clinical evaluations. If the moisturizer containing bacteria is able to decrease the S.~     aureus colonization on subject's arms, the study team hypothesizes that subjects will have~     improvement of their AD symptoms.~   "
108741|NCT02144129|"~     The purpose of this study is to determine the effect of 12 weeks of WB-EMS either applicated~     passive in a supine resting position or active during slight movements compared with a~     non-training control group on body composition, muscle strength and QoL in patients with~     ulcerative colitis.~      Our main hypothesis is that active WB-EMS application is significantly more favorable to~     address our primary endpoints compared with passive application.~      Our secondary hypothesis is that passive WB-EMS application is significantly more favorable~     to address our primary endpoints compared with non-training control.~   "
108742|NCT02144116|"~     Fibromyalgia is a chronic illness characterized by persistent widespread muscle pain with~     generalized hyperalgesia and allodynia. It can be accompanied by other concomitant symptoms~     like fatigue, sleep disturbances, musculoskeletal disorders, distress and psychological~     disorders. This condition is very prevalent. It has been reported to be about 2-5% of the~     general global population. Fibromyalgia is associated with balance problems and increased~     fall frequency. The objective of this study was to examine the effects of an 8 weeks~     dance-movement therapy programme on balance, strength, flexibility and quality of life in~     patients with fibromyalgia.~   "
108743|NCT02144103|"~     Autologous adipose-derived regenerative cells (ADRC) extracted using Celution 800/CRS System~     (Cytori Therapeutics Inc) from a portion of the fat harvested from the patient's front~     abdominal wall. ADRC will be administered one-time into subtenon space of patient's eyeball.~     This is a single arm study with no control. All patients receive cell therapy.~   "
108744|NCT02144090|"~     The purpose of this study is to assess the usability and safety of the Opsens OptoWire and~     Optomonitor in measuring fractional flow reserve (FFR) in patients with coronary artery~     disease who are undergoing a coronary angiogram.~   "
108745|NCT02144077|"~     The aim of this study is to test the effectiveness and safety of the medicine Ameluz®, used~     with photodynamic therapy (PDT), to treat thin, non-aggressive rodent ulcer.~   "
108746|NCT02144064|"~     Objective To determine maternal and fetal outcomes in women with Unexplained RPL managed with~     aspirin or unfractionated heparin (UFH) plus aspirin during pregnancy.~      Design: prospective clinical controlled study. Setting: high-risk pregnancy unit- Benha~     university hospital. Methods: Pregnant women with unexplained recurrent miscarriage attending~     high-risk pregnancy unit. 200 selected patients with previous unexplained recurrent~     miscarriage are divided into 2 groups: group A (n = 100) receive low-dose aspirin (81 mg once~     daily orally) plus heparin (5000 IU) every 12 h with the ﬁrst positive pregnancy test while~     group B (n = 100) receive no thing .~      Main outcome measures: Maternal outcomes included thromboembolic and haemorrhagic~     complications and pregnancy-induced hypertension .Prematurity, intrauterine growth~     restriction and neonatal death were considered as maternal and fetal complications~   "
108747|NCT02144051|"~     This is a first time in man (FTIM), Phase I study to determine the Maximum Tolerated Dose,~     Recommended Phase 2 Dose, safety, tolerability and Pharmacokinetics of AZD5312. This is a~     multicentre study with sites in the United States and United Kingdom. Approximately 90~     patients are expected to be enrolled in this study.~      The study involves two parts, Part A, Dose Escalation and Part B, Dose Expansion.~   "
108748|NCT02144038|"~     This is a Phase Ib/II study with the primary purpose of the Phase Ib part being to estimate~     the MTD and/or recommended phase 2 dose (RP2D) of the combination of LGH447 and BYL719 when~     administered orally to adult patients with relapsed and refractory multiple myeloma. Once the~     MTD and/or RP2D is determined for the combination of LGH447 and BYL719, additional patients~     will be enrolled in the Phase II part to determine whether the combination of LGH447 and~     BYL719 exhibits improved anti-multiple myeloma activity compared to single agent LGH447.~   "
108749|NCT02144025|"~     Ocular Graft Versus Host Disease (OGVHD) is a serious potential complication of allogeneic~     bone marrow transplants. The usual treatment is topical cyclosporine but when the treatment~     is initiated the damage to the lacrimal glands has already taken place.~      The present study aims to prevent OGVHD in reduced-intensity allogeneic hematopoietic~     transplants by using topical cyclosporine immediately after the engraftment has been achieved~   "
108750|NCT02144012|"~     This is a Phase III, randomized, multicenter, multinational, two-arm, open-label clinical~     trial to investigate a first-line treatment of participants with human epidermal growth~     factor receptor-2 (HER2)-positive metastatic breast cancer. The study will enroll patients~     with HER2-positive, unresectable, locally advanced breast cancer (BC) if they have recurrent~     disease or progressive disease (PD) despite primary multi-modality therapy, and/or metastatic~     BC if they have not received prior chemotherapy for their metastatic disease. Eligible~     participants at up to approximately 40 sites in the Asia-Pacific region will be randomized in~     a 2:1 ratio to receive trastuzumab emtansine (Arm A) or trastuzumab plus docetaxel (Arm B).~     All study drugs will be administered at in-clinic visits occurring every three weeks during~     the treatment phase. Trastuzumab plus docetaxel was chosen as the comparator in the control~     group (Arm B), as it represents a common first-line treatment option used in this patient~     population in China and other Asia-Pacific countries.~   "
108751|NCT02143999|"~     This observational study will evaluate the effectiveness of BRAF inhibitors and current~     therapies in patients with newly diagnosed metastatic melanoma with or without BRAF V600~     mutation. Patients will be treated per the locally approved therapeutic options in clinical~     practice. The observation period for each patient will be up to 24 months.~   "
108752|NCT02143986|"~     In healthy subjects, from 50 to 80 % of the serum ferritin is glycosylated [1, 2] . A~     decrease in the percentage of ferritin glycosylation can be observed in inflammatory~     diseases, malignancies, infections, or liver disease but is rarely less than 20% [3 , 4] .~     Percentage of glycosylated ferritin below 20% have been described in patients with adult~     Still's disease and haemophagocytosis lymphohistiocytic syndromes (HLH).~      The glycosylated ferritin has been included in the diagnostic criteria for Still's disease in~     adults. A cut-off of less than 20 % has a sensitivity and specificity of 72 and 69 %~     respectively , and 35 and 94 % when combined with a total ferritin level greater than 5 times~     normal value. This parameter was also suggested to be a more specific marker to confirm a~     diagnosis of HLH than a high ferritin level ( > 500μg / L). However, several limitations of~     this parameter were highlighted, some conditions making its interpretation difficult :~     particularly in cases of major hepatic cytolysis and severe sepsis (miliary tuberculosis,~     lymphoma and disease Adult Still).~      It is not always possible to distinguish severe sepsis, HLH syndrome and Still's disease.~      A fine analysis of various glycoforms components of ferritin could be used to distinguish~     different subgroups of patients. Few data are available on the mechanism of secretion and~     glycosylation of ferritin, but the investigators assume that the glycosylation patterns of~     ferritin may vary between different disease states and reflect distinct underlying~     pathophysiological mechanisms.~   "
108753|NCT02143973|"~     The primary objective of the study is to evaluate the overall safety of nalbuphine HCL ER~     tablets during a treatment period of up to 24 weeks.~   "
108754|NCT02143960|"~     The purpose of this study is to compare the clinical performance of the VelaShape III device~     with CoolSculpt for reduction of the waist, love handles and flanks.~   "
108755|NCT02143947|"~     The purpose of this study was to determine the effectiveness of two types of in-shoe custom~     made orthotics in altering the motion of the foot and muscle activity of select muscles of~     the lower leg in individuals experiencing lower extremity symptoms of a non traumatic origin.~     We hypothesized that orthotics would decrease the extent of motion of the during walking and~     running when compared to a barefoot condition. The investigators further hypothesized that~     orthotics would decrease the amount of muscle activity seen during walking and running when~     compared to barefoot walking.~   "
108756|NCT02143934|"~     This study specifically seeks to quantify the contribution of relapes to the burden of P.~     vivax infections and disease by determining on the effect of radical pre-erythrocytic and~     erythrocytic clearance on subsequent rates of Plasmodium spp. infection and disease in~     children aged 5-10 years in a treatment to re-infection study design. In order the clear~     liver-stage/blood-stages G6PD-normal children were randomised to receive Chloroquine (3 days,~     standard dose) and Coartem (3 days, standard dose) plus either i) primaquine (20 days,~     0.5mg/kg) or ii) placebo (20days). These drugs were administered over a period of 4 weeks.~      In addition to this epidemiological data, the study will assess the natural acquisition of~     cellular and humoral immune responses to P. falciparum and P. vivax, thus assisting in the~     determination of correlates of clinical immunity to P. falciparum and P. vivax in PNG~     children aged 5-10 years.~      These data will not only be essential for development of future vaccines against P. vivax and~     P falciparum but provide invaluable insight into the contribution of long-lasting~     liver-stages to the force of infection with P. vivax that will contribute towards designing~     more rational approaches to the treatment of P. vivax both in the context of case management~     and future attempts at elimination.~   "
108757|NCT02143921|"~     Alternative, sustainable interventions in support of zinc treatment for childhood diarrhea~     need to be identified. Within the NGO sector, direct provision of health services is~     provided, however some NGOs also work closely with the private sector providers.~     Hypothetically, this avoids unnecessary duplication of effort and enhances the quality of the~     care provided in the private sector. This study will provide objective evidence of the impact~     of this approach, using the scale-up of zinc for the treatment of childhood diarrhoea as a~     test case. The study will be assessing NGO impact among unregulated (unlicensed), rural~     service providers. Further, this study will serve to assess the value of this model of~     scaling up activities in the non-state sector with a particular eye toward more generalizable~     and replicable improvement in quality of care strategies between NGOs and unlicensed private~     providers. This will be controlled before-after (CBA) study. An equivalent control area will~     be included in the study. The objective is to document changes in zinc and antibiotic as well~     as anti-diarrhoeal usage in childhood diarrhea following a scale-up intervention package~     delivered by a local NGO to local private providers. This will include sensitization,~     training and follow-up support. Impact will be assessed in terms of changes in zinc coverage~     and antibiotic use among households in the catchment population served by these providers.~     The study will be conducted in four unions located in Sreepur Upazila within Gazipur~     district, located north to Dhaka. Two of the unions, namely Rajabari and Prohladpur~     comprising 55 villages with 15,530 households and an estimated 76,150 population will serve~     as intervention area. The other two unions Telihat and Barmi will be taken as control sites.~     They contain 53 villages with 19,898 households and an estimated 99,000 population. The~     curative health services in these sites are provided by local drug vendors, village~     practitioners, traditional healers, and licensed government, private or NGO health service~     providers. Data will be collected through survey and in-depth interviews. Data will be~     entered and analyzed using SPSS version 12.0. Absolute counts, proportions, and means with~     95% confidence interval will be calculated. These and regression analysis will be done using~     STATA version 9, cluster survey program, that accounts for potential within cluster~     homogeneity. Based upon the household surveys, the outcomes that will be calculated are:~     coverage-the proportion receiving zinc, ORS (zinc and ORS), and antibiotics or~     antidiarrhoeals and changes in coverage 6 months following the introduction of the~     intervention package, equity: who is receiving zinc by age, gender and socioeconomic status.~     For differences in categorical outcomes crude relative risks and 95% confidence intervals~     will be determined. It is expected that the study will help in increasing zinc coverage for~     the treatment of children under five years of age and decrease in the use of antibiotics and~     antidiarrhoeals within the NGO catchment population.~   "
108758|NCT02143908|"~     Diarrhea as of today is still a major problem in developing world with high morbidity. Though~     mortality in under-5 children has declined over the years, diarrhea was responsible for 2.5~     million deaths per year in developing countries. A median of 3.2 episodes of diarrhea in~     under-5 children per child-year has been estimated in developing countries. In Bangladesh,~     the overall prevalence of diarrhea was estimated to be about 2% for the entire population.~     However, a recent survey in 2003 with urban slum mothers indicated that the prevalence of~     diarrhea ranged from 0.7-4.1% in six divisional cities with 0.7% in Dhaka slum areas.~     Malnutrition remains the major adverse prognostic indicator for diarrhea related morbidity,~     which emphasizes importance of nutrition in early management. Repeated episodes of diarrhea~     are a frequent cause and consequence of malnutrition. To improve diarrhea situation in~     Bangladesh and elsewhere, interventions are directed to reduce mortality and morbidity~     through improvement of breast-feeding practices, complementary feeding, sanitation, increase~     in measles immunization rates, micronutrient supplementation, and oral rehydration therapy.~      L-lysine, an essential amino acid, is required for healthy growth, tissue repair and enzyme~     production. It is a protein-building block that strengthens and nourishes the structural,~     circulatory and immune systems. It is not produced by the body like other essential amino~     acids and must be obtained from the diet. Some natural food sources for L-lysine include Lima~     beans, kidney beans, potatoes, corn, red meat, fish and milk. The mean requirement of lysine~     in healthy human adults is about 30 mg/kg body weight/day or 50 mg/g protein intake. Studies~     have shown that lysine therapy improves immune status and is used as a therapeutic agent in~     herpes simplex viral infection. A double-blind randomized trial of L-lysine treatment found~     it to be an effective agent for significant reduction in occurrence, severity and healing~     time for recurrent herpes simplex viral infection. Lysine fortification increased the blood~     levels of complement 3 (C3), CD-4 and CD-8 T-cells as compared with controls. These two~     studies suggest that supplementation of lysine through food fortification enhances~     immunological status. A few recent studies have also shown an effect of lysine on diarrheal~     incidence and severity. An experimental model suggested inhibitory effect of L-lysine on~     incidence of diarrhea induced by stress and 5-hydroxytryptamine. A community trial among~     adults in Syria showed that the period prevalence and mean duration of diarrheal illness were~     significantly lower in the female participants who consumed lysine-fortified wheat bread~     compared to the control group as well as better immunological parameters such as C3c delta.~      The proposed study will observe the impact of a daily dose of 2000 mg supplemental L-lysine~     for 6 months on diarrheal illness in an adult population of an urban slum area in Dhaka whose~     principal diet is based on cereals such as rice and or wheat. The daily protein and lysine~     availability from diets of Bangladeshi population has been calculated to be about 43g and~     1883 mg respectively, compared to 113g and 7,598 mg respectively in the USA. This means that~     2000 mg daily supplementation of L-lysine would not pose any detrimental effect, as the~     combined usual and supplemental intake will still be substantially lower compared to the~     intake in USA. However, as expected, the supplemental L-lysine may reduce the incidence and~     severity of diarrheal illness through improvement of the nutritional and immunological status~     of the study population.~      The investigators propose to conduct a community-based, double-blind randomized controlled~     trial in Mirpur area of Dhaka city. Adults aged 18 to 45 years residing in the catchment area~     for at least the last six months will be eligible for the study. A total of 440 subjects (220~     females) will be enrolled. The results of the proposed study will contribute to our existing~     knowledge of the effect of lysine on incidence and severity of diarrheal illness as well as~     on immune status. A positive impact of lysine supplementation on diarrheal illness may lead~     to a future strategic approach to the control of diarrhea as a global public health problem.~   "
108759|NCT02143895|"~     Evaluation of the effects of etifoxine versus a benzodiazepine (lorazepam) on vigilance and~     cognitive functions in the elderly.~   "
108760|NCT02143882|"~     The Department of Health has recently announced the implementation of annual vaccination for~     all those aged 18 years and under, with live attenuated influenza vaccine (LAIV), which is~     delivered as a nasal spray. This study seeks primarily to measure antibody responses to the~     LAIV vaccination over three subsequent years and will involve six blood samples, six dried~     blood spots (taken from the end of the blood sample needle) and six oral fluid samples -~     before and three weeks after each vaccination each year. These samples will allow us to~     assess how the immune system responds to the vaccinations in terms of the antibodies that are~     present.~   "
108761|NCT02143869|"~     Denutrition and Obesity are risk factors for perioperative surgical complications.~      In patient with cancer, incidence of denutrition is markedly increased. Surgical resection of~     cancer induces a high intensity cellular stress response and catabolism reinforcing the risk~     for perioperative denutrition.~      In this study, we thought to investigate the change in body composition during the~     perioperative period using anthropometric measurements and Bioelectrical Impedance Analysis~     (BIA).~   "
136466|NCT01781000|"~     The purpose of this study is to reveal the specific effects of computer-aided cognitive~     training on cerebral reorganization in schizophrenia~   "
108764|NCT02143830|"~     The purpose of this study is to determine whether the use of lower doses of busulfan and the~     elimination of cyclosporine will further reduce transplant-related side effects for patients~     with Fanconi Anemia (FA). Patients will undergo a transplant utilizing mis-matched related or~     matched unrelated donors following a preparative regimen of busulfan, fludarabine,~     anti-thymocyte globulin and cyclophosphamide.~   "
108765|NCT02143817|"~     Arterial dysfunction contributes to the development of cardiovascular disease (CVD), which is~     currently afflicting millions of individuals. The use of the amino acid L-citrulline has been~     suggested as a potential aid for the treatment of CVD by increasing endothelial production of~     Nitric Oxide (NO). Whole body vibration (WBV) is new and effective form of exercise that is~     feasible for clinical populations and has been proven to decrease blood pressure (BP) and~     arterial stiffness and increase muscle mass and strength. Therefore, the purpose of this~     study was to investigate if the combination of WBV training (WBVT) plus L-citrulline~     supplementation would induce positive additive effects and would be an effective means to~     ameliorate arterial stiffness, endothelial function, BP and muscle strength/mass in~     postmenopausal women.~   "
108766|NCT02143804|"~     This is an expanded access protocol to study the safety and efficacy of CG0070 in Cis and Cis~     with Ta and/or T1 disease patients who failed both BCG therapy and the BOND protocol (NCT~     01438112), or in high grade Ta and T1 patients who failed BCG therapy.~   "
108767|NCT02143791|"~     The purpose of this study is to confirm long term efficacy and safety of the ProdigyTM~     neuromodulation system in the management of failed back surgery syndrome or chronic~     intractable pain of the trunk and/or limbs.~   "
108768|NCT02143778|"~     This study will be used to train an algorithm using Methacetin breath test (MBT) measures and~     to select a cut-off to determine presence or absence of Clinically Significant Portal~     Hypertension (CSPH) as defined by Hepatic Venous Gradient Pressure (HVPG) ≥ 10mmHg~   "
108769|NCT02143765|"~     Mitiglinide, a benzylsuccinic acid derivative, exerts selective action on the ATP-dependent K~     (KATP) channel of pancreatic β-cells and reportedly possesses a stronger affinity to the~     channel compared with other insulinotropic sulphonylurea receptor ligands, namely repaglinide~     and nateglinide. Preprandial administration of mitiglinide efficiently reduces postprandial~     hyperglycemia and improves overall glycemic control.~      This was a 12-week, open, randomized study for comparing Mitiglinide versus Acarbose. The~     purpose of this study is to evaluate the efficacy and safety of Mitiglinide vs Acarbose in~     patients with type 2 diabetes mellitus.~   "
108770|NCT02143752|"~     The Meriter Smoking Cessation Study tests participants in the Meriter Smoking Cessation~     Program. Meriter Hospital and clinic patients will be recruited into the Meriter Smoking~     Cessation Program. The Meriter Smoking Cessation Program has two interventions, the~     Mindfulness Training for Smokers (MTS) intervention and the Quit Line (QL) Intervention.~     Study activities include one 10-minute study visit and two 5-minute survey phone calls.~   "
108771|NCT02143739|"~     The primary objective of the NIS is to evaluate the severity of newly diagnosed asthma~     patients based on Global Initiative for Asthma (GINA) severity category (GINA 2006 update).~   "
108772|NCT02143726|"~     This randomized phase II trial studies the effects, good and bad, of using everolimus along~     with sorafenib tosylate versus sorafenib tosylate alone in treating patients with advanced~     radioactive iodine refractory thyroid cancer. Sorafenib tosylate and everolimus may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. The addition of~     everolimus to sorafenib tosylate may cause more shrinkage of thyroid cancer and may prevent~     it from growing but it could also cause more side effects than sorafenib tosylate alone. It~     is not yet known whether this treatment with sorafenib tosylate and everolimus is better, the~     same, or worse than sorafenib tosylate alone.~   "
108773|NCT02143713|"~     A randomized study evaluating the continued safety and efficacy of elagolix in the management~     of moderate to severe endometriosis associated pain in adult pre-menopausal female subjects~     who completed 6 months treatment in Study M12-671.~   "
108774|NCT02143700|"~     Chronic obstructive pulmonary disease (COPD) is a chronic condition involving an impairment~     in functionality and in the execution of activities of daily life. The hypothesis of this~     study is to examine the relationship between cognitive status and clinical profile~     (respiratory, sleep quality, nutritional status) in patients with chronic obstructive~     pulmonary disease in two different moments: exacerbation or stable situation.~   "
108775|NCT02143687|"~     The purpose of this study is to investigate the effect of travelling to moderate altitude and~     of nocturnal oxygen therapy during a stay at moderate altitude on exercise performance of~     patients with pulmonary hypertension or with interstitial lung disease.~   "
108776|NCT02143674|"~     Introduction: The life expectancy and the number of people hitting the old age have increased~     in recent years. The aging process is accompanied by morphological and functional changes~     that contribute to reduced functional capacity, increase the number of falls and the~     appearance of physical limitations. Exercise promotes maintenance of functional autonomy,~     improving the physical ability of the elderly making it more independent.~      Objective: To evaluate the effect of a program of muscle strengthening exercises associated~     with global stretching on balance, fear of falling and functional capacity in elderly women.~      Methods: This was a non-randomized controlled trial, in which 12 volunteers aged over 60~     years were divided into two groups: intervention group (IG, n = 7) submitted to muscle~     strengthening exercises and stretching, 2 times per week for 12 weeks, and the control group~     (CG, n = 5), not submitted to the protocol but were educated about physical exercises. Before~     and after the protocol were evaluated scores of Berg Balance Scale, the Falls Efficacy Scale~     International (FES-I) and Evaluation of Functional Autonomy Development Group for Latin~     American Maturity (GDLAM). Data were statistically analyzed within and between groups with a~     significance level of p <0.05.~   "
108795|NCT02143427|"~     The efficacy of the computer based Treatment Program for Children with Aggressive Behaviour~     (Soziales computerunterstütztes Training für Kinder mit aggressivem Verhalten, ScouT) which~     is a child focused social competence training delivered in an individual format will be~     evaluated in a randomized controlled trial with children aged 6 to 12 years with peer-related~     aggressive behaviour.~   "
112429|NCT02095860|"~     The purpose of this study is to assess the effect of a high fat meal and light meal on the~     blood levels of Daclatasvir, Asunaprevir and BMS-791325 after administration of the 3 drugs~     as a fixed-dose combination in healthy subjects.~   "
108777|NCT02143661|"~     The purpose of this prospective observational study is to investigate if mechanically~     ventilated patients who are treated in one of the new intensive care unit (ICU) rooms have~     less delirium compared to patients who are treated in the conventional rooms on the same ICU.~     The investigators will further evaluate the impact on sleep quality, circadian rhythm, global~     cognitive function and general outcome parameters.~      The investigators recorded light and noise conditions in the ICU rooms before start of the~     redesigning process (subproject light and noise in the intensive care unit (LiNo-ICU)). The~     investigators will compare data regarding light and noise in the ICU rooms before and after~     the redesigning process (non-patient related data; ethical vote amendment 08.05.2014).~   "
108778|NCT02143648|"~     The primary objectives of the study to evaluate the effects of two doses of nalbuphine HCl ER~     tablets on the change from baseline in the worst itch Numerical Rating Scale (NRS) in~     hemodialysis patients with moderate to severe uremic pruritus and to evaluate the safety and~     tolerability in the study population.~   "
108779|NCT02143635|"~     To determine and evaluate a safe and tolerated dose of HDM201 in adult patients with selected~     advanced tumors characterized by wild-type TP53.~   "
108780|NCT02143622|"~     To establish whether LJM716 in combination with cetuximab is safe and has beneficial effects~     in patients with platinum-pretreated recurrent/metastatic head and neck squamous cell~     carcinoma.~   "
108781|NCT02143609|"~     The purpose of this study is to investigate the effect of nocturnal oxygen therapy during a~     stay at moderate altitude on exercise performance of patients with chronic obstructive lung~     disease.~   "
108782|NCT02143596|"~     The investigators studied laboratory measurements and previously identified risk factors to~     identify factors predictors of early deterioration following stroke. A prospective~     observational study of 196 patients with first-time acute ischemic stroke was performed.~     Following multivariate analysis, only a Bun/Cr >15 was independent predictor of SIE. These~     patients were 3.41-fold more likely to have SIE (P=0.008). The elevated Bun/Cr ratio~     indicates relative dehydration of the patients. An immediate intervention for such patients~     should be the maintenance of proper hydration.~   "
108783|NCT02143583|"~     Study aiming to evaluate the efficacy of a 2-month pre-seasonal treatment with an AllerT 50~     µg or 100 µg maintenance dose administered in previous study AN004T in reducing symptoms of~     allergic rhinoconjunctivitis during the 2nd following birch pollen season.~   "
108784|NCT02143570|"~     Overactive bladder is a common problem among adult women. Darifenacin is an antimuscarinic~     drug that is frequently used as part of the management of the condition. However, current~     evidence backing its use is limited. This study aims to address Darifenacin's effectiveness~     in adjunct to physiotherapy in treating symptoms due to overactive bladder.~   "
108785|NCT02143557|"~     Chylothorax occurs in ~3 to 5 % of infants undergoing cardiac surgery. Standard treatment~     requires discontinuation of breast milk feeding, due to the abundance of long chain~     triglycerides, and transition to a medium chain triglyceride (MCT) based formula. Objective:~     To determine the effectiveness of fat-modified breast milk (MBM) for the treatment of~     chylothorax compared with MCT-formula. Hypothesis: The investigators primary hypothesis was~     that infants fed MBM would have more chyle drainage in the first 5 days after diagnosis~     compared to infants fed an MCT based formula which is the current standard of care. Design:~     Infants with chylothorax were eligible. Treatment infants (n=8) received mother's own milk~     that had been modified by removing the fat layer via centrifugation and adding MCT and~     nutrients to provide 67 kcal/mL and 11 g/100 mL protein (MBM group). Control infants (n=8)~     received an MCT-formula (MCT group). The feeding intervention was a minimum of 6 weeks after~     chest tube removal per The Hospital for Sick Children standard chylothorax treatment~     protocol. Outcome measures collected included chyle drainage from chest tubes, weight, length~     and head circumference measurements and estimated energy and nutrient intake.~   "
108786|NCT02143544|"~     The hypothesis of the study is to evaluate if the preoperative placement of IABP reduces~     clinical complications in high-risk patients undergoing cardiac surgery.~   "
108787|NCT02143531|"~     This study aims to prove that at a dose of 1 mg Haloperidol possesses a high success rate in~     controlling established postoperative nausea and vomiting (PONV) in the first 24 hours~     following administration similar to the standard of care ondansetron 4 mg.~   "
108788|NCT02143518|"~     Na-GST-1 is a protein expressed during the adult stage of the hookworm life cycle that is~     thought to play a role in the parasite's degradation of host hemoglobin for use as an energy~     source. Vaccination with recombinant GST-1 has protected dogs and hamsters from infection in~     challenge studies. This study will evaluate the safety and immunogenicity of two formulations~     of Na-GST-1 in healthy adult volunteers when co-administered with the immunostimulant CpG~     10104, a Toll-like Receptor-9 agonist.~   "
108789|NCT02143505|"~     Calcium plus vitamin D may be effective in the prevention of colorectal adenoma recurrence.~     The aim of this study is to investigate the effect of supplementation with calcium plus~     vitamin D on the recurrence of colorectal adenomas.~   "
108790|NCT02143492|"~     Standard treatment for kidney cancer is to remove the tumors from the body with surgery. The~     purpose of this clinical trial is to collect, preserve, and store excess kidney cancer tumor~     specimens that would normally be discarded after surgery.~   "
108791|NCT02143479|"~     A study in which two groups of patients will be analysed; patients converted from Prograf to~     Advagraf within the first 3 months after transplantation and patients converted from Prograf~     to Advagraf between 3 months and 1 year after transplantation.~   "
108792|NCT02143466|"~     The purpose of this study is to determine the safety, tolerability and preliminary~     anti-tumour activity of AZD9291 when given together with AZD6094 or selumetinib in patients~     with EGFR mutation positive advanced lung cancer.~   "
108793|NCT02143453|"~     Exercise is an effective strategy to manage juvenile obesity; however this ideal exercise~     training mode is still unclear. In this study, the investigators compared the health-related~     effects of high intensity interval training versus endurance training in obese children.~   "
108794|NCT02143440|"~     To investigate the daily dose of insulin in newly diagnosed Chinese type 2 diabetic patients~     who use the continuous subcutaneous insulin infusion (CSII) as the initial therapy.~   "
112430|NCT02095847|"~     The goal of this clinical research study is to learn if imaging (called a hysteroscopy) can~     be used to help guide tumor removal during a hysterectomy.~   "
108796|NCT02143414|"~     This phase II trial studies the side effects and how well blinatumomab and combination~     chemotherapy or dasatinib, prednisone, and blinatumomab work in treating older patients with~     acute lymphoblastic leukemia. Monoclonal antibodies, such as blinatumomab, find cancer cells~     and help kill them. Drugs used in chemotherapy, such as prednisone, vincristine sulfate,~     methotrexate, and mercaptopurine, work in different ways to stop the growth of cancer cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth. Giving blinatumomab with combination chemotherapy or dasatinib and~     prednisone may kill more cancer cells.~   "
108797|NCT02143401|"~     This phase I trial studies the side effects and the best dose of navitoclax when given~     together with sorafenib tosylate in treating patients with solid tumors that have returned~     (relapsed) or do not respond to treatment (refractory). Navitoclax and sorafenib tosylate may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
108798|NCT02143388|"~     This is an randomized controlled, multicenter clinical trial. The purpose of this study is to~     evaluate acute toxicity and efficacy of concurrent cisplatin chemoradiation with or without~     capecitabine as adjuvant chemotherapy in local advanced high risk nasopharyngeal carcinoma.~   "
108799|NCT02143375|"~     Physiologic gingival pigmentation(PGP) is the most common type of gingival pigmentation and~     cosmetic concern particularly in gummy smile patients. Laser therapy is an effective and~     noninvasive treatment option. The aim of this study was to evaluate the efficacy of diod~     laser on the treatment of PGP in patients.~   "
108800|NCT02143362|"~     The study designed to explore the efficacy and safety of the closed loop of target controlled~     infusion dexmedetomidine combined with propofol for anesthesia with intraoperative wake up.~   "
108801|NCT02143349|"~     Coleus forskohlii extract contains the bioactive compound, forskolin. Preliminary studies~     have shown that forskolin can increase fat metabolism thus reduce fat accumulation in both~     animals and humans. It has been suggested that forskolin may also suppress appetite thus~     reduce energy intake and results in weight loss. This study will evaluate the appetite~     suppressant properties of Coleus forskohlii extract. In addition the effect on central~     obesity and risk factors of metabolic syndrome will also be investigated.~   "
108802|NCT02143336|"~     A comparison of skin closure techniques (standard skin closure with staples versus a~     continuous (subcuticular) absorbable suture), to determine if this changes the rate of post~     operative wound infections in elective colorectal surgery patients.~   "
108803|NCT02143323|"~     This study has an open-label, one-sequence, multiple drug administration design. The purpose~     of this study is as follows;~        -  To evaluate the change of liver function according to glutathione s-transferase (GST)~          genotype after the multiple administration of amoxicillin/clavulanate.~        -  To evaluate the intrinsic metabolite, human leukocyte antigen (HLA) genotype, and~          microRNA (miRNA) based on liver function change as the candidate biomarker for DILI.~   "
108804|NCT02143310|"~     Electronic Vapour Products (EVPs) is a relatively new class of consumer products that are~     otherwise known as electronic cigarettes devices/systems. These may look like conventional~     cigarettes but do not contain tobacco.~      The 'vapour' produced by such devices typically consists of humectants (propylene glycol or~     glycerol), nicotine, water, and flavours.~      This trial is to evaluate the safety and tolerability of an e-vapour product over two years.~   "
108805|NCT02143297|"~     The sleep apnea hypopnea syndrome (SAHS) is a respiratory disorder characterized by frequent~     breathing cessations (apneas) or partial collapses (hypopneas) during sleep. These~     respiratory events lead to deep oxygen desaturations, blood pressure and heart rate acute~     changes, increased sympathetic activity and cortical arousals. The gold standard method for~     SAHS diagnosis is in-hospital, technician-attended overnight polysomnography (PSG). However,~     this methodology is labor-intensive, expensive and time-consuming, which has led to large~     waiting lists, delaying diagnosis and treatment. Blood oxygen saturation (SpO2) from~     nocturnal pulse oximetry (NPO) provides relevant information to detect apneas, it can be~     easily recorded ambulatory and it is less expensive and highly reliable. The investigators~     hypothesize that an automatic analysis of single oximetric recordings at home could provide~     essential information on the diagnosis of SAHS. The aim of this study is two-fold: firstly,~     the research focuses on assessing the reliability and usefulness of NPO carried out at~     patient's home in the context of SAHS detection and, secondly, the study aims at assessing~     the performance of an automatic regression model of the AHI by means of neural networks using~     information from NPO recordings. To achieve this goal, both PSG and NPO studies are carried~     out. A polysomnography equipment (E-Series, Compumedics) is used for standard in-hospital PSG~     studies, whereas a portable pulseoximeter (WristOX2 3150, Nonin) is used for ambulatory NPO.~     NPO is carried out the day immediately before or after the PSG at patient's home. Patients~     are assigned to carry out the NPO study before or after the in-hospital PSG randomly. In~     addition, in-hospital attended oximetry is also performed simultaneously to the PSG using the~     portable pulseoximeter.~   "
108806|NCT02143284|"~     EndoChoice's FUSE System enables a wider view range via 1-2 additional cameras (depending on~     the model). These optical properties are to be examined and reviewed in this trial (mainly~     usability and safety)~   "
108807|NCT02143271|"~     This study is designed to evaluate safety, pharmacokinetics and pharmacodynamics after single~     administration of KHK7580 for secondary hyperparathyroidism in patients receiving peritoneal~     dialysis.~   "
108816|NCT02143154|"~     While it is clear that intrapartum antibiotics reduce neonatal GBS infection rates, the~     mechanism by which these drugs prevent neonatal GBS is not well established. One postulated~     theory is antibiotics work to reduce bacterial load in the birth canal; thus decreasing fetal~     exposure during labor and delivery. To our knowledge, the relationship between vancomycin and~     vaginal GBS colony counts has never been studied. In this prospective cohort study, our~     objective is to determine the relationship between intrapartum IV vancomycin and vaginal GBS~     colony counts.~   "
108817|NCT02143141|"~     The investigators are attempting to see if eliminating the amount of long acting spinal~     narcotic during cesarean section delivery will demonstrate pain scores with movement when~     evaluated 24 hours postoperatively as those that receive the standard dosage of spinal~     narcotic when combined with oral acetaminophen or placebo. The investigators also are~     evaluating if there are decreased side effects related to decreased narcotic usage.~   "
108808|NCT02143258|"~     Increased Intracranial Hypertension (IIH), also known as Pseudotumor Cerebri, is defined by~     increased cerebral spinal fluid (CSF) pressure in the absence of intracranial, metabolic,~     toxic or hormonal causes of intracranial hypertension. It is characterized by headaches,~     tinnitus and visual loss, due to optic atrophy, in 50% of cases. Surgical treatments, such as~     CSF shunt placement and optic nerve sheath fenestration (ONSF), are indicated in case of~     failure or non-compliance (owing to side effects) of medical treatments (that mainly includes~     weight loss and drugs, such as Carbonic Anhydrase Inhibitors). However, these surgical~     treatments are limited by relative high complications and recurrence rate. Indeed,~     improvement in visual function after ONSF is often transient and the risk of complications,~     including visual loss, pupillary dysfunction, and vascular complications is up to 40%. With~     no better treatment option, intraventricular or lumbar shunt placement has become the~     traditional treatment for medically refractory IIH, despite poor results. Indeed, series of~     patients with IIH treated with shunt replacement report a complications rate (shunt~     occlusion, disconnection, infection or intracranial hematoma formation) around 50% and a~     failure rate up to 64% within 6 months. As a consequence, shunt revision is often required~     and efficacy of the technique to control the disease is questionable.~      The role of intracranial transverse sinus stenosis in IIH has recently gained a particular~     interest. Despite the fact that transverse sinus stenosis in IIH may be due to increased~     intracranial pressure, some authors believe that the rise in intracranial pressure and its~     effect are worsened by the secondary appearance of the venous sinus stenosis. To date, very~     few complications have been reported in IIH patients with venous sinus stent placement.~   "
108809|NCT02143245|"~     The purpose of this study is to determine the efficacy of retrieving tissue samples via an~     x-ray guided needle that is inserted into the infected tissue in the shoulder. The procedure~     using the guided needle is called a synovial biopsy versus an open tissue biopsy, which is~     done at the time of surgery. By doing the synovial biopsy prior to a revision surgery, the~     investigators hope to avoid more invasive intervention if it is not needed. Some patients may~     appear to have an infection but once the biopsy is taken and the results are read, there may~     not be an infection and therefore no need for a revision surgery.~   "
108810|NCT02143232|"~     The investigators propose to deploy an interactive device to monitor the patient's recovery~     and vital signs at home after joint replacements. These will be early discharge patients on~     the same day or the next morning. The goal will be to support early discharges by creating a~     safe, controlled, and monitored environment at home.~   "
108811|NCT02143219|"~     Metastatic pancreatic carcinomas represent the 5th cause of cancer death in France (#8000 per~     year). The median age at diagnosis is 69 and 74 in male and female respectively. When the~     5-Fluorouracile has been used as a single agent with a limited efficacy during more than 20~     years, the onset of gemcitabine in 1995 has led to a moderate increase of median survival~     (from 4.41 to 5.65 months) and overall survival at 1 year (2 versus 18%). Recently, in a~     phase II followed by a phase-III study, a French collaborative group has demonstrated the~     benefit of FOLFIRINOX  regimen versus gemcitabine alone, in terms of median survival (11.1~     versus 6.8 months), progression-free survival (6.4 versus 3.3 months) and response rate (31.6~     versus 9.4%).~      Although more hematologic (neutropenia) and GI toxicities were observed, FOLFIRINOX was~     acceptable as a new standard regimen for the majority of patients under the age of 70 with a~     good Performans Status. To reduce the toxicity of FOLFIRINOX in elderly patients (> 70 yo),~     pharmacogenetic monitoring of 5-FU and Irinotecan key metabolism enzymes (DPD and UGTA1) may~     be easily performed. The methodology of the study is to use the Bryant & Day statistical~     method, allowing to consider simultaneously as principal objective, the response rate~     (efficacy) and the tolerance (preservation of autonomy daily living, Katz index): this design~     is particularly fitting in a study for elderly patients who represent half of the pancreatic~     carcinoma population.~   "
108812|NCT02143206|"~     This study will test whether using the Biodex BioStep Semi Recumbent Elliptical for the~     chronic obstructive pulmonary disease (COPD) patient with arthritic limitations will improve~     participation in a pulmonary rehab program compared to the Nustep elliptical. The main~     outcome of participation will be measured by the number of exercise sessions the patient is~     able to complete during their pulmonary rehabilitation program. In addition, distance walked~     in six minutes, dyspnea score, rate of perceived exertion (RPE) score, Pain Scale Index~     score, and finally, the Dartmouth Quality of Life index (DQL) will be assessed in both~     groups. It is believed that the new machine will provide better overall outcomes compared to~     the traditional machine.~   "
108813|NCT02143193|"~     This study will compare standard methods of stabilizing a newborn's temperature after birth~     with mother-infant skin-to-skin contact for stabilizing newborn temperature. The study will~     look at the effects of each warming method on the timing of newborns' initial bath and the~     effects on newborn initiation and percent weight loss by discharge.~      The study will use a randomized controlled trial (RCT) design to test a clinical intervention~     at TriHealth Good Samaritan Hospital. Study participants will be randomized to the~     intervention group (IG), which will implement mother-baby Skin-to-Skin (STS) immediately~     after vaginal birth, or to the control group (CG), which will receive standard care for~     newborn and mother immediately after vaginal birth.~      This study will test the hypothesis that mother-baby STS contact implemented immediately~     after delivery for a minimum of the newborn's first 60 minutes and with a resumption of STS~     (if a 15-minute break in STS occurs at some point after the first hour) until the newborn's~     temperature stabilizes after the initial bath will result in:~        1. Improved newborn temperature stability and thermoregulation for newborns whether breast~          or formula-fed.~        2. Initiation of effective breastfeeding behavior within 90 minutes of birth and the~          addition of at least one more breastfeeding within four hours of birth for breastfed~          newborns.~        3. Avoidance of newborn weight loss of 10% or greater.~   "
108814|NCT02143180|"~     Our study is a prospective multicenter research and the aim is to explore a variety of~     suitable evaluation indicators and criteria for diagnosis of diffuse liver fibrosis, to get~     the corresponding diagnosis threshold, with the domestic common pathological S stages as the~     gold standard.~   "
108815|NCT02143167|"~     Prolonged-release fampridine (SR-fampridine) can improving walking capacity in approximately~     40% of MS patients suffering from this by overcoming partly or total conduction block due to~     demyelination.~      Resistance training has been shown to provide the same kind of benefits for patients by~     targeting the muscular component of the motor unit. Thus by combining the two it is likely to~     see an synergistic effect.~      This trial is designed as a double blind, randomized placebo controlled trial with subsequent~     cross-over.~      Participants in the two arms will go through the same progressive training program targets at~     the lower limbs. For 24 weeks one group receives SR-fampridine and the other receives~     placebo. in the the end there is another four weeks of training after cross-over has been~     performed.~   "
108818|NCT02143128|"~     Using clinical experience and brain storm method the investigators picked up and~     digitalized information about mental, postoperative nausea, vomiting and pain status at the~     rest and during mobilization in so called Efficacy Side-effect Score (ESS) Depending on~     expression of patient's complaints, all mentioned above clinical features are scored up from~     0 to 10-15 and summarized in the total score. This score is now to be validated and~     re-developed to be used as a tool for improving safety and quality of postoperative care.~   "
108819|NCT02143115|"~     The goal of this study is to compare the findings of virtual (CT-colonography) with findings~     of optical colonoscopies to determine if virtual colonoscopy is suitable for colorectal~     cancer surveillance.~   "
108820|NCT02143102|"~     The investigators use MRI and/or CT to evaluate the extent, as well as, the structure,~     composition, and functional aspects of atherosclerotic plaques in human carotid and femoral~     arteries in patients scheduled to undergo an endarterectomy of the aforementioned vascular~     beds as part of their routine clinical care.~   "
108821|NCT02143089|"~     Use versus non use of urinary catheterization during Second Elective caesarean delivery:~   "
108822|NCT02143076|"~     Youth diagnosed with sickle cell disease (SCD) may have difficulty taking medication as~     prescribed (adherence). Hydroxyurea (HU) is one medication that youth may take to help manage~     SCD. Electronic adherence monitoring is widely considered the gold standard in objective~     adherence measurement. These monitors provide continuous, real-time records of medication~     adherence and reveal problematic behavior patterns, including underdosing, overdosing,~     delayed dosing, drug holidays (i.e. where individuals do not take medications for a~     specified interval of time), and white coat adherence (i.e., a pattern of drug adherence as~     a function of time where individuals display good adherence immediately before and after~     clinic attendance with worsening adherence in the period between).~      Overall, electronic adherence measures are considered valid, reliable, and accurate, with~     clear advantages over pharmacy refill records, physician estimates and self-report measures.~     Currently, only one electronic measure capable of monitoring medications in both pill and~     liquid form is being manufactured: WisePill and WiseBag. While data are limited regarding its~     validity and reliability, preliminary data support the use of Wise technology to measure~     adherence to medication. The current study will determine the Wise device's ability to~     feasibly measure adherence to liquid and solid form HU medication in a pediatric SCD~     population.~   "
108823|NCT02143063|"~     Reinforcement interventions have pronounced effects on reducing cocaine use. This study will~     evaluate a novel approach in which reinforcement frequency varies by patient performance. To~     test efficacy, 280 patients with cocaine use disorder will be randomly assigned to: standard~     care, standard care plus traditional twice weekly reinforcement, or standard care plus~     adaptive variable interval reinforcement.~   "
108824|NCT02143050|"~     The main purpose is to evaluate the clinical response, safety and survival of the FDA~     approved drugs Dabrafenib, Trametinib in combination with Metformin. Investigators~     hypothesize that the combination of an FDA approved non toxic dose of oral Metformin with the~     B-Raf inhibitor, Dabrafenib and the MEK inhibitor, Trametinib will yield little toxicity and~     improve clinical outcomes in terms of objective response rates and survival in metastatic~     melanoma patients.~   "
108825|NCT02143037|"~     Contingency management (CM) is highly efficacious for reducing substance use, and recent data~     suggest that reinforcing attendance at treatment can significantly improve treatment~     outcomes. Importantly, CM interventions that reinforce attendance are more likely to be~     adopted clinically than those that reinforce abstinence. Having objective indicators of~     drinking outcomes, nevertheless, is critical for quantifying the benefits of attendance-based~     CM treatment in alcohol abusing populations. New technology is now available to gauge alcohol~     use in patients' natural environments. The Secure Continuous Remote Alcohol Monitor (SCRAMx®)~     continuously monitors alcohol consumption 24 hours a day. As such, it may be ideal for~     objective evaluation of alcohol consumption during treatment intervention studies, including~     those that involve CM.~      In this study, 114 patients participating in community based outpatient treatment programs~     for alcohol use disorders will wear SCRAMx for a 12-week period. They will be randomized to~     standard care or standard care plus CM, with reinforcement contingent upon attendance at~     treatment. The investigators will assess treatment attendance and alcohol use via SCRAMx and~     self reports. The investigators expect that patients randomized to the CM intervention will~     remain in treatment longer and show reductions in both SCRAMx assessed and self reported~     drinking days relative to those randomized to standard care.~   "
108826|NCT02143024|"~     Despite the public health importance of clinical depression, more than 50% of depressed~     adults receive inadequate or no treatment, with even higher rates of under-treatment in men~     and minorities. Family members and/or friends often assist older adults in their health care~     and may help overcome barriers to formal care, yet there is a lack of primary care-based~     interventions that mobilize family members and friends to improve depression treatment. In~     partnership with a community-based clinic, this research will address this scientific gap by~     developing and then testing the feasibility and acceptability of a family-based intervention~     that can be delivered pragmatically in a primary care setting serving large numbers of older~     minorities.~   "
108827|NCT02143011|"~     The main objectives of this study are to test the hypotheses that: 1) consumption of~     beverages sweetened with sucrose will increase risk factors for cardiovascular disease to a~     greater extent than a naturally-sweetened fruit juice such as orange juice, and 2) chronic~     psychological stress may augment the adverse metabolic effects of sugar intake. The study~     intervention consists of 2-week's consumption of 25% of energy as sugar provided either as a~     sucrose-sweetened beverage or naturally-sweetened orange juice.~   "
108880|NCT02142296|"~     Primary Objectives:~      To assess the efficacy of intravitreal administered Eylea in preventing visual loss in~     subjects with a retinal pigment epithelial detachment (PED) subtype of neovascular~     age-related macular degeneration (AMD) measured by mean change in BCVA at Month 12 compared~     to Baseline.~      Secondary Objectives:~        1. To assess the safety and tolerability of repeated intravitreal administration of Eylea~          in subjects with the PED subtype of neovascular AMD for a period of 1 year~        2. To assess the effect of repeated intravitreal administration of Eylea on Central~          Subfield Thickness (CSFT), Central Subfield Volume (CSFV), and PED height and volume.~        3. To assess the effect of repeated intravitreal administration of Eylea on vision related~          quality of life in subjects with PED study type of neovascular AMD assessed using the~          NEI/VFQ-25 questionnaire~   "
108828|NCT02142998|"~     Obesity has become a significant health problem in Canada. It is known to be a risk factor~     for many diseases, including Gastro-Esophageal Reflux Disease (GERD). When medical efforts to~     lose weight fail, patients often consider bariatric surgical procedures as the next step. The~     two most common bariatric procedures performed are Roux-en-Y Gastric Bypass (LRYGB) and~     Laparoscopic Sleeve Gastrectomy (LSG). The gold standard for diagnosing GERD is Esophageal pH~     monitoring, as it is the most objective method to document the reflux, assess the severity~     and monitor the response to treatment of the disease. In the last few years LSG has gained in~     popularity due to its simplicity and short operative time. Currently the comparison between~     bariatric surgery and GERD symptoms is very one sided. There are significant numbers of~     studies with conclusive results that state that LRYGB has a positive effect on GERD symptoms,~     however there is little evidence that states the same about LSG. This means that the~     relationship between LSG and GERD is inconclusive. An objective evaluation of GERD using 24~     hour pH monitoring and validated CRFs at different follow up time points will contribute~     greatly to our understanding of what this relationship might be.~   "
108829|NCT02142985|"~     Vascular filling is the main treatment of hypovolemia. Hypovolemia diagnosis can be difficult~     in some situations and need to be confirmed with other investigations such as semi invasive~     cardiac output measurement based on the Flo-Trac receptor and the Vigileo monitor.~      Venous oxymetry based on the ScvO2 values represent a valuable way to predict responsivness~     to fluid filling maneuver in patients with hemodynamic instability.~   "
108830|NCT02142972|"~     The aims of this study are to investigate whether pelvic pain and low back pain disability~     are associated with postpartum depression and to compare the prevalence between women without~     Low back pain and disability and women with Low Back Pain (LBP) and disability every~     trimester, and correlate postpartum Depression and some clinical and biopsychosocial~     variables: subgroups of LBP, disability, pain intensity, pain widespread and nationality, in~     a cohort of Spanish women at 2 months postpartum.~   "
108831|NCT02142959|"~     Radiation dermatitis is experienced by almost all patients (up to 95%) receiving radiation~     therapy for cancer. Radiation dermatitis can be a serious condition because, in addition to~     its direct physical complications and the resulting impact on overall quality of life, it can~     also be a dose-limiting toxicity requiring changes to the prescribed course of radiation~     therapy. The most common strategy employed in an attempt to prevent or minimize radiation~     dermatitis involves moisturization of the irradiated area, use of a mild soap to keep the~     area clean, and minimizing exposure to potential mechanical irritants, such as scratching and~     rough clothing. However, this strategy has been shown to lack clinically significant~     efficacy. Consequently, there is a clinical need for new treatments that are effective in~     protecting against radiotherapy-induced oxidative stress and the subsequent development of~     radiation dermatitis.~      Based on data from previous studies in animals and humans, Reata believes that omaveloxolone~     (RTA 408) Lotion may effectively prevent and mitigate radiation dermatitis in oncology~     patients undergoing radiation therapy.~      This randomized, double-blind, vehicle-controlled, parallel-group trial will study the~     efficacy, tolerability and safety of two concentrations of omaveloxolone (RTA 408) Lotion (3%~     and 0.5%) versus vehicle in patients with breast cancer for whom radiation therapy is~     recommended.~   "
108832|NCT02142946|"~     The primary objective of this project is to track changes over time in balance control~     parameters measured during stance and gait for different groups of multiple sclerosis (MS)~     patients. Our primary goal is to determine whether these changes in balance control over time~     predict transitions in MS progression to a more disease affected state, and are different~     from changes over time for patients with balance deficits due to vestibular sensory~     disorders. A part of this goal is also to determine whether these changes in balance control~     are correlated with changes in patients' self-reported deficits and are similar to those~     changes in balance control of patients with peripheral vestibular loss. The secondary~     objective is to determine for multiple sclerosis (MS) patients the relationship of their~     balance parameters to different gait speeds, in order to advise them on, and promote via~     feedback, safe walking speeds. Fulfilling the first of our objectives would lead to better~     tracking of MS disease changes over time, earlier quantification of onset of symptoms~     suggesting a worsening of disease status, and, we assume, greater patient satisfaction~     knowing that quantification of symptoms fits subjective feelings of balance deficits during~     stance and gait. Achieving the second objective would lead to improved balance during gait.~     We aim to carry out these objectives using equipment (SwayStar) which we have proven is~     sensitive to MS induced balance deficits {2}, but costs far less to operate and maintain than~     previously used quantification tools. We aim to investigate the balance deficits during gait~     in different MS patient groups using a multimodal approach with a SwayStar system (analysis~     of balance during stance and gait in terms of trunk-pelvis movements near the centre of mass)~     and patient questionnaires.~   "
108833|NCT02142933|"~     1. At the University Hospital Basel, Switzerland, a simplified screening for group B~          streptococci (GBS) of vagina and perineum has been performed since several years.~          Reliable detection of GBS is critical to prevent GBS transmission during delivery with~          antimicrobial prophylaxis. Transmission of GBS to the neonate may otherwise lead to~          severe infection and complications in the neonate. Centers for Disease Control and~          Prevention (CDC) and other international organizations recommend a vaginal and~          additional rectal swab.We therefore aim to test this simplified screening against the~          international gold standard.~        2. Antibiotic resistant bacteria may reside in the genital tract of an expected mother and~          may be transmitted to the new-born during delivery. In case of infection of the pregnant~          woman or the neonate, application of standard antimicrobial treatment will~          insufficiently cover these extended spectrum beta-lactamase (ESBL) producing bacteria.~          Therefore, colonization with ESBL in pregnancy needs to be known to potentially deliver~          adequate antimicrobial treatment.~   "
108834|NCT02142920|"~     The purpose of the study is to characterize how PF-05212384 is metabolized in the body~     following a single intravenous dose of radioactively labeled drug ([14C]-PF-05212384).~   "
108881|NCT02142283|"~     The purpose of the study is to evaluate the hypothesis that Trevo thrombectomy plus medical~     management leads to superior clinical outcomes at 90 days as compared to medical management~     alone in appropriately selected subjects experiencing an acute ischemic stroke when treatment~     is initiated within 6-24 hours after last seen well.~   "
108835|NCT02142907|"~     In a general radiation oncology practice, breast cancer typically comprises approximately 25%~     of the total patient caseload.1 Surgery is the primary modality of treatment. Radical~     mastectomy remained the mainstay of surgical therapy into the 1970s. Breast-conserving~     surgery followed by radiation therapy to the intact breast is an established standard of care~     for the majority of women with early stage invasive breast cancer. Recommended techniques for~     breast-conservation treatment are local excision of the primary tumor, preferably with clear~     margins, axillary lymph node dissection, and breast irradiation (45 to 50 Gy), usually with a~     boost (10 to 20 Gy, depending on tumor size and status of the surgical margins).~      The aim of this study is to compare the two boost regimen 10Gy/5#/1 week with 16Gy/8#/1.5~     weeks in post lumpectomy patients of early stage breast cancer, following whole breast~     irradiation (WBI).~      The study will include 50 patients, (25 in each arm) of early stage post lumpectomy breast~     cancer patients. Each patient will be treated by WBI followed by tumor bed boost with either~     electron beam therapy or 3D CRT. The primary end point of the study will be assessment of~     acute and late radiation toxicities, cosmetic score analysis and local control between two~     schedules. Secondary end points will be recurrence-free survival.~   "
108836|NCT02142894|"~     To compare the results of the investigational test to the currently approved QuantiFERON-TB~     Gold In-Tube test.~   "
108837|NCT02142881|"~     To date, most observational and all intervention studies have defined hypertension on the~     basis of clinic blood pressure (BP). Measurement of BP outside the clinic with home or~     ambulatory BP provides a better estimate of the risk of cardiovascular disease and all-cause~     mortality. Using clinic and ambulatory BPs, patients can be categorized as normotensive~     (normal clinic and ambulatory BPs), white-coat hypertension (elevated clinic BP with normal~     ambulatory BP), masked hypertension (normal clinic BP with elevated ambulatory BP), and~     sustained hypertension (elevated clinic and ambulatory BP). Approximately one third of~     patients with chronic kidney disease (CKD) with normal clinic BP have elevated ambulatory BP~     (masked hypertension). We demonstrated that, among participants from the Chronic Renal~     Insufficiency Cohort (CRIC) study, low estimated glomerular filtration rate (eGFR) and~     elevated proteinuria are associated with increased odds of masked hypertension. Additionally,~     participants with masked hypertension had increased risk for target organ damage as assessed~     by left ventricular mass and pulse wave velocity. These results in participants with CKD are~     consistent with prior studies in patients with normal renal function that demonstrated a~     two-fold increased risk for cardiovascular events in patients with masked hypertension~     compared to patients with normal clinic and ambulatory BP. Despite this elevated risk for~     adverse outcomes, patients with masked hypertension have been excluded from hypertension~     trials because of their normal clinic BP. Therefore, it is unknown whether the reduction in~     target organ damage and adverse cardiovascular outcomes associated with treatment of~     hypertension extends to patients with masked hypertension. To address this important gap in~     knowledge, we are planning a randomized, controlled trial to evaluate whether~     antihypertensive treatment can modify BP patterns in patients with masked hypertension, that~     is, convert them to controlled clinic and ambulatory BP. We will also evaluate the effect~     antihypertensive treatment on target organ damage in patients with masked hypertension. The~     current study is a pilot randomized controlled trial to evaluate the feasibility of the~     planned trial and the effect of antihypertensive therapy on clinic and ambulatory BP,~     proteinuria, and target organ damage in patients with masked hypertension.~   "
108838|NCT02142868|"~     To provide access to palbociclib to post-menopausal women with HR-positive, HER2-negative~     advanced breast cancer who are deemed appropriate for letrozole therapy (Canada: first-line~     patients only).~   "
108839|NCT02142855|"~     The first goal of this study is the follow young and older people over a period of 8 weeks to~     define the processes responsible for loss of muscle length and width in age-related muscle~     wasting (sarcopenia) and allow us to look at age-related differences in tendon. Secondly, we~     will assess two different exercise interventions for reversing human sarcopenia; one which~     involves shortening of the muscle and the other which involves lengthening, whilst also~     studying why these exercises work the way they do. This project will have significant~     implications for our understanding of the control of skeletal muscle and tendon size in~     humans, particularly in relation to sarcopenia and the surrounding health issues.~   "
108840|NCT02142842|"~     Adipose stem cells and platelet rich plasma can regenerate the injured cartilage.~   "
108841|NCT02142829|"~     This study was conducted to compare the effectiveness of two local pain control methods in~     bariatric patients by assessing the amount of postoperative pain and amount of postoperative~     pain medications needed. This information was used to determine which local anesthetic~     provided the best pain control.~   "
108842|NCT02142816|"~     Targeting the amount of fluid given to measurements of the patients own fluid status during~     major abdominal surgery has been linked with improved speed of recovery of gut function and~     reduced length of hospital stay, mortality and complications.~      Pleth variability index (PVI) offers a noninvasive, risk and pain free alternative to more~     invasive forms of monitoring to direct how much fluid to give.~      The study aims primarily to measure and compare how much fluid is given when guided by PVI~     compared to the established technique; oesophageal doppler during major abdominal surgery.~      The study will compare 40 patients undergoing major elective abdominal surgery. Patients will~     receive intraoperative fluid guided by either oesophageal doppler or PVI. Secondarily, the~     study will examine biochemical markers, length of hospital stay and how frequently~     complications occur~   "
108843|NCT02142803|"~     This phase I trial studies the side effects and best dose of raptor/rictor-mammalian target~     of rapamycin (mTOR) (TORC1/2) inhibitor MLN0128 when given in combination with bevacizumab in~     treating patients with glioblastoma, a type of brain tumor, or a solid tumor that has spread~     and not responded to standard treatment. TORC1/2 inhibitor MLN0128 may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies,~     such as bevacizumab, may interfere with the ability of tumor cells to grow and spread.~     Bevacizumab may also stop the progression of tumors by blocking the growth of new blood~     vessels necessary for tumor growth.~   "
108844|NCT02142790|"~     This is a open-label study in patients with metastatic breast cancer to evaluate the~     antitumor activity and safety of weekly dose-dense paclitaxel liposome injection compared to~     3-weekly regimen.~   "
108845|NCT02142777|"~     The purpose of this study is to determine if S-equol could benefit persons with Alzheimer's~     Disease (AD).~   "
108846|NCT02142764|"~     Most experts in the field consider Multiple Sclerosis as the main auto immune disease of the~     central nervous system. In spite of many works, the data in the literature concerning the~     antigens targeted by the CD8+ T-Cell response are still contradictory and insufficient.~   "
108904|NCT02141971|"~     Non-randomized natural history study involving 12 subjects with Down Syndrome, who are aged~     30-60 years old. This study will observe 3 different groups: four non-demented subjects~     between ages 30-40 years old, four non-demented subjects between ages 40-50 years old, and~     four demented subjects 50-60 years old.~      Currently available longitudinal data in DS suggest a high rate of transition to dementia~     from the late 40s through the early 50s of these individuals. This, together with the~     universal presence of plaques in DS by their mid 40s makes this age range ideal for studying~     the development of AD.~   "
108847|NCT02142751|"~     Enterobacterieaceae (and specially Escherichia coli) showing resistance due to~     multidrug-resistant Escherichia coli, plasmid mediated AmpC or quinolone resistance caused by~     chromosomal mechanisms have spread worldwide during the last decades. This is important~     because many of these isolates are also resistant to other first-line agents such as~     fluoroquinolones or aminoglycosides, leaving few available options for therapy, and this~     condition is associated with increased morbidity- mortality and length of hospital stay.~     While carbapenems are considered the drugs of choice for multidrug-resistant Escherichia coli~     and AmpC producers, recent data suggests that certain alternatives may be suitable for some~     types of infections.~      At the present time, finding therapeutic alternatives to carbapenems and cephalosporins for~     the treatment of invasive infections due to multidrug-resistant Escherichia coli is critical.~     Fosfomycin was discovered more than 40 years ago but was not investigated according to~     present standards, and thus is not used in clinical practice except in desperate situations.~     It is one of the so-considered neglected antibiotics with high potential interest for the~     future.~      With the aim of demonstrate the clinical non-inferiority of intravenous fosfomycin compared~     to meropenem or ceftriaxone in the treatment of bacteraemic urinary tract infections caused~     by multidrug-resistant Escherichia coli . The investigators propose a real practise~     randomised, controlled, multicentre phase III clinical trial to compare the clinical and~     microbiological efficacy and safety of intravenous fosfomycin (4 grammes every 6 hours) with~     meropenem (1 gramme every 8 hours) or ceftriaxone (1 gramme every 24 hours) as targeted~     therapy of the previously specified infection; change to oral therapy according to predefined~     options is allowed in both arms after 5 days. Follow-up for the study is planned up to 60~     days.~   "
108848|NCT02142738|"~     This is a study to assess the efficacy and safety of pembrolizumab (MK-3475/SCH 900475)~     compared to standard of care (SOC) platinum-based chemotherapies in the treatment of~     participants with previously untreated stage IV, programmed cell death ligand 1 (PD-L1)~     strong expressing Non-Small Cell Lung Cancer (NSCLC). The primary hypothesis of this study is~     that participants with PD-L1 strong NSCLC will have a longer Progression Free Survival (PFS),~     as assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) when~     treated with pembrolizumab than when treated with SOC platinum-based chemotherapies.~      With Amendment 09 (20 December 2017), once participants have achieved the study objective or~     the study has ended, participants will be discontinued from this study and enrolled in an~     extension study to continue protocol-defined assessments and treatment.~   "
108849|NCT02142725|"~     The purpose of this study is to compare two different dosing regimens of phosphatidylcholine~     versus placebo for the induction of remission in ulcerative colitis patients non-responsive~     to standard mesalamine treatment.~   "
108850|NCT02142712|"~     Stroke is the 4th leading cause of death in United States with an estimated 1 death every 4~     minutes. On average, someone suffers from stroke in United States every 40th second. Stroke~     recurs in 1 out of 4 stroke patients. About 87% of the strokes are as a result of ischemic~     insult. The total economic burden from stroke accounts to 38.6 billion dollars per year.~     Stroke is also one of the leading causes of long term disability. Current stroke therapies~     concentrate mainly on acute revascularization, sub-acute rehabilitation and secondary~     prevention.~      Neuroprotection is not the mainstay of treatment modality as there are no effective regimen~     which has satisfied stroke clinicians and researchers. Many neuroprotection agents have shown~     excellent pre-clinical results but have failed in clinical translation. Thus we need to find~     new treatments in order to decrease the mortality and morbidity caused by stroke.~      The investigators hypothesize that adopting a narrower therapeutic window, with treatment~     initiation in the first six hours, may demonstrate a positive or significant short and long~     term neuroprotective effect from NMDA/Glutaminergic or histaminergic antagonism when compared~     with standard of care.~   "
108851|NCT02142699|"~     A recent analysis of over 4500 cardiac surgical patients at the Royal Infirmary of Edinburgh~     has confirmed that acute kidney injury (AKI) is not only a relatively common post-operative~     complication but is associated with prolonged hospital stay, and increased risk of death.~     There is currently no specific therapy available except supportive care.~      In laboratory studies, heme arginate (HA), a drug licensed for human use, has been shown to~     upregulate the anti-inflammatory enzyme hemeoxygenase-1 (HO-1) and protect aged mice from~     acute kidney injury.~      This study will bring this research into the human arena. It will aim to evaluate the minimum~     effective dose of HA and verify its safety in this specific group of patients. This will be~     the next step in investigating if HA could be a potential protective treatment for reducing~     AKI in patients about to have cardiac surgery.~      Patients who are due to have cardiac surgery and are aged 60 or above will be approached for~     inclusion in the study. If agreeable, they will be randomly assigned to receive either HA at~     a dose of 1mg/kg or 3mg/kg. There will be 10 patients in each group.~      Blood tests will be taken just before the study drug is given, at 6 hours, 24 hours and 7~     days post dose. These samples will be used to examine the effect of HA on HO-1 at different~     doses, and will verify drug safety. Any adverse effects of the drug will be evaluated,~     although HA has an excellent safety profile when used as it is currently licensed for acute~     porphyria. Urine samples will also be collected to assess inflammation and quantify urinary~     biomarkers of AKI. This will set the scene for a randomised clinical trial of HA in cardiac~     surgical patients at high risk of AKI.~   "
108852|NCT02142686|"~     The aim of this study is to compare different filling pressures~   "
108853|NCT02142673|"~     The study aims to compare different filling pressures in operative outpatient hysteroscopy.~     Women will be divided into 3 groups. The hysteroscope will be introduced in the uterine~     cavity. Saline will be used as the distension medium and the pressure will be 80mm Hg in~     group1, 60mm Hg in group 2 and 40mmHg in group 3.~   "
108854|NCT02142660|"~     The application of SprayShield during a laparoscopic band removal (first surgical step) will~     be evaluated to see if the postoperative adhesions between the stomach, the left liver and~     the diaphragm are not severe, facilitating the surgical surgical step of a gastric bypass or~     a sleeve gastrectomy.~   "
108855|NCT02142647|"~     Current research shows that dairy protein accelerates infant weight gain, which is a risk~     factor for later on obesity and metabolic syndrome. However, dietary protein from other~     sources haven't been studied yet. This longitudinal study will compare two complementary~     feeding regimens with dietary protein mainly from 1) meat; 2) dairy on infant growth, body~     composition and gut microbiome from 5 to 12 months of age in formula fed infants. Healthy~     infants at approximately 5 months of age will be randomized to either a meat protein, or a~     dairy protein group with complementary protein mainly from meat or dairy. Infants will~     consume one of these diets for 7 months (6-12 months of age) and infant growth, body~     composition, growth biomarkers and gut microbiome will be measured to compare between groups~     and over time.~   "
108856|NCT02142634|"~     The purpose of this study is to demonstrate the efficacy of budesonide for the treatment of~     active incomplete microscopic colitis.~   "
108857|NCT02142621|"~     Bronchopulmonary dysplasia (BPD) is the most common complication of extreme preterm birth. It~     impacts 10,000-15,000 infants in the US annually, including approximately 50% of infants with~     birth weight < 1000g. BPD is associated with multiple long-term adverse outcomes including~     chronic cardiopulmonary and neurodevelopmental impairments. Infants with severe BPD, defined~     as a need for ≥ 30% inspired oxygen and/or mechanical respiratory support at 36 weeks~     postmenstrual age (PMA), suffer the greatest burden of these chronic sequelae. Recurrent~     episodes of hypoxemia and prolonged exposure to supplemental oxygen are linked to the~     development of these impairments. Gastroesophageal reflux (GER) contributes to these~     mechanisms by exacerbating pulmonary inflammation and inducing bronchospasm. Unfortunately,~     clinically available methods to diagnose GER in infants are unreliable. Moreover, acid~     suppressive agents are both ineffective and carry high risk of serious life-threatening~     morbidity. Simple transpyloric feeding has promise, but has not been evaluated in BPD.~      This study will pilot N-of-1 trials to assess whether transpyloric feeds reduce airway~     complications of GER and and whether this methodology can aid in identifying individual~     infants with severe BPD who are likely to benefit from prolonged use of transpyloric feeds.~      Aim 1. To determine for each enrolled infant with severe BPD whether transpyloric compared to~     gastric feeds reduce the number of daily intermittent hypoxemic events (primary outcome) and~     improve a validated BPD severity score (secondary outcome).~      The investigators hypothesize that 80% percent of enrolled infants will have significantly~     fewer daily intermittent hypoxemic events with transpyloric compared to gastric feeds and~     will have this feeding method formally recommended.~      Aim 2. To pool results from multiple N-of-1 trials to determine whether transpyloric compared~     to gastric feeds reduce airway complications of GER in infants with severe BPD.~      The investigators hypothesize that transpyloric compared to gastric feeds will be associated~     overall with a 15% reduction in number of daily intermittent hypoxemic events.~   "
108858|NCT02142608|"~     Pilot study to evaluate the sensitivity and specificity of BR55 targeting for prostate cancer~     nodules with Gleason score greater than or equal to 7.~   "
108859|NCT02142595|"~     The investigators designed a study to determine whether dexmedetomidine versus midazolam~     combined with spinal anesthesia would provide same postoperative sleep quality in patients~     undergoing transurethral prostatic resection.~   "
108860|NCT02142582|"~     Compliance is the biggest challenge in patients with Short Bowel Syndrome (SBS) on Home~     Parenteral Nutrition. These patients need to hydrate themselves to meet the excess fluid loss~     due to their anatomy. Oral Rehydration Solution (ORS) is prescribed to all these patients.~     The investigators believe that taste of the standard ORS is the biggest reason why these~     patients are not complaint. The new ORS in the market has been prepared with this in mind.~     The investigators want to study if this new ORS will improve the compliance in this patient~     cohort.~   "
108861|NCT02142569|"~     The purpose of this study is to determine the effects of a palm-oil derived tocotrienol (TRF)~     supplement or Chinese red yeast rice (CRYR) individually and in combination on blood~     cholesterol, and particularly LDL cholesterol, in individuals who have either elevated or~     normal cholesterol levels. Tocotrienols are members of the vitamin E family, and are found in~     barley, oats, rye, coconut oil and rice bran oil, but the richest source of tocotrienols is~     palm oil. Certain of these tocotrienols have been shown to be effective in lowering LDL (or~     'bad') cholesterol, with no adverse effects on the HDL (or 'good') cholesterol.~   "
108862|NCT02142556|"~     Purpose To evaluate the efficacy and safety of once-daily quetiapine extended release (XR) in~     patients with schizophrenia switched from other antipsychotics which were suboptimal due to~     insufficient efficacy or insufficient tolerability.~      Methods:~      This was a 12-week, open-label study conducted in the Chinese population in Taiwan.~     Quetiapine XR was administrated at 300 mg on day 1, 600 mg on day 2 and up to 800 mg after~     day 2. From day 8 until the end of the study, the dose of quetiapine XR was adjusted within~     400-800 mg per day, depending on the clinical response and tolerability of the patients.~   "
108863|NCT02142543|"~     This is a prospective, randomized, blinded, placebo-controlled, crossover clinical trial to~     evaluate the efficacy of 2-DeNT oral topical powder in the treatment of recurrent aphthous~     stomatitis (RAS). To be included in the study, subjects must have had minor RAS ulcers of~     less than 48 hours duration. It was randomly determined which powder was used first; all~     subjects used both the 2-DeNT powder and the placebo powder. Subjects applied the powder~     twice daily and maintained a daily log recording the size of the ulcer, its erythema score,~     and their level of pain. The subjects continued applying the 2-DeNT powder until the ulcer~     was resolved.~   "
108864|NCT02142530|"~     This research study is evaluating a drug called carfilzomib used in combination with another~     drug called belinostat with participants who have relapsed or refractory non-Hodgkin lymphoma~     (NHL).~   "
108865|NCT02142517|"~     Postoperative pancreatic fistula (POPF) remains a challenge even at specialized centers, and~     also affect significantly the surgical outcomes . The incidence of POPF after~     pancreaticoduodenectomy among different studies, ranging from 5 to 30%.Morbidity and~     mortality after pancreaticoduodenectomy are usually related to surgical management of the~     pancreatic stump. The safe pancreatic reconstruction after pancreaticoduodenectomy continues~     to be a challenge at high volume centers. The variety of reconstruction is a reflection of~     the lack of ideal one.Duct to mucosa and invagination are two classic PJ techniques. Many~     studies compared both techniques, but their surgical outcomes still unclear.The aim of the~     study was to assess the effectiveness and surgical outcomes of both techniques of PJ after~     pancreaticoduodenectomy.~   "
108866|NCT02142504|"~     The purpose of this study is to evaluate the safety of the norovirus bivalent virus-like~     particle (VLP) vaccine for further development by assessing the rates of serious adverse~     events (SAEs), unsolicited adverse events (AEs), solicited local and solicited systemic AEs,~     Adverse Events of Special Interest (AESIs) and AEs leading to participant's withdrawal from~     the trial.~   "
108867|NCT02142491|"~     The objective of this study is to verify the clinical tolerance to the vaccine Flumist~     (intranasal live attenuated influenza vaccine) in a population of egg allergic children. More~     specifically, the investigators want to estimate the risk of severe allergic reaction arising~     within 24 hours following the vaccination of egg allergic with Flumist.~   "
108900|NCT02142036|"~     The metastatic lesions may be very different from the primary tumor because of intrinsic~     tumor heterogenity, clonal selection through metastatic process and following previous~     cytotoxic treatments. Metastatic tumor harboring actionable targets or signaling pathways may~     respond to inhibitory agents directed against specific aberrations irrespective of tumor~     origin. In the MetAction study, patients will receive therapy based on molecular aberrations~     in the metastatic lesions, actionable target identification (ATI), rather than on~     histological tumor type.~      The ATI rate in an unselected metastatic patient population is uncertain, and response rates~     associated with ATI based targeted therapy have hardly been reported. In this perspective,~     The MetAction study is essentially a feasibility study aiming to tailor metastatic cancer~     therapy based on genomic profiles.~   "
108868|NCT02142478|"~     Physical activity (PA) benefits both physical and psychological health, yet the majority of~     UK adults are physically inactive. Exercise for Health (EFH) is a General Practitioner (GP)~     exercise referral scheme run in Liverpool for people who are inactive with a medical~     condition. Patients are referred by their GP practice, where they receive 12 weeks of~     subsidised exercise classes at their local leisure or community centre.~      In 2012, one of the thirteen EFH centres (Centre A) introduced some changes to try and~     improve EFH at their centre. These changes included:~        -  a pre-scheme meeting with a health trainer, to help the patient decide if EFH is for~          them.~        -  exclusive classes (gym or activities) available daily for EFH participants (compared to~          gym only classes two or three times a week in other centres).~      This non-randomised study will compare the effectiveness of the adapted EFH (Centre A) with~     standard EFH delivery (Centre B). All participants referred to centre A (n=100 approx) or~     centre B (n=100 approx) during the study period will be invited to take part. Changes in~     self-reported PA, PA self-efficacy and psychological wellbeing will be measured at the end of~     EFH (12 weeks) and at 12-month follow-up. A subsample of participants (n=15 from each centre)~     will take part in qualitative interviews to explore the factors that contribute to~     effectiveness.~      A secondary aim is to explore psychological factors contributing to any differences between~     the two centres. Self-determination theory suggests that where participants feel they are~     offered choice, feel they are competent at exercise, and feel connected to people they~     exercise with, they will be more intrinsically motivated and more likely to continue~     exercising. Therefore it is hypothesised that participants attending the adapted EFH will be~     more motivated and more likely to continue exercising.~   "
108869|NCT02142452|"~     The investigators will test the efficacy of a tailored behavioral lifestyle modification~     program to support cardiovascular health in postpartum women with excessive gestational~     weight gain. This program will include a mobile health texting component postpartum to~     support changes in nutrition and physical activity. The investigators will randomize women~     into either the control arm (usual care) or the intervention (usual care + mobile health~     program postpartum). The women will be recruited during their 3rd trimester once they have~     been identified as gaining too much weight according to the 2009 IOM guidelines during~     pregnancy.~   "
108870|NCT02142439|"~     Strength training has been found effective for enhancement of bone health, muscle strength~     and body composition among premenopausal women from the general population, however it is~     unclear to what extend strength training might improve these parameters among women with~     eating disorders. The aim of this study is therefore to examine acute and long-term effects~     of strength training among persons with eating disorders. The study is a randomized,~     controlled, single-blinded trial with three intervention groups and one control group. The~     three intervention groups will perform different volumes of strength training. The~     intervention period is 16 weeks with three sessions per week. At pretest, posttest, and 6~     months, 12 months and 24 months follow-up, the following variables will be measured: bone~     health, muscle strength, power, body composition hormone levels, physical activity level and~     compulsivity, body awareness, quality of life, and eating disorders psychopathology.~     Qualitative in-depth interviews will be carried out to explore the participants' experiences~     with strength training. The study is carried out in Norway, and is performed in collaboration~     with Telemark University College, University of Agder, Norwegian school of sport sciences and~     Modum Bad psychiatric center. The results from the study might implicate on strength training~     as part of treatment for eating disorders.~   "
108871|NCT02142426|"~     The purpose of this study was to pursue statistical analysis on a series of molecular~     laboratory results obtained from chronic wounds. It elucidated diversity, quantification, and~     other aspects of microbial diversity in chronic wounds.~   "
108872|NCT02142413|"~     The primary aim of this prospective observational study is to investigate whether an enhanced~     diagnostic MRI work-up (including cardiac MRI, angiography of the aortic arch and the~     brain-supplying arteries) combined with an in-hospital Holter-ECG of up to 5 days duration~     leads to a significant increase in relevant pathologic findings with respect to stroke~     aetiology as compared to the findings obtained by a routine diagnostic work-up (including~     stroke unit monitoring, 24h-Holter-ECG, echocardiography, Doppler-ultrasound of the~     brain-supplying arteries) in patients with acute ischemic stroke and no atrial fibrillation~     according to past medical history or baseline ECG. A better understanding of the stroke~     aetiology may improve secondary stroke prevention and long term outcome.~   "
108873|NCT02142400|"~     This is a randomised, double-blind, placebo-controlled multiple ascending single study. It is~     hypothesised that at least dose of DS-1093a will be safe and tolerable over a 2-week~     treatment period and will result in increases in reticulocyte count and haemoglobin~     concentrations in healthy male volunteers~   "
108874|NCT02142387|"~     Despite aggressive CPR training, the outcome of cardiac arrest is not good. The problem is~     method of education. So, the investigators want to add the dispatcher-assisted CPR simulation~     into conventional CPR training. In this study, the investigators aim is to investigate the~     effect of newer CPR training program.~   "
108875|NCT02142361|"~     Evaluate the clinical performance of existing wearers of hydrogel toric lenses when refitted~     with Avaira toric silicone hydrogel contact lenses over 1 week of wear.~   "
108876|NCT02142348|"~     To popularize knowledge of prevention and health care of osteoporosis.To investigate the~     prevalence of primary osteoporosis in community residents.~   "
108877|NCT02142335|"~     The purpose of this research study is to test an experimental combination of drugs to~     determine if they can cause shrinkage or even complete disappearance of your melanoma. The~     two drugs being tested in combination are Rituxan and Abraxane~   "
108878|NCT02142322|"~     This is a Phase II Trial of Perioperative Chemotherapy with Oxaliplatin, 5-Fluorouracil,~     Leucovorin(MODIFIED FOLFOX6)in Patients with Locally Advanced Operable Gastric Cancer.~   "
108879|NCT02142309|"~     Type 2 diabetes is epidemic and its treatment has become more and more difficult. Consensus~     algorithms have been developed to help clinicians to select among the numerous medications~     and their combinations for achieving and maintaining a target glycated hemoglobin A1c (HbA1c)~     of <7%.~      AMAZING, a pragmatic clinical trial, aims to compare commonly used oral diabetes medications,~     when combined with metformin, on glycemia-lowering effectiveness.~   "
108901|NCT02142010|"~     The purpose of this study is to evaluate the pathological complete response (pCR) rate in~     breast cancer patients treated with weekly paclitaxel liposome injection plus cisplatin~     preoperative regimen.~   "
108902|NCT02141997|"~     This study is a Phase 2 randomized, double-blind, double-dummy, parallel-group study designed~     to assess the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of multiple~     doses of ABT 122 in subjects with active rheumatoid arthritis (RA) who are inadequately~     responding to methotrexate (MTX) treatment.~   "
108927|NCT02141672|"~     To assess the efficacy of 2 doses of voclosporin compared to placebo in achieving complete~     remission after 24 weeks of therapy in subjects with active lupus nephritis.~   "
108882|NCT02142270|"~     Background The burden of sudden cardiac death (SCD) in Africa is unknown. Our aim is to~     assess the epidemiology of SCD in Africa. Methods The sub-Saharan Africa SCD study is a~     prospective, multicenter, community-based registry monitoring all cases of cardiac arrest~     occurring in victims > 15 years old. Investigators will use the definition of established SCD~     if an unexpected death without obvious extracardiac cause, occurred with a rapid witnessed~     collapse, or if unwitnessed, occurred within 1 hour after the onset of symptoms; probable SCD~     if an unexpected death without obvious extracardiac cause occurred within the previous 24~     hours. After approval from institutional boards, Investigators will record demographic,~     clinical, electrocardiographic and biological variables of SCD victims (including survivors~     of cardiac arrest) in several sub-Saharan African cities. All deaths occurring in residents~     of districts of interest will be checked for past medical history, circumstances of death,~     and autopsy report (if possible). Investigators will also analyze the employment of~     resuscitation attempts during the timeframe of sudden cardiac arrest (SCA) in various patient~     populations throughout countries. Conclusion This study will provide comprehensive,~     contemporary data on the epidemiology of SCD in sub-Saharan Africa and will help in the~     development of strategies to prevent and manage cardiac arrest in this region of the world.~   "
108883|NCT02142257|"~     The purpose of this study is to compare Gastric Bypass and AspireAssist Aspiration Therapy~     over 5 years of treatment with regards to weight loss, quality of life, complications,~     adverse events, and health economics.~   "
108884|NCT02142244|"~     Sentinel node biopsy is a surgical procedure used to find melanoma lymph node metastasis~     (i.e. groin/axilla) in very early stages. This study aims to add a new technology over the~     standard procedure - a fluorescent contrast (indocyanine green) using special light (near~     infra-red) - looking for more precise diagnosis of the presence of the lymph node metastasis.~   "
108885|NCT02142231|"~     Test anxiety is a well-known phenomenon in general population, but only few scientific~     advances have been made in order to fully understand and prevent this circumstance.~      The number of students which use neuro enhancement to improve their performance and to~     prevent test anxiety, is increasing. A US-survey estimated that almost 7% of students in US~     universities have used prescription stimulants against anxiety, and that on some campuses, up~     to 25% of students had used them in the past year.~      Acupuncture might act as an alternate. Several trials could demonstrate, that different forms~     of acupuncture could relieve symptoms of pre-exam anxiety syndrome significantly and that~     this therapy was highly safe. In special, the investigation of single point effects in test~     anxiety could be of general interest. The acupuncture point with the most convincing evidence~     up to date is Heart 7. Yet, its effectiveness has mainly been chosen in combination with~     other acupuncture points and not as single remedy in test anxiety. Therefore we establish a~     trial investigating the immediate needling effects at Heart 7 on the reduction of test~     anxiety.~      Therefore qe implemented a validated stress test, the Trier Social Stress Test TSST, which is~     known to provoke serious stress responses in healthy subjects. 24 medical students with test~     anxiety in there history will be randomised to two interventional groups (verum acupuncture~     and laser acupuncture), being treated and then pass this test. Main outcome is the increase~     of cortisol in saliva, which is the standardized measure of stress response used in this~     paradigm.~   "
108886|NCT02142218|"~     The purpose of this program is to provide treatment with nivolumab to subjects with Stage III~     or Stage IV advanced melanoma.~   "
108887|NCT02142205|"~     The primary objective is to evaluate the safety and tolerability of natalizumab (BG00002,~     Tysabri®) in the study population (Russian participants with relapsing remitting multiple~     sclerosis). The secondary objectives are to look at evaluation of severity of relapse,~     hospitalization and steroid use requirement; Expanded Disability Status Scale (EDSS),~     functional tests, quality of life self-assessment questionnaires including the short form~     health survey self-assessment questionnaire (SF-36) and multiple sclerosis impact scale 29~     (MSIS-29), evidence of MRI disease activity, participants free of disease activity (clinical~     activity and/MRI activity) and anti JC Virus (JCV) antibody evaluation.~   "
108888|NCT02142192|"~     The primary objective of this study is to evaluate the immunogenicity of natalizumab~     (BG00002) 300 mg subcutaneous (SC) administered to participants with relapsing multiple~     sclerosis (RMS). The secondary objectives of the study are to evaluate the safety of~     natalizumab SC injections and to evaluate the efficacy of natalizumab SC injections on~     relapses and on new magnetic resonance imaging (MRI) lesions.~   "
108889|NCT02142179|"~     The purpose of this study is to estimate the impact of a curriculum intervention on asthma~     knowledge in adolescents of a public school in Salvador-Bahia-Brazil.~   "
108890|NCT02142166|"~     The aim of this study is to improve the usability of biomarkers for the timely prediction of~     new complications following a cerebral hemorrhage, especially in combination with invasive,~     functional and local measurements for patients with aneurysmal subarachnoid hemorrhage (SAH).~     Based on analyzed biomarker profiles the chosen therapy efforts are assessed in their~     immediate and longer-term effectiveness.~   "
108891|NCT02142153|"~     F901318 is a potent new antifungal agent for the treatment of systemic fungal infections.~     This study will test it for the first time in man with the objective of assessing its safety,~     tolerability and pharmacokinetic profile.~   "
108892|NCT02142140|"~     The purpose of the study is to examine how well two types of treatment follow up work~     compared to one another:~        1. standard community follow up~        2. medication monitoring plus tailored case management follow up.~      A child's participation will involve 3 months of treatment consisting of medication and~     psychological, behavioural, and academic interventions tailored to their individual needs.~      Following this treatment, the child will be randomly assigned to receive two years of either~     community follow up or medication monitoring plus tailored case management follow up~     delivered by the study team. During both types of follow up, at 6 month intervals, the parent~     and child will be asked to complete interviews with our study personnel and comprehensive~     assessments pertaining to ADHD symptoms and various other areas of functioning.~      Parents will also be asked to obtain information from the child's teacher regarding the~     child's functioning at 6 month intervals during the school year.~   "
108928|NCT02141659|"~     To evaluate the tolerability and safety of TAK-385 in patients with androgen deprivation~     treatment-naïve non-metastatic prostate cancer~   "
108893|NCT02142127|"~     Human mass-balance studies with radiolabelled study drug are needed to evaluate the amount of~     drug that is recovered over time via different elimination routes of the body, i.e., whole~     blood, blood cells, plasma, urine, feces, and expired air. The ideal case is to be able to~     demonstrate a (near) complete recovery (≥95 %) of the administered dose.~      A good understanding of the metabolic pathway of the study drug is equally important.~     Mass-balance data, together with metabolic profiles in excreta, are used to characterize the~     biotransformation pathways of a drug and to help evaluate its drug-drug interaction~     potential.~      To this purpose, in this study, blood, urine, and feces are collected to investigate the~     metabolic profile of GFT505, and plasma and urine are collected to investigate the~     non-radioactive pharmacokinetics of GFT505 and its principle metabolite GFT1007. Other~     metabolites will be investigated in plasma and urine according to the radioactivity results.~     Non-radioactive pharmacokinetics of GFT505 and metabolites in feces will be investigated~     according to the radioactivity results.~   "
108894|NCT02142114|"~     The purpose of this study is to determine if a smaller needle size reduces discomfort~     suffered by patients both during and following intravitreal injections. It is the~     investigators belief that using a smaller size needle will help patients to be less fearful~     of intravitreal injections and more amenable to treatment. This study will also evaluate the~     effect of needle size on post injection intraocular pressure, to see if smaller needles may~     reduce wound leak and increase the intraocular pressure following injection.~      The investigators hypothesize that subject eyes injected with the smaller size needle will~     result in greater patient comfort both during and after their injection as compared to the~     eye injected with the larger needle. The investigators objective is to reduce any discomfort~     felt by patients who receive intravitreal injections. The investigators also hypothesize that~     the smaller needle will result in higher post injection pressures, and another objective is~     to determine if this can affect patient comfort and increase the risk of glaucomatous optic~     nerve damage.~   "
108895|NCT02142101|"~     Gut microbes can influence numerous aspects of human biology. Alterations in the function and~     composition of gut microbial flora (gut microbiota ) have been linked to inflammatory bowel~     disease, chronic inflammation, dyslipidemia, diabetes mellitus, atopic disorders,~     cardiovascular disease, neoplasms, and obesity. However, little is known whether renal~     failure alters the composition of gut microbiota and whether an alteration in the gut~     microbiota of patients with renal failure impacts on the development of co-morbid conditions~     such as accelerated atherosclerosis, abnormal bone mineral metabolism, and chronic~     inflammation that are associated with renal failure. Nonetheless, several lines of evidence~     suggest that renal failure alters the chemical environment of the intestinal lumen, which~     could impose a selective pressure on the growth of certain gut microbes. The investigators~     hypothesize that the gut microbiota of patients with renal failure is different from those~     without renal failure. To test this hypothesis the investigators are conducting a~     cross-sectional study of gut microbiota in patients with different degrees of renal failure~     due to polycystic kidney disease (PKD).~   "
108896|NCT02142088|"~     It has been shown that close control of blood glucose levels in the intensive care unit~     patient has benefits for patient morbidity and mortality rates as well as an impact upon~     discharge times. GlySure has previously completed an evaluation of its intra-vascular glucose~     monitoring system in patients in a surgical ICU environment after cardiac surgery. This study~     seeks to evaluate the same equipment being used in a wider range of patients with a range of~     underlying conditions who require treatment in medical ICU's. The GlySure device consists of~     a sensor that is placed into the patient's blood through a central venous catheter. It~     measures blood glucose levels continuously which allows for more rapid control of blood~     glucose levels to be achieved as compared to existing methods where blood samples are taken~     repeatedly every 15 minutes or so.~      The study is designed to show that the sensor can be used for a protracted period of time,~     giving accurate results when compared to a reference technique using the i-STAT device. The~     investigators intend to show that the device performs safely for the required time within the~     ICU.~   "
108897|NCT02142075|"~     Treatment of infections in critically ill patients remains a significant challenge to~     intensivists world-wide with persisting high mortality and morbidity. Compelling evidence~     suggests that source control of the pathogen and appropriate antibiotic therapy remain the~     most important interventions to improve patients' outcome, the latter including the~     administration of a suitable molecule at an optimized dosage regimen.~      Daptomycin is the first representative of a new family of antibiotics, the cyclic~     lipopeptides. Its bactericidal effect against Gram-positive bacteria, including~     meticillin-resistant strains, and its low renal toxicity, make it a useful antibiotic in~     critically ill patients having infections due to resistant Gram positive strains.~      Unfortunately, no PK study has been performed in infected critically ill patients without~     renal replacement therapy. A vast array of pathophysiological changes can occur in infected~     critically ill patients, leading to changes in volume of distribution and clearance of~     antibiotics in these patients, which may affect the antibiotic concentration at the target~     site.~      It is therefore important to better characterize daptomycin PK in infected patients with~     various degrees of renal failure in order to define optimal dosing regimens.~      This project aims to identify optimal daptomycin administration schemes in critical care~     patients with various degrees of renal impairment~   "
108898|NCT02142062|"~     The purpose of this study is to demonstrate that IVUS identifies more instances of~     significant iliac and common femoral vein outflow obstruction than multiplanar venography.No~     hypothesis testing is planned.~   "
108899|NCT02142049|"~     This is a Phase 1b/2, open-label, non-randomized multicenter study to assess the safety and~     efficacy of ibrutinib and lenalidomide in combination with DA-EPOCH-R in subjects with~     relapsed/refractory Diffuse Large B-cell Lymphoma (DLBCL).~   "
108903|NCT02141984|"~     Approximately 600 pediatric patients prescribed Humira Injection in usual practice according~     to the approved Korean product label will be registered into this observational study.~     Baseline data will be obtained at enrollment including demographics, underlying diseases and~     complications especially in regard to purified protein derivative (PPD) skin test, and chest~     X-ray. At routine visits for Humira Injection administration, which will occur according to~     usual medical practice, concomitant medication information and adverse events information~     will be collected for up to 70 days after the last administration of Humira.~   "
108905|NCT02141958|"~     The purpose of this study is to assess the safety and tolerability of ascending doses of a~     novel oral formulation of Fenretinide to adult cystic fibrosis (CF) patients, once-daily for~     21 days (treatment cycle). This study will include up to three (3) dose levels with minimum 7~     day breaks in between treatment cycles. For each dose level, blood samples will be collected~     for exploratory pharmacokinetic (PK) and pharmacodynamic (PD) evaluation.~   "
108906|NCT02141945|"~     The purpose if this study is to measure the sensitivity, specificity and accuracy of the~     Metabiomics Colon Polyp and Colorectal Cancer Assay for the non-invasive detection of colon~     polyps or colorectal cancer.~   "
108907|NCT02141932|"~     Among patients admitted with cerebral ischemia (stroke and transitory ischemic attack (TIA))~     it is important to reveal the underlying cause of the disease. In special it is important to~     reveal if carotid artery stenosis is present as such a finding will directly influence on~     treatment and follow-up.~      For the diagnosis of carotid artery stenosis due to atherosclerosis ultrasound examinations~     is the cornerstone, but computer tomography and magnetic resonance imaging may be better in~     some cases. Development of high quality pocket-sized ultrasound scanners has allowed for semi~     quantitatively bed-side assessment of the carotid arteries and the heart.~      The investigators aim to study the feasibility and reliability of bed-side assessment of the~     carotid arteries and the heart by pocket-sized ultrasound scanners and the clinical influence~     of this examination when performed by experienced users.~      The investigators hypothesize that a significant proportion of this patient population can be~     clarified bed-side with no need of further imaging procedures for the assessment of the~     carotid arteries and the heart.~   "
108908|NCT02141919|"~     The goal of this phase II clinical trial is to evaluate the efficacy of the completely~     non-invasive treatment option of stereotactic radiation therapy for the treatment of biopsy~     proven and growing small renal tumors.~   "
108909|NCT02141906|"~     This is a pilot study of Onconzene Microspheres for intra-arterial delivery of doxorubicin~     for the treatement of patients with unresectable hepatocellular cancer.~   "
108910|NCT02141893|"~     The aim of this group-randomized trial was to test the effectiveness of a new comprehensive~     program, which the investigators called CALMA -plus, in increasing controller medication use~     and reducing asthma symptoms. CALMA-plus involved the CALMA home-based family intervention,~     plus educational training of physicians and nurses, as well as screening for asthma in~     clinics serving Medicaid island Puerto Rican children with asthma. Because the provider~     training was expected to have an impact on the entire clinical setting where trained~     providers work, as well as the patients using that setting, the investigators randomized~     clinic groups rather than individual patients. The investigators compared the CALMA-Plus~     intervention to a CALMA-only group, which the investigators expected to obtain the same~     benefits as the investigators have previously documented.~   "
108911|NCT02141880|"~     College drinking associated with sporting events is characterized by excess alcohol, along~     with food intake, over the duration of hours has the potential to cause a build up of fat in~     the liver. Fatty liver can increase blood glucose concentrations leading to a prediabetes~     like state.~      The present study will determine how overweight men respond to the over-consumption of~     alcohol/food to identify which characteristics might protect some men from fatty liver, while~     others might be more susceptible to this condition.~      The goal of this work is to determine the direct impact of alcohol/food intake to cause acute~     fatty liver through the stimulation of de novo lipogenesis in 20 overweight, healthy men.~     Understanding individual susceptibility to alcohol-induced fatty liver will aid in the~     development of strategies designed to help people mitigate these risks.~      Hypothesis is that 5h excess consumption of alcohol and food will increase liver~     triglycerides by 4% or more, in comparison to fasting state.~   "
108912|NCT02141867|"~     We will conduct a 7 day cohort study of consecutive patients aged 16 years and older~     undergoing inpatient noncardiac surgery. Patients will be followed up for a maximum of 30~     days. We will follow the original European Surgical Outcomes Study (EuSOS) study design.~      The primary outcome is in-hospital mortality. Secondary outcomes include length of stay and~     admission to intensive care. Centres across South Africa representing the public service will~     recruit patients. This study will run from 19 May 2014 to 26 May 2014.~   "
108913|NCT02141854|"~     The primary objective of this study was to evaluate the efficacy of fluticasone propionate~     (Fp) multidose dry powder inhaler (MDPI) and fluticasone propionate/salmeterol xinafoate (FS)~     MDPI when administered over 12 weeks in patients 12 years of age and older with persistent~     asthma.~   "
108914|NCT02141841|"~     This study was performed in 131 adult patients undergoing transurethral, urological or lower~     limb surgery under combined spinal and epidural anesthesia. Patients were stratified~     according to age: 20-30, 31-40, 41-50, 51-60, 61-70, and 71-80 years. The spinal component of~     the anesthetic was established by bolus administration of up-and-down doses of 0.75% plain~     bupivacaine, determined by Dixon's method. The degree of motor block after intrathecal~     administration of each concentration was evaluated by the modified Bromage and Hip motor~     function score. The EC50 were estimated from the up-and-down sequences using the method of~     Dixon and Massey and logistic regression. Other endpoints were included on the basis of~     sensory block level, duration of motor blockade, hypotension, and vasopressor requirements.~   "
108915|NCT02141828|"~     A subset of patients with acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL)~     harbor rearrangements of the MLL gene, which are detected either by cytogenetic or~     fluorescent in situ hybridization evaluation at the time of diagnosis. A protein called DOT1L~     plays an important role in the malignant process in these leukemias. EPZ-5676 is a molecule~     that blocks the activity of DOT1L, and is therefore being evaluated in the treatment of~     patients with MLL-rearranged leukemias.~   "
108929|NCT02141646|"~     This is a randomized controlled trial to contrast an intervention that relies on~     well-developed cognitive control systems (Motivational Interviewing; MI) to an intervention~     that relies on a more basic response to scheduled reward (Behavioral Skills Training; BST).~   "
109059|NCT02139930|"~     The main goal of this project is to compare two different approaches to reducing levels of~     nicotine in cigarettes: an immediate reduction in nicotine content in cigarettes to~     non-addictive levels or a gradual reduction in nicotine content in cigarettes to~     non-addictive levels. These two approaches will then be contrasted to a group that continues~     to smoke cigarettes with nicotine content similar to conventional cigarettes.~   "
108916|NCT02141815|"~     Chronic kidney disease is associated with the accumulation of various metabolites, i.e.,~     uremic retention solutes. Evidence is mounting that the colonic microbiota contributes~     substantially to these uremic retention solutes. Indoxyl sulfate and p-cresyl sulfate are~     among the most extensively studied gut microbial metabolites, and are associated with~     cardiovascular disease, overall mortality and chronic kidney disease progression. The most~     important regulator of colonic bacterial metabolism is nutrient availability and especially~     the ratio of available fermentable carbohydrate to nitrogen, which can be modified by intake~     of so-called prebiotics (non-digestible food ingredients). Arabinoxylan oligosaccharides~     (AXOS) are a recently developed group of prebiotics, and already demonstrated a decreasing~     effect on intestinal generation of p-cresol in healthy individuals. Whether prebiotics in~     general, and AXOS more specifically, can influence intestinal generation of microbial~     metabolites in predialysis patients has not been studied to date. An interventional study~     with AXOS will therefore be initiated to test the hypothesis that AXOS can decrease~     intestinal generation and serum concentrations of microbial metabolites in patients with CKD~     not yet on dialysis.~   "
108917|NCT02141802|"~     Children with cerebral palsy commonly use standing frames to position them to help prevent~     contracture and deformity and to help their function. There is a lack of evidence to support~     the correct dosage of standing frame use.~      The aim of this study is to pilot a randomised controlled trial of the clinical effects of~     doubling the duration of standing, using standing frames, in young children who are unable to~     walk, who have cerebral palsy or developmental delay.~      It will determine whether it is feasable to carry out a multi-centred trial.~      The study objectives will be to determine:~        1. presence of adverse events~        2. recruitment and drop out rate~        3. compliance with the intervention~        4. feasibility of the randomisation and minimisation process~        5. the proportion of the outcome measures taken~        6. effect size estimate~        7. required study costs~        8. effectiveness of blinding procedure~   "
108918|NCT02141789|"~     Research has shown that alcohol dependence often co-occurs with comorbid anxiety disorders~     and/or depression. Anxiety and depression influence the course and treatment of alcohol~     dependence and are a major risk factor for alcohol relapse within the first three months~     after detoxification. Therefore, there is need for combined treatment (integrated therapy) of~     alcohol dependence and comorbid psychiatric disorders, e.g. anxiety and/or depression. Until~     today, there are no systematic outpatient treatment offers for this special group of patients~     in Germany. In this study we want to investigate if integrated outpatient cognitive~     behavioral therapy can prevent and decrease alcohol relapse within the first three months~     after detoxification. Therefore we hypothesize that immediate start of integrated outpatient~     psychotherapy will reduce relapse variables compared to treatment as usual which is~     characterized by non-immediate start of therapy due to the required application for insurance~     coverage.~   "
108919|NCT02141776|"~     Major depressive disorder (MDD) is a significant public health problem. Existing treatment~     modalities are not always sufficient to alleviate this disorder. Treatment refractoriness is~     a common clinical problem. Transcranial direct current stimulation (t-DCS), a non-invasive~     brain stimulation technique, has been shown to be effective in alleviating depressive~     symptoms in preliminary studies. There is need to explore the role of t-DCS in~     Treatment-resistant depression (TRD). Therefore, the investigators aim to undertake this~     exploratory study.~      Aim:~      Compare the role of left prefrontal cortex anodal t-DCS daily stimulation of 4 weeks (20 week~     days) with sham stimulation in alleviating depressive symptoms in patients with TRD.~      Methodology: Patients who seek treatment in our treatment resistant depression clinic and who~     have failed to respond to treatment with two antidepressant medications will be offered to~     enroll in this study. The aim is to study 20 patients who meet the Diagnostic and Statistical~     Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for MDD between the ages of 21-65~     years. Those subjects that receive sham stimulation will be offered to have active t-DCS~     stimulation for additional 3 weeks to get any benefit that they may have otherwise missed by~     being in the sham stimulation group.~      Results and Conclusions: The investigators will compare the mean baseline and end of~     treatment Montgomery Asberg depression rating scale between the two groups. The investigators~     will compare the change in mean depression scores between the baseline and end of treatment~     in those receiving active t-DCS for a total of 7 weeks duration. This study is innovative and~     of significance in exploring the role of this novel, easy to administer, safe and cost~     effective treatment modality.~   "
108920|NCT02141763|"~     A study of UCB4940 in subjects with psoriatic arthritis to evaluate the safety and body~     distribution of UCB4940 in those patients. Neither the patient nor the doctor will know the~     treatment group.~   "
108921|NCT02141750|"~     The Registry pretends to identify stratification, diagnosis and treatment approaches in~     patients with Acute Coronary Syndrome (ACS) in community hospitals with tertiary hospitals to~     optimize resources and identify strategies to improve health care quality through the~     creation of clinical guidelines that serve for unify management and treatment methods with~     adherence to international guidelines which include suggestions for treatment and medication.~   "
108922|NCT02141737|"~     To evaluate the effect of pre-injection of lidocaine on myoclonus induced by induction with~     etomidate during general anesthesia in elderly patients~   "
108923|NCT02141724|"~     A retrospective study with the patients having a positioning consultation at hospital,~     between 2009 and 2014. In every neuromuscular disorder, the investigators describe the~     population seen in consultation, the aim of consultation, the postural problem observed in~     wheelchair, pain when sitting in wheelchair, and pressure ulcer.~   "
108924|NCT02141711|"~     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of~     TAK-438 in healthy, non-Japanese men male subjects following a randomized, double blind,~     placebo controlled, sequential panel, multiple-dose schedule.~   "
108925|NCT02141698|"~     The primary purpose of this study was to evaluate the safety, tolerability, and~     pharmacokinetics of TAK-438 following single or multiple doses of TAK-438 in healthy Western~     men, to investigate the effect of food on the pharmacokinetics of TAK-438, and to compare the~     TAK-438 pharmacokinetics of Western with Japanese men.~   "
108926|NCT02141685|"~     The purpose of this research study protocol is to collect imaging data on embryos followed to~     blastocyst stage (Day 5-6) and correlate Eeva parameters with array - Comparative Genomic~     Hybridization (aCGH) results and ongoing pregnancy rates.~   "
108930|NCT02141633|"~     The purposes of the present proposal are to 1) compare inhaled albuterol-induced changes in~     airway blood flow (Qaw), and in CO and Ppas in healthy current smokers and lifetime~     non-smokers as an index of endothelial function in the airway and pulmonary circulations, 2)~     compare the results between smokers and non-smokers, and 3) determine the effect of a 4-week~     treatment with an ICS on albuterol responsiveness of Qaw and the echocardiographic~     parameters. With this protocol the Investigators will test the hypotheses that a) there is a~     correlation between airway and pulmonary vascular endothelial function within the current~     smoker and non-smoker groups, and b) ICS treatment improves airway and pulmonary vascular~     endothelial function in the current smoker group.~   "
108931|NCT02141620|"~     This study will determine the initial efficacy, safety and tolerability of n-acetylcysteine~     as a pharmacotherapy for cocaine dependence. A rigorous, inpatient human laboratory study~     will be conducted in which the subjective, physiological and reinforcing effects of cocaine~     are evaluated during maintenance on placebo and n-acetylcysteine.~   "
108932|NCT02141607|"~     The relationship between shock, ischemia and reperfusion (I/R) injury, hemodynamic~     instability, systemic inflammatory response syndrome and multiorgan failure has been~     extensively investigated, but there is no consensus on the trigger mechanisms of tissue~     injury at the molecular level.~      Current therapies are targeted to reduce symptoms of shock and multiorgan damage but they are~     unable to act at the beginning of the cascade, because of the lack of a model explaining~     the molecular basis of shock induced tissue injury and ensuing organ damage.~      The present observational study is aimed at identifying the molecular triggers of acute heart~     failure (HF) induced by shock and to identify inflammatory mediators and markers that are~     activated in shock, with a particular emphasis on the role of uncontrolled proteolytic~     activity.~   "
108933|NCT02141594|"~     Spectrailis optical coherence tomography has come with a new posterior pole asymmetry~     analysis for glaucoma diagnosis. The aim of the investigators study was to assess its~     applicability in diagnosing early glaucoma patients.~   "
108934|NCT02141581|"~     The purpose of this study is to investigate the responses to licensed trivalent, inactivated~     influenza vaccine (TIV) delivered by different routes: intramuscular (IM) and intradermal~     (ID) and to the live, attenuated influenza vaccine (LAIV) administered intranasally -- all~     given to generally healthy male and female adult volunteers.~   "
108935|NCT02141568|"~     The purpose of this study is to check the medical efficacy and economic benefits of~     multidisciplinary care in patients with unexplained medical complaints and consume medical~     services frequently.~   "
108936|NCT02141555|"~     First trimester miscarriages are common. When the failed pregnancy does not pass~     spontaneously on its own, it is called a missed abortion. There are several ways in which~     missed abortions are managed, one of which involves administering a medication called~     misoprostol which causes uterine contractions inducing expulsion of the failed pregnancy.~     Misoprostol can be administered in multiple ways but has been traditionally inserted~     vaginally when used for management of missed abortions. Some studies have shown that some~     women are not comfortable with vaginal insertion of misoprostol and prefer oral~     administration. Buccal misoprostol is a way of administering misoprostol by having the~     patients insert the tablets of misoprostol between their gum and cheek, letting it dissolve~     for 30 minutes, then swallowing the remaining remnants. Buccal misoprostol is used safely in~     medical abortion. In fact a study by Fjerstad et al (2009), found a decrease in infection~     rate for medical abortion when misoprostol administration was switched from vaginal to buccal~     route combined with routine administration of doxycycline. The efficacy of using buccal~     misoprostol to treat missed abortions has not been studied previously to the investigators'~     knowledge. In this pilot study, investigators aim to test the hypotheses that buccal~     misoprostol is equally effective as vaginal misoprostol in the medical management of early~     pregnancy loss. As secondary outcomes, investigators suspect that buccal misoprostol may be~     associated with higher rates of gastrointestinal side effect but that patient satisfaction~     will remain equally as high for buccal misoprostol as for vaginal misoprostol.~   "
108937|NCT02141542|"~     This is an open label, phase I trial, testing the combination of Tremelimumab and MEDI3617 in~     patients with metastatic melanoma.~   "
108938|NCT02141529|"~     The purpose of this study is to determine whether bipolar intraarticular pulsed~     radiofrequency method has a superiority to unipolar mode in the treatment of chronic knee~     pain.~   "
108939|NCT02141516|"~     The study aims at evaluating the safety and immunogenicity of rMenB+OMV NZ when administered~     to subjects from 2 to 17 years of age with increased risk of meningococcal disease because~     either of primary or secondary complement deficiencies or of asplenia or splenic dysfunction.~     A group of healthy age-matched subjects will be enrolled to serve as a descriptive control~     for immunogenicity and safety.~   "
108940|NCT02141503|"~     Background:~      - Alpha-mannosidosis is a rare inherited disorder. It causes problems in many organs and~     tissues of the body. It can occur in children and adults. Because there is no treatment for~     this disease, researchers want to find out more about it.~      Objective:~      - To learn more about Alpha-mannosidosis.~      Eligibility:~      - People ages 5-60 with Alpha-mannosidosis.~      Design:~        -  Participants will be recruited from patient support organizations and medical genetics~          clinics.~        -  Participants will have 3 study visits, about once a year. A final evaluation will be~          made after 3 years.~        -  Participants will have a medical history and a physical exam.~        -  Blood samples and a urine sample will be collected.~        -  Cerebrospinal fluid will be collected. A small area of the lower back will be numbed~          with medicine. A thin needle will be inserted between the spine bones. About 2~          tablespoons of spinal fluid will be removed.~        -  Brain magnetic resonance spectroscopy (MRS) scans will be done at each visit. MRS uses a~          strong magnetic field and radio waves to take pictures of chemicals in the brain with a~          scanner. The participant will lie on a table that can slide in and out of the cylinder.~          While in the scanner the participant will hear loud knocking noises. They will get~          earplugs or earmuffs to muffle the sound. Medicines might be used to keep the~          participant asleep during the MRS.~        -  Participants will have a skin biopsy at the first visit only. A small area of the~          participant s skin will be numbed. A small circle of skin will be removed with a biopsy~          tool.~   "
112510|NCT02094781|"~     The purpose of this study was to evaluate the effect of combined whey protein and creatine~     supplement, as compared with whey protein supplement alone, on change in upper and lower body~     strength.~   "
108941|NCT02141490|"~     Background:~      People with prostate, bladder, or kidney cancer often have their cancer spread (metastasize)~     to lymph nodes. It is important for your doctor to know if this has occurred but currently it~     can be hard to determine if this has occurred on standard imaging studies like CT or MRI.~     This study uses an agent called Ferumoxytol to identify lymph nodes that might be involved by~     cancer.~      Objective:~      - To see how well Ferumoxytol can detect lymph node metastases in patients with prostate,~     bladder, or kidney cancer.~      Eligibility:~      -Adults over age 18 with prostate, bladder, or kidney cancer with lymph node involvement.~      Design:~        -  Participants will be screened with a medical history.~        -  Participants will have blood drawn and a physical exam. Their vital signs will be~          measured. They will answer questions about their health and current medications.~        -  Participants should not have a history of iron overload or have an allergy to~          Ferumoxytol.~        -  Participants will have a magnetic resonance imaging (MRI) scan. The scanner is a metal~          cylinder with a strong magnetic field. Participants will lie on a table that slides in~          and out of the scanner. They will have a standard sensor, known as a coil, wrapped~          around their abdomen to improve the scan. This is like a small blanket with wiring~          inside. Participants will need to lie still on the scanning table for about 1 hour.~        -  Participants will have an ultrasound. This uses harmless sound waves to provide pictures~          of organs or tissues inside the body.~        -  Participants will receive an injection of Ferumoxytol through an intravenous line. A~          very thin plastic tube will be inserted into a vein in order to inject the agent.~        -  Participants will have another MRI and ultrasound 24 and 48 hours after injection.~        -  The study will follow participants medical course for at least 1 year.~   "
108942|NCT02141477|"~     This clinical research study is made up of 2 phases. The goal of Phase 1 of the study is to~     test the safety of the combination of omacetaxine and decitabine and to find the best dose to~     give to future patients. The goal of Phase 2 of the study is to learn if this dose can help~     to control AML and/or MDS. The safety will then continue to be studied.~   "
108943|NCT02141464|"~     Ivacaftor is a novel, FDA approved new therapy that addresses Cystic fibrosis transmembrane~     conductance regulator (CFTR) dysfunctions in subjects with Cystic fibrosis (CF) and gating~     mutations.~      The primary aim is to determine the mechanism(s) for weight gain in participants whom~     Ivacaftor treatment was initiated based on clinical indications by CF Care Team. This~     longitudinal study will assess in detail energy expenditure, weight gain, body composition,~     and lung function in 24 subjects ≥6 years old with CF with a gating mutation before treatment~     and after three months treatment with Ivacaftor. All subjects will be seen at the Children's~     Hospital of Philadelphia's Clinical Translational Research Center.~   "
108944|NCT02141451|"~     This is a single institution phase I/II study using an ADAM17 inhibitor (INCB7839) with~     rituximab as consolidation therapy after an autologous hematopoietic cell transplant (HCT)~     for patients with diffuse large B cell lymphoma (DLBCL). The study consists of two phases.~     The dose finding phase is a modified version of a phase I trial and the extended phase is a~     modified version of a phase II trial.~   "
108945|NCT02141438|"~     Observational study in the routine clinical practice setting to evaluate the short and long~     term safety profile of Radium-223 in metastatic castration resistant prostate cancer patients~     and to evaluate the risk of developing second primary cancers.~   "
108946|NCT02141425|"~     The purpose of this study is to assess the safety, tolerability and pharmacokinetics of~     single ascending doses of ASP015K.~   "
108947|NCT02141412|"~     In a prospective randomized clinical trial involving adult patients undergoing elective~     surgery under general anesthesia, the investigators will enroll 216 patients, and evaluate 3~     doses of prophylactic dexmedetomidine as a means to reduce postoperative shivering and~     quality of emergence from anesthesia versus placebo.~   "
108948|NCT02141399|"~     This is a 52-week open-label study to evaluate the safety and tolerability of ALKS 5461.~   "
108949|NCT02141386|"~     Cognitive impairment remains a major disability for individuals with multiple sclerosis (MS).~     The primary objective of this study is to evaluate the efficacy for treating MS-associated~     cognitive deficits using a unique computer-based plasticity-based and adaptive cognitive~     remediation treatment (PACR) compared to a computer-based control. This novel cognitive~     remediation approach has led to striking improvements in cognitive functioning in other~     disorders (schizophrenia, traumatic brain injury, aging, and dementia) but has never been~     applied to individuals with MS. The investigators will enroll 136 MS participants who will be~     randomized in a 2:1 pattern to complete either the treatment or control condition for 60~     hours across a 12-week treatment period. Both the treatment and control conditions will be~     accessed remotely by the subjects from a study-provided laptop computer. Study outcomes will~     include program compliance, performance on study tasks and neuropsychological measures,~     quality of life and functional status. Given the success of this program with other disorders~     and strong preliminary data from our feasibility study, the investigators believe PACR is an~     exciting untapped opportunity to improve cognition in individuals with MS.~   "
108950|NCT02141373|"~     Glubran 2 as a surgical glue maybe effective in reducing seroma formation post axillary~     dissection in breast cancer patients.~   "
108951|NCT02141360|"~     This hypothesis-generating feasibility study compares mTBI Patients and Controls using~     advanced MRI Applications.~   "
108952|NCT02141347|"~     A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, PK and~     Preliminary Anti-tumor Activity when given as a monotherapy of Tremelimumab or Tremelimumab~     in combination with MEDI4736 in Japanese Patients with Advanced Solid Malignancies, and when~     given as a monotherapy of tremelimumab in Second- or Third-line Treatment of Japanese~     Subjects with Unresectable Pleural or Peritoneal Malignant Mesothelioma~   "
108953|NCT02141321|"~     The aim of the work is to evaluate the efficacy of the sub lingual prostaglandin E1 synthetic~     analogue (misoprostol) before IUD insertion to facilitate the procedure in patients delivered~     before only by cesarean section.~   "
108954|NCT02141308|"~     This study will evaluate the total blood flow in the retina and choroid (structures in the~     back of the eye) by Doppler optical coherence tomography (OCT) and OCT angiography.~     Angiography is mapping of the blood vessels.~      The purpose of measuring blood flow in the retina and choroid is to 1.) determine if rare~     diseases in these structures causes a change in blood flow compared to healthy eyes and 2.)~     find out if areas of changed blood flow line up with areas of damage that appear on~     conventional testing.~   "
108985|NCT02140905|"~     The study has two objectives based on the intended-use measurements and populations described~     above. The first objective is to show that relative changes in impedance as measured by the~     test device (ΔSFI) are strongly correlated with the amount of fluid removed during dialysis~     (ΔF) for subjects with ESRD and possibly Heart Failure.~      The second objective is to demonstrate correlation between ΔSFI and relative changes in~     impedance (ΔZ) as measured by the reference device.~   "
125320|NCT01927120|"~     IL-2 add-back post allogeneic hematopoietic stem cell transplant (HSCT), combined with~     Sirolimus (SIR), Tacrolimus (TAC) will optimize Treg reconstitution and prevent graft versus~     host disease (GVHD).~   "
108955|NCT02141295|"~     This is a Phase 2 multicenter, randomized, parallel arms, double-blind study of vanucizumab~     to evaluate the efficacy and safety of vanucizumab in combination with oxaliplatin, folinic~     acid, and 5-fluorouracil (5-FU) (mFOLFOX-6) versus bevacizumab (Avastin) + mFOLFOX-6 in~     participants with previously untreated metastatic colorectal cancer (mCRC). The study~     consists of 2 parts: a safety run-in open-label, single-arm part (Part 1) and a randomized,~     parallel-arms, double-blind part (Part 2). During Part 1 at least 6 eligible participants~     will receive 2000 milligrams (mg) vanucizumab every 2 weeks + mFOLFOX-6 in order to confirm~     the dose and schedule that will be used in Part 2. In Part 2, all eligible participants will~     be randomized in a ratio of 1:1 to receive either mFOLFOX-6 + vanucizumab or mFOLFOX-6 +~     bevacizumab. Study treatment (induction and maintenance) will be given on Day 1 of each~     14-day cycle. Induction therapy will consist of up to 8 cycles of mFOLFOX-6 plus either~     bevacizumab or vanucizumab. Maintenance therapy will consist of 5-fluorouracil and folinic~     acid plus either vanucizumab or bevacizumab for up to 24 months or until disease progression,~     unacceptable toxicity, Investigator decision or consent withdrawal, whichever occurs first.~   "
108956|NCT02141282|"~     This is an open-label, non-randomized, multicenter, Phase 2 study evaluating the efficacy and~     safety of ABT-199 in approximately 120 subjects with relapsed or refractory CLL after B-cell~     receptor signaling pathway inhibitors (BCR PI) treatment.~   "
108957|NCT02141269|"~     A new hand held pocket echo device (GE Vscan) has now become available to clinicians, with~     limited data available comparing the effectiveness of this device as a screening tool when~     compared to traditional transthoracic echocardiography (TTE).~      The investigators are evaluating the effectiveness of this hand-held echo (HHE) device in~     detecting cardiac pathology in a both an inpatient and outpatient clinical setting as~     compared to a comprehensive TTE evaluation.~   "
108958|NCT02141256|"~     The objective of this study is to investigate whether a protein-enriched daily menu is~     acceptable and effective in increasing protein intake in elderly in a residential care home~     up to an intake of 1,2 gram/ kg body weight per day.~      The investigators hypothesise that when elderly eat 2 slices of bread, 1 portion of juice and~     1 portion of soup each day, the protein intake can be increased by at least 20 grams/day. On~     average this can lead to an intake of 1,2 gram/ kg body weight per day.~   "
108959|NCT02141243|"~     We are proposing to conduct a randomized, controlled trial of newborns in the maternal infant~     care areas at Tampa General Hospital. Participants who are determined eligible for the study~     (classified to have ankyloglossia via the HATLFF and either a Class III or IV maxillary~     labial frenum) will be randomly assigned to one of two groups: Group A or Group B. Group A~     will receive a sham procedure for intervention #1 and a lingual frenotomy procedure for~     intervention #2. Group B will receive a lingual frenotomy procedure for intervention #1 and a~     sham procedure for intervention #2. Newborns that continue to have difficulty with~     breastfeeding after both interventions will undergo intervention #3, a labial frenotomy, and~     breastfeeding will be monitored afterwards.~   "
108960|NCT02141230|"~     Following results from the first survey that forms part of the EU RMP for Alli® (RMP survey~     1; WEUSRTP3350), several amendments to the information included on the pack carton for Alli®~     (orlistat 60 mg) were recommended. The main finding from RMP survey 1 was that a large~     proportion of Alli® users had a body mass index (BMI) less than (<)28 kg/m2 . (Note: the~     European indication for Alli® is adults 18 years and older with a BMI<28 kg/m2.) The~     proportion of respondents overall who reported possible contraindications to Alli® use was~     relatively low. The following changes to the pack labeling were agreed and have been~     implemented: : (1) a statement, highlighting the product is only for those with a BMI of 28~     or above was added to the front of the pack; (2) wording of the BMI statement on the back of~     the pack was strengthened; (3) contraindications were highlighted in bold text; (4) the~     statement that Alli® is not for use by those under 18 years of age was modified for clarity.~     In addition, a pharmacy reminder card was made available to retail pharmacists to improve~     awareness of the prescribing information for Alli®. The survey will assess whether compliance~     with the authorized indication and contraindications among purchasers of Alli® has been~     improved after one year of marketing the revised pack labeling.~   "
108961|NCT02141217|"~     In clinical practice, amoxicillin + clavulanic acid is widely used in the treatment of~     odontogenic infection. Therefore, this study is designed to generate data to support its use~     by demonstrating efficacy, safety and tolerability in comparison with clindamycin in subjects~     with acute odontogenic infections with or without abscess. This will be a two-arm, parallel,~     comparative, observer blind, randomised study to assess efficacy, safety and tolerability of~     amoxicillin + clavulanic acid (875mg/125mg) in comparison with clindamycin (150mg)~     administered for 5-7 days in subjects with acute odontogenic infections with or without~     abscess. The study will be performed in adult subjects both male and female ≥18 years of age~     who present with acute odontogenic infections. A total of 472 subjects will be randomized in~     1:1 ratio, i.e. 236 subjects in each treatment arm. The treatment duration of the study will~     be at least 5 days or maximum 7 days depending upon the treatment response. Subjects will be~     assessed on Day 5 and if Investigator feels the need of continuing the treatment at Day 5~     then treatment will be continued till Day 7. For subjects who do not show treatment response~     on Day 5, assessments will be performed on Day 7.~   "
108962|NCT02141204|"~     The purpose of this study is to evaluate and compare immunogenicity, reactogenicity and~     safety of two formulations (liquid vs. lyophilised) of GSK Biologicals' HRV vaccine when~     administered as two doses in healthy infants aged ≥ 6 weeks.~   "
108963|NCT02141191|"~     The primary objective of this study is to determine whether a single overnight, eight-hour~     administration of a 7% NaCl solution delivered by the Parion Sciences transnasal Pulmonary~     Aerosol Delivery (tPAD) device has a significant effect on mucociliary clearance in subjects~     with cystic fibrosis, as compared to no treatment. This study will be conducted at the~     University of Pittsburgh Medical Center.~   "
109032|NCT02140294|"~     Patient found to be malnourished after the nutritional evaluation would be randomized in the~     two groups of the study. The control group would receive standard nutritional counseling from~     a trained dietician where as those in the intervention group would be given 120 gm of a~     polymeric nutritional supplement providing around 500 Kcal per day over and above the~     standard nutritional counseling from a trained dietician. Both the groups would receive~     standard medical treatment. The polymeric nutrient supplement would be taken by the patients~     in this arm for a period of 6 months.~   "
108964|NCT02141178|"~     Carpal tunnel syndrome is one of the most common surgeries performed per year in the United~     States, accounting for over 600,000 surgeries. The procedure is commonly performed under~     light sedation and local anesthesia. Bupivicaine, a long acting local anesthetic, has been~     used to allow extended pain relief for 8-10 hours after carpal tunnel release. Exparel, a~     liposomal bupivicaine formulation, has been documented to provide pain relief for up to 72~     hours post-operatively. By decreasing post-operative pain through the use of a long-acting~     local anesthetic, the use of narcotic pain medications may be decreased and patient~     satisfaction scores may increase.~      The purpose of this study is to prospectively compare bupivicaine and liposomal bupivicaine~     with respect to post-operative pain control, narcotic usage, and patient satisfaction after~     carpal tunnel release.~   "
108965|NCT02141165|"~     Primary objectives: To determine the efficacy and cost-effectiveness of a management program~     for patients with obstructive sleep apnea syndrome (OSAS) carried out in primary or~     specialist healthcare. In the primary arm, the diagnosis and therapeutic decision will be~     made by means of a domiciliary nasal pressure (DNP) channel and oximetry while the specialist~     healthcare arm will use polysomnography (PSG) in a hospital. Patients with an~     intermediate-high suspicion of OSAS will be included, taking as primary variables the Epworth~     scale, for efficacy, and the Epworth scale and EuroQol 5D, for cost-effectiveness.~      Secondary objectives: efficacy of the two SAHS management programs according to the following~     secondary variables: a) quality-of-life tests: FOSQ questionnaire, SF36 and analogical~     wellbeing scale, b) adherence to and compliance with the treatment.~   "
108966|NCT02141152|"~     The next generation of personalized medical treatment according to the type of personal~     genetic information are evolving rapidly. The genome analysis needs systematic infra and~     database based on personal genetic information Therefore, a big data of genome-clinical~     information is important.~      To determine the feasibility of the use of tumor's molecular profiling and targeted therapies~     in the treatment of advanced cancer and to determine the clinical outcome(PFS, duration of~     response and overall survival) of patients with advanced cancer, the investigators are going~     to take a fresh tissue of patients and process molecular profiling and receive molecular~     profile directed treatments.~   "
108967|NCT02141139|"~     It is increasingly recognized the NSAIDS (nonsteroidal antiinflammatory drug) might prevent~     the several cancers. In breast cancer, the role of NSAIDS (nonsteroidal antiinflammatory~     drug) has been suggested.However, there was no consistent results. surgery is main cause of~     inflammation for cancer patients. Therefore, we want to know the association between~     prevention of perioperative inflammation with NSAIDS and breast cancer outcomes.~   "
108968|NCT02141126|"~     The primary aim of this research is to evaluate changes in lower limb strength and physical~     function following six weeks of resistance training and routine physiotherapy versus a~     control group of routine physiotherapy only in an older inpatient population.~   "
108969|NCT02141113|"~     This is considered an investigator-initiated clinical research trial, which means that your~     study doctor is researching a particular medication (in this case a medication that is~     currently FDA- approved) for the treatment of AD/HD in individuals ages 6-17. The medication~     is guanfacine hydrochloride.~      The hypothesis is that this medication could be used in adults with Attention~     Deficit/Hyperactivity Disorder who have not received satisfactory results with their current~     stimulant ADHD medication. The study drug is investigational for use in adults.~     Investigational means it has not been approved by the U.S. Food and Drug Administration (FDA)~     for use in adults.~   "
108970|NCT02141100|"~     The purpose of this phase 1-2 study is to explore the applicability of supplementing standard~     methotrexate/6-mercaptopurine (MTX/6MP) maintenance therapy of children with non-Hodgkin~     lymphoma with 6-thioguanine (6TG).~      The investigators hypothesize that addition of 6TG to 6MP-based maintenance therapy of~     patients with high TPMT activity will mimic the more favourable thiopurine metabolism of~     patients with low TPMT activity and ultimately reduce relapse rates.~   "
108971|NCT02141087|"~     This is an open label multi-center program to allow patients in the US with IPF access to~     treatment with pirfenidone.~   "
108972|NCT02141074|"~     This trial is conducted globally. The aim of the trial is to investigate the safety and~     efficacy of nonacog beta pegol (N9-GP) in previously untreated patients with Haemophilia B.~   "
108973|NCT02141061|"~     This study is a double-blind crossover study in female healthy volunteers to compare the~     pharmacokinetics and safety of a single dose each of two different formulations of Proellex~     for oral administration. Each formulation will be designated as either Treatment A or~     Treatment B. A total of 12 subjects who meet the eligibility criteria will be randomized to~     receive either Treatment A or Treatment B as their first assigned treatment. After a 7-day~     washout period subjects will receive the alternative treatment. On the day of each treatment~     subjects will remain in the clinic overnight and undergo 72-hour pharmacokinetic assessment~     at the following time points: 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48 and 72 hours after~     administration of study drug.~   "
108974|NCT02141048|"~     The purpose of this study is to determine whether the Parent Centre's Positive Parenting~     Skills Training (PPST), a parenting programme being delivered in South Africa, is effective~     in improving parenting, and child behaviour related outcomes.~   "
108975|NCT02141035|"~     Study Hypothesis: Acetyl-l-carnitine increases nerve regeneration in patients with severe~     carpal tunnel syndrome.~      Carpal tunnel syndrome (CTS) is common, affecting almost 3% of the general population. In~     severe cases, nerve regeneration and functional recovery are incomplete even with surgery.~     The goal of this pilot project is to test a potentially promising medication,~     acetyl-l-carnitine (ALCAR). We will use a randomized, double blinded, placebo controlled~     study design. Along with surgery, those in the treatment group will also receive ALCAR while~     the other half in the control group will be given placebo. To gauge the effects of ALCAR, we~     will compare motor and sensory nerve growth as well as functional outcomes. The data from~     this study will provide crucial information when designing a full scale clinical trial. If~     successful, this will represent an important first step in finding a novel treatment to~     improve functional outcomes in patients with severe CTS.~   "
108976|NCT02141022|"~     This study is investigating the efficacy of computer-based cognitive exercises as a means of~     cognitive remediation in patients with Multiple Sclerosis (MS) who are beginning the disease~     modifying pharmacotherapy Gileyna.~   "
109033|NCT02140281|"~     A study to evaluate the effect of repeated oral doses of AZD1722 on the pharmacokinetics of~     Cefadroxil~   "
108977|NCT02141009|"~     Community acquired pneumonia (CAP) is an important health problem with significant morbidity,~     mortality and cost. The most identified pathogen in CAP is Streptococcus pneumoniae. This was~     also the causative agent most frequently found in the Ovidius and Triple-P study, two~     consecutive clinical trials initiated by the St. Antonius Hospital Nieuwegein. Diagnosis of~     pneumococcal pneumonia can be based on positive blood cultures, sputum cultures, urine~     antigen testing or a serotype specific antibody response. When pneumococcal pneumonia is~     diagnosed by a positive culture, a matching serotype specific antibody response is expected.~     However not all patients in the Ovidius and Triple-P study with a culture proven pneumococcal~     pneumonia showed an antibody response against the infecting pneumococcal serotype. Patients~     who survived pneumococcal pneumonia are considered as a high-risk population for pneumococcal~     disease in the future. Possibly these patients have an impaired immune response against S.~     pneumoniae. In this study, pneumococcal vaccination of patients with S. pneumoniae CAP in the~     past enables investigating their immune response after vaccination compared to patients with~     CAP due another causative agent. Furthermore this study provides information to determine if~     there is a difference in vaccination response between pneumococcal pneumonia patients who had~     a culture matching serotype specific antibody response and between pneumococcal pneumonia~     patients who failed to elicit this response previously. Possibly these latter patients had a~     temporarily low titre due to the infection but another explanation is that there might be a~     structurally impaired immune response against S. pneumoniae or certain serotypes.~   "
108978|NCT02140996|"~     In epithelial cancer, MUC-1(mucin-1) overexpression is thought to disrupt E-cadherin~     function, leading to anchorage-independent tumor cell growth and metastases. Elevated levels~     of MUC-1 expression have been found in patients with epithelial cancers of breast, ovarian,~     colon and lung. Furthermore, overexpression of MUC-1 is independently correlated with adverse~     clinical phenotypes, metastases and resistance to chemotherapy. In animal models, suppressing~     the expression of MUC-1 reduces the rates of growth and metastasis and increases the~     sensitivity of the cancer to chemotherapy-induced cell death.~      In this study, an adenoviral Ad-sig-hMUC-1/ecdCD40L vector encoding a fusion protein in which~     the hMUC-1 epithelial antigen is attached to the CD40L (CD40 ligand). The preclinical results~     have also shown that two subcutaneous Ad-sig-hMUC-1/ecdCD40L vector injections can induce~     immunity through activation of dendritic cells and promotion of antigen specific B cells or~     antigen specific CD8 effector T cells which suppresses the growth of hMUC-1 tumor cells in~     100% of the vaccinated mice without Interleukin (IL) 2 stimulation being required, this~     suggests that the Ad-sig-hMUC-1/ecdCD40L vector prime-hMUC-1/ecdCD40L protein boost has the~     potential to be an effective vaccine in epithelial tumors. Therefore, the safety and~     tolerability of the Ad-sig-hMUC-1/ecdCD40L vector vaccine will be tested in this phase I~     non-randomized open label dose escalation trial for men or women with metastatic or recurrent~     epithelial cancers of the lung, breast, ovary, prostate and colon.~   "
108979|NCT02140983|"~     The purpose of this study is to evaluate the effects of liraglutide on the memory and~     attention of people with insulin resistance. Liraglutide is a medication that makes the body~     more sensitive to insulin, and therefore may allow it to manage sugar more effectively.~      The investigators are looking specifically at a region of the brain that is associated with~     memory and attention, called the hippocampus, in order to see whether treatment this~     treatment will change performance on memory and attention tasks. The investigators are also~     taking an MRI of the brain to see whether there are changes to the size and shape of the~     hippocampus after treatment.~      All subjects in this study will be 50-70 years old and have pre- diabetes. Half of all~     subjects will have a family history of dementia, while the other half will not.~   "
108980|NCT02140970|"~     This study plans to learn more about whether ibuprofen can reduce pain after removal of a~     ureteral stent more than a placebo. Some patients experience pain after removal of a ureteral~     stent. The investigators plan to learn how often this occurs and whether it can be prevented.~      The investigators hypothesize that children who have a temporary, indwelling ureteral stent~     will experience a significantly less post-operative pain if given a non-steroidal~     anti-inflammatory (NSAID) prior to removal of the ureteral stent when compared to placebo.~     The investigators hypothesize that the incidence of severe post-stent removal pain is similar~     to an adult population.~   "
108981|NCT02140957|"~     Observational studies support an association between bottle feeding beyond 15 to 18 months of~     age and lower socioeconomic status, excessive milk intake, dental caries, iron deficiency,~     behavioral issues and obesity. Yet many parents, particularly those from low socioeconomic~     households, choose to feed their children by bottle much beyond this age. Recognizing the~     need for further educational interventions for bottle feeding, the TARGet Kids! Research~     Collaboration recently developed a 5-minute bottle weaning educational intervention for the 9~     month well-child visit. We undertook a pragmatic randomized controlled trial to evaluate its~     effectiveness involving 251 children recruited through TARGet Kids! (PMID: 20624802) The goal~     was to determine whether an office-based, educational intervention for parents of 9-month-old~     children could reduce bottle use and iron depletion at 2 years of age.~   "
108982|NCT02140944|"~     IMPAACT P1107 will describe the outcomes of HIV-infected persons, ages 12 months and older,~     who undergo transplantation with CCR5Δ32 cord blood stem cells for treatment of cancer,~     hematopoietic disease, or other underlying disease.~   "
108983|NCT02140931|"~     A randomized, double-blind placebo controlled study to determine the safety and efficacy of~     Angiogenic Cell Precursors (ACPs) in relieving symptoms of Critical Limb Ischemia in patients~     treated with standard of care and with no surgical revascularization option. It is assumed~     that the ACP-treated group will have a lower amputation and death rate as compared to the~     placebo group. Other hemodynamic, imaging and clinical parameters will also be compared~     between the two groups. Quality of life assessments will also be performed.~   "
108984|NCT02140918|"~     Fludrocortisone, in association with hydrocortisone, has demonstrated an improvement in~     survival in septic shock patients with relative adrenal insufficiency. However, the utility~     of low doses of steroids and in particular of mineralocorticoids in septic shock is still~     discussed.~      The purpose of the investigators study is to investigate the effects of 3 increasing doses of~     fludrocortisone (100 μg, 200 μg, 400 μg) in order to determine which dose allows the best~     pressor response to phenylephrine in healthy volunteers, and simultaneously assess their~     respective hemodynamic and biological effects.~   "
108986|NCT02140892|"~     One of the main goals of the respiratory physical therapy is to help people who are suffering~     from accumulating of secretions in their airways and lungs.~      Chronic Obstructive Pulmonary Disease (COPD) patients are often hospitalized with an Acute~     Exacerbation of their medical condition.~      Those patients usually get only the standard medical care during the acute phase and don't~     get respiratory physical therapy treatment.~      The study's main aim is to investigate if respiratory physical therapy treatment in addition~     to standard medical care during the acute phase, can improve the respiratory and medical~     condition and reduce hospitalization stay.~      In order to do so we will compare three groups of COPD patients during acute exacerbation;~     two groups will get one out of two respiratory physical therapy techniques; manually or~     Intrapulmonary Percussive Ventilator (IPV) in addition to standard medical care and the third~     group will get standard medical care alone.~   "
108987|NCT02140879|"~     This research study will examine how diet during pregnancy can benefit pregnancy and~     pregnancy outcome, such as your baby's weight. More specifically, the investigators will~     study the effects of two different food oils/fats that are commonly consumed to determine if~     one is more effective in limiting maternal inflammation during pregnancy. You are being asked~     to take part in this study because it will help us update and make the best dietary~     recommendations for pregnant women and women of child bearing ages.~   "
108988|NCT02140866|"~     The study examines whether hand exercise therapy as an add on to a compensatory intervention~     program focused on joint protection, assistive devices and alternative methods of doing will~     improve the performance of ADL tasks requiring hand function in patients with rheumatoid~     arthritis (RA).~   "
108989|NCT02140853|"~     Objective~        1. To evaluate the impact of MDR pathogen on prognosis and therapy cost;~        2. To compare the efficacy of different antibiotics in treatment of infection caused by MDR~          pathogens;~        3. To evaluate the risk factors of MDR pathogens infection;~        4. To evaluate the distribution and characteristics of MDR pathogens;~        5. To investigate the proportion of MDR isolates to construct systematic database.~   "
108990|NCT02140840|"~     The purpose of this study is to evaluate the overall response rate of Trametinib when~     administered orally to patients with relapsed or refractory multiple myeloma~   "
108991|NCT02140827|"~     Colonoscopy is the gold standard in the diagnosis of colorectal disease. The success of~     colonoscopy depends on high-quality bowel preparation by patients. Inadequate bowel cleansing~     reduces the cecal intubation rate, and the polyp detection rate (PDR). It also increases~     costs, mostly due to repeated procedures. The quality of bowel cleansing has remained~     suboptimal even though numerous different products and regimens have been tested and compared~     in no fewer than six meta-analyses. Therefore, a completely different approach to improve~     bowel cleansing is welcome.~      Here the investigators assume that instant messaging program (Wechat) delivery the detail and~     FAQ (Frequently Asked Questions) of bowel preparation instructions would improve the quality~     of the bowel preparation. The Wechat program has some advantages, 1. Wechat supports over 400~     million users, nearly half of the mobile subscribers population in China; 2. Wechat provided~     a real time communications including voice messages, pictures and text exchange timely;~     3.Compare with telephone, Wechat is economical of both time and money; 4. Compare with bowel~     preparation instructional software and litera or cartoon educational booklet, Wechat is more~     interactive and responsive.~   "
108992|NCT02140814|"~     The goal of this pilot study is to evaluate the feasibility of administering niacinamide to~     patients with autosomal dominant polycystic kidney disease, to develop methods to assess the~     biological efficacy of niacinamide, and to perform a preliminary exploration of its clinical~     effect on kidney cyst growth and kidney function.~   "
108993|NCT02140801|"~     A number of 352 patients scheduled for elective percutaneous coronary intervention (PCI) with~     a native coronary stenosis suitable for DES implantation and OCT imaging are openly~     randomized 1:1 to either BRILINTA™ (ticagrelor) or Plavix® (clopidogrel bisulfate).~   "
108994|NCT02140788|"~     One purpose of this study is to test whether adding metformin will limit some of the unwanted~     effects of clozapine, compared to not adding metformin. Metformin is a medication that is~     approved by the United States Food and Drug Administration (FDA) for the treatment of type-2~     diabetes. Studies have found that people with type-2 diabetes often lose some weight when~     they take metformin, however the FDA has not approved metformin for weight loss, so for this~     study the use of metformin is investigational. This study will test whether metformin can~     help people with schizophrenia or schizoaffective disorders lose weight.~      Another purpose of this study is to test whether adding fish oil will improve the benefit of~     clozapine and/or limit some of the unwanted effects of clozapine, compared to not adding fish~     oil. Fish oil is a medication used to reduce levels of some fats (triglycerides) in blood.~     Some studies have found that adding fish oil reduces psychosis (voices, suspiciousness).~     However the FDA has not approved fish oil for reducing psychosis, so for this study the use~     of fish oil is investigational. This study will test whether fish oil can help people with~     schizophrenia or schizoaffective disorders have less psychosis. Fish oil is not an~     antipsychotic medication.~   "
108995|NCT02140775|"~     The current study is a randomized clinical trial comparing Behavioral Activation counseling~     with supportive counseling for HIV+ participants presenting with clinically significant~     fatigue whose energy has improved with armodafinil, who have the goal of returning to work or~     vocational training but have not done so on their own. A second cohort of HIV+ participants~     without significant fatigue at baseline, but who also have the goal of returning to work,~     will also be randomized to either Behavioral Activation counseling or supportive counseling.~     In both cohorts, the primary outcome is level of success regarding an employment related~     goal.~   "
108996|NCT02140762|"~     Evaluate the effectiveness of 2 doses of MenABCWY vaccine in adolescents compared to a single~     dose of MenACWY vaccine.~   "
109034|NCT02140268|"~     A Study to Evaluate the Effects of oral repeated doses of AZD1722 on the Pharmacokinetics of~     Oral Midazolam in Healthy Volunteers~   "
109035|NCT02140255|"~     IMPAACT P1115 will explore the effects of early intensive antiretroviral therapy (ART) on~     achieving HIV remission (HIV RNA below the limit of detection of the assay) among~     HIV-infected infants.~   "
112526|NCT02094573|"~     The purpose of this study is to evaluate the efficacy and safety of two different dosing~     regimens of brigatinib (AP26113) in participants with ALK-positive locally advanced or~     metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on therapy with~     crizotinib.~   "
108997|NCT02140749|"~     Rationale: The dietary short-chain fructooligosaccharides have been shown to increase fecal~     bacterial mass and fermentation metabolites which might stimulate gut motility. Therefore,~     these dietary non-digestible carbohydrates might relieve functional constipation.~      Objective: Study the effect of short-chain fructooligosaccharides on functional constipation.~      Study design: A 16-week, randomized, placebo-controlled, double-blind cross-over trial with~     intervention periods of 4 weeks with a run-in period of 4 weeks and a wash-out period of 4~     weeks.~      Study population: Human subjects with functional constipation according to ROMEIII criteria~     (total n=120; male and female; 18-75 yr).~      Intervention: Placebo and one out of 3 dosages of short-chain fructo-oligosaccharides,~     (Degree of Polymerisation of 3-5; 2, 4 and 8 g/day) for 4 weeks. scFOS will be given as oral~     chews.~      Main study parameters: The primary parameter is the number of complete bowel movements per~     day in subjects with functional constipation according to Rome III criteria. Secondary~     outcomes are Stool consistency (Bristol Stool Scale), Stool frequency, Severity of symptoms~     (Constipation Scoring System; CSS) and Quality of Life (Patient Assessment of Constipation~     Quality of Life; PAC-QoL).~   "
108998|NCT02140736|"~     The main aim of this study is to observe correction of the hemoglobin level in the patients~     under chemotherapy, treated with epoetin alfa biosimilar and presenting with a solid tumor or~     a lymphoma or a myeloma.~   "
108999|NCT02140723|"~     Background:~      Meta-analyses of large randomized trials proved the superiority of preoperative short course~     radiation and surgery, as compared with surgery alone. Short course radiation results in a~     50% reduction in terms of local relapse in stage II and III rectal cancer patients. Patients~     with complete pathological remission additionally show a significant survival benefit.~     Complete pathological remission (pCR) occurs in 8% after preoperative radiation and in >16%~     if the interval between radiation and surgery is at least 8 weeks.~      It is generally accepted that mutations in the TP53 gene represent a crucial defect in the~     apoptosis pathway. Radiation therapy is suggested to act via induction of apoptosis in~     irradiated cells. Therefore, it is expected that a defect in the TP53 gene has an effect on~     the success of radiation therapy.~      Currently available imaging tools are hardly able to diagnose response to radiation therapy~     correctly, as this does not essentially correlate with tumor size.~      Method:~      Aim of this prospective observation study is to strengthen the hypothesis that the TP53~     genotype is a promising marker to predict response to radiation therapy in rectal cancer~     patients. Consequently, the expected results will justify prospective, randomized~     intervention trials to obtain level of evidence I for the p53 marker hypothesis. Trial~     endpoint is downstaging and pCR rate. Tumor stage and pathological remission will be~     evaluated by MRT and pathohistology and correlated to the TP53 genotype of the diagnostic~     biopsy. Additionally, we will investigate the applicability of novel imaging modalities in~     magnet resonance tomography to monitor response to radiotherapy.~      The objective of this study is~        -  to evaluate the effect of a genetic tumor marker (TP53 genotype) on the response to~          preoperative short course radiation (in terms of downstaging and pCR rate)~        -  to evaluate the applicability of novel magnet resonance tomography imaging modalities to~          monitor response to preoperative short time radiation.~      Conclusion:~      The prospective evaluation of the potential predictive marker TP53 may bring us one-step~     closer to an individualized therapy regimen, which allows the restriction of preoperative~     radiation in rectal cancer to those patients who will benefit.~   "
109000|NCT02140710|"~     Timing of the first and last meconium stool is critical for oral feeding tolerance and proper~     gastrointestinal function. The time until premature infants pass their first meconium ranges~     from 1 hour to 27 days (median: 43 hours). Obstruction of the gastrointestinal tract by~     tenacious, sticky meconium frequently leads to gastric residuals, a distended abdomen and~     delayed food passage Recent data support the concept that complete rapid evacuation of~     meconium plays a key role in feeding tolerance . If duration to full enteral feedings is~     extended, the probability to acquire infections due to intravenous access for parenteral~     nutrition increases and hospital stay of the infant prolongates. Previously two prospective~     trials focusing on the problem of delayed meconium evacuation in preterm with different~     therapeutic pharmacological approaches were published by our group. None of the applied~     therapies appeared to be effective or had a beneficial effect- quite the contrary one agent~     (Gastrografin) was supposed to have severe negative side effects. Therefore we were looking~     for an alternative, non-invasive, holistic solution for the problem of delayed meconium~     excretion. Osteopathic treatment with the emphasis on the relationship of the structural and~     functional integrity of the body and with its variety of therapeutic manual techniques seemed~     to be remedy. Treating the abdomen of premature infants with visceral osteopathic techniques~     might be more effective to mobilize meconium from small bowel and deep parts of the colon.~     Therefore we hypothesized that repeated visceral osteopathic treatment accelerates meconium~     evacuation in premature infants, and thereby enhances feeding tolerance in this population.~   "
109001|NCT02140697|"~     Obesity is a major health issue worldwide; there is a constant raise in obesity related death~     each year. In vitro and animal studies elucidated Hippophae rhamnoides L. Leaf Extract as a~     novel anti-obesity agent. However, the efficacy and safety of Hippophae rhamnoides L. Leaf~     Extract supplementation on body weight regulation in humans are lacking.~   "
109002|NCT02140684|"~     This study will compare the absolute and relative effectiveness of managing real-life asthma~     with and without the use of NIOX MINO® and NIOX Flex® to measure exhaled nitric oxide (eNO)~     as a marker of underlying airway inflammation to guide appropriate management. As exhaled~     nitric oxide responds rapidly to environmental changes and can act as a marker of underlying~     inflammation it is proposed that incorporating eNO monitoring into routine asthma management~     treatment allows strategies to be more accurately tailored to the patients needs, increasing~     the probability of good asthma control.~   "
109003|NCT02140671|"~     Following on from a 10 year study conducted in Finland this study is designed to test the~     validity and sustainability of an enhanced asthma management model for the UK.~   "
109004|NCT02140658|"~     The purpose of this study is to assess the affect of multiple health education interventions~     for statins medication compliance and clinical prognosis of ischemic stroke patients at 3, 6~     and 12 months.~   "
109005|NCT02140645|"~     The objective of this study is to identify EMR-based clinical covariates and quantify their~     association with the prescribing of each specific type 2 diabetes (T2DM) medication under~     investigation. This will include an assessment of how well these covariates are captured~     through claims data proxies, and their potential to confound comparative research of T2DM~     medications.~   "
109036|NCT02140242|"~     The proposed trial will address two clinically important questions for younger patients with~     newly diagnosed acute myeloid leukemia (AML): the optimal dose of daunorubicin in induction~     therapy and the necessity of a second induction cycle in patients with a good response after~     the first induction. The primary endpoint is the rate of good responders. Secondary outcomes~     will be relapse-free survival, overall survival and minimal residual disease kinetics.~     Patients will be recruited in about 40 treatment centers of the Study Alliance Leukemia study~     group over a period of 40 months. The results will be of great clinical relevance: First, the~     study could facilitate the establishment or confirmation of the optimal daunorubicin dose.~   "
109006|NCT02140632|"~     Carpal tunnel syndrome is caused by the compression of median nerve at the wrist where it~     passes through a narrow space called carpal tunnel formed by the wrist bones, ligaments and~     tendons. The common symptoms include numbness and pain over the areas supplied by the median~     nerve namely the thumb, the index finger, the middle finger and the outer part of the ring~     finger. There can be loss of sensation, weakness or muscle atrophy in severe cases. The~     functions of the affected hands may be greatly impaired.~      Carpal tunnel syndrome is very common. It can lead to significant economic impact both to the~     affected individual and the society either by the direct treatment cost and indirectly from~     the working ability loss. Despite the vast burden, there is no consensus regarding its~     treatment so far. Surgery is generally effective and often reserved for severe cases. There~     are many nonsurgical treatment options. Local steroid injection and wrist splinting are among~     the commonest and with more evidence. Local steroid injection into the carpal tunnel can~     reduce the inflammation and swelling. Wrist splinting can maintain the wrist at its neutral~     position where the pressure at the carpal tunnel is the least. However, there are only very~     few studies comparing these two treatments directly.~      Patients complaining of finger numbness who have been confirmed to have carpal tunnel~     syndrome by nerve conduction test are invited to participate in the study. The patients who~     agreed to be recruited are asked about their basic informations and the details of the carpal~     tunnel syndrome symptoms. Their hands will be examined. They are asked to fill in a~     questionnaire specific for assessing the symptom severity and the functional status of~     patients with carpal tunnel syndrome. They will then be assigned to one of the two treatment~     groups randomly and receive the respective treatment. They need to come back for follow-up at~     one month and to fill in the questionnaire again.~      The study hypothesis is local steroid injection is more effective than wrist splinting in~     treating carpal tunnel syndrome.~   "
109007|NCT02140619|"~     The study aimed to demonstrate the relationship between secondary prevention medication~     compliance and clinical prognosis of ischemic stroke patients at 3,6,12 months~   "
109008|NCT02140606|"~     To investigate safety, tolerability of cafusertib combination with low dose cytarabine~     (LD-Ara-C) in Chinese patients with relapsed/refractory AML that are not eligible for~     conventional or intensive treatment. The dose of cafusertib will be escalated to determine~     the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) of cafusertib in~     combination with LD-Ara-C in AML patients. At the same time, pharmacokinetic characteristics~     and preliminary efficacy of cafusertib will be observed in AML patients. To determine the~     recommended dosage regimen for phase II.~   "
109009|NCT02140593|"~     The depth of neuromuscular blockade (NMB) during surgery may cause a clinical dilemma between~     optimal surgical conditions and the risk of postoperative residual blockade.~      The aim of the study is to investigate if intense NMB improves surgical conditions during~     operation in patients scheduled for elective open upper abdominal surgery.~   "
109010|NCT02140580|"~     Trial question: Does administration of exogenous surfactant using a minimally-invasive~     technique improve outcome in preterm infants 25-28 weeks gestation treated with continuous~     positive airway pressure (CPAP)? Trial hypothesis: That early surfactant administration via a~     minimally-invasive technique to preterm infants on CPAP will result in a lesser duration of~     mechanical respiratory support, and a higher incidence of survival without bronchopulmonary~     dysplasia. Trial design: Multicentre, randomised, masked, controlled trial in inborn preterm~     infants 25-28 weeks gestation, aged less than 6 hours, requiring CPAP because of respiratory~     distress, with an FiO2 of >=0.3 and CPAP pressure 5-8. Infants randomised to surfactant~     treatment receive 200 mg/kg of poractant alfa (Curosurf) administered under direct~     laryngoscopy using a surfactant instillation catheter, followed by reinstitution of CPAP.~     Controls continue on CPAP. The intervention is masked from the clinical team. Care thereafter~     is as per usual in both groups, other than the requirement to adhere to intubation criteria.~     The primary outcome is incidence of death or BPD. Secondary outcomes include incidence of~     death, major neonatal morbidities (BPD, intraventricular haemorrhage, periventricular~     leukomalacia, retinopathy of prematurity, necrotising enterocolitis), pneumothorax and patent~     ductus arteriosus; need for intubation and surfactant therapy; durations of mechanical~     respiratory support, intubation, CPAP, intubation and CPAP, high flow nasal cannula (HFNC),~     oxygen therapy, intensive care stay and hospitalisation; hospitalisation cost; applicability~     and safety of the MIST procedure; and outcome at 2 years. The sample size is 303/group,~     allowing detection of a 33% difference in the primary outcome with 90% power. The trial~     commenced at Royal Hobart Hospital December 2011 and Royal Women's Hospital during 2012, and~     will ultimately be conducted over 5 years in multiple centres internationally.~   "
109011|NCT02140567|"~     The purpose of this study is to perform a prospective evaluation of the vasovagal syncope~     prediction algorithm, called Tilt Test Analyzer, during head up tilt testing tests in one~     center in the United Kingdom.~   "
109012|NCT02140554|"~     This is a non-randomized, open label, multi-site, single dose, Phase 1 study in up to 29~     adults with Severe Sickle Cell Disease (SCD). The study will evaluate hematopoietic stem cell~     (HSC) transplantation (HSCT) using LentiGlobin BB305 Drug Product.~   "
109013|NCT02140541|"~     To explore the relationship between blood eosinophil counts, asthma exacerbations and patient~     asthma control using a large primary care based research database~   "
109014|NCT02140528|"~     This study is a case-control prospective, clinal trial to assess the safety and efficacy of~     the allogeneic adipose derived mesenchymal stem cell transplantation on the healing of recent~     tibial fracture in 40 patients.~   "
109015|NCT02140515|"~     We wanted to compare the Assisted Reproductive Technology (ART) outcomes between two~     protocols of induction of ovulation in patients with Hypogonadotropic Hypogonadism. In the~     beginning, all patients receive Recombinant Follicle Stimulating Hormone (Gonal-F) and~     Recombinant Luteinizing Hormone (Luveris). When at least one follicle reaches 14 mm in~     diameter, Luveris alone is administered for group A and both drugs Gonal-F and Luveris for~     group B. Finally Assisted Reproductive Technology (ART) results are compared between the two~     groups.~   "
109016|NCT02140502|"~     In this study, the investigators aim to establish the incidence of enteric fluoroquinolone~     resistant bacteria in a contemporary clinical cohort. This incidence will be studied by~     taking a rectal swab sample from all consenting patients coming in for prostate biopsies. The~     information gained from this study will be used to determine whether antibiotic prophylactic~     practices need to be updated in their clinic. The investigators aim to enroll 200 patients~     and patient recruitment is estimated to take place between May 2014 and August 2014. The~     study is estimated to end in May 2016.~   "
109017|NCT02140489|"~     The purpose of this study is to evaluate the drug-drug interaction between~     amlodipine/losartan and rosuvastatin in healthy male volunteers.~   "
109018|NCT02140476|"~     Bipolar sealing and cutting devices such as EnSeal® G2 Tissue Sealer are surgical instruments~     that use electrical powered diathermic energy to seal and transect tissue. These devices have~     shown high efficiency in a wide variety of open and laparoscopic general and gynecological~     surgical procedures.~      The surgical performance of the EnSeal® has shown to be comparable to that of ultrasonic~     cutting devices in several studies. However, the efficacy of this instrument and in~     particular of new instruments such as the EnSeal® G2 Tissue Sealer has not been evaluated in~     thyroid surgery.~      Our primary aim is to verify whether the EnSeal® performance is superior to the standard~     surgical technique for thyroidectomy in a randomized clinical trial on 2 different~     institutions.~   "
137615|NCT01765972|"~     The primary purpose of this clinical trial is to evaluate the eye's response to three test~     soft contact lenses as well as no lens wear, with respect to Corneal Staining.~   "
109019|NCT02140463|"~     Analysis of cell free DNA(cfDNA), unlike tissue biopsy, presents a new tool for the~     monitoring and treatment of cancer. The investigators have developed a differentiated~     sequencing assay, Digital Sequencing Technology (DST) that enables detection of rare genomic~     abnormalities with ultra high-specificity and sensitivity. The investigators assay is able to~     eliminate the error and distortion created by sample-prep and sequencing processes in~     standard NGS(next-generation sequencing ) workflows and produce near-perfect representations~     of all rare variants.~      The investigators have shown that in sequencing a comprehensive cancer panel of 80kbp in 0.1%~     cancer cell line titration samples, standard Illumina SBS(sequencing by synthesis ) generates~     many high-quality false positive variant calls in the range of 0.05-5%, while the~     investigators assay resulted in highly sensitive and completely error-free variant calls~     across the entire panel.~      This work indicates the remarkable potential of using the investigators assay in deep~     analysis of cfDNA, thereby allowing researchers and clinicians to comprehensively and~     non-invasively monitor the genetic dimension of cancer throughout the body.~   "
109020|NCT02140450|"~     To assess the effect of prophylactic antiglaucoma agents in prevention of acute intraocular~     pressure rise after intravitreal injection.~   "
109021|NCT02140437|"~     This research is designed to investigate whether the addition of fulvestrant 500mg to~     anastrozole is better than anastrozole alone as first-line endocrine therapy for advanced~     breast cancer.~   "
109022|NCT02140424|"~     This is an observation study of girls ages 10-16 years with type 1 diabetes and age- and~     race-matched controls. The investigators will be examining blood and urine hormone levels as~     well as measures of bone density including DXA and high-resolution peripheral quantitiative~     computed tomography. The investigators hypothesize that youth with type 1 diabetes will have~     slower bone accrual and impaired bone microarchitectural integrity compared with non-diabetic~     controls. The investigators hypothesize that poor bone accrual will be associated with~     sub-optimal glucose control as well as lower levels of insulin-like growth factor 1.~   "
109023|NCT02140411|"~     Ranibizumab is a humanized anti-vascular endothelial growth factor (VEGF) monoclonal antibody~     fragment approved in Chile by the Instituto de Salud Pública for the treatment of diabetic~     macular edema (DME), retinal vein occlusion and age-related macular degeneration.~      Currently, there is limited epidemiologic information in Chile regarding the incidence of DME~     and limited experience of anti-VEGF hospital therapy. This study will evaluate the efficacy~     of intravitreal ranibizumab in Chilean DME patients, to investigate the anatomical and~     functional improvement following this treatment and to increase the local experience~     regarding the use of anti-VEGF in the treatment of diabetic macular edema.~   "
109024|NCT02140398|"~     Laparoscopic Ovarian Drilling is a valid procedure for infertile anovulatory women with~     polycystic ovarian syndrome who failed to get pregnant or to ovulate with ovulation induction~     medications as clomiphene citrate or exogenous gonadotropins. The reasearchers supposed that~     endometrial curettage at time of laparoscopic ovarian drilling may boost fertility in these~     women.~   "
109025|NCT02140385|"~     The purpose of this study is to determine whether leaving a thicker layer -which preserves~     the tissue called Scarpa's fascia -intact during an abdominoplasty (tummy tuck) decreases the~     damage to the lymphatic system.~      In order to investigate the effect of leaving a thinner or slightly thicker layer intact~     during a tummy tuck, patients who are already planning to undergo the surgery, and who agree~     to participate, will be randomly assigned to two groups in a manner similar to flipping a~     coin. The first group will have their abdominoplasty performed with a thinner layer of~     abdominal wall left in place while the second group will have the surgery with a slightly~     thicker layer left in place. Both methods of doing a tummy tuck meet acceptable standards of~     care, and the aesthetic outcomes will not be negatively impacted by either of the options.~      Before and after the surgery, a procedure called lymphoscintigraphy will be performed.~     Lymphoscintigraphy is a special type of imaging where a dye, called a radiotracer, is~     injected and then detected by a special camera. The pictures provided by the~     lymphoscintigraphy allow investigators to look at the lymphatic system, which is a small~     network similar to blood vessels that helps drain extra fluid. The lymphoscintigraphy will~     help investigators to know what method of performing the tummy tuck leaves the lymphatic~     system most intact.~      In addition, photographs of each patient's abdomen will be taken using a special camera that~     allows investigators to put the photographs in the computer and compile a 3-dimensional~     image. Investigators will be able to look at the volume changes from swelling after the~     surgery using these pictures. Finally, an ultrasound will be used to help identify any~     seromas, or fluid collections, that may form after the surgery.~      The lymphoscintigraphy, photographs and the ultrasound combined will help determine whether~     or not leaving a thicker or thinner layer during a tummy tuck helps preserve the fluid~     draining lymphatic system and whether or not that effects recovery after the procedure.~   "
109026|NCT02140372|"~     This is a pilot study. Volunteers will be given 1.8 mg (1.2 mg followed by 0.6 mg one hour~     later), 1.2 mg, or 0.6 mg of colchicine. Blood will be collected prior to drug~     administration, 2 hours after colchicine administration, and 24 hours after colchicine~     administration via the antecubital vein and evaluated for markers of platelet activity and~     inflammation.~   "
109027|NCT02140359|"~     Housing First programs are promising approaches to transitioning substance using chronically~     homeless adults to affordable housing. However, Housing First programs need to provide~     support to residents to adjust to their changing social environments. The proposed project~     fulfills a critical gap by developing an electronic tool for a social network intervention~     using motivational interviewing techniques as well as results of a pilot test of the tool.~     The hypothesis to be tested is that Housing First residents who are given the intervention~     will be significantly more motivated to change their drinking, drug use, sexual risk~     behaviors, and social networks compared to controls receiving usual care.~   "
109028|NCT02140346|"~     RV1729 is a new medicine being developed for the potential treatment of asthma and smoking~     related lung disease (also known as chronic obstructive pulmonary disease - COPD). The~     objective of this study is to investigate the safety, tolerability, pharmacokinetics and~     pharmacodynamics repeat doses of RV1729 in patients with COPD for 28 days.~   "
109029|NCT02140333|"~     The purpose of this study is to determine whether 100mg erlotinib had similar effect compared~     with 150mg erlotinib in NSCLC patients with EGFR mutation in China.~   "
109030|NCT02140320|"~     RV1729 is a new medicine being developed for the potential treatment of asthma and smoking~     related lung disease (also known as chronic obstructive pulmonary disease - COPD).~      The objective of this study is to investigate the safety, tolerability and pharmacokinetics~     of single doses of RV1729 and repeat doses of RV1729 for up to 28 days.~   "
109031|NCT02140307|"~     The purpose of the study is to investigate health-promoting and stress-reducing~     psychological, physiological and hormonal effects of a 9-week meditation-based course in~     personal health and to examine potential baseline factors for any such effects. Thus, the~     investigators will investigate the course format (individual course or group-based course) as~     a potential factor the course outcome, and also individual background factors such as~     demographics and genetic variations.~   "
109037|NCT02140229|"~     Remission is nowadays an achievable objective for Rheumatoid Arthritis (RA) patients thanks~     to a large choice of therapies, early treatment and tight control (30% relapse).~      Ultrasound (US) driven-therapy, complemented with a clinico-biological follow-up, may improve~     the prognosis of RA in remission by increasing the duration of sustained remission and by~     preventing radiographic structural progression.~      The tested hypothesis is: The US coverage of RA allows to increase the duration of sustained~     clinical remission.~   "
109038|NCT02140216|"~     An increasing number of publications have demonstrated that homologous (allogeneic) blood~     transfusion impairs outcome in cancer and non-cancer patients. Leukocyte depletion of blood~     products cannot solve these problems, despite improved quality of red cells; a recent study~     demonstrated deteriorated outcome of cancer patients with elective colon surgery and~     transfusion of leukocyte depleted allogeneic blood.~   "
109039|NCT02140203|"~     Metabolic syndrome (MetS) is a clustering of cardiovascular risk factors characterizing~     central obesity, insulin resistance, dyslipidemia and high blood pressure. The concept of~     MetS represents the pre-cardiovascular and pre-diabetic pathologic conditions, which has been~     a useful tool in prognosing the development of cardiovascular disease and diabetes mellitus.~     Importantly, interventions applied at the pre-pathologic stage with MetS would be of great~     clinical and health significance in achieving better preventive and therapeutic outcomes.~     Yoga, a mind-body exercise, has been suggested to have beneficial effects on dyslipidemia,~     hypertension and diabetes. A pilot study has demonstrated the trends in the improvement of~     metabolic parameters in middle-aged adults with MetS but the findings are inconclusive~     because of the small sample size and brief yoga follow-up period (i.e., 2-month). In addition~     to the needs of a better designed randomized controlled trial in studying the beneficial~     effect of yoga in controlling MetS in middle-aged individuals, the investigation on yoga and~     MetS in elderly population has been lacking. This is important as the potential use of yoga~     as lifestyle modification in elderly individuals with MetS will result in significant~     reduction of the prevalence of cardiovascular disease and diabetes. Thus, this study aims to~     examine the efficacy of yoga exercise in improving metabolic abnormalities in middle-aged and~     older adults with MetS. In addition to elderly, middle-aged adults are included in the~     present investigation because of the idea that cardiovascular diseases and diabetes with~     aging can be mostly prevented by intervention at the middle-age. A randomized controlled~     trial with repeated measure design will be conducted to examine the effect of 1-year regular~     yoga training on the MetS parameters in middle-aged and older individuals who are 30-60 and~     60-80 years of age, respectively. Primary outcome measures include waist circumference,~     systolic/diastolic blood pressure, blood glucose, triglyceride, and lipid cholesterol profile~     whereas secondary outcome measures include self-reported stress and depression levels. This~     study is anticipated to provide valuable information in exploring the therapeutic role of~     yoga in managing MetS. As yoga exercise is an economical regimen which can be easily and~     readily applied to large scale of target population, it is of hope to be practically useful~     to relieve the burden on cardiovascular disease and diabetes by introducing yoga lifestyle to~     the management of MetS.~   "
109040|NCT02140177|"~     Background:~      - Suicide is the 10th leading cause of death for U.S. adults. Medically ill people are at an~     increased risk of suicide. Most people who have killed themselves went to a healthcare~     provider within 3 months of their death. More and more, hospitals are being asked to assess~     people for signs of suicide risk so that they can get the help they need. If nurses and~     doctors can find out who is at risk they can make sure these people get help in the hospital.~      The asQ em (Ask Suicide-Screening Questions to Everyone in Medical Settings) is a brief~     questionnaire. It was created to detect suicidal thoughts and behaviors in hospitalized~     people. Researchers would like to further develop this tool and figure out which are the best~     questions to ask patients.~      Objective:~      - To determine the best questions for healthcare providers to ask people with medical~     illnesses to see if they are having suicidal thoughts or planning to hurt themselves.~      Eligibility:~      - NIH Clinical Center patients over age 18.~      Design:~        -  Participants will be asked questions about how they have been feeling in the past few~          weeks. They will be asked questions about depression, anxiety, and suicidal thoughts and~          behaviors. They also will be asked some background questions.~        -  It will take approximately 15 to 30 minutes to answer the questions.~   "
109041|NCT02140164|"~     Background:~      - Some people with retinitis pigmentosa (RP) have macular edema (swelling) in the central~     retina. This can cause decreased central vision. The cause of macular edema is unknown, but~     may involve inflammation. The drug minocycline might help prevent inflammation and therefore~     might help treat macular edema and improve central visual function .~      Objectives:~      - To see if minocycline helps people with RP and macular edema.~      Eligibility:~      - People 12 years and older with RP who have macular edema in at least on eye.~      Design:~        -  Participants will be screened with medical and eye disease history. They will have an~          eye exam and blood tests. One eye with macular edema will be the study eye. If both eyes~          are affected, one will be designated the study eye.~        -  Participants will visit the clinic at least 9 times over at least 14 months. The first 3~          study visits will be monthly, then every 2 months.~        -  Participants will start taking minocycline after visit 3. They will take 1 pill twice~          daily for at least 1 year.~        -  Participants will keep a medicine diary and bring it to each visit with their pill~          bottle and unused pills.~      At each study visit, participants will have some or all of the following tests:~        -  eye and thyroid exams~        -  blood and pregnancy tests~        -  microperimetry: participants will press a button when they see a light on a computer~          screen~        -  visual field measurement: participants will look at spots on a white screen to test side~          vision~        -  electroretinogram: A person will be dark adapted by sitting in the dark for 30 minutes.~          After the placement of numbing eye drops, special contact lenses will be placed . The~          participant will watch flashing lights and recordings will be made.~   "
109042|NCT02140151|"~     This study will determine whether quarterly injections of Ranibizumab may prevent eyes with~     dry age-related macular degeneration from progressing to wet age-related macular degeneration~     (AMD).~   "
109043|NCT02140138|"~     The purpose of this study is to evaluate the induction of immune responses against CV9104~     administered by conventional intradermal injection or with a needle-free intradermal~     injection device and to assess the safety and tolerability of CV9104 administered by~     conventional intradermal injection versus injection with a needle-free intradermal injection~     device versus no injection.~   "
109044|NCT02140125|"~     The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of~     single subcutaneous dose of ASP2408 in non-elderly healthy adult male subjects. The~     pharmacodynamics of ASP2408 is also being evaluated.~   "
109045|NCT02140112|"~     This is a randomized, double-blind, 2-arm, placebo-controlled crossover study in pediatric~     patients with autism spectrum disorder with all patients receiving 16-weeks of TSO treatment~     and 16 weeks of placebo.~   "
109058|NCT02139943|"~     The purpose of this study is to assess the effects of administration of canagliflozin 100 mg~     and 300 mg, compared with placebo as an addition to insulin therapy for the treatment of Type~     1 Diabetes Mellitus (T1DM).~   "
137624|NCT01765855|"~     This is a open label, single center, single oral dose, study of PRT054021, in healthy~     subjects.~   "
109046|NCT02140099|"~     Adolescent risk behaviours, such as violence and substance use, are prevalent public health~     concerns in Canada. Further, these behaviours often co-occur, and are associated with poor~     mental health. However, the majority of prevention programs focus on preventing single issues~     and do not consider mental health, and also neglect the importance of relationships when~     promoting positive youth development. To address this gap, the Centre for Addiction and~     Mental Health (CAMH) Centre for Prevention Science designed the Fourth R Healthy~     Relationships Plus Program, a small group program focused on the promotion of positive mental~     health and the reduction of violence and substance use, via the development of improved~     communication, interpersonal and help-seeking skills. The purpose of this study is to~     evaluate the Fourth R Healthy Relationships Plus program using both outcome (randomized~     controlled trial design with follow-up at pre-test, post-test, and 4, 8 and 12 months) and~     process evaluation tools.~      The primary study hypothesis is that participation in the Fourth R Healthy Relationships Plus~     program will be associated with positive growth in treatment participants' psychological~     well-being from pre-test to 12-month follow-up, as compared to control participants. In~     secondary analyses, the study will explore if treatment participants report less substance~     use, peer violence, bullying and dating violence at 12-month follow-up than control~     participants. Since certain person-level (e.g., sex, personality, executive functioning) and~     program-level (e.g., implementation quality) variables may moderate treatment-outcome~     relationships, these associations will also be explored. The final hypothesis is that~     treatment participants will report better attitudes, knowledge and assertive communication at~     post-test compared to control participants, and that these improvements will mediate the~     association between program participation and 12-month outcomes.~   "
109047|NCT02140086|"~     A randomized, controlled trial to investigate the effects of a buteyko based remedial~     breathing therapy on children with asthma regarding to their symptoms, use of medication and~     lung function tests.~   "
109048|NCT02140073|"~     The purpose of this study is to determine the efficacy, safety, and tolerability of~     omeprazole in combination with domperidone in GERD treatment for subsequent efficient~     pharmacotherapy of GERD.~      Objectives of the trial To assess the efficacy of omeprazole in combination with domperidone~     regarding change of incidence and severity of clinical symptoms of GERD during 8 weeks of~     treatment To compare the efficacy of omeprazole in combination with domperidone regarding~     change of incidence and severity of clinical symptoms of GERD during 8 weeks of treatment To~     assess the efficacy of omeprazole in combination with domperidone regarding change of~     incidence and severity of endoscopic symptoms of GERD during 8 weeks of treatment To compare~     the efficacy of omeprazole in combination with domperidone regarding change of incidence and~     severity of endoscopic symptoms of GERD during 8 weeks of treatment To determine the~     efficiency and advantages of one GERD therapy considering efficacy, safety, and individual~     variance of patients' reactions~   "
109049|NCT02140060|"~     The purpose of this study is to evaluate Travoprost/Brinzolamide fixed combination~     (Trav/Brinz) administered twice daily as compared to each of its marketed components~     (TRAVATAN Z® solution and AZOPT® suspension) and to the unfixed combination of TRAVATAN Z®~     plus AZOPT® in lowering intraocular pressure (IOP).~   "
109050|NCT02140047|"~     The purpose of this study is to evaluate efficacy and safety of MT-2301 when co-administered~     with DPT-IPV using ActHIB® as a control in healthy infants.~   "
109051|NCT02140034|"~     This study is carried out to determine the merit and reliability of extensive intraoperative~     peritoneal lavage as a preventive strategy~      Hypothesis: EPL significantly improve the overall survival of patients by reducing the risk~     of peritoneal recurrence~   "
109052|NCT02140021|"~     The goal of this clinical research study is to learn how often high-grade dysplasia or~     invasive squamous cell carcinoma of the anus occurs in women with high-grade dysplasia~     invasive squamous cell carcinoma, invasive adenocarcinoma, or AIS of the cervix, vagina, or~     vulva.~   "
109053|NCT02140008|"~     Supraglottic airway devices (SADs) are well established in pediatric anesthetic practice. The~     pediatric i-gel and the self-pressurised air-Q (air-Q) are new supraglottic airway devices~     for children. The i-gel is made of a soft, gel-like elastomer with a noninflatable cuff. The~     air-Q is a new single-use device that may optimise the airway seal while reducing the~     potential for postoperative complications such as sore throat. The overall structure of the~     air-Q SP is identical to the original air-Q, except with regard to the inflatable cuff. The~     aim of this randomized trial was to compare the clinical performance of the i-gel and the~     air-Q SP.~   "
109054|NCT02139995|"~     Guidelines for blood transfusion have been issued for years. According to these guidelines,~     red blood cells (RBCs) transfusion should be given when the hemoglobin level is less than~     6g/dL or 7g/dL and is unnecessary when the level is more than 10g/dL. However, in all the~     guidelines, the determination of whether RBCs should be administered when the hemoglobin~     level is in the range of 6~10g/dL is based on the judgment from doctors. Index of transfusion~     trigger for patients with hemoglobin level between 6g/dL and 10g/dL is necessary and~     important in clinical practice.~      Based on the aim of blood transfusion that maintain the balance of oxygen supply and oxygen~     consumption, the investigators hypothesize that index of transfusion trigger for patients~     with hemoglobin level between 6g/dL and 10g/dL could be calculated by parameters including~     infusion rate of inotropic drugs for maintaining normal cardiac output, fraction of inspired~     oxygen, core temperature, and torlerance to anemia. To verify this hypothesis, the~     investigators present West China Transfusion Score for Critically-ill Patients(WCTS-CP) for~     the trigger of transfusion according to the patient's history and monitoring parameters, and~     the investigators design a randomized controlled clinical trial to test this score.~   "
109055|NCT02139982|"~     Phase 1 Sympathetic block leads to vasodilatation and increases in blood flow. However,~     regional hemodynamic changes of radial and ulnar artery after specific nerve block of~     brachial plexus remains unclear. The aim of the study is to assess the effect of specific~     nerve block of brachial plexus on hemodynamics of upper extremity, and provides evidence for~     further research in patient undergoing microvascular surgery.~      Phase 2 There is no literature about dose-finding studies of sympathetic block after brachial~     plexus block. Little is known regarding the relationship between concentration of local~     anaesthetic and vasodilation of upper extremity. The aim of this randomized, double-blind,~     prospective dose-response study is to determine the ED50 and ED95 of ropivacaine in~     sympathetic block of upper extremity after supraclavicular block~   "
109056|NCT02139969|"~     The purpose of this study is to gain information on the safety, efficacy, and quality of life~     in subjects who have had the GreenLight XPS procedure.~   "
109057|NCT02139956|"~     Continent women have an intact internal urethral sphincter that extends from the bladder neck~     down to the perineal membrane. The internal urethral sphincter is a strong collagen muscle~     tissue cylinder lined by urothelium. On ultrasound scanning tissue echo will be detected torn~     internal urethral sphincter will not stand sudden rise of abdominal pressure. Three~     dimensional ultrasound assessment of the internal urethral sphincter is very sensitive and~     specific for the diagnosis of stress urinary incontinence.~   "
109060|NCT02139917|"~     Primary aim:~        1. To compare the effects of customary care and an interventional Home-based Palliative~          Renal Program (HBPRP) for ESRF patients~        2. To compare the effects of customary care and Home-based Palliative Program (HBPP) for~          ESRF patients~           Secondary aim:~        3. To explore the lived experiences of patients with ESRF. Hypothesis The transitional~          renal palliative care model is associated with decreased in unscheduled hospital~          readmission, reduce length of stay as well as improved quality of life for patients with~          end-stage renal failure.~   "
109061|NCT02139904|"~     This study is for patients with malignant mesothelioma of the lung lining (called pleura) who~     have had previous chemotherapy with a platinum-based regimen whose disease has progressed.~     Malignant pleural mesothelioma (MPM) is an aggressive, frequently drug resistant, and~     incurable disease that is increasing in incidence in the UK and worldwide. All patients with~     MPM will relapse following first line chemotherapy and at present, there is no standard~     treatment available for patients in the second line setting. The vinca alkaloid chemotherapy~     drug vinorelbine has shown promising activity in a single arm UK trial. However to date,~     there has been no randomised evaluation of vinorelbine in mesothelioma in the second line~     setting. In addition, there have been no trials which have looked at underlying molecular~     changes in mesothelioma which may predict vinorelbine efficacy; This might allow vinorelbine~     to be used in patients only where there is a chance of benefit. Studies suggest that~     vinorelbine requires a gene called BRCA1 (shown to be absent in 38% of mesothelioma cases) in~     order to induce cell death in mesothelioma. The VIM trial aims to establish whether~     vinorelbine in patients with MPM helps them live longer and whether the BRCA1 gene is helpful~     in selecting patients most likely to benefit from treatment.~      Patients will be randomised (1:2) to receive either active symptom control (ASC) (which is~     all supportive care deemed necessary for pain management excluding disease modifying~     treatment) or ASC with vinorelbine. Patients will continue vinorelbine treatment until~     evidence of disease progression (or unacceptable toxicity to the drug or patient withdrawal).~     If vinorelbine activity is demonstrated, we will use the results from this trial to inform~     the design of a future phase III trial.~   "
109062|NCT02139891|"~     This study will examine the additional clinical benefit conferred by multipoint pacing (MPP)~     compared to standard CRT over a period of 3 months. Patients will be randomized to MPP ON vs.~     OFF and followed for a total of 6 months. This includes two crossover periods for each pacing~     modality (MPP on vs. off).~   "
109063|NCT02139878|"~     Researchers at the University of Prince Edward Island want to learn about the health effects~     of wild blueberry juice.~   "
109064|NCT02139865|"~     When practicing weightlifting regularly the body makes new proteins within the muscle.~      These new proteins can increase the size of the cells within the muscle to make them larger,~     a process called hypertrophy. The common convention surrounding gains in skeletal muscle size~     and strength is that heavy weights are needed. In contrast, lifting lighter weights are~     thought to be required to induce muscular endurance and not to promote growth. However, it~     has previously been shown in untrained men that lifting lighter weights results in similar~     gains in muscle mass and strength as lifting heavier weights. The purpose of this study is to~     examine how performing resistance training of different intensities (light or heavy weights)~     affects the degree of muscle growth and strength gain in individuals who are already~     resistance training.~      This information will be valuable when designing exercise protocols for increasing muscle~     size and strength at all ages, or in individuals returning from injury, as a way to stimulate~     muscle growth and promote strength gains without the need to lift heavy weights.~   "
109065|NCT02139852|"~     Capsaicinoids (the active ingredient in hot peppers) have been shown to cause a moderate~     increase in energy expenditure (50 kcal/day) as well as reductions in appetite, energy~     intake, and (visceral) adiposity. As such, there is considerable interest in capsaicinoid for~     weight loss supplements. Of particular interest are the recent findings that free-fatty acids~     in the blood are elevated 2-2.5hrs post ingestion, yet changes in typical cardiovascular or~     sympathetic nervous tone indicators (heart rate, blood pressure) were unaffected, suggesting~     some of the negative consequences of other stimulants may be avoided. At present, however,~     more in depth investigations of the effects on endothelial function, vascular autonomic tone~     and inflammation are lacking.~      The investigators seek to understand the effect of 3 months capsaicinoid ingestion on~     alterations in body composition, traditional cardiovascular risk factors and cardiovascular~     function~      Hypotheses:~      1) Continued use of capsaicinoids will alter resting metabolism substrate use, which will~     result in moderate (but clinically meaningful) alterations in body composition manifested as~     a decrease in adiposity. 2) Blood lipids will be unaffected by capsaicinoid use, as will~     brachial blood pressure. 3) Levels of systemic inflammation may increase slightly, and this~     could have an effect on vascular reactivity to hyperemic flow or baseline vascular tone.~     However, previous research suggests that these alterations will not be manifested in~     autonomic nervous tone assessed by changes in heart rate variability.~   "
109066|NCT02139839|"~     The purpose of this study was to determine whether L. rhamnosus GR-1 and L. reuteri RC-14~     delivered via capsules to the vagina of post-menopausal women over a three day course of~     treatment can restore and maintain a lactobacilli-dominated microbiota. Exploratory analysis~     of microbial ecology, human microarrays and multiplex immunological assessments are included~     to characterize potential effects.~   "
109067|NCT02139826|"~     The purpose of this study is to compare the absorption and blood levels of IX-01 when given~     as a capsule compared to liquid form, and how food affects the absorption in healthy men.~   "
109089|NCT02139540|"~     Major depressive disorder (MDD) is a global medical problem with significant shortcomings in~     current therapy. Chief among these is the delay between initiation of pharmacologic therapy~     and clinical improvement in symptoms. Recently ketamine, an NDMA-receptor antagonist has been~     shown to rapidly and effectively reverse the symptoms of MDD. Nitrous oxide, another~     NMDA-receptor antagonist, may produce the same effect with a cleaner side-effect profile and~     perhaps without the need for intravenous access and anesthesia personnel. Therefore, we~     propose conducting a pilot randomized placebo controlled double-blind crossover study in~     which patients will receive up to 50% nitrous oxide in oxygen or up to 50% oxygen in air for~     a period of one hour in addition to standard medical therapy. Depression severity will be~     assessed by a blinded observer pre-treatment, 30 minutes and 2 hours post treatment using the~     Hamilton depression rating scale.~   "
109068|NCT02139813|"~     Several prospective trials and metaanalysis have demonstrated the superiority of bariatric~     surgery on the medical treatment of obesity. The Roux-en-Y Gastric ByPass (RYGBP) procedure~     has been practiced for more than 30 years, and is the procedure of choice for morbidly obese~     with metabolic disorders in most of the reference centers. Nevertheless, the RYGBP is a~     technically demanding procedure with a learning curve of more than 75 cases. The complication~     rate is around 10% in expert centers.~      More recently another procedure has been described which seems as efficient on weight loss~     and co-morbidities as the RYGBP, with the advantage of being less technically difficult and~     less morbid, especially for multi-complicated obese and/or the super obese. It consists of a~     unique gastro-jejunal anastomosis between a long gastric pouch and a jejunal Omega loop.~     However, this procedure could be at risk of biliary reflux and anastomotic ulcers with~     dysplastic changes of the gastric and esophageal mucosa. As a result, the Omega loop bypass~     (OLB) has only been developed by a few teams and remains a controversial subject,~     particularly as only one monocentric randomized trial has compared it to the RYGBP, which is~     remains the gold standard. The first litterature results show similar or even better weight~     loss efficiency than RYGBP with a better feasibility. The early complication rate seems~     lower, but there are still insufficient data on long term morbidity and biliary reflux~     consequences.~      By performing a randomized and prospective comparison of OLB to RYGBP, the aim of the~     investigators study is to analyze the weight loss efficiency, the morbidity and mortality,~     the feasibility, and the quality of life of both techniques, in order to validate the Omega~     loop bypass as a procedure of choice in bariatric surgery~      Hypothesis :~      The OLB, while being as efficient as RYGBP on weight loss and metabolic complications, could~     be less morbid.~   "
109069|NCT02139800|"~     This study is a 2-arm randomized, controlled, multi-center clinical trial to determine which~     of two strategies at birth are best to optimally aerate the lung of preterm infants.~     Specifically we will determine in 600 infants of 23-26 weeks gestational age (GA) requiring~     respiratory support at birth which of two lung opening strategies - either a standard~     PEEP/CPAP of 5-7 cm H2O in the delivery room (DR), as compared to early lung recruitment~     using Sustained Inflation (SI) in the DR, will result in a lower rate of the combined~     endpoint of death or bronchopulmonary dysplasia (BPD) at 36 weeks gestational age.~      Hypotheses:~        1. Early lung recruitment with SI superimposed upon standard PEEP/CPAP in the DR will~          reduce the need for mechanical ventilation in the first seven days of life, and reduce~          need for surfactant use; and~        2. A policy of DR SI on standard PEEP/CPAP recruitment will confer better outcomes at 36~          weeks post-menstrual age (PMA) than standard PEEP/CPAP~   "
109070|NCT02139787|"~     The purpose of this study is to use a community based participatory action research (CBPAR)~     approach to 1) create radio stories about Somali, Latino and Hmong families' real success~     stories with hypertension and obesity in managing their disease through implementation of~     healthful lifestyle behaviors (nutrition and physical activity), and 2) test the~     effectiveness and acceptability of radio stories on participant intentions to engage in or~     improve healthful lifestyle behaviors to prevent these disease. Participants in the~     Intervention condition listened to the radio stories and the participants in the control~     condition listened to an audio brochure with relevant health information. We hypothesized~     that the intervention participants would report higher intentions to engage in various~     healthful lifestyle behaviors than the control participants after both participants listened~     to their respective health information.~   "
109071|NCT02139774|"~     This study is testing a walking program called Walk with Ease by the Arthritis Foundation~     with men undergoing treatment for prostate cancer. The researchers are interested in how easy~     or difficult it is for these men to participate in this program and whether or not is is~     helpful to them during their care.~   "
109072|NCT02139761|"~     Cocaine continues to be one of the most widely used substances of abuse around the world. In~     the US, an estimated 1.4 million individuals (0.5%) > 12 years were current (past month)~     cocaine users in 2011. Currently, no FDA-approved pharmacologic treatments are available for~     cocaine addiction; thus, this remains a serious public health problem without an effective~     pharmacological treatment. A promising lead towards an effective treatment comes from a~     recent finding that pretreatment with oral l-tetrahydropalmitine (l-THP) in rats attenuated~     the cocaine seeking associated with a cocaine challenge, while having no motor effects. This~     finding stimulated our group to test the pharmacokinetics and safety of l-THP in a phase I~     study of people with cocaine use. Preliminary findings show l-THP is safe and well tolerated~     in cocaine users, with no adverse interactions with cocaine.~      This study will test the efficacy and safety of l-THP for abstinence in those with cocaine~     addiction in a phase II pilot study (N=24). Secondarily, we will examine the effects of these~     medications on craving.~   "
109073|NCT02139748|"~     Dental implant placement and simultaneous grafting using one layer gum graft will result in~     the same facial ridge contour and soft tissue thickness as one layer of gum graft plus bone~     graft.~   "
109074|NCT02139735|"~     The combination of ultrasound and muscular stretching may have positive effects on pain~     relief and on the balance of the masticatory muscles activity.~   "
109075|NCT02139722|"~     Liver cancer and hepatitis B are major health disparities for Asian Americans, while~     hepatitis C is a rising problem. Little is known about how to improve the quality of health~     care Asian Americans receive in general and for viral hepatitis in particular. Technology,~     specifically mobile applications, potentially can provide a flexible and efficient way to~     address these challenges. This proposed project seeks to develop, implement, and test an~     intervention to increase hepatitis B and C screening for Asian Americans in 2 healthcare~     systems in the San Francisco Bay Area.~      The research team will develop, implement, and evaluate the efficacy of an interactive,~     patient- centered mobile application for use on a tablet computer to increase the rate of~     hepatitis B and C screening among unscreened Asian Americans age 18 and older. The team will~     use their experience from a successful track record in health promotion to develop the~     intervention by working with patients, community leaders and advocates, clinical staff,~     healthcare providers, and healthcare system administrators from a county safety net system~     and an academic primary care practice in the San Francisco Bay Area. The mobile application~     will include video clips with a physician (Video Doctor) addressing patient concerns~     regarding hepatitis B and C screening in the patient's preferred language, English, Chinese,~     or Vietnamese. A patient who has not been screened for hepatitis B will answer questions~     about his or her characteristics and preferences using the mobile application. The mobile~     application will then show 30-60 seconds video clips with messages that address the patient's~     responses related to hepatitis B screening and that are delivered by an actor playing a~     physician. Those who are born between 1945 and 1965 also receive messages about hepatitis C~     screening. At the end, the tablet computer will generate a provider alert to let the treating~     provider know what the patient's preferences are regarding testing for viral hepatitis.~      Once developed, the intervention will then be used in combination with a physician panel~     notification and tested against physician panel notification only in a randomized controlled~     trial to see which approach is better in increasing the rate of hepatitis B and C screening.~     The team will also work with the 2 healthcare system to ensure that the interventions will be~     practical and easily adopted once the study is over. The findings of this project will~     greatly expand understanding about how to use technology- based interventions to improve~     quality of healthcare in diverse patient populations.~   "
109090|NCT02139527|"~     The purpose of the registry is to assess outcomes following treatment with lumbar total disc~     replacement (TDR) in patients outside the clinical trial setting.~   "
109103|NCT02139358|"~     The purpose of this study is to evaluate the safety and activity of gemcitabine plus~     trastuzumab and pertuzumab in patients with metastatic human epidermal growth factor receptor~     2 (HER2)+ breast cancer who have progressed on at least one prior line of chemotherapy plus~     HER2 targeted agent such as T-DM1, trastuzumab, or lapatinib.~   "
109076|NCT02139709|"~     The overall objective of this study is to demonstrate how dietary ganglioside may protect the~     gut attenuate inflammatory signals in the intestinal mucosa.~      Gangliosides are dietary fats found in milk and are important constituents of intestinal~     cells. Our previous studies have shown that inflamed intestinal mucosal cells have reduced~     ganglioside content compared to normal mucosal cells. Gangliosides are glycolipids found on~     the surface of the intestinal mucosa and in lipid rafts in enterocytes and lymphocytes.~     Gangliosides influence microbial attachment, cell division, differentiation, signaling and~     mucosal integrity. Preclinical studies show that provision of ganglioside in cell culture and~     in animal diets increase ganglioside content in mucosal cells and down regulates signals~     caused by pro-inflammatory stimuli. In subjects with active Crohn's disease, consumption of~     ganglioside remarkably improved the Crohn's Disease Activity Index. In healthy control~     subjects, dietary ganglioside improved intestinal permeability and decreased production of~     pro-inflammatory prostaglandin E2.~      It is proposed that ganglioside degradation is elevated in the inflamed gut of IBD patients.~     Provision of ganglioside in the diet replaces ganglioside in the gut, consequently restoring~     proper structure and function to the diseased intestine and inducing disease remission.~     Insight into diet-based treatment would allow IBD patients to live healthy and happy lives.~     The main research objective is to characterize how ganglioside catabolism is associated with~     increased signaling from pro-inflammatory mediators and how reduction in ganglioside levels~     can be ameliorated by ganglioside supplementation during active inflammatory disease. This~     study will assess molecular mechanisms by which ganglioside alters gut permeability,~     inflammatory mediators and cell signaling.~   "
109077|NCT02139696|"~     To evaluate the usability of positron emission tomography imaging as a novel outcome measure~     in multiple sclerosis studies~   "
109078|NCT02139683|"~     The purpose of this study is to assess the treatment of fibroadenomata with a circumferential~     sonification treatment with HIFU..~   "
109079|NCT02139670|"~     In total 120 pregnant women's with history of recurrent miscarriages, are planned for~     inclusion in this trial. After signing an informed consent a blood sample will be obtained~     from each participant. The investigators will measure the thrombin generation in plasma~     assessed by the calibrated automated thrombogram (CAT). The relation between pregnancy~     outcome and thrombin measurements will be determined~   "
109080|NCT02139657|"~     This is a single-arm, open-label study of Rabies Immune Globulin (Human),~     Caprylate/Chromatography Purified (RIG-C), in approximately 12 healthy subjects. The purpose~     of this study is to characterize the rabies virus-specific antibody titer after a single~     intramuscular injection of 20 IU/kg RIG-C and to evaluate the safety and tolerability of~     RIG-C.~   "
109081|NCT02139644|"~     The primary objective of this study was to evaluate the efficacy of fluticasone propionate~     multidose dry powder inhaler (Fp MDPI) and fluticasone propionate/salmeterol xinafoate~     multidose dry powder inhaler (FS MDPI) when administered over 12 weeks in patients 12 years~     of age and older with persistent asthma.~      Study drug and placebo was supplied in Teva multidose dry powder inhaler (MDPI) devices and~     provided for participants to use at home. Participants performed spirometry at every visit.~     Each participant was given a diary at each visit for use until the next visit. Rescue~     medication (albuterol/salbutamol) was dispensed at each visit, if needed, as determined by~     the investigational center personnel.~   "
109082|NCT02139631|"~     The noninvasive ventilation (NIV) is a method of ventilatory support that does not require~     artificial airway. Its application is associated with complex hemodynamic repercussions,~     therefore is important to identify them for safety and effectiveness of the technique~     application.~      The main objective of this research is to evaluate the hemodynamic repercussions using~     doppler echocardiography in healthy volunteers submitted a different values of positive end~     expiratory pressure (PEEP) by the following ventilatory modes: Continuous positive airway~     pressure (CPAP) and Bilevel.~      The study hypothesis is that the positive end expiratory pressure (PEEP) may cause~     hemodynamic repercussions as: reduction of the ventricles pre-load, left ventricle after~     load, cardiac output and reduction in the diameter of the superior vena cava, due to the~     increase in the intrathoracic pressure and pulmonary volumes.~   "
109083|NCT02139618|"~     Treatment of actinic damage has included multiple procedures but to date there is limited~     scientific evidence to support the preferential use of one of these therapies according to~     their efficacy, safety and pain tolerance by patients. This study aims to assess the efficacy~     of methyl aminolevulinate + daylight vs placebo + daylight to treat facial photodamage~   "
109084|NCT02139605|"~     Stomach cancer is the second most common cause of cancer-related deaths in India. Curative~     surgery offers the only chance of improving survival in this cancer. In patients whose cancer~     has not spread to other parts of the body (beyond the stomach and lymph nodes around it),~     removal of stomach (gastrectomy) with lymph nodes around the stomach and along the major~     vessels supplying blood to the stomach (D2 lymphadenectomy) is regarded as current standard~     of care at Tata Memorial Centre. However, the extent of lymphadenectomy is controversial.~     Some studies have suggested that removing more lymph nodes, even around the major vessels of~     the abdomen (aorta and inferior vena cava) may not only help to accurately determine the~     disease spread, but may also confer an additional survival benefit. Removing more lymph nodes~     around the major vessels may increase the risk of morbidity to the patient.~      In the last 5-6 years, stomach cancer specialists around the world have resorted to giving~     half the cycles of chemotherapy to the patient before the surgery (neoadjuvant chemotherapy),~     and the other half after the surgery in what is called 'perioperative chemotherapy'. This has~     been shown to lead to more patients surviving to 5 years, than before.~      The investigators feel that perioperative chemotherapy with D2 lymphadenectomy may constitute~     the best care for our patients with stomach cancer such that no further removal of lymph~     nodes beyond is required. However, the investigators have no evidence in literature to~     support this hypothesis. The investigators have thus designed this trial based on which we~     propose that there exists no difference between a D2 lymphadenectomy and a D3 lymphadenectomy~     following neoadjuvant chemotherapy for non-metastatic, locally advanced but resectable~     gastric cancer. The data will enable the development of clear management guidelines for lymph~     node dissection in stomach cancer.~   "
109085|NCT02139592|"~     The purpose of this study is to evaluate the safety of brentuximab vedotin (recombinant) for~     IV infusion (ADCETRIS IV Infusion 50 mg) in patients with relapsed/refractory CD30+ Hodgkin's~     lymphoma or anaplastic large cell lymphoma in the routine clinical setting, as well as to~     collect efficacy information for reference.~   "
109086|NCT02139579|"~     Epidermal growth factor receptor (EGFR) tyrosine kinase is one of most popular target~     molecules in the field of anticancer drug research. EGFR is highly expressed in many types of~     tumor cells, which could activate EGFR cytosolic kinase activity by binding to its ligand~     EGF, and regulates gene expression, cell proliferation, differentiation, apoptosis through~     different signal transduction pathways. Epidermal growth factor receptor tyrosine kinase~     inhibitor (EGFR-TKI), competitive to specifically combined with the EGFR kinase domain, thus~     inhibits its kinase activity, thereby blocking cancer cell proliferation or metastasis. At~     present, EGFR-TKI has been widely used in clinical activity, especially in patients with EGFR~     mutations, which had been proved to achieved a certain effect. But with the passage of time,~     a drug resistance is inevitable.~      At present, studies have found that the cessation of treatment immediately after EGFR-TKI~     resistance may lead to rapid progress of cancer. Chemotherapy, as one of the most widely~     accepted modality in cancer treatment, might also be one of the salvage therapies of target~     treatment. Therefore, in patients with better physical status (PS) scores, chemotherapy is~     commonly applicable.~      In January 2010, a study published in the journal of Clinical Lung Cancer reported the~     application of chemotherapy as salvage treatment for advanced non-small cell lung cancer~     (NSCLC) patients with resistant to first-line EGFR-TKI treatment. Of the 114 patients~     enrolled, 67 received sequential chemotherapy, the other 47 patients received best supportive~     care. The results showed that, sequential chemotherapy can improve the survival time of the~     patients, compared with chemotherapy and supportive care groups (11.2 months vs. 3.8 months,~     P< 0.01). Furthermore, in those who received sequential chemotherapy, a regimen containing~     paclitaxel got higher efficiency and disease control rate than those without (48.7% vs.~     21.4%, 79.5% vs. 53.5% , P< 0.05), as well as longer progression-free survival (PFS, 5.1~     months vs. 1.8 months, P< 0.01) and overall survival (OS, 12.7 months vs. 7 months, P< 0.01).~      Another study in Taiwan which enrolled 195 patients treated with at least 1 cycles sequential~     chemotherapy after first-line gefitinib shown similar results. Generally, gefitinib as a~     first-line treatment had PFS for 5 months, and the second-line treatment efficiency was~     14.4%. Regimens of platinum or paclitaxel had a better treatment efficiency (50.6%). A poor~     therapeutic effect was reported for gefitinib as second-line therapy (5.6%). In total, the~     median OS of second-line treatment was 12.2 months. In addition, platinum containing regimens~     survival better (21.7 months vs. 8.9 months, P< 0.01); patients with mutant EGFR benefit more~     in a platinum-based chemotherapy (24.5 months vs. 8.5 months, P< 0.05).~      Bevacizumab (trade name Avastin ®) is a kind of recombinant humanized monoclonal~     immunoglobulin gamma-1 (IgG1) antibody, which can selectively inhibit the combination process~     of vascular endothelial growth factor (VEGF) and its receptor, Flt-1 and kinase domain~     receptor (KDR) in endothelial cells. A reduction of tumor angiogenesis, blood supply, oxygen~     and other nutrients supply could be obtained after the VEGF loss of its biological activity,~     thus inhibit tumor growth. The drug was approved for the first-line treatment of advanced~     colorectal cancer in 2004 by America food and Drug Administration (FDA),thus became the first~     for clinical use of drugs that targeting VEGF. As the first globally approved anti-angiogenic~     monoclonal antibody drugs, bevacizumab has approved for advanced colorectal cancer, lung~     cancer, breast cancer, renal cell carcinoma and malignant glioma patients, which was used in~     more than 500000 cases. In the field of advanced NSCLC treatment, clinical results confirm~     bevacizumab combined with chemotherapy can prolong OS and PFS of patients with NSCLC, and~     well tolerated.~      The thirty-fifth annual meeting of the European Society of Medical Oncology (ESMO) conference~     released a meta analysis results of bevacizumab combined with platinum chemotherapy for~     first-line treatment of advanced non squamous NSCLC. It is confirmed that, treatment with~     bevacizumab based chemotherapy for advanced non squamous NSCLC patients could achieve~     significant survival benefit, prolong remission time, and expected safety.~      Therefore, the investigators design this phase II to testify the efficacy and safety of~     bevacizumab + chemotherapy for EGFR-TKI resistant non squamous NSCLC.~   "
109087|NCT02139566|"~     A two-part study to test the efficacy of alternative consent procedures and the efficacy of~     alternative methods to improve survey completion.~   "
109088|NCT02139553|"~     The purpose of this study is to determine whether rhythmic upper-limb movement training in~     post-stroke patients allows to improve only this particular type of movements or if it also~     improves some parameters of discrete movements. Based on our results we hope to be able to~     answer a fundamental question: are rhythmic and discrete movements two independent~     primitives?~   "
109102|NCT02139371|"~     The primary objective of the study is to test a new radiotracer called 64Cu-DOTA-AE105 for~     PET imaging of uPAR (urokinase plasminogen activator receptor). The tracer has the potential~     of identifying the invasive cancer phenotype, thereby distinguishing between aggressive and~     less aggressive tumors. This is a first in human study to test the radiotracer in cancer~     patients. The biodistribution and tumor uptake will be evaluated by repeated PET imaging (1,3~     and 24 hours post injection).~   "
137625|NCT01765842|"~     Comparison of the Efficacy of Two Rituximab Treatment Regimens in Patients With Lupus~     Nephropathy Resistant to Conventional Treatments~   "
109091|NCT02139514|"~     The purpose of this study is to predict and explain on the basis of brain function and~     structure the behavioral and brain effects of an evidence-based intervention for adults with~     high-functioning autism, Virtual Reality-Social Cognition Training (Kandalaft et al., 2012;~     Journal of Autism and Developmental Disorders). Adults with autism will be randomly assigned~     to receive either (a) two hours per week of intervention services for five weeks, or (b) a~     treatment as usual control. The intervention will focus on enhancing social skills, social~     cognition, and social functioning. Outcome measures will evaluate changes in these social~     skills, cognition, and functioning using standardized assessments. We will perform structural~     and functional magnetic resonance imaging (MRI) scans at three time points-before, during,~     and after treatment (i.e., Time Point #1, 2, and 3).~   "
109092|NCT02139501|"~     The project was undertaking by Qilu Hospital of Shandong University and other well-known~     hospitals in China. In order to study the efficacy and safety of different dose and frequency~     Recombinant Human thrombopoietin in treating the primary immune thrombocytopenia (ITP)~   "
109093|NCT02139488|"~     To quantify motion based variation of the target volume of the primary tumor over the course~     of chemoradiotherapy in esophageal cancer patients, and to use this information to calculate~     appropriate PTV (planning target volume) margins according to the margins recipe for patients~     receiving trimodality (neoadjuvant chemoradiation and surgery) or definitive chemoradiation~     in order to personalize radiation treatment, resulting in either better target coverage or a~     reduction in normal tissue radiation exposure.~   "
109094|NCT02139475|"~     The aim of this study is to clarify the factors influencing quality of bowel cleansing for~     colonoscopy in patients with colorectal cancer surgery and confirm the adequate bowel~     cleaning method for patients with colorectal cancer surgery. Through this, ultimately in~     patients with a history of colorectal cancer who have high risk of colorectal cancer, it~     could be possible to detect cancerous lesions early and increase the survival rate.~      This study is based on observational study Subjects are the patients with colorectal cancer~     surgery who visits the out patients clinic for follow-up colonoscopy The patient's medical~     records on the basis of information collected at the point of the colonoscopy performed~     Quality of bowel cleansing is calculated with the Boston bowel preparation scale Patient~     compliance and satisfaction are measured.~   "
109095|NCT02139462|"~     This study will use a data base of archived therapy sessions of family therapy for adolescent~     anorexia nervosa to determine the role of fidelity to treatment and outcome. In addition, it~     will develop a novel, more efficient way to train therapists in family therapy for adolescent~     anorexia nervosa and examine if it is feasible to conduct a trial comparing this novel~     training to standard, more intensive training.~   "
109096|NCT02139449|"~     CRT and ICD has known as decreasing cardiac mortality in patient with heart failure.~     Especially, it has reported that CRT improved cardiac systolic function, quality of life of~     patients with heart failure. However, CRT and primary ICD was not generalized in Korea. So we~     will register patients who implant CRT or ICD (primary), and follow them up. During scheduled~     follow up, all patients will perform echocardiography, 6 minute walking test, EKG, Holter~     monitoring and questionnaire on QOL.~   "
109097|NCT02139436|"~     Each year, 11,000 people suffer a spinal cord injury (SCI) in the U.S. Within the first year,~     there are profound declines in physiologic function, forming the underlying substrate for~     future cardiovascular disease . In fact, acquired cardiovascular disease is an increasingly~     recognized consequence of SCI and is the leading cause of death in SCI. Though incompletely~     understood, the almost 10-fold prevalence of cardiovascular disease results in part from~     profound physiologic 'detraining' resulting from motor impairment and immobility. Currently,~     effective interventions preventing acute declines that lead to cardiovascular compromise and~     increased risk in SCI are lacking - exercise therapy for those with SCI is challenging and~     when employed, is typically limited to the upper body. Recently, the investigators refined a~     unique form of exercise for those with SCI that specifically mirrors exercise performed by~     those without SCI. Functional Electrical Stimulation (FES) Row Training (RT) couples~     volitional arm and electrically controlled leg exercise, resulting in a hemodynamic profile~     that produces the beneficial cardiac loading conditions of large muscle mass exercise. As~     such, FES-RT may be a safe and effective way to attenuate cardiovascular declines following~     SCI. The investigators aims are to test the overall hypotheses that FES-RT will: 1) mitigate~     against increased visceral adiposity and reduced insulin sensitivity, 2) prevent worsening~     lipid profile and compromised baroreflex function, and 3) counter ventricular wall thickening~     and declining ventricular function occurring with acute SCI, and that these effects will be~     greater than that observed with an arms-only exercise group. Changes with FES-RT will be~     compared to a time (wait-list) control and to arms-only-RT. Individuals with an SCI within~     the last 3-6 months will be randomized to immediate FES-RT, to a time control beginning~     FES-RT after a 6 month wait, or 6 months of arms-only-RT followed by FES-RT. Measures will be~     made at baseline and every 3 months. The investigators work will provide results that clearly~     delineate potential health benefits of FES-RT, and if FES-RT is effective in a majority of~     those with SCI, its application, implementation, and integration could be easily replicated.~   "
109098|NCT02139423|"~     Universal hearing screening at birth by use of otoacoustic emission (OAE) is now offered in~     most maternities in France to detect symptomatic hearing impairment at birth but screening of~     cCMV infection is not coupled with this screening. In this study, the feasibility of~     achieving before one month of age the diagnosis of congenital CMV diagnosis and as well as~     the confirmation of hearing loss in newborns who failed newborn hearing screening will be~     tested.~   "
109099|NCT02139410|"~     Insulin-like growth factor 1 (IGF)-1 is an important neuromyotrophic hormone. Disregulation~     of this hormone has been reported to influence the genesis of cognitive impairment and~     dementia in the elderly patients. We analyzed the possible link between IGF-1 and risk of~     Sarcopenia and Mortality in a cohort of elder patients with cognitive impairment.~   "
109100|NCT02139397|"~     The purpose of this research study is to evaluate an investigational drug (DFMO) in~     combination with bortezomib, for relapsed and refractory neuroblastoma. DFMO is an~     investigational drug because it has not been approved by the U.S. Food and Drug~     Administration (FDA). This study will look at the safety and tolerability of DFMO in~     combination with bortezomib as well as the tumors response to this study drug.~   "
109101|NCT02139384|"~     The purpose of the study is to create a clinical pneumonia tool that can be used to predict~     the cause of community-acquired pneumonia, which is a lung infection that began outside of~     the hospital in critically ill children therefore limiting unnecessary antibiotic use. The~     investigators will enroll critically ill children admitted with acute respiratory failure and~     suspected pneumonia. Each patient will receive a clinical pneumonia score blinded from~     culture and respiratory viral panel results. All care after samples obtained will be at the~     discretion of the PICU team. The investigators believe that our clinical pneumonia scale with~     procalcitonin will accurately designate viral from bacterial etiologies.~   "
137661|NCT01765374|"~     To detect by sonography relapse of disease activity prior to clinical symptoms in RA patients~     treated by rituximab.~   "
109105|NCT02139332|"~     The purpose of this study is to to conduct a randomized controlled trial comparing an~     intervention group and a control group to evaluate the feasibility of the Promoting First~     Relationships method in an American Indian community through their tribal Health Promotion~     program, and to assess the efficacy of the method in this community.~   "
109106|NCT02139319|"~     The purpose of the study is to evaluate the safety and tolerability of the drug product at~     each dose level.~   "
109107|NCT02139306|"~     This is a Phase 3, international, multicenter, randomized, double-blind, placebo-controlled,~     efficacy and safety study of ataluren in patients with nonsense mutation cystic fibrosis~     (nmCF) not receiving chronic inhaled aminoglycosides.~   "
109108|NCT02139293|"~     The purpose of this pilot study is to evaluate the effect of auricular autonomous nervous~     system stimulation on cardiovascular parameters and sympathovagal balance in healthy~     subjects. It is investigated if auricular vagal nerve stimulation affects heart rate~     variability as well as peripheral local blood perfusion, and if this effect depends on the~     site of stimulation in the auricle, whereas four distinct stimulation points are tested.~   "
109109|NCT02139280|"~     No prospective randomized trials have evaluated the most efficacious dose of cyclophosphamide~     to mobilize autologous stem cells. We previously demonstrated that the time to collection of~     autologous hematopoietic stem cells is 10-12 days following the one dose of cyclophosphamide~     and daily G-CSF (granulocyte-colony stimulating factor).9 This prospective randomized trial~     is designed to determine if a lower dose of cyclophosphamide (1.5 gm/m2) will be as~     efficacious as the intermediate dose (3 gm/m2), based on cell number collected, number of~     apheresis required and resource utilization.~   "
109110|NCT02139267|"~     The purpose of this study is to determine the optimal dose of GX-188E for the Phase 3 and~     access the efficacy and safety of GX-188E according the protocol in patients with Cervical~     Intraepithelial Neoplasia 3 (CIN3).~   "
109111|NCT02139254|"~     Gestational diabetes mellitus (GDM) is defined as carbohydrate intolerance with onset or~     first recognition during pregnancy. If insulin resistance and hyperglycemia are recognized~     before pregnancy, the term pregestational diabetes (PGD) is used. In the last years, much has~     been invested to uniformly define worldwide the diagnostic criteria and the management of~     gestational diabetes. A general screening in a low risk population should be implemented into~     routine prenatal care. Similarly, pregnant women at high risk for metabolic disorders should~     be screened in the early pregnancy.~      The aim of the following study ist to investigate the role of first trimester glycosylated~     haemoglobin (HbA1c) of pregnant women with risk factors in developing gestational diabetes~     mellitus (GDM).~   "
109112|NCT02139241|"~     The purpose of this study is to assess the effects of ramosetron on corrected QT interval in~     patients undergoing off pump coronary artery bypass surgery.~   "
109113|NCT02139228|"~     Evaluate the persistency of immune response against Haemophilus influenzae type b by~     assessing anti-PRP antibody levels in children vaccinated with either Hib-CRM197 or Hib-TT~     booster vaccine approximately 4 years before.~   "
109114|NCT02139215|"~     This is a phase IV multicenter trial to evaluate real-world health outcomes and economic~     impact of panitumumab versus standard-of-care (SOC) in the treatment of patients with~     chemotherapy-refractory metastatic colorectal cancer (mCRC).~      The study will enable real-life health economics and outcome research (HEOR) to assess the~     impact of panitumumab in the Quebec population.~      The primary objective is to evaluate real-world health outcomes and economic impact of~     panitumumab in the treatment of patients with chemotherapy-refractory mCRC in comparison with~     SOC. The secondary objectives are to confirm survival data, to assess the quality of life of~     patients and to assess the health care resource utilization of patients.~      Patients with a mutated KRAS gene will be treated with standard-of-care (SOC) and patients~     with a non-mutated (wild type) KRAS gene will be treated with panitumumab.~      During the course of the study, data will be collected on quality of life and work~     productivity. Patients will be asked to fill a set of questionnaires at their recruitment in~     the study and at every 3 months after treatment initiation.~   "
109115|NCT02139202|"~     This is a 6-month pilot study intended to test the effect of financial incentives on~     improving medication adherence in AMI patients; to test the effect on adherence of removing~     financial incentives; and to test the effect on the enrollment rate of modifying recruitment~     procedures.~   "
109116|NCT02139189|"~     The purpose of this CorMatrix P-ECM safety and feasibility study is to evaluate the safety~     and functional effect of the CorMatrix P-ECM.~   "
109117|NCT02139176|"~     In sub-Saharan Africa, engaging men in HIV prevention, care, and treatment has proven~     challenging. Along all steps of the HIV care-seeking cascade, men exhibit worse care-seeking~     behaviors than women. They are less likely to be tested for HIV, initiate combination~     antiretroviral therapy (cART), and be retained in cART care. Additionally, men rarely engage~     in the care of their female sex partners, even though couple care-seeking is associated with~     marked improvements in condom use within HIV-discordant couples. Option B+, Malawi's program~     for providing immediate, lifelong combination antiretroviral therapy (cART) to all~     HIV-infected pregnant women at the time of diagnosis, is an important entry-point for~     involving male partners in care.~      This is a pilot randomized controlled trial (N=200 women) comparing two strategies of male~     partner involvement within the Option B+ program. In both arms (patient referral and contract~     referral) women will be encouraged to invite their male partners to accompany them to the~     clinic for couple HIV counseling and testing. In the contract referral arm, if the couple~     does not present within one week, the male partner will receive a home visit encouraging them~     to present to the clinic. We will compare the two arms for 1) uptake of couple HIV counseling~     and testing (cHCT), 2) uptake of cART for women, and 3) linkage to care for HIV-infected men.~     Results are expected to inform a larger trial and ultimately improve care-seeking in Malawi's~     HIV program.~      Objective 1: Determine acceptability of male partner recruitment for cHTC within an Option B+~     context. We will assess acceptability of eligible females to participate in this pilot RCT~     and reasons for non-participation.~      Objective 2: Assess whether study arm (patient referral versus contract referral) is~     associated with cHTC uptake. We will conduct a pilot randomized controlled trial (RCT) of~     male partner recruitment. This study will contain two arms: patient referral and contract~     referral for uptake of cHTC (primary outcome).~   "
109118|NCT02139163|"~     Long-term objectives of the basic research part are improvement of CAP-management with~     respect to therapy, diagnosis and prevention to contribute to a better care of patients with~     pneumonia.~   "
109119|NCT02139150|"~     The purpose of this study is to see if PET/CT scans that use a radioactive substance called~     [18F] fluorothymidine (FLT), can detect and monitor changes in the tumor. Radioactive~     substances are used with PET/CT scans to see cancer cells, and are also called~     radiotracers. FLT is a new radiotracer that has been given to people in prior studies. FLT~     PET/CT is an experimental scan unlike FDG (fluorodeoxyglucose) PET scan which is a standard~     clinical scan and is commonly used. The investigators would like to know if there is any~     evidence of early treatment response by obtaining FLTPET/ CT scans before and after~     treatment.~   "
109124|NCT02139085|"~     Introduction: Lower extremity Chronic Venous Insufficiency is a prevalent disease that~     adversely affects an individual's Quality of Life. Varicose vein endovenous radiofrequency~     treatment have a lower risk of iatrogenic injuries and offer faster return to work~     activities, when compared with open surgical techniques. Endovenous electrocoagulation can~     selectively and safely cause Great Saphenous Vein (GSV) wall necrosis but its clinical~     results has never been studied before.~      Objective: The objective of this study is to compare Great Saphenous Vein electrocoagulation~     and radio frequency (RF) endovascular varicose vein treatment clinical results and quality of~     life improvement in a prospective double blind randomized controlled clinical trial.~      Methods: Consecutive patients with varicose veins and primary GSV reflux will be randomized~     to Electrocoagulation or Radiofrequency endovenous treatment. The primary outcome measure~     will be GSV occlusion rate at 3 and 6 months after treatment verified by Duplex Scanning~     (DS). Secondary outcome measures will be pain visual analogue scale (VAS), bruising,~     neuropathy and vein thrombosis frequency in the immediate postoperative period (1 week); and~     Clinical Etiology Anatomy and Pathophysiology (CEAP) classification ,Venous Clinical Severity~     Scale (VCSS), and Aberdeen Varicose Vein Questionnaire (AVVQ), obtained preoperatively, at 3~     and 6 months postoperatively. For statistical analysis, we will use the Student's t test, the~     Mann-Whitney test and Pearson's correlation, considering positive statistical significance~     when level of p <0.05.~   "
109125|NCT02139072|"~     The purpose of this study is to see if the CoaguChek XS is accurate in measuring~     International Normalized Ratio (INR) in patients with Antiphospholipid Antibody Syndrome~     (APL) receiving warfarin therapy.~   "
109126|NCT02139059|"~     To compare staged ureteroscopy following initial urinary drainage versus direct ureteroscopy~     without initial urinary drainage in the treatment of obstructive calcular anuria with acute~     renal failure in children.~   "
109127|NCT02139046|"~     The purpose of this study is to evaluate the efficacy and safety of febuxostat 40 mg extended~     release (XR) and 80 mg XR in comparison with febuxostat 40 mg immediate release (IR) and 80~     mg IR, respectively, in participants with gout.~   "
109128|NCT02139033|"~     This study will evaluate the efficacy of Retaine™ ophthalmic emulsion in treating the signs~     and symptoms of dry eye syndrome.~   "
109129|NCT02139020|"~     The investigators will collect plasma samples at baseline, during treatment, and at~     progression.~   "
109130|NCT02139007|"~     This is a pilot study evaluating the recruitment strategies for sites and patients, data~     collection instruments, follow-up procedures, administrative processes, and the proposed~     management strategy for the future large scale national trial.~   "
109131|NCT02138994|"~     This is a 3 to 4 months, multi-site, prospective randomized clinical study of patients~     diagnosed with a chronic wound. The primary objective is to assess changes in healing rate,~     by measuring differences in wound area when treating chronic wounds with the Next Science~     Wound Gel compared to the Triple Antibiotic Ointment Neosporin (Standard of Care, SOC). At~     the end of the study period, patients may continue receiving their assigned study treatment~     provided they have signed the Continuation of Treatment Informed Consent and the rational~     for continuation is documented by the investigator.~   "
109132|NCT02138981|"~     The purpose of this study is to compare the survival outcomes between hepatic resection and~     transarterial lipiodol chemoembolization (TACE) used as the initial treatment in patients~     with Resectable Hepatocellular Carcinoma Beyond Milan Criteria.~   "
109133|NCT02138968|"~     The study intervention improves functional capacity and delays frailty status in pre-frail~     elderly subjects.~   "
109134|NCT02138955|"~     This is a single center in patient/outpatient, uncontrolled dose escalating study in cancer~     patients to evaluate the safety, tolerability and pharmacokinetic (PK) profiles of body~     surface area adjusted doses of liposomal curcumin administered intravenously as an 8 hour~     infusion once weekly for 8 weeks.~   "
109135|NCT02138942|"~     The main objective of this study is to demonstrate that the LIR (Learning Intravenous~     Resuscitator) Closed-Loop Fluid Administration System (hereafter the LIR system), a new~     device for the automated administration of intravenous fluids during major abominal surgery~     and which allows the reinjection of 250 ml of saline filling (crystalloid or colloid),~     maintains blood volume at values that are acceptable by the gold standard, i.e. the~     anesthetist in charge of the patient.~   "
109136|NCT02138929|"~     The goal of this clinical research study is to find the highest tolerable dose of LDE225 that~     can be given in combination with everolimus to patients with esophageal or GEJ cancer. The~     safety of the drug combination will also be studied.~   "
109137|NCT02138916|"~     The purpose of the study is to determine if benralizumab reduces COPD exacerbation rate in~     symptomatic patients with moderate to very severe COPD who are receiving standard of care~     therapies~   "
109138|NCT02138903|"~     Comparing the hemodynamic and cardiac effects of two types of weaning trials of mechanical~     ventilation in ICU patients of two French ICU.~   "
109139|NCT02138890|"~     This double-blind, multicenter, randomized, controlled trial (RCT) will evaluate the efficacy~     of a single dose of Autologous Protein Solution (APS) in patients with osteoarthritis (OA) of~     the knee who have failed at least 1 conservative osteoarthritis (OA) therapy (e.g.~     physiotherapy, simple analgesics, intra-articular injection).~   "
109140|NCT02138877|"~     to compare outcome of pyeloplasty in pediatric population less than 6 months in age using an~     after coming stent versus stentless pyeloplasty.~   "
109141|NCT02138864|"~     The study purpose is to determine the clinical values of 18F-FP-(+)-DTBZ in the diagnosis of~     Parkinsonism in patients with carbon monoxide intoxication, regional distribution and its~     correlation with clinical parameters. This study is expected to be completed in a period of 3~     years.~   "
109142|NCT02138851|"~     The investigators performed a 8-week, randomized, double-blind, placebo-controlled human~     trial to evaluate the efficacy and safety of Fig paste on functional constipation. The~     investigators measured colon transit time, frequency of defecation, defecation time, stool~     type, and abdominal discomfort.~   "
109143|NCT02138838|"~     The primary objective was to evaluate the efficacy of cinacalcet for reducing the plasma~     intact parathyroid hormone (iPTH) level by ≥ 30%.~   "
109144|NCT02138825|"~     To evaluate the efficacy and safety of 26-weeks of treatment with riociguat vs. placebo in~     patients with symptomatic PH (pulmonary hypertension) associated with IIP (idiopathic~     interstitial pneumonias).~   "
109149|NCT02138760|"~     Men with elevated prostate specific antigen bloodtest and prior negative prostate biopsy have~     a 30-60% of harboring occult prostate cancer. Multiparametric magnetic resonance imaging~     (mpMRI) is an imaging test that may improve prostate cancer detection rates in this~     population of men. In this prospective randomized trial multicenter trial the investigators~     will assess the detection rates of prostate cancer diagnosis of systematic biopsy compared~     with the addition of either a computer targeted system (UroNav - InVivo corp) to sample~     suspicious areas identified on mpMRI versus the detection rate mpMRI guided freehand biopsy~     (cognitive fusion biopsy). The hypothesis being tested is that computerized fusion guided~     biopsy (UroNav) will increase detection prostate cancer compared to cognitive biopsy of these~     areas and systematic biopsy alone.~   "
109150|NCT02138747|"~     The purpose of this study was to assess tolerability of mirabegron compared to tolterodine ER~     in the treatment of participants with symptoms of Overactive Bladder (OAB) as well as the~     impact of treatment on micturition frequency and incontinence episodes.~   "
109151|NCT02138734|"~     This is a Phase Ib/II, open-label, dose-finding, multicenter study of intravesical BCG plus~     ALT-803 in Non-muscle invasive bladder cancer.~   "
109152|NCT02138721|"~     The objective of this study is to evaluate the role of local treatment with radical~     prostatectomy in patients with newly-diagnosed metastatic hormone-sensitive prostate cancer.~   "
109153|NCT02138708|"~     The purpose of this study is to assess the predictive performance of the pulmonary vascular~     reactivity to acetylcholine, in the presence pulmonary arterial hypertension (estimated 1~     year after the closure of the shunt).~   "
109154|NCT02138695|"~     1. Purpose of the study~      1) To explore clinical recurrence associated clinical factors including age, sex, clinical,~     electrophysiological, anatomical, imaging, and serologic characteristics.~      2) To develop simulation model to predict clinical recurrence and the efficacy of catheter~     ablation 2. Scientific evidence of the study~        1. In atrial fibrillation patients, the maintenance of normal sinus rhythm showed~          significant reduction of mortality.~        2. drug therapy with anti-arrhythmic drug showed many complications and side effect, thus~          non-drug therapy such as catheter ablation is developed.~        3. catheter ablation has been performed for 10years world-wide, and showed superior~          treatment outcome compared with drug therapy.~        4. clinical outcome after catheter ablation is affected not only by age, sex and underlying~          disease, but also by electrophysiologic, imaging, serologic and electroanatomical~          remodeling of the heart. However, there are few studies concerning these multifactorial~          variables.~      3. Study population~   "
109155|NCT02138682|"~     This investigator initiated trial is designed to measure the accuracy of diagnosis of~     Parkinson disease through the use of DaTscan. Currently, DaTscan is FDA approved to measure~     dopamine transporter densities in human tissue. This measurement can assist in distinguishing~     between Essential Tremor and Parkinsonian Syndromes (idiopathic Parkinson disease,~     Progressive Supranuclear Palsy, Multi Systems Atrophy, etc). This study will compare both~     clinical diagnosis of symptoms and the results of the scan to the pathological diagnosis~     received at time of death. Patients will be registered in the Parkinson Research Institute's~     brain donation program, receive a clinical diagnosis of Parkinson disease, have their brain~     scanned using DaTscan, and donate their tissue for research and autopsy purposes. The~     hypothesis of the study is that DaTscan will diagnosis Idiopathic Parkinson Disease as~     accurately as a clinician.~   "
109156|NCT02138669|"~     The US food and Drug Administration (FDA) originally approved INTACS prescription inserts in~     April 1999 for the correction of low levels of nearsightedness (-1.00 to -3.00 diopters).~     Additional clinical data have shown that INTACS are safe for the treatment of keratoconus, in~     July 2004, FDA approved INTACS inserts for the treatment of keratoconus as a Humanitarian Use~     Device (FDA approval letter attached). The statute and the implementing regulation of FDA (21~     CFR 814.124 (aj) require IRB review and approval before a HUD is used.INTACS prescription~     inserts are composed of two clear segments, each having an arc length of 150°, they are~     manufactured form a biomedical material called polymethylmethacrylate (PMMA) and are~     available in three thicknesses. Two INTACS inserts ranging from 0.250mm to 0.350mm may be~     implanted depending on the orientation of the cone and the amount of myopia and astigmatism~     to be reduced.~   "
109157|NCT02138656|"~     The purpose of this study is to investigate whether a course of chiropractic treatment has a~     significant impact on the natural course of infantile colic, specifically:~        1. Do parents of colicky infants randomised to the groups receiving a course of McTimoney~          chiropractic treatment:~             -  report a significantly greater improvement in hours of crying than those in the~               control group?~             -  report a significantly greater improvement their own quality of life (anxiety and~               depression)?~             -  report resolution of colic following treatment than the control group?~        2. What effect does parental blinding have on parentally-reported symptoms of infantile~          colic and parental quality of life?~      The study will also include exploratory investigations to determine whether there are:~        1. Any particular groupings of patient characteristics (for example; 'other' presenting~          symptoms, position in the natural course of colic, age of onset, spinal dysfunction,~          perinatal factors) that are associated with good or poor outcomes~        2. Any particular characteristics of the treatment (e.g. specific adjustments) that are~          associated with good or poor outcomes.~   "
109158|NCT02138643|"~     Achalasia is a disorder benign esophageal motor, which is characterized by failure to relax~     the lower esophageal sphincter ( LES) in response to swallowing associated with lack of~     peristalsis of the esophageal body. Its most common clinical presentation is dysphagia , and~     occasionally chest pain , regurgitation , aspiration pneumonia and weight loss , resulting in~     a large impact on daily activities and quality of life of affected individuals .~      There is currently considered curative treatment for achalasia , dysphagia relief being the~     primary therapeutic target and is forced to relax the LES by endoscopy or surgery. Thus , the~     most commonly used endoscopic treatments are forced dilatation of the cardia and botulinum~     toxin. Laparoscopic Heller myotomy with antireflux procedure with therapy is considered gold~     standard  because of excellent results and minimal invasiveness. Currently , pneumatic~     dilation and surgical treatment with the Heller myotomy with fundoplication are strongly~     associated with the best therapeutic options available .~      In recent years, the possibility of using endoluminal access in the treatment of achalasia~     patients through the technique originally described as Natural orifices Translumenal~     Endoscopic Surgery ( NOTES) and continuing advances in the submucosal dissection has enabled~     the concomitant development of a new approach described as perioral endoscopic myotomy . In~     2007, Pasricha et al , described the feasibility of endoscopic esophageal myotomy through a~     submucosal tunnel initially in an animal model . The first performance of this procedure in~     humans was described by Inoue et al , in 2010 , introducing the concept of transluminal~     endoscopic surgery through natural orifices , with the objective of minimizing the trauma and~     all the stress resulting from open surgical procedure . These authors call the procedure as~     POEM ( Per Oral Endoscopic myotomy ) .~   "
109159|NCT02138630|"~     Capsaicinoids (the active ingredient in hot peppers) have been shown to cause a moderate~     increase in energy expenditure (50 kcal/day) as well as reductions in appetite, energy~     intake, and (visceral) adiposity. As such, there is considerable interest in capsaicinoid for~     weight loss supplements. Owing to the fact that these changes are believed to be driven by~     catecholamine release and alterations in fat oxidation, there is growing belief that~     capsaicin may also offer potential ergogenic benefits (performance enhancement) during~     exercise, similar to the affect of caffeine, which works through similar pathways. Of~     particular interest are the recent findings that free-fatty acids in the blood are elevated~     2-2.5hrs post ingestion, yet changes in typical cardiovascular or sympathetic nervous tone~     indicators (heart rate, blood pressure) were unaffected, suggesting some of the negative~     consequences of other stimulants may be avoided. At present, however, more in depth~     investigations of the effects on endothelial function, vascular autonomic tone and~     inflammation are lacking.~      Although there are some indications that capsaicinoid ingestion may alter factors associated~     exercise performance (such as increased fat oxidation for glucose sparing), to date these~     studies have primarily used very low exercise intensities wherein these effects are typically~     unnecessary, and results are not generalizable to the typical race intensities of endurance~     sport competition. Performance measures have also been a noticeably absent outcome from~     research to date.~      Hypotheses: 1), Exercise performance will improve, at a level similar to those demonstrated~     for caffeine ingestion 2) ratings of perceived exertion will go down with the effect of~     causing intensity to go up 3) During sustained aerobic activity approaching the aerobic~     threshold alterations in substrate use will be minimal (but possibly meaningful in regard to~     performance); alterations at rest will be more pronounced. 4) acute alterations (6o min post~     single dose) in blood pressure, HRV, arterial stiffness and RMR will mirror the effects~     observed for more prolonged exposure in phase 1.~   "
109160|NCT02138617|"~     This study involves standard combination chemotherapy treatment for colon cancer,~     5-Fluorouracil (5FU), leucovorin and irinotecan (known as FOLFIRI), plus bevacizumab~     (Avastin). The study is designed to test the FOLFIRI regimen based on certain characteristics~     of a person's genetic makeup or genes. Genes are made of DNA and determine not only~     inherited traits or appearance (hair and eye color, height, body type, etc.) but also play an~     important role in health and how the body responds to illness and treatments for those~     illnesses.~      In this study, the investigators will examine the relationship between a patient's genes~     (DNA), or genotype, and how the patient's body breaks down and removes or metabolizes the~     anti-cancer drug irinotecan. Circulating blood level of irinotecan plays an important role in~     how well this drug works against a patient's cancer as well as the adverse side effects the~     patient may experience. The current standard dose of irinotecan was determined in clinical~     trials without knowing individual genotypes and thus does not take into account a patient's~     ability to metabolize irinotecan. This means that based on one genotype the current standard~     dose of irinotecan may be correct or based on other genotypes the standard dose could result~     in lower and possibly less effective blood levels and result in significant under-dosing of~     irinotecan.~      Based on genotype the patient will be assigned to one of the following doses of irinotecan:~        -  180 mg/m2 (standard dose)~        -  260 mg/m2~        -  310 mg/m2~      The purpose of this research study is to determine if dosing irinotecan based on genotype is~     effective and safe for patients with colon cancer. Patient genotype will be determined from a~     small sample of blood and a laboratory test or assay performed at UNC Laboratories. For the~     purpose of this study, this assay is new and considered to be investigational. This means~     that the genotype assay used in this study has not yet been approved by the FDA for~     determining irinotecan dose levels in patients with colon cancer.~   "
109161|NCT02138604|"~     Most patients presenting to the emergency department with chest discomfort have a nonischemic~     ECG and biomarkers of myocardial necrosis within normal limits. These patients are routinely~     admitted to hospital because of diagnostic uncertainty for occult MI or ischaemia.~      Acute myocardial ischemia is associated with acute mycardial dysfunction We tested a~     non-invasive plethysmographic arterial pressure change index of myocardial performance~     (dP/dt) that could be added to the diagnostic triage of ischaemia in the ER avoiding~     unnecessary admissions.~   "
109162|NCT02138591|"~     Vitamin D (Vitamin D) deficiency is very common. We recently showed that 97% of 204 patients~     admitted to Truman Medical Center were Vitamin D deficient (<30 ng/ml). However, the~     consequences of Vitamin D deficiency, particularly with respect to infection, are not well~     understood. It is known that production of cathelicidin, an important antimicrobial peptide,~     is critically dependent upon Vitamin D. It is also established that levels of cathelicidin~     correlate inversely with urinary tract infection risk. We hypothesize that restoration of~     Vitamin D levels to normal in patients undergoing major surgery will result in significant~     decreases in levels of perioperative infections due to restoration of normal levels of~     circulating Vitamin D, which in turn will elevate cathelicidin levels. As an initial test of~     this hypothesis, we propose a double-blind, prospective, randomized study of pre-operative~     Vitamin D supplementation. Fifty subjects undergoing surgery will receive daily Vitamin D3~     (50,000 IU) for five days pre-operatively, with controls receiving placebo. Levels of Vitamin~     D, calcium, cathelicidin, and the pro-inflammatory protein resistin, will be monitored before~     Vitamin D supplementation (pre-operatively) and after Vitamin D supplementation~     (post-operative days 1 and 2). The effect of these changes should be to decrease the~     incidence of infectious complications. We expect to observe Vitamin D levels increase to~     normal, and cathelicidin levels become elevated. We expect to see increased levels of~     resistin in patients developing infections. This study will provide strong pilot evidence for~     future NIH funding.~   "
109163|NCT02138578|"~     This study will assess whether Stereotactic Body Radiation Therapy (SBRT) can provide~     comparable local control, with similar or improved toxicity rates compared to Radio Frequency~     Ablation (RFA) when treating small renal cell carcinomas.~   "
109164|NCT02138565|"~     Primary hypothesis:~      A large reduction in weight is not associated with a change in accurately measured glomerular~     filtration rate (GFR) (51Chromium ethylenediaminetetraacetic acid plasma clearance~     (51Cr-EDTA)).~      Secondary hypothesis:~      A large reduction in weight is associated with a greater change in estimated GFR (The~     Modification of Diet in Renal Disease (MDRD-formula)) than in accurately measured GFR.~      Other formulas for estimated GFR (Cockcroft Gault, Chronic Kidney Disease Epidemiology~     Collaboration (CKD-EPI), CKD-EPI with cystatin C) are better correlated with accurately~     measured GFR.~   "
109165|NCT02138552|"~     The objective of this clinical trial is to identify the most efficacious octenidine~     dihydrochloride concentration regarding bacterial count reduction in comparison to a placebo~     in the oral cavity.~   "
109166|NCT02138539|"~     The purpose of this study is to evaluate the effectiveness and tolerability of an herbal~     de-pigmenting regimen applied to one side of the face compared with hydroquinone applied to~     the other side of the face in treating mottled hyperpigmentation and melasma.~   "
109175|NCT02138422|"~     The primary objective of this study will be to assess how effective Xilonix is in the~     treatment of patients with symptomatic colorectal cancer. By blocking a substance that helps~     tumours grow and spread, Xilonix therapy may not only slow tumour growth, but also may~     improve symptoms of muscle loss, fatigue, appetite loss, and pain in patients with colorectal~     cancer. The effectiveness of the therapy will be measured by assessing the change in these~     symptoms for patients treated with Xilonix versus those treated with placebo. Reversal of~     muscle loss will be assessed with a type of X-ray called a DEXA scanner. Improvement in pain,~     appetite loss, and fatigue will be measured with a questionnaire that is completed by~     patients enrolled on the trial.~   "
109167|NCT02138526|"~     Pazopanib (Votrient) is registered for the treatment of patients with advanced renal cell~     carcinoma and patients with soft tissue sarcoma who have received prior chemotherapy. It is~     administered at a fixed oral dose of 800 mg once daily (OD) regardless of size, age and~     clinical condition. It is absorbed from the gastrointestinal tract with an oral~     bioavailability of ~21%. Pazopanib is practically insoluble and highly permeable. When~     ingested with high fat food the pazopanib exposure (area under the concentration time curve~     (AUC)) is doubled. Common adverse effects are diarrhea and nausea. This might be caused by~     the non-absorbed proportion of pazopanib. A reduced dose taken with food could be a possible~     approach to reduce these side effects. Therefore the investigators initially want to~     determine the equivalent reduced dose of pazopanib when taken with a continental breakfast.~     Thereafter the investigators want to investigate whether the intake with food reduces the~     frequently reported side effects nausea and diarrhea.~   "
109168|NCT02138513|"~     Mindfulness-based cognitive therapy has been demonstrated to be effective in reducing~     anxiety, depression and fatigue in cancer patients. As this intervention can be offered in~     groups, costs are relatively low. In addition, delivering MBCT online might make the~     intervention more accessible and cost-effectiveness. However, more information is needed~     about what treatment works best for which patient.~      Therefore, the aim of this study is to investigate clinical and cost-effectiveness of both~     individual MBCT online and MBCT offered as a group training compared to TAU .~      Study design: The design of the study will be a multi-centre, randomised, superiority trial,~     comparing MBCT online and MBCT offered as a group training with TAU. Participants in the TAU~     condition will be randomised to one of the treatment conditions after 3 months. Main~     assessments will take place at baseline (T0), post-treatment (T1), and 3 (T2) and 9 months~     after post-treatment (T3).~      We expect the MBCT conditions to be superior to TAU in terms of improving mindfulness skills,~     anxiety and depressive compants, psychological well-being, rumination and fear of cancer~     recurrence. We also expect the MBCT to result in patients returning to work earlier, have a~     higher work ability and have lower medical care costs, thereby being more cost-effective than~     TAU.~   "
109169|NCT02138500|"~     This study will see how PF-06372865, an experimental drug distributes in the brain after one~     dose of PF-06372865 is administered orally to healthy volunteer subjects. The study will also~     evaluate the safety and tolerability of PF-06372865in these subjects and will measure the~     level of PF-06372865 in the blood.~   "
109170|NCT02138487|"~     The investigators are conducting a study to better understand the relationship between~     activity restrictions and women's satisfaction following urogynecologic surgery for prolapse.~     We hypothesize that women with less stringent postoperative restrictions will have higher~     levels of satisfaction 12 weeks following surgery with no difference in respect to anatomic~     outcome.~   "
109171|NCT02138474|"~     Chronic tension-type headaches (CTTHs) affect 30-40% of the population and account for a~     number of absences from, and decreased performances at, work and school as well as~     recreational activities. CTTHs typically occur at least 15 times a month or at least every~     second day, and present as an achy or tight sensation that is felt around the head . The pain~     may last from 30 minutes to several days and varies in intensity . Conventional treatment is~     palliative, consisting of analgesics and non-steroidal anti-inflammatory drugs (NSAIDs),~     which may produce adverse effects and analgesic rebound headaches . Lacticum acidum 30CH is a~     homoeopathic remedy that has been shown to have potential benefits in the treatment of CTTHs~     . Homaccords are the preparation of one remedy in multiple increasing potencies in a single~     vehicle . There has been no research done to date on Lacticum acidum Homaccord in the~     treatment of CTTHs.The aim of this study is to determine the efficacy of Lacticum acidum~     Homaccord in the treatment of chronic tension-type headaches, using the modified Headache~     Diary and the Headache Disability Inventory.~   "
109172|NCT02138461|"~     This study examines patient perceptions regarding the tolerability of two classes of glaucoma~     medication: bimatoprost and latanoprost.~   "
109173|NCT02138448|"~     Cancer screening can improve the length and quality of life, yet the average American~     receives only half of recommended services. Patient-centered personal health records with~     higher levels of functionality, combined with practice redesign to make use of these~     functions, can help patients obtain recommended cancer screening tests by linking them to~     their doctor's records, explaining information in lay language, displaying tailored~     recommendations and educational resources, providing logistical support and tools to~     stimulate action, and generating reminders. This project will measure whether making these~     resources available to primary care practices and patients promotes shared decision-making~     and increases the delivery of cancer screening compared to existing information systems.~   "
109174|NCT02138435|"~     Isolated ventricular septal defect (VSD) is a well know congenital heart anomaly. If~     discovered in infancy or early childhood surgical intervention can be of necessity depending~     on the size of the defect, to assure a healthy adulthood. The long-term results of surgical~     closure of VSD in childhood are good and after surgery the children are considered as equally~     healthy and physically fit as their peers. However, there is inconsistency in data regarding~     follow-up on this group of patients, in relation to exercise capacity as a measure of the~     cardiopulmonary function. To further approach this matter the post-operative cardiac factors~     of these patients have to be investigated.~      With this study the investigators intend to examine the long-term outcome on cardiac output~     after heart surgery in VSD-patients. It presents an opportunity to also evaluate the~     correlation between cardiac output determined by gas-exchange and by MRI. The overall~     objectives of this study are to 1) examine whether VSD-operated patients have reduced cardiac~     output during exercise in comparison with matched controls, and furthermore 2) to evaluate a~     correlation between cardiac output measured by MRI and cardiac output determined by~     gas-exchange.~      The project is designed as a long-term follow-up and method study. A cohort of 20 children~     who in the 1990's underwent surgical closure of a congenital VSD will be asked to participate~     in this study. An equal amount of healthy young adults, will function as control group. Each~     participant will complete two different exercise tests, a MRI of the heart during lower body~     exercise on a supine ergometer bicycle, and a Supine ergometer bicycle exercise test. This~     data can be used for comparing cardiac output between the test groups, and furthermore it~     allows an evaluation of the correlation between the two methods.~      VSD is as described, the most common congenital heart anomaly. If not intervened with in~     childhood, it can cause severe heart complications later in life. It is unclear whether this~     intervention can cause long-term impact on patients exercise capacity, and for that reason it~     is of great importance that we strive for improving our knowledge of the long-term~     postsurgical outcome after VSD-closure.~   "
109215|NCT02137902|"~     This study aims to identify effective and cost-effective interventions for tobacco use and~     other risk behaviors for cardiovascular disease among Alaska Native people in rural villages.~     In a randomized controlled trial, the study will compare interventions using telemedicine to~     promote the American Heart Association's identified ideal health behaviors (nonsmoking and~     physical activity) relative to ideal health factors (managing cholesterol and blood~     pressure).~   "
109216|NCT02137889|"~     This study will assess the safety and preliminary efficacy of escalating doses of VAY736 in~     relapsed or refractory CLL patients.~   "
109176|NCT02138409|"~     Participants will be selected from patients who have been scheduled at the site for treatment~     of chronic pain without sedation. They will receive either fentanyl sublingual spray or a~     matching placebo sublingual spray that delivers no medication.~      Participants may take pain killers at any time after the procedure for pain relief. They will~     be given a diary card, which they will take home. They will record the name of the medication~     taken, the time, and dosage.~      The study coordinator will call participants about 24 hours after the procedure to collect~     information from the diary card and follow up information about pain and side effects~     (adverse events) after they left the site.~   "
109177|NCT02138396|"~     The objective of this study is to compare the rate of absorption and bioavailability of~     fentanyl sublingual spray 400 mcg to fentanyl citrate 100 mcg by intramuscular injection.~   "
109178|NCT02138383|"~     The main purpose of this study is to find out the dose of enzalutamide that can be safely~     given with gemcitabine and nab-paclitaxel in patients with advanced pancreatic cancer.~     Researchers also want to find out the side effects of these drugs when given together. This~     study will help in finding out the effect on tumor of the combination of enzalutamide,~     gemcitabine and nab-paclitaxel. In the first part of the study, different doses of~     enzalutamide will be tested. In the second part of the study, all patients will be started at~     the same dose of enzalutamide.~   "
109179|NCT02138370|"~     Surgery still remains the mainstay of treatment for localized colorectal cancer. However,~     nearly 30% of patients with localized colorectal cancer (stage II and stage III) will present~     with recurrence. Tumor progression is mediated by both intrinsic genetic changes and by~     extrinsic epigenetic and host environmental factors, including interactions with the immune~     system. Several studies demonstrated that tumor infiltrating memory T-cells and type, density~     and location of infiltrating T cells are better predictors of disease-free survival in~     patients with CRC compared to the standard TNM staging. These data suggest that tumor~     invasion and progression are more accurately predicted by immune response in the primary~     tumor. In addition, mismatch repair (MMR)-deficient tumors are characterized a priori by a~     higher frequency of tumor infiltrating lymphocytes and are associated with significantly~     improved prognosis. Recently, Stotz et al showed that the preoperative lymphocyte to monocyte~     ratio in peripheral blood samples predicts clinical outcome in patients with stage III colon~     cancer. So far there is no comprehensive analysis of the immune-landscape in CRC.~      The aim of the current project is to identify a comprehensive panel of immunomarkers in~     localized colorectal cancer (stage II and stage III) applicable for the detection of patients~     at high risk of recurrence. For the first time, specific tumor-infiltrating immune cells,~     mismatch repair protein expression in tumor tissue and preoperative blood based inflammatory~     markers from routine blood counts in corresponding peripheral blood samples and known~     clinicopathological features will be correlated with outcome in 300 localized CRC patients.~   "
109180|NCT02138357|"~     The primary objective of the study is to determine whether Butrans Transdermal System (BTDS)~     reduces RLS symptom severity in patients with moderate to severe idiopathic RLS who are naïve~     to opiate treatment.~      The secondary objective of the study is to investigate the effects of BTDS on mood, sleep,~     and quality of life.~      The study will consist of nine visits. Depending on the need for medication titration, there~     may also be two scheduled telephone contacts.~      Visit 1: This is a screening visit to determine study eligibility. Eligible subjects who~     choose to participate must undergo medication washout as described in the detailed protocol~     between visits 1 and 2.~      Treatment period #1 (Visits 2 - 5; day 0 - 28): Baseline measures will be recorded and~     subjects randomized to treatment order at visit 2 (day 0). Study medication as well as rescue~     medication (l-dopa, a non-blinded active treatment to be used within a limited dose range as~     described in the detailed protocol) will be dispensed. Subjects will begin treatment period~     #1 immediately after this. The study medication will be titrated within the allowed range~     according to subject's reported symptoms during visit 3 (day 7), visit 4 (day 14), telephone~     contact (day 21). Visit 5 will occur on day 28 and will include assessment of outcome~     measures for the first treatment period. Visit 5 will also mark the beginning of the second~     treatment period.~      Treatment period #2 (Visits 6 - 8; day 28 - 56): Procedures will be similar to those~     described above during treatment period #1. Visit 8 will mark the end of the second treatment~     period during which outcome measures will be ascertained.~      Follow up visit (Visit 9; day 70): This will be a safety follow-up visit approximately two~     weeks after visit 8 for review of adverse events.~   "
109181|NCT02138344|"~     Development of neuropathic pain is one of the most disabling sequels after spinal cord injury~     (SCI) and in peripheral nerve diseases. The functionality of the pain pathway in humans as~     well as its plastic changes following SCI can be assessed in vivo by surface~     electrophysiological recordings and functional magnetic resonance imaging after noxious heat~     stimulation of the skin. Aims: a) establishing a clinically applicable assessment of the pain~     pathway and characterizing its changes as a consequence of SCI and in peripheral nerve~     diseases in an objective manner, b) characterizing plastic changes in the pain pathway in SCI~     patients with neuropathic pain and in patients with peripheral nerve diseases and relating~     them to the development of neuropathic pain syndromes.~   "
109182|NCT02138331|"~     Type 1 diabetes mellitus is strictly autoimmune mediated disease destructing the islets~     β-cell of the pancreas. Mesenchymal stem cells and its microvesicles are reported as an~     anti-inflammatory agents. We hypothesis that intravenous infusion of cell free umbilical~     cord-blood derived MSC microvesicles may reduce the inflammatory state and hence improve the~     β-cell mass as well as the glycemic control of the patients of T1DM.~   "
109191|NCT02138214|"~     This phase II trial studies how well thyroid gland removal with or without central lymph node~     dissection works in treating patients with thyroid cancer or suspected thyroid cancer that~     has not spread to the lymph nodes (randomized into Arms I and II). Arms I and II are compared~     to a standard of care (SOC) Arm III to enable comparison of quality of life among various~     surgical treatments. Currently, the standard treatment for thyroid cancer is total~     thyroidectomy, or complete removal of the thyroid. The lymph nodes in the central part of the~     neck may also be surgically removed, called central lymph node dissection. Prophylactic~     removal of the lymph nodes may increase the risk of life-threatening complications, and may~     reduce post-surgery quality of life. It may also prevent the cancer from returning and reduce~     the need for additional surgery. It is not yet known whether recurrence rates and~     complication levels are lower after thyroid gland removal alone or with central lymph node~     dissection.~   "
109183|NCT02138318|"~     Patients with ulcerative colitis (UC) have an increased risk for colorectal cancer (CRC)~     compared to the general population. Regular screening by colonoscopy is an internationally~     recommended cancer prevention strategy. Random sampling of the mucosa throughout the colon~     has been the mainstay of conventional surveillance practice to detect abnormalities, known as~     dysplasia which can progress to CRC. This requires multiple biopsies, to be taken and~     processed, a practice which is is tedious, expensive, time consuming and has a low pickup~     rate. Dysplasia in UC is typically flat and patchy and can be easily overlooked with standard~     conventional white light colonoscopy (WLC).~      Detection can be improved by the application of dyes which highlight more subtle~     abnormalities. This practice, known as chromoendoscopy (CE) is better than WLC at dysplasia~     detection but more time consuming for the patient and cannot guarantee that the whole colon~     is covered. CE has only been compared in clinical trials with standard definition endoscopy~     rather than the recently available high definition endoscopes with better resolution and~     picture. High definition (HD) endoscopy uses a high definition onitor and a high resolution~     CCD (charge coupled device) providing much better images than standard video endoscopy. HD~     colonoscopy promises therefore to provide an alternative to CE in UC surveillance without the~     need for the extra time and experience required for dye spraying for both endoscopists and~     nursing staff.~      The investigators plan to do a randomized trial to assess HD colonoscopy alone compared to~     chromoendoscopy (with HD colonoscopies) for dysplasia detection during surveillance for~     ulcerative colitis. There have been no trials comparing these two modalities and the~     investigators hope to provide evidence that the additional benefit of CE over HD colonoscopy~     would be marginal and therefore CE would be reserved for procedures using standard definition~     scopes.~   "
109184|NCT02138305|"~     Visual assessment of a coronary artery narrowing (called stenosis) seen on angiography is~     conventionally used to infer how likely the stenosis will limit blood flow (called ischemia)~     under conditions of increased demand (e.g exercise). This is based on animal work and data~     from humans with simple single vessel disease with no co-existing conditions. These data have~     been extrapolated to more complex patients/ complex disease but clearly over-simplifies the~     situation in the majority of patients cardiologists treat.~      Pivotal work by DeBruyne, Pils and colleagues in the 90's convincingly showed that pressure~     derived measurements, called FFR, from the coronary artery during a cardiac catheterization,~     more accurately identify stenoses that would cause ischemia compared to visual assessment~     alone. A strategy of FFR guided coronary stenting with drug eluting stents significantly~     improved outcomes and reduced costs compared to visual assessment alone (FAME trial).~     Deferring treatment based on FFR has been shown to be safe (DEFER Trial). FFR has excellent~     sensitivity and specificity. A FFR of <=0.80 was used as this identified ischemia causing~     lesions 90% of the time. Therefore, the concept of FFR guided percutaneous revascularisation~     and treatment deferral has a robust evidence base to support it.~      Coronary bypass grafting (CABG) is traditionally based solely on a visual assessment of~     angiography images. SPY® Infrared Fluorescence Angiography (NIRF, FDA approved 2005) is used~     by some cardiac surgeons to assess the patency of bypass grafts in real-time in the operating~     room, as a surrogate for immediate traditional coronary angiography. Dr. Ferguson observed~     that regional myocardial perfusion (RMP) image data was also captured in these video~     sequences.~      Study Hypotheses:~        1. In patients who are likely CABG candidates, target vessel epicardial coronary arteries~          (TVECAs) with FFR > 0.80 will not demonstrate an increase in RMP despite an anatomically~          patent bypass conduit during SPY® imaging.~        2. In TVECAs with an increase in RMP during SPY® imaging, cardiac catheter laboratory~          measures of coronary physiology from that TVECA, namely one or a combination of FFR,~          CFR, HSR and HMR, will correlate with the SPY® data on myocardial perfusion, and suggest~          a potential mechanism for this physiologic response to TVECA grafting.~   "
109185|NCT02138292|"~     The study is a prospective, single-arm, one-site therapeutic trial of the combination of~     trametinib plus digoxin for advanced melanoma. endpoints are toxicities assessed by nCi CTCae~     v4.1 within the first 8 weeks, responses measured by ReCiST v1.1 criteria every 8 weeks with~     scans and exams, tumor sensitivity to the drug combination quantified by tumor regressions in~     nSG mice, and correlations of response with tumor sensitivity, BRaF status, MaPK inhibitor~     exposure history, and tumor sodium pump expression.~      Treatment Dosage and administration~      Study Drugs:~        1. Trametinib (2mg) will be administered orally on a daily basis.~        2. Digoxin (0.25mg) will be administered orally on a daily basis.~      on a 8-week cycle, duration of treatment can last from 8 to 104 weeks.~      endpoints~        1. Toxicities will be assessed via nCi's CTCae v4.1 toxicity criteria. DLTs will be defined~          based on the rate of drug-related (definitely or probably) grade 3-5 adverse events~          experienced within the first 8 weeks of study treatment. The MTD will be exceeded if~          more than 20% of patients on the study experience DLTs.~        2. Responses will be measured by ReCiST v1.1 every 8 weeks. Response duration will be~          defined as time from first documented response until disease progression. PFS is time~          from treatment until disease progression.~        3. Patient tumor sensitivity to the drug combination will be quantified by the amount of~          subcutaneous established tumor growth inhibition in nSG mice by 5d/week oral gavage with~          drugs.~        4. Tumor nRaS status will be determined by tumor Dna extraction, PCR amplification of exons~          and Sanger sequencing of nRaS.~        5. History of prior MaPK inhibitor therapies will document MeK inhibitor exposures.~        6. Sodium pump subunit expression will be analyzed by pretreatment tumor~          immunohistochemistry and a qualitative 0 to 3+ grading system.~   "
109186|NCT02138279|"~     The primary objective of this clinical study is to collect clinical data to support FDA~     510(k) submissions for the Topcon CT-800, CT-1, CT-1P and TRK-2P non-contact tonometers. The~     secondary objective is to evaluate any adverse events found during the clinical study.~   "
109187|NCT02138266|"~     The primary objective of this clinical study is to collect clinical data to support an FDA~     510(k) submission for the Topcon Specular Microscope SP-1P. The secondary objective is to~     evaluate any adverse events found during the clinical study.~   "
109188|NCT02138253|"~     This is a double-blind, multicenter study involving patients with chronic HCV infection who~     had a liver transplantation; developed HCV-related liver fibrosis and/or incomplete~     cirrhosis; achieved a sustained virologic response (SVR) following anti-HCV therapy; but~     still have fibrosis and/or incomplete cirrhosis on liver biopsy to see if treatment with~     IDN-6556 is better than placebo in reversing or stopping the progression of the damage to the~     new liver caused by HCV.~   "
109189|NCT02138240|"~     The 1.2 million households living in public housing are disproportionately affected by~     obesity, where prevalence is estimated at 50%. An ecologic framework hypothesizes that this~     disparity is related, in part, to social and environmental factors within these neighborhoods~     that influence residents' lifestyles. Social networks and the built environment may work~     together to promote or inhibit lifestyle behaviors; however, combined social network-built~     environment interventions have not previously targeted changes in diet. Investigators~     hypothesize that an intervention that combines a social network approach with strategies that~     address public housing residents' challenges related to the built environment will improve~     dietary habits. The investigators' overall aim is to develop a combined social network-built~     environment intervention to reduce intake of beverages high in added sugars and to pilot test~     the intervention among residents of public housing developments in Baltimore, MD. The~     investigators' aim for this work is: 1) To develop a combined social network-built~     environment intervention to reduce intake of beverages high in added sugars and to pilot test~     the intervention among residents of public housing developments in Baltimore, MD.~     Investigators hypothesize that a social network intervention will be feasible and acceptable~     in promoting healthy lifestyle change, and that this intervention will alter lifestyle~     behaviors among public housing residents.~   "
109190|NCT02138227|"~     The purpose of this study is to evaluate the efficacy and generalizability of a communication~     intervention (Communication Effectively about Donation (CEaD)) for Organ Procurement~     Organization (OPO) staff requesters and to compare two conditions of delivering the CEaD. The~     experimental design will test: (1) the overall efficacy of the intervention on timely~     referral and consent for organ donation and (2) whether a completely autonomous condition (no~     outside training assistance) is clinically equivalent to the assisted condition (training~     provided by outside consultants) in terms of the final outcome of consent to donation.~   "
109192|NCT02138201|"~     The exact innervation of the bladder and the changes after a spinal cord injury have been not~     yet been illustrated.~      Diffusion tensor imaging with magnetic resonance imaging is a new technique which can be used~     to visualize single nerve fibers, and thus represent the neural supply of a region in vivo.~     There are studies in which both the sacral plexus and the lumbar nerve roots have been~     represented using diffusion tensor imaging. However, there is no study concerning the~     innervation of the bladder.~      The investigators are therefore using diffusion tensor imaging with magnetic resonance~     imaging to represent the bladder innervation of individuals with neurogenic lower urinary~     tract dysfunction and individuals with normal bladder function.~   "
109193|NCT02138188|"~     The Continuous Subcutaneous Insulin Infusion (CSII) might have an impact on psychological~     distress and some psychological factors might be predictors of metabolic control; however,~     very few studies conducted so far were specifically focused on the psychological aspects of~     CSII therapy in adults affected by T1DM.~   "
109194|NCT02138175|"~     The purpose of the study is to determine whether noninvasive hemoglobin monitoring is~     sensitive and accurate enough to detect a significant downward trend in hemoglobin in~     patients at risk for significant bleeding. If this can be shown, it has the potential to~     spare patients multiple invasive blood draws as well as allow for earlier detection of~     significant blood loss and therefore positively impact on patient morbidity and mortality.~     Additionally, it may represent significant financial cost savings in that it may allow for~     patients to be monitored in a non-intensive care unit setting.~      This will be an observational study. The continuous hemoglobin monitor will be connected to~     the patient and hemoglobin measurement data will be collected. Routine laboratory hemoglobin~     monitoring will occur concurrently at a pre-specified frequency as well as at the physician's~     discretion based on usual clinical information. The physician will be blinded to the~     continuous hemoglobin monitoring readings and therefore patient care will not be affected by~     the use of the monitor. Once the study has ended, the data will then be analyzed to assess~     for correlation between continuous hemoglobin monitoring readings and laboratory hemoglobin~     measurement.~   "
109195|NCT02138162|"~     The influence of severely diminished liver function on the metabolism, safety, and~     tolerability of a single oral dose of enzalutamide in a group of 8 men. The results are~     compared to the data gained from 8 age- and BMI-matched men with normal liver function.~   "
109196|NCT02138149|"~     Spinal cord injury (SCI) almost always affects bladder function as well. As a result of this~     bladder dysfunction, individuals with SCI have to undergo regular invasive examination of~     their bladder function (urodynamic examination).~      The nerve growth factor (NGF) is released from smooth muscle cells of the bladder, and there~     are reports, that the concentration of NGF is elevated in the urine of patients with bladder~     dysfunction. The NGF concentration can also be measured in the blood. The concentration of~     NGF in the blood and urine of SCI individuals has not yet been investigated. These~     concentrations may correlate with the severity of bladder dysfunction, and may thus be used~     to replace or at least reduce the number of the more invasive urodynamic examinations.~      The hypothesis that urine and blood NGF concentrations in individuals with SCI are higher~     compared to individuals with healthy bladder function will be tested.~   "
109197|NCT02138136|"~     A study of the long-term safety and efficacy of Lubiprostone in subjects aged ≥ 6 to < 18~     years diagnosed with Functional Constipation~   "
109198|NCT02138123|"~     In this study, the investigators introduce a surgical procedure called IOL-shell technique~     in the purpose of reduce complications of surgeries for dense cataract, and report a~     prospective randomized controlled study aiming at assessing efficacy and safety of the~     IOL-shell technique, which showed that the new procedure offered a safer way for hard~     cataract surgery over the conventional phacoemulsification procedure without compromise in~     efficacy.~   "
109199|NCT02138110|"~     -  To evaluate whether the Scaffold is safe and demonstrates probable benefit for the~          treatment of complete T2-T12/L1 spinal cord injury .~        -  This is a Humanitarian Device Exemption (HDE) Probable Benefit Study to demonstrate~          safety and probable benefit in support of future studies and an HDE application with~          subsequent approval.~   "
109200|NCT02138097|"~     This protocol is for a series of descriptive analyses conducted within a cohort of patients~     using linagliptin, other dipeptidyl peptidase-4 (DPP-4) inhibitors, and other oral and~     non-insulin injected hypoglycemic medications between May 2011 and July 2012.~      Understanding 1) the existing utilization patterns for linagliptin, sitagliptin, saxagliptin,~     and other oral and non-insulin injected hypoglycemic agents and (2) the differences in~     utilization patterns between these agents will help with the design, analysis and~     interpretation of comparative effectiveness and safety studies of linagliptin, other DPP-4~     inhibitors, and other agents.~      The study will provide an overview of existing utilization patterns for linagliptin, other~     dipeptidyl peptidase-4 (DPP-4) inhibitors, other oral and non-insulin injected hypoglycemic~     agents, in order to detect potential selective prescribing patterns that might lead to~     channeling bias.~   "
109201|NCT02138084|"~     The purpose of this study is to provide dosing recommendations for the coadministration of~     BMS-663068 and Rifabutin with and without Ritonavir in upcoming Phase 3 studies and for~     prescribing information purposes~   "
109202|NCT02138071|"~     The purpose of the study is to determent whether there is a difference between two types of~     treatments in physiotherapy (individual vs group) for patients with low back pain (LBP), in~     terms of their sensation of how they have been helped and their treatments' outcomes~     measures. The study hypothesizes are: a) Based on the results of literature review which does~     not reveal a clear difference between group and individual treatments' outcomes for LBP, it~     is hypothesized that no difference will be found in treatment results for the two types of~     group treatments in the present study also, b) The assumption is that different distribution~     of therapeutic factors will be found in the two types of treatments (individual, group), C)~     Patients' sensation of how they have been helped will be connected to treatment results.~   "
109203|NCT02138058|"~     It is a double blind controlled study to test the hypothesis that Topiramate is more~     effective than placebo in the treatment of compulsive buying, during a period of 12 weeks~   "
109204|NCT02138045|"~     The purpose of this trial is to explore whether liraglutide has a long term effect on~     clinical symptoms and biomarkers in patients with diabetic neuropathy.~   "
109205|NCT02138032|"~     Message framing involves the presentation of choice alternatives, either in a positive or~     negative manner (Huber, Neale, & Northcraft, 1987; p.137). Positively framed health messages~     contain potential gains of participating/refraining in specific health behaviour.~     Alternatively, negatively framed health messages contain potential losses of~     participating/refraining in specific health behaviour (Verlhiac, Chappe, & Meyer, 2011). The~     primary aim and rationale of this study will be to investigate which type of framing has the~     greatest effect on intentions to quit smoking in patients with vascular arterial disease. The~     secondary aim is to investigate what other factors may have an effect on intention to quit~     and also what factors play a part in a patient's intention to quit smoking.~   "
109206|NCT02138019|"~     The fibrin sealants are prepared from fibrinogen, thrombin, and sometimes factor XIII that~     have been purified from human plasma. Tissucol Duo Quick (Baxter, Vienna, Austria) is a kind~     of fibrin sealants with popular use. It is a 2-component tissue adhesive that resembles~     natural fibrin formation. This glue has 2 components: fibrinogen (mixed with factor XIII and~     aprotinin) and thrombin-CaCl2 solution. When equal amounts of the 2 components are mixed, the~     monomers aggregate by cross-linking, resulting in a fibrin clot. It forms a elastic, whitish~     substance and provides strong adhesion to the tissue. Therefore, it is a good agent to seal~     small wounds or to replace the use of suture.~   "
109207|NCT02138006|"~     To investigate long-term effects on cardiovascular mortality/morbidity and renal failure in~     type 1 diabetes patients former randomized to intensive insulin treatment~   "
109208|NCT02137993|"~     The purpose of this study is to evaluate the efficacy and safety of A-prexa compared to~     Zyprexa in patients with schizophrenia, schizophreniform disorder and schizoaffective~     disorder.~   "
109209|NCT02137980|"~     This is a simple registry of patients undergoing PCI at hospitals without surgery on-site who~     were participants in the CPORT-E project. The aim of the registry is simple data collection~     and reporting to respective State Departments of Health. The registry population consists of~     patients undergoing diagnostic cardiac catheterization for suspected CAD at hospitals without~     SOS and who require PCI.~   "
109210|NCT02137967|"~     Formocresol (FC) is the most universally taught and most widely used pulpotomy medicament in~     the primary teeth. However, concerns have been raised over the use of FC because of its~     toxicity and potential carcinogenicity. A substitution for FC has been investigated but~     evidence is lacking to conclude which is the most appropriate technique for pulpotomies in~     primary teeth. Sodium hypochlorite (NaOCl) has been used in root canal irrigant for more than~     80 years, and it is at present the most popular irrigant in root canal treatment. Studies~     have showed that NaOCl is biological compatible and is a very good antimicrobial solution~     without being a pulpal irritant. Recent studies using sodium hypochlorite as pulpotomy~     medicament in primary molars showed promising results. In this project, the investigators~     propose a randomized clinical trial, which will be performed in Pediatric Dentistry~     Department of the National Taiwan University Hospital, to compare the treatment outcomes~     between NaOCl and FC in human primary molars needing pulpotomy treatment. The aim of this~     sudy is to determining weather NaOCl is a suitable replacement for FC in the pulpotomy of~     human primary molar teeth. To assess this aim, 200 healthy children from 2.5 to 9 year-old,~     who have at least one primary first or second molars diagnosed to receive pulpotomy treatment~     will be recruited in this project. The involved teeth will be randomly assigned to the~     control group (dilute 20% Formocresol (DFC)) or experimental group (2.5% NaOCl). At 3, 6, 9,~     12, 15, 18, 21 and 24 months post-treatment, the randomly assigned teeth will be clinically~     and radiographically evaluated by blinded independent evaluators to the treatment group. The~     differences will be statistically analyzed using chi-square test, Fisher exact test, and~     t-test, using a statistical significance at p<0.05.~   "
109211|NCT02137954|"~     This is a multicenter, prospective, randomized, placebo-controlled, double-blind,~     two-parallel groups study comparing lidocaine (experimental group) to placebo (control~     group). The study protocol was elaborated using the recommendations of the Consolidated~     Standards of Reporting Trials (CONSORT) Statement.~   "
109212|NCT02137941|"~     Chronic stress at work is a public health problem increasing morbidity and mortality,~     especially in men. Among the men military populations, the firefighters of Paris (FFPs) are~     particularly exposed. To deal with this stress and to improve stress management is~     challenging. Psychological fitness is required to regulate emotions which improve~     effectiveness under stress and enhance recovery from stressful events. The heart coherence~     (HC) program uses feedback from a simple pulse sensor to reflect changes of the~     emotional/psychological state, and to learn how to reduce stress and stabilize emotions.~     Another kind of psychological fitness focuses on cognitive training to regulate emotions,~     with the use of techniques to optimize potential (TOP). The TOP consists of learning easy~     techniques in mental skills to improve cognitive-based problem-solving using respiration,~     relaxation, and visualization. Although never published in a peer-review journal, the~     procedure of TOP training is structured and standardized for individuals and groups, and is~     widely practiced in air traffic controllers, with apparently good effects.~      Moreover, any event can be emotionally ambiguous, providing both negative and positive~     outcomes. The interpretation of such ambiguity is linked with an individual's emotional~     state, such as anxiety or mood. Individuals with a high level of trait anxiety are likely to~     interpret an event negatively.~      However, no studies have compared the effect of HC or TOP in the perceived stress of FFPs.~     Nor have long-term effects of these stress management programs (SMP) been investigated.~     Furthermore, the influence of trait anxiety on stress levels in FFPs needs to be clarified.~     Finally, no trials have assessed levels of biomarkers stress following these SMP.~      From these observations, we hypothesized that 1) young recruits aiming to become FFPs will be~     particularly exposed to stress, 2) SMP will be effective in reducing perceived stress, 3) SMP~     will mainly benefit FFPs who have high anxiety, and 4) the effects of SMP will lower levels~     of biomarkers of stress.~      The aim of this randomized control trial is to evaluate the effectiveness of stress~     management programs on perceived stress (primary outcome variable), and on negative mood,~     mindfulness, and biomarkers of stress (secondary outcome variables) in FFPs. We also aim to~     investigate the influence of anxiety on the stress management programs effectiveness~     long-term.~   "
109213|NCT02137928|"~     This study will evaluate the clinical efficacy of periocular injections of carboplatin~     together with chemotherapy in the treatment of Retinoblastoma as compared to chemotherapy~     alone.~   "
109214|NCT02137915|"~     This study is being done to determine the long-term safety and possible benefits of~     transplanted Human Central Nervous System Stem Cells (HuCNS-SC) for patients with Geographic~     Atrophy of Age-Related Macular Degeneration. This long-term follow-up study is limited to~     those individuals who received a transplant of HuCNS-SC cells into one of their eyes as part~     of the CL-N01-AMD study. No additional study product will be given in this 4-year long-term~     follow-up study.~   "
109280|NCT02137057|"~     Cardiac autonomic neuropathy is a common complication of diabetes and is associated with~     resting tachycardia. Regional anesthesia could interrupt normal autonomic activity by central~     sympathetic blockade. The investigators evaluate the relation of severity of diabetes and~     heart rate variability, also the impact of spinal anesthesia on the change of heart rate~     variability.~   "
109217|NCT02137876|"~     This study is being done to better understand how immunosuppressive medications~     (anti-rejection medications that may or may not be approved by the Food and Drug~     Administration (FDA)) affect the alloimmune response (how a person's immune system reacts~     against another person's immune system). This will be determined by the blood tests run on~     the patients donated blood cells.~      Specifically, the investigators will test different immunosuppression medications using~     in-vitro assays (in the laboratory, in test tubes) alone and/or in combination to test how~     they can affect B-cell proliferation and differentiation, leading to an altered distribution~     among defined B-cell subsets and to study if exposure of B cells to thymoglobulin can have~     effects on subsequent interaction between B and T cell in vitro.~      To enable the investigators to understand how immunosuppressant medications affect immune~     systems in transplant patients, the investigators need to understand how they affect immune~     systems in healthy people. To do this, the investigators will need to study blood collected~     from healthy volunteers.~   "
109218|NCT02137863|"~     The aim of this study was to evaluate the effects of dexmedetomidine on renal function,~     hormonal and hemodynamic parameters in contrast media induced diabetic patients.~   "
109219|NCT02137850|"~     This trial is conducted globally. The aim of the trial is to investigate the safety and~     efficacy of turoctocog alfa pegol (N8-GP) in previously untreated patients (PUPs) with~     haemophilia A.~   "
109220|NCT02137837|"~     This randomized Phase III trial studies how well the combination of fulvestrant and~     everolimus together or the combination of anastrozole, fulvestrant and everolimus together,~     improve progression-free survival (PFS) versus fulvestrant alone.~   "
109221|NCT02137824|"~     The aim of the present study is to establish a modified minimally invasive surgical technique~     for sinus floor augmentation with a residual bone height of 3-6mm.~      Hypothesis: The investigators expect that the present surgical technique allows to achieve an~     adequate implant bed of at least 10mm height after a healing period of 3-5 months. Further~     the modification of the technique enables a reduced patient stress level.~   "
109222|NCT02137811|"~     Recently an automated test for measuring cancer cell death in the presence of chemotherapy~     has been developed. This test has been called the MiCK assay during the ten year development~     phase and is now called Correct Chemo.~      CorrectChemo provides the medical community and patients a way to determine the effects of~     different chemotherapies on individual cancer cells.~      MiCK assay has been proven to have clinical usefulness in two studies. In one study using~     multiple types of cancer, physicians used the MiCK assay in 63% of the patients. If the~     physician used the results to prescribe the chemotherapy treatment, the patients' response~     rate, time to the disease getting worse, and overall survival were all significantly better~     compared to patients whose physicians did not use the results. In another study of breast~     cancer patients, physicians used the MiCK assay in 74% of patients. If the results were used~     when planning chemotherapy, response rate and time to the disease started getting worse were~     all significantly better compared to patients whose physicians did not use the results of the~     MiCK assay The purpose of this study is to compare the outcomes of patients who have had the~     MiCK assay (CorrectChemo) with tumor types, physician attitudes towards the test, and how the~     physicians used the test. This study will be gathering this data by reviewing medical charts.~   "
109223|NCT02137798|"~     To evaluate reduction of fluoroscopy time/dosis and safety of atrial fibrillation ablation in~     patients with paroxysmal atrial fibrillation using fluoroscopy image integrated 3-dimentional~     electroanatomical mapping system, comparing to using 3-dimentional electroanatomical mapping~     system without fluoroscopy image integration~   "
109224|NCT02137785|"~     The purpose of this study is to determine if Levulan Photodynamic Therapy (PDT) is safe and~     effective in the treatment of actinic keratoses on the upper arms and hands~   "
109225|NCT02137772|"~     The study evaluated the efficacy and safety of letermovir (MK-8228) for the prevention of~     clinically-significant CMV infection in adult, CMV-seropositive recipients of allogeneic~     hematopoietic stem cell transplant (HSCT). The hypothesis being tested was that MK-8228 is~     superior to placebo in the prevention of clinically-significant CMV infection through Week 24~     post-transplant.~   "
109226|NCT02137759|"~     In the first phase of this study (Cohort 1), the investigators will determine the feasibility~     of adding MRSI to the evaluation of newly-diagnosed GBM patients treated with standard RT/TMZ~     and determine whether magnetic resonance spectroscopic imaging (MRSI) can predict for better~     outcomes in these patients. In the second phase of this study (Cohorts 2a and 2b), the~     investigators will find the maximum tolerated dose of belinostat for treating newly-diagnosed~     GBM patients with standard RT/TMZ and will determine whether MRSI can aid clinicians in the~     early determination of response to this new therapy.~   "
109227|NCT02137746|"~     The purpose of this study is to assess the safety of the second cycle of DCVAC/PCa in~     patients who completed the first cycle of DCVAC/PCa in the clinical trial SP003 without an~     objective progression of the disease.~   "
109228|NCT02137733|"~     The purpose of this study is to investigate the non-inferiority of bisoprolol to carvedilol~     by evaluating tolerability (The probability that administered maintenance dose reaches the~     maximum will be determined as an indicator) as a primary endpoint when bisoprolol or~     carvedilol is administered for 48 weeks to Japanese chronic heart failure patients. In~     addition, the safety and efficacy of bisoprolol will be investigated.~   "
109229|NCT02137720|"~     The goal of this study is to evaluate the implementation and effectiveness of an intervention~     to improve diabetes self-management, emotional distress and metabolic control among adults~     with type 2 diabetes receiving care in primary care practices throughout New York City. The~     program will be implemented by the New York City Department of Health, through their Primary~     Care Improvement Project.~   "
109230|NCT02137707|"~     This study will determine whether in RRMS patients receiving Gilenya there is a link between~     disease progression and biologic markers.~   "
109281|NCT02137044|"~     The purpose of this study is to: (1) test the benefits of the patient-centered collaborative~     care treatment approach for persons with MS who also have depression and/or pain; and also~     (2) test whether this approach improves quality of life, patient satisfaction, adherence to~     other treatments, and quality of care in the MS care system.~   "
113044|NCT02087800|"~     This study aims to characterize the effect of smoking on stress-induced allopregnanolone~     (ALLO) response in women by menstrual phase. The investigators hypothesize that women who~     smoke will have a blunted ALLO response to stress.~   "
109231|NCT02137694|"~     Auto-takings by APU and vaginal APV during the consultations for FCU in the department of~     gynecology-obstetrics (Group 1) according to an instructions for use proposed to the~     inclusive women, with consent; the same proposal, APU and APV, is made for other~     consultations requiring a screening on the CHRU (Group 2: dermatology, endocrinology,~     ambulatory surgery, inner medicine, pneumology, oncology). Auto-takings transmitted in the~     laboratory of the CHRU of Brest for test HPV by quantitative real-time PCR. Results~     transmitted to the women and to the doctors of consultation. In case of positive test (15 %),~     the patients are directed to a gynecologist. Confrontation with the cytological data when~     available (Group 1) .~   "
109232|NCT02137681|"~     The project was undertaking by Qilu Hospital, Shandong University and other several~     well-known hospitals in China. In order to report the efficacy and safety of Rituximab in~     different frequencies for the treatment of adults with steroid-resistant/relapsed immune~     thrombocytopenia (ITP).~   "
109233|NCT02137668|"~     The purpose of this study is twofold. First, is to determine whether vancomycin is effective~     in the early treatment of Biliary Atresia (BA) and Primary Sclerosing Cholangitis (PSC), and~     if so, by what mechanism. Secondly, to characterize human intestinal microbial communities~     and their interactions with the host.~   "
109234|NCT02137655|"~     The development and implementation of fast-track principles in total knee and hip~     arthroplasty have resulted in early recovery and rehabilitation alongside a reduced length of~     hospital stay. This without a concomitant increase in morbidity or readmissions for medical~     or surgical complications and with reduced mortality. However, only little is known about~     function in the subacute period after arthroplasty, and there is a need for further data on~     physical and psychological functioning following discharge from hospital.This to ensure, that~     the positive results from the perioperative setting are carried forward in the subacute~     phase.~   "
109235|NCT02137642|"~     The purpose of this study is to evaluate safety and tolerability as well as the effects of~     RM-131 on colonic motor and sensory effects in patients with chronic constipation.~   "
109236|NCT02137629|"~     The main purpose of VIDAZA® DUE (Drug Use Examination) is to collect and evaluate the safety~     information of Korean MDS patients treated with VIDAZA®(SC or IV) according to the approved~     package insert, after approval of marketing authorization for new drug in Korea. In addition,~     the efficacy information of VIDAZA® in clinical practice is collected and evaluated. This DUE~     is a prospective, multi-centre, observational, non-interventional, post-marketing~     surveillance. At least 600 patients' data that is eligible for safety assessment will be~     collected.~      VIDAZA® DUE is to investigate frequency and change of Adverse Events(AEs)~      /Adverse Drug Reactions(ADRs), Serious Adverse Events(SAEs)/Serious Adverse Drug~     Reactions(SADRs), unexpected AE/ADR and unexpected SAE/SADR, and to scrutinize factors~     influencing safety & efficacy of the drug. It is necessary to examine patients' demographics~     and baseline characteristics, medical history, status of VIDAZA treatment, concomitant~     medication and evaluation of safety and final efficacy (best response) assessment.~   "
109237|NCT02137616|"~     This study assess the safety and effects of atypical antipsychotics in subjects with~     psychosis syndrome and psychosis risk syndrome.~   "
109238|NCT02137603|"~     The literature has reported that fast track surgery can be safely applied to children~     undergoing appendectomy for acute appendicitis. There is no current evidence regarding the~     application of same day discharge protocol in children with intra-operative findings of~     suppurative appendicitis. The current standard of care for patients who present with~     intra-operative findings of suppurative appendicitis includes post-operative admission and~     treatment with intravenous antibiotics. Patients are discharged home once they have met the~     following discharge criteria: temperature less than 38.5 degrees Celsius, pain control with~     oral pain medication, and tolerating a liquid diet. Given the evidence in the literature that~     has shown that same day discharge of patients with acute appendicitis is safe and effective,~     we propose that fast track surgery protocol can be safely applied to patients with~     intraoperative findings of suppurative appendicitis. We hypothesize that this will result in~     a decreased postoperative length of stay, without an increase in 30-day complication rate.~   "
109239|NCT02137590|"~     This study will investigate the effect of Spanish Black Radish on phase I and phase II enzyme~     activity in healthy adult males. The primary objective is to determine the effect on phase I~     and phase II enzyme activity by measuring plasma and urine acetaminophen metabolite~     concentrations prior to and after a 28 day supplementation period with Spanish black radish~     product.~   "
109240|NCT02137577|"~     The purpose of this study is to determine whether DEB is more effective than common PTA~     balloon using under in long-term vessel patency and inhibiting restenosis in the~     infrapopliteal artery.~   "
109241|NCT02137564|"~     This phase II trial studies the effects, good and bad, of gamma secretase inhibitor~     PF-03084014 and to see how well it works in treating patients with acquired immune deficiency~     virus (AIDS)-associated Kaposi sarcoma. Gamma secretase inhibitor PF-03084014 may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth and may shrink~     the tumor.~   "
109242|NCT02137551|"~     The primary objective of the study is to evaluate how engaging ACO beneficiaries in the~     appointment based model for one year impacts medication adherence and healthcare costs~     compared to usual care.~   "
109243|NCT02137538|"~     The purpose of the study is to determine if there are differences in the final height or~     hormone profile of short pubertal boys placed on different forms of aromatase inhibitor now~     routinely used to increase stature: Anastrozole and Letrozole. It also should determine if~     there are differences in the side effect profiles of the two drugs to be used.~   "
109244|NCT02137525|"~     This study will explore effectiveness of three doses of fentanyl sublingual spray against an~     active comparator in emergency department (ED) patients with acute pain.~      After screening, eligible participants will participate in a treatment period (up to 2 hours)~     and a post-treatment evaluation period (up to 4 hours or discharge from the ED). Open-label~     standard of care rescue medication for pain can be given at any time during the study period,~     based on clinical judgment of the treating physician.~      Adverse events will be collected for five days after initial enrollment.~   "
111887|NCT02102919|"~     The goal of this randomized controlled study was to examine the effects of a 8 weeks~     innovative training regime (stochastic resonance whole-body vibration [SR-WBV] and virtual~     virtual games [VG]) in the skilling up phase on physical performance and strength in elderly~     in need of care population.~   "
109245|NCT02137512|"~     The purpose of this study is to see if an automated insulin management system (study~     system) can safely be used at home to manage blood sugar. The study system includes (1) a~     CGM that measures glucose levels, (2) a computer program on a smartphone that determines how~     much insulin is needed and allows the study participant user to control the whole system, and~     (3) an insulin pump that delivers the insulin. The CGM will be from Dexcom. The pump will be~     from Roche. The CGM and pump are similar to the devices that are currently available for~     people to purchase and use. However, the smartphone device, the CGM sensor type used with it,~     and the overall study system can only be used for research at this time.~      The study will be completed by about 24 individuals at 6 centers in the United States and~     Europe. This study has several phases and will take about 11-14 weeks to complete depending~     on whether the study participant is a CGM user or not.~      At selected sites (based on subject eligibility and availability), approximately 10-20~     subjects who exhibit safe and competent use of the system at home will be given the option to~     continue home use of the system in Day-and-Night Closed-Loop mode for up to 5 months.~   "
109246|NCT02137499|"~     The investigators will be evaluating the immediate and longer term effect of treatment with a~     medical device on the symptoms of chronic venous disease.~   "
109247|NCT02137486|"~     Coronary artery bifurcation lesions prone to occur with the worsening of atherosclerosis.~     Their structural properties make angioplasty technique to increase the difficulty of~     implementation, but also increased the risks of the in-stent thrombosis and restenosis.~     Standard treatment of coronary bifurcation lesions remains controversial manner, especially~     when the side branch (SB) was large combined with high angulated bifurcation lesions. Complex~     procedures and certain types of lesions are associated with poor prognosis. There is no~     standard treatment for such lesions even with the development of drug-eluting stents solve~     partial problems. The investigators reviewed patients who received coronary intervention~     between 2009-2012 years and met the inclusion criteria, and then analyzed the prognostic~     relevance of these cases the use of different treatment modalities.~      We introduced a retrospective analysis for high angulated bifurcation lesions with~     intermediate to high complexity(SYNTAX>22) treated with either DES or BMS.~      Primary endpoint: cardiovascular mortality, TLR, MACE. secondary endpoint: procedure time,~     fluoroscopy time, procedure success, angiographic success.~   "
109248|NCT02137473|"~     Most very low birth weight infants accumulate a nutrient deficit in hospital due to minimal~     nutrient reserves and elevated nutritional requirements which may contribute to poor outcome.~     Adding nutrients to human milk improves their nutritional status and growth, but it is~     unclear if adding bovine protein-based fortifiers as is the current standard of care has some~     unintended negative consequences to neonates. Infants will be randomized to have their feeds~     (mother's own milk or pasteurized donor breastmilk) nutrient enriched with a human milk-based~     fortifier or a bovine protein-based fortifier and will be followed in hospital to assess~     feeding tolerance, growth, gut inflammation, gut microbiome, and neonatal morbidity and~     mortality.~   "
109249|NCT02137460|"~     This is a prospective cohort study for cognitively normal (young and old), mild cognitive~     impairment, and Alzheimer's disease people~   "
109250|NCT02137447|"~     The purpose of this study is to investigate the use of Negative Pressure Wound Therapy in~     high risk surgical wounds to evaluate the rate of surgical site infections (SSIs).~      Hypothesis:~      Historically, the average rates of infective complications in surgical wounds types are 7.7%~     in clean wounds, 15% for contaminated and 35-40% for dirty wounds. The application of Prevena~     ™ Incision Management System (Kinetic Concepts Inc, San Antonio, TX) is expected to reduce~     these rates by 50%.~   "
109251|NCT02137434|"~     The purpose of the study is to investigate calcium acute influence over the postprandial~     effects of a fatty meal on serum calcium, plasma glucose and triglycerides, blood pressure,~     oxidative stress, and endothelial function in obese women.~   "
109252|NCT02137421|"~     The aim of this study is to explore the role of Canonical β-catenin/Wnt and forkhead box O~     (FOXO) pathways by means of investigating their target genes in coronary artery disease (CAD)~     pathogenesis and to examine the effects of resveratrol (RES) on these pathways in CAD~     patients.~   "
109253|NCT02137408|"~     The Investigator would like to see if taking a DHA supplement at a dose recommended for heart~     health will improve brachial artery dilation (relaxation) and help blood pressure. As a~     second goal the Investigator would like to see if this supplement can delay preterm delivery~     by improving heart health. In this research study, the Investigator is asking pregnant women~     with chronic high blood pressure to take Expecta (DHA - Martek Biosciences, now known as DSM~     Nutritional Lipil) during the last half of their pregnancy until six weeks after they deliver~     their baby.~   "
109254|NCT02137395|"~     The purpose of this study is to determine whether dexamethasone extends the duration of~     recovery from anesthesia.~   "
109255|NCT02137382|"~     maldigestion of dietary macronutrients (pancreas not producing enough enzymes for digestion~     of fat, sugars and proteins) in Cystic Fibrosis~   "
109256|NCT02137369|"~     While there are many effective options for treating a major depressive episode, there are no~     clinical markers that predict the likelihood of remission with an initial trial of either an~     antidepressant medication or psychotherapy. The goal of this study is to test how brain~     function changes in depress patients treated with cognitive behavioral therapy (CBT) compared~     to patients treated with escitalopram ((s-CIT) - Lexapro®), an FDA approved antidepressant.~     The study aims to determine if bran scan findings might help physicians to select the most~     effective antidepressant treatment for an individual patient.~      At total of 150 male and female outpatients who are between 21-55 years old will be enrolled.~     Participation in the study will last from 14-26 weeks.~      Subjects will be randomized to receive either escitalopram (s-CIT) or CBT for 12 weeks.~     Resting-state positron emission tomography (PET) and BOLD functional magnetic resonance~     imaging (fMRI) scans will be done before the treatment begins, and again at the end of~     treatment (week 12). Non-responders to s-cIT or CBT will be crossed over to receive an~     additional 12 weeks of treatment with the alternative intervention.~   "
109599|NCT02132884|"~     This randomized clinical trial studies how well genetic sequencing-informed targeted therapy~     works in treating patients with stage IIIB-IV non-small cell lung cancer. Targeted therapy is~     a type of treatment that uses drugs or other substances to identify and attack specific types~     of tumor cells that may have less harm to normal cells. Genetic sequencing may help identify~     these specific types of tumor cells in patients with non-small cell lung cancer.~   "
109257|NCT02137356|"~     Locally advanced rectal cancer (T3, T4 or lymph node positive tumors) are conventionally~     treated with 5FU / capecitabine based chemoradiation prior to surgical resection. This~     treatment is associated with only a 15-20% pathological complete response. Selinexor~     (KPT-330) is a Selective Inhibitor of Nuclear Export (SINE) XPO1 antagonist that has~     demonstrated radiosensitization with in vivo models and has suggested single agent activity~     against colorectal cancers in a Phase I trial. Here we perform a Phase I/Ib trial of standard~     chemoradiation combined with Selinexor.~      We hypothesize that tumors treated with this new combination will demonstrate an increased~     response rate compared to those treated with capecitabine-radiation alone.~   "
109258|NCT02137343|"~     This is a Phase 3, multicenter, randomized, double-blind, placebo controlled study of~     Rilotumumab (AMG 102) with Cisplatin and Capecitabine (CX) for untreated advanced mesenchymal~     epithelial transition factor (MET)-positive gastric or gastroesophageal junction~     adenocarcinoma (GEJ).~   "
109259|NCT02137330|"~     The ongoing global rise in the prevalence of overweight and obesity among all ages and among~     all ethnic groups, figures into a real epidemic phenomenon. This is accompanied by a higher~     incidence in serious health risks, already present at an early age, switching-on the engine~     towards obesity-related co-morbid diseases and morbid obesity. Weight loss is the only way to~     avoid systemic and cardiovascular complications of obesity.~      Weight loss devices have been recently introduced in bariatric surgery, also in children.~     They mostly require invasive procedures to be applied. Mini-invasive devices would be needed~     to obtain weight loss in the pediatric population, since the early age of involved patients.~      Obalon intragastric balloons, are swallowable devices. They are filled with liquid or air,~     and have been used to induce weight loss in obese adults. The investigators aimed to perform~     a pilot study in pediatrics, and monitor weight loss, metabolic and cardiovascular parameters~     modifications, after up-to-3 Obalon® Gastric Balloons placement.~   "
109260|NCT02137317|"~     According to the World Health Organization pesticide poisoning is a major health problem due~     to the millions of cases annually occurring worldwide. Farmers have a particularly high risk~     of pesticide poisoning because of their work involving pesticide use to protect crops. The~     majority of pesticide poisonings occur in developing countries. On a short term it is not~     realistic to reduce farmers' use of pesticides significantly because it would require that~     secure and cost-effective alternatives are introduced. This is a lengthy process, which~     should undoubtedly be supported. However, it becomes as important to make sure that farmers~     can protect themselves from pesticide exposure meanwhile. Use of personal protective~     equipment can minimize pesticide exposure on farmers' bodies and consequently reduce their~     risk of pesticide poisoning. However, the sparse research identified through a systematic~     literature review shows that we are not in a position to give recommendations on what~     personal protective equipment farmers should protect themselves with against pesticide~     exposure suitable to their specific conditions. The purpose of the present study is to~     examine factors that influence farmers' use of personal protective equipment during their~     work with organophosphates and, based on this examine the ability of locally adapted personal~     protective equipment to reduce their organophosphate exposure. The hypothesis is that farmers~     working in locally adapted personal protective equipment have less acute organophosphate~     poisoning symptoms, a higher plasma cholinesterase level and find it to be a more feasible~     solution than farmers working in their daily practice wearing. Examining how locally adapted~     personal protective equipment (onwards referred to as the LAPPE solution) performs in~     practice implies testing it in an intervention study. A randomized crossover experiment~     design is chosen partly because fewer farmers have to be recruited since each farmer will act~     as his own control and partly because the between farmer variation is strongly reduced. The~     performance of the LAPPE solution will be tested in one experiment and compared to the~     performance of the same farmers' daily practice wearing (onwards referred to as the DP~     solution) in another experiment. The LAPPE solution is expected to have a superior~     performance. The participation sequence (LAPPE/DP or DP/LAPPE) will be randomized. The study~     will be conducted among farmers in Chitwan, Nepal.~   "
109261|NCT02137304|"~     The investigators want to demonstrate that there is an optimal expiratory pressure when using~     mecanical in-exsufflation for each patient in neuromuscular disease. This compromise is~     between the need to generate a high pressure difference between alveoli and the mouth and the~     need to avoide and superior airways collapsus.~   "
109262|NCT02137291|"~     Lung isolation is primordial in thoracic surgery. To achieve it, two techniques are used: the~     double lumen tube (DLT) and the bronchial blocker (BB). Left-sided DLT (L-DLT) is use by the~     majority of anesthesiologists for both left and right thoracic surgeries. Standard~     right-sided DLT (Rs-DLT) is rarely use since it is dif¬ficult to properly position it and~     that there is a risk of misalignment between the lateral orifice of the tube and the origin~     of the right upper lobe (RUL) bron¬chus. In 2007, the investigators have published results~     suggesting enlarging the Rs-DLT's lateral orifice. The modified R-DLT (Rm-DLT) was more~     frequently in an adequate position: 77% vs 37% of patients (p = 0.0121), and easier to~     reposition: 97% vs 74% of patients (p= 0.0109) in comparison to the standard R-DLT group. The~     data suggest the superiority of the Rm-DLT compared to Rs-DLT for optimal positioning to~     facilitate one-lung ventilation (OLV) during thoracic surgery. It is believed that DLT tend~     to provide quicker and better quality of lung collapse than BB. In 2013, investigators have~     demonstrated an equivalent quality of lung collapse (LC) between L-DLT and BB used with two~     apnea periods when initiating OLV. Complementary analysis showed a significative difference~     to obtain complete LC (CLC) between L-DLT for left thoracoscopy and L-DLT for right~     thoracoscopy and BB in right or left surgery. The investigator hypothesis is that, when using~     L-DLT for left video-assisted thoracoscopic surgery (VATS), LC of the isolated lung will be~     slower and of poorer quality compare to the use of the Rm-DLT. The primary objective is to~     compare the delay between pleural opening (PO) and CLC in left VATS when using three lung~     isolation devices: 1) L-DLT and 2) Rm-DLT. Secondary objectives are: 1) to evaluate quality~     of LC, 2) to evaluate the level of obstruction of the lumen of the left bronchus, 3) to~     evaluate the quality of OLV (PaO2) 4) To collect blind surgeon's opinion about de device used~     and 5) to measure the delay between OLV and PO for evaluating the role of absorption~     atelectasis in obtaining CLC. After obtaining IRB approval, the investigators propose a study~     of 40 patients undergoing an elective left VATS at IUCPQ involving one lung ventilation. They~     will have to be 21 years or more, to read, understand and sign an informed consent at their~     pre-operative evaluation. This study will be prospective, randomized, and blind to thoracic~     surgeons.~   "
109263|NCT02137278|"~     Investigate clinical effects (reduction of number of syncope and associate symptoms) of~     suspension of vasoactive drugs in patients affected by vasodepressor reflex syncope.~   "
109264|NCT02137265|"~     Hypothesis: Prescribed clomiphene citrate to azoospermic patients with hypoandrogenism could~     improve the sperm retrieval in either fresh sperm or after surgical sperm extraction.~   "
109265|NCT02137252|"~     Naltrexone is a drug which blocks some effects of chemicals called beta-endorphins that are~     made in the body. Beta-endorphins can be made in response to stress, injury, and also~     pleasurable activities. In previous studies, it has been shown that levels of beta-endorphins~     in the blood go up during radiation therapy, and that this increase is linked to fatigue.~     This suggests that naltrexone may help to reduce fatigue in people who are getting radiation~     therapy In this research study, the investigators are looking to see whether naltrexone works~     better than a placebo in reducing fatigue during radiation therapy.~   "
109266|NCT02137239|"~     Patients who undergo a kidney transplant require prolonged therapy with drugs that suppress~     the immune system (called immunosuppressive regimens) to stop the immune system from~     attacking the transplanted kidney in order to limit damage to or the possibility of rejecting~     the transplanted kidney. The purpose of this study is to evaluate benefits and risks of two~     immunosuppressive regimens (belatacept with everolimus or tacrolimus with mycophenolate~     mofetil) following thymoglobulin induction and rapid corticosteroid withdrawal.~   "
109267|NCT02137226|"~     Primary Objective:~      The primary objective of this trial is to establish an equivalence in efficacy between BI~     695501 and US-licensed Humira® in patients with active Rheumatoid arthritis based on a~     statistical comparison of the proportion of patients meeting American College of Rheumatology~     20% (ACR20) response rate at Week 12 and ACR20 response rate at Week 24 between BI 695501 and~     US-licensed Humira®.~      Secondary Objectives:~      The secondary objectives of this trial are to compare the efficacy, safety and immunogenicity~     of BI 695501 and US-licensed Humira® in patients with active RA including those undergoing~     the transition from US-licensed Humira® to BI 695501 after 24 weeks.~   "
109268|NCT02137213|"~     At least 30% of patients receiving methadone maintenance therapy (MMT) are suffering from~     constipation that often affects effectiveness of MMT and increases its impact on health care~     system. Existing treatments include several over-the-counter medications which do not target~     the pathobiological basis of opioid-induced constipation and have limited effectiveness. At~     the same time well-known medication, naloxone, was already shown to help with constipation in~     patients receiving methadone for chronic pain, but was never tried in patients receiving~     methadone for opioid dependence. This study is aimed to try naloxone for treatment of~     opioid-induced constipation in MMT settings.~      The investigators will enroll 20 patients receiving MMT and suffering from opioid-induced~     constipation. The study has a crossover design - all patients will receive one week of their~     regular methadone doses and one week of their regular methadone doses with naloxone added.~     Normal saline will be added to methadone-only formulations as placebo. Order of the weeks~     will be chosen randomly. Both subjects and investigators will be blinded to the study~     condition (i.e. whether naloxone or normal saline is added to methadone preparation on a~     given week).~      Primary hypothesis: Patients receiving combination of oral methadone/naloxone in ratio 50:1~     will have less severe symptoms of constipation compared to those receiving methadone only.~      Secondary hypothesis: Addition of oral naloxone to methadone in a ratio 50:1 will not cause~     clinically significant opioid withdrawal symptoms.~   "
109269|NCT02137200|"~     The investigators propose a large, multicenter, randomized clinical trial of immediate versus~     delayed pushing for nulliparous women in labor at term reaching complete cervical dilation.~     The central hypothesis is that immediate pushing in the second stage of labor increases~     spontaneous vaginal delivery, shortens duration of the second stage, and reduces adverse~     neonatal and maternal outcomes in nulliparous women. They will pursue the following specific~     aims: 1) Assess the effectiveness of immediate pushing at complete cervical dilation on the~     rate of spontaneous vaginal delivery in nulliparous women (Primary Aim), 2) Determine the~     effect of immediate pushing on the rate of neonatal composite morbidity (Secondary Aim #1),~     and 3) Determine the impact of immediate versus delayed pushing on objective and subjective~     measures of maternal pelvic floor morbidity (Secondary Aim #2). They estimate that~     randomizing a total of 3184 women will provide adequate statistical power to detect~     meaningful differences in the primary and secondary outcomes.~   "
109270|NCT02137187|"~     There is evidence of superiority of AV junction ablation strategy over pharmacological~     therapy only for symptoms of atrial fibrillation, but not for heart failure, hospitalization,~     morbidity and mortality. Hypothesis of trial is that AV junction ablation is superior to~     pharmacological therapy as regard hospitalization and mortality~   "
109271|NCT02137174|"~     Home and school visits by multidisciplinary team will improve metabolic control in kids~     having insulin dependent diabetes mellitus~   "
109272|NCT02137161|"~     OBJECTIVE To evaluate the efficacy of bromfenac ophthalmic solution 0.09% for reducing~     postoperative inflammation in eyes with pseudoexfoliation syndrome (PEX) undergoing cataract~     surgery and receiving standard postoperative eye drops (dexamethasone 0.1% plus tobramycin~     0.3% ophthalmic solution).~      DESIGN Two arms, parallel group, randomized, single center, prospective, phase IV clinical~     trial.~      PARTICIPANTS Sixty-two subjects with PEX and cataract will be sequentially assigned,~     according to a computer-generated randomization list (1:1), to bromfenac (n = 31) or not (n =~     31).~      INTERVENTION Cataract surgery by means of phacoemulsification and implantation of~     posterior-chamber intraocular lens will be performed by two experienced ophthalmic surgeons.~      Standard Arm: only a standard antibiotic and steroid ophthalmic suspension will be given~     starting the day after the surgery for two weeks, dosed QID for the first week and BID for~     the second week (dexamethasone 0.1% and tobramycin 0.3% eye drops association).~      Experimental Arm: eyes will receive bromfenac BID for two weeks starting the day after~     surgery. Standard post-operative topical antibiotic and steroid will be also given~     concurrently, dosed QID for the first week and BID for the second week (dexamethasone 0.1%~     and tobramycin 0.3% eye drops association).~      Measurements will be carried out at baseline and after one day, 3 days, 1 week and 4 weeks~     from cataract extraction.~   "
109273|NCT02137148|"~     The goals of this study are as follows; evaluation of the products' readiness to market,~     ascertain initial reactions by target users, evaluate actual use in potential clinical~     settings and any difficulties encountered with product use and actual venous cannulation.~   "
109274|NCT02137135|"~     Fluctuations of female sex hormones during the menstrual cycle influence pain perception.~     Endogenous pain is pronounced in the follicular phase of the menstrual cycle. The~     investigators tested the primary hypothesis that the women having surgery during their~     follicular phase have more acute pain and require more opioids than those in the luteal~     phase, and secondarily the investigators tested that women who have surgery during their~     follicular phase have more incisional pain at 3 month postoperatively.~   "
109275|NCT02137122|"~     This study will investigate whether transcranial direct current stimulation enhances the~     effects of cognitive training in healthy older adults.~   "
109276|NCT02137109|"~     The primary objective of the study is to evaluate the safety of natalizumab use in the~     pediatric multiple sclerosis (MS) population.~   "
109277|NCT02137096|"~     This is a pilot study to evaluate the response rates for patients undergoing high dose~     conditioning chemotherapy using Etoposide, Carboplatin and Ifosfamide followed by autologous~     stem cell transplantation for the treatment of recurrent Nasopharyngeal Cancer (NPC) in~     children, adolescents, and young adults.~   "
109278|NCT02137083|"~     Comparing Docetaxel Plus Fulvestrant With Docetaxel in Patients With Metastatic Breast Cancer~   "
109279|NCT02137070|"~     This study is being done to learn about the changes that weight loss causes on brain~     function, memory and thinking ability in adults. The study does NOT cover any costs~     associated with bariatric surgery.~   "
109282|NCT02137031|"~     The primary purpose of this pilot randomized controlled trial is to provide preliminary~     indicators of the effects of continuous subcutaneous insulin infusion with continuous glucose~     monitoring compared to self-monitoring of blood glucose alone on: (1) metabolic control and~     (2) fear of hypoglycemia. Additional objectives will be: (1) to provide an estimate of~     recruitment rates, (2) to assess compliance with allocated treatment, and (3) to determine~     participants' satisfaction with allocated treatment.~      With increased and immediate information related to current and future (trend) glucose~     information provided by the continuous glucose monitor, children can then act upon this~     knowledge to prevent hypo- or hyperglycemia, thus, experiencing a reduction in glucose~     variability, leading to an improvement in metabolic control as shown by a reduction in HbA1c~     levels.~      Research on the effectiveness of continuous glucose monitoring on metabolic control in~     children with T1D using continuous subcutaneous insulin infusion has been limited. Therefore,~     a pilot clinical trial will be designed to provide preliminary indicators of the feasibility~     and acceptability of continuous glucose monitoring on metabolic control and address the~     following objectives.~   "
109283|NCT02137018|"~     Nanotechnologies applied to General Surgery and Emergency Surgery: The Buckypaper as a new~     fixing method for prosthetic materials in the treatment of abdominal wall hernias,~     diaphragmatic hernias, diaphragmatic rupture, incisional hernia and abdominal wall disaster~     in laparotomy procedure and laparoscopic procedures. Experimentation on breed pig Lantrace~     ANIMAL MODEL.~   "
109284|NCT02137005|"~     The purpose of this study is to investigate longitudinally, the walking ability of~     individuals with cerebral palsy who are transitioning into adulthood and to cross-sectionally~     examine the health status of these individuals in the context of their walking ability. Young~     adults who received instrumented gait analysis (IGA) as children will show significant~     decreases in overall gait performance, as measured by kinematics, kinetics, temporal-spatial~     parameters, and gait deviation index, compared to their last childhood IGA.~   "
109285|NCT02136992|"~     Pirfenidone as anti-fibrosis drug developed in recent years demonstrated the potential anti-~     fibrotic effect, but so far there were no domestic studies about pirfenidone's efficacy and~     safety evaluation in china. The aim of this study was to evaluate the efficacy and safety of~     pirfenidone in patients with idiopathic pulmonary fibrosis (IPF) through the observation of a~     large sample of clinical cases.~   "
109286|NCT02136979|"~     CD39 and CD73 was known protein expressed on surface of Th1 and Th17 cell and modulate immune~     related reaction. Cardiopulmonary bypass (CPB) can induce inflammatory reaction during~     cardiac surgery, and induce immunosuppression. Propofol and volatile anesthetics were related~     to immune reaction. However, the effect of propofol and sevoflurane on the change of CD39 and~     CD73 after CPB was not evaluated in previous studies.~      The authors hypothesized that the expression of CD39 and CD73 would differ between propofol-~     and volatile anaesthetic-based anaesthesia in patients undergoing CPB. Therefore, the present~     study determined the effect of propofol and sevoflurane on CD39 and CD73 during and after~     CPB.~   "
109287|NCT02136966|"~     Study title: Joint Infant and young children nutrition program in Burkina Faso: Impact~     evaluation Hypothesis: The fortification of complementary foods associated with a counseling~     on feeding practices for infants and young children prevents malnutrition in 6-23 months-old~     children.~      Objective: to assess the effectiveness of a promotional care package in preventing~     malnutrition among children aged 6-23 months.~   "
109288|NCT02136953|"~     Obsessive compulsive disorder (OCD) is a severe and debilitating anxiety disorder afflicting~     2% of the population. Cognitive behavioural therapy (CBT) is considered first line~     psychological treatment for OCD, but there are a large number of treatment non-responders,~     and the majority of responders have residual symptoms. Aerobic exercise has shown potential~     benefit for general mood and anxiety disorders, but has not been widely tested in OCD. This~     study will examine the additive benefits of a standard 12-week aerobic exercise program to a~     standard 12-week CBT protocol in the treatment of OCD. The study will test if Exercise+CBT~     results in significantly better clinical outcomes compared to either treatment alone or no~     treatment at all. Treatment outcomes will be assessed in relation to symptom and cognitive~     measures of clinical improvement.~   "
109289|NCT02136940|"~     The objective of this parallel group study is to evaluate the safety, tolerability and~     efficacy of AMA0076 in reduction of intraocular pressure in subjects with primary open-angle~     glaucoma or ocular hypertension.~   "
109290|NCT02136927|"~     Pharmacokinetic, bioequivalence study~   "
109291|NCT02136914|"~     This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group~     study to evaluate the efficacy and safety of ADS-5102 extended release (ER) capsules, an~     investigational formulation of amantadine, dosed once nightly at bedtime for the treatment of~     levodopa induced dyskinesia (LID) in subjects with Parkinson's disease (PD). The novel~     pharmacokinetic profile of ADS-5102 is expected to achieve i) maximal concentrations in the~     early morning through mid-day, when LID can be troublesome, and ii) lower concentrations in~     the evening, potentially reducing the negative impact of amantadine on sleep. This~     pharmacokinetic profile could enable higher doses to be tolerated with a once-nightly ER~     formulation than can be tolerated with an immediate-release formulation. The once-nightly~     dosing regimen may also provide enhanced convenience and compliance.~      In a previous clinical study, ADS-5102 met its primary endpoint; LID was significantly~     reduced as measured by the change in UDysRS score over 8 weeks vs. placebo.~   "
109292|NCT02136901|"~     The NUsurface® Meniscus Implant Randomized Study is a multi-center, prospective randomized,~     interventional clinical trial to test the hypothesis that the NUsurface implant is superior~     to the non-surgical standard of care in treating the target population.The rationale for~     performing this clinical study is to gather clinical data to evaluate the safety and~     effectiveness of the NUsurface device compared to the Standard of Care.~   "
109293|NCT02136888|"~     The aim of this study is to demonstrate that therapeutic and supratherapeutic plasma~     exposures to ponesimod do not have an effect on cardiac repolarization exceeding the~     threshold of regulatory concern as measured by the QTc (interval from beginning of the Q wave~     until end of the T wave corrected for heart rate) interval duration after administration of~     multiple oral doses of 40 mg and 100 mg to healthy male and female subjects.~   "
111908|NCT02102646|"~     The purpose of this study is to investigate if androgen deprivation therapy in men with~     prostate cancer increases hepatic fat content and changes visceral/subcutaneous fat~     distribution.~   "
109294|NCT02136875|"~     The purpose of this pilot study is to determine whether early treatment of acute~     exacerbations of chronic obstructive pulmonary disease (AECOPD) with a combination therapy,~     Salmeterol + Fluticasone Propionate (SFP - Advair) will reduce the use of prednisone, known~     as the conventional treatment.~      Primary objective: To determine whether early treatment with combination therapy (SFP) can~     reduce the use of prednisone (the conventional treatment) in the event of an AECOPD.~      Secondary objectives:~        -  To evaluate the feasibility of this treatment approach and to provide pilot data (needed~          for a larger multi-centre clinical trial;~        -  To evaluate the feasibility and need of assessment during and after exacerbation onset,~          health-related quality of life and physical activity;~        -  To evaluate the safety of this approach; this is in terms of the delay in starting~          prednisone and an unfavourable outcome (ER visits and/or hospitalization).~   "
109295|NCT02136862|"~     There is limited published clinical data about the natural history of renal disease in Alport~     syndrome. The RG012-01 study will collect data to characterize the progression of renal~     dysfunction in Alport syndrome patients.~      Patients with a confirmed diagnosis of Alport syndrome who have qualifying GFR will be~     considered for enrollment. The sequential sampling of subjects' urine and/or blood will allow~     an assessment of the rate of change of established clinical endpoints, such as GFR and/or the~     rate of change of other renal biomarkers (proteinuria and β-2 microglobulin) in subjects~     whose renal function is steadily declining. The identification of surrogate markers that~     track the decline of renal function and could correlate with time to end-stage renal disease~     (ESRD) is a key goal of the natural history study.~   "
109296|NCT02136849|"~     Intellectual disability (ID) moderate or severe affects about one child in 250, with 3000 to~     4000 new cases each year. Chromosomal or molecular pathology causes are not identified in~     half of the cases by current techniques. Studies show that de novo mutations are common in~     many different genes. The exome approach by high-throughput sequencing (NGS) has emerged as~     the technique of choice for identifying and comparing the exome of the child to the parent.~     We wish to evaluate this approach and its contribution in the diagnostic management of 50~     patients with DI seen in genetics in 6 CHU Great West. Genomics platform IBISA / Biogenouest~     will provide technological and bioinformatics support this project.~   "
109297|NCT02136836|"~     The objective of this study is to investigate the proportion of HER2 overexpression in~     gastric cancer patients group, to evaluate the relation of HER2 overexpression with~     prognosis, and to analyze the proportion of herceptin applied to patients in clinical field.~     Furthermore, the investigators are going to reevaluate the clinical benefit of Herceptin for~     survival prolongation compared to chemotherapy only.~   "
109298|NCT02136823|"~     This study is being done to measure the differences between the electrical activity of~     muscles and /single muscle fibers in individuals with long-term spinal cord injury and~     neurologically intact individuals without spinal cord injury. This study is also being done~     to find out if muscle and /single muscle fiber electrical activity, voluntary strength,~     reflex measurements, and/or spasms are changed after a single, oral dose of three commonly~     prescribed drugs, Rilutek®, isradipine, and Namenda®. These medications are approved by the~     FDA for treatment of disorders other than the control of spasms and strength. In this study,~     they are being used in an experimental manner. Finally, this study is also being done to find~     out whether or not a brief stretching exercise influences reflex measurements.~      The main hypothesis of this study is that aberrant current activity in spinal motoneurons~     contributes to spastic hyper-reflexia following chronic spinal cord injury.~   "
109299|NCT02136810|"~     This study aims to assess the performance of presurgical clinic blood pressure measurements~     in predicting home blood pressure readings among surgical patients. It also aims to measure~     the association between home blood pressures and patient perspectives on blood pressure~     control.~   "
109300|NCT02136797|"~     The purpose of this study is to see how well transfusions of T-cells work in treating CMV.~     Tcells are a type of white blood cell that helps protect the body from infection. A~     transfusion is the process by which blood from one person is transferred to the blood of~     another. In this case, the T-cells are made from the blood of donors who are immune to CMV.~     The T-cells are then grown and taught to attack the CMV virus in a lab.~   "
109301|NCT02136784|"~     The aim of this study is to examine the effects of opioid analgesics on acute pain in~     participants maintained on buprenorphine+naloxone (Suboxone) for opioid use disorders. Seven~     medication conditions will be tested in a cold pressor test (CPT) paradigm.~   "
109302|NCT02136771|"~     In this randomized, double-blind, placebo-controlled trial we plan to enrol 200 vitamin D~     deficient hypertensive patients. Our main objective is to evaluate whether vitamin D3~     supplementation with 2,800 IU daily for 8 weeks has an effect on 24-hour systolic ambulatory~     blood pressure (ABP) compared to placebo. In addition, we also aim to evaluate whether~     vitamin D3 supplementation alters 24-hour diastolic ABP, pulse wave velocity,~     N-terminal-pro-brain natriuretic peptide (NT-pro-BNP), corrected QT interval (Bazett~     formula), renin, aldosterone, 24-hour urinary albumin excretion, HOMA-IR (HOmeostatic Model~     Assessment: Insulin Resistance), triglycerides and HDL-cholesterol.~   "
109303|NCT02136758|"~     This study was a prospective, randomized trial designed to investigate the efficacy of~     moderate lifestyle modification for improving the clinical status of patients with coronary~     artery disease or patients with risk factors that promote coronary artery disease.~   "
109304|NCT02136745|"~     In this pilot study, the investigators examined whether a relaxation response mind-body~     intervention could be effectively delivered to mixed groups of IBS and IBD patients and~     determined the effects of the intervention on quality of life, inflammatory markers, and gene~     expression using transcriptional profiling.~   "
109349|NCT02136160|"~     Population based intervention at elementary school setting aimed at contributing, to a major~     extent, to health education and health promotion for children aged approximately 5-10 years~     in Germany. Health education units with theoretical and practical exercises for use by~     teachers, children, and parents addresses physical activity, sedentary behavior, relaxation,~     nutrition, personal hygiene and body awareness.~      Main questions of the pilot are:~      Does health promotion take on an important role in primary schools? How do teachers evaluate~     training materials, homepage, content and framework conditions? How do teachers assess the~     efficiency of teaching units?~   "
109305|NCT02136732|"~     With a growing aging population, the number of persons with chronic conditions continues to~     escalate and challenges related to chronic care quality, effectiveness and cost remain~     unresolved.Federally Qualified Health Centers (FQHC) have experienced increasing numbers of~     patient visits for chronic conditions, and FQHC patients are more likely to have serious~     chronic conditions when compared to patients being cared for by non-FQHC providers.~      The Chronic Care Intervention (CCI) combines home visiting with health activation coaching~     and has resulted in improved health status and reduced expenditures (Preliminary Studies).~     Implementing the CCI for aging adults with multimorbidity (2 or more chronic conditions) and~     high baseline acute care utilization, allows us to test and expand the efficacy, external~     validity and cost effectiveness of the proposed intervention model. The investigators seek to~     improve patients' and FQHCs' abilities to effectively manage chronic conditions and reduce~     acute care use. This contribution is significant because it potentially extends our knowledge~     about effective community partnerships and best practices that can enhance the effectiveness~     of health homes in providing patient-centered team-based care for patients with~     multimorbidity and high baseline health care utilization.~   "
109306|NCT02136719|"~     the investigators aim to compare bimanual uterine compression immediately after delivery of~     the placenta for 5 minutes versus no intervention for the prevention of postpartum hemorrhage~     in Women at high risk for primary atonic postpartum hemorrhage. The primary outcome is~     postpartum haemorrhage (blood loss of ≥ 500 ml) while the Secondary outcomes include use of~     additional uterotonics and need for blood transfusion.~   "
109307|NCT02136706|"~     Encouraged by the recent data published ,the investigators think that a waiting time of 10~     minutes is feasible while preserving diagnostic accuracy and would like to assess the~     feasibility and diagnostic efficacy of W10 compared with W30 imaging in a pilot study. By~     combining W10 imaging with half-time acquisition, the time of the technetium-99m myocardial~     perfusion imaging procedure could be shortened by at least 50%, lasting only 40 minutes for~     W10 (10-minute waiting) imaging compared with 90 minutes for W30 imaging (30-minute waiting).~      The investigators hypothesize that (1) W10 MPI is clinically feasible and tolerable by the~     patients, that (2) W10 MPI provides high image quality and that (3) W10 MPI provides~     diagnostic accuracy comparable to W30 MPI.~   "
109308|NCT02136693|"~     This study aims to assess whether fiber intake, formerly recommended only before or instead~     of surgery, may play a role in improving postoperative progress and functional outcome after~     STARR for obstructed defecation, in terms of residual constipation, incontinence and~     defecation urgency.~   "
109309|NCT02136680|"~     This is an investigator-initiated study to measure the impact of an educational intervention~     of the basic palliative approach for a multidisciplinary staff team of an outpatient HIV~     clinic early in disease trajectory. The study aims to 1) refine a curriculum for~     non-palliative clinicians caring for persons living with HIV disease early in disease~     trajectory; 2) assess the impact of this palliative educational intervention on outcomes for~     2 target populations: a) staff (burn-out and caregiving stress) and b) patients (retention in~     care, mental health, and quality of life). It is hypothesized that training outpatient HIV~     staff in palliative competencies will improve care provided that might, in turn, improve~     clinical outcomes for one group of HIV patients receiving care from the clinic. Quantitative~     data will be augmented by qualitative interviews of selected staff and patients in the final~     year of the study to appreciate response to the intervention.~   "
109310|NCT02136667|"~     In order to assess circulating biomarkers of cardiovascular risk, we will conduct a 10-year~     follow-up study comparing 32 exposed (women with a history of pregnancy complicated by~     preeclampsia) and 32 unexposed (women with a history of uncomplicated pregnancy).~      Participants will be recruited from a well-characterised cohort, previously assembled during~     their pregnancies, at the Department of Obstetrics at Randers Regional Hospital in 2001-2004.~      Blood and urine samples, collected during their pregnancies, are stored in a biobank, thus~     rendering the possibility of longitudinal assessment.~   "
109311|NCT02136654|"~     South Asians (SA) living in Canada and globally have high rates of type 2 diabetes~     (diabetes). Despite the burden of diabetes in this population, diabetes management remains~     poor. SA patients are less likely to exercise, follow a healthy diet (4), participate in~     exercise programs (5), and are 24% less likely to achieve glucose, blood pressure and lipid~     targets for diabetes than the general population (6). 55-60% of SA patients were non-adherent~     to their diabetes life-saving medications, compared to 30-35% non-adherence in the general~     population (7). This large gap in diabetes care is not surprising given language and~     communication barriers between primary care providers and SA patients (8-10), lack of~     knowledge about diabetes (8-11), preference for alternative therapies (12-14) and~     fundamentally different cultural beliefs on diabetes and diabetes management (15-18).~     Although there is some preliminary evidence that culturally tailored, chronic disease models~     may improve outcomes (21-24), the current evidence base is insufficient to justify the system~     modifications required to provide culturally tailored care across primary care settings in~     Canada. We propose to conduct a randomized controlled trial to assess the impact of a novel~     culturally tailored lifestyle and medication adherence intervention in SA patients with~     poorly controlled diabetes. The study is called the Novel Model for South Asian diabetes~     Treatment (NaMaSTe-Diabetes) trial in primary care.~   "
109312|NCT02136641|"~     Objective: To determine the efficacy of sedation schemes to sedation in patients about to~     undergo spinal anesthesia.~      Methods: Pilot study, clinical type, randomized, prospective, single-blind, in which the~     investigators compared three schemes for sedation in patients undergoing spinal anesthesia.~      Keywords: Anesthesia, Spinal Anesthesia, Conscious Sedation, Operating Rooms.~   "
109376|NCT02135809|"~     The purpose of this study is to document the performance of a new Fully Covered Self~     Expanding Metal Stents (FCSEMS) for treatment of refractory pancreatic duct strictures in~     patients with painful chronic pancreatitis.~   "
109455|NCT02134769|"~     Bionecteur® is a protective non-touch applicator to ensure aseptic connection made by Vygon.~     However, there are no studies describing a positive effect of using Bionecteurs ® in regard~     to catheter-related bloodstream infections. In this study Bionecteur® will be used on central~     venous lines and arterial lines in postoperative patients of a 40-bed ICU. The incidence of~     catheter-related bloodstream infections will we compared to patients without inclusion of~     Bionecteur® devices.~   "
109313|NCT02136628|"~     The posincisional hernia is considered a delicate complication , with an incidence of 10-12%~     in patients undergoing laparotomy may reach 45% in case of emergency and high-risk patients .~     It is estimated that in the United States are made about a million of reoperations for~     correction of this complication , with millions and despite the myriad studies that have been~     done in recent years there has been a decrease in the incidence losses and mortality of this~     complication.~      Given the seriousness of this problem the last global consensus guidelines sent to the~     surgical community in three main areas: Identify the importance of the problem, improve the~     theoretical knowledge and technical capacity in the closure of the abdominal wall and~     Implement prophylaxis in selected patients.~      The technique of reinforced tension line (RTL) was proposed by hollinsky and collaborators~     and is a strengthening of the abdominal incision with placement of a suture that runs lateral~     to the edge of the incision and closure of the abdominal wall is performed the usual manner~     with the only surgete continuous suture for closure is placed lateral to the suture~     reinforcement.~      In the present study may contribute to these guidelines and to groups of patients at high~     risk were identified and applying the RTL technique and demonstrate that its use is safe and~     useful in reducing the presence of this complication could be implemented as prophylaxis~     handling the same .~      The RTL method was applied experimentally on bodies to close the abdominal wall also be used~     in a cohort of patients for hernia repair wall , showing that by using it the abdominal wall~     is more resistant to shear forces by theoretical foundation that exists to show that could~     prevent the development of incisional hernias. There are no studies in the literature~     comparing this technique against conventional methods of closure of the abdominal wall as to~     the prevention of the same.~   "
109314|NCT02136615|"~     In a recent series of studies performed by our group, we have shown that exposure to~     hyperbaric oxygen (HBOT) leads to an increase in insulin sensitivity in male subjects and~     that this improvement can be measured in all men, not just those with diabetes. The aim of~     this study is to investigate the time course of this effect and explore the mechanisms~     involved when exposure to HBOT induces an increase in peripheral insulin sensitivity.~      Aims:~        1. To determine whether the insulin sensitising effect of HBOT is apparent 24-hours after~          an HBO session.~        2. To examine mechanisms underpinning the increase in insulin sensitivity following HBOT.~   "
109315|NCT02136602|"~     Good glycemic control is superior to poor glycemic control in reducing risk of~     interventricular septal thickness among fetuses of diabetic mothers.~   "
109316|NCT02136589|"~     PG-analogues induce hyperemia as one of side effects in addition to IOP reduction.~      IOP reduction is caused by direct FP receptor stimulation, but the cause of hyperemia is not~     clarified.~      Because FP receptor stimulation induce intrinsic production of PGs, hyperemia or IOP~     reduction may be due to secondary induced PGs.~      Thus, pretreatment with NSAID may affect the PG-analogue induced hyperemia or IOP reduction.~   "
109317|NCT02136576|"~     The aim of this pilot research project is to compare the clinical effect on dentinal~     hypersensitivity of three products: Casein Phosphopeptide-Amorphous Calcium Phosphate~     (CPP-ACP) paste with fluoride, 5000 Sodium Fluoride (NaF) dentifrice containing Tri-Calcium~     Phosphate (TCP), and a dentifrice containing Potassium Nitrate.~      The hypothesis of this study is that CPP-ACP with fluoride and 5000ppm NaF with TCP will~     exhibit a greater reduction in dentinal hypersensitivity compared to the control (dentifrice~     containing Potassium Nitrate).~      The results of this pilot study will validate or negate the need for a larger clinical study~     that may provide generalizable results for using caries-prevention products with the~     additional benefit of minimizing dentinal hypersensitivity.~   "
109318|NCT02136563|"~     This is an observational clinical research on patients with chronic kidney disease who are~     not on hemodialysis and receiving darbepoetin alfa to treat diagnosed renal anemia; the major~     objective is to explore novel erythropoiesis stimulating agent (ESA) response index in~     association with deterioration of renal function as well as occurrence of cardiovascular~     disease events.~   "
109319|NCT02136550|"~     Smoking cessation improves health conditions with reduction of the risk factors for~     cardiovascular and respiratory disease, as functional capacity and quality of life. Smoking~     cessation has positive effects on the miRNAs regulation, however, genomics has been little~     explored. Smoking and aging induces changes miRNAs. Among the changes in airway epithelial~     cells, miR-125 called attention because it is enrolled in the suppression of ERBB7 (tirosin~     kinase receptors), a codified sequence of the growth factor receptor (EGFR) frequently~     expressed in cancer. The reduction of miR-125 expression may reduce cancer suppression~     resulting in cancer development. Other miRNA changes can be observed, such as miR-218 that~     were found in smokers airway epithelial cells as in MiR-15b that were found in lung tissue of~     COPD smokers. These miRNAs participated in the signalling pathway of TGF-β enrolled in~     leukocyte migration and cell proliferation. The investigators hypothesize that smoking~     cessation has a role in the regulation or reduction in the genetic changes smoking-induced.~     The investigators will assess the subject genomic profile at the baseline, 6 months and 12~     months after smoking cessation.~   "
109320|NCT02136537|"~     The investigators wish to investigate the effects of neuromuscular stimulation on~     intermittent claudication.~   "
109321|NCT02136524|"~     This study will be a Phase 1, open-label, randomized, 2-period, 2-treatment sequence~     crossover study to determine the relative bioavailability of cobimetinib administered as a~     single dose of the tablet formulation relative to a single dose of the capsule formulation to~     healthy male and female participants. A minimum of 24 participants (12 participants per~     sequence) will complete the study. Participants will be randomly assigned to 2 possible~     sequences (i.e., I: A/B, II: B/A) where the treatments are as follows: Treatment A: One~     cobimetinib tablet administered as a single oral dose after at least an 8-hour fast;~     Treatment B: Four cobimetinib capsules administered as a single oral dose after at least an~     8-hour fast. The study is expected to last approximately 7 weeks.~   "
109322|NCT02136511|"~     This study is to provide idelalisib (IDELA) to individuals with relapsed, previously treated~     chronic lymphocytic leukemia (CLL) who have limited treatment options and are not eligible~     for other Gilead-sponsored studies.~   "
109323|NCT02136498|"~     The purpose of this pilot study is to evaluate the acceptability and feasibility of the~     proposed smoking cessation intervention (called MyMAP or My Mobile Advice Program).~   "
109396|NCT02135549|"~     To assess the safety and effectiveness of two doses of SugarDown in two different doses vs.~     placebo on serum glucose levels after meals in subjects with Type 2 Diabetes treated with~     metformin alone. There will be five visits, a screening visit, baseline visit, and 3~     treatment visits. The study duration will be five weeks. Subjects will all receive placebo~     tablets at the baseline visit, eat a standard rice meal, and then serum glucose levels will~     be measured in frequent intervals over four hours immediately following the meal. Subjects~     will be randomized to one of the six treatment sequences. Patients will take in an unknown~     order one week of placebo, one week of 4 g dose and one week of 8 g dose of SugarDown~     immediately before breakfast, lunch and dinner meals. Patients will continue their usual~     metformin regimen during the trial period.~   "
109324|NCT02136485|"~     This application concerns a proposed randomised controlled trial evaluating the use of~     Mindfulness-based stress reduction (MBSR) in people with Multiple Sclerosis (MS) in secondary~     care.~      MS is an inherently stressful condition, and stress is thought to exacerbate MS. Mental~     health problems are common in MS, can impair quality of life, and lead to higher rates of~     suicide.~      Prior research has shown that cognitive behavioural therapy (CBT) can help mitigate stress~     and diminish disease activity in MS, but effects are short-lived and there is thus a need to~     explore whether other psychological approaches might be more beneficial in this regard.~      MBSR is another psychological stress reduction technique that is thought to operate~     differently to CBT, via cultivating a state of meta-cognitive awareness and has shown to be~     helpful when used in other long term conditions, such as chronic pain and anxiety, whilst~     Mindfulness-based cognitive therapy (MBCT - a derivative of MBSR) is effective in treating~     recurrent depression. All of these conditions are common in MS. However, mindfulness based~     interventions have not been well studied in MS.~      The investigators propose to carry out a feasibility study to assess how acceptable and~     accessible MBSR is as a stress reduction technique in people with MS. The investigators would~     seek up to 50 participants who would then be randomly assigned to receive MBSR or their usual~     care. The investigators would seek measurements of health and wellbeing before, immediately~     following, and 3 months following the MBSR intervention. This would include basic demographic~     information (age, gender, ethnicity), measures of mental health, and physical health, as well~     as qualitative semi-structured interviews with selected participants. After this we would~     offer MBSR to the control group.~   "
109325|NCT02136472|"~     Introduction:~      Overall, 10 - 15% of couples seek specialist help once in their lives when a spontaneous~     pregnancy does not occur. These couples are defined subfertile when there is at least one~     year of unprotected intercourse without conceiving. Subfertility can have different causes~     which can be diagnosed with a basic fertility work-up. Unfortunately, the subfertility in 25%~     of the couples still remains unexplained.~      Hypothesis:~      The investigators hypothesize that cardio-metabolic and hemodynamic abnormalities reducing~     cardiovascular reserves relate to circulatory redistribution at the expense of uterine~     perfusion and with it women's fertility. This could especially be important in the subgroups~     with an unexplained subfertility and a decreased ovarian reserve. Interventions to improve~     these abnormalities could lead to better results in fertility treatment, better obstetric~     outcome and reduced lifelong health risks.~      Objective:~      The investigators want to examine specific cardio-metabolic and cardiovascular parameters in~     women of subfertile couples. The investigators want to evaluate the prevalence of metabolic~     syndrome in all women who are assessed for subfertility compared to healthy parous women.~     Furthermore in the women with an unexplained subfertility or with (signs of) a decreased~     ovarian reserve the cardiovascular profile will be studied consisting of the uterine artery~     pulsatility index (PI) as measure of uterine perfusion, the plasma volume as measure of~     venous reserve capacity, the intima media thickness of the carotid arteries as proxy of~     chronic strain and the endothelial function, measured by flow mediated dilatation (FMD) of~     the brachial artery.~      Study design:~      Cross-sectional~      Study population:~      The study group consists of subfertile women between 18 and 41 years who visit the fertility~     clinic in the Maastricht University Medical Centre with a primary or secondary subfertility.~     Women with an unexplained subfertility or with (signs of) a decreased ovarian reserve are~     evaluated for their cardiovascular profile. The control group consists of women with a~     history of an uneventful spontaneous pregnancy.~      Main study parameters:~        1. Prevalence of metabolic syndrome in subfertile women~        2. The cardiovascular profile, in women with an unexplained subfertility or with (signs of)~          a decreased ovarian reserve, consisting of:~             -  The uterine artery pulsatility index~             -  The plasma volume~             -  The intima media thickness (IMT)~             -  The endothelial function of the vascular system (FMD)~   "
109326|NCT02136459|"~     The purpose of this study is to test the investigators hypothesis that intubation with a~     smaller ETT would lead to reduced postoperative vocal impairment and laryngoscopic evidence~     of laryngeal trauma than intubation with a standard size ETT.~   "
109327|NCT02136446|"~     Patients scheduled for mastectomy and suitable for paravertebral block will be randomized to~     one of 2 groups.~      Group 1 will have the nerve block performed using a standard non-echogenic needle and~     catheter under ultrasound guidance. Group 2 will have the block performed using the control~     needle and an echogenic catheter, all under ultrasound (US) guidance.~      The clinician will be blinded to the catheter type and will assess the quality of catheter~     visualisation of the US image during the procedure, along with adequacy of spread of local~     anesthetic. The primary outcome will be needle visibility, and secondary outcomes will be~     block success rate and block quality. An assessment of the patient's pain levels after the~     procedure will also be conducted.~   "
109328|NCT02136433|"~     The purpose of the study is to test the effectiveness of training using novel tablet~     applications for hand function, compared to traditional hand exercises. In addition, we aim~     to examine brain plasticity following treatment with the new tablet applications. We~     hypothesize that training with a tablet would prove to be more effective than traditional~     exercises. We expect to observe neuroplastic changes in the brain in patients who practiced~     finger movements using the tablet.~   "
109329|NCT02136420|"~     The investigators will study adaptation of motion perception and manual control in altered~     gravity, including the effects of a drug (promethazine). The investigators will also study~     whether promethazine affects motion perceptual thresholds.~   "
109330|NCT02136407|"~     The purpose of this study was to study seasonal inter-individual and intra-individual~     variations in S-25(OH)D and to explore parameters associated with S-25-OHD in healthy Swedish~     adults.~   "
109331|NCT02136394|"~     Scarring of the lungs is common in patients with scleroderma and is one of the main causes of~     death. Patients with scleroderma very frequently have problems with their gullet (esophagus),~     the food pipe that leads into the stomach.~      Normally, a small circular muscle at the base of the esophagus opens to allow food to pass~     into the stomach and closes to keep the digestive fluids from flowing back up into the~     gullet. In patients with scleroderma, the muscle may become weak and no longer close~     properly. Gastroesophageal reflux (GER) is the medical term for reflux of stomach contents~     into the esophagus.~      Our hypothesis is that small amounts of GER can move back up into the esophagus and get~     inhaled into the lungs, and may be one of the triggers for lung scarring. We propose to look~     for certain substances normally only found in the stomach in the exhaled breath condensate~     which is collected by breathing comfortably into a cooled cylinder, allowing the breath to~     condensate. In a smaller group of patients, we also plan to perform a bronchoalveolar lavage,~     a more widely studied test in which a small amount of fluid is introduced into a small part~     of the lungs through a fine tube, and then removed for examination, to evaluate whether the~     two tests provide similar measurements. We will also evaluate the correlation between these~     molecules and other tests, including lung function, and markers of lung scarring activity,~     and tests to look at how the esophagus is working so that we can get a clearer picture of how~     this affects patients' daily lives. Finally, we will be following up patients over time with~     lung function to see whether evidence of GER into the lungs is linked with a greater~     likelihood of worsening of lung scarring in the future.~   "
109397|NCT02135536|"~     The purpose of this study is to determine the safety, tolerability, and activity of extended~     treatment with NGM282 in patients with Primary Biliary Cirrhosis.~   "
109332|NCT02136381|"~     The LiveWell research programme aims to develop evidence-based, acceptable and scalable~     interventions to improve health and wellbeing in the retirement transition.~      Life stage transitions involve changes in lifestyle and thus present key opportunities for~     behaviour change interventions. Our assessment of the literature shows that interventions~     with people of retirement age can effectively promote components of the Mediterranean diet~     (Lara et al, BMC Medicine Apr 8;12(1):60: 2014), physical activity (Hobbs et al, BMC Medicine~     Mar 19;11:75; 2013) and explicit social roles (Heaven et al, Milbank Q. Jun;91(2):222-87:~     2013).~      This study is a 2-month randomised controlled trial (RCT) with two intervention arms taking~     place in the North-East of England.~      We have developed an internet-based lifestyle programme (Living, Eating, Activity and~     Planning through retirement (LEAP)) that promotes three key health and social behaviours; 1)~     healthy eating by adopting a Mediterranean diet, 2) increasing physical activity with the use~     of a step-counter, and 3) improving social connectedness.~      Participants recruited for this study will be allocated in random order with a ratio of 2:1~     to the intervention group (LEAP) or to a control group.~      This study will evaluate the feasibility and acceptability of the LEAP intervention among~     people of retirement age and will pilot trial procedures.~      In this programme of research we have also defined a suite of outcome measures and identified~     tools appropriate for capturing the Healthy Ageing Phenotype (HAP) (Lara et al, Maturitas.~     2013 Oct;76(2):189-99). We will assess aspects of Cognition, Physical capability,~     Physiological outcomes, and psycho-social wellbeing. The feasibility and acceptability of~     these measures has yet to be determined and therefore will be formally assessed in this pilot~     RCT alongside more proximal outcomes of the intervention modules (i.e. diet, physical~     activity and social roles).~      The hypotheses to be tested in the LiveWell programme are as follows:~        -  A newly developed internet-based lifestyle programme (Living, Eating, Activity and~          Planning through retirement (LEAP)) is an acceptable tool for behaviour change among~          people of peri-retirement age.~        -  A suite of outcome measures and identified tools appropriate for capturing the Healthy~          Ageing Phenotype (HAP) is acceptable among people of peri-retirement age.~   "
109333|NCT02136368|"~     The purpose of this study is to investigate whether an exercise class with a cognitive (or~     brain) training component was more effective than a usual combined aerobic and resistance~     exercise class for older adults with cognitive complaints (such as concerns about changes in~     memory or thinking skills). It is hypothesized that the group randomized to the exercise~     class that includes additional brain training will have greater improvements in brain health.~   "
109334|NCT02136355|"~     Stereotactic ablative radiotherapy (SABR) is a new radiation treatment that delivers~     high-dose, precise radiation to small tumors in 1-3 weeks of treatment.~      The study combines SABR and surgery to treat non-small cell lung cancer. SABR will be done~     first, with surgery done approximately 10 weeks later. There will be some extra imaging done~     before and after the SABR.~      The purpose of this study is to determine how effective SABR is in killing the cancer cells,~     and if SABR can help make surgery more effective.~   "
109335|NCT02136342|"~     The purpose of the study is to explore if chlorogenic acid is safe in patients with cancer.~   "
109336|NCT02136329|"~     The objectives of the study are the following:~        -  To evaluate the pharmacokinetic profile of Sildenafil in cardiac surgery patients at~          risk of acute kidney injury~        -  To determine the safety and tolerability of Sildenafil in cardiac surgery patients at~          risk of acute kidney injury~   "
109337|NCT02136316|"~     The purpose of this study is to evaluate the safety and tolerability as well as the~     pharmacokinetics of increasing oral multiple doses of ASP7962 in healthy young male and~     female subjects.~   "
109338|NCT02136303|"~     The age-related macular degeneration (AMD) is an age-dependent, multi-factorial disease. In~     Western industrial countries, it is the main cause of visual impairments. In Germany,~     approximately 4.5 million people suffer from AMD. Genetic as well as nutritional aspects are~     mainly important in AMD development. Until now, AMD-patients are advised to use supplements~     based on the carotenoids lutein and zeaxanthin, comprised in high doses and in isolated form.~     Results showing the effects of food items (kale, spinach) rich in lutein on improvement of~     vision are scarce. And how much is needed within the diet? Within the planned project, human~     intervention studies will investigate whether an oil-based kale extract or fresh kale can be~     used to improve vision of AMD-patients and persons aged 50+ (without AMD). The first study~     will use volunteers without AMD (>18 y) to investigate if there is a dose-dependent effect of~     lutein and zeaxanthin (out of a kale extract) on macular pigment optical density (MPOD). This~     study will also compare the bioavailability of the carotenoids from the extract and from a~     supplement. A second study (also using volunteers without AMD, >18 y) will compare the~     bioavailability of lutein and zeaxanthin from the extract and from kale purée. The third~     study will investigate the effect of the oil-based kale extract on improvements of MPOD and~     vision of AMD-patients and of a control group (volunteers 50+ without AMD).~      Usually, the intestinal absorption of lutein and zeaxanthin is determined by analyzing~     changes in concentrations in blood plasma. A fast, non-invasive sampling will be evaluated to~     check the efficacy of an increased uptake of lutein. Thus, the project will test the~     usability of buccal mucosa cells to detect metabolic changes after an uptake of carotenoids.~     Besides, the determination of carotenoid contents in skin will be checked on its use as~     biomarker of carotenoids in plasma and macula.~      Thus, the planned research project will evaluate two non-invasive markers of exposition on~     their usability as markers of absorption of lutein and zeaxanthin in blood and macula. In~     addition, the minimally needed dosage of lutein and zeaxanthin for AMD prevention will be~     determined to reduce the possible risk of currently recommended doses of these compounds. The~     project will also present alternatives (kale extract, kale purée) for AMD prevention and to~     improve vision to be used instead of currently used high-dose supplements.~   "
109339|NCT02136290|"~     The primary goal of this clinical trial is to examine whether provision of portion-controlled~     prepackaged foods in the context of a reduced-energy diet prescription and counseling is~     associated with a greater degree of weight loss at three months in overweight or obese men~     and women, compared to usual care or control conditions in which the prescribed~     reduced-energy diet is to be consumed via self-selected foods. The effect on body weight and~     recognized indicators of disease risk, diet quality and cardiopulmonary fitness, as well as~     meal satiety and satisfaction, will also be examined. Participants are 184 overweight or~     obese men and women in San Diego area who will be randomly assigned to usual care or control~     conditions.~   "
109340|NCT02136277|"~     The purpose of this study is to investigate whether increases in the blood flow from the~     heart (the cardiac output), induced by the administration of intravenous fluids, lead to an~     increase in the blood flow to the vital organs, in patients undergoing bowel surgery.~      This study will involve 2 phases. Firstly, potential volunteers will be invited to meet the~     research fellow (medical doctor) undertaking this study, who will check their suitability to~     participate in the study and who will obtain informed consent.~      The second phase is the study itself which will take place whilst volunteers are having their~     bowel operation. They will attend theatre in the normal way, but once they have been~     anaesthetised (put to sleep), a special monitor called an oesophageal doppler probe will be~     placed into their oesophagus (food pipe) via the nose. This monitor is frequently used in~     bowel surgery to help assess how much intravenous fluid to administer to a patient by~     measuring the cardiac output (the amount of blood pumped out of the heart each minute). Using~     the cannula (drip) already inserted in the arm to allow administration of the anaesthetic, a~     special fluid, called an ultrasound contrast agent, will be injected into the drip, to allow~     a contrast enhanced ultrasound scan of the abdominal organs to be performed, to measure the~     blood flow to these organs. A small sample of blood will be taken from the earlobe to allow~     us to measure a chemical in the blood called lactate.~      After this, intravenous fluid will be administered in order to increase the amount of blood~     pumped out of the heart. Once the oesophageal doppler monitor suggests that an adequate~     amount of fluid has been given, a second ultrasound scan will be performed to measure whether~     blood flow to the abdominal organs has also increased. A further blood sample will be taken~     from your earlobe to measure any change in lactate level.~      At the completion of the operation, a third ultrasound scan will be performed and another~     sample of blood taken from the earlobe, to help assess blood flow to the organs.~   "
109409|NCT02135367|"~     The investigators hypothesized that intra-articular injections of Platelet-rich Plasma (PRP)~     to treat knee degenerative articular cartilage pathology could determine pain relief and~     recovery of knee function with overall clinical outcome comparable or even better than~     viscosupplementation, which is a common injective approach applied in this kind of pathology.~     To this purpose the investigators designed a double blind randomized controlled trial~     comparing PRP vs viscosupplementation.~      A power analysis has been performed for the primary endpoint of IKDC subjective score~     improvement at the 12-month follow-up for PRP. From a pilot study, a standard deviation of~     15.2 points was found. With an alpha error of 0.05, a beta error of 0.2 and a minimal~     clinically significant difference of 6.7 points corresponding at 1/3 of the documented mean~     improvement, the minimum sample size was 83 for each group. Considering a possible drop out~     of 15%, 96 patients per group are required for total 192 patients, selected according to~     well-defined inclusion criteria (see 'Eligibility criteria' section). Patients are then~     assigned to two different treatment groups, according to a randomization list. The first~     group of treatment consists of three weekly intra-articular injections of autologous PRP~     obtained with the following procedure: a 150-ml autologous venous blood sample undergoes 2~     centrifugations (the first at 1480 rpm for 6 minutes to separate erythrocytes, and a second~     at 3400 rpm for 15 minutes to concentrate platelets) to produced 20 ml of PRP. This unit of~     PRP is then divided into 4 small units of 5 ml each. One unit is sent to the laboratory for~     analysis of platelet concentration and for a quality test, 3 units are stored at -30° C.~      The second treatment group consists of patients receiving three weekly injections of~     hyaluronic acid (Hyalubrix 30 mg/2ml, Fidia Farmaceutici Spa, Italy;Molecular Weight: 1500~     kDa).~      To guarantee the blinding of the patients, all of them undergo blood harvesting to obtain~     autologous PRP which will be used only in half of them, according to the aforementioned~     randomization list. One week after the PRP production, the injective treatment starts, with 3~     weekly injections of PRP or HA. At the moment of the injection the syringe is properly~     covered to prevent the patient from discovering the substance he was receiving. After the~     injection, patients are sent home with instructions to limit the use of the leg for at least~     24 h and to use cold therapy/ice on the affected area to relieve pain. During this period,~     the use of non-steroidal medication is forbidden.~      Patients are prospectively evaluated basally and at 2, 6, and 12 months of follow-up using~     clinical subjective scores and objective parameters to determine clinical outcome (see~     'Outcome measure' section). Patient satisfaction and adverse events will be also reported.~     All the clinical evaluations are performed by a medical staff not involved in the injective~     procedure, in order to keep the study double blinded. At the end of the study, the nature of~     the injected substance is revealed to the patients.~   "
109456|NCT02134756|"~     Compare an over-the-counter dietary supplement (NutraStem Active®) and placebo over a 30-day~     intervention on aerobic exercise performance and fatigue.~      The hypothesis is that supplementation with NutraStem Active® improve aerobic performance and~     reduce subjective measures of fatigue.~   "
111909|NCT02102633|"~     The study evaluates the effect of a single oral dose of bosutinib on the single dose~     pharmacokinetics of dabigatran, a p-glycoprotein substrate, in healthy subjects.~   "
109341|NCT02136264|"~     An ongoing case study of psoriasis, shows reproducibly that ingestion of hydrogenated fats,~     and some flavourant or sweetener compounds, leads to relapse of psoriasis, and secondary food~     intolerances, followed by remission over a couple of months (cpcpsoriasis.blogspot.com).~     Hence a personalized categorical food avoidance diet averts relapse and maintains remission~     of psoriasis, with side benefit on blood pressure and other metabolic parameters (J~     Hypertension 2012; 30: e-suppl 1, poster 158). Study hypothesis: this dietary approach would~     improve the control of essential hypertension. A randomized controlled clinical trial is~     proposed to compare this dietary approach with conventional DASH-type dietary counselling. 40~     study participants will be randomly assigned to either conventional or interventional dietary~     counselling. They will be comprehensively monitored (including gene expression studies) for~     two years. Outcome criteria will include blood pressure, complications of hypertension,~     side-benefit on comorbidity, and requirement for antihypertensive drugs.~   "
109342|NCT02136251|"~     We hypothesize that there will be a low incidence of glenoid loosening with a total shoulder~     arthroplasty using an anchor peg glenoid and autologous bone grafting. In addition, we~     suggest that the absence of radiolucent lines will correlate with excellent shoulder~     function.~   "
109343|NCT02136238|"~     This study will compare the functional performance of voluntary opening (VO) and voluntary~     closing (VC) body powered prostheses. We hypothesize that the ability to sense cable tension~     and produce progressively higher pinch from shoulder force will result in advantages for the~     VC terminal device (TRS, Grip 3) in terms of proprioception and overall function. The~     specific aims of this clinical trial are to:~        1. Determine if accommodation with a VC Grip 3 prehensor will result in reduced~          compensatory motion during activity.~        2. Determine if accommodation with a VC Grip 3 prehensor will result in improved function~          in activities of daily living.~   "
109344|NCT02136225|"~     The purpose of this project is to examine the implementation and effectiveness of an~     intervention, delivered in a health care setting, to decrease home firearm access by youth.~     The investigators hypothesize that:~        1. parents who receive means restriction education provided by their primary care provider~          will be more likely to report, at the one month and one year follow-up, that they are~          storing their guns locked compared to parents who do not receive means restriction~          counseling.~        2. parents who receive a free gun locking device(s) will be more likely to report, at the~          one month and one year follow-up, that they are storing their guns locked compared to~          parents who receive means restriction counseling alone;~        3. parents whose adolescents are assessed at high risk for violence (> 5 on the Violence~          Injury Protection and Risk Screen (VIPRS)) or depression (>9 on the Patient Health~          Questionnaire-9 (PHQ-9)) will be more likely to report storing their gun(s) locked at~          the one month follow-up compared to parents whose children are assessed as low risk,~          regardless of whether they receive the counseling alone or counseling plus free locking~          devices and 4) youth whose parents receive a free gun locking device(s) will be more~          likely to report less access to guns, at one year follow-up, compared to parents who~          receive means restriction counseling alone.~   "
109345|NCT02136212|"~     The purpose of this study is to test the effects of a computerized approach/avoidance~     training (AAT) procedure in a sample of individuals diagnosed with social anxiety disorder~     (SAD). The training procedure is designed to modify automatic approach responses for positive~     social stimuli. Previous research has shown that a single administration of approach-positive~     AAT influences social behavior in the laboratory. The goal of this study is to examine the~     effects of a four-session AAT procedure on measures of positive social-emotional functioning.~     The investigators hypothesize that individuals assigned to the approach-positive AAT~     condition will demonstrate larger increases in positive affect and improvements in social~     relationship functioning from pre- to post-assessment compared to those assigned to the~     control condition.~   "
109346|NCT02136199|"~     The active strategy for dissemination and implementation of Share Evidence Based Medicine~     (EBM) will yield greater reach of clinicians, be adopted by the practices more readily, and a~     greater uptake of use amongst encounters will be seen.~      The Institute for Clinical Systems Improvement (ICSI) is a nonprofit organization with~     expertise in large-scale practice improvement at the state and national level. Largely funded~     by health organizations in Minnesota, ICSI has a sustainable model to translate evidence into~     practice, through clinical practice guidelines, shared decision making, and practice~     redesign. A partnership between these two organizations (ICSI and Mayo Clinic) may lead to a~     sustainable and innovative approach to the dissemination of evidence-based health information~     at the point of care.~      The objective of the current study is therefore to leverage the expertise of these two~     organizations to compare the impact of an active to a passive dissemination and~     implementation strategy of the ShareEBM toolkit. The aim of the study is to disseminate~     evidence-based information through the use of decision aids during encounters. The overall~     purpose of the qualitative evaluation is to understand why decision aids were used more or~     less in certain practices and what factors contributed to or hindered this uptake.~   "
109347|NCT02136186|"~     This study will evaluate the efficacy of home telemonitoring as an intervention to decrease~     hospital readmissions in patients at high risk for readmission. The overall readmission rate~     for high-risk MCF hospital patients is approximately 20%. Currently a system is in place to~     identify and score all MCF patients for their risk of readmission. This score is based on~     multiple variables including but not limited to: co-morbid conditions, patient's health~     literacy, whether they are a Medicare/Medicaid patient, their in-home social support, and~     whether they have had prior hospital admissions within the previous year. The literature~     shows that home telemonitoring of patients has had mixed results for effectiveness at~     preventing hospitalizations and emergency department visits. Many of these reports have~     restricted studies to patients with specific diseases or general characteristics; some have~     shown improved results while others have not. No study has examined patients who are high~     risk for readmission to determine if home telemonitoring for 30 days post-discharge reduces~     the risk for 30-day readmission.~   "
109348|NCT02136173|"~     The effect of the balloon on weight loss is investigated by multiple studies. However, the~     effect of the sequential balloons is not studied yet.~   "
109531|NCT02133768|"~     To describe the need for re-catheterization and incidence of urological complications of~     routine use of perioperative fixed urinary catheter (KAD) for up to 24 hours of fast-track~     THA and TKA~   "
109350|NCT02136147|"~     ADHD medication of children and adolescents is becoming increasingly common. Clinical~     experience and scientific studies have proven that approximately 30% of children/adolescents~     with ADHD do not benefit from this treatment. However, there is insufficient knowledge about~     who these children are. All children and adolescents, who start treatment with ADHD~     medication at public Child and Adolescent Psychiatry units in Stockholm and on Gotland, will~     be asked to participate in the study. The investigators intend to monitor the~     patients´clinical symptoms and possible side-effects after treatment start. The investigators~     will collect background information and saliva samples from the patient and his/her parents~     to be able to study if there are any genetic (hereditary) or other markers that can predict~     positive or negative outcomes of the ADHD medication. With this information, the~     investigators aim at, to a greater extent, be able to individualize treatment choices for~     children and adolescents with ADHD without unnecessary, costly and possibly unfavorable~     treatment attempts.~   "
109351|NCT02136134|"~     The purpose of this study is to assess the effects of administration of daratumumab when~     combined with VELCADE (bortezomib) and dexamethasone compared with bortezomib and~     dexamethasone alone, for participants with relapsed or refractory multiple myeloma.~   "
109352|NCT02136121|"~     To determine the feasibility of representative urologic procedures as measured by the rate of~     conversions~   "
109353|NCT02136108|"~     The OPEN study has two aims: The first is to identify what helps to keep patients involved~     with a Medicaid chronic pain management program and to identify features of an ideal~     text-message-based program for people enrolled in the program. The second aim is to develop~     the text-message-based program (OPENtext), then find out how useful this intervention is~     compared to a patient navigator intervention (OPENnav) for increasing patient engagement,~     improving patient's motivation to manage their chronic pain, and improving patient confidence~     in self-managing their chronic pain condition.~   "
109354|NCT02136095|"~     Intraoperative fluorescent cholangiography (IFC) with concomitant fluorescent angiography is~     a recently developed method for non-invasive visualisation of the relevant anatomy during~     laparoscopic cholecystectomy. The objective of this study was to assess the time required by~     routine-use of IFC and to evaluate success-rate of the procedures.~      Methods Thirty-five patients scheduled for laparoscopic cholecystectomy and operated by the~     same surgeon were consecutively enrolled. A standardized protocol with IFC including~     concomitant angiography was performed during laparoscopic cholecystectomy. Intra-operative~     time-registration and exposure of predefined anatomical structures were recorded.~   "
109355|NCT02136082|"~     Building upon the successful qualitative Phase I of the study, Phase II commences in month~     10. The Project manager and research staff will recruit 600 women living with AIDS (WLA) and~     their oldest child between the ages of 3 and 8. The WLA will be recruited from Primary Health~     Centers (PHCs) randomly selected from 72 closest PHCs in terms of HIV prevalence in the rural~     Andhra Pradesh (AP) area of Nellore. WLA will be recruited by means of approved flyers posted~     in selected PHCs. Interested WLA will approach the research staff, stationed at the PHC to be~     screened for eligibility via a consent script. Once eligibility is determined for the WLA,~     based upon the following criteria: age, HIV and ART status (validated by ART and HIV card);~     having a child (3-8 years) and whether or not the WLA was a participant of the previous~     intervention group from the Asha pilot study, a parental consent will be obtained from the~     WLA for permission to include her oldest child in the study. The oldest child between 3-8~     years of age will be brought in to the research office or PHC (after mother speaks with the~     child at home). All children will have blood work drawn and physical health assessment on~     their first visit (total of 15 minutes). All eligible WLA will undergo a second consent for~     enrollment. General Procedure: Following informed consent, the WLA will be randomly assigned~     into one of four programs 1) Asha Support Only; 2) Asha Support + Training; 3) Asha Support +~     Food; or 4) Asha Support + Training + Food. After blood draw and physical assessment of the~     WLA, an appointment will be made for the assigned interviewer (blinded to program) to visit~     the WLA at their home preferably (or other location of choice) to conduct several 24 hour~     dietary assessments. Urine will be collected in labeled bottles on the morning after the 3rd~     day of the diet recall by the interviewer and sent directly to the lab in a cooler. Also, on~     the same day, the baseline assessment will be entered into the PC tablets; 50 minutes~     estimated with breaks). After a longer break, the WLA will then be asked to respond to~     additional questions about the sociodemographic and psychomotor development of their child~     (about 30 minutes). Interviewers will visit the WLA monthly until the end of the intervention~     (month 6) to provide individual weekly Asha Support and conduct group sessions and collect~     ongoing data, 24-hour recall, and ART pill count for WLA, and follow up questionnaires at 6-,~     12- and 18-months.~   "
109356|NCT02136069|"~     This is a multicenter, Phase III, randomized, double-blind, double-dummy, parallel-group~     study to evaluate the safety, efficacy, and tolerability of etrolizumab compared with~     infliximab in treating participants with moderate to severe ulcerative colitis (UC) who are~     naive to tumor necrosis factor (TNF) inhibitors. Participants will be randomized in a 1:1~     ratio to receive either etrolizumab 105 (milligrams) by subcutaneous (SC) injection [SC]~     every 4 weeks [Q4W]) + placebo (intravenous [IV] infusion at Weeks 0, 2, and 6, then every 8~     weeks) or infliximab 5 milligrams/kilogram (mg/kg) IV at Weeks 0, 2, and 6, then every 8~     weeks) + placebo (SC Q4W). Time on treatment is 54 weeks.~   "
109357|NCT02136056|"~     The purpose of the current study is to determine the efficacy of a self-management course for~     workers on sick-leave as an add-on to standard rehabilitation care and follow-up (treatment~     as usual). Outcomes are registry based measures of return to work, and questionnaire based~     measures of well-being and quality of life.~      We thus, hypothesize that the program will improve workers return to work rates and~     self-reported/psychological well-being.~   "
109358|NCT02136043|"~     The purpose of the study is to evaluate how treatment with Kinetic Oscillation Stimulation~     (KOS) in the nasal cavity in patients with non-allergic rhinitis can be optimized to minimize~     any patient reported discomfort during treatment procedure.~   "
109359|NCT02136030|"~     To evaluate the safety and efficacy of liposomal amphotericin B and amphotericin B~     deoxycholate with or without flucytosine followed by fluconazole for the treatment of~     cryptococcal meningitis.~   "
109360|NCT02136017|"~     To evaluate the safety of the post-licensed influenza virus vaccine made of Changchun~     Institute of Biological Products Co.,Ltd.~   "
109361|NCT02136004|"~     The objective of this trial is to demonstrate the safety and effectiveness of the Rex Medical~     Closer Vascular Sealing System in sealing femoral arterial access sites.~   "
109362|NCT02135991|"~     Young people can engage in a variety of negative behaviors—such as drug use, underage~     drinking, and premarital sex—that exact a high toll on local communities. These activities~     are often the target of community-based prevention efforts. Getting To Outcomes (GTO) is an~     approach that includes a toolkit, technical assistance, and training, organized around a~     10-step process, that helps communities plan, implement, and evaluate the impact of their~     programs that attempt to prevent these negative behaviors. This study will examine the degree~     to which Getting To Outcomes helps Boys and Girls Clubs implement an evidence based drug~     prevention program.~   "
109363|NCT02135978|"~     The purpose of this study is to determine if a shoulder exercise program can prevent the~     onset of shoulder pain and improve community participation in persons who have a spinal cord~     injury (SCI). Upon entry into the study patients will have pain-free shoulders and will be~     followed for 3 years to determine rate of shoulder pain development. Patients will learn a~     simple shoulder home exercise program and will be instructed on techniques to protect their~     shoulder during wheelchair propulsion, transfers and activities of daily living. Patients~     will be instructed to perform the home exercise program 3 days per week. Two types of~     treatment (training) delivery approaches that have been documented to reduce chronic shoulder~     pain will be compared. The rate of shoulder pain development for the two groups will be~     compared to the rate of shoulder pain development in the historical control group. The~     investigators hypothesize that the rate of shoulder pain development will be lower in the~     experimental treatment groups compared to the historical control group. Any differences~     between the two treatment delivery approaches for the experimental treatment groups will help~     to provide guidelines for the most effective delivery approach of a shoulder pain prevention~     program.~   "
109364|NCT02135965|"~     The purpose of this study is to define a ratio of Caffeine and albuterol that gives a~     synergistic increase in metabolic rate.~   "
109365|NCT02135952|"~     Diabetes mellitus (DM) is a widely prevalent disease associated with several major systemic~     and oral complications, such as periodontitis. The use of adjunctive local and/or systemic~     antimicrobials has been proposed to improve the clinical and glycemic outcomes of the scaling~     and root planing (SRP) in diabetic subjects. The combination of metronidazole (MTZ) and~     amoxicillin (AMX) has been largely recognized as an effective therapy for improving the~     clinical and microbiological outcomes of SRP in the treatment of with chronic periodontitis~     (ChP). However, no previous clinical trials to date have evaluated the effects of this~     antibiotic combination in the treatment of diabetic subjects with periodontitis. Therefore,~     the aim of this randomized clinical trial (RCT) will be to evaluate the clinical and~     microbiological effects of the use of MTZ+AMX as adjuncts to SRP for the treatment of type 2~     diabetic subjects with generalized ChP.~   "
109366|NCT02135939|"~     In this randomized study the investigators aim to determine the effects of a whole-food~     plant-based vegan diet on markers of inflammation and glucometabolic profile in patients with~     cardiovascular disease. The investigators hypothesize that a whole-food plant-based vegan~     diet will reduce markers of inflammation and improve glucometabolic profile compared with the~     American Heart Association (AHA)- recommended diet at 2 months follow-up in patients with~     coronary artery disease (CAD). The investigators are also evaluating endothelial function~     using the EndoPAT device and stool microbiome.~   "
109367|NCT02135926|"~     the purpose of this study is to to compare the safety and effectiveness of stent-retrievers~     as a device class group with best medical care alone in the treatment of acute ischemic~     stroke (AIS) in patients who are not eligible for IV-tPA up to 8 hours of symptom onset.~   "
109368|NCT02135913|"~     This is a pilot study to determine the association between Vitamin D deficiency in obese~     children and low high density lipoprotein (HDL) and dysfunctional HDL.~   "
109369|NCT02135900|"~     The goals of the project is to evaluate the effects of Heliox therapy on obstructive sleep~     apnea syndrome (OSAS).~   "
109370|NCT02135887|"~     This is a randomized, double-blind, placebo-controlled multi-center phaseⅢstudy to evaluate~     efficacy and safety of oxaliplatin-based chemotherapy plus MB-6(320 mg/capsule, 6 capsules~     tid) in patients with stage 3 colorectal cancer who underwent surgical excision of their~     primary tumor.~   "
109371|NCT02135874|"~     The goal of this clinical research study is to learn if the combination of clofarabine,~     idarubicin, cytarabine, vincristine, and dexamethasone, with or without rituximab, can help~     to control mixed phenotype acute leukemia. The safety of this combination will also be~     studied.~      This is an investigational study. Clofarabine is FDA approved and commercially available to~     treat acute lymphoblastic leukemia (ALL) in children. Idarubicin and cytarabine are FDA~     approved and commercially available to treat acute myeloid leukemia (AML). Rituximab is FDA~     approved and commercially available to treat various types of lymphoma and leukemia. The use~     of these drugs in combination with vincristine and dexamethasone to treat mixed phenotype~     acute leukemia is investigational.~      The study doctor can explain how the drugs are designed to work.~      Up to 60 participants will be enrolled in this study. All will take part at MD Anderson.~   "
109372|NCT02135861|"~     Transient receptor potential vanilloid 4 (TRPV4) channel blockade may be promising in the~     treatment of pulmonary oedema and dyspnoea in heart failure (HF) and acute decompensated~     heart failure (ADHF) patients by re-establishing the alveolar septal barrier. Dynamic~     contrast enhanced (DCE) Magnetic Resonance Imaging (MRI) is an established technique for~     assessing changes in vascular permeability and interstitial water volume. The aim of this~     study is to establish the potential utility of DCE-MRI as a novel endpoint for dose ranging~     and proof of mechanism studies of TRPV4 blockers. The DCE-MRI markers of vascular~     permeability and pulmonary oedema will be measured in subjects with HF (group 2) and healthy~     volunteers (HV) (group 1) at rest to determine if there is a difference between the two~     populations. Apart from this, exercise induced changes relative to rest in interstitial~     volume and exchange rate will be evaluated in both HV and subjects with HF. Additionally, the~     capability of DCE-MRI to detect changes in interstitial lung fluid in patients with acute~     decompensated heart failure (ADHF) (group 3) will be investigated. DCE-MRI markers of~     pulmonary oedema will be assessed when patients are initially hospitalized with ADHF and~     subsequently after receiving standard of care treatment to determine whether differences can~     be detected by this methodology.This study will enrol a sufficient number of subjects to have~     at least 24 subjects in Group 1 and 2 (group 1:12 HV and group 2: 12 subjects with HF) and~     atleast 5 subjects in Group 3. For each subject, the MRI data must be of sufficient quality~     to enable DCE-MRI modelling from 2 Sessions. For group 1 and 2, the subjects will have~     screening visit and 3 MRI sessions. For the first scanning session, subjects will undergo the~     baseline procedure. The second imaging session will occur approximately one week later to~     measure within subject variability. A third imaging session (which will be conducted in 2~     visits) will incorporate a bicycle exercise challenge prior to the MRI scan, and this third~     scan will be performed approximately one to three days after the second imaging session. For~     group 3: Screening will occur during hospitalization for eligibility. Session 1of MRI will be~     conducted while the subject is still hospitalized. Session 2 will be conducted within 4 weeks~     of the first scan, when the signs of pulmonary oedema are considered to be resolved. If a~     subject's pulmonary oedema has not resolved at Session 2, then the subject will be not be~     scanned by MRI at Session 2 and will be brought back for Session 3 up to 4 weeks after~     Session 2 for their second MRI.~   "
109373|NCT02135848|"~     This is a multi-center, randomized, blinded, placebo controlled study to evaluate the safety~     of GSK1278863 and its acute and short-term (e.g. 14d) effects on calf muscle endurance and~     walking ability in subjects with PAD and symptomatic claudication.~   "
109374|NCT02135835|"~     The purpose of this study is to evaluate the efficacy and safety of Shenfu Zhusheye in~     patients with acute heart failure.~   "
109375|NCT02135822|"~     The purpose of this study is to determine the efficacy and safety of nanoparticle~     albumin-bound paclitaxel (nab-paclitaxel) plus gemcitabine as first-line treatment in Chinese~     patients with advanced pancreatic ductal adenocarcinoma.~   "
109377|NCT02135796|"~     BACKGROUND: Echocardiography can provide evaluation of right or left ventricular dysfunction~     and volume status during resuscitation of patients with sepsis and septic shock and guide~     intravenous vasopressor and fluid therapy. While there are numerous echocardiographic studies~     regarding cardiac function and volume status in patients with established shock, there are~     none that describe these during the early resuscitation of septic shock.~      The study objective is to correlate echocardiographic findings with clinical parameters and~     net fluid balance measured during the early resuscitation of critically ill patients with~     sepsis and septic shock.~      Aim 1) correlate echocardiographic findings of cardiac function with physiologic markers in~     the early hours of resuscitation~      Aim 2) correlate cardiac function and fluid status with clinical outcomes~      Aim 3) evaluate the change in cardiac function over time in patients with sepsis and septic~     shock~      Aim 4) evaluate long term clinical outcomes for patients with sepsis and septic shock.~   "
109378|NCT02135783|"~     Decompressive craniectomy has been reported for the treatment of patients with intracerebral~     hemorrhage. But no prospective randomised controlled trials have yet been undertaken to~     confirm its effect.The purpose of the study is to determine whether decompressive craniectomy~     post hematoma removal surgery after intracerebral hemorrhage will reduce the chances of a~     person dying or surviving with a long term disability.~   "
109379|NCT02135770|"~     Sepsis is a clinical syndrome which infection trigger systemic inflammatory response.~     Uncontrolled inflammatory process leads to multiple organ dysfunction and cause early~     mortality in severe sepsis. Unfractionated heparin is an anticoagulant that widely used~     either for DVT prophylaxis or treatment of disseminated intravascular coagulation. Heparin~     also have an anti-inflammatory effect through downregulates nuclear factor kappa B and tumor~     necrosis factor alpha.~      Aim of this study is to determine effects of low dose unfractionated heparin treatment on~     inflammation in severe sepsis patient.~   "
109380|NCT02135757|"~     This is a phase IV multicenter trial to evaluate real-world health outcomes, economic impact~     and resistance mechanisms of panitumumab in the treatment of patients with~     chemotherapy-refractory metastatic colorectal cancer (mCRC).~      This study will address two anticipated issues surrounding personalized medicine and~     treatment with panitumumab. First, it will enable to assess the economic impact of~     panitumumab in a real-life setting (HEOR study). Second, it will identify new blood-based~     mechanisms of resistance, which may lead to new avenues for combination therapy in metastatic~     colorectal cancer (Blood study).~      The primary objective is to collect information on quality of life and health care resource~     utilization by patients diagnosed with metastatic colorectal cancer. The secondary objectives~     are to confirm survival data, to assess the quality of life of patients and to assess the~     health care resource utilization of patients. The blood biomarker study objective is to~     determine blood-based biomarkers of response or resistance to panitumumab.~      Patients with a mutated KRAS gene will be treated with standard-of-care (SOC) and will~     participate to the HEOR study only. Patients with a non-mutated (wild type) KRAS gene will be~     treated with panitumumab and will participate to the HEOR study and to the blood biomarker~     study.~      During the course of the study, data will be collected on quality of life and work~     productivity. Patients will be asked to fill a set of questionnaires at their recruitment in~     the study and at every 3 months after treatment initiation. For patients participating to the~     blood study (patients with a wild type KRAS), blood samples will be collected before patients~     start their treatment, at every treatment and when they discontinue their treatment.~   "
109381|NCT02135744|"~     Hospital readmissions for acute exacerbations of chronic obstructive pulmonary disease~     (AECOPD) pose burdens to the healthcare system and patients. The aim of this study was to~     determine whether a screening and educational tool, administered prior to discharge, would~     result in a decrease in the rate of hospital readmissions.~   "
109382|NCT02135731|"~     We are studying patients' abilities to correctly identify the prescription medications they~     are taking. We are interested in understanding what tools will help patients correctly~     identify their medications. People participating in this study will be asked to either review~     a paper printout of their medication list or a computer program with their medications. The~     program will show the names and pictures of the medications. In either situation,~     participants will be asked to indicate if they are taking the medications as prescribed. We~     will then compare reported adherence between each medication review process. Participation~     may help the program developers improve the product.~   "
109383|NCT02135718|"~     This is a multicenter, stratified, and randomized, open-label, placebo study in subjects with~     asthma to compare inhalers, ELLIPTA a new dry powder inhaler (DPI) and metered dose inhalers~     (MDI). This study is conducted to evaluate subject's preference of several inhaler-specific~     attributes individually between an existing MDI and the ELLIPTA a dry powder inhaler.~     Subjects who have not used the ELLIPTA inhaler in the past 6 months and their asthma must be~     controlled on their current therapy were enrolled. Subjects meeting the eligibility criteria~     will be stratified according to their current inhaler use (stable for the past 3 months): 1.)~     Currently using a DPI as an inhaled asthma controller therapy OR 2.) Currently using an MDI~     as an inhaled asthma controller therapy (No fluticasone MDI use in the last 3 months) OR 3.)~     Currently using no inhaled asthma controller therapy (this includes patients using a LTM~     and/or SABA only). Once stratified, eligible subjects were randomized (1:1) to one of two~     sequences for using the inhaler: ELLIPTA inhaler once daily in Period 1 followed by MDI twice~     daily in Period 2 or MDI twice daily in Period 1 followed by ELLIPTA inhaler once daily in~     Period 2 for for 5-9 days each. In addition, subjects will be randomly assigned (1:1~     allocation) to receive one of two sets of questions: Version 1 presents response options in~     the order of ELLIPTA inhaler, MDI, No preference; Version 2 presents response options in the~     order of MDI, ELLIPTA inhaler, No preference. At the end of the second trial period, subjects~     answered questions which assessed their preference of inhaler attributes. ELLIPTA is a~     registered trademark of the GSK group of companies.~   "
109384|NCT02135705|"~     This global product exposure registry is a multicentre, long-term, prospective, observational~     cohort study (exposure registry), designed to evaluate the long term safety and effectiveness~     of lomitapide.~   "
109432|NCT02135068|"~     This study is designed to look at how snacking during exercise may help prevent low blood~     sugars while subjects are on the closed loop artificial pancreas. This system uses a~     continuous glucose sensor, an insulin pump, and a computer program that automatically~     determines how much insulin to give based on the sensor glucose level.~   "
109385|NCT02135692|"~     This is a multi-center, open-label, long-term study of subcutaneously (SC) administered~     mepolizumab 100mg in addition to standard of care (SOC), in subjects with severe eosinophilic~     asthma. This study will enroll a subset of subjects from Study MEA115661 who have~     demonstrated clear benefit from therapy and who without continuation of mepolizumab therapy~     are individuals at greatest risk of serious deterioration of their health status. In order to~     target individuals at greatest risk for serious deterioration of their health status, only~     subjects from the MEA115661 study with a history of life-threatening or seriously~     debilitating asthma, will be allowed to participate. Subjects meeting all of the eligibility~     criteria for the study will be offered the opportunity to consent for this study of up to 128~     weeks in length (including the Follow-Up Visit). This study will give opportunity to extend~     the collection of clinical data for long-term use and further assess the sustainability of~     efficacy in a population likely to experience significant loss of asthma control and the need~     for higher doses of systemic steroids if returned to SOC only.~   "
109386|NCT02135679|"~     Patients with NSCLC who undergo radiation as part of a definitive course of treatment will be~     enrolled. Blood collections will be obtained before, during, and after radiotherapy. We will~     collect demographic and treatment data and explore & describe the pattern of CTC detection in~     all patients~   "
109387|NCT02135666|"~     The purpose of this study is to assess the long-term persistence of immunity to hepatitis A~     and B in adults who were vaccinated 16-20 years earlier with the combined hepatitis A and~     hepatitis B vaccine, Twinrix.~   "
109388|NCT02135653|"~     This study will ascertain the feasibility and effect of Eischens yoga interventions on~     radiationrelated fatigue, sexual dysfunction and urinary incontinence in stage I /II prostate~     cancer patients undergoing radiotherapy with photons and/or protons without prostatectomy.~     Subjects must be smoke free and have not taken regular yoga classes 6 months prior to~     enrollment. Subjects will participate in twice weekly yoga sessions for 8 weeks and complete~     4 quality of life forms 5 times during study.~   "
109389|NCT02135640|"~     This study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of~     denosumab administered subcutaneously to healthy adults in China.~   "
109390|NCT02135627|"~     Introduction: Gastrointestinal (GI) bleeding arising from malignant tumors is increasingly~     recognized as a result of oncological advances and improved detection methods, and stems from~     local vessel damage and tumor invasion with associated derangements in the hemostatic~     system(1, 2). Although conventional endoscopic hemostasis methods improve outcomes in UGIB~     due to peptic ulcers and other non-variceal benign bleeding lesions of the upper, and perhaps~     the lower GI tract, data on their use in hemorrhagic, upper or lower gastrointestinal~     neoplasms are scarce and associated with varying success in initial hemostasis and high~     rebleeding rates(3-7). Other recognized single or multimodality treatment approaches include~     radiation therapy, interventional angiography, and surgery. All exhibit disappointing~     rebleeding rates, and in the case of emergency surgery, high mortality(4, 8-11). Challenges~     associated with bleeding tumors include hematological derangements such as thrombocytopenia,~     disseminated intravascular coagulation, and neutropenia, as well as the endoscopic~     manipulation of friable, diffusely bleeding surfaces when attempting hemostasis(2, 12, 13).~     The recent advent of TC-325 (HemosprayTM) to Canada, Europe and Asia - referred henceforth as~     TC-325 - may provide a highly adapted novel endoscopic hemostatic therapeutic alternative for~     this refractory clinical entity, with promising uncontrolled observations having just been~     published by our group(13) and others(14). More robust controlled evaluative data are now~     needed. We propose to study the use of TC-325 in upper and lower malignant GI bleeding~     compared to contemporary standard of care, and more specifically seeks funding for a pilot~     study to inform a subsequent peer-review application for a larger, more definitive randomized~     clinical trial (RCT).~   "
109391|NCT02135614|"~     The primary objective of this study is to evaluate the effects of presatovir on respiratory~     syncytial virus (RSV) viral load in RSV-positive adults who have been hospitalized with acute~     respiratory infectious symptoms.~      Participants will receive 1 dose of presatovir on Day 1 and followed for 27 days postdose.~     Nasal swabs will be collected at each study visit (excluding Day 28) and assayed for change~     in viral load as the primary endpoint.~   "
109392|NCT02135601|"~     Water exchange method has been shown to reduce medication requirement and pain experienced~     during colonoscopy. It may increase the adenoma detection rate (ADR). Water exchange provides~     salvage cleansing and the refractive index of water (n equals about 1.3) is larger than that~     of air, which creates optical distortion that likely contributes to objects appearing larger~     underwater, making smaller lesions easier to visualize and it may help draw attention to~     those smaller lesions during withdraw. These principles facilitate to the higher adenoma~     detection rate.~      There is a large number of literature on the adenoma detection rate during water exchange~     colonoscopy, but most studies have been conducted in only one centre, simple-size, and under~     sedation patients, the influence of adenoma detection rate under unsedation patients was~     unclear.~      The aim of this study is to compare the ADR of colonoscopy by using the water exchange method~     versus the conventional air method in unsedation patients in multiple centers in China.~   "
109393|NCT02135588|"~     The purpose of this study is to evaluate the efficacy and safety of intrapleural dornase alfa~     and tPA administered to patients with clinical failure of small-bore chest tube with~     persistent pleural effusions or malignancy-related loculated effusion to improve pleural~     drainage.~   "
109394|NCT02135575|"~     The hypothesis of the present study is that physical training can oppose detrimental changes~     in cardiovascular and metabolic health associated with estrogen loss after menopause.~   "
109395|NCT02135562|"~     This pilot clinical trial studies protein-sparing modified fast (PSMF) intervention for~     weight loss in obese endometrial cancer survivors. The PSMF is a diet that is very low in~     carbohydrates and calories, designed to induce fast, safe weight loss. The diet consists of~     only lean meats (beef, pork, poultry, and seafood) in amounts adequate to meet protein~     requirements based on the individual's body weight. The PSMF may help endometrial cancer~     survivors achieve significant weight loss, reduce the risk of chronic disease, and improve~     quality of life.~   "
109556|NCT02133443|"~     Determining the optimal Neurally Adjusted Ventilatory Assist (NAVA) level remains~     challenging, and several methods have been suggested. However none of them seems easily~     utilisable. Thus the investigators propose to test a way of NAVA level titration according to~     ventilator comfort.~   "
109398|NCT02135523|"~     1. Title: The efficacy of involved-field radiation therapy for residual or locoregionally~          recurrent epithelial ovarian cancer after definitive treatment; Multi-institutional~          phase 2 clinical trial~        2. Study period: 2014.04~2018.04~        3. Objective: To determine whether involved-field radiation therapy will prove to be~          improve 2-year progression free survival for residual or locoregionally recurrent~          epithelial ovarian cancer patients after definitive treatment.~        4. Patient Selection: primary epithelial ovarian cancer (Required sample size: 70)~        5. Planned number of patients~             -  YUHS database have 149 FIGO stage III patients treated with debulking surgery and~               adjuvant platinum-based chemotherapy 2.~             -  Of these patients, 90 patients experienced locoregional failures, and then the~               investigators selected 44 patients who could be treated effectively with IFRT based~               on MDACC suggestion.~             -  Median interval to failure was 9 months in these patients~                  -  Hypothesis; IFRT reduces 44% hazard of progression compared with patients~                    without IFRT~                  -  Sample size; two-sided, accrual time = 24 mo, f/u time= 36 mo. α= 0.05, power~                    = 0.80 Null progression-free median survival = 9 mo Alt progression-free~                    median survival = 16 mo Calculated sample number = total 27 patients Drop rate~                    = 10% • Total sample number = 30 patients Estimated Enrollment : 30~                    participants~      Drop rate = 10%~        -  Total sample number = 70 patients 6. Radiation therapy: Participants will receive~          involved-field radiotherapy (external beam radiotherapy or brachytherapy) over 45Gy with~          1.8-2.0 Gy fraction, five times per week for residual or locoregionally recurrent~          epithelial ovarian cancer after definitive treatment~        -  Target volume~             -  directed to gross disease plus a high-risk clinical target volume (CTV) that~               included the postoperative bed or the prechemotherapy extent of disease with a 1-~               to 1.5-cm margin, excluding uninvolved clinical structures~             -  Additional CTVs were designated according to the risks of microscopic disease~               spread, proximity to critical structures, and other risk factors for complications.~             -  Nodal CTVs included grossly involved lymph node sites, extending to cover adjacent~               uninvolved regions.~        -  Modality; 3-dimensional conformal RT including electron, intensity-modulated RT, proton~          beam RT 7. Patient assessment: Participants will be followed at 1, 3, 6, 12, 18 and 24~          month after radiation therapy 8. Key words: ovarian cancer, involved-field radiation~          therapy, progression free survival~   "
109399|NCT02135510|"~     In this phase III non-inferiority trial, the aim is to evaluate whether metoclopramide and~     palonosetron prophylactic antemetic treatment are non-inferior to dexamethasone with regard~     to its efficacy to prevent delayed chemotherapy-induced nausea and vomiting (CINV) induced by~     non- anthracyclines plus cyclophosphamide (AC) based moderately emetogenic chemotherapy~     (MEC).~   "
109400|NCT02135484|"~     The goal of this clinical research study is to learn more about how the study drug alpharadin~     (Radium-223) works in patients who have CPRC that has spread to the bone.~   "
109401|NCT02135471|"~     Smoking has a negative effect on the predictability and stability of root coverage procedures~     because of decreased blood supply and fibroblast activity. Long-term evaluation of this~     procedure in smokers is important for clinical decision making, because it provides~     information about the stability of results over time. In smokers, enamel matrix derivative~     (EMD) used at acellular dermal matrix graft (ADMG)/ soft tissue interface could be an~     alternative to improve the deficient healing potential, since EMD has the capability of~     stimulating angiogenesis. At the ADMG/ root surface interface, it could improve the deficient~     fibroblast activity in smokers and therefore reduce the presence of a long junctional~     epithelium. The aim of this randomised controlled clinical study was to investigate whether~     EMD contributes to the root coverage of gingival recessions performed with ADMG in smokers~     during a 12-month follow-up.~      Twenty smokers with bilateral Miller Class I or II gingival recessions ≥ 3 mm will be~     selected. The test group will be treated with an association of ADMG and EMD, and the control~     group with ADMG alone. Some clinical parameters as: probing depth, relative clinical~     attachment level, gingival recession height, gingival recession width, keratinized tissue~     width and keratinized tissue thickness will be evaluated before surgery and after twelve~     months.~   "
109402|NCT02135458|"~     Heart failure is the principle cause of hospitalisation for people over 65. the assumption is~     that a system of home based telemonitoring can reduce the rate of unscheduled hospitalisation~     or rehospitalisation for heart failure (compared to a care package alone), This randomised~     controlled pilot study should assess the feasibility in terms of patient inclusion and~     follow-up.~   "
109403|NCT02135445|"~     The purpose of this study is to evaluate the efficacy of TAK-385 for achieving and~     maintaining testosterone suppression.~   "
109404|NCT02135432|"~     The study is a randomized, double-blind, placebo-controlled, multiple-dose, pilot study of~     orally-administered ivacaftor in subjects with chronic obstructive pulmonary disease.~     Subjects will be administered the study drug ivacaftor 150 mg (or placebo) twice daily (BID).~   "
109405|NCT02135419|"~     This randomized phase III trial compares topical or ablative treatment with active monitoring~     in preventing anal cancer in patients with human immunodeficiency virus (HIV) and high-grade~     squamous intraepithelial lesions (HSIL). Anal HSIL is tissue in the anal canal that has been~     damaged by infection with human papillomavirus (HPV) and is at risk for turning into anal~     cancer. It is not yet known if treating HSIL is more effective than active monitoring in~     preventing patients from developing anal cancer.~   "
109406|NCT02135406|"~     The primary goals: determine the safety, tolerability and engraftment potential of CART-19 T~     cells in patients undergoing salvage ASCT after early relapse following first ASCT. CART-19~     cells transduced with a lentiviral vector to express anti-CD19 scFv TCR(zeta):41BB~     administered by intravenous infusion using a single infusion of 1-5x108 CART19-transduced T~     cells on day +2 after autologous stem cell infusion following high-dose melphalan.~   "
109407|NCT02135393|"~     The aim of this study is to test the assumption that, in humans, folic acid, a dietary~     supplement is biotransformed (reduced and methylated) to the natural circulating plasma~     folate 6S-5Methyltetrahydrofolic acid (5-MTHF) in the intestinal mucosa.~   "
109408|NCT02135380|"~     Despite intense research efforts and clinical trials, there is still no effective treatment~     that can prolong the survival of patients with IPF. Conventional therapeutic approach~     includes combination of corticosteroids, anti-oxidants, immunodepressants and immune~     modulatory anti-fibrotic agents to be discontinued 20 days before screening. The only, so~     far, therapeutic approach that has been proven effective in terms of prolonging patient's~     survival is lung transplantation. Nonetheless, not all the patients with IPF are eligible for~     lung transplantation; there is a significant proportion of these patients that finally~     succumb while waiting in a lung transplantation list. Therefore, there is critical need for~     more effective and reliable therapeutic modalities5. Adult Stem Cells (ASCs) seem to~     represent one of these. Therefore, it is conceivable to assume that adult-stem cells can be~     easily and safely be applied as a novel therapeutic agent in chronic and fatal lung diseases,~     including chronic obstructive pulmonary disease (COPD) and IPF.~      Therefore, there is an urgent need to provide a safe, effective and affordable treatment~     option for IPF patients. New diagnostic, prognostic and therapeutic strategies need to be~     developed to reduce the burden of IPF. Given the present lack of appropriate treatment~     adjunctive in the therapy of IPF, adipose derived stromal vascular fraction provides new~     opportunities for development of the same.~      MSCs are having anti-fibrotic activity and hence may be excellent source to tackle pulmonary~     fibrosis and hence could be explored for their therapeutic potential for treating Idiopathic~     pulmonary fibrosis. MSC's also display membrane-bound and insoluble secreted molecules~     involved with cell attachment to neighbouring cells and to the extra cellular matrix.18 This~     cell surface configuration may enable mesenchymal stem cells to home from bloodstream to~     mesenchymal tissue.14~      As limited clinical information is available about use of SVF and MSC in the IPF patients~     hence this Open Label, Prospective, Randomized multi center comparative study has been~     undertaken to explore the tolerability & effectiveness of SVF in one treatment arm and MSC in~     second treatment arm in IPF patients.~      Adipose derived stromal vascular fraction and Mesenchymal Stem Cells has been found in~     preclinical studies to be safe and effective~   "
109410|NCT02135354|"~     This project (funded by the IWT-TBM program) will organize a randomized placebo-controlled~     multicenter intervention trial in 500 COPD patients to study the effectiveness and safety of~     azithromycin therapy in the acute setting of COPD exacerbations requiring hospital admission.~     Although long-term use of azithromycin is proven effective to prevent exacerbations, inherent~     risks outweigh the benefits. By reducing the dose and duration of the azithromycin treatment~     and by restricting the treatment to acute periods with highest risk for treatment failure,~     benefits may counterbalance potential side effects, which may result in a new treatment~     strategy for these acute events.~      The present study is designed by the services of respiratory medicine of the Leuven and Ghent~     University hospitals but will run in total in 17 different large hospitals in Belgium, of~     which 12 are located in Flanders.~   "
109411|NCT02135341|"~     The objectives of this study is to evaluate and compare the efficacy and safety between 100 U~     of botulinum toxin A (BoNT-A) suburothelial injections and combined 50 U of BoNT-A~     suburothelial injections and 50 U urethral injection for the treatment of detrusor~     overactivity and inadequate contractility (DHIC) refractory to antimuscarinic agents~   "
109412|NCT02135328|"~     The purpose of this study is to use a community based participatory action research (CBPAR)~     approach to 1) create radio stories about Somali, Latino and Hmong families' real success~     stories with type 2 diabetes mellitus (DM) in managing their disease through implementation~     of healthful lifestyle behaviors (nutrition and physical activity), and 2) test the~     effectiveness and acceptability of radio stories on participant intentions to engage in or~     improve healthful lifestyle behaviors. Participants in the Intervention condition listened to~     the radio stories and the participants in the control condition listened to an audio~     brochure with relevant information. We hypothesized that the intervention participants would~     report higher intensions to engage in various healthful lifestyle behaviors than the control~     participants after both participants listened to their respective health information.~   "
109413|NCT02135315|"~     The intensive arterial pressure control in acute coronary syndrome (ACS) during the first 24~     hours can improve the prognosis in the short and long term.~      We compare two treatment strategies (standard and intensive treatment) to assess their~     efficacy and safety in the treatment of acute coronary syndrome.~   "
109414|NCT02135302|"~     This is a multi-center, open-label clinical study to assess the single-dose PK of~     eravacycline in subjects with hepatic impairment and healthy subjects conducted at~     approximately 3 sites in the United States. This study includes an up to 21-day Screening~     Period, a 5-day Treatment Period, and an End of Study Visit occurring approximately 2 weeks~     (± 2 days) after initiation of study drug administration. Approximately 24 subjects will be~     enrolled: 18 subjects with impaired hepatic function (6 subjects who meet the criteria for~     each of the 3 Child-Pugh categories of mild [5 - 6 points], moderate [7 - 9 points], and~     severe [10 - 15 points]) and 6 healthy subjects without hepatic impairment. Healthy subjects~     will be matched to hepatically impaired subjects in gender, age, and body mass index (BMI).~     All subjects will be administered a single IV dose of eravacycline (1.5 mg/kg).~   "
109415|NCT02135289|"~     Hong Kong is a region of intermediate TB burden, and the reactivation of latent TB in IMID~     patients treated with anti-TNF can be a serious problem. This study aims to investigate the~     role of IGRA in screening for latent TB in IBD patients and control subjects. In part II of~     the study, patients of other immune-mediated inflammatory diseases (IMID) will also be~     included to investigate the role of serial interferon-gamma release assays (IGRA) for the~     diagnosis of tuberculosis (TB) infection in patients with immune-mediated inflammatory~     diseases (IMID) treated with biologics~   "
109416|NCT02135276|"~     This is a multi-center, open-label clinical study to assess the single-dose PK of~     eravacycline in subjects with renal impairment and healthy subjects conducted at~     approximately 2 sites in the United States. This study includes an up to 21-day Screening~     Period, a 5-day Treatment Period, and an End of Study Visit occurring approximately 2 weeks~     (±2 days) after study drug administration. Approximately 12 subjects will be enrolled: 6~     subjects with ESRD and 6 healthy subjects with normal renal function. Healthy subjects will~     be matched to renally impaired subjects in gender, age, and body mass index (BMI). All~     subjects will be administered a single IV dose of eravacycline (1.5 mg/kg).~   "
109417|NCT02135263|"~     The purpose of this study is to determine whether differences in the gene coding for the~     liver enzyme carboxylesterase 1 (CES1) means differences in the metabolism of two CES1~     dependent drugs, enalapril and methylphenidate.~   "
109418|NCT02135250|"~     This study aims to discuss whether the combined treatment of traditional Chinese medicine~     (TCM) and western medicine for Mental Stress Induced Myocardial Ischemia (MSIMI) does effect,~     namely the conventional therapy for Coronary Heart Disease( CHD) combining with TCM -~     Xinkeshu tablets.~   "
109419|NCT02135237|"~     Contingency management (CM) treatments are highly efficacious in improving outcomes of~     substance abusing patients. However, CM has rarely been applied to individuals with alcohol~     use disorders, primarily because of technological limitations in monitoring drinking. The~     Secure Continuous Remote Alcohol Monitor (SCRAMx®) is a new technology designed to~     continuously monitor alcohol consumption 24 hours a day for 7 days per week. The purpose of~     this study is to evaluate the efficacy of CM in reducing alcohol use using SCRAMx. In total,~     120 alcohol abusing or dependent patients initiating outpatient treatment at community-based~     clinics will be randomly assigned to one of two conditions: standard care, or standard care~     plus CM with reinforcement based on results of SCRAMx readings. Compared with standard care,~     it is expected that CM will result in fewer drinking days and longer durations of continuous~     non-drinking days.~   "
109420|NCT02135224|"~     The study hypothesis was that epidural fentanyl may accelerate the dilation of the cervix and~     possibly result in a shorter duration of vaginal delivery.~   "
109421|NCT02135211|"~     The objective of this proposal is to test the feasibility and acceptability of a lifestyle~     risk reduction intervention for patients with lung cancer receiving surgical treatment. This~     study will provide the preliminary data needed to conduct a larger randomized controlled~     trial that tests an innovative, multidisciplinary intervention that has the potential to~     transform the standard of care for patients receiving surgical treatment for lung cancer.~   "
109557|NCT02133430|"~     The purpose of this study is to compare the difference of incidence of postoperative delirium~     between patients received general anesthesia guided by Bispectral index (BIS) and patients~     received general anesthesia using standard technique.~   "
109422|NCT02135198|"~     GABA (gamma-aminobutyric acid) is the main inhibitory compound in the human brain. Drugs that~     enhance its effects by binding on GABA receptors (e.g., benzodiazepines) are used to treat~     various diseases such as epilepsy, insomnia, anxiety or movement disorders. However, the use~     of these medications is often compromised due to their side effects, like sedation, cognitive~     impairment, and addiction.~      Many of these side effects have been linked to a particular type of GABA receptor (GABA A~     alpha 1). Therefore, effort is being made to develop drugs that do not act on this receptor,~     but maintain their beneficial properties by acting on other types of GABA receptors. AZD7325~     is a drug that selectively acts on GABA A alpha 2 and A alpha 3 receptors, but not A alpha 1.~     It has been tested in more than 700 people and so far proved to be generally well tolerated.~     Positron emission tomography (PET) study in humans demonstrated that AZD7325 binds to GABA A~     receptors in the brain after a single dose. Early clinical studies have shown that it has~     less sedative and cognitive adverse events as compared with a benzodiazepine lorazepam.~      In this study, we will investigate its effects on short interval intracortical inhibition~     (SICI). SICI is neurophysiological marker of inhibitory processes in the motor cortex. It is~     obtained non-invasively by using transcranial magnetic stimulation (TMS). In TMS, magnetic~     impulses applied over the scalp that in turn induce a current in a small area of the brain.~     If applied over the motor areas of the brain, impulses result in muscle twitch that is~     recorded with surface electrodes. SICI is enhanced by certain drugs like benzodiazepines that~     act on GABA A alpha 1,2,3, and 5 receptor subtypes, but not by zolpidem acting solely on~     alpha 1 subtype. Because GABA A alpha 5 receptor subtype is less common in the cortex, it has~     been concluded that the drug effects on SICI are related to GABA A alpha 2 and alpha 3~     receptors.~      If AZD7325 proves to enhance SICI in healthy volunteers, this would create the grounds for~     the use of this medication to treat certain neurological disorders in which SICI has been~     found to be impaired (e.g., dystonia).~   "
109423|NCT02135185|"~     Improvement exercise tolerance~   "
109424|NCT02135172|"~     The number of people diagnosed with Type 2 diabetes (T2DM) is increasing rapidly and about~     2.9 million people in the UK currently have diabetes. There is increasing evidence suggesting~     that prolonged sedentary time may actually increase the risk of diabetes and other chronic~     diseases. Importantly, adults can meet public health guidelines on physical activity (150~     minutes of moderate activity per week), but if they still sit for prolonged periods, their~     metabolic health is compromised. Going from sitting to standing and carrying out~     light-intensity activities (such as casual walking) may reduce diabetes risk. However, no one~     has investigated the effect of standing and walking on markers of cardio-metabolic markers in~     individuals with a high risk of T2DM. Therefore, the aim is to find out whether reducing the~     amount of time people spend sitting and replacing it with standing and light intensity~     activity (walking) reduces glucose, insulin and triglyceride levels, therefore reducing the~     risk of diabetes.~   "
109425|NCT02135159|"~     The purpose of this study is to determine the optimal sequences of combined trastuzumab~     emtansine (T-DM1) and whole-brain radiotherapy in patients presenting brain metastases from~     HER2-positive breast cancer in terms of acute toxicities and blood/cerebrospinal fluid T-DM1~     pharmacokinetics.~   "
109426|NCT02135146|"~     The purpose of this study is to conduct a prospective, randomized, controlled trial comparing~     a restrictive vs. conservative fluid strategy in thoracic surgery patients. Excessive~     perioperative fluid has been retrospectively implicated in the development postoperative~     acute lung injury (PALI) and pulmonary edema following lung resection. However, fluid~     restriction in these patients is not without risk and may compromise end organ perfusion~     (i.e. acute kidney injury). The hypothesis is that a conservative fluid approach in thoracic~     surgery patients will result in better end organ perfusion with fewer occasions of acute~     kidney injury (AKI) without causing an increase in postoperative acute lung injury or~     pulmonary edema.~   "
109427|NCT02135133|"~     This research study is evaluating a combination of drugs called Ofatumumab and Idelalisib as~     a possible treatment for Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Leukemia~     (SLL).~      The main purpose of this study is to examine the combination of the two drugs, Ofatumumab and~     Idelalisib, in participants who have been diagnosed with CLL/SLL and have not previously~     received treatment but do require treatment. The investigators hope to observe how~     participants' disease will be impacted by this treatment and whether they will benefit more~     from combining these drugs together rather than taking them separately. Both of these drugs~     have been used in treatment for CLL / SLL and information from those research studies~     suggests that these drugs may help patients with CLL/SLL.~      Ofatumumab is an antibody engineered in the lab against CD20, a protein on the surface of CLL~     cells, which is expressed in CLL. An antibody is a molecule your body creates to identify~     foreign substances so that it can destroy them. Ofatumumab has been FDA approved for~     treatment of CLL/SLL that has relapsed or progressed on other therapies. Idelalisib is a drug~     that blocks one of the signals inside the cells that cause this type of cancer to grow and~     survive. The investigators hope that combining Ofatumumab with Idelalisib will stop the~     growth of disease.~      In this research study, the investigators are evaluating the side effects of combining these~     two drugs, gathering information on the CLL/SLL disease process and how the study affects the~     patient's cells, as well as assessing the outcome of the disease. This combination of drugs~     has been previously tested, and appeared to be well tolerated.~   "
109428|NCT02135120|"~     The purpose of this study is to determine whether intrathecal morphine (ITM) alone or its~     combination with peripheral nerve blocks (PNB) provides better analgesia for patients~     undergoing total knee arthroplasty (TKA).~   "
109429|NCT02135107|"~     The purpose of this study is to assess the efficacy and safety of E3810 10mg once and twice~     daily in maintenance therapy for PPI resistant gastroesophageal reflux disease patients.~   "
109430|NCT02135094|"~     The purpose of this study is to measure the effectiveness of a wearable therapeutic~     ultrasound device for relief of pain associated with the trapezius muscle of the upper back~     over a 4-week period. The trapezius muscle is a wide, flat, superficial muscle that covers~     most of the upper back and the posterior of the neck.The hypothesis is that the ultrasound~     device will lower the reported daily pain level of subjects suffering from trapezius muscle~     pain in their upper back.~      Subjects who participate in the study will self-administer the ultrasound device beginning at~     the onset of trapezius muscle pain, which is defined as a score of 3.0 or higher on a scale~     of 1-10. Subjects will be required to visit the clinical site at enrollment and weeks 2 and 4~     for a total of 3 visits. Subjects will report their daily pain levels in a diary.~      The wearable ultrasound device, Sam®, has been cleared by the FDA for pain relief, relief of~     joint contracture, relief of muscle spasm, and increased circulation.~   "
109431|NCT02135081|"~     This study seeks to determine cerebral blood flow changes in single ventricle patients during~     staged surgical reconstruction as compared with normal children. Two general groups of single~     ventricle patients will be recruited for this study, corresponding to the two approaches~     used. An aged-match group of healthy subjects will be included as a control.~   "
109433|NCT02135055|"~     ICU patients always experience all kinds of pain, discomfort and sleep disturbance,especially~     the sepsis patients. Appropriate sedation and analgesia is must,the newest sepsis guideline~     strongly recommend that mechanically ventilated sepsis patients need sedation therapy.~      Recent studies show than immune dysfunction dose have an important effect on the occurrence~     and development of sepsis. When the body suffer from the pathogenic microorganism attacking~     and sepsis, it activate the systemic inflammatory response (SIRS) and compensatory~     anti-inflammatory response syndrome (CARS). When it is out of balance between SIRS and CARS,~     the inflammatory response, immune paralysis or immune dysfunction occurs and the mixed~     anti-inflammatory response syndrome (MARS) exists, and then the multiple organ dysfunction.~     So, immune dysfunction is thought to be the key factors on the development of the sepsis.~     Some studies show that the sedation drug such as midazolam, propofol, dexmedetomidine could~     suppress the inflammatory response effectively and then modulate the immune function.~      Several recent studies show that midazolam has the immunoregulation effect and trend of~     suppress the inflammatory response, but the result is controversy, the possibly reason is the~     different immune status. Now there is the guideline about the different immune status: the~     normal immune function means that the value of mHLA-DR is more than 15000 monoclonal~     antibody; moderate-sever immune suppression means that the value of mHLA-DR is in the range~     of 5000 and 15000 monoclonal antibody; the immune paralysis means that the value of mHLA-DR~     is less than 5000 monoclonal antibody.~      The purpose of the study is to explore the effect of midazolam to inflammatory response and~     organ function at mechanically ventilated sepsis patients who have different immune status.~   "
109434|NCT02135042|"~     There are two study questions we are asking in this randomized phase II/III trial based on a~     blood biomarker, Epstein Barr virus (EBV) deoxyribonucleic acid (DNA) for locoregionally~     advanced non-metastatic nasopharyngeal cancer. All patients will first undergo standard~     concurrent chemotherapy and radiation therapy. When this standard treatment is completed, if~     there is no detectable EBV DNA in their plasma, then patients are randomized to either~     standard adjuvant cisplatin and fluorouracil chemotherapy or observation. If there is still~     detectable levels of plasma EBV DNA, patients will be randomized to standard cisplatin and~     fluorouracil chemotherapy versus gemcitabine and paclitaxel. Radiation therapy uses high~     energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin,~     fluorouracil, gemcitabine hydrochloride, and paclitaxel work in different ways to stop the~     growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. It is not yet known whether giving cisplatin and fluorouracil~     is more effective than gemcitabine hydrochloride and paclitaxel after radiation therapy in~     treating patients with nasopharyngeal cancer.~   "
109435|NCT02135029|"~     This study is a multicenter, double blinded, active and placebo controlled randomized~     clinical trial to demonstrate a superior lipid lowering effect of Bococizumab (PF-04950615;~     RN316) compared to placebo in subjects who are statin intolerant.~   "
109436|NCT02135016|"~     It is a prospective, randomized, placebo-controlled study to investigate the effect of TEA~     with different block level on propofol concentration during general anesthesia induction.~   "
109437|NCT02135003|"~     Hypothesis 1: The proportion of pre-ART patients whose CD4 cell counts decline to~     ART-eligibility within 48 weeks will be lower in intervention compared to the~     non-intervention arm.~      Hypothesis 2: PLHIV who receive the PSCB intervention will experience lower rates of~     morbidity or death over the follow-up period compared to patients not receiving the~     intervention~      Hypothesis 3: PLHIV who receive the PCSB intervention will have better adherence to scheduled~     clinic appointments compared to those not receiving the intervention~   "
109438|NCT02134990|"~     The study will be a prospective open-label single-center study in previously treated patients~     with Non Small Cell Lung Cancer (NSCLC). Treatment efficacy and safety of the combination of~     Oshadi D and Oshadi R with Docetaxel will be will be evaluated.~      Patients will receive Docetaxel in combination with Oshadi D and Oshadi R. Patient will be~     evaluated throughout the study for safety and tolerance to multiple dose regimens of Oshadi D~     and Oshadi R.~      CT or MRI imaging will be performed prior to treatment initiation and at the end of every 3~     Docetaxel cycles (12 weeks). In case of disease progression, dose augmentation will be~     considered or subsequent therapy.~   "
109439|NCT02134977|"~     The purpose of this survey is to examine the effect on quality of life (QOL) improvement and~     convenience of switching to leuprorelin acetate 3 months depot 11.25 milligram (mg) injection~     kit (Leuplin SR 11.25 mg injection kit) from a 4-week adjuvant therapy with a luteinizing~     hormone-releasing hormone analog (LH-RHa) 1 month depot over 48 weeks in premenopausal breast~     cancer participants in daily medical practice. Influence of condition of estrogen receptor~     expression on the efficacy and safety of leuprorelin acetate SR 11.25 mg injection kit was~     also evaluated.~   "
109440|NCT02134964|"~     This study is a randomized, placebo-controlled, sequential ascending-dose study of healthy~     volunteers after administration of single or multiple dose(s) of investigational drug~     (OLT1177 Caps or Placebo Caps). A total of 36 subjects will be enrolled across 6 cohorts, and~     subjects in each cohort will be randomized in a ratio of 5 active to 1 placebo.~   "
109441|NCT02134951|"~     The purpose of this study is to assess the relative feasibility of 2 potential functional~     measures of target engagement (Glx MRS, BOLD fMRI) to systematically assess mGluR 2/3 in drug~     development for psychotic spectrum disorders.~   "
109442|NCT02134938|"~     The purpose of this study is to assess whether low caloric, low energy density, konjac food~     products are effective in appetite regulation when administered as caloric replacements. It~     is hypothesized that replacement of typical, balanced, vegetarian meals with konjac food~     products will have comparable satiety scores, decreased postprandial glucose response, and~     will not significantly affect subsequent food intake.~   "
109443|NCT02134925|"~     This randomized phase II clinical trial studies how well MUC1 peptide-poly-ICLC adjuvant~     vaccine works in treating patients with newly diagnosed advanced colon polyps (adenomatous~     polyps). Adenomatous polyps are growths in the colon that may develop into colorectal cancer~     over time. Vaccines made from peptides may help the body build an effective immune response~     to kill polyp cells. MUC1 peptide-poly-ICLC adjuvant vaccine may also prevent the recurrence~     of adenomatous polyps and may prevent the development of colorectal cancer.~   "
109558|NCT02133417|"~     Conduct a case collection study of breast imaging examinations from women with~     mammographically-detected breast lesions for the purpose of conducting subsequent Reader~     Studies.~   "
109444|NCT02134912|"~     This randomized phase II trial studies how well pemetrexed disodium with or without~     crizotinib works in treating patients with stage IV non-small cell lung cancer that has~     progressed after crizotinib. Drugs used in chemotherapy, such as pemetrexed disodium, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Crizotinib may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known~     whether giving pemetrexed disodium is more effective with or without crizotinib in treating~     patients with non-small cell lung cancer that has progressed after crizotinib.~   "
109445|NCT02134899|"~     The investigators multicenter randomized open-labelled study will investigate the efficacy of~     an everolimus based immunosuppression in reducing total native kidney volume in kidney~     recipients with autosomal dominant polycystic kidney disease compared to a calcineurin~     inhibitor-based immunosuppression.~   "
109446|NCT02134886|"~     This phase I trial studies the side effects and best dose of erlotinib hydrochloride in~     treating non-small cell lung cancer that has spread to other parts of the body or cannot be~     removed by surgery in patients with human immunodeficiency virus (HIV) infection. Erlotinib~     hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth. Erlotinib hydrochloride is a standard drug used for treating lung cancer,~     however, it is not yet known whether it is safe to give erlotinib hydrochloride to patients~     who also have HIV infection or not.~   "
109447|NCT02134873|"~     Recent studies show that babies in hospital undergo an average of 4 to 5 painful procedures,~     such as heel lances, every day. Sucrose (sugar water) has been shown to be effective for~     reducing pain during invasive procedures and is a standard of care for painful procedures.~     The purpose of this study is to see what is the least amount of sucrose that can be given to~     a baby to reduce pain during procedures.~   "
109448|NCT02134860|"~     Bed rest produces insulin resistance in healthy volunteers. In this study the investigators~     aim to investigate the effect of 8 days bed rest on the incretin effect and how alternate~     daily fasting affects cognitive function and the insulin resistance produced by bed rest.~      The subjects will be randomized to either 3 meals a day (isocaloric diet), alternate daily~     fasting or one meal/day every second day (25% of daily calorie need) and four meals/day every~     second (175% of daily calorie need).~      The investigators hypothesize:~        1. Bed rest reduces the incretin effect~        2. Alternate daily fasting improves the cognitive function (memory and concentration)~          compared to isocaloric diet~        3. Alternate daily fasting reduces insulin resistance produced by bed rest compared to~          isocaloric diet~   "
109449|NCT02134847|"~     In this proposal, we seek to address conclusively two knowledge gaps: 1) the lack of data on~     the relationship between PGY2+ (post graduate year 2) sleep deprivation and patient safety;~     and 2) the lack of data on the relationship between resident sleep deprivation and~     preventable patient injuries. Through the Clinical and Translational Science Award~     (CTSA)-funded Sleep Research Network, the largest and only federally-funded sleep science~     network in the U.S., we propose conducting a multi-center randomized crossover trial in six~     pediatric ICUs staffed by PGY2 and PGY3 residents. We will compare rates of all serious~     errors (i.e., rates of harmful and other serious medical errors due to any cause, including~     but not limited to fatigue-related errors, handoff errors, and provider knowledge deficits)~     of a sleep and circadian science-based (SCS) intervention schedule with a traditional~     schedule that includes frequent shifts of 24 hours or longer. Our specific aims will be:~        1. To test the hypothesis that PGY2&3 residents working on an SCS intervention schedule~          will make significantly fewer harmful medical errors (preventable adverse events) and~          other serious medical errors (near misses) while caring for ICU patients than residents~          working on a traditional schedule; (primary endpoints: resident-related preventable~          adverse events and near misses)~        2. To test the hypothesis that rates of harmful medical errors (preventable adverse events)~          and other serious medical errors (near misses) throughout the ICU (i.e., those involving~          and those not involving residents) will be lower in ICUs when PGY2&3 residents work on~          an SCS intervention schedule than when residents work on a traditional schedule; (major~          secondary endpoints: ICU-wide preventable adverse events and near misses)~        3. To test the hypothesis that resident physicians' risk of neurobehavioral performance~          failures and motor vehicle crashes - as assessed through simple visual reaction time~          tasks [Johns Drowsiness Score (JDS) and Psychomotor Vigilance Task (PVT) lapses] - will~          be lower on the SCS intervention schedule than on the traditional schedule. (major~          secondary endpoints: resident neurobehavioral performance and predicted driving safety)~   "
109450|NCT02134834|"~     The objectives of this study are to assess the safety, tolerability and pharmacokinetic~     profile of OP0595 administered intravenously to healthy male, Caucasian, adult subjects at~     single escalating doses.~   "
109451|NCT02134821|"~     Pain sensitivity would be associated with surgical outcomes after lumbar spine surgery.~   "
109452|NCT02134808|"~     The primary hypothesis is that compared to placebo, 10g of daily creatine monohydrate for~     eight weeks will be associated with significant increases in frontal lobe phosphocreatine and~     beta-nucleoside triphosphate (β-NTP) concentrations. A secondary hypothesis is that decreased~     depressive symptoms measured with the Children's Depression Rating Scale-Revised (CDRS-R) and~     Montgomery-Asberg Depression Rating Scale (MADRS) will be reciprocally correlated with~     increased β-NTP concentrations.~   "
109453|NCT02134795|"~     This is a single-center, unblinded trial without placebo control to evaluate the acute~     effects of caloric vestibular stimulation on UPDRS motor scores in Parkinson's Disease~     patients.~   "
109454|NCT02134782|"~     Fatigue is a major problem in children, adolescents and adults receiving intensive~     chemotherapy for cancer and in patients undergoing hematopoietic stem cell transplantation~     (HSCT). Guidelines from the National Comprehensive Cancer Network suggest that all patients,~     including children as young as 5 years of age, should be routinely screened for fatigue at~     the initial visit and at regular intervals throughout and following anti-cancer treatment.~     These guidelines also suggest that fatigue should be managed according to clinical practice~     guidelines. However, evidence demonstrating effective interventions for fatigue in children~     with cancer is scarce. Exercise is an effective intervention for cancer-related fatigue in~     patients of all ages. However, patients receiving the most intensive treatments may be too~     ill to participate in a standardized exercise program. A unique and potentially effective~     intervention that combines exercise and relaxation is yoga. This randomized controlled trial~     (RCT) will determine whether a 3 week program of individualized yoga is associated with less~     fatigue, better quality of life (QoL) and less systemic opioid use compared to the control~     program of an Apple tablet (iPad) games, music, movies or books. This is a single-site,~     parallel-group, randomized trial of individualized yoga for fatigue. Subjects are inpatients~     8-18 years of age receiving intensive chemotherapy for cancer or undergoing HSCT who are~     expected to remain in hospital for 3 weeks. Participants will be randomized to the~     individualized yoga program or to the iPad activity control program. For those who remain~     hospitalized on day 21, the alternate intervention will be offered for 1 week and the~     preferred strategy will be determined. Yoga has the potential to significantly reduce~     fatigue, a prevalent and distressing symptom, in children with cancer and HSCT. The~     investigators have assembled the optimal team with the expertise and track record to~     accomplish this important trial. This trial is an incremental and critically important step~     in a program of research designed to improve health for children at the highest risk for poor~     quality of life. Results may have broad applicability to other hospitalized pediatric~     populations and has the potential to change in-hospital care for these patients.~   "
109559|NCT02133404|"~     To examine efficacy and safety after 12-week administration of ASP7991 in secondary~     hyperparathyroidism patients undergoing hemodialysis~   "
125597|NCT01923493|"~     The aim is to evaluate whether tuina is more effective and cost-effective than no~     intervention waiting list to reduce neck pain measured on a visual analogue scale in patients~     suffering from chronic neck pain.~   "
109457|NCT02134743|"~     The aim of this study is to compare the stability of dental implant surface treated by~     sandblasting abrasive particles and acid subtraction (Control) with hydrophilic surfaces~     dental implants (chemical) and with a higher surface energy (Test) for a period of 16 weeks~     after installation. The evaluation will be made by analyzing the resonance frequency~     (Ostell). The hypothesis to be tested will be that implants with hydrophilic surface show~     increased secondary stability prior to the implants treated by acid etching.~   "
109458|NCT02134730|"~     Mental illness is a major health problem in children and young people, and there is evidence~     that mental illness is increasing among young people in the population. More than 80 % of the~     cost to society of mental illness in children in Sweden is the cost of treatment and care.~      Anxiety and depression are the most common psychiatric problems in children and adolescents.~      In comparison with the treatment of mental disorders, there is relatively limited knowledge~     about prevention. There are at least two very important reasons to investigate further~     preventive interventions for anxiety and depression. (1) Only about 20% of children and~     adolescents with anxiety or depression use health services. (2) Some children stop treatment~     and almost 40% do still fulfill criteria for the disorder after treatment.~      FRIENDS for life is one of the most evaluated prevention programs internationally. The~     program has shown promising results in research. The overall aim of the present study is to~     evaluate FRIENDS for Life in Sweden.~   "
109459|NCT02134717|"~     The study hypothesizes that inhibition of the receptor CCR5 by maraviroc will diminish~     inflammation in patients with sarcoidosis. Subjects with active sarcoidosis will first~     undergo bronchoscopy with bronchoalveolar lavage to recover lung immune cells for baseline~     analysis. They will then receive the drug maraviroc for 6 weeks duration. They will then~     undergo a repeat bronchoscopy with bronchoalveolar lavage to recover lung immune cells for~     analysis following maraviroc treatment.~   "
109460|NCT02134704|"~     The hypothesis of this study is that moderate scoliosis patients have postural and kinematic~     differences (static and dynamic) compared with healthy volunteers and it is possible to~     characterize and quantify.~      The aim of this study is the detailed analysis of postural anomalies in moderate scoliosis~     patients compared with healthy volunteers~   "
109461|NCT02134691|"~     This project will examine the impact of PE therapy for the treatment of PTSD with a sample of~     Latinos. The need to provide effective treatment to Spanish-speaking Latinos with PTSD is~     critical given the high prevalence of PTSD among Latinos. Furthermore, PTSD remains an under~     detected and under treated condition. Untreated PTSD has a substantial impact on health,~     functioning and quality of life. PE is one of the most empirically supported psychological~     interventions for PTSD. However, most studies that evidence the efficacy of PE have been~     conducted mainly with English-speaking Caucasian populations. This study has the potential to~     contribute to improvements in the well-being of Spanish-speaking Latinos with PTSD.~   "
109462|NCT02134678|"~     This study will compare mechanisms of action in two forms of brief psychotherapy for major~     depressive disorder in adults. A treatment that targets deficits in motivation in depression~     is expected to show greater improvements in motivation and pursuit of personal goals compared~     to a second treatment that targets irrational thoughts that are typical in depression.~   "
109463|NCT02134665|"~     The purpose of this study was to evaluate the influence of severe acute pancreatitis on the~     serum level of vancomycin, a glycopeptide antibacterial agent.~   "
109464|NCT02134652|"~     The purpose of this study is determine the ability of bedide ultrasound performed in the~     Emergency Department and Outpatient Department can predict the severity of disease during a~     Dengue Fever outbreak in children, in Siem Reap, Cambodia. Our hypothesis is that the~     presence of gallbladder wall thickening and/or pleural effusions in children correlates with~     progression to Dengue hemorrhagic fever and Dengue shock. In addition, we hypothesize that~     sonographic imaging of pediatric patients presenting to the emergency department with a fever~     during a Dengue fever outbreak will change management and disposition.~   "
109465|NCT02134639|"~     Through the investigators involvement in an international consortium, the investigators had~     the opportunity to acquire a new type of synthetizer for the radiolabelling of such tracers.~     The investigators propose in this project to develop on their site, the radiosynthesis of~     68Ga-DOTATOC and to evaluate prospectively the diagnosis of neuroendocrine tumors, compared~     with the current imaging OctreoScan®. The objectives of this project are: - to validate the~     radiosynthesis of 68Ga-DOTATOC on their site with a new synthetizer - and clinically~     evaluate, through a prospective preliminary study, the diagnostic accuracy of PET-CT with~     68Ga-DOTATOC in comparison with other standard imaging examinations.~   "
109466|NCT02134626|"~     It´s a clinical research of the effects in portal hypertension caused by simvastatin. We are~     going to use the hepatic venous pressure gradient(HVPG) measurement and the azygos flow at~     echoendoscopy to evaluate the benefits of the drug. Preliminary studies demonstrated that~     simvastatin can lower portal pressure.~   "
109467|NCT02134613|"~     Rheumatoid and psoriatic arthritis patients benefit from anti-TNF-α therapy, once it is~     effective in reducing joint and skin manifestations in 60-70% of patients with inflammatory~     articular joint and skin diseases. Thus, identifying the presence and amount of TNF-α in the~     joint or skin in these patients may help in guiding the course of treatment more efficiently.~     The investigators research group has developed a novel approach to label anti-TNF-α with~     technetium-99m. Here the investigators compare the results obtained with scintigraphy and MRI~     in rheumatoid and psoriatic arthritis. The 99mTc-anti-TNF-α scintigraphy might recognize the~     molecule involved in the inflammatory process and provide crucial information to help~     physicians taking decisions about the drugs to be used based on biological evidence and which~     are cost-effective and appropriate for the treatment of choice. It allows direct~     identification of the monoclonal antibody anti-TNF-α in the articular joints and skin while~     it also ensures that the drug has reached its therapeutic target. It also allows correlation~     between the presence of the drug and clinical responses.~   "
109468|NCT02134600|"~     The purpose of this study is to find an optimal dose of omega-3 that can be given to children~     who have completed cancer therapy. The future aim is to add omega-3 to conventional cancer~     treatment modalities and thereby hopefully increase the treatment efficacy, which will have~     to be addressed in subsequent phase-2 studies.~   "
139401|NCT01742676|"~     The purpose of this study is to evaluate and compare the safety and efficacy of two drugs~     (ADVAGRAF® and PROGRAF® groups) in patients who received renal transplantation.~   "
109469|NCT02134587|"~     Spontaneous reports by health professionals generate the signals in pharmacovigilance.~     However, the passive method has limitations and the most important of them are the~     underreporting and the poor quality of data, hindering the causality assessment of adverse~     drug events (ADE). Therefore, the present study aimed to validate an educational intervention~     (EI) in pharmacovigilance for hospital health professionals, in order to analyze the impact~     on the knowledge, skill and attitude in ADE reporting.~      Investigators proposed a multifaceted EI which will be developed in four meetings with one~     hour each. The following activities will be carried out: application of a questionnaire to~     assess the knowledge, skill and attitude before and after EI; lecture; practical class and~     education material distribution. The answers of questionnaire are going to be analyzed using~     content analysis technique. The definitions of World Health Organization and the minimum and~     desired criteria to fill the ADE form, according to the Pan American Health Organization, are~     going to be considered gold-standard answers. The statistical test of Wilcoxon-Mann Whitney~     test for paired samples will be applied, in order to assess the impact of educational~     intervention on behavior of health professionals (ADE reporting).~      With the present study, the following hypotheses will be tested:~      H0= There is no difference between the numbers of ADE reported (behavior/attitudes) before~     and after the educational intervention.~      H1= The numbers of ADE reported before and after the educational intervention are different.~   "
109470|NCT02134574|"~     Prospective Cohort Study of clinical and laboratory data of patients with hemopathy.~   "
109471|NCT02134561|"~     The purpose of this study is to assess the psychological, cognitive and social resources of~     applicants for Huntington's Disease and Presymptomatic Testing.~   "
109472|NCT02134548|"~     This study is a multi-site trial assessing the sensitivity of Chagas Detect™ Plus rapid test~     versus standard reference tests (e.g. IFA, IHA, RIPA) for Chagas diagnosis.~      The Chagas Detect™ Plus rapid test serves as an aid in the clinical laboratory diagnosis of~     Chagas infection in patients. This test is intended to be used on human whole blood or serum~     samples. Chagas Detect™ Plus results (positive or negative) must be confirmed by testing with~     a reference standard test.~      Subjects will be patients at clinical sites located in Chagas-endemic areas. After informed~     consent is obtained and the subject is screened for eligibility, 2 diagnostic samples will be~     collected. One is blood from finger prick, and the other is blood from venous puncture (drawn~     from vein in arm).~      Rapid tests and reference tests will be performed by different operators who are laboratory~     staff members. These staff members, blinded to each other's results, will evaluate the~     samples from each method independently.~   "
109473|NCT02134535|"~     The overall purpose of this research study is to collect vaginal and cervical biopsies from~     healthy HIV negative participants. These samples will enable investigators to optimize~     laboratory methods and explore implementation challenges associated with the ex vivo~     challenge model. The first objective is to assess which HIV virus is best for use in the~     model. The second objective is to determine the best endpoint for the assay.~      The primary aim of this study is to collect an adequate number of cervical and vaginal~     biopsies to support the optimization of an ex vivo challenge model. This ex vivo challenge~     model has been and will continue to be used in topical microbicide clinical trials to predict~     the efficacy of candidate drugs.~   "
109474|NCT02134522|"~     The purpose of this study is to examine whether CPAP therapy can reduce or eliminate hepatic~     fat accumulation in obese children and adolescents.~   "
109475|NCT02134509|"~     The purpose of this study is to test the effectiveness of a smartphone application for~     smoking cessation in smokers ages 18 to 65 years.~   "
109476|NCT02134496|"~     The study investigates the safety of discharge from the Post-Anesthesia Care Unit (PACU)~     without assessment of motorfunction after spinal anesthesia for total hip- or knee~     replacement. This is an randomized controlled trial between two groups with assessment of~     normal (Aldrete) PACU discharge criteria with or without assessment of the motorfunction. The~     study hypothesis is that it is safe to be discharged from the PACU to a ward without~     assessment of motor function.~      The main outcome is length of hospial stay (LOS) in days and re-admission within the first 30~     days after surgery .~      Secondary outcomes include adverse events up to 24 hours after surgery, and minuttes spent in~     the PACU after surgery.~      Participants will be monitores for adverse events for the first 24 hours after surgery and~     reported. The total number of minuttes spent in the PACU will be recorded and reported.~   "
109477|NCT02134483|"~     Parathyroid allo-transplantation (PA-t) is a valuable alternative in the treatment of~     permanent hypoparathyroidism. However, it is a difficult process that requires a number of~     trained staff and advanced laboratory equipment which bring high costs. In this study, we~     have identified a new PA-t technique.~   "
109478|NCT02134470|"~     It is generally accepted that chemical testing of biologic fluids is the most objective means~     of diagnosis of drug use. In recent years saliva has attracted much attention. The prime~     advantage of saliva is that it offers non-invasive, stress-free and real-time repeated~     sampling whereas blood collection is undesirable, difficult and expensive. In addition, it is~     known that androgens such as testosterone can be assayed in saliva, as these steroids pass~     the endothelial-epithelial barriers by passive diffusion. Nevertheless, the correlations of~     blood, urine and saliva concentrations are not well documented. In recent reviews, it is~     pointed out that salivary hormone analysis could be a promising method for sports medicine~     and doping control, but much work is needed before the use of saliva samples in this area~     receives the acceptance. According to recent studies the increase of testosterone~     concentration in saliva is significantly higher than alterations of steroid concentrations~     (or ratios) in blood or urine. Saliva concentration may therefore serve as screening~     parameter to select suspicious cases for further target evaluation (e.g. by IRMS). This may~     be beneficial to identify cases of transdermal administration of low steroid doses. It is~     therefore the aim of the present project to detect administered testosterone in saliva and~     compare these levels to those in blood and urine. The intention is not to detect high dosage~     but low dosage abuse of testosterone, as a single-dose by patch application. From the~     practical point of view saliva could offer a complementary specimen for a pre-screening of~     testosterone. So it could be assumed that salivary testosterone exceed upon plasma and/or~     urine levels. So the present study could be the base for a new method to preselect the~     suspicious samples for testosterone abuse.~   "
109479|NCT02134457|"~     This study is designed as an exploratory study to assess safety and efficacy of two different~     doses of the anti-VEGF agent ranibizumab (0.12 mg vs. 0.20 mg) in the treatment of infants~     with retinopathy of prematurity. Furthermore it shall help to improve safety in the treatment~     of ROP and provide explorative data on long-term effects of ranibizumab after intravitreal~     injection in neonates.~      The primary objective is to assess clinical efficacy of ranibizumab in children with ROP~   "
109480|NCT02134444|"~     Study Description and Purpose:~      The vestibular sense organs of the inner ear consist of the semi-circular canals and otolith~     end organs. These organs contain specialized gravito-inertial sensors that sense angular and~     linear head acceleration. The input from these sensors is required to stabilize gaze position~     during head motion, and provide an absolute frame of reference with respect to gravity, thus~     providing a vertical spatial reference for body orientation and balance. Disease or damage of~     the vestibular sense organs causes a range of distressing symptoms and functional problems~     for people that could include loss of balance, gaze instability, disorientation and~     dizziness. A novel computer based rehabilitation system with therapeutic gaming application~     has been developed. This method allows different gaze and head movement exercises to be~     coupled to a wide range of inexpensive, commercial computer games. It can be used in standing~     and thus graded balance demands using a sponge pad can be incorporated into the program.~      Study Objective:~        1. Test the therapeutic effectiveness of the TRP delivered in the home compared to usual~          care delivered in an out-patient physical therapy clinic on measures of balance~          (standing and walking) , gaze control, dizziness, and health related quality of life in~          individuals with peripheral vestibular disorders.~        2. Compare trajectory of change in electronic gaze performance measures obtained during~          each therapy session of each participant assigned to the home Telerehabilitation.~      Hypothesis:~      Investigators believe the Telerehabilitation platform to be a cost-effective delivery of~     rehabilitation. Additionally motivation to perform tedious home programs can be improved with~     engaging, fun and interactive computer gaming as part of the rehabilitation process. It is~     hypothesized the home game-based Telerehabilitation program will result in greater~     improvements in dynamic balance control, gaze control, and dizziness, in individuals with~     peripheral vestibular disorders as compared to a typical out-patient physical therapy~     regimen.~   "
109481|NCT02134431|"~     Microbicides are topical medicines that can prevent infection by Human Immunodeficiency Virus~     (HIV). Microbicide medicine has yet to be studied in adolescents, a key group that is~     becoming infected with HIV all over the world. From past research, we know that at different~     ages people experience age-related changes in their bodies that can cause differences in how~     they process medications. In this study, gut tissue samples (or gut biopsies) from 12~     HIV-negative volunteers will be collected. These pieces of tissue will be infected with HIV~     in the laboratory to develop a model that can be used to test certain drugs against the HIV~     infection. We can use this tissue to test a drug called tenofovir against HIV infection. We~     will determine whether this drug can decrease HIV infection in the gut biopsies. In this~     study, we will also measure HIV levels and the levels of tenofovir in gut and blood samples~     in 12 people who are already taking this drug. This information can determine whether levels~     of drug found in the gut can protect it from HIV. The results can be compared to other age~     groups of adolescents and adults. Subjects will undergo a common procedure called a lower~     endoscopy (this can be a colonoscopy or a flexible sigmoidoscopy) to obtain gut biopsy~     samples.~      The central hypothesis is that tissue drug profiles of tenofovir (TFV) and its active~     component, tenofovir disoproxil fumarate (TDF), and tissue infectibility vary between younger~     (10-14 years old) versus older adolescents (18-21 years old), and that both differ from~     adults (>21 years). Specifically, younger HIV positive adolescents will have lower levels of~     tissue tenofovir compared to older HIV positive adolescents and adults in an age-dependent~     manner. Additionally, biopsies from younger HIV negative adolescents will have: 1) higher~     rates of infection compared to biopsies from older HIV negative adolescents infected with a~     lower dose of virus; and 2) lower percent suppression of tissue infectivity compared to~     biopsies from older HIV negative adolescents using low dose tenofovir.~   "
109482|NCT02134418|"~     Intervention aimed at improving understanding of irony in social situations by using movies~     and comic strip will improve theory of mind.~   "
109483|NCT02134405|"~     This is a multi-Asian-centre randomised controlled trial of Rebamipide alone vs Rebamipide~     with Esomeprazole in the treatment of adult patients with Functional Dyspepsia. The~     hypothesis is that a combination therapy is superior to mono-therapy in the control of~     patients' symptoms and quality of life improvement.~   "
109484|NCT02134392|"~     C-diff infection often causes belly pain and diarrhea and can be very hard to treat with~     medicine. One of the possible reasons that C-diff infection is hard to treat is because there~     is too much bad bacteria in the colon. Investigators believe that putting more good~     bacteria into the colon will help fight the bad bacteria. We do this by doing a fecal~     (poop) transplant.~      Fecal transplant has been done at other hospitals, but not at Nationwide Children's Hospital.~     Since our Investigators have not done this before, this study will help us learn the best way~     to do the transplant. Investigators also believe this transplant might help improve symptoms~     for patients with C-diff.~   "
109485|NCT02134379|"~     This pilot study proposes to perform measurements of approved thoracic impedance technology~     that will help answer questions in patients with decompensated heart failure.~   "
109486|NCT02134366|"~     The purpose of this study is to evaluate whether clobazam, brand name Onf®, is more effective~     as an adjunctive or monotherapy in terminating Epilepsia Partialis Continua (EPC) than either~     lorazepam and/or clonazepam.~   "
109487|NCT02134353|"~     This trial aims to provide prospective evidence of the safety and efficacy of mannitol 400 mg~     b.i.d. in subjects aged 18 years and above.~      We hypothesize that inhaled mannitol 400 mg b.i.d. will increase the mean change from~     baseline FEV1 (mL) compared to control over the 26-week treatment period in adult subjects~     with cystic fibrosis. Any improvement in FEV1 is considered clinically meaningful, however,~     this trial has set a threshold of 80 mL for the purposes of determining an appropriate sample~     size for statistical power while retaining trial feasibility in an orphan disease population~   "
109488|NCT02134340|"~     The purpose of the study is to evaluate the safety and biodistribution of [I-124]-CPD-1028~     Injection in cancer patients with solid tumours.~   "
109489|NCT02134327|"~     Following an obtained written consent, a child presenting for ear tube surgery will be~     randomized into one of three groups for receiving a premedication. One group will be the~     current therapy with midazolam, another group will be another drug dexmedetomidine, and the~     third group will be a combination of midazolam plus dexmedetomidine. Observers in the study~     (the investigators fellow and advance practice nurse) will not know which group each patient~     belongs, and will then make three separate assessments: preoperative sedation, mask~     acceptance, and postoperative delirium.~      Mask acceptance: Induction of anesthesia, or the beginning of the process for the patient to~     fall asleep and lose consciousness, involves placing a mask over there face, specifically the~     nose and mouth. The mask is connected to their anesthesia machine via tubing, or a circuit,~     through which their anesthetic gases flow. Some children fight the mask as it can be seen as~     new and frightening. Other children, sometimes depending on how sedated they are after~     receiving a premedication, do not fear the mask on their face and do not resist induction.~     How well or easily this happens can be described as mask acceptance. Postoperative delirium~     can be seen in patients of any age or after any surgery and can be better defined as a mental~     disturbance during the recovery from general anesthesia consisting of hallucinations,~     delusions, and confusion manifested by moaning, restlessness, involuntary physical activity,~     and thrashing about in bed. It has been considered a common postanesthetic problem in~     children and adults since 1960.~      Each patient will then have a set of numbers for each scale; following conclusion of the~     study the investigators will be able see which drug each patient received and statistical~     analysis can be completed. The investigators goal is to see if there is any difference in any~     of the scales depending which medication was administered. The scales to be utilized include~     the pre-operative sedation scale, the mask acceptance scale, and the pediatric emergence~     delirium scale.~   "
112722|NCT02091999|"~     The purpose of this study is to evaluate the safety and pharmacokinetics of enfortumab~     vedotin as well as assess the immunogenicity and antitumor activity in subjects with~     metastatic urothelial cancer and other malignant solid tumors that express Nectin-4.~   "
109490|NCT02134314|"~     The use of C1INH (Berinert) in patients receiving deceased donor kidney transplants with high~     risk for delayed graft function (DGF) may show significant improvement in outcomes post~     transplant compared with patients that do not receive C1INH treatment. Complement activation~     has been detected in animal models and human kidneys with ischemic reperfusion injury (IRI)~     and inflammatory cell infiltrates. By blocking complement activation the investigators hope~     to improve kidney graft function post transplant in these recipients.~   "
109491|NCT02134301|"~     The purpose of this Phase 1 trial is to evaluate the pharmacokinetics, safety and~     tolerability of oritavancin in patients <18 years old with a confirmed or suspected bacterial~     infection.~   "
109492|NCT02134288|"~     Currently looking for individuals that have received a kidney transplant, are experiencing~     delayed graft function (DGF), and meet the criteria for study participation.~   "
109493|NCT02134275|"~     The purpose of this study is to evaluate the benefits and feasibility of a whole body~     vibration (WBV) exercise program as a method of preventing weight gain in young adults.~   "
109494|NCT02134262|"~     The purpose of this study is to evaluate the safety, efficacy and blood kinetics of~     autologous T cells genetically modified to express anti-CD19 Chimeric Antigen Receptor in~     patients with relapsed or refractory B-Cell Non-Hodgkin Lymphoma.~   "
109495|NCT02134249|"~     The purpose of this study is to compare the effect of oral Diosmin to oral Cabergoline in the~     prevention of ovarian hyperstimulation syndrome (OHSS) in high-risk women underwent~     intracytoplasmic sperm injection (ICSI).~   "
109496|NCT02134223|"~     Borderline personality disorder (BPD) is a chronic and debilitating syndrome associated with~     considerable morbidity, mortality, and high rates of medical and psychiatric utilization~     services. Research focusing on finding a biological observable marker for the purpose of~     monitoring treatment effects has started to draw attention. Recent research has implicated~     that brain-derived neutrophilic factor (BDNF) might be a natural candidate for a biological~     correlate of early life stress. The alterations in levels of BDNF or BDNF methylation in BPD~     patients compared to general population, or pre- and post- psychotherapeutic treatment might~     indicate the consequence of epigenetic modification associated with stressful experience or~     suicide, and may later be able to explain the psychopathology or neuro-development of BPD.~      Method: The investigators therefore propose this current randomized control trial to test~     whether epigenetic changes happen during and after DBT treatments, and not TAU. Proportions~     having suicide or non-suicidal self injurious behaviors will be followed and tested against~     changes in BDNF methylation levels. Other clinical symptoms will as be assessed, including~     suicidality, depression, hopelessness, quality of life, disability, service utilization, and~     function.~      In the first to third years of this study, the investigators will aim to recruit 180 study~     and control subjects, to gather information, to collect biological samples, to give out~     one-year of psychotherapy per subject, to evaluate results before, during, and after~     treatment. In addition, the investigators also hope to explore the effects of known or~     unknown drugs associated with the change of DNA methylation at cell level.~      Hypothesis:~      Responders of participants who receive DBT will show greater decrease in BDNF methylation~     levels than patients receiving TAU.~   "
109497|NCT02134210|"~     This is a two part study comparing CHS-0214 to Enbrel in patients with chronic plaque PsO who~     have not yet received any biologic therapy for any indication (other than insulin or~     hormones).~   "
109498|NCT02134197|"~     The purpose of this study is to evaluate:~        -  The side effects of BAY1129980 when given every 21 days different dose levels.~        -  Determine the dose level of BAY1129980 that should be tested in future clinical research~          studies.~        -  Measure how much BAY1129980 is in the blood at specific times after administration.~        -  If treatment with BAY1129980 shows any effect on reducing the tumor growth.~        -  If there are specific biomarkers that might be able to explain why some patients respond~          to treatment and others do not.~        -  If treatment with BAY1129980 causes an immune response from the body against the drug~          (immunogenicity).~   "
109499|NCT02134184|"~     In this study we are trying to understand whether previous infection with a particular virus,~     namely cytomegalovirus (CMV), influences the ability of the immune system to respond to new~     infections or vaccinations with age.~   "
109500|NCT02134171|"~     The aim of this study is to determine the frequency of cardiac and cerebral involvements in~     patients with idiopathic thrombotic microangiopathies on diagnosis. Patients will be assessed~     for cardiac involvement (troponin Ic level and cardiac ultrasonography) and cerebral~     involvement (cerebral MRI). The investigators will assess whether serum troponin Ic on~     diagnosis can predict morbidity and mortality of patients with a thrombotic microangiopathy~     at the acute phase.~      The primary outcome measurement is the event free survival at day 30, as defined by death,~     myocardial ischemia, arrhythmia, severe cerebral injury and disease exacerbation. An increase~     in troponin Ic on diagnosis is defined as at least one result above 0.2 ng/ml among the three~     daily analyses performed after TMA diagnosis.~   "
109501|NCT02134158|"~     The aim of this trial is to quantify the improvement of locomotion and equilibrium induced~     par tDCS in anode polarity position in post stroke hemiplegic patients.~   "
109502|NCT02134145|"~     There is a great need within healthcare to develop systems of care that better engage and~     activate people in their own care before they become patients. By so doing lay users will be~     empowered to take charge of their own care in recognizing they can change their health and~     improve their quality of life. Mobile health technologies such as the Scanadu ScoutTM hold~     the potential to truly engage individuals in the way needed through real-time data capture,~     transmission and connectivity.~      We propose to evaluate the real-world use of the Scanadu ScoutTM by a cohort of self-selected~     investors in an earlier crowdfunding campaign on Indiegogo for the Scanadu Scout™, through a~     prospective observational study. Using validated survey tools and through the remote tracking~     of frequency of use and physiological measurements from the Scanadu Scout™ device and app.~      Participants will receive web-based surveys at 4 time points: baseline, 3, 12 and 18 months.~      Participants will be instructed to use the Scanadu Scout™ as much as they would like. The~     parameters that will be functional on the device and available for measurement by the~     participant are:~        -  Heart rate~        -  Respiratory rate~        -  Temperature~        -  Oxygen saturation~        -  Heart rate variability~        -  Blood pressure~      Data analysis will examine individual participant and aggregate level:~        1. Usage and physiologic measurement data of the device,~        2. Perceptions of the device, and~        3. Changes in self-reported health self-management, health-related quality of life,~          participant- physician communication and medication adherence between baseline and~          follow-up.~   "
110067|NCT02126761|"~     In this study, the safety and immunogenicity of the current formulation of aTIV will be~     compared to aTIV-modified formulations in which the dosage of the MF59 adjuvant will be~     doubled or tripled and/or the dosage of the 3 influenza virus strains will be doubled, in~     independently-living elderly subjects ≥ 65 years of age.~   "
109503|NCT02134132|"~     Diabetes is a multiorgan disease and considered a major health problem in different~     societies. One of the complications the pain particularly in the extremities resulting from a~     process known as diabetic foot ulcer. The diabetic patients are subjected to many~     complications because of foot ulcers, many of them like as chronic wound disease or pressure~     ulcers (bed sore). Routinely used medical measures for diabetic foot ulcers are depended to~     nursing care and take too long until pain relief. Among many tested materials and works for~     wound healing such as debridement, tissue oxygenation, and skin transplantation,~     platelet-derived compounds are allocated the pivotal position between investigators to tissue~     regeneration and shortening the wound healing process.~      Many of platelet components are procured from platelet rich plasma (PRP) from whole blood~     donation. Furthermore, it requires to an additional purification step to diminish the volume~     and facilitate handling in some studies. It means that platelet concentrates (PCs) may be~     obtained leading to more concentrated platelets in lower volume.~      Two types of granules in platelet is responsible for storage of many useful and different~     growth factors: dense or delta and alpha granules. Platelet-derived growth factors have the~     ability to growth and differentiation of numerous cells. Also, the antibacterial effect of~     these growth factors has been reported.~      To better efficacy and comfortable utilization of platelet, it is feasible to form the~     platelet gel and then apply on wound sites.~      This study is a double blind randomized controlled trial to evaluate the positive effects of~     umbilical cord blood-derived platelet gel in 244 patients with diabetic foot ulcers.~   "
109504|NCT02134119|"~     The purpose of this study was three-fold. We wanted to (1) determine if supplementation with~     an echinacea-based dietary supplement (ECH) would increase several blood parameters that~     could affect oxygen carrying capacity in the body, (2) determine if ECH would increase VO2max~     in trained endurance athletes, and (3) examine the effectiveness of two different doses of~     the ECH on all outcome variables. We hypothesized that supplementation with ECH would~     increase oxygen carrying capacity (as measured by RBCs, EPO, ferritin, hemoglobin (Hb), and~     hematocrit (Hct) levels), improve VO2max, and that the maximum dose would be most effective~     at increasing these outcomes.~   "
109505|NCT02134106|"~     Background and rationale:~      Antimicrobial resistance is a global public health threat. An increasing number of~     Gram-negative bacteria isolates worldwide are resistant to virtually all antibiotics~     including carbapenems. Although polymyxins are the current gold standard antibiotic for~     treatment of severe extensively drug-resistant Gram-negative bacteria (XDR-GNB - defined in~     Appendix I) infections, resistance development on therapy and treatment failures are common.~     Combination antibiotics therapy have better in vitro efficacy, but have not been formally~     tested in a prospective trial.~      We will conduct a Phase IIB, prospective, open-label, randomized-controlled trial in 4 major~     Singaporean hospitals, with balanced treatment assignments achieved by permuted block~     randomization, stratified by hospital. There will be 75 subjects per arm, with the subjects~     in the comparator arm receiving standard-dose polymyxin B while the intervention arm will~     receive a second antibiotic, doripenem, with polymyxin B against the bacterial isolate in~     question. Subjects with ventilator-associated pneumonia (VAP) will additionally receive~     nebulized colistin. The primary outcome is 30-day mortality while secondary outcomes include~     microbiological clearance, time to defervescence, and toxicity of therapy, presence of~     secondary infections due to new multi-drug resistant bacteria and length of ICU stay. Plasma~     drug levels will be measured by liquid chromatography-mass spectrometry.~      Hypothesis:~      The underlying primary hypothesis is that combination antibiotic therapy (IV polymyxin B + IV~     doripenem) is superior to mono-antibiotics therapy (IV polymyxin B) in reducing 30-day~     mortality from XDR-GNB infections.~   "
109506|NCT02134093|"~     This study is to explore the effects of dexmedetomidine on postoperative cognitive~     dysfunction during one-lung ventilation in elder patients.~   "
109507|NCT02134080|"~     The purpose of this trial is to examine the safety, tolerability and feasibility in the use~     of a FAAH inhibitor for the treatment of adults with Tourette syndrome.~   "
109508|NCT02134067|"~     The purpose of this study is to determine the safety of TAS-119 and determine the most~     appropriate dose in combination with Paclitaxel for subsequent studies in patients with~     advanced solid tumors.~      TAS-119 is a novel, selective Aurora A kinase inhibitor, which has previously been~     demonstrated to enhance the activity of paclitaxel in preclinical studies~   "
109509|NCT02134054|"~     In this cross sectional and longitudinal study, patients with inflammatory bowel disease on~     biological treatment with infliximab or adalimumab will be included.~      After inclusion, the dosage of their existing biological therapy will be adjusted following~     regular trough-level and antibody-level monitoring, according to a treatment algorithm.~      Disease activity markers, fatigue and QoL will be assessed during the study. The hypothesis~     is that therapeutic drug monitoring may improve clinical disease outcome after one year of~     follow-up.~   "
109510|NCT02134041|"~     We are extending the researches of Taiwan neurosurgery traumatic brain injury (TBI) database~     which is led by Professor WT Chiu in Taipei Medical University and will recruit mild TBI~     (mTBI) participants who have ever been registered in the database. This database has been~     established for over 15 years and contains the information of over 150000 patients. It is one~     of the largest TBI database in the world.~      TBI usually results from traffic accidents, falls or violence events. Most of the victims are~     young people and the victims suffer from life-threatening and mental-physical deficits. Mild~     TBI (mTBI) usually was neglected before because its symptoms, signs are mild and mTBI~     patients usually were not obtained enough initial treatment. Therefore, mTBI might result in~     long-term cognitive and affective impairments, such as depression, indifference, anxiety,~     memory impairment, loss of attention and executive function. These late effects not only~     decrease the life quality of patients and their family but also increase the social and~     medical burden.~      Recent epidemiology studies have pointed out that TBI would increase the risk for dementia,~     especially Alzheimer disease (AD) by 2-4 times. However, the association between TBI~     severity, number of repeats, genetic factors and onset of AD remains further investigation.~      Amyloid-β (Aβ) plaques and neurofibrillary tangles are the pathological hallmarks for AD.~     Accumulation of Aβ is considered to be the first step of pathophysilogy of AD. Compelling~     researches have supported TBI accelerates the formation and accumulation of Aβ. These~     findings could link TBI with AD but the previous researches had limitations. There was lack~     of mTBI pathology data so the impacts of mTBI on Aβ accumulation were still obscure. By~     amyloid-PET, we could study the effects of mTBI on the accumulation of Aβ and this tool could~     be helpful for understanding the real impacts and pathophysiological mechanisms of mTBI on~     AD.~   "
109560|NCT02133391|"~     This study focuses on implementing and evaluating an evidence-based collaborative method of~     increasing immunization rates among preschool children, adolescents and adults within an~     Accountable Care Organization-Public Health collaborative. The infrastructure we will create~     through this project will serve as the framework for future collaborative delivery of other~     preventive services.~   "
109511|NCT02134028|"~     Primary Objective:~      Evaluate the long-term safety and tolerability of dupilumab in patients with asthma who~     participated in a previous dupilumab asthma study (DRI12544, PDY14192, EFC13579, EFC13691).~      Secondary Objectives:~      Evaluate the efficacy of dupilumab in patients with asthma who participated in a previous~     dupilumab asthma clinical study.~      Evaluate dupilumab in patients with asthma who participated in a previous dupilumab asthma~     clinical study, with regards to:~        -  Systemic exposure~        -  Anti-drug antibodies~        -  Biomarkers~   "
109512|NCT02134015|"~     1. Part A: Subjects will receive Patritumab or placebo with erlotinib. Progression-free~          survival will be the primary outcome. Subjects will need to have Epidermal Growth Factor~          Receptor (EGFR) wild-type, locally advance or metastatic NSCLC and have their cancer~          progressed after at least one prior systemic anti-cancer therapy, available recent or~          archival tumor specimen and may not have had previous EGFR-targeted regimen, anti-HER2~          (Human Epidermal Growth Factor Receptor 2), anti-HER3, or anti-HER4 therapy. Subjects~          may have high heregulin or low heregulin.~        2. Part B: Subjects will receive Patritumab or placebo with erlotinib. Overall survival~          will be the primary outcome. Subjects will need to have EGFR wild-type, locally advance~          or metastatic NSCLC and have their cancer progressed after at least one prior systemic~          anti-cancer therapy, available recent or archival tumor specimen and may not have had~          previous EGFR-targeted regimen, anti-HER2, anti-HER3, or anti-HER4 therapy. Only~          subjects with high heregulin will be enrolled.~   "
109513|NCT02134002|"~     This study represents a randomized, double blind placebo-controlled trial. Thirty cocaine~     dependant patients will be included in this study during their hospitalization for~     withdrawal. After the inclusion visit, they will be randomized to receive disulfiram 250~     mg/day or placebo over the 15 days of their hospitalization. Main outcome criteria will be~     evaluated during two TEP imaging sessions with 11Craclopride, before and after stimulation by~     methylphenidate, 8 to 15 days after randomization.~   "
109514|NCT02133989|"~     The purpose of this study is to evaluate the efficacy and safety of the ticlopidine + ginko~     biloba compared to clopidogrel in clopidogrel resistant patients undergoing carotid artery~     stent placement. The investigators hypothesized that ticlopidine + ginko biloba is superior~     than clopidogrel in terms of post-stent ischemic lesions in these patients without serious~     complications.~   "
109515|NCT02133976|"~     Psychosocial interventions are attractive options for treating chronic low back pain, and~     many approaches now have strong support for efficacy. However, few empirical data address~     whether psychosocial pain treatments work because of mechanisms specified by theory, and thus~     investigators know very little about HOW our treatments work. It may be that different~     treatments work via distinct pathways that are specific to a given treatment (single effect~     model), or it may be that different treatments work to the extent they all operate via key~     mechanisms that they share (additive effects model). Examination of specific and/or shared~     effects on outcomes of mechanisms will provide theoretical and empirical rationale for~     enhancing procedures and techniques most closely linked to strong outcomes and incorporating~     them into future interventions, while limiting the use of others that may be revealed as~     inert.~   "
109516|NCT02133963|"~     Psychosocial factors, including a previous history of depression, recent stressful life~     events, sleep disturbances during pregnancy, and depression and/or anxiety during pregnancy~     have been shown to be associated with an increased risk for the development of postpartum~     depression (PPD). Biological mechanisms underlying the relationships among these psychosocial~     risk factors for PPD, and the development of PPD, remain unclear. However, evidence from~     non-perinatal populations suggest that dysregulation in stress-reactive neuroendocrine~     factors may play a role. The primary objectives of this study are: (1) to assess the~     feasibility of enrolling second trimester pregnant women, with or without depression~     histories, into a laboratory-based study protocol which includes a mild psychosocial stressor~     and the collection of venous blood for the measurement of stress-reactive adrenocorticotropic~     hormone (ACTH) and cortisol; (2) to assess the feasibility of retaining participants, for a~     brief postpartum phone interview, after completion of the second trimester assessments; and~     (3) to establish proof of concept for measuring group differences, between women with or~     without depression histories, in second trimester prenatal measures of neuroendocrine stress~     reactivity, depressive and anxious symptoms, recent stressful life events, and sleep quality.~   "
109517|NCT02133950|"~     A single centre observational study into the segmentation of preimplantation genetic~     diagnosis (PGD) treatment by comparing cumulative pregnancy rates following cryopreservation~     of all genetically transferable embryos after PGD, compared to fresh embryo transfer~     cumulative with frozen embryo transfer of genetically transferable embryos.The primary aim of~     the study is to assess the feasibility and effectiveness of segmentation in terms of~     pregnancy rates. The secondary aim is to assess the logistic advantage of segmentation in PGD~     cycles.~      Experimental questions~        1. Is the cumulative live birth rate rate of a single PGD treatment when all genetically~          transferable embryos are cryopreserved by vitrification prior to consecutive in utero~          transfer in unstimulated cycles, superior to PGD treatment with fresh embryo transfer~          cumulative with transfer of supernumerary cryopreserved embryos?~        2. Does the technique of segmentation allow better planning of DNA amplification and~          genetic analysis?~      Design The proposed design is a pragmatic, prospective randomised controlled trial~   "
109518|NCT02133937|"~     This single-center, randomized open-label, single-dose, parallel group study will investigate~     the relative bioavailability of a high concentration liquid formulation (HCLF) versus the~     reference lyophilized formulation (LyoF) of gantenerumab. Healthy volunteers will be~     randomized 1:1 to receive single-dose gantenerumab by subcutaneous injection.~   "
109572|NCT02133235|"~     The need of fiberoptic bronchoscopy for placing an endobronchial blocker. Endobronchial~     blockers (EBB) have been presented effective and safe alternative for lung separation in~     vedio-assisted thoracoscopic (VATS) operations. In this study, the investigators will~     randomize the patients receiving VATS operation with EBB into two groups: one group will~     receive the conventional bronchoscopic guided EBBs placement, the other group receive two~     step procedure without confirmation by fiberoptic bronchoscopy.~   "
110068|NCT02126748|"~     The purpose of this study is to investigate the effectiveness of two airway clearance~     techniques; Intrapulmonary Percussive Ventilation and Assisted Autogenic Drainage in~     hospitalized infants under the age of 2 with acute viral bronchiolitis.~   "
109519|NCT02133924|"~     This research trial is designed to study the safety and effectiveness of combining the study~     drug, Natalizumab (Tysabri®) with the standard treatment, the use of steroids, as a new~     treatment for acute graft versus host disease (acute GVHD). GVHD is the most common serious~     complication, after bone marrow transplant. GVHD occurs when the donor cells (the graft),~     treat the recipient's body as foreign and attack the cells in the recipient's body. During~     this immune system response, donor cells damage body tissues, such as the skin, liver,~     stomach, and/or intestines. Acute GVHD can be severe and if severe, potentially fatal to the~     transplant recipient. Acute GVHD usually happens within the first several months after~     transplant.~      The goal of this research is to develop a safer and more effective treatment for acute GVHD,~     and particularly for acute GVHD that affects the gastrointestinal (or GI) tract, with the~     ultimate goal being safer and more effective transplant therapies for blood cancers such as~     leukemia, lymphoma, and multiple myeloma.~   "
109520|NCT02133911|"~     Recent data suggest that areas of fibrosis and hibernating myocardium develop in patients~     with non ischemic dilated cardiomyopathy. Ranolazine is a new drug, developed to releave~     symptoms of angina in patients with stable coronary disease that is not suitable for surgical~     or percutaneous revascularization. It has been shown that in patients with stable coronary~     disease Ranolazine improves myocardial perfusion as shown with myocardial nuclear imaging.~     The aim of this trial is to evaluate effects of ranolazine on myocardial perfusion in~     patients with dilated cardiomyopathy.~   "
109521|NCT02133898|"~     This is an open-label study assessing the efficacy of l-methylfolate as monotherapy in~     patients with mild to moderate major depressive disorder (MDD). The plan is to enroll 75~     patients with mild to moderate MDD based on the Structured Clinical Interview for DSM-IV~     (SCID) that have a Hamilton Depression Rating Scale-24 (HDRS-24) score between 8-24. The~     investigators will collect genotype data on methylenetetrahydrofolate Reductase (MTHFR), MTR~     and MTRR in this patient population. Subjects will be able to receive their genotype results,~     on request, upon completion of the study. The investigators hypothesize that depressed~     patients will be more likely to have a mutation in the MTHFR gene~   "
109522|NCT02133885|"~     Hypertension (HTN) is the single most prevalent risk factor for cardiovascular disease,~     diabetes, obesity and metabolic syndrome. Despite advances in life style modification and~     multi-drug therapies, 20-30% of all hypertensive patients remain resistant.~      These individuals exhibit autonomic dysregulation due to elevated sympathetic activity and~     norepinephrine spillover, and low parasympathetic activity. It is generally accepted that~     this uncontrolled, resistant HTN is primarily neurogenic in origin, involving over activity~     of the sympathetic nervous system that initiates and sustains HTN. Thus, a mechanism-based~     breakthrough is imperative to develop novel strategies to prevent and perhaps eventually cure~     neurogenic hypertension (NH).~      This study is a double-blind, placebo-controlled, cross-over design to test the hypothesis~     that minocycline treatment would produce antihypertensive effects in drug-resistant~     neurogenic hypertensive individuals.~   "
109523|NCT02133872|"~     Hypertension (HTN) is the single most prevalent risk factor for cardiovascular disease,~     diabetes, obesity and metabolic syndrome. Recent American Heart Association (AHA) statistics~     indicate that one-third of all adults in the United States of America suffer from HTN.~     Despite advances in life style modification and multi-drug therapies, 20-30% of all~     hypertensive patients remain resistant.~      These individuals exhibit autonomic dysregulation due to elevated sympathetic activity and~     norepinephrine spillover, and low parasympathetic activity. It is generally accepted that~     this uncontrolled, resistant HTN is primarily neurogenic in origin, involving over activity~     of the sympathetic nervous system that initiates and sustains HTN. A surgical approach such~     as the recently developed Simplicity Catheter assisted renal denervation remains one of the~     few options available to these patients. Thus, a mechanism-based breakthrough is imperative~     to develop novel strategies to prevent and perhaps eventually cure neurogenic hypertension~     (NH). This study is designed to evaluate a low and high dose of minocycline to test the~     hypothesis that minocycline treatment would produce antihypertensive effects in~     drug-resistant neurogenic hypertensive individuals. Minocycline has been selected because of~     its demonstrated effects on inhibiting microglial activation and its ability to penetrate the~     blood brain barrier. There is no other compound available that is safer and displays~     specificity better than Minocycline in inhibiting microglial activation. Thus, the potential~     therapeutic benefits of this inexpensive, well tolerated, already FDA-approved drug that has~     minimal side effects would be enormous.~   "
109524|NCT02133859|"~     Sleep disordered breathing is very common in patients with chronic heart failure with~     reported prevalence rates of 50-75%. Adaptive Servo-Ventilation (ASV) can be used to treat~     sleep apnea in these patients. This is an observational study to document changes in~     respiratory parameters in HF patients using ASV for a period of 12 months.~   "
109525|NCT02133846|"~     The purpose of this study is to determine the safety and tolerability [maximum tolerated dose~     (MTD) within planned dosing range] of intravenous (IV) infusions of TPI 287 administered once~     every 3 weeks for 9 weeks (for a total of 4 infusions) in patients with primary four repeat~     tauopathies (4RT), corticobasal syndrome (CBS; also called corticobasal degeneration, CBD) or~     progressive supranuclear palsy (PSP).~   "
109526|NCT02133833|"~     This is a prospective, self-controlled study to evaluate the efficacy of the Quantum spectrum~     radiation emitter for adhesive capsulitis.~   "
109527|NCT02133820|"~     To assess whether an opioid antagonist has any impact on the release of a strong painkiller~     in the blood when it is given to healthy volunteers when they have eaten and also when they~     have fasted.~   "
109528|NCT02133807|"~     To evaluate whether specific lipoprotein(a) apheresis on the top of optimal medical therapy~     could affect atherosclerotic disease burden in coronary and carotid arteries of coronary~     heart disease patients with elevated Lp(a) levels.~   "
109529|NCT02133794|"~     The purpose of this project is to determine if using tomosynthesis, in conjunction with~     x-ray, is better at detecting hip fractures than using x-ray alone. The goal of this study~     will be to include the use of tomosynthesis with x-ray as usual practice when a patient comes~     to the emergency room with symptoms of a hip fracture.~   "
109530|NCT02133781|"~     This is an exploratory study using a strategy that has not been previously employed to~     investigate the effects of age and vaccine type on specific kinds of immune responses to~     licensed, seasonal 2009-2010 influenza vaccines in children and adults.~   "
109532|NCT02133755|"~     The primary aim of this study is to determine the effect of dopamine agonist therapy on~     insulin resistance in lean vs. obese women with polycystic ovary syndrome. Polycystic ovary~     syndrome (PCOS) is a common metabolic abnormality in women. The diagnosis of PCOS relies on a~     constellation of symptoms and signs (problems with ovulation, clinical and/or biochemical~     signs of hyperandrogenism and cystic ovaries). Though not a diagnostic feature, insulin~     resistance (IR) is a hallmark of PCOS and up to 80% women with PCOS have IR. Although IR is~     more significant in obese women with PCOS, even lean women can be insulin resistant. No~     current therapy addresses the problem of insulin resistance in PCOS. Studies have suggested a~     dopamine deficiency in patients with PCOS, which may underlie the insulin resistance and may~     have a pathogenetic role in the development of PCOS. No study to date has assessed the impact~     of dopamine agonist therapy on IR in patients with PCOS.~   "
109533|NCT02133742|"~     Despite substantial improvements of patients outcome in advanced RCC, durable and complete~     response is uncommon. The majority of patients eventually develop resistance and exhibit~     disease progression. Combining a PD-1 inhibitor, which has shown single-agent efficacy with~     axitinib may provide additional clinical benefit compared to axitinib alone.~   "
109534|NCT02133729|"~     Gestational diabetes (GDM) is defined by abnormal glucose tolerance during gestation. This~     complication occurs in 4-10% and is associated with fetal complications and macrosomia. In~     addition, women with GDM have an increased risk to develop type 2 diabetes after delivery.~     Despite recommendations, it is difficult to follow-up all women with GDM during the~     postpartum period due to high numbers of subjects that exceed usual healthcare resources. It~     is therefore necessary to focus clinical attention toward women at high risk of type 2~     diabetes in order to set adequate preventive strategies.~   "
109535|NCT02133716|"~     The aim of this study is to assess the non-inferiority of non- pharmacological breast milk~     expressed versus oral sucrose in relief procedural pain of venipuncture in preterm neonates.~      This is an experimental comparative study of non-inferiority randomized crossover, to be~     performed in Neonatal units of hospitals in the Community of Madrid.~      The 54 pair of preterm that after the selection criteria are included in the study, they~     performed the randomization of the sequence and breast milk expressed receive oral or 24%~     sucrose.~      The doses administered are: 0.1ml preterm less than 27 weeks corrected gestational age (CGA),~     0.25 ml for infants 27 to 31 weeks CGA and 0.5 ml for infants of 32-37 weeks. Both groups~     will be accompanied by non-nutritive sucking and swaddling and administered two minutes prior~     to venipuncture.~      The outcome variable, pain, will be determined by the scale Premature Infant Pain Profile~     (PIPP) and by percent of cry.~      Data for the primary objective was analysed per intention to treat. This study was approved~     by local ethical committee.~   "
109536|NCT02133703|"~     This non-therapeutic trial is for women who have received results of genetic testing for~     BRCA1/2 mutations. The trial compares decision support tools designed to facilitate informed~     decision making regarding risk management following testing to usual care. The researchers~     will test separate decision support tools for women who receive positive test results and~     women who receive negative/inconclusive test results. Among women who receive a positive test~     result, an interactive decision support intervention will be compared to a print~     intervention. Among women who receive an inconclusive result, an interactive intervention~     will be compared to usual care.~   "
109537|NCT02133690|"~     This is a Phase 3 multicentre, randomized, double blind, placebo-controlled study to~     determine the effectiveness of the rotavirus vaccine.~   "
109538|NCT02133677|"~     Brain metastasis (BM) is among the most feared complications in cancer because even small~     tumors may cause incapacitating neurologic symptoms. It is observed in more than 50% of~     patients with lung cancer and 15% to 25% of patients with breast cancer. Temozolomide (TMZ)~     is an oral alkylating agent that crosses blood-brain barrier (BBB). This pilot study aims to~     evaluate the efficacy, safety and tolerability of whole-brain radiotherapy (WBRT) plus~     concomitant TMZ in lung cancer and breast cancer patients with BM.~   "
109539|NCT02133664|"~     The primary aim is to collect data to determine the correct effect size on the primary~     outcome to aid in the design of a larger study: The primary outcome is to determine if lipoic~     acid and omega-3 fatty acids can improve cognitive function in people with multiple sclerosis~     that have cognitive dysfunction.~   "
109540|NCT02133651|"~     Clostridium difficile infection is the most common cause of antibiotic-associated diarrhea.~     Treatment of this infection usually occurs using other antibiotics, but many individuals have~     persistent diarrhea and multiple relapses. Fecal Transplant (FMT), or Intestinal Microbiota~     Transplantation, (IMT) has been shown to be efficacious when administered after treatment for~     C. difficile. This study will involve taking biopsies from patients during their FMT/IMT via~     colonoscopy, and determine if there are differences in the mucosal flora as compared to the~     stool flora. The investigators hope to discover the critical parts of a healthy microbiota.~   "
109541|NCT02133638|"~     The aim of this study is to distinguish possible differences in frequency of delirium after~     Volatile Induction and Maintenance of Anesthesia and Total Intravenous Anesthesia in case of~     undeliberate cerebral desaturation during non-cardiac surgery.~   "
109542|NCT02133625|"~     The proposed investigation is a Phase 1 trial to determine the safety, tolerability, and~     maximum tolerated dose (MTD) of the combination of pioglitazone ( and carboplatin patients~     with advanced or metastatic solid malignancies.~   "
109543|NCT02133612|"~     Esophageal cancer is a highly aggressive malignancy with a poor overall outcome.~        -  Five year survival rate after radical esophagectomy is modest at about 40%.The patients~          with regional lymph node metastases have worse outcome than those without lymph node~          metastases.~        -  No standard postoperative adjuvant chemotherapy has ever been established.~   "
109587|NCT02133040|"~     The investigators wish to evaluate the effect of thyroid hormones on brown adipose tissue in~     humans in an observational study on patients with thyrotoxicosis. In the investigators~     evaluation the investigators will use FDG-PET/CT, indirect calorimetry and fat biopsies in~     the acute phase of the disease and in the euthyroid phase after treatment.~      It is the investigators hypothesis that high levels of circulating T3 might affect amount and~     function of brown adipose tissue.~   "
112723|NCT02091986|"~     The purpose is to investigate the Efficacy and Safety of Symbicort pMDI 80/2.25 μg and~     Symbicort pMDI 80/4.5 μg, Compared with Budesonide pMDI 80 μg, 2 Actuations Twice Daily, in~     Children Ages 6 to <12 Years with Asthma during 12 weeks.~   "
109544|NCT02133599|"~     Each year approximately 2,900 children and adolescents less than 20 years old are diagnosed~     with acute lymphoblastic leukemia or acute lymphoblastic lymphoma in the United States. (For~     the purposes of this protocol, ALL will be used to refer to patients with either acute~     lymphoblastic leukemia or acute lymphoblastic lymphoma as patients are treated in the same~     manner.) High-dose methotrexate (HDMTX; 5 g/m2) remains an important component of standard~     treatment for most ALL patients. However, high plasma and intracellular MTX concentrations~     (defined as a MTX level of >1 µmol/L at 42 hours and > 0.40 µmol/L at 48 hours) can quickly~     lead to acute kidney, bone marrow, liver, skin, central nervous system, and gastrointestinal~     toxicities requiring extended hospitalization and delays in subsequent chemotherapy~     treatments.~      This study seeks to identify more sensitive markers of kidney injury that could serve as~     better predictors of delayed excretion and/or toxicity of HDMTX. This study is a pilot~     repeated-measures feasibility study.~      Hypothesis 1: Directly measured GFR (mGFR, a type of test to measure the filtering rate of~     kidneys) by iohexol clearance obtained prior to HDMTX will demonstrate greater sensitivity~     and specificity for prediction of delayed MTX excretion and/or toxicity in children and~     adolescents with ALL than serum creatinine (sCr) alone or sCr used for eGFR calculation. If~     this study proves that mGFR is a better predictor of delayed MTX excretion and/or toxicity,~     then another study will be developed in the future to determine if modifying the HDMTX dose~     or adjusting supportive care based on mGFR will prevent delayed clearance and toxicity~     without impacting patient survival.~      Hypothesis 2: Those participants prospectively demonstrating delayed MTX excretion or~     toxicity will exhibit elevation of kidney injury biomarkers less than 24 hours following~     initiation of HDMTX infusion compared to pre-chemotherapy measurements. These biomarkers will~     increase prior to a measurable sCr elevation.~   "
109545|NCT02133586|"~     The U.S. Environmental Protection Agency has traditionally examined the effects of single~     pollutant exposure on human health outcomes; however, to provide a better assessment of~     pollutant exposure-associated effect on human health the Agency is moving toward a~     multi-pollutant approach. Ozone (O3) and nitrogen dioxide (NO2) are national ambient air~     quality standards (NAAQS) criteria pollutants that are major constituents of ambient air~     pollution. This study will address the Agency's goals by investigating the cardiopulmonary~     health effects of sequential exposure to O3 and NO2 in healthy adult human volunteers. The~     findings of this study will provide data that will inform risk assessment models for O3 and~     NO2 exposures. Additionally, the findings will provide insight into how the human health~     effects of multi-pollutant exposures differ from those of single pollutant exposures.~   "
109546|NCT02133573|"~     Neurodevelopmental disability is now recognized as the most common long-term complication~     after cardiac surgery in neonates. Research studies have shown that progesterone is critical~     to the development of the brain and in a variety of clinical situations including brain~     injury can protect the brain.~      The purpose of this research study is to determine whether progesterone administered during~     the 3rd trimester of pregnancy (24-39 weeks) to pregnant women protects the brain of unborn~     babies with CHD and improves their neurodevelopmental outcomes after heart surgery.~   "
109547|NCT02133560|"~     Purpose: Assess whether intensive training with education and daily remote monitoring with~     provider involvement has a lasting positive impact on adherence to medication management. The~     study will seek to enroll 25 subjects with sickle cell disease or thalassemia, and less than~     100% compliance for taking iron chelators in the previous three month prior to participation~     in the study. Subjects will be asked to monitor their daily iron chelator administration by~     taking a video recording of preparing it and ingesting at least one sip. Subjects will also~     use a medication log to record daily administration of medication, and meet with study staff~     monthly for educational activities. The data collected will be analyzed to describe patient~     adherence and comfort level with the process of daily recording of medication management.~     Mean percent adherence in the pre-study periods and each of the study periods will be~     analyzed and compared.~   "
109548|NCT02133547|"~     Primary ciliary dyskinesia (PCD) is a rare genetic disorder characterized by impaired airway~     mucociliary clearance leading to recurrent respiratory infections, bronchiectasis and~     eventually respiratory insufficiency. Diagnosis of PCD is difficult and relies on complex~     methods which are not widely available (1).~      Nasal nitric oxide (nNO) is reduced in PCD patients as compared to normal subjects, and nNO~     measurement has been proposed as a non-invasive screening tool for PCD. However, nNO~     measurement techniques are not standardized and reference values are lacking (2, 3).~      The NIOX MINO is a handheld analyzer developed for the non-invasive measurement of exhaled NO~     (eNO) in asthmatics. Measurement of nNO with the NIOX MINO has been reported in only few~     studies (4-6), which mainly compared the NIOX MINO with others NO analyzers. However, no~     study attempted to establish reference values with the NIOX MINO in a large number of normal~     subjects.~      One critical issue in nNO measurement is to avoid contamination of nasal air by exhaled~     alveolar air during nNO sampling. This can be obtained by either breath holding, or by a~     breathing technique allowing soft palate closure during sampling, such as mouth breathing~     again resistance. However, as sampling times with the NIOX MINO are long (2 minutes at a flow~     of 2 ml/min, and 45 seconds at a flow of 5 ml/min), these techniques may be difficult to~     apply.~      In this pilot study, we will determine normal nNO values in 100 healthy men and women aged 20~     to 70 years using 3 different breathing techniques:~        1. breath holding during 45 seconds~        2. mouth breathing through a fixed resistance (a straw), to create a small positive~          pressure in the oropharynx during expiration only~        3. mouth breathing through a continuous positive airway pressure (CPAP) apparatus, which~          produces continuous soft palate closure during quiet spontaneous breathing, thus~          allowing long sampling times for nNO measurement.~      This study will allow: 1) to determine whether nNO can be reliably measured with the NIOX~     MINO in adult normal subjects, 2) to identify the most reproducible breathing technique, 3)~     to determine normal values of nNO as measured by the NIOX MINO, and 4) to explore possible~     differences between genders and age groups.~      References:~        1. J.S.A. Lucas, W.T. Walker, C.E. Kuehni and R. Lazor. Primary ciliary dyskinesia. Eur~          Respir Mon. 2011; 54: 201-217.~        2. ATS/ERS Recommendations for Standardized Procedures for the Online and Offline~          Measurement of Exhaled Lower Respiratory Nitric Oxide and Nasal Nitric Oxide, 2005. Am J~          Respir Crit Care Med 2005; 171: 912‑30.~        3. Marthin JK, Nielsen KG. Choice of nasal nitric oxide technique as first-line test for~          primary ciliary dyskinesia. Eur Respir J 2011; 37: 559‑65.~        4. Marthin JK, Nielsen KG. Hand-Held Tidal Breathing Nasal Nitric Oxide Measurement - A~          Promising Targeted Case-Finding Tool for the Diagnosis of Primary Ciliary Dyskinesia.~          PLoS ONE 2013; 8: e57262.~        5. Weschta M, Deutschle T, Riechelmann H. Nasal fractional exhaled nitric oxide analysis~          with a novel hand-held device. Rhinology 2008; 46: 23‑7.~        6. Maniscalco M, Laurentiis G de, Weitzberg E, Lundberg JO, Sofia M. Validation study of~          nasal nitric oxide measurements using a hand-held electrochemical analyser. Eur J Clin~          Invest 2008; 38: 197‑200.~   "
109549|NCT02133534|"~     The purpose of this study is to see if patients with chronic kidney disease have endothelial~     cells that don't function properly, which is thought to be a marker for cardiovascular risk.~     Endothelial cells line the heart and blood vessels. The investigators will treat your high~     cholesterol with a cholesterol-lowering drug (atorvastatin, or Lipitor). They will determine~     if this cholesterol lowering drug improves subjects' cholesterol as well as the function of~     endothelial cells.~   "
109550|NCT02133521|"~     This is a prospective, randomized, double-blind, and controlled clinical study to investigate~     the effects of DLBS1033 in conjunction with standard therapy compared to standard therapy~     alone in acute ischemic stroke patients. It is hypothesized that the improvement in~     functional outcomes as measured by NIHSS and BI as well as the improvement in haemostatic~     parameters as measured by thrombocyte aggregation test (TAT), fibrinogen, and d-dimer in DLBS~     group will be significantly greater than those in the control group.~   "
109551|NCT02133508|"~     This multicenter, retrospective and prospective observational, cohort study will examine the~     effect of second-line Tarceva treatment on long response in non-small cell lung cancer~     (NSCLC) participants with wild type or unknown EGFR status. Participants will be observed~     from the start of treatment for 8 months or until death. The extension of the retrospective~     versus prospective observation will depend on the lag between the date of the participant~     enrollment and the date of beginning of erlotinib therapy.~   "
109552|NCT02133495|"~     The purpose of this study is to Evaluate the efficacy and longevity of a Human-derived,~     non-cadaveric, acellular dermal implant (BellaDerm) as a posterior spacer graft in the~     correction of lower eyelid retraction, taking into consideration issues associated with the~     use of acelular dermis such as contraction and potential regression of repairs.~   "
109553|NCT02133482|"~     The primary objective of this trial is to investigate the safety and tolerability of BI~     639667 in healthy male subjects following oral administration of single rising doses.~      Secondary objectives are the exploration of the pharmacokinetics (PK) including dose~     proportionality as well as investigation of linearity and pharmacodynamics (PD) of BI 639667~     after single dosing and the assessment of the PK/PD relationship.~   "
109554|NCT02133469|"~     A parallel-group, randomized, open-label study will be performed in subjects receiving PCV7~     and subjects receiving controlled vaccine Hib vaccine, to claim the efficacy of PCV7 in the~     prevention of NP carriage of vaccine-serotype S. pneumoniae (serotypes 4, 6B, 9V, 14, 18C,~     19F, and 23F combined) in 2 to 5 years old healthy Chinese children.~   "
109555|NCT02133456|"~     To monitor the safety of Shanghai Institute of Biological Products Company's influenza~     vaccine in subjects aged 3 years and older through Adverse Events Following Immunization~     Surveillance System of China.~      The hypothesis is that there is no significant difference in the occurrence of adverse events~     among influenza vaccines manufactured by SIBP and other companies.~   "
139453|NCT01742000|"~     The purpose of this study is to investigate the anti-atherosclerotic action of natural drug~     Karinat based on phytoestrogen-rich botanicals in postmenopausal women.~   "
109561|NCT02133378|"~     A new topical hemostatic agent composed of a specifically-formulated porous collagen matrix,~     coated on one side with a thin protein bonding layer (known as NHS-PEG) has been reported to~     be extremely effective, in addition to traditional means, in terminating bleeding during~     cardiac operations with control rates as high as 97,5%. The investigators compared such~     hemostatic agent (Hemopatch; Baxter Inc, Deerfield, IL) with traditional optimized hemostasis~     routine.~      Following sample size calculation, in a prospective randomized study design, 100 patients~     will be treated with Hemopatch and 100 patients will receive traditional optimized hemostasis~     routine (comparison group).~      To make the two cohorts as comparable as possible enrollment will be restricted to moderately~     bleeding vascular anastomosis of Dacron grafts to ascending aorta or moderately bleeding~     transversal aortotomy.~      Study endpoints are the following: rate of successful intraoperative hemostasis (identified~     by cessation of bleeding in less than 3 minutes from application) and time required for~     hemostasis; overall postoperative bleeding; rate of transfusion of blood products; rate of~     surgical revision for bleeding; postoperative morbidity; and intensive care unit stay.~   "
109562|NCT02133365|"~     This is an investigation of a mindfulness and interoceptive exposure intervention in patients~     with atrial fibrillation, to decrease anxiety sensitivity, symptom burden, and atrial~     fibrillation recurrence.~   "
109563|NCT02133352|"~     This is a single center, open-label trial designed to assess the safety and efficacy of~     ranolazine (Ranexa) in patients with pulmonary hypertension associated with left ventricular~     diastolic dysfunction. All patients will receive active drug. The study includes a screening~     period, 6 month treatment period and a follow up period. Eligible patients who provide~     informed consent and who meet all inclusion/exclusion criteria will be enrolled in this~     study.~      There is neither proven therapy for patients with diastolic dysfunction-associated pulmonary~     hypertension nor for patients with diastolic dysfunction alone. Ranolazine, an inhibitor of~     cardiac repolarization (sodium channels), could represent a new and effective treatment of~     this entity.~   "
109564|NCT02133339|"~     This single ascending dose study is to determine and evaluate the safety and tolerability of~     TRN-157 in approximately 40 healthy subjects.~   "
109565|NCT02133326|"~     This study will compare how effective a single dose of an intravenous (IV) ibuprofen is when~     compared to single dose of IV acetaminophen in reducing pain. We will administer this study~     medication thirty minutes prior to removal of wisdom teeth. We want to see if administering~     these drugs prior to surgery may reduce post-operative pain.~      Administration of nonsteroidal anti-inflammatory drug before the onset of inflammation during~     surgery will reduce postoperative pain following third molar extraction when compared to the~     acetaminophen group. Subjects receiving nonsteroidal anti-inflammatory drug will consume less~     opioid medications compared to those receiving preemptive acetaminophen.~   "
109566|NCT02133313|"~     The time on peritoneal dialysis may be limited for a significant number of patients that use~     this modality of renal replacement therapy due to the inability of the peritoneal membrane to~     clear solutes or achieve adequate ultrafiltration, termed peritoneal membrane failure (PMF).~     This can be devastating for patients who have become accustomed to the quality of life~     provided by peritoneal dialysis and who otherwise have done well on this therapy. There is~     clinical evidence suggesting that icodextrin preserves the peritoneal membrane transport~     characteristics which may be linked to reduced cumulative glucose exposure of the peritoneal~     mesothelial cells. Theories to explain the role of dextrose in PMF have focused for the most~     part on the high intracellular concentrations of glucose without consideration to the~     potential pathogenic role of the glucose transporters which allow glucose entry into the~     cell. Experimental evidence in non-mesothelial cell lines indicate that some cellular~     processes that occur under high glucose conditions may not be related to intracellular~     glucose metabolism but to the type of glucose transporter allowing glucose entry. 3,4~     However, little is known about these glucose transporters in peritoneal mesothelial cells and~     their potential role in the development of PMF.~      We hypothesize the following~        -  The presence of Sodium Glucose Co-transporter (SGLT1) on peritoneal mesothelial cells~          plays a role in PMF under hyperglycemic conditions.~        -  Regulation of pro-fibrotic mediators such as reactive oxidative species,transforming~          growth factor β, and vascular endothelial growth factor are modulated by SGLT1~          activation by glucose rather than glucose metabolism or concentration.~        -  Icodextrin does not activate the SGLT1 transporter establishing a mechanism that may~          explain the beneficial effects of icodextrin on peritoneal membrane transport.~   "
109567|NCT02133300|"~     Critically ill patients with a predicted prolonged ICU stay will receive neuromuscular~     electrical stimulation (NMES) of one quadriceps muscle. Whether the dominant or non-dominant~     side will be stimulated is chosen randomly by using opaque sealed envelopes. The patients~     will receive electrical stimulation for 1h for 7 consecutive days. The stimulated and~     non-stimulated side will be compared for it's thickness (by using ultrasound imaging), muscle~     strength if the patients are awake and cooperative (using the medical research council scale~     and handheld dynamometry) and a muscle biopsy will be taken. As a primary outcome the~     investigators hypothesize that electrical stimulation will preserve muscle mass with respect~     to the non-stimulated quadriceps. As secondary outcomes the investigators hypothesize that~     electrical stimulation can reduce muscle strength loss and leads to a better protein balance~     and thicker muscle fibers in the stimulated quadriceps.~   "
109568|NCT02133287|"~     To evaluate The Safety and Efficacy of 'AVI' Stent Comparing with Firebird2® For Treating~     Coronary Revascularization.~   "
109569|NCT02133274|"~     The purpose of this study is to determine whether a brief psychosocial intervention together~     with early palliative care are feasible, acceptable and effective in the reduction of~     depressive symptoms of patients with advanced cancers starting first line palliative~     chemotherapy.~   "
109570|NCT02133261|"~     The purpose of this research study is to learn if a new 7 day patch ECG recording monitor can~     serve the same purpose as standard monitoring systems. The new 7day patch is significantly~     smaller and lighter than previous ECG recorders.~   "
109571|NCT02133248|"~     Many people who are on the wait list for a kidney transplant have harmful antibodies, called~     donor specific antibodies (DSA), which will attack foreign tissue such as the transplanted~     organ. These people are considered to besensitized. Prior to receiving a kidney, these~     patients undergo desensitization treatments to remove these harmful antibodies. Levels of DSA~     are measured after desensitization, but the cells that produce the DSA, donor specific B~     cells (DSB), have not generally been measured. Additionally, if a person experiences chronic~     rejection due to antibodies they are also desensitized, but only the DSA are measured. This~     study will measure the DSA and, using new techniques, the DSB in two study groups: those who~     are receiving an organ and those experiencing chronic antibody mediated rejection after~     receiving an organ. The hypothesis is people with higher levels of DSB after desensitization~     are more likely to develop antibody mediated rejection.~   "
125598|NCT01923480|"~     The purpose of this study is to determine the best rate of infusion of amino acids (15%~     CLINISOL - sulfite-free (Amino Acid) Injection) for nutrition in subjects with with stages II~     to IVB head and neck cancer.~   "
109573|NCT02133222|"~     Therapies that target specific molecules markedly inhibit cancer growth in several~     malignancies, and provide valuable strategies for the treatment of advanced melanoma. In~     recent years, BRAF and KIT have become established therapeutic targets in melanoma patients~     showing activating mutations in these oncogenes. However, it is crucial that genetic~     mutations present in the melanoma lesions are identified if the investigators are to design~     tailormade therapies for individual patients. The tumour genotypes that determine the~     selection of molecular-targeted therapies are usually identified in primary tumours; however,~     primary tumours are not always representative of metastases. Circulating free DNA may be a~     source of valuable information because it can be obtained via routine blood sampling, it~     provides real-time information about a patient's current disease state, and it allows~     monitoring and molecular characterization before and after chemotherapy. The aim of the study~     is to determine the mutational status in circulating DNA in melanoma metastatic patients,~     with the Sequenom Mass Array, a next generation sequencing technology. Results obtained~     before and after treatment will be compared with the primary tumor genotype.~   "
109574|NCT02133209|"~     112 migraine subjects will be initially randomly assigned to Mindfulness-Based Stress~     Reduction (MBSR) or a Stress Management for Headache group (SMH). Outcomes, including~     headache frequency and impact and brain activity, will be assessed at baseline, prior to~     intervention, and at 3-, 6-, and 12-months.~   "
109575|NCT02133196|"~     Background:~      The NCI Surgery Branch has developed an experimental therapy that involves taking white blood~     cells from patients' tumors, growing them in the laboratory in large numbers, and then giving~     the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes, or TIL~     and we have given this type of treatment to over 100 patients. In this study, we are~     selecting a specific subset of white blood cells from the tumor that we think are the most~     effective in fighting tumors and will use only these cells in making the tumor fighting~     cells.~      Objective:~      The purpose of this study is to see if these specifically selected tumor fighting cells can~     cause non-small cell lung cancer (NSCLC) tumors to shrink and to see if this treatment is~     safe.~      Eligibility:~      - Adults age 18-70 with NSCLC who have a tumor that can be safely removed.~      Design:~        -  Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and~          undergo a history and physical examination, scans, x-rays, lab tests, and other tests as~          needed~        -  Surgery: If the patients meet all of the requirements for the study they will undergo~          surgery to remove a tumor that can be used to grow the TIL product.~        -  Leukapheresis: Patients may undergo leukapheresis to obtain additional white blood~          cells. {Leukapheresis is a common procedure, which removes only the white blood cells~          from the patient.}~        -  Treatment: Once their cells have grown, the patients will be admitted to the hospital~          for the conditioning chemotherapy, the TIL cells and aldesleukin. They will stay in the~          hospital for about 4 weeks for the treatment.~      Follow up: Patients will return to the clinic for a physical exam, review of side effects,~     lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1~     year as long as their tumors are shrinking. Follow up visits take up to 2 days.~   "
109576|NCT02133183|"~     This partially randomized pilot phase I trial studies how much sapanisertib reaches the brain~     tumor and how well it works when given before and after surgery in treating patients with~     glioblastoma that has grown or come back and requires surgery. Sapanisertib may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
109577|NCT02133170|"~     This is a parallel 3-group, multicenter, prospective, randomized, single-blind (evaluator)~     controlled pilot trial, with a 38- week follow-up. Patients diagnosed with bipolar disorder~     (BD) according to DSM -5 criteria for mild depression or subsyndromal depressive symptoms are~     assigned to one of the following 3 treatment groups: 1) psychopharmacological treatment plus~     Mindfulness Based Cognitive Therapy (MBCT); 2) psychopharmacological treatment plus~     structured group psychoeducation; 3) treatment as usual (TAU), including standard psychiatric~     care with standard pharmacologic treatment.~   "
109578|NCT02133157|"~     Sulfatinib (HMPL-012) is a novel oral small molecule that selectively inhibits vascular~     endothelial growth factor receptors (VEGFR) 1, 2, and 3 and inhibits FGFR kinase activity has~     demonstrated potent inhibitory effects on multiple human tumor xenografts. This~     first-in-human study is conducted to assess the maximum tolerated dose (MTD) and recommended~     dose for phase II ,to evaluate the pharmacokinetics , safety and preliminary anti-tumor~     activity of HMPL-012 at single doses and multiple doses .~   "
109579|NCT02133144|"~     A. BACKGROUND Accumulation of fat in the liver due to non-alcoholic causes (NAFLD) is~     associated with hepatic insulin resistance, which impairs the ability of insulin to inhibit~     the production of glucose and VLDL . This leads to increases in serum glucose, insulin and~     triglyceride concentrations as well as hyperinsulinemia. Recent epidemiologic studies have~     shown that a major reason for the metabolic syndrome as well as the accompanying increased~     risk of cardiovascular disease and type 2 diabetes is overconsumption of simple sugars. The~     investigators have recently shown that overeating simple sugars (1000 extra calories/day,~     CANDY diet) increases liver fat content by 30% within 3 weeks (4), and recapitulates~     features of the metabolic syndrome such as hypertriglyceridemia and a low HDL cholesterol~     concentration.~      The fatty acids in intrahepatocellular triglycerides may originate from peripheral lipolysis,~     de novo lipogenesis, uptake of chylomicron remnants by the liver and from hepatic uptake of~     fatty acids released during intravascular hydrolysis of triglyceride-rich lipoproteins (the~     spillover pathway). A classic study using stable isotope methodology by the group of~     Elisabeth Parks showed that in subjects with NAFLD, the excess intrahepatocellular~     triglycerides originate from peripheral lipolysis and de novo lipogenesis.~      It is well-established that ingestion of a high carbohydrate as compared to high fat diet~     stimulates de novo lipogenesis in humans. Meta-analyses comparing isocaloric high fat and~     high carbohydrate diets have shown that high carbohydrate but not high fat diets increase~     increase serum triglycerides and lower HDL cholesterol. Since hypertriglyceridemia results~     from overproduction of VLDL from the liver, these data suggest the composition of the diet~     influences hepatic lipid metabolism. Whether this is because overfeeding fat leads to~     preferential deposition of fat in adipose tissue while high carbohydrate diets induce a~     relative greater increase in liver fat is unknown. There are no previous studies comparing~     effects of chronic overfeeding of fat as compared to carbohydrate on liver fat or and the~     sources of intrahepatic fatty acids.~      A common polymorphism in PNPLA3 at rs738409 (adiponutrin) gene is associated with a markedly~     increase liver fat content. This finding has been replicated in at least 20 studies across~     the world. The investigators have shown that PNPLA3 is regulated by the carbohydrate response~     element binding protein 1. Mice overexpressing the human I148M PNPLA3 variant in the liver~     exhibit an increase in liver triglycerides and cholesteryl esters on a high sucrose but not~     high fat diet. These data suggest that overfeeding a high carbohydrate as compared to a high~     fat diet may increase liver fat more in subjects carrying the I148M allele than in~     non-carriers.~      B. HYPOTHESIS The investigators hypothesize that overfeeding a high fat as compared to an~     isocaloric high carbohydrate diet influences the source of intrahepatocellular triglycerides.~     During a high fat diet, relatively more of intrahepatocellular triglycerides originate from~     peripheral lipolysis and less from DNL than during a high carbohydrate diet in the face of a~     similar increase in liver fat. It is also possible given the lack of previous overfeeding~     data comparing 2 different overfeeding diets that the high fat diet induces a smaller~     increase in liver fat than a high carbohydrate diet even in the face of an identical increase~     in caloric intake because a greater fraction of ingested fat is channeled to adipose tissue~     than the liver. The investigators also hypothesize that liver fat may increase more in~     carriers than non-carriers of the I148M variant in PNPLA3 during a high carbohydrate than a~     high fat diet.~      C. SPECIFIC AIMS The investigators wish to randomize, using the method of minimization~     (considers baseline age, BMI, gender, liver fat, PNPLA3 genotype) 40 non-diabetic subjects~     with NAFLD as determined by the non-invasive score developed in our laboratory or previous~     knowledge of liver fat content based on MRS to overeat either a high carbohydrate or high fat~     diet (1000 extra calories per day) for 3 weeks. Before and after the overfeeding diets, will~     measure liver fat content by 1H-MRS and the rate of adipose tissue lipolysis using doubly~     labeled water (DDW) and [1,1,2,3,3-2H5] glycerol as described in detail below. The~     investigators also wish to characterize glucose, insulin, fatty acid and triacylglyceride~     profiles before and while on the experimental diet. An adipose tissue biopsy is taken to~     determine whether expression of genes involved in lipogenesis or lipolysis, or those involved~     in adipose tissue inflammation change in response to overfeeding, and for measurement of LPL~     activity. After overfeeding, both groups will undergo weight loss to restore normal weight as~     described in our recent study. The metabolic study is repeated after weight loss.~   "
109580|NCT02133131|"~     This is a study of grazoprevir (MK-5172) + elbasvir (MK-8742) and sofosbuvir (SOF) in~     treatment-naive participants with chronic hepatitis C (HCV) genotype (GT) 1 or GT3. The~     objective is to determine the proportion of participants achieving sustained virologic~     response 12 weeks after ending study treatment (SVR12).~   "
109581|NCT02133118|"~     Next to HbA1c, body weight is regarded as an important surrogate end-point in trials~     investigating glucose-lowering agents. An increase in weight could contribute to worsening~     insulin resistance. Differences in weight after starting glucose lowering agents have been~     described in many randomized controlled trials (RCTs).~      With this prospective observational study, weight trajectories after receiving add-on therapy~     next to metformin are evaluated in primary care patients with good glycaemic control.~   "
109582|NCT02133105|"~     Although inotropes have a favorable effect on central hemodynamics in patients with heart~     failure, their effect on renal hemodynamics is incompletely defined. The purpose of this~     study is to evaluate the efficacy of a 75 min intravenous infusion of levosimendan compared~     to a 75 min infusion of dobutamine on renal hemodynamics and function in patients with~     chronic heart failure and signs of cardiorenal syndrome. The investigators hypothesis is that~     patients treated with levosimendan will show greater increases in renal blood flow and~     glomerular filtration rate (GFR) than those treated with dobutamine.~   "
109583|NCT02133092|"~     The purpose of the study is to assess viral kinetics and clinical symptoms kinetics in~     pediatric patients hospitalized with Respiratory Syncytial Virus (RSV) confirmed lower~     respiratory tract infection (LRTI).~   "
109584|NCT02133079|"~     To evaluate the safety and effectiveness of autologous gp96 treatment of liver cancer and~     Pancreatic Adenocarcinoma~   "
109585|NCT02133066|"~     The reported rate of unsuccessful spinal taps in children, especially young infants, is high.~     Our hypothesis is that ultrasound assistance can improve the success rate of spinal taps.~   "
109586|NCT02133053|"~     This is a comparative, open label, parallel group, non interventional study to further~     demonstrate the effectiveness and tolerability of Ectoin® Allergy Nasal Spray. In addition~     the effectiveness and safety shall be compared to a Beclomethasone nasal spray. The patient~     applies Ectoin® Rhinitis Nasal Spray or Beclomethasone nasal spray according to the~     instructions for use. The observation takes place over a period of 14 days. Response to~     treatment is recorded at day 7 and day 14 by the physician and in daily by the patient in a~     dairy.~   "
109588|NCT02133027|"~     Objective:To explore the role of the right portal pedicle and Rouviere's sulcus as an~     anatomic landmark in laparoscopic cholecystectomy.~      Methods:The investigators are going to select 60 patients intending to perform Laparoscopic~     cholecystectomy from April 2014 to April 2015.Check out the presence of the right portal~     pedicle and Rouviere's sulcus during the surgery and divide into the experimental group and~     the control group.Experimental group operated in Laparoscopic cholecystectomy with the guide~     of Rouviere's sulcus while the Control group operated with the traditional way.~      Research hypothesis:Compare the differences between the Experimental group and the Control~     group in bile duct injury rate,complication rate,blood loss,operative time ,conversion rate~     and hospital stay.It is supposed that the results of Experimental group are superior to the~     control group,difference is statistically significant(P<0.05). So the investigators can draw~     the conclusion that the anatomy method with the guide of right portal pedicle and Rouviere's~     sulcus is useful in laparoscopic cholecystectomy.~   "
109589|NCT02133014|"~     The purpose of this study is to analyze the effect of laparoscopic-assisted percutaneous~     catheter drainage of early SAP(severe acute pancreatitis).We are going to select 60 cases SAP~     patients from April 2014 to April 2015 who carry on the treatment in our hospital,and divide~     into the experimental group and control group under respect the wishes of patient in the~     case.The experimental group use the method of laparoscopic-assisted percutaneous drainage to~     carry on the treatment,the control group patients use conventional conservative therapy to~     carry on the treatment.Contrastive analyze two groups of patients clinical care effects.~      Research hypothesis:according to compare the mortality,the incidence of complications~     ,hospital stay and other research indicators of two groups .It is supposed that the research~     indicators of experimental group are lower than the control group ,difference was~     statistically significant(P<0.05).We can draw the conclusion that the method of~     laparoscopic-assisted percutaneous catheter drainage of early SAP is useful and deserve to be~     promoted on clinical.~   "
109590|NCT02133001|"~     The purpose of this study is to evaluate the efficacy of intranasal esketamine 84 milligram~     (mg) compared with intranasal placebo along with standard care treatment, in reducing the~     symptoms of major depressive disorder (MDD) (an affective disorder manifested by either a~     dysphoric mood or loss of interest or pleasure in usual activities, the mood disturbance is~     prominent and relatively persistent), including the risk for suicide as assessed by the~     Investigator, in participants who will be assessed to be at imminent risk for suicide.~   "
109591|NCT02132988|"~     The purpose of this study is to evaluate the effect of OPT-822/OPT-821 on improving~     Progression-Free Survival (PFS) in subjects who have non-progressive epithelial ovarian,~     fallopian tube, or primary peritoneal cancer after cytoreductive surgery and platinum-based~     chemotherapy as initial treatment for primary disease or as salvage treatment for first~     relapse.~   "
109592|NCT02132975|"~     Study, for the first time in clinical conditions, the potential contribution, in terms of~     accuracy, of the motorised probe holder during prostate biopsies.~   "
109593|NCT02132962|"~     The study investigates the effect of aminoacid infusion on proteinturnover in muscle from~     cirrhosis subjects, compared to healthy controls.~      The hypothesis is that aminoacid infusion can attenuate the increase in proteindegradation~     that follows cirrhosis.~   "
109594|NCT02132949|"~     This multicenter, non-randomized, open-label, phase 2 study is designed to evaluate the~     safety and efficacy of pertuzumab (Perjeta) in combination with trastuzumab (Herceptin) and~     anthracycline-based chemotherapy as neoadjuvant treatment in participants with HER2-positive~     locally advanced, inflammatory, or early-stage breast cancer. Each investigator will choose a~     treatment regimen (A or B) for all of their participants to follow. Treatment regimen A (for~     Cohort A) will include dose-dense doxorubicin and cyclophosphamide (ddAC), followed by~     paclitaxel, with pertuzumab and trastuzumab given from the start of paclitaxel. Treatment~     regimen B (for Cohort B) will include 5-fluorouracil, epirubicin, and cyclophosphamide (FEC),~     followed by docetaxel, with pertuzumab and trastuzumab given from the start of docetaxel.~     Participants in both cohorts will subsequently undergo surgical treatment and then resume~     pertuzumab and trastuzumab treatment.~   "
109595|NCT02132936|"~     The purpose is to compare the efficacy of treatment with LEO 90100 at Week 4 to that of~     calcipotriol plus betamethasone dipropionate (BDP) gel at Week 8 in subjects with psoriasis~     vulgaris~   "
109596|NCT02132923|"~     The purpose of the study is to assess viral kinetics and clinical symptoms kinetics of~     Respiratory Syncytial Virus (RSV) in pediatric patients hospitalized with RSV confirmed lower~     respiratory tract infection (LRTI).~   "
109597|NCT02132910|"~     The purpose of the study is to learn about the effect of integrative therapies on chronic or~     recurrent low back pain.~      The intervention called RESTORE (Restorative Exercises for Strength Training and Operational~     Resilience) is based on a series of gentle stretching and strengthening exercises~     incorporating breath-work and mindfulness. The study is designed to discover the impact of~     RESTORE on pain levels, physical function, and behavioral health.~   "
109598|NCT02132897|"~     Controlled release Carbamazepine (CBZ) is a antiepileptic, antineuralgic and mood stabilizer~     drug. The CR formulation of CBZ is slowly absorbed and the elimination half life varies with~     time due to metabolism autoinduction.~      The primary objective of this study is to estimate the bioequivalence of the new brand~     generic product (Auration(R) CR) 400 mg manufactured in Uruguay vs. the innovative product~     (Tegretol(R) CR) 400 mg manufactured in Brasil, under fed conditions. The secondary objective~     will be evaluation of safety issues.~      The study design will be randomized two sequences, two periods and crossover. For a power of~     not less than 80% sample size was estimated to be 20 healthy male subjects. Products will be~     administered with food (high calories/high fat breakfast) after an overnight fast.~      Time vs. concentration curves will be built for each subject and formulation and Area Under~     Curve (AUC0240) will be estimated using the trapezoid rule, the AUC 0-inf. (from time 0 to~     infinity) will be estimated using the formula Cz/Ke, Cmax will be taken from the individual~     curves.~      This parameters will be statistically processed with the WinNonlin 6.3~     Pharmacokinetics/Statistic software in order to prove bioequivalence between the study~     products.~   "
109600|NCT02132871|"~     The primary purpose of this study is to investigate wether the measure of stroke volume (SV)~     variations by impedance cardiography during passive leg raising (PLR) can reliably predict~     preload dependency after cardiac surgery, in comparison to a reference parameter : velocity~     time integral (VTI) variation measured by transthoracical echocardiography.~   "
109601|NCT02132858|"~     This research trial studies genetic mutations in blood and tissue samples to see if they can~     be used to predict treatment response in patients with locally advanced rectal cancer~     undergoing chemoradiation. Studying samples of blood and tumor tissue in the laboratory from~     patients with cancer may help doctors learn more about genetic mutations or changes that~     occur in deoxyribonucleic acid (DNA) and help doctors understand how patients respond to~     treatment.~   "
109602|NCT02132845|"~     This randomized clinical trial studies how well next generation sequence target-directed~     therapy works in treating patients with cancer. Next generation sequencing is a test that~     screens for mutations to cancer related genes. Target-directed therapy is a type of treatment~     that uses drugs or other substances to identify and attack specific types of cancer cells~     that may have less harm to normal cells. Next generation sequencing may help identify these~     specific types of cancer cells.~   "
109603|NCT02132832|"~     This project has two primary goals. The first goal is to further scientific understanding~     about marijuana abuse by examining two recognized factors in marijuana use and relapse: (1)~     stress/anxiety and (2) atypical reactivity to marijuana-related stimuli (e.g., attentional~     bias). The second goal is to attenuate the influence of stress/anxiety and attentional bias~     to marijuana stimuli via administration of buspirone.~      Buspirone is uniquely suited to this project because it has effects on neurotransmitter~     systems known to modulate both stress/anxiety and attentional bias.~   "
109604|NCT02132819|"~     Necrotising enterocolitis (NEC) is a devastating picture that all the neonatologists are~     afraid of facing during the follow up of newborns. During the last years, investigators ran~     retrospective observational studies abut NEC developing within the 48 hours after red blood~     cell transfusion. In the previous studies, the incidence of transfusion associated NEC~     (TANEC) was found to be 20-35%.Multiple transfusions potentially cause an increased risk for~     retinopathy of prematurity (ROP) and NEC. Investigators have also proposed a hypothesis about~     transfusion related acute gut injury (TRAGI), an adverse reaction of transfusion, similar to~     transfusion related acute lung injury (TRALI) seen in adults.In most of the neonatology~     clinics, withholding feeds during transfusion is not preferred. But several recent studies~     show an increase in the incidence of TANEC if the newborn goes on feeding before, during and~     after the transfusion process, especially if it is fed with a formula. The main aim of this~     study is to investigate the effect of withholding feeds during transfusion, on the~     development of TRAGI.~   "
109605|NCT02132806|"~     The purpose of this study is to evaluate the effectiveness of piezosurgery in the treatment~     of class II furcation involvement using biomaterials and new surgical techniques~   "
109606|NCT02132793|"~     The immediate objective of this project was to demonstrate the feasibility of Remote~     Exercises for Learning Anger and Excitation Management (RELAX). The application is a remote,~     technology- enabled, anger treatment and management system based on current evidence-based~     CBT interventions. The project's objective was to show that RELAX (1) enables the practice of~     anger management strategies remotely through mobile phone interfaces; (2) integrates with~     evidence-based treatments through the implementation of an existing CBT anger management~     course; (3) provides information, direction, and feedback through physiological sensors and~     signal analysis; and (4) supports communication and direction by the therapist through a~     web-based therapist interface.~   "
109607|NCT02132780|"~     There is a significant association between autonomic dysfunction and symptoms experienced by~     NAFLD patients mediated by increased systemic inflammation and insulin resistance, resulting~     in deteriorating quality of life of affected patients; fatigue and other symptoms drive~     worsening autonomic dysfunction in these patients. We aim to describe the severity of~     autonomic dysfunction (AD) in non-alcoholic fatty liver disease (NAFLD) and the relationship~     of AD to symptoms experienced by NAFLD patients (such as fatigue, chronic pain, depression,~     sleep disturbance, and cognitive dysfunction), and to the quality of life of NAFLD patients.~     We also hope to examine the impact of systemic inflammation and insulin resistance as~     mediators of manifestations of AD and symptoms experienced by NAFLD patients.~   "
109608|NCT02132767|"~     The purpose of this study is to compare the therapeutic strategies of rate control versus~     rhythm control in cardiac surgery patients who develop in-hospital postoperative atrial~     fibrillation or atrial flutter (AF). In patients who develop AF during hospitalization after~     cardiac surgery, the hypothesis is that a strategy of rhythm control will reduce days in~     hospital within 60 days of the occurrence of AF compared to a strategy of rate control.~   "
109609|NCT02132754|"~     This is a 5-part dose-escalation study to determine the maximum tolerated dose (MTD)/maximum~     administered dose (MAD) of MK-4166 in participants with advanced solid tumors. In Part A,~     MK-4166 doses will be escalated quickly in successive cohorts and based on safety events may~     progress to Part B, in which the preliminary MTD will be identified. Based on safety events~     the study may progress to Part C in which the MTD will be confirmed. In Part D, participants~     will receive escalating doses of MK-4166 plus a fixed dose of pembrolizumab (MK-3475) 200 mg~     to determine the MTD for MK-4166 in combination with pembrolizumab. Based on safety events in~     Part D, the study may progress to Part E in which the MTD for MK-4166 in combination with~     pembrolizumab will be confirmed.~      With Amendments 05/06, the dose confirmation Part E (combination of MK-4166 and~     pembrolizumab) will be limited to participants with advanced malignant melanoma.~      The primary study hypotheses are that MK-4166 as a single agent and MK-4166 in combination~     with pembrolizumab have acceptable safety and tolerability.~   "
109610|NCT02132741|"~     Patients with high blood pressure (hypertension) and chronic kidney disease are at an~     increased risk of developing heart disease and strokes. Part of this risk is due to changes~     in the structure and function of the blood vessels throughout the body. It is thought that~     reducing high blood pressure and treating chronic kidney disease improves the structure and~     function of blood vessels but information on this is limited. Optical coherence tomography~     (OCT) is a method of looking at the blood vessels at the back of the eye. It is a simple,~     quick and non-invasive test that you may have previously had during a visit to the optician.~     The purpose of the study is to ascertain whether OCT is able to detect changes in the eye's~     blood vessels in patients with hypertension and chronic kidney disease compared to healthy~     individuals and also to see if any differences seen improve with treatment.~   "
109611|NCT02132728|"~     This study aims to evaluate the effects of enterolignanas of flaxseed on nutritional and~     inflammatory indicators in male workers of a food industry.~   "
109612|NCT02132715|"~     As the U.S. population ages and the prevalence of osteoarthritis (OA) among older adults~     rises, the prevention of OA-associated disability is an important public health priority.~     Accordingly, efficacious interventions are needed to manage pain and maintain physical~     function among older adults with OA. Because skeletal muscle weakness is a primary~     contributory factor to the progression of pain and functional decline among persons with OA,~     optimal interventions are those capable of improving skeletal muscle strength. High-intensity~     resistance exercise is the best-known method of improving muscle strength; however~     high-compressive loads typically induce significant joint pain among persons with OA.~     Accordingly, current recommendations include the performance of low- or moderate-intensity~     physical exercise - despite the fact that these training paradigms are sub-optimal for~     enhancing muscle strength. This application proposes conduct a pilot study to investigate the~     potential of an innovative training paradigm with potential to stimulate improvements in~     skeletal muscle strength while utilizing low-intensity loads. This paradigm, known as KAATSU~     training, involves performing low-intensity exercise while externally-applied compression~     mildly restricts blood flow to the active skeletal muscle. The overarching objective of the~     present application is to evaluate the efficacy and feasibility of chronic KAATSU training~     for the improvement of skeletal muscle strength and physical function among persons aged > 60~     years with symptomatic knee OA and mild to moderate physical limitations. Up to 72~     participants will be recruited to participate in this three month intervention study.~     Participants will be randomly assigned to one of two intervention conditions: (1) a standard~     exercise intervention consisting of center-based, moderate-intensity resistance training, or~     (2) a KAATSU training program matched for overall workload. This study will provide novel~     information regarding the therapeutic potential of KAATSU training for improving strength and~     function as well as attenuating pain among these individuals. The study will also provide~     critical information regarding the long-term, clinical viability of the paradigm by~     evaluating participant safety, discomfort, and willingness to continually engage in the~     KAATSU training program.~   "
109613|NCT02132702|"~     This study is to evaluate the performance attributes and user progression of participants~     with motor complete and incomplete spinal cord injury (SCI) while utilizing the Ekso robotic~     exoskeleton in an eight week over ground, locomotor program. We hypothesize an improvement in~     progression and overall health while using Ekso.~   "
109614|NCT02132689|"~     Currently there is no clear guidance for the treatment of moderate risk of pulmonary~     embolism. The aim of the study is to compare two different therapeutic modalities - standard~     anticoagulation versus thrombolytic treatment followed by anticoagulation in standard regimen~     as stated in the pulmonary embolism guidelines.~   "
109615|NCT02132676|"~     The purpose of this study is to evaluate the effectiveness of a peer-to-peer program (P2P) in~     addition to Shared Medical Appointments (SMAs) compared to SMAs alone for the treatment of~     diabetes in five VA health systems, and to study the implementation process in order to~     gather information required to disseminate the program more broadly in the VHA system.~   "
109616|NCT02132663|"~     This clinical trial will evaluate an investigational infant formula with an alternate source~     of DHA to determine if it provides normal growth and if it is well tolerated by term infants~     as compared to a marketed routine infant formula.~   "
109617|NCT02132650|"~     The VHA estimates that over 15,000 Veterans incur a stroke each year. As the population of~     older Veterans grows, stroke will become an increasingly important problem to the VHA.~     Recovery of walking function is the most common goal of stroke survivors. The proposed study~     will test whether training with accurate walking tasks to engage the damaged supraspinal~     motor pathways is more effective than training with steady state walking. The investigators~     expect that training accurate tasks will be more effective, thereby improving walking~     function of Veteran stroke survivors and reducing the burden of care placed on families and~     on the VHA. Furthermore, this rehabilitation approach can be accomplished at comparable cost~     to existing rehabilitation approaches, which is important given that the VHA invests $88~     million per year toward outpatient care, including physical rehabilitation, in the first six~     months after stroke. This research also has implications for rehabilitation of other~     neurologically injured populations, including traumatic brain injury and incomplete spinal~     cord injury.~   "
109618|NCT02132637|"~     The primary purpose of this study is to compare the effect of a double dose of a study drug~     known as insulin peglispro to a double dose of insulin glargine in participants who have type~     2 diabetes. Participants will be treated with study insulin daily, in two 4-week study~     periods. Each participant will receive insulin peglispro during one treatment period and~     insulin glargine during the other treatment period.~   "
109619|NCT02132624|"~     Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and~     efficacy in patients with B cell lymphoma or leukemia. The CAR consists of a CD19 targeting~     antibody scFv with three intracellular signaling domains derived from CD3 zeta, CD28 and~     4-1BB. Autologous T cells will be gene engineered with the CAR gene using a retrovirus~     vector. Prior to T cell infusion, the patients will be subjected to preconditioning~     treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse~     reactions, persistence of CAR T cells and efficacy.~   "
109620|NCT02132611|"~     The purpose of the COAST clinical study data will be to utilize and to gain approval for~     commercializing the Micro Crown as part of the Coronary Orbital Atherectomy System (OAS).~   "
109621|NCT02132598|"~     This is an open-label phase II clinical trial designed to allow a preliminary assessment of~     the efficacy and safety of cabozantinib in unselected Non-Small Cell Lung Cancer (NSCLC)~     patients with metastases to the brain and in the subset of patients with c-MET amplified~     Non-Small Cell Lung Cancer with metastases to the brain. Previously treated patients with~     non-squamous NSCLC who have had brain metastases at any point in their treatment history are~     eligible for enrollment on this clinical trial. Patients with clinically asymptomatic~     untreated brain metastases will be allowed on trial at the discretion of the treating~     investigator. Patients who have undergone treatment for their brain metastases with~     Whole-Brain Radiation Therapy (WBRT), stereotactic radiosurgery (SRS) or surgery must be~     clinically stable and recovered from all procedures at the time of study enrollment.~   "
109622|NCT02132585|"~     Speckle tracking (STE) is a novel echocardiographic technique which permits calculation of~     myocardial velocities and deformation parameters such as strain and strain rate (SR). It is~     demonstrated that these parameters provide important insights into systolic and diastolic~     function, ischaemia, myocardial mechanics and many other pathophysiological processes of the~     heart. In this preliminary study, we investigated the role of STE in detection of early~     ventricular dysfunction in patients with Sjogren Syndrome, focusing on cardiorespiratory~     fitness.~   "
109623|NCT02132572|"~     Retrospective multi-center, post-marketing study to evaluate the incidence and etiology of~     reoperations with Allergan Natrelle® Breast Implants in primary augmentation (RANBI)~   "
109638|NCT02132364|"~     The main objective of the study is to compare the benefit of optimised follow-up by nursing~     personnel from the vascular neurology department, including therapeutic follow-up and an~     educational program directed to the patient and a caregiving member of his social circle,~     with that of a typical follow-up.~   "
109624|NCT02132559|"~     Women with low ovarian reserve typically respond less well to the drugs used to stimulate the~     ovary during IVF treatment and produce fewer eggs and, as a result, are less likely to fall~     pregnant either naturally or after fertility treatment. The ideal stimulation regimen for~     poor responders is currently unknown.~      Dehydroepiandrosterone (DHEA) has been reported to improve pregnancy chances for poor~     responders, and is now utilized by approximately one third of all IVF centers world-wide.~     However, the current clinical evidence for DHEA on improvement of ovarian response and IVF~     outcome is insufficient. The validity of the results of the former studies, especially the~     varied inclusion criteria used to specify poor responders, is a subject of debate. Recently a~     uniform definition on poor ovarian response, the Bologna criteria, has been proposed by the~     European Society for Human Reproduction and Embryology(ESHRE). However, no studies have been~     performed study to evaluate the potential effects of DHEA supplementation according to these~     standards.~      The purpose of this study is to assess the impact of DHEA supplementation on IVF outcome of~     poor ovarian responders that fulfill the Bologna criteria.~   "
109625|NCT02132546|"~     The aim of this clinical trial was to evaluate through a clinical spectrophotometric analysis~     the staining side effect of a 0.2% CHX mouthwash containing an anti discoloration system~     (ADS) compared with a 0.12% and a 0.2% CHX alone mouthwash after periodontal surgery. The~     efficacy of the products and the patient's opinion and acceptance were also assessed.~   "
109626|NCT02132533|"~     The purpose of this study is to determine if nifedipine treatment of women in preterm labor~     receiving corticosteroids results in postponement of delivery when compared to placebo.~   "
109627|NCT02132520|"~     The purpose of this study is to determine whether the combination of low frequency repetitive~     transcranial magnetic stimulation (rTMS) and motor-imagery-based brain computer interface~     (BCI) training is effective for enhancing motor recovery after stroke.~      The PI's hypothesis is that, in comparison with traditional physical therapy alone, subjects~     receiving supplementary rTMS and BCI training will show greater functional improvements in~     hand motor ability over time as well as recovery of normal motor connectivity patterns.~   "
109628|NCT02132507|"~     The purpose of the study is to evaluate a new technology for functional neuroimaging using~     electroencephalography (EEG) and MRI in studying epilepsy.~   "
109629|NCT02132494|"~     The relationship between physical activity and academic performance has received widespread~     attention owing to the pressure on schools to graduate pupils who meet accepted academic~     standards. As important, there are global concerns regarding the increased prevalence of~     lifestyle-related non-communicable diseases (NCDs). First, Norway has a history of mediocre~     scores on international comparative academic performance tests such as Trends in~     International Mathematics and Science Study (TIMSS) and the Programme for International~     Student Assessment (PISA) [1]. It is therefore important to develop and evaluate strategic~     programs that may enhance pupil's academic performance. It is increasingly evident that a~     physical activity strategy that brings about enhanced cognitive function, better blood flow,~     and more, plays a key role in this effort [2]. Second, the prevalence of NCDs, such as~     diabetes mellitus type 2, is increasing worldwide, and such NCDs affect people of all ages~     [3]. Hence, healthcare costs are escalating to unaffordable levels. The best means to deal~     with this immense problem is through primary prevention, and physical activity is a powerful~     common denominator known to play a key role in preventing a host of NCDs [4].~      Consequently, both World Health Organization (WHO) and the Norwegian health authorities call~     for effective primary prevention strategies to promote physical activity in children and~     adolescents [5, 6]. Prop. 90 L (2010-2011) Act on public health work [6] emphasizes that~     physical activity in school can benefit both the learning process and public health~     prevention.~      Therefore, the objective of the ASK-study is to investigate the effects on academic~     performance of 60 minutes of daily physical activity during one school year. Furthermore, due~     to the complexity in the relationship between physical activity and academic performance, it~     is necessary to identify possible mediating and moderating variables as cognitive~     performance, quality of life (QoL), classroom behavior, motor skills and motivation. Also, we~     aim to investigate changes in risk factors related to NCDs and factors that influence NSDs,~     such as physical activity, sedentary behavior and health-related fitness.~      In addition a qualitative part of the ASK-Study will be conducted to get an in-depth~     understanding of the children's embodied experiences and the meaning of the social learning~     culture in school physical activity (PA). This will give us an in-depth description of the~     intervention context, offer insight in how the intervention possibly influences children's~     overall development and enables us to estimate potential long term effects of the~     intervention.~      If successful, the ASK cluster-randomized controlled trial (RCT) could provide much needed~     solutions to enhancing schoolchildren's academic performance and position the school as an~     effective setting for a massive public health intervention concerning the prevention of NCDs.~   "
109630|NCT02132481|"~     The primary goal of the proposed trial is to examine the effect of combining frequent~     self-monitoring via Ecological Momentary Assessment (EMAs) and automated interventions via~     Ecological Momentary Interventions (EMIs) provided by smartphone, on days of abstinence from~     drugs and alcohol and HIV risk behaviors over 6 months following treatment discharge. We will~     recruit 400 participants at discharge (both planned or unplanned) from Illinois' largest~     treatment organization and randomly assign them in a 2 x 2 factorial design to receive EMA~     only, EMI only, combined EMA+EMI, or neither (control). Participants in the 3 EMA and EMI~     groups will receive a smartphone and training after discharge. To help them self-monitor,~     individuals in the EMA groups will be randomly signaled 6 times daily for 6 months and asked~     to record their recent substance use, HIV risk behaviors (e.g., needle use, unprotected sex)~     and exposure to internal and external protective and risk factors, then to rate the extent to~     which these factors support their recovery or make them want to use drugs or alcohol.~     Individuals in the EMI groups will have 24/7 access to a smartphone recovery support system.~     In the combined EMA+EMI group, participants will receive feedback directly following~     completion of each 2-3 minute EMA, and EMA responses will be used to encourage EMI~     utilization. The primary hypotheses are~      H1 Random assignment to a) EMA (vs. not), b) EMI (vs. not), and c) their interaction will be~     associated with more days of abstinence from drugs and alcohol over the 6 months post~     discharge.~      H2 Random assignment to a) EMA, b) EMI, and c) their interaction will be a associated with~     fewer HIV risk behaviors over the 6 months post discharge.~      H3 Days abstinent at 3 months post discharge will mediate the effects of a) EMA, b) EMI and~     c) their interaction on HIV Risk behavior at 6 months post discharge.~   "
109631|NCT02132468|"~     This study will investigate the safety, symptoms and biomarker response of subjects with~     biopsy-proven well-differentiated, low-to-intermediate-grade, unresectable, or metastatic~     pancreatic neuroendocrine tumors (PNETs) or or Gastrointestinal Neuroendocrine tumors~     (GI-NETs) with elevated biochemical markers who have relapsed during or after receiving prior~     standard of care therapies, including octreotide, chemotherapy or targeted therapy.~   "
109632|NCT02132455|"~     The purpose of colonoscopy (colon examination with flexible tube and a camera) is to find~     early precancerous growth in the colon (polyps) and remove them before they turn into cancer.~     The doctor performing the procedure will first advance the colonoscope to the end of the~     colon (cecum) and then he will examine the colon for polyps while he is withdrawing the~     colonoscope. The period of time that the doctor spent examining the colon called withdrawal~     time. Usually doctors will spend at least 6 minutes examining the colon after he reached the~     cecum. The investigators are proposing that dedicating half of the withdrawal time during~     colonoscopy in examining the right side of the colon, will increase the detection of polyps~     in the right side of the colon.~   "
109633|NCT02132442|"~     This study is designed to study the effect of vitamin D intake on the severity of fatty liver~     and poor glucose control in patients with type 2 diabetes and fatty liver disease.~   "
109634|NCT02132429|"~     The primary purpose of this study is to evaluate the safety and tolerability of multiple oral~     doses of AMG 333 for 14 days in healthy subjects and migraine subjects. As part of the~     secondary objectives, the study will characterize the pharmacokinetic (PK) profile of AMG 333~     after multiple oral doses in healthy subjects and migraine subjects, as well as characterize~     the effect of multiple doses of AMG 333 on increases in blood pressure (BP) induced by the~     cold pressor test (CPT) in healthy subjects.~   "
109635|NCT02132416|"~     The purpose of this prospective controlled study is to determine whether surgical management~     of unstable thoracic cage injuries and chest wall deformity in trauma reduces the need for~     and the time spent on ventilator compared to a group treated without operation.~   "
109636|NCT02132403|"~     This Phase Ib dose escalation study will evaluate BTH1704, a monoclonal antibody that targets~     an aberrantly glycosylated antigen Mucin 1, and Imprime PGG, a glucan contained in yeast that~     is essential in triggering a leukocyte-mediated cytotoxic response towards tumor cells, in~     combination with gemcitabine in patients with advanced PDAC. The three intravenous drugs are~     taken in tandem 4 times in a 28-day cycle. The MAD of BTH1704 (BTH, 3 dose levels) in~     combination with gemcitabine (Gem) and Imprime PGG (I) will be determined using a standard~     3+3 design. Treatment continues until disease progression, unacceptable toxicity, physician~     discretion, or patient refusal.~   "
109637|NCT02132390|"~     Compare the potential benefits of adjuvant toremifene with or without goserelin in~     premenopausal women with stage I-IIIA, hormonal receptor positive breast cancer accompanied~     with or without chemotherapy induced amenorrhoea.~   "
126518|NCT01911455|"~     In this research study we want to understand the effectiveness of a drug treatment,~     acamprosate, for interfering symptoms (i.e., inattention/hyperactivity, social impairment)~     associated with Fragile X Syndrome (FXS).~   "
109639|NCT02132351|"~     Due to the limitations and the invasive nature of liver biopsy, there has been extensive~     interest in developing non-invasive tests to measure liver fibrosis (1). These are~     alternatives to liver biopsy that can be used in clinical practice, with benefits in terms of~     cost, risk, and patient convenience (2). Clinically applicable non-invasive tests include~     radiological studies, transient elastography (TE), and serum markers. We aim at studying~     acceptability, reliability, applicability and practical aspects of invasive and noninvasive~     methods for assessment of hepatic fibrosis and cirrhosis among hepatologists.~   "
109640|NCT02132338|"~     With health education, patients will have knowledge of the disease and may modify their~     attitudes to diabetes. Have a different behavior, will perform self-management of their~     health. Will adhere to physical activity, the better control of the disease and have quality~     of life. Empower the patient through the educational practices.~   "
109641|NCT02132325|"~     This study will evaluate feasibility and acceptability of providing the Dignity Therapy/Life~     Plan intervention to pancreatic or advanced lung cancer patients presenting for treatment in~     the outpatient medical oncology setting. Investigators hypothesize that providing dignity~     therapy to this population will be feasible.~   "
109642|NCT02132312|"~     The purpose of this study is to evaluate the effect of OMS302 compared to phenylephrine when~     administered in irrigation solution during cataract extraction on intraoperative pupil~     diameter, acute postoperative pain, and safety in children birth through 3 years.~   "
109643|NCT02132299|"~     This trial will evaluate whether relatively non-immune populations in endemic countries can~     effectively generate significant cellular and humoral immune responses that confer protection~     against P. falciparum infection after inoculation of aseptic, purified, vialed, metabolically~     active, non-replicating (live, radiation attenuated) Plasmodium falciparum sporozoites (PfSPZ~     Vaccine) administered intravenously (IV).~   "
109644|NCT02132286|"~     Major depressive disorder (MDD) is a highly prevalent, chronic and/or recurrent condition~     with substantial morbidity and mortality. It is one of the leading causes of disability~     worldwide. Despite significant advances in pharmacological treatment for depression over the~     last two decades, a significant proportion of patients (10-20%) are resistant to currently~     available treatment. The development of new effective treatment for depression is limited by~     the fact that MDD is a heterogeneous disorder with subgroups based on variations in~     etiological factors and treatment response. Functional magnetic resonance imaging (fMRI)~     approaches offer promise in the prediction and evaluation of clinical response of~     antidepressant treatment.~      Previous fMRI studies have identified increased activity in dorso-lateral prefrontal cortex~     (DLPFC) and decreased amygdala activity from the baseline as imaging markers of~     antidepressant response in patients with MDD. However, these studies have examined MDD as a~     homogenous group without specifying the type of patient group, and brain regions as a priori~     hypothesis.We therefore need studies using combined genetics and neuroimaging measures as~     biomarkers in the prediction and evaluation of clinical response to antidepressants. In this~     study we attempted to determine imaging clinical efficacy markers in previously defined brain~     regions (amygdala and prefrontal regions) for two classes of antidepressants (citalopram and~     quetiapine extended release (XR)) with differential action on serotonin transporter~     inhibition in a subgroup of MDD patients with high risk allele ( S/Lg) of serotonin~     transporter gene polymorphism.~   "
109645|NCT02132273|"~     The investigators hypothesize that use of an educational story with pictures illustrating~     overnight sleep study procedure (also called polysomnography or PSG)accompanied by simple~     narrative will be a cost-effective, readily accepted intervention that will contribute to~     successful completion of sleep studies among children with disabilities. Children who have~     been referred for a clinical sleep study at Kennedy Krieger Institute (KKI) will be enrolled~     and randomized to either recieve usual care (discussion of polysomnography with referring~     clinicians) or educational story intervention. Both groups of participants will be asked to~     complete questionnaries before and after the sleep study. Set-up for the sleep study will be~     videotaped so that behavior of the child can be evaluated. The investigators will evaluate~     whether successful study completion differs between the two groups.~   "
109646|NCT02132260|"~     The objective of this study is to compare the efficacy and safety of the test formulation of~     Naftifine Hydrochloride Cream 2% to Naftin® (Naftifine Hydrochloride) 2% Cream in a 6 week~     study in patients with tinea pedis.~   "
109647|NCT02132247|"~     The primary purpose of this study is to determine whether Flector Patch is safe for use in~     children. The secondary purpose is to assess blood levels of diclofenac, the active~     ingredient in Flector Patch.~   "
109648|NCT02132234|"~     The aim of this study is to evaluate the influence of anti tumor necrosis factor-alpha~     (TNF-α) treatment on blood pressure, endothelial function and immune cell phenotype in~     patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.~   "
109649|NCT02132221|"~     This research is being done to better understand how to help patients who are not receiving~     enough relief from opioid prescription medications for chronic non-cancer pain. Opioids are a~     group of medications that includes morphine, oxycodone-, hydrocodone-, etc. These medications~     are also called narcotics. Research has shown that patients not benefiting from their opioid~     prescription medication often feel better when they stop taking it. However, stopping or~     reducing pain medications can be a difficult transition. Although they do not have much~     benefit from their medication, many patients are afraid to stop because they feel these~     medications are the only things giving them a bit of relief. Different strategies can be used~     to help patients through the period of tapering and it is not clear which one is best. The~     investigators will test a specific approach used during regular care in the clinic: cognitive~     therapy.~   "
109650|NCT02132208|"~     A prospective single-centre non-comparative non-interventional open study has been designed~     to validate, in a target number of 100 trauma patients, the correlation between TICCS~     evaluated on the site of injury and thromboelastography made on a whole blood sample taken at~     the latest 30 min after patient's arrival in the resuscitation room.~      The aim of this study was to evaluate the capacity to discriminate trauma patients suffering~     from active bleeding and arly acute coagulopathy of trauma and needing Damage control~     resuscitation from those without this aggravating combination with a new purely clinical~     easy-to-measure pre-hospital score: the Trauma Induced Coagulopathy Clinical Score (TICCS).~   "
109651|NCT02132195|"~     In childhood nephrotic syndrome, the kidneys leak protein, causing body swelling and a~     variety of possible complications such as infection, blood clots, and kidney failure. The~     first-line treatment for nephrotic syndrome is corticosteroids. Many children respond to~     prednisone treatment, but the disease comes back (relapses) when the prednisone is stopped or~     the dose is reduced. Children with frequently relapsing or steroid dependent nephrotic~     syndrome are at risk for toxicity from frequent exposure to corticosteroids.~      Currently, the standard treatment for frequently relapsing and steroid dependent nephrotic~     syndrome involves a variety of medications that suppress the immune system, which can produce~     serious side effects. We propose a study to examine the effects of a different medication,~     ACTH, on nephrotic syndrome. ACTH is a hormone naturally found in the body. Recently, in~     adult studies, ACTH has been shown to be effective for the treatment of nephrotic syndrome.~     It has also been shown to have mild and reversible side effects. ACTH is potentially an~     attractive therapeutic alternative for the treatment of frequently relapsing and steroid~     dependent nephrotic syndrome in children. Our study will randomly assign patients with~     frequently relapsing or steroid dependent nephrotic syndrome to either ACTH treatment or no~     treatment. This will allow us to study the effects of ACTH on this disease and its side~     effects, by comparing how patients do on ACTH treatment versus no treatment. We hypothesize~     that ACTH gel is superior to no treatment in maintaining remission in children with~     frequently relapsing or steroid dependent nephrotic syndrome.~   "
109652|NCT02132182|"~     The purpose of this study is to identify phenotypic (cell surface receptor expression) and~     functional differences in monocyte populations in humans with osteosarcoma as compared to~     published historical data on normal human monocyte values.~      The biologic similarity between canine and human osteosarcoma makes it a disease model that~     holds promise for translational research possibilities. The phenotypic and functional~     differences the investigators expect to find in canine and human monocytes between normal and~     osteosarcoma subjects in this pilot work will allow us to launch a program of investigations~     to further their understanding as to what characteristics are associated with improved~     survival in canine and human osteosarcoma. Such data will represent the foundation upon which~     the investigators can plan future investigations designed to exploit the potential anti-tumor~     capabilities of monocytes and macrophages in canine and human osteosarcoma.~   "
109653|NCT02132169|"~     The purpose of this study is to evaluate the safety of AC-170 0.24% used twice daily in~     Healthy Adult Subjects and in Pediatric subjects with a history or family history of atopic~     disease (including allergic conjunctivitis).~   "
109654|NCT02132143|"~     The purpose of this study compares chemoradiation and sequential chemoradiation about Lung~     adenocarcinoma patients with postoperative in pN2 and then determines which therapeutic~     method is better for the patients.~   "
109655|NCT02132130|"~     The goal of the study is to evaluate the safety, tolerability, and the potential ability of~     CGF166 delivered through IL-infusion to improve hearing. CGF166 is a recombinant adenovirus 5~     (Ad5) vector containing a cDNA encoding the human Atonal transcription factor (Hath1).~   "
109656|NCT02132117|"~     This study will evaluate the safety and efficacy of oxymetazoline hydrochloride (HCl) cream~     1.0% (AGN-199201) once daily compared to vehicle for the treatment of persistent moderate to~     severe facial erythema associated with rosacea.~   "
109657|NCT02132104|"~     The purpose of the study is to evaluate whether human amnion graft reduces the reformation of~     severe intrauterine adhesions (IUA) following hysteroscopic adhesiolysis.~   "
109658|NCT02132091|"~     Healthy volunteers will be recruited to participate in a ten-week double-blinded crossover~     trial. The trial will consist of two, three-week periods of intermittent fasting, where~     subjects receive either antioxidant supplementation or placebo, the ordering of which will be~     randomly determined. A one-week preconditioning will precede each invention period, and a two~     week wash-out period will follow the first intervention period. Serum-based assays will be~     performed to assess levels of reactive oxidant species, antioxidant genes, sirtuins, and~     markers of mitochondrial biogenesis and aging.~      The investigators hypothesize that an intermittent fasting diet in healthy young volunteers~     will improve these markers of cellular aging and that these beneficial effects will be~     abrogated by the supplementation of antioxidants. This study is a proof-of-principle study~     that will shed light on the mechanism and effects of IF as an anti-aging dietary intervention~     in the absence of weight loss. It will inform the design of dietary interventions that are~     both effective in improving markers of aging and feasible for patients to practice on a~     long-term basis.~   "
109659|NCT02132078|"~     The purpose of this study is to assess incidence, treatment modalities and outcome of~     complicated and uncomplicated diverticulitis in highly immunosuppressed lung transplant~     recipients (LTRs) in order to establish improved treatment strategies in this high risk~     patient collective.~   "
109660|NCT02132065|"~     Unilaterally Dual TAP (Transversus abdominis plane) block after radical nephrectomy,~     assessment of benefit and opioid reduction.~      Transverses Abdominal Plane (TAP) Block is a relatively new regional technique which~     infiltrates local anesthetic between the internal oblique and transverse abdominis muscles~     and provides analgesia to the parietal peritoneum as well as the skin and muscles of the~     anterior abdominal wall (1). An Ultrasound-guided bilateral dual transversus abdominis plane~     block (Dual TAP block) had been reported by Boerglum et al (2,3), in which regional~     anesthesia postoperatively can be provided to the upper (Th6-Th9) and the lower (Th10-Th12)~     abdominal wall bilaterally using a four-point single-shot technique.~      Pain has a wide spectrum of effects on the body. Inadequately controlled postoperative pain~     may have harmful physiologic, psychological consequences which potentially increase the~     morbidity and mortality (4,5). It has been recognized that inadequately treated postoperative~     pain may lead to chronic pain which is often misdiagnosed and neglected (6,7). Chronic~     postsurgical pain reported in 20% of patients, 6 months after nephrectomy (8).~      Hypothesis: The use of unilaterally dual TAP block will reduce the VAS score for pain and the~     need of morphine postoperatively after radical nephrectomy.~      Purpose: To evaluate the analgesic efficacy of unilaterally dual TAP block as an adjuvant to~     routine analgesic. To assess the difference in morphine usage in the first 48 hours after~     radical nephrectomy with or without applying of unilaterally dual TAP block.~   "
109661|NCT02132052|"~     Investigators hypothesize that there are specific characteristic of each cognitive and motor~     condition that can be defined using brains scans.~   "
109662|NCT02132039|"~     The study aims to compare the efficacy of a home-based structured exercise programme (12-step~     sitting Tai Chi) involving both persons with dementia and their caregivers with a standard~     non-exercise social contact control in treating depression among caregivers. The effects of~     exercise on their cognition, quality of life and balance ability are also assessed. We will~     also examine if BDNF polymorphisms modulate mood changes in response to exercise~     intervention. Focus groups will be organised at the end to find out the facilitators and~     barriers in taking up exercise. The findings may offer an avenue of intervention by providing~     a low cost, relatively safe and effective treatment for dementia caregivers, which may in~     turn benefit the persons with dementia.~   "
109663|NCT02132026|"~     Aortic stenosis is a condition whereby one of the heart valves (aortic valve) becomes~     narrowed, due to calcium deposition, over time. This can lead to chest pain, heart failure~     and sudden death. It is the commonest valve disease requiring surgery in the developed world~     and as the population becomes increasingly older, it is predicted that the prevalence of~     aortic stenosis will double in the next 20 years. Currently the only treatment is replacement~     of the aortic valve. Whilst this is excellent treatment, not everyone is suitable for it.~      The primary objective of our study is to determine whether 2 drugs used in the treatment of~     osteoporosis (a condition of bone thinning) can halt/retard the progression of aortic~     stenosis. This is on the basis that studies have suggested that altered regulation of calcium~     metabolism may be an important mechanism perpetuating the disease. Both drugs work by~     reducing calcium release into the bloodstream from bones and therefore calcification of the~     aortic valve.~      150 patients will therefore be randomly allocated to either of the trial drugs which are~     denosumab,the bisphosphonate (alendronic acid), or a placebo.~      Positron Emission Tomography (PET) scanning is a technique where biochemically active~     molecules are injected and are taken up at sites of ongoing calcification activity where they~     emit radiation and can be detected by the PET scanner. We have previously shown that this~     technique can demonstrate areas of newly developing calcification on an aortic valve.~      We therefore propose that patients receiving bisphosphonates or denosumab will have reduced~     evidence of active calcification and slower progression of their disease at two years as~     assessed by Echocardiography (ultrasound) and a change in their calcium score (quantity of~     calcium on the aortic valve measured using Computed Tomography [CT] ).~      The data from this study will then be used to design a larger trial.~   "
109664|NCT02132013|"~     The purpose of this study is to evaluate the effects and efficacy of dietary sodium~     restriction by mean of a new healthcare approach in patients with chronic kidney disease. The~     test persons in the intervention group are actively supported to adhere to a restricted~     sodium diet with a structured self-regulation program to implement sodium recommendations~     that are in current guidelines.~   "
109665|NCT02132000|"~     In premenopausal women, endocrine adjuvant therapy for breast cancer primarily consists of~     tamoxifen alone or with ovarian suppressive strategies. Toremifene is a chlorinated~     derivative of tamoxifen, but with a superior risk-benefit profile. In this trial, we sought~     to compare the efficacy and tolerability of toremifene and tamoxifen therapy in premenopausal~     patients with operable,estrogen and/or progesterone receptor positive breast cancer patients.~   "
109666|NCT02131987|"~     Between January 1 2006 and December 31 2013, at our department 324 patients underwent~     hemiarthroplasty (HA) for displaced femoral-neck fracture with a bipolar prosthesis~     (Variokopf, Link®, Germany) by the use of the posteriolateral approach. Patients with~     pathological fractures and HA performed with direct lateral approach were excluded. A~     retrospective cohort study were conducted. Patients with prosthetic dislocation formed one~     group and patients without dislocation formed the control group.~      As standard, post surgery radiographs (anteroposterior and lateral) were taken. After these~     were performed patient started weight bearing as soon as possible. Clinical data regarding~     patient demographics, details of the surgical procedure and the medical comorbidities were~     collected by the use of patient and operative records. Radiological analysis with position~     evaluation was performed using the post surgery radiographs by measuring Wiberg angle,~     inequality of leg length and femoral offset of the prostheses and compared with non-operated~     hip joint using the post surgery x-ray images.~      Our hypothesis were that patients with single- or recurrent dislocations had shortened~     postoperative leg length, decreased femoral offsed and a Wiberg angle less than 25 degrees.~   "
109667|NCT02131974|"~     The purpose of this research study is to help determine if the cuff of an endotracheal tube (~     ETT) ( also known as a breathing tube)can be seen by ultrasound and to determine if~     visualization of this tube corresponds with correct tube depth. You are being asked to~     participate because you will be undergoing a cardiac catherization procedure which will~     involve endotracheal intubation.~      Ultrasound is a safe technology that your doctor could possibly use to see the breathing~     tube. Right now, x-rays, which come with their own risks, are being used for this purpose. We~     are trying to see if we can avoid using x-rays.~      This is a local study with 1 location. The study will enroll a total of 71 people. There is~     no sponsor for this study.~   "
109668|NCT02131961|"~     This study is designed to evaluate the ability to modify a contact cast system so that~     topical medications can be applied daily to an underlying wound in patients with diabetic~     plantar ulcers. The modification of the cast will be done by making an opening where the~     wound is located in the contact cast system. A contact cast system is a device that will~     reduce the pressure in the area where the wound is located.~   "
109669|NCT02131948|"~     It is well known that the hormone insulin lowers blood glucose in part by acting directly on~     the liver and reducing hepatic glucose production. Animal studies have shown that the hormone~     insulin can act on the brain to indirectly lower glucose production by the liver. We aim to~     test whether this is true in humans by giving insulin intranasally. It has previously been~     shown that a nasal spray can deliver insulin directly to the brain without affecting~     circulating insulin concentration.~   "
109670|NCT02131935|"~     The investigators assessed the hypothesis that whether RH-PAT index (RHI) as a marker of~     endothelial dysfunction could predict occurrence of ISR after percutaneous coronary~     intervention (PCI).~   "
109671|NCT02131922|"~     Hypertensive patients with chronic periodontitis will be randomized to either intensive~     treatment or supragingival hygienic treatment and the effects on blood pressure will be~     identified.~   "
109672|NCT02131909|"~     This is a randomized and comparative prospective test, monocentric and controlled (mirror~     therapy versus bimanual rehabilitation exercises), in single-blind (investigator and~     occupational therapist  1  do not know the type of rehabilitation performed).~   "
109685|NCT02131740|"~     This study addresses the research question:~      How does eye rubbing affect corneal (clear part of eye) parameters in healthy volunteers~      The study objectives are:~        1. To determine the corneal changes following eye rubbing~        2. To assess tear film changes following eye rubbing~        3. To investigate if there is an association between eye rubbing and axial length of the~          eye.~   "
109673|NCT02131896|"~     Nutritional therapy has a major role in diabetes care, achieving and maintaining metabolic~     control: normal glucose homeostasis, normal lipid profile, normal blood pressure and~     desirable weight. Controlled nutritional diet, as introduced by the professional committees~     aims at achieving better general health condition.~      There is a growing body of evidence showing that Mediterranean diet has a major role in~     prevention of diabetes sequelae in type 2 diabetes patients. Hitherto, the effects of~     Mediterranean diet on patients with type 1 diabetes has not been studied, with the exception~     of one Italian study.~      Six months after education to consume Mediterranean diet in a cohort of 96 children with type~     1 diabetes the authors observed decreased fat and cholesterol consumption, increased dietary~     fiber consumption, lower LDL cholesterol levels and better HDL to LDL cholesterol ratio.~      The proposed study is aimed to assess the impact of Mediterranean nutrition compared to the~     accepted nutritional guidelines, in newly diagnosed type 1 children and adolescents on lipid~     profile, metabolic control, C peptide, daily insulin dose, Inflammatory parameters,~     endothelial function and anthropometric parameters 12 months following diagnosis.~      The study designed as a two parallel arms, randomized, single center, intervention study.~      Patients enrolled to the study will be randomly assigned, to one of the following groups in a~     1:1 ratio. Interventional Arm: Patients assigned to the interventional arm will receive~     nutritional instructions of Mediterranean diet and Control Group: Patients assigned to the~     interventional arm will receive regular nutritional instructions in accordance with the~     accepted nutritional guidelines~   "
109674|NCT02131883|"~     Background:~      The prevalence of severe health anxiety is reported to be 1-2% in Western communities. This~     functional disorder is difficult for medical doctors to treat, the course of the disorder is~     often chronic, and that is costly for the social and health care systems as well as for the~     patients. A Cochrane metaanalysis from 2009 finds evidence for effectiveness of individual~     cognitive behavior therapy (CBT) for patients with hypochondriasis. But no randomised~     controlled trials (RCT) of the effectiveness of classical CBT delivered only in groups for~     patients with severe health anxiety (hypochondriasis/illness anxiety disorder) has yet been~     conducted.~      Aims:~      1) to examine the effectiveness of group-CBT for patients with severe health anxiety compared~     to a wait-list group receiving usual care, 2) to perform a categorical and dimensional~     assessment of personality, 3) to examine predictors of outcome especially comorbid~     personality disorders, 4) to examine the relation between personality, illness perception and~     treatment outcome, 5) to compare the cost-effectiveness of these two treatments, 6) at a 2~     years follow up to examine the course and long-term effectiveness of group-CBT for patients~     with severe health anxiety and some also followed by psychological treatment for comorbid~     personality disorders.~      Main hypothesis:~      Patients with severe HA who have received group CBT will at 6-month follow-up compared to a~     wait-list group receiving usual care show a significantly reduction in health anxiety.~      Methods:~      84 patients referred from medical doctors during 2014-15 to the Clinic of Liaison Psychiatry~     in Koege, Region Zealand, Denmark, will be included and block randomised per 14 patients to~     either weekly group-CBT with 7 patients and 2 therapists for 3 hours a week in 12 weeks or~     wait-list with usual care for 9 months.~      Inclusion: Severe health anxiety (dominant mental disorder), score on WI-7>21,4, age 18-65~     years, Danish speaking, informed consent.~      Exclusion: Another severe treatment demanding mental disorder, risk of suicide or psychosis,~     a serious somatic disease, pregnancy, dependency of drugs, alcohol or medication.~      Diagnostic assessment:~      The patients are included using research criteria for severe health anxiety (for ICD-11) and~     semi-structured interviews developed for DSM-IV, SCAN (general psychopathology) and SCID-II~     (personality disorders). Criteria for hypochondriasis from ICD-10 and illness anxiety~     disorder/somatic symptom disorder from DSM-5 are used for subcategorising. Dimensions and~     traits of personality are assessed by the questionnaire PID-5 included in DSM-5, section III.~      Outcome measures:~      The primary outcome measure is the questionnaire for health anxiety, Whiteley Index 7 (WI-7),~     with a cut-off for remission on 21,4 or a blinded diagnostic assessment of no severe health~     anxiety present 6 months after end of treatment.~      The secondary outcome measures are questionnaires for health anxiety (HAI), general~     psychopathology (SCL-90-R), level of personality disorders (PID-5), level of functioning~     (SF-36), quality of life (WHO-5, EQ-5D), Illness perception (IPQ), alcohol consumption (CAGE)~     and register data for number of sick days and use of social and health care and a blinded~     global assessment of functioning (F-GAF).~      Time frame:~      Data wil be analysed, and results wil be disseminated from 2016.~   "
109675|NCT02131870|"~     The purpose of this study is to study the effect of a probiotic product on iron absorption in~     healthy females of child-bearing age.~   "
109676|NCT02131857|"~     Hypothesis 1: Mindfulness is a feasible tool for use within a cystic fibrosis (CF) clinic~      Hypothesis 2: Participants in the mindfulness intervention will show an increased level of~     quality of life post intervention with the Mindfulness course~      Hypothesis 3. Levels of mindfulness:~      Participants in the mindfulness intervention will report increased mindfulness levels~     post-program completion as compared to pre-program completion~      Hypothesis 4. Levels of stress:~      Participants in the mindfulness intervention will report lower levels of stress post-program~     completion as compared with pre-program commencement.~      Hypothesis 5. Levels of residual depressive symptoms post-mindfulness intervention program:~     Residual symptoms of depression are a risk factor for relapse of depression. Post -program~     participants of mindfulness will purport fewer residual depressive symptoms compared with~     pre-program.~      Hypothesis 6. CF is associated with severe neutrophilic inflammation of the airways. As~     mindfulness intervention has been shown to modulate immune system it may improve physical~     aspects of CF including markers of inflammation and markers of lung disease (lung function~     tests and rate of pulmonary exacerbations) and nutritional state.~   "
109677|NCT02131844|"~     Early mobilization (i.e. initiation of out of bed activities from the day of surgery) is~     considered an important component of postoperative care after colorectal surgery. Having a~     health professional dedicated to facilitate early mobilization has the potential to enhance~     postoperative recovery by preventing the negative effects of prolonged bed rest (e.g.~     increased risk for complications, muscle loss, deconditioning and functional decline);~     however, the need to implement this resource-intensive approach is not evidence based. This~     study aims to contribute evidence about the role of facilitated early mobilization as a~     strategy to enhance recovery after colorectal surgery.~   "
109678|NCT02131831|"~     There are several factors that influence telomere length in patients with cirrhosis, such as~     metabolic derangements and infectious etiologies, The aim of the study is to compare telomere~     length and other parameters related to genetic instability in telomere/ telomerase system, in~     peripheral blood lymphocytes in cirrhosis from different etiologies.~   "
109679|NCT02131818|"~     The purpose of this study is to determine amoxicillin is effective in the prevention of wound~     infection in normal labor.~   "
109680|NCT02131805|"~     The purpose of this study is to assess the effectiveness of electronic skin surface~     brachytherapy (ESSB) for early stage basal or squamous cell carcinoma of the skin using a new~     device. This new device is Nucletron's Esteya Electronic Skin Surface Brachytherapy System.~     The investigators want to understand what effects, good and/or bad this device for delivering~     brachytherapy has on your skin cancer. The investigators also want to assess the safety,~     cosmetic results, the effects that ESSB has on quality of life and to correlate skin imaging~     with clinical response to ESSB.~   "
109681|NCT02131792|"~     This study was conducted to evaluate results of slanted recession of the lateral rectus~     muscle for intermittent exotropia with convergence weakness~   "
109682|NCT02131779|"~     The objective of the Prostate Cancer Education in African American Churches project is to~     develop and evaluate a spiritually-based educational intervention for Informed Decision~     Making (IDM) for prostate cancer screening to be delivered to African American men in church~     settings.~   "
109683|NCT02131766|"~     The purpose of this study is to use the USS Virginia Closed-Loop system for overnight insulin~     delivery in adults with Type 1 Diabetes (T1DM) in an outpatient setting to evaluate the~     system's ability to significantly improve blood glucose levels. This protocol will test the~     feasibility of bedside closed-loop control - an approach comprised of standard~     sensor-augmented pump therapy during the day using off-the-shelf devices and overnight~     closed-loop control using experimental devices in an outpatient setting. The rationale for~     this study is as follows: we anticipate that closed-loop control may ultimately be adopted by~     patients with T1DM in a selective manner. Patient may choose to start using these systems for~     overnight control only, e.g. to alleviate the well documented fear of hypoglycemia while~     asleep. To test this paradigm of bedside closed-loop control, subjects will be studied with~     continuous glucose monitoring (CGM)-augmented usual pump therapy during the day followed by~     overnight use of USS Virginia Closed Loop Control.~   "
109684|NCT02131753|"~     The trial will test the effectiveness and toxicity of subcutaneous treatment with one cycle~     of cladribine in patients with hairy cell leukemia requiring treatment.~      They have to be untreated so far or may be pretreated with alpha-interferon.~   "
109686|NCT02131727|"~     The purpose of this study is to determine if a simple intervention to improve hand hygiene,~     consisting of a 3-4 minute training video, on-site posters, and hand hygiene supplies, can~     reduce respiratory and GI illness among employees.~   "
109687|NCT02131714|"~     Pain is an unpleasant sensory and emotional experience that is one of the main symptoms of~     temporomandibular disorder (TMD). One way to assess pain is through algometry. The aim of~     this study was to evaluate, by the pressure pain threshold measurements, the efficacy of a~     short-term conservative treatment for the management of temporomandibular disorders. This~     study is a randomized controlled clinical trial where 84 participants were diagnosed with~     myofascial pain according to the Research Diagnostic Criteria for Temporomandibular Disorders~     (RDC/TMD), with a mean age of 44 years old ranging from 18 to 76 years old. These individuals~     were asked about parafunctional habits and the treatment was applied by providing an~     explanation concerning the role of pain, possible aetiological factors of the patient's TMD,~     the relationship between chronic pain and psychosocial distress, and its benign character.~     They also had to perform once daily application of hot packs on both sides of the face for 20~     minutes and after that they must perform active free therapeutic exercise of mouth opening~     for 10 times. The pressure pain threshold of the masseter and temporalis muscles and the~     lateral pole of the condyle were obtained at baseline (T0), between 15 and 30 days after (T1)~     and at 75 to 90 days after (T2) representing the end of the treatment. Two groups of subjects~     were obtained. The first was considered the study group (SG) and included those who underwent~     the treatment proposed. The control group (CG) consisted of participants who did not undergo~     treatment because they did not believe in it.~   "
109688|NCT02131701|"~     The aim of the study is to evaluate the long-term effects of a prescription of exercise~     versus a group-based training program on aerobic fitness, muscle strength and metabolic~     variables in subjects with poor physical fitness. The participants are further stratified for~     a family-history of type 2 diabetes. The number of subjects in each group of intervention is~     planned to be 150, aged 30-70 years and non-diabetic.~      Intervention: All study subjects take part in two individual sessions for exercise~     prescription aiming at moderate exercise of 30 minutes at least 5 days a week. The~     prescription group perform exercise by themselves, while the training group will be offered~     supervised physical training, including both endurance training and training in gym twice a~     week during 12 months.~      The subjects will be followed up at 1, 2, 3 and 5 years after the basal visit.~      Methods of follow-up: At the study visits physical fitness will be measured by a 2 km walking~     test, glucose tolerance by oral glucose tolerance test with measurement of glucose and~     insulin. Lipids will be measured. Questionnaires will be used to follow lifestyle, physical~     activity, cardiovascular disease and medication.~      In the training group 30 subjects with and 30 subjects without a family history of type 2~     diabetes will participate in a sub-study including muscle- and fat-biopsy before the start of~     the study, after 1 and 5 years.~   "
109689|NCT02131688|"~     The purpose of this study is to determine the maximum tolerated dose,the safety and~     effectiveness of Mitoxantrone Hydrochloride Liposome Injection.~   "
109690|NCT02131675|"~     Background Type 1 diabetes is characterized by pancreatic beta-cell destruction and an~     inability to synthesize insulin. Connecting peptide (C-peptide) is formed from the same~     precursor as insulin and is produced in equimolar amounts as insulin. There are several~     clinical trials currently being performed to explore the possibility of beta-cell~     preservation or regeneration. Most children are not eligible for these trials because it is~     often presumed that C-peptide levels will decrease and become undetectable after years of~     having type 1 diabetes. Several studies in the adult population have demonstrated that~     C-peptide may remain measureable in patients who have had diabetes for up to 50 years after~     diagnosis. Recently, it was demonstrated that 10% of adult patients who have had type 1~     diabetes for 31-40 years have measureable levels of serum C-peptide if measured with an~     ultrasensitive assay. The levels were lower in patients who had diabetes for a longer time.~     This pattern was also demonstrated in the Diabetes Control and Complications Trial (DCCT) and~     NHANES trial. No studies have been performed exclusively in pediatric patients Hypothesis The~     investigators hypothesize that C-peptide should be detectable in the sera of pediatric~     patients who have had type 1 diabetes for greater than 1 year and as far out as > 20 years~     after diagnosis. The investigators also hypothesize that since their patient population has~     had diabetes for less time as compared to adults, the levels of C-peptide should be higher~     than reported for adults and that a greater proportion of patients in the pediatric~     population will have detectable C-peptide levels as compared to adults.~   "
109691|NCT02131662|"~     The study is performed to assess the efficacy and safety of different doses of BAY1002670 in~     subjects with uterine fibroids. The dose-response relationship will be evaluated. Further,~     the study aims to establish a population pharmacokinetic/pharmacodynamic relationship for~     BAY1002670 in subjects with uterine fibroids. To assess the efficacy of BAY1002670 the~     interchangeability of menstrual pictogram and alkaline hematin method for the judgement of~     menstrual blood loss will be assessed.~   "
109692|NCT02131649|"~     The PROPS trial is for men being considered for radiotherapy due to the suspicion that their~     prostate cancer has recurred following the surgical removal of their prostate~     (prostatectomy). This suspicion is based on rises seen on Prostate Specific Antigen (PSA)~     blood tests. Only men who demonstrate the absence of disease on standard imaging scans~     (Computed Tomography (CT) and bone scans) will be invited to participate.~      This study will be assessing if the imaging probe 18-F Fluorocholine (18F-FCH) used during~     Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI) scans, can better~     predict who will benefit from radiotherapy by identifying the source of cancer recurrence.~     This will be determined by measuring the number of men who have disease identified outside of~     the prostate bed (the small pocket or depression where the prostate used to be) on their~     18F-FCH PET scan. Since F-18-FCH has been shown to be more sensitive in detecting prostate~     cancer that may have spread into lymph nodes or bone, it may potentially identify areas of~     prostate cancer spread not seen with standard imaging.~   "
109693|NCT02131636|"~     This study will evaluate the safety and efficacy of AGN-199201 once daily compared to vehicle~     for the treatment of persistent moderate to severe facial erythema associated with rosacea.~   "
109694|NCT02131623|"~     The purpose of the study is to validate the ItchRO instrument (a clinical outcome assessment~     measure of itching) prior to the analysis of longitudinal treatment effect data being~     generated in ongoing clinical trials.~   "
109695|NCT02131610|"~     Changes in epigenetic regulation of genes involved in systemic inflammation and metabolic~     dysfunction in OSA are linked with accelerated cardiovascular morbidity.~   "
109696|NCT02131597|"~     The goal of this clinical research study is to learn if SGI-110 can help to control MDS. The~     safety of this drug will also be studied.~      This is an investigational study. SGI-110 is not FDA approved or commercially available. It~     is currently being used for research purposes only.~      The study doctor can explain how the study drug are designed to work.~      Up to 103 patients will take part in this study. All will be enrolled at MD Anderson.~   "
109697|NCT02131584|"~     The goal of this clinical research study is to learn if Jakafi (ruxolitinib) can help to~     control fatigue and other symptoms in patients with CLL who do not need treatment for the~     cancer. Researchers also want to learn if ruxolitinib can decrease the size of enlarged lymph~     nodes and/or lower the number of CLL cells in the blood.~   "
109698|NCT02131571|"~     Prospective cohort study to determine the prevalence of vertebral fractures in HIV infected~     patients older than 50 years.~   "
109699|NCT02131558|"~     Patients with endometrial cancer who have planned robotic laparoscopic hysterectomy and full~     bilateral pelvic and para-aortic lymphadenectomy will receive injections of a fluorescent~     dye, Indocyanine green (ICG). ICG spreads through the lymphatic system, and will be~     visualized using near-infrared (NIR) imagers. Upon visualization of the path of the ICG,~     sentinel lymph nodes (SLNs), the first nodes to receive drainage from the primary tumor, will~     be identified. SLNs will be surgically removed and provided to Pathology for evaluation.~     Non-sentinel nodes will also be surgically removed, as is consistent with routine medical~     care for these patients, and given to Pathology for evaluation. A positive SLN may be the~     most accurate identifier of the extra-uterine spread of disease, and will provide information~     about the extent of surgical node removal necessary.~   "
109700|NCT02131545|"~     Quetiapine, a second generation antipsychotic, is only available as oral tablets. However,~     topical and rectal formulations have been produced in compounding pharmacies. There is no~     data available suggesting that topical or rectal formulations provide serum levels similar to~     oral medication. In the clinical setting, when oral administration of quetiapine is not~     possible (for example, when a patient is extremely ill physically or mentally or both),~     clinicians and pharmacists have collaborated in such cases and have at times had to~     administer quetiapine compounded in other dosage formulations such as rectal or topical~     formulations. Despite clinical effectiveness of these other formulations, there are no~     available studies that have investigated blood levels of the drug other than the oral form.~     The investigators are therefore designing this pharmacokinetic study to evaluate the the~     systemic absorption of quetiapine in oral, rectal and topical formulations. If the~     investigators are able to demonstrate detectable levels from rectal and topical quetiapine~     formulations compared to the oral form, this knowledge will enhance clinical psychiatric~     practice by providing a more broad route of administration for quetiapine which is a commonly~     used drug for psychiatric symptoms.~   "
109701|NCT02131532|"~     Stroke is a leading cause of adult disability in the community. Fatigue affects about a third~     of stroke survivors. It results in difficulty taking part in everyday activities, and~     increases risk of hospitalization and death after stroke. Despite of its high prevalence and~     distressing consequences, there is no effective treatment.~      Psychological interventions have improved fatigue in patients with other conditions such as~     multiple sclerosis. These interventions primarily target patients' beliefs about overcoming~     fatigue and their physical activities in daily life. Also studies indicated that post-stroke~     fatigue is associated with mood. Based on this knowledge, the investigator has designed a~     brief psychological intervention for post-stroke fatigue.~      The current study is a feasibility study to test the adequacy of intervention manuals and the~     feasibility of trial processes. This study will need 12 stroke survivors who have post-stroke~     fatigue and are over three months but within two years after their stroke. Stroke survivors~     with severe depression or having insufficient capability in cognition or communication will~     not be included. The investigator will check their eligibility by questionnaires and~     interviews and then invite eligible people to take part in the study.~      This intervention will be delivered by a therapist (a clinical psychologist) to each~     participant through six face-to-face therapy sessions. Each session will be about one hour~     and be two weeks' apart. During the sessions, participants will discuss with the therapist~     their fatigue problems, and, with the support from the therapist, work out ways to solve~     their problems. One month after the last face-to-face session, each participant will receive~     a feedback session by telephone from the therapist. Each participant will be followed up to~     three months after the last face-to-face session.~      After all participants complete their feedback sessions, the investigator will invite them to~     a group meeting to share their experiences of taking part in this trial and makes suggestions~     as how their experiences of this intervention, and also of this trial, could be improved.~   "
109702|NCT02131519|"~     Central venous access may be essential in pediatric patients for fluid and a blood product~     administration, medication, parenteral nutrition, renal replacement therapy and hemodynamic~     monitoring. Obtaining central venous access in pediatric patients can be challenging, failure~     rates in pediatric patients range from 5% to 19% with reported complication rates from 2,5%~     to 22% The landmark technique has been standard approach for many years. In comparison with~     landmark method in pediatric patients the use of ultrasound is associated with an increased~     success rate decreased operative time, reduced number of cannulation attempts , and a~     decreased number of carotid artery punctures. We wanted to evaluate our success rate using~     ultrasound as a guidance during central vein insertion.~   "
109703|NCT02131506|"~     A Phase Ib Study of Lapatinib in Combination with Caelyx in Patients with Advanced HER2~     positive pretreated Breast Cancer.~      Treatment Plan:~      Lapatinib is given at escalating doses orally and continuously on days 1-21. Caelyx is~     administered at escalating doses in a 60-minute i.v. infusion on day 1. Each cycle is defined~     as 21 days. Four dose levels are planned. Dose level -1, Caelyx 30 mg/mq & Lapatinib 1000 mg~     die; dose level 1, Caelyx 30 mg/mq & Lapatinib 1250 mg die; dose level 2, Caelyx 30 mg/mq &~     Lapatinib 1500 mg die; dose level 3, Caelyx 40 mg/mq & Lapatinib 1500 mg die. Three patients~     will be initially enrolled in each dose level starting from level 1. If none of the first~     triplet of patients will develop DLT, the dose will be escalated to the next level for the~     subsequent three patients. If one of the first triplets of patients will develop first-course~     DLT, a maximum of 3 additional patients will be entered at the same dose level. The MTD is~     defined as the dose below that at which two patients have experienced DLT. Lapatinib will be~     self-administered by the patient in an outpatient setting at the dose of the assigned step.~     Patients will take the drug daily by mouth on days 1 to 21 of each cycle. Caelyx will be~     administered by intravenous infusion over an exact period of 1 hour (preferably by a pump to~     guarantee a constant speed of infusion) on day~      1 of each cycle repeated every 21 days.~      STATISTICAL METHODOLOGY:~      Evaluation of toxicity: all patients will be evaluable for toxicity from the time of their~     first treatment with Caelyx and Lapatinib.~      Evaluation of response: all patients included in the study must be assessed for response to~     treatment, even if there are major protocol treatment deviations or if they are ineligible.~      All conclusions should be based on all eligible patients. Subanalyses may then be performed~     on the basis of a subset of patients, excluding those for whom major protocol deviations have~     been identified .However, these subanalyses may not serve as the basis for drawing~     conclusions concerning treatment efficacy, and the reasons for excluding patients from the~     analysis should be clearly reported. The 95% confidence intervals should also be provided.~   "
109704|NCT02131493|"~     This study is a randomized, open-label, controlled study that will compare the efficacy of~     S-1 in combination with gemcitabine to gemcitabine alone as adjuvant treatment for patients~     with surgically resected pancreatic adenocarcinoma.~   "
109765|NCT02130687|"~     In this study the investigators will test the hypothesis that dipeptidyl peptidase IV (DPP4)~     inhibition attenuates the antihypertensive effect of angiotensin-converting enzyme (ACE)~     inhibition but not angiotensin receptor blockade or calcium channel blockade. The~     investigators further hypothesize that this effect is mediated by substance P.~   "
109705|NCT02131480|"~     Uterine leiomyosarcomas and soft tissues are rare tumors with a poor prognosis when~     metastatic or locally advanced. They have an average chemosensitivity mainly to doxorubicin,~     ifosfamide, cisplatin, gemcitabine and trabectedin but response rates in combination in first~     line does not exceed 55% for uterine leiomyosarcomas and 35% for leiomyosarcomas of soft~     tissue.~      The trabectedin is a new cancer drug that has obtained marketing authorization after failure~     of anthracyclines and ifosfamide in the treatment of soft tissue sarcomas (STM) in Europe. It~     has especially shown efficacy in myxoid liposarcomas, leiomyosarcomas and synoviosarcoma.~      This study aims to evaluate the usefulness of the combination of trabectedin with doxorubicin~     in first-line treatment of uterine or soft tissue leiomyosarcoma.~   "
109706|NCT02131467|"~     Cervical dystonia (CD) is the most common focal dystonia. Currently there are no effective~     oral medications for the treatment of CD. While botulinum toxin injections improve symptoms,~     they require repeated injections by a trained physician and some patients stop responding to~     injections or never respond at all. Therefore, alternative treatment options for CD are~     needed. One new agent is a drug that targets glutamate receptors that are thought to be~     involved dystonia. This drug, perampanel, was originally developed for epilepsy and is~     licensed for use in the USA and Canada for treating epilepsy. The purpose of this study is to~     test the effectiveness of perampanel in treating the symptoms of CD.~   "
109707|NCT02131454|"~     Pharmacologic treatment of asthma and COPD is based mainly on inhalations. The aim of the~     study is to determine if short training of inhalation technique in patients with obstructive~     diseases may influence the course of asthma and COPD.~   "
109708|NCT02131441|"~     Recent clinical experience showed that laparoscopic hepatectomy has advantages of minimally~     invasive compared to open liver resection, however, laparoscopic liver resection is still~     difficult and risky. Currently it is only carried out in a few large medical centers with~     slow development. The related research studies were retrospective analysis, there were no~     prospective randomized controlled multi-center study reported. Because of its relatively~     simple anatomical advantages, left liver seems to be as the best platform to ensure maximum~     safety and feasibility of prospective randomized study for laparoscopic hepatectomy .This~     project intends to carry out a prospective randomized controlled multi-center study to look~     for evidence of safety, efficacy and minimally invasive of laparoscopic left liver resection,~     evaluate the long-term efficacy including overall survival, disease-free survival as well as~     time to disease recurrence for the left liver carcinoma.~   "
109709|NCT02131428|"~     Heart failure is the most costly diagnosis in the Medicare population. Clinical depression is~     strikingly common in heart failure patients, and not only diminishes their quality of life,~     but also is associated with a markedly increased risk of hospitalization or death. This study~     is designed to further our understanding of the behavioral and biological effects of~     depression in patients with heart failure, so that appropriate treatments can be developed.~   "
109710|NCT02131415|"~     This is a non-interventional, Canadian, study in patients treated with Abilify Maintena™ for~     schizophrenia followed for 24 months, with 9 visits recommended. Study assessments and~     administration of questionnaires will take place during the patient regular assessments or~     injection visits that are part of routine care. The main objective of the study is to~     describe the impact of treatment with Abilify Maintena™ on global functional status.~   "
109711|NCT02131402|"~     The aim of this non-dispensing fitting study is to evaluate the subjective comfort, lens~     handling, lens fitting characteristics and visual acuity of different hydrogel lens designs~     versus silicone hydrogel lenses~   "
109712|NCT02131389|"~     The purpose of this study is to evaluate the use and efficacy of the I-Hip for primary total~     hip replacement surgery.~   "
109713|NCT02131376|"~     Preserving kidney function during removal of a kidney tumor is becoming increasingly~     important as rates of chronic kidney disease increase. A novel modifiable factor (suture~     closure of the defect caused by tumor removal) was discovered on retrospective studies to~     account for nearly two-thirds of the 15% volume loss commonly seen in operated kidneys. We~     hypothesize that a randomized controlled surgical trial will show that omitting the suture~     closure both preserves renal function and will not lead to unreasonable postoperative~     complications.~   "
109714|NCT02131363|"~     This purpose of this study is to evaluate the safety and performance of a treatment kit for~     ingrowing toenail, primarily by determining the number of subjects who show a reduction in~     the severity of their ingrowing toenail.~   "
109715|NCT02131350|"~     The purpose of this study is to evaluate the mean gain in best corrected visual acuity and~     the number of intravitreal ranibizumab (IVR) injections under the combination treatment of~     IVR, focal/grid laser and panretinal photocoagulation. Our hypothesis is that suitable~     photocoagulation decreases the number of IVR injections.~   "
109716|NCT02131337|"~     EFFICAS II proposes to test the hypothesis that treatment efficacy correlates to contact~     force parameters applied for pulmonary vein isolation (PVI) during AF ablation.~   "
109717|NCT02131324|"~     The purpose of this study is to evaluate the potential of DFD06 cream to suppress the HPA~     (hypothalamic-pituitary-adrenal) axis as compared to clobetasol propionate cream, 0.05% cream~     when applied twice daily for 15 days.~   "
109718|NCT02131311|"~     This study will evaluate the effectiveness of the pessary device by assessing reduction in~     urine leakage in approximately 80 women with SUI. Efficacy will be assessed by pad weight~     gain, frequency of stress urinary incontinence events, and a quality of life questionnaire.~   "
109719|NCT02131298|"~     This study is designed to evaluate the potential effect of itraconazole on the~     pharmacokinetics of palbociclib.~   "
109766|NCT02130674|"~     Severe traumatic brain injury is associated with life-threatening and incapacitating~     secondary injury.~      Contemporary therapeutic interventions are aimed at preventing and treating secondary damage.~     In this context, improved cerebral metabolism is an important target in modern neurointensive~     care.~      The main hypothesis is that continuous intravenous infusion of glutamyl-alanyl dipeptide~     restores disturbed brain metabolism following severe traumatic brain injury.~   "
109799|NCT02130245|"~     The best management of the acute cholecystitis is to do laparoscopic cholecystectomy. The~     hypothesis is that to do it as an early intervention after patient admission is better than~     delayed cholecystectomy regarding the hospital stay, interval for antibiotic, the easiness of~     the operative maneuver reflected by operative time, conversion and intraoperative~     complications.~   "
109720|NCT02131285|"~     Background: Balance control relies on accurate perception of visual, somatosensory and~     vestibular cues. Sensory flow is impaired in Multiple Sclerosis (MS) and little is known~     about the ability of the sensory systems to adapt after neurological lesions reducing sensory~     impairment. The aims of the present study were to verify whether:~        1. Balance rehabilitation administered in a challenging sensory conditions would improve~          stability in upright posture~        2. the improvement in a treated sensory condition would transfer to a non treated sensory~          condition.~      Methods: Fifty three persons with Multiple Sclerosis, median (min-max) Expanded Disability~     Status Scale score of 5 (2.5-6.5), participated in a Randomized Controlled Trial and were~     randomly assigned to two groups. The Experimental group received balance rehabilitation aimed~     at improving motor and sensory strategies. The Control group received rehabilitation~     treatment which did not include training of sensory strategies. Persons with Multiple~     Sclerosis were blindly assessed by means of a stabilometric platform with eyes open, eyes~     closed and dome, on both firm surface and foam. Anterior-posterior and medio-lateral sway,~     velocity of sway and the length of Center of Pressure (CoP) trajectory were calculated in the~     six sensory conditions.~   "
109721|NCT02131272|"~     This trial is conducted globally. The aim of the trial is to investigate the efficacy and~     safety of insulin detemir versus insulin Neutral Protamine Hagedorn (NPH) in combination with~     the maximum tolerated dose of metformin and diet/exercise on glycaemic control in children~     and adolescents with type 2 diabetes insufficiently controlled on the maximum tolerated dose~     of metformin with or without other oral antidiabetic drug(s) with or without basal insulin.~   "
109722|NCT02131259|"~     In Japan, post-approval execution of post marketing surveillance (PMS) is requested by the~     Japanese Pharmaceutical Affairs Law (J-PAL) in order to accumulate safety and efficacy data~     for reexamination. Reexamination period is defined by J-PAL. Eight years after approval of a~     new substance, results of PMS need to be submitted as a part of reexamination dossier to the~     Japanese regulatory authority, the Ministry of Health, Labour and Welfare (MHLW).~   "
109723|NCT02131246|"~     This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetic~     (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the~     investigated drug on the body) properties of faster-acting insulin aspart in subjects with~     Type 1 diabetes.~   "
109724|NCT02131233|"~     To evaluate the safety and efficacy of reformulated raltegravir (MK-0518) 1200 mg once daily~     in combination with TRUVADA™ versus raltegravir 400 mg twice daily in combination with~     TRUVADA™ in HIV-1 infected, treatment-naive participants. The primary hypothesis being tested~     is that reformulated raltegravir 1200 mg once-daily is non-inferior to raltegravir 400 mg~     twice-daily, each in combination therapy with TRUVADA™, as assessed by the proportion of~     participants achieving HIV-1 ribonucleic acid (RNA) <40 copies/mL at Week 48.~   "
109725|NCT02131220|"~     The purpose of this study is to determine whether intracoronary selective thrombolysis are~     more effective than tirofiban on the coronary flow during primary percutaneous coronary~     intervention for the acute myocardial infarction.~   "
109726|NCT02131207|"~     This pilot clinical trial studies how well magnetic resonance imaging (MRI) before biopsy~     works in diagnosing patients with prostate cancer. MRI is a procedure in which radio waves~     and a powerful magnet linked to a computer are used to create detailed pictures of areas~     inside the body. This diagnostic procedure may aid in identifying lesions in the prostate~     which may have cancer. The lesions can then be targeted during the prostate biopsy to improve~     the accuracy of identifying prostate cancer.~   "
109727|NCT02131194|"~     To determine the efficacy of Lenstatin™, an over-the-counter nutritional supplement, in~     inhibiting the progression of nuclear cataract in eyes after pars plana vitrectomy.~   "
109728|NCT02131181|"~     The purpose of this study is to determine the incidence, long term outcome and factor related~     to postoperative delirium in elderly patients after non-cardiac surgery.~   "
109729|NCT02131168|"~     Crohn's disease and ulcerative colitis are inflammatory disorders of the gut which cause~     major life-long disability. They affect males and females, with the commonest age of onset in~     childhood, teens and early adult life. Previously restricted almost exclusively to the West,~     these conditions are becoming much more common in Asian countries, including Hong Kong - the~     cause of this dramatic change is unknown.~      The cause of IBD is widely accepted as relating to the mucosal immune response to stimulation~     from the gut bacteria, on a background of genetic susceptibility. The bacteria and other~     organisms in the gut play a central role in the development of IBD in the West. However it is~     unknown if the gut bacteria differ between Chinese patients with IBD and non-IBD (healthy~     subjects) in Hong Kong, and whether it is affected by diet or changes in diet. A family~     history is the largest risk factor for the disease. More than 50 different genes associated~     with IBD have recently been identified in the West and preliminary data showed that Chinese~     patients have a different genetic profile to Western populations.~      This project aims to explore the true incidence of IBD in Hong Kong and factors that may be~     contributing to, or causing, the increase of IBD in Hong Kong. Investigators aim to~     investigate the number of new cases of IBD within a five year period and factors that may~     account for the cases. Investigators will also study the choice of medical therapy, quality~     of life and quality of health care in patients with IBD.~   "
109730|NCT02131155|"~     This randomised, double-blind phase III trial will be performed in patients with head and~     neck squamous cell carcinoma (HNSCC). The objectives of the trial are to compare the efficacy~     and safety of afatinib (BIBW 2992) with placebo as adjuvant therapy to patients who have~     received definitive chemo-radiotherapy.~   "
109731|NCT02131142|"~     The purpose of this study is to collect additional safety and effectiveness data for on the~     Biosensors BioFreedom™ BA9 Drug Coated Coronary Stent in patients with native, de novo~     coronary artery disease.~   "
109732|NCT02131129|"~     This study proposes to examine the application of rTMS for the treatment of cognitive~     dysfunction in FEP. This is an important population for study because if effective, rTMS may~     represent a preventative treatment for the development of social and vocational impairment~     that is associated with cognitive dysfunction in schizophrenia. This study will also seek to~     refine the understanding of the brain circuitry that mediates the potential pro-cognitive~     effects of rTMS through the use of functional magnetic resonance imaging (fMRI) at baseline~     and following the course of rTMS administration.~   "
109733|NCT02131116|"~     Insight, or lack of illness awareness, is a prominent and pressing clinical concern in the~     treatment and recovery of patients with psychotic disorders. Impaired insight results in poor~     treatment engagement and adherence, more frequent hospitalizations, greater positive and~     negative symptoms, and poor psychosocial functioning. Addressing these complications early in~     the disease process may lead to altered illness course with better outcomes. To date, only a~     small number of nonpharmacological interventions have been developed, none of which~     adequately address poor insight during the first few years of psychotic illness. Further,~     presently available therapeutic interventions do not attend to difficulties associated with~     improved insight, such as depression. The purpose of this investigation is to implement a~     novel intervention designed to improve insight, metacognition, neurocognition, symptoms, and~     ultimately overall functioning in persons with early psychosis. The novel intervention will~     integrate a number of previously established therapeutic approaches, such as metacognitive,~     narrative, cognitive behavioral and motivational interviewing, and hence be labeled~     Integrated Metacognitive Therapy (IMT). In order to measure the efficacy of IMT, all subjects~     will undergo a battery of assessments in each of these domains prior to and following either~     a novel intervention (N = 10) or treatment as usual (N = 10) for a period of approximately~     six months. Throughout the study, each IMT session (N = 10, 24 sessions each) will be audio~     recorded, transcribed, and de-identified to allow for careful ongoing qualitative analyses of~     potential active and inert ingredients of the approach and ultimately the development of an~     IMT manual which can then be tested in a larger, more rigorous randomized control trial. This~     investigation will play an important role in advancing current knowledge about treating~     insight in early psychosis. Further, it will serve to expand upon the intervention tools~     available by producing a much needed treatment manual designed specifically to target insight~     during an illness phase crucial for positive long term outcomes in psychosis.~   "
109734|NCT02131103|"~     1. Objective: To evaluate short- and long-term in the STEMI patients who successfully~          thrombolysis with early routine and delay percutaneous coronary intervention in~          low-intermediate risk patients.~        2. Educational/ application advantages: To evaluate the time of early and delay PCI after~          received fibrinolysis had an effect to the short- and long-term clinical outcomes in~          low- intermediate GRACE risk score patients. No available of randomized controlled study~          in these group of the patients.~   "
109735|NCT02131090|"~     A number of methods are currently used to prevent movement of epidural catheters in women~     during labour. These usually consist of sticky dressings applied to the patient's back. The~     purpose of this study is to compare how much epidural catheters move when secured with three~     commonly used different fixation dressings with the aim of identifying the best method of~     securing epidural catheters.~      Movement of epidural catheters has several clinical implications. Usually only a short length~     of epidural catheter is left in the epidural space, and therefore any significant movement~     could result in the catheter moving out of the epidural space leading to a loss of the pain~     relieving effects of the epidural.~      Once epidural failure has occurred due to catheter migration, a second catheter must be~     inserted in order to re-establish pain relief and thus the patient is exposed to the risks of~     epidural insertion for a second time.~      If the researchers in this study can identify a method of fixing epidural catheters which~     results in the least amount of catheter movement, then patients could benefit from more~     reliable epidural pain relief, fewer repeated procedures and the risks associated with~     repeated procedures.~      The principle objective of the study is to determine which epidural fixation dressing results~     in the least amount of epidural catheter movement from the time of epidural insertion (during~     labour) to the time of epidural removal (after labour).~   "
109736|NCT02131077|"~     The objective of this study is to evaluate the safety and efficacy of allogeneic~     adipose-derived stem cells (ALLO-ASC) in patients with lateral epicondylitis.~   "
109737|NCT02131064|"~     This is a randomized, multicenter, open-label, two-arm study in treatment-naive participants~     with operable, locally advanced, or inflammatory, centrally-assessed HER2-positive early~     breast cancer (EBC) whose primary tumors were greater than or equal to (>/=) 2 centimeters~     (cm). The study was designed to evaluate the efficacy and safety of trastuzumab emtansine +~     pertuzumab (experimental arm; T-DM1 + P) versus chemotherapy, trastuzumab + pertuzumab~     (control arm; TCH + P). The study comprised a neoadjuvant treatment period, followed by~     surgery, and an adjuvant treatment period.~      Treatment can be stopped due to disease recurrence, unacceptable toxicity, withdrawal of~     consent, or study termination.~   "
109738|NCT02131051|"~     This is a comparative, open label, parallel group, non interventional study to further~     demonstrate the effectiveness and tolerability of Ectoin Allergy Nasal Spray and Eye drops.~     In addition the effectiveness and safety shall be compared to Azelastine containing nasal~     Sprays and Eye drops. The patient applied Ectoin® Rhinitis Nasal Spray / Eye drops or takes~     Azelastine nasals spray and eye drops according to the instructions for use. The observation~     takes place over a period of 7 days. Response to treatment is recorded at day 7 by the~     physician and in daily by the patient in a dairy.~   "
109739|NCT02131038|"~     This is a comparative, open label, parallel group, non interventional study to further~     demonstrate the effectiveness and tolerability of Ectoin Allergy Nasal Spray. In addition the~     effectiveness and safety shall be compared to a Cromoglycid acid containing nasal spray. The~     patient applies Ectoin Allergy Nasal Spray or Cromoglycid acid containing nasal spray~     according to the instructions for use. The observation takes place over a period of 14 days.~     Response to treatment is recorded at day 7 and day 14 by the physician and by the patient in~     a dairy at defined time intervalls.~   "
109740|NCT02131012|"~     Intraocular delivery of celecoxib will be an effective means to treat inflammation and~     macular edema and prevent structural complications and vision loss in patients with chronic~     inflammation or macular edema who are unable to tolerate corticosteroids due to their side~     effects.~   "
109767|NCT02130661|"~     Rilapladib is a potent and selective inhibitor of lipoprotein associated phospholipase A2~     (Lp-PLA2), which was previously under development for the treatment of atherosclerosis and is~     currently being developed for the treatment of Alzheimer's disease.~      This study is a single-center, open-label, two-part study. The two study parts will run~     independently. Subjects dosed in one part of this study will not be permitted to participate~     in the other part.~      Part A will investigate the pharmacokinetic profile of rilapladib and its metabolites,~     SB-664601 and GSK1174379, after single dose and steady state dosing of rilapladib 250~     milligram (mg) along with the biliary and urinary elimination pathways of rilapladib 250 mg.~     Part B will determine the effect of repeat administration of itraconazole on the PK of a~     single oral dose of rilapladib 25 mg.~      Healthy male and female subjects, aged 18-65 years, will be recruited for this study. Ten~     subjects will be recruited for Part A and 20 subjects will be recruited for Part B.~   "
109768|NCT02130648|"~     The purprose of this study is to develop and validate an analytical and clinical NIPD test~     for cystic fibrosis from maternal blood by analysis circulating free fetal DNA (cff-DNA),~     searching for the paternal mutation in families with CFTR compound heterozygosity~   "
109741|NCT02130999|"~     Hetlioz™ (tasimelteon) is used in the treatment of Non-24-Hour-Sleep-Wake Disorder (Non-24).~     Non-24 is very common in people who are totally blind because light can not reset their body~     clock. This causes the internal sleep-wake cycle to be out of sync with the 24-hour~     day-night. Non-24 is a serious, chronic circadian rhythm disorder in the blind that causes~     nighttime sleep problems and a wide range of daytime difficulties, including an overwhelming~     urge to nap.~      Tasimelteon will be given in two ways; orally (by mouth) as a 20 mg capsule and intravenously~     (I.V.) by infusion through a catheter (not an injection) into a vein. The oral administration~     is approved by the FDA. The I.V. administration is considered investigational as it has not~     been approved by the FDA. This will be the first time tasimelteon will be given to humans by~     intravenous (I.V.) injection.~      The purposes of this research study are to:~        -  assess how quickly a single 20 mg oral dose of tasimelteon is absorbed into the body;~        -  evaluate the single-dose pharmacokinetics of tasimelteon after a single 20 mg oral dose~          and after a single 2 mg I.V. dose;~        -  evaluate the single-dose pharmacokinetics of tasimelteon metabolites after a single 20~          mg oral dose and after a single 2 mg I.V. dose;~        -  evaluate the safety and tolerability of a single 20 mg oral dose of tasimelteon; and~        -  evaluate the safety and tolerability of a single 2 mg I.V. dose of tasimelteon.~      Pharmacokinetics (PK) is the study of how a drug is absorbed, distributed, metabolized, and~     eventually eliminated by the body. Pharmacokinetics is what the body does to the drug. Blood~     samples will be taken throughout the study for PK analysis.~   "
109742|NCT02130986|"~     The ProACT study is a 5 year, multicenter study that will test the effect of implementation~     of a novel procalcitonin guideline on antibiotic use and adverse outcomes in emergency~     department (ED) patients with lower respiratory tract infection (LRTI).~   "
109743|NCT02130973|"~     This is a three-year study to evaluate the effect of sequential therapy of Forteo~     (teriparatide) and denosumab on bone density at the spine, hip, leg and forearm.~   "
109744|NCT02130960|"~     This research is being conducted to study the reliability of a method used to measure resting~     metabolic rate, or how much energy a person expends while at rest.~   "
109745|NCT02130947|"~     This randomized pilot study will be conducted in men with metastatic castration resistant~     prostate cancer (mCRPC) within 3 months of initiating abiraterone or enzalutamide. The~     purpose of this pilot study is to evaluate the effects of a 12 week exercise intervention in~     mCRPC patients who have recently started on additional androgen suppression therapy.~   "
109746|NCT02130934|"~     This is a non-randomized prospective pilot study in a single academic center with historic~     controls. This study will compare Cardiac Magnetic Resonance Images (MRI) of patients who~     have undergone childhood cancer treatment that has cardio-toxic effects to historic controls.~     The ultimate goal of this study is to develop a safe and effective method for early diagnosis~     of heart problems in children who are receiving chemotherapy treatments that may be toxic to~     the heart.~   "
109747|NCT02130921|"~     This proposed study is an initiative for HIV prevention and care that integrates intervention~     efforts at multiple strata: Community Health Workers (CHWs), Injecting Drug Users (IDUs), and~     their Family Members (FMs). The proposed study will demonstrate the process of development,~     implementation, and evaluation of an intervention for CHWs, IDUs, and their FMs. One aim is~     to increase the CHWs' capacities to effectively interact with IDUs and FMs for HIV and drug~     use prevention and treatment. Using a combination of participatory action research and a~     randomized controlled trial design, this study has the potential to maximize PEPFAR impact in~     Vietnam and other PEPFAR-funded countries by identifying a sustainable mix of interventions~     and their implementation in different settings. The findings may benefit not only Vietnam but~     also a global audience by investigating enhanced methods for controlling the HIV epidemic.~   "
109748|NCT02130908|"~     This study is a pilot study to investigate whether intake of lean or fatty fish, or lean meat~     would affect parameters related to health in healthy non-obese adults, and will serve as~     basis for future calculation of group sizes in coming studies. Participants consumed~     750g/week of fillets of fish or meat for 4 weeks.~      Hypothesis:~      High intake of either lean or fatty fish will not affect serum concentrations of lipids and~     inflammatory markers as well as improve glucose tolerance during the 4 week intervention~     period when compared to lean meat intake.~   "
109749|NCT02130895|"~     This mixed methods study seeks to assess and understand the impact of using an advanced CDS~     tool to present the STOPP criteria to support prescribers at the point of decision-making. We~     ask the overarching question:~      **How can clinical decision support tools effectively translate a complex set of~     evidence-based rules into primary care clinical practice?**~      The work is divided into 2 phases.~      PHASE 1: Randomized control trial. We will measure change in potentially inappropriate~     prescribing by primary care prescribers (e.g. family doctors) who are using the Clinical~     Decision Support (CDS) tool in their Electronic Medical Record (EMR), as compared to those~     who are not. Potentially Inappropriate Prescribing is defined by the STOPP criteria, the same~     criteria that will be used in the clinical decision support tool in the EMR. We will use the~     OSCAR EMR for this study. EMR based queries will be developed to assess the number of~     potentially inappropriate prescriptions are current in each of 12 physician practices at~     baseline and at 16 weeks.~      PHASE 2: We will then complete a qualitative follow up with participants to aid in~     understanding how primary care prescribers perceived the CDS. This will help explain Phase 1~     findings and provide additional information to enhance future decision support tools.~   "
109769|NCT02130635|"~     This is a randomised, double-blind, placebo controlled, parallel group study to evaluate the~     safety, tolerability, pharmacokinetics and dose response of multiple doses of GSK2269557~     administered as a dry powder in COPD subjects. Pharmacodynamic effects on biomarkers will~     also be assessed. This study will have two parts. In Part A, subjects will be randomized to~     active or placebo treatment in a 3:1 ratio and in Part B, to placebo or one of the six doses~     of active treatment in an equal ratio. A sufficient number of COPD subjects (male and female~     of non-child bearing potential) will be screened to ensure that approximately 30 subjects are~     enrolled and at least 20 evaluable subjects are obtained for Part A and approximately 35~     subjects will be enrolled for Part B. In both the parts, subjects will receive study~     treatment once daily for 14 consecutive days. Placebo control will be included for a valid~     evaluation of adverse events attributable to treatment versus those independent of treatment.~   "
109750|NCT02130882|"~     Background:~      - Eosinophils are white blood cells that help fight infections. High eosinophil levels can~     damage people s organs, causing hypereosinophilic syndrome (HES). Researchers want to study~     if the drug benralizumab can help people with HES.~      Objective:~      - To test if benralizumab can safely decrease eosinophils in people with HES.~      Eligibility:~      - Adults age 18-65 who have been on stable HES therapy for at least 1 month but still have~     symptoms and high eosinophil levels.~      Design:~        -  Participants will be screened with medical history, physical exam, and urine and blood~          tests. They will take simple heart and lung tests.~        -  Participants will also have a bone marrow biopsy. A numbing medicine is injected into~          the outer covering of the bone. Then a needle is inserted into the bone. A fast suction~          movement takes bone marrow cells.~        -  Phase 1: Participants will randomly receive either the study drug or placebo as an~          injection.~        -  They will have daily visits for the next 3 days, then 4 weekly visits, and then 4~          biweekly visits. Each time, they will have medical history, physical exam, blood tests,~          and a check of side effects.~        -  They will receive another dose of the study drug or placebo at 1 month and 2 months~          after the first injection.~        -  Phase 2 repeats the Phase 1 schedule. All participants will receive the study drug.~        -  At 1 visit, participants will also receive a vaccine. At 4 visits, they will repeat the~          heart and lung tests. They will also have one other bone marrow biopsy.~        -  After week 24, participants will receive the study drug either 6 times over 6 months or~          twice over 6 months.~   "
109751|NCT02130869|"~     This is a pilot clinical trial investigating the addition of haploidentical natural killer~     cell infusion to autologous stem cell transplantation. This intervention will be evaluated in~     children with high-risk solid tumors for whom autologous transplantation is indicated.~     Natural killer cells from a haploidentical family member will be given after high dose~     chemotherapy and positively selected autologous stem cells. In patients with neuroblastoma,~     the anti-GD2 antibody hu14.18K322A will also be given. The effect on normal hematopoietic~     cell recovery will be evaluated and survival of children treated with this approach will be~     determined.~      The investigators expect to enroll 36 participants. Haploidentical family members (donors)~     will also be recruited to provide natural killer cells.~   "
109752|NCT02130856|"~     There are over 3 million annual neonatal deaths. Approximately 2/3 of neonatal deaths are due~     to infection, low birth weight (LBW), and prematurity. Low tech but high impact interventions~     and commodities used in unconventional ways could save hundreds of thousands of newborn~     lives. We propose an integrated evidence-based toolkit usable by community health workers~     (CHW) to reduce neonatal deaths. The kit will include: Chlorhexidine to be applied to the~     umbilical stump, sunflower oil emollient to be applied to the skin, ThermoSpot to identify~     hypo/hyperthermia, and a Mylar infant sleeve with non-electric warmer.~   "
109753|NCT02130843|"~     A report of a technique for insertion a soft urodynamic catheter into the bladder, when~     urethral obstruction causes the catheter to bend and fold over itself at the resistance site.~   "
109754|NCT02130830|"~     Rubber band ligation is a simple and effective procedure for the management of hemorrhoidal~     disease. However, 90% of patients have some degree of discomfort associated with the~     procedure and up to 40% develop clinically significant pain. Some studies have used local~     anesthesia to reduce pain with promising results, but the use of topical anesthesia has not~     been reported before.~      The investigators hypothesize that the use of topical anesthesia before rubber band ligation~     significantly reduces post procedure pain.~   "
109755|NCT02130817|"~     The purpose of this study is to evaluate the safety and effectiveness of an immunosuppressive~     medication, Belatacept, as a replacement for a calcineurin inhibitor, in combination with a~     standard of care regimen of immunosuppressive medications and plasma exchange (plasmapheresis~     and immunoglobulin treatment) for kidney transplant patients who are moderately sensitized~     against their deceased donor and at-risk for delayed graft function. The hypothesis is that~     moderately sensitized patients who receive Belatacept treatment with the standard of care~     regimen will lead to lower acute rejection rates than historical controls based on assessment~     of standard of care biopsies and standard Banff criteria.~   "
109756|NCT02130804|"~     Background: The prevalence of obesity has increased throughout the last three decades due to~     genetic, metabolic, behavioral, and environmental factors. Obesity and high-fat western diets~     activate inflammatory processes, which promote development of insulin resistance as well as~     other metabolic complications. Increasing obesity rates are a major public health concern in~     the Hispanic population due to the large number of Hispanics suffering from obesity. Based on~     preliminary data, we propose a double-blind randomized clinical trial of Salsalate therapy in~     obese Hispanic young adults. Salsalate treatment shows promise for decreasing inflammation~     under conditions of weight stability by reducing macrophage infiltration of adipocytes.~     Hispanics have the greatest amount of visceral adipose tissue (VAT), liver fat, and~     inflammation when compared to other ethnic groups, thereby increasing the potential for~     treatment effects in this high-risk population.~      Purpose: The purpose of this study is to demonstrate through a proof-of-concept trial that~     Salsalate induced reductions in adipose tissue inflammation are possible under conditions of~     weight stability.~      Methodology: We will recruit obese Hispanic young adults (18 - 35 years) from hospitals,~     clinics, and community centers. Study Endpoints: Primary outcomes will be macrophage~     infiltration as assessed by the presence of crown-like structures (CLS) in subcutaneous~     adipose tissue (SAT) biopsies, liver fat, insulin sensitivity, and fasting glucose. We will~     also assess plasma levels of monocyte chemoattractant protein (MCP)-1, tumor necrosis factor~     (TNF)-α, interleukin (IL)-1, C-reactive protein (CRP), and SAT gene expression of nuclear~     factor kB (NF-kB) and insulin signaling pathways.~      Intervention and Follow-up: Participants will be randomly assigned to four weeks of treatment~     with Salsalate (4 g/d) or placebo and will be studied under weight maintenance conditions.~     These measures will enable us to determine if Salsalate treatment is capable of reducing~     adipose tissue inflammation and related metabolic outcomes in the absence of weight loss.~   "
109770|NCT02130622|"~     Adult diabetic patients (ages 18-65) with gastric emptying scintigraphy-confirmed delayed~     gastric emptying will be recruited to participate in the study. Using double-blinded~     methodology, study participants will be randomly assigned to one of two treatment arms:~     promethazine 12.5 mg three times daily for 28 days or placebo three times daily for 28 days.~     The primary outcome will be the change in gastroparesis symptom severity, as measured by the~     Gastroparesis Cardinal Symptom Index (GCSI) at four weeks compared to baseline. Participants~     will be seen for a clinic evaluation at weeks 0, 2 and 4, during which symptom scores,~     adverse events and treatment compliance will be assessed. It is hypothesized promethazine~     treatment will be superior to placebo in improving symptoms of gastroparesis.~   "
109771|NCT02130609|"~     The objective of this study is to improve the treatment guidelines for the Elite+ by~     determining the maximum safe settings for skin and correlate them to measurement of Melanin~     Index (MI) (MI).~   "
109757|NCT02130791|"~     Insufficient sleep is common, affecting 20-40% of adults, and resulting from sleep disorders,~     medical conditions, work demands, stress/emotional distress, and social/domestic~     responsibilities. It produces significant social, financial and health-related costs, and it~     has increasingly become a major public health concern as population studies worldwide have~     found that reduced sleep duration is associated with increased risks of obesity, morbidity,~     and mortality. It is well established that sleep loss causes fatigue and sleepiness, as well~     as errors and accidents that are due to its adverse neurobehavioral effects on alertness,~     mood, and cognitive functions. However, there are substantial, trait-like differences among~     people in the extent to which they experience such neurobehavioral deficits when sleep~     deprived. Common genetic variations involved in sleep-wake, circadian, and cognitive~     regulation may underlie these large inter-individual differences in neurobehavioral~     vulnerability to sleep deprivation, though it remains unclear whether different types of~     sleep deprivation involve the same phenotypic responses and same genotypic contributors. This~     project will be the first large-scale investigation of markers of differential cognitive~     vulnerability to both acute total sleep loss and chronic partial sleep loss. It will identify~     individuals who are at significant risk for fatigue and severe impairments from sleep loss. A~     total of 110 healthy adults will undergo a 13-day laboratory protocol to thoroughly~     characterize their cognitive, psychological and physiological responses to two of the most~     common forms of sleep loss--acute total sleep deprivation (1 night of sleep loss) and chronic~     partial sleep deprivation (5 nights of sleep limited to 4 hr). The findings from this study~     will represent a critical first step toward tailoring appropriate follow-up interventions for~     sleep loss and its symptomatic relief by finding predictors of at-risk individuals who should~     avoid sleep loss whenever possible, and/or seek effective countermeasures. Whether or not~     markers of neurobehavioral vulnerability to sleep loss are identified, the results of the~     project will help inform public policies pertaining to the need for adequate sleep and for~     countermeasures for sleep loss, and also will further our understanding and management of~     vulnerability to excessive sleepiness due to common sleep and medical disorders.~   "
109758|NCT02130778|"~     Adipose and diabetic patients have glomerular hyperfiltration and enhanced reabsorption of~     sodium in the kidney leading to fluid retention and hypertension. It is already known that~     obese mice (db/db) have salt retention and elevated intrarenal angiotensin II , and that the~     mechanism of the salt retention is similar to the one described in human beings. In~     experimental study from 2009 done by Hirata K and al., published in Biochemical and~     Biophysical Research Communications to both obese type 2 diabetic db/db mice and non-diabetic~     db/m mice hypertension was artificially induced (acute sodium-loading and angiotensin~     II-infusion). Two groups of mice were treated with exendin-4 or vehicle for 12 weeks. Obese~     type 2 diabetic db/db mice show high salt-sensitivity. Exendin-4 demonstrated~     anti-hypertensive effect in db/db mice and angiotensin II-infused mice, related to~     attenuation of high salt-sensitivity. That observation confirmed that exendin-4, a GLP-1~     (Glucagon-like peptide-1) analogue, has extra-islet effect including the regulation of salt~     handling. More then ten years before mentioned observations the presence of GLP 1 receptors~     was confirmed all over the body, also in kidneys. In 2004 Gutzwiller published a study in~     Journal of Clinical Endocrinology and Metabolism that examined 15 healthy subjects and 16~     obese men (mean body mass index, 36 kg/m2) in a double-blind, placebo-controlled, crossover~     study. After overnight fasting hypertonic saline was infuse followed by 3-h infusion of~     GLP-1. Intravenous infusions of GLP-1 enhanced sodium excretion, reduced H+ secretion, and~     reduced glomerular hyperfiltration in obese men. These findings suggest an action at the~     proximal renal tubule and a potential renoprotective effect. Two years later same author with~     colleagues published a new study in Digestion. In a part of new study he observed 8~     volunteers. The protocol included intravenous salt load compared to the effect of an infusion~     of GLP-to isotonic saline (placebo). Extracellular volume expansion induced by an intravenous~     infusion of hypertonic saline was partially compensated by an increase in urinary sodium and~     water excretion with GLP-1. He explained that volume expansion was associated with increased~     renal perfusion, rise in glomerular filtration and the filtered sodium load. It was observed~     that GLP-1 is able to increase renal sodium excretion by 69% and urine volume by 86%.~     Considering all mentioned above it is obvious that GLP-1 have natriuretic effect, although~     its exact mechanism and clinical usefulness remain unclear. Both GLP1 analogues and~     inhibitors of DPP4 (dipeptidyl peptidase 4), elevate GLP1 level, and it would not be a~     surprise to observe similar natriuretic effects in the body. Since GLP 1 is a peptide given~     IV. or sc. there are on long-term studies that observe final possible effect no blood~     pressure, but GLP1 analogues and DPP4 inhibitors enhancing the incretin action demonstrate~     some antihypertensive properties. 2008 in a study done by Mistry GC and al., published in~     Journal of Clinical Pharmacology antihypertensive effect of sitagliptin was observed. In~     nineteen patients on stable treatment with antihypertensive agent(s) investigators found~     small but statistically significant reductions of 24-hour ambulatory blood pressure. There~     are no many definitive clues why the blood pressure should droop during any treatment that~     elevates serum GLP1. At the end of 2009 an analysis was published in American Journal of~     Hypertension, showing results from six trials including 2,171 subjects treated with exenatide~     for at least 6. Again, a significantly greater reduction in systolic blood pressure was~     confirmed, not giving an explanation why it happened so. Finally, Prof. Sjöholm from~     Karolinska institute Sweden published in Diabetes, obesity and metabolism a review concerning~     impact of GLP-1 on endothelial function. He mentioned again decreased blood pressure through~     improvements in diuresis and natriuresis, but he also added a new element, improved~     endothelial dysfunction through GLP-1 receptor-dependent pathway. Though there are many~     speculations, exact antihypertensive effects and water homeostasis of both GLP-1 itself, also~     of GLP1 analogues and DPP4 inhibitors is still unknown. Finally, recent review (Tanaka et~     all) from 2011 confirms mentioned speculations regarding natriuretic effect of GLP1, quote …~     Incretin mimetics and DPP-IV inhibitors are a novel class of antihypertensive drugs with~     natriuretic properties. They can be used in the treatment of salt-sensitive hypertension,~     which is characterized by edema. The idea is to investigate the effect of GLP1 on~     diuresis/natriuresis compared with placebo in healthy non-obese people and to compare~     natriuresis with GLP-1, BNP (brain natriuretic peptide) and ADH (antidiuretic hormone) levels~     in serum.~   "
109759|NCT02130765|"~     To demonstrate that scar-based ventricular tachycardia (VT) ablation using the FlexAbility™~     ablation catheter system results in a superior clinical outcome compared to routine drug~     therapy in subjects with documented Monomorphic Ventricular Tachycardia [MMVT] (both ischemic~     and non-ischemic) while maintaining an acceptable safety profile.~   "
109760|NCT02130752|"~     Gastric cancer as one of the most common gastrointestinal cancers, radical resection of~     primary lesions combined with dissection of regional lymph-nodes is acknowledged by surgeons~     all over the world. By the invented and adopted energy surgical instruments, surgical~     procedure is safer and easier than before. The newly surgical instruments reduce the~     post-operative mortality and morbidity combined easy procedures of surgery. As the most~     popular instruments used in the gastric surgery, ultrasonic scalpel and monopolar~     electrocautery were received lots of attention and concern. Some studies have shown some~     advantage of the two instruments, which were they can facilitate the surgical treatment and~     make the surgery safer and more effective. Although, some small retrospective sample reports~     claimed that ultrasonic scalpel brought benefit in blood loss, dissection lymph-node~     intraoperative complications and even postoperative complications. And Korea small sample~     randomized controlled trail presentation that ultrasonic scalpel can reduced blood loss and~     surgical duration. However, postoperative complications were with no statistical significance~     between the two instruments. Cost- effective analysis of the energy instruments is still~     controversial. Large sample randomized control trail with high quality is needed.~      By the reasons above, a multicenter randomized controlled trial conducted by 9 hospitals from~     North to South in China aims to compare the clinical characteristics and outcomes, when using~     of the ultrasonic scalpel or monopolar electrocautery in traditional open gastrectomy. The~     aim of this study is to evaluate the outcomes of ultrasonic scalpel compared with monopolar~     electrocautery in D2 distal gastrectomy, include, intraoperative parameters, postoperative~     complications, cost data, and post-operative quality of life.~   "
109761|NCT02130739|"~     This study prospectively evaluates the incidence of Horner's syndrome after thoracic epidural~     anesthesia following continuous thoracic epidural analgesia for mastectomy. The incidence was~     1.36% and the mechanism of Horner's syndrome was cephalic spread of the local anesthetic.~   "
109762|NCT02130726|"~     Laparoscopic surgery has been shown to provide important advantages in comparison with open~     procedures in the treatment of several malignant diseases, such as less peri-operative blood~     loss, faster patient recovery and shorter hospital stay. All while maintaining similar~     results with regard to tumour resection margin and oncological survival. In gastric cancer~     the role of laparoscopic surgery remains unclear.~      Current recommended treatment for gastric cancer consists of radical resection of the~     stomach, combined with lymfadenectomy. The extent of lymfadenectomy is considered a marker~     for radicality of surgery and quality of care. Therefore, It is imperative that a new~     surgical technique should be non-inferior with regard to radicality and lymph node yield.~      Preliminary studies show promising results for laparoscopic gastrectomy, but the number of~     studies is small and due to lower incidence of gastric cancer in the West they are often~     underpowered. A prospective randomised clinical trial is indicated in order to establish the~     optimal surgical technique in gastric cancer: open versus minimally invasive gastrectomy.~      Results of the STOMACH trial will further aid in determining the optimal surgical technique~     in patients with gastric cancer.~   "
109763|NCT02130713|"~     Background - bacterial prostatitis (BP) is a common condition accounting responsible for~     about 5-10% of all prostatitis cases; chronic bacterial prostatitis (CBP) classified as type~     II, are less common but is a condition that significantly hampers the quality of life, (QoL)~     because not only is it a physical condition but also a psychological distress. Commonly~     patients are treated with antibiotics alone, and in particular fluoroquinolones are suggested~     by the European Urology guidelines. This approach, although recommended, may not be enough.~     Thus, a multimodal approach to the prolonged antibiotic therapy may be helpful.~      Methods - 210 patients affected by chronic bacterial prostatitis were enrolled in the study.~     All patients were positive to Meares-Stamey test and symptoms duration was > 3 months. The~     purpose of the study was to evaluate the efficacy of a long lasting therapy with a~     fluoroquinolone in association with a nutraceutical supplement (prulifloxacin 600 mg for 21~     days and an association of Serenoa repens 320 mg, Lactobacillus Sporogens 200 mg, Arbutin 100~     mg for 30 days). Patients were randomized in two groups (A and B) receiving respectively~     antibiotic alone and an association of antibiotic plus supplement.~   "
109764|NCT02130700|"~     The goal of this clinical study is to determine the safety and efficacy of VT-464, a~     lyase-selective inhibitor of CYP17, in patients with castration-resistant prostate cancer~     (CRPC) who have been previously treated with Enzalutamide, Androgen Receptor Positive~     Triple-Negative Breast Cancer Patients, and Men with ER positive Breast Cancer.~   "
109853|NCT02129543|"~     The investigators are collecting blood samples to learn more about how the body's immune~     system recovers after stem cell transplant (SCT). Participants are either previous recipients~     of a stem cell transplant, or a donor of stem cells for transplant.~   "
109772|NCT02130596|"~     Obesity occurs at 2-3 times the general population rate in persons living with a psychotic~     illness. The risk of obesity-related serious medical conditions like diabetes and heart~     disease are also two to three times higher in this population. Traditional behavioral weight~     management approaches help more than half of these individuals to lose weight, but a~     significant proportion are not helped. This pilot study is intended to determine the~     feasibility, efficacy, acceptability, and potential clinical utility of an intervention that~     integrates mindfulness, acceptance, distress tolerance, and motivation and commitment~     combined with traditional behavioral strategies for weight loss. This is the first study to~     investigate such an acceptance-based behavioral intervention for weight loss in psychotic~     illness. The results from this study will help to determine whether future research in this~     area is warranted with a larger sample, over a longer period of time.~      Primary hypothesis: Weight loss will be greater in individuals who receive the acceptance~     based behavioral intervention, relative to those who receive nutritional counseling.~   "
109773|NCT02130583|"~     The prevalence of suicidal behaviors in adolescents remains unacceptably high and is a~     significant public health concern. The investigators propose a new treatment approach in~     which skills to increase positive emotions are taught to the most vulnerable at-risk~     adolescents, those admitted to an inpatient psychiatric unit due to suicide risk. The~     investigators believe that teaching skills to increase positive emotions will lead to better~     problem-solving, increased social support, and other benefits which will serve as protective~     factors and decrease suicide risk.~   "
109774|NCT02130570|"~     The objective of this study is to design and implement a set of procedures (the intervention)~     to improve patients' experiences when they are discharged home from the hospital. Second,~     this study aims to look at how the intervention affects problems that are known to occur~     after discharge, including medication issues, worsening medical problems, or readmission to~     the hospital. The investigators will study how well patients recover the ability to do the~     things they could before they were admitted to the hospital and their opinions of the~     discharge process. Lastly, this study will look to understand the best way to implement the~     intervention into different hospitals and practices, and which types of patients benefit from~     it most.~   "
109775|NCT02130557|"~     Phase 3, 2-arm, randomized, open label trial. Patients will be randomized to receive~     bosutinib or imatinib for the duration of the study.~   "
109776|NCT02130544|"~     Viedo-assisted thoracoscopic surgery(VATS) have became popular in recent years. There is no~     golden rule of postoperative analgesia for VATS. Compared with lobectomy, wedge resection~     preserves better pulmonary function and is suitable for elder patients and patients who could~     not afford to have lobectomy. In addition to surgery time、recovery time and hospital stay,~     wound incisions and organization damages are different,too. Will patients also have different~     response to pain control after these two surgery? The retrospective study is to compared the~     differences of postoperative pain management between VATS lobectomy and wedge resection.~   "
109777|NCT02130531|"~     The purpose of this study is to characterize emixustat hydrochloride pharmacokinetic and~     pharmacodynamic parameters in subjects with geographic atrophy associated with dry~     age-related macular degeneration.~   "
109778|NCT02130518|"~     Long-term indwelling urinary catheters are associated with chronic recurrent urinary tract~     infections and blockage caused by crystalline biofilm accumulation (encrustation) of the~     catheter surfaces. When the urine and catheter are colonized by urease-producing bacteria~     such as Proteus mirabilis, encrustation of the catheter is likely to occur.~      The use of a catheter irrigation solution that can prevent biofilm formation and encrustation~     leading to blockage may keep the catheter patent longer, resulting in fewer catheter changes,~     potentially lower incidence of UTIs and better patient quality of life.~      Auriclosene is a non-antibiotic, fast-acting, broad-spectrum antimicrobial, which exhibits~     potential for the rapid decolonization of a range of urologic pathogens, including the~     urease-producing Proteus mirabilis.~      Subjects will be randomized to either Auriclosene Irrigation Solution or Auriclosene Vehicle~     solution.~   "
109779|NCT02130505|"~     In this study, we will investigate both inflammatory systems in healthy volunteers and~     patients with T2DM on insulin therapy and hyperlipidemia (both familial hyperlipidemia (FH)~     and familial combined hyperlipidemia (FCH)) during an OGTT.~   "
109780|NCT02130492|"~     The objectives of this Pilot study are to investigate the toxicity and safety of high doses~     of [18F]-Fluorodeoxyglucose (FDG) used as a therapeutic agent in patients with advanced stage~     IV malignant tumors that failed standard of care treatment, have a good performance status~     and bear radiosensitive tumors with a high [18F]-FDG uptake.~      The investigators hypothesize that [18F]FDG may have a significant tumoricidal effect on~     cancer cells and radionuclide therapy of cancers with high doses of [18F]FDG administered as~     a single dose or in multiple doses (dose fractionation regimen) can be safe and well~     tolerated with minimal toxicities. Advantages of FDG are its uptake in many different human~     tumors, its short half-life (110 minutes) and the possibility to monitor its effect closely~     with the FDG-PET scan. The rationale for using high doses of this radiopharmaceutical agent~     for treatement is that most malignant lesions have accentuated glucose metabolism, which is~     mirrored by increased uptake of FDG. Since FDG cannot be metabolized within the cell like~     glucose, it is effectively confined within the cancer cells; thus, FDG treatment is~     potentially a novel form of targeted therapy for tumors with increased FDG uptake.~   "
109781|NCT02130479|"~     This study aims to address a serious public health problem (i.e., substance abusing~     adolescents) by testing the effectiveness of a promising substance abuse treatment~     implemented in a community-based treatment setting (CM-FAM, a family-based contingency~     management intervention) in comparison to usual treatment services.~   "
109793|NCT02130323|"~     OBJECTIVE: The standard of care for high grade cervical intraepithelial neoplasia grade 2 to~     3 (CIN 2-3) has been the excision of the cervical transformation zone by way of a loop~     electrosurgical excision procedure (LEEP) or cold knife conization (CKC). However, it has~     been recognized that these procedures can increase the risks for pre-term labor in women who~     still desire to conceive. Recent studies have shown that medical treatment with Imiquimod, a~     topical immune response modulator, has significant effects on histological regression of CIN~     2-3 when compared with placebo. The investigators propose that treatment with Imiquimod may~     be preferable offering similar outcomes on histological regression when compared with~     excision or ablation while potentially avoiding or reducing the number of surgical procedure~     that places them at risk for future pregnancies.~   "
109782|NCT02130466|"~     This is a 5-part dose-finding and preliminary efficacy study of pembrolizumab (Pembro) +~     dabrafenib (D) + trametinib (T) for participants with advanced melanoma. Parts 1 and 2 are~     open-label to find and confirm the maximum tolerated dose (MTD)/maximum administered dose~     (MAD) for Pembro+D+T. The primary hypothesis (Parts 1 and 2) is that Pembro+D+T is~     sufficiently well-tolerated to permit clinical investigation. Part 3 is a double-blind study~     of Pembro+D+T versus placebo+D+T. The primary study hypothesis (Part 3 only) is that the~     Pembro+D+T improves progression-free survival (PFS) compared with placebo+D+T. Part 4 is~     nonrandomized and open-label and is designed to evaluate the safety and tolerability and~     identify the MTD or MAD of Pembro+T in participants who have v-raf murine sarcoma viral~     oncogene homolog B1 [BRAF] mutation-negative (without V600 E or K) melanoma or solid tumors~     [irrespective of BRAF status]. The primary hypothesis (Part 4) is that Pembro+T is~     sufficiently well-tolerated to permit clinical investigation. Part 5 will confirm the dose(s)~     identified in Part 4 in participants BRAF wild type [without V600E or K] melanoma or solid~     tumors [irrespective of BRAF status] and will further evaluate the safety and preliminary~     efficacy (Objective Response Rate [ORR]) of Pembro+T in participants who have BRAF wild type~     [without V600E or K] melanoma only. The primary hypotheses (Part 5) are that Pembro+T is~     sufficiently well-tolerated at the MTD/MAD to permit further clinical investigation and is~     effective in attaining objective responses based upon Response Evaluation Criteria in Solid~     Tumors (RECIST) version 1.1 by Investigator review in participants who have melanoma without~     BRAF V600 E or K mutations.~      Parts 1 and 2 of the study will also explore the MTD/MAD for open-label Pembro+T (for BRAF~     mutation-negative participants) concurrently with the Pembro+D+T arm; Pembro+D (for BRAF~     mutation-positive participants).~   "
109783|NCT02130453|"~     The goal of this clinical research study is to compare regadenoson nuclear stress testing~     with echocardiography strain measurements (an ultrasound imaging method that measures hearts~     function) in detecting coronary artery disease.~   "
109784|NCT02130440|"~     The aim of this study is to evaluate whether treatment with a nasal spray based on~     resveratrol has some benefit in patients with seasonal allergic rhinitis, mild, moderate, or~     severe.~   "
109785|NCT02130427|"~     This pilot study will determine changes over time in tumor volume/motion & patient anatomy,~     as well as dose distributions to normal organs. The study will inform medical decision-making~     about need for (and timing of) re-calibration of radiation dosimetry plans. Weekly CT and/or~     serial MR scans will be employed for those patients receiving 7-8 wks of radiation therapy.~     The study will enroll 30 patients in each stratum: Non small cell lung cancer (NSCLC), Head &~     Neck, gastrointestinal (GI) and Gynecologic tumor.~   "
109786|NCT02130414|"~     The aim of this Phase I, single centre, multi stage study is to evaluate the safety,~     tolerability, pharmacokinetics and relative colonic mucosal concentrations of cyclosporine~     capsules (CyCol®) compared to intravenous cyclosporine in healthy male volunteers.~   "
109787|NCT02130401|"~     This is a pilot study with a single active treatment arm. The study is designed to assess the~     efficacy of a portable, non-invasive neuromodulation system for the treatment of Type 2~     Diabetes. In particular, the primary outcome measure is a reduction in A1c.~   "
109788|NCT02130388|"~     Sepsis is the body's response to a life-threatening infection. This study will determine if~     zinc supplementation is safe to use in patients with severe sepsis or septic shock. This~     study will also gather preliminary information to evaluate the impact that zinc has on the~     immune system (the body's defense system against infection) and whether zinc can help~     monocytes and macrophages (specific types of cells that remove infections from the body) work~     more effectively.~   "
109789|NCT02130375|"~     The purpose of this study is to get the effect of IncontiLaseTM procedure; and its impact on~     urinary symptoms and female sexual function.~   "
109790|NCT02130362|"~     This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in~     pediatric patients with moderately to severely active CD who are treated as recommended in~     the local product label.~   "
109791|NCT02130349|"~     The IBD South Limburg (IBDSL) project was initially designed as a prospective population~     based cohort study. Since 1991, all new IBD cases have been enrolled in the cohort and~     prospectively followed. As from 2011, the cohort is being scaled up into a population based~     biobank and focus expanded from epidemiology towards exploring underlying biologic mechanisms~     and identifying markers to predict disease course or therapy response.~      Every adult IBD patient, diagnosed in and permanently residing in South Limburg (The~     Netherlands), is eligible to participate. The population based nature was reached via a~     multi-faceted approach; incident cases were prospectively identified through the~     participating hospitals, and missed patients were retrospectively identified using the~     nationwide histopathology registry. In 2011, over 3500 patients were included, which~     represents 93% of the IBD population in South Limburg.~      The cohort includes baseline data, such as IBD phenotype, extent, location, behaviour, extra~     intestinal manifestations, medication, surgery, comorbidity and demographics. Data has~     prospectively been updated through chart review (clinical data), questionnaires (i.e. quality~     of life) and linkage to the authority database (vital state, residence). The biobank includes~     serum, plasma, DNA, faeces, biopsies and exhaled air.~      We welcome new collaborations. Applications for collaboration are first to be approved by our~     IBD-SL committee.~   "
109792|NCT02130336|"~     Background. The prevalence of metabolic syndrome (MetS) has been increasing, and its risk is~     positively correlated with age. Due to ageing society in Taiwan, how to treat metabolic~     syndrome and decrease the complications is an important health issue. Relatively few studies~     have been focusing on the effects of exercise training in patients with MetS with long-term~     follow-up. Recently, high-intensity interval training or aerobic interval training (AIT)~     consisting of high intensity separated by active recovery has been proposed to be more~     effective than isocaloric continuous moderate-intensity exercise (CME) in raising exercise~     capacity (VO2max) in some specific patient population.~      Purpose. The purposes are to (1) compare the effects of 16-week CME and AIT on reducing the~     numbers of metabolic risk factors in patients with MetS and the prevalence.~      Hypothesis: 16-week AIT reduces more metabolic risk factors than CME in patients with MetS.~      Methods. This study will be a multiple-center trial. One hundred and twenty patients, aged~     ≥45 years, with a diagnosis of MetS for each center will be recruited. Subjects will be~     randomly assigned to either control, CME, or AIT group after baseline assessments.~     Participants in control group will receive usual care and the others in two exercise groups~     will undergo 16-week exercise training. All subjects will receive 16-week, 6-month and 1-year~     follow-ups including blood test, body composition (body mass index, waist circumference),~     pulse wave velocity, and maximal exercise testing. Statistical analysis will be conducted~     using SPSS 11.5, p < 0.05 indicating statistical significance. Data will be presented in~     mean±standard deviation or number (percentile) with intention-to-treat analysis. Chi-square~     test or one-way Analysis of Variance (ANOVA) will be used to compare whether there are~     between-group differences at baseline. Two-way repeated measures ANOVA and post-hoc test will~     be performed to examine time and group effect if there is interaction effect, otherwise~     Bonferroni will be used. The subgroup analysis between MetS and n-MetS after training will be~     performed using the same statistical methods.~   "
109794|NCT02130310|"~     The primary objective is to evaluate the clinical benefit of CureXcell® as adjunct to~     Standard of Care in the treatment of Chronic Venous Leg Ulcers. CureXcell® is a cell based~     therapy, containing activated homologous white blood cells prepared from donated healthy~     whole blood. A total of 252 patients will be randomized to receive either CureXcell® or~     Placebo.~   "
109795|NCT02130297|"~     The purpose of this study is to evaluate the potential benefits of treating a surgical scar~     post excision with an ablative fractionated CO2 laser with the goal of decreasing the~     appearance and size of the scar.~   "
109800|NCT02130232|"~     The goal of this trial is to investigate the efficacy of a lifestyle intervention of healthy~     diet and physical activity for helping overweight/obese pregnant women to achieve appropriate~     gestational weight gain (GWG) for their prepregnancy body mass index (BMI). The goal of the~     intervention is to help women achieve the lower bound of the GWG range recommended by the~     Institutes of Medicine (IOM) for a given prepregnancy BMI category (i.e., 11 lbs for obese~     women and 15 lbs for overweight women). The lifestyle intervention will be delivered via 2~     in-person counseling sessions and 11 telephone contacts with study dieticians trained in~     motivational interviewing techniques. The lifestyle intervention will be compared to usual~     medical care. Outcomes will be assessed by trained study personnel at approximately 10 weeks~     and 32 weeks gestation, within several days of delivery and at 6 months and 12 months~     postpartum.~   "
109801|NCT02130219|"~     The aim of the study is to evaluate accuracy and precision of non-invasive intracranial~     pressure measurement device (Vittamed 205) for selected patients compared with cerebrospinal~     fluid pressure measured during lumbar puncture~   "
109802|NCT02130206|"~     The purpose of this research study is to investigate the bacterial composition of plaque and~     saliva located in the mouth and associate that with risk factors that cause cavities.~   "
109803|NCT02130193|"~     The aim of this First Time in Patient study is to obtain initial information on the safety,~     tolerability, pharmacokinetics, pharmacodynamics and clinical efficacy of repeat daily~     administration of danirixin in subjects with symptomatic chronic obstructive pulmonary~     disease (COPD) having mild to moderate airflow limitation and are at high risk for future~     COPD exacerbations.~      The study will be conducted in two parts. Part A will be a two week open label, single arm~     study in patients with COPD to obtain pharmacokinetic data and safety information of repeat~     dosing of danirixin in the population of interest. Approximately 10 subjects will be enrolled~     in Part A of the study. Progression to and dose selection for Part B will occur following~     review of the data collected in Part A. Part B will be a 52-week, randomized, double-blind~     (sponsor unblind), placebo-controlled on top of standard of care, parallel group study. Part~     B will evaluate several clinical efficacy assessments related to exacerbations and~     respiratory symptoms. Approximately 100 subjects will be enrolled with a target of 80~     subjects completing 52 weeks of danirixin administration.~   "
109804|NCT02130180|"~     Diabetic ketoacidosis (DKA) is a complication of type 1, or insulin-dependent, diabetes~     (T1DM) and is defined by a high blood glucose level (over 200 mg/dL) coupled with severe~     acidosis. In this state the body breaks down fat tissue for adequate energy production. This~     results in ketone and acid production, and ultimately DKA. Cerebral edema (CE), or brain~     swelling, can also occur with severe DKA. Current evaluation for DKA-related CE necessitates~     a high index of clinical suspicion and often times such patients receive advanced brain~     imaging such as computed tomography (CT) scans.Ocular sonography (ultrasound) is an~     alternative imaging technique that can provide immediate diagnostic capability at the bedside~     and minimize radiation exposure. This technique has been used to rapidly and accurately~     detect increased brain swelling through measurement of the optic nerve sheath diameter (ONSD)~     in a number of clinical situations including pediatric head trauma, hydrocephalus and~     ventriculoperitoneal shunt malfunctions, and altitude sickness in adults. Investigators plan~     to conduct a prospective study including children aged 7-18 years. The objective of this~     study is to assess the utility of sonographic measurements of the ONSD as a tool for~     identification of DKA-related CE.~   "
109805|NCT02130167|"~     Myopia is the leading cause of blindness in Taiwan. The younger children with myopia, the~     higher risk of high myopia in later life and complications such as retinal detachment and~     maculopathy will occur. We have reported the low concentration of atropine (0.05%) with the~     effect on retarding the myopia progression. Recently the 0.01% atropine was also reported~     effective and with less visual side effects such as mydriasis. The aim of this study is to~     compare the efficacy in controlling myopia progression and visual side effects of 2 low~     concentration of atropine(0.05% vs 0.01%) in children aged 6-12 years with myopia of at least~     -0.5 diopters (D) and astigmatism of -1.50 D or less.~   "
109806|NCT02130154|"~     In this study the investigators aim to investigate whether the sympathetic stimulation of~     BAT, as assessed with a 123I-metaiodobenzylguanidine single-photon emission computed~     tomography computed tomography scan, differs between young and elderly subjects, as an~     explanation for the diminished metabolic brown adipose tissue activity in the elderly.~      The investigators hypothesis is that sympathetic nervous system activity in the elderly is~     diminished as compared to their younger counterparts as an explanation for the diminished~     metabolic brown adipose tissue activity in the elderly.~   "
109807|NCT02130141|"~     The evidence linking chocolate with lowered blood pressure has been observed. However, the~     interventions have been short, at most 4 weeks. The aim of this study is to find out if the~     habitual consumption of dark chocolate for 8 weeks has an effect on blood pressure. Also,~     more insight to the mechanisms linking chocolate to individual healt-responses is needed.~   "
109808|NCT02130128|"~     The purpose of this study is to evaluate the safety and performance of the LungPoint ATV~     System in patients who are scheduled for standard bronchoscopy to diagnose highly suspicious~     lung cancer.~   "
109809|NCT02130115|"~     The purpose of this study is to evaluate the safety and performance of the LungPoint ATV~     System.~   "
109810|NCT02130102|"~     In this research project a module based Ambient Assisted Living solution will be provided to~     elderly living in assisted living homes. Those products and services seek to impact quality~     of life of the elderly and have positive effects on their environment.~   "
109811|NCT02130089|"~     The purpose of this project is to understand if more frequent education of dialysis patients~     (patients with kidney failure who get their blood cleaned and fluid removed by a machine~     instead of their kidneys) on reducing sodium intake reduces the amount of fluid weight that~     patients gain between dialysis sessions. Patients who usually gain more fluid than is~     considered ideal will be recruited for this project. Because all patients gain different~     amounts to start, data will be collected for 3 months while the patients receive their usual~     amount of dietitian education. Then the patients will receive intensive (2x/month) education~     on reducing sodium intake from the dietitian and the same data will be collected to see if~     they gain less after the education. After 3 months of intensive education, data will be~     collected for one more month to see if patients keep gaining less or if they go back to their~     old patterns.~   "
109812|NCT02130076|"~     Patients with rheumatoid arthritis (RA) have an increased risk of cardiovascular events. This~     increased risk is thought to be driven by inflammation-induced endothelial dysfunction, an~     initial step in atherogenesis. Treatment with TNFalpha inhibitors (TNFi) improve endothelial~     function in patients with RA. Discontinuation of TNFi could therefore worsen endothelial~     function even in the absence of recurrence of systemic inflammation or reactivation of~     arthritis. If stopping TNFi results in worsening of endothelial function this would strongly~     suggest a higher cardiovascular risk in association with TNFi-wthdrawal~   "
109813|NCT02130063|"~     The purpose of the trial is to evaluate and compare the effect of iron isomaltoside 1000 to~     iron sucrose in its ability to increase haemoglobin (Hb) in subjects with IDA when oral iron~     preparations are ineffective or cannot be used or where there is a clinical need to deliver~     iron rapidly.~   "
109814|NCT02130050|"~     This three-year project aims to~        1. Profile the differentially expressed metabolites in healthy patients with severe~          Obstructive sleep apnea (OSA) before and after six-month continuous positive airway~          pressure (CPAP) treatment~        2. Identify the candidate metabolites involved in biologic pathways attributing to OSA~          phenotyping and response to CPAP treatment~        3. Validate candidate metabolites in the intermittent-hypoxia model of peripheral monocytes~   "
109815|NCT02130037|"~     Background: research show that cognitive behavioral therapy (CBT) is effective inreducing~     bulimia nervosa (BN) and binge eating disorder's (BED) symptoms. Today, with the development~     of technology there are efforts being made for developinga treatment to these eating~     disorders threw the media, most of these attempts are based on the CBT method. The size of~     the effect that CBT given threw the internet has on BN and BED is still not entirely clear.~     Research presented today are mostly based on treatments that were given threw email or~     Skypeor an automatic self- help stage program. These researches show heterogenic results~     about the effect it had on eating disorders. In this research we aim to investigate the~     effect size that a CBT treatment threw a smartphone application that combines a clinician~     online reply and an automatic feedback in addition to astandard ones a week clinic treatment~     has on BN and BED symptoms frequency.~      Methods: Our aim is to make a research using an application that treats that offers an~     automatic and human therapist and dietitian reply threw a similar application that is suited~     for them. A selected 40 BN or sub-threshold BN or BED patients, men and women ages 18-60~     ,that will turn to the Sheba eating disorder medical center will include the research. Half~     of the participants will receive aCBT treatment threw a smartphone application along with~     astandardclinical treatment that includes ones a week session with a therapist and ones a~     week session with a dietitian and the other half will receive a standardclinic treatment~     alone. We will test the eating disorder symptoms using eating disorders questionnaires at the~     starting point, at the end of a six months treatment and six months after finishing the~     treatment.~      Importance: This research will allow testing the need and benefit that a personal and direct~     patient- therapist connection has over a standardones a week meeting connection format. In~     addition, treating with a web application in the future might have a benefit of saving time~     spent on getting to the clinic, will allow to shorten the time of the session in the clinic~     and will save cost of the face to face treatment.~   "
109816|NCT02130024|"~     This study will assess the development of Geographic Atrophy with either ranibizumab or~     aflibercept in patients with wet Age related Macular Degeneration.~   "
109817|NCT02130011|"~     This study will prospectively collect patients undergoing the standard CROSS regimen in the~     neoadjuvant setting of the treatment for gastro-oesophageal cancer. The investigators will~     focus on the potential geometric differences between the OAR and target volume on the initial~     planning CT and on the kilovolt (kV) cone-beam computed tomography (CBCT). They expect a~     potential difference in the abdominal part of the planned target volume (PTV) and/or~     gastro-oesophageal junction part. Furthermore, the impact of gastric filling , potential~     tumor regression and the accuracy of 5 mm PTV margin in the thoracic PTV will be monitored.~   "
109818|NCT02129998|"~     The aim of this study is to achieve a more profound understanding of the endocrine alteration~     in luteal progesterone level after gonadotrophin stimulated IVF/ICSI cycles and to explore~     the optimal progesterone level needed for securing implantation and development of early~     pregnancy.~      The second part of the project will determine the value of Preimplantation Factor (PIF)~     measurement in embryo culture medium as a possible tool for improved embryo selection and the~     use of PIF as an early pregnancy serum marker for healthy implantation and embryo~     development.~      IVF: In vitro fertilisation, ICSI: Intracytoplasmic sperm injection.~   "
109819|NCT02129985|"~     Whether GLP-1 receptor agonists sequential therapy in newly diagnosed type 2 diabetic~     patients can further improve glycemic control, diabetes remission rate and β-cell function~     after the short-term insulin intensive therapy.~   "
109820|NCT02129972|"~     The incidence of Inflammatory Bowel Diseases (IBD) is in a continuous progression both in~     adults as in children. The colonoscopy is considered as the gold standard exam for the~     diagnosis and the follow-up of the patients presenting or suspected to have an IBD. The~     follow-up and financial management of this kind of pathology is very much dependent on the~     quality of the endoscopic images. Because colonoscopy is an expensive and invasive technique~     which assumes a general sedation, many efforts have been done to develop new less expensive~     and less invasive techniques in order to offer alternatives to the classic colon endoscopy.~     One of these new techniques is the colon videocapsule (CVC) endoscopy (PillCam® colon 2 -~     Given Imaging, Yoqneam, Israel). This is a new promising semi-invasive endoscopic technique~     which has been successfully validated with adults. We hypothesize that the CVC can be used in~     children with similar results in terms of efficacy, as is the case for adults.~      This prospective simple blind multicenter study, will investigate the diagnostic value of the~     CVC compared to the conventional colonoscopy under general sedation for the detection and the~     control of colon lesions in children presenting IBD.~      If the feasibility and the efficacy of the colon video capsule technique are also proven for~     use with children, then this new technique might become a very interesting alternative for~     the endoscopic examination of the colon because of being less expensive and less invasive.~      Moreover, this technique would be very useful as a means of lesions detection all along the~     digestive tract and not limited to the colon only.~   "
109821|NCT02129959|"~     The aim of this study is to observe the cardiovascular effects of the degree of head-down~     angle and pneumoperitoneum during laparoscopic procedure using by the fourth version~     Vigileo-Flotrac system.~   "
109822|NCT02129946|"~     The purpose of this study is to determine if consumption of bagels made with resistant starch~     for 8 weeks can improve markers of type 2 diabetes, colon cancer and satiety in adults.~   "
109854|NCT02129530|"~     The overall purpose is to assess whether a community social mobilization (CSM) program~     focused on young men ages 18-35 years of age changes gender norms in the community. The~     secondary purpose is to determine if there is a combined effect of CSM and HPTN 068~     (Conditional Cash Transfers) on HIV and HSV-2 incidence. The goal of the mobilization~     activities is to engage young men around the issues of gender norms, intimate partner~     violence and HIV risk and to encourage them to take action to protect young women and reduce~     HIV risk in their communities.~   "
109823|NCT02129933|"~     To improve detection of esophageal (pre)malignant lesions during surveillance endoscopy of~     patients at risk of developing malignancies, for example in Barrett's Esophagus (BE), there~     is a need for better endoscopic visualization and the ability for targeted biopsies. Optical~     molecular imaging of neoplasia associated biomarkers could form a promising technique to~     accommodate this need. It is known that the biomarker Vascular Endothelial Growth Factor~     (VEGF) is overexpressed in dysplastic and neoplastic areas in BE segments versus normal~     tissue and has proven to be a valid target for molecular imaging. The University Medical~     Center Groningen (UMCG) developed a fluorescent tracer by labeling the VEGF-targeting~     humanized monoclonal antibody bevacizumab, currently used in anti-cancer therapy, with the~     fluorescent dye IRDye800CW. We hypothesize that when bevacizumab-IRDye800CW is administered,~     it accumulates in VEGF expressing high grade dysplasia (HGD) and esophageal adenocarcinoma~     (EAC), enabling early cancer visualization using a newly developed fluorescent NIR~     fiber-bundle. This hypothesis will be tested in this pilot intervention study.~   "
109824|NCT02129920|"~     Early recurrence of cardioembolic stroke in patients with atrial fibrillation is common,~     reaching approximately 6% within 30 days after initial stroke. Therefore, it is preferable to~     provide early anticoagulation for cardioembolic stroke. However, early anticoagulation may~     increase the risk of hemorrhagic transformation of cerebral infarcts. It is difficult to~     decide the timing of initiation for anticoagulant therapy in stroke patients with~     non-valvular atrial fibrillation (NVAF). In 2013 the European Heart Rhythm Association~     presented the practical guides for oral anticoagulants in NVAF patients, which recommend that~     the optimal time to start anticoagulant therapy should be determined according to the stroke~     severity. However, this recommendation is principally an experts' opinion and is not suitable~     in the clinical practice in Japan.~      RELAXED, a multicenter observational study is planned to evaluate the efficacy and safety of~     an oral direct activated coagulation factor Xa inhibitor, rivaroxaban, for acute ischemic~     stroke patients with NVAF in consideration of the infarct size, timing of initiation for~     rivaroxaban medication, and other patient characteristics, and thereby to determine the~     optimal timing of the initiation during acute ischemic stroke. The consecutive acute ischemic~     stroke / transient ischemic attack (TIA) patients with NVAF who are treated with rivaroxaban~     will be enrolled. The infarction size at 0-48 hours after stroke onset will be measured by~     the diffusion weighted image (DWI) MRI. The primary efficacy endpoint is recurrent ischemic~     stroke within 3 months. The primary safety endpoint is major bleedings within 3 months. The~     optimal timing to initiate rivaroxaban during acute ischemic stroke is determined by analysis~     of co-relation between primary endpoints and the infarct size / time to initiate rivaroxaban.~   "
109825|NCT02129907|"~     In total 50 subjects with iron deficiency anemia treated with intravenous iron are planned~     for inclusion in this trial. After signing an informed consent a blood sample will be~     obtained from each participant before iron treatment. The investigators will measure the~     thrombin generation in plasma assessed by the calibrated automated thrombogram (CAT). patient~     will go face to face interview and will be asked to answer structured questionnaire which~     will include information on demographics, clinical data ( fever, allergies , etc.) and~     comorbidities~      Two weeks after completing intravenous iron administration additional blood samples will be~     taken: thrombin generation will be measured~   "
109826|NCT02129894|"~     To see if the use of Abdominal Binders improves patients out comes after cesarean delivery~   "
109827|NCT02129881|"~     A study to assess cell therapy as a treatment to prevent kidney transplant rejection. The~     trial will involve purification of naturally occurring regulatory T cells (nTregs) from~     living-donor renal transplant recipients. The cells will then be grown in the laboratory and~     re‐infused into the patient five days after the kidney transplant. This trial is part of an~     international European Union funded consortium aimed at evaluating cellular immunotherapy in~     solid organ transplantation (The ONE Study). It is anticipated that immune regulation induced~     by nTreg therapy can eventually be used to recude the need for conventional immunosuppression~     in transplant recipients.~   "
109828|NCT02129868|"~     People with type 1 diabetes need regular insulin injections or continuous delivery of insulin~     using a pump. Keeping blood sugars in the normal range is known to reduce long term~     complications. However, achieving treatment goals can be very difficult due to the risk of~     low glucose levels (hypoglycaemia). One solution is to use a system where the amount of~     insulin injected closely matches the blood sugar levels on a continuous basis. This can be~     achieved by what is known as a closed loop system where a small glucose sensor placed under~     the skin communicates with a computer containing an algorithm that drives a subcutaneous~     insulin pump. Previous studies conducted under carefully controlled clinical research~     facility environment, in Cambridge, United Kingdom, as well as several other centres have~     shown that closed-loop glucose control is superior to usual insulin pump therapy. The next~     logical step in the development pathway is to test closed loop systems in the home~     environment. An essential requirement for conducting closed-loop studies outside clinical~     research facility is an automated system where wireless data transmission takes place between~     the glucose sensor and insulin pump.~      The purpose of the present study is to evaluate the efficacy and safety of automated~     overnight closed-loop, in children and adolescents with type 1 diabetes, using a novel system~     which has greatest potential for use in the home setting. The study will take place at a~     clinical research facility on two occasions, using a standardised protocol. The performance~     of the closed-loop system will be evaluated on day 1 of continuous glucose monitoring (CGM)~     sensor life as compared to on days 3 to 4 of sensor life. Data and experience gained from~     this study will be used for further refinements and development of the system for future home~     use.~   "
109829|NCT02129855|"~     The work will evaluate the metabolic costs for daily activities across the lifespan and~     evaluate the influence of having functional impairments.~   "
109830|NCT02129842|"~     The purpose of this study is to assess whether normal endothelial function in patients with~     Atrial Fibrillation undergoing ablation procedure increases the chances of a favorable~     clinical outcome and maintaining sinus rhythm following ablation~   "
109831|NCT02129829|"~     The West African Treatment Cohort for Hepatitis B (WATCH) study is a component of the~     European Commission Funded FP7 project PROLIFICA. It aims to evaluate a number of steps~     required to successfully treat patients with chronic hepatitis B virus infection to prevent~     cirrhosis and liver cancer. The first step is to determine whether screening for hepatitis B~     using a point of care test is feasible and effective. The second is to monitor linkage from~     screening into care. The third is to evaluate cheap non-invasive assessments to determine the~     need for treatment. The fourth is to determine what proportion of patients meet treatment~     eligibility criteria. The fifth step is to establish a treatment cohort which can be used to~     measure adherence to therapy and avoidance of HBV related complications. A parallel untreated~     cohort will be established to determine whether treatment criteria are relevant in this West~     African setting by monitoring for complications of HBV infection.~   "
109832|NCT02129816|"~     Overactive bladder (OAB) is an enigmatic condition that is treated symptomatically with~     anticholinergic drugs (gold standard 2013). In a clinical pilot study was found to be a trend~     for a higher reduction of the micturition frequency in the Bryophyllum pinnatum group -~     treated with chewing tablets containing 50% of dried BP leaf press juice - than in the~     placebo group (n=20, p=0.064) Hypothesis: To test the superior effectivity of Bryophyllum~     versus Placebo in the treatment of OAB with the needed number (Purpose 1) and to assess in an~     experimental arm the side effects of BP in comparison to the standard drug (Vesicare) in a~     clincial trial (Purpose 2).~   "
109833|NCT02129803|"~     This study is a single center, randomized pilot study to evaluate the clinical effectiveness~     of nasal high flow 20LPM humidification therapy in subjects with Cystic Fibrosis.~   "
109834|NCT02129790|"~     Children and adolescents with early-onset bipolar disorder (BD) are at high risk for~     intentionally hurting themselves. Although there are therapies in existence for these youths~     with BD, they do not address suicide prevention specifically. Mentalization-based therapy for~     adolescents (MBT-A) has been shown to be helpful in reducing self-harm in the adolescent and~     adult population with borderline personality disorder. The investigators will modify the~     MBT-A treatment procedures for persons with BD who have had a recent period of suicidal~     ideation or behavior.~   "
109835|NCT02129777|"~     The purpose of this study is to establish proof of efficacy for namilumab in moderate to~     severe plaque psoriasis, measured as Psoriasis Area and Severity Index (PASI)75 response rate~     at Week 12.~   "
109836|NCT02129764|"~     Hyperuricemia is a very common finding in patients with heart failure. It is usually related~     to diuretic use and deteriorated renal function. The recently evidence showed that prednisone~     and allopurinol may have similar effect on uric acid (UA) lowering in symptomatic heart~     failure patients with hyperuricemia, but prednisone may be superior over allopurinol in renal~     function improvement. Thus the investigators design this randomized head to head study to~     test their hypothesis that prednisone is superior over allopurinol in renal function~     improvement despite their similar effect on UA lowering in heart failure patients with~     hyperuricemia.~   "
109837|NCT02129751|"~     Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety~   "
109838|NCT02129738|"~     The purpose of this study is to investigate and document real life safety and satisfaction of~     re-use of urethral catheters for intermittent self catheterization. The study will collect~     re-used catheters from included patients and compare those to a control group with regard to~     bacterial contamination and mechanical properties. A four week prospective evaluation will~     follow where the patients will be given catheters intended for single-use.~   "
109839|NCT02129725|"~     Our research proposal will determine if PDE-5 inhibition exerts a favorable effect on insulin~     signaling pathways in skeletal muscle of subjects with impaired fasting glucose and/or~     impaired glucose tolerance.~   "
109840|NCT02129712|"~     This research will leverage novel pilot research conducted by the investigators to take~     important first steps in addressing neurocognitive late effects by intervening early, during~     treatment, with a promising computerized cognitive remediation program to prevent the~     downward trajectory of neurocognitive function experienced by pediatric brain tumor~     survivors. Specifically, we propose to test the feasibility, acceptability, and initial proof~     of concept of a neuroplasticity-based adaptive cognitive training program (Cogmed) to train~     working memory (WM) and attention in newly diagnosed youth with a brain tumor. Further, we~     will test the feasibility of using this intervention in a true prospective design beginning~     pre-surgery to examine the effects of this intervention in deflecting the downward trajectory~     of cognitive function in children with brain tumors during treatment. We will also use~     functional neuroimaging (near infrared spectroscopy - NIRS) to examine the effects of this~     program on brain activation in frontal regions that are affected by treatment. Findings from~     this pilot study will inform the development of a large multi-site randomized efficacy trial~     to test an individualized cognitive training program.~      Aim 1. To test the feasibility and acceptability of enrolling youth (7 to 16 years-old) with~     newly diagnosed brain tumors at time of diagnosis, following patients for 10 weeks,~     delivering the Cogmed computer-based training program in a randomized trial at 10-weeks~     post-diagnosis, and following patients to 1 year post-diagnosis.~      Aim 2. To test the initial acceptability and efficacy of the Cogmed training program on~     cognitive function in newly diagnosed pediatric brain tumor patients.~   "
109841|NCT02129699|"~     The purpose of this study is to investigate how well the standard treatment (platinum-based~     doublet chemotherapy) in combination with denosumab works compared with the standard~     treatment alone in patients with a type of lung cancer called non small cell lung cancer~     (NSCLC) that has spread to other parts of the body.~   "
109842|NCT02129686|"~     This study is being done to evaluate the potential benefits of using acupuncture to reduce~     symptoms of tingling, burning, numbness and pain in the hands and feet of women with~     peripheral neuropathy after completion of chemotherapy for breast cancer.~   "
109843|NCT02129673|"~     Slow release formulation of latanoprost is compared for safety and pressure-lowering efficacy~     with topically administration of commercially available latanoprost in patient with glaucoma~     and ocular hypertension~   "
109844|NCT02129660|"~     The purpose of the study is to assess the safety of 2 doses of DRM04B compared to 2 doses of~     DRM04 and vehicle (5 treatment arms) for the treatment of axillary hyperhidrosis when applied~     once daily for 4 weeks followed by a 2-week post-dose period.~   "
109845|NCT02129647|"~     The purpose of this study is to determine if the study drug, AXITINIB, has any effect on~     tumors found in patients with Neurofibromatosis Type 2 (NF2).~   "
109855|NCT02129517|"~     This pilot, randomized clinical trial studies a web-based tailored educational program in~     improving nurse communication with patients about clinical trial treatment options. A~     web-based tailored educational program may empower and prepare nurses to discuss clinical~     trial treatment options with patients and may also increase patient participation in clinical~     trials.~   "
109981|NCT02127879|"~     The main purpose of this study is to determine whether intensive repetitive transcranial~     magnetic stimulation (I-rTMS) is effective in the treatment of negative symptoms in~     schizophrenia patients and whether it has a positive influence on their cognitive functions,~     social functions, quality of life, alpha frequency and cortical silent period changes. Also,~     this study should provide data about safety and tolerability this I-rTMS treatment in~     schizophrenia patients.~   "
109846|NCT02129634|"~     Background~      - In patients with critical limb ischaemia (CLI), the infragenicular arteries are often~     involved. Without revascularisation, amputation often is imperative. There is a high~     technical success rate of endovascular revascularisation of infragenicular arteries with~     percutaneous transluminal angioplasty (PTA), but mid- and long-term results are disappointing~     as restenosis frequently occurs. Drug-eluting balloon (DEB) PTA has been shown to improve~     patency rates after PTA of coronary arteries.~      Aim~        -  To study the results of DEB-PTA compared to conventional balloon CB-PTA for the~          treatment of infragenicular lesions in patients with CLI.~        -  To evaluate cost-effectiveness of DEB-PTA versus CB-PTA in patients with critical limb~          ischemia (CLI) by quantifying the incremental cost-effectiveness ratio (ICER).~      Hypothesis~        -  DEB PTA results in improved patency rates compared to CB-PTA for treatment of~          infragenicular arterial lesions in patients with CLI.~        -  DEB-PTA is a cost-effective strategy in patients with CLI compared with CB-PTA.~      Methodology Multi-center, prospective, randomised parallel-group trial. Patients are eligible~     for enrolment if they have CLI and at least one infragenicular lesion with a maximal total~     lesion length of 20cm. Randomisation will be performed on a 1:1 ratio to either DEB-PTA or~     CB-PTA. Patients will be assessed prior and directly after the intervention, at 3, 6 and 12~     months by Rutherford classification, ankle-brachial index, toe pressure and adverse events.~     Duplex will be performed at 3 months. Angiography will be performed before and directly after~     PTA and at 6 months. Primary end-point will be primary patency of the treated lesions at 6~     months on angiography (defined as <50% stenosis, without re-intervention in the interim).~     Secondary end-points are limb salvage at 3, 6 and 12 months, primary patency of the treated~     lesion on Duplex at 3 months (defined as patency of the treated artery with peak systolic~     velocity (PSV) ≤2.0 m/sec), Rutherford classification, minor and major amputation,~     infrapopliteal endovascular re-intervention, patency of treated femoropopliteal sites (if~     applicable), infrapopliteal surgical bypass, peri-procedural complications and death at 3, 6~     and 12 months.~      A cost-effectiveness analysis (CEA) from a societal perspective will be performed in parallel~     with the randomized clinical trial with a 12-month time horizon.~   "
109847|NCT02129621|"~     Aldosterone and its target the mineralocorticoid receptor are implied in development of~     cardiovascular disease such as arterial high blood pressure or cardiac failure. Serum~     aldosterone level is insufficient to know if the mineralocorticoid receptor is activated or~     not. The aim of this study is to identify biomarkers of mineralocorticoid receptor activity.~     The first candidate biomarker is Neutrophil gelatinase-associated lipocalin (NGAL) or~     lipocalin which being measured in blood or in the urine. According to scientific~     knowledge's evolution, others biomarkers could be tested later thanks to the blood or urinary~     samples taken during study.~   "
109848|NCT02129608|"~     Currently in the United States about 97 million adults are considered obese, accounting for~     about 33% of the American adult population (compared to 22.9% in 1988). Obesity, defined as a~     body mass index of 30.0 or higher, is accountable for 44% of the diabetes, 23% of the~     ischemic heart disease and between 7% and 41% of certain cancers. The Erchonia® Zerona™ 2.0~     Laser (which will be used in this study) has been approved by the FDA (K123237) as a~     non-invasive dermatological aesthetic treatment which can be used by individuals intending to~     reduce circumference of hips, waist, and thighs. Lorcaserin is a selective serotonin 2C~     (5-HT(2C)) receptor agonist. The exact mechanism of action is not known, but lorcaserin is~     believed to promote satiety and decrease food intake by activating 5-HT(2C) receptors on~     anorexigenic pro-opiomelanocortin neurons in the hypothalamus. Lorcaserin was approved by the~     FDA on June 2012 for weight management in people with a BMI of > 27 kg/m2 (overweight) when~     accompanied by a weigh-related condition such as type 2 diabetes or high blood pressure or in~     people with a BMI > 30 kg/m2 (obese). The purpose of this pilot study is to obtain~     preliminary data on: 1) effectiveness of the combination of LLLT and lorcaserin for reducing~     abdominal subcutaneous fat in overweight/obese individuals; 2) impact of LLLT on inflammatory~     biomarkers, blood sugar, and cholesterol.~   "
109849|NCT02129595|"~     The main objective of the study is to investigate if resveratrol supplementation can improve~     overall and muscle-specific insulin sensitivity in first-degree relatives of type 2 diabetic~     patients.~      As a secondary objective the investigators want to investigate whether the improved insulin~     sensitivity can be attributed to improved muscle mitochondrial oxidative capacity and a~     reduced intrahepatic and cardiac lipid content. Furthermore, in a subset of the participants~     the investigators want to investigate the effect of resveratrol on glucose uptake in brown~     adipose tissue.~   "
109850|NCT02129582|"~     This phase I trial studies the side effects and best dose of targeted marrow irradiation when~     given with fludarabine phosphate and busulfan before donor progenitor cell transplant in~     treating patients with hematologic malignancies. Targeted marrow irradiation is a type of~     specialized radiation therapy that delivers a high dose of radiation directly to the cancer~     cells, which may kill more cancer cells and cause less damage to normal cells. Giving~     targeted marrow irradiation and chemotherapy drugs, such as fludarabine phosphate and~     busulfan, before a donor progenitor cell transplant may help stop the growth of cancer cells.~     It may also stop the patient's immune system from rejecting the donor's progenitor cells.~     When the healthy progenitor cells from a donor are infused into the patient they may help the~     patient's bone marrow make progenitor cells, red blood cells, white blood cells, and~     platelets.~   "
109851|NCT02129569|"~     This pilot clinical trial studies how well psychoeducational and behavioral strategies work~     in reducing distress and anxiety in patients with multiple myeloma and their family~     caregivers. Education and walking programs, may be able to reduce distress and anxiety and~     improve the well-being and quality of life of patients with multiple myeloma and their family~     caregivers. Understanding how different forms of education and support can promote emotional~     wellness may help nurse researchers find ways to improve services provided to patients and~     family members during cancer treatment.~   "
109852|NCT02129556|"~     A significant amount of preclinical and correlative clinical data suggest that HER2-positive~     breast cancer could be amenable to immune¬therapeutic approaches. The presence of~     HER2-overexpression in breast cancers is associated with higher levels of proliferation, high~     histologic grade and higher levels of tumor infiltrating lymphocytes (TILs) compared with~     HER2-negative tumors. The investigators therefore hypothesize that for HER2-positive tumors,~     avoidance of destruction by the host immune system must be an important mechanism~     contributing to tumor growth and progression.~      The term immune evasion refers to the ability of the tumor to suppress and change host~     anti-tumor immune reactions. The programmed cell death 1 (PD-1) pathway represents a major~     immune control switch which may be engaged by tumor cells to overcome active T-cell immune~     surveillance. The ligands for PD-1 (PD-L1 and PD-L2) are constitutively expressed or can be~     induced in various tumors. High expression of PD-L1 on tumor cells (and to a lesser extent of~     PD-L2) has been found to correlate with poor prognosis and survival in various other solid~     tumor types. Furthermore, PD-1 has been suggested to regulate tumor-specific T-cell expansion~     in patients with malignant melanoma. These observations suggest that the PD-1/PD-L1 pathway~     plays a critical role in the tumor immune evasion and could be considered an attractive~     target for therapeutic intervention in several solid organ types.~      MK-3475 (previously known as SCH 900475) is a potent and highly-selective humanized mAb of~     the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its~     ligands, PD-L1 and PD-L2. MK-3475 strongly enhances T lymphocyte immune responses in cultured~     blood cells from healthy human donors, cancer patients, and primatesMK-3475 also modulates~     the level of interleukin-2 (IL-2), tumor necrosis factor alpha (TNFα), interferon gamma~     (IFNγ), and other cytokines.~      The investigators therefore propose to evaluate if the addition of an immunotherapy can~     reverse trastuzumab resistance and improve clinical outcomes in HER2-positive disease. In~     this study the investigators will determine if a monoclonal antibody targeted against PD-1, a~     T cell negative regulator, can reverse trastuzumab resistance in patients previously~     progressing on trastuzumab.~   "
109856|NCT02129504|"~     Gingival recessions are often successfully treated by coronally advanced flap technique (CAF)~     associated with subepithelial connective tissue grafts (SCTG). Currently the xenogeneic~     collagen matrix (CM) has been used as a substitute for SCTG associated with CAF technique for~     root coverage. CAF technique was not developed for use with CM and has shown limited results~     when applied to the CM. The aim of this study was to compare and show the benefits of the~     extended flap technique (EFT) compared to CAF technique using CM for root coverage.~   "
109857|NCT02129491|"~     Our aim is to establish multi-center national Egyptian database of information about~     cerebrovascular stroke and hemiplegia in infants and children from 0 to 18 years of age.~   "
109858|NCT02129478|"~     Olanzapine is licensed for use in adults in Canada and in teens in the US with mental~     illness. It is also often used for the management of mental illness in children. This study~     will describe the feasibility of giving olanzapine plus other usual medications to prevent~     chemotherapy induced nausea and vomiting (CINV) to 15 children aged 4 to 18 years.~      What has been done already? - In adult cancer patients, olanzapine improved the control of~     CINV. None of the adults studied experienced any serious side effects from olanzapine.~      What is being studied and how will the study be conducted? - On each day that chemotherapy is~     given, olanzapine will be given to 15 children along with their regular medications to~     prevent CINV. Investigators will study each child only during one chemotherapy cycle.~     Participants' blood sugar, liver function tests (AST and ALT), prolactin and triglyceride~     levels, blood pressure, weight, mood and behavior during the time they receive olanzapine~     will be evaluated to see if they change. Investigators will record anything serious that~     happens while children receive olanzapine. If any child stops olanzapine early or decides to~     decrease the dose, the reason will be recorded. Each child and their guardian will record~     their nausea severity and the times they vomit or retch on each day they receive chemotherapy~     and for 8 days afterwards.~      How will the study help? - This study will help investigators decide if it is feasible to~     conduct a larger study to find out if olanzapine improves CINV control in children. If most~     children are able to take olanzapine as set out in the study without having significant side~     effects, then a larger study would be feasible.~   "
109859|NCT02129465|"~     Analysis of several characteristics of blood from pregnant women with CMV infection according~     to maternal-fetal transmission. These include CMV viral load, cytokine profile in response to~     in-vitro stimulation with CMV peptides, meticulous analysis of anti CMV antibodies, maternal~     DNA polymorphism and microarray of gene expression.~   "
109860|NCT02129452|"~     The purpose of this study is to evaluate the olfactory neuroepithelium as a biomarker of~     Alzheimer disease. The early diagnosis of Alzheimer disease is of importance for obtaining~     better response to treatment, but recently reported biomarkers have some limitations.~     Olfactory neuroepithelium tissue which is accessible through office-based biopsy without~     difficulty is known to reflect brain pathology that confirms the diagnosis of Alzheimer~     disease. This study will help in the early detection and treatment of Alzheimer disease.~   "
109861|NCT02129439|"~     Ulcerative colitis (UC) represents one of the major entities of idiopathic inflammatory bowel~     diseases which are defined as chronically relapsing inflammations of the gastrointestinal~     tract not due to specific pathogens. It is characterised by a superficial, continuous mucosal~     inflammation, which predominantly affects the large intestine. The clinical course is~     typically marked by periods of asymptomatic remission punctuated by unpredictable recurrent~     attacks. The symptoms of the patients are marked by persistent diarrhoea with severe faecal~     urgency and often incontinence, rectal bleeding, abdominal cramping and weight loss.~      Uncontrolled activation of mucosal effector T cells has been identified as the main~     pathogenic mechanism involved in the initiation and perpetuation of intestinal inflammatory~     reactions.~      Patients with moderate UC are initially treated with mesalazine, applied both orally and~     rectally. If symptoms do not improve, systemic corticosteroids are to be administered.~     Patients who do not respond to systemic corticosteroids may become eligible for treatment~     with a calcineurin inhibitor or an anti-tumor necrosis factor (TNF)α antibody. Alternatively,~     patients may have to undergo major colorectal surgery.~      Patients who do not adequately respond to these treatment strategies exhibit serious~     drawbacks. Colorectal surgery may result in a severely compromised quality of life.~      Therefore, patients with moderate or severe UC may significantly benefit from new therapeutic~     alternatives.~      The transcription factor GATA-3 is an interesting target for a novel therapeutic strategy in~     UC.~      GATA-3 is the key regulation factor of Th2-driven immune responses. It is indispensable for~     the differentiation and activation of Th2 cells, integrates Th2 signals, and induces Th2~     cytokine expression. Results of a recent clinical trial in children showed that GATA-3 is~     involved in the pathogenesis of the acute phase of UC.~      The investigational product SB012 contains the DNAzyme hgd40 that targets GATA-3. By cleaving~     GATA-3 mRNA hgd40 reduces specific cytokine production and thereby reduces key features of~     mucosal inflammation.~      DNAzymes are completely generated by chemical synthesis, not by use of any living organism~     and are therefore not biological drugs.~      This study will evaluate the efficacy, safety, tolerability and pharmacokinetics of the~     topical formulation SB012 available in a concentration of 7.5mg/ml hgd40 in 30ml PBS once~     daily as a ready-for-use enema in patients with active UC.~   "
109862|NCT02129426|"~     This study will compare 2 different sedation drugs (Ketamine and Midazolam) when they are~     used with another sedating medicine called Dexmedetomidine for MRI sedation. This study hopes~     to measure the impact each drug has on what happens during and after MRI sedation with~     Dexmedetomidine~   "
109863|NCT02129413|"~     The purpose of this study is to evaluate the safety and performance of the Delta system in~     the treatment of cerebral vasospasm post aneurysmal subarachnoid hemorrhage (aSAH) patients.~   "
109864|NCT02129400|"~     The purpose of this study is to analyze the effect of xenon-inhalation on erythropoetin-level~     in blood of healthy volunteers and to determine the efficient time of inhalation.~      Hypothesis: Xenon-inhalation enhances erythropoetin-levels in blood~   "
109865|NCT02129387|"~     The purpose of the proposal is to identify new predictors of smoking progression in young~     light smokers (YLS: 18-25 years & cpd < 5) using an 18-month longitudinal design and to~     relate these predictors of progression to the genetic profile most highly associated with~     smoking progression. A number of novel predictors will be assessed in 128 YLS. Predictors~     will include individual differences (IDs) in EEG, reward sensitivity, attentional~     performance, and mood during abstinence and in response to standardized and to self-selected~     acute nicotine doses (ANIC), as well as genetically influenced affective traits, and smoking~     history. The associations of a compelling genetic functional variant polymorphism,~     rs16969968, in the alpha5 nicotinic receptor subunit will also be related to smoking~     progression and the novel predictors. The study is expected to provide insights into IDs in~     mechanisms and predictors that contribute to smoking trajectories in YLS and thereby lead to~     targeted pharmacotherapy and behavioral interventions for at-risk YLS.~   "
109982|NCT02127866|"~     The purpose of this study is to determine the optimal dose of CHF 5259 (glycopyrrolate~     bromide) on top of Foster which provides the optimal additive bronchodilator effect to~     asthmatic patients whose symptoms are uncontrolled with medium dose of inhaled~     corticosteroids plus long acting beta2 agonists.~   "
109866|NCT02129374|"~     Lumbar spondylolysis is a relatively common condition that causes severe and perennial back~     pain in young populations. Conservative treatment of this condition may be futile, and may~     eventually require surgical treatment such as direct repair of pars defect and a segmental~     lumbar fusion with an anterior or posterior approach. Recently, of surgical treatment methods~     for spondylolysis, direct repair surgery of pars defect has been focused due to its inherited~     strengths. Most importantly, fusion surgery caused the affected segment to lose the nature~     range of motion and furthermore adjacent segment to be adversely affecting such as adjacent~     disc disease or degeneration, while direct repair theoretically could preserve the motion of~     the affected segment, which do not cause the adjacent segment problems as being the fusion~     surgery, as well as could produce better surgical outcomes with relatively less invasive~     technique as compared to fusion surgery. Moreover, previous articles have demonstrated that~     the direct repair surgery for spondylolysis of lumbar spine could achieve great functional~     and radiological outcomes. However, most of the previous studies was conducted using lower~     level designed study such as retrospective and small sample size, thereby prior literature~     does not provide clear information on the therapeutic outcome of direct repair for lumbar~     spondylolysis, especially for managing spondylolysis of young population.~      Therefore, The investigators aimed to evaluate and determine the outcomes of direct repair~     surgery for lumbar spondylolysis in young population. To our knowledge, this is the first~     report that describes the functional and radiological outcomes of direct repair for~     spondylolysis in young populations with prospective cohort study design and relatively large~     sample size.~   "
109867|NCT02129361|"~     This study is investigating one way to improve health and healthy habits after traumatic~     brain injury (TBI). The primary goal of this study is to determine if a brief intervention~     accommodated for persons with moderate or severe TBI is effective in reducing alcohol misuse~     during the year following injury. It is hypothesized that an adapted Screening, Education and~     Brief Intervention (adapted SBI) will reduce the number of alcoholic drinks consumed per week~     over the year following discharge from inpatient rehabilitation, in comparison to a Screening~     and Education Attention Control condition (SEA control).~   "
109868|NCT02129348|"~     Clinically, many patients with AD show no response or minimal response to antipsychotics for~     symptoms of agitation/aggression or psychosis, or they have intolerable side effects on these~     medications. Antipsychotics have a wide range of side effects, including the risk of~     increased mortality (60-70% higher rate of death on antipsychotic compared to placebo) that~     led to an FDA black box warning for patients with dementia; a more recent review and~     meta-analysis showed a 54% increased risk of mortality. In addition, some patients show only~     partial response to antipsychotics and symptoms persist. For these reasons, the investigators~     need to study alternative treatment strategies. Currently, there is no FDA-approved~     medication for the treatment of psychosis or agitation in AD.~      The investigators innovative project will examine the efficacy and side effects of low dose~     lithium treatment of agitation/aggression with or without psychosis in 80 patients with AD in~     a randomized, doubleblind, placebo-controlled, 12-week trial (essentially a Phase II trial).~     The results will determine the potential for a large-scale clinical trial (Phase III) to~     establish the utility of lithium in these patients.~   "
109869|NCT02129335|"~     Glioblastoma multiforme (GBM) is the most common malignant central nervous system (CNS) tumor~     in adulthood with a median survival of 12-16 months. The drastically shorted life expectancy,~     intellectual changes and rapid physical decline in those patients are devastating and do~     impose a profound chronic stress on patients and their families. There is extensive evidence~     that chronic stress can promote cancer growth and progression. In the setting of GBM~     patients, three major questions still have to be answered and will be analysed in this study:~        1. Is there a prognostic significance of stress in patients with newly diagnosed GBM on~          treatment tolerance and (progression free) survival?~        2. Can this stress be modulated by other factors, like stress of patients partners and~          patients physical activity, a known independent prognostic factor in recurrent glioma~          patients?~        3. How is the longitudinal course of patients and partners stress and physical condition~          over the disease course and do they influence (progression free) survival?~      Answers to these questions will help to establish future projects studying non drug~     interventions in patients and patients partners to help improving clinical and tumor related~     outcome in patients with newly diagnosed GBM.~      The investigators hypothesize that chronic stress, specifically measured as a disruption of~     the diurnal cortisol rhythmicity, is an independent prognostic factor in patients with GBM.~     Furthermore, physical activity of patients and stress level in patients` partners may impact~     - as stress-modulating factors- on stress in patients and on their prognosis.~      Aiming at identifying stress-related prognostic factors as potential targets for novel~     treatment approaches, we propose, in a first step, a prospective multicenter cohort study:~     all patients with newly diagnosed GBM and good performance status (KPS ≥ 50%) who undergo~     standard treatment with combined radiochemotherapy with temozolomide (RCT) followed by 6~     month of cyclic temozolomide, are eligible. In addition, one partner, defined as a close~     person living in the same home or close daily contact to the patient, will be asked for~     inclusion.~   "
109870|NCT02129322|"~     The study is designed to investigate the effect of adjuvant therapy by Sorafenib, Oxaliplatin~     and S-1 to prevent the tumor recurrence for hepatocellular carcinoma after liver~     transplantation~   "
109871|NCT02129309|"~     The investigators are interested in studying how Pulmonary Hypertension occurs. A substance~     called 'apelin', that naturally occurs in the body has been shown to have an important role~     in heart disease. Previous studies have shown that it can make blood vessels get wider, and~     help blood flow around the body and thus improve the way the heart and lungs work.~      The investigators are looking to recruit both healthy and COPD pulmonary hypertension~     patients to study 3 types of apelin. The purpose of this study is to help the investigators~     understand how Pulmonary Hypertension occurs which may will help with the development of~     future treatments.~   "
109872|NCT02129296|"~     Gastric balloons are an evolving way of reducing weight. There are two types on the market,~     up to date. Air filled balloons seem to be more safe, and more tolerable.~   "
109873|NCT02129283|"~     The purpose of this study is to determine whether end-of-life training of ICU professionals~     leads to improvements in ICU care process, teamwork and family satisfaction.~   "
109874|NCT02129270|"~     The purpose of this study is to Prove that injection of 15 to 20 mL of lidocaine 1% into the~     fracture site (Hematoma block) is more effective in terms of pain relieving then injection of~     10 mL of lidocaine 2%, and equally safe in terms of complications, for closed reduction of~     distal radius fractures.~   "
109895|NCT02128997|"~     This study will assess whether a negative pressure wound vacuum therapy (NPWT) on closed~     incisions decreases the risk of wound complications among obese patients after cesarean~     section~      All patients having a cesarean section in labor or presenting to the triage unit and~     requiring a cesarean section will be eligible~      Main study intervention: this involves the use of a negative pressure wound vacuum therapy on~     a closed incision.~   "
109875|NCT02129257|"~     The AMALTHEA (Aflibercept MAintenance after first-Line THErapy with FOLFIRI+Aflibercept in~     metastatic colorectal cancer patients) trial is an investigator-initiated, single arm,~     open-label, phase II study. Patients with histologically proven metastatic colorectal~     carcinoma will be treated with a combination of FOLFIRI and aflibercept for 6 months. Both~     Kirsten rat sarcoma viral oncogene homolog (KRAS) wild type (wt) and mutant (mut) patients~     wil be enrolled. In the absence of Progressive Disease (PD) after 6 months of the combination~     of chemotherapy and aflibercept, the patient will be treated with a maintenance therapy with~     aflibercept alone until PD or unacceptable toxicity, investigator's decision or patient's~     refusal of further treatment or death, whichever comes first.~   "
109876|NCT02129244|"~     The researchers of this study are observing the treatment of multi-drug resistant~     Mycobacterium tuberculosis (MDR-TB) in South Africa. MDR-TB can not be treated with the usual~     TB drugs and needs to be treated with special drugs. The patients need to take these drugs~     for up to two years. Certain hospitals have already agreed to participate in this research~     project, half of the hospitals will be assigned a nurse case manager and the other half will~     not. The researchers are studying the benefits of having a nurse case manager to improve~     treatment response for patients with drug resistant TB. The researchers believe that nurse~     case management (NCM) in the intervention sites will increase MDR-TB cure and completion~     rates (i.e. treatment success) in comparison to usual care (UC), i.e. standardized~     programmatic management alone, in patients with and without HIV co-infection. To do this, the~     researchers will review the medical information collected at the hospital as part of the~     patient's treatment after obtaining the patient's permission.~   "
109877|NCT02129231|"~     Aims: To evaluate the effect of ezetimibe/simvastatin and rosuvastatin on oxidative stress~     and mitochondrial function in patients with DPN.~      Methods: We performed a randomized, double-blinded, placebo-controlled phase II clinical~     trial in adult patients with type 2 Diabetes Mellitus (T2DM) who had Diabetic Polyneuropathy~     (DPN) evaluated by composite scores and nerve conduction studies (NCS), HBA1C <12% (108~     mmol/mol), previous exclusion of other neuropathies. Ninety-eight persons with T2DM were~     allocated 1:1:1 to either placebo, ezetimibe/simvastatin 10/20 mg or rosuvastatin 20 mg for~     16 weeks, and healthy controls (not randomized) were included for comparisons. Primary~     outcomes were lipid peroxidation (LPO), nitric oxide (NO), and total antioxidant capacity~     (TAC); secondary were clinical, NCS and metabolic parameters. Results were expressed as mean~     ± standard deviation (SD) or standard error of the mean (SEM), frequencies and percentages.~     Non-parametric analysis was used.~   "
109878|NCT02129218|"~     This pilot clinical trial studies the feasibility of a low glycemic load diet in patients~     with stage I-III colon cancer. A low glycemic load diet includes foods that have low scores~     on the glycemic index. The glycemic index is a scale that measures how much a certain~     carbohydrate causes a person's blood sugar to rise. A low glycemic load diet may help~     decrease the chance of cancer coming back and improve the survival in patients with colon~     cancer.~   "
109879|NCT02129205|"~     To assess the safety and tolerability at increasing dose levels of PF-06650808 in patients~     with advanced solid tumors in order to determine the maximum tolerated dose and select the~     recommended Phase 2 dose.~   "
109880|NCT02129192|"~     To investigate the steady state pharmacokinetics of different formulation of Telmisartan,~     Amlodipine, and Hydrochlorothiazide (HCTZ).~   "
109881|NCT02129179|"~     This study aims to assess the effect of glucagon-like peptide-1 on cardiac output and~     transpulmonary gradient in patients undergoing right heart catheterisation for clinical~     reasons.~   "
109882|NCT02129166|"~     This research study is looking at how imatinib affects how dasatinib is absorbed and~     eliminated from the body. Both imatinib and dasatinib are in a class of medications called~     tyrosine kinase inhibitors (TKI) and they are used to treat certain types of leukemia (cancer~     that begins in the white blood cells). Both imatinib and dasatinib have been given safely in~     healthy volunteers. In this study investigators will evaluate the pharmacokinetics~     interaction between imatinib and dasatinib when they are co-administered. The hypothesis is~     that imatinib will increase the blood levels of dasatinib through inhibiting the drug~     metabolizing enzyme and efflux transporter that are involved in the dasatinib absorption and~     removal. This research will provide important new insight of combination TKI therapy in terms~     of transporter- and enzyme- mediated pharmacokinetic interactions. The research results will~     also help guide doctors in knowing how much of a tyrosine kinase inhibitor to give safely~     while reaching best effect in TKI combination therapy.~   "
109883|NCT02129153|"~     In this study, we will evaluate the efficacy and sustainability of the Linking Families~     Together (LIFT) intervention to improve parental monitoring during the transition from middle~     to high school a particularly risky time for students' academic performance and health~     behaviors. This study is based in middle schools around Los Angeles County a region with a~     high prevalence of teen risky health behaviors.~      The aims of our study are:~        1. To conduct a randomized trial of the LIFT intervention and examine whether providing~          detailed academic information to parents during their child's 7th and 8th grade~          increases parental monitoring at the end of the two year intervention and one year~          follow up. We will partner with 3-10 middle schools and recruit 500 student-parent~          dyads: 250 will be randomized to the intervention arm and 250 to the usual care control~          group.~        2. To determine whether the LIFT intervention improves students' academic outcomes, as~          measured by grades, attendance, and standardized test scores at the end of the two year~          intervention and one year follow up.~        3. To evaluate whether the LIFT intervention lowers rates of adolescent risky health~          behaviors, specifically substance use (alcohol, marijuana, inhalants, and other drugs)~          at the end of the two year intervention and one year follow up.~   "
109896|NCT02128984|"~     The purpose of this study is to determine whether a nutritional supplement is effective in~     the treatment of malnutrition in pediatric patients with failure to thrive or cystic~     fibrosis.~   "
109897|NCT02128971|"~     The purpose of this study is to compare the gastrointestinal (GI) tolerability of 5 different~     iron supplements (Ferrochel®, Sumalate®,ferrous fumarate, ferrous sulfate and ferric~     glycinate) at the same dose (90mg) and placebo.~   "
109898|NCT02128958|"~     This is a multicenter, randomized, double-blind, placebo-controlled clinical trial in~     subjects with advanced HCC and CPB cirrhosis whose disease has progressed while taking 1~     prior systemic drug therapy for HCC.~   "
109884|NCT02129140|"~     The purpose of this study is to evaluate the efficacy of the Cook Biodesign mesh for the~     repair of complex ventral incisional hernias. Using materials to reinforce tissue defects is~     indicated as standard of care for this type of surgery. The Cook Biodesign mesh is currently~     FDA-approved for implantation to reinforce soft tissues where weakness exists, but the~     investigators would like to collect additional follow-up information to continue to assess~     the durability of the repair after placement of the hernia mesh. This follow-up would include~     the collection of information about complications such as infections and seromas (collections~     of fluid around the surgery site), as well as hernia recurrence and quality of life~     questionnaires. Patients who qualify to take part in this study have been diagnosed with a~     ventral incisional hernia and will have been scheduled for a surgical hernia repair. This~     surgery will be an open surgical procedure and reinforcing your tissue with material is~     indicated for this type of hernia repair.~   "
109885|NCT02129127|"~     This first-in-man study is to evaluate the Drug-Coated Chocolate (DCC) Balloon for~     percutaneous arterial angioplasty in patients with symptomatic peripheral arterial disease.~     The study focuses on acute device performance and peri-procedural safety and also seeks to~     further characterize the performance of the device.~   "
109886|NCT02129114|"~     1. Most of dural defects may lead to subcutaneous effusion and Cerebral Spinal Fluid (CSF)~          leakage, which may result in infection; besides, direct adhesion of brain tissues with~          sub-scalp tissues also increase the risk of epilepsy, in severe cases, dural defect is~          considered a life-threatening condition. So, it's important to repair the dura mater for~          restoring its full integrity .~        2. Dural Repair Patch(ReDura Onlay) manufactured by Guangzhou Medprin Regenerative Medical~          Technologies Co., Ltd. As a product made of clinical absorbable polymer materials by~          using bionic technology, Dural Repair Patch has highly bionic 3-dimensional structure~          which is proved to facilitate migration and growth of regenerative cells, as well as to~          accelerate the growth and repairing of regenerative meninges. While the material is~          degraded gradually and absorbed by the body, regenerative meningeal tissue is gradually~          formed, achieving true reconstruction of the dura mater.~        3. To evaluate the safety and effectiveness of Dural Repair Patch in neurosurgical repairs~          of dural defects.~   "
109887|NCT02129101|"~     This phase I/Ib trial studies the side effects and best dose of azacitidine and sonidegib or~     decitabine and so see how well they work in treating patients with myeloid malignancies. The~     hedgehog (Hh) signaling pathway plays an important role in cellular growth, differentiation~     and repair. Inappropriate activation of Hh pathway signaling and uncontrolled cellular~     proliferation may be associated with mutations in the Hh-ligand cell surface receptor Smo.~     Sonidegib binds to the Hh cell surface receptor Smo, which may result in the suppression of~     the Hh signaling pathway and the inhibition of cancer cells. Azacitidine and decitabine may~     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~     Giving azacitidine together with sonidegib or decitabine may be a safe and successful~     treatment for patients with myeloid malignancies.~   "
109888|NCT02129088|"~     The purpose of this study is to compare the pharmacokinetics (explores what the body does to~     the drug), safety and tolerability of esketamine, administered intranasally (administered~     through the nose) in healthy elderly (Cohort 1) and healthy adult (Cohort 2) participants.~   "
109889|NCT02129075|"~     This randomized phase II trial studies how well DEC-205/NY-ESO-1 fusion protein CDX-1401~     (CDX-1401) and neoantigen-based melanoma-poly-ICLC vaccine (poly-ICLC) vaccine therapy work~     when given with or without recombinant flt3 ligand (CDX-301) in treating patients with stage~     IIB-IV melanoma. The cancer vaccine CDX-1401 attaches to a protein that is made in tumor~     cells. The vaccine helps the body recognize the tumor to fight the cancer. The CDX-301~     vaccine may help the body make more of the tumor fighting cells, known as dendritic cells.~     The poly-ICLC vaccine stimulates the immune system and may help these dendritic cells mature~     so that they can recognize the tumor. It is not yet known whether CDX-1401 and poly-ICLC will~     work better with or without CDX-301 in treating melanoma.~   "
109890|NCT02129062|"~     This phase II trial studies how well ibrutinib works in treating patients with B-cell acute~     lymphoblastic leukemia that has come back after treatment or has not responded to other~     treatment. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth.~   "
109891|NCT02129049|"~     This pilot clinical trial studies the feasibility of a telephone-based educational~     intervention in improving communication between patients with stage 0-III cancer and their~     children. An educational program delivered by telephone may help parents talk with their~     school-age child about their cancer.~   "
109892|NCT02129036|"~     Clear cell carcinoma comprises 5-10% of surface epithelial ovarian cancers, and about 30-40%~     of the patients with clear cell carcinoma are diagnosed in the advanced stage. The~     investigators studied the response to chemotherapy and survival for either~     paclitaxel-platinum based chemotherapy or conventional platinum-based chemotherapy among all~     stages clear cell ovarian carcinoma. Prognostic factors for survival among the patients with~     pure, advanced, clear cell ovarian carcinoma were also evaluated.~   "
109893|NCT02129023|"~     The purpose of this study is to examine whether exergame use can improve user health, in~     terms of physical fitness, self-rated mental health and physical health, and favorable~     attitude, strong intention, and actual behavior of future exercise. Moreover, this study also~     examines whether past exercise moderates the impact of exergame use on user health.~   "
109894|NCT02129010|"~     Prospective clinical study to investigate the pathogenesis of Terson syndrome and the~     prognostic value of the CSF-biomarkers tau-protein and amyloid-β 40 and 42 in patients with~     aneurysmatic subarachnoid hemorrhage. Our two hypotheses are as follows:~        1. The incidence of Terson syndrome correlates with the initial intracranial opening~          pressure (measured with extra ventricular drain)~        2. The CSF-biomarkers correlate with the outcome assessed at discharge, 3-, 6- and~          12-months postictally using Glasgow-Outcome-Scale-Extended (GOSE) and Euro-Qol-5 as well~          as with complications related to aneurysmatic subarachnoid hemorrhage such as cerebral~          vasospasm, delayed cerebral ischemia and re-bleed.~   "
109958|NCT02128178|"~     Obese patients undergoing bariatric surgery warrant VTE prophylaxis because they are at high~     risk for developing a fatal pulmonary embolism or postthrombotic syndrome. However, a~     consensus does not exist on the most effective prophylactic approach.~   "
109899|NCT02128945|"~     The application of positron emission tomography with lymphoproliferative diseases today~     provides diagnostic and therapeutic information of major importance , especially in terms of~     speed and quality of response to treatment. The radiopharmaceutical used in clinical practice~     for this exam is fluorodeoxyglucose 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose~     ([18F]-FDG) . However , the uptake of this tracer is not elective in lymphoid tissues , with~     a lack of specificity. In addition , the avidity of this tracer is unequal according to the~     histological subtype (lack of sensitivity).~      To try to improve the results of this clinical exploration of lymphoid malignancies, the~     investigators developed a new radiopharmaceutical ( [18F] - fludarabine ). The idea of~     transforming the fludarabine radiopharmaceutical is based on the existence of a fluorine atom~     in the molecule and the pharmacokinetic characteristics of this drug. The [18F]-Fludarabine~     is a new radiopharmaceutical reproducing the same dosage formulation of fludarabine , a drug~     used for the treatment of certain types of lymphoproliferative diseases, especially those~     where the tumor cells have a low proliferation kinetics . This drug is used in therapy in~     particular pharmacokinetic effect for a high affinity for the lymphoid tissue . Preclinical~     results on normal and lymphoma xenograft -bearing mice showed a specificity restricted to~     lymphoid tissue fixation with [18F]-Fludarabine compared with [18F]-FDG .~      Based on these encouraging results , the investigators propose in this work to explore the~     Dosimetry and Biodistribution of [18F] - Fludarabine in human lymphoproliferative diseases :~     1)A first group of patients with non-Hodgkin's large cell lymphomas in which it already has a~     wealth of experience in exploration [18F]-FDG, and 2) a second group of patients with chronic~     lymphocytic leukemia, where the results of the exploration [18F]-FDG are considered~     disappointing and did not, for this reason, experienced clinical development.~   "
109900|NCT02128932|"~     This trial is conducted in Africa, North and South America, Asia and Europe. The purpose of~     the trial is to compare the effect of once-weekly dosing of two dose levels of semaglutide~     versus insulin glargine once-daily on glycaemic control after 30 weeks of treatment in~     insulin-naïve subjects with type 2 diabetes.~   "
109901|NCT02128919|"~     This is a study of the effects of tDCS on smoking, craving for cigarettes, cognition, and~     psychiatric symptoms in schizophrenic patients who are current smokers or have a history of~     regular cigarette smoking. It assesses smoking with CO monitoring, nicotine and nicotine~     levels, and craving with QSU scale and response to craving slides. Cognition is measured by~     MCCB, symptoms are measured by PANSS and hallucination scale.~      This is a double-blind sham-controlled study with active tDCS 2ma or 20 minutes over 5 days,~     and sham tDCS for 40 seconds on each sham occasion.~   "
109902|NCT02128906|"~     The goal of this clinical research study is to learn which chemotherapy combination may be~     more effective in treating locally advanced head and neck squamous cell carcinoma (HNSCC).~     The side effects of these combinations will also be studied.~      This study treatment consists of intensity-modulated radiation therapy (IMRT) and concurrent~     chemotherapy. For study chemotherapy, patients will be randomized between cisplatin or the~     combination of docetaxel and cetuximab. Subjects will be stratified depending on HPV status~     and the presence of ERCC-1 [4F9] in the tumor prior to randomization. The study will evaluate~     cisplatin vs. docetaxel-cetuximab in the overall population, and test which radiation and~     chemotherapy combination works best in relationship to how much ERCC-1 [4F9] is expressed in~     a tumor.~   "
109903|NCT02128893|"~     The purpose of this study is to assess the effect of multiple doses of esomeprazole on the~     pharmacokinetics of isavuconazole. In addition, safety and tolerability of isavuconazole~     alone and in combination with esomeprazole will be assessed~   "
109904|NCT02128880|"~     The goal of the proposed research is to develop and pilot test a novel Internet intervention~     to reduce the risk of Alcohol-exposed pregnancy (AEP). Efficacious interventions to reduce~     the risk of AEP have been developed, but are not widely available. In this project, we will~     develop a novel Internet intervention to reduce AEP risk by combining the resources of two~     research teams focused on primary prevention of Fetal Alcohol Spectrum Disorders (FASD) and~     robust Internet interventions, respectively. We will use our evidence-based AEP risk~     reduction intervention materials and our existing Internet intervention development platform~     to build and pilot test an Internet intervention (Contraception and Alcohol Risk Reduction~     Internet Intervention, CARRIII) in a stage 1 behavioral and integrative therapies development~     project.~      This three year R34 project will develop and program the new Internet intervention, and will~     determine the feasibility and preliminary efficacy of the intervention in a pilot RCT. In~     this protocol, we will assess the feasibility and preliminary efficacy of CARRIII against a~     Patient Education Website condition in a pilot randomized clinical trial (RCT) with~     assessments at pre-, post-, and 6 months.The primary hypothesis is that women randomized to~     the CARRIII condition will change more in 3 markers of AEP-related outcomes (risky drinking,~     ineffective contraception, and AEP risk) than women assigned to the Patient Education website~     condition. We will prepare for a future cost effectiveness evaluation in the larger RCT to~     follow by pilot testing proposed measures. The pilot RCT will yield effect size estimates for~     a subsequent fully powered trial. If the Internet intervention is promising, it should be~     tested in a fully powered national trial. The Internet intervention could substantially~     increase the options for AEP prevention, and could lead to a reduction in incident FASD.~   "
109905|NCT02128867|"~     The purpose of this study is to determine whether three airway clearance techniques (~     Bouncing, Assisted Autogenic Drainage ( AAD) and bouncing and AAD) provoke or aggravate~     gastro-esophageal reflux in infants under the age of 1 year.~   "
109906|NCT02128854|"~     The purpose of this project is two-fold: (1) to determine the feasibility of recruiting rural~     African American (AA) adults in South Carolina (SC) for assessing the usefulness of~     tablet-based resources in good diabetes self-management behaviors, and (2) to test a~     tablet-aided intervention for improving diabetes self-management behaviors~   "
109907|NCT02128841|"~     Objectives~      Primary objective:~      To determine if rivaroxaban (Xarelto) is feasible and safe for prevention of major~     complications in patients undergoing a mechanical aortic heart valve replace-ment.~      Secondary objectives:~      To identify the value of molecular markers suitable for monitoring of anticoagulation~     effectiveness of rivaroxaban and its correlation with transcranial Doppler emboli count in~     patients undergoing a mechanical aortic heart valve replacement.~      Design This is a prospective, open-label phase 2 pilot study with independent evaluation of~     all outcomes and a historical control group.~      Number of patients 30 in experimental group (patients in the center's registry database serve~     as control group).~      Main eligibility criteria All patients between 18 and 70 years old receiving a mechanical~     aortic valve replacement with a pre-operative left ventricular ejection fraction >/=35%.~      Interventions Experimental: Rivaroxaban 20mg p.o., once daily, for six months Historical~     control: Phenprocoumon (Marcoumar) p.o., once daily Outcomes~      Primary outcome:~      Composite outcome of prosthetic thrombus requiring reoperation/intervention, major bleeding,~     visceral ischemia, stroke, pulmonary embolism, myocardial infarction or death from any cause~     180 days after intervention.~      Secondary outcomes:~      Each component of the composite outcome plus serious adverse events. Prosthetic thrombus~     requiring reoperation/intervention plus non-clinically relevant thrombi will be used as an~     additional safety outcome.~      Molecular markers suitable for monitoring the effectiveness of rivaroxaban.~   "
109908|NCT02128828|"~     The study hypothesis is that cenicriviroc will improve cognition in HIV infected individuals~     with cognitive impairment. The investigators will study the effect of cenicriviroc on~     cognition in 24 subjects over a 24 week period.~   "
109959|NCT02128165|"~     The aim of this study is to compare the efficacy of gastric balloon in weight reduction among~     two different categories of morbidly obese people.~   "
109909|NCT02128815|"~     Background: Health coaching is defined as health education, promotion and support by a~     professional to enhance the well-being of individuals and facilitate the achievement of their~     health-related goals. However, health coaching has not been adequately assessed in the~     community health care setting in individuals with T2DM. The purpose of this study is to~     determine the effect of diabetes health coaching in adults with T2DM in the community health~     care setting on clinical outcomes, self-care behaviours and health care utilization.~   "
109910|NCT02128802|"~     Gastric Bypass followed by renal transplantation is superior to medical management followed~     by renal transplant for patients with severe obesity and renal failure.~   "
109911|NCT02128789|"~     Technology has been created to help older adults age well in their homes, but adoption and~     acceptance have been slow. The researchers are developing a low-cost web-based technology,~     called Elder Tree, for older adults and caregivers to address key challenges older adults~     face, such as loneliness and isolation, falls, loss of driving privileges, relapsing from~     proven falls prevention strategies, and unreliable home services. Elder Tree is being~     developed and tested with older adults and caregivers to identify, 1) usability issues such~     as font size, navigation and interface (audio, video,text) and 2) content and tailoring~     issues such as identifying local resources and events. This study will employ a randomized~     longitudinal design comparing a control group to an intervention group over a 12-month~     period. Investigators hypothesize that older adults using Elder Tree will experience greater~     independence and quality of life when compared to the control group. Investigators will use~     quantitative measures to determine how much our intervention improves: quality of life and~     health system use. These measures will help us to determine the cost effectiveness of Elder~     Tree. Investigators will recruit and test Elder Tree in 3 Regional Aging and Disability~     Resource Centers; one urban, one suburban and one rural setting, so to account for~     environmental and community differences. The older adult and their caregiver will be~     randomized to the same treatment group. Investigators will measure the effect over the 12~     month intervention period and a 6 month follow-up period at 18 months.~   "
109912|NCT02128776|"~     The purpose of this study is to assess whether an enhanced medical home providing~     comprehensive care is cost-effective in preventing serious illness (death, pediatric~     intensive care admission, or hospital stay >7d) among high-risk chronically ill children.~   "
109913|NCT02128763|"~     The objective of the DREAM study is to evaluate the effectiveness and safety of~     supplementation with omega-3 fatty acids in relieving the symptoms of moderate to severe dry~     eye disease.~   "
109914|NCT02128750|"~     The primary objective of our work is to show that quantification of muscular~     microvascularisation evaluated by injection of contrast agent is different between chronic~     critical limb ischemia (before revascularization) and after (healing of ischemia) and thus~     make the proof of its utility in evaluation of PAD therapeutics.~   "
109915|NCT02128737|"~     This project continues an innovative line of research on how to optimally use sleep as an~     intervention to promote cognitive recovery from, and resistance to, the neurobehavioral risks~     posed by chronic partial sleep deprivation. Chronic insufficient sleep is estimated to affect~     at least 20% of adults. It can result from medical conditions and sleep disorders, as well as~     work demands, and social or domestic responsibilities. It is associated with significant~     clinical morbidity, and directly causes errors and accidents that are due to its adverse~     neurobehavioral effects on alertness, mood, and cognitive functions. In seminal experiments~     conducted under this grant, we showed that the neurobehavioral effects of chronic sleep~     restriction accumulate to severe levels in a few days, without the full awareness of the~     affected individuals, and that recovery from chronic sleep restriction requires more sleep~     than previously assumed. We also discovered that recovery from chronic sleep was illusory,~     because it masked a heightened neurobehavioral vulnerability to even a single post-recovery~     night of sleep restriction. The implications of these findings are that apparent recovery~     from chronic sleep restriction masks a more severe cognitive response to subsequent sleep~     restriction suggesting that there are longer time constants in the brain for neurobehavioral~     recovery from chronic sleep restriction. In light of this finding, we now seek to determine~     whether additional nights of extended recovery sleep will reduce the heightened vulnerability~     induced by prior exposure to sleep restriction. A total of 87 healthy adults (ages 21-50)~     will be studied in the laboratory during a 17-night (N=63) and a 19-night (N=24) protocol~     evaluating cognitive, psychological and physiological responses to varying recovery days~     between two sleep-restriction periods. The results will establish the number of nights of~     recovery sleep needed to prevent accelerated deterioration during a subsequent period of~     sleep restriction. The findings will advance theoretical understanding of sleep homeostasis~     and its relationship to cognitive functions, as well as inform theories of sleep need, and~     have substantial implications for sleep biology, for the treatment of clinical disorders that~     regularly disrupt sleep, and for managing lifestyle factors that frequently restrict sleep.~   "
109916|NCT02128724|"~     This study will test whether a drug called BKM120 is a safe and effective treatment when~     given to lung cancer patients having radiotherapy treatment. The trial will identify which of~     three possible doses of BKM120 is best to give with lung radiotherapy.~   "
109917|NCT02128711|"~     There is plenty of evidence to suggest that the lung is not uniform. The internal surface~     area is 30 times that of skin, and the different bronchioles/bronchi/alveoli differ greatly~     in blood perfusion, temperature, oxygen tension, and pH. Also, particularly in the context of~     respiratory disease, notable differences are present in the structure of epithelial cells,~     cilia, production of mucus, and inflammatory/immune responses. All of these factors are known~     to impact the physiology of bacteria, yet, there is very little understanding of how they~     impact a) the presence/absence of particular bacterial species throughout the respiratory~     tract, or b) the metabolic processes used by these bacteria within the human host~     environment. A greater understanding of the relationships between environmental (chemical)~     gradients in the lungs of diseased patients (particularly those with cystic fibrosis) and the~     microbial communities that are present may lead to novel hypotheses about manipulation of the~     respiratory environment for therapeutic benefit. To investigate this further, the~     investigators propose to use explanted lung specimens from cystic fibrosis patients to test~     the following hypothesis:~      Hypothesis: In patients with cystic fibrosis, bacterial community composition, metabolism and~     environmental chemistry will vary depending on their spatial location within the airways.~   "
109918|NCT02128698|"~     The purpose of this study is to determine wether regular physical activity in combination~     with protein supplementation after bariatric surgery can reduce the loss of muscle mass and~     wether a computer-assisted exercise program is more effective than a usual exercise program~     regarding frequency of physical activity, fitness and muscular strength.~   "
109919|NCT02128685|"~     The aim of this study is to determine whether the dydrogesterone therapy is associated with~     reduction in miscarriage in women with first trimester threatened miscarriage. The hypothesis~     is that the dydrogesterone therapy will significantly reduce the risk of miscarriage in women~     with threatened miscarriage.~   "
109983|NCT02127853|"~     Gabapentin pretreatment may reduce hyperalgesia occurring at the second surgery in serial,~     bilateral cataract surgery.~   "
109920|NCT02128672|"~     Spinal cord stimulation (SCS) has been used for almost 30 years to treat many intractable~     back pain conditions. It has demonstrated efficacy in the co-called Failed Back Surgery~     Syndrome (FBSS) and a recent randomized controlled trial demonstrated significant superiority~     of SCS over conventional medical therapy to treat patients with FBSS. Another trial has~     demonstrated superiority of SCS over repeat surgery in the same patient population. However,~     the ability to reliably capture the low back with paresthesia coverage has remained~     challenging and elusive despite numerous strategies designed to overcome this limitation.~     Strategies that have been introduced but so far with limited success include transverse~     multiple lead stimulation, high frequency stimulation, peripheral field stimulation, and~     dorsal root ganglion (DRG) stimulation. To date, none of these strategies have been able to~     reliably overcome the long-term problems of paresthesia capture and pain relief of the low~     back.~      This proposal describes a new spinal stimulation technique designed to improve the likelihood~     of low back stimulation by targeting the nerve supply to the two most commonly affected pain~     producing structures in the back, the facet joints and the intervertebral disks. The~     technique has proven to be feasible in a cadaver model with ease of lead placement at the~     desired targets~   "
109921|NCT02128659|"~     The purpose of this study is to learn if a cervical health literacy program is a practical~     and helpful way of improving women's cervical health knowledge and improving cancer screening~     behaviors, and ultimately preventing cervical cancer.~   "
109922|NCT02128646|"~     The purpose of this study is to learn how well Liposomal Bupivacaine (Exparel™) controls~     post-operative pain in patients undergoing both open and laparoscopic (minimally invasive)~     abdominal hernia repair surgery.~   "
109923|NCT02128633|"~     Aim: To evaluate the effectiveness of a desensitizing gel for topical and home use in the~     treatment of dentin hypersensitivity (DH) through a randomized clinical trial, double-blind,~     with three parallel treatment. Methods: 126 subjects were divided into three groups: placebo~     gel (PG), test gel (TG) (5% sodium fluoride, potassium oxalate 5%, strontium chloride 10%)~     and sodium fluoride gel (2% FG ). The measurement of DH was performed by a single examiner~     blinded by the visual analog scale (VAS) after tactile, thermal and osmotic stimuli in the~     Baseline, 7, 15 and 30 days.~   "
109924|NCT02128620|"~     The objective of this project is to assess the impact of a Game-Based Appointment System on~     both, the clinical settings, and on the use of the educational web app www.sjekkdeg.no.~      An A/B testing methodology will be used. This methodology consist on the redirection of the~     users to two different versions of the website, and therefore allows to assess the~     interactivity of the users according to the design of the webpage and determine which one has~     a higher impact on the clinical settings, and consequently on prevention of STDs.~      For the A/B test we will test the interactivity of two versions of a web page~     www.sjekkdeg.no: the A version (control), consisting en the educative web app; and the B~     version, consisting in the web app www.sjekkdeg.no including the Game-Based Appointment~     System.~      The Game-Based Appointment System will offer the users the option of booking appointments at~     the venereology department at the University Hospital of North Norway. The system will~     include an automatic priority appointments function, with three levels of prioritization~     (triage): 1) Emergency-appointment: The user should go to the doctor on the same day or the~     following day. 2) Haste-appointment: Within 3-4 days; or 3) Routine-appointment: within 2-3~     weeks.~      The hypotheses of this research project are:~        1. The number of visits with the health professionals will be larger in the game-based~          appointment group than in the control group.~        2. The number of visits to the educative components of www.sjekkdeg.no will increase after~          the launch of the Game-Based Appointment System functionality.~        3. The number of visits to the educative components of www.sjekkdeg.no will be larger in~          the appointment group than in the control group.~        4. The time spent per visit to the website will be larger in the appointment group than in~          the control group, meaning a higher exposure to health information.~        5. The visitors returning rate is larger in the appointment group than in the control~          group.~   "
109925|NCT02128607|"~     Objectives:~      Determine the efficacy of the SNAG technique (Mulligan) applied to a subgroup of people with~     non-specific low back pain (LBP) on two new kinematic-algorythms, on pain, functional~     disability and kinesiophobia.~      Design:~      A randomized double blinded placebo controlled trial with double arms in accordance with the~     CONSORT statement.~      Subjects:~      Patients with non-specific low back pain will be recruting from Saint-Luc hospital, only a~     subgroup of them will be included according to specific inclusion criteria tailored for~     indication of application of SNAG's therapy (Mulligan technique applied on the lumbar spine).~      Method:~      Subjects will be randomized in 2 groups; real-SNAG and sham-SNAG groups. All patients will be~     treated during a single session, and real/sham SNAG will be applied from a sitting position~     with the belt, and in a flexion direction. Two kinematic-algorythms (ROM and Speed) from a~     validated kinematic spine model will be used and recorded with an opto-electronic device~     (BTS-Elite). Pain at rest and during flexion, as well as functional disability and~     kinesiophobia will be recorded by self-reported measures. These outcomes will be blindly~     evaluated before and after treatment to compare both groups with  Two-Way-ANOVA  statistic~     with for factors; time and groups.~   "
109926|NCT02128594|"~     Men who have sex with men make up a majority of incident HIV infections, however few~     effective interventions to prevent HIV transmission among this group exist. African American~     men who have sex with men (AAMSM) are disproportionately infected with STI/HIV and little is~     understood about how the role of stigma impacts their linkage and retention to health care~     during treatment. Effective strategies for reducing HIV related risk taking are urgently~     needed to prevent further spread of the HIV epidemic. The proposed research will test a~     behavioral intervention, which can be used during routine public health services, designed to~     reduce HIV risks posed by sexual partner selection strategies. The proposed research will~     also identify treatment barriers among MSM who test HIV/STI positive. Effective strategies~     for reducing social barriers to health care treatment rely on a comprehensive and thorough~     investigation into social barriers that affect AAMSM to effectively engage in medical care.~     These areas of research will be focused on for the current trial.~   "
109927|NCT02128581|"~     Exendin-(9,39) has been shown to have effects on beta-cell function, and after gastric~     bypass, to accelerate gastrointestinal transit. - infused at rates of 300pmol/kg/min. Given~     that gastrointestinal transit is typically delayed by Glucagon-Like Peptide-1 (GLP-1) and~     also that this hormone causes decreased food intake through increased satiation, it is~     reasonable to expect an effect of Exendin-9,39 on appetite. This may help explain the effects~     of gastric bypass on food intake. To examine the effect of Exendin on food intake we propose~     a dose-response study to determine whether the compound has effects in a dose-dependent~     fashion. We will examine the presence of gastrointestinal symptoms as well as food intake in~     the immediate aftermath of a test meal and the subsequent hours.~   "
109984|NCT02127840|"~     The project is aimed to determine the value of synacthen infusion on the results of adrenal~     venous sampling in patients examined for primary aldosteronism~   "
112740|NCT02091765|"~     The purpose of this study is to evaluate the efficacy and cost-effectiveness of an~     internet-based cognitive behavioural therapy program in alleviating problems with intimacy~     and sexuality in women treated for breast cancer.~   "
109928|NCT02128568|"~     This research is a continuation of the Youth Readiness Intervention (YRI) randomized clinical~     trial by adding additional pre and post intervention data collection upon treatment of the~     control group (N=222) with the intervention which was proven effective in the larger trial.~     The overall research has investigated whether participation in the YRI intervention will~     improve emotional regulation, prosocial attitudes/behavior, social support and daily and~     functioning among war-affected 15-24 year olds in Sierra Leone. In this sub-study which will~     involve treatment of the control group with the effective YRI intervention, the investigators~     will add an additional measure of self-regulation as observed via DNA methylation in buccal~     cells collected via cheek swabs. As before, after the YRI intervention, youth will be offered~     a free educational opportunity at the EducAid program in Freetown or in one of its~     upline/provincial sites. This stage of the research, as in the treatment with the main group,~     will test whether youth enrolled in the YRI psychosocial intervention go on to demonstrate~     improved attendance and behavior in a subsidized education program. In the previous phase of~     the trial, the investigators did observe significant effects for the YRI intervention and~     evidence that the program is indeed effective. For instance, post-intervention, YRI youth~     reported greater improvements in emotion regulation (β=0.109, 95%CI 0.026 to 0.191, δ=0.31),~     prosocial attitudes/behaviors (β=0.149, 95%CI 0.057 to 0.240, δ=0.38), and social support~     (β=0.119, 95%CI 0.009 to 0.229, δ=0.26) than controls, and greater reductions in functional~     impairments (β= -0.175, 95%CI -0.299 to -0.050, δ= -0.35). Differences in symptoms were~     non-significant at six-month follow-up for the full sample; moderator analyses showed that,~     for individuals in the top quartile of baseline symptoms, YRI youth had greater improvements~     in emotion regulation and social support than controls. At eight-month follow-up, teachers~     reported that YRI participants were 8.9 times more likely to be in school (28.8% v. 4.7%) and~     showed better attendance (β=3.553, 95%CI 0.989 to 6.118, OR=34.93) and academic performance~     (β= -0.954, 95%CI -1.807 to -0.102, δ= -1.31).~      In this final phase of the trial as the investigators treat the wait list control group, the~     investigators will test whether intervention effects observed in self-report data on improved~     emotion-regulation are also upheld in biomarker data. Thus, the investigators will now~     provide YRI treatment to the wait list control group and employ the use of biomarkers as a~     measure of the intervention's effectiveness. The objective of the study will be to assess~     whether DNA methylation (collected via cheek swabs of buccal cells) is associated with~     changes in emotion regulation pre- and post- intervention. The aim is to test the hypothesis~     that the YRI is associated with improvements emotion-regulation evidence both in self-report~     data on emotion-regulation and in buccal cell DNA methylation. This study will add to the~     evidence base for effective, culturally sensitive mental health services for youth and young~     adults affected by war and other forms of adversity.~   "
109929|NCT02128555|"~     The purpose of TARVA is to determine whether Total Ankle Replacement (TAR) provides better~     clinical outcomes than ankle arthrodesis in patients aged 50-85 years with end-stage ankle~     osteoarthritis, and compare cost-effectiveness of the two treatments~   "
109930|NCT02128542|"~     This study will examine the safety, tolerability, and antiviral efficacy of sofosbuvir~     (SOF)+ribavirin (RBV) in treatment-naive and treatment-experienced United States Veterans~     with compensated cirrhosis and genotype 2 HCV infection.~   "
109931|NCT02128529|"~     The purpose of this study was to investigate the prevalence of chronic bronchitis in patients~     suffering from moderate to very severe chronic obstructive pulmonary disease (COPD), and to~     assess the difference in exacerbation rates in patients suffering from moderate to very~     severe COPD with chronic bronchitis vs. a population of patients without chronic bronchitis.~   "
109932|NCT02128516|"~     this clinical trial would try to confirm whether NUTRALYS®, a fast pea protein with an~     intermediate profile, rich in leucines and other essential amino acids, can significantly~     enhance muscle mass gain during strength training. This study will compare the efficacy of~     NUTRALYS® to a reference product. If the results of the study demonstrate a significant~     improvement in relation to the placebo, not inferior to that of whey, NUTRALYS® could be~     considered as an alternative to sports nutrition products, to which many people are~     intolerant.~   "
109933|NCT02128503|"~     This study aims to determine the prevalence of HBV infection in patients with IBD and~     rheumatologic disease, and to assess the impact of immunosuppressive therapy on viral load~     and clinical course of IBD patients.~   "
109934|NCT02128490|"~     The purpose of this study is to evaluate the efficacy and safety of febuxostat 40 mg extended~     release (XR) and 80 mg XR in comparison with febuxostat 40 mg immediate release (IR) and 80~     mg IR, respectively, in gout participants with moderate renal impairment.~   "
109935|NCT02128477|"~     Increased periodic repolarization dynamics (PRD) indicate increased risk of death in cardiac~     patients. This study thoughts to prospectively validate the prognostic value of PRD in~     post-infarction patients.~   "
109936|NCT02128464|"~     Customized cutting block and conventional cutting guide are both effective in improving~     accuracy and function of OA knee patients.~   "
109937|NCT02128451|"~     The use of clonidine as an alternative to epidural opioids offers several potential benefits.~     Clonidine does not have respiratory depressant effects, and the incidence of vomiting and~     pruritus is less frequent compared with that seen after administration of epidural morphine.~      Epidural clonidine have focused on the optimal doses of clonidine to be used, rather than~     analyzing the potential advantage of using epidural clonidine versus opioids with respect to~     efficacy and incidence of side effects.~      Epidural fentanyl has been used effectively as an alternative to morphine and has been shown~     to induce fewer complications when compared with epidural morphine. However, the incidence of~     vomiting in patients receiving epidural fentanyl still ranges between 28% and 52% depending~     on the study population and concentration used. The analgesic and side effects profile of~     epidural clonidine compared with epidural fentanyl are unknown.~      The primary aim of this randomized double-blind trial is to test the hypothesis that epidural~     clonidine decreases the incidence of side effects compared with epidural fentanyl.~      Therefore, we compared the hemodynamic effects of the epidural bupivacaine-clonidine-~     fentanyl combination with those of epidural bupivacaine- clonidine- meperdine. The secondary~     aim of this study was to determine the analgesic efficacy of bupivacaine-clonidine- fentanyl~     combination in comparison to bupivacaine- clonidine- meperdine combination.~   "
109938|NCT02128438|"~     In general , the diagnosis of back pain can be broken into three major categories: Mechanical~     ( Osteoarthritis , Spinal stenosis , Spondylolisthesis) ; Non- mechanical ( Tumor , Infection~     , Inflammatory arthritis ) and Miscellaneous (Osteoporosis , Psychosomatic disorders ,~     neuropathic joints , visceral diseases ). Although 98% of LBP may be caused by mechanical~     factors, it is the other 2% caused by malignancy, infection, visceral diseases and other red~     herrings that must be considered most seriously.~      The investigators have observed in their practice that lateral pressure on 5th lumbar~     vertebra sometimes gives rise to cervicothoracic pain and central PA pressure over~     cervicothoracic spines reproduce original low back and leg pain. So the question arises~     whether Cervico-thoracic dysfunction is associated with low back pain with or without~     radiation to lower extremities?~   "
109939|NCT02128425|"~     The purpose of the study is to evaluate if the exposure to all the three active cytotoxic~     agents (FOLFOXIRI regimen) is superior in terms of progression-free survival to conventional~     chemotherapy with the FOLFOX regimen as first-line treatment of chemo-naive metastatic~     colorectal cancer patients.~      A second primary aim is to evaluate the response rate, safety and tolerability of the~     chemotherapy of FOLFOXIRI regimen in this patient population.~      Patients will be randomized to two therapy groups:~      Experimental arm A: Chemotherapy with FOLFOXIRI Standard arm B: Chemotherapy with FOLFOX~   "
109940|NCT02128412|"~     Stent placement is now widely accepted to improve the results of angioplasty (an operation to~     widen the blood vessel) and decreasing the need for further surgery. Despite their worldwide~     acceptance, stent usage is still limited by renarrowing which occurs within the stent~     (restenosis) in some patients within the first six months. In addition there still exists a~     small risk of heart attacks soon after the stent is placed.~      The purpose of this study is to test the safety and tolerability of trying to place the~     stents using a different strategy of using low pressure oversized balloon inflations as~     opposed to the usual high pressure balloon inflations. This may reduce injury to the artery~     and reduce the chance of renarrowing of the stent. In order to ensure this is a safe and~     effective way of performing the procedure the investigators intend to use an Intravascular~     ultrasound (IVUS) catheter to look from inside the artery at the stents. IVUS has proven to~     be the best way of ensuring optimal stent placement.~      Primary hypothesis: Stents will be equally well expanded and apposed using a strategy of~     oversized stenting at normal inflation pressures ( < 10 atmospheres ) as compared to high~     pressure inflation (≥14 atmospheres) as guided by intravascular ultrasound imaging.~      Secondary Hypothesis: There will be no difference in acute clinical endpoints (death,~     myocardial infarction, urgent revascularisation or stent thrombosis) using a strategy of~     oversized stenting at normal inflation pressure as compared to high pressure inflation.~      Tertiary Hypothesis: If the above is shown to be true the investigators would hope to expand~     the study in order to reveal a decrease in stent restenosis using a strategy of lower~     pressure balloon inflations. The investigators will assess the deployment characteristics of~     drug eluting versus bare metal stents~   "
109941|NCT02128399|"~     Antimicrobial exposure is known to reduce the selection for various drug-resistant organisms.~     Numerous studies have demonstrated the association between antimicrobial use and MDR bacteria~     detection. However, to the investigators knowledge, there is few data to support the concept~     that reducing antibiotic use actually leads to improvements in antibiotic susceptibilities.~     Moreover, antimicrobial stewardship was demonstrated to reduce MDRO and was strongly~     recommended in clinics. As the investigators know, antimicrobial overuse, which occurs~     commonly in China, induces a severe antibacterial resistance. China's Ministry of Health~     (MOH) has established a policy about the antimicrobial stewardship. To date, the~     investigators do not have published documentation the effects of this policy on~     multidrug-resistant organism (MDRO) in critically ill patients.~   "
109942|NCT02128386|"~     The purpose of this study is to estimate the proportion of patients with true resistance~     among patients referred to the Medical Outpatient Department of the Charité -~     Universitätsmedizin Berlin with the diagnosis resistant hypertension. Moreover, data on~     medication adherence will be collected based on therapeutic drug monitoring and on the~     answers to validated questionnaires. Finally, efficacy, safety and costs of renal sympathetic~     denervation will be compared to an intensified drug treatment in an exploratory way.~   "
109943|NCT02128373|"~     This pilot clinical trial studies the feasibility and effectiveness of a new computer-based~     communication intervention in supporting distance caregivers of patients with advanced lung~     or brain cancer. Unlike local caregivers, distance caregivers often receive little, if any,~     professional support and have limited communication with the oncology team. Using a~     computer-based communication intervention to allow distance caregivers the opportunity to~     participate in a physician visit, have questions and concerns addressed, and meet members of~     the oncology team may help reduce stress.~   "
109944|NCT02128360|"~     The purpose of this study is to determine whether minimal ovarian stimulation for in vitro~     fertilization is superior to high dose stimulation. Number of mature eggs, number of embryos~     as well as pregnancy rates will be compared.~   "
109945|NCT02128347|"~     Home dialysis has many potential benefits compared to in-center hemodialysis including~     improved quality of life, reduced hospital admission and reduced cost. However, some patients~     perceive that home modalities are associated with increased isolation from the healthcare~     system, substandard care or higher risk of catastrophic events. Providing better support for~     home dialysis patients may enhance their ability to maintain at home, improve their health~     outcomes, increase quality of life and improve satisfaction with care. In other chronic~     disease populations a secure, online communication portal between physicians and patients has~     proven useful in enhancing care for patients. Thus far, the utility of an online portal~     communication system has not been tested in a cohort of home dialysis patients. The~     investigators hypothesize that this novel form of communication will improve care and~     outcomes for home dialysis patients. Therefore, in a cohort of home dialysis patients, the~     purposes of this study are as follows: 1) Does an online patient-portal improve patient~     satisfaction with home dialysis care? 2) Does an online patient-portal improve quality of~     life? 3) Does an online patient-portal reduce hospitalization and health service utilization?~   "
109946|NCT02128334|"~     Eligard is a 6-month depot injection formulation that combines the active ingredient~     leuprorelin acetate (LA) with a biodegradable polymer matrix (Atrigel® delivery system). The~     6-month (45 mg) formulation was approved for the Russian market in 2009. It has been shown to~     reduce testosterone and prostate-specific antigen (PSA) levels and to be well tolerated in~     several clinical trials. However, clinical trials are limited by strict patient inclusion and~     exclusion criteria. Therefore, the current non-interventional study aimed at investigating~     whether the efficacy and tolerability of the 6-month LA depot formulation could also be~     confirmed in a broad and heterogeneous patient population encountered in daily clinical~     practice in the Russian Federation.~      This study will evaluate total serum PSA and testosterone levels, Quality of Life (QoL) of~     patients, demographic patient data, diagnosis and diagnostic findings in patients. It will~     provide analysis in different subgroups of patients depending on previous hormonal treatment~     and anamnesis of disease.~   "
109947|NCT02128321|"~     The purpose of this study is to assess the effect of multiple doses of isavuconazole on the~     pharmacokinetics of Repaglinide and possible metabolites after single dose administration. In~     addition, this study will assess the effect of multiple doses of isavuconazole on the~     pharmacokinetics of caffeine and possible metabolites after single dose administration.~     Safety and tolerability of isavuconazole alone and in combination with Repaglinide or in~     combination with caffeine will be assessed.~   "
109948|NCT02128308|"~     This study aims to investigate the pharmacokinetic characteristics of second-line~     anti-tuberculosis agents after oral/intramuscular administration in healthy male volunteers.~   "
109980|NCT02127892|"~     This is a pilot clinical trial of hematopoietic stem cell transplantation for patients with a~     diagnosis of Severe Combined Immune Deficiency (SCID) who do not have an HLA-matched sibling~     donor. The stem cells will be derived from a 1) matched unrelated donor (MUD), 2) unrelated~     cord blood donor, or 3) a haplo-identical (parental) donor (in descending order of~     preference).Patients will receive a novel conditioning regimen with Busulfan, Fludarabine and~     Anti-thymocyte globulin (ATG) followed by an unrelated donor hematopoietic stem cell~     transplant (HSCT) with T-cell depletion using the CliniMACS device.~   "
109949|NCT02128295|"~     This is a randomised trial of two modern single electric breast pumps allocated to mothers~     who are exclusively breast feeding their healthy term infants. Mothers will be recruited when~     their infants are around a month old, they will be randomised either to use one of two state~     of the art modern single electric breast pumps or to act as controls with no breast pump (but~     will receive a baby care voucher of similar value). If allocated to a breast pump, mothers~     will be asked to take part in a physiological study when their babies are 6 weeks old. In~     this test the mothers will be asked to express breast milk for 10 minutes on each breast. The~     primary hypothesis is that the total weight of milk produced in a 20 minute period and the~     weight of milk produced at 1 minute intervals at age 6 weeks will be greater for mothers~     using one of the pumps. A small sample of breast milk (~5ml) will be collected for analysis,~     the remaining expressed milk will returned to the mother.~      Each month between the age of 3 and 6 months, all the mothers will be asked to complete~     online questionnaires about their breast-feeding and the use of their breast pumps (if they~     have one). At the end of the six months the mothers will be given a small voucher for a~     child-care store as a way of saying 'thank-you' for the inconvenience caused.~   "
109950|NCT02128282|"~     This study considers the safety and tolerability of increasing doses of CX-4945 in~     combination with gemcitabine plus cisplatin to determine the maximum tolerated dose (MTD),~     followed by a randomized study that compares antitumor activity in cholangiocarcinoma~     patients receiving the standard of care gemcitabine plus cisplatin versus CX-4945 at the~     combination MTD with gemcitabine plus cisplatin.~   "
109951|NCT02128269|"~     The primary purpose of this study was to evaluate the safety and tolerability of intravenous~     (IV) ALXN1007 in persistently antiphospholipid (aPL)-positive patients with at least 1 of the~     following non-criteria manifestations of APS: aPL-nephropathy, skin ulcers and/or~     thrombocytopenia.~   "
109952|NCT02128256|"~     The surgical management of long bone infections is often challenging. Adequate surgical~     debridement decreases the bacterial load, removes dead tissues, and gives a chance for the~     host immune system and antibiotics to arrest infection. Adequate debridement may leave a~     large bony defect. An appropriate management of the dead space is essential to arrest the~     disease, and for maintenance of the bone's integrity. The current strategy includes the use~     of antibiotic-loaded bone cement that can be used to sterilize and temporarily maintain the~     dead space. The cement are usually removed after 2 to 4 weeks and replaced with a cancellous~     graft harvested from the hip of the patient.~      CERAMENT™| G is a CE-marked resorbable ceramic bone graft substitute composed by calcium~     sulfate and calcium hydroxyapatite, intended to fill gaps and voids in the skeleton system~     and to promote bone healing. The antibiotic gentamicin is included in the ceramic to prevent~     colonization of gentamicin-sensible microorganisms in order to protect bone healing.~      The aim of this study is to investigate the device absorption and bone in-growth of~     CERAMENT™| G in a surgically revised bone infection. In addition, bone healing and infection~     non-recurrence will be evaluated during 12 months of follow-up. The investigators expect a~     treatment success of >90 % and that a similar bone healing will be obtained as with a~     standard two-stage surgical procedure. In addition, the investigators believe that the use of~     CERAMENT™| G will be of advantage for the patient as bone healing will be achieved with a~     one-stage surgical procedure (in combination with antibiotic therapy), instead of a two-stage~     procedure, thus decreasing potential surgery-related complications.~   "
109953|NCT02128243|"~     The aim is to assess the relative efficacy of S-1 de-escalation therapy vs. continuation of~     chemotherapy after induction therapy in patients with metastatic esophagogastric cancer in~     terms of overall survival.~   "
109954|NCT02128230|"~     The purpose of this study is to improve the clinical outcomes of research subjects with~     high-risk multiple myeloma in the context of the immediately preceding Total therapy 5 trial~     2008-02 and Total therapy 3 trials 2003-33 and 2006-66.~   "
109955|NCT02128217|"~     Early identification of acute HCV infection is essential to prevent chronic infections and~     the long-term liver disease complications that may occur. Early identification and treatment~     of HCV during the acute phase can result in significantly higher response rates with shorter~     durations of therapy.~      Pegylated-interferon alfa (PEG-IFN) was the typical treatment for HCV infection. Participants~     subcutaneously inject PEG-IFN where the average duration of treatment was approximately 20~     weeks. With the advancement of direct-acting antivirals (DAAs), it was possible to see if a~     new DAA might be non-inferior compared to (PEG-IFN).~      The study was designed to see if a fixed-dose combination tablet can replace the old HCV~     treatments by being more effective, safer and better tolerated in HIV-infected participants~     with new HCV infection. The study was a Phase I, open-label, two cohort clinical trial, in~     which 44 acutely HCV-infected HIV-1 positive participants were enrolled. Participants in each~     cohort were evaluated in two steps: on treatment (Step 1) and follow-up after discontinuing~     study treatment (Step 2). The cohorts were enrolled sequentially. Participants in Cohort 1~     were enrolled and administered oral Sofosbuvir (SOF) in combination with weight-based~     ribavirin (RBV). Participants in Cohort 2 were enrolled and administered an oral fixed dose~     combination of Ledipasvir/Sofosbuvir (LDV/SOF).~   "
109956|NCT02128204|"~     The study is a double-blind, randomized, within-subject controlled, 2-armed, single-centre~     study sponsored by SciVision Biotech Inc. and approved by Yuan's General Hospital~     Institutional Review Board. The aim of this post-marketing study is to evaluate the safety~     and efficacy of HYADERMIS LA facial dermal implant for the improvement of nasolabial folds.~      The study was estimated to be held half to one year including a 0-2 weeks screening period, a~     day of treatment, and follow-up at week 1 and 2. Patient informed consent forms will be~     obtained before volunteers enter screening period. If the volunteers meet all the criteria,~     they will be given a number to replace their name in the study. The participants will be~     randomised assigned to receive experiment treatment, HYADERMIS LA, in one side of nasolabial~     folds and control treatment, Hya-Dermis, in the other side of the face. The safety assessment~     evaluated any recorded adverse events following the device treatments either by blinded~     evaluator or subjects. The effectiveness of the treatment devices will be assessed by using~     photographic assessment, nasoalabial folds severity scale, global aesthetic improvement~     scale, and pain visual analog scale.~   "
109957|NCT02128191|"~     The purpose of this study is to evaluate the efficacy and safety of no treatment compared~     with ibuprofen treatment for patent ductus arteriosus in preterm infants. The study~     hypothesis is that no treatment is not inferior to oral ibuprofen treatment in preterm~     infants. (non-inferiority study)~   "
109960|NCT02128152|"~     The purpose of this study is to assess the safety and effectiveness of the Ekso robotic~     exoskeleton in persons affected by a severe stroke.~        -  Primary Objectives:~             -  To determine if a structured high-dosage exoskeleton training program (EXTP)~               results in clinically significant gains in walking recovery in individuals affected~               by severe stroke.~             -  To determine whether timing of EXTP delivery (i.e., sub-acute vs. chronic) and~               severity (non-ambulators vs. limited house-hold ambulators) affects the improvement~               in gait speed and overall function following the EXTP training protocol.~             -  To determine whether maintenance or further improvement in gait speed can be~               achieved by an intensive follow-up program of either a traditional rehabilitation~               program (TRP) or extended EXTP.~        -  Secondary Objectives:~             -  To determine the effect on functional walking endurance as assessed by the 6 minute~               walk test and 10 meter walk test, in high-dosage exoskeleton training program~               (EXTP) vs. traditional rehabilitation program (TRP) carried in an outpatient~               setting for post stroke individuals.~             -  To determine the effect on functional balance, as assessed by the Berg Balance~               Scale, Functional Gait Assessment and Five times sit to stand measure as assessed~               by the 6 minute walk test, in high-dosage exoskeleton training program (EXTP) vs.~               traditional rehabilitation program (TRP) carried in an outpatient setting for post~               stroke individuals.~             -  To determine the effect on stroke recovery, as assessed by the step counter of task~               specific training in high-dosage exoskeleton training program (EXTP) vs.~               traditional rehabilitation program (TRP) carried in an outpatient setting~   "
109961|NCT02128139|"~     Introduction. Comprehensive data on infective endocarditis in developing countries are~     scarce.~      Objectives: Description of the characteristics (clinical and microbiological) and assessment~     of the outcomes of infective endocarditis in low-income countries.~      Methods : Prospective, Observational, Multicentre study. Inclusion criteria: patients aged~     over 1 year fulfilling the modified Duke criteria for infective endocarditis.~      Exclusion criteria: patient included during a previous infective endocarditis episode.~      Outcomes measures: Mortality at 6 months follow-up; mortality at 1 month follow-up; access to~     antibiotic treatment (modalities and duration), hospital length of stay and reason for~     discharge, and cardiac surgery when indicated.~      Duration: One year (June 2014- June 2015)~   "
109962|NCT02128126|"~     The purpose of the study is to assess the safety, tolerability and the HPV-specific immune~     responses of different doses of ISA101 vaccine with or without pegylated IFNα as combination~     therapy with carboplatin and paclitaxel.~      To qualitatively assess the safety profile and the HPV-specific immune responses of ISA101b~     vaccine compared to ISA101 at the same dose levels.~      To assess the safety and the HPV-specific immune responses of ISA101b vaccine with~     carboplatin, paclitaxel with or without bevacizumab.~   "
109963|NCT02128113|"~     This study assesses the efficacy and safety of two concentrations of omaveloxolone (RTA 408)~     ophthalmic suspension for the prevention of corneal endothelial cell loss following cataract~     surgery.~   "
109964|NCT02128100|"~     This study wants to find out how safe and effective the use of Folfirinox combined with~     Stereotactic Body Radiation Therapy )(SBRT) is for the treatment of pancreatic cancer.~   "
109965|NCT02128087|"~     In this project the investigators develop and test a short message service (SMS) intervention~     based on the Information Motivation and Behavior skills (IMB) model. Reminding Adolescents To~     Adhere (RATA) prompts youths at two clinics in Uganda to take their medications and offers~     social support via weekly text messages. The investigators propose to adapt their previous~     successful SMS-intervention to the specific needs of youths and to evaluate the relative~     effectiveness of one-way versus two-way text messages (where two-way messages allow youths to~     respond to messages and we hypothesize that this may increase perceived social support that~     may be important for youth populations). We will also test the effectiveness of SMS messages~     over the longer-term (2 years), for which currently no information is available.~   "
109966|NCT02128074|"~     The objective of this pilot study is to evaluate the efficacy and safety of KRX-0502,~     administered without food, in treating iron deficiency anemia in subjects with stage 3 to 5~     non-dialysis dependent chronic kidney disease (NDD-CKD).~   "
109967|NCT02128061|"~     The purpose of this study is to compare the efficacy of R2-miniCHOP (Sub-cutaneous~     Rituximab-miniCHOP + lenalidomide) and R-miniCHOP (Sub-cutaneous Rituximab-miniCHOP) in~     patients aged 80 years old or more with not previously treated cluster of differentiation~     antigen 20 positive (CD20+) diffuse large B-cell lymphoma as measured by the overall survival~     (OS).The SENIOR trial will evaluate the tolerance and efficacy of the combination of the~     R2-miniCHOP regimen and compare this experimental arm to the standard R-miniCHOP regimen.The~     statistical plan is based on the hypothesis of an increase by 15% of the 2y-OS in favor of~     the experimental arm, as compared to the reference arm (R-miniCHOP).~   "
109968|NCT02128048|"~     Tobacco smoke is probably the single most significant source of toxic chemicals that humans~     are exposed to. Smoking is associated with a variety of pathological conditions such as~     cardiovascular and pulmonary diseases. In addition to the known harmful effects of cigarette~     smoking, several epidemiological studies identified tobacco use as a risk factor for~     sarcopenia, the loss of skeletal muscle mass and strength with advancing age. Previous~     studies examined skeletal muscles of smokers in comparison with muscles of non-smokers and~     found structural and metabolic damage in muscles of smokers.~      Quitting of smoking is known to be associated with weight gain. A previous study examined the~     effects of smoking cessation on body composition of post-menopausal women using dual-energy~     x-ray absorptiometry (DEXA). It was found that women who successfully quit smoking for a~     period of 16 months have significantly increased their body weight, fat mass, muscle mass and~     functional muscle mass in comparison with non-quitters women. For the first time, it was~     shown that smoking cessation is associated with an increase of functional muscle mass. Yet,~     the effects of quitting of smoking on muscle mass and muscle functional capabilities of~     younger subjects remain unclear. Therefore, we aim to investigate the effects of smoking~     cessation on muscle mass, muscle function and strength in heavy smoker's subjects. Our~     findings may shed light on the beneficial effects of smoking cessation regarding the status~     and function of skeletal muscle in heavy smokers and as a possible strategy to prevent or~     delay the progression of sarcopenia.~      Research hypothesis: Smoking cessation among adult heavy smokers will lead to increase in~     skeletal muscle mass and improvement of muscle function and strength compared with continued~     smokers.~   "
109969|NCT02128035|"~     RADIATION PROTECT is a randomized, controlled trial of patients undergoing coronary~     angiography or PCI with or without a pelvic lead shield. Interventional cardiologists who~     will perform the procedure will wear a radiation protection cap in all procedures.~      It is hypothesized that routine use of the pelvic lead shield and radiation protection cap~     during these procedures will reduce the amount of radiation in which the interventional~     cardiologists get exposed.~   "
110012|NCT02127476|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of~     KHK6640, given as a single dose and as multiple doses in patients with Prodromal Alzheimer's~     Disease (AD) or Mild to Moderate AD.~   "
112741|NCT02091752|"~     The aim of the study is to assess the efficacy and safety of restarting ruxolitinib after~     treatment interruption due to loss of response and/or adverse events.~   "
109970|NCT02128022|"~     Ischaemic heart disease is the most common cause of death in the UK. Glucagon-like peptide-1~     (GLP-1) has been demonstrated to protect the heart when it is deprived of blood supply~     (ischaemia). The mechanism for this protection is not clear. Similar protection occurs with~     ischaemic conditioning of the heart, which is dependent on potassium channel opening.~      The investigators intend to establish whether GLP-1 mediated protection shares a similar~     mechanistic pathway. In order to do this the investigators will measures pressure--volume~     loops generated in the main pumping chamber of the heart at the time of a percutaneous~     coronary intervention (stenting). Patients will be allocated to GLP-1 alone, GLP-1 with~     glibenclamide (a potassium channel blocking medication approved for human use), saline~     control or glibenclamide alone.~      The investigators hypothesis is that the effect of GLP-1 will be abrogated by use of~     glibenclamide.~   "
109971|NCT02128009|"~     The miRNA plays an important regulation role in gene expression, and also closely related to~     bone metabolism. Previous research found that postmenopausal osteoporosis with kidney Yin~     deficiency syndrome (POP) is associated with CLCF1 gene. This project proposed by~     bioinformatics prediction CLCF1 targeted regulation of miRNAs, and use the 3 'UTR dual~     luciferase report system for target validation, aimed at the miRNA levels to explore~     postmenopausal osteoporosis molecular mechanism with kidney Yin deficiency syndrome.~   "
109972|NCT02127996|"~     Angina is caused by narrowings or blockages within coronary arteries. Coronary angioplasty~     and stenting is performed for people with angina to improve the blood supply to the heart by~     placing metal tubes within the artery using balloon inflation. The procedure risks small but~     significant damage to the heart muscle downstream of the balloon.~      Glucagon like peptide 1 (GLP 1) is a naturally occurring hormone secreted by cells in the gut~     in response to food. It acts by stimulating the release of insulin. In the heart it acts to~     increase glucose uptake into cardiac muscle. GLP−1 can protect the heart and improve heart~     muscle performance in people with coronary artery disease in physiological studies. This~     study which assesses whether GLP−1 protects the heart during coronary angioplasty and~     stenting.~      The hypothesis is that GLP-1 given during elective coronary angioplasty and stenting will~     reduce cardiac troponin rise (a measure of heart muscle damage) compared to placebo.~   "
109973|NCT02127983|"~     The intervention consisted of training non-paid informal healthcare providers (such as~     store-keepers) in TB and HIV disease recognition, sputum specimen collection, referral to the~     public health system, and raising community awareness. Front line public health personnel and~     community leaders were sensitised to support the intervention.~   "
109974|NCT02127970|"~     To compare the efficacy of treatment with a single dose of dalbavancin 1500 mg to treatment~     with a two dose regimen of dalbavancin (1000 mg on Day 1 followed by 500 mg on Day 8) in~     patients with known or suspected Gram-positive abSSSI (acute bacterial skin and skin~     structure infections) at 48 -72 hours after initiation of treatment.~   "
109975|NCT02127957|"~     The objective of the investigators research program is to determine whether a combined~     exercise program (aerobic and resistance) improves abnormal glucose tolerance and diabetes~     control in CF patients. This program of exercises to increase strength and muscle endurance,~     exercise tolerance, will be assessed in a group of 12 CF patients with impaired glucose~     tolerance. The effect of exercise will be compared with a control group of 12 patients also~     glucose intolerant but do not participate in structured physical activity program. The~     duration of the exercise program will be 12 weeks and several measures (glucose tolerance,~     inflammatory profile, lung function, exercise capacity, muscle strength and endurance) will~     be conducted pre and post program to assess the program's impact .~   "
109976|NCT02127944|"~     IN UNEXPLAINED INFERTILITY IN WOMEN ,OVARY RESERVE IS BORDERLINE IF ASSESSED USING~     HIGH-SENSITIVE TESTS.~   "
109977|NCT02127931|"~     Current diagnostic aids used in treating ADHD are currently expensive, time intensive, and~     provide little information about accessory movements in response to a stimulus.~      Tests such as the Conners' Rating Scale require subjective responses from parents and~     teachers, making coordination difficult. The computerized Conners' Continuous Performance~     Test (CPT) provides objective data in regards to inattention and impulsive patterns of~     response. However, it does not provide data regarding accessory movements such as~     restlessness, hyperactivity, and other inappropriate movements. If the subject taking the~     exam has a reading disorder, it will impair his or her ability to respond accurately and it~     will increase response time. The T.O.V.A. is another computer based test used as a diagnostic~     aid for ADHD, which uses a microswitch to record responses. It does utilize auditory and~     visual stimuli, which removes the reading level limitation. However, it is unable to measure~     to measure accessory movements that may be contributing to reaction time and errors of~     omission and commission.~      Because of these limitations, a new company called CogCubed has created a new game based on~     the Sifteo Cube (http://www.sifteo.com) platform. These new hands-on digitized cubes are~     unique, motion-sensitive wireless blocks that contain multiple sensors that can interact with~     one another. CogCubed is providing the data for this study. The game will be played in a 30~     minute sessions by subjects aged 18 and over. Subjects recruited to play the game will be~     those with ADHD and those without, matched by gender. Those with comorbidities of~     developmental delay, mental retardation, psychosis, schizophrenia, bipolar disorder and~     substance use disorders will be excluded, as well as any physiological disability that~     affects upper limb movement and/or coordination. Informed consent will be obtained from~     participant prior to administering the game.~      The hypothesis is that by analyzing data generated from this new gaming platform named Sifteo~     for which a game was created, which uses auditory and visual stimuli and distracters, the~     investigators expect that they will be able to provide a more accurate profile of impulsivity~     and inattention. The investigators expect that inattention will have more errors of omission~     and less tilt movements than control and impulsivity will be represented as more commission~     and greater tilting movements than control.~   "
109978|NCT02127918|"~     Electrical status epilepticus in sleep (ESES) is a pattern of abnormal discharges in the~     electroencephalogram (EEG). Children who have this pattern present seizures and~     neuropsychological regression. There are no studies that systematically evaluate the response~     of abnormal discharges in the EEG, seizures and neuropsychological regression to different~     antiepileptic treatments. Therefore, treatment strategies in ESES are not based on scientific~     evidence. High-dose benzodiazepines such as diazepam (valium) have been reported to improve~     the severe EEG abnormalities of patients with ESES in the short-term. But the long-term~     response of seizures and neuropsychological regression has not been systematically studied.~     Clobazam is a benzodiazepine derivative with antiepileptic properties. The pharmacologic~     properties of clobazam make of this drug a particularly useful option in ESES: in patients~     with ESES the alpha-2 subunit of the GABA receptor is preferentially up-regulated and~     clobazam may have a higher affinity for this particular subunit, so investigators expect a~     higher effect of this drug on ESES patients than with other benzodiazepines (Loddenkemper et~     al, in preparation). The aim of our study is to objectively evaluate the response to clobazam~     treatment of neuropsychological deficits, seizures and abnormal discharges in the EEG in~     patients with ESES. Clobazam treatment is used in routine clinical practice and investigators~     will objectively quantify its effect.~      Our working hypothesis is that high-dose clobazam treatment may control the abnormal~     epileptiform discharges in the EEG in patients with ESES. The reduction in abnormal~     epileptiform discharges may lead to an improvement in neuropsychological deficits and~     seizures. The predicted improvement in seizures and neuropsychological function would lead to~     a better quality of life in these patients.~   "
109979|NCT02127905|"~     The protocol is designed for the compassionate treatment of patients with Fanconi Anemia who~     do not have an HLA-matched sibling donor. The purpose of this study is to determine the~     likelihood of engraftment in Fanconi Anemia patients using total body irradiation (TBI),~     cyclophosphamide (CY), fludarabine (FLU) and antithymocyte globulin (ATG) followed by an~     unrelated donor hematopoietic cell transplant with T-cell depletion using the CliniMACS~     device.~   "
109985|NCT02127827|"~     Insulin replacement therapy is absolutely required for patients with Type 1 diabetes. The~     insulin pump provides for continuous subcutaneous insulin infusion (CSII), which can~     approximate the insulin release patterns of the normal pancreas. Timely and accurate~     knowledge of ambient glucose levels is important for insulin dose adjustments. Typically,~     glucose values are measured volitionally, several times a day, using capillary fingerstick~     samples. In addition, glucose in the interstitial fluid can be measured automatically and~     continuously using implantable glucose oxidase-based sensors. Recent study showed that this~     continuous measurement of glucose levels allows for a fully automated closed-loop insulin~     replacement therapy which requires an algorithm that receives glucose data, calculates an~     appropriate insulin dose, and directs the pump to deliver the insulin dose.The need for~     development of a closed-loop insulin replacement system that integrates insulin delivery,~     glucose measurement, and control subsystems will present several challenges to biomedical~     engineers.~   "
109986|NCT02127814|"~     The purpose of this study is to find whether Lactobacillus reuteri prevents~     antibiotic-associated diarrhea and related Clostridium difficile infections. Subjects will be~     admitted from the University Hospitals Case Medical Center. They will be randomly assigned to~     an intervention group receiving L. reuteri or a placebo. Supplementation will occur during~     antibiotic treatment and for an additional 7 days after cessation of treatment. Data~     collection will occur at baseline, end of antibiotic use, 7 days after antibiotic cessation,~     and 21 days after antibiotic cessation. Primary data includes diarrhea instances. Secondary~     data includes severity of diarrhea, presence of C. difficile toxins, and presence of other GI~     symptoms.~   "
109987|NCT02127801|"~     The purposes of this study are to assess the efficacy, safety and tolerability of a single~     dose of REGN1908-1909 in allergic adult participants, to collect information about how much~     REGN1908-1909 is in blood over time and to collect information about how the body reacts to~     REGN1908-1909.~   "
109988|NCT02127788|"~     The purpose of this observational study is to describe the actual conditions of prescription~     of micafungin in antifungal prophylaxis in French haematological and onco-haematological~     units. The efficacy and the safety outcomes will be described.~   "
109989|NCT02127775|"~     This study will assess the bioequivalence of lesinurad tablets manufactured at two different~     sites.~   "
109990|NCT02127762|"~     By 2020, it is estimated that 3.7 million Canadians will have diabetes mellitus, with type 2~     diabetes (T2DM) accounting for more than 90% of cases. Estimates of the prevalence of~     diabetic peripheral neuropathy among adults with T2DM range from 26% to 47%. It increases~     with patient age and duration of disease and it can be as high as 60 to 70% in older cohorts.~     Diabetic peripheral neuropathy is documented in most studies as numbness, tingling, pain~     and/or objective sensory changes. Pain is an early manifestation of neuropathy and may be the~     presenting symptom of diabetes. Even the best medications and procedures rarely relieve more~     than 30% of the discomfort of chronic painful conditions. Diabetic patients continue to~     experience debilitating and disabling pain. Pain affects our ability to work, our ability to~     participate in recreational activities, our mood and our relationships. It is~     well-established that an interdisciplinary approach is key to the treatment of some types of~     chronic pain, but little research has been done on the effectiveness of interdisciplinary~     treatments for patients suffering from painful diabetic peripheral neuropathy. The~     investigators will evaluate the effectiveness of an interdisciplinary approach combining~     medical treatment and mindfulness-based stress reduction (MBSR) to reduce disability and~     improve quality of life among patients with painful diabetic peripheral neuropathy. The~     investigators will also evaluate the impact of the program on psychological distress, pain~     cognitions, and biomarkers of stress and glycemic function.~   "
109991|NCT02127749|"~     The purpose of this study is to determine whether treatment with antibiotics, which harm the~     gut flora, causes the immune system to be less effective.~   "
109992|NCT02127736|"~     The purpose of this study is to evaluate whether an Amitriptylin induced change in sleep~     patterns can be conditioned according to learning theory in healthy participants.~   "
109993|NCT02127723|"~     The most common treatments today for enhancing the shape and size of the buttocks are~     transplantation of the patient's own body fat after liposuction and insertion of permanent~     implants. Macrolane VRF30 is a gel product based on hyaluronic acid which is a transparent~     slow-flowing gel. A similar hyaluronic-acid gel from the same manufacturer, Q-Med AB, has~     been used for many years for the treatment of facial wrinkles. By injecting Macrolane gel~     into the skin, the shape of the buttocks can be altered and their volume increased.~   "
109994|NCT02127710|"~     This is an open-label, single-arm, multicentre, global, phase II study designed to evaluate~     the efficacy and safety of AZD6094 in patients with papillary renal cell carcinoma (PRCC) who~     are treatment naïve or previously treated.~      An independent central pathology review of tumour samples will be used to confirm the~     diagnosis of PRCC of all patients enrolling. However, locally available pathology results~     confirming PRCC will be allowed for timely study entry.~   "
109995|NCT02127697|"~     The study will assess efficacy, safety and tolerability of NVA237 compared to placebo in~     patients with poorly controlled asthma over 52 weeks of treatment.~   "
109996|NCT02127684|"~     The investigators would like to investigate the efficacy of more frequent treatment with~     Lucentis for subjects with persistent diabetic macular edema despite standard dosing regimen.~   "
109997|NCT02127671|"~     This study will determine whether a program where a health coach works with participants on~     heart healthy behaviors and treatment of risk factors is coordinated with primary care can~     reduce overall heart disease risk in people with serious mental illness.~   "
109998|NCT02127658|"~     In this study, the investigators intend to compare therapies (abscess surgery and hygiene~     education compared to abscess surgery and hygiene education followed by decolonization) for~     Methicillin-Resistant Staphylococcus Aureus skin and soft tissue infections (MRSA SSTI) to~     determine which is the more effective treatment. The investigators focus on patient centered~     outcomes as described by the families of MRSA infected patients. Such outcomes are likely to~     include quality of life, side effects, and school and work attendance. The hypothesis is that~     treatment with decolonization will decrease the rate of SSTI recurrence and improve overall~     patient centered outcomes. The rationale is that negative outcomes such as recurrence may be~     avoided through the use of readily available prevention strategies, but that it is important~     to determine how burdensome those prevention strategies are for patients and families.~   "
109999|NCT02127645|"~     Objective: Recent randomized and non-randomized studies suggest that neoadjuvant radiotherapy~     followed by Transanal Endoscopic Microsurgery (TEM) show comparative results to abdominal~     resection in pT2 extraperitoneal cancer. As the risk of lymphnode metastases is significant~     already for T1 invasive cancers with submucosa infiltration >1 mm it is our intention to~     investigate in both T1sm2-3 and T2 rectal adenocarcinomas the effectiveness of this combined~     treatment in a case series comparing results of this pilot study to an historical series of~     patients affected by T1-T2 rectal cancer who underwent anterior resection (AR) or total~     mesorectal excision (TME) with or without abdomino-perineal resection (APR) with no~     neoadjuvant therapy.~      If equally effective, TEM offers a further reduction in invasiveness of treatment, which~     should correspond to a lower morbidity, mortality and a better quality of life.~   "
110000|NCT02127632|"~     Endotracheal Tube (ETT) is still preferred for laparoscopic surgeries because of the fear of~     pulmonary aspiration and inadequate ventilation. Laryngeal mask Supreme (LM-S) is a single~     use device and the presence of a drain tube allows to separate the gastrointestinal and~     respiratory tracts. We planned to compare ventilation parameters and gastric distension~     scores of with LM-S vs ETT during laparoscopic gynecological surgery.~   "
110001|NCT02127619|"~     The purpose of this study was to assess the results of a Total Knee prosthesis specifically~     intended to enhance functional performance , especially in terms of physical and sports~     activity.~   "
110002|NCT02127606|"~     Extended periods of tilt table standing have been observed to improve spasticity in~     individuals with spinal cord injury (SCI). The purpose of this study is to determine the~     effect of three sessions of whole body vibration while tilt table standing on spasticity in~     individuals with a complete or incomplete SCI above the neurological level of T10.~     Participants in this study will undergo whole body vibration while standing on a tilt table~     for a total of approximately 14 minutes for a total of 3 sessions on 3 separate days.~     Spasticity monitoring will be evaluated prior to and after the intervention with the Modified~     Penn Spasm Frequency Scale, an interview to obtain the individual's perception and impression~     of the effect of whole body vibration on the performance of activities of daily living,~     quality of life, pain scale, and global impression of change.~   "
110003|NCT02127593|"~     The purpose of this study is to establish the bioequivalence of the hormones norgestimate,~     norelgestromin, and ethinyl estradiol in norgestimate/ethinyl estradiol (NGM/EE) tablets,~     formulated by wet process compared with the same hormones in NGM/EE tablets, formulated by~     dry process, in healthy women.~   "
110004|NCT02127580|"~     There is limited experience for the balloon expandable THV (transcatheter heart valve) on the~     need for predilation (ballon aortic valvuloplasty, BAV). Therefore we aim to verify results~     of a small case series published by Wendler et. al. to examine hard endpoints such as the~     incidence of cerebrovascular complications, paravalvular leakage and operative outcomes in a~     multicenter registry.~      We aim to compare the implantation of balloon expandable transcatheter heart valves with or~     without predilation with respect to procedural outcomes (VARC2).~   "
110005|NCT02127567|"~     Introduction: Inadequate reporting is a frequent cause of waste of research. For example,~     essential information for evaluating the risk of bias such as the method of randomization is~     lacking in 75% of published randomized controlled trials (RCTs), and over 30% of reports do~     not provide sufficient details to allow replication of the treatment evaluated in the trial~     in clinical practice. To overcome this issue, the CONSORT statement, an evidence-based,~     minimum set of recommendations for reporting RCTs was developed in 1996. These guidelines~     have since been updated in 2001 and more recently in 2010. In addition, extensions to the~     main CONSORT statement have been developed to give additional guidance for RCTs with specific~     designs (eg cluster), data (eg harm), and interventions (eg nonpharmacologic treatments).~     Many journals endorse the CONSORT statement. Some journals provide recommendations to authors~     to follow the CONSORT guidelines and some editors enforce the use of the CONSORT guidelines~     by requesting authors to submit a checklist in either the submission or acceptance stage.~     Nevertheless, inadequate reporting remains.~      Our objective is to evaluate the impact of the CONSORT based online writing tool on the~     completeness of reporting.~   "
110006|NCT02127554|"~     The aim of this study is to find the most agreeable and in the long term most efficient~     treatment for epistaxis.~   "
110007|NCT02127541|"~     Insulinoma: Insulinoma are rare, small insulin secreting neuroendocrine tumors. The only~     curative approach is the surgical excision. The preoperative detection remains a challenge. A~     non-invasive, highly sensitive tool in localizing the insulinomas would be appreciated in the~     preoperative work-up of these patients. To this aim Glucagon-like peptide-1 receptor (GLP-1R)~     imaging (Single Photon Emission Computer Tomography co-registered with a CT; SPECT/CT) could~     be a convenient tool. The possibly more sensitive approach of targeting GLP-1R using Positron~     emission tomography (PET/CT) methodology has not been investigated in patients so far.~   "
110008|NCT02127528|"~     this study aims to verify the adequacy of doses of antibiotics prescribed in clinical~     practice for the treatment of ventilated acquired pneumonia (VAP) in the intensive care unit~     (ICU) with the pharmacodynamic efficacy criteria considered relevant literature. The impact~     of these pharmacodynamic parameters on the clinical and microbiological VAP will be~     evaluated.~   "
110009|NCT02127515|"~     This is a randomized controlled trial in women at risk following combined prenatal screening~     for Down Syndrome. Women will be asked about their preferences between NIPT and routine~     prenatal diagnosis based on a dedicated questionnaire. Women will then be randomized between~     NIPT and standard invasive prenatal diagnosis.~   "
110010|NCT02127502|"~     The investigators seek to evaluate a new test for determining presence of infection/sepsis as~     compared to non-infection/systemic inflammatory response syndrome among critically ill~     patients within the first 24 hours of their being hospitalized in an intensive care unit~     (ICU) within the first 7 days of hospitalization. The primary purpose of the study is to~     validate SeptiCyte® Lab in this population as compared to: 1) the doctor's impression and 2)~     existing clinical parameters. The investigators also hope to assess how well a related, new~     blood test, SeptID® identifies different types of infection, as compared to cultures and~     other lab tests.~   "
110011|NCT02127489|"~     This study aimed to compare the efficiency of rectal midazolam addition after applying~     bupivacaine and caudal anesthesia on postoperative analgesia time, the need for additional~     analgesics, postoperative recovery, sedation, and to find out its adverse effects in children~     having lower abdominal surgery.~   "
110013|NCT02127463|"~     This is a Phase II/III,vehicle controlled, double masked, single center study. A single eye~     of 60 individuals with mild to moderate non-exudative Age-Related Macular Degeneration (AMD)~     will be randomly assigned to receive either topical 1% MC-1101 or a vehicle control over 2~     years. The study design will assess the efficacy, safety, and tolerability of MC-1101 for~     these patients.~      An analysis of the primary and secondary endpoints will be conducted when all subjects have~     completed Baseline, 1, 3, 6, 12,18 and 24 months.~   "
110014|NCT02127450|"~     The non-susceptibility of enterobacteriaceae isolates to carbapenem (CARBA) is an emerging~     concern with a high impact on infectious disease therapy. carbapenemase (CARBase) production~     are one of the mechanisms of resistance to CARBA. When CARBase production is suspected or~     proved, specific hygiene measures have to be applied in any hospital. Detecting CARBase in~     the routine in any laboratory is difficult. it will be useful to standardize them detection~     to control the emergence.~   "
110015|NCT02127437|"~     LIPS study (Lanreotide In Polycystic kidney disease Study) is a prospective randomized double~     blind placebo controlled study. The main objective is to prove that lanreotide, a~     somatostatin analog, is able to reduce the glomerular filtration rate decline over 3 years by~     at least 30%. Cardiovascular outcomes, blood pressure, quality of life and safety are among~     the secondary outcomes. The study, which will include 180 ADPKD patients, is scheduled to~     start in early 2014.~      An equal number of patients with chronic kidney disease stage 2 (90 patients with GFR 89 to~     60 ml/mn/1.73 m2) and chronic kidney disease stage 3 (90 patients with GFR 59 to 30~     ml/mn/1.73 m2) will be included. The primary endpoint (GFR decline) will be assessed by~     repeated measures, in the overall population as well as in the two GFR stratus.~   "
110016|NCT02127424|"~     To reduce late HIV diagnosis that remains common in France, the national health agency has~     promoted non-targeted HIV screening in health care settings, including emergency departments~     (EDs). In our previous survey, non-targeted nurse-driven HIV screening by rapid tests was~     feasible, well-accepted but identified only a few new HIV diagnoses mostly among patients at~     high-risk. Our findings, consistent with results from other international groups, suggest~     that a targeted strategy could be feasible, efficient and cost-effective with fewer tests~     required. However, the feasibility and the efficacy of this strategy remain unknown in~     France.~      The main aim of the present study is to compare the efficacy of 2 strategies: 1) the~     combination of the nurse-driven HIV targeted screening and the current practice~     (physician-directed HIV diagnostic testing) versus 2) the current practice alone.~      The strategies will be compared during 2 randomly assigned periods (cluster randomization and~     cross-over) in 8 EDs of metropolitan Paris.~      During targeted period, nurses will offer screening to all patients at EDs, aged 18-64 years~     old, identified as high-risk by a self-administered questionnaire, not know to be HIV~     positive, not being seen for post-exposure prophylaxis or unstable medical illness, and~     accepting to participate by providing an informed consent.~      In case of confirmed reactive rapid test result, a follow-up visit with an on-site infectious~     disease specialist will be arranged within the following 48 hours.~   "
110017|NCT02127411|"~     Benzodiazepines (BZD) are the most prescribed psychiatric drugs in Brazil, especially for~     women. Although it is recommended that the use of BZD is not greater than four weeks, there~     are many cases of prolonged use due to the lack of treatment options for dealing with~     complaints of insomnia. Given this, the aim of this project is to evaluate the program~     Mindfulness-Based Relapse Prevention (MBRP) for adult women with chronic use of~     benzodiazepine (BZD) to induce sleep. Specifically aims to evaluate if the MBRP program, can~     reduce the pattern of use and level of dependence of chronic users of BZD under gradual~     reduction (tapering) or cessation of the use of BZD. This study will be conducted at the Drug~     Dependency Unit (UDED) of the Department of Psychobiology of Federal University of São Paulo.~     The study will count with two groups: intervention group (IG) and control group (CG) (that~     will stay in the waitlist until the eighth month . The sample will comprise 100 women with~     chronic use of BZD as hypnotics, 50 will be randomized in the IG condition and 50 in the CG~     condition. Changes will be evaluated on several variables such as cessation and dependence of~     BZD, quality of life, sleep, anxiety, depression and sexual satisfaction before and after the~     intervention in both groups. The data will be submitted to descriptive and inferential~     bivariate and multivariate statistic analyzes. It is hoped that this study create subsidies~     for the development of complementary interventions for the management of withdrawal symptoms~     in chronic users of BZD.~   "
110018|NCT02127398|"~     It has been shown that restoration of the normal makeup of the bowel bacterial population is~     the most effective way to treat recurrent colitis due to Clostridium difficile. Restoration~     of the normal bowel bacterial population is best done by transplanting stool from a healthy~     donor. The investigators wish to transplant stool from healthy donors to treat recurrent C.~     difficile colitis by incorporating the stool into capsules that are administered by the oral~     route.~   "
110019|NCT02127385|"~     Intra Uterine Growth Restriction is associated with increased oxidative stress. Haptoglobin~     (Hp) is an abundant plasma glycoprotein produced in the liver. The function of Hp is as anti~     oxidant agent, it binds free hemoglobin (Hb) released from red blood cells to decrease~     oxidative tissue damage. There are 3 differenet genotype of haptoglobin Hp 1-1 Hp 1-2 and Hp~     2-2 with different anti oxidant properties and different prevalence ( Hp 1-1, Hp 1-2 and Hp~     2-2approximately 16%, 48% and 36% respectively) . we hypotheise that IUGR will be more common~     and severe in the Hp 2-2 genotype with the less anti oxidant properties.~   "
110020|NCT02127372|"~     This is a Phase 1/Phase 2 study of STI571 combined with docetaxel and cisplatin for treatment~     of patients with recurrent and metastatic Non-Small Cell Lung Cancer (NSCLC).~      This research study has 2 parts to it. The first part (Phase 1) is called a dose-escalation.~     Not all subjects enrolled into this phase of the study will receive the same dose. The~     purpose of the dose-escalation is to determine the highest safe dose of STI571 that can be~     used in combination with docetaxel and cisplatin. That dose will be used in Phase 2.~   "
110069|NCT02126735|"~     CD36, a protein that facilitates tissue uptake of fat, as a common link between blood fat~     concentrations and metabolic disease states such as diabetes mellitus. Genetic variants in~     the CD36 gene are more common in African Americans compared to Whites and it may confer~     protection against metabolic diseases by altering the amount of fat in the blood.~      The purpose of this study is to compare the levels of fat in the blood and to assess~     endothelial dysfunction among carriers versus non-carriers of the coding SNP, rs3211938 of~     the CD36 gene after a high fat meal challenge~   "
110021|NCT02127359|"~     Cancers occur when the molecules that control normal cell growth (genes and proteins) are~     altered. Changes in the tumor genes and in the genes of normal cells are called~     alterations. Many of these alterations can be detected by directly examining cancer cells~     in a tumor or circulating in blood. Several alterations that occur repeatedly in certain~     types of cancers have already been identified. These discoveries ahve led to the development~     of new drugs that target those alterations. More remain to be discovered.~      Some of the alterations are found in genes. Genes are composed of DNA letters, which~     contain the instructions that tell the cells in our bodies how to grow and work. Genes make~     proteins which actually carry out the instructions in our cells.~      We would like to use your DNA to look for alterations in the genes in cancer cells and blood~     cells using a technology called sequencing. Gene sequencing is a way of reading the DNA to~     identify errors in genes that may contribute to the behavior of cells. Some changes in genes~     occur only in cancer cells. Others occur in normal cels as well, in the genes that may have~     been passed from parent to child. This research study will examine both kinds of genes.~      The purpose of this research study is to perform gene sequencing (gene tests) on your cancer~     cells (obtained from biopsies or surgery) and normal tissues (usually blood). The results of~     the gene tests will be used to try to develop better ways to treat and prevent cancers. We~     will also study better ways to communicate the results of these complex gene tests to you and~     your doctors, and to help you and your doctors use this information to choose the best paths~     for treatment. As part of this work, we may also learn things about the genes in your normal~     cells; some of that information will also be shared wtih you and your doctors if you so~     choose.~      Importantly, this study will use tissue specimens that have already been collected and stored~     in the pathology department as part of your clinical care or as part of other research~     studies you may be participating in. In this study, gene tests will be performed on material~     only after the necessary clinical tests have been performed. In general, no additional~     invasive procedures will be required.~   "
110022|NCT02127346|"~     Objective: The objective was to evaluate whether serum vitamin D and calcium concentrations~     are associated with chronic periodontitis in Syrian men Methods: This study designed as~     Matched Case-Control Study.200 males will be enrolled in this study and will be divided~     into two groups. First group consist of 100 patients suffering from chronic periodontitis and~     no systemic diseases. Second group consist of 100 healthy volunteers. Serum vitamin D and~     calcium concentrations will be tested. Periodontal indexes include probing depth (PD),~     clinical attachment level (CAL), and bleeding on probing (BOP) will be taken. Data will be~     collected and analyzed.~   "
110023|NCT02127333|"~     Hypoxemia may contribute increased morbidity and mortality in chronic obstructive pulmonary~     disease (COPD) patients. We aim to characterize the role of acute and chronic hypoxemia for~     vascular function. For this purpose we measure capillary oxygen concentration and vascular.~      Vascular function is assessed by flow-mediated dilation oft he brachial artery, forearm blood~     flow and laser doppler perfusion imaging.~      We hypothesize that hypoxemia leads to impaired vascular function.~   "
110024|NCT02127320|"~     The purpose of this study is to investigate the pharmacokinetic drug interactions between~     Rosuvastatin and Ezetimibe in Healthy Male Subjects~   "
110025|NCT02127307|"~     This aim of the study is to investigate the prognostic usefulness of AdreView™ imaging to~     identify those subjects with New York Heart Association (NYHA) Class II or III HF who will~     die during 60 months of follow-up from the date of administration of AdreView™ in prior~     studies MBG311, MBG312, or MBG312C (hereafter included in MBG312).~   "
110026|NCT02127294|"~     The purpose of the study is to evaluate effectiveness and safety of transcatheter patent~     foramen ovale closure for migraine.~   "
110027|NCT02127281|"~     The purpose of this study is to determine the efficacy of a negative pressure wound therapy~     (NPWT) system after revision total knee and hip arthroplasty in patients at high risk for~     infection. It is hypothesized that the use of NPWT system (i.e., Prevena) in high risk~     patients prevents wound complications and decreases reoperation rates.~   "
110028|NCT02127268|"~     Cancer-related fatigue (CRF) is a distressing, persistent, subjective sense of physical,~     emotional, and/or cognitive tiredness or exhaustion related to cancer or cancer treatment~     that is not proportion to recent activity and interferes with usual functioning. Compared~     with general fatigue, CRF have the characteristics of long duration and generally cannot~     alleviate by rest or sleep, serious impact on the patient's work, study, entertainment and~     family life, and thus greatly affect the recovery, self-care ability and life quality of~     patients. Many dates showed that 70%~100% of cancer patients experienced cancer-related~     fatigue.For cancer-related fatigue there is no good treatment and intervention, in recent~     years, many clinical trials are carried out; central nervous stimulant, such as~     methylphenidate; acupuncture, aerobic exercise. All those measures may have certain~     therapeutic effect for CRF, but don't have exact evidences from massive RCT to confirm.~      Thymosin-α1 (T-α1), a synthetic 28-amino acid peptide with multiple biological activities~     primarily directed towards immune response enhancement, this drug is used for the treatment~     of HBV and hepatitis C virus (HCV) infections, and being developed for the treatment of~     non-small cell lung cancer (NSCLC), hepatocellular carcinoma, AIDS and malignant melanoma.~     T-α1 is able to potentiate the action of cytokines and also reduce the hematological toxicity~     of cytotoxic drug therapy, such as cyclophosphamide, 5-fluorouracil, dacarbazine.~      In this studies, we want to demonstrated that the effectiveness of Thymosin-α1 for~     cancer-related fatigue in cancer patients who undergo chemotherapy.~   "
110029|NCT02127255|"~     This is a randomized, controlled cross-over trial. The hypothesis of this study is that the~     differences in manual acupuncture manipulation can impact clinical effect though the~     acupuncturists follow the same needling regimen. In this study, acupuncturist 1 (clinical~     experience >15 years) and acupuncturist 2 (<5 years) will give treatments to cancer patients~     receiving cisplatin chemotherapy (n=36) for at least two continuous cycles, once per day, 5~     days per cycle. Acupuncturist 1 determines all the treatment regimens (selection of acupoints~     and methods of needling manipulation, needle retention time). Randomly, half of the patients~     will receive treatments from acupuncturist 1 in the first treatment cycle and from~     acupuncturist 2 in the second cycle; while the other half will be treated in other way round.~     There is a washout period (21 days) between two cycles. The needling manipulation of two~     acupuncturists will be measured objectively during treatments. The clinical effect will be~     measured by the control of vomiting and nausea during and after chemotherapy treatments.~   "
110054|NCT02126930|"~     The main objective of this study is to evaluate the impact of a pharmaceutical consultation~     at the time of hospital discharge on the adherence of patients ; non-adherence is determined~     by the following criteria:~      As concerns prescribed anti-infectious treatments, at least one of the following 4 criteria~     is true:~        1. . the patient did not go and get his/her treatment at the pharmacy;~        2. . the number of treatment units dispensed by the pharmacy is < the number of treatment~          units prescribed;~        3. . the patient stopped taking a treatment before the recommended time, or continued~          taking a treatment after the recommended time;~        4. . the number of treatment units taken by the patient (self-declaration) is < or > to the~          number of units prescribed.~   "
110030|NCT02127242|"~     Objective:the purpose of this study is to investigate the~     efficacy,feasibility,reliability,and safety of laparoscope combined air-pressure ballistic~     lithotripsy in the treatment of patients with bile duct stones.~      Methods:We are going to select 60 patients diagnosed with hepatolithiasis who carry on the~     treatment in our hospital from April 2014 to April 2015.According to the unified inclusion~     and exclusion criteria,the patients are divided into the experimental group and the control~     group.The experimental group use the treatment of laparoscope combine with air-pressure~     ballistic lithotripsy to treat hepatolithiasis,while the control group treat the patients~     with hepatolithiasis with the method of lobectomy and segmental resection of~     liver.Contrastive analyzed two group of patients' clinical care effects.~      Research hypothesis:according to compare two groups' duration of surgery,blood~     loss,postoperative complication rate,hospital stay,the stone clearance rate,,the residual~     stone rate,reoperation rate etc.We suppose that the clinical results of the experimental~     group are superior to the control group,difference is statistically significant(P<0.05).So we~     can draw the conclusion that the method of laparoscope combined air-pressure ballistic~     lithotripsy is useful in treatment of patients with hepatolithiasis.~   "
110031|NCT02127229|"~     The purpose of the study is to determine if endoscopist notification of accessory cost~     results in altered resource utilization related to the total cost and number of accessories~     used in ERCP.~      This study will be a prospective cost--analysis study. Only chart review of PHI removed~     records will be used. The only intervention used is that endoscopists will be made aware of~     the cost of accessories used in the second phase of the study following each ERCP.~      The investigators are in an era of increased medical cost consciousness. Medical education~     and post--graduate education incorporates cost savings and appropriate diagnostic test~     selection based on expense as one aspects of the decision process. This era now focuses on~     what is best for the patient with the understanding that the cost to the patient and cost to~     the overall health care system matters. Not only is this apart of postgraduate training but~     now being implemented as part of Medicare reimbursement to provide low cost and high quality~     care. Incidence of pancreatic and biliary disease is increasing. ERCP is a vital tool for~     therapeutic intervention. The costs of these procedures, to both patients and hospitals, have~     caused some to question the amount of accessories used as well as the poor reimbursement~     provided by Medicare and insurers. Studies have indicated that hospitals actually lose money~     with each ERCP used and their use is being limited many times to tertiary care centers.~   "
110032|NCT02127216|"~     In 2010, 25.8 million people in the US, or 8.3% of the population were reported to have~     diabetes. Type 2 diabetes mellitus (T2DM) is especially prevalent among older adults: 26.9%~     of people 65 years or older have diabetes with 50% being pre-diabetic. Diabetes is the~     leading cause of blindness, kidney disease and lower-limb amputation among older adults, and~     is also a major risk factor for cardiovascular disease.~      Fortunately, diabetes and its related complications are very amenable to lifestyle changes.~     Engagement with healthcare providers can significantly affects behavior and disease~     management of practices of individuals as does social engagement. The use of mobile~     technology and better engagement with providers and peer support networks may support~     diabetes self-care management. Individual patient personality attributes may affect the~     success of technology interventions.~      In this study, the investigators propose to design and test a motivation psychology-based~     smart engagement system (MOSES), which is a software application on a digital tablet device.~     The pre-loaded tablets will be provided to adults with T2DM (age 60+ with high glucose). The~     software will allow the patients to record diabetes self-care activities (exercise, glucose,~     nutrition, medication adherence), pursue goals, support communication between the patient and~     a health coach, support communication between peer patients, and visualize health status more~     easily by patients and providers. This research program will enroll 88 patients (4~     intervention groups of 12 persons each and a 40-person control group) in a 90-day pilot study~     to test and refine the design of the application and its effectiveness in supporting care~     plan goals.~      Primary Aim 1: Design, implement, and optimize a motivation psychology-based smart engagement~     system (MOSES) for older adults with diabetes.~      Secondary Aim 2: Determine if providing older adult diabetic patients to care managers and~     peers via a digital tablet-based software application leads to improved diabetes management~     as measured by blood glucose control.~      Secondary Aim 3: Refine the personality attributes used to tailor the interaction with the~     application.~   "
110033|NCT02127203|"~     Periodontitis is a chronic inflammatory disease whose etio-pathogencity is not fully~     understood yet. Reactive oxygen species (ROS) and reactive nitrogen species (RNS) are~     involved in physiological and pathological processes. Nitro-oxidative stress has been~     implicated in Periodontitis.~      The aim of this study is to assess the levels of ROS and RNS in serum and gingival crevicular~     fluid (GCF) samples taken from periodontitis (chronic and aggressive) patients and healthy~     controls. Subsequently, correlating these levels with the severity of periodontal disease.~      Eighty subjects will be invited to participate in this study. Patients will be allocated into~     four groups (20 patients each). The biochemical parameters that will be investigated are~     Malondialdehyde (MDA) (using TBRSA assay) as a marker of oxidative stress and (NO- level~     using Griess reagent) as a marker of nitrosative stress.~   "
110034|NCT02127190|"~     This will be the first-in-human (FIH) study with CXA-10. The main purpose of this trial is to~     demonstrate the tolerability, safety and pharmacokinetics (PK) of CXA-10 at various~     incremental doses, and to demonstrate the safety and tolerability of the rate of the emulsion~     vehicle infusion in healthy volunteers. In addition, associated pharmacodynamic (PD) effects~     of CXA-10 will be investigated.~   "
110035|NCT02127177|"~     The increased risk of atherosclerotic morbidity and mortality in patients with obstructive~     sleep apnea (OSA) has been linked to hypertension, insulin resistance, dyslipidemia, and~     systemic inflammation. The relationship regarding obstructive sleep apnea (OSA) and lipidemia~     and systemic inflammation is far from conclusion for obesity as a strong confounding factor.~   "
110036|NCT02127164|"~     Emergent abdominal surgeries have very high rate of wound contamination due to exposure to~     bacteria from GI tract. There are several different approaches to wound management in these~     patients including wet-to-dry dressing or application vacuum assisted device on the wound.~     The investigators propose using the vacuum assisted device with Dakin's solution on patients~     undergoing emergency surgery for hollow viscus perforation installed immediately at the end~     of operation and remained there for the first 3 postoperative days, followed by delayed~     primary closure on postoperative day 4. The investigators believe this technique can achieve~     earlier wound closure, decrease patient discomfort, improve cost savings, and potentially~     standardize and revolutionize the investigators management of heavily contaminated wounds.~   "
110055|NCT02126917|"~     To determine the influence of co-ingestion of alcohol on HC-ER.~   "
110056|NCT02126904|"~     The investigators compared the time to recurrence after ranibizumab or aflibercept loading in~     patients with AMD.~   "
113076|NCT02087384|"~     This study evaluates vaccination with the quadrivalent HPV vaccine (Gardasil) versus placebo~     vaccination on prevention of high grade AIN recurrence in HIV-positive MSM (men who have sex~     with men) who were successfully treated for high grade AIN.~   "
110037|NCT02127151|"~     A Single Arm Phase II Trial of BMN 673 for Inoperable, Advanced Endometrial Cancer With~     Retrospective PTEN, MSI and MRE11 Analysis~      PTEN= Phosphatase and tensin homolog MSI= Microsatellite instability MRE11= Double-strand~     break repair protein MRE11A~      This trial will investigate whether the drug BMN 673 has therapeutic benefit in the treatment~     of advanced endometrial cancer. Nearly 8,000 patients are diagnosed with endometrial cancer~     in the UK every year. A significant proportion are either diagnosed with advanced disease~     which may be inoperable and/or metastatic (i.e spread to other organs outside the~     endometrium), or curable disease which relapses following first line treatment. There is no~     established standard of care for these patients as both chemo and hormone therapy has limited~     effectiveness and survival benefit. Survival rates have not improved in the past 20 years.~     Furthermore there are no so called 'targeted' drugs licensed for its treatment i.e. drugs~     that block the growth and spread of cancer by interfering with specific molecules involved in~     tumor growth and progression. This leaves an unmet need for effective systemic treatments for~     advanced, inoperable and metastatic endometrial cancer.~      BMN 673 has been shown to be potentially effective in treating cancers known to behave~     similarly to endometrial disease, both in the laboratory and in Phase I studies involving~     patients with advanced cancers. Similarly the drug appears to be relatively tolerable. A~     Phase II trial such as the one proposed by this application could demonstrate activity that~     might lead to a new effective treatment for patients with inoperable, advanced, recurrent or~     metastatic endometrial cancer, while the proposed substudy also presents the possibility of~     discovering a subset of patients more likely to derive benefit from BMN 673.~      This trial is for adult women (18 and above) with advanced, inoperable or metastatic~     endometrial cancer. Patients will be recruited from approximately 15 National Health Service~     (NHS) Trusts based in the United Kingdom (UK). The study is expected to last approximately~     18-24 months in terms of recruitment time, and a maximum of 100 eligible women will be~     registered. All patients will receive BMN 673 until their disease worsens or their doctor~     decides they should stop treatment.~   "
110038|NCT02127138|"~     A Prospective Multi-center Randomized Trial Assessing the Efficacy and Safety of Active~     Transfer of Plaque vs. Provisional T Stenting for the Treatment of Unprotected Distal Left~     Main Bifurcation Lesions~   "
110039|NCT02127125|"~     The purpose of this study is to determine whether microbiome modulation and an experimental~     reduction in plasma LPS concentration improve inflammation and insulin action in insulin~     resistant (obese and T2DM) subjects.~   "
110040|NCT02127112|"~     This study with compare the ridge dimension changes for a block allograft vs. a demineralized~     bone matrix moldable allograft.~   "
110041|NCT02127099|"~     Obstructive sleep apnoea (OSA) is a condition in which a person's sleep is disrupted with~     momentary periods of apnoea and hypopnoea. This occurs when there is a blockage to airflow.~     When this happens, the patient will snore, gasp or choke in the attempt to attain more~     oxygen. This results in disrupted sleep and the patient may even awake from sleep.~      It has been found that a great proportion of Malaysians have habitual snoring and with the~     increase in obesity over the years, it is a concern that OSA may be prevalent in Malaysia.~      However, it has been seen that OSA is commonly undiagnosed in patient. This poses a worry~     because these people can come in for surgery. Diagnosis of OSA before surgery is important in~     order to prepare for the complication related to OSA.~   "
110042|NCT02127086|"~     The purpose of this project is to test an innovative method for managing pain in acutely ill~     hospitalized patients who are not able to report their pain verbally to health care~     professionals. Nurses will use a Pain Assessment and Intervention for the Non-communicative~     (PAIN) Algorithm to guide assessment of pain, selection of pain medications, and management~     of medication side effects. The researchers will evaluate whether patients who are managed~     with the PAIN Algorithm have less severe pain and increased use of pharmacologic pain~     management strategies than those who are not managed with the PAIN Algorithm.~      The study design is a non-randomized quasi-experimental cohort design with two cohorts who~     will be sequentially studied. In phase 1, patients will comprise the usual care group (UCG),~     or control cohort, defined as receiving pain assessment and management practices that nurses~     are currently performing on the study units. In phase 2 the PAIN Algorithm coupled with~     analgesic order sets will be introduced to nurses and physicians on all participating units~     as the intervention. Patients enrolled in this phase will be considered the intervention~     group (IG), also called the experimental cohort. Nurses will be enrolled from the~     participating inpatient units to provide data on the clinical utility of the PAIN Algorithm~   "
110043|NCT02127073|"~     The purpose of this study is to examine the genetic material called microRNA of three types~     of specimens from women with breast cancer. The study also seeks to examine the effectiveness~     of using a new agent called oxytocin to increase the amount of nipple fluid that can be~     collected during surgery.~   "
110044|NCT02127060|"~     Postoperative pain management remains a major challenge for surgeons. Despite huge~     technological advances in pain management, many researchers have documented that unrelieved~     pain remains common after surgeries, which is estimated that up to 75% of patients do not~     achieve adequate pain relief postoperatively. The major goal in the management of~     postoperative pain is to minimize the dose of medications to lessen the side effects while~     still providing adequate analgesia, because side effects of commonly used pain medications~     are known to be the reasons that could lead to inadequate postoperative pain treatment. This~     goal is best accomplished with multimodal analgesia. One agent that can exert antinociceptive~     and pain reducing effects is vitamin C.~      Vitamin C (ascorbic acid) is water-soluble, found throughout the body and is especially~     highly concentrated in the brain, which has antioxidant and neuroprotective properties.~     Moreover, it has been proven that the plasma vitamin C concentration decreases after surgery~     and the requirement for vitamin C increases in surgical patients, possibly due to greater~     demand caused by increased oxidative stress. Regarding the effect of vitamin C on acute pain,~     a result from a recent study with the aim to evaluate the potential role of vitamin C in~     reducing acute pain after laparoscopic cholecystectomy showed that supplementation with oral~     vitamin C significantly decreased morphine consumption after surgery.~      Although vitamin C has potential for relieving postoperative pain, there has not been studied~     regarding the effectiveness of vitamin C for spine surgery, to date. This trial aimed to~     evaluate the effectiveness of vitamin C for surgery of lumbar spine.~   "
110057|NCT02126891|"~     To attest if a cardiac fatigue appears (and to measure it if it does) during intense physical~     exercises in two groups of subjects:~        -  Canoeists from a training center of the French canoeing team during an intensive session~          of three weeks of endurance training;~        -  Young recruits in military school of officers in ground forces of the French army during~          an intensive.~   "
110186|NCT02125214|"~     Temporal dynamics of the EEG microstates show scale-free monofractal properties. This means~     that information is encoded in the same way at different scales. It may be postulated that~     these monofractal properties of the EEG microstate sequences constitute a necessary~     prerequisite of consciousness. We postulate that clinical variations of consciousness may~     also be linked to alterations of fractal properties of EEG microstates.~   "
110045|NCT02127047|"~     Increasing evidence suggests pancreatic islet beta-cell regeneration occurs throughout the~     course of the disease in patients with type 1 diabetes. Therefore, decreased beta-cell mass~     in type 1 diabetes may be improved through inhibition of beta-cell destruction and~     stimulation of proliferation, even after prolonged duration of disease.~      Physical activity improves insulin secretion via unknown underlying mechanisms. We recently~     observed that Interleukin-6 induces glucagon like Peptide (GLP)-1 production and release from~     the islet alpha-cell and the intestinal L-cell. Furthermore, exercise induces release of~     Interleukin-6 from skeletal muscle resulting in elevated circulating Interleukin-6 levels.~     Therefore we hypothesize that exercise-induced Interleukin-6 promotes glucagon like peptide-1~     secretion from the islet α-cell and the intestinal L-cell, thereby providing a mechanism how~     physical activity can help maintain and improve beta-cell function in patients with type 1~     diabetes. This mechanism can be enhanced by concomitant dipeptidyl peptidase-IV inhibition.~      Physical activity is also known to enhance insulin sensitivity and to attenuate the immune~     system activity.~      Therefore by combining physical activity and dipeptidyl peptidase-IV inhibition we aim to~     allow for beta-cell regeneration in a interventional randomized open-label study.~   "
110046|NCT02127034|"~     The purpose of this study is to evaluate the effect of steady state solifenacin and~     mirabegron on the pharmacokinetics of co-administered steady state digoxin. This study will~     also evaluate the safety and tolerability of the combined steady state administration of~     solifenacin, mirabegron and digoxin.~   "
110047|NCT02127021|"~     Up to now, the studies concerning nutritional assessment after pancreatic resection were~     rare. The low-dose pancreatic enzyme treatment after pancreatectomy showed no significant~     benefit in terms of nutritional status. This study is a multicenter randomized phase IV study~     by using high-dose Norzyme® (40,000 IU) to evaluate quality of life and nutritional status~     after pancreaticoduodenectomy.~   "
110048|NCT02127008|"~     Posterior lumbar epidural fat commonly had been considered a simple space-filling tissue.~     Anatomic studies on posterior epidural space and its contents are few, including semifluid~     property. In other words, there has not been studied thoroughly regarding the significance~     and role of posterior epidural fat in lumbar spine. In adults, epidural fat situated in the~     posterior triangle limited by the lamina, the ligamentum flavum, and the posterior surface of~     thecal sac. The fat tissue was covered by a thin membrane of connective tissue, which were~     free under this layer. The anterior surface of this membrane lay close to the dura mater~     without any attachment.~      To date, the epidural fat has been resected routinely by pituitary forcep and suction~     drainage during posterior lumbar surgery. However, the investigators focused on the role of~     epidural fat, which might be associated with postoperative outcome. The investigators thought~     that this peculiar character, epidural fat, should be caused by certain etiologies. In~     general, each tissue, such as epidural fat, has its inherited features and significance,~     thereby the epidural fat has also specific role. However, there has not been fully studies~     regarding it. Thus, the investigators aimed to evaluate the impact of the posterior epidural~     fat on the postoperative outcomes such as pain intensity and functional outcomes by whether~     the epidural fat would be resected or not during posterior decompressive surgery. The~     investigators hypothesized that the epidural fat would be associated with postoperative pain~     intensitive, functional outcomes, and complications of the surgery such as failed back~     surgery syndrome. In this study, new device for resection of epidural fat was not utilized,~     but just resected with conventional devices such as pituitary forcep.~   "
110049|NCT02126995|"~     This study is a multisite, randomized, double-blind, placebo-controlled, phase 2 study of~     MG01CI (low dose and high dose once daily) for 6 weeks compared with placebo in a 1:1 ratio~     of 60 adolescent and adult subjects with Fragile X Syndrome (FXS). Following Screening,~     subjects will be randomized to MG01CI or matching placebo at Baseline (Day 0) and the 6 week~     Double-blind Treatment Period will begin on Day 1.~      The first 4 weeks of the treatment period will be a dose-optimization period,~      All subjects will start with two daily tablets: low dose metadoxine or matching blinded~     placebo. At weekly visits/phone assessments, the investigator will evaluate the dose based~     upon the investigator's assessment of safety and tolerability. If the subject demonstrates~     safety or tolerability concerns with the low dose after 1 or 2 weeks of treatment, then the~     subject will be discontinued. If there are no concerns about safety and tolerability after 2~     weeks of treatment, then the dose will be increased to high dose or placebo. If at the high~     dose there are concerns about safety and tolerability, then the dose will be either kept the~     same or reduced to low dose for the remainder of the treatment period.~      There will be a 2-week Follow-up Period after the last dose of study treatment or early~     termination.~   "
110050|NCT02126982|"~     Clopidogrel besylate (CB) is not differentiated relative to the orignal clopidogrel hydrogen~     sulfate (CHS) in the pharmacokinetics and in antiplatelet potency in healthy volunteers. In~     addition,CB exhibits similar pharmacodynamic properties compared to CHS in patients with a~     history of acute coronary syndrome (ACS) and in patients with ACS undergoing percutaneous~     coronary intervention (PCI). However, there is a lack of data on the clinical efficacy and~     safety of this salt to the original salt in patients with cardiovascular disease. The aim of~     this study is to investigate the clinical efficacy and safety of CB in relation to that of~     CHS in patients eligible to receive clopidogrel.~   "
110051|NCT02126969|"~     The primary hypothesis of this study is that hyper-radiosensitivity (HRS) seen at extremely~     low doses of radiation can be exploited to enhance the effect of chemotherapy, and that this~     effect differs from the cellular effect of higher, standard fractions of radiation used in~     traditional radiation treatment paradigms.~   "
110052|NCT02126956|"~     The study was conducted to investigate the metabolism and mass balance of ACT-128800, and to~     identify the elimination pathways (metabolism and excretion) of ACT-128800 and compare them~     with the known metabolic profiles of ACT-128800 in animals.~   "
110053|NCT02126943|"~     Prospective observational drug registry developed to characterize the safety profile~     (including primarily potential serious hepatic risks) and to describe clinical~     characteristics and outcomes of patients newly treated with Opsumit in the post-marketing~     setting.~   "
110066|NCT02126774|"~     HEP is a five-year, prospective, observational study whose primary goal is to identify~     clinical characteristics and biomarkers predictive of disease outcome, progression, and~     treatment response in participants with newly treated focal epilepsy.~   "
110058|NCT02126878|"~     Inflammation of the trochanteric bursa is a common cause of hip pain. A bursa is a closed~     fluid filled sac or sac-like cavity found between tissues that function as a gliding surface~     to reduce friction. Bursitis is the inflammation of the bursa. Inflammation between the~     trochanteric process of the femur and gluteus medius tendon/ iliotibial tract is the cause of~     trochanteric bursitis. Several treatments exist for trochanteric bursitis, including a local~     steroid injection. The injection consists of a mixture of local anesthetic and steroid~     medications. The steroid is routinely mixed with a local anesthetic. The anesthetic acts to~     diluent the steroid as well as act as a pain reliever. Various steroid preparations have been~     used, at varying doses, for trochanteric bursitis. The steroid preparation, triamcinolone is~     commonly used for various reasons. Besides the procedure associated and injection site risks,~     risks associated with the use of steroids, though rare, exist. Short term, the steroid can~     raise blood sugar levels and should be used with caution and be appropriately monitored in~     diabetics. Additionally, the steroid can suppress the immune system. Long-term risks are~     related to the dose and frequency of use. These risks include thinning of the skin, easy~     bruising, weight gain, elevated blood pressure, cataract formation, thinning of bones and~     joints. Studies have shown the effectiveness of local steroid injections for trochanteric~     bursitis. Unfortunately, there is limited data on the ideal dose of the steroid preparation.~     Triamcinolone of 40mg/ mL is commonly used, but, studies have shown effectiveness at various~     doses, ranging 20 to 160 mg/mL. The aim of this study is to evaluate and compare the~     effectiveness of local steroid injections of various steroid dosages for the treatment of~     trochanteric bursitis.~   "
110059|NCT02126865|"~     The primary objective of this trial is to investigate the safety and tolerability of BI~     1060469 in healthy male and female subjects after oral administration of repeated rising~     doses of 3 mg, 10 mg, 25 mg, 75 mg, 150 mg and 250 mg qd. of 1 day followed by 14 days and in~     asthmatic male and female patients after oral administration of repeated rising doses of 25~     mg and 150 mg qd of 1 day followed by 28 days.~      Secondary objectives are the exploration of the pharmacokinetics (PK) including dose~     proportionality, dose linearity after single and multiple dose segments, pharmacodynamics~     (PD) of BI 1060469 and to describe the PK/PD relationship.~   "
110060|NCT02126852|"~     This study evaluates three different neuromuscular monitoring devices (acceleromyography,~     one- or three-dimensional, and electromyography) with regard to their precision to detect~     residual paralysis after injection of neuromuscular blocking agents and recurrence of~     paralysis after administration of reversal agents in a clinical setting.~   "
110061|NCT02126839|"~     The study is to evaluate the chronic-dose efficacy and the safety of Albuterol MDPI compared~     to placebo in pediatric participants with asthma.~   "
110062|NCT02126826|"~     -  To investigate the safety and tolerability of BI 1026706 in male and female healthy~          subjects and osteoarthritis (OA) patients following oral administration of repeated~          rising doses~        -  To explore the pharmacokinetics after multiple rising doses of BI 1026706 in male and~          female healthy subjects and OA patients~        -  The assessment of pharmacodynamics in OA patients~   "
110063|NCT02126813|"~     Approximately 40 % of all patients undergoing fast-track total hip or knee arthroplasty needs~     intermittent bladder catheterization after surgery, as they are transient incapable of~     voluntary bladder emptying (postoperative urinary retention - POUR). The currently used~     interventional threshold for urinary bladder catheterization are a bladder volume of~     approximately 500 ml., but no evidence exists for this threshold. At the same time, the~     current knowledge suggest, that a bladder volume up to 1000 ml. for 2-4 hours are safe in~     humans, and as the use of urinary bladder catheterization are increasing the risk of~     complications, the investigators are hypothesizing that increasing the interventional~     threshold for urinary bladder catheterization after fast-track total hip or knee~     arthroplasty, will reduce the number of patients needing urinary bladder catheterization,~     without increasing the incidence of urological complications - including urinary tract~     infections.~   "
110064|NCT02126800|"~     Treatment of breast cancer has traditionally been based on the primary tumour's features in~     the breast. Only recently, when cancer returns at other sites, has there been an attempt to~     biopsy the metastatic disease and change treatments accordingly. A 'repeat biopsy' can be~     technically difficult, painful and, when possible, only represents a small sample of one of~     many metastases.~      Even when one deposit responds to a new treatment, a neighbouring one may continue to grow.~     There is an urgent need to characterise all deposits, particularly the lethal ones which~     progress despite all treatments.~      This study will enable the comprehensive analysis of the metastatic process and the evolution~     of the breast cancer through the course of its treatment. Patients who have consented during~     life to donate their tissues for molecular analysis will provide the means for such an~     analysis.~      Main aims:~        -  To comprehensively and systematically examine metastatic breast cancer by its detailed~          exploratory molecular characterization to elucidate the possible inter- and~          intratumoural heterogeneity between the primary tumour and the majority of metastatic~          sites.~        -  To map the natural history of the metastatic breast cancer process~   "
110065|NCT02126787|"~     Background: Psychodynamic and cognitive-behavioral group therapies are frequently applied in~     day hospitals in the treatment of anxiety disorders, and comorbid depressive or personality~     disorders in Poland. There is not enough evidence for its effectiveness in this environment.~     This study addresses this gap. The aim is to determine the effectiveness of the two kinds of~     day treatments consisting of intensive, short-term group therapy: psychodynamic and~     cognitive-behavioral for patients with anxiety disorders and comorbid depressive or~     personality disorders. Our objectives are: 1) Demonstrating effectiveness of each treatment~     in a day care setting relative to wait-list control; 2) Demonstrating the relative short- and~     long-term effectiveness of the two active treatments; 3) Preliminary examination of~     predictors and moderators of treatment response; and 4) Preliminary examination of mediators~     of therapeutic change; 5) Detailed comparison of impact of both methods of treatment on the~     outcome of used measures.~      Methods/design: In this randomized controlled trial, a total of 123 patients with anxiety~     disorders and comorbid depressive or personality disorders will be assigned to one of three~     conditions: 1) psychodynamic group therapy; 2) cognitive-behavioral group therapy; 3) waiting~     list (control group). Therapy will last 12 weeks. Both treatments will be manualized (manuals~     will address comorbidity). Primary outcome measures are include self-report symptoms of~     anxiety, observer rated symptoms of anxiety, global improvement and dichotomized diagnosis of~     anxiety disorder. Secondary outcome measures include personality, depression, self-esteem,~     defense mechanisms, beliefs about self and others, interpersonal problems, object relations,~     parental bonding, meta-cognition, mindfulness and quality of life: symptoms of anxiety,~     depression, personality, self-esteem and defense mechanisms. Measures are taken at baseline,~     post-treatment and 3 months following the end of the therapy.~      Discussion: The randomized controlled trial format is used to compare effectiveness of~     intensive group cognitive-behavior therapy and intensive group psychodynamic therapy for~     anxiety disorders and comorbid depressive or personality disorders. The rationale is to~     investigate how effectively anxiety disorders and comorbid personality disorders can be~     treated in a day hospital typical for Polish healthcare system in 3 months treatment.~   "
126720|NCT01908803|"~     The purpose of this study is to evaluate a single application of AL-60371/AL-817 Otic~     Suspension relative to ototopical CIPRODEX for sustained clinical cure, microbiological~     success, and time to cessation of otorrhea.~   "
110070|NCT02126722|"~     H. pylori infection is the most important causative agent of gastritis, and subsequent~     atrophic gastritis. The endoscopic diagnosis of H. pylori infection relies on urease tests~     such as the Clo test. However, treatment with proton pump inhibitors (PPI) impairs the~     diagnostic yeld of urease tests. The EndoFaster test (NISO BioMed, Turin, Italy) is a new~     technology that has the advantage, over conventional urease tests, of a real-time analysis of~     the gastric juice that can provide information regarding Helicobacter pylori infection and pH~     value of the gastric contents. A well designed clinical study is therefore warranted to fully~     assess the performance of the EndoFaster test in detecting H. pylori infection in patients~     treated with PPI. We aim to perform a clinical study in an adult population in United Kingdom~     in order to determine the diagnostic accuracy of the Endo Faster test compared to the Clo~     test, histological diagnosis and the faecal antigen test in evaluating H.pylori infection.~     Patients on PPI will undergo a gastroscopy with multiple biopsies and during the exam NISO~     Biomed EndoFaster test, as well as the Clo test, will be carried out. H. pylori faecal~     antigen test will also be performed and used as gold standard. Diagnostic accuracy of the~     different methods will be determined.~   "
110071|NCT02126709|"~     Importance This will be a proof of concept study - whereby we hypothesize that Repigel may~     represent a paradigm shift in global acne treatment.~      Historically, there has been a dearth of clinical evidence in this use of povidone-iodine for~     inflammatory acne. This is likely due to staining related to iodine use, which is not~     acceptable to consumers.~      The trial drug, Povidone Iodine, however, becomes colourless and odourless in a matter of~     seconds after application on the skin.~      This represents an ideal product for which we may perform testing to look at its efficacy in~     the management of acne.~      A mainstay in the pathogenesis of acne involves the overgrowth and proliferation of skin~     micro-organisms, primarily proprionibacterium Acnes. Long term antibiotic therapy is usually~     prescribed for a period of 3 to 6 months or more.~      Previous studies have revealed this form of antibiotic therapy is ineffective, patients are~     usually poorly compliant, and also results in the formation of antibiotic resistant~     micro-organisms,which in turn reduces treatment efficacy.~      Potential Benefits~      As such, Povidone Iodine with its antiseptic property represents a promising avenue for the~     elimination of Proprionibacterium Acnes without the associated problems of long term~     antibiotic use, and the development of antibiotic-resistance. It is cosmetically acceptable,~     affordable, and easy to use.~   "
110072|NCT02126696|"~     This study is conducted in a cohort of HIV-positive patients on first-line anti-retroviral~     therapy (ART) in rural health facilities in Lesotho, Southern Africa. It examines virologic~     treatment failure as well as chronic communicable and non-communicable comorbidities among~     patients on ART. The study has two phases. Phase 1 consists of a cross-sectional survey to~     determine prevalence of treatment failure as well as the prevalence of the following~     comorbidities: diabetes mellitus, arterial hypertension, dyslipidemia, depression, alcohol~     use disorder, hepatitis B and hepatitis C. Phase 2 is a cohort study, where patients with~     treatment failure or a comorbidity or both are followed-up for 12 months.~   "
110073|NCT02126683|"~     Hashimoto's thyroiditis (HT) is a common form of autoimmune thyroid disease, which affects up~     to 2% of general population. The annual incidence of HT worldwide is estimated to be 0.8 -~     3.5 cases per 1000 persons. The thyroid gland attacked by a variety of cell- and~     antibody-mediated immune processes. Various auto-antibodies may be present against TPO and~     Tg, and ADCC is a substantial factor behind the apoptotic fall-out of HT. Activation of~     cytotoxic T-lymphocytes in response to cell-mediated immune response affected by helper~     T-cells is central to thyrocyte destruction. Recent studies showed higher pro-inflammatory~     cytokines in serum of patients with HT, and suggested HT is associated with regulatory~     T-cells dysfunction, imbalance of ratio of Th1 cell and Th2 cell, overexpression of Th17~     cells.~      Several studies suggested that pregnant women with HT, even at euthyroid state had higher~     risk of spontaneous miscarriage, more frequent post-partum depression and higher depressive,~     anger, and total mood disturbance risk compared to those without HT. Presence of thyroid~     auto-antibodies is also associated with negative pregnant outcomes including gestational~     hypertension, late abortion, fetal death, premature delivery and neonatal respiratory~     distress. Neonates from mothers with ATD have higher rate of transient hypothyroidism.~     Children of mothers with ATD had higher risk of positive serum thyroid auto-antibodies and~     development of goiter and thyroid dysfunction. However, there is no suggested treatment for~     subjects with HT who have normal thyroid function. Low-iodine diet and regularly follow-up~     were suggested.~      Plaquenil (hydroxychloroquine) is an anti-malarial agent, and has been used to treat several~     autoimmune diseases, including lupus erythematosus and rheumatoid arthritis for more than a~     century. It reduced lymphocytes, production of auto-antibodies, cytokines, and immune~     mediators, NK cell activity, and inhibits antigens presenting to CD4 T-cells of B cells,~     dendritic cells and monocytes.~      This study focuses on the effect of Plaquenil on thyroid auto-antibodies, inflammatory~     markers, cytokines, and goiter size in euthyroid women with HT.~   "
110074|NCT02126670|"~     The purpose of this study is to determine whether or not ACT01 is effective and tolerable~     alone or when used in combination with Comp01, Comp02, Comp03 or Comp04 in patients with~     facial and/or scalp keratosis.~   "
110075|NCT02126657|"~     Our study involves the evaluation of a high potency chemical peel in its efficacy and safety~     profile for the treatment of acne scars. This chemical peel regime is a high potency peel of~     70% glycolic acid combined with vitamin C that is purported to provide a good balance between~     yielding results and patient safety. We aim to evaluate its efficacy and safety profile of a~     single application. The study design is based on a single group that compares pre- vs~     post-intervention. 10 patients with atrophic acne scars of skin type I-IV will be recruited.~     Potential benefits include improvement of post acne scars with a short downtime and risks~     include post peel hyper pigmentation and scarring. We believe that this treatment will be~     highly beneficial to patients with post acne scarring.~      This chemical peel regime has good efficacy and safety profile for the treatment of acne~     scars.~   "
110076|NCT02126644|"~     Our study involves the evaluation of a high potency peel in its efficacy for skin~     rejuvenation in the treatment of photoaging. This chemical peel regime is a high potency peel~     70% glycolic acid combined with vitamin C that is purported to provide a good balance between~     yielding results and patient safety.~      AIM We aim to qualitatively evaluate its efficacy and safety profile.~      Our hypothesis is that a single peel of 70% glycolic acid combined with vitamin C will result~     in improvement of the features of photoaging with few side effects.~   "
110077|NCT02126631|"~     This study is intended to compare the new Carnation Ambulatory Monitoring (CAM) System, a~     patch monitoring system, with the Holter monitoring system. Holters represent the current~     standard for continuous recording of the ECG over extended periods.~   "
110078|NCT02126618|"~     The aim of this study is to estimate the amount of extra urine produced by natural diuresis~     during 20-minute pad test, and assess the effect of diuresis on the accuracy of using~     20-minute pad test to estimate the severity of SUI. Besides, the above results may be used~     for further refinement of the amount of water infusion used for the 20-minute pad test.~   "
110079|NCT02126605|"~     Even though there is growing interest in and use of trained Diabetes Alert Dogs (DADs) as a~     way to monitor blood glucose in type 1 diabetes (T1D), no scientific studies have confirmed~     the ability of DADs to accurately detect extreme high and low blood sugar. The current~     project is the first preliminary investigation into the accuracy of DADs, using~     scientifically rigorous research methods similar to those required to demonstrate accuracy in~     blood glucose meters. The primary aim of the project is to test the hypotheses that DADs are~     accurate at detecting extreme blood sugar levels in adults and children with T1D. The~     proposed project has several other secondary aims, which include determining: 1) the glycemic~     thresholds and time course for hypo- and hyperglycemic DAD alerts, 2) the degree to which~     alert accuracy is consistent across different DADs, and 3) whether or not DAD owners appear~     to experience better psychosocial status and quality of life compared to other individuals~     with T1D.~   "
110080|NCT02126592|"~     Polycystic ovary syndrome (PCOS) is an endocrine disease in reproductive women. It is~     characterized by anovulation and hyperandrogenism. Most patients with PCOS have metabolic~     abnormalities such as dyslipidemia, insulin resistance and glucose abnormalities. Almost~     60-80﹪PCOS patients are obesity which exacerbates IR and hyperandrogenism. Obese PCOS~     patients tend to be overeating suggests that impaired appetite regulation might be contribute~     to the pathophysiology of PCOS. Our study is trying to observe difference of incretin between~     PCOS and normal control to figure out whether change of incretin is involved in the~     pathophysiology of PCOS.~   "
110081|NCT02126579|"~     The purpose of this study is to learn what effects (good and bad) an experimental vaccine~     (LPV7) plus tetanus peptide and other substances called polyICLC, resiquimod, and Montanide~     ISA-51 have on you and your melanoma. We will also look at whether the experimental vaccine~     and these drugs cause any changes in your immune system.~   "
110082|NCT02126566|"~     Striae distensae is a common skin condition that rarely causes significant medical problems.~     However, it often results in a considerable amount of distress to those with the condition.~     Various modalities of treatments have been used for striae distensae but few have led to~     satisfactory results.~      More recently, newer techniques such as pulsed dye laser and radiofrequency devices have been~     used with modest results. There is still, however, paucity of data using light therapy for~     the treatment of this condition. Blue light therapy using the Multiclear device has been used~     successfully in the treatment of acne. In contrast, there is little data to suggest its use~     in the management of striae distensae.~      We aim to study the effects of blue light on the treatment of striae distensae and whether~     this can be used safely to manage this condition.~   "
110083|NCT02126553|"~     The goal of this clinical research study is learn if Revlimid® (lenalidomide) can help to~     keep acute myeloid leukemia (AML) patients in remission. The safety of this drug will also be~     studied.~      This is an investigational study. Lenalidomide is FDA approved and commercially available for~     the treatment of myelodysplastic syndrome (MDS) and multiple myeloma (MM). Its use in~     patients with high risk AML that is in remission is investigational.~      Up to 50 participants will be enrolled in this multicenter study. All will take part at MD~     Anderson.~   "
110084|NCT02126540|"~     To evaluate the safety and effectiveness of the Pantheris System to perform atherectomy while~     using directional visualization and imaging as an adjunct to fluoroscopy to aid removal of~     plaque from diseased lower extremity arteries.~   "
110085|NCT02126527|"~     This phase I clinical trial studies the side effects and best dose of auranofin and sirolimus~     when given together in treating patients with non-small cell lung cancer. Immunosuppressive~     therapy, such as auranofin and sirolimus, may be an effective treatment for non-small cell~     lung cancer. Sirolimus may also stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Giving auranofin and sirolimus may be an effective treatment~     for non-small cell lung cancer.~   "
110086|NCT02126514|"~     This study will be an open-label, non-randomized, absorption, metabolism, and excretion study~     to evaluate the mass balance, metabolite profiles, and rates and routes of elimination of~     [14C]-AZD3293 and derived metabolites following administration as a single 100-mg (containing~     approximately 150 µCi) oral dose (as an oral solution)~   "
110087|NCT02126501|"~     To compare the 2 methods of weaning of nasal continuous positive airway pressure (CPAP) in~     premature babies born between 26 and 32 weeks~   "
110088|NCT02126488|"~     The long-term objective of this research is a prophylactic approach that can reduce the~     incidence of falls and the resulting injuries among older adults at risk and thus reduce its~     escalating medical cost. This project explores perturbation training through the use of~     treadmill device and a motor learning approach, in which experience with slip-like~     perturbation generated by that treadmill is used to prepare the motor system to develop and~     then put to use fall-resisting skills outside of training environment (cross-environment~     transfer). The computer-controlled treadmill is portable, safe and easy to operate, thus~     conducive for use in clinics or community centers. The study logically builds on and~     complements the team's previous and current research programs, and will further test that~     after such a single session, older adults at risk can retain such cross-environment transfer~     and reduce their likelihood of falls in everyday living for the next 6 to 12 months. Finally,~     the study will explore that such reduction of falls does not come merely from these persons'~     familiarity with the training or testing setup, protocol and environments.~   "
110095|NCT02126397|"~     Hysteroscopy today is considered the gold standard for the diagnosis and treatment of~     endometrial polyps. In recent years we have used the bipolar energy for resection of polyps~     by hysteroscopy, becoming a routine clinical practice and universally accepted.~      Resection of endometrial polyps laser energy has recently begun to be used with satisfactory~     results, so studies are needed to analyze these results and compare it with the usual~     techniques .~      This time in advance of medicine, it is appropriate to introduce minimally invasive~     procedures , allowing resection of endometrial polyps on an outpatient basis without~     anesthesia and acceptable to most patients.~      These procedures assume a lower cost and are associated with a lower surgical risk due to~     their realization without anesthesia .~      Hypothesis: Resection of polyps outpatient laser diode has a similar or superior to that of~     the bipolar electrode tolerability. The diode laser is a viable , quick , simple technique~     with a high percentage of resection and high degree of satisfaction of patients~   "
126721|NCT01908790|"~     The purpose of this study is to establish the accuracy of the non-invasive Mespere Oximeter~     that estimates venous oxygen saturation.~   "
110089|NCT02126475|"~     Although major progresses were realized during recent years, temporal cognition is still~     poorly understood. However, abnormal temporal cognition is an underestimated aspect of~     several neurological disorders, particularly if basal ganglia (BG) are affected. Therefore,~     the interest of studying temporal cognition is double: firstly, it is an essential function~     necessary to guide all behavior; secondly, it seems to be very sensitive to the integrity of~     dopaminergic pathways. It is well known that Parkinson's disease (PD) is partly due to a~     degeneration of neurons producing dopamine in the Substantia Nigra pars compacta (SNc).~     Therefore, in this project, PD patients and healthy volunteers will be used as a model to~     study the role of dopamine in temporal expectation.~      An expectation is an internal representation of an event that is likely to occur in the~     future. Temporal expectation builds-up as time elapses before the upcoming event. The role of~     temporal expectation in the oculomotor domain has often been studied using anticipatory eye~     movements as a tool. Indeed, expectation evokes anticipatory eye movements. However, to the~     knowledge of the investigators, expectation and anticipation have so far been studied in~     experimental tasks where temporal information is essential but not voluntarily controlled.~     This is usually referred to as 'automatic' or 'emergent' timing: the timing of the eye~     movement adapts to the timing of the target, implicitly and without voluntary control of the~     subject. However, anticipatory movements can also be based on an explicit estimation of time,~     e.g. during music playing. In summary, timing can be based on cognitive (explicit) or~     automatic (implicit) processing. The originality of the behavioral task the investigators~     will use in this study is that it will require an explicit comparison of a memorized duration~     with elapsing time in order to anticipate target appearance. In this task, expectation of the~     upcoming event will build up on explicit temporal information.~      Same PD patients will be tested under treatment (ON) and without treatment (OFF) to~     determine the effect of dopamine in time expectation . Only levodopa responsive Parkinson~     patients will be included and among them only those receiving levodopa and/or dopa agonists~     three times daily at a stable dosis since 30 days.~      the investigators hypothesize that eye movements latency will not linearly covary with~     objective time in OFF PD patients. In treated PD patients, a recovery of the linear~     relationship between subjective and objective time is expected. This would clearly~     demonstrate the role of dopamine in temporal expectation in humans.~   "
110090|NCT02126462|"~     Na-GST-1 and Na-APR-1 are proteins expressed during the adult stage of the Necator americanus~     hookworm life cycle that are thought to play a role in the parasite's degradation of host~     hemoglobin for use as an energy source. Vaccination with recombinant GST-1 or APR-1 has~     protected dogs and hamsters from infection in challenge studies. This study will evaluate the~     safety and immunogenicity of co-administering Na-GST-1 and Na-APR-1 to healthy Gabonese~     adults living in an area of endemic hookworm infection.~   "
110091|NCT02126449|"~     Preclinical studies provide strong support for the concept that fasting evokes resistance to~     multiple forms of stress. Fasting reduces plasma levels of growth factors and modulates~     intracellular nutrient sensing systems, thereby diverting energy from growth to maintenance.~     Accordingly, the currently available preclinical evidence suggests that short-term fasting~     protects normal cells against the perils of chemotherapy. In contrast, cancer cells are not~     protected, as a result of their self-sufficiency in growth signals. This phenomenon is termed~     Differential Stress Resistance (DSR). DSR reduces the severity of toxic side-effects of~     chemotherapy and interestingly, it simultaneously renders cancer cells more vulnerable to~     chemotherapeutics. Importantly, extensive preclinical evidence and preliminary clinical data~     indicate that a specifically designed very low calorie, low amino acid substitution diet~     (Fasting Mimicking Diet, FMD) has effects on cancer therapy that are very similar to those~     of fasting. This study aims to evaluate the impact of the FMD on tolerance to and efficacy of~     neoadjuvant chemotherapy in women with stage II or III breast cancer.~   "
110092|NCT02126436|"~     The purpose of this study is to evaluate the feasibility and effectiveness of acupuncture for~     the treatment of phantom limb syndrome in lower limb amputees and pilot an acupuncture~     protocol. The study will be a comparative effectiveness study comparing acupuncture and~     standard care versus standard care alone and will be a randomised controlled trial using a~     mixed methods approach. The study hypothesis is a course of acupuncture will reduce the~     symptoms of phantom limb syndrome in lower limb amputees.~      The study will be based the Amputee Rehabilitation Unit, London. Twenty lower limb amputees~     with phantom limb syndrome will be randomly assigned to either receive usual care or usual~     care plus acupuncture. Acupuncture intervention will include 8 treatments over 4 weeks and~     treatment will involve using both body and auricular acupuncture points. Usual care will~     include physiotherapy, occupational therapy, pharmacological intervention and other~     interventions as deemed appropriate by clinical staff.~      An eleven point numerical rating scale will be the primary outcome measure in this study.~     Secondary outcome measures will include the Short Form McGill Pain Questionnaire 2, EQ-5D-5L,~     Hospital Anxiety and Depression Scale, Perceived Stress Scale, Insomnia Severity Index,~     Participant Global Impression of Change and information will also be obtained on rescue~     medication. A cheek swab will also be taken to explore potential subgroups of responders in~     relation to the genetic polymorphism of the glucocorticoid receptor. Outcomes will be~     recorded weekly for the duration of the study and one and three months post completion of the~     study. In order to identify protocol acceptability and acceptability of outcome measures five~     participants will be interviewed post completion of the study. Data will also inform~     feasibility such as recruitment rate, completion rate and reasons for dropout.~      Data from this study will guide the development of a full randomised controlled trial.~   "
110093|NCT02126423|"~     The administration of short courses of topical antibiotic drops before and/or after~     intravitreal injections is a common practice, but increasing evidence suggests this may not~     lower the risk of infectious endophthalmitis and could increase rates of antimicrobial~     resistance. The purpose of the present study is to determine the antimicrobial resistance~     profiles in patients who have received numerous (≥ 20) courses of antibiotics for~     intravitreal injection compared with untreated controls.~      This study compares 20 control patients without prior intravitreal injection to 20 patients~     who have undergone ≥ 20 prior intravitreal injections accompanied by a course of topical~     antibiotics for two days before and/or after the injection procedure. The lower, inner eyelid~     and nasal cavity were cultured and evaluated via disk diffusion method for antimicrobial~     sensitivity.~   "
110094|NCT02126410|"~     1. BACKGROUNDS: Currently, elderly people comprise more than 10% of the total Taiwanese~          population. However, within the context of self-reported sleep duration and health~          risks, research into the association between sleep duration and body composition changes~          in older people is limited. It is important to gain an understanding of such an~          association of older people to estimate the public health burden.~        2. OBJECTIVES: To assess the association between self-reported sleep duration and~          sarcopenia as well as obesity in community-dwelling older adults.~        3. HYPOTHESIS: Self-reported sleep duration is associated with prevalence of sarcopenia and~          obesity in community-dwelling older adults.~        4. DESIGN: A cross-sectional investigation.~        5. SETTING: Communities in Zhongzheng district, Taipei.~        6. PARTICIPANTS: Four hundred and forty-eight community-dwelling adults (224 men and 264~          women) aged 65 years and older.~        7. MEASUREMENTS: The investigators evaluated self-reported sleep duration by deriving from~          the Pittsburgh Sleep Quality Index and 7-d recall physical activity diary. Skeletal~          muscle mass was estimated by the predicted equation from a bioelectrical impedance~          analysis measurement. The Groningen Activity Restriction Scale and the Chinese Geriatric~          Depression Screening Scale were used to evaluate physical disability and depression,~          respectively.~   "
110096|NCT02126384|"~     The purpose of this study is to determine which B lymphocytes subsets are responsible for the~     production of IgM, IgG2 and IgA anti-pneumococcal capsular polysaccharides after vaccination~     with a 23-valent pneumococcal polysaccharide vaccine.~   "
110097|NCT02126371|"~     LEO 32731 (Study Drug) is an investigational drug which is being developed by LEO Pharma~     A/S (the Sponsor), with an aim to help people with skin conditions called psoriasis. The~     aim (s) of this Study are to determine:~        -  The effects of the Study Drug when given as different formulations intended for oral~          administration (tablets and capsules)~        -  The safety of the Study Drug and any side effects that might be associated with it~        -  The effect of food on the Study Drug~        -  The Study will also measure how much of the Study Drug gets into the blood stream and~          how long it takes the body to remove it and what affect the Study Drug has on the body.~   "
110098|NCT02126358|"~     To evaluate the efficacy and safety of the fix-dose combination therapy with Gemigliptin 50mg~     and Rosuvastatin 20mg with type 2 diabetes and dyslipidemia~   "
110099|NCT02126345|"~     The purpose of this study is:~        -  to generate data to evaluate Orthopaedic Data Evaluation Panel (ODEP) rating to support~          existing short-term clinical results and CE documentation;~        -  to assess the clinical performance of the MASTER SL femoral stem and the DELTA TT~          acetabular cup under standard conditions of use;~        -  to determine any adverse events and assess whether they constitute risks when weighed~          against the intended performance of the device.~   "
110100|NCT02126332|"~     Acute pancreatitis (AP) is a common disease whose incidence in the US reaches 35 per 100,000~     population annually. Its main causes in adults are gallstone migration into the common bile~     duct and alcohol abuse. Approximately 80% of patients with AP will develop a mild disease for~     which the management is mainly conservative. However 20% will develop a severe form, which is~     known to be associated with the development of local complications, such as pancreatic and~     peripancreatic necrosis, pseudocysts, and systemic complications, such as adult respiratory~     distress syndrome or renal failure. In the severe form of AP the mortality rate can reach 17%~     mainly due to multiple organ failure and pancreatic necrosis. In particular, pancreatic~     necrosis is associated with a death rate of up to 40%.~      Epidural anesthesia (EA) is widely used to induce analgesia in the perioperative period and~     has also been used to decrease pain in patients with AP. In addition, experimental studies~     have shown a specific beneficial effect of EA in AP, attributed to an anti-inflammatory~     effect of local anesthetics administered in the epidural space combined with a sympathetic~     nerve blockade, which redistributes splanchnic blood flow to non-perfused pancreatic regions.~      To date, EA has not been adequately tested in intensive care unit (ICU) patients with severe~     AP, with regards to clinical outcome. The objective of our study is therefore to test the~     effect of EA on lung dysfunction during severe AP, as we hypothesize that EA could limit lung~     failure requiring invasive mechanical ventilation (MV) or the duration of invasive MV~   "
110101|NCT02126319|"~     The purpose of this study was to examine whether a cognitive-affective preparation was more~     beneficial, in general, and more specifically for certain subgroups, such as African-American~     men and individuals with high monitoring style.~   "
110102|NCT02126306|"~     Oral administration of betaglucosylceramide was shown effective in reducing inflammation in~     animal models and was found safe in humans.~   "
110103|NCT02126293|"~     Children with chronic kidney disease, even after transplantation, may be at risk for bone~     problems due to an imbalance of calcium and phosphorus in the blood, especially as their~     kidneys progressively fail to function. While some drug and diet treatments are available to~     prevent such bone disease, many children refuse to take them due to bad taste and tummy~     cramps. If calcium and phosphorus status remain abnormal for a long time, hard crystals can~     form in the blood vessels, eventually clogging them and resulting in heart problems.~     Investigators are studying possible new methods to help the kidneys maintain a normal balance~     of nutrients in the blood which is important for growing healthy bones and the prevention of~     side effects in blood vessels that can lead to heart disease. One method is to improve the~     team work of a hormone FGF-23 and a protein called Klotho that together stimulate the kidneys~     to increase phosphate removal. Investigators propose that this problem may be due to low~     blood zinc levels which often occur in children with kidney disease. Thus, in this study,~     investigators propose to first measure zinc in blood from children with chronic kidney~     disease (CKD) or who have had kidney transplants to assess zinc and phosphate status, the~     hormone FGF-23 and its assistant Klotho. If zinc status is low, the children will receive~     zinc supplementation for 3 months. After treatment with zinc, the same blood measurements~     will be repeated to determine if the zinc supplements have helped the hormones to remove~     phosphate from the body. If this pilot project is successful, investigators will then~     consider a larger scale project involving adult patients as well as pediatric patients from~     other pediatric centers. This project will also guide investigators as to whether they need~     to introduce zinc measurements as part of routine testing of CKD and transplant patients. In~     addition to measuring zinc levels in study participants, trace elements (TE) will also be~     measured. These include heavy metals such as cadmium, chromium, nickel, vanadium, copper,~     lead, manganese and selenium. Very little is known about levels and metabolism of TE in CKD~     especially before dialysis. In adults, cadmium, chromium, nickel, and vanadium probably~     accumulate in hemodialysis patients, while copper and lead may accumulate. Manganese,~     selenium are probably deficient. The study will allow investigators to obtain the information~     about TE in this group of pediatric patients.~   "
110104|NCT02126280|"~     The study of proinflammatory and anti-inflammatory cytokines and chemokines expression~     profiles in human monocytes to identify new effective biomarkers that have the best~     diagnostic potential in asymptomatic atherosclerosis.~   "
110105|NCT02126267|"~     Evaluate and compare the effectiveness in a clinical and microbial perspective one stage~     full-mouth disinfection technique in relation to scaling and root planing per quadrant~     associated with chlorhexidine or azithromycin.~   "
110106|NCT02126254|"~     The aim of this trial is to compare the efficacy of NICaS-directed treatment strategy to the~     common treatment strategy (based on clinical judgment) on morbidity and mortality in patients~     with decompensated congestive heart failure, and accordingly to assess whether the NICaS~     system can optimize and individualize the treatment of decompensated heart failure patients.~     A prospective randomized controlled trial in which Known HF patients, with reduced EF <40%,~     admitted due to decompensated HF, will be randomly assigned, in a 1:1: ratio, to either: 1)~     Control group that will be treated in the cardiology and internal medicine departments~     according to the guidelines for the management of Heart Failure. 2) Hemodynamic group~     patients will be examined in the cardiology and internal medicine departments and treated~     according to the NICaS system in addition to current guidelines. Patients in this group will~     be tested within 12 hours from hospitalization and thereafter on an everyday basis until~     discharge. For all patients randomized, therapy will be tailored to the ultimate goal of~     discharge on an oral medical regimen to provide better relief of CHF symptoms, to reduce~     filling pressures and to maintain adequate perfusion. These goals are the same for both~     groups, but in the control group therapy will be adjusted according to clinical assessment~     alone, while in the NICaS-directed group, actual measurement of hemodynamics will be used to~     supplement clinical assessment.~   "
110107|NCT02126241|"~     This proposal aims to evaluate the added clinical and echocardiographic benefit of using the~     non-invasive impedance-based cardiac output measurement system (NICaS) for optimizing~     atrio-ventricular and inter-ventricular delays in chronic (more than 6 months) CRT~     recipients.~   "
110109|NCT02126215|"~     Hypothesis: Patients with blue cerebrovascular reactivity (CVR) regional maps during a~     hypercapnic CO2 challenge will be at greater risk of developing post-operative delirium (POD)~     and stroke following major surgery. The blue CVR map will be shown to be predictive of POD~     and stroke and ultimately represent a diagnostic test for patients at risk. These blue CVR~     maps will enable neurologic risk stratification for patients undergoing major surgery. A~     secondary hypothesis is that location and extent of the blue CVR maps will strongly indicate~     risk of neurologic sequelae after operative procedures. Background: Major surgery is~     associated with a significant risk of postoperative morbidity and mortality. POD is a dreaded~     complication with such anesthesia and surgery. The prevalence of delirium after cardiac~     surgery has been reported to occur in up to 50% of patients. Using a definitive diagnostic~     tool such as the Confusion Assessment Method - Intensive Care Unit (CAM-ICU) results in the~     higher proportion reported. Delirium is a serious complication that results in prolonged~     length of stay, increased health care costs, and higher mortality. As much as $6.9 billion of~     Medicare hospital expenditures can be attributed to delirium. At such a cost, better~     diagnosis and treatment is urgently needed. Pre-emptive diagnosis leading to better~     management of delirium post-operatively is clearly one of the fundamental problems~     confronting modern anesthesia and peri-operative medicine.~      Specific Objectives: The investigators seek to address (a) the identity of patients who have~     the greatest vulnerability to the surgery and (b) investigate the risks and test appropriate~     risk mitigations. Understanding POD is of immense import to help control a hospital's~     surgical and critical care costs. Patients with neurological consequences including POD often~     represent a choke point for optimized critical care utilization. At the very least, improved~     understanding and a diagnostic test to highlight patients at risk of POD would be most~     welcome. Such an advance would permit rational strategies to limit the problem and allow~     better designed therapeutic arcs for patients now known to be at risk. This is especially~     important for patients undergoing complicated major surgery and is the focus of this pilot~     project.~   "
110110|NCT02126202|"~     A multicenter, randomized clinical trial in elderly patients (over 80 years old) with~     unstable angina pectoris or Non-ST elevation myocardial infarction (NSTEMI).~      A total of 200 patients will be randomized to medical treatment (100 patients) or coronary~     angiography with revascularization if feasible (100 patients). Information regarding prior~     history, frailty, clinical presentation, in-hospital events, complications, angina, quality~     of life and mortality will be collected. Follow up time is 1 year.~   "
110111|NCT02126189|"~     This study is designed to refine the aetiological causes of cancers of the head and neck and~     investigate the ways in which human papillomavirus and life-style factors cause head and neck~     cancers. This study will determine if these factors affect the treatment of cancer.~      All patients attending the Head and Neck Clinic at the Princess Alexandra Hospital is invited~     to complete a risk factor questionnaire and give consent for their clinical data and tissue~     samples to be available for future research activities. The risk factor questionnaire is~     based on existing validated instruments developed by the QIMR Berghofer Medical Research~     Institute Cancer Control Group, and will collect standardised information relating to~     demographics and causal factors (tobacco and alcohol intake), risk modifiers (dentition,~     asprin and non-steroidal anti-inflammatory drugs (NSAIDS), height, weight, physical activity,~     diet quality etc) and behaviours (oral sex etc)~   "
110112|NCT02126176|"~     The purpose of this study is to determine whether the dosage of 0.1% tacrolimus ointment~     applied on unit area of eczema influence the efficacy of treatment.~   "
110113|NCT02126163|"~     Excessive alcohol use is associated with a range of serious and costly health, social, and~     economic consequences at the individual and societal level. This program of research serves~     as a venue by which to produce and test an innovative, science-based, and cost-effective~     means to intervene in a private, convenient, and individualized way with employed adults who~     report non-dependent levels of risky drinking. Responsible Drinking offers computer-tailored~     intervention sessions directed at increasing readiness to limit drinking to national~     guidelines for low-risk drinking and a complementary dynamic web portal providing additional~     information, activities, and strategies designed to activate and reinforce the change~     process. The primary objective is to complete and enhance the development of Responsible~     Drinking and test it in an effectiveness trial. In Phase II the program capabilities and~     innovation will expand to integrate the e-Health components (CTI and e-Workbook) with~     m-Health (mobile health) technologies. The e-Health components will be enhanced to offer a~     more interactive and engaging user experience. In addition, m-Health technologies (text~     messaging and mobile device browsing optimization) will be integrated to support engagement~     in the program and flexible delivery options. 996 employed adults will be recruited to~     participate in the randomized trial. The treatment group will receive three intervention~     sessions during the course of six months and group differences on a number of outcomes will~     be evaluated at 12 and 18 month follow-up assessments.~   "
110114|NCT02126150|"~     The UNICORN consists of two collaborating biobanks, one in Utrecht and one in Singapore. From~     these two sites we include all patients who undergo a coronary catheterization for any~     reason.~      At the moment of catheterization we draw blood, which will be stored in a biobank and we~     collect clinical characteristics. Patients are followed-up for 5 years for the occurrence of~     major cardiovascular events.~      By including from two sites in the world we include 4 major ethnic groups: Caucasians,~     Chinese, Indians and Malays. We aim at including at least 2000 patients per ethnic group.~      Our hypothesis is that there are differences in the risk factor burden, clinical presentation~     of CAD, and biochemical patterns in the blood among the ethnic groups.~      Furthermore, this biobank offers a platform for multi-ethnic biomarker discovery.~   "
110115|NCT02126137|"~     Infection by hepatitis C virus (HCV) affects more than 170 million people in the World and~     80.000 in Chile. It causes more deaths than HIV infection in the US and is a leading cause~     for liver transplantation in Chile. Even though treatments are evolving with new direct~     antiviral agents (DAAs) that are increasing response rates, there are several issues with~     these new approaches, including increased toxicity, need for using interferon and ribavirin,~     complex algorithms of treatment, high cost, limited effectivity in certain groups (liver~     transplant patients) and drug interactions. Treatments targeted at host factors required for~     the viral cycle are becoming increasingly explored as an alternative or complement to DAAs.~     It has been recently described that Niemann-Pick C1-like 1 (NPC1L1), the intestinal receptor~     of cholesterol, serves as an entry factor for HCV. NPC1L1 is, therefore, a key transporter in~     the enterohepatic cycle of cholesterol. NPC1L1 can be blocked with ezetimibe, which is an~     approved and generally safe drug used for the management of hypercholesterolemia. Our~     hypothesis posits that blocking HCV entry to the hepatocyte or intestinal HCV reabsorption~     with ezetimibe may have an antiviral effect. In the study, we will administer ezetimibe 20~     mg/d to 20 patients with stable chronic hepatitis C for 12 weeks and assess changes in HCV~     RNA and core antigen in plasma, bile and feces.~   "
110116|NCT02126124|"~     The purpose of the study is to evaluate the safety and efficacy of DTMS compared to sham~     treatment as an aid to smoking cessation in chronic, heavy (>10 cigarettes/day) cigarette~     smokers.~   "
110119|NCT02126085|"~     Sedation vs Intubation for Endovascular Stroke TreAtment Trial (SIESTA) is a prospective,~     randomised controlled, monocentric, two-armed, comparative trial. Patients are randomized 1 :~     1 to either non-intubated state or to intubated state for endovascular stroke treatment.~     Otherwise, no principal differences in intensive care treatment are intended, and standard~     operating procedures are applied to ensure uniform management decisions in fields such as~     ventilation, sedation, cardio-vascular and cerebral monitoring and management.~   "
110120|NCT02126072|"~     Objective: To determine the immediate effects of oral alcohol consumption in healthy~     volunteers on gut wall integrity as measured by I-FABP and LBP.~      Study design: Randomized, single blinded cross over study.~      Study population: 15 healthy adult male human volunteers will be included in this study.~      Intervention: the consumption of alcoholic beverages (1 g/kg ethanol) of wine (12%) compared~     to the consumption of water.~      Main study parameters/endpoints: The aim of this study is to determine the immediate effects~     of oral alcohol consumption in healthy volunteers on gut wall integrity as measured by I-FABP~     and LBP.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: Subjects consume 1g of alcohol per kg bodyweight. One blood sample of 14 ml~     followed by 6 samples of 8 ml will be drawn between 16.45 hours and 19:00 hours the day~     after. The first 6 observations take place in a single visit followed by one observation in~     short visit the next day. It is unlikely that subjects will experience any physical or~     psychological discomfort from the withdrawal of a total of 62 ml of blood in 24 hours or the~     consumption of the amounts alcohol or water mentioned above. The same protocol will be~     repeated one week after the first visit in which the alcohol group and water group are~     crossed over.~   "
110121|NCT02126059|"~     Cognitive function, behavioral and psychological symptoms, and quality of life will improve~     after administration of cognitive stimulation therapy, reminiscence therapy, and~     aroma-massage therapy in patients with dementia.~   "
110122|NCT02126046|"~     Allo-hematopoietic stem cell transplantation(HSCT) is the only way to cure β-thalassemia~     major at present. To expand donor pool，we developed a haplo-identical HSCT (Hi-HSCT)~     platform. But in prior Hi-HSCT using high dose post-transplant Cyclophosphamide in patients~     with leukemia, cytopenia post-transplant often developed, which was considered as a symptom~     of GVHD. Therefore, the investigators add unrelated umbilical cord blood (UCB) to the~     Hi-HSCT. It has reported that, as third-party cells, UCB will reduce GVHD.The purpose of this~     study is to determine whether unrelated UCB following Hi-HSCT can improve outcomes of Hi-HSCT~     in patients with β-thalassemia major.~   "
110123|NCT02126033|"~     Celiac disease is an autoimmune process that causes destructive changes in the epithel of the~     small bowel and it is also a pre-malignant state (e.g lymphoma). The aim of the study is to~     examine telomere length and other parameters of genetic instability from peripheral blood~     lymphocytes of patients with celiac disease compared with healthy controls.~   "
110124|NCT02126020|"~     The Boston Keratoprosthesis type I (KPro) is a prosthetic cornea used to treat several causes~     of corneal blindness. Some categories of patients, including those with auto-immune diseases~     such as Stevens-Johnson syndrome, toxic epidermal necrolysis syndrome and mucous membrane~     pemphigoid, have a higher risk of failure for the KPro. Because of chronic inflammation, the~     cornea supporting the KPro may melt, leading to a higher risk of infection, loss of the KPro~     and loss of the eye.~      Infliximab is an antibody against tumor necrosis factor alpha and is used intravenously to~     control inflammation in several diseases. It has been used in some cases of corneal melting~     with significant success.~      This study's hypothesis is that infliximab can be successfully used as an eye drop (instead~     of the usual administration through veins) and that its regular use may prevent melt in eyes~     with a Boston Keratoprosthesis type I and underlying auto-immune disease.~   "
110125|NCT02126007|"~     This randomized clinical trial (RCT) pilot study as two main objectives:~        -  determine the overall feasibility of a behavioral intervention for managing fatigue~          among older adults with HIV infection.~        -  to estimate effect sizes for group differences at 1, 2, and 3 months on five dimensions~          of fatigue.~      The investigators hypothesize that adherence, satisfaction, and attrition will be similar for~     the active intervention group and the attention control group. The investigators also~     hypothesize that all five dimensions will improve in the intervention group compared to~     controls over time, and that Cohen's d (Standard Deviation units) will be greater than 0.5 SD~     units for all five fatigue dimensions at all three post-intervention time points.~   "
110126|NCT02125994|"~     It is established that the local anesthetic that is administered during an interscalene block~     affects the autonomic outflow to the heart. This is very well seen during shoulder surgery~     when the patient is positioned in beach chair pasition.~      The investigators want to study the different effect of the two concentrations (0.5% and~     0.375%) of ropivacaine on the autonomic nervous system through blood pressure and heart rate~     measurements.~   "
110127|NCT02125981|"~     The limaprost alfadex can improve the surgical outcomes in patients with cervical myelopathy.~   "
110128|NCT02125968|"~     The purpose of this study is to investigate the video game play therapy in patients with~     chronic low back pain.~   "
110129|NCT02125955|"~     Currently, over one third of Canadian children and youth aged five to seventeen are~     overweight or obese. Childhood obesity leads to increased risks of co-morbidities such as~     type 2 diabetes, fatty liver disease, cardiovascular disease and certain types of cancers.~     Changes in the food supply have been linked to obesity and include a decrease in the intake~     of dietary fiber. Prebiotic fibers are a group of non-digestible carbohydrates that modulate~     the composition and actions of the gut microbiota and have been shown to reduce body fat and~     energy intake in overweight and obese adults. The investigators hypothesis is that prebiotic~     fiber intake in overweight and obese children will similarly result in improvements in body~     composition and reduced energy intake.~   "
110211|NCT02124889|"~     Additional micronutrient supplementation is required due to the changes in the~     gastrointestinal anatomy and physiology following bariatric surgery along with decreased~     dietary intake and rapid weight loss. Good adherence to post-operative vitamins is essential~     to maintain healthy vitamin levels in the body following bariatric surgery. The hypothesis of~     this study is that patients receiving a weekly survey intervention will have better adherence~     to post-operative vitamins than a control group not receiving the survey.~   "
110130|NCT02125942|"~     Borderline personality disorder is a severe psychiatric disorder marked by emotional~     instability, difficulty with interpersonal relationships, and self-harming behaviors. Despite~     receiving psychotherapy for borderline personality disorder, studies show that patient~     recovery is slow, and there is a high rate of self injury and suicide attempts early in~     treatment. There is thus a clear need to provide therapies to augment psychotherapy. We will~     conduct a pilot trial to determine whether a 6-week Central Meditation and Imagery Therapy~     (CMIT) is feasible for subjects with borderline personality disorder to undergo when added on~     to psychotherapy treatment. CMIT is a non-validated therapy that combines principles of~     mindfulness with meditation techniques and guided imagery. Sessions led by a trained~     clinician in a group setting once a week, and participants are asked to complete daily home~     practice.~      The trial will involve 16 participants, all currently undergoing psychotherapy for borderline~     personality disorder. Participants will be randomly assigned to either a CMIT group that~     lasts 6 weeks, or a wait list group. Those in the wait list group will be able to receive~     CMIT after 6 weeks. All participants will continue to receive psychotherapy throughout the~     trial.~      During the trial, we will also obtain preliminary data to help understand whether CMIT may~     result in psychological benefits for participants. This will include measuring the pulse in~     order to determine variation in beat to beat intervals of the heart during psychological~     tests, and filling out questionnaires before and after participation in CMIT.~   "
110131|NCT02125929|"~     To determine the efficacy and safety of robotic, laparoscopic and open surgery for~     enucleation of benign pancreatic neuroendocrine tumors~   "
110132|NCT02125916|"~     The objective is to study the cognitive functions in patients with chronic obstructive lung~     disease (COLD) and patients with interstitial lung disease (ILD) compared to healthy~     controls. The cognitive functions are tested with and without oxygen therapy to clarify the~     effect of oxygen therapy. Driving simulations is used to test the cognitive functions.~      The hypothesis is that patients with chronic lung disease have decreased cognitive functions~     and that oxygen therapy will increase their cognitive functions.~   "
110133|NCT02125903|"~     The blockade of the femoral nerve (FNB) is the most common postoperative pain therapy after~     total knee replacement. Because of motor-driven weakness of the quadriceps muscle induced by~     femoral nerve block mobilization of Patients is difficult even dangerous (falls) and hospital~     stays are extended.~      An alternative method could be an adductor canal block (ACB). Anatomical studies of the~     adductor canal demonstrated that the adductor canal contains the saphenous nerve, a pure~     sensory nerve for medial and anterior aspects of the knee and the tibia without any motor~     function.~      This prospective, double-blinded, randomized study investigates the effect of FNB and ACB on~     quadriceps motor weakness and analgesia determined by Numeric Rating Scale (NRS).~      We expect the ACB to be superior in muscle strength but equal in pain score. Both groups~     receive an additional anterior sciatic nerve block for complete sensory block of the operated~     knee~   "
110134|NCT02125890|"~     An abdominal aortic aneurysm occurs when the part of the aorta travelling down into the~     abdomen balloons out more than 50%. If caught early, treatments can be used to prevent~     rupture of the aneurysm. However, many of these aneurysms are asymptomatic and go undetected~     until they rupture, causing large amounts of blood to spill into the abdominal cavity and~     typically leads to death, if left untreated. The current mortality rate is between 50 and~     90%. The resources required to treat patients with ruptured aortic aneurysms is quite~     substantial given that they need blood transfusions and can have prolonged hospital stays.~     Patients either undergo a more invasive operative repair, associated with greater blood~     products transfusions and complications, or if relatively stable, undergo a less invasive~     repair with tubes called stents. There is less morbidity associated with the latter,~     endovascular repair. To prevent blood loss in elective surgeries, drugs that promote blood~     clotting are often used. One drug, tranexamic acid , has been shown to reduce blood loss,~     reduce the number of blood transfusions required and improve patient outcomes in elective~     cardiac and orthopaedic surgeries, and more recently, in patients with traumatic hemorrhage.~     However, this drug has not been tested in this particular population. The purpose of this~     pilot project is to evaluate the effectiveness of tranexamic acid in reducing clinically~     significant bleeding in patients with ruptured aortic aneurysms in hospital sites across~     Saskatchewan using a single-group intervention design. The investigators will compare the~     data from patients treated with tranexamic acid to retrospective data from a control group~     that is matched on key variables. The investigators predict that tranexamic acid will result~     in reduced bleeding, reduced need for blood transfusions, less patients that require open~     surgery and improved patient outcomes. The results of this study will help determine if this~     treatment is effective at preventing the death of many people with ruptured abdominal aortic~     aneurysms.~   "
110135|NCT02125877|"~     Assessed the new film-coated tablet formulation to the currently approved dispersible tablet~     formulation with regards to overall safety, Gastrointestinal (GI) tolerability, palatability,~     satisfaction and compliance~   "
110136|NCT02125864|"~     The purpose of this study is to examine the plasma concentration of vascular endothelial~     growth factor (VEGF) after standard treatment with one of the newest growth factor~     inhibitors, aflibercept (Eylea).~      Patients with exudative age-related macular degeneration (AMD) are treated today with~     anti-growth factors (anti-VEGF). Eylea appears to have a longer duration of action in the eye~     and a more powerful effect on the edema in the macula than previously used growth factor~     inhibitors. This means that the disease can be controlled with fewer number of injections~     into the eye and the investigators can therefore reduce the risk of complications associated~     with this type of treatment.~      It is unclear what the plasma VEGF concentration after treatment with Eylea into the eye in~     patients with wet age-related macular degeneration is.~   "
110137|NCT02125851|"~     The purpose of this study is to determine if a xanthan gum or honey based budesonide slurry~     exhibit comparable mucosal contact time to a budesonide/sucralose slurry in healthy adult~     subjects.~   "
110154|NCT02125630|"~     A randomized trial evaluating resection of the primary breast tumor in women presenting with~     de novo stage IV breast cancer with bone metastasis only. Previous reports of carefully~     selected patients presenting with stage IV breast cancer suggest that surgery on the primary~     tumor may result in improved survival, but this remains unproven. The early results of our~     ongoing trial MF07-01 trial (a phase III randomized controlled trial of breast cancer women~     with distant metastases at presentation who receive loco-regional treatment for intact~     primary tumor compared with those who do not receive such treatment) showed that patients~     with bone metastasis only have a trend toward improved survival with initial surgery.~   "
110155|NCT02125617|"~     The purpose of this study is to investigate cleavage products of the urokinase~     plasminogenactivator receptor (uPAR) in plasma from patients with castration resistant~     prostate cancer as a predictive marker of response to abiraterone.~   "
110212|NCT02124876|"~     The purpose of this study is to quantify residual limb fluid volume changes between morning~     and afternoon hours, and to determine if fluid volume change is correlated with activity.~   "
110138|NCT02125838|"~     Laryngeal mask (LM) use in gynecological laparoscopy, contrary to widespread opinion, does~     not increase the incidence of gastric aspiration, the failure of ventilation or the risk of~     pulmonary aspiration . LM is presented as an alternative to endo tracheal tube (ETT) in~     spontaneous or positive pressure ventilation (PPV) . LM has gained widespread popularity in~     England for gynecological laparoscopic procedures. In addition in many previous studies LM~     has been successfully shown to provide appropriate lung ventilation in laparoscopic surgical~     interventions .Miller et al. compared the use of ETT, LM-P laparoscopic gynecological~     interventions and identified advantages to LM use. The most important of these advantages was~     that, contrary to tracheal tube techniques for laparoscopic surgeries, use of supraglottic~     laryngeal devices or neuromuscular blocker agents (NBA) were not required during placement.~     Thus for laparoscopic surgeries, compared with the ETT technique, without the need for~     supraglottic laryngeal devices or muscular relaxants, it is easily placed and reduces the~     time spent in the operating room.~      Our aim; to compare the use of LM-S and ETT without neuromuscular agents for laparoscopic~     gynecological intervention with positive pressure ventilation from a surgical viewpoint and~     in terms of effect on ventilation parameters.~      Secondary aim, comparison of airway morbidity with endotracheal intubation and supraglottic.~   "
110139|NCT02125825|"~     The objective is to assess a compact, portable, wireless movement disorder system with~     continuous monitoring capabilities to detect and quantify the severity of levodopa-induced~     dyskinesia in Parkinson's disease.~   "
110140|NCT02125812|"~     The adjunctive use of systemically administered antibiotics has been shown to provide a~     better clinical outcome, particularly in terms of probing depth (PD) reduction and~     attachment-level gain than SRP in subjects with Aggressive Periodontitis.~      The overall objective of this study is to evaluate the clinical and microbiological efficacy~     of moxifloxacin as an adjunct to scaling and root planing versus scaling and root planing~     over placebo in the treatment of aggressive periodontitis.~   "
110141|NCT02125799|"~     High frequency repetitive transcranial magnetic stimulation (HF-rTMS) has shown safety and~     efficacy for treatment-resistant depression, but requires daily treatment for 4-6 weeks.~     Accelerated HF-TMS (aHF-rTMS), in which all treatments are delivered in less time, would have~     significant advantages in terms of access, patient acceptance and costs. In the present open~     label trial the investigators intend to assess the effectiveness and acceptability of a novel~     aHF-rTMS protocol (i.e., 2 daily sessions over 2 consecutive weeks; 6,000 pulses per day).~     For this, depressed outpatients will receive the aHF-rTMS protocol and will be assessed at~     baseline and at weeks 3 and 9 with several clinician- and patient- reported measures as well~     as with computerized neurocognitive tests.~   "
110142|NCT02125786|"~     The primary purpose of this study is to investigate whether surgery and re-irradiation will~     help treat ependymoma that has come back after initial treatment. The combined doses of the~     first and second courses of radiation are higher than what is usual standard of care. The~     investigators will study the effects and side effects of surgery and re-irradiation. They~     will also evaluate and study tumor tissue and blood to learn more about the tumor and how it~     does or does not respond to treatments and will use magnetic resonance imaging (MRI) and~     positron emission tomography (PET) scans to see if they can predict tumor response and tumor~     recurrence.~      Participants will be followed for up to 5 years following enrollment. Evaluations during~     radiation therapy will be done weekly while receiving therapy for up to 7 weeks. Other~     evaluations will be done at enrollment, every 4 months from enrollment through 3 years, and~     every 6 months during the 4th and 5th year.~   "
110143|NCT02125773|"~     This study is a controlled, un-blinded, two-arm, randomized (1:1) clinical trial to determine~     if providing high-risk subjects with a calculated risk score changes the likelihood of~     pre-exposure prophylaxis (PrEP) uptake.~   "
110144|NCT02125760|"~     This study is divided for development in two complementary work packages justified by the~     need to incorporate new strategies to optimize rehabilitation outcomes in stroke patients.~     The general objectives are: 1) to determine the prevalence of respiratory muscle dysfunction~     in stroke patients; 2) to identify the existence of a potential amino acid marker of~     increased risk of muscle dysfunction after suffering a stroke; 3) to evaluate the~     effectiveness of incorporating the respiratory muscle training as an innovative adjuvant~     therapy in stroke rehabilitation program that may decrease the incidence of morbidity and~     mortality in the medium and long term; and 4) to quantify the potential impact of respiratory~     muscle training on the costs of care for stroke patients.~   "
110145|NCT02125747|"~     The purpose of this study is to determine effectiveness, feasibility and safety/tolerance of~     Respiratory Therapy in hospitalized patients with acute exacerbations of chronic obstructive~     pulmonary disease.~   "
110146|NCT02125734|"~     The study is a multicenter, randomized, 2-period, open-label, two arm, cross-over study to~     show the superior effect of a 4 week treatment each with QVA149 versus tiotropium on lung~     function. Similarly, this study aims to evaluate patient preference after experiencing both~     treatment regimens in patients with a clinical diagnosis of COPD (GOLD 2013) and a moderate~     to severe airflow limitation who are symptomatic (defined as CAT score of at least 10) at~     screening despite being treated with tiotropium~   "
110147|NCT02125721|"~     The purpose of this study is to evaluate the effect of escalating doses of cystine biding~     thiol drugs, including tiopronin and d-penicillamine, on the urinary cystine capacity, which~     is a measure of the amount of cystine in the urine, in patients with cystinuria. The overall~     goal will be to help guide therapy and ultimately minimize unnecessary side effects caused by~     larger doses.~   "
110156|NCT02125604|"~     The primary objective of this study is to evaluate the effect of symptomatic therapies on~     gastrointestinal-related events reported by participants with relapsing-remitting multiple~     sclerosis initiating therapy with BG00012 (dimethyl fumarate, DMF) in the clinical practice~     setting.~      The secondary objectives of this study in this study population are as follows: to evaluate~     gastrointestinal-related events requiring symptomatic therapy and the role of those therapies~     over time; to evaluate gastrointestinal-related events that lead to a physician's decision to~     manage the events with BG00012 dose modification; and to evaluate gastrointestinal-related~     events that lead to BG00012 discontinuation after the use of symptomatic therapy.~   "
110157|NCT02125591|"~     The purpose of this study is to evaluate improvement in balance after receiving physical~     therapy when augmented by CN-NINM than when augmented by a placebo (sham CN-NINM).~   "
110148|NCT02125708|"~     The most common reason for preterm prelabor rupture of membrane (PPROM) is an ascendance of~     infection. Moreover PPROM is one of the main risk factors for chorioamnionitis.~      PPROM-related morbidity and mortality is higher in the neonate than in the mother, especially~     in case of intrauterine inflammation. Of note, the most common biomarkers like CRP and~     leucocytes are not specific for uterine infections and have not been proven useful in these~     particular cases. Studies in intensive care medicine could show that there is a possible~     correlation between onset of infection and body-core-temperature.~      The OvulaRing® is a non-invasive thermometer measuring the intravaginal temperature every 5~     minutes. It was originally invented to assess the moment of ovulation and optimize fertility.~      Twenty patients with verified PPROM between gestation week 22 and 27 should be included in~     this study. After gynecological and physical examination within verification of PPROM women~     will be informed and invited to participate in this study. Subsequently informed consent will~     be obtained and the OvulaRing® placed into the vaginal fornix.~      The investigators aim to describe a possible correlation between core-temperature and common~     biomarkers in clinical use for the detection of chorioamnionitis in patients with PPROM to~     possibly assess the optimal time for delivery subsequently.~   "
110149|NCT02125695|"~     The main objectives of the study are: To determine if RNA recovery from tape harvesting~     allows for the identification of a disease gene signature (e.g., interferon [IFN] signature~     for lupus) or other biomarkers that may differentiate affected from normal or unaffected~     skin; To determine if the lupus gene signature is differentially expressed in the epidermis~     from active discoid lupus erythematosus (DLE) or subacute cutaneous lupus erythematosus~     (SCLE) lesions when compared with unaffected skin from the same participants and from the~     skin of healthy volunteers (HVs); To determine if the atopic dermatitis (AD) gene signature~     is differentially expressed in the epidermis from active AD lesions when compared with~     unaffected skin from the same participants and from the skin of HVs; and To correlate the~     levels of transcripts of targeted genes in the skin by tape harvesting with those obtained~     from the blood.~   "
110150|NCT02125682|"~     Atorvastatin is a statin that significantly decreases LDL level. At 10 mg/day, atorvastatin~     increases HDL level by 4-5%. At 80 mg/day, atorvastatin does not increase HDL level. However,~     atorvastatin is more protective at 80 mg/day than at 10 mg/day. This is due to a better~     reduction in LDL level at 80 mg, but we also think that 80 mg/day of atorvastatin is superior~     to 10 mg/day in improving the QUALITY of HDL, such as improving HDL particle number and~     function (better anti-oxydant activity)~   "
110151|NCT02125669|"~     Pulsed dye laser (PDL) treatments have been suggested to be a safe and effective therapeutic~     approach for treating basal cell carcinomas. Robust supporting evidence is, however, lacking~     due to inconsistent design of available studies. The purpose of this study is to evaluate the~     PDL's efficacy and safety in treating superficial basal cell carcinoma (sBCC) at low risk~     anatomical sites in an evidence based study setting.~   "
110152|NCT02125656|"~     Sleep is an essential biological process for life and great value to functions such as~     learning, memory processing , cell and brain repair. Recently, new evidence points to the~     relationship between lack of sleep and carbohydrate metabolism , establishing a framework for~     insulin resistance observed in studies with restriction and sleep deprivation on several~     nights and in a single night . To reverse this process , one of the most effective strategies~     is physical exercise and part listed in the literature as a non-pharmacological tool for~     prevention and health promotion , as well as in the treatment of some diseases . However ,~     the pace of modern society causes people to practice less physical exercise , lack of time~     being the main reason . In this scenario, the High Intensity Interval Training ( HIIT )~     emerges as a powerful strategy that induces major changes optimizing the time spent on such~     activity. Considering the benefits of this mode , the purpose of this study is to investigate~     the effects of high-intensity interval training in the context of insulin resistance observed~     during sleep deprivation. Will be recruited 20 male volunteers, aged between 18 and 35 years~     old, healthy, with normal sleep duration equivalent to 7-8 hours / night, not smoking and~     regular eating habits. They will be submitted to a protocol of 6 sessions of high-intensity~     interval training for two weeks, and since the end period, sleep normally, or be deprived of~     sleep for 24 hours. Biochemical (thyroid hormones, cortisol, glucagon, free fatty acid,~     cholesterol, glucose and insulin) will be undertaken as well as evaluation of body~     composition by plethysmography, basal metabolic rate by indirect calorimetry and insulin~     sensitivity through Oral Glucose Tolerance Test (OGTT) before and after the training period.~   "
110153|NCT02125643|"~     We have hypothesized: 1) Caffeine will increase maximal voluntary strength compared to~     placebo in undamaged muscle. 2) Caffeine will increase muscle activation compared to placebo~     in undamaged muscle. 3) Caffeine will enhance spinal excitability (indicated by an enhanced~     H-reflex) compared to placebo in undamaged muscle. 4) Caffeine will raise the pressure-pain~     threshold (indicating decreased pain sensitivity) in the calf muscle compared to placebo in~     undamaged muscle. 5) Caffeine will reduce the amount of low-frequency fatigue, indicated by~     an enhanced 20-100 hertz strength ratio, compared to placebo in undamaged muscle. 6) Caffeine~     will increase maximal voluntary strength compared to placebo in damaged muscle. 7) Caffeine~     will increase muscle activation compared to placebo in damaged muscle. 8) Caffeine will~     enhance spinal excitability (indicated by an enhanced H-reflex) compared to placebo in~     damaged muscle. 9) Caffeine will raise the pressure-pain threshold (indicating decreased pain~     sensitivity) in the calf muscle compared to placebo in damaged muscle. 10) Caffeine will~     reduce the amount of low-frequency fatigue, indicated by an enhanced 20-100 hertz strength~     ratio, compared to placebo in damaged muscle.~      The proposed research will determine the effects of a 5mg/kg body weight dose of caffeine on~     muscular strength, activation, H-reflex function, and excitation-contraction coupling before~     and after exercise-induced muscle damage. The long term objectives are to gain a better~     understanding of caffeine and its affects following exercise-induced muscle damage allowing~     us to understand how caffeine is mechanistically interacting with functions of the body.~   "
110158|NCT02125578|"~     The primary objectives are to identify the highest safe and well-tolerated dose and frequency~     of BIIB017 (PEGylated Interferon Beta-1a) subcutaneous (SC), within the range of 63 to 188~     mcg, when given every other week or every 4 weeks to healthy volunteers (HV).~   "
110213|NCT02124863|"~     The purpose of this study is to determine whether Intrapulmonary Percussive Ventilation (~     airway clearance technique) provokes or aggravates gastro-oesophageal reflux in infants from~     0 to 12 months.~   "
110159|NCT02125565|"~     Arterial Blood Gas (ABG) sampling is a common procedure in all hospitals worldwide. Often,~     ABG samples are obtain from inserting a needle into the radial artery at the wrist - this~     procedure is often painful and dreaded by patients. Therefore, some doctors use local~     anaesthetic but others argue that it makes the procedure more difficult and causes pain~     itself. The use of local anaesthetic costs approximately £1 per injection and when thousands~     of ABGs are performed per month, the cost is easily appreciable. However, there is no good~     research to guide clinicians in the use or omission of local anaesthetic for ABGs. This is~     the first randomised clinical trial to assess the efficacy of injected local anaesthetic on~     the perceived pain of radial artery puncture.~   "
110160|NCT02125552|"~     The primary objective is to determine whether the use of ultrasound guidance compared to~     standard IV access improves the proportion of successful IV placement on a first attempt for~     children in a pediatric emergency department who have predicted difficult access by a~     validated score. Secondary objectives include determining whether ultrasound-guided IV access~     lowers the overall number of IV attempts and/or reduces time to IV access. The investigators~     will also examine the duration of IV access and any complications related to IV access in~     both the traditional and ultrasound guided IV access group.~   "
110161|NCT02125539|"~     The purpose of this study is to provide a comprehensive evaluation of the new, Navigating my~     Journey program for adolescents receiving treatment in an outpatient substance abuse center.~      The primary hypotheses are that, relative to the control condition, Navigating my Journey~     will be associated with significantly higher motivation, higher self-efficacy, improved~     relapse coping skills, and lower substance use. The secondary hypotheses are that, relative~     to the control condition, Navigating my Journey will be associated with increased therapeutic~     alliances with counselors.~   "
110162|NCT02125526|"~     Patients presenting with large myocardial infarction and signs of persistent ischemia after~     successful percutaneous coronary intervention, have a poor prognosis with respect to outcome~     and development of heart failure in the future.~      The hypothesis of this study is that in patients in whom persistent ischemia is present, use~     of intra-aortic balloon pump will be beneficial and improve outcome.~   "
110163|NCT02125513|"~     The purpose of this study is to define whether 6 courses of neoadjuvant chemotherapy can lead~     to a higher rate of complete cytoreductive surgery compared with 3 courses of neoadjuvant~     chemotherapy in patients with epithelial ovarian cancer, fallopian tube cancer or primary~     peritoneal cancer.~   "
110164|NCT02125500|"~     Aim of the study is to assess the efficacy and safety of 24 weeks of oral~     Sofosbuvir/Ledipasvir fixed-dose combination (FDC) in subjects with HCV genotype 1 infection~     and HIV co-infection, who have previously failed a NS3/4A protease inhibitor plus Pegylated~     interferon /ribavirin regimen or stopped prematurely their treatment for intolerance.~   "
110165|NCT02125487|"~     The purpose of this study is to determine whether the use of hybrid simulation of the breast~     are more effective in teaching CBE technique and culturally sensitive doctor-patient~     communication skills to medical students than the traditional method.~   "
110166|NCT02125474|"~     Well-differentiated neuroendocrine tumors (WDNETs) are uncommon neoplasms with an increasing~     number of new cases reported in the annual statistics of the Instituto Nacional de~     Cancerología (INC). The majority are advanced-stage presentations with limited chances of a~     complete surgical resection of the primary tumor, a clinical scenario where medical treatment~     options are also limited. In view of the characteristically defined expression of peptide~     receptors in WDNETs, radioactive molecular probes to target specific cellular receptors have~     been designed using radioisotopes with short range of penetration in tissues. We have~     designed a one-arm phase II prospective sequential clinical trial to assess the therapeutic~     efficacy of 177-Lu-[DOTA 0, Tyr 3] octreotate (177-Lu- DOTATATE) applied intravenously in~     three separate doses to patients with inoperable progressive WDNET. Selected patients~     matching inclusion criteria will be enrolled at the INC's Section of Endocrinology. Tumor~     response, treatment safety (side effects) and survival will be appraised. Data from clinical,~     biochemical and imaging follow-up will be periodically registered during treatment and until~     two years after the last infusion of 177Lu- DOTATATE. This phase II trial is justified~     because despite the fact that many preclinical and clinical studies have showed the potential~     usefulness of this novel palliative approach to treat patients with advanced-stage WDNETs~     there is a paucity of vigorous results to establish its efficacy as first-line treatment.~   "
110167|NCT02125461|"~     A Global Study to Assess the Effects of MEDI4736 following concurrent chemoradiation in~     Patients with Stage III Unresectable Non-Small Cell Lung Cancer.~   "
110168|NCT02125448|"~     Rationale: For resectable esophageal cancer the standard therapy is 5 weeks of neoadjuvant~     chemoradiotherapy (nCRT) followed by surgery 6-8 weeks afterwards. Surgery is performed~     independent of the response to nCRT and is associated with substantial morbidity. A~     pathological complete response (pCR) after nCRT is seen in 28-34% of patients. Pathological~     non-responders (pNR) most probably do not benefit from nCRT but are exposed to its toxicity~     and delay from surgical therapy inevitably occurs in this group. Early identification of~     non-responders during nCRT would allow individualized decision making in continuation or~     discontinuation of nCRT. Furthermore, a tool is desirable to accurately assess the treatment~     response after nCRT to identify patients with a complete response. Studies in rectal cancer~     reported that tumor resection could be omitted in patients with persisting clinical complete~     response after 12 months. Also, in some esophageal cancer studies, complete responders in~     surgical and non-surgical treatment groups had comparable overall survival. These findings~     indicate the possibility to perform nCRT as sole treatment in patients with a complete~     response. Conversely, if residual tumor is demonstrated, this will support the decision to~     move to surgery.~      Objective: Diagnostic study to assess the distinct and combined value of anatomical and~     functional magnetic resonance imaging (MRI) and combined 18F-fluorodeoxyglucose positron~     emission tomography and computed tomography (PET-CT) in the evaluation of treatment response~     to nCRT for patients with esophageal cancer.~      Study design: Multi-center diagnostic study investigating the value of MRI and PET-CT in the~     imaging before, during and after nCRT for assessment of response to nCRT for resectable~     esophageal cancer. Imaging response measurements will be compared with the histopathological~     tumor regression grade (TRG) of the resection specimen as gold standard.~      Study population: 50 patients (>18 years) presenting at the UMC Utrecht or M.D. Anderson~     Cancer Center with resectable esophageal cancer, as determined by endoscopy and biopsy,~     computed tomography (CT) and endoscopic ultrasonography (EUS), receiving nCRT prior to~     surgery.~      Procedure: In addition to the conventional diagnostic work-up for esophageal cancer including~     a standard PET-CT before nCRT, two PET-CT scans will be performed during and after nCRT as~     well as three MRI scans before, during and after nCRT at the same time points. The first MRI~     (and standard-of-care PET-CT) scan session will be within the 6 weeks prior to the start of~     nCRT. The second scan session will take place after 10-14 days after the start of nCRT. The~     third and final scan session will be planned 1-2 weeks before surgery.~      Main study parameters/endpoints: Determination of the distinct and combined diagnostic value~     of anatomical and functional MRI and PET-CT in the evaluation of treatment response to nCRT~     for patients with esophageal cancer. Important imaging parameters include apparent diffusion~     coefficient (ADC) values, standardized uptake values (SUV) and volume measurements for the~     different time points. The differences of these values between time points are of particular~     interest (delta-ADC, delta-SUV, delta-volume). The sensitivity (%), specificity (%), negative~     predictive value (%), positive predictive value (%), and accuracy (%) of the different~     imaging parameters for correctly identifying histopathological complete response will be~     calculated.~   "
110169|NCT02125435|"~     The objective of this study is to assess the safety, tolerability, and pharmacokinetics (PK)~     of single ascending intravenous (IV) doses of ASP2408 in non-elderly, healthy male and female~     subjects and to evaluate the pharmacodynamics of ASP2408.~   "
110170|NCT02125422|"~     Transcranial direct current stimulation is a tool to modulate cortical excitability.~   "
110171|NCT02125409|"~     In a preliminary study in healthy subjects, the investigators determined the pharmacokinetic~     and pharmacodynamic of enteric-coated acetylsalicylic acid (ASA) (Adiro 100 mg, Bayer), and~     the variability (coefficient of variation), accuracy and precision of a novel biomarker of~     ASA action, i.e., quantification of the extent of COX-1 acetylation at serine-529, using a~     stable isotope dilution liquid chromatography multiple reaction monitoring/mass spectrometry~     (LC-MS) technique.~      Now, the investigators will perform a clinical study in individuals undergoing Colorectal~     cancer (CRC) to validate the hypothesis that that low-dose ASA given once daily is acting~     primarily by selectively acetylating platelet COX-1 and suppressing its activity throughout~     the 24-hour dosing interval. In contrast, it is expected that the inhibitory effect on~     extra-platelet sources of COX-1 will be short-lasting, if any, affecting only partially~     COX-1, and this effect will be completely reversed at 24 hours after dosing. This is an~     important point which will strengthen the platelet hypothesis underpinning the apparent~     adequacy of a 24-hour dosing interval of ASA administration for the anticancer effect~     detected in cardiovascular trials.~      These patients will be stratified into individuals with adenomas/carcinomas (20 to 30%) and~     patients without clinically detected adenomas/carcinomas (about 70 to 80%).~   "
110232|NCT02124603|"~     The purpose of the present study is to elucidate the spectrum of ocular flora and their~     antimicrobial susceptibility profiles in patients undergoing routine cataract surgery.~   "
110172|NCT02125396|"~     Despite advances in our understanding of hepatocellular carcinoma (HCC) and its diagnosis,~     the prognosis for patients with HCC remains disheartening, due to a high recurrence rate and~     frequent intrahepatic metastasis. Various therapies for use after hepatic resection have been~     reported, but they are associated with adverse side effects or they fail to improve overall~     survival. Nowadays, adjuvant transarterial chemoembolization (TACE) is recommended as the~     most effective therapy for postoperative HCC. And the indication is patients with risk~     factors of recurrence. While more and more prospective studies revealed that radiotherapy is~     effective for advanced HCC. And the side effects of radiotherapy are controlled. Until now,~     no prospective or retrospective study compared the efficacy of adjuvant TACE and radiotherapy~     for postoperative HCC.~   "
110173|NCT02125383|"~     The purpose of this study is to evaluate the effects of transcranial direct current~     stimulation (tDCS) on patients with Parkinson's disease during sleep.~   "
110174|NCT02125370|"~     This study is largely a qualitative study with a small survey component. The aim of the~     survey would be to gain a quantitative perspective of how women use NRT after this has been~     prescribed by stop smoking services (SSS). The aim of the qualitative study would be to~     enhance knowledge of pregnant smoker's views and attitudes about their experiences of using~     NRT and in particular to understand why pregnant women who start using NRT often discontinue~     this early or do not use the medication as it is prescribed. This information is important~     for a number of reasons; firstly it will help health professionals and researchers gain an in~     depth understanding about how women experience using NRT, which may be used to help devise~     strategies for encouraging better adherence and which could be used in future clinical trials~     to gain a clearer understanding as to whether or not NRT is effective in pregnancy.~   "
110175|NCT02125357|"~     This study is being offered to patients who have castrate-resistant (also known as~     hormone-refractory) prostate cancer. The cancer has metastasized or spread outside the~     prostate area to other parts of the body.~      The purpose of this study is to evaluate the effects of sequencing hormonal therapies~     (abiraterone acetate and enzalutamide) and to assess treatment efficacy of these two agents.~   "
110176|NCT02125344|"~     Two regimen are currently considered to have highest efficacy for patients with high-risk~     early stage breast cancer: sequential treatment of high dose epirubicin, taxane, and~     cyclophosphamide concomitantly with a dual HER2-blockade, and weekly treatment with~     paclitaxel/non-pegylated liposomal doxorubicin with dual HER2-blockade or carboplatin. The~     aim of the GeparOcto study is to compare those two regimen/strategies.~      Both regimens are myelosuppressive with a significant incidence of chemotherapy induced~     anaemia.~      The second aim of the GeparOcto study is therefore to compare the use of parental ferric~     carboxymaltose versus physician's choice for the treatment of chemotherapy-induced anemia in~     patients with iron deficiency.~   "
110177|NCT02125331|"~     This study is required to demonstrate that the non-invasive blood pressure (NIBP) measurement~     algorithms on two commercially available multifunction hemodynamic acquisition modules, the~     Patient Data Module (PDM) equipped with the DINAMAP® SUPERSTAT algorithm (PDM-SUPERSTAT)~     and the Patient Side Module (PSM) equipped with Datex-Ohmeda GE algorithm~     (PSM-Datex-Ohmeda), provide accurate NIBP measurements in accordance with the guidelines~     provided by the most recent International Organization for Standardization (ISO)~     81060-2:2013.~      Notably, the new ISO 81060-2:2013 supersedes the previous 2009 version of this standard, and~     this study is being conducted in accordance with the most recent applicable standards.~      This study will assess neonate, infant, children, pediatric, adolescent, and adult patients~     as well as adults with chronic atrial fibrillation in a population that requires non-emergent~     heart catheterization.~      This is a study conducted to satisfy both standards for two NIBP devices and, as such, does~     not require a statistical hypothesis.~   "
110178|NCT02125318|"~     Anagrelide is a drug that has been shown to slow down how fast platelets are made in the bone~     marrow, and has been approved by the FDA for treating high platelets counts in patients with~     bone marrow disorders.~      Anagrelide Controlled Release (CR) is a new preparation of anagrelide that is made to~     dissolve more slowly than currently marketed versions of this drug. Because of this, the~     anagrelide is taken up into the blood more slowly. Researchers think that this slower release~     of the drug could help to lower side effects that might be caused by high blood levels when~     the drug dissolves as quickly as it does with the currently marketed product.~      The main purposes of this study are to see how well Anagrelide CR can control platelet counts~     in patients with high platelet levels, to see what kind of side effects it causes, and to~     measure blood levels of the drug.~   "
110179|NCT02125305|"~     This study aims to investigate the pharmacokinetics/pharmacodynamics metformin IR after oral~     administration in healthy elderly male volunteers.~   "
110180|NCT02125292|"~     The purpose of this study is to compare the palatability of SHP429 capsule contents delivered~     via 3 means of administration (sprinkled on yogurt, sprinkled on applesauce, and emptied into~     a cup and administered with water).~   "
110181|NCT02125279|"~     The objective of this study is to evaluate the safety and efficacy of up to 26 weeks of~     treatment with calcitriol 3 mcg/g ointment when used twice daily, without occlusion, to treat~     pediatric subjects (2 to 16 years and 11 months of age) with mild to moderate plaque~     psoriasis.~   "
110182|NCT02125266|"~     This study is intended to evaluate the safety of V404 PDS in patients with chronic~     non-infectious uveitis. Secondarily, the study will evaluate whether V404 PDS can provide~     clinically measurable benefit over an extended period of time in patients with chronic~     non-infectious uveitis.~   "
110183|NCT02125253|"~     To evaluate the therapeutic equivalence of the lest formulation of Mometasone Furoate Nasal~     Spray, 50 mcg to the marketed formulation NASONEX® (mometasone furoate monohydrate) Nasal~     Spray, 50 mcg/actuation in patients with seasonal allergic rhinitis~   "
110184|NCT02125240|"~     The purpose of this study is to compare 3years of disease-free survival (DFS) of Icotinib and~     placebo in the treatment of patients who EGFR mutation-positive II-IIIA lung adenocarcinoma.~   "
110185|NCT02125227|"~     The objective of this study is to Compare the Safety and the Pharmacokinetic Characteristics~     of the Co-administration of Rosuvastatin and Metformin SR and YH14755 and to Investigate the~     Effect of Food on the Pharmacokinetics of YH14755 in healthy volunteers.~   "
126722|NCT01908777|"~     The purpose of this study is to test the benefit of a chemotherapy drug called romidepsin in~     patients with T Cell Non-Hodgkin Lymphoma (T NHL) who have undergone autologous~     transplantation.~   "
110187|NCT02125201|"~     Neonatal intensive care unit patients undergoes many painful procedures during their~     hospitalization. Effective pain control in such procedures as intubation, catheterization,~     central line insertion, chest tube insertion, etc. is an important part of treatment. Opioids~     administration is a common practice for acute pain prevention. Fentanyl is the preferred~     opioid due to it rapid onset and short duration of action.~      Fentanyl may be given intravenously, transcutaneous transmucosal and intranasal. Intranasal~     administration is practiced for about 20 years. A rich vascular supply in a nose provides~     rapid absorption of the drug. This uninvasive root is now popular for pain prevention and~     treatment. There are about 20 trials with intranasal fentanyl administration to children from~     6 month old to 18 years. The investigators did not find information about this way of~     administration in neonates.~      In our pilot study the investigators want to check if intranasal administration of fentanyl~     is safe and effective in pain prevention in term and preterm neonates during invasive~     procedures and to compare it with intravenous route of administration.~   "
110188|NCT02125188|"~     Bleeding during functional endoscopic sinus surgery (FESS) is a challenge for both surgeons~     and anesthesiologists despite several measures available for improving the surgical field.~     This study was conducted to evaluate the effect of desmopressin on blood loss and the quality~     of the surgical field in FESS.~   "
110189|NCT02125175|"~     High dose radiotherapy is a very effective treatment for prostate cancer. However, there is~     an increased risk of side effects compared to lower dose radiotherapy. This study will~     investigate the use of dose painting radiotherapy. Dose painting radiotherapy administers a~     high dose of radiotherapy to areas of cancer inside the prostate and a lower (standard) dose~     to the rest of the prostate. This may improve control of the cancer without increasing the~     side effects. The radiotherapy is given in 20 doses, called fractions.~   "
110190|NCT02125162|"~     The purpose of the study is to compare how the body takes up and then eliminates the study~     drug BCX4161 when it is taken orally as a hard gelatin capsule and as a soft gelatin capsule.~     This study will also evaluate whether food has any effect on how the body takes up BCX4161.~   "
110191|NCT02125149|"~     The purpose of the study is to determine how a mother's health and physical activity may~     influence her child's growth and development.~   "
110192|NCT02125136|"~     The aim ot the study is to investigate the efficacy and safety of two new intensified~     chemotherapy regimens (gemcitabine (Gem)/nab- paclitaxel (PAC), FOLFIRINOX) as neoadjuvant~     chemotherapy protocol in locally advanced, non-metastatic pancreatic cancer (LAPC) and~     consecutive conversion of the tumor to resectability.~   "
110193|NCT02125123|"~     This study will investigate the effect of an oral nutritional supplement (ONS) along with~     dietary counseling on improving the dietary intake among children with picky eating~     behaviors.~   "
110194|NCT02125110|"~     This project aims at evaluating the consequences of prenatal exposure to neurotoxicants~     (solvents, organophosphate pesticides) on the developing brain, in children aged from 10 to~     12 years.~   "
110195|NCT02125097|"~     The purpose of this clinical investigation is to evaluate the safety and effectiveness of the~     Barrel™ VRD when used to facilitate endovascular coiling of wide-neck bifurcating or branch~     intracranial aneurysms with any approved embolic coils.~   "
110196|NCT02125084|"~     The purpose of this study is to determine the safety and efficacy of a novel combination of~     agents, enzalutamide and everolimus, for the treatment of patients with metastatic~     castrate-resistant prostate cancer who have never received prior chemotherapy, or who have~     previously received docetaxel chemotherapy and have progressive disease.~   "
110197|NCT02125071|"~     An exploratory clinical trial to evaluate the pharmacokinetic characteristics of I.V. Hepabig~     injection used for prevention of hepatitis B relapse after liver transplantation.~   "
110198|NCT02125058|"~     Rationale:~      Skin cancer is common in Caucasians and often exists on sun-exposed areas, such as the face.~     Treatment of choice is mostly excision and result in an irreversible scar. As the incidence~     of skin cancer is rising, also among young people, it is important to obtain a good cosmetic~     outcome after treatment. It is believed that the type of closure of the wound after excision~     can influence the cosmetic result. Currently, primary closure of the excision can occur by~     transcutaneous (TC) or intracutaneous (IC) suturing. Both techniques are widely used among~     dermatologists and plastic surgeons and the choice is mainly dependent on the preference of~     the physician. Research comparing the cosmetic result of both techniques in the craniofacial~     area is lacking.~      Objective:~      Evaluation of the cosmetic result of transcutaneous sutures versus intracutaneous sutures in~     the craniofacial area.~      Study design:~      A randomized controlled single-blinded multi-center trial.~      Study population:~      Patients older than 18 years, with craniofacial skin tumor receiving surgery followed by~     primary closure at the department of Dermatology and Plastic Surgery of the Maastricht~     University Medical Centre, the department of Dermatology of Catharina hospital Eindhoven and~     the department of Plastic surgery of Orbis Medical Centre Sittard.~      Intervention:~      Excision of the tumor followed by IC sutures or TC sutures~      Main study endpoints:~      Cosmetic result measured on the Patient and Observer Scar Assessment Scale (POSAS) by the~     patient and the researcher 12 months after surgery.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness:~      All patients who participate have an indication for excision and will be assigned to one of~     the suture techniques. Both techniques are widely used in the regular patient care.~     Therefore, no extra risks are associated with it.~      Patients will be asked to visit the hospital 3 months and 1 year following treatment, at~     which point a questionnaire will be filled in and the redness of the scar will be measured by~     means of non-invasive techniques. In addition, patients will be asked to apply a sunscreen on~     the scar daily during the first three months of follow-up.~   "
110208|NCT02124928|"~     The aim of this study is to investigate the association of sonographic and histological~     features of the plaque among each other and with biomarkers of cardiovascular risk. The~     predictive value of these factors concerning the long-term clinical outcome after carotid~     endarterectomy will also be assessed. This may help to improve the identification of patients~     with carotid artery stenosis who will benefit most from carotid endarterectomy. The~     investigators major hypothesis is that the morphology of carotid plaques is associated with~     objectifiable sonographic parameters, in particular with the greyscale median. Second, the~     investigators hypothesize that sonographic and histological plaque morphology are associated~     with certain biomarkers of cardiovascular risk. Identification of 'vulnerable plaques' on the~     basis of a peripheral blood draw and a sonographic investigation may enable the treating~     physician to focus resources on patients who will benefit most form therapeutic interventions~     for primary prevention of ischemic stroke.~   "
110209|NCT02124915|"~     The purpose of this study is to investigate how residual limb fluid volume, gait, prosthesis~     use, perceived comfort, and satisfaction with the prosthesis are affected by size of the~     prosthetic socket. Subjects are tested after wearing a nominal socket for 1 month and again~     after wearing a slightly oversized socket for 1 month.~   "
142042|NCT01708057|"~     This study in Chronic Obstructive Pulmonary Disease (COPD) patients will investigate the~     bronchodilatory effect of AZD8683. AZD8683 will be tested versus placebo and an active~     comparator.~   "
110199|NCT02125045|"~     Background. The antioxidant systems are the main endogenous defense against free radicals,~     and glutathione seems to play an important role in this mechanism. Reduced glutathione enters~     into the detoxification processes of endogenous products, such as hydro- and lipoperoxides~     and exogenous compounds such as pollutants, heavy metals and some drugs. Changes in GSH~     homeostasis have been implicated in the etiology and progression of several diseases.~     Supplementation of GSH may improve the endogenous antioxidant defense and may contribute to~     decrease of oxidants tissue damage a pathophysiologic mechanism of many acute and chronic~     diseases.~      However, the efficacy of GSH treatment seems to be closely related to the degree of its~     absorption and to the increase of its concentrations in plasma and cells. Previous studies of~     oral GSH administration in healthy volunteers or in patients failed to find any effect in~     terms of oxidative stress reduction and/or disease improvement because the GSH is quickly~     catabolized by gastrointestinal tract. We have recently observed (preliminary data) that a~     new sublingual formulation of L-GSH (OXITION), produced by PH&T S.r.l., is able to increase~     erythrocyte and plasma GSH levels in healthy volunteers bypassing gastrointestinal barrier.~      Objectives. The primary study objective is to determine whether medium term (4 weeks) of~     sublingual L-GSH supplementation to a population with smoking habit and/or arterial~     hypertension may result in improved endothelial function as assessed by the flow mediated~     dilation (FMD) technique versus placebo. FMD is a surrogate end point validated in the~     literature as prognostic predictor for major cardiovascular events in patients with~     endothelial dysfunction. Secondary study objectives are to determine differences between the~     2 treatment in terms of oxidative stress markers.~      Methods. This is a phase 3, double-blind, randomized, placebo-controlled, cross-over study~     performed in only one centre. Sixteen male subjects, aged ≥ 40 and ≤ 60 years, with smoking~     habit and/or hypertension defined as arterial blood pressure ≥ 140 and/or 90 mmHg or in~     anti-hypertensive treatment, will be enrolled and randomized to receive sublingual L-GSH (100~     mg twice a day) or placebo according to a double-blind cross-over design for 4 weeks with a~     3-week wash-out period between the two treatments. Baseline and at the end of each treatment~     period, FMD assessment and blood samples collection for routine (creatinine, urea, AST, ALT~     GGT, total cholesterol, HDL, LDL, triglycerides, fasting glucose) and specific (aminothiols,~     nitrotyrosine, malondialdehyde, 8-hydroxy-deoxyguanine) biochemical determination will be~     performed.~   "
110200|NCT02125032|"~     The aim of this study, is to determine whether treatment using transcranial low voltage~     pulsed electromagnetic fields (T-PEMF) can reduce the symptoms patients with Parkinson's~     Disease (PD) experience. The symptoms include movement, mentality and the nervous system in~     general.~      Furthermore the purpose of this study is to clarify whether a group of patients with PD, gain~     a statistical improvement in their symptoms when treated with active T-PEMF, compared to a~     group of patients with PD who receive placebo T-PEMF .~   "
110201|NCT02125019|"~     Longitudinal Evaluation of Taxane induced neuropathy in early stage breast cancer.~   "
110202|NCT02125006|"~     Chronic neuropathic pain is a common problem for breast cancer survivors. Even with the best~     medical treatment, some survivors continue to experience disabling pain. It is~     well-established that an interdisciplinary approach is key to the treatment of some types of~     chronic pain, but little research has been done on the effectiveness of interdisciplinary~     treatments for cancer survivors with chronic neuropathic pain. The investigators will~     evaluate the effectiveness of an interdisciplinary approach combining medical treatment and~     mindfulness-based stress reduction (MBSR) to reduce disability and improve quality of life~     among breast cancer survivors with chronic neuropathic pain. The investigators will also~     evaluate the impact of the program on psychological distress, pain cognitions, biomarkers of~     stress and immune function, cognitive function, as well as brain structure and function.~      The investigators will recruit 108 adult women survivors of breast cancer living with chronic~     neuropathic pain. All will have their medical treatment optimized by a pain medicine~     specialist before being randomly assigned to either an 8-week group MBSR program or a~     wait-list. All participants will complete self-report questionnaires, provide a hair sample~     for cortisol measurements and a blood sample to measure several markers of immune function at~     four different time points: before medical treatment, after medical treatment and before~     randomization to MBSR or waiting, after the completion of MBSR as well as at 3-month~     follow-up. A sub-sample will complete a series of tasks while undergoing functional magnetic~     resonance imaging before and after participation in MBSR.~      The primary outcome is pain interference. The investigators will compare the proportion of~     participants who report reduced pain-related disability, as measured by the Brief Pain~     Inventory-Interference Scale, in each group. The primary hypothesis is that at 3-month~     follow-up, there will be at least 30% more responders (≥1.0 decrease in mean Brief Pain~     Inventory Interference score) in the interdisciplinary program in comparison to medical~     treatment alone.~   "
110203|NCT02124993|"~     This is a questionnaire asking about the sleeve gastrectomy surgery and how has it altered~     food preferences before and after surgery.~   "
110204|NCT02124980|"~     If shown to be effective, the Recovery Line would provide an inexpensive, transportable, and~     easy to use treatment to improve substance abuse outcomes for medication assisted treatment.~     Given the high costs of relapse and continued drug use, improvement of treatment outcomes~     would provide substantial health, economic, and societal benefits.~   "
110205|NCT02124967|"~     South Asian (SA) women living in Ontario have a higher risk of developing type 2 diabetes and~     coronary heart disease (CHD) compared to the general population. Various explanations for~     these differences have been established, one of which is based on low levels of physical~     activity in people of SA origin, particularly in Muslim women.~      This pilot trial will test the feasibility, acceptability and effectiveness of a Mosque-based~     exercise and educational intervention designed for SA Muslim women.~        1. What is the feasibility of a mosque-based intervention to promote physical activity that~          is culturally and gender sensitive to South Asian Muslim women?~        2. What is the acceptability of a mosque-based intervention to promote physical activity~          that is culturally and gender sensitive to South Asian Muslim women?~        3. What is the effectiveness of a mosque-based intervention to promote physical activity~          that is culturally and gender sensitive to South Asian Muslim women?~   "
110206|NCT02124954|"~     A study in healthy males to look at how multiple doses of TA-8995 affect blood levels and~     rate of removal of other drugs, using single doses of digoxin and midazolam as examples, to~     see if there are any potential drug interactions that might affect patients in future~     studies. The study will examine whether co-administration of TA-8995 affects the~     pharmacokinetics of digoxin and midazolam measured by area under the curve (AUC).~   "
110207|NCT02124941|"~     Given prior evidence of reduced resting-state glucose uptake in prefrontal cortex (PFC) as~     measured by [18F]-FDG PET (Volkow 1992, 1993) and direct neurometabolic coupling of cortical~     glucose oxidation and glutamate transmission, we hypothesize that [13C]-MRS measures of VTCA~     and VCYC will be reduced in individuals abstinent from cocaine as compared to HCs. We will~     also explicitly explore potential relationships between VCYC and neurocognitive tests of PFC~     function and clinical outcomes (i.e., measures of relapse at 90-days outpatient follow-up).~     In addition to assessing resting-state glucose uptake in the PFC, we will explore whether~     open-label administration of either of three different pharmacological treatments (N-acetyl~     cysteine, riluzole, or pentoxifylline) increases VCYC, in cocaine users (CU) in comparison to~     their abstinence baseline.~   "
110210|NCT02124902|"~     This is a single arm open label phase II study in women with clinical stage 2 or 3 triple~     negative breast cancer to assess the anti-tumor activity (in terms of pathologic complete~     response rate) of neoadjuvant docetaxel in combination with carboplatin. Patient derived~     xenografts will also be developed simultaneously for the purposes of genoproteomic analysis.~   "
142043|NCT01708044|"~     To examine the effects of different fixed pramlintide:insulin dose ratios in subjects with~     type 1 diabetes on postprandial plasma glucose concentrations~   "
110214|NCT02124850|"~     Protocol VRXP-A106 will enroll patients with Stage II-IVA head and neck cancer patients who~     will be treated with surgical resection. Cetuximab and motolimod (Cohort 1); and cetuximab,~     motolimod, and nivolumab (Cohort 2) will be administered for a 3-4 week period before~     surgery. The primary objective of the study is to determine the extent to which the~     administration of neoadjuvant motolimod plus cetuximab and motolimod plus cetuximab and~     nivolumab modulates immune biomarkers (NK, mDC and T cell activation as well as tumor~     infiltration and serum cytokines) in peripheral blood and head and neck cancer tumors. An~     exploratory objective of the study is to assess whether modulation of biomarkers as described~     above can predict anti-tumor response.~   "
110215|NCT02124837|"~     The objective of this research project is to understand and to improve workers´ recovery from~     work stress. Although recovery during lunch breaks is the most common within-workday break,~     it has received only minor research attention. Therefore, we will study whether lunch breaks~     including a relaxation session or exposure to nature have more favorable outcomes than~     usually spent lunch breaks concerning: a) recovery processes, b) health, c) well-being, d)~     job performance and e) creativity. We approach recovery by combining the theoretical~     frameworks of work and environmental psychology.~   "
110216|NCT02124824|"~     Heart disease is the leading cause of death in the United States, accounting for one in every~     four deaths in 2010 and costing over $300 billion annually in health care, medication, and~     lost productivity. Heart failure (HF), a clinical syndrome that develops as a consequence of~     heart disease, is characterized by the worsening of symptoms, such as dyspnea and fatigue,~     upon exertion, collectively defined as exercise intolerance. Surprisingly, exercise~     intolerance does not correlate with the degree of cardiac contractile (ventricular)~     dysfunction, suggesting that changes in the peripheral circulation may be to blame for~     exercise intolerance in this cohort. Though there are a host of factors that may contribute~     to this impairment, disease-related increases in circulating endothelin-1 (ET-1) may be a~     significant factor in the sequelae of exercise intolerance in HF. Thus, the overall purpose~     of this Small Projects in Rehabilitation Research (SPiRE) proposal is to explore the~     contribution of ET-1 to chronic vasoconstriction in HF patients, and to examine whether~     inhibition of this pathway could improve vasodilatory ability, and thus exercise tolerance,~     in Veterans with HF.~   "
110217|NCT02124811|"~     Schizophrenia is a major mental illness characterized by a variety of different symptoms~     including hallucinations, paranoia, difficulties with formulating and expressing thoughts,~     feelings similar to depression, and problems with cognitive processes. Individuals with~     schizophrenia are usually treated with a class of medications called anti-psychotics, which~     typically help alleviate some of the symptoms of the disorder. In general, anti-psychotic~     medications do not completely cure the disorder, and many patients are left with some degree~     of ongoing symptoms. Furthermore, it is estimated that 20-30% of individuals with~     schizophrenia are considered treatment refractory or resistant and do not respond to~     anti-psychotic medications. The Food and Drug Administration has approved one antipsychotic~     medication for use in patients who are considered to have treatment resistant schizophrenia~     (TRS). This medication, clozapine, has been shown to be beneficial for patients with TRS,~     though as many as 40-70% of patients fail to respond or are partially responsive to treatment~     with clozapine. In an extensive search of the medical and psychiatric literature, we have~     been impressed by the potential of minocycline, a tetracycline antibiotic, as an adjunctive~     therapy in patients with schizophrenia based on its reported neuroprotective and~     anti-inflammatory effects. It is a fairly inexpensive drug, well tolerated, and two~     randomized clinical trials have demonstrated favorable results in early-phase schizophrenia.~     Only one case series with two patients has investigated minocycline in patients with~     schizophrenia on clozapine. Minocycline is also an interesting medication for augmentation~     with clozapine, as we are interested in previous findings of increased inflammation in the~     brains of patients with schizophrenia and the potential role of inflammation in treatment~     resistant schizophrenia. Though there are many markers of increased inflammation in the~     brain, for this current study, we are interested in a general marker of inflammation called~     C-Reactive Protein (CRP). We hypothesize that some patients may have increased levels of~     inflammation in the brain, as measured by the CRP level (drawn from peripheral blood), and~     that those patients with increased levels of CRP may respond better to augmentation with~     minocycline. The proposed pilot study will compare minocycline augmentation with clozapine in~     individuals with high vs low inflammation as measured by CRP. We hypothesize that minocycline~     will be well tolerated and will result in an improvement in the symptoms of schizophrenia,~     cognition, as well as improve the quality of life for patients preferentially in patients~     with high CRPs. We plan to use a variety of different scales to measure improvement in the~     varying symptoms of schizophrenia as well as cognitive function, which will be administered~     to patients at three week intervals for a total study time of twelve weeks. We hypothesize~     that minocycline could prove to be an effective, well tolerated, and inexpensive medication~     for treatment resistant patients with schizophrenia whom have particular difficulties with~     social interactions, obtaining and maintaining employment, and overall quality of life.~     Furthermore, we hypothesize that the data obtained in this study will contribute to the~     ongoing exploration of the role of inflammation in the brain of patients with schizophrenia~     and help understand and target the role of various inflammatory markers in the~     pathophysiology and treatment of treatment resistant schizophrenia.~   "
110218|NCT02124798|"~     The primary objective of this study is to assess the suitability of the autoinjector for~     self-administration of belimumab by subjects with SLE in real-life conditions. The study will~     assess the use of the autoinjector inside the clinic setting and outside the clinic setting.~     The study will also assess the safety and tolerability of belimumab administered~     subcutaneously (SC) via the autoinjector. Subjects will self-administer belimumab SC into the~     thigh or abdomen using the autoinjector device for 8 weekly doses. Subjects will return for a~     follow-up visit 4 weeks after the last SC dose of belimumab. All injections will be assessed~     by the investigators for success based on direct observation and/or the subject diary. A~     total of 118 subjects (treated with at least one dose of study drug) are planned to be~     enrolled in this study.~   "
110219|NCT02124785|"~     The purpose of this study is to assess the long-term persistence of immunity to hepatitis A~     in adults who were vaccinated 21-25 years earlier with hepatitis A vaccine, Havrix®.~   "
110220|NCT02124772|"~     This is a 4-part (Part A, Part B, Part C and Part D), Phase I/IIa, multi-center, open label,~     study in pediatric subjects with refractory or recurrent tumors. Part A is a repeat dose,~     dose escalation monotherapy study that will identify the recommended phase II dose (RP2D) on~     the continuous dosing schedule using a 3 + 3 dose- escalation procedure. Part B will evaluate~     the preliminary activity of trametinib monotherapy in 4 disease-specific cohorts of subjects.~     Each cohort will enroll at least 10 response-evaluable subjects (evaluable for response is~     defined as a subject with a pre-dose and at least 1 post-dose disease assessment or clinical~     assessment of progression of disease). Part C is will be a 3+3 study design to determine the~     safety, tolerability and preliminary activity of the RP2D of trametinib in combination with a~     limited dose escalation of dabrafenib. Part C will enroll up to 24 subjects. Part D will~     evaluate the preliminary activity of trametinib in combination with dabrafenib in 2~     disease-specific cohorts of subjects diagnosed with LGG and LCH. LGG cohort will enroll~     approximately 20 response-evaluable subjects and the LCH cohort will enroll approximately 10~     response-evaluable subjects. The overall goal of this trial is to efficiently establish safe,~     pharmacologically relevant dose of trametinib monotherapy and trametinib in combination with~     dabrafenib in infants, children and adolescents and determine preliminary activity of~     trametinib monotherapy and trametinib in combination with dabrafenib in selected recurrent,~     refractory or unresectable childhood tumors.~   "
110221|NCT02124759|"~     The purpose of this study is to determine the effect of high fat consumption on the~     intestinal microbiome, metabolic endotoxemia, and insulin action, in lean normal glucose~     tolerant subjects.~   "
110222|NCT02124746|"~     This open-label study is to determine the long-term safety and tolerability of momelotinib in~     previously enrolled study participants with primary myelofibrosis (PMF), post-polycythemia~     vera myelofibrosis (post-PV MF), post-essential thrombocythemia myelofibrosis (post-ET MF),~     polycythemia vera (PV), or essential thrombocythemia (ET), who have tolerated and achieved~     stable disease or better with momelotinib treatment while enrolled in a previous clinical~     trial.~   "
110223|NCT02124733|"~     This study is being done to compare a new, continuous illumination regimen of ALA-PDT~     (Aminolevulinate-Photodynamic Therapy) to a conventional regimen for treatment of actinic~     keratoses. The hypothesis is that the continuous illumination approach will be less painful,~     but equally efficacious, as the old regimen.~   "
110224|NCT02124720|"~     Nearly all children with autism spectrum disorders engage in non-functional repetitive vocal~     and motor behaviours commonly referred to as stereotypy. These repetitive behaviours may~     considerably interfere with the child's daily functioning, learning, and social inclusion. As~     such, stereotypy generally has a negative impact on the child and family's health and quality~     of life. Several behavioural interventions have been developed to reduce engagement in~     stereotypy in children with autism spectrum disorders, but the limited number of specialists~     available, the long waiting lists associated with public health services in Canada, and the~     high costs of private services have considerably restricted accessibility. One potential~     solution to the limited availability and high costs of services is using a mobile application~     to recommend, teach, and monitor interventions designed to reduce engagement in stereotypy.~     To this end, the purpose of the study is to evaluate the effects of the iSTIM (i.e.,~     individualized Stereotypy Treatment Integrated Modules), a mobile application designed to~     assist parents in reducing stereotypy in children with autism spectrum disorders.~     Specifically, we will assess whether the iSTIM correctly estimates the frequency or duration~     of stereotypy, offers suggestions consistent with recommended clinical practices, effectively~     reduces engagement in stereotypy, and is socially acceptable, safe, and easy to use for~     parents of children with autism spectrum disorders. The results of the study will allow us to~     determine whether the mobile application may be used to treat this core symptom in children~     with autism spectrum disorders, which could potentially reduce waiting times and costs of~     providing health services to this population. By reducing engagement in stereotypy, the iSTIM~     may also promote and facilitate the social participation as well as improve the quality of~     life and health of children with autism spectrum disorders and their families.~   "
110225|NCT02124707|"~     This is a non-randomized, open-label phase II trial of 38 patients with recurrent or~     metastatic SCCHN. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance~     status of 0-1 with good organ function and will be treated with six weekly cycles of~     carboplatin, paclitaxel and cetuximab. Following assessment of response, the treating~     physician at their discretion may continue to treat with weekly cetuximab as maintenance~     until disease progression. The study is designed to evaluate whether this regimen improves~     median overall survival (OS) as compared to an historical control population treated with a~     platinum plus 5-fluorouracil (5-FU). There is currently no agreed upon first line therapy for~     recurrent or metastatic SCCHN; regimen options are highly toxic, inconvenient and resource~     intensive. Our study regimen has been used extensively for induction therapy and off-protocol~     in palliative care, but treatment outcomes have yet to be defined by a clinical trial.~   "
110226|NCT02124694|"~     This study will pilot an intervention that combines group Interpersonal Psychotherapy (IPT),~     an empirically-supported treatment, and the Historical Trauma and Unresolved Grief~     Intervention (HTUG), a Tribal Best Practice for American Indians. HTUG focuses on grief,~     depression, and trauma response resolution related to collective massive group trauma across~     generations, including the lifespan, for American Indians. We anticipate more positive~     responses to, and patient engagement in, the combined HTUG/IPT intervention than to IPT Only.~   "
110227|NCT02124681|"~     Current options to treat insulin resistance in diabetes are fairly limited. For this reason,~     novel treatments would represent a major progress. The generic drug hydroxychloroquine (HCQ)~     has poorly understood effects on blood sugar metabolism. In this study, the investigators~     will examine the mechanisms by which this drug affects glucose metabolism and which cells are~     affected. Findings emanating from this project will help establish whether HCQ may be a~     viable treatment for disorders of glucose metabolism.~   "
110228|NCT02124668|"~     The purpose of this study is to monitor the safety of enzalutamide in patients with~     progressive castration-resistant prostate cancer previously treated with docetaxel-based~     chemotherapy.~   "
110229|NCT02124655|"~     The accumulation and maturation of oral biofilm in the gingival margin is widely recognised~     to be the primary aetiological factor in the development of chronic gingivitis. Based on this~     association, the current treatment of gingivitis is focused on biofilm disruption, which will~     normally include mechanical processes, both professionally and at home. However, for~     patients, it is not easy to achieve a proper level of plaque control. The efficient plaque~     control techniques are very time consuming and require a special motivation and skills for~     their optimum use. It was at this point where mouthwashes become important, due to the fact~     that they include diverse types of antimicrobial agents to complement the results of~     mechanical oral hygiene measures.~      Chlorhexidine is considered the gold standard of oral antiseptics; nevertheless it has not~     been recommended for long periods of time due to its well-known secondary effects. All of~     these inconveniences have limited its acceptability among dental professionals and users; in~     contrast, however, are the exceptional antiseptic properties, promoting the interest of~     researchers in other alternative antiplaque agents. Mouthwashes containing essential oils in~     their formulation have received a lot of attention. Their antiplaque activity has been~     demonstrated in numerous clinical studies, in which they were used in conjunction with~     mechanical oral hygiene measures.~      In order to achieve a better understanding of the clinical effects that antimicrobial agents~     produce in the interior of the biofilm, it is necessary to apply a methodology in which the~     biofilm grows directly in the interior of the oral cavity but its three dimensional structure~     is not distorted by manipulation.~      The aim of this study was to evaluate the in situ antiplaque effect of 2 antimicrobial agents~     (essential oils formulation and 0.2% chlorhexidine) in the short term with a posterior~     analysis on non-destructured biofilm with Confocal Laser Scanning Microscope combined with~     fluorescence staining.~   "
110230|NCT02124642|"~     The proposed study is a double-blind randomized controlled trial in healthy pregnant women~     (BMI 18.5 - 29.9 kg/m2, age 18 - 40 yr) receiving prenatal care at Athens Regional Midwifery~     clinic (ARMC).~      The primary goal of the proposed study is to determine relative changes in blood folate and~     DNA methylation levels in response to 2 different supplemental doses of folic acid one of~     which will provide the Institute of Medicine's recommended folate intake for pregnant women~     and the second will provide a higher dose as routinely taken by pregnant women in~     over-the-counter prenatal supplements.~      The specific aims of the study are:~        1. to compare maternal serum and red blood cell (RBC) folate levels and % change in women~          taking either 400 or 800 mcg/day of supplemental folic acid from the first prenatal~          visit (< 10 weeks) through delivery;~        2. to compare the infant's cord blood folate levels in response to different maternal folic~          acid intakes (400 mcg/d vs 800 mcg/d);~        3. to determine relative differences in the levels of oxidized folic acid in maternal and~          infant blood in response to 400 or 800 mcg/d folic acid dose, and~        4. to determine genome wide and gene specific DNA methylation response in pregnant women~          receiving prenatal supplements containing either 400 or 800 mcg folic acid per day~   "
110231|NCT02124616|"~     Our aim is to establish multi-center national Egyptian database of information for inherited~     and acquired neuromuscular diseases in infants and children from 0 to 18 years of age.~   "
110233|NCT02124590|"~     This is a longitudinal study supported by Pfizer and is a collaboration between DMPI (Duke~     Molecular Physiology Institute) and DIAL (Duke Image Acquisition Laboratory) to measure the~     effects of acute exercise on carnitine and acylcarnitine levels in the muscle and on insulin~     sensitivity in the plasma. This pilot study seeks to explain why moderate intensity exercise~     provides more improvements in glucose control for pre-diabetic patients than vigorous~     intensity. The investigators hypothesize that moderate intensity exercise might be beneficial~     for elderly individuals who are overweight or obese, specifically by: 1. Reducing damaging~     excess protein acetylation (measured in muscle biopsy), 2. Improving the~     acylcarnitine/carnitine ratio (measured by MRS), 3. Improving overall mitochondrial function~     as reflected in reduced phosphocreatine recovery time (measured by MRS) and 4. Increasing~     insulin sensitivity as measured by a 4-hour oral glucose tolerance test. Investigators intend~     to use the results of this study to show feasibility in measuring mitochondrial function at~     Duke for a larger federal grant submission. Investigators hypothesize that carnitine~     insufficiency might contribute to mitochondrial dysfunction and obesity-related impairments~     in glucose tolerance and insulin action.~   "
110234|NCT02124577|"~     This is a small preliminary study conducted to explore new methods for the potential of~     aiding in diagnosis of liver fibrotic disease as well as predicting disease progression.~     There will be a total of 4 visits spread out over approximately 8 weeks. You will be asked to~     drink heavy water during most of that time. Heavy Water also known as deuterated water,~     is physically and chemically very similar to ordinary drinking water. It tastes and feels~     exactly like regular water. It is odorless and has no known harmful effects at the doses~     given here. Heavy water occurs naturally, and is a minor component of the water we all ingest~     daily.~   "
110235|NCT02124564|"~     This study is to evaluate the long-term safety and tolerability of Lacosamide (LCM) 200~     mg/day to LCM 600 mg/day taken in monotherapy in Japanese subjects who currently have~     partial-onset seizures with or without secondary generalization and who are treated with a~     single Anti-Epileptic Drug (AED) with marketing approval in Japan.~   "
110236|NCT02124551|"~     The purpose of this study is to assess the suitability of the ear and forehead as a better~     site for measure of fluid responsiveness.~   "
110237|NCT02124525|"~     The purpose of this study is to investigate the efficacy of N-acetylcysteine (NAC) for~     smoking cessation in a double blind, randomized, placebo-controlled trial. Simultaneously,~     the study aims to elucidate the role of inflammatory markers and oxidative stress related to~     nicotine addiction and the use of NAC, an acetylated precursor of cysteine, a naturally~     occurring amino acid that has antioxidant actions in its own right, in reducing oxidative~     stress and inflammation in smokers. It will evaluate the use of NAC in smoking cessation,~     after 4, 8 and 12 weeks of treatment.~   "
110238|NCT02124512|"~     Metabolic syndrome is a condition involving elevated levels of fat in the blood, a tendency~     towards diabetes, hypertension, and too much fat around the abdomen (an increased waistline).~     Individuals with metabolic syndrome often have impaired glucose tolerance, which is a~     condition where blood sugar is normal when fasting (before eating), but is too high after~     drinking a sugary drink. This is due to an abnormality in the body's sensitivity to insulin~     (insulin resistance), which is due in part to an inability of the muscle to take up glucose.~      People with metabolic syndrome have inflammation in their fat tissue and in their blood~     stream, and the changes in the level of inflammatory chemicals produced by cells in your fat~     tissues will be studied. One possible source of the inflammation may be the bacteria in the~     intestine. When individuals eat fatty foods, some of the bacterial products become attached~     to the fat in their blood and then get directed to fat tissue. The investigators wish to~     determine whether individuals have an excessive amount of inflammation in their fat tissues,~     and whether this inflammation comes from the bacteria in their intestines. To determine this,~     the investigators wish to treat individuals with an antibiotic that reduces the bacteria in~     their intestines and in their blood, and determine whether this reduces their overall level~     of inflammation.~   "
110239|NCT02124499|"~     Prospective association study to analyse perioperative patients' outcome. Outcome comprises~     intraoperative and postoperative complications e.g. cardio-vascular events, allergic~     reactions, Possible variables which might have on influence: patient- and surgery-related~     data, patients' genetic background etc.~   "
110240|NCT02124486|"~     Idiopathic intracranial hypertension (IIH) is a condition with an unknown cause or causes.~     The condition is associated with raised pressure in the brain and can cause disabling daily~     headaches and loss of sight, which can be permanent. The raised brain pressure squashes the~     nerves supplying the eye (also known as papilloedema) and this can affect vision. Over 90% of~     patients with IIH are overweight and weight loss is the most effective treatment. Other~     treatments for IIH have very little current evidence to support their use.~      Weight loss is difficult to maintain. This trial aims to compare two methods of weight loss,~     bariatric surgery and the most effective dietary programme commonly available, Weight~     Watchers, to see which offers the most effective sustainable treatment for IIH. Bariatric~     surgery is recommended by the NICE clinical guidelines for patients with a Body Mass Index~     (BMI) of over 40, or over 35 with a co-morbidity. Women suffering from IIH have a BMI on~     average around 38 and IIH is not recognised as a co-morbidity for bariatric surgery.~      This trial will recruit 64 women with IIH from Neurology and Ophthalmology clinics in UK NHS~     Trusts. They will be randomised and 32 participants will be allocated to the dietetic~     intervention arm, and be enrolled in their local Weight Watchers group. 32 participants will~     be allocated to the bariatric surgery arm, and will be referred to their local bariatric~     surgery pathway to receive bariatric surgery. Both groups of participants will be allocated~     to a treatment arm which is proven to bring about weight loss.~      Participants will then be followed up for five years, with the most important measurement~     being their brain pressure after one year of being in the trial.~      A further 20 obese women who don't suffer from IIH will be recruited to compare the baseline~     symptoms and biomarkers of those with IIH; they will take no further part in the study. 5~     further healthy individuals will be scanned twice in an MRI test group to validate the MRI~     scan sequence to be used in the trial.~   "
110241|NCT02124473|"~     Resistant hypertension (RHTN) is a common clinical problem faced by both primary care~     clinicians and specialists worldwide. Patients with RHTN have higher rates of cardiovascular~     events and mortality compared with patients with more easily controlled hypertension. In~     addition, RHTN is often complicated by metabolic abnormalities.~      Homeopathy, although widely used in hypertension, but no study has been taken to evaluate the~     impact on resistant hypertension. The aim of this trial was to evaluate individualized~     homeopathy on BP in patients with resistant hypertension.~   "
110253|NCT02124317|"~     The purpose of this study is to determine the efficacy and safety of nanoparticle~     albumin-bound paclitaxel (nab-paclitaxel) plus S-1 as first-line treatment in Chinese~     patients with advanced pancreatic ductal adenocarcinoma (PDA).~   "
113077|NCT02087371|"~     This is a prospective, multicenter, non-interventional, observational study of a cohort with~     a biological plasma and urine samples collection for the study of prognosis factors of~     cardiac complications after liver transplantation~   "
110242|NCT02124460|"~     Health care system (HCS)-based interventions have been limited by their inattention to social~     and environmental barriers that impede improvement in obesity-related behaviors.~     Additionally, current pediatric obesity care delivery relies on an outdated provider:patient~     paradigm which is ill-suited for a problem as prevalent as obesity. HCSs often lack the~     organizational structure to provide longitudinal care for children with chronic illnesses,~     the clinicians to manage and support patients with chronic illnesses outside of clinic,~     and/or the health information systems that support the use of evidence-based practices at the~     point-of-care. Thus, the research question this study is designed to address is whether a~     novel approach to care delivery that leverages delivery system and community resources and~     addresses socio-contextual factors will improve family-centered childhood obesity outcomes.~      The primary specific aims are to examine the extent to which the intervention, compared to~     the control condition, results in:~        1. A smaller age-associated increase in BMI over a 12-month period.~        2. Improved parental and child ratings of pediatric health-related quality of life.~      The secondary aims are:~        1. To examine parental ratings of quality and family-centeredness of pediatric obesity care~          and compare outcomes among participants in the intervention with the control condition~        2. To assess change in weight-related behaviors and compare outcomes among participants in~          the intervention with the control condition~        3. To assess the following process measures:~             -  Reach~             -  Extent of implementation~             -  Fidelity to protocol~             -  Parent satisfaction~        4. To examine the extent to which neighborhood environments modify observed intervention~          effects~        5. To assess the documentation of Healthcare Effectiveness Data and Information Set (HEDIS)~          measures in participant medical records~   "
110243|NCT02124447|"~     This will be a 4-way comparison to prospectively evaluate the efficacy and patient~     tolerability of four commercially available bowel preparations among patients undergoing~     colonoscopy for screening and surveillance in a single tertiary academic medical center.~   "
110244|NCT02124434|"~     Surgery is considered the best therapy for morbid obesity and its comorbidities, where~     alterations in lifestyle, diets and drugs have failed to achieve weight loss. The most widely~     performed in Israel is Laparoscopic Sleeve Gastrectomy (LSG), and several studies have~     reported high success rates in reducing weight and improving comorbidities common among obese~     patients such as hypertension; diabetes mellitus type II; dyslipidemia; osteoarthritis;~     obstructive sleep apnea etc.~      The hypothesis of this prospective study is that the LSG is an effective treatment for~     achieving weight loss, for improving and even curing comorbidities and for improving the~     patient's QOL. Another supposition is that patient's socio-economic status can influence~     success rates of bariatric procedures.~   "
110245|NCT02124421|"~     Community hospital based phase II (prospective randomized) study to evaluate the toxicity of~     cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in newly~     diagnosed, otherwise untreated, advanced stage (stage III/IV) epithelial ovarian, fallopian~     tube, and primary peritoneal cancer.~   "
110246|NCT02124408|"~     With the development of economy and change of lifestyles, it is characterized that there is a~     dramatic increase of diabetes in China. Changes in lifestyle/self-care behaviors by diabetes~     patients are required to improve blood glucose and subsequent outcomes. Mobile phone~     intervention was a kind of high cost efficiency and high quality health care. Our study~     evaluated a diabetes coaching system, using mobile phones and patient/provider portals for~     patient-specific treatment and communication.~   "
110247|NCT02124395|"~     Assessment of Health-related Quality of Life in Rare Kidney Stone Formers in the Rare Kidney~     Stone Consortium~   "
110248|NCT02124382|"~     Evaluate the outcome of pediatric living donor liver transplantation (LDLT) regarding portal~     vein reconstruction, ABO-compatibility and impact of maternal donation on graft acceptance.~   "
110249|NCT02124369|"~     Pancreatic cancer is difficult to treat, and even in a situation where an operation can be~     performed to remove the cancer, the disease can unfortunately come back soon afterwards. When~     pancreatic cancer is more advanced, the outcomes are even less positive. Recently, a large~     international study showed that combining a chemotherapy drug that is standard for treating~     pancreatic cancer, called gemcitabine with a new chemotherapy drug called Abraxane was more~     effective than gemcitabine alone for patients with advanced pancreatic cancer.~      The purpose of this study is to determine whether this combination of gemcitabine and~     Abraxane can shrink a pancreatic cancer that is not thought to be operable enough to enable~     it to be removed by surgery. It is hoped that in this way, the treatment may improve the~     outcome. In addition, in this study we would like to analyse the appearances of the tumour~     using imaging, and collect blood and tumour samples to try to confirm laboratory research~     that has been carried out with this treatment.~   "
110250|NCT02124356|"~     Emergency abdominal surgery is associated with high mortality rates, multiple postoperative~     complications and prolonged duration of hospital admission. The purpose of this study is to~     examine the postoperative functional performance in patients undergoing Emergency High-risk~     Abdominal Surgery. The hypothesis is that the study can describe the patient population in~     relation to postoperative functioning, degree of inactivity and the factors that limit~     mobility.~   "
110251|NCT02124343|"~     Exercise is a cornerstone of pulmonary rehabilitation in the treatment of Chronic Obstructive~     Pulmonary Disease (COPD). Although researchers have shown numerous benefits with exercise in~     COPD patients, most studies have only looked at exercise tolerance and psychological outcomes~     following training. COPD is characterised by persistent inflammation that can cause~     progressive decline in lung function and multisystemic complications. This inflammation can~     be amplified in patients when they suffer acute exacerbations. There is a wellknown~     relationship between exercise, immune function and risk of infection. Exercise has also been~     shown to have an antiinflammatory effect when performed regularly. There is a lack of~     research looking into the inflammatory or immune response to exercise in patients with COPD.~     The exercise within this study will be individually tailored to patients with COPD based on~     their validated 6 minute walk test (6MWT) but the protocol will involve interval exercise~     that has been used previously. This type of exercise is considered most appropriate for~     research into mechanisms of benefit because it maintains the exercise training effects of~     other modalities (e.g. continuous low intensity aerobic exercise) while avoiding the~     occurrence of limitations to exercise in people with lung problems (e.g. dynamic~     hyperinflation). It also closely mirrors daily activity of someone with COPD.~      The investigators want to explore the effects of exercise specifically on immune function in~     15 people COPD and compare any changes to 15 Controls. By better understanding the mechanisms~     of how exercise affects inflammation, the investigators could eventually design better~     Pulmonary Rehabilitation interventions, especially for those most at risk.~   "
110252|NCT02124330|"~     Montmorillonite (MONT) is a phyllosilicate layered mineral with unique physicochemical~     properties, such as swelling and cation exchange capability.~      The aim of this project is to study, in healthy volunteers, the in vivo ability of MONT to~     reduce protein intestinal uptake. Furthermore, the study analyzed in vitro the MONT ability~     of immobilizing proteins.~   "
110254|NCT02124304|"~     Cervical pain is a condition that affects 14.6% of all adults annually. Of this annual~     prevalence, 37.3% experience persistent neck pain with periodic recurring episodes. The~     purpose of this study is to compare muscle activation patterns of the cervical musculature~     during exercises with elastic versus manual resistance in a neck pain and asymptomatic~     populations. Methods: A convenience sample of 15 healthy, physically active participants and~     15 current patients diagnosed with non-radicular cervical pain will be recruited.~     Exclusionary criteria will include: current cervical or upper extremity injury (healthy~     group), history of neck surgery, corticosteroid treatment within the last two weeks, and~     radicular signs or symptoms. Surface electromyography will be used to quantify the activity~     level of the bilateral SCM, AS, Cervical Paraspinal (CP), and the Upper Trapezius (UT)~     muscles while performing a series of 6 exercises with elastic resistance using Thera-Band®~     Resistance Bands and manual resistance. The area will be prepped and surface electrodes~     placed on the corresponding muscles. The movement will be standardized by using the peak~     activation (PA) of each muscle during full flexion-extension movement to create a percentage~     of peak activation (%PA). The testing battery will consist of 6 exercises with elastic~     resistance and manual resistance, totaling 12 different trials. Each trial will involve 5~     repetitions, each held for 5 seconds. The exercises will include cervical: extension,~     flexion, left rotation, right rotation, left side bending, and right side bending. The men~     will use the green and women will use the red Thera-Band® Resistance Band. The order of~     exercises will be randomized in to two parts to minimize the effect of fatigue. First,~     cervical flexion and extension with manual and elastic resistance will be randomized.~     Secondly, the remaining 8 exercises will be randomized. Following each exercise, the patient~     will rate their perceived level of exertion on the Thera-band® Resistance Intensity Scale for~     Exercise (RISE).~   "
110255|NCT02124291|"~     The objective of study is to assess the possible impact of assisted hatching on the~     implantation, pregnancy rate and delivery rate after transfer of vitrified-warmed human~     embryos.~   "
110256|NCT02124278|"~     The purpose is to determine if single doses of PUL-042 inhalation solution are safe in~     healthy subjects.~   "
110257|NCT02124265|"~     In patients with moderate to severe thermal injuries (> 20% TBSA) adequate fluid~     resuscitation is the main priority to achieve successful outcomes. Soon after burn injury~     substantial amounts of fluid accumulate rapidly in the wound while more is lost in the third~     space. Without intervention this process leads to hypotension and shock. The Parkland formula~     was devised to calculate how much intravenous (IV) fluid, i.e. crystalloids, is needed for~     adequate resuscitation during the first 24 hours post-burn. However, IV resuscitation can~     lead to overexpansion of (third space) volume, leading to severe complications such as~     compartment syndrome or pulmonary edema.~      In major population centers, catastrophic events causing mass casualties will disrupt many~     hospital and emergency services, potentially delaying acute IV fluid resuscitation. Burn~     patient case reports have shown that oral rehydration therapy (ORT) used to supplement or in~     place of IV therapy is efficacious. ORT could be easily applied in mass burn casualties.~      ORT is generally known in the third world for treating life-threatening dehydration due to~     diarrhea. The glucose-sodium co transport mechanism enables the affected human intestine to~     absorb a sufficient amount of water and electrolytes to replace large fluid losses due to~     severe diarrhea, even under adverse field conditions. No electrolyte disturbances have been~     recorded in such cases. Studies on enteral resuscitation in animal burn models showed high~     rates of small intestinal absorption which should be adequate for resuscitation following~     major burn injury.~      The optimal composition of oral rehydration solution for resuscitation in burn wounds has not~     been determined. In cholera patients, Ceralyte® has proven superior to the WHO Oral~     Rehydration Solution, increasing fluid absorption of the intestine. The Ceralyte® 90~     solution, with 90mEq/L sodium and a low osmolarity of <275mOsm, may also contribute to~     optimal intestinal fluid uptake without causing electrolyte disturbances in thermal injury.~     ORT use might reduce the occurrence of compartment syndrome and pulmonary edema since fluid~     is regulated by the intestine according to physiologic requirements. The investigators~     propose to conduct a prospective study using Ceralyte® 90 to show that oral resuscitation~     therapy (ORT) in burns can reduce the total amount of IV fluid needed for adequate~     resuscitation and to test the efficacy and safety of ORT in the resuscitation of burn~     patients.~   "
110258|NCT02124252|"~     There are many challenges to implementation of cervical cancer prevention in resource-limited~     countries, despite evidence based screening and treatment strategies. The investigators~     hypothesize that self-collected HPV specimens offered in a community health campaign setting~     will~   "
110259|NCT02124239|"~     This is an open-label, uncontrolled, non-randomised multi-centre trial in which 3 parallel~     groups will be enrolled. The trial includes three active treatment groups.~      To be eligible for inclusion in this trial, subjects must have at least 10 clinically~     typical, visible, and discrete AKs on the face, balding scalp or on the arm within a~     contiguous area of approximately 250 cm2 of sun-damaged skin.~      There will be 3 treatment groups: (1) once daily application of ingenol mebutate gel 0.027%~     on the full face for three consecutive days, (2) the same regimen on the balding scalp, and~     (3) once daily application of ingenol mebutate gel 0.06% on the arm on a treatment area of~     approximately 250 cm2 for four consecutive days.~   "
110260|NCT02124226|"~     Patients with chronic severe asthma (CSA) have a crippling disease and current available~     treatments are not satisfactory. Thus, management of CSA remains a major unmet need. Although~     the evidence from existing randomized controlled trials fails to support a definite role for~     immunomodulatory drugs in these patients due to major methodologic drawbacks, findings with~     low-dose methotrexate (MTX) are encouraging. However, larger and well designed clinical~     trials are required to establish the beneficial role of MTX in CSA and for the detection of~     the key characteristics of those who are going to respond to this drug.~      This study will be the first multi-centre RCT investigating the role of an add-on~     immunological modifier as a clinically useful therapeutic strategy in patients with~     well-phenotyped chronic severe asthma. As such, this study does not overlap with any other~     research currently ongoing.~   "
110261|NCT02124213|"~     This study will evaluate D1 Receptor Occupancy (RO) following a single dose of PF-06412562 In~     healthy male volunteers~   "
110262|NCT02124200|"~     E-cigarettes are proving to be an attractive long-term alternative to conventional~     cigarettes. Although they may also help smokers to remain abstinent during their quit~     attempt, recent clinical trials with first generation e-cigarettes have shown only modest~     quit rates. Second generation devices may result in much higher quit rates. Their efficacy~     and safety in long-term smoking cessation and/or smoking reduction studies have never been~     investigated.~      In this prospective proof-of-concept study we monitored modifications in smoking habits of 50~     regular smokers (unwilling to quit) who were asked to switch to a second generation device~     focusing on smoking reduction and smoking abstinence. Study participants were invited to~     attend a total of five study visits: at baseline, week-4, week-8, week-12 and week-24.~     Product usage, number of cigarettes smoked, and exhaled carbon monoxide (eCO) levels were~     measured at each visit. Smoking reduction and abstinence rates were calculated. Adverse~     events and participants' opinions of these products were also reviewed.~   "
110300|NCT02123693|"~     The aim of the present study is to determine whether there is a relationship between~     osteopathic treatment and the change of physiological axes of the lumbar spine, through the~     use of Dynamic Magnetic Resonance Imaging.~   "
110317|NCT02123472|"~     The purpose of this study is to compare two different preparations of an antibiotic called~     cephalexin to determine if they are essentially the same. The study has two periods.~     Participants will receive one preparation of cephalexin in each period. At least 7 hours will~     pass between the study periods. The study is expected to last about 2 days for each~     participant, not including screening or follow-up.~   "
110263|NCT02124187|"~     It is well established in studies across several countries that tobacco smoking is more~     prevalent among depressed patients than the general population. Electronic cigarettes are~     becoming increasingly popular with smokers worldwide. To date there are no large randomized~     trials of electronic cigarettes in depressed smokers. A well-designed trial is needed to~     compare efficacy and safety of these products in this special population.~      We have designed a randomized controlled trial investigating the efficacy and safety of~     electronic cigarette. The trial will take the form of a prospective 12-month randomized~     clinical study to evaluate smoking reduction, smoking abstinence and adverse events in~     depressed smokers not intending to quit. We will also monitor quality of life, neurocognitive~     functioning and measure participants' perception and satisfaction of the product.~      Outcome measures: A ≥50% reduction in the number of cigarettes/day from baseline, will be~     calculated at each study visit (reducers). Abstinence from smoking will be calculated at~     each study visit (quitters). Smokers who leave the study protocol before its completion and~     will carry out the Early Termination Visit or who will not satisfy the criteria of reducers~     and quitters will be defined non responders.~   "
110264|NCT02124174|"~     Phase II trial combining azacitidine with valproic acid as maintenance therapy post~     allogeneic stem cell transplantation in patients with high-risk MDS/AML. We hypothesize that~     adding valproic acid to azacitidine will improve outcomes via both direct anti-tumor and~     immunologically mediated antitumor response with alloreactive donor lymphocytes, having an~     additive effect and extending 1 year survival in patient with high-risk AML/MDS after~     hematopoietic stem cell transplant. Based on aforementioned data from the US Department of~     Health and Human Services, standard 1 year survival for AML after stem cell transplant is~     near 40%. We hypothesize that valproic acid and azacitidine will prolong survival, with a 1~     year survival goal of 60%. In addition to assessing for 1 year survival, we will have~     secondary objectives of assessing progression-free survival, relapse, and toxicity. The~     primary toxicity endpoint from this will be cytopenias and infections.~   "
110265|NCT02124161|"~     The purpose of this study is to evaluate the immunogenicity and safety of 13-valent~     pneumococcal polysaccharide vaccine when given concomitantly with seasonal inactivated~     influenza vaccine to adults 50 years and older who have previously received 23-valent~     pneumococcal polysaccharide vaccine.~   "
110266|NCT02124148|"~     The main purpose of this study is to investigate the safety of prexasertib in combination~     with other anti-cancer drugs (cisplatin, cetuximab, pemetrexed, fluorouracil or LY3023414) in~     participants with advanced cancer or cancer that has spread to another part of the body. The~     study has multiple parts (A, B, C, D and E). Participants will only enroll in one part.~   "
110267|NCT02124135|"~     Dietary counseling at the point of purchase could improve patient adherence to dietary advice~     and downstream health outcomes. The aim of our pilot is to test the efficacy of a novel~     delivery system for dietary advice. We will study the effect of relocating family weight~     management counseling sessions into restaurants, where registered dieticians and patients~     will conduct scheduled group visits while enjoying a meal together. As with office-based~     visits, our goal is for members and their families to learn how to select food options based~     on their unique health needs, budgetary concerns, and time constraints. In contrast to a~     traditional counseling visit, however, co-dining with a dietitian will give members a~     hands-on experience designed to enhance their learning and improve adherence. The proposed~     study would build on an existing pilot of a similar program, the KP Personal Shopper, where~     dietitian visits were conducted with individuals either in the clinic setting or while~     shopping in a grocery store.~      We will compare the new Eat Out with Kaiser approach to the current standard of~     clinic-based dietary and lifestyle counseling for weight management among 40 families~     affected by obesity, with the following outcomes in mind:~        1. Change in dietary measures~        2. Nutritional knowledge of families~        3. Participant self-efficacy and confidence in food purchasing decisions~        4. Participant and dietician perception of visit~      We hypothesize that, compared to clinic-based visits, our Eat Out with Kaiser visits will~     result in more favorable perception of the visit by both dietitian and participant, higher~     nutritional knowledge scores, higher self-efficacy and confidence of patients around food~     decisions, and larger improvements in diet components.~   "
110268|NCT02124122|"~     This is a Phase 1 study to assess the safety and tolerability of Lactobacillus reuteri (Lr)~     strain DSM 17938 in healthy children in Peru. It is a preliminary study in support of a~     clinical trial to assess safety and efficacy of L. reuteri for treatment of pediatric~     diarrhea in Peru.~   "
110269|NCT02124109|"~     Background:~      - An acquired heart disease is one that a person gets after they are born. Two of these are~     rheumatic heart disease (RHD) and endomyocardial fibrosis (EMF). They are found more commonly~     in people who live in Africa than in other places in the world. Researchers want to learn~     more about these diseases. They especially want to know what role genes and other factors~     play in them.~      Objective:~      - To identify genetic risk factors for RHD and EMF in sub-Saharan Africa.~      Eligibility:~        -  Children and adults with RHD or EMF.~        -  Healthy volunteers over age 10.~      Design:~        -  Participants will come from existing study groups in Uganda and Nigeria.~        -  Participants may be required to provide a sample of their DNA. They will do this with~          either a blood or saliva sample or a swab of the mouth.~        -  Collected samples will be labeled with a code and sent to a lab in the United States for~          analysis. Remaining portions of participants samples will be stored for an unlimited~          period of time. They may be used in future studies.~        -  Some genetic and health information from participants might be placed into one or more~          scientific databases.~        -  Participant names and identifying information will be kept private. But there is a small~          chance someone could trace them from their genetic information.~   "
110313|NCT02123524|"~     This is a Phase III, randomized, placebo controlled, blinded, parallel two arm, multicentre~     trial that will compare rivaroxaban 10mg daily with placebo in patients with symptomatic leg~     Superficial Vein Thrombosis (> or = 5cm) that otherwise would not initially be treated with~     anticoagulant therapy.~   "
110318|NCT02123459|"~     The purpose of this study is to compare two different preparations of an antibiotic called~     cephalexin to determine if they are essentially the same. The study has two periods.~     Participants will receive one preparation of cephalexin in each period. At least 7 hours will~     pass between the study periods. The study is expected to last about 2 days for each~     participant, not including screening or follow-up.~   "
110270|NCT02124096|"~     Background:~      - The flu is a very infectious and contagious virus that affects both people and pigs.~     Studies show that pigs can be sources of the flu virus in humans. Researchers want to know~     more about how the flu is transmitted from animals to people. If they know more about it,~     they can find better ways to prevent the flu and treat people who get sick from it.~      Objective:~      - To discover if flu viruses can be found in people exposed to pigs at Ohio agricultural~     fairs.~      Eligibility:~      - Volunteers 8 years of age and older who exhibit pigs at Ohio agricultural fairs.~      Design:~        -  Before or on the first day of the fair, participants will fill out a short demographic~          and medical history form. They will also complete a two-page symptom questionnaire. This~          is a form that asks them about any flu symptoms they might have.~        -  Participants will have a nasal swab performed. The inside of the participant s nose will~          be rubbed with a swab to collect nasal fluid.~        -  Researchers will see participants 2 days later and 4 days later. During these visits,~          participants will again fill out a symptom questionnaire and have a nasal swab.~   "
110271|NCT02124083|"~     Niemann-Pick disease type C (NPC) is a lethal, autosomal recessive, lysosomal storage~     disorder characterized by neurodegeneration in early childhood and death in adolescence. The~     causative genes NPC1 (about 95% of cases) and NPC2 (about 5% of cases) are involved in the~     intracellular trafficking of lipids and cholesterol. Mutations on either of these genes lead~     to progressive accumulation of unesterified cholesterol and other lipids in the central~     nervous system (CNS). Vorinostat is a histone deacetylase inhibitor that has been shown in~     vivo to increase mutant NPC1 protein levels and to reverse cellular accumulation of~     unesterified cholesterol. Vorinostat has been labeled by the FDA for treatment of cutaneous~     T-cell lymphoma. In this Phase I, non-randomized, open-label, single-center study, we plan to~     study whether Vorinostat can be repurposed to treat patients with NPC1. Our primary objective~     is to determine the safety and tolerability of Vorinostat in NPC1 disease. Our secondary~     objectives will be to determine biochemical efficacy of Vorinostat to increase expression of~     NPC1 protein and normalize lipid and protein biomarkers. This study will enroll up to 12 NPC1~     patients and test the safety of two dose levels (200 and 400 mg). Drug will be administered~     on a 3 days on/4 days off schedule for 3 months at each dose level. Patients will be~     evaluated at the NIH Clinical Center at 0, 3 and 6 months. Safety will be assessed by adverse~     events (AEs), clinical laboratory tests and physical examinations. Biochemical efficacy will~     be assessed by measurement of serum and cerebral spinal fluid biomarkers. Clinical efficacy~     will be evaluated by audiologic testing, assessment ataxia, and swallowing studies.~   "
110272|NCT02124070|"~     Background:~      -(Degree)ystinosis is an inherited disease. If not treated correctly, it can cause muscle~     wasting and weakness and kidney damage. Researchers want to learn if growth hormone (GH) can~     help people with cystinosis.~      Objective:~      - To learn if GH treatment can slow or reverse muscle wasting and improve muscle strength in~     people with cystinosis.~      Eligibility:~      - People 18 and older who are already enrolled in protocol 78-HG-0093.~      Design:~        -  Participants will be admitted to the clinic for eight 3 4 day visits, mostly four months~          apart.~        -  At each visit, participants will have a history and physical exam and give urine and~          blood samples.~        -  At month 0 or 13, participants will take tests that will be repeated at their 12- or~          25-month visit:~        -  They will have an eye exam, medical consultations, and strength and movement tests.~        -  They will complete questionnaires.~        -  They may have tests of heart activity and lung function.~        -  They will have ultrasound imaging of their arm and hand muscles. They will have a scan~          of their legs while lying in a magnetic resonance imaging machine (a big metal~          cylinder). They will have a DEXA bone scan (two X-ray beams measure body composition).~          They will also swallow barium while X-ray imaging records the throat muscles.~        -  Participants will be randomly assigned to either receive or not receive GH for the first~          12 months. Then, at month 13, if they received GH, they will switch for the next 12~          months.~        -  Participants will take GH as a daily injection. They will be taught how to give the~          injections.~   "
110273|NCT02124057|"~     Background:~      - Spinal and bulbar muscular atrophy (SBMA) is an inherited disease. It causes weakness in~     muscles used for swallowing, breathing, and speaking. SBMA mainly affects men, but women can~     carry the gene for it. Researchers think there may be a link between SBMA and excess fat in~     the liver.~      Objective:~      - To look for fatty liver and liver injury in people with SBMA, people with motor neuron~     disease, and people who carry the gene for SBMA.~      Eligibility:~        -  Adults 18 years and older who have SBMA, have motor neuron disease, or are carriers of~          SBMA.~        -  Healthy adult volunteers.~      Design:~        -  Participants will be screened with medical history, physical exam, and blood tests.~        -  Participants will have 1 outpatient visit of 1-2 days. Women will have a urine pregnancy~          test. All participants will have:~        -  Blood tests.~        -  Liver ultrasound. A probe is placed on the abdomen at certain locations and angles and~          takes pictures. The painless procedure takes 20-30 minutes.~        -  Liver magnetic resonance imaging (MRI) scan. The MRI scanner is a metal cylinder with a~          magnetic field. Participants will lie on a table that slides in and out of it. They will~          be in the scanner for about 30 minutes. They will get earplugs for loud noises.~        -  Some participants with abnormal liver testing will have a biopsy (small piece) of the~          liver taken. The biopsy site will be located with ultrasound, then cleaned and numbed.~          The physician will quickly pass a needle in and out of the liver while the participants~          holds their breath. Afterward, participants will be monitored in bed for 6 hours.~        -  Participants may return for follow-up and another 1-2 day outpatient visit yearly for up~          to 2 years.~   "
110314|NCT02123511|"~     This randomized pilot clinical trial studies whether acetylcysteine oral rinse will lessen~     saliva thickness and painful mouth sores in patients with head and neck cancer undergoing~     radiation therapy. Side effects from radiation therapy to the head and neck, such as~     thickened saliva and mouth sores, may interfere with activities of daily living such as~     eating and drinking, and may also cause treatment to be stopped or delayed. Acetylcysteine~     rinse may reduce saliva thickness and mouth sores, and improve quality of life in patients~     with head and neck cancer undergoing radiation therapy.~   "
110315|NCT02123498|"~     The purpose of this study is to investigate the relationship between ear fullness, pressure,~     and/or pain and laryngopharyngeal reflux, in order to focus medical therapy and improve~     therapeutic outcomes in this patient population.~   "
110274|NCT02124044|"~     Chronic hepatitis C virus (HCV) infection is a major public health problem with an estimated~     180 million people infected worldwide. In the United States an estimated 4.1 million people~     are infected and HCV is the principal cause of death from liver disease and leading~     indication for liver transplantation. Within HIV/HCV co-infected patients, liver disease due~     to Hepatitis C progresses even more rapidly. While combination of ribavirin (RBV) and~     pegylated interferon (PEG) in combination with boceprevir/telaprevir is the currently~     recommended therapy for chronic HCV infection and has superior cure rates compared to PEG+RBV~     alone in HCV monoinfected patients, treatment is still associated with a high incidence of~     adverse events (AEs), discontinuations and poor cure rates in several populations. Within the~     HIV/HCV co-infected population treatment for HCV remains complicated given drug interactions~     between anti-retrovirals and HCV protease inhibitors, in addition to the extensive~     side-effects due to PEG +RBV alone. Recent studies have demonstrated that the use of a~     combination of anti-virals which target HCV without interferon (IFN) can cure HCV, without~     additional toxicities. These novel therapies that do not rely on an IFN backbone may~     additionally enhance cure rates in HIV/HCV co-infected, a population which has historically~     been difficult to cure.~      The findings from this study will aid in the understanding of antiviral and host responses~     and determinants of response to an IFN free regimen in HIV/HCV co-infected patients.~   "
110275|NCT02124031|"~     The purpose of this study is to evaluate quality of life, degree of disability, treatment~     patterns and economic impact of hand and knee Osteoarthritis and Rheumatoid Arthritis in~     Mexico.~   "
110276|NCT02124018|"~     The purpose of the study is to assess the prevalence and the prognostic value of non-invasive~     indexes and programmed ventricular stimulation for sudden cardiac death in post-MI patients~     with LVEF >40%.~   "
110277|NCT02124005|"~     The purpose of the study is to determine the minimum effective concentration of bupivacaine~     (EC50) in femoral block for analgesia by ultrasound after knee surgery.~   "
110278|NCT02123992|"~     The aim of this study is to further evaluate the safety and efficacy of the Elevate® Apical~     and Posterior Prolapse Repair System for repair of apical/posterior pelvic organ prolapse in~     a controlled, post-market cohort study.~   "
110279|NCT02123979|"~     Narcotics are widely used as the mainstay of pain treatment, although increasing doses are~     required over time as the individual becomes tolerant to their effects. This can lead to the~     development of dependence and abuse of these drugs. Research has identified a new way to~     decrease the risk of developing tolerance to narcotics, by giving at the same time a drug~     called rotigotine (Neupro). Rotigotine interferes with the body's chemical dopamine and is~     FDA-approved for the management of Parkinson's Disease.~      The purpose of this research study is to look at side effects and pain control in healthy~     people after removal of wisdom teeth, which usually causes pain. It is thought that by giving~     the study drug rotigotine with the narcotic pain reliever, there will be pain control that~     will extend longer than when giving the narcotic alone.~   "
110280|NCT02123966|"~     This research study is evaluating the effectiveness of topical sirolimus combined with~     topical steroid therapy, as a possible treatment for oral cGVHD.~   "
110281|NCT02123953|"~     The purpose of this study was to evaluate the safety and pharmacokinetics of TAK-438~     following multiple oral doses to healthy adult Japanese male participants~   "
110282|NCT02123940|"~     Prospective, randomized clinical multicentric study in ICU during weaning from mechanical~     ventilation.~   "
110283|NCT02123927|"~     The primary purpose of this study was to evaluate the single dose safety and pharmacokinetics~     of TAK-438 in healthy Japanese men.~   "
110284|NCT02123914|"~     1. Moderate exercise training decrease cytokine response and rhinitis symptoms in patients~          with allergic rhinitis~        2. Moderate exercise training combined with vitamin C supplementation decrease cytokine~          response and rhinitis symptoms in patients with allergic rhinitis~        3. Moderate exercise training combined with vitamin C supplementation has more beneficial~          effects than moderate exercise training alone for decreasing cytokine response and~          rhinitis symptoms in patients with allergic rhinitis~   "
110285|NCT02123901|"~     Walking Meditation training would yield more favorable adaptations than walking alone in~     improving glycemic control and vascular function in patients with type 2 diabetes.~   "
110286|NCT02123888|"~     The cone beam image is a part of the radiotherapy treatment machine and uses lower energy~     xrays as the head of the radiotherapy machine moves around the patient in a circle. This~     takes pictures that give 3-dimensional information, somewhat like a CT scan. These images are~     better at showing the position of the tumour and surrounding soft tissues than the standard~     xrays that were previously used. Cone Beam Imaging Technology is not new and has been used~     regularly at The Christie for many years. The standard cone beam scan is taken before the~     actual radiotherapy treatment or after the treatment has been delivered.~      Volumetric Modulated Arc Therapy (VMAT or Arc Radiotherapy) is a novel method of delivering~     radiotherapy that involves the continuous movement of the radiotherapy treatment machine head~     around the patient and MLC during radiation. Arc radiotherapy has been clinically implemented~     at The Christie for prostate radiotherapy treatments and work is in progress for~     implementation in lung radiotherapy. The continuous gantry rotation inherent to VMAT delivery~     makes this simultaneous imaging possible, although there are concerns associated with the~     impact that this may have on patient dose and image quality.~      The aim of this research is to assess whether the image quality of cone beam scans taken~     during treatment are as good as standard cone beam scans taken before or after treatment used~     to determine the accuracy of patient position and the tumour coverage by radiotherapy.~   "
110287|NCT02123875|"~     ATTEND Trial is based on early supported discharge- home based stroke rehabilitation model~     which proves to offer several advantages in low and mid income countries. The objectives of~     the pilot stude were to determine that with a randomized blinded outcome assessor, controlled~     trial, family- led caregiver- delivered home based rehabilitation is better than usual care~     for those with disabling stroke in India and the feasibility of this model.~   "
110316|NCT02123485|"~     The aim of the present study is to investigate in which degree low frequency right prefrontal~     rTMS used ad add-on may potentiate the antidepressant effect of unilateral ECT and accelerate~     remission .~      To investigate the correlation between blood concentration of specific inflammation makers~     and change in depressive symptoms during treatment~   "
110288|NCT02123862|"~     The purpose of this study is to evaluate the number of circulating tumor cells (CTC) before~     and after treatment using an experimental method for detecting CTC, compared to commercial~     CTC assay results, in patients with prostate, breast or colorectal cancers.~      Experiments will be done to develop a new assay technique and also test how CTC react to~     commonly used drugs. This information will be analyzed to determine if the experimental~     assays can be helpful in the future to predict how a patient's cancer may react to certain~     treatments.~      The research experiments will also attempt to grow CTC for long-term or immortal cell lines~     that can be further studied for proteins and gene mutations related to the specific tumor~     (not familial), and testing for sensitivity to drugs.~      Blood samples will be collected at specific time points during routine medical care from~     patients with prostate, breast, colorectal or other solid tumor cancer. Samples will also be~     collected from patients with no cancer for comparison purposes. Samples for the experimental~     tests will be identified only by codes and results will not be shared with participants.~     Patients with prostate, breast or colorectal cancer will also have blood samples drawn for~     commercial CTC assays as part of their standard care.~   "
110289|NCT02123849|"~     This randomized phase II trial studies the safety and effects of acetylsalicylic acid~     (aspirin) taken continuously or intermittently on gene expression in the nasal tissue of~     current smokers. Smokers are at increased risk of developing lung cancer. Acetylsalicylic~     acid may be useful in preventing lung cancer.~   "
110290|NCT02123836|"~     A novel method has been developed to expand natural (NK) cells and enhance their cytotoxicity~     against cancer cells while maintaining low killing capacity against non-transformed cells. In~     this method, donor NK cells are expanded by co-culture with the irradiated K562 cell line~     modified to express membrane bound IL-15 and 41BB ligand (K562-mb15-41BBL). Expression of~     these proteins in conjunction with unknown stimuli provided by K562 cells promotes selective~     growth of NK cells. Then, the expanded NK cell population is depleted of T cells to prevent~     graft versus host disease (GVHD). Expanded and activated NK cells showed powerful~     anti-leukemic activity against acute myeloid leukemia (AML) cells in vitro and in animal~     models of leukemia.Unpublished laboratory results also demonstrated that T-cell acute~     lymphoblastic leukaemia (T-ALL) is extremely sensitive to the cytotoxicity exerted by the~     expanded and activated NK cells.~      The present study represents the translation of the laboratory findings into clinical~     application. The study proposes to determine the feasibility, safety and efficacy of infusing~     expanded NK cells into patients who have AML or T-lineage ALL which is resistant to standard~     therapy as demonstrated by persistent minimal residual disease (MRD). Patients with~     myelodysplastic syndrome (MDS), who are at high risk to develop AML will also be eligible for~     the study. In this patient cohort, the study will also investigate the in vivo lifespan and~     phenotype of the expanded NK cells.~      The main hypothesis to be tested in this study is that infusion of expanded activated NK~     cells can produce measurable clinical responses in patients with AML or T-ALL.~   "
110291|NCT02123823|"~     Phase Ib / II study to determine the Maximum Tolerated Dose and Recommended Phase II Dose,~     and to evaluate the safety and antitumour activity, of BI 836845 and everolimus in~     combination with exemestane in women with HR+/HER2- advanced breast cancer~   "
110292|NCT02123810|"~     The investigators sought to evaluate the influence of fatigue after a night shift on the~     quality of Chest Compressions (CC) in CardioPulmonary Resuscitation (CPR), among physicians.~   "
110293|NCT02123797|"~     Lung cancer kills 160,000 patients annually; this represents 28% of all US cancer deaths. The~     overall year survival rate has only improved from 12% to 17% in 33 years. This failure~     reflects the innate lethality of lung cancer, but also reflects defects in patient care~     delivery. Care for the lung cancer patient starts with an abnormal radiologic scan, proceeds~     through a diagnostic biopsy, tests to determine the extent of spread of the disease (stage),~     selection of appropriate treatment, and finally ends with patient outcomes. At each step are~     multiple options and independent specialists, each one engaged by a process of sequential~     referrals in the serial care model. This process is often not user-friendly, is riddled with~     inefficiency, delays, and outcome variances.~      The coordinated multidisciplinary model, in which patients and their doctors collaborate to~     provide evidence-based care, is believed by experts to be superior, but has few examples of~     successful implementation. The implementation gap exists because of the paucity of good~     quality data, and lack of implementation know-how.~      Embedded in the highest US lung cancer mortality zone, the greater Memphis area has a~     racially, culturally, economically and geographically diverse population. The investigators~     research group has shown how poor quality care impairs patient survival in this region and in~     the greater US. The investigators have linked patient survival to compliance with~     multidisciplinary care plans. In this project, the investigators propose to rigorously test~     the impact of the multidisciplinary care model on patient outcomes in a community-based,~     private practice environment, similar to where 70% of lung cancer care is delivered in the~     US.~      The objective of this study is to provide high-level evidence of the impact of~     multidisciplinary care on lung cancer patient outcomes. Multidisciplinary care is defined as~     a model of care in which patients, their care-givers and key specialists concurrently and~     directly evaluate the same patients in the presence of the patients and their informal~     caregivers, in order to develop evidence-based consensus care plans~   "
110294|NCT02123784|"~     Identification of biomarkers that can predict the outcome of the surgical treatment (i.e. the~     rate of re-rupture) of tears in the rotator cuff tendon.~   "
110295|NCT02123771|"~     The investigators hypothesis:~      Presence of anti-GGT (antibody against GGT) indicates H. pylori infection.~   "
110296|NCT02123758|"~     The purpose of this study is to investigate potential drug-drug interaction (DDI) between~     JNJ-56021927 and abiraterone acetate and between JNJ-56021927 and prednisone, determine~     safety of the combination and evaluate in a descriptive manner the efficacy in these~     participants. It will also, potentially provide dosing recommendations for abiraterone~     acetate in future studies when combined with JNJ-56021927.~   "
110297|NCT02123745|"~     A single arm trial consisting of 70 adult volunteers to assess the safety and efficacy of the~     ivWatch Model 400 when observing infiltrated tissues at common sites for peripheral IV~     therapy.~   "
110298|NCT02123732|"~     This is a 2-arm, single-blind, crossover, placebo-controlled clinical study, with 24 weeks of~     therapy to evaluate the efficacy and safety of DbXell in improving metabolic control in~     patients with Type 2 Diabetes that is mildly uncontrolled, defined as HbA1c above target but~     less than 8.0% on their current conventional therapy.~   "
110299|NCT02123719|"~     Retrospective analysis of patients undergoing laparoscopic incisional hernia repair.~      Study group: Patients with incisional hernia post liver transplantation Control group:~     Patients with incisional hernia post any other laparotomy in the upper quadrant.~      Primary study outcome parameter: Risk of hernia recurrence. Secondary study outcome~     parameters: - Hernia repair-related infection rate~      - Postoperative morbidity Statistical analysis: Comparison of study versus control group,~     univariate and multivariate analysis, Chi² and Mann-Whitney-U tests. P-values <0.05 were~     considered significant.~   "
110301|NCT02123680|"~     Non-specific chronic low back pain guidelines recommend rehabilitation along with a~     biopsychosocial approach. However, though psychological and social issues address important~     needs of professionals and patients, they have been scarcely developed in this area so far.~     Noteworthy, little is known about patients' expectations relative to physiotherapy for~     chronic low back pain (CLBP), while professional recommendations advocate taking them into~     consideration.~      A study about patients' experience will provide knowledge about the ill person's perspective~     and how the physiotherapists are perceived as well as the role attributed to them. The aim of~     this study is, thus, to explore the experience of the patients suffering from CLBP in order~     to highlight their expectations toward physiotherapy services and physiotherapists.~      The investigators will apply a critically interpretive socio-anthropological approach based~     on patients' interviews and observations in an intensive CLBP rehabilitation program. The~     results will help improve the care patients receive by facilitating the integration of~     biopsychosocial issues related to patient's expectations into the treatment.~   "
110302|NCT02123667|"~     Multinational, multicentre, non-pharmacological intervention, cross-sectional and~     longitudinal study.~   "
110303|NCT02123654|"~     The purpose of this study is to demonstrate that the proportion of treatment-naive~     non-cirrhotic subjects with Genotype (GT)-1b treated with Daclatasvir (DCV)/Asunaprevir~     (ASV)/BMS-791325 who achieve Sustained Virologic response (SVR12), defined as Hepatitis C~     virus (HCV) RNA < LOQ target detected or target not detected (LOQ TD/TND) at follow-up Week~     12, is significantly higher than SVR12 of current Standard of Care (SOC).~   "
110304|NCT02123641|"~     A minimum of 450 healthy individuals (62-70 years old) will be recruited.~      Each individual will be randomized into one of three groups stratified according to gender~     (M/F), BMI (≤28/>28), and 30 sec chair stand (≤11/>11). The three groups are Heavy resistance~     training (n=150), moderate intensity training (n=150), and control (n=150, no training).~      Assessments will be performed at baseline, after 12 months of intervention. Furthermore,~     follow up will be performed after 2,4,7, and 10 years.~      The primary outcome is change in leg extensor power after the intervention and during follow~     up.~      The primary hypothesis is that by applying the intention-to-treat analysis, the moderate~     intensity training group will increase leg extensor power just as much as the heavy~     resistance training group. The two training groups will increase muscle power more than the~     control group.~   "
110305|NCT02123628|"~     The purpose of the study is to compare the efficacy and tolerance of 6- versus 12-week~     antibiotic therapy in patients with diabetic foot osteomyelitis treated medically.~   "
110306|NCT02123615|"~     ASIS Corporation (ASIS) has developed the only automatic injection system for delivery of~     injectable products to it's optimum/right spot, just outside of the fascia, which exists~     subdermally (between the skin and muscle). Bloodless basically implies longer lasting~     medicinal effects, and minimal side effects - advantages that reflect the NIH mission of~     enhancing health, lengthening life, and reducing the burdens of illness and disability. ASIS~     device is stabilized on the surface of the skin with negative pressure and emits an~     electrical current to create a bloodless cavity subdermally. ASIS device correctly,~     automatically, and consistently delivers therapeutic agents, yet requiring little skill of a~     practitioner - providing the steady and safe infusion into subdermal bloodless space of~     virtually any injectable product in addition to Botox, including GAMMAGARD LIQUID, Enbrel,~     Insulin, and Fillers, etc. According to the FDA, This innovation will have major impact on~     the healthcare industry.~   "
110307|NCT02123602|"~     The investigators hypothesize that the use of trunk (core) stabilization exercises early in~     treatment combined with lower extremity exercises will enhance the outcome over lower~     extremity exercises alone in the treatment of young athletes with anterior knee pain.~   "
110308|NCT02123589|"~     The study was designed to explore the effects of different sedation protocol on incidence~     rates of delirium and PTSD in severe patients with mechanically ventilation.~   "
110309|NCT02123576|"~     Pentoxyfylline therapy in addition to the standard of care of albumin, midodrine and~     octreotide therapy is superior to the standard of care alone in the treatment of Type I~     hepatorenal syndrome in the first 14 days of hospitalization.~   "
110310|NCT02123563|"~     Diabetes and obesity affect many people in different countries. Similarly, millions of people~     have some type of gum disease such as gingivitis. The present study was conducted to clarify~     if systemic conditions such as diabetes and obesity could impair the response to gingivitis~     treatment. Subjects with gum disease showing diabetes type II (from 40 to 50 subjects),~     slight to moderate obesity (from 40 to 50 subjects) or its combination (from 40 to 50~     subjects) were selected for the present study. In addition normal-weight subjects with gum~     disease (from 40 to 50 subjects) besides a group without gum disease (from 40 to 50 subjects)~     were selected for comparisons. After verbal and written explanations about the study,~     subjects who matched study criteria and who signed the informed consent form underwent full~     oral examinations in two separate visits. In the first visit, after a clinical examination to~     verify the levels of gingival inflammation and the accumulated amounts of dental plaque, the~     bone height was determined by X-Ray examinations. Bad breath was also evaluated by a~     chair-side apparatus. Additional laboratorial examinations included a) quantification of~     bacteria that cause gum disease from dental plaque samples, b) quantification of inflammatory~     products from gingival fluid sampling and c) quantification of produced saliva. Self-report~     questionnaires were used to check the impact of oral condition and treatment of gum disease~     in quality of life and individual daily performance. These examinations were repeated 3~     months after dental treatment. All subjects received ultrasonic dental prophylaxis for~     cleaning their teeth. Based on systemic/oral conditions each group rinsed either an~     essential-oils containing mouth rinse or a placebo rinse. First rinse was supervised and the~     other ones were performed at home twice a day for three months. Each participant also~     received a toothbrush, a dental floss and a fluoride toothpaste monthly after oral hygiene~     instructions. Adherence to the treatment and occurrence of undesirable side effects were~     monitored throughout the study.~   "
110311|NCT02123550|"~     This prospective controlled study examines the use of Doppler ultrasound as a means to screen~     elective plastic surgery patients for the presence of deep venous blood clots both before and~     after surgery. This is a noninvasive technique that is known to be both sensitive and~     specific for the detection of deep venous thromboses in the lower extremities. This method~     may make it unnecessary to select patients for prophylactic anticoagulation, which poses~     additional risks to the patient.~   "
110312|NCT02123537|"~     People with multiple sclerosis (MS) often suffer from foot drop, which impairs their walking~     ability. Foot drop is the inability to lift the foot during the swing phase of walking. The~     purpose of this study is to find out if electrical stimulation of the leg, using the Bioness~     L300 Foot Drop System, can be used to treat foot drop in people with MS. It is expected that~     using this system will reduce foot drop, and therefore improve walking ability, particularly~     in the areas of speed, strength, balance and falls.~   "
113078|NCT02087358|"~     This 3 weeks study examines the correlation between stress and alcohol using an ecological,~     prospective design.~   "
110319|NCT02123446|"~     The purpose of this study is to compare two different preparations of an antibiotic called~     cephalexin in capsules to determine if they are essentially the same. The study has two~     periods. Participants will receive one preparation of cephalexin in each period. At least 7~     hours will pass between the study periods. The study is expected to last about 2 days for~     each participant, not including screening or follow-up.~   "
110320|NCT02123433|"~     S. pneumoniae is frequently isolated from nasal swabs of healthy subjects, but it can also~     cause severe diseases (pneumonia, bacteraemia, meningitis and sepsis).HIV-infected subjects~     are more sensitive to invasive diseases and recurrent infection than the general population.~     Nasal carriage is the main pathogenetic feature for invasive disease: bacteraemia is more~     frequent in carriers, HIV+ patients are constantly colonized by the same pneumococcal strain~     and their nasopharyngeal isolates have features similar to subsequent invasive strains. A~     23-valent polysaccharide vaccine (PPV23) has long been available and recommended in the HIV+~     population as prophylaxis for invasive disease. Studies regarding efficacy of PPV23 in HIV+~     are controversial and highlight that immune response induced by PPV23 in HIV+ is poor and an~     hyporesponsiveness to repeated polysaccaridic antigens stimulation can occur. Moreover, PPV23~     seems not to affect pneumococcal carriage status and could lead to emergence of non-vaccine~     serotypes. The conjugation of pneumococcal capsular polysaccharides to carrier proteins~     results in an improved T-cell dependent immune response, characterized by increased antibody~     concentrations and induction of T and B memory cells, with a demonstrated higher efficacy in~     children. A heptavalent vaccine conjugated with diphtheria toxoid (PCV7) is approved in~     Europe since 2001 and is effective in reducing incidence of invasive disease by vaccine~     serotypes (4, 6B, 9V, 14, 18C, 19F, 23F), in both children and adults, due to effect of herd~     immunity. A PCV13 formulation has recently been developed, covering PCV7 serotypes plus 1, 3,~     5, 6A, 7F and 19A. PCV13 revealed the same safety profile as PCV7 in pediatric patients, that~     are the main target of conjugate vaccines licensure. Some trials showed a better antibody~     response in terms of quantity and quality in HIV + adults by using PCV7 as compared to PPV23.~     However these data were not unequivocally confirmed in further studies on the use of PCV7~     alone or in combination with PPV23. The first trials of PCV13 use in adults showed the same~     or even better response compared to PPV23, with a safety and tolerability similar to PCV7.~     PCV13 in HIV+ adults is a promising candidate prophylactic measure for pneumococcal~     infections. The purpose of this study is to evaluate serological response and prevalence of~     nasopharyngeal colonization by S. pneumoniae in HIV+ non-hospitalized adults, following~     vaccination with 2 doses of PCV13.~   "
110321|NCT02123420|"~     The present study tested the hypothesis that Platform Switching (PS) and Regular Platform~     (RP) implants would have different outcomes in the bilateral single tooth replacements~     against the alternative hypothesis of no difference.~   "
110322|NCT02123407|"~     Carbon Nanoparticles (CNP),with a mean size of 150 nm,can be taken up selectively by~     lymphatics after injection into the tissue and draining regional lymph nodes are thereby~     colored black,which may provide surgeons the guidance to lymph node dissection and help them~     harvest lymph nodes after surgery,especially some small ones. but there was insufficient~     evidence to justify its efficacy for those purposes.Therefore,the investigators carried out a~     prospective randomized controlled trial on lymph node vital staining for lymph node~     dissection and harvesting in advanced gastric cancer to test this idea.~   "
110323|NCT02123394|"~     The purpose of this study is to assess the efficacy of the McKenzie method in patients with~     chronic non-specific low back.~   "
110324|NCT02123381|"~     This study aim to investigate Changes in tumor tissue and serum biomarkers before and after~     cetuximab combined with preoperative radiotherapy in locally advanced thoracic middle-lower~     segment esophageal squamous cell carcinoma.We want to find one or more effective biomarkers~     to predict and evaluate the patients who will be benefit from cetuximab combined with~     preoperative radiotherapy.~   "
110325|NCT02123368|"~     Purpose: To determine the safety, feasibility and effectiveness (clinical and radiological)~     of intra-articular administration of autologous mesenchymal stem cells (MSCs) in patients~     with knee osteoarthritis.~      Patients and methods~      Clinical trial phase I- II, randomized , multicenter , with three treatment arms and 10~     patients for each group. The investigators compare the intraarticular injection of hialuronic~     acid against the administration of two different doses of mesenchymal stem cells with~     hialuronic acid according to the following scheme:~        1. Group A: intra-articular injection of hyaluronic acid (Hyalone®). Single dose.~        2. Group B: Low Dosage of MSCs . Intra-articular injection of 10 million autologous~          mesenchymal progenitor stem cells cultured ex - vivo (cell suspension sterile small~          volume (5-10 ml ) in a vehicle suitable for intraarticular injection ) followed by an~          intraarticular injection Hiaurónico Acid ( Hyalone®).~        3. Group C : High dose of MSCs. Intra-articular injection of 100 million autologous~          mesenchymal progenitor stem cells cultured ex - vivo ( cell suspension sterile small~          volume (5-10 ml ) in a vehicle suitable for intraarticular injection ) followed by an~          intraarticular injection Hiaurónico Acid (Hyalone®).~      The primary endpoint is safety and feasibility. The investigators registered the occurrence~     of complications and / or adverse effects during the study.~      In addition the investigators assess the response to intra-articular infusion of CMM~     analyzing the following parameters:~        -  Clinical assessment of pain and function (Baseline, 1, 3, 6 and 12 months since~          treatment): VAS , WOMAC , KOOS , EuroQol, SF-16, Lequesne , WOMAC , KOOS.~        -  Radiographic (baseline, 6 and 12 months since treatment): Femorotibial space.~        -  Radiographic using MRI (baseline, 6 and 12 months since treatment): by assessing the~          number location of the lesions , cartilage thickness , signal intensity , subchondral~          bone alteration , volume and WORMS and dGEMRIC protocols.~   "
110326|NCT02123355|"~     The incidence of postoperative cognitive dysfunction (POCD) is high and POCD affect the life~     quality and the prognosis of patients. Geriatrics is the independent risk factor of POCD, and~     POCD is also correlated with many other factors such as type of surgery, the duration of~     anesthesia and the anesthesia drugs used et al. So, the prevention and treatment of POCD in~     geriatrics is important.~      Dexmedetomidine is found to have the effect of neuro-protection, but it is controversy~     whether Dexmedetomidine has the effect of neuro-protection in geriatrics, especially the~     prolonged surgery.~      The purpose of this study is to explore the effect of Dexmedetomidine to the cognitive~     function at prolonged surgery in geriatrics in geriatrics.~   "
110327|NCT02123342|"~     The purpose of the study is:~      1) To evaluate the efficacy and feasibility of an SMS reminder intervention for promoting an~     health-related exercise programme (myPAtHS) among older Malaysian adults, in a randomized~     controlled trial (RCT).~      Hypothesis: Frequency and duration of the exercise programme execution will be higher for the~     SMS reminder condition compared to the programme only condition. The effect may be reduced~     from post- to follow-up measurement (24 weeks after baseline and 12 weeks after~     post-measurement) but all outcomes will remain significantly higher at 24 weeks.~   "
110337|NCT02123212|"~     The Birth-Cohort Evaluation to Advance Screening and Testing for Hepatitis C (BEST-C)~     compares the effectiveness of the birth cohort HCV screening strategy with the current~     risk-based screening approach to detect previous unidentified persons with viral hepatitis C~     who receive health care in primary systems.~      The study involved three clinical sites, The University of Alabama, Birmingham; The Henry~     Ford Health System; and the Mount Sinai Medical Center, each of which developed an~     independent intervention to experimentally compare the number of positive Hepatitis C Virus~     (HCV) diagnoses found using the birth-cohort screening approach with that found using~     traditional risk-based screening, or standard of care strategies. Birth cohort testing is~     defined as the systematic recommendation of HCV antibody testing to any persons born during~     the years of 1945 to 1965 who do not have clinically documented evidence of a prior antibody~     test without regards to the patient's stated risk of exposure to the virus.~   "
110338|NCT02123199|"~     A prospective observational multi centre research study in GP practices clustered within up~     to 10 UK Primary care trusts.~   "
110328|NCT02123329|"~     Thirty seven percent of adult male population smoke cigarettes in Qatar. The Global Youth~     Tobacco Survey also stated that 13.4% of male school students aged 13 to 15 years in Qatar~     smoke cigarettes. Smoking cessation is a key to reducing smoking related diseases and deaths.~     Health care providers are in an ideal position to encourage smoking cessation. Pharmacists~     are the most accessible health care providers and are uniquely situated to initiate behavior~     change among patients. Many western studies have shown that pharmacists can be successful in~     helping patients quit smoking. Studies demonstrating the effectiveness of pharmacist~     delivered smoking cessation programs are lacking in Qatar. This proposal aims to test the~     effect of a structured smoking cessation program delivered by trained ambulatory pharmacists~     in Qatar. A prospective, randomized, controlled trial will be conducted at 8 ambulatory~     pharmacies in Qatar. Participants will be randomly assigned to receive a 4-session~     face-to-face structured patient-specific smoking cessation program conducted by the~     pharmacist or 5 to 10 minutes of unstructured brief smoking cessation advice given by the~     pharmacist. Both groups will be offered nicotine therapy if feasible. The primary outcome of~     smoking cessation will be confirmed by exhaled carbon monoxide test at 12 months. If proven~     to be effective, this smoking cessation program will be considered as a model that Qatar and~     the region can apply to decrease smoking burden.~   "
110329|NCT02123316|"~     To evaluate the efficacy of an extract of Dermatophagoides pteronyssinus versus placebo in~     the treatment of local allergic rhinitis. The primary efficacy endpoint is the reduction in~     symptom scores and medication use in the active group compared to placebo.~      The influence of treatment in in vitro and in vivo objective parameters was also~     assessed.~   "
110330|NCT02123303|"~     Orthostatic hypotension (OH) is defined as a fall in blood pressure when standing. Several~     different underlying diseases, conditions, or combinations of medicines may contribute to OH;~     therefore the cause of the condition varies among individuals. Some studies have shown that~     OH is associated with an increase in the rate of death, but it is not clear what role OH~     plays in increased morbidity. By studying what the prevalence of OH is in a generalized~     veteran population we expect increase clinical awareness of the degree of the problem so that~     patient care might be improved.~   "
110331|NCT02123290|"~     This will be a Proof-of-concept / Phase IIa, open label study to examine the efficacy of~     DSM265 in uncomplicated Plasmodium vivax and Plasmodium falciparum blood-stage malaria in~     adult patients. A minimum of two cohorts (20 patients) and a maximum of 6 cohorts (60~     patients, 3 dose levels) will be tested. The starting dose of DSM265 for the first P. vivax~     and P. falciparum cohorts will be 400 mg. This dose is expected to show complete clearance of~     parasites by microscopy by Day 7 and a decrease in recrudescence rate assessed at Day 14~     (success criteria for dose de-escalation and continuation of the study).~   "
110332|NCT02123277|"~     The study aim is to evaluate the tubal score on patients who suffer from obstructive~     dysfunction of eustachian tube before and after the eustachian tube dilatation.~   "
110333|NCT02123264|"~     The progression of structural joint damage is the leading cause of disability and~     socioeconomic costs associated with rheumatoid arthritis (RA). Remission and low clinical~     activity not always imply absence of progression of structural damage. The main objective of~     this study is to evaluate the progression of radiological damage in early RA patients~     currently treated with disease modifying anti-rheumatic drugs (DMARDs) and low disease~     activity to which treatment with zoledronic acid is added.~      The investigators propose a randomized clinical trial in 94 patients with RA of less than 2~     years of evolution that, being treated with DMARDs, present criteria of low disease activity~     (DAS28 < 3.2).~      Patients will be randomized into two branches: zoledronic acid and no treatment. The primary~     study endpoint is the progression of radiological damage assessed in a blinded way by the~     difference in the Sharp-van der Heijde index (SHI) in radiographs of hands and feet after two~     years; the secondary variables: radiographic progression after one year, serum bone~     biomarkers (OPG, RANKL, DKK-1 and sclerostin) and adverse effects. In a subgroup of patients,~     the investigators shall evaluate the change in the size of hand erosions by multislice~     computed tomography and the evolution of periarticular osteoporosis and systemic bone mass by~     dual X-ray absorptiometry (DXA).~   "
110334|NCT02123251|"~     The purpose of this randomized controlled trial study is to examine the extent that financial~     incentives when combined with diabetes evidence-based practices, improve self-management and~     biometric measures for adult diabetic Medicaid recipients with an HbA1c of ≥ 6.5 at~     enrollment. The study will also evaluate the cost-effectiveness of the program.~      Specific Aims:~        1. Evaluate whether financial incentives for completing ADA recommended tests, exams and~          vaccinations will improve compliance rates.~        2. Evaluate whether financial incentives for health education and biometric outcomes will~          improve diabetes patients' self-management.~        3. Evaluate the extent to which financial incentives for healthy behaviors reduce health~          care utilization.~   "
110335|NCT02123238|"~     The study aims to evaluate the effect of non-supine positioning in the treatment of surgical~     patients with obstructive sleep apnea. The hypothesis is that non-supine positioning will~     result in a decrease in acute hypoxic events, defined as the number of apneas/hypopneas per~     hour of sleep.~   "
110336|NCT02123225|"~     The goal of this study is to determine if the investigators can use the STOP-BANG score to~     identify those patients at risk for worsening Obstructive Sleep Apnea (OSA) symptoms in the~     early postoperative period after major surgery.~      Hypotheses:~        1. - Postoperative sleep apnea parameters will be worse when compared to baseline in~          patients with higher scores on the STOP-BANG.~        2. - A higher STOP-BANG score will be predictive of worsening sleep apnea parameters in~          patients undergoing Total Knee Arthroscopy (TKA).~   "
110339|NCT02123186|"~     To test if the routine newborn screening dried blood spots can be used to test if missing 2~     copies of SMN1 gene, a status indicating spinal muscular atrophy~   "
110340|NCT02123173|"~     Non-intubated thoracoscopic surgery has been proved as an adequate alternative for management~     of many lung conditions such as pneumothorax , lung volume reduction, pulmonary~     metastasectomy, removal of lung nodules, segmentectomy and lobectomy. However, the~     hemodynamic changes during one lung ventilation have not been fully investigated. The goals~     of this study are to compare the changes of hemodynamics (including blood pressure, heart~     rate, cardiac output, pulse pressure variation, fluid responsiveness) during one lung~     ventilation between conventional intubated and non-intubated vedio-assisted thoracoscopic~     (VATS) operations.~   "
110341|NCT02123160|"~     This study compares the effectiveness of Child Parent Psychotherapy to that of usual care~     (defined as: referral to therapists in the community or Columbia University Medical Center)~     in improving maternal depressive symptoms and child emotional and behavioral disturbances.~     The investigators will recruit mothers who report being mildly to moderately depressed and~     their preschoolers (ages 3-5 years) who they are concerned are exhibiting emotional and/or~     behavioral problems.~   "
110342|NCT02123147|"~     Sjögren's syndrome (SjS) is an autoimmune disease characterized primarily by exocrine gland~     dysfunction, specifically of the salivary and lacrimal glands, resulting in dry mouth and dry~     eyes symptoms. It can be systemic by affecting other organs including the gastrointestinal~     tract, skin, lungs, vasculature, kidneys, bladder and vagina. Involvement of the musculature~     can lead to fibromyalgia-like symptoms and chronic fatigue, while approximately 20% of~     patients develop various neuropathies, including sensory, peripheral, cranial and myelopathic~     neuropathies exhibited by cognitive impairments such as dementia, lack of concentration,~     memory loss and various psychiatric disorders. Like most autoimmune connective tissue~     diseases, SjS shows a sexual dimorphism with women affected 10-times more frequently than~     men, suggesting a role for sex hormones in disease susceptibility or progression. One common~     feature of SjS is it infiltration of mononuclear cells into the salivary and lacrimal glands,~     aggregating into clusters referred to as lymphocytic foci (LF). Critical to the studies~     proposed is the fact that a predominant cell population of LF is the pathogenic TH17 cell~     that produces IL-17 cytokine and autoreactive B cells reactive to M3R, Ro, and La~     autoantigens. The goal of this study is characterize the change in receptor gene repertoires~     of autoreactive B and T cells at different time points during the disease process and examine~     the correlation with various disease parameters.~   "
110343|NCT02123134|"~     The objectives of this study are to explore the safety and efficacy of subcutaneous~     injections of ATX-101 relative to placebo, in the submental area of subjects who are 65 to 75~     years old.~   "
110344|NCT02123121|"~     Resveratrol, a compound found in red wine and dark-skinned grapes, will improve the function~     of mitochondria (energy producing components) within the leg muscles of moderate functioning~     older adults.~      The investigators will look at the role Resveratrol plays in improving physical function by~     studying the connection of changes in mitochondrial function and changes in physical~     function.~   "
110345|NCT02123108|"~     This is an investigator initiated study at the University of California, Los Angeles (UCLA)~     funded by Novartis looking at using a combination of immunosuppressive drugs in liver~     transplant patients that are at risk of developing kidney problems. Kidney problems following~     liver transplants is the most problematic issue facing liver transplant patients today.~      This study will generate information in this area of high unmet medical need utilizing~     basiliximab and Myfortic and using a reduced dose of tacrolimus, one of the current standard~     of care medications, after kidney function has normalized.~      This study will enroll 60 subjects. 30 subjects in each of the two groups. Subjects will be~     followed for 1 year after liver transplant.~   "
110346|NCT02123082|"~     Urolithiasis (kidney stones) is a common disease process affecting people all across the~     world. Usually, if the stone size is small, it is able to pass through the urinary system and~     exit the bladder on its own with no treatment. However, when the size of the stone is bigger,~     it can get trapped in the kidney or the ureter, causing significant pain for the patient and~     potentially obstructing urine flow. If this occurs, surgical treatment is necessary for the~     removal of the stone. The surgical procedure often employed involves the use of a~     ureteroscope, which is a device that includes a camera and channels for working instruments~     such as a grasper and laser fiber to be placed during a procedure. Ureteroscopes that are~     currently in use are flexible and have the ability to treat stones that may otherwise be~     inaccessible in the kidney. Most flexible ureteroscopes in clinical use currently only have~     one channel therefore only allowing one instrument to be used at a time. Recently, a new type~     of ureteroscope has been introduced in the market that offers the advantage of having two~     working channels where two instruments can be inserted for use during stone treating~     procedure. This can potentially decrease procedure time for patients affected by kidney~     stones.~      The purpose of this research is to compare the efficacy and safety of the ureteroscopes that~     have only one channel for instrument insertion with the newer ureteroscope that has two~     channels for utilization during stone treatment.~   "
110347|NCT02123069|"~     The purpose of this study is to learn how uterine fibroids may be connected to heart disease~     and high blood pressure. It is not known what causes fibroids, but they frequently occur in~     women who also have high blood pressure, heart disease, and stroke. The investigators of this~     study want to learn if certain changes in the blood vessels or nerve activity can put women~     at risk for these diseases and for fibroids.~   "
110348|NCT02123056|"~     Syncope affects about 50% of Canadians, is the cause of 1-2% of emergency room visits, and~     probably is responsible for CDN $250 million in health care spending each year. It is~     associated with decreased quality of life, trauma, loss of employment, and limitations in~     daily activities. The most common cause is vasovagal syncope.~      This occurs in people of all ages, and is a lifelong predilection. While the median number of~     faints in the population is 2, those who come to the investigators care have a median 10-15~     lifetime spells, and have an increased frequency in the year before presentation. Vasovagal~     syncope is due to abrupt hypotension and transient bradycardia, which cause cerebral~     hypoperfusion. The pathophysiology may be either failure of venous return or progressive~     vasodilation, both due to inappropriately low sympathetic outflow. Sympathetic stimulation~     might be involved early in the reflex cascade. There is no known medical treatment for~     frequent fainting. The investigators performed the pivotal CIHR-funded randomized trials that~     showed that neither permanent pacing, beta blockers, nor fludrocortisone help the majority of~     patients.~      However 3 observational studies suggested that beta blockers prevent syncope in older~     subjects, and the Prevention of Syncope Trial (POST1) showed in a prespecified, -stratified~     analysis that patients ≥42 years tended to benefit. The investigators recent meta-analysis~     showed a benefit from metoprolol in these patients, with a hazard ratio of 0.52 (CI 0.27 to~     1.01), and an age-specific response to beta blockers (p = 0.007). These results suggest the~     need for a randomized clinical trial of metoprolol for the prevention of vasovagal syncope in~     older subjects. Accordingly,the investigators conducted a poll of 48 cardiologists and~     neurologists in Canada and abroad: 98% stated that a randomized trial was necessary, and 92%~     agreed to participate in such a trial. Separately, this study emerged as the first choice for~     syncope randomized trials after consultation with Canadian and international experts.~      Objective: To determine if treatment with metoprolol in patients ≥40 years old with moderate~     to severely frequent vasovagal syncope will better suppress syncope recurrences than placebo.~      Methods: This will be a longitudinal, prospective, parallel design, placebo-controlled,~     randomized clinical trial.~      Patients will be enrolled during a recruitment period of 4 years and followed for a fixed~     period of 1 year. Subjects will have had ≥1 faint in the previous year, and a diagnosis of~     vasovagal syncope based on a quantitative diagnostic score. They will be randomized to~     receive either metoprolol or placebo at an initial dose of 50 mg bid. Dose adjustments will~     be made according to treating physician discretion to optimize tolerance and compliance while~     maximizing dose. The primary outcome measure will be the time to the first recurrence of~     syncope (after a 2 week dose titration wash-in period) over the 1-year observation period.~     The primary analysis will be performed on an intention-to-treat basis. Secondary analyses~     will include an on-treatment analysis, as well as analyses comparing syncope and presyncope~     frequency, number needed to treat, quality of life, impact of syncope on daily living, and~     cost from the perspective of the publicly funded health care system. The investigators will~     enroll 248 patients to have an 85% power to detect a reduction (p<0.05) in the primary~     outcome from 50% (placebo group) to 30% (midodrine group), a 40% relative risk reduction.~     This sample size also allows for a 11% rate of subject dropout with loss to follow-up before~     a syncopal event. The University of Calgary Syncope Clinic has a well-functioning clinical~     trial apparatus that successfully completed the randomized, multicenter Prevention of Syncope~     Trials (POST1: metoprolol for vasovagal syncope; POST2: fludrocortisone for vasovagal~     syncope) and SIRCAT (Statin-Induced Reduction of Cardiomyopathy Trial). Enrolment is underway~     in the CIHR-funded POST3 (pacing versus loop recorders in syncope patients with bifascicular~     block) and POST4 (midodrine for vasovagal syncope). Study centres that were highly productive~     in POST1-4 have agreed to participate. The investigators therefore will have ample syncope~     enrolling centres.~      Relevance: This study will provide evidence to inform the use of metoprolol in the treatment~     of moderate to severely frequent syncope in older patients with vasovagal syncope. Given the~     lack of any other conventional medical therapy the investigators expect it to have rapid~     impact on care.~   "
110349|NCT02123043|"~     Many older adults lack the skill of efficient wheelchair propulsion despite being the largest~     cohort of wheelchair users. Inefficient wheelchair propulsion can lead to fatigue and overuse~     injuries that can result in lost independent mobility. This study will evaluate the~     effectiveness of a new training strategy using a motor learning based approach to train~     efficient wheelchair propulsion. Participants will be randomly assigned to one of three~     groups: 1) No practice; 2) Motor learning-based training; or 3) Practice (time-matched to~     training). Potential improvements based on training will be explored for wheeling~     biomechanical variables and energy efficiency.~      Study Hypothesis: We expect that the Training intervention will be superior to the Practice~     intervention for improving the biomechanical and physiological efficiency of wheelchair~     propulsion. It is also hypothesized that both the Training and Practice interventions will be~     superior to no practice.~   "
110350|NCT02123030|"~     Use of a microfabricated silicon device to concentrate ultra trace volatile organic compounds~     (VOCs) in human exhaled breath for quantitative analysis of VOCs.~   "
110351|NCT02123017|"~     The purpose of the study is to evaluate the efficacy and safety of bisacodyl combined with~     escalating doses of lactulose to be used as a preparation for colonoscopy.~   "
110352|NCT02123004|"~     1. Ticagrelor inhibits inflammation and improves vascular endothelial cell function to a~          greater extent than clopidogrel in ST-segment elevation myocardial infarction(STEMI)~          patients receiving percutaneous coronary intervention.~        2. Ticagrelor can reduce the serum levels of inflammatory biomarkers both in coronary and~          in peripheral venous in patients with ST-segment elevation myocardial infarction(STEMI).~   "
110353|NCT02122991|"~     Increased life expectancy in individuals with spinal cord injury (SCI) present clinicians~     with the challenge of managing the secondary complications of SCI with the chronic diseases~     common in an aging population. Cardiovascular disease, cerebral vascular disease, and~     cognitive dysfunction are among the primary challenges facing clinicians in the treatment of~     an aging population. Cognitive dysfunction has been reported in upwards of 60% of the SCI~     population, which have been primarily attributed to concomitant traumatic brain injury or~     pre-morbid conditions. Identifying possible modifiable risk factors which contribute to the~     increased prevalence of cognitive dysfunction in the SCI population is of significant~     clinical relevance and cardiovascular and cerebrovascular disorders have emerged as possible~     contributors to the cognitive disorders in the general population. These risk factors~     include: physical inactivity, chronically low or high blood pressure (BP), reduced blood flow~     to the brain, arterial stiffening, and impaired nervous system regulation of the~     cardiovascular system. These risk factors are particularly prominent in the SCI population as~     they represent a model of profound inactivity, have trouble regulating blood pressure, and~     suffer impaired cardiovascular regulation from their injury. In addition, we've recently~     reported deficits in blood flow to the brain at rest and during cognitive tests; with results~     being further impaired in SCI with chronically low blood pressure. Therefore the goals of~     this project are to determine the influence of cardiovascular and cerebral vascular responses~     at rest and during cognitive testing on test performance in 80 individuals with SCI compared~     to 50 age-matched non-SCI controls. All potential subjects will undergo a rigorous two-part~     screening process which consists of an initial screening via telephone and a detailed,~     in-person screening. Eligible subjects will be invited to participate in a 3 hour laboratory~     visit during which their arterial stiffness, blood pressure, heart rate, respiration rate~     and, blood flow to the brain will be monitored at rest and during a comprehensive series of~     cognitive tests.~      We hypothesize that blood pressure and cerebrovascular response to testing will account~     significantly for performance in cognitive testing that otherwise would have been~     attributable to SCI status.~   "
110354|NCT02122978|"~     Increasing research evidence supports the effectiveness of mindfulness based interventions;~     however, the exact mechanisms of change are poorly understood. Some evidence proposes that~     self-compassion is an important mechanism of change in the effectiveness of mindfulness based~     interventions. The current research will evaluate and compare the effectiveness of two~     mindfulness meditation approaches; Mindfulness Based Cognitive Therapy (MBCT) and Mindfulness~     based Self-compassion Therapy (MBSCT), for individuals with psoriasis, a skin condition~     commonly associated with stress. Blood analyses will be conducted to assess and compare the~     impact of the interventions on the immune system. Self-report questionnaires will explore~     participants' psychological functioning (e.g. self-compassion, depression, anxiety, worry).~     This study will also examine whether a relationship exists between immune functioning and~     psychological factors. An audio-guided MBSCT programme will be piloted, with a view to~     trialling as a more cost-effective alternative to traditional mindfulness interventions.~     Findings will enable us to design more effective interventions in the future, and yield clear~     results regarding the existence of a definite link between immunological functioning and~     psychological functioning.~      The main research hypothesis is that participants who complete a mindfulness based~     intervention will experience significantly greater psychological well-being, symptom~     reduction, and greater changes in telomerase and cytokine activity than individuals who only~     receive treatment as usual for their psoriasis.~   "
110355|NCT02122965|"~     Adverse drug events are unintended and harmful events related to medication use and a leading~     cause of emergency department visits, unplanned hospital admissions and deaths. In the~     emergency department, physicians frequently misdiagnose adverse drug events leading to~     treatment delays. Our objective is to evaluate the effect of pharmacist-led medication review~     in high-risk emergency department patients on prolonged hospital stay.~      This prospective multi-centre, quasi-randomized study is nested within an existing quality~     improvement program. Triage nurses flag incoming emergency department patients at high-risk~     for adverse drug events by applying a clinical decision rule consisting of four variables~     (co-morbid conditions, antibiotic use within 7 days, medication changes within 28 days, and~     age). Consecutive eligible high-risk patients are enrolled into the medication review study,~     and systematically allocated to pharmacist-led medication review or usual care. In the~     intervention group, medication review pharmacists collect best-possible medication histories,~     review the patient's medications for appropriateness and adverse drug events, and communicate~     the results of medication review to patients, caregivers and physicians. In the usual care~     group, physicians refer patients to onsite pharmacists for medication management questions on~     an as needed basis. Health outcomes are assessed using anonymized data linkage to~     administrative health databases. The primary outcome is the percent of days spent in hospital~     during the first 30 days after the index emergency department visit~   "
110356|NCT02122952|"~     The purpose of this trial is to evaluate safety and efficacy of intravenous delivery of~     AVXS-101 as a treatment of spinal muscular atrophy Type 1 (SMN1).~   "
110357|NCT02122939|"~     An Open-label, single dosing clinical trial to investigate the pharmacokinetics and the~     effect on ECG of escitalopram after oral administration in elderly volunteers.~   "
110358|NCT02122926|"~     The goal of this study is to design and implement an intensive discharge intervention for~     inpatients with type 2 diabetes and cardiovascular disease, and determine the effects of the~     intervention on post-discharge insulin adherence, glycemic control, cardiac medication~     adherence, hypoglycemic events, and emergency department visits and hospital readmissions.~   "
110359|NCT02122913|"~     This is a multicenter, open-label, Phase 1 study of orally administered larotrectinib in~     adult subjects with advanced solid tumors and a NTRK1, NTRK2, or NTRK3 gene fusion that have~     progressed or are non responsive to available therapies and for which no standard or~     available curative therapy exists.~   "
110360|NCT02122900|"~     The primary objective of this study is to determine the reasons for balloon aortic~     valvuloplasty (BAV) in the current clinical setting and to determine the outcomes of BAV in~     patients with aortic stenosis. The ultimate aim is to establish the safety, effectiveness,~     and appropriate role of BAV therapy as definitive therapy (palliation) or as a bridge to~     surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR).~   "
110361|NCT02122887|"~     The investigators expect an intervention that focuses on actual dialogue and familiarity with~     members of the other culture, discussion of empathy, generosity, and kindness, and focus on~     adaptive and reciprocal modes of conflict resolution will alter both physiological,~     behavioral, and mental response to the pain of the other, increase empathy, and reduce~     hostility.~   "
110362|NCT02122874|"~     Percutaneous neurostimulation of dermatome T7 increases Insulin segregation by the apancreas~     and improves glycemic profile in diabetic patients~   "
110420|NCT02122120|"~     Home enteral nutrition (HEN) has always been recognized as a life-saving procedure, but with~     the ongoing economic crisis influencing health care, its cost-effectiveness has been~     questioned recently.~      Objective: The unique reimbursement situation in Poland enabled the otherwise ethically~     unacceptable, hence unavailable, comparison of the period of no-feeding and the long-term~     feeding and the subsequent analyses of the clinical value of the latter and its~     cost-effectiveness.~   "
110363|NCT02122861|"~     This is a Phase 1 multi-center study to evaluate the clinical safety and immune response of~     ID-LV305 when injected intradermally in patients with advanced cancer. ID-LV305 is a novel~     immunotherapy agent designed to target dendritic cells and stimulate the body's immune system~     to fight the spread and growth of cancer for patients whose tumors express the NY-ESO-1~     protein. Patients with melanoma, sarcoma, ovarian cancer, or small cell lung cancer that~     express NY-ESO-1 may be considered for the trial. Selected sites will be evaluating ID-LV305~     with pembrolizumab for patients with melanoma who have inadequately responded to anti-PD-1~     therapy.~   "
110364|NCT02122848|"~     The purpose of this study is to evaluate the effects of airway bilevel positive pressure on~     the improvement of exercise tolerance in patients with decompensated heart failure.~   "
110365|NCT02122835|"~     The purpose of this study is to understand the differences in how patients with heart failure~     respond to exercise training compared to patients with heart failure and type 2 diabetes.~   "
110366|NCT02122822|"~     RATIONALE: heat shock protein gp96-peptide complex made from a person's tumor cells may help~     the body build an effective immune response to kill tumor cells.~      PURPOSE: This trial is studying the safety and effectiveness of autologous gp96 treatment of~     glioblastoma and to see how well it works in treating patients with newly diagnosed~     supratentoria glioma.~   "
110367|NCT02122809|"~     The purpose of this dose-escalation study is to assess the safety and tolerability of~     treatment with Chiauranib administered orally over a range of doses in patients with advanced~     solid tumors.~   "
110368|NCT02122796|"~     The purpose of the study is to compare the effect of acupuncture to the standard of care~     (control group) on pain, nausea, anxiety, ability to cope, costs and length of hospital stay~     in post-mastectomy patients at Abbott Northwestern Hospital.~   "
110369|NCT02122783|"~     The purpose of this study is to evaluate how two different settings of a commercially~     available ankle foot brace affect how stroke patients walk. The study brace is an ankle foot~     orthosis (AFO) that makes use of a newer type of joint that contains a soft insert, in~     addition to the conventional hard stops, to limit the range of motion of the ankle during~     walking. The results of this study will help to clarify 1) whether and how this new joint~     affects the way you walk, 2) whether it makes it easier for the clinician to align your brace~     and 3) your opinions about the new joint.~   "
110370|NCT02122770|"~     The primary purpose of this study is to assess the effect of multiple-dose administration of~     fluconazole on the single-dose intravenous (IV) pharmacokinetics (PK) of MLN4924; and to~     assess the effect of multiple-dose administration of itraconazole on the single-dose IV PK of~     MLN4924.~   "
110371|NCT02122757|"~     Anodal tDCS increases the excitability of the cerebral cortex and its daily application~     during intercritical phase, may have a therapeutic effect in episodic migraine.~   "
110372|NCT02122744|"~     Evaluation of inhibiting rTMS QP over the visual cortex for the prevention of chronic~     migraine. The aim of the study is to confirm that inhibiting rTMS QP is capable to decrease~     the frequency of migraine and if its effect is stronger than placebo effect.~   "
110373|NCT02122731|"~     To evaluate the antihypertensive effect of amiloride added to triple antihypertensive therapy~     in patients with resistant hypertension (RH) and type 2 diabetes mellitus (T2DM)~   "
110374|NCT02122718|"~     Recurrent stroke and cognitive decline are common after ischaemic stroke. Allopurinol, a drug~     usually used to treat gout, has been shown to reduce heart ischaemia, heart size, and~     arterial stiffness and to relax brain blood vessels and may reduce the blood pressure. All of~     these properties may be associated with a lower risk of second stroke and cognitive decline.~     We now aim to explore whether allopurinol will reduce further damage to the brain (called~     white matter hyper-intensities) after stroke and also whether it reduces heart size and blood~     pressure after stroke.~      We will conduct a multi-centre randomised, double-blind placebo controlled study to~     investigate whether two years allopurinol 300 mg twice per day (BD) improves these 3~     outcomes, which are inextricably linked to risk of recurrence and cognitive decline after~     ischaemic stroke.~   "
110375|NCT02122705|"~     This study is a prospective case series aiming to evaluate a new VPIA remifentanil algorithm~     which would benefit labouring mothers who are unable or unwilling to receive epidural~     analgesia.~   "
110376|NCT02122692|"~     To examine the effect of the strong CYP3A4/5 inhibitor itraconazole (200 mg QD) on the~     multipledose exposure of Lu AE58054 (30 mg QD) in healthy subjects (CYP2D6 extensive~     metabolisers).~   "
110377|NCT02122679|"~     Tranexamic acid is a relatively safe medicine that is used to help the body develop clots and~     slow down bleeding after large surgeries. While it has already been shown to work well in~     adults and older children, there is no information on whether it works, and how it works in~     children younger than 6 months old. The goal of our study is to try and understand whether~     and how tranexamic acid works in children younger than 6 months old who are having open heart~     surgery.~      We plan to study tranexamic acid by testing its effect when compared with a placebo. The~     investigators will use a method called randomization - which means patients who agree to be~     in the study will be entered into a computer. The computer will randomly assign them to~     either receive the medicine or the placebo. We will then compare effects on the 2 groups of~     patients. Our goal is to have 50 patients in each group, or 100 patients total. We will not~     know whether patients receive tranexamic acid or placebo until we review the data collected~     at the end of the study.~      Tranexamic acid is usually given to patients in the operating room during open heart surgery.~     During open heart surgery patients require cardio-pulmonary bypass which is a machine that~     replaces the function of the heart and lungs for a short period of time. This allows surgeons~     to do surgery on the heart itself without having to worry about it moving during the~     operation. The bypass machine has lots of tubes to carry the blood around it. When blood~     comes into contact with the tubing it has a tendency to clot. To prevent this patients are~     given a blood thinner called heparin. Although heparin prevents clotting in the bypass~     machine, it can also increase the risk of bleeding when the surgery is over. To reduce this~     risk patients are given another medicine at the completion of surgery called protamine to try~     and reverse the effect of the blood thinner, heparin.~      Even so bleeding remains a significant problem, especially for babies after open heart~     surgery. Being on the bypass machine and having a lot of suture (stitches) lines increase~     that risk. In addition, the bypass machine affects the function of platelets, the main~     component of the body's clotting system. We often have to replenish blood products after~     surgery to try and stop the bleeding. Some centers, including we , have used the medicine~     tranexamic acid to try and help with bleeding after surgery. There have been other studies~     that show it helps with fibrinolysis, which is another important part of the body's clotting~     system. However, that part of the clotting system is not well developed in infants and~     therefore likely does not play an important role in preventing bleeding in that age group.~      As such, it may be that tranexamic acid impacts platelet function as well, and it is that~     effect that helps decrease post-operative bleeding in infants younger than 6 months. This has~     not been previously studied. In order to study the effect that tranexamic acid has on~     platelets the investigators are proposing the investigators' research trial. The~     investigators plan to randomize patients to either receive tranexamic acid or placebo in the~     operating room as described above. The investigators will then draw a small amount of blood~     from each patient (total of approximately 1 tablespoon) and send it to a special lab for~     testing of platelet function. The lab test will help us understand whether the platelets~     function better when patients receive tranexamic acid instead of placebo.~      The investigators will also be monitoring other outcomes related to platelet function. These~     will include how much bleeding patients have after surgery when they are in the intensive~     care unit, and how much blood products they require to treat that bleeding. The investigators~     will also monitor labs that are checked routinely in all patients after open heart surgery.~     The investigators will also track how long it takes each patient to get off the ventilator~     and how long they spend in the ICU after surgery. All of this data will help us understand~     whether tranexamic acid makes a positive impact on outcomes after open heart surgery in~     infants less than 6 months old.~      The current standard of care is quite variable within our institution as well as at other~     institutions. Some anesthesiologists use tranexamic acid while others elect not to. There is~     no definitive guideline to its current use. The dosing differs from center to center, and~     there are some centers that do not use it at all.~      The investigators' hope is that the results of this study will help us understand the role~     tranexamic acid plays in preserving the function of platelets after open heart surgery in~     young infants, and whether that impact translates into improved outcomes for those patients.~     Based on the results of our research we hope to develop definitive guidelines for the use of~     tranexamic acid in the population of infants <6 months old undergoing open heart surgery.~   "
110378|NCT02122666|"~     The investigators previous research has suggested that lipid (fatty) composition in the~     muscle cells of mice plays a key role in their insulin sensitivity. The purpose of this study~     is to determine whether these specific fat signatures translate to humans by comparing the~     muscle of healthy patients to those with pre-diabetes, or the metabolic syndrome.~   "
110379|NCT02122653|"~     Muscle strength and endurance are important indexes of fitness. The muscle strength is the~     most important single predict factor of functional ability in aged frail individuals. Frailty~     related muscle weakness and fatigue are adapted from the pre-frail stage. Finding the~     contributions of the central and the peripheral factors to the deficits of muscle fitness and~     developing an effective muscle fitness training program for pre-frail individuals are very~     important.~      The muscle weakness and fatigue can be categorized into peripheral or central causes. The~     central fatigue and voluntary activation failure originate from the decrease in motivation or~     the reduction of the conduction within corticospinal tracts. Long term activation failure and~     central fatigue will cause disuse of muscle and result in peripheral weakness and peripheral~     fatigue. Studies found the selective type II fiber atrophy in aged people and this finding~     was different from the type I atrophy in conventional immobilization models. It is possible~     that the activation failure leads to the recruitment failure of high threshold type II fibers~     at the pre-frail stage. Quantifying the weighting of central versus peripheral factors~     contributing to the exercise limitation in pre-frail people is important.~      Most of the conventional strength and endurance training programs are based on the researches~     of young groups. These programs are not able to prevent people become frail. It is possibly~     that, due to the limitation of central fatigue, the pre-frail individuals stop exercise~     before the effective intensity being achieved. Almost no training program has been design for~     enhancing the voluntary activation level and relief the central fatigue. Seeking an~     appropriate training program to enhance central activation at the pre-frail stage is very~     important for preventing people become frail.~      Previous studies have shown that increasing afferent input by peripheral electrical~     stimulation (ES) at sensory threshold enhanced the plasticity of contralateral primary~     sensory cortex, the excitability of corticospinal tracts, and the functional performance in~     young adults. ES, which is easy to quantify the dose of afferent input, is a feasible method~     to be used in training. Combining afferent input with strength training might be able to~     overcome the central activation failure and help recruit high threshold motor unit in~     pre-frail individuals.~   "
110457|NCT02121639|"~     The aim of the ProCAID study is to determine if the addition of the AKT inhibitor AZD5363 to~     docetaxel and prednisolone (DP) prolongs progression free survival (PFS) in Metastatic~     castration resistant prostate cancer to a degree worthy of further investigation~   "
143297|NCT01691651|"~     The purpose of this study is to associate the use of botulinum toxin type A for patients with~     keratoconus to demonstrate that tension eyelid has an important role in disease progression.~   "
110380|NCT02122640|"~     LUNG ULTRASOUND IN THE MANAGEMENT OF DISPNEIC PATIENTS IN EMERGENCY DEPARTMENT~      Introduction~      This is a prospective randomized trial realized in the Emergency Department of the University~     Hospital of Siena, Italy.~      Dyspnea is one of the most common causes worldwide of admission to the Emergency Department~     (ED) and acute heart failure (AHF) is a major cause of serious morbidity and death in such~     population, above all in elderly patients. Incidence rate is signiﬁcantly higher in men than~     in women, in Europe it increases with age from 1.4/1000 person-years in subjects aged 55-59~     years to 47.4/1000 person-years in those aged 90 years or older. The age-adjusted prevalence~     of AHF in the United States averages 36 cases per 100,000 of the population and accounts for~     10,000 deaths annually.~      In clinical practice this symptomatology is usually investigated in the pre-hospital phase~     only with history and physical examination; in the ED blood gas analysis (BGA), laboratory~     tests and chest X-rays can be performed as primary exams. BNP and NT pro-BNP are now~     considered reliable biochemical markers to distinguish cardiogenic from pulmonary etiology,~     both for their diagnostic and prognostic value. On the other hand, these biomarkers are~     affected by a grey zone of uncertainty, they are not available in all hospitals and their~     dosage samples are expensive: thus we propose other tools to support the diagnostic process.~   "
110381|NCT02122627|"~     Vitamin D has an immunomodulatory role. the aim of the present study is to assess the effect~     of vitamin D supplementation on exacerbation rate of COPD patient with a vitamin D~     deficiency.~   "
110382|NCT02122614|"~     The aim of this randomized controlled trial is to investigate the effects of adding PA~     monitoring and regular feedback of a pedometer (step counter) to an outpatient pulmonary~     rehabilitation (PR) program on daily PA levels and health status of patients with COPD.~      Patients will be randomized to either receive a PR program with PA monitoring and regular~     feedback of a pedometer (experimental group [EG]) or a PR program alone (control group [CG]).~     During the PR program, patients in the EG will receive a pedometer to self-monitor their PA~     and individualized step-count goals. They will continue to use the pedometers and receive~     individualized goals for 3 months after the program.~      It is expected that, by receiving individualized goals and a simple pedometer to self-monitor~     their PA during and after a PR program, patients with COPD will become more active and adhere~     to long-term rehabilitation, thus reducing the overall impact of COPD.~   "
110383|NCT02122601|"~     To assess the safety and efficacy of LBSA0103 (BDDE cross-linked sodium hyaluronate gel) when~     it is administered for the second time 26 weeks after its first administration in patients~     with osteoarthritis of the knee.~      The Safety and efficacy of 26weeks after its first administration will be also evaluated.~   "
110384|NCT02122588|"~     This is a multicentre, non-interventional, prospective study to be carried out in~     representative hospitals in order to assess 1st line treatment management and diagnostic~     approaches applied to ovarian, peritoneal and fallopian tube cancer management in Russia and~     assess patients` characteristics and the occurrence of BRCA (Breast Cancer gene) mutations~     among Russian women with serous and endometrioid ovarian, peritoneal and fallopian tube~     cancer. No additional procedures besides those already used in the routine clinical practice~     will be applied to the patients. Treatment assignment will be done according to the current~     practice.~   "
110385|NCT02122575|"~     Background:~      - Restricting calories can help a person reduce risk factors for heart disease. Researchers~     have found that not eating or drinking anything but water for 24 hours prevents the~     activation of a component of the immune system, called the inflammasome. The inflammasome is~     associated with the development of diabetes and heart disease. Researchers want to learn more~     about the body s response to fasting.~      Objective:~      - To explore the benefits of calorie restriction on heart health.~      Eligibility:~      - Healthy adults ages 21 32 with a body mass index between 26 and 29.~      Design:~        -  Participants will be screened with a medical history, physical exam and blood test.~        -  Participants will not eat or drink after 10 p.m. before their first visit.~        -  Participants have breakfast at the clinic. The breakfast will be about 500 calories.~          Then they will not eat or drink (except water) for 24 hours.~        -  Participants will return to the clinic the next morning. They will have blood drawn.~          Then they will have breakfast. Blood will be drawn again at 1 hour and 3 hours after the~          meal.~        -  Blood and urine tests at the end of the fast and following the meals will be done to~          confirm that participants have fasted for the full 24-hour period.~   "
110386|NCT02122562|"~     Objective:~      Glutamate-based medications including the N-methyl-D-aspartate (NMDA) receptor antagonist~     ketamine result in rapid, robust and sustained (up to one week) antidepressant effects in~     randomized controlled trials in treatment-refractory unipolar and bipolar depression.~     Previous work by our group has demonstrated that a family history of alcohol dependence~     predicts a more robust antidepressant response to ketamine in both treatment-resistant~     unipolar and bipolar depression.~      Recently-detoxified alcoholics and affected first-degree relatives display blunted~     psychotomimetic, cognitive and other neuropsychiatric effects with a subanesthetic dose of~     ketamine. Also, a family history of alcoholism alone predicts differential response to~     intravenous alcohol. Based on our prior post hoc results, we seek to prospectively~     demonstrate that a family history of alcohol dependence predicts a more robust antidepressant~     response to ketamine. We will also explore potential biomarkers of ketamine s antidepressant~     effects in treatment-refractory depressed patients at risk of alcohol dependence (using~     physiological and neurochemical responses to alcohol).~      Study Population:~      21-65 year old treatment-resistant major depressive disorder without psychotic features~     patients in a current major depressive episode of at least moderate severity will be~     recruited and enrolled in this protocol. All subjects must also be free of a lifetime~     substance use disorder diagnosis with the exception of a nicotine or caffeine use disorder)~     and will be psychotropic medication-free for at least two weeks prior to the first alcohol~     infusion. Our targeted number of completers will be 50 depressed subjects (60 signing consent~     to account for attrition): 25 FHP subjects [as defined by either one first degree relative or~     two second-degree relatives with alcohol dependence on the Family Interview for Genetics~     Studies (FIGS) and Family Tree Questionnaire (FTQ)] and 25 FHN negative subjects.~      Design:~      This study is a single-site, open-label protocol in psychotropic medication-free depressed~     subjects admitted to the Clinical Research Center s Mood and Anxiety Disorder Inpatient~     Research Unit (7-SE). This protocol consists of two phases (Phase I and Phase II). The first~     phase consists of the medication taper and drug-free period. The second phase will have three~     subphases: Subphase IIA ( alcohol clamp infusion #1 with neurophysiological assessments), IIB~     ( alcohol clamp infusion #2 during 7 Tesla-Magnetic Resonance Spectroscopy/Imaging~     (7T-MRS/I)) and IIC (subanesthetic/antidepressant dose ketamine infusion during 7T-MRS/I).~      Outcome Measures:~      The primary hypothesis/outcome measure will be change in mean Montgomery-Asberg Depression~     Rating Scale (MADRS) total score from the pre-ketamine infusion baseline-to-7 days~     post-infusion between the FHP and FHN groups. Other exploratory measures include~     neurophysiological responses to intravenous alcohol infusion, brain neurochemical alterations~     during intravenous alcohol infusion, brain neurochemical alterations during intravenous~     ketamine infusion and resting state (task-free) functional magnetic resonance imaging as a~     function of family history of an alcohol use disorder.~   "
110387|NCT02122549|"~     This study will obtain device-human interaction evaluations for the HWD1000 within the~     controlled environment of the hospital as well as establish that the safety profile is~     similar to outpatient wearable cardioverter-defibrillators use.~   "
110388|NCT02122536|"~     The aim of this prospective, randomized, double-blind, intraindividual split face study will~     be to compare onabotulinumtoxinA to incobotulinumtoxinA for the correction of facial wrinkles~     using a 1:1 dose ratio.~   "
110389|NCT02122523|"~     The sentinel lymph node (SLN) procedure is a standard staging technique in several types of~     cancer. One of the major problems of SLN mapping in colorectal cancer is the lack of an~     optimal dye and technique for identification of the nodes. In this study the investigators~     used the Near-Infrared (NIR) dye Indocyanin Green (ICG) to identify nodes with a newly~     developed NIR laparoscope. The investigators compared two different injection techniques;~     subserosal and submucosal injection.~      Patients planned for a laparoscopic resection of a colorectal carcinoma without distant~     metastases were included. Dye was injected in the subserosa or submucosa of the bowel. Ten~     minutes after injection the investigators searched for fluorescent nodes with the NIR~     laparoscope. Fluorescent nodes were harvested and analyzed by the pathologist using H&E and~     additional immunohistochemistry.~   "
110390|NCT02122510|"~     In this study, the investigators will compare the analgesic effect of bupivacaine and~     bupivacaine-dexmetomedine after elective cesarean delivery by performing an bilateral TAP~     block, on the patients for whom the operation will be performed under general anesthesia.~   "
110466|NCT02121522|"~     The present trial will use an open label design to investigate the effect of BI 144807 on~     central 1-mm retinal thickness and presence of neovascular leakage in newly diagnosed wAMD~     patients. A further objective is to collect data on adverse events, vital signs, ECG and~     clinical laboratory parameters of BI 144807 in the same patient group.~   "
110391|NCT02122497|"~     The aim of the present study is the evaluation of cardiovascular biomarkers in patients with~     abdominal aortic aneurysms (AAA) or abdominal aortic occlusive disease AOD) undergoing open~     (OR) or endovascular aortic repair (EVAR) with regards to short- and long-term outcome.~      By blood collection and measurement of the serum biomarkers Copeptin, N-terminal- pro Brain~     Natriuretic Peptide (NT-proBNP), cardiac Troponin I (cTnI), high sensitive Troponin T~     (hs-cTnT) and C-reactive Protein (CRP) we expect an improvement of patients stratification by~     assessment of cardiac stress tolerance. Data gathered may help to simplify the decision~     whether an open or endovascular approach for abdominal aortic repair (OR and EVAR) should be~     performed.~      Study Hypothesis:~      The evaluation of the predictive value of cardiovascular biomarkers (Copeptin, NT-proBNP,~     hsTnT, cTnI, CRP) improve patient stratification and selection of surgical treatment.~   "
110392|NCT02122484|"~     There is evidence that inflammatory processes may play a key role during surgical myocardial~     reperfusion. The hypothesis of this study is that colchicine, an anti-inflammatory agent, may~     lead to reduction in periprocedural infarct size, when administered during elective coronary~     artery bypass graft surgery.~   "
110393|NCT02122471|"~     The purpose of this study is to confirm that the investigational medication, plecanatide, is~     safe and effective in treating chronic idiopathic constipation.~   "
110394|NCT02122458|"~     The purpose of this study is to study blast-exposed Veterans who report hearing handicap but~     show normal or near normal results on standard audiometric testing. The characteristics and~     nature of their auditory and auditory-related skills will be examined, along with whether~     coexisting PTSD contributes to the hearing problems of these Veterans. In a preliminary~     treatment study, a sub-sample of these Veterans will be fitted with mild-gain hearing aids to~     determine if they benefit from low-level amplification of high-frequency sounds.~   "
110395|NCT02122445|"~     Low back pain is a problem which affects up to 70-80% of people in their lifetime. In the~     United States, it is estimated that the total direct and indirect costs of low back pain~     combined ranges from $19.6 to $118.8 billion. Recent studies have shown the importance of the~     gluteal musculature in the treatment of low back pain. It was found that the gluteus maximus~     (Gmax) is significantly more active in a low back pain population compared to a healthy~     population, indicating the low back pain population relied on the Gmax to fire more to~     overcome the gluteal weakness. A new approach to treating musculoskeletal conditions is a~     taping technique designed to target muscles and lymphatic system. Limited research is~     available for the treatment of specific conditions, including low back pain, but it is~     theorized to inhibit or facilitate the muscle, improve blood flow, reduce pain, and improve~     joint alignment. Methods: The purpose of this study is to determine the immediate and delayed~     effectiveness of Cramer® Sports Motion Tape on Gmax and lumbar paraspinal activation in a~     chronic mechanical low back pain population. A convenience sample of 20 new patients with~     current, chronic low back pain, no current neurologic signs or symptoms, no previous spinal~     surgery, no corticosteroid treatment within the last two weeks, and who are not pregnant will~     be recruited for this study. Patients will sign an informed consent, complete all initial~     paperwork. Surface electromyography will be used to quantify the activity level of the Gmax~     and lumbar paraspinals (LP). The MVIC will be estimated for each muscle group and the patient~     will perform a series of 4 randomized exercises, 5 repetitions each; Clams with Resistance,~     Standing Hip Abduction with Resistance, Sidelying Hip Abduction, and a forward bend. After~     each exercise the patient will rate How hard they are working on the RISE scale. Following~     the initial test, Cramer® Sports Motion Tape will be applied to the gluteal and low back~     area. After the tape is applied, the EMG exercise protocol will be repeated. The tape will be~     left on until the patient returns for their next appointment, within 24 to 48 hours, where~     they will have a delayed post-test. Patients will rate their pain, surface electrodes will be~     applied to the previous testing sites, and MVIC will be retested for each muscle group. The~     patient will perform the same protocol that was performed in the initial testing session. The~     EMG signals will be smoothed, rectified and analyzed using a root-mean-square algorithm. The~     investigators will use visual onset and offset of the EMG signal amplitude to select the~     middle 3 trials. Average activation and peak activation will be determined and compared to~     the MVIC for each muscle group, and expressed as a %MVIC. This will allow %MVIC to be~     compared and rank order among groups and muscles.~   "
110396|NCT02122432|"~     In France, there is usually a long delay (approximately 6 weeks) before a general~     practitioner can obtain a specialized advice by dermatologists for diagnosis of unusual~     dermatologic conditions of their patients.~      Previous studies have shown that teledermatology is a reliable way for diagnosis in~     dermatology.~      We hypothesize that a teledermatology advice could reduce delay before diagnosis and~     therefore treatment for patients.~   "
110397|NCT02122419|"~     We aimed to investigate the association between the position in which spinal anesthesia was~     performed and postdural puncture headache occurrence.~   "
110398|NCT02122406|"~     The primary endpoint of this study is to evaluate the prevalence of anxiety and depressive~     disorders, and their relationship with disease activity, in patients with rheumatoid~     arthritis treated with biological drugs~   "
110399|NCT02122393|"~     Th purpose of this study is to determine whether dual psychological and pharmacological~     treatment is superior to either mono-therapy alone in the treatment of postnatal depression.~   "
110400|NCT02122380|"~     Adults with abdominal obesity are at high risk for cardiovascular disease and also exhibit~     diminished growth hormone (GH) secretion; the latter further contributes to the development~     of visceral adiposity, impaired fibrinolysis and inflammation.Growth hormone releasing~     hormone (GHRH), the primary stimulus for endogenous GH secretion, is a substrate of~     dipeptidyl peptidase 4 (DPP4); inhibition of DPP4 with the currently available anti-diabetic~     therapy, sitagliptin, may therefore increase GH secretion by decreasing the degradation of~     GHRH. The proposed research will test the hypothesis that chronic sitagliptin therapy will~     enhance GH secretion and vascular function while improving glucose tolerance in patients with~     impaired GH secretion who are at risk for the development of diabetes mellitus and~     cardiovascular disease, specifically obese women with polycystic ovary syndrome.~   "
110401|NCT02122367|"~     Appropriate indices to guide fluid therapy are essential for effective hemodynamic management~     during the perioperative period. Values derived from respiratory changes in arterial pressure~     waveform or plethysmographic waveform such as stroke volume variation and pleth variability~     index have been demonstrated to be able to predict fluid responsiveness in surgical or~     critically ill patients. Their ability to predict fluid responsiveness can be affected by~     factors that influence the arterial tone or the compliance of the respiratory system by~     position change. The aim of this prospective trial is to investigate the ability of stroke~     volume variation and pleth variability index to predict fluid responsiveness in the reverse~     trendelenberg position.~   "
110467|NCT02121509|"~     The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose~     combination (FDC) tablet containing linagliptin and metformin extended release compared to~     the free combination of linagliptin and metformin extended release.~   "
112367|NCT02096666|"~     This is a multicenter, Phase 1/2 study. The study will evaluate the tolerability, safety and~     activity of AMG 337 in Asian subjects who have advanced solid tumors (Phase 1) or subjects~     with MET amplified tumors with a focus on gastric/gastroesophageal junction/esophageal~     adenocarcinoma (Phase 2).~   "
110402|NCT02122354|"~     The objective of this research is the accumulation of gameplay data and simulator sickness~     background surveys for trend analysis, and individual simulator sickness trigger factor~     analysis for the test subjects involved. Rather than isolating specific variables for~     hypothesis formulation, this study will be attempting to collect an array of data that is a)~     both qualitative and quantitative, and b) observational and test subject-reported. The final~     results will consist of a list of possible trigger factors to avoid for individual subjects,~     and metrics showing the directional tendencies of players depending on the severity of their~     symptoms at the time.~      The overall goal of this research is to better understand factors that contribute to~     simulator sickness, both in who it affects and why some gameplay experiences may cause it~     more than others. Operating from the basic assumption that the way a player moves through an~     environment affects how quickly that player gets sick, we will primarily be gathering data on~     how the player moves through the digital space and whether that behavior changes once they~     begin to feel sick.~   "
110403|NCT02122341|"~     The purpose of this clinical study is to evaluate BackStop, a polymer-based device that is~     intended to be used during ureteroscopic lithotripsy to prevent retrograde stone migration.~   "
110404|NCT02122328|"~     The investigators hypothesize that treatment of twin-twin transfusion syndrome (TTTS) using~     sequential laser photocoagulation of communicating vessels (SQLPCV) over the predominant~     method, selective laser photocoagulation of communicating vessels (SLPCV), may provide~     vascular stability to the donor fetus. The primary objective is to evaluate the perinatal~     outcome, specifically, donor intrauterine survival of TTTS managed by SQLPCV vs. SLPCV in a~     prospective, randomized trial.~   "
110405|NCT02122315|"~     Fractures of the proximal humerus account for between 5% and 8% off all reported fractures.~     Post-operative shoulder pain is highly frequent. Due to either surgical procedure, soft~     tissues surrounding the shoulder area can be damaged. The purpose of the current clinical~     trial was to compare the effects of physiotherapy versus physiotherapy plus TrP-DN on pain~     and function in patients who exhibit post-operative shoulder pain after a PHILOS procedure~     for proximal humeral fixation or rotator cuff tear repair.~   "
110406|NCT02122302|"~     This investigation develops an online, patient self-assessment system, called CarePrep to~     support the care and clinical research of patients with chronic pancreatic disease and~     chronic pancreatic pain. This web-based assessment presents patients with questions that~     address medical, psychological, social, behavioral, and quality-of-life issues that are~     relevant to pancreatic disease. Patients will be given the opportunity to enter and track~     their symptoms over the Internet from home or clinic. The system is also designed to gather~     clues to identify neuropathic pain, which occurs when the nervous system fails to properly~     regulate pain signals. Any of these factors can contribute to chronic pain and may point the~     way to more effective treatment. The broad objective of this study is to extend CarePrep to~     cover a full range of topics that are relevant to chronic pancreatic disease. The study team~     will refine this content based on the system's accuracy in real clinical settings and direct~     efforts to maximize its feasibility.~   "
110407|NCT02122289|"~     Exacerbation in cystic fibrosis play an important role in terms of mortality and morbidity.~     Exacerbation frequencies is relatedto FEV1 decline and mortality. There is a relationship~     between exacerbation frequency and QoLdeterioration. Moreover exacerbation treatments present~     health costs burden leading to important physical psychological and social impact. Preventing~     exacerbation and early detection of these exacerbations may decrease intensity and freqauency~     of exacerbation leading to increase clinical status and QoLwith a decreased health cost.~      Patients actually follow in CRCM track exacerbations when visits out patient clinic and~     during phone call. If patients did not call or did not present regularly to out patient~     clinic, exacerbation detection came later and so increasde the burden and therapeutic~     pressure.~      The objective of our study is to identify earlier the potential exacerbations and so~     decreased the health costs and increased the patient's QoL. Forthis purpose we propose to use~     modern technologiessuch as smartphone in order to create alert when patients report weekly~     health satatus. We will compra patients randomize in control group with standart follow-up to~     patients randomize in the smartphone group.Moreover we will study the compliance and~     satisfactory degree of the use of this device in the interventional arm.~   "
110408|NCT02122276|"~     In animal and human studies, histochemical and physiological evidences showed that the muscle~     transferred from slow, fatigue-resistant muscle to fast, fatigable muscle after spinal cord~     injury. The alternation of muscular property was accompanied by the alternation of spinal~     circuitry property, and was related to the immobilization adaptation. Previous study showed~     that remobilization by continuous passive motion (CPM) for one month would restore the~     function of spinal circuitry in individual with chronic SCI. It is possible that long term~     application of CPM can reverse the adaptation of contractile properties of the paralyzed~     muscle after SCI. The purpose of this study is to investigate the effect of a four month CPM~     training on muscular properties in individuals with chronic SCI.~   "
110409|NCT02122263|"~     To evaluate the effect of Bariatric surgery on the extent of liver fat and liver fibrosis and~     on different metabolic parameters in patients undergoing sleeve gastrectomy surgery.~   "
110410|NCT02122250|"~     This project will address vital questions regarding how best to design web-based materials~     for the growing population of patients with basic literacy and computer skills but lower~     levels of health literacy, building on our previous experience of developing web-based~     materials for people with lower levels of literacy and health literacy.~      This study will be carried out two phases. Phase 1 will use qualitative methods to understand~     user experiences of the web-based materials through observational 'think-aloud' interviews~     with users. Phase 2 will test the newly developed web-based materials to a static~     (non-interactive) version of the materials online.~   "
110411|NCT02122237|"~     Cathodal tDCS decreases the excitability of the cerebral cortex and its daily application~     during intercritical phase, may have a therapeutic effect in chronic migraine.~   "
110480|NCT02121340|"~     In this feasibility/pilot study, we will develop, refine, and evaluate the feasibility of a~     novel mental health/ophthalmologic intervention called, Collaborative Care for Depression~     and Diabetic Retinopathy (CC-DDR), which aims to treat depression and lower HbA1C in older~     African Americans with mild-to-moderate diabetic retinopathy (DR) and comorbid depression.~   "
110412|NCT02122224|"~     One important factor determining school performance is the consumption of breakfast. While~     research has shown that older children perform better in school after consuming breakfast,~     there are little data for preschool-age children. Consuming breakfasts with different macro-~     and micronutrient contents may have different effects on performance, which may be associated~     with variations in satiation and satiety during and after the different breakfasts. In~     addition, children who consume breakfast have better diet quality than children who skip~     breakfast.~      The investigators will conduct a community based, randomized, crossover trial in 4-5 year old~     children over 7 weeks to examine the short-term effect of feeding preschoolers three~     different intervention breakfast types: high protein, high-fiber, or high protein and high~     fiber compared to a usual breakfast served at the preschool. The investigators expect that~     the children consuming any of the three experimental breakfasts will consume less overall~     calories and have better diet quality and memory performance compared to children who have~     the usual breakfast. The investigators hypothesis is that preschoolers will experience the~     highest level of satiety as well as highest level of overall diet quality when they consume~     the combined high-protein and high-fiber based breakfast foods.~      This study will be conducted at Bauer Family Resources in Lafayette as these are the sites of~     Head Start programs, which are preschools for children from low-income families. Children~     from families of low income are more likely to have poor diet quality and poor school~     performance compared to children from families with higher incomes. Therefore, this~     population is most in need of this type of intervention.~   "
110413|NCT02122211|"~     The ability of sperm to swim is important for normal fertility. Men with a genetic variation~     in the gene coding for Choline Dehydrogenase (CHDH) have decreased energy production by~     sperm, and their sperm do not swim normally. The metabolic product of this gene is a nutrient~     called betaine (found normally in the diet as a part of many foods such as spinach, beets and~     grain products). This study tests whether treatment with betaine is safe and whether it can~     normalize energy production in sperm of these men and restore normal swimming ability.~   "
110414|NCT02122198|"~     Complaints about memory and thinking are common in women as they go through menopause and~     estrogen levels fall. The ovarian hormone estrogen is important for supporting normal~     cognitive function, and changes in brain activity and function occur when estrogen levels are~     decreased. Estrogen is also important for maintaining healthy blood vessels which also~     support normal cognitive function. In Alzheimer's disease and other types of dementia, there~     is significant damage to the blood vessels in the brain. This study will test whether changes~     in brain activity and function with the loss of estrogen are related to changes in vascular~     function. The investigators will measure vascular function using ultrasound, and brain~     activity using MRI scans in women who are enrolled in the Females, Aging, Metabolism and~     Exercise (FAME) study (NCT01712230). In the FAME study, healthy premenopausal women either~     take a medication to decrease their estrogen levels, or a placebo. This sub-study may provide~     new information about how estrogen affects vascular function and cognitive function, and lead~     to new ways to prevent or delay cognitive impairment or dementia.~   "
110415|NCT02122185|"~     This randomized phase II trial studies how well metformin hydrochloride and combination~     chemotherapy works in treating patients with stage III-IV ovarian, fallopian tube, or primary~     peritoneal cancer. Drugs used in chemotherapy, such as carboplatin, paclitaxel and docetaxel,~     work in different ways to stop the growth of tumor cells, either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading. Metformin hydrochloride may~     help carboplatin, paclitaxel and docetaxel work better by making tumor cells more sensitive~     to the drugs. Studying samples of blood and tissue in the laboratory from patients receiving~     metformin hydrochloride may help doctors learn more about the effects of metformin~     hydrochloride on cells. It may also help doctors understand how well patients respond to~     treatment. Giving metformin hydrochloride together with combination chemotherapy may kill~     more tumor cells.~   "
110416|NCT02122172|"~     This phase II trial studies how well afatinib dimaleate works in treating patients with~     urothelial cancer that cannot be removed surgically and has grown after treatment with~     standard first-line chemotherapy. Afatinib dimaleate may turn off the function of the~     epidermal growth factor (EGF) and human epidermal growth factor receptor 2 (HER2) receptors,~     which may slow the growth of cancer cells or cause some of the cells to die.~   "
110417|NCT02122159|"~     Pathologic myopia is a major cause of legal blindness worldwide. In myopic macular~     degeneration (MMD), there is degeneration of the retinal pigment epithelial (RPE) layer, and~     associated photoreceptors, resulting in vision loss. There is currently no standard treatment~     for MMD.~      Transplantation of intact sheets of RPE and suspensions of isolated individual RPE cells as~     well as autologous translocation of RPE cells has been attempted as treatment for AMD. Human~     photoreceptors are comprised of two cell types-rods and cones. Both have a close relationship~     with the outermost retinal cells, the retinal pigmented epithelium (RPE). The RPE is located~     between the choroid and the photoreceptors. The RPE maintains photoreceptor function by~     recycling photopigments,delivering, metabolizing and storing vitamin A, phagocytosing rod~     photoreceptor outer segments, transporting iron and small molecules between retina and~     choroid, maintaining Bruch's membrane and absorbing stray light to allow better image~     resolution. In essence, the RPE layer is critical to the function and health of~     photoreceptors and the retina as a whole.~      Human PRE (hRPE) transplantation may be a viable option for treatment of degenerative~     diseases of the retina.~      MA09-hRPE cells are fully differentiated human RPE cells derived from embryonic stem cells.~     Transplanted hRPE cells prepared by Advanced Cell Technology have been studied in rodent~     models of macular degenerative disease. The data suggests that the subretinal injection of~     ACT's hRPE cell products rescues, or at least delays, loss of visual function in two animal~     models of retinal degenerative diseases.~      The main purpose of this study is to evaluate the safety and tolerability of MA09-hRPE~     cellular therapy in patients with Myopic Macular Degeneration (MMD). Another objective is to~     evaluate potential efficacy endpoints to be used in future studies of RPE cellular therapy.~   "
110418|NCT02122146|"~     To assess the safety and tolerability at increasing dose levels of PF-06664178 in patients~     with advanced solid tumors in order to determine the maximum tolerated dose and select the~     recommended Phase 2 dose.~   "
110419|NCT02122133|"~     The primary objective of this study is to gather data on the radiation exposure in patients~     treated with the Penumbra Coil 400™ System (PC 400) or conventional coils per their~     respective indications for use.This is a multicenter case review study of patients presenting~     with intracranial aneurysms who are treated with coil embolization therapy using the PC 400~     or conventional coils. Data for each patient are collected acutely.Up to 90 patients treated~     with the PC 400 or conventional coils (2:1) at up to 15 centers in the USA will be enrolled.~   "
113329|NCT02084043|"~     Using an adult lung bench model of non invasive ventilation, the aim of the study is to~     compare an experimental system of breath-synchronized vibrating mesh nebulizer to a~     conventional vibrating mesh nebulizer during non invasive ventilation in terms of inhaled and~     lost doses.~   "
110421|NCT02122107|"~     In this study,the investigators are looking to see how older women who are survivors of~     breast cancer and either did or did not receive chemotherapy are affected by treatment,~     compared to older women who have never had cancer. Thinking and memory abilities normally~     decrease with age and the investigators want to see if the long-term effects of cancer~     treatments may make these problems worse. The investigators will also look at how thinking~     and memory abilities of older women are affected by genetics and smoking history. Genetics~     and other factors may affect the brain's chemicals or structure, and may either protect~     against the negative effects on thinking or make someone more at risk for them.~   "
110422|NCT02122094|"~     This study seeks to implement a sexual health promotion intervention for male sex workers in~     Hanoi and Ho Chi Minh City, Vietnam. The study hypothesis is that this intervention will~     increase testing, treatment and vaccination for sexually transmitted infections, including~     intentions of participants to engage in these services beyond the conclusion of the~     intervention. At the community level, the study hypothesis is that male sex workers will be~     more aware of sexual health care and more likely to access these services in the future.~   "
110423|NCT02122081|"~     This pilot clinical trial aims to assess feasibility and tolerability of using an LINAC based~     organ-sparing marrow-targeted irradiation to condition patients with high-risk~     hematological malignancies who are otherwise ineligible to undergo myeloablative Total body~     irradiation (TBI)-based conditioning prior to allogeneic stem cell transplant. The target~     patient populations are those with ALL, AML, MDS who are either elderly (>50 years of age)~     but healthy, or younger patients with worse medical comorbidities (HCT-Specific Comorbidity~     Index Score (HCT-CI) > 4). The goal is to have the patients benefit from potentially more~     efficacious myeloablative radiation based conditioning approach without the side effects~     associated with TBI.~   "
110424|NCT02122068|"~     Family dementia caregivers provide a needed service to relatives with dementia and to~     society, but are often at risk for consequences to their own health such as depression,~     reduced immune system function, and burnout. Central Meditation and Imagery Therapy (CMIT) is~     a novel group mindfulness and guided imagery intervention designed to help caregivers reduce~     depressive symptoms and cope with the stress of caregiving. A small study suggested that CMIT~     techniques are feasible for dementia caregivers, and resulted in a reduction of depressive~     and anxiety symptoms. The largest benefits were shown to occur within the first 4 weeks, and~     were maintained at 3 months post treatment. The early benefits of CMIT were further described~     in a recent trial of CMIT for patients with recurrent depression, which demonstrated~     promising improvement in depressive symptoms, with the largest benefits occurring within the~     first 4 weeks. We have therefore shortened CMIT for caregivers from 8 weeks to 4 weeks, and~     aim to study the effects of the four-week version (Central Meditation and Imagery Therapy,~     Short Term, CMIT-ST) on dementia caregivers with elevated depressive symptoms. We will~     conduct a pilot feasibility of CMIT-ST versus home relaxation practice with 24 dementia~     caregivers. Half of the caregivers will be randomly assigned to receive a relaxation~     recording, while the other half will receive CMIT-ST. After 4 weeks, the group assigned to~     the relaxation recording will then have the opportunity to participate in CMIT-ST.~      To measure the effects of CMIT-ST, we will obtain depression symptom ratings and~     questionnaires about psychological symptoms before and after CMIT-ST. We will also study the~     biological effects of CMIT-ST. We will do so by measuring brain activity, recording the pulse~     in order to determine variation in beat to beat intervals of the heart, and studying patterns~     of gene expression.~   "
110425|NCT02122055|"~     For the patient who passed the screen of weaning from ventilation, the traditional sedation~     drug such as propofol and midazolam should be decreased or stopped, then it would induce the~     stress response and agitation, such as hypertension,tachycardia etc. In order to resolve that~     problem, the sedation should be given again. but if renewed to sedation, it would cause~     prolonged sedation and ventilation duration.~      So as to resolve above issues, after the patient passed the screen of weaning, sedation is~     changed to Dexmedetomidine, a new sedation drug, that could wake up at any time. So our study~     to compare the efficacy and safety of sequential sedation of propofol or midazolam and~     dexmedetomidine in mechanical ventilated ICU patients.~   "
110426|NCT02122042|"~     The aim of the current study is to evaluate, in a prospective cross-over, randomized study,~     the effect of hyperbaric oxygen therapy (HBOT) on patients with chronic impairment after low~     grade glioma tumor removal surgery~   "
110427|NCT02122029|"~     The purpose of the current study is to determine whether an intensive lifestyle intervention~     was as effective as surgery to treat morbid obesity nine years post-intervention.~   "
110428|NCT02122016|"~     Mechanical ventilation is widely used for ICU patients as a lifesaving procedure. However, it~     is associated with several complications, such as ventilator-associated pneumonia and the~     increase of hospital morbidity and mortality. To avoid such complications, we need to wean~     these patients off the ventilator as soon as possible. This must however be done at the right~     time to avoid other complications, such as the need for re-intubation. For this reason, it is~     important to have a specific weaning protocol, which will reduce the time on mechanical~     ventilation, and avoiding the need for re-intubation and other complications. Recently, an~     argument has developed as to which weaning protocol would be more appropriated, and whether a~     computer driven weaning protocol could have better results than the conventional weaning~     protocols focusing on daily screening and daily interruption of sedation followed by a~     spontaneous breathing test. Our objective is to compare mechanical ventilation times, weaning~     success up to 48 hours after extubation, re-intubation rates between a group with computer~     driven weaning protocol (SmartCare) versus a weaning protocol with daily weaning screens and~     spontaneous breathing trials in ICU patients ventilated for more than 24 hours.~   "
110429|NCT02122003|"~     -  Retrospective studies showed Sorafenib's efficacy as second line treatment after a~          Tyrosine Kinase Inhibitor (TKI).~        -  Currently there is no standard of treatment in 2nd line for patients treated in first~          line with pazopanib for metastatic Renal Cell Carcinoma (mRCC).~        -  With this trial we evaluate the efficacy of sorafenib as second line of treatment in~          patients treated with pazopanib for mRCC.~   "
110430|NCT02121990|"~     The purpose of this study is to test the safety of the drug olaparib at different dose~     levels. It will be given with the standard initial chemotherapy for cancer as well as a drug~     called bevacizumab.~   "
110431|NCT02121977|"~     The aim of this study is to further evaluate the safety and efficacy of the Elevate® Anterior~     and Apical Prolapse Repair System for repair of anterior/apical pelvic organ prolapse in a~     controlled, post-market cohort study.~   "
110496|NCT02121132|"~     The main objective of this study is to establish a national pediatric obesity registry known~     as POWER (Pediatric Obesity Weight Evaluation Registry). This registry will contain clinical~     data from individual comprehensive pediatric weight management programs around the United~     States for overweight and obese youth.~   "
113330|NCT02084030|"~     The aim of this study is to perform a whole-genome linkage analysis for identification of the~     susceptibility loci for POCD~   "
110432|NCT02121964|"~     In this prospective, randomized study, investigators will look at the outcome of total hip~     arthroplasty through the anterior approach in regard to the surgical treatment of the~     anterior hip capsule. At this time, there are 2 different techniques: one is excising this~     capsule and the second one is cutting the capsule and repairing it at the end of the~     procedure. The investigators set out to determine whether incising or repairing the capsule~     will benefit the patients in terms of postoperative pain level, range of motion of the hip~     joint, joint stability, surgical time and blood loss. Both preserving and excising the joint~     capsule are accepted techniques in performing total hip arthroplasty. The Investigators~     hypothesize that capsulectomy may allow for reduction in operative time, provide superior~     surgical exposure, and increased range of motion after surgery. The influence on post~     operative pain and dislocation rate is unknown.~   "
110433|NCT02121951|"~     Percutaneous nephrostomy (PCN) is one of the interventions in the radiology department in~     which pain control is necessary. Quadratus Lumborum (QL) block will be tried to limit the use~     of systemic analgesics and its accompanying untoward effects in those frail patients~     requiring PCN that is performed in the prone position.~   "
110434|NCT02121938|"~     The purpose of the study is to describe the dynamics of the microbiome in the premature~     infant as a means to adapt the premature infant gut to affect better health outcomes.~   "
110435|NCT02121925|"~     This registry is intended to measure the effect of myPlan Lung Cancer™ test has on treatment~     decisions of Surgeons when added to standard clinical-pathological parameters in patients~     with early stage NSCLC.The sponsor is conducting two parallel registries, with one directed~     at Surgeons (ONC003) and the other at Oncologists (ONC006).This registry is specific to~     Surgeons (ONC003). Outcomes measures on lung cancer relapse and death from any cause will be~     collected.~   "
110436|NCT02121912|"~     Participants will undergo a normal sleep study. They will be randomised to use either a FPH~     Pilairo Q nasal pillow CPAP mask, or another mask. The sleep technician will record leak and~     pressure data, and complete questionnaires regarding satisfaction and ease of use at the end~     of the night. It is hypothesised that the Pilairo Q mask will be superior to other standard~     masks for CPAP therapy in terms of ease of use, satisfaction and overall titration~     experience.~   "
110437|NCT02121899|"~     This registry is intended to measure the effect of myPlan Lung Cancer™ test has on~     influencing treatment decisions of Oncologists when added to standard clinical-pathological~     parameters in patients with early stage NSCLC.~      The sponsor is conducting two parallel registries, with one directed at Surgeons (ONC003) and~     the other at Oncologists (ONC006). This registry is specific to Oncologists (ONC006).~   "
110438|NCT02121886|"~     To evaluate the safety and outcome of the parietal peritoneum for venous reconstruction HPB~     surgery. Although the parietal peritoneum had already been used and published for the~     reconstruction of the vena cava, however this one was never described or described in HPB~     surgery~   "
110439|NCT02121873|"~     The objective of this study is to determine whether we can use minimally invasive techniques~     to gain access to exfoliated ductal epithelial cells for whole genome sequencing.~        1. To examine women with nipple aspiration, ductoscopy and ductal lavage and collect~          exfoliated cells from two ducts per woman.~        2. To collect a blood sample at the time of the examination in order to obtain the woman's~          baseline genomic sequence.~        3. De-identified samples will then have DNA and RNA extracted and whole genome sequencing~          and transcriptome analysis performed by Covance and Illumina.~        4. Comparisons will be made within a breast (two ducts) and between the duct and blood as~          well as between women.~   "
110440|NCT02121860|"~     This is an open-label, parallel-group study to compare the pharmacokinetics and~     pharmacodynamics of IDN-6556 following a single 50 mg oral dose of IDN-6556 in subjects with~     mild, moderate, and severe hepatic impairment (defined as Child-Pugh A, B, and C,~     respectively) and matched healthy volunteers with normal hepatic function.~   "
110441|NCT02121847|"~     This study will evaluate the safety and efficacy of cyclosporine 0.05% ophthalmic emulsion~     (Restasis®) in patients with dry eye disease.~   "
110442|NCT02121834|"~     This is a multiple dose study of LY3050258 in healthy men and postmenopausal women. This~     study will evaluate the safety and how well the body tolerates LY3050258. It will last~     approximately 14 weeks with a 2 week follow-up appointment after the last treatment with~     study drug.~   "
110443|NCT02121821|"~     The study aims to assess the effects of the SMS Mother Reminder system on use of health care~     in Uganda. A secondary aim of the study is to determine the behavioral factors and~     cost-effectiveness, as well as test the usability of the SMS Mother Reminder in Uganda.~   "
110444|NCT02121808|"~     The risk of complications associated with airway management in obese patients is significant.~     The results of pre-oxygenation allow a prolonged non-hypoxic apnea time for the clinician.~     The increase in FRC and non-hypoxic apnea time is correlated. The best condition to~     accomplish the pre-oxygenation in morbidly obese patient is still undetermined in medical~     literature.~      This study is designed to evaluate the effect of different positions combined with different~     ventilation modes during the pre-oxygenation phase of anesthesia's induction. EPO2: PV will~     evaluate the effect of different combinations of positions and ventilation modes on pulmonary~     volumes (mainly functional residual capacity) in a morbidly obese volunteer.~   "
110445|NCT02121795|"~     This study will evaluate the efficacy of switching from emtricitabine/tenofovir disoproxil~     fumarate (FTC/TDF) fixed dose combination (FDC) to emtricitabine/tenofovir alafenamide~     (F/TAF) FDC in HIV-1 positive participants who are virologically suppressed on regimens~     containing FTC/TDF.~      This study will consist of a 96 week double-blind treatment period. After Week 96, all~     participants will continue on blinded study drug treatment and attend visits every 12 weeks~     until treatment assignments are unblinded. All participants will return for an unblinding~     visit and will be given the option to receive open-label F/TAF and attend visits every 12~     weeks until F/TAF is commercially available, or the sponsor terminates the F/TAF clinical~     development program.~   "
110508|NCT02120976|"~     The purpose of this study is to evaluate the safety, tolerability, and PK of single oral~     doses of JTT-252 and the effect of food on the PK of JTT-252 in healthy subjects, and to~     evaluate the safety, tolerability, PK and PD of single oral doses of JTT-252 in type 2~     diabetes mellitus subjects.~   "
110509|NCT02120963|"~     Aim: To study if a person-centered physical therapy intervention program contributes to~     diminished fatigue in people with Rheumatoid Arthritis (RA).~   "
110446|NCT02121782|"~     The purpose of this study is to determine whether GC3110A (a QIV) is effective compared to GC~     Flu Pre-filled Syringe Inj. (a marketed TIV) after single intramuscular administration in~     Korean healthy adults.~      The comparator, GC Flu pre-filled syringe inj. is a trivalent influenza vaccine (TIV)~     including viruses representing 3 influenza strains (one A/HIN1, one A/H3N2, and one B).~     However, two antigenically distinct lineages of influenza B (Victoria and Yamagata)~     co-circulate annually in the United States. Predicting which lineage of influenza B will~     predominate during a season is challenging, and cross-protection by immunization against the~     other lineage is expected to be low. One proposed alternative is to produce a quadrivalent~     influenza vaccine (QIV) including an influenza B virus from each of the two circulating~     lineages. GC3110A is a new quadrivalent influenza vaccine (QIV), which contains all of 4~     vaccine components WHO recommends for use in the 2013-14 influenza season (northern~     hemisphere winter) and includes two influenza B viruses. GC3110A is expected to show the~     additional public health benefit compared with traditional TIV.~   "
110447|NCT02121769|"~     Omegaven is an intravenous fat emulsion (IFE) comprised of omega-3 fatty acids derived from~     fish oil. It will be used in an open label compassionate use treatment protocol, as an~     alternative to soybean oil (omega-6), as the sole IFE source of parenteral nutrition in an~     effort to reduce and/or reverse parenteral nutrition associated liver disease. The study will~     evaluate the safety and efficacy of Omegaven use in pediatric patients with PN dependence and~     PNALD.~   "
110448|NCT02121756|"~     The purpose of this study is to determine if Dipyridamole (DP) will decrease inflammation in~     HIV-1-infected individuals who are already on antiretroviral treatment and have a low viral~     load.~   "
110449|NCT02121743|"~     In France around 5,000 colostomies are performed after elective or emergency surgery. These~     colostomies could be associated with major outcomes including parastomal hernia (4 - 53%) of~     cases.~      To reduce the incidence of these outcomes, several methods have been proposed but the more~     pertinent consist in the use of a biological mesh during the stoma's conception.~      Nevertheless there is no data on the use of a biological mesh (StratticeTM) for the~     prevention of parastomal hernia.~   "
110450|NCT02121730|"~     Kidney transplantation is now the treatment of choice for end-stage renal disease (ESRD).~     Between 2800 and 3000 kidney transplants are performed each year in France and more than 33~     000 patients are living with a functioning graft.~      Preventing allograft rejection requires the use of immunosuppressive therapy, the intensity~     decreases as the distance from the day of transplantation. Unfortunately, treatment favors~     certain complications, including infectious and neoplastic. These represent a major cause of~     mortality in these patients. If the frequency of skin cancer is greatly increased in this~     population, that of solid tumors remains a concern. Approximately 20% of patients develop~     cancer after 10 years of graft , half non- skin cancers, the main risk factor is~     immunosuppressive therapy .~      The aim of the study is to evaluate, in a large population of patients treated in 4 regions (~     the Nord-Pas de Calais, the Upper and Lower Normandy and Picardy) risk factors (in particular~     the nature of the immunosuppressive treatment) of developing a neoplastic complication, skin~     cancers and solid tumors, after renal transplantation.~   "
110451|NCT02121717|"~     The purpose of this study is to evaluate the efficacy and safety of Chiglitazar, compare with~     placebo.~   "
110452|NCT02121704|"~     Magnetic Endoscope Imaging (MEI) is an optional tool which can be switched on at the~     beginning of colonoscopy. MEI works by creating an electromagnetic field of very low~     intensity. By that the position of the endoscope can be displayed virtually on a monitor. The~     use of MEI has been shown to reduce the formation of loops and to ease the removal of~     existing loops during the investigation. Furthermore, as loops favour the occurrence of pain~     when the scope is moved forward, patients who underwent colonoscopy with MEI reported less~     pain at the end of the procedure.~      Sedation is used widely during colonoscopy for it has improved the tolerability of the~     investigation. Most of the patients demand for sedation. In Germany Propofol is recommended~     as the first-line sedative when endoscopy it is performed in an outpatient setting. The use~     of Propofol involves the danger of respiratory complications. One reason for the application~     of Propofol doses is the occurrence of pain during the investigation. We hypothesized that if~     MEI is used and if loops can be avoided sufficiently lower Propofol doses would be needed. We~     therefore planned this prospective controlled trial.~   "
110453|NCT02121691|"~     The project will target two behavioral causes of obesity: a sedentary lifestyle and an~     unhealthy diet. The goal is to test a faith-based intervention among men and women who are~     members of participating Appalachian churches.~      The primary hypothesis being tested in this project is: The change in body mass index from~     baseline to one year follow-up in intervention churches will be greater than among comparison~     churches, such that the differential change will be negative on average.~   "
110454|NCT02121678|"~     Resistance and aerobic exercise has been shown to be effective for maintenance of muscle~     strength in patients with neuromuscular diseases.~      Exercise in CIDP and MMN is sparsely described. The aim of the study is to evaluate changes~     in muscle strength during high intensive resistance training and changes in maximal oxygen~     consumption (VO2-max) during high intensive aerobic training in patients with CIDP or MMN in~     maintenance therapy with subcutaneous immunoglobulin.~      The hypotheses are that muscle strength and VO2-max are significantly increased during the~     training sessions.~   "
110455|NCT02121665|"~     Periodontal disease is an infectious disease resulting in inflammation within supporting~     tissues of the teeth, progressive attachment loss, and bone loss. Epidemiological studies~     reveal that about 10% of the adult population suffer from severe periodontitis.It comprises~     of two distinct but interconnected etiologic components: the periodontopathic bacteria~     adjacent to the periodontal tissues, and the host-mediated connective tissue-destructive~     responses to the causative bacteria and their metabolic products. In the arena of~     periodontics, the probiotics pose a great potential of plaque modification, halitosis~     management, altering anaerobic bacteria colonization, improvement of pocket depth, and~     clinical attachment gain.~      Aim of the study is to analyze the beneficial effect of probiotic lozenges as an adjunct to~     Scaling and Root Planing, on clinical and biochemical parameters.~   "
110456|NCT02121652|"~     The purpose of this study is to determine whether cognitive behavioral therapy (CBT) is~     effective for insomnia in lung cancer survivors.~   "
110458|NCT02121626|"~     The aim of the study is to identify how often gastrointestinal problems interfere with~     quality of life as a result of treatment for cancer with chemotherapy. We also want to~     identify the causes for these symptoms and see if simple treatments used for other~     gastrointestinal conditions could make chemotherapy an easier experience. Chemotherapy for~     cancer can be hard work for the patient. Often it makes them feel tired. Not infrequently, it~     can cause a whole range of physical side effects. Probably the most common side effects are~     those affecting the stomach and bowels. Vomiting used to be a major problem with chemotherapy~     but research discovered a whole series of new treatments so that severe vomiting from~     chemotherapy is rarely a problem today. However, patients can develop a whole series of other~     symptoms during chemotherapy, for example, bloating, wind, diarrhoea, needing to rush to the~     lavatory and opening the bowels very frequently. The causes for these symptoms have hardly~     been studied even though they sometimes affect people quite badly. In our specialist~     gastrointestinal clinic at the Royal Marsden Hospital, over the last 12 years, we have~     pioneered new methods for dealing with symptoms which affect the bowel after radiotherapy. We~     would like to extend these methods to people having chemotherapy. We have identified several~     easily treatable causes for these symptoms after radiotherapy, which previously were often~     ignored. We believe that some of these causes also occur in people having chemotherapy and if~     we knew how often they do occur we could focus on improving treatment for affected people. We~     plan to find out how often 40 stomach and bowel symptoms occur during chemotherapy. In people~     who are troubled by any or some of these symptoms we will arrange simple series tests which~     could sort out why these symptoms occur and we will record how they respond to treatment.~   "
110459|NCT02121613|"~     The aim of this study is to support the efficacy of Permixon 160 mg b.i.d. in treating~     subjects with symptomatic Benign Prostatic Hyperplasia (BPH), compared to placebo, using~     Tamsulosine LP 0.4 mg as a reference treatment.~   "
110460|NCT02121600|"~     Evaluate the ability of 18F-FCH PET/MRI scan to detect pre-treatment tumor burden and assess~     response to treatment in men with castration resistant prostate cancer (CRPC).~      It is hypothesized that these novel biomarkers will better identify evaluable lesions prior~     to therapy and identify response to treatment (or lack thereof) earlier in the treatment~     period, providing a better guide for treating men with CRPC.~   "
110461|NCT02121587|"~     The purpose of this pre and post intervention observational study is to evaluate~     patient-reported outcomes from an new clinical course which integrates Mindfulness and~     Acceptance-based approaches from '3rd wave' Cognitive Behavioural Therapy with osteopathic~     manual therapy treatment for patients with persistent pain.~      It is being conducted by the British School of Osteopathy (BSO) in London. In Stage 1 (in~     progress, June 2013 to August 2014), a course was developed for self-referring patients~     attending the BSO Clinic. In Stage 2 (September 2014 to May 2016), delivery will be expanded~     to evaluate outcomes for patients attending National Health Service (NHS) General~     Practitioner (GP) surgeries in South East London.~      The intervention consists of a pre-course screening interview; a structured course of six,~     weekly, one-hour treatment sessions for individual patients; and an optional follow-up~     interview after three months.~      The evaluation study is being conducted by an independent study team from the National~     Council for Osteopathic Research. Patients complete a set of standardised questionnaires~     before the course and after six months to assess self-reported changes in quality of life,~     well-being, activity levels, mindfulness and use of health resources. A sample of patients~     will be invited to provide consent for a treatment session to be observed and/or recorded, or~     to attend a follow-up interview after six months, to evaluate the quality of course delivery.~     This is an observational study of patient-reported outcomes from a new intervention in a~     single cohort of patients, so there is no formal study hypothesis but it is anticipated that~     outcomes will include increased quality of life, well-being, and active engagement with~     valued activities.~   "
110462|NCT02121574|"~     Background When a patient is anesthetised and undergoes an operation, their body temperature~     falls. Managing a body temperature properly by keeping it within normal limits has been shown~     to improve recovery from surgery.~      A vital part of managing temperature is being able to measure it properly. There are several~     ways of doing so, which consist of invasive methods such as temperature probes in the~     oesophagus and bladder, and non invasive methods such as infrared scanners and ear canal~     probes. During an operation, temperature changes as small as 0.5 °C can affect outcomes but,~     currently, only invasive methods are reliable enough to detect this. Oesophageal probes can't~     be used in patients who are not anaesthetised during their operations, and it is~     inappropriate to insert a urinary catheter should it not be otherwise needed.~      The purpose of this study is to look at two new methods of measuring a patient's temperature~     which would help us in these situations. The first is called zero-flux thermometry and~     involves placing an adhesive pad to the forehead, which gives constant measurement of a~     patient's core temperature. The second involves swallowing an ingestible capsule that is no~     bigger than a normal pill. This technique has been very useful in research tracking a~     patient's core temperature as they are transferred through different areas over a longer~     period of time. Whilst these two methods are potentially very useful, they have never been~     tested on hospital patients.~      Aims:~      The investigators want to determine whether readings from these thermometers are accurate~     enough to be used in patients before, during and after surgery. Should they prove to be~     sufficiently accurate it will allow us to improve patient care through both clinical practice~     and research.~      Plan:~      During operations, temperature is routinely measured in line with NICE guidelines with a~     thermometer placed in the nose or oesophagous. The investigators will not be changing routine~     practice in any way, but checking measurements from the new devices against the proven,~     routine ones.~      The investigators plan to record measurements from each device every minute throughout the~     operation in 20 patients. The investigators will then perform statistical tests to check~     their accuracy.~      Study Hypothesis: Zero flux and ingestible thermometers are not significantly different at~     detecting patients body temperature than oesophageal temperature probes~   "
110463|NCT02121561|"~     When people feel shame, they experience negative thoughts about themselves (I'm a bad~     person) and urges to avoid others. Shame is related to many psychological problems, such as~     depression, social anxiety, and borderline personality disorder (BPD). Because there are~     currently no well-tested treatments for shame, this study will examine the utility of~     Self-Acceptance Group Therapy (SAGT). SAGT is short-term group therapy that addresses shame~     specifically. Changes in shame, mood, and behavior will be examined over the course of~     treatment and a one-month follow-up.~      Based on theory and existing evidence, Hypothesis 1a is that individuals with elevated~     initial levels of shame will report improvements on all outcome measures (e.g., reductions in~     trait shame, increases in self-acceptance) from pre-treatment to post-treatment, and~     Hypothesis 1b is that these gains will be maintained at follow-up one month after treatment~     completion.~   "
110464|NCT02121548|"~     Caribbean immigrants (both Hispanics and Blacks from Haiti) are less likely to be screened~     for cervical cancer than the general population. One promising approach is outreach~     strategies that employ Community Health Workers (CHWs). Yet even in well structured CHW~     programs, many women remain unscreened. In our NCI Community Networks sponsored project, we~     are testing an approach that combines CHWs with self sampling for the human papilloma virus~     (HPV) as a screening strategy among such hard to reach populations.~   "
110465|NCT02121535|"~     The study will be performed as an open-label, randomised, single-dose, two-sequence,~     four-period replicated crossover design. A total of 72 Japanese healthy male subjects will be~     randomised to 2 groups. The subjects are administrated either T80/A5/H12.5 mg FDC tablet once~     or T80/A5 mg FDC tablet and hydrochlorothiazide (HCTZ) 12.5 mg tablet once in each period.~     The length of admission will be 7 days in each period.~   "
143298|NCT01691638|"~     (A retrospective case control study to validate the association between Interleukin-1 gene~     variations and adult chronic periodontal disease in European Caucasians)~   "
110468|NCT02121496|"~     1. Investigators aim to assess a novel behavioral intervention (currently approved in~          Protocol #6285) behavioral intervention that promotes maternally-mediated behavioral~          changes in young infants to reduce the risk of postpartum depression in a group of low~          income women. More specifically, investigators aim to determine if a behavioral~          intervention targeting maternal caregiving of young infants can increase infant sleep~          and reduce fuss/cry behavior and thereby: (1) reduce the incidence and/or severity of~          postpartum maternal depression in low socioeconomic status (SES) women, and (2) improve~          the quality of mother-infant interaction and subsequent child development. Investigators~          will study:~             1. The feasibility of applying this protocol with a low SES population~             2. The effectiveness of the intervention compared to usual care~             3. If the effects of the intervention can be detected in assessments of the quality of~               mother-infant interaction and infant neurocognitive development~        2. Investigators aim to determine whether this behavioral intervention can affect infant~          development as measured by neurodevelopmental assessments and cortisol reactivity at 4~          months of age.~   "
110469|NCT02121483|"~     The aim of the study is to generate pharmacokinetic and pharmacodynamic data to identify the~     safe-effective dose of empagliflozin in children and adolescents aged 10 to less than 18~     years with type 2 diabetes mellitus.~   "
110470|NCT02121470|"~     Acute Kidney Injury (AKI) is a common and severe complication in critically ill patients~     which is associated with increased morbidity and mortality as well as high costs of medical~     care.~      NGAL (neutrophil gelatinase-associated lipocalin, lipocalin-2, siderocalin) is a biomarker,~     that is expressed in several tissues including the kidneys. Renal expression of NGAL is~     dramatically increased in kidney injury from a variety of causes, and NGAL is released into~     both urine and plasma. NGAL levels rise within two hours of the insult, making NGAL an early~     and sensitive biomarker of kidney injury, with the potential to assist clinicians in managing~     patients at risk of kidney injury.~      This study is designed to validate the assigned NGAL cutoff value by comparing to clinical~     diagnosis of AKI as determined by current clinical practice in the US.~      The study sites will enroll consecutive ICU patients. Patients are given standard clinical~     care and lab-work. Each day, one additional urine and two additional plasma samples will be~     drawn and frozen. These additional samples are shipped to Sponsor for retrospective NGAL~     measurements.~      The duration of each subject´s participation will be until discharge from the ICU, or for a~     maximum 8 days, whichever comes first. In addition serum creatinine values will continue to~     be collected manually from the hospital data system for 48 hours after discharge from the~     ICU. (If subject has been in ICU for 8 or more days, the follow up values are collected while~     the patient is still in the ICU).~      250 subjects will be enrolled in total at the three investigator sites. At least 40 patients~     must be enrolled at each site.~      The NGAL value will be matched to the clinical diagnosis of acute kidney injury (AKI) as~     specified by KDIGO® guidelines. The clinical diagnosis will be assigned by a three-person~     adjudication panel based on the entries in the eCRF by the investigators. Adjudicators are~     blinded for investigation site, AKI-diagnosis by treating physician, and NGAL values.~      A comparison of AKI diagnosis based on the cutoff value 250 ng/mL and clinical diagnosis as~     assigned by the majority of the adjudication panel will be conducted.~   "
110471|NCT02121457|"~     Some studies reported that selenium status is associated with cognitive function. However~     only a few reports have investigated whether selenium supplementation can benefit cognitive~     performance and in most of them selenium supplementation was not exclusive. Also, none of~     those reports have used foods rich in selenium as a source of supplementation. Thus, the aim~     of our study was to investigate whether the consumption of Brazil nuts improves cognitive~     function. We hypothesized that the daily consumption of Brazil nuts would have benefits on~     selenium status, increase antioxidant enzyme activity and improve cognitive function in older~     adults with MCI.~   "
110472|NCT02121444|"~     This study aims to investigate adherence to therapy among patients treated with Betaferon who~     are using the BETACONNECT autoinjector.~   "
110473|NCT02121431|"~     This trial addresses a serious and all-too-frequent public health problem, namely early-onset~     disruptive behavior problems in young children. The focus is on testing an online treatment~     program which empowers parents to help their children to improve their mental health and~     behavioral functioning. At the conclusion of the study, the investigators will know whether~     the online-delivered program works as well as an established staff-delivered program, with~     respect to child disruptive behavior problems, parenting, parent/family stress, consumer~     satisfaction, and value analysis.~   "
110474|NCT02121418|"~     This clinical trial studies decitabine and cytarabine in treating older patients with newly~     diagnosed acute myeloid leukemia, myelodysplastic syndrome that is likely to come back or~     spread to other places in the body, or myeloproliferative neoplasm. Drugs used in~     chemotherapy, such as decitabine and cytarabine, work in different ways to stop the growth of~     cancer cells, either by killing the cells or by stopping them from dividing. Giving~     decitabine and cytarabine may work better than standard therapies in treating cancers of the~     bone marrow and blood cells, such as acute myeloid leukemia, myelodysplastic syndrome, or~     myeloproliferative neoplasm.~   "
110475|NCT02121405|"~     The purpose of this study is to determine whether primary radiotherapy can be omitted for the~     locally advanced rectal cancer with Magnetic Resonance Imaging (MRI) negative circumferential~     margin.~   "
110476|NCT02121392|"~     The purpose of this study is to further investigate the efficacy of adductor canal nerve~     blocks for pain management after total knee replacement. Specifically we are studying~     adductor canal nerve blocks in conjunction with epidural anesthesia, which is a combination~     that has not been extensively researched before. Our question is whether combining these~     modalities will enhance patient satisfaction after surgery and accelerate patients' readiness~     to discharge.~   "
110477|NCT02121379|"~     Pulmonary rehabilitation might be benificial in advanced lung cancer patients with COPD who~     undergo cytotoxic chemotherapy.~      We will compare two groups, 8 week pulmonary rehabilitation group and usual care group.~   "
110478|NCT02121366|"~     The present study aims to evaluate the feasibility, safety and efficacy of EUS-guided ethanol~     ablation of an insulinoma.~   "
110479|NCT02121353|"~     The aim of this study is to test if PF582 (ranibizumab) is safe and similar to Lucentis~     (ranibizumab). Participants will have a screening visit to check for eligibility. Eligible~     participants will receive either PF582 or Lucentis, by injection into one eye on study Day 1,~     28 and 56. Visits will be conducted on Day 2, 7, 14 80 and at 6 and 12 months. During the~     study participants will undergo the following procedures: height, weight and vital signs~     (blood pressure, pulse, temperature, breathing rate) measurement; medical and surgical~     history and concomitant medications; adverse event monitoring; physical examinations; eye~     tests (reading chart, measurement of retinal thickness [via pictures of the retina] and~     examination of the eye's blood vessels, via pictures taken following injection of a dye into~     the arm), blood collection and a urine pregnancy test, where applicable.~   "
143327|NCT01691261|"~     Phase 1 trial of retinal pigment epithelium replacement in subjects with wet age-related~     macular degeneration in whom there is rapidly progressing vision loss~   "
110481|NCT02121327|"~     It has been reported that stroke is the first cause of becoming bedridden, and its cumulative~     recurrence rate in 5 years is approximately 35%. There is a high probability that patients~     reduce or discontinue medications by self-determination, leading to a high risk of stroke~     recurrence in these patients. Comprehensive and long-term patient educations ameliorating~     their self-management are important making patients possible to be managed according to the~     guidelines for their risk factors. Using disease management programs created for each of risk~     factors according to clinical practice guidelines, the influence of those programs were~     evaluated for the prevention of stroke recurrence in this Disease Management Program Stroke~     Trial.~   "
110482|NCT02121314|"~     WHO recommends to take TB drugs while fasting: if TB drugs are taken with food, perhaps drug~     concentrations are too low; on the other hand: if this is not tolerated, drugs could also be~     taken with food.~      Do lower drug concentrations - with improved adherence to therapy - outweigh the disadvantage~     of lower drug blood concentrations over time? How exactly do the drug concentrations over~     time (pharmacokinetics) compare between fasting and fed conditions, especially in the early~     stage of TB treatment when patients are relatively sick, and relatively poorly tolerate TB~     drugs?~   "
110483|NCT02121301|"~     The purpose of this study is to evaluate whether SkQ1 ophthalmic solutions are safe and~     effective compared to placebo for the treatment of the signs and symptoms of dry eye~     syndrome.~   "
110484|NCT02121288|"~     The purpose of the study is to assess the effect of blood flow to the heart when subjects are~     treated with ticagrelor (Brilinta) or clopidogrel (antiplatelet drugs that stop the blood~     from clumping together) in patients with Peripheral Artery Disease (PAD).~   "
110485|NCT02121275|"~     Atelectases (collapsed lung areas) of 15-20% of total lung occur in up to 90% of patients who~     are anaesthetized and intubated. The goal of the present prospective study is to detect~     atelectatic areas in the perioperative period in the lungs of patients undergoing elective~     laparoscopic surgery non-invasively and without x-ray exposure. Results of lung ultrasound~     (LUS) as the experimental method will be compared to the results of Electrical Impedance~     Tomography (EIT) as the reference technique for the detection of atelectasis. A device for~     peripheral Oxygen saturation measurement (MASIMO Radical-8) will detect changes in~     ventilation. The investigators want to confirm or disprove former findings of the appearance~     of intraoperative atelectases and to prove that ultrasound is a valid tool for detection of~     atelectases.~   "
110486|NCT02121262|"~     This study will evaluate the safety and efficacy of 700 μg dexamethasone versus laser~     photocoagulation in patients with diabetic macular edema (DME).~   "
110487|NCT02121249|"~     The purpose of this study was to quantify potential short- and long-term benefits of~     robotically-guided minimally invasive spine surgery in instrumentation of degenerative lumbar~     or lumbosacral spine disease in adult patients, in comparison to instrumentation in a~     matching cohort of control patients performed using conventional freehand technique.~   "
110488|NCT02121236|"~     This is an in vivo study which aims to evaluate the diagnostic accuracy of ultrasonography in~     detecting benign radiolucent lesion in the both jaws. The ultrasonography-based diagnosis of~     contents will be compared to those findings obtained from the histological examination (i.e.~     the gold standard). The second part of this study will examine the measuring accuracy by~     comparing ultrasonography-based 3D measurements with those obtained from CBCT images of the~     lesion assuming that CBCT 3D measurements are the gold standard.~   "
110489|NCT02121223|"~     To evaluate the effective and safety of post-dilatation in patients with acute ST segment~     elevated myocardial infarction undergoing primary percutaneous intervention after thrombus~     aspiration assessed by optical coherence tomography to examine stent Incomplete apposition~     and strut coverage in patients treated with drug-eluting stents .~   "
110490|NCT02121210|"~     Primary Objective:~      To evaluate the immunogenicity of sarilumab administered as monotherapy.~      Secondary Objectives:~        -  To evaluate the other safety aspects of sarilumab administered as monotherapy.~        -  To assess the exposure of sarilumab administered as monotherapy.~   "
110491|NCT02121197|"~     To review the safety and efficacy of injections with Ozurdex (700 μg dexamethasone) in~     clinical practice management of patients with DME.~   "
110492|NCT02121184|"~     Fetal heart rate patterns are an important parameter in the diagnosis of non-reassuring fetal~     status. Combined-spinal epidural analgesia is a method of initiating labor analgesia used by~     approximately 90% of the parturients at Prentice Women's Hospital. Optimizing the variables~     which could affect fetal heart rate patterns at the time of initiation of analgesia, such as~     fluid administration and oxytocin management, could help us provide better care for our~     patients and their fetuses.~      Hypotheses: Patients who receive a 1000 mL fluid bolus and lower rates of oxytocin~     administration will have fewer non-reassuring fetal heart rate (FHR) changes.~   "
110493|NCT02121171|"~     The objective of this prospective randomised study is to compare the efficacy and safety of~     ologen CM (Collagen matrix) as adjunct to combined trabeculotomy-trabecuectomy in congenital~     glaucoma cases, the efficacy being the primary objective and the safety being the secondary.~     The investigators hypothesize that combined trabeculotomy-trabecuectomy with Ologen collagen~     matrix implant implantation in congenital glaucoma is a safer procedure and may yield better~     results than combined trabeculotomy-trabeculectomy approach.~   "
110494|NCT02121158|"~     The overall aim of this trial is to study the safety and efficacy of ICD implantation as a~     primary prevention strategy of sudden cardiac death in patients 70 years and older. This~     study will assess the many competing factors involved with ICD implantation including 1) the~     impact on mortality, especially in the context of a declining rate of sudden death with~     advanced age, 2) the tolerability of the powerful therapeutic action of the device, and 3)~     the impact on quality of life.~   "
110495|NCT02121145|"~     In a recent controlled study, the investigators explored cross-reactive immune responses~     against different Salmonella spp. in healthy volunteers immunized with either the oral~     (Vivotif® ) or parenteral (Typherix®) typhoid vaccines (ISRCTN68125331). In the present study~     immune responses will be studied in a group receiving both of these vaccines and in the~     previously immunized volunteers after booster immunization (same groups receive same vaccines~     2-4 years after primary immunization).~   "
110510|NCT02120950|"~     To collect data reflecting the efficacy and safety of aflibercept with and without~     photodynamic therapy in subjects diagnosed with the polypoidal choroidal vasculopathy subtype~     of wet age-related macular degeneration~   "
110497|NCT02121119|"~     In practice ambulatory orthopedic surgery, one of the problems of most difficult solution is~     adequate control of postoperative analgesia. Pain is a frequent cause of consultation and~     unscheduled readmissions in this group of patients.~      The use of continuous peripheral nerve blocks are an effective tool in postoperative~     analgesia.~      In this connection, most of the studies of continuous infusions of local anesthetics by~     perineural catheters have been made with bupivacaine, levobupivacaine, and ropivacaine~     However, it has been found that lidocaine action lasts less, has lower cost and is less toxic~     than longer-acting agents.~      The investigators aim is to compare the effectiveness of lidocaine versus bupivacaine~     continuous popliteal sciatic blockade ambulatory elastomeric pump.~   "
110498|NCT02121106|"~     With medication, many individuals with psychosis experience a remission from hallucinations~     and delusions, the most salient aspects of the disorders. However, alleviation of these~     symptoms is not associated with recovery of everyday functioning in important areas like~     working, socializing, maintaining the household, and recreational pursuits. The reason these~     difficulties with functioning persist is that psychotic disorders are associated with~     considerable difficulties with cognitive functions such as attention, memory, and planning.~     Cognitive impairments persist even when the delusions and hallucinations are treated, and in~     fact account for most of the persistent impairments in functioning.~      Recently, psychological treatments called Cognitive Remediation have been developed and~     tested in research settings, where techniques that train the brain to process information~     more efficiently result in very large improvements in cognition. However, there are two major~     hurdles remaining as investigators attempt to determine how this treatment can graduate from~     research laboratories to become a widespread clinical treatment. First, cognitive remediation~     in research settings is very intensive: it requires frequent visits with specialized~     therapists who deliver the treatment to groups of patients. This makes it quite difficult for~     people with psychosis, who might not have the financial means or motivation to travel and who~     might be experiencing symptoms that make it unlikely that they will attend groups, to~     participate fully if the traditional research techniques were directly transported to a~     clinical setting. The second hurdle is that even though cognitive remediation improves~     cognition, it does not always transfer to everyday behavior changes. Investigators recently~     found that this transfer to functioning is more meaningful and durable when using additional~     techniques that teach people skills such as being aware of your own thinking and to use~     multiple, flexible problem solving strategies.~      The goal of this project is to address these limitations by testing a new development in the~     treatment: delivering cognitive remediation to participants in their homes, with cognitive~     exercises and therapist support provided online. The techniques are the same as successful~     in-session cognitive remediation, but those with psychosis can engage in the intervention at~     home and therapists will be able to service more individuals with online discussion forums~     and video demonstrations. The more people engage in cognitive remediation, the better the~     outcomes. This is particularly true for receiving a consistent dose of exercise, rather than~     in longer, once per week sessions typical of traditional psychotherapies. The online~     component of this program provides patients with the ability to engage in a higher and more~     consistent rate of exercises and skill development, and we will explore whether the amount~     and continuity of engagement is associated with larger and broader improvements.~   "
110499|NCT02121093|"~     The vibration stimulation is regarded as a new method of training and therapy to change~     afferent parts and cortical projections, which are important for motor control. This study~     aims to check effects of different frequency parameters for electrical cortical potentials~     and electrical muscular potentials in healthy young adults. 80 volunteers will participate in~     the study, and they will be randomly subdivided in four groups for trials. The methodology~     consists of electroencephalographic and electromyographic assessment before and after~     15-minute vibration application with a digital vibratory pad.~   "
110500|NCT02121080|"~     This is a phase 1, randomized, double-blind, placebo-controlled study evaluating the safety,~     tolerability, pharmacokinetic (PK) profile, and immunogenicity of REGN2222 ascending in~     cohorts of healthy adult volunteers.~   "
110501|NCT02121067|"~     This is a study of 50 postpartum women interested in having the Mirena® LNG-IUS placed for~     contraception. The Mirena® is an FDA approved intrauterine contraceptive device that provides~     contraception for 5 years with excellent effectiveness. Women enrolled in this study will~     only have the Mirena® placed at two-weeks postpartum (day 14-20 postpartum). The participants~     will be followed at 6-weeks and 6-months postpartum for study visits to evaluate for~     satisfaction, symptoms, expulsion, and perforation. The study will be completed at six-months~     postpartum, and participants will be able to keep their LNG-IUS following study completion.~   "
110502|NCT02121054|"~     The purpose of this study is to evaluate the prognosis of patients with resistance to~     antiplatelet agent and develop tailored treatment model for patients with coronary artery~     disease.~   "
110503|NCT02121041|"~     The purpose of this study is to compare the effectiveness of ambulatory blood pressure~     monitoring to usual care (blood pressure measurement in the office) in diagnosing and~     managing hypertension.~   "
110504|NCT02121028|"~     The objective of this study is to determine the mechanisms of stroke in patients with~     Intracranial Atherosclerotic Disease (IAD) by specifically evaluating limitations of~     antegrade flow through the stenotic artery, distal tissue perfusion to the affected~     territory, and artery-to-artery embolism. The hypothesis is that non-invasive imaging~     biomarkers that stratify stroke risk and distinguish mechanisms of IAD. This prospective~     multicenter study will enroll 175 patients with recently symptomatic high-grade IAD. Patients~     will be studied within 21 days of the index event (allowing appropriate time to arrange for~     diverse imaging modalities), with the following advanced neuroimaging techniques to elucidate~     mechanisms of recurrent ischemia:~        -  Quantitative magnetic resonance imaging (QMRA) to assess volumetric flow rate through~          the stenotic artery.~        -  Magnetic resonance perfusion weighted imaging (PWI-MRI) to determine distal tissue~          perfusion.~        -  Vasomotor reactivity by Transcranial Doppler using the breath-holding technique~          (BHI-TCD) to assess compensatory flow characteristics to the territory distal to the~          affected artery;~        -  Transcranial Doppler with embolic signal monitoring to evaluate artery-to-artery~          embolism that reflects plaque instability.~      Patients will receive standardized medical management and its effectiveness on blood~     pressure, lipid, and glycemic control will be monitored.~      The primary outcome is recurrent stroke in the territory of the stenotic artery during a~     1-year follow-up period; secondary outcomes are: a) new asymptomatic ischemic lesions on MRI~     in the distribution of the stenotic artery at 6-8 weeks, and b) transient ischemic attack~     (TIA) in the distribution of the stenotic artery during a 1-year follow-up period.~      Patients will be recruited at various sites that will be trained and certified on the imaging~     techniques employed. Raw imaging data will be interpreted centrally.~   "
110505|NCT02121015|"~     The overarching aim of this project is to develop and pilot an innovative online intervention~     (Share) that integrates an Individual Internet Intervention (III) and an Internet Support~     Group (ISG) in preventing Postpartum Major Depression (PPMD). To establish that supportive~     accountability is a critical component of the intervention, Share will be compared to an III~     alone, and an ISG without the III components.~   "
110506|NCT02121002|"~     To establish the therapeutic equivalence and safety of a generic Diclofenac Sodium Topical~     Gel, 1% with Voltaren® Gel 1% in subjects with osteoarthritis of the knee.~   "
110507|NCT02120989|"~     We will undertake initial development of a new behavioral sleep intervention (i.e.,~     partner-assisted Cognitive Behavioral Therapy for Insomnia; CBT-I), based closely on the gold~     standard treatment, CBT-I. We will examine if the new treatment has a positive impact on~     subjective and objective sleep and quality of life in a clinic-based sample. Secondary aims~     will examine treatment adherence and maintenance of therapeutic gains as well as relationship~     satisfaction and broader psychiatric functioning.~   "
110511|NCT02120937|"~     Mindfulness group therapy can help children with mood irregularities and family history of~     bipolar disorder.~   "
110513|NCT02120911|"~     Despite neoadjuvant chemoradiation regimens esophageal cancer remains a disease with poor~     outcome. The clinical benefit of HER2 targeting with trastuzumab has been shown in the~     setting of advanced disease and disease and safety of combining trastuzumab with~     chemoradiation in the curative setting has been established. In breast cancer, the added~     value of pertuzumab to standard treatment with trastuzumab has been shown both in the~     neoadjuvant and the metastastic setting. Taken together, there is a sound rationale to~     explore the combination of radiotherapy plus chemotherapy with trastuzumab and pertuzumab in~     HER2+resectable esophageal cancer. However, since the number of HER2+ patients in this~     setting is limited, and no data are available on the safety of this combination prior to~     major surgery, we propose to first conduct a feasibility study with this treatment stratgy.~     When the results of this study show that this treatment strategy is feasible, we will~     subsequently design a prospective study with efficacy as primary endpoint.~   "
110514|NCT02120898|"~     The purpose of this study it so compare the safety and efficacy profiles of a generic~     imiquimod 2.5% cream to the reference listed Zyclara® (imiquimod) cream in the treatment of~     actinic keratosis.~   "
110515|NCT02120885|"~     Gastric cancer is a major health issue and one of the most common malignance in Korea. With~     the popularization of cancer screenings and increasing the average lifespan, the number of~     gastric cancer patients is increased. In the past, most of the research were concerned with~     survival and recovery after cancer surgery. However, as the medical technology had been~     developed and recovery rate and survival rate of cancer patients had risen, the patients~     wanted to return to a daily life and desire for participation for leisure. In other words,~     the patients who underwent surgery wants to maintain a high quality of life(QOL) level as~     like prior to cancer surgery.~   "
110516|NCT02120872|"~     The purpose of the present study was to investigate the efficacy of autologous Platelet rich~     fibrin (PRF) or PRF and Simvastatin (SMV) with open flap debridement (OFD) in the treatment~     of three wall intrabony defects in comparison to OFD alone.~   "
110517|NCT02120859|"~     We aimed to evaluate feasibility and the 6-month angiographic and OCT results of FFR - guided~     use of paclitaxel-eluting balloons (Sequent Please™, B Braun) with provisional bare metal~     stenting for elective PCI of de novo coronary lesions.~   "
110518|NCT02120846|"~     Forty patients will be assigned to either a training group (12 wk unilateral knee extension~     flywheel resistance exercise; 4 sets of 7 reps 2 days/week) or a control group. Patients will~     maintain daily routines and any prescribed rehabilitation program. Established methods to~     assess muscle and cognitive function will be employed before and after the intervention.~      This project will disclose whether an exercise paradigm, known to improve muscle function and~     increase muscle volume in healthy populations, will induce similar adaptations in chronic~     stroke patients. More importantly, this study will elucidate if any impairment in cognitive~     function caused by stroke, can be reversed with this particular resistance exercise regimen.~      The information gained from this project will have significant implications and aid in~     advancing rehabilitation programs and exercise prescriptions for men and women suffering from~     stroke. The overall objective of this research is to promote independence and hence quality~     of life in these patients.~   "
110519|NCT02120833|"~     This study is for infants with mild to moderate dry and itchy skin. This study will involve~     going to the doctor for 6 visits over 2 weeks. All participants' skin will be examined by a~     dermatologist to determine if they have atopic dermatitis and have an active mild to moderate~     eczema wound. Participant's parents/guardians will be asked a few questions to determine if~     their child qualifies for the study.~      Then all participants' caregivers will complete a questionnaire at the beginning of the~     study. The child's skin will be examined to rate the level of their eczema and a trained~     examiner will grade the looks and symptoms of their eczema. All parents or guardians will be~     instructed how to apply the test product and how to record usage on a diary card and then~     apply the test product. The test product will be applied at least 2 times per day or more as~     needed on all body areas, including the face affected throughout the study.~      One digital picture will be taken of one eczema wound. Another digital picture will be taken~     of the area around this wound. These pictures will be taken on Day 0 (Baseline), Day 3, and~     Day 14.~      Once product is applied the skin will be examined for any adverse events and all~     participants' caregivers will complete a questionnaire on study day 1, 3, 7 and 14.~   "
110520|NCT02120820|"~     The aim of this study is to evaluate the effectiveness of multisensory environment (MSE)~     and/or massage therapy (MT) in residents with severe and profound intellectual disabilities~     (ID) who received massage therapy in MSE, activities in MSE alone, massage therapy in usual~     care environment, or usual care with attention.~      Since there has not yet been any conclusive evidence to show the clinical efficacy of MT and~     MSE on relaxation and reducing challenging behaviours, the following null hypotheses are~     suggested:~        1. There will not be any differences on reducing heart and respiration rates between~          MT-MSE, MT, MSE, and usual care only over the 10-week intervention period and a 2-week~          follow-up.~        2. There will not be any differences on adaptive behaviours and levels of alertness between~          MT-MSE, MT, MSE, and control group over the 10-week intervention period and a 2-week~          follow-up.~        3. There will not be any differences on frequency and severity of challenging behaviours~          between MT-MSE, MT, MSE, and control group over the 10-week intervention period and a~          2-week follow-up.~   "
110521|NCT02120807|"~     The purpose of this study is to test the safety of certolizumab when it is given with the~     chemotherapy drugs cisplatin and pemetrexed. Cisplatin and pemetrexed are two chemotherapy~     drugs used in the treatment of lung cancer. The investigators want to find out what effects,~     good and/or bad, certolizumab has on the patient and lung cancer.~   "
110522|NCT02120794|"~     The study objective is to demonstrate that home use of Threshold Suspend (TS) is not~     associated with glycemic deterioration in pediatric patients with type 1 diabetes, as~     measured by change in A1C.~   "
110523|NCT02120781|"~     The objectives of this study are to assess the safety of azficel-T treatment for dysphonia~     related to vocal fold function and to evaluate the efficacy of azficel-T for the treatment of~     dysphonia related to vocal fold function.~   "
110816|NCT02116959|"~     The purpose of this study is to test the safety of the treatment combination of alternating~     standard chemotherapy and another (melphalan) chemotherapy at different interval schedules.~     Researchers want to find out what effects, good and/or bad, the treatment combination has on~     the patients and their retinoblastoma.~   "
110524|NCT02120768|"~     The randomized, controlled trial is aiming at comparing local control rate between two~     surgical resections, barrier resection and local wide resection with 1cm or equivalent normal~     tissues. This is based on the fact that the goal of local surgical treatment is to remove the~     tumor with negative margin and best functional outcome, but there is a lack of standard~     principle of surgery. Some surgical oncologists recommended enlarging surgical field in which~     case the associated muscle was removed from origin to insertion, the previous surgical scar~     and radiation field were also grossly remove, though there would be extra trauma and~     unacceptable function impairment, they believe that patients would benefit from big~     operations. Most other surgeons would perform a sarcoma resection through normal tissues,~     and reported a fair local control as long as a negative margin was obtained. As reported by~     various authors, recurrent STSs are associated with higher risk to develop further recurrence~     as compared to primary STSs, thus, efforts should focus on this category of STSs to improve~     outcome.~   "
110525|NCT02120755|"~     This research project is testing a product called AmnioClear™ which is an amniotic membrane~     graft processed for Liventa Bioscience formerly AFCell Medical. AmnioClear™ allograft human~     amniotic membrane is regulated solely under section 361 of the Public Health Service Act.~      The purpose of the study is to see if this treatment works to accelerate the healing time of~     chronic wounds.~   "
110526|NCT02120742|"~     This study seeks to evaluate the impact of a text-message (SMS) program delivered to~     motorcycle drivers in Dar es Salaam, Tanzania. The SMS program, delivered by nonprofit Amend,~     sends daily reminders to motorcycle drivers to remind them to wear their helmets. In this~     study, the investigators will conduct a randomized controlled trial to see if this program~     leads to increased helmet use over time. The investigators will recruit between 350-400~     motorcycle drivers to receive the text program. The investigators will obtain each of their~     cell phone numbers, and the participants will be split into three groups. The first group~     will receive reminders framed as social norming (ie Most of your peers wear helmets). The~     second group will receive reminders framed as fear appeals (ie Not wearing your helmet~     increases your chance of dying in an accident). The third group will act as the control and~     receive texts that relate to general road safety, but not helmet use. All groups will receive~     the same general road safety information being delivered to the control arm. The purpose of~     sending different types of reminders is to assess which type of messages are more likely to~     cause a motorcycle driver to regularly wear their helmet. The investigators will survey the~     participants at the initiation of the study and after weeks 3 and 6 during the study, asking~     about their helmet use. This will be a short survey, and any personal information gathered~     during the study (ie, phone numbers), will be securely stored so as to protect their privacy.~   "
110527|NCT02120729|"~     This Randomized Clinical Trial (RCT) compares outcomes in 1500 patients with major depressive~     disorder (MDD) treated according to the patient's CYP2D6 genotype status (N=1000) versus~     empiric standard-of-care psychotropic therapy (N=500). The hypothesis is that provision of~     medication based on the functional status of the patient's CYP2D6 enzyme inferred from~     genotype results within 48 hours of admission to treating clinicians will, through refined~     selection of psychotropic medication during hospitalization, decrease length of psychiatric~     hospitalization stay and decrease the rate of 30 day re-admission.~      The trial setting is the Hartford Hospital Institute of Living (IOL). The IOL operates the~     Clinical Evaluation and Monitoring System (CEMS), an innovative electronic messaging system~     developed by Co-Investigator Dr. J.W. Goethe. The Hartford Hospital Genetics Research Center~     (GRC) performs the genotype testing. CYP2D6 genotype analysis detects all known polymorphisms~     that result in an enzyme with sub-normal or supra-normal function. In this study, CEMS~     transmits clinically actionable guidance based on the patient's genotype to the clinician,~     advancing the medication alerts in real time.~      The RCT will test the effects of timely incorporation of medication recommendations based on~     CYP2D6 genotype into CEMS. The RCT assigns 500 patients to standard therapy (Group S) for~     whom CYP2D6 genetic information is determined but not transmitted to the treating clinician,~     allowing psychotropic therapy to be empirically determined, and 1000 to genetically guided~     therapy (Group G) where genotyping result and treatment recommendations are furnished via~     CEMS to the clinician within 24 hours of DNA sampling and 48 hours of admission. For patients~     in Group G who are poor or rapid metabolizers, medications primarily metabolized by the~     CYP2D6 enzyme are proscribed.~      The primary outcome is hospital length of stay and the secondary outcome, the frequency of 30~     day hospital readmission. Additional genetic stratification of both Group S and Group G will~     allow investigation of specific psychotropic usage.~      The expected benefits are 1) quantitative understanding of the effect of providing CYP2D6~     pharmacogenetic information on length of hospitalization, 30 day readmission rate, and~     associated costs; and 2) objective benchmarking for the comparative effectiveness of CYP2D6~     genotyping for guiding psychotropic therapy.~   "
110528|NCT02120716|"~     The objective of this study is to develop and determine feasibility of a computer-delivered~     intervention (Health Check-up for Expectant Moms) approach to target women at risk for~     HIV/STIs and alcohol/drug use during pregnancy through two phases of testing:~      The development aims of this study are to:~        1. Develop intervention content.~        2. Perform a small open trial (n = 10) of the computer based intervention (Health Check-up~          for Expectant Moms) to assess feasibility of recruitment of target population and~          acceptability of the intervention and study procedures via participant report of ease of~          use, helpfulness, and overall satisfaction.~      The pilot study aims of this study are to:~        1. Conduct a randomized controlled pilot study in a sample of 50 high risk (at risk for~          HIV/STIs and alcohol/drug use) pregnant women.~        2. Determine:~             1. feasibility of the computer based intervention~             2. acceptability via participant report of ease of use, helpfulness, and overall~               satisfaction~             3. evidence for the hypothesized effects on outcomes: the proposed intervention, in~               comparison to a time-and-attention-matched control group, will produce reductions~               in HIV/STIs risk behavior during the follow-up assessment at 4 months.~        3. Determine if the intervention condition, relative to control, will produce reductions in~          alcohol/drug use (frequency, quantity, and heavy drinking/use frequency).~        4. Determine effects on process variables: if participants assigned to the intervention~          condition, relative to control, will demonstrate greater increases in knowledge,~          readiness to change and risk perceptions.~   "
110529|NCT02120703|"~     Pregabalin is claimed to have superior analgesic effect at lower doses and better~     pharmacological profile as compared to gabapentin esp. in perioperative pain control after~     major surgeries like intervertebral disc surgery.~      The investigators found that pregabalin is equivalent to gabapentin for relief of~     post-operative pain at a lower dose in patients undergoing intervertebral disc surgery.~   "
110530|NCT02120690|"~     To the investigators knowledge there are no studies of Trigeminal Nerve Stimulation (TNS) for~     fibromyalgia. TNS may modify overlapping mood and fibromyalgia pain regulation circuitry. The~     investigators hypothesized that patients with fibromyalgia might experience a clinically~     significant reduction in daily pain if investigators were to administer TNS in a manner~     similar to experimental antidepressant protocols.~   "
110531|NCT02120677|"~     This research is being done to study the molecular effects of topically applied itraconazole~     ointment on the growth of basal cell carcinomas.~   "
110533|NCT02120651|"~     The diagnosis of tympanic perforation reaches a high number of records in otorhinolaryngology~     services worldwide. Most of the tympanoplasties are performed in patients whose cause of~     perforation and hearing loss was chronic otitis media; this entity affects the population~     between 0.5 to 30% , the statistics mention more than 20 million people with this disease in~     the world. Since the introduction of tympanoplasty in the second half of the nineteenth~     century there have been numerous publications nationally and internationally about various~     experiences and new techniques. Including the use of fibrin monomer . This procedure is~     usually performed with the use of hemostatic sponge and recently with fibrin monomer, both~     materials are part of the basic input and surgical hemostatic agents. In this hospital are~     performed on average 110 tympanoplasty per year which has a percentage of non- integrity of~     the graft in the case of microscopic tympanoplasties using hemostatic sponge of 16% which is~     similar to the index of lack of integrity of the graft in microscopic tympanoplasties~     reported worldwide (18%), with the recent addition to the service of fibrin monomer, was~     necessary to evaluate if this material contributes to the integrity of the graft in~     microscopic tympanoplasty, as it has been reported in previous studies, so if there is found~     more integrity with this material, it can be recommended for routine use, improving the final~     prognosis of the patients.~   "
110534|NCT02120638|"~     Multidrug resistant tuberculosis (MDR-TB) is difficult to treat and raises a great challenge~     to TB control program. That pyrazinamide can shorten the course of treatment and facilitate~     bacilli clearance has been proved recently. In 2011, WHO recommended to use pyrazinamide~     throughout the course of treatment for MDR-TB. However, pyrazinamide susceptibility testing~     has not been widely used in clinic. And the conventional testing is time-consuming and~     unreliable. In contrast, the detection of pncA and rpsA mutations with molecular methods can~     provide rapid results of pyrazinamide susceptibility. The purpose of this study is to~     evaluate the efficacy of the introduce the molecular testing of pyrazinamide susceptibility~     in optimizing the MDR-TB treatment regimen.~   "
110535|NCT02120625|"~     The purpose of this study is to document the effectiveness of the Nimbus Multi-tined~     Expandable Electrode (MEE) Probe in carrying out the heating and ablation (cutting) of the~     small medial branch nerves that carry pain information from the facet joints. Subjects will~     be selected, by way of clinical evaluation and response to medial branch blocks, to undergo~     this procedure of radiofrequency ablation/neurotomies of the medial branches to the specific~     painful facet joints of the low back in order to relieve pain. This will be carried out with~     an FDA-approved device using a standard technique that has been accepted throughout the~     world. The difference in this study is that we will make use of MRIs to image the lesion that~     is produced and a special EMG study to look at the muscles in the back to document the~     effectiveness of the device in creating the intended lesion. No other study of this kind has~     been produced to look at this or any other radiofrequency device in the treatment of low back~     pain.~   "
110536|NCT02120612|"~     The purpose of this study is to determine the effect that an educational intervention has on~     patient knowledge of the signs of opioid overdose and appropriate use of naloxone in a~     suburban outpatient treatment program.~   "
110537|NCT02120599|"~     Malnutrition during pregnancy is more common in poor women in the developing world due to~     inadequate dietary intake combined with increased nutrient requirements; pregnancy risk is~     more consequential than among other demographic groups with increased risk of maternal and~     infant mortality and the lifelong effects of fetal malnutrition. The benefits of treating~     moderate malnutrition during pregnancy remain largely undocumented. This study tests the~     hypothesis that providing either a fortified flour or fortified paste-based supplementary~     food designed to replete the nutrient deficits during pregnancy will result in improved~     maternal nutritional recovery rates and higher infant birth weights and lengths. This study~     is a randomized, controlled clinical trial of 3 supplementary foods in 1800 moderately~     malnourished Malawian women who are pregnant. Subjects will receive one of 3 food rations: 1)~     a ready-to-use supplementary food formulated to deliver about 200% of the recommended daily~     allowance (RDA) of most micronutrients in pregnancy (RUSF-P), 2) corn soy blend with a~     multiple micronutrient tablet chosen to deliver about 200% of the RDA of most micronutrients~     (CSB-P) or 3), the standard of care which is a corn soy blend with supplementary iron and~     folic acid (CSB), delivering between 0-350% of the RDA. Subjects will receive the~     supplementary food until they recover from MAM. The outcome of the pregnancy and maternal~     nutritional status will be followed until 3 months after delivery.~   "
110538|NCT02120586|"~     This study evaluates two strength training protocols (one in peripheral muscles and one in~     inspiratory muscles) in the improvement of skeletal muscle mass and function in~     institutionalized elderly with sarcopenia. Participants will be assigned randomly in a~     control or one of both experimental groups.~   "
110539|NCT02120573|"~     This prospective study evaluate teaching efficacy of CPR training using different methods in~     general population, medical students and non medical students with the 12 months evaluation~     of its recall~   "
110554|NCT02120378|"~     Due to the discrepancy between the Egyptian and the conventional definition of miscarriage or~     live birth, there seemed to be a need for a study that ends up with reaching a definition for~     the mentioned terms. live birth is known to be for fetus born after 20 weeks or of weight~     more than 500 grams, while in Egypt, this is not applicable. basically the neonate has a~     chance of survival if the weight is more than 1000 grams or of gestational age more than 26~     weeks.~   "
110555|NCT02120365|"~     The purpose of this study is to determine whether perampanel alters the response to alcohol~     for heavy drinkers. It is hypothesized that perampanel will reduce the rewarding and~     reinforcing properties of alcohol in the laboratory setting.~   "
110639|NCT02119273|"~     Oral corticosteroids are commonly utilized for the management of chronic rhinosinusitis with~     and without nasal polyps (CRSwNP and CRSsNP, respectively). Although strong evidence supports~     the benefit of routine and perioperative oral corticosteroids for CRSwNP, there is limited~     evidence to support their utility for CRSsNP. The investigators intend to perform a~     randomized, double blind, placebo controlled clinical trial to investigate the impact of~     steroids used within 2 weeks prior to surgery for CRSsNP. Patients with CRSsNP that present~     to the investigators office will be included if they have failed maximal medical management~     and have elected to undergo endoscopic sinus surgery (ESS) after July 1, 2014. The~     investigators hypothesis is that oral corticosteroids given 2 weeks prior to surgery will~     improve subjective and objective outcome measures.~   "
110540|NCT02120560|"~     Atrial fibrillation (AF) is the most common cardiac arrhythmia in the United States, and~     treatment by AF ablation is quickly becoming the favored definitive therapy. Nonetheless, AF~     ablation comes with some risk, including bleeds related to vascular access and myocardial~     damage, as well as the rare incidence of clinical stroke from blood clots that travel from~     the heart to the brain, termed cerebrothromboemboli. In fact, cerebrothromboemboli without~     any symptoms have been detected by special imaging procedures called brain magnetic resonance~     imaging (MRI) in as many as 22% of cases.(1-6) There remains clinical equipoise amongst~     experts regarding balancing the risks and benefits of continued versus interrupted blood~     thinning, or anticoagulation during AF ablation as they pertain to risk of bleed and~     cerebrothromboemboli prevention, respectively, and the potentially more subtle sequelae of~     these apparently silent cerebrothromboemboli remain unknown. In fact, both interruption and~     continuation of anticoagulation during AF ablation are the standard of care. The~     investigators will perform the first randomized trial of uninterrupted versus interrupted~     anticoagulation in patients undergoing AF ablation to determine if it mitigates neurologic~     injury. The objective of this research is to investigate the effect of continued~     anticoagulation for AF ablation on cerebrothromboemboli, and the neurocognitive sequelae of~     embolic lesions, which to this point are considered subclinical. The investigators~     hypothesize that continued anticoagulation will both reduce cerebrothromboemboli and mitigate~     any potential decline in neurocognitive function post-procedurally. The investigators also~     hypothesize that the incidence of cerebrothromboemboli (CTE) by MRI will mediate that~     difference.~   "
110541|NCT02120547|"~     To determine whether CVC exposures are altered in subjects with impaired hepatic function,~     compared to subjects with normal hepatic function. The results will help guide the clinical~     use of CVC in patients with hepatic impairment, determine the extent of PK changes, if any,~     and identify the potential need for dose adjustments of CVC in this population.~   "
110542|NCT02120534|"~     The present study will be conducted to determine the dynamic changes of serum soluble CD14~     and the corresponding changes of serum CD88 and their correlation in critically ill sepsis~     and SIRS patients.~   "
110543|NCT02120521|"~     A total of 120 patients will be included in the study. Sixty patients are critically ill with~     evidence of sepsis during ICU stay (sepsis group) and sixty patients are critically ill~     without evidence of infectious organism (SIRS group). At admission, Patients data include~     clinical status; SOFA score; central venous pressure; laboratory analysis and arterial blood~     gas analysis are measured. Routine cultures will be obtained. The attending physician will~     evaluate the patients for sepsis, severe sepsis, or septic shock as long as their stay in~     ICU. A serum level of sTREM-1 and MNDA will be monitored.~   "
110544|NCT02120508|"~     The substantial efficacy and the possible mechanism of repetitive transcranial magnetic~     stimulation (rTMS) improving language recovery remained unclear. It is hypothesized that the~     rTMS was associated with increased synaptic connection and neural regeneration which can be~     evaluated via functional neuroimage and neurofiber imaging analysis. The effect of rTMS~     intervention was monitored by clinical testing and neuroimaging study.~   "
110545|NCT02120495|"~     This study will apply the digital techniques to do the condylectomy through an intraoral~     approach without needing to do the intraoral vertical ramus osteotomy (IVRO). This new~     surgical technique will greatly maintain the TMJ anatomy structure, reduce the risk and~     increase the precision of the operation procedure.~   "
110546|NCT02120482|"~     Recipient desensitization is a prerequisite for successful ABO-incompatible kidney~     transplantation (ABOi-KTX). Published desensitization protocols commonly include the use of~     plasmapheresis or selective (i.e. antigen-specific) immunoadsorption (IA), together with~     distinct immunomodulatory measures (e.g. CD20 antibody rituximab). Selective IA represents an~     efficient but cost-intensive therapy. An alternative could be the use of semi-selective~     (non-antigen-specific) IA. Even though highly efficient in depleting ABO-specific IgG,~     semi-selective IA may only marginally affect levels of ABO-specific IgM, which might - due to~     the strong complement activating potential of this Ig class - exhibit a potential risk for~     (hyper)acute antibody-mediated rejection (Wahrmann et al. 2012, Nephrol Dial Transplant). In~     a randomized crossover trial (Eskandary et al. 2014, Nephrol Dial Transplant;~     www.clinicaltrials.gov, NCT01698736) we have recently shown that the combination of~     semi-selective IA together with membrane filtration, a technique primarily used in the field~     of LDL apheresis, can yield excellent elimination of both IgM and IgG reactivities, as well~     as essential macromolecules such as the classical complement key component C1q. In this~     two-center phase 2 pilot study (N=10) we plan to evaluate the safety and efficacy of this~     alternative desensitization strategy in ABOi-KTX.~   "
110547|NCT02120469|"~     This phase I/IB trial studies the side effects and best dose of eribulin mesylate and~     everolimus in treating patients with breast cancer that does not have estrogen receptors,~     progesterone receptors, or large amounts of human epidermal growth factor receptor 2 protein~     (triple-negative) and has spread to other places in the body (metastatic). Eribulin mesylate~     and everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth.~   "
110548|NCT02120456|"~     Part 1: To identify Maximum Tolerated Dose (MTD) levels of LEO 43204 after once daily~     treatment for two consecutive days~      Part 2: To evaluate the efficacy of LEO 43204 in two doses after once daily treatment for two~     consecutive days compared to vehicle~   "
110549|NCT02120443|"~     A single arm study of 40 adult volunteers to assess the safety and efficacy of the ivWatch~     Model 400 when observing non-infiltrated (normal) tissues at common peripheral IV therapy~     sites.~   "
110550|NCT02120430|"~     There is an increasing need for parenting programs aimed at promoting parent-child~     interaction. A variety of interventions have been proposed. The use of audiovisual materials~     for parents has been shown to be effective but limited information is available on the~     optimal timing for its use, particularly for new parents during the first year of life of~     their children.~      Based on the hypothesis that the effectiveness of information provided to first-time parents~     in modifying their knowledge, attitudes and intentions regarding rearing practices may depend~     on when the information is delivered, we designed an open randomized controlled trial to~     compare the effectiveness of administering a video at two different times, i.e. at one and~     seven months of age of the child.~      The video addressed four specific activities related to early child development: reading~     aloud to the baby, early exposure to music, promotion of early socialization for parents and~     for children.~   "
110556|NCT02120352|"~     This study is a Phase IIb, randomized, multicentre, parallel group, open-label, study having~     an overall objective to evaluate the antiviral activity, tolerability, and safety of two~     intramuscular (IM) dosing regimens of GSK744 LA plus TMC278 LA, relative to GSK744 30~     milligram (mg) plus Abacavir/Lamivudine (ABC/3TC) given orally once daily (QD), in HIV-1~     infected antiretroviral-naïve subjects. GSK744 is the oral formulation of GSK1265744~     (cabotegravir), GSK744 LA is the long acting injectable formulation of GSK1265744 and TMC278~     LA is the long acting injectable formulation of TMC278.~      The study will consist of three parts: an Induction Period, Maintenance Period and Extension~     Period. There is also a Long-Term Follow Up Period for subjects who withdraw from the study~     and have received at least one dose of GSK744 LA and / or TMC278 LA. In the Induction Period,~     eligible subjects will receive a combination of an oral regimen of 30 mg of GSK744 and~     600/300 mg of ABC/3TC, once daily for 20 weeks. In the Maintenance Period, eligible subjects~     will be randomized 2:2:1 at Day 1 to receive an IM regimen of GSK744 LA 400 mg + TMC278 LA~     600 mg every 4 weeks for 96 weeks (Q4W), an IM regimen of GSK744 LA 600 mg + TMC278 LA 900 mg~     every 8 weeks for 96 weeks (Q8W), or to continue on the oral Induction Period regimen of~     GSK744 30 mg + ABC/3TC once daily for 96 weeks (or 104 weeks if continuing on to the~     Extension Period). The Extension Period will allow for a collection of longer term efficacy~     and safety and tolerability data from subjects receiving GSK744 LA and TMC278 LA.~      The study will involve sufficient subjects at screening in order to ensure a total of~     approximately 265 subjects at the beginning of the Induction Period and approximately 225~     subjects randomized into the Maintenance Period.~   "
110557|NCT02120339|"~     Estimate the effect of chronic beta-adrenergic receptor blockade with carvedilol on RV~     function in patients with PAH.~      Assess the safety and tolerability of chronic carvedilol therapy in patients with PAH~   "
110558|NCT02120326|"~     The purpose of this study is to determine whether TDCS is an effective prophylactic therapy~     of chronic migraine.~   "
110559|NCT02120313|"~     The purpose of this study is to compare the effectiveness of inpatient and outpatient~     rehabilitation following total knee arthroplasty. No studies exist that have evaluated these~     two rehabilitation programmes in a specific orthopaedic patient population with a focus on~     motor performance. We hypothesized that patients participating in outpatient care tend to be~     physically more active than patients in the rehabilitation clinic, leading to the assumption~     that outpatient rehabilitation has superior functional outcomes compared to the inpatient~     standard-of-care therapy.~   "
110560|NCT02120300|"~     The primary objectives of this study are to evaluate the antiviral efficacy, safety, and~     tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC)~     in participants with genotypes 1 and 4 hepatitis C virus (HCV) infection and sofosbuvir (SOF)~     plus ribavirin (RBV) in participants with genotypes 2 and 3 HCV infection. Participants with~     an inherited bleeding disorder and chronic HCV infection (either monoinfected or HIV-1/HCV~     coinfected) will be enrolled.~   "
110561|NCT02120287|"~     This is a phase II study on the usage of stereotactic Gamma Knife radiosurgery as a boost to~     the tumor bed border zone in conjunction with the usage of bevacizumab.~   "
110562|NCT02120274|"~     The purpose of this study is to evaluate the effectiveness of the supplementation of vitamins~     D and B12 in combination with Pegylated Interferon-Alfa and Ribavirin in the treatment of~     genotype 1 chronic hepatitis C, who do not qualify to receive protease inhibitor in Brazil.~   "
110563|NCT02120261|"~     This study is a prospective, randomized, double-blinded trial involving adult patients~     diagnosed with Myofascial Pain Syndromes (MPS). The purpose of this research study is to~     compare if there is a therapeutic difference between trigger point injections of normal~     saline and conventional drug mix (local anesthesic + steroid) in treating MPS. In particular,~     we will find out about the pain level and duration before and after injection.~   "
110564|NCT02120248|"~     The U.S. Surgeon General has recommended that peer counseling to support breastfeeding become~     a core service of the Supplemental Nutrition Program for Women, Infants and Children (WIC).~     As of 2008, 50 percent of WIC clients received services from local WIC agencies that offered~     peer counseling. Little is known as to the effectiveness of these peer counseling programs.~     Randomized controlled trials of peer counseling interventions among low-income women in the~     U.S. showed increases in breastfeeding initiation and duration, but it is doubtful that the~     level of support provided could be scaled up to service WIC clients nationally. The~     investigators tested whether a telephone peer counseling program among WIC participants could~     increase breastfeeding initiation, duration and exclusivity.~   "
110565|NCT02120235|"~     Although lysosomal storage disorders, such as Fabry disease, Gaucher disease, and Pompe~     disease, represent serious challenges in the healthcare system, no study has yet investigated~     the prevalence of these diseases in the US. Frequently, patients show progressive worsening~     of symptoms for several years before they get diagnosed. Since many of these diseases can be~     managed therapeutically, it is important to identify and treat patients in order to avoid~     organ damage. The investigators aim to undertake a screening study that identifies~     undiagnosed patients with lysosomal storage disorders and determine the prevalence of these~     diseases with special focus on underrepresented minority groups.~   "
110566|NCT02120222|"~     This phase I clinical trial studies the side effects of selinexor in treating patients with~     melanoma that cannot be removed by surgery. Drugs used in chemotherapy, such as selinexor,~     may stop the growth of tumor cells, by stopping them from dividing.~   "
110567|NCT02120209|"~     The primary objective of this study is to elaborate a new simple clinical tool for the risk~     of falls among older inpatients.~   "
110568|NCT02120196|"~     The aim of the study is to compare the effectiveness of rifaximin versus norfloxacin for~     secondary prevention of spontaneous bacterial peritonitis in patients with liver cirrhosis~     and ascites.~   "
110600|NCT02119780|"~     This study is purposed to evaluate the efficacy and safety of YVOIRE® contour compared with~     Restylane SubQ™ injected into the anteromedial malar region.~   "
110652|NCT02119104|"~     The purpose of this study is to investigate post marketing use and safety of Prevnar ( 13v)~     in infants vaccinated for the first time at the age of 2 months, inclusive, to 7 months,~     exclusive.~   "
113560|NCT02081014|"~     The purpose of the study is to demonstrate that mini-doses of stable liquid glucagon (G-Pen~     Mini) produced by Xeris Pharmaceuticals are safe and effective as a treatment for mild to~     moderate hypoglycemia, a complication of diabetes.~   "
110569|NCT02120183|"~     This is a study to determine the effectiveness of a Group Therapy that provides~     psycho-education and support for caregivers of cancer patients. Caregivers must be between 21~     and 64 years of age and be willing to attend a one-hour a week program for four weeks. The~     sessions will be in English, and a set of questionnaires (demographic data, some information~     about your family member with cancer, and scales: Caregiver Quality of Life-Cancer Scale~     (CQOLC), Perceived Stress Scale and the Hospital Anxiety Depression Scale (HADS)) will be~     completed at the start, at 4 weeks, at 8 weeks and at 12 weeks. Some participants placed on a~     wait-list to start the Group Therapy 4 weeks later will also complete the set of~     questionnaires at this point. A Feedback and Satisfaction Questionnaire will be completed at~     the end of the 4 week program. In addition, at the end of the 4 week program, some~     participants will go through a 15-minute interview.~   "
110570|NCT02120170|"~     There have been very limited evidence about the bleeding complication during colon~     polypectomy for the patients taking warfarin.~      This study is aimed to analyse the effect of prophylactic hemo-clipping during colon~     polypectomy for the patients with warfarin consumption.~      The enrolled subjects are the patients who take warfarin for high thromboembolism risk and~     should take heparin bridging therapy during colon polypectomy instead of temporary stopping~     warfarin. The investigators will randomize into two groups; the patient enrolled into group 1~     will be performed hemoclipping for all polypectomy lesion irrespective of the presence of~     immediate bleeding. And the patients enrolled into group 2 will be performed hemoclipping~     only for the lesion of immediate bleeding during colon polypectomy.~      The primary endpoint is to compare the rate of delayed bleeding between two groups.~   "
110571|NCT02120157|"~     We propose a multi-institutional phase II haplo-identical T cell replete BMT study in~     children with high-risk leukemias. The myeloablative conditioning regimen prescribed will be~     TBI-based for lymphoid leukemias and busulfan-based for myeloid leukemias. Our goal is to~     establish an easily exportable, inexpensive platform for haplotransplantation that has a~     safety profile equivalent to matched related and unrelated BMTs. The primary objective will~     be to estimate the incidence of 6-month non-relapse mortality, hypothesizing that NRM is <~     18%.~   "
110572|NCT02120144|"~     The aim of study is to examine the combined effect of observation and imagination of gait on~     stride time variability of stride time among in healthy young and older adults.~   "
110573|NCT02120131|"~     the purpose of this study was to test the effectiveness of the envelope flap compared to~     trapezoidal flap in impacted mandibular third molar extractions.~   "
110574|NCT02120118|"~     The primary goals of hyperthermia combined with chemotherapy/radiotherapy on treatment~     failure solid tumors are tumor response rate, while secondary goals are rates of acute and~     late adverse effects, local control rate, distant metastasis rate, progression-free rate and~     overall survival rate.~   "
110575|NCT02120105|"~     The purpose of this study is to determine whether urinary cystine capacity, an assay used to~     measure the amount of cystine in the urine, can be used to predict stone recurrence in~     patients with cystinuria.~   "
110576|NCT02120092|"~     Background: Coronary heart disease is the most common cause of death in industrialized~     countries. Revascularisation by percutaneous coronary angioplasty or thrombolysis is the main~     principle for treatment of the acute coronary syndrome. To inhibit platelet activity patients~     are routinely given acetylsalicylic acid (ASA) and clopidogrel, a second-generation~     thienopyridine. Recently, ticagrelor, a novel cyclopentyl-triazolo-pyrimidine with several~     pharmacological advantages, has demonstrated greater efficacy but a higher bleeding risk than~     clopidogrel. Coronary thrombus formation is a complex process and the antithrombotic~     mechanisms of platelet function inhibitors are incompletely understood. Studies in venous~     blood or in vitro do not truly reflect the in vivo circumstances as they often do not take~     into account flow conditions or the interaction between endothelium, blood cells and~     coagulation factors. Results from animal models may not be relevant for the prothrombotic~     mechanisms in humans. We have developed a technique that allows investigating hemostatic~     system activation directly at the site of thrombus formation in vivo in humans.~      Aim: to compare the inhibitory effects of clopidogrel and ticagrelor (with and without~     concomitant ASA) on hemostatic system activation under circumstances close to the in vivo~     situation.~      Design, patients and interventions: prospective, randomized, double-blind, placebo controlled~     parallel-group study with a 2x2 factorial design including 112 healthy volunteers who will be~     randomised to 4 treatment arms: ticagrelor or clopidogrel + placebo, ticagrelor or~     clopidogrel + ASA.~      Outcome variables: Indicators of platelet and coagulation activation [ß-thromboglobulin and~     thromboxane B2 as well as prothrombin fragment F1+2 and D-Dimer, respectively] will be~     measured before and at several time points during a 8 day period in venous blood and in blood~     emerging from a standardized injury of the microvasculature to determine bleeding time (shed~     blood).~      Statistical considerations: Sample size calculation is based on the percent change in the~     main outcome variable β-TG in shed blood from baseline to 2 hours after treatment start.~     Statistical analysis is based on the full analysis set, including all randomized subjects who~     received at least the starting dose of the study medication and for whom blood collections at~     baseline and at 2 hours after treatment start have been performed.~   "
110577|NCT02120079|"~     This research study is looking to see if in vivo confocal microscopy (IVCM) imaging can be~     used to confirm clinical findings (which are noted by the doctor during an eye exam) and~     measure the immune response to the inflammation in the subject's cornea (the front part of~     the eyeball).~      Additionally, this study is trying to determine the effectiveness of two eye-drops, Lotemax~     and artificial tears, in treating the inflammation associated with DED by measuring changes~     in immune cells with IVCM imaging. The subject will be treated with either Lotemax~     (loteprednol) or artificial tears (a lubricating eye drop with no medication). Lotemax is an~     FDA-approved steroid eye-drop that is often used to treat inflammation associated with DED.~     Artificial tears are approved by the FDA for treatment of dryness associated with DED.~      Thus, this study is designed to determine the effects of the administration of a topical~     steroid, Lotemax, over a treatment period of 6 weeks, using novel methods of detecting~     efficacy. In order to achieve the aforementioned goal, subjects will be prospectively~     randomized to one of two treatment arms - Lotemax or artificial tear. Both groups will follow~     the same study schedule.~   "
110578|NCT02120066|"~     Evaluation of surgical outcome of vitrectomy with subretinal injection of recombinant~     tissue-plasminogen activator for submacular hemorrhage associated with retinal arterial~     macroanuerysms.~   "
110626|NCT02119442|"~     A growing body of data, suggests that transcatheter valves are effective when implanted in~     other locations (mitral, aortic, tricuspid) and in high pressure environments. The~     investigators plan to offer transcatheter valve implantation as an alternative to high risk~     surgery in patients who require revision of a stenotic or regurgitant valve in the~     non-pulmonary position (mitral, aortic, tricuspid). This therapy can provide an alternative~     to patients who may be considered high risk and may not be able to survive a surgical~     procedure.The use of the devices on this protocol are for medical treatment and are not part~     of a clinical trial.~   "
110579|NCT02120053|"~     More than 2 million French people suffer from the widespread disability of edentulism, with~     large consequences on function, nutrition, aesthetics and well-being. Complete denture is a~     common therapeutic strategy.~      The immediate complete denture technique consists in placing the denture in the same clinical~     session as last anterior teeth extractions. With this technique, aesthetic and function are~     immediately reintroduced and the patient is never left toothless or without any denture.~      After teeth extractions, alveolar healing process leads to ridge resorption with bone volume~     modifications and reduction in height and width.~      However ridge bone volume is an essential factor in removable denture stability. With~     implantology as an alternative prosthetic strategy, ridge volume is also a most important~     factor to place dental implants in a situation close to previous dental roots position. In~     order to preserve bone volume, a current alternative strategy proposes to place bone~     substitute materials in tooth sockets after extraction. This strategy was never evaluated~     with the immediate complete denture technique.~      Hypothesis: A new strategy associating immediate complete denture and bone substitute~     material is more effective than conventional immediate complete denture in a bone~     preservation perspective.~   "
110580|NCT02120040|"~     Von Hippel-Lindau (VHL) disease is a severe autosomal dominant genetic disorder (with almost~     complete penetrance) that predisposes to many tumors including some associated with a poorer~     outcome. Clear cell renal cell carcinoma (CCRCC) is the leading cause of mortality.~      The diagnosis of VHL disease may be challenging because tumors have an asynchronous and~     multi-organ development and there is often no apparent hereditary context. As it is admitted~     that VHL disease is underdiagnosed, some countries have decided to recall patients presenting~     one of the potentially VHL disease-associated tumors to screen them for VHL mutation.~     Screening is currently recommended in guidelines but many patients may have not been~     previously screened.~      Hemangioblastoma (HB) of the Central nervous system (CNS) is one of the typical VHL tumors~     and up to 20% of patients with HB show VHL mutation. VHL diagnosis in this population enables~     the diagnosis of other tumor types at an early stage of development since HB is~     chronologically the second tumor occurring during the VHL disease history.~      But it raises critical problems and questions: difficult announcement of a potentially severe~     disease and psychosocial dimension related to inheritance of the disease.~   "
110581|NCT02120027|"~     Irritable Bowel Syndrome with diarrhoea (IBS-D) is a functional gastrointestinal disorder~     characterised by chronic or recurrent abdominal pain or discomfort and diarrhoea. This trial~     aims at the evaluation of the efficacy and safety of oral ibodutant 10 mg once daily as~     compared to placebo in women with IBS-D over a 24-week treatment period.~   "
110582|NCT02120014|"~     The primary hypothesis is that patients with HFREF (heart failure with reduced ejection~     fraction) will demonstrate a markedly expanded intravascular volume which will correlate with~     elevated right heart hemodynamics and increased venous capacitance parameters, whereas~     patients with HFPEF(heart failure with preserved ejection fraction) will demonstrate~     euvolemia to mild volume expansion and a lack of correlation with hemodynamic and venous~     compliance parameters.~   "
110583|NCT02120001|"~     The purpose of this study is to test the efficacy of a novel cleaning device in keeping~     silver-coated endotracheal tubes free from bacterial colonization.~   "
110584|NCT02119988|"~     The purpose of this study is to determine whether TIPS combined with variceal embolization~     are effective in the prevention of variceal rebleeding in patients with liver cirrhosis.~   "
110585|NCT02119975|"~     Dysfunctioning executive functioning, including working memory (WM), is related to~     rumination. Findings show that working memory capacity (WMC) can be increased by training.~     The current study explored by means of a double-blind randomized controlled trial whether an~     adaptive WM training could reduce rumination, anxiety and depression in a sample of 98~     depressed and anxious individuals.~   "
110586|NCT02119962|"~     Burnout patients show deficient working memory functioning. Several studies showed a training~     can increase working memory capacity. In the current study we explored whether training~     working memory can reduce burnout and burnout related symptoms and increase working memory~     capacity.~   "
110587|NCT02119949|"~     Background: Substance abusers show impaired working memory (WM) functioning. Promising~     findings show training WM results in an improved working memory capacity (WMC) and a decrease~     of clinical symptoms in a range of disorders, including alcohol addiction.~      Aim: To test the effect of a WM training in addition to treatment as usual (TAU) on substance~     use, craving, WMC, impulsivity, attention bias and psychopathology.~      Design: A randomized double-blind placebo-controlled trial with a parallel group design. The~     WM training adapted to participants' WMC whereas the placebo training consisted of~     non-adaptive easy versions of these tasks.~      Setting: Two departments of an addiction treatment clinic in Rotterdam, the Netherlands.~      Participants: 120 inpatients diagnosed with an alcohol, cannabis or cocaine dependency who~     were in treatment as usual .~      Measurements: Primary outcome measures: Substance use and craving. Secondary outcome~     measures: WMC, impulsivity, attention bias and psychopathology. Participants were assessed~     before and after 24 sessions of WM training as well as two months after the training.~   "
110588|NCT02119936|"~     Purpose: The investigators plan a feasibility study on an easily disseminated biofeedback~     tool to reduce stress among hospitalized and expecting mothers. Converging evident suggests~     that Heart Rate Variability Biofeedback (HRVB) can improve the threshold of stress management~     and improve executive functioning. Additionally HRVB has been shown to significantly reduce~     anxiety features in women suffering from perinatal depression. The investigators hypothesize~     that HRVB will reduce stress levels among expecting mothers hospitalized for pregnancy~     complications, who are at high risk for depression and anxiety.~      Participants: Expecting mothers hospitalized for pregnancy complication, who are at high risk~     for depression and anxiety.~      Procedures: The investigators plain to use a heart rate variability biofeedback tool to~     measure stress reduction in hospitalized expectant mothers. This tool will be coupled with~     validated surveys and scales, high frequency heart rate variability, saliva samples, and~     qualitative interviews to quantify the reduction in stress from the HRVB tool.~   "
110627|NCT02119429|"~     The purpose of this study is to determine whether or not there is an effect of pumpkin seed~     oil supplementation, 2 grams per day, on blood pressure (systolic and diastolic) in~     premenopausal women.~   "
144059|NCT01681719|"~     this study aims evaluate the ergospirometric values after 03 months of training with WBV in~     elderly health people. The hypothesis is increases of ergospirometric values.~   "
110589|NCT02119923|"~     Anxiety and depression are both associated with impairments in executive functions, including~     working memory (WM) which is needed to maintain and manipulate goal-relevant information. Due~     to these WM impairments anxious and depressed individuals have difficulties inhibiting and~     shifting from irrelevant (negative) information and updating goal relevant information. This~     study explored whether training WM decreases these impairments and reduces clinical symptoms~     and rumination. Eighty-four individuals diagnosed with major depression and forty-nine~     individuals with an anxiety diagnosis executed WM or control tasks three times a week, during~     four weeks. Before, after training and at a two months follow-up measurement depression and~     anxiety symptoms, WM capacity and rumination behaviour were assessed. Training WM did only~     result in a reduction of anxiety symptoms in the depression group. These findings are~     inconsistent with promising results of individual studies showing training WM result in an~     enlarged WM capacity and a decrease of psychopathological symptoms. However, our results are~     in line with recent meta-analyses and reviews which show that WM training do not lead to~     generalized effects and therefore, doubt the clinical relevance of WM training programs.~   "
110590|NCT02119910|"~     This investigation proposes to examine the effectiveness of a technology supported treatment~     manual for pediatric feeding disorders. Children with pediatric feeding disorders display~     intense avoidance behaviors (e.g., crying, tantrums, and disruptions) that prevent~     appropriate nutritional intake during meals and lead to a number of negative and potentially~     life threatening medical outcomes, including chronic malnutrition, growth retardation, and~     placement of a feeding tube. To date, behavioral intervention involving extinction-based~     procedures represents the only treatment for pediatric feeding disorders supported by~     research to improve mealtime behaviors. Due to the chronic and extreme nature of food~     refusal, treatment typically requires intensive, daily intervention conducted at highly~     specialized clinics to improve feeding behaviors. The cost and duration of intervention can~     total as much as $60,000 per child requiring up to 6 to 8 weeks, respectively. The potential~     for serious consequences associated with chronic food refusal, combined with the high cost of~     treatment, intensifies the need to identify means to disseminate effective treatment~     approaches to the broader community of healthcare providers.~      The proposed study represents the first attempt to systematically investigate the use of a~     treatment manual to address chronic food aversion through a randomized, waitlist control~     trial in children treated at the Marcus Autism Center's Pediatrics Feeding Disorders Program.~     This study will involve a total of 20 participants randomly assigned to experimental~     conditions: technology supported treatment manual or waitlist control group (10 in each~     group). Children assigned to the waitlist control group will receive the technology supported~     treatment manual after the specified time on the waitlist. All participants will receive the~     same behavioral protocol involving three treatment sessions per day (45 minutes in length),~     for a total of 15 sessions across five consecutive days. Data will be collected on feeding~     behaviors during each treatment session and at follow-up using trained observers to collect~     data on mealtime behaviors, including acceptance, swallowing, disruption, expulsion, and~     grams consumed. This type of data collection and treatment is standard practice in the~     feeding disorders program; however, the use of a touch screen application for data capture~     with integrated manual is novel to this project.~   "
110591|NCT02119897|"~     Oral mucositis (OM) is a painful and potentially debilitating acute toxicity that frequently~     affects children undergoing hematopoietic cell transplantation (HCT). As a result of~     intensive conditioning with chemotherapy with or without total body irradiation, and in the~     case of allogeneic HCT, graft-versus-host disease (GVHD) prophylaxis, patients are at risk~     for developing diffuse ulcerations of the oral and esophageal mucosa that result in pain and~     suffering, increased utilization of opioid analgesics, and the need for intravenous or total~     parenteral nutritional support. Patients universally report OM as being the worst aspect of~     the HCT experience.A novel approach has been the use of larger light-emitting diode arrays to~     treat the at risk tissues from an extraoral approach, enabling exposure of the oral,~     oropharyngeal, and esophageal mucosa while avoiding the need for intraoral manipulation, and~     requiring only minimal patient cooperation. In this research study, the investigators are~     assessing the feasibility of providing extraorally delivered low level light therapy (LLLT)~     for the prevention of OM in children undergoing myeloablative HCT.~   "
110592|NCT02119884|"~     The purpose of the study is to find patients's response to terlipressin and octreotide during~     hepatic venous pressure gradient measurement by observing portal and systemic hemodynamics.~   "
110593|NCT02119871|"~     To compare the effectiveness of unilateral pulmonary collapse (right lung) to bilateral~     pulmonary collapse for cardiac de-airing in open left-sided heart surgery.~   "
110594|NCT02119858|"~     This clinical trial studies diffuse optical imaging with indocyanine green solution in~     imaging pelvic lymph nodes in patients with stage II prostate cancer undergoing surgery.~     Indocyanine green solution is a special dye that can help doctors see the lymph nodes and~     blood vessels during surgery when visualized under diffuse optical imaging. Indocyanine green~     solution may improve the ability to detect lymph nodes and may lead to improved accuracy of~     lymph node removal.~   "
110595|NCT02119845|"~     The primary objective of this clinical study is to evaluate the preliminary safety and~     effectiveness of using the FLEX-1 device for the creation of an arteriovenous fistula (AVF)~     in patients requiring chronic hemodialysis.~   "
110596|NCT02119832|"~     The primary objective of this clinical study is to evaluate the preliminary safety and~     effectiveness of using the FLEX-1 device for the creation of an arteriovenous fistula (AVF)~     including coiling of the brachial vein during the index procedure in patients requiring~     chronic hemodialysis.~   "
110597|NCT02119819|"~     The main purpose of this study is to compare the safety and effectiveness of the study drug~     known as LY2944876 to exenatide extended-release and placebo in participants with type 2~     diabetes mellitus. All drugs will be given by an injection under the skin. Participants~     remain on stable doses of metformin, as prescribed by their personal investigator if they~     were on metformin at study entry. Participants involvement in the study is expected to last~     about 30 weeks.~   "
110598|NCT02119806|"~     In critically ill surgical patients, delirium (confusion and disorientation) is extremely~     common and is associated with longer hospital length of stay, mortality, cost, and long term~     cognitive impairment. The goal of the study is to establish whether benzodiazepines (a~     sedative, anti-anxiety drug) should be used as part of standard of care or be eliminated by~     comparing the chances of delirium in cardiac surgery patients between two groups: a group~     that receives benzodiazepines during surgery versus a group that does not receive~     benzodiazepines during surgery. Benzodiazepines have historically been used in cardiac~     anesthesia to decrease the risk of anesthesia awareness. The current standard of care is to~     keep the patient on inhaled anesthesia throughout the surgery which eliminates the need for~     intraoperative use of benzodiazepines. Benzodiazepines are still used based on practitioner~     preference. Findings of this study will allow all anesthesiologists to make more informed~     decisions about what level of care our patients need.~   "
110599|NCT02119793|"~     This study is purposed to evaluate the long-term efficacy and safety of repeat treatment of~     YVOIRE® contour injected into the anteromedial malar region in subjects who have completed~     the LG-HACL014 study.~   "
110601|NCT02119767|"~     The Liquid Biopsy System (LBS) is a new catheter (thin tube) designed for sampling blood~     directly from coronary arteries. These arteries supply blood to muscles of the heart and can~     become blocked by 'plaques' leading to chest pain (angina) and heart attacks. Recent research~     has shown that development of ' plaques' inside coronary arteries is controlled by chemicals~     (biomarkers) released into the blood from damaged areas of the artery wall. The LBS is~     designed to collect blood samples at the exact site of plaque formation. By testing these~     blood samples for biomarkers of plaque formation, it is hoped that new diagnostic tests and~     treatments for heart disease may be developed. The proposed investigation is use the LBS in~     humans to detect these biomarkers. The safety of the LBS has already been demonstrated in~     both human and animal studies. The study will enroll 70 patients with coronary artery disease~     who are undergoing routine percutaneous coronary intervention (PCI). PCI is a procedure used~     to open up a blocked coronary artery. It uses a catheter on the end of which is a special~     balloon that is inflated inside the blocked artery to open up the vessel and restore blood~     flow. A small metal spring (stent) is usually inserted to keep the blood vessel open. This~     study will test if the LBS device, when used just prior to a PCI procedure, can detect~     biomarkers released by diseased coronary arteries. The study will also determine if the~     presence of these biomarkers is linked to the long term health of the patient. The study will~     take place at Papworth Hospital, over a period of approximately 8 months (including telephone~     based patient followup calls 30 days, 6 months, 1, 2 and 3 years after the procedure to~     determine patient health).~   "
110602|NCT02119754|"~     This is an open label study of subjects who have failed Protocol PGN-1300. Adult subjects~     (greater than 18 years old) who present with a mildly infected diabetic foot ulcer (IDSA~     criteria) having full thickness (i.e., through the dermis but not involving joint capsule,~     tendon, and bone) and have failed PGN-1300. Subjects must also provide informed consent and~     meet all other entry criteria to be enrolled and receive PluroGel PN.~   "
110603|NCT02119741|"~     Objective and background: The aim of this study is to evaluate the clinical outcome of using~     the hyaluronic acid gel in reconstructing inter-dental papillae at the aesthetic zones in a~     follow-up period of six months.~      Materials and Methods: 30 interdental papilla deficiencies which would meet the the inclusion~     criteria will be evaluated. After applying local anesthesia, 0.2 ml hyaluronic acid gel will~     be injected at the affected areas. This procedure will be repeated 3 times for the evaluated~     areas. Photographs will be taken before injection this material, and at 3 and 6 months~     following the intervention.~   "
110604|NCT02119728|"~     This randomized phase II trial studies how well photodynamic therapy with HPPH works in~     treating patients with squamous cell carcinoma of the oral cavity. Photodynamic therapy uses~     HPPH that becomes active when it is exposed to a certain kind of light. When the drug is~     active, cancer cells are killed. This may be effective against squamous cell carcinoma of the~     oral cavity.~   "
110605|NCT02119715|"~     Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor~     to limit the dosage and the continuation of chemotherapy. A newly pegylated rhG-CSF was~     independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b trials have~     shown that pegylated rhG-CSF has decreased renal clearance, increased plasma half-life, and~     prolonged efficacy in compare with rhG-CSF. The purpose of this study is to determine the~     safety and effectiveness of pegylated rhG-CSF in preventing neutropenia following~     chemotherapy in patients with breast cancer.~   "
110606|NCT02119702|"~     This is a prospective cohort study designed to define the impact of HIV infection and~     antiretroviral therapy (ART) on young adults with perinatal HIV infection as they transition~     into adulthood. A group of perinatally HIV-exposed, -uninfected (PHEU) young adults from a~     similar sociodemographic background and age distribution will be enrolled for comparison.~   "
110607|NCT02119689|"~     The purpose of this research study is to study blood stem cells in diabetic patients and~     normal patients. We would like to better understand if these cells, called endothelial~     precursor cells (EPCs), are not working as expected in people with diabetes. We would like to~     see if the function of these cells can predict the development of diabetic retinopathy.~      Diabetic retinopathy is an eye disease associated with diabetes in which the cells of the~     retina are damaged. It can cause blurred vision, vision loss, blindness or possible bleeding~     in the retina. Even with current treatments, the quality of life for people with diabetic~     retinopathy is much reduced.~   "
110608|NCT02119676|"~     The purpose of this study was to determine if ruxolitinib, in combination with regorafenib,~     is safe and effective in the treatment of metastatic colorectal cancer.~   "
110609|NCT02119663|"~     This was to determine the efficacy, based upon overall survival, of ruxolitinib added to~     capecitabine for the treatment of metastatic pancreatic cancer.~   "
110610|NCT02119650|"~     The purpose of this study was to determine if ruxolitinib, in combination with~     Pemetrexed/Cisplatin and Pemetrexed Maintenance, is safe and effective in the treatment of~     nonsquamous non-small cell lung cancer (NSCLC) that is Stage IIIB, Stage IV, or recurrent.~   "
110611|NCT02119637|"~     Background:~      - Different parts of the brain are involved in feeling touch. Researchers want to study~     whether repetitive magnetic stimulation (rTMS) to the sensory cortex affects how sensation~     feels. rTMS is a repeated magnetic pulse that interferes with brain activity. It affects a~     small part of the brain beneath the scalp. Researchers want to find out the role of sensory~     cortex in sensing different types of touch.~      Objectives:~      - To find out the role of sensory cortex, a brain area, in sensing different types of touch.~      Eligibility:~      - Healthy adults ages 18 45.~      Design:~        -  Participants will be pre-screened with a telephone interview. Then they will be screened~          with physical and psychological exams and a urine test.~        -  In Session 1, participants will have an MRI brain scan and fill out questionnaires.~        -  For MRI, a magnetic field and radio waves take pictures of the brain. Participants will~          lie on a table that slides in and out of a metal cylinder. A coil will be placed over~          their head. They will perform a task during the scan. The scanner makes loud knocking~          noises. Participants will get earplugs. They will be in the scanner for up to 60~          minutes.~        -  In Sessions 2 and 3, participants will take Breathalyzer and urine tests. Their~          perception of touch will be measured. Then rTMS will be used to stimulate their sensory~          cortex and scalp for about 20 minutes. Their perception of touch will be measured again.~        -  For rTMS, a wire coil is held on the scalp. A brief electrical current passes through~          the coil and creates a magnetic pulse that affects activity in the brain.~   "
110612|NCT02119624|"~     Background:~      - People who are dependent on alcohol drink even when they know something bad might happen.~     Researchers want to learn more about why they do this.~      Objectives:~      - To study brain response when a person plays a game in different threat conditions.~      Eligibility:~        -  Healthy right-handed adult heavy drinkers age 21 60~        -  Healthy right-handed adult light drinkers age 21 60~      Design:~        -  Participants will be screened with medical history, physical exam, and blood and urine~          tests. They will have an EKG and psychiatric interview.~        -  Participants will have one or two clinic visits.~        -  Participants will be asked about their alcohol drinking.~        -  They will choose a snack and alcoholic beverage that they must drink in 5 minutes. After~          their breath alcohol content (BrAC) is zero, they will play a game in the MRI scanner.~        -  The scanner is a metal cylinder that takes pictures of the brain. Participants lie on a~          table that slides in and out of the cylinder. They will be in it for about 90 minutes,~          lying still for up to 20 minutes.~        -  During the MRI, participants will play a simple computer game to earn food or drink~          points under different threats of electric shock. Points can be exchanged for food or~          alcohol after the game. Sometimes, participants will receive a mild electric shock~          through a metal disk on the wrist. Electric shocks will only happen if the participant~          tries to earn a reward point.~        -  After the MRI, participants use their points for another drink and snack. They will stay~          at the clinic until their BrAC is low, usually within 3 hours. Participants cannot drive~          themselves home.~        -  Participants will have a follow-up phone call the next day.~   "
110613|NCT02119611|"~     Background:~      - In deep brain stimulation (DBS), a device called a neurostimulator is placed in the chest.~     It is attached to wires in parts of the brain that affect movement. DBS might help people~     with movement disorders like Parkinson s disease (PD), dystonia, and essential tremor (ET).~      Objective:~      - To provide DBS treatment to people with some movement disorders.~      Eligibility:~      - Adults 18 years and older with PD, ET, or certain forms of dystonia.~      Design:~        -  Participants will be screened with medical history and physical exam. They will have~          blood and urine tests and:~        -  MRI brain scan. The participant will lie on a table that slides in and out of a metal~          cylinder with a magnetic field. They will be in the scanner about 60 minutes. They will~          get earplugs for the loud noises. During part of the MRI, a needle will guide a thin~          plastic tube into an arm vein and a dye will be injected.~        -  Electrocardiogram. Metal disks or sticky pads will be placed on the chest, arms, and~          legs. They record heart activity.~        -  Chest X-ray.~        -  Tests of memory, attention, concentration, thinking, and movement.~        -  Eligible participants will have DBS surgery. The surgery and hospital care afterward are~          NOT part of this protocol.~        -  Study doctors will see participants 3 4 weeks after surgery to turn on the~          neurostimulator.~        -  Participants will return every month for 3 months, then every 3 months during the first~          year, and every 6 months during the second year. Each time, participants will be~          examined and answer questions. DBS placement will be evaluated with MRI. The~          neurostimulator will be programmed. At two visits, participants will have tests of~          movements, thinking, and memory.~   "
110614|NCT02119598|"~     Research on prehospital telestroke systems is recommended by the American Stroke Association,~     as it may facilitate early stroke diagnosis, assessment of stroke severity and selection of~     patients for specific stroke treatments~      The experience with prehospital telemedicine for assessment of stroke severity is limited.~     Prehospital telestroke is a very promising concept, facilitating specialized stroke care in~     very early stage based on integration of bidirectional audiovisual communication with point~     of care laboratory analysis, vitals and decision support software.~      The aim of this prospective study is to investigate the safety, the technical feasibility and~     the reliability of in-ambulance telemedicine using a prototype third generation telemedicine~     system (PreSSUB 3.0).~   "
110615|NCT02119585|"~     During orthotopic liver transplantation (OLT), respiratory system function may be severely~     impaired for several reasons including anaesthesia effects, hyperdynamic volume state with~     fluid overload and ischemia reperfusion injury. In particular, reperfusion syndrome is~     characterised by the release of several inflammatory mediators such as cytokines and oxygen~     free radicals which may contribute to alveolar endothelial barrier dysfunction. The object of~     this study is to investigate the respiratory system mechanics impairment in its partitioning~     between lung and chest wall.~      We hypothesize that impairment of respiratory system mechanics (of both lung and chest wall)~     occurs after reperfusion phase of liver. This impairment is associated with the systemic~     inflammatory response following liver reperfusion.~   "
110616|NCT02119572|"~     The prevalence of diabetes has been growing rapidly in developing countries causing a~     devastating economic burden and increasing demands on healthcare systems. Therefore, there is~     an urgent need to find cost-effective and multi-faceted approach for diabetes care. Peer~     support models provide a potentially low-cost, flexible means that is complimentary to the~     current existing health care services. Trained peer leaders can become qualified extenders to~     a formal healthcare system, thereby, assisting with the education delivery and bolstering the~     efforts of the professional staff. To implement a culturally- specific peer support program~     and determine whether it is acceptable, cost-effective in China is important. This study aims~     to implement and evaluate biophysical and psychosocial outcomes of a peer support program and~     to explore it's feasibility and sustainability in China~   "
110628|NCT02119416|"~     Caffeine use is on the rise in America, and one of the most popular sources is soda. Among~     youth ages 8-16, caffeine consumption has increased by over 70% in the past 30 years. Few~     studies have examined the role of hormones in caffeine consumption within this age group.~      The purpose of the current experiment was to determine the effect of caffeine on children 8~     and 9 compared to those 15 and 16 years of age. The investigators were looking at the effect~     of puberty on the consumption of caffeine as well as the effect that the caffeine has on the~     body (for example: heart rate, blood pressure) and cognitive function.~   "
110629|NCT02119403|"~     To study the safety and efficacy of Hand Held Nitrous. A device that delivers 120 seconds of~     up to 72% nitrous oxide and ambient air.~   "
110864|NCT02116335|"~     Our bodies respond differently to stress. Animal studies by the investigators have found that~     endothelin-1 plays a role in regulating blood pressure in response to stress. This study is~     an extension of the investigators previous animal work to evaluate the role of endothelin-1~     during stress in humans.~   "
110617|NCT02119559|"~     In France, the incidence of head and neck squamous cell carcinomas (HNSCC) is 16 000 new~     cases/year. During these last years, many new chemotherapies and targeted therapies have been~     developed improving significantly the overall survival of patients notably anti-HER~     molecules. In inoperable recurrent and/or metastatic HNSCC, the best treatment is based on an~     anti-Human Epidermal Growth Factor Receptor (EGFR) antibody, targeting Human Epidermal Growth~     Factor Receptor 1 (HER1), the Cetuximab combined with platinum +/- 5 Fluoro Uracil (5FU): ~     Extreme protocol . However, no clinical or biological criteria predictive of drug efficacy~     have been reported yet. Thus, the development of such a predictive factor is an urgent need~     in HNSCC at both the clinical and pharmacy-economic level, to propose the best personalized~     treatment. One idea would be to enumerate and characterize the circulating tumor cells (CTC)~     which could give us an early evaluation of the therapeutic efficiency. In this context, the~     investigators have developed an innovative technology, the EPISPOT assay (patent of the~     University Medical Center of Montpellier), that allows the detection & characterization of~     viable CTC in the peripheral blood. The EPISPOT technology has been already evaluated in the~     breast and prostate cancer.Thus, the investigators would like for the first time to perform a~     prospective study on a cohort of patients treated following the Extreme protocol, with this~     technology, to assess the predictive value of CTC count. The investigators will use the~     CellSearch® system as the reference test.~   "
110618|NCT02119546|"~     The purposes of this study are:~        1. To investigate whether a 3-month exercise training program would improve cognitive~          function, motor performance, integrity of brain fiber tracts and cerebral blood flow;~        2. To investigate the possible neuro-anatomical and neurophysiological mechanisms of~          exercise training on cognitive function, motor performance, integrity of brain fiber~          tract and cerebral blood flow in patients with mild cognitive impairment and in those~          with early Alzheimer's disease;~        3. To investigate the influence of different apolipoprotein E (APOE) genotypes on the~          above-mentioned exercise effects.~      The results of this study will provide medical evidence for the effects of exercise training~     on mild cognitive impairment and on early Alzheimer's disease; and will provide understanding~     of the mechanisms mediating these effects. More importantly, the results serve as the basis~     for future larger-scale exercise clinical trials for these two patient populations.~   "
110619|NCT02119533|"~     Mild brain injury or concussion affects about four million Americans each year. Some people~     recover completely while others, especially those with multiple concussions, develop chronic~     headaches, neurodegenerative diseases and psychiatric disorders. One of the reasons that~     concussion is difficult to treat is that it is difficult to detect. Radiographic studies such~     as CT (computed tomography scan) are by definition unrevealing of structural injury in~     concussed patients. Some MRI (magnetic resonance imaging) sequences may be useful adjuncts in~     the diagnosis of concussion but even these are not consistently present in all patients with~     symptoms. Clinical tests for concussion often require baseline studies, and thus are~     generally reserved for athletes and others at highest risk for concussion.~      The investigators have developed a novel eye movement tracking algorithm performed while~     subjects watch television or a music video that determines whether the eyes are moving~     together (conjugate) or are subtly not together (disconjugate). The investigators preliminary~     data shows that people with lesions in their brain or recovering from brain injury have~     disconjugate gaze that is not detectable by ophthalmologic examination but is detected by our~     algorithm.~   "
110620|NCT02119520|"~     Current study was designed to evaluate the combined efficacy of PRF and 1.2% ATV gel with~     open flap debridement (OFD) in treatment of intrabony defects in chronic periodontitis~     subjects.~   "
110621|NCT02119507|"~     The purpose of this study is to evaluate the therapeutic benefit of Curodont Repair for the~     treatment of early approximal carious lesions compared to no treatment.~   "
110622|NCT02119494|"~     The purpose of this study is to assess the representation of COPD patients in terms of~     categories and phenotypes of the disease in selected countries in Central and Eastern Europe~     (CEE). The results of The POPE study will allow for evaluation of the differences in clinical~     approaches and treatment practices. The following countries are represented in The POPE~     study: Czech Republic, Slovakia, Austria, Poland, Hungary, Russia, Croatia, Serbia, Slovenia,~     Estonia, Latvia and Bulgaria.~   "
110623|NCT02119481|"~     The primary aim of this study is to examine the effects of a mindfulness-based stress~     reduction training program, delivered in individual web-based sessions, among breast cancer~     patients. The objectives are to study and answer questions regarding effects of the such~     training in a randomized controlled trial including the following outcome measures: physical~     and mental health status, perceived stress, post-traumatic stress symptoms, psychological~     well-being, and sleep quality. In addition to the primary aim, the investigators plan to~     explore potential mechanisms through which mindfulness training lead to improvement in~     perceived stress, well-being and sleep-quality. This will be studied by mediational analyses.~   "
110624|NCT02119468|"~     This phase I/II trial studies the side effects and best dose of ixazomib and to see how well~     it works when given together with pomalidomide and dexamethasone in treating patients with~     relapsed or relapsed/refractory multiple myeloma. Ixazomib may stop the growth of cancer by~     interfering with proteasomes (the protein breakdown mechanism in the cells). Pomalidomide and~     dexamethasone can modify and regulate the immune system and may stop cancer cells from~     growing. Giving ixazomib with pomalidomide and dexamethasone may be an effective treatment~     for relapsed or relapsed/refractory multiple myeloma.~   "
110625|NCT02119455|"~     Currently, orthodontic treatment typically lasts approximately 2 years. There are a number of~     advantages for reducing the duration of treatment, including reducing the potential risk of~     caries, root resorption and for minimizing patient burn out from prolonged treatment.~      While some evidence does exist that vibration may accelerate the speed of tooth movement, the~     biological mechanism is still unknown. Identification of specific factors involved in tooth~     movement that are further stimulated by vibration would help to understand the mechanisms~     involved as well as discover possible biologic targets which could be utilized or modified to~     maximize the benefits of vibration treatment.~      The purpose of this study is to identify novel biological factors that are expressed in~     patients undergoing orthodontic tooth movement in conjunction with vibration appliance~     therapy.~   "
110630|NCT02119390|"~     Although effective treatments are currently available to treat human immunodeficiency virus~     (HIV), the retrovirus leading to acquired immune deficiency syndrome (AIDS), strict adherence~     to the treatment regimen is required. Nonadherence to highly active antiretroviral therapy~     (HAART) regimens is well documented in individuals with HIV. This is especially true for~     adolescents and young adults (AYA), where rates of adherence range from 20 to 100%.~     Nonadherence has significant implications for subsequent treatment response and health~     outcomes, including poor virologic response, development of drug resistance, and mortality.~     Of note, previous research has suggested that every 1% increase in nonadherence is related to~     a 2% increased likelihood of detectable viral load (VL) in youth with behaviorally acquired~     HIV. Furthermore, higher VL is the most salient variable related to increased risk of virus~     transmission. Thus, nonadherence to HAART is a significant public health issue.~      The objective of the proposed research plan is to systematically examine an individualized,~     behavioral intervention targeting HAART nonadherence in AYAs initiating HAART. The current~     intervention will support AYA participation in brief, staff-delivered instruction in~     adherence-promotion skills. Individualized behavioral analysis and motivational interviewing~     will be applied to provide effective solutions for current barriers to HAART adherence before~     and after HAART initiation, as recommended by the Panel on Antiretroviral Guidelines for~     Adults and Adolescents.~   "
110631|NCT02119377|"~     This is an Internet-based survey of transgender and transsexual (trans) people aged 18 years~     and older living in Australia. This population has received limited attention from public~     health researchers, planners, and practitioners. However, a growing body of evidence suggests~     that trans people experience disparities in several important areas of health compared with~     the population generally. In particular, trans people are more likely to experience mental~     health problems (notably depression and anxiety disorders), use alcohol, tobacco, and illicit~     drugs, and think about or attempt suicide. Additionally, trans people commonly report that~     their physical and mental health needs are not met, and underutilise preventive health care.~      Participants were recruited using several non-probability sampling techniques, (including~     purposive sampling and snowball sampling), because random sampling is not possible with this~     population. Medical, social, support, and advocacy networks used by trans people were used to~     promote the study. A mixed quantitative and qualitative methodology was used. Validated~     quantitative instruments were used to obtain measures of health and well-being, which will be~     compared against population norms. Qualitative items complement these measures, providing~     rich experiential data.~      The investigators hypothesised that:~        -  the prevalence of depressive and anxiety disorders will be higher than for the~          population generally, and that these conditions will commonly be undiagnosed and~          untreated;~        -  depressive and anxiety disorders will be associated with risky behaviours, such as~          tobacco, alcohol, and illicit drug use; and,~        -  trans people will report poor relationships with medical practitioners.~      The investigators hypothesised that poor mental health is a consequence of several~     interrelated factors: body dysphoria (as a consequence of experiencing difficulty accessing~     medical treatment to alter sexual characteristics); societal discrimination and stigma~     (including harassment and violence); institutionalised discrimination (including difficulty~     changing identifying documents, and exclusion of surgical procedures and related treatments~     from public and private health systems); social isolation; and the belief held by many~     clinicians that transsexualism is a mental disorder (which may be a barrier to trans people~     forming trusting relationships with medical practitioners).~   "
110632|NCT02119364|"~     Cerebral palsy (CP) is the most common motor disability in childhood (2-3 per 1000 live~     born), and is frequently accompanied by cognitive impairments and behavioural problems. The~     present study is a controlled clinical trial, a multicenter-study involving three health~     regions, as well as the Norwegian University of Science and Technology (NTNU). Its primary~     research goal will be to evaluate the effects of computer-based cognitive training in~     children with CP. In addition, this study will be the first to conduct a comprehensive~     neuropsychological examination to improve our understanding of cognitive impairments as well~     as cognitive resources in CP children in Norway to aid in intervention planning.~   "
110633|NCT02119351|"~     The objective of this post-market, prospective study is to evaluate the clinical~     acceptability, blood leakage, risk for blood exposure, need for digital compression,~     insertion success, and clinical utility of the ViaValve™ Safety IV Catheter compared to~     standard hospital PIVCs currently being used.~   "
110634|NCT02119338|"~     The investigators propose a single-center, non-randomized, single-arm study at the Barrow~     Neurological Institute/St. Joseph's Hospital for recurrent glioma. The 5-ALA for recurrent~     glioma study will correlate presence of fluorescence in tumor tissue with pathological~     findings. This will be done using three cohorts in dose escalation. The investigators'~     hypothesis is that (for both low- and high-grade gliomas,) a lower dose of 5-ALA will result~     in less false positive fluorescence.~   "
110635|NCT02119325|"~     The primary aim of this study is to evaluate the effect of a fibre rich health food drink on~     the post prandial glucose and triglyceride peak in healthy overweight adults with impaired~     fasting glucose (IFG). The study is randomised, stratified, double blind, two treatments, two~     period cross over study.~   "
110636|NCT02119312|"~     The purpose of this study is to identify and screen potential subjects for preliminary~     eligibility to participate in a malaria related clinical trial conducted at the Seattle~     Malaria Clinical Trials Center (Seattle MCTC) or one of our partnering sites.~   "
110637|NCT02119299|"~     The purpose of this study is to demonstrate that (1) we will observe at least 40% of the~     subjects in the Per Protocol population having a measured ≥5% weight loss at 16 weeks~     compared to week 0; and (2) the observed mean % Total Body Weight Loss at 16 weeks compared~     to Week 0 is ≥4% in the Per Protocol population.~   "
110638|NCT02119286|"~     After screening, subjects will enter a 4 week open-label run-in period with fluticasone~     furoate (FF)/vilanterol (VI) 100/25 mcg administered once daily via dry powder inhaler (DPI).~     Subjects will then be randomized to receive any one of the 3 treatments (umeclidinium bromide~     [UMEC] [62.5 mcg] administered once daily via a DPI; OR UMEC [125 mcg] administered once~     daily via a DPI; OR matching placebo administered once daily via a DPI), while continuing~     treatment with open label FF/VI 100/25 mcg during a 12-week treatment period. There will be a~     total of eight scheduled clinic visits at Pre-Screening (Visit0), Screening (Visit 1),~     blinded treatment Day 1(Visit2), 2(Visit3), 28 (Visit4), 56 (Visit5), 84 (Visit6) and 85~     (Visit7). A follow-up phone contact will be conducted approximately 7 days after the last~     clinic visit. The total duration of subject participation in the study from Screening to~     Follow-up will be approximately 17 weeks.~   "
110699|NCT02118493|"~     The biliary system normally empties into the intestines, however, some patients have biliary~     system narrow areas (stenosis) that prevent the bile to drain normally. These may be~     related to an underlying disease or previous surgery. Patients with this problem usually~     require tubes to be inserted into the biliary system to drain bile into a bag outside of~     their body, impacting their quality of life.~      The purpose of this research study is to use a laser device to try to re-open the biliary~     drainage system.~   "
110640|NCT02119260|"~     This study is the first administration of GSK2798745 in humans. This will be a sponsor~     un-blinded, placebo-controlled study to investigate the safety, tolerability,~     pharmacokinetics (PK), and pharmacodynamics (PD) of GSK2798745, given as single and repeat~     oral doses to healthy subjects and stable heart failure (HF) subjects. Approximately 28~     healthy subjects will be enrolled in the study cohorts (Cohort 1-3) involving single and~     repeat dose escalations of GSK2798745, while up to 24 stable heart failure subjects will be~     enrolled in Cohort 4 involving single and repeat dose administration of GSK2798745, with the~     dose selected based on data from healthy subject cohorts. This would be followed by~     enrollment of up to 8 subjects with heart failure in Cohort 5 involving repeat dose~     administration of GSK2798745. The study duration, including screening and follow-up, is not~     expected to exceed 17 weeks for subjects in the study (in any cohort).~   "
110641|NCT02119247|"~     The purpose of this study is to compare the systemic availability to CHF 6001 after a single~     dose of CHF 6001 administered using the multi-dose NEXThaler® device or the single-dose~     capsule inhaler Aerolizer®.~      CHF 6001 is an antinflammatory drug under development for Chronic obstructive pulmonary~     disease (COPD) therapy. The drug is presented as dry powder for inhalation delivered by an~     inhaler device. Previous studies were conducted using a single-dose capsule inhaler~     (Aerolizer®) device. For the subsequent clinical studies a novel multi-dose NEXThaler® device~     will be used.~   "
110642|NCT02119234|"~     The study is performed to investigate the effect of the spacing device on the~     pharmacokinetics of CHF 5993 pMDI active ingredients administered with and without~     Aerochamber Plus Flow-vu antistatic VHC spacer as a single administration in COPD patients.~     Moreover, the general safety and tolerability of the treatments will be evaluated.~   "
110643|NCT02119221|"~     The study aims to provide understanding of the relative relevance of the different excretion~     pathways of Copanlisib in humans, as well as to characterize its metabolite profile.~   "
110644|NCT02119208|"~     1. In natural environment, the moderate-intensity break will allow a reduction of the~          caloric intake at the dinner more important than for the light-intensity break~        2. In natural environment, the break taken juste before dinner will allow a reduction of~          the caloric intake at the diner more important than earlier in the day.~   "
110645|NCT02119195|"~     A cohort of 20 patients aged 18 to 80 years (mean 28.35 years) of both genres females (65%)~     and males (35%) with 80 composite restorations were recruited at the Operative Dentistry~     Clinic at the Dental School of the University of Chile. All participants presented with~     marginal adaptation clinical features that deviated from the ideal and were rated Bravo~     according to the modified United States Public Health Service (USPHS) criteria for the~     sealing group and no treatment group. As a positive control were considered composites with~     alpha values in marginal adaptation. The protocol was approved by the Institutional Research~     Ethics Committee of the Dental School at the University of Chile (Project PRI-ODO-0207). All~     of the patients signed informed-consent forms and completed registration form. The selection~     criteria are summarized below.~   "
110646|NCT02119182|"~     The overall goal of Transforming Research and Clinical Knowledge in Traumatic Brain Injury~     (TRACK-TBI) study is to determine the relationships among the clinical, neuroimaging,~     cognitive, genetic and proteomic biomarker characteristics for the entire spectrum of TBI~     from concussion to coma. TRACK-TBI will validate biomarkers and outcome measures for clinical~     trials, advance diagnostic and prognostic models for TBI and improve clinical trial design.~   "
110647|NCT02119169|"~     The effectiveness of pigtail catheter as a less invasive option for pleural drainage in~     patients with resistant hepatic hydrothorax.~   "
110648|NCT02119156|"~     This study will assess the effect of a 24-week withdrawal followed by a 28-week~     reintroduction of belimumab 10 mg/kg plus standard of care medications in subjects with~     stable low systemic lupus erythematosus (SLE) disease activity. Rebound phenomenon will be~     assessed for subjects who have permanently withdrawn from further belimumab treatment.~   "
110649|NCT02119143|"~     This study investigates the effects of a dietary supplement - a cocktail of vitamins and~     minerals - on the incidence of common cold in a cohort of middle management employees.The~     primary outcome is defined as the number of duty days lost due to common cold/flu. Further,~     immune parameters and markers of redox biology/oxidative stress will be determined. The~     wellbeing in the cohort will be evaluated via questionnaires.~   "
110650|NCT02119130|"~     The purpose of this study is to use a cluster randomized trial to compare the effectiveness~     of linking the Quantiferon-gold in-tube test (QGIT) with routine CD4 testing to the routine~     use of the tuberculin skin test (TST), the current standard of care for diagnosing latent~     tuberculosis infection (LTBI) in South Africa. The investigators hypothesize that QGIT~     clinics will identify LTBI and initiate isoniazid preventive therapy (IPT) in a higher~     proportion of patients and in a significantly faster timeframe. The cost-effectiveness of~     linking QGIT with routine CD4 compared to routine TST will also be evaluated, and the process~     of implementation of QGIT into the routine cluster of differentiation 4 (CD4) blood draw will~     be evaluated using a mixed method approach to identify steps that can be modified for future~     scale-up of the intervention.~   "
110651|NCT02119117|"~     Pregnancy rates for women over 35 years old are significantly lower when compared to younger~     women. One of the causes for this decrease is believed to be chromosomal aneuploidy.~     Chromosomal aneuploidy is a natural phenomena and occurs in women of every age and has been~     implicated in spontaneous miscarriages, and preimplantation embryo wastage (Hassold and Hunt,~     2001).~      As maternal age increases, so too does the incidence of chromosomal aneuploidy. Embryo~     quality from older patients undergoing IVF tends to be reduced and associated with higher~     rates of chromosomal abnormalities when compared to good quality embryos (Munne et al.,~     1995).~      Chromosomal aneuploidy derives from the improper segregation of chromosomes during~     preimplantation development. The process of segregation, or mitosis, includes synthesis of~     the complete genome, equal division of chromosomes to opposite poles by the spindle~     apparatus, and separation of the two cells by cytokinesis, yielding two chromosomally~     identical cells. The entire process of cellular and genetic replication requires energy in~     the form of adenosine tri phosphate (ATP). ATP is mainly produced in mitochondria in the~     process known as the electron transport chain (ETC). There are many important molecules~     required for ATP production, CoQ10 can act as the appropriate carrier of electrons through~     the ETC. When a deficiency in CoQ10 is present, ATP production is decreased resulting in~     aneuploidy (Bentov et al., 2013). Similarly, research has shown that chromosome alignment and~     spindle formation are affected by mtDNA copy number (Ge et al., 2012). It has also been shown~     that the transfer of ooplasm from young, healthy oocyte donors into oocytes of women with~     repeated embryonic failure has result in children with subsequent mitochondrial heteroplasmy~     (Cohen et al., 1998).~      CoQ10 concentrations have been shown to decrease as age increases (Bentov et al., 2011).~     Consequently, the decrease in CoQ10 concentrations seen in older women may cause an increase~     in chromosomal aneuploidy in subsequent embryos (Bentov et al., 2013). In this pilot study,~     we test the hypothesis that the supplementation of CoQ10 prior to an IVF cycle can increase~     mitochondrial DNA activity and possibly decrease chromosomal aneuploidy in AMA patients.~   "
110653|NCT02119091|"~     A double-center, randomized, double-blinded, 2-way crossover, placebo-controlled Study:~     Comparison of single oral dose 400mg Moxifloxacin-induced QT prolongation between healthy~     Chinese volunteers and Caucasian Volunteers Study Objective:Primary Objective:To compare the~     difference of ΔΔQTcF (Baseline-adjusted, placebo-corrected effect on QTcF) between Chinese~     group and Caucasian group under the same exposure (Cmax) of Moxifloxacin.Secondary~     Objectives:1)To compare the difference of ΔΔQTcF, heart rate, PR, RR, QRS and Moxifloxacin~     plasma concentration between Chinese group and Caucasian group.2)To compare slopes of~     Moxifloxacin plasma Concentration/QTcF value between healthy Chinese volunteers and Caucasian~     Volunteers.~   "
110654|NCT02119078|"~     The purpose of this investigation is to assess the effectiveness of a multi-disciplinary~     Acute Care for Elders (ACE) program dedicated to the care of patients age 70 and older~     admitted to Oregon Health & Science University's hospital medicine service. The ACE program~     will aim to improve the quality of care of older patients in the investigators hospital by~     implementing focused interventions and recommendations specific to geriatric needs and~     syndromes, including: reduced fall rate, decreased incidence and duration of delirium, early~     recognition and treatment of impaired mobility and function, careful minimization of~     medication use, prevention of unnecessary catheter and restraint use, decreased hospital~     readmission rates, improved transitional care following hospital discharge, and high levels~     of patient and referring physician satisfaction. Additionally, the ACE program aims to~     improve resident and student competence in treating geriatric syndromes, and to improve staff~     and learner satisfaction with caring for older adults. ACE programs have been well studied at~     other institutions, so the investigators will be implementing a program that is already~     standard of care, and studying the elements that are unique to OHSU.~      This will be a quality improvement project. Study participants will be a convenience sample~     of OHSU faculty, staff, residents and students who are employed by or on rotation with~     General Medicine Team 1 of the Medicine Teaching Service. Faculty, staff, and learners (ACE~     team members) will receive the ACE training. Study personnel will conduct prospective and~     retrospective chart review of patients admitted to the ACE service to determine outcomes as~     noted above.~   "
110655|NCT02119065|"~     This pilot clinical trial studies positron emission tomography (PET)/computed tomography (CT)~     in finding beads after Yttrium-90 bead therapy in patients with primary liver cancer or~     cancer that has spread to the liver (metastatic) that can not be removed by surgery. Imaging~     procedures, such as PET/CT after Yttrium-90 bead therapy, may help see if the beads are~     present in the lung and compare the results with the pre-therapy imaging.~   "
110656|NCT02119052|"~     Autosomal dominant polycystic kidney disease (ADPKD) is associated with the development of a~     variety of extrarenal manifestations of which polycystic liver disease is most common. The~     investigators aimed to assess the changes over time of liver volume in ADPKD patients and~     whether it is affected by the treatment with the somatostatin analogue, octreotide.~      35 ADPKD patients (14 males) aged 34±8 years were randomly assigned to 36 month treatment~     with placebo (n=18) or octreotide (n=17). Clinical and liver parameters at magnetic resonance~     (RM) were evaluated at baseline, study end and after 24 months of drug withdrawal.~   "
110657|NCT02119039|"~     CACICOL20 is an ophthalmic solution based on the technology of RGTAs (ReGeneraTingAgents). It~     consists of large biopolymers, imitating the structure of heparansulphate. The protecting~     effect on different biological tissues and enhancement of wound healing has been described in~     several studies.~      Keratoconus is a relatively common disease, with incidences ranging from 1.3 to 25 per~     100,000 per year across different populations. Corneal collagen cross-linking represents a~     treatment option for these patients, aiming to prevent progression of the disease via~     stabilization of corneal microstructure. Corneal epithelial removal prior to the ultraviolet~     A/riboflavin cross-linking procedure significantly improves the outcome of the intervention,~     due to ameliorated distribution of riboflavin.~      The aim of the present study is to investigate the effect of CACICOL20 on corneal epithelial~     wound closure after collagen cross-linking in patients with keratoconus. Results may lead to~     an improved management and pain reduction of patients with corneal epithelial defects.~   "
110658|NCT02119026|"~     Since its introduction, 5-fluorouracil (5-FU) has been the cornerstone of treatment for~     metastatic colorectal cancer (mCRC). Meanwhile the oral 5FU pro-drug Capecitabine (Xeloda®)~     proved equivalence to 5-FU and is a well tolerated alternative combination partner for~     Irinotecan (XELIRI) or Oxaliplatin (XELOX) which are widely used for first line treatment of~     mCRC. Recent advances in molecular biology have resulted in the development of an inhibitor~     of the vascular endothelial growth factor (VEGF) by the monoclonal humanized antibody~     bevacizumab (Avastin®).~      XELOX or XELIRI +bevacizumab have been investigated in several trials, but not in an approach~     with clearly defined cross-wise XELIRI-XELOX change criteria. This trial investigates two~     different sequential treatment options with XELIRI/ XELOX in first and second line with the~     addition of bevacizumab and tries to give answer to the question if there is an optimal~     sequence for the benefit of the patient.~      This is a prospective, randomized, open-label, 2-arm pilot trial in patients with mCRC who~     did not receive systemic treatment for their metastatic disease. The study is designed to~     evaluate the efficacy of XELIRI followed by XELOX and XELOX followed by XELIRI + bevacizumab~     in terms of Duration of Disease Control (DDC).~      Patients will be treated with an established first line therapy consisting of either XELOX or~     XELIRI + bevacizumab. The chemotherapy treatment will be given for 6 months except prior~     disease progression, unacceptable toxicity or patient refusal. Bevacizumab will be given~     until disease progression, unacceptable toxicity or patient refusal.~      Capecitabine can be given in addition at the investigators' discretion until disease~     progression, unacceptable toxicity or patient refusal.~      If serious side effects occur despite adequate dose reduction, Oxaliplatin or Irinotecan~     should be discontinued. In case of Oxaliplatin or Irinotecan-related discontinuation~     Capecitabine and Bevacizumab should be continued. If Capecitabine also has to be discontinued~     in first line treatment bevacizumab should be continued. In case of permanent discontinuation~     of bevacizumab for toxicities, chemotherapy should be continued.~      Upon completion of first line chemotherapy patients with disease control will receive~     bevacizumab maintenance treatment. On investigators decision patients can receive~     Capecitabine as additional maintenance treatment.~      The primary endpoint is to determine the efficacy of a modified XELIRI + bevacizumab followed~     by XELOX + bevacizumab scheme at progression in comparison with the reverse sequence based on~     DDC.~      Secondary endpoints are first line progression-free survival (PFS), second line PFS, overall~     response rate, time to response, duration of response, overall survival, tumor assessments~     (based on RECIST criteria) using CT scans, MRI scans, X-ray, bone scan, clinical examination.~   "
110659|NCT02119013|"~     Autosomal dominant polycystic kidney disease (ADPKD) is associated with early onset~     hypertension and left ventricular (LV) hypertrophy. Since LV hypertrophy is associated with~     LV diastolic function impairment, we aimed to assess the changes over time of LV diastolic~     function in ADPKD patients and whether they were affected by the treatment with the~     somatostatin analogue, octreotide.~      35 ADPKD patients (14 males) aged 34±8 years (mean glomerular filtration rate 82±26~     mL/min/1.73m2) were randomly assigned to 36 month treatment with placebo (n=18) or octreotide~     (n=17). Clinical and echocardiography parameters were evaluated at baseline and study end. LV~     mass (M) and ejection fraction (EF) were calculated according to Devereux formula and biplane~     Simpson's algorithm, respectively. LV filling was assessed by mitral and pulmonary vein flow~     velocity curves and mitral annulus early diastolic velocity peak (Ea) by tissue Doppler~     imaging.~   "
110660|NCT02119000|"~     Bowel preparation is a crucial step prior to colonoscopy to help with the optimal assessment~     of the colonic mucosa. Inadequate bowel preparation increases the length of the procedure,~     and is associated with decreased lesional detection rates. The ideal bowel preparation~     formulation should be able to completely clean the bowel, without leaving solid or liquid~     residues, and without modifying the mucosal appearance.~      Bowel preparation may be administered in hospitalised patients or in the ER. Patients have~     less control on their environment and the intake of the bowel preparation. For example, there~     may be a delay in pharmacy delivery or inadequate supervision by the treating personnel.~     Hospitalised patients have more comorbidities, are usually less autonomous and mobile - both~     can add to the barriers leading to an adequate bowel preparation. Multiple studies have~     identified hospitalization status as an independent risk factor for poor bowel preparation.~      The objective of this study is to access which bowel preparation regimen, between PEG 3350~     with electrolytes 2L the day before and 2L the day of the colonoscopy vs bisacodyl + PEG 3350~     with electrolytes 1L the day before and 1L the day of the colonoscopy, results in the~     cleanest bowel preparation in hospitalised patients.~   "
110661|NCT02118987|"~     This research study is evaluating a drug called omalizumab (brand name 'Xolair') as a~     potential treatment to be used in conjunction with drug desensitization to prevent reactions~     from recurring and allowing the participant to be treated with the chemotherapy the~     participant's oncologist prefers to give.~   "
110662|NCT02118974|"~     Robotic-assisted surgery is becoming more prominent within the specialty of Gynecologic~     surgery with little direct evidence that it is if not better than traditional laparoscopic~     surgery, at least equivalent. We designed a randomized-controlled trial to compare operative~     times, length of hospital stay, estimated blood loss, and post-operative complications~     associated with these two methods of minimally invasive hysterectomy.~   "
110663|NCT02118961|"~     This study is designed to assess the immunogenicity and safety of DTaP vaccine (BK1301) as a~     booster dose in adolescents.~      The purposes of this study are as follows:~        -  To confirm the non-inferiority of BK1301 to Adsorbed Diphtheria-Tetanus Combined Toxoid~          (DT toxoid) with respect to booster responses for anti-diphtheria toxoid (anti-D) and~          anti-tetanus toxoid (anti-T) antibodies~        -  To confirm that booster responses for anti-pertussis toxoid (anti-PT) and~          anti-Filamentous Hemagglutinin (anti-FHA) antibodies are more than 80% of participants~          received BK1301~   "
110664|NCT02118948|"~     The purpose of this study is to develop and evaluate an HIV risk reduction intervention for~     women with a history of abuse.~   "
110665|NCT02118935|"~     The study is intended to measure infant comfort, behavior, and sleep when consuming study~     formula with prebiotics compared to infants who consume a study formula without the~     prebiotics.~   "
110666|NCT02118922|"~     We have developed novel Brillouin microscopy and we are testing its potential for keratoconus~     and ectasia diagnostics. We plan to perform axial scans of the cornea in human volunteers in~     order to compare biomechanical properties of Keratoconus vs. Normal corneas and compare~     biomechanical properties of post-LASIK ectasia vs. normal corneas.~   "
110667|NCT02118909|"~     This study is designed as a 2-part, open-label study to assess the effect of pracinostat with~     itraconazole (part 1) and pracinostat with ciprofloxacin (part 2) on the bioavailability of~     pracinostat. Secondarily to evaluate the safety and tolerability of pracinostat administered~     with itraconazole or ciprofloxacin.~   "
110668|NCT02118896|"~     The purpose of this study was to offer patients who had participated in one of the phase II~     PK or phase III studies on FK506E (MR4) the possibility to continue FK506E (MR4) until~     commercial availability of the drug and to record long term efficacy and safety data.~   "
110669|NCT02118883|"~     The purpose of this study is to examine and compare the rehydration effect of Essentia Water,~     an electrolyzed high-pH bottled water, with industry-standard bottled water purified by~     reverse osmosis with minerals added, on (1) whole blood viscosity, (2) plasma osmolality, (3)~     bioelectrical impedance analysis, and (4) body mass change, using serial measurements in~     apparently healthy adults following exercise-induced dehydration in a controlled environment.~   "
110670|NCT02118870|"~     Background:~      The optimal duration of dual antiplatelet therapy in ACS patients treated with DES is still~     under debate. This is especially true for STEMI patients in the era of new anticoagulants and~     antiplatelet agents. Yet, the potential benefits of longterm dual antiplatelet therapy in~     avoiding thrombotic complications may be clearly counterbalanced by a higher risk of major~     bleeding complications. In particular, the COMBO dual therapy stent, being associated with~     early re-endothelization, may allow for a reduction of the duration of DAPT (dual anti~     plateled therapy) without increasing the thrombotic risk, while reducing the risk of severe~     bleeding complications.~      Study Objective:~      Aim of the current study is to demonstrate a non-inferiority of a strategy of short-term DAPT~     (90 days) as compared to standard 360 days DAPT in ACS patients treated with Combo stent.~      Study Design:~      This study is a prospective, multicenter, randomized, investigator-initiated study designed~     to enroll 1500 patients with ACS receiving a COMBO dual-therapy stent who will be randomized~     1:1 to either short term (90 days) or to standard (360 days) DAPT. Patients will be~     randomized within hospitalization (before discharge in case additional revascularization is~     deemed necessary and performed during hospitalization). Clinical visit is scheduled at 90,~     and 360 days, whereas a telephone contact will be performed at 180 and 720 days.~      Patient Population:~      The study population will consist of up to 1500 ACS patients (male and female) older than 18~     years amenable to percutaneous treatment and treated with a COMBO stent. Subjects must meet~     all of the eligibility criteria and provide written informed consent.~   "
110671|NCT02118857|"~     The human body houses a huge microbial ecosystem, including the intestinal and oral~     microbiota. Both these ecosystems, and, in particular, the intestinal one, are responsible~     for maintaining human health. The response of the organism to the diet and the relative~     alteration of the susceptibility to disease are worth of investigation to comprehend the role~     of the microbiota to maintain the state of well being in humans. This concept, which is the~     overall scientific basis of the entire project, perfectly fits with the declared scopes of~     Horizon 2020. Understanding the impact of omnivore, vegetarian and vegan diets on human~     intestinal microbiota is aligned to the Grand Societal Challenge of the Horizon 2020 scheme,~     which is addressing the human nutritional needs and the impact of food on human physiological~     functions. In particular, studying the link between dietary habits and the intestinal~     microbiota activity will be pivotal to improve the food-based promotion of health and well~     being. The project aims at studying how the omnivore, vegetarian and vegan diets may affect~     the oral intake of microorganims, and the composition of the oral and fecal microbiota. With~     the aim to build up a permanent European platform for such type of studies, ten Research~     Units (RUs) are involved in the proposal, with the partnership of 16 National and,~     especially, foreign Institutions, covering 12 different countries. About 50 omnivore,~     vegetarian and vegan volunteers, for a total of 150 subjects will be recruited. Volunteers~     will be asked to fill in diaries, describing their dietary habits, and to collect biological~     samples (saliva, feces and urine), once a week for three weeks. For obvious ethical~     constraints, biopsies will be not available in this study. RUs will share their tasks, mainly~     depending on the nature of the samples to be studied, namely foods and biological samples.~     Based on the different dietary habits, the presumptive intake of microorganims will be~     estimated using literature data and, especially, culture-dependent methods. Typing and~     antibiotic resistance of some food related microbial communities or foods will be also~     investigated. The microbial diversity of foods, whose microbiota has never been studied in~     depth, will be characterized by PCR-DGGE and deep sequencing. The metabolome characterization~     will complete the overview on foods. After collecting and preparing biological samples from~     the three diet groups, the oral and fecal microbiota will be studied. The viable cell number~     of several microbial groups will be estimated in fecal samples, before freezing.~     Preliminarily, the microbial diversity of saliva and fecal ecosystems will be analyzed~     through PCR-DGGE. PCR assessment of genetic basis of antibiotic resistance will be also~     carried out. Selected numbers of biological samples will be further subjected to next~     generation sequencing, aiming at determining representative individuals/samples of the three~     types of diet. Only for feces, representative samples (e.g., 4/5 for each diet) will be~     subjected to meta-omics analyses based on meta-genomic, meta-transcriptomic and~     meta-proteomic approaches. An integrated and iterative workflow will be also developed, by~     assembling an in house synthetic meta-genome. The functionality of fecal samples and/or of~     isolates from feces will be characterized based on fecal genotoxic and anti-genotoxic~     activities, and modulation of the immune response. In agreement with an holistic approach,~     the metabolome analysis of saliva, feces and urine will complete the characterization of~     biological samples. All data available from the different RUs will merge into a common~     database, whose structure will be developed during the project. Based on the literature data~     (ISI Web of Knowledge), this is the first study that aims at correlating the effect of the~     main dietary habits on the oral and fecal microbiota through integrated meta-omics analyses.~   "
110672|NCT02118844|"~     The purpose of this study is to determine whether deep neuromuscular blockade compared to~     moderate neuromuscular blockade may improve the surgical conditions in patients undergoing~     laparoscopic bariatric surgery.~   "
110673|NCT02118831|"~     Comparable data for bevacizumab and aflibercept are lacking, as are studies comparing the~     systemic levels of ranibizumab, bevacizumab, and aflibercept and their relative effects on~     circulating vascular endothelial growth factor. In the present prospective study, the~     investigators evaluated serum drug levels and plasma free vascular endothelial growth factor~     (VEGF) levels in patients with neovascular age-related macular degeneration following~     intravitreal injections of ranibizumab, bevacizumab and aflibercept.~   "
110674|NCT02118818|"~     Rheumatic fever (RF) is an autoimmune disease that is mediated by the cellular and humoral~     immune response that follows an untreated pharyngeal Streptococcus pyogenes infection. The~     most serious complication is rheumatic heart disease (RHD), one of the most common problems~     facing children and young adults worldwide, which leads to chronic valvular lesions. It is~     estimated that 60% of all acute rheumatic fever cases will develop RHD.~      The pathogenesis of RHD is complex with both environmental and genetic factors contributing~     to its etiology. The investigators know little about the genetic etiology, cellular events~     and modifiers of progression of RHD, and there exists a wide range of disease severity and~     progression to severe valve pathology.~      Thus, the investigators will study the genetics of RHD in Rwanda, a country with a very high~     incidence of RHD, using a combination of next-generation targeted exome capture,~     transcriptomics, and expressed quantitative trait loci (eQTL) analysis.~   "
110675|NCT02118805|"~     This study is evaluating the use of two painless, non-invasive technologies in the assessment~     of muscle health over time in both healthy volunteers and patients who have diseases that~     affect the nervous system.~   "
110676|NCT02118792|"~     The purpose of this study is to investigate the safety and efficacy of AN2728 Topical~     Ointment, 2% in children, adolescents, and adults (ages 2 years and older) with atopic~     dermatitis.~   "
110677|NCT02118779|"~     Myotonic dystrophy type1 (DM1) is a rare, inherited, chronic progressive disease as well as~     an autosomal dominant multisystemic disorder. It is the most common adult form of muscular~     dystrophy, with a prevalence of approximately 10 per 100,000 people affected. With 733~     million people in Europe, we estimate that 75,000 people are DM1 patients in Europe.~      The aim of OPTIMISTIC is to improve clinical practice in the management of patients with this~     rare disease for which no dedicated treatment is currently available. OPTIMISTIC is a~     multi-centre, randomised controlled trial designed to compare a two component tailored~     behavioural change intervention to increase physical activity against standard patient~     management regimes, with particular attention given to the definition of appropriate outcome~     measures and new clinical guidelines for DM1 management. The two components of the~     intervention are 1) cognitive behavioural therapy (CBT) and 2) graded physical activity and~     we will evaluate the intervention's effectiveness and safety against standard patient~     management.~      Participants will be recruited from myotonic dystrophy clinics and neuromuscular centres in~     France, Germany, the Netherlands and the UK. A total of 286 male and female patients aged 18~     years and older with genetically proven classical or adult DM1 suffering from severe fatigue~     (only DM1 patients with a CIS subscale fatigue score > 35 are likely to benefit from the~     intervention), able to walk independently and able to complete the trial interventions will~     be included.~      A key objective of OPTIMISTIC is to provide outcome measures that are relevant for the~     patients and have a rate of change that is appropriate for a clinical trial timeframe. In~     addition, OPTIMISTIC will identify genetic factors that predict outcome and potential~     biomarkers as surrogate outcome measures that best explain the observed clinical variation.~   "
110678|NCT02118766|"~     The purpose of this study is to investigate the safety and efficacy of AN2728 Topical~     Ointment, 2% in children, adolescents, and adults (ages 2 years and older) with atopic~     dermatitis.~   "
110679|NCT02118753|"~     In the laboratory, the researchers will investigate whether the drug eplerenone improves~     contractile function after ischemia and reperfusion in heart tissue.~   "
110680|NCT02118740|"~     This is a observational study in which healthy found volunteers are recruited to donate 50 ml~     of bone marrow aspirate to enable preclinical studies to obtain proof of concept and safety~     of a bone marrow derived stem cell preparation named AMARCELL. The prepared AMARCELL is only~     for animal studies and after completion of the preclinical program, the intention of AMARCELL~     is to treat humans with a traumatic Spinal cord injury.~   "
110681|NCT02118727|"~     The purpose of this study is to determine if memantine at 20 mg BID when used in conjunction~     with riluzole, can slow down the disease progression of patients with ALS including~     potentially improving their neuropsychiatric changes, as well as determine if CSF protein~     biomarkers can be used both as a diagnostic and a prognostic marker in patients with ALS.~      Funding Source-FDA OOPD~   "
110682|NCT02118714|"~     This study is being conducted to evaluate the effects of Atrasentan on sperm production and~     the function of the testicles in male subjects with Type 1 or 2 Diabetes and Nephropathy.~   "
110683|NCT02118701|"~     Shared Decision Making (SDM) is defined as a process where healthcare professionals and~     patients make decisions together, using the best available evidence. SDM, as a communication~     and decision method, can be used also with persons suffering from dementia. Yet, SDM with~     persons with dementia or even with their family caregivers is not widespread.~      The present research project aims to develop and evaluate an SDM framework in care planning~     to be implemented in long-term care facilities, in order to obtain a constantly developing~     care plan that focuses not only on the medical, physical, psychosocial and spiritual needs of~     the resident, but that considers and documents his preferences and the actions taken by~     caregivers to meet them.~      The current project is a controlled exploratory study. Case studies that involve a triad in~     each case, composed by the resident with moderate or severe dementia, his family caregiver~     and the professional usually taking care for the resident, will be used (n=16 professionals;~     n=40 residents; n=40 family caregivers). Professional caregivers of two nursing homes, one~     located in Italy and one in the Netherlands, will receive a specific training in SDM~     principles and will guide the SDM interview within the triad. Primary outcome will be the~     proportion of residents whose preferences and needs, together with the related actions to~     meet them, are known, documented and satisfied in their 'life-and-care plans'. Secondary~     outcomes are the residents' and family caregivers' quality of life; the family caregivers'~     sense of competence and the healthcare professionals' job satisfaction. Semi-structured~     interviews and focus group interviews will be performed to assess satisfaction with the~     intervention and barriers and facilitators to its implementation. Assessments are performed~     at baseline and six months after the intervention.~      We hypothesize that the use of the SDM process in care planning will increase the number of~     met needs and will improve the residents' and family caregivers quality of life, the family~     caregivers' sense of competence and the healthcare professionals' job satisfaction.~      The key element of this study is that it will contribute to our knowledge about the efficacy~     and feasibility of an SDM framework in care planning in long-term care facilities with~     persons with moderate to severe dementia.~   "
110684|NCT02118688|"~     The purpose of this randomized clinical trial is to determine whether risperidone alone,~     trazodone alone, or a combination of risperidone and trazodone is superior for the treatment~     of ICU acquired delirium. The hypothesis is that combination therapy is superior to either~     agent alone in treating ICU acquired delirium and sustaining delirium free time.~   "
110685|NCT02118675|"~     The study is to collect the body composition data using five different methods-bioimpedance~     analysis (Tanita®), DXA (GE Medical), BodPod (Life Medical), deuterium dilution (heavy~     water), body circumferences (tape measure, TC2), and tissue thickness by ultrasound (GE~     Medical, BodyMetrix).~   "
110686|NCT02118662|"~     The study is designed to measure the energy expenditure associated with a common office task~     (i.e., typing) while 1.) seated in an office chair, 2.) pedaling using a prototype pedal~     desk, and 3.) walking on a treadmill.~   "
110687|NCT02118649|"~     Participants will play a computer game that is controlled by their gaze patterns and designed~     to direct attention their attention to specific on-screen targets. Visual attention to~     targets will be rewarded. Both visual behavior and brain response will be recorded during~     game play.~      It is hypothesized that that, over the course of the game, relative to baseline, participants~     will show (a) increased looking to targets, (b) decreased response time to targets, and (c)~     enhanced, more efficient neural response to visual cues. It is hypothesized that clinical~     variability will associate with visual attention and brain response.~   "
110688|NCT02118636|"~     Early stage hormone receptor positive breast cancer is typically treated with adjuvant~     endocrine therapy in order to decrease risk of breast cancer recurrence and to improve~     overall survival from the disease. Typical agents used for treatment include tamoxifen and~     the aromatase inhibitors. In postmenopausal women, aromatase inhibitor therapy is~     increasingly common because it is associated with fewer long-term serious toxicities compared~     to tamoxifen. However, aromatase inhibitors cause arthralgias in 40-50% of patients, which~     can influence adherence to therapy and can lead to treatment discontinuation in a minority of~     cases. The mechanism underlying development of this toxicity remains unclear, and predictors~     of who will develop these symptoms remain undefined. This observational study is designed to~     collect patient-reported outcomes and serial serum samples in order to investigate potential~     etiologies of this bothersome toxicity.~   "
110689|NCT02118623|"~     This study will examine if there is a benefit of an online intervention for persons with~     bipolar diagnoses, and what components appear to be most useful.~   "
110690|NCT02118610|"~     Schizophrenia is a devastating and complex illness, with multiple symptom and behavioral~     manifestations. Antipsychotic medications are the mainstay of treatment; however, many~     patients only partially respond to treatment. Development of new treatment has not progressed~     rapidly, in part, because the underlying etiopathophysiology of the illness is not well~     understood. To date, all pharmacological treatments approved for use in schizophrenia involve~     primary modulation of the dopamine system. Many agents without dopamine action have failed to~     demonstrate efficacy. There is growing evidence that schizophrenia may be, in part, due to an~     inflammatory process and pharmacological treatment approaches that decrease inflammation have~     shown promise. Thus, treatments that may have anti-inflammatory properties (e.g., TNF-alpha~     inhibition), but also possess dopamine modulation may prove to be beneficial. This novel~     medication, l-tetrahydropalmatine (l-THP), has robust anti-inflammatory properties,~     particularly TNF-alpha and ICAM inhibition; has antiprotozoal activity; and possesses an~     antipsychotic-like pharmacological profile of D1, D2 and D3 receptor antagonism. The high~     affinity of l-THP for D1 versus D2 receptors distinguishes it from first generation~     antipsychotics and its D1 to D2 ratio resembles that of the superior antipsychotic,~     clozapine. Also, an almost identical compound, l-stepholindine (l-SPD), demonstrates robust~     antipsychotic activity in humans (both positive and negative symptoms) and is currently used~     clinically in China. l-THP has been used for over 40 years clinically in China, has a good~     safety profile to date, and represents a novel and exciting mechanism for schizophrenia~     treatment. Initial safety data from our phase I study of l-THP (20 healthy controls) shows~     excellent tolerability and lack of any substantial side effects. L-THP has been tested in~     outpatient drug abuse trials for 4 weeks with good safety data, (Hu et al 2006, Yang et al~     2003). Yang et al (2003) randomized this medication in over 120 participants for 4 weeks with~     4 week observation without any notable side effects.~      We will test this compound (30 mg BID) as an adjunct treatment in a randomized, double-blind,~     4-week trial, in which we will assess treatment efficacy, changes in peripheral cytokine~     concentrations, and, secondarily, antiprotozoal effects, (antibody titers to Toxoplasma~     gondii), an infection that is known to occur at higher rates in schizophrenia than healthy~     controls and may be related in part to the illness.~   "
110691|NCT02118597|"~     This prospective, national, multicenter, non-interventional study examined the use of triple~     combination therapy with boceprevir, pegylated interferon (peginterferon) alfa-2a and~     ribavirin in re-treating participants with genotype 1 chronic hepatitis C (CHC) infection.~     Dosing and treatment duration were at the discretion of the investigator in accordance with~     local clinical practice and local labeling. Participants were to be observed for the duration~     of their triple combination therapy and for up to 24 weeks thereafter.~   "
110692|NCT02118584|"~     This two-part, part 1: open-label extension (OLE) and part 2: safety monitoring (SM) study~     will examine the efficacy and safety of continued etrolizumab treatment in moderate to severe~     ulcerative colitis (UC) participants previously enrolled in etrolizumab Phase II/III studies.~     Participants with moderate to severe UC who were enrolled in the Phase II OLE study (GA27927~     [NCT01461317]) or the Phase III studies (GA28948 [NCT02163759], GA28949 [NCT02171429],~     GA28950 [NCT02100696], GA29102 [NCT02165215], and GA29103 [NCT02136069]) were included.~     Participants from the Phase II OLE study or the Phase III studies who are not eligible or~     willing to receive etrolizumab in the OLE-SM study, and who have completed the 12-week safety~     follow-up period will be enrolled in Part 2. Part 1 of OLE-SM will continue for up to 7 years~     after the first participant is enrolled into the study. Following Part 1, participants will~     enter Part 2 for a period of 92 weeks.~   "
110693|NCT02118571|"~     The objective of this protocol is to develop items for a patient-reported outcome (PRO)~     measure to assess the patient's perspective and subjective experience of cognitive impairment~     associated with schizophrenia (CIAS).~   "
110694|NCT02118558|"~     This trial is a prospective, single center, unblinded, randomized, controlled study to assess~     the safety and efficacy of negative pressure wound therapy in preventing infections after TKA~     surgery . The study will enroll 316 patients that will undergo TKA. patients will be~     randomized to the treatment group and undergo the study intervention - (NPWT) The~     intervention will take place at the end of the surgery. The Patients that are randomized to~     the control group will receive standard treatment. Both groups will be assessed at two weeks~     and six weeks. period.~   "
110695|NCT02118545|"~     vWF is stored in weibel-palade-bodies of endothelial cells as well as alpha-granula of~     platelets and is released upon their activation. Endothelial cell dysfunction as well as~     platelet activation often occur in liver disease and portal hypertension, which may lead to~     an increase in circulating vWF levels. Indeed, multiple studies have reported that liver~     disease is associated with increased circulating vWF- antigen (vWF-Ag). Furthermore,~     increased circulating vWF -Ag Levels have been shown to be associated with increased~     mortality rates in patients with chronic liver disease. Within a prospective evaluation~     cohort, the investigators were able to document that patients with increased vWF-Ag levels~     prior to liver resection suffered from an increased incidence of postoperative liver~     dysfunction and morbidity. Within this prospective multicenter validation study, the~     investigators now aim to prospectively validate that circulating vWF-Ag prior to liver~     resection is a valuable marker to predict postoperative clinical outcome.~   "
110696|NCT02118532|"~     The purpose of this study is to confirm that the IN.PACT Admiral is safe and effective for~     the interventional treatment of new and non-stented restenotic lesions in the superficial~     femoral artery (SFA) and proximal popliteal artery (PPA) in Chinese patients.~   "
110697|NCT02118519|"~     Induction of autologous repair chondrogenesis to regenerate injured articular cartilage using~     bone marrow mesenchymal stem cells (MSCs) after in vitro expansion under restricted culturing~     conditions.~   "
110698|NCT02118506|"~     The purpose of this study is to compare the effects of mental practice, associated with~     physical practice, on gait (cinematic parameters and mobility) in individuals with idiopathic~     Parkinson's disease. It is believed that familiarity with the normal gait pattern, associated~     with mental practice and physical practice can trigger significant changes in spatiotemporal~     and angular parameters that are not observed in the group not submitted to mental practice.~   "
110700|NCT02118480|"~     The study design was a parallel-group randomized trial with equal randomization. Recruitment~     and enrollment were conducted between June 2012 and January 2013. At base-line, clinical,~     cognitive and functional data was collected. Afterwards, the participants were randomly~     allocated to either the REHACOP group or the Control group. During 3 months the intervention~     with REHACOP program took place and at follow-up patients were again re-evaluated to evaluate~     the changes in clinical, cognitive and functional measures. Post-treatment assessment~     (finished by June 2013) was performed within the first week after completing the~     intervention.Optional enrollment in pre- post neuroimaging will also allow us to look at~     changes in the brain. Finally, longitudinal follow-up at 18 months with neuropsychological~     and neuroimaging assessements was also performed.~      Objective: To examine the efficacy of an integrative cognitive training program (REHACOP) to~     improve cognition, clinical symptoms and functional disability of patients with Parkinson~     disease (PD).~   "
110701|NCT02118467|"~     The investigators hypothesis is that for ICU patients with shock, the use of the vasoactive~     drugs phenylephrine and vasopressin will reduce tachydysrhythmias when compared to~     norepinephrine and epinephrine. To investigate this hypothesis, the investigators are~     conducting a randomized double blind controlled trial comparing phenylephrine and vasopressin~     vs. norepinephrine and epinephrine in ICU patients with shock that is not responsive to IV~     fluids. All patients admitted to the adult intensive care units at the University of Chicago~     will be screened for eligibility.~   "
110702|NCT02118454|"~     The purpose of this study is to test whether twice-daily Interactive Voice Response (IVR)~     calls made at the estimated times of patients' antiretroviral (ART) medication dosing and~     three reminder calls for monthly clinic appointments, will result in improvements in ART~     adherence, appointment attendance, health indicators (CD4 cell counts), coping skills, social~     support, depressive symptoms, and other quality-of-life indicators, compared to a control~     group receiving one IVR assessment call each week, over six months.~      This is a randomized controlled trial of the IVR intervention with n=400 PLH taking first~     line ART in India on a twice-a-day dosing schedule. The research is supported by an Indo-U.S.~     Bilateral review and funding collaboration between NIH and ICMR. The research is being~     implemented in Kolkata by Drs. Smarajit Jana (PI, India) and Protim Ray (Project Director) at~     Durbar, a community-based organization providing HIV/STD prevention and community development~     programs with sex workers and other at-risk communities.~      This is Phase 2 of a two-phase pilot project. Phase 1 was a one-month no-control pilot (n=46)~     for feasibility, acceptability, and patient feedback on preferences for messaging content.~     Phase 2 has two sites, described as Phases 2A and 2b, which will occur simultaneously and~     differ only in their recruitment sites and corresponding sampling strategy (sample size,~     gender ratio, eligibility criteria) based on site population characteristics.~        -  Phase 2A will recruit n=80 women and n=20 men from Durbar's Mamata Care and Treatment~          Center (MCTC) (providing HIV testing and treatment linkage and support) and associated~          Mamata Network of Positive Women (MNPW), which focus on HIV+ sex workers and their male~          partners and networks.~        -  Phase 2B will recruit n=100 women and n=200 men from the ART Centre at the Calcutta~          School of Tropical Medicine (STM), which hosts the largest ART center in the Northeast~          Region of India and has over 3,000 active patients on first line ART.~      The sampling plan reflects the gender distribution of clients and patients at the two sites.~      Participants will be randomized within each site and gender sub-sample to receive:~        -  The IVR Intervention: consisting of two (2) automated voice calls (intervention~          messages) each day for six months, PLUS one IVR assessment call (consisting of four [4]~          questions) every week for 6 months; OR,~        -  The Control Condition: consisting of standard care, PLUS one IVR assessment call~          (consisting of four [4] questions) every week for 6 months.~      All participants will be interviewed in-person by a research team member at baseline and~     followed-up at 2- 4- and 6-months using structured questionnaires and recording information~     from the participant's personal medical record (i.e., their ART Card) to assess background~     characteristics and intervention impacts on ART adherence, health quality-of-life (i.e.,~     depressive symptoms, social support). All participants will receive one IVR assessment phone~     call (consisting of four (4) questions during each week of the 6 month study. Each~     once-a-week IVR assessment will ask about missed medication and the participant's~     health/quality of life, and participants will respond by keying in a 1 (yes) or 2 (no) on~     their mobile phone.~   "
110703|NCT02118441|"~     When a patient undergoes heart surgery, their Anesthesiologist will insert a tiny plastic~     tube, called a catheter, in the artery of the patient's wrist. This is called a radial artery~     catheter. A radial artery catheter allows accurate measurement of the patient's blood~     pressure during surgery. There are two common techniques for placing the radial artery~     catheter. The first is a blind technique whereby the Anesthesiologist feels for the pulse~     in the patient's wrist and places the catheter using the location of the pulse as a guide.~     The second technique, less commonly used, is one whereby the Anesthesiologist uses an~     ultrasound machine (painless to the patient) to see the artery, and thereby uses the~     ultrasound to guide the catheter placement. Our study will test the hypothesis that~     ultrasound-guided radial artery catheterization will have faster insertion times, with fewer~     complications compared with palpation-guided insertion.~   "
110704|NCT02118428|"~     The trial will evaluate the efficacy of the Mirasol Pathogen Reduction Technology for Whole~     Blood to prevent Malaria transmission by transfusion of whole blood.~   "
110705|NCT02118415|"~     Targeted Natural Killer (NK) cell based adoptive immunotherapy for the treatment of patients~     with Non-Small Cell Lung Cancer (NSCLC) after radiochemotherapy (RCT)~   "
110706|NCT02118402|"~     Iron deficiency and anemia are health issues affecting mainly infants and women in developing~     countries. Iron deficiency in infancy can have long-lasting impact on cognitive and motor~     development of the child. Iron fortification has shown to be effective against anemia.~     However, in areas with a high burden of infectious diseases iron may increase the risk of~     unfavorable gut microbiota composition possibly influencing diarrhea prevalence. Therefore we~     want to assess the effects of home fortification of complementary food with two~     iron-containing micronutrient powders (MNPs) with and without the addition of a prebiotic~     (7.5 g of galactooligosaccharides as GOS-75) compared to a control on the composition of the~     gut microbiota of Kenyan infants. In this study we will use an MNP with a moderate iron dose~     of 5 mg, with 2.5 mg of Fe as NaFeEDTA and 2.5 mg of Fe as ferrous fumarate (+Fe). There will~     be 3 study groups MNP, MNP+Fe and MNP+Fe+GOS. The infants will be enrolled in the study at~     the age of 6-10 months and will consume a home-fortified maize porridge for four months. At~     baseline and endpoint (after 4 months of intervention), we will collect blood samples of the~     infants in order to assess anemia, iron status, and inflammation. Fecal samples (from child~     and mother) will be collected at baseline, 3 weeks and at endpoint in order to evaluate the~     changes in gut microbiota and gut inflammation.~      During the intervention, in a sub-group of children who receive broad-spectrum antibiotics,~     we will compare how the three different interventions modify the effect of antibiotics on the~     infant gut microbiota. We will opportunistically select children that are enrolled in the~     study and who become ill, and who are prescribed antibiotics by the local health care team,~     according to the local standard of care in the study area. Five additional stool samples from~     these children will be collected (day 0 (before the first antibiotic dose), 5, 10, 20 and 40)~     to evaluate the changes in the gut microbiota and gut inflammation.~   "
110707|NCT02118389|"~     Effect of Meal Replacement Beverage(Glucerna) on Body Composition,lipid metabolism and blood~     pressure~   "
110708|NCT02118376|"~     GLP-1 receptor agonists promote fat redistribution in obese women with type 2 diabetes,~     reduce liver fat content, improve the inflammation state~   "
110709|NCT02118363|"~     Clinical assessment and monitoring of balance and arm function in stroke patients with sensor~     based measurement, in clinical and home environment.~   "
110710|NCT02118350|"~     The study aimed to evaluate the chronic effects of Mat Pilates Training on blood pressure,~     heart rate, double product and psychobiological factors in hypertensive medicated women and~     acute effects of Mat Pilates Exercise on blood pressure of such individuals.~   "
110711|NCT02118337|"~     To evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination with~     Durvalumab versus Nivolumab Monotherapy in Subjects with Select Advanced Malignancies.~   "
110712|NCT02118324|"~     This is a pilot feasibility study to collect preliminary data for a large-scale exergaming~     intervention in children undergoing maintenance therapy for Acute Lymphoblastic Leukemia~     (ALL). Patients, ages 5-17 years will be randomized to the intervention or non-intervention~     control group. The intervention will consist of 30 minute sessions of exergaming 3-5 times a~     week for 6 months, with weekly assessment of exercise level and phone calls by kinesiology~     graduate students for safety and compliance. Physical activity at baseline and at the end of~     study will be assessed using accelerometers. Outcome measures will include: anthropometrics,~     blood pressure, body composition, visceral fat, vascular function, fasting insulin, fasting~     glucose, LDL-cholesterol, HDL- cholesterol, triglycerides, functional mobility and endurance,~     and strength.~   "
110713|NCT02118311|"~     This is a Simon's optimal two-stage phase II trial designed to estimate grade II-IV acute~     graft-versus-host disease (GVHD) after infusion of T regulatory (nTreg) in a fixed dose ratio~     to the combined CD3+ cell count of the two graft units in recipients of double UCB~     transplantation. The nTreg cells (manufactured from a 3rd cord blood unit) are infused on day~     0 at least 1 hour after the 2nd unit of the double umbilical cord blood (UCB) transplant.~      The nTreg cells require an 18 day (±2 days) lead time based on the planned transplant day.~     The combined CD3+ cell content from the two graft UCB units is enumerated upon thaw (day 0).~     The patient then receives the number of nTregs cells from the 3rd cord product to achieve a~     Treg:CD3+ cells ratio of 5:1. The nTreg cell dose depends on the CD3+ cell content of the two~     graft UCB graft units, but it will not exceed the highest dose level safely tested in the~     ongoing University of Minnesota phase I Treg dose escalation study MT 2006-01.~   "
110714|NCT02118298|"~     The goals of this study are to 1. Investigate the sensitivity of allocentric visual memory~     when compared to more established measures of cognition in identifying cognitive difficulties~     among MS subjects when compared to controls. 2. Determine which cognitive test variable will~     be most strongly associated with self and informant reports of cognition. 3. Determine which~     MRI metric will be most strongly related to neuropsychological test performance 4. Determine~     the degree to which allocentric visual memory is related to functional connectivity on fMRI.~   "
110715|NCT02118285|"~     This is a single center phase I trial designed to determine the maximum tolerated dose (MTD)~     of the oral IDO inhibitor INCB024360 when administered as part of a larger regimen of~     intraperitoneal (IP) delivery of haploidentical donor NK cells and IL-2 after a~     non-myeloablative cyclophosphamide/fludarabine (Cy/Flu) preparative regimen for the treatment~     of recurrent ovarian, fallopian tube, and primary peritoneal cancer.~   "
110716|NCT02118272|"~     The aim of this study is to assess the clinical, radiographic and patient-reported outcome~     measures (PROMs) after total knee replacement with Physica KR, define the survivorship of the~     implants and identify possible risk factors that may lead to failure.~   "
110717|NCT02118259|"~     The main objective of the study is to show that the multidisciplinary review of drug~     prescriptions changes the adverse drug event (ADE) geriatric risk score (according to~     Trivalle and Ducimetière 2013) for patients living in the Nîmes University Hospital Residence~     for Dependent Elderly.~   "
110718|NCT02118246|"~     Patellofemoral Pain Syndrome(PFPS) is one of the most common health-related complaints in~     today's societies. Myofascial pain syndrome(MPS) have been attributed as the main cause and~     primary source of musculoskeletal pain. Trigger point of the vastus lateralis muscle may pull~     the patella superiorly and laterally, increasing compression of the patellofemoral joint~     during physical activities, result in PFPS and anterior knee pain. The purpose of this study~     was to investigate the effects of Dry Needling & kinesio tape on trigger point of vastus~     lateralis muscle in PFPS subjects.~   "
110719|NCT02118233|"~     The purpose of this study is to understand how carotid endarterectomy (CEA) or percutaneous~     carotid angioplasty and stenting (CAS) affect memory and thinking resulting in improving or~     worsening of thinking or memory. There have been many studies on this subject, some finding~     that certain patients gain improvement in their brain function and others might get worse.~     The goal of this study is to discover which patients are more likely to have improved~     cognitive functioning. Carotid endarterectomy (CEA) and percutaneous carotid angioplasty and~     stenting (CAS) are not investigational and are an accepted treatment for your condition. In~     addition, subjects that choose not to undergo surgery will also be included in this study.~   "
110720|NCT02118220|"~     The purpose of this research study is to determine the number of children who have symptoms~     of a concussion at the time they are scheduled for orthopedic surgery at Boston Children's~     Hospital. It is currently unknown if anesthesia affects a child with a previously diagnosed~     concussion. This study is the first phase of a two-part study looking at the effects of~     anesthesia in children undergoing orthopedic surgery with a previous concussion. Currently,~     the decision to continue with surgery in patients with a diagnosed concussion is based on~     clinical judgment by the patients.~   "
110721|NCT02118207|"~     SCUBA diving frequently involves repetitive exposures over multiple days. The goal of this~     study was to see how exercise impacts microparticles (MPs), endothelial function, and venous~     gas emboli (VGE) over a series of dives.~      16 divers in 2 groups each completed 6 dives. One group completed 3 control dives followed by~     5 days rest then 3 dives preceded by exercise. The other group completed the opposite~     protocol. Flow-mediated dilation (FMD) data and blood for MP analysis was collected before~     and after each dive. VGE were monitored via transthoracic echocardiography 30, 60, and 90 min~     after surfacing. Exercise before diving consisted of 60 min running outdoors including 8x4~     min intervals at 90% VO2max effort.~   "
110722|NCT02118194|"~     The overall goal of this project is to determine if non-ambulatory persons with spinal cord~     injury (SCI) who have already participated in at least 20 sessions of ReWalk training can be~     further trained to achieve more advanced skills for use in the home or work place~     environments and outdoor community mobility skills in the ReWalk exoskeleton.~   "
110723|NCT02118181|"~     The purpose of this study is to determine whether a supplementation containing~     β-Hydroxy-β-methylbutyrate is effective in the treatment of age-related muscle loss in a~     group of older women compared to a non interventional group~   "
110724|NCT02118168|"~     An observational study to prospectively follow-up the patients enrolled in the ISS T-002~     clinical trial up to 132 weeks. The primary endpoint of this study is to evaluate the~     persistence, in term of frequency, magnitude and quality, of the anti-Tat humoral and~     cellular immune response in the HIV-1 infected individuals who participated to the ISS T-002~     and who have received at least 3 immunizations. The secondary endpoint is to define and~     validate novel laboratory tests for future efficacy clinical trials.~   "
110725|NCT02118155|"~     The purpose of this study was to evaluate the 6-month outcomes of applying low-intensity~     laser therapy associated with connective tissue grafts to treat gingival recession.~   "
110726|NCT02118142|"~     People with poor insulin sensitivity do not respond normally to elevations in blood sugar.~     This may increase their risk of developing diabetes in the future. The purpose of this~     research study is to determine if the nutrient betaine, found in beets, spinach and wheat~     products, can enhance the production of fetal growth factor 21 (FGF21), a molecule that is~     believed to promote insulin sensitivity.~   "
110727|NCT02118129|"~     The purpose of this study is to examine whether a behavioural intervention changes attitudes,~     knowledge, intake or blood levels of vitamin D in young adults. The hypothesis is that an~     educational component and use of a mobile smartphone 'app' will increase knowledge and/or~     intake of vitamin D.~   "
110740|NCT02117960|"~     The aim of this study is the comparison between the effects of supplementation with omega 3~     or placebo for 8 weeks in serum level of BMP-4, YKL40, HSP70, HSP27 in patients with~     cardiovascular disease.~   "
110939|NCT02115360|"~     A prospective randomized double-blind clinical trial design will be used in a cohort of sixty~     patients of both genders, physical status American Society of Anaesthesiologist (ASA) I and~     II who will undergo lower limb amputation, will be enrolled into the present study. Patients~     will divided randomly into two equal groups: Epidural Bupivacain-Calcitonin and fentanyl (BC)~     Group and Bupivacain- fentanyl (BF) Group, comprising of 30 patients each.~   "
110728|NCT02118116|"~     Gatekeeper training is where people in the community are trained to recognize and identify~     those who are at risk for suicide and assist them in getting care. Gatekeeper training has~     been widely implemented around the world. There are two types of gatekeepers: 1) Designated~     gatekeepers - individuals who have been trained in helping professions (medicine, psychology,~     social work, nursing), and 2) Emergent gatekeepers - individuals who are not in caregiving~     roles (family members, police, teachers, clergy). Applied Suicide Intervention Skills~     Training (ASIST) has been implemented in Manitoba. However, a recent randomized controlled~     trial in First Nations community members (emergent gatekeepers) from the Swampy Cree Tribal~     Council (Northwestern Manitoba) demonstrated that the training had no positive impact on~     self-reported gatekeeper skills or behavior. Also, compared to a resilience retreat, the~     ASIST training was associated with a slightly higher likelihood of reporting suicidal~     ideation. The demonstrated lack of efficacy and the possibility of adverse effects associated~     with this training program in this vulnerable group have raised concerns about the safety and~     efficacy of ASIST. There were several key limitations of the previous study. First, the study~     only recruited community members (emergent gatekeepers), therefore findings may not be~     generalizable to designated gatekeepers (clinicians, nurses, counselors). Second, the study~     had a small sample size (n=55) and may have not been large enough to detect small effects~     that are often associated with educational interventions. Finally, the increase in distress~     in the ASIST trained group may not have been directly related to the training. To overcome~     the above limitations, we aim to conduct a larger evaluation of the safety and effectiveness~     of gatekeeper training that is occurring in Manitoba First Nations, Inuit and Metis~     communities. Based on previous work that suggests designated gatekeepers are more likely to~     benefit from gatekeeper training than emergent gatekeepers, we will examine these groups~     separately.~      Hypotheses: 1) ASIST will be associated with an increase in gatekeeper skills and behaviors;~     2) ASIST will have a stronger impact on designated gatekeepers than emergent gatekeepers; 3)~     ASIST will not be associated with an increase in suicidal ideation or distress.~   "
110729|NCT02118103|"~     The objectives of the proposed research are to quantify the impact on motor performance of a~     single SM intervention on surgical waitlist patients with degenerative Lumbar Spinal Stenosis~     (LSS) using a recently established lower extremity movement task: 1) using alterable levels~     of task difficulty that is resistant to learning and 2) using measurement of movement~     kinematics.~   "
110730|NCT02118090|"~     The investigators propose to leverage the unique infrastructures and expertise of National~     Centre for Parasitology Entomology and Malaria Control and the Pasteur Institute in Cambodia~     and combine modern fieldwork, including a mobile laboratory fully equipped for molecular~     biology and culture experiments, with state-of-the-art genomic analyses to investigate how~     Plasmodium vivax parasites respond to antimalarial drugs. The investigators will focus on~     resistance to CQ, the choice treatment for vivax malaria in most endemic countries, for which~     treatment failures have been reported in Cambodia. The study will address some of the key~     biological mechanisms limiting the efficiency of drug therapy in P. vivax, including the~     identification of genetic polymorphisms underlying drug resistance in Cambodian P. vivax. The~     findings will provide a first unbiased perspective on the mechanisms of drug resistance in P.~     vivax and have the strong potential to significantly improve malaria control in Southeast~     Asia.~   "
110731|NCT02118077|"~     Compare the effect of G17DT with that of placebo on the survival of subjects with advanced~     pancreatic cancer.~   "
110732|NCT02118064|"~     This study was designed to evaluate the ability for G17DT to slow or arrest tumor growth in~     patients with refractory colon cancer who had been previously treated with an~     Irinotecan-based chemotherapy.~   "
110733|NCT02118051|"~     Patients who have had or are expected to have a poor ovarian response (POR), because they~     meet any of the criteria of Bologna, can benefit from ovarian stimulation with 150 mg of~     alpha Corifollitropin (CFA) (Elonva ®) as single dose for a week, in the cycles of in vitro~     fertilization (IVF).~      In this study aims to demonstrate non-inferiority of the Corifollitropin Alpha (CFA ) versus~     daily administration of Human Menopausal Gonadotropin (hMG) (Menopur ®) during the first~     seven days of ovarian stimulation, in a protocol with gonadotropin-releasing hormone ( GnRH)~     antagonists~   "
110734|NCT02118038|"~     To assess the impact and to identify the main risk factors for psychological and cardiac~     morbidity (post-traumatic stress disorder, anxiety and depression) in case of postpartum~     hemorrhage~   "
110735|NCT02118025|"~     The investigators aimed to evaluate the clinical results and the inflammatory response of the~     minimal extracorporeal circulation system (MECC) Compared with off-pump coronary~     revascularization (OPCABG).~      This is a randomized and prospective study in 230 patients with indications for coronary~     surgery, with 113 patients in the OPCABG group and 117 in the MECC group. The endpoints were~     the clinical and biochemical results, intra-operative outcomes and the determination of 19~     inflammatory circulating markers, 17 of them for the first time analyzed comparing both~     techniques.~   "
110736|NCT02118012|"~     Background:~      - Hepatitis C is a liver disease caused by the hepatitis C virus. It is the most common cause~     of serious liver disease in the United States. Many people have few if any symptoms. It can~     lead to cirrhosis, which can cause liver failure and cancer. Researchers want to study how a~     medicine called chlorcyclizine works in patients with hepatitis C. They want to see if it can~     be used to treat hepatitis C alone or when used with the standard hepatitis C treatment drug~     ribavirin.~      Objectives:~      - To see if chlorcyclizine can be used to treat hepatitis C alone or in combination with the~     drug ribavirin.~      Eligibility:~      - Adults with chronic hepatitis C who either have never been treated for it or have relapsed~     after prior treatment.~      Design:~        -  Participants will be screened with medical history, physical exam, blood and urine~          tests, and a questionnaire. They will also have an ultrasound of their abdomen and~          electrocardiogram. Some of these tests will be repeated throughout the study.~        -  Participants will spend 3 days as an inpatient to be monitored while starting study~          drug. They will be assigned randomly to a group and will begin taking the study drug.~          Blood will be taken frequently.~        -  Group I will take the study drug twice a day for 28 days.~        -  Group II will take the study drug twice a day and ribavirin twice a day for 28 days.~        -  Participants will visit the clinic every 7 days for 28 days.~        -  After participants stop taking the study drug, they will have 5 follow-up visits over 3~          months.~   "
110737|NCT02117999|"~     The purpose of the present Randomized Clinical Trial (RCT) is to compare the efficacy and~     safety of transepithelial corneal cross-linking using iontophoresis (T-ionto CL) to treat~     progressive keratoconus in comparison with standard cross-linking (standard CL).~   "
110738|NCT02117986|"~     The study hypothesis is that the loading dose of intravenous colistin (6 million of~     international units) is associated with greater clinical and microbiological efficacy, and~     reduced mortality of critically ill patients infected by multidrug resistant Gram- negative~     bacilli, compared to a scheme without loading dose.~   "
110739|NCT02117973|"~     The purpose of this prospective randomized study is to evaluate iAssist with respect to~     radiographic, clinical and economic outcomes in comparison to conventional instrumentation in~     primary total knee arthroplasty using the Persona knee system among patients with BMI>=30.~   "
110741|NCT02117947|"~     The goal of this study is to reduce infant and toddlers' secondhand smoke exposure (SHSe) in~     a high risk, medically underserved population of maternal smokers. The program is called~     Philadelphia FRESH (Family Rules for Establishing Smokefree Homes). Participants are~     recruited from low-income urban neighborhoods in Philadelphia, Pennsylvania. After~     determining study eligibility via telephone screen, all participants complete an in-home~     pre-intervention interview that includes self-reported smoking history, current smoking and~     exposure patterns, and factors that relate to maternal smoking (such as depressive symptoms,~     weight concerns, nicotine dependence,) as well as collection of child urine cotinine (a~     biomarker used to detect SHSe).~      Participants are randomized after baseline to receive either (a) a moderately intensive (up~     to 2 in-home sessions, 8 phone sessions) Behavioral Counseling intervention (BC) delivered~     over a 16-week period by counselors trained and supervised by investigators, or (b) an~     enhanced Self-Help Control (SHC) that uses brief advice and a detailed self-help manual for~     SHSe-reduction and smokingcessation. Post intervention assessments include self-reports of~     intervention process, factors associated with intervention effects, and intervention outcomes~     that include child urine cotinine (to measure level of SHSe) and participant saliva cotinine~     (to verify self-reported smoking quit status). Interviewers and data management staff remain~     blind to the treatment assignment. All procedures are implemented after signed informed~     consent and were approved by Temple University's Institutional Review Board.~   "
110742|NCT02117934|"~     The purpose of the study is to evaluate the safety and immunogenicity of an investigational~     hepatitis B vaccine (HEPLISAV) in adults 18 to 70 years of age.~   "
110743|NCT02117921|"~     To determine if Mind Body Syndrome (MBS) therapy will reduce or eliminate pain in patients~     suffering from chronic pain syndromes without organic etiology.~   "
110744|NCT02117908|"~     The project aims to study whether the application of a continuous positive airway pressure~     (CPAP) of 4 cm water vapor is a safe method in pulmonary radiofrequency intervention (PRF)~     lung cancer under conscious sedation compared with placebo. And, assess whether CPAP prevents~     atelectasis formation and consequently reduces the potential complications of PRF and~     improves procedural success~   "
110745|NCT02117895|"~     This is a prospective study of left celiac plexus resection for pancreatic cancer at the body~     and tail during standard distal pancreatectomy.~   "
110746|NCT02117882|"~     It is assumed that the minimally invasive lateral approach and the traditional lateral sinus~     lift procedure will result in better outcomes in terms of height of augmented bone.~      It is also assumed that the minimally invasive lateral approach will reduce surgical~     complications and patient's discomfort in comparison with a traditional lateral sinus lift~     procedure.~   "
110747|NCT02117869|"~     Grapefruit (GF) contains furanocoumarin (FC) which is known to irreversibly inhibit the~     activity of cytochrome P450-3A (CYP3A) enzymes in the human gastrointestinal tract (PAINE~     2005). Because CYP3A enzymes are integral in the metabolism of some drugs, co-ingesting GF or~     GF Juice (GFJ), which inhibits CYP3A, along with drugs reliant on CYP3A for metabolism can~     significantly alter the drugs kinetic properties and result in elevated plasma drug~     concentrations which may be toxic. The Citrus Research and Education Center at the University~     of Florida has developed a new GF hybrid (GFH) which contains low FC content and which may~     not inhibit CYP3A enzyme activity, and therefore may be safe to co-ingest with drugs that~     require CYP3A activity for metabolism. The investigators hypothesize that low FC GFHJ will~     not inhibit CYP3A to the degree that regular GFJ does, and will not significantly affect~     midazolam kinetics compared with regular GFJ. Midazolam is an FDA approved probe drug for~     CYP3A activity and has been used previously to establish an interaction between GFJ and~     midazolam. This study will evaluate the concomitant administration of midazolam and low FC~     GFHJ, regular GFJ, or water to evaluate the significance of this interaction.~   "
110748|NCT02117856|"~     This study is a randomized clinical trial to compare patient satisfaction and prosthetic~     outcomes with lower dentures retained by one or two implants. The investigators long-term~     objective is to establish evidence of the cost-effectiveness of a single implant intervention~     for improving tolerance to complete dentures. The investigators MAIN AIM will be to~     investigate patient satisfaction between and within groups with mandibular dentures retained~     by one or two implants over five years, and SECONDARILY to investigate the survival of~     implants, and the frequency of events to maintain the dentures and prosthetic attachments as~     clinically serviceable. Furthermore, multivariate analysis can assess the prediction of~     patient satisfaction with implant dentures based on various possible factors including age,~     health, demography and socioeconomic status, number of implants, and maintenance needs.~     Patient satisfaction will be measured by means of Visual Analogue Scales (VAS) including a~     measure of overall satisfaction and various specific aspects of satisfaction such as~     appearance, stability and comfort of the dentures.~      The CENTRAL HYPOTHESIS is that mandibular complete dentures retained by single implants are~     at least as satisfying to patients over a five years period as those retained by two implants~     for the same period.~      The SECONDARY HYPOTHESES are that:~      i) there is no difference over five years between groups in the survival of original~     implants, or in the number of events for maintenance of the dentures or implant attachments;~     and ii) using each treatment group as it's own control, there is no change in patient~     satisfaction with lower dentures retained by either one or two implants during the five year~     loading period.~   "
110749|NCT02117843|"~     The study is a Prospective, Multi-center, Single Armed Registry to Evaluate The Safety and~     Efficacy of 'AVI' Stent for Treating Coronary Revascularization.~   "
110750|NCT02117830|"~     This is a Phase I, single-site, randomized, double-blinded, double-dummy, placebo- and~     positive-controlled, 4-period crossover study to evaluate the effect of two dose levels of~     Androxal on cardiac repolarization. Baseline ECGs will be obtained prior to dosing in each~     Period and ECGs will be obtained during expected peak plasma concentrations of Androxal and~     the positive control.~      In each Treatment Period subjects will be admitted to a Clinical Research Unit where study~     drug will be administered as three (3) daily single doses. Treatment Periods will be~     separated by a washout of at least 7 days between Periods.~   "
110964|NCT02115035|"~     The objective is to evaluate the overall response rate of Vermurafenib when administered~     orally to patients with relapsed or refractory multiple myeloma.~   "
145017|NCT01669200|"~     The primary aim of this study is to assess whether daily dosing with medium chain~     triglycerides in subjects with mild cognitive impairment (MCI) will improve cognitive~     performance.~   "
110751|NCT02117817|"~     The purpose of the first part of this study or the dose escalation portion of the study is to~     determine what dose of BKM120 and Abraxane is safe to give when the two drugs are used at the~     same time in patients who are diagnosed with a solid cancer. A solid cancer is a cancer that~     does not involve the blood, bone marrow or lymph nodes. Dose escalation determines the least~     toxic and most effect dose of this drug combination for treatment. Once this dose is~     established, it will be used for the dose expansion phase of the study where we will~     determine the effect of BKM120 and Abraxane in women diagnosed with a recurrent endometrial~     or ovarian cancer. We will see whether the combination of both drugs improves the response~     and survival of patients treated on the two drug regimen. Also we will try to find out~     whether there are changes in tumors that can help us determine what patients are more likely~     to respond to BKM120 and Abraxane.~   "
110752|NCT02117804|"~     The purpose of this study is to determine the predictive performance of the Early Screen for~     Discharge Planning (ESDP) tool in a regional community hospital. The central hypothesis is~     that the ESDP differentiates between patients in a regional community hospital who would~     benefit from those who would not benefit from early discharge-planning intervention as~     measured by problems and unmet continuing care needs, quality of life, length of stay, and~     referrals to post-acute services.~   "
110753|NCT02117791|"~     This local, prospective, non-interventional, multi-center study includes patients treated~     with Riociguat for inoperable CTEPH(Chronic thromboembolic pulmonary hypertension)/~     persistent or recurrent CTEPH after surgical treatment. It is planned to include a total of~     400 patients (valid for safety analysis). This study is performed as an all-case~     investigation. The treatment of Riociguat is performed based on the product label in Japan.~     The standard observation period is 12 months from the 1st treatment of Riociguat. Safety and~     effectiveness are evaluated at 4th and 12th month. In addition, the extension observation is~     carried out once a year for 7 years at the longest to collect information on safety and~     effectiveness as long as Riociguat treatment continues. When the treatment of Riociguat is~     terminated, observation of a patient ends. For each patient, the investigator records data as~     defined in the protocol at each evaluation point by using the Electronic Data Capture (EDC)~     system. The duration of the study is approximately 9 years from launch.~   "
110754|NCT02117778|"~     This study is designed to evaluate lung function and pain control of continuous~     supraclavicular versus suprascapular versus interscalene nerve catheters in subjects~     undergoing total shoulder replacement. The investigators hypothesize that all three groups~     would have similar pain control; the supraclavicular and suprascapular groups may have better~     lung function.~   "
110755|NCT02117765|"~     In type 1 diabetes (T1D), immune defense cells in the body attack and destroy~     insulin-producing beta cells leaving affected people with a lifelong need for daily insulin~     injections. Even with insulin injections, blood glucose (sugar) control is imperfect and~     leads to many health complications and a shortened life span. This is a pilot clinical trial~     to test the safety of a drug, ustekinumab, in 20 adult subjects with recent-onset T1D.~     Ustekinumab is currently licensed for use in psoriasis where it has proven to be both highly~     effective and safe and so the investigators hope to see a similar effect in T1D. This trial~     will also be used to determine the best dosage and frequency of the drug to be given to~     people with T1D to help design future studies on the drug's effectiveness. The investigators~     hope that if the drug can block immune cells soon after the development of diabetes, any~     remaining insulin-producing cells may be protected, and regenerate, thus producing more~     insulin so that individuals may be insulin free, or require less insulin.~   "
110756|NCT02117752|"~     This study will determine the cumulative irritation potential and sensitization potential of~     dapsone gel and vehicle after repeat applications on the skin of healthy volunteers.~   "
110757|NCT02117739|"~     This study will evaluate the potential of dapsone gel and its vehicle to cause a~     photoallergic reaction after repeated application and irradiation to the skin of healthy~     volunteers under controlled conditions.~   "
110758|NCT02117726|"~     Sedation drugs that are commonly used in ICU in treatment of ARDS, includes propofol,~     midazolam and dexmedetomidine . Among these, both dexmedetomidine and propofol have been~     reported to be used together with midazolam in ICU and the combination of propofol and~     midazolam is most commonly used, but things follow include a high incidence rate of delirium,~     But the combination of midazolam and dexmedetomidine may have complementary advantages and~     could have be a better choice for sedation. In this study, we attempted to observe the~     effects of two different drug regimens on delirium incidence rates in severe ARDS patients' :~     midazolam and propofol vs propofol and dexmedetomidine .~   "
110759|NCT02117713|"~     This is a multicentre, extension study of LUM001 in children diagnosed with Alagille Syndrome~     who have completed participation in a core LUM001 treatment protocol. The primary objective~     is to evaluate long-term safety and tolerability of LUM001. Efficacy will be assessed by~     evaluating the effect of LUM001 on the biochemical markers and pruritus associated with~     Alagille Syndrome.~   "
110760|NCT02117700|"~     Although weight reduction through physical activity-based interventions is the mainstay~     therapy for nonalcoholic fatty liver disease (NAFLD), its maintenance is difficult and~     typically unsuccessful. This affirms the extreme need for alternate and/or adjunct therapies.~     Although convincing data from animal studies and a few adult human studies on the benefits of~     a natural product, N-acetyl cysteine (NAC), in a variety of liver conditions including NAFLD~     have emerged, studies in children are scarce. Therefore, the aim of the study is to test the~     use NAC as an innovative approach to attenuate the progression of NAFD in obese children with~     biopsy proven NASH. The central hypothesis is that NAC supplementation will reduce liver fat~     and liver enzymes and ameliorate risk factors of cardiometabolic disease in children with~     NAFLD.~   "
110761|NCT02117687|"~     This study will evaluate the safety and efficacy of OPTIVE FUSION™ compared to VISMED® Multi~     for the management of dry eye.~   "
110762|NCT02117674|"~     The aim of this study is to evaluate FUSE-colonoscopy in terms of feasibility and its~     possible additive contribution in the detection of important lesions, namely polyps and~     cancers, compared to the standard forward-viewing approach, with and without the addition~     of the right-colon retroflexion technique, in a series of patients undergoing back-to-back~     screening or surveillance colonoscopies in a randomized fashion.~   "
110763|NCT02117661|"~     Obesity is one of the main causes of the metabolic syndrome, a condition which is becoming~     more common in Canada and worldwide. Metabolic syndrome is a name for a group of heart~     disease risk factors that occur together: obesity, diabetes, high blood pressure, and high~     cholesterol. These patients have a high risk of developing narrowing and blockages of blood~     vessels which occur when fat and cholesterol build up in the walls of blood vessels and form~     plaque. This is called atherosclerosis. Plaque buildup leads to stroke, heart attacks, and~     death. We do not understand the underlying mechanisms of the metabolic syndrome and we do not~     have a treatment for it. L-carnitine, a dietary supplement, has been shown to treat some~     components of the metabolic syndrome, but its benefit to reduce plaque in the blood vessels~     has never been studied. Recently there has been some controversy because a new study showed~     that L-carnitine could make heart disease worse in some patients. Our goal is to study~     whether supplementation with L-carnitine does in fact prevent or reduce buildup of plaque in~     blood vessels of patients with the metabolic syndrome. This novel therapy has the potential~     to decrease the burden of heart disease in obese and diabetic patients with the metabolic~     syndrome.~   "
110764|NCT02117648|"~     The purpose of this study is to assess how the body handles LY2835219 when it is given with~     another drug called clarithromycin. The study doctor will measure the amount of LY2835219~     that is absorbed into the blood stream and the time that it takes to remove LY2835219 from~     the body. The safety and tolerability of these drugs will be studied.~      Each participant will complete 2 study periods in fixed order. After screening, Period 1 will~     last approximately 8 days and Period 2 will last approximately 15 days. Participants who~     complete Period 2 may continue to receive LY2835219 in 28-day cycles until discontinuation~     criteria are met.~   "
110765|NCT02117635|"~     The primary aim of this Phase II trial is to determine whether it is sufficiently likely that~     CTX DP treatment at a dose level of 20 million cells improves the recovery in the use of the~     paretic arm in acute stroke patients to justify a subsequent larger prospectively controlled~     study.~      This study will evaluate the safety and efficacy of intracerebral CTX DP at a dose level of~     20 million cells in patients with paresis of an arm following an ischaemic middle cerebral~     artery (MCA) stoke. Eligible patients will have no useful function of the paretic arm a~     minimum of 28 days after the ischaemic stroke (a modified NIH Stroke Scale (NIHSS) Motor Arm~     Score of 2, 3 or 4 for the affected arm).~   "
110766|NCT02117622|"~     This study is conducted in Asia. The aim of the study is to evaluate long term safety and~     efficacy of Tresiba® (insulin degludec) in patients with diabetes mellitus in routine~     clinical practice in India.~   "
110767|NCT02117609|"~     The objective of this study is to determine whether a supplementation with a new high-protein~     oral supplement can improve the evolution of functional parameters in elderly patients in~     nursing homes.~   "
110768|NCT02117596|"~     Damage and scarring of a transplanted kidney has become the most common cause of loss of the~     transplanted kidney. This kidney damage is a complex process caused by many factors including~     injury during obtaining and transplanting the kidney, injury from the immune system, injury~     from infections, and injury from drugs used to stop rejection. This injury leads to scars~     that decrease the kidney's ability to function properly, and over time the kidney is lost.~     Prograf® (tacrolimus) has been one of the main drugs used to prevent rejection. However, when~     used over time it has been shown to cause chronic damage and scarring in the transplanted~     kidney.~      The purpose of this experimental study is to determine whether children can safely be~     withdrawn from Prograf® after transplantation and changed to Rapamycin® (sirolimus). Recent~     research studies in adult transplantation have demonstrated that with the use of Rapamycin®~     (sirolimus), it is possible to discontinue the use of Prograf (tacrolimus) with no increase~     in rejection, with decreased scarring in the kidney, and with improvements in kidney function~     and survival of the kidney. A total of 50 children will enroll in this study at university~     centers around the country. This study will last about 3 years.~   "
110769|NCT02117583|"~     To estimate the effect of food on the pharmacokinetics and relative bioavailability of~     oxycodone following oral administration of single 40 mg doses of PF 00345439 Formulation K~     taken whole or after chewing in healthy volunteers. We have described below the two cohorts~     each with two arms in this crossover study by listing them as four Arms/Groups in order to~     capture the differences between the cohorts prior to the crossover and after the crossover.~     14 participants are planned for the first cohort and 18 participants are planned for the~     second cohort.~   "
110770|NCT02117570|"~     This study will investigate a Clostridium difficile vaccine in healthy adults aged 50 to 85~     years, who will each receive 3 doses of vaccine. The study will assess the safety and~     tolerability of the vaccine, and also look at the subjects' immune response to the vaccine.~   "
110771|NCT02117557|"~     -  Compared with traditional open colectomy, laparoscopic surgery is associated with less~          pain, earlier recovery, and better cosmetic outcome, and its short- and long-term~          oncologic outcomes have been demonstrated.~        -  In experienced surgeons' hands, single incision laparoscopic surgery is increasingly~          performed for colorectal disease, and even for malignant lesion because of its reduced~          incision-associated morbidity and scarring.~        -  However, the safety and efficacy of single incision laparoscopic surgery for colorectal~          cancer has not yet been evaluated. Thus, the prospective randomized trial comparing~          single incision versus conventional laparoscopic surgery for colorectal cancer is~          needed.~   "
110772|NCT02117544|"~     The purpose of this study is to evaluate the visual performance of a new multifocal High ADD~     contact lens compared to the currently-marketed AIR OPTIX® AQUA MULTIFOCAL (AOAMF) High ADD~     Contact Lens.~   "
110798|NCT02117193|"~     Although the effects of acute alcohol intake and sleep deprivation on exercise performance~     lacks evidence in the literature, in many situations, they occur simultaneously. Once the~     alcohol affects physiological processes, the processes that occur during sleep can be~     impaired, such as: suppression of GH release, action of neurotransmitters and neuromodulators~     in the CNS, changes in the proportion of sleep stages and may lead to suppression of REM~     sleep. These changes promote a significant functional impairment such as a reduction in~     alertness and modification in reaction time, which affects the performance of any activity of~     daily and professional life. However, the combined effects on the physical performance~     variables, such as aerobic and neuromuscular performance lack of evidence in the literature.~   "
110773|NCT02117518|"~     It is well established that CD8 and CD4 T cells reactive against defined islet antigens are~     associated with initiation and progression of Type 1 Diabetes (T1D). In previous work, we~     have demonstrated that it is possible to redirect T cells against pathogenic T cells via~     chimeric peptide/MHC/CD3-zeta receptors in a peptide-specific manner and to prevent, or~     inhibit diabetes in NOD mice. In this study we intend to extend this approach to T cells of~     T1D patients. Working hypothesis: Beta cell-reactive CD8 T cells of human T1D patients can be~     immuno-targeted by their own gene-modified cytotoxic T lymphocytes (CTLs). Aims: Our major~     aim is to demonstrate, in a set of ex-vivo experiments, such immunotargeting with T cells~     derived from T1D patients at the Ziv Medical Center. To this end we will stimulate and expand~     autoreactive CD8 cells in blood samples of T1D patients and target them, ex-vivo, with~     genetically-reprogrammed CTLs which are present in the same blood samples.~   "
110774|NCT02117505|"~     The purpose of this study is to evaluate the relative bioavailability (the extent to which a~     drug or other substance becomes available to the body) of JNJ-54781532 formulation 2 (test)~     compared with JNJ-54781532 formulation 1 (reference) in healthy participants under fed~     conditions at a single dose of 150 milligram (mg).~   "
110775|NCT02117492|"~     The purpose of this study is to evaluate the possible impacts of two techniques of vaginal~     cuff closure during robotic hysterectomy. We aim to compare vertical vs horizontal vaginal~     cuff closure and the impact that these techniques have on vaginal length, sexual function,~     and overall complication rates.~   "
110776|NCT02117479|"~     Determining the efficacy, based upon overall survival, of ruxolitinib added to capecitabine~     for the treatment of advanced or metastatic pancreatic cancer.~   "
110777|NCT02117466|"~     In this study the investigators will evaluate the uptake of 89Zirconium labeled cetuximab in~     extra-hepatic colorectal metastases. The investigators hypothesize that uptake of~     89Zr-cetuximab is required for response to cetuximab. If no uptake is present the~     investigators will escalate the dose cetuximab and repeat the 89Zr-cetuximab PET.~      The investigators will evaluate the clinical benefit rate of cetuximab in the patients with~     and without uptake. The ultimate goal is to create a selection tool that can predict response~     of cetuximab.~   "
110778|NCT02117453|"~     The purpose of this study is to assess whether rosuvastatin could reduce the subclinical~     markers of atherosclerosis and the incidence of major cardiovascular events in patients with~     primary necrotizing vasculitides.~   "
110779|NCT02117440|"~     This study is designed to apply various scans such as functional imaging,~     Fluorodeoxyglucose_Positron Emission Tomography (FDG-PET), 62Cu-ETS (Copper) PET,~     Ventilation/Perfusion Single Photon Emission Computerized Tomography (V/Q SPECT), cardiac~     magnetic resonance imaging (MRI), Tc-99m HMPAO SPECT/CT, and pulmonary function tests before,~     during and after treatment to see if it predicts how well the treatment works for your cancer~     and how well your lungs function during treatment. A Computerized Tomography (CT) will also~     be performed along with both of these procedures to help the researchers see clearly where~     your cancer or your healthy lung is located. The researchers also perform blood tests in this~     study to look for markers in your blood to see if it helps them determine your risk of~     developing side effects from radiation to the lungs. They will also measure your~     health-related quality of life before, during and after treatment. The researchers hope that~     this study will help them in the future to design radiation treatment plans that provide the~     best treatment for each individual patient.~   "
110780|NCT02117427|"~     The objectives of this study are to assess safety and to evaluate the biologic activity of~     TARGTEPO treatment.~   "
110781|NCT02117414|"~     The purpose of the Evera MRI™ study is to confirm safety and efficacy of the Evera MRI ICD~     (Implantable cardioverter-defibrillator) System in the clinical MRI (Magnetic Resonance~     Imaging) environment when subjects receive MRI scans without positioning restrictions (MRI~     scans may occur anywhere on the body).~   "
110782|NCT02117401|"~     To evaluate the effect and safety of mivacurium chloride in pediatric patients.~   "
110783|NCT02117388|"~     The purpose of this study is to evaluate the relative efficacy and effectiveness of specific~     components of cognitive behavioral therapies for insomnia: sleep restriction (SR) and~     cognitive therapy (CT) in comparison to combined SR and CT (SR+CT).~   "
110784|NCT02117375|"~     The purpose of this study is to evaluate the prognostic value of early focal lesions and~     early diffuse lesions on ambulatory disability progression within 5 years after clinical~     onset.~   "
110785|NCT02117362|"~     The goal of this study is to determine a safe dose of GR-MD-02 used in combination with the~     FDA-approved dose of ipilimumab (3 mg/kg) in patients who have advanced melanoma. GR-MD-02 is~     a galectin. Galectins are a family of proteins that have numerous functions in normal~     mammalian biology including the facilitation of cell-cell interactions, regulation of~     cell-death and regulation of immune system responses. The hypothesis is that a safe dose of~     GR-MD-02 when given with the FDA-approved dose of ipilimumab can be found.~   "
110786|NCT02117349|"~     The purpose of the study is to show that Raplixa plus gelatin sponge is better than gelatin~     sponge alone in stopping mild to moderate bleeding in children having surgery~   "
110787|NCT02117336|"~     This is an open-label, Phase I/Ib trial with a dose escalation phase, followed by a dose~     extension phase. The objective of the dose escalation phase is to evaluate the~     pharmacokinetics (PK) and MTD of P1446A-05 in relapsed/refractory CLL and the objective of~     the dose extension phase is to evaluate the safety, efficacy and pharmacodynamics of~     P1446A-05 in 14 patients at the MTD level.~   "
110799|NCT02117180|"~     This pilot study aims to establish whether a low FODMAP diet is safe in children with~     functional gastrointestinal disorders. The practicality of implementing this diet will be~     evaluated as well as symptom improvement and quality of life. A larger intervention trial, if~     deemed appropriate, will then follow to assess symptom efficacy in children.~   "
110800|NCT02117167|"~     Open label multicentric randomized phase II trial, using high throughput genome analysis as a~     therapeutic decision tool, aimed at comparing a targeted treatment administered according to~     the identified molecular anomalies of the tumor with a standard treatment (pemetrexed in~     Non-squamous patients and erlotinib in squamous cells, targeted substudy 1) as well as~     immunotherapy with maintenance therapy in patients without actionable genomic alterations or~     non eligible to substudy 1 (immune substudy 2).~   "
110788|NCT02117323|"~     A prospective observational study on corneal opacities in infants and children (1 month to 18~     years old) will be conducted at CHLA. Most of these cases will be due to congenital corneal~     opacity (e.g. Peter's anomaly, mucopolysacharidoses) or scarring due to infectious keratitis.~     Sixty (60) subjects will be recruited. The children will be examined under anesthesia with a~     portable slit-lamp and OCT. An iVue OCT system (Optovue) attached to an operating~     microscope-style mount at CHLA will be used for the intraoperative scans. Both~     cross-sectional and 3-D OCT scans will be performed to assess opacity depth, pachymetry map,~     endothelial defects, and any abnormal adhesion between the cornea, iris and lens. The~     anterior chamber angle will also be imaged with cross-sectional OCT to assess angle depth,~     trabecular meshwork, Schwalbe's line, and possible peripheral iridocorneal adhesion or~     posterior embryotoxon. OCT of the crystalline lens will be obtained to assess the presence of~     cataract. Slit-lamp photography will be obtained, and gonioscopy will be performed if~     indicated. Corneal diameter will be measured with a caliper, and intraocular pressure will be~     measured with a tonopen (Reichert).~   "
110789|NCT02117310|"~     This is a feasibility study in which indocyanine green (ICG) will be administered during~     routine expanded endonasal approach (EEA) for cranial base pathologies in which a nasoseptal~     flap harvest will be necessary. The research entails administering ICG, which is already~     widely used during open neurosurgical procedures, to identify the blood supply at two~     distinct stages of endonasal cranial base surgery: during nasoseptal flap harvest and after~     final positioning of the nasoseptal flap to ensure its viability before ending the case.~   "
110790|NCT02117297|"~     Allogeneic stem cell transplantation followed by targeted immune therapy with Gemtuzumab~     Ozogamicin (Mylotarg) will be given to patients with average risk AML or MDS.~   "
110791|NCT02117284|"~     Rubidium is a newly approved nuclear medicine imaging drug or 'tracer' used to look at blood~     flow in the heart. This tracer is given using a special pump called an 'elution system' which~     is considered investigational. This means the device is not yet approved by Health Canada for~     general use, but it has been approved for use in this study. It has been used routinely in~     this hospital since 2010.~      The purpose of this study is to confirm proper operation of the pump. It may also help~     identify areas for future improvement. The study data may be used for safety reporting to the~     Ministry of Health or to Health Canada. The study will enroll 2,400 patients in 6 hospitals~     across Canada. The University of Ottawa Heart Institute (UOHI) will enroll up to 1,200~     patients.~   "
110792|NCT02117271|"~     The investigators hypothesized that the treatment of obstructive sleep apnea (OSA) with~     continuous positive airway pressure (CPAP) will positively affect the appearance of the~     patient. The purpose of this study was to compare effects of one month of treatment of CPAP~     and placebo on appearance of patient with OSA in a randomized and crossover study.~      Consecutive sleepy patients with severe OSA were included. The patients underwent three~     polysomnograms (PSG): first one to confirm OSA and two additional ones using placebo (nasal~     dilator) and for CPAP titration before starting each treatment period. All patients were~     randomly included into two treatment groups: 1) placebo use and 2) CPAP use. After one month~     with the first treatment and 15 days of washout, patients were crossed-over for the second~     treatment. Photographs from the patients' faces were obtained in the three experimental~     moments. The photographs were presented in a random order by the Qualtrics Survey Software,~     and were evaluated online by 704 observers for quantifying healthy appearance (unhealthy to~     extremely healthy), attractive (unattractive to extremely attractive) and tired (not tired to~     extremely tired). Apparent age was also rated for each observer. Quantitative evaluations of~     the skin characteristics of the patients' faces were also carried out at each experimental~     moment, including the presence of acne, patches, porosity, wrinkles, texture, and skin tone~     uniformity, through the capture of images by VISIATM System equipment.~      During treatment period, the 30 patients (age = 46±9 years, 21 men) wearing placebo~     intervention on 98% of the nights and adherence to CPAP was 94%, with a mean of 6.0 ± 1.7~     hours of use per day of treatment. Observational assessment of the photographs showed that~     patients were evaluated as being younger after using CPAP (P <0.001), but no quantitative~     changes in face skin characteristics were observed compared to the baseline and after the use~     of placebo.~      Sleepy patients with severe OSA had a younger appearance after one month of CPAP treatment.~   "
110793|NCT02117258|"~     The primary objective of this study is to compare the efficacy of GEM plus Z-360 versus GEM~     plus placebo on the overall survival (OS) in subjects with metastatic Pancreatic~     Adenocarcinoma.~   "
110794|NCT02117245|"~     The objective of this study is to assess the bioavailability of the MGCD265 formulation~     following oral administration under fed conditions (Treatment-1) as compared to fasting~     conditions (Treatment-2) in healthy male and female volunteers.~   "
110795|NCT02117232|"~     Colonoscopy has become the gold standard in detection of colonic polyps and colon cancer.~     However, colonoscopy causes significant abdominal discomfort and abdominal pain during and~     after the procedure, requiring intravenous sedation and use of analgesics. The discomfort and~     pain are mostly caused by air insufflation and intubation difficulties during advancement of~     the colonoscope in order the reach the cecum.~      Study Hypothesis: Use of the Visualization Balloon will facilitate advancement of the~     colonoscope and will eliminate the need for colonic distention with the air or CO2, which can~     shortened the length of the procedure, reduce patient's discomfort and can decrease amount of~     sedatives and analgesics used during colonoscopy.~   "
110796|NCT02117219|"~     This is a multicenter, open-label, Phase 1 study to assess the safety and antitumor activity~     of MEDI4736 as Monotherapy or in Combination with Tremelimumab with or without Azacitidine in~     Subjects with myelodysplastic syndrome after treatment with hypomethylating agents~   "
110797|NCT02117206|"~     The symptoms and severity of arterial disease is secondary to perfusion deficit. The specific~     alteration of the mitochondrial function of ischemic skeletal muscle plays an important role,~     and therapeutic enhancing mitochondrial function are associated with a clinical improvement~     with increase in the walking distance of the patient.~      In severe ischemia, reperfusion required is accompanied by a deleterious episode through a~     worsening of endothelial dysfunction (impaired pathway of nitric oxide (NO)), majorant~     alteration of cellular energy and the hormonal and inflammatory responses. This is~     reperfusion syndrome, which can lead to grave consequences. Our goal is to limit~     mitochondrial and endothelial dysfunction (increased by the reperfusion) by stimulating the~     NO pathway by in situ addition of its precursor, L-arginine. Our working hypothesis is that~     this cellular improvement will be accompanied by an increase in systolic pressure index and~     an improvement in the walking distance.~      Method: This is a trial with direct individual benefit, comparative, randomized, prospective,~     single-center, double-blind, versus placebo.~   "
110815|NCT02116972|"~     The purpose of this study was to assess the magnitude and duration of pain relief of a single~     IA injection of 2 doses (16 and 32 mg) of FX006, an extended-release formulation of TCA,~     relative to normal saline (placebo control).~   "
146831|NCT01644565|"~     The purpose of the study is to determine if immunization with a chimeric E. coli protein,~     dsc14CfaE-sCT2/LTB5, is safe and immunogenic when administered by vaccination under the skin.~   "
110801|NCT02117154|"~     This study aims to evaluate relative contributions of fasting plasma glucose and postprandial~     glucose at various HbA1c levels using 6-day CGM. Evaluation of the relationship between~     HbA1c, CGM, serum fructosamine and eAG, will also be looked into.~      HYPOTHESES:~        1. Fasting hyperglycaemia is the main contributor in Malaysian T2DM patients with poor~          glycaemic control (high HbA1c), postprandial hyperglycaemia plays a more important role~          with lower HbA1c levels.~        2. There is good correlation between HbA1c, CGM, serum fructosamine and eAG in Malaysian~          patients.~   "
110802|NCT02117141|"~     -  Assess the rate and extent of absorption of hydrocodone from a 20 mg HC-ER capsule in~          both fed and fasted states~        -  Evaluate the safety and tolerability of the test compound administered orally~   "
110803|NCT02117128|"~     We will investigate the efficacy and safety of using tranexamic acid by intravenous,~     intra-articular and combinational administration to reduce blood loss during total knee~     replacement. We hypothesize a combined intra-articular and single intravenous dose protocol~     of tranexamic acid may achieve a higher therapeutic concentration at the intra-articular and~     extra-articular bleeding site with little or no systemic absorption and subsequent systemic~     side effects.~   "
110804|NCT02117115|"~     Contrast-enhanced abdominal CT will be performed 1-2 weeks after allogeneic stem cell~     transplant, and radiographic evidence of mucosal inflammation will be correlated with the~     subsequent development of acute graft versus host disease. The primary endpoint is the~     feasibility and safety of contrast-enhanced abdominal CT in the early post-transplant period,~     as defined by the risk of contrast-related nephropathy or allergic reaction.~   "
110805|NCT02117102|"~     Urinary tract infection is most common serious bacterial infection in children who admit into~     the emergency department (ED). However the collection of urine from young children is time~     consuming process. So many children and their family guardian waste time until medical~     disposition established.~      In 2013, Maria Luisa Herreros Fernandez etc have suggested a new urine collection technique~     for newborn, that bladder and lumbar stimulation technique is fast and safe.~      The aim of this study is to determine clinical efficacy of bladder and lumbar stimulation~     technique (BLST) for pediatric patient in ED.~   "
110806|NCT02117089|"~     The purpose of this study is to investigate the combined training effectiveness of mechanical~     robot and neuromuscular electrical stimulation on upper limb rehabilitation after stroke.~   "
110807|NCT02117076|"~     The study will compare the safety, effectiveness and tolerability of gabapentin (Neurontin)~     versus gabapentin enacarbil (Horizant) as treatment restless leg syndrome.~   "
110808|NCT02117063|"~     The main purpose of this study is to determine if the Go Girls! program to take place at the~     Kluge Children's Rehabilitation Center Therapeutic Recreation Gymnasium, intended to~     introduce girls to a fun, non-threatening environment of exercise with peer support, improves~     scores on a physical activity enjoyment scale (PACES). Information regarding enjoyment of~     physical activity before and after the program will allow objective evaluation of whether the~     program is achieving its mission. Qualitative responses to the questionnaires will give~     program leaders a better sense of potential attitudes and barriers to regular exercise for~     teen girls. These responses will be used to shape activities during this or future programs~     for teens. Anthropometric (e.g. body weight, blood pressure, waist circumference) and~     biochemical (bloodwork) data will allow us to determine whether any change in metabolic risk~     factors can be seen from this 6-month once weekly intervention.~   "
110809|NCT02117050|"~     This is a Phase IV, prospective, open-label, multi-center trial to assess the treatment~     satisfaction in patients with relapsing forms of Multiple Sclerosis (MS) who are currently~     being treated with, but are considering discontinuing treatment with Tecfidera™.~   "
110810|NCT02117037|"~     This prospective study aimed to validate a new prognostic approach of endothelial progenitor~     cells associated biomarkers in patients with acute coronary syndromes . Recruitment is made~     prospectively by two centers of Inter -region South Mediterranean,~   "
110811|NCT02117024|"~     This study will test whether vaccination with viagenpumatucel-L combined with low-dose~     cyclophosphamide will prolong the survival of patients with non-small cell lung cancer~     (NSCLC) who have failed 2 or 3 prior lines of therapy for incurable or metastatic disease~     compared with chemotherapy alone. Patients will be randomized 2 to 1 into the~     viagenpumatucel-L arm and the chemotherapy alone arm, respectively.~   "
110812|NCT02117011|"~     Radiation therapy (RT) is often used to treat breast cancer. RT combined with breast surgery~     is associated with better outcomes in early stage breast cancer compared to surgery alone.~     Fatigue is one of the most important side effects of RT because it can decrease patients'~     quality of life.~      Studies found that physical activity (PA) may help to improve quality of life in cancer~     survivors. PA has been reported to lower fatigue, anxiety, and depression. Physical~     inactivity over a long period of time may lead to rapid energy and physical function loss.~      PA intervention studies in patients undergoing RT have included mostly White patients. There~     is no evidence on African American patients undergoing RT. The purpose of this study is to~     examine the efficacy of a structured, moderate-intensity, aerobic exercise program in~     reducing cancer-related fatigue in African Americans undergoing RT for localized breast~     cancer.~   "
110813|NCT02116998|"~     This is a randomized, double-blind, placebo-controlled study. Eligible subjects will be~     randomized in a 1:1 ratio to receive GEN-004 with adjuvant or placebo. Each subject will~     receive up to 3 doses at 4 week intervals.~      Following the third dose, subjects will be inoculated intranasally with S. pneumoniae~     serotype 6B. Nasal washes to identify S. pneumoniae colonization will be obtained~     pre-inoculation, and then 2, 7 and 14 days after inoculation.~      Subjects will also be monitored for safety and tolerability throughout the dosing period, and~     then for 12 months after their last dose.~      The purpose of this study is to evaluate the effectiveness of GEN-004 in reducing~     colonization rates and magnitude of colonization following the S. pneumoniae challenge.~   "
110814|NCT02116985|"~     Laparoscopic Cholecystectomy applied to Artificial pneumoperitoneum and the extent of~     Surgical stimulation cause the wave of hemodynamics increase vigorously, which make it~     difficult to judge the depth of anesthesia according to traditional hemodynamics index such~     as heart rate and blood pressure.In case of this, the investigators design this research to~     study the Closed-Loop Target Controlled Infusion to anaesthesia of individualization guided~     by a Narcotrend index monitor in Laparoscopic Cholecystectomy.~   "
146832|NCT01644552|"~     Patients with aniridia have positive angle kappas.~   "
110817|NCT02116946|"~     This is a randomized controlled clinical trial to investigate the effectiveness, safety and~     tolerability of platelet-rich plasma (PRP) injections for treatment of patellar tendinopathy~     in adults 18-50 years of age. Subjects will be randomly assigned to three parallel treatment~     groups:~        1. Leukocyte-rich PRP injection + exercise~        2. Leukocyte-poor PRP injection + exercise~        3. Saline injection + exercise (control) Primary endpoints are (1) the number (rate) and~          severity of adverse events as reported by both patients and study physicians during the~          first 12 weeks after initiation of treatment, (2) patient-rated tolerability of~          treatment; (3) the change in function (VISA score) and treatment success (global~          improvement scale) over six months of a post-injection exercise protocol.~   "
110818|NCT02116933|"~     Grafting of autologous stromal cell trial is a prospective study comparing routine fat~     grafting versus stromal vascular fraction enriched fat grafting.~   "
110819|NCT02116920|"~     AIM: To develop and standardize a cost effective methodology or algorithm for mRNA E6/E7 for~     HPV genotypes 16, 18, 31, 33 and 45 as compared to commercially available assays which can be~     incorporated to triage excess false positives from primary screening for cervical cancers~      Objectives:~        1. Development and standardization of methodology /algorithm for mRNA E6/E7 testing for HPV~          genotypes 16, 18, 31, 33 and 45 using Real-time RT-PCR, in cervical samples.~        2. To compare the test performance of this HPV E6/E7 mRNA assay to HPV DNA by HC 2 as~          secondary screening test, with the reference standard of colposcopy with biopsy, to~          triage women found positive in primary screening by VIA , in a population based~          screening for cancer of cervix.~        3. To determine number of false positives in the primary screening test after testing VIA~          positives with a known high specificity secondary screening test (HPV-DNA HC II )~          compared to HPV E6/E7 mRNA testing.~      Study Population: Women in the age group of 30-65 years, who test positive on primary~     cervical screening test VIA will be enrolled for the proposed diagnostic tests along with~     reference standard of colposcopy with guided biopsy.~      Methodology:~      Women in the age group of 30-65 years undergoing routine cervical cancer screening through~     hospital ( Preventive Oncology screening clinic) and community based screening programs with~     abnormal test result using the primary cervical cancer screening test VIA will be recruited~     in the study. The primary screening test VIA will be administered by application of 5% Acetic~     Acid to the cervix and visualizing the cervix with the help of a halogen focus lamp. VIA will~     be considered to be positive if definite acetowhite lesions are visualized close to the~     squamocolumnar junction.~   "
110820|NCT02116907|"~     This is an open-label, single-dose study in healthy male subjects. The study will have 2~     phases: Pretreatment and Treatment. The Pretreatment Phase will last up to 21 days and will~     consist of a Screening Period and a Baseline Period, during which each subject's study~     eligibility will be determined and baseline assessments will be conducted.~   "
110821|NCT02116894|"~     The primary objective of this open-label phase Ib trial is to determine the maximum tolerated~     dose and the recommended phase II dose for the combination of PF-03446962 plus regorafenib in~     patients with metastatic colorectal cancer. The secondary objectives are to describe the~     safety and tolerablility, and to describe the clinical activity of PF-03446962 plus~     regorafenib in terms of response rate and progression free survival~   "
110822|NCT02116881|"~     Despite of technological advances in surgery, incisional hernia and bowel obstruction remain~     frequent surgical complications. To date, the relationship between these two types of surgery~     and the occurrence of incisional hernia remains unclear. This is an observational study to~     evaluate outcomes of incisional hernia with respect to the incision site and adhesion-related~     bowel obstruction after open and laparoscopic colorectal surgery.~   "
110823|NCT02116868|"~     The purpose of this study is to determine whether analgesia guided by pupillary reflex during~     laparoscopic surgery is effective in opioid sparing (intraoperative remifentanil and~     postoperative morphine).This is a prospective, randomized, controlled study performed in two~     centers.~   "
110824|NCT02116855|"~     A multi centre two year long term escalating dose tertiary prophylaxis study on the efficacy~     and cost saving of individualized low dose prophylaxis regimens for boys with severe~     hemophilia A in China staring with a low dose regimen in step I, an escalated low dose~     regimen in step II and a tailored dose regimen based on individual PK profiles in step III.~     The dose escalation criteria are adjusted according to patterns and frequencies of joint~     bleeding and assessed in each subject every 3 months. Efficacy of the 3 different dose~     regimens are measured by the Annualized Joint Bleeding rate (AJBR) as a primary end point and~     the Hemophilia Joint Health Score (HJHS ) and QoL scores (CHO-KLAT and PedsQoL) , image~     studies of target joints by Ultrasound, X-ray and MRI examinations, consumption of factor~     VIII and inhibitor rates as secondary end points.~   "
110825|NCT02116842|"~     Local anaesthetics are highly toxic drugs. They can cause toxicity by an absolute overdose,~     accidental injection in a blood vessel or slow absorption from the area of injection. The~     risk of toxicity when performing regional anaesthesia can be reduced significantly by~     injecting the optimal dose of local anaesthetic at the correct site.~      To date most of the local anaesthetic dose finding studies for epidural labour analgesia has~     focused on ED50 ( the dose effective in 50% of patients). The purpose of this research study~     is to find out the ED95 dose (the dose effective in 95% of patients) of local anaesthetic for~     epidural analgesia in labour.~      The dose determined from this research trial will guide the anaesthetists to the optimal~     starting dose of the local anaesthetics for epidural analgesia in labour. This would lead to~     decreased chances of toxicity and will improve patient safety.~      We aim to recruit a total of 100 pregnant patients in early labour (cervical dilatation ≤ 5~     cm) requesting epidural analgesia to answer the research question based on the continual~     reassessment method. Patients will be recruited according to well-defined criteria. They will~     be fully informed about the study and have the choice of not participating or opting out at~     any time during the study. It is not going to affect the kind of treatment they receive. The~     experts in the field with full safety precautions will perform this study at St James'~     Hospitals, Leeds.~   "
110826|NCT02116829|"~     The aim of this study is to examine the effects in humans of a moderate butter intake on risk~     markers of cardiovascular disease compared to a diet with the same amount of olive oil~     (refined and therefore without polyfenols).~      The primary parameters are total cholesterol, LDL- and HDL cholesterol and triglycerides. The~     secondary parameters are risk markers of diabetes type 2; plasma glucose and insuling as well~     as the inflammatory marker hs-CRP.~   "
110827|NCT02116816|"~     This study consists of two parts. The first part of the study looked at the absorption of~     three different polyphenol preparations into the blood, the variability of their absorption~     and whether their absorption could be enhanced by mixing with pollen shells. For this purpose~     12 healthy volunteers were recruited. All participants received all the 3 supplements with~     and without mixing with pollen shells so they had a total of 3 tests. For each test six blood~     samples were taken over an 8 hour period. Urine samples were also collected.~      Oligopin was selected from the first study. The second part of study aims to look at the~     effects of Oligopin on endothelial function by assessing vascular tone and function in~     healthy volunteers using a non-invasive, direct measurement of vasodilatory capacity~     (EndoPAT). Nitrate and nitrite measurements, as well as blood pressure measurements, will~     also be recorded to provide a clear clinical assessment of the effects of this preparation~     (if any) upon vascular function. The effects of Oligopin will be compared to a placebo~     (methylcellulose-filled capsules) to allow a robust assessment of any clinical effects. A~     total of 24 healthy volunteers will be recruited for this study.~   "
110828|NCT02116803|"~     The study allowed continued safety follow-up of patients who were on single agent dovitinib~     or dovitinib in combination with fulvestrant treatment in a Novartis-sponsored study which~     had met its primary endpoint and were benefiting from the treatment as judged by the~     investigator.~   "
110829|NCT02116790|"~     Findings from the investigator's lab and others' show the involvement of the brain's~     mesolimbic circuitry in pain perception and evaluation, as well as during the transition from~     acute to chronic pain states in both humans and animals. Dopamine (DA) is one of the main~     neurotransmitters in this circuitry, and it is possible it could have an intimate role in~     pain processing, chronicity, and related anatomical and functional neuroplasticity. In this~     study, the investigators first need to know if the combination of l-dopa and Naproxen is safe~     and efficacious in humans with acute pain, and if so, at what doses. For the present study,~     healthy pain-free participants will be injected with a small bolus of capsaicin~     subcutaneously to induce acute cutaneous inflammatory pain. Capsaicin is ideal for this study~     because it causes a characteristic inflammatory response that is almost always accompanied~     with pain, has a well-validated dose-response curve, and has effects that will go away~     completely in a few hours after administration, causing no permanent damage to study~     subjects. Effects of capsaicin will be measured by changes (decreases) from baseline in~     thermal and tactile thresholds, as well as by verbally reported cutaneous pain levels (on a~     scale from 0-10). Participants will also be given study medication in the form of a placebo,~     one drug, or a combination of drugs before capsaicin injection to allow for any analgesic~     effects to peak before pain onset. For those receiving active medication, they will either~     receive Naproxen with placebo or the combination of naproxen and l-dopa (the latter of which~     will be in one of two different doses). This will allow the investigators to investigate (1)~     whether co-administration of naproxen and l-dopa has analgesic effects in low levels of acute~     pain in humans, (2) if this combination is pain-alleviating, whether it is equally as or more~     efficacious than naproxen, which is the clinical standard of treatment, and finally (3) what~     dose provides the most analgesia.~   "
110830|NCT02116777|"~     This phase I/II trial studies the side effects and best dose of talazoparib and temozolomide~     and to see how well they work in treating younger patients with tumors that have not~     responded to previous treatment (refractory) or have come back (recurrent). Talazoparib may~     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs~     used in chemotherapy, such as temozolomide, work in different ways to stop the growth of~     cancer cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Giving talazoparib together with temozolomide may work better in~     treating younger patients with refractory or recurrent malignancies.~   "
110831|NCT02116764|"~     This study is a longitudinal and cross-sectional evaluation of patients with Chronic~     Granulomatous Disease (CGD) who received or are receiving hematopoietic cell transplantation~     (HCT) for their disease under a variety of protocols used by participating institutions~     compared to a control non-HCT group receiving standard care. Investigators at multiple~     centers caring for patients with CGD in North America and 3 centers in Europe will~     participate. Patients with CGD will have been treated according to institutional practice and~     protocols. Investigators will enroll these patients as subjects in this protocol. This study~     will investigate which patients benefit most from HCT, and what types of transplants are~     optimal for patients with CGD, in the context of overall outcomes in CGD patients with and~     without transplant.~   "
110832|NCT02116751|"~     The purpose of this study is to determine the frequency of renal and bone toxicity in HIV~     infected patients receiving antiretroviral therapy, and the outcome in terms of treatment~     change or/and virological failure, in relation with the presence of classical factors, such~     as diabetes or hypertension, the role of HIV itself, because of chronic inflammation, and the~     effects of antiretroviral medication.~   "
110833|NCT02116738|"~     The investigators want to share our study that is the Comparison of Modified Limberg Flap~     Transposition and Lateral Advancement Flap Transposition with Burrow's Triangle in the~     Surgical Treatment of Sacrococcygeal Pilonidal Sinus.~   "
110834|NCT02116725|"~     Zinc is an important metal for the maintenance of healthy skin and wound healing. Washing~     with detergents e.g. shower gels may deplete the zinc stores in the skin.~      The purpose of our study is to see whether repeated washing with zinc containing shower gel~     of superficial wounds will result in increased healing.~   "
110835|NCT02116712|"~     Lymphangioleiomyomatosis (LAM) is a rare lung disease that mostly affects women of~     childbearing age. In LAM, abnormal, muscle-like cells begin to grow out of control in the~     lungs. As a result, air can't move freely in and out of the lungs. In some cases, this means~     the lungs can't supply the body's other organs with enough oxygen.~      This study is being conducted to find out what dose of a drug called saracatinib is best~     tolerated by people with LAM. This drug has been tested in patients with certain types of~     cancer but is not currently approved by the United States Food and Drug Administration (FDA).~     Saracatinib may work in cancer by preventing the growth, movement and invasiveness of cancer~     cells. The use of saracatinib to treat LAM is considered experimental. Preliminary testing~     already completed suggests that the study drug, saracatinib, may suppress certain substances~     in the lungs of patients with LAM thus may be effective in slowing down the disease process~   "
110836|NCT02116699|"~     Extremely premature (BW<1250g) infants are at high risk for morbidity and mortality. Own~     mother's colostrum (OMC) and milk (OMM) protect against neonatal morbidity and are rich in~     immune factors which may provide immunostimulatory effects when administered oropharyngeally~     to extremely premature infants during the first weeks of life. The investigators hypothesize~     that infants who receive oropharyngeal mother's colostrum and milk will have significantly~     lower rates of infection and improved health outcomes, compared to infants who receive a~     placebo.~   "
110837|NCT02116686|"~     The prevalence of sleep disordered breathing (SDB) reaches more than 50% in chronic heart~     failure patients (CHF). The main consequence is an increase risk of fatal and non-fatal~     cardiovascular events. A treatment by continuous positive airway pressure (CPAP) or~     adaptative servo-ventilation (ASV) reduces this risk. Nevertheless, 75% of severe SDB cases~     remains undiagnosed and untreated especially due to cost and time delay for polysomnography~     examination which is the gold standard for SDB diagnosis. Indeed, alternative methods are~     developed. Some methods, based on nocturnal ECG analysis showed promising results but they~     are not validated and adapted for cardiac population. Thus, the goal of present study is to~     test the accuracy of ECG derived respiration signal to screen SDB in a CHF population.~   "
110838|NCT02116673|"~     Background: Head injury is a common presentation to family medicine clinics and emergency~     departments (EDs), and the majority will not result in intracranial injury requiring~     neurosurgical consultation, but will have symptoms of mild traumatic brain injury (MTBI). It~     is estimated between 15-50% of patients with MTBI develop post-concussive syndrome (PCS).~     Research in the management of MTBI and prevention of PCS has been scarce to date. Although~     expert consensus recommends cognitive rest and graduated return to usual activities, these~     and other interventions are not based on prospective clinical evidence.~      Objective: The purpose of this study is to determine if providing graduated return to usual~     activities discharge instructions to MTBI patients in the ED decreases MTBI symptoms~     post-injury as compared to providing usual ED MTBI discharge instructions.~      Study Design: This will be a pragmatic, single-centered, 2-arm parallel-group, superiority~     randomized trial.~      Patient Population: Male and female patients presenting to the ED ages greater than 17 and~     less than 65 with the Canadian Emergency Department Information System (CEDIS) presenting~     complaint of head injury.~      Outcomes: The primary outcome of this study is to determine if patients whom receive~     graduated return to usual activity discharge instructions have more clinically significant~     decreases in their Post-Concussion Symptom Score (PCSS) 2 weeks after MTBI versus patients~     who received usual care MTBI discharge instructions. Secondary outcomes include the~     intervention group's compliance with the intervention, comparison of PCSS between groups 4~     weeks after initial ED visit, comparison of groups' number of return visit(s) to either an ED~     or physician's office, and the mean number of days of school or work missed for each group.~      Hypothesis: Given cognitive rest and graduated return to usual activities are concepts~     recommended by expert consensus, it is expected patients who follow the graduated return to~     usual activities and cognitive rest guidelines will have less MTBI symptoms at two weeks~     after ED discharge.~   "
110839|NCT02116660|"~     To evaluate changes in renal function, efficacy, and safety when switching from a combination~     of tenofovir/emtricitabine (TDF/FTC) plus a protease inhibitor/ritonavir (PI/r) to a~     combination of raltegravir (MK-0518) plus nevirapine plus lamivudine in human~     immunodeficiency virus (HIV)-1 participants with suppressed viremia and impaired renal~     function.~   "
110840|NCT02116647|"~     In India, precisely northern states, skewed sex ratios, female feticide and higher child~     mortality rates for girls have become serious concern. The female child mortality as a result~     of son preference have increased during the last several decades .Since families cannot know~     the sex of the fetus due to Indian government policies, maltreatment and serious neglect has~     been tools to ensure there are few survivors.~   "
110841|NCT02116634|"~     Whether the mesenchymal injection on ALS patients is effective or not?~   "
110842|NCT02116621|"~     Chronic musculoskeletal pain is an important problem, and treatments are often prescribed in~     a trial and error fashion. Clinicians prescribe a treatment to a patient and then wait and~     see if the treatment is successful. If the treatment is unsuccessful, they will try a~     different treatment. The disadvantage to this method is that it may take a long time to find~     a successful treatment.~      The purpose of the PREEMPT Study is to test whether using a mobile phone application~     (Trialist app) that allows patients and their health care providers to run personalized~     experiments comparing two pain treatments is more effective than usual care. Patients~     download the app, and working with their clinicians, set up a personalized trial that makes~     sense for them. Every day they answer questions to track levels of pain and side effects of~     treatment, such as fatigue and constipation. Once the personalized trial has ended, the~     responses to these daily questions on each treatment will be compared. During a regular~     clinic visit, the patient and the clinician will review visual displays of the results to~     facilitate treatment decision-making. Approximately 250 patients will be enrolled in the~     study. Half the patients will use the app and review results with the clinician, and half the~     patients will continue with their regular care (i.e., will not use the app). The two groups~     will be compared to see if using the app is successful in improving long term pain outcomes.~     The goal of the intervention using the Trialist app is to help patients engage actively and~     collaboratively with their clinicians and identify effective treatments more quickly.~   "
110843|NCT02116608|"~     This study plans to learn more about the different ways used to treat tracheostomy~     granulomas. Investigators want to see which standard of care method (steroid application,~     silver nitrate, or betadine) is more successful in treating tracheostomy granulomas.~   "
110844|NCT02116595|"~     Presently, the gold standard for testing diet acid intake is a urine collection done for many~     hours, usually 24 hours, which must be analyzed in a research lab for net acid excretion.~     So, getting information about diet acid intake is difficult. Many people have suggested doing~     a much simpler test, which is checking the pH of the urine when you wake up. But, no one has~     studied if this simpler method is a valid method for estimating the 24 hour net acid~     excretion. Diet acid load may be important in many diseases associated with aging, such as~     loss of bone and muscle, and the development of kidney disease.~   "
110845|NCT02116582|"~     The objective of this study was to evaluate the efficacy and safety of enzalutamide treatment~     in patients with progressive metastatic castration-resistant prostate cancer previously~     treated with abiraterone acetate.~   "
110846|NCT02116569|"~     The purpose of this study is to evaluate the tolerability and safety of Daratumumab in~     Japanese participants with relapsed (the return of a medical problem) or refractory (not~     responding to treatment) multiple myeloma (cancer of plasma cells in bone marrow,~     characterized by the presence of abnormal proteins in the blood).~   "
110847|NCT02116556|"~     Acute alcoholic hepatitis (AAH) is a serious condition and one of the most frequent causes of~     Acute-on-Chronic Liver Failure. The current standard therapy (corticosteroids) is theme of~     debate and unsatisfactory in many patients (year mortality: 30%). One of the main causes of~     death is bacterial infections, which affect 40-50% of patients at 90 days. Intestinal~     decontamination with rifaximin (a nonabsorbable antibiotic) reduces endotoxemia, improves~     liver function and reduces the complications of decompensated alcoholic cirrhosis.~      The Hypothesis/Objective: To assess whether oral decontamination with rifaximin prevents the~     development of infections associated with AAH and analyze its consequences.~   "
110848|NCT02116543|"~     This proof of concept study is designed to evaluate the safety, tolerability,~     pharmacokinetics, and antiviral activity of TD-6450 in treatment naïve subjects with GT-1,~     GT-2 or GT-3 chronic HCV.~   "
110849|NCT02116530|"~     This randomized phase III trial studies antiemetic therapy with olanzapine to see how well~     they work compared to antiemetic therapy alone in preventing chemotherapy-induced nausea and~     vomiting in patients with cancer receiving highly emetogenic (causes vomiting) chemotherapy.~     Antiemetic drugs, such as palonosetron hydrochloride, ondansetron, and granisetron~     hydrochloride, may help lessen or prevent nausea and vomiting in patients treated with~     chemotherapy. Olanzapine may help prevent chemotherapy-induced nausea and vomiting by~     blocking brain receptors that appear to be involved in nausea and vomiting.~   "
110850|NCT02116517|"~     Green tea is one of the most popular beverages in the world. It is believed to have~     beneficial effect in prevention and treatment of many diseases, one of which is reducing~     LDL-C. The aim of the study is to examine the effect of supplement containing GTE on obese~     with high LDL level.~   "
110851|NCT02116504|"~     One of the main potential causes of these failures of BP therapy response is the development~     of Anti-drug Anti-body (ADAb) in some patients. ADAb may decrease the efficacy of BPs by~     neutralizing them or modifying their clearance and they may be associated with BP-specific~     hypersensitivity reactions. The prediction, prevention and cure of anti-drug (AD)~     immunization are thus major goals in BP development. This prospective study (ABI-RA) will~     assess the occurrence of ADAb using standardized and validated assay(s) and also cellular,~     genetic and molecular parameters in RA/JIA patients treated with adalimumab, etanercept,~     infliximab and rituximab or tocilizumab, to address the mechanism of immunogenicity.~     Patient-related factors that might predispose an individual to an immune response will be~     taken into account: underlying disease, genetic background, immune status, including~     immunomodulating therapy and dosing schedule.~   "
110852|NCT02116491|"~     BACKGROUND: The investigators developed a fiber-optic-guided endotracheal suction catheter~     (visual sputum suctioning system or VSSS), which the investigators previously tested in vitro~     and animals. It integrates a 0.9-mm micro-imaging fiber into a 3.7-mm double-lumen catheter.~      PURPOSE: The purpose of this study was to investigate the safety and efficacy of sputum~     suctioning system in mechanical ventilated patients in respiratory intensive care unit~     (RICU). The investigators compare the weight of secretions collected, vital signs, and~     tracheal wall injury between two groups of patients randomized to have VSSS combined with~     closed system suction (CSC) suction and patients having CSC suction alone.~      HYPOTHESIS: The investigators theorized that the VSSS collected more sputum and caused less~     change of vital signs than conventional CSC.~   "
110853|NCT02116478|"~     The purpose of the study is to compare the clinical results for patients suffering from~     plantar fasciitis treated with gastrocnemius recession vs. conservative treatment.~   "
110854|NCT02116465|"~     The study is carried-out to describe and compare the plasma pharmacokinetics of levodopa and~     carbidopa after oral single-dose administration of 100 mg levodopa plus 25 mg carbidopa by~     means two fixed combination products (test: Isicom® 100/25 mg; reference: Nacom® 100/25 mg).~      Additionally, to describe and compare the safety and tolerability of the two investigational~     treatments administered to healthy subjects.~   "
110855|NCT02116452|"~     The study objective is to evaluate whether a specific prebiotic (GOS/PDX) may have an effect~     in preventing atopic dermatitis, food allergy, intestinal and/or respiratory infections in~     infants at risk of atopy. In infants with dermatitis, the hypothesis will be tested that~     prebiotics reduce the severity of the disease.~   "
110856|NCT02116439|"~     The main objective of this study is to determine the average total number of violent events~     per observation period occurring in the emergency department at the Nîmes University~     Hospital. The list of violent events is pre-determined and based on a series of interviews~     with emergency department staff.~   "
110857|NCT02116426|"~     The main objective of our study is to evaluate the diagnostic value of copeptin testing in~     association with troponin HS testing during pre-hospital care (ambulance care) in the~     treatment of patients whose pattern of use is the occurrence chest pain suggestive of ACS but~     not ST+.~   "
110858|NCT02116413|"~     The main objective of this study is to evaluate in a population of patients with septic shock~     receiving 500 ml crystalloid over 10 minutes, the proportion of patients classified as~     responders to the fluid challenge (increase of at least 15% of ITV in aortic) at the end of~     vascular filling (T10) and becoming non-responders 20 minutes after the end of the fluid~     challenge (T30) and whether this proportion is greater than 10 points.~   "
110859|NCT02116400|"~     The main objective of this study is to evaluate decision-making using the Iowa Gambling Task~     (IGT) among patients with euthymic bipolar disorder according to their personal history of~     suicide attempt (suicidal vs. not suicidal ).~   "
110860|NCT02116387|"~     The main objective of this study is to evaluate in patients with chronic low back pain~     (lasting for more than 3 months and not postoperative) the effect of an instrumental~     rehabilitation using the I-Moove ® device compared to a conventional physiotherapy~     rehabilitation for ambulatory postural stability (mean and standard deviation of excursions~     from the center of gravity) without visual control, 6 weeks after the start of the~     rehabilitation protocol. We focus on the relative variation between the values obtained on~     day 0 versus 6 weeks, via measures performed on a force platform. The results will be~     stratified into 3 age groups (18-39 years, 40-60 years and over 60 years).~   "
110861|NCT02116374|"~     The bacterial diversity of HIV patients digestive microbiota seropositive is poorly~     understood, it remains to be defined.~   "
110862|NCT02116361|"~     This study will evaluate the safety and efficacy of onabotulinumtoxinA (BOTOX®) compared with~     placebo as treatment for major depressive disorder (MDD) in adult females.~   "
110863|NCT02116348|"~     Cerebral palsy (CP) is the most frequent cause of motor handicap among children. The economic~     burden of CP in USA includes $1.18 billion in direct medical costs, $1.05 billion in direct~     non-medical costs, and an additional $9.24 billion in indirect costs, for a total cost of~     $11.5 billion or $921,000 average cost per person. Associated disabilities as mental~     retardation, delayed speech development add psychological burden of the disease on the family~     as well as economic burden.~      Mental retardation is the major problem in children with cerebral palsy. Improving mental~     development will have a positive effect on quality of life for the child and his family.~     Treating associated impairments (mental retardation) with Cerebrolysin will improve mental~     development and quality of life, and will decrease the economic burden in children with~     cerebral palsy.~   "
110865|NCT02116322|"~     This research is being done to investigate if a new technique to biopsy the pancreas will~     lead to a larger amount tissue material that can be analyzed. Investigators have called the~     technique the corkscrew technique and believe it will allow obtaining a larger biopsy~     sample during the endoscopic ultrasound examination. The corkscrew technique uses a clockwise~     rotational movement to drive the needle into the pancreatic mass (like a wine bottle opener~     twists and buries itself into a cork). It is believed that this will lead to a better biopsy~     sample than the usual way and therefore result in a higher chance of a diagnosis.~   "
110866|NCT02116309|"~     This research is being done to see if using a combination of rectal indomethacin and~     epinephrine spray during endoscopy, can prevent pancreatitis that may occur after ERCP (a~     type of gastrointestinal endoscopy).~   "
110867|NCT02116296|"~     The ToyBox proposal addresses Knowledge-Based Bio-Economy (KBBE)-2009-2-1-03 - Behavioural~     models for prevention of obesity, with a particular focus on children. It will primary aim to~     influence children's behaviours and prevent obesity in early childhood. The proposal will~     identify key behaviours related to early childhood obesity and their determinants and~     evaluate behavioural models and educational strategies. Based on the obtained insights at a~     local level, a multidisciplinary team will develop and implement a school based family~     involved intervention programme that could be applied on a European scale. Process, impact,~     outcome and cost-effectiveness evaluation will be conducted to support decision making for~     European Public Health Policy. The combined use of Precede-Proceed Model and Intervention~     Mapping will provide the framework for the development, implementation and evaluation of the~     ToyBox intervention. To achieve this, the project will be subdivided into 10 Work Packages~     (WPs). This carefully planned stepwise approach will include systematic reviews, secondary~     analyses of existing data sets, focus group research and school policies overview. The ToyBox~     project consortium spans the necessary multidisciplinary variety of experts such as public~     health experts, epidemiologists, nutritionists, physical activity experts, pedagogists,~     psychologists, behavioural scientists, nutritionists, paediatricians, early childhood~     psychologists, health economists, totalling 15 partners, from 10 countries. The consortium,~     consists of 11 universities, 1 research institute, 2 advocacy groups and a small to medium~     enterprise (SME) representing all regions of Europe. The consortium has ample experience in~     conducting and coordinating multi-centre international research as well as undertaking~     dissemination activities to all relevant stakeholders.~   "
110868|NCT02116283|"~     Smokers will use a smartphone app on a smartphone provided for the study that will passively~     sense and record information about their activities. Information collected from the~     smartphone app will be used to develop future smartphone apps that will predict when an~     individual is at risk of smoking.~   "
110869|NCT02116270|"~     The aim of this study is to investigate the impact of renal function and dialysis techniques~     on the percentage of senescent T lymphocytes.~   "
110870|NCT02116257|"~     While Patient-controlled analgesia (PCA) has the advantage of effectively reducing the degree~     of postoperative pain, it can also affect the patient's outcome by several adverse effects~     such as postoperative nausea and vomiting (PONV). Especially for high risk group of patients~     for PONV, the ideal regimen for sufficient analgesia with minimal adverse effect needs to be~     sought. Propacetamol is known for its effective, rapid analgesia, opioid-sparing effect, and~     is used widely for post operative pain management. This study aims to see the opioid-sparing~     effect and the degree of PONV when propacetamol is added to PCA for high risk PONV patients.~   "
110871|NCT02116244|"~     Keratoconjunctivitis sicca (KCS) or Dry Eye Syndrome is a disease of the surface of the eye,~     tear film, and related ocular tissues. Millions of people suffer from one form of the disease~     or another and its prevalence increases with age. Dry Eye Syndrome sufferers experience a~     broad range of symptoms including discomfort, irritation, burning, itching, redness, pain,~     gritty feeling, foreign body sensation, blurred vision and ocular fatigue. Civamide is a~     TRPV-1 receptor modulator that causes the initial stimulation of neuropeptide release and~     subsequent desensitization to further stimulation of the trigeminovascular system. This~     provides a pharmacological rational for intranasal route of administration for disorders~     mediated by the trigeminal nerve or involving the cranial nerve. In nine clinical studies of~     Civamide Nasal Solution, over 50% of the nearly 300 patients who received Civamide via~     intranasal administration experienced lacrimation (tearing). This led to the hypothesis that~     Civamide Nasal Solution might be an appropriate treatment for Dry Eye Syndrome.~   "
110872|NCT02116231|"~     The study is designed to compare Intensity Modulated Radiotherapy (IMRT) in combination with~     concurrent chemotherapy and IMRT alone in treatment of stage II nasopharyngeal carcinoma.~   "
110873|NCT02116218|"~     Pain control is a common and serious problem in cancer patients. Although WHO has developed a~     three-stage model of cancer pain management, 80% cancer patients still suffer moderate to~     severe pain in their daily life. When patients are with acute exacerbation or aggravate of~     pain, they usually visit the emergency department for more help.~      Acupuncture is a safe, low-invasive and economic treatment. And it has been world-wide used~     as a complementary therapy among patients with cancer. It can not only relieve pain in cancer~     patients, but also can reduce some of the side effects caused by some treatment.~      This study is aimed to evaluate the efficacy and safety of acupuncture in cancer patient with~     acute pain onset through emergency department with objective Traditional Chinese Medicine~     assessment.~   "
110874|NCT02116205|"~     The purpose of this study is to compare the immune responses of two different doses (1.0 mg~     and 2.0 mg) and two different dosing schedules (two doses or three doses) of a mixed Hantaan~     virus (HTNV) and Puumala virus (PUUV) DNA vaccine in healthy participants. To maintain a~     blind, participants in the two-dose group will receive one dose of normal saline placebo. All~     of the groups will also receive a booster dose 6 months after first vaccination. The results~     will help to determine which dose and vaccination schedule will be best to move forward in~     the vaccine development process.~   "
110875|NCT02116192|"~     This research study intends to learn about whether early intervention can help to prevent~     non-alcoholic fatty liver disease (NAFLD) in adolescents. Potentially eligible adolescents~     who are seen at the University of Wisconsin (UW) Pediatric Fitness Clinic will be asked to~     join the study. Patients who agree to participate in the study will be randomized into either~     the intervention group or the control group. The intervention group will follow a~     low-fructose diet. In addition, participants will be asked to return to the clinic for 4~     follow-up visits during a 6-month interval.~   "
110921|NCT02115594|"~     Preclinical data has demonstrated that entinostat (SNDX-275) can enhance fulvestrant~     sensitivity in hormone receptor-positive breast cancer in animal models. The addition of~     entinostat to fulvestrant will provide clinical benefit to patients with locally advanced or~     metastatic breast when compared to fulvestrant plus placebo. Also, based on previous data,~     patients exposed to entinostat who demonstrate an elevated level of protein lysine~     acetylation will have an improved efficacy outcome.~   "
110876|NCT02116179|"~     The purpose of the study are the following: 1) Pilot test and conduct baseline and 3 month~     follow up assessments to evaluate the preliminary efficacy of the DVD-based HIV/HCV~     intervention by randomly assigning 210 Latino corrections-involved, outpatient abuse~     treatment clients to either the experimental intervention or to a wait list control group;~     and 2) to evaluate both participant and interventionist acceptability of this novel DVD-based~     intervention.~      They study hypothesis are the following:~        1. participants in the intervention condition will report greater reductions in sexual risk~          behaviors (e.g., unprotected sexual contact) from baseline to 3 month follow-up compared~          to the control group;~        2. participants will report greater reductions in drug risk behaviors (e.g., sharing~          injection equipment, drug use during sex) from baseline to 3 month follow-up compared to~          the control group;~        3. participants who report more HIV prevention information, motivation, and behavioral~          skills will report fewer sexual risk behaviors.~   "
110877|NCT02116166|"~     The purpose of this research study is to investigate how and why the loss of muscle mass~     occurs with aging. Tissue collected from young subjects will be compared to previously~     collected tissue from elderly subjects, as well as previously collected data on muscle~     function/mass to further investigate cellular and molecular pathways that have recently been~     shown to be important for the aging process in muscle. The Principal Investigator (PI) and~     the study team will look for specific proteins (called biomarkers) that can be present in the~     muscle tissue in various amounts in different individuals. This study will increase the~     investigators understanding of the processes of muscle atrophy (loss of mass) and functional~     loss at older age and will help to find new treatments and interventions aimed at improving~     the quality of life and independence of America's rapidly expanding elderly population.~   "
110878|NCT02116153|"~     Biomarkers play a key role in the diagnostic workup of patients presenting to an emergency~     department (ED). European and American guidelines recommend cardiac Troponin (T or I) as the~     biomarker gold standard for the diagnosis of non-ST-elevation myocardial infarction~     (non-STEMI). Today, high-sensitivitiy assays are available and allow an early diagnosis of~     non-STEMI and the detection of troponin in individuals that would have been classified as~     unstable angina with former assays. As many patients are detected with elevated troponin~     values with the high sensitivity assays, specificity for non-STEMI has inevitably decreased.~     Micro-RNAs (mi-RNA) are new biomarkers with a wide spectrum of detectable conditions that~     allow specific identification of myocardial infarction. The aim of this study is to develop a~     biomarker protocol that combines the high sensitivity of cardiac Troponin T and the high~     specificity of mi-RNA profiles for early and safe identification of non-STEMI in ED patients.~   "
110879|NCT02116140|"~     Obstructive sleep apnea (OSA), central sleep apnea (CSA) and heart failure (HF) are states of~     metabolic demand and sympathetic nervous system (SNS) activation. In patients with sleep~     apnea and HF, continuous positive airway pressure (CPAP) initially may reduce left~     ventricular (LV)stroke volume (SV) but subsequently improves and LV function. This may relate~     to an early beneficial effect on myocardial energetics through early reduction in metabolic~     demand that subsequently leads to improved efficiency of LV contraction. However, it is not~     clear whether long-term adaptive servo-ventilation (ASV) favorably affects cardiac~     energetics. Any such benefit may also relate to reduced sympathetic nervous system (SNS)~     activation. However its effect on myocardial SNS function is also not well studied.~      In a pilot study we demonstrated early (6 week) beneficial effects of CPAP in patients with~     OSA and HF. The current proposal (AMEND) is a unique substudy of the recently funded~     ADVENT-HF trial (Adaptive Servo Ventilation for Therapy of Sleep Apnea in HeartFailure)~     (NCT01128816; CIHR; D. Bradley, PI).~      We propose to evaluate the long-term (6 month) effects of ASV on daytime 1) oxidative~     metabolism; 2) the work metabolic index (WMI) as an estimate of mechanical efficiency; 3)~     myocardial sympathetic nerve (SN) pre-synaptic function; and 4) heart rate (HR) variability~     in patients with HF and coexisting OSA or CSA. In conjunction with echocardiographic measures~     of LV stroke work, positron emission tomography (PET) derived [11C] acetate kinetics will be~     used as a measure of oxidative metabolism, to determine the WMI. [11C] hydroxyephedrine (HED)~     retention will be used to measure cardiac SN pre-synaptic function.~      Primary Hypotheses: In patients with chronic stable HF and CSA or OSA without excessive~     daytime sleepiness (EDS), long-term (6-month) ASV therapy yields:~        1. Beneficial effects on daytime myocardial metabolism leading to a reduction in the rate~          of oxidative metabolism as measured by [11C]acetate kinetics using PET imaging;~        2. Improvement in energy transduction from oxidative metabolism to stroke work as measured~          by an increase in the daytime work-metabolic index.~   "
110880|NCT02116127|"~     The purpose of this pilot study is to examine the feasibility of conducting a multi-site~     double-blind randomized controlled trial whose aim will be to evaluate the effectiveness of~     transcranial direct current stimulation (tDCS) for treatment in pregnant women with moderate~     to severe major depression.~   "
110881|NCT02116114|"~     We have as hypothesis that the aquatic aerobic physical training program can help promote~     beneficial adaptations on the cardiovascular, respiratory and systemic inflammation~     variables, functional capacity and quality of life in patients with chronic obstructive~     pulmonary disease (pulmonary emphysema).~   "
110882|NCT02116101|"~     This was a randomized, double-blind, single-center, placebo-controlled, two-arm study. The~     objectives of this study were to evaluate the effect of Momchilovtsi yogurt on:~        1. Improving intestinal digestion and bowl movement;~        2. Adjusting blood total Cholesterol and Triglycerides levels;~        3. Adjusting microbiological flora (Clostridium perfringens bacteria, Lactobacillus and~          Bifidobacterium) in gastrointestinal tract;~        4. Adjusting short chain fatty acids (acetic acid, propionic acid, butyric acid) in in~          gastrointestinal tract.~   "
110883|NCT02116088|"~     Children with externalizing problem behaviour are at risk of developing educational~     impairment, because of their problems in rule following, social behaviour and attention. This~     behaviour represents a great challenge for teacher. In addition, time pressures and conflicts~     with colleagues are the most common sources of stress for teachers. Till now teachers receive~     no evaluated training which in particular regards externalizing problem behaviour. Therefore~     we develop and evaluate an indicated prevention program for elementary school teachers with~     children with externalizing problem behaviour. All teachers of a participating school are~     given a general overview of externalizing problem behaviour (etiology, diagnosis) and~     information on evidence-based treatments for children with externalizing problem behaviour in~     school settings. Single teachers will then participate in a 12 week coaching in which they~     learn to apply classroom management techniques, strategies to improve their relationships~     with children, behaviour modification techniques and cognitive interventions to specific~     target children. The coaching intervention is based on functional behavioural analysis and~     provides teachers with evidence-based strategies which focuses on one target child.~      Longitudinal data will be collected in a within-subject control group design. Dependent~     measures include teacher and observer reports.~   "
110884|NCT02116075|"~     Study comparing caudal prolotherapy to conventional steroid for chronic low back pain~   "
110885|NCT02116062|"~     The introduction of surgical robots in the OR revolutionized a number of specialties (i. e.~     urology, gynecology, digestive surgery). Robots are currently used in many situations and the~     list of appropriate indications is growing rapidly. There are many potential advantages of~     robotics in eye surgery such as increased precision and maneuverability, better ergonomics,~     improved patient access to surgeons and surgical training. As a result, robotics might~     improve patient care. The Da Vinci© robot has been used for 10 years in experimental~     conditions to suture corneal lacerations, to perform corneal grafts, to remove ocular foreign~     bodies, lens capsules and vitreous. The authors reported a lack of precision resulting from~     poor visualization and the absence of microsurgical instruments. These elements were~     considered to be hurdles to further clinical investigation. The new Da Vinci Si HD© robot has~     been available since 2009 at the IRCAD center and more recently in Strasbourg University~     Hospital. It provides greater magnification and better resolution of the operative field than~     the previous model. We performed since 2012 various ocular surface surgeries on porcine eyes~     at the IRCAD center. The aim of the present trial is to perform the same procedures (amniotic~     membrane transplantations, pterygium surgeries, corneal grafts) in a clinical setting with~     the Da Vinci Si HD© system.~   "
110886|NCT02116049|"~     Men who have sex with men (MSM) remain disproportionately represented in the national~     HIV/AIDS statistics. Little progress has been made in understanding the nuances of MSM sexual~     behavior or communication that may be perpetuating the spread of HIV. Non-disclosure of an~     HIV-positive status may be a key factor responsible for male-male HIV transmission. There are~     no known intervention programs whose primary focus is to help MSM develop requisite skills to~     disclose their status to casual sexual partners. The development of such interventions is~     essential because of the numerous repercussions for not disclosing when one is HIV-positive~     such as legal prosecution and the transmission of HIV. In a previous intervention development~     study (R21MH067494) the research team created and tested a 4 session intervention found to be~     promising for increasing disclosure to casual sexual partners. The purpose of the proposed~     research is to further refine and enhance our HIV disclosure intervention (DI) designed to~     increase disclosure to casual sexual partners and reduce sexual risk taking behaviors among~     HIV-positive MSM; assess the relative effectiveness of a disclosure intervention to an~     attention control case management group (ACCM) for HIV-positive MSM; examine the effects of~     the intervention over time; explore differential treatment responses to the disclosure~     intervention and ACCM on the basis of ethnicity, age, and education level as well as examine~     the mediating effect of baseline frequency of sexual activity, severity of substance abuse at~     baseline, and stigmatized fear on the relationship between intervention type and the outcome.~     Finally, the investigators will test how treatment engagement, retention and expectations~     predict subsequent disclosure and risky sexual outcomes.~   "
110887|NCT02116036|"~     The antiphospholipid antibody syndrome (APS) is a syndrome associated with excessive blood~     clotting (thrombosis). APS is among the most common cause of heart attack and stroke in~     patients under the age of 50 and is particularly prevalent in patients with autoimmune~     conditions. Patients with APS and prior thrombosis require lifelong anticoagulant therapy to~     prevent recurrent clots; such therapy is currently provided with warfarin. Warfarin requires~     frequent bloodwork monitoring, and many medications or foods can alter its effect, which can~     put people either at increased risk for clotting or bleeding. Rivaroxaban is a new mediation~     that prevents blood clots that does not require bloodwork monitoring and that has fewer~     interactions. This study is a pilot feasibility study which will: 1) examine our ability to~     identify 150 eligible APS patients; 2) measure our ability to obtain consent from 135 of~     these patients; and 3) test our hypothesis that we can obtain 95% compliance with daily~     rivaroxaban administration. The investigators propose to treat eligible patients with~     rivaroxaban 20 mg once daily. Patients will be followed for a minimum of one year and their~     rates of bleeding and thrombosis will be monitored as secondary outcome measures.~   "
110888|NCT02116023|"~     The study is a human dietary test meal study that is a randomized, controlled, double blind,~     cross over design with 3 intervention arms that will investigate the subjective ratings of~     satiety in response to different levels of processed whole orange compared with a~     sugar-matched isocaloric control~   "
110889|NCT02116010|"~     The objective of PHAGOBURN is to assess tolerance and efficacy of local bacteriophage~     treatment of E. coli or P. aeruginosa wound infections in burned patients.~   "
110890|NCT02115997|"~     This is a perspective, Phase IV, multi-center, single arm, open-label, interventional study~     in adult participants with Wegener's granulomatosis (granulomatosis with polyangiitis [GPA])~     or microscopic polyangiitis. Participants will be treated with rituximab (Ristova) and~     glucocorticoids. Rituximab will be administered by intravenous (IV) infusion at a dose of 375~     milligrams per meter square (mg/m^2) body surface area once weekly during Weeks 1 to 4.~     Participants will also receive one or three pulses of methylprednisolone (1000 milligram [mg]~     each), followed by a tapering dose of oral prednisolone (start dose of 1 mg per kilogram per~     day). The dose of oral prednisone will be reduced as per evaluation by the investigator till~     the participant is completely off the drug. The participants will be followed up for duration~     of 6 months from the date of starting rituximab therapy with three follow-up visits at Days~     52, 112 and 172. All adverse events occurring during this period will be captured.~   "
110891|NCT02115984|"~     The goal of this trial is to assess the safety, therapeutic dose, and leukostimulatory~     activity of the preparation Panagen in the therapeutic schemes for treating cancer diseases~     in the patients receiving a standard chemotherapy for breast cancer of stages II-IV (with~     distant metastases).~   "
110892|NCT02115971|"~     The aim of this pilot study is to analyze the effect of a 12-week specific jump training~     compared with conventional therapy in patients with chronic functional instability of the~     ankle. It is to be evaluated to what extent the symptoms in of chronic functional instability~     of the ankle can be influenced in everyday life.~   "
110922|NCT02115581|"~     This study aims to determine the effect of Coenzyme Q10 supplementation on conventional~     therapy of children with heart failure due to idiopathic dilated cardiomyopathy.~   "
110923|NCT02115568|"~     This is an exploratory registry that will include subjects who have been randomized to~     receive JVS-100 treatment (at one of multiple doses) or placebo by one of a number of~     delivery systems (e.g. endomyocardial injection, retrograde infusion) in a previous Juventas~     clinical trial.~   "
110893|NCT02115958|"~     Most studies of cancer stem cells (CSC) involve the inoculation of cells from human tumors~     into immunosuppressed mice, preventing an assessment on the immunologic interactions and~     effects of CSCs. In this study, the investigators examined the vaccination effects produced~     by CSC-enriched populations from histologically distinct murine tumors after their~     inoculation into different syngeneic immunocompetent hosts. Enriched CSCs were immunogenic~     and more effective as an antigen source than unselected tumor cells in inducing protective~     antitumor immunity.Immune sera from CSC-vaccinated hosts contained high levels of IgG which~     bound to CSCs, resulting in CSC lysis in the presence of complement.CTLs generated from~     peripheral blood mononuclear cells or splenocytes harvested from CSC-vaccinated hosts were~     capable of killing CSCs in vitro. Mechanistic investigations established that CSC-primed~     antibodies and T cells were capable of selective targeting CSCs and conferring antitumor~     immunity.~   "
110894|NCT02115945|"~     Total knee prosthetic replacement causes severe postoperative pain. Various analgesic~     techniques have been used in pain control. Comparison of epidural and femoral nerve block is~     lacking, furthermore effect on chronic pain is unclear. The investigators aimed to compare~     the effects of epidural and femoral block on acute and chronic postoperative pain.~   "
110895|NCT02115932|"~     People with diabetes can have nerve damage in their extremities (peripheral neuropathy), and~     this can lead them to being less able to maintain their balance when they are standing,~     walking or performing complex movement tasks in their day-to-day life. This results in them~     being more prone to falls, and consequent injuries. The purpose of this study is to determine~     whether providing strength and balance retraining (in the form of specific physical exercises~     or activities) can help people with diabetic peripheral neuropathy regain their ability to~     maintain their balance, increase their confidence in performing balance-based activities and~     improve their quality of life.~   "
110896|NCT02115919|"~     Caused by the human papillomavirus (HPV), anogenital warts are a common sexually-transmitted~     infection (STI). They are distressing to those who have them and are a source of viral~     shedding and transmission to others. Treatment of warts is aimed at destruction of the~     lesion.~      Objectives:~        1. Establish safety of Multikine in treatment of perianal condyloma.~        2. Describe presence of anal HPV and anal dysplasia in participants with perianal~          condyloma.~        3. Describe adverse effects associated with Multikine in the management of perianal~          condyloma.~      Design:~      Phase I, dose-escalation trial. Potential participants desiring treatment for their perianal~     warts will be referred to study by their primary clinician. All participants will undergo~     baseline anal Pap, anal HPV subtyping, perianal condyloma characterization (count,~     measurement, photography), and complete a baseline questionnaire. Cohort A participants will~     undergo perilesional Multikine injections (200IU) once daily, Monday through Friday, for 14~     days, off for 14 days, then again once daily, Monday through Friday for 14 days. If no~     serious adverse events are noted after 4 weeks of therapy, cohort B will be studied using the~     same schedule but with a dose of 400IU per treatment. Each participant will undergo anal Pap~     and anal HPV subtyping once weekly during treatment. Condyloma characterization (count,~     measurement, photography) will occur prior to each treatment. After treatment completed,~     participants will complete a follow-up visit at 70, 100, 130, 160 days and have anal Pap,~     anal HPV subtyping, and perianal condyloma characterization (count, measurement, photography)~     performed.~      Subjects:~      The study will be open to adult men and women who are HIV-infected who receive medical care~     from the Naval Medical Center San Diego.~      Main Outcome Measures:~        1. Perianal wart characterization [count, measurement (in millimeters diameter)],~          photography)~        2. HPV subtype in anal canal~        3. Anal dysplasia cytologic grade~        4. Questionnaire responses~        5. Adverse effects experienced during treatment, recorded in symptom log~   "
110897|NCT02115906|"~     Growth hormone (GH) plays a pivotal role in the regulation of body composition including~     ectopic lipid deposition in insulin sensitive organs like liver and skeletal muscle. Recent~     evidence indicates that the GH-IGF1 axis affects body composition via regulating~     mitochondrial oxidation capacity.~      Thus, excessive GH secretion by a pituitary adenoma (Acromegaly) might be accompanied by~     increased mitochondrial activity leading to inappropriately low intracellular lipid depots,~     especially in metabolically active tissue like liver and skeletal muscle.~      This study aims to assess metabolic activity and intracellular lipid content in skeletal~     muscle and liver in patients suffering from acromegaly compared to controls by 31P/1H~     Magnetic resonance spectroscopy before and in follow up examinations 3, 6 and 12 months after~     initiation of GH lowering treatments including surgery, somatostatinanalogs or pegvisomant,~     as well as oral glucose tolerance tests at each examination to assess treatment responses and~     calculate validated parameters for insulin sensitivity and resistance.~   "
110898|NCT02115893|"~     The main aim of the current study will be to find the optimal duration of supplementation to~     enhance sports performance.~   "
110899|NCT02115880|"~     The purpose of this randomised controlled trial is to see whether a group-based psychological~     intervention for families can reduce the inflated risk of depression in children and~     adolescents who have at least one parent who suffers from depression (or who has suffered~     from depressed in the child's lifetime).~   "
110900|NCT02115867|"~     Diverticulitis is an extremely common digestive disease particularly found in the large~     intestine in elderly patients and develops from diverticulosis. Diverticulosis is~     characterized by the formation of pouches (diverticula) that bulge to the outside of the~     colon, through areas of weakness in the colonic wall. Inflammation (diverticulitis) results~     if one of these diverticula becomes infected and / or obstructed. It is commonly accompanied~     by obvious or microscopic perforation, ranging in severity from a single, mild, acute attack~     of diverticulitis to more severe attacks characterized by abscess formation, occasionally~     resulting in chronic complications such as obstruction and fistula formation. After an~     episode of diverticulitis many patients develop changes in bowel openings, from diarrhoea and~     constipation, and many patients have abdominal pain and a symptom complex that resembles~     Irritable Bowel Syndrome (IBS).~      According to available guidelines, treatment of symptomatic, but uncomplicated, diverticular~     disease aims to reduce the frequency and severity of diverticular related symptoms (abdominal~     pain, bloating, alterations in bowel habit) and to prevent complications. Different agents~     have been proposed, such as bulking agents, antispasmodics, and nonabsorbed topical~     antibiotics, 5amino acid preparations but these measures are unproven or controversial. It is~     thought that intestinal bacteria may play a significant role in the symptoms of~     post-diverticulitis.~      The investigators have recently shown that a probiotic (Symprove) reduced the symptoms of IBS~     significantly in comparison with a placebo in a double-blind randomized trial and without~     side effects (paper in preparation). Because the symptoms in IBS and post-diverticulitis are~     so similar the investigators propose a double-blind placebo controlled trial of Symprove in~     patients with problematic diverticulitis. Patients will be recruited from a dedicated~     diverticulitis clinic using standard exclusion criteria. This is a 90 day symptom based trial~     using accepted outcome measures. If successful the results will have widespread implications~     for treatment of diverticular disease.~   "
110901|NCT02115854|"~     The distinction between Tuberculosis disease (TB), a worldwide infective granulomatosis~     requiring long-term antibiotic treatment, and sarcoïdosis, a rare granulomatous disease~     successfully treated with high dose steroids is not straightforward and may delay the~     treatment choice by the physician.~      The goal was to evaluate prospectively and consecutively the presence of epithelioid~     granulomas in salivary glands biopsy of patients with TB.~   "
110924|NCT02115555|"~     The study will compare three treatment strategies to look at the best clinical outcomes.~      The investigator hypothesizes that the combined approach of a health information technology~     program plus a conflict-management contract will lead to the best outcomes.~   "
110902|NCT02115841|"~     Noninvasive brain stimulation was recently gradually be emphasized. The electrical current~     applied on scalp can effective modulate cortical excitability. Forms of Stimulation included~     transcranial direct current stimulation(tDCS) and transcranial alternating stimulation(tACS).~     tDCS had been proved the effect of cortical excitability modulation. The polarization effect~     of direct current stimulation can modulation specific brain area and enhance motor~     performance. tACS was still controversial about the effect on cortical excitability. Previous~     study show that the frequency dependent excitatory or inhibitory effect on cortex. The~     possible mechanism was to affect brain oscillation status by provided different frequency of~     stimulation. Transcutaneous nerve stimulation (TENS) was common used on management of chronic~     pain. Peripheral nerve stimulation can enhance pain or sensory evoked potential was noted.~     Effect of low frequency TENS on central nervous is unknown.~   "
110903|NCT02115828|"~     This is a single-arm pharmacodynamic study with mandatory metastatic tumor biopsies in men~     with castration-resistant prostate cancer.~      The trial will evaluate the effect of vismodegib on tumor tissue in men with metastatic CRPC~     by obtaining tumor biopsies at baseline and after 4 weeks of treatment with vismodegib.~   "
110904|NCT02115815|"~     The purpose of this study is to determine if the administration of single ascending~     intramuscular doses of the RSV sF antigen or MEDI7510 will be safe and well tolerated in~     adults 60 years or older who are healthy or who have stable, chronic underlying medical~     conditions.~   "
110905|NCT02115802|"~     The purpose of this study is to record electrical brain activity during DBS surgery and after~     DBS surgery using the Medtronic Activa PC+S deep brain stimulation (DBS) system, a modified~     DBS pulse generator. The goal of the study is to investigate if the electrical brain activity~     can help customize DBS therapy.~   "
110906|NCT02115789|"~     Surgical wounds can be closed in several manners. Some physicians believe that closure in a~     straight line produces a scar that is more visible and slightly raised when compared to~     closure in a zigzagging fashion. The researchers of this study believe that there is no~     difference in the cosmetic appearance of one type of wound closure over the other. To~     evaluate this, they will provide a survey with visual aids to volunteers to rate the~     appearance of a straight line scar versus a zigzag scar.~   "
110907|NCT02115776|"~     The aim of this study is to evaluate the efficacy of prophylactic dosage with amoxicillin~     (AMX), amoxicillin-clavulanate (AMX-CLV), and a combination of amoxicillin-clavulanate and a~     chlorhexidine mouthwash (AMX-CLV-CHX) in the prevention of bacteremia following dental~     extractions.~      The study hypothesis is that an antimicrobial regimen with amoxicillin-clavulanate will show~     higher effectiveness in reducing the prevalence and duration of bacteremia following dental~     extractions, than that achieved with the classical amoxicillin regimen.~   "
110908|NCT02115763|"~     Caffeine has been shown to consistently improve time-trial performance, warranting~     restrictions on consumption under regulation of the National Collegiate Athletics Association~     (NCAA) and World Anti-Doping Agency (WADA). This ergogenic effect is not well understood,~     possibly occurring as a result of altered metabolism, improved strength, and/or reduced~     muscle pain. The hypothesis of altered metabolism has recently fallen out of favor while~     muscular strength has a tenuous relationship with endurance exercise performance. Reductions~     in muscle pain have been observed during low and moderate intensity endurance exercise, and~     this may be the mechanism of caffeine's ergogenic effect. In lieu of reducing pain during~     high intensity exercise, caffeine significantly improves performance. Therefore, caffeine~     appears to improve the amount of work that can be done for a given muscle pain rating,~     suggesting that participants may pace based upon sensations of muscle pain during endurance~     exercise. Most time-trial exercise is conducted in a fixed distance manner, measuring the~     time it takes participants to cover a given distance. Little research has been conducted on a~     fixed pain time-trial that would require participants to produce and sustain a given level of~     muscle pain while measuring the distance covered in an allotted time. A fixed pain time-trial~     could allow researchers to better understand the effect of pain on endurance performance. The~     purpose of this study is to examine the effects of caffeine on a fixed pain time-trial.~   "
110909|NCT02115750|"~     This is a two part study comparing CHS-0214 to Enbrel in patients with active rheumatoid~     arthritis and an inadequate response with Methotrexate (MTX) who are naive to biologic~     therapies.~      Pt.1 is a 24-week randomized, double-blind, active-control, parallel-group, multi-center~     global study. The primary end point is 20% improvement in American College of Rheumatology~     criteria (ACR-20) at week 24. Comparing CHS-0214 to Enbrel for efficacy and safety.~      Pt. 2 is an open-label single arm study in which patients with at least an ACR-20 response~     receive CHS-0214. Continued response and safety will be evaluated.~   "
110910|NCT02115737|"~     Youth with depressive symptoms are at risk for a range of problems later in life. This~     includes problematic interpersonal relationships, occupational stress, and the occurrence of~     adult mental disorders. The main purpose of this study is to test how effective two types of~     group therapy are at reducing depressive symptoms in youth. A focus on group therapy is~     important because group therapy allows for many youth to be treated in a short amount of~     time. Group therapy is also helpful because youth can get social support and feel less alone~     in their symptoms when they participate in group. This study compares two groups, one that~     targets skills for managing difficult emotional experiences (dialectical behavior therapy~     skills group) and another group focuses on psychoeducation and is based on a publicly~     available treatment manual from the Services for Teens At Risk (STAR) Center at the~     University of Pittsburgh. The results of this study will provide insights regarding the~     comparative efficacy of these two treatments, and regarding predictors of treatment response.~   "
110911|NCT02115724|"~     Cardiovascular disease is the leading cause of death in the United States. Other studies have~     shown that stress, early in life, could be a risk factor for cardiovascular disease, later in~     life. This study will look at the effect of early life stressors on your cardiovascular~     health.~   "
110925|NCT02115542|"~     The main purpose of this study is to see if regorafenib can help control or decrease cancer~     size in patients with cancer of the bile duct. Researchers also want to find out if~     regorafenib is safe and tolerable.~   "
111793|NCT02104141|"~     The purpose of this combination retrospective and prospective post market study is to examine~     the short term safety and efficacy of the ROI-A® interbody fusion device with VerteBRIDGE®~     plates to treat single and two-level degenerative disc disease between L2 and S1, with a~     focus on fusion rates and patient outcomes.~   "
110912|NCT02115711|"~     The study is a 2 year community based cluster randomized controlled trial to assess the role~     that a community health worker led intervention, in concert with physician education, can~     play in controlling the principal cardiovascular risk factors, i.e. hypertension, tobacco~     use, diabetes mellitus, physical inactivity and an unhealthy diet. Participants will include~     around 3600 adults, 35-70 years of age, from the urban community in the town of Dalkhola,~     Uttar Dinajpur district, West Bengal, India. The hypothesis of the study is that a community~     health worker based approach can result in increased control of Hypertension, Diabetes and~     Smoking.~   "
110913|NCT02115698|"~     Up to 66 healthy elderly individuals (at least 65 years old) are recruited as subjects. They~     will be recruited as a subgroup to protocol ID: H-4-2013-070.~      Upon inclusion, each individual will be randomized into one of the five groups stratified~     according to gender (M/F) and 30s chair stand (<16 OR ≥16). The five groups are: Heavy~     Resistance Training (N=12), Light Intensity Training (N=12), Protein Whey (N=15), Protein~     Collagen (N=15) and Carbohydrate (N=12). The individuals randomized into one of the~     supplementation groups (Protein Whey, Protein Collagen or Carbohydrate) will be blinded to~     the supplement content.~      Assessments will be performed at Baseline (before intervention start) and after 12 months of~     intervention.~      The primary outcomes are measures of muscle protein synthesis rate measured as the fractional~     synthesis rate from Baseline to 12 months of intervention.~      The hypotheses are i) that basal and protein-stimulated muscle protein synthesis rates are~     elevated in the exercise training groups after 12 months of intervention. ii) prolonged~     intake of protein of different quality will improve the muscle protein synthetic response to~     protein intake after 12 months of intervention.~   "
110914|NCT02115685|"~     Significance: The long term objective of this study is to improve physical therapy and~     fitness programs in people with spinal cord injury. The results of the study will demonstrate~     the importance of matching blood flow to a muscle with exercise of that same muscle.~      Scientific Objective: The objective of the study is to measure how the body regulates~     bloodflow to a muscle during exercise. We intend to study these effects by triggering blood~     flow changes during movement, and measuring bloodflow changes during exercise in people with~     spinal cord injury. We will also look at the long term effects of different exercise programs~     on bloodflow during exercise.~      Study Populations: This study will involve people with partial spinal cord injury and age and~     sex matched controls without injury.~      Specific Aims: Aim 1 will be to measure bloodflow during exercise of the legs (below the~     injury). This aim will examine the control of bloodflow and muscle contractions and how it~     changes after spinal cord injury. Aim 2 will then look at changes in bloodflow during~     exercise after training. Three different eight week exercise training programs will be tested~     including 1) upper body ergometry, 2) treadmill training with exertion level matched to the~     upper body ergometry and 3) treadmill training with heart rate matched to an initial test of~     upper body ergometry.~   "
110915|NCT02115672|"~     The aim of the study is to test the safety and efficacy of BL-8040 (a CXCR4 antagonist) in~     improving the response to imatinib in CML patients not achieving an optimal response with~     imatinib alone.~   "
110916|NCT02115659|"~     Triptolide was shown in experimental studies to inhibit the cyst formation and growth in~     ADPKD models, while triptolide-containing formulation was revealed to potentially slow the~     disease progression in several proteinuric ADPKD patients in our clinical practice. It~     remains to be shown the effect of triptolide-containing formulation on total kidney volume~     (TKV) enlargement and renal function protection in ADPKD patients.~   "
110917|NCT02115646|"~     The investigators are studying the appearance and function of burn scars after treatment with~     fractionated carbon dioxide laser. The investigators hypothesize that the cosmetic appearance~     and range of motion will improve with treatment.~   "
110918|NCT02115633|"~     The overall goal of this project is to continue development and commercialization of a~     Wearable Sensory Prosthesis termed Walkasins. The device measures foot pressure through a~     thin sole insert, developed under NIA SBIR Phase I funding, and displays pressure information~     through a vibrotactile feedback array, placed around the lower leg, to help improve balance~     function. The device can replace lost foot pressure sensation in individuals with peripheral~     neuropathy who have balance problems.~   "
110919|NCT02115620|"~     The purpose of this study is to see if telemedicine can help improve the health of patients~     with heart failure who have recently been hospitalized with heart problems, and are being~     discharged to a Skilled Nursing Facility. Telemedicine uses electronic communications to make~     patient/doctor visits possible from a distance.~      This study will use remote video to allow heart failure specialists at Providence St. Vincent~     Medical Center to provide clinical health care to patients at Marquis Hills. Electronic~     monitors (including an electronic scale and blood pressure machine), and phone calls with the~     Marquis Hill nursing staff will be used to track patients' health status. The nursing staff~     will provide the heart failure specialists with daily updates on patients' symptoms, weight,~     vital signs (heart rate, blood pressure, pulse), and results of blood tests.~      Additionally, some patients will be provided with monitoring devices that include an iPhone~     blood pressure monitor, and Smart Body Analyzer to use for 14 days. The Smart Body Analyzer~     measures weight, body fat percentage, and heart rate. It also measures indoor air quality.~     Special software on the iPhone will save this information and the information will be~     transmitted by secure email to the study doctors.~      Hypothesis: The patients followed by telemedicine will have fewer visits to the Emergency~     Department, fewer deaths, and fewer hospital re-admissions than last year's site-specific~     average for this patient population.~   "
110920|NCT02115607|"~     This is a diagnostic accuracy study to evaluate if two novel ultrasound (US) techniques,~     quantitative 3D subharmonic imaging (SHI) and Subharmonic Aided Pressure Estimation (SHAPE),~     used with an intravenous ultrasound contrast agent (Definity, Lantheus Medical Imaging,~     Billerica, MA), can track changes in locally advanced breast cancer (LABC) angiogenesis and~     interstitial fluid pressure (IFP), respectively, by studying women undergoing neoadjuvant~     chemotherapy before as well as with around 10% and 60% (in part 1) or 30% (in part 2) of the~     neoadjuvant chemotherapy treatment delivered and after completion of the neoadjuvant~     chemotherapy treatment. Results will be compared to MRI and pathology.~   "
110938|NCT02115373|"~     This is a Phase 1b/2, multicenter, single arm trial to assess the efficacy, safety, and~     pharmacokinetics (PK) of MSC2156119J as monotherapy in subjects with MET+ advanced~     hepatocellular carcinoma (HCC) with child Pugh Class A liver function who have failed~     sorafenib treatment.~   "
110926|NCT02115529|"~     Untreated, one third of patients undergoing general anesthesia will have postoperative~     nausea, vomiting, or both.~      Patients often rate postoperative nausea and vomiting (PONV) as worse than postoperative~     pain. PONV increases the risk of aspiration and has been associated with suture dehiscence,~     esophageal rupture, subcutaneous emphysema, and bilateral pneumothoraxes. PONV frequently~     delays discharge, and is the leading cause of unexpected hospital admission after planned~     ambulatory surgery.~      Nabilone (Cesamet®) is a synthetic cannabinoid developed in the 1970s which is a potent CB1~     agonist. The use of nabilone in preventing nausea and vomiting in patients receiving~     chemotherapy has been thoroughly investigated. Results from clinical studies demonstrated the~     efficacy, safety, and tolerability of Cesamet in this population. There has been success in~     the past translating treatments for chemotherapy-induced nausea and vomiting (ie. 5-HT~     receptor agonists including Ondansetron and Granisetron) to use in the perioperative~     environment.~      Only one RCT has studied the use of nabilone for the reduction of PONV. Published in 1995,~     this study compared the administration of either Cesamet 2 mg or metoclopramide 10 mg given~     90 minutes before the operation in patients scheduled for elective hysterectomy in 60 women.~     This study failed to show any significant difference between groups. There are several~     limitations to this study including a poorly optimized dosing regimen, a small sample size,~     and a comparison group lacking clinical generalizability.~      This study will investigate the use Cesamet vs Placebo, in addition to the regular antiemetic~     treatment which patients receive at the discretion of the managing anesthesiologist, for the~     prevention of PONV. The study group will include patients undergoing general anesthesia for~     elective ambulatory surgery with at least 3 risk factors (>60% risk) for the development of~     PONV.~   "
110927|NCT02115516|"~     TÜCHMI-002 is a single center, randomized, placebo-controlled, double-blinded, PfSPZ~     Challenge dose finding trial with two chemoprophylactic regimens and subsequent controlled~     human malaria infection (CHMI).~   "
110928|NCT02115503|"~     The purpose of this treatment registry study is to determine if monthly infusions of~     Intravenous Immunoglobulin (IVIg) for 6 months will neutralize donor specific antibodies that~     are thought to be responsible for chronic rejection episodes in renal transplant subjects.~     162 renal transplant subjects will receive IVIg 5% at 2gm/kg/month for 6 months and be~     followed for 3 years.~   "
110929|NCT02115490|"~     Osteoporosis is a public health problem. It is a skeletal disease being treated by~     Bisphosphonates as the first choice medication. The effects of these drugs were investigated~     for periodontal disease treatment both locally and systemically. However, it is very~     important to know their indirect effects on alveolar bone (i.e. their effects when used for~     treating osteoporosis). So, in this study, alternations that involve the alveolar bone when~     osteoporotic women use bisphosphonates will be studied radiologically using cone-beam CT and~     digital panoramic radiography. The goal is to provide dentists with information about changes~     in the characterization of the alveolar bone among these women. This is important for both~     periodontology and implantology. Maxillary and mandibular bone structural characterization~     among osteoporotic women had not been studied before. Furthermore, in an opposite direction,~     dental radiographs may aid in detecting osteoporosis.~      Osteoporotic women, under bisphosphonates therapy or not, will be invited to participate in~     this study. In addition, osteopenic and normal women regarding bone fragility will be~     included too, for comparison purposes. Panoramic radiographs will be taken. In addition,~     women under bisphosphonates for 6 months or more will be scanned by Cone -beam CT as it can~     give an idea about bone histomorphometry with a low radiation dose.~   "
110930|NCT02115477|"~     The purposes of this study are~        -  to determine the prevalence, size and impact on quality of life of lymphedema of the~          lower extremities after primary radical surgery with hysterectomy +/- pelvic - and~          paraaortic lymphadenectomy in women with endometrial uterine carcinoma FIGO~          (International Federation of Gynecology and Obstetrics) stage 1 and 2~        -  to analyze risk factors for development of lymphedema in this specific group of~          patients.~      Our hypotheses are that women who have lymphadenectomy more often suffer from lymphedema,~     subjectively and objectively, and have an impaired quality of life.~      This is a Swedish multicenter study carried out in 17 departments of Obstetrics and~     Gynecology and in 3 departments of Oncology. All participants are treated according to the~     Swedish National Guidelines for Endometrial Cancer.~      130 women with endometrial cancer who have a hysterectomy with lymphadenectomy (high-risk~     endometrial carcinomas) and 130 women with endometrial cancer who have a hysterectomy without~     lymphadenectomy (low-risk endometrial carcinomas) are prospectively enrolled in the study.~      The participants are examined preoperatively and on 3 occasions postoperatively, i.e. 4-6~     weeks , 6 months and 12 months postoperatively.~      Determination of occurrence of lymphedema of the lower extremities are determined objectively~     by 1) a standardized clinical evaluation according to Bruna et al.[1] and 2) determining the~     leg volume according to the cone model by Sitzia [2] by systematically measuring of leg~     circumferences. In addition, occurrence of lymphedema is measured subjectively by the~     participants.~      On the same four occasions as the leg circumference measurements are conducted the patients~     complete two generic health related quality of life forms (the EuroQol EQ-5D and the~     Short-Form 36 SF-36) and the condition specific quality of life form for limb lymphedema~     (LYMQOL).~      Demographic and clinical data are systematically collected until one year postoperatively~     including occurrence of complications and given adjuvant oncological therapy such as chemo-~     and radiation therapy.~      On each occasion of clinical control a vaginal ultrasound examination is carried out in order~     to register pelvic and abdominal lymphocele formation or lymphatic fluid effusion~     intraabdominally.~   "
110931|NCT02115464|"~     ALMERA is a randomized, phase II, open label study in patients with locally advanced~     non-small cell lung cancer (NSCLC) which will compare standard radiotherapy plus concurrent~     chemotherapy with or without consolidation versus the same treatment plus concurrent~     Metformin continuing for 12 months. Metformin is a well tolerated and inexpensive drug that~     has the potential to improve cancer patient outcomes.~   "
110932|NCT02115451|"~     The aim of this study is to evaluate knee function, sports participation and knee reinjuries~     over 2 years in a group of patients who choose either nonsurgical or surgical treatment for~     an anterior cruciate ligament (ACL) injury~   "
110933|NCT02115438|"~     Occupation stress can be the risk factors of early embryonic death~   "
110934|NCT02115425|"~     The purpose of this study is to collect body composition data using bioimpedance analysis~     (Samsung) and DXA (GE Medical). Both of the methods are explained in more detail in section 5~     of this consent. The data collected will help Samsung improve the products the company~     offers.~   "
110935|NCT02115412|"~     Research has shown that nearly 50% of patients with chronic conditions around the globe do~     not adhere to their prescribed medicine, leading to enormous cost to the healthcare~     providers. Non-adherence can be due to various forms and have multiple causes.~      To address this need, Philips Research has developed Medication Non-adherence model. This~     tool will help in developing a systemic way of assessing medication non-adherence and~     providing decision support for targeted intervention to healthcare professionals. The aim of~     this study is to validate this model with 750 chronically ill patients in UK.~   "
110936|NCT02115399|"~     The purpose of this study is to look at how defects in the skin barrier and immune response~     affect risk for skin infections.~      Participants will be classified into 4 groups based on Atopic Dermatitis (AD)/Non-Atopic (NA)~     status and Staphylococcus aureus (S. aureus) colonization (negative or positive):~        -  AD S. aureus negative~        -  AD S. aureus positive~        -  NA S. aureus negative and~        -  NA S. aureus positive.~   "
110937|NCT02115386|"~     Primary Objective for this study is to evaluate changes in chronic low grade~     non-hematological adverse events experienced by patients who have been treated with at least~     6 months of imatinib and who have not responded to supportive measures, when they are~     switched to nilotinib (CTCAE grading system).~   "
110940|NCT02115347|"~     This is a study to assess the pharmacokinetics and safety of ertugliflozin (MK-8835,~     PF-04971729) in participants with hepatic impairment versus healthy participants. In Part 1~     of the study, participants with moderate hepatic impairment (Child-Pugh score 7-9) and~     matched healthy participants will be enrolled; depending on results in Part 1, Part 2 may be~     conducted and will enroll participants with mild hepatic impairment (Child-Pugh score 5-6).~   "
110941|NCT02115334|"~     Early intervention refers to the provision of early detection, early diagnosis, and early~     intervention for infants and young children with special needs. The implementation of home~     programs is very important for children with developmental delay (DD). Therefore, the~     purposes of this study are to: (1) design the preschool home program activities(PHPA), (2)~     investigate the immediate efficacy of PHPA for children with DD, (3) investigate the~     long-term efficacy of PHPA for children with DD.The second year is to investigate the~     immediate efficacy of PHPA for children with DD.~   "
110942|NCT02115321|"~     This study is being done to evaluate the efficacy and safety of the drug combination~     grazoprevir (GZR; MK-5172) + elbasvir (EBR; MK-8742) in participants with chronic hepatitis C~     virus (HCV) genotype (GT) 1, 4, or 6 infection and who have cirrhosis and Child-Pugh (CP)~     score 7-9 moderate hepatic insufficiency (CP-B). The primary hypothesis is that the~     percentage of HCV-infected participants with hepatic insufficiency (the CP-B population)~     achieving sustained viral response (SVR) 12 weeks after the end of all treatment (SVR12) will~     be greater than 60%. Additionally, ten non-cirrhotic (NC) HCV-infected GT1 participants will~     also be given GZR + EBR at the beginning of the study; this will be done for the purpose of~     collecting plasma pharmacokinetic (PK) data in HCV GT1-infected participants who do not have~     hepatic insufficiency.~   "
110943|NCT02115308|"~     The purpose of this study is to measure the changes in cardiac function during a Lexiscan~     pharmacologic stress test using cardiac magnetic resonance imaging test.~   "
110944|NCT02115295|"~     The goal of this clinical research study is to learn if the combination of cladribine,~     idarubicin, and cytarabine can help to control AML, high risk MDS, and/or CML in blast phase.~     The safety of these drugs will also be studied.~   "
110945|NCT02115282|"~     This randomized phase III trial studies exemestane and entinostat to see how well they work~     compared to exemestane alone in treating patients with hormone receptor-positive breast~     cancer that has spread to nearby tissue or lymph nodes or another place in the body. Estrogen~     can cause the growth of breast cancer cells. Endocrine therapy using exemestane may fight~     breast cancer by lowering the amount of estrogen the body makes. Entinostat may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet~     known whether exemestane is more effective with or without entinostat in treating breast~     cancer.~   "
110946|NCT02115269|"~     Headaches are a common medical problem that physicians frequently encounter in their~     practice. One of key findings of The Atlas of Headache Disorders prepared by World Health~     Organization (WHO) is: headache disorders, including migraine and tension-type headache~     (TTH), are among the most prevalent disorders of mankind. The fixed combination of~     indomethacin, prochlorperazine and caffeine (IndoProCaf) showed efficacy and safety in acute~     treatment of migraine and episodic tension-type headache attacks. IndoProCaf (Difmetre®) is~     widely used in common daily practice only in Italy from early 1970s, is available at the~     Commonwealth of Independent States (CIS) pharmaceutical market now. There are limited data~     regarding IndoProCaf usage from post-marketing settings. This will be a first post-marketing~     observational study which aimed to evaluate the effectiveness and patients' satisfaction of~     primary headaches acute treatment in routine clinical settings in Ukraine and Kazakhstan.~   "
110947|NCT02115256|"~     Breech presentation of a term pregnancy is a common occurrence. A procedure known as external~     cephalic version (ECV) is frequently used by obstetricians to turn the baby into the vertex~     position prior to delivery in order to avoid a cesarean section and the associated risks.~     Medications to relax the uterus, known as tocolytics, are used in conjunction with the~     procedure as they have been shown to improve the success rate of ECV, but with inconsistent,~     varying results.~   "
110948|NCT02115243|"~     The purpose of this study is to determine safety profile, initial response rates and~     progression free survival for the combination therapy of neoadjuvant system ipilimumab~     followed by ILI with melphalan in patients with in transit melanoma.~      Hypothesis:~      The combination of regional LPAm plus systemic ipilimumab will lead to a larger response rate~     than either therapy alone.~      The combination of regional LPAm plus systemic ipilimumab will cause larger changes in immune~     cell populations than are seen with either therapy along.~      Changes in immune cell populations will predict progression free survival.~   "
110949|NCT02115230|"~     It is a randomized prospective controlled study of transcatheter renal denervation in~     patients with Heart Failure With Normal LV Ejection Fraction. The purpose of the study is to~     evaluate the safety and effectiveness of renal denervation in patients with Heart Failure~     With Normal LV Ejection Fraction, due to reduction in renal and systemic sympathetic~     activity.~   "
110950|NCT02115217|"~     Ankles sprains are the most popular injuries in basketball players. They are traumatic~     injuries, which happen most of the time in specific situations, like landing on another~     player's foot, or during changes of direction.~      Neuromuscular exercises are very important to improve ankle stability and reduce risks of~     sprains. However various external support such as ankles braces and rigid tape, are also used~     in order to prevent injury.~      The kinesiotape (KT) is a new but broadly used method in the world of athletes. Created by~     KenzoKase, in 1980, this kind of tape has a tremendous success with athletes and is today~     commonly used during practices and/or competitions. The main property of this tape is its~     elasticity, which is supposed to improve proprioception and, thus ankle stability, but these~     aspects have not been investigated yet.~   "
110951|NCT02115204|"~     Taxane-based adjuvant chemotherapy is standard in node-positive (N+) early breast cancer~     (BC). The magnitude of benefit in intermediate-risk N+ early BC is still unclear. West German~     Study Group and Arbeitsgemeinschaft Gynäkologische Onkologie (WSG-AGO) EC-Doc is a large~     trial evaluating modern sequential taxane-based chemotherapy in the subgroup with 1-3~     involved lymph nodes (LN).~   "
111862|NCT02103244|"~     An adjusted dosing algorithm for the dosing of the anticancer drug carboplatin has been~     developed, that accounts for high BMI, low serum creatinine values and maximal calculated~     renal function. The hypothesis is that this new dosing algorithm provides a more accurate and~     safe dose than dosing according to the old standard of care.~   "
110952|NCT02115191|"~     Urethrocutaneous fistulae (UCF) represent one of the most frequent causes of morbidity after~     urethroplasty. Hypospadias can be repaired using different surgical techniques, but~     regardless of technique, the incidence of UCF ranges between 10% and 40%. The surgical repair~     of UCF remains the treatment of choice, even if some patients need further operations because~     of recurrences. The cyanoacrylates have been used as skin suture substitutes, and some~     evidence suggests a beneficial effect when these adhesives are used as an adjuvant in the~     management of UCF.~   "
110953|NCT02115178|"~     Background and Goal of Study: Minimal dose of spinal hyperbaric bupivacaine is commonly~     performed for adult anorectal surgery. This kind of anaesthesia can cause sinus bradycardia~     and hypotension wich reason is body position, autonomic nervus system reaction, reflex~     reaction even with low levels of sensory block. However, neither the publication of minimal~     doses of spinal hyperbaric bupivacaine effects of haemodynamic modifications nor their~     accuracy was widely discussed. The aim of the study is to make a comparison of the~     haemodynamic modifications due to minimal dose of spinal hyperbaric bupivacaine for adult~     anorectal surgery in lithotomy or jack knife position of steering impedance device.~      Materials and Methods: Patients will be included which are over then 18 years old, who~     underwent anorectal surgery of the benign pathology, requiring spinal anaesthesia, were~     admitted in this clinical randomized study, hospitalized in Hospital of Lithuanian University~     of Health Sciences Kaunas Clinics and agree to participate to this study (written~     settlement). All patients were implicitly divided in to 4 groups by the position will be~     operating (lithotomy or jack knife position and by American Society of Anaesthesiologists~     (ASA) clas I-II and III-IV). Technique of anaesthesia were strictly standardized by protocol.~     All patients were premedicated with oral diazepam 5mg and diclofenac 100mg 60min before~     operation. After arrival in the operating theater peripheral vein 18 or 20G catheter was~     inserted, infusion therapy were started with crystalloid 5-7ml/kg/hour. Standard monitoring~     was used, including noninvasive arterial blood pressure (BP), electrocardiography (ECG),~     heart rate, peripheral oxygenation. Circulatory changes were recorded impedance device. 2~     single-neck sensors connected vertically on both sides of the neck just below the ears lobe.~     Another pair of sensors attached on both sides of the chest processus xiphoid axillary line~     level. Thorax allows a variable electrical current, it travels through the lowest resistance~     (blood-filled aorta) and resistance is measured. For each heart contraction during changes in~     blood volume and velocity. Accordingly, replacing the resistors obtained by impedance~     settings.~      Haemodynamic variables were recorded in patients in the use of impedance cardiograph:~        1. arrives in the operating room;~        2. seating on the operating table;~        3. following the puncture;~        4. 10 min after spinal puncture;~        5. was laid in lithotomy or jack knife position;~        6. in the beginning and the end of the operation;~        7. patient was placed in the bed.~      Each measurement was monitoring and recorded the following data( ar findings):~        -  Cardiac output (CO);~        -  Systemic vascular resistance (SVR);~        -  Systolic index (SI)~        -  Cardiac index (CI);~        -  Acceleration index (ACI);~        -  Heart rate (HR);~        -  Non-invasive systolic (SAP), diastolic (DAP) and mean (MAP) blood pressure;~        -  Peripheral oxygenation (SpO2); Patients were placed in the sitting position on the slab~          (operating table) back to the doctor. Dural puncture was made at L3-L4 or L4-L5 with 27G~          Tamanho spinal needle ( BBraun, Germany) by medial punction in aseptic condition, before~          the punction was injected lidocaine 1% subcutaneous. 0.5% 4mg of heavy bupivacaine and~          0.01% 10µg fentanyl were injected over 2 minutes after free flow of cerebrospinal fluid~          was obtained. After sitting for 10 minutes ( sensory block was checked by the dermatomes~          with the methods of cold sensitivity) patients were asked to lie in the position wich~          operation will be done (lithotomy or jack knife position).~      After 20 min. surgery was started. When anaesthesia was imperfect, 25-100µg of fentanyl was~     given IV. General anaesthesia will be give in case of failure . These cases will be value~     like a failure, patients will be exclude from the study.~      Clinically significant hypotension will be define as a mean arterial blood pressure and heart~     rate decrease of 20% below baseline values. Systolic arterial blood pressure will reduce to~     90mmHG limit, intravenous ephedrine 5-10 mg will be injected. If heart rate will reduce to 45~     bpm, bradycardia will be treated with atropine 0,5 mg IV.~   "
110954|NCT02115165|"~     Cabazitaxel is a new generation taxane with a high capacity for blood-brain barrier crossing~     and limited peripheral neuro-toxicity, two major potential advantages in patients with~     advanced NSGCTs.~      Cabazitaxel has a broader in vitro spectrum of activity than docetaxel. Taxanes have~     demonstrated activity in pre-treated GCTs and are now part of standard treatment, but~     cabazitaxel has not yet been tested in patients with NSGCT.~   "
110955|NCT02115152|"~     This randomized phase II trial compared pathologic response rates (pCR) of early breast~     cancer following neoadjuvant fluorouracil-epirubicin-cyclophosphamide(FEC) and~     capecitabine-epirubicin-cyclophosphamide (XEC).~   "
110956|NCT02115139|"~     Ipilimumab adds a clinical benefit to radiation therapy in patients with melanoma metastatic~     to the brain.~      Melanoma is the third most common cancer causing brain metastases, after cancers of the lung~     and breast, which appears to reflect the relative propensity of melanoma to metastasize to~     the central nervous system (CNS). Brain metastases are responsible for 20 to 54 percent of~     deaths in patients with melanoma, and among those with documented brain metastases, these~     lesions contribute to death in up to 95 percent of cases, with an estimated median overall~     survival ranging between 1.8 and 10.5 months, depending upon other prognostic factors.~      Ipilimumab is an anti-Cytotoxic T-Lymphocyte Antigen 4 (anti-CTLA4) monoclonal antibody that~     has demonstrated a clinically relevant and statistically significant improvement in overall~     survival, either alone (second line) or in combination with dacarbazine (DTIC) in 1st line.~      Ipilimumab has shown activity against brain metastases.~      According to the European Medicines Agency (EMA) approved label for Yervoy®, the use of~     glucocorticoids at baseline (commonly prescribed when brain metastases are diagnosed) should~     be avoided before the administration of ipilimumab. Data show that the use of even high doses~     of glucocorticoids for the management of immune-related adverse events do not decrease the~     efficacy of Yervoy®. There is no documented experience on the efficacy of Yervoy® when given~     concomitantly with radiation therapy and glucocorticoids.~      In experimental models, radiation therapy is synergistic to anti-Cytotoxic T-Lymphocyte~     Antigen 4 (anti-CTLA4) strategies (abscopal effect).~      There are no published results from clinical trials on the interaction between radiation~     therapy and ipilimumab.~   "
110957|NCT02115126|"~     This is a non-blinded, not placebo controlled, randomized, parallel phase 2 pilot study to~     evaluate the immunological response and the safety of Epstein Barr Virus (EBV)-derived tumor~     antigen, Latent Membrane Protein-2 (LMP2)-loaded dendritic cell (DC) vaccines alone or~     co-administered with the TLR9 ligand, DUK-CPG-001, in patients with EBV+ lymphoma in the~     setting of autologous stem cell transplant with infusion of mature T cells. Patients will be~     randomized to receive vaccine alone or vaccine co-administered with the TLR9 ligand,~     DUK-CPG-001. Randomization will be stratified by 2 disease types: Hodgkin lymphoma and~     non-Hodgkin lymphoma.~   "
110958|NCT02115113|"~     The purpose of this study is, starting from the Italian clinical practice in liver~     transplantation, to optimize the immunosuppressive therapy, considering specific patient~     characteristics as alcoholic cirrhosis, hepatitis C virus (HCV), hepatocellular carcinoma~     (HCC), and short/long-term implications. Then efficacy and safety of a calcineurin inhibitor~     (CNI)-withdrawal regimen will be evaluated in comparison with a CNI-minimization regimen.~   "
110959|NCT02115100|"~     Prospective, randomized, controlled, multicenter, international clinical trial. The study~     population consist of patients with paroxysmal or persistent atrial fibrillation with out~     range hypertension or signs of sympathetic overdrive. Patient will be randomized into one of~     the following two groups.~      group 1 : patients will undergo pulmonary vein isolation, group 2: Patients will undergo~     pulmonary vein isolation and renal artery denervation.~   "
110960|NCT02115087|"~     The aim of this study is to evaluate the effect of the ultrasound guided rectus sheath block~     (RSB) on both intraoperative sevoflurane consumption and postoperative analgesia.~   "
110961|NCT02115074|"~     Optico-chiasmatic gliomas have therapeutic feature since surgical resection plays a secondary~     role. Unlike other sites, many of these tumors are not amenable to complete resection either~     because of anatomical location, and sometimes they only can be biopsied. A substantial number~     of children will have recurrences following resection or will experience progression~     following incomplete tumor removal or biopsy.~      Celebrex is a Cox-2 inhibitor with anti-angiogenic and anti-tumor properties, while statins~     are known to increase the sensitivity of gliomas to anti-tumor agents. Their association~     could be administered for long periods, in the hope of much reduced risk of toxicities.~      This is a national, multicentric, interventional, open-label, non-comparative, and~     non-randomized phase I study evaluating the maximum tolerated dose of the Fluvastatin in~     combination with fixed-dose of Celebrex.~      This project involves 10 SFCE health centers accustomed to phase I / II studies(Société~     Française de Lutte contre les Cancers et Leucémies de l'Enfant et de l'Adolescent - French~     Society for the Fight against Cancer and Leukemia in Children and Adolescents).~   "
110962|NCT02115061|"~     The purpose of the spring is to maintain the cyanoacrylate polymer of the gastric varix,~     forming a conglomerate spring-cyanoacrylate, and thus preventing their migration to the~     adhesive embolism.~      The introduction of the spring is held by a echo-guided puncture. The window can be puncture~     through the distal esophagus or directly in the gastric varix via retroflexion to the fundus.~     Another advantage of this technique is its use in the presence of bleeding, when large~     amounts of blood in the stomach hinders the injection of the cyanoacrylate, by pricking the~     distal esophagus that difficulty decreases. The first study of this technique was performed~     by Binmoeller et al (21) and had good results with 100% hemostasis and low rebleeding rate~     (16%), but more studies are needed to prove the safety and efficacy of this technique.~   "
110963|NCT02115048|"~     The purpose of the study is to compare the efficacy of treatment with afatinib plus letrozole~     to treatment with letrozole alone in women diagnosed with a specific type of breast cancer.~   "
110965|NCT02115022|"~     Accurate staging of patients with pancreatic cancer is critical to avoid the expense,~     morbidity, and mortality related to unnecessary surgery. While several tests are available~     for assessing such patients, consensus has not been achieved on the optimal approach. As a~     matter of fact, pancreatic cancer staging is discussed controversially due to conflicting~     evidence and certainly EUS has lost grounds due to improvements in CT technology. Thus, the~     role of EUS and EUS-guided FNA varies among treatment centers.~      The present study is designed to better define the role of EUS in predicting resectability,~     as compared to high resolution cross-sectional imaging.~   "
110966|NCT02115009|"~     The overall goal of this study is to characterize the SIJ form, function, nerve entrapments,~     lumbo-pelvic configuration and their possible relationships with nonspecific chronic LBP in~     females and males. Specific aims: 1.To investigate the relationship between SIJ bridging and~     NSCLBP in females and males. 2. To investigate the prevalence and characterization of nerve~     entrapment of the lumbar sacral plexus around the SIJ in females and males. 3. To investigate~     the correlation between the lumbar sacral plexus nerve entrapments around the SIJ and NSCLBP~     in females and males. 4. To investigate the relationship between the lumbar sacral plexus~     nerve entrapments around the SIJ and lumbo-pelvic morphology in females and males. 5. To~     characterize the location and severity of articular degenerative changes in the SIJ and its~     relationship with lumbo-pelvic morphology in females and males. 6. To investigate the~     relationship between articular degenerative changes in the SIJ and LBP in females and males.~   "
110967|NCT02114996|"~     Vocal stimulation may encourage spontaneous breathing in patients dependent on mechanical~     ventilation.~      The study will include 30 patients on mechanical ventilation that will be intervened by the~     vocal stimulation and 30 patients on mechanical ventilation will serve as the control group.~   "
110968|NCT02114983|"~     Numerous studies have demonstrated excellent diagnostic accuracy of Compression~     Ultrasonography (CUS) performed by hospitals doctors, skilled and unskilled in Radiology.~      Recently, it was demonstrated that adequately ultrasonography-trained General Practitioners~     (GP) can perform reliable ultrasound to increase the speed and improve the quality of~     clinical management of various clinical conditions. To date, in the medical literature there~     are no studies that demonstrate the diagnostic accuracy of GP in performing CUS for the~     diagnosis of Deep Vein Thrombosis (DVT). Therefore, we plan to perform a prospective,~     multicenter, cohort study in which a large number of consecutive outpatients with symptoms or~     signs of DVT are subject to the CUS by the GP with the aim of evaluating the precision and~     the diagnostic accuracy compared to specialists in vascular ultrasound, which in this case~     will be the standard of reference.~   "
110969|NCT02114970|"~     The investigators will develop and test a tablet-delivered informed consent process. In a~     preliminary phase of the study, older adults will provide feedback on a prototype~     tablet-delivered consent by participating in a focus group. In a separate second phase, older~     adults will be randomly assigned to a tablet-delivered or paper-delivered consent condition~     in which their comprehension of material covered in the consent will be assessed.~   "
110970|NCT02114957|"~     This study is to investigate how human bodies absorb and metabolize two herbal drugs. The~     information is critical for drug development and could not be obtained from any other studies~     using animals. The two herbal drugs are decursin and decursinol angelate (DA) which naturally~     exist in a traditional herb Angelica gigas Nakai (AGN). Preclinical and clinical studies~     indicated that AGN and decursin/DA were quite safe to animals and human.~   "
110971|NCT02114944|"~     Patients with severe chronic diseases are often admitted to the hospital complaining of~     shortness of breath. Some of these patients decide that they do not want placement of a~     breathing tube in the windpipe to assist their breathing. In this situation, these patients~     are treated with oxygen, a variety of medications like morphine or masks that are connected~     to breathing machines, something called bilevel positive airway pressure (BiPAP) or~     noninvasive ventilation (NIV), to help with their breathing. Not much is known about how much~     noninvasive ventilation helps these patients, especially how comfortable they feel with it~     and how much their families think it helps.~      Our aim is to monitor use of ways to help breathing in patients who don't want a breathing~     tube, see how often noninvasive ventilation is used and ask surviving patients, patient's~     families and caregivers about their experience with noninvasive ventilation and how much it~     seemed to help.~      With our findings, we hope to improve the use of noninvasive ventilation in these patients~     and come up with ways to relieve their shortness of breath and provide as much comfort as~     possible.~   "
110972|NCT02114931|"~     The purpose of this open-label study is to evaluate the long-term safety and efficacy of ABP~     501 in adults with moderate to severe rheumatoid arthritis (RA).~   "
110973|NCT02114918|"~     Voluntary and involuntary attention processes are thought to play an important role in the~     development and maintenance of anxiety disorders including OCD. Individuals with OCD pay~     greater attention to threat information related to their illness and have difficulty shifting~     their attention from such triggers. Studies suggest that a change in attention bias may lead~     to a change in anxiety vulnerability. However, few studies have directly examined the causal~     role of attention bias in the maintenance of anxiety underlying OCD and whether modification~     of such biases may reduce pathological anxiety symptoms particularly in children. In this~     proposal, we aim to translate basic findings from research on cognitive biases in anxiety~     into a novel computerized intervention for child Obsessive Compulsive Disorder (OCD). The~     treatment is designed to target a basic cognitive vulnerability in OCD, namely the selective~     processing of threatening OCD-related information. 52 children with OCD will be randomly~     assigned to either a 12-session attention modification program (AMP) or an attention control~     condition (ACC). Clinical assessment of symptom severity along with a brief neurocognitive~     battery will be conducted before and after treatment. We hypothesize that children in the AMP~     group at end of treatment will show (1) decreased attention bias to OCD-related triggers~     using an independent measure of attention bias to assess change and (b) reduced OCD severity.~     This study is an initial step towards demonstrating the feasibility and efficacy of a novel~     computerized attention training program for OCD that ultimately may prove to be a highly~     transportable and accessible intervention for this childhood psychiatric disorder.~     Furthermore, the project will also examine neurocognitive performance before and after~     attention training to elucidate possible predictors and mechanisms of treatment response.~   "
110986|NCT02114749|"~     This study is aimed to develop analysis methods and measurements tools for physiological~     variables : respiration, circulation and their mutual interactions and with the functions~     involved in the daily life in healthy volunteers (drinking, eating, sleeping, coughing...).~     The devices that are used are non invasive. The development of these tools needs to be~     validated on physiological signals obtained in healthy volunteers.~   "
111863|NCT02103231|"~     The purpose of this study is to understand more about why young people who were born~     prematurely may have increased risk of high blood pressure and lower cardiovascular exercise~     capacity.~   "
110974|NCT02114905|"~     Comprehensive Behavioral Intervention for Tics (CBIT) is an evidence based intervention for~     tic disorders. A recent scientific review of research priorities completed by the Tourette~     Syndrome Association recommended widespread dissemination of CBIT as an important next step~     in services delivery research. Given early evidence that occupational therapists can deliver~     CBIT effectively, a dissemination strategy using occupational therapists may improve~     accessibility to this treatment, at lower cost and with decreased stigma. Thus the goal of~     this study is to develop and test a training and dissemination model with occupational~     therapists (OTs) using an expert, multi-disciplinary team at Weill Cornell/New York~     Presbyterian Hospital (WC/NYPH) and University of Alabama at Birmingham (UAB). The~     investigators have adapted CBIT, the gold-standard behavioral intervention program for~     children with tic disorders (Woods et al, 2008a,b), for eventual use in OT programs across~     the country.~   "
110975|NCT02114892|"~     The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult~     population suffers the disease.~      Resveratrol is a substance found in many plants, including grapes, nuts and wine, but it's~     also found in Polygonum cuspidatum. There is evidence that resveratrol consumption has~     beneficial effects on glucose and lipids metabolism, blood pressure and body weight.~      The aim of this study was to evaluate the effect of resveratrol on metabolic syndrome,~     insulin sensitivity and insulin secretion.~      The investigators hypothesis was that the administration of resveratrol modifies the~     metabolic syndrome, insulin sensitivity and insulin secretion.~   "
110976|NCT02114879|"~     The purpose of this study is to provide evidence that Enhanced Medical Rehabilitation is an~     effective treatment for older adults after disabling medical events.~   "
110977|NCT02114866|"~     Postoperative handovers to the post anaesthesia care unit (PACU) in adult anaesthesia are~     described as incomplete and unstructured, although their relevance for the patient safety is~     well known. It must be assumed that for children, this handover is at least comparable~     important.~      With a self-developed checklist information transfer during postoperative handovers will be~     documented and subsequently compared with patient information in anaesthesia records.~   "
110978|NCT02114853|"~     Sepsis is common in the ICU and is associated with high mortality that reaches up to 60%,~     increased duration of hospitalization and additional costs [1,2].Early diagnosis and~     stratification of severity are of great importance in order to timely apply proper and~     adequate treatment [3].~      Oxidative stress is implicated in inflammation and sepsis and sepsis severity seems to~     correlate with increased oxidative stress [7,8]. Monitoring of oxidative stress has been done~     so far with various markers which reflect the different pathways of oxidative stress as is~     oxidosis of lipids, proteins, nucleic acids; yet the antioxidant capacity of various enzymes~     and vitamins has been studied [9]. However these methods do not reflect oxidative stress as a~     whole, are time consuming, need special laboratory procedures and are costly.~      Oxidation-reduction potential is a new technique that enables bedside assessment of the~     oxidative status. It is based on measuring the balance of oxidants and reductants in human~     blood with a simple plasma test that reports results immediately.~      Hypothesis~      Oxidation-reduction potential, used for oxidative monitoring in ICU patients, might correlate~     with sepsis severity and may be used in addition to other clinical and/or inflammatory~     markers to assess severity and possibly prognosis.~   "
110979|NCT02114840|"~     The purpose of this study is to determine pronator quadrutus preservation have clinical~     impact following volar plate fixation~   "
110980|NCT02114827|"~     Patients in the intervention arm will view the 23-minute video depicting the Hematopoietic~     stem cell transplantation (HSCT) experience. Patients in the control arm will receive HSCT~     frequently asked questions (FAQ) sheet developed by the National Cancer Institute (NCI) at~     the National Institutes of Health (NIH).~   "
110981|NCT02114814|"~     The aim of this study is to compare the efficacy of an intervention and an attention control~     group in producing changes in diabetes self-management, A1C and health related quality of~     life in Hispanics with type 2 diabetes.~      Hypothesis: The experimental group who receive an 8 week intervention program will show~     significantly greater improvements than an attention control group at 1 and 6 months after~     the intervention in: behavioral influences of diabetes knowledge, diabetes self-efficacy, and~     family support, outcomes of self-reported management of diabetes (physical activity, diet,~     medications, and glucose monitoring), A1C levels, and psychological outcomes of~     health-related quality of life.~   "
110982|NCT02114801|"~     The aim of the present study was to determine the effectiveness of brushing with an electric~     toothbrush switched on and switched off in comparison to manual brushing for the removal of~     dental plaque in children aged four to 16 years with cerebral palsy.~   "
110983|NCT02114788|"~     The aim of the study is to study how to improve patients' management of chronic back pain,~     particularly their management of prescription medication, through increasing health literacy~     and patient empowerment through an internet based intervention. We do this by designing both~     patient education materials and physician communication strategies to increase literacy and~     volitional components of patients. We will test two conditions using a website called~     Oneself: one providing only information (literacy-only control) and a second providing~     relational communications designed to increase both literacy and volitional empowerment. To~     test the self-management enhancing effects of empowerment and health literacy, we will~     conduct a longitudinal experiment with 51 chronich back pain patients over two months. This~     span of time is the minimum necessary to achieve a systematic change in self-management and~     literacy skills, increasing also the range of possible decisions to be made and actions to be~     real-ized by the patients.~   "
110984|NCT02114775|"~     The overall goal is to determine whether perceptual or performance fatigue can be reduced in~     MTBI patients with and without growth hormone (GH) deficiency by treating them in a crossover~     fashion based upon GH status.~      A battery of functional, fatigue, cognitive, imaging and blood flow tests will be performed~     to assess the efficacy of the two drug interventions, Growth hormone and Sildenafil.~   "
110985|NCT02114762|"~     This study evaluates the usefulness and safety of using a balloon to dilate (make larger) the~     Eustachian tube in adults who have middle-ear disease due to Eustachian tube dysfunction.~   "
113561|NCT02081001|"~     The purpose of the study is to assess the safety, speed of absorption, and onset of action of~     G-Pump™ (glucagon infusion) at three subcutaneous doses as compared to Novo GlucaGen®, all~     delivered via an OmniPod® infusion pump to patients with type 1 diabetes.~   "
110987|NCT02114736|"~     Stiff knee gait is defined as the lack of knee flexion in the swing phase of gait. Stiff knee~     gait is a frequent condition among stroke patients leading to reduce gait speed and increase~     energy cost. In association with neuro-rehabilitation, botulinum toxin A injections in the~     rectus femoris is recommended. However, the botulinum toxin A effect is transient~     necessitating repeated injections.~      The aim of this study is to compare the benefit of the rectus femoris tenotomy in comparison~     with botulinum toxin A injections according to the 3 domains of the International~     Classification of Functioning Disability and Health of the World Health Organisation~   "
110988|NCT02114723|"~     Determine the effectiveness of a proceeding under kinesio tape on pain and systemic symptoms~     most frequently described in primary dysmenorrhea.~   "
110989|NCT02114710|"~     The purpose of this study is to find out whether stress doses of hydrocortisone attenuate~     coagulation dysfunction in patients with septic shock. And discuss the probable mechanism by~     which little doses of hydrocortisone influence coagulation system in sepsis.~   "
110990|NCT02114697|"~     The goal of this study is to assess a slimy substance that settles/deposits along blood~     vessel wall. This slimy substance is called plaque. Plaque could be made up of fat, calcium~     or both. Plaque deposition narrows the vessels. This leads to decreased blood flow to various~     parts of body. Blood vessels include vessels that supply to heart (coronary), vessels to~     brain (carotid), vessels to kidneys (renal) and vessels to legs (femoral). Decreased blood~     flow causes symptoms such as brain stroke, heart attack, leg pain. Similarly individuals at~     risk of cardiovascular disease can have certain markers elevated in their blood that can be~     measured by simple blood tests.~      High or increased plaque deposition is seen in neck vessels of cancer patients who received~     radiation to chest or head and neck as part of their cancer treatment. Cancer survivors are~     at increased risk of plaque development and are therefore called high-risk population.~     Exercise +/- fat lowering medicine can potentially decrease plaque deposition and statins are~     one of the several fat lowering medications.~   "
110991|NCT02114684|"~     This is an open label randomized controlled clinical trial comparing two regimens for~     treatment of smear-positive pulmonary TB, among patients previously treated for TB. The~     primary objective is to determine if a moxifloxacin-containing regimen, substituting~     moxifloxacin for ethambutol, of 24 weeks duration is superior to a control regimen of 24~     weeks duration in improving treatment outcomes in patients with recurrent TB and shortens the~     duration of TB treatment.~   "
110992|NCT02114671|"~     To investigate the potential of Faldaprevir to induce skin phototoxicity, immediate or~     delayed type, to UV light and visible light in healthy male and female subjects. To~     investigate the degree, wavelength dependency, severity, pigmentation and morphology of the~     phototoxic effects. The persistence of the phototoxic susceptibility will be explored~     following cessation of study medication. Within a sunscreen sub-study, the efficacy of~     commercially available high factor sunscreen will also be assessed in terms of its potential~     to prevent any phototoxic skin responses seen. The safety and tolerability of Faldaprevir~     will also be assessed.~   "
110993|NCT02114658|"~     The objectives of this study are to evaluate safety, efficacy and pharmacokinetics of~     sorafenib for the treatment of Japanese patients with anaplastic thyroid carcinoma (ATC) or~     locally advanced or metastatic medullary thyroid carcinoma (MTC).~   "
110994|NCT02114645|"~     This prospective clinical trial evaluates the effect of a two dose GnRH agonist administered~     in the luteal phase on the outcome of ART cycles stimulated with the long GnRH agonist and~     GnRH antagonist protocol.~   "
110995|NCT02114632|"~     The purpose of the study is assessing the efficacy of Omega - 3 and Omega - 6 treatment in~     boys with Attention-Deficit/Hyperactivity Disorder (ADHD) compared with control group healthy~     boys.~   "
110996|NCT02114619|"~     Radioactive iodine (RAI) administration is an effective and completely established treatment~     modality in hyperthyroidism including Graves' disease. Despite the long experience with~     radioiodine for hyperthyroidism, controversy remains regarding the optimal dose of iodine~     that is required to achieve long-term euthyroidism. The fixed activity administration method~     does not optimize the therapy, giving often too high or too low radiation to the gland, but~     the optimal dose per gram of thyroid mass in calculated activity administration method is~     also under much debates. This prospective study has been designed in order to compare the~     effect of different calculated doses of radioiodine on Graves' disease treatment outcome.~   "
110997|NCT02114606|"~     The current endoscopic methods for diagnosing and monitoring treatment response in~     Eosinophilic Esophagitis (EoE) are costly, inconvenient, and risky. Novel diagnostic methods~     are needed, and the minimally-invasive Cytosponge holds great promise. It has been shown to~     be safe and accurate in Barrett's esophagus, it has the advantage (over the string test) of~     obtaining a true tissue sample, and our preliminary data supports its further study in EoE.~     The proposed prospective cohort study, conducted by experts in esophageal diseases and EoE,~     will assess the accuracy of Cytosponge compared to endoscopy and biopsy in EoE, and determine~     the safety and acceptability of this technique. Use of the Cytosponge would fundamentally~     change the paradigm for clinical management of EoE by allowing collection of non-endoscopic~     esophageal biopsies, thus minimizing the need for invasive testing. It would also facilitate~     future genetic, mechanistic, and pathogenesis research in EoE.~   "
110998|NCT02114593|"~     The aim of this project is to evaluate the effectiveness of a culturally adapted parenting~     support program for Somali parents living in Sweden on children's and parent´s mental health.~     In recent years the Somali population in Sweden has increased and is currently one of the~     largest groups among ethnic minorities. Most of the Somali people have arrived as refugees~     and have experienced war, trauma and conflict. Research shows that migration to a new social~     context/society is challenging for a family and may together with previous experiences of~     war, separation, create stress and mental illness. This leads to consequences such as family~     violence, child abuse, relational problems, drug problems and school problems for children.~     There is a vast knowledge on the association between parents' mental health, positive~     parent-child relationship and children's health and well-being. Previous studies have shown~     that parenting programs aimed to support parent-child relationship and/or improve parental~     skills have positive effects on parental mental health and on children's behavior. Most~     municipalities in Sweden offer their residents a structured parenting program, but these~     programs do not reach those of ethnic minorities. Studies show that parenting programs mainly~     target parents who can speak Swedish fluently and that the parenting programs are not yet~     culturally adapted.~   "
110999|NCT02114580|"~     The proposed study aims to explore brain mechanisms mediating the cognitive benefits of~     aerobic exercise in patients with mild cognitive impairment- a prodromal stage of Alzheimer~     disease. We will perform FMRI experiments, as well as laboratory and behavioral tests that~     will advance our knowledge about the nature of these mechanisms. Participants will~     participate in individual- tailored aerobic training program. Pre and post evaluation will~     identify brain changes following the training using advanced techniques of brain imaging.~     Cognitive performance will be assessed prior and at the end of the program, as well as~     endocrine markers reflecting improvement in learning abilities. Moreover, demonstrating~     cortical plasticity in subjects with aMCI has tremendous practical significance for these~     subjects .~   "
111000|NCT02114567|"~     Acute exacerbation of chronic obstructive pulmonary disease patients with intrinsic positive~     end-expiratory pressure (PEEPi), Neurally adjusted ventilatory assist (NAVA) reduce work of~     breathing and trigger delay at any external positive end-expiratory pressure (PEEPe) level~     compared with pressure-support ventilation (PSV)~   "
111001|NCT02114554|"~     Mitochondrial diseases are multisystem disorders that present with a wide range of clinical~     manifestations. Mitochondrial DNA nt3243A>G mutation is one of the most common mutations seen~     in mitochondrial diseases. Syndromes associated with this mutation include mitochondrial~     encephalopathy, lactic acidosis, and stroke-like episodes (MELAS), maternally inherited~     diabetes and deafness (MIDD), myoclonic epilepsy with ragged red fibers (MERRF), and chronic~     progressive external ophthalmoplegia (CPEO). Clinical analyses of mitochondrial DNA nt3243A>G~     mutation from Taiwan remain scarce. The present study aims to investigate the clinical~     features and prognostic factors of patients with mt3243A>G mutation in Taiwan.~   "
111002|NCT02114541|"~     The relationship of the natural history of atherosclerosis between different vascular beds~     has not been well characterized. Determination and comparison of the relative rates of~     progression and extents of atherosclerosis in the coronary and carotid arterial trees may~     have major impacts on clinical research and clinical practice. Correlation between findings~     in the carotid and coronary circulations is an important scientific and clinical topic to~     address. Results from a well design study incorporating imaging technologies that currently~     represent the gold standards for the assessment of coronary and carotid artery plaque burden,~     will have potentially impact on clinical research and clinical practice.~   "
111003|NCT02114528|"~     The purpose of this study is to determine whether catheter based ablation is better than~     conventional anti-arrhythmic drug (AAD) therapy for reducing recurrent shocks in patients~     with an implantable cardioverter defibrillator (ICD). The second purpose of the study is to~     determine the safety of catheter-based ablation and the effect on quality of life of~     patients.~      The study hypothesis is that catheter ablation is superior to AAD therapy in preventing~     recurrent ventricular arrhythmia in such subjects. This is a pilot trial which will provide~     data regarding recruitment potential and the feasibility of conducting a larger trial.~   "
111004|NCT02114515|"~     Staying out of the hospital is valued by patients and their caregivers. Their interests~     converge with those of hospitals now that high 30-day readmission rates for some conditions~     place hospitals at risk for financial penalties from the Centers for Medicare and Medicaid~     Services. This study focuses on developing and testing a program that combines a community~     health worker (lay patient advocate, acting as a Patient Navigator) and a peer-led~     telephone support line to improve patient experience during hospital to home transition.~   "
111005|NCT02114502|"~     The goal of this clinical research study is to learn if carfilzomib and vorinostat combined~     with gemcitabine, busulfan, and melphalan with a stem cell transplant will help to control~     multiple myeloma (MM). Researchers also want to learn about the safety and effectiveness of~     this combination.~   "
111006|NCT02114489|"~     Aseptic osteonecrosis of the hip (AOH) concern 1 Swiss young adult to 1000 (30-40 years old).~     They are responsible to a severe joint destruction and in the majority of cases a joint~     replacement. To the hip, we can distinguish 4 stages of osteonecrosis according to Ficat: 1,~     2, 3, 4. Stage 3 and 4 AOH management are unanimous surgical. But management of stage 1 and 2~     are unclear. Bisphophonates are mainly used for bone and osteoporosis diseases. They decrease~     the bone turn over, and the risk of fracture. They also decrease the bone marrow oedema and~     the pain associated to this oedema. Ibandronate is a bisphosphonate with a rapid effect, a~     short half-life, easy to manage, and with few side effects. We designed a double-blind~     prospective randomized trial aiming to evaluate the efficacy of an infusion of ibandronate~     versus placebo on pain and AOH progression in patients with stage 1 and 2 AOH. Our hypothesis~     is that there will be a pain reduction >=20 mm on the VAS scale (SD 10mm) in the ibandronate~     group versus placebo, and a non radiological progression in the treated group.~   "
111007|NCT02114476|"~     The purpose of this study is to determine the effect of implantable contraception on the~     incidence of diabetes mellitus in women with history of gestational diabetes mellitus~     comparing with those using nonhormonal contraceptives.~   "
111008|NCT02114463|"~     Pain after amputation is a significant problem among amputees. Phantom limb pain may appear~     in up to 85% of patients and is usually resistant to a wide variety of treatments.It is~     believed that regional anesthesia, by preventing the establishment of central sensitization,~     may play a role in reducing the incidence of acute and chronic pain. Therefore the~     investigators will compare two methods of postoperative analgesic after after amputation by~     their efficiency and complication.~   "
111009|NCT02114450|"~     This research study will investigate the use of smart lower limb robotic exoskeleton~     (developed by the CSIC, Spain) in rehabilitation after stroke. It will compare~     robotic-assisted rehabilitation with supervised motor practice. Additionally, it will also~     examine the use of noninvasive scalp electroencephalography (EEG) to learn specific brain~     wave patterns associated with learning to walk on the powered lower limb exoskeleton. The~     findings will be used to understand human-robot interaction and to design smart orthotic~     devices that can be controlled by thought activity and assist those that have lost all or~     part of their walking abilities.~   "
111010|NCT02114437|"~     Laparoscopic Cholecystectomy applied to Artificial pneumoperitoneum and the extent of~     Surgical stimulation cause the wave of hemodynamics increase vigorously, which make it~     difficult to judge the depth of anesthesia according to traditional hemodynamics index such~     as heart rate and blood pressure.In case of this, the investigators design this research to~     study the Closed-Loop Target Controlled Infusion to anaesthesia of individualization guided~     by a Narcotrend index monitor in Laparoscopic Cholecystectomy.~   "
111011|NCT02114424|"~     POSAS can be treated with CPAP however there is now evidence from a few studies that Night~     Balance is effective in POSAS. Night Balance seems to be better accepted than CPAP so we~     would like to examine if we could find similar results in routine clinical work and~     especially we would like to confirm the subjective effects with objective measures i.e. a~     reduction in AHI in the supine position during sleep.~   "
111012|NCT02114411|"~     Background: Atrophic gastritis (AG) is the single most important precursor condition for~     gastric cancer (GC) known so far. H. pylori infection is the most important causative agent~     of gastritis, and subsequent AG. The GastroPanel test (Biohit HealthCare, Helsinki, Finland),~     a blood test evaluating the four biomarkers specific for the gastric mucosa pepsinogen I~     (P-PGI), pepsinogen II (P-PGII), gastrin-17 (P-G-17) and H. pylori antibody (P-HpAb), is the~     first non-invasive diagnostic tool providing possibilities for detecting the patients at risk~     for GC and peptic ulcer as well as malabsorption of vitamin B12, iron, magnesium, calcium and~     some drugs. A well designed clinical study is warranted to fully assess the performance of~     GastroPanel examination in detecting the gastric lesions which can lead to GC. The~     investigators aim to perform a clinical study in an adult population in United Kingdom in~     order to determine the diagnostic accuracy of the GastroPanel test in evaluating AG and other~     specific gastric conditions associated with an increased risk for GC. Methods: Two hundred~     and fifty patients (45 years and older, both genders) will be enrolled among the patients~     with dyspepsia referred for gastroscopy at Homerton University Hospital (London, United~     Kingdom). During the same visit, all patients are subjected to gastroscopy examination, with~     directed biopsies from the antrum and corpus, following the protocol of the operative link on~     gastritis assessment (OLGA) classification for chronic gastritis and Sydney Classification.~     Biopsies are examined at the Pathology laboratory of Homerton University Hospital and~     interpreted using the OLGA staging system as well as the Sydney system for classification of~     gastritis. Specific aims: The principal goal of this clinical trial is to establish the~     performance of the GastroPanel examination in detecting AG and other specific gastric~     conditions associated with an increased risk for GC. In particular, the investigators will~     evaluate AG in the antrum, AG in the corpus, AG in both antrum and corpus (=atrophic~     pangastritis), biopsy-confirmed dysplasia (intestinal metaplasia) of the gastric mucosa. For~     all these conditions, the investigators will calculate the diagnostic accuracy of the~     GastroPanel test.~   "
111013|NCT02114398|"~     The study aim is to compare usual asthma crisis treatment of hospitalized children with usual~     treatment associated to sophrology.~   "
111014|NCT02114385|"~     Primary objective~      To demonstrate that administration of the 9vHPV vaccine induces non-inferior Geometric Mean~     Titres (GMTs) for serum anti-HPV 6, 11, 16, and 18, compared to GARDASIL in 16- to~     26-year-old men~   "
111015|NCT02114372|"~     The purpose of this study is (i) Main Study: To describe the baseline characteristics~     (including demographics, cognitive status, and other measures) and the cognitive and~     functional changes of persons at risk for developing Alzheimer's disease (AD).~      (ii) SubStudy: To investigate the longitudinal change of the components of the Preclinical~     Alzheimer Cognitive Composite (PACC) and the components of the Repeatable Battery for the~     Assessment of Neuropsychological Status (RBANS) in asymptomatic at risk for AD (ARAD)~     individuals compared with individuals not classified as ARAD.~      (iii) NeuroVision Ancillary Study: To explore correlation between retinal amyloid beta~     plaques identified by fluorescence with amyloid positron emission tomography (PET)~     Standardized Uptake Value Ratio (SUVR) and cerebrospinal fluid (CSF) amyloid beta 42 testing~     in participants at risk for Alzheimer's dementia.~   "
111016|NCT02114359|"~     The investigators compare the overall survival between combination chemotherapy and~     monochemotherapy as a first-line chemotherapy in elderly patients with metastatic or~     recurrent gastric cancer. The investigators also compare the progression free survival,~     response rate, safety, and, quality of life between two groups, and evaluate that the~     comprehensive geriatric assessment tested at baseline can predict the toxicity and compliance~     of treatment, survival of the patients.~   "
111017|NCT02114346|"~     The aim of this study is to determine the efficacy of atorvastatin in the prevention of~     contrast-induced nephropathy in patients undergoing computed tomography coronary angiography.~     Investigators assume that atorvastatin is effective in this regard. Investigators include~     patients referring for elective computed tomography coronary angiography and allocate them to~     atorvastatin or placebo from 24 hours before to 48 hours after administration of contrast~     material. Investigators then measure serum creatinine and see if it is raised by ≥ 0.5 mg/dL~     or ≥ 25% of the baseline value.~   "
111018|NCT02114333|"~     This study will compare the two vaccines that have been developed to prevent and/or lessen~     the effects of shingles. One vaccine is live (Zostavax, licensed by FDA) and the other,~     herpes zoster subunit (HZ/su), contains a piece of the shingles virus (not live) and an~     ingredient that may enhance the body's immune response to the vaccine, and is currently~     investigational. The vaccines are being compared to assess their ability to stimulated~     protection against shingles. The study will provide an opportunity to determine the safety~     profile of each vaccine in a single trial. The study will also look at the effect of age on~     the immune response to the two vaccines and on the persistence of these responses.~   "
111019|NCT02114320|"~     Although endoscopic retrograde cholangiopancreatography (ERCP) is almost always successful in~     patients with malignant biliary obstruction, selective biliary cannulation fails in some~     cases and conventional ERCP may not be possible in patients with tumor invasion of the~     duodenum or major papilla, surgically altered anatomy (e.g., Roux-en-Y anastomosis), or~     complex hilar biliary strictures. In such cases, percutaneous transhepatic biliary drainage~     (PTBD) is an useful alternative. However, PTBD had various complications and the presence of~     an external drainage catheter would also have a cosmetic problem related to the external~     drainage and an adverse impact on quality of life (QOL) of terminally ill patients.~      Since endoscopic ultrasound-guided bile duct puncture was described in 1996, sporadic case~     reports of EUS-guided biliary drainage (EUS-BD) suggested that it was a feasible and~     effective alternative in patients with failed conventional ERCP stenting. The potential~     benefits of EUS-BD include one-stage procedure in ERCP unit, and internal drainage for~     avoiding long-term external drainage in cases where external PTBD drainage catheters cannot~     be internalized, thus significantly improving the QOL of terminally ill patients, and~     possibly lower morbidity than PTBD or surgery.~      Up to date, only a few case series of EUS-BD with small numbers of patients have been~     published, and known the feasibility and safety in terms of the incidence of~     procedure-related clinical outcomes.~   "
111020|NCT02114307|"~     To investigate the efficacy of an electrical stimulation (using the REVITIVE IX device) in~     treating patients with venous insufficiency.~   "
111028|NCT02114203|"~     This study is being conducted to assess the safety, tolerability, pharmacokinetics and~     pharmacodynamics of an investigational drug, PF-04447943, in subjects with stable sickle cell~     disease with and without co-administration with hydroxyurea. This study will also aid in~     selecting the doses for future studies and evaluation of substances in the blood which may~     help access the effectiveness of the drug.~   "
111021|NCT02114294|"~     This is a Randomized Controlled Trial (RCT) regarding conservative treatment of~     Patellofemoral Pain Syndrome (PFPS). Patellofemoral Pain Syndrome (PFPS) is a very common~     cause of knee pain in young active adults with a high rate of recurrent and/or chronic~     occurrence. PFPS is notoriously difficult to treat and has been referred to as one of the~     most vexatious clinical challenges in rehabilitative medicine. Its etiology is unclear but~     is commonly thought to be related to pathomechanics in the patellofemoral joint (PFJ). There~     are many factors that can influence PFJ mechanics. Among these, quadriceps strength and~     timing has been shown to be important. As such, treatment of PFPS has traditionally been~     based on correction of pathomechanics through influencing quadriceps strength and timing.~     However, a growing body of evidence is revealing the importance of strength and control of~     hip abduction and external rotation in PFPS. Hip strength in ab/adduction and rotation is~     thought to influence femoral positioning in the patellofemoral joint, thereby affecting PFJ~     mechanics. Several cohort and smaller RCT studies within the last 7 years have shown that~     additional exercises for hip strength and control give an improved effect in pain and~     function compared with quadriceps based training alone. A smaller RCT from 2012 compared~     isolated hip strengthening exercises to a control group and found surprisingly good results~     on pain in function in the hip strengthening group. The investigators plan a RCT in which~     isolated hip strengthening will be compared to traditional quadriceps training and a control~     group which will receive no structured training. Primary outcomes will be pain and function.~     This high-quality study will include 40-50 patients in each group, making it one of the~     largest of its kind on conservative treatment for PFPS. In contrast to the vast majority of~     studies of this type, this study will also include men, which will potentially help to fill a~     significant gap in the literature on this subject. The investigators study will therefore be~     an important contribution to elucidating the etiology of PFPS and improving treatment options~     for both men and women in the future. As well, the role of psychometric parameters will be~     examined and a standardized clinical test for hip abduction endurance will be developed.~   "
111022|NCT02114281|"~     A large panel of oral and dental diseases exist in patients suffering from chronic kidney~     disease (CKD) in end-stage renal disease: it concerns teeth, peridontium, alveolar bone and~     saliva and it has been already described in the literature. The consequences of oral diseases~     in systemic health are substantial, including increase of inflammatory parameters, alteration~     of nutrition and increase of cardiovascular risk factors. It has been shown before that~     several oral diseases can be considered as cardiovascular risk factor in the general~     population and in diabetic patients through the chronic inflammatory pathway. In CKD~     patients, the influence of oral diseases on the progression of the chronic kidney disease is~     not yet established, as most of the studies are focused on stage 5 CKD or dialysis patients.~     That's why the interactions between dental health and CKD will be evaluated in this~     population of patients, at different stages of the disease (stages 2 to 5).~      The main objective will be to describe the oral diseases at each stage of CKD. Secondary~     objectives will be: (1) To evaluate the link between the oral health and the chronic kidney~     disease stage, the nutritional and inflammatory status; (2) Among patients needing dental~     treatments, to evaluate after 6 months and 12 months whether dental cares have an influence~     on nutrition parameters, inflammatory status and CKD; (3) to evaluate the completion of~     dental treatments after the dental consultation including advises on dental health.~   "
111023|NCT02114268|"~     The purpose of this study was to evaluate the safety, tolerability and pharmacokinetics of an~     extended half-life anti-respiratory syncytial virus (RSV) monoclonal antibody compared to~     placebo when administered to healthy adult participants.~   "
111024|NCT02114255|"~     In the present study, the investigators want to investigate whether prior BCG-vaccination~     improves the efficacy of influenza (the flu) vaccination in young and/or old healthy~     volunteers and consequently could protect against influenza virus infection.~   "
111025|NCT02114242|"~     Parkinson disease (PD), multiple system atrophy (MSA) and progressive supranuclear palsy~     (PSP) are neurodegenerative disorders. PD and MSA are alpha-synucleinopathies, which are~     characterized by the abnormal accumulation of alpha-synuclein, while tau protein accumulates~     in PSP. The development of biological markers for the diagnosis and prognosis in PD, MSA and~     PSP remains an unmet need. Such biological markers are crucial for future~     disease-modification and neuroprotection trials. Alpha-synuclein has a high potential for~     biomarker development since it constitutes the pathological hallmark feature in PD and MSA.~     The oligomeric alpha-synuclein seems to be particularly involved in abnormal protein~     aggregation in alpha-synucleinopathies.~      The main objective is to compare oligomeric alpha-synuclein CSF levels between PD, MSA and~     PSP patients. PD and MSA patients will receive Cerebrospinal Fluid (CSF) and blood sampling~     at two study visits (baseline and after 12 months). Major secondary objectives are (i) to~     assess potential associations between the biomarker and clinical measures of disease severity~     and progression in MSA and PSP, and (ii) to assess the variation of the biomarker and its~     correlation to disease severity and progression in PD, MSA and PSP.~   "
111026|NCT02114229|"~     This study incorporates alisertib, the small-molecule inhibitor of Aurora A activity, in the~     treatment of patients younger than 22 years of age. Patients with recurrent or refractory~     AT/RT or MRT will receive alisertib as a single agent. Patients with newly diagnosed AT/RT~     will receive alisertib as part of age- and risk-adapted chemotherapy. Radiation therapy will~     be given to children ≥12 months of age. Patients with AT/RT and concurrent extra-CNS MRT are~     eligible.~      Alisertib will be administered as a single agent on days 1-7 of each 21-day cycle in all~     recurrent patients enrolled on Stratum A. For the patients on the newly diagnosed strata (B,~     C or D), alisertib will be administered in sequence with chemotherapy and radiotherapy.~      This study has 3 primary strata: (A) children with recurrent/progressive AT/RT or extra-CNS~     MRT, (B) children < 36 months-old with newly diagnosed AT/RT, (C) children > 36 months old~     with newly diagnosed AT/RT. Children with concurrent MRT will be treated according to age and~     risk stratification schemes outlined for strata B and C and will have additional treatment~     for local control. Children with synchronous AT/RT will be treated with age and CNS~     risk-appropriate therapy, and also receive surgery and/or radiation therapy for local control~     of the non-CNS tumor.~      PRIMARY OBJECTIVES~        -  To estimate the sustained objective response rate and disease stabilization in pediatric~          patients with recurrent or progressive AT/RT (atypical teratoid rhabdoid tumor in the~          CNS) (Stratum A1) treated with alisertib and to determine if the response is sufficient~          to merit continued investigation of alisertib in this population.~        -  To estimate the sustained objective response rate and disease stabilization in pediatric~          patients with recurrent or progressive extra-CNS MRT (malignant rhabdoid tumor outside~          the CNS) (Stratum A2) treated with alisertib and to determine if the response is~          sufficient to merit continued investigation of alisertib in this population.~        -  To estimate the 3-year PFS rate of patients with newly diagnosed AT/RT who are younger~          than 36 months of age at diagnosis with no metastatic disease (Stratum B1) treated with~          alisertib in sequence with induction and consolidation chemotherapy and radiation~          therapy (depending on age) and to determine if the rates are sufficient to merit~          continued investigation of alisertib in this population.~        -  To estimate the 1-year PFS rate of patients with newly diagnosed AT/RT who are younger~          than 36 months of age at diagnosis, with metastatic disease (Stratum B2) treated with~          alisertib in sequence with induction and consolidation chemotherapy and to determine if~          the rates are sufficient to merit continued investigation of alisertib in this~          population.~        -  To estimate the 3-year PFS rate of patients with newly diagnosed AT/RT who are 3 years~          of age or greater at diagnosis with no metastatic disease and gross total resection or~          near total resection (Stratum C1) treated with alisertib in sequence with radiation~          therapy and consolidation chemotherapy and to determine if the rates are sufficient to~          merit continued investigation of alisertib in this population.~        -  To estimate the 1-year PFS rate of patients with newly diagnosed AT/RT who are 3 years~          of age or greater at diagnosis with metastatic or residual disease (Stratum C2) treated~          with alisertib in sequence with radiation therapy and consolidation chemotherapy and to~          determine if the rates are sufficient to merit continued investigation of alisertib in~          this population.~        -  To characterize the pharmacokinetics and pharmacodynamics of alisertib in pediatric~          patients and to relate drug disposition to toxicity.~      SECONDARY OBJECTIVES~        -  To estimate the duration of objective response and PFS in patients with~          recurrent/progressive AT/RT and MRT (Strata A1 and A2).~        -  To estimate PFS and OS distributions in patients with newly diagnosed AT/RT (Strata B1,~          B2, B3, C1 and C2).~        -  To describe toxicities experienced by patients treated on this trial, specifically any~          toxicities of alisertib when administered as a single agent or in combination with other~          therapy over multiple courses and toxicities related to proton or photon radiation~          therapy.~        -  To describe the patterns of local and distant failure in newly diagnosed patients~          (Strata B1, B2, B3, C1 and C2). Local control relative to primary-site radiation~          therapy, with criteria for infield, marginal, or distant failure will also be reported~          descriptively.~   "
111027|NCT02114216|"~     Transient receptor potential vanilloid-1 (TRPV1) receptor and proteinase-activated receptor 2~     (PAR2) have been implicated in the mechanism of acid induced inflammation in gastroesophageal~     reflux disease (GERD). We aimed to evaluate TRPV1 and PAR2 mRNA expression levels in the GERD~     patients and their relationship with endoscopic findings and reflux symptoms.~   "
111096|NCT02113319|"~     In patients with Core Binding Factors Acute Myelogenous Leukemia, the level of Minimal~     Residual Disease after chemotherapy is predictive of relapse. The relapse risk is also~     increased in case of mutations of receptors tyrosine kinase. For patients with a high Minimal~     Residual Disease level at the end of consolidation or in molecular relapse, maintenance by~     the inhibitor dasatinib is proposed.~   "
111029|NCT02114190|"~     With currently 35% of U.S. adolescents being overweight and one in six having metabolic~     syndrome, adolescent obesity is one of the major global health challenges of the 21st~     century. Few enduring treatment strategies have been identified in adolescent populations and~     the majority of standard weight loss programs fail to adequately address the impact of~     psychological factors on eating behavior and the beneficial contribution of parental~     involvement in adolescent behavior change. A critical need exists to expand treatment~     development efforts beyond traditional education and cognitive-behavioral programs and to~     explore alternative treatment models for adolescent obesity. Meditation-based mindful eating~     programs may represent a unique and novel scientific approach to the current adolescent~     obesity epidemic as they address key psychological variables affecting weight. Furthermore,~     the recent expansion of mindfulness programs to include family relationships shows the~     immense potential for broadening the customarily individual focus of this intervention to~     include broader factors thought to influence adolescent health outcomes. Thus, we propose to~     develop a mindful eating approach to eating behavior and weight loss specifically tailored~     for adolescents and their families. The first phase of our three phase development process~     will be devoted to adapting an adolescent protocol (Mindful Eating-A) based on an established~     mindful eating program currently being used with adult populations. We will then develop a~     'family enhanced Mindful Eating-A' (Mindful Eating-A+F) protocol that integrates a family~     systems perspective. The goal of Mindful Eating-A+F is to expand the focus of Mindful~     Eating-A to include family factors that influence adolescent eating behaviors. The second~     design phase will consist of an initial test of both intervention components to provide~     feedback on usefulness and acceptability (N = 10 families). The final phase will examine the~     overall efficacy of the optimized Mindful Eating-A+F, relative to the Mindful Eating-A~     intervention with 30 overweight adolescents (BMI > 85th percentile) ages 14-17 and at least~     one parent. Within this examination, post-treatment and 3-month follow-up comparisons across~     the two treatment approaches will be made and effect sizes within and between treatments will~     be assessed.~   "
111030|NCT02114177|"~     The purpose of the study is to evaluate the efficacy and safety of a treatment regimen of 12~     weeks or 8 weeks of simeprevir in combination with sofosbuvir in chronic hepatitis C virus~     (HCV) genotype 1 infected men and women without cirrhosis who are HCV treatment-naïve or~     treatment-experienced.~   "
111031|NCT02114164|"~     The AirSeal® System will allow for lower CO2 absorption rates than the Xcel® System.~     Furthermore, lower variance in pneumoperitoneal pressure will allow for less over-pressure~     events and peritoneal stretch, which may reduce postoperative pain.~   "
111032|NCT02114151|"~     The purpose of the study is to investigate the efficacy and safety of 12 weeks of simeprevir~     (150 mg qd) in combination with sofosbuvir (400 mg qd) in chronic hepatitis C virus (HCV)~     genotype 1 infected men and women with cirrhosis who are HCV treatment-naïve or~     treatment-experienced.~   "
111033|NCT02114138|"~     The risk for postoperative acute kidney injury (pAKI), as for any other postoperative~     complications (PC), comes from a number of interactions between a patient's health before~     surgery, strength to tolerate surgery and influences on the operating room environment. At~     this time doctors do not have good tools to predict which patients may be at risk of having~     this complication. The purpose of this research study is to develop a urine test that can be~     used to predict the risk for having problems with kidney function after major surgery.~   "
111034|NCT02114125|"~     Investigators assume that there are some positive effects of cognitive training and physical~     activities on cognitive function, depression and quality of life in a sample of older~     residents in long-term care facilities.~      The purpose of this study is to explore the effects of various interventions (physical~     activity, cognitive training, integration of physical activity and cognitive training) on~     different outcome indictors in institutionalized older residents.~   "
111035|NCT02114112|"~     Objective: To compare the effectiveness of nasal continuous positive airway pressure (NCPAP)~     cycling to continuous NCPAP in successful weaning of preterm infants of 25-28 weeks gestation~     to nasal prongs.~      Methods: A total of 40 infants with a gestational age (GA) of 25-28 weeks ventilated for~     respiratory distress syndrome (RDS) and extubated to NCPAP are eligible for the study. They~     will be randomized to NCPAP cycling {Group A; cycling between NCPAP of 4 cm and 1litre per~     minute of nasal prongs} or to continuous CPAP at 4 cm of water (Group B). Primary outcome is~     the number of babies who came off NCPAP at the end of 72 hours of the intervention and~     remained off NCPAP for the next 72 hours. The duration of NCPAP, Bronchopulmonary dysplasia~     (BPD) at 36 weeks post menstrual age and Retinopathy of Prematurity (ROP) stage ≥3 will be~     the secondary outcomes.~   "
111036|NCT02114099|"~     Background Kawasaki disease (KD) is characterized by fever, bilateral nonexudative~     conjunctivitis, erythema of the lips and oral mucosa, changes in the extremities, rash, and~     cervical lymphadenopathy. Incidence of late coronary artery aneurysms or ectasia, which may~     lead to myocardial infarction (MI), sudden death, or ischemic heart disease, decreased after~     the introduction of intravenous immunoglobulin therapy. However, significant persistent~     coronary arterial lesions or aneurysms may still occur in about 1-3 % of the patients.~      Atorvastatin (Lipitor®), a kind of statin, is a selective competitive inhibitor of~     3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This drug had been safely and~     widely used for treatment of adult hyperlipidemia, prevention of coronary heart disease and~     familial hypercholesterolemia in childhood. In addition to the cholesterol-lowering effects,~     statins exerts diverse cellular, cholesterol-independent effects, including improvement in~     endothelial function, inhibition of neurohormonal activation, and reduction in levels of~     proinflammatory cytokines. Based on the above concepts, some patients with infrarenal~     abdominal aortic aneurysms received statin therapies and then the growth rate of aneurysms~     slowed down.~      Therefore, the investigators may hypothesize that Atorvastatin is helpful in the regression~     of persistent coronary lesions in KD patients due to its effect of anti-inflammation. In~     NTUH, there are about 20 KD patients with coronary lesions persistent for many years. And the~     investigators plan to conduct the clinical trial with atorvastatin to evaluate the effects of~     Atorvastatin on the persistent coronary arterial lesions/aneurysms in children with Kawasaki~     disease including safety and efficacy.~      Methods~      There are around 20 KD patients eligible for this study. After they sign the IRB-approved~     ICF, they will be enrolled for this study. Briefly, this study is divided into three stages:~     screening & enrollment stage (I), treatment & follow-up stage (II) for 1 year and final data~     analysis stage (III). Measurements include basic vital sign, electrocardiography, liver~     function, muscle enzyme, inflammatory markers and echocardiography.~      Predicted results~      1.Oral atorvastatin therapy can effectively prevent the progression of coronary lesions in KD~     patients.~   "
111037|NCT02114086|"~     In this study the investigators observe the investigation, whether the new method for~     Boost-Irradiation with the Intrabeam Device of Zeiss Germany influences local recurrence,~     acute and late effects of Radiotherapy, overall survival, quality of life and cosmesis.~   "
111038|NCT02114073|"~     Glaucoma is one of the leading causes of blindness worldwide and trabeculectomy is the most~     commonly performed operation to slow-down the disease progression. In this study, we compare~     the effect of topical cyclosporine A and betamethasone eye drops on the postoperative course~     and surgical success of trabeculectomy.~   "
111058|NCT02113813|"~     The purpose of this study is to assess the safety and tolerability of ASP8273 and to~     determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). This study~     will also determine the pharmacokinetics (PK) of ASP8273, evaluate the potential inhibition~     of CYP3A4 by ASP8273 and the antitumor activity of ASP8273 as well as determine the effect of~     food on the bioavailability of ASP8273.~   "
111103|NCT02113228|"~     This study proposes to verify the total energy expenditure in patients with short bowel~     syndrome using the doubly labeled water method, as well as determining the rate of oxidation~     of nutrients, aiming to assist the management of nutritional therapy for these patients.~   "
111039|NCT02114060|"~     This is a randomized, double-blind, factorial study to compare the reduction in viral~     shedding among 6 different combinations of GEN-003, a therapeutic HSV-2 vaccine and Matrix-M2~     adjuvant.~      Secondary objectives of the study include:~        -  Evaluation of the safety and tolerability of GEN-003 in combination with Matrix-M2~          compared to placebo.~        -  Comparison of the impact on clinical Herpes Simplex Virus type-2 (HSV-2) disease among~          the 6 different combinations of GEN-003 antigens and Matrix-M2 adjuvant measured by:~             -  Time to first clinical and/or virologic recurrence,~             -  Proportion of subjects who are recurrence free at 6 and 12 months after the last~               dose of vaccine,~             -  Lesion rate (percent of days with genital lesions present) during the~               post-vaccination swabbing periods.~        -  Evaluation of cellular and humoral responses to GEN-003 antigens.~      Additional objectives include:~        -  Assessment of the correlation between immune responses and change in viral shedding or~          impact on clinical disease as defined above.~        -  Determination of the recurrence rate in a subset of subjects not receiving suppressive~          antivirals throughout the study.~      Eligible subjects will enter a baseline period to collect anogenital swabs for 28 consecutive~     days prior to randomization. Each subject will receive up to 3 doses at 21 day intervals.~     Subjects will be followed for safety and immunologic response for 12 months following their~     last dose.~   "
111040|NCT02114047|"~     This study with evaluate blood flow in the lungs of patients prior to and after surgery for~     treatment.~   "
111041|NCT02114034|"~     The purpose of this prospective study is:~        -  to identify by cluster analysis the main phenotypes of severe asthma and factors~          involved in the severity,~        -  to determine the clinical and functional outcomes,~        -  to identify the factors associated with severe asthma from childhood to adulthood.~   "
111042|NCT02114021|"~     ABSTRACT:~      The aim of this study was to investigate the effect of betamethasone gel and lidocaine jelly~     (over tracheal tube cuff) compared with distilled water on the post intubation syndrome~     incidence. This study has not been carried out in Iran.~      99 patients of either sex undergoing elective surgery were recruited in a single blind~     randomized study. The patients, using randomization table, were divided into three groups.~     Anesthetics and medications used during surgery were similar for all the patients.~      For the all patients, the incidence of postoperative sore throat, cough and hoarseness of the~     voice in the different follow-up periods (1, 6 and 24 hours) based on the different types of~     medications were obtained.~   "
111043|NCT02114008|"~     To reduce the risk of aspiration for elective procedures, residual gastric volumes (RGV) have~     traditionally been minimized with overnight fasting. However, prolonged fasting can also have~     some adverse consequences and has been abandoned for some procedures in several patient~     populations with the exception of obese and/or diabetic patients. The aim of this study was~     to assess RGV in morbidly obese diabetic patients after traditional or abbreviated fasting.~   "
111044|NCT02113995|"~     Background To evaluate clinical results, insulin resistance and inflammatory response to~     trauma in morbidly obese patients undergoing laparoscopic Sleeve gastrectomy who received~     either traditional preoperative care or treatment following the ACERTO protocol.~   "
111045|NCT02113982|"~     This is a 4-stage, non-randomized, open-label, dose escalation and expansion, multicenter~     study. A cycle of therapy is 21 days. Stage 1 was a dose-escalation stage. During Stages 2-4,~     patients are treated at the MTD or maximum tested dose at which multiple DLTs are not~     observed during Stage 1.~   "
111046|NCT02113969|"~     Genital prolapse is a common condition (up 20%), affecting the quality of life. Treatment can~     be surgical or conservative using vaginal pessaries. These devices are introduced into the~     vagina aiming to reduces the prolapse.~      Pessaries have shown effectiveness in improving symptoms and quality of life. There are no~     randomized studies comparing them with surgery. This study design would be difficult to~     perform, because the inclusion criteria for both treatments are different. There are no~     currently standard protocols for the use of pessaries. This makes harder to widespread the~     usage of this conservative treatment.~      The aim of the investigators is to identify variables that influence the success of~     conservative management of genital prolapse at 1 year of follow up. Using these variables and~     an expert panel opinion the investigators will develop a standardized protocol for pessary~     management.~      Chile has a primary gynecological care system based midwives. Therefore having algorithms for~     pessaries usage becomes relevant. This algorithm can be implemented with basic training. This~     would increase the respond capacity, by the health care system to this disease, considering~     the scarce access to surgery.~      The investigators hypothesis is: It is possible to generate a standardized protocol of~     conservative management of symptomatic genital prolapse in patient's beneficiary of public~     health system in Santiago, Chile, using pessaries through a prospective cohort study based in~     the success of these devices with 1 year of follow up, measured with questionnaires of~     symptoms, quality of life and sexuality~   "
111047|NCT02113956|"~     The purpose of this study is to examine whether Guy2Guy (G2G), a text messaging-based healthy~     sexuality and human immunodeficiency virus (HIV) prevention program intervention for 14-18~     year gay, bisexual and queer men, is associated with HIV preventive behavior (e.g., condom~     use) compared to an attention-matched control group.~   "
111048|NCT02113943|"~     The aim of the current study is to examine the role of serotonin on the cognitive parameters~     of motivation. They are embedded in a conceptual framework of motivation that merges~     decision-making and reinforcement learning theories. Every action is conceived as path from~     one state to another. The different states are associated to different values (positive for~     rewards and negative for punishments), and the different actions to different costs (risk,~     effort and delay). The tasks are designed such that the sensitivity to the state and action~     parameters can be inferred by fitting computational models.The primary objective is to~     characterize the effect of Citalopram 30mg on reward sensitivity, assessed in an incentive~     force task, in which participants are asked to squeeze a hand grip to win monetary rewards.~     Secondary objectives are to characterize the effect of Citalopram 30mg on other cognitive~     parameters of motivation (assessed with a motivational battery that includes rating, choice~     and learning tasks).~   "
112212|NCT02098694|"~     The purpose of this study is to determine whether patients with spondyloarthritis are more~     satisfied with a physiotherapy-led outpatient clinic than usual care and whether there is a~     difference between patients in a physiotherapy-led outpatient clinic and those in usual care~     regarding disease activity, function and mobility.~   "
111049|NCT02113930|"~     Definition: Idiopathic CD4+ T lymphocytopenia (ICL) is an immune deficiency first described~     in 1992 and characterized by the US Centers for Disease Control (CDC) as absolute CD4+~     T-lymphocyte count < 300/mm3 or < 20% of total T cells on more than one cell count; no~     evidence of infection with HIV-1/2 or human T-cell lymphotropic 1/2 (HTLV-1/2); and lack of a~     defined immune-deficiency disease or therapy for lymphocytopenia. Epidemiologic, clinical and~     immunological characteristics of the syndrome were described in 1993 and ICL is now~     considered a heterogeneous syndrome not caused by an infectious agent. Patients with ICL may~     show opportunistic infections such as disseminated Cryptococcus neoformans infection,~     Pneumocystis jiroveci pneumonia and John Cunningham (JC) virus infection as a result of~     profound cell-mediated immune-response deficiency.~      Few studies have focused on the pathophysiology of ICL. CD4+ T-lymphocyte phenotyping~     revealed increased CD95 expression that could be responsible for excess apoptosis leading to~     lymphocytopenia. Moreover, the membrane expression of C-X-C chemokine receptor type 4 (CXCR4)~     was found impaired in T lymphocytes with ICL, and CXCR4 trafficking was improved with~     interleukin 2 (IL-2) treatment in some patients. Recently, mutations in nunc119, MAGT1 and~     Rag were found associated with CD4+ T lymphocytopenia. In a prospective study of 39 patients,~     CD8+ T lymphocytopenia (<180/mm3) and degree of CD4+ T-cell activation measured by human~     leukocyte antigen DR (HLA-DR) expression was found associated with poor prognosis.~      ICL is a heterogeneous disorder often associated with deficiencies in CD8+, CD19+, and/or NK~     cells. Long-term prognosis may be related to initial CD4+ and NK cell deficiency.~      Larger studies are needed to better identify the patients who might benefit from IL-2~     therapy. This is why the investigators conduct the Lympho-4 study, in which the investigators~     plan to include 200 patients with a suspected/proven diagnosis of ICL.~   "
111050|NCT02113917|"~     Different study of HLHa patients :~        -  Diagnosis criteria, because criteria are based on pediatric genetic studies.~        -  Physiopathological studies: genetic studies have demonstrated the role of CD8+ cells, in~          particular because they have a genetic defect affecting their cytotoxic functions in HLH~          pediatric. the aim is to establish if the same defect is found in both some or in all of~          HLHa patients. If this is the case, to then establish whether hypomorphic genetic~          mutations are responsible.~   "
111051|NCT02113904|"~     The main objective of this studies therapeutic : to determine the effect of Adalimumab~     (HumiraR) on clinical inflammatory manifestations of patients with Netherton syndrome after 3~     months of treatment , with a post treatment period follow-up of 3 months.~      Second objectives are To evaluate the safety of Adalimumab in the context of NS To evaluate~     the improvement of the quality of life at 3 months To evaluate the improvement of pruritus~     and pain in the patients To study markers of inflammatory and allergy in NS prior and after~     treatment Benefit of the study An improvement by at least 20% of the cutaneous signs in these~     patients who suffer from a genetic incurable, chronic, painful and very afflicting disease~     would be of a great help for these patients. NS is a major source of social exclusion.~      Risks They are inherent to the risks of biotherapies, especially for an anti-TNF therapy,~     they comprise a risk of infection. Cutaneous infections occur mainly during infancy, and we~     have therefore chosen to treat patients over 4 years of age in this study.~      A close clinical surveillance will be set up (initially every week during the first month of~     treatment, then every month). This will represents a large number of visits but will provide~     a high level of security.~      Benefits/risks ratio In the absence of curative treatment for these patients with a severe~     genetic skin disease, the benefits/risks ration clearly appears to be in favour of an~     expected benefit.~   "
111052|NCT02113891|"~     Advances in renal transplantation have increased life-expectancy in patients with end-stage~     kidney disease. Conventional immunosuppressive drugs prevent efficiently early allograft~     losses due to T-cell mediated rejection. However, emerging data suggest that the majority of~     late kidney failures may be attributable to antibody-mediated rejection (AMR), which poorly~     responds to the currently available therapeutics. Complement-fixing donor-specific anti-HLA~     antibodies are associated with the worst outcome in keeping with the well-established role of~     the complement in AMR pathogenesis. Eculizumab, the first licenced complement blocker, has~     been found efficient in reducing the occurrence of AMR lesions in highly sensitized patients.~     A few reports also suggest that complement blockade may be of great value as salvage therapy~     for graft-threatening severe AMR. However, no information is available in the literature~     about the interest of complement blockade in curbing the progression of subclinical acute AMR~     to chronic AMR.~      The purpose of this study is to determine whether complement blockade with eculizumab is~     effective and safe in the treatment of subclinical AMR in sensitized kidney transplant~     recipients.~      Despite appropriate therapies, up to 75% of patients having received a renal transplant with~     preformed donor-specific antibody display subclinical AMR on their 3-month protocol biopsy.~     Subclinical AMR is defined by histological lesions of AMR concomitant with stable graft~     function. Moreover, the extent of these lesions at 3 month post-transplant correlates with~     the occurrence of irreversible scars and chonic antibody-mediated rejection on the 12-month~     biopsy.~      This study aims to explore the efficacy and safety of eculizumab in patients exhibiting~     subclinical AMR on their 3 month-post-transplant biopsy, to reduce or even normalize~     microcirculation inflammation, and to prevent chronic rejection (transplant glomerulopathy)~     on the 12 month-screening biopsy. Eculizumab-treated patients will be compared with~     historical controls, matched for the lesions on the 3 month biopsy.~   "
111053|NCT02113878|"~     This research study is evaluating a drug called buparlisib (BKM120) as a possible treatment~     for locally advanced head and neck squamous cell cancer.~   "
111054|NCT02113865|"~     The aim of this study is to establish a clinical score panel based on clinical, molecular and~     genetic parameters that allow us to stratify and obtain an early detection of patients with~     an increased risk of developing hepatocellular carcinoma (HCC).~   "
111055|NCT02113852|"~     This is an epidemiological,multicenter study of genomic and expression profiles of patients~     with newly diagnosed NSCLC.Two hundred and fifty NSCLC patients who fulfill the criteria are~     to be recruited by investigational sites.Approximately 100 of them will be from~     retrospectively collected samples with detailed clinical and 2-year follow-up information~     after surgeries.The demographics,cancer/adjacent normal tissue and matched blood sample will~     be collected after the patient had provided informed consent.All tissue samples will be~     analyzed for somatic mutations by exome deep sequencing,mRNA expression profiling by RNA~     sequencing and chromosome copy number variation by SNP array at the designated laboratories.~   "
111056|NCT02113839|"~     The perception of breathlessness varies significantly among COPD patients with similar~     severity of airflow limitation; those with poorer perception report less exacerbations as~     compared to those with frequent exacerbations.~      Cross-sectional comparison of breathlessness perception in COPD patients with frequent~     exacerbations or without frequent exacerbations.~      To assess Breathlessness Perception the investigators will increase the ventilatory demand~     of the patients by CO2-rebreathing method.~   "
111057|NCT02113826|"~     Alveolar soft part sarcoma (ASPS), a rare subset of STS (<1%) harbors t(X;17)(p11;q25)~     translocation and produces resultant ASPL-TFE3 fusion protein. Due to its nature of high~     expression of angiogenic factors, sunitinib and cediranib produced overall response rates of~     55% and 43%, respectively. However, the efficacy of pazopanib is unknown in metastatic ASPS.~   "
111834|NCT02103608|"~     This is a clinical study to determine the efficacy and safety of the Glide, hair removal~     photo-depilation device, for removing facial hairs. During the first stage, the subjects will~     perform up to 6 face treatments, two weeks apart. The treatment's safety and efficiency will~     be evaluated at 4 weeks of after last treatment and at 12 weeks after last treatment.~   "
111059|NCT02113800|"~     The study is designed as an open-label, prospective, single arm, multicenter study of~     everolimus in histologically confirmed, neuroendocrine carcinoma G3 /neuroendocrine tumor G3~     after failure of first-line platin-based chemotherapy (open-label pilot study).~      The aim of this study is to provide a second line therapy to patients with any type of~     platinum based first line chemotherapy, to gather data on disease control rate and~     progression free survival.~   "
111060|NCT02113787|"~     The purpose of the study is to prove the bioequivalence of brand and generic topiramate.~   "
111061|NCT02113774|"~     The investigators hypothesize that antibiotic therapy for asymptomatic bacteriuria in renal~     transplant patients does not have impact on the development of symptomatic urinary tract~     infection (UTI) or progression of renal impairment in patients during the first year after~     transplantation.~   "
111062|NCT02113761|"~     RATIONALE / CONTEXT The ECG records the electrical activity propagating along cardiac cells~     (from the atria to the ventricles). The standard 12 ECG leads placed on the chest measure the~     global activation of the heart and do not have the ability to detect small-scale disturbances~     or to pinpoint ectopic activity. By the 1960s, multiple electrodes were placed around the~     chest to try to understand the complexity of the distribution of electrical activity in~     relation to the single cardiothoracic geometry of each individual. The safety of this method~     is similar to the ECG but its superiority has been demonstrated by the detection of anomalies~     imperceptible to the standard ECG. The accuracy of the technique in localizing rhythm~     disturbances is on the order of 5 mm.~      OBJECTIVES Main objective: To evaluate the utility of noninvasive mapping during persistent~     AF electrophysiology procedure~      Secondary objectives:~        1. Compare the effectiveness of noninvasive mapping compared to conventional standard of~          care methods for AF mapping and ablation procedure.~        2. Evaluate the absence of recurrence of persistent AF after a follow up of 12 months after~          the procedure during a scheduled hospitalization.~      DIAGRAM OF RESEARCH European Diagnostic Study, feasibility, non-randomized, multi center~      RESEARCH PROCEDURES A trained clinical specialist places 252 dry gelled ECG electrodes on the~     patient's torso. The 252 ECG electrode array is hooked up to the CardioInsight system and~     body surface ECG recordings are made during the patient's arrhythmia. The patient is then~     sent to the radiology department for a CT scan (no contrast) to image both the heart and~     electrodes on the patient's torso. A trained clinical specialist from CardioInsight then~     segments the CT DICOM images from the CT scan to obtain epicardial anatomy and establish~     heart-torso geometry.~      The electrograms are processed by the system to produce movies of fibrillatory activity (both~     focal activity, and rotor activity).~      PROCEDURAL ENDPOINTS Primary endpoint: Acute AF termination to atrial tachycardia or sinus~     rhythm~      Secondary outcome criteria:~        -  Reduction in RF time compared to standard of care (historical control - comparable~          patient population)~        -  Reduction in procedure time compared to standard of care (historical control -~          comparable patient population)~        -  Freedom from persistent AF at the end of the 12 months F/U period STUDY SIZE~      The sample size was estimated at 100 patients, with up to 20 patients per center STUDY~     CENTERS 8 Centers :~        -  Brugmann - Brussels (Belgium)~        -  Clinique Pasteur - Toulouse (France)~        -  Medizinische Klinik und Poliklinik - Mainz (Germany)~        -  University ed Herzzentrum Freiburg Bad Kozingen (Germany)~        -  Deutsches Herzzentrum München, Munich (Germany)~        -  Kerkhoff Klinik, Bad Nauheim, (Germany)~        -  Sint-Jan Sint-Franciscus Xaverius, Brugge (Belgium)~        -  Clinique Ambroise Paré, Paris, France~      EXPECTED OUTCOME In patients referred for ablation of persistent AF, ECG mapping data will be~     correlated to the invasive procedure. It is expected that procedure time will be~     statistically shorter and total RF energy delivery is expected to be smaller than that of~     standard of care for AF treatment.~   "
111063|NCT02113748|"~     This randomized control trial will investigate whether a modality that generates more~     contractile muscle fatigue with lower ventilatory requirements render better results after a~     12-week exercise training program in subjects with COPD.~      Subjects will be randomized to either exercise in a training program including downhill~     walking or to exercise in a training program including conventional walking.~   "
111064|NCT02113735|"~     This study is being performed to evaluate the potential efficacy and safety of Acthar as a~     treatment for moderate-severe Acute Respiratory Distress Syndrome (ARDS). Approximately 210~     subjects will be randomized to 1 of 6 possible treatment groups in a 3:2:3:2:3:2 ratio. Study~     medication (SM) will be administered via subcutaneous (SC) injection for 4 weeks using a~     blinded gradually tapering regimen, and subjects will be followed for 60 days~     post-randomization.~   "
111065|NCT02113722|"~     The purpose of this study is to determine whether the incidence of recurrent life threatening~     ventricular arrhythmias in patients with an implanted cardiac defibrillator (ICD) can be~     reduced if a surgical left stellate ganglionectomy is performed.~   "
111066|NCT02113709|"~     Objective: To find out how much visual improvement is possible in severe amblyopia using~     full-time occlusion therapy with an eye patch and to see if improvement is influenced by the~     patient's age.~      Methods: An interventional clinical trial of 115 consecutive cases with unilateral, severe~     amblyopia was conducted at a tertiary referral center from Jan 2010 to Oct 2012. Patients~     were divided into three age groups: 3-7 years (n= 38), 8-12 years (n=41), 13-35 years (n=36).~     After a complete ophthalmological examination by a single ophthalmologist, cases with organic~     visual loss were excluded; cases with previous part-time occlusion therapy that had failed~     were included in the study. Patients were given optimal refractive correction for a month,~     followed by full-time occlusion therapy along with near visual activities for 3-4 hours/day.~     The therapy was continued until maximum visual recovery was achieved (6/6 Snellen's). Therapy~     was gradually reduced and stopped. Patients were followed-up regularly for the next 18~     months.~   "
111067|NCT02113696|"~     Ingestion of capsules of omega 3 EPA and DHA, with 1.8 g of EPA and 1.2 g DHA for morbidly~     obese patients, will improve the inflammatory status? C-reactive protein? Weight?~   "
111068|NCT02113683|"~     The purpose of this study is the validation of MMS test to detect active tumor growth in~     different cancer types before and after therapy, as well as in the course of therapy and for~     subsequent relapse control compared to standard methods (clinical examination, imaging, tumor~     markers). It should be consider whether the MMS test has comparable diagnostic accuracy, and~     thus can replace more expensive or invasive procedures in future.~   "
111069|NCT02113670|"~     More than 11 million women in the United States suffer from stress urinary incontinence~     (SUI), the involuntary leakage of urine during everyday activities that put temporary stress~     on the abdomen and bladder, such as laughing, coughing, and walking. For women with SUI, this~     pressure often causes urine to leak involuntarily. SUI affects women of all ages including~     young mothers, pre-menopausal women, and seniors, and can result in significant emotional~     distress. Current solutions for SUI include disposable pads, behavioral treatment (pelvic~     floor physical therapy) and surgical intervention. Patients with SUI who failed conservative~     treatment and wish to be further treated by a surgery may require further work-up by~     urodynamic study in which abdominal leak point pressures (ALPP) defined and reflect the~     severity of SUI.~      There is continuous need to develop less invasive treatments for SUI that could minimize the~     use of pads, could be an alternative to painful, costly surgical procedure. The Trendlines~     Group lab solution is a non-surgical alternative in the treatment of SUI. The concept of the~     future treatment solution is based on simple physics: injecting a small amount of air into~     the urinary bladder, which eliminates or greatly reduces involuntary urinary leakage. The air~     bubble acts as a shock absorber to reduce the temporary pressure increase in the bladder~     that causes urinary leakage. The concept for the new treatment has been tested in a lab~     environment using lab jig tests and pig urinary system (bladder and urethra). The lab tests~     showed significant improvement in the bladder pressure when the treatment was implemented by~     suspending the stress pressure to a level that will not cause urine leakage.~   "
111070|NCT02113657|"~     The goal of this clinical research study is to study the impact of ipilimumab on the immune~     system of patients currently receiving hormone therapy. The safety of these drug combinations~     will also be studied.~   "
111071|NCT02113644|"~     The aim of Prevent CardioKids is to evaluate to what extend disturbed vascular function~     markers are already present in children of different weight categories and whether these are~     age dependent. Also differences - and relationships - between vascular function measurements~     and plasma biomarkers between lean and overweight/obese children will be compared.~   "
111072|NCT02113631|"~     1. The primary objective is to study the comparative effectiveness and tolerability of~          boceprevir vs. telaprevir in HCV treatment, within the VA population.~        2. The secondary objective:~             -  Resource use: recording of differences in resource use, such as direct costs (e.g.,~               drug acquisition costs) and other indirect cost (e.g., staff utilization etc.) as~               the study will not only derive data by comparing those two drugs but also study the~               effect on different treatment lengths.~   "
111073|NCT02113618|"~     To purpose of the present study is to investigate the feasibility and efficacy of a~     computerized working memory training in improving cognitive functioning and alcohol use~     outcomes, in individuals with alcohol use disorders.~   "
111074|NCT02113605|"~     The purpose of the trial is to develop a treatment protocol to be used in trials studying~     internet-delivered CBT for children with functional gastrointestinal disorders (FGID). The~     study size is not based on power calculations but the estimated sample necessary to develop a~     treatment protocol. This study will include 20-30 children with FGID and their parents who~     will be treated individually (face-to-face). The treatment consists of 10 weekly sessions of~     exposure-based CBT. The study uses a pre- post-design with no control group.~   "
111075|NCT02113592|"~     The overall aim of this study is to adopt an integrative rehabilitation approach for helping~     patients adopt self-management skills for managing chronic pain, limiting use of opioid~     medications, and identifying exacerbating factors amenable to treatment (e.g., depression,~     sleep problems) that is feasible and sustainable within the primary care setting.~   "
111076|NCT02113579|"~     This study is for people with sensitive teeth and involves going to the dentist for 4 visits~     over 6 weeks. At each visit the dentist will look at the mouth, teeth, tongue and gums of~     participants, and check for sensitive teeth.~      During the first 2 weeks, participants will brush their teeth 2 times a day with the fluoride~     toothpaste provided.~      Then, if they qualify to continue in the study, participants will be assigned to one of two~     treatment groups for the last 4 weeks. Both groups will use assigned toothpaste currently~     sold on the market. Both groups will each have an investigative mouth rinse to use as well.~     Participants will have an equal chance of being assigned to any one of the three groups.~      For the next 4 weeks, participants will use their assigned products according to the~     directions provided. At Visit 1, participants will be supervised while they brush their teeth~     to ensure they understand the directions. They will also have supervised use of the products~     at Visit 2.~      Results will be analyzed to assess whether the mouthwashes help to reduce tooth sensitivity~     during the study.~   "
111077|NCT02113566|"~     The hypotheses to be tested are: Efficacy: Ibuprofen will be more effective than the Placebo~     in relieving muscle pain/soreness over 48 hour post-dosing with study medication. Safety:~     There will be no or minimal increased incidence of adverse events (AEs) with Ibuprofen versus~     and both will be well tolerated.~   "
111078|NCT02113553|"~     This is a multicentre, prospective study willing to evaluate AMH levels changes in response~     to chemotherapy plus GnRHa.~      In the present study we propose to determine AMH levels in breast cancer patients, aged~     <40yrs receiving adjuvant chemotherapy and ovarian suppression by means of GnRHa with the aim~     to assess the role of AMH as surrogate marker of the preservation of ovarian reserve exerted~     by GnRHa.~   "
111079|NCT02113540|"~     As the effect of statin use before the angiography to prevent contrast induced nephropathy~     (CIN) is not well-known, the aim of the current study is to assess the effect of atorvastatin~     on prevention of CIN in patients undergoing coronary angiography.~   "
111080|NCT02113527|"~     Rome III criteria defined functional dyspepsia (FD) as the presence of symptoms from the~     gastroduodenal region in the absence of any organic, systemic or metabolic disease that is~     likely to explain the symptoms. FD can be further subdivided into two diagnostic categories:~     postprandial distress syndrome (PDS) and epigastric pain syndrome (EPS).~      Disorders of gastric electric activity and abnormal gastric emptying are probably actively~     involved in the FD onset. Different noninvasive procedures may be applied in order to~     evaluate the gastric motor functions such as 13C breath testing and cutaneous~     electrogastrography. Besides, different gastrointestinal peptides (i.e. CCK, peptide YY,~     Neurotensin, Somatostatin, Leptin, Ghrelin, Motilin, Gastrin, Pepsinogen I and II) are~     involved in the control of gastroduodenal motility.~      Aims of the present study are: 1) to evaluate the GI peptide circulating concentrations, the~     gastric electrical activity and gastric emptying time by applying noninvasive procedures in~     patients suffering from functional dyspepsia and 2) to test whether a significant difference~     exists between the two diagnostic categories of meal-induced dyspeptic symptoms~   "
111081|NCT02113514|"~     Community Awareness, Resources and Education (CARE) Project - Project 3 will determine if~     Appalachian women have unique risk factors for an abnormal Pap smear that might contribute to~     the increased risk of cervical abnormalities, specifically cancer, in their communities.~   "
111082|NCT02113501|"~     Non-muscle invasive bladder cancer of High Grade stage T1 (HGT1), has up to 20% risk of~     progression to invasive disease. Because the depth of substaging seems to identify two~     separate groups with different progression risk (HighGradeT1a and HighGradeT1b), we design a~     differential treatment strategy for each group. The main hypothesis is that HighGradeT1a~     bladder cancer can spare a second endoscopic procedure.~   "
111083|NCT02113488|"~     Our aim was to identify the causes non-attendance at scheduled appointments at the Clinical~     Medicine Outpatient care system at the Italian Hospital of Buenos Aires (HIBA).~   "
111084|NCT02113475|"~     Deep Venous Thrombosis affects more than 350,000 individuals each year in the U.S.The~     Registry will track patient outcome and quality of life over 60 months for treatment with~     anticoagulation and elastic compression stockings and catheter-directed thrombolysis (CDT) in~     accordance with current treatment guidelines .~   "
111085|NCT02113462|"~     The Triglycerides (TG) to High Density Lipoprotein Cholesterol (HDL-C) ratio is a feature of~     insulin resistance and an independent predictor of cardiovascular risk. The investigators~     aimed to evaluate the relationship between TG/HDL-C ratio and the endothelial functions in~     patients with CKD.~   "
111086|NCT02113449|"~     Carbon dioxide (CO2) is a naturally occurring gas that readily diffuses across body tissues~     and membranes. Data from earlier clinical studies conducted in 975 subjects with allergic~     rhinitis have shown that nasally administered CO2 may provide relief of the associated~     symptoms. Symptom relief has been shown to occur as soon as 10 minutes after administration,~     and may persist for four to six hours.~      This study aims to assess the consumer appeal of a prototype CO2 delivery device, as well as~     evaluate its perceived effectiveness for nasal congestion. Properly consented subjects who~     qualify and choose to participate in the clinical study will be administered nasal CO2 under~     medical supervision, wait a period of 1 hour in clinic, and then be dispensed a device for~     self-treatment at home. Subjects will return to the clinic on day 7 for final evaluation and~     completion of assessment questionnaires.~   "
111835|NCT02103595|"~     German Multi-centered, randomized, crossover study in diabetic patients evaluating two~     infusion sets under real life conditions at home. Subjects will be randomized to use one of~     the infusion set devices during the first period of 4 weeks, and be switched to the other~     infusion set for the second period of 4 weeks.~   "
111087|NCT02113436|"~     This study is a multicenter, stratified, randomized, active control, double-blinded,~     parallel-group comparative study with an open-label extension period. The study is designed~     to evaluate the efficacy and safety of FP/ SLM HFA MDI 50/25 microgram (mcg) one or two~     inhalation twice daily (BID) for 8 weeks in comparison with FP HFA MDI 50 mcg one or two~     inhalation BID, in 6-month to 4-year-old Japanese patients with bronchial asthma. The study~     is also designed to evaluate the safety of long-term treatment of FP/ SLM HFA MDI 50/25 mcg~     one or two BID for 16 weeks.~      The subjects meeting the eligibility criteria will enter the run-in period of 2 weeks and~     receive FP 50 mcg 1 or 2 inhalation bid (FP 100 or 200 mcg/day), before randomization. The~     subjects under 2 years of age at Visit 1 will receive only 1 inhalation bid during the run-in~     period. The subjects who meet the eligibility criteria for randomization will be stratified~     according to their age (<2 or >=2 year-old) at Visit 1 and randomized to one of the two~     treatment groups.~      The total duration of participation in the study will be 10 weeks for a comparison period~     completion and 27 weeks for a completion.~   "
111088|NCT02113423|"~     The hypothesis of the study is to address the efficacy and toxicity profile of aforementioned~     four modalities for rT1-2 NPC.~      Characters of the patients:~        -  list item one: 168 patients, median age 48 years (range 16-75 years） proven rT1-2 NPC~          were diagnosed~        -  list item two: Treated with four different irradiation modalities(3D-CRT,IMRT, BT , BT~          Combined 3D-CRT or IMRT).~        -  list item three: Median time to recurrence was 30 months (range 1-180months). The median~          follow-up time was 28 months (range, 4-135 months).~   "
111089|NCT02113410|"~     The current study is a randomized controlled clinical trial to test the feasibility of~     recruiting, randomizing, and having older adults with osteoarthritis (OA) adhere to and~     safely complete the Sit 'N' Fit Chair Yoga program and the HEP program (primary objective).~     Secondary objectives of the study are to determine the effect of the Sit 'N' Fit Chair Yoga~     Program to reduce levels of pain; improve physical function, psychosocial function, and life~     satisfaction in adults over 65 years of age who are unable to participate in standing~     exercise. Participants at two sites will be randomly assigned to either the intervention~     group (Sit 'N' Fit Chair Yoga) or attention control group (Health Education Program). Data~     collectors will be blinded to group assignments. Data will be collected prior to the~     intervention (baseline), after 4 weeks, and after 8 weeks. Follow-up data will be collected~     after 1 month and after 3 months after completion of the intervention to measure the extent~     to which effects of the intervention continue. Evaluations will include physical measures and~     self-report measures.~   "
111090|NCT02113397|"~     The purpose of this study is to characterize bacterial diversity and richness in the sputum~     of cystic fibrosis patients treated with every-other-month TOBI™ Podhaler™ and continuous~     alternating therapy with TOBI™ Podhaler and colistimethate (Colistin).~   "
111091|NCT02113384|"~     During the course of tumor growth and possibly by manipulation during the surgical procedure,~     cells from rectal tumors may be shed into the peritoneal cavity. Such cells may give rise to~     local recurrence or contribute to the formation of metastatic disease, specifically in the~     form of peritoneal carcinomatosis. Detection of cancer cells in the peritoneal cavity at the~     time of surgery might therefore be of value for prediction of disease recurrence with~     subsequent prognostic implications for these patients. In this study the investigators aim to~     determine the presence of exfoliated tumor cells in peritoneal lavage samples from patients~     undergoing surgery for LARC.~   "
111092|NCT02113371|"~     The current project is a safety and health intervention for home care workers conducted~     within the Oregon Healthy Workforce Center (OHWC), a NIOSH Center of Excellence in Total~     Worker Health.~      The objective of this five-year project is to create sustainable health and safety~     communities of practice within a population of typically isolated home care workers. The~     intervention is a team-based, peer-led scripted curriculum that integrates health promotion~     and protection topics, as well as proven elements of social support groups for caregivers.~     The investigators hypothesize that this intervention will increase measures of experienced~     community of practice, well-being, and diet, exercise, and safety behaviors, as compared to a~     usual practices control condition.~   "
111093|NCT02113358|"~     Fluid management during neurosurgery presents a special clinical agenda. Volume overload can~     have detrimental effects on intracranial pressure by increasing either cerebral blood volume~     or hydrostatically driven cerebral edema formation. On the other hand, an overt restrictive~     fluid strategy may risk hemodynamic instability.~      Recently, dynamic fluid responsiveness parameters such as stroke volume variation (SVV) have~     been shown as a more precise parameters for fluid management including in neurosurgical~     patients. The threshold of SVV is reported about 10-15%. In this study, the investigators aim~     to using two SVV threshold to conduct intraoperative fluid therapy for craniotomy.~     Randomization will be generated by computer sampling. One of the two groups of patients will~     be managed with fluid bolus to keep intraoperative SVV <10% presenting the normovolemia~     group. The other group of patients will be kept intraoperative SVV <18% which is slightly~     above previously reported SVV threshold upper limit. The second group thus presents the~     restrictive group. Clinical outcomes, laboratory analysis including S100-B for neuronal~     damage and neutrophil gelatinase-associated lipocalin (NGAL) for acute kidney injury, will be~     compared.~   "
111094|NCT02113345|"~     The purpose of this research is to explore the relationship of metamemory and memory of~     elders and to evaluate the effectiveness of a metamemory cognitive intervention on elders~     with mild cognitive impairment and low memory self-efficacy.~   "
111095|NCT02113332|"~     Liraglutide, a GLP-1-analogue has been shown to be an effective treatment option in patients~     on oral anti-diabetes therapy with beneficial effects on both glycaemic control and weight.~     However, to date there are no clinical trials of liraglutide added to insulin therapy, a~     population of patients generally having worse glycaemic control and weight gain. In clinical~     guidelines, use of multiple daily insulin injections (MDI) is usually the final therapeutic~     option for type 2 diabetic patients.~      The primary study aim is to evaluate whether the addition of liraglutide, compared to~     placebo, reduces the HbA1c level for overweight and obese type 2 diabetes patients with~     inadequate glycaemic control treated with multiple daily insulin injections (MDI). MDI is~     defined as treatment with any basal insulin combined with separate meal time insulin~     injections before the main meals, i.e. an insulin regimen with premixed insulin is not~     considered as MDI.~      The planned study duration is 24 weeks and includes 120 patients at 15 centers in Sweden.~   "
111097|NCT02113306|"~     A recent study with rats showed that electrical stimulation of the vagus nerve (VNS)~     facilitates extinction of fear (Pena, Engineer, & McIntyre, Biological Psychiatry, 2013). The~     hypothesized mechanism is that VNS both enhances memory consolidation (by increasing~     noradrenergic neurotransmission) and reduces anxiety (thus: preventing fear responses to the~     CS which may re-consolidate the fear memory). The effect was only apparent when VNS occurred~     during exposure of the fear conditioned stimulus (CS), and not when stimulation was given~     immediately following exposure. These results may have implications for the treatment of~     anxiety disorders in humans. However, until recently, the only means to investigate the~     effects of VNS on human fear learning would have required the invasive implantation of vagus~     nerve stimulators. This has fortunately changed, as a non-invasive transcutaneous VNS device~     has been approved for use in the E.U. for the treatment of psychological disorders.~      This study proposes to use a t-VNS to investigate its effects on fear learning and extinction~     in (healthy) humans. Previous research has only investigated the effects it has on human mood~     and memory. The results obtained suggest that it reduces negative affect and enhances memory,~     findings which are consistent with those reported for rats. It is thus reasonable to expect~     that t-VNS will facilitate the extinction of fear in humans.~      The present study aims to answer the following research questions:~      Does t-VNS during extinction training:~        1. accelerates extinction curves~        2. reduces spontaneous recovery of previously extinguished fear~        3. reduce re-acquisition of fear~        4. reduce generalization of fear to other stimuli that resemble the CS+?~        5. facilitates the generalization of inhibitory learning to stimuli that resemble the CS-?~   "
111098|NCT02113293|"~     This study is intended to investigate the tolerability and the safety of Cyclosporine A~     containing CyclASol® eye drops compared to Placebo (vehicle) in a cohort of healthy~     volunteers. Subjects will be randomly assigned to dosing with CyclASol® eye drops or Placebo~     (vehicle) in the first part (first period) of the study, and switched to the alternative~     dosing in the second part (second period) of the study. An ophthalmological assessment of the~     eyes will be performed, and a questionnaire will be issued in the beginning and after each~     dosing. Additionally physical examinations, safety laboratory and ECGs will be performed, and~     blood samples will be analyzed for Cyclosporine A and Placebo (vehicle).~   "
111099|NCT02113280|"~     Patients with wear and tear in their knees (osteoarthritis) are often referred to orthopaedic~     surgeons following a sudden worsening of pain and mechanical symptoms (grinding, locking,~     giving way) in their knee due to tears of their meniscal cartilages. These tears are~     described as degenerative as they are not usually caused by a single injury but rather~     accumulation of wear and tear. It is not clear from the current available evidence what the~     best treatment for these patients is. Their underlying arthritis is not bad enough to require~     joint replacement yet and they were usually managing well with minimal problems from their~     knee until experiencing the meniscal tear. However, some of their symptoms are likely to be~     due to the arthritis rather than just the tear. Current treatment for these patients is~     usually in the form of conservative treatment with physiotherapy and supervised exercise or~     using arthroscopy (key-hole surgery) to trim the damaged area of the meniscus. We know from~     previous research that most of these patients will improve over time to some extent but it is~     not clear whether a greater improvement can be expected following surgery and if so, whether~     this applies to all patients with this problem or not.~      Our study is intended to compare the outcome of patients with proven degenerative meniscal~     tears imaged on MRI scans, when they are assigned to arthroscopy followed by supervised~     exercise or supervised exercise alone. They will be randomly assigned and the outcome will be~     assessed using patient-completed questionnaires (Knee Outcome Osteoarthritis and injury Score~     [KOOS], SF12, visual analogue score for pain) and whether the patients go on to require~     further surgery during the period of the trial. The patients will be assessed at baseline, at~     6 weeks, 6 months, 12 months and 24 months.~   "
111100|NCT02113267|"~     Background:~      Eosinophilic esophagitis ( EoE ) is a disease entity which has been properly recognized only~     within the past two decades.(1) A prevalence of nearly 1% means that almost 20,000 people in~     the Region of Western Sweden may be affected.(2 ) The main symptom is swallowing difficulty~     and food may be stuck, which typically require acute hospital care with operational action~     under general anesthesia.( 3,4 ) The standard treatment today is local treatment with~     steroids by mouth several times a day for a few weeks.( 5 ) In adults and large teenagers,~     there is only one randomized study which has shown that budesonide has a significant effect~     exaggerating that of placebo. However, the main end-point in this study was the degree of~     tissue inflammation.(6) In a separate study using validated questionnaires , we have shown~     that patients with EoE have distinct organ-specific symptoms and a lowered quality of life .~     These symptoms nearly disappeared, after treatment with mometasone furoate. However, as that~     study was not randomized or placebo controlled no causal conclusions could be drawn regarding~     the treatment effect, but the method of validated questionnaires proved sensitive to changes~     in symptomatology.(7) Purpose The primary purpose of this study is to evaluate the effect of~     local steroid treatment with mometasone furoate on swallowing problems in patients with EoE .~     Secondarily, to evaluate the effect on patient quality of life and the presence of side~     effects.~   "
111101|NCT02113254|"~     The Age Macular Degeneration (AMD) is the first cause of blindness in industrialized~     countries. The macular pigment (lutein and zeaxanthin) could play an important role in the~     arisen of the AMD. The food supplementation by corn with strong concentration in macular~     pigment could increase the density of the macular pigment. This could, in the future,~     represent a strategy of prevention of the AMD. The main objective of this study is to detect~     an increase of the macular pigment density after the consumption of this corn at healthy~     volunteers.~   "
111102|NCT02113241|"~     The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult~     population suffers the disease.~      Dapagliflozin is an inhibitor of the sodium-glucose co-transporter SGLT2 in the kidney and is~     a novel treatment for diabetes type 2. Some studies indicate that SGLT2 inhibitors have~     benefits on blood pressure, triglycerides levels and help to raise the levels of high density~     lipoproteins cholesterol (c-HDL).~      The aim of this study is to evaluate the effect of dapagliflozin on metabolic syndrome,~     insulin sensitivity and insulin secretion.~      The investigators hypothesis is that the administration of dapagliflozin modifies the~     metabolic syndrome, insulin sensitivity and insulin secretion.~   "
111104|NCT02113215|"~     Intrahepatic and intramyocellular lipid concentrations are elevated in elderly individuals~     relative to young people, despite no significant difference in fasting plasma TAG~     concentrations. Our general hypothesis is that the increase in intrahepatic fat with age~     results from reduced VLDL turnover, and therefore elderly individuals in this study will~     display lower VLDL turnover rates than young individuals. The aims of this study are a) to~     compare VLDL turnover in young and elderly individuals, and b) to compare a bolus method and~     a constant infusion method of assessing VLDL turnover.~   "
111105|NCT02113202|"~     There is a need for better visualization of polyps during surveillance endoscopy in patients~     with hereditary colon cancer syndromes like Familial Adenomatous Polyposis (FAP) and Lynch~     Syndrome (LS), to improve the adenoma detection rate. Optical molecular imaging of adenoma~     associated biomarkers is a promising technique to accommodate this need. The biomarker~     Vascular Endothelial Growth Factor (VEGF) is overexpressed in adenomatous colon tissue versus~     normal tissue and has proven to be a valid target for molecular imaging. The University~     Medical Center Groningen (UMCG) developed a fluorescent tracer by labeling the VEGF-targeting~     humanized monoclonal antibody bevacizumab, currently used in anti-cancer therapy, with the~     fluorescent dye IRDye800CW. The investigators hypothesize that when bevacizumab-IRDye800CW is~     administered to patients, it accumulates in VEGF expressing adenomas, enabling adenoma~     visualization using a newly developed near-infrared (NIR) fluorescence endoscopy platform~     (NL43407.042.13). This hypothesis will be tested in this feasibility study, next to the~     determination of the optimal tracer dose.~   "
111106|NCT02113189|"~     The purpose of this study is to investigate the impact of a specifically designed leg brace~     on walking endurance in individuals with Parkinson's disease.~   "
111107|NCT02113176|"~     The purpose of this study is to determine the safety and efficacy of a drug minocycline in~     improving outcomes at 3 months after rupture of an aneurysm in the head.~   "
111108|NCT02113163|"~     The primary objective of the study is to contrast the pharmacokinetic profiles of metformin~     and EPA delivered separately as co-administered products (metformin hydrochloride or~     Glucophage and icosapent ethyl or Vascepa) and together as the solid dose form (metformin~     eicosapentaenoate or TP-101) under fasted and fed conditions. A secondary objective is to~     evaluate the safety and tolerability of single and repeat single doses of TP-101.~   "
111109|NCT02113150|"~     In this prospective, randomized, clinical trial, we have investigated the effects of~     ketamine-based and remifentanil-based anesthetic protocol on perioperative serum cystatin-c~     levels, and creatinine and/or cystatin-c based eGFR equations in terms of acute kidney injury~     in CABG surgery.This study was approved by the Ethics Committee of Hospital and all patients~     were informed and gave written consent. Patients scheduled for elective CABG with~     cardiopulmonary bypass. Patients were randomly allocated to anesthesia with~     remifentanil-propofol-midazolam (RPM) group or ketamine-propofol-midazolam (KPM) group. Blood~     samples were obtained before induction of anesthesia (baseline), at the end of the operation,~     and postoperative days 1, 2, and 4.~   "
111110|NCT02113137|"~     The purpose of the study is to evaluate the effect of various oral hygiene procedures on~     reduction of oral malodor.~   "
111111|NCT02113124|"~     Years after a suffering a brain injury, individuals remain in a physically and cognitively~     impaired state. The investigators believe that the concentrations of amino acids in the blood~     are chronically altered and yield negative effects on the individuals health. Preliminary~     data has shown significantly lower concentrations of amino acids in serum samples from the~     TBI population, these diminished levels of amino acids may be due to changes in the~     microbiome. Understanding these changes will help guide rehabilitative services for this~     population. Individuals with a chronic brain injury will donate samples of blood, oral~     tissue, and fecal matter to be compared to that of non-injured individuals. Genetic~     information from the hosts will be striped and discarded; participant's genetic information~     will not be retained. To better understand changes in the microbiome, any history of~     antibiotics and probiotics will be assessed.~   "
111112|NCT02113111|"~     The study aims to investigate~        -  if a 7 day therapeutic fasting regimen will affect self-efficacy of patients with~          chronic diseases~        -  the effects of fasting on physical and mental well-being, quality of life and body~          awareness/image~        -  the association between patients characteristics and the perceived health benefit after~          fasting~        -  the association between Diagnosis according to traditional Chinese medicine and physical~          and mental well-being during the course of fasting~        -  experiences and perceptions of patients during fasting therapy~   "
111113|NCT02113098|"~     The purpose of this study is to determine whether the add load on non-paretic lower limb of~     individuals that suffer a stroke, while walking on a treadmill, is effective for restore gait~     symmetry of these individuals, in a subacute phase of stroke.~   "
111114|NCT02113085|"~     The purpose of the study is to implement a full-scale efficacy trial of the My Life program.~     Conducted in partnership with the Oregon DHS Foster Care Program, the impact of the~     intervention will be being evaluated with a randomized experimental longitudinal design. Two~     hundred and ten youth, ages 16.5-17.5, will be enrolled in 3 waves, and randomly assigned to~     either a comparison group that receives typical foster care services or to a treatment group~     that participates in the key elements of the model, including instruction in~     self-determination skills, support in leading their own coordinated inter-agency transition~     planning meetings, and participation in workshops with mentors. Outcomes, including youth~     self-determination, quality of life, employment, mental health, educational achievement and~     independent living, are assessed pre-intervention, at the conclusion of intervention, and at~     12 months post-intervention. The proposed study will provide important information on the~     efficacy of the model for all youth exiting the foster care system, yielding unequivocal data~     on whether enhanced self-determination mediates, at least partially, various outcome areas,~     including mental health, educational achievement, employment, independent living, and quality~     of life; evaluating the effect of special education status, gender, and race as moderating~     influences on the impact of the intervention. Foster care experiences, such as trauma and~     placement instability, will be considered as covariates; direct effects of the intervention~     on these key foster care experiences will also be explored.~   "
111115|NCT02113072|"~     The purpose of this study is to evaluate whether Probiotics promote reduction of recurrent~     wheezing in infants, stimulating the immune system to Th1 response.~   "
111116|NCT02113059|"~     The most relevant factor predicting morbidity and mortality after liver resections is the~     ability of the remnant liver to regenerate. The investigators recently demonstrated that~     serotonin and thrombospondin-1, two growth factors abundantly stored in platelets, seem to~     play a critical role in liver regeneration of patients after liver resection. The~     investigators now aim to gain more precise insight concerning the relevance of platelets and~     platelet derived growth factors in liver regeneration in humans. The investigators will focus~     on specific alpha-granula release as a key regulator of postoperative LR. Using peri- and~     intraoperative blood and tissue samples, platelet adhesion, granula release and induction of~     gene expression known to be involved in liver regeneration form experimental studies will be~     analyzed. This study should allow the investigators to verify observations from preclinical~     models and evaluate their relevance in the human setting. Furthermore, this might enable the~     investigators to identify new therapeutic targets.~   "
111117|NCT02113046|"~     The aim of this study is to investigate whether finnish binding pancreatico-jejunal~     anastomosis is feasible and prevents the risk for post operative pancreatic fistula after~     distal pancreeatectomy.~   "
111118|NCT02113033|"~     The purpose of the VANGUARD study is to demonstrate the safety of Vagal Nerve Stimulation for~     the treatment of congestive heart failure with reduced ejection fraction, and to report~     secondary measures of efficacy.~   "
111119|NCT02113020|"~     The objective of this clinical trial is to examine the clinical pharmacology properties of~     TAK-233 in healthy female subjects~   "
111120|NCT02113007|"~     This study will evaluate the safety and efficacy of high-dose rituximab combined with~     temozolomide in the treatment of patients with Primary Central Nervous System Lymphomas~     (PCNSL). This novel combination will be evaluated in PCNSL patients who are 60 years of age~     or older, or in patients 18 years or older who refuse methotrexate-based treatment.~   "
111121|NCT02112994|"~     This study will evaluate the safety and efficacy of sebelipase alfa in a broad population of~     patients with lysosomal acid lipase deficiency (LALD).~   "
111122|NCT02112981|"~     meriT-V is a Prospective,active control open lable clinical trial to compare safety &~     efficacy of BioMime Sirolimus stent Vs. Xience family of Everolimus stent by random~     assignment for treatment of coronary artery disease at multiple multinational centres.~   "
111123|NCT02112968|"~     This clinical study has been planned to evaluate the safety and effectiveness of common~     treatment algorithms using 500 Hz laser repetition rate for the correction of Ammetropia and~     Presbyopia~   "
111124|NCT02112955|"~     The aim of this study is to examine the effectiveness of a nurse-led self-efficacy enhancing~     stroke self-management program on recovery of community-dwelling stroke survivors.~   "
111125|NCT02112942|"~     A multi-part study to evaluate the safety and PK of single ascending doses of IDX21549 in~     healthy and HCV-infected subjects. The effect of food on the PK of IDX21549 will also be~     evaluated. Antiviral activity will also be assessed in HCV-infected subjects.~   "
111126|NCT02112929|"~     The investigators aim to use hyperpolarized xenon gas magnetic resonance imaging (MRI) and~     computed tomography to develop a new technique capable of objectively and quantitatively~     describing regional and structural lung abnormality. Since this is a relatively novel~     technique, the investigators first need to acquire imaging and clinical data from a group of~     participants with normal lungs. The investigators hope to generate an atlas of normality,~     which will form the foundation of future studies to compare with patients suffering from~     chronic respiratory disease. The investigators also aim to validate the new technique in~     terms of intra-subject reproducibility.~   "
111127|NCT02112916|"~     This randomized phase III trial compares how well combination chemotherapy works when given~     with or without bortezomib in treating patients with newly diagnosed T-cell acute~     lymphoblastic leukemia or stage II-IV T-cell lymphoblastic lymphoma. Bortezomib may help~     reduce the number of leukemia or lymphoma cells by blocking some of the enzymes needed for~     cell growth. It may also help chemotherapy work better by making cancer cells more sensitive~     to the drugs. It is not yet known if giving standard chemotherapy with or without bortezomib~     is more effective in treating T-cell acute lymphoblastic leukemia and T-cell lymphoblastic~     lymphoma.~   "
111128|NCT02112903|"~     The purpose of this study is to evaluate the gastro-intestinal tolerability (nausea,~     vomiting, diarrhoea, abdominal discomfort, and abdominal pain) of vortioxetine following~     single oral doses of three modified-release (MR) capsules with differently coated multiple~     particles compared to one immediate-release (IR) tablet.~   "
111129|NCT02112890|"~     This study will assess the seroprevalence of hepatitis A virus (HAV), hepatitis B virus (HBV)~     and Bordetella pertussis (B. pertussis) in adolescents and young adults in Mexico.~   "
111130|NCT02112877|"~     This is a multi-center, prospective, single arm, non-randomized study to evaluate safety and~     efficacy of the Veniti Vici™ Venous Stent System in relation to pre-defined Objective~     Performance goals. The follow-up period is 60 months.~   "
111131|NCT02112864|"~     Post thoracotomy pain syndrome still affects 50% of patients after a thoracic surgery.~     Pathogenesis is unclear but there is growing evidence that neuro inflammation may play a~     significant role. Dexamethasone is a very potent anti-inflammatory drug. The hypothesis of~     this study is that dexamethasone, given pre operatively, would help reduce the incidence of~     post thoracotomy pain syndrome 3 months after surgery, by reducing the inflammatory response,~     in patients undergoing elective thoracic surgery that includes thoracic epidural analgesia.~   "
111132|NCT02112851|"~     Randomized, placebo controlled, double blind, postprandial crossover study in male subjects.~     3 intervention arms, consisting of a control (Product A), a low dose processed whole orange~     (Product B) and a high dose processed whole orange (Product C), to determine the effect of~     the interventions on the primary endpoint of postprandial glycemia. Secondarily, plasma~     insulin concentrations will be quantified.~   "
111133|NCT02112838|"~     The purpose of this study is to determine whether fostamatinib is safe and effective in the~     treatment of IgA Nephropathy~   "
111134|NCT02112825|"~     The general objective of the study is to investigate the effect of regular aerobic exercise~     on resting and 24-hr blood pressure levels in men and women with stage 3-4 kidney disease and~     hypertension.~   "
113562|NCT02080988|"~     To assess coughing force during reflex coughing test in those with severe dysphagia and~     severe aspiration and compare them to than those with stroke patients with no signs of~     dysphagia/aspiration.~   "
111135|NCT02112812|"~     A higher prevalence of Helicobacter pylori infection rate has been demonstrated among PD~     patients compared to controls. As H. pylori infection is known to interfere with levodopa~     absorption, we embarked on this is a study to understand the effects of Helicobacter pylori~     infection eradication among a selected Malaysian population with Parkinsons disease, in~     relation to levodopa effectiveness and motor improvements.~      The study hypotheses are:~        1. H. pylori eradication improves L-dopa 'onset' time and prolongs the L-dopa 'on-time'~          duration.~        2. PD patients with H. pylori infection show clinical improvement in motor disability and~          quality of life after eradication therapy of H. pylori, assessed using UPDRS-III / PDQ39~          questionnaires.~   "
111136|NCT02112799|"~     This Phase 1 trial will assess the dose-related safety and PK profile of different doses of~     NVR 3-778, first in healthy volunteer subjects (part I) and subsequently in patients with~     chronic hepatitis B (part II). Additionally, in Part II, changes in patients' serum HBV DNA~     levels and other virologic efficacy parameters will be assessed.~   "
111137|NCT02112786|"~     Participants receiving neuromodulation treatment for overactive bladder symptoms will be~     routinely fitted with an impulse generator. However, the setting on the impulse generator~     will be set to either intermittent or continuous stimulation. Participants will complete~     voiding logs and surveys for a month. Battery life will be interrogated.After a one week~     period were the device is turned off, the impulse generator will be turned to the opposite~     setting (intermittent or continuous) and the one month period will be repeated. Again,~     voiding logs, surveys, and battery life will be collected.~      The purpose of this project is to investigate the outcomes of intermittent versus continuous~     stimulation in patients treated with sacral neuromodulation (SNM) for refractory overactive~     bladder (OAB) syndrome. In addition, the potential for an improved battery life with~     intermittent stimulation will be quantified.~   "
111138|NCT02112773|"~     The objectives of this study is to assess the characteristics and frequency of adenovirus~     conjunctivitis in a population of male and female patients from one year of age who present~     signs and symptoms of acute conjunctivitis.~   "
111139|NCT02112760|"~     1. Specific aim 1:Identify factors that influence muscle performance by use of ultrasound~          imaging.~           Hypothesis: Gender, age, and BMI affect the muscle performance of deep trunk muscles.~        2. Specific aim 2. To compare the performance of trunk deep muscles (transversus abdominis~          and multifidus) and the sensation and pain thresholds of patients with recurrent low~          back pain with asymptomatic subjects.~           Hypothesis: patients with recurrent low back pain have:~           (A) less activation of the transversus abdominis and multifidus, (B) peripheral and~          central sensitization, with decreased sensation and pain thresholds in the lumbar and~          foot areas.~        3. Specific aim 3. To determine the performance of the transversus abdominis and~          multifidus, and the sensation and pain thresholds by use of ultrasound feedback training~          in asymptomatic adults, and to compare these results with the traditional training~          protocols for trunk stabilization.~           Hypothesis: Specific stabilization exercise using ultrasound feedback training is more~          effective in activating deep trunk muscles and increasing sensation and pain thresholds~          than the traditional stabilization training protocol in asymptomatic adults.~        4. Specific aim 4. To determine the performance of the transversus abdominis and~          multifidus, and the sensation and pain thresholds by using the ultrasound feedback~          training in adults with low back pain, and to compare these results with the traditional~          training protocols for trunk stabilization.~      Hypothesis: Specific stabilization exercise using ultrasound feedback training is more~     effective in activating deep trunk muscles and increasing sensation and pain thresholds than~     the traditional stabilization training protocol in adults with low back pain.~   "
111140|NCT02112747|"~     This randomized clinical trial studies website access or genetic counseling with or without~     patient navigators on adherence to colorectal cancer screening recommendations in patients~     with newly diagnosed colorectal cancer and their first degree relatives. Websites for~     colorectal cancer prevention and genetic counseling may be effective methods to help people~     learn about cancer screening. Patient navigators may improve adherence to colorectal cancer~     screening recommendations. It is not yet known whether website access or genetic counseling~     is more effective with or without patient navigators.~   "
111141|NCT02112734|"~     There is an urgent need to prevent the onset and progression of food allergy in our~     population. Evidence demonstrates that food allergy and atopic eczema represent the earliest~     manifestations of the atopic march with 50% of infants with food allergy predicted to develop~     respiratory allergic diseases later in life. We report that Australia has the highest~     prevalence of IgE-mediated food allergy in the world, with 10% of infants having~     challenge-proven food allergy in Melbourne. There has been a 5-fold increase in hospital~     admissions for life-threatening anaphylaxis. These changes are most pronounced in children~     less than 5 years, suggesting a causal role for early life determinants. We have primary data~     to inform hypotheses for the rise in food allergy, which appears to result from potentially~     modifiable factors related to the modern lifestyle, particularly Vitamin D insufficiency~     (VDI), and have demonstrated an association between VDI and increased risk of~     challenge-proven food allergy in 12-month old infants, which supports numerous ecological~     studies showing an increased risk of food allergy the further a child resides from the~     equator (associated with decreased UV exposure and Vitamin D levels). Despite Australia's~     sunny climate, population rates of VDI have steadily increased in infants and pregnant women~     in parallel to the apparent rise in food allergic disease. This association is biologically~     plausible, as there is evidence Vitamin D is critical to the healthy development of the~     immune system in early life. We propose an intervention study to assess if infant Vitamin D~     supplementation during the first year of life significantly decreases the risk of early-onset~     food allergy. Australia is ideally placed to answer this important question since, unlike the~     USA, Canada and Europe, there are no population recommendations for routine infant~     supplementation with Vitamin D and we are one of the few developed countries that do not~     supplement the food chain supply with Vitamin D.~   "
111142|NCT02112721|"~     The aim of this study is to determine whether vitamin D supplementation in overweight/obese~     individuals with vitamin D deficiency can improve insulin secretion and/or insulin resistance~     by decreasing subclinical inflammation.~      Results of the present study may help to identify new strategies to prevent type 2 diabetes~     in high-risk groups (i.e. overweight and obese individuals, and individuals with a strong~     family history of diabetes).~      Hypothesis: That increasing plasma 25(OH)D concentrations in healthy individuals at risk for~     type 2 diabetes with low vitamin D levels through vitamin D supplementation, will improve~     insulin sensitivity and also insulin secretion by reducing the underlying sub-clinical~     chronic inflammation.~      Aims: To establish whether 16-week vitamin D supplementation given to healthy individuals~     with low vitamin D levels will:~        1. improve insulin sensitivity (in vivo and tissue) and/or insulin secretory function~        2. determine whether this relationship is mediated by a reduced chronic inflammation~   "
111143|NCT02112708|"~     Introduction: Minor psychiatric disorders are important in primary care, because of its high~     prevalence and consumption of healthcare resources generated.~      Objective: Evaluate the effectiveness of rational emotive behavioral therapy (REBT), as an~     instrument of social work intervention to enhance changes in the parameters of quality of~     life, medical consultations and drug use in patients with dysthymia.~      Design: Multicenter, prospective, not randomized clinical trial, with intervention and~     control group simultaneously in urban primary care settings and 1 year of follow up.~      Participants: Out-patients seen in two Primary Care centers diagnosed with dysthymia~     according to DSM-IV classification of American Psychiatric Association.~      Intervention: Subjects receive up to 8 biweekly individual sessions of thirty minutes of REBT~     administered by the Social Worker.~      Variables: Demographic data, educational level, coexistence, comorbidity, quality of life~     assessment, severity of depression, number of visits to the General Practitioner (GP) and~     drug consumption: sedatives / antidepressants.~      Expected Results: The expected results of the intervention, estimated from previous data,~     are:~        -  A decrease in attendance at medical visits per year~        -  An improvement in perceived quality of life, measured as values of the Quality of Life~          (QOL) questionnaire (Baker & Intagliata)~        -  An improvement in severity of depression, measured according to the Beck Depression~          Inventory.~        -  A reduction of treatment with psychotropic drugs (sedatives and antidepressants).~      Potential impact expected: The investigators hope that rational emotive theory is an~     effective intervention method for handling minor psychiatric disorders in clinical social~     work.~   "
111144|NCT02112695|"~     Abnormal opioid system have been identified in addictive behavior and activity of the opioid~     system has also shown a strong link with the nutritional balance. A significant increase in~     endorphin levels was noticed after exercise, proportional to the duration and intensity of~     this activity. One brain imaging study showed an increase in opioid activity in athletes~     after endurance training. However , a decrease in opioid tone related to receptor~     desensitization in the brain has been raised in the sport and it is possible to feel like ,~     the subject must perform physical exercise more frequently . Consequently, in order to deepen~     the hypothesis of addiction in high-level sport , the brain opioid activity should be~     assessed pre- training compared to a group of sedentary control subjects .~      Preliminary results of a previous study the investigators are conducting on anorexia nervosa~     (AN ) show abnormalities that appear to be involved in self addiction anorexia nervosa and~     the regulation of gonadal function. However, the relation of cause and effect between these~     anomalies and undernutrition remains to be determined . Given the addictive component in the~     endurance sport and the variability of the nutritional status of its practitioners ,~     evaluation of brain activity in these subjects could provide additional answers.~   "
111145|NCT02112682|"~     STUDY AIM To decrease the number of breast cancer patients receiving overtreatment of the~     axilla, in order to positively influence the axillary morbidity rate and quality of life.~      PRIMARY OBJECTIVE To determine whether omitting completion axillary treatment is not inferior~     to the current axillary treatment regimen in sentinel node positive breast cancer patients~     undergoing a mastectomy, in terms of regional recurrence rate.~      HYPOTHESIS Completion axillary treatment can be safely omitted in sentinel node positive~     breast cancer patients undergoing a mastectomy. This will lead to a decreased axillary~     morbidity rate and to an increased quality of life, with non-inferior regional control,~     distant-disease free- and overall survival rates.~   "
111146|NCT02112669|"~     This study is a prospective, multi center, randomized, controlled study of the VasQ in~     arteriovenous fistulas. The VasQ constraints and directs the geometrical parameters of the~     fistula as well as the vascular diameter and gradient in the vicinity of the AV shunt. These~     geometrical constraints direct flow and influence hemodynamics, and hence minimize turbulence~     and promote laminar flow. The device is designed to improve short term maturation and long~     term patency of the fistula. The VasQ is a permanent implant intended for use as a~     subcutaneous arteriovenous conduit support for vascular access.~   "
111147|NCT02112656|"~     The purpose of this study is to determine whether ThermoDox, a thermally sensitive liposomal~     doxorubicin, is effective in the treatment of non-resectable hepatocellular carcinoma when~     used in conjunction with standardized radiofrequency ablation (sRFA).~   "
111148|NCT02112643|"~     The purpose of this study is to determine whether sodium selenite is helpful in the treatment~     of mild thyroid eye disease in North America.~   "
111149|NCT02112630|"~     The purpose of the study is to assess the safety and efficacy of triple therapy with~     pegylated interferon (P-IFN), ribavirin and boceprevir in patients with genotype 1 chronic~     Hepatitis C Virus (HCV) infection and end stage renal disease (ESRD) on hemodialysis (HD).~   "
111150|NCT02112617|"~     This research study is evaluating a therapy called proton beam radiation therapy (PBRT) as a~     possible treatment for neuroblastoma.~      Neuroblastoma most commonly occurs in and around the adrenal glands, which are located at the~     top of the kidneys. However, it can also occur in other areas where groups of nerve cells~     exist, such as other areas of the abdomen, neck and near the spine.~      Conventional radiation therapy with photons is used as standard treatment for many patients~     with neuroblastic tumors. In this research study, the investigators are looking at another~     type of radiation called proton radiation which is known to spare surrounding tissues and~     organs from unnecessary radiation. Proton radiation delivers radiation to the area requiring~     radiation. This may reduce side effects that patients would normally experience with standard~     radiation therapy or other means of delivering proton radiation therapy.~      In this research study, the investigators are evaluating the effectiveness of using proton~     radiation delivered to reduce side effects associated with radiation treatment. The~     investigators will also be assessing the late side effects experienced by participants in~     each treatment group.~   "
111162|NCT02112461|"~     Improving end-of-life care and the suffering caused by poorly controlled symptoms is an~     important public health concern. The development of an automated telephone symptom monitoring~     and support system that assists caregivers in providing end-of-life care and communicating~     information to the patient's hospice nurse has the potential to enhance the management of~     common end of life symptoms, thus reducing the suffering of patients at end of life as well~     as the suffering of their family caregivers. This study has developed such a system and is~     testing the effectiveness of this system.~   "
111151|NCT02112604|"~     This is part 2 of the #NCT01618240 under the same IRB protocol #2010P001919. The primary~     objective of this study is to examine factors that are related to sleep-disordered breathing~     and upper airway patency in critically ill patients who have been recently mechanically~     ventilated. Our primary hypothesize is that sedatives and neuromuscular blocking agents given~     in the ICU prior to extubation and during the first night following extubation are associated~     with sleep-disordered breathing. The secondary hypotheses are that duration of mechanical~     ventilation, BMI, and muscle strength are associated with sleep-disordered breathing during~     the night after extubation.~      The secondary objective is to evaluate if sleep-disordered breathing in the ICU can be~     predicted by standard pulmonary function testing in the ICU.~   "
111152|NCT02112591|"~     Introduction:~      Minimally invasive procedures TOT (tension-free suburethral tape using transobturator~     approach)have been the standard for correction of SUI. However, around 28% of these patients~     exhibit alteration of urinary flow. Recently, in 40 patients who underwent open surgery, an~     abdominal fascia tape was placed in a subtrigonal position with a success rate of 87.5%~     without obstruction. Our intention is to make the most of the idea of subtrigonal position in~     minimally invasive procedures with transobturator polypropylene vaginal tape (S-TOT).~      Object of the Study: To evaluate the efficacy and security of S-TOT compared with TOT.~      Materials and Methods:~      Study Population:~      Patients of the Mexican Institute of Social Security (IMSS) with an SUI diagnosis.~     Eligibility requirements: history of at least 3 months with symptoms of isolated SUI or~     symptoms of SUI associated with urge urinary incontinence (mixed UI). The size of the sample~     was estimated 34 subjects are required per group.~      Study Design:~      It is a parallel group randomized clinical trial. Success (efficacy) will be defined as when~     the SUI has been corrected with negative pad test and normal urinary flow.~      The results (efficacy) will be compared between the two groups using chi2 (group a/b versus~     success/lack of success). In all cases, p <0.05 will be considered significant.~      The data will be obtained with clinical evaluation, laboratory and radiological/imaging tests~     and the respective questionnaires during the visits before surgery, and at 2 and 6 weeks, and~     6, 12, and 24 months after surgery.~   "
111153|NCT02112578|"~     -  Evaluation of the non inferiority of Meclin (meclizine) versus Dramin (Dimenhydrinate)~          to treat the symptoms of acute vertigo from peripheral origin after up to 4 weeks of~          treatment;~        -  Evaluation of impact on quality of life in vertigo;~        -  Compare the intensity of daytime sleepiness in the two treatment groups;~        -  Compare the efficacy of drugs in relieving each of the 10 symptoms that make up the VS;~        -  Compare the duration of treatment in both treatment groups;~        -  Compare Adehence;~        -  Compare the level of satisfaction from each group from the investigators and the~          subjects;~        -  Adverse events;~   "
111154|NCT02112565|"~     This phase I trial studies the side effects and best dose of RNR Inhibitor City of Hope 29~     (COH29) in treating patients with solid tumors that are refractory to standard therapy or for~     which no standard therapy exists. COH29 may inhibit an enzyme called ribonucleotide reductase~     and may interfere with the ability of tumor cells to grow.~   "
111155|NCT02112552|"~     This pilot, phase II trial studies the side effects and how well paclitaxel given into the~     vein and carboplatin given directly into the abdominal cavity (intraperitoneally) followed by~     radiation therapy work in treating patients with stage IIIC-IV serous uterine cancer. Drugs~     used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the~     growth of tumor cells, either by killing the cells, stopping them from dividing, or stopping~     them from spreading. Giving the drugs in different ways may kill more tumor cells. Radiation~     therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy followed by~     radiation therapy may be an effective treatment for uterine cancer.~   "
111156|NCT02112539|"~     The study is to characterize the AggreGuide ADP Assay's performance.~   "
111157|NCT02112526|"~     To characterize the safety profile of ACP-196 in subjects with relapsed or refractory de Novo~     Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma (DLBCL).~   "
111158|NCT02112513|"~     The objective of this project is to evaluate clinical significance of measuring maternal~     blood estriol levels, after the administration of antenatal corticosteroids to enhance lung~     maturity. The investigators will test for associations of the change in maternal estriol with~     the development of respiratory distress syndrome. The investigators are also interested in~     determining whether salivary estriol is a valid surrogate to estriol blood assays. In~     addition the investigators will correlate these changes to pharmacokinetic (PK),~     pharmacodynamics (PD), and pharmacogenetic measures of betamethasone administration and fetal~     respiratory outcome~   "
111159|NCT02112500|"~     Although the advent of advanced medical support for respiratory failure, the mortality rate~     of acute severe respiratory failure is still high and the life quality is frequently~     compromised from pulmonary fibrosis.~      The investigators hypothesize that the treatment using mesenchymal stem cell can be~     beneficial in patients with respiratory failure. The present study is a pilot study~     evaluating the efficacy and safety of mesenchymal stem cell treatment in patients with~     respiratory failure.~   "
111160|NCT02112487|"~     Prospective, multi-center, open-label, single-arm, Phase 3b extension study of macitentan in~     patients with PAH.~      To assess the long-term safety of macitentan in patients with pulmonary arterial hypertension~     (PAH) beyond treatment in the AC-055-310 study.~   "
111161|NCT02112474|"~     Electrical stimulation of the spinal cord (Spinal Cord Stimulation or SCS) for pain relief~     has been used for decades. It is used most commonly in patients with chronic neuropathic leg~     pain, after spinal surgery. Conventional neurostimulation is applied in frequencies of 30 to~     60 Hertz (Hz) and perceptible paraesthesias are felt. Stimulation using higher frequencies~     with sub perception paraesthesias has recently challenged the conventional form of~     neurostimulation.The high frequency stimulation appears to show better pain relief for both~     back and limb pain in comparison to low frequency SCS, and may also to be effective in some~     subjects who did not respond to low frequency SCS.~   "
111163|NCT02112448|"~     The investigators hypothesize that intermittent bolus doses of morphine and midazolam can~     provide the same pain control after pediatric cardiothoracic surgery as bolus doses plus~     infusions while using smaller total doses of both medications.~      The investigators will randomize patients to receive either morphine/midazolam as needed~     intermittently or morphine/midazolam drips plus intermittent doses to be received as needed.~     Pain scores will be recorded and total medications given will be recorded.~   "
111164|NCT02112435|"~     Sleep apnea is a common disorder that occurs in 3-10 % of the adult population. This disorder~     disrupts the architecture and quality of sleep. Continuous positive airway pressure (CPAP)~     therapy is the standard treatment, but in some cases, it can not be used (patient refusal or~     intolerance). In these cases, treatment with mandibular advancement devices can bring an~     improvement in symptoms. Therefore, this study aims to compare the effectiveness of~     titratable versus active mandibular advancement splints in standard care environment. This~     will be based on the global response, which includes the apnea-hypopnea index and compliance~     in severe apnea patients who refused or where intolerant to CPAP. Following their severe~     apnea diagnosis and the assessment on the feasibility of placing a mandibular advancement~     device, follow-up visits will be scheduled after 3 months of treatment involving clinical~     monitoring by a physician and a dentist.~   "
111165|NCT02112422|"~     The purpose of our study was to evaluate the hypothesis that single dose dexamethasone given~     sixty minutes preoperatively reduces visual analog scale (VAS) pain scores and improves~     quality of recovery in patients undergoing elective cesarean section as compared to the same~     dose given immediately prior to skin incision.~   "
111166|NCT02112409|"~     Surgical correction of scoliosis with instrumentation carries significant blood loss and~     needs for blood transfusion with its inherent risk and cost. In recent years, there is an~     increased interest in utilizing autologous blood as part of perioperative blood conservation~     strategy.~      The foremost mechanical methods of perioperative conservation of red blood cells including~     intraoperative cell salvage (ICS) and acute normovolemic hemodilution (ANH). They should be~     considered in all cases where significant blood loss (>1000 ml) or >20% estimated blood~     volume is expected, in patients with multiple antibodies or rare blood types and those who~     refuse allogenic blood products.~      Literature search has revealed that both cell salvage method and ANH utilized in elective~     surgeries are capable of minimizing allogenic blood transfusion respectively. Surgeries which~     are of significant relevance are aortic surgery, cardiac surgery and arthroplasty orthopaedic~     surgery. Combining the above two techniques such as in ATIS trial 2002 also shows that it is~     safe and significantly reduced allogenic blood requirements in aortic surgery. However till~     date, there is still lack of strong evidence that autologous blood transfusion technique is~     beneficial for scoliosis surgery in reducing allogenic blood transfusion.~      Hypothesis:~      The investigators hypothesize that the addition of ANH to ICS would confer additional benefit~     than using cell saver alone. By combining cell saver with hemodilution technique, the~     difference between pre-operative and post-operative Hemoglobin level will be smaller than~     using cell saver technique alone, hence minimizing the variation in perioperative Hemoglobin~     level - a predictor of allogenic blood transfusion.~   "
111167|NCT02112396|"~     The present study examines the efficacy of the Community Reinforcement and Family Training~     (CRAFT) for Concerned Significant Others (CSOs) of individuals with alcohol use disorders~     (AUDs) using a randomized waiting list (WL) control group. It is hypothesized that after the~     Intervention group has received CRAFT and prior to the WL- group having received CRAFT,~     treatment utilization of individuals with AUDs are substantially elevated in the Intervention~     group.~   "
111168|NCT02112383|"~     Procrastination is defined as a voluntarily delay of an intended course of action despite~     expecting to be worse-off for the delay, and is considered a persistent behavior pattern that~     can result in major psychological suffering. About one-fifth of the adult population and half~     of the student population are presumed having substantial difficulties due to recurrent~     procrastination in their everyday life. However, chronic and severe procrastinators seldom~     receive adequate care due to preconceptions and the lack of understanding regarding~     procrastination and the treatment interventions that are assumed beneficial. Cognitive~     behavior therapy is often deemed treatment of choice, although the evidence supporting its~     use is scarce, and only one randomized controlled trial has been performed. The primary aim~     of the current study is therefore to test the efficacy of cognitive behavior therapy~     delivered as either a group intervention or via the Internet. Participants will consist of~     students recruited through the Student Health Centre at Karolinska Institutet. A randomized~     controlled trial with a sample size of 100 participants divided into two conditions will be~     employed; a ten week Internet-based cognitive behavior therapy intervention, and an eight~     week group intervention based on cognitive behavior therapy. The current study is believed to~     result in two important findings. First, different interventions inherent in cognitive~     behavior therapy are assumed to be helpful for people suffering from problems caused by~     procrastination. Second, both a group intervention and an Internet-based cognitive behavior~     therapy intervention are presumed suitable for administering treatment for procrastination,~     which is considered highly important as the availability of adequate care is limited,~     particularly among students. The current study will increase the knowledge regarding the~     efficacy of different treatments of procrastination, as well as enhance the overall~     comprehension of the difficulties related to dilatory behavior.~   "
111169|NCT02112370|"~     To assess the pain relief and the hemodynamic stability of ropivacaine with epinephrine in~     BABA endoscopic and robotic thyroidectomy.~   "
111170|NCT02112357|"~     This study will assess the feasibility of sequencing locally advanced/metastatic~     gastrointestinal cancers in real-time to enable future treatment stratification by molecular~     characteristics. Targeted next generation sequencing of a panel of genes will be performed on~     tumour specimens and results will be discussed at a Sequencing Tumour Board to establish if a~     patient is potentially suitable for a targeted therapy.~   "
111171|NCT02112344|"~     Squamous cell carcinoma of unknown primary (SCCUP) site metastatic to cervical lymph nodes at~     presentation is a relatively rare entity forming about 2% of all head and neck carcinomas.~      Typically patients are treated with ipsilateral modified radical neck dissection (MRND) and~     post-operative radiotherapy (PORT) or chemoradiotherapy.~      There is a lack of consensus on the radiotherapy target volumes that should be treated after~     neck dissection. The most common radiotherapy techniques are either unilateral cervical lymph~     node irradiation to achieve local control in the ipsilateral neck or TMI of the head and neck~     region with the aim of eradicating the primary and the microscopic neck disease.~      Treatment of the ipsilateral hemi-neck alone is of low toxicity and may achieve local control~     in the cervical nodes. Potential occult primary sites in the head and neck mucosa, and any~     sub-clinical metastatic disease in the contralateral side of the neck are left untreated. If~     a primary tumour subsequently becomes apparent the previous radiotherapy may make further~     radiotherapy difficult to deliver.~      Some groups recommend bilateral neck and total mucosal irradiation in this setting claiming~     improved local control. With conventional radiotherapy technique this is at the price of~     significant acute toxicity and chronic morbidity, mainly xerostomia with its associated~     complications and effects on quality of life (QOL).~      Intensity modulated radiotherapy (IMRT) has been shown to reduce the dose to salivary gland~     tissue and consequently may reduce the incidence of xerostomia and improve quality of life~     (QOL) in head and neck cancer patients.~      An analysis of parotid-sparing IMRT at the University of Michigan established a mean dose~     threshold for both stimulated (26 Gy), and unstimulated (24 Gy) saliva flow rates. For the~     same end-point (less than 25% of flow at baseline one year post radiation) Roesink et al~     established a TD50 of 39 Gy.~      The investigators performed a planning study to assess the feasibility of IMRT to spare the~     parotid gland while delivering bilateral neck and TMI. The mean dose to the contralateral~     parotid gland using IMRT was below the threshold of 24 Gy for unstimulated salivary flow,~     predicting a fairly low risk of radiation induced xerostomia. The mean dose to the~     ipsilateral parotid gland was 32 Gy which was below the TD50 dose based on the Roesink data.~      This study assesses the safety and tolerability of delivering IMRT in clinical practice to~     treat patients with SCCUP of the head and neck region, who require bilateral neck and~     pan-mucosal irradiation.~   "
112527|NCT02094560|"~     To assess the anti-tumor activity of CAP7.1 based on the observed objective response rate and~     rate of disease stabilization, as defined by the below primary and secondary endpoints, in~     patients with NSCLC, SCLC or biliary cancer who have progressed despite one or more previous~     chemotherapy line.~   "
111172|NCT02112331|"~     The optimization of newborns nutrition is a challenge especially for preterm newborns for~     whom nutrition plays a crucial part in cerebral and global development. Human milk is~     considered as the best food for newborns. Several short and long-term beneficial health~     effects were attributed to breastfeeding and have induced the increase of human milk in~     preterm newborns nutrition.~      Whereas the chemical composition of infant formula has been optimized to mimic human milk,~     there is still a major difference between the structure of human milk and commercial infant~     formulas. It is well known in adult nutrition that the structure of emulsions influences~     their susceptibility to hydrolysis, such results have been obtained either on in vitro or in~     vivo studies.~      Human milk is a natural emulsion (oil in water). Lipids droplets are dispersed under the form~     of entities called milk fat globules (average diameter 4 µm, span 0.1-20 μm). The globules~     are stabilized by a trilayered membrane composed mainly of polar lipids (phospholipids,~     sphingolipids and gangliosides), of proteins, neutral lipids and other minor compounds.~      The physical treatments apply to human milk or more generally to bovine milk to pasteurize or~     stabilize the milk modify the structure of the natural emulsion. Heat treatment for instance~     induces whey proteins denaturation and the adsorption of protein aggregates on the surface of~     the milk fat globules. Heat treatment also leads to the denaturation of bile salt stimulated~     lipase. These effects limit intragastric lipolysis in preterm newborns.~      Conversely, reduction of milk globules size, by homogenisation of milk, increases the~     specific surface available for lipase adsorption and limits the lost of fat during enteral~     administration of milk. Such treatment could thus enhance gastric lipolysis and improve fat~     absorption of preterm newborns.~      The objective of this trial is to evaluate the effects of physical treatments (pasteurization~     and homogenisation by ultrasonication) applied to human milk on gastric lipolysis and milk~     destructuration. This trial is conducted, in vivo, on preterm newborns.~   "
111173|NCT02112318|"~     The study is aimed at testing the hypothesis whether atrial fibrillary rate (AFR), as a~     measure of atrial electrical remodeling assessed from surface ECG, is predictive of sinus~     rhythm maintenance after electrical cardioversion.~      Earlier studies performed in a retrospective fashion suggested that high AFR exceeding~     350-360 fibrillations per minute is an independent predictor of AF relapse after~     cardioversion, particularly in patients with duration of AF episode not exceeding 30 days,~     however this hypothesis has not been tested in a prospective study.~      CASAF is an observational study that will enroll patients with short duration (< 30 days) AF~     admitted for electrical cardioversion. Admission ECG will be extracted in a digital format~     and processed off-line for estimation of AFR. AF relapse will be assessed during 6-weeks long~     follow-up period during which ECG control will be scheduled at week 1 and 6.~   "
111174|NCT02112305|"~     The purpose of this study is to determine whether nebulized magnesium sulphate is effective~     in the treatment of acute severe asthma when comparison with intravenous magnesium sulphate~   "
111175|NCT02112292|"~     The endocannabinoid (eCB) system, a neurochemical signalling system consisting of~     CB-receptors and their endogenous ligands, has been found to be involved in food intake of~     sweet and palatable foods. Activation of the eCB system increases food intake and vice versa.~     The mechanism behind this effect is still unknown and the current study aims at clarifying~     why sweet food intake increases. It is hypothesized that sweet taste intensity increases and~     that sweet taste is experienced as more pleasant.~   "
111176|NCT02112279|"~     Clostridium-difficile (C-difficile) is a gram positive anaerobic spore-forming bacterium that~     can lead to severe diarrhea and pseudomembranous colitis. According to Schroeder (2005),~     there are approximately 3 million cases annually with a mortality rate of 1-2.5 %. It is most~     often associated with overuse of antibiotics. According to Bartlett & Gerding (2008), 15-25%~     of anti-microbial-associated diarrhea is caused by C-difficile.~      The purpose of this study is to determine if donor fecal microbiota transplant via~     colonoscopy reduces refractory C-difficile infection better than current routine methods such~     as continued antibiotic treatment. Specifically, we hypothesize that fecal microbiota~     transplant via colonoscopy will result in a higher C-difficile cure rate in affected patients~     versus care as usual in a retrospective cohort.~   "
111177|NCT02112266|"~     One Aim of the current study is to better understand why some patients suffering from~     depression do not seek professional help by doctors but in the internet.~      Furthermore patients with depression will receive Online Therapy for depression. Aim of this~     part of the study is to investigate whether quality of life changes accordingly to~     improvement of symptoms after online therapy.~   "
111178|NCT02112253|"~     The motor tics associated with Tourette's syndrome may be reduced with deep brain stimulation~     of the anterior globus pallidus. The best area within this brain region and the best~     stimulation device settings are currently unknown. This is a study in which deep versus~     superficial electrode contact positions and two different amplitudes of stimulation are~     compared under scientific conditions. The hypothesis is that one contact position/stimulation~     amplitude combination will provide a better outcome than the others. Each study participant~     receives each of four different anatomical position/stimulation amplitude setting~     combinations over a 12 month period in randomized order followed by a 6-month period of~     trial-and-error device programming to optimize control of motor tics. Motor tics, potential~     side effects, daily functioning and quality of life are assessed at the end of each trial~     stimulation period. At the end of the study, the study participant continues to have~     long-term deep brain stimulation treatment with whatever settings provide the most relief.~   "
111179|NCT02112240|"~     The purpose of this study is to see if investigators can develop a technique to identify~     sentinel lymph nodes in the rectum for rectal cancer patients with the use of a radiotracer~     (Tc-sulfur colloid), a dye (Spot), and imaging, both pre- and intraoperatively. Eligible~     patients are those with stage I-III rectal cancer undergoing standard low anterior resection~     or abdominoperineal resection.~      Investigators hypothesize that use of a unique intraoperative lymphatic mapping technique~     using a mobile gamma camera will identify the sentinel lymph node in patients with rectal~     cancer with greater than 80% sensitivity.~      Subjects will receive injections of the tracer and dye prior to surgery, have preoperative~     SPECT/CT imaging to be used as a guide to the rectal lymphatic system and then proceed to~     their scheduled surgery. During surgery, images of the rectum will be taken with a unique~     mobile gamma camera prior to removal and upon resection.~      If surgeons are able to identify the sentinel lymph nodes surrounding the rectal tumor, the~     hope is to combine this technique with a less invasive surgery called transanal endoscopic~     microsurgery (TEM) for early stage rectal cancer patients.~   "
111258|NCT02111200|"~     The investigators will study and compare how effectively sodium phenylbutyrate, sodium~     benzoate, and a combination of the two, help excrete nitrogen in healthy volunteers. Subject~     participation will require three, separate, four-day study periods at least one week apart.~     During one study period (also called a treatment arm), subjects will take sodium~     phenylbutyrate; during another they will take sodium benzoate; during another they will take~     a combination of the two medications.~      We expect to find that phenylbutyrate is more effective at removing nitrogen than benzoate or~     a combination of the two.~   "
111180|NCT02112227|"~     Heart failure (HF) is the most common cause of hospitalization in older adults. The month~     after hospital discharge represents a vulnerable period, when patients are at increased risk~     of death and readmission to hospital. Research has shown that certain discharge-planning~     services can reduce death and readmissions, but these have not been widely implemented. In~     this study, we will group evidence-informed discharge-planning services into~     'Patient-centered Care Transitions in HF' (PACT-HF), a model of care that will prepare~     patients for their transition from hospital to home. Through PACT-HF, patients will benefit~     from a comprehensive assessment of their health care needs, learn to recognize and manage~     symptoms of HF, and receive the information and follow-up care needed to optimize their~     health. We will introduce PACT-HF to 10 Ontario hospitals over a number of time periods using~     a stepped wedge cluster trial design. We will compare the outcomes (hierarchically ordered)~     of patients in hospitals with PACT-HF to those in hospitals without PACT-HF. We anticipate~     that patients hospitalized at the sites with PACT-HF will have fewer readmissions, emergency~     visits, and deaths after discharge; report a better quality of life; and feel more prepared~     for discharge. We also anticipate that overall, PACT-HF will reduce health system costs.~   "
111181|NCT02112214|"~     The aim of this study is to define the role of H. pylori eradication in the prevention of~     gastric cancer and its precursors in the context of a population-based endoscopic screening~     program.~   "
111182|NCT02112201|"~     Girls in the juvenile justice system who have high rates of delinquency, drug abuse, and~     trauma are particularly at risk for engaging in risky sexual behavior and for contracting~     HIV/AIDS or other sexually transmitted infections (STIs). No effective prevention programs~     for girls who have this combination of behaviors is known to exist at this time. Researchers~     are developing, assessing, and implementing a family-centered prevention program to decrease~     girls' participation in the risky behaviors associated with the spread of HIV and STIs. The~     program also includes a group-based training and support program for parents.~   "
111183|NCT02112188|"~     The purpose of the study is to modify a type of counseling called Individual Meaning~     Centered Psychotherapy to meet the needs of Chinese cancer patients. Many cancer patients~     use counseling or other resources to help cope with the emotional burden of their illnesses.~     Counseling often helps them cope with cancer by giving them a place to express their~     feelings. Meaning-Centered counseling aims to teach cancer patients how to maintain or even~     increase a sense of meaning and purpose in their lives, despite cancer.~   "
111184|NCT02112175|"~     The purpose of this study is to compare the safety and efficacy of Lenalidomide versus~     Placebo maintenance following melphalan, prednisone and velcade induction therapy in newly~     diagnosed multiple myeloma.~      After the study is unblinded, subjects in treatment Arm A (Len 10 mg) will remain on study~     therapy at the Investigator's discretion and subjects in treatment Arm B (placebo), will be~     discontinued from study treatment. Subjects who discontinued from study treatment for any~     reason will enter the LTFU Phase.~   "
111185|NCT02112162|"~     This pilot clinical trial studies gene expression analysis and fludeoxyglucose F 18 (FDG)~     positron emission tomography (PET)/magnetic resonance imaging (MRI) in evaluating treatment~     response in patients with rectal cancer that has spread to nearby tissue or lymph nodes~     undergoing chemotherapy and radiation therapy before surgery. Studying samples of tissue in~     the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid~     (DNA) and may also help doctors predict a patient's response to treatment before surgery.~     PET-MRI is a procedure that combines the pictures from a PET scan and an MRI scan. The~     combined scans give more detailed pictures of areas inside the body than either scan gives by~     itself. PET-MRI may help determine how well people respond to pre-surgery chemotherapy and~     radiation therapy and help the surgeon make the best plan for removal of the tumor.~   "
111186|NCT02112149|"~     The proposed study is a randomized trial evaluating the impact of the 12-week LIVESTRONG~     exercise program vs. waitlist control on cancer-related outcomes in 200 cancer survivors.~   "
111187|NCT02112136|"~     The aim of this study is to identify families with ADPKD , characterize the phenotype and~     screen for mutations in known genes (PKD1 and PKD2, and then HNF1b and UMOD in PKD1 PKD2~     negative carriers).~      Genome wide analysis will be performed in families without mutations identified.~   "
111188|NCT02112123|"~     The purpose of this study is to investigate the pharmacokinetic properties of icariin, an~     active ingredient in the over-the-counter supplement, Horny Goat Weed.~   "
111189|NCT02112110|"~     The purpose of this study is to determine the absolute bioavailability of 150 mg oral dose of~     BMS-791325 relative to 100 µg IV infusion of [13C]-BMS-791325.~   "
111190|NCT02112097|"~     AUTOMATIC SUBDERMAL INJECTOR SYSTEM (ASIS) Corporation has developed and patented the only~     automatic injection system for delivery of injectable products to the optimum spot, just~     outside of the fascia, which exists subdermally (between the skin and muscle) or interfascial~     (between the deeper muscles). ASIS device creates that bloodless space, enhancing Enbrel's~     efficacy and preventing unnecessary distant spread and adverse reactions. This space remains~     bloodless as long as the skin is lifted up or filled with an injectable product. Although~     ASIS device was initially designed to best administer BOTOX for such muscular conditions as~     Upper limb Spasticity, Cervical Dystonia, Chronic Migraine, Strabismus, Blepharospasm, and~     Primary Axillary Hyperhidrosis, the technology will also benefit other injectable products,~     including: GAMMAGARD for Primary Immunodeficiency (PI) and Insulin for Diabetics, etc.~   "
111191|NCT02112084|"~     Individuals providing end-of-life caregiving to partners with terminal cancer often begin the~     bereavement process before the patient dies and with additional sources of stress. We know~     that grief for these partners can be long-term and impact virtually every aspect of their~     lives. This project will test the effectiveness of a new promising intervention that uses a~     dual process model (DPM) which focuses both on loss orientation (emotional loss and grief~     (referred to as LO)) and restoration orientation (learning new tasks of living that may have~     been the primary responsibility of the spouse who has died (referred to as RO tasks)).~   "
111192|NCT02112071|"~     The general objective is to investigate the effect of a 12 week walking exercise program on~     vascular endothelial function, arterial stiffness/compliance, and vascular health biomarkers~     in men and women with pre-dialysis type 2 diabetic kidney disease (DKD).~   "
112528|NCT02094547|"~     To compare the neurocognitive and immunological development in infants fed a new infant~     formula with functional specific nutrients to infants consuming a standard infant formula.~   "
111193|NCT02112058|"~     The Supporting Healthy Marriage (SHM) evaluation was launched in 2003 to test the~     effectiveness of a skills-based relationship education program designed to help low- and~     modest-income married couples strengthen their relationships and to support more stable and~     more nurturing home environments and more positive outcomes for parents and their children.~     The evaluation was led by MDRC with Abt Associates and other partners, and it was sponsored~     by the Administration for Children and Families, in the U.S. Department of Health and Human~     Services.~      SHM was a voluntary, year long, marriage education program for lower-income, married couples~     who had children or were expecting a child. The program provided group workshops based on~     structured curricula; supplemental activities to build on workshop themes; and family support~     services to address participation barriers, connect families with other services, and~     reinforce curricular themes. The study's random assignment design compared outcomes for~     families who were offered SHM's services with outcomes for a similar group of families who~     were not but could access other services in the community.~   "
111194|NCT02112045|"~     This randomized phase II trial compares how well adding XMO2 Filgrastim (Granix) to melphalan~     before a stem cell transplant works in treating patients with multiple myeloma. Chemotherapy~     drugs, such as melphalan, are given to prepare the bone marrow for the stem cell transplant.~     Giving colony-stimulating factors, such as XMO2 Filgrastim (Granix), may help multiple~     myeloma cells move from the patient's bone marrow to the blood where they may be more~     sensitive to treatment with melphalan. It is not yet known whether adding XMO2 Filgrastim~     (Granix) to melphalan before a stem cell transplant will work better than melphalan alone in~     treating multiple myeloma~   "
111195|NCT02112032|"~     This study is to test how safe it is to give the combination of PEG IFN-α2b (SYLATRON) and~     MK-3475, an investigational drug, to patients with advanced melanoma. Its effectiveness~     against melanoma will also be evaluated.~   "
111196|NCT02112019|"~     Sjögren's syndrome (SS) is an autoimmune inflammatory disorder of the exocrine glands. It~     particularly affects the lacrimal and salivary glands. Severe dry mouth and eyes are~     frequently reported as presenting symptoms. These symptoms are in many cases accompanied by~     nonspecific symptoms, such as malaise and fatigue. In addition, extraglandular~     manifestations, like purpura, polyneuropathy, and arthritis, can be present. SS affects~     mainly women with a female/male ratio of 9:1 and can occur at all ages. Due to the~     irreversible damage to the saliva producing cells, the quantity and quality of saliva~     reduces. The progressive nature of the syndrome results in a further reduction of salivary~     flow. Due to hyposalivation the patients suffer from progressive dental decay, dental~     erosion, severe dry mouth complaints (i.e. eating and swallowing problems, lack of taste),~     inflammation of the oral mucosa and lack of retention of removable dentures. Overall, this~     can be qualified as a reduction in the quality of life. Until now no effective (palliative)~     therapy to relieve dry mouth complaints is available. A recent case series study suggests~     that an endoscopic technique (sialoendoscopy) is able to alleviate the symptoms of patients~     suffering from SS. In this technique the ducts of the salivary glands are rinsed with saline~     and cortisone and possible strictures are dilated. It is hypothesised that performing a~     sialoendoscopic treatment will raise or restore (un)stimulated salivary flow levels and~     improve the reported mouthfeel score.~   "
111197|NCT02112006|"~     The purpose of this study is to compare two different injection sites for local anesthesia in~     patients having hand surgery. The hypothesis is that subjects receiving injections around the~     three nerves of the forearm will provide faster pain control and greater patient satisfaction~     than patients having one injection closer to the shoulder.~   "
111198|NCT02111993|"~     The objective of this study is to evaluate myocardial injury, if any, as quantified by~     cardiac markers (Troponin-T) in defibrillation threshold (DFT) testing during implantation of~     implantable cardioverter defibrillators (ICDs) using the upper limit of vulnerability (ULV)~     method vs. standard defibrillation threshold method.~   "
111199|NCT02111980|"~     If a surgical sponge is mistakenly left inside a patient's body after a surgical procedure,~     it can cause a serious infection. To prevent this from happening, a new device has been~     developed that uses radiofrequency (RF) signals to detect the presence of surgical sponges~     inside the body. The device is now being used routinely to make sure that no sponges are left~     inside a patient at the end of an operation. However, the RF device has not been implemented~     in procedures for patients with cardiac implantable electronic devices (CIEDs). While the~     device is FDA approved for use, there is a theoretical concern that the radiofrequency~     signals used to detect the sponges will change the settings on the pacemaker or the~     defibrillator. Changing the settings on a pacemaker might make it pace the heart too quickly~     or too slowly, while changing the settings on a defibrillator might cause unnecessary shocks~     or prevent it from shocking the heart if the patient were to have cardiac arrest.~      The purpose of this study is to test whether the radiofrequency device used to detect sponges~     can cause a clinically significant change to the settings on pacemakers and defibrillators.~     To minimize potential risk, the device will be tested only on patients who are having the~     pacemaker or defibrillator removed or replaced as part of their regular medical care, either~     because it is infected or because the battery has worn out. Before the pacemaker or~     defibrillator is removed, the settings will be carefully and completely recorded and the~     radiofrequency device will be used to scan the body for sponges as it would be done during~     normal operation.~      After the pacemaker or defibrillator is taken out, the settings will again be recorded and~     compared to the settings before the scan. In a standard device removal procedure, no~     clinically significant change in CIED settings would be expected. If a new pacemaker or~     defibrillator is implanted in the patient, it will not be exposed to the detection device at~     all. We will also test whether the RF device has any effect on temporary pacemakers that~     patients may receive after open heart surgery. We plan to perform testing in a total of 50~     patients, 40 with permanent pacemakers or defibrillators and 10 with temporary pacemakers.~   "
111200|NCT02111967|"~     In this study we compare the vitamin B12 status by measuring serum vitamin B12 and~     holotranscobalamin in type 2 diabetic patients with and without metformin treatment.~     Afterwars we investigate which biomarker could be adequate to reflect B12 status in~     metformin-treated patients.~      With the help of a questionnaire we assess clinical, nutritional and demographic factors~     which are associated with vitamin B12 deficiency.~   "
111201|NCT02111954|"~     Prostate cancer patients for whom a F-18-FCH PET/CT is indicated. Ga-68-NODAGA-MJ9 is a new~     PET/CT radiotracer aiming at giving complementary information : more precise images and early~     localisation of recurrence to standard imaging~   "
111202|NCT02111941|"~     This pilot clinical trial studies the safety and immunogenicity of vaccine therapy in~     treating patients with stage IIIC-IV ovarian epithelial, fallopian tube, or primary~     peritoneal cavity cancer following surgery and chemotherapy. Vaccines made from a person's~     peptide treated white blood cells may help the body build an effective immune response to~     kill tumor cells.~   "
111203|NCT02111928|"~     This observational pilot-study is intended to collect outcome data from a cohort of 30~     patients suffering from hyper-evaporative dry eye disease who are treated with the medical~     device NovaTears® eye drops for a duration of 5 to 7 weeks.~   "
127149|NCT01903148|"~     The purpose of this study is to evaluate the impact of the last recommendations of the~     European Anemia Working Group ERBP in the anemia management in the achievement of the~     therapeutic goal of Hb 11-12 g/dL.~   "
111204|NCT02111915|"~     The rates of perinatal depression in South Asian women are reported to be amongst the highest~     in the world, ranging from 18%-30% in urban areas and 28%-36% in rural areas. In addition to~     its profound impact on women's health, disability and functioning, perinatal depression is~     associated with poor child health outcomes such as pre-term birth, infant under-nutrition and~     stunting. There is robust evidence that perinatal depression can be effectively managed with~     psychological treatments delivered by non-specialist health care workers. Our previous~     research conducted in Pakistan led to the development of the Thinking Healthy Program (THP).~     THP is a psychological treatment delivered by community health workers (CHWs) which more than~     halved the rate of perinatal depression among mothers and led to significant improvements in~     child health outcomes. To enhance access to such evidence-based psychological treatments,~     there is a need to examine the potential role of other human resources such as lay persons in~     delivering psychological treatments such as THP in poor resource settings.~   "
111205|NCT02111902|"~     The availability of data on plasma 25-Hydroxyvitamin D (25(OH)D) concentrations in the last~     two rounds of the National Health and Nutrition Examination Survey (NHANES) has generated a~     high level of interest in the consequences of 25(OH)D deficiency and in particular its~     potential impact on black Americans. Fundamental new questions about the biology of vitamin D~     have now come to the fore. Are low 25(OH)D-intact parathyroid hormone (iPTH) levels a~     physiologic abnormality in African Americans or does the 25(OH)D-iPTH system have~     sufficient plasticity to adapt to low sunlight exposure? Could the low 25(OH)D levels which~     result from the gene- environment discordance observed in dark skinned populations in the~     US be a risk factor for metabolic disorders? Ultimately, the public health community and~     regulatory bodies must offer recommendations for optimal levels and supplementation. The~     investigators propose to utilize cohorts from an ongoing NIH-funded study designed to~     identify determinants of weight change and cardiovascular disease risk in five Afro-origin~     populations [Modeling the Epidemiologic Transition Study (METS)] to examine these questions.~     The five METS countries include Ghana, Seychelles, South Africa, Jamaica and the US; the five~     populations differ greatly in terms of sun exposure and dietary intakes. In addition to the~     extensive energy expenditure, dietary intake and obesity-related metabolic markers being~     measured in METS, the investigators propose to assess plasma 25(OH)D, iPTH, serum and urinary~     calcium, plasma markers of bone resorption and formation, and quantitative ultrasound of the~     calcaneus. The associations of adiposity, weight change, cardiovascular disease (CVD) risk~     factors such as blood pressure and insulin, and bone strength with 25(OH)D and iPTH will be~     assessed. The proposed study will provide a comprehensive assessment of the distribution and~     determinants of 25(OH)D-iPTH and related physiologic measures across a wide range of latitude~     and lifestyles. These data should contribute substantially to the understanding of the~     normal range within which these hormones function and their significance in Afro- origin~     populations.~   "
111206|NCT02111889|"~     The investigators hypothesize that response to kinase inhibitors is dependent on achieving~     pharmacological active drug levels in tumor tissue and that quantitative PET imaging can~     predict kinase inhibitors tumor concentrations. The ultimate aim is to develop a quantitative~     PET based imaging tool to differentiate between patients who will respond to therapy with~     kinase inhibitors.~      The main objective of this study is to determine whether tumor concentrations of kinase~     inhibitors at pharmacological active doses can be predicted from PET studies using tracer~     amounts (microdosing) of corresponding radiolabeled kinase inhibitors. This objective~     includes the development and validation of pharmacokinetic models for radiolabeled kinase~     inhibitors as well as validation of the microdosing concept for kinase inhibitors.~   "
111207|NCT02111876|"~     There is currently no good description of patients surviving an episode of acute hypercapnic~     respiratory failure in the ICU. For instance, the prevalence of OSA and sleep hypoventilation~     in a stable clinical condition is not known in this population.~      This prospective cohort describes the clinical profile, predictors of readmission (followed~     over a year), and the prevalence of sleep-related breathing disorders (polysomnography in a~     stable clinical condition 3 months after ICU discharge) in patients treated for an episode of~     acute hypercapnic respiratory failure in the ICU.~   "
111208|NCT02111863|"~     Background:~      The National Cancer Institute (NCI) Surgery Branch has developed an experimental therapy that~     involves taking white blood cells from patients' tumors, growing them in the laboratory in~     large numbers, and then giving the cells back to the patient. These cells are called Tumor~     Infiltrating Lymphocytes, or TIL and we have given this type of treatment to over 100~     patients. In this study, we are selecting a specific subset of white blood cells from the~     tumor that we think are the most effective in fighting tumors and will use only these cells~     in making the tumor fighting cells.~      Objective:~      The purpose of this study is to see if these specifically selected tumor fighting cells can~     cause melanoma tumors to shrink and to see if this treatment is safe.~      Eligibility:~      - Adults age 18-70 with metastatic melanoma who have a tumor that can be safely removed.~      Design:~        -  Work up stage: Patients will be seen as an outpatient at the National Institutes of~          Health (NIH) clinical Center and undergo a history and physical examination, scans,~          x-rays, lab tests, and other tests as needed~        -  Surgery: If the patients meet all of the requirements for the study they will undergo~          surgery to remove a tumor that can be used to grow the TIL product.~        -  Leukapheresis: Patients may undergo leukapheresis to obtain additional white blood~          cells. {Leukapheresis is a common procedure, which removes only the white blood cells~          from the patient.}~        -  Treatment: Once their cells have grown, the patients will be admitted to the hospital~          for the conditioning chemotherapy, the tumor infiltrating lymphocytes (TIL) cells and~          aldesleukin. They will stay in the hospital for about 4 weeks for the treatment.~      Follow up: Patients will return to the clinic for a physical exam, review of side effects,~     lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1~     year as long as their tumors are shrinking. Follow up visits take up to 2 days.~   "
111209|NCT02111850|"~     Background:~      The NCI Surgery Branch has developed an experimental therapy for treating patients with~     metastatic cancer that involves taking white blood cells from the patient, growing them in~     the laboratory in large numbers, genetically modifying these specific cells with a type of~     virus (retrovirus) to attack only the tumor cells, and then giving the cells back to the~     patient. This type of therapy is called gene transfer. In this protocol, we are modifying the~     patient s white blood cells with a retrovirus that has the gene for anti-MAGE-A3-DP0401/0402~     incorporated in the retrovirus.~      Objective:~      The purpose of this study is to determine a safe number of these cells to infuse and to see~     if these particular tumor-fighting cells (anti-MAGE-A3-DP0401/0402 cells) cause tumors to~     shrink and to be certain the treatment is safe.~      Eligibility:~      - Adults age 18-70 with metastatic cancer expressing the MAGE-A3 molecule.~      Design:~        -  Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and~          undergo a history and physical examination, scans, x-rays, lab tests, and other tests as~          needed~        -  Leukapheresis: If the patients meet all of the requirements for the study they will~          undergo leukapheresis to obtain white blood cells to make the anti-MAGE-A3-DP0401/0402~          cells. {Leukapheresis is a common procedure, which removes only the white blood cells~          from the patient.}~        -  Treatment: Once their cells have grown, the patients will be admitted to the hospital~          for the conditioning chemotherapy, the anti-MAGE-A3-DP0401/0402 cells and aldesleukin.~          They will stay in the hospital for approximately 4 weeks for the treatment.~        -  Follow up: Patients will return to the clinic for a physical exam, review of side~          effects, lab tests, and scans about every 1-3 months for the first year, and then every~          6 months to 1 year as long as their tumors are shrinking.~   "
111210|NCT02111837|"~     This is a multicenter, randomized, double-blind, parallel-group, reference-controlled 4-month~     pilot safety study to evaluate the effects of specific lipid fractions-enriched infant~     formulae on growth of infants aged 0-4 months. The study will test the hypothesis that growth~     of infants fed the specific lipid fractions-enriched infant formulae will be noninferior to~     growth of infants fed standard infant formula.~   "
111211|NCT02111824|"~     The goal of this clinical research study is to test the use of a minimally invasive~     multimodality image-guided (MIMIG) intervention system used for performing a lung biopsy. The~     safety of the MIMIG intervention system will also be studied.~   "
111212|NCT02111811|"~     The purpose of this research study is to test the effectiveness of a new telephone counseling~     program for employed Veterans with depression called the Veterans Work and Health Initiative~     (V-WHI). 250 participants will be recruited and randomly assigned to one of two groups: the~     V-WHI experimental group or usual mental health care. The V-WHI counselors will address~     mental health and job-related issues that interfere with working. This counseling is provided~     solely over the phone with sessions every 2 weeks for 4 months (eight sessions total). At 8~     months post-baseline, the V-WHI group is provided with a booster session. Participants in~     both groups are administered follow-up questionnaires at two time-points: month five and~     month nine.~   "
111213|NCT02111798|"~     This project will examine effects of bupropion extended release (XL) at a dose of 300mg/day~     on initiation and maintenance of cocaine abstinence in a population of cocaine dependent~     methadone maintenance patients (N = 200) who can earn financial incentives for stopping their~     cocaine use. Bupropion is a promising medication for this purpose because of its previously~     demonstrated efficacy and safety as well as its pharmacological actions at dopamine systems.~     The study will use a stratified randomization strategy that will allow us to separately~     examine bupropion effects on abstinence initiation and relapse prevention. Outcomes will be~     tracked over a 6-month time frame that includes assessment of drug use during and after~     incentives have stopped. In addition, the project will provide novel information about~     mechanisms of medication effects by measuring subjective drug effects, drug vs money choices,~     and self-reports of pleasure derived from daily non-drug activities. The investigators~     hypothesis is that bupropion as compared to placebo treatment will both enhance rates of~     abstinence initiation in those who have difficulty stopping cocaine and retard rates of~     relapse in those who initially stopped their cocaine use. Furthermore that bupropion compared~     to placebo participants will report non-drug activities as more pleasurable (reinforcing),~     will engage in more of them. If hypothesized synergies are demonstrated, the study will point~     the way to a significant advance in improved treatment strategies for this critical group of~     drug abusers.~   "
111214|NCT02111785|"~     Chronic subdural hematoma (cSDH) is condition where blood has slowly leaked out of small~     blood vessels surrounding the brain. Over time, the blood may cause a variety of symptoms~     including headache, confusion, limb weakness, and difficulty speaking.~      There is currently no agreement among physicians as to the best way to treat this condition.~     One option is to do a surgery to drain the blood that has collected. Usually the surgery~     involves drilling small holes in the skull to relieve pressure and allow blood and fluids to~     be drained. Another option is to give medications such as steroids that might reduce the~     swelling. However, no drugs have been approved by the Food and Drug Administration (FDA)~     specifically to treat this condition. Some patients elect to have no treatment.~      The purpose of this study is to investigate whether investigational treatment with a 2 week~     course of oral dexamethasone is as effective as surgery for cSDH. The study hypothesis to be~     tested is: For patients with unilateral, symptomatic chronic subdural hematoma, there is no~     difference in clinical outcomes, as measured by achievement of modified Rankin Score of 0-2~     at 6 months, between those treated with a 2 week course of oral dexamethasone, compared with~     those treated with burr hole surgical drainage.~   "
111215|NCT02111772|"~     In patients with asthma, reactions to allergens in the environment (such as mold, pollen,~     weed, domestic pets, and dust allergens) play an important role in causing asthma symptoms.~     However, upper respiratory tract infections, typically those caused by the common cold virus,~     rhinovirus, can also cause asthma to get worse. In previous studies at the University of~     Virginia, it was found that mild asthmatics, who had high levels of the allergy antibody~     (called IgE) in their blood, developed more persistent cold and chest symptoms when they were~     given an infection with rhinovirus (the most frequent cause of the common cold). The cold~     symptoms produced by rhinovirus tend to peak during the first 4 -7 days of the cold. These~     symptoms, including nasal congestion, are similar to what you have experienced with previous~     colds.~      This study is being done to learn how a common cold caused by a viral infection affects~     people with asthma. The goal is to learn how to improve the care of asthma symptoms caused by~     the common cold virus (called rhinovirus). Most adults experience one or two colds caused by~     rhinovirus every year. In addition, 75-80% of asthma exacerbations caused by viral infections~     are caused by this virus, primarily in children. Adults are less likely to experience~     significant changes in their asthma symptoms when they get colds, because they have developed~     protective immune responses from previous colds which help diminish symptoms.~   "
111216|NCT02111759|"~     The purpose of this study is to conduct a randomized controlled trial to determine if the~     knee flexion angle (KFA) during anterior cruciate ligament reconstruction (ACLR) graft~     fixation has an effect on postoperative outcomes. The specific research questions are: what~     is the effect of the KFA on 1) patient-reported outcomes; 2) postoperative extension loss; 3)~     antero-posterior (AP) knee stability; 4) rate of re-operation.~   "
111217|NCT02111746|"~     The purpose of this study is to assess the efficacy of the intraoperative injection of~     prolonged acting (liposomal) bupivacaine in postoperative pain control after truncal surgical~     incisions.~   "
111218|NCT02111733|"~     Evaluation of High sensibility troponin levels modification by hemodialysis in terminal renal~     failure patient at Sherbrooke University Hospital Center as determined by serial~     measurements. Verification of potential effects of these levels and their variation as~     predictors of cardiovascular outcomes and events at 6 and 12 months.~   "
111259|NCT02111187|"~     This trial is designed as a randomized two-arm (LDE225 vs. observation groups) open-label~     prospective clinical trial in men with localized high-risk prostate cancer undergoing radical~     prostatectomy.~      The investigators propose to determine the effects of LDE225 on neoplastic prostate tissue~     from men at high risk of systemic disease progression, by comparing pre-surgical core-biopsy~     specimens to tumor tissue harvested at the time of prostatectomy.~   "
111375|NCT02109653|"~     This is an open-label, multi-center, single arm phase II study to evaluate the efficacy and~     safety of novel BRAF (B-raf murine sarcoma viral oncogene homolog B1) inhibitor encorafenib~     (LGX818) when used as single agent in patients with advanced or metastatic (stage IIIB or IV)~     BRAF V600 mutant NSCLC. Patients must have progressed on or after at least one previous~     systemic, anti-cancer therapy for locally advanced or metastatic NSCLC.~   "
111219|NCT02111720|"~     The decision to disclose one's serostatus to family members creates considerable emotional~     strain for people living with HIV (PLWH), regardless of gender and sexual orientation. While~     disclosure to family members has been linked to positive outcomes including increased social~     support, improved health outcomes (i.e., sexual, physical, mental), reduced loneliness and~     stress, and improved HIV disease management, the decision not to disclose can also lead to~     positive outcomes. To date, most research about serostatus disclosure has focused on the act~     of disclosing - the who, what, where, and when of disclosing - rather than the decision~     process involved. The investigator's long-range goal is to further refine and evaluate an~     intervention designed to enhance HIV disclosure decision-making among PLWH. To reach this~     goal, the investigators are proposing a course of study with the following specific aims:~     Specific Aim 1. Assess the effectiveness of the intervention relative to an attention-control~     condition on a variety of primary outcomes related to disclosure and health. Specific Aim 2:~     Examine the effects of the intervention over time. Specific Aim 3: Explore the potential~     mediating effects of disclosure decision making on the primary outcomes. Specific Aim 4:~     Explore potential moderating effects of participant demographics (e.g., gender, age),~     relationship characteristics (i.e., relationship satisfaction, proximity, importance of~     disclosure), and contextual variables related to family (e.g., adaptability, problem-solving)~     on intervention effectiveness. Specific Aim 5: Evaluate the effects of treatment engagement,~     retention and expectations on outcomes.~   "
111220|NCT02111707|"~     To determine if the timing of administration of indomethacin affects the primary outcome of~     post-ERCP pancreatitis (PEP). Patients undergoing ERCP will be randomly assigned to receive~     pre or post-procedure rectal indomethacin to prevent the occurrence of PEP.~   "
111221|NCT02111694|"~     The objective of the proposed research is to conduct a within-subject, experimental study~     that will describe mothers' feeding practices during typical bottle-feeding conditions and~     will examine whether removal of visual cues related to the amount of milk/formula in the~     bottle will alter these feeding practices. The investigators hypothesize that mothers will~     show higher levels of infant-directed feeding practices and lower levels of mother-directed~     feeding practices when using opaque, weighted bottles compared to when using standard, clear~     bottles. The investigators also hypothesize that infants will consume less breast milk or~     formula when fed from opaque, weighted bottles compared to when fed from standard, clear~     bottles.~   "
111222|NCT02111681|"~     The purpose of this study is to test the use of Calypso beacon implants as a way to determine~     where the lung tumor is located during radiation treatment. The Calypso beacons are small~     devices that are implanted in the lungs, near the tumor. They are able to send a signal to a~     tracking system to show where they are, and where the tumor is, as the patient holds their~     breath for the radiation treatment. The investigators want to find out what effects, good~     and/or bad, that this has on the patient and the way they treat the cancer in your lungs.~   "
111223|NCT02111668|"~     Aortic dilatation syndromes are comprised by a group of different syndromes, of which Marfan~     syndrome is the best described. Many of the aorta dilatation associated syndromes are~     heritable connective tissue disorders but some patients do not have any other phenotypical~     symptoms than aorta dilatation. The genetic variation in thoracic aorta dilatation is still~     unknown. This study aims on genetic evaluation of patients with thoracic aorta dilatation.~     Furthermore the study will focus on a registry angel trying to evaluate prevalence,~     mortality, morbidity and socioeconomically status of Marfan syndrome patients. This part will~     rely on registry data obtained from unique Danish registries.~   "
111224|NCT02111655|"~     All vascular access guidelines recommend monitoring and surveillance protocols to prevent~     vascular access complications in hemodialysis units.~      However, in the case of second generation screening techniques which determine access blood~     flow measurement (QA), there is a huge controversy about it´s efficiency.~      Although multiple observational studies find a decrease in the thrombosis rate and an~     increased primary assisted patency survival related to the use of these techniques, a~     recently published meta-analysis find contradictory results in the randomized controlled~     trials, affirming that the measurement of QA is useless in grafts and questionable in native~     arteriovenous fistulae (AVF).~      We have designed a multicenter, prospective, open label, controlled, randomized trial, to~     prove the usefulness of the QA measurement using two complementary second generation~     techniques, Doppler ultrasound and Transonic dilution method, compared to the classical~     monitoring and surveillance methods.~      The primary endpoint will be a reduction in the thrombosis rate with an increased assisted~     primary patency survival, and a cost effectiveness economic analysis.~      As secondary endpoints we will analyze the impact over non-assisted primary patency survival~     and secondary patency survival.~   "
111225|NCT02111642|"~     Pelvic organ prolapse occurs with descent of one or more pelvic structures: the uterus and/or~     cervix, bowel, bladder, or rectum. Although options for treatment include expectant~     management, pelvic floor physical therapy, and pessary (intravaginal device) use, surgery is~     the only option which potentially offers a cure.~      It is well known that women with pelvic organ prolapse are at risk of developing new stress~     urinary incontinence symptoms after prolapse surgery. Stress urinary incontinence is defined~     as involuntary loss of urine with an increase in intra-abdominal pressure, such as sneezing,~     coughing, or laughing. Previous studies have demonstrated that the addition of a prophylactic~     anti-incontinence procedure at the time of prolapse surgery reduces this risk. One example of~     such a procedure is a mesh sling placed underneath the urethra (midurethral sling).~     Nevertheless, the decision to place a midurethral sling to prevent stress urinary~     incontinence after prolapse surgery remains controversial.~      A new risk calculator tool has been developed to provide patients' with their individualized~     risk of developing de novo stress urinary incontinence after prolapse surgery. The primary~     objective of this study is to determine whether use of this new personalized online risk~     calculator tool increases patient satisfaction with the decision whether or not to have a~     midurethral sling placed at the time of prolapse surgery to prevent development of stress~     urinary incontinence. The investigators hypothesize that use of this tool will increase~     patient satisfaction with their decision regarding midurethral sling placement.~   "
111294|NCT02110732|"~     The purpose of this study is to evaluate the effect of oral administration of probiotic~     Lactobacillus rhamnosus GG in middle ear and adenoid tonsil.~   "
111226|NCT02111629|"~     Genital tract infections (GTIs) have increased in the past decade and there is an association~     between sexually transmitted infections (STIs) and other infections like bacterial vaginosis~     (BV), with the HIV transmission. BV and Candida are the most common causes of vaginal~     infections in symptomatic women, the prevalence of BV being 22-50% and the prevalence of~     Candida 17-39%. In an effort to reduce the transmission of GTIs, the World Health~     Organization (WHO) proposed a syndromic diagnostic approach as a low cost alternative in~     places with no access to laboratory diagnostic tests.~      Justification. In patients with syndrome of vaginal discharge, an effective treatment against~     Candida albicans, Trichomonas vaginalis, and bacterial vaginosis is adviced, therefore, for~     syndromic management of symptomatic vaginal discharge the combination of fluconazole and~     secnidazole could be used. No studies evaluating this combination were found in the~     literature reviewed.~      Objectives: To describe the safety and the clinical and microbiological efficacy of a single~     oral dose of a combined treatment with secnidazole + fluconazole for the syndromic management~     of symptomatic vaginal discharge.~      Methods: Design: open label, uncontrolled clinical trial to estimate clinical efficacy and~     safety of the combination of fluconazole and secnidazole for the treatment of symptomatic~     vaginal discharge. The participants will be sexually active women with lower genital tract~     symptoms (leukorrhea, itching, burning, pain, foul-smelling vaginal discharge, or urethral~     symptoms) compatible with symptomatic vaginal discharge syndrome. The study will be conducted~     in an outpatient service of a hospital in Bogota, Colombia. Given the descriptive character~     of the study, no a priori hypothesis is considered. A consecutive convenience sample size of~     100 symptomatic patients is calculated. The statistical analysis will be performed with STATA~     11.0 software (College Station, Texas, USA). Simple and relative frequencies and measures of~     central tendency and dispersion appropriate for the distribution of the variables will be~     calculated. The study has been submitted and approved by the Ethics Committee of the Faculty~     of Medicine of the National University of Colombia and the Institutional Review Board of the~     participating institution. All women must sign a written informed consent form agreeing to~     voluntarily participate in the study.~   "
111227|NCT02111616|"~     Purpose: Cancer survivorship is a high clinical and research priority both nationally and at~     the University of North Carolina. The investigators propose a randomized pilot study testing~     the development, implementation and evaluation of a parallel patient and streamlined provider~     version of a personalized Survivorship Care Plan (SCP) with lung cancer patients.~      Participants: 60 lung cancer patients at Rex Cancer Center.~      Procedures (methods): Participants will be recruited and randomized to the standard of care~     (30 patients) or intervention (30 patients) arm. Patients randomized to standard of care will~     receive a tailored survivorship care plan at the end of cancer treatment. Patients randomized~     to the intervention will receive a care plan and coordinating visit with their primary care~     provider. Patients will be invited to complete baseline and follow-up assessments regarding~     care needs and confidence in post cancer care.~      All patient primary care providers will receive condensed provider versions of the care plan.~     Providers will be asked to evaluate how the SCP and coordinated care visit (intervention~     only) facilitated communication and coordination of care.~   "
111228|NCT02111603|"~     The investigators' hypothesis is that therapy with Colesevelam, reduces fecal bile acid~     excretion in patients with Irritable Bowel Syndrome (IBS)-diarrhea with prior evidence of~     increased fecal 48 hour total bile acid excretion. The investigators aim to study the ability~     of the HPLC assay for fecal bile acids to demonstrate responsiveness after treatment with~     Colesevelam.~   "
111229|NCT02111590|"~     The aim of this study is to evaluate development of hemolysis and the variation in isokinetic~     muscle strength in two groups of patients with chronic inflammatory demyelinating~     polyneuropathy (CIDP) or multifocal motor neuropathy (MMN)~        1. Patients shifted from 3- or 6-weekly treatment with intravenous immunoglobulin (IVIG) to~          weekly treatment with subcutanoeus immunoglobulin (SCIG)~        2. Patients shifted from SCIG treatment with Subcuvia® or Hizentra® to Gammanorm®.~      Hypotheses~        -  During treatment with IVIG blood hemoglobin will fluctuate with a decline due to~          infusion, whereas it will remain stable during SCIG treatment without fluctuation~        -  Isokinetic muscle strength in affected muscle groups is more stable during treatment~          with SCIG than with IVIG~        -  Blood hemoglobin and changes in muscle strength is comparable during Subcuvia® or~          Hizentra® and Gammanorm® treatment~   "
111230|NCT02111577|"~     The purpose of this study is to determine whether DCVAC/PCa added onto Standard of Care~     Chemotherapy can improve survival times for patients with Metastatic Castration Resistant~     Prostate Cancer.~   "
111231|NCT02111564|"~     The purpose of this study is to evaluate the efficacy and safety of rivaroxaban compared with~     placebo in the prevention of symptomatic venous thromboembolism (VTE) events and VTE-related~     death post-hospital discharge in high-risk, medically ill patients.~   "
111232|NCT02111551|"~     This study plans to learn more about whether a nicotine-like investigational new drug, DMXB-A~     [3-(2,4-dimethoxybenzylidene) anabaseine] may have positive effects on mental focus and may~     help us to find new types of treatment for autism spectrum disorder. Subjects will come in~     for a screening visit and three more drug visits. There will be at least one week between~     each drug visit to allow the drug to be eliminated from your system completely. During each~     drug visit subjects will receive either a placebo (a capsule that looks like medicine but is~     not real), 75 mg of DMXB-A, or 150 mg of DMXB-A. During the drug day vital signs and well~     being will be monitored by the study physician. Subjects will complete some paper and pencil~     tasks to test memory, attention, speed, and problem solving, some rating scales and~     questionnaires, and the study team will record brain wave patterns with an~     electroencephalogram (EEG) .~   "
111233|NCT02111538|"~     Malnutrition is a prominent clinical feature of patients affected by systemic immunoglobulin~     light-chain amyloidosis (AL), with a prevalence ranging between 25-50%. Although the~     prognosis predominantly depend on the presence and severity of cardiac involvement, it was~     shown that malnutrition is an independent predictor of survival and quality of life. However,~     the assessment of nutritional status by common indices based on anthropometry is not always~     feasible and accurate due to reduced performance status and/or the presence of fluid~     imbalances (for example edema and ascites). Several recent studies have demonstrated the~     prognostic value of the phase angle. Moreover, the value is supported by its applicability to~     patients who are bedridden or present alterations in the state of hydration.~   "
111234|NCT02111525|"~     The purpose of this study is to determine the distribution of lung fluid status as reported~     by the IMED-4 system in patients presenting to the emergency department or urgent care~     facility with shortness of breath.~   "
111386|NCT02109510|"~     Investigators compared the patients' subjective postoperative symptoms and complications~     between the double lumen endotracheal intubated patients under general anesthesia and~     non-intubated patients under sedation and local anesthesia including~        1. postoperative Visual scale of pain~        2. postoperative sore throat/voice change~        3. postoperative nausea/vomiting~        4. intraoperative Arterial blood gas analysis~        5. cost for anesthesia~        6. morbidity~   "
111235|NCT02111512|"~     Egg allergy is common in early childhood, affecting at least one in 50 preschool children.~     Influenza ('flu) vaccines contain egg protein, as the vaccine is cultured in hen's eggs.~     There is robust data to support the safety of influenza vaccines (containing low or~     negligible amounts of egg protein) in patients with egg allergy.~      A new influenza vaccine, known as LAIV (Live Attenuated Intranasal Vaccine) has recently been~     approved by a number of licensing boards and is given by a spray into the nose. This new~     vaccine has been available in the United States for several years and is highly effective and~     against influenza infection, with an excellent safety profile in children without egg~     allergy. However, LAIV is also grown in hen's eggs and contains egg protein, and there are NO~     published data on the safety of LAIV in egg-allergic children. In SNIFFLE 1 Study, 433 doses~     were given to 282 egg-allergic children; data is currently being analysed.~      The objective of this multicentre study is to further assess the safety of intranasal LAIV in~     egg-allergic children, in order to demonstrate that these children can safely be given the~     new LAIV within a primary care health environment.~   "
111236|NCT02111499|"~     Clinical investigation of anti-psoriatic efficacy and atrophy~   "
111237|NCT02111486|"~     This clinical trial is being conducted to study whether eating certain meals will reduce your~     desire to eat and for a longer period of time compared to others and to determine the~     post-meal glucose response associated with each of these breakfast foods.~   "
111238|NCT02111473|"~     The study is designed to answer the following questions:~      1) What is the effect of testosteron replacement treatment on the endothelial dysfunction.~      2/ What is the effect of testosteron replacement on the bone mineral metabolism.~   "
111239|NCT02111460|"~     This is a randomized parallel control trial to evaluate whether radical loco-regional~     Radiotherapy can prolong survival time of initial untreated metastatic nasopharyngeal~     carcinoma.~   "
111240|NCT02111447|"~     Children who receive general anesthesia may become agitated (emergence delirium) in the~     recovery period. This occurs more often after inhalational anesthetics, particularly~     sevoflurane and desflurane than after propofol. However, agitation after anesthesia in~     children may be difficult to distinguish from pain; accordingly studies are ideally designed~     during MRI to obviate the contribution of pain during emergence. Airway complications have~     been reported after LMA and isoflurane more commonly than with IV propofol and nasal prongs.~     Whether the airway complications were due to the LMA or the isoflurane was unclear.~     Therefore, this study was designed to study the incidence of 1. agitation after sevoflurane~     compared with IV propofol and 2. airway complications after LMA or nasal prongs.~   "
111241|NCT02111434|"~     The study is designed to answer the following questions:~        1. What is the levels of visceral adiposity index and Triglycerides/HDL cholesterol ratio~          in hypogonadism?~        2. What is the effect of testosterone replacement on the visceral adiposity index and~          Triglycerides/HDL cholesterol ratio?~   "
111242|NCT02111421|"~     Currently, spinal anesthesia is most commonly used for cesarean section.But spinal anesthesia~     can not block the visceral vagus nerve, and the patients are prone to nausea, vomiting, chest~     tightness or other discomfort when the uterus is stretched .For parturients who have poor~     uterine contractions and are bleeding larger, obstetricians often use oxytocin to strengthen~     the contraction of the uterine,which also would increase the parturients'~     discomfort.Anesthesiologists often intravenous sedative hypnotics (eg.propofol or midazolam)~     to alleviate the fear of the parturients after the baby is delivered.One of the side effects~     of propofol or midazolam is that they would lead to the respiratory depression.For the poor~     respiratory reserve of the parturients, functional residual capacity(FRC) of this group could~     be reduced by up to 20%, and the oxygen consumption was also increased.The SPO2 could decline~     quickly intraoperatively.Dexmedetomidine is a novel , highly selective α2 adrenergic receptor~     agonists , and its selectivity for α2 receptor is 1600 times higher than α1.It also could~     provide dose-dependent sedation , analgesia , anti-anxiety and inhibition of sympathetic~     nerves and other effects.Because of its minimal impact on the respiratory , it could safely~     and effectively used to sedate patients undergoing cesarean section.But the change of~     endocrine system and hemodynamic of the parturients may affect the pharmacokinetics and~     pharmacodynamics of some anesthetic drugs.Currently studies have demonstrated the increased~     sensitivity of some anesthetic drug in parturients, such as lidocaine and isoflurane.The~     study is aim to explore the optimal dexmedetomidine dose to produce suitable sedation in~     parturients ,and compared with norman nonpregnant women.~   "
111243|NCT02111408|"~     The purpose of this study is to investigate sleep disordered breathing, autonomic~     dysfunction, and post stroke depression in acute and chronic stroke patients. Furthermore, to~     explore the interaction between these comorbidities, and their relation to stroke aetiology.~   "
111244|NCT02111382|"~     Osteopathic medicine is based on a diagnostic and therapeutic system to treat tissue~     mobility/ motility dysfunctions in general, using different approaches (depending on the~     target tissue) known as osteopathic manipulative treatment.~      Among all the available techniques those ones addressed to the cranial field are most~     questioned because of the lack of scientific evidence; but the compression of the 4th~     ventricle technique has been largely studied in clinical trials. Studies have shown that the~     technique may affect both central and autonomous nervous system, modulating some reflexes~     (Traube-Hering baro signal), and modifying brain cortex electrical activity through central~     sensitization in subjects with chronic low back pain.~      Thus, investigators hypothesize that the compression of the 4th ventricle may modulate peak~     alpha frequency (electroencephalographic assessment) and promote physical relaxation in~     subjects in vigil.~   "
111295|NCT02110719|"~     In recent years, there has been an emphasis on the creation of enhanced-recovery,~     fast-track or multi-modal pathways to improve perioperative care (1-4). The goal of these~     programs is to reduce the length of hospital stay, decrease narcotic usage while improving~     pain control, accelerate post-operative recovery, and expedite return to baseline functional~     status. Pathways often are developed by a team of surgeons, nurses, pain specialists,~     anesthesiologists and other support staff. Postoperative components often involve multi-modal~     analgesia, early return to activity and early return to a regular diet. The goal of this~     study is to evaluate the efficacy of a multi-modal pain regimen in advanced pelvic surgery~     with a primary goal of decreasing narcotic usage.~   "
111387|NCT02109497|"~     This study is designed to determine the pharmacokinetic (PK) profile of a single oral dose of~     caffeine and the effects that PBT2 has on the metabolism of caffeine in healthy volunteers.~   "
111245|NCT02111369|"~     Essential tremor is the most common adult-onset movement disorder, and essential voice tremor~     is the vocal manifestation of essential tremor. While nearly all essential tremor patients~     experience hand tremor, many also manifest head tremor and voice tremor. Essential voice~     tremor can lead to increased vocal effort, decreased intelligibility, and misconstrued~     emotional state. Only one medication, propranolol, is FDA-approved to treat essential tremor.~     Propranolol is not felt to be nearly as effective for axial tremors (head, trunk, neck) as it~     is for extremity tremors. However, this has not been studied with any objective assessment in~     a prospective way for EVT. For patients with essential voice tremor, the limited published~     data suggests that botulinum toxin has been shown to lead to functional voice improvement.~     Botulinum toxin, though also not well-studied with objective voice outcomes, is a commonly~     used clinical therapy for treatment of essential voice tremor. While it is used more often~     for essential voice tremor than propranolol therapy, botulinum toxin also has not been~     prospectively studied with validated, objective voice outcome measures. The investigators~     would like to determine if propranolol has any significant effect on vocal tremor. The~     investigators would also like to determine, in an objective way, the effect of botulinum~     toxin on vocal tremor. If effective, propranolol would provide an affordable and non-invasive~     alternative or addition to botulinum toxin injections for patients with essential voice~     tremor.~   "
111246|NCT02111356|"~     Pinhole glasses which is using pinhole effect may induce a functional change on the eyes,~     including Distance and near visual acuity(DVA, NVA), Pupil size, DOF, Accomodative amplitude,~     CS, Visual field(VF), Stereopsis.~   "
111247|NCT02111343|"~     The current study aimed to examine the effectiveness of a Computer-based auditory training~     (CBAT) intervention for children with Central Auditory Processing Disorder (CAPD) by~     comparing the changes in auditory processing (AP) and functional listening skills of these~     children immediately post-intervention, to that of the untrained controls. The AP skills of~     the trained group were evaluated again at 3 months post-intervention to examine the~     sustainability of any improvements made from the CBAT intervention. I hypothesised that after~     intervention, children from the auditory training (AT) group would improve in their AP~     skills, and that improvement would be greater than the changes in AP skills of those~     untrained controls. I also hypothesised that the improvement made from the intervention would~     sustain for at least 3 months after the end of intervention. Finally, I examined if the~     training outcomes are predictable from any underlying factors such as the initial AP,~     language, or cognitive skills of these children.~   "
111248|NCT02111330|"~     Study to assess the safety and tolerability of three doses of PBF-509 (80 mg, 160 mg and 240~     mg) after repeated (8 days) single daily oral dose administration in young male and female~     healthy subjects.~   "
111249|NCT02111317|"~     The purpose of this study is to evaluate the effect of verapamil, a P-glycoprotein (P-gp)~     inhibitor, on the pharmacokinetics of ASP015K. This study will also assess the safety and~     tolerability of ASP015K administered alone and also and in combination with verapamil.~   "
111250|NCT02111304|"~     The primary hypothesis is that administration of iOWH032 to adult and pediatric males and~     females with acute cholera due to V. cholerae O1 reduces stool output in the first 24 hours~     significantly more than does the current standard of care.~   "
111251|NCT02111291|"~     The current trial examines the potential benefits of continuous 12 week treatment with~     Santyl, measured in terms of wound bed appearance. The visual appearance of granulation~     tissue will be recorded at each visit for the purpose of examining the relationship between~     wound bed appearance and progress towards healing. In support of this longer treatment~     regimen with Santyl, a recent animal study found that application of Santyl for 12 weeks was~     safe and well tolerated. Therefore, the present study is designed to test the hypothesis that~     daily treatment of diabetic foot ulcers (DFU) with Santyl for up to 12 weeks will result in~     more rapid development of granulation tissue than DFU treated with supportive care.~   "
111252|NCT02111278|"~     The purpose of this study is to determine if the addition of lumbar manipulation will improve~     function, decrease pain, and recurrence in adolescents with low back pain. The secondary aim~     of this study is to determine if a modification of a clinical prediction rule by Flynn will~     be effective in identifying adolescent patients with low back pain who would benefit from~     lumbar manipulation.~   "
111253|NCT02111265|"~     Compare the efficacy and safety of closed-loop target controlled infusion of propofol or~     etomidate at general anesthesia in geriatric patients~   "
111254|NCT02111252|"~     This clinical trial is a phase 1/2 study of a single intramuscular injection of TAK-850 in~     healthy Japanese adult participants~   "
111255|NCT02111239|"~     The purpose of this study is to determine whether preoperative abdominal imaging using either~     CT angiogram (CTA), or MR angiogram (MRA) will impact perforator dissection time, cost, and~     patient outcomes in DIEP flap breast reconstruction.~   "
111256|NCT02111226|"~     Heart disease and stroke are the number one killers world-wide. When someone has~     hypertension, the constantly elevated blood pressure damages their blood vessels and the~     organs that they supply blood to. This causes stroke, heart attack, heart failure, kidney~     failure and dementia. Finding and lowering high blood pressure to normal with lifestyle~     changes and if necessary medications, lowers the risk of these outcomes. Canada has high~     rates of blood pressure control compared to other countries in the world, due in large part~     to the successful dissemination of hypertension guidelines. However remote and disadvantaged~     communities have not been as successful and need additional measures to help achieve the same~     level of blood pressure control as the rest of the country. The DREAM-GLOBAL team has~     extensive experience working with Canada's Aboriginal Communities and a large community in~     Tanzania. The DREAM-GLOBAL project will integrate innovations in technology with the~     implementation of guidelines-based blood pressure control and through partnerships with~     experts in government and industry, overcome barriers to lowering blood pressure in Canada's~     Aboriginal Communities, and in a community in Tanzania. Tools will be developed and tested~     that will close the circle of care around people with hypertension by bringing measurement~     data to the medical record and health care provider and also sending useful medical feedback~     to the person with hypertension via secure data servers and routine SMS messaging on cell~     phones. The system will be tested for effectiveness of diagnosing and also for managing~     hypertension. To begin the process of preventing hypertension, the team will also explore~     with an Aboriginal community how to create policies to reduce the sodium content in their~     food. If proven effective, DREAM-GLOBAL can also become a platform for managing other chronic~     diseases.~   "
111257|NCT02111213|"~     The primary aim of this research study is to evaluate the effectiveness of a computer-based~     'virtual lay advisor' intervention relative to a proven human lay advisor/promotore~     intervention to promote regular walking among inactive midlife and older Latino adults. The~     primary analysis is a non-inferiority analysis comparing these two interventions.~   "
111260|NCT02111174|"~     The purpose of this study is to see if Scrambler Therapy with the Calmare MC5-A machine will~     relieve chemotherapy induced peripheral neuropathy (CIPN).~      Scrambler Therapy is a method of pain relief given with common electrocardiography (ECG) skin~     electrodes. The electrodes are placed on the body in pairs, and the Scrambler Therapy machine~     directs electrical signals across the field to simulate non-pain information.~      Based on other studies, we think that we relieve pain with the Scrambler therapy device, but~     it has not been tested in a setting such as this one. This means that some of the pain relief~     could be due to placebo effect, or the CIPN pain going away on its own. In this study we want~     to compare the Scrambler Therapy with the sham therapy (the therapy that does not use the~     electrical signals). We hope that this study will help us determine if the Scrambler device~     really helps patients with CIPN.~      Cancer patients with chronic, chemotherapy-related pain of 4 or more (on a 0-10 scale) for at~     least 3 months may be eligible to join this study.~   "
111261|NCT02111161|"~     The purpose of this study is to estimate the effect of intravenous polyspecific~     immunoglobulin G (IVIG) compared with placebo (saline) on the patient-reported outcome~     measure Physical Component Summary Score (PCS) of the SF-36 in patients with necrotizing soft~     tissue infections (NSTI).~   "
111262|NCT02111148|"~     The investigators assess in this study the sensitivity of Urea and Creatinine and that of~     Nitrazine test in vaginal wash after injecting saline in the vagina of patients with~     pre-labour rupture of membranes~   "
111263|NCT02111135|"~     Phase II, observer-blind, randomized study on the safety, reactogenicity, immunogenicity and~     impact on intestinal shedding of a single dose of monovalent high-dose inactivated poliovirus~     type 2 vaccine (m-IPV2 HD) or a single dose of standard trivalent inactivated poliovirus~     vaccine (t-IPV) when given concomitantly with the third dose of bivalent oral poliovirus~     vaccine (b-OPV) to infants early in life~   "
111264|NCT02111122|"~     Sleep wake disturbance is a common problem in Parkinson`s disease patients and so far the~     therapeutic possibilities for symptomatic relief are limited. Small, open-label studies~     indicate that the use of Xyrem (gamma-hydroxybutyrate) might be of benefit in this situation.~      This study is intended to show a beneficial effect of the study medication in a randomized~     cross-over trial, that fulfills strict scientific criteria.~   "
111265|NCT02111109|"~     Haemorrhage following major trauma is an important preventable cause of death. Those patients~     who survive may have a prolonged period of debility caused by failure of key body organs. We~     suspect that an important contributor to this organ failure may be dysfunction in the network~     of small blood vessels that supply the bodies organs with oxygen and nutrients. Our study~     will examine the link between the microcirculation and organ failure in patients who have~     suffered significant bleeding after traumatic injury. We will also explore the relationship~     between resuscitation of the global circulation (blood pressure, cardiac output etc.)an area~     that is monitored in clinical practice with the state of the microcirculation, which by~     contrast is not monitored. Patients with severe traumatic injury commonly have problems with~     blood clotting. Some researchers have suggested that microcirculatory failure may be an~     important contributor to this problem and we will explore this in more detail. Finally, we~     will attempt to examine some of the mechanisms by which the microcirculation may be disrupted~     by trauma and subsequent bleeding. These may include inappropriate activation of white blood~     cells, inadequate function of oxygen carrying red blood cells and changes to the cells lining~     the small blood vessels.~      We will use a non invasive method to assess the microcirculation termed Side Stream Dark~     Field microscopy. This involves recorded a video image of the movement of blood within the~     small blood vessels under a patients tongue. In addition we will use ultrasound to assess the~     flow of blood from the heart. Small samples of blood will be taken to assess blood clotting~     and to look at possible mechanisms of microcirculatory dysfunction.~      We aim to study ten patients in the first instance. The study will be carried out within the~     intensive care units at Kings College Hospital.~   "
111266|NCT02111096|"~     The intent of this study is to assess the safety of LY2409021 in participants with Type 2~     diabetes mellitus taking metformin and sulfonylurea as prescribed by their personal~     physician. The study treatment is expected to last 12 months (52 weeks).~   "
111267|NCT02111083|"~     The study involves 4 injections of insulin lispro and its purpose is to:~        -  Determine if 2 formulations of insulin lispro are treated by the body in a similar way.~        -  Compare how the 2 formulations of insulin lispro affect blood sugar level.~        -  Determine the safety of each insulin lispro formulations and any side effects that might~          be associated with them when given to healthy participants. The study is expected to~          last up to approximately 9 weeks for each participant.~   "
111268|NCT02111070|"~     The purpose of this study is to evaluate the safety and immunogenicity of IL-YANG Inactivated~     Split Influenza Vaccine (IL-YANG FLU Vaccine Vial INJ.) administered as a single~     intramuscular injection~   "
111269|NCT02111057|"~     Researchers at the Hospital for Special Surgery are trying to learn more about post-operative~     rheumatoid arthritis flare (RA). This study hopes to understand RA flare after total joint~     replacement surgery and what the result of flaring is for patients over the next year. We~     will ask patients about their RA, whether it has gotten worse, and whether they are able to~     work with the physical therapist. During the course of this study, we'll be collecting~     questionnaires, and we'll be drawing blood to better understand what's going on with RA and~     with a patient's recuperation from their joint replacement.~      We want to understand whether a flare of RA might affect the outcome of a patient's joint~     replacement. We believe this study might show us how to better manage patients with~     rheumatoid arthritis following a joint replacement. If RA patients who flare are unable to~     participate in physical therapy and do worse after one year after a total hip replacement,~     more effective treatment could be developed. The study will also help us to identify early~     factors that may influence long-term outcomes of joint replacements in RA patients.~   "
111270|NCT02111044|"~     The purpose of this study is to investigate in acromegalic patients the effect of different~     doses of ITF2984 on GH and IGF-1 concentrations and to investigate safety and tolerability of~     three different doses of ITF2984.~   "
111271|NCT02111031|"~     The objective of the registry study is to demonstrate the clinical utility of the CELLSEARCH®~     CTC Test among the Medicare-Eligible metastatic Breast Cancer (mBC) patients in the United~     States. The objective of the present registry is to demonstrate the impact on patient~     management of the CELLSEARCH® CTC Test among the Medicare-eligible mBC patients. Hereto the~     hypothesis that the availability of CTC information provides clinicians important, timely~     information and impacts treatment decisions, will be tested.~      This study is IDE-exempt since CELLSEARCH® CTC Test is a legally marketed device in the US,~     and is being used in accordance with its labeling.~   "
111272|NCT02111018|"~     Prospective, randomized non-blinded, controlled study to assess the feasibility of the~     CytoSorb as an adjunct to the standard of care in patients with rhabdomyolysis requiring~     renal replacement therapy.~   "
111273|NCT02111005|"~     Apoptosis is an evolutionary form of physiological cell death. Studies suggest that apoptosis~     is involved in the pathogenesis of periodontal diseases. Human gingival fibroblasts (HGF)~     have an important role in the periodontal immune response. It is believed that HGF can be~     diminished and/or eliminated by means of apoptosis.~      Smoking is one of the most common risk factor of periodontal disease. Studies indicated that~     smoking can increase the risk of periodontitis by enhancing the apoptosis of gingival~     fibroblast.~      The purpose of this study is to determine and to investigate apoptosis of HGF in gingival~     biopsies collected from smokers and non smokers who are diagnosed with chronic periodontitis~     or aggressive periodontitis.~      Eighty subjects will be invited to participate in this study. Patients will be allocated into~     four groups (20 patients each). Gingival biopsies will be obtained from the base of papillae~     during surgical treatment (open flap curettage) and will be examined by Immuno-histochemical~     analysis. Immune-staining will be done using p53 monoclonal mouse anti-human antibody.~   "
111274|NCT02110992|"~     The purpose of this research study is to test the safety of a chemotherapy drug called~     docetaxel and focused radiation therapy (SBRT) and see what effects (good and bad) it has on~     recurrent head and neck cancer that is not surgically removable.~   "
111275|NCT02110979|"~     The objectives of this study are to compare measurements in knowledge of decision options,~     support for decision making, uncertainly in decision making, and clarity of values important~     to decision making among two groups of type 2 diabetes patients, those who receive a Patient~     Decision Aid and those who receive usual care.~   "
111276|NCT02110966|"~     The purpose of this study is to evaluate the success of inferior alveolar nerve block, after~     the local application of Mepivacaine plus Tramadol in patients with symptomatic irreversible~     pulpitis. Also, to evaluate the duration of the anesthetic effect when using Mepivacaine plus~     Tramadol in the same anesthetic technique and patients group.~      Hypothesis:~      Local application of mepivacaine plus tramadol increases the successful of inferior alveolar~     nerve block in patients with irreversible pulpitis.~   "
111277|NCT02110953|"~     This phase I trial studies the side effects and best dose of irinotecan-eluting beads in~     treating patients with colon or rectal cancer that has spread to the liver and does not~     respond to treatment with standard therapy. Irinotecan-eluting beads are tiny beads that have~     been loaded with irinotecan hydrochloride, a chemotherapy drug. Drugs used in chemotherapy,~     such as irinotecan hydrochloride, work in different ways to stop the growth of tumor cells,~     either by killing the cells or stopping them from dividing. This treatment delivers the~     chemotherapy directly to the tumor area inside the liver instead of to the whole body as with~     systemic delivery of the drug. Irinotecan-eluting beads may work better that standard~     chemotherapy in treating patients with colon or rectal cancer that has spread to the liver.~   "
111278|NCT02110940|"~     This clinical trial is the first study to apply neurodynamic mobilization, a nervous system~     specific therapeutic exercise, on patients with rheumatoid arthritis(RA). Objective of the~     study is to find out the effect of neurodynamic mobilization for joint inflammation in~     patients with RA.~   "
111279|NCT02110927|"~     The purpose of this study was to analyze microcurrent short term effects used with aerobic~     exercise on abdominal fat.~   "
111280|NCT02110914|"~     The treatment burden for patients with cystic fibrosis (CF) is significant and poor adherence~     has been well-documented. The investigators hypothesize that a coaching intervention will~     empower young adults with CF to manage their lives with CF and improve health-related quality~     of life (HRQoL). The main aim of the study is to establish the feasibility and acceptability~     of a life-coaching intervention.~   "
111281|NCT02110901|"~     This research study is designed to assess the safety and effectiveness of an experimental~     drug called PRT-201 in patients both receiving or expecting to receive dialysis who have~     chronic kidney disease and who are undergoing surgery to create a new access point to their~     bloodstream for hemodialysis. PRT-201 is a protein that has been shown in previous research~     studies to help keep vessels patent when applied to the outside surface of the blood vessels~     (arteries and veins) in patients who undergo surgery to create an arteriovenous fistula~     (AVF). The purpose of this study is to determine whether PRT-201 when applied to a limited~     segment of your blood vessel (about 2 inches) immediately after surgery is safe and improves~     the patency of your AVF.~   "
111282|NCT02110888|"~     Despite globally favourable outcomes of Spinal Cord Stimulation (SCS), a significant~     proportion of Failed Back Surgery Syndrome (FBSS) patients do not obtain adequate coverage of~     low back pain. Peripheral Nerve Stimulation (PNS) has obtained the European Conformity mark~     for the treatment of chronic refractory neuropathic pain and is now commonly used in some~     countries to target back pain. However, the potential value of combining SCS and PNS as~     hybrid stimulation remains poorly described with only isolated case reports or limited~     experience in various indications.~      The CUMPNS comparative randomized study is designed to demonstrate the potential analgesic~     efficacy of PNS in addition to previously implanted SCS, to treat the residual low back pain~     component pain in refractory FBSS patients.~   "
111283|NCT02110875|"~     The purpose of this study is to learn more about balance and strength in an elderly~     population (60 and older). Data will be compared between controls and the age/gender- matched~     PD participants in study The Effects of vitamin D on Balance in Parkinson's disease (OHSU~     IRB # 6482). Specifically a t-test will be used to compare total work and total power on leg~     extension and flexion, composite SOT score conditions 1-3 and 4-6, response strength and~     latency on MCT, and turn duration from the iMOBILITY between the two groups.~   "
111284|NCT02110862|"~     The aim of this study is to evaluate scintigraphic methods as objective factors for~     functional outcome in patients treated with ileal-pouch-anal anastomosis (IPAA). The~     gastrointestinal transit-time and the degree of evacuation are evaluated in relation to the~     functional outcome.~   "
111285|NCT02110849|"~     To prospectively collect data from patients treated with proton therapy for prostate cancer~     using the IUHPTC technique for the evaluation of toxicity and efficacy of this treatment~     technique.~   "
111296|NCT02110706|"~     The specific primary objective of this study is to determine whether rituximab is a safe and~     beneficial therapeutic for Myasthenia Gravis (MG) that warrants further study in a phase III~     efficacy trial.~   "
111297|NCT02110693|"~     The purpose of the study is to develop and validate a questionnaire to screen and assess~     adult primary care patients for tobacco, alcohol, prescription drug, and drug use and~     problems related to their use.~   "
111286|NCT02110836|"~     Carbohydrate is stored in the body as glycogen, which is mainly found in the liver and~     muscle. During endurance exercise, muscle glycogen is used as fuel for the working muscles~     and liver glycogen is broken down to provide glucose to maintain blood glucose (sugar)~     levels. Both liver and muscle glycogen are important for the ability to perform~     intense/prolonged endurance exercise. Therefore, nutritional strategies which can maximise~     the availability of glycogen in muscle and liver can benefit endurance exercise capacity.~      The carbohydrates typically found in sports drinks are glucose and sometimes fructose. If~     glucose only is ingested during exercise, then the maximum rate at which can be absorbed from~     the intestine into the blood stream is ~1 g/min. However, if different sources of~     carbohydrate (fructose) are used, which are absorbed through a different pathway, absorption~     of carbohydrate can be up to ~1.8 g/min. With more carbohydrate available as a fuel, this~     translates into an improvement in performance.~      Sucrose is a naturally occurring sugar that is made up of a single glucose and single~     fructose molecule. Therefore, theoretically, this can use the two different pathways of~     absorption and also maximise carbohydrate delivery. It is not yet known however, what impact~     this has on our liver and muscle glycogen stores during exercise. Therefore the aim of this~     study is to assess whether sucrose ingestion influences liver and muscle glycogen depletion~     during endurance exercise.~   "
111287|NCT02110823|"~     The Single Ventricle Reconstruction (SVR) Trial looked at how infants with single ventricle~     heart defects did after the first stage of surgery (Norwood operation). Infants enrolled in~     the trial got one of two kinds of shunts during the Norwood; a modified Blalock-Taussig shunt~     (MBTS) or right ventricle to pulmonary artery shunt (RV-to-PA shunt).~      The purpose of this study is to learn if children (2-6 years of age) who were enrolled in the~     SVR Trial do better with one of the two shunts (MBTS or RV-to-PA) in the years after surgery.~   "
111288|NCT02110810|"~     Endoscopic retrograde cholangiopancreatography (ERCP) is now a widely accepted therapy for~     treating benign and malignant diseases of the pancreatobiliary tree. Acute pancreatitis~     represents the most common and feared complication following ERCP. The reported incidence of~     this complication is from 1% to 40% according to the presence of high-risk factors for this~     complication or the presence dysfunction in the sphincter of Oddi (SOD). In most prospective~     series, the incidence has ranged between 3.5% and 20% for nonselected and high-risk patients,~     respectively. Independent risk factors for post-ERCP pancreatitis are either patient- or~     procedure-related.~   "
111289|NCT02110797|"~     Based on our clinical observations, many girls with RETT syndrome, a severe~     neuro-developmental encephalopathy, suffer from osteoporosis which can appear at a very early~     age (before age 10) and can lead to fractures, pain and a limitation in mobility. Few~     epidemiological studies have estimated the frequency of osteoporosis in girls with RETT~     syndrome and showed that they are more exposed then children with other neuro-developmental~     diseases with a same degree of neurological handicap. However, the mechanisms that lead to~     early osteoporosis in RETT syndrome remain unknown. Mutations in the MECP2 gene are found in~     95% of RETT patients and preliminary experimental studies have shown that this can lead to~     abnormal expression of the gene that codes for osteoprotegerin, a protein implicated in bone~     remodelling by interacting with RANK-ligand.~      In order to identify risk factors of osteoporosis in RETT syndrome and to understand the~     pathophysiological mechanisms the study protocol includes:~        1. Clinical evaluation of bone health (history of bone fractures, pain, nutritional status,~          pubertal stage, daily caloric/calcium intake, anti-epileptic drugs, walking ability,~          vitamin D satus)~        2. evaluation of the mineral density at the lumber spine using DEXA~        3. measuring concentrations of osteoprotegerin and RANK-ligand~   "
111290|NCT02110784|"~     The aim of the present study is to investigate the efficacy, safety and tolerability of a~     therapeutic course of Eurartesim® in travellers who contracted malaria due to infection by P.~     vivax in endemic countries.~   "
111291|NCT02110771|"~     Social cognition impairments was highlighted for persons suffering with schizophrenia by~     numerous studies. The use of treatment programs intended to treat specifically these deficits~     through procedures of cognitive remediation, will allow decreasing their impact on everyday~     life by improving abilities to understand and interact with others. Such tools could allow~     also profits in terms of reduction of positive and negative of schizophrenia. The Gaïa~     program is intended to improve the perception of the facial affects which is one of social~     cognition processes impaired in schizophrenia.~      Methods:~      This is a multicenter, randomized, controlled study comparing people aged 18 to 45 years with~     a diagnostic of schizophrenia according to the Diagnostic and Statistical manuel of Mental~     disorders, 4th edition (DSM-IV-TR).~      The GAÏA program will be compared to an already validated neurocognitive remediation program,~     training attentional processes (RECOS).~      100 patients will be randomized as follows: Arm 1, experimental: Gaïa (20h with therapist,~     computer assisted method) Arm 2, control: RECOS (20h with therapist, computer assisted~     method)~      Condition: Schizophrenia Intervention: Behavioural: computer assisted cognitive remediation~      Hypothesis:~      A targeted cognitive remediation will more increased abilities in facial affects recognition~     processes than a non specific, attentional cognitive remediation.~      Primary outcome measures:~      - Change from baseline in performances in the Facial Emotion Recognition Task (TREF) after 10~     weeks and 20 session of treatment.~      Secondary outcome measures~        -  Change from baseline in clinical, psychosocial, social cognition and neurocognitive~          measures, after 10 weeks and 20 session of treatment and at 6 months follow-up.~        -  Change from baseline in performances in the Facial Emotion Recognition Task (TREF) after~          treatment and 6 months follow-up.~   "
111292|NCT02110758|"~     The National Committee for Quality Assurance has worked with the National Coalition for~     Cancer Survivorship, the American Society of Clinical Oncology, Oncology Management Services,~     Independence Blue Cross, and RAND, as well as a broader multi-stakeholder advisory group, to~     define the Patient-Centered Oncology Care model. The purpose of this project is to pilot and~     evaluate this model. Specific research questions are:~        1. Does Patient-Centered Oncology Care improve patient experiences and quality of care?~          Does it reduce undesirable events like emergency department visits and hospital stays?~        2. How does adoption of Patient-Centered Oncology Care vary across a variety of practices~          and what factors affect adoption?~      The demonstration will take place in oncology practices in southeastern Pennsylvania.~     Practices will receive implementation support during the 24-month demonstration period. They~     will be evaluated using patient surveys, quality measures, and measures of emergency~     department and hospital use. Results from these practices will be compared in two ways: 1)~     with their performance before they became oncology medical homes and 2) with other similar~     practices.~   "
111293|NCT02110745|"~     The objective of this study was to determine (a) whether patients anesthetized with~     intravenous propofol have less pain compared with sevofluorane for paediatric inguinal hernia~     and undescended testis operations and (b) whether intravenous propofol anesthesia has better~     quality of recovery compared with sevofluorane anesthesia in the immediate postoperative~     period after paediatric inguinal hernia and undescended testis operations.~   "
111298|NCT02110680|"~     Overactive bladder (OAB) is a very common problem that impairs the quality of life of about~     17% of adult population in USA above the age of 40. The issues becomes more prominent with~     getting older. OAB was determined by International Continence Society as urgency (immediate~     desire to urinate that could not be postponed) with or without incontinence usually~     associated with increased frequency and nocturia (urination at night). In 2012, American~     Urologic Association published clinical guidelines for the treatment of OAB of non neurogenic~     origin. Neuromodulation was proposed as the third line of treatment and two treatments were~     recommended: sacral nerve neuromodulation (SNM) and posterior tibial nerve stimulation~     (PTNS). Each of above mentioned procedures are invasive. SNM involves lead implantation in~     operating room using X-ray guidance and anesthesia. PTNS involves needle insertion on the low~     extremity.~      The investigators would like to examine the efficacy of transcutaneous nerve stimulation~     (TENS) in refractory to the first two lines of OAB treatment patients.~   "
111299|NCT02110667|"~     This study is being done to find out if transperineal ultrasound (TPUS) can help define the~     prostate bed for radiation treatment planning and improve upon current methods of image~     guidance for the treatment of prostate cancer. For the patient, TPUS involves the placement~     of an ultrasound probe on the perineum, the skin between the scrotum and anus, while they are~     lying on their back in the position they will receive their treatment. Image-guidance is~     required for the treatment of prostate cancer because the prostate bed shifts position~     depending on how full the bladder and rectum are. Image-guided radiation therapy has been~     done at Fletcher Allen Health Care for approximately three years. Most commonly,~     transabdominal ultrasound images are obtained every day and compared to an ultrasound that~     was done on the day of treatment planning. Adjustments in radiation field position can be~     done on a daily basis by comparing these images. Transperineal ultrasound has never been used~     for image-guidance. We completed two phases of an earlier study and have developed a TPUS~     device and process that allow us to get clear ultrasound pictures of the prostate gland, and~     now we would like to explore imaging the prostate bed left after radical prostatectomy.The~     TPUS has three potential advantages over the transabdominal method we currently use:~        1. Transabdominal ultrasound can be a challenge for some men. A full bladder helps us get~          clearer images, however it is difficult for some men with prostate cancer to comfortably~          keep a full bladder. It is also particularly difficult to get good images in larger men~          who have long distances from the skin surface to the prostate bed. TPUS is not dependent~          on a man having a full bladder and should be less dependent on the size of the man.~        2. TPUS images and the planning CT images can be acquired simultaneously. This is not~          possible with the abdominal probe because it gets in the way of the CT machine.~          Simultaneous imaging eliminates the possibility of the prostate bed shifting positions~          during the time between imaging studies.~        3. TPUS can be in place and acquire images during patient treatment (the abdominal probe~          gets in the way of the treatment machine) and may in the future allow us to watch the~          prostate bed during treatment. If we discover that we can accurately view the prostate~          bed in real time, TPUS may ultimately allow us to treat even smaller radiation fields~          and possibly decrease the risk of radiation complications.~      Patients in this study will be treated for their prostate cancer with the standard image~     guidance technique used at Fletcher Allen Health Care: transabdominal ultrasound. In~     addition, one TPUS scan will be acquired at the time of the initial simulation.~      To summarize, the two objectives of this study are:~        1. To determine if TPUS can acquire usable, clinically pertinent IGRT images of the~          prostate bed.~        2. To preliminarily compare TPUS images of the prostate bed to images obtained with CT and~          TAUS.~   "
111300|NCT02110654|"~     1. objectives. To compare the efficacy and the safety of mometasone furoate nasal spray~          (MFNS; Nasonex 200μg, daily) alone versus a combination with montelukast (singulair~          10mg, daily) in chronic rhinosinusitis (CRS) with asthma after functional endoscopic~          sinus surgery (FESS) for improvement the clinical control of CRS~        2. the clinical hypotheses. The investigators hypothesize that postoperative combined~          montelukast and MFNS can better improve clinical control of CRS concomitant with asthma~          after FESS compared with MFNS alone.~        3. study design This study is a 9-month randomized, open-label, controlled interventional~          study.~   "
111301|NCT02110641|"~     The specific aims of this study are to determine the efficacy and cost-effectiveness of a~     weight loss program compared with usual care (control) treatment on 6-month changes in body~     weight, body fat, serum hormones, and breast tissue markers associated with prognosis in~     breast cancer survivors.~   "
111302|NCT02110628|"~     Gastric is one of the most prevalence digestive malignance tumors in China. Radical resection~     of primary tumors and combine with dissection of regional lymph-nodes is acknowledged by~     surgeons all over the world. Nowadays, in order to improve the quality of life, controversies~     still exist to the reconstruction methods of total gastrectomy. Although roux-en-y~     anastomosis is the most common method adopted after total gastrectomy for it is an easily and~     safety method reconstruction method, but some problems still need us to solve, such as little~     food reserves, less food intake per meal and fast gastric emptying. These problems~     significantly affect the patients' quality of life after surgery. Roux-en-Y+Jejunal pouch~     anastomosis is newly born method can significant increase the volume to improve postoperative~     quality of life have been proven by some little sample size randomized control trail With the~     improvement of the gastric cancer surgery, this study proposed by prospective randomized~     controlled clinical trials aimed to comparing quality of life after traditional Roux-en-Y~     type and Roux-en-Y+ Jejunal pouch type anastomosis for radical total gastrectomy. Quality of~     life was evaluated according to the European Organization for Research and Treatment of~     Cancer (EORTC) Quality Of Life Questionnaire (QLQ)-C30 and QLQ-STO22. Quality of life will~     conducted in the 3 months, 6 months, 9 months, 12 months, 24 months, 36 months after~     gastrectomy.~   "
111303|NCT02110615|"~     Mass in Motion Kids is a whole-of-community intervention in Fitchburg and New Bedford,~     Massachusetts that incorporates evidence-based interventions across multiple sectors and at~     multiple levels. The overall goal of the study is to examine the extent to which the~     comprehensive, systematic intervention reduces childhood obesity among underserved children.~      The clinical intervention implements evidence-based interventions each city's~     federally-qualified community health center. Intervention components aim to improve primary~     and secondary prevention of childhood obesity and implement changes at four levels:~     clinician; parent-family; organizational; and environmental. We additionally provide training~     and educational materials to other pediatric clinicians in the two communities. The clinical~     intervention components include (1) advanced training on clinical quality improvement and~     obesity prevention, assessment, management; (2) computerized, point-of-care decision support~     tools for clinicians; (3) implementation of multi-disciplinary weight management programs~     within the community health centers, e.g. Healthy Weight Clinics (HWC); (4) integrating~     community health workers into the primary care and HWC teams; and (5) health center~     environmental changes to support behavior change modification.~   "
111304|NCT02110602|"~     The investigators are conducting this research study to find out if eating low or high levels~     of specific amino acids changes the levels of these same amino acids in the blood. Amino~     acids are the building blocks of protein that are normally found in food. The amino acids the~     investigators are studying are called branched chain amino acids. The investigators will look~     at the levels (amount) of branched chain amino acids in blood before and after consumption of~     specially prepared meals. The investigators hypothesize that circulating branch chain amino~     acid (BCAA) levels will be lower following a low BCAA-content diet compared with a high~     BCAA-content diet.~   "
111305|NCT02110589|"~     Epilepsy is an episodic disorder which can result in recurrent seizures often associated with~     hypertonia (muscle stiffening) and myoclonia (involuntary muscle jerking). Hypertonia can~     often occur before full expression of the seizure and so detection of hypertonia could act as~     an alarm to epilepsy patients and carers in order to prepare for a seizure event. Secondly, a~     recording device for seizure frequency and duration is a valuable clinical tool for~     collecting data for clinicians who manage the disorder in primary and tertiary care. The~     investigators have developed a portable prototype for hypertonia detection using a~     non-invasive, muscle activated, sensor that records seizure activity. The investigators now~     want to test this sensor system in patients identified by Consultant Clinician Custodians~     within the Wales Epilepsy Research Network (WERN). The Epidetect® prototype has been~     developed by VIKEL LTD™ in collaboration with WERN - a Welsh Assembly funded network.~   "
111306|NCT02110576|"~     CLSI guidelines shall be followed to gather data from a minimum of one hundred and twenty~     normal donors to create reference intervals for various Haemonetics reagents. Venous blood~     from a minimum of 146 reference subjects shall be tested. Blood from 160 donors will be drawn~     at the study site to account for aberrant or outlying data excluded for technical or other~     reasons.~   "
111307|NCT02110563|"~     The purpose of this study is to assess the safety and tolerability of the investigational~     anticancer drug DCR-MYC. DCR-MYC is a novel synthetic double-stranded RNA in a stable lipid~     particle suspension that targets the oncogene MYC. MYC oncogene activation is important to~     the growth of many hematologic and solid tumor malignancies. In this study the Sponsor~     proposes to study DCR-MYC and its ability to inhibit MYC and thereby inhibit cancer cell~     growth.~   "
111308|NCT02110550|"~     Background: no randomized controlled trial has tried to compare treatment outcomes between~     the IPS.emmax endocrowns and the IPS.emmax conventional crowns .~      Objective: to investigate the clinical performance of the IPS.emmax endocrowns and the~     IPS.emmax conventional crowns Design and setting: Parallel-groups randomized controlled trial~     on patients with one or more intensive damaged molars requiring crowning and being treated at~     the University of Damascus, Dental School in Damascus, Syria .All molars will be examined at~     the baseline assessment using a modified US Public Health Service (USPHS) criteria.~      Participants: Incoming patients to the Fixed Prosthetic and Endodontic Departments will be~     examined to find any excessively damaged molars requiring crowning. Forty patients will be~     recruited according to specific inclusion criteria. Randomization will be performed using~     computer-generated tables; allocation will be concealed using sequentially numbered opaque~     and sealed envelopes.The included 40 patients will be analyzed (age range between 20-60~     years). They will be randomly distributed into two groups with 20 patients in each group (1:1~     allocation ratio).~      Intervention: Excessively damaged and endodontically treated molars will be restored with~     IPS.emmax endocrowns or IPS.emmax crowns supported with composite core.~      Main outcome measure: marginal adaptation and anatomic form will be investigated clinically~     and by apical radiographs at the baseline assessment using the modified (USPHS) at six~     assessment times during an 18-month observation period.~      Assessor blinding will be employed.~   "
111309|NCT02110537|"~     The aim of this trial is to evaluate the effect of acupuncture on prevention of atrial~     fibrillation (AF) recurrence after electrical cardioversion (EC) for persistent AF patients~     resistant to the antiarrhythmic drugs (AADs).~   "
111310|NCT02110524|"~     The purpose of this study is to assess safety and the inhibition of restenosis of the CVI~     Paclitaxel-coated PTA Balloon Catheter in the treatment of de-novo occluded/stenotic or~     reoccluded/restenotic superficial femoral (SFA) or popliteal arteries.~      The primary endpoint for this analysis is late lumen loss at six (6) months.~   "
111311|NCT02110511|"~     The aim of this study is to determine the effects of bean physical form (whole versus~     blended) and Beano on postprandial responses. The postprandial responses the investigators~     will examine include blood glucose, appetite, metabolic rate, physical symptoms, and mood. To~     accomplish this aim the investigators will conduct a randomized, placebo-controlled trial in~     overweight and obese but otherwise healthy (non-diabetic) men and women~   "
111312|NCT02110498|"~     This research is being done to learn more about pancreatic cysts. The tests that are~     currently available are imperfect at determining exactly what type of pancreatic cyst a~     person has, which cysts contain cancer, or what the risk is of developing cancer in the~     future. The aim of this study is to use a combination of clinical, imaging, cyst fluid~     analysis, and molecular markers to try to help develop better tools to answer these~     questions.~   "
111313|NCT02110485|"~     The purpose of this study is to determine if a patient activation tool (PAT) can improve~     decision making and patient centered outcomes in pediatric patients with appendicitis and~     their caregivers choosing between antibiotics alone and appendectomy.~   "
111314|NCT02110472|"~     The Presbia Flexivue Microlens is a corneal inlay.~   "
111315|NCT02110459|"~     To investigate the pharmacokinetics (PK) of POL7080 in subjects with renal function~     impairment after single intravenous (IV) infusion of POL7080~   "
111316|NCT02110446|"~     To evaluate the efficacy of Chinese herbal medicine (SS-1) for the Sjögren's syndrome (SJS)~     patients.~   "
111317|NCT02110433|"~     Heart failure is a serious and common disease. HF is marked by a high rate of preventable~     hospitalizations through proper care. As such, it is a key target for telemedicine programs.~     However, currently published data are inconclusive. Investigators propose a multicenter~     randomized study of innovative telemedicine involving the usual patient monitoring daily~     weight monitoring, clinical signs and in one of three groups in our study of BNP testing in~     the patient's home all associated with a regular education reinforcement. The objective is to~     identify early cardiac decompensation to allow to treat ambulatory and thus prevent the~     occurrence of more serious events such as death or rehospitalization.~   "
111318|NCT02110420|"~     First-in-human study to evaluate safety, tolerability, and pharmacokinetics of single and~     multiple ascending doses of CC-90001~   "
111319|NCT02110407|"~     The aim of this study is to investigate whether a combination of intensive training of~     visual-spatial abilities (LOCATO task) with anodal transcranial direct current stimulation~     (tDCS) leads to an improvement of learning and memory in healthy young adults and to examine~     the underlying neuronal mechanism.~   "
111320|NCT02110394|"~     Prospective multicenter observational non-interventional study to assess routine clinical~     practice of Bendamustine use in the first line therapy of chronic lymphocytic leukemia~   "
111321|NCT02110381|"~     An estimated 76 million adults in the United States over the age of 20 have hypertension~     (HTN); which translates into 1 out of 3 adults. Globally the prevalence of HTN is over 25%~     for adults, and accounts for approximately 13.5% of all deaths. Given the aging of the~     population together with increases in obesity and sedentary behavior, it is not surprising~     that HTN is projected to increase significantly over the next several decades; with over 1.5~     billion adults having HTN by the year 2025. Thus the public health implications to preventing~     and/or reducing elevations in blood pressure are substantial.~      This study compares the efficacy of two different non-pharmacologic interventions (device~     guided breathing and isometric hand grip exercises) used alone and in combination for~     lowering blood pressure. This pilot study will include 30 adults with stage 1 hypertension.~     The primary outcome is the change in blood pressure from baseline to 8 weeks. Secondary~     outcomes include change in blood pressure from 8 weeks to 16 weeks and acceptability of the~     interventions by participants. The knowledge gained from this study can provide information~     on non-pharmacologic methods that may be useful in decreasing blood pressure. Such knowledge~     may be especially useful for patients for whom access to medications and health care is~     limited and among patients unwilling to take or intolerant to pharmacologic therapies.~   "
111322|NCT02110368|"~     Bioequivalence study comparing the rate and extent of testosterone absorption for a test~     formulation versus the reference product.~   "
111323|NCT02110355|"~     Phase 1b/2a, open-label, sequential dose escalation and expansion study of AMG 232 in~     combination with trametinib and dabrafenib in subjects with metastatic melanoma followed by a~     direct comparison of AMG 232 combined with trametinib and dabrafenib versus trametinib~     combined with dabrafenib alone.~   "
111324|NCT02110342|"~     The study aims to understand, using radiolabelled PF-04449913, how this compound is modified~     by the body once it is absorbed. The study also aims to understand how much of the compound~     is broken down and how much leaves the body unchanged.~   "
111325|NCT02110329|"~     Lymph node involvement remains the main criteria for postoperative chemotherapy in patients~     with colon cancer (CC) without distant metastasis. To date, the prognostic value of the~     somatic quantitative molecular alterations such as loss or gain of genomic region is not~     established in CC.~      AIMS & METHODS: Using the one-step screening method based on the Quantitative Multiplex PCR~     of Short fluorescent Fragments (QMPSF), we aimed to assess the prognostic role of the~     simultaneous detection of main quantitative somatic alterations in stage II-III CC.~      Patients and Methods. We enrolled and collected all baseline characteristics of patients~     operated for a stage II-III CC with storage frozen tissues. The QMPSF was based on a~     simultaneous amplification of 9 selected target genomic sequences from literature: DCC~     (18q21); EGFR (7p12); P53 (17p13.1); BLK (8p23-p22); c-myc (8q24.12); APC (5q22.2); ERBB2~     (17q12); STK6 (20q13.31); NR21 (14p11.1) and two control: DCOHM (5q31.1); HMBS (11q23.3).~     Comparison of each amplicon electropherograms obtained from tumour vs normal peritumoral~     tissue allowed us to identified gain or loss genomic region. The primary end-point was the~     local and/or distant recurrence and relation between clinical and single or combined~     molecular alterations and recurrence were evaluated.~   "
111326|NCT02110316|"~     The objective of this study is to obtain the absolute bioavailability of voriconazole in~     critically ill ICU patients, because pharmacokinetics can be different in critically ill~     patients due to alterations in function of various organs and body systems compared with~     healthy volunteers.~   "
111327|NCT02110303|"~     Heart attacks are most commonly caused by rupture of fatty deposits (plaques) within the wall~     of heart blood vessels. It appears that this process can also frequently occur without~     causing any symptoms and these events likely explain the development of narrowing within the~     heart arteries which can subsequently produce symptoms of angina (chest pain).~      Previous research has shown a specialised scanner known as a PET (positron emission~     tomography) scan can identify these recently ruptured plaques in patients without symptoms of~     a heart attack and these patients have changes on a blood test (troponin) which suggest that~     they are at higher risk of having a heart attack in the future. This study aims to identify~     these patients using the PET scan and then see if the markers of increased heart attack risk~     can be reduced by the use of a blood thinning medication (ticagrelor) which is already a well~     recognised treatment for people who have suffered a recent heart attack.~   "
111328|NCT02110290|"~     This study is assessing quality of life in children with a physical disability who~     participate in the Children's Hospital Colorado Hospital Sports Program (HSP), where children~     with physical disabilities are able to participate in more organized sports and active~     programs with the use of adaptive equipment. This study would assess a child's self reported~     and parent perceived quality of life before and after child participation in HSP for the~     winter season. The investigators aim to determine the level of child and parent happiness and~     satisfaction in specific quality of life aspects including: physical activities and health,~     feelings, moods, self perception, home life, friends, school, learning and bullying. The~     investigators believe that children with any physical disability will have a more~     satisfactory reported quality of life after participating in HSP for one or many years.~   "
111329|NCT02110277|"~     The purpose of this study is to develop technology to image the ovaries in order to better~     evaluate ovarian disease and to study how these experimental imaging techniques might work~     together or separately to improve our ability to detect ovarian cancer.~   "
111330|NCT02110264|"~     The aim of this trial is to assess the clinical utility, effectiveness, and cost implications~     of treatment for incarcerated offenders with opioid use disorders who are randomly assigned~     to one of three treatment conditions to include a depot formulation of naltrexone (XR-NTX, as~     Vivitrol®) only (XR-NTX), Vivitrol provided with sessions with a patient navigator (PN)~     XR-NTX+PN, and a drug education procedure (ETAU) before being released to the community. This~     trial will investigate whether effective medication therapy used in non-incarcerated~     populations will also be effective in incarcerated individuals. Empirical evidence~     demonstrates that starting treatment before release greatly increases the probability of~     successful outcome including reduced alcohol and drug use, increased employment rates, and~     reduced recidivism rates.~   "
111345|NCT02110043|"~     The aim of this study is to investigate whether a combination of intensive training of~     visual-spatial abilities (LOCATO task) with anodal transcranial direct current stimulation~     (tDCS) leads to an improvement in learning and memory in patients with mild cognitive~     impairment (MCI) and to examine the underlying neuronal mechanism.~   "
111331|NCT02110251|"~     Patients with peripheral arterial disease with symptoms of critical ischemia or reduced~     tissue loss have a very high mortality and morbidity rate. So far, treatment strategies~     focused on the preservation of life and limb by an open surgical or endovascular~     revascularization, together with cardiovascular risk management and pain relief. Important~     modifiable factors related to mortality and morbidity are not covered in the current national~     and international guidelines. This study investigates the effects on mobility, mortality and~     quality of life with supplementation of the standard treatment of critical limb ischemia with~     supervised exercise therapy. Also a reduction of cardiovascular risk by intensive risk factor~     management and lifestyle coaching will be taken in to account. The supervised exercise~     therapy will take place under the supervision of a trained physiotherapist.~   "
111332|NCT02110238|"~     The purpose of this study is to demonstrate non-inferiority of three weekly intra-articular~     injections of SUPARTZ to three weekly intra-articular injections of Euflexxa for the relief~     of knee OA.~   "
111333|NCT02110225|"~     The primary objective of the study is to assess the safety and tolerability of two dose~     regimens of recombinant human nerve growth factor (rhNGF) eye drops solution administered~     over 6 months versus a vehicle control in patients with typical retinitis pigmentosa. The~     secondary objective of this study is to attempt to show a dose response by assessing the~     potential efficacy of the rhNGF dose regimens for improving or slowing the deterioration of~     visual function outcomes at 3 and 6 months. During a 6 month follow-up period patients will~     be monitored to determine if there is evidence of a persistent biological effect after~     discontinuation of the study treatment.~   "
111334|NCT02110212|"~     The objective of this study is to evaluate the safety and efficacy the OptiMedica Femtosecond~     Laser System, also known as the Catalys™ Precision Laser System, to perform two surgical~     maneuvers used in the treatment of subjects with cataracts. Efficacy will be evaluated by~     comparisons to the standard surgical procedure of continuous curvilinear capsulorhexis (CCC)~     and ultrasonic phacoemulsification.~   "
111335|NCT02110186|"~     The purpose of this study is to compare safety and outcomes of the following treatments of~     lumbar disc herniation: (1) discectomy with posterior dynamic stabilization with those of (2)~     discectomy alone or (3) discectomy with internal fixation and fusion.~      Discectomy with posterior dynamic stabilization is proposed as the most effective treatment~     to improve range of motion, and to be similarly effective to discectomy alone and discectomy~     with internal fixation and fusion for other functional outcomes after surgery.~   "
111336|NCT02110160|"~     The purpose of this study is to assess the utility of FDG PET/CT in evaluating response of~     bone dominant breast cancer to therapy. Eligible patients with bone dominant ER+ breast~     cancer will undergo baseline FDG PET/CT for evaluation of their disease, after the start of~     therapy they will undergo an FDG PET/CT scan at 4 weeks and again at 12 weeks. PET/CT results~     will be compared to clinical measures of response, time to progression and overall survival.~   "
111337|NCT02110147|"~     This protocol has two parts - the Main Study which is 42 days in length and the Treatment~     Extension which allows the patients who complete the Main Study to continue receiving~     treatment with uridine triacetate. The purpose of this study is to replace oral~     administration of uridine with oral administration of uridine triacetate in patients with~     hereditary orotic aciduria who have received (or would reasonably be expected to receive)~     clinical benefit from treatment with exogenous uridine. It is also to document the continued~     clinical benefit of exogenous uridine when patients are switched from oral administration of~     uridine to oral administration of uridine triacetate.~   "
111338|NCT02110134|"~     The purpose of this study is to compare a hydroquinone skin care regimen alone to a~     combination of Revlite Laser treatment with a hydroquinone skin care regimen for the~     treatment of melasma.~   "
111339|NCT02110121|"~     The purpose of this study is to evaluate the Picosure and Revlite Laser Systems for the~     treatment of unwanted tattoos.~   "
111340|NCT02110108|"~     The purpose of this study is to evaluate the effects of the Revlite Laser System for~     treatment of facial solar lentigines~   "
111341|NCT02110095|"~     The purpose of this study is to evaluate the Picosure Laser System for the treatment of~     unwanted tattoos.~   "
111342|NCT02110082|"~     The purpose of the study is to determine the safety, tolerability and maximum tolerated dose~     of Urelumab in combination with Cetuximab in patients with Advanced/Metastatic Colorectal~     Cancer or Advanced/Metastatic Squamous Cell Carcinoma of the Head and Neck.~   "
111343|NCT02110069|"~     In this research study we want to learn more about which treatment works better for patients~     diagnosed with a vascular tumor called Kaposiform Hemangioendothelioma (KHE) or other high~     risk vascular tumors such as Tufted Angioma (TA). In these tumors, the blood cells that help~     your blood clot called platelets become trapped in the tumor causing swelling, pain, and~     bruising. Vascular tumors can be life threatening. There are few medical treatments that will~     work to shrink the vascular tumor. Some doctors will use steroids and vincristine to try and~     shrink vascular tumors.~      In this research study, the study doctor will compare two different drugs to see which one~     will work better to help shrink your vascular tumor. One of the drugs is vincristine.~     Vincristine is approved by the Food and Drug Administration (FDA) to treat people with~     cancer. Vincristine is used to stop the abnormal cells from growing such as cells that make~     up blood vessels.~      The other drug to be used in this study is sirolimus. Sirolimus is currently approved by the~     Food and Drug Administration (FDA) to prevent transplanted organ rejection. Sirolimus is not~     approved by the FDA for treatment of vascular abnormalities and is considered experimental.~     Sirolimus belongs to a class of drugs call 'mTOR inhibitors'. mTOR (mammilian target of~     rapamycin) helps cells to grow and may also help blood vessels to grow in a more normal~     fashion. Sirolimus is currently being tested in patients with vascular tumors and cancer. In~     vascular tumors, we hope sirolimus will stop the blood vessel growth.~      Funding Source: FDA - OOPD (Office of Orphan Products Development)~   "
111344|NCT02110056|"~     The aim of this study is to investigate whether a combination of intensive training of~     visual-spatial abilities (LOCATO task) with anodal transcranial direct current stimulation~     (tDCS) leads to an improvement of learning and memory in healthy older adults and to examine~     the underlying neuronal mechanism.~   "
113679|NCT02079467|"~     The purpose of this study is to determine whether the form of rehabilitation following~     primary total hip arthroplasty has an influence on patient satisfaction or functional~     performance in the eighteen weeks following surgery.~   "
111346|NCT02110030|"~     Objective: The investigators aimed to compare the effectiveness of transcutaneous electrical~     nerve stimulation (TENS) and interferential currents (IC) to improve shoulder functionality~     and to reduce perceived pain in patients with subacromial impingement syndrome (SIS). Design:~     Thirty-six patients with unilateral shoulder pain and diagnosed as having SIS were randomly~     assigned into two groups: TENS (n=18; 51±7 years) and IC (n=18; 47±6 years). Patients in both~     groups received fifteen 30-min sessions of the assigned treatment for a period of 3 weeks.~     Before and after the treatment, shoulder pain was measured using a 100-mm visual analog scale~     and shoulder functionality was measured using the Constant-Murley scale.~   "
111347|NCT02110017|"~     An impairment in social cognition in schizophrenia could account for the severe professional~     and social difficulties among patients. Social cognition is the way the social world is~     understood, perceived and interpreted. It includes all the process than enable oneself to~     interact with another person, namely emotion perception and processing, theory of mind (ToM),~     social perception, social knowledge and attributional style. Since these process are~     interconnected, social cognition should be investigated through ecological tasks which~     activate all of them together. Developing a social cognition ecological task, then testing~     the reproducibility of the functional magnetic resonance imagery (fMRI) BOLD signal is the~     main objective of this study. The secondary objective is to seek a functional deficit among~     the neural network of social cognition in patients with schizophrenia compared with healthy~     subjects.~      Forty healthy subjects, aged from 18 to 60 years old, who have given a written consent, will~     be included. The social cognition paradigm will be developed and the fMRI activations will be~     compared to those of a visual cartoon based task, known to turn on the neural network of ToM.~     BOLD signal variations at a high statistical correction ratio (p<0.05) will be explored and~     compared to the signal of a second fMRI, made on the same 20 healthy subjects one month~     later, to test reproducibility (% of identical activated voxels during the 2 fMRI, p<0.05).~      Twenty matched patients with schizophrenia (DSM-IV-R), aged from 18 to 60 will be included to~     test the secondary objective. We make the hypothesis of a fMRI functional alteration in the~     cerebral network involved in social cognition, especially in the medial prefrontal cortex,~     among patients compared with healthy subjects.~   "
111348|NCT02110004|"~     The primary purpose of the First-In-Man clinical investigation is to assess the Picasso NAV~     Catheter's ability to collect intracardiac signals within the desired chambers (atrial and/or~     ventricle) in the heart for the analysis of complex arrhythmias.~   "
111349|NCT02109991|"~     The purpose of this study is to evaluate the CG-100 device, a single use, temporary~     intraluminal bypass device,intended to reduce contact of fecal content with an anastomotic~     site, following colorectal surgery (open or laparoscopic).~   "
111350|NCT02109978|"~     This study will examine extreme responders to second- and third-line Type 2 Diabetes (T2D)~     therapy using a retrospective approach and patients with slow or fast diabetes progression.~   "
111351|NCT02109965|"~     Despite early goal-directed maintenance of normal macrocirculation, the reduction of 60-day~     mortality of patients with severe sepsis and septic shock remained unsatisfied (56.9% to~     44.3%). One of the major causes of high mortality is microcirculatory dysfunction. Delayed~     diagnosis and treatment of microcirculatory dysfunction may cause tissue hypoperfusion and~     resulted in multiple organ dysfunction and death. Dexmedetomidine is a highly selective~     α2-adrenoreceptor agonist which exhibits sedative and analgesic effects. Recent studies~     suggest that dexmedetomidine also has anti-coagulation and anti-inflammatory effects, and it~     can reduce the mortality of endotoxemic rats and patients with severe sepsis. The~     investigators will conduct two animal studies and one clinical trial to investigate the~     effect of dexmedetomidine on microcirculatory dysfunction and organ injury in rat with~     endotoxemia and patients with severe sepsis and septic shock.~      Sixty patients with severe sepsis and septic shock will be enrolled and randomized to control~     group or dexmedetomidine group. In the control group, the patients will be treated according~     to the clinical practice guideline. If sedation is required, non-dexmedetomidine sedative~     agents will be used. In the dexmedetomidine group, the patients will be treated according to~     the clinical practice guideline, and they will also receive continuous infusion of~     dexmedetomidine (infusion rate ranged from 0.1 to 0.7 mcg/kg/h) for 24 hours as needed. The~     sublingual microcirculation, serum level of Endocan, NGAL(Neutrophil Gelatinase-Associated~     Lipocalin), and BNP(B-type natriuretic peptide) will be examined at preset time points up to~     24 hours. The vital signs, hemodynamic parameters, and survival of 28-day and 90-day will be~     recorded and analyzed.~   "
111352|NCT02109952|"~     The purpose of this study is to monitor fracture risk associated with bone tumors in cancer~     patients.~      Previous studies from our lab have suggested that it is possible to compute the mechanical~     strength of bones with tumors using computed tomography (CT) scans, which are like~     three-dimensional X-ray pictures of the affected bones.~      The next step in determining the usefulness of this type of strength analysis is to see if we~     can accurately predict who is at risk for bone fracture and which patients are at high risk~     of fractures.~      This non-invasive analysis may help physicians determine the best treatment to reduce the~     risk of an impending bone fracture in the future.~   "
111353|NCT02109939|"~     Evaluate the impact of GeneSight Psychotropic on response to psychotropic treatment as judged~     by the mean change in the 17-item Hamilton Depression (HAM-D17) score from baseline to end of~     Week 8 of the study.~   "
111364|NCT02109796|"~     Previous studies show that one session of tDCS allow to improve muscle strength in~     hemiparetic patients in anodal condition. We test a new electrods configuration : a anodale~     stimulation opposite to the cortical representation area of the injured hemisphere and a~     simultaneous stimulation opposite to the homonyme the cortical representation area of the~     healthy hemisphere. This approach seems to be the best relevant electrods configuration in~     order to restore the inter-hemispheric balance.~      We hypothesis that one session of tDCS with this electrods configuration allow to improve~     paretic quadriceps strength in hemiparetic patients after stroke.~   "
111399|NCT02109341|"~     At this moment, FOLFIRINOX is the best treatment for selected patients (pts) with metastatic~     pancreatic cancer (mPC). Investigator would like to evaluate the substitution of CPT11 or~     Oxaliplatin in FOLFIRINOX schedule with Nab-paclitaxel (Nab-p) [Nab-FOLFIRI and Nab-FOLFOX].~      Doses for Nab-FOLFIRI and Nab-FOLFOX will be determined by the phase I trial. One or both~     schedules will be evaluated in successive phase II part.~   "
111354|NCT02109926|"~     The incidence of testicular germ cell tumors, the most common cancer in men aged 15 to 45~     years, has doubled in France in 30 years. Reasons remain unclear but a role of environmental~     factors, especially during critical periods of development, is strongly suspected. Reliable~     data on environmental exposure during this critical period are sparse.The discordant findings~     and the limitations of available studies underline the importance to conduct studies with~     sufficient statistical power to detect risk due to exposures during critical windows of~     vulnerability.~      We conduct a multicentric case-control study to assess this association. Cases and controls~     will be enrolled during a 18-month period. They will be interviewed by professional telephone~     interviewers about their occupational and residential history and about their domestic~     exposure to pesticides and other nuisances.~      An optional biological study to assess genetic polymorphisms known to be associated with~     testicular cancer will be proposed to every cases and controls.~      Mothers (or close relative) of cases and controls will also be contacted (with son's~     agreement). If they agree to participate, they will also be interviewed about antenatal and~     early life exposure of their sons to pesticides and other nuisances.~      Cases will be matched up with 2 controls (one of each group) both on age (+/- 2 years) and on~     recruiting center.~   "
111355|NCT02109913|"~     The purpose of this study is to determine whether biomarkers could be found to gain more~     insight in tumor characteristics in order to predict which patients will have a high chance~     of a long progression-free survival. Postmenopausal patients with advanced metastatic breast~     cancer who have progressed on anastrozole or letrozole will be eligible for this study.~   "
111356|NCT02109900|"~     This observational study aims the potential role of serum progesterone levels on the day of~     oocyte pick-up on the probability of pregnancy, in patients undergoing antagonist IVF cycles.~      There has been evidence, that increased serum levels of progesterone on triggering day are~     associated with a decreased probability of pregnancy after IVF.~      There is no study that investigate assocation between serum progesterone levels on the day of~     oocyte pick-up and IVF outcomes. This study will be the first in this case.~   "
111357|NCT02109887|"~     PCP (Pneumocystis jiroveci pneumonia) is one of the important opportunistic infections in~     immunocompromised patients including HIV-infected patients, transplant recipients, and~     immunosuppressant users. About one third of non-HIV patients with PCP have the evidence of~     co-infection with CMV. In this difficult clinical situation, physicians have difficulty to~     decide on whether anti-CMV treament will help patients with any evidence of CMV co-infection.~     However, there is no objective test to differentiate true co-infection of CMV from innocent~     bystander of CMV in those with PCP. The investigators thus evaluate the usefulness of~     CMV-specific ELISPOT assay in patients with PCP to differentiate true co-infection of CMV~     from inocent bystander of CMV. This findings may guide physicians to decide anti-CMV~     treatment in patients with PCP and CMV co-infection.~   "
111358|NCT02109874|"~     This Phase I study will be conducted as a randomized, placebo-controlled, double-blind,~     dose-escalation study in four groups of healthy adult male and female subjects who are~     BCG-vaccinated, HIV-negative, and have no evidence of tuberculosis infection. The study will~     be conducted at one or two sites located in South Africa. The purpose is to evaluate the~     safety and immunogenicity of two injections of AERAS 404 prepared with four escalating~     amounts of antigen in healthy adult male and female subjects who are BCG-vaccinated,~     HIV-negative, and have no evidence of tuberculosis infection.~   "
111359|NCT02109861|"~     The purpose of the study is to identify specific genes that are up- or downregulated in~     multiple myeloma patients who receive a microdose of either Melphalan (Alkeran®), Bortezomib~     (Velcade®) or Dexamethasone (Dexaven®). The study treatment constitutes 1% of the planned~     standard myeloma treatment and will be given two hours prior to standard treatment. Blood~     samples are taken at baseline, 15, 30, 60 and 120 minutes for microarray analysis.~   "
111360|NCT02109848|"~     A prospective observational study on keratoconus and post-keratoplasty will be conducted. We~     will enroll 50 subjects in each of 3 groups: keratoconus, post-PK, and post-DSAEK. The~     Optovue anterior segment OCT prototype will be used to perform 3-D corneal scans. These scans~     will be used to measure corneal thickness (pachymetry), corneal topography (anterior and~     posterior) and epithelial thickness maps. The ultrahigh-speed MIT OCT prototypes will also be~     used when they become available. A comprehensive eye examination, Placido-ring corneal~     topography, ultrasound pachymetry, and Scheimpflug camera imagery, will be performed for~     comparison. In some post-PK and post-DSAEK cases, vision will be primarily affected by~     regular astigmatism, myopia, or hyperopia, rather than HOA. These cases can be corrected by~     standard PRK (not OCT guided) with adjunctive mitomycin C treatment to prevent haze~     formation.107, 108 In these cases PRK will be performed according to the standard of care and~     will not be a part of the study protocol. The postoperative results will be observed at the~     3-4 month visit with UCVA, manifest refraction, BSCVA, OCT scanning, Placido topography,~     ultrasound pachymetry, and Scheimpflug camera imagery~   "
111361|NCT02109835|"~     The purpose of the study is to identify a sub-group of diabetic patients at higher risk of~     progression of coronary disease and also more likely to suffer from heart attack/angina and~     heart failure. The total number of patients to be recruited in this study will be 250 with~     type-2 diabetes but no known heart disease. These patients will have an objective measure of~     the function of the lining of the arteries, CT scan of the arteries of the heart and an~     ultrasound scan of the heart and arteries of the neck done at baseline along with blood tests~     for identification new markers of malfunction of the lining and inflammation of the arteries.~     Patients will be followed up at 18 months. During the follow-up visit, in addition to the~     blood tests, the CT scan of the heart arteries and ultrasound of the heart and arteries of~     the neck will be repeated to assess progression of the non-calcified, calcified and mixed~     plaques in the coronary arteries.~   "
111362|NCT02109822|"~     The goal of this research study is to better understand current treatment practices for~     pulmonary exacerbations (lung infections) and whether the Cystic Fibrosis National Patient~     Registry (CFFNPR)can be used for this type of study.~   "
111363|NCT02109809|"~     This phase I trial studies the side effects and best dose of low-dose total lymphoid~     irradiation (LD-TLI) in treating patients with chronic graft-versus-host disease that has not~     responded to treatment with steroids. LD-TLI is a procedure in which all of the body's major~     lymph nodes are treated with small doses of radiation in order to reset the dysfunctional~     immune system. LD-TLI may work as a treatment for graft-versus-host disease caused by a bone~     marrow or stem cell transplant.~   "
111365|NCT02109783|"~     Numerous studies have investigated the effect of caffeine on athletic performance, but the~     findings have not been consistent. This is due, in part, to the differences in response that~     has been observed both within and between studies. Previous research in our lab has shown~     that genetic variations affecting caffeine metabolism modify the association between caffeine~     and heart disease. We hypothesize that the inconsistencies among studies relating caffeine~     and athletic performance may be due to genetic differences in caffeine metabolism or~     response. Male athletes will take part in an intervention of caffeine versus placebo, using a~     randomized double-blinded placebo-controlled design, which will test various exercise~     protocols (power, strength, anaerobic capacity, endurance) that are associated with~     performance across multiple sports. We will conduct a genome-wide association study, which is~     an approach that involves scanning for markers across the genomes of our study participants~     together, not individuals, to find genetic variations associated with a particular trait such~     as VO2 max, lactate clearance efficiency, muscle fiber type and changes in exercise~     performance following caffeine. We will also examine known genetic variations that are~     associated with caffeine metabolism and response, to determine if these genes also affect~     response to exercise after ingesting caffeine. Subjects will be paid $50.~   "
111366|NCT02109770|"~     The purpose of this study is to collect blood from families with a child who has been~     diagnosed with a chromosomal disorder including microdeletions in order to further develop a~     non-invasive prenatal screening test based on fetal DNA isolated from maternal blood.~   "
111367|NCT02109757|"~     The specific aim of this research is to evaluate the performance, effectiveness, and~     long-term training benefits of a formal hearing protection fit testing program. This study~     may provide preliminary evidence on the benefits of direct education/training combined with a~     formal hearing protection device (HPD) fit testing on HPD fittings on United States Air Force~     (USAF) employees. Currently, Public Health provides informal, subjective training to~     employees; this practice may be altered by the results of this study.~   "
111368|NCT02109744|"~     To evaluate the response to chemotherapy with the drug decitabine combined with rapamycin in~     the treatment of relapsed or refractory acute myeloid leukemia in patients of all ages, and~     in the treatment of newly diagnosed leukemia in those who are older than 65 when diagnosed.~   "
111369|NCT02109731|"~     The purpose of this study is to determine the effectiveness and feasibility of upper airway~     muscle physical therapy utilizing negative airway pressure (NAP) breathing training in~     patients with Obstructive Sleep Apnea Syndrome (OSAS) in reducing both signs (apnea hypopnea~     index) and symptoms (i.e., daytime sleepiness).The key to the proposed therapy is the use of~     Negative Air Pressure when awake so that the increased reflex phasic drive to the muscles~     will result in muscle conditioning. Interestingly, other studies have indicated that upper~     airway muscle training may be useful in treating OSAS, but these studies used techniques that~     were not scientifically designed{Puhan, 2006 8195 /id} or used a technique (electrical~     stimulation) that was not well tolerated.{Lequeux, 2005 7514 /id}~   "
111370|NCT02109718|"~     The Effectiveness of open dressing with petrolatum jelly in minor burns has not been clearly~     established. This study determined if the use of open dressings with petrolatum jelly as~     effective as standard gauze dressing with silver sulfadiazine in treating minor burns in~     terms of time-to-re-epithelialization, incidence of wound infection,incidence of adverse~     reactions, and patient acceptance.~      Non-extensive superficial partial thickness burns constitute a major proportion of burn~     injuries. Conventional treatment involves regular changing of absorptive dressings including~     the application of a topical antimicrobial, commonly silver sulfadiazine. A systematic review~     has found insufficient evidence to support or refute such antimicrobial prophylaxis. Another~     review compared silver sulfadiazine dressings with other occlusive and non-antimicrobial~     dressings and found insufficient evidence to guide practice. Other research has suggested~     that dressings with petrolatum gel are as effective as silver sulfadiazine. This trial sought~     to compare the effectiveness of conventional silver sulfadiazine dressings with treatment~     with petrolatum gel alone.~   "
111371|NCT02109705|"~     With this study the investigators would like to analyze the the role of periodontal disease~     and especially the role of Porphyromonas gingivalis in initiation and progression of~     Alzheimer`s Disease.~   "
111372|NCT02109692|"~     Duchenne muscular dystrophy (DMD) , caused by mutations in the DMD gene, is the most common~     and most severe progressive dystrophy of the child. Although the development is rapidly~     progressive , there is variability in the severity of the disease between DMD patients that~     do not correlate with the type of mutations in the DMD gene. There are no easily measurable~     biomarkers for monitoring the DMD or moderate form of the disease, Becker muscular dystrophy~     (BMD ) . MicroRNAs (miRNAs) are involved in most cellular processes , and their expression~     pattern is a signature of the state of a cell . They represent a potential class of~     diagnostic and prognostic biomarkers. Some are specific for the skeletal myogenesis , and~     changes in their pattern of expression are associated with muscle diseases including muscular~     dystrophy. The levels of muscle- specific miRNAs are indeed greatly increased in the serum of~     DMD and BMD compared to control patients .~      The main objective of this is to validate the use of serum muscle-derived microRNAs as~     biomarkers of DMD patients (compared with healthy subjects). Secondary objectives are i) to~     investigate the relationship between circulating levels of these miRNAs and the severity of~     the dystrophinopathy (DMD vs BMD) and also the progression of the disease (longitudinal~     study), ii) to assess the specificity of these markers for dystrophinopathy (comparison with~     other patients with muscular dystrophy), iii) to test candidate miRNAs recently identified~     but not yet analyzed in the serum of patients.~      Clinical data and samples will be recorded at each regular consultation. miRNA levels will be~     quantified using Real Time Quantitative RT-PCR.~   "
111373|NCT02109679|"~     To investigate bioavailability of BI 187004 and of metformin after concomitant multiple oral~     administration of 240 mg BI 187004 q.d. and 1000 mg metformin b.i.d. in comparison to BI~     187004 and metformin given alone.~   "
111374|NCT02109666|"~     The purpose of this study is to estimate the retention rate of Abatacept over 24 months in~     routine clinical practice in every participating country depending on the treatment line.~   "
111446|NCT02108730|"~     Observational study in patients with non-focal congenital hyperinsulinism showing that~     restrictive surgery may improve the metabolic situation~   "
111376|NCT02109640|"~     Two key requirements for discharge from hospital after major abdominal surgery are adequate~     oral analgesia and resumption of oral nutrition. Up to 40% of patients suffer delayed~     discharge after abdominal surgery due to delayed return of gut function, manifesting as~     nausea, vomiting, constipation and abdominal distension. Opiates and their derivatives are~     the mainstay of postoperative analgesic regimens after abdominal surgery and are highly~     effective in achieving adequate pain control. However, opioids cause impaired gut function by~     reducing normal forward propulsion and increasing gut spasm. Opioid receptor blockers such as~     Alvimopan counteract these effects and can accelerate postoperative gut recovery but are~     expensive and cause cardiac complications; alternative painkillers such as non-steroidal~     anti-inflammatories are less effective than opioids and have been linked with increased risk~     of anastomotic leaks.~      Targinact is a combination of prolonged release opioid analgesic (oxycodone hydrochloride)~     and naloxone hydrochloride (an opioid receptor blocker). The formulation of the product~     confines the naloxone action to the gut to reduce the unwanted side-effects on gut function.~     Targinact has been shown in patients with chronic severe pain to provide comparable analgesia~     to other opioid analgesics whilst reducing the unwanted side-effect of constipation.~      The Investigators wish to test the hypothesis that Targinact will provide adequate analgesia~     after colonic resection with reduced postoperative gastrointestinal dysfunction. The surgical~     procedure chosen to test this hypothesis is laparoscopic segmental colectomy, a consistently~     reproducible intervention with a postoperative gut dysfunction rate of up to 40% (prospective~     data from the Edinburgh Colorectal Unit). The main outcome of the study will be return of~     normal gut function at the time of planned discharge (Day 3).~   "
111377|NCT02109627|"~     The purpose of this study is to see if ficlatuzumab when combined with cytarabine, a standard~     treatment for AML, is safe to give to patients and to determine the best dose to give. The~     study doctors want to see what effects, good and/or bad, the study drug has on subjects and~     their AML. The study will look at what side effects subjects may have and how subjects feel~     after receiving the study drug.~   "
111378|NCT02109614|"~     Aortic valve disease is the most common form of heart valve disease and is a major burden to~     society. Aortic valve disease is also expected to become more prevalent with the aging of the~     Canadian population. Currently, over 1 million individuals in North America have aortic~     stenosis, which is a narrowing of the aortic valve, and leads to symptoms of heart failure~     and sometimes death. Valve replacement with its potential costs and complications remains the~     only avenue for treatment, once symptoms develop. Despite the major importance of this~     disease, there are currently no medical treatments to prevent the development of aortic~     stenosis.The lack of preventative treatments stems in large part to a poor understanding of~     the causes of this disease.~      Using cutting-edge genetic technologies, the investigators have recently identified that~     individuals with a genetic predisposition to elevations in a type of cholesterol not normally~     screened, called lipoprotein(a), have a much higher risk of developing aortic valve disease.~     The investigators have also shown that lipoprotein(a) causes hardening of the valve, a very~     early sign of valve narrowing. The investigators plan to evaluate in a randomized controlled~     trial whether lowering this unusual form of cholesterol at an early stage of this disease~     could slow or stop the development of aortic valve narrowing~      The investigators are currently proposing a pilot project to evaluate the feasibility of this~     type of study. If successful, our proposed treatment would be notable in two ways. First, it~     would represent the first medical treatment to prevent valve disease, which could lead to~     major reductions in the societal burden of this important disease. And second, it would~     herald a major success for genomic medicine as it would represent one of the first treatments~     borne from recent genetic studies. In these ways, our proposal could significantly impact the~     health of many Canadians while also highlighting the innovative research performed in Canada.~      Recruitment (n=238) for this project will be from the echocardiography laboratories of McGill~     University affiliated hospitals. Individuals with aortic sclerosis or mild aortic stenosis~     (aortic valve area [AVA] >1.5 cm2, mean gradient [MG] < 25 mmHG) and high Lp(a) will be~     eligible for inclusion into this proposed study.~   "
111379|NCT02109601|"~     RESEARCH QUESTION:~      Are hospitalized patients able to use a tablet computer (iPad) to take brief surveys, access~     their patient portal (MyChart), and watch informational videos about their condition?~   "
111380|NCT02109588|"~     The main aim of this study was to examine the effect of a supervised physical exercise~     program on the prevention of childhood obesity and its impact on the motor development of the~     offspring.~   "
111381|NCT02109575|"~     The primary goal of this Multicenter Study is to develop and to evaluate a method for~     measuring donor-specific cell free DNA in blood samples from transplant recipients as markers~     of rejection. Blood samples obtained periodically from heart transplant recipients are~     assessed for cell free DNA relative to clinical data in order to determine whether changes in~     the level of cell free DNA indicate rejection.~      This research study proposes testing a blood sample obtained from the heart transplant~     recipient. The research seeks to establish whether this blood test will show when the patient~     is beginning to or already rejecting the transplanted heart.~      BACKGROUND Identifying if a transplant patient is beginning to or already rejecting the heart~     is necessary, so that appropriate treatment can be started to halt the rejection. Heart~     catheterization with biopsy is the usual method used for assessing whether a patient may be~     rejecting the heart. There are also a number of other methods that transplant physicians will~     use to look for signs of rejection including other blood tests, echocardiograms, obtaining~     pressure readings during heart catheterization, and micro-array testing of blood obtained~     during biopsy. These technologies are limited in ability to consistently and accurately~     identify the presence of rejection.~      The usual method of checking for rejection involves obtaining a sample of the heart tissue~     (heart biopsy); biopsy can only be accomplished through heart catheterization which is an~     invasive procedure that has risks associated with disturbing the heart such as puncturing the~     heart or causing the heart rate to change or damaging tissue in the heart. Overtime,~     repeating this invasive procedure can diminish the ease of the procedure because the veins~     can become scarred and more difficult to access. For these reasons, researchers believe that~     it would be good to have a blood test that gives information about the possibility of~     rejection so that it may not be necessary to do as many heart biopsies. Also, a blood test~     may be able to provide information about the heart or about rejection that is currently not~     available at all.~   "
111382|NCT02109562|"~     The purpose of this study is to evaluate the efficacy and safety of RBP-7000 compared with~     placebo in the treatment of patients with schizophrenia.~   "
111383|NCT02109549|"~     There are preliminary data suggesting that patients suffering from non-insulin-dependent~     diabetes mellitus, treated with metformin, have improved local tumor control. A reduction in~     the tumor's hypoxia may be responsible for this phenomenon.~      Therefore, the aim of this study is to test the hypothesis in three cohorts of patients~     suffering from advanced stage non-small cell lung cancer and all undergoing concurrent~     radiochemotherapy: 1. Patients with diabetes mellitus treated with metformin only; 2.~     Patients with insulin-dependent diabetes mellitus not treated with metformin; 3. The~     remaining patients serving as controls. Furthermore, tumor and treatment-related parameters~     will be correlated with overall survival and morbidity.~   "
111384|NCT02109536|"~     The purpose of this study is threefold. First, the ability of experienced colonoscopists to~     recognize the type of loop formed will be assessed and whether the use of the MEI improves~     this accuracy. Second, to determine which maneuvers are used for loop reduction and whether~     certain loops have set ways to reduce them. The third component will assess whether the~     colonoscopist thought that the imager helped or not.~   "
111385|NCT02109523|"~     Coronary artery bypass grafting (CABG) surgery is often performed in elderly patients, but~     non-adherence to post-CABG guideline medications is a common and serious clinical concern in~     this age group. A recent systematic review found that higher medication adherence~     significantly improved primary and secondary prevention of coronary artery disease outcomes~     in all the included studies. Another systematic review assessed studies published from~     1999-2009 about motivational interviews, such as implementation intention, in relation to~     cardiovascular health. They found that motivational interview was an effective means of~     changing behavior, while offering promise in improving cardiovascular health status. The~     study is aimed to investigate effectiveness of long term volitional intervention in proving~     medication adherence in the CABG patient.~   "
111388|NCT02109484|"~     This is is a study of a parenteral rotavirus vaccine (P2-VP8 subunit rotavirus vaccine). The~     study will examine the safety and immunogenicity of this vaccine first in healthy South~     African toddlers. If the safety profile is deemed appropriate, the study will continue to~     explore the safety and immunogenicity of the vaccine in healthy South African infants.~      The primary safety hypothesis is that the P2-VP8 subunit rotavirus vaccine is safe and~     well-tolerated in healthy toddlers and infants. The primary immunogenicity hypothesis is that~     the P2-VP8 subunit rotavirus vaccine is immunogenic in infant participants and will induce an~     immune response in at least 80% of participants in at least one of the study groups.~   "
111389|NCT02109471|"~     A prospective observational study on corneal opacities (scar and stromal dystrophy) in adults~     (n=150) will be conducted at OHSU. The Optovue anterior segment OCT will be used to perform~     3-D corneal scans. These scans will be used to assess opacity depth and measure corneal~     thickness (pachymetry), corneal topography (anterior and posterior), and epithelial thickness~     maps. The ultrahigh-speed MIT OCT prototypes will also be used when they become available. A~     comprehensive eye examination, Placido-ring corneal topography, ultrasound pachymetry, and~     Scheimpflug camera imaging, will be performed for comparison.~   "
111390|NCT02109458|"~     The goal of this study is to evaluate the feasibility and safety of navigation guided virtual~     transthoracic needle biopsy combined with navigational bronchoscopy for the diagnosis of~     peripheral pulmonary nodules (PPN).~   "
111391|NCT02109445|"~     This study consists of a Phase 1b portion aimed to determine the maximum tolerated dose and~     the safety profile of PF-03084014 in combination with gemcitabine and nab-paclitaxel followed~     by a Phase 2 portion to evaluate the efficacy of the triple combination in terms of overall~     survival in patients with metastatic pancreatic ductal adenocarcinoma not previously treated~     with anticancer therapies.~   "
111392|NCT02109432|"~     The purpose of this investigation is to evaluate participant use of a dedicated office pedal~     desk with and without behavioral support.~   "
111393|NCT02109419|"~     While standard pencil-and-paper test have continued to be useful for the monitoring of~     cognition, mood, and life space (LS) in the elderly they do have considerable limitations.~     Use of these pencil-and-paper tests requires that individuals come to the clinic for~     assessments, which results in significant clinical costs and practical limitations in the~     conducting of assessments in large numbers of individuals, and provides a time consuming and~     non-automated means of quantifying and recording changes in brain function. It is~     increasingly recognized that there is a need to develop valid and reliable computer based~     assessments to allow for the remote assessment of cognition, mood, and LS. Development of~     computerized based assessments will significantly increase the scale, scope, and speed with~     which cognition, mood, and LS can be measured in the elderly.~      Helping Hands Technology LLC (HHT) has developed a number of web based assessments of~     cognition, mood, and LS. These new computerized assessments will be developed using new~     technology, and are based on the general principles found in existing pencil-and-paper based~     assessments of cognition, mood, and LS. In addition, HHT is developing proprietary means of~     reporting the results of the computerized assessments in an easy to use narrative format.~     This study will focus on quantifying the feasibility and validity of using HHT computerized~     assessments.~   "
111394|NCT02109406|"~     This is a phase IIa dose-ranging, randomized, double-blind, chronic-dosing (14 Days),~     three-period, placebo-controlled, multi-center, cross-over study to assess the efficacy and~     safety of two dose levels of a dual pharmacology molecule with the combined properties of a~     long-acting muscarinic antagonist (LAMA) and a long-acting beta-agonist (LABA); (AZD2115)~     delivered by a metered-dose inhaler (MDI) in subjects with moderate to severe chronic~     obstructive pulmonary disease (COPD).~   "
111395|NCT02109393|"~     The investigators evaluate whether an aerobic, intensive, goal based and multidisciplinary~     rehabilitation treatment, previously conceived for Parkinson's disease, is effective for~     patients with progressive supranuclear palsy and whether a driven gait orthosis (Lokomat) can~     provide further benefits.~   "
111396|NCT02109380|"~     In the present study, the effects of 7 days of bed rest on muscle mass, muscle fiber~     characteristics and insulin sensitivity will be determined.~   "
111397|NCT02109367|"~     This study involves women who are scheduled to have surgery for a pelvic or ovarian mass that~     is suspicious for epithelial ovarian cancer (EOC). The physician will perform an additional~     procedure on all consented subjects known as 'culdocentesis'. This will be done just prior to~     their scheduled surgery while the patient is under general anesthesia. Culdocentesis is a~     procedure typically used to check for abnormal fluid in the space just behind the vagina.~     This pocket of space is called the cul-de-sac. The purpose of this study is to determine if~     levels of tumor markers, CA-125 and HE4, are measurable from the cul-de-sac fluid. If these~     tumor markers are measurable from the cul-de-sac fluid and correlate with the patient's~     diagnosis, this procedure may be used in the future as an additional diagnostic tool for EOC.~     In addition, a single urine sample will be collected from each patient to measure the ratio~     of good to bad estrogen. Investigators hypothesize this ratio will also correlate with~     EOC diagnosis. Study results could lead to development of an alternative, minimally invasive~     and low risk diagnostic tool in patients with an ovarian mass suspicious for malignancy.~   "
111398|NCT02109354|"~     The HIV Vaccine Trials Network (HVTN) is doing a study to test 2 experimental HIV vaccines in~     combination with 2 licensed vaccines for tetanus and hepatitis B. HIV is the virus that~     causes AIDS. Tetanus is an infection that causes muscular spasms. Hepatitis B is a virus that~     can cause liver failure.~      About 100 people will take part in this study at multiple sites. The US National Institutes~     of Health (NIH) is paying for the study.~      We are doing this study to answer several questions.~        -  Are the HIV study vaccines safe to give to people?~        -  Are people able to take the HIV study vaccines without becoming too uncomfortable?~        -  How do people's immune systems respond to the HIV study vaccines? (Your immune system~          protects you from disease.)~        -  Can people's immune responses to a tetanus or hepatitis B vaccines help us understand~          how their immune systems might respond to the HIV study vaccines?~        -  Is there a common immune response to licensed vaccines like the tetanus and hepatitis B~          vaccines?~   "
111514|NCT02107807|"~     Evaluate the safety, immune response and reactogenicity of aH5N1 vaccination in adult (18~     through 60 years of age) and elderly (≥61 years of age) subjects with and without~     immunosuppressive conditions.~   "
111400|NCT02109328|"~     Background:~      Progress in developing new effective therapies in advanced and relapsing urothelial cancer~     has been stagnant in the last few decades and a paradigm shift is desperately needed. Aurora~     kinase-A overexpression has been previously described in bladder cancer and spindle~     checkpoint dysregulation is a common feature of human urothelial carcinoma (UC).~      Alisertib (Millennium Inc.) is an orally available, selective small molecule inhibitor of~     Aurora A kinase. Single agent and combination treatment of MLN8237 with either paclitaxel~     (TXL) or gemcitabine synergistically reduced UC cell viability compared with either drug~     alone. Hence, sequential application of MLN8237 and TXL warrants clinical investigation.~     Phase 1 trials of both single agent and the combination with TXL defined the recommended~     doses for phase 2 trials.~      Methods:~      A multistep approach will be adopted for this Phase 2 trial. A single-group run-in phase will~     be conducted first with Alisertib 50 mg orally BID for 7 days, followed by 14d rest until~     disease progression. In case of activity, a confirmatory randomized (1:1) trial of weekly TXL~     plus either Alisertib or Placebo will follow, incorporating efficacy and futility boundaries~     for early stopping. In a single-blind design, TXL will be given on days 1,8,15 q4wks at the~     dose of 60 mg/m2 with alisertib and 80 mg/m2 with placebo. Alisertib dose will be 40 mg BID~     days 1-3, 8-10 and 15-17, q4wks.~      In the single-arm phase, primary endpoint (EP) will be Response Evaluation Criteria in Solid~     Tumors (RECIST) 1.1 response-rate. 20 pts will be accrued, ≥3 responses will be required (10%~     type I and 20% type II error constraints). An accrual of 110 pts is foreseen in the~     randomized phase. Primary EP: progression-free survival (PFS), assuming an improvement in PFS~     from a median of 2.5 months (H0) to a median of 4.5 months (H1) (44% hazard rate reduction,~     10% drop out rate).~      Eligibility will include diagnosis of metastatic UC and failure of 1-2 CT regimens~     (single-arm) or 1 prior CT only (randomized phase). A relapse within 6 months of a~     peri-operative CT will be counted as 1 line. Computed tomography and PET will be done every 2~     cycles (2 months). Additional pharmacodynamic and translational analyses are planned on pre-~     post- blood and tissue samples.~   "
111401|NCT02109315|"~     To investigate the effect of liraglutide on vascular injury induced hypoglycemia in patients~     with type 1 diabetes mellitus. The vascular damage is evaluated at investigating the changes~     of endothelial function~   "
111402|NCT02109302|"~     The main objective of our study is to identify the first genetic etiology of primary~     Premature Ejaculation (PE). We will test and evaluate the existence of genetic determinism~     conferring susceptibility to a life-long syndrome (primary premature ejaculation) in some~     patients. To this end, we plan to establish a collection of biological samples and a database~     of patients with this extreme syndrome, which we will analyze by Genome Wide analysis. This~     will lead to improvements in the biological understanding, the knowledge of physicians of~     the disease, and should improve the patients' quality of life. Not all PE cases have the same~     physiopathology and treatment efficiency, which depend on the specific mechanism involved in~     the clinical context. Our work will make it possible to develop new therapeutic approaches~     suitable for a large proportion of individuals presenting PE. This integrative approach~     combining researchers, patients and ethics committees will facilitate profound reflection,~     promoting the creation of suitable structures capable of receiving patients for appropriate~     consultations. This unique study of PE should also favor industrial partnerships.~   "
111403|NCT02109289|"~     The primary goal of this preliminary project is to study the effect of etanercept, a medicine~     approved by Health Canada for the treatment of rheumatoid arthritis, on the inflammation of~     certain blood vessels. In particular, the inflammation of the aorta and the carotid arteries~     will be studied.~      This study's goal is to determine if etanercept (that blocks TNF (tissue necrosis factor)~     alpha) could have an effect on blood vessel inflammation. As well, the information from this~     study will be used to determine the number of patients to recruit in a future study.~      This study will evaluate the effect of etanercept on 10 patients with rheumatoid arthritis at~     one rheumatology clinic in Montreal. The 10 patients will be recruited at the Montreal~     Rheumatology Institute (Institut de Rhumatologie de Montréal) and the images of the blood~     vessels taken at a medical imaging center will be analyzed by the Montreal Heart Institute.~      To evaluate vascular inflammation subjects will undergo a PET scan (Positron Emission~     Tomography).~   "
111404|NCT02109276|"~     The proposed study will recruit patients with mild to moderate Fuch's dystrophy who need~     cataract surgery alone. They will be randomly assigned to receive either spheric or aspheric~     lenses. If both eyes of a patient need surgery, we will implant the same type of lens in each~     eye in order to prevent imbalanced vision. We will measure their contrast sensitivity and~     higher order aberrations before surgery and 3 months after surgery. We will compare the~     change in these values between the two groups.~   "
111405|NCT02109263|"~     The aim of this study is to compare the impact of two non-medicinal strategies: the~     breast-feeding and saccharose to measure effects in cerebral cortex during pain using near~     infrared spectroscopy (NIRS)~   "
111406|NCT02109250|"~     In this registry it is planned to include all Belgian patients diagnosed with aggressive and~     symptomatic unresectable locally advanced or metastatic Medullary Thyroid Cancer (MTC) who~     have been prescribed Caprelsa® (vandetanib).~      The characteristics of patients receiving Caprelsa® (vandetanib) will be described. Therefore~     real life data regarding demographic characteristics, evolution of the disease, RET mutation~     status, the treatment before, during and after vandetanib, dose and duration of treatment~     with Caprelsa® (vandetanib) and time of progression or death (if applicable) will be~     included.~   "
111407|NCT02109237|"~     This study is to determine whether sleep disorders contribute to impaired quality of life and~     mobility in patients with Bronchiolitis Obliterans syndrome and whether non invasive positive~     airways pressure ventilation can improve sleep, quality of life and mobility in this patient~     group.~   "
111408|NCT02109224|"~     This phase I trial studies the side effects and best dose of ibrutinib in treating B-cell~     non-Hodgkin lymphoma that has returned or does not respond to treatment in patients with~     human immunodeficiency virus (HIV) infection. Ibrutinib may stop the growth of cancer cells~     by blocking some of the enzymes needed for cell growth. It is not yet known whether it is~     safe for patients with HIV infection to receive ibrutinib while also taking anti-HIV drugs.~   "
111409|NCT02109211|"~     The purpose of this study is to see whether altering the angle of the Magill forceps by 45~     degrees will affect nasal intubation time in pediatric dental surgery patients.~      The null hypothesis is that their will be no difference between the nasal intubation times of~     those patients intubated with the conventional Magill forceps and those intubated with the~     altered Magill forceps.~   "
111725|NCT02105038|"~     The aims of the study are to better understand how upper extremity injury and immobilization~     influences a patient's steering ability. Patients with acute distal radius fractures treated~     with surgery will be recruited for study in a driving simulator. The results will hopefully~     assist physicians to better counsel patients with upper extremity injuries on when it is safe~     to return to driving.~   "
111410|NCT02109198|"~     The purpose of this study is to determine the feasibility of combining PoNS therapy with~     standard vestibular and balance therapy with the proposed double-blind design; evaluate~     preliminary indications of efficacy. This study is also evaluating recruitment rate,~     completion rate, device usability, and outcome measures feasibility.~        -  Goal for recruitment: 100% of 30 subjects meeting all inclusion criteria can be~          recruited over the 36 week pilot recruitment phase.~        -  Completion and compliance: 90% of subjects will complete the study, 90% of sessions~          within each subject will be completed, and for completing subjects, 100% of measures~          will be completed.~        -  Useability: all therapists and subjects must rate useability as good or better.~        -  Success of blind: subject accuracy at guessing group membership must be at or near 50%.~   "
111411|NCT02109185|"~     The study will compare the safety and efficacy of a generic mometasone nasal spray to the~     reference listed drugs in the treatment of seasonal allergic rhinitis. Additionally both the~     test and the reference formulations will be tested for superiority against a placebo nasal~     spray.~   "
111412|NCT02109172|"~     This study evaluated the safety and efficacy of once and twice daily TD-4208 and placebo when~     administered using a jet nebulizer for 7 days in a cross-over design to patients with~     moderate to severe chronic obstructive pulmonary disease.~   "
111413|NCT02109159|"~     The investigators will conduct a two-arm, randomized controlled trial of the effect of~     emotional content in online videos on the extent to which the video is disseminated~     (forwarded). Dissemination can be assessed in terms of the number of views which can increase~     as a result from sharing and forwarding of the video.~      In this study, an experiment video and a control video, both of which are approximately 2.5~     minutes long, will be uploaded on YouTube, the most visited video sharing website. The videos~     concern the WOMAN trial, a large RCT of tranexamic acid in postpartum hemorrhage. The~     experimental group will receive a video with strongly emotional content (an interview with a~     postpartum hemorrhage survivor and her husband). The control group will receive a short video~     in which a researcher conveys the same information (but without the first hand experience of~     the survivor and her husband). Otherwise, the two videos are identical.~      Participants, selected from clinicians and researchers in obstetrics and gynecology, will be~     randomly allocated to two groups. An e-mail with a link to either of the videos will be sent~     to the participants. In the e-mail, they will be asked to watch the video and forward the~     link to their colleagues if they find it helpful.~      The primary outcome is video forwarding. The secondary outcome is the number of access to the~     video that each participant generated.~      Data will be collected for 14 days after the e-mails are sent to the participants. The~     relative risk (RR) of forwarding the videos will be calculated as effect measure and compared~     using chi-square test. The distribution of the numbers of access to the video that each~     participant generated will be compared using Wilcoxon signed-rank test.~      The hypothesis is that an online video with emotional content has higher chance of being~     forwarded to other people and therefore, gets higher number of views than an less emotional~     online video.~   "
111414|NCT02109146|"~     1. Hepatocellular carcinoma (HCC) is the most common primary malignancy of liver,~          representing the third leading cause of cancer-related death worldwide.~        2. Its overall dismal prognosis is a result of high incidence rates of metastasis and~          postoperative recurrence, in particular the intrahepatic recurrence.~        3. TACE is the most widely used primary treatment for unresectable HCC. It was also used as~          the optional treatment of relapsed disease. However, the efficacy of TACE used as~          adjuvant therapy following hepatectomy remains controversial.~   "
111415|NCT02109133|"~     Intraocular pressure is significantly increase during robot-assisted laparoscopic radical~     prostatectomy which is performed in a steep trendelenburg position at prolonged times of~     pneumoperitoneum. Therefore investigators decided to evaluate the impacts of surgical~     visibility through deep neuromuscular blockade on intraocular pressure in patients undergoing~     Robot-Assisted Laparoscopic Radical Prostatectomy.~   "
111416|NCT02109120|"~     1. In carotid endarterectomy(CEA) surgery, the dynamic changes of plasma MMP9 concentration~          cross CEA will be identified.~        2. And the part of patients suffered particulate cerebral embolic injury, their MMP9 level~          will increase in the early stage after CEA.~   "
111417|NCT02109107|"~     The purpose of this study is to determine whether low level laser light therapy is effective~     in reducing circumference of the waist, hips, thighs and upper abdomen over a 6 week period.~   "
111418|NCT02109094|"~     The investigators seek to examine the metabolic changes that occur amongst obese and lean~     pregnant women with normal glycemic control as well as pregnant women with diabetes mellitus~     (gestational diabetes and pre-existing type 2 diabetes mellitus) compared to non-pregnant age~     matched controls. Given the adaptive tendency of the maternal body to use alternative energy~     sources such as ketones and free fatty acids rather than glucose and to shunt glucose and~     amino acids to the fetus, the investigators hypothesize that the amino acid and fatty acid~     profile will be reflective of this adaptive change and that maternal insulin resistance will~     result in alterations in this pattern in both the plasma and CSF. Furthermore, the~     investigators also hypothesize that maternal degrees of insulin resistance will also be~     reflected in CSF hormonal changes.~   "
111419|NCT02109081|"~     Postoperative delirium is commonly observed in elderly patients in the postanesthesia care~     unit (PACU) and during the first 2-3 days following surgical procedures. This is an important~     clinical problem in the geriatric surgical patient; morbidity and mortality rates are~     significantly higher in patients who develop delirium. At the present time, the etiology of~     delirium has not been precisely defined. However, studies suggest that inflammation related~     to the surgical stress response is an important contributing factor in inducing~     neuroinflammation and subsequent cognitive dysfunction and delirium. Therefore it is possible~     that agents which attenuate perioperative inflammation may reduce the risk of the development~     of delirium following surgery. Dexamethasone is a potent corticosteroid that is used by~     anesthesiologists primarily as an antiemetic agent. Small doses of dexamethasone have also~     been demonstrated to significantly reduce the release of inflammatory markers after surgery.~     The anti-inflammatory effects of corticosteroids have the potential to beneficially impact~     neuroinflammation and the risk of developing postoperative delirium. The aim of this~     randomized, controlled, double-blinded investigation is to determine if dexamethasone,~     administered at induction of anesthesia, can decrease the incidence of delirium at the time~     of discharge from the PACU and during the first 2 days following surgery.~   "
111420|NCT02109068|"~     The specific aims of this study are to determine the efficacy and cost-effectiveness of a~     weight loss program compared with usual care (control) treatment on 6-month changes in body~     weight, body fat, and serum hormones in breast cancer survivors.~   "
111748|NCT02104739|"~     This project addresses cardiovascular disease risk in patients with prediabetes. Levels of~     lipids after eating a meal (postprandial lipids) are strong independent predictors of~     cardiovascular risk. Newer anti-diabetic agents - exenatide and saxagliptin - impact lipid~     metabolism. These medications will be studied for their effect in reducing both postprandial~     lipid levels and arterial dysfunction.~   "
111421|NCT02109055|"~     The major cause of mortality worldwide is due to cardiovascular diseases. A way to treat~     these diseases is coronary artery bypass grafting, one of the most common surgical procedures~     in the world. The incidence of post-operative complications contributes to functional decline~     of the patient, reduced quality of life and post-discharge mortality. Also, cardiac surgery~     leads to changes in lung capacity and respiratory muscle strength, causing a decrease in the~     function lung. Physical therapy proves to be an effective tool to combat changes resulting~     from cardiac surgery, demonstrating beneficial results in the pulmonary function, functional~     capacity, and peripheral and respiratory muscle strength. The Pilates method has been studied~     as a therapeutic way to healthy subjects and various kinds of diseases, but there are no~     studies in the literature evaluating the effect method in patients after coronary artery~     bypass surgery.~      The aim of this study is to investigate the effect of Pilates on functional capacity , flows~     and lung volumes, respiratory and peripheral muscle strength after coronary artery bypass~     grafting.~      Randomized clinical trial in which patients will be eligible after elective coronary artery~     bypass surgery, randomly allocated into two groups : conventional physiotherapy group (n =~     15) and Pilates method associated with conventional physiotherapy group (n = 15). The~     outcomes will be assessed by blinded evaluator and data randomization will be performed~     through by electronic randomization.The interventions will take place during the length of~     stay in the hospital, totalizing a maximum of six days of intervention.~      It is expected that the application of the Pilates method exercise method associated with~     conventional physiotherapy in patients in postoperative coronary artery bypass grafting~     improves functional capacity, flows and lung volumes and respiratory and peripheral muscle~     strength.~   "
111422|NCT02109042|"~     The purpose(s) of this study is to measure how much of the study drug gets into the blood~     stream and how long it takes the body to get rid of it when given in multiple doses,~     subcutaneously (SQ) (by inserting a needle just under the surface of the skin in the lower~     abdominal area), to post-menopausal female participants. Information about any side effects~     that may occur will also be collected.~      This study will also be looking for special markers called biomarkers that can be used to~     study osteoporosis and/or the effects of the study drug.~      There will be 2 parts to this study. The first part will last approximately 6 weeks and the~     second part will last approximately 7 weeks.~   "
111423|NCT02109029|"~     LY2605541 is an investigational drug being developed for the treatment of diabetes mellitus.~     This study is designed to understand how the body handles the investigational drug, and to~     measure the quantity of LY2605541 in fat tissue. The study has two parts. It involves~     intravenous (IV) infusion of the investigational drug and a procedure to measure~     concentrations in the fat tissue. Both parts of the study will be conducted in participants~     with type 1 diabetes mellitus (T1DM). Part A and B of the study might take up to 7 weeks to~     complete.~   "
111424|NCT02109016|"~     The purpose of this study is to determine whether lucitanib is safe and effective in the~     treatment of patients with advanced/metastatic lung cancer and fibroblast growth factor~     (FGF), vascular endothelial growth factor receptor (VEGF), or platelet derived growth factor~     (PDGF) related genetic alterations.~   "
111425|NCT02109003|"~     Despite intermittent control of tracheal cuff pressure using a manual manometer, cuff~     underinflation and overinflation frequently occur in critically ill patients, resulting in~     increased risk for microaspiration and tracheal ischemic lesions.~   "
111426|NCT02108990|"~     Recent research has identified heightened sensitivity to social rejection as a core feature~     of BPD. Rejection sensitivity can trigger the aggressive, impulsive, and self-injurious~     behaviors characteristic of the disorder.~      Therefore targeting therapy towards the reduction of rejection sensitivity may improve the~     low rates of effectiveness of current pharmacological and behavioral therapies. Therefore,~     this proposal tests a theoretically-based pharmacological approach that specifically targets~     the heightened sensitivity to rejection experienced by BPD patients.~      In prior research with normal controls, it was shown that chronic treatment with the physical~     pain-killer acetaminophen (e.g. Tylenol) reduced both neural responses to social rejection~     (using fMRI) as well as self-reported feelings of rejection in a daily diary study.~      It is the aim of this research project to determine if the over-the-counter analgesic,~     acetaminophen (active ingredient in Tylenol), can reduce symptoms and behaviors in BPD~     patients. The goal of this proposal is to use an open-label design to determine if~     acetaminophen improves symptoms in BPD patients.~   "
111427|NCT02108977|"~     Genetic counseling has benefits for individuals and their family members in their health care~     decision-making. Provision of genetic counseling has been deemed standard of care by several~     medical organizations and incorporated into clinical guidelines, such as those of the US~     Preventive Services Task Force. To better comply with these guidelines, Genomic Medicine~     Service (GMS) recently established at the Salt Lake City, Utah VA medical center to provide~     genomic services and counseling as a part of VA Patient Care Services. For Veterans for whom~     in-person genetic counseling in not feasible, GMS conducts counseling either via telephone or~     videoconferencing. Although both of these methods can be effective for delivering genetic~     counseling, each has its relative advantages and disadvantages. The specific aim of this~     study is to gain a better understanding of the advantages and disadvantages of these two~     modalities. This information will be useful not only for genetic counseling but also other~     interventions that use telephone or videoconferencing to access patients.~   "
111428|NCT02108964|"~     To estimate the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) (Phase l~     part) of EGF816 and to investigate the anti-tumor activity of EGF816 (Phase II part).~   "
111429|NCT02108951|"~     The purpose of this Australian study was to assess the efficacy and safety of nilotinib 300mg~     twice daily in patients with chronic myeloid leukemia chronic phase who were intolerant but~     responsive to 1st line treatment with imatinib or dasatinib. Eligible patients have been~     previously treated with imatinib or dasatinib for at least 3 months and are experiencing~     non-hematologic toxicity whilst having documented responses that meet PBS authority for 1st~     line treatment of CML without current MR4.5.~   "
111430|NCT02108938|"~     The primary aims for this research are to 1) characterize brain changes in patients with CD~     compared to age and gender-matched controls and 2) relate these brain changes to measures of~     disease activity and pain severity.~   "
111431|NCT02108925|"~     The project will test the hypothesis that lung ventilation during exercise is unaffected by~     oxygen supplementation. In addition, the acute effect of oxygen supplementation on dyspnoea,~     heart rate and blood pressure will be studied.~   "
111432|NCT02108912|"~     This will be a randomized, matched-group study to compare the cardiopulmonary / metabolic~     benefits for persons post stroke that learn to walk utilizing early treadmill training~     post-acute stroke to persons post stroke that learn to walk utilizing non-treadmill based~     gait training during the same time period. Participants (n=30) will be adults who have~     completed acute rehabilitation following a stroke. Random assignment will be to either the~     ESTT or traditional gait training protocol during the outpatient rehabilitation phase.~        1. Group A: Traditional outpatient therapy (n = 15)~        2. Group B: Treadmill training (ESTT) outpatient therapy (n = 15)~   "
111433|NCT02108899|"~     When people are tested on a previously learned material, they will later remember it better~     even when compared to a condition where they can re-study it. This phenomenon is called~     retrieval practice and is supported by an extensive research literature mostly carried out in~     normal students. This paradigm begins to be used in cognitive remediation programs in~     patients suffering from memory difficulties.~      The objective of this study is to investigate whether retrieval practice is spared in~     patients with schizophrenia.~      If effective, this method could be used in cognitive remediation programs.~      Since episodic memory difficulties are supposed to be secondary to deficits in the~     initiation/elaboration of efficient encoding and retrieval strategies our hypothesis is that~     retrieval practice is spared in schizophrenia.~   "
111434|NCT02108886|"~     Preterm birth is a major public health problem, and actual treatments are not very efficient.~     The purpose of this study is to test the efficiency of a combined use of Montelukast and~     Nifedipine to treat preterm labor. Investigators aim to reduce uterine contractions more~     efficiently than with the use of Nifedipine only.~   "
111435|NCT02108873|"~     Our objectives were to estimate the prevalence of nonattendance at outpatient offices, to~     identify the characteristics of appointments for which nonattendance was more likely to~     occur, and to generate a predictive model that could be applied to each appointment to~     estimate the probability of nonattendance.~   "
111436|NCT02108860|"~     Multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy of~     abatacept to achieve sustained glucocorticoid-free remission in patients with relapsing~     non-severe granulomatosis with polyangiitis (Wegener's) (GPA) . Participants will be~     randomized 1:1 to receive either abatacept 125 mg or placebo administered by subcutaneous~     injection once a week. Participants will continue on study treatment for a minimum of 12~     months unless they experience a disease relapse or disease flare.~      Participants who experience a non-severe disease relapse, non-severe disease worsening, or~     who have not achieved remission by month 6 will have the option of entering an open-label~     trial period whereby they would receive open-label abatacept.~   "
111437|NCT02108847|"~     The purpose of this study is to determine whether ultrasound guided fascia iliaca blocks~     performed before surgery help to reduce pain after elective total hip replacements.~   "
111438|NCT02108834|"~     For more than 25 years, Regional Anesthesia has challenged anesthesiologists to determine~     whether it offers real benefits in terms of patient outcome from major surgery, compared with~     general anesthesia. Although it is clear that regional analgesia in association with general~     anesthesia substantially reduces postoperative pain, the benefits in terms of overall~     perioperative outcome are controversial. The aim of this study is to evaluate the effect on~     short and long-term postoperative outcomes of adding regional analgesia to general~     anaesthesia in thoridetomic patients.~   "
111439|NCT02108821|"~     A disturbance in the diversity of gut bacterial composition could be linked to several immune~     mediated diseases including inflammatory bowel diseases (IBD). IBD can be classified into~     Crohn's Disease (CD) and Ulcerative Colitis (UC). Both these diseases occur from abnormal~     immune reaction to resident gut bacteria.The process of fecal microbiota transplantation~     (FMT) where fecal bacteria from a healthy individual is transferred into a recipient, has~     recently received attention as an alternative therapy for individuals affected with these~     life-altering diseases. In this study, the investigators will perform fecal transplantation~     on the subjects meeting inclusion criteria, to determine the efficacy and safety of this~     therapy in subjects with IBD (CD and UC) who are not responding to first line therapy, and~     are in a flare.~   "
111440|NCT02108808|"~     Fractional flow reserve (FFR) is an established invasive method for assessing the~     physiological significance of coronary artery stenosis. Adenosine, an important endogenous~     regulator of coronary blood flow during both stress and ischemia, is widely used to achieve~     conditions of stable hyperemia required for measurement of FFR.~      Studies in healthy volunteers and in patients with acute coronary syndrome (ACS) post~     percutaneous coronary intervention (PCI) receiving ticagrelor revealed a differential~     coronary blood flow velocity response during increasing doses of adenosine compared to~     placebo or prasugrel treated subjects, respectively. It has also been demonstrated that~     patients treated with ticagrelor have increased plasma adenosine levels. Therefore, it has~     been hypothesized that the degree of hyperemia obtained with adenosine infusion may be~     greater in patients on ticagrelor than that obtained in patients taking clopidogrel or~     prasugrel. If this proves to be true, it would lead to a lower FFR value with possible~     important clinical implications in ticagrelor receiving patients in need for FFR measurement.~      This is a prospective, single center, randomized study of parallel design. Consecutive~     ticagrelor naive patients who are referred for coronary angiography and have an~     angiographically moderate to severe de novo stenosis (>50% and <90% diameter by visual~     assessment) in at least one major epicardial coronary artery amenable to PCI are candidates~     for this study. Patients after informed consent will be randomized (hour 0) to receive~     immediately post FFR (with adenosine iintravenous infusion at 140 μg/Kg/min for a 3 minute~     period) either ticagrelor 180mg loading dose or prasugrel 60mg/clopidogrel 600mg loading dose~     (as clinically indicated). FFR examination will be repeated 2 hours post loading dose.~   "
111441|NCT02108795|"~     The aim of the present study is to assess the effect of postoperative remifentanil infusion~     on the incidence of emergence agitation in preschool-aged children undergoing strabismus~     surgery with sevoflurane anaesthesia.~   "
111442|NCT02108782|"~     This phase II trial studies how well dovitinib lactate works in treating patients with~     pancreatic neuroendocrine tumors. Dovitinib lactate may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth.~   "
111443|NCT02108769|"~     Our aim is to analyze two ancient Tamil practices (chanting and breathing exercise) if they~     are capable of stimulating saliva containing agents that can be beneficial to the nervous~     system. Our study subjects will perform Tamil chanting and Tamil breathing exercise. Saliva~     will be collected before, during and after the exercises. We will quantify the specific~     proteins in these salivary samples. The results will benefit further studies in various~     patient populations.~   "
111444|NCT02108756|"~     The purpose of this study is to evaluate the safety and Efficacy of L- Pantoprazole sodium to~     treat upper gastrointestinal ulcer bleeding.~   "
111445|NCT02108743|"~     The purpose of this study is to determine if dynamic hyperinflation seen in patients with~     idiopathic pulmonary artery hypertension (iPAH) improves with albuterol therapy.~   "
111447|NCT02108717|"~     1. Purpose~           - The investigators aim to evaluate the feasibility of iPhone based remote control~          system as a real-time remote CT reading tool for suspected appendicitis under 3G network~          and the suboptimal illumination.~        2. Methods~             -  A total of 120 abdominal CT examinations; sixty had no findings of appendicitis,~               while the other sixty showed signs of acute appendicitis, were selected. The 16~               raters reviewed these images using an LCD monitor of the PACS workstation and also~               an iPhone which was connected to the PACS workstation via remote control system,~               grading the probability of presence of acute appendicitis on each examination by a~               five Likert scale.~             -  The investigators will compare the diagnostic performance between two devices.~   "
111448|NCT02108704|"~     It has been hypothesized, based on epidemiological observations, that Helicobacter pylori~     (HP) infection may play a role in the pathogenesis of Parkinson's Disease (PD). Previous~     studies have also shown that HP eradication therapy may result in improvements in levodopa~     pharmacokinetics and motor fluctuations. This study aims to examine the effects of HP~     eradication, using a double-blind randomized placebo-controlled trial design in a relatively~     large cohort of patients. Outcomes of interest include motor function, gastrointestinal~     symptoms and health-related quality of life. The investigators hypothesize that HP~     eradication will lead to improvements in motor function. The primary outcome of interest is~     the ON-medication Unified PD Rating Scale (UPDRS) Part III score at 3 months. Secondary~     outcomes include Purdue Pegboard Score, Timed Test of Gait, Dyskinesia and Bradykinesia~     scores measured by Parkinson's Kinetigraph (PKG), 72 hour Diary, Leeds Dyspepsia~     Questionnaire (LDQ), Parkinson's Disease Questionnaire (PDQ-39), UPDRS Part I, Part II and~     Part IV; and Montreal Cognitive Assessment (MOCA).~   "
111449|NCT02108691|"~     The investigators performed a 8-week, randomized, double-blind, placebo-controlled human~     trial to evaluate the efficacy and safety of Glycin max (L.) Merr. peel extract on decrement~     of body fat. The investigators measured decrement of body fat parameters , including Body Fat~     Mass, Percent Body Fat, weight and BMI(body mass index), and monitored their blood pressure.~   "
111450|NCT02108678|"~     The purpose of this research study is to examine whether a one-day group workshop,~     integrating principles from Acceptance and Commitment Therapy and Migraine Education, will~     result in greater improvements in depressive symptoms and functioning impairment in patients~     with comorbid migraine and depression than a similar one-day group workshop with Migraine~     Education only.~   "
111451|NCT02108665|"~     The main objective of this study is to compare the data of Hystérosalpingo-MRI with intra~     cavitary injection of diluted gadolinium salts with the classic hysterography, which allows~     to realize at once with no irradiating examination, a complete assessment of the female~     infertility.~   "
111452|NCT02108652|"~     This Phase II, single-arm study is designed to evaluate the effect of atezolizumab treatment~     in participants with locally advanced or metastatic urothelial bladder cancer. Participants~     will be enrolled into 1 of 2 cohorts. Cohort 1 will consist of participants who are~     treatment-naïve and ineligible for cisplatin-containing chemotherapy. The results of Cohort 1~     are reported separately (NCT02951767). Cohort 2 (reported here) will contain participants who~     have progressed during or following a prior platinum-based chemotherapy regimen. Participants~     in both cohorts will be given a 1200 milligrams (mg) intravenous (IV) dose of atezolizumab on~     Day 1 of 21-day cycles. Treatment of participants in Cohort 1 will continue until disease~     progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or~     unmanageable toxicity. Treatment of participants in Cohort 2 will continue until loss of~     clinical benefit or unmanageable toxicity.~   "
111453|NCT02108639|"~     Assess the effect of renal function on the blood levels of DCV, ASV, BMS-791325.~   "
111454|NCT02108626|"~     The aim of this study is to measure nicotine cue- and withdrawal-induced craving in current~     smokers under four distinct conditions: after smoking a conventional cigarette, an electronic~     cigarette (e-Cigarette) containing nicotine, an e-Cigarette without nicotine, and after~     taking a nicotine lozenge. Participants will be asked to attend four morning study visits~     after overnight smoking abstinence. Standardized questionnaires will be used to assess~     changes under each condition, allowing for the investigation of the efficacy of e-Cigarettes~     in reducing craving by replacing the behavioral component of smoking with minimal risk of~     adverse effects.~   "
111455|NCT02108613|"~     Approximately half of men treated for prostate cancer will be offered hormone deprivation~     therapy during their cancer experience. The secondary effects of this treatment can result in~     osteoporosis, cardiovascular disease, stroke, diabetes, and diminished sexual health. To~     promote healthy lifestyle choices for couples and maintain their intimacy and emotional~     health we propose the Living Well, an innovative program that combines nutrition, physical~     activity, and sexual health initiatives in one integrated service. This project will be~     piloted at the Vancouver Island Centre with an expected 100 patients over 1 year. Over a six~     month period both the experimental and control groups will have access to a workbook~     (designed for men with prostate cancer and on hormone deprivation therapy) and sexual health~     counseling. The experimental group will also have access to an exercise and a nutritional~     program and support by volunteers to keep motivated. Assessment will look at quality of life,~     physical factors, and biomarkers associated with secondary disease.~   "
111456|NCT02108600|"~     Randomized open label clinical trial in which 48 renal transplant recipients with~     inflammation in the 6 month allograft biopsy will either continue usual immunosuppression or~     receive monthly Actemra (Tocilizumab) infusions for 6 months in addition to usual~     immunosuppression.~   "
111457|NCT02108587|"~     This clinical trial studies how well optical coherence tomography works in staging patients~     with upper-tract urothelial carcinomas. Staging describes the severity of a person's cancer~     based on the size and/or extent (reach) of the original (primary) tumor and whether or not~     cancer has spread in the body. It also helps the doctor plan the appropriate treatment.~     Optical coherence tomography is a procedure that uses infrared light waves to give~     three-dimensional pictures of structures inside tissues and organs. The pictures are made by~     a computer linked to the light source. Optical coherence tomography may be effective in~     staging patients with upper-tract urothelial carcinomas.~   "
111458|NCT02108574|"~     This study will evaluate the effects of RHINIX™ nasal filters on seasonal allergic rhinitis~     (hay fever) in a park setting.~   "
111459|NCT02108561|"~     Breast cancer biomarkers are usually performed on core needle biopsy (CNB) specimens and are~     not routinely repeated on surgical specimens (SS). However, preliminary data suggests that~     testing these biomarkers, on SS when compared to CNB samples can lead to different results.~     Our hypothesis is that The aim of this study is to identify a group of women with invasive~     breast cancer who may benefit from additional HER2 testing on their SS to ensure that areas~     of HER2 amplification are not missed. Another aim is to determine whether further HER2~     testing on the SS in select patients would lead to changes in breast cancer treatment~     options.~   "
111460|NCT02108548|"~     The purpose of this study is to evaluate the safety and tolerability of single and multiple~     ascending oral doses of ASP7657 in healthy subjects.~   "
111461|NCT02108535|"~     The evidence is insufficient to determine whether the types of dressings containing silver~     differ as the time/proportion to complete healing of the wound and pain. We will analyze~     cost-effectiveness of these dressings in outpatients, considering the service provided by the~     National Public Health System.~   "
111462|NCT02108522|"~     Patients enrolled on this study will have received a stem cell transplant. After a~     transplant, while the immune system grows back the patient is at risk for infection. Some~     viruses can stay in the body for life and if the immune system is weakened, like after a~     transplant, they can cause life threatening infections.~      Patients enrolled on this study will have had an infection with one or more of the following~     viruses - Epstein Barr virus (EBV), cytomegalovirus (CMV), BK virus, JC virus, adenovirus or~     HHV6 (Human Herpes Virus 6).~      Investigators want to see if they can use a kind of white blood cell called T cells to treat~     infections of these viruses after a transplant. Investigators have observed in other studies~     that treatment with specially trained T cells has been successful when the cells are made~     from the transplant donor. However as it takes 1-2 months to make the cells, that approach is~     not practical when a patient already has an infection.~      Investigators have now generated multivirus-specific T cells (VSTs) from the blood of healthy~     donors and created a bank of these cells. Investigators have previously successfully used~     frozen multivirus-specific T cells from healthy donors to treat virus infections after bone~     marrow transplant and now have improved the production method to make it safer and target~     more viruses.~      In this study, investigators want to find out if they can use these banked VSTs to fight~     infections caused by the viruses mentioned above.~   "
111463|NCT02108509|"~     The purpose of this study is to define the prevalence of low bone density~     (osteopenia/osteoporosis) in patients with chronic pancreatitis. Secondary aims include~     investigating the prevalence of hypogonadism (low sex hormones) in patients with chronic~     pancreatitis and determining if hypogonadism and/or use of narcotic pain medications are risk~     factors for low bone density in this patient population.~        1. Hypothesis:~           Patients with chronic pancreatitis are at increased risk of low bone density~          (osteopenia/osteoporosis), and hypogonadism (low sex hormone levels) and narcotic pain~          medication use are independent risk factors for the development of low bone density in~          this patient population.~        2. The outcome measures include:~           i) Prevalence of low bone density (osteopenia/osteoporosis) in patients with chronic~          pancreatitis (as determined by DXA scan and fracture history).~           ii) Prevalence of hypogonadism (low sex hormones) in patients with chronic pancreatitis~          (as determined by sex hormone levels and clinical history).~           iii) Identification of hypogonadism and/or opioid use as risk factors for low bone~          density in patients with chronic pancreatitis (as determined by univariate and~          multivariate analysis of multiple risk factors).~        3. After obtaining written consent from potential subjects, a questionnaire will be~          performed outlining risk factors for low bone density. Dual X-ray absorptiometry (DXA~          scan) will be performed to evaluate for low bone density and a blood test will be~          performed to evaluate for low sex hormones, low levels of vitamin D, and other risk~          factors for low bone density.~   "
111464|NCT02108483|"~     This study will evaluate the potential of dapsone gel and its vehicle to cause a phototoxic~     reaction following irradiation of the skin under controlled conditions.~   "
111465|NCT02108470|"~     The aim of this study is to determine whether by incorporating an OHRQoL measure in dental~     practice will improve patient-dentist communication and enhance patient's satisfaction. The~     objective of this study is to evaluate and compare how useful a standardized OHRQoL~     assessment improves patient-dentist communication with regards to number of relevant OHRQoL~     issues addressed and percentage of most frequently items discussed between the intervention~     and control groups, assess the patient's active participation between the intervention and~     control groups and enhances patient's satisfaction between the intervention and control~     groups.~   "
111466|NCT02108457|"~     The purpose of this study is to determine the effect of specific bone marrow maps developed~     with18F-FLT PET/CT imaging on the ability to spare proliferating bone marrow using proton~     beam radiotherapy compared to IMRT. Participants will be 18 years of age or old with a~     history of gynecologic cancer. Subjects will undergo 3 FLT-PET scans (one before treatment,~     one during the course of RT, and one 2-5 weeks after initiation of RT). Scans will take place~     in the Department of Radiation Oncology.~   "
111467|NCT02108444|"~     This study is a retrospective analysis to explore the incidence of hepatitis B virus~     reactivation after withdrawal of prophylactic antiviral therapy, the efficacy and safety of~     chemotherapy, and overall survival rate in lymphoma patients with hepatitis B virus~     infection.~   "
111468|NCT02108431|"~     The purpose of the study is to determine, whether the urinary diversion via suprapubic~     cystostomy compared to transurethral catheterization after robot-assisted radical~     prostatectomy superior the postoperative patient comfort and reduce the postoperative~     bacteriuria.~   "
111469|NCT02108418|"~     1. To evaluate the pharmacokinetics (PK) and relative bioavailability of TG-2349, given as~          a new capsule formulation and as the original formulation of oral solution, after a~          single oral dose of 400 mg under fed condition in healthy volunteers.~        2. To evaluate the safety and tolerability of TG-2349 in healthy volunteers.~        3. To evaluate the ethnic differences in PK and safety between East Asian and Caucasian~          volunteers.~   "
111749|NCT02104726|"~     To compare relative efficacy of intraarticular steroid injection using anatomic landmarks vs.~     fluoroscopy guided technique in decreasing knee osteoarthritis pain 1 month after the~     procedure.~   "
111470|NCT02108405|"~     A total of ninety - five patients (54men and 41women) were included in the study. Fifty-eight~     patients developed septic complication during ICU stay (sepsis group). Forty seven patients~     were critically ill without evidence of infectious organism (SIRS group). At admission,~     Patients data include clinical status; SOFA score; central venous pressure; laboratory~     analysis and arterial blood gas analysis were measured. Routine cultures were obtained. The~     attending physician evaluated the patients for sepsis, severe sepsis, or septic shock as long~     as their stay in ICU. Memory B cells and Heinz bodies were monitored.~   "
111471|NCT02108392|"~     Pseudoxanthoma elasticum (PXE) is a rare multisystem disorder of autosomal recessive~     inheritance (OMIM# 264800) and an estimated prevalence between 1:25.000 and 1:100.000. PXE is~     characterized by calcification and fragmentation of connective tissue rich in elastic fibers.~     Due to its high content of elastic fibers, Bruch Membrane in eyes of patients affected by PXE~     becomes thickened and calcified. The ocular phenotype is characterized by angioid streaks and~     peau d'orange but also choroidal neovascularizations and chorioretinal atrophy thereby in~     part mimicking the phenotype of age-related macular degeneration. The disease is due to~     mutations of the ABCC6-gene coding for a transmembrane protein which is mainly expressed in~     the liver and kidney. It is hypothesized that ABCC6 is involved in the excretion of a yet~     unknown factor from the liver which inhibits systemic calcification. In animal models several~     candidates for this factor have been identified but direct evidence for such a factor in~     patients with PXE is still missing. The primary purpose of this study is to further~     investigate the ocular phenotype of patients with PXE using multimodal imaging and functional~     testing to delineate the impact of Bruch membrane pathology on the eye. Furthermore, possible~     systemic anti-calcification factors, as well as associations with the vascular alterations~     are investigated to gain more insights into the pathogenesis of PXE..~   "
111472|NCT02108379|"~     This study will investigate usability and compliance related to rhinix nasal filters for the~     treatment of seasonal allergic rhinitis (hay fever) during the natural grass pollen season in~     Denmark.~   "
111473|NCT02108366|"~     Each year, influenza A infection caused great mortality and morbidity, especially among the~     elderly and individuals with chronic illness. Many of these patients are 'late presenters'~     who are admitted to hospital a few days after symptoms onset and have developed complications~     secondary to immunodysregulation. Antiviral treatment with the neuraminidase inhibitor is of~     limited usage for patients who presented to the hospital 48 hours after symptom onset. Apart~     from ventilatory and extracorporeal membrane oxygenation support, treatment options for these~     patients are limited. Recent animal study has demonstrated that combinations of an antiviral~     agent with a COX-II inhibitor can reduce mortality in mice infected with influenza virus. The~     investigators therefore propose to enrol patients with severe influenza A infection requiring~     hospitalization and oxygen support on a randomized controlled trial with celecoxib.~   "
111474|NCT02108353|"~     EuRhythDia II is a multicenter, randomized, double-blind controlled study. The rationale of~     EuRhythdia is to explore the effects of 12 weeks of timed melatonin treatment on circadian~     rhythm, metabolic control and cardiovascular function in night shift workers. The 12 weeks of~     intervention will be followed by 12 weeks of washing out.~   "
111475|NCT02108340|"~     This study will evaluate the use of microwave radiometry in a population of patients~     diagnosed with acute appendicitis and treated with appendectomy. The main purpose of the~     study is to report the results of microwave radiometry as a diagnostic tool in acute~     appendicitis and compare those results with the commonly used ultrasonography.~   "
111476|NCT02108327|"~     Using of surgical blade may have less blood loss than unipolar electrocautery in Total Knee~     Arthroplasty (TKA).~   "
111477|NCT02108314|"~     Breast cancer is the leading female cancer in Singapore, but 3 in 5 women are not going for~     their regular mammography screenings at recommended frequencies despite 15 years of~     nationwide efforts by Breast Screen Singapore. The investigators aim to determine the~     efficacy of opportunistic health promotion for uptake of mammography screening in Singaporean~     women attending private sector primary care clinics in Singapore by implementing a simple and~     feasible questionnaire to identify potential candidates for mammography screening, coupled~     with recommendations by the primary care provider and a directed promotional video produced~     by Kandang Kerbau Hospital (KKH) that is aimed at addressing some of the barriers to~     screening.~   "
111478|NCT02108301|"~     The aim of the present trial is to evaluate whether the conversion of immunosuppression from~     tacrolimus to cyclosporine A induces changes in (i) hepatitis C-virus load, (ii) parameters~     of hepatic function and (iii) parameters of glucose tolerance in hepatitis C-positive renal~     transplant recipients.~   "
111479|NCT02108288|"~     OPC-1085EL ophthalmic solution, carteolol long-acting ophthalmic solution or latanoprost~     ophthalmic solution are administered once daily for 7 days and the effect on the blood~     concentration of carteolol and latanoprost in OPC-1085EL ophthalmic solution by formulating~     the combination drug will be determined.~   "
111480|NCT02108262|"~     This is a multicenter randomized, double-blind, placebo-controlled, parallel-group,~     dose-ranging phase 2b study to investigate the hepatic and renal safety and tolerability of~     multiple dose administration of two dose levels of CSL112 compared with placebo in subjects~     with acute myocardial infarction (AMI).~   "
111481|NCT02108249|"~     The purpose of this study is to evaluate the clinical, radiological, and surgical outcomes of~     the Annex™ Adjacent Level System for the treatment of adjacent level disease of the lumbar~     spine. The Annex™ Adjacent Level System is a spinal fixation system intended to be used with~     commercially available pedicle screw fixation systems in order to extend existing pedicle~     screw constructs. Subjects will be evaluated over a 2 year period and compared to historical~     control.~   "
111482|NCT02108236|"~     To determine the efficacy and safety of acupuncture for obesity and overweight people in~     China.~   "
111483|NCT02108223|"~     The investigators aimed to evaluate patients who had In-vitro fertilization treatment and who~     had COH (controlled ovarian hyperstimulation) cycles applying long protocol with GnRH~     (gonadotropin-releasing hormone) analogue with suboptimal response to the rFSH. The~     investigators evaluated and compared the addition of rLH, increasing the dose of rFSH and the~     control groups regarding the results of IVF in these patients.~   "
128340|NCT01887522|"~     Multicenter, open label, prospective study including successively a phase I trial and then a~     phase II trial Phase I : Open label, non-randomized, sequential dose escalation of both~     drugs, vinblastine and nilotinib.~   "
111484|NCT02108210|"~     Rationale: Chronic fatigue syndrome (CFS) is a medically unexplained syndrome for which no~     somatic or pharmacological treatment has been proven effective. Dysfunction of the cytokine~     network has been suspected to play a role in the pathophysiology of CFS. Although~     derangements of the cytokine network in CFS are controversial, a major problem is that many~     studies did not use adequate controls. In addition, all studies have been performed on~     peripheral venous blood of the patients. As cytokines mainly act in the tissues, e.g., the~     brain, the information that can be derived from peripheral blood cells is limited. The only~     information regarding the possible role of cytokines in the pathophysiology of CFS could come~     from intervention studies in which pathogenetically important cytokines are inhibited. A~     potentially relevant cytokine which can be blocked in humans without severe side effects is~     IL-1. Although it is plausible that these cytokines play a role in CFS, there is limited~     evidence for this.~      Objective: To investigate the effect on symptomatology of interference with IL-1 in CFS~     patients.~      Study design: A randomized placebo controlled study will be performed to determine whether~     interference with IL-1 is able to reduce fatigue and disabilities in CFS patients.~      Study population: Female CFS patients without psychiatric co-morbidity will be included in~     this study. Patients of the outpatient clinic of the Department of General internal medicine~     and the Expert Centre for Chronic Fatigue (ECCF) will be asked to participate in the study.~     Patients will be asked to bring a healthy neighbourhood control to their first study visit.~      Intervention: After inclusion patients will be randomized to receive one of the following~     treatments:~        -  interleukin-1 inhibitor Anakinra (IL-1Ra) for 4 weeks (N=25);~        -  placebo for 4 weeks (N=25).~      Main study parameters/endpoints: The primary outcome measure will be fatigue severity~     measured with the Checklist Individual Strength (CIS) at 4 weeks, measurement will be~     repeated up to 26 weeks.~      Secondary outcome measures will be:~        -  level of functional impairment measured with the Sickness Impact Profile (SIP8) total~          score;~        -  physical and social functioning assessed with the subscale physical functioning and~          social functioning of the SF-36;~        -  level of psychological distress assessed with the total score on the Symptom~          Checklist-90 (SCL-90);~        -  pain severity assessed with a Visual Analog Scale (VAS);~        -  cytokine measurement in blood (plasma and blood in Pax-gene tubes) and saliva (at~          protein and mRNA level);~        -  cortisol measurement in saliva and hair;~        -  microbiome determination in faeces;~        -  body temperature and pulse rate.~   "
111485|NCT02108197|"~     The investigators hypothesize that pregnant women with gestational diabetes will have a high~     incidence of sleep apnea, and that the treatment of sleep apnea will lead to improved glucose~     control in these women.~   "
111486|NCT02108184|"~     Comparison of the eradications rates of sequential therapy versus concomitant therapy of~     treatment of Helicobacter pylori infection in Korea.~      single center, randomized trial~        1. (pantoprazole 40 mg + amoxicillin 1.0g + clarithromycin 500 mg + metronidazole 500 mg)~          twice for 10 days~        2. (pantoprazole 40 mg + amoxicillin 1.0g + clarithromycin 500 mg + metronidazole 500 mg)~          twice for 14 days~        3. (pantoprazole 40 mg + amoxicillin 1.0g) twice for 5 days and subsequent pantoprazole~          40mg + clarithromycin 500 mg + metronidazole 500 mg) twice for 5 days~        4. (pantoprazole 40 mg + amoxicillin 1.0g) twice for 7 days and subsequent pantoprazole~          40mg + clarithromycin 500 mg + metronidazole 500 mg) twice for 7 days~      1st endpoint : Helicobacter pylori eradication rates (intention to treatment, per-protocol)~     2nd endpoint : adverse event(nausea, vomiting, dizziness, bitter sense) drug compliance~   "
111487|NCT02108171|"~     Most patients with preoperative varying degrees of stress, anxiety, which makes the stress~     response in patients and affect the normal conduct of anesthesia and surgery.The sympathetic~     system hyperexcitability prone to cause adverse cardiovascular events and affect~     postoperative recovery. However, phenobarbital, as the traditional premedication, has less~     sedative, weak anxiolytic and other shortcomings. Midazolam accompanied by inhibition of~     respiration,excessive sedation, easily induced delirium,prolonged recovery time and so on.~     Dexmedetomidine is a highly selective α2-adrenergic receptor agonist, it has sedative,~     anxiolytic, no inhibition of respiration, and also colorless, odorless, non-mucosal~     stimulation, nasal drip ease of administration, patient acceptance, comfortable. Therefore,~     dexmedetomidine as premedication has certain advantages. The purpose of this research is to~     study sedative effect, safety and the impact of anesthesia recovery period of intranasal~     dexmedetomidine premedication for suspension laryngoscopy.~   "
111488|NCT02108158|"~     A randomized, evaluator-blinded, comparative, study to evaluate the efficacy and safety of~     different injection volumes of botulinum toxin type A, Azzalure, in the glabellar lines.~   "
111489|NCT02108145|"~     Cholangiocarcinoma (CCA) is the most common biliary malignancy and the second most common~     hepatic malignancy after hepatocellular carcinoma (HCC). A majority of the CCA (50-70%) was~     presented in the area of the biliary duct bifurcation. Recent retrospective study included~     heterogeneous group of malignant diseases demonstrate that draining more than 50% of was~     associated with a longer median survival.~      However, in recent European Society of Gastrointestinal Endoscopy (ESGE) biliary stenting~     clinical guideline and Asia-Pacific consensus recommendations for endoscopic and~     interventional management of hilar cholangiocarcinoma (HCCA), whether we should deployment~     bilateral or unilateral metal stent for patients with HCCA was not clearly recommended due to~     the absence of randomized controlled trials.~   "
111490|NCT02108132|"~     Hemophilia is caused by a single-gene defect resulting in familial bleeding disorder. Small~     increase in gene products could transform a severe form of hemophilia into a mild one. Stem~     cells from extrahepatic sources are being considered for clinical applications in liver cell~     therapy as they possess high in vitro culture potential and could be used in transplant~     procedures. We studied the differentiation of bone marrow hematopoietic stem cells (BM-HSCs)~     from hemophilia patients' relatives into factor 8 (FVIII)-producing hepatocyte-like cells~     aiming to expand patients' donor options for partial replacement of mutant liver cells by~     healthy cells in hemophilia A patients which could manage the severity of the bleeding~     disorder.~      BM-HSCs from hemophilic families will be cultured in short-liquid hepatic induction medium.~     Appearance of hepatic phenotype will be evaluated by alpha-fetoprotein expression using~     immunocytochemistry. Functional evaluation of transdifferentiation will be done through~     detection of albumin synthesis using microalbumin assay kit, factor VIII activity by~     one-stage clotting assay and expression of FVIII messenger RNA( mRNA) by reverse~     transcription ( RT-PCR).~      Inducing the differentiation of BM-HSCs by in-vitro manipulation may become a valuable tool~     to provide a cell source for hepatocyte transplant procedures for treatment of hemophilia~     patients.~   "
111491|NCT02108119|"~     To demonstrate benefit of a probiotic product in adults with irritable bowel syndrome.~   "
111492|NCT02108106|"~     This is a dose escalation study that will be conducted in healthy volunteers. Multiple~     cohorts of volunteers will receive ascending oral doses of AG-348 to evaluate the safety and~     tolerability of a single oral dose of AG-348, the pharmacokinetics (PK) of a single dose of~     AG-348, and the pharmacodynamic profile of AG-348 with specific biomarkers assessed in the~     blood.~   "
111836|NCT02103582|"~     The Quit & Fit intervention will be designed as a 12-week study to promote smoking cessation,~     increase physical activity levels, and reduce weight gain through regular exercise and~     healthy nutrition for African American Women smokers.~      Patients will be assigned to the fitness intervention group or control groups by a computer.~   "
111493|NCT02108093|"~     The effect of retrograde autologous priming (RAP) on regional cerebral oxygenation (rSO2)~     still remains unclear, because studies are limited in sample size and study design, and~     because of the absence of prospective studies. The investigators hypothesize that RAP limits~     the degree of hemodilution and thereby limits prolonged intraoperative cerebral desaturation~     during cardiopulmonary bypass (CPB), compared to the conventional priming method.~      The primary objective of this study is to determine whether RAP limits the degree of~     hemodilution and limits prolonged intraoperative cerebral desaturation during cardiopulmonary~     bypass, compared to the conventional priming method. Prolonged intraoperative cerebral~     desaturation will be assessed by rSO2 desaturation score50. rSO2 desaturation score50 > 3000~     is associated with increased risk of cognitive decline. The investigators hypothesize that~     RAP limits the degree of hemodilution and thereby limits the incidence of rSO2 desaturation~     score50 > 3000 with a relative difference of 50%.~      The subjects who are divided in the RAP group, the retrograde autologous priming technique~     will be used, where the patient's own circulating blood partially will be replaced by the~     priming solution in the cardiopulmonary bypass. In the Control group the conventional priming~     method will be used. The main study parameters is rSO2 desaturation score50.~   "
111494|NCT02108080|"~     Background:~      - People with alcoholism have differences in their brains compared with healthy people.~     People who are dependent on alcohol also perform differently on behavioral tasks. Researchers~     want to find out more about these differences. They also want to see if these differences are~     related to DNA.~      Objective:~      - To see if differences in brain structure relate to personality and behavior differences in~     people with and without alcohol dependence.~      Eligibility:~      - Adults age 18 and older.~      Design:~        -  Participants will visit the NIH Clinical Center once during the study.~        -  Participants will be screened with a medical history, EKG, and physical exam. They will~          give blood and urine samples and undergo a psychiatric interview.~        -  Participants will be asked about their alcohol drinking, to see if they have an alcohol~          use disorder.~        -  Participants will play three computerized games. Some will play these games inside a~          magnetic resonance imaging (MRI) scanner.~        -  MRI: strong magnetic field and radio waves take pictures of the brain. Participants lie~          on a table that slides in and out of a cylinder. They will be in the scanner for about~          90 minutes. They may lie still for up to 20 minutes at a time. The scanner makes loud~          knocking noises. They will get earplugs.~   "
111495|NCT02108054|"~     Background:~      - Scientists know that alcohol use disorders affect brain structure. They want to know more~     about the effects of alcohol use disorders on a person s behavior. They want to develop tasks~     that can be done inside a scanner that can help them better understand these effects in later~     studies.~      Objective:~      - To develop tasks that investigate a person s behavior that can be used in later studies.~      Eligibility:~        -  Inpatient participants of another study. They must be physically healthy right-handed~          adults 18 60 years old.~        -  Healthy right-handed volunteers 18 60 years old.~      Design:~        -  Participants will be screened with medical history and physical exam. They will have an~          EKG to record heart activity. They will give blood and urine samples and have a~          psychiatric interview.~        -  Participants will have between one and three visits.~        -  Participants will be asked about their alcohol drinking to see if they have an alcohol~          use disorder.~        -  Participants will complete one of three simple computerized tasks either inside the~          magnetic resonance imagining (MRI) scanner or outside of it.~        -  The MRI scanner takes pictures of the brain. The scanner is a metal cylinder.~          Participants lie on a table that can slide in and out of the cylinder. They will be in~          the scanner for about 60 minutes. They may have to lie still for up to 20 minutes. The~          scanner makes loud knocking noises, but they will get earplugs.~   "
111496|NCT02108041|"~     Background:~      -How people respond to drugs depends in part on their genes. For some drugs, doctors can use~     an individuals genetic background to help in dosing the drug. Researchers want to know how~     doctors incorporate personalized or genomic medicine into clinical practice.~      Objective:~      -To study how physicians make personalized treatment decisions~      Eligibility:~      -Healthy adult primary care physicians who are internal (or family) medicine residents.~      Design:~        -  Participants will complete a screening form.~        -  Participants will put on a headset, called a head-mounted display, showing a virtual~          reality environment.~        -  The environment will contain an exam room and the virtual patient.~        -  After interacting with the virtual patient, participants will complete a series of~          survey measures.~        -  Participation will last for about 60 minutes. The virtual patient interaction and~          follow-up questions will be audio taped.~   "
111497|NCT02108028|"~     Background:~      - There are very few documents to help young adults living with advanced cancer discuss their~     concerns and end-of-life preferences. A new document, Voicing My CHOiCES, allows young adults~     to explain what kind of care they would want if they became unable to communicate or make~     medical decisions on their own. Researchers want to study if this document is helpful.~      Objective:~      - To study if Voicing My CHOiCES can reduce anxiety, improve sense of support, and improve~     communication about advanced care planning.~      Eligibility:~      - Adults 18 to 39 years old being treated for cancer.~      Design:~        -  Participants will answer questions about their age, gender, employment, religion,~          health, and marital status. They will also complete several brief questionnaires:~             1. General Anxiety Short Form~             2. Peace, Equanimity and Acceptance in the Cancer Experience~             3. Functional Assessment of Social Support~             4. Quality of Communication~             5. Prior Communication about Advanced Care Planning~        -  Then a health care professional will introduce Voicing My CHOiCES . Participants will~          review the document and comment on parts they find relevant. They will also say if any~          important items are missing. Participants will complete 3 pages of the document with the~          assistance of a health care provider. They will be asked for positive and negative~          observations.~        -  The second stage of the study will take place about 1 month later. Participants will~          repeat the brief questionnaires listed above. They will be asked if they shared any of~          the preferences they described when completing the 3 pages of Voicing My CHOiCES during~          visit 1 with a family member, friend, or health care provider. Research staff will ask~          the participant for permission to contact the people they spoke with in order to learn~          whether their conversations about the document were helpful. They will ask for feedback~          on how to make Voicing My CHOiCES more helpful.~   "
111515|NCT02107794|"~     The investigators' decision aid for patients with GD, GD Choice, will be the result of a~     user-centered participatory action research involving) synthesis of the best available~     evidence from the literature and real-world registry experience, ii) input and involvement of~     patients, clinicians and other stakeholders, iii) direct observation of encounters and iv)~     extensive field-testing. The goal is to create a decision aid that will be rigorously~     evidence-based, clear and complete, able to be used by clinicians with minimal training time,~     while satisfying extant standards for rigorous high-quality shared decision making tools.~   "
111498|NCT02108015|"~     Objective~      Ionotropic glutamate receptors are ligand-gated ion channels responsible for most of the~     excitatory neurotransmission in the mammalian central nervous system (CNS). Based on~     pharmacology, they have been grouped into three subtypes-NMDA, AMPA and kainate. In recent~     years it has become apparent that the receptors do not function alone, but in the company of~     auxiliary proteins that regulate their activity [1]. Some of these have been shown to~     modulate AMPA receptor trafficking, gating and pharmacology and are classified as~     transmembrane AMPA receptor regulatory proteins, or TARPs ( >=-2, >=-3, >=-4, >=-5, >=-7, and~     >=-8). Genetic data indicate a possible role of TARPs in schizophrenia, depression, epilepsy,~     neuropathic pain, and bipolar disorder [1]. In a preclinical collaboration with Eli Lilly, we~     developed a promising radioligand, 18F-TARP252 to image TARP >=-8 using positron emission~     tomography (PET).~      This protocol covers three phases:~        -  Phase 1: kinetic brain imaging to quantify TARP >=-8 in brain relative to concurrent~          measurement of the parent radioligand in arterial plasma;~        -  Phase 2: if 18F-TARP252 is successful in Phase 1, we will estimate the~          radiation-absorbed doses by performing whole body imaging;~        -  Phase 3: test-retest analysis of brain binding relative to concurrent measurement of the~          parent radioligand in arterial plasma.~      Study Population~      Healthy adult female and male volunteers (n=22, ages 18 - 55) will undergo brain imaging. An~     additional eight healthy volunteers will undergo whole body dosimetry analysis.~      Design~      For quantification of TARP >=-8, 22 healthy controls will have brain PET imaging using~     18F-TARP252 and an arterial line. Some of them will have a test-retest scan. Eight additional~     subjects will have a whole body PET scan for dosimetry. For dosimetry, no arterial line will~     be used.~      Outcome Measures~      To assess quantitation of TARP >=-8 with 18F-TARP252, we will primarily use two outcome~     measures: the identifiability and time stability of distribution volume calculated with~     compartmental modeling. In test-retest study, we will calculate the retest variability. We~     will assess whole-body biodistribution and dosimetry of 18F-TARP252 by calculating doses to~     organs and effective dose to the body.~   "
111499|NCT02108002|"~     Background:~      - Von Hippel-Lindau (VHL) disease is a rare gene disease. People with VHL often have a brain~     tumor called hemangioblastoma. Standard treatment for these tumors is risky surgery.~     Researchers want to find new ways to treat people who have the tumors. They want to see if a~     drug that fights other cancers might slow the growth of hemangioblastomas in some people with~     VHL. Some people with VHL have mutations that make abnormal proteins. Tumors form in such~     people because the abnormal protein is broken down quickly. The cancer drug may work in these~     tumors by preventing breakdown of protein.~      Objective:~      - To study how the drug vorinostat affects hemangioblastomas in people with VHL.~      Eligibility:~      - Adults at least 18 old with hemangioblastomas from VHL.~      Design:~        -  Participants must already be in study 03-N-0164. They must have tumor surgery scheduled.~        -  Participants must stop taking most medications 14 days before surgery.~        -  One week before surgery, participants will enter the hospital. They will be screened~          with medical history and physical and neurological exams. They will give blood and urine~          samples. Participants will have an electrocardiogram. For this test, small sticky~          patches are put on the arms, legs, and chest. Participants will lie still for a few~          minutes while a machine records heart rate and rhythm.~        -  Participants will take one vorinostat by mouth each day for 7 days.~        -  Participants will have blood drawn during the week to check for any side effects.~        -  Participants will have their tumor removed in surgery. Researchers will study the tumor~          tissue for the effects of the study drug.~        -  A nurse will call participants 1 month after surgery to check for side effects.~   "
111500|NCT02107989|"~     Objectives:~      The overall study objective is to compare the sensitivities and specificities of morphometric~     analysis techniques using structural MRI images based on pre- and postsurgical localization~     of epileptic foci in patients undergoing presurgical evaluation for medically refractory~     epilepsy. To carry out these analyses, we aim to establish an age-stratified normative~     imaging database using healthy volunteers. Additional objectives are to identify abnormal~     networks in these patients using resting state fMRI/EEG and MEG/EEG, and to use language and~     memory fMRI tasks to examine the effects of epileptogenic zones and surgery on cognitive~     function and the networks associated with these functions.~      Study population:~      150 adults and children (age 8-65) with uncontrolled focal epilepsy, and 100 age-stratified~     healthy volunteers.~      Design: A retrospective and prospective natural history study. Research procedures for~     patients in this study include neuropsychological testing and 1-4 MRI sessions during~     presurgical evaluation and an additional 1-3 MRI sessions and neuropsychological testing~     approximately 12 months post-operatively. Research testing (such as research~     neuropsychological tests or MRI scanning sequences) will be done during a visit for clinical~     testing whenever possible, likely reducing the number of required visits. Patients will also~     have optional MEG and 7T structural imaging. Data will also be obtained from patients who~     have already undergone epilepsy surgery if they had procedures as outlined in the protocol~     and are willing to share the data. Healthy volunteers will receive a subset of the~     pre-operative procedures for patients, requiring at least 3 visits. In order to ensure~     adequate data acquisition, subjects may be re-scanned up to three times for the portions of~     the study in which they participated, possibly requiring additional visits.~      Outcome measures:~      The main outcomes will be establishment of normative values for morphometric analysis methods~     in age-stratified normal controls, and comparison of the sensitivity and specificity of these~     measures to pre- and postsurgical localization of the epileptogenic zone. Secondary outcome~     measures will include determination of the sensitivity and specificity of source localization~     using MEG/EEG and resting state fMRI/EEG, and to evaluate changes in activation during rest,~     as well as language and memory fMRI tasks in patients pre- and postsurgically, to examine the~     effects of epileptogenic zones and surgery on cognitive function and the networks underlying~     these functions.~   "
111501|NCT02107976|"~     Diabetes type two is a debilitating disease that leads to chronic morbidity such as~     accelerated microvascular disease. Accelerated microvascular disease may produce blindness,~     end stage renal disease, myocardial infarction, stroke, and limb ischemia. Strategies to~     prevent or delay microvascular disease have the potential to improve the lives of millions~     and prevent catastrophic illness. The major focus of prevention of microvascular disease in~     diabetes has been on the endothelium and its role in protection of blood vessels. An~     unexpected means to prevent microvascular disease in diabetes may be coupled to the function~     of vitamin C in red blood cells (RBCs) of diabetic subjects. Based on new and emerging data,~     vitamin C concentrations in RBCs may be inversely related to glucose concentrations found in~     diabetes. Based on animal data, we hypothesize that RBCs with low vitamin C levels may have~     decreased deformability, leading to slower flow in capillaries and microvascular hypoxia, the~     hallmark of diabetic microangiopathy. Low vitamin C concentrations in RBCs of diabetic~     subjects may be able to be increased, by using vitamin C supplements. Findings in animals may~     not accurately reflect effects in humans because of species differences in mechanisms of~     vitamin C entry into RBCs. Therefore, clinical research is essential to characterize vitamin~     C physiology in RBCs of diabetic subjects. In this protocol we will investigate physiology of~     vitamin C in RBCs of diabetic subjects as a function of glycemia, with and without vitamin C~     supplementation. We will screen type II diabetic subjects on insulin and select those with~     low vitamin C levels and hemoglobin A1C concentrations of 8-12%. Selected subjects will be~     hospitalized twice, each time for approximately one week. As inpatients, subjects will have~     two venous sampling periods each of approximately 24 hours. For the first sampling period,~     controlled hyperglycemia will be induced by withdrawing insulin and providing a high~     carbohydrate load diet (70-75% carbohydrate). Hyperglycemia will not exceed 9 hours, and will~     be reversed by reinstituting insulin. The second sampling period, also for 24 hours, will be~     performed under conditions of euglycemic control.~      During the two sampling periods, samples will be withdrawn via venous catheter for RBC~     deformability and vitamin C concentrations. At discharge, subjects will be placed on a~     vitamin C supplement and seen as outpatients at weekly intervals. After 3 or 6 weeks~     (depending on RBC vitamin C levels), subjects will be hospitalized again, and sampling~     repeated as described. In this manner, each subject serves as his/her own control, and~     deformability of red blood cells can be determined in relation to glycemia and to vitamin C~     concentrations in RBCs and plasma.~   "
111516|NCT02107781|"~     The investigators will monitor the pressure generated inside the abdomen in a patient in whom~     the surgeon, for whatever reason, felt that the abdomen could not be closed at the initial~     operation. The investigators will aggressively treat rises in intra-abdominal pressure and~     see what changes, if any are found when the abdomen finally is closed.~   "
111517|NCT02107768|"~     The purpose of this study was to investigate the effects of early intensive aerobic exercise~     regarding aerobic capacity, gait and balance, Health Related Quality of Life and~     participation.~   "
111837|NCT02103569|"~     The purpose of this study is to assess the effect of DCV/ASV/BMS-791325 fixed dose~     combination (FDC) + 75mg BMS-791325 on the Pharmacokinetics (PK) of the oral contraceptive~     agent.~   "
111502|NCT02107963|"~     Background~      GD2 is a well-characterized tumor antigen in neuroblastoma, which is also expressed on~     osteosarcomas and some other sarcomas. T cells expressing 1st generation anti-GD2 chimeric~     antigen receptors (CARs) were safe and mediated modest antitumor activity in some patients~     with refractory neuroblastoma.~      A 3rd generation anti-GD2-CAR (GD2-CAR.OX40.28.z.ICD9) has been produced and holds promise~     for increased activity compared to the 1st generation GD2-CAR already studied in clinical~     trials. As an added safety measure, the vector includes a suicide switch comprising a caspase~     dimerization domain (ICD9) that can be activated by a small molecule to induce death of the~     genetically engineered cells if they were induce untoward toxicity.~      Objectives~      Primary:Determine the feasibility of producing anti GD2-CAR cells meeting the established~     release criteria and to assess the safety of administering escalating doses of anti-GD2-CAR~     engineered T cells in children and young adults with GD2+ solid tumors, including~     neuroblastoma, following cyclophosphamide-based lymphodepletion.~      Secondary:~        1. Determine if administration anti-GD2-CAR engineered T cells mediate antitumor effects in~          children and young adults with GD2+ solid tumors;~        2. Measure persistence of adoptively transferred anti-GD2-CAR T cells and correlate this~          with antitumor effects;~        3. Extend information regarding the prevalence and intensity of GD2 expression in~          non-neuroblastoma, non-osteosarcoma solid tumors in children and young adults;~        4. If unacceptable toxicity occurs that is possibly, probably or likely related to~          anti-GD2-CAR T cells, assess the capacity for AP1903, a dimerizing agent, to mediate~          clearance of the genetically engineered cells and resolve toxicity; and~        5. Assess toxicity of AP1903 if administered to mediate clearance of anti-GD2-CAR T cells.~      Eligibility~      Patients 1-35 years of age, at least 15 kg, with osteosarcoma or a GD2+ solid tumor~     (including neuroblastoma) that has recurred after or not responded to standard therapy and is~     deemed incurable by standard therapy.~      Design~      After apheresis to collect T cells for transduction, patients receive cyclophosphamide~     1800mg/m(2)/d as a lymphodepleting regimen. A phase I cell dose escalation scheme will used~     at 4 dose levels (1 x 10(5) transduced T cells/kg; 1 x 10(6) transduced T cells/kg; 3 x 10(6)~     transduced T cells/kg; and 1 x 10(7) transduced T cells/kg), using a standard 3 plus 3 dose~     escalation design. An expanded group of a total of 12 patients will be treated at the highest~     dose, comprising at least 6 osteosarcoma patients.~      Patients will be monitored for toxicity, antitumor effects and persistence of anti-GD2-CAR T~     cells.~      Patients with a PR, SD may receive a 2nd cycle at the next higher dose level a minimum of 60~     days following completion of the first cycle if eligibility criteria are met.~      A maximum of 36 patients may be treated on this study. Given that there is likelihood that~     some patients with non-osteosarcoma will not meet the criteria for GD2 expression to be~     eligible for enrollment, up to 72 subjects will be screened to enroll a maximum of 36~     patients for treatment. Up to 2-3 patients will be accrued per month, and therefore this~     study may require up to 2-3 years to complete enrollment and treatment.~   "
111503|NCT02107950|"~     The purpose of this study is to determine whether DCVAC/OvCa added to chemotherapy~     (carboplatin and gemcitabine as second line chemotherapy) may result in prolongation of~     progression free survival (PFS).~   "
111504|NCT02107937|"~     The purpose of this study is to determine whether DCVAC/OvCa added to chemotherapy~     (carboplatin plus paclitaxel as first line chemotherapy) may result in prolongation of~     progression free survival (PFS).~   "
111505|NCT02107924|"~     The purpose of the study is to gather information on the use of Stimulan, the surgery, and~     anitbiotics to whetether the APPI has decreased or shown improvement when compared to study~     participants who did not receive Stimulan during their revision total knee replacement~     surgery.~   "
111506|NCT02107911|"~     The potential participants will be informed of the study details, including the study~     objectives. Once they have read the study information sheet and have a good understanding of~     the study, those who intend to participate in the study will be asked to sign the consent~     form for this study. There are 2 groups of participants: MSM who seek HIV voluntary~     counseling and testing service (phase I) and MSM who meet nPEP criteria (phase II).~   "
111507|NCT02107898|"~     Primary Objective:~      To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as~     add-on therapy to stable daily statin therapy with or without other lipid modifying therapy~     in comparison with placebo after 24 weeks of treatment in heterozygous familial~     hypercholesterolemia (HeFH) or high cardiovascular risk participants with~     hypercholesterolemia.~      Secondary Objectives:~        -  To evaluate the effect of alirocumab in comparison with placebo on LDL-C after 12 weeks~          of treatment.~        -  To evaluate the effect of alirocumab on other lipid parameters.~        -  To evaluate the long-term effect of alirocumab in comparison with placebo on LDL-C after~          52 weeks of treatment.~        -  To evaluate the safety and tolerability of alirocumab.~        -  To evaluate the development of anti-alirocumab antibodies.~        -  To evaluate the pharmacokinetics of alirocumab.~   "
111508|NCT02107885|"~     This is a randomised, double-blind, placebo-controlled and ascending single dose study. It is~     hypothesised that single oral doses of DS-1971a within the planned dose range will be safe~     and well tolerated by healthy male subjects.~   "
111509|NCT02107872|"~     This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose~     study to assess the safety, tolerability, pharmacokinetic (PK), immunogenicity, and~     pharmacodynamic (PD) effects of REGN1500 in patients with a metabolic disorder.~   "
111510|NCT02107859|"~     This is a Phase 3, multicenter, open-label, safety and efficacy study of ataluren in patients~     with nonsense mutation cystic fibrosis who participated in the previous Phase 3 study with~     ataluren (PTC124-GD-009-CF; Study 009).~   "
111511|NCT02107846|"~     This is an open-label, dose escalation study to evaluate the safety of oral PRX-112 and~     pharmacokinetics of GCD in subjects with Gaucher disease naive to enzyme replacement therapy.~     The dose levels of PRX-112 are 50 units, 100 units, 200 units and 400 units GCD. Subjects~     will receive once daily oral administrations of PRX-112 for 5 consecutive days at each dose~     level with a 2-day washout period between doses.~   "
111512|NCT02107833|"~     : This is a Phase I, study to evaluate the safety and pharmacokinetics of oral OPRX-106 in~     healthy volunteers. Up to 18 healthy male subjects (age 18 years and older) will be~     randomized to one of three dose cohorts (up to 6 subjects per cohort), receiving OPRX-106~     doses equivalent to 2mg, 8mg or 16mg Tumor Necrosis Factor receptor-Fc fusion protein.~     Subjects will receive once daily oral administrations of OPRX-106 for 5 consecutive days.~     Subjects will remain at the clinical center for 24 hours after the first administration (Day~     1) of OPRX-106 including PK sampling and then return to the site daily for additional~     administrations and study procedures.~   "
111513|NCT02107820|"~     Overactive Bladder (OAB) is a chronic condition defined as urgency with or without~     incontinence usually associated with frequency and nocturia. It is a common condition~     affecting 15-45% of adults and constitutes a significant proportion of patients attending~     urogynaecology clinics. OAB is known to have a significant impact on the physical, social and~     emotional quality of life and sexual function in women. The treatment of OAB is initially~     conservative with bladder training followed by pharmacotherapy.~      Evidence from a recent Cochrane review on treatment of OAB suggests that the efficacy of~     anticholinergics in treatment of OAB is enhanced when combined with BT. Women who fail to~     improve with these initial measures are offered Intravesical Botox or neuromodulation in the~     form of Percutaneous Tibial Nerve Stimulation (PTNS) or Sacral Nerve Stimulation (SNS).~      PTNS has also been shown to more effective than pharmacotherapy with anticholinergics. In~     2010 National Institute of Clinical Excellences (NICE) issued guidance stating 'PTNS for OAB~     demonstrates effectiveness without major safety concerns~      We hypothesise that the outcome of PTNS will improve if the PTNS sessions are combined with~     bladder training (BT).~   "
111518|NCT02107755|"~     This phase II trial studies the effectiveness of the combination of stereotactic radiation~     therapy and ipilimumab in patients with metastatic melanoma that has spread to four or fewer~     sites in the body (oligometastatic). Stereotactic radiation therapy is a type of external~     beam radiation therapy that uses special equipment to position the patient and precisely give~     a either a single large dose of radiation therapy to a tumor or several large doses of~     radiation therapy to a tumor using precision and accuracy that is guided by onboard daily~     imaging prior to radiation therapy. Monoclonal antibodies, such as ipilimumab, can block~     tumor growth in different ways. Some monoclonal antibodies find tumor cells and help kill~     them or carry tumor-killing substances to them. Giving stereotactic radiosurgery together~     with ipilimumab may kill more tumor cells by causing addition melanoma antigens to be~     presented to the immune system.~   "
111519|NCT02107742|"~     This study will investigate the influence of injection speed on pain during injection of~     lidocaine. It is anticipated that a longer injection time will lead to less pain for the~     patient during the injection. This hypothesis will be tested on healthy volunteers, who will~     each receive three injections with the same amount of lidocaine subcutaneously on the~     abdomen. The injections will be given over 15, 30 and 45 seconds. After each injection, the~     subject will be asked to evaluate the pain on a Visual analog scale (0-100 mm). The aim of~     the study is to find a simple method for pain reduction that can be used in clinical~     practice.~   "
111520|NCT02107729|"~     This study will investigate the influence of needle gauge on pain during injection of local~     anaesthetic. Healthy volunteers will be recruited, who will each receive three injections~     with either 21G, 23G or 27G subcutaneously on the abdomen. After each injection, the~     participants will be asked to evaluate the pain on a Visual analog scale (0-100 mm). It is~     anticipated that the pain will decrease with decreasing thickness of the needle. The aim of~     this study is to find a simple method for pain reduction that can be used in clinical~     practice.~   "
111521|NCT02107716|"~     This study will investigate the influence of adjusting the pH of lidocaine on pain during~     subcutaneous injection. Each participant will receive two injections on the abdomen with~     different pH. After each injection, the subject will be asked to evaluate the pain on a~     Visual analog scale (0-100 mm). It is anticipated that the pain decreases with increasing pH.~     The aim of the study is to find a simple method for pain reduction that can be used in~     clinical practice.~   "
111522|NCT02107703|"~     The main purpose of this study is to compare progression-free survival for women with hormone~     receptor positive (HR+), human epidermal growth factor receptor (HER2) negative advanced~     breast cancer receiving either abemaciclib+fulvestrant or fulvestrant alone. Participants~     will be randomized to abemaciclib or placebo in a 2:1 ratio. The study will last about 9~     months for each participant.~   "
111523|NCT02107690|"~     This study will investigate the influence of lidocaine temperature on pain during injection~     of lidocaine. Each participant will receive three injections subcutaneously on the abdomen~     with different temperatures. After each injection, participants will be asked to evaluate the~     pain on a Visual analog scale (0-100 mm). It is anticipated that the pain decreases with~     increasing temperature. The aim of the study is to find a simple method for pain reduction~     that can be used in clinical practice.~   "
111524|NCT02107677|"~     This study assesses the specificity of DENV Detect™ NS1 ELISA versus standard reference tests~     (e.g. PCR or viral culture) for dengue diagnosis in the US.~      DENV Detect™ NS1 ELISA serves as an aid in the clinical laboratory diagnosis of early stages~     of Dengue infection in patients with clinical symptoms consistent with Dengue infection. This~     test is intended to be used on sera obtained within the first 7 days of symptoms. DENV~     Detect™ NS1 ELISA and rapid test results (positive or negative) must be confirmed by testing~     with a reference standard test.~      This study will use archived, leftover human serum samples that have been sequentially~     collected from areas non-endemic for Dengue infection. Each specimen must have been collected~     within the first 7 days of symptoms, and must be accompanied by clinical data demonstrating~     that the individual had symptoms consistent with Dengue infection. The samples will have no~     personally identifiable information.~      ELISAs and reference tests will be performed by different operators who are laboratory staff~     members. These staff members, blinded to each other's results, will evaluate the samples from~     each method independently.~   "
111525|NCT02107664|"~     Radiation therapy (RT) is one of the primary treatments for bone cancer pain due to~     metastatic cancer disease. About 6 of 10 patients obtain pain relief from RT. There are no~     established predictors that can be used to select patients that respond to RT. This raises~     the need to identify potential clinical characteristics and biomarkers that may better select~     patients for RT. A similar argument can be stated for the development of cachexia; there are~     currently no predictors that can identify patients who will develop cachexia later in the~     cancer disease trajectory. Cancer symptoms can be related to inflammation. Both pain,~     cachexia and depression are associated with inflammation in experimental and preclinical~     studies . Still, the clinical data on the relationship between inflammation and pain or~     cachexia are sparse. This is especially true for longitudinal follow-up studies.~      This study will include 1000 adult patients in a multicenter, multinational longitudinal~     observation study of patients who receive radiation therapy for bone cancer pain. Demographic~     data, clinical variables, genetic biomarkers and inflammatory substances will be assessed~     before start of RT. The primary analysis in the study is to identify potential predictors for~     pain relief from RT. During follow up the study will also explore for predictors for~     development of cachexia and which inflammatory substances that are associated with changes in~     pain intensity, depression and development of cachexia.~   "
111526|NCT02107651|"~     Serious adverse events in patients treated with new oral anticoagulants are underreported.~   "
111541|NCT02107456|"~     Myofascial trigger point is one of the most common causes of musculoskeletal disorders.~     Myofascial trigger point in upper trapezius has been reported as a symptom in patients with~     neck and upper thoracic pain. The purpose of this study was to investigate the prolonged~     effect of dry needling on myofascial trigger point in upper trapezius muscle.~   "
111833|NCT02103621|"~     This study will address questions of fundamental clinical significance including: (1) whether~     OCD patients maintained on long term SRIs can be discontinued without symptom exacerbation,~     (2) whether trans-diagnostic cognitive-behavioral treatment will reduce worsening following~     discontinuation compared to Taper and Monitoring, and (3) whether predictors of successful~     SRI discontinuation can be identified.~   "
111527|NCT02107638|"~     Parkinson's disease (PD) is defined as a progressive disorder of the nervous system that~     affects the patient's mobility, balance and cognition. Tremor, slowed movements, and rigidity~     are physical symptoms which contribute to postural and gait abnormalities seen in many PD~     patients. Other symptoms include loss of balance and restricted range of motion, increasing~     the risk of falling. Osteopathic manipulative medicine (OMM) is a form of manual treatment~     provided by osteopathic physicians. This form of treatment aims to help decrease muscle~     spasms and improve joint range of motion and movement. We are proposing a pilot study to~     investigate the impact of OMM on balance, motor function, and falling in PD patients. We are~     also going to screen for serum biomarker changes to investigate the potential effects of OMM.~     Our research team and institution have experience in providing osteopathic care and physical~     rehabilitation for PD patients. In this study, balance and motor function will be evaluated~     for each subject throughout the study period. We will also keep track of the number of falls.~     Balance will be measured using Sensory Organization Test (SOT) and motor function will be~     measured using Movement Disorder Society Unified Parkinson's Disease Rating Scale~     (MDS-UPDRS). Both tools are non-invasive and clinically proven methods for measuring balance~     and motor function.~   "
111528|NCT02107625|"~     The purpose of this study is to to assess if the new diet with a low-FODMAP(Fermented Oligo-,~     Di-, Monosaccharides And Polyols) -content yields a milder symptom picture in IBS patients~     compared to traditionally dietary advice in IBS. The study also aim to investigate patients~     compliance to either dietary advices. Further, the investigators aim to find out if IBS~     patients with different symptoms are alleviated in different ways, to be able to~     individualize the dietary advices to result in a more optimal symptom relief in each patient~     in the future.~   "
111529|NCT02107612|"~     The purpose of this study was to evaluate the effect of a integrated system for inserting two~     splinted minimally-invasive implants, to retain mandibular over dentures, on the quality of~     life of edentulous patients.~   "
111530|NCT02107599|"~     This study will evaluate whether the addition of quantitation as an adjunct to visual~     interpretations significantly improves the accuracy of Amyvid scan interpretation.~   "
111531|NCT02107586|"~     The purpose of the study is to determine what the different outcomes are for biceps tenodesis~     and tenotomy in the treatment of the long head of the biceps pathology.~   "
111532|NCT02107573|"~     The purpose of the study is to compare the differences in outcome between the traditional~     rotator cuff repair surgery and rotator cuff repair with suprascapular nerve decompression~     surgery.~   "
111533|NCT02107560|"~     Cholangitis is a complication of biliary statsis. Bile juice is sterile when there is no~     obstruction, however, it can be infected with bacteria when there is a stasis or obstruction.~     After infection, cholangitis can be developed because of systematic endotoxemia or~     bacteremia. Though identification of bacteria is very important for selection of adequate~     antibiotics, treatment with empirical antibiotics is commonly performed when identification~     of bacteria is not possible.~      Identification of bacteria is usually done with blood or bile culture. In the previous~     studies, the same results from blood and bile were common in patients with cholangitis.~     However, the data of these studies were based on the bile juice which was aspirated by~     surgery. Considering that bile duct obstruction is usually treated with endoscopy or~     radiological intervention without surgery, it is necessary to collect data with endoscopic or~     radiologic intervention. In addition, the concordant rate of these two tests has not been~     reported according to severity of cholangitis. As a result, the necessities of bile and blood~     culture are not agreed among experts in this fields.~      Our hypothesis is that concordant rates of bile and blood culture are same in patients with~     each moderate or severe cholangitis. However, the concordant rates of bile and blood culture~     are different between patients with moderate and severe cholangitis. This study will assess~     the positive rates of blood and bile culture in patients with moderate or severe cholangitis,~     respectively and compare the results according to the different severity.~   "
111534|NCT02107547|"~     The purpose of the study is to determine which of the two alternative surgical interventions~     (biceps tenodesis or labrum repair surgery) is better in the treatment of Type 2 Superior~     Labrum Anterior and Posterior lesions.~   "
111535|NCT02107534|"~     Children with dyslexia show a variety of comorbid disorders like behavior and adaptive~     disorders, hyperkinetic and anxiety disorders. Raising and educating a child with dyslexia is~     a challenging task for parents. Studies show that parents of children with dyslexia suffer~     under depressive symptoms and higher parenting stress. In order to support the child's~     academic development many parents of children with dyslexia practice reading and writing more~     often and show controlling and maladaptive behavior. As a result learning motivation of the~     child decreases and later homework situations are influenced in a negative way.~      Consequently, it is necessary to provide parent training on appropriate behavior with~     homework and academic exercises, in order to raise parent's competences, reduce parenting~     stress and promote learning motivation of the child. In the German-speaking area there is a~     lack of elaborated and evaluated programs for parents of dyslexic children. Therefore, a~     group program that especially addresses the needs of these parents was devised. The study~     aims at evaluating the effects of the parent training. We hypothesize that the treatment~     reduces parenting stress and raises competences of the parents.~      Forty-one mothers of third graders with dyslexia were randomly assigned to the group-based~     parent training program (N=25) or a waiting list control group (N=16). Only children who~     performed in the normal range on the test measuring cognitive abilities (IQ > 70) and who~     scored below average in at least one test measuring reading or writing (T-Score < 40) were~     included. Children with significant deficits in hearing or vision, pervasive developmental~     disorder or genetic disorders were excluded. Data of children and their mothers were~     collected prior to intervention, directly after intervention and three months after~     intervention. For investigating training effects at all time points parenting stress and~     competences in supporting academic development, mastering homework situations and attachment~     to the child were measured. Parents of the waiting list control group had the possibility to~     take part in the parent training after the follow-up was completed.~      The intervention program consists of five two-hour sessions held biweekly. The training lasts~     about 10 weeks. It is designed for group sizes of three to ten persons. It follows a~     cognitive-behavioral approach. The training aims at knowledge transfer about dyslexia,~     raising parent's empathy for the child's difficulties in reading and writing, promoting~     parent's competencies and self-efficacy in handling dyslexia within the family context and~     during homework situations, sensitization for opportunities of integrating reading and~     writing into daily life and reduction of parental stress. The main topics covered are~     requirements and phases of acquisition of written language, the causes of dyslexia, helpful~     strategies for managing homework and exercises, facilitation of literacy in everyday life and~     dealing with dyslexia. Methods used are brief lectures, example cases, group discussions and~     practice, as well as homework tasks. Written handouts summarizing important topics are given~     at every session.~      A benefit of enrolling in the study is that parents get information concerning the academic~     development of their children. At the moment it is not sure whether parents profit from~     participating in the training because effects have not been investigated yet. The study takes~     place at the University of Heidelberg (Children's Hospital) and the Early Intervention Centre~     in Heidelberg. The study started in January 2012 and is expired to end in October 2014.~     Participants have been recruited two times, at the beginning of a school year. The timeline~     for every study flow was similar. Pretests took place in September and October; parent~     training started in December and lasted until February. Post-Test took place in February and~     March. Follow-Up measurements were realized from June to July. The study is funded by the~     Günter Reimann-Dubbers foundation of Heidelberg. The main contact for the study is Bettina~     Multhauf (M.Sc. Psych.), e-mail: fruehinterventionszentrum@googlemail.com~   "
111536|NCT02107521|"~     There is a lack of clarity regarding the justification to instruct the couple to shift from~     intracytoplasmic sperm injection (ICSI) to intracytoplasmic morphologically selected sperm~     injection (IMSI). In this study, we aim at evaluating the efficacy of IMSI in couples with~     previous implantation failure with ICSI.~   "
111537|NCT02107508|"~     Obesity is increasing rapidly all over the world not only in adults but also among children.~     As a modifiable component of total energy expenditure (TEE) ,the amount of energy expended~     during physical activity plays an important role in preventing weight gain. Decreased~     physical activity, coupled with an over-consumption of calories, lead to the change of body~     composition by storing energy as fat.Although several studies have simultaneously examined~     body composition with energy expenditure the independent roles of body composition with~     activity energy expenditure (AEE) are less firmly established. It's suspected shrewdly that~     energy expenditure is partly influenced by the body composition. The aim of the study is to~     examine the relation of AEE with body composition in a population of school-age children.~   "
111538|NCT02107495|"~     To establish the performance characteristics of the Samsung LABGEO IVD-A20 CHF Test in~     intended use settings, by comparing test results of the A20 CHF Test with results obtained~     from an FDA-cleared comparator assay.~   "
111539|NCT02107482|"~     The purpose of the study is to test the effect of a localized narrow band ultraviolet~     (NB-UVB) phototherapy compared to visible light that does not produce UVB on the clearance of~     psoriasis plaques and resolution of itching. Localized NB-UVB (Levia®) phototherapy device is~     cleared by the U.S Food and Drug Administration (FDA).~   "
111540|NCT02107469|"~     The purpose of the study is to determine whether phyllanthus niruri and sida cordifolia are~     effective in treatment of diabetic polyneuropathy compared to placebo. Also two different~     administration forms (extract capsules and crude herbs) are used to find out whether there~     are differences in efficiency and compliance.~   "
111667|NCT02105792|"~     This study will examine extreme responders to second- and third-line Type 2 diabetes therapy~     using a prospective approach, and patients with slow or fast diabetes progression using a~     retrospective approach.~   "
111542|NCT02107443|"~     This randomized clinical trial studies standardized geriatric assessment (GA) or usual care~     in improving communication and quality of life in older patients with advanced solid tumors~     or lymphoma and their caregivers. A GA measures the issues important to older patients,~     including function, psychological status, cognitive abilities, social support, and the impact~     of medical problems on quality of life. A GA may improve communication between patients and~     their doctors in addressing patient concerns. It is not yet known whether a standardized GA~     is more effective than usual care in improving communication and quality of life in older~     patients with solid tumors or lymphoma.~   "
111543|NCT02107430|"~     The purpose of this study is to determine whether DCVAC/PCa added after radical primary~     prostatectomy can improve PSA progression times within 5 years for patients with high risk~     localized Prostate Cancer.~   "
111544|NCT02107417|"~     This study aims to investigate the effects of Transcutaneous Electrical Nerve Stimulation~     (TENS) in reducing the symptoms of pain and numbness and improve the daily lives of cancer~     patients who have Chemotherapy-induced peripheral neuropathy (CIPN).~   "
111545|NCT02107404|"~     The purpose of this study is to determine whether DCVAC/PCa added after radical primary~     prostatectomy can improve PSA doubling times for patients with localized Prostate Cancer.~   "
111546|NCT02107391|"~     The purpose of this study is to determine whether DCVAC/PCa added onto hormone therapy can~     improve PSA progression times for patients with Metastatic Prostate Cancer.~   "
111547|NCT02107378|"~     The purpose of this study is to determine whether DCVAC/OvCa added to chemotherapy may result~     in prolongation of Overall Survival (OS).~   "
111548|NCT02107365|"~     Success rates, after retreatment with Peg-Interferon/Ribavirin bitherapy, in patients~     infected with HCV (hepatitis C virus) genotype 4 and non-responders to a first standard~     treatment, are disappointing. The association of Asunaprevir and Daclatasvir in combination~     with the standard-of-care bitherapy has been shown to increase the efficacy of the treatment~     in non-responders genotype 1-infected patients.~      Given the absence of current solutions and urgent therapeutic needs for HCV genotype~     4-infected patients previously treated with pegylated Interferon/Ribavirin, this pilot study~     aims to evaluate the efficacy and safety of a quadritherapy associating Asunaprevir,~     Daclatasvir, pegylated Interferon alpha-2a and Ribavirin, in this very difficult to treat~     population.~      60 subjects will be enrolled.~      The primary endpoint will be the rate of sustained virological response (SVR), defined by an~     undetectable HCV RNA, at Week 36 (12 weeks after the end of a 24 weeks quadritherapy).~   "
111549|NCT02107352|"~     The main aim of this research is to investigate whether the use of cognitive event-related~     potentials is an interesting way to identify subgroups of alcoholic patients displaying~     specific clinical symptoms and cognitive disturbances in order to help clinicians to adapt~     the pharmaceutical approach to the specific needs of the patient.~      Nowadays, a fundamental question remains: How can investigators identify among alcoholic~     patients who are likely to benefit from the use of naltrexone, acamprosate or baclofen, and~     those who are not? The goal of this application is to identify subgroups of alcoholic~     patients displaying specific clinical symptoms and cognitive disturbances linked to~     consistent biological markers. Investigators propose that this might help clinicians improve~     their treatment of alcoholic patients by focusing therapy on individual cognitive~     disturbances, and by adapting pharmaceutical approaches to the identified brain~     pathophysiology. In other words, investigators suggest that specifying the cognitive profile~     of each individual patient may help clinicians in their choice of a suitable drug program.~      To reach this aim, investigators suggest that a joined investigation of early (P100) and late~     (P300) brain event-related potentials (ERP) components may help create subgroups of alcoholic~     patients with homogenous cognitive deficits, and that this ''classification'' might help~     optimize drug treatment. More precisely, investigators suggest that relapse in chronic~     alcoholism is partly due to (1) the preferential attentional allocation to alcohol-related~     information (e.g. the sight of a bottle of wine). As the P100 component has already been~     shown to be enhanced by motivationally relevant stimuli, investigators think that this~     component is well-suited for this purpose; and (2) the impairment of the inhibitory control,~     which is necessary to suppress an inappropriate prepotent response. The Go/No-Go task is a~     simple procedure, which has already proven to be highly reliable to evidence a deficit in~     inhibitory control processing in alcoholics, indexed by a No-Go P3 of decreased amplitude and~     less anterior topography. In summary, investigators have two simple experimental procedures,~     an oddball task and a Go/No-Go task, which can be easily carried out in clinical settings,~     and which can provide interesting data concerning, respectively, the existence of an implicit~     attentional bias towards alcohol-cues and the deficit of inhibitory control towards a~     prepotent response, through the observation of well-known and well-described cognitive ERP~     components, i.e. the P100 and P3b components. The main goal of this project will be to test~     the effect of different drug medications on both attentional (P100) and inhibitory (P300)~     deficits observable in alcoholic patients.~   "
111550|NCT02107339|"~     Patients undergoing major spinal surgery continue to experience moderate-to-severe pain~     during the first 2-3 days following the operative procedure. Pain complicates the recovery~     process, despite the routine practice of using potent opioid analgesics. The primary reason~     that pain is poorly controlled in patients undergoing major surgery is that most~     commonly-used opioids only produce analgesia for 2-4 hours. The intermittent use of these~     drugs results in periods of time when a patient will experience discomfort (at which time a~     nurse administers more drug or the button on a patient-controlled analgesic (PCA) system is~     pressed to deliver more medication). The use of a long-acting opioid may be advantageous in~     the perioperative setting. Methadone is an opioid that has a median duration of analgesia of~     24-36 hours. Therefore, a single dose administered in the operating room may reduce the need~     for pain medication and improve pain control for the first few postoperative days. The aim of~     this randomized clinical trial is to examine the effect of methadone (compared to~     hydromorphone) on postoperative pain management in patients undergoing major spine surgery~   "
111551|NCT02107326|"~     The purpose of this study is to evaluate the impact of a software for smartphones and tablets~     on type 1 diabetes control and quality of life~   "
111552|NCT02107313|"~     This study is designed to determine the pharmacokinetic (PK) profile of a single oral dose of~     PBT2 administered to healthy volunteers in the presence and absence of food.~   "
111553|NCT02107300|"~     To assess whether the daily use of NeutraSal will prevent or reduce dry mouth in patients~     undergoing CPAP therapy for OSAS and improve CPAP compliance~   "
111554|NCT02107287|"~     Considering the promising results with hypofractionated in low and intermediate risk prostate~     cancer, our proposal is to translate this experience to patients with high risk prostate~     cancer. Patients with high risk disease would receive hypofractionated RT to the prostate and~     to the external and internal iliac lymph nodes using IMRT plus long-term hormonal therapy.~     The objective of the study is to show that long term grade>2 late toxicity is acceptable and~     similar to published data using hypofractionated technique in the prostate only.~   "
111555|NCT02107274|"~     Bronchiectasis is a chronic lung condition characterised primarily by dilatation of the~     airways. Only a small number of clinical studies have been conducted investigating the use of~     macrolides to treat non-cystic fibrosis bronchiectasis. The purpose of this study is to~     determine the efficacy of 12 weeks treatment with azithromycin in adult patients with~     non-cystic fibrosis bronchiectasis.~   "
111556|NCT02107261|"~     The investigational drug being studied in this protocol is Incobotulinumtoxin A (Xeomin®).~     Botulinum toxin (BoNT) prevents the release of the acetylcholine from peripheral nerves,~     inhibiting muscle contractions. BoNT is effective in relaxing overactive muscles. In~     musician's dystonia, the ability to reduce abnormally overactive muscles in the hand can be~     critical for the musical professional to continue his or her career. With the use of~     EMG/electrical stimulation and/or ultrasound guidance, the injector can precisely localize~     the individual muscles that are affected in this condition with great accuracy. Prior studies~     have shown that BoNT injections produce beneficial effects in forearm muscles, and less~     effect in shoulder or proximal arm muscles.~      Possible risks in treating patients with BoNT include excessive weakness of the injected~     muscles. The drug may also affect non-targeted muscles. However these risks will be minimized~     during the screening period by carefully targeting the affected muscles and by administering~     low doses of BoNT. Small booster doses may be given at follow up visit (2, 4, 14 and 16-weeks~     after the primary injection date) if the initial injection was insufficient to produce~     sufficient efficacy in relief of the focal dystonia and did not produce excess weakness of~     the targeted muscle.~   "
111557|NCT02107248|"~     Aim of the current study is to test the non-inferiority hypothesis of differences in early~     hip dislocation between a group of patients who will be restricted to sleep in supine~     position and a group without restricted sleeping position during the first eight weeks after~     a total hip replacement following a posterolateral surgical approach~   "
111558|NCT02107235|"~     The working hypothesis is that oral rigosertib treatment when added to platinum-based~     Chemoradiotherapy (CRT) will improve progression-free survival for first-line patients with~     intermediate- or high-risk human papillomavirus negative positive (HPV (+)) Head and Neck~     Squamous Cell Carcinoma. This study will determine the highest safe dose of oral rigosertib~     that can be used with cisplatin and CRT. This study will also record any side effects that~     may occur and measure tumor sizes and how long patients live.~   "
111559|NCT02107222|"~     A Multicenter, Randomized, Controlled Trial to Determine Safety and Efficacy of Pump Assisted~     Lung Protection (PALP™) for Low Flow Carbon Dioxide (CO2) Removal in Conjunction with~     Liberation from Mechanical Ventilation Compared to Mechanical Ventilation Alone in Patients~     with COPD Exacerbation and Respiratory Failure~   "
111560|NCT02107209|"~     The clinical utility of bronchoscopic methods for achieving lung volume reduction has been~     evaluated in patients with advanced emphysema because these procedures are uniformly safer~     than surgical volume reduction. These include one-way valves, or bronchial occlusive devices~     to collapse emphysematous regions of lung and bronchial fenestration with bypass stents to~     improve expiratory flow, wire coils implants that compress the airway and thermal vapor~     ablation that causes an acute injury with subsequent fibrosis and reductions in volume.~   "
111561|NCT02107196|"~     Irritable Bowel Syndrome with diarrhoea (IBS-D) is a functional gastrointestinal disorder~     characterised by chronic or recurrent abdominal pain or discomfort and diarrhoea. This trial~     aims at the evaluation of the efficacy and safety of oral ibodutant 10 mg once daily as~     compared to placebo in women with IBS-D over a 12-week treatment period.~   "
111562|NCT02107183|"~     The purpose of this study is to determine whether, as compared with the Venturi mask, a~     nasal, high-flow oxygenation device (Optiflow) may reduce the extubation failure rate in~     patients needing oxygen therapy after extubation.~   "
111563|NCT02107170|"~     Endovascular repair of aortic aneurysm and endovascular treatment of arteriosclerosis~     obliterans of lower extremities are two kinds of common surgeries in the investigators'~     hospital. The effects of anesthetic agents on postoperative outcome, especially cognitive~     function, are not clear. In this study investigators propose to measure postoperative~     cognitive function and other outcome of patients who are undergoing these two kinds of~     surgeries, and try to identify whether there is an association between different kinds of~     anesthetics and postoperative outcome. Investigators will also observe whether changes in~     plasma levels of VEGF, TGF-1, TNF-α, IL-1β, and IL-6, are associated with postoperative~     delirium or cognitive change.~   "
111564|NCT02107157|"~     The purpose of this study is to assess treatment of facial rejuvenation using the standard~     hand piece and a Lens Array for the 755nm Alexandrite laser.~   "
111565|NCT02107144|"~     The study should enrol 50 patients with stable coronary artery disease scheduled for elective~     percutaneous coronary intervention of single, de novo lesion of native coronary artery.~     Patients will be randomized to orally given trimetazidine on top of standard medical therapy~     for stable coronary artery disease versus standard therapy only. The randomization will begin~     48 hrs before intervention. Index of microcirculatory resistance (IMR) will be measured by~     thermodilution method using coronary pressure and temperature wire before and after stent~     implantation. Echocardiography will be performed before intervention and within 30 minutes~     after intervention. Patients will be followed clinically for a period of one year.~   "
111566|NCT02107131|"~     Performance assessment testing may be a useful tool to evaluate the impact of ranibizumab on~     day-to-day visual function in patients with Diabetic Macular Edema (DME).~   "
111567|NCT02107118|"~     Men who present with erectile dysfunction as defined as an IIEF (International Index of~     Erectile Function) score less than 21 will be evaluated for risk factors for cardiovascular~     disease (CVD). This is a single-blind study. Subjects will be randomized in a 2:1 fashion for~     treatment (ARM 1) versus placebo (ARM 2). Adipose tissue (fat) will be harvested from all~     patients and stem cells will be cultured. For those patients in the placebo arm the stem~     cells will be frozen for later use after one year when the patients cross over into the~     treatment arm.~   "
111568|NCT02107105|"~     The goal of this study is to learn about quality of life in patients who have or have had~     rectal cancer.~   "
111569|NCT02107092|"~     Subjects who completed the Double-blind Randomized Maintenance Phase (DBRMP) Study Day 29~     visit in ZS-004 (NCT 02088073) and have an i-STAT potassium value that is 3.5 to 6.2 mmol/l~     inclusive or who discontinued during ZS-004 due to hypo- or hyperkalemia in the DBRMP and~     have a mean i-STAT potassium value from two consecutive measurements at 0 and 60 minutes on~     Acute Phase Day 1/Maintenance Phase Day 1 that is 3.5 to 6.2 mmol/l inclusive may have the~     option to participate in ZS-004E (NCT 021070920). Subjects who discontinued from study ZS-004~     due to any other reasons (e.g. adverse events, poor compliance, investigator decision) will~     not be entered into study ZS-004E. All subjects who continue into the extension study must~     begin dosing within two (2) days after the last dose of investigational product in ZS-004.~   "
111570|NCT02107079|"~     The circadian rhythm, the sleep-wake cycle, is mainly regulated by melatonin. The synthesis~     of melatonin is stimulated by the absence of light, leading to peak serum levels before~     bedtime. In humans, this endogenous signaling neurohormone induces sleep. Exogenous~     melatonin can be beneficial in different sleep disturbances including delayed sleep phase~     insomnia, melatonin- deficiency-related insomnia (especially in elderly) and shift work sleep~     disorder. Melatonin is known for its low and variable bioavailability in humans due to a high~     first pass effect and variable pharmacokinetics and short half-life. In order to prevent~     exposure of patients with unnecessary high dosages of melatonin and in order to achieve a~     short Tmax and high bio-availability of melatonin, a proper formulation needs to be defined.~     This study, a three-phased cross-over study, aims to define a proper formulation for oral and~     oromucosal melatonin for the treatment of insomnia by investigating the Tmax and relative~     bioavailability derived from melatonin levels in salivary samples of healthy volunteers after~     administration of melatonin in different formulations: 2,5mg melatonin immediate release~     capsule (produced by Apotheek UMCU), 1mg melatonin immediate release tablet (produced by~     Tiofarma), low-dose 0.1mg melatonin original Sleepzz tablet (produced by Vemedia~     Manufacturing BV).~   "
111571|NCT02107066|"~     Despite an increase in longevity, surviving ovarian cancer often brings an array of~     unpleasant side effects and compromises in QOL. Our proposed trial will be the first study to~     test whether exercise compared with attention control has a beneficial impact on quality of~     life, fitness and surrogate markers of ovarian cancer. Our trial could suggest a unique and~     important role for exercise in ovarian cancer care given that physical and functional aspects~     of QOL are often the most compromised in ovarian cancer patients.~   "
111572|NCT02107053|"~     Atherosclerosis and its related cardiovascular morbidity and mortality, underlie many chronic~     diseases. Most atherosclerotic patients have multiple cardiovascular risk factors, which~     potentiate each other, causing a huge burden on health systems. In order to improve the~     understanding and treatment options of atherosclerosis, it is necessary to identify common~     basic pathways in its pathogenesis. Oxidative Stress (OS) has a major role in the~     pathogenesis of atherosclerosis; however, good biomarkers to determine OS are still missing.~   "
111573|NCT02107027|"~     The aim of this study is to compare two type of ablation catheters for pulmonary veins~     isolation (PVI) in subjects with atrial fibrillation.~      Currently, two technologies of irrigated ablation catheters are available for PVI.~      One of the two, the conventional catheter is widely used for atrial fibrillation (AF)~     treatment but has not been specifically created for pulmonary veins isolation, therefore,~     point by point encircling lesions are cumbersome and time consuming.~      The second is a new ablation catheter with a circular shape provided with 10 irrigated~     electrodes designed to create encircling lesions, necessary to obtain pulmonary veins~     isolation, could allow an easier and faster isolation compared to the conventional way.~      These two types of catheters have never been compared for atrial fibrillation. If one of the~     two catheters appears to be more efficient or causes fewer complications, the use of this~     catheter could be favored to conduct AF ablation.~   "
111574|NCT02107014|"~     We have found that low dose naltrexone (LDN) can substantially reduce pain associated with~     fibromyalgia syndrome. We believe LDN may work via novel anti-inflammatory channels. The~     purpose of this study is to determine if LDN lowers inflammatory markers in individuals with~     fibromyalgia.~   "
111575|NCT02107001|"~     Chest pain is an alarming symptom and one of the most frequent causes of access to the~     Emergency Departement. Although chest X-ray remains an essential step in the diagnostic~     process, several studies showed numerous limitations of radiography which frequently is~     inconclusive. Ultrasonography is a non-radiating imaging technique. Albeit a wide use of~     ultrasound, the utilization of ultrasound in the study of the lung has only recently been~     introduced in the clinical practice. Several studies proved that lung ultrasound is useful in~     the diagnosis of lung consolidation in community acquired pneumonia. Nowadays, ultrasound is~     not routinely used in the presence of chest pain. Our hypothesis based on clinical experience~     is that, in patients with pleuritic chest pain, lung ultrasound is very sensitive in~     detecting pneumonia and other lung diseases (such as pneumothorax) thus performing better~     than radiography. The primary aim of this study is to verify, in patients affected by~     pleuritic chest pain, the accuracy of lung ultrasound compared to chest-X-ray. The secondary~     aim is to evaluate the accuracy of lung ultrasound consolidations in distinguishing lung~     consolidation in pneumonia, atelectasis, pulmonary infarction, or tumors.~   "
111576|NCT02106988|"~     The goal of this clinical research study is to learn if radiation therapy and chemotherapy~     can help control Stage 1 and/or 2 NK cell lymphoma. The safety of the radiation and~     chemotherapy combination will also be studied.~      This is an investigational study. Radiation and chemotherapy are FDA approved and~     commercially available for patients with Stage 1 and/or 2 NK cell lymphoma. The combination~     of these therapies given at the same time is investigational.~      Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.~   "
111577|NCT02106975|"~     Hypothesis 1A: Vitamin C infusion will significantly attenuate sepsis-induced systemic organ~     failure as measured by Sequential Organ Failure Assessment (SOFA) score,~      Hypothesis 1B: Vitamin C infusion will attenuate sepsis-induced lung injury as assessed by~     the oxygenation index and the VE40~      Hypothesis 1C: Vitamin C infusion will attenuate biomarkers of inflammation (C-Reactive~     Protein, Procalcitonin), vascular injury (Thrombomodulin, Angiopoietin-2), alveolar~     epithelial injury (Receptor for Advanced Glycation Products), while inducing the onset of a~     fibrinolytic state (Tissue Factor Pathway Inhibitor).~   "
111578|NCT02106962|"~     This study will investigate how the use of Tranexamic acid and Bacitracin applied to the~     bleeding site after the hemodialysis fistula needle is removed will affect Time to Clot and~     Infection Rate~   "
111579|NCT02106949|"~     The study wants to prove that SMS monitoring reduced the number of suicide attempts in six~     months according to the beginning of its implementation in the group of the patients~     benefiting SMS compared with the group of patients benefiting from the usual care.~   "
111763|NCT02104544|"~     This is a multi-center, cross-sectional, non-interventional, observational study——an~     investigation carried out in 816 pregnant (pregnant week 17±2 group and pregnant week 39±2~     group; 408 cases in each group) and 408 lactating women (post-natal lactation day 42±7 group)~     from a total of 4 sites in 3 typical areas (1 coastal regions, 2 inland regions and 1 lake~     regions) in China to study the correlation between DHA intake and DHA concentrations in blood~     and breast milk.~   "
111580|NCT02106936|"~     Background:~      - Focal hand dystonia (FHD) causes muscles to contract, leading to abnormal movements or~     postures. Musicians, writers, and athletes often get it. Researchers want to study how~     patients with this condition learn, a process of the brain that depends on a property called~     plasticity.~      Objective:~      - To study brain plasticity in people with FHD.~      Eligibility:~        -  Right-handed adults 18 years and older with FHD.~        -  Healthy, right-handed adult volunteers.~      Design:~        -  Participants will be screened with medical history, physical exam, pregnancy test, and~          questionnaire about their right-handedness.~        -  Participants will have 2 study visits on 2 different days.~        -  Participants will sit in a chair and have up to 30 Transcranial Magnetic Stimulation~          (TMS) pulses on the left side of the head. A brief electrical current passes through a~          wire coil on the scalp. They will hear a click and may feel a pulling on the skin or~          muscle twitches. They may have to keep their eyes open and remain alert, tense certain~          muscles, or perform simple finger movements.~        -  Forty more pulses, with 10 seconds between, will be given on the left side of the head.~          Some will be small, some big.~        -  Researchers will measure muscle response through small electrodes taped to the right~          hand.~        -  A cloth cap will be put on the participant s head. Researchers will write on tape on the~          cap.~        -  Participants will have the r-PAS. An electrical stimulator will be placed on the nerve~          at the right wrist. Repeated magnetic pulses will be delivered in trains or short bursts~          together with electrical stimulation of nerve. Participants will receive up to 840~          pulses.~        -  Participants will be contacted after a few days for a follow-up check.~   "
111581|NCT02106923|"~     The purpose of this trial is to demonstrate the relative bioavailability of 2 newly developed~     fixed dose combinations (FDC) tablets containing empagliflozin & metformin XR and the single~     tablets of empagliflozin and metformin XR when administered singularly~   "
111582|NCT02106910|"~     Subjects presenting to UNC Hospitals for routine endoscopic surveillance examinations for~     current Barrett's Esophagus (BE) or after successful radiofrequency ablation (RFA) of~     dysplastic Barrett's Esophagus (BE) will be offered enrollment in the study. After informed~     consent, and the same day as the endoscopic procedure, the subject will undergo~     administration of the Cytosponge assay. The patient will then undergo routine endoscopic~     surveillance, using a standard Seattle biopsy surveillance protocol. The Cytosponge will be~     placed in fixative and shipped to the Fitzgerald laboratory at the University of Cambridge~     for processing according to their established protocols. Tissue biopsies will undergo~     standard processing and H&E staining, with assessment by expert gastrointestinal pathologists~     at UNC. The primary outcome variables will be sensitivity and specificity of the novel assay,~     compared against the gold standard of the presence of recurrent BE as detected by upper~     endoscopy with biopsies. Secondary outcomes include acceptability of the nonendoscopic assay~     to the patient (assessed by a standardized tool, the Impact of Events Scale, as well as a~     visual analogue scale), and likelihood of assay positivity as a function of amount of~     residual disease (as measured by Prague criteria).~   "
111583|NCT02106897|"~     The primary objective of Parts 1 and 2 is to evaluate the safety and tolerability of either~     single-ascending intravenous (IV) doses or a single subcutaneous (SC) dose of BIIB059 in~     healthy volunteers (HV), and a single IV dose in participants with Systemic Lupus~     Erythematosus (SLE). The primary objective of Part 3 is to evaluate the safety and~     tolerability of multiple SC doses of BIIB059 in healthy volunteers and in participants with~     SLE.~      Secondary objectives of Parts 1 and 2 are as follows: To estimate the PK parameters of~     single-ascending IV doses of BIIB059 in healthy volunteers and a single IV dose of BIIB059 in~     participants with SLE; To estimate the PK parameters and bioavailability (F) of a single SC~     dose of BIIB059 in healthy volunteers; To evaluate the immunogenicity of BIIB059 administered~     to healthy volunteers and participants with SLE. Secondary objectives of Part 3 are as~     follows: To estimate the PK parameters of multiple SC doses of BIIB059 in healthy volunteers~     and in participants with SLE; To evaluate the immunogenicity of BIIB059 administered SC to~     healthy volunteers and participants with SLE.~   "
111584|NCT02106884|"~     This is a quality of life study done in the context of a randomized trial in pancreatic~     cancer. Patients with locally advanced or metastatic pancreatic adenocarcinoma receive either~     the combination of nab-paclitaxel gemcitabine or the existing standard gemcitabine alone~     treatment.The combination regimen of nab-paclitaxel and gemcitabine administered in patients~     with locally advanced or metastatic pancreatic cancer in a first line setting showed improved~     efficacy with acceptable toxicity. The current study design allows patients in standard~     treatment to receive the combination treatment at tumour progression.~      The proposed study will explore the impact of treatment on the quality of life and compare~     the times to definitive deterioration of the quality of life scores using the validated EORTC~     QLQ-C30. Efficacy and safety secondary endpoints are to be reported in a descriptive manner.~      Molecular studies will be performed on blood and tissue samples.~   "
111585|NCT02106871|"~     Investigation of the effects of daily sildenafil on patients with pancreatic or~     cholangiocarcinoma cancer undergoing treatment.~   "
111586|NCT02106858|"~     To investigate and collect post-marketing data on the safety of Stivarga in real world~     practice in its registered indication(s) as required by Health Authority.~   "
111587|NCT02106845|"~     Evaluate the effect of regorafenib on the pharmacokinetics of digoxin (P-gp substrate :~     P-glycoprotein) and rosuvastatin (BCRP substrate: Breast cancer resistant protein) by~     comparing their Area under time curve (AUC(0-24)) and maximum drug concentration (Cmax) on~     Day -7 and Cycle 1 or Cycle 2 Day 15 of regorafenib in cancer patients~   "
111588|NCT02106832|"~     The purpose of this study is to evaluate if the time to first pulmonary exacerbation of~     bronchiectasis or its frequency can be prolonged by inhalation of ciprofloxacin for 28 days~     every other 28 days or for 14 days every other 14 days over 48 weeks.~   "
111668|NCT02105779|"~     The purpose of this study is to drive an optimal response to neuroplasticity-based cognitive~     remediation in schizophrenia in order to maximize treatment response. The investigators will~     investigate factors that have generally been ignored in prior computer-based cognitive~     remediation programs—those related to social cognition-- and will delineate their~     relationship to motivation, functional outcome, and the neural substrates of reward~     anticipation and emotion processing. Current research indicates that, unless the~     investigators fully understand and harness these factors, the investigators will not achieve~     meaningful treatment gains for individuals with schizophrenia.~   "
111589|NCT02106819|"~     The cerebellum has been linked to cognitive and emotional functions and there is increasing~     evidence that damage to posterior portions of the cerebellum can result in frontal-executive,~     visuospatial, and verbal deficits, including dysprosodia, and affective changes including~     blunting of affect or disinhibited and inappropriate behavior. Based on preliminary clinical~     observations and tests performed in the investigator's clinic, disorders of emotional~     communication may also be associated with cerebellar dysfunction. Emotional communication~     includes the production and comprehension of facial and prosodic expressions and is critical~     to maintaining positive and supportive relationships. Deficits in emotional communication can~     have devastating effects on relationships and on quality of life for those affected. Although~     deficits in affect and prosody have been reported in association with posterior cerebellar~     disorders, there are currently no studies systematically investigating emotional~     communication in individuals with cerebellar dysfunction. It is known that the cerebellum has~     strong connections with the cerebral cortex, especially the frontal lobes, and that cortical~     damage from stroke or neurodegenerative disease can result in disorders of emotional~     communication. Impairments in the integrity of cerebellar-cerebral networks from cerebellar~     disease may produce similar deficits in emotional communication. The purpose of this study is~     to systematically investigate and describe deficits in emotional communication in a series of~     patients with cerebellar disease. Participants will be individuals diagnosed with posterior~     cerebellar degeneration or damage from a non-hemorrhagic infarction, and age-matched~     neurologically healthy controls. Assessment will include a battery of tests of~     neuropsychological function as well as tests of emotional communication. Comprehension of~     emotional facial and prosodic expressions will be assessed as well as production of emotional~     communication. The expected outcomes will be to identify and describe deficits in production~     and comprehension of emotional prosodic and facial expressions and to describe the~     relationship between deficits in emotional communication and cerebellar atrophy with magnetic~     resonance imaging imaging (MRI) using voxel based morphometry (VBM).~   "
111590|NCT02106806|"~     Objective: To determine the oxidative stress during cycles of chemotherapy in patients after~     surgery for colorectal cancer, with or without oral zinc supplementation. Subjects: Twenty~     four adults from both genders participated in this study. All patients underwent stage II,~     III or IV colorectal cancer surgical resection and were starting chemotherapy in HCFMRP- USP.~     Patients were randomized into two groups. The first one (QTx-Zn Group, n=10) received 70 mg/d~     of zinc orally and the second one received placebo (QTx-Placebo Group, n=14) for 16 weeks.~     The study also included 30 healthy volunteers matched for age, gender and socioeconomic~     status, who received 70 mg/d of zinc supplement (Control-Zn Group, n=21) or placebo~     (Control-Placebo Group, n=9) for 16 weeks. Methods: The questionnaires about dietary intake~     (semiquantitative food frequency and food record), fatigue and quality of life (FACIT-F) and~     questionnaires that assess the side effects of chemotherapy (CTCAE) were evaluated.~     Anthropometry and bioelectrical impedance measurements were made. Blood collection was~     performed before the 1st, 2nd, 3rd and 4th cycles of chemotherapy (median duration of 21 days~     among cicles). Routine laboratory tests, vitamin E and markers anti and pro-oxidants (MDA,~     SOD, GPx and isoprostane) ere determined. The control group underwent the same procedures,~     except for chemotherapy. A longitudinal linear mixed effects model was adjusted for each of~     the variables of interest. The models were fitted using PROC MIXED of SAS version 9 (SAS,~     CARY, NC, USA). To analyze the association of categorical variables in the different items of~     the CTCAE, the investigators used the Fisher exact test. Results: The oral zinc~     supplementation was sufficient to increase plasma levels of zinc and did not alter food~     intake, body composition and routine laboratory evaluation of patients undergoing~     chemotherapy for colorectal cancer. Compared with QTx-Placebo Group, QTx-Zn Group showed~     lower prevalence of complaint on the salivary gland (17 vs. 75%). Fatigue (43 ± 6 vs. 36 ±~     13) and quality of life (126 ± 160 vs. 116 ± 27) has become worst in the period between the~     1st and 4th cycles of QTx in QTx-Placebo Group. When compared with QTx-Placebo Group, QTx-Zn~     Group had higher values of SOD before the 1st (2297 ± 503 vs. 1604 ± 352 USOD/g Hb), 2nd~     (2037 ± 515 vs. 1712 ± 417 USOD/g Hb) and 4th (2202 ± 323 vs. 1821 ± 360 USOD/g Hb) cycles of~     QTx. GPx values decreased in QTx-Zn Group before the 3rd cycle of QTx (48.5 ± 7.0 vs. 54.3 ±~     2.3 mol NADPH/min/gHb). Conclusions: These data suggest that zinc supplementation reduces~     complaints related to the change in salivary gland, preserving the quality of life and~     preventing the worsening of fatigue. The increase in SOD can be attributed to zinc~     supplementation per se, whereas this mineral is a cofactor that endogenous antioxidant~     enzyme. The highest activity of SOD increases the production of H2O2, whose detoxification~     involves the participation of GPx, justifying its reduction. There were no changes in plasma~     levels of vitamin E, MDA and isoprostane during the study period. Considering the values of~     MDA and isoprostane, the data indicate that regardless of zinc supplementation, the lipid~     peroxidation of the cell membrane was unchanged during chemotherapy.~   "
111591|NCT02106793|"~     Primary objective~        -  To compare the incidence of postoperative nasal synerchia between Mitomicin C and~          placebo in patients at 6 months after endoscopic sinus surgery~        -  To validate the Thai version of disease-specific quality of life tool SNOT-22~      Secondary objectives~        -  To compare the clinical signs and symptoms of CRS in patients who receive Mitomicin C~          with those who receive placebo~        -  To compare the disease-specific quality of life in patients who receive Mitomicin C with~          those who receive placebo~        -  To compare the side effects of Mitomicin C versus placebo~   "
111592|NCT02106780|"~     Subjects receive a single oral dose of radioactive ASP1707 on Day 1. Blood, plasma, urine and~     feces samples are collected for analysis of 14C-radioactivity and ASP1707. Metabolites are~     collected until at least 144 hours after dosing.~   "
111593|NCT02106767|"~     The effect of transporter inhibition by rifampin on the pharmacokinetics of rosuvastatin will~     be studied in clinical trial in White and Asian healthy volunteers.~   "
111594|NCT02106754|"~     This proposal is in response to RFA-AA-12-008, Evaluation of NIAAA's Alcohol Screening Guide~     for Children and Adolescents. Of particular interest to the agency are evaluation of the~     Screener in clinical and/or other settings to predict alcohol-related consequences including~     use disorder; its use as an initial screen for drug use, cigarette smoking, conduct disorder,~     and unprotected sex; and its performance in making predictions concurrently and~     prospectively. This proposal targets these areas of interest. In addition, the investigators~     will study implementation of the Brief Intervention (BI) associated with the Screener. There~     is a great need for both screening and BI in juvenile probation settings as many of these~     youths have great need but are underserved.Many probation departments are turning to BI to~     work with probationers and parolees. Screening and BI has demonstrated efficacy in these~     settings, and yet no randomized control trials have been conducted to evaluate effectiveness~     in juvenile probation settings. Probation Officers (POs; n=40) are randomized to Screener~     (S), Screener+BI (SBI), or coaching (CSBI). Youths (N=1000) are randomized to 1 of these 3~     conditions, and all receive usual services (US). US consist of regular check-in with PO and~     access to referral services as needed (counseling, academic tutoring, etc.). Research~     staffers conduct in-depth assessment at baseline, 6- and 12- months. Sensitivity,~     specificity, and positive and negative predictive powers (SN, SP, PP, NP) are calculated to~     predict alcohol risk and consequences, as well as other risky behaviors concurrently and~     prospectively across age-groups. A 1-way design (S vs SBI vs CSBI) will be used to determine~     whether SBI and CSBI enhance youth services-use and reduce risks (e.g., alcohol use, risky~     sex). We examine moderators of outcomes (youth age, PO characteristics) and whether coaching~     (an important consideration in implementation science) in use of BI improves outcomes. This~     study will be the first randomized controlled trial evaluating the effectiveness of SBI in a~     juvenile probation setting.~   "
111595|NCT02106741|"~     The purpose of this study is to compare two kinds of self-administered acupressure~     (relaxation acupressure and stimulating acupressure) to usual care for management of fatigue~     and pain in low back pain patients.~      Hypothesis: Self-administered relaxation acupressure will result in improvements in fatigue~     and sleep quality, pain, and physical function compared to stimulating acupressure and usual~     care.~   "
111596|NCT02106728|"~     Eating Disorders are a debilitating and serious mental illness. This illness is associated~     with medical complications, psychological and social impairment. Families of people with an~     eating disorder also report that they lack resources and have many unmet needs. Families~     often have insufficient information regarding the eating disorder, available treatment~     options and strategies for supporting the person with the illness. The purpose of this study~     is to evaluate the effectiveness of two different family interventions for people with eating~     disorders and their family members (parents or partners) receiving treatment either in the~     inpatient or day treatment Eating Disorder Program at the Toronto General Hospital,~     University Health Network. Family supportive counseling consists of people with eating~     disorders and their family members meeting with a family therapist. Multi-family group~     therapy involves eight to ten families who meet as a group with two therapists. The~     investigators are conducting a study to assess the differences between these two different~     family interventions. This study will help us identify who benefits the most from~     participating in family supportive counseling or multi-family therapy. The investigators are~     also evaluating which intervention is more effective at helping the person with the eating~     disorder overcome their illness while helping their family members learn how to support the~     recovery process. Both family therapy interventions are delivered by experienced family~     therapy clinicians who work in either the Inpatient or Day Treatment Eating Disorder Program~     at Toronto General Hospital.~   "
111597|NCT02106715|"~     The purpose of this study is to investigate the prevalence of overload injuries to road~     cyclists in Sweden, and if it 's possible to prevent low back pain by a simple exercise~     program for two months of training .~   "
111598|NCT02106702|"~     Each year, there are over 600 unduplicated HIV-infected persons incarcerated in the San~     Francisco jail. Two thirds of those released with HIV-focused discharge planning are~     reincarcerated within one year. More than half of HIV-infected jail inmates are diagnosed~     with mental health conditions severe enough to require medication and a similar proportion~     report substance use disorders at the time of detention. While some community-based services~     exist, there remains a critical need to improve linkages to care and adherence to care plans~     for HIV-infected adults as they move between community and jail. The Navigator Project is a~     five-year randomized study that will test the effectiveness of an intensive enhanced case~     management intervention to reduce sex and drug-related HIV transmission risk; increase HIV~     medication adherence; reduce drug dependence; and reduce reincarceration.~   "
111678|NCT02105649|"~     It will be hypothesized that strengthening the calf muscles will improve standing efficiency~     in children with spastic diplegia.~   "
111599|NCT02106689|"~     The daily injections required for superovulation, a fertility treatment using injections to~     stimulate a women's ovaries to produce multiple eggs, can be an anxiety provoking process for~     many women and a deterrent to treatment. Alternative needle-free injection systems have been~     developed with the intention of reducing needle phobia and pain, while providing similar~     results. However, these needle-free systems are not yet being widely used for women with~     infertility.~      The purpose of this study is to assess whether the pain and apprehension patients often~     associate with needles and injections, can be alleviated by using a new, Health Canada~     approved, needle-free system. The purpose of the current study is to assess whether patient~     satisfaction is improved in patients using a needle free injection system for the daily self~     injections required for superovulation induction as compared to patients using the standard~     needle and syringe.~   "
111600|NCT02106676|"~     The aim of this study is to determine maternal androgen metabolism during pregnancy and the~     impact of androgen disorders on mothers and infants.~   "
111601|NCT02106663|"~     This is a PI-initiated study that aims to evaluate the efficacy of two different methods of~     paroxysmal atrial fibrillation (PAF) ablation. There are currently two strategies for PAF~     ablation that are routinely performed by electrophysiology clinicians: (1) circumferential~     pulmonary vein ablation (CPVA) and (2) segmental pulmonary vein isolation (SPVI). However, it~     is not known if one approach is better than the other. This randomized study will evaluate~     and compare the efficacy of CPVA versus SPVI in subjects undergoing ablation for paroxysmal~     atrial fibrillation only. Subjects will have a 50/50 chance of receiving either the CPVA or~     SPVI ablation method.~   "
111602|NCT02106650|"~     This study is to evaluate the effect of leucovorin in preventing or reducing Folotyn-related~     Grade 3 or higher oral mucositis.~   "
111603|NCT02106637|"~     The hypothesis of this study is that combination of Varenicline treatment with nurse-led~     hospital support during hospitalization and after discharge will result in clinically~     significant higher long term abstinence rates in smokers with ACS, as compared with nurse led~     support and placebo, without a significant increase in the risk of adverse events.~   "
111604|NCT02106624|"~     The patients with sepsis are in high risk of malnutrition, which could contribute to~     infection, difficulty in weaning from ventilators. The investigators speculate whether~     nutrition therapy with high nitrogen could attenuate the malnutrition status and improve the~     outcome in these sepsis patients. In this prospective Randomized Controlled Trial, the~     investigators aim to compare high nitrogen intake with conventional nitrogen supply which~     were recommended in guidelines.~   "
111605|NCT02106611|"~     This study will test whether cardiac MRI can improve early detection of Hodgkin lymphoma~     associated heart disease compared to a stress echocardiogram. By doing both stress~     echocardiography and cardiac MRI, we will compare the ability of the two tests to detect~     heart disease.~   "
111606|NCT02106598|"~     Current imaging devices usually detect cancer prior to surgery. However, these devices cannot~     be used during the surgical procedure to visualize lymph nodes with cancer (called sentinel~     lymph nodes). The groups are for head and neck melanoma, gynecologic, and breast cancers. As~     a part of the standard of care, the they will initially undergo imaging of their lymph nodes~     prior to their surgery. Melanoma and breast cancer patients will be injected with a~     radioactive dye around the tumor site, and images will be acquired about 2 hours the location~     of the later using a device to image the dye. For gynecologic cancer patients, they will be~     injected with a indocyanine green in the operating room and then images will be acquired soon~     after. In addition, the investigators will test, for the first time in humans, a new,~     experimental dye-labeled particle (dots), cRGDY-PEG-Cy5.5-C dots for lymph node mapping. This~     particle, the size of a small protein, will be injected around sites of melanoma before or~     during your surgery to identify diseased nodes using a hand-held camera system. The~     dye-labeled particle can be viewed in tissues that may contain tumor. Based upon the clinical~     diagnosis, the patient may have a procedure called Reverse Lymphatic Mapping, which is a new~     form of sentinel lymph node mapping. The doctor will discuss this with the patient. If the~     patient is undergoing reverse lymphatic mapping, they will have the experimental particle~     injected into their hand or foot (based on their tumor type) and the standard of care~     injection will be injected around the tumor. This will allow the surgeon to remove only the~     lymph nodes that directly link to the tumor. The particles will not treat the cancer and any~     images or information found during this study will not be used for your treatment. The~     information collected may be used to guide the design of future studies to detect and/or~     treat tumors.~   "
111607|NCT02106585|"~     The purpose of this study is to evaluate the safety, tolerability, and PK (Pharmacokinetics)~     of single oral doses of JTT-251 in healthy and type 2 diabetes mellitus subjects and to~     evaluate the effect of food on the PK of JTT-251 in healthy subjects.~   "
111608|NCT02106572|"~     The aim of this phase III study is to assess the efficacy of abnobaVISCUM® 900 compared with~     Mitomycin C (MMC) monotherapy in patients with superficial bladder carcinoma by evaluation of~     the time to tumor recurrence. Secondary objective is to evaluate the safety of abnobaVISCUM®~     900, in particular, to compare the toxicity of the two treatments. Another secondary~     objective is the treatment efficacy as measured by calculated prognosis for recurrence and~     progression after 1 year, the tumor grading in case of a recurrence and by measurement of~     Quality of Life.~   "
111609|NCT02106559|"~     This pilot clinical trial studies photodynamic therapy during surgery in treating patients~     with pleural (the protective lining or membrane that covers the lungs and chest cavity)~     malignancy. Photodynamic therapy is an anti-cancer treatment that combines a photosensitizer~     (a substance that makes cells more sensitive to light), such as porfimer sodium, together~     with oxygen and visible light to kill tumor cells and/or damage the tumor's blood supply.~     Intraoperative (during surgery) photodynamic therapy may kill any tumor cells that remain~     after surgery.~   "
111610|NCT02106546|"~     This is a 2 arm Phase 3 study to evaluate the safety and efficacy of the addition of~     veliparib plus carboplatin and paclitaxel versus the addition of placebo plus carboplatin and~     paclitaxel in subjects with advanced or metastatic squamous NSCLC.~   "
111611|NCT02106533|"~     The purpose of the present study was to test the hypothesis that patients with coronary~     artery disease with lower aerobic fitness exhibit greater responsiveness on improving~     ventilatory efficiency after aerobic exercise training.~   "
111679|NCT02105636|"~     The purpose of this study is to find out whether Nivolumab will significantly improve overall~     survival as compared to therapy of investigator's choice in patients with recurrent or~     metastatic head and neck carcinoma.~   "
111680|NCT02105623|"~     The purpose of this study is to compare standard therapy (risk factor control, life style~     modification) versus standard therapy plus low-dose rosuvastatin therapy (5mg/day) on~     progression of coronary atherosclerosis in statin naive individuals who have mild CAD~     (nonobstructive coronary atherosclerotic plaques) and normal LDL (low-density lipoprotein)~     cholesterol levels(〈130mg/dl).~   "
111612|NCT02106520|"~     Hereditary Hemorrhagic Telangiectasia (HHT) is a rare (~ 1/6000) but ubiquitous genetic~     disease. It is associated with abnormal angiogenesis and autosomal dominant inheritance,~     leading to telangiectasias and arteriovenous fistulae. More than 95% of patients are~     concerned by epistaxis (nosebleeds). These events are spontaneous, repeated, irregular, both~     diurnal and nocturnal, a source of anemia, disabling and very socially embarrassing.~      Anti-angiogenic treatments, including bevacizumab, are a new therapeutic option in HHT.~      The aim of this study is to evaluate 3 months after the end of the treatment the efficacy on~     the duration of the nosebleeds with 3 different doses (25, 50 and 75 mg) of bevacizumab~     administered as a nasal spray in a repeated manner (3 administrations) in patients with~     Hereditary Hemorrhagic Telangiectasia complicated by nosebleeds.~      This randomized, double-blind, placebo-controlled, seamless phase II/III study is to be~     carried out on 4 groups of 20 patients for first step and 2 groups of 20 to 40 patients for~     second step~   "
111613|NCT02106507|"~     The purpose of this study is to test the safety of the combination of apalutamide plus~     everolimus at different dose levels.~   "
111614|NCT02106494|"~     The primary study objective is to demonstrate the superiority of APF530 500 mg given~     subcutaneously (SC) compared with ondansetron 0.15 mg/kg given intravenously (IV) (up to a~     maximum of 16 mg) in the delayed-phase (> 24-120 hours) complete response (CR) rate (defined~     as no emesis and no use of rescue medications) in subjects receiving highly emetogenic~     chemotherapy (HEC) as defined by the 2011 ASCO CINV guidelines~   "
111615|NCT02106481|"~     The purpose of this study is to compare two methods of pain control used during total knee~     joint replacement surgery. The pain medication that will be used for this study is not~     experimental.~      The investigators will compare the single shot femoral nerve block (SSFNB) and Femoral Nerve~     Block (FNB) plus continuous femoral nerve catheter (CFNC) to determine which method gives~     patients better pain control, increasing the capability to participate in physical therapy~     and decreasing the consumption of other pain medication. With either the single shot or the~     catheter the local numbing medication called ropivacaine will be used.~   "
111616|NCT02106468|"~     This study was initiated to evaluate the potential of dietary supplementation of omega-3 for~     providing an inexpensive, safe and effective therapeutic agent for managing atrophic/erosive~     lichen planus.~   "
111617|NCT02106455|"~     The purpose of this study is to evaluate the safety and efficacy of sodium risedronate~     tablets (Benet 17.5 mg Tablets) administered once daily (one tablet per dose) in patients~     with osseous Paget's disease for 48 weeks from baseline in daily medical practice.~   "
111618|NCT02106442|"~     The purpose of this study is to evaluate the efficacy (endpoints: frequency of bone~     fractures, percent change in bone density, etc.) and safety of administration of sodium~     risedronate tablets (Benet 75 mg Tablets) for 36 months in osteoporosis patients in daily~     medical practice.~   "
111619|NCT02106429|"~     Pathological and clinical studies have consistently demonstrated that abnormalities in~     thrombosis and hemostasis play a major role in the pathogenesis of atherosclerosis and~     atherothrombosis. Screening for abnormalities in thrombosis and hemostasis by measuring~     platelet activity, thrombin generation, and markers of coagulation have been proposed to~     identify individuals at high-risk for cardiovascular events, however, it remains a research~     tool not ready for implementation in standard care.~      The proposed study will add to the growing understanding of platelet activity and markers of~     coagulation in cardiovascular disease; examine a comprehensive battery of platelet activity~     markers, thrombin generation, markers of coagulation, and inflammatory biomarkers in subjects~     undergoing vascular surgery; and will provide important data on the mechanism of increased~     platelet activity using micro RNA, RNA and DNA expression profiling. The study design is~     prospective and the main outcome measures are platelet activity, coagulation markers and~     incident cardiovascular and bleeding events.~   "
111620|NCT02106416|"~     The purpose of this study is to develop a novel technique for integrated PET/MRI tracer~     kinetic analysis for urologic malignancy.~   "
111621|NCT02106403|"~     The objective of this randomised, examiner and subject blinded study is to evaluate and~     compare cooling performance and overall consumer liking of the prototype formulation with the~     currently marketed wound spray and negative control in subjects with experimental wounds. For~     each subject, three superficial wounds will be induced on two volar forearms, by sequential~     tape strippings until a glistening layer is visualized. After wounding, a randomised test~     product will be sprayed twice on test site, and the subject will be asked to complete a~     questionnaire evaluating product cooling performance and overall liking.~   "
111622|NCT02106390|"~     The purpose of this trial is to evaluate the immunogenicity, the safety and the tolerability~     of rMenB+OMV NZ and MenACWY vaccines in healthy infants, when concomitantly administered at~     3, 5, 7 and 13 months of age, compared to either alone.~   "
111623|NCT02106364|"~     The main purpose of this study is to compare the efficacy and safety of a new basal insulin,~     insulin peglispro, to insulin glargine in participants with type 2 diabetes mellitus (T2DM).~     Both drugs will be given by an injection under the skin. Participants may continue to take~     oral antihyperglycemic medication (OAM) during the study, as prescribed by their personal~     physician. The study is expected to last about 12 months for each participant.~   "
111624|NCT02106351|"~     The purpose of this study is to assess the efficacy and safety of multiple doses of Dysport~     used in the treatment of upper limb spasticity (altered skeletal muscle performance) in~     children with cerebral palsy (CP).~   "
111625|NCT02106338|"~     This is a Phase I, single center, randomized, placebo-controlled, double-blind, multiple~     ascending dose study to evaluate the safety and tolerability of CRS3123, a methionyl-tRNA~     synthetase inhibitor. In this study, doses of 200, 400, and 600 mg, or 100mg are planned and~     will be given orally every 12 hours for 10 days. Up to 30 healthy male and female subjects 18~     to 45 years, inclusive. The primary objective: of the study is to determine the safety and~     tolerability of escalating doses of CRS3123 following oral administration of multiple doses~     to healthy adults. The study duration is 46 weeks.~   "
111764|NCT02104531|"~     The investigators purpose is to determine the ability of a low cost, currently available~     imaging technique to predict shoulder movement disorders and the location of shoulder disease~     based on motion analysis of subjects with known shoulder disorders.~   "
111765|NCT02104518|"~     In this study the investigators propose to evaluate the performance of several G6PD testing~     platforms.~   "
111626|NCT02106325|"~     Investigators will conduct a trial to evaluate the use of Ketamine as an alternate treatment~     for people with Major Depressive Disorder. This study plans to explore the potential that~     Ketamine's rapid antidepressant action holds for improving outcomes in patients presenting to~     the Emergency Department with severe depression. since this is a controlled trial we will use~     an IV of Ketamine or and equivalent volume of Diphenhydramine. Sixty subjects will be~     randomly assigned to receive Ketamine (30 participants) or Benadryl(30 participants).~     Investigators will then compare measures of mood pre- and post-infusion in the Emergency~     Department. to supplement self-reported measures of depressive symptoms(e.g. mood),~     investigators will obtain objective measures of the biological aspects of Major Depressive~     Disorder. With the current evidence pertaining to our hypothesis, investigators hope to add~     to the growing scientific studies surrounding such a vulnerable population.~   "
111627|NCT02106312|"~     To study the feasibility of reducing the dose of preoperative radiotherapy in MLS (Myxoid~     Liposarcomas) from 50 Gy to 36 Gy while maintaining comparable clinicopathological responses.~   "
111628|NCT02106299|"~     To evaluate the treatment safety and efficacy of Regen Sling developed by medprin~     Regenerative Medical Technologies Co., Ltd. for female patients with stress urinary~     incontinence~   "
111629|NCT02106286|"~     A major determinant of perioperative mortality is the inability of the heart to increase its~     output in response to surgical stress. This is termed perioperative cardiac failure (PCF),~     and may only be apparent postoperatively when oxygen demand is increased. The risk of~     perioperative cardiac complications is the summation of the individual patient's risk and~     cardiac stress related to the surgical procedure1. The functional capacity of the patient~     determines their ability to support the postoperative demand of increased oxygen consumption,~     and therefore of cardiac output. Exercise capacity is one of the most powerful predictors of~     cardiovascular and all cause mortality2. Cardiopulmonary exercise test (CPET) is an~     established investigation used, among other applications, in the preoperative assessment of~     patient fitness for surgery3. CPET involves monitoring the electrocardiographic trace and the~     exhaled gas mixture (particularly CO2, whose production depends on aerobic metabolism),~     during incremental exercise (usually on an exercise bike), on room air. Several parameters~     can be measured during CPET, including maximal systemic oxygen delivery, the anaerobic~     threshold (the oxygen delivery value at which anaerobic metabolism begins), maximum workload,~     and ST segment depression/elevation (as in a standard exercise tolerance test). The~     cardiopulmonary performance during CPET has been correlated with postoperative outcome3.~     Pulmonary function tests will be performed in order to assess lung function.~      It is well known that therapy with beta-blockers in patients with ischaemic heart disease and~     cardiac failure reduces perioperative morbidity and mortality4-7. However, beta blockers~     reduce myocardial contractility and the heart rate response to adrenergic stimulation, thus~     blunting the physiological response to stress/surgery/exercise. Whilst this mechanism may~     protect the heart perioperatively, it may decrease the ability of some patients to withstand~     other complications. This potential decrease in performance has never been quantified.~      There is no agreement on whether preoperative CPET should be performed on or off~     beta-blockers and, at Aintree in particular, it is standard procedure to take patients off~     beta-blockers prior to their CPET. Some argue that, as beta-blockade should be maintained in~     the perioperative period, CPET should be performed on medications, even if these could mask~     the presence significant ischaemic heart disease (a significant, modifiable, risk factor for~     surgery by beta blockade), and even if it is not always possible to maintain beta-blockade~     throughout the whole postoperative period. For these reasons, other clinicians prefer to~     perform CPET off beta-blockers, thus, potentially, overestimating the perioperative~     cardiorespiratory performance, which may be diminished once the medications are resumed.~     Patients on long-term beta blockade may develop some tolerance to the medications, so the~     effect of acute and chronic beta blockade on cardiorespiratory performance may also be~     different.~      Aim To compare cardiopulmonary performances on and off beta blockers as objectively assessed~     by cardiopulmonary exercise testing.~   "
111630|NCT02106273|"~     An observational pilot study to determine the success rate of using LMA Proseal in conjuction~     with endobronchial blocker to provide one-lung anesthesia for thoracic surgery.~   "
111631|NCT02106260|"~     This phase I/IIa study has an open-label, First-in-Human (FIH), single center design to~     assess the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of~     topically applied CLS003 in healthy subjects with cutaneous warts.~   "
111632|NCT02106247|"~     To assess the reduction of ß-amyloid levels in cerebrospinal fluid and plasma and to evaluate~     pharmacokinetics, safety and tolerability following single oral doses of BI 1181181.~   "
111633|NCT02106234|"~     Contrast-induced nephropathy (CIN) is a side-effect of intravascular administration of~     iodinated contrast material. It is defined as an absolute (>44μmol/l) or relative (>25%)~     increase in serum creatinine from baseline values within 48-72 hours of iodinated contrast~     material administration, and usually resolves within two weeks. In some cases CIN has been~     associated with persistent renal failure, increased risk of dialysis, and mortality. It is~     not clear however, whether CIN is causally related to this increased risk or whether risk of~     morbidity and mortality is inherent in those at risk of CIN.~      CIN itself is asymptomatic and no treatment for CIN exists. Therefore, the focus lies on its~     prevention. Prevention guidelines have been drawn up in most countries and been implemented~     in most radiological departments. In the Netherlands, currently two guidelines for the~     prevention of CIN coexist, issued by CBO (Centraal BegeleidingsOrgaan) and VMS (Veiligheids~     Management Systeem).~      The prevention guidelines aim to increase patient safety by identifying patients that may be~     at risk of CIN (mostly patients with chronic renal insufficiency), and subsequently~     administering prophylactic intravenous hydration to the so identified patients, in order to~     prevent CIN (intravenous normal saline 4-12 hours before and 4-12 hours after exposure to~     iodinated contrast material).~      Needless to say, the introduction of these guidelines has had a great impact on patient- and~     health care burden. In the Netherlands alone it is estimated that yearly 100.000 to 150.000~     patients receive the prophylactic treatment, incurring a total cost of over 50 million Euro.~     Considering the steady yearly increase of contrast procedures and the ageing population, it~     is evident that, in future, these numbers shall only increase further.~      The prophylactic treatment prescribed by the guidelines is based on a consensus of the~     opinion of experts in general agreement that the treatment is beneficial. However, the~     effectiveness of prophylactic hydration has never been adequately evaluated. Sufficiently~     large randomised trials comparing prophylactic intravenous hydration with a proper control~     group receiving no prophylactic treatment are not available, and baseline CIN incidences in~     untreated populations are unknown. Thus, it is not clear whether prophylactic hydration~     achieves its aim to prevent CIN.~      In order to be able to take effective measures to the benefit of patient safety, it is~     important to distinguish between the mechanisms underlying CIN and the ensuing increased risk~     of morbidity and mortality: whether it be biological variation of serum creatinine, renal~     damage, or cholesterol embolism; whether any causality exists between these and iodinated~     contrast material; and whether prophylactic intravenous hydration can prevent these from~     occurring without incurring more risks than it removes. These, in short, are the aims of the~     AMACING study.~   "
111634|NCT02106221|"~     The purpose of this study is to support enhancement, implementation, and evaluation of an~     improved model for delivering improved primary care to high-risk older adults through the use~     of health IT tools, focusing on issues related to the patient-centered primary care home~     (PCPCH) and other similar high-value elements that are proposed to improve patient outcomes.~     During this study, participating clinics will utilize the already-implemented Integrated Care~     Coordination Information System (ICCIS). Clinic staff will meet with a practice facilitator~     (monthly and as needed), and will track study activities and submit invoices via ICCIS~     reporting. These invoices will be used to simulate a shared savings model where clinics will~     be reimbursed based on their progress and effort towards their goals.~      Clinics will set and work towards goals that they have chosen. Goals for the control arm are~     self-selected by the clinics themselves; goals for the invention arm are related to~     high-value elements (HVE) that have been identified as areas that can improve patient~     outcomes. These HVE are:~        1. Evidence-based Care Management Based on Need~        2. Identification of At-Risk Populations~        3. Patient Engagement and Alerts Based on Goals~        4. Integrated Information for Care Management, especially around Utilization~        5. Population Management Tools~   "
111766|NCT02104505|"~     To test the hypothesis that gamma tocopherol (vitamin E) supplement inhibits endotoxin~     induced airways inflammation in allergic asthmatics~   "
111635|NCT02106208|"~     Market trends depicted by Agriculture and Agri-Food Canada suggest stagnation in cheese~     consumption, with potentially important impact on this key industry in Canada. This is in~     part due to the commonly accepted notion that saturated fat in the diet, of which cheese~     contributes significantly, increases the risk of heart disease. Yet, a rather large body of~     recent evidence suggests that saturated fat may have been unfairly demonized and that its~     impact on the risk of heart disease may in fact be less important than originally thought.~     This concept that dairy fat increases the risk of heart attacks therefore needs to be~     revisited, and this is one of the key objectives of this proposed research program.~      The proposed research is designed to investigate for the first time if dairy fat improves the~     levels of the so-called good cholesterol, a protective risk factor that has been~     essentially ignored in the arguments supporting the reduction of saturated fat for heart~     health.~      Our hypothesis is that consumption of SFA from dairy (cheese) compared with a low fat diet~     and diets rich in MUFA and PUFA leads to favorable changes in plasma HDL-C concentrations and~     functional characteristics. Consumption of SFA from dairy (cheese) also increases LDL~     particle size, reduces inflammation and has no deleterious impact on plasma LDL-C and~     apolipoproteins B (apoB) concentrations compared with a low fat diet.~   "
111636|NCT02106195|"~     The primary objective is to assess the safety and tolerability of 200 mg of KD025~     administered orally once daily for 28 days~   "
111637|NCT02106182|"~     The objective of this study is to determine safety and efficacy of silodosin, which is a~     treatment for benign prostatic hyperplasia with high selectivity to α1A-receptor, on patients~     with benign prostatic hyperplasia accompanied by nocturia.~   "
111638|NCT02106169|"~     The purpose of the study is to determine whether therapeutic education can improve the~     quality of life of the child from 8 to 12 years old suffering of food allergy.~      This study also show us if therapeutic education has an effect on the quality of life of~     child's family.~   "
111639|NCT02106156|"~     This observational study will examine the efficacy and safety of pegylated interferon~     (peginterferon) alfa-2a, mostly in combination with ribavirin treatment in chronic hepatitis~     C (CHC). Quality of care will also be assessed. Approximately 12% of the interferon-treated~     CHC patient population in Germany is expected to be studied over a period of 5 years.~   "
111640|NCT02106143|"~     Cryotherapy has a long history of safe use in various medical procedures. RejuvenAir System~     radial spray cryotherapy is a novel procedure being developed as a treatment for conditions~     associated with abnormal bronchial function, such as chronic bronchitis. The development of~     appropriate reliable equipment, definition of therapeutic parameters, and an understanding of~     the tissue effects of treatment have been established through animal studies. This clinical~     study is being undertaken to assess the feasibility and safety of the application of a radial~     metered dose spray cryotherapy in the human airway and to evaluate the treatment depth in~     human airways. The study design is prospective, open label, single arm multi-center study~     that will consist of up to 15 subjects at up to 3 enrolling sites in Ireland, UK and The~     Netherlands RejuvenAir System treatment will be performed during preoperative bronchoscopy 0~     to 60 days prior to prescheduled lung resection in Subjects requiring lobectomy or~     pneumonectomy for removal of peripheral tumors. Treatment will be limited to areas of the~     bronchi within the lobe that will be removed, distal to the anticipated margin of resection.~     Treatment should be at least 1 cm from the bronchial resection margins and away from the~     tumor bed. Treated airways will be inspected via bronchoscopy at the time of thoracotomy, and~     examined histologically following surgical resection. Subject participation will be from 1 to~     60 days and enrollment is anticipated to take 4-5 months.Total study duration is expected to~     last approximately 10 months.~   "
111641|NCT02106130|"~     The investigators investigate the potential pharmacokinetic drug-drug interaction between~     Mosapride citrate 5 mg and Rebamipide 100 mg in healthy male volunteers who receive Mosapride~     citrate 5 mg, Rebamipide 100 mg, and both together in a 2 period repeatedly.~   "
111642|NCT02106117|"~     Although the clinical outcome in patients with Invasive Aspergillosis (IA) is largely~     dependent on early initiation of effective treatment with antifungal drugs, diagnosing IA is~     still a critical problem. Symptoms are non-specific and available diagnostic tools are either~     invasive or have low sensitivity and specificity. This often results in a diagnostic delay,~     with patients developing more extensive disease. Furthermore, as long as IA is present,~     oncological follow-up treatment is not feasible. Inaccuracy in diagnosing IA can cause~     serious treatment delay and increased mortality. However, an empirical strategy with~     prophylactic anti-mould therapy is not feasible considering both possible side effects and~     costs. In order to safely continue the use of a pre-empirical strategy, improved~     (non-invasive) diagnostic tools are desirable.~      In a pilot study de Heer et al. showed that it is possible to discriminate between patients~     with IA and their neutropenic controls by exhaled breath analysis using an electronic nose~     (eNose). In this study the investigators aim to test whether an eNose could be useful as a~     diagnostic tool in a prospective setting.~      The gold standard in exhaled breath analysis is Gas Chromatography - Mass Spectrometry~     (GC-MS). This technique enables identification of volatile organic compounds (VOCs) in breath~     of patients. It is possible that there are Aspergillus specific VOCs in the breath of~     patients with IA.~      The composition of the lung microbiome seems to be an important factor in both health and~     disease. It is likely that the microbiome of the lung changes in prolonged neutropenia,~     therefore possibly creating a niche for molds and yeasts. Comparing the microbiome of~     patients with prolonged neutropenia who develop IA with those who do not, can learn us more~     about the pathogenesis of this disease. This knowledge could be used to investigate new~     treatment options for Invasive Aspergillosis.~      Hypothesis The investigators hypothesize that airway microbial (viral, bacterial) presence~     and exhaled molecular profiles as obtained from patients with prolonged neutropenia due to~     treatment of hematological malignancies, are different between patients who develop IA and~     patients who do not.~   "
111643|NCT02106104|"~     The aim of this study is to detail the (mechanisms underlying the) actions of the DPP-4~     inhibitor linagliptin on the renal system in patients with type 2 diabetes mellitus.~   "
111644|NCT02106091|"~     The purpose of this study is to determine whether AFM11 is safe and active in the treatment~     of relapsed and/or refractory Non-Hodgkin Lymphoma (NHL).~   "
111645|NCT02106078|"~     The investigators hope to learn whether access to online support and education can help~     people with Bipolar Disorder (BD) better manage their symptoms of depression.~   "
111646|NCT02106065|"~     The purpose of this study is to study the effects of an education and skill-building~     intervention on family caregivers of Veterans with dementia.~   "
111726|NCT02105025|"~     Colonoscopy is the current common method for management of colorectal diseases, and~     effectiveness of colonoscopy associate with complication rate. A lot of patients were failed~     because of technical difficulty, those required more than 10 min to intubate the cecum are~     consider as difficult colonoscopy, in such condition, specialized equipment or maneuvers may~     be required for a successful colonoscopy. Thus, it is important to set up a clinical model to~     predict the technical difficulty of the examination in preoperational stage.~   "
111647|NCT02106052|"~     Cognitive impairment affects roughly 50% of people with multiple sclerosis (MS). There are~     currently no satisfactory medical treatments for cognitive impairments related to MS and~     alternative forms of treatment are needed. Exercise training can improve cognition in older~     adults and people with mild cognitive impairments, including those with early Alzheimer's~     disease. Therefore, the investigators plan to conduct the first definitive study that will~     test the theory that moderately intense aerobic exercise can improve cognition in people with~     MS-related impairment - specifically in information processing speed - more so than~     non-aerobic stretching and toning (both forms of exercise will be performed 3 days per week~     for 6 months).~      Primary study hypothesis: The investigators hypothesize greater improvement in speed of~     information processing from pre- to post-treatment in the aerobic exercise group compared to~     the stretching and toning group (attention control).~      Secondary study hypothesis: The investigators hypothesize greater improvement in other~     cognitive domains and patient reported outcomes from pre- to post-testing in the aerobic~     exercise group compared to the stretching and toning group (attention control).~      The investigators plan to recruit 125 adults with MS who can walk without assistance and~     without rest for at least 100 meters and have mild weaknesses in information processing~     speed. The investigators will randomly assign 50% of participants to an aerobic exercise~     program and 50% to a non-aerobic exercise program (stretching and toning). In order to~     determine whether the intervention is successful, the investigators will compare cognitive~     functioning in both exercise groups before the exercise-training program, at the end of the~     6-month training program and three months after the end of the training program. If our study~     findings support our hypotheses, this would be a relatively no-barriers treatment option to~     further explore for other people with MS including people with greater and lesser baseline~     disability.~   "
111648|NCT02106039|"~     The purpose of this study is to evaluate the effect of enhanced glycemic monitoring of~     diabetes upon diabetes glycaemic control during tuberculosis treatment in tuberculosis-~     diabetes patients.~   "
111649|NCT02106026|"~     An antenatal education intervention in primiparous women improves breastfeeding duration and~     reduces post-natal complications.~   "
111650|NCT02106013|"~     This is a study of HDL function in healthy individuals classified in three groups according~     to their HDL-cholesterol levels (Low HDL-C, Intermediate HDl-C and High HDL-C), with the~     purpose of investigating which characteristics of the HDL particle might be associated to~     atherosclerotic burden, characterized by carotid intima-media thickness above 1mm.~   "
111651|NCT02106000|"~     The purpose of this study is to record and compare the inhalation profiles of non pregnant~     women and those who are in the third stage of labour. The inhalation profiles will be~     recorded from consenting women as they inhale with maximal effort through an inhalation~     profile recorder [Glaxosmithkline (GSK), Ware]. The recorder will simulate resistance to~     airflow and will be representative of a dry powder inhaler of moderate resistivity. The~     inhalation endpoints will include Peak Pressure Drop, Peak Inspiratory Flow Rate, Inhaled~     Volume, Inhalation time, Average Inhalation Flow Rate and Acceleration rate which will be~     compared between the two female cohorts. Inhalation profiles recorded in this way may~     subsequently be used to study the in-vitro performance of investigational materials across~     inhalation parameters representative of the target patient population.~      An appropriate number of subjects will be consented so that approximately 40 subjects (20~     non-pregnant females and 20 stage three labour subjects) complete assessments. The inhalation~     profiles will be recorded on the same day of screening or at another time within a span of 50~     days~   "
111652|NCT02105987|"~     This study is a 48-week, Phase IIIb, randomly assigned, open-label, active-controlled,~     multicenter, parallel group, non-inferiority study. This study is designed to demonstrate the~     non-inferior antiviral activity of switching to the Abacavir (ABC) 600 milligrams~     (mg)/Dolutegravir(DTG) 50 mg/Lamivudine (3TC) 300 mg fixed-dose combination (FDC) compared~     with continuing the subject's current suppressive regimen through 24 weeks. The study will be~     conducted in approximately 538 Human Immunodeficiency Virus -1 (HIV-1) infected individuals~     who are on stable suppressive combination antiretroviral therapy (cART) with 2 Nucleoside~     reverse transcriptase inhibitors (NRTIs) plus either a protease inhibitor (PI), an~     non-nucleoside reverse transcriptase inhibitor (NNRTI), or an integrase inhibitor (INI).~     Eligible subjects will be randomly assigned 1:1 to continue their current regimen~     (approximately 269 subjects) or be switched to ABC/DTG/3TC FDC (approximately 269 subjects)~     once daily for 24 weeks. At Week 24, individuals originally randomly assigned to continue~     their current regimen will switch to ABC/DTG/3TC FDC and be followed for an additional 24~     weeks. Individuals initially randomly assigned to ABC/DTG/3TC FDC will continue on that~     treatment arm for an additional 24 weeks. A pharmacokinetic (PK) substudy will be conducted~     at a small number of sites (approximately 10) to evaluate predose DTG concentrations as well~     as residual drug concentrations of efavirenz (EFV), nevaripine (NVP), amprenavir (APV) and~     tipranavir (TPV) in a subgroup of subjects who switch from EFV, NVP, fosamprenavir/ritonavir~     (FPV/r) or tipranavir/ritonavir (TPV/r).~   "
111653|NCT02105974|"~     This is a Phase IIIa, multicenter, randomized, stratified (reversibility status),~     double-blind, parallel-group study to evaluate the efficacy and safety of FF/VI 100/25~     micrograms (mcg) once daily (QD) compared with VI 25 mcg QD, administered in the morning via~     the ELLIPTA™ inhaler. The primary objective of this study is to evaluate the contribution on~     lung function (as measured by trough forced expiratory volume in one second [FEV1]) of FF 100~     mcg to the FF/VI 100/25 mcg QD combination by comparison of the latter with VI 25 mcg QD and~     the safety of FF/VI 100/25 mcg over a 12-week treatment period in subjects with COPD.~     ELLIPTA™ is a registered trademark of GlaxoSmithKline.~   "
111654|NCT02105961|"~     This is a multi-centered, randomized, placebo-controlled, double-blind, parallel group, trial~     evaluating 2 doses of mepolizumab against placebo given every 4 weeks through subcutaneous~     (SC) injection. In severe COPD subjects, sputum eosinophils levels are elevated to similar~     levels as those seen in severe asthmatics. It is hypothesized that the reduction of~     eosinophils with mepolizumab in COPD subjects would translate into a reduction of COPD~     exacerbations. The study will evaluate the efficacy and safety of mepolizumab, in subjects~     who are at or above the baseline blood eosinophil count of at least 150 cells/microliters who~     exacerbate despite regular use of maximal tolerated therapy, appropriate for severe COPD~     subjects, in the 12 months prior to study start. In total, 660 subjects will be randomized in~     1:1:1 ratio to receive mepolizumab 300 mg, mepolizumab 100mg, or placebo administered SC. The~     total duration of subject participation will be approximately 62 weeks, consisting of a 1 to~     2 week screening period, 52-week treatment period and 8-week follow-up period.~   "
111698|NCT02105389|"~     Cancer-related fatigue (CRF) is a major problem in children, adolescents and adults receiving~     treatment for cancer, and intensively treated patients may be at higher risk. While exercise~     is an effective intervention for CRF, patients receiving the most intensive chemotherapy may~     frequently be too ill to participate in a standardized exercise program. A unique~     intervention that combines exercise and relaxation is yoga. This pilot study will evaluate~     the feasibility of three times weekly yoga sessions administered by a trained yoga instructor~     for a three week duration and will enroll between 10 and 20 children. If feasible, the~     intervention will be tested in a randomized controlled trial.~   "
111655|NCT02105948|"~     This is a multi-center, randomized, placebo-controlled, double-blind, parallel group trial~     evaluating mepolizumab 100 mg against placebo given every 4 weeks through subcutaneous (SC)~     injection.~      In severe COPD patients, sputum eosinophils levels are elevated similar as those seen in~     severe asthmatics. It is hypothesized that the reduction of eosinophils with mepolizumab in~     COPD patients would translate into a reduction of COPD exacerbations. The study will~     determine the reduction in exacerbations in subjects who are above and below the baseline~     blood eosinophil count of at least 150 cells/microlitres. The study will evaluate the~     efficacy and safety of mepolizumab on the frequency of moderate and severe exacerbations in~     COPD subjects at high risk of exacerbations, despite the use of optimized standard of care~     background therapy.~      Overall in this study, a total of 800 subjects will be randomised in 1:1 ratio to receive~     placebo or mepolizumab (100 milligram (mg)) administered SC. The total duration of this study~     will be approximately 62 weeks, consisting of a 1 to 2 week screening period, 52-week~     treatment period and 8-week follow-up period.~   "
111656|NCT02105935|"~     This study's objectives are:~        -  To prospectively examine changes in brain network activation (BNA™) from baseline to~          recovery (i.e., return to activity) in youth and adolescent athletes with concussion.~        -  To assess the clinical utility of changes in BNA to assist in clinical decision-making.~        -  To generate normative BNA data.~   "
111657|NCT02105922|"~     From 3 interventiongroups in the project with ClinicalTrials.gov ID NCT02034760, namely:~      HRTW: Heavy Strength Training x3/week & 20g whey protein twice daily. LITW: Light Intensity~     Training x3-5/week & 20g whey protein twice daily. WHEY: 20g whey protein twice daily.~      15 subjects from each group will be recruited and tested after 3 months of intervention.~     Tests will include muscle cross sectional area (MRi), muscle biopsies (fiber types, size,~     cell- and capillary count), functional- and strength measurements, plasma lipids, HbA1c.~     Tests are to be compared with Project ID NCT01997320.~   "
111658|NCT02105909|"~     This is a GWAS pilot study that aims to identified possible candidate genes associate to~     obesity by exploring single nucleotide polymorphism (SNP) in a small group of obese ,~     metabolically healthy white adults, matched with lean, white adults , metabolically healthy.~     The investigators hypothesize that the careful phenotyping of the subject sand matching with~     increase the power to find SNP significantly associate with obesity (as defined by BMI).~   "
111659|NCT02105896|"~     Purpose: To evaluate the performance of several dental adhesives used for bonding~     tooth-colored fillings to teeth 6 years after the fillings have been placed.~      Participants: Subjects which had participated in the study entitled Clinical Evaluation of~     New Total-Etch and Self-Etch Dental Adhesives (IRB Study #07-0673).~      Procedures (methods): Fillings that had been placed 6 years ago will be evaluated by a~     direct, visual examination. Close-up intra-oral clinical photographs of each filling will be~     made. An impression of the filling may be obtained.~      The specific study aim of this 6-year recall of the patients treated in IRB Study #07-0673 is~     to evaluate the fillings placed according to the following characteristics: Retention; Color~     match; Cavosurface margin discoloration; Secondary caries; Anatomic form; Marginal adaptation~     and/or integrity; Post-operative sensitivity.~   "
111660|NCT02105883|"~     The purpose of this study is to evaluate if the use of identification badge (role and place)~     during high-fidelity simulation as an impact on situation awareness.~   "
111661|NCT02105870|"~     Microvascular dysfunction is a key determinant of pathogenesis and outcome in patients~     suffering an acute myocardial infarction.~      The investigators hypothesise that treatment with intracoronary abciximab, a potent anti~     platelet agent, at the time of coronary stent insertion, will improve microvascular function.~   "
111662|NCT02105857|"~     The purpose of the study is to find the best way to mobilize a knee after total knee~     arthroplasty (TKA). In particular, the aim of this study will be to investigate the~     advantages of adding a gentle knee mobilization to the standard rehabilitation used by~     physiotherapists in this hospital after TKA.~      All individuals waiting for TKA from the Departement de l'appareill Locomoteur (DAL) -~     Centre Hospitalier Universitaire Vaudoise (CHUV) will be considered for this research trial.~     The number of individuals necessary to complete this study is 32.~      Participants deciding to take part will be given an information sheet and asked to sign a~     consent form. If deciding to take part, they will still be free to withdraw at any time and~     without giving a reason. A decision to withdraw at any time, or a decision not to take part,~     will not affect the standard of care they receive.~      People who agree to take part will be randomly selected into 2 groups: one group will follow~     the standard treatment used in physiotherapy after TKA, the other group will have the same~     treatment and the technique of A+ mobilization in investigation added. Participants have 50%~     chances to be allocated to either of the groups. Before surgery, at the first and seventh day~     after operation, the researchers will measure the range of motion (ROM) of the replaced knee.~     This means that the study will last till the moment the last participant leaves the DAL -~     CHUV, which is estimated to be in 12 months after the first recruitment.~      Individuals over 18 years old undergoing unilateral primary TKA caused by osteoarthritis will~     included. Exclusion criteria will be: a) insufficient French language skills to agree a~     written consent, b) body mass index (BMI) >40 kg/m2, c) symptomatic OA in the contralateral~     knee (defined as self-reported knee pain >4 on a 10-point verbal analogue scale), d) other~     lower extremity orthopedic problems limiting function, e) neurologic impairment or g)~     cognitive dysfunction.~      No life-style restrictions will be requested. Patients will just need to follow the~     physiotherapist's usual advices during the in-hospital period at the DAL - CHUV. This study~     does not alter the standard procedures, patients will receive all the techniques used in~     physiotherapy as every other TKA patient. If allocated into the mobilization group, a~     specific knee splint will be positioned on the patient's knee. This position will be held for~     20 minutes with the leg straight and 20 minutes bent, twice a day. The person in charge of~     these procedures is the principal investigator of the study, a certified orthopedic~     physiotherapist on the staff of the DAL - CHUV. No additional changes to patients' daily~     routine will be involved.~      To the investigators knowledge, there are no side effects due to use of this mobilization.~     Nevertheless, the pain levels of every patient will be recorded to identify any differences~     between groups. If, during or after the clinical study, any patient will face unexpected~     health problems related with the study, they will be kindly asked to transmit the information~     to the principal investigator of the study. The mobilization technique involves no additional~     risk over that of standard treatment performed in the hospital. This study hypothesis that~     adding A+ graded mobilization combined with the standard in-hospital rehabilitation protocol~     will improve ROM without increasing pain.~      All information collected will be kept strictly confidential. Any information used will have~     names and addresses removed. All data will be stored, analyzed and reported in compliance~     with the Data Protection Legislation of Switzerland.~   "
111663|NCT02105844|"~     Swiss-AF is a prospective observational, multicentric cohort study in Switzerland. Overall,~     2600 patients with documented atrial fibrillation aged >65 years will be included and~     followed on a yearly basis.~      Yearly clinical examinations include a detailed questionnaire on personal characteristics, a~     resting electrocardiogram, neurocognitive function tests and questionnaires on disability and~     quality of life. Blood sampling and brain magnetic resonance imaging are scheduled at~     baseline and after 2 years of follow-up.~      The main study aims of this long term prospective study are to increase our knowledge on~     structural brain damage and its changes over time in patients with atrial fibrillation, to~     gain additional insights on the incidence and underlying mechanisms of cognitive decline in~     patients with atrial fibrillation and to evaluate the interrelationships of structural and~     functional brain damage in this population.~   "
111664|NCT02105831|"~     Advanced heart failure (when the heart pump fails) is associated with symptoms such as~     shortness of breath and extreme fatigue. Some of these symptoms are simply due to failure of~     the pump, however abnormal regulation of blood flow to the muscles of the body is also a~     potential mechanism. Left ventricular assist devices are mechanical pumps used to compensate~     for patients with failing hearts either as a bridge to heart transplant or as long term~     therapy. Whether or not these pumps improve muscle flow and whether this is a determinant in~     the improvement of symptoms is unknown. Understanding how skeletal muscle and heart perfusion~     is altered in heart failure patients before and after implantation of an LVAD could provide~     further insight into the beneficial effects of this therapy.~      Specific Aims:~        1. To evaluate skeletal muscle and heart perfusion studies before and after LVAD~          implantation~        2. To compare functional status with degree of skeletal muscle perfusion.~   "
111665|NCT02105818|"~     The purpose of this study is the validation of a newly developed self-report questionnaire~     which aims at determining the prevalence, location and intensity of SWAllowing difficulties~     with drug intake, and describing the impact on MEdication regimen focusing on COping~     strategies (SWAMECO).~   "
111666|NCT02105805|"~     30 obese moderate-to-severe heart failure patients will be randomized to intervention or~     control in groups of 5-10 subjects.~      All will receive dietetic advice according to randomization and according to the European~     Heart Association.~      Intervention subjects will initiate with 8 weeks low energy diet, 800-1000 kcal/d by formula~     diet and subsequent four weeks reintroduction to regular foods supplying 1200 kcal/d~     substituting two daily meals with formula meal replacement.~      Control subjects are advised to follow the Nordic Nutrition Recommendations.~      Patients will be monitored by blood sampling and assessed by change in physical performance.~   "
111669|NCT02105766|"~     Background:~      - Some sickle cell disease or beta-thalassemia can be cured with transplant. Researchers want~     to test a variation of transplant that uses low dose radiation and a combination of~     immunosuppressive drugs. They want to know if it helps a body to better accept donor stem~     cells.~      Objectives:~      - To see if low dose radiation (300 rads), oral cyclophosphamide, pentostatin, and sirolimus~     help a body to better accept donor stem cells.~      Eligibility:~      - People 16 and older with beta-thalassemia or sickle cell disease that can be cured with~     transplant, and their donors.~      Design:~        -  Participants and donors will be screened with medical history, physical exam, blood~          test, tissue and blood typing, and bone marrow sampling. They will visit a social~          worker.~        -  Donors:~        -  may receive an intravenous (IV) tube in their groin vein.~        -  will receive a drug injection daily for 5 or 6 days to move the blood stem cells from~          the bone marrow into general blood circulation.~        -  will undergo apheresis: an IV is put into a vein in each arm. Blood is taken from one~          arm, a machine removes the white blood cells that contain blood stem cells, and the rest~          is returned through the other arm.~        -  Participants:~        -  may undergo red cell exchange procedure.~        -  will remain in the hospital for about 30 days.~        -  will receive a large IV line that can stay in their body from transplant through~          recovery.~        -  will receive a dose of radiation, and transplant related drugs by mouth or IV.~        -  will receive blood stem cells over 8 hours by IV.~        -  will take neuropsychological tests and may complete questionnaires throughout the~          transplant process.~        -  must stay near NIH for 4 months. They will visit the outpatient clinic weekly.~        -  will have 5 follow-up visits for 3 years after transplant, then annually.~   "
111670|NCT02105753|"~     Primary axillary hyperhidrosis is a common idiopathic disorder of the eccrine sweat glands~     that interferes with daily activities and causes significant social distress. This pilot~     study is designed to evaluate the efficacy and histologic effects of the 1210nm diode laser~     for the treatment of axillary hyperhidrosis. Initial results may inform the design of an~     anticipated larger prospective controlled trial. Study participants will receive one laser~     treatment to one randomly-assigned axilla using the 1210 nm diode laser, and two treatments~     to the opposite axilla. Changes in sweating will be measured both by quantitative gravimetric~     analysis of sweat production and by expert panel evaluation of photographs of the~     starch-iodine test performed on each axilla. Participants will also be asked to subjectively~     classify the severity of their axillary sweating. These measures will be performed at~     pretreatment and at one, three, and six months following treatment. Biopsies of both axillae~     will be done before and two weeks after treatment to assess histologic changes to the eccrine~     gland and surrounding structures. Treatment of axillary hyperhidrosis with the 1210nm diode~     laser is a novel approach based on the unique absorption characteristics of this wavelength.~     We hypothesize that selective heating of lipids at the appropriate tissue level will impact~     adjacent eccrine glands typically seated at the dermo-hypodermal junction, leading to~     subjective and/or objective decreases in eccrine secretions. This type of treatment may offer~     an effective, non-invasive and safe alternative to current treatment modalities.~   "
111671|NCT02105740|"~     The aim of this trial is to compare and evaluate the effects of hypnosis in cancer patients,~     to reduce the level of pain, anxiety and depression. The comparison was made through the~     scores on the Visual Analogue Scale (VAS) and the Hospital Anxiety and Depression Scale~     (HADS).~   "
111672|NCT02105727|"~     The objective of this study is to determine whether a community-based salt reduction program~     can reduce average salt consumption levels. Baseline levels of salt consumption were measured~     in 2011, the salt reduction program was then implemented, and now in 2014 investigators are~     remeasuring salt consumption levels in the community. The hypothesis investigators are~     testing is that the salt reduction program will have led to a change in salt consumption~     levels between 2011 and 2014. The study is being done in Lithgow, a regional town in New~     South Wales , Australia.~   "
111673|NCT02105714|"~     NIDIAG is an international collaboration on integrated diagnosis-treatment platforms, funded~     by the European Commission (EC). NIDIAG aims to develop an improved, patient-centred system~     for delivering primary health care in resource-constrained settings. NIDIAG will investigate~     three clinical syndromes, namely (i) persistent digestive disorders, (ii) persistent fever~     and (iii) neurological disorders, due to neglected tropical diseases (NTDs). The current~     study focuses on persistent digestive disorders, which are defined as diarrhoea or abdominal~     pain that last for at least 2 weeks.~      While acute diarrhoea has been studied globally, few research activities have focused on the~     epidemiology, diagnosis and treatment of long-lasting diarrhoeal episodes (2 weeks and~     longer) in the tropics. The spectrum of possibly involved pathogens includes more than 30~     bacterial, parasitic and viral infectious agents. This lack of data may be explained by the~     fact that people suffering from NTDs might only seek care at a late stage of the disease.~     Furthermore, health systems in affected regions are often weak and their primary health-care~     centres are often under-staffed and lack essential diagnostic equipment.~      The hypothesis of this study is that development of an evidence-based syndromic approach can~     lead to better diagnosis and management of NTDs in patients with persistent digestive~     disorders. The study will be carried out in two West African countries (Côte d'Ivoire and~     Mali) and in two Asian countries (Indonesia and Nepal). The study will follow a~     case-control design and patients and controls will be prospectively enrolled. In order to~     address the knowledge gaps, three specific objectives will be pursued. First, the~     contribution of NTDs to the 'persistent digestive disorders syndrome' will be assessed.~     Second, the value of clinical features and rapid diagnostic tests (RDTs) for the diagnosis of~     target NTDs that give rise to persistent digestive disorders will be determined. Third, the~     clinical response to standard empiric and targeted treatment of several NTDs in patients with~     persistent digestive disorders will be evaluated. These objectives will provide a long-term~     benefit for the communities by improving the clinical decision-making process for the target~     NTDs and thus, better diagnostic work-up and patient management can be achieved in the study~     countries and other similar resource-constrained countries~   "
111674|NCT02105701|"~     This is an efficacy and safety study of grazoprevir (MK-5172) in combination with elbasvir~     (MK-8742) with or without ribavirin (RBV) in participants with chronic hepatitis C virus~     (HCV) genotype (GT) 1, 4, or 6 infections who have failed prior therapy with pegylated~     interferon and RBV. The primary study hypothesis is that in at least one of the study arms,~     the percentage of participants achieving sustained viral response 12 weeks after the end of~     all study treatment (SVR12) will be superior to 58%.~   "
111675|NCT02105688|"~     This is a 2-part study. The purpose of Part A is to assess the efficacy and safety of~     grazoprevir (MK-5172) 100 mg in combination with elbasvir (MK-8742) 50 mg for 12 weeks in the~     treatment of chronic HCV GT1, GT4, or GT6 infection in treatment-naïve participants who are~     on opiate substitution therapy (OST). The primary hypothesis is that the percentage of~     participants who receive grazoprevir/elbasvir fixed-dose combination (FDC) in the Immediate~     Treatment Arm and achieve a Sustained Virologic Response 12 weeks after the end of all study~     therapy (SVR12) will be superior to 67%. In addition, participants who received at least 1~     dose of grazoprevir/elbasvir in Part A will be eligible to participate in Part B, which is a~     3-year observational follow-up.~   "
111676|NCT02105675|"~     The purpose of this study is to determine whether DCVAC/PCa added onto Standard of Care~     therapy can improve survival times for patients with Metastatic Castration Resistant Prostate~     Cancer~   "
111677|NCT02105662|"~     The purpose of this study is to assess the efficacy and safety of grazoprevir (MK-5172) 100~     mg in combination with elbasvir (MK-8742) 50 mg in the treatment of chronic hepatitis C virus~     (HCV) in participants who are co-infected with human immunodeficiency virus (HIV). The~     primary hypothesis is that the percentage of participants who receive grazoprevir + elbasvir~     and achieve Sustained Virologic Response after 12 weeks of therapy (SVR12) will be greater~     than 70%.~   "
111681|NCT02105610|"~     There is initial evidence that the choice of anesthesia can influence survival in the~     specific setting of coronary artery bypass grafting surgery (CABG).~      A recent international consensus conference included volatile agents among the few~     drugs/techniques/strategies that might reduce perioperative mortality in cardiac surgery and~     that should be further studied. Volatile anesthetics (desflurane, isoflurane and sevoflurane)~     have non-anesthetic pharmacological characteristics that confer cardiac protection when~     compared to Total IntraVenous Anesthesia (TIVA). Several randomized controlled studies were~     summarized in a meta-analysis that documented a reduction in perioperative cardiac troponin~     release and mortality in patients receiving volatile anesthetics when compared to patients~     receiving a TIVA. There are four published studies (Bignami et al. 2009) (De Hert et al.~     2009) (Jackobsen et al. 2007) (Landoni et al. 2007) suggesting that these benefits can~     translate into a reduced mortality rate in patients receiving volatile agents. The level of~     evidence for these four studies is not high (one meta-regression, one underpowered randomized~     controlled study, one retrospective study and one meta-analysis of small randomized studies)~     and there is need for a large multicentre randomized controlled study to confirm these~     findings, as suggested by the international consensus conference on this topic published in~     2011 (Landoni et al 2011).~      The purpose is to provide a large multicentre controlled randomized trial to demonstrate that~     volatile anesthetics can reduce 1 year mortality from 3% to 2% in patients undergoing CABG~     (either with or without cardiopulmonary bypass).~      The results of this study can support the use of volatile agents in all CABG procedures~     worldwide (more than 500.000 per year) with 2.500 lives saved per year (in the hypothesis~     that nowadays half the procedures are performed with a TIVA and that 1 year mortality can be~     reduced from 3% to 2% using volatile agents).~   "
111682|NCT02105597|"~     Background: Diabetes mellitus (DM) is a major cause of morbidity and mortality worldwide.~     Long-term glycemic control is important to prevent or delay the onset of DM related~     complications. Patients often fail to achieve optimal glycemic control from pharmacotherapy~     due to non-adherence. With the high prevalence of smartphone usage locally and among the~     developed countries, there has been a growing interest to deliver interventions through~     mobile applications. In this study, a mobile application targeted at improving medication~     adherence among people with Type 2 DM will be developed and evaluated.~      Aims: This study aims to (i) design a smartphone application to improve medication adherence~     and (ii) evaluate its impact on clinical outcomes, health-related quality of life (HRQoL) and~     health status among patients with Type 2 DM.~      Hypothesis: The use of a smartphone application can improve medication adherence among~     patients with Type 2 DM, as well as clinical outcomes, HRQoL and health status.~      Methods: This is a randomized, open-label controlled trial involving patients with Type 2 DM~     managed at Singapore General Hospital. Patients seen at the institution's Diabetes Centre and~     those referred to the pharmacist-led Medication Therapy Management service are eligible to~     participate. Patients in the intervention group will have the mobile application downloaded~     onto their smartphones, while those in the control group will receive the usual standard of~     care. The primary outcome will be change in self-reported medication adherence, determined~     using the 8-item Morisky Medication Adherence Scale. Secondary outcomes include change in~     HbA1c, blood glucose, frequency of dose titrations, addition or removal of oral hypoglycemic~     agents, HRQoL (measured using the Audit of Diabetes Dependent Quality of Life) and health~     status (measured using the EuroQol-5D-5L and EuroQol Visual Analogue Scale). All outcomes~     will be measured at baseline and at the end of the 6-month study period (± 4 weeks).~      Significance: The development and evaluation of a mobile application to improve adherence~     among patients with Type 2 DM in Singapore is the first of its kind, and the findings of this~     study will provide the much-needed evidence to demonstrate the effectiveness of this~     intervention.~   "
111683|NCT02105584|"~     This is a prospective, non-randomized, study of the safety and efficacy of the Occlutech® LAA~     occluder indicated for percutaneous LAA closure in adult male or female patients with atrial~     fibrillation. Safety and efficacy will be assessed at day 1, 30 and 90, and after 1 year~     following implantation of an Occlutech® LAA Occluder.~   "
111684|NCT02105571|"~     The current project is a randomized, controlled evaluation of a new weight loss and health~     promotion intervention for truck drivers. The intervention is a 6-month weight loss~     competition supported with computer based training, behavioral self-monitoring, and~     motivational interviewing. We hypothesize that the intervention will produce greater change~     than a usual practices control condition. Our secondary hypothesis is that social support and~     stress in home and work environments will moderate intervention efficacy.~   "
111685|NCT02105558|"~     To compare the effects of epidural versus CSE anesthesia on the success of TOLAC. This will~     be a prospective clinical study randomizing 60 eligible women into either an epidural group~     or CSE group. The effects of the specific regional anesthetic on patient's individual labor~     efforts will then be closely monitored. Written informed consent shall be obtained to enroll~     the patients in either group. Pain scores and electronic medical record information will be~     used with non-identifiable coding to determine the resulting outcomes.~   "
111686|NCT02105545|"~     The goal of this study is to develop a new, local system that will use special tests based on~     patients' genetic makeup to better tailor cancer care at the University of New Mexico Cancer~     Center.~      The Food and Drug Administration has already approved over forty (40) drugs to treat cancer~     patients based on specific genetic makeup, and more agents are in development that will~     support this new approach to treatment, often referred to as personalized medicine.~      The goal of performing specific tests on patients' genetic material is to discover~     tumor-specific, single nucleotide variations (SNVs) and other forms of genetic changes~     (called epigenetic changes) that can be detected when comparing normal tissue and tumor~     tissue. This can help guide cancer care decisions that may be more effective for patients.~     These will be called clinically actionable findings, or CAF.~      Additional health related findings may be made, not related to cancer but to other~     conditions, diseases or syndromes. These are called secondary findings (SF). In this study~     the investigators will also measure how often they find SF and will discuss their possible~     impact on other aspects of patients' health. If patients want to know about these findings,~     they will be discussed with a panel of experts including genetic counselors.~      Finally, the investigators will compare how often CAF and SF differ from those identified in~     nationwide samples.~   "
111687|NCT02105532|"~     Aim: To evaluate the feasibility and safety of a restrictive versus liberal red blood cell~     (RBC) transfusion policy in adult patients admitted with Acute Upper Gastrointestinal~     Bleeding (AUGIB) in order to inform the design of a definitive phase III randomised~     controlled trial.~   "
111688|NCT02105519|"~     In recent years, several studies revealed that the current influenza vaccine strategy might~     be of minimal vaccine effectiveness and had a smaller effect on reducing morbidity and~     mortality in the end-stage renal disease population than previously thought. Thus, this also~     raised the question about the effectiveness of administration of influenza vaccination in~     chronic kidney disease patients not on dialysis. In this study, the investigators aim to~     evaluate the effectiveness of seasonal trivalent influenza vaccine, formulation 2013-2014, in~     patients with different stage of chronic kidney disease (CKD) not on dialysis.~   "
111699|NCT02105376|"~     This is a phase II, randomized, sham controlled, clinical trial. This clinical trial has as~     primary objective to evaluate the effect of the Trigeminal Nerve Stimulation (TNS) on~     depressive symptoms measured by the Hamilton Depressive Rating Scale version 17 items~     (HDRS-17) in patients with moderate / severe depressive episode.~   "
111727|NCT02105012|"~     Study to assess the efficacy and safety of four doses of budesonide inhalation aerosol (BD~     MDI, PT008) relative to placebo MDI in adult subjects with mild to moderate persistent~     asthma.~   "
111689|NCT02105506|"~     Rationale: The construction of esophageal anastomoses is associated with considerable risk at~     postoperative anastomotic leakage. Application of TachoSil®, a tissue sealant with human~     fibrinogen and thrombin, can improve strength of the esophageal anastomosis and potentially~     prevent anastomotic leakage.~      Objective: Evaluation of feasibility and safety of TachoSil® application on esophageal~     anastomoses.~      Study design: Non-randomized, non-blinded, single-center intervention study. Study~     population: Patients, 18-80 years old, undergoing an elective total gastrectomy with an~     esophago-jejunostomy or esophagectomy with a planned esophagogastric anastomosis will be~     enrolled. A total number of 15 patients will be included in the study.~      Intervention: Gastric or esophageal resection will be executed according to the common~     procedures used in the UMC Utrecht. After construction of the esophageal anastomosis, all~     enrolled participants will receive a TachoSil® patch, which will be applied on the esophageal~     anastomosis intra-operatively. Hence, TachoSil® is used as an add-on therapy. TachoSil® will~     be degraded enzymatically in a period of approximately 24 weeks after application.~      Main study parameters/endpoints: The primary endpoint is feasibility, which is assessed by~     evaluation of adherence of the patch. A time-action analysis of the application of the~     Tachosil patch will be performed.~      Nature and extent of the burden associated with participation: The burden for the patient is~     minimal. The total surgical procedure will be prolonged with 10-15 minutes. Postoperative~     care and outpatient visits do not differ from regular protocol. TachoSil® is approved and~     registered for supportive treatment in surgery for improvement of haemostasis and to promote~     tissue sealing by the European Commission.~   "
111690|NCT02105493|"~     Trans-radial approach (TRA) has becoming popular and widely adopted over the last decade.~     However, radial artery occlusion (RAO) continues to be one of the limitation of trans-radial~     access and potentially limits the radial artery as an access site in the future. Several~     strategies have been used to decrease the incidence of RAO including the use of~     anticoagulation, maintenance of patency during hemostasis, or shortening the duration of~     compression. Currently, there is no data whether vasoactive pharmacological therapy such as~     nitroglycerin administered intra-arterially at the end of the procedure may reduce the~     incidence of RAO. It is hypothesized that the addition of nitroglycerin (nitric oxide donor)~     at the end of a TRA procedure may reduce the incidence of RAO.~   "
111691|NCT02105480|"~     The purpose of this double-blind pivotal clinical utility study is to determine on a large~     patient population whether heart murmurs can be reliably detected with high sensitivity and~     specificity using a locked, automated algorithm-based phonocardiogram analysis (also referred~     to as computer aided auscultation (CAA)).~      Each patient is auscultated and diagnosed independently by a medical specialist.~     Additionally, for each patient, an echocardiogram is performed as the gold-standard for~     determining heart pathologies. The CAA results are compared to the findings of the medical~     professionals as well as to the echocardiogram findings.~      Hypothesis: The specific (locked) CAA algorithms used in this study are able to automatically~     diagnose pathological heart murmurs in premature babies and newborns with at least the same~     accuracy as experienced medical specialists.~   "
111692|NCT02105467|"~     This was an efficacy and safety study of grazoprevir (MK-5172) in combination with elbasvir~     (MK-8742) in treatment-naive participants with chronic hepatitis C virus (HCV) genotype (GT)~     1, 4, or 6 infection. Participants were randomly assigned (3:1 ratio) to immediate treatment~     or deferred treatment (placebo control). The primary efficacy hypothesis was that the~     proportion of participants receiving combination therapy in the Immediate Treatment Arm who~     achieve sustained viral response at 12 weeks after the end of study treatment (SVR12) is~     superior to 73%.~   "
111693|NCT02105454|"~     In this study, participants with hepatitis C virus (HCV) genotype 1 (GT1) who failed prior~     direct-acting antiviral (DAA) therapy will receive Grazoprevir (MK-5172) + Elbasvir (MK-8742)~     + Ribavirin (RBV) to evaluate sustained virologic response (SVR) using this drug combination.~   "
111694|NCT02105441|"~     Do adults and children over 7 years of age with unilateral or assymetric hearing loss benefit~     from cochlear implantation on the worst hearing side.~   "
111695|NCT02105428|"~     A goal of this study is to use a novel methodology to determine whether insulin resistance in~     women with polycystic ovary syndrome (PCOS) is related to the accumulation of proteins with~     modifications. This could lead to future research to determine if these modifications~     interfere with their proper function. Additionally, the investigators will determine how~     protein quality is affected by exercise training. Aerobic exercise enhances the endogenous~     oxidant buffering systems which may minimize oxidative damage to proteins. The investigators~     propose that aerobic exercise minimizes the accrual of modified proteins by increasing the~     synthesis of new proteins, but also by increasing the degradation and removal of old and~     damaged proteins. Based on our previous studies the investigators observed that insulin~     affects plasma protein synthesis and aerobic exercise improves insulin sensitivity not only~     in muscle but also in liver. The investigators therefore propose that aerobic exercise and~     related increase in insulin sensitivity (and decline in insulin levels) will reduce~     accumulation of old and modified skeletal muscle and plasma proteins leading to improved~     function.~   "
111696|NCT02105415|"~     The hypothesis of this study is that a Ketamine / Propofol mixture will produce more stable~     hemodynamics as compared to Etomidate during emergent intubations in the intensive care unit.~     Patients that require a breathing tube to be placed in the ICU will be randomized to receIve~     either a Ketamine / Propofol mixture or Etomidate for sedation in order to place the~     breathing tube.~   "
111697|NCT02105402|"~     The purpose of this study is to carry out a high-level treatment efficacy study on children~     with speech sound disorders with motor speech involvement (SSD-MSI) using a well-controlled~     Randomized Controlled Trial design.~      The intervention of choice is the Prompts for Restructuring Oral Muscular Phonetic Targets~     (PROMPT) approach, which has been effective in treating motor speech disorders in adults and~     in children with autism and cerebral palsy.~   "
111700|NCT02105363|"~     The investigators want to determine how much the skin on the back can move left to right of~     the midline and also up and down, in subjects presenting for procedure or in healthy~     volunteers. The investigators will do measurements on the back using samples of individuals~     in all age groups.~      It is hypothesized that an explanation to late epidural failure could be related to excess~     back motion in individual subjects.~   "
111701|NCT02105350|"~     This is a phase I study (an early study to check the safety of a new drug or drug~     combination) to find the safest and most tolerated dose of the combination of oxaliplatin~     with gemcitabine and MEK 162 in patients with biliary cancer (including gallbladder cancers~     and cancers associated with the bile ducts leading from the gallbladder and to and from the~     liver) that is not curable by surgery and/or has spread beyond the biliary tree (place where~     cancer started). Everyone will receive the same standard doses of oxaliplatin and gemcitabine~     but may receive different doses of MEK 162.~      MEK 162 is a new drug which plays an important role in the regulation of cell growth and has~     been shown to shrink tumours in patients with biliary cancer and other types of human~     cancers. This type of drug has also been shown to shrink tumours when given in combination~     with cisplatin and gemcitabine in research studies done in animals and in some patients with~     biliary cancer.~   "
111702|NCT02105337|"~     The purpose of this study is to determine if a clear barrier placed over the eyes has any~     effect on goggle monitoring. When a patient has general anesthesia they lose the ability to~     blink and their eyes may dry. They may also lose the ability to keep their eyes fully closed.~     The anesthesiologist takes several steps to prevent injury to the eyes. First the eyes will~     be lubricated with ointment and the eyelids will be held in a closed position by the use of a~     clear barrier. During pituitary surgery it is the routine practice to perform many types of~     monitoring. One type of monitoring is to stimulate your eyes with a light. This helps your~     surgeon protect the nerve supply to your eyes. The light is supplied by a pair of goggles~     placed over your eyes during surgery.~      To help achieve our objective, the investigators are asking patients who are undergoing~     pituitary surgery to give us permission to record two sets of numbers form the monitoring~     device once prior to the application of the clear barrier and the second after the barrier is~     applied. This will be done when the patient is already asleep and will not be aware this is~     happening.~   "
111703|NCT02105324|"~     This study will test the hypothesis that a wearable automated bionic pancreas system that~     automatically delivers both insulin and glucagon can improve glycemic control vs. usual care~     for young people with type 1 diabetes ages 6-11 years old in a diabetes camp environment.~   "
111704|NCT02105311|"~     The investigators conduct this study to access the effect of selective laser trabeculoplasty~     on 24-hour circadian tension curves of patients with open-angle glaucoma, normal tension~     glaucoma and ocular hypertension. This treatment effect is compared with that of the~     prostaglandin analogue, travoprost.~   "
111705|NCT02105298|"~     Intraoperative intravenous fluid management practice varies greatly between~     anesthesiologists. Postoperative fluid based weight gain is associated with major morbidity.~     Postoperative respiratory complications are associated with increased morbidity, mortality~     and hospital costs. The literature shows conflicting data regarding intraoperative fluid~     resuscitation volume. No large-scale studies have focused on intraoperative fluid management~     and postoperative respiratory dysfunction.~      Hypotheses:~      Primary - Liberal intraoperative fluid resuscitation is associated with an increased risk of~     30 day mortality Secondary - Liberal intraoperative fluid resuscitation is associated with~     increased likelihood of postoperative respiratory failure, pulmonary edema, reintubation,~     atelectasis, acute kidney injury and peri-extubation oxygen desaturation.~   "
111706|NCT02105285|"~     The purpose of this study is to determine the efficacy and safety of OPC-1085EL ophthalmic~     solution in comparison with carteolol long-acting ophthalmic solution in subjects who are~     insufficiently responsive to carteolol long-acting ophthalmic solution.~   "
111707|NCT02105272|"~     The purpose of this study is to determine the efficacy and safety of OPC-1085EL ophthalmic~     solution in comparison with latanoprost ophthalmic solution in subjects who are~     insufficiently responsive to latanoprost ophthalmic solution.~   "
111708|NCT02105259|"~     The overall aim of this study is to develop and test a psychodynamic Internet--delivered~     psychological treatment for patients with social anxiety disorder and compare its efficacy to~     a waiting list.~   "
111709|NCT02105246|"~     The long-term goal of this research is to improve patient-centered outcomes in patients with~     coronary heart disease (CHD). CHD is the leading cause of death in the world. Exercise-based~     cardiac rehabilitation (CR) programs decrease mortality and improve quality of life in~     patients with CHD. Published guidelines recommend exercise-based CR following hospitalization~     for myocardial infarction, coronary artery bypass grafting, or percutaneous coronary~     revascularization, and referral to CR is one of nine performance measures established by the~     American Heart Association and American College of Cardiology for patients with CHD.~      Despite these compelling benefits, CR programs are vastly underutilized, with less than a~     third of eligible patients participating. The largest barrier to patient participation is~     that CR must be provided in a physician's office or hospital setting to qualify for~     reimbursement. For this reason, virtually all existing CR programs require that the patient~     travel to a CR center 3 times per week for 12 to 36 weeks. Unfortunately, many Americans live~     too far from a CR center to enroll, and even when nearby programs are available, many~     patients do not have the time, flexibility, transportation, social support, and/or financial~     resources to attend.~      One promising solution to the problem of CR under-utilization is greater implementation of~     home-based CR. Both home and center-based CR programs have equal benefits on cardiovascular~     risk factors and quality of life. However, similar efficacy does not necessarily translate~     into similar effectiveness. If patients are more likely to participate in home- vs.~     center-based therapy, then greater participation could lead to greater clinical~     effectiveness. We are therefore conducting a quasi-experimental, controlled trial at two VA~     medical centers to determine the comparative effectiveness of referral to home- vs.~     center-based CR in patients with CHD.~      Aim 1: Determine whether automatic referral to home- vs. center-based CR increases patient~     participation in CR after hospitalization for myocardial infarction or coronary~     revascularization.~      Aim 2: Among patients who choose to participate in CR, compare the effectiveness of home- vs.~     centerbased CR on six-minute walk distance, quality of life, and healthcare expenditures.~      Aim 3: Determine whether the effects of home vs. center-based CR differ by age, gender, race,~     ethnicity, employment, socioeconomic status, social support, comorbid conditions, or patient~     preference.~      Results from this study will (a) help policy makers determine the effect of covering home CR~     on healthcare expenditures in patients with CHD; (b) help providers understand the potential~     benefits and harms of home- vs. center-based CR; and (c) help patients answer questions like,~     Given my personal circumstances and preferences, which of these options will improve the~     outcomes most important to me.~   "
111721|NCT02105090|"~     The purpose of this study is to examine in prospective, double-blinded randomised manner the~     ability of novel articaine-containing lozenge to enhance the procedure related compliance~     (compared to placebo) of the adult patients undergoing upper gastrointestinal endoscopy.~   "
111722|NCT02105077|"~     The purpose of this study is to establish a laboratory method to determine from blood samples~     whether a person has been treated with xenon.~   "
111723|NCT02105064|"~     This is a study to evaluate the efficacy of rTMS for relief of obsessive-compulsive symptoms~     in patients with schizophrenia.~   "
111724|NCT02105051|"~     The purpose of this study is to establish Chinese neonatal network to investigate current~     situation of neonatal birth weight and related factors. We investigated the risk factors such~     as sex, gestational age, region, nation, altitude, place of residence, maternal occupation,~     education level of mother, maternal age, maternal pregnancy diseases and multiple births.~   "
111710|NCT02105233|"~     Prognosis in patients with glioblastomas (the most aggressive high-grade glioma) remains~     unfavourable. Tools for improving brain tumor surgery, in particular for gliomas, are~     increasing. There seems to be an agreement that achieving extensive resections, when done~     safely without jeopardizing neurological function, improves survival.~      Ultrasound is currently used as a tool for providing 2D or 3D images for the purpose of tumor~     localization and resection control. For the use in resection control the resection cavity is~     filled with saline to provide acoustic coupling between the ultrasound transducer and tissue.~     However, attenuation of acoustic waves is very low in saline compared to the brain and this~     difference in attenuation is the cause of artifacts that may severely degrade the ultrasound~     images. Such artifacts are seen as high-intensity signal at the resection cavity wall and~     beyond, potentially masking small tumor remnants and generally making the interpretation of~     images more difficult.~      This research group has developed an acoustic fluid intended for use in the resection cavity~     instead of saline. Tests in laboratory measurements have shown that the fluid reduces~     artifacts and has the potential to enhance ultrasound image quality in brain tumor surgery.~     The investigators expect that the acoustic fluid will make it easier to detect small tumor~     remnants near the end of an operation, thus increasing success of glioma surgery. The purpose~     of this study is to test the fluid during surgery for histopathologically proven glioblastoma~     to assess safety and efficacy.~   "
111711|NCT02105220|"~     The goal of this study is to describe the influence of the chest wall on the respiratory~     system mechanics in morbidly obese patients and in patients with high intra-abdominal~     pressure.~      The effects of increasing and decreasing positive end-expiratory pressure (PEEP) on chest~     wall and total respiratory system mechanics, lung volumes and gas exchange will be evaluated,~     both during controlled and assisted mechanical ventilation.~      Patients will be studied, first, during the acute phase of respiratory failure, when~     requiring intubation and controlled mechanical ventilation. Then, patients will be evaluated~     again during weaning from the ventilator to assess the influence of PEEP in assisted~     ventilation prior to extubation.~   "
111712|NCT02105207|"~     For patients presenting to the Emergency Department with acute dyspnea, emergency physicians~     will be asked to categorize the diagnosis as acute decompensated heart failure or~     non-cardiogenic shortness of breath a) after the initial clinical assessment, and b) after~     performing lung ultrasound (LUS) for LUS arm or after chest radiography (CXR) and natriuretic~     peptide (NT-pro BNP) results for CXR arm. All patients will undergo CXR, those enrolled in~     the LUS arm, after sonographic evaluation. After discharge, the cause of patient's dyspnea~     will be determined by independent review of the entire medical records performed by two~     emergency physicians. In case of disagreement, a third expert physician will review entire~     medical records, and adjudicate the case.~   "
111713|NCT02105194|"~     Chart review of patients who received hyperbaric oxygen therapy for cerebral decompression~     illness who also underwent SPECT brain blood flow imaging to see if SPECT brain imaging~     tracks and is consistent with the clinical condition of the patients.~   "
111714|NCT02105181|"~     Endoscopic treatment of benign biliary strictures can be challenging. Balloon dilation and/or~     plastic stent placement are currently the most popular techniques. Partially covered~     self-expandable metallic stents have also shown to be effective but can be difficult to~     remove. A novel fully covered metallic stent has recently been developed.~      The aim of this study was to prospectively evaluate the placement of fully covered~     self-expandable metallic stents (FCSEMS) in this setting.~   "
111715|NCT02105168|"~     Lung Cancer and melanoma relapsed frequently whereas its very sensitive to treatment such as~     chemotherapy or radiotherapy. The purpose of this study is to have a better understanding of~     why those patients are relapsing using next generation sequencing to identify rare mutations~     and assessed their predictive value.~   "
111716|NCT02105155|"~     The best period for the conversion from Prograf (tacrolimus administered twice daily) to~     Advagraf (once-daily prolonged-release tacrolimus) remains unknown. The aim of this~     prospective, randomized, multicenter trial is to prove the non-inferiority of the early~     conversion (at D7) versus the conversion at D90 after liver transplantation. The primary~     objective will be to evaluate the incidence of a first biopsy-proven acute rejection in the 6~     first months, and prove the non-inferiority of the conversion at D7 + / - 3 versus the~     conversion at D90 + / - 5 (reference group). If non-inferiority is proved, the two strategies~     will be compared in terms of superiority. 250 patients will be included. Three ancillary~     studies will be added : a PK study in a subgroup of 40 patients (20 patients per arm), an~     assay of the calcineurin activity on a subgroup of 40 patients, and a medicoeconomic study in~     all patients~   "
111717|NCT02105142|"~     Attention-deficit hyperactivity disorder (ADHD) is the most common neurobehavioral disorder~     of childhood, affecting approximately 8% of youth. Children with ADHD often have problems~     sustaining attention and completing multi-step commands and tasks of daily living, such as~     homework. Pediatricians are often the first physicians to identify problems with children's~     functioning at home and at school. However, because of limited visit time, pediatricians~     often struggle with managing ADHD while trying to also cover a vast array of other primary~     care issues. Moreover, as there is a nationwide shortage of pediatric mental health~     specialists and access to parenting programs is limited, a critical need exists to develop~     interventions that form partnerships between behavioral and mental health specialists and the~     primary care pediatrician. One approach is to base interventions in the pediatric clinic to~     ensure children have access to appropriate treatment. Thus far, only a limited number of~     sites have this pediatric-mental health partnership.~      Health information technology (HIT) has been used to enhance primary care management of ADHD.~     HIT can improve pediatricians' ability not only to adhere to recommended guidelines, but also~     to screen for co-existing disorders and provide timely parental education. An alternative~     strategy might be to use group visits (GV). GV afford more time with families and allows the~     pediatrician to facilitate more in-depth discussions. More importantly, the group model~     allows parents to learn from one another, normalizes parenting expectations, and addresses~     shared experiences of medication side effects and other factors related to adherence.~     Moreover, a group visit can be conducted in a physical location, such as the pediatric~     clinic, or be brought into the virtual world with the aid of social media. Virtual support~     groups for chronic care diseases have become an increasingly popular way for a community of~     individuals to exchange information and offer emotional support.~      Prior to the adoption of these interventions into primary care practice, investigators must~     know which is best. Rigorous comparative effectiveness research (CER) can help to determine~     this. This proposal will compare a HIT based intervention to a GV strategy, with and without~     the use of social media. These 3 interventions will be compared based not only on clinical~     measures of interest but also on parent-defined patient outcomes. Prior research has largely~     focused on measuring clinical outcomes such as treatment adherence and ADHD symptom reduction~     with little emphasis on understanding how patient-centered outcomes, such as the quality of~     life of families dealing with ADHD, are affected.~      Building on previous work, the specific aims for this study are:~      Aim 1. Compare the preliminary efficacy of three interventions to improve treatment of ADHD~     in the primary care setting Aim 1a) Compare the effectiveness of the three interventions on~     clinical measures such as parent and teacher rated ADHD symptoms and adaptive functioning Aim~     1b) Compare the effectiveness of the three interventions on patient-centered outcomes such as~     quality of life and parental satisfaction with the intervention The three interventions will~     be: 1) Child Health Improvement through Computer Automation (CHICA) which is the health~     information technology innovation arm; 2) Group visits (GV); or 3) Group visits plus online~     discussion portal (GV+DP).~   "
111718|NCT02105129|"~     The primary objective of this study is to assess the safety and tolerability of a single dose~     of up to 800 mg in Part A (evaluated in planned steps of 5, 20, 50, 100, 200, 300 mg under~     fasted conditions, followed by 300, 400, 600 and 800 mg HMPL-523 under fed conditions of a~     standard meal, followed by multiple doses of 200, 300, 400 and 500 mg of HMPL-523 in Part B,~     in healthy male volunteers.~      The secondary objective is to determine the pharmacokinetic profile of single (Part A) and~     multiple (Part B) oral doses of HMPL-523 in healthy male volunteers and to determine the~     preliminary effect of food (Part C）~   "
111719|NCT02105116|"~     This pilot clinical trial studies if cells donated by a close genetic relative can help keep~     acute myeloid leukemia (AML) from coming back after standard chemotherapy induces a complete~     remission. Blood cells obtained from a donor include a variety of blood cells that may~     trigger the patient's immune system to react against AML cells.~   "
111720|NCT02105103|"~     Accu-Chek® Insight Insulin Pump EU Study is a Multicenter Study to evaluate the Accu-Chek®~     Insight Insulin Pump in routine practice. This is an open-label, prospective, multinational,~     multicenter study evaluating the CSII therapy with the Accu-Chek Insight Insulin pump in~     routine practice in adult subjects with Type 1 or type 2 diabetes. Subjects must have been on~     intensive insulin therapy for at least six months i.e. either on CSII or MDI. All subjects~     will receive training in the preparation, programming and daily use of the Accu-Chek Insight~     Insulin pump. In addition, subjects previously on MDI may receive more training in order to~     be comfortable with the use of an insulin pump. The study will be conducted in 10-12 sites in~     Austria, France and the United Kingdom. A total of 80-95 subjects will be enrolled in this~     study.~   "
111731|NCT02104960|"~     This study aims to evaluate skin aging of an homogeneous population of 77 years old patient~     selected among the PROOF cohort who has been continuously investigated by cardiological~     examination.~      Skin aging will be explored by macroscopic and microscopic evaluation. In particular, skin~     aging will be measured by an index of clinical aging (SCINEXA) and other complementary~     measures such as facial photos, standard and High Definition dermoscopy, elastography,~     sebumetry, in vivo and ex vivo confocal microscopy, and classical histological examinations.~   "
111732|NCT02104947|"~     Evaluate the reversal of the anticoagulant effects of dabigatran by IV administration of 5.0g~     idarucizumab in patients treated with dabigatran etexilate who have uncontrolled bleeding or~     require emergency surgery or procedures.~   "
111733|NCT02104934|"~     Total knee arthroplasty or replacement (TKA), a commonly performed surgery for osteoarthritis~     of the knee, is a painful procedure and requires a multimodal analgesic approach. A method~     for analgesia is local infiltration analgesia (LIA), where a mixture of drugs is injected~     around the knee joint.~      Adductor canal block (ACB) is an alternative regional anaesthesia technique which has been~     shown to result in minimal thigh weakness.~      The investigators aim to study if the analgesia provided by ACB is superior to LIA while~     preserving quadriceps strength.~   "
111734|NCT02104921|"~     This study is utilizing ultrasound measurement to measure neuromuscular disease status in~     adult patients. The hypothesis is the by quantifying ultrasound data, it is possible that~     ultrasound can be utilized as a tool to determine if a disease is responding to therapy or~     progressing.~   "
111735|NCT02104908|"~     The investigators aim to examine target-controlled propofol infusion as a technique of~     anesthesia for surgery of hip fracture under ultrasound guidance lumbar and sacral plexus~     block or lumbar, sacral and paravertebral nerve block in the elderly; and to evaluate which~     regional anesthesia was more sufficient for the old.~   "
111736|NCT02104895|"~     The aim of this Phase 3 randomised trial is to compare the efficacy and safety of whole~     breast radiotherapy to accelerated partial breast irradiation using intensity-modulated~     radiotherapy technique in selected early breast cancer patients after breast conserving~     surgery.~   "
111737|NCT02104882|"~     Glioblastoma multiforme (GBM) is a disease with an extremely poor prognosis. Despite surgery~     and radiochemotherapy, the tumors are likely to grow back very quickly.~      Intraoperative radiotherapy (IORT) may improve local control rates while sparing healthy~     tissue (Giordano et al. 2014). IORT takes place before cranioplasty directly after gross (or~     subtotal) tumor resection. Several past studies on IORT for GBM conducted in Japan and Spain~     have yielded encouraging results (Sakai et al. 1989; Matsutani et al. 1994; Fujiwara et al.~     1995; Ortiz de Urbina et al. 1995).~      However, the full potential of the procedure is to date largely unexplored as most previous~     studies used forward-scattering (electron-based) irradiation techniques, which frequently led~     to inadequately covered target volumes. With the advent of the spherically irradiation~     devices such as the Intrabeam® system (Carl Zeiss Meditec AG, Oberkochen, Germany), even~     complex cavities can be adequately covered with irradiation during IORT. However, there is no~     data on the maximum tolerated dose of IORT with low-energy X-rays as generated by this~     system.~      The INTRAGO I/II study aims to find out which dose of a single shot of radiation, delivered~     intraoperatively direct after surgery, is tolerable for patients with GBM. A secondary goal~     of the study is to find out whether the procedure may improve survival rates.~   "
111738|NCT02104869|"~     This will be an open label, parallel, randomized clinical trial that will evaluate the~     immunogenicity and safety of the trivalent influenza vaccine (inactivated and fragmented)~     produced by Instituto Butantan among adult kidney transplant recipients, when administered in~     three vaccination regimens: i) the recommended dose; ii) a single double dose; iii) two doses~     administered with a 21 day interval.~      The randomization ratio among the three groups of kidney transplant recipients will be 1:1,~     and 60 participants will be included in each group. After vaccination all participants will~     be followed for 26 weeks.~      In addition, 15 healthy adults will be included as a control group, and will receive the~     recommended dose.~      The study hypothesis is that a different vaccination regimen can improve the immune response~     of kidney transplant recipients after vaccination with the trivalent influenza vaccine~     (inactivated and fragmented).~   "
111739|NCT02104856|"~     The primary objective of this Registry is to collect real-world data on patients undergoing~     bronchial thermoplasty (BT) treatment.~   "
111740|NCT02104843|"~     The primary purpose is to assess the effect of Daclatasvir (DCV)/Asunaprevir (ASV)/BMS-791325~     combination therapy on the exposure of Rosuvastatin.~   "
111741|NCT02104830|"~     The purpose of the study is to compare safety and efficacy of a single dose of~     empegfilgrastim and daily dosing of filgrastim for prevention of neutropenia in patients~     receiving AT (docetaxel 75 mg/m2 + doxorubicin 50 mg/m2).~   "
111742|NCT02104817|"~     The study is a randomized, double-blind, placebo-controlled (corn oil), parallel group design~     that will enroll approximately 13,000 patients with hypertriglyceridemia and low HDL and high~     risk for CVD to be randomized 1:1 to either corn oil + statin or Epanova + statin, once~     daily, for approximately 3-5 years as determined when the number of MACE outcomes is reached.~   "
111743|NCT02104804|"~     A Multicenter, Randomized, Double-Blind, Phase 3b Trial to Evaluate the Efficacy and Safety~     of Saxagliptin Added to Insulin Monotherapy or to Insulin in Combination with Metformin in~     Chinese Subjects in China with Type 2 Diabetes Who Have Inadequate Glycaemic Control on~     Insulin Alone or on Insulin in Combination with Metformin~   "
111744|NCT02104791|"~     It is hypothesized that the procalcitonin has a role to play in prediction of intra-amniotic~     subclinical infection.~   "
111745|NCT02104778|"~     The aim of the present study is to test that adding dexamethasone or epinephrine~     significantly prolongs the duration of sciatic nerve blocks with ropivacaine and that the~     magnitude of the effect differs among dexamethasone and epinehrine.~   "
111746|NCT02104765|"~     The main purpose of this study is to evaluate the safety of the study drug known as LY2951742~     in healthy Japanese and Caucasians. The study will also investigate how the body processes~     the drug and how the drug affects the body. The study is expected to last about 5 to 7~     months, depending on the arm.~   "
111747|NCT02104752|"~     The investigators propose to test whether curcumin nanoparticles will improve behavioral~     measures and biomarkers of cognition and neuroplasticity in patients with schizophrenia who~     are already receiving a stable dose of antipsychotic.~   "
111750|NCT02104713|"~     This study will determine the safety of allogeneic stem cell therapy from healthy donors, for~     2nd degree burn wounds of less than 20% Total Body Surface Area (TBSA), at four different~     dose levels.~      Clinical evaluation will take place every 1 to 4 weeks intervals until wound closure, and~     then monthly for 6 months following the last administration of MSCs.~      Once the safety and dose-response analysis in Phase 1 is completed, an expanded trial will be~     initiated to better examine the efficacy of MSC therapy in 2nd degree burn wounds. Phase 1~     will establish the maximum safe dose that will be used in the Phase II trial.~   "
111751|NCT02104700|"~     The study will be an open-label, pilot study in virologically suppressed patients comparing~     the efficacy, safety and tolerability of two Antiretroviral regimen strategies:~      Arm A: Immediate switch Rilpivirine/Emtricitabine/Tenofovir (single tablet formulation~     (STF))at randomization~      Arm B: Delayed switch Continue Nevirapine/Lamivudine/other Nucleoside reverse transcriptase~     inhibitor (NRTI)through 24 weeks then switch to STF of Rilpivirine/emtrictabine/tenofovir and~     followed through 48 weeks.~   "
111752|NCT02104687|"~     The purpose of the study is to confirm the hypothesis that flow treatment algorithm based on~     cardiac index trending by transesophageal Dopplerometry would result in reduced complications~     and reduced length of hospital stay in major abdominal surgery patients, when compared to~     patients treated with press treatment algorithm.~   "
111753|NCT02104674|"~     This Phase III, randomized, double-blind, placebo-controlled, multicenter study will assess~     the efficacy and safety of lebrikizumab in adult patients with mild to moderate asthma~     treated with short-acting beta-agonist (SABA) therapy alone. Patients will be randomized in a~     1:1:1 ratio to receive either blinded lebrikizumab or placebo treatment by subcutaneous (SC)~     injection (every 4 weeks for a total of 3 doses) or open-label treatment with Singulair~     (Montelukast; 10 mg daily). Time on study treatment will last 12 weeks.~   "
111754|NCT02104661|"~     People with multiple sclerosis (MS) have nerve loss even without acute inflammatory relapses,~     as obvious in the progressive phase of disease. Drugs that may prevent nerve loss work better~     in earlier stages when it is difficult to measure progressive disability. But it is now~     possible to measure the nerve loss as neurofilament light (NFL) in the cerebrospinal fluid~     (CSF). This is a trial of a neuroprotective drug, oxcarbazepine, which showed benefit in an~     animal model of multiple sclerosis. The investigators will use an innovative outcome, a~     reduction in the content of NFL in the CSF, as well as the usual clinical disability and~     imaging methods, to measure the success of the oxcarbazepine as a neuroprotective agent in~     MS. The use of NFL, a surrogate marker of neurodegeneration, allows a blinded and accurate~     outcome.~   "
111755|NCT02104648|"~     This is a 2 part study to evaluate the safety and tolerability of supra-therapeutic doses of~     RO4602522 (Part A); and to investigate the effect of RO4602522 on the QTcF interval in~     healthy volunteers (Part B). Part A of the study will be a multiple-dose, randomized,~     double-blind, placebo-controlled study. Participants will be randomized to receive daily,~     oral doses of either RO4602522 or placebo for ten days. Part B of the study will be a~     multiple-dose, randomized, double-blind, double-dummy, placebo controlled, positive-control,~     parallel group study. Participants will be randomized to receive either multiple or single~     doses of RO4602522 or to receive single doses of moxifloxacin for 11 days. Pharmacokinetic~     parameters will be assessed for Parts A and B; and continuous ECG recordings will be made~     during Part B.~   "
111756|NCT02104635|"~     This research represents a randomized trial of a program to improve timely postnatal care,~     comparing post-natal check-ups performed by community health workers delivered either by~     phone or in person to a control group. The study hypothesis is that when community health~     workers check on women three days after their delivery we will see improvements in the~     detection of maternal and child complications, better knowledge of complications and an~     increase in behaviors that are expected to lead to improved maternal and child health.~   "
111757|NCT02104622|"~     Many people with spinal cord injury are no longer able to walk and must use wheelchairs for~     mobility. These individuals experience greater rates of depression and lower quality of life.~     Many of these individuals express a strong desire to walk again, and report many psychosocial~     benefits to being eye to eye with peers in social interactions. Additionally, wheelchairs~     allow only limited community access, creating an additional obstacle to seeking out~     meaningful social roles in the community. Currently, there is new technology called robotic~     exoskeletons that would allow people with spinal cord injury to walk. These robotic~     exoskeletons also allow for curb, ramp, and stair negotiation, which are critical to~     community access. Current research has examined training with robotic exoskeletons indoors~     over level surfaces in clinical settings. This study will examine the potential for everyday~     use, including ramps, stairs, curbs and indoor and outdoor use.~   "
111758|NCT02104609|"~     The purpose of this study is to determine the effects of obesity on the pharmacokinetics of~     the levonorgestrel (LNG) only emergency contraceptive (EC) regimen and on markers of~     ovulation~      Primary hypothesis:~      1) Obese users of LNG-EC have a pharmacokinetic profile that is consistent with a larger~     volume of distribution of LNG.~      Secondary hypothesis:~        1. Alterations in these pharmacokinetic parameters of the LNG-EC regimen in obese women~          affect the primary mechanism of action, which is inhibition of ovulation.~        2. Obesity may affect other factors that alter levels of LNG, such as sex-hormone binding~          globulin (SHBG) and albumin, which bind LNG and potentially lowers the amount of free~          LNG.~   "
111759|NCT02104596|"~     Hypothesis: Intraarticular injections of isotonic Xylitol solution will improve pain in~     patients with knee osteoarthritis (OA).~   "
111760|NCT02104583|"~     This study is to evaluate the effect of eleclazine (GS-6615) compared to placebo on the~     overall occurrence of appropriate implantable cardioverter-defibrillator (ICD) interventions~     (antitachycardia pacing [ATP] or shock) in adults with ICD or cardiac resynchronization~     therapy-defibrillator (CRT-D).~   "
111761|NCT02104570|"~     The purpose of this study is to investigate the effects of Kinesio Taping on the position~     sense of shoulder after muscle fatigue.~   "
111762|NCT02104557|"~     Post Marketing Surveillance To Observe Safety And Efficacy Of Sayana® Used For Contraception~     And Management Of Endometriosis-Associated Pain~   "
111838|NCT02103556|"~     The purpose of this study was to evaluate the effect of olive oil and flaxseed oil in the~     treatment of constipation of patients undergoing hemodialysis.~   "
111767|NCT02104492|"~     Multiple sclerosis (MS) is the most common inflammatory demyelinating chronic disease of the~     central nervous system and the second leading cause of disability in young adults. Motor~     deficits also involve respiratory muscles. This involvement is present from early stages of~     disease and is frequently dismissed by professionals until advanced stages of disease. The~     effect of a training program of respiratory muscles is not sufficiently studied. The aim of~     this research is to assess the clinical and functional response of a 12-week respiratory~     muscles training program (RMTP) for persons with relapsing-remitting multiple sclerosis~     (RRMS).~      This study is consisted with two sub research:~      Firstly, a single-blind randomized clinical trial will be carried out in 40 persons with~     RRMS. Participants either will be received (n = 20) peripheric resistive muscle training~     program which will be supplemented by a 12-week Respiratory Muscles Training Program (RMTP)~     with ORYGEN Dual® device for 50 minutes, twice a week during three months or (n = 20) they~     will be received peripheric resistive muscle training program and health education program.~     Main outcomes will be strength of the respiratory muscles assessed by maximal inspiratory and~     expiratory pressure measurements (MIP and MEP). The secondary outcomes will be assessed the~     quality of life (MSQOL-54), walking speed (T25-FW, MSWS-12 and Hauser ambulatory index),~     fatigue (MFIS), endurance of the respiratory muscles (10RM) manoeuvre and peripherical muscle~     strength (Multiple-Sit-to-Stand Test and handgrip strength).~      Secondly, the qualitative research where researchers will interview participants about their~     interest in carrying out the intervention (difficulties and advantages) and identify themes~     of interest about changes in quality of life.~   "
111768|NCT02104479|"~     Diagnostic accuracy of biomarker testing (galactomannan (GM), (1~   "
111769|NCT02104466|"~     Peripheral neuropathy is a common complication of diabetes, and one of the strongest~     determinants of reduced health-related quality of life among people with diabetes. Neuropathy~     frequently presents with painful symptoms, activity limitation, insomnia, fatigue, and~     depressive symptoms. Anti-convulsants and tricyclic anti-depressants provide at least~     moderate pain relief for 25-50% of patients with painful diabetic neuropathy (PDN), but often~     decrease other domains of quality of life through adverse effects, such as dry mouth,~     dizziness, nausea, drowsiness, and urinary problems. Effective, non-pharmaceutical approaches~     for PDN are needed, particularly for low income and racial/ethnic minorities who are at~     highest risk of diabetes and related complications. Acupuncture is a promising treatment for~     PDN, but evidence is limited. To address the significant public health need related to pain~     management among underserved people with diabetes, this study proposes an innovative,~     group-based model of acupuncture for PDN at an urban safety net hospital. Sixty patients who~     have PDN will be enrolled and randomized to one of three arms: (a) usual care combined with~     12 weeks of group acupuncture twice weekly, (b) usual care combined with 12 weeks of group~     acupuncture once weekly, or (c) usual care alone (20 in each group). The aims of the study~     are to determine the feasibility of group acupuncture for PDN among underserved patients with~     diabetes; to evaluate the preliminary treatment effects of group acupuncture on pain,~     health-related quality of life, depressive symptoms, sleep disturbance, nerve conduction~     velocity, and protective sensation; and to determine the optimal frequency of acupuncture~     treatments.~      The investigators hypothesize that compared to patients receiving usual care alone, patients~     who undergo weekly group acupuncture treatments will have:~        1. decreased pain intensity~        2. improved health-related quality of life~        3. improved sural nerve conduction velocity~   "
111770|NCT02104453|"~     One-handed E-C clamp mask holding technique, two-handed mask ventilation with jaw thrust, and~     two-handed mask ventilation with triple airway maneuver are three common airway management~     maneuvers. Sniffing position may improve ventilation between these three maneuvers. The~     investigators hypothesize that ventilation efficiency may be different between these three~     maneuvers whether the patient is in sniffing position or neutral position. The investigators~     would like to quantify this effect by measuring the expired tidal volume, airway pressure,~     EtCO2 slope and hemodynamic change between these three maneuvers during anesthesia induction.~   "
111771|NCT02104440|"~     The purpose of this study is to evaluate the safety and efficacy of the sequential infusion~     of allogeneic mesenchymal stem cells (MSC), expanded in vitro with platelet lysate without~     addition of animal products in the treatment of patients undergoing allo-HSCT who developed~     one or more cytopenias.~   "
111772|NCT02104427|"~     This is a phase II study to evaluate the efficacy and safety of TG-0054 combined with G-CSF~     in mobilizing hematopoietic stem cells in patients with multiple myeloma, non-Hodgkin~     lymphoma or Hodgkin disease.~   "
111773|NCT02104414|"~     The purpose of this study is to compare the quality and duration of pain relief after a~     hemorrhoidectomy, provided by locally administered liposomal bupivacaine versus bupivacaine~     hcl or control with saline. It is hypothesized that liposomal bupivacaine will provide more~     effective postoperative pain relief than both bupivacaine hcl and the control.~   "
111774|NCT02104401|"~     This research will help us to understand whether transcranial direct current stimulation~     (tDCS) can safely improve recovery of speech and language abilities, gait , and mood in~     people with Parkinson's disease and related disorders. Some of the disorders that will be~     studied to understand if tDCS can be useful include Parkinson's Disease, Multi-System Atrophy~     (MSA) and progressive supranuclear palsy (PSP).~   "
111775|NCT02104388|"~     The purpose of the study is to determine if SJP-0035 ophthalmic solution is effective in~     promoting corneal epithelial wound healing in conditions associated with corneal epithelial~     disorders.~   "
111776|NCT02104375|"~     Cardiovascular disease (CVD) continues to be the major cause of morbidity and mortality in~     western countries. It has been shown that CVD events are known to be higher in the winter~     than in the summer. Low environmental temperatures may induce increased cardiovascular stress~     resulting in cold-induced hypertension (CIH), the leading risk factor for CVD events. Similar~     to whole-body cold exposure, the cold pressor test (CPT), an external local cold stimulus,~     has been used for evaluation of cardiovascular and hemodynamic reactivity to sympathetic~     stimulation. It has been shown that brachial blood pressure (BP), pressure pulse wave~     reflection, aortic BP, heart rate (HR), and arterial stiffness are increased during CPT.~     However, the physiologic mechanisms for the cardiovascular complications related to low~     temperatures are not completely clear.~      Isometric-handgrip (IHG) exercise has been used as a tool for assessing cardiovascular~     autonomic control by a maneuver defined as post-exercise muscle ischemia (PEMI). PEMI induces~     exercise pressor reflex (metaboreflex) by trapping metabolites in the previous active muscle~     at the cessation of exercise. During PEMI, the accumulation of contraction-derived~     metabolites induces sympathetic mediated vascular stimulation and an increased BP, whereas~     the HR fully recovers. This suggests that the fall in HR is evoked by an increase in~     parasympathetic activity which overpowers the sympathetic activation. Implication of IHG~     exercise followed by PEMI provides important clinical information because impaired autonomic~     and cardiovascular functions are associated with cardiovascular events.~      Recently, oral supplementation with the amino acid L-citrulline (L-cit) has been proposed as~     a possible adjunct treatment for hypertension and arterial stiffness. L-cit is known to~     enhance the bioavailability of L-arginine (L-arg), the endothelial substrate for nitric oxide~     (NO) production. Cold exposure might include a temperature-dependent inhibition of~     endothelial NO synthase (eNOS), the enzyme that produces NO from the amino acid L-arg and may~     trigger various types of CVD. It has been shown that L-cit supplementation has effectively~     attenuated the CIH response during cold pressor test. Thus, L-cit supplementation may be~     effective to reduce the cardiovascular responses associated with cold exposure and the~     exercise pressor reflex imposed by PEMI. Therefore, the proposed study is important for the~     following reasons: (1) the results of his study will add to our understanding regarding the~     cardiovascular and autonomic mechanisms associated with exercise and cold exposure; (2) the~     results of this study will contribute to the development of an adjunct therapy for the~     prevention of cardiovascular adverse events that are particularly increased during stress~     such as cold exposure and exercise.~   "
111777|NCT02104362|"~     Recently, HDR brachytherapy delivering only a 19 Gy fraction was proposed as exclusive~     treatment for low and intermediate risk prostate cancers. With a median 3-year follow-up, the~     Spanish team reported a biochemical control rate of 100% and 87%, respectively, for low risk~     and intermediate risk tumors. In parallel with these encouraging results regarding~     biochemical control, the authors described excellent urinary and digestive tolerance, notably~     the absence of grade > 2 complications. However, it should be noted, in this study, that~     special protection was provided to the anterior aspect of the rectum by means of a 10 ml~     transperineal injection of hyaluronic acid into the prostate-rectal interspace.~      The idea of using a single high dose (in one fraction) was proposed at the MSKCC by the team~     of Fucks et al. which, in 2008, following a median 18-month follow-up, published a a 90%~     local control rate for spinal metastases after a single dose at 18 to 24 Gy.~      The aim of the present study is to analyze acute urinary and digestive toxicity (< 180 days)~     observed following interstitial high dose rate prostate brachytherapy delivering a total dose~     of 20 Gy in one fraction.~   "
111778|NCT02104349|"~     The objective of this study is to evaluate the effect of mindfulness meditation technique on~     post-operative pain of spine surgery subjects. Subjects will participate in a 6-week~     mindfulness meditation program, beginning two weeks prior to spine surgery. The investigators~     are interested in determining if this intervention improves the ability to tolerate pain and~     reduces anxiety, thus reducing the need for prescribed analgesics and narcotics. The~     meditation intervention will be compared against a control group consisting of subjects that~     will undergo music therapy during the same period of time.~   "
111779|NCT02104336|"~     Treatment of Pediatric Subjects with Pearson syndrome~   "
111780|NCT02104323|"~     1)Preliminarily evaluate the treatment effect of continuous vein injection of recombinant~     human endostatin on NF2; 2)Preliminarily evaluate the safety and the patient's tolerance of~     the treatment of endostatin; 3)Provide an objective basis for an enlarged randomized~     double-blind trial.~   "
111781|NCT02104310|"~     For most brain tumors, radiation treatment is guided by a Magnetic Resonance Imaging (MRI)~     scan. In this study, information from a special scan, called a Positron Emission Tomography/~     Computed Tomography (PET/CT) scan using an amino acid called~     Fluorine-18-L-dihydroxyphenylalanine (18F-DOPA) will also be used to image the tumor and~     guide your radiation oncologist in determining locations to treat with radiation. This type~     of scan has shown promise in being able to better distinguish tumor from normal brain tissue~     and may help to more accurately plan radiation treatment. This type of scan can also assist~     the radiation oncologist in identifying the most aggressive regions of the tumor. The goal of~     this study is to use the 18F-DOPA PET/CT scan to help determine where the disease is that~     needs to be treated with radiation, in order to improve the effectiveness of radiation in~     this tumor.~   "
111782|NCT02104297|"~     To compare the effect of two different agents deksmedetomidine, remifentanil and placebo,~     agitation and recovery condition, on nasal septum operation.~   "
111783|NCT02104284|"~     Asthmatic patients and non-asthmatic controls were recruited prospectively from four referral~     hospitals in Korea. Participants were challenged with each of methacholine and mannitol~     inhalation on different days. Their diagnostic utility was evaluated by calculating their~     sensitivity and specificity for asthma diagnosis. Response-dose-ratio was also compared.~   "
111784|NCT02104271|"~     There is a wide variability of options for treatment of chronic radiation proctitis. However,~     studies are still limited, usually case reports from a single center and few are comparative~     studies between methods. Therefore, the choice of treatment is determined by availability and~     local expertise for each method. The variability of treatment options range from~     anti-inflammatory medical treatment, sucralfate, short chain fatty acids, antioxidants and~     hyperbaric oxygen to such endoscopic and surgical treatments. Surgery is usually the last~     therapeutic option due to the high morbidity and mortalityassociated. Various endoscopic~     treatment modalities have been reported. Formalin topic is effective in up to 48% of patients~     with chronic radiation proctitis.~      The endoscopic treatment with argon plasma (APC) is low cost, easy to apply and~     transportation, safe and effective in the treatment of rectal bleeding in patients with~     chronic radiation proctitis. Currently, the APC is the preferred endoscopic modality.~      Most studies on the use of APC in radiation proctitis showed benefit. The APC controls the~     mild to moderate rectal bleeding in 80% to 90% of cases and improves symptoms of urgency,~     diarrhea and tenesmus in 60% to 75% of cases.~   "
111785|NCT02104258|"~     The purpose of the study is to compare the effect of two rehabilitation protocols with~     different emphasis on eccentric exercises after acute hamstring muscle strain injuries on the~     time to return to sports (RTS) and the rate of re-injuries in male athletes.~      The hypothesis is that the addition of early eccentric hamstring exercises being performed at~     longer muscle-tendon length towards end range of motion alter the outcomes RTS and~     re-injuries in a rehabilitation protocol after acute hamstring muscle strain injuries.~   "
111786|NCT02104245|"~     This study (ARD-3150-1202, ORBIT-4) will evaluate the safety and efficacy of inhaled~     Pulmaquin (ciprofloxacin dispersion for inhalation) compared to inhaled placebo in subjects~     who have a confirmed diagnosis of non-cystic fibrosis (non-CF) bronchiectasis with a history~     of pulmonary exacerbations and chronic P. aeruginosa infections.~   "
111787|NCT02104232|"~     Background The rates of perinatal depression in South Asian women are reported to be amongst~     the highest in the world, ranging from 18%-30% in urban areas and 28%-36% in rural areas. In~     addition to its profound impact on women's health, disability and functioning, perinatal~     depression is associated with poor child health outcomes such as pre-term birth, infant~     under-nutrition and stunting. There is robust evidence that perinatal depression can be~     effectively managed with psychological treatments delivered by non-specialist health care~     workers. The Thinking Healthy Program (THP), a psychological treatment delivered by community~     health workers (CHWs) in Pakistan, more than halved the rate of perinatal depression among~     mothers and led to significant improvements in child health outcomes. To enhance access to~     such evidence-based psychological treatments there is a need to examine the potential role of~     other human resources such as lay persons in delivering psychological treatments such as THP~     in poor resource settings.~      Objective To evaluate the effectiveness and cost-effectiveness of THP delivered by peers (the~     Thinking Healthy Program-Peer delivered in Goa, India; THPP-I) over the duration of 6 months.~     Peers will be healthy mothers who live in the same community as potential trial participants~     (TPs).~      Study design and outcomes Individual randomized controlled trial in Goa, India involving 280~     women. TPs will not be blinded to treatment allocation. Mothers attending antenatal clinics~     at hospitals will be assessed for eligibility to participate in the trial (e.g. whether they~     are in the second or third trimester of pregnancy). Those who are eligible will be invited to~     participate in screening for depression; mothers who consent will be screened for depression~     with a locally validated version of the Patient Health Questionnaire (PHQ-9). Women who~     screen positive (PHQ-9 score ≥ 10) and give informed consent for further participation in the~     trial will be randomly allocated in a 1:1 ratio to receive enhanced usual care (EUC) or~     THPP-I+EUC, using a computer generated allocation sequence. The primary outcomes will be~     remission (i.e. recovery from depression and depressive symptoms), both assessed by the PHQ-9~     at 6 months. Secondary outcomes are depressive symptoms and remission at 3 months (PHQ-9),~     maternal disability at 3 and 6 months (measured with the WHO-DAS), perceived social support,~     breastfeeding rates and infant weight and height of children at 3 and 6 months. Outcomes will~     be analyzed on an intention to treat basis.~      Interventions EUC will comprise communicating the results of the screening to the mother~     through an information sheet on self-care for mental health, communicating the results to the~     mother's gynaecologist, providing the gynaecologist with the WHO mhGAP guidelines for the~     treatment of depression, and providing guidance on referral of depressed mothers to mental~     health services. TPs who are in the THPP-I group will receive, in addition to EUC, between 6~     to 14 sessions of THPP starting from their recruitment in the second/ third trimester until~     up to 6 months after child birth. Sessions will be delivered by peers on an individual basis~     at a location of convenience to the TPs (usually at their own homes).~      Implications THPP-I has the potential to advance knowledge of the extent to which~     task-shifting of the delivery of evidence-based psychological treatments can be extended to~     peers in the community. If effectiveness is observed, this approach offers a potential~     opportunity to access a vast untapped human resource for maternal mental health care and~     addresses a major barrier in global mental health - the lack of skilled and motivated human~     resources in the formal health sector - offering a new avenue for the scaling up of~     evidence-based psychological treatments and mental health services in low resourced settings.~   "
111788|NCT02104219|"~     The purpose of this study is to characterize the natural history of HPP in patients with~     Juvenile-onset HPP.~   "
111789|NCT02104193|"~     The purpose of the study is to evaluate the effect of simvastatin in combination with~     radiotherapy on the clinical outcomes of patients with brain metastases.~   "
111790|NCT02104180|"~     Evaluation of the non-inferiority of TulleGras M.S.® versus Urgotul® in pain associated with~     removal of wound dressing during care of venous leg ulcer~   "
111791|NCT02104167|"~     The purpose of this combined retrospective and prospective clinical study is to examine~     safety and efficacy of the ROI-C® anterior cervical interbody fusion device with VerteBRIDGE®~     plating to treat single level degenerative disc disease between C2 and T1 in the short term,~     with a focus on fusion rates.~   "
111792|NCT02104154|"~     To establish the performance characteristics of the Samsung LABGEO PT10 by comparing the test~     results of the PT10 Hepatic assay with results obtained from an FDA-cleared chemistry~     analyzer.~   "
111794|NCT02104128|"~     This study will investigate the role of dopaminergic neural systems in the symptoms and~     treatment of depression. 40 patients who meet DSM-IV criteria for a diagnosis of depression~     will be compared to a matched sample of healthy controls. The depressed group will receive~     open label treatment with Bupropion MR (150mg bd) for 6 weeks. The control group will receive~     no treatment. All participants will be assessed before treatment, after 2 weeks treatment and~     at 6 weeks treatment. The outcomes assessed will be 1) fMRI estimates of neural response to~     reward to emotionally valenced stimuli (1st and 2nd assessments), 2) computer based measures~     of emotional processing (all assessments) and 3) standardised questionnaire measures of~     depressive symptoms (all assessments). The primary study hypothesis is that altering central~     dopamine using Bupropion will lead to altered neural responses to rewarding stimuli in the~     depressed patients (i.e. comparing fMRI outcomes between assessment visits 1 and 2). A~     secondary hypothesis is that this neural change will predict subsequent symptom response to~     the bupropion (i.e. comparing symptom scores between assessment visits 1 and 3), Lastly, the~     study will test the hypothesis that baseline differences in reward circuitry will be~     particularly associated with symptoms of anhedonia (the inability to experience pleasure).~   "
111795|NCT02104115|"~     The investigators will apply non invasive Magnetic Resonance Imaging (MRI) techniques~     developed in Nottingham to evaluate the gastric emptying, small bowel water content, colonic~     gas and volumes in healthy volunteers eating three breads with different amount of gluten~     (none, normal, or high gluten) in three consecutive weeks.~   "
111796|NCT02104102|"~     Check if the Mirror therapy represents an effective method in improving the motor activity of~     the hands of institutionalized elderly.~   "
111797|NCT02104089|"~     The Zenith® t-Branch™ Thoracoabdominal Endovascular Graft Study is a post-market~     observational study to evaluate the performance of the Zenith® t-Branch™ in the treatment of~     thoracoabdominal aortic aneurysms in routine care.~   "
111798|NCT02104076|"~     The Evolution® Biliary Stent System-Fully Covered study is a clinical trial approved by the~     US FDA to evaluate the effectiveness of the Evolution® Biliary Stent System-Fully Covered~     when used in palliation of malignant neoplasms in the biliary tree.~   "
111799|NCT02104063|"~     The presence of metastatic disease in the lymph nodes within the groin is the most important~     factor in predicting the long-term outcome for patients diagnosed with penile cancer.~      In the majority of patients diagnosed with penile cancer obvious abnormalities cannot be felt~     in the groin even though the cancer may have already spread to the lymph nodes in the groin.~     In these patients, a procedure called Dynamic Sentinel Lymph Node Biopsy (DSLB) is required~     to determine if the cancer has spread to the lymph nodes in the groin. In DSLB a radioactive~     substance is injected at the site of the penile cancer and then travels to the lymph nodes in~     the groin which are then biopsied. This procedure requires a general anaesthetic and an~     in-patient hospital stay.~      In approximately 20% of patients with penile cancer obvious abnormalities can be felt in the~     lymph nodes in the groin. However, any abnormality detected may not necessarily be due to~     metastatic disease. In order to confirm if metastatic disease is present in the lymph nodes~     of these patients a biopsy is also required. However in these patients the lymph nodes are~     detected and biopsied using an ultrasound scan rather than by passing a radioactive substance~     into the body.~      MRI-PET is a new procedure which combines conventional MRI (Magnetic Resonance Imaging) and~     PET (Positron Emission Tomography) scans into one scan. MRI - PET scans create very clear~     pictures of internal body structures. MRI-PET is a non-invasive procedure which can be~     performed on an out-patient basis.~      The accuracy of MRI-PET in detecting metastatic penile cancer is not known. The main purpose~     of this study is to establish the effectiveness of MRI-PET compared to DSLB and ultrasound~     guided biopsy in detecting the presence of metastatic disease in the lymph nodes of patients~     with penile cancer. If effective, MRI-PET could replace the invasive procedures currently~     required for detection of metastatic penile cancer.~   "
111800|NCT02104050|"~     The objectives of this trial are to investigate the efficacy and safety of six weeks of~     treatment with OLT1177 Gel in subjects with moderate to severe pain associated with~     osteoarthritis of the knee following cessation of pain therapy.~   "
111801|NCT02104037|"~     The purpose of this study is to investigate transfer of liraglutide from blood to~     cerebrospinal fluid.~   "
111802|NCT02104024|"~     This study is to investigate whether it is possible to use a special type of ultrasound scan~     (CEUS, Contrast Enhanced Ultrasound Scan) to view the shape, assess blood supply and~     calculate the amount of oxygen being carried to a transplanted kidney and pancreas. We~     currently use a nuclear scan (Transcan) to assess this in the kidney. This is cumbersome,~     involves nuclear medicine and takes 45- 60 minutes to complete.~      We do not routinely image the blood supply to the pancreas post-surgery, despite the most~     common complication post pancreas transplantation being vascular in origin. In an emergency a~     CT angiogram is carried out. This involves transfer of a sick patient to the CT scanner and~     injection of contrast which is harmful to the kidneys.~      CEUS involves injection of a safe contrast prior to conducting an ultrasound scan. This can~     be carried out at the bed-side, provides instant results and is cheap and safe enough to do~     on a routine basis for all kidney and pancreas transplant recipients. Although the uses of~     CEUS are well recognised, it is currently not routinely used in transplantation. CEUS has~     been compared to other modes of imaging and has been found to be comparable/ beneficial.~     However, it has never been compared to Transcan. We will therefore perform CEUS on our kidney~     transplant recipients and compare the results to Transcan. We will also assess whether CEUS~     is able to visualise the blood supply to the kidney and pancreas and quantify the perfusion~     to the pancreas.~   "
111803|NCT02104011|"~     Treatment of angiomyolipomas is based on invasive techniques such as surgery or embolization.~     Development of anti-angiogenic therapies is a major and growing field of research in~     hypervascularized tumors. Angiomyolipomas have been shown to regress after prolonged~     treatment with mTOR inhibitors (Sirolimus), but with a large proportion of secondary effects.~     We showed recently that beta-blockers were able to induce regression of infantile hemagiomas.~     Consequently, we looked for and found, histologically, in a few cases of angiomyolipomas the~     presence of beta2 receptors.~      The aim of the study is to estimate if beta-blockers could induce regression or stabilization~     of renal angiomyolipomas in tuberous sclerosis in a pilot study.~   "
111804|NCT02103998|"~     The investigators hypothesize that continuous infusion of 4 µg/Kg/day T4 with 30 µg/Kg/day~     oral potassium iodide (KI) for 42 days from birth will reduce by 30% or more (from an~     estimated 30% to 21%) the proportion of extremely low gestational age subjects with a~     composite endpoint of cerebral palsy (CP) or a Bayley III Composite Cognitive Score < 85 at~     36 months corrected postnatal age (CA).~   "
111805|NCT02103985|"~     The purpose of this study is to evaluate the effect of food on the bioavailability of a~     single oral dose of JNJ-39823277 and its active metabolites.~   "
111806|NCT02103972|"~     The primary objective of this trial is to assess the efficacy of the consumption of~     heat-treated Lactobacillus paracasei (GM080) on atopic dermatitis as compared to a placebo~     treatment.~   "
111807|NCT02103959|"~     The objective of this study is to evaluate CMX-2043 for prevention of renal and cardiac~     injury associated with coronary angiography in patients with acute coronary syndrome (ACS),~     but excluding ST-elevation myocardial infarction (STEMI) patients. This study will~     specifically examine the ability of CMX-2043 to prevent acute renal injury following coronary~     angiography. The study will also examine the ability of CMX 2043 for prevention of~     periprocedural cardiac injury. Information will be obtained relating to the ability of CMX~     2043 for prevention of major adverse cardiac and renal events following the procedure.~     Additional information will be obtained in this study to evaluate safety of the drug. Dose~     and regimen information will also be obtained for future clinical studies of CMX-2043.~   "
111808|NCT02103946|"~     ًًًُُُُThe investigators are testing the efficacy of a new novel technique; serratus anterior~     plane block, for preventing postoperative pain after breast surgery for cancer. This block~     will be compared with the well-established paravertebral block.~   "
111809|NCT02103933|"~     The purpose of this study is to assess the level of knowledge of surgery for women who~     underwent hysterectomy~   "
111810|NCT02103920|"~     The purpose of this study is to determine the expression of molecules involved in the~     glycine/serine pathway using immunohistochemistry in solid tumors. Archived paraffin-embedded~     pathological specimens from the Department of Pathology, NUH will be obtained. Tissue~     microarray (TMA) is a high-throughput method of analysing large numbers of formalin-fixed,~     paraffin-embedded tumor at a minimal cost and effort. To analyse the expression of molecules~     of putative relevance to the glycine/serine pathway, (such as PSPH, PSAT1, SHMT1, and GLDC),~     TMA technology will be utilised as previously reported (Kristiansen, Zhang, Soong). Tissue~     arrays will be constructed from solid tumors including cancers of the colon/ rectum, lung,~     breast, cervix, ovary, endometrium, fallopian tube, prostate, kidney, testis, stomach, liver,~     brain and lymphoma. One hundred cases of each tumor type (subject to availability) will be~     stained using immunohistochemistry. Patient Identifiers will not be collected. Societal~     benefit in terms of knowledge gained to improve understanding of cancer. No direct risk to~     subjects as this is a retrospective study of archived pathological tumour samples.~   "
111811|NCT02103907|"~     There is a high prevalence of falls in those with knee osteoarthritis (OA) compared to~     healthy older adults. Balance is a key element of function that allows individuals to~     maintain posture and respond to perturbations, and poor balance control, a risk factor for~     falls, has been noted in those with knee OA. There is a lack of research guiding treatment~     for balance deficits in knee OA, with interventions aimed at improving balance deficits in~     those with knee OA having mixed results. Targeted dynamic balance interventions in other~     patient populations have been shown to significantly improve dynamic balance control and~     physical function. If results similar to such populations can be achieved, such a program may~     produce a significant reduction in functional disability in the knee OA population and~     improve quality of life. The purpose of this study is to examine the effect of a 10-week~     targeted dynamic balance intervention on dynamic balance and physical function in people with~     knee OA. This will be a randomized controlled trial (RCT).~   "
111812|NCT02103894|"~     The goal of this study is to assess [18F]MNI-777 PET imaging as a tool to detect tau~     pathology in the brain of individuals who carry a clinical diagnosis of a tauopathy,~     including: Alzheimer's Disease (AD),Parkinson's disease (PD) Progressive Supranuclear Palsy~     (PSP), chronic traumatic encephalopathy (CTE) and Frontal Temporal Dementia (FTD) and age-~     and gender-matched healthy subjects.~   "
111813|NCT02103881|"~     This research study is being done to find out if one of two drugs, ketamine or haloperidol,~     is better for treating agitation. Agitation is a state of extreme emotional disturbance where~     patients can become physically aggressive or violent, endangering themselves and those who~     are caring for them. Often chemical substances or severe mental illness is involved in this~     level of agitation. Specifically, the investigators are interested in studying agitation that~     is treated in the prehospital setting by paramedics. This study's hypothesis is that ketamine~     is superior to haloperidol for treatment of agitation in the prehospital environment.~   "
111814|NCT02103868|"~     Zari workers in Mumbai city will be assessed for tobacco consumption habit. They will be~     divided into 3 arms as - 1) First arm will get Medium intensity tobacco cessation~     intervention 2) Second arm will get low intensity tobacco cessation intervention 3) Control~     arm. At the end of 12 months of intervention quit rates will be compared.~   "
111815|NCT02103855|"~     Kidney damage is a major complication of current antirejection medicines used in~     transplantation. An increasing number of brittle diabetics are successfully receiving a~     pancreas transplant. One of the challenges following pancreas transplant is that a patient~     can develop kidney damage from one of their antirejection medicines, tacrolimus. The~     objective of this study is to substitute a new antirejection medicine which does not cause~     kidney damage, belatacept for tacrolimus in patients that have developed signs of tacrolimus~     related kidney damage to slow the progression of kidney disease.~   "
111816|NCT02103842|"~     The purpose of this study is to determine how omega-3 fatty acids influence muscle protein~     metabolism and mitochondrial physiology in the context of human aging.~   "
111817|NCT02103829|"~     Most individuals who smoke want to quit smoking. Most individuals who want to quit, quit on~     their own. The purpose of this study is to determine whether very brief suggestions provided~     online are comparatively more effective than others in increasing motivation to quit~     immediately after the suggestions are implemented and actual quit rates one month later.~      There are no costs associated with participating in this study and participants will not be~     compensated for their participation.~      To join the study paste the following link into your browser:~      https://www.i4health-pau.org/quit-smoking-on-your-own~      The entire study takes place online on an automated website.~   "
111818|NCT02103816|"~     The purpose of this study to evaluate the SmartLipo Triplex laser system along with the~     SideLaze800 hand piece in the treatment of Acne Scars.~   "
111819|NCT02103803|"~     This proposal aims to describe the oculometric features present during King-Devick (K-D)~     testing for subjects who experienced sports-related concussion. The investigators aim to~     better describe the underlying oculomotor anomalies present in this cohort that lead to~     increased K-D test time. Understanding these anomalies will allow for better understanding of~     the effects of sports-related concussion and may provide a rapid and reliable metric for~     diagnosing concussion as well as monitoring long-term recovery.~   "
111820|NCT02103790|"~     Neuromuscular diseases are frequently associated with respiratory failure, which requires Non~     Invasive Ventilation (NIV). Currently, the NIV installation is done during an hospitalization~     of several days. This hospitalization is problematic because of availability of beds,~     logistical difficulties for the patient and estrangement from the usual environment.~      For this reasons, the NIV installation at home could be an interesting alternative for both~     the patient and the medical staff.~      The aim of this pilot study is to test the feasibility of NIV installation at home, using~     telemedicine as a remote monitoring tool, and to assess its impact on the ventilation~     compliance.~   "
111821|NCT02103777|"~     The optimum caffeine dose for apnea of prematurity has not been well investigated so the~     objective of the study is to compare high versus low dose of caffeine citrate to facilitate~     successful extubation in mechanically ventilated preterm infants.~   "
111822|NCT02103764|"~     The objectives of the present study is to determine the effectiveness of cyclic desogestrel~     (DSG) compared with cyclic medroxyprogesterone acetate for the treatment of anovulatory~     dysfunctional uterine bleeding (DUB) in the following aspects:~        1. Endometrial histopathology changes~        2. Menstrual cycle control.~   "
111823|NCT02103751|"~     The purpose of this study is to determine biomarkers of exposure to Harmful and Potentially~     Harmful Constituents (HPHCs) in Cigarette Smoke and cardiovascular-related biomarkers in~     smokers and non smokers.~   "
111824|NCT02103738|"~     This is an observational study to will evaluate and compare two Ranibizumab treatment~     regimens (Standard of care) in patients with neovascular (wet) age-related macular~     degeneration (wAMD) aiming to achieve and to maintain a maximum visual function benefit. The~     results will be used to generate further recommendations on the timing of treatment~     administration for patients with neovascular (wet) age-related macular degeneration (wAMD).~     In this context, the study will use the anatomical imaging (for example, optical coherence~     tomography [OCT]) to evaluate wAMD disease activity impacted by the recurrence of disease~     instability and for decision making in the treatment decision algorithm.~   "
111825|NCT02103725|"~     The purpose of this study is to validate a left-right design with respect to detecting a~     difference in efficacy after 3 weeks of treatment between an active treatment and a vehicle~     in adults with mild to moderate atopic dermatitis~   "
111826|NCT02103712|"~     Hypospadias is a common congenital abnormality of the penis which affects approximately 1 boy~     in 250. The opening of the urethra is located on the undersurface of the penis rather than~     the tip,the foreskin is deficient and there is curvature of the penile shaft in more severe~     cases. Although the most commonly practised corrective operation ( TIP procedure) gives~     generally good results, recently published evidence points to a possible long term risk of~     stenosis ( narrowing of the reconstructed urethra). This comparative study will combine~     clinical assessment with non invasive measurements of urinary flow to assess the functional~     outcome of a large series of patients who have undergone hypospadias surgery . The study is~     primarily designed to answer this question : does a modification of the standard operation~     which incorporates a skin graft into the reconstructed urethra lead to improved urinary flow~     and a decreased risk of stenosis? This has not been previously studied . The findings of our~     study could make an important contribution to improvements in the surgical treatment of boys~     born with hypospadias.~   "
111827|NCT02103699|"~     The purpose of this study is to evaluate the effectiveness of a simeprevir-containing~     hepatitis C virus (HCV) treatment regimen as measured by sustained virologic response (SVR).~   "
111828|NCT02103686|"~     The purpose of this study is to:~        1. Compare the pharmacokinetics profiles of pregabalin sustained release tablet (300mg) to~          immediate release capsule(150mg * 2).~        2. Evaluate the effectiveness of food to pharmacokinetics profile of Pregabalin sustained~          release tablet.~   "
111829|NCT02103673|"~     The population of dementia is increasing rapidly. Cognitive impairment as well as Behavioral~     and psychological symptoms of dementia (BPSD) add heavy burdens to caregiver. NMDA activation~     is critical for learning and memory. Individuals with Alzheimer's disease (AD) have fewer~     NMDA receptors in the frontal cortex and hippocampus than controls. This study is a~     randomized, double-blind, placebo-controlled drug trial. All patients will be allocated~     randomly to two groups: (1) NMDA enhancer: DAOIB (starting dosage: 250-500 mg/day), (2)~     placebo, for 6 weeks. The investigators hypothesize that DAOIB may yield better efficacy than~     placebo for cognitive function and clinical symptoms in patients with BPSD.~   "
111830|NCT02103660|"~     The purpose of this study is to determine the acceptability of randomization to contraceptive~     options and estimate the effect of progestin contraception on HIV genital shedding and~     inflammatory/immune perturbations in women who may or may not be on antiretroviral therapy,~     as well as in HIV-uninfected women controls. It is hypothesized that progestin-containing~     contraception will lead to inflammatory changes that may affect the local immune activity,~     influencing HIV acquisition or transmissibility risk.~   "
111831|NCT02103647|"~     The purpose of this study is to compare the pharmacokinetics profiles of pregabalin sustained~     release tablet (300mg) to immediate release capsule(150mg * 2) while multiple dosing.~   "
111832|NCT02103634|"~     This study will look at two new technologies being developed for measuring cancer in bones.~     One of these technologies is a substance called Sodium Fluoride (NaF). Fluoride is a normal~     body substance. The amount that patients will receive has been shown to be very safe. One~     study of over 400 patients showed no adverse reactions after receiving the recommended~     dosage.~      NaF (known as a radiotracer) is taken up into the bones under a normal process and~     researchers can measure the amount within patient's bones through an imaging system called a~     Positron Emission Tomography/Magnetic Resonance Imaging (PET/MRI). This system combines~     aspects of both a PET study as part of the regular standard of care and an MRI study. The~     belief is that the combination of these two studies will be better than either study~     alone.People who have enrolled in this study will receive their clinically requested PET/CT~     scan as part of their normal diagnostic care and will follow all the said recommendations for~     this study such as not being pregnant, having fasted overnight, etc. Subjects will return~     within 7 days for a 10 mCi NaF PET/MRI study. The patients' imaging time will be up to 120~     minutes depending on the MRI sequences acquired. Imaging for the PET portion of the study~     will take approximately 20-30 minutes with the rest of the time devoted to MRI sequences.~   "
111839|NCT02103543|"~     Patients with back pain with spinal stenosis of the lower back will be asked to volunteer for~     this research study. These patients don't need immediate surgery for this problem. Treatment~     of this kind of back pain with spinal stenosis usually includes physical therapy exercises~     and steroid injections. Both treatments are usually helpful in patients with back pain with~     spinal stenosis. However, physicians and other healthcare providers don't know which~     treatment is better to give first. The purpose of this research is to answer that question.~     Patients enrolled in this study will receive both treatments: physical therapy (PT) and a~     steroid injection (shot). However, patients may get the shot first followed by PT, or they~     may have PT first, followed by the shot. Their time in this study will last up to 6 months,~     and there will be five outcome measurements (via visits or telephone). All study visits will~     take place at the Atlanta VA Medical Center (Atlanta VA). Investigators hope to enroll about~     120 subjects from the Atlanta VA. Enrolled patients will be randomized using a randomization~     computer program.~   "
111840|NCT02103530|"~     The purpose of this study is to investigate whether F-18 FLT PET/CT is useful in early~     response assessment of induction chemotherapy in acute myeloid leukemia patients.~   "
111841|NCT02103517|"~     The purpose of this study is to determine whether omega-3 fatty acids supplementation are~     effective in the improvement of suboptimal health status and cardiovascular risk.~   "
111842|NCT02103504|"~     The DePuy Attune knee system incorporates several key features aimed at improving kinematics~     of the knee joint, range of motion, and smoothness of use compared to existing total knee~     replacement technologies. As this is a newly approved medical device, clinical testing in~     patients using high precision diagnostics is important to evaluate the stability of implant~     fixation and in vivo function. We propose a multi-centre consecutive series study examining~     the stability of the Attune posterior-stabilized knee design in 30 patients undergoing total~     knee arthroplasty for a follow-up period of 2 years. Radiostereometric analysis (RSA) will be~     utilized to identify the micromotion of the tibial tray with respect to the surrounding bone.~     Health status and functional outcome measures will be recorded to quantify functional status~     of subjects before surgery and at follow-up intervals.~   "
111843|NCT02103491|"~     Background: Ultradistance athletes frequently consume salt supplements during competitions to~     compensate the loss of electrolytes by sweating. The aim of this study was to investigate the~     effectiveness of oral salt supplementation to improve exercise performance during a~     half-ironman triathlon. Methodology: Twenty-six experienced triathletes were matched for age,~     anthropometric data and training status and randomly placed into the salt group (113 mmol Na+~     and 112 mmol Cl-) or the control group (cellulose). The experimental treatments were provided~     in unidentifiable capsules and were ingested before and during the race. Participants~     competed in a real half-ironman triathlon and race time was measured by means of chip timing.~     Pre and post-race, body mass, maximal force during a whole-body isometric strength test,~     maximal height during a countermovement jump, and blood samples were obtained. Sweat samples~     were obtained during the running section.~   "
111844|NCT02103478|"~     This 2-stage, open-label study will evaluate safety and pharmacokinetics of ASTX727, as well~     as determine the dose for the study's second stage. In the second stage the selected dose~     will be confirmed and evaluated for clinical activity, including response rate.~   "
111845|NCT02103465|"~     This exploratory trial will fulfill a medical data gap for the dopamine-agonist rotigotine,~     as so far no data on elderly population is available.~      Primary objective: To assess efficacy and safety of rotigotine in patients with late onset~     Parkinson's Disease (PD), starting at age 70 or later, on motor symptoms.~      Secondary objective: To assess efficacy and safety of rotigotine in patients with late onset~     Parkinson's Disease (PD), starting at age 70 or later, on selected non motor symptoms : sleep~     quality; depression; cognitive function.~      Subjects ≥70 years, with diagnosis of Parkinson's Disease (PD) based on the presence of at~     least two of three cardinal features (bradykinesia, resting tremor, rigidity), within 12~     months since diagnosis and no longer than 12 months from onset to diagnosis, and for whom the~     caring physician is uncertain on whether or not to start treatment.~      Outcome Measurement: Percentage of Responders to treatment in motor (part III) and Activities~     of daily living (ADL) (part II) components of Unified Parkinson's Disease Rating Scale~     (UPDRS) at visit 4 and 6; Percentage of Responders to treatment in sleep quality in relation~     to Parkinson's Disease Sleep Scale (PDSS)-2 at visit 4 and 6; Responders to treatment in mood~     in relation to Geriatric Depression Scale (GDS) at visit 4 and 6.~      Exploratory, randomized, double blind, placebo-controlled study: 80 patients with late onset~     Parkinson's Disease (PD) are randomized in 2 parallel groups, ratio 1:1.~      One group will be treated with rotigotine and one group will be treated with placebo, for 12~     weeks after titration.~   "
111846|NCT02103452|"~     Purpose of this study is to evaluate stem cell expression (SCE) in endometriotic (E) and non~     endometriotic ovarian and endometrial tissues.~   "
111847|NCT02103439|"~     The purpose of the study is to demonstrate the noninferiority of Algeron in combination with~     ribavirin compared to PegIntron in combination with ribavirin in treatment of chronic~     hepatitis C in Human Immunodeficiency Virus-1 infected patients~   "
111848|NCT02103426|"~     The purpose of the study is to determine whether ASP0113 (a CMV deoxyribonucleic acid [DNA]~     vaccine) can be detected in plasma after intramuscular (IM) injections, and to determine~     whether CMV-seropositive healthy volunteers, CMV-seronegative healthy volunteers,~     CMV-seronegative dialysis patients mount an immune response to the CMV proteins produced by~     the vaccine after repeated ASP0113 IM injection.~   "
111860|NCT02103270|"~     Determine whether peanut oral immunotherapy (OIT) induces clinical tolerance as assessed~     after the initial 3 month avoidance period~      Secondary Objectives:~        -  Identify the basic immune mechanisms which can explain the differences in the effects of~          OIT in desensitized vs. tolerant individuals.~        -  Determine whether immune monitoring measurements reflecting underlying mechanisms during~          OIT can be used to predict responses to OIT in individual subjects and, ultimately, to~          improve the safety and efficacy outcomes in peanut OIT protocols.~   "
111861|NCT02103257|"~     This randomised, controlled, multicentre trial is designed to assess the efficacy and safety~     of sequential icotinib plus chemotherapy versus single icotinib as first-line treatment in~     stage IIIB/IV lung adenocarcinoma patients with EGFR mutation.~   "
111849|NCT02103413|"~     Although ERCP is almost always successful in patients with malignant biliary obstruction,~     selective biliary cannulation fails in some cases and conventional ERCP may not be possible~     in patients with tumor invasion of the duodenum or major papilla, surgically altered anatomy~     (e.g., Roux-en-Y anastomosis), or complex hilar biliary strictures. In such cases,~     percutaneous transhepatic biliary drainage (PTBD) is an useful alternative. However, PTBD had~     various complications and the presence of an external drainage catheter would also have a~     cosmetic problem related to the external drainage and an adverse impact on quality of life~     (QOL) of terminally ill patients.~      Since endoscopic ultrasound-guided bile duct puncture was described in 1996, sporadic case~     reports of EUS-guided biliary drainage (EUS-BD) suggested that it was a feasible and~     effective alternative in patients with failed conventional ERCP stenting. The potential~     benefits of EUS-BD include one-stage procedure in ERCP unit, and internal drainage for~     avoiding long-term external drainage in cases where external PTBD drainage catheters cannot~     be internalized, thus significantly improving the QOL of terminally ill patients, and~     possibly lower morbidity than PTBD or surgery.~      Up to date, only a few case series of EUS-BD with small numbers of patients have been~     published, and known the feasibility and safety in terms of the incidence of~     procedure-related clinical outcomes.10-21 There has been no comparative study between the~     outcomes of PTBD and EUS-BD focusing on the QOL, cost-effectiveness, and complications.~      The researchers investigated the technical success of EUS-BD and PTBD in patients with~     malignant biliary obstruction after failed conventional ERCP as a prospective randomized~     comparative study in multicenters. Secondary endpoints were the cost-effectiveness and~     complications rates between EUS-BD and PTBD.~   "
111850|NCT02103400|"~     Hospitalized patients with community-acquired pneumonia (CAP) have reduced functional~     capacity, peripheral muscle strength and quality of life. Despite the high incidence and~     severity has not yet been demonstrated whether a physical training program can change these~     outcomes. Objectives: To evaluate the effects of an exercise training program in patients~     hospitalized for CAP, to compare this effects with traditional physical therapy and assess~     whether the inflammatory markers correlate with the functional status of the patient and type~     of treatment. Methods: A controlled, prospective, randomized clinical trial. Patients~     hospitalized for CAP, adults, conscious, hemodynamically stable and independent to walk will~     be studied. In the first day, a medical history, measured dyspnea, incremental shuttle walk~     test, Glittre test, measurement of peripheral muscle strength, spirometry, and the~     application of quality of life questionnaire Shor Form 36 will be held. The measurement of~     inflammatory markers (C-reactive protein and tumor necrosis factor) will also be held.~     Patients will be randomized into two groups: one will perform a program of physical training~     (stretching, active resistance exercises and aerobic exercises) and the other group held the~     traditional physical therapy (bronchial hygiene, breathing exercises and walking) for eight~     days. On the tenth day the same assessment will be carried out initially described.~   "
111851|NCT02103387|"~     To test the effects of 2 different 5-wk stress management interventions (cognitive behavioral~     training or relaxation training) vs. a time-matched 5-wk health education condition on~     psychosocial adaptation and physiological adaptation in women being treated for breast~     cancer. Participants assigned to either of the stress management conditions will show~     improved psychosocial adaptation and physiological adaptation compared to those assigned to~     the health education condition.~   "
111852|NCT02103374|"~     Design studies of nebulization in COPD does not respond adequately to the clinically relevant~     question: the intervention of administering nebulized bronchodilators at home it is likely to~     make a profit, compared to the standard optimized treatment as defined by the recommendations~     of the SPLF, patients with severe COPD (stage III, FEV between 30% and 50% of the theoretical~     value) and very severe (stage IV, less than 30% of the theoretical value FEV)? The concept of~     profit in this context is based on criteria of dyspnea, quality of life, use of health system~     (exacerbations, hospitalizations, prescription of antibiotics and steroids ...).~   "
111853|NCT02103361|"~     The purpose of the OTIS Autoimmune Diseases in Pregnancy Study is to monitor planned and~     unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic~     effect of these medications and to follow live born infants for one year after birth. With~     respect to fetal outcome, it is important to evaluate the spectrum of outcomes that may be~     relevant to a medication exposure during pregnancy, and these include both easily~     recognizable defects which are visible at birth, as well as more subtle or delayed defects~     that may not be readily identifiable without special expertise and observation beyond the~     newborn period.~   "
111854|NCT02103348|"~     This study is designed to characterize subjects in terms of their sputum phenotype. The~     purpose of this study is to learn more about the impact of having abnormally elastic sputum~     on asthma severity by comparing subjects with severe as well as mild/moderate asthma to~     healthy controls. The characterization will include medical history, pulmonary function~     testing, imaging of the lungs and biospecimen collection.~   "
111855|NCT02103335|"~     This is a Phase 1 clinical trial to evaluate a new combination of drugs for the treatment of~     relapsed or refractory (drug-resistant) multiple myeloma. The drugs being studied are:~        -  Pomalidomide (POMALYST®) is a drug that affects the immune system (an immunomodulatory~          drug) that has been approved by the United States (US) Food and Drug Administration~          (FDA) for the treatment of multiple myeloma.~        -  Marizomib is an investigational drug being developed by Triphase that is being studied~          for the treatment of multiple myeloma. Investigational drugs are drugs that have not yet~          been approved by health authorities, such as the FDA, for general use but have been~          approved for use in specific clinical studies. Marizomib inhibits a cellular machine~          called the proteasome, which destroys unnecessary or damaged proteins. Other proteasome~          inhibitors have been shown to be effective in the treatment of multiple myeloma.~        -  Dexamethasone is a corticosteroid drug that affects the immune system (an~          immunomodulatory drug) that has been approved by the FDA for the treatment of multiple~          myeloma.~      This is the first study to evaluate the three-drug combination of pomalidomide (POM),~     marizomib (MRZ), and dexamethasone (LD-DEX) in humans. Pomalidomide, alone or in combination~     with dexamethasone, is approved by the FDA for the treatment of relapsed or refractory~     multiple myeloma.~      The primary objective of this study is to determine the best drug dosing levels for this~     three-drug combination, including the highest safe doses and/or the recommended doses for~     future clinical studies of this drug combination. The secondary purposes of this study are to~     determine the safety of this drug combination and its effectiveness in treating relapsed or~     refractory multiple myeloma. The study will include examination of levels of all three drugs~     in the blood during various time points during treatment.~   "
111856|NCT02103322|"~     To characterize pharmacokinetic profile of test product compared to that of the corresponding~     reference product in adult patients, who are diagnosed to have Chronic Myeloid Leukemia &~     Gastrointestinal Stromal Tumor under Fed Conditions.~   "
111857|NCT02103309|"~     The purpose of this study is to evaluate lens centration and subjective impressions of~     DAILIES® AquaComfort Plus® (DACP) lenses compared to 1-DAY ACUVUE® MOIST® (1DAM) lenses in~     ball sports players.~   "
111858|NCT02103296|"~     The goal of this protocol is to establish a randomized clinical trial comparing the use of~     cord blood vs. infant blood with the primary outcome of comparing both the absolute~     hemoglobin concentration and the percent change in hemoglobin concentration from baseline~     around 24 hours of life.~   "
111859|NCT02103283|"~     A Phase 1 Study to evaluate the Safety of teprotumumab in Patients with Diabetic Macular~     Edema.~   "
114585|NCT02067637|"~     Hypotheses and Specific Aims: There is limited data on the long-term consequences of cancer~     therapy on young, reproductively aged cancer survivors. The investigators objective is to~     characterize some of these effects in the cancer population.~   "
111864|NCT02103218|"~     African American adolescent females are more likely to have sex at an early age, to have~     older sex partners that have had multiple sexual experiences, and are less likely to use a~     condom than their white counterparts. Lack of sexual assertiveness is a factor in the risky~     sex behaviors of young African American women. African American girls at the greatest risk~     for contracting HIV are the ones that report that their partners could convince them to have~     sex and report trouble communicating their wishes related to sex. Thus far no intervention~     has addressed the disparate rate of HIV infection in young African American girls. This study~     is unique in promoting increases in racial pride as a component of empowerment to help~     African American girls self-protect against HIV. The study has the potential to empower young~     African American girls to delay sex initiation or reduce risky sex behaviors and thus reduce~     their risk of contracting HIV.~   "
111865|NCT02103205|"~     Breast milk is the gold standard of early infant nutrition and breastfed infants have~     advantages in several short and long term outcomes compared to those formula-fed.~      The first aim of this study is to evaluate the effect of adding bovine lactoferrin to infant~     formula. The general hypothesis is that bovine lactoferrin reduces some of the previously~     observed differences between formula-fed and breast-fed infants with regard to health and~     development. The main outcome studied is the effect on immune function. The second aim is to~     study the effects of lower iron concentration in infant formula and to test the hypothesis~     that iron can be lowered without negative effects on health and development. The main outcome~     studied here is iron status. Other outcomes in this trial are microbiota composition,~     metabolomics, growth, body composition and cognitive development.~      To test the lactoferrin hypothesis, formula-fed infants will be recruited and fed a low iron~     (2 mg/L) control formula, or the same formula supplemented with bovine lactoferrin. To test~     the iron hypothesis, a third group will be fed the same formula (no lactoferrin) with higher~     iron concentration (8 mg/L). Group allocation for all formula-fed infants will be~     double-blind randomized. Additionally, breast-fed infants will be recruited and used as a~     reference group (gold standard).~   "
111866|NCT02103192|"~     The objective of this study is to assess the effects of nutrient-fortified beverage on mental~     energy in healthy human subjects.~   "
111867|NCT02103179|"~     The investigators study the VEGF signaling in ECC cell lines,patients and its mechanism in~     ECC growth, proliferation and apoptosis.~   "
111868|NCT02103166|"~     The purpose of this study is to determine whether hyoscine bromide decreases the duration of~     the active phase of labor.~   "
111869|NCT02103153|"~     The purpose of this study is to evaluate the PICOSURE Laser System for the treatment of~     unwanted tattoos~   "
111870|NCT02103140|"~     Among African-American women, in whom metabolic syndrome (MetS) is very prevalent and breast~     cancer mortality rates are high, it is hypothesized that intervening on MetS to improve the~     MetS profile may prove to be a means to reduce breast cancer risk. Specific recommendations~     for breast cancer prevention are now focused on maintaining a healthy weight via increased~     physical activity levels, and losing weight if overweight or obese.~      This pilot project compares two exercise interventions: a supervised facility-based and a~     home-based exercise intervention to a control group in African-American women with metabolic~     syndrome who are at high risk for breast cancer. This study is a 6-month three-arm RCT to~     assess the impact of the exercise interventions on biomarkers related to obesity,~     insulin-related pathways, inflammation, hormones, and micro-RNAs.~      The specific aim of the proposed study is to compare the impact of a supervised~     facility-based and a home-based exercise intervention on obesity, metabolic syndrome and~     known breast cancer biomarkers in postmenopausal African-American women with metabolic~     syndrome who are at increased risk of breast cancer.~   "
111871|NCT02103127|"~     The purpose of this study is to assess treatment of facial acne scars using the 755nm~     Alexandrite Laser with lens arrays.~   "
111872|NCT02103114|"~     The purpose of this study is to test whether the administration of ATIII during the~     intra-operative period results in improved anticoagulation for cardiopulmonary bypass (CPB)~     and an attenuation of the activation of the coagulation cascade, as represented by a decrease~     in fibrin degradation products. The investigators believe this benefit would extend into the~     post-operative period resulting in a decreased incidence of thrombosis generation, as~     represented by a decrease in fibrin degradation products in the ICU period.~   "
111873|NCT02103101|"~     Vitamin K antagonists were hampered by several disadvantages, such as the need for frequent~     monitoring. In this context, new oral anticoagulants (NOACs) have been developed and are now~     available on the market. These NOACs, like all anticoagulant drugs, continue to be associated~     with an increased risk of bleeding. In addition, the lack of antidote and the absence of~     valid data regarding biological monitoring can pose problems in case of overdose or when~     emergency surgery is required. Studies investigating the pharmacokinetic properties of~     rivaroxaban and dabigatran, two NOACs now approved for the market, have shown high~     variability between individuals, with coefficients of variation of up to 60% for some~     pharmacokinetic parameters in patients treated after orthopaedic surgery. The relation~     between plasma concentrations of NOAC and bleeding risk has been clearly established in~     clinical trials.~      Dabigtran, rivaroxaban and apixaban are known substrates of P-glycoprotein (Pgp). Pgp~     activity can be affected by pharmacological inducing or inhibiting agents. This can lead to a~     significant change in the pharmacokinetics of NOACs, with a decrease or increase~     (respectively) in the level of intestinal absorption, leading to respectively reduced or~     increased plasma concentrations of the drug. Furthermore, there exist genetic mutations of~     Pgp, presenting in particular a lower level of activity than the non-mutated protein. We~     hypothesized that the polymorphisms (mutations) of the ABCB1 gene that codes for Pgp could~     influence plasma concentrations of dabigatran, rivaroxaban and apixaban, and consequently,~     impact on the concentration of NOACs and as a corollary, on the bleeding and thromboembolic~     risk of patients treated with these molecules.~      The main objective of this study is to study the relation between polymorphisms of the ABCB1~     gene that codes for Pgp and plasma concentrations of NOACs in patients treated for a~     hemorrhagic or thromboembolic complication occurring under NOAC therapy.~      Secondary objectives are to evaluate the distribution of ABCB1 polymorphisms among the~     various hemorrhagic risk factors, and to compare the frequency of the polymorphism in~     patients from the study population vs the general population.~   "
111884|NCT02102958|"~     Because people who have both diabetes and visual impairment have high risk for foot problems,~     prevention of ulcers and amputation is a high priority. Usual care in diabetes~     self-management education (DSME) is to teach them to seek sighted assistance for regular foot~     examination, yet clinical experience suggests that this advice is seldom heeded. One possible~     solution is to teach use of the nonvisual senses of touch and smell for a systematic,~     thorough foot self-examination. The purpose of this pilot study was to compare the efficacy,~     acceptability, and feasibility of nonvisual foot examination with usual care (examination of~     the visually impaired person's feet by a sighted family member or friend).~   "
111885|NCT02102945|"~     In the present pilot study, the investigators propose to determine if performing CT perfusion~     scans in post-cardiac arrest patients in coma will help prognosticate the outcome in these~     patients.~   "
111874|NCT02103088|"~     Today prostate cancer (PC) treatment with curative intent is primarily surgical removal of~     the prostate gland (prostatectomy) which may be associated with immediate and long lasting~     erectile dysfunction and decline in urinary function. Besides these physical late effects~     patients operated for PC have a twofold increased risk for depression up to ten years after~     the diagnosis. To reduce these late effects affecting both patient and partner the~     investigators have developed a sexual and urological intervention (PROCAN). The intervention~     is based on epidemiological data, evidence from previous clinical trials, a feasibility study~     and qualitative explorations among PC patients and partners. The investigators hereby suggest~     the conduction of a randomized controlled trial to test the effect of the PROCAN intervention~     on urological and sexual dysfunction, couples adjustment and quality of life. Results of the~     proposed trial may provide clinicians and decision makers with the evidence needed to~     optimize rehabilitation after PC.~   "
111875|NCT02103075|"~     Spinocerebellar ataxia (SCA) is a hereditary disorder with movement incoordination. The~     ataxia performed low intra-cortical facilitation mainly due to the degenerative cerebellum.~     Noninvasive sensory stimulations such as peripheral electrical stimulation were reported to~     modulate the excitability of the motor excitability. Neuromuscular electrical stimulation~     (NMES) was proposed as a neuromodulation tool for the aberrant motor excitability on the SCA.~     This study aims to investigate the effect of NMES on the motor excitability in the SCA, and~     the differentiation on the central or peripheral motor excitability changed by the NMES.~   "
111876|NCT02103062|"~     The purpose of this study is to evaluate the safety and efficacy of Abraxane (nab-paclitaxel)~     in subjects with previously treated metastatic colorectal cancer. Subjects will be placed~     into two separate cohorts based on their RAS mutation status.~   "
111877|NCT02103049|"~     In kidney transplant patients atherosclerosis process is accelerated even in asymptomatic~     patients. This is mainly the consequence of immunosuppressive therapy. Dyslipidemia is~     treated with statins in low doses only as high doses can lead to rhabdomyolysis and are~     therefore contraindicated. As second lipid lowering agent most commonly ezetimibe is used.~     The investigators hypothesise that ezetimibe as a second lipid lowering drug in kidney~     transplant patients lowers LDL cholesterol for additional 10 per cent.~   "
111878|NCT02103036|"~     The purpose of the study is determine whether the Core Stability Exercise is more effective~     than the traditional Back School for low back pain (LBP) in women.~   "
111879|NCT02103023|"~     Influenza poses a heavy burden to our health service. The WHO estimates that seasonal~     influenza causes 250,000-500,000 deaths worldwide each year. Various strategies including~     intradermal vaccination and new vaccine adjuvants have been shown to improve immunogenicity.~     Recently, imiquimod, a synthetic Toll-like receptor 7 (TLR7) agonist useful for the treatment~     of DNA virus infection, have been shown to improve vaccine immunogenicity against influenza~     virus in mouse model. The objective of this prospective double-blind randomized controlled~     trial is to evaluate the effect and safety of topical treatment with imiquimod immediately~     before intradermal influenza vaccination in healthy young adults.~   "
111880|NCT02103010|"~     Radiotherapy is an integral component of the current multimodality treatment approach in~     locally advanced head and neck cancer (HNC). There is growing evidence that more aggressive~     treatment regimens improve tumour control and survival. However, intensified treatment is at~     the expense of increased toxicity, in particular severe acute mucositis. In addition and of~     increasing importance, late and irreversible treatment-related side effects, including~     xerostomia and swallowing dysfunction, occur in a considerable proportion of patients and~     negatively affect quality of life.~      High-risk human papilloma virus (HPV), specifically HPV type-16, is implicated as the~     causative factor in a proportion of HNC, especially those of the oropharynx. HPV-related~     cancers respond well to chemoradiotherapy compared to HNC related to tobacco and alcohol.~     Furthermore, the incidence of HPV-related oropharyngeal cancer is rising in Western~     countries. Given the significant toxicity associated with concurrent chemoradiotherapy,~     subsets of patients could be managed differently.~      The first objective of the project is to develop predictive models for radiation-induced~     dysphagia and xerostomia in HNC patients. Clinical characteristics, treatment parameters,~     dose-volume effects on healthy tissues and whole-genome genetic data will be considered. The~     second objective of the project is to study the prognostic value of HPV status together with~     a panel of tumour biomarkers in oropharyngeal cancer patients. The overall aim of the project~     is to stratify patients according to the risks (side-effects) and benefits (survival) of~     cancer treatment using the developed risk models. Clustering patients into different risk~     categories may aid treatment decision making reducing therapy toxicity without compromising~     survival.~   "
111881|NCT02102997|"~     The DTS.DE registry is an initiative for the collection of high quality process and~     historical data of implantations with the COMBO Dual Therapy Stent in Germany. DTS.DE was~     designed as a national, non- randomized, prospective, multicenter registry without a~     comparison group.~      The responsible Steering Committee is of the opinion that the Combo stent qualifies for~     further documentation of treatment results in the form of a German registry, based the CE~     certification of the COMBO Dual Therapy stent in 2013 and its clinical and scientific~     investigation in the context of the REMEDEE study program, as well as company independent~     externally initiated studies with the COMBO Dual Therapy Stent.~      It is expected that by mid- 2015, at least 1,000 patients will be enrolled and documented in~     the DTS.DE registry with the COMBO Dual Therapy Stent. A clinical follow-up is performed~     after 6 weeks and 12 months.~   "
111882|NCT02102984|"~     Patency duration of covered metal stents as compared with uncovered metal stents in the~     management of malignant strictures of the extra-hepatic biliary tree.~   "
111883|NCT02102971|"~     The investigators would like to study whether Sirtuin 1 (SIRT1) plays a cytoprotective role~     in liver ischemia/reperfusion, and ultimately to develop therapeutic strategies to improve~     hepatic function of patients with liver diseases.~   "
111886|NCT02102932|"~     The aim of the trial is to assess the relative bioavailability of fixed dose combination~     tablets of Empagliflozin and metformin compared to the administration of single tablets~     (Empagliflozin and metformin ) in Chinese subjects. The availability of a fixed dose~     combination tablet is expected to significantly enhance patient's compliance with~     antidiabetic treatment, in particular with concern to the frequent polypharmacy in diabetic~     patients.~   "
111888|NCT02102906|"~     Functional motor disorders, also called motor conversion disorder, are common reasons for~     attendance at neurology outpatient clinics. Patients with functional motor disorders are more~     common than patients with multiple sclerosis and have similar levels of disability but more~     psychological morbidity.~      There is limited evidence for effective treatments in functional motor disorders. A small~     number of studies of transcranial magnetic stimulation (TMS), a painless method of cortical~     stimulation, have reported improvement in functional weakness after this treatment including~     in patients with symptoms of several years duration. The Investigators intend to trial TMS in~     a group of 40 patients with functional motor disorder, randomising patients to immediate or~     delayed treatment and therefore comparing a single session of TMS with routine clinical care.~     The Investigators will also ask patients to undergo tests of attentional focus in a cognitive~     neuroscience laboratory - these experiments will be analysed separately from TMS trial data.~   "
111889|NCT02102893|"~     Neuroendocrine tumors (NETs) are neoplasms originating from neuroendocrine cells located~     throughout the body. They secret various peptides and cause various symptoms (carcinoid~     syndrome) or not. The incidence of NETs was not well-known till recently when Yao et al. and~     Hausa et al. published their surveys of NETs using data from the US Surveillance,~     Epidemiology, and End Results (SEER) program and from the Norwegian Registry of Cancer (NRC).~     The incidence of NETs in Taiwan by using the Taiwan Cancer Registry (TCR) data was increased~     from 0.3 to 1.51 per 100,000 from 1996 to 2008. The increased incidence for NET worldwide~     probably was partially due to the awareness and improvement of diagnostic technology.~     Compared with the incidence in western countries, the incidence of NET is much lower in~     Taiwan. And the incidence of NETs in Asian Pacific Islanders was also lower than the whites~     and blacks in US. Gastroenteral-pancreatic NETs (GEP-NETs), accounting for half to two thirds~     of all NETs, is the most common site of NETs. As the progress in the understanding of~     pathophysiology for GEP-NET, there are two novel targeted agents shown to be effective for~     the treatment of GEP-NET. Meanwhile, response to mTOR inhibitor was better for Asian than~     Caucasian in the phase III study using everolimus for advanced pancreatic NETs. These~     information suggests that there is racial difference for either genetic or environmental risk~     factors and these factors result in different incidence and/or clinical outcome. Currently,~     there is limited data for thorough epidemiologic study in Taiwan. The aim of this study is to~     collect clinical information for GEP-NET, and survey the prognostic factors for GEP-NET in~     Taiwan. We suppose that this epidemiologic study would provide a database potentially to~     improve the diagnosis, and treatment of GEP-NET. This study plans to include 600 GEP-NET~     patients. NET patients diagnosed after 2011.1.1 is included in this study.~      Furthermore, we will provide the check of immunohistochemical staining for the tumor tissue~     of GEP-NET patients, including the functioning status (insulinoma, glucagonoma, gastrinoma,~     VIPoma) and the degree of differentiation, the expression of SSTR2 or SSTR5 and the check of~     possible primary site for unknown primary NET patients. This examination will provide more~     accurate diagnosis for the patients and further treatment suggestion for the patients.~   "
111890|NCT02102880|"~     Age related macular degeneration (AMD) is a multifactorial disease with a strong genetic~     component. Given that it is known that impaired regulation of choroidal vascular tone is~     present in patients with AMD, the current study seeks to investigate whether genetic~     polymorphisms in risk alleles for AMD are associated with altered choroidal blood flow~     regulation in healthy subjects. For this purpose a total of 220 healthy volunteers will be~     included. Choroidal blood flow regulation will be evaluated by measuring choroidal blood flow~     during isometric exercise. In addition, flicker induced vasodilatation will be studied and~     retinal vessel calibers will assessed, as well as retinal thickness and macular pigment~     optical density.~   "
111891|NCT02102867|"~     The purpose of this study is to: (a) adapt existing vaginal USPE items/instruments for~     evaluation of similar elements of rectal compartment use; (b) develop these scales using 3~     distinct semi-solid formulations that represent a range of physicochemical and rheological~     properties of microbicides that are currently being designed for dual compartment use; and~     (c) develop novel USPE instruments to capture the experience of product use in the context of~     receptive anal intercourse (RAI) in both male and female cohorts.~   "
111892|NCT02102854|"~     Rabbit antithymocyte globulin (rATG) is approved for the treatment of acute rejection~     following kidney transplantation and is routinely administered as a series of 5-7 consecutive~     daily doses via central intravenous catheter.Single large-doses of rATG have been shown to~     have equivalent safety and efficacy profile compared to the standard daily protocol when used~     as an induction agent but there are no reported experiences of its use for rejection~     treatment. Plan to study a single-dose rATG infusion compared to standard rATG administration~     including correlation to length of hospital stay and hospital costs.~   "
111893|NCT02102841|"~     The aim of this study is to investigate the mechanisms behind the immune dysfunction that~     occurs in atopic eczema (or atopic dermatitis).~   "
111894|NCT02102828|"~     The Cothera VPulse(tm) mechanical compression device (MCD) combines rapid intermittent~     sequential compression with cold therapy and is designed for single patient use in the home.~     Additionally, it can track patient compliance. This study will examine if there is a~     difference in deep vein thrombosis (DVT) occurrence over 3 weeks after tourniquet-less total~     knee arthroplasty (TKA) and multimodal prophylaxis with or without extended MCD use in a~     cooling device/MCD system.~   "
111895|NCT02102815|"~     To determine efficacy of preoperative IV dexamethasone for postoperative pain control after~     TKA.~   "
111896|NCT02102802|"~     This study measures biological and psychological processes that might help researchers to~     better understand what is taking place during low or medium dose and full dose MDMA-assisted~     psychotherapy treatment in people with PTSD. Heart rate variability (HRV) will be measured up~     to three times; before and once or twice after receiving MDMA-assisted psychotherapy. Brain~     activity will be measured before and after MDMA-assisted psychotherapy in response to~     personalized trauma-related scripts. Participants will complete a measure of self-compassion~     at baseline and two months after a final experimental treatment session. Therapy techniques~     observed during recorded treatment sessions will be classified using a standardized clinical~     measure.~   "
111897|NCT02102789|"~     The primary objective of this study is to determine whether systemic chemotherapy combined~     with hepatic arterial infusion with floxuridine and dexamethasone can increase the complete~     resection rate (R0) and improve the overall survival in patients with initially unresectable~     colorectal liver metastasis.~   "
111898|NCT02102776|"~     The purpose of this randomized multi-center clinical trial is to compare the efficacy and~     safety of intraoperative mitomycin C(MMC),amniotic membrane transplantation(AMT) and~     Conjunctival Autograft(CAG) for primary pterygium surgery. The investigators will also~     evaluate particular risk factors related to pterygium recurrence.~   "
111936|NCT02102282|"~     Patients are managed clinically according to ad hoc standards and scientific knowledge by a~     multidisciplinary team. Clinical decisions are made after a patient physician discussion.~     Blood and tissue samples are collected. Diagnostic, obstetric management surgical treatment,~     systemic treatment, perinatal results and follow up data are collected.~   "
111899|NCT02102763|"~     The purpose of the GRECO study were to: a) to provide national data on overweight and obesity~     prevalence in a representative sample of primary schoolchildren aged 10-12 years old, b) to~     identify those socio-economic, demographic factors, as well as dietary and physical activity~     habits and familial characteristics that are associated with childhood and preadolescent~     overweight and obesity, c) to identify lifestyle and dietary patterns that are associated~     with elevated blood pressure levels and dietary sodium intake.~   "
111900|NCT02102750|"~     The purpose of the study is to examine how preservative free tafluprost ophthalmic solution~     (0.0015%) is distributed in blood circulation after ocular administration in children who~     have glaucoma or elevated intraocular pressure. Tolerance to the drug and safety in general~     will also be assessed.~   "
111901|NCT02102737|"~     Insulin resistance is closely associated with apparition of type 2 diabetes mellitus; it is~     an independent risk factor and predicts future cardiovascular events.~      Hyperinsulinemic euglycemic clamp is a validated method to assessment of insulin resistance~     and It is also the gold standard technique. However, the complexity and length of this~     technique render it unsuitable for routine clinical use.~      In this study, the investigators use a new technique to provide precise, objective, fast and~     automated quantification of insulin resistance with camera SPECT.~      They compare the results with those of the measurement of hyperinsulinemic euglycemic clamp~     in population with or without insulin resistance.~      The proposed study is to validate this new non-invasive imaging technique for evaluation of~     insulin resistance in patients with or without insulin resistance with a comparison with~     hyperinsulinemic euglycemic clamp.~   "
111902|NCT02102724|"~     HIV infection is associated with premature aging of the immune system. It is believe that the~     persistent inflammation that accompanies HIV infection is a major contributor to premature~     immune aging. Fish oil has well-documented anti-inflammatory properties. In this randomized,~     clinical trial, we're testing whether a 12-week course of fish oil supplementation will~     reverse premature aging in HIV-infected older adults.~   "
111903|NCT02102711|"~     Vitamin A is essential for optimal growth, and development. In the newborn, especially if~     preterm, it is necessary for the cellular differentiation, for the health of the anterior~     eye, it is a constituent of visual pigment, and it is essential for surfactant synthesis.~     Immune response Vitamin A supplementation demonstrated to reduces infancy mortality, but very~     low (<1500g birth weight) and extremely low (<1000g birth weight) preterm infants are born~     with low body stores of vitamin A and are at high risk of vitamin A deficiency. Nevertheless,~     optimal vitamin A supplementation for these infants is not clearly defined, despite evidence~     of benefit of an early supplementation.~      Prematurity is associate to the risk for bronchopulmonary dysplasia (BPD) which is a disease~     marked by respiratory compromise associated with high mortality and severe long-term~     morbidity, as well as prematurity is associate to the risk for retinopathy, a pathology that~     may be related to less rhodopsin quantity which seem dependent on vitamin A concentration.~     Vitamin A can be given enterally, intramuscularly, or intravenously. Recently an oral~     administration as drops is available resulting particularly convenient avoiding the pain~     associated with repetitive intramuscular injections, or the discomfort of parenteral~     administration. Studies of vitamin A in the infant population suggest that plasma retinol~     concentrations >0.7 µM/L indicate vitamin A sufficiency, nevertheless preterm infants have~     lower concentration and concentration < 0.35 µM/L are very dangerous. Vitamin A deficiency at~     this level may constitute a problem for preterm newborn, resulting for example, in~     histological alterations in the respiratory epithelium leading to chronic lung disease,~     retinopathy of prematurity, patency of the ductus arteriosis, and immune competence~     deficiency.~      The aim of the present study is to verify efficacy and tolerability of a new oral~     administration of vitamin A as drops, 3000 IU/kg/die for 4 weeks, in infants < 1500g weight~     at birth, verifying the competence of the supplementation reaching ideal blood concentration~     (≥0.7 µM/L) and relating the blood achieved concentrations of vitamin A to the outcome in~     typical pathologies, as BPD and ROP. Not treated group of matched newborn infants is the~     controlarm.~   "
111904|NCT02102698|"~     Tourette's Syndrome is a neurological disease characterized by motor and vocal tics. It has~     been hypothesized that abnormal interactions of dopamine with its receptors may cause the~     tics. The purpose of this study is to test the hypothesis that a drug (ecopipam) that~     selectively blocks dopamine D1/D5 receptors can reduce the frequency and severity of the~     tics.~   "
111905|NCT02102685|"~     The presence of deep abscess in the neck is potentially severe, it can also lead to death in~     short term. The surgical treatment is indicated when there is commitment of the airway,~     critical condition, septicemia, complications, descendent infections, diabetes mellitus with~     no improving during the first 48 hours of parenteral antibiotic treatment and subsequent~     healing of the wounds until it heals by second intention. In this study investigators propose~     the use of vacuum Assisted Closure (VAC) that has been used satisfactorily to reduce edema,~     promote granulation, and ameliorate the tissue to afterwards reconstruct the defect, increase~     vascularity and diminish the bacterial load.~   "
111906|NCT02102672|"~     Pulmonary artery hypertension (PAH) is a chronic and progressive disease that affects 15~     persons per million. Although current therapy has improve disease prognosis, PAH still has a~     poor survival, with a median survival of 2.8 years after diagnosis. In the last few years new~     key elements in PAH pathogenesis have been discovered, such as the role of metabolism in~     disease onset and progression. In fact, PAH pulmonary smooth muscle cells switch into a~     glycolytic phenotype which resembles the metabolism of cancer cells. The investigators~     hypothesis is that fatty acid oxidation inhibition reverts the PAH adverse phenotype by~     restoring mitochondrial function and morphology, decreasing proliferation and restoring~     apoptosis susceptibility in pulmonary smooth muscle cells ~   "
111907|NCT02102659|"~     1. Clinical nutritional support therapy is an important progress of modern medicine.~        2. Conventional methods of clinical nutrition assessment (Anthropometric, lab, etc.) not~          just lack of accuracy and immediacy but also difficult to dynamically reflect the~          fluctuation trend of nutrition status.~        3. It has been reported that malnutrition affects proliferation and apoptosis of human~          cells in vivo. This preliminary study was initiated by the hypothesis that changes in~          nutritional status may be reflected rapidly in fast proliferating cells.~        4. In the previous studies the investigators already found that apoptosis rate of oral~          mucosal epithelium could reflect changes in nutritional status.There were an obvious~          decreasing in apoptosis and proliferation rate of oral mucosal epithelium in~          malnourished patients.~        5. Based on the patient's curve of apoptosis rate of oral mucosal epithelium, the plateau~          being achieved by increase the nutrition amount continuously, Maintain this amount of~          nutrition given until the end of treatment. The investigators call this amount of~          nutrition the upper limit nutrition support therapy.~        6. The patients applying forupper limit nutrition support therapy and Formula nutrition~          support therapy separately, comparing of the two methods influences on postoperative~          wound healing, postoperative complication rate ,inflammatory response, side effects of~          chemotherapy, hospital stays and hospitalization expenses.~   "
111910|NCT02102620|"~     Objective - to evaluate the effectiveness and tolerance of intra-articular injections (IAI)~     of hexacetonide triamcinolone (HT) for the treatment of osteoarthritis (OA) in~     interphalangeal joints.~      Design:randomized, controlled, double-blinded study Materials and methods: sixty patients~     were randomized into: the TH / lidocaine (LD) group (n=30) who underwent IAI at the most~     symptomatic interphalangeal joint with HT (20mg/ml) and LD 2% or the LD group (n=30) who~     received IAI with just LD. Patients were assessed at baseline, 1, 4, 8 and 12 weeks by a~     blinded observer. The following parameters regarding the affected joint were assessed: pain~     at rest (VASr); pain at movement (VASm); pain (VAS) during the 48 hours after the procedure;~     swelling (VASs); goniometry; grip and pinch strength; hand function; treatment improvement;~     daily requirement of paracetamol and incidence and types of local side effects after the~     procedure.~   "
111911|NCT02102607|"~     The primary aim of this study was to determine the median effective dose (ED50) for motor~     block of intrathecally-administered ropivacaine in adults (20-80 years), and to assess the~     effect of age on ED50 required for motor block.~   "
111912|NCT02102594|"~     The aim of this pilot study is to investigate the application of proteasome inhibitor~     Bortezomib (Velcade®, approved for therapy of multiple myeloma) in patients with~     therapy-refractory antibody-mediated autoimmune diseases. The investigators hypothesis is~     that the proteasome inhibition will lead to reduced antibody titers and improved clinical~     outcome.~   "
111913|NCT02102581|"~     To study the short-term effects of tourniquet use in different ways in total knee~     arthroplasty,60 patients were randomly divided into 2 groups (30 cases/group): group A using~     the tourniquet throughout the operation, and group B using the tourniquet starting from the~     implantation of prosthesis to the completion of the operation. Operation time, total measured~     blood loss, intraoperative transfusion volume, and complication were recorded. Hemoglobin~     level was recorded preoperatively and in postoperative 1, 3, 7 and 14 days, and the limb~     circumference, pain score, and knee joint range of motion were also recorded preoperatively~     and in postoperative 3,7 and 14 days.Investigators want to observe the difference between the~     two groups. Hypothesis was made that patients in group B may feel better after operation for~     short time use of tourniquet.~   "
111914|NCT02102568|"~     Prospective multicenter study, Out Health Products that evaluates to 2 years the impact of~     chemo-induced menopause (MCI) on the functional score of quality of life questionnaire~     QLQ-C30 in young women age childbearing and living with breast cancer.~   "
111915|NCT02102555|"~     The purpose of this study is to determine whether a single dose of IV acetaminophen can~     improve post-operative pain, nausea, and vomiting in the outpatient setting. Patient~     satisfaction, time to readiness of discharge, and the amount of opiates post operatively will~     also be measured.~   "
111916|NCT02102542|"~     This observational study was designed to prove clinical efficacy of the well known~     glycopyrrolate which is considered an orphan drug in Thailand. Since the medication has~     never been officially used in Thai people and this particular brand Glyco-P which was made~     in India has never been officially proven of its efficacy in Thai people. The study was aimed~     to prove if this Glyco-P can modestly increase patient's heart rate, decrease secretion and~     safely used in combination with neostigmine for reversal of non-depo muscle relaxant drugs.~   "
111917|NCT02102529|"~     Endometriosis is one of the most frequent benign diseases that can affect women in their~     reproductive age. In severe form, the colon or rectum may be involved. It has been shown that~     the surgical treatment improve typical symptoms like pain and dyspareunia. The investigators~     evaluated the functional results and quality of life after laparoscopic colonic resection for~     endometriosis~   "
111918|NCT02102516|"~     The purpose of this study is to evaluate the pharmacokinetics and safety of postoperative~     administration of SPRIX in pediatric patients (ages 0-11) undergoing open surgical~     procedures.~   "
111919|NCT02102503|"~     Low medication adherence in patients with coronary heart disease increases mortality.~      This study investigates if an intervention of medication review and counselling can improve~     patients' medication adherence and treatment results.~   "
111920|NCT02102490|"~     The main purpose of this study is to evaluate whether the study drug known as abemaciclib is~     effective in treating participants with breast cancer who have already tried other drug~     treatments.~   "
111921|NCT02102477|"~     This prospective, open randomized phase III surgical trial seeks to study whether radical~     prostatectomy (with or without the combination of external radiation) improves~     prostate-cancer specific survival in comparison with primary radiation treatment and hormonal~     treatment among patients diagnosed with locally advanced (T3) prostate cancer. Untreated or~     conservatively treated locally advanced prostate cancer is associated with high mortality.~     Modern curative treatment for advanced solid malign tumors include surgery and/or radiation~     plus attempted chemotherapy if available to achieve both local control and elimination of~     potential micro metastases. Whereas there is evidence that surgery can cure localized~     prostate cancer, there are no clinical trials of multi-modal treatment of locally advanced~     prostate cancer that includes surgical removal of the prostate.~      One potential advantage of adding prostatectomy to the treatment of LAPC is that removing the~     prostate enables a full pathological assessment of the tumor characteristics and thus a~     better estimation of the risk of recurrence. Surgical treatment could thus reduce the numbers~     needed to treat with chemotherapy and radiation, and thus improve quality of life after~     treatment. In addition, evidence indicate that residual cancer in the prostate occurs in 25%~     after radiation treatment (56)and surgical removal of the prostate may improve survival~     beyond what can be achieved by radiation and ADT. On the other hand, patients treated with~     surgery, radiation and hormones will experience side effects of all three treatment~     modalities and might fare better if radiotherapy plus hormones can provide oncological~     control without prior surgery.~      A randomized clinical trial comparing two multimodal treatment regimens of which one includes~     a radical prostatectomy is therefore warranted.~   "
111922|NCT02102464|"~     The pilot study objective is to evaluate the potential benefits of LipiFlow® System treatment~     of contact lens wearers with meibomian gland dysfunction and evaporative dry eye by assessing~     for improvement in meibomian gland function and reduction of dry eye symptoms in comparison~     to an untreated control.~   "
111956|NCT02102022|"~     Assessment of safety and tolerability of ADI-PEG 20 in combination with folinic acid~     (leucovorin), fluorouracil and oxaliplatin (FOLFOX) in advanced GI malignancies.~   "
111923|NCT02102451|"~     The purpose of this study is to evaluate the feasibility of rapid scale-up of new hepatitis C~     (HCV) treatments, known as interferon-free Direct Acting Antiviral (DAA) drugs, and impact on~     the proportion of people with HCV within the HIV-HCV coinfected population of Australia.~      It is hypothesised that a rapid scale-up of hepatitis C treatment with interferon-free~     therapies in individuals with HIV-HCV coinfection will assist in controlling HCV infection in~     this population.~   "
111924|NCT02102438|"~     There is major concern regarding chemotherapy related toxicity in the group of women older~     than 65 years old diagnosed with human epidermal growth factor receptor 2 (HER2) positive~     breast cancer (BC). Nevertheless, these patients are at a particularly high risk of breast~     cancer recurrence and death. Of note, older patients may experience higher risk for~     Trastuzumabe related cardiotoxicity, especially when this agent is combined with an~     anthracycline.~      Recent studies have shown extremely favourable outcomes in early HER2+ BC patients treated~     with a combination of paclitaxel and trastuzumab, omitting anthracyclines from treatment.~      Investigators sought to investigate safety and outcome data on a cohort of elderly patients~     treated with weekly paclitaxel combined with carboplatin and trastuzumab.~   "
111925|NCT02102425|"~     Peritoneal dialysis, known as p- dialysis (PD), is a dialysis form in which the blood is~     purified by using the body's peritoneum. PD dependents on good access to peritoneum. For~     this, a catheter is implanted in the peritoneum and tunneled 2-3 cm below the skin. The way~     out is called exit site and is close to the navel.~      Patients are selected at random to use bandage or not use bandage for three months, then~     cross-over. The overall objective of the research is that the patient in PD maintains a~     complete and healthy skin without signs of infection around the exit site. In the study~     effects by omission of bandage over exit site at patients in PD are examined when the~     patients are in a stable process with PD. The patient's exit site is assessed according to~     skin character and examined for infection.~      The hypothesis is that there is no greater rate of infection in patients without bandage than~     in patients with bandage over the exit site, and that patients without bandage will have~     stronger skin around exit site.~   "
111926|NCT02102412|"~     A single center study intended to evaluate the Aer-O-Scope Colonoscope System.~   "
111927|NCT02102399|"~     The purpose of this study is to verify the effects of two speech-pathology interventions:~     vocal warm-up and respiratory training in teachers who work in a public school of the city of~     Salvador-Bahia, with or without complaints of vocal disorders. It is a preventive study and~     the hypothesis is that both approaches can produce positive voice changes, but the Vocal~     Warm-up will produce the most significant changes.~   "
111928|NCT02102386|"~     The goal of this study is to demonstrate Or-Nim's CerOx monitor ability to monitor changes in~     cerebral blood flow and oximetry during CEA surgery.~      Procedures include:~      Screening:~      ECG, blood draw, neurological assessment, NIHSS~      study: CerOX and TCD clock during CEA procedure, data collection from the medical~     record/monitors, neurological assessment, NIHSS~      30 day follow-up~   "
111929|NCT02102373|"~     Colonoscopy is a routinely performed procedure in children and adolescents. Proper~     visualization of the intestinal mucosa is highly dependent on the quality of the bowel~     preparation. European Society of Gastrointestinal Endoscopy (ESGE) emphasizes that the timing~     of bowel preparation is the key factor and recommends that the delay between the last dose of~     bowel preparation and colonoscopy should be minimized. Timing of bowel preparation prior to~     colonoscopy has not been studied in children population, yet. The diet regimen before~     colonoscopy is likely less important than the timing of bowel preparation, however may~     influence the well-being of children.~   "
111930|NCT02102360|"~     This clinical study compared a conventional surgical technique (CST) and a minimally invasive~     surgical technique (MIST) in the regenerative treatment of mandibular furcation defects.~   "
111931|NCT02102347|"~     The aim of the proposed study is to analyze the effect of the incorporation of phototherapy~     into a therapeutic exercise program on pain, functional capacity, range of motion, muscle~     strength in individuals with osteoarthritis of the knees. The participants will be allocated~     to different groups through a randomization process using opaque envelopes containing cards~     stipulating one of the three following groups: Group A (exercise protocol); Group B (exercise~     protocol + phototherapy protocol); and Group C (exercise protocol + placebo phototherapy~     protocol). Phototherapy will be performed on the knees diagnosed with osteoarthritis.~   "
111932|NCT02102334|"~     In total hip arthroplasty (THA), radiographic preoperative planning and postoperative~     evaluation of acetabular component, femoral offset (FO) and leg length discrepancy (LLD)~     require good validity, interobserver reliability and intraobserver reproducibility.~      Questions/purposes: (1) Evaluate the validity of the Sundsvall method of FO measurement by~     comparing it to a standard FO measurement method. (2) Evaluate the interobserver reliability~     and intraobserver reproducibility of measurement of FO, LLD, acetabular cup inclination and~     anteversion.~      90 patients with primary unilateral osteoarthritis (OA) were included in this prospective~     study. On postoperative radiographs FO by the Sundsvall method, FO by a standard method, LLD,~     acetabular cup inclination and anteversion were measured. The interobserver reliability and~     intraobserver reproducibility were made by three independent observers. The validity and~     degree of prediction of Sundsvall method are measured by comparing its results with the~     standard method.~   "
111933|NCT02102321|"~     Treatment of hookworm infected groups with albendazole has been shown to result in an~     increase in hemoglobin levels and a related decrease in the prevalence of anemia. Increases~     in hemoglobin levels due to treatment have been associated with significant gains in adult~     labor productivity.~      In this study, the investigators hypothesize that regular treatment of women smallholder~     farmers in a high prevalence area with the anti-hookworm drug albendazole and iron~     supplementation will improve hookworm associated anemia. Further, regular treatment of~     albendazole and iron supplementation will improve their work capacity when compared to a~     control group~   "
111934|NCT02102308|"~     A 12-week multicomponent exercise is effective in improving executive function and gait~     performance in dual-task conditions.~   "
111935|NCT02102295|"~     The purpose of this study is to investigate the effect of a dentifrice containing L-ascorbic~     acid 2-phosphate magnesium salt on gingival inflammation, gingival bleeding and gingival~     redness.~   "
111937|NCT02102269|"~     Shoulder pain is frequently reported as a complication among stroke patients. Muscular~     imbalance disrupts stability of the glenohumeral joint creating a subluxation. Stretching the~     soft tissue can cause shoulder pain which impedes quality of life, length of stay and~     rehabilitation outcome. To align the humeral head in the cavitas glenoïdalis a shoulder~     orthosis is often provided to the patient. Since the use of these orthoses is not always~     considered positive by the patient nor the therapist the question rises if the investigators~     can objectify if the subacromial space is reduced when wearing a sling.~      Sonography is a valid way to asses subluxation of the shoulder joint by measuring the~     subacromial space. To objectify if an orthosis can reduce the enlarged subacromial space the~     investigators will use sonography to measure the distance between acromion and greater~     tuberosity are between acromion and the humeral head. This distance will be measured with and~     without the orthosis and also after a period of at least 4 hours of wearing the orthosis.~     This last measurement might inform us about how long the orthosis can correct the~     glenohumeral position. To validate the sonographic measurement X-rays will be taken by a~     sample of the investigators study population to compare with the ultrasound data.~      Two different orthoses will be compared. First of all the actimove sling, which is standardly~     used in the rehabilitation centre where patients will be recruited. This sling can be adapted~     by the patient itself and is very easy to wear. The disadvantage is that the elbow is~     continuously flexed, which enlarges the risk on contractures of m. biceps and m.~     brachioradialis. Also the negative influence on the interpretation of the body scheme and on~     the quantitative use of the arm can be reasons not to wear this kind of orthosis. The~     shoulderlift on the other hand is a newly developed orthosis which supports the shoulder~     joint with the arm extended. This is a more normal position during the daily living and~     stimulates the use of the paretic arm. An extra adaptation can be adjusted to make it~     possible to position the arm flexed in order to reduce oedema of the hand if necessary. The~     control group does not wear any orthosis at all.~      Additional the investigators will evaluate passive range of motion of the shoulder,~     spasticity of the upper limb (modified ashworth scale), active motion of the upper limb (fugl~     meyer assessment) and trunk stability (Trunk Impairment Scale) at starting point and after a~     period of 6 weeks wearing the orthosis minimal 6 hours a day.~      If possible the investigators will do an evaluation of balance on a moving platform and an~     evaluation of gait with and without the orthosis after 6 weeks to assess the impact of on~     balance and gait.~   "
111938|NCT02102256|"~     Current treatment options for bilateral profoundly deaf children, diagnosed with inner ear~     anatomical abnormalities, are limited and, in the case of absent cochleas, non-existent. An~     auditory brainstem implant (ABI) places an electrode close to the auditory nucleus in the~     brainstem. Children aged 2 - 5 who are not candidates for a cochlear implant, or who did not~     demonstrate benefit from a cochlear implant, will be implanted with an ABI and followed for 1~     year for safety and a total of 3 years for preliminary efficacy. This is a feasibility study~     to determine the safety of the ABI.~   "
111939|NCT02102243|"~     Patients with high aldosterone hormone have higher blood glucose than normal people. This~     study is being done to understand how aldosterone hormone affects the nerve activity that~     controls blood flow in the muscles and blood glucose. The information may be helpful in~     selecting blood pressure medications which can improve not only blood pressure but also~     improve blood sugar.~   "
111940|NCT02102230|"~     The purpose of this study is to investigate the efficacy of a group-based behavioral sleep~     intervention, and the incremental benefit provided by an adjunct sleep mobile app, on~     cannabis and sleep outcomes among cannabis dependent Veterans.~   "
111941|NCT02102217|"~     20% of patients who undergo major abdominal surgery will have a major complication, which~     requires invasive treatment and is associated with increased mortality, morbidity, hospital~     stay and intensive care stay. A quality control algorithm after Major Abdominal Surgery (MAS)~     aimed at early identification of patients at risk of developing major complications can~     decrease associated morbidity and mortality. Literature studies show promising results for~     C-reactive protein as an early marker for postoperative complications, however clinical~     significance has yet to be determined. Here the investigators propose a randomized clinical~     trial in order to determine the effect of postoperative monitoring with standardized CRP~     measurements on postoperative morbidity and mortality, if CRP levels exceed 140 mg/L~     additional CT-scan imaging will be conducted.~   "
111942|NCT02102204|"~     This is a multicenter, single-arm, extension study to characterize the long-term safety and~     tolerability of etelcalcetide in the treatment of Secondary Hyperparathyroidism (SHPT) in~     adults with Chronic Kidney Disease (CKD) on hemodialysis.~   "
111943|NCT02102191|"~     Because e-cigarettes do not contain or burn tobacco, they do not appear to deliver the known~     toxins found in conventional cigarette smoke.However e-Cigarettes with low dose of tobacco~     were found to have immediate adverse physiologic effects after short-term use that are~     similar to some of the effects seen with tobacco smoking.~      In this study we wanted to assess the short-time effect of one e-cigarette with no tobacco vs~     a traditional cigarette.~      10 n-smoking subject and 10 actual smokers will be enrolled in the randomized trial.~   "
111944|NCT02102178|"~     Pain is one of the most incapacitating symptoms because it is a complex experience that~     includes sensory and emotional perceptions, in which sensory, affective, cognitive,~     behavioral, cultural and social characteristics interact. Around 79% of advanced cancer cases~     present pain.~      There is evidence that non-pharmacological therapeutic activities are useful for controlling~     oncological pain and other symptoms resulting from such diseases.~      This study evaluated the results relating to pain modulation and improvement of emotional~     symptoms and quality of life, from an occupational therapy program applied to oncological~     patients who were receiving palliative care.~   "
111945|NCT02102165|"~     This program initially aims to recruit 1300 breast cancer patients from a large number of~     hospitals across Europe. Eligible patients are those who are 18 or older, either female or~     male, and who have not received more than 1 type of treatment from the time metastases were~     discovered, metastasi(e)s has just been diagnosed or their disease has come back (disease~     relapse). Biopsy samples from both the primary and metastatic (or relapsed) tumor will be~     collected for central analyses, together with blood, serum and plasma samples. Any samples~     not analyzed immediately will be stored in an independent bio-repository to enable future~     (not yet defined) research aimed at better understanding metastatic breast cancer.~      In summary, the main objectives of AURORA are to better understand the genetic aberrations in~     metastatic breast cancer and to discover the mechanisms of response or resistance to therapy,~     in order to ultimately identify the right therapy for each individual patient. At the same~     time, patients with genetic aberrations that are being targeted by new drugs in development~     will be offered the possibility to participate in clinical trials, when approved and~     available in their countries. Ultimately, the aim of AURORA is to improve the outcomes of all~     patients diagnosed with metastatic breast cancer.~   "
111957|NCT02102009|"~     The purpose of this study is to determine whether nutritional support with a complete formula~     is effective to improve malnutrition and respiratory function in patients with chronic~     pulmonary disease compared to the standard hospital dietary advise.~   "
114141|NCT02073448|"~     This study is to demonstrate the superiority in efficacy of the GK530G (fixed combination of~     CD0271 0.1% and CD1579 2.5%) versus each of the monads (CD0271 0.1% and CD1579 2.5%) in the~     treatment of acne vulgaris for up to 12 weeks, in the Japanese patients.~   "
111946|NCT02102152|"~     The use of inhaled medications for the treatment of pulmonary diseases allows for the~     delivery of a high concentration of a drug at the site of disease with reduced systemic~     absorption and risk of systemic adverse effects. Inhaled Tobramycin has been successfully~     used in the maintenance treatment of CF patients with chronic colonization with PA~     (Pseudomonas aeruginosa). In the CF population TOBI has been proven to improve lung~     functions, decrease the density of the PA in the sputum, decrease hospitalizations, and~     reduce the risk of mortality.~      Non CF Bronchiectasis share many features in common with CF, including frequent colonization~     with PA that leads to deterioration in lung function and increased morbidity. A recent~     Cochrane review concluded that there is a small benefit for the use of prolonged antibiotics~     in the treatment of bronchiectasis, however further randomized controlled trials with~     adequate power and standardized end points are required.~      There have been reports in the literature describing the efficacy of inhaled tobramycin the~     treatment of patients with non CF bronchiectasis with eradication of PA, and significant~     improvement in respiratory symptoms. There were however patients who discontinued treatment~     due to adverse events most commonly cough wheezing and dyspnea. (Scheinberg and Shore, Chest~     2005).~      TOBI Podhaler is a dry powder inhaler that was recently launched, and is much easier and~     faster to use compared to nebulised Tobramycin. To the best of our knowledge Tobramycin dry~     powder formulation has not yet been trialed in patients with non CF bronchiectasis.~      The purpose of this trial is to assess the efficacy and tolerability of TOBI Podhaler in~     patients with non CF bronchiectasis, and to gather more data on the benefit of continuous~     antibiotic therapy in patients with non CF bronchectais.~   "
111947|NCT02102139|"~     Percutaneous tunnelling (hydrodissection) in the neck and anterior chest in patients~     undergoing robotic thyroidectomy leads to significant haemodynamic responses such as~     increases in blood pressure and heart rate. The investigators evaluated whether a single~     preoperative dexmedetomidine injection attenuated the haemodynamic responses to~     hydrodissection by reducing the half-maximal effective concentration (EC50) of remifentanil~     needed to maintain haemodynamic stability during hydrodissection.~   "
111948|NCT02102126|"~     The ENSURE study is a multi-center, prospective, single-blind, randomized, controlled study~     of the effect of renal denervation on arterial stiffness and haemodynamics in subjects with~     uncontrolled hypertension. Bilateral renal denervation will be performed using the catheter,~     delivering radiofrequency energy through the luminal surface of the renal artery.~   "
111949|NCT02102113|"~     The overall purpose of this study is to determine whether a family history of psychosis is~     associated with an altered cannabinoid system. This will be tested by studying individuals~     with and without a family history of psychosis and comparing their responses to delta~     9-tetrahydrocannabinol (THC), a probe of the cannabinoid system. We hypothesize, that~     compared to controls with no family history of psychoses, individuals with a family history~     of psychoses will have an altered response to THC.~   "
111950|NCT02102100|"~     This study will help determine if menthol administered by inhalation via electronic~     cigarettes (e-cigarette) changes the reinforcing effects of pure nicotine administered~     intravenously in cigarette smokers who smoke mentholated or non-mentholated cigarettes.~   "
111951|NCT02102087|"~     This is a matched, open label study to evaluate the Initial Specimen Diversion Device (ISDD)~     in reducing the contamination rate in blood culture analysis. Blood culture data will be~     derived from inpatient and/or outpatient settings in a variety of hospital departments (e.g.~     ER, surgical, medical, etc.). Only samples that are collected via peripheral venipuncture may~     be included in this study. The ISDD will be compared to current laboratory practices for the~     collection of blood for culture purposes. Laboratory Standard Procedures (LSP) is defined as~     collection of venipuncture blood for culture without an initial diversion method to divert~     and sequester potential blood contaminants.~   "
111952|NCT02102074|"~     The investigators hypothesize that the presence of tumor cells and tumor markers in~     peritoneal cavity are indicative for peritoneal spread during surgery, and may serve as early~     markers for systemic and/or intra-peritoneal recurrence of the disease and ultimately improve~     our understanding of tumor spread and disease recurrence.~   "
111953|NCT02102061|"~     The present study aims to explore the effects of a novel multidisciplinary~     non-pharmacological intervention designed to improve health parameters and well-being in~     overweight and obese women. The proposed program is health- and quality of life-oriented,~     without a focus on weight loss, following the philosophical principles from Health at Every~     Size, and may provide an alternative mode of intervention to the traditional one, which is~     focused on the concept of weight loss at any cost. To evaluate the efficacy of the~     intervention, a mixed-method design combining both qualitative and quantitative assessments~     will be applied.~   "
111954|NCT02102048|"~     The association between HIV infection , insulin resistance and diabetes mellitus is the topic~     of many studies that have attempted to analyze the problem from different points of view. In~     fact, the risk of insulin resistance in HIV-positive patients on antiretroviral therapy seems~     to depend not only on the same factors that determine its incidence in the general population~     , but also on the effects of antiretroviral therapy on glucose metabolism. To confirm this~     observation, studies that have evaluated the incidence of diabetes in patients with HIV~     infection on antiretroviral therapy have shown that the incidence of diabetes in infected~     individuals is significantly higher than that observed in the uninfected population. Moreover~     others preliminar stadies observed that protease inhibitors may induce hyperglycemia and~     diabetes mellitus. Anyway at this moment no large data are available that indicate the~     utility to modify the antiretroviral therapy in HIV positive patients with a damage of~     glucose metabolism.~      ATAGLU is a cohort composed by HIV positive patients in effective and stable combined~     antiretroviral therapy (cART) with undetectable viral load. All patients studied had carried~     out a therapy with Lopinavir/Ritonavir (LPV/r) + optimal backbone therapy (OBT) and then in~     part switch to Atazanavir (ATV) + OBT or Atazanavir/ritonavir (ATV/r) + OBT , in part~     continue with LPV/r + OBT .~      The objective was to characterize the changes of carbohydrate profile of a cohort of patients~     who made a switch from a regimen with LPV/r to boosted or unboosted ATV.~   "
111955|NCT02102035|"~     Reconstruction of soft tissue defects in the fingers continues to be a challenge problem. The~     study reports reconstruction of small to moderate defects of the fingers with the direct and~     reversed dorsal digital island flaps and evaluates the results of the use of the flaps.The~     main outcomes are static 2-point discrimination and Semmes-Weinstein monofilament scores of~     the flap and joint motion.~   "
111958|NCT02101996|"~     The average American diet consumed by a significant proportion of the adult population,~     supplies excessive calories and large amounts of saturated fat. Saturated fats can be cleared~     and used in skeletal muscle, but in obese individuals, biomarkers of saturated fat are found~     in the blood, along with markers of poor muscle metabolism.~      Both fats and amino acids are processed by the same metabolic pathways in muscle, and the~     investigators hypothesize that meals with greater amounts of saturated fat slow muscle~     metabolism. A better understanding of the interaction of these to metabolites will allow for~     the development of future medications to treat muscle loss in sick individuals and the~     elderly.~   "
111959|NCT02101983|"~     High-dose cytarabine (HiDAC) is considered a standard chemotherapy treatment for patients~     with acute myeloid leukemia. However, most patients receiving this therapy are required to be~     admitted to the hospital during their treatment course.~      The purpose of this study is to compare the safety and cost of high-dose cytarabine treatment~     given in an in-patient setting versus an out-patient setting.~   "
111960|NCT02101970|"~     The purpose of this study is to determine if high dose supplementation with the omega-3 fatty~     acids EPA and DHA, when added to a weight loss program, is well tolerated in the study~     population and if there is an increase in the favorable change in blood and tissue breast~     cancer risk factors when compared to weight loss alone.~   "
111961|NCT02101957|"~     The purpose of this study is to evaluate the effect of cysteamine in patients with~     symptomatic Huntington's disease by comparing two groups of patients (cysteamine vs placebo)~     on the results of the Unified Huntington's Disease Rating Scale (UHDRS, Huntington study~     group 1996).~   "
111962|NCT02101944|"~     This pilot phase I clinical trial studies the side effects and best dose of wild-type~     reovirus when combined with carfilzomib and dexamethasone in treating patients with multiple~     myeloma that has come back following treatment or does not respond to treatment. Drugs used~     in chemotherapy, such as dexamethasone and carfilzomib, work in different ways to stop the~     growth of cancer cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. A virus called wild-type reovirus may be able to kill cancer~     cells without damaging normal cells and seems to work best when given with chemotherapy.~     Giving wild-type reovirus with chemotherapy may be a more effective treatment than~     chemotherapy alone.~   "
111963|NCT02101931|"~     Research Problem:~      Bladder cancer is one of the major health concerns of the world. The present methods of~     diagnosis are: Ultra sound, Cystoscopy, CT scan and urine cytology. All these are stressful~     to the patients, particularly Cystoscopy which is commonly employed for the follow up of~     Bladder cancer patients.~      Research Significance:~      The present study will employ a new photodynamic diagnostic procedure to quantify a certain~     cancer specific biomarker called Porphyrin, which selectively binds on to the bladder cancer~     tissues. In this context the present technique offer viable, very easy and reliable table top~     instrumentation for diagnosis and continual monitoring of disease regression through urine.~      Research Objectives:~        -  To quantify bladder cancer specific biomarkers such as Porphyrin using photodynamic~          diagnostic procedure~        -  To find out whether this technique might be a new and easy tool for bladder cancer~          diagnosis only by urine.~      Research Methodology:~      The bladder cancer patients is required to swallow a chemical called ALA (5 Amino levulinic~     Acid hydrochloride), about 10mg/kg body weight which will play a role of biological~     indicator. ALA gets metabolized into certain types of porphyrins which selectively bind on to~     the tumor tissues (for a longer time than the normal tissues). 5ml of blood and one urine~     samples will be taken before using ALA. The patient must drink water then the urine will be~     collected after 4, 8 and 12 hours of taking ALA and the samples will be analyzed by~     photodynamic diagnostic procedure.~   "
111964|NCT02101918|"~     This phase II trial studies ziv-aflibercept in treating and perfusion computed tomography~     perfusion imaging in predicting response in patients with pancreatic neuroendocrine tumors~     that have spread to other parts of the body or cannot be removed by surgery. Ziv-aflibercept~     may stop the growth of tumor cells by blocking blood flow to the tumor. Diagnostic~     procedures, such as computed tomography perfusion, imaging may help measure a patient's~     response to ziv-aflibercept treatment.~   "
111965|NCT02101905|"~     This pilot clinical trial studies how well lapatinib ditosylate before surgery works in~     treating patients with high-grade glioma that has come back after a period of time during~     which the tumor could not be detected. Lapatinib ditosylate may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth.~   "
111966|NCT02101892|"~     A major reason for the substantial underuse of pharmacological prevention of migraine is its~     inadequate efficacy, since only ~50% of patients respond to a specific agent. There is~     currently no evidence-based way to identify the patients that will respond to a specific~     preventive treatment. Amitriptyline is one of the commonest agents used for migraine~     prevention, strengthening patient's pain inhibitory capacity. Individual tailoring of~     analgesics according to pain inhibitory capacity has been shown effective by our group for~     painful diabetic neuropathy patients. Specifically, patients with reduced pain inhibition~     capacity gained more from a drug that augment pain inhibition as compared to those with~     efficient inhibitory capacity. The investigators now propose to assess migraineurs for their~     pain inhibition capacity, and examine whether, along similar reasoning, those with reduced~     inhibitory capacity are the ones more likely to respond to amitriptyline. Psychophysical and~     neurophysiological dimensions of pain inhibitory modulation will be assessed in migraineurs,~     who will, subsequently, receive either amitriptyline or placebo for 8 weeks, in a randomized~     two arms parallel double blind design, and followed up for attacks reduction. The~     investigators expect to identify the best predictors for efficacy of migraine prevention by~     the study drug. This approach will promote individualization of migraine therapy.~   "
112023|NCT02101151|"~     The incidence of type 2 diabetes mellitus and obesity is increasing at an alarming rate both~     nationally and worldwide. Accumulating evidence suggests that serum cholecalciferol levels~     may be inversely related to the prevalence of diabetes, insulin resistance and metabolic~     syndrome. However, to demonstrate a causal relation between vitamin D and glucose metabolism,~     evidence from randomized and adequately powered placebo-controlled intervention trials is~     needed.The trials available on the effect of Vitamin D supplementation are not conclusive.~     Hence, the purpose of this study was to conduct a double-blind randomized trial in Vitamin D~     deficient obese type 2 diabetic Emirati population to clarify the effect of vitamin D~     supplementation on glycemic control and obesity parameters.~   "
111967|NCT02101879|"~     Approximately 15-25% of all breast cancers are human epidermal growth factor receptor 2~     (HER2) positive and it has been well known that HER2 overexpression is associated with more~     aggressive phenotype and poor prognosis with resistance to certain chemotherapeutic agents.~      Trastuzumab administration as an adjuvant and in metastatic HER2 positive breast cancer is~     associated with both symptomatic and asymptomatic cardiotoxicity. The incidence of~     trastuzumab-mediated cardiotoxicity were 27% with antracycline combination and 13% when it~     was administered with paclitaxel .~      Pertuzumab, a recombinant humanized monoclonal antibody binding to the HER2 dimerization~     domain, prevents dimerization of HER2 with other HER receptors (HER3,HER1, and HER4)~     especially with HER3. Blocking HER2-HER3 dimerization is postulated to be the most clinically~     relevant action of pertuzumab and this can effectively block her2-mediated cell signaling.~      Pertuzumab is indicated in combination with trastuzumab and docetaxel for the treatment of~     patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2~     therapy or chemotherapy for metastatic disease.~      Treatment of breast cancer with pertuzumab plus trastuzumab plus docetaxel as first line~     treatment until disease progression might be complicated by cardiotoxicity in up to 14.5% of~     the Patients.~      Cardinale et al showed that troponin I (TNI) positive identifies trastuzumab-treated patients~     who are at risk for cardiotoxicity and are unlikely to recover from cardiac dysfunction~     despite HF therapy.~      There is very little data about the reversibility and identification of patients at risk for~     cardiotoxicity of the pertuzumab plus trastuzumab plus docetaxel regimen and of those who~     will not recover from cardiac dysfunction,this information is crucial. The usefulness of~     troponin I (TNI) and Brain natriuretic peptide (BNP) in the identification of patients at~     risk for PT cardiotoxicity and in the prediction of LVEF recovery has never been~     investigated.~      based on this background , this study aim is to evaluate the cardiotoxicity of pertuzumab~     plus trastuzumab plus docetaxel regimen and the application of troponin I (TNI) and Brain~     natriuretic peptide (BNP) in this setting.~   "
111968|NCT02101866|"~     This Phase 1 study aims to determine the oral bioavailability of a single dose of a new~     vapendavir tablet formulation and compare it to that of the previous vapendavir capsule~     formulation. The safety of both drug products will also be assessed.~   "
111969|NCT02101853|"~     This randomized phase III trial studies how well blinatumomab works compared with standard~     combination chemotherapy in treating patients with B-cell acute lymphoblastic leukemia that~     has returned after a period of improvement (relapsed). Monoclonal antibodies, such as~     blinatumomab, may interfere with the ability of tumor cells to grow and spread. It is not yet~     known whether standard combination chemotherapy is more effective than blinatumomab in~     treating relapsed B-cell acute lymphoblastic leukemia.~   "
111970|NCT02101840|"~     The objective of this study is to examine the abuse liability of a single 40mg dose of 2~     controlled release oxycodone formulations (Apo-Oxycodone CR® and OxyNEO®) in non-dependent~     recreational opioid users by assessing the self-reported acute effects of the drugs and~     taking blood samples to measure drug concentrations. The investigators think there may be~     differences in how well these drugs are liked when swallowed whole due to differences in how~     the products are formulated.~   "
111971|NCT02101827|"~     To evaluate the safety and efficacy of manual syringe-infusion method in hysteroscopic~     procedures.~   "
111972|NCT02101814|"~     The prevalence of obesity is steadily growing in many parts of the world in order to reach~     epidemic proportions. Changes in signaling pathways state of hunger and satiety contribute to~     the increase in obesity and metabolic syndrome. Currently, the white adipose tissue, also is~     considered a secretory tissue by producing numerous adipokines involved in a chronic state of~     inflammation, which may interfere with the neuroendocrine regulation of energy balance that~     affect the weight loss process. The bariatric surgery is recommended as the most effective~     tool in the treatment and control of morbid obesity. The study population will consist of~     patients undergoing bariatric surgery of type Roux-en-Y gastric bypass. The study was~     performed in Clinical Hospital of the Federal University of Paraná (UFPR). This is a~     prospective cohort study with follow up of 6 and 24 months. The aim of this study is to~     assess the effects of weight loss after bariatric surgery associated anthropometric~     characteristic, metabolic changes (glucose, cholesterol profile,hepatic enzymes, Fibroblast~     growth factor- 21(FGF-21), blood pressure), the profile of adipokines pro/anti-inflammatory~     (adiponectin, interleukin-6 (IL-6),interleukin-10 (IL-10), C reactive protein (CRP),~     plasminogen activator inhibitor-1 (PAI-1), tumor necrosis factor alpha (TNF-α), intercellular~     adhesion molecule-1 (ICAM-1), resistin, frizzled-related protein 5 (SFrp5) and neuroendocrine~     regulation of energy balance (leptin, neuropeptide Y (NPY) , alpha-melanocyte stimulating~     hormone (α-MSH), melanin-concentrating hormone (MCH) and agouti-related peptide (AgRP), as~     well as the quality of life in obese adults.~   "
111973|NCT02101801|"~     Over 60% of crops in Israel are grown in recycled treated waste water. This study aims to~     determine whether minute quantities of drugs such as Carbamazepine can be found in~     individuals who ingest vegetables grown in waste water.~   "
111974|NCT02101788|"~     This randomized phase II/III trial studies how well trametinib works and compares it to~     standard treatment with either letrozole, tamoxifen citrate, paclitaxel, pegylated liposomal~     doxorubicin hydrochloride, or topotecan hydrochloride in treating patients with low-grade~     ovarian cancer or peritoneal cavity cancer that has come back, become worse, or spread to~     other parts of the body. Trametinib may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth. It is not yet known whether trametinib is more effective~     than standard therapy in treating patients with ovarian or peritoneal cavity cancer.~   "
111975|NCT02101775|"~     This randomized phase II clinical trial studies how well gemcitabine hydrochloride and WEE1~     inhibitor MK-1775 work compared to gemcitabine hydrochloride alone in treating patients with~     ovarian, primary peritoneal, or fallopian tube cancer that has come back after a period of~     time. Gemcitabine hydrochloride may prevent tumor cells from multiplying by damaging their~     deoxyribonucleic acid (DNA, molecules that contain instructions for the proper development~     and functioning of cells), which in turn stops the tumor from growing. The protein WEE1 may~     help to repair the damaged tumor cells, so the tumor continues to grow. WEE1 inhibitor~     MK-1775 may block the WEE1 protein activity and may increase the effectiveness of gemcitabine~     hydrochloride by preventing the WEE1 protein from repairing damaged tumor cells without~     causing harm to normal cells. It is not yet known whether gemcitabine hydrochloride with or~     without WEE1 inhibitor MK-1775 may be an effective treatment for recurrent ovarian, primary~     peritoneal, or fallopian tube cancer.~   "
111976|NCT02101762|"~     The Foley catheter is one component in a catheter insertion procedure that could contribute~     to a catheter associated urinary tract infection (CAUTI). Improvement in the catheter~     insertion procedures using the ERASE CAUTI Tray system may help to lower these infection~     rates.~   "
111977|NCT02101749|"~     This is a prospective, Open label randomized study. A total of 220 adults aged ≥ 60 years~     will be enrolled and randomized to one of 2 study arms:~        1. Seasonal inactivated intradermal influenza vaccine (15 μg HA (hemagglutinin) per strain/~          0.1 ml dose) (group A - 110 participants)~        2. Seasonal inactivated intramuscular influenza vaccine (15 μg HA per strain/ 0.5 ml dose)~          (group B - 110 participants) Groups A and B will receive the vaccine at day 1. Total~          follow up period is 60 days.~   "
111978|NCT02101736|"~     This study, A Phase II Study of Cabozantinib (XL l84) for Plexiform Neurofibromas in~     Subjects with Neurofibromatosis Type I Age 16 years or greater is for participants that have~     been diagnosed with Neurofibromatosis Type 1 (NF1) and have a type of tumor called a~     plexiform neurofibroma. Neurofibromas are tumors that develop from the cells and tissues that~     cover the nerves. Plexiform neurofibromas can be disfiguring, painful, and life-threatening.~     These types of tumors typically do not respond well to most treatment approaches such as~     chemotherapy, radiation, and surgery because of their slow growth and location near vital~     structures of the body such as nerves, blood vessels, and the airway.~      The purpose of this Phase II Study is to determine the response rate of NFI patients with~     plexiform neurofibromas treated with Cabozantinib therapy using MRI scans. Cabozantinib is~     thought to work on tumors by blocking pathways that are involved in the growth of tumors and~     blood vessels that supply tumors. Cabozantinib is considered experimental because it has not~     been approved by the Food and Drug Administration (FDA).~   "
111979|NCT02101723|"~     The investigators propose to study the effects of increased iron intake by home fortification~     of complementary foods on the gastrointestinal microbial development, inflammatory responses,~     and zinc (Zn) absorption. The proposed subjects are 9 month olds living in a malaria endemic~     area of rural Kenya who are randomized at 6 months of age to one of three fortificant groups:~     1) Sprinkles™ with 12mg Iron(Fe)/day + other micronutrients, including 5mg/d Zn (test);~     Sprinkles™ with 0 mg/d Fe + other micronutrients, including 5mg/d Zn (control); Sprinkles™~     with no micronutrients (placebo). The investigators hypothesize that the microbiome will be~     significantly different in the three groups and that Zn absorption and status, in addition to~     immune and oxidant status will be improved in the non-Fe fortified groups when compared to~     the Fe-fortified group.~   "
111980|NCT02101710|"~     This study it to evaluate the bioequivalence of Elantan SR 60 mg compared to Imdur SR 60 mg~     in sixty healthy Korean male subjects.~   "
111981|NCT02101697|"~     This Randomized Controlled Trial has been designed to test the efficacy of a behavioral~     intervention to reduce HIV-related stigma among nursing students and ward attendants in 16~     sites in South India and 8 sites in North India.~   "
111982|NCT02101684|"~     Granulosa Cell ovarian carcinoma is an infrequent subtype of neoplasia well differentiated~     from epithelial tumors. They account for 5% of all ovarian malignancies and, with an~     incidence of 0.4-1.2 cases per 100000 habitants, is considered as a rare disease.~      Though most cases are identified at initial stages and can be cured through surgical~     resection, distant recurrences have been documented even 10 years after resecting the primary~     tumor. At advanced stage it is a lethal disease.~      Unfortunately because of the low incidence of this disease randomized clinical trials are~     lacking. In fact current evidence for treatment is provided by case reports, retrospective~     studies and phase II clinical trials performed one decade ago.~      Orteronel, a novel, orally active, selective inhibitor of 17,20-lyase, is being developed as~     an endocrine therapy for relevant hormone-sensitive cancers such as prostate cancer and~     breast cancer. Orteronel is expected to suppress sex hormone levels in both circulation and~     relevant hormone-dependent malignant tissue. Since sex hormone overproduction has been~     demonstrated in granulosa cell ovarian tumors and seems to play a major role in this disease,~     this study will assess the efficacy or orteronel treating such tumors.~   "
111983|NCT02101671|"~     The purpose of this study is to determinate if the patients submitted to laparoscopic surgery~     in trendelemburg position develope more inadequate anaesthesic emergence than patients~     submitted to laparoscopic surgery in other positions.~   "
111984|NCT02101658|"~     The purpose of this project is to examine potential bias or expectancies in individuals'~     measurement and recording of weight in a clinical-research setting.~   "
111985|NCT02101645|"~     The research group will choose no more than 10 patients having a lower extremity venous~     ulcer(s), less than 5cm diameter and with an estimated one month time of re-epithelization.~     In this study the investigators will follow and monitor the healing of the wound and~     effectiveness of compression therapy using bioimpedance measurement based method. The~     investigators will also treat the wounds using periodical low intensity direct current (LIDC)~     stimulation therapy.~      Bioimpedance monitoring and wound stimulation functionalities are provided by a purpose built~     wound patch. The patch features a printed 4 x 4 stimulation and impedance measurement~     electrodes array (in contact with wound surface) surrounded by a 4-part dual purpose counter~     and impedance reference electrodes (in contact with the intact skin surrounding the wound~     area).~   "
111986|NCT02101632|"~     Topical application of BV ointment in patients with Research Diagnostic~     Criteria/Temporomandibular Disorder 1a and 1b (RDC/TMD) in experimental group, compared to~     placebo (vaseline) in control group.Application was repeated 3 times a day, during 14 days.~     Surface electromyography (EMG) was used to measure masseter rest tonus and maximal voluntary~     contraction tonus. Pain intensity was also analysed in VAS scale. Effectiveness of BV was~     compared with placebo in masseter myofascial pain in patients with TMD~   "
111987|NCT02101619|"~     Aortic stenosis (AS) is the most common valve disease in the United States and most common~     indication for valve replacement surgery. Anatomical and hemodynamic severity of AS is~     insufficient for elucidating patients' prognosis. Therefore, the decision about the optimal~     timing of surgical intervention remains critical. However, the changes in structure and~     electrical activity of the cardiac muscle can be assessed by noninvasive imaging and~     electrocardiography (ECG). Degenerative myocardial changes characterized by fibrosis or~     collagen deposits are frequently observed in AS patients and have a negative impact on~     patient outcomes. In this project, our objective is to determine whether echocardiographic~     image analysis of integrated backscatter (IB), which can express changes in myocardial tissue~     composition (amount of fibrosis) based on its ultrasound reflectivity, global left~     ventricular (LV) load as measured by Zva, and ECG analysis of the duration of the QRS~     interval have a role in risk stratification for AS patients and to apply those methods to~     identify which patients would benefit from surgical intervention.~      The investigators hypothesize that 1) the severity of myocardial damage can discriminate the~     prognosis in patients with AS, and 2) IB, Zva, and QRS interval can be diagnostic measures of~     the severity of myocardial damage. The investigators will measure the severity of myocardial~     fibrosis using MRI (reference) in 50 patients and will test the diagnostic significance of IB~     (testing method). Zva, QRS duration, and conventional echocardiographic measures will also be~     tested for diagnosing severity of myocardial fibrosis.~   "
111988|NCT02101606|"~     Rationale The only proven therapy for acute stroke is tPA within 4.5 hours of symptom onset.~     This is the standard of care for patients presenting to our hospital within that time frame.~     Thrombolysis outside the 4.5 hour window is considered only on experimental or compassionate~     grounds. Tenecteplase (TNK) is a genetically modified variant of tPA that has many~     theoretical advantages in acute stroke. Studies show that systemic plasminogen activation is~     higher after tPA administration, relative to TNK and this is associated with an increased~     risk of bleeding events. Imaging cerebral blood flow (CBF) with MRI (perfusion weighted~     imaging-PWI) and CT perfusion (CTP) can be performed routinely with standard clinical~     scanners. Patients with evidence of large volumes of tissue with low CBF, that is also~     structurally intact, as demonstrated by either normal signal on Diffusion weighted imaging~     (DWI) or normal cerebral blood volume (CBV) are considered to have penumbral patterns.~     Patients with penumbral patterns appear to be the ideal candidates for thrombolytic therapy,~     regardless of time from onset.~      Study Hypotheses~        1. The primary aim of this study is to demonstrate the feasibility and safety of TNK based~          thrombolysis in ischemic stroke patients presenting 4.5-24 hours after symptom onset.~        2. It is hypothesized that treatment with TNK in patients with penumbral patterns will be~          associated with reperfusion, early neurological improvement and penumbral tissue~          salvage.~      Study Design The study is planned as an open label feasibility and safety study of acute~     treatment with TNK in ischemic stroke patients with penumbral patterns evident on advanced~     MRI or CT perfusion sequences.~      Study Outcomes The primary outcome of this study is a safety endpoint, specifically the~     frequency of symptomatic hemorrhagic transformation evident on MRI or CT images on 24 h or~     day 5 scans. The ECASS II system for rating hemorrhagic transformation will be applied to all~     GRE/SWI images~      Significance Current treatment paradigms have not permitted success of tPA to be extended~     beyond narrow and limiting therapeutic window of 4.5 hours. Clearly, more effective patient~     selection criteria are required. Penumbral imaging is biologically plausible, practical and~     has been shown to be predictive of outcome. Application of these imaging techniques to the~     acute stroke population is the most promising strategy for extending the therapeutic window~     and for introducing superior thrombolytic agents.~   "
111989|NCT02101593|"~     Assessment of safety and tolerability of ADI-PEG 20 in combination with sorafenib in advanced~     Hepatocellular Carcinoma (HCC).~   "
111990|NCT02101580|"~     Assessment of safety and tolerability of ADI-PEG 20 plus nab-Paclitaxel and Gemcitabine in~     subjects with Advanced Pancreatic Carcinoma.~   "
111991|NCT02101567|"~     The investigators compare the effectiveness and adverse effects of I.V carbetocin versus~     oxytocin & ergometrine I.V for prevention of postpartum haemorrhage following cesarean~     section.~   "
111992|NCT02101554|"~     Safety and pharmacokinetics of an abuse-deterrent, extended-release formulation of morphine~     sulfate with a sequestered naltrexone core in children 7-17 with moderate-severe pain.~   "
111993|NCT02101541|"~     The FIRM Study Oslo will in two sequential within-patient trials investigate the efficacy of~     focal impulse and rotor modulation (FIRM) as a stand-alone procedure in the treatment of~     paroxysmal and persistent atrial fibrillation, evaluated by continuous pre- and~     post-procedural heart rhythm monitoring.~   "
111994|NCT02101528|"~     Decreased muscle strength has been reported to be a factor contributing to increased~     incidences of falling in the elderly patients causing fractures, joint dislocations, severe~     soft tissue lesions and head trauma. Parkinson's Disease (PD) patients often complain of~     weakness and it has been reported that they have reduced muscle strength, decreased rate of~     force development, impaired ability to maintain constant force, and increased muscle~     coactivation during balance perturbation tasks. The specific cause of this weakness is not~     known, and in this study the investigators have analyzed and measured isokinetic muscle~     strength in PD patients to clarify this issue. The investigators have compared the data~     obtained with those of age-matched controls.~   "
111995|NCT02101515|"~     The hypothesis of this study is that extending the second stage of labor beyond current ACOG~     suggestions can reduce the cesarean delivery rate. The cesarean delivery rate in the United~     States is around 30 percent. This is a number that continues to be increasing over the last~     few decades and will continue to climb. Each subsequent cesarean section puts the mother and~     baby at increased risk for postpartum hemorrhage, bowel and bladder injury, abnormal~     placentation, febrile morbidity and death. The most common reason for a cesarean delivery is~     a repeat cesarean delivery. One way to reduce this number is to prevent the first cesarean~     delivery. The aim of this study is evaluate if extending the second stage of labor affects~     the cesarean delivery rate and subsequent perinatal morbidity.~   "
111996|NCT02101502|"~     This work aimed to prepare the obstetrics and gynecology department for high education and~     health care accreditation.~   "
111997|NCT02101489|"~     This purpose of this study is to study is to see if intra-operative urethral length~     measurement with the Foley catheter will improve the placement of a synthetic sling in the~     mid-urethra.~   "
111998|NCT02101476|"~     The purpose of this study is to compare the analgesic efficacy of Xartemis 15mg/650mg by~     mouth every 12 hours for the management of acute moderate to severe post operative pain to~     generic Oxycodone/APAP(acetaminophen) (Percocet) 10mg/650mg by mouth every 6 hours.~   "
111999|NCT02101463|"~     This trial evaluates surgeon-modified fenestrated-branched stent-grafts (sm-FBSG) for~     Abdominal Aortic Aneurysms (AAA) that are custom-made intra-operatively with no waiting~     period by a qualified vascular surgeon. In addition, it aims to examine the alternative~     sm-FBSG for patients with restricted access to centers performing clinical trials with~     commercially available devices and those patients with aortic emergencies.~   "
112000|NCT02101450|"~     During cesarean section, it is important to provide hemostasis as well as to decrease the~     amount of hemorrhagic fluid and fibrin in the abdominal cavity. Hemorrhagic fluid and fibrin~     together may cause adhesion formation and therefore postoperative ileus, retardation in~     regaining the gastrointestinal functions as well as prolongation of the operation itself.~     Dragging the uterus out of the abdominal cavity during cesarean section before removing the~     placenta (extra-abdominal removal of the placenta) may decrease the amount of blood flowing~     into the abdominal cavity during removal of placenta. In this study the investigators aimed~     to evaluate the influence of intra abdominal vs extra abdominal removal of placenta on~     duration of operation, the amount of aspirated fluid during the operation, difference between~     postoperative hemoglobin and hematocrit levels, postoperative pain score, additional need of~     analgesia, postoperative bowel movements, postoperative endometritis and wound infection.~   "
112027|NCT02101099|"~     The aim of the study is to determine if more force is used during colonoscopy when patients~     receive monitored anesthesia with propofol versus conscious sedation. Force measurements will~     be performed using the colonoscopy force monitor (CFM). This device measures the magnitude~     and direction of force applied to the insertion tube of a standard colonoscope during~     colonoscopy.~   "
112028|NCT02101086|"~     The purpose of this study is to investigate the efficacy and safety of autologous cord blood~     transfusions in very-low-birth-weight premature infants, and to evaluate the developmental~     outcomes of the infants who received autologous transfusions.~   "
114182|NCT02072915|"~     To compare the number of passes required for cellblock acquisition with and without suction~     using the 25g needle.~   "
112001|NCT02101437|"~     For acute coronary syndrome patients undergoing cardiac catheterization after stenting, we~     will give dual antiplatelet drugs (dual antiplatelet agents) therapy, the choice of the basis~     of medical criteria (clinical guidelines) routine as aspirin + clopidogrel or aspirin +~     ticagrelor, according to medical guidelines currently no other disposal alternative proposal~     (unless adverse drug tolerance or bleeding can not be administered); idea of this experiment~     for acute coronary syndrome or conventional cardiac catheterization after stenting, platelet~     miRNA expression (miR-96 , miR-200b, miR-495, miR-107) after cardiac catheterization and~     interventional treatment of clopidogrel or ticagrelor acceptance of platelet reactivity (PRU)~     correlation values (given clopidogrel or ticagrelor determined by the clinician, the patient~     follow-up experiment to track only and observation), aims to explore under different platelet~     reactivity (hyper-reactive or hypo-reactive), their differences in miRNA performance.~   "
112002|NCT02101424|"~     This study will compare the data from pulse oximeters to capnographers as they are used to~     monitor patients who are being observed in the Emergency Department for a suspected overdose~     of alcohol or other drugs. The investigators will compare monitor data from patients who are~     and are not on supplemental oxygen, the ability of the monitors to predict the occurrence of~     airway interventions, and to detect ventilator changes noted on the opposing monitor. There~     will not be any interventions during this study other than the collection of data from the~     monitors and observation of the care of patients.~   "
112003|NCT02101411|"~     Since thrombus formation is a very complex procedure in vivo, platelet function testing~     methods in vitro might only reflect the degree of inhibition of platelet from a certain~     level, which do't reflect the functional status of platelets in vivo adequately. There are a~     variety of signal transduction pathways involved in the formation of platelet activation and~     thrombosis. Gurbel et al. first reported individuals with variability on clopidogrel~     treatment response in 2003, and proposed the concept of clopidogrel resistance. Different~     patients received the same dose of aspirin or other anti -platelet drug such as clopidogrel ,~     due to various reasons bound to lack some patients antithrombotic efforts to increase the~     incidence of thrombotic events , while another part of the patient easily understood~     antithrombotic excessive bleeding events,  antithrombotic individualized treatment , ~     according to differences in patient against platelet drugs or anticoagulant drug reactions~     and adjust the treatment plan , is the direction of antithrombotic therapy in the future.~      There are a number of studies have shown that patients with no response Clopidogrel ,~     measuring the relationship between high platelet reactivity and clinical adverse ischemic~     events displayed between platelet activity . However, there is still lack of quantitative~     threshold high platelet reactivity and the risks associated with the clinical consensus . In~     addition, there are only limited data support, to measure platelet function -based therapy to~     improve the clinical efficacy of the concept . Over the years, more than 20,000 cases~     reported in patients with numerous studies confirm that high platelet reactivity after PCI~     with stent thrombosis , including cardiovascular events , including an increased risk of~     significant correlation . Pharmacodynamic analysis GRVITAS trial showed significantly lower~     platelet reactivity associated with a lower risk of adverse cardiovascular events . Brar in~     more than 3000 cases of patients published in JACC Meta-analysis showed that high platelet~     reactivity  of patients whose cardiovascular death, heart attack and stent thrombosis~     occurred more than twice the rate of  non-high platelet reactivity  patients .~      Two new anti-platelet drugs (Prasugrel and Ticagrelor) in several recent randomized trials~     have considerable persuasive , and has included some guidance in the current guidelines.~     Ticagrelor even more than Prasugrel in pharmacodynamic studies more effectively inhibit~     platelet , and has a lower risk of bleeding. Cilostazol is an old drug , mostly for the~     treatment of intermittent claudication , in recent years there are also some testing and~     coronary stents prevent restenosis after angioplasty , however, so far , there is little~     direct comparison Cilostazol and Ticagrelor related articles .~      We designed this test , in addition to testing for high yellow people treat DAPT (dual~     anti-platelet therapy) under the platelet reactivity (high on-treatment platelet reactivity)~     ratio , this population of patients with ticagrelor instead for a month or cilostazol~     treatment after its platelet reactivity changes and compare between the two groups , and even~     track six months after the bleeding and adverse cardiovascular events rate? Through this test~     we can compare the treatment for patients with high platelet reactivity of what strategies~     more appropriate.~   "
112004|NCT02101398|"~     The aim of this work is to study the effect of transcranial direct current stimulation~     combined with naming therapy in acute and post-acute stroke comparing four bihemispheric~     positioning electrodes to a sham condition.~   "
112005|NCT02101385|"~     This study will test the theory that therapy designed for each individual's tumor will~     improve outcomes over standard of care in a population that needs a better standard.~   "
112006|NCT02101372|"~     The AGES-CM consortium aims to study the interaction between the polymorphisms of the~     candidate genes related with neurodevelopment, neurotransmission, brain progressive changes,~     cognitive functioning and stressful life events (prospective- and retrospectively assessed)~     and the association of the interactions with structural and functional brain measures,~     neuropsychological performance, biochemical and oxidative status in both in patients and~     controls. The investigators study aimed to examine the effectiveness of a parallel,~     structured, and specific psychoeducational group intervention (PE) for adolescent patients~     and their families by comparing it with treatment as usual).~   "
112007|NCT02101359|"~     The purpose of this study is to determine the efficacy and safety assessment of T2380 for~     mydriasis and anaesthesia in phacoemulsification cataract surgery versus reference group~     (topical mydriatics and anaesthetic) 2X246 patients.~   "
112008|NCT02101346|"~     The aim of the present study is to identify the effects of different dietary fats on the~     body's immune system and how different types of cells respond. There will be two rounds of~     recruitment in order to satisfy different aims of the study. In the first round, volunteers~     will be asked to undergo five separate 1-day assessments where you will be given diets in the~     form of milkshakes differing in amounts of fats. Volunteers recruited for this round will~     also be given the opportunity to participate in the second round of recruitment and feeding.~     A second round of recruitment will then take place to complete recruitment, if required. In~     the second round, volunteers will be asked to undergo two separate 1-day assessments in the~     form of milkshakes with differing fats, one of which will contain a tracking label added to~     the food during preparation. This label is in the form of is a 'stable isotope' and safe to~     consume (used commonly in some medical tests - see below for further information) and will~     allow the researchers to later find the food particles within blood cells. During these 1-day~     assessments blood samples will be collected to identify the impact different diets have on~     the immune system, specifically monocyte cells thought to play an important role in the~     development of atherosclerosis, a primary cause of cardiovascular disease.~   "
112009|NCT02101333|"~     First-line tocilizumab treatment during 6 months could permit rapid steroid-tapering and~     induction of remission in Takayasu arteritis (TA).~   "
112010|NCT02101320|"~     In France, breast cancer affects approximately 53,000 new cases per year. The investigators~     have to take care more and more women with subclinical lesions (nonpalpable), and it~     represents around 25% to 35% of the diagnosed breast cancers. The main problem of the~     surgical management of these lesions is the quality of preoperative identification which~     determines the quality of surgery and oncological and cosmetic outcomes. For this type of~     lesion, SNOLL (Sentinel Node and Occult Lesion Localization) procedure could be proposed.~     This is a radioactive labeling of the tumor site and sentinel lymph node (SLN). The~     investigators want to evaluate the potential benefits of using a hand held camera called~     TreCam in this SNOLL procedure. This camera permits to obtain nuclear imaging at the bedside~     and in the operating theater.~   "
112011|NCT02101307|"~     This non-interventional study will observe the usage and efficacy of RoActemra/Actemra in~     patients with rheumatoid arthritis (RA) who have recently begun treatment. The treatment~     regimen will be directed by the treating physician according to clinical practice. Patients~     are expected to be observed for approximately 6 months after beginning treatment.~   "
112024|NCT02101138|"~     Background:~      - Eosinophils are white blood cells that fight infections. In people with hypereosinophilic~     syndrome (HES), eosinophil levels are too high and can damage their organs. HES is usually~     treated with steroids, but steroids can cause side effects and stop working over time.~     Researchers want to see if a drug called dexpramipexole, being developed by Knopp~     Pharmaceuticals, can help people with HES to reduce their steroid dose.~      Objective:~      - To test whether dexpramipexole can reduce the steroid dose needed to control eosinophilia~     and HES symptoms.~      Eligibility:~      - Adults 18 and older with HES who respond to steroids, but need more than 10 mg daily to~     control eosinophilia and symptoms.~      Design:~        -  The study will last 9 months with 6 visits to NIH.~        -  Participants will be screened with medical history, physical exam, and urine and blood~          samples.~        -  Participants steroids will be tapered to the lowest effective dose. During this time,~          blood will be drawn weekly. Participants will take this dose for 2 weeks before starting~          the study drug.~        -  Participants will take the study drug twice daily by mouth for 12 weeks along with~          steroids. The steroid dose will not be decreased during this time and participants will~          be seen monthly for a medical history, physical examination and blood work.~        -  Just before and 12 weeks after starting the study drug, the following tests will be~          performed:~        -  medical history and physical exam~        -  blood and urine tests~        -  lung function tests~        -  electrocardiogram (measures heart electrical activity)~        -  echocardiogram (takes pictures of the heart using sound waves)~        -  bone marrow biopsy (a needle inserted into the hip bone that removes bone marrow cells~          for study)~        -  After 12 weeks, the participants steroid dose will be tapered again to the lowest~          effective dose while on study drug.~        -  Two weeks after the lowest effective dose is reached, participants will return for a~          medical history, physical examination, blood work, lung and heart tests.~        -  Participants who respond to the study drug may be able to continue to receive the drug~          on a planned separate study.~        -  Four weeks after stopping the study drug, participants will have medical history,~          physical exam, and blood tests.~   "
112012|NCT02101294|"~     The study hypothesis is that there is a relationship between the keyboard layout and carpal~     tunnel syndrome (CTS). Specifically, use of the standard QWERTY keyboard increases the risk~     of symptoms of carpal tunnel syndrome. The QWERTY keyboard requires more effort by the~     fingers than necessary to perform the required work, i.e. data or word entry; up to 200~     percent more flexion and extension and 100 percent more distance traveled.~      The purpose of the protocol is to evaluate two keyboard layouts for carpal tunnel syndrome~     therapy, and to see if the efficient keyboard, Finger Relief, can be used as an adjunctive~     tool to other treatments or therapy for CTS for typists. Subjects who had received a~     diagnosis of carpal tunnel syndrome from their medical doctor and, where not contraindicated,~     had received confirmation of the diagnosis of carpal tunnel syndrome with a nerve conduction~     velocity (NCV) study participated in four typing sessions to compare onset and severity of~     carpal tunnel symptoms. Testing sessions alternated between keyboards. The keyboard selected~     for the first typing session was determined by random assignment. Twenty subjects completed~     all four typing sessions. The test protocol consisted of a medical history, 3 tests of the~     subjective pain experience of the subject (visual analogue scale / verbal rating scale, and~     hand diagram), 2 clinical measures of physical manifestations of swelling associated with~     carpal tunnel syndrome (water volume/tape measure), and a measure of the length of time spent~     typing on each keyboard layout - QWERTY and TheOrdinals (the Finger Relief keyboard).~   "
112013|NCT02101281|"~     The purpose of the study is to assess the efficacy and safety of different doses of rhNGF~     when administered as eye drops to patients with Dry Eye.~   "
112014|NCT02101268|"~     This study is to determine the efficacy of momelotinib (MMB) versus best available therapy~     (BAT) in anemic or thrombocytopenic adults with primary myelofibrosis (PMF), or~     post-polycythemia vera or post-essential thrombocythemia myelofibrosis (Post-PV/ET MF) who~     were treated with ruxolitinib as measured by splenic response rate at Week 24 (SRR24).~      Participants will be randomized to receive either MMB or BAT for 24 weeks during the~     randomized treatment phase, after which they will be eligible to receive MMB in an extended~     treatment phase for up to an additional 204 weeks. After discontinuation of study medication,~     assessments will continue for 12 additional weeks, after which participants will be contacted~     for survival follow-up approximately every 6 months for up to 5 years from the date of~     enrollment or until study termination. For those subjects planning to continue treatment with~     MMB following the end of the study, the End of Treatment, 30-day, 12-Week, and survival~     follow-up visits are not required.~   "
112015|NCT02101255|"~     The purpose of this study is to evaluate the therapeutic benefit of Curodont Repair for the~     treatment of early approximal carious lesions compared to fluoride.~   "
112016|NCT02101242|"~     A total of 60 patients will be enrolled in the study: 20 each who receive surgery in beach~     chair position or Trendelenburg's position and 20 patients undergoing cardiac surgery.~     Regional cerebral oxygen saturation will be measured continuously during surgery. Duration~     and extent of deviations from individual baseline values will be recorded and detected~     deviations treated according to their clinically apparent cause (e.g.~     hypotension/hypovolaemia, anaemia, low cardiac output) in accordance with our standard~     operating procedures (SOPs).~      Patients are then followed up until the end of hospital stay or for a maximum of 10 days~     after surgery. Their level of cognitive function will be tested and compared to the data~     acquired before surgery to detect impairment, delirium or postoperative cognitive deficit~     (POCD).~      The purpose of this pilot study is to evaluate the design and conduct of a projected full~     scale observational clinical study.~   "
112017|NCT02101229|"~     To assess whether the DIABELOOP algorithm provides better glycemic control than the usual~     algorithm of T1D patients on pump therapy:~        -  at meals, with CHO roughly assessed by the patient.~        -  during and after physical activity sessions qualified as moderate by the patient.~      Primary endpoint : time within the glycemic reference range. The study will be conduct with~     15 patients at the following investigation centers : Corbeil Hospital, CHU of Grenoble, and~     CHU of Montpellier.~   "
112018|NCT02101216|"~     Cellceutix Corporation has created a new chemical entity for the treatment of psoriasis,~     termed Prurisol™, which is an ester of abacavir. This first-in-human study of Prurisol~     (abacavir acetate) is being performed to evaluate the pharmacokinetics, safety and tolerance~     of a single oral doses of Prurisol administered to healthy volunteers and the bioequivalence~     to abacavir sulfate (Ziagen). This study will be followed by a 505(b)(2) Phase 2 trial in~     patients with moderate to severe plaque psoriasis.~   "
112019|NCT02101203|"~     A double-blind, randomized, placebo-controlled, dose-finding study to investigate the safety~     and efficacy of Lybridos in the domestic setting in healthy female subjects with hypoactive~     sexual desire disorder and maladaptive activity of sexual inhibitory mechanisms.~      This is a 2-arm placebo and Lybridos (0.5 mg testosterone + buspirone 10 mg) extension to~     study EB90 (Clinical Study Protocol EB90a, version 3.0, 07 June 2013).~      In the present study, the efficacy of Lybridos will be evaluated in the domestic setting in~     healthy female subjects with HSDD and maladaptive activity of sexual inhibitory mechanism(s).~     Sexual satisfaction and other aspects of sexual functioning will be measured within 24 hours~     after each sexual activity. The following hypotheses will be tested:~      Lybridos, as compared to placebo, will significantly increase the number of satisfying sexual~     events.~      Objectives:~      To investigate the efficacy of Lybridos as compared to placebo in increasing the number of~     satisfactory sexual episodes in healthy female subjects with hypoactive sexual desire~     disorder (HSDD) and maladaptive activity of sexual inhibitory mechanisms~        -  To identify the optimal dose of Lybridos to take into phase 3 clinical development~        -  To confirm that Lybridos has superior efficacy as compared to testosterone alone and to~          buspirone alone~        -  To evaluate the effect of Lybridos as measured by scales of sexual satisfaction and/or~          sexual desire/arousal~        -  To evaluate the safety profile of Lybridos~   "
112020|NCT02101190|"~     The purpose of this study is to assess the pharmacokinetics (PK) of BIA 9-1067 in patients~     with moderate chronic hepatic impairment and in matched healthy subjects.~   "
112021|NCT02101177|"~     The aim of the study is to analyse data coming from two treatment centres of the National~     Treatment Program Centres of hepatitis C in Egypt~   "
112022|NCT02101164|"~     This study will estimate the total time for the preparation and administration of denosumab~     and the total time for the preparation and administration of pamidronate.~   "
112029|NCT02101073|"~     The overall aims of the study are:~        -  To assess the bioavailability of single doses of ALX-0061, administered s.c. at three~          dose levels, using 2 corresponding single i.v. dose levels as reference.~        -  To provide additional information on pharmacokinetics and pharmacodynamics of ALX-0061.~        -  To further determine the safety and tolerability of ALX-0061.~        -  To further evaluate the systemic (serum) immunogenicity of ALX-0061.~   "
112030|NCT02101060|"~     Research is needed to determine safe and effective exercise rehabilitation programs to~     prevent and improve physical disability in older adults living with HIV. This problem is of~     great importance to the VA. The majority of the 25 thousand HIV-infected veterans are over 50~     years of age (64%). The combined effect of aging and inflammation increase the risk for~     physical disability in older HIV-infected veterans. This translational exercise training~     trial will examine the cardiac and skeletal muscle effects of combined aerobic exercise and~     resistance training to attenuate the functional declines of aging with HIV by reducing the~     deleterious consequences of chronic inflammation. Findings will guide future rehabilitation~     research on cardiac remodeling and inflammation of skeletal muscle. The proposed research~     will advance the goal to develop effective rehabilitation strategies that improve the health~     of older HIV-infected veterans.~   "
112031|NCT02101047|"~     Three different regimens of phenylephrine are being evaluated to see if one is superior over~     the other in the maintenance of cardiac output while keeping normotension and/or treating~     hypotension experienced when receiving spinal anesthesia for cesarean delivery.~   "
112032|NCT02101034|"~     The purpose of this Phase I/II study is to define the maximum tolerated dose of PD 0332991~     given with cetuximab and evaluated the side effects of the combination.~   "
112033|NCT02101021|"~     There will be two phases to this study. The lead-in phase will evaluate the safety,~     pharmacokinetics, and define the maximum tolerated dose (MTD) of momelotinib (MMB) combined~     with nab-paclitaxel and gemcitabine (nab-P + G) in adults with previously untreated~     metastatic pancreatic ductal adenocarcinoma. The randomized treatment phase will evaluate the~     efficacy, safety, and tolerability of nab-P + G with either MMB administered at the MTD or~     placebo in adults with previously untreated metastatic pancreatic ductal adenocarcinoma.~     Participants will continue study treatment until disease progression, unacceptable toxicity,~     consent withdrawal, or participant's refusal of treatment. Following treatment, participants~     will be followed for safety for 30 days and for survival approximately every 3 months for up~     to 3 years.~   "
112034|NCT02101008|"~     Primary Objectives Determine the response rate associated with treatment of refractory~     disseminated malignant melanoma with disulfiram and chelated zinc.~      Secondary Objectives Determine the progression-free survival associated with treatment of~     refractory disseminated malignant melanoma with disulfiram and chelated zinc.~      Determine the overall survival associated with treatment of refractory disseminated malignant~     melanoma with disulfiram and chelated zinc.~      Determine the toxicity associated with treatment of refractory disseminated malignant~     melanoma with disulfiram and chelated zinc Determine the effect of disulfiram and chelated~     zinc on in vivo protein S-glutathionylation.~   "
112035|NCT02100995|"~     The purpose of this study is to determine whether an integrated behavioral treatment approach~     can help overweight or obese individuals who also have chronic pain reduce their weight and~     manage their pain symptoms. The goal of this research is to develop better treatments for~     individuals with chronic pain and overweight or obesity. All participants in this study will~     receive treatment for weight management and/or pain symptoms. Participants will be assigned~     at random (like we picked it blindly out of a hat) to receive either: (1) Standard behavioral~     treatment for weight loss; or (2) Standard behavioral treatment for pain management; or (3)~     Integrated behavioral treatment for weight loss and pain.~   "
112036|NCT02100982|"~     The goal of this study is to develop and test Customized Care, an intervention to help~     patients dealing with depression and/or anxiety in the context of multiple chronic~     conditions. Customized Care is designed to help patients communicate about important issues,~     such as financial and safety concerns, with their primary care providers (PCPs). The~     intervention will be delivered in patient waiting rooms prior to a routine follow-up visit~     with the PCP. Phase 1 of the project will ensure that the main components of Customized Care~     are acceptable to patients and PCPs. Phase 2 will include a pilot study to test the effects~     of Customized Care on patient-PCP communication.~      Participants aged 40 years or older who have a diagnosis of two or more common chronic~     medical conditions will be recruited from primary care clinics. Patients screening positive~     for either depression or anxiety will be randomized to Customized Care vs. an active control.~      The investigators hypothesize that the Customized Care will improve patient-Primary~     Care-Provider communication.~   "
112037|NCT02100969|"~     The purpose of this study is to determine whether Hizentra is a safe and effective treatment~     for people with myasthenia gravis (MG).~   "
112038|NCT02100956|"~     The purpose of the study is to determine the effect of oxytocin given into the spinal fluid~     on pain and areas and intensity of hyperalgesia and allodynia in patients with chronic~     neuropathic pain.~   "
112039|NCT02100943|"~     This study will evaluate the presence or absence of Obstructive Sleep Apnea (OSA) in the~     third trimester of pregnancy and again postpartum.~   "
112040|NCT02100930|"~     The purpose of this study is to be able to supply an experimental combination of drugs called~     3F8 and GM-CSF (also called sargramostim) to patients with high-risk neuroblastoma who may~     benefit from treatment.~   "
112041|NCT02100917|"~     This study is a randomized Trastuzumab-controlled double-blind parallel-group study.~   "
112055|NCT02100735|"~     The purpose of this study is to evaluate how the investigators provide sedation (medicine~     that make you sleepy) in the investigators intensive care unit (ICU). This study will look at~     a new way of using sedation in the ICU to see what effect it has on patients and if it~     decreases the amount of time spent on mechanical ventilation (machine that breathes for you),~     and in the ICU.~   "
112056|NCT02100722|"~     The purpose of this study is to determine whether Fractional flow reserve (FFR, (coronary~     pressure wire-based index for assessing the ischemic potential of a coronary lesion)-guided~     percutaneous coronary intervention (PCI) in patients with multivessel coronary artery disease~     (CAD) will result in similar outcomes to coronary artery bypass graft surgery (CABG).~   "
112042|NCT02100904|"~     The ULTRA Registry is a nationwide observational arm of the ULTRA trial. Data from the ULTRA~     Registry will be used to evaluate the long-term safety and efficacy of laparoscopic RF~     ablation (Acessa).~      The ULTRA Registry will recruit women age 21 or older who plan to undergo or have undergone~     laparoscopic RF ablation (Acessa) within the United States. Participants will be recruited~     through study materials distributed at clinical offices across the country where~     gynecologists are performing laparoscopic RF ablation (Acessa). Study participants will~     consent to participate in a 3 year prospective study conducted by UCSF but the laparoscopic~     RF ablation (Acessa) surgery will be performed by the study participants' own gynecologist.~     We will evaluate changes in fibroid-related symptoms from pre-treatment values to 6, 12, 18,~     24, 30, and 36 months after RFA (Acessa). We will determine long-term efficacy of RFA~     (Acessa) by evaluating the rate of re-treatment for symptomatic fibroids after the RFA~     (Acessa) procedure. Participants will be asked for permission to review their medical records~     to assess surgical and pregnancy outcomes. The gynecologists performing the laparoscopic RF~     ablation (Acessa) surgery will be asked to consent to complete a brief study questionnaire~     with information on demographics, work history, professional training, and practice setting.~      UC San Francisco will have oversight of all scientific and administrative aspects of the~     study. All study data will be stored securely in a HIPAA compliant, secure database monitored~     by the UC San Francisco Coordinating Center.~   "
112043|NCT02100891|"~     The investigators hypothesize that this Phase 2 cellular and adoptive immunotherapy study~     using human leukocyte antigen (HLA)-haploidentical hematopoietic cell transplantation (HCT)~     followed by an early, post-transplant infusion of donor natural killer (NK) cells on Day +7~     will not only be well-tolerated in this heavily-treated population (safety), but will also~     provide a mechanism to treat high-risk solid tumors, leading to improved disease control rate~     (efficacy). Disease control rate is defined as the combination of complete (CR) and partial~     (PR) response and stable disease (SD). The investigators further propose that this infusion~     of donor NK cells will influence the development of particular NK and T cell subtypes which~     will provide immediate/long-term tumor surveillance, infectious monitoring, and durable~     engraftment.~      Patients with high-risk solid tumors (Ewings Sarcoma, Neuroblastoma and Rhabdomyosarcoma) who~     have either measurable or unmeasurable disease and have met eligibility will be enrolled on~     this trial for a goal enrollment of 20 patients over 4 years.~   "
112044|NCT02100878|"~     Physical exercise has been shown to significantly reduce subsequent energy intake in obese~     adolescents but not in lean, without altering their appetite feelings. Although previous~     studies have pointed out the role of gastric peptides in this post exercise nutritional~     response, some recent work question the role of the neural system in the post exercise drive~     to eat. This study tends to explore whether or not an acute bout of exercise can affect the~     neural response to food cues in adolescents, obese or lean.~   "
112045|NCT02100865|"~     Globally, approximately 2.1 million children die of pneumonia each year. Most deaths occur in~     resource-poor settings in Africa and Asia. Oxygen (O2) therapy is essential to support life~     in these patients. Large gaps remain in the case management of children presenting to African~     hospitals with respiratory distress, including essential supportive therapies such as~     supplemental oxygen. We hypothesize that a novel strategy for oxygen delivery, solar-powered~     oxygen, can be implemented in remote locations and will be non-inferior to standard oxygen~     delivery by compressed gas cylinders.~   "
112046|NCT02100852|"~     The purpose of this study is to evaluate the safety and effectiveness of TGR-1202 in~     combination with obinutuzumab (Gazyva) and chlorambucil in patients with chronic lymphocytic~     leukemia.~   "
112047|NCT02100839|"~     The purpose of the first part of this study is to determine the safety and tolerability of a~     single dose of AEM-28, an apolipoprotein E mimetic, in subjects with high total cholesterol~     who are otherwise healthy subjects. The pharmacokinetics and pharmacodynamics of AEM-28 will~     also be evaluated.~      The second part of this study will be a multiple ascending dose evaluation of AEM-28 in~     patients with refractory hypercholesterolemia.~      AEM-28 has demonstrated significant lipid lowering activity and positive effects on the~     artery wall. AEM-28 is being developed for the treatment of homozygous familial~     hypercholesterolemia.~   "
112048|NCT02100826|"~     The purpose of this study is to compare two different preparations of an antibiotic called~     cephalexin to determine if they are essentially the same. The study has two periods.~     Participants will receive one preparation of cephalexin in each period. At least 7 hours will~     pass between the study periods. The study is expected to last about 2 days for each~     participant, not including screening or follow-up.~   "
112049|NCT02100813|"~     To identify the Maximum Tolerated Dose levels of LEO 43204 after once daily treatment for two~     consecutive days and to evaluate efficacy of LEO 43204 in two doses after once daily~     treatment for two consecutive days compared to vehicle~   "
112050|NCT02100800|"~     Emphysema is a major pathological feature of Chronic Obstructive Pulmonary Disease (COPD).~     Non-invasive assessment of emphysema is a crucial issue for the phenotype and follow-up of~     COPD patients. Currently, CT is the method of reference to evaluate and quantify emphysema~     but it remains a radiation-based technique. Magnetic Resonance Imagery (MRI) with ultrashort~     echo time (UTE) pulse sequences is a promising non-ionizing alternative for lung imaging. Our~     objective is to evaluate emphysema in COPD patients using CT and MR-UTE, and to test the~     agreement between both techniques.~   "
112051|NCT02100787|"~     The objective of the study is to see if there is a change in tear osmolarity over time when~     moderate to severe dry eye subjects are treated with TheraTears® lubricating drops.~   "
112052|NCT02100774|"~     The aim was to identify minor genetic variations (single nucleotide polymorphisms) that~     explain the interindividual variability in bioavailability of fat soluble micronutrients (fat~     soluble vitamins and carotenoids).~   "
112053|NCT02100761|"~     To investigate the relationship between cytochrome P450 (CYP) 2C19 genetic polymorphism and~     the steady-state blood concentration of voriconazole in Chinese patients with invasive~     pulmonary aspergillosis (IPA), and to assess the effects of voriconazole trough concentration~     on the prognosis of IPA patients.~   "
112054|NCT02100748|"~     The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with~     placebo in patients with acute postoperative pain after bunionectomy.~   "
112057|NCT02100709|"~     This trial hopes to demonstrate the effect of 4 weeks of outpatient exercise rehabilitation~     on COPD patients. In particular the effect on:~        -  the amount of daily physical activity~        -  Quality of life~        -  The 6-minute walk distance~        -  Time to exacerbation~      and compare it to the effect of 4 weeks of outpatients rehabilitation with Noninvasive~     Ventilation as an adjunct therapy.~   "
112058|NCT02100696|"~     This phase III, double blind, placebo-controlled, multicenter study will investigate the~     efficacy and safety of etrolizumab during induction and maintenance of remission in~     participants with moderately to severely active ulcerative colitis (UC) who are refractory to~     or intolerant of TNF inhibitors.~   "
112059|NCT02100683|"~     The Nit-Occlud PDA Post-Approval Study is designed to continue to evaluate the safety and~     effectiveness of the device in the post-approval phase.~   "
112060|NCT02100670|"~     This Phase III pivotal efficacy study will assess efficacy and onset of pain relief of~     MFC51123 gel vs. placebo and MFC51123 gel vs. 1% diclofenac gel and 3% menthol gel in~     participants with an ankle sprain to support topical MFC51123 gel registration.~   "
112061|NCT02100657|"~     Study of Plitidepsin (Aplidin®) to determine the recommended dose (RD) of plitidepsin in~     Combination with Bortezomib and Dexamethasone in Patients with Relapsed and/or Refractory~     Multiple Myeloma.~   "
112062|NCT02100644|"~     The purpose of this study is to examine whether the VPA (Valproate) dose can be reduced by~     additional administration of LTG (Lamotrigine) in Japanese pre-menopausal female epilepsy~     patients aged 15 years or older, whose seizures are well controlled by VPA monotherapy.~   "
112063|NCT02100631|"~     Demonstrate that the vaccine offers protection based on antibody levels in older adults and~     is similar to antibody levels in adults aged 18-45 following vaccination with PXVX0200.~   "
112064|NCT02100618|"~     The purpose of this study is to establish the long-term persistence of the immune response~     and safety of the HPV vaccine in healthy females who were aged 9 to 25 years in the primary~     study (NCT00541970).~   "
112065|NCT02100605|"~     Phytosun decongestant nasal spray is a class I medical device registered in the European~     Union for the treatment of nasal congestion. The spray contains hypertonic seawater and~     essential oils. The objective of the study is to investigate the effects of a nasal spray,~     registered as a medical device under the name Phytosun Decongestant in the European Union, on~     speed of onset of relief of nasal congestion in 50 subjects suffering from nasal congestion~     associated with common cold.~   "
112066|NCT02100592|"~     Severe brain injuries induce alteration of state of consciousness. These functional~     limitations can be significantly alleviated by treatment neurorehabilitation, particularly if~     this is established early. It has been shown that treatment of vertical integration in~     patients in a vegetative state or minimally conscious state can improve the level of~     supervision and positive influence on rehabilitation. Therefore, there are sufficient~     indications that anticipate the treatment of vertical integration, since the phase of~     hospitalization in ICUs, may improve the functional outcome of the patient.~   "
112067|NCT02100579|"~     Total knee arthroplasty is associated with intense early postoperative pain. Fast track~     recovery programs including early therapy protocols and early hospital discharge are being~     implemented at various hospitals. The postoperative analgesic pain regimen should enhance~     functional recovery in addition to providing efficient analgesia with minimal side effects.~     Adductor canal blockade is commonly used to provide postoperative analgesia for total knee~     arthroplasty (TKA) surgery. The investigators hypothesize that an ultrasound guided adductor~     canal block will lower narcotic consumption and improved overall satisfaction compared to~     ultrasound guided sham block with normal saline (placebo) for patients undergoing minimally~     invasive TKA surgery.~   "
112068|NCT02100566|"~     People with life-limiting illness often receive more aggressive healthcare than desired~     including costly procedures that provide little medical benefit. Advance Directives (AD) can~     reduce this effect but various factors limit their adoption.~      A randomized trial will target hospitalized patients with a serious, life limiting illness to~     test if the behavioral economics principles of endowment (possessing something) and focusing~     (featuring something important to patients) can motivate AD completion. Investigators will~     examine if offering patients an AD by default, in combination with framing the rationale for~     AD completion (emphasizing patient control or caregiver burden) improves AD completion and~     family conversation compared to a no-intervention group. The study hypothesis is to determine~     if rates of AD completion and family conversations will be highest among patients receiving~     the intervention focused on reduced caregiver burden; and if the two intervention groups will~     have higher rates of both than the control group.~      The investigators suspect that a small change in how patient information is framed (endowment~     and focusing used in tandem) will potentially leverage large increases in AD completion and~     that targeting HHC patients allows AD discussions early in the disease trajectory when they~     can participate in care decisions.~   "
112069|NCT02100553|"~     This study will assess if itraconazole will affect the blood levels of Duavee when they are~     given together. This study will also assess if a subject's body size affects the blood levels~     of Duavee.~   "
112070|NCT02100540|"~     Hot flashes are the most common symptom of menopause and affect almost 75% of menopausal~     women. Clinical evidence indicates potent antagonists of 5-HT2A are more likely to cause~     hypothermia. Risperidone is a potent 5-HT2A and a dopamine D2 receptor antagonist and is~     proposed to have effect on reduciton of hot flashes through its dopaminergic and serotonergic~     antagonism. The primary purpose of this study is to determine if RCN3028 is effective and~     safe in the treatment of moderate to severe vasomotor symptoms associated. In accordance with~     the latest FDA guidance study participants will have a minimum of 7 moderate to sever hot~     flashes per day, or 50 per week at baseline.~   "
112071|NCT02100527|"~     This is a 6 week study to characterize the safety, tolerability and effects of PF-05175157~     administered for 6 weeks in subjects with moderate to severe acne vulgaris.~   "
112072|NCT02100514|"~     This study is a multicenter, double-blind, randomized study to access the efficacy, safety~     and tolerability of Bococizumab (PF-04950615; RN316) in subjects with hyperlipidemia~     receiving background statin therapy.~   "
112096|NCT02100202|"~     The purpose of this study is to investigate the efficacy and safety of dietary supplements~     (BioTurmin, BioTurmin-WD and MaQxan) on cotinine level and oxidative stress marker in chronic~     smokers having mild to moderate hyperlipidemia after 30 days of intervention.~   "
112073|NCT02100501|"~     The Ketogenic diet is a now proven, evidence based treatment of refractory epilepsy. the~     classic ketogenic diet (KD) is based on a ratio of fat to carbohydrate and protein, usually~     3:1 or 4:1. Fat is proven long-chain triglycerides. The efficacy of the KD has been proven by~     many multicenter trials. But, side effects of ketogenic diet therapy is severe. The modified~     atkins diet (MAD) was designed and investigated at Johns Hopkins Hospital, which aimed to~     propose a less restrictive dietary treatment that would be more palatable to children and~     adolescents with less side effects. The MAD consist of a nearly balance diet (60% fat, 30%~     protein, and 10% carbohydrates by weight), without any restriction on the recommended daily~     calories. Some literature suggested that the MAD is an effective treatment for refractory~     epilepsy. But, no randomised controlled study has been tried. the investigators aimed in this~     prospective study to evaluate the efficacy, safety and tolerability of MAD comparing to KD.~     The patients were recruited between age 3 to 18 years old with intractable epilepsy. Enrolled~     patients were randomly assigned to either one of two groups; the KD group and MAD group. The~     patients were required to attend outpatient clinic after 1, 3month to record their seizure~     frequency and severity, while their dietary treatment.~   "
112074|NCT02100488|"~     Achieving near-normoglycemia has been established as the main objective for most patients~     with diabetes. However, postprandial glucose control is a challenging issue in everyday~     diabetes care. Indeed, excessive postprandial glucose excursions are the major contributors~     to plasma glucose (PG) variability in subjects with type 1 diabetes (T1DM). In addition, the~     poor reproducibility of postprandial glucose response is burdensome for patients and~     healthcare professionals.~      Automatic glucose control, the so-called artificial pancreas or closed-loop system, may~     represent the ideal solution for reaching the therapeutic goals in diabetic patients.~     Intuitively, closed-loop insulin delivery may be superior to open-loop insulin delivery due~     to a better compensation of the variability of subcutaneous insulin absorption and the~     intra-subject insulin sensitivity. However, several challenges exist to effectively realize~     an optimal postprandial closed-loop control of blood glucose. Indeed, the eating process~     induces one of the major glucose perturbations that need to be controlled by an artificial~     pancreas and is currently one of the main challenges found in clinical validations of the few~     existing prototypes of an artificial pancreas. In particular, experiments carried out with~     the currently used algorithms for glucose control (the so called PID and MPC) showed that~     closed-loop insulin delivery often tend to overcorrect hyperglycemia thus increasing the risk~     hypoglycemia.~      In this project, a rigorous clinical testing of a novel closed-loop controller ('artificial~     pancreas') will be carried out in T1DM patients treated with continuous subcutaneous insulin~     infusion (CSII). The innovative element of the controller is a safety auxiliary feedback~     based on sliding mode reference conditioning (SMRC), which has been demonstrated (in~     simulation studies) to limit over-insulinization and the resulting hypoglycemia, reducing~     glycaemic variability.~      Standardized meal test studies will be performed in T1DM subjects treated with CSII,~     comparing the administration of a classical bolus (open-loop study) with a controller-driven~     prandial insulin delivery (closed-loop study) based on continuous subcutaneous glucose~     monitoring (CGM).~      The hypothesis is that closed loop control will provide better postprandial control,~     especially in terms of reduction of glucose variability and incidence of hypoglycemia.~   "
112075|NCT02100475|"~     This trial is conducted globally. The aim of the trial is to compare sequential addition of~     insulin aspart versus further dose increase with insulin degludec/liraglutide in subjects~     with type 2 diabetes mellitus, previously treated with insulin degludec/liraglutide and~     metformin and in need of further intensification.~      This is an extension to trial NN9068-3952, NCT01952145 (DUAL™ V).~   "
112076|NCT02100462|"~     This will be a randomized, double-blinded, three-period crossover study of platelet~     activation and aggregation in 30 non-smoking healthy volunteers comparing chlorthalidone~     (CTD), hydrochlorothiazide (HCTZ), and aspirin (ASA; active control). The study hypothesis is~     that CTD has different effects on platelet activation and aggregation than HCTZ.~   "
112077|NCT02100449|"~     In infectious lung consolidations, the inhibition of hypoxic pulmonary vasoconstriction (HPV)~     results in a higher regional acceleration time (RAcT) compared to the RAcT measured in~     atelectatic consolidations.~   "
112078|NCT02100436|"~     This is a Phase II open-label study in approximately 240, and up to 400, healthy males and~     non-pregnant females, aged 6 months to 17 years. This study is designed to assess the safety,~     reactogenicity, and immunogenicity of two doses administered intramuscularly approximately 21~     days apart of an unadjuvanted subvirion monovalent inactivated influenza H3N2v vaccine~     manufactured by sanofi pasteur. Subjects will be stratified by age (approximately 60-100~     subjects 6-35 months old, approximately 60-100 subjects 3-8 years old and approximately~     60-100 subjects 9-17 years old) to receive 2 doses of vaccine, administered intramuscularly~     as 15mcg HA/0.5mL dose, approximately 21 days apart. In addition, approximately 60-100~     subjects 6-35 months old will receive 2 doses of vaccine, administered intramuscularly as~     7.5mcg HA/0.5mL dose, approximately 21 days apart. The duration of the study for each subject~     will be approximately 7 months.~   "
112079|NCT02100423|"~     This phase II trial studies the efficacy (activity), and tolerability of curcumin and~     cholecalciferol combination in treating patients with previously untreated stage 0-II chronic~     lymphocytic leukemia or small lymphocytic lymphoma. Curcumin and cholecalciferol may prevent~     or slow the growth of cancer cells.~   "
112080|NCT02100410|"~     The purpose of this study was to evaluate the axis location of toric contact lenses after 3~     minutes of wear. During this 1-visit study, each participant wore 3 pairs of study lenses of~     various design iterations (2-87-1, 2-87-2, 2-87-3) for an exposure time of approximately 30~     minutes each. Each pair consisted of lenses of the same design iteration, 1 lens with~     embossed mark [TEST1 (T1), TEST3 (T3), TEST5 (T5)], worn on the right eye, and 1 lens without~     embossed mark [TEST2 (T2), TEST4 (T4), and TEST6 (T6)] worn on the left eye.~   "
112081|NCT02100397|"~     Enteric fever is responsible for over 20 million illnesses and 200,000 deaths each year. S.~     Paratyphi A accounts for a substantial and increasing proportion of these cases, as high as~     90% in some regions of Asia. There are currently no vaccines directed against S. Paratyphi A,~     although there some candidates in preclinical and phase 1 trials. This study is funded by the~     European Vaccine Initiative and the Bill and Melinda Gates Foundation. Paratyphoid is a~     human-restricted infection, for which there are currently no small animal models available.~     In order to further our understanding of the host-pathogen interactions, this study will~     develop a novel human challenge model in which to investigate this infection, using a recent~     successful typhoid challenge model as its template.~      Healthy subjects to ingest a dose of Salmonella enterica serovar Paratyphi A, strain NVGH308,~     after drinking a bicarbonate buffer. Intensive follow up over 14 days will establish whether~     each participant meets clearly defined criteria for diagnosis of paratyphoid infection.~     Statistical analysis will be performed on this outcome will determine if it consistently~     gives an attack rate of 60 to 75%. If this is not reached with the first cohort of 20~     participants, the dose will be escalated and the process repeated. A maximum of 80~     participants will be enrolled. Total follow up will be over the course of one year.~     Descriptive clinical and laboratory data collected from participant observations, samples of~     blood, faeces, urine and saliva will allow insights into the disease and the host response.~     These insights will forward our knowledge of paratyphoid disease and may help discover or~     develop diagnostic methods.~      This study is funded by the European Vaccine Initiative and the Bill and Melinda Gates~     Foundation. Paratyphoid is a human-restricted infection, for which there are currently no~     small animal models available. In order to further our understanding of the host-pathogen~     interactions, this study will develop a novel human challenge model in which to investigate~     this infection, using a recent successful typhoid challenge model as its template.~      Healthy subjects will ingest a dose of Salmonella enterica serovar Paratyphi A, strain~     NVGH308, after drinking a bicarbonate buffer. Intensive follow up over 14 days will establish~     whether each participant meets clearly defined criteria for diagnosis of paratyphoid~     infection. Statistical analysis will be performed on this outcome will determine if it~     consistently gives an attack rate of 60 to 75%. If this is not reached with the first cohort~     of 20 participants, the dose will be escalated and the process repeated. A maximum of 80~     participants will be enrolled. Total follow up will be over the course of one year.~     Descriptive clinical and laboratory data collected from participant observations, samples of~     blood, faeces, urine and saliva will allow insights into the disease and the host response.~     These insights will forward our knowledge of paratyphoid disease and may help discover or~     develop diagnostic methods. Anticipating the development of a successful live challenge model~     through this study, there will be the possibility of evaluating novel paratyphoid vaccines~     that are currently in early clinical phase testing. This serves an important function because~     field trials in endemic areas are expensive and time consuming. Speeding up this process~     using our model will be of great benefit to endemic areas.~   "
112082|NCT02100384|"~     Nowadays, dental implants are a very attractive and affordable treatment option for patients.~     According to the American Society of Implant Dentistry the dental implant market in the U.S~     is projected to reach $1.3 billion by 20101. Despite the high success rates of dental~     implants, it is clear that osseointegrated implants are susceptible to diseases. The~     prevalence of dental implant complications are rising as the number of individuals that are~     receiving implant treatment is also increasing. One of these peri-implant complications is an~     inflammatory condition known as peri-implant mucositis that occurs in 64.6% to 80% of the~     implant population.~      The lack of preventive maintenance therapy in subjects with peri-implant mucositis is~     associated with a high incidence of peri-implantitis, which eventually may lead to implant~     loss. One important method in the prevention of peri-implant mucositis is the reduction in~     plaque accumulation, through individual oral hygiene procedures and regular peri-implant~     professional maintenance. It is highly important that patients be educated about the~     importance of developing good oral hygiene habits and to attend regular periodontal~     maintenance appointments. The clinicians have to recognize the significance of monitoring and~     maintaining peri-implant health.~      Unfortunately, it is unclear which of the different maintenance regimens and treatments~     strategies for peri-implant mucositis and peri-implantitis are more effective. There is lack~     of information about which peri-implant maintenance protocol offers the best outcome in terms~     of reduction of inflammation and improved patient comfort. According to Grusovin et al,~     there is only low quality evidence for which are the most effective interventions for~     maintaining or recovering health of peri-implant soft tissues and there is no reliable~     evidence as to which regimens are most effective for long term maintenance. Moreover,~     current approaches to implant maintenance are somewhat haphazard and not standardized.~      It is assumed that what is appropriate for teeth is also beneficial for implants; as stated~     by Persson et al, 2010 therapies proposed for the management of peri-implant diseases are~     currently based on the evidence available from the treatment of periodontitis. Two~     conventionally used methods of biofilm and calculus removal from teeth in North America are~     hand instruments (curettes and scalers) and ultrasonics. In teeth these two modalities of~     treatment have been studied extensively; conversely, there are fewer studies on dental~     implants. Renvert et al, 2008 concluded that mechanical non-surgical treatment might be~     effective to treat peri-implant mucositis but not peri-implantitis; however, the data~     supporting this literature review was scarce. The same research group compared ultrasonic~     instrumentation with specific-implant tips to titanium curettes in the treatment of~     peri-implantitis founding no group differences in the treatment outcomes with improvements in~     plaque and bleeding scores but no effects on probing depths. In addition, both methods failed~     to eliminate or reduce bacterial counts and no group differences were found in the ability to~     reduce the microbiota in a six months period.~      One of the main concerns for dental implants is that metal scalers and ultrasonics generate a~     roughened surface on the implant, which in turn facilitates plaque accumulation and therefore~     makes maintenance of plaque free surfaces more difficult. It was observed in a recent study~     that special coated scalers and ultrasonic tips have been shown in vitro to be compatible~     with implant surfaces, however this has not been confirmed in vivo. The previous finding is~     in agreement with a current study, which demonstrated that the roughness values of the~     titanium surface of implants treated with piezoelectric ultrasonic scalers with a newly~     developed metallic tip and plastic hand curettes, are equal to the surface's roughness of~     untreated implants. Mann et al, 2012 showed in an in vitro study that plastic-coated scalers~     cause minimal damage to the implant surface but leave plastic deposits behind on the implant~     surface, suggesting further research is needed to evaluate the use of such plastic tips in~     the debridement of implants.~      An additional factor, in evaluating the efficacy of different instrumentation in peri-implant~     maintenance, which needs to be taken into consideration, is patient perception. There is~     currently no data evaluating patient perception of comfort in regards to hand vs. ultrasonic~     instrumentation. This information is very important because should both methods of~     debridement be considered of equal efficacy, patient preference may play a role in the~     practitioner's selection of instrumentation. Knowing that patient comfort will increase the~     patient's compliance to the maintenance therapy, further evaluation of this factor is~     necessary.~   "
112083|NCT02100371|"~     This is an extension study of Protocol CA194002 to allow 2 specific participants with basal~     cell nevus syndrome in the CA194002 study at Princess Margaret Cancer Centre who are still~     benefitting from the study drug BMS-833923 to continue receiving the study drug. This study~     will continue to evaluate the safety and tolerability of BMS-833923 in these participants.~   "
112084|NCT02100358|"~     Functional magnetic resonance cholangiography (fMRC) with gadoxetate disodium (Eovist) is an~     accurate method of diagnosing acute cholecystitis.~   "
112085|NCT02100345|"~     Background: Endometriosis is a disease affecting 8-15 % of fertile women and is a cause of~     abdominal pain and suffering during women's menstrual periods. A subgroup of patients with~     DIE has an infiltration into the rectosigmoid bowel wall (4-37%). Knowledge of the growth~     pattern of rectosigmoid lesions related to subjective symptoms is mandatory in order to~     assess the need for follow-up with transvaginal ultrasound during medical treatment.~      Hypotheses:~      Symptoms will follow growth of rectosigmoid endometriosis.~      Material and methods:~      Two different cohorts of women, based on time of diagnosis of rectosigmoid endometriosis and~     treatment with hormonal intrauterine device or continuous oral contraceptives will receive a~     questionnaire and a transvaginal ultrasound scan (measuring size and volume) at inclusion,~     (6) and 12 months later.~      Perspectives:~      Patients treated conservatively may be followed by questionnaires, thereby reducing the need~     for time consuming clinical controls.~   "
112086|NCT02100332|"~     The purpose of this study is to establish the prevalence of comorbidities in Italian patients~     with chronic bronchitis with at least 2 exacerbations per year, and to document the~     appropriateness of instrumental diagnostic tests, such as spirometry of these patients.~   "
112087|NCT02100319|"~     The purpose of this study is to evaluate the efficacy of azilsartan tablets (Azilva Tablets)~     in patients with hypertension complicated by diabetes mellitus whose blood pressure cannot be~     sufficiently reduced by monotherapy with angiotensin II receptor blockers (ARBs) other than~     azilsartan, in routine clinical practice~   "
112088|NCT02100306|"~     Stroke is one of the leading causes of disability, with an estimated prevalence of 50,000~     cases per year in Canada. Less than half of stroke patients regain use of their arm and hand.~     There is currently no intervention regime that is the gold standard, despite the variety of~     therapeutic techniques used to treat the upper extremity post-stroke. The use of external~     feedback to improve motor learning is a technique that has been less studied but shows~     promise. Therefore, the purpose of this proof of principle study it to test whether different~     auditory feedback frequencies can facilitate reaching ability in people with stroke. In~     addition brain scans will be collected that will enable us to determine how stroke severity~     may impact on one's ability to improve with this technique.~      We hypothesize that patients who receive less feedback (50% alternate) will have enhanced~     learning relative to the patients who receive more feedback (100%).~   "
112089|NCT02100293|"~     This study aims to evaluate effects of magnesium sulfate on onset and duration of low dose~     rocuronium, intubation condition and surgical condition.~   "
112090|NCT02100280|"~     This study is a multicenter, randomized, controlled, double-blinded, and parallel design~     study. A total of 96 patients were decided to be recruited considering a 10% dropout rate.~     Patients are randomized to receive a deep block or a moderate block. The randomization~     numbers are generated using a computer-generated randomization code (1) and are sealed in the~     opaque envelope until they are handed over to the anesthesiologist in charge of anesthesia~     management after the induction of anesthesia. Patients, surgeons reporting the scale of~     surgical status, and another researcher analysing the cytokines levels are blinded to the~     patient group. Patients aged 18-65 yr, ASA 1 or 2, and are scheduled for elective~     laparoscopic gastrectomy are included. Patients with severe respiratory or cardiac disease,~     hepatic or renal function impairment, on medications affecting neuromuscular function, and~     with known allergy to the drugs to be used are excluded.~   "
112091|NCT02100267|"~     The purpose of this study is to evaluate efficacy and safety of Methacholine Chloride~     challenge test in diagnosis of adult asthma~   "
112092|NCT02100254|"~     This randomized clinical trial studies narrative or fact-based videos in increasing~     colorectal cancer screenings in African American communities. Informational videotapes may~     help increase the number of participants who engage in colonoscopy screenings. It is not yet~     known whether narrative videos may be more effective than fact-based videos in increasing~     colorectal cancer screenings.~   "
112093|NCT02100241|"~     The purpose of this study is to determine whether active stretching with low frequency~     currents are more effective than active stretching in the treatment of hamstring shortness~     syndrome in children.~   "
112094|NCT02100228|"~     Some people can develop an abnormal heart beat known as Atrial fibrillation or AF that~     puts them at risk of developing clots in the heart. Those clots can travel in the blood~     circulation to the brain and cause a brain attack (a stroke). To prevent those clots~     forming, blood thinners (anti-coagulants) are used. Apixaban is a blood thinner that works by~     stopping one of the blood substances required for clotting (Factor Xa). It is approved and~     used to prevent clots forming in people with AF. Other established blood thinners work by~     stopping clotting substances being made, known as Vitamin K antagonists or VKAs. An~     example of this type is Warfarin (Coumadin). The good effects of all blood thinners are~     preventing clots, and they may also have bad effects of increasing the chance of bleeding.~     People with AF, abnormal heart beat, may benefit from changing it back to a normal regular~     rhythm, known medically as cardioversion. When this is done, people are currently most~     commonly treated with a VKA blood thinner (e.g. warfarin). The purpose of this study is to~     assess the good and bad effects (efficacy and safety) of apixaban compared with warfarin~     in people with AF in whom an early cardioversion is planned.~   "
112095|NCT02100215|"~     The purpose of this study is to learn more about the effects of various types of simulation~     preparation methods on novice nurses' competence and self-efficacy. Participants will be~     recruited from an academic course (N424 Integrated Practicum). Participants will be~     randomized to three intervention groups (i.e. expert modeling video, voice over PowerPoint,~     and traditional readings). All participants will complete self-efficacy surveys and two~     simulations. During simulation, participants will be scored based on their competence~     according to a performance rubric. The hypothesis is that participants in the expert modeling~     group will demonstrate more change in competence and report more change in self-efficacy~     scores than participants in other groups.~   "
112097|NCT02100189|"~     This clinical trial studies whether esophageal cytology plus fluorescence in situ~     hybridization (FISH) is equal to or better than esophago-gastro-duodenoscopy (EGD) or upper~     endoscopy for the early detection of esophageal cancer. Genes are the units of~     deoxyribonucleic acid (DNA) the chemical structure carrying genetic information that~     determine many human characteristics. Certain genes in cancer cells may determine how the~     tumor grows or spreads and how it may respond to different drugs. Part of this study is to~     test those genes in esophageal cells using FISH.~   "
112098|NCT02100176|"~     To test whether a multidisciplinary intensive rehabilitation treatment (MIRT) slowed down the~     progression of the disease in Parkinson's disease (PD) de novo patients, all treated with~     Rotigotine, in a randomized controlled study with a 18 months follow-up.~   "
112099|NCT02100163|"~     The treatment of postoperative pain after severe trauma is poorly understood, and it can lead~     to chronic pain, opiate drug addiction and elevated health care costs. The proposed project~     will be a randomized controlled trial to evaluate an innovative methodology for delivering~     clinical hypnosis (virtual reality hypnosis) for pain control as well as a more time-honored~     delivery system that uses audio recordings. The goal will be to reduce postoperative pain in~     a sample of patients hospitalized for the care of severe orthopedic trauma. This proposal~     will test innovative and low-risk approaches to reducing postoperative trauma pain that are~     designed to reduce pain, anxiety and other complications after surgery. The findings have the~     potential not only to reduce pain and suffering in patients who have suffered severe~     orthopedic trauma but could be applicable to the millions of people who have surgery every~     year. Reducing addictive opiate-based medication and health care costs are both potential~     outcomes from this project.~   "
112100|NCT02100150|"~     The purpose of this study is to determine whether NNZ-2566 is safe and well tolerated in the~     treatment of mTBI in adolescents and adults.~   "
112101|NCT02100137|"~     The purpose of this study is to evaluate the clinical meaning of an endometrial hyperplasia~     diagnosed using a vaginal ultrasound during routine gynecological examination.~   "
112102|NCT02100124|"~     The purpose of this web-based study is to determine whether reproductive life planning (RLP),~     with or without contraceptive action planning (RLP+), will result in reduced risk of~     unintended pregnancy when compared to an information-only control group.~   "
112103|NCT02100111|"~     This multi-center, observational study involves reviewing the medical records of~     approximately 100 adult participants diagnosed with advanced BCC from 01 January 2005 until~     31 December 2010. Participant records will be analyzed to identify participant~     characteristics, treatment patterns and clinical outcomes.~   "
112104|NCT02100098|"~     The purpose of this exploratory study is to characterize the postoperative pain profile of~     patients undergoing operation with internal fixation of an ankle fracture under nerve block~     anaesthesia. Special attention is payed towards the possible existence and clinical relevance~     of a rebound pain phenomenon upon cessation of the nerve block.~      Results are used to guide the set up of a randomized controlled trial on the subject.~   "
112105|NCT02100085|"~     This study is to follow up on the change of immune response by measuring HPV type 16/18 E6~     and E7 specific T cell response and lesion condition in subjects who have administered in~     DNA-based therapeutic vaccine.~   "
112106|NCT02100072|"~     The purpose of this study is to evaluate the safety and efficacy of the Nd:YAG 1440 nm~     wavelength laser for the treatment of primary hyperhidrosis of the axilla.~   "
112107|NCT02100059|"~     To determine changes in thigh muscle function and knee pain after a partial meniscectomy~     surgery and to also determine the effects of applying electrical stimulation to the knee to~     determine if this improves thigh muscle function and decreases pain.~   "
112108|NCT02100046|"~     Currently, it is established that the voltage-gated calcium channels modulate pain perception~     due to an influence on the neuronal transmission and excitability. In the past, attention has~     focused on the modulation of high voltage activated calcium channel. More recently,~     scientific interest has proven to the low voltage activated calcium channel, also called~     T-type channels. The data from the literature show significant involvement of these channels~     in the physiology of nociception and pathophysiology of acute and chronic pain. Moreover, in~     several animal pain models (acute, neuropathic, inflammatory), T-type channels inhibition~     alleviates painful behaviours.~      Analgesics treatments available in clinic are ineffective in some patients with chronic pain~     (neuropathic, inflammatory) and often induce deleterious side effects. Thus, the clinical use~     of selective inhibitors of T-type channels could not only help the development of new~     therapies for the treatment of neuropathic pain (prevalence = 5-8 %), but also have a~     pharmaco-economic impact due to the low selling price of their inhibitor currently available:~     Zarontin®.~      The purpose of this study is to assess the effectiveness of ethosuximide (Zarontin®) on the~     pain symptoms and quality of life in patients with peripheral neuropathic pain compared to a~     control group.~   "
112109|NCT02100033|"~     De-qi as an important factor to therapeutic effect of acupuncture for years, It's a concrete~     pathway to approach Qi, an abstract concept in Chinese medicine. However, all previous~     physicians and medical scientists have different interpretation to De-qi, and no objective~     principles for clinical practice, teaching and studies.~      Qi propagated combined with acupuncture practice always be seen as De-qi , therefore, the~     study control transmission or not and direction of sensation propagated to compare what's~     different in human body. If the change happened as prediction based on acupuncture theories,~     it could define De-qi for operation.~      The study will collect 60 subjects, from age 20 to 40, the same numbers of male and female.~     They will accept different manipulation in left hand HeGu(LI4), and assessed the variations~     in microcirculation, temperature of left forearm, and waxing/waning of yin-yang , Qi and~     blood in related meridian. We hope to understand if sensation propagated is primary factor of~     De-Qi and acupuncture effect .~   "
112121|NCT02099877|"~     In this prospective observational double-blind study, the investigators aim to assess the~     effect of the single nucleotide polymorphism of the μ-opioid receptor gene (OPRM1, p.118A/G)~     on the duration of epidural fentanyl labor analgesia.~   "
112244|NCT02098278|"~     The purpose of this study is to assess safety and efficacy of CAT-2003 in patients with~     chylomicronemia. The study will evaluate the effects of CAT-2003 on fasting total and~     chylomicron triglyceride levels, as well as postprandial total and chylomicron triglyceride~     clearance.~      This is a single-blind study. All patients will receive placebo for 1 week, and CAT-2003 for~     12 weeks during the 13 week treatment period.~   "
112110|NCT02100020|"~     The proposed project will evaluate two methods of implementation of the new Physical Activity~     Guidelines (PAGs) for Adults with Multiple Sclerosis (MS) living in two Ontario communities.~     The investigators will also determine if following the PAGs will improve aspects of fitness,~     function, quality of life and risk for cardiometabolic disease in this population. The~     investigators hypothesize that adherence to the PAGs will be higher in people who have been~     referred directly to a community-based exercise program, and that this greater adherence to~     physical activity will be associated with greater improvements in fitness, function and~     quality of life.~      This randomized controlled trial will provide important information on how best to implement~     physical activity recommendations within the community setting; this information will be~     translated to key stakeholders during the final stages of the project.~   "
112111|NCT02100007|"~     The purpose of this study is to determine the safety and tolerability of ME-344 when given in~     combination with Hycamtin® in patients with solid tumors~   "
112112|NCT02099994|"~     The study is part of a long-term aim to develop an effective HIV-1 vaccine and will evaluate~     safety and immunogenicity of vaccines focusing T cell responses on the conserved region of~     the HIV-1 proteome. The vaccines used are pSG2.HIVconsv DNA (D), MVA.HIVconsv (M) and~     Ad35-GRIN (A), delivered in regimens AM, DDDAM and DeDeDeAM, where e indicates~     electroporation.~   "
112113|NCT02099981|"~     Diabetic retinopathy is the leading cause of blindness in the developed world. The causes of~     the disease are poorly understood. One of the earliest changes that occur in the retinas of~     diabetic patients, well before overt retinopathy is observed, is a reduction in light-evoked~     increases in blood flow in retinal vessels. The loss of this vascular response may lead to~     retinal hypoxia and it has been suggested that hypoxia could be a principal cause of diabetic~     retinopathy.~      The long-term goals of this project are to determine whether decreased blood flow in diabetic~     patients and the resulting retinal hypoxia contributes to the development of diabetic~     retinopathy and whether restoration of normal blood flow in diabetic patients slows or~     prevents the development of retinopathy.~   "
112114|NCT02099968|"~     Different forms of diet, e.g. Mediterranean diet, DASH diet, or fasting, have demonstrated~     efficacy in reducing elevated blood pressure. Moreover, Mediterranean diet, and fasting seem~     to be effective in improving insulin sensitivity in type 2 diabetes. Further, studies on~     meditation or mindfulness-based interventions have shown positive effects in patients with~     hypertension and/or type 2 diabetes. Comprehensive Lifestyle Modification, this is a~     combination of diet, exercise, and stress management, have improved coronary atherosclerosis.~     However, no studies have yet investigated the effects of Comprehensive Lifestyle Modification~     in patients with metabolic syndrome and/or in combination with fasting therapy.~      This study is supported by a grant from the Corona-Foundation, Germany.~   "
112115|NCT02099955|"~     Studies have shown that individuals who have suffered a spinal cord injury are at an~     increased risk of Vitamin D deficiency compared to able-bodied individuals. It has recently~     been shown that Vitamin D deficiency is linked to a large number of diseases and conditions,~     including chronic lung disease, vascular problems, and insulin resistance. If this common~     nutritional deficiency is proven to be the cause of some of these diseases and conditions in~     persons with SCI, then it may easily be remedied with a cheap and effective therapeutic~     approach: vitamin D replacement therapy. Because of the high prevalence of vitamin D~     deficiency in persons with SCI, this therapy alone or in combination with other treatment~     options will be expected to significantly improve overall well being in the SCI population,~     decrease hospitalization rate, and the lower the financial burden of care.~   "
112116|NCT02099942|"~     This registry is designed to monitor the real world clinical performance and safety of the V8~     device used to perform balloon aortic valvuloplasty (BAV). Additional analyses or~     calculations may be obtained from the imaging or evaluations already performed per the sites'~     standard of care~   "
112117|NCT02099929|"~     Epidemiological studies have shown an inverse association between coffee consumption and risk~     of type 2 diabetes mellitus (T2DM). However the experimental studies that analysed the~     mechanisms are limited.~      This project aims to assess the effects of coffee consumption on glucose metabolism, using~     stable isotope tracer (13C-glucose) to explain the possible metabolic mechanisms involved on~     the reduced risk for T2DM.~   "
112118|NCT02099916|"~     Poor responders to ovarian stimulation represents one of the most frustrating problems in~     reproductive medicine. The investigators hypothesize that ovarian response of those patients~     could improve by treating these patients with 25 mg DHEA tid for 12 weeks prior to~     stimulation.~   "
112119|NCT02099903|"~     It is a randomized prospective controlled study of transcatheter renal denervation in~     patients with systolic heart failure secondary to Chagas' disease. The purpose of the study~     is to evaluate the safety and effectiveness of renal denervation in patients with Chagas~     heart disease, due to reduction in renal and systemic sympathetic activity.~   "
112120|NCT02099890|"~     Spinal cord Injury (SCI) is a condition commonly associated with a state of chronic low-grade~     inflammation due to a variety of factors such heightened risk for infection and development~     of metabolic disorders. Many disorders which have been demonstrated to have an inflammatory~     basis have also been found to be at much higher prevalence following SCI. Such conditions~     include, but are not limited to, depression, cognitive impairment, neuropathic pain, and~     somatic/autonomic nerve function. The fact that such disorders have an inflammatory basis~     provides a unique opportunity to treat them with intervention strategies which target the~     immune system. Natural anti-inflammatory interventions including a diet consisting of foods~     and supplements with anti-inflammatory properties may be an effective option for treating~     inflammation in this population. As this treatment strategy will target the inflammatory~     basis of many disorders it would be expected to lead to a reduction in pro-inflammatory~     mediators thereby leading to more sustainable long-term immune improvements regarding enzyme~     function and protein balances. Despite this, surprisingly little research has focused on the~     use of anti-inflammatory foods for the treatment of chronic inflammatory conditions, and~     effects specific to SCI have been almost completely neglected. As such, the current study~     will focus on the daily intake of natural supplements with anti-inflammatory properties over~     a 3 month intervention and the effects on inflammation and associated disorders will be~     assessed. It is hypothesized that the supplementation will result in positive alterations in~     enzyme regulation and protein balances resulting in improvements in each of the outcome~     measures of interest.~   "
112122|NCT02099864|"~     This clinical trial studies genetic and molecular mechanisms in assessing response in~     patients with prostate cancer receiving enzalutamide therapy. Androgens can cause the growth~     of prostate cancer cells. Antihormone therapy, such as enzalutamide, may lessen the amount of~     androgens made by the body. Studying samples of tissue and blood in the laboratory from~     patients with prostate cancer may help doctors better understand castration-resistant~     prostate cancer. It may also help doctors make improvements in prostate cancer treatment.~   "
112123|NCT02099851|"~     This is a prospective, observational, multicenter trial to evaluate the safety and~     feasibility of selective endovascular unilateral carotid body ablation in patients with~     treatment-resistant hypertension. All patients will be followed for two (2) years following~     treatment.~   "
112124|NCT02099838|"~     Secondary failure of sulfonylureas (SUs) can occur in about 30%-40% of type 2 diabetic~     patients after treatment with SUs for 5 years, although SUs are widely used in type 2~     diabetic patients. This study was designed to evaluate the effectiveness and safety of adding~     compound preparation of pioglitazone and metformin for type 2 diabetic patients who have bad~     glycemic control with the initial treatment of SUs.~   "
112125|NCT02099825|"~     The purpose of this research study is to determine whether taking a one-time dose of a~     combination of putatively learning-enhancing medications can improve treatment response to a~     brief learning-based psychotherapy for public speaking anxiety. The two medications are (1)~     d-cycloserine (DCS), a medication that is an agonist (facilitator) of the NMDA glutamatergic~     receptor and has been shown in previous studies to facilitate some kinds of learning and~     memory; and (2) mifepristone, a medication that blocks cortisol, and in preclinical (animal)~     studies has been shown to reverse certain kinds of stress-related learning impairment or~     negative learning.~      Specifically, the investigators goal is to determine if DCS and mifepristone taken together~     augment the learning that occurs during a brief psychotherapy session---a public speaking~     exposure exercise. Evidence for this learning effect would be a finding that participants~     have reduced anxiety at subsequent public speaking exposures.~   "
112126|NCT02099812|"~     Low socioeconomic status (low SES), as defined by educational attainment and income, has been~     associated with obesity in industrialized nations. Low SES has been related to impulsive~     decision-making characterized by steep devaluation of future outcomes (delay discounting, DD)~     and a greater motivation to obtain food (food reinforcement, FR). DD and FR have been shown~     to interactively predict ad libitum energy intake in laboratory studies, such that~     participants exhibiting high FR as well as high DD consume the most food. Obesity often~     results from energy intake in excess of physiologic needs, and thus a plausible mechanism is~     that low SES environments increase FR and DD, leading to overeating and obesity. The primary~     aims of this study are to determine whether FR and DD interact to predict BMI, and whether~     differences in FR and DD mediate the relationship between low SES and obesity, in a large~     sample of US adults of varying BMI. In addition, whether high FR and high DD are related to~     unhealthy food purchasing and eating behaviors will be assessed. It is anticipated that high~     FR and DD will be related to unhealthy food purchasing and eating behaviors.~   "
112127|NCT02099799|"~     COPD currently afflicts 24 million US residents; the prevalence of COPD is high among~     Veterans. Persons with COPD have significant functional disability as a result of the~     disease. This project will determine whether a novel Internet-mediated walking program~     coupled with a pedometer can improve exercise capacity, improve health-related quality of~     life, and decrease the risk of acute exacerbations in persons with COPD. If successful, based~     on estimates that 33 to 64% of COPD patients are Internet users, the proposed exercise~     intervention could help over 8 million persons. The Veterans Health Administration (VHA) has~     a strong commitment to providing care to persons with COPD and supporting research directed~     at COPD-related disability. The 2012-2016 Strategic Plan of the VHA Office of Research and~     Development includes research in COPD rehabilitation. The proposed research addresses~     Rehabilitation R&D Service's current priority area of improving disabled Veterans'~     health-related quality of life by reducing disease burden and maximizing functional recovery.~   "
112128|NCT02099786|"~     This study involves research. Some chemotherapeutic drugs that can permanently reduce hearing~     are termed ototoxic. One such drug is the chemotherapy called cisplatin. Currently, if a~     patient is receiving cisplatin, hearing is tested in the Audiology Clinic using lengthy~     protocols and may be retested only when it is requested by their oncologist and when the~     Veteran can arrange an appointment. Researchers think that hearing testing prior to every~     treatment of cisplatin may reduce the number of Veterans who get disabling hearing loss from~     treatment. The purpose of this study is to compare the current method of monitoring hearing~     (audiology clinic protocols termed usual care) with a new portable hearing monitoring~     program (a comprehensive program of ototoxicity monitoring termed COMP-VA) that tests~     hearing using a portable hearing testing audiometer and a variety of efficient tools and~     techniques so that testing can occur prior to each cisplatin treatment at any quiet location~     in the hospital.~   "
112129|NCT02099773|"~     This exploratory and observational study focuses on adults with an intellectual disability~     (ID) and their support workers. Two groups of clients are observed: clients using Key Word~     Signing, and clients using aided Augmentative and Alternative Communication (AAC).~     Approximately half of adults with ID is estimated to experience communication difficulties.~     AAC supports them in their daily communication aiming at optimal participation in society.~     Current communication models, such as Participation Model (Beukelman & Mirenda, 2005) and~     International Classification of Functioning, Disability and Health (WHO, 2001), regard both~     client-related and environmental factors as important elements of communication. A~     substantial part of the environmental factors is made up of the communication partners'~     characteristics. In daycare and residential services for adults with ID the support worker is~     an important communication partner .~   "
112142|NCT02099604|"~     The purpose of this study is to show the superiority of a 4 weeks lead-in phase of Vitamin D~     followed by a 48 weeks combination of Vitamin D with PEG-IFN plus RBV in comparison with~     standard PEG-IFN + RBV in untreated Egyptian patients with chronic hepatitis C, on the~     sustained virological response (SVR) at 3 months after end of treatment (week 60).~   "
112143|NCT02099591|"~     To characterize the pharmacokinetics (PK) of naloxegol after single oral dose and through~     population PK in paediatric patients with opioid induced constipation (OIC).~   "
112130|NCT02099760|"~     The purpose of this study is to validate Xpert CT/NG for the detection of CT and GC in rectal~     samples as part of the PA DOH and CLIA requirements. The evaluation of samples obtained from~     the pharynx is exploratory and will provide new information on the frequency of pharyngeal~     infection due to CT and GC.~      A secondary objective will be to evaluate the prevalence of Trichomonas vaginalis in vaginal~     and rectal samples using both the Xpert system and AC2 to assess whether women positive for~     this pathogen rectally usually or always have vaginal infection due to this pathogen.~      The investigators hypothesis is that real-time PCR (polymerase chain reaction) amplification~     testing with the Cepheid Xpert CT/NG will have greater sensitivity than culture in detecting~     Neisseria gonorrhoeae in rectal samples. The investigators also hypothesize that Xpert CT/NG~     will be equivalent to the Gen-Probe APTIMA Combo2 (AC2) in detecting Chlamydia trachomatis~     and Neisseria gonorrhoeae in rectal samples.~   "
112131|NCT02099747|"~     The null hypothesis of no difference in CR% at 3 months between the arms will be tested~     against the alternative of a difference in CR% at an alpha level of .05 by assessing the odds~     ratio for arm yielded by this model.~   "
112132|NCT02099734|"~     This study is being done to create a registry to help us learn more about germ cell tumors~     (GCT) and other testicular tumors. The registry will include people with these tumors and~     also relatives and unrelated people without these tumors. This study will help us learn more~     about the prevention, diagnosis, treatment and outcome of these tumors. Studying relatives of~     patients and people unrelated to patients with GCT and other testicular tumors will help us~     understand why some people get these tumors and why some people don't.~   "
112133|NCT02099721|"~     The purpose of this study is to demonstrate that primary prevention patients with one or more~     additional risk factors (1.5 prevention criteria: syncope/pre-syncope, non-sustained~     ventricular tachycardia (NSVT), frequent pre-ventricular contractions (PVCs), and low left~     ventricular ejection fraction (LVEF)) are at a similar risk of life-threatening ventricular~     arrhythmias (LTVA) when compared to secondary prevention patients, and would receive similar~     benefit from an implantable cardioverter defibrillator (ICD), or cardiac resynchronization~     therapy- defibrillator (CRT-D) implant.~   "
112134|NCT02099708|"~     The purpose of this study is to investigate the safety and efficacy of long-term~     administration of lansoprazole (Takepron) therapy for up to 12 months in the routine clinical~     setting in patients receiving oral non-steroidal anti-inflammatory drugs (NSAIDs)~   "
112135|NCT02099695|"~     Treatment of primary hyperhidrosis through a comparative study between oxybutynin~     hydrochloride and placebo.~      Hydrochloride may decrease the symptoms of hyperhidrosis improving the subject's quality of~     life.~   "
112136|NCT02099682|"~     The purpose of this study is to investigate the safety and efficacy of long-term~     administration of lansoprazole (Takepron) for up to 12 months in the routine clinical setting~     in patients receiving low-dose aspirin~   "
112137|NCT02099669|"~     Myelodysplastic syndromes (MDS) are bone marrow malignancies characterized by poor bone~     marrow function that may progress to acute myeloid leukemia. Many patients become red blood~     cell transfusion-dependent. Transfusion dependence is associated with inferior quality of~     life (QOL). However, the relationship between the degree of anemia and QOL is less clear. A~     commonly used transfusion strategy is to target the hemoglobin (Hb) in the range of 80-90 g/L~     (normal hemoglobin > 120-130g/L). The question is: would a higher hemoglobin target lead to~     improvement in QOL despite the negative impact transfusion dependence may have on QOL (due to~     associated time commitments, expense, transfusion reactions etc). Several groups have~     prospectively shown that targeting hemoglobin levels of greater than 120 g/L (with~     hematopoietic growth factors (HGFs) and/or blood transfusions) or incremental increases of~     15-20 g/L (with HGFs alone) were associated with improved QOL. The investigators MDS program~     has been conducting prospective assessments of QOL since 2007 in all registered and consented~     patients using a variety of validated questionnaires. Preliminary analysis (in 236 patients)~     revealed that, compared with an age-matched healthy general population, MDS patients have~     inferior QOL. Transfusion dependence and anemia were independently predictive of poor~     functioning, fatigue and decreased health utility. Furthermore, a hemoglobin level of ≥100~     g/L seemed to be the key threshold for improvement in function and symptom scores. The~     investigators hypothesize that the target hemoglobins in transfusion dependent MDS patients~     are too low and this may account for their inferior quality of life. Our goal is to compare~     the effect on QOL of a restrictive strategy (which is the current standard of care), with a~     liberal transfusion strategy in a large randomized controlled trial of transfusion dependent~     MDS outpatients. Before embarking on such an endeavor, the investigators must first prove~     feasibility in a smaller pilot randomized controlled trial.~   "
112138|NCT02099656|"~     This Phase II, randomized, double-blind, placebo-controlled, multicenter study will evaluate~     the effects of lebrikizumab on airway eosinophilic inflammation in participants with~     uncontrolled asthma who are using inhaled corticosteroid (ICS) treatment and a second~     controller medication. Enrolled participants will undergo a 3-week screening period during~     which assessments, including a bronchoscopy procedure, will be made. Participants will~     subsequently be randomized to receive lebrikizumab or placebo by subcutaneous (SC) injection~     on Day 1, Day 8, Week 4, and Week 8. Participants will continue their standard of care~     therapy throughout the study. End of treatment assessments will be taken at Week 12. Total~     study period, including screening and follow-up, is expected to last 23 weeks.~   "
112139|NCT02099643|"~     Recent data has demonstrated that focal sources are determinant in human atrial fibrillation~     (AF) perpetuation.~      The investigators sought to identify crucial areas for AF perpetuation during our routine~     electrogram (EGM)-based substrate ablation.~   "
112140|NCT02099630|"~     The study will investigate functional and metabolic changes in the course of antidepressive~     treatments.~      The investigators will apply different imaging methods to investigate the effects of~     antidepressive interventions on resting state neural activity, functional activation during~     cognitive and emotional stimulation, neurotransmitter concentrations as well as~     concentrations of brain- derived neurotrophic factor.~   "
112141|NCT02099617|"~     The main objective of the SENIOR study is to establish the efficacy and safety of the~     everolimus eluting stent with a biodegradable abluminal polymer (SYNERGY II) associated with~     a short dual antiplatelet therapy (DAPT) in patients ≥75 years old, suffering from stable~     angina, silent ischemia (1 month DAPT) or acute coronary syndromes (6 months DAPT) related to~     significant coronary artery disease and requiring percutaneous coronary intervention. The~     primary end point is to demonstrate that SYNERGY II in patients ≥75 years old is associated~     with a lower rate of the composite rate of major cardiovascular and cerebrovascular events~     (all-cause death, myocardial infarction, stroke, ischemia-driven target lesion~     revascularization) and a similar risk of stent thrombosis than bare metal stent at one year.~   "
112156|NCT02099422|"~     Comparison of two antiplatelet strategies between months 1 and 12 after coronary stenting for~     ACS. Efficiency and tolerance évaluation~   "
112144|NCT02099578|"~     Cardiovascular disease (CVD) is the leading cause of death in the US. Statistics show that~     approximately 91% of individuals with CVD have vascular dysfunction. Hypertension is a major~     modifiable risk factor for CVD and approximately 60% of adults in the US are pre-hypertensive~     and hypertensive. In addition, the prevalence of hypertension is associated with aging in~     both genders; however, the increase in blood pressure (BP) in women after menopause exceeds~     that of men.~      The development of effective and safe strategies to improve vascular function is of~     significance as it can have a great impact on quality of life, productivity and economic~     burden for the affected populations. One such alternative would be to introduce into the diet~     food sources that are rich in naturally occurring bioactive compounds. Thus, the long-term~     goal of the investigators is to provide feasible and effective dietary ways for~     postmenopausal women to improve their vascular function and quality of life.~      Strawberries are a rich source of bioactive compounds and its total antioxidant content ranks~     third among all fruits and vegetables. Hence, the purpose of this study is to bring forth~     evidence that incorporation of strawberries into the diet will reduce blood pressure and~     improve cardiovascular function in pre- and stage 1-hypertensive postmenopausal women.~      Sixty eligible postmenopausal women between the ages of 45 and 65 and a seated BP of ≥ 130/85~     mm Hg but ≤ 160/100 mmHg at the screening visit will be randomly assigned to one of three~     groups:~        1. 25 g freeze-dried strawberry powder;~        2. 50 g freeze-dried strawberry powder; or~        3. placebo powder. Participants will be asked to consume the supplements for 8-weeks.~          Medical history, medication use, dietary intake, and physical activity will be assessed~          at 0-, 4-, and 8-weeks followed by blood draw. Serum levels of markers of cardiovascular~          function as well as oxidative stress and inflammation will be measured.~      The investigators hypothesize that regular consumption of strawberry will improve~     cardiovascular function, decrease BP and blood markers of oxidative stress as well as~     inflammation. Investigators also expect the findings of this study to provide a foundation~     for further studies to examine the effects of long-term incorporation of strawberry into the~     diet and the integrity of cardiovascular system.~   "
112145|NCT02099565|"~     The current follow-up study was planned to reveal the rates of Major Adverse Cardiovascular~     and Cerebrovascular Events (MACCE) during 4-year follow-up in patients participated in OPTIMA~     study. In addition, the long-term effects of statins on LDL-cholesterol and different~     biomarkers in patients after drug-eluting stents implantation will be assessed. In addition,~     such project implementation will allow to clarify the treatment options used by Russian~     patients with CAD (Coronary Artery Disease) after drug-eluting stent implantation. The~     information received in this study will help to optimize management of Russian patients with~     CAD after PCI in order to improve prognosis and quality of life of these patients.~   "
112146|NCT02099552|"~     The proposed natural history study will enroll male and female patients, ages 36 months and~     younger, who have a diagnosis of XLHED based on genetic testing and who have not received an~     investigational study drug. The study protocol will include collection of all relevant~     medical history and documentation of clinical outcomes using age-appropriate, minimally~     invasive technologies. Data will be collected both retrospectively, back to pregnancy~     assessments that may be available, and prospectively through age 5 yrs.~   "
112147|NCT02099539|"~     This is a Phase I/II, open-label, multi-center, competitive enrollment and dose escalation~     study of ALT-803 in patients with relapsed or refractory multiple myeloma.~   "
112148|NCT02099526|"~     The goals of the study are to investigate the needs of older (age 60+) caregivers caring for~     adults with cancer at 1-week and 2 weeks following hospital discharge and to explore~     strategies that may assist caregivers in their home caregiving needs. This study will explore~     how these needs vary based on caregiver spirituality and relationship with the care~     recipient.~      The study will enroll cancer patients and their caregivers admitted to 9100 and 9300, which~     are the hematological and non-hematological malignancy units at Duke University Medical~     Center (DUMC) respectively. Results of this study will lay the groundwork for creating~     tailored interventions for caregivers that are compatible to their preferences and more~     responsive to their needs.~   "
112149|NCT02099513|"~     This study develops and pilots the initial interface of our mobile health platform that will~     allow for intra-individual tailoring and personalization of health interventions. This will~     allow for just-in-time interventions that adapt both the content and timing, not just~     initially, but also over time based upon prior outcome data, responses to an intervention,~     current environmental and social context, activity level, location, time, and an individual's~     psychophysiological state.1,2~      Aim 1: To develop the initial interface of the mobile health platform that will allow~     patients to report and receive data representing multiple health domains including blood~     pressure, pO2 (pulse oximeter), values, weight, physical activity, calories burned, sleep,~     and self-report survey measures such as pain and fatigue.~      Aim 2: To assess feasibility of the mobile health platform to receive and deliver data~     representing multiple health domains over 1 month through a single-case study design (N=6).3~     Aim 3: To develop an algorithm using the diet data collected in Aim 1 that will facilitate~     adaptive work by providing patients with automated real time feedback on their progress.~      Aim 4: To develop an algorithm using the diet data collected in Aim 1 that will that will~     facilitate adaptive approaches by alerting clinicians on the progress of their patients.~   "
112150|NCT02099500|"~     This is an open-label, non-randomized, multi center, patient sponsored study of~     Adipose-Derived Stromal Cell (ASC) implantation via intramuscular injections in patients who~     have critical limb ischemia not amenable for revascularization.~      The intent of this clinical study is to answer the questions: 1) Is the proposed treatment~     safe and 2) Is treatment effective in improving the disease pathology of patients with~     diagnosed critical limb ischemia ASCs will be collected from the patient's adipose-derived~     tissue (body fat). Using local anesthesia, Liposuction will be performed to collect the~     adipose tissue specimen. The adipose tissue is then transferred to the laboratory for~     separation of the adipose tissue derived stem cells. In addition, peripheral blood will be~     collected for isolation of platelet rich plasma, which are then combined with the ASC's for~     intramuscular injection into the lower limb.~   "
112151|NCT02099487|"~     To assess the effect of IMRT using VMAT rapidarc approach, followed by adjuvant temozolomide~     on survival and quality of life in elderly, poor performance status patients with newly~     diagnosed HGG.~   "
112152|NCT02099474|"~     The purpose of this study is to assess the evolution of raltegravir concentration in the~     mother (between the 3rd trimester of pregnancy and one month post-delivery) and her neonate,~     when this drug is used to prevent mother-to-child HIV-1 transmission as part of a combined~     antiretroviral regimen.~   "
112153|NCT02099461|"~     To evaluate whether administration of denosumab results in a decrease compared to the control~     group in proliferation of mammary epithelial cells as measured by the Ki-67 proliferation~     index.~   "
112154|NCT02099448|"~     The purpose of the study is to determine the accuracy of non-invasive assessment of LVEDP~     using the investigational device C.A 2.0.~   "
112155|NCT02099435|"~     This study is to evaluate the performance of Hemospray for the teatment of nonvariceal lower~     gastrointestinal bleeding.~   "
112158|NCT02099396|"~     The purpose was to evaluate efficacy, safety and effects on survival for lobaplatin and~     Gemcitabine in combination with Docetaxel, which can provide a kind of completely new~     second-line chemotherapy program for osteosarcoma patients in aggressive-phase, provide~     accurate and reliable evidence-based results for clinical applications of lobaplatin in~     osteosarcoma patients as one of the third-generation of platinum drugs, and further~     consummate and enrich clinical practice guidance on osteosarcoma all over the world.~   "
112159|NCT02099383|"~     The investigators' preliminary findings suggest that providing patients with acute ischemic~     stroke hydration therapy on the basis of their presenting BUN/Cr ratio may help reduce the~     occurrence of stroke-in-evolution(SIE) and therefore improve prognosis.~      The trial will be carried out in two parts. Part 1 assesses the rate of stroke-in-evolution~     72 hours after the onset of stroke as a measure of the activity of BUN/Cr ratio based~     hydration therapy. Part 2, The investigators use two outcome measures, including Barthel~     index, and modified Rankin scale for neurological evaluation to assess whether BUN/Cr ratio~     based hydration therapy results in sustained clinical benefit at three months.~   "
112160|NCT02099370|"~     The investigators are measuring the adherence rates of an oral MS drug that is to be~     administered twice-daily. The investigators would like to observe any patterns that might~     indicate factors that greatly affect adherence.~   "
112161|NCT02099357|"~     The purpose of this study is to determine the effects of creatine monohydrate or vitamin D~     supplementation on strength gains following a traditional resistance training program for~     adults with spinal cord injury.~   "
112162|NCT02099344|"~     Compare Artegraft and Propaten grafts for use in dialysis access to see if one performs~     better than the other. How long each one lasts until a complication arises or until the graft~     is no longer used will be compared.~      The study hypothesis is that the Artegraft, being an actual blood vessel, will work better~     than the manufactured Propaten graft.~   "
112163|NCT02099331|"~     Atrial fibrillation is a common heart rhythm condition that can occur after cardiac surgery~     and has been associated with an increase in hospital length of stay, overall hospital costs,~     worsening clinical condition and higher rates of death. Newer research indicates that~     inflammation is a key contributor to atrial fibrillation in this setting.~      Melatonin is a naturally made hormone that is regarded as an extremely effective~     anti-inflammatory substance, with a very favorable safety profile. This clinical trial is~     being done to test the ability of melatonin to reduce the risk of developing atrial~     fibrillation after cardiac surgery.~      This is a research study where patients will be given either oral melatonin at 40 mg or~     placebo nightly prior to sleep. The study product will start approximately 2 days prior to~     the scheduled surgery date and will continue until the 3rd day after the operation. The~     remainder of the clinical care will remain the same.~      The investigators project that patients who receive melatonin will have a significant~     decrease in the occurrence of atrial fibrillation after surgery.~   "
112164|NCT02099318|"~     Objectives: The objective of this clinical study is to determine if the use of the SRP will~     lead to improved effort and time efficiency in cerebral aneurysm surgery. For this~     preliminary study, the investigators will assess key time and effort variables associated~     with prospectively assessed SRP neurosurgery cases in comparison with cases with no SRP~     rehearsal. This is a single site study with one enrolling site. This study will include a~     total of 40 cases 20 SRP cases and 20 control cases). SRP and control cases will be randomly~     selected according to a predetermined alternating sequence.~   "
112165|NCT02099305|"~     The primary goal of the proposed research is to assess the effectiveness of the Adolescent~     Depression Awareness Program (ADAP), a school-based depression education program, in~     increasing depression literacy and treatment seeking in high school students. The ADAP~     intervention will be carried out in approximately 60 schools with over 15,000 students. The~     following are ADAP Implementation Sites: Baltimore Archdiocese High Schools; New Castle~     County, Delaware; Washtenaw County, Michigan; and York County, Pennsylvania.~   "
112166|NCT02099292|"~     The investigator prospectively evaluated the combination of Rituximab and Dexa-BEAM~     (dexamethasone, carmustine, etoposide, cytarabine, melphalan) followed by high dose therapy~     in patients with relapsed/refractory aggressive and indolent lymphoma.~   "
112167|NCT02099279|"~     Chronic obstructive lung disease (COPD) is a major cause of morbidity and mortality, and is a~     major reason for ICU admission. Cardiac function is often impaired in this disease but its~     association with clinical outcome has not been fully established. The study aims to~     investigate the association between cardiac dysfunction and clinclial outcomes.~   "
112168|NCT02099266|"~     By doing this study, researchers hope to learn the following:~        -  If providing hyperbaric oxygen (HBO) therapy prior to an umbilical cord blood (UBC)~          transplant will help to improve the homing process~        -  The safety of HBO administration in the setting of the UBC transplant~        -  The effects of HBO therapy on the engraftment process~   "
112169|NCT02099253|"~     Dexmedetomidine(DEX) is a novel , highly selective α2 adrenergic receptor agonists , and its~     selectivity for α2 receptor is 1600 times higher than α1.It also could provide dose-dependent~     sedation , analgesia , anti-anxiety and inhibition of sympathetic nerves and other effects~     .At earlier time It was approved by the FDA only for short-time sedation during mechanical~     ventilation of adult patients (<24h) in ICU. Because of its minimal impact on the respiratory~     , currently it was more and more widely used to sedate patients undergoing regional~     anesthesia.Many anesthetic pharmacokinetics and pharmacodynamics are often affected by age~     and gender,such as the drug sensitivity of propofol and remifentanil is increased with~     age,while the current study also demonstrated that gender may influence the sedate efficacy~     of propofol and the sensitivity of muscle loose of rocuronium. Current studies with regard to~     the effects of age and gender on dexmedetomidine pharmacodynamic are rare. The study is aim~     to explore the right DEX dose of different Age of patients to produce suitable~     sedation.Dexmedetomidine be used in patients with combined spinal and epidural anesthesia for~     sedation,which is monitored by the BIS,during the operation.The relation between BIS values~     and the depth of sedation for patients is also investigated.~   "
112245|NCT02098265|"~     The purpose of this research is to determine if two non-invasive brain stimulation~     techniques, muscle stimulation of the arm and neuro-stimulation through the tongue, can~     increase the extent of stroke recovery.~   "
112170|NCT02099240|"~     Based on the current literature, investigators hypothesize that patients with osteomyelitis~     who are treated with the standard approach of intravenous antibiotics for the full duration~     of therapy will have the same clinical outcomes as patients treated with the experimental~     approach of intravenous antibiotics with early switch to oral antibiotics.~      The primary objective of this study is to compare patients with osteomyelitis treated with~     the standard approach of intravenous antibiotics for the full duration of therapy versus~     patients treated with intravenous antibiotics with an early switch to oral antibiotics in~     relation to clinical outcomes at 12 months after discontinuation of antibiotic therapy.~     Secondary objectives of the study include the evaluation of adverse events related to the use~     of antibiotics as well as the cost of care evaluated from the hospital perspective.~   "
112171|NCT02099227|"~     To examine the effect of Point-of-Care Ultrasound (POCUS) management guidance on pediatric~     skin and soft tissue infections treatment failure rate, as well as emergency department~     process outcome.~   "
112172|NCT02099214|"~     Hereditary haemochromatosis (HHC) is a frequent disease in Brittany (5 to 7‰), responsible~     first for biological disorder in blood iron parameters and minor clinical disorders, before~     evolving to potential life-threatening consequences such as diabetes, liver cirrhosis and~     congestive heart failure.~      The improvement of screening and treatments made those severe affections rare enough not to~     evaluate myocardial iron overload a systematic part of the starting check-up. Nonetheless~     this myocardial iron overload might have severe implications on cardiac function on a long~     term basis.~      A single trial was conducted on limited number of patients with 1.5 Tesla MRI, which showed a~     myocardial iron overload (defined by a myocardium T2* value <20ms) in 19% of the subjects.~      The main objective of this study is to precisely estimate cardiac iron overload in treatment~     naive patients with newly diagnosed HFE hereditary haemochromatosis with a 3 Tesla MRI, more~     sensitive than the 1.5 Tesla one, in order to later appreciate its correlation with cardiac~     morbidity in HHC.~   "
112173|NCT02099201|"~     This is a single-center, double-blind, parallel-group, randomized, placebo-controlled,~     multiple-ascending oral dose study to investigate the safety, tolerability, pharmacokinetics,~     and pharmacodynamics of ACT-389949 in healthy subjects.~      Part A of the study will evaluate the safety and tolerability following once a day oral~     dosing of ACT-389949 for 9 days and investigate ACT-389949 pharmacokinetics and~     pharmacodynamics.~      Part B of the study will evaluate the safety and tolerability of ACT-389949 following a~     maximum of two different oral dosing regimens: ACT-389949 given either every 3 days for 13~     days or every 2 days for 9 days (5 doses for each regimen).~      Part C of the study, if required, will provide additional information to that obtained from~     Parts A and B in terms of safety, tolerability, pharmacokinetics, and pharmacodynamics of~     ACT-389949.~   "
112174|NCT02099188|"~     Sinonasal tumors are rare diseases, as they account for the 0.2 % - 0.8 % of all tumors. For~     patients with inoperable tumors, the prognosis is poor and the current therapy is a~     combined-modality treatment that is both more effective and associated with less morbidity.~      This study proposes innovative integration of multiple modality of treatment modulated by~     histology, molecular profile and response to induction CT.~   "
112175|NCT02099175|"~     Sinonasal tumors are rare diseases, so no standard treatment for such aggressive tumors has~     been reported, given rarity, absence of prospective study and heterogeneity of histologies~     and stages of diseases. This study proposes innovative integration of multiple modality of~     treatment depending by histology, molecular profile and response to induction CT. Moreover,~     such strategies allows the use of latest technology with greater biological effectiveness and~     reduction of toxicities.~   "
112176|NCT02099162|"~     Optical coherence tomography (OCT) has been recently studied for evaluation of coronary~     stenting. Because of high resolutions, several reports have shown that OCT is appropriate for~     evaluating neointimal tissue after coronary stent implantation. Also, the strut coverage and~     the characterization of neointimal tissue can be accurately evaluated. Furthermore,~     OCT-defined coverage of a stent strut was proposed to be related with clinical safety in~     drug-eluting stents-treated patients. Therefore, we will evaluate the appropriateness of~     currently using coronary stents (e.g. Sirolimus eluting stent, Paclitaxel-eluting stent,~     Zotarolimus-eluting stent, Everolimus-eluting stent, Biolimus eluting stent, EPC(endothelial~     progenitor cell) Capture stent, etc) based on the findings of OCT. Additionally, we will~     evaluate neointimal hyperplasia, malposition or strut coverage to decide the differences in~     the stent characteristics, the duration of antiplatelet use, and the differences according to~     the clinical presentations.~   "
112177|NCT02099149|"~     Compare anticapsular antibody levels against Group B Streptococcus at delivery in mothers and~     their infants who develop disease versus those who do not. Use this comparison to establish~     antibody levels associated with reductions in risk of GBS disease in infants aged less than~     90 days.~   "
112178|NCT02099136|"~     This randomized clinical trial studies if celecoxib will prevent the damaging effects of~     sunburn in healthy volunteers. Exposure to ultraviolet light can induce erythema, sunburn or~     skin redness caused by inflammation. Celecoxib may reduce skin damage by blocking enzymes~     associated with sunburn in healthy volunteers. Studying samples of skin in the laboratory~     from patients receiving ultraviolet-radiation before and after celecoxib treatment may help~     doctors learn more about the effects celecoxib has on cells.~   "
112179|NCT02099123|"~     The STAREE study will examine whether treatment with statin (atorvastatin 40mg) compared with~     placebo will prolong overall survival or disability free survival amongst healthy elderly~     people (≥70 years).~   "
112180|NCT02099110|"~     This is a study of co-administration of ertugliflozin (MK-8835/PF-04971729) and sitagliptin~     given together or alone along with metformin in participants with Type 2 diabetes mellitus~     (T2DM) and inadequate glycemic control on metformin monotherapy. The primary hypothesis of~     this study is that ertugliflozin 15 mg daily plus sitagliptin 100 mg daily provides greater~     hemoglobin A1C (A1C)-lowering compared with sitagliptin 100 mg daily alone.~   "
112181|NCT02099097|"~     The purpose of this study is to develop and test a web-based game called Quit It that is~     designed to help smokers who have quit smoking cope with any smoking urges they may have. The~     purpose of the game is to help people quit and stop people from smoking again.~   "
114586|NCT02067624|"~     The purpose of this study was to investigate the effect of Thai massage on pressure pain~     threshold, pain intensity, wrist range of motion, grip strength and patient satisfaction in~     patients with wrist extensor muscles latent Myofascial trigger points.~   "
112182|NCT02099084|"~     This research study was done to see what the effects are of Teduglutide on people with short~     bowel syndrome (SBS). Teduglutide is a synthetic medication administered as an injection,~     which has shown to increase intestinal blood flow, inhibit gastric secretion, increase growth~     of intestinal cells and increase absorption of nutrients. Teduglutide has demonstrated to~     decrease Total Parenteral Nutrition (TPN) requirements by 20%. Teduglutide is approved by the~     Food and Drug Administration (FDA) for the treatment of adult patients with Short Bowel~     Syndrome (SBS) who are dependent on parenteral support.~      The primary hypotheses for this study were 1) that Teduglutide significantly increases the~     gastric emptying half time of solids when compared to placebo. 2) Teduglutide will~     significantly decrease the intestinal permeability and urinary excretion of lactulose when~     compared to placebo.~   "
112183|NCT02099071|"~     This is a prospective, single-center, double-blind, randomized, placebo-controlled, ascending~     single oral dose and food interaction Phase 1 study. It will evaluate the safety,~     tolerability, pharmacokinetics and pharmacodynamics of ascending single oral doses of~     ACT-389949 in healthy male subjects. It will also investigate the effect of food on the~     pharmacokinetics, safety, and tolerability of a single dose of ACT-389949.~   "
112184|NCT02099058|"~     This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and~     preliminary efficacy of ABBV-399 in subjects with advanced solid tumors.~   "
112185|NCT02099045|"~     Background: It is well known that emergency physicians can conduct ultrasound examinations as~     a supplement to initial physical examination. No previous studies have been conducted to~     evaluate the total findings with ultrasound on a broad unselected group of patients in the~     Emergency Department.~      Aim: We aim to identify the pathology found in an unselected cohort of patients in a Rural~     Emergency Department. Secondarily we aim to quantify the changes done in treatment as a~     result of the ultrasound examination performed bedside in the Emergency Department.~      Hypothesis: Supplemental ultrasonographical examination will change diagnostics and treatment~     in 10 % of an unselected cohort of patients in the Emergency Department.~      Method: We will perform a structured ultrasound examination of 406 patients on an unselected~     cohort in the emergency department. All patients age 18 years and above presenting in the~     emergency department will be included in the study. Patients unwilling to give informed~     consent will be excluded from the study. Patients will be excluded if the ultrasonographic~     examination cannot be performed within the first two hours after initial contact with the~     treating physician. The study will be conducted in two substudies. Sub study 1 including all~     patient legally competent to give informed consent. Sub study 2 including all legally~     incompetent patients who cannot give informed consent due to acute illness. These patients~     will be included in the study under the rules of emergency research.~      After including the patients we will ask the treating physician a series of binary questions~     regarding diagnosis and treatment plan.~      Outcome: Primary outcome is the pathology found by ultrasound in the department. Secondary~     outcome will be the changes in diagnosis or treatment plan. Pathology and changes in~     diagnosis/treatment will be stratified according to initial complaint, triage level, age and~     other factors. This has never been done on unselected patients in the Emergency Department.~      Ethical considerations and adverse effects: Ultrasound transmits high frequency waves into~     the tissue, which is reflected to the ultrasound probe. The time and magnitude of the~     returning sound waves are interpreted into picture on the screen. No adverse effects have~     been reported on the basis of the sound waves transmitted through the tissue.~      Some patients might experience discomfort due to the sticky sensation from the application of~     ultrasound gel. Others might experience discomfort from the pressure applied to the probe~     under the imaging. Adverse effects, which we are not aware of, may exist. However, clinical~     ultrasound has existed since the 1950'ies and new adverse effects are unlikely.~      Publication: All results will be published in international peer-review journals. Also in the~     event of inconclusive results.~   "
112186|NCT02099032|"~     Polar lipids have a specific chemical structure: they are an essential component of human~     cell membranes, play a major role in the nervous system and also influence the metabolic~     pathways including the cholesterol metabolism.~      Polar lipids are used in food-processing industry for their emulsification properties. The~     most famous emulsifier is soya lecithin but milk also naturally contains natural emulsifiers~     such as polar lipids.~      The purpose of this research is to study plasma cholesterol variation after daily intake of~     milk polar lipids-fortified cheese products. The volunteers will have to consume 100 g of~     cheese product during four weeks instead of their usual cheese products.~      It is a bi-centric study with a centre in LYON (Centre de Recherche en Nutrition Humaine~     Rhône-Alpes) and CLERMONT-FERRAND (Centre de Recherche en Nutrition Humaine Auvergne).~   "
112187|NCT02099019|"~     As the prospective, observational, cross-sectional study, the accuracy of CT~     angiography-based therapeutic decision-making for revascularization will be evaluated. The~     primary objective of this study is to evaluate the accuracy of CT angiography-based~     therapeutic decision-making for revascularization prior to conventional angiography whether~     CT angiography is an accurate non-invasive technique to determine the most appropriate~     therapeutic strategies.~   "
112188|NCT02099006|"~     This study is testing drugs not previously used topically for the treatment of vulvodynia, a~     common genital pain syndrome. It is hoped that one of these drugs will improve vaginal~     entryway pain with touch, daily pain scores and sexual functioning.~   "
112189|NCT02098993|"~     The purpose of this study is to determine the feasibility of performing a larger multicenter~     phase III trial to assess the effects of unfractionated heparin (UFH) in acute chest syndrome~     (ACS). Prespecified feasibility criteria consists of the ability to enroll potential study~     participants, which includes the timely notification of hospitalized patients with ACS, the~     capacity to consent eligible individuals, and the ability to appropriately randomize eligible~     patients within 24 hours of diagnosis. Additional feasibility objectives involve ensuring~     appropriate eligibility criteria, proper administration of the study drug, and the ability to~     completely and accurately collect clinical data of interest. The final aim of our pilot study~     is to provide preliminary data, with respect to treatment effect and variance, to allow~     sample size calculation in a larger trial given the lack of data available to help guide this~     process. The investigators hypothesize that the use of UFH in ACS will result in a decrease~     in the duration of hospitalization and improve other clinical outcomes, such as the duration~     of hypoxemia and duration of moderate to severe pain.~   "
112190|NCT02098980|"~     There is an association between elevated Type II Diabetes Mellitus (T2DM) risk and low serum~     levels of vitamin D. It is important to examine whether Vitamin D can enhance oral glucose~     tolerance in individuals at risk for developing T2DM. As such, the hypothesis suggested is~     that Vitamin D supplementation (4,000 IU/day) for 24 weeks in pre-diabetic individuals will~     decrease insulin resistance and the associated metabolic indices linked to the later~     development of T2DM.~   "
112239|NCT02098343|"~     The purpose of this study is to make a preliminary assessment of the efficacy of a combined~     APR-246 and carboplatin/PLD chemotherapy regimen, compared with carboplatin/PLD chemotherapy~     regimen alone, in patients with platinum sensitive recurrent high grade serous ovarian cancer~     (HGSOC) with mutated p53. In addition, the study aims to assess the safety profile of the~     combined APR-246 and carboplatin/PLD chemotherapy regimen compared with carboplatin/PLD~     chemotherapy regimen alone, to evaluate potential biomarkers, and to assess the biological~     activity in tumor and surrogate tissues. The trial will enroll up to a maximum of 400~     patients.~   "
112240|NCT02098330|"~     The purpose of this study was to compare the treatment effectiveness of steroid therapy for~     vestibular neuritis by using video head impulse test.~   "
112191|NCT02098967|"~     This open label, Phase I study of RO6839921 is a dose-escalation study with two arms. Prior~     to investigations in either arm, patients in a single cohort, Cohort 0, will receive~     non-escalating, intravenous (IV) doses of RO6839921 daily on Days 1-5 of a 28-day cycle.~     Interim PK and safety data from this cohort will be evaluated before initiating~     dose-escalation.~      In arm A, RO6839921 will be given to patients with advanced solid tumor malignancies. In Arm~     B, RO6839921 will be given to patients with relapsed/refractory acute myeloid leukemia (AML).~     The arms will escalate independently. Escalation will begin in solid tumor patients (Arm A)~     in single patient cohorts, using a new Continual Reassessment Method (n-CRM). Escalation for~     AML patients will be initiated at or below the dose level that causes >/= Grade 2 hematologic~     side effects in Arm A. Escalation in AML patients will follow a rolling 6 design.~      In both arms, RO6839921 will be administered by IV infusion on Days 1-5 of 28-day cycles.~      There will be no intrapatient dose escalation. All patients may be treated until disease~     progression/relapse or unacceptable toxicity.~   "
112192|NCT02098954|"~     Numerous evidences verified that erlotinib could dramatically improve the PFS and OS of~     non-small cell lung cancers who harbor EGFR sensitive mutations, however, primary or~     secondary resistance will be developed after TKI treatment, doctors do plenty of researches~     to overcome TKI resistance. FAST ACT-2 study present that, first line erlotinib combined with~     chemotherapy could improved mOS to more than 30 months in NSCLCs who harbor EGFR sensitive~     mutations, several study shows that sensitive mutations still exist after TKI resistance,~     because of the next generation TKIs(such as BIBW2992) are not avaliable at present, agents~     for met amplification(such as Crizotinib) are so expensive that many Chinese patients could~     not support. Thus, the investigators hypothesis that, after first line TKI treatment, the~     patients who developed TKI resistance could still benefit from second line TKI combined with~     chemotherapy.~   "
112193|NCT02098941|"~     The Objective of this study is to compare 2-year retention rate of topiramate, levetiracetam~     and oxcarbazepine in a long term epilepsy treatment.~   "
112194|NCT02098928|"~     Main objective: to compare the effects of hand-acupuncture and electro-acupuncture~     stimulation on the baking heat symptoms of menopause Secondary objective: to evaluate the~     safety and acceptability of hand acupuncture and electroacupuncture stimulation~   "
112195|NCT02098915|"~     Infants with gastroschisis typically have poor intestinal motility for the first weeks to~     months after birth. Prokinetic agents are often used in these infants to improve intestinal~     motility in an attempt to quicken the attainment of enteric feeds. However, the evidence to~     support this practice remains weak. Investigators hypothesize that a prokinetic agent given~     intravenously (infused into a vein) may be effective in improving gut motility in children~     with gastroschisis.~   "
112196|NCT02098902|"~     The purpose of this study is to test the effect of a novel six-month behavioral program to~     reduce sugar-sweetened beverage consumption among preschoolers and their mothers. The~     behavioral intervention tested will be delivered via a mobile-based website, text messages~     and email in addition to one face-to-face group meeting. The intervention will be compared to~     a waitlist control group. Participants will be 42 overweight/obese mothers and their children~     ages 3-5 living in the Chapel Hill/Raleigh/Durham area. Sugar-sweetened beverage consumption~     and weight in both children and mothers will be measured at three- and six-months~     post-randomization. It is hypothesized that children randomized to the intervention will have~     a greater reduction in sugar-sweetened beverage consumption at 6 months compared to children~     randomized to the control group.~   "
112197|NCT02098889|"~     Although Hyoscine N butyl bromide (HBB) is used liberally to facilitate cervical dilatation,~     there is little and inconclusive data about its efficacy. The aim of this study was to~     determine the efficacy and safety of HBB on the augmentation of labor.420 of total 1640~     pregnant women admitted to the investigators clinic (Sisli Ethal Training and Research~     Hospital, Obstetrics and Gynecology Department Obstetrics Service ) between 37-41 gestational~     weeks, active phase (cervical dilatation: 4 cm, cervical effacement: %50 or more) of~     spontaneous labor with vertex presentation enrolled to study. 382 of them were included in~     this study. Patients were randomized to receive intravenously(IV) either 20 mg/ml HBB or a~     similar amount of placebo (1 ml 0.9% NaCl) at the beginning of the active phase of labor. The~     medications applied as single dose. The time elapsed until the second stage of labor, second~     stage and third stage were measured.~   "
112198|NCT02098876|"~     Stents are metallic tubular supports placed inside a blood vessel to relieve an obstruction~     and restore blood flow to the heart muscle. Stents could also be coated with a drug~     (drug-eluting stents - DES) that improves local healing and inhibits growth of scar tissue~     within the vessel that otherwise could lead to re-narrowing. This study will evaluate the~     effects of 2 FDA-approved metallic stents with different designs that may have important~     effects on regional plaque response and blood flow dynamics immediately after stent~     deployment and stent healing at 12 months follow up.~   "
112199|NCT02098863|"~     Despite the important work of previous sickle cell disease (SCD) cohort studies, there remain~     many understudied areas that require investigation. An important knowledge deficit is the~     slow but progressive process of chronic end-organ dysfunction. The majority of organ~     dysfunction becomes apparent in the young adult years, but comprehensive assessment of adults~     and understanding of predictors of adulthood organ dysfunction are insufficient. Similarly,~     the role of disease-modifying therapies, such as hydroxyurea, in preventing organ dysfunction~     later in life is not clear. Extended follow-up of patients through the transition into~     adulthood is imperative to understand the long-term implications of pediatric sickle cell~     care.~      This observational study will collect data in a systematic fashion at participants' regular~     clinic visits to answer the objectives described below.~      In addition to primary study objectives, SCCRIP participants will be eligible to participate~     in a sub-study, which will investigate genetically determined responses to Hydroxyurea (HU)~     via a pharmacokinetic study (PK). This one time study will involve blood collection at timed~     intervals proceeding a dose of HU. Defining the basis for this inter-individual variability~     will allow the identification of poor HU responders prior to initiation of therapy and the~     seeking of alternative treatments which seek to optimize disease treatment by accounting for~     individual variability in genes, environment, and lifestyle.~   "
112200|NCT02098850|"~     The purpose of this evaluation is to record the management and outcome of adults with~     S.aureus bacteraemia (SAB) across multiple European, Asian and North American sites and to~     identify key quality indicators associated with improved outcome.~   "
112201|NCT02098837|"~     The purpose of the study is to investigate the benefits of switching away from a kind of drug~     called a boosted protease inhibitor (PI) to a new drug called dolutegravir on patients'~     cardiovascular health (the health of their hearts). Patients are currently taking two other~     anti-HIV drugs, called nucleoside reverse transcriptase inhibitors (NRTIs), with their~     boosted PIs; these NRTIs will not be changed throughout the study. In order to compare the~     boosted PI and dolutegravir more accurately, half of study participants will be switched to~     dolutegravir immediately, and the other half will be switched after 48 weeks of continuing on~     the boosted PI.~      Boosted PIs are associated with increased heart and circulation risk so it is hoped that~     switching from a boosted PI to dolutegravir will improve the health of the patients' hearts.~     Dolutegravir is a drug for HIV treatment which has been approved for use in HIV patients in~     the US and Europe. Clinical trials using dolutegravir have found that it is effective at~     suppressing the HIV virus, and it is at least as effective as the other drugs.~      This study will also investigate the safety (in terms of other side effects and the routine~     blood tests which the investigators ordinarily use to monitor patients' treatment) and~     monitor effectiveness, patients' viral load and CD4 counts, when patients switch treatment~     from a boosted PI to dolutegravir. Viral load is the amount of the HIV virus they have in~     their blood, and CD4 count is a measure of a type of cell that is in their immune system. We~     also aim to improve patients' cardiovascular health in general by providing them with~     information on how to live a healthy lifestyle (eg improving their diet, stopping smoking~     etc).~   "
112202|NCT02098824|"~     Single center threeway double blind cross over trial investigating the pharmacological~     responsivity in patients with VCI using a challenge aimed at the monoaminergic and~     cholinergic neuronal systems~   "
112203|NCT02098811|"~     The purpose of this study is to evaluate and compare the safety and efficacy of a~     non-invasive 1064nm laser and 940nm diode, for the disruption of subcutaneous adipose tissue~     and skin tightening.~   "
112204|NCT02098798|"~     We propose a randomized controlled study to determine the detection rates of neoplasia with~     high definition colonoscopy alone, high definition dye spraying chromoendoscopy or High~     definition iSCAN virtual chromoendoscopy in patients with long standing colitis (8 years from~     diagnosis except primary sclerosing cholangitis when surveillance starts at diagnosis) CD or~     UC.~      We hypothesized that these novel endoscopic techniques using High definition colonoscopy with~     virtual chromoendoscopy -iScan 2 and 3 may be superior to high definition colonoscopy alone~     and similar to using dye spraying chromoendoscopy for detection of dysplasia and neoplasia in~     patients with long standing IBD.~      We will aim to demonstrate if we can avoid dye spraying during the procedure and save expense~     and considerable time.~      In addition, we can hope to produce evidence and inform the way in which we perform~     surveillance colonoscopy especially without large number of multiple random biopsies but only~     few targeted smart and intelligent biopsies using high definition colonoscopy with iSCAN~     technique as is already the European practice in several centres.~   "
112205|NCT02098785|"~     Worldwide, liver related morbidity and mortality continue to rise. It is the 5th commonest~     cause of death in the UK. Liver damage consists of two main components - a) damage to the~     cells of the liver, called hepatocytes, meaning the liver cannot function properly leading to~     jaundice (yellow appearance of the skin and/or eyes) and liver failure and b) scarring of the~     liver, called Cirrhosis, leading to impaired function and inadequate blood flow through the~     liver with potential to develop into cancer. Manifestations of this state include ascites~     (fluid in the tummy) and varices (swollen blood vessels in the food pipe). Liver transplant~     is currently the only curative treatment for end stage chronic liver disease. Unfortunately~     its high demand has not been matched by an equivalent rise in liver donations and even when a~     transplant has occurred there are numerous lifestyle effects such as immunosuppression and~     kidney impairment thus outcome remains poor for many patients. Coffee has been shown to have~     mortality benefit in humans and drinking two to three cups a day was associated with a 40%~     reduced risk of developing cirrhosis, particularly alcohol related; and higher the more cups~     consumed. Previous work has demonstrated coffee reduces the level of fibrosis in the liver by~     interrupting signalling pathways, blocking the effects of special products, called cytokines,~     and reducing accumulation of iron. The investigators' hypothesis is that given the potential~     for caffeine to be used as a treatment in SSAO activity associated diseases it is important~     to see if the activity of SSAO can be blocked in healthy humans too. The Investigators' aim~     to examine the effect of caffeine on circulating VAP-1 levels in large numbers of healthy~     volunteers to assess its potential as an attractive therapeutic target in view of its low~     toxicity and widespread availability.~   "
112206|NCT02098772|"~     The objective of this investigation is to compare the cardioprotective effects and safety of~     two cardioplegic solutions, HTK Cardioplegic Solution (Custodiol) and Custodiol-N in patients~     undergoing aortic valve surgery. The study design is a prospective, double blind,~     multicenter, randomized, Phase III comparison study intended to demonstrate superiority in~     surgical outcome between Custodiol and Custodiol-N as determined by CK-MB peak value 4-24~     hours after opening of the aortic cross-clamp (primary endpoint), catecholamine requirement~     (cumulative dose) and cardiac Troponin T, occurrence of comorbid events postoperatively~     (e.g., myocardial infarction).~   "
112207|NCT02098759|"~     The primary objective of clinical part of EPISTOP project is to identify the clinical and~     molecular biomarkers of epileptogenesis in a prospective clinical study of patients with TSC.~      Secondary objective of the clinical part of EPISTOP is to compare the effects of standard~     antiepileptic treatment in patients diagnosed as having epilepsy after clinical seizures vs~     after electroencephalographic epileptiform discharges, in a randomized trial in TSC patients.~   "
112208|NCT02098746|"~     The purpose of this study is to evaluate the safety and efficacy of long-term use of~     pioglitazone/glimepiride combination tablets (Sonias Combination Tablets LD) in patients with~     type 2 diabetes mellitus who respond poorly to pioglitazone hydrochloride monotherapy~     (pioglitazone at 15 mg/day) in the routine clinical setting.~   "
112209|NCT02098733|"~     The purpose of this study is to evaluate the safety and efficacy of long-term use of Sonias~     Combination Tablets in patients with type 2 diabetes mellitus in the routine clinical~     setting.~   "
112210|NCT02098720|"~     This study is designed to evaluate the effect of Conbercept therapy on visual acuity and~     anatomic outcomes and safety observed in subjects with very low vision secondary to wet~     age-related macular degeneration.~   "
112211|NCT02098707|"~     Pharmacotherapy with dopaminergic medications and deep brain stimulation cannot provide~     significant improvements in postural instability in Parkinson's disease, whereas previous~     reports of physical interventions have suggested promising results. The investigators want to~     study the effects of the multidisciplinary intensive rehabilitation treatment (MIRT) on~     balance disorders in Parkinson Disease (PD).~   "
112213|NCT02098681|"~     Context: Chest wall deformities in children are relatively common. One such deformity, known~     as Pectus Excavatum (PE), involves a concavity of the chest and is the most frequent of these~     abnormalities - present in approximately 1 out of every 400-1000 births. This deformity is~     often a cosmetic problem for affected individuals. When severe, PE can also be associated~     with cardiopulmonary compromise.~      Treatment of PE involves surgical correction. There are several potential methods for~     correcting PE. In the past the most common repair involved an open procedure which involves~     excision and reshaping of the ribcage. More recently a minimally invasive procedure has been~     adopted involving the placement of a stainless steel or titanium bar underneath the sternum~     to reshape the chest wall. This procedure, commonly known as the Nuss procedure, carries with~     it significant post-operative pain management problems. In fact, the pain issues after Nuss~     procedure may be more significant than after open repair. The quality of postoperative pain~     control in these cases has been shown to affect several measurable objective outcomes during~     hospitalization including capacity for deep breathing, early mobilization, ambulation, and~     length of hospital stay.~      Epidural analgesia (EA) has been one of the standard methods for managing pain in the early~     postoperative period after PE repair. Unfortunately severe pain may persist after the removal~     of an epidural catheter resulting in a difficult transition period just prior to discharge~     from the hospital. In addition reports of neurological injury after epidural analgesia for~     Nuss procedures have appeared. In light of these issues, many institutions have opted for~     alternative methods of pain control including peripheral nerve blocks, patient controlled~     analgesia, and wound catheters.~      There remains significant debate as to which pain control methodology is best. There is~     little consistent data available on pain control or outcomes that occur after EA is stopped.~     Moreover there is reluctance in any one institution to trial or randomize patients to a~     variety of treatment modalities. For all of these reasons, investigators are proposing~     participation in a multi-institutional data sharing project concerning the repair of EA in~     which participating centers will collaborate to better understand the outcomes of~     perioperative care for patients undergoing correction of this problem.~   "
112214|NCT02098668|"~     Development of a bio-mathematical model of the human female cycle~   "
112215|NCT02098655|"~     Objective: To analyze different parameters in patients with Parkinson's Disease (PD) obtained~     through the use of a stabilometric platform and compare them with those of a control~     population. To interpret the data in order to find some postural instability indicators that~     can become useful to build a rehabilitation strategy for balance disorders in PD.~   "
112216|NCT02098642|"~     Parkinson's disease is a degenerative disorder of the central nervous system. The motor~     symptoms of Parkinson's disease result from the death of dopamine-generating cells in the~     substantia nigra, a region of the midbrain; the cause of this cell death is unknown. Early in~     the course of the disease, the most obvious symptoms are movement-related; these include~     shaking, rigidity, slowness of movement and difficulty with walking and gait. A~     multidisciplinary intensive rehabilitation treatment (MIRT) is able to improve different~     parameters in PD that are poorly responsive to dopaminergic therapy. In this study, we aim to~     understand whether the passive mobilization of the metatarsophalangeal joint of the hallux~     determines an increase in the joint range in this district, allowing to improve, at least,~     the gait.~   "
112217|NCT02098629|"~     Heart attack is the leading cause of death in the developed world. Following heart attack,~     re-establishing blood flow in a clogged heart vessel using percutaneous coronary intervention~     (PCI) is the standard of care. This therapy is called reperfusion therapy. Unfortunately,~     reperfusion therapy itself poses additional heart muscle damaging effect, a process called~     reperfusion injury. Excessive reperfusion injury can offset the net benefit of heart vessel~     blood flow restoration in patients with heart attacks. For those heart attack survivors,~     massive reperfusion injury can contribute to heart failure which carries high risk for death~     and long-term disabilities. To date, there is no drug available that can reduce reperfusion~     injury in heart attack patients.~      Our group has demonstrated in a preclinical study that combining two available medications~     (milrinone and esmolol) when given right before the onset of reperfusion therapy greatly~     reduces heart muscle damage in an animal heart attack model. Furthermore, in a clinical~     safety, we demonstrated that combination therapy with milrinone and esmolol is safe in~     patients with heart attack undergoing PCI. If the heart-protective effect observed in our~     preclinical study can be replicated in human subjects, this proposed therapy will become the~     first of this kind to treat clinical reperfusion injury.~      The present trial is a proof-of-concept study to determine whether the combination~     administration of milrinone and esmolol at the onset of reperfusion reduces the heart muscle~     damage in heart attack patients who receive reperfusion therapy with PCI.~   "
112218|NCT02098616|"~     The purpose of this study is to determine whether treatment with~     Daclatasvir/Asunaprevir/BMS-791325, with or without ribavirin, for 8, 6, or 4 weeks is~     feasible for the treatment of genotype 1a chronic hepatitis C in patients without cirrhosis.~   "
112219|NCT02098603|"~     More than 530,000 individuals work as US Correctional Officers (COs) responsible for~     overseeing the approximately 1.6 million offenders who are incarcerated at any given time in~     the United States. Prison work is regarded as one of the most difficult occupations with CO's~     having one of the highest nonfatal injury rates of all U.S. occupations. The few studies done~     on CO's show high levels of stress, cardiovascular disease, high job burnout, increased sick~     leave rates and absenteeism, and decreased quality of life leading to premature~     illness/injury and high employer healthcare costs. Many of these conditions could be~     prevented by specific training activities and healthier lifestyles. The investigators wish to~     test a worksite-based, health promotion curriculum in COs with the overall hypothesis that~     the program will improve health and decrease injuries. The program proposed would be the~     first occupational intervention to improve the safety, and emotional and physical health of~     those who are charged with the complex task of prison work protecting the investigators~     communities. If successful, this proposal would result in an exportable, practical~     occupational safety and health program applicable for use by local, state, and federal~     correctional facilities.~   "
112241|NCT02098317|"~     Non-alcoholic fatty liver disease (NAFLD) has reached epidemic proportions and is rapidly~     becoming the one of most common causes of chronic liver disease in children. The pathogenesis~     of NAFLD is generally considered the result of a series of liver injuries, commonly referred~     as multi-hit hypothesis. Several studies suggest that inflammatory pathways and oxidative~     stress could be responsible of disease progression.~      The purpose of this interventional study is to evaluate the efficacy and tolerability of~     docosahexaenoic acid (DHA) and Vitamin D in children and adolescents with biopsy-proven~     nonalcoholic fatty liver disease (NAFLD).~   "
112259|NCT02098083|"~     Data collection for this study will be done by clinicians working in inpatient rehabilitation~     units with persons with acute stroke. No interventions are included in this study. It is~     designed to capture trends in current clinical practice for persons with stroke. This data~     will be useful in identifying the most beneficial and effective walking treatments as well as~     most significant patient characteristics that impact recovery for persons acutely after~     stroke. All data collection will take place during the inpatient rehabilitation stay.~   "
112220|NCT02098590|"~     Malaria, a disease caused by the parasite Plasmodium, is one of the world's major infectious~     diseases. With approximately 627.000 deaths a year, it is both a chief cause of morbidity and~     mortality as well as a significant contribution to ongoing poverty in endemic countries.~     Ultimately, the key to malaria control, and hopefully eradication, would be an effective~     vaccine. Though a number of vaccine-candidates have entered the pipeline of pre-clinical and~     clinical development, they have yet to achieve the level of efficacy necessary for effective~     malaria prevention. It has been shown previously that if healthy human volunteers taking~     chloroquine chemoprophylaxis are repeatedly exposed to Plasmodium parasites through the bites~     of infected mosquitoes, they are fully protected against a later challenge infection with a~     'homologous' (genetically similar) Plasmodium parasite. This process is known as~     ChemoProphylaxis and Sporozoites, or CPS-immunization. One of the obstacles to developing an~     effective vaccine is the genetic heterogeneity of malaria parasites. To further consider the~     development of whole-parasite based vaccines against malaria and in order to better~     understand the protective immunity induced by CPS-immunization, it is essential to~     investigate whether heterologous protection against genetically diverse (heterologous) P.~     falciparum clones can be induced.~      This is a single center, randomized, double-blind study to determine whether healthy~     volunteers immunized with P. falciparum NF54 parasites under chloroquine prophylaxis are~     protected against a challenge infection with the genetically distinct NF135.C10 or NF166.C8~     P. falciparum clones.~   "
112221|NCT02098577|"~     The aims of this study is to assess the efficacy of the crossover on balance in Parkinsonian~     patients and compare this results with the results of a control group of patients treated~     with a stabilometric platform.~   "
112222|NCT02098564|"~     Background Patients with the same type of hand injury often reach different functional~     levels. Therefore, it is necessary to investigate what kind of rehabilitation is most~     efficient for each individual patient.~      Research has shown that a person's Sense of Coherence (SOC) affects how he /she deals with~     disease. Furthermore, SOC can help predict final outcomes after orthopedic injuries and~     should therefore; be taken into consideration when planning rehabilitation. It was concluded~     in a study that patients with a weak SOC who have had a hand injury, may benefit from extra~     support to manage their everyday activities in order to reach the same final outcome as~     patients with a strong SOC.~      Purpose To investigate two types of rehabilitation on patients with a hand-related injury~     (joint mobility exercises vs. activity-based training and joint mobility exercises) and to~     investigate whether SOC can be used as an indicator of which patients would benefit from~     activity-based training.~      Hypotheses~        1. Patients with a hand-related injury will benefit from activity-based training in their~          rehabilitation program.~        2. Patients with a weak SOC will achieve the best functional level, if activity-based~          training is included in their rehabilitation program.~        3. Patients with a strong SOC will not achieve a higher functional level, if activity-based~          training is included in their rehabilitation program.~      Study design Randomised control trial. Methods Four-hundred-twenty- patients age 18 years or~     older are included when referred to specialized outpatient occupational therapy after a~     hand-related injury. To ensure sufficient and balanced patient variation in relation to~     pre-rehabilitation sense of coherence, a balanced randomisation principle has been~     implemented.~      Data will be collected through questionnaires. The questionnaires measure SOC (13 items~     version), function (DASH), quality of life (EQ5D) and satisfaction.~      All participants will perform joint mobility exercises which are appropriate for their~     injury. In addition, participants who will be performing activity-based training will train~     with specific meaningful activities which they performed prior to the hand-related injury.~      Clinical relevance The knowledge obtained will be incorporated into the planning of~     occupational therapy rehabilitation services for this patient group, so that the patients~     will receive the most optimal conditions in which to achieve their previous level of function~     after a hand injury.~   "
112223|NCT02098551|"~     Aim of this study is to use the major allergen 1 of birch-tree pollen (Bet v 1, Betula~     verrucosa, synonymous Betula pendula), to investigate the contribution of immunoglobulin E~     (IgE)- versus non-IgE-mediated mechanisms to chronic skin inflammation in atopic dermatitis~     patients.~   "
112224|NCT02098538|"~     Regorafenib is an oral medication that can interfere with cancer cell growth and reduce the~     growth of blood vessels around tumors. This study will help find out if regorafenib is a~     useful drug for treating patients with adenoid cystic carcinomas. Regorafenib has been~     approved by the Food and Drug Administration (FDA) for use in other cancers, but remains an~     experimental drug that has not yet been approved for use in adenoid cystic carcinoma.~      In this study, the patient will initially be treated with a dose of regorafenib that is lower~     than what the FDA approved for other cancers in an attempt to decrease the risk of side~     effects. It is possible that this lower starting dose may not be as effective as the higher~     FDA approved dose. If the patient does well with the lower dose for at least a month on~     treatment, the physician may consider increasing the dose to the FDA approved dose.~   "
112225|NCT02098525|"~     Cryptococcal meningitis is one of the most common central nervous system infections among~     HIV-infected patients. The outcome is generally severe. This study aims to determine~     long-term survival rate among HIV-infected CM patients in the era of antiretroviral therapy~     (ART). The secondary objectives are to clarify outcomes of CM and determine prognostic~     factors.~   "
112226|NCT02098512|"~     Patients with relapsed or refractory Hodgkin Lymphoma who are CD30+ will receive a standard~     of care reduced intensity regimen and an allogeneic stem cell transplant (from another~     person, related or unrelated). Following recovery, patients will receive a medication called~     Brentuximab Vendotin which is targeted against CD30+ cells. The study hypothesis is that this~     treatment will be safe and well tolerated in children and young adults.~   "
112227|NCT02098499|"~     Haloperidol is known to be a safe alternative medication to control difficult pain, and has~     been shown effective when compared to placebo for controlling headaches. Investigators~     hypothesized that the combination of haloperidol and diphenhydramine would be a useful~     medication choice for migraine headache patients in the emergency department in comparison to~     a common migraine treatment regimen of metoclopramide and diphenhydramine.~   "
112242|NCT02098304|"~     This is a prospective, multi-centre, post-approval clinical study to assess the safety and~     the performance of the Calcivis Caries Activity Imaging System in aiding the identification~     of active caries lesions on the occlusal surfaces of human teeth. Following the~     identification of potential caries lesions by oral examination under ICDAS (International~     Caries Detection and Assessment System) guidelines, a disclosing solution will be applied~     which will cause areas of active demineralization (loss of calcium ions) to luminesce - these~     will be captured with an intra-oral camera to produce mapping images of the tooth surface.~     For the purposes of this study the presence / absence of luminescence will be used as an~     indicator of lesion activity / inactivity.~      The study will be deemed a success if the level of agreement between elevated luminescence~     with the Calcivis System, and areas of expected lesion activity as rated by the Investigators~     ICDAS staging, is above 70%, is not due to chance and correlates well with published data on~     active non-cavitated lesions in molars at various stages of eruption.~   "
112243|NCT02098291|"~     This study was designed to determine the effect of jaundice on the ability of G17DT to~     generate antibodies before and after treatment of biliary obstruction due to advanced~     pancreatic cancer.~   "
112228|NCT02098486|"~     Background and aims: The use of prophylactic antibiotics before endoscopic retrograde~     cholangiopancreatography (ERCP) is recommended by all major international gastroenterological~     societies, especially in the presence of an obstructed biliary system. Their use is intended~     to decrease or eliminate the incidence of complications following the procedure, namely~     cholangitis, cholecystitis, septicemia, and pancreatitis. However, there were a few reports~     concerning the dosage, duration and adopting antibiotics most suitable for this purpose. The~     aim of this prospective comparative study is to compare the occurrence rate of~     post-procedural complications, such as cholangitis, bacteremia and septicemia between~     intravenous moxifloxacin and ceftriaxone for the prophylactic use in patients with bile duct~     obstruction who will undergo therapeutic ERCP procedure.~      Methods: In this prospective study, a total of 160 patients (calculated by IBM SPSS Sample~     Power, version 3.0) with bile duct obstruction due to variable causes (bile duct stones,~     benign or malignant stricture, etc) will be enrolled and randomly allocated to intravenous~     moxifloxacin and ceftriaxone group, respectively (using simple randomization program).~     Intravenous moxifloxacin (400 mg/day, infused more than 60 min) or ceftriaxone (2 g/day,~     diluted in 40 cc of 5% dextrose water, infused more than 30 min) will be given 90 minutes~     before ERCP procedure, and will be given to a patient for more than 3 days if the patient~     develops symptoms and signs of cholangitis or septicemia.~   "
112229|NCT02098473|"~     The purpose of this study is to determine the effective dose(s) of RPC4046 in the treatment~     of Eosinophilic Esophagitis (EoE). This trial consists of two phases: 16 weeks of~     double-blind treatment and 52 weeks of open-label extension.~   "
112230|NCT02098460|"~     To evaluate the effect of concomitant administration of Probucol and Cilostazol (based on~     Atorvastatin treatment) on the atherosclerosis related markers (including the thickness of~     the Achilles tendon) in severe hypercholesterolemia subject, through the observation of the~     thickness of the Achilles tendon, the thickness of mean carotid intima-media, anti-oxidation~     biomarkers and serum lipid profile.~   "
112231|NCT02098447|"~     The purpose of this pilot study is to evaluate the effect of auricular autonomous nervous~     system stimulation on vital parameters of wound healing in diabetics. It is investigated if~     auricular vagal nerve stimulation has an effect on heart rate variability as well as~     peripheral local blood perfusion, and if this effect depends on the health status of the~     study participants (diseased/healthy).~   "
112232|NCT02098434|"~     The study is investigating the impact of progesterone and estrogen on brain areas that are~     involved with stress response and drug craving. The study will involve 40 women who will~     participate in the Montreal Imaging Stress Task (MIST) while undergoing fMRI scanning~     procedures. Half of the women will complete the procedures during the luteal phase of the~     menstrual cycle; the other half will complete procedures during the follicular phase.~     Subjective and physiological measures (cortisol levels) will be used to measure stress and~     craving response. Hypothesis 1A is that all women will exhibit increased craving, stress~     response, salivary cortisol and BNST and limbic nuclei activation in response to the MIST~     task. Hypothesis 1B is that these increased responses will be higher for women in the luteal~     phase than for women in the follicular phase of the menstrual cycle.~   "
112233|NCT02098421|"~     This study is considering current standard oxytocin dosing regimen in combination with Foley~     bulb for cervical ripening is associated with improved outcomes including greater percentage~     of women delivered within or less than 24 hours. The investigators will also assess other~     maternal and neonatal outcomes including risk of infection (i.e. chorioamnionitis), bleeding,~     uterine atony, cesarean delivery and use of regional analgesia.~      Participants will be randomly assigned to one of the 2 arms of the study: use of oxytocin or~     no oxytocin while the Foley bulb is in place. As part of standard of care for inductions,~     Foley bulbs will be placed for all participants. Study participants who are randomly assigned~     to the use of oxytocin will receive oxytocin at the time the Foley bulb is placed. Study~     participants randomly assigned to no oxytocin will receive the oxytocin once the Foley bulb~     is removed.~      After delivery, information will be collected from participant's chart on the outcome of~     pregnancy such as gestational age at delivery, type of delivery (vaginal or cesarean~     section), and baby's outcome (such as birth weight, APGAR scores, and any complications).~   "
112234|NCT02098408|"~     Cognitive deficits are known to be a core feature of schizophrenia and seem to become~     manifest in the prodromal or Ultra-High Risk (UHR) state of psychosis. The cognitive deficits~     are known to pose a critical barrier to functional recovery. Hence it is of vital importance~     to find intervention strategies that can alleviate these cognitive deficits and consequently~     improve daily functioning, and quality of life, as well as the prognosis for UHR-patients.~     The investigators will examine whether:~        -  Cognitive remediation therapy will be superior to standard treatment in improving~          cognitive functioning in UHR- patients (null hypothesis: No difference between the two~          groups).~        -  Cognitive remediation therapy will be superior to standard treatment in improving~          psychosocial functioning and clinical symptoms in UHR-patients (null hypothesis: No~          difference between the two groups).~   "
112235|NCT02098395|"~     This trial is conducted in Africa, Europe and North America. The purpose of the trial is to~     investigate the efficacy and safety of liraglutide adjunct to insulin treatment in type 1~     diabetes.~   "
112236|NCT02098382|"~     Non-interventional prospective data collection designed to evaluate clinical outcome on the~     efficacy of the use of Dilapan-S in the indication of labor pre-induction in women~     with/without a history of Caesarean section. The evaluation will be based on prospective data~     collection in at least four obstetrics centers in the Czech Republic.~   "
112237|NCT02098369|"~     About 1 million individuals in the US have a prescription for supplemental oxygen (O2). Using~     O2 can prolong life and increase quality of life. Patients often do not use their oxygen as~     prescribed, which means that they are not benefiting as much as they could be from this~     therapy. The purpose of this study is to evaluate whether a PEer-Led O2 Infoline for patients~     and CAregivers (PELICAN) will increase adherence to supplemental oxygen prescription and~     improve health in patients with chronic obstructive pulmonary disease (COPD).~   "
112238|NCT02098356|"~     This study will compare hemodialysis treatment with a standard, high-bicarbonate dialysis~     bath versus a lower bicarbonate dialysis bath, and will compare intradialytic acid-base~     changes and overall control of metabolic acidosis with the 2 treatment regimens.~   "
112246|NCT02098252|"~     The objectives of this study and registry are to offer the best management possible for~     patients with brain arteriovenous malformations (AVMs) (ruptured or unruptured) in terms of~     long-term outcomes, despite the presence of uncertainty. Management may include~     interventional therapy (with endovascular procedures, neurosurgery, or radiotherapy, alone or~     in combination) or conservative management.~      The trial has been designed to test a) whether medical management or interventional therapy~     will reduce the risk of death or debilitating stroke (due to hemorrhage or infarction) by an~     absolute magnitude of about 15% (over 10 years) for unruptured AVMs (from 30% to 15%); and,~     b) to test if endovascular treatment can improve the safety and efficacy of surgery or~     radiation therapy by at least 10% (80% to 90%).~      As for the nested trial on the role of embolization in the treatment of Brain AVMs by other~     means: the pre-surgical or pre-radiosurgery embolization of cerebral AVMs can decrease the~     number of treatment failures from 20% to 10%. In addition,embolization of cerebral AVMs can~     be accomplished with an acceptable risk, defined as permanent disabling neurological~     complications of 8%.~   "
112247|NCT02098239|"~     The study was designed to assess the effect of jaundice on the ability of G17DT to generate~     antibodies before and after treatment of biliary obstruction due to advances pancreatic~     cancer.~   "
112248|NCT02098226|"~     The study objective is to confirm that the MBT-CA System identifies medically significant~     bacteria and yeasts from an isolated colony from any sample type processed by the clinical~     laboratory. For this purpose MBT-CA test results will be compared to bi-directional~     sequencing results.~   "
112249|NCT02098213|"~     Assessment of quality of life after Spa therapy (4 ½ months follow-up) in the treatment of~     plaque psoriasis: Spa versus usual care in patients with plaque psoriasis.~   "
112250|NCT02098200|"~     The TriCinch System™ is intended for percutaneous treatment of tricuspid regurgitation.~      It is a percutaneous catheter-based device designed for tricuspid valve repair in order to~     decrease effective cross-sectional area and relieve symptoms in patients with tricuspid valve~     regurgitation.~   "
112251|NCT02098187|"~     The purpose of this early feasibility study was to investigate the pharmacokinetics of~     MP-3180 administered in rising doses and to evaluate the use of the Optical Renal Function~     Monitor (ORFM), an investigational noninvasive fluorescence detection device.~   "
112252|NCT02098174|"~     The purpose of this study was to investigate the pharmacokinetics of MP-3180 (1 µmol/kg)~     compared to the pharmacokinetics of iohexol (5 mL of a 300 mg iodine (I)/mL solution) in~     healthy adult participants. The secondary objective was to evaluate the safety and~     tolerability of MP-3180 in healthy adult participants.~   "
112253|NCT02098161|"~     To goal of this clinical research study is to learn if LCL161 can help to control~     myelofibrosis. The safety of this drug will also be studied.~   "
112254|NCT02098148|"~     The primary purpose of this study is to investigate whether administration of xenon reduces~     symptoms of Obsessive-Compulsive Disorder (OCD). Xenon is a naturally occurring gas that has~     been used in clinical settings both as a general anesthetic agent and as a contrast agent for~     computed tomography (CT) scans. Investigators believe that xenon may be effective in reducing~     symptoms of OCD due to its ability to reduce the activity of a specific brain chemical called~     glutamate, which has been shown to be abnormal in the brains of people with OCD.~      It is important to understand that this study uses a placebo, or inactive, treatment. In this~     study, the placebo treatment is inhalation of room air (instead of xenon). All participants~     will receive both xenon and placebo treatments at some point over the course of the study.~     However, neither the participants nor the study investigators will know which treatment you~     are receiving.~   "
112255|NCT02098135|"~     stroke, spinal cord injury, rehabilitation, home therapy, upper limb, arm, virtual reality,~     interia sensor,~        -  Trial with medical device~   "
112256|NCT02098122|"~     Functional recovery following SCI in adults is limited. Improvements in the quality of life~     of affected persons are associated with the recovery of functions that allow independent~     living, for example use of the arms and hands. Rehabilitative training has been shown to aid~     upper limb recovery. However, there are likely vast differences in the amount of time~     individuals spend actively training (during rehabilitation sessions in the clinic) and what~     they do in their non-training time (during daily life). The activity, or lack of, during the~     non-training period could interfere (positively or negatively), with the specific training in~     the rehabilitation session. However, there is little information available about this.~      Inertial measurement units are increasingly being used in human movement and rehabilitation~     research. The use of such technology is a promising approach to rapidly and discreetly~     collect objective movement information. The investigators plan to introduce a novel,~     long-term, activity sensor into clinical SCI rehabilitation. The investigators use this~     sensor to precisely measure movement of the upper limb over extended periods of time. Upper~     limb activity recordings from these sensors allow us to detail the amount and duration of~     activity during specific periods of upper limb rehabilitation and recovery.~      The investigators aim is to measure upper limb activity. The investigators aim to track~     changes in the activity of the upper limb during recovery and rehabilitation in patients with~     cervical SCI as well as collect reference values of upper limb activity in chronic sufferers.~     The recordings from this activity sensor will provide a more detailed understanding of how~     everyday upper limb activity contributes to functional recovery.~   "
112257|NCT02098109|"~     This study will compare the results of stem cell mobilization using drugs called filgrastim~     (Neupogen) and plerixafor with the results of stem cell mobilization using drugs called XM02~     filgrastim (Granix) and plerixafor.~   "
112258|NCT02098096|"~     The purpose of this study is to develop a negative work exercise regimen as an intervention~     for posttraumatic osteoarthritis (PTOA). Negative work is the force produced by muscles as~     they lengthen, and regularly occurs with common activities such as lowering an object from a~     shelf or walking down stairs. In this study, the investigators are examining the~     effectiveness of negative work exercise over a 12-week period in older, male, Veterans.~   "
112260|NCT02098070|"~     The focus of the study is to determine the prevalence and variance of self-reported knee pain~     characteristics in a community-derived sample of adults aged 40 years and over. It will also~     identify characteristics such as structural changes of osteoarthritis of the knee as well as~     physiological parameters and blood and urine biomarkers.~   "
112262|NCT02098044|"~     The OA and Football Study is an epidemiological study designed to establish the prevalence of~     knee osteoarthritis in retired professional footballers. The study will also identify the key~     risk factors associated with knee osteoarthritis. The study is comprised of three phases:~     Phase I involves the dissemination of a questionnaire (demographic details, players history,~     injury and surgery and other known risk factors of OA), Phase II is a radiographic study that~     involves x-rays in a sample of footballers both with and without knee pain and Phase III is a~     case control study which will compared retired professional footballers with age-matched~     controls recruited from the general population in the East Midlands region.~   "
112263|NCT02098031|"~     Undernutrition and growth restriction due to poor diet and inadequate nutrient intake~     continues to be a global challenge, particularly in the developing countries including~     Uganda. The etiology of inadequate nutrient supply to infants may relate to lack of resources~     or knowledge or a combination of both. Poor nutrient intake and impaired growth may affect~     brain and cognitive development.~      This study aims to evaluate nutrient intake, growth and cognitive function among children~     between 6 and 36 months living in the fertile Kabale and Kisoro region in south-western~     Uganda. The investigators hypothesize that nutrition education to mothers can bring about~     improved dietary intake and nutritional status among children aged 6-36 months.~   "
112264|NCT02098018|"~     There are many ways to reduce stress. This study will compare 2 different programs for~     reducing stress. In addition to looking at how well the programs reduce stress, we will also~     ask questions about how these programs may be working.~   "
112265|NCT02098005|"~     Chronic spinal pain (CSP) includes chronic low back pain, failed back surgery, chronic~     whiplash associated disorders, chronic non-traumatic neck pain, etc. The current~     investigators and others have provided evidence for impaired motor control of spinal muscles~     in patients with CSP. In addition, there is increasing evidence that central mechanisms, i.e.~     hyperexcitability of the central nervous system and brain abnormalities (e.g. decreased brain~     matter density) play a role in CSP. Hence, treatments for CSP should not only address the~     spinal muscles and joints, but also the brain. Therefore, a modern neuroscience approach,~     comprising of pain neuroscience education followed by cognition-targeted motor control~     training, can be applied.~      The scientific objective entails examining the effectiveness of the modern neuroscience~     approach vs. usual care evidence-based physiotherapy for reducing pain and improving~     functioning in Flemish patients with CSP. A secondary objective entails examining the~     effectiveness of the modern neuroscience approach vs. usual care evidence-based physiotherapy~     for altering brain's structure and function (magnetic Resonance Imaging) in Flemish patients~     with CSP. Therefore, a multi-center triple-blind randomized controlled trial will be~     conducted.~      To comply with this scientific objective, 120 CSP patients will be recruited and subjected to~     the baseline assessment. The baseline assessment includes the assessment of pain (including~     symptoms of central sensitization and conditioned pain modulation), the assessment of~     restrictions in functioning, brain imaging, the evaluation of motor control and muscle~     properties, spinal mobility, and psychosocial correlates. Baseline analysis will provide~     descriptive statistics and will lead to calculate correlation between the different outcome~     measures and predictors of pain and dysfunctioning. In a next step, included patients will be~     randomized to the experimental or control group. Those in the experimental group will receive~     neuroscience education combined with cognition-targeted motor control training. Those in the~     control group will be subjected to a control intervention, including back/neck school and~     general exercises. After the neuroscience education has been given, the experimental subjects~     will fill in the neurophysiology of pain test. Several follow-up assessments will take place.~     Part of the assessment (functionality (PDI questionnaire) and psychosocial correlates (Pain~     Catastrophizing Scale (PCS), pain vigilance and awareness questionnaire (PVAQ), Tampa Scale~     for Kinesiophobia (TSK), Illness Perception Questionnaire revised (IPQ-R)) will be~     re-evaluated after the first 3 sessions. The complete 'baseline' assessment will be repeated~     in the month following the treatment complement, rounding up the short-term follow-up~     assessment. Six months after the baseline assessment, pain, functioning and psychological~     correlates are assessed in an intermediate online assessment. One year after baseline~     assessment the complete assessment is repeated for the last time, unless the intermediate~     assessment indicates that treatment effects are no longer present. Both short and long term~     treatment effects can be studied and predictors for therapy success can be unraveled. Also~     correlations between changes in different outcome measures can provide relevant and~     innovative information.~      The proof of principal suggests a strong effect reported by large effect sizes for pain and~     disability compared to usual care.~   "
112266|NCT02097992|"~     The objectives of the proposed study are to determine 1) the effect of a single dose of~     Roflumilast on airway blood flow (Qaw) (study period 1) and 2) the effect of long-term~     Roflumilast treatment on airway blood flow reactivity delta Qaw)(study period 2) in patients~     with stable COPD who use ICS regularly.~   "
112267|NCT02097979|"~     OBJECTIVE Our objective was to determine whether two group educational sessions plus~     one-on-one eye drop instillation training would improve adherence to glaucoma therapy as~     measured by pharmacy claims data in a cohort of newly diagnosed patients. Our hypothesis was~     that adherence would be improved in the intervention group and that patients would better~     understand their disease and how to manage it.~      METHODS Study Design and Population: A randomized controlled clinical trial was conducted in~     newly diagnosed glaucoma patients at Maisonneuve-Rosemont Hospital in Montreal, Canada. Half~     of the participants were randomized to receive the intervention and half were randomized to~     receive a delayed intervention at the conclusion of the study. Inclusion criteria included a~     diagnosis of glaucoma requiring intraocular pressure lowering eye drop therapy and~     prescription drug insurance through the Régie de l'Assurance Maladie du Québec (RAMQ) (the~     Quebec Health Insurance Program) throughout the course of the study. There were three sources~     of data for this study: a questionnaire, the medical record, and RAMQ prescription drug~     claims data. Follow-up was for one year.~      Recruitment and Randomization: From July, 2007 until December, 2011, a researcher approached~     eligible patients to determine their interest in participating in the study. Interested~     participants signed the informed consent form and were randomized. Participants in the~     intervention group were given an appointment to come back to the Hospital for the group~     intervention. Participants in the control group were given an appointment to receive the~     group intervention at the end of the study.~      Intervention: Small groups of about 10 people were gathered for two 60-90 minute educational~     sessions on glaucoma in a classroom at Maisonneuve-Rosemont Hospital. During a break, each~     patient received one-on-one teaching on how to properly instill drops without touching the~     eye or using unnecessary drops.~      Questionnaire and Assessment of Eye Drop Technique: A single questionnaire was given at the~     end of the study to all participants. The intervention group completed the questionnaire~     after the intervention while the control group completed the questionnaire before the~     intervention. Questions were included on demographics, systemic comorbidities, ocular~     medications, eye drop practices and difficulties, and glaucoma knowledge.~      The instructor rated the ability of the participant to put eye drops in the eye taking into~     account the number of drops that were used and whether contact with the lid or conjunctiva~     occurred (good, fair, bad).~      We created a composite score on the perception of the importance of glaucoma eye drop therapy~     using the following four questions: 1) do you think glaucoma is a serious disease, 2) do you~     believe that your treatment will be effective, 3) do you think your drops can lower the~     pressure in your eyes, 4) do you think your drops can help to preserve vision. Answers of no~     or do not know were given 0 points and answers of yes were given 1 point. Scores were summed~     and the composite score ranged from 0 to 4.~      Medical Chart Review: At the end of the follow-up period, information was obtained on: the~     prescribed eye drop therapy for each patient per eye, whether the patient had undergone~     glaucoma filtering surgery, whether the patient had died or was no longer being followed, the~     most recent visual field mean deviation in the better eye using the Humphrey Visual Field~     Analyzer 24-2 SITA Standard Program.~      Pharmaceutical Claims and Calculation of Medication Possession Ratio: The Medication~     Possession Ratio (MPR) was calculated as the sum of days of prescription supply divided by~     the number of days in which a prescription was required. Each person gave consent to contact~     the RAMQ to obtain pharmaceutical claims for all glaucoma medications. Data were collected on~     the date of purchase, and the name, dose, and class of the medicine. Data on the number of~     days of medication available per bottle were taken from the Rylander and Friedman studies~     with the minimum value used. For the numerator of the MPR, we calculated how many days of~     medication were available using RAMQ data. For the denominator of the MPR, we calculated the~     number of days that medication was prescribed in the medical chart. We took into account~     whether drops were needed for one or two eyes. If a participant was on multiple medications,~     we calculated a single mean MPR for all medications. We then dichotomized the MPR so that~     those having medication less than 75% of the days were defined as non-adherent, as we did~     previously in Djafari et al.~      SIGNIFICANCE Adherence can be a problem in glaucoma because patients must often take daily~     eye drops despite not noticing any benefit to their vision and despite frequent side effects.~     Low cost interventions that help to improve adherence are needed.~   "
112268|NCT02097966|"~     The primary objective of this program is to provide Daclatasvir in combination with~     Sofosbuvir with or without Ribavirin to subjects with chronic Hepatitis C who are at a high~     risk of liver decompensation or death within 12 months if left untreated and who have no~     available therapeutic options.~   "
112269|NCT02097953|"~     The purpose of this study is to understand how an antibiotic, rifampin, may change the blood~     levels of another antibiotic, daptomycin, in the body. In addition, the effect of~     polymorphisms in P-glycoprotein (a protein involved in the removal of daptomycin from the~     body) on the blood levels of daptomycin will be evaluated. The hypotheses are that rifampin~     will decrease the blood levels of daptomycin and that the effect will be greater for certain~     P-glycoprotein polymorphisms.~   "
112270|NCT02097940|"~     This study presents the hypothesis that the sensory processing engine improves balance and~     agility for football athletes.~   "
112271|NCT02097927|"~     The study will be a 3-way crossover design: it will assess the impact of consuming a beverage~     enhanced with satiety-relevant properties on subjective ratings of appetite and on energy~     intake compared with a low energy version with the same sensory characteristics, and a~     non-sensory enhanced high energy control.~      In addition, saliva samples will be collected at regular intervals for the identification of~     novel biomarkers of energy intake.~   "
112272|NCT02097914|"~     The burden of tobacco use falls disproportionately on low-income populations, through high~     rates of primary smoking and exposure to secondhand smoke. The remarkable progress in~     creating smoke-free environments in the U.S over the past two decades has left smoker's homes~     as one of the primary sources of exposure to secondhand smoke for both children and~     nonsmoking adults. Intervention research that identifies effective and practical strategies~     for reaching the minority of households that still allow smoking in the home has considerable~     potential to reduce smoke exposure, but suitable channels to reach low-income families are~     limited.~      The proposed research will systematically test an intervention designed to create smoke-free~     homes in low income households among 2-1-1 callers. During this randomized control trial,~     researchers will disseminate and evaluate a brief smoke-free homes intervention through the~     established infrastructure of a Texas 2-1-1 call center. 2-1-1 is a nationally designated~     3-digit telephone exchange, similar to 9-1-1 for emergencies or 4-1-1 for directory~     assistance, that links callers to community-based health and social services. The main~     hypothesis to be tested is that a higher proportion of households in the intervention group~     will establish and maintain a smoke-free home than in the measures-only control group.~   "
112273|NCT02097901|"~     The hypothesis is that microfractures in the footprint of the humerus will aid to improve the~     tendon healing to the bone. The aim of the study is to investigate whether the use of~     microfractures at the footprint of the rotator cuff will improve the tendon healing when~     reinserted. Patients undergoing surgery for a rotator cuff injury will be randomised to~     repair with or without microfracture.~   "
112274|NCT02097888|"~     This will be a prospective observational study. The investigators will compare Erythropoietin~     (Epo) levels, erythropoiesis, and regulators of erythropoiesis, bone imaging and bone~     metabolism in healthy volunteers living at different altitudes.~   "
112275|NCT02097875|"~     Many types of cancer are primarily treated with surgery and patient survival is directly~     related to the extent to which the tumor is able to be removed. It is often difficult for~     surgeons to distinguish tumor tissue from normal tissue or to detect tumor cells that have~     spread from the original tumor site, resulting in incomplete removal of the tumor and reduced~     patient survival. In addition, in some sites, such as the brain, it is critical to avoid~     damage to normal tissue around the tumor to prevent adverse effects of surgery on function.~     We hypothesize that BLZ-100 will improve surgical outcomes by allowing surgeons to visualize~     the edges of the tumor and small groups of cancer cells that have spread to other sites in~     real-time, as they operate.~   "
112276|NCT02097862|"~     The intent of this clinical study is to answer the questions: 1) Is the proposed treatment~     safe and 2) Is treatment effective in improving the disease pathology of patients with~     diagnosed degenerative disc disease.~   "
112742|NCT02091739|"~     The objective of this study is to investigate the efficacy and safety of two different dose~     levels of NT 201 (75 U or 100 U per cycle), compared with placebo, in reducing the salivary~     flow rate, and the severity and frequency of chronic troublesome sialorrhea that occurs as a~     result of various neurological conditions in adult subjects.~   "
112277|NCT02097849|"~     Primary objective is to evaluate the immune response to vaccination with tetanus diphtheria~     toxoids vaccine (Td) in participants with relapsing forms of Multiple Sclerosis (MS) who have~     been treated with Tecfidera (BG00012) versus those treated with non pegylated interferon~     (IFN).~      Secondary objective is to evaluate the immune response to vaccination with 23-valent~     pneumococcal polysaccharide vaccine (PPSV23) [a mostly T cell-independent humoral response]~     and meningococcal polysaccharide diphtheria conjugate vaccine, quadrivalent (MCV4) [T~     cell-dependent neoantigen response].~   "
112278|NCT02097836|"~     If a child with cerebral palsy does not develop independent sitting balance by 4 years of~     age, their prognosis for walking is very poor. Surprisingly little is known about how to~     facilitate head control or upright sitting balance and functional mobility in the child who~     is not developing these skills. This is one of the first studies that will examine~     intermediate stages in the development of the postural control system in children with~     neurologic deficits. Clinical researchers at The Movement Centre in Oswestry, England have~     developed a method called Targeted Training in which trunk control is trained in children~     segment by segment using a specific training device. This study aims to examine kinematic and~     electromyographic changes in a case series of children who undergo a 6-month Targeted~     Training intervention.~   "
112279|NCT02097823|"~     The purpose of this study is to determine the feasibility of a larger trial comparing~     olanzapine and aprepitant and to obtain preliminary data on the effectiveness of these two~     medications to treat nausea and vomiting in children receiving chemotherapy. Children~     receiving 2 cycles of chemotherapy with a high risk of causing nausea and vomiting will~     receive olanzapine in one cycle and aprepitant in another cycle. Children will be randomized~     to see which medicine they receive first. The investigators will record the number of extra~     medications used for nausea, the number of times a child vomits, and the amount of nausea the~     child feels each day.~   "
112280|NCT02097810|"~     Entrectinib (RXDX-101) is an orally available inhibitor of the tyrosine kinases TrkA (coded~     by the gene NTRK1), TrkB (coded by the gene NTRK2), TrkC (coded by the gene NTRK3), ROS1~     (coded by the gene ROS1), and ALK (coded by the gene ALK). Molecular alterations to one or~     more of these targets are present in several different tumor types, including non-small cell~     lung cancer (NSCLC), colorectal cancer (CRC), prostate cancer, papillary thyroid cancer,~     pancreatic cancer, and neuroblastoma. Patients with locally advanced or metastatic cancer~     with a detectable molecular alteration in targets of interest may be eligible for enrollment.~      Phase 1 will assess safety and tolerability of entrectinib via standard dose escalation~     scheme and determine the recommended Phase 2 dose. Safety and efficacy will be assessed in~     the dose expansion portion of the study.~   "
112281|NCT02097797|"~     Crohn's disease is a chronic and relapsing inflammatory bowel disease. Many data show that~     the intestinal flora is involved in the disease and it has been show that patients with~     Crohn's disease exhibit an abnormal fecal flora that might play a role in inflammation. The~     purpose of this study is to determine the effect of the fecal flora transplantation on~     Crohn's disease.~   "
112282|NCT02097784|"~     This prospective study focuses on the interest of the echocardiography for cirrhotic~     patients, who present acute kidney injury corresponding to the criteria of hepatorenal~     syndrome. This echocardiography will be done before the volemic expansion and the final~     diagnostic of hepatorenal syndrome or prerenal azotemia. The primary endpoint is to describe~     the hemodynamic characteristics of this population at the time of acute kidney injury and~     their association with diagnostic of hepatorenal syndrome or prerenal azotemia. Patients with~     elevated filling pressure, predicting poor outcome of volemic expansion will be excluded of~     the study after the echocardiography and will not undergo volemic expansion but appropriate~     management.~   "
112283|NCT02097771|"~     Comparison of the incidence of gastric insufflation between two kinds of laryngeal masks~     airways: LMA SupremeTM vs Ambu AuraOnceTM~   "
112284|NCT02097758|"~     Background: Three-dimensional echocardiographic image for atrial septal defect (ASD) is~     useful for evaluation of defect size and shape. The investigators suggested optimal device~     size using three-dimensional transesophageal echocardiographic image and our formula in~     previous study.~      Purpose: In this study, the investigators seek to predict the correct device size and confirm~     the accuracy of the formula that we made before device closure in ASD patients.~   "
112285|NCT02097745|"~     This study will assess the long-term safety and efficacy of repeating treatment with~     MabThera, in combination with methotrexate and steroids, in patients who were previously~     randomized into MabThera study WA17042. The anticipated time on study treatment is until~     Mabthera is available on the local market and the target sample size is 100-500 individuals.~   "
112286|NCT02097732|"~     This is a study to test the efficacy of using standard immune therapy for melanoma prior to~     stereotactic radiosurgery (ipilimumab induction), as compared to stereotactic radiosurgery~     followed by immune therapy. The study's hypothesis is that ipilimumab induction is as good as~     or better than controlling brain metastases as compared to stereotactic radiosurgery followed~     by immune therapy.~   "
112287|NCT02097719|"~     This efficacy and safety study will evaluate LUMIGAN® .01 (bimatoprost 0.01%) alone compared~     to TRAVATAN Z® (travoprost 0.004%) and TIMOLOL GFS, 0.5% (timolol 0.5% ophthalmic gel forming~     solution) in patients who require IOP lowering therapy.~   "
112295|NCT02097615|"~     At present research has generated controversy regarding the utility of antiseptics in wound~     management for diabetic foot ulcers syndrome. However, these studies have been done in~     tissues and animal models. This study involves the best presently antiseptic for residual~     effect and low toxicity in an approach to eliminate microorganisms promoters formation of~     biofilm, contributing to the treatment for accelerated closure the diabetic foot ulcers~     syndrome .~      So it is necessary to determine if irrigation ulcer diabetic foot syndrome with chlorhexidine~     0.125 % aqueous solution determines the decrease of the surface to a greater extent than the~     standard treatment using irrigation with sterile deionized water .~   "
112296|NCT02097602|"~     This is an observational study designed to monitor the course of the fraction of reticulated~     platelets and the correlation thereof to major adverse cardiac and cerebrovascular events~     after noncardiac surgery.~   "
112297|NCT02097589|"~     The purpose of this research study is to: Improve the effectiveness of vaccinations by~     identifying the effect of cholesterol medication, statins, on immune responses.~   "
112288|NCT02097706|"~     Borderline Personality Disorder (BPD) is one of the most prevalent psychiatric disorders with~     high morbidity and mortality. It affects the lives of millions worldwide and is often highly~     incapacitating, leading to significant psychosocial dysfunction. Moreover, nearly all~     patients have experienced suicidal ideation and about 10% actually commit suicide, a rate~     almost 50 times higher than in the general population. Mostly young women are at greater risk~     for the disorder and are three times more likely to be diagnosed with BPD than men.~      BPD aetiology is complex and could be explained by both biological and environmental factors.~     Among the environmental factors, sexual or physical abuse, parental divorce, loss or~     illnesses are identified as the most common ones. These factors can induce dysfunctional~     behaviours, which might cause emotional dysregulation, high impulsivity and frequent self-~     injurious behaviour.~      However, there are no pharmacologic interventions that are known to be specifically effective~     to treat BPD. Therapeutic options for this devastating disorder is still far from adequate~     for treating acute illness episodes, relapses, and recurrences and in restoring premorbid~     functioning. In addition, some patients are unable to tolerate existing therapies for BPD,~     which leads to either frequent changes in medications or to non-adherence. Therefore there is~     an urgent need for the development of more rapidly effective treatments for BPD.~      A growing body of evidence suggests that glutamatergic neurotransmission, in particular~     N-methyl-D-aspartate (NMDA) subtype may play a role in the pathophysiology of multiple~     psychiatric disorders. This has led to various clinical trials with glutamate modulating~     drugs. The trial drug is an uncompetitive NMDA receptor antagonist approved for Alzheimer's~     disease is increasingly being studied in a variety of non-dementia psychiatric disorders.~     Results from these studies have proved that the trial drug was safe and well tolerated and~     has the potential for use in the treatment of psychiatric disorders.~      To date, there are no published data on the use of trial drug in the treatment for BPD.~     Therefore, the investigators intend to study the efficacy of this novel drug as an addition~     to ongoing therapy with atypical antipsychotics in patients with Borderline Personality~     Disorder. This study will recruit 30 BPD patients. The patients will be randomly allocated to~     receive either the study medication (20mg/ day) or placebo via oral administration for eight~     weeks. To observe the efficacy of the trial treatment, all participants will be assessed at~     various time intervals for different borderline and cognitive symptoms.~   "
112289|NCT02097693|"~     There are limited therapeutical options for patients with secondary dystonia due to cerebral~     palsy. Pharmacotherapy is often without effect, or side effects are severe. Meanwhile deep~     brain stimulation (DBS) has proven to be a safe and effective therapy for patients with~     parkinson´s disease or primary / idiopathic dystonia. Experiences with DBS in patients with~     dyskinetic cerebral palsy are limited with heterogeneous data.~      With STIM-CP we investigate the effect of DBS on quality of life in young patients with a~     dyskinetic movement disorder (dyskinetic cerebral palsy) due to perinatal hypoxic brain~     injury. Additionally, the effect of DBS on motor development, speech, memory, attention,~     cognition and pain perception will be assessed. In total, 20 patients aged 7-18 years~     diagnosed with dyskinetic cerebral palsy, who will receive DBS, should be included. 11 German~     DBS-centres will participate in the trial.~      We assume that DBS reduces the severity of dystonia and improves the quality of life in these~     patients.~   "
112290|NCT02097680|"~     It seems plausible that increased aromatase activity in obese men, as a result of a larger~     fat mass, is responsible for decreased levels of testosterone. Therefore aromatase inhibition~     increases testosterone levels, which may affect hepatic and cardiac function.~      In this intervention study two groups of hypogonadal obese men are compared. Group A is~     treated with Letrozole 2.5 mg (aromatase inhibitor) once every two days during four months; a~     group with normal testosterone and low oestrogen concentrations. Group B is treated with~     placebo once every two days during four months; this group will retain low testosterone - and~     high oestrogenic concentrations.~      The primary objective of the study is to evaluate effects of changed sex steroids in obese~     men on hepatic and cardiac function.~   "
112291|NCT02097667|"~     Fetal Growth Restriction (FGR) is a major obstetric problem, affecting 1.46 million fetuses~     worldwide each year and contributing to 50% of stillbirths. Severe early onset FGR affects 1~     in 500 pregnancies, leading to stillbirth or the need for delivery before 28 weeks gestation.~     The combination of FGR and prematurity is associated with a significant risk of neonatal~     mortality and short and long-term complications. Even modest increases in birthweight (e.g~     from 500 to 600g) and gestation at delivery (e.g from 26 to 27 weeks) are associated with~     significantly better outcomes but there are currently no treatments.~      The EVERREST Clinical Trial, funded by the European Commission, aims to develop a treatment~     which will increase fetal growth in severe early onset FGR. It will use gene therapy injected~     into the uterine arteries of the mother to increase the levels of vascular endothelial growth~     factor (VEGF) and so increase uterine artery blood flow and fetal growth.~      The EVERREST prospective study aims to form a clinical database and biobank of pregnancies~     affected by severe early onset FGR to improve understanding of the condition and serve as a~     comparison to assess the safety and efficacy of this intervention.~      The prospective study will take place across four European centers who will later take part~     in the EVERREST Clinical Trial. Women with singleton fetuses with early onset FGR will be~     approached to take part in the study. Participating women will provide blood samples, details~     of their clinical condition, samples of umbilical cord blood, placenta and myometrial and~     placental bed biopsies at the time of Caesarean section (if needed). Data on short and~     long-term outcomes of the babies will be collected. All data will be entered onto a central~     database for eventual use as a comparator for treated women on the EVERREST Clinical Trial,~     for which separate ethical approval will be sought.~   "
112292|NCT02097654|"~     Primary Objective: To quantify the benefits of the SENATOR decision support software on the~     reduction of ADR rates in older hospitalized patients. Secondary Objectives: To evaluate the~     effect of SENATOR with regard to use of appropriate non‐pharmacological therapies in subjects~     with one core geriatric syndrome.~      Tertiary Objectives: to examine the association of SENATOR use with subject survival,~     morbidity and health related quality of life.~      Health Economic Objective: To examine the potential health economic consequences of using~     SENATOR.~      There are two study periods:~      Period I: Prospective multinational, multicentre observational study to estimate the baseline~     adjudicated medical and surgical ADR rates by clinical sub speciality in 6 international~     sites.~      Period II: Prospective multinational, multicentre, cluster randomized, two parallel arm, open~     label, controlled trial, with blinded outcome ascertainment, of the efficacy of SENATOR~     software in reducing ADRs in older hospitalized subjects.~   "
112293|NCT02097641|"~     This is a Phase 2, randomized, double-blind, placebo-controlled, multi-center study to assess~     the safety and efficacy of a single dose of Allogeneic Bone Marrow-derived Human Mesenchymal~     Stem Cells infusion in patients with Acute Respiratory Distress Syndrome (ARDS). This study~     is the extension of the Phase 1 pilot study (NCT01775774). Patients will be randomized to~     receive Human Mesenchymal Stem Cells infusion or placebo in a 2:1 allocation. Patients will~     be followed daily for adverse events through day 28, death or hospital discharge, whichever~     occurs first. Vital status will be collected at 6 and 12 months after study enrollment.~   "
112294|NCT02097628|"~     The purpose of this study is to compare volume- and pressure- controlled ventilation with~     laryngeal mask airway Guardian in obese patients undergoing laparoscopic gynecologic surgery~     in terms of ventilatory efficacy, airway leak pressure (airway protection), ease-of-use and~     complications.~   "
112342|NCT02097004|"~     A randomized, Open label, Single center, Prospective study to compare efficacy and safety of~     Therapeutic Vaccination with Intensified schedule plus Pegylated Interferon dual Therapy on~     Seroclearance of Hepatitis B virus Surface Antigen in Patients with Complete Virological~     Response Induced by Entecavir~   "
112298|NCT02097576|"~     The purpose of this study is to evaluate whether high-volume nasal rinses with a manuka~     honey/saline mixture will improve symptom scores, nasal endoscopic findings and CT scan~     findings compared to nasal saline rinse without manuka honey in patients with chronic~     rhinosinusitis.~      Manuka honey is a honey made from bees that drink the nectar from tea (manuka) trees in New~     Zealand. It has been shown to have antibacterial activity against common bacteria that cause~     chronic sinusitis.~   "
112299|NCT02097563|"~     The present study aims to :~        1. compare different approaches (high intensity vs. low intensity) to training community~          providers (those who routinely treat young patients with bipolar disorder, psychosis, or~          sub-threshold high-risk conditions) on the implementation of family-focused treatment~          (FFT);~        2. assess the cost of FFT training and implementation support; and~        3. determine whether these different forms of clinician training are associated with~          different outcomes over 1 year among patients with early-onset mood and psychotic~          disorders.~   "
112300|NCT02097550|"~     This project seeks to improve the health of patients with chronic kidney disease (CKD) by~     developing and testing an electronic health intervention (that will combine secure e--mail,~     smartphone text message, and online video materials) to promote patient use of effective~     medications. The information we collect on the electronic health intervention will guide~     future research, including a larger trial and other studies among related patient groups~     (e.g., racial minorities) and diseases (e.g., type 2 diabetes mellitus). The project has the~     potential to improve health outcomes for the millions of patients with CKD who are not yet~     receiving effective medications.~   "
112301|NCT02097537|"~     The Purpose of this study is to evaluate the safety and efficacy of SK-1211 inhalation~     challenge in children with bronchial asthma.~   "
112302|NCT02097524|"~     The main purposes of this study are to describe the pharmacodynamic effects, safety and~     pharmacokinetics of a single dose of sarilumab.~   "
112303|NCT02097511|"~     This is a randomized, open-label, single & multiple-dose, three-sequence, three-period~     crossover study to investigate the effect of sarpogrelate hydrochloride on the disposition of~     metoprolol tartrate in healthy male volunteers~   "
112304|NCT02097498|"~     The overall objective of the present proposal is to assess whether medical simulation can~     enhance the safety and proficiency profile of paramedics performing prehospital endotracheal~     intubation, and whether feedback from an airway management expert observing the simulation~     enhances skill retention after 12 and 24 months. Since no validated proficiency assessment~     tool currently exists to measure the skill of paramedics in airway management, one will be~     developed and tested. Using this tool, 250 paramedics in central Ohio, will undergo~     simulation training similar to that required for certification. A baseline assessment of~     proficiency will be obtained. One group will be randomized to receive simulation training~     similar to that required for certification, while the other group will receive feedback from~     an airway management expert linked to the simulation test site via a 2-way audio-video feed.~     Both groups of paramedics will be reassessed at 12, and 24 months to determine whether skill~     level was maintained or whether skills deteriorated, and whether expert intervention had any~     impact on skill retention.~   "
112305|NCT02097485|"~     The purpose of the study is to evaluate ovicidal efficacy of a single application of~     abametapir lotion 0.74% w/w intended for the treatment of head lice.~   "
112306|NCT02097472|"~     The purpose of this study is to assess the safety and tolerability of PATH-wSP, administered~     intramuscularly to healthy Kenyan adults and toddlers who have been primed with a~     pneumococcal conjugate vaccine (PCV).~      Additionally, the study will explore whether a measurable immune response is elicited when~     PATH-wSP is administered to healthy Kenyan adults and toddlers who have been primed with PCV.~   "
112307|NCT02097459|"~     It suggests in the Guideline that the postmenopausal women with breast cancer who have taken~     selective estrogen receptor modulators (SERMs) therapy for 2-3 years could benefit from~     changing endocrine therapy to aromatase inhibitors (AIs). This is a prospective, randomized~     and non-inferior trial to evaluate the prognosis of changing endocrine therapy from SERMs to~     AIs in perimenopausal and recently postmenopausal women with early-stage hormone~     receptor-positive breast cancer.~   "
112308|NCT02097446|"~     -  Indication: Benign tumors of ovary(mature teratoma, mucinous cystadenoma, serous~          cystadenoma)~        -  Intervention: Device ( Test group : Guardix-FL, Control group : Interceed)~        -  Primary Outcome Measure : Anti-adhesion Rate~        -  Assessment : Operative Day(Visit 2), Post-Operative Day+7days(Vist 3), Post-Operative~          Day+4weeks(Visit4), Post-Operative Day+5weeks(Visit 5)~   "
112309|NCT02097433|"~     As part of the global clinical development program for Dacomitinib, studies are planned in~     cancer patients in China. An assessment of Dacomitinib pharmacokinetics in Chinese subjects,~     as required by the Chinese Health Authorities, is therefore warranted.~      The single 45 mg oral dose pharmacokinetics of Dacomitinib will be characterized.~   "
112310|NCT02097420|"~     The purpose of the study is to provide evidence of safety and effectiveness of the study~     valve. The rationale is to offer a replacement mitral valve for patients with anatomy that is~     too small for the currently commercially available valves ranging in size from 16mm to 37mm.~   "
112311|NCT02097407|"~     Dexmedetomidine is a useful anaesthetic adjuvant for general anaesthesia. In this prospective~     randomised study, we determined whether preoperative dexmedetomidine administration could~     reduce the half maximal effective concentration (EC50) of propofol for successful i-gelTM~     insertion without muscle relaxants.~   "
112312|NCT02097394|"~     The study hypothesis is whether digestion enzyme(Combizym) and intestinal flora~     drugs(Bifidobacteria) can decease recurrence rate of colon polyps~   "
112343|NCT02096991|"~     -  Bisphenol A(BPA) is an endocrine disrupting chemical, which mimics the action of~          estrogen.~        -  Previous studies reported that BPA exposure is associated with increased risk of~          cardiovascular diseases.~        -  Exposure to BPA occur mainly through oral route, and epoxy coating of canned food is one~          of the well established source.~        -  The investigators hypothesis is that increased BPA exposure from canned beverage would~          disrupt normal physiology in a short term.~        -  In the present trial the investigators are to investigate whether increased BPA exposure~          by consuming canned beverage actually affect cardiovascular indices and epigenetic~          feature.~        -  For this aim, the investigators will conduct a cross-over trial.~   "
112313|NCT02097381|"~     HIV infection is associated with a state of chronic, generalized immune activation that has~     been shown in many studies to be a key predictor of progression to AIDS. The molecular,~     cellular, and pathophysiological mechanisms underlying the HIV-associated immune activation~     are complex and still poorly studied. There is, however, growing consensus that both viral~     and host factors contribute to this phenotype, with emphasis on the role played by the~     mucosal immune dysfunction (and consequent microbial translocation). Moreover if it is known~     that in HIV-infected individuals, a severe depletion of intestinal cluster of differentiation~     4 (CD4+) T-cells, is associated with loss of epithelium integrity, microbial translocation~     and systemic immune activation, the kinetics of intestinal CD4+ T-cell reconstitution under~     combined antiretroviral therapy (cART) remains poorly understood.~      This study sought to evaluate the reconstitution of intestinal CD4+ T-cells, including Th1~     and Th17, in blood and colon samples collected from HIV-infected individuals before and after~     a short term cART.~   "
112314|NCT02097368|"~     The main objective is prospectively study the upper airways function in an adult population~     of neuromuscular patients. The main measurement will be the evolution of tongue strength~     recorded each year during annual clinical evaluation on a 5 years period.~   "
112315|NCT02097355|"~     TriVox Health is an online system designed to make it easy for healthcare providers to~     monitor patients' disease symptoms and functioning over time and in between in-person visits~     (http://www.youtube.com/watch?v=VR1vcbx0Ef4). Using combined quality improvement and~     randomized clinical trial methods, we will evaluate the impact of TriVox on the health~     outcomes, patient/family experience of care, and healthcare utilization for children and~     adolescents with Attention Deficit Hyperactivity Disorder (ADHD), asthma, autism, depression,~     and epilepsy.~   "
112316|NCT02097342|"~     This study is planned to evaluate if linagliptin can improve insulin sensitivity in patients~     with type 2 diabetes mellitus. In addition, the effect of linagliptin on pancreatic function~     will be studied.~   "
112317|NCT02097329|"~     To investigate the effect of acid reducing agents (an antacid and an H2-receptor antagonist~     and a proton pump inhibitor) on palbociclib bioavailability in the presence of food.~   "
112318|NCT02097316|"~     The study will be conducted, in cross-over with a time interval of at least 2 days between 2~     treatment periods. Patients will be randomized into 2 groups According to the order of the~     randomization, patients will bear the JewelPump for 5 days, followed by a period of 5 days of~     treatment with their usual pumps.~   "
112319|NCT02097303|"~     This is an open label study designed to examine the effects on concurrent administration of~     Radium Ra 223 dichloride and Abiraterone Acetate plus Prednisone in subjects with symptomatic~     castrate resistant prostate cancer and with bone metastases, in both the pre- and post-~     chemotherapy setting. Both medications are approved by the US Food and Drug Administration~     for this indication.~   "
112320|NCT02097290|"~     This study will evaluate the PaceSafe Right Ventricular Autothreshold (RVAT) and Left~     Ventricular Autothreshold (LVAT) features for AUTOGEN Cardiac Resynchronization Therapy~     Defibrillator (CRT-D) devices.~   "
112321|NCT02097277|"~     The purpose of this study is to assess the potential of BMS-986036 for treatment obese adults~     with type-2 diabetes.~   "
112322|NCT02097264|"~     This trial is conducted in Europe. The aim of the trial is to investigate the mechanism of~     action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid~     arthritis (RA) and an inadequate response to Methotrexate.~   "
112323|NCT02097251|"~     Emergency access granted to treat a single patient with advanced Mucopolysaccharidosis Type 7~     with UX003 Recombinant Human Beta-glucuronidase (rhGUS) Enzyme Replacement Therapy via IV~     administration every other week (QOW) for up to 144 weeks.~   "
112324|NCT02097238|"~     This phase II trial studies how well eribulin mesylate works in treating patients with~     osteosarcoma that has come back after treatment (recurrent) or has not responded to treatment~     (refractory). Microtubule inhibitors, such as eribulin mesylate, may stop or slow the growth~     of tumor cells by disrupting the cell cycle.~   "
112325|NCT02097225|"~     This phase I trial studies the side effects and best dose of onalespib when given together~     with dabrafenib and trametinib in treating patients with BRAF-mutant melanoma or solid tumors~     that have spread to another place in the body (metastatic) or cannot be removed by surgery.~     Onalespib, dabrafenib, and trametinib may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth.~   "
112326|NCT02097212|"~     The investigators hypothesize that there is a strong correlation between OSA and TBM/HDAC.~     Our hypothesis is based on the similarities in mechanism (airway collapse), symptoms (daytime~     and nocturnal dyspnea) predisposing conditions (obesity and neuromuscular abnormalities of~     the chest wall and the diaphragm), and effect of interventions (CPAP and BIPAP) in these~     diseases.~   "
112327|NCT02097199|"~     This study investigates the influence of an increased physical activity and sports workload~     in formerly nonsporting healthy individuals on current promising biomarkers of~     atherosclerosis research.~   "
112328|NCT02097186|"~     Major vascular surgery involves operations to repair swollen blood vessels, clear debris from~     blocked arteries or bypass blocked blood vessels. Patients with these problems are a~     high-risk surgical group as they have generalized blood vessel disease. These puts them at~     risk of major complications around the time of surgery such as heart attacks , strokes and~     death. The mortality following repair of a swollen main artery in the abdomen is about 1 in~     20. This contrasts poorly with the 1 per 100 risk of death following a heart bypass. Simple~     and cost-effective methods are needed to reduce the risks of major vascular surgery. Remote~     ischaemic preconditioning (RIPC) may be such a technique. To induce RIPC, the blood supply to~     muscle in the patient's arm is interrupted for about 5 minutes. It is then restored for a~     further five minutes. This cycle is repeated three more times. The blood supply is~     interrupted simply by inflating a blood pressure cuff to maximum pressure. This repeated~     brief interruption of the muscular blood supply sends signals to critical organs such as the~     brain and heart, which are rendered temporarily resistant to damage from reduced blood~     supply. Several small randomized clinical trials in patients undergoing different types of~     major vascular surgery have demonstrated a potential benefit. This large, multi-centre trial~     aims to determine whether RIPC can reduce complications in routine practice.~   "
112329|NCT02097173|"~     This study is conducted to assess the relative bioavailability of MTX administered~     subcutaneously via a prefilled pen (50mg/mL) compared with MTX administered via IM injection~     (25mg/mL).~   "
112330|NCT02097160|"~     The study is a parallel interventional randomized dose-response trial designed to improve~     vitamin D intakes through food in a group of healthy 2 - 7.9 year old children. Subjects will~     be recruited from the general population in the greater Montreal area. The study will be~     conducted at the Mary Emily Clinical Nutrition Research Unit of McGill University. Children~     will be required to attend two study visits. Some information will be collected through~     monthly telephone survey to the parents. The investigators will add vitamin D to cheese and~     yogurt for daily consumption at home over a three month period. All products will be provided~     to the parents in the form of coded containers that do not contain any labels aside from the~     group and expiration date. Ingredient lists will be provided upon consenting to the study. To~     better understand vitamin D status; dietary intake, hematology, serum biochemistry including~     25(OH)D, growth, and body composition will be measured at the beginning and end of the three~     month study period. In addition, bone mass at baseline will be assessed. Sun exposure will be~     documented and a skin pigmentation test will be used to more objectively assess chronic sun~     exposure. The investigators will also investigate the association between vitamin D intake~     and status with immune function.~   "
112331|NCT02097147|"~     To compare the effects of vilazodone, paroxetine and placebo on sexual function in sexually~     active healthy adults.~   "
112332|NCT02097134|"~     This pilot clinical trial studies whether unilateral group D retinoblastoma, or~     retinoblastoma affecting one eye that has spread to the inner jelly like part of the eye, can~     be treated with a new technique for delivering chemotherapy directly into the blood vessel~     that supplies the affected eye. This new technique is called intra-arterial injection. This~     may give children with unilateral retinoblastoma a lower chance of needing surgery to remove~     the eye and reduce the amount of treatment side effects.~   "
112333|NCT02097121|"~     This study will evaluate the safety and efficacy of onabotulinumtoxinA (BOTOX®) for the~     treatment of urinary incontinence due to overactive bladder in pediatric patients between the~     ages of 12 to 17 years who have not been adequately managed with anticholinergics.~   "
112334|NCT02097108|"~     This is a 24-week, one arm, open-label, interventional, non-comparative multicenter study to~     evaluate lipid changes in HIV infected women with hyperlipidemia on boosted PI based regimen~     after switching their boosted PI to raltegravir at standard dosage with 400mg twice daily.~      This study aims to study the effect on metabolic profiles by switching hyperlipidemic HIV~     infected women from a PI based regimen to raltegravir.~   "
112335|NCT02097095|"~     This is an independent optional sub-study parallel to TB-018 (NCT01755598) in which~     biological samples will be collected for future investigations on biological correlates,~     markers or prognostic factors for TB disease. Subjects who consent to enroll in TB-018, A~     phase IIb, double-blind, randomised, placebo-controlled study to evaluate the efficacy,~     safety and immunogenicity of GSK Biologicals' candidate tuberculosis (TB) vaccine GSK 692342~     (M72/AS01E) against TB disease, in healthy adults aged 18-50 years, living in a TB endemic~     region, (see NCT 01755598) will be asked to participate in this sub-study. Subjects enrolled~     in TB-018 who also consent to C-041-972 will be followed according to the TB-018 protocol but~     will have additional blood samples collected for the sub-study.~   "
112336|NCT02097082|"~     An evaluation of the safety and performance of the STANZA Drug-eluting Resorbable Scaffold~     (DRS) system for the treatment of patients with obstructive superficial femoral artery~     disease.~   "
112337|NCT02097069|"~     The investigators aim to compare the effect of different inositol stereoisomers~     supplementation in lowering insulin resistance levels after 8 weeks of treatment in pregnant~     women with GDM and in preventing adverse obstetric outcomes.~      The study population includes 80 women with GDM, randomly allocated to subgroup A (folic acid~     400 mcg/day), subgroup B (myo-inositol 2000 mg twice a day), subgroup C (D-chiro-inositol 250~     mg twice a day), and subgroup D (Myo-inositol plus D-chiro-inositol 550mg/13,8 mg twice a~     day).~      Folic acid or inositol stereoisomers will be administered starting at the enrolling time~     (24-28 week gestation, after GDM diagnosis) till the delivery.~      The homeostasis model assessment of insulin resistance (HOMA-IR) and the sensitivity index~     (QUICKI) will be checked at the moment of the diagnostic oral glucose tolerance test (24-28~     weeks) and after 8 weeks of treatment. Obstetric outcomes, the rate of women needed insulin~     therapy and insulin dosage will be registered.~   "
112338|NCT02097056|"~     This is a multi-center, open-label, single-arm, prospective, phase IV trial, evaluating~     safety and efficacy of donepezil hydrochloride in patients with moderate to severe~     Alzheimer's disease.~   "
112339|NCT02097043|"~     This study is a phase I clinical trial for evaluating the pharmacokinetics and~     safety/tolerability of DA-7218 in healthy male volunteers.~   "
112340|NCT02097030|"~     The objective of the study is to compare the overall subjective preference of filcon II 3~     daily disposable silicone hyrogel contact lenses compared to etafilcon A and nelfilcon A~     daily disposable conventional hydrogel contact lenses.~   "
112341|NCT02097017|"~     To examine whether application of lidocaine spray in cervical preparation for second~     trimester dilatation and evacuation alleviates pain and is superior to current protocol of~     preparation without analgesia and superior to placebo.~      Methods A prospective randomized placebo controlled trial consisting of three groups~        1. Lidocaine spray group (group 1)~        2. Placebo group (saline spray) (group 2)~        3. No intervention group (as currently in our protocol) (group 3)~             -  Women undergoing dilatation and Evacuation in the second trimester and are about to~               go cervical dilation with osmotic dilators(laminaria) will be invited to~               participate in the randomized placebo control trial comparing lidocaine spray,~               placebo (saline) or no application (as current protocol).~             -  Informed consent will be obtained from each participant~             -  After enrollment patient will be randomized into one of the three study arms by a~               computer program~             -  The patient will be placed in the lithotomy position and the cervix will be exposed~               using a sterile bivalve speculum.~             -  Pain will be assessed in 3 places using a visual analog pain scale 10(no pain) to~               100 (worst possible pain).~                0 after removal 15~             -  Group1 :after speculum insertion 4 puffs (40mg) of spray will be applied to the~               cervix and after a 2 minute wait laminaria will be inserted.~             -  Clinical data will be collected including age, parity, general health, Obstetric~               and gynecologic history.~             -  Primary outcome : difference in pain score immediately after speculum removal and~               10 minutes after speculum removal~             -  The protocol will not be repeated if a participant is to return for further~               laminaria insertion.~      Sample size A sample size was calculated assuming a target difference of 10 (smallest effect~     of clinical importance) between the baseline and post laminaria pain score at 15 minutes.~     Standard deviation was assumed to be 18 based on similar power. Assuming 80% power and a P~     value of 0.05 sample size of each group was calculated to be 51(5) and hence sample size of~     55 was determined .~      Participants~        -  Females aged 16 years and older about to undergo DE Inclusion criteria~        -  Informed consent~        -  Women with a fetus Crown rump length (CRL) greater than 10 weeks via ultrasound.~      Exclusion criteria~        -  CRL < 10 weeks~        -  Clinical Uterine size >22 weeks~        -  Fetus Bi Parietal Diameter > 50 mm~        -  Known amide allergy Withdrawal criteria~        -  Immediate adverse reaction to amides~   "
112743|NCT02091726|"~     This is a field trial of the Unicirc instrument to excise the foreskin, plus use of~     cyanoacrylate tissue adhesive to seal the wound.~   "
112344|NCT02096978|"~     The study will be conducted to compare two alternative techniques for dental implant~     placement. Both of the techniques - Osteotome and Conventional Drilling Techniques for the~     preparation of the implant sites (osteotomies) are accepted standards of care. The goal of~     the study will be to compare implant stabilities achieved with two techniques by measuring~     resonance frequency for each implant placed using the diagnostic device, the Osstell machine,~     that measures stiffness of the bone/implant system non-invasively. The data are represented~     in a quantitative value - implant stability quotient (ISQ), where a higher value indicated a~     higher implant stability. Since it has been well documented in the scientific literature that~     primary (at the time of implant placement) implant stability is a strong prerequisite for~     implant success (osseointegration and subsequent function on loading), the results of this~     study will guide the implant team in choosing the right surgical treatment protocol - the~     protocol that will be aimed for higher implant stability, and, therefore, for higher~     long-term implant success.~   "
112345|NCT02096965|"~     In this study the investigators propose to use a daily dose of 45 mg (30 mg at 8 AM and 15 mg~     at 4 PM). This relatively small well-tolerated dose is likely to persistently increase urine~     volume and reduce urine supersaturation and to be well tolerated by patients with kidney~     stone disease and normal renal function (see below). The twice-daily (8 AM and 4 PM) regimen~     is designed to produce a maximal AVP inhibition on waking with a gradual fall-off of effect~     during the night. To this end, a higher dose is used in the morning, with a lower dose in the~     afternoon.~   "
112346|NCT02096952|"~     The purpose of this study is to determine whether methylphenidate hydrochloride extended~     release liquid formulation is safe and effective in the treatment of~     attention-deficit/hyperactivity disorder (ADHD) in high-functioning adults with autism~     spectrum disorders (ASD).~   "
112347|NCT02096939|"~     Patients with primary aldosteronism, which is the most prevalent form of secondary~     hypertension, have an increased rate of cardiovascular events, compared to patients with~     essential hypertension, even with equal severity of hypertension. This might be partially~     attributed to the association of increased aldosterone levels with insulin resistance. How~     this relation can be explained from a pathophysiological point of view, is insufficiently~     established.~      Recently, microvascular dysfunction has been proposed as a link between insulin resistance~     and hypertension. Loss of NO-mediated vasodilation is an important feature of microvascular~     dysfunction; in addition, an impaired insulin-mediated microvascular NO production has been~     suggested to underlie the reduction in insulin-stimulated glucose disposal that is~     characteristic of insulin-resistant states. Increased aldosterone levels are not only~     associated with insulin resistance, but also with endothelial dysfunction. In addition, they~     interfere with the vascular effects of insulin.~      Therefore, the investigators hypothesize that in patients with primary aldosteronism,~     increased aldosterone levels induce microvascular dysfunction through reduction of~     NO-availability, which contributes to the development of insulin resistance, and of~     hypertension, in addition to the sodium-retaining effects of aldosterone.~   "
112348|NCT02096926|"~     This is a single center placebo controlled, prospective, randomized study on healthy adults~     undergoing third molar surgery.~   "
112349|NCT02096913|"~     The Ibuprofen - Spinal Cord Injury (SCI) - Safety trial investigates tolerability and~     feasibility of small molecule (Ibuprofen) mediated Rho-inhibition as putative~     neuroprotective, plasticity-enhancing and neurorestaurative intervention. The primary safety~     analysis is based on the incidence of severe gastrointestinal bleedings. In addition, the~     feasibility of recruitment procedure, and oral administration of the compound within the~     multidisciplinary setting of acute intensive medical care will be explored. Furthermore, the~     pharmacokinetics of Ibuprofen under the condition of acute motor complete SCI will be~     investigated. Secondary endpoints will permit preliminary statements about effects on~     neuropathic pain, spasticity, and neurological function.~   "
112350|NCT02096900|"~     The purpose of this investigator-initiated study is to compare the efficacy of oral midazolam~     and zolpidem for preoperative sedation, anxiety of patient, and caregiver anxiety at the time~     of separation, and ease of mask acceptance at induction in children. Subjects will be~     randomized to receive oral medication midazolam or zolpidem approximately 30 minutes prior to~     surgery. No placebo will be administered in this study. Subjects will be male and female~     children between 2 and 9 years of age. In total, subject participation will last~     approximately the duration of their preoperative, perioperative, and immediate postoperative~     period. A member of the research team will recruit subjects preoperatively in the operating~     room holding area prior to surgery. Consent will take place at the time of recruitment in the~     preoperative holding area following a detailed explanation of the study and medications~     involved in the study. Participants will be of ASA (American Society of Anesthesiologists)~     class I-II, undergoing surgical procedures of at least 2 hours duration, and expected to~     remain inpatient for at least 23 hours postoperatively.~   "
112351|NCT02096887|"~     Patient's awareness of their risk factors for heart disease and their active involvement in~     their own management plan can help improve their adherence to treatment and their risk~     profile. The purpose of this study is to investigate the influence of patient education and~     awareness of heart disease risk factors on compliance to medication and lifestyle~     modification.~   "
112352|NCT02096874|"~     Ultra-wide field fluorescein angiography can detect the response of anti VGEF therapy such as~     Avastin on retinal ischemia in the setting of diabetic macular edema.~   "
112353|NCT02096861|"~     This study is to assess noninferiority in efficacy and to assess overall safety of CT P13~     compared to Remicade in patients with active Crohn's disease up to Week 54.~   "
112363|NCT02096718|"~     The primary objective of the current study is to investigate the influence of moderate to~     severe renal impairment on the pharmacokinetics and safety of a single dose afatinib in~     comparison to a control group with normal renal function.~      The assessment of safety and tolerability will be an additional objective of this trial and~     will be evaluated by descriptive statistics.~   "
112364|NCT02096705|"~     The purpose is to determine if after 24 weeks of oral daily administration, there will be a~     greater mean reduction from baseline in glycosylated hemoglobin (HbA1c) achieved with~     Dapagliflozin 10 mg plus insulin compared to placebo plus insulin in subjects with type 2~     diabetes.~   "
112365|NCT02096692|"~     The objective of the ProMRI Study is to demonstrate the clinical safety of the ProMRI ICD~     System when used under specific MRI conditions.~   "
112354|NCT02096848|"~     Studies which describe the bacterial aetiology and antimicrobial susceptibility in AOM~     children in Latin America are scarce. Interestingly, when the MEF microbiology was analyzed~     among 1,108 children aged 2-92 months with OM between years 2002 and 2007, non-typable H.~     influenzae was the most common pathogen isolated from the MEF of children with a otitis media~     failing to appropriate antimicrobial therapy.~      PCV-7 (3 + 1 regimen) was introduced into the Costa Rican national immunization program in~     January 2009 and in August/September of 2011, it was changed for PCV 13 (-2+1 regimen).~     Following PCV-7 universal introduction in Costa Rica, between March of 2010 and January of~     2011, MEF samples from Costa Rican children with OM, having received 0-4 PCV 7 vaccine doses,~     were obtained via tympanocentesis (88%) or from spontaneous otorrhoea (12%). It was~     interesting to observed that among the initial 134 OM episodes, the most common bacterial~     pathogen identified was H. influenzae (55%) followed by S. pneumoniae (31%) and that among~     the S. pneumoniae episodes, 55% were already non-PCV-7 serotypes and that 25% of these~     isolates were multi-drug resistant.~      The primary objectives of the study are to analyze the effect of early universal utilization~     of PCV-13 in Costa Rican children with the number of H. influenzae and PCV-13- S. pneumoniae~     positive MEF cultures by comparing the data collected prospectively and by the same group of~     investigators that have collected the original data since 1992, from children for the~     post-PCV-13 introduction with anonymised information collected retrospectively pre-PCV-7 data~     (1999-2004) during a transition period in which PCV-7 was used in only the private settings~     (2005-2008) and during universal use of PCV-7 (2009-September 2011).~   "
112355|NCT02096835|"~     The purpose of this study is to access the effect of TEAS of P6 in the prevention of PONV in~     women scheduled for gynecologic laparoscopic surgery with general anesthesia.~   "
112356|NCT02096822|"~     Preterm infants undergo very frequent painful procedures during neonatal care particularly~     during the first few days. The support for the pain of the preterm is a priority for nurses~     and neonatologists. Previous studies showed that non-nutritive sucking combined with sucrose~     ensures effective pain-relief for preterm (28-32 weeks GA). Unfortunately, the use of sucrose~     is limited to 4 administrations per day which is insufficient compared to the average of~     daily painful procedures. So, validation of an effective non-pharmacological intervention to~     relieve or avoid pain is essential. Facilitated tucking alone has been validated for preterm~     less than 37 GA during heel stick procedure with the PIPP score but no study looks for the~     benefit for pain relief of the association of non-nutritive sucking and facilitated tucking~     during heel stick procedure.~   "
112357|NCT02096809|"~     Objectives~        -  To evaluate the safety of processor loading of the Cochlear BI300/BA400 implant system 1~          week after implantation~        -  To evaluate the short term soft tissue healing and the long term skin reaction, with the~          new Cochlear BI300/BA400 implant system using the linear incision without subcutaneous~          tissue reduction.~        -  To produce reference data regarding the stability of the BI300/BA400 implant system.~      Study design: Prospective cohort study. Patients: 24 adults with anticipated normal skin and~     bone quality eligible for bone anchored implant surgery.~      Intervention: Loading of the sound processor one week after surgery Main outcome measures:~     Implant stability, soft tissue reaction, skin overgrowth, pain and numbness will be assessed.~      It is hypothesized that implant loading can be performed one week after surgery without any~     changes in implant stability, soft tissue reaction, skin overgrowth, pain or numbness around~     implant.~   "
112358|NCT02096796|"~     Arm Pump is a sport specific term drivers use to describe Acute or Chronic Compartment~     Syndrome of the forearm. Drivers experience pain in the forearms due to increased blood~     pressure in forearm muscle compartments. No strategies nor methods have been used to diminish~     the risk to suffer from arm pump within motor cross.~      This project aims to look at ergonomics of driving and its relationship with the occurrence~     of arm pump.~      The investigators will first investigate the experience of motor cross athletes with arm pump~     through motor cross federations in Belgium and The Netherlands (survey).~      Two groups of athletes will be selected (20 persons within each group) who will be invited to~     the motor cross track to investigate their hand grip strength, motor driving position, muscle~     activity.~   "
112359|NCT02096783|"~     This randomized pilot clinical trial studies the feasibility of a pre-operative and/or~     post-operative scripted sexual health informational intervention and how well it works in~     improving sexual function in patients with gynecologic cancer. Discussing sexual outcomes and~     counseling options with patients may help improve sexual outcomes and/or anxiety after~     primary gynecologic cancer treatment.~   "
112360|NCT02096757|"~     Investigators hypothesize that high-dose n-3 polyunsaturated fatty acids (PUFA) oral~     supplementation will improve will improve systemic inflammation and patency of peripheral~     vascular intervention (PVI).~   "
112361|NCT02096744|"~     To establish the bioequivalence and adhesion properties of transdermal clonidine prepared~     with Oppanol® brands of polyisobutylene (PIB) vs. transdermal clonidine prepared with~     VistanexTM brands of polyisobutylene (PIB) in healthy male and female volunteers.~   "
112362|NCT02096731|"~     Background: Recent observational studies have reported possible arrhythmogenic effects with~     long-acting beta-agonists (LABA), while the long-acting anticholinergic tiotropium has been~     associated with cardiovascular and cerebrovascular events. Finally, pneumonia was the object~     of a recent signal in trials of LABAs submitted for marketing approval.~      Aim: To assess the potential cardio-pulmonary risk arising from the concurrent use of two~     long-acting bronchodilators as well as from monotherapy use of each of the long-acting~     bronchodilators.~      Methods: A series of population-based cohort studies, using both cohort and nested~     case-control analyses will be conducted using data from the United Kingdom's Clinical~     Practice Research Datalink (CPRD). The base cohort will consist of new users of long-acting~     bronchodilators from Jan 2002 until Aug 2012, age >= 55 with chronic obstructive pulmonary~     disease (COPD) and at least two years of baseline medical history information. The~     high-dimensional propensity score technique will be used to match new users of each~     long-acting bronchodilator and new users of two bronchodilators with comparable subjects from~     the base cohort, with one-year follow-up for outcomes of acute myocardial infarction, stroke,~     heart failure, arrhythmia and community acquired pneumonia. Data will be analysed using~     time-dependent Cox proportional hazard regression models and conditional logistic regression~     models.~   "
112366|NCT02096679|"~     Study to evaluate the pharmacokinetic and Mass Balance of single dose [14C] AZD9291 in~     healthy male volunteers~   "
112368|NCT02096653|"~     In this study, the investigators are attempting to determine whether intra- or~     extra-articular injections are more effective; the relative prevalence rate of~     intra-articular and extra-articular SI joint pain; and the accuracy of extra-articular~     injections using fluoroscopy as the reference standard. 124 consecutive patients with~     mechanical low back pain below L5, tenderness overlying the SI joint(s) and at least 3~     positive provocative maneuvers will be randomized to receive SI joint injections by 2~     different approaches.~      Group 1 will receive fluoroscopically-guided injections into the joint. Group 2 will receive~     landmark-guided injections into the tender area around the joint. In order to determine~     whether the injection in group 2 was intra-articular or extra-articular, an x-ray will be~     done after the injection to ascertain the location of contrast spread. The primary outcome~     measure will be pain relief at 1-month. Patients who obtain benefit at 1-month will be~     followed at 3-months, while those who fail to obtain benefit will exit the study to receive~     alternative care.~   "
112369|NCT02096640|"~     The main purpose of this study is to examine if there are differences in postoperative~     inflammation following percutaneous dilatation tracheostomy versus surgical tracheostomy in~     intensive care unit patients.~   "
112370|NCT02096627|"~     In this project, the investigators aim to compare the safety, efficacy, and predictability~     outcomes of conventional CEIOL surgery to Femtosecond-laser-assisted CEIOL (FLACS) in an~     effort to improve cataract surgery outcomes. The investigators hypothesis is that FLACS may~     lead to preservation of endothelial cells compared to conventional CE IOL.~   "
112371|NCT02096614|"~     Following pre-treatment with cyclophosphamide and/or fludarabine, MAGE-A4-specific TCR gene~     transduced T lymphocytes are transferred to the patients with MAGE-A4-expressing solid~     tumors.~   "
112372|NCT02096601|"~     An open label phase I/IIa study to evaluate the safety and tolerability of 6 different doses/~     infusion rates of subcutaneous (SC) ND0612 solution in PD patients; to determine if~     continuous delivery of levodopa and carbidopa can provide reduced variability in plasma~     concentration; to test and compare the PK profile of high and low concentrations of CD; to~     assess preliminary efficacy.~   "
112373|NCT02096588|"~     Doxorubicin (Adriamycin), one of the drugs commonly used for the treatment of breast cancer,~     is in a class of medications called anthracyclines. Anthracyclines may cause heart damage~     that can lead to weakening of the heart muscle. This heart damage may happen right away or~     may occur many years after the anthracycline is given~      Simvastatin is an oral medication approved by the FDA to lower cholesterol. Simvastatin is in~     a class of medications called statins. Some research has shown that statins may prevent heart~     damage that can be caused by anthracyclines like Doxorubicin (Adriamycin).~      The purpose of this study is to determine if taking simvastatin while receiving the~     chemotherapy Doxorubicin (Adriamycin) will minimize damage to the heart.~      This study is for women who will be receiving the anthracycline doxorubicin (Adriamycin) as~     part of their breast cancer treatment.~   "
112374|NCT02096575|"~     The purpose of this research is to study the effect of nitrous oxide on pain felt by women~     having a surgical termination at less than 11 weeks compared to pain felt by women receiving~     oral pain medications.~   "
112375|NCT02096562|"~     Outpatients who undergo knee surgery are designated two different clinical study groups.~     Group A receives common wrapping after surgery to the first postsurgical day and will be~     provided with compression stockings for the following 10 days, while group B only receives~     common wrapping and will not be provided with compression stockings.~      The investigators are going to investigate the effect of compression stockings on~     postsurgical swelling and formation of edema on outpatients.~   "
112376|NCT02096549|"~     During Intramuscular botulinum toxin injections for children with cerebral palsy, immobility~     is essential to inject botulinum toxin to the right muscle. Because children with cerebral~     palsy are generally unable to control their movement, deep sedation is required during this~     painful procedure.~      Short-acting drugs such as propofol and remifentanil are widely used for pediatric anesthesia~     and sedation but still have possibility of over-sedation and associated complications due to~     their rather narrow therapeutic window. Therefore, objective scoring system to assess the~     level of sedation to provide an effective and safe sedation in children. Bispectral index~     (BIS) monitoring,an objective guidance of sedation might be helpful.~      The present study is to investigate the validity of the BIS monitoring during deep sedation~     of children with cerebral palsy for injection of botulinum toxin.~   "
112377|NCT02096536|"~     Vancomycin is already used for decades in neonates. However, there are remaining questions~     concerning vancomycin disposition in this population. The purpose of this study is first of~     all to perform a paired analysis of serum vancomycin concentrations using an immunoassay~     versus a reference liquid chromatography-tandem mass spectrometry method. Secondly, we aim to~     determine vancomycin protein binding and its covariates in neonates.~   "
112378|NCT02096523|"~     The goal of this study is to identify the platelet defect responsible for the bleeding in~     families from our inherited platelet disorders Israeli-Palestinian registry. The~     investigators plan to characterize platelet proteome expression after removing high abundance~     proteins. The investigators will compare the proteome of sick and healthy members of families~     with inherited platelet disorders, and identify and validate structural proteins, signaling~     cascades and biomarkers for detection and diagnosis of unknown platelet disorders. The~     investigators expect to discover new key findings that allow better understanding of human~     platelet function and allow better diagnosis and treatment of patients with inherited~     platelet function disorders.~   "
112379|NCT02096510|"~     The aim of this study is to compare the effects of tablet treatment, circadian and combined~     circadian and ultradian subcutaneous hydrocortisone infusion on steroid metabolism and tissue~     responses to therapy.~   "
112380|NCT02096497|"~     Retrospective analysis to the course and branching pattern as well as surgically relevant~     inner diameters and lengths of the superficial temporal artery (STA) by digital subtraction~     angiographies (DSA).~   "
112381|NCT02096484|"~     The study will examine the effectiveness of group metacognitive therapy in comparison with~     group meditation therapy, in patients with Generalised Anxiety Disorder. Individuals will be~     randomly assigned to either meditation or metacognitive therapy and undergo 8 group therapy~     sessions of their respective treatment condition.~   "
112382|NCT02096471|"~     This phase II open label study will evaluate adolescents (≥ 16 years of age) and adults with~     neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with the MEK inhibitor~     PD-0325901. The primary aim of the study will be to assess quantitative radiographic response~     in a target lesion. Subjects will receive PD-0325901 by mouth on a bid dosing schedule of 2~     mg/m2/dose with a maximum dose of 4 mg bid. Each course is 4 weeks duration, and subjects~     will receive drug on a 3 week on/1 week off schedule. Subjects may receive additional courses~     beyond course 8 only if there is at least 15% reduction in volume of the target tumor.~     Subjects who have a 20% or greater reduction in target tumor volume at the end of 12 courses~     can continue on therapy for up to an additional year (maximum of 24 total courses). However,~     subjects who do not achieve at least 15% reduction in volume of the target tumor after 8~     courses (~8 months) will be considered treatment failures and taken off study.~      The Primary purpose of this protocol is to determine whether PD-0325901 results in objective~     radiographic responses based on volumetric MRI measurements in adolescents and adults with~     NF1 and growing or symptomatic inoperable PN.~      There are several secondary aims of this protocol:~      To evaluate the feasibility and toxicity of chronic PD-0325901 administration in this patient~     population~      To estimate the objective response rate of up to 2 non-target plexiform neurofibromas to~     PD-0325901by MRI~      To characterize the pharmacokinetic profile of PD-0325901 when administered to this patient~     population~      To characterize the pharmacodynamic profile of PD-0325901 when administered to this patient~     population using dermal neurofibromas as a surrogate for plexiform neurofibroma cells~      To characterize the activity of PD-0325901 on neurofibroma cell gene expression~      To characterize the activity of PD-0325901 on plasma cytokines and growth factors~      To correlate pERK levels to pharmacokinetic data and response~      To evaluate quality of life and pain during treatment with PD-0325901~      To validate the PedsQL NF1 QOL Module, a disease specific QOL scale, for use in this patient~     population, and~      To determine whether subjects who respond (≥20% objective radiographic response of target~     lesion by 12 courses) to PD-0325901 will maintain that response for 1 year one they come off~     therapy~   "
112383|NCT02096458|"~     The purpose of this study is to measure the in-vivo disintegration time of a single~     dexlansoprazole delayed-release orally disintegrating (OD) tablet.~   "
112384|NCT02096445|"~     The aim of this project is to clinically evaluate a novel robot-assisted therapeutic approach~     to train sensorimotor hand function after stroke. It combines the profound experience of the~     clinic Hildebrand in neurocognitive therapy - involving brain and mind in the task and~     training both the motor and the sensory system - with the advanced haptic robotic technology~     of the Rehabilitation Engineering Lab at the Swiss Federal Institute of Technology Zurich~     (ETH Zurich), allowing unmet interaction with the hand through the simulation of virtual~     objects with various mechanical properties. In a randomized controlled clinical trial, 10~     sub-acute stroke patients will receive four weeks of robotic therapy sessions, integrated~     seamlessly into their daily rehabilitation program, while 10 other patients will receive~     conventional therapy. The investigators will assess baseline performance in an initial~     clinical and robotic assessment, with another assessment at the end of the four-week period,~     and in follow-ups four weeks and six months later. The contents of the patient-tailored~     robotic therapy sessions will match those of the conventional therapy as closely as possible.~     This study will demonstrate the feasibility of including robotic therapy of hand function~     into the daily rehabilitation program, and investigate the acceptance from patients and~     therapists. The investigators expect increased training intensity during the robotic therapy~     session compared to conventional sessions with similar contents, as well as novel insights~     into the recovery process of both the motor and the sensory system during the four weeks of~     therapy, through advanced robotic assessments integrated into the training sessions. This~     project is a first step towards making such robotic therapy available to patients as~     integration into the conventional individual therapy program (e.g. for self-training), and~     towards transferring this technology to the home environment.~   "
112385|NCT02096432|"~     This project aims to develop and refine a suicide intervention protocol, and pilot test a~     culturally tailored randomized control trial to reduce suicidal thoughts among U.S. Chinese~     older adults. During the first phase of the study, the investigators plan to invite the~     community advisory board and key stakeholders to participate in the iterative design and~     refinement of the study protocol. During the second phase of the project and after the~     initial screening and based on a specific set of inclusion criteria, the investigators will~     invite U.S. Chinese older adult to participate in a pilot randomized control trial of a~     culturally adapted intervention to reduce the frequency and intensity of suicidal thoughts in~     Chinese older adults. During the third phase of the project, the investigators plan to invite~     pilot intervention participants as well as key stakeholders and health care professionals on~     the cultural acceptability of the pilot intervention. Through the achievement of these~     objectives, the investigators will set the foundation to fully test a culturally adapted~     in-home intervention, which may be particularly suitable for Chinese older adults with~     suicidal thoughts as it addresses cultural-specific barriers and integrates care management~     within existing community services agencies using non-mental health professionals, including~     community health workers.~   "
112386|NCT02096419|"~     The purpose of this study is to determine whether continuous clopidogrel dose adjustment~     targeted after platelet function testing improves outcomes during 12 months of follow-up in~     acute coronary syndrome patients treated with coronary artery stenting and with determined~     high platelet reactivity on clopidogrel.~   "
112387|NCT02096406|"~     Coronary artery disease is a leading cause of death, hospitalization, and health care costs~     in developed nations. Coronary revascularization with coronary artery bypass graft (CABG)~     surgery improves the long term survival in patients with diabetes and multi-vessel disease.~     Angiotensin converting enzyme inhibitors (ACE) and angiotensin receptor blockers (ARB) reduce~     mortality and subsequent cardiac events in patients with coronary artery disease undergoing~     CABG surgery when initiated at least 4 weeks pre-operatively. Observational data have~     suggested that pre-operative ACE administration is associated with an increased risk of~     post-operative vasoplegic shock, acute kidney injury, and mortality; however, other studies~     have failed to confirm these findings and further suggested ACE are associated with a reduced~     risk of peri-operative myocardial infarction. A single trial of 40 CABG patients randomized~     to pre-operative ACE withdrawal or continuation reported that the withdrawal group required~     significantly fewer vasopressors during cardiopulmonary bypass but more intravenous~     vasodilators post-operatively to control hypertension. Hence, it remains unclear whether ACEs~     should be held or continued immediately prior to CABG surgery and a survey of cardiac~     surgeons suggests that current clinical practice is divided. This pilot study aims to~     establish the feasibility of the study design and to determine the frequency of clinical~     endpoints among patients who continue and discontinue ACE prior to cardiac surgery.~   "
112388|NCT02096393|"~     This is a randomised control trial to assess the benefits of using patient specific~     instrumentation in total knee replacement surgery. Patient specific instrumentation is an~     individualised system for total knee replacement surgery. The system has been marketed and is~     already in use in some centres. The type of implant used remains the same but the sizing of~     the components, and alignment of the implant is expected to improve. This study assesses any~     improvement in implant alignment in using the patient specific instrumentation, any improved~     intra-operative outcomes and any long term clinical outcome improvements for patients.~   "
112389|NCT02096380|"~     Two Phase Ⅲ trials (TAX323 and TAX324) showed induction chemotherapy adding docetaxel to~     cisplatin plus fluorouracil (TPF) could significant improve survival in head and neck cancer,~     and a Phase Ⅱ trial from Hong Kong by Hui and colleges with this strategy has also been~     reported in nasopharyngeal carcinoma (NPC). However, whether three cycles induction could~     delay the whole time of treatment and reduce the survival benefit are still unknown. A~     retrospective study of one cycle TPF induction chemotherapy by the investigators group (not~     yet published) could improve survival in NPC. It encourage us to conduct this clinical trial.~   "
112390|NCT02096367|"~     Balance disorders are very common after strokes and often last for long periods of time.~     Their origin is multifactorial and their impact on the daily lives of patients are~     particularly important, especially on gait.~      The vibration technology for rehabilitation was already studied in static posture with force~     plats but their impact on gait have yet to be evaluated.~      This present study aims at investigating the effects of vibrations applied by an approved~     medical device to the posterior neck muscles and the gluteus medius - major actors of~     proprioception and posture mechanisms - on gait disorders in patients with hemiplegia during~     the chronic phase after stroke.~   "
112391|NCT02096354|"~     This two-stage study is designed to compare the safety and activity between RRx-001 against~     regorafenib followed by irinotecan-based therapies in a parallel comparative study.~      Patients who are suffering from advanced or metastatic (meaning the disease has spread)~     colorectal cancer are invited to participate in this study. There will be two groups of~     patients (Randomized, open label study), one of these will receive RRx-001 and the other one~     will receive regorafenib. If patients qualify to participate in this study, they will be~     randomly assigned to the 'interventional arm' where patients will receive the experimental~     drug, RRx-001, or the 'control arm' where they will receive the current standard-of-care,~     Regorafenib. Patients have a 66% chance (2 out of 3) of receiving RRx-001 and a 33 % chance~     (1 out of 3) of receiving regorafenib.~      On progression in the first part of the study, provided ECOG performance status is adequate,~     and if clinically appropriate i.e. there are no absolute or relative contraindications in the~     opinion of the Investigator, all subjects will enter the second part of the study and receive~     irinotecan plus bevacizumab.~      Whether patients are given RRx-001 or regorafenib, they will also receive best supportive~     care, which includes treatments to help manage side effects and symptoms of cancer. This is~     an open label study, which means patients will know to which of these treatments, RRx-001 or~     regorafenib, they are assigned.~   "
112392|NCT02096341|"~     To investigate the dosage of RRx-001 by the subcutaneous route.~   "
112393|NCT02096328|"~     To investigate the pharmacokinetic characteristics of POL7080 co-administered with SoC during~     10 to 14 days of treatment in VAP patients due to suspected or documented Pseudomonas~     aeruginosa infection~   "
112394|NCT02096315|"~     To test whether POL7080 is effective in patients with exacerbation of non-cystic fibrosis~     bronchiectasis caused by Pseudomonas aeruginosa infection.~   "
112395|NCT02096302|"~     The purpose of this study is to determine whether an infant formula supplemented with a new~     probiotic CECT7210, is effective in reducing the incidence of infections, specially the~     gastrointestinal ones.~   "
112396|NCT02096289|"~     This is a Phase I trial investigating the safety of using thioridazine in addition to~     cytarabine in elderly patients with relapsed or refractory Acute Myeloid Leukemia.~   "
112397|NCT02096276|"~     The purpose of this Registry is to detect and describe any abnormal pregnancy outcomes,~     including teratogenicity, in females intentionally or unintentionally exposed to Boostrix~     during their pregnancies in the US. The Registry requires voluntary, prospective reporting of~     eligible pregnancies by patients and health care providers (HCPs). Data such as vaccination~     with Boostrix during pregnancy or within 28 days preceding conception, potential confounding~     factors (such as exposure to other medications) and information related to the outcome of the~     pregnancy will be collected prospectively~   "
112398|NCT02096263|"~     The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals'~     Infanrix hexa vaccine when administered to healthy infants as primary vaccination at 2, 4 and~     6 months of age, co-administered with Prevnar and Rotarix with a booster dose of GSK~     Biologicals' Infanrix and Hiberix vaccines at 15-18 months of age.~   "
112399|NCT02096250|"~     The government of Haiti plans to introduce a flour fortification program. The aim of the~     project it to inform the authorities on the most suitable iron compound for this~     fortification program. For this purpose, iron absorption from wheat flour using different~     iron compounds will be investigated.~   "
112400|NCT02096237|"~     In this study patients suffering from Immunoglobulin E (IgE) mediated asthma are treated with~     a method, called immune apheresis, that removes IgE from blood. In order to achieve this~     blood is taken continuously from the patient and then separated into plasma and blood cells~     by centrifuge. The plasma passes the new IgE adsorber where the IgE is specifically bound.~     The cleaned plasma re-joined with the blood cells is given back to the patient. In total~     each patient randomized to the apheresis group will undergo 3 treatments per week (i.e. 1~     cycle) every 4 weeks over a time period of 3 months, that means 9 apheresis treatments in 3~     cycles in total. Study hypothesis is that the new IgE adsorber is capable of reducing IgE in~     plasma/serum by at least 50% measured before the first treatment in the first cycle and after~     the last treatment in the last treatment cycle. The new adsorber can be safely used in~     patients. A group of patients with conventional drug treatment and no apheresis treatment~     serves as control.~   "
112401|NCT02096224|"~     We want to evaluate the efficacy of the sevoflurane and desflurane for the prevention of~     catheter-related bladder discomfort.~   "
112402|NCT02096211|"~     This study is intended to gather short (Pre-operative to 4-years) and mid-term (5-years)~     information regarding the performance and safety of the commercially available 36mm CERAMAX®~     Ceramic on Ceramic Total Hip System from a cohort of new study subjects that were not~     previously involved in the IDE study for this device.~   "
112403|NCT02096198|"~     This study is intended to gather medium (5- to 7-years) and long-term (minimum 8- to~     10-years) information regarding the performance and safety of the commercially available 36mm~     CERAMAX® Ceramic on Ceramic (COC) Total Hip System from a cohort of study subjects that were~     previously enrolled in the IDE study. (COC = 36mm ceramic acetabular bearing insert component~     that articulates with a ceramic femoral head in the COC total hip replacement system)~   "
112424|NCT02095925|"~     Cancer patients are at increased risk of deep venous thrombosis and pulmonary embolism,~     collectively termed venous thromboembolism (VTE). Risk assessment scores for VTE in cancer~     patients have been previously developed by the groups of Khorana and Vienna CATS. However,~     routine thromboprophylaxis for ambulatory cancer patients based on these scores is currently~     not recommended. In the investigators prospective, observational cohort study, the~     investigators aim to identify cancer patients at high risk for VTE based on clinical~     characteristics, coagulation biomarkers and the coagulant activity of tissue factor bearing~     microparticles.~   "
112404|NCT02096185|"~     Patients who are diagnosed with breast cancer will have surgery to remove the tumour. Where~     this is a local excision not mastectomy, the tissue removed is sent for x-ray imaging to~     assess that the abnormality has been removed and give an estimation of the distance from~     lesion to specimen edge. This allows the surgeon to decide whether to remove more tissue or~     not at the time. This study is designed to compare whether more accurate information about~     lesion to margin measurement can be obtained using 3 dimensional tomosynthesis imaging~     compared to 2 dimensional conventional digital imaging which is the type of imaging currently~     used. This has the potential to prevent some patients requiring a second operation to remove~     more tissue if the margins of the specimen are still involved with tumour.~      The study involves x-raying the specimen under both conditions when it arrives from theatre.~     Only the 2D image will be reviewed at the time as is current practice. The 3D image will be~     reviewed later and the measurements for lesion to specimen margin compared. The lesion to~     margin measurement as recorded by the pathologist will be taken as the 'gold standard' and~     the imaging measurements will also be compared to that.~      In theory, the use of 3D tomosynthesis should allow more accurate lesion to margin~     measurement because 3D can provide better visualisation of the lesion edges by removing the~     effect of superimposed tissue.~      The hypothesis states that the use of 3 dimensional tomosynthesis imaging should provide~     better lesion visualisation compared to 2 dimensional conventional digital imaging thus~     allowing more accurate lesion to margin measurement.~   "
112405|NCT02096172|"~     The objective of this study is to evaluate the impact of pharmacogenomic aspects of drug~     metabolism on the measurement of drug and drug metabolites on urine drug testing (UDT).~   "
112406|NCT02096159|"~     The primary purpose of this study is to determine if routine use of prophylactic (preventive)~     antibiotics after repair of mid-to-distal hypospadias is beneficial.~   "
112407|NCT02096146|"~     This study will compare TMT Fusion Plate versus two crossed screws for the fixation of first~     tarsometatarsal joint arthrodesis. Patients who meet eligibility criteria will be randomly~     assigned to one of these two treatment options.~   "
112408|NCT02096133|"~     Patients with multiple sclerosis (MS) have an increased risk of developing a major~     depression. The investigators observed a protective effect of high vitamin D levels on the~     risk of depression in MS. This might be driven by the effect of vitamin D on the stress-axis.~     Therefore, the main goal of the present study is to assess whether high dose vitamin D~     supplementation results in a suppression of the stress-axis, as measured by decreased levels~     of cortisol.~   "
112409|NCT02096120|"~     The purpose of this study is to determine whether full mouth disinfection in combination with~     one week antibiotic amoxicillin plus metronidazole antibiotic therapy is improving~     periodontitis and disease activity of rheumatoid arthritis.~   "
112410|NCT02096107|"~     Transition from tacrolimus based triple therapy with Mycophenolate Mofetil (MMF) and steroids~     in stable renal transplant patients to low intensity tacrolimus, everolimus and prednisone~     will be associated with improvement in Glomular Filtration Rate (GFR) and allograft fibrosis.~   "
112411|NCT02096094|"~     Traditional bed bathing have been related to cross-infection. In order to avoid this~     complication, single-use products such as wipes impregnated with chlorhexidine use is~     increasing. Nevertheless among nursery staff concern about its side effects prevents its~     widespread use. The investigators want to know if there are any differences between the use~     of 2% chlorhexidine wipes and a placebo concerning side effects.~   "
112412|NCT02096081|"~     The purpose of this study is to show that two FDA-approved botulinum toxin drugs called~     Xeomin® and Botox® can reduce the severity of vertical lines (wrinkles) that appear between~     the eyebrows (glabellar frown lines).~   "
112413|NCT02096068|"~     The drug Dexmedetomidine will be investigated in 72 patients (men and women) undergoing~     elective cardiac or abdominal surgery. The study medication will be administered~     perioperatively by intravenous infusion continuously (at the longest 48 h) to prevent/reduce~     the rate of Delirium and the incidence of postoperative cognitive deficit (POCD).~      A non-surgical control group of 15 ASA II/III- patients from Berlin and surrounding area is~     collected for measuring the learning experience during the cognitive testings. The~     participants are matched on age, education, and gender to the study patients.~      Cognitive testings are performed in patients of the study group (n= 72) and the control group~     (n= 15) to evaluate deficits in their cognitive areas (POCD (Postoperative cognitive~     deficit)) at three different time points up to three months.~   "
112414|NCT02096055|"~     The goal of this clinical research study is to compare different treatment schedules using~     the drug SGI-110 alone or in combination with other drugs. Researchers want to learn more~     about how these different treatment schedules may help to control AML. The safety of these~     treatments will also be studied.~   "
112415|NCT02096042|"~     This clinical research study is made up of 3 phases: a Pilot Phase, Phase 1, and Phase 2.~      The goal of the Pilot Phase is to learn how safe it is to give the study drug brentuximab~     vedotin to patients with AML. The goal of Phase 1 is to learn more about the safety of the~     combination of brentuximab vedotin with azacytidine. The goal of Phase 2 is to learn if the~     combination of brentuximab vedotin and azacytidine can help to control AML.~   "
112416|NCT02096029|"~     The purpose of this study is to evaluate the use of sampling of smoking cessation~     medications (nicotine patches and lozenges) among smokers seen in primary care settings. Half~     of study participants will be provided with samples of medication, to use however they wish;~     the other half will not be provided with these samples. All smokers will be advised to quit~     through routine contact with their physician. After the primary care contact, all~     participants will be contacted by phone for three brief follow-up interviews, which will~     involve answering questionnaires about their smoking habits.~   "
112417|NCT02096016|"~     The investigators have planned this project to evaluate the follow-up program after surgery~     due to cervical cancer and to explore the possibilities for different tests of Human~     Papilloma Virus (HPV) in contributing to the customization of the follow-up program.~      Purpose:~      The investigators effort is to provide the background for an evidence-based update of the~     follow-up program after surgery due to cervical cancer with the purpose of early diagnosis of~     recurrence affecting quality of life for as few women as possible.~   "
112425|NCT02095912|"~     To identify risk factors for aggressiveness in Squamous Cell Carcinoma of the skin in organ~     transplant recipients.~   "
112418|NCT02096003|"~     The use of intrathecal opioids for analgesia in the setting of cesarean section has become~     standard obstetric anesthesia practice. Currently, two opioids are commonly used. These~     opioids are fentanyl and morphine (Duramorph). Intrathecal opioids are an excellent source of~     analgesia and act to reduce the stress response to surgery.~      Currently, most obstetric anesthesiologists use intrathecal morphine for analgesia after~     cesarean delivery. Morphine provides excellent analgesia for cesarean section. However, use~     of this medication is associated with side effects such as pruritus and nausea and vomiting.~      Recently, multiple obstetric anesthesia groups began to use intrathecal hydromorphone for~     cesarean delivery when morphine was unavailable. As groups began to use hydromorphone,~     retrospective data became available that demonstrated its safety and efficacy for use during~     cesarean section.~      In order to fully elucidate the analgesic and side effect properties of hydromorphone for~     cesarean delivery, a prospective randomized, double blind study comparing morphine and~     hydromorphone is necessary. The investigators need to understand whether hydromorphone is as~     effective as morphine for analgesia after cesarean section, and whether it is associated with~     fewer or more side effects. The results of the study will allow providers to make educated~     decisions to better care for their patient.~   "
112419|NCT02095990|"~     To assess the ability of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) to reduce~     melasma on the face, using a split-face randomization design, evaluating the MASI Score from~     baseline to week 4 and week 8, in both half-faces receiving active treatment vs. placebo.~      To assess the tolerance of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) on the~     face.~      To assess patients' satisfaction regarding Melanoderm 4% Crema after 8 weeks.~   "
112420|NCT02095977|"~     A recent study evaluated the Manufacturer and User Facility Device Experience (MAUDE)~     database, which contains reports of adverse events involving medical devices6,9. The FDA~     updates the database every two months. A total of 107 Riata leads with reported inside-out~     insulation breaks were found, of which 105 were available for analysis. The average age of~     the leads was 62.1+/-18.6 months. A total of 226 insulation defects were found with 143~     inside-out insulation abrasions. Twenty-eight of the 105 leads (26.7%) had inside-out~     insulation defects underneath one or more of the high voltage-shocking coil. Of these, 23~     were 8F and five were 7F Riata ST leads. Exposed cables or conductors were present in 32~     leads and six leads had melted cables, presumably due to one or more high voltage shocks. 22~     of the 43 leads assessed (51.2%) also had abraded ETFE cable coating exposing the conductor.~     Noise and other sensing issues were the most common signs of failure. Seven leads were found~     to have externalized cables and five exhibited electrical abnormalities. 31 patients (29.5%)~     experienced inappropriate shocks of which 41% had abraded cables.~      A critical decision facing physicians is how to screen and manage patients who are found to~     have externalized cables. Externalized cables on fluoroscopy may precede any electrical~     abnormalities. Also noise may not be detected on all ICD models. A recent case report~     suggested that changes in lead parameters might be transient and may be missed. The lead may~     function normally as the high-voltage and pace-sense cables are covered with ETFE, which~     serves as the second insulating barrier. As this is a very thin layer (0.0015 inches) the~     reliability of this to withstand a high-energy shock is unknown. This may lead to failure of~     appropriate therapy for life threatening arrhythmias.~      The aim of this study is to screen patients with ICD leads that potentially could have~     multiple different failure mechanisms, including inside-out insulation breaks, to develop a~     novel new algorithm and methods to detect these defects, thereby enabling physicians to~     prevent complications from failure of these leads.~      It is hypothesized that current monitoring tools are insufficient for detecting the sometimes~     transient electrical failures of the Riata family of leads, and that additional device~     diagnostic information in combination with fluoroscopy may improve detection of electrical~     failures.~   "
112421|NCT02095964|"~     High density lipoprotein cholesterol (HDL-C) is in the centrum of the process of reverse~     cholesterol transport from peripheral cells to the liver[10]. HDL-C promotes endothelial~     generation of nitric oxide (NO) and improves endothelial function and arterial~     vasoreactivity[11]. In several studies, lower HDL-C level was reported to be associated with~     increased coronary artery disease (CAD) risk[12-14]. HDL-C also has anti- inflammatory and~     anti-oxidant activities[15,16]. Concerning anti-inflammatory activity, HDL-C inhibits the~     activation of monocytes/macrophages and neutrophils[17,18] and inhibits the expression of~     endothelial adhesion molecules, such as vascular cell adhesion molecule-1 (VCAM-1) and~     E-selectin[15].~      In this study we aimed to investigate the relation of HDL-C level with systemic inflammatory~     markers in patients with cardiac syndrome X (CSX).~   "
112422|NCT02095951|"~     The study team will compare hospital length of stay (LOS) and attributable length of stay~     (ALOS, the LOS attributable to CRI), in a randomized, un-blinded prospective trial utilizing~     short-dwell ethanol-lock therapy (ELT) (4 hours to 24 hour dwell times per day, repeated for~     up to 72 hours) placed within 24 hours of admission(Group 1, Preemptive ELT) versus ELT~     placed at the time of first positive blood culture report (Group 2, Rescue ELT (Standard of~     Care ). ELT will be given in both groups, in combination with systemic antibiotics, for the~     treatment of CRI (suspected or proven) of the blood in children with central catheters.~     Participants will be enrolled from patients with hematologic/oncologic disorders and bone~     marrow or hematopoetic stem cell transplants (BMT) admitted for care to Children's Hospital~     of Michigan (CHM), a tertiary care pediatric hospital in Detroit, Michigan. ALOS will be~     defined as the number of hospital days between first symptoms of Catheter-related infection~     (CRI) (or date of admission for those admitted with symptoms) and first negative blood~     culture.~      Study Hypothesis: The main hypothesis is that the short-dwell ethanol-lock therapy, defined~     above, placed within 24 hours of symptoms/admission (Arm 1) versus ELT placement at the time~     of first positive blood culture report (Arm 2), with concomitant systemic antibiotics, for~     the treatment of CRI (suspected or proven) of the blood in children with central catheters in~     the H/O/BMT population will have shorter hospital length of stay (LOS) and attributable LOS~     (ALOS) and therefore lower hospital costs.~   "
112423|NCT02095938|"~     1. Study rationale - Nielsen et al reported that after 6 weeks of amisulpride treatment,~          patients with schizophrenia showed an increase in the anticipation-related functional~          MRI signal. This suggested that amisulpride could affect the brain structures and that~          responses to amisulpride could be associated by the brain structures as seen previous~          studies about treatment response to antipsychotics and brain structures. But to date, no~          study has examined the impact of brain structure alterations on amisulpride treatment~          for schizophrenia and its potential clinical significance.~        2. Study Objectives 2-1. Primary: To show the differences of the baseline brain structures~          on the structural MRI between the Solian® treatment responders and the non-responders~          2-2. Secondary: To show the differences of the baseline polymorphisms of COMT and BDNF~          with molecular genetic analysis between the Solian® treatment responders and the~          non-responders responder defined by PANSS. To find out the correlates of baseline brain~          structures with symptom severity of schizophrenia at baseline; symptom severity defined~          by CGI-S and PANSS. To assess psychotic symptom improvement after 8th week of Solian®~          treatment using PANSS, SANS, SAPS and CGI. To assess safety after 8th week of Solian®~          treatment with Barnes Akathisia Scale, Simpson-Angus scale and vital signs. To report~          all serious adverse event within 24hrs regardless of relationship to investigational~          product.~        3. Study Design: Prospective/ Open label/ Interventional/ Controlled~        4. Evaluation Criteria:~      5-1. Primary endpoints: Brain structures on the structural MRI will be observed before the~     treatment starts. Based on the clinical response after treatment, patients will be divided in~     the two different groups as follow and their baseline brain structure of will be compared.~     Treatment responders and non-responders.~      5-2. Secondary endpoints: The relationship of baseline brain structures with symptom severity~     of schizophrenia. Severity will be determined by CGI-S and PANSS at baseline. The differences~     of the polymorphisms of COMT and BDNF with molecular genetic analysis using patients'~     peripheral blood, especially leukocytes, between the treatment responders and the~     non-responders. Efficacy - PANSS, SANS, SAPS, CGI. Safety - Barnes akathisia scale,~     Simpson-Angus scale, Vital signs~   "
112431|NCT02095834|"~     The goal of this clinical research study is to find the highest tolerable dose of carfilzomib~     when given in combination with bendamustine and dexamethasone. The safety of this drug~     combination will also be studied.~      This is an investigational study. Carfilzomib is FDA approved and commercially available for~     the treatment of certain types of MM. Its use in this study is investigational. Bendamustine~     is FDA approved and commercially available for the treatment of rituximab-refractory~     Non-Hodgkin's Lymphoma, slow-growing (indolent) lymphoma, and for chronic lymphocytic~     leukemia (CLL). Its use in this study is investigational. Dexamethasone is FDA approved and~     commercially available in combination with lenalidomide for the treatment of patients with MM~     who have received at least 1 prior therapy. Its use in combination with carfilzomib and~     bendamustine is investigational. The study doctor can explain how the study drugs are~     designed to work.~      Up to 49 participants will be enrolled in this study. All will be enrolled at MD Anderson.~   "
112432|NCT02095821|"~     Plasma exchange is a frequently used therapy in many antibody-mediated disorders, such as~     humoral rejection after kidney transplantation. Treatment frequency is adjusted to daily~     measured fibrinogen blood levels to prevent bleeding complications. However, data about the~     correlation of fibrinogen blood levels and function of the coagulation system during plasma~     exchange therapy is scarce. In the present study we examine blood fibrinogen levels and~     coagulation factors as well as thrombin clotting time in patients under plasma exchange~     therapy.~   "
112433|NCT02095808|"~     The purpose of this research study is to develop a method of using magnetic resonance imaging~     (MRI) to evaluate solitary pulmonary nodules (mass in the lung smaller than 3 centimeters). A~     pulmonary nodule is a mass or growth on the lung. An MRI is a scanning device that uses~     magnets to make images (pictures) of the body. This study is being done to determine what~     series of reactions (metabolic pathways) pulmonary nodules use as they burn sugar as fuel for~     growth. The manner in which the tumor burns (metabolizes) sugar for fuel is being~     investigated by using a natural, slightly modified, sugar solution (13C-glucose) and studying~     a small sample of the tumor once it is removed at the time of surgery.~   "
112434|NCT02095795|"~     The main objective of the present study was to compare the effects of exoskeleton devices~     used in electromechanical-assisted gait training after stroke compared to over ground~     conventional physical therapy in a single blind research.~      The second objective is to research when the devices can be used with the best chance of~     success in the functional recovery of gait in people who are unable to walk independently~     after stroke.~   "
112435|NCT02095782|"~     This is a single arm phase II clinical trial, which aims to evaluate the effectiveness of~     intercalated combination of doublet chemotherapy of paclitaxel plus carboplatin and erlotinib~     on patients with advanced stage non-small-cell lung cancer with low abundant activating EGFR~     mutation.~   "
112436|NCT02095769|"~     The goal of the POETRY Registry is to determine whether data from Pharmacogenomic (PGx)~     Testing for elderly and disabled patients can help physicians manage patient medication~     regimens and assess if the testing has an effect on reducing adverse drug events,~     hospitalizations, and emergency department visits.~      The way an individual processes or metabolizes a drug is in part determined by their genes,~     and there is known to be genetic variation from one human to another. The study of the way in~     which genes affect an individual's response to drugs is known as Pharmacogenomics.~   "
112437|NCT02095756|"~     The purpose of this study is to evaluate the efficacy and safety of a combination of~     non-hydroquinone topical therapy and a 755nm Alexandrite compared to topical therapy alone~     for the treatment of facial melasma.~   "
112438|NCT02095743|"~     Adjuvant chemotherapy is frequently proposed to patients presenting early breast cancer, in~     case of high risk of recurrence (large tumors, node involvement, high grade…). Due to its~     toxicity toward veins, chemotherapy must be administered through a central venous device.~     Today, one can use either an implanted port or a PICC line (Peripherally Inserted Central~     Catheter). A PICC line is easier to implant and to explant, but has to be flushed every week~     and may impact daily life (no swimming, some clothes may not fit). On the other hand, a port~     is subcutaneous and lets patients lead a normal life, but its implant and explant require a~     cutaneous incision with possible complications (bleeding, pain, infection). For both venous~     devices, complications such as thrombosis or infection may happen. Published data comparing~     the two devices are heterogeneous and do not often distinguish patients treated for different~     diseases at various stages. Empirically in daily practice, for long term use (>6 months) a~     port is usually preferred, whereas for short-term treatments (<6 weeks) a PICC line is used.~     In the case of Her2 negative early breast cancer, adjuvant chemotherapy usually lasts 4 to 5~     months. There is no scientific evidence for preferring one device to the other for these~     patients.~      The aim of this study is to prospectively compare the patients' satisfaction and tolerance of~     each of the two devices.~   "
112439|NCT02095730|"~     The purpose of this study is to evaluate the Safety and Efficacy of Corneal Cross Linking in~     a Continuous Beam versus Pulsed Treatments across epithelium on and epithelium off surfaces.~   "
112440|NCT02095717|"~     Multicenter randomized phase II study, double-blind, comparing Taxotere plus curcumin versus~     Taxotere plus placebo combination in first-line treatment of prostate cancer metastatic~     castration resistant. Assess time to progression (time to progression) of metastatic disease~     (from first day of treatment in the trial).~   "
112441|NCT02095704|"~     Drug dissolution in vivo play a crucial role for the bioavailability and therapeutic of an~     orally administered solid dosage form. The aim of this study was to evaluate the~     pharmacokinetics of a standard paracetamol tablet in comparison with oral solution in Chinese~     healthy volunteers. Based on the Noyes-Whitney equation and pharmacokinetics parameters,~     investigators trend to propose a method to estimate in vivo dissolution time and dissolution~     kinetics of solid dosage form.~   "
112442|NCT02095691|"~     This is a prospective, multi-center, non-randomized, feasibility study to assess the safety~     and effectiveness of renal artery sympathetic denervation using the investigational devices~     in subjects with resistant hypertension.~   "
112756|NCT02091557|"~     To assess the diagnostic accuracy for the noninvasive detection of pelvic endometriosis of~     the combination of two simple parameters: modifications of serum CA 125 and VAS pain score~     following one dose of GnRH-analog (GnRH-a).~   "
128406|NCT01886664|"~     The investigators tried to evaluate the effect of desflurane on the incidence of~     postreperfusion syndrome during living donor liver transplantation surgery. The investigators~     used sevoflurane as a comparison.~   "
112443|NCT02095678|"~     The primary objective of this study is to develop and validate simultaneous free-breathing 4D~     fat and water quantification and quantitative dynamic contrast enhanced perfusion in the~     liver. Secondary aims include developing and validating free breathing quantification of~     relaxation parameters T1 and T2, and developing and validating a minimal breath-hold (< 8 s)~     high quality diffusion exam using highly accelerated steady state diffusion imaging~     sequences. Investigators aim to scan 100 subjects receiving liver biopsies as a part of their~     standard care and another 70 subjects with known benign lesions. The study is greater than~     minimal risk.~   "
112444|NCT02095665|"~     Ureteric stents are used often following ureteroscopy for prevention of obstruction from~     edema and or stone fragments. They are often associated with pain, voiding often, the need to~     urinate quickly and finding blood in the urine called lower urinary tract symptoms or LUTS~     for short. There is randomized studies showing the efficacy of α-blockers such as tamsulosin~     in relieving stent symptoms (pain and LUTS). There is emerging but limited evidence to show~     that antimuscarinic medications, used to treat overactive bladder (OAB) have some efficacy in~     decreasing stent symptoms. Mirabegron is a beta-agonist used to decrease OAB symptoms.~      Mirabegron functions to mediate relaxation of the detrusor muscle and has been useful in~     treating OAB symptoms. Conventional antimuscarinic medications often have bothersome side~     effects like dry mouth, constipation, blurred vision and cognitive impairment. This may limit~     their use in some populations. Mirabegron is well-tolerated with a good safety profile and~     therefore may be useful in treating stent symptoms without the bothersome side effects~     commonly seen with antimuscarinic medications. .~      The investigators hypothesize that mirabegron is effective in decreasing ureteral stent~     related LUTS and pain.~   "
112445|NCT02095639|"~     The purpose of this study is to explore whether electroconvulsive therapy (ECT) accidentally~     leads to a side effect of brain inflammation. Patients with treatment resistant depression~     who are planning to take ECT will be subsequently approached to participate in the study.~   "
112446|NCT02095626|"~     The purpose of this study is to investigate the effect of orally inhaled AP-301 on primary~     graft dysfunction after lung transplantation.~   "
112447|NCT02095613|"~     The study hypothesizes that one form of food supplement to HIV-infected individuals in Haiti~     (ready-to-use-supplementary food) will result in improved HIV, nutrition and quality of life~     outcomes when compared to a second type of food supplement (corn-soy-blend) over the course~     of 12 months of food supplementation.~   "
112448|NCT02095600|"~     Stereotactic lesioning of thalamus and basal ganglia for treatment of tremor is a well-known~     procedure which, prior to the introduction of deep brain stimulation, or DBS, was usually~     achieved using stereotactic surgical procedures.~      Radiosurgery of invisible targets to treat movement disorders and intractable pain are still~     the domain of frame-based procedures, due to the need of a solid reference system registered~     to the anterior commissure-posterior commissure (AC-PC) line, which allows the use of~     stereotactic atlases.~      In this study we want to utilize a mathematical method that uses atlas-derived stereotactic~     coordinates to perform frameless images-guided radiosurgery of such functional targets~     Particularly the aim of the present study is to investigate both the efficacy and the safety~     of the methodology to treat upper limb and hand tremor in elderly or in patients which are~     not ot susceptible of surgical procedures. For these reasons a dose escalation prospective~     trial have been designed.~   "
112449|NCT02095587|"~     To evaluate the pharmacokinetics, safety, and tolerability of IPI-145 when administered to~     subjects with chronic hepatic impairment and in matched healthy subjects.~   "
112450|NCT02095574|"~     A pharmacokinetic study to access how the body absorbs and removes ABT-199 in adults with~     Non-Hodgkin's Lymphoma.~   "
112451|NCT02095561|"~     Cervical cancer is a leading cause of mortality among women in developing countries. A key~     factor has been the failure to achieve good coverage. The development in the last years of~     HPV-DNA based tests has changed the scenario, because it combines a high performance to~     detect disease with a reduction of screening frequency. Through self-testing, HPV testing has~     the potential of reducing social and health service barriers faced by women to access~     screening.~      This study is carried out in Jujuy, one of the Argentinian provinces with highest cervical~     cancer mortality rates and where HPV testing has been introduced as a primary screening test~     for all women attending public health sector. The study was conducted between July~     2012-December 2013, and supported by the Argentinean National Cancer Institute. The protocol~     was approved by the institutional review committees of the Ministry of Health of Jujuy.~      This trial is a randomized by population clusters study that aims to assess the effectiveness~     of self-testing to increase coverage. The aims of this study are: a) to assess the self-test~     effectiveness to increase the participation of women in screening programs, b) to assess the~     self-test acceptability by women, c) to assess HPV self-test effectiveness measurement for~     the detection of CIN2+ lesions against cytology in primary screening.~      An overall number of 200 community health workers (CHWs) from the Primary Health Care System~     (PHCS) of Jujuy will be randomized into two groups that will be named Self-test Group (ST)~     and Conventional Sample Group (CS):~        1. ST Group: CHWs will invite eligible women of their area to choose between doing a~          self-test or having a conventional sample taken by a health professional of the closest~          health care center.~        2. CS Group: CHWs will invite eligible women in their area to have a conventional sample~          taken by a health care professional of the nearest health care center.~      In order to measure the self-test relative sensitivity against cytology to detect CIN2+ in~     primary screening, all the women in the Self-test Group who have decided to do the self-test~     and all the women of 30 years of age and older that were screened with cytology by the~     provincial program for the prevention of cervical cancer in 2011 will be considered.~      A database built specifically for the study will be used; it will hold the list of eligible~     women to participate in the study. The records of women of 30 years of age and older residing~     in the areas included in the study will be imported from the PHCS databases.~      In addition, the data surveyed by the study will be uploaded: randomization Group, presence~     of the woman at home during the CHW's visit, agreement to participate in the study,~     realization of self-test (in the corresponding group), and if appropriate, reasons for not~     doing the self-test. Lastly, the HPV Test realization will be uploaded importing the data on~     SITAM, (link of data done as from the identity card number).~      Data Analysis~      Self-test acceptability: Acceptability is defined as the number of women accepting the~     self-test against the number of women offered the option between the self-test and the~     conventional sample (proportion of women accepting the self-test). The acceptability in this~     population will be estimated as the average of acceptabilities calculated by CHW, as to~     control the impact of the CHWs on acceptability and reach an appropriate variance estimate.~     Besides, the variability introduced by the CHWs on acceptability will be studied and the~     results obtained by male and female CHWs will be compared, as well as those obtained by the~     CHWs in rural and urban areas.~      Self-test effectiveness to enhance participation of women in screening and diagnosis: There~     will be a comparison of the percentage of women that did the HPV test in the Self-test group~     and the Conventional sample group. Three different coverage indicators will be considered for~     every CHW. These will be defined as the number of women screened within the field work~     regarding:~        1. The number of women reached by the CHW who accepted participating in the study.~        2. The number of eligible women for that CHW (regardless of whether the CHW was able to~          contact them or not).~      The effect of the strategy (offering the self-test option against promotion of the~     conventional sample) will be estimated for each one of the coverage measures using a means~     difference test or a non-parametric test for independent samples.~      CIN 2+ detection rate: The effectiveness of the HPV Self-test against screening cytology to~     detect CIN2+ will be estimated as the detection rates difference and as the detection rates~     ratio. In addition, there will be a comparison of the CIN2+ detection rate in the group of~     women who did the self-test against the total number of women in the province of Jujuy that~     were tested for HPV (conventional sample strategy + triage Pap test) until December 2012.~   "
112452|NCT02095548|"~     The purpose of this study is to find the optimal dose of SM04690 that can be safely given by~     intra-articular injection into the target knee joint of subjects with moderate to severe~     osteoarthritis.~   "
112453|NCT02095535|"~     Before a patient gets a spinal/epidural, their lower back is cleaned with an antiseptic~     solution diluted in alcohol called ChloraPrep. ChloraPrep must completely dry before starting~     the anesthetic procedure. It is not known how much time is needed for the solution to~     completely dry. The investigators aim to determine this.~      As the ChloraPrep dries, the alcohol is converted into vapour. The investigators will be~     using a PPBRae 3000 device to detect small amounts of vapours in the air. As the ChloraPrep~     dries it gives off less and less vapour. The investigators will use this diminishing vapour~     concentration to determine when drying is complete.~   "
112454|NCT02095522|"~     Colchicine has antiinflammatory properties. It has been shown to be effective in improving~     outcome in stable coronary disease. The exact mechanism is unclear. Study objective: to~     assess the effect of colchicine on endothelial function using the EndoPAT™ in NSTEMI~     Patients.~      Study Hypothesis: There will be a significant difference on the RH-PAT levels of the patients~     who were in treated with colchicine versus the placebo group Study design and patient~     Selection One hundred and forty patients with the diagnosis of Non ST Elevation Myocardial~     Infarction will be enrolled to a prospective randomized double-blind placebo controlled study~     in Tel Aviv Medical Center, Tel Aviv, Israel. Patients will be recruited during their~     hospitalization before cardiac catheterization. All patients will sign an informed consent.~      Primary outcome will be the improvement in endothelial function between baseline and after 1~     month in both groups~   "
112455|NCT02095509|"~     To evaluate the pharmacokinetics of the thromboprophylactic agent enoxaparin in critically~     ill patients by comparing plasma anti-factor Xa activity when enoxaparin is administered~     either as a continuous intravenous infusion or subcutaneous bolus once daily.~      To investigate possible ongoing coagulation by coagulation markers during antithrombotic~     therapy with standard doses of enoxaparin~   "
112456|NCT02095496|"~     Sleep's deficiencies are very common in intensive care. Mechanical ventilation is a known~     factor in this deterioration.The investigators hypothesize that close-loop ventilation mode~     (Intellivent-ASV) is able to minimize sleep deterioration, adjusting ventilation to the~     patient needs.~   "
112457|NCT02095470|"~     new glidoscope was tested on 401 patients~   "
114041|NCT02074748|"~     This study is an observational change from baseline outcome measures design. Data is~     collected for the sake of evaluating treatment (fusion surgery) performed as standard medical~     care, but the investigator does not assign specific interventions to any participants in this~     study.~   "
112458|NCT02095457|"~     Scientific Background: Inherent gaps exist between the worlds of research and clinical~     therapy, especially in mental-health systems. Developed as an important strategy aimed to~     bridge them, widening efforts worldwide have implemented Routine Outcome Monitoring (ROM), a~     method devised for systematic ongoing quantitative measurements used in diverse clinical~     practices, from psychotherapies to psychiatric management. The efficacy of this approach has~     been repeatedly demonstrated in various measures, such as satisfaction with treatment by~     patients and therapists, lower drop-out rates, symptomatic benefits, and more.~      Objectives: The aim of the current study is to test the feasibility and the clinical benefits~     of implementation of a Routine Outcome Monitoring System in a public clinical center, as a~     pioneering project in Israel, at the Shalvata Mental Health Center.~      Working Hypotheses: Incorporation of a ROM system in routine clinical practice is~     hypothesized to improve patients' and therapists' overall satisfaction, allow for early~     detection and intervention in therapeutic raptures, decrease drop-out rates, and improve~     various clinical outcome measures.~      Methods: The suggested study is a two-stage (implementation and intervention) open trial. 900~     new outpatients in 'Shalvata' clinics will be recruited and randomized to intervention (ROM)~     and control groups. Assessment questionnaires will be filled periodically using 'CORE-NET', a~     computerized system enabling repeated measurements and feedback in a user-friendly and~     efficient manner.~      Data Analysis: The evaluation of the differential influence of monitoring processes on~     overall efficiency as compared to control group will be tested using Multiple Analysis of~     Variance (MANOVA). The predictive value of possible variables on process and outcome of~     therapy will be assessed using stratified regression analyses. The possible causal effects~     between specific lagged variables will be assessed using Hierarchical Linear Modeling and~     Time Series Analysis.~      Contribution: This pioneering study is the first in Israel to offer a routine systematic~     evaluation of therapeutic processes, as well as assessing its clinical effects. Consequently,~     a large and meaningful data-set will emerge, enabling significant enrichment of our~     evidence-based understanding of therapeutic processes.~   "
112459|NCT02095444|"~     The purpose of this study is to determine whether human menstrual blood-derived stem cells~     are effective in the treatment of infection of H7N9 virus caused acute lung injury.~   "
112460|NCT02095431|"~     Acute kidney injury (AKI), is a common complication of patients undergoing liver~     transplantation. Timing and definition of AKI, usually based on serum creatinine, have been~     inaccurate and inconsistent.~      We hypothesized that the pattern of novel biomakers elevation could be a prognostic tool to~     provide information on the risk of progression of AKI, the need for RRT and mortality.~   "
112461|NCT02095418|"~     With improvements in patient and graft survival, increasing attention has been placed on~     complications that contribute to long-term patient morbidity and mortality. New-onset~     diabetes after transplantation (NODAT) is a common complication of solid-organ~     transplantation, and is a strong predictor of graft failure and cardiovascular mortality in~     the transplant population. Risk factors for NODAT in transplant recipients are similar to~     those in non-transplant patients, but transplant-specific risk factors such as hepatitis C~     (HCV) infection, corticosteroids and calcineurin inhibitors play a dominant role in NODAT~     pathogenesis. The predominant factor for causing NODAT by corticosteroids seems to be the~     aggravation of insulin resistance; however several studies have displayed deleterious effects~     on insulin secretion and β-cells. Thus, adjusting the immunosuppressant regimen to improve~     glucose tolerance must be measured and defined from long term perspective.~      As recipients of organ transplants survive longer, the complications of NODAT have assumed~     greater importance; therefore, we designed a prospective study to compare the safety and~     efficacy of early versus late withdrawal of corticosteroids after liver transplantation.~   "
112462|NCT02095405|"~     Stimulants and drugs are often associated with cardiac effects. Caffeine, a therapeutic~     xanthine, has been described as a sympathomimetic and has shown to have stimulatory effects~     on the heart. Patients with symptomatic cardiac arrhythmias are generally informed by their~     physician to stop or significantly reduce caffeine intake. However, in spite of numerous~     reports that have reviewed the cardiac effects of caffeine, it remains unclear to what extent~     this stimulant may be detrimental, and what subgroups of patients may be most vulnerable. The~     investigators propose to evaluate the effects of caffeine in patients with previously~     diagnosed cardiac arrhythmias. The results of our report will provide important new~     information for physicians and patients regarding the effects of caffeine on symptomatic~     cardiac arrhythmias.~   "
112463|NCT02095392|"~     The study was conducted to investigate the effect of soluble phosphate in combination with~     different calcium doses on calcium and phosphorus metabolism and further physiological~     parameters in healthy subjects. The main aim of the study is to investigate the influence of~     a soluble phosphate supplementation on the fasting blood phosphate concentration and the~     dependency of an additional calcium intake.~   "
112464|NCT02095379|"~     In this study, the investigators aim to investigate the prevalence and clinical course of~     oligosecretary myeloma.~   "
112465|NCT02095366|"~     Intranasal (IN) administration of opiates is an appealing non-invasive way of treating acute~     traumatic pain in prehospital and Emergency departments (ED).~      The investigators hypothesize that IN administration of Sufentanil is equal as compared with~     Intra veinous (IV) administration of Morphine wich is widely recommended in ED.~      The investigators study is a multicentric, comparative, randomized, double-blind,~     double-placebo study, comparing quality of analgesia in both groups 30 minutes after first~     administration of opiates.~      The investigators also asses side effects and patient satisfaction in both groups.~   "
112466|NCT02095353|"~     The investigators propose to analyze the perfusion (blood flow) characteristics of blood~     tumors. The investigators will be comparing the use of two contrast agents in this study.~   "
112467|NCT02095340|"~     The purpose of this study is to expand our understanding of the intergenerational~     transmission of cognitive risk for childhood anxiety disorders by examining whether changes~     in maternal interpretations of situations result in changes in child interpretations and~     child anxiety.~   "
112468|NCT02095327|"~     The purpose of our study is to better understand how caregivers of individuals with dementia~     cope with their family member's illness. If you are eligible for the study and would like to~     participate, we will schedule a one-time phone interview, which will last approximately 2~     hours for which you will be compensated for your time.~   "
112469|NCT02095314|"~     Measure antibody persistence prior to booster administration of Pentabio vaccine.~   "
112470|NCT02095301|"~     The objective of this study is to assess the effects of an herbal extract on mental energy in~     healthy human subjects.~   "
112529|NCT02094534|"~     This will be a prospective, randomized, double-blind, placebo controlled study. Patients with~     established Type 1 diabetes will be eligible for entry into the study. Eligible patients will~     be screened and those who fulfill all inclusion/exclusion criteria will be admitted to the~     inpatient unit no fewer than 2 days and no more than 7 days after Screening. Patients will~     report to the inpatient unit at 6 a.m. and outfitted with a continuous glucose monitoring~     (CGM) device. Patients will be given standardized meals and snacks for the duration of their~     inpatient visit.~   "
112471|NCT02095288|"~     Cardiovascular complications of NSAIDs, selective for inhibition of COX-2, stimulated~     interest in microsomal prostaglandin E synthase-1 (mPGES-1) as an alternative drug target.~     Global deletion of mPGES-1 in mice suppresses PGE2 and augments PGI2 by PGH2 substrate~     rediversion. Unlike COX-2 inhibition or gene deletion, mPGES-1 deletion does not cause a~     predisposition to thrombogenesis and hypertension. However, cell-specific deletion of mPGES-1~     reveals that the predominant substrate rediversion product amongst the prostaglandins varies~     by cell type, complicating drug development. We have developed an ultra performance liquid~     chromatography/ tandem mass spectrometry (UPLC-MS/MS) technique that allows the~     quantification of a wide range of lipids beyond the prostaglandin pathway (leukotrienes,~     anandamide and the 2-arachidonylglycerol cascades).~      This study is designed to examine different pathway interventions from the arachidonic acid~     cascade by anti-inflammatory compounds (with a focus on mPGES-1 inhibition) in whole human~     blood in vitro (Part A) and ex vivo (Part B). In Part A, whole human blood will be donated by~     healthy volunteers and treated with screening compounds in vitro (outside of the body).~     Experiments will be performed to measure an array of lipids in plasma and serum from~     pre-stimulated whole blood treated with a single or a combination of the test compounds.~      This study may reveal pathways previously unknown to be affected by the existing~     anti-inflammatory drugs and drug candidates, and will possibly suggest new indications and/or~     side effects.~   "
112472|NCT02095275|"~     B-type natriuretic peptide (BNP) is rapidly released by the ventricles of the heart in~     response to myocardial stretch. This cardiac neurohormone is mostly elevated in patients with~     fluid overload or myocardium dysfunction. BNP is a very useful and important marker. It can~     predict mortality and cardiac events in patients in the ICU setting. In stable hemodialysis~     patients with normal LV function on echocardiography, high BNP levels are likely the result~     of blood volume expansion and require reduction in postdialysis dry weight.~      In the past, there were many methods to evaluate fluid status. Some are not reliable such as~     central venous pressure or physical examination. Some are invasive and expensive such as Swan~     Ganz、PiCCO catheter or bioimpedance device. Nevertheless, About the relationship between BNP~     and fluid status, a study found a significant relation between bioimpedance-derived body~     composition (BC) (fluid distribution) parameters and BNP concentrations. This relationship~     was independent of the cardiac history of the patient and suggests that the natriuretic~     peptide levels are to some degree modifiable by changing a patient's fluid distribution.~      In this study, the investigators want to observe that if the level of BNP can predict the~     occurrence of acute kidney injury and the need of renal replacement therapy. Besides, the~     investigators also want to see if BNP can be a useful and convenient marker to guide~     adjustment of optimal fluid status and then to improve outcome.~   "
112473|NCT02095262|"~     Tinnitus refers to a the perception of a ringing, hissing or buzzing sound despite there~     being no such sound in the external world. It is prevalent and for many individual is a~     distressing condition. Recent advances in the understanding of changes in the hearing brain~     and their relation to tinnitus perception has led to a focus on forms of active auditory~     training which might provide effective techniques for tinnitus management. Our recent trial~     of auditory training provided evidence that training using sounds where there is no hearing~     loss has benefit in terms of reduced tinnitus intrusiveness, above training at where there is~     some level of hearing loss. Our next challenge is to build on this finding in ways that might~     maximize the benefits we observe.~      The training software we used previously was developed for use with children. Past~     participants have given mixed reviews of this software. While some enjoyed the training or~     found it soporific, others reported that they found it too monotonous and un-motivating. We~     therefore wish to explore the impact of different game mechanics in the delivery of auditory~     training and have designed two different interactive games in the context of training for~     tinnitus benefit. These games will deliver the same type of auditory training as the software~     we currently use, but should be intrinsically motivating, i.e. be a game that the people are~     motivated to play irrespective of any potential benefit for tinnitus. The game we previously~     used is reactive, i.e. the sounds play and the player selects what they think is the correct~     answer (odd one out).~      The two new games we wish to test can be described as interactive, i.e. players control the~     sound delivery and actively seek the correct answer: this may have additional benefit for~     tinnitus.~   "
112474|NCT02095249|"~     Prostate cancer is the most commonly diagnosed form of cancer in Canadian men. In 2006,~     greater than 250,000 men were diagnosed with prostate cancer in the United States and Canada~     with more than 32,000 men dying of their disease. Using the prognostic variables of~     T-category, the serum prostate specific antigen (PSA), and the pathologic Gleason score (GS),~     men with localized prostate cancer are placed in low, intermediate and high-risk groupings.~     Usually this is treated with surgery, radiation therapy, hormone therapy and/or watchful~     waiting (also known as active surveillance). While these treatments are quite effective,~     tumours are likely to recur in about 40% of cases. There is a need for additional prostate~     cancer treatments. To address this need, many experimental therapies are being developed and~     tested in mice with prostate tumors. This includes the study of aggressive prostate cancer~     cells such as stem cells, or Tumour Initiating Cells (TICs), or oxygen deprived cells, which~     may be the ones most likely to re-grow into a tumour or spread throughout the body.~     Researchers want to try and isolate these special cells from the prostate after surgery to~     study their features, and to see if they can re-grow as solid tumours in mice. Researchers~     would like to test whether the prostate cancer stem cells are more resistant or less~     resistant to treatments. This will allow researchers to study and test new treatments that~     specifically target resistant and aggressive prostate cancer cells. The investigators~     hypothesize that marker-defined TIC cells or hypoxic cancer cells have unique genetics in~     primary prostate cancers and are relatively chemo- and radio-resistant.~   "
112475|NCT02095236|"~     Radioopaque fiducial markers or electro-magnetic transponders will be implanted into or in~     close proximity of the tumor. During a radiotherapy treatment session image and/or signal~     acquisition will be performed by ultrasound, computed tomography, magnetic resonance imaging~     or by specialized signal detectors The data will help to characterize tumor and organ motion~     during one treatment session which may in fact have impact on dose distribution~   "
112530|NCT02094521|"~     This trial is conducted in Europe. The aim of the trial is to evaluate the optimal dosing~     conditions for GLP-1 analogue NNC0113-0987 when administered orally in healthy male subjects.~   "
112476|NCT02095223|"~     Muscle inhibition prevents optimal contraction of the quadriceps muscle due to changes in the~     nervous system after knee joint injury. Current treatments for muscle inhibition at this time~     include knee joint cryotherapy and electric stimulation prior to exercise. These treatments,~     in addition to strengthening exercises, have shown improvements in the quality and strength~     of muscle contractions however, they have a short window of effectiveness. Electromyographic~     Biofeedback is proven to be useful in improving quadriceps strength but the mechanism of~     action remains somewhat unclear. Therefore, the purpose of this investigation is to compare~     the effectiveness of electromyographic biofeedback supplemented exercise when compared to~     traditional exercise on quadriceps muscle function in individuals with a history of knee~     injury and current evidence of quadriceps inhibition. We hypothesize that 14 days of~     electromyographic biofeedback supplemented exercise will lead to larger gains in quadriceps~     activation when compared to traditional exercise.~      Thirty 18-40 year old participants with a history of knee injury and current evidence of~     quadriceps muscle inhibition will be enrolled in this single blind randomized controlled~     trial. Participants will provide written consent prior to all study procedures. Following~     enrollment, participants will be asked complete questionnaires related to knee related~     function, current levels of pain, and current activity level followed by completion of~     baseline measurements.~        1. We will use the superimposed burst technique to quadriceps muscle activation.~        2. We will measure the Hoffmann reflex response of the quadriceps with surface~          electromyography. We will measure this signal with surface electromyography electrodes~          that record the activity of the quadriceps muscle through the skin.~      Participants in both groups will be instructed on a 14 day home exercise protocol on the day~     of enrollment. The protocol is comprised of 4 exercises focused on both non-weight bearing~     and weight bearing quadriceps strengthening. Compliance will be monitored via a daily~     exercise diary which will be collected at the end of the study protocol.~      Quadriceps central activation ratio, active motor threshold and Hoffmann reflex will be~     reported descriptively. Pre-intervention and post 14 day intervention quadriceps central~     activation ratio and Hoffmann reflex will be compared between traditional exercise and~     Biofeedback supplemented exercise~   "
112477|NCT02095210|"~     This is an open-labeled, exploratory, single center study. Patients with a big primary breast~     cancer (≥ 3 cm) or metastatic first line, routinely have their HER2-expression determined by~     biopsy. Patients having a HER2-positive tumor will be recruited to the study. A [18F]FDG~     PET/ceCT scan is performed for the measurement of uptake in the tumour and diagnosis of~     possible metastases. Each subject will receive a single injection of the investigational~     product [68Ga]ABY-025, followed by measurement of uptake in the tumour or metastases and in~     normal organs. The investigations will be repeated after HER2 directed therapy.~   "
112478|NCT02095197|"~     Cervical radicular pain is a common, disabling problem, occurs in 83:100,000 individuals per~     year. Symptoms are most often caused by intervertebral disc herniation (21.9%) or central or~     foraminal stenosis from spondylosis (68.4%). Patients complain of pain in the head, neck,~     scapula or arm. The diagnosis of radicular pain is made clinically by history and physical~     examination, supported by imaging studies and electrodiagnostic tests. No study has compared~     the differences in pain, medication utilization, functional outcomes, or patient satisfaction~     between interlaminar and targeted epidural injections in the cervical spine. In theory, the~     technique of targeted epidural steroid delivery with a catheter has a lower risk of~     accidental vascular trespass or disc penetration during the procedure, and far less risk of~     dural penetration or spinal cord injury at rostral levels of the cervical spinal cord as~     compared with the interlaminar technique. The investigators hypothesize that this technique~     results in superior pain control, decreased medication use, improved function and fewer~     repeat injections. This data could improve patient safety and affect the evolving treatment~     guidelines for cervical epidural injections.~   "
112479|NCT02095184|"~     More than three quarter of patients with breast cancer are treated by hormone pills called~     tamoxifen and aromatase inhibitors (AIs). AIs are drugs that stop female hormone production.~     This hormone production mostly happens in fat, muscle, and breast tissue in postmenopausal~     women. The female hormone estrogen is an important hormone for the growth of breast cancer~     cells. Anastrozole (Arimidex®) and Letrozole (Femara®) are AIs that are approved by the Food~     and Drug Administration (FDA). They have been used since 2005 to treat women with early stage~     breast cancer.~      When given before surgery (neoadjuvant), both anastrozole and letrozole have been shown to~     successfully shrink breast cancer tumors in most patients. In over 50% of patients,~     anastrozole and letrozole when given for about 4 months also helped to improve surgery~     outcomes. On top of that, whether or not a patient responds to anastrozole and letrozole~     before surgery can help the doctor decide whether that patient needs additional chemotherapy.~      One of the things may influence the level of hormone is body weight. It has been previously~     shown that postmenopausal women with higher body fat have higher level of female hormone as~     well as an increased risk of breast cancer. This is likely due to an increase in aromatase~     activity in the fatty tissue. However, at the current time AIs are used at the same doses in~     all women with breast cancer no matter whether they have different body weight. Currently, we~     do not know for certain whether the same doses of AIs work as well in patients with higher~     body fat compared to patients with less body fat.~      The purpose of this study is to see if women with higher body fat respond differently to AI~     treatment compared to women with lower body fat.~   "
112480|NCT02095171|"~     This single ascending dose study is to determine safety, tolerability, pharmacokinetics and~     immunogenicity of PRX002 in approximately 40 healthy subjects.~   "
112481|NCT02095158|"~     This study will evaluate the long-term safety and efficacy of oxymetazoline hydrogen chloride~     (HCL) Cream 1.0% (AGN-199201) in patients with persistent erythema associated with rosacea.~   "
112482|NCT02095145|"~     This randomized phase II trial studies pomegranate-extract pill in preventing tumor growth in~     patients with prostate cancer that is limited to a certain part of the body (localized), who~     have chosen observation as their treatment plan. The use of pomegranate-extract pill may slow~     disease progression in patients with localized prostate cancer.~   "
112483|NCT02095132|"~     This phase I/II trial studies the side effects and best dose of WEE1 inhibitor MK-1775 and~     irinotecan hydrochloride in treating younger patients with solid tumors that have come back~     or that have not responded to standard therapy. WEE1 inhibitor MK-1775 and irinotecan~     hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth.~   "
112484|NCT02095119|"~     The following is an open label, non comparative, pilot study of palliative treatment as a~     second, third line or more of treatment in patients with recurrent, persistent or Metastatic~     Cervical Cancer; it has a limited sample of 15 patients with the primary goal of evaluating~     the response (defined as: Complete, partial or stable disease) to treatment with a Monoclonal~     Antibody, Nimotuzumab, on a weekly basis + CDDP 50mg/m2/BSA as a single agent every 3 weeks~     for patients with good renal function (Creatinine clearance => 60) or Gemcitabine 800~     mg/m2/BSA in patients with renal failure (Creatinine clearance <60).~      Secondary objectives consist of evaluating disease-free survival, overall survival and assess~     patient tolerance to treatment with Nimotuzumab.~   "
112541|NCT02094378|"~     The purpose of this study is to assess the cognitive effects associated with administration~     of intranasal esketamine 84 mg.~   "
112485|NCT02095106|"~     Distal radius fractures are one of the most commonly seen fractures in children.~     Traditionally, minimally angulated or non-displaced distal radius fractures are treated with~     short or long-arm cast immobilization for up to 8 weeks. The traditional fiberglass casts~     used must be kept dry to prevent inflammation and potential infection. If a fiberglass cast~     gets wet, it must be removed and replaced. In general, waterproof casting has been shown to~     improve patient comfort and overall satisfaction.~      We intend to explore the efficacy of a new, waterproof cast made of a hybrid mesh in the~     treatment of minimally angulated distal radius fractures in children using a randomized,~     controlled, cross-over study design. We will include patients between 4 and 14 years of age~     with minimally angulated distal radius fractures (<15 degrees of angulation on sagittal or~     coronal planes) presented to the Orthopaedic Institute for Children Urgent Care Facility~     within 7 days of injury. As determined by a power analysis, a total of 26 patients will be~     enrolled in the study.~      Patients eligible for the study will be randomized into one of two equally sized (n=13)~     groups: patients in Group 1 will receive a short arm cast made of the waterproof hybrid mesh~     material and patients in Group 2 will receive a regular fiberglass cast. Both groups will~     follow-up at two weeks for clinical and radiological evaluation, after which they will be~     transitioned into a regular fiberglass cast (Group 1) or a hybrid mesh waterproof cast (Group~     2) for an additional two weeks. This crossover will allow both groups to experience each type~     of cast. After four weeks of immobilization, patients in both groups will discontinue casting~     and be advised to avoid contact sports or strenuous activities until week 8.~      Patients in both groups will follow up 8 weeks after initial treatment for clinical and~     radiological evaluation to evaluate range of motion, pain, and fracture alignment. Physical~     function will be evaluated at weeks 1, 2, and 4 using the Activities Scale for Kids -~     Performance, a validated, highly reliable, self-reported measure that assesses physical~     function in children between 5 and 15 years. Pain will be evaluated using the Faces Pain~     Scale, a validated, highly reliable scale commonly used in the pediatric population. Patient~     satisfaction will be measured at Weeks 1, 2, and 4, and the radiographs at Week 8 will be~     compared with initial radiographs to assess fracture displacement and angulation. Skin~     changes will be assessed at week 2 and week 4 by an independent observer blinded to the type~     of cast that has been removed and digital photographs will be obtained and analyzed using~     ImageJ Image Processing and Analysis Software to calculate the surface area of any described~     skin changes as a percentage of total skin area originally covered by the cast. Itching will~     be assessed at weeks 1, 2, and 4 using a visual analogue scale in which a horizontal line of~     100 mm will be presented to the patient with no itching at the left end of the scale and~     strongest itching at the right end.~      We hope to determine whether the new, waterproof cast can result in similar clinical outcomes~     and patient satisfaction for distal radius fractures as compared with the traditional~     fiberglass cast.~   "
112486|NCT02095093|"~     Leg length discrepancies following total hip arthroplasty have been associated with nerve~     palsies, gait abnormalities, and lower back pain. Leg length discrepancies are related to~     poorer functional outcomes and patient dissatisfaction. Failure to restore femoral offset~     following total hip arthroplasty has been linked to decreased range of motion and abductor~     muscle strength, impingement, limping, higher dislocation rates, increased polyethylene wear,~     and loosening of implants. Computer navigation has shown to improve the accuracy of leg~     length and hip offset during total hip arthroplasty. The investigators research objective is~     to prove the accuracy of the Intellijoint HIP™ system for determining leg length and hip~     offset. The investigators hypothesis was that Intellijoint HIP™, an imageless intraoperative~     intelligent instrument, could improve the accuracy of leg length and hip offset during~     primary total hip arthroplasty. The investigators plan to study this hypothesis in humans by~     comparing the leg length and hip offset discrepancies produced with Intellijoint HIP™ to the~     standard at the investigators institution, which is a pin and outrigger system.~   "
112487|NCT02095080|"~     Amino acid are the building blocks of the body's protein. Some amino acids, including~     leucine, cannot be made in the body and must be obtained from diet, these are called~     essential. With increase in age the body's muscle mass decrease and studies have suggested~     that dietary supplementation of leucine may have potential health benefits in elderly in~     regards to prevention of age related loss of lean muscle mass, and thus may help improve the~     quality of life in elderly.~      Currently, a safe upper dietary intake level of leucine has not been established for healthy~     elderly. Prior to exploring whether leucine supplementation will prevent or decrease loss of~     lean muscle mass in elderly we propose to identify the upper intake of leucine in healthy~     elderly.~      The purpose of this study is to determine the tolerable upper intake level (UL) of leucine in~     healthy elderly men (70 - 75 yrs)~      The investigators hypothesize that with a careful graded stepwise increase in leucine intake~     in elderly men, above the Estimated Average Requirement (EAR - 50 mg/kg/d), the body's~     ability to oxidize/dispose of excess amino acids will reach a maximum. With increased leucine~     intakes we hypothesize an increase in plasma ammonia concentrations and increases in plasma~     leucine and urinary leucine excretion.~   "
112488|NCT02095067|"~     The prehospital resources are limited. The emergency medical dispatch center (EMDC) is manned~     by qualified health care personnel around the clock. The investigators believe that the EMDC~     is an unexploited resource in the prehospital treatment of patients. By the use of~     videoconferencing the investigators will activate this resource.~      Mobile videoconferencing between ambulances and physician at the EMDC enables patient~     consultation at a distance. Video consultation between patient and the physician at the EMDC~     can take place when the patient is at home or in the ambulance.~      The primary aim of this study is to examine the effect of video consultation between~     physicians at the EMDC and patients receiving treatment by ambulance personnel on the number~     of patients receiving final treatment on-site in the pre hospital setting.~   "
112489|NCT02095054|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of regorafenib and cetuximab that can be given to patients with advanced solid~     tumors. The safety and effectiveness of this drug combination will also be studied.~   "
112490|NCT02095041|"~     Oxygen is carried in the blood attached to hemoglobin molecules. Oxygen saturation is a~     measure of how much oxygen hemoglobin is carrying as a percentage of the maximum it could~     carry. Oxygen saturation can be measured non-invasively using pulse oximetry. On occasion,~     term infants are admitted to the intensive care nursery for monitoring and show variability~     in their oxygen saturation despite appearing well. As healthy newborns do not undergo routine~     monitoring of oxygen saturation, health care team do not know the degree to which variability~     in oxygen saturation are a normal phenomenon. With increasing interest in using pulse~     oximetry as a screening tool to identify at risk newborns, it is important to have a clear~     understanding of postnatal oxygen saturation trends and their variability in healthy babies.~      In our study, Investigators will measure oxygen saturation on healthy newborns repeatedly and~     for extended periods. This will allow us to describe both the variability in oxygen~     saturations and the pattern of changes observed in oxygen saturations over time in healthy~     newborns. To increase our confidence that babies included in our study were healthy at birth,~     they will be followed for 8 weeks to identify indicators of perinatal disease that was missed~     clinically. Any babies subsequently identified as having significant disease will be analyzed~     separately from the main cohort of healthy babies. Furthermore, the oxygen saturation~     readings will be obscured so as not to influence caregivers inappropriately. Lastly, pulse~     oximetry measurements will be performed after discharge from hospital (on day 3 to 4),~     potentially increasing the clinical utility of this study as it has repeatedly been stated in~     the literature that the sensitivity of pulse oximetry to detect important underlying disease~     increases significantly if performed several days after birth. This study will provide~     important and novel normative data.~   "
112542|NCT02094365|"~     This study is designed to compare the antiviral effect of ALS-008176 compared to a placebo~     control in the respiratory syncytial virus challenge model.~   "
112543|NCT02094352|"~     The purpose of this study is to determine whether epidural and ketamine infusions are~     effective in the treatment of Complex Regional Pain Syndrome (CRPS).~   "
114042|NCT02074735|"~     The purpose of this study is to determine if citicoline, as an add-on therapy, will help~     reduce alcohol use in outpatients with alcohol dependence.~   "
112491|NCT02095028|"~     Background: Maternal obesity is associated with higher risks of adverse maternal and fetal~     complications, but the effects of dietary and lifestyle interventions on gestational weight~     gain(GWG) and pregnancy outcomes in obese pregnant women are unclear.~      Objective: This study examined whether intensive dietary and lifestyle interventions~     initiated in the early pregnancy could decrease GWG, and prevent relevant adverse pregnancy~     outcomes in Chinese obese pregnant women.~      Design:A randomized controlled trial in obese pregnant women was performed at 6-12 weeks of~     gestation.The sample size was estimated using GWG reduction as the primary outcome variable.~     The investigators pilot study (data not published) showed the gestational weight gain was~     12.73±5.97 for obese women. Assuming intervention may result in 25% (3.1825g) reduction in~     GWG, the estimated sample size with 90% power and type I error of 0.05 was 114 women in~     intervention group and 57 in control group. Adjusting for 15% refusal or loss to follow up~     during pregnancy, the total sample size required was 136 women in intervention group and 68~     in control group(standard care group). Participants were randomly assigned to the control or~     the intervention group. The intervention focused on restricting energy intake combined with~     behavioral lifestyle modification through participation in group sessions and individual~     counseling. The primary outcomes were gestational weight gain (GWG) and secondary outcomes~     were the incidence of gestational diabetes mellitus (GDM), hypertensive disorders during~     pregnancy, large-for-gestational-age (LGA) infants, macrosomia and the rate of caesarian~     section.~      Hypothesis:The intensive dietary and lifestyle intervention performed from the first~     trimester in obese women could decrease total GWG,and perhaps improve relevant pregnancy~     outcomes.~   "
112492|NCT02095015|"~     Mucopolysaccharidosis (MPS) type II (MPS II; Hunter syndrome) is a rare, X-linked disease~     caused by a deficiency of the lysosomal enzyme iduronate-2-sulfatase (I2S) and occurs almost~     exclusively in boys, with an incidence of approximately 1.3 per 100,000 live male births.1~     Early identification of MPS II is challenging because some initial features, such as chronic~     runny nose, otitis media, and hernias, are commonly seen in the general population. As a~     result, even though the signs and symptoms of MPS II typically appear early in childhood, the~     diagnosis may lag behind by several years.~      The primary objective of this international multi-center study is to evaluate the positive~     screening rate of MPS II subjects by screening a high-risk male pediatric population who have~     had or are scheduled for 1 or more specific ENT surgical procedures (adenoidectomy and/or~     tonsillectomy and/or tympanostomy) and who have a previously repaired or present evidence of~     an inguinal and/or umbilical hernia.~   "
112493|NCT02095002|"~     To explore the effect of modified valsalva maneuver on the filling degree of right internal~     jugular vein.~      Method: The anteroposterior diameter and left-right diameter of right internal jugular vein~     in thirty adult gynecology patients were recorded during normal respiration and modified~     valsalva maneuver respectively.~      Investigators hypothesis that modified valsalva maneuver would enchance the filling degree of~     right internal jugular vein.~   "
112494|NCT02094989|"~     The electrocardiogram (ECG) is an important diagnostic procedure in medicine mainly to detect~     circulation disorders and problems of the spread of the electrical heart impulse. It is~     frequently the first measure in clinical practice when angina pectoris, acute myocardial~     infarction or an arrhythmia are suspected. The ECG is easy to perform, safe and cheap.~      Posture changes are known to cause alterations of the ECG [1]. Deviation of the electrical~     heart axis (EHA) [2], temporary changes of the QRS morphology and ST-segment alterations are~     of particular importance in view of diagnostic accuracy [3], [4]. In ambulatory ECG~     recordings ST-segment alterations for instance might mistakenly be interpreted as cardiac~     ischemia [5]. Artifacts could be minimized by the concurrent determination of the deviation~     of the electrical heart axis [6] [7]or by using posture detectors [8] helping to correlate~     ECG changes to posture changes.~      Due to the emergence of new computer based opportunities ambulatory ECG in the sense of home~     monitoring is an emerging market. Together with the superiority compared to the scalar ECG in~     detecting certain pathologies, like myocardial infarction and right ventricular hypertrophy,~     the VCG gained new interest in recent years [9]. Four ECG leads are sufficient to synthesize~     a standard 12-lead ECG from a VCG and vice versa with a transformation matrix [10] [11].The~     redirection of the spatial VCG after posture changes has been determined for the QRS loop~     with the Frank leads, which is the reference method for constructing the VCG [12][13].~      4 leads of an ambulatory ECG are sufficient to construct the VCG if arranged approximately in~     the position of three rectangular axes. Doctors are best trained to interpret standard 12~     lead ECGs. With optimization of the leads of ambulatory (Holter) ECG towards the three~     rectangular axes, this might allow mathematical transformation into the standard 12 lead ECG.~     A precondition would be that the transformation matrix is independent of posture. To date,~     transformation matrix between Frank VCG and standard 12 lead ECG has only been calculated in~     resting ECGs [5].~      This is the first study which investigates the transformation matrix in different postures.~     Additionally, the investigators will investigate for the first time prospectively for known~     artefacts of stress testing and ambulatory ECGs.~      Aim:~      Simultaneous prospective recording of the standard 12 lead ECG and the Frank-lead VCG in~     different postures is expected to add information on potential causes of artifacts of the ECG~     caused by posture changes. During continuous recording, the investigators will investigate~     the accuracy of the linear affine transformation with posture, the occurrence (dimension and~     duration) of ECG/ VCG morphology changes and ST-segment alterations, and VCG angle changes in~     dependence of posture changes in healthy young men.~      Hypothesis The investigators hypothesis is that the transformation matrix between Frank-Lead~     VCG and standard 12-lead ECG is posture dependent.~      Artefacts of the ECG due to posture changes are systematic. The knowledge of the systematics~     improves the diagnostic accuracy of ambulatory ECG and stress testing.~   "
112495|NCT02094976|"~     Increased intra-abdominal pressure(IAP) might influence on perioperative morbidity related to~     increased CVP, PVWP, SVR, PAP and decreased venous return and cardiac output. Prone position~     has been known to increase IAP. In clinical field, various apparatuses has developed to~     minimize IAP elevation during prone position operation.~      In this study, we would compare the changes of IAP and respiratory system compliance~     according to positional apparatus in prone position.~   "
112496|NCT02094963|"~     The purpose of this study is to assess safety and efficacy of Ticagrelor versus Clopidogrel~     in Asian/KOREAn patients with acute coronary syndromes intended for invasive management.~   "
112497|NCT02094950|"~     This is a single arm clinical trial to establish the feasibility of conducting a clinical~     trial of acupuncture in reducing dyspnea among lung cancer survivors who have completed~     chemoradiotherapy. Twelve subjects with dyspnea will be recruited to this clinical trial. Up~     to 10 sessions of acupuncture will be delivered over the course of 8-10 weeks. The primary~     outcome will be dyspnea as measured by the English version of the Cancer Dyspnea Scale at the~     completion of the intervention.~   "
112498|NCT02094937|"~     The primary aim of this study is to clarify the position of FF and FF/Vilanterol (VI) 100/25~     micrograms (mcg) compared with existing therapies by assessing FF dosage equivalent to low to~     middle-dose inhaled corticosteroids (ICS). The study is divided into Run-in period, Period 1~     (open-label treatment), Period 2 (double blind treatment) and Follow-up. Subjects with well~     controlled asthma after completing a run-in period of 4 weeks will be switched from~     middle-dose ICS/long acting beta 2 agonist (LABA) equivalent dose to once-daily FF/VI 100/25~     mcg for an 8 weeks treatment period (Period 1). After this, subjects will be randomized in a~     1:1:1 ratio to receive either FP 250 mcg twice daily, FP 100 mcg twice daily or FF 100 mcg~     once daily in a 12 week double blind treatment period (Period 2). There will be a 1 week~     Follow-up Period following completion of the double-blind treatment period, or early~     withdrawal from the study. Overall , the total duration of subject's participation in the~     study will be for 25 weeks. RELVAR is a registered trademark of the GSK group of companies.~   "
112599|NCT02093611|"~     We hypothesize that adenosine-5'-triphosphate (ATP) supplementation will be able to enhance~     motor unit recruitment while simultaneously blunting the decline in power and reaction time~     that is typically seen during repetitive sprints. This will give researchers a better~     understanding of the mechanism by which ATP supplementation can augment power, especially~     under high fatiguing conditions.~   "
112499|NCT02094924|"~     This study is required to confirm the suitability of a candidate FDC of 16mg candesartan~     cilexetil/12.5mg HCTZ (GSK587323) formulation for further development and provide data to~     allow the design of a future pivotal bioequivalence study. This study aims to determine the~     relative bioavailability of a FDC tablet formulation of 16mg candesartan cilexetil/12.5mg~     HCTZ relative to the reference product of same fixed dose combination (16mg candesartan~     cilexetil/12.5mg HCTZ) in healthy adult humans. This will be an open-label, randomised,~     single dose, two-way crossover study. Each subject will participate in two treatment periods~     and will be randomized to one of two sequences and administered one of the two treatments, A~     or B, as per the randomization schedule. The two treatment periods will be separated by a~     washout period of 7 to 14 days to ensure the candesartan and HCTZ have been effectively~     eliminated from the subject between dosing occasions. The study will enroll 16 healthy~     subjects to ensure that 14 subjects complete the study as planned.~   "
112500|NCT02094911|"~     The overall aim of the project is to evaluate the (cost-)effectiveness of the SLIMMER~     diabetes prevention intervention in Dutch primary health care.~   "
112501|NCT02094898|"~     The purpose of this research study was to find out if the medication known as ketamine could~     help the symptoms of depression. This drug is approved by the U.S. Food and Drug~     Administration (FDA) as an anesthetic agent; however, it is not approved for use in~     depression treatment. The FDA allowed the use of this drug in this research study.~   "
112502|NCT02094885|"~     To evaluate the clinical utility of Bioseal as an adjunct to control bleeding during elective~     vascular surgery.~   "
112503|NCT02094872|"~     This phase II trial studies how well molecularly targeted therapy works in treating patients~     with melanoma that has spread to other parts of the body. Patients must have received or do~     not qualify for prior immunotherapy. Targeted therapy is a type of treatment that uses drugs~     or other substances to identify and attack specific types of cancer cells with less harm to~     normal cells. Molecularly targeted therapy works by treating patients with substances that~     kill cancer cells by targeting key molecules involved in cancer cell growth.~   "
112504|NCT02094859|"~     The primary purpose of this Study is evaluation of the safety and performance of the~     GlucoClear System (System).~      The primary safety objective will be assessed by:~      • Evaluation of any serious adverse device effects upon Sensor insertion through Sensor~     removal and a follow-up assessment one week (7 ± 3 days) after Sensor removal.~      The primary performance objective will be evaluated using the following criteria:~      15/20% Performance: Blood glucose measurements from the System must meet the ISO 15197 15/20%~     accuracy criteria (at least 95% of the matched pairs within ± 15 mg/dL of Comparator values ≤~     75 mg/dL and within ±20% of Comparator values > 75 mg/dL).~   "
112505|NCT02094846|"~     The aim of the study was to assess the effect of an individualized intervention based on cell~     phones to improve glycemic control in patients with type 2 diabetes attending Epidemiology~     Research Unit in Cuernavaca, Morelos. Mexico~   "
112506|NCT02094833|"~     The aim of this study is to evaluate the immunogenicity and safety of a novel DTaP-IPV-Hep~     B-PRP~T fully liquid combined hexavalent vaccine (study vaccine) administered at 2, 4, and 6~     months of age compared to Sanofi Pasteur's DTaP-IPV//PRP~T combined vaccine (Pentaxim™) given~     at 2, 4, and 6 months of age and Hep B vaccine (Euvax B®) given at 1 and 6 months of age in~     South Korean infants that received a birth dose of Hep B and born to mothers documented to be~     serum anti-HBs Ag negative.~      Primary Objective~        -  To demonstrate the non-inferiority in terms of seroprotection (Diphtheria, Tetanus,~          poliovirus types 1, 2, and 3, PRP-T, Hep B) and vaccine response for pertussis antigens~          (pertussis toxoid [PT] and filamentous haemagglutinin [FHA]) of Group A versus Group B,~          one month after the third dose of combined vaccines.~      Secondary Objectives:~        -  To further study the immunogenicity of the two vaccination schemes, before the first~          dose and one month after the last dose of vaccines.~        -  To study the safety after each and any dose of vaccines administered in the two~          vaccination schemes~   "
112507|NCT02094820|"~     Objectives: Chronic Fatigue Syndrome (CFS) is a medically unexplained condition characterized~     by severe and disabling fatigue. To date much research has focused on finding out whether CFS~     is caused by mainly physical or psychological factors. Perhaps as a result of this, few~     studies have examined the relationship between CFS and quality of life, in particular, more~     positive aspects of mental health, such as an individual's sense of purpose, autonomy and~     close relationships.~      This study will address these limitations by examining Ryff's (1989) six domains of~     psychological well-being (PWB), and other aspects of well-being including positive emotions,~     in CFS. It will also examine the relationship between measures of symptomology, emotional~     distress and PWB.~      Method: This is a cross-sectional, questionnaire-based study with a clinical sample of adults~     with CFS. Participants will complete valid measures of well-being and symptomology.~      Results: We expect to find that compared to general population norms, individuals with CFS~     score lower on measures of PWB. Secondly, we expect PWB dimensions will be related to symptom~     measures. There are however, no grounds for making strong predictions.~      Implications: This study will advance our understanding of quality of life in CFS.~     Clinically, it has the potential to enrich and inform therapeutic interventions.~   "
112508|NCT02094807|"~     The purpose of this prospective randomized controlled study is to determine whether acute and~     chronic pain in patients who suffer multiple traumatic rib fractures is decreased after~     surgical management as compared to conservative management.~   "
112509|NCT02094794|"~     This phase II trial studies the safety and efficacy of total marrow and lymphoid irradiation~     (TMLI) in combination with two chemotherapy drugs, etoposide and cyclophosphamide, as a~     preparative regimen before donor stem cell transplant in treating patients with high-risk~     acute lymphocytic leukemia (ALL) or acute myeloid leukemia (AML) who have failed previous~     therapy. Intensity-modulated radiation therapy (IMRT) uses imaging to provide a~     three-dimensional view of the area to be irradiated. Doctors can then shape and direct the~     radiation beams at the area from multiple directions while avoiding, as much as possible,~     nearby organs. TMLI is a method of using IMRT to direct radiation to the bone marrow.~     Radiation therapy is given before transplant to suppress the immune system, prevent rejection~     of the transplanted cells, and wipe out any remaining cancer cells. TMLI may allow a greater~     radiation dose to be delivered to the bone marrow as a preparative regimen before transplant~     while causing fewer side effects than standard radiation therapy.~   "
112511|NCT02094768|"~     Much attention has been directed at the unhealthy effects of sugar-sweetened beverages~     (SSBs), as an increase in their consumption has paralleled the rise obesity rates. In adults,~     SSBs have been shown to promote ectopic fat storage and raise plasma triglycerides compared~     to equivalent amounts of semi-skim (1.5%) milk, water, or diet beverages. Replacement of soda~     with milk had the added benefit of also reducing systolic blood pressure. While several~     studies have investigated the effects of SSBs on weight gain in children, no published~     studies have investigated their effects on lipid and lipoprotein risk factors under~     isocaloric conditions in metabolically at-risk adolescents, who are among the greatest~     consumers of SSBs. The main objective of this study is to test whether isocaloric replacement~     of soda with reduced fat milk will significantly improve atherogenic dyslipidemia, blood~     pressure, insulin sensitivity, and liver function in overweight and obese adolescents who are~     habitual soda consumers. The investigators will test this in a 8 week randomized two period~     crossover trial in 30 overweight and obese adolescent males who are self-reported habitual~     consumers of SSBs. Participants will consume energy equivalent amounts of SSB (24oz soda~     containing high fructose corn syrup per day), and reduced fat milk (2% milk fat) for 3 weeks~     each, in random order, separated by a 2-week washout. Anthropometrics, blood pressure, and~     blood samples will be collected at screen and at the end of each intervention period. Plasma~     measurements will include LDL peak particle diameter; lipoprotein subclass concentrations;~     triglycerides; total, LDL, and HDL-cholesterol; apolipoproteins; glucose, insulin, and~     insulin resistance; high sensitivity C-reactive protein; uric acid; and liver enzymes.~   "
112512|NCT02094755|"~     Critical Limb Ischemia (CLI) is defined as limb pain that occurs at rest, or impending limb~     loss that is caused by severe compromise of blood flow to the affected extremity. CLI is a~     major cause of death and disability (secondary to myocardial infarction, stroke and~     amputation). The mortality in patients with CLI approaches 25% and 50% at one and five years~     respectively. High on-treatment platelet reactivity (HPR) in patients treated with aspirin~     and clopidogrel (previously referred to as resistance) is associated with an increased risk~     of recurrent cardiovascular events after percutaneous coronary interventions and acute~     coronary syndromes. The prevalence and significance of HPR in patients with critical limb~     ischemia treated with aspirin and/or clopidogrel is not known.~      The investigators project aims to investigate the prevalence of HPR (to aspirin and~     clopidogrel) in one hundred patients with diagnosis of critical limb ischemia encountered at~     University of Southern California affiliated hospitals (Los Angeles County Hospital and Keck~     Hospital of USC).~   "
112513|NCT02094742|"~     This pilot study examines the feasibility and turnaround time of performing and obtaining~     data from a few key molecular assays. These assays will be performed using different~     laboratories and technologies from core biopsies taken from patients diagnosed with invasive~     recurrent or metastatic breast cancer. All results will be uploaded, stored and assessed~     using the IT Molecular Screening Prototype Platform (MSPP). The MSPP will also be evaluated~     for ease of use to screen patients for participation in future molecularly defined clinical~     trials in breast cancer.~   "
112514|NCT02094729|"~     The purpose of this study is to assess the safety, tolerability, pharmacokinetics,~     immunogenicity, and pharmacodynamic response of repeated intravenous infusions of BAN2401 in~     subjects with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild~     Alzheimer's disease.~   "
112515|NCT02094716|"~     To determine and compare the safety and efficacy of permethrin foam 4% and permethrin foam 5%~     with that of vehicle in subjects with scabies.~   "
112516|NCT02094703|"~     The efficacy of Solifenacin Succinate 5 mg as adjuvant therapy and levofloxacin (500 mg) for~     short-term treatment to reduce symptoms in patients with symptomatic non complicated urinary~     tract infection in females.~   "
112517|NCT02094690|"~     The purpose of this study is to assess the effect of two protocols of physiotherapeutic~     exercises in the maintenance and/or increase of the mandibular range of movement in patients~     suffering from head and neck cancer (HNC) who are undergoing radiotherapy.~   "
112518|NCT02094677|"~     The objective of the study is to compare the overall subjective preference between two Daily~     Disposable hydrogel lenses when refitted into a third hydrogel lens.~   "
112519|NCT02094664|"~     The purpose of this study is to compare heat and humidified oxygen with cold and dry oxygen~     in children with bronchiolitis.~      The hypotheses are that heating and humidifying inspired low flow supplemental oxygen will~     optimize mucociliary function thereby, 1) improve oxygenation, 2) decrease work of breathing,~     and 3) decrease length of hospital stay.~   "
112520|NCT02094651|"~     The purpose of this study is to determine if treatment of epileptiform abnormalities in~     children with autism spectrum disorder will improve any behaviors in these children. The~     investigators will study a number of different behavioral outcomes including behaviors~     related to attention, social communication, repetitive behaviors, maladaptive behaviors,~     language, motor and sensory, and sleep. The investigators will use an anticonvulsant~     medication called valproic acid (in the form of sodium divalproex).~   "
112521|NCT02094638|"~     Tanreqing Injection is widely used in respiratory disease with Chinese medicine syndrome of~     retention of phlegm and heat in Fei. This study record clinical use of Tanreqing Injection in~     the real world, observe the adverse drug reactions/ adverse drug events during treatment, and~     figure out why Tanreqing induced severe allergic reaction happens.~   "
112522|NCT02094625|"~     Cisplatin is a key chemotherapy agent for the treatment of multiple childhood cancers but~     causes permanent hearing loss. This study investigates the drug N-acetylcysteine (NAC) to~     determine the dose necessary to protect hearing and also how well tolerated NAC is when~     combined with chemotherapy.~   "
112523|NCT02094612|"~     The study goal is to examine whether the use of an objective computerized neuroassessment~     (the Quotient System) for Attention-Deficit/Hyperactivity Disorder (ADHD) is related to~     improved outcomes among pediatric patients being assessed and treated for ADHD.~   "
112524|NCT02094599|"~     The primary objective of this study is to evaluate the abuse potential of dronabinol oral~     solution in recreational cannabinoid users.~   "
112525|NCT02094586|"~     The primary goal of this Phase III study is to compare 3 lots for consistency of manufacture.~   "
115192|NCT02059681|"~     The purpose of this study is to evaluate whether endocavitary intramyocardial injection of~     autologous bone-marrow-derived CD133+ cells is safe on the basis of number of adverse events,~     with follow-up assessments extending up to 1 year after enrolment.~   "
112531|NCT02094508|"~     Background:~      - Malaria is a disease that affects many children and adults in Uganda and Africa. If it is~     not treated, it can make some people severely ill. TMP-SMX (Trade names Bactrim, Septrin) is~     a drug that is given to children born to HIV-positive mothers to help prevent infection.~     Studies have shown that TMP-SMX also may kill malaria infection in the very early stages of~     infection in the body, which may positively impact the way the body can fight malaria~     infection. Researchers want to know if giving TMP-SMX for 6 months longer than usual helps~     children fight malaria better in this way.~      Objective:~      - To find out if taking TMP-SMX for longer than usual helps fight off malaria in infants.~      Eligibility:~      - Infants 0-6 weeks of age who are HIV negative.~      Design:~        -  Infants will be screened with a medical history and physical exam. A small amount of~          blood will be taken. The mothers medical records will be reviewed. Mothers will be asked~          about when they breastfeed.~        -  Participants will take TMP-SMX according to their doctor s orders. In Uganda, mothers~          will get a mosquito net with insecticide on it as per standard of care.~        -  Participants will come to the clinic once a month, every month, until the study ends in~          2 3 years. Each visit will repeat the screening visit.~        -  Participants will also visit the clinic every month for a medical history, physical~          exam, and different blood tests.~        -  Six weeks after breastfeeding is stopped, children taking TMP-SMX will come into the~          clinic and will either be taken off the drug or will continue taking the drug for 6 more~          months.~        -  If a child becomes sick, it is important that the mother bring him or her to the RHSP~          clinic in Rakai.~   "
112532|NCT02094495|"~     The aim of this study are to to evaluate the knowledge and understanding on tamoxifen~     theraphy for breast cancer patients and examine the decision conflict scale and satisfaction~     with decision scale while making decision to take tamoxifen.~   "
112533|NCT02094482|"~     The new OSAS Implant is intended for use in the palate (hard and soft palate/ see picture~     above) in order to stiffen and stabilize the soft palate, which may reduce the severity of~     airway obstructions and of snoring in patients suffering from OSA (Obstructive Sleep Apnea).~     Indications for use of the System include: symptomatic, habitual, social snoring due to~     palatal flutter or upper airway obstruction primarily caused by the retropalatal obstruction.~     The System is labeled for use by physicians only.~      The primary endpoint is the Apnea-Hypopnea-Index (AHI) in the 90 days follow-up.~      Study hypothesis: Reduction of initial AHI ≥20%~   "
112534|NCT02094469|"~     This study will be conducted in accordance with the local regulation of New Drug Application.~     Overall duration of this trial will be 3 years after approval of MFDS.~      Each subject will participate around 26 weeks, which include the 24 weeks treatment period~     and 2 weeks safety follow up period. Withdrawn subjects due to efficacy after 4 weeks~     treatment will participate in 6 weeks in total including 2 weeks safety follow up. Withdrawn~     subjects with other reason also have 2 weeks follow up period.~   "
112535|NCT02094456|"~     Diverticular bleeding is the most common cause of acute lower gastrointestinal bleeding~     (LGIB) in Western populations. Although self-limited in 85% of cases, some patients may~     require hospitalization with blood transfusion and emergent intervention, with significant~     associated morbidity and mortality. Up to 25% of patients with an initial bleeding episode~     will have subsequent episodes.~      Diverticula form at weak points along the colon wall, where the vasa recta enter the circular~     muscle layer of the colon. Diverticular bleeding is attributed to thinning of the blood~     vessels as they cross over the dome of a diverticulum. Endoscopic clipping of actively~     bleeding colonic diverticula has been recognized as a safe and effective treatment for acute~     LGIB since the mid1990s. Patients selected would have had previous colonoscopy to exclude~     other causes of bleeding (e.g. angiodysplasia, colorectal cancer).~      The investigators propose prophylactic elective endoscopic diverticular clipping in patients~     who have had at least 1 episode of acute LGIB requiring hospitalization. This would involve~     applying endoscopic clips to the base of every diverticula in a patient's colon, such that~     any bleeding source would effectively be excluded. The investigators would later reevaluate~     patients for colonoscopic appearance of diverticula to assess their diverticular disease.~      The investigators hypothesize that patients undergoing endoscopic diverticular clipping will~     not have repeat episodes of bleeding.~   "
112536|NCT02094443|"~     The primary purpose of this study is to evaluate the pharmacodynamic (i.e. hepatitis C virus~     (HCV) viral load), pharmacokinetic and safety profiles between two treatment groups receiving~     different doses of DEB025 in combination with ribavirin (RBV) during the first 12 weeks~     treatment in chronic hepatitis C genotype (GT)-2 and GT-3 patients who had previously failed~     interferon therapy or were intolerant or unable to take interferon.~   "
112537|NCT02094430|"~     The aim of the study is to evaluate clinical pharmacology, efficacy and safety of FGTW in~     pediatric patients with congenital fibrinogen deficiency.~   "
112538|NCT02094417|"~     The present study will be conducted to evaluate the efficacy and safety of AMG531 and to~     determine the recommended initial dose of AMG531 on the basis of its efficacy and safety when~     it is administered subcutaneously (SC) to the Aplastic Anemia (AA) patients with~     immunosuppressive-therapy refractory thrombocytopenia and also to assess the pharmacokinetics~     of this product. Its efficacy and safety during the extension period beyond one year will~     also be evaluated.~   "
112539|NCT02094404|"~     Currently, the Manchester Triage System (MTS) is used to triage all children presenting at~     the emergency department(ED) in this hospital. This system has been proven safe, but many~     patients are classified as too urgent. In this hospital adults are prioritised at the ED by a~     score based on vital signs, the early warning score. A similar score is developed suitable~     for children. This score, the Pediatric Early Warning Score (PEWS), is already used to~     determine clinical deterioration.~      The investigators hypothesize that children can be triaged safely with the PEWS.~      If it is safe, there will be one triage system again at the ED. Another advantage will be~     more continuity in assessing the condition of patients who are admitted to the hospital.~   "
112540|NCT02094391|"~     Isolated limb perfusion (ILP) results in good response rates for locally advanced melanoma~     (stage IIIB and IIIC, AJCC 2009). Outcome is influenced by stage of disease, reflecting the~     aggressiveness of the melanoma. Our objective is to demonstrate at least a doubling of the~     progression free survival for the patients having an adjuvant treatment by Ipilimumab in this~     patient population with unfavourable characteristics. PFS ranges from 10-12 months. So at~     least a doubling of this period would be a clinically highly significant result.~   "
112544|NCT02094339|"~     Postoperative pain after total knee arthroplasty (TKA) can be difficult to manage and may~     delay recovery. There are multimodal postoperative pain management after TKA, including~     intravenous opioids, epidural analgesia, peripheral nerve blocks or periarticular~     infiltration with local anesthetics. All of these treatments may lead to side effects such as~     nausea, headache, hypotension, urinary retention, partial motor block and infection of the~     knee. Therefore the investigators will compare three methods of postoperative analgesic after~     TKA by their efficiency and complication.~   "
112545|NCT02094326|"~     The purpose of this study is to find patterns in the use of non-biological DMARDs as the~     initial treatment of RA and how adverse events (AEs), intolerance or lack of efficacy may~     impact therapeutic decisions in real life in the Spanish Andalusian region.~   "
112546|NCT02094313|"~     Recently, concerns about the effect of atorvastatin intake on men fertility have been raised.~     However, this statin has never been investigated regarding its influence on male fertility,~     notably sperm quality.~      The aim of this pilot study is to evaluate the efficacy and the safety of a decrease of~     cholesterol blood levels, induced by taking atorvastatin, on sperm quality of~     normocholesterolaemic and healthy men without confounding factors.~   "
112547|NCT02094300|"~     The Zenith® Dissection Clinical Trial is a clinical trial approved by US FDA to study the~     safety and effectiveness of the Zenith® Dissection Endovascular System in the treatment of~     patients with aortic dissection.~   "
112548|NCT02094287|"~     The study is initiated in the indication of atopic dermatitis to study the impact of placebo~     in the treatment of pruritus. Classical conditioning and expectation via~     instructions/anticipation maintain the effect of placebo.~   "
112549|NCT02094274|"~     The purpose of this study is to assess the the ability of a single dose of LAS40468~     administered via Genuair® and a single dose of salmeterol/fluticasone propionate (Seretide®)~     administered via Accuhaler to produce bronchodilation (opening of the airways) and the safety~     and tolerability of the treatments~   "
112550|NCT02094261|"~     A Phase II, Open Label, Single-arm Study to Assess the Safety and Efficacy of AZD9291 in~     Patients with Locally Advanced/Metastatic Non Small Cell Lung Cancer whose Disease has~     Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy~     and whose Tumours are Epidermal Growth Factor Receptor Mutation and T790M Mutation Positive~   "
112551|NCT02094248|"~     The primary objectives of this study are to assess the impact of rhTPO on mortality among~     severe sepsis patients with thrombocytopenia, as well as changes of platelet counts and~     platelet transfusion rates.~   "
112552|NCT02094235|"~     This is a multicenter, double-blind, vehicle-control study of 0.05% and 0.2% E6005 ointment.~     Pediatric subjects with atopic dermatitis (AD) will be grouped into two; an elder group~     (childhood - adolescent: 7 to 15 years of age) and a younger group (children: 2 to 6 years of~     age) according to the sequential cohorts by confirming the safety.~   "
112553|NCT02094222|"~     Byler Disease is the result of a homozygous missense (G308V) mutation in the ATP8B1 gene. The~     disease is typically manifest in the first year of life on the basis of complications of~     cholestasis; common presentations include jaundice, poor growth, bleeding related to vitamin~     K deficiency, and/or weak bones related to vitamin D deficiency. Early management of Byler~     Disease is directed at nutritional issues which tend to be responsive to medical~     intervention, unlike the pruritus/scratching which remains a devastating problem. Progressive~     liver disease develops in Byler Disease and can lead to cirrhosis and end-stage liver~     disease. This is an open label expanded access protocol of RAVICTI in children with Byler~     Disease. The primary hypothesis is that the administration of RAVICTI in these children is~     feasible, well tolerated and safe. It is also hypothesized that RAVICTI treatment leads to an~     improvement in biochemical markers of liver disease and it may ameliorates or prevents the~     development of scratching behavior as a manifestation of pruritus attributed to the liver~     disease.~   "
112554|NCT02094209|"~     20 patients having received an AO large external fixator at the tibia will be equipped with a~     data logger device (AO Fracture Monitor) attached post-operation to a connection rod of the~     external fixator. The device continuously measures deformation of the fixator frame due to~     weight bearing for up to 6 months by means of a strain gauge. Several parameters are~     calculated from the recorded change in the strain signal and are stored at a regular~     interval.~   "
112555|NCT02094196|"~     The aim of this project is to assess reward- based learning behavior and its association with~     alterations in dopaminergic and glutamatergic transmission in detoxified alcohol-dependent~     patients and matched controls.~      The investigators will explore how these alterations interact with clinical and psychosocial~     factors which can modify the relapse risk and learning deficits.~      Patients will be detoxified in an inpatient setting. Clinical assessments, behavioral~     paradigms of learning and brain imaging will be carried out within at least 4 half- lives~     after any psychotropic medication.~      The investigators will implement and apply functional imaging paradigms assessing~     Pavlovian-to-instrumental transfer and reversal learning tasks and associate model parameters~     of learning with alcohol craving, intake and prospective relapse risk.~      In this project, the impact of the dopamine x glutamate interaction on learning deficits and~     consecutive relapse probability is targeted with [18F]fallypride PET and the measurement of~     absolute concentrations of glutamate with magnetic resonance spectroscopy (MRS).~   "
112556|NCT02094183|"~     Glucagon Like Peptide (GLP) -1 affects metabolic response corrected for weight change~   "
112557|NCT02094170|"~     The prevalence of overweight and obesity are increasing worldwide. In the U.S., approximately~     85,000 new cancer cases per year are related to obesity. Understanding lifestyle behaviors,~     their causes, and relations to cancer are critical. Where people spend their time during the~     day may be related to their risk of getting cancer. This project will assess behaviors in~     different locations across the day and relate exposure to different environments to~     biological outcomes.~   "
112612|NCT02093442|"~     Endometrial injury performed in a cycle preceding the one for embryo transfer is associated~     with an increased implantation and pregnancy rate when carried out during the month preceding~     that of ovulation induction and fresh embryo transfer. However, there is no evidence about~     the effect of this intervention on the transfer of cryopreserved embryos.~   "
112613|NCT02093429|"~     The study design includes a 3-dose randomization phase to determine effective doses of~     INCB047986 in patients with myelodysplastic syndrome (MDS) who are refractory or unlikely to~     respond to erythropoiesis-stimulating agents (ESAs) followed by an extension phase.~   "
112558|NCT02094157|"~     Approximately 2 million patients in North America are currently treated with the blood~     thinner warfarin. These patients have every year more than 200,000 invasive procedures, for~     which warfarin must be stopped to avoid bleeding complication. To protect the patient against~     blood clots and stroke while warfarin is stopped, most physicians today order bridging with~     low-molecular-weight heparin (LMWH). This is another blood thinner and it is injected under~     the skin during 3 days before the procedure. For implantation of pacemaker or defibrillator~     (27,000/year in Canada) the bridging routines vary a lot.The common bridging treatment~     with LMWH for 3 days before pacemaker surgery causes bleeding in the pocket where the~     pacemaker is placed in about 5%. For comparison, patients not on any blood thinners develop~     this bleeding in 2% after this surgery. Pocket bleeding may require evacuation of the blood~     collection and may cause infection. Pocket bleeding is thus a fairly common and clinically~     important but rarely a dangerous bleeding complication. It is a suitable safety endpoint in a~     study of bridging of blood thinners. LMWH costs $80-120, for which some patients are not~     covered. They have to be taught self-injection technique or have a nurse come to their home.~     The main hypothesis is if patients on blood thinners can be managed more conveniently before~     and after pacemaker surgery, without injections, without increased risk of pocket bleeding.~   "
112559|NCT02094144|"~     Community-dwelling women aged 55 or over are recruited at public meetings aimed at promoting~     physical activity in postmenopausal women. Women are eligible and enrolled in the study if~     they have no significant disease affecting lower limb function and if they have a sedentary~     lifestyle. All study participants provide written informed consent to participate to the~     study.~      Women are then randomized either to the control group (women have to maintain their~     lifestyle) or to the exercise group : 40 minutes of brisk walking 3d/wk for 6 months (two~     supervised sessions and one session performed one their own per week with a detailed~     program). The intensity of the program is adapted to the heart rate work and gradually~     increases over the 6-month program. The objective of the study is to determine the health~     benefits of brisk on walking ability, diet, muscle strength, balance, blood pressure, bone~     density, body weight, lean and fat mass, depression symptoms, behavioral, emotional~     responses, sleep quality, and biological indicators of health.~   "
112560|NCT02094131|"~     Experimental Procedure: The subjects underwent an initial interview in which was filled in a~     form of anamnesis, in addition to being assessed and reassessed by spirometry, dynamic~     circumference and manometer. Moreover, responded international physical activity~     questionnaire (IPAQ - short version) in order to characterize the physical activity level of~     each participant being classified as inactive, irregularly active, active, and very active.~     The same examiner performed the assessments and reassessments of individuals after a training~     program.~   "
112561|NCT02094118|"~     This study is designed to determine if point-of-care washing of allogeneic Leukocyte-Reduced~     Red Blood Cells reduces pulmonary complications when compared to standard-of-care~     Leukocyte-Reduced Red Blood Cells in a cardiac surgical population.~   "
112562|NCT02094105|"~     Importance: There are no global screening recommendations for esophageal squamous cell~     carcinoma (ESCC). Endoscopic screening has been investigated in high incidence areas of China~     since 1970's. But up until now there no apparent evidence that would lead to a reduction in~     disease morbidity and mortality.~      Objective: To evaluate whether endoscopic screening and early intervention program could~     reduce the incidence or mortality of ESCC.~      Design: Community-based, controlled cohort study among 45 386 residents, Endoscopy screening~     was completed from November 1999 to May of 2000. Subjects in intervention group were examined~     once during intervention period. The study follow-up concluded in December 2009.~      Setting: High risk area of ESCC in China~      Participants:Cluster sampling from communities with high rates of esophageal cancer. A set of~     villages with was selected as the study intervention community. Age 40 to 69 years residents~     were selected as an eligible population. Another set of villages was select as the control~     population. Buffer villages were set up between intervention and control group.~      Intervention: Endoscopy with Lugol's iodine staining and early treatment on precancerous~     lesions was undergone for the intervention group.~      Main Outcome(s) and Measure(s): Incidence and mortality ESCC~   "
112563|NCT02094092|"~     This study will work on hypothetical assumption that compared to the arm supplemented with~     placebo (control) group; the L reuteri (intervention) group will lower daily crying/fussing~     time per 24 hours at one month post randomization. And that the L reuteri (intervention)~     group at 7, 14, 21, days and 1 week after the therapy cessation will have:~        -  Lower crying/fussing time per 24 hours.~        -  Relief from colic pain~        -  Longer sleep duration,~        -  Higher scores on a standardized measure of maternal mental health~   "
112564|NCT02094079|"~     The aim of the study was to evaluate the clinical control program in patients with~     hypothyroidism during pregnancy (suggested in resent guidelines). Is it possible by~     monitoring the patients every 4. week during pregnancy to keep the thyroid function~     parameters within the recommended range?~      A retrospective study of consecutive pregnant women with hypothyroidism followed at the~     outpatient clinic at the Endocrinology Unit, Herlev Hospital, Denmark during 2012. Patients~     selected through electronic medical system. Blood tests for the The hormone levels drawn from~     the laboratory of Clinical Biochemical Department, Herlev Hospital~   "
112565|NCT02094066|"~     The aim of this study is to investigate the effects of tranexamic acid on hemorrhage, blood~     transfusion, fibrin degradation products and kidney functions for total hip arthroplasty.~   "
112566|NCT02094053|"~     The purpose of this double-blind, placebo-controlled, comparative study and open-label~     extension study is to confirm the efficacy and safety of E2020 in subjects with Down syndrome~     having regression symptoms and disabled activities of daily living.~   "
112567|NCT02094040|"~     The purpose of this study is to determine whether discharge follow-up visit by primary~     physician and community-based nurse affects the risk of early re-hospitalisation among high~     risk older people discharged from a medical ward.~   "
112568|NCT02094027|"~     To demonstrate the effectiveness of an easily administered intervention (guided self help)~     aimed at reducing binge eating in patients undergoing bariatric surgery.~      The investigators hypothesize that patients who have guided self help pre-operatively will~     have reduced episodes of bingeing pre-operatively compared to those having treatment as usual~     (bariatric surgery), which will be maintained in the post-operative period, and will be~     associated with improved weight loss and psychological outcomes after surgery.~   "
112569|NCT02094014|"~     Impaired speech production is a major obstacle to full participation in life roles by stroke~     survivors with aphasia and apraxia of speech. The proposed study will demonstrate the~     short-term effects of auditory masking on speech disfluencies and identify individual factors~     that predict a positive response, enabling future work to develop auditory masking as a~     treatment adjuvant targeting long-term improvement in speech. Providing an additional~     treatment option for adults with aphasia and apraxia of speech will have the clear benefit of~     improving quality of life and allowing individuals to participate more actively in their~     health care decisions through improved communication.~   "
112570|NCT02094001|"~     Chronic thromboembolic Pulmonary hypertension(CTEPH) is characterized by obstruction of the~     pulmonary vasculature, leading to increased pulmonary vascular resistance, progressive~     pulmonary hypertension (PH) and right ventricular failure- most common cause of death for~     patients with PH. Riociguat, (ADEMPAS) is a member of a new class of drug recently approved~     in Canada for the treatment of CTEPH.~      This pilot study is designed to assess if at least 24 weeks of treatment with riociguat will~     show changes in glucose metabolism and improved resting myocardial blood flow using positron~     emission tomography ( PET ) imaging to measure myocardial function. The response between both~     treatment naive patients as well as patients on maximally tolerated dose of riociguat with~     tratment duration of at least 3 months will be included.~   "
112571|NCT02093988|"~     Our study will evaluate the use of topical and intravenous (IV) Tranexamic Acid (TXA) in~     spine surgery. The purpose of TXA is to prevent clotting during surgery to reduce blood loss.~     When used intravenously, it has been shown to safe, efficacious, and effective in reducing~     transfusion requirements and blood loss in spine surgeries. We want to evaluate the effect of~     using TXA topically and intravenously to see if it further reduces blood loss in children~     undergoing major surgery compared to IV TXA only~   "
112572|NCT02093975|"~     Physician manned rapid response vehicles are a limited resource in the prehospital handling~     of acute patients.~      In this study mobile videoconferencing between ambulances and the rapid response vehicles~     enables patient consultation at a distance. Video consultation between patient and the~     prehospital physician can take place when the patient is at home or in the ambulance.~      The primary aim of this study is to examine the effect of video consultation between~     physician manned rapid response vehicles and patients receiving treatment by ambulance~     personnel on the number of patients receiving final treatment on-site in the pre-hospital~     setting~   "
112573|NCT02093962|"~     The purpose of this study is to determine whether TH-302 in combination with pemetrexed is~     safe and effective in the treatment of non-squamous non-small cell lung cancer.~   "
112574|NCT02093949|"~     To evaluate a new AF Substrate mapping method based on automatic high density CFAE detection~     with a multipolar catheter (Pentaray) and the  SCI 30-40  setting of CARTO CFAE algorithm.~   "
112575|NCT02093936|"~     Background: Induced sputum (IS) is a noninvasive methodology for evaluating airway~     inflammation in a large number of pulmonary diseases, i.e, Asthma, Chronic obstructive~     pulmonary disease and Interstitial Lung Diseases. Several studies have defined normal values~     and cut-off points for this technique based on cellular components of IS, such as percentages~     of eosinophils, neutrophils, macrophages and CD4/CD8 ratio of T cell lymphocytes. However,~     normal values and cut-off points for lymphocyte percentages indicative of pathology have not~     yet been established or validated. This component of IS has considerable clinical value.~     Similar to other constituents of IS, it can provide biological insights into the pathogenesis~     of respiratory disorders and contribute to establishing the diagnosis and guiding treatment~     management of a variety of airway diseases.~      The purposes of this study are to define normal values and cut-off points of lymphocytes in~     IS among individuals with respiratory disorders and healthy volunteers, and to verify the~     current reference values of the percentage of eosinophils, neutrophils and CD4/CD8 ratio in~     IS.~      Methods: A Cross Sectional study which includes a database on up to 900 patients who~     participated in various studies conducted in the Pulmonary Laboratory of Tel Aviv Sourasky~     Medical Center between 2005 to 2012 will be established. The study population will include~     patients diagnosed as having various pulmonary diseases and a group of healthy volunteers who~     will serve as controls. The cut-off for normal values of lymphocyte, eosinophil and~     neutrophil percentages and CD4/CD8 ratio in IS will be defined by using ROC curves and~     evaluating sensitivity and specificity. The comparison of the different values to those in~     the literature will be done by using the Spearman rank correlation.~      The results of this study will provide supplementary information on lymphocyte counts in IS~     for identifying and treating various respiratory diseases.~   "
112576|NCT02093923|"~     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetic~     profile of multiple subcutaneous administrations of DX-2930 across a range of doses in~     Hereditary Angioedema subjects.~   "
112577|NCT02093910|"~     Bortezomib was an important drug in the treatment of multiple myeloma (MM),and peripheral~     neuropathy (PN) is a significant dose-limiting toxicity of bortezomib that typically occurs~     within the first courses of bortezomib, reaches a plateau at cycle 5. Up to now, no effective~     prophylaxis have been developed for PN. Monosialotetrahexosylganglioside, a nerve-protecting~     drug,was often used to promote growth of nerve, and function restoration of damaged~     nerve.Thus,the investigators hypothesized that combination of~     Monosialotetrahexosylganglioside and bortezomib can reduce the incidence rate of peripheral~     neuropathy (PN) and promote the relief of peripheral neuropathy (PN) in multiple myeloma (MM)~     patients.~   "
112578|NCT02093897|"~     This is an international, multicenter, open-label study to assess the efficacy, safety, and~     pharmacokinetic (PK) profile of rVIII-SingleChain in pediatric patients with severe~     hemophilia A. A minimum of 25 previously treated subjects ≥ 6 to < 12 years of age and at~     least 25 subjects < 6 years of age who have undergone > 50 exposure days (EDs) with a~     previous Factor VIII (FVIII) product are planned to be enrolled. Subjects will be assigned to~     either an on-demand or prophylaxis treatment regimen and will receive rVIII-SingleChain at a~     dose to be determined by the investigator. Hemostatic efficacy will be assessed by the~     subject/caregiver and the investigator who will assess overall efficacy by a 4-point scale.~   "
112579|NCT02093884|"~     The objective of this study is to develop and test an emergency department (ED)-based~     intervention which uses text messages to facilitate contraception initiation.~   "
112580|NCT02093871|"~     To confirm the safety of 6 cycles of Perfusion Induced Systemic Hyperthermia (PISH) provided~     every 28 days in 3rd line ovarian cancer patients.~   "
112581|NCT02093858|"~     Almost all of antipsychotics can induce metabolic syndrome,Genetic factors play a key role in~     the development of metabolic syndrome,TCF7L2 and SLC30A8 are strongestly correlated with~     metabolic syndrome.Moreover,Antipsychotics have an effect on the expression of TCF7L2 and~     SLC30A8 genes.It indicates the variations of TCF7L2 and SLC30A8 play an important part in the~     development of antipsychotics-induced metabolic syndrome.~   "
112582|NCT02093845|"~     The purpose of this study is to perform a randomised comparison between the SYNERGY and the~     Biomatrix NeoFlex stents in treatment of unselected patients with ischemic heart disease.~   "
112583|NCT02093832|"~     This study had four aims:~        1. To evaluate the correlation between the planned preoperative cup size and the actual cup~          size that was implanted in surgery.~        2. To examine the absolute difference between the implanted cup size diameter and the~          actual femoral head size diameter.~        3. To examine the absolute difference between the planned cup size diameter and the actual~          femoral head size diameter~        4. To suggest an additional online monitoring tool on the accuracy of the preoperative~          process and implant selection. We hypothesized that high accuracy rates will be found~          between the preoperative planned cup size and the actual implanted cup size.~          Furthermore, we hypothesized that strong correlations will be found between the planned~          and actual implanted cup size and the actual femoral head diameter size.~   "
112584|NCT02093819|"~     To investigate the safety and tolerability of BI 416970 and to assess the pharmacokinetics~     (PK) of single rising doses of BI 416970. A further objective is to assess the influence of~     CYP2C9 phenotype on the PK of BI 416970.~   "
112585|NCT02093806|"~     The purpose of this study is to measure the size of the round window niche and its relation~     to the mastoid segment of the facial nerve and the mastoid cortex, using high resolution~     computerized tomography of the temporal bone, in order to assess preoperatively what is the~     extent of obstruction of the round window membrane and whether there is a surgical~     possibility of round window approach in the insertion of electrode array into the cochlea~   "
112586|NCT02093793|"~     To evaluate the safety and effectiveness of the Precision Spinal Cord Stimulator Systems~     Adapted for High-Rate Spinal Cord Stimulation as an aid in the management of chronic~     intractable pain~   "
112587|NCT02093780|"~     In the present study, ulcerative colitis (UC) patients in the remission stage of the disease~     will be randomized into two groups: Alberta anti-inflammatory diet and Canada's Food Guide~     diet. The elements of Alberta anti-inflammatory diet have previously been shown to have a~     role in decreasing the risk of UC development or management of UC-related symptoms or~     relapse. Since the primary outcome of interest is the relapse rate in two groups, disease~     status will be assessed monthly using appropriate tools. In order to find out the underlying~     mechanisms that will relate the proposed diet to decreased flare rate, some laboratory~     evaluations, which are mainly markers of inflammation or are related to gut microbiome will~     be conducted. In the present study, the investigators will also perform state-of-the art~     metabolomics tests, in order to study how the dietary changes will change the end~     metabolites. In addition, the investigators will be able to explore if metabolomic profile of~     participants can predict future UC relapse. This study will last for 6 months from baseline~     wherein all the study subjects will receive appropriate dietary instructions in addition to~     their stable doses of maintenance drug therapy.~   "
112588|NCT02093767|"~     Based on the efficacy of inulin and oligofructose in treating experimental colitis and~     emerging evidence suggesting probiotics are efficacious in maintaining and inducing remission~     in human ulcerative colitis (UC), the investigators intend to conduct an open label study~     using Synergy-1, a 1:1 oligosaccharide/ inulin mixture, in patients with mild to moderately~     active left-sided UC. The investigators hypothesize that oligofructose-enriched inulin~     (Synergy-1) can be used safely in the treatment of mild to moderate UC, and daily oral~     administration of Synergy-1 will result in the clinical improvement and/ or remission of~     disease. Subjects will be randomized to either a 7.5g or 15g dose of Synergy-1 in order to~     investigate what amount of the prebiotic is efficacious and tolerable in patients with active~     UC. The clinical activity of disease will be evaluated using endoscopy and symptom scores.~     The investigators will also study the effect Synergy-1 on mucosal histology, intestinal~     microbiota composition and function and markers of inflammation (e.g. fecal calprotectin,~     cytokines). The study will be for 9 weeks from baseline wherein all subjects will receive~     Synergy-1 treatment. Half the subjects will receive a dose of 7.5g and half will receive 15g~     daily.~   "
112589|NCT02093754|"~     This study will allow to assess liver related injuries in HIV patients.~   "
112590|NCT02093741|"~     This is a Post-Authorization Safety Surveillance (PASS) study designed to collect data on the~     safety and effectiveness of ADVATE reconstituted in 2 mL Sterile water for injection (SWFI)~     during routine clinical practice in children until 12 years of age. This surveillance study~     is a post-licensure commitment for ADVATE reconstituted in 2 mL SWFI.~   "
112591|NCT02093728|"~     Study to assess the effect of Itraconazole and Fluconazole on the pharmacokinetics of~     Selumetinib (AZD6244; ARRY-142866) ( Hyd-Sulfate) in Healthy Male Volunteers~   "
112592|NCT02093715|"~     The purpose of this study is to determine Fractional exhaled Nitric-Oxide (FeNO)levels and~     blood cytokines during acute bronchiolitis, and to seek for correlation between these markers~     and future development of asthma.~   "
112593|NCT02093702|"~     The objective of this study is to assess whether a structured exercise program compared to~     routine recommendation for exercise has any positive impact on disease outcome in patients~     with type 2 diabetes.~      This study aims to assess whether a structured exercise program has an impact on the~     following determinants of the disease in type 2 diabetes: HbA1C, blood pressure, lipids, body~     mass index and waist circumference. It also aims to assess the compliance and retention of~     patients with type 2 diabetes in a structured exercise program.~   "
112594|NCT02093689|"~     The purpose of this study is to evaluate the effect of OMS302 on the signs of Intraoperative~     Floppy Iris Syndrome in patients at risk.~   "
112595|NCT02093676|"~     It is presumed that families of poorly controlled diabetic adolescents (type 1) would benefit~     from parents' counselling, guided by the New Authority model.~   "
112596|NCT02093663|"~     To assess clinical response to MMX mesalamine/mesalazine between a low and high dose in~     children and adolescents aged 5-17 years with mild to moderate Ulcerative Colitis (UC) or who~     are in remission.~   "
112597|NCT02093650|"~     Compare the treatment efficacy of black cohosh extract 80 mg daily and placebo for moderate~     to severe menopausal symptoms~   "
112598|NCT02093637|"~     The purpose of this study is to determine if the addition of Battlefield Auricular~     Acupuncture (BFA) to standard therapy causes reduction in pain, medication use, time to~     ambulation without assistance, hours missed from work and increases quality of life after~     lower extremity surgery at two Air Force Medical Centers.~   "
112632|NCT02093169|"~     To investigate the relationship between the combined Lu AF35700 and Lu AF36152 plasma~     concentration and D2 dopamine receptor occupancy up to 172 hours after oral dosing of Lu~     AF35700~   "
112600|NCT02093598|"~     Type of Application: Clinical trial of new indication.~      Experimental drug: The study dose of temsirolimus will be 25 mg administered intravenously,~     infused over a 30- to 60-minute period once weekly for 28 days (Total doses: 4 doses).~     Temsirolimus is a selective inhibitor of mTOR (mammalian target of rapamycin).~     Pharmacotherapeutic group: Protein Kinase Inhibitors; ATC code: L01X E09.~      Primary Objective:~        -  To identify in tumor samples future biomarkers associated with a short term exposure to~          temsirolimus.~        -  This is an exploratory clinical study. No efficacy objectives are included in this~          clinical trial.~      Secondary Objectives:~        -  To estimate the tolerability for all temsirolimus-treated patients throughout the study~          and up to 28 days after the last dose of temsirolimus.~        -  To correlate observed changes with the different type of endometrial carcinoma (type I~          and type II), with regard to proteins related to mTOR (p4EBP1, pS6K1, c-MYC, cyclin D,~          p27, BAD, p53, Bcl-2 PTEN, pAKT, mTOR),~        -  To estimate the potential predictive value of some biomarkers (immunostaining for PTEN,~          pAKT, mTOR), relevant mutations in PTEN, PI3KCA, k-RAS, CTNNB1, and microsatellite~          instability status.~        -  To estimate the prognostic value of Ki67 expression after short-term presurgical therapy~          exposure~        -  To collect data about the differences in expression profile, assessed by RNA microarrays~   "
112601|NCT02093585|"~     Some but not all observational studies have found that current exposure to abacavir is~     associated with increased risk of cardiovascular events such as myocardial infarction, stroke~     and cardiovascular death. This study aim to investigate possible adverse effect of abacavir~     on platelet reactivity, coagulation and endothelial activation in HIV-1 infected patients.~     The study is an open-labeled cross-over trial, where patients receiving antiretroviral~     therapy containing abacavir switch treatment to a regimen containing tenofovir and vice versa~     for a period of 90 days.~   "
112602|NCT02093572|"~     The purpose of this study is to test the hypothesis that the disruption of the normal~     (three meals a day) eating pattern and prolonged overnight fasting caused by skipping~     breakfast: i) alters the expression of specific clock genes and clock gene targets involved~     in regulating adipose tissue lipolysis (breakdown or destruction); ii) increases basal~     adipose tissue lipolytic (breakdown) activity and plasma free fatty acid (FFA)~     concentrations; iii) reduces skeletal muscle insulin sensitivity; and iv) increases daylong~     plasma glucose, FFA, and insulin concentrations. The investigator will do this by studying~     healthy, lean persons either randomized to consume either 3 standard meals per day or omit~     breakfast and consume 2 meals per day without changing daily calorie intake (skipping~     breakfast group).~   "
112603|NCT02093559|"~     REBOOT is a pilot randomized trial of a repeated-dose brief intervention to reduce overdose~     and risk behaviors among naloxone recipients (REBOOT). It includes an established overdose~     education curriculum within an Informational-Motivation-Behavior (IMB) model. This study will~     test the feasibility of an efficacy trial of REBOOT vs treatment as usual (information and~     referrals) that will evaluate overdose events (non-fatal or death), drug use cessation, and~     overdose and HIV risk behaviors, among opioid-dependent persons who have previously overdosed~     and already received take-home naloxone (the opioid antagonist used to reverse overdose).~   "
112604|NCT02093546|"~     The goal of this study is to check the effect of trametinib alone and when given with~     GSK2141795 on biomarkers in patients with persistent or recurrent endometrial cancer.~     Biomarkers are found in the blood/tissue and may be related to your reaction or response to~     the study drug.~   "
112605|NCT02093533|"~     Membranoproliferative glomerulonephritis (MPGN) is the third or fourth leading cause of end~     stage renal disease among the primary glomerulonephritis. Hyperactivation of the alternative~     complement pathway and familial forms for all types of MPGN have been reported suggesting~     that genetic abnormalities may play a predisposing role to the disease. In recent case~     reports Eculizumab, a monoclonal antibody that binds to C5 to prevent formation of the~     membrane attack complex ,is a safe and effective therapy.~   "
112606|NCT02093520|"~     Study Objective: To compare patient outcomes following treatment with either the MILD~     procedure or epidural steroid injections (ESIs) in patients with painful lumbar spinal~     stenosis exhibiting neurogenic claudication and having verified ligamentum flavum hypertrophy~     as a contributing factor.~   "
112607|NCT02093507|"~     The purpose of this study is to determine whether the result of parent's feet manipulation~     compared with nonmanipulated group within first 6 months of life and observe spectrum of the~     disease within this period.~   "
112608|NCT02093494|"~     This is a randomized, open label study to evaluate the Initial Specimen Diversion Device~     (ISDD) in reducing the contamination rate in blood culture analysis. Blood culture data will~     be derived from inpatient and/or outpatient settings in a variety of hospital departments~     (e.g. ER, surgical, medical, etc.). Only samples that are collected via PIVC's may be~     included in this study. The ISDD will be compared to current laboratory practices for the~     collection of blood for culture purposes. Laboratory Standard Procedures (LSP) is defined as~     collection of venipuncture blood for culture without an initial diversion method to divert~     and sequester potential blood contaminants.~   "
112609|NCT02093481|"~     The experimental model is a semi-acute study where the purpose of the study is to evaluate~     food factors related to colonially derived regulation of glucose metabolism (and related~     parameters) and satiety in healthy subjects.~   "
112610|NCT02093468|"~     The purpose of this study is to evaluate the safety and efficacy of MST-188 in subjects~     receiving catheter-directed rt-PA for acute lower limb ischemia and to evaluate whether~     treatment with MST-188 results in more rapid thrombolysis of the occlusion and more rapid~     tissue perfusion in the effected blood vessel.~   "
112611|NCT02093455|"~     This is a randomized, double-blinded trial (Chardonnay seed flour vs. placebo - in pill form)~     with the purpose to test the impact of a four-month supplementation with Chardonnay Seed~     Flour (CSF) on endothelial function. Chardonnay flour is made from wine grape skins and~     seeds. We will examine the effect of CSF on parameters such as endothelial function (via~     EndoPAT testing), plasma lipid levels, glucose tolerance, insulin resistance, inflammatory~     markers, oxidative stress surrogates, endothelial progenitor cells (EPCs) as well as the~     makeup of and impact on the gut microbiome (via stool samples).~   "
112679|NCT02092558|"~     Background: Squamous metaplasia refers to the pathological transformation of the urothelium~     leading to non-keratinised stratified squamous metaplasia (N-KSM).~      Objective: To present the investigators experiences in the diagnosis and treatment of N-KSM~     of the urinary bladder in children.~   "
112614|NCT02093416|"~     Prospective cohort study evaluating the role of leptin receptors in the bariatric surgical~     population compared with non obese controls. Additionally serum levels of leptin, ghrelin,~     motilin and PYY will be compared amongst the different BMI classes and a quality of life~     questionnaire completed by all participants.~      The hypothesis is that obese individuals have lower leptin receptors in enterocytes which is~     partially responsible for the higher serum leptin levels without appropriate control of~     satiety.~   "
112615|NCT02093403|"~     This phase I trial studies the side effects and best dose of Selinexor when given together~     with decitabine in treating patients with acute myeloid leukemia that has returned after~     treatment (relapsed) or does not respond to treatment (refractory). Drugs used in~     chemotherapy, such as decitabine and Selinexor, work in different ways to stop the growth of~     cancer cells, either by killing the cells or by stopping them from dividing.~   "
112616|NCT02093390|"~     This is a nonrandomized, open-label, fixed-sequence, 2-arm study designed to assess the~     effect of multiple doses of fluconazole or atorvastatin on the single-dose pharmacokinetics~     of TAK-385 in healthy adult subjects.~   "
112617|NCT02093377|"~     The aim of this randomized controlled trial is to test the effect of 12 weeks Adaptive~     Servo-Ventilation (ASV) therapy (additionally to optimal medical management of myocardial~     infarction) on myocardial salvage (MSI=myocardial salvage/area at risk, primary endpoint).~   "
112618|NCT02093364|"~     The purpose of this focused registry is to evaluate the clinical implications of the RHP~     position (relative to the articulations) regarding functional and radiographic parameters in~     patients treated with the RHP with a straight and curved stem.~   "
112619|NCT02093351|"~     This is an open-label 2-part Phase I study in patients with advanced solid tumours. Part A of~     the study (mandatory) will assess the effect of olaparib on the pharmacokinetics (PK) of~     anastrozole, letrozole and tamoxifen and vice versa; Part B will allow patients (if eligible)~     continued access to olaparib after the PK phase and will provide additional safety data.~   "
112620|NCT02093338|"~     The main objective of this intervention study is to evaluate the efficacy of Lactobacillus~     fermentum CECT5716 to reduce the presence in the milk of genera Staphylococcus and~     Streptococcus as risk factors for mastitis in women with breast pain~   "
112621|NCT02093325|"~     The purpose of this study is evaluate the efficacy and safety of eltrombopag as a rescue of~     isolated chemotherapy-induced thrombocytopenia in patients with solid tumor .~   "
112622|NCT02093312|"~     The overall objective of the study is to investigate the effect of energy- and protein~     enriched home delivered meals vs. habitual diet in malnourished patients suffering from~     cancer on various endpoints.~   "
112623|NCT02093299|"~     Stroke patients are given prophylactic treatment with clopidogrel to prevent new strokes.~     Some of these patients (the investigators don't know precisely how many, but previous studies~     indicate 4-34%) are so called non-responders, when you measure on a blood sample from the~     patient. These patients may have an increased risk for less effect of the treatment and~     therefore a higher risk for a new stroke.~      The investigators want to investigate if clopidogrel non-responders have a clinically~     increased risk of a new stroke by following the patients for two years. With this study the~     investigators aim to ensure that all patients get the best prophylactic treatment and reduce~     the risk of early death and dependency of others.~   "
112624|NCT02093286|"~     To assess any serious systemic reaction within 30 minutes after Pentabio immunization~   "
112625|NCT02093273|"~     The objective of this study is to compare the antibody response 30 days after two doses of t~     OPV~   "
112626|NCT02093260|"~     To Asses the Immunogenicity and Safety of Flubio (Influenza HA) Vaccine in Infants and~     Children (Bridging Study)~   "
112627|NCT02093247|"~     This study is Observational multi-center, prospective study to characterize novel pathogen-~     and host-related factors in hospitalized patients and patients in the Emergency Department~     (ED) presenting with lower respiratory tract infections (LRTI) and/or sepsis.The Study's~     objective is to develop a novel multi-parametric diagnostic model for the management of~     patients with LRTI and/or sepsis that will be based on novel pathogen- and host-related~     factors.~   "
112628|NCT02093234|"~     This is a randomized controlled trial comparing 3 strategies to improve wellness behaviors~     and clinical goals for diabetes type 2(DM2) Medicaid patients. A patient interactive cell~     phone disease management system plus a community health worker (CHW) is superior to either a~     cell phone system or a CHW alone to activate DM2 Medicaid patients to improve a composite of~     7 Wellness Behaviors and 6 Clinical Goals.~   "
112629|NCT02093221|"~     This is a multicenter, randomized, partial-blinded, five-arm, placebo-controlled study of~     human plasma-derived alpha1-proteinase inhibitor (alpha1-PI) in children (ages 6-11 years~     old) and teens/adults (ages 12-35 years old) with new onset Type 1 Diabetes Mellitus (T1DM).~     Currently enrolling ages 12-35 only. Once 25 patients are randomized and data is reviewed~     enrollment will be opened to the child cohort. The purpose of this study is to evaluate the~     safety and efficacy of four dosing regimens of human plasma-derived alpha1-PI in T1DM.~   "
112630|NCT02093195|"~     Present treatment for chronic obstructive pulmonary disease (COPD) has a certain role in~     reducing COPD exacerbation and hospitalization, improving the life quality, and postponing~     the lung function decline. But for some patients with severe COPD, current treatment only~     partially alleviates the symptoms and has little role in the lung function decline. In this~     randomized, multicenter study, the investigators evaluate the safety and efficacy of bosentan~     in the treatment of grade Ⅲ or Ⅳ COPD patients with pulmonary hypertension detected by~     echocardiography. The primary endpoint is the frequency of COPD exacerbation, and the~     secondary endpoint includes changes of lung function, 6-min-walk distance (6-MWD), SGRQ score~     and mMRC/CAT score.~   "
112631|NCT02093182|"~     The lack of a precise diagnostic technique for cerebral vasospasm associated with traumatic~     brain injury (TBI) limits the ability to detect and treat this phenomenon. Surveillance~     Transcranial Doppler ultrasonography (TCD) is the main medical instrument that is utilized to~     monitor radiographic vasospasm following TBI, yet has its drawbacks such as inaccuracy,~     highly operator dependent and more.~      HS-1000 device, an investigational vasospasm detection device, has the potential to safely~     diagnose and assess vasospasm with minimal discomfort to patients, allowing a new modality~     for vasospasm measurement tool.~      We aim to evaluate the correlation between the collected and analyzed data from the HS-1000~     device and the clinical findings from the TCD tests post-subarachnoid hemorrhage (SAH)~     patients.~   "
112633|NCT02093156|"~     Colonoscopy is the current standard method for evaluating the colorectal diseases. Adequate~     bowel preparation is essential for optimal visualization of the colorectal mucosa. However,~     inadequate bowel preparation (IBP) had been unexpectedly reported in up to 30% of patients~     undergoing colonoscopy. Many factors may influence the quality of bowel preparation, which~     can be broadly categorized as patient-related or procedure-related. It has been shown that~     split-dose regimen or some modified educational strategies can improve the quality of bowel~     preparation. For the patients with possible IBP before the performing of colonoscopy, it may~     be better to repeat bowel preparation with modified or enhanced strategies in case of failed~     intubation, missed lesions or unnecessarily increased cost. Thus, it is important to set up a~     model to predict the quality of bowel preparation individually.~   "
112634|NCT02093143|"~     The most important considerations for the general anesthesia in diagnostic panendoscopy of~     the upper airway is the maintenance of a patient's airway for optimal surgical exposure,~     adequate ventilation and sufficient depth of anesthesia. Tubeless anesthestic techniques with~     preserved spontaneous ventilation and total intravenous administration of anesthetic drugs~     are widely use. Due to its pharmacological profile, propofol anesthesia is often considered~     as the gold standard for the anesthesia in the diagnostic panendoscopy. Previous studies~     suggested that adding remifentanil to propofol could improve the conditions for laryngoscopy~     and tracheal intubation.~      The aim of this study is to assess the impact of propofol remifentanil general anesthesia~     compared to propofol general anesthesia on the conditions of the diagnostic panendoscopy of~     the upper airway.~   "
112635|NCT02093130|"~     This project is designed to study whether pomegranate juice benefits cognitive abilities in~     middle-aged and older non-demented volunteers. Subjects will be randomly assigned to one of~     two treatment groups: either a placebo or the pomegranate juice. Subjects will drink eight~     ounces of the pomegranate juice or placebo daily for twelve months.~      The investigators expect the people receiving the pomegranate juice to show better cognitive~     performance compared with those receiving a placebo after one, six, and twelve months. The~     investigators believe cognitive decline and treatment response will vary according to a~     genetic risk for Alzheimer's.~      The investigators will study 212 non-demented subjects aged 50-75 years. Initially, subjects~     will undergo a clinical assessment, an MRI and a blood draw to determine genetic risk and to~     rule out other neurodegenerative disorders linked to memory complaints.~      Subsequently, subjects will undergo the first memory (or neuropsychological) assessments.~     Following the first assessment, subjects will begin drinking the juice (either the~     pomegranate juice or the placebo). Subjects will undergo a brief memory test at one-month~     mark. At six months, subjects will have a second, full neuropsychological assessment. The~     final assessment will take place at the end of the study, the 12-month mark. Additional blood~     will be drawn at baseline and at 12 months and frozen to assess inflammatory markers if~     outcomes are positive.~      In total, subjects will be expected to come to the University of California, Los Angeles~     (UCLA) for 5 visits during the course of 12-13 months.~   "
112636|NCT02093117|"~     Background. Patients undergoing neurosurgical procedures experience higher rates of~     postoperative respiratory failure compared to the broader surgical population.~     Lung-protective ventilation strategies, including alveolar recruitment maneuvers may be~     beneficial. Despite this potential benefit, the effect of high levels of continuous airway~     pressure on intracranial pressure, brain swelling and cerebral perfusion must be defined~     prior to applying this intervention to the neurosurgical population.~      Objectives. The primary objective is to determine the effect of an alveolar recruitment~     maneuver on subdural pressure in patients undergoing supratentorial tumour resection. The~     secondary objectives are to determine the effect of an alveolar recruitment maneuver on 1)~     brain bulk score and 2) cerebral perfusion pressure in patients undergoing supratentorial~     tumour resection.~      Hypothesis. The investigators hypothesize that an alveolar recruitment maneuver of 30 cm of~     water over 30 seconds will not result in a clinically-important (>3 mmHg) increase in~     subdural pressure.~      Methods. This single center, randomized, cross-over study will enroll 30 American Society of~     Anesthesiologists Classification I-III patients scheduled to undergo supratentorial brain~     tumour resection at Vancouver General Hospital. All patients will receive a standardized~     general anesthetic including invasive blood pressure monitoring. After removal of the bone~     flap, subdural pressure will be measured using a sterile 22-gauge plastic cannula. Brain bulk~     will be assessed using a validated 4-point scale. After baseline arterial and subdural~     pressure determination and brain swelling assessments, patients will be randomized to receive~     either a recruitment maneuver of 30 cm of water for 30 seconds or a sham recruitment maneuver~     of 5 cm of water for 30 seconds. Maximal subdural pressure and minimum mean arterial pressure~     during the maneuver will be noted, and the neurosurgeon will be asked to score the brain~     bulk. After a 2-minute equilibration period, the protocol will be repeated with the alternate~     group allocation.~      Statistical Analysis. Our sample size calculation, based on our primary outcome (subdural~     pressure), determined that a sample size of 22 patients would allow us to detect a difference~     of 3.5 mmHg in subdural pressure assuming a type I error of 0.05, a type II error of 0.2 and~     two-sided significance testing. The subdural pressure during the recruitment maneuver as~     compared to the sham maneuver will be analyzed using a paired t-test. The brain bulk score~     will be compared using a Wilcoxon signed rank test. All data analysis will be performed with~     STATA 12.1 (StataCorp, College Station, TX).~   "
112637|NCT02093104|"~     The purpose of this research study is to evaluate the quantitative information of utilizing~     C-arm systems in liver tumor care in hopes this potential clinical combination of imaging~     could aid in diagnosis and evaluation of tumor therapy.~   "
112638|NCT02093091|"~     This clinical trial was performed to evaluate the nano-filled resin modified glass ionomer~     (RMGI) -with a brand name of Ketac Nano- as a filling material for the treatment of caries~     in primary teeth. Children aged 5-8 years were selected and treated with either Ketac Nano or~     another conventional RMGI called Vitremer. Then, the treated children were evaluated at~     baseline, after one yeat and after two years. The hypothesis to be tested in the present~     study was: The clinical performance of nano-filled RMGI (Ketac Nano) in class I primary~     molars will differ from that of its preceding conventional RMGI (Vitremer).~   "
112639|NCT02093078|"~     Crisis resource management represents the set of non technical skills, such as communication,~     leadership, delegation, and prioritization, that allow effective teamwork for optimal patient~     care during an urgent and critical situation. The Cognitive Aids with Roles Defined (CARD) is~     a new concept of cognitive aid addressing the well-documented issue of teamwork in crisis~     management. It relies on large identification cards specially designed for each team members~     profession and role. During a life threatening clinical situation, the CARD protocol focuses~     on clarification of individual roles and distribution of tasks for crisis management rather~     than creating an additional algorithm identifying either a list of actions to be taken or the~     dose of a medication. This study aims to evaluate the clinical impact of introducing the CARD~     protocol in obstetrical emergency situations (code 333) in clinical practice at The Ottawa~     Hospital.~      Hypothesis: CARD protocol will: (i) decrease the total time taken to deliver the baby, and~     (ii) improve clinical outcome for the mother and baby compared to traditional management~     without the CARD protocol.~   "
112680|NCT02092545|"~     Study to collect data on weight management on a male population of retired NFL athletes.~   "
112640|NCT02093065|"~     Abnormalities in the gene encoding Factor VIII (FVIII) results in hemophilia A, an X-linked~     recessive bleeding disorder with a prevalence of 1 in 5000 males. Hemophilia A patients are~     classified into 3 different categories based on residual FVIII activity compared to normal:~     mild (6-40%), moderate (1-5%) and severe (<1%). This categorization correlates to some degree~     with bleeding phenotype, but does not completely define it. Some patients with hemophilia A~     bleed less often than others despite identical plasma FVIII levels. The cause(s) of this~     phenotype heterogeneity in hemophilia A remains largely unknown, despite a number of studies~     of possible factors.~      Activated platelets, in addition to their role in primary hemostasis, play a major role in~     secondary hemostasis (coagulation) by providing a phospholipid surface to which coagulation~     factors bind. A role for platelets in the hemorrhagic propensity of hemophilia A has been~     suggested in the past, but only a small number of studies have been performed with~     limitations in assays performed and numbers of patients. The purpose of the present study is~     to determine whether platelet reactivity in severe hemophilia A patients is associated with~     past bleeding frequency and/or predicts future bleeding frequency.~   "
112641|NCT02093052|"~     This study will assess early and middle childhood outcomes of an intervention for neglecting~     parents that was implemented in the children's infancy. We expect that parents who received~     the Attachment and Biobehavioral Catch-up Intervention in infancy will be more nurturing and~     will follow children's lead more than parents who received a control intervention, and that~     children will show better outcomes in attachment, inhibitory control, emotion regulation, and~     peer relations than children of parents who received the control intervention.~   "
112642|NCT02093039|"~     The aim of this study is to assess the impact of a decision aid leaflet on the participation~     of women invited to participate in the French national breast cancer screening program.~   "
112643|NCT02093026|"~     This study will assess the long-term safety and efficacy of repeat treatment courses of~     rituximab, in combination with methotrexate in a disease-modifying anti-rheumatic drug~     (DMARD) inadequate responder population of participants who were previously randomized into~     studies WA16291 (NCT02693210) or WA17043/U2644g (NCT00074438). The study permits multiple~     re-treatments until the protocol-defined end-of-treatment date (31 December 2011).~     Participants will then enter a safety follow-up (SFU) period of at least 48 weeks. This will~     provide at least 7 years follow-up data on all participants initially randomized into WA16291~     or WA17043/U2644g. Approximately 600 participants will potentially be eligible to enter this~     open label extension study from their respective feeder studies.~   "
112644|NCT02093013|"~     The investigators propose to implement and evaluate an integrated care program for enhancing~     the care of patients with asthma in a region of Quebec province, Canada. The investigators~     will implement our intervention in a family medicine group practice setting and plan to~     deliver it to 150 experimental group subjects. The investigators will simultaneously study~     300 control subjects who are receiving usual care in other regions of the province of Quebec.~     Our hypothesis is that the program will improve the quality of life of patients with asthma~     exposed to the program, asthma control, inhaled corticosteroid adherence, knowledge of~     asthma, and a number of variables that relate to the conceptual model selected as a framework~     for this study (the PRECEDE-PROCEED model of Green and Kreuter).~   "
112645|NCT02093000|"~     This prospective, open-label, single arm, non-interventional study will investigate the~     effectiveness of bevacizumab monotherapy in participants with lung adenocarcinoma who~     previously received 4 to 6 cycles of induction platinum doublet plus bevacizumab.~   "
112646|NCT02092987|"~     The primary research question is which of the 2 best known dementia caregiver interventions,~     the New York University Caregiver intervention (NYUCI) and Resources for Enhancing Caregivers~     Health (REACH OUT), is more effective in alleviating depressive symptoms and caregiver burden~     among Hispanic caregivers in New York City. The investigators hypothesize that the NYUCI will~     be more effective than REACH OUT in reducing caregiver depressive symptoms and burden among~     Hispanics because of its focus on family-centered counseling, which is posited to be more~     important among Hispanic caregivers because of a cultural emphasis among Hispanics on family~     interactions in interventions. In order to answer the primary question, the investigators~     will conduct a pragmatic randomized trial comparing the NYUCI vs. REACH OUT in 200 Hispanic~     caregivers of persons with dementia in the community of Northern Manhattan. The total time of~     the intervention will be 6 months.~      Our research question is which intervention, NYUCI or REACH OUT, is better in Hispanic~     relative (any relative) caregivers of persons with dementia. Our objective is to obtain~     effectiveness information that will help caregivers and health providers to make decisions~     about which intervention to choose. Our primary aim is to compare the effectiveness of the~     implementation of the NYUCI and REACH OUT in reducing depressive symptoms and burden. Our~     exploratory aims are to examine and compare the predictors of effectiveness of the NYUCI and~     REACH OUT and to examine additional outcomes such as caregiver stress and physical health,~     and outcomes related to the person with dementia. METHODS. We will conduct a pragmatic~     randomized trial of 200 relative caregivers of persons with dementia. Participants will be~     randomized to the NYUCI or REACH OUT. The total duration of the intervention will be 6~     months, with assessments at baseline and follow-up. All interventions and questionnaires will~     be conducted in both English and Spanish. The study duration will be 3 years. The primary~     outcomes will be changes in caregiver depressive symptoms, measured with the Geriatric~     Depression Scale, and in caregiver burden using the Zarit caregiver burden interview.~   "
112647|NCT02092974|"~     The aim of this study is to assess whether the application of a selective serotonin reuptake~     inhibitor (SSRI) enhances and prolongs the learning enhancement achieved by anodal~     transcranial direct current stimulation (atDCS). For this, young and older healthy subjects~     will be tested with a well established learning paradigm. Results of this study may help to~     support the application of atDCS also in patients, e.g. with dementia or mild cognitive~     impairment.~   "
112648|NCT02092961|"~     This is a sub-study of the OSKIRA-4 study, (D4300C0004, NCT01264770) to explore alternative~     and more sensitive modalities for measuring the beneficial effects of syk inhibition with~     fostamatinib in patients with active RA. This MRI sub-study was reported later than the main~     study due to recruitment delays at specialist imaging sites and so is registered and~     presented entirely separately to the main study results.~      This study will investigate the impact of treatment on joint activity and damage by assessing~     synovitis, osteitis, bone erosions and joint space narrowing.~   "
112649|NCT02092948|"~     The purpose of the study is to determine whether positron emission tomography (PET), using~     the new imaging drug [124 I] PSCA-Minibody can be used for imaging prostate, pancreatic or~     bladder cancer that has spread to the bones and soft tissues (e.g., lymph nodes, lungs,~     etc.). The PET imaging drug tested in this study binds to the cell marker called Prostate~     Stem Cell Antigen (PSCA), which is present on certain prostate, pancreatic and bladder~     cancers.~   "
112650|NCT02092935|"~     The purpose of this research study is to evaluate the safety and effectiveness of a new oral~     antibiotic called SMT19969 in treating C. difficile Infection (CDI).~   "
112681|NCT02092532|"~     The purpose of this study is to evaluate the safety and efficacy of intravitreal aflibercept~     injection (IAI) in patients with neovascular polypoidal choroidal vasculopathy.~   "
112651|NCT02092922|"~     The AfFIRM Study is a Phase 2 study during which patients with advanced multiple myeloma will~     receive single-agent investigational study drug filanesib (ARRY-520). Patients will be~     followed to determine the effectiveness of filanesib in treating myeloma. Approximately 160~     patients from North America and Europe will be enrolled in this study.~      Eligible patients will have received at least two prior lines of therapy; have received prior~     bortezomib and lenalidomide; and have disease refractory to carfilzomib and/or pomalidomide.~   "
112652|NCT02092909|"~     Recent reports have identified a specific oncogenic mutation L265P of the MYD88 gene in~     approximately 90% of the patients with Waldenström's macroglobulinemia. MYD88 is a key linker~     protein in the signaling pathway of Toll Like Receptors (TLRs) 7, 8, and 9, and IMO-8400 is~     an oligonucleotide specifically designed to inhibit TLRs 7,8, and 9. The scientific~     hypothesis for use of IMO-8400 to treat patients with Waldenström's macroglobulinemia depends~     on the inhibition of mutant MYD88 signaling in the TLR pathway, thereby interrupting the~     proliferation of cell populations responsible for the propagation of the disease.~   "
112653|NCT02092896|"~     The purpose of this study is to:~      Part 1:~      To investigate how 12 weeks treatment with liraglutide affects glycemic control in poorly~     controlled patients and how the treatment affects gastric emptying rate during hypoglycemia.~      Part 2:~      To investigate how 12 weeks treatment of type 1 diabetic patients with liraglutide affects~     counterregulatory hormones and cognitive performance during hypoglycemia.~   "
112654|NCT02092883|"~     The purpose of this study was to investigate the presence of neuroinflammation in children~     with infantile spasms using 11C-PK11195 positron emission tomography (PK PET) scan, and its~     response to ACTH treatment by repeating the PK PET scan after treatment.~   "
112655|NCT02092870|"~     Our study aims to explore the effects of Adipose Derived Stem Cells (ASCs) on chronic wounds.~   "
112656|NCT02092857|"~     The immune system of newborn infants is immature with low activity of both innate and~     acquired immune reactions. Early nutrition has an impact on early immune responses. Dietary~     fatty acids are one nutritional factor noted to play a role in immune function. The omega-6~     long-chain polyunsaturated fatty acid, ARA (Arachidonic acid) and the omega-3 fatty acid, DHA~     (docosahexaenoic acid) are found naturally in breastmilk and some infant formulas. The~     balance or relative amounts of ARA and DHA have been associated with immune response. Some~     commercial infant formula contains both ARA and DHA. However, the optimal balance of ARA and~     DHA has not been determined with respect to immune function. This study will assess two~     levels of ARA and the impact on immune response in healthy, term infants and whether genes~     that influence essential fatty acid metabolism alter the nutritional requirement of infants.~   "
112657|NCT02092844|"~     The primary aim of the current study is to evaluate the effectiveness of a Cognitive~     Behavioral Therapy intervention in the treatment of menopause-associated insomnia and~     nocturnal hot flashes.~   "
112658|NCT02092831|"~     This Phase 1, open-label, randomized, 4-period crossover study is designed to determine the~     relative bioavailability of GDC-0941 administered as a single dose of the market image~     formulation at 3 different hardnesses (hardness 1, 2, and 3) and as a single dose of the~     Phase 2 formulation to healthy male and female volunteers. Participants will be randomly~     assigned to 4 possible treatment sequences, each comprising 4 periods (1 per formulation),~     and GDC-0941 will be administered based on the assigned sequence. The study is expected to~     last 8 weeks.~   "
112659|NCT02092818|"~     In accordance with the regulatory guidance this registry has been designed to collect~     information about the long-term safety of Adempas in real clinical practice outside the~     regulated environment of a controlled clinical study.~   "
112660|NCT02092805|"~     The purpose of this study is to assess the efficacy of rTMS over primary motor cortex in~     patients suffering from malignant visceral pain. Thirty four patients were included in the~     study. They are divided randomly into 2 groups using closed envelop as real rTMS group and~     sham group. Real rTMS over the hand area of motor cortex (20 Hz, 10 trains with inter train~     interval 30 second with total pulses 2000, intensity 80% of motor threshold) every day for~     ten consecutive days (5 days/week) and the coil elevated and angled away from the head as~     sham stimulation. Patients were evaluated by verbal descriptor scale (VDS), visual analog~     scale (VAS), and Hamilton rating scale for depression (HAM-D) at the baseline, after 1st,~     5th, 10th session, 15 day and 1 month after end of sessions. Serum human dynorphin (Dyn)~     level was measured at baseline, 5th and 10th session.~   "
112661|NCT02092792|"~     This is an open-label, multicenter, Phase I study to evaluate the safety, tolerability, and~     PK of escalating doses of DLYE5953A administered to patients with incurable, locally~     advanced, or metastatic solid malignancy that has progressed on standard therapy. The Phase I~     study consists of two stages: Stage 1 dose-escalation and Stage 2 expansion in selected~     patients. In Stage 1, a 3 + 3 dose-escalation design will be used to examine the safety,~     tolerability, and PK of increasing doses of DLYE5953A. In Stage 2, patients will be enrolled~     to further characterize the safety, tolerability, and PK of the proposed dose and schedule~     for future studies.~   "
112662|NCT02092779|"~     Obesity is a disease not always attributable to nutritional imbalance, frequently associated~     with changes in key hypothalamic-pituitary (HP) axes. The regain of weight loss after~     hypochaloric diets has been ascribed to these HP disregulations. The aim of the study is to~     explore pituitary morphology and its association with pituitary function and metabolic~     phenotype in outpatient obese individuals evaluated in the period 2010-2013 at the Department~     of Experimental Medicine of the University of Rome La Sapienza, with features of HP disease~     in a cross-sectional .~   "
112663|NCT02092766|"~     Delayed anaemia has been reported in European travellers with malaria cured by artesunate.~     Although no deaths related to this delayed anaemia have been reported so far, blood~     transfusion has been necessary in some affected patients. Recent observations suggest that~     this episodes of anaemia also occurs in endemic countries. The aim of this trial is to assess~     the incidence of late onset anaemia after treatment with intravenous artesunate compared to~     intravenous quinine, to identify patients at risk and to clarify the causes of this delayed~     anaemia.~   "
112721|NCT02092012|"~     The aim of this study is to investigate comparison of preemptive analgesic effects of~     dexketoprofen versus dexmedetomidine on the patients that is undergoing abdominal~     hysterectomy.~   "
112664|NCT02092753|"~     The aim of the study is to analyze if a ketogenic diet (KD) compared to either a low~     glycämic and insulinemic (LOGI) diet or to a standard diet (SD) is feasible, safe and~     tolerable and will improve quality of life and physical performance in patients with Breast~     Cancer during the rehabilitation phase.~      It will be an open-label trial of nutritional intervention for 20 weeks spanning three~     phases: 3 weeks of stationary intervention, 16 weeks of outhouse phase and one final week of~     stationary intervention.~   "
112665|NCT02092740|"~     Retrospective analysis of treatment outcome and side effects of testicular cancer patients~     that had been diagnosed at the University Magdeburg from 1960 until 2012.~   "
112666|NCT02092727|"~     The Southeastern Kidney Transplant Coalition is an academic-community collaboration between~     partners in the kidney disease community who share the common goal of eliminating health~     disparities in access to kidney transplantation among African American End Stage Renal~     Disease living in Georgia, North Carolina, and South Carolina. Volunteer members of this~     community-based coalition include patients with kidney disease, dialysis facility staff and~     providers, transplant centers, quality improvement organizations, and patient advocacy~     organizations. The burden of kidney disease is highest in the Southeast, and yet the rate of~     kidney transplantation is the lowest in the nation. Further, the investigators research~     suggests that racial disparities in access to kidney transplantation are concentrated in the~     Southeast, where African Americans are less likely to access each step in the transplant~     process. The long-term goal of the investigators Coalition is to use community- based~     participatory research approaches to develop, test, and disseminate sustainable, community~     interventions improve access to transplant for African American patients with kidney disease.~     The Reducing Disparities in Access to kidNey Transplantation (RaDIANT) community study~     proposes to use community-based participatory research methods to develop a multilevel~     intervention to reduce racial disparities in access to kidney transplantation. The long-term~     impact of this application will be to reduce racial disparities in the kidney disease~     community.~   "
112667|NCT02092714|"~     This pilot research trial studies molecular analysis in tissue samples from patients with~     advanced or metastatic neuroendocrine tumors. Studying samples of tissue from patients with~     neuroendocrine tumors in the lab may help doctors identify mutations to classify disease and~     plan the best treatment.~   "
112668|NCT02092701|"~     Vitamin D has pleiotropic effects. Burn patients are at risk of hypovitaminosis D and may~     experience post-injury osteopenia and sarcopenia. Investigators hypothesized that vitamin D~     supplementation during one year can improve bone and muscle health in post-burn period.~   "
112669|NCT02092688|"~     This is a prospective observational trial that will enroll pregnant women between 24 and 36~     6/7 weeks of gestation that present with signs and symptom of preterm labor with clinically~     intact membranes and cervical dilatation ≤ 3 cm and a control group of pregnant women without~     signs and risks for PTL to assess how the results of the novel kit for the detection of~     PAMG-1 in both patient groups correlate to their time-to-delivery (TTD) and other adverse~     neonatal and pregnancy outcomes.~      Thes study hypothesis contains that the novel diagnostic kit will identify women who are at~     high risk for preterm birth by a high positive predictive value.~   "
112670|NCT02092675|"~     The purpose of this study is to investigate the role of endothelial dysfunction in chronic~     obstructive pulmonary disease.~   "
112671|NCT02092662|"~     The purpose of this study is to evaluate by objective measures the improvement in upper~     extremity functioning, as reflection of motor learning, in stroke patients in the sub acute~     phase. The investigators hypothesize that the improvements in daily functioning are partially~     due to compensation strategies and partially due to motor learning.~   "
112672|NCT02092649|"~     Fatty acids are the main components of the cell membranes. It has been demonstrated that diet~     can alter the characteristics and function of many membranes in the body, which has an effect~     on cardiovascular and metabolic health. Over the last two decades there has been a~     substantial rise in the research of the effects of Omega 3 polyunsaturated fatty acids on~     bodily function. There are two fatty acids that are of particular interest to researchers,~     eicosapentanoic acid (EPA) and docosahexanoic acid (DHA). These fatty acids have unique~     unsaturated structures, and their incorporation into biological membranes seems to generate~     important and positive physiological effects. The body is unable to synthesize these fatty~     acids in high concentrations to elicit significant effects, so they must be obtained through~     diet in food or via supplementation.~      It has been suggested that EPA and DHA supplementation increases resting metabolic rate (RMR)~     in humans, in part by increasing the use of fat as a fuel during rest. There are a limited~     number of studies examining the effects of Omega 3 supplementation on RMR. Some have found an~     increase in RMR while others have found no change. These studies have some limitations, as~     that they have either used a small sample size, a low omega fatty acid dose and/or short~     supplementation periods. Due to the variable results, the investigators will improve the~     reliability of the RMR measurements by making measures on each subject during two consecutive~     days at each time point that it is measured (0, 6 and 12 weeks).~      Therefore, the purpose of this study is to determine the effects of 12 weeks of omega 3~     supplementation (3 g/d) on healthy young adults vs. the supplementation of a placebo. The~     researchers hypothesize that EPA and DHA supplementation will result in an increase in RMR~     and fat oxidation in some subjects and not in others. The duplicate RMR measures will~     determine the prevalence and magnitude of the omega 3 supplementation.~   "
112673|NCT02092636|"~     An imaging method has been developed that uses near infrared light as an adjunct to~     ultrasound for better diagnosis and for monitoring tumor response. This study will use a new,~     non-invasive way to evaluate breast lumps using a low power light source & ultrasound to see~     if breast lumps are benign or cancerous. This study will also evaluate if this new technique~     might be useful in assessing response to chemotherapy.~   "
112674|NCT02092623|"~     Definition: To find out complications, objective and subjective outcomes of patients with~     symptomatic posterior vaginal wall prolapse undergoing posterior mesh operation in nine~     Finnish hospitals during September 2010 and August 2013. The study hypothesis is that~     complications are acceptable and both objective and subjective outcomes are satisfying.~   "
112675|NCT02092610|"~     An international multicentre, open, comparative, parallel group, prospective clinical~     investigation with a single 5 year follow up visit.~   "
112676|NCT02092597|"~     The purpose of this study is to assess the effects of incretin-based antidiabetic therapies~     (DPP-4 inhibitors and GLP-1 agonists) on cardiovascular, gastrointestinal and renal system~     and to detail the mechanisms underlying their action in these systems.~   "
112677|NCT02092584|"~     The aim of this study is the comparison between the effects of supplementation with omega 3~     or placebo for 8 weeks in serum level of IGF-1 and IGFBP-3 and gene expression of IGF-1 in~     patients with cardiovascular disease.~   "
112678|NCT02092571|"~     A study to assess the pharmacokinetics of 2 progesterone vaginal rings in postmenopausal~     women~   "
112682|NCT02092519|"~     Background: EUS-guided fine needle aspiration (EUSFNA) is a well established technique for~     tissue acquisition and diagnosis with excellent safety profile. The overall diagnostic yield~     of EUSFNA exceeds 80%, with higher rates in EUSFNA of lymph nodes, where rates of >90% may be~     expected, as compared to pancreatic masses, where lower diagnostic rates were reported. To~     maximize the diagnostic yield, at least 3 needle passes are required for lymph nodes and at~     least 4 passes for pancreatic masses. Olympus has recently made commercially available a new~     22 gauge FNA needle (EZ Shot 2 with side port) with a side port at the needle tip. The~     theoretical basis for introduction of the side port is to increase the diagnostic yield.~     Preliminary unpublished retrospective data suggested the yield might be raised. However,~     there are no prospective multicenter randomized controlled studies to ascertain the validity~     of the assumption.~      Aim: To determine whether there is a difference in diagnostic yield between EZ-Shot 2 and~     EZ-Shot 2 with side port in patients with pancreatic masses for evaluation.~      Methods: Patients with pancreatic masses referred for EUSFNA will be recruited prospectively~     and randomized to either EZ-Shot 2 or EZ Shot 2 with sideport for the first puncture, and~     then the alternative needle will be used for repeated punctured. The cytological and~     diagnostic yield at first pass for both needles will be compared.~      Clinical significance: This will determine whether the new needle design can further improve~     the diagnostic yield of EUSFNA of pancreatic masses.~   "
112683|NCT02092506|"~     Triple therapy (TT) comprising proton pump inhibitor (PPI), amoxicillin 1g and clarithromycin~     500mg twice daily has long been considered one of the standard treatment for H. pylori~     infection as initial studies demonstrated success rates of > 90% on per protocol analysis~     (PP) and > 80% on intention to treat (ITT) analysis. However increasing bacterial resistance,~     especially to clarithromycin, has been reported and there are concerns that the efficacy of~     TT has decreased. Sequential therapy (ST) is an alternative first line therapy that consists~     of 5 days of treatment with a PPI and amoxicillin followed by 5-day treatment with the PPI~     and clarithromycin and metronidazole. The rationale for this approach is that amoxicillin may~     weaken the bacterial cell wall in the initial phase of treatment, and prevent the development~     of drug efflux channels that inhibit clarithromycin from binding to ribosomes and thus help~     to improve the efficacy of clarithromycin in the second phase of treatment. A recent~     meta-analysis based on mainly European studies showed that the success rate of ST compared to~     TT was 92.8 - 96% vs. 76.2 - 78.8%. Concomitant therapy (CT) is another alternative first~     line treatment that consists of 10 days of PPI, amoxicillin, clarithromycin and~     metronidazole. The rationale for using CT as a first line treatment option is to address the~     possibility of clarithromycin resistance which is increasingly encountered in clinical~     practice. Currently there are no randomized controlled studies that compared TT with ST in~     Singapore, although both regimens are being used in routine clinical practice. The hypothesis~     is that ST is superior to TT as first line treatment for H. pylori infection.~      The study aim to compare 10-day TT versus 10-day ST versus 10-day CT as first line treatment~     for H. pylori infection in Singapore.~   "
112684|NCT02092493|"~     ScopeGuide (Magnetic endoscopic imaging) is a device used during some colonoscopies which~     provides real-time 3D image of the shape and configuration of the colonoscope as it travels~     through the colon. Whilst it is being used in clinical practice in most units in the UK, it~     is not a device which is routinely used on all lists, and most departments do not own enough~     ScopeGuides to have on all lists. Studies have shown it can potentially aid colonoscopy by~     improving completion rates and times as well as patient comfort in selected endoscopists~     (persons who perform the colonoscopy). However data on its benefit have been conflicting.~      Subjective mental workload (the individuals mental resources required as a result of the~     multiple demands placed on him/her from a task)in healthcare employees is known to be~     important for the performance and safety of healthcare delivery. Increased workload during~     task performance may increase fatigue, facilitate errors and lead to overall inferior~     performance.~      In colonoscopy high mental workload could potentially be responsible for longer procedural~     time, lack of trainee learning, inadvertent missing of lesions in the bowel as well as poor~     technique leading to patient discomfort. The effect of the endoscopist mental workload on~     their performance and potential facilitators to reduce mental workload is an area that has~     been neglected in this field.~      This study aims to look at the mental workload of endoscopist during colonoscopy and the~     effect ScopeGuide may have on this workload.~      Hypothesis: The use of ScopeGuide during colonoscopy will reduce the mental workload of the~     endoscopist performing the procedure~   "
112685|NCT02092480|"~     The If I Were Jack feasibility trial will test the acceptability and feasibility of using and~     evaluating a unique and scientifically informed educational resource on the topic of teenage~     men and unintended pregnancy in post-primary schools in Northern Ireland. The study is being~     conducted by a multidisciplinary team at Queen's University Belfast with collaborators and~     will begin in May 2014. It is a phase II feasibility trial with an embedded process~     evaluation, twenty four months in duration. The research will assess the feasibility and~     acceptability of the intervention and trial methods, and provide estimates for a phase III~     cluster randomised trial, including potential effect sizes and recruitment, retention and~     participation rates, so that the feasibility and optimal design of a full-scale trial can be~     ascertained. It will include an analysis of the costs of delivering the intervention and a~     process evaluation using a mixed-methods triangulated design to determine the acceptability~     of the intervention and research measures to participants and to establish fidelity to~     implementation protocol. Additionally, it will assess variation in normal practice of~     Relationship and Sexuality Education in participating schools in relation to teenage~     pregnancy.~   "
112686|NCT02092467|"~     This post-marketing study is designed to compare the safety of tofacitinib versus TNF~     inhibitor with respect to major cardiovascular adverse events and malignancies, excluding~     non-melanoma skin cancers when given to subjects with rheumatoid arthritis. Other safety~     events, including non-melanoma skin cancers, hepatic events, infections, and efficacy~     parameters will be collected and evaluated in the study.~   "
112687|NCT02092454|"~     To assess the clinical safety and efficacy of the Benzocaine relative to placebo in pain~     relief associated with acute otitis media.~   "
112688|NCT02092441|"~     Randomized controlled trial comparing inhalation of isopropyl alcohol vs placebo (normal~     saline) pads to treat nausea in emergency department patients.~   "
112689|NCT02092428|"~     Investigators at the Biomedical Imaging Research Institute (BIRI) at Cedars-Sinai Medical~     Center have developed a Magnetic Resonance Imaging (MRI) method for imaging coronary arteries~     using slow-infusion, contrast-enhanced data acquisition. This method allows faster data~     acquisition and better spatial resolution.~      Specific aims of this study are to:~        1. compare coronary artery imaging with and without contrast media on both healthy subjects~          and patients;~        2. assess the accuracy of coronary MRI in detecting coronary artery disease as compared to~          conventional x-ray angiography~      Researchers hypothesize that contrast-enhanced MRI will improve the delineation of coronary~     arteries over non-contrast-enhanced MRI and that optimized, contrast-enhanced coronary MRI~     technique will accurately detect coronary artery disease (CAD) as compared to conventional~     x-ray angiography.~   "
112690|NCT02092415|"~     The goal of this study is to use contrast enhanced ultrasound to determine the degree to~     which flow is reduced during application of a junctional tourniquet (JT). Contrast enhanced~     ultrasound is performed to quantify thigh and calf perfusion at baseline and during~     application of the JT~   "
112691|NCT02092402|"~     The purpose of this study is to investigate the effect of fecal microbiota transplantation~     (FMT) on the symptoms of irritable bowel syndrome (IBS) patients.~   "
112692|NCT02092389|"~     The objectives of this study are to explore the fecal calprotectin (fC) levels of UC patients~     under adalimumab therapy and the correlation with their general wellbeing (Quality of Life~     [QoL]), workability, and disease activity.~   "
112693|NCT02092376|"~     The aim of the study is to increase vitamin D concentrations or to keep it on high level,~     respectively, by supplementing with vitamin D3 in a different dose regime, and to improve the~     overall health status in bariatric patients. In this project, the vitamin D status, the~     parameters of inflammation, bone turnover, insulin resistance, liver and depression score of~     bariatric patients are expected to improve, due to supplementation of a loading dose compared~     to the standard therapy.~   "
112694|NCT02092363|"~     This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and~     PK of OMP-54F28 when combined with paclitaxel and carboplatin. OMP-54F28 will be administered~     IV on Days 1 of each 21-day cycle. Paclitaxel (175 mg/m2) and carboplatin (AUC = 5 mg/mL •~     min) will be administered IV on Day 1 of each cycle. A total of 6 cycles of paclitaxel and~     carboplatin will be given. Additional cycles may be given as per institutional standard of~     care after discussion with the Medical Monitor. Treatment with OMP-54F28 will continue after~     completion of treatment with paclitaxel and carboplatin. The planned dose levels of OMP-54F28~     are 5 and 10 mg/kg.~   "
112695|NCT02092350|"~     This study will evaluate the safety and efficacy of combination treatment with grazoprevir~     (MK-5172) + elbasvir (MK-8742) for cirrhotic and non-cirrhotic participants with chronic~     Genotype 1 (GT1) hepatitis C virus (HCV) infection and chronic kidney disease (CKD). The~     primary study hypothesis is that the proportion of HCV GT1-infected CKD participants within~     the Immediate Treatment and Intensive Pharmacokinetics (PK) groups achieving a sustained~     viral response 12 weeks after the end of all study treatment (SVR12) will be >45%.~   "
112696|NCT02092337|"~     Computer-assisted speech training is a speech recognition training system developed for~     cochlear implant users. With minimal facilities and skills, cochlear implant users can~     conduct this training at home. The purpose of this study was to apply this system to~     adolescent and young adult hearing aid users with prelingual severe to profound hearing loss.~   "
112697|NCT02092324|"~     This phase II trial studies how well ruxolitinib phosphate works in treating patients with~     chronic neutrophilic leukemia (CNL) or atypical chronic myeloid leukemia (aCML). Ruxolitinib~     phosphate may stop the growth of cancer cells by blocking some of the enzymes needed for~     cells to reproduce. This trial also studies the genetic makeup of patients. Certain genes in~     cancer cells may determine how the cancer grows or spreads and how it may respond to~     different drugs. Studying how the genes associated with CNL and aCML respond to the study~     drug may help doctors learn more about CNL and aCML and improve the treatment for these~     diseases.~   "
112698|NCT02092311|"~     The purpose of this study is to determine the rates of major post-varicocelectomy~     complications (Recurrence, Hydrocele and Testicular Atrophy) in patients operated with a new~     method named Combined Mini-incision Microscopic Varicocelectomy. The study hypothesis is that~     using this method will lead to less major complications of recurrence, hydrocele, and also~     less incidental injuries to the arteries that will result less testicular atrophy~   "
112699|NCT02092298|"~     The goal of this clinical research study is to learn if hyperthermic intraperitoneal~     chemotherapy (HIPEC) will help to control the disease in patients with Stage 4 stomach or~     gastroesophageal cancer. The safety of this treatment will also be studied.~   "
112700|NCT02092285|"~     The primary objective of this study is to evaluate the efficacy of golimumab in maintaining a~     clinical response in participants with moderate-to-severe ulcerative colitis.~   "
112701|NCT02092272|"~     Patients will be randomly assigned to one of two groups using a random number generator.~     Group 1 will be provided with in-office instruction of standard of care eccentric exercises~     for rotator cuff tendinopathy. Group 2 will be provided with in-office instruction as well as~     a instructional exercise video source (DVD) to take home as a reminder on how to perform two~     specific standard of care eccentric exercises for rotator cuff tendinopathy. Each group will~     be given a card to track adherence to the standard of care eccentric exercise routine as~     measured only by the days that they accomplish their exercises. Study exercise diary will be~     collected after 12 weeks of treatment. Eccentric exercises are taught as part of standard of~     care for rotator cuff tendinopathy.~   "
112702|NCT02092259|"~     The ARIES Norovirus Assay is a real-time PCR based qualitative in vitro diagnostic test for~     the direct detection of Norovirus GI/GII RNA from stool specimens obtained from symptomatic~     patients.~      The purpose of this study is to establish the diagnostic accuracy of ARIES Norovirus Assay.~   "
112703|NCT02092246|"~     To determine the accuracy of unguided versus ultrasound (US) guided knee joint injections in~     obese patients with no clinically detectable effusion.~   "
112704|NCT02092233|"~     The ARIES HSV 1&2 Assay is a PCR based test for the direct detection and typing of herpes~     simplex virus (HSV 1 & 2) DNA.~      The objective is to establish the diagnostic accuracy of ARIES HSV-1&2 Assay.~   "
112705|NCT02092220|"~     This study will test the hypothesis that a wearable bionic pancreas system that automatically~     delivers insulin and glucagon can provide superior regulation of glycemia versus usual care~     for adults with type 1 diabetes.~      Please note that all participants must work or attend school at one of the following~     campuses: Massachusetts General Hospital in Boston, MA; University of Massachusetts Medical~     Center in Worcester, MA; University of North Carolina in Chapel Hill, NC; Stanford University~     in Palo Alto, CA.~   "
112706|NCT02092207|"~     This is a controlled study to determine the effectiveness and safety of KL7016 in the~     treatment of adult patients with dry eye syndrome (DES).~   "
112707|NCT02092194|"~     Online hemodiafiltration (HDF) may improve clinical outcome in end-stage renal disease. The~     supported mechanism is the improved clearance of uremic toxins by convective transporter.~     However, It has not been elucidated which convection volume is optimal, especially in Asia. A~     total of 60 participants receiving conventional hemodialysis will be randomly assigned to~     receive either high dose convective volume (33-43 L/treatment) post-dilution online HDF or~     standard dose (16.8-21.5 L/treatment) for 24 weeks. The primary outcome is the change of~     serum β2 microglobulin levels between baseline and after 24 weeks. The secondary outcomes~     will include changes in the nutritional markers, inflammatory markers, and blood pressure~     from baseline to after treatment.~      This would be the first multicenter prospective, randomized controlled trial to determine~     whether large convective volume improves the treatment efficacy in Korean patients undergoing~     post-dilution online HDF.~   "
112708|NCT02092181|"~     The purpose of this study is to see if the study drug, Mirabegron, is safe and effective in~     treating symptoms of Overactive Bladder in people with Parkinson's Disease.~   "
112709|NCT02092168|"~     The purpose of this study is to determine the effects of age on the pharmacokinetic (PK)~     profile of BIA 9-1067 and its metabolites.~   "
112710|NCT02092155|"~     Some patients that have a tunneled pleural catheter will not have the pleural fluid (water~     around the lung) return after some time (pleurodesis). The purpose of this study is to~     understand how the investigators can predict who will achieve pleurodesis and how this occurs~     by studying the pleural effusion.~   "
112711|NCT02092142|"~     The purpose of this study is to evaluate the safety of Q Fever Vaccine, Phase I, Inactivated,~     Dried, NDBR 105 and collect data on incidence of occupational Q fever infection in vaccinated~     personnel.~   "
112712|NCT02092129|"~     Acromegaly is frequently associated with impaired glucose tolerance and diabetes. We~     hypothesise that pituitary histopathology and plasma hyperprolactinaemia could have~     prognostic value in predicting the risk of glucose metabolic disturbances in acromegalic~     patients. The aim of this study is to examine glucose metabolic outcome in acromegalic~     patients with and without histologically verified prolactin and growth hormone (GH)~     co-secreting adenomas. The study population include 79 patients who have all undergone~     surgical treatment for acromegaly.~   "
112713|NCT02092116|"~     The REDUC trial's objective is to address one of the core issues with the treatment of HIV,~     which is that some HIV infected cells hide in so-called latent reservoirs. The reservoirs are~     unaffected by conventional HIV medication and invisible to the immune system. HDACi have the~     potential to activate these latently infected cells. This will make the HIV infected cells~     visible to the immune system; the immune response generate by Vacc-4x will be able to attack~     and eliminate the infected cells.~   "
112714|NCT02092103|"~     This is a randomized controlled trial that will compare the effects of delayed umbilical cord~     clamping to umbilical cord milking in preterm infants (less than 34 weeks gestation). The~     infants' hemoglobin and hematocrit levels in the Neonatal Intensive Care Unit (NICU) will be~     evaluated, as well as the rates of necrotizing enterocolitis, intraventricular hemorrhage,~     and blood transfusions. The hypothesis is that milking the umbilical cord prior to clamping~     is superior to simply delayed cord clamping, presumably providing an increased blood volume~     to the preterm neonate improving its outcomes.~   "
112715|NCT02092090|"~     The study is a large scale cluster randomised trial to evaluate the effects of sodium~     reduction based upon the use of salt substitute on the risk of stroke defined as the~     occurrence of stroke and stroke deaths. The corresponding null hypothesis that will be tested~     is that sodium reduction will have no effect upon stroke risk. The secondary objectives are~     to determine effects of sodium reduction on major vascular events and total mortality.~   "
112716|NCT02092077|"~     The purpose of this study is to support selection of an appropriate safe and efficacious dose~     for study in further development.~   "
112717|NCT02092064|"~     to investigate the effect of basal proteinuria on pregnancy outcomes of patients with~     Familial Mediterranean fever (FMF).~   "
112718|NCT02092051|"~     Breif summary~      A keystone in preventing diabetic complications in patients with type 1 diabetes is good~     glycaemic control. Frequent self-measurements of blood glucose (SMBG) levels has been an~     essential part of insulin dosing before meals. However, in recent years continuous glucose~     monitoring (CGM) has become a treatment option for notifying the patient on trends in glucose~     levels and warning when these are estimated to be too high and too low.~      In some countries today, Sweden among others, CGM is reimbursed in combination with~     continuous subcutaneous insulin infusions (CSII) in patients with very poor glycaemic control~     or a history of repeated severe hypoglycaemia in adult type 1 diabetic patients. This is~     based on existing clinical trials showing a beneficial effect on HbA1c by combining CGM with~     CSII. However, the majority of adult type 1 diabetic patients are treated with multiple daily~     insulin injections (MDI). Clinical trial data are sparse on the effect of CGM in adult type 1~     diabetic patients treated with MDI, and there are no clinical trial data including only~     patients on MDI.~      The aim of the current study is to evaluate effectiveness, safety and treatment satisfaction~     among adult type 1 diabetic patients on CGM treated with MDI. The design is a 69-week,~     cross-over clinical trial, including 26 weeks treatment with CGM, 26 weeks treatment with~     conventional SMBG and a wash-out period of 17 weeks. In total 120 patients will be included~     at 8 sites in Sweden. The study will have 80% power to detect a 3 mmol/mol (0.3 percentage~     unit) change in HbA1c resulting from CGM.~   "
112719|NCT02092038|"~     Trial to determine the safety of neoadjuvant treatment with concurrent temozolomide and~     radiation therapy, followed by surgery and then further temozolomide.~   "
112720|NCT02092025|"~     The purpose of this study is to evaluate the safety and efficacy of long-term use of~     azilsartan tablets (Azilva Tablets) in patients with hypertension in a routine clinical~     setting.~   "
112724|NCT02091973|"~     The calcineurin inhibitor drugs including cyclosporin and tacrolimus are well-known as~     nephrotoxicity. However, these drugs are essential for kidney transplant especially in high~     immunological risks. To date, however, there is an alternative regimen by using of~     everolimus-based which showing less toxicity than tacrolimus-based regimen by its mechanisms.~     Of note, this study aims to evaluate the toxicity by using microRNA profiles detection~     between everolimus-based and tacrolimus-based immunosuppressive regimen in kidney~     transplantation.~   "
112725|NCT02091960|"~     The purpose of this study is to evaluate the efficacy of enzalutamide with trastuzumab in~     patients with HER2+ AR+ metastatic or locally advanced breast cancer.~   "
112726|NCT02091947|"~     Functional Magnetic Stimulation (FMS) appears to modulate autonomic and somatic nervous~     systems that innervate the lower urinary tract. Stimulation of the pudendal afferent nerve~     near the third sacral root induces relaxation of the detrusor muscles and reinforcement of~     urethral sphincter. Some preliminary studies had indicated the positive effect of FMS on~     stress urinary incontinence. Investigators aimed to evaluate the immediate and long-term~     effect of this method on stress urinary incontinent patients.~   "
112727|NCT02091934|"~     The purpose of the study is to compare the results of PRKK surgery when using~     wavefront-guided excimer laser treatment compared to wavefront optimized excimer laser~     treatment in patients with nearsightedness with and without astigmatism~   "
112728|NCT02091921|"~     Critical Limb Ischemia (CLI) is defined as limb pain that occurs at rest, or impending limb~     loss that is caused by severe compromise of blood flow to the affected extremity. CLI is a~     major cause of death and disability (secondary to myocardial infarction, stroke and~     amputation). The mortality in patients with CLI approaches 13-25% and 50% at one and five~     years respectively. High on-treatment platelet reactivity (HPR) in patients treated with~     aspirin and clopidogrel is associated with increased risk of recurrent cardiovascular events~     after percutaneous coronary interventions and coronary syndromes. Preliminary studies suggest~     that the prevalence of HPR in patients with critical limb ischemia treated with aspirin and~     clopidogrel is as high a 78.5%. In patients with coronary artery disease ticagrelor overcomes~     non-responsiveness to clopidogrel. However, the antiplatelet effect of ticagrelor in patients~     with critical limb ischemia is unknown.~   "
112729|NCT02091908|"~     Evaluate the safety, immune response and reactogenicity of aH5N1 vaccination in adult (18~     through 60 years of age) and elderly (≥61 years of age) subjects with and without underlying~     medical conditions.~   "
112730|NCT02091895|"~     The aims of this research are to validate and develop of therapeutic strategies for patients~     with colorectal lesions in real time through pCLE(probe-based confocal laser endomicroscopy).~     Endomicroscopy is a technique for obtaining histology-like images from inside the human body~     in real-time. Total objections are 311 patients.~      Specific research topics are as below.~        1. Diagnosis and classification of colon polyps through pCLE~        2. Evaluation of the depth of invasion of colorectal cancer or lateral growth type tumor~          through the pCLE~        3. Differential diagnosis of colorectal submucosal tumor through the pCLE~        4. Differential diagnosis of ileocecal ulcers through the pCLE~      The study will be conducted to measure sensitivity, specificity, accuracy, amphoteric predict~     of pCLE diagnosis, and calculate the agreement of prediction compared to the pathological~     findings of lesions Check diagnostic agreement of technical phrases which are derived, the~     matching degree between observers, and will develope a new classification method based on~     this.~   "
112731|NCT02091882|"~     The purpose of this study is to determine the accuracy of IEM detection by the MIND1 System~     by completing a series of Patch applications and IEM ingestions in the clinic.~   "
112732|NCT02091869|"~     The purpose of this study is to see if using a mobile phone application asthma action plan~     will help improve asthma management.~   "
112733|NCT02091856|"~     Project aim: To compare the effectiveness and acceptability of a conventional and a religious~     internet-supported cognitive behavior therapy (iCBT) for depression in Romania.~   "
112734|NCT02091843|"~     Posttraumatic stress disorder (PTSD) affects approximately 30 % of American veterans~     returning from Iraq and Afghanistan. Although the current therapy is effective, a percentage~     of patients will fail to improve and will develop chronic treatment-resistant PTSD. Patients~     suffering from PTSD experience intense suffering, lack of productivity and a higher risk of~     suicide. Unfortunately, combat PTSD has a tendency to be resistant to current treatments.~      The central goal of this project is to develop a new therapeutic strategy involving the~     placement of intracranial electrodes to treat the symptoms of PTSD. The project is based on~     recent evidence showing abnormal activity in a specific brain region of PTSD patients,~     thought to be responsible for the core symptoms of PTSD.~   "
112735|NCT02091830|"~     The purpose of this study is to assess whether radiographic osteoarthritis severity (OA;~     Kellgren-Lawrence scale) is associated with self-reported improvement in pain after~     non-surgical treatments (physiotherapy, pain killers, injection, other treatments).~      The hypothesis is that radiographic OA severity is inversely associated with self-reported~     improvement.~   "
112736|NCT02091817|"~     The purpose of this study is to determine whether oxytocin affect face perception~   "
112737|NCT02091804|"~     The purpose of this study is to to conduct a randomized controlled trial comparing an~     intervention group and a control/wait list group to evaluate the feasibility of the Promoting~     First Relationships method in an American Indian community through their tribal Maternal and~     Child Health program, and to assess the efficacy of the method in this community.~   "
112738|NCT02091791|"~     The aim of this study is to compare two levels (high and low forces) of short term lumbar~     traction on pain and functional tests of the lower limbs in a specific population of patients~     presenting with acute lumbar sciatica secondary to disc herniation. The investigators~     hypothesize that, in this particular medical condition, high level of lumbar traction might~     be more effective than low level lumbar traction in decreasing the pain associated with acute~     sciatica.~   "
112739|NCT02091778|"~     The primary objective of this post market clinical follow-up (PMCF) investigation is to~     evaluate performance and safety of fast gelling dressing when used as intended in Diabetic~     Foot Ulcer (DFU).~      The primary endpoint will be Changes from baseline in the condition of the peri-wound skin~     measured by the following variables; maceration, redness/irritation, rash/eczema, blistering,~     dermatitis, skin stripping, trauma to wound edges and product degradation on the skin~   "
112744|NCT02091713|"~     Emerging evidences indicate that performance on a variety of functional movement screens can~     identify athletes/soldiers at risk for injury. These field expedient tests have not been~     validated in a military setting or across different military occupational specialties. In~     this prospective study the investigators plan to screen 300 combatants for a 1-year time~     frame in order to validate the suggested algorithm of a list of modifiable and non-modifiable~     risk factors which are hypothesized to predict injury risk during the military service.~   "
112745|NCT02091700|"~     To develop a database of the peripheral choroidal circulation using ultra widefield (UWF)~     imaging. This database will serve as a quantitative reference tool for the comparison of~     subjects to a database of known normal subjects.~   "
112746|NCT02091687|"~     Track behavioral and qualitative longitudinal outcomes in children with hemiparesis who~     previously participated in a randomized, controlled trial (RCT) of intensive therapy combined~     with repetitive Transcranial Magnetic Stimulation (rTMS)~   "
112747|NCT02091674|"~     To determine the efficacy and safety of hyaluronic acid (AdantTM, Tedec-Meiji Farma SA) for~     acute ankle sprain, a single-site, open-label, controlled trial will be conducted.~      The study will be conducted in a sport-medicine clinical research center in London, Ontario,~     Canada. The eligible patients will be 18 years of age and older, have first or second degree~     lateral sprain within 48h of the start of the treatment, and moderate or severe pain (>45mm~     on 100 mm pain visual analogue scale /VAS). Exclusion criteria will include bilateral ankle~     sprain, ipsilateral knee trauma, prior sprain in the past 6 months, use of NSAID prior to~     entry, intra-articular ankle injection in the prior 6 months.~      The patients will receive standard care (RICE and rescue analgesics), and a single 2.5cc~     Adant periarticular ankle injection following provision of informed consent and collection of~     baseline data. NSAIDs, corticosteroids or topical analgesics will not be allowed.~      Assessments will be done at baseline, days 8, 30 and day 90. Efficacy measures will include~     patient's pain VAS on weight bearing (0-100mm) and walking 20m (0-100mm), patients' global~     assessment of ankle injury (5 point categorical scale), patients' assessment of normal~     function/activity (5 point categorical scale), physician's global assessment of ankle injury~     (5 point categorical scale), patients/physician satisfaction assessment (10 point categorical~     scale), time to return to pain-free and disability-free sport and adverse events as per WHO~     definition.~      It is expected that the Hyaluronic acid injections will decrease pain and swelling, promote~     healing, improve time to return to sport and increase mobility.~   "
112748|NCT02091661|"~     The purpose of this study is to evaluate the effectiveness of the two most established~     primary treatments for patients with clinically localized prostate cancer: radical retropubic~     prostatectomy, and external-beam radiotherapy. The primary aim is assessing biochemical~     disease-free survival, overall survival, and prostate cancer-specific survival. As secondary~     objectives quality of Life impact of treatments' side effects will be also assessed.~   "
112749|NCT02091648|"~     The purpose of the proposed study is to conduct a randomized controlled pilot trial of a~     school-based stress management and coping skills training program among a sample of~     economically disadvantaged urban 8- to 12-year-old school children with physician-confirmed~     asthma. The investigators aim (1) to establish feasibility of this approach by recruiting~     from different schools and (2) to learn whether individuals assigned to receive the~     intervention show improvements in psychological function, decreases in lung inflammation, and~     related improvements in asthma health when compared with disease severity-matched peers who~     receive education-only or standard care.~   "
112750|NCT02091635|"~     Functional dyspepsia (FD) is a disorder characterized by chronic or recurrent upper abdominal~     pain or discomfort in the absence of a specific structural cause. Improving gastric~     accommodation and prokinetic effect seem to be an attractive physiological target in patients~     with FD. Motilitone (Dong-A ST, Yongin, Korea) is a new herbal drug that was launched in~     December 2011 in Korea for treating patients with FD. The current study aims to evaluate~     effects of motilitone on gastric accommodation and emptying after a meal in a group of~     healthy volunteers using three-dimensional gastric volume measurements by magnetic resonance~     imaging (MRI). Healthy volunteers are randomly allocated to receive either motilitone or~     placebo in a double blinded manner. After 5 days of treatment, subjects undergo gastric MRI.~     The primary endpoint is gastric accommodation.~   "
112751|NCT02091622|"~     Introduction: Honest prognostication and information for patients are important parts of~     end-of-life care. This study examined whether an educational intervention could increase the~     proportion of patients who received information about the transition to end-of-life care~     (ITEOL).~      Method: Two municipalities (in charge of nursing homes) and two hospitals were randomized to~     receive an interactive half-day course about ITEOL for physicians and nurses. The proportion~     of patients who received ITEOL was measured with data from the Swedish Register of Palliative~     Care (SRPC). Patients were only included if they died an expected death and maintained their~     ability to express their will until days or hours before their death. Four hospitals and four~     municipalities were assigned controls, matched by hospital size, population, and proportion~     of patients receiving ITEOL at baseline.~   "
112752|NCT02091609|"~     This aim of this study is to compare different oral hygiene aids for the ability to remove~     plaque in patients who went through dental implant treatment and are currently on a~     maintenance program at the Graduate Periodontal Clinic, at the University of Manitoba,~     Faculty of Dentistry.~   "
112753|NCT02091596|"~     This will be a randomized, double-blind (evaluator-blind), vehicle-controlled study of 50~     enrolled subjects. Adult subjects (greater than 18 years old) who present with a mildly~     infected diabetic foot ulcer (IDSA criteria) having full thickness (i.e., through the dermis~     but not involving joint capsule, tendon, and bone). Subjects must also provide informed~     consent and meet all other entry criteria to be enrolled and randomly assigned to receive~     PluroGel N or PluroGel vehicle.~   "
112754|NCT02091583|"~     The purpose of this study is to examine the effects of consumption of a novel food supplement~     consisting of Canola Oil, Fibre and DHA, containing the most effective food bioactives,~     including n-3 fatty acid enriched dietary oil high in monounsaturated fatty acids (MUFAs) and~     soluble dietary fibre, aiming at the management of heart disease risk factors in people with~     metabolic syndrome and to test its efficacy and safety in humans.~   "
112755|NCT02091570|"~     This study investigates nutrition bar consumption and possible impact on self-reported~     ratings of hunger and fullness compared to a control.~   "
112757|NCT02091544|"~     Children and adolescents with overweight and obesity are predisposed to significant health~     problems. It is known that childhood obesity can adversely affect almost every organ system,~     and if left untreated, the major impact of childhood overweight is likely to be felt in the~     next generation of adults.~      The aim of  Kijk op overgewicht bij kinderen is to collect and follow-up longitudinal data~     from a population of different degrees of children with overweight regarding etiological~     factors, risk factors and early stages of chronic disease in different degrees of childhood~     overweight.~   "
112758|NCT02091531|"~     This is a phase II study which will test the study drug MLN0128 in patients with castration~     resistant prostate cancer who have received chemotherapy in the past. Phase II clinical~     trials test how well an investigational drug works in treating a specific cancer.~     Investigational means that the drug is still being studied and that research doctors are~     trying to find out more about it. MLN0128 is not approved by the FDA.~      The purpose of this study is to see what effects (good and bad) the study drug MLN0128 has on~     the patient and the cancer. MLN0128 is a drug that belongs to a class of drugs called mTOR~     kinase inhibitors. A protein, called mTOR inside the cells in the body, plays a role in~     controlling how cells grow. In some cancer cells, mTOR may be over-active. This over-activity~     may cause some cancer cells to grow out of control. Research has shown that mTOR inhibitors~     can block this overactivity and may help stop or slow down the growth of some types of cancer~     cells.~   "
112759|NCT02091518|"~     Magnetic resonance imaging (MRI) is a diagnostic imaging method with constant progress and~     improvement in the way the MRI images are obtained. Many of these advances involve changes to~     MRI software and hardware. The goal of this study is to find out the possible benefits of new~     MRI techniques. This will allow us to use the new MRI methods in research and patient care.~   "
112760|NCT02091505|"~     Recent studies have shown that intravitreal injection of anti-VEGF agent, Lucentis~     (Ranibizumab) is effective for macular edema associated with central retinal vein occlusion~     (CRVO). However, there is little information on whether there are any predictive factors of~     treatment outcome after this treatment. We plan to perform comprehensive functional and~     imaging tests to determine significant predictive factors.~   "
112761|NCT02091492|"~     This study will test the hypothesis that daily subcuaneous administration of 20µg of~     teriparatide (TPTD) as compared to daily subcuaneous placebo for twelve weeks accelerates~     proximal 2-segment humerus fracture healing and improves the three dimensional structural~     properties of bone as measured via quantitative bone image analysis and finite element~     modeling assessed by quantitative computed tomography.~   "
112762|NCT02091479|"~     In patients with a high thromboembolic risk, withdrawing anticoagulant treatment is~     recommended in some situations, including when major hæmorrhage occurs. But withdrawing~     treatment can be risky. In patients on a curative dose of anticoagulant medicine, treatment~     withdrawal heightens the risk of thromboembolic events occurring, with potentially major~     consequences. For instance, mechanical valve thrombosis is fatal in 15% of patients.~     Resumption of anticoagulation is therefore critical in patients at high risk for~     thromboembolic events.~      However, in these patients having presented major hæmorrhage, resumption of anticoagulation~     heightens the risk of hæmorrhage recurrence. This risk is even higher when the original~     hæmorrhage was not accessible via surgical, endoscopic or endoluminal hemostasis.~      As far as investigators know, there is no data in the literature to rely on when the major~     hæmorrhage is not accessible via hemostatic intervention and the risk of thrombosis is high.~     When confronted with patients who need anticoagulation but have a high risk of hæmorrhage~     recurrence, the question of when treatment should be resumed has not been resolved. This is~     why investigators propose to conduct a randomised comparative study to evaluate two treatment~     strategies - early resumption (H48 to H72) versus late resumption (H120 to H144) of~     anticoagulation.~      MAIN OBJECTIVE: The main objective of the present study is to evaluate in terms of bleeding~     risk, thrombosis risk and mortality at one month, the effect of early vs. late resumption of~     anticoagulation in patients having presented with serious hæmorrhage while on curative-dose~     anticoagulants and facing a high thromboembolic risk.~   "
112763|NCT02091466|"~     Background: Hypothermia is common during general and regional anesthesia even when active~     warming measures are taken. The existing literature shows that, in pregnant patients, the use~     of forced air-warming during cesarean section under spinal anesthesia does not prevent~     maternal hypothermia. Therefore, this study aimed to establish the efficacy of a pre-warming~     system, initiated 30 minutes before the onset of spinal anesthesia and during surgery, in~     pregnant women subjected to elective cesarean delivery.~      Methods: Forty healthy pregnant patients undergoing elective cesarean section with spinal~     anesthesia were allocated to the control group (Gcont, n = 20), without the use of a thermal~     gown, and to the gown group (Ggown, n = 20), with the use of a thermal gown in the~     preoperative care unit, 30 minutes before spinal anesthesia installation and during surgery.~     After the anesthesia, the thermal gown was moved from the regular position and placed over~     the chest and upper limbs, as an upper body blanket, and maintained throughout the study. The~     following variables were observed: preoperative and operative room temperature, hemoglobin~     saturation, heart rate, arterial pressure, tympanic temperature in the preoperative care unit~     room (baseline) and at 0, 15, 30, 45 and 60 minutes after spinal anesthesia. Repeated Measure~     ANCOVA compared temperatures of each group, adjusted for baseline values.~   "
112775|NCT02091310|"~     In accordance with International Conference on Harmonisation (ICH) E14 guidelines, this Phase~     I thorough QT (TQT) study will assess the arrhythmogenic potential of GFT505, by evaluating~     its effect on QT/QTc prolongation in healthy male and female subjects. According to the~     guidelines, such studies should typically be performed at the expected therapeutic dose and a~     supra-therapeutic dose that is 3-4-fold higher than the therapeutic dose.~      GFT505 has previously been tested at 240 mg/d in 14-day multiple administration to healthy~     overweight subjects (study GFT505-111-7), and both safety and tolerability were very good.~     However, this dose corresponds to only 2-fold the expected therapeutic dose of 120 mg/d.~     Therefore, the current TQT study will be preceded by a multiple ascending dose study in which~     the safety and tolerability of 2 dose levels of GFT505 (300 and 360 mg) corresponding to 2.5~     and 3 times the expected therapeutic dose will be evaluated. The highest dose level for which~     safety and tolerability are considered satisfactory will be the supra-therapeutic dose used~     in the TQT study.~   "
112764|NCT02091453|"~     Background: To study intensive targeted cognitive rehabilitation of attention in the acute~     (<4 months) and subacute rehabilitation phases (4 -12 months) after acquired brain injury and~     to evaluate the effects on function, activity and participation (return to work).~      Design: prospective, randomised, controlled study. Methods: 120 consecutive patients with~     stroke or traumatic brain injury are randomised to 20 hours of intensive attention training~     by Attention Process Training or by standard, activity based training. Progress is evaluated~     by Statistical Process Control and by pre and post measurement of functional and activity~     levels. Return to work is also evaluated in the post-acute phase. Primary endpoints are the~     changes in the attention measure, Paced Auditory Serial Addition Test and changes in work~     ability. Secondary endpoints include measurement of cognitive functions, activity and work~     return. There are 3, 6 and 12-month follow ups focussing on health economics.~      Discussion: The study will provide information on rehabilitation of attention in the early~     phases after acquired brain injury (ABI); effects on function, activity and return to work.~     Further, the application of Statistical Process Control might enable closer investigation of~     the cognitive changes after acquired brain injury and demonstrate the usefulness of process~     measures in rehabilitation.~   "
112765|NCT02091440|"~     The purpose of the study is to evaluate the safety and effectiveness of the HW005 System in~     patients listed for cardiac transplantation with refractory, advanced heart failure at risk~     of death.~   "
112766|NCT02091427|"~     Acute myocardial infarction (AMI) is defined by an increase and/or decrease in the~     concentration of cardiac troponin, with at least one value above the 99th percentile value of~     the reference population together with evidence of ischemia. An objective tool to determine~     the magnitude of the cardiac troponin change is the use of reference change values (RCV). The~     basis for this tool is that, for a change to be significant, the difference in serial results~     must be greater than the inherent variation in two test results. The inherent variation of a~     laboratory test result is composed of analytical and within-subject biological variation. An~     important requirement to use RCVs is that the concentrations of cardiac troponins fluctuate~     randomly around a homeostatic set point in cardio-healthy individuals. Verification of this~     important condition has never been performed, and violation of this condition would preclude~     the use of RCV's in clinical practice.~   "
112767|NCT02091414|"~     This study will investigate the efficacy and safety of CellCept (1.5-2g/day po), in~     combination with a standard care regimen of cyclosporine A (trough level 150-200ng/mL) and~     steroids, in patients receiving a heart transplant. The anticipated time on study treatment~     is 24 weeks.~   "
112768|NCT02091401|"~     The trial will test the equivalence of a repeat bolus protocol of magnesium sulfate~     administered by the Springfusor® controlled pump to a continuous intravenous regimen. The~     goal of this pharmacokinetic study is to assess the pharmacological equivalence of the serum~     magnesium sulfate concentrations obtained in the treatment of severe preeclampsia with the~     continuous intravenous and Springfusor repeat bolus regimens. The study will also document~     the clinical outcomes, efficacy and acceptability of each treatment for patients and staff.~   "
112769|NCT02091388|"~     This study is to assess the bioavailability of LY03004 compared to Risperdal Consta as well~     as the evaluate the safety and tolerability and preliminary efficacy of LY03004 with repeat~     injections~   "
112770|NCT02091375|"~     To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children~     and young adults with Dravet syndrome.~   "
112771|NCT02091362|"~     The main purpose of the trial is to determine the effect of a study drug known as LY2409021~     on blood pressure and pulse rate in participants with type 2 diabetes mellitus (T2DM) when~     compared to placebo. The study has two periods. Each participant will receive LY2409021 or~     placebo in each period. At least 4 weeks will pass between periods. The study will last about~     23 weeks for each participant. Participants may remain on stable dose metformin, as~     prescribed by their personal physician.~   "
112772|NCT02091349|"~     The objective of this study is to determine the tolerance and utilization of polydextrose and~     soluble corn fiber through analyses of fecal samples of fermentative end-products~     (short-chain fatty acids, ammonia, phenol, and indole) and shifts in microbial populations.~   "
112773|NCT02091336|"~     The aim of this study is to determine the efficacy of oral treatment with glyburide and~     metformin controlling excessive fetal growth in women with gestational diabetes, using~     insulin as a ransom on no response to oral treatment .~      It is randomized with women who seek care at the Outpatient Diabetes in Pregnancy in our~     hospital trial Eligible women between 18 - 45anos diagnosed with gestational diabetes ,~     according to the WHO criteria , ratified the public network for prenatal care at the Clinic~     for Diabetes and Pregnancy HCPA .~      Women with singleton pregnancy and gestational age not exceeding 30 weeks at the time of~     enrollment.~      Pregnant women with indication for pharmacological treatment will be invited to randomization~     to use of oral , glyburide or metformin antidiabetic .~      At regular intervals of 2 - 3 weeks fetal growth will be measured with obstetric~     ultrasonography , until birth.~      The primary outcomes will be :~      ( 1 ) weight and gestational age at birth and the index of large for gestational age fetuses~     ( ≥ 90th percentile for gestational age ) ( 2 ) the use of insulin to achieve glycemic~     targets according to fetal growth , as an indirect measure of the inefficiency of oral~     medications .~   "
112774|NCT02091323|"~     The effect of roux-en-Y gastric bypass(RYGB) on patients with type 2 diabetes mellitus(T2DM)~     and a body mass index(BMI)>35kg/m2 is clear. There are large-scale patients with T2DM in~     Chinese population and currently about two-thirds of them are lack of adequate blood glucose~     control. Asian Chinese have different type of obesity, different style of diet, and a~     relatively low BMI levels as well. We assess the feasibility and efficacy of laparoscopic~     roux-en-Y gastric bypass surgery (LRYGB) in patients with non-severely obese T2DM.Taking into~     account the differences of body size and diet between the United States & Europe and Asian~     countries, diabetic situation has its special features in different regions, especially in~     Asia China. Asian Chinese have a high incidence of T2DM and a relatively low BMI levels.~     Evaluating the benefits from LRYGB for T2DM in Asian Chinese diabetes subjects with a body~     mass index of less than 35kg/m2 and looking for sufficient evidence to this operation become~     necessary.The patients will be followed up for one year after surgery and a comparison would~     be made between the two groups. Clinical indicators that reflect the effect of LRYGB are~     monitored before surgery and 1, 3,6,12 months after surgery. Complete remission of diabetes~     was defined by hemoglobin A1c (HbA1c)<6.0% and Fasting plasma glucose (FPG)<5.6mmol/L.~   "
112776|NCT02091297|"~     More and more women are on buprenorphine or methadone during pregnancy for a history of~     opioid addiction. Currently, pain control after cesarean section for women already on these~     medications, if they need operative delivery, is a challenge due to the pharmacology of those~     drugs. They have higher pain scores and 45-47% higher opiates requirement. To improve pain~     control, some unique regional anesthesia techniques have been employed, besides opioid and~     non-opioid medication management through the oral, intravenous, and/or neuraxial (spinal or~     epidural) route. One is a TAP block ( transversus abdominis plane block), a regional~     anesthesia procedure in which long acting local anesthetic, such as ropivacaine, is injected~     on both sides of the patient's abdomen to numb the nerves supplying the abdominal wall, or~     the surgical site. Another is a patient - controlled epidural, a small flexible catheter that~     is inserted in the back into the epidural space near the spine, which bathes the spinal nerve~     roots with long acting local anesthetic, such as bupivacaine, and with an opioid, such as~     fentanyl, to numb the nerves going to the surgical site. Through an epidural pump, the~     patient receives a continuous infusion of local anesthetic and can delivery more medication~     as needed through a bolus feature. There have case reports, or case by case accounts, of~     these techniques, and it is suspected these techniques result in better pain control with~     minimal side effects. No clinical, human or animal, has evaluated these techniques in a~     controlled and through manner, either comparing the two techniques to each other or comparing~     them to the common care of opioid and non-opioid medication management through the oral,~     intravenous, and/or neuraxial route, including neuraxial hydromorphone or morphine.~   "
112777|NCT02091284|"~     In this study, eligible alcoholic inpatients recruited from a specialized clinic for~     addiction treatment, filling inclusion criteria and not showing any exclusion criteria, will~     be randomized to receive the repetitive (5 sessions, every other day) bilateral dorsolateral~     Prefrontal Cortex (dlPFC: cathodal left / anodal right) tDCS (2 milliamperes, 5 x 7 cm2, for~     20 min) or placebo (sham-tDCS). Craving to the use of crack-cocaine will be examined before~     (baseline), during and after the end of the tDCS treatment. Other clinical outcomes, and also~     visual P3 event-related potential and neuroimagings exams will be also performed before and~     after treatment.~      Based in our previous data, our hypothesis is that repetitive bilateral tDCS over dlPFC will~     favorably change clinical, cognitive and brain function in alcoholism and these will be~     long-lasting effects.~   "
112778|NCT02091271|"~     The National Institute on Aging (NIA) Intramural Research Program (IRP) has a number ofiRB~     approved research studies involving human subjects, both normal volunteers and patients. As a~     means of identifying interested volunteers and other participants in the research process,~     this screening mechanism is established to identif'y potential eligible participants for NlA~     protocols.~      To participate, volunteers/patients must meet the specific requirements of at least one of~     the available NlA research studies; this protocol serves as a first step for admitting~     volunteers/patients to an appropriate approved protocol and creating a contact database for~     approved NlA studies.~      This protocol will facilitate their recruitment into NIA approved studies and provide NlA~     staff the opportunity to examine subjects where diagnostic observations can be documented and~     evaluated for research potential.~   "
112779|NCT02091258|"~     Tooth loss in periodontitis patients is associated with patient and site factors as well as~     with treatment provided. Not much is known about long-term tooth loss in periodontitis~     patients in private practice in the UK. The study plans to follow-up 200 subjects with~     periodontitis (and currently on maintenance therapy) for 5 years. The effect of treatment~     provided, site and patient risk factors on tooth loss will be studied.~   "
112780|NCT02091245|"~     This research study involves participants who have acute lymphoblastic or acute myelogenous~     leukemia that has relapsed or has become resistant (or refractory) to standard therapies.~     This research study is evaluating a drug called KPT-330. Laboratory and other studies suggest~     that the study drug, KPT-330, may prevent leukemia cells from growing and may lead to the~     destruction of leukemia cells. It is thought that KPT-330 activates cellular processes that~     increase the death of leukemia cells. The main goal of this study is to evaluate the side~     effects of KPT-330 when it is administered to children and adolescents with relapsed or~     refractory leukemia.~   "
112781|NCT02091232|"~     This research study is for patients who are going to receive a kidney transplant from a~     living donor. After kidney transplantation, it is necessary for transplant recipients to take~     immunosuppressive drugs. These drugs work by preventing the body's immune cells from~     attacking and rejecting the new kidney. Taking these drugs long-term may also cause harm to~     the transplanted kidney. Therefore, the transplant community is very interested in finding~     ways to decrease immunosuppressive drug treatment and further reduce the risk of kidney~     rejection. One method to do so is known as induction of tolerance, which is when the person~     who receives a transplant has treatment to make their immune cells tolerant to the donor~     cells.~      In this study, we will try to induce tolerance by mixing recipient cells and their donor's~     cells together with belatacept, an immunosuppressive drug. Belatacept is a protein that~     attaches to immune system cells, interferes with the immune response and results in tolerance~     induction.~      After we mix the recipient cells with the donor's cells, we will sort out one particular kind~     of immune cell, called a regulatory T cell, and inject them back into the recipient.~     Regulatory T cells are the cells that are affected by induction to reduce rejection of~     donated organs. This method for inducing tolerance has been used in bone marrow~     transplantation, but this is the first time it is being done in kidney transplantation.~      This study is being conducted as part of a unique collaboration of US and EU centers called~     The ONE Study. The ONE Study centers have agreed to work together using common protocols and~     procedures but with each testing their own regulatory population for safety and the ability~     to promote kidney survival. Sharing data among the participating sites will permit a deeper~     understanding of how and why some treatments might succeed while others work less well.~   "
112790|NCT02091115|"~     Constipation is a disorder which can be associated with various pathologies or could also be~     an effect of the consumption of drugs, improper diet and life style. Is increasingly common~     the utilization of probiotics in foods. Probiotics are defined as live microorganisms~     administered in adequate amounts confer a health benefit to the host, the most widely used~     for milk-based drinks are lactic bacteria Lactobacillus and Bifidobacterium. The objective of~     the present study is to assess the effectiveness of the consumption of dairy beverage~     enriched with probiotic for the treatment of the symptoms of constipation.~   "
112791|NCT02091102|"~     The purpose of this study is to evaluate the efficacy and safety of the treatment of wrinkles~     using a 755nm Alexandrite Laser.~   "
112792|NCT02091089|"~     The purpose of this study is to evaluate the efficacy and safety of the treatment of wrinkles~     using the picosecond 755nm Alexandrite laser.~   "
114506|NCT02068664|"~     The purpose of this study is to determine if stroke survivors with aphasia have spatial~     neglect (Phase 1). If they are determined to have the condition Phase 2 will be offered:~     which is prism adaptation treatment. This is a pilot study that will be performed with 4-5~     subjects.~   "
112782|NCT02091219|"~     The purpose of this study is to compare the effects of two different forms of vitamin D~     supplements (vitamin D3 and 25-hyrdroxyvitamin D3 [25(OH)D3]) on vitamin D levels in the~     blood, and on markers of skeletal and immune health. This study is designed as a pilot study.~     A multi-ethnic cohort of 48 patients will be included (12 Caucasian, 12 African American, 12~     Hispanic/Latino, 12 Asian/Asian American). Potential study candidates will undergo a~     screening visit during which a medical history will be taken, a physical exam performed, a~     dietary questionnaire administered, and blood collected. The purpose of the screening visit~     is to identify vitamin D-deficient (25-hydroxyvitamin D <20 ng/ml) individuals who are~     candidates for vitamin D supplementation. Eligible patients will then be randomly assigned to~     receive either vitamin D3 (2400 IU/day) or 25(OH)D3 (20 mcg/day) for 16 weeks. After~     initiating supplementation, study patients will return for follow-up visits at weeks 4, 8,~     and 16. At each visit, blood will be collected to assess vitamin D levels in the blood, as~     well as markers of skeletal and immune function. Participation in this study will therefore~     involve a total of 5 visits (1 screening visit, 1 randomization visit during which~     participants will receive their study supplements, 3 follow-up visits). After all data is~     collected, changes in vitamin D levels in the blood following supplementation with either~     vitamin D3 versus 25(OH)D3 will be determined, and correlated to markers of calcium balance~     and immune function. Knowledge gained from this study may have a significant impact on how~     vitamin D status is defined, and how vitamin D repletion is administered.~   "
112783|NCT02091206|"~     To evaluate the safety and pharmacokinetics of multiple doses of GWP42003-P compared with~     placebo in children with Dravet syndrome.~   "
112784|NCT02091193|"~     The purpose of this study is to evaluate the effects of krill oil supplementation in patients~     with Type 2 diabetes mellitus on heart health and laboratory diabetic measurements.~      Patients who enroll in this study will be asked to visit the Western Connecticut Health~     Network Biomedical Research Institute on 3 separate occasions: for baseline testing, after 4~     weeks of supplementing with krill oil, and after 4 weeks of supplementing with a placebo.~     Patients will be randomized into one of two groups to determine the order in which they~     receive the supplement and placebo. Every patient will receive both the krill oil and the~     placebo, but both the coordinator and the patient are blinded to which is which. At each~     visit, participants will undergo a non-invasive test which measures the function of the inner~     lining of blood vessels and they will also have blood drawn. Fasting is required before each~     appointment. The blood drawn is used to measure their Hemoglobin A1C, Glucose, HDL, LDL,~     total cholesterol, C-peptide and total antioxidant capacity.~      Risks to taking krill oil supplements are likely to include bad breath, heartburn, fishy~     taste, upset stomach, nausea, loose stools, gas, and bloating. Risks of EndoPAT testing are~     not permanent and may include pain, numbness, tingling, redness, and bruising at the site of~     the blood pressure cuff. Risks that are associated with drawing blood may include redness,~     swelling, pain or discomfort, bruising at the site of the needle stick, or in very rare~     cases, infection at the needle site. To minimize these risks, trained technologists and~     phlebotomists will be used for all procedures.~      This is not a treatment option; while involved in this study all participants will continue~     their regular treatment for Type 2 diabetes mellitus (as well as any other applicable~     conditions).~   "
112785|NCT02091180|"~     Decreased cerebral oxygen saturation (rSO2) was reported to occur during insufflation for~     laparoscopic procedures due to increased Intracranial pressure (ICP) with resultant decrease~     in cerebral perfusion pressure.~   "
112786|NCT02091167|"~     In this study, eligible crack-cocaine addicted inpatients recruited from a specialized clinic~     for addiction treatment, filling inclusion criteria and not showing any exclusion criteria,~     will be randomized to receive the repetitive (5 sessions, every other day) bilateral~     dorsolateral Prefrontal Cortex (dlPFC: cathodal left / anodal right) tDCS (2 milliamperes,~     3x7 cm2, for 20 min) or placebo (sham-tDCS). Craving to the use of crack-cocaine will be~     examined before (baseline), during and after the end of the tDCS treatment. Other clinical~     outcomes, and also visual P3 event-related potential and neuroimagings exams will be also~     performed before and after treatment.~      Based in our previous data, our hypothesis is that repetitive bilateral tDCS over dlPFC will~     favorably change clinical, cognitive and brain function in crack-cocaine addiction and these~     will be long-lasting effects.~   "
112787|NCT02091154|"~     The investigators hypothesize that the new United States Department of Agriculture (USDA)~     regulations for lunches served as part of the National School Lunch Program will decrease the~     percentage of enrolled students purchasing lunch, increase the percentage of children taking~     fruit and vegetables, decrease the percentage of fruit and vegetable servings being thrown~     away, and increase the total number of fruit and vegetable servings eaten.~      The investigators also hypothesize that when the regulations are in force, simple behavioral~     interventions can counteract the potentially negative impact on lunch sales and consumption.~     In other words, implementing the regulations and behavioral interventions together, the~     percentage of enrolled students taking a school lunch will increase at least back to baseline~     levels, the percentage of children taking fruits and vegetables will increase, the percentage~     of fruit and vegetable servings wasted will decrease, and the total number of fruit and~     vegetable servings eaten will increase.~   "
112788|NCT02091141|"~     This multicenter, non-randomized, open-label study will evaluate the efficacy and safety of~     six treatment regimens in participants with advanced solid tumors for whom therapies that~     will convey clinical benefit are not available and/or are not suitable options per the~     treating physician's judgment.~   "
112789|NCT02091128|"~     With this study, in which the incidence of pregnancy in classic galactosemia patients is~     studied, we aim to provide new insights to improve counselling. Our hypothesis is that the~     chance that a galactosemic woman with POI becomes pregnant is higher than the 5-10% that has~     been reported for women with POI due to other causes. Chance of spontaneous pregnancy will be~     evaluated through semi standardized interview in women with classic galactosemia aged 18~     years or older. During the interview, questions will be asked regarding fertility and~     pregnancy.~   "
112820|NCT02090725|"~     The main purpose for this study is to provide access to 3,4 DAP, a drug which has~     demonstrated to be effective in treating weakness associated with Lambert-Eaton Myasthenic~     Syndrome. LEMS is a rare autoimmune cause of a defect in neuromuscular transmission. The~     disorder is clinically characterized by fluctuating muscle weakness, hyporeflexia and~     autonomic dysfunction.~   "
112793|NCT02091076|"~     A split-thickness skin graft (STSG) is used for a large wounds or wounds that cannot be~     closed by primary and secondary wound closure. Accelerated re-epithelialization rate and~     minimizing pain and infection are main goals of donor care. Traditionally dressings are~     inexpensive but adhere to the wound surface and cannot absorb exudates. Thus, we have~     developed a new biomaterial based on Thai silk for wound dressing application. Silk fibroin~     and silk sericin were selected to produce wound dressing in this study. The objective of this~     study is to compare wound dressing containing silk fibroin with bioactive coating layer with~     standard dressing (medicated paraffin gauze dressing; Bactigras®), with regard to healing~     time, patients' pain intensity, skin's transepidermal water loss after healing and evidence~     of infection in the treatment of split-thickness skin graft donor sites. The study design is~     a randomized, controlled, self paired clinical trial. Patients age 18 to 60 years and undergo~     STSG at thigh in Department of Surgery, King Chulalongkorn Memorial Hospital will be~     recruited in the study. The exclusion criteria are donor sites other than thigh area or~     located at high risk of infection. Patients who are immunocompromised or diabetes mellitus or~     psychiatric disorders or low serum albumin level (less than 3.0 g/dL) or known allergic to SS~     or SF or paraffin or chlorhexidine acetate are also excluded. All subjects sign the informed~     consents after discussion the protocol, benefits and risks. The donor site will be divided~     into two equal halves, each site will be randomized to receive the tested material or the~     medicated paraffin gauze dressing. The donor site wounds will be observed daily. The~     dressings will not be changed, except when they are fully soaked with exudates and easily~     fell off or any sign of infection. Healing time will be recorded when the dressing separate~     completely from the donor site, no exudates and no pain when the donor site is exposed to~     air. The patient's pain level will be evaluated with the visual analogue scale and the donor~     site wounds will be observed daily for signs of infection. On the day of the wound is~     recorded for healing time and 1 weeks, 1, 2, 3, 4 and 5 months after that, the skin barrier~     function (TEWL) of each site will be measured using a Tewameter. Blood sample will be~     collected from patients pre- and postoperatively (within day 3) for hepatic and renal~     function analysis.~   "
112794|NCT02091063|"~     This will be an open-label, single agent, multi-institutional phase Ib/II study of ACY-1215~     for the treatment of patients with relapsed or refractory lymphoid malignancies. The target~     population will include patients with histologically confirmed relapsed or refractory~     non-Hodgkin's lymphoma or Hodgkin's lymphoma, with an expansion cohort of patients with~     mantle cell lymphoma.~      The phase Ib will be conducted to determine the safety and tolerability of two dosing~     schedules of ACY-1215 monotherapy in patients with lymphoid malignancies. Patients will be~     accrued simultaneously to two dose cohorts (Arm A and Arm B) of ACY-1215. Selection into each~     cohort will occur by alternation. All patients will take the prescribed dose of ACY-1215~     orally for 28 consecutive days. Patients enrolled into Arm A will take ACY-1215 160 mg daily~     (QD), whereas patients enrolled into Arm B will take ACY-1215 160 mg twice daily (BID).~     ACY-1215 will be supplied as a liquid for oral administration (PO). Each dose will be~     administered at least 1 hour after ingestion of food followed by at least 4 ounces of water.~     Patients will be instructed not to ingest food or other oral medication for at least 2 hours~     after each ACY-1215 dose. Frequency in phase II will be determined based on Phase Ib results.~   "
112795|NCT02091050|"~     Demonstrate the limitations of conventional dosimetry (2D) for the adjuvant brachytherapy~     treatment and assess whether tridimensional dosimetry relates more faithfully with the~     occurrence of adverse effects.~   "
112796|NCT02091037|"~     The purpose of this study is to characterize the bacterial strains that colonize children~     with atopic dermatitis.~      The investigators hypothesize that rectal cultures will be more sensitive than anterior nares~     cultures for detecting S. aureus colonization, and that strains of S. aureus colonizing~     patients with atopic dermatitis will be resistant to commonly used topical antibiotic~     ointments.~   "
112797|NCT02091024|"~     The investigators performed a 12-week, randomized, double-blind, placebo-controlled human~     trial to evaluate the efficacy and safety of Ecklonia cava extract on hyperlipidemia.~   "
112798|NCT02091011|"~     The study is to determine the rate and cause of device replacements at 5 years~     post-implantation. It will assess the battery and device longevity of the Implantable~     Cardioverter Defibrillators (ICD) and CRT-D Cardiac Resynchronization Therapy Defibrillator~     (CRT-D) devices. It will also validate the device survival information given in Boston~     Scientific's Product Performance Report by comparing the pulse generator (PG) survival~     probability in the study to that presented in the Product Performance Reports (PPR)~   "
112799|NCT02090998|"~     This study will compare a local anesthetic technique that has been used to treat subjects~     suffering from transformed migraines (chronic migraines) versus medical management with~     traditional antidepressant Amitriptyline / Elavil.~      Subjects will be randomized into one of two treatment groups to compare the safety and~     efficacy of the therapies. Subjects will recieve either sphenopalatine ganglion nerve block~     with 5% lidocaine gel into the nasopharynx or medical management with traditional~     antidepressants, Elavil, to produce a reduction in the frequency and severity of the~     headache.~      We propose that there will be a difference in the outcomes when comparing the two methods of~     treating transformed migraines and that one research arm will result in more patient~     satisfaction and greater efficacy in the treatment of subjects~   "
112800|NCT02090985|"~     In this study a technique called 'lipomodelling' is being studied to find out if it is~     beneficial around the stoma site in patients who have difficulty with securing their stoma~     bags which may lead to leakage and frequent soiling which we believe reduces quality of life.~      Patients with colostomy (stoma formed by bringing large bowel to the surface of the abdomen),~     ileostomy (small bowel) or a urostomy (urinary tract) will be recruited into this study.~      Lipomodelling is a technique that is commonly used elsewhere in the body but to our knowledge~     has not been used for this purpose. This study is a pilot study that may lead to further~     research in this area.~      Lipomodelling means taking some of your own fat that lies just beneath the surface of the~     skin and transferring it to another part of your body. The fat is removed by suction~     (liposuction), normally from your thighs or abdomen. In order to use the most important part~     of the fat, it is then put into a machine called a centrifuge. This spins the fat so that it~     splits up into three different sections. The most important section is then separated and~     injected in very small quantities into the required areas around your stoma. It is thought to~     have cells that encourage rejuvenation as well as helping to fill the area injected.~      Peri-stomal means the area around the stoma itself, this includes skin and underlying tissue,~     which will be fat and scar tissue. After any operation there will be scarring that takes some~     time to fully develop. Usually after a year the scar tissue will be fully formed. The scar~     tissue may cause the skin around the stoma to be irregular. This is described as contouring~     of the skin.~      The aim of this study is to see if lipomodelling can improve your quality of life by reducing~     the frequency of changing your stoma bag, reduce leakage and the need for extra-stomal~     appliances to try and help the stoma bag fit to your body securely.~   "
112801|NCT02090972|"~     In this study, the risk of opioid medications on fractures in older adults is investigated.~     Patients from the surgical department with fractures and control patients from the internal~     department of the same hospital are inquired with a standardized questionaire about~     demographic and clinical risk factors for fractures. Osteoporotic fracture risk is assessed~     using quantitative ultrasound. An impact of recent opioid medications on fractures is~     hypothesised.~   "
112802|NCT02090959|"~     The main goal of this Phase 3 extension study is to obtain long term safety of ataluren in~     boys with nonsense mutation dystrophinopathy as determined by adverse events and laboratory~     abnormalities. The study will also assess changes in physical function, pulmonary function~     and other important clinical and laboratory measures.~   "
112803|NCT02090946|"~     The experiences of learning from paediatric physiotherapists were explored through~     unstructured interviews applying Colazzi's method to interpret the data. In this hermeneutic~     phenomenological study, six parents responsible for a physiotherapy home programme for their~     child were selected through convenience sampling. The purpose of this study was to obtain~     rich and valid information that could be analysed. The phenomenon of their learning~     experiences was formed and explored, its implications discussed and inferences made in light~     of current physiotherapy service delivery.~   "
112804|NCT02090933|"~     This clinical trial studies celecoxib in decreasing the damaging effects of sunburn in~     healthy volunteers. Celecoxib may reduce skin damage by blocking enzymes associated with~     sunburn in healthy volunteers.~   "
112805|NCT02090920|"~     This study looks at the effects of a mother's genes and other characteristics (mother's age,~     baby's age, race, and other diseases) on the ability of nifedipine to end contractions and~     prevent an early delivery. This information will be used to decide what amount of nifedipine~     women need to best treat preterm contractions.~   "
112806|NCT02090907|"~     Hypothyroidism is risk factor in atherosclerotic cardiovascular diseases, but there is a~     controversy in effect of subclinical hypothyroidism on cardiovascular diseases. We aim to~     estimate the relation between subclinical hypothyroidism and endothelial dysfunction and the~     effects of levothyroxine therapy on it. Patients with confirmed subclinical hypothyroidism by~     lab results will be randomized to two groups of treatment with one daily dose of 100 mg~     Levothyroxine or placebo. The flow-mediated dilation and intima media thickness are evaluated~     before and after the study.~   "
112807|NCT02090894|"~     The objective of this study is to examine the ability of dermal rejuvenation therapies to~     protect geriatric skin from ultraviolet light (UVB)-induced carcinogenesis. Skin cancers~     (including basal cell carcinoma and squamous cell carcinoma) are the most common types of~     malignancy and are related to UVB exposure in sunlight. UVB-irradiation of skin causes~     specific DNA damage to keratinocytes that can lead to cancer-causing mutations if they are~     allowed to persist in proliferating cells. Moreover, the incidence of skin cancers is much~     greater in elderly over younger individuals. The objective of the present study is to build~     upon our previous data and test the effect of a non ablative Nd:YAG laser (LaserGenesis) of a~     localized area of skin on dermal IGF-1 production and UVB-mediated keratinocyte effects.~     Treatment of skin using a non ablative high-peak power microsecond pulsed 1064 nm Nd:YAG~     laser (Cutera's LaserGenesisTM laser) leads to papillary dermal heating. The laser targets~     the microvasculature and stimulates collagen production while protecting the epidermis.~     Generally, Laser Genesis is used clinically to improve irregularities in the contour,~     texture, and color of the skin. Laser Genesis is also used to help treat photoaging by~     increasing collagen formation, suggesting that it stimulates fibroblast activity and thus~     possibly increases levels of protective IGF-1.~   "
112808|NCT02090881|"~     Sickle cell disease (SCD) affects haemoglobin - the molecule in blood cells which carries~     oxygen. It causes red blood cells to become abnormal crescent (or sickle)- shaped. Sickled~     red blood cells cannot travel through small blood vessels as easily as normal red blood cells~     which can lead to blockages. This means that oxygen may be prevented from getting to where it~     is needed. Individuals with sickle cell disease also suffer form abnormality in the lining of~     their blood vessels, which contributes to the damage.~      Damage and blockage can occur in the blood vessels in the brain and means that children with~     sickle cell disease have a significant risk of suffering from strokes. Research has shown~     that transcranial Doppler ultrasonography can be used in this setting to identify children at~     most risk of getting strokes.~      Ultrasound is therefore used in children with sickle cell disease to measure the blood flow~     in the vessels in the brain. This research has formed the basis of the National Health~     Service (NHS) Standard of Care for Sickle Cell Disease in the United Kingdom (UK) which uses~     transcranial Doppler ultrasonography at once a year to screen children with sickle cell~     disease aged 2 to 16.~      Ultrasound is used because it is portable, does not uses ionising radiation such as x-rays,~     is non-invasive and gives good results. However, the results are dependent on the operator.~     This means that the screening service is provided by centres of excellence with experienced~     scanning staff visiting clinics in smaller hospitals with portable machines. There is a lack~     of research comparing the use of portable machines to laboratory-based machines. This is~     important because screening can identify children at high risk of stroke and may be used by~     clinical staff to make a decision about the care of the child.~   "
112809|NCT02090868|"~     This study aims to explore how the introduction of an oral intake screening tool can benefit~     patients requiring noninvasive ventilation. The Quality Care Commission has identified~     nutritional problems in hospital and there is much literature on the importance of nutrition~     when critically ill. Literature is short however concerning the specialized population of~     those requiring noninvasive ventilation and they are a high risk group of suffering from~     malnutrition.~      This study will potentially benefit patients by improving their nutritional care through~     guided assessment and nurse training.~      The study will use mixed methodology, a prospective cohort study and qualitative interviews.~     The prospective cohort study will collect data from patients prior to the tool introduction,~     the control group, and post the tool introduction, the exposure group. This will enable~     comparisons to be made between the exposure and the control groups.~      Nurses will be interviewed in semi structured focus groups prior to tool introduction and~     post to identify themes and sub themes to give a deeper understanding of nutrition in~     hospital and to examine the use of the tool in practice.~      Patients will be eligible if they are over 18 and requiring noninvasive ventilation and~     nurses will be eligible if they work on the high dependency unit. Patients will be visited~     daily and have four mid arm circumference measurements at day 1, day 3, day 7 and day 14. The~     other daily visits will involve collecting data, which is recorded as part of routine care.~      Nurses will undergo 2 focus group interviews and a teaching session. The study will take~     place at St Mary's hospital funded by Imperial College London. The study will be split into~     two periods with a two week gap in between. Each period will last until 22 patient~     participants have been recruited.~   "
112835|NCT02090530|"~     Precision Cancer Medicine for Advanced Cancer Through High-throughput Sequencing~   "
114701|NCT02066077|"~     1. To determine the influencing factors of modified electroconvulsive therapy (MECT);~        2. To determine the influencing factors and reversibility of the cognitive impairment~          caused by MECT;~        3. To determine the duration of efficacy of MECT and its affecting factors.~   "
112810|NCT02090855|"~     Data from subjects who had previously been dosed with Flutemetamol (18F) Injection and imaged~     in Study GE-067-007, and who died on or before 10 June 2013, will be analyzed. The PET brain~     images previously obtained in Study GE-067-007 will be interpreted visually in randomized by~     5 independent readers who are blinded to all other subject information, and the images will~     be classified as abnormal (positive for abnormal neuritic plaque density) or normal (negative~     for abnormal neuritic plaque density). The numbers of images in each category will be used to~     calculate sensitivity and specificity.~   "
112811|NCT02090842|"~     Epidemiological studies demonstrated an inverse associations between cardiovascular events~     and milk and dairy product consumption. Evidence from human intervention studies suggests~     that both whey and casein may be effective in blood pressure-lowering, however there is~     limited data on the impact of milk proteins on vascular function. This research aims to~     compare the potential acute and chronic impacts of the two main milk proteins (whey and~     casein) with maltodextrin on blood pressure and vascular function. Furthermore, the effects~     of these proteins on the markers of insulin resistance, lipid metabolism and inflammatory~     status will also be investigated in 'at-risk' individuals.~      This research includes both an acute and chronic intervention study which have been~     independently powered on the appropriate outcome measures. This has generated different~     sample size requirements for the two studies (Actual participants on the acute study: n=27,~     and on the chronic study: n=38).~   "
112812|NCT02090829|"~     : The objective of this study is to determine the tolerability and therapeutic potential of~     oxytocin in children and adolescents with Autism Spectrum Disorders (ASD) when paired with a~     computer game intervention that is designed to enhance face perception skills. We designate~     two measures as our primary outcomes, based on prior published work with these interventions,~     and we propose a sample based on power analyses from these prior results. A second objective~     of this study is to learn about the breadth of possible positive effects that this~     combination therapy might have for children with ASD. To this end, we include a host of other~     exploratory measures that assess aspects of social motivation and attention, social~     perception, and social cognition. Thus, a second objective is to conduct a signal finding~     study - to gather outcome data on a range of dependent variables that theoretically should be~     related to oxytocin's effects on social processes, but for which there are no prior data. The~     signal finding aspect of this study will provide the preliminary data needed to design a more~     targeted follow up study.~   "
112813|NCT02090816|"~     The purpose of this study is to determine whether J-shaped thoracophrenolaparotomy is~     effective in the surgical treatment of simultaneous liver and right lung metastases from~     colorectal cancer~   "
112814|NCT02090803|"~     The purpose of this study is to assess the human herpes virus reactivation 6 post autologous~     stem cells in 196 patients. The aim of our study was to describe the incidence of~     reactivation of HHV-6 in patients requiring autologous HSCT and determine the pathogenic role~     in this target population.~   "
112815|NCT02090790|"~     the aim of this study was to investigate compare the effect of peroperative intravenous~     single dose dexamethasone and the addition of dexamethasone to femoral nerve block on~     postoperative analgesic consumption and patient comfort in unilateral total knee arthroplasty~     patients~   "
112816|NCT02090777|"~     The study will be conducted to examine the feasibility of using a Health Coach for improving~     the ophthalmic care of glaucoma patients. Patients taking glaucoma medications will have a~     coaching intervention and adherence to glaucoma drops will be monitored using a~     dose-recording device. The dosing data will be analyzed to examine the effect on adherence~     and qualitative interviews at the conclusion of the study will be used to examine which~     elements of the coaching experience were most helpful in the glaucoma patient population.~   "
112817|NCT02090764|"~     This is multicenter, randomised, placebo controlled, parallel, double blinded , superiority~     clinical study comparing ozenoxacin cream versus placebo, in patients with a clinical~     diagnosis of non-bullous or bullous impetigo.~   "
112818|NCT02090751|"~     Age Related Macular Disease (AMD) is easily the leading cause of blindness in older people in~     developed countries. It affects between 30 and 50 million individuals worldwide, with around~     30% of the over 65's showing early signs of the disease. Severe AMD has a devastating impact~     on the quality of life; it causes extensive visual impairment, making reading difficult and~     driving impossible. Patients lose their independence and become a major burden on public~     health systems.~      Present treatment options are limited. Many new therapies are under development and all will~     need evaluation using a test with high specificity and sensitivity for early AMD. The present~     application will develop such an instrument. The prototype was funded by a previous i4i FS~     (feasibility study ll-FS-0110-14036). The new device measures sensitivity to a dim flickering~     light using the same principle as an established european conformity marked (CE marked)~     instrument. The original method involved lights of different wavelengths and higher~     intensities.~      The instrument in this study assesses night vision, which is selectively damaged in early~     stage AMD. In low lighting, the investigators vision depends on specialized rod~     photoreceptors. Cone photoreceptors, which provide daytime vision, remain normal in the early~     stages of the disease. By the time patients complain of reduced (cone-based) visual acuity,~     they will have had the disease for many years and lost many thousands of photoreceptors.~   "
112819|NCT02090738|"~     Helicobacter pylori infection is associated with several gastric diseases, including~     gastritis, peptic and duodenal ulcers, gastric carcinoma and MALToma. In 1994, the WHO~     classified the organism as a type 1 carcinogen. In order to eradicate H. pylori, at least two~     antibiotics and a proton pump inhibitor are used as a standard therapy regimen. Emerging~     antibiotic resistance to metronidazole or clarithromycin, however, has made successful~     treatment of infection progressively more difficult, with the success rate of standard triple~     therapy now at 70%, well below the 80% required for treatment of infectious diseases.~     Therefore, new treatment regimen is required for successful H. pylori eradication.~      On the other hands, many in vitro studies revealed that bacterial carbonic anhydrase in H.~     pylori has an important role for surviving of H. pylori in the stomach. It was demonstrated~     that mutation of carbonic anhydrase affected survival of H. pylori. The investigators~     therefore expected that administration of carbonic anhydrase inhibitor (acetazolamide) with~     standard H. pylori eradication regimen would increase the eradication rate. Here, the~     investigators aim to evaluate the efficacy of standard triple regimen plus acetazolamide for~     H. pylori eradication.~   "
112821|NCT02090712|"~     At the periphery of the city of São Paulo, in-hospital mortality in acute myocardial~     infarction is estimated to range between 15% and 20% due to difficulties inherent to delayed~     answer at a large metropolis. As a city with more than 11 million inhabitants, the~     distribution of emergency services and public hospitals is also heterogeneous, with scarcity~     in peripheral zones. That heterogeneity of resources also involves the quality of the medical~     care provided. The possibility of a standard care with fast transfer after thrombolysis and a~     tertiary backing system for ECG interpretation, catheterization and advanced support could~     improve this setting.~      In a project initiated in 2010, the São Paulo Municipal Health Secretariat, the Federal~     University of Sao Paulo/Paulista School of Medicine, the Emergency Mobile Health Care Service~     arranged a planed system of thrombolysis at peripheral hospitals or at the ambulances with~     immediate transfer to a unique tertiary center for early angiography and angioplasty of the~     culprit artery. The protocol uses recommendations of Brazilian and international guidelines,~     and is the same adopted for the management of ST elevation myocardial infarction at Paulista~     School of Medicine regarding the indications for thrombolytic agents, primary and rescue~     percutaneous transluminal coronary angioplasty (PTCA), and pharmacoinvasive therapy.~      The hypothesis of this study is that a network to provide the best care for patients with ST~     elevation myocardial infarction will reduce mortality rates.~      The main purpose of this registry is to provide demographics, metrics and results of this~     experience, maintaining complete records of clinical, laboratory and coronary angiography~     data of all patients allowing short-term outcome analysis of various variables in a large~     population. Additionally, follow-up outcomes will be provide in a sub-group of patients~     keeping their health care at the University or able to be tracked.~      All clinical endpoints of main interest will be assessed as single or composite endpoints for~     evaluation at different time intervals.~   "
112822|NCT02090699|"~     Cardiac failure is the major cause of death in patients with thalassemia and chronic blood~     transfusion-related iron overload. The treatment of thalassemia has been revolutionized over~     the past decade with the implementation of cardiac MRI based assessment of iron overload.~     This has enabled detection of cardiac iron overload prior to symptomatic heart failure and~     now allows for timely therapy which has resulted in a substantial decrease in mortality.~     However, currently implemented MR imaging techniques assess for iron content only and not for~     iron related diffuse fibrosis which play a role in iron related heart failure.~     Histopathologic studies indicate that patients with iron overload have diffuse interstitial~     fibrosis. Quantitative MR techniques have shown that patients with various cardiomyopathies~     demonstrate diffuse myocardial fibrosis and that these changes correlate with changes in~     cardiac function. The investigators propose that quantitative cardiac MRI for assessment of~     diffuse myocardial fibrosis can further improve our ability to detect early damage to the~     myocardium and prevent morbidity and mortality from cardiac iron overload. Detection of~     fibrosis in patients with thalassemia may allow for earlier identification of cardiomyopathy~     when compared to other techniques in clinical use including T2* analysis. Identification of~     fibrosis could affect patient management as it would allow for tailoring of iron chelation~     therapy and may lead to better understanding of the disease processes contributing to heart~     failure and arrhythmia in these patients.~   "
112823|NCT02090686|"~     The purpose of this study is to determine whether pulsatile cupping with a cupping device is~     effective in the treatment of patients with chronic low back pain compared to no cupping or~     to minimal cupping.~   "
112824|NCT02090673|"~     The objective of this regulatory Post-Marketing Surveillance in Korea is to reconfirm the~     clinical usefulness of Exenatide through collecting, reviewing, identifying and verifying the~     safety and effectiveness information about Exenatide in general practice.~   "
112825|NCT02090660|"~     This study will determine the feasibility of the novel Indocyanine Green (ICG) fluorescence~     localization technique with a Laser fluorescence thoracoscope system.~      The primary objective of this study is to prove the validity and safety of our novel~     fluorescent localization method with utilized ICG and novel near infra-red fluorescence~     videoscope system.~   "
112826|NCT02090647|"~     The objective of the study was to assess the aesthetic outcome of different abutments~     materials and shapes on dental implants .~      A set of parameters, including assessments of the mucosa and periodontal tissue , soft tissue~     , radiographic evaluations and clinical photographs, was used to obtain a measure of the~     aesthetic of implant-prosthesis rehabilitations.~   "
112827|NCT02090634|"~     Adherence to combination antiretroviral therapy (ART) is critical for successful HIV viral~     suppression. Nonadherence to ART poses several potentially serious health consequences,~     including higher viral loads, faster progression to AIDS, and a heightened risk of viral~     mutations, treatment resistance and HIV transmission.~      The prevalence of serious mental illness (SMI) conditions, including bipolar disorder (BD),~     is elevated among HIV-infected populations and is associated with poor ART adherence.~     HIV-infected individuals with co-occurring BD (HIV+/BD+), when compared to demographically~     similar HIV+/BD- persons, demonstrated poorer ART and psychotropic medication adherence and~     were twice as likely to be non adherent to their ART regimen using a ≥ 90% cutoff score.~     HIV+/BD+ individuals are particularly at-risk for medication non adherence, and there is a~     critical need to develop interventions to improve adherence in this population.~      Poor psychotropic medication adherence is also common among people with SMI - it has been~     estimated that 40% of those with BD do not take their mood stabilizer as prescribed. Among~     persons with BD, nonadherence to psychotropic medications can lead to greater risk for manic~     and depressive episodes, decreased quality of life, suicide attempts, and hospitalization.~      The utilization of mobile health (i.e., mHealth) technologies to improve everyday functioning~     is growing. mHealth interventions capitalize on technology already incorporated into most~     people's daily lives (e.g., cell phones) to assist people with behavior modification and~     disease self-management. Text messaging, in particular, may support daily ART adherence by~     delivering reminders at precise times to match an individuals' dosing schedule. The initial~     evidence for using text messaging to improve ART medication adherence has been compelling.~     Researchers and clinicians have also started employing technology-based approaches to improve~     treatment for individuals with BD.~      Taken together, a distinct need for RCTs utilizing text messaging to improve medication~     adherence within an at-risk HIV population is warranted. Individualized Texting for Adherence~     Building (iTAB) is one such intervention.~      The investigators propose an intervention development study designed to address these~     potential mechanisms of nonadherence with the following Specific Aims: 1) To further develop~     and refine a personalized, automated, real-time, mobile phone, text messaging intervention~     (iTAB) designed to improve adherence to ART and psychotropic medications among HIV+/BD+~     persons; 2) To evaluate the acceptability and effectiveness of a brief psychoeducation plus~     text messaging intervention (iTAB) as compared to psychoeducation alone (CTRL) for the~     improvement of objectively measured medication adherence among HIV+/BD+ persons; and 3) To~     examine predictors of within-person trajectories of nonadherence using the longitudinal data~     collected over the study. In order to realize these aims, the investigators will leverage the~     infrastructure of two unique UCSD resources increasing likelihood of study success, impact,~     and innovation: 1) the HIV Neurobehavioral Research Program (HNRP), which encompasses~     multiple NIH-funded studies that focus on the effects of HIV infection, and 2) the California~     Institute for Telecommunications and Information Technology (Calit2), which conducts research~     on state-of-the-art wireless means of health promotion. Initially, the investigators will~     refine the iTAB intervention to ensure that it is user-centered and tailored to the needs of~     HIV+/BD+ persons via focus groups and rapid prototyping. Once refined, the proposed iTAB~     intervention will use text messages that are automated, scalable, personalized, interactive,~     flexible, and motivating. The investigators will assess the acceptability and effectiveness~     of iTAB in improving objectively measured adherence (i.e., MEMS caps) over a 4-week period~     via a pilot RCT with 25 HIV+/BD+ assigned to the iTAB intervention and 25 HIV+/BD+ assigned~     to a psychoeducational control. Predictors of nonadherence including neuropsychological~     impairment, and mood will be examined to determine whether iTAB is better able to compensate~     for these factors associated with nonadherence as compared to CTRL. Further refinement to the~     iTAB intervention will be made in order to pursue a large-scale R01 using the investigators~     tailored intervention.~   "
112828|NCT02090621|"~     The purpose of this study is to determine the safety of photopheresis for prophylaxis of~     allograft rejection in patients who are being withdrawal immunosuppression after liver~     transplantation.~   "
112829|NCT02090608|"~     Proteinuria is the predominant risk factor for renal disease progression in Fabry disease~     (FD). When urine protein excretion is controlled to <0.50 g/24 hr, the rate loss of~     glomerular filtration rate (GFR) is not significantly different from 0. However, enzyme~     replacement therapy (ERT) alone does not decrease proteinuria and it has been recommended~     that patients receiving ERT also receive anti Renin-Angiotensin-System (RAS) therapy.~     Emerging evidences show that paricalcitol (PCT) reduces proteinuria in presence of~     intensified inhibition of RAS; however, there is no evidence in FD. The aim of this study is~     to evaluate the antiproteinuric effect of PCT in FD patients with proteinuria >0.50 g/24 hr~     persisting despite the ERT and anti-RAS therapy titrated to maximum tolerated dosage.~   "
112830|NCT02090595|"~     Children who have parents with bipolar disorder are at risk for developing anxiety disorders.~   "
112831|NCT02090582|"~     The purpose of this study is to test the effect of the gynecologic oncologists with~     palliative care specialist collaboration (GO-PC) intervention on patient quality of life.~   "
112832|NCT02090569|"~     High Resolution Imaging of Cerebral Vasculature by Functional Micro-Doppler Sonography During~     Brain Surgery (ULYS)~   "
112833|NCT02090556|"~     The purpose of this study is to estimate the retention rate of Abatacept SC over 24 months in~     routine clinical practice, in rheumatoid arthritis patients, in each country involved in the~     study. The purpose of the UK substudy is to explore whether integrating self-assessment into~     routine care could maintain tight control (of inflammation/disease activity) and at~     potentially lower cost resulting in improved health outcomes and cost-effectiveness.~   "
112834|NCT02090543|"~     According to recent guidelines, long-term anticoagulation is recommended for patients with~     atrial fibrillation (AF) and a risk profile with CHA2DS2-VASc score of 1 or more. Vitamin K~     antagonists(VAK) and novel oral anticoagulants such as rivaroxaban are current treatment~     options for AF patients with additional risk factors for stroke. Currently there are only~     limited information to what extend AF patients prefer one or the other treatment option based~     on patient relevant characteristics of novel oral anticoagulants vs. VKAs. It is also unknown~     which of the characteristics influences patient preference most and how this relates to a~     neutral comparator. Furthermore, an additional unknown factor is also how patient evaluate~     their current treatment and if this leads to differences among treatment with VKAs and~     rivaroxaban.~   "
112836|NCT02090517|"~     The aim of this study is to compare the efficacy of various treatment options for eliminating~     nasal telangiectasias. The study will compare the outcome of treating nasal telangiectasias~     with the following; no treatment (control site), alexandrite laser, pulsed dye laser,~     combination pulsed dye laser and Nd:YAG 1064nm multiplex laser system and electrosurgery.~   "
112837|NCT02090504|"~     Benzodiazepines (BDZs) are the gold standard in the treatment of alcohol withdrawal syndrome~     (AWS). Gamma-Hydroxybutyric acid also known as sodium oxybate (SMO) has been tested as a~     treatment for AWS with encouraging results. Aim of this phase IV, multicenter randomized~     double-blind, double dummy study is to evaluate the efficacy of SMO in comparison to oxazepam~     in the treatment of alcohol withdrawal symptoms (AWS).~   "
112838|NCT02090491|"~     Autism Spectrum Disorder (ASD) is a collection of complex neurodevelopmental disorders~     characterized by qualitative impairments in socialization, communication, and circumscribed~     interests, including stereotypical behavior patterns and behavioral rigidity to changes in~     routines (American Psychiatric Association, 1994). ASD is the fastest growing pervasive~     developmental disorder of childhood, currently estimated to affect 1 in 88 school age~     children (Baio, 2012). ASD typically manifests in infancy and persist throughout the~     lifespan. There is no known cause or cure for ASD, yet structured behavioral interventions~     and medications can enhance developmental outcomes. ASD has a profound impact on families and~     often result in enormous emotional and financial costs. Recent estimates suggest that~     societal costs in the US to care for all individuals diagnosed each year over their lifetime~     approaches $35 billion (Ganz, 2007).~      Janssen Research & Development is building a comprehensive digital platform (MENTIS) to~     optimize and enhance development of novel medicines and track outcomes in individuals with~     ASD. The MENTIS platform contains several core components, including: (1) An electronic~     personal healthcare record, designed specifically for individuals with ASD and their~     caregivers (parents, teachers, healthcare providers); (2) Integrated physiological and~     physical activity biosensors designed to objectively assess outcomes important in ASD, and;~     (3) A de-identified research data warehouse with analytic tools to better measure outcomes,~     assist with sub-population identification, and identify algorithms for diagnosis and~     treatment response detection.~      The MENTIS platform is currently being designed, developed, and prepared for testing. During~     this process it is highly desirable to conduct feasibility and usability research with a~     sample of the target population to identify important system components and features,~     optimize design, and reduce redundancy in software development and research time. The rapid~     pilot study described herein is proposed to gather incipient feedback on select MENTIS system~     components and features from stakeholders who support individuals with ASD in a clinical~     setting. This pilot research will help evaluate both how well current MENTIS system features~     work in an applied setting and inform future directions for MENTIS platform development.~   "
112839|NCT02090478|"~     The purpose of the study is to determine how reducing the amount of simple sugars in the diet~     affects sweet taste perception. Healthy adult subjects will be assigned to either follow~     their usual diet, or to replace sugar calories with fats or starch.~      The investigators hypothesize that eating less sugar will:~        1. cause foods and drinks with a given amount of sugar to taste sweeter~        2. cause people to prefer lower levels of sugar in foods and drinks~   "
112840|NCT02090465|"~     Assessment of treatment success and quality of life in patients with actinic keratoses under~     therapy with Ingenol Mebutate (Picato) in a period of 8 weeks.~   "
112841|NCT02090452|"~     The purpose of this study is to examine if real time transmission of vital signs, ECG and~     chat communication between the prehospital ambulances and the emergency department has an~     effect on patient mortality, ICU admission, hospitalization time, time to doctor, time to~     treatment and time to diagnostics~   "
112842|NCT02090439|"~     In the diagnosis of renal colic gallstone , in addition to clinical and biological factors,~     it is a key : medical imaging. Currently , the French recommendations require at least a~     couple of Abdomen radiography Without Preparation lying face (ASP ) associated with abdominal~     ultrasound . The abdominopelvic CT scan without injection of contrast is the examination of~     choice.~      Current recommendations in the management of gallstone colic simply based on the joint use of~     analgesics , anti inflammatory drugs and control of water intake .~      The mechanism of analgesic action of this treatment is a decrease in the pressure in the~     cavities by decrease in diuresis and inflammation treatment of ureteral permitting passage of~     urine . )~      The expulsive medical therapy remains under evaluation. The French Association of Urology~     does not recommend at this time for lack of evidence deemed sufficient.~      For foreign companies Urology (EAU , AUA) , the use of calcium channel blockers or alpha~     blockers in the treatment of symptomatic lower ureteral stones (4 to 10mm ) is recommended~     (grade 1A) . However, there are less formal studies of their effectiveness .~      Investigators wish to demonstrate the effectiveness of alpha in medical expulsive therapy for~     pelvic stones 4 to 10mm .~   "
112843|NCT02090426|"~     This trial investigates the value created by the highly innovative Camden Coalition of~     Healthcare Providers' Care Management Program: Link2Care. The program targets~     super-utilizers of the health care system - specifically adults with 2 or more~     hospitalizations in the last six months 2 or more chronic conditions, and 5 or more~     outpatient medications - with intensive case management services. In particular, a team of~     nurses, social workers, community health workers and health coaches, supported by real-time~     data of healthcare utilization, perform home visits, accompany patients to doctor visits, and~     help patients enroll in social-service programs. This approach aims to improve the~     self-sufficiency of patients in navigating the healthcare and social-service systems and has~     the potential to reduce healthcare costs and improve patient health.~   "
112844|NCT02090413|"~     The primary objective of the study is to evaluate whether 150 mg enteric-coated aspirin~     (acetylsalicylic acid [ASA]) taken twice a day (BID) with dimethyl fumarate (DMF)~     administration or 75 mg enteric-coated ASA taken once daily in the morning (QAM) with DMF~     administration reduces the incidence and/or severity of flushing events in subjects with~     relapsing-remitting multiple sclerosis (RRMS) compared with ASA-placebo administered with DMF~     in the clinical practice setting.~      Secondary objectives of this study are: to evaluate the safety and tolerability of DMF~     administered with and without enteric-coated ASA in the clinical practice setting; to~     evaluate the impact of DMF administration on quality of life as measured by the Short Form 36~     (SF-36®) and European Quality of Life - 5 Dimensions - 5 Levels (EQ-5D-5L) questionnaires.~   "
112845|NCT02090400|"~     The aim of this study is see the changes in bone mineral density after discontinuation or~     stop the use of bisphosphonates and make the switch to bazedoxifene).~   "
112846|NCT02090387|"~     The study will evaluate the effects of oral nutritional supplements (ONS) on attenuating the~     lean body mass (LBM) loss that occurs after bed rest.~   "
113070|NCT02087462|"~     This multicenter randomized controlled trial (RCT) will evaluate the therapeutic~     effectiveness and health-economics of electroacupuncture for sciatica due to intervertebral~     disc displacement in 3 compared groups: electroacupuncture, electroacupuncture plus traction,~     electroacupuncture plus traction and medication.~   "
112847|NCT02090374|"~     The investigators propose the development of a range of nasal spray challenge models to study~     the way the nose can respond to different types of nasal challenge that elicit different~     forms of inflammation.~      The investigators will carry out nasal challenge with bacterial and viral components and~     allergens. In this way the nasal upper respiratory tract mucosa is challenged with stimuli of~     the immune system, causing various types of inflammation. Samples will be taken by blotting~     the nostril surface and by scraping off tiny surface samples.~      The nose will be sprayed with a substance that is a single part of a bacteria or virus, or~     with an allergen. The material delivered by nasal spray is of high purity and is sterile,~     containing no live bacteria or viruses. The nasal spray substance contains molecular patterns~     that are recognised as foreign by the immune system, and at the right dose should stimulate~     the immune system, causing mild nasal inflammation. The study employs noninvasive methods of~     sampling using absorptive strips. These strips look and feel like tissue paper, and are~     applied to each nostril for a period of 1 min. A few pinhead-sized tissue samples are taken~     from inside the nose, using a small disposable sterile plastic probe that has a tiny scoop on~     its end. In the nasal lining fluid and tissue samples, measurement will taken of a range of~     molecules and cells that protect against infections and help the immune response.~      By spraying the nose with a challenge agent in this manner, the nasal immune response can be~     assessed, which can help us better understand how the human immune system cells and molecules~     respond to bacteria and viruses. In the future, this may allow the testing of new drugs and~     vaccines, by seeing if they decrease or stop the inflammation after the nasal challenge.~   "
112848|NCT02090361|"~     In reconstructive surgery , most losses of cutaneous substance require the use of a thin skin~     graft . This technique allows epidermization of the defect by applying a thin layer of~     autologous epidermis. It does not reconstitute the injured skin. Transplants cause retractile~     scars, adherent to the deep plan, that may require revision surgery . Since a decade , dermal~     matrices are mainly used in burned skin centers . The collagen -elastin matrix has the~     advantage to set up in the same operation that the skin graft and contain elastic fibers ,~     two assets which improve the results of skin grafting.~      Objective:~      Evaluation of the clinical efficacy of the addition of a dermal matrix to skin graft on Skin~     Foldability, at day 360.~      Methodology:~      This is a multicenter randomized study (CHU Caen , Amiens, Rouen and Lille)~      Conduct of the study :~      The transplant will be performed according to the protocol defined between inter -region~     surgeons. The implementation of the dermal matrix will be in the same surgical technique as~     thin skin graft ( group 1 ) or the thin skin graft will be performed alone ( group 2) time .~      Evaluation Criteria Main : Skin Foldability ( Uf ) assessed grafted site will be compared to~     the opposite side ungrafted evaluated at Day 360 . Quantitative data will be measured by a~     cutometer Skin Elasticity Meter 580 (Courage and Khazaba Electronic GmbH).~      To achieve the main objective, it is planned to compare the ratio between Uf graft site and~     the opposite healthy site between two groups: skin + matrix graft , or skin graft only. Thus,~     the Wilcoxon test for independent samples will be used to settle bilateral formulation~     between the null hypothesis ( there is no difference between the two groups ) and the~     alternative hypothesis ( there is a difference between the two groups ) . In determining the~     overall risk of first species to 5% and the power of this test to detect the 90% expected~     under the alternative hypothesis difference should be the main criterion for evaluating at~     least 59 patients in each group so 118 patients total.~      Prospect If the contribution of a dermal matrix in loss of skin substances improves skin~     pliability and reduces pain , functional and aesthetic sequelae grafts thin skin , the dermal~     matrix may be proposed as a complementary treatment in these indications.~   "
112849|NCT02090348|"~     The primary objective of this study is to determine whether dimethyl fumarate (DMF) taken~     over 12 months is effective in reducing Multiple Sclerosis (MS)-related fatigue, as measured~     by mean changes in the Fatigue Scale for Motor and Cognitive Functions (FSMC), in~     participants with relapsing-remitting multiple sclerosis (RRMS). The secondary objectives of~     this study are: To investigate changes from Baseline in FSMC and fatigue severity (Fatigue~     Severity Scale [FSS]) at 1, 3, 6, 9, and 12 months in participants receiving DMF; To assess~     the impact of DMF on patient-reported outcomes (PROs), including work productivity (Work~     Productivity and Activity Impairment-Multiple Sclerosis questionnaire [WPAI-MS]),~     health-related quality of life (Short Form Health Survey [SF-12]), depression (Beck~     Depression Inventory-Fast Screen [BDI-FS]), and sleepiness (Epworth Sleepiness Scale [ESS])~     at 6 and 12 months in participants receiving DMF; To examine whether an association exists~     between fatigue and baseline demographics (e.g., age and sex) and disease characteristics~     (e.g., disease duration, baseline disease activity, treatment history, expanded disability~     status scale [EDSS] score, and PROs); To assess any changes in fatigue-related medication~     use.~   "
112850|NCT02090335|"~     The goal of this project, which has not changed, is to improve the health and fitness of~     persons with serious mental illness (SMI) using an innovative model: In SHAPE Lifestyles.~     Participants are randomly assigned to the In SHAPE program or Health Club Membership and~     Education only.~      The three specific aims of this study are to:~        1. To compare the treatment groups with respect to improvement in physical fitness~          outcomes, including: (a) health behaviors (engagement in exercise and diet changes); and~          (b) indicators of physical fitness.~        2. To compare the treatment groups with respect to improvements in mental health outcomes,~          including negative symptoms, depression, and self-efficacy.~        3. To explore differences in the treatment groups with respect to psychosocial functioning,~          health status, and acute service use, and the effects of selected demographic, clinical,~          and health behavior variables on primary outcomes.~   "
112851|NCT02090322|"~     The Retinopathy of Prematurity (ROP) is a Retina's pathology only of the premature baby, it's~     characterized for proliferation of vascular tissue that grow in the limit between the~     vascular retina and the avascular retina. The altered regulation of Vascular Endothelial Grow~     Factor (VEGF) has been proposed as one of the principal factor in the pathogenesis of the~     ROP.~      The ROP is classified for: location (zones I,II,III), extension (hours 1 to 12) and for~     stages (1,2,3,4a,4b,5) and features of the vessels (normal, pre-plus and plus).~      With the diagnosis of ROP type 1(ROP zone I any stage with plus, zone I stage 3 without plus,~     zone II stage 2 y 3 with plus) the treatment is begun and ROP type 2 is maintained in~     observation.~      The altered regulation of Vascular Endothelial Grow Factor (VEGF) has been proposed as one of~     the principal factors in the pathogenesis of ROP.~   "
112871|NCT02090062|"~     Parts of patients are diagnosed as H. pylori -negative before ER, whereas the specimens~     become H. pylori-positive after ER, which may have a role in the recurrence of EGC. Our study~     aims to determine the difference in H. pylori infection rate of EGC patients before and after~     ER , and discuss the causes leading to the difference, which can provide references for~     improving the diagnostic accuracy of H. pylori infection and reducing EGC's recurrence rate.~   "
112872|NCT02090049|"~     The aim of this study is to evaluate the appetite rating of a soft bread with a high content~     of fibre and protein (Puravita Breakfast®) as well as its capacity to modulate postprandial~     levels of glucose, insulin and gastrointestinal hormones involved in appetite control and~     insulin secretion in healthy adult volunteers.~   "
112852|NCT02090309|"~     The investigators hypothesis is that low (or low relatively to the situation) cortisol levels~     might be a causative factor of whiplash injury or post traumatic stress disorder following~     road accidents. In this study the investigators enroll patients who sustained a road~     accident. From all patients a blood sample will be withdrawn to measure cortisol~     concentrations. Than, the patients will be divided into 2 groups: the study group will~     receive a single injection of intravenous Hydrocortisone 100 milligram (a synthetic steroid~     used routinely for many years). The control group will receive a same volume of normal saline~     which would be used as a placebo treatment. The investigators assume that patients with low~     cortisol levels would tend to have a higher incidence of whiplash injuries and / or post~     traumatic stress disorders, and that a single bolus of hydrocortisone may prevent these~     untoward sequelas of trauma.~   "
112853|NCT02090296|"~     Sickle cell anemia (SCA) patients experience organ damage that begins at an early age and~     results in significant morbidity and early mortality. Although all SCA patients share the~     same genetic mutation, the clinical complications are highly variable with some patients~     experiencing frequent and severe complications, while others have few serious complications.~     If SCA severity could be predicted early in life, those patients at greatest risk for~     complications could receive treatment prior to the onset of organ damage. No general SCA~     severity predictor or one that can be informative early in life exists. The investigators~     preliminary research has identified the absolute reticulocyte count (ARC) as a potential~     early predictive risk marker for SCA complications in pediatric patients. A higher ARC~     between ages 2 and 6 months of age is associated with an increased risk of hospitalization in~     the first 3 years of life; the mean ARC for the 36 patients who were hospitalized for SCA~     complications was significantly higher than that of the remaining 23 in those who were not~     hospitalized. Moreover, total hospitalizations were nearly three times higher by age 2 years~     in those infants who had an ARC of > 200 than for those infants whose ARC was <200. The~     proposed study will determine if ARC can be used as a risk-stratifier in asymptomatic infants~     with SCA and ascertain its value in targeting hydroxyurea therapy to those infants at highest~     risk of SCA sequelae.~   "
112854|NCT02090283|"~     The purpose of this study is to assess the continued safety of topical use of SD-101 cream~     (6%) in subjects with Epidermolysis Bullosa~      Funding-Source-FDA OOPD~   "
112855|NCT02090270|"~     The purpose of this study is to prospectively examine the relation between ischemic stroke~     and hair cortisol concentration. The investigators hypothesize that patients with ischemic~     stroke have higher levels of hair cortisol compared to controls.~   "
112856|NCT02090257|"~     The purpose of this pilot trial, Transitioning to Adult Care (TRANSIT), is to develop and~     test an intervention (i.e., a standardized, tailored transition program focused on enhancing~     adherence) to improve outcomes for emerging adults who underwent heart transplantation as~     children and transfer to adult care.~   "
112857|NCT02090244|"~     Parathyroid (PTH) hormone has been shown to enhance fracture healing in animal studies. There~     are so far only three published papers concerning humans. Postero-lateral fusions have shown~     a healing rate of less than 50% after bone. The purpose of this study is to determine if PTH~     1-34 (teriparatide) improves the healing rate and the clinical course after spinal stenosis~     surgery.~   "
112858|NCT02090231|"~     Dysphagia is one of severe complications among stroke survivors. Dysphagia is usually~     associated with high levels of morbidity, mortality, and financial cost. In recent years,~     repetitive transcranial magnetic stimulation (rTMS) has shown promise to facilitate~     poststroke dysphagia. However, most researches were preliminary studies in the past. The~     present study aims to investigate the immediate and long-term efficacy of high frequency rTMS~     on chronic dysphagic patients.~   "
112859|NCT02090218|"~     The main objective of this trial is to compare the effectiveness of a newer supraglottic~     airway method (the i-Gel), compared to current airway management practice in out-of-hospital~     cardiac arrests treated by Norwegian ambulance services.~   "
112860|NCT02090205|"~     Background There is no unanimous opinion about a lung-protective strategy in cardiac surgery.~     Small randomized clinical and animals trials suggest that ventilation during cardio-pulmonary~     bypass (CPB) could be protective on the lungs. This evidence is based on surrogate end-points~     and most of studies are limited to elective coronary surgery. According to the available~     data, an optimal strategy of lung protection during CPB cannot be recommended. The purpose of~     the CPBVENT study is to investigate the effectiveness of different ventilation strategies~     during CPB on post-operative pulmonary complications.~      Trial design The CPBVENT study will be a single-blind, multicenter, randomized controlled~     trial. We are going to enroll 780 patients undergoing elective cardiac surgery with planned~     use of CPB, aortic cross-clamping and two lung ventilation. Patients will be randomized into~     three treatment groups: 1) no ventilation during CPB; 2) continuous positive airway pressure~     (CPAP) with positive end-expiratory pressure (PEEP) of 5 cmH2O during CPB; 3) ventilation~     with 5 acts/minute with tidal volume of 2-3 ml/Kg and a PEEP of 3-5 cmH2O during CPB. The~     primary end-point will be the incidence of a PaO2/FiO2 ratio <200 until the time of discharge~     from the ICU. The secondary end-points will be the incidence of post-operative pulmonary~     complications and 30-days mortality. Patients will be followed-up to 12 months after the date~     of randomization.~      Summary The CPBVENT Trial will determine whether different ventilation strategies during CPB~     will improve pulmonary outcome in patients undergoing cardiac surgery.~   "
112873|NCT02090036|"~     The purpose of this study is to assess efficacy and safety of a single low-dose Primaquine~     added to standard artemether/lumefantrine treatment for the clearance of Plasmodium~     falciparum gametocytes among patients with uncomplicated malaria aged 1 year and above~     regardless of their G6PD status.~   "
112874|NCT02090023|"~     The purpose of this study is to explore long-term prognosis and to identify the predictors in~     Taiwanese OSA patients. Validation of the prediction model derived from NHIRD with the~     database of National Taiwan University Hospital (NTUH) sleep center is planed to determine~     the effects of different treatments on long-term prognosis.~   "
112875|NCT02090010|"~     Seldinger technique is a minimally invasive technique in which the practitioner accesses the~     target vessel with a small bore needle, then dilates to the size required for the catheter.~     Contrarily, modified Seldinger technique(guiding sheath-over-the-needle technique) use needle~     that is covered with guiding sheath.~      Both technique is widely used in central venous catheterization, however, few researches have~     been investigated to compare success rate or complications of both methods.~   "
112861|NCT02090192|"~     Objective: To study the acute and chronic effects of whole-body vibration (WBV) exercises on~     the lower extremity blood flow, mobility function, balance, muscle strength, bone density,~     and general health status, and its feasibility as an intervention in frail elderly patients.~      Design: Randomized controlled trial. Subjects: The frail older persons meeting the Fried~     Frailty Criteria.~      Interventions: All eligible subjects were randomly assigned to 4 groups:~      (1) WBV group: Subjects received a whole-body vibration exercise alone; (2) Progressive~     resistance training (PRT) group: Subjects received progressive resistance training; (3) WBV+~     PRT group: Subjects received the whole-body vibration and progressive resistance training;~     (4) Control group: Subjects received no intervention/training. The periods of intervention~     are 12 weeks.~      Main measures: The lower extremities blood flow (the diameters and red blood cell velocity of~     the common femoral artery), timed up and go test, 30-second chair stand test, five times sit~     to stand test, lower extremities muscle strength, balance function, balance confidence, bone~     density, and general health status was assessed at the beginning of the study, at instant, 12~     weeks and 24 month after the intervention.~      Study hypothesis: Whole-body vibration exercise is a safe and effective method that can~     improve the lower extremity blood flow, mobility function, balance, muscle strength, bone~     density, and general health status in the frail elderly.~   "
112862|NCT02090179|"~     The purpose of the study is to characterize structural abnormalities in the brain and the~     integrity of the blood brain barrier in patients with mucopolysaccharidosis type IIIB (MPS~     IIIB).~   "
112863|NCT02090166|"~     Purpose: To evaluate the performance of Extracellular Monitoring of Metabolic Activity~     Profiles of Peripheral Blood Mononuclear Cells (PBMC) analysis method in identifying lung~     cancer.~      The study population will include a total of 950 participants, patients with lung cancer~     before any treatment, and healthy and COPD patients as a control group.~   "
112864|NCT02090153|"~     The purpose of this study is to evaluate the effectiveness and safety of S-1 plus Leucovorin~     (1 week on and 1 week off) as first-line treatment for patients with metastatic and recurrent~     gastric cancer.~   "
112865|NCT02090140|"~     The purpose of this study is to compare two biologic methods for the treatment of articular~     cartilage defects in the knee. The first method, microfracture, is the standard of care and~     is routinely used to recruit cells from the subchondral bone marrow to the site of cartilage~     loss. The second method is the application of adipose-derived stem cells (ADSCs) to the~     defect site. In theory, ADSCs on a collagen scaffold should enable the delivery of more~     specific progenitor cells to the site of injury, resulting in better regeneration and~     integration of articular cartilage at the site of a defect as compared to the microfracture~     method.~   "
112866|NCT02090127|"~     Protocol to Allow Continued Access of Ficlatuzumab to P05538 Patient~   "
112867|NCT02090114|"~     Single-arm, single site, open label study of the effects of parenteral testosterone followed~     by enzalutamide or abiraterone or castration-only therapy in men with metastatic CRPC who~     previously progressed on one of these forms of therapy. The study will enroll three cohorts~     of patients: men with metastatic CRPC who have progressed on enzalutamide (Cohort A); men~     with metastatic CRPC who have progressed on abiraterone acetate (Cohort B); and men with~     metastatic CRPC who have progressed on first line castration-only therapy (Cohort C).~   "
112868|NCT02090101|"~     The metastatic colon cancer is a major public health problem despite advances in~     chemotherapy; few new drugs are in development for the treatment of this pathology.~      Many studies have shown that human colon cancer is a tumor that is recognized by the immune~     system and the presence of lymphocytic infiltrates in the tumor bed is associated with a~     better prognosis. Conversely, the effect of chemotherapy on the immune response is little~     studied.~      Recently the importance of myeloid suppressor cells (MDSC) in the development of colon cancer~     and the effect of 5- fluorouracil on this cell population has been highlighted. An~     accumulation of these cells in the blood and lymphoid organs during tumor progression is~     observed. Moreover, it has been established that the death of MDSC induced by 5-fluorouracil~     induces activation of caspase -1 and IL-1beta by these MDSC.~      These events promote the polarization of CD4 T cells in intratumoral Th17 lymphocytes. The~     IL- 17 produced by these cells exerts a pro-angiogenic effect in inducing proliferation of~     endothelial cells expressing and thus limits the effect of 5- fluorouracil endoglin.~      In humans, it has also been observed that chemotherapy using 5- fluorouracil and in~     particular LV5FU2 association +/- bevacizumab induces rapid death of blood MDSC as well as~     activation of caspase 1 in these cells. Thus, production of IL - 1 is detected in the serum~     of patients after 24 hours of the administration of 5-fluorouracil.~      Chronic inflammation and the production of interleukin- 1 can alter the effectiveness of anti~     -tumor immune responses and facilitate angiogenesis. Many preclinical data suggest a role of~     anti -tumor inhibition of IL- 1beta, but the effect of a combination of chemotherapy and an~     inhibitor of IL - 1beta has not yet been tested in human.~      Anakinra is a drug used in humans for many years to treat signs and symptoms of rheumatoid~     arthritis. In combination with methotrexate, in patients whose response to methotrexate alone~     is not satisfactory it had shown interesting results. The dose used clinically is 100 mg per~     day which is the dose that is proposed to be tested in this study.~      In this context it should be remembered that methotrexate is a chemotherapeutic agent from~     the class of antimetabolites such as 5- fluorouracil.~      RCP of this drug indicate that in studies originator toxicity was similar between the control~     arm and anakinra arm with an increase in serious infections (1.8 % vs 0.7 %) and an increased~     incidence of neutropenia (2.5 % neutropenia > grade = 1). The main toxicity observed is a~     painful inflammatory reaction at the injection site in 70 % of patients The investigators~     believe that this project could permit to validate in man preclinical observations showing an~     anti-tumor potential for combination anakinra and 5 fluorouracil.~   "
112869|NCT02090088|"~     US study to estimate the prevalence at birth of major birth defects (ie, those that cause~     significant functional or cosmetic impairment, require surgery, or are life-limiting) in~     children born to mothers who have received Nplate® therapy at any time during the pregnancy.~   "
112870|NCT02090075|"~     Vitamin K-antagonists (VKA) such as warfarin are the most widely used blood thinners for~     irregular heart beats like atrial fibrillation. Several lines of evidence indicate, however,~     that these agents also cause calcification of vessels (hardening of the vessels). Vascular~     calcification is one of the recently revealed side-effects of warfarin therapy. We will be~     randomizing 66 patients to either take warfarin or a new blood thinner that works without~     affecting vitamin k (apixaban). Patients will undergo blood testing and a CT angiogram~     (non-invasive angiogram) at the beginning of the study, and then be followed for one year~     with quarterly visits including blood tests and given either warfarin or vitamin K. After one~     year, they will undergo another CT angiogram and examination and blood tests and the effect~     of apixaban and warfarin are tested to look at plaque and changes over time. Patients will be~     consented in a private room and the risks and benefits will be explained. The risks include~     the CT angiogram and the possibility of either remaining on warfarin therapy for another year~     (standard of care) or taking a medicine that doesn't require monitoring (apixaban) for one~     year. The CT angiograms will require some contrast and some radiation dose, which will be~     minimized as much as possible. A cardiologist will be present during each CT angiogram to~     minimize risk and ensure patient safety.~   "
113071|NCT02087449|"~     Evaluate E1 wear, Clinical Performance of E1 liner in THA in Korean Patient Population~   "
112876|NCT02089997|"~     The purpose of this study is to evaluate the safety and efficacy of sodium risedronate~     tablets (Benet 75 mg Tablets) in osteoporosis patients in daily medical practice, as well as~     to examine the status of treatment compliance - i.e., whether sodium risedronate tablets~     are taken properly in accordance with the prescribed once-monthly regimen~   "
112877|NCT02089984|"~     Anxiety disorders are a major public health concern, having a profound impact on functioning,~     causing significant disability, loss of productivity and suffering. Effective treatments~     exist for these disorders, but few clinicians are trained in these methods. This project~     attempts to remedy this shortcoming by using web-based tools to facilitate access to this~     training, thus increasing the number of available therapists in order to help meet this unmet~     need.~   "
112878|NCT02089971|"~     To describe the normal range of muscle mass and function in Chinese adults.~   "
112879|NCT02089958|"~     Incisional hernias are one of the most frequent complications in abdominal surgery.~     Laparoscopic repair is widely used but even not standardized. Existing data from different~     study designs show no representative data resulting in a lack of comparability and evidence.~     Therefore the standardization of operative techique has been proposed by the LIPOM-study~     group and will be assessed in a prospective manner.~   "
112880|NCT02089945|"~     Narrowing of the aortic valve in the heart, known as severe aortic stenosis, can impede blood~     delivery and is associated with poor quality of life and death. In the elderly with~     considerable medical burden, a relatively new non-invasive valve replacement technique called~     Transcatheter Aortic Valve Implantation (TAVI) can be used instead of open-heart surgery.~     However, long term changes in cognition after TAVI remain unclear and previous studies have~     suggested an increased risk of cognitive decline in patients following the surgical~     procedure. In this pilot study, the investigators will characterize changes in cognition,~     physical capacity, overall quality of life and neuropsychiatric symptoms (depression and~     apathy) over 6 months after TAVI.~   "
112881|NCT02089932|"~     The duration of sensory block after single dose of long acting local anesthetics is not~     sufficient to avoid the postoperative use of opioids. Alpha-2 adrenoceptor agonists such as~     clonidine have been shown to increase the duration of peripheral nerve block. Dexmedetomidine~     is a more potent and selective α-2-adrenoceptor compared to clonidine. To the best of our~     knowledge, the use of Dexmedetomidine in different dose levels as adjuvant to local~     anesthetic was not previously reported for femoral nerve block.~   "
112882|NCT02089919|"~     Most studies of cancer stem cells (CSC) involve the inoculation of cells from human tumors~     into immunosuppressed mice, preventing an assessment on the immunologic interactions and~     effects of CSCs. In this study, the investigators examined the vaccination effects produced~     by CSC-enriched populations from histologically distinct murine tumors after their~     inoculation into different syngeneic immunocompetent hosts. Enriched CSCs were immunogenic~     and more effective as an antigen source than unselected tumor cells in inducing protective~     antitumor immunity.Immune sera from CSC-vaccinated hosts contained high levels of IgG which~     bound to CSCs, resulting in CSC lysis in the presence of complement.CTLs generated from~     peripheral blood mononuclear cells or splenocytes harvested from CSC-vaccinated hosts were~     capable of killing CSCs in vitro. Mechanistic investigations established that CSC-primed~     antibodies and T cells were capable of selective targeting CSCs and conferring anti-tumor~     immunity.~   "
112883|NCT02089906|"~     This study is aiming to understand the prevalence and risk factors related to malnutrition~     and sarcopenia in Chinese elderly.~   "
112884|NCT02089893|"~     The purpose of this study is to analyze the retinal arteries, to investigate the incidence,~     number, types, distribution and localization of cilioretinal arteries in the Hungarian~     Caucasian population.~   "
112885|NCT02089880|"~     The study will specifically evaluate the potential of the C-Brace to improve the functional~     mobility and quality of life in individuals with lower extremity impairments due to~     neurologic or neuromuscular disease, orthopedic disease or trauma, as compared to the stance~     control orthosis.~   "
112886|NCT02089867|"~     The purpose of this study is to determine the effect of plant sterols associated with~     ezetimibe in LDL-cholesterol levels in coronary patients previously on statin therapy~   "
112887|NCT02089854|"~     The study is a prospective multi-center randomized control clinical trial which is sponsored~     by the researchers. The purpose of this study is to determine the effectiveness of adjuvant~     endocrine therapy for operable ER-beta positive, ER-alpha/PR negative, Her-2 negative breast~     cancer(triple negative breast cancer, TNBC) patients. The ER-beta positive TNBC patients who~     had undergone modified radical mastectomy or breast-conserving surgery were randomly (1:1)~     enrolled to receive toremifene (60 mg per day for premenopausal and perimenopausal patients)~     /anastrozole(1mg per day for postmenopausal patients) or observation within 4 weeks after~     adjuvant chemotherapy and/or radiation therapy if necessary.The follow-up time will be at~     least five years. The disease free survival(DFS) and overall survival(OS) between endocrine~     group and observation group will be compared to evaluate the effectiveness.~   "
112888|NCT02089841|"~     Artemether-lumefantrine has been used in Tanzania as first-line treatment for uncomplicated~     malaria since 2007. Nonetheless, a report of increased proportion of patients with~     parasitaemia on day 1 following treatment with artemisinin based combination therapies has~     emerged from Kenya. Similarly, resistance against artemisinins has been confirmed in~     South-East Asia and it can spread to Africa. Therefore, the purpose of this study was to~     assess the efficacy of Artemether-lumefantrine for the treatment of uncomplicated malaria~     among children after five years of wide scale use of the drug in Tanzania.~   "
112889|NCT02089828|"~     To compare the efficacy and cost-effectiveness between purified CD34+ cells and peripheral~     blood mononuclear cells in treatment of critical limb ischemia~   "
112909|NCT02089555|"~     African Americans are twice as likely to develop Alzheimer's disease as white Americans, but~     few African Americans are enrolled in large Alzheimer's biomarker studies. The current~     proposal aims to determine the influence of Alzheimer's disease and vascular disease on~     memory and aging in African Americans through modern biomarkers (spinal fluid, MRI, and~     amyloid imaging), and how these may differ between African Americans and white Americans in~     preparation for a large multi-center study of aging in African American.~   "
113072|NCT02087436|"~     The primary purpose of this study is to measure the postoperative changes in bone mineral~     density, comparing the Taperloc Complete Reduced Distal Microplasty stem and the standard~     length Taperloc Complete Reduced Distal stem.~   "
112890|NCT02089815|"~     Prior studies have shown multifaceted falls prevention program with home-based exercise~     reduced falls significantly in the community setting. The Otago exercise program has been~     tested in four separated controlled trials of community living people in New Zealand. Falls~     were the main outcome in each trail and were defined as unintentionally coming to rest on~     the ground, floor or other lower level. Not only this combination strengthening and balance~     training exercise could reduce fall but also could benefit in cost-effectiveness for fall~     prevention and decrease mortality in those 80 and older. However the limitation of Otago~     exercise program is that the program was needed to be trained by skill nurses or physical~     therapists. There are 17 steps levels to adhere the program. As some studies have shown that~     fall prevention program adherence could be as low as 10-40%. In Thailand the lack of medical~     staffs are continued the problem in the community. Therefore to establish fall prevention~     guideline that will be suitable and translated into the real setting, this study is aimed to~     test the effectiveness of simple program home-based exercise comparing to non-simple program~     home based exercise in preventing fall and improve muscle strength and balance dysfunction in~     older people with mild to moderate balance dysfunction. The method is the randomized~     controlled trails.~   "
112891|NCT02089802|"~     Optimization of Pazopanib Exposition in Patients with Renal Cell Carcinoma by Therapeutic~     Drug Monitoring followed by Individual Dose Escalation.~   "
112892|NCT02089789|"~     Background:~      - Proteins, fats, and other molecules are the body s building blocks. Many of these molecules~     must have sugars, or chains of sugars, attached to work properly. People with congenital~     disorders of glycosylation (CDGs) cannot attach these sugars or sugar chains properly. A~     child or adult with a CDG can have symptoms in different parts of the body, including brain,~     nerves, muscles, liver, and immune system. Researchers want to learn more about these~     diseases to understand better what is causing the problems.~      Objective:~      - To learn more about CDGs.~      Eligibility:~      - People age 1-80 with CDG or suspected to have a CDG.~      Design:~        -  CDG participants will stay in the hospital 3-5 days. They will have:~        -  Medical history and physical exam. They will answer questions about their CDG.~        -  Blood taken several times. Their skin will be numbed, then a needle will take blood from~          an arm vein.~        -  Samples taken of their skin, urine, and maybe stool and spinal fluid.~        -  Photos taken of their whole body. They can wear underwear and cover their eyes.~        -  Brain MRI. They will lie on a table that slides in and out of a metal cylinder. The~          scanner makes loud knocking noises so they can wear earplugs.~        -  Abdomen ultrasound. Sound waves take images of the body from the outside.~        -  Hand/wrist X-rays for young patients. They may have a full-body X-ray.~        -  DEXA bone density scan. Participants will lie on a table under a scanner.~        -  Echocardiogram and electrocardiogram for heart activity. Pads are stuck on the skin and~          the electrical activity of the heart is recorded.~        -  Tests of hearing, thinking, motor skills, and speech.~        -  Children participants may have tests done under sedation if it will benefit them~          directly.~        -  CDG participants may have other procedures during their visit. They may have follow-up~          visits every year.~   "
112893|NCT02089776|"~     Background:~      - People can learn to use feedback about brain activity to change that activity. Researchers~     want to see if people who have had a stroke can change their brain activity by practice and~     thought with feedback, and if that improves motor control. They will study brain activity in~     people who have and have not had strokes.~      Objectives:~      - To see if people with stroke can change their brain activity and improve motor control by~     practice and thought.~      Eligibility:~        -  Adults 18 80 years old who have had a stroke.~        -  Healthy volunteers 18 80 years old.~      Design:~        -  Participants will be screened with a medical history, MRI, and physical exam. For MRI, a~          magnetic field and radio waves take pictures of the brain. Participants lie on a table~          that slides in and out of a cylinder. They will be in the scanner less than 2 hours,~          lying still for up to 15 minutes at a time. The scanner makes loud noises. Participants~          will get earplugs.~        -  Participants will have up to 3 scanning visits and up to 3 follow-up visits within 24~          weeks. Visits may include screening, MRI, functional MRI (fMRI), questionnaires, and~          simple motor tests. Stroke participants may take additional motor tests, including~          transcranial magnetic stimulation (TMS).~        -  fMRI: During this MRI, small metal disks may be taped to the skin or a fabric glove with~          small wires in it may be used to monitor hand movements. Heart rate and breathing may~          also be monitored. Participants may be monitored by video and asked to perform tasks.~        -  TMS: A brief electrical current goes through a coil on the scalp. It creates a magnetic~          pulse that stimulates the brain. Participants may be asked to perform simple actions.~          Finger or hand movements may be recorded.~   "
112894|NCT02089763|"~     The purpose of the study is to evaluate the efficacy and safety of PEG-BCT-100 as the~     second-line therapy following sorafenib in advanced HCC patients. Another objective of the~     study is to explore whether the expression of OTC and ASS are predictive biomarkers for drug~     response and prognosis.~   "
112895|NCT02089750|"~     The goal of this randomized clinical study is to assess pain and dysfunction in 225 volunteer~     subjects who have chronic low back pain.~      The hypothesis of this study is that custom-made shoe will improve patients' low back pain~     and dysfunction. Additionally, custom-made shoe orthotics plus chiropractic treatment will~     further improve patients' low back pain and dysfunction while maintaining that improvement~     during the one year study follow-up period.~      Specific Aims:~        1. To determine the changes in perceived pain levels (Numeric Pain Rating Scale) and~          dysfunction (Oswestry Disability Index) in patients with chronic low back pain after six~          weeks of custom-made shoe orthotic use with or without chiropractic care as compared to~          no care.~        2. To determine the changes in perceived pain levels and dysfunction in patients with~          chronic low back pain after twelve weeks of custom-made shoe orthotic use.~        3. To determine the changes in perceived pain levels and dysfunction at 3, 6, and 12 months~          following the 12 week treatment period.~   "
112896|NCT02089737|"~     The efficacy and safety of panitumumab (Vectibix) in the routine clinical setting will be~     studied.~      Specifically, information will be collected on the following as events of interest: skin~     disorders, interstitial lung disease, infusion reactions, electrolyte abnormalities, and~     cardiac disorders.~   "
112924|NCT02089360|"~     Blood sample is prospectively taken from consecutive patients underwent coronary angiogram in~     our center, after getting informed consent from the patients. Serum level of advanced~     glycation end products (AGEs) was measured and the clinical features of patients (including~     angiographic results) were entered into our database. Clinical follow-up was performed for~     all patients, and the relationship between AGEs and paitents' outcome were analyzed. Further~     intervention will be adjusted according to the results,including clinical and basic research~     in lab.~   "
113073|NCT02087423|"~     A study to assess the Effects of MEDI4736 (Durvalumab) in Patients With Locally Advanced or~     Metastatic Non Small Cell Lung Cancer in terms of efficacy, safety and tolerability~   "
112897|NCT02089724|"~     Erdheim-Chester disease (ECD) is a rare non-Langerhans cell histiocytosis. Diagnosis of ECD~     is based on clinical symptoms, imaging and histology with infiltration of tissues by foamy~     CD68 positive CD1a negative histiocytes.~      Because half of the ECD patients carry a BRAFV600E mutation, we recently proposed~     vemurafenib, an inhibitor of mutant BRAF, as a possible targeted therapy. We have treated~     more than10 patients with refractory ECD with life-threatening manifestations associated with~     the BRAFV600E mutation and observed a short and long term efficacy.~      However, vemurafenib may have several side effects and long term administration of this drug~     has not been evaluated. In other diseases such as melanoma, duration of administration is~     usually shorter, due to bad prognosis of the disease and progression despite treatment.~      As in long-term follow-up, ECD patients with vemurafenib seem to have a stable disease, we~     want to evaluate the possibility of treatment interruption as this is what we do in our~     current practice. Other BRAF inhibitors, such as dabrafenib, have recently been proposed for~     treating BRAF mutated histiocytoses. Other BRAF inhibitor interruption treatment should also~     be prospectively evaluated.~   "
112898|NCT02089711|"~     This study is being initiated to create a normal database including measures of optic nerve~     head (ONH), peripapillary retinal nerve fiber layer (RNFL), and macula using the Heidelberg~     Spectralis OCT device. The range will be determined for each structural parameter across~     normal eyes in Japanese subjects, and the measurements stratified according to age.~   "
112899|NCT02089698|"~     To compare the efficiency of surgical procedures using 2 phaco tip designs in torsional~     phacoemulsification using the bevel-down technique.~   "
112900|NCT02089685|"~     This study is being done to analyze the safety, tolerability, and efficacy of treatment for~     advanced melanoma (MEL) and renal cell carcinoma (RCC) using combination regimens of~     pembrolizumab + pegylated interferon alfa-2b (PegIFN-2b) and pembrolizumab + ipilimumab~     (IPI). The primary hypothesis is that these combinations will be sufficiently well-tolerated~     to permit continued clinical investigation.~   "
112901|NCT02089672|"~     Abnormal heart rhythms or arrhythmias are often managed by a procedure in which a catheter is~     introduced into the heart. These catheters can then cauterize abnormally functioning portions~     of the heart muscle with the hope of returning the heart to a more effective rhythm. In the~     process of performing such a procedure, called a catheter ablation, an operator must be able~     to accurately sense electrical activity displayed on computer screens in different parts of~     the heart, provide sufficient localized energy to the abnormally behaving tissue (ideally~     without damaging uninvolved heart structures), and accurately reassess the electrical~     activity of the heart to ensure the spot in the heart has been cauterized.~      When sensing electrical activity of the heart, specialized catheters produce recordings on a~     computer screen known as electrograms (EGM). To produce this recording conventional catheters~     commonly use a positive and negative electrode, from which the difference between the two~     provides the EGM. The distance between the two electrodes varies from device to device. The~     greater the distance between them, the less accurate the measurement of local electrical~     activity becomes. This may result in poorly localized or excessive use of energy that could~     be damaging to normal heart structures or put the patient at risk for the return or~     development of additional arrhythmias. The IntellaTip MiFi catheter has been constructed with~     a specialized sensing tip that uses microelectrodes that are relatively close in proximity~     (<1 mm apart) with the hope of improving the sensing capability of the device.~      This study will analyze the signals obtained from this FDA-approved catheter in people~     undergoing a catheter ablation procedure. The study will examine signals after the procedure~     is finished and will not prolong or differ the process from a standard ablation procedure.~     The goal of this study is to determine the ability of the microelectrodes to distinguish~     ablated, or cauterized versus non-cauterized tissue.~   "
112902|NCT02089659|"~     This study will investigate the influence of hepatic insufficiency on the pharmacokinetics~     (PK) of doravirine (MK-1439). In Part 1, PK of doravirine in participants with moderate~     hepatic insufficiency will be compared with that of healthy control subjects matched with~     regard to mean age and weight. If a clinically meaningful increase in doravirine exposure is~     observed in participants with moderate hepatic insufficiency in Part 1, study Part 2 will~     evaluate PK of doravirine in participants with mild hepatic insufficiency.~   "
112903|NCT02089633|"~     The propose of the study is to evaluate the maximum tolerated dose (MTD) of Oxaliplatin in~     combination with pegylated recombinant human arginase 1 (PEG-BCT-100) and Capecitabine and~     efficacy of this combination regimen (PACOX)in patients with advanced liver cancer.~   "
112904|NCT02089620|"~     Premenstrual syndrome represents a group of problems affecting most of women in reproductive~     age. These problems include emotional and physical symptoms. In this study the efficacy of~     oral contraceptive pills and calcium supplements in relieving these symptoms will be assessed~     .~   "
112905|NCT02089607|"~     Subjects for this study will have been diagnosed with a bulge or aneurysm in their abdominal~     aorta, which is the blood vessel in the abdomen (belly) that supplies blood to most of the~     lower body including major organs and the legs.~      The purpose of this study is to gather safety and effectiveness of the Zenith t-Branch and~     customized physician-specified stent-graft with a combination of fenestrations and/or~     branches to repair the aneurysm.~      The Zenith t-Branch and physician-specified fenestrated and branched endovascular graft is a~     tubular graft made of polyester fabric sewn to stainless steel stents that keep the graft~     open. As an aneurysm expands, the walls become weak and may rupture, causing a major loss of~     blood with a high risk of death and other serious complications. To avoid this risk the~     aneurysm will be repaired by putting a graft in place of the aneurysm. The graft will be~     inserted through arteries in the leg (called endovascular repair). This procedure uses~     catheters that go inside the blood vessel to place a stent graft above and below the~     aneurysm.~      The upper portion of the graft includes 1 to 5 small holes (fenestrations) or cuffs (side~     branches) that allow the graft to be located above the renal arteries without blocking blood~     flow to them. These small holes or branches are the investigational part of this research~     study. This is needed when there is not enough healthy aorta below the renal arteries. At~     least one artery may also be treated with an alignment stent (small tubular stainless steel~     structures) to help keep the arteries open and aligned with the fenestrations or branches.~     The Zenith t-Branch and physician-specified fenestrated and branched endovascular graft will~     be referred to as the Zenith Fenestrated-Branched System.~   "
112906|NCT02089594|"~     Objective/Hypothesis: An eight-week course of forty low-pressure Hyperbaric Oxygen~     Treatment's (HBOT's) can significantly improve symptoms and cognitive function in subjects~     with the persistent-post concussion syndrome (PPCS) of mild traumatic brain injury (mTBI).~   "
112907|NCT02089581|"~     To determine whether two new oral formulations of a strong pain killer release the drug into~     the body in a similar pattern as the already marketed reference capsule formulation with or~     without food.~   "
112908|NCT02089568|"~     The aim of this study is to see whether antibiotics given at the start of laparoscopic kidney~     donation surgery prevent infection.~   "
113074|NCT02087410|"~     measuring serum gherlin in polycystic ovary syndrome patients and compare it to healthy~     levels~   "
112910|NCT02089542|"~     Reliable identification of parathyroid glands is critical to the success of thyroid and~     parathyroid surgery. In thyroid surgery, inadvertent injury to parathyroid glands may cause~     temporary or permanent hypoparathyroidism (low calcium levels needing long term treatment).~     In parathyroid surgery, early identification of normal and/or enlarged parathyroid glands~     helps in deciding on the extent of surgery and increases the chances of postoperative normal~     calcium levels.~      Methylene Blue (Methylthioninium chloride, MB) is a dye that when given intravenously in high~     doses, is taken up differently by thyroid and parathyroid tissue. It is currently used during~     parathyroid surgery by some surgeons to help identify enlarged parathyroid glands by visual~     examination alone. Such visual examination is unhelpful in the identification of 'normal'~     parathyroid tissue. MB exhibits fluorescent properties in the near-infrared range (light just~     beyond the visible spectrum). This can be picked up by an appropriate imaging system. This~     has potential to identify and differentiate between 'normal' parathyroid, 'abnormal'~     parathyroid and thyroid tissue during surgery.~      The investigators have established the feasibility of the intra-operative use of a near~     infra-red fluorescent imaging device called Fluobeam® and demonstrated the ability of this~     device to pick up near infra-red fluorescence from human tissue after administration of~     intravenous MB. Animal experiments have shown that doses as low as 0.1mg/kg of MB given~     intravenously enable fluorescent visualisation of thyroid and parathyroid glands.~      This study will aim to optimise the dose and timing of administration of MB in human thyroid~     and parathyroid surgery and to develop a protocol which would then subsequently be assessed~     for effectiveness in a multi-centred randomized controlled setting.~   "
112911|NCT02089529|"~     The following study investigates the role of information/expectancies in the response to~     Ibumetin and placebo.~      The study is a double-blind randomized controlled trial with crossover, within subjects~     repeated measurements. The symptoms are measured by questionnaires. 40 patients will be~     included in the study. The administrated drug is Ibumetin 400 mg.~      The study does not require patients to meet in the clinic. Patients will be instructed in how~     to report pain, tension and nervousness via mobile phone (Checkware AS, Trondheim,~     Norway).Three days a week for 12 weeks the patients are instructed to report at 0900 AM, and~     thereafter at 0910, 1100, 1300, 1500, 1700, and 1900 hrs each study day. At these times the~     patients will receive a sms where they are instructed to immediately rate their pain and~     stress level and report back.~   "
112912|NCT02089516|"~     The purpose of this stuydy is to assess the bias and repeatability of the DynaPort MicroMod~     in measuring movement / physical activity in frail elderly.~   "
112913|NCT02089503|"~     Main Objective: The main objective of this retrospective observational study was to describe~     the evolution of visual acuity measured on ETDRS (Early Treatment Diabetic Retinopathy Study)~     scale, for patients with exudative Age-Related Macular Degeneration (ARMD), treated with~     Lucentis, under real conditions of care, in terms of mean change of the Best Corrected Visual~     Acuity (BCVA), measured at 24 months (± 4 weeks).~   "
112914|NCT02089490|"~     The dermal substitute NEVELIA® has received CE marking in July 9, 2013. Its use in the NEVAL~     protocol will be in accordance with its leaflet, i.e. for the treatment of burns or in case~     of reconstructive plastic surgery.~      The matric implantation will be followed by autologous skin grafting when the neodermis~     formation will be observed.~   "
112915|NCT02089477|"~     Low physical fitness may cause several life style related diseases e.g. cardiovascular~     disease, cancer and type 2 diabetes. It is important to develop reliable methods for~     measurement which can be used to follow the development of the physical shape both on an~     individual level and on at population level.~      Associated with the development of new training method known as Interval Walking we developed~     an application for smartphones. The use of the application InterWalk was meant to increase~     physical activity in patients with type 2 diabetes. The application should both be able to,~     1) be a personal trainer when doing interval walking, and 2) measure the individual physical~     fitness performed as a walking test. The latter function was developed to make the training~     more personal and individal adapted, so that the training was neither too hard or too easy.~      It is necessary to test the walking test against a golden standard for measuring physical~     fitness and that the test in the application is able to measure and register changes in~     physical fitness.~      Our hypothesis is that the individual test, in the InterWalk Application is reliable and able~     to register changes in physical fitness in patients with type 2 diabetes. The purpose of this~     project is investigate the reliability of a smartphone-based test of physical fitness, and to~     investigate whether the test is able to register changes in physical fitness during the~     project time (3 month). A secondary aim is to investigate whether individual support during~     the training period, affect the individual effort and time of interval walking per week.~   "
112916|NCT02089464|"~     A pivotal, prospective, multi-center, randomized, controlled, double-blinded study combining~     active Nexstim NBS-guided 1Hz rTMS or sham-rTMS targeting the healthy hemisphere with~     standardized task oriented rehabilitation will be conducted in patients with post-stroke~     motor impairment. The therapy will be provided for 6 weeks and primary outcome assessed 6~     months later.~   "
112917|NCT02089451|"~     This trial is conducted in Europe. The aim of the trial is to compare the pharmacokinetic~     properties (the exposure of the trial drug in the body) of faster-acting insulin aspart~     (FIAsp) after different injection regions and routes of administration in healthy subjects.~   "
112918|NCT02089438|"~     Hypothesis is that DPP-4 inhibition affects glucose levels through changes in incretin and~     islet hormones. The study examines this in relation to breakfast, lunch and dinner over an~     entire 24h study period by the use of three different DPP-4 inhibitors and placebo.~   "
112919|NCT02089425|"~     This is a randomized, double blind, placebo controlled, parallel group study to assess the~     efficacy and safety of K-103-IP compared with placebo patch for treatment of mild to moderate~     acute pain associated with ankle strain or sprain.~   "
112920|NCT02089412|"~     This is an open-label, single-dose, randomized crossover study of single oral 10-mg tablet~     doses administered either after an overnight fast or in combination with a standard high-fat~     meal in healthy subjects.~   "
112921|NCT02089399|"~     The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug~     interaction between amlodipine, olmesartan and rosuvastatin in healthy adult volunteers.~   "
112922|NCT02089386|"~     Treat Barrett's esophagus (BE) patients with tamoxifen to Barrett's metaplasia as measured by~     changes in Barrett's esophagus appearance by endoscopy and histology as well as changes in~     SOX2 and CDX2.~   "
112923|NCT02089373|"~     The purpose of this study is to conduct a study on genetic pathology, obtaining of pure~     cancer tissues is mandatory. Although the endoscopy with biopsy has been a gold standard for~     diagnosing gastric cancer, percentage of cancer cells in biopsy samples is usually 30% or~     less. Recently, confocal laser endomicroscopy has been introduced for real-time~     histopathologic diagnosis in various cancers. The investigators aim to evaluate that biopsy~     using probe-based confocal laser endomicroscopy will increase the percentage of cancer cells~     in biopsy samples.~   "
112925|NCT02089347|"~     The aim of the study is to generate additional safety and immunogenicity data to support the~     registration of the product in Japan.~      Primary objectives:~        -  To demonstrate the non-inferiority of SP306 versus DT (DT 0.1mL) vaccine in terms of~          diphtheria and tetanus booster response rate (proportion of subjects with booster~          responses) and seroprotection rate (percentage of subjects with antitoxin concentrations~          ≥0.1 IU/mL) at 28 days (window 28-35 days) after one injection in Japanese adolescents~          11-12 years of age.~        -  To evaluate the immune response of SP306 against the pertussis antigens PT and FHA in~          terms of booster response rate (proportion of subjects with booster responses) at 28~          days (window 28-35 days) after one injection in Japanese adolescents 11-12 years of age.~      Secondary objectives:~        -  To further evaluate the immune response of the study vaccines against diphtheria,~          tetanus and pertussis antigens.~        -  To assess the safety of the study vaccines after one injection in Japanese adolescents~          11-12 years of age.~   "
112926|NCT02089334|"~     The purpose of this study is to determine the maximum tolerated dose of RX-0201, up to a~     target dose of 250 mg/m^2/day, when given in combination with everolimus (Stage 1), and to~     assess the safety and efficacy of RX-0201 plus everolimus, in subjects with metastatic renal~     cell cancer (Stage 2).~   "
112927|NCT02089321|"~     The purpose of this study was to investigate whether combined assessment of lumbopelvic~     control during sagittal and frontal plane motion (using two common clinical observational~     assessments) discriminates between people with and without LBP than single plane assessment~     alone. It was hypothesized that the two tests used in combination (multiplanar) would perform~     better than each test used independently (single planar) in accurately discriminating patient~     cases from healthy controls.~   "
112928|NCT02089308|"~     The purpose of this study is to evaluate the bioequivalence of a new transdermal nicotine~     patch to that of a reference formulation following repeated applications~   "
112929|NCT02089295|"~     To evaluate the dose proportionality of 5 mg, 20 mg and 40 mg of PF 00345439 formulation~     under fed conditions in healthy volunteers.~   "
112930|NCT02089282|"~     In an attempt to answer if clavicular length changes after a fracture e.g. that any~     shortening becomes worse or better, 70 patients will be followed 3 times over 21 days using a~     novel ultrasound method.~   "
112931|NCT02089269|"~     The registry aims to collect and analyse information on the antineoplastic treatment of~     patients with unresectable locally advanced or metastatic pancreatic cancer, treated in~     palliative intention (cohort 1) and patients with localized, resectable pancreatic cancer~     treated in neo-adjuvant or adjuvant intention (cohort 2) in daily routine practice in~     Germany. The registry will follow up patients for two years. It will identify common~     sequences of treatments used as well as changes in the treatment of the disease.~     Health-related quality of life will be analysed during the course of the treatment (PanLife).~     Based on the available data a prognostic score will be developed.~   "
112932|NCT02089256|"~     The study investigates the effect of glucagon-like peptide receptor 1 agonist, liraglutide,~     on insulin secretion. Study hypothesis: the effect of liraglutide on insulin release may~     change after repeated administration. The effect of liraglutide on insulin release will be~     tested using graded glucose infusion test (GGIT) in healthy volunteers. GGIT will be~     performed without medication and repeated 12 hours after first dose of liraglutide and after~     3 weeks of treatment with liraglutide.~   "
112933|NCT02089243|"~     Background: There are a variety of treatment options for medically refractory medial temporal~     lobe epilepsy. Evidence from randomized trials indicates vagus nerve stimulation therapy can~     be used as a proven therapy for medically refractory medial temporal lobe epilepsy. Resective~     surgery is one of the most commonly used methods to treat medically refractory medial~     temporal lobe epilepsy. The aim of this study is to compare the effects of vagus nerve~     stimulation therapy and resective surgery in the treatment of the medically refractory medial~     temporal lobe epilepsy.~      Methods/Design: In this article, we report the design and protocol of a randomized controlled~     trial to treat medically refractory medial temporal lobe epilepsy with vagus nerve~     stimulation therapy or resective surgery. In total, 40 patients aged 12 to 60 years with~     medically refractory medial temporal lobe epilepsy will be assessed. There are two treatment~     groups. These patients are randomly assigned to be in one of the following two treatment~     groups, i.e. 1) undergo temporal lobe resection group, 2) receive vagus nerve stimulation~     therapy group. The primary outcome is to assess whether vagus nerve stimulation produces a~     reduction in mean monthly seizure frequency that is comparable to resection at 3 months, 6~     months, 9 months and 12 months of follow-up. The secondary outcomes include the~     neuropsychological, seizure severity, seizure type, quality of life, mood assessment,~     operative and postoperative complications and long-term side effects, compared to resection.~      Discussion: The result of this trial will assess the efficacy of using vagus nerve~     stimulation therapy or resective surgery to treat medically refractory medial temporal lobe~     epilepsy, and to determine a better therapy for treating medically refractory medial temporal~     lobe epilepsy.~   "
112934|NCT02089230|"~     The goal of Phase 1 of this clinical research study is to find the highest tolerable dose of~     MEK162 that can be given to patients with advanced leukemia.~      This is an investigational study. MEK162 is not FDA approved or commercially available. It is~     currently being used for research purposes only. The study doctor can explain how the study~     drug is designed to work.~      Up to 57 patients total will take part in both phases of this study . All will be enrolled at~     MD Anderson.~      The goal of Phase 2 of this clinical research study is to learn if MEK162 can help to control~     AML in older patients with advanced leukemia. The safety of this drug will also be studied.~      This is an investigational study. MEK162 is not FDA approved or commercially available. It is~     currently being used for research purposes only. The study doctor can explain how the study~     drug is designed to work.~      Up to 57 patients total will take part in both phases of this study. All will be enrolled at~     MD Anderson.~   "
112935|NCT02089217|"~     Carotid revascularization for primary prevention of stroke (CREST-2) is two independent~     multicenter, randomized controlled trials of carotid revascularization and intensive medical~     management versus medical management alone in patients with asymptomatic high-grade carotid~     stenosis. One trial will randomize patients in a 1:1 ratio to endarterectomy versus no~     endarterectomy and another will randomize patients in a 1:1 ratio to carotid stenting with~     embolic protection versus no stenting. Medical management will be uniform for all randomized~     treatment groups and will be centrally directed.~   "
112936|NCT02089204|"~     Nasopharyngeal carcinoma (NPC) differs from other head and neck malignancies in terms of its~     epidemiology, pathology, and treatment outcome . It is endemic in China and is one of the~     major public health problems. Concurrent radiotherapy and chemotherapy is the primary~     treatment for patients with NPC. Despite such aggressive treatment, many patients with~     locally advanced NPC still develop locally recurrent disease. Since local control is directly~     related to patient morbidity and mortality in NPC, there is a strong need to identify methods~     to further improve treatment outcome for NPC.~      One strategy to improve local control is to escalate the dose of radiotherapy. This is~     because local control has been shown to be directly related to the radiotherapy dose. Several~     different techniques, including brachytherapy, stereotactic radiosurgery, and dose-painting~     intensity modulated radiotherapy (IMRT), have been used to increase radiotherapy dose.~     However, due to the large number of critical anatomic structures near the nasopharynx,~     dose-escalation in NPC can also lead to increased toxicities. One technique that has achieved~     dose-escalation with minimal increase in toxicity is simultaneous modulated accelerated~     radiation therapy (SMART). The main challenge for such treatment is to identify the~     appropriate tumor volume to receive the high-dose radiotherapy. Conventional dose-escalation~     is conducted using computed tomography (CT) to identify the gross tumor volume (GTV).~     However, recent progress with F-18 fluorodeoxyglucose positron emission tomography/computed~     tomography (18F-FDG-PET/CT) in treatment planning allows more accurate tumor volume~     delineation. We hypothesize that the use of PET/CT in treatment planning can improve~     dose-escalation radiotherapy for NPC which in turn can improve therapeutic efficacy while~     reducing toxicity. PET/CT imaging of tissue hypoxia using [F-18]fluoromisonidazole (FMISO),~     the most widely used nitroimidazole imaging agent.Given that there has been no clinical~     trials directly comparing conventional chemoradiotherapy to CT-guided dose-escalation~     chemoradiotherapy or PET/CT guided dose-escalation chemoradiotherapy in locally advanced~     NPC.This was a study to evaluate the role of FMISO-PET hypoxia imaging for predicting~     survival in NPC,our study aims to compare the local control, overall survival and toxicities~     of the three treatment regimens..~   "
112937|NCT02089191|"~     The purpose of this study is to evaluate tear film stability of DAILIES® AquaComfort Plus®~     (DACP) compared to MyDay® after 12 hours of lens wear.~   "
112938|NCT02089178|"~     The purpose of this study is to compare the effect of total intravenous anesthesia and~     inhalation anesthesia on cancer cell cytotoxicity, micrometastasis and recurrence of tumor in~     patients undergoing breast tumor resection. Using propofol-remifentanil in total intravenous~     anesthesia group and sevoflurane -remifentanil in inhalation anesthesia group.~   "
112939|NCT02089165|"~     The purpose of the study is to compare the acute bioavailability of two different krill oil~     products called krill oil and krill meal in comparison to fish oil product.~   "
112940|NCT02089152|"~     Study hypothesis:~      Prevention programme for melioidosis can reduce incidences of overall hospitalization due to~     infectious diseases and due to culture-confirmed melioidosis in diabetic population in~     northeast Thailand~      This study is a prospective single-blind multicentre stepped wedge cluster randomized~     controlled behaviour change trial in 9,000 diabetics in Ubon Ratchathani, northeast Thailand.~   "
112941|NCT02089139|"~     Discogenic low back pain is the most common form of chronic low back pain. Its diagnosis is~     mainly based on MR imaging, showing MODIC I or II changes in patients with concordant~     symptomatology. The treatment of discogenic low back pain is nevertheless difficult:~     intradiscal therapies (corticosteroids, methylene blue, radiofrequency) have a limited~     efficacy, and surgical procedures (arthrodesis or disc replacement) are a final recourse with~     notable risk of side-effects.~      In this study, the efficacy of intradiscal injection of gelified ethanol (DiscoGel) in~     patients with disabling discogenic pain is assessed.~   "
112942|NCT02089126|"~     The study objective is to demonstrate the superiority and safety of the combination therapy~     (as a fix-dose combination) with Gemigliptin and Glimepiride, compared to the Glimepiride~     monotherapy in patients with type 2 diabetes.~   "
112943|NCT02089113|"~     To evaluate the safety and efficacy of OTX-DP as a sustained release drug (dexamethasone)~     depot when placed in the canaliculus of the eyelid for the treatment of post-surgical~     inflammation and pain in subjects who have undergone cataract extraction with intra-ocular~     lens implantation.~   "
112944|NCT02089100|"~     The previous reported phase I study allows us to prospectively define the optimal total dose~     in different metastatic locations (88). However, several questions are still unanswered such~     as the adequate timing of the stereotactic body radiation therapy (SBRT) in oligometastatic~     disease. Indeed, there are two different oligometastatic states: de novo, i.e. occurring at~     first metastatic presentation without any previous systemic therapy; and secondary, defined~     as residual disease after systemic treatment.~      The investigators wish to prospectively study the role of metastases SBRT with curative~     intent in de novo oligometastatic disease.~      This clinical trial would be the first randomized study studying SBRT at onset of the~     metastatic disease. If this trial shows a PFS improvement, it will definitively change the~     standard of treatment and it will highlight SBRT as a key treatment of metastatic disease. It~     will confirm the oligometastasis hypothesis as well as the Simon Norton hypothesis (92).~   "
112945|NCT02089087|"~     This is a first-in-human study to investigate the safety, tolerability, pharmacokinetics, and~     pharmacodynamics of single intravenous and subcutaneous doses of CFZ533 in healthy subjects~     and intravenous doses in rheumatoid arthritis patients.~   "
112946|NCT02089074|"~     Use of drugs is an important factor in secondary prophylaxis after transient ischemic attack~     (TIA), but studies show that adherence to the prescribed drugs is often poor. This randomised~     controlled trial aims to investigate whether a systematic follow up of drug treatment using~     medication reconciliation, medication reviews and patient counselling by clinical~     pharmacists, improves adherence and/or decreases cardiovascular events the first three months~     and the first year after TIA. Patient satisfaction will also be compared between the two~     groups.~   "
112947|NCT02089061|"~     This purpose of this study is to assess the effects of BMS-919373 on the single dose~     Pharmacokinetics (PK) of Rosuvastatin and Atorvastatin in healthy subjects.~   "
112948|NCT02089048|"~     Phase I, open-label study in 15 healthy adult subjects receive 6 mg of auranofin orally once~     every 24 hours for 7days. Blood samples will be taken for 17 weeks following the last dose of~     auranofin for determination of terminal phase pharmacokinetic parameters. Stool samples will~     also be obtained for the measurement of gold.~   "
112967|NCT02088801|"~     In this second phase of the multicenter study the investigators are going to evaluate the use~     of three different videolaryngoscopes in patients undergoing elective surgery requiring~     general anesthesia with intubation. The investigators are hypothesizing that these three~     videolaryngoscopes will succeed for intubation at first attempt in at least 90% of all cases~     using a difficult airway simulation with extrication collars. As the gold standard, a~     standard Macintosh blade is being used for comparison.~      The study consists of 4 arms. Each arm includes 120 patients, sums up to a total of 480~     patients.~   "
114702|NCT02066064|"~     The purpose of this study is to compare the adenoma detection rate of G-EYE™ high definition~     colonoscopy with that of standard high definition colonoscopy.~   "
112949|NCT02089035|"~     The consumption of milk and dairy products is recognised as an essential part of a healthy~     diet as it represents an important source of key micro- and macronutrients. Nevertheless,~     there is still a widespread conviction that the overall high energy density and concentration~     of long-chain saturated fatty acids (SFA) present in dairy have detrimental health effects,~     contributing to the progression of cardiovascular disease, obesity and diabetes.~      Supplementation of the bovine diet with a source of MUFA, such as rapesee oil, has become an~     achievable strategy in order to reduce the amount of SFA present in dairy products.~      The aim of this project is to observe the effects of three types of dairy products (UHT milk,~     cheese and butter) produced from milk derived from cows fed withhigh-oleic sunflower oil, on~     CVD risk biomarkers and plasma total cholesterol levels in adults with an increased risk of~     developing CVD. The aim is to determine whether an isoenergetic exchange of dairy products~     will affect vascular function and CVD biomarkers.~   "
112950|NCT02089022|"~     The aim of this study was to evaluate the effect of ice and shortwave diathermy in different~     regions of lower limb neuromuscular response and balance.~   "
112951|NCT02089009|"~     1. To compare quality and usability of images taken by two different camera-systems without~          dilating the pupil.~        2. To compare the retinal vessel diameters based on the images of to different~          camera-systems.~        3. To detect changes in retinal vessel diameters while pregnancy and after delivery.~   "
112952|NCT02088996|"~     Chemotherapy-induced peripheral neuropathy (CIPN) implies sensory or deficits pain, loss of~     motor functions and impaired proprioception which in turn may affect balance and fine motor~     skills. It is mainly subjected to the peripheral parts of the extremities, may be transient~     or permanent.CIPN is a common, potentially severe and often dose-limiting side effect after~     patient exposure of numerous classes of antineoplastic agents including platins, taxanes,~     vinca alkaloids, bortezomib and thalidomide. At present, no evidence based treatment of CIPN~     is available. A variety of different drugs or drug combinations have been clinically tested~     but the value of these treatments is uncertain. Many patients with CIPN are referred to~     physiotherapy but still this treatment is more based on clinical experience and tradition~     than scientific evidence. In a nonrandomized study, sensory electrical stimulation(MC5-A~     Calmare ®) was tested on 16 persons.The electrodes were placed on the hand and foot and~     intensity was gradually increased and given daily for 10 days. Pain was reduced 20% in~     numeric pain score for 15 of the 16 participating patients.~      Our clinical experience indicates that treatment with long wave diathermy (LWD) may decrease~     CIPN symptoms. This treatment produces electromagnetic radiation according the capacitor~     method with heightened circulation and heat which is assumed to reduce pain. Interferential~     Therapy (IT) is an electro-physical method which is based on an electric field in the painful~     area through four electrodes or vacuum cups placed on the skin. Increased blood circulation~     and pain relief is supposed to be achieved. IT use two different intermediate frequencies~     (1001-10000 Hz) alternating currents in the painful area. The treatment effect correspond to~     the gate control-theory; inhibition of pain signals in small diameter fibers by activity in~     large-diameter Aβ-fibers by spinal neurons. Some studies have shown effect in treating pain~     with interferential currents when pain is experimentally induced or induced by cold in~     otherwise pain-free volunteers, when compared to a control or placebo.~      The hypothesis of this study is that the combination therapy longwave diathermy on high power~     and interferential currents gives better results than longwave diathermy on low power.~   "
112953|NCT02088983|"~     People with schizophrenia tend to have problems with attention and concentration. Studies~     found that these patients are unable to block or gate out non-relevant and distracting~     information (e.g., noises). This may lead to brain overload. Cognitive abilities like~     concentration, memory, and learning may worsen. This ability to filter sensory information~     has been linked to a gene that affects the way nicotine acts in the brain. Patients with~     schizophrenia have a high rate of cigarette smoking. 60% to 90% smoke compared with 25% of~     the general population. It has been suggested that these patients may use nicotine to improve~     their ability to block out distracting information. Brain wave activity (EEG) in response to~     sounds has been proved useful in understanding this gating problem. The present study uses~     EEG measures and performance tasks to find out what a new nicotine-like treatment, which will~     be added to ongoing treatment medications, does to gating and cognition. It is hoped that~     this new treatment will improve the way in which patients process information, as this may~     help them in day-to-day activities.~   "
112954|NCT02088970|"~     The corneal collagen cross linking is currently used in the treatment of keratoconus but this~     procedure has also a sterilizing non-specific effect on bacteria and fungus. So the corneal~     cross linking in association with the antibiotic treatment could result in a reduction of the~     duration of epithelial complete healing of the cornea.~   "
112955|NCT02088957|"~     The primary objective of this study is to compare the efficacy of Brivaracetam and Phenytoin,~     both administered intravenously, in adult subjects experiencing nonconvulsive electrographic~     seizures.~   "
112956|NCT02088944|"~     Many studies reveal that infliximab (IFX, an immunoglobulin gamma-1 antibody)can response~     well to Crohn's Disease(CD) patients who are intolerant of corticosteroids and~     immunosuppressant,or steroids-dependent .More over,A complex fistula in CD is an indication~     for early IFX therapy in conjunction with surgical drainage.Some papers claim that IFX may~     prevent enterectomy CD patients from relapsing. Those with risk factors which at diagnosis~     associated with  disabling disease include age < 40 years, initial need for steroid~     therapy, and the presence of perianal disease are recommended to use IFX early.~      IFX is approved by State Food And Drug Administration(SFDA) in 2007 ,but the safety is still~     controversial by then.Some studies proclaim that the side effect may be infections,acute~     infusion reactions,anaphylactic reactions,autoimmunity,drug-induced lupus,congestive heart~     failure,abortion and demyelination,etc.~      So some problems still need to be settled as follows:1)all the the infliximab dates are from~     other countries,there is rare date from the Chinese,especially the large quantity of random~     controlled studies and the CD patients with enterectomy.2)despite of the large number of~     databases from the international ,when to stop and the predictor of the response is still~     obscure.3)The high cost of IFX may hinder its applications,especially for the moderate to~     severe active CD patients who take mesalazine and/or immunosuppressant to maintain~     remission.In addition,the pathogenic age segments in the occurence of CD: from 15~ 50 years~     old ,so they suffer from the disability of self-improvements.~      The main object of the clinical trial is to complete the database of Chinese CD patients~     ,especially the safety and efficacy of IFX and those with enterectomy.Then we can record the~     clinical manifestations of the moderate to severe CD patients with the use of IFX or~     conventional drugs,including the dose,course and Concomitant treatment.We can also study the~     predictor and the appropriate time to stop using IFX .We can make the mode of cost-benefit~     help the patients choose the best project.~   "
112968|NCT02088788|"~     Radiation exposure to operator is an occupational hazard of invasive cardiologists. During~     radial access for diagnostic catheterization, a new radio-dense arm board is advertised to~     reduce operator radiation exposure. The investigators randomize patients to a new radio-dense~     armboard versus a standard radio-transparent armboard during diagnostic catheterization and~     measure radiation exposure to the operator. Both groups have a radio-dense pelvic shield in~     place. The investigators hypothesize that operator radiation dose will be decreased by use of~     the radio-dense armboard.~   "
114703|NCT02066051|"~     The purpose of this study was to see if Intense Pulsed Light (IPL) can be used safely and~     effectively to help treat dry eyes from ocular rosacea after chronic graft-versus-host~     disease (GVHD). Current treatment options for this disease are limited.~   "
112957|NCT02088931|"~     The purpose of this study is to test the safety of the experimental therapy of a single~     infusion of Regulatory T cells (Tregs). The investigators want to find out what effects, good~     or bad, Tregs will have on the kidney transplant patients.~      There are different types of T cells. This study uses Regulatory T cells (Tregs), which are~     found in the blood and are part of the immune system that stops other immune cells from~     working. Tregs help to turn off the immune system after other immune cells have finished~     tackling outside infections, and Tregs keep the immune system in check so that the body does~     not attack itself. The researchers are hoping that, by giving an infusion of Tregs that the~     attack on the kidney can be stopped and kidney function will be stabilized. It is not known~     if the Treg experimental therapy can stop the inflammation in the kidney.~      In this study, the researchers will take some of Tregs from the patient, multiply them in the~     laboratory, and then infuse them back into the patient. The procedure used to multiply Tregs~     is an experimental process performed in the laboratory. Similar procedures done with mice~     have been shown to reverse inflammation but it is not known whether the results will be the~     same in humans. This therapy has not yet been done in humans outside of a research study.~   "
112958|NCT02088918|"~     A Randomized, Open-label, Single-dose, 2-Sequence, 2-Period, Crossover Study to Assess Safety~     and Pharmacokinetics of a Nateglinide/Metformin HCl Combined Tablet Compared with a~     Nateglinide 120 mg Tablet and Metformin HCl 500 mg Tablet under Fasting Conditions in Healthy~     Male Subjects~   "
112959|NCT02088905|"~     The aim of the current proposal is to determine if the PCIT treatment manual can be~     successfully utilized for preschoolers with ASD and disruptive behavior (across a range of~     intellectual functioning levels) and to evaluate its ability to significantly decrease~     measures of problem behavior. It is hypothesized that the current manual will require few~     modifications for use with ASD and that, in comparison to a wait-list control group, families~     who undergo PCIT training will evidence significant gains on measures of parenting stress,~     child externalizing behaviors and compliance to parental requests. To address the pilot study~     aims, we will recruit a total of 20 families of children with ASD (ages 2.6-6.11 years) whose~     children are already receiving intensive, one-on-one behavioral treatment services (15-30~     hours per week) but no structured parent training. Families will be randomized to either~     intensive services + PCIT or intensive services alone (wait list control). Assessments will~     be completed at baseline, mid-treatment (10 weeks post baseline), post-treatment (20 weeks~     after the baseline assessment) and long-term follow-up (12 weeks post-treatment). PCIT~     families will attend 20 weekly, one-hour coaching sessions. Both active treatment and~     wait-list control families will continue to receive intensive ABA services in the home or~     community. Control families will receive PCIT training after 16 weeks on the wait-list. The~     aims of the pilot study are:~        1. To assess the utility of the current PCIT treatment manual with preschoolers with ASD~          and disruptive behavior and their parents;~           Hypothesis 1: The current PCIT treatment manual will be able to be utilized with~          families of children with ASD with only minimal modifications.~           Hypothesis 2: Families of children with ASD will consistently attend PCIT sessions.~        2. To determine if PCIT with this population will result in an increase in appropriate~          parent behaviors and a subsequent decrease in targeted child behaviors (e.g., direct~          assessment of noncompliance, behavior rating scales).~      Hypothesis 3: Families receiving PCIT training will evidence statistically greater decreases~     on measures of disruptive behavior, quality of parent-child interactions and parental stress~     than families on the wait-list control group.~      Hypothesis 4: Gains attained at 20 weeks will be maintained at a 12-week post-treatment~     follow-up.~   "
112960|NCT02088892|"~     TB031 is a challenge study comparing two different strains of the Bacille Calmette-Guérin~     (BCG) vaccine at standard and high dose.~   "
112961|NCT02088879|"~     The chest compression depth decreases over time after starting continuous chest compression~     due to the rescuers' fatigue.~      The investigators hypothesized that the frequency parameters from surface electromyogram from~     each muscle during chest compression may reflect the muscle fatigue of the rescuers.~      Then investigators can identify which of the body are mainly used and get tired by continuous~     chest compression using surface electromyogram.~   "
112962|NCT02088866|"~     The purpose of this investigation is to evaluate if topically applied lidocaine, in the form~     of lidocaine patches, reduces the burden of chronic subjective tinnitus in a consistent and~     measurable way.~   "
112963|NCT02088853|"~     Human beings are 'omnivores' meaning that all principal components of food (i.e. the~     macronutrients: carbohydrates, fat, proteins) can be assimilated by the gastrointestinal~     tract. When the gut mucosa is exposed to dietary changes it adjusts its functional behaviour.~     For example, a fatty diet demands certain digestive mechanisms, whereas others are needed to~     take care of a carbohydrate rich diet. Such dietary induced changes in appearance and~     functionality of the small intestinal mucosa have been described in animals but only little~     is known about it in man. The present project aims at elucidating in man if a 2 weeks diet~     dominated by either fat or carbohydrates, but with similar energy content, is associated with~     changes in the small intestinal mucosal appearance and metabolic signalling capacity.~   "
112964|NCT02088840|"~     All patients undergoing autologous or allogeneic stem cell transplant (SCT) for any~     underlying disease will be monitored for severe infections by gram negative bacteria (SIGNB)~     during the engraftment period. The follow up will be stopped at 4 months from the day of~     transplant. About 50 transplant centers will be involved in the study.~   "
112965|NCT02088827|"~     The rates of sedentary activity are increasing. Studies have shown that time spent on doing~     sedentary activities is an independent risk factor for cardiovascular disease. Prior studies~     have shown that interrupting inactivity improved the body's handling of blood glucose and~     gene expression. The investigators plan to explore this further by examining the effects of~     interrupting 4 hours of inactivity with 2 minutes of moderate intensity exercise every 20~     minutes on the following metabolic parameters: blood pressure, cortisol, C-Reactive Protein,~     glucose and insulin levels.~   "
112966|NCT02088814|"~     Background: Previous studies have found considerable rates of posttraumatic stress disorder~     (PTSD) or clinically relevant posttraumatic stress symptoms (PTSS) in preschoolers with~     injuries following accidental trauma. In consequence, secondary preventive efforts (early~     interventions) should be undertaken to minimize such long-term deleterious consequences in~     children.~      Aims: The proposed study aims at examining the effect of a newly developed, standardized~     early psychological intervention in reducing posttraumatic maladjustment and in enhancing~     health-related quality of life in children ages 1 to 4 years with acute burn injuries.~      Method: The study is designed as a randomized controlled trial within a stepped procedure.~     First, eligible children will be screened 5 to 7 days post injury by means of a standardized~     measure for their risk of developing PTSS. After a baseline assessment, children at risk will~     then be randomly allocated to either a control group (standard medical care) or an~     intervention group. Participants of the intervention group will be provided with the~     standardized EPICAP 1-4 intervention which uses established cognitive-behavioral techniques~     and is directed to the parents. The intervention consists of two face-to-face sessions (at~     baseline and 1 week later) and a follow-up call or short follow-up face-to-face meeting (6~     weeks after the first session). Blinded follow- up assessments with standardized parent~     report measures will be conducted at 3 and 6 months post injury. The primary outcome measures~     are child PTSD and PTSS, secondary outcome measures include child behavior and health-related~     quality of life. In addition, a variety of socio-demographic, medical and parental variables~     will be assessed as co-variates. Children screened as low-risk will be reassessed only at 6~     months to make sure that the screening procedure is valid.~   "
113005|NCT02088307|"~     Evaluation of the metabolic and physiological characteristics of patients with diagnosed~     Cardiovascular Disease following administration of the Cardiovascular vitamin, CardioLife.~   "
112969|NCT02088775|"~     This clinical trial studies positron emission tomography (PET)-computed tomography (CT) in~     determining the radiation dose delivered with radioactive spheres to patients with liver~     metastasis or primary liver or biliary cancer. Comparing results of diagnostic procedures~     dose before and after delivery of radioactive spheres to the liver may help determine~     radioembolization dose and plan the best treatment for liver metastasis or primary liver or~     biliary cancer.~   "
112970|NCT02088762|"~     Objective: To investigated the impact of the excision of melanoma 2mm≤ in thickness with 1cm~     surgical margins on survival of the patients compared with 2 cm surgical margins.~      Background: Early recognition and appropriate excision play a crucial role in management of~     malignant melanoma, while the size of surrounding normal skin that should be excised is area~     of controversies.~      Methods: The investigators will conduct a retrospective population-based survey in patients~     with primary melanoma 2 mm≤ in thickness undergoing tumor excision with 1 cm and 2 cm margins~     in the investigators center. For both groups, the patients' charts reviewed for data~     including patient gender, age, tumor location, tumor type, Clark's level, Breslow thickness,~     tumor type, presence of ulceration, findings of sentinel nodes, local recurrences,~     locoregional metastases, disease free survival and overall survival were calculated for both~     groups.~   "
112971|NCT02088749|"~     The purpose of this study is to compare the 6- and 12-month weight changes associated with~     lifestyle interventions delivered in a large group or small groups of participants. It is~     hypothesized that participants receiving treatment in a small group will have greater weight~     loss than those assigned to a larger group.~   "
112972|NCT02088736|"~     In patients with out-of-hospital cardiac arrest in Singapore, investigators aim to assess the~     benefit of introducing a resuscitation protocol including the use of intravenous (IV) access~     and/or intraosseous (IO) vascular access in the pre-hospital setting.~      The assumption is that low vascular access rates could be due to difficulty of setting IV~     cannulas in the field due to certain factors like poor lighting or space constraints. Thus,~     by introducing a protocol including IO access for difficult IV cases, success rates for~     vascular access will be higher and this might lead to higher survival rates.~      This will be a study comparing 'IV+IO' and 'IV alone' protocols in patients with cardiac~     arrest managed by Singapore Civil Defence Force (SCDF) emergency ambulance service. The trial~     will recruit 400 patients over 1 year. Each of the 30 SCDF ambulances will provide both~     'IV+IO' and 'IV alone' treatments in 2 consecutive phases of 6-months in order to allow for~     all ambulance crew a chance to be trained on usage of IO. Currently, IO insertion is the~     accepted standard of care in Singapore General Hospital, Department of Emergency Medicine.~   "
112973|NCT02088723|"~     The purpose of this study is to determine if the elevation of the head of the bed in patients~     with obstructive sleep apnea can decrease the apnea-hypopnea index. First the investigators~     will do a standard polysomnography and see if the patients are included analysing the~     criteria like apnea-hypopnea index equal or more than 5. Within 2 weeks the patient will do~     the second polysomnography but this will be with a elevation of the head of the bed (15 cm of~     elevation of the bed doing a inclination). Then the investigators will compare the data of~     apnea-hypopnea index in the standard polysomnography versus the index with the elevation of~     the head of the bed.~   "
112974|NCT02088710|"~     The purpose of this study is to evaluate the role of patients' response expectations for~     nocebo side effects, quality of life and adherence during adjuvant endocrine treatment (AET).~     Furthermore, this study analyses the effects of a structured treatment information on~     patients' satisfaction with information, response expectations, knowledge and adherence.~   "
112975|NCT02088697|"~     The purpose of this study is to investigate the bioequivalence of ASC-01 Placebo and~     sertraline Tablet in Japanese healthy male subjects.~   "
112976|NCT02088684|"~     The purpose of this trial is to explore the clinical utility of the three investigational~     agents in HR+, HER2- breast cancer. LEE011 (CDK4/6 inhibitor), BKM120 (PI3K-pan class~     I-inhibitor) and BYL719 (PI3K-alpha specific class I inhibitor) in combination with~     fulvestrant.~      This is a multi-center, open-label Phase Ib/II study. The Phase Ib portion of the study is a~     dose escalation to estimate the MTD and/or RP2D for three regimens: LEE011 with fulvestrant;~     LEE011 and BKM120 with fulvestrant; LEE011and BYL719 with fulvestrant.~      The Phase II portion of the study will be a randomized study to assess the anti-tumor~     activity as well as safety and tolerability of LEE011 with fulvestrant to LEE011 and BKM120~     with fulvestrant, and LEE011 and BYL719 with fulvestrant in patients with ER+/HER2- locally~     advanced or metastatic breast cancer.~      Approximately 216 adult women with ER+/HER2- locally advanced or metastatic breast cancer~     will be enrolled.~   "
112977|NCT02088671|"~     The objective of this clinical study is to investigate whether the NeuroSENSE is an adequate~     monitor of hypnotic depth-of-anesthesia (DOA). Therefore, this study will investigate whether~     the information provided by the NeuroSENSE Monitor can help in assessing the hypnotic effect~     of anesthetics in adult patients undergoing general anesthesia.~   "
112978|NCT02088658|"~     The purpose of this study is to test the usefulness of an intervention that combines~     technology with diabetes education and skills training. This study has been designed~     specifically for African Americans with poorly controlled type 2 diabetes.~   "
112979|NCT02088645|"~     The purpose of this study is to determine the use of 177Lu-PP-F11N for imaging and therapy of~     patients with advanced medullary thyroid carcinoma (MTC). 177Lu-PP-F11N is a gastrin~     analogon, binding to cholecystokinin-2 receptors. This receptors show an overexpression on~     more than 90 % of medullary thyroid carcinomas.~      In the pilot (phase 0) study we will correlate the tumour detection rate with the surgery and~     histology (proof of concept study). Furthermore, kidney protection and dosimetry studies will~     be performed in order to determine the kidney protection protocol and starting activity for~     the dose escalation study in the following, dose escalation (phase I) study. In the phase I~     study we will determinate the maximum tolerated dose of 177Lu-PP-F11N in patients with MTC.~     Furthermore, correlation with tumour radiation dose and treatment response as well as organ~     radiation doses and maximal tolerated dose will be performed in order to allow prospective~     individual patient tailored therapy planning.~   "
113028|NCT02088008|"~     A randomized, open-label, single dosing, two-way crossover clinical trial to compare the~     safety/tolerability and pharmacokinetics of the combination of Cilnidipine 10mg and Valsartan~     160mg in comparison to each component coadministered in healthy male volunteers.~   "
112980|NCT02088632|"~     IncobotulinumtoxinA (Xeomin®) is a neurotoxin which inhibits the release of certain chemicals~     at the nerve terminals. It blocks cholinergic transmission at the neuromuscular junction by~     inhibiting the release of acetylcholine from motor neurons. In addition it blocks the release~     of Substance P (SP) and Calcitonin Gene Related Peptide (CGRP) from C fibers involved in pain~     perception. This study is designed to see if Xeomin® is superior to placebo in the treatment~     of medically refractory trigeminal neuralgia (TN). Subjects will be asked to maintain an~     attack diary throughout the study. They will also be asked to attend 4 office visits; Visit~     1- Screening Visit, Visit 2- Injection Visit, Visit 3- Follow-Up Visit and Visit 4- Final~     Visit. At the end of the study the active (Xeomin®) and placebo groups will be compared to~     see if one group had better relief than the other.~   "
112981|NCT02088619|"~     The purpose of this 2-group randomized clinical trial is to: 1) examine the feasibility and~     acceptability of a 3-month positive-emotion focused therapy (Quality of Life Therapy)~     modified specifically for patients with implantable cardioverter defibrillator (ICD); and 2)~     obtain estimates of effect size for QOLT compared to Heart Healthy Education on the changes~     in arrhythmia frequency and biomarkers of autonomic function, as well as changes in emotion,~     mood, and well-being across time (baseline, 3 & 9-months). It is hypothesized that the QOLT~     will promote improvements in autonomic function, reduced arrhythmia frequency, and improved~     psychological well-being.~   "
112982|NCT02088606|"~     A prospective, multicenter, interventional study to collect confirmatory evidence on the~     safety and effectiveness of the TactiCath® percutaneous ablation catheter for the treatment~     of symptomatic paroxysmal atrial fibrillation using contact force assisted irrigated~     radiofrequency ablation.~   "
112983|NCT02088593|"~     Medical students score higher than the general population on measures of depression, anxiety,~     fatigue, poor sleep and sleepiness. Data suggest that disparages in circadian phase might~     contribute to these problems. From an internal validity standpoint, first year medical~     students are an ideal group to study. The majority of the students will be matched on~     variables such as education, age, and intelligence. However, more importantly, they have a~     nearly identical life style when it comes to factors such as schedule, living conditions,~     level of stress, and timing of stressors. The specific aim and hypothesis is:Medical students~     randomized to sleep hygiene counseling plus simulated dawn will report less depression,~     anxiety, fatigue, sleepiness, and sleep disruption (as measured by standardized~     questionnaires) than students randomized to just sleep hygiene counseling.~   "
112984|NCT02088580|"~     This study will attempt to study the effect of adjunctive chronotherapy (wake therapy, sleep~     phase advance, and bright light therapy) on acutely depressed inpatients. The investigators~     will attempt to recruit individuals admitted to the acute inpatient unit and study the~     results of the treatment on depressive symptoms, and suicidality.~   "
112985|NCT02088567|"~     The overall objective of this study is to evaluate the effectiveness of dHACM in reducing~     scar tissue formation in total knee replacement patients.~   "
112986|NCT02088554|"~     To evaluate the safety and effectiveness of the Model 400 aortic valve bioprosthesis.~   "
112987|NCT02088541|"~     This is a randomized, multicenter, open-label, Phase 2 study of the SINE compound, Selinexor~     given orally versus specified investigator choices (one of three potential salvage~     therapies). Patients age ≥ 60 years with relapsed/refractory AML of any type except for AML~     M3, after one prior therapy only, who have never undergone and who are not currently eligible~     for stem cell transplantation and are currently deemed unfit for intensive chemotherapy.~   "
112988|NCT02088528|"~     Medical treatment of glaucoma in West Africa is often unsuccessful because of the cost of~     medications, disease severity and poor compliance. Surgical treatment is likely to be a more~     practical solution.~      The purpose of this study is to compare the safety and efficacy of the Aurolab glaucoma~     drainage device against trabeculectomy with mitomycin-c in a prospective randomised surgical~     study.~   "
112989|NCT02088515|"~     The treatment of squamous cell carcinoma of lung has not improved suffuciently. Nedaplatin is~     a second-generation platinum compound that is more active against squamous cell carcinoma of~     the lung with a response rate of 60%, issued by the finished Phase II trial in Japan.~   "
112990|NCT02088502|"~     The aim of this study is to determine the efficacy of Theophylline, N-Acetylcysteine and, and~     Theophylline plus N-acetylcysteine in the prevention of contrast-induced nephropathy.~     Investigators assume that Theophylline plus N-acetylcysteine is more effective than~     Theophylline alone and N-acetylcysteine alone. Investigators include patients referring for~     elective coronary angiography or angioplasty and allocate them to each of the mentioned~     treatments from 24 hours before to 48 hours after administration of contrast material.~     Investigators then measure serum creatinine and see if it is raised by ≥ 0.5 mg/dL or ≥ 25%~     of the baseline value.~   "
112991|NCT02088489|"~     Porous tip catheter use reduces procedure time and RF time in atrial flutter ablation with~     the same safety.~   "
112992|NCT02088476|"~     Candidemia has emerged as an important cause of hospital-associated blood-stream infection in~     children. The purpose of this study was to identify differences in distribution of candida~     species, risk factors, treatment, and clinical outcome of candidemia in children. This study~     in children ≤18 years with blood culture proven candidemia identified between 2004 and 2012.~     Analyses included the determination of causative candida species, resistance to antifungals~     and clinical outcome, as well as the identification of potential risk factors associated with~     candidemia.~   "
112993|NCT02088463|"~     The study was conducted to the following purposes~        1. To investigate the effect of lumbar mobilization on muscle activity in postpartum~          mechanical low back pain.~        2. To investigate the effect of lumbar mobilization on pain intensity in postpartum~          mechanical low back pain patients.~        3. To investigate the effect lumbar mobilization on functional disability in postpartum~          mechanical low back pain patients.~        4. To compare between the effects of lumbar mobilization, tactile stimulation (placebo~          treatment) and traditional treatment in postpartum mechanical low back pain patients.~   "
113029|NCT02087995|"~     To establish the performance of the Dexcom G4 Platinum with a Modified Algorithm continuous~     monitoring system when compared to a laboratory reference measurement.~   "
116936|NCT02036918|"~     This study aims to evaluate patients with metastatic castrate-resistant prostate cancer~     (mCRPC) undergoing treatment with sipuleucel-T for evidence of treatment-associated immune~     activation in lymph nodes and peripheral blood.~   "
112994|NCT02088450|"~     The Syst-Eur Trial is a concerted action of the European Community's Medical and Health~     Research Programme. The trial is carried out in consultation with the World Health~     Organization, the International Society of Hypertension, the European Society of Hypertension~     and the World Hypertension League. Syst-Eur is a multicentre trial designed by the European~     Working Party on High Blood Pressure in the Elderly (EWPHE), to test the hypothesis that~     antihypertensive treatment of elderly patients with isolated systolic hypertension results in~     a significant change in stroke morbidity and mortality. Secondary endpoints include~     cardiovascular events, such as myocardial infarction and congestive heart failure. To be~     eligible patients must be at least 60 years old and have a systolic blood pressure averaging~     160-219 mmHg with a diastolic pressure less than 95 mmHg. Patients must give their informed~     consent and be free of major cardiovascular and non-cardiovascular diseases at entry. The~     patients are randomized to active treatment or placebo. Active treatment consists of~     nitrendipine (10-40 mg/day), combined with enalapril (5-20 mg/day) and hydrochlorothiazide~     (12.5-25 mg/day), as necessary. The patients of the control group receive matching placebos.~     The drugs (or matching placebos) are stepwise titrated and combined in order to reduce~     systolic blood pressure by 20 mmHg at least to a level below 150 mmHg. Morbidity and~     mortality are monitored to enable an intention-to-treat and per-protocol comparison of the~     outcome in the 2 treatment groups.~   "
112995|NCT02088437|"~     Every day, more than 40 Australian break their hip, Most are over the age of sixty five. Hip~     fractures are a significant problem for the older people, the hospital system and community~     as a whole because of the increasing numbers of fractures and the cost of hospitalisation and~     ongoing care. After one year, less than half of all people with a hip fracture can walk as~     well as they did before the fracture. Physiotherapy in the acute hospital setting is an~     integral part of patient care, although the intensity of physiotherapy a patient receives is~     variable and the optimal number of treatment sessions per day remains unknown. Studies in~     other patient groups have shown that increased physiotherapy can improve patient outcomes by~     increasing muscle strength and mobility. It can also reduce the negative effects of bed rest~     such as muscle wasting, blood clots in the lungs or leg veins and chest infections such as~     pneumonia. This study aims to investigate the effectiveness of an intensive physiotherapy~     program in hip fracture patients to further understand this and the effect it has on patient~     function.~      In this research the investigators will randomly allocate patients into 2 groups; usual care~     and intensive physiotherapy. The usual care group will have physiotherapy treatment daily~     whereas the intensive physiotherapy group will have an additional daily treatment by a~     physiotherapist as well as a daily treatment by an allied health assistant. The objectives~     are to achieve better functional outcomes in the patient's hospital stay (ie improved~     mobility), reduce the time for patients to be physically ready to go home, increase the~     number of patients able to go directly home or to fast stream rehabilitation (rather than a~     slow stream option).~      If increased intensity of physiotherapy is found to improve patient's mobility outcomes, this~     research will provide the confidence to endorse a change to current clinical practice.~   "
112996|NCT02088424|"~     THE INSULIN RESISTANCE IN RECURRENT ABORTION~   "
112997|NCT02088411|"~     The aim of this randomized, double-blind, placebo-controlled, comparator-controlled trial was~     to evaluate the safety and efficacy of an enzyme combination, as Wobenzym®, in adults with~     moderate-to-severe osteoarthritis (OA) of the knee.~   "
112998|NCT02088398|"~     This study will be an open-label, randomized, single dose, 3-period crossover PK study. This~     study will comprise 3 treatment periods with a 4-day washout between periods. On Day -1,~     subjects will be randomized to 1 of 6 treatment sequences. On Days 1, 5, and 9, subjects will~     be administered Treatment A, B, or C according to the randomization schedule.~        -  Treatment A: a single dose of 160 mg ACY-1215 CLF (20 mg/mL) in the fed state~        -  Treatment B: a single dose of 120 mg ACY-1215 ALF (10 mg/mL) in the fed state~        -  Treatment C: a single dose of 120 mg ACY-1215 ALF (10 mg/mL) in the fasted state~   "
112999|NCT02088385|"~     Hemospray (TC-325, Cook Medical Inc, Winston-Salem, NC, USA), a new adsorptive nanopowder~     hemostatic agent for endoscopic treatment of high-risk bleeding peptic ulcers, provides~     significant ease of administration compared to the combined conventional technique of~     saline-adrenaline injection with mechanical clip or heater probe applications. The Hemospray~     powder is easily applied on ulcers at difficult endoscopic positions and ulcers with fibrotic~     bases, where the combined conventional technique has limited efficacy. Building up on~     preliminary work from small single-arm studies, the investigators aim to establish the~     efficacy and safety of Hemospray in treating bleeding peptic ulcers in comparison with the~     combined conventional technique. The investigators propose a pilot study to establish our~     centre's feasibility of performing a prospective, randomized, parallel group trial, which~     compares the efficacy of Hemospray with the combined conventional technique, in the~     endoscopic treatment of high-risk bleeding peptic ulcers. Patients with high-risk bleeding~     peptic ulcers will be treated with Hemospray to determine its initial hemostasis rate~     (defined as endoscopically verified cessation of bleeding for at least 5 minutes after~     endoscopic treatment), rebleeding rate (recurrent hemorrhage during a 4-week period following~     the initial hemostasis) and its safety profile.~   "
113000|NCT02088372|"~     Evaluate Clinical Performance of Vanguard Knee with E1 Bearing in Korean Patient Population~   "
113001|NCT02088359|"~     Infants are exposed to either continuous bright light continuous near darkness or~     unstructured combination of the two. The investigators primary objective is to determine the~     effectiveness cycled light and near darkness on growth in preterm infants.~   "
113002|NCT02088346|"~     The purpose is to evaluate the effectiveness and safety profile of telemedicine consultation~     system in making decision on IV thrombolysis.~   "
113003|NCT02088333|"~     The purpose of this study is to determine whether a multilevel mHealth intervention (mCRC)~     can increase the percentage of patients who receive colorectal cancer screening. The mCRC~     intervention will include a tablet-based patient education program, clinic protocols to~     facilitate the ordering of CRC screening tests, and electronic messaging with patients to~     promote screening. The investigators hypothesize that participants randomized to mCRC will be~     more likely to complete screening compared with those randomized to the control arm of the~     study. Additionally, the investigators hypothesize mCRC will increase several intermediate~     outcomes (such as knowledge, attitudes, beliefs, and test ordering) which will predict~     completion of screening. Lastly, the investigators hypothesize the mCRC intervention will add~     little to the overall cost of screening.~   "
113004|NCT02088320|"~     The focus of the present study is to further develop an echocardiographic technique to~     measure cardiopulmonary transit time (PTT) and pulmonary blood volume (PBV) using ultrasound~     contrast.~      The Specific Aims for the present study are as follows:~        1. To compare echocardiography-based PTTs and cardiac MRI-based PTTs obtained using a~          'peak-to-peak' method~        2. To further quantify the relationship between echocardiographically-derived PTT, using~          Optison, and existing echocardiographic methods used to determine ventricular function~        3. To measure the reproducibility of echocardiographically-based PTT using Optison.~   "
113006|NCT02088294|"~     The childhood obesity epidemic, which falls disproportionately on Latino adolescents,~     represents a major public health threat to the current generation of youth, and therefore to~     the health of the nation overall. This project directly addresses the role of psychosocial~     stress in promoting obesity and metabolic disease risk, and investigates the role of the~     mind-body CAM intervention of guided imagery in both reducing stress and promoting healthy~     lifestyle behaviors that could dramatically improve the metabolic health of today's youth.~   "
113007|NCT02088281|"~     The potential effect of indigo naturalis on the immune system is unknown. The investigators~     hypothesize that the therapeutic effect of indigo naturalis in psoriasis may involve~     inhibiting the activation of Th1 and Th17 cells that produce pro-inflammatory cytokines,~     thereby regulating the hyperplasia of epidermis induced by Th1/Th17 related cytokines.~   "
113008|NCT02088268|"~     The purpose of this study is to focus on the effect of platelet-rich-plasma on diabtic ulcer~     foot, as adjuvant treatment along with the standard care of chronic diabetic, and evaluate~     the efficiency and the clinical application of PRP on serious wound healing.~   "
113009|NCT02088255|"~     The purpose of this study is evaluate the effects of walking training with partial body~     weight support on static (floor) and dynamic (treadmill) surfaces in individuals with~     hemiparesis due to stroke. For this purpose, two training protocols will be employed in three~     experimental groups: G1 will do the walking training with partial body weight support on~     static surfaces and G2 will do the walking training with partial body weight support on~     dynamic surfaces~   "
113010|NCT02088242|"~     Exposure to heat stress can compromise the physiological and cognitive function and be life~     threatening, particularly in a military setting. Various strategies of precondition to heat~     stress that have been explored in the past proved to be inapplicable. We aim to examine the~     influences of Astaxanthin supplementation as a preconditioning strategy to heat stress in a~     human model using a heat tolerance test. This will be achieved by a double-blind, placebo~     controlled supplementation trial, exposing human subjects, before and after consuming~     Astaxanthin or a placebo, to a controlled heat strain environment, while performing moderate~     exercise in a heated chamber.~   "
113011|NCT02088229|"~     This longitudinal interventional case series will utilize the patients at the University of~     Michigan W.K. Kellogg Eye Center scheduled to begin treatment for diabetic macular edema.~     Baseline measures will be taken which include structural assessments such as circulatory~     capacity utilizing fluorescein angiography, in addition to retinal layer integrity and~     thickness using high resolution optical coherence tomography. Also, functional assessments~     such as visual acuity, contrast sensitivity, photostress recovery, dark adaptation,~     perimetry, and cellular fluorescence will be tested. Adverse events will be recorded and~     compared with historical controls to ensure that currently accepted interventions are safe.~     Finally, potential confounding variables for DME including those related to the eye, systemic~     factors, and patient demographics will be recorded to assess the influence of these variables~     on treatment response.~      The primary objective is to develop hypotheses that might better explain the retinal~     structural (anatomical) and/or functional (physiological) mechanisms of visual impairment in~     eyes receiving treatment for diabetic macular edema (DME).~   "
113012|NCT02088216|"~     Objective: To evaluate whether long-term oral N-acetylcysteine as an expectorant drug can~     reduce the frequency of acute exacerbations of patients with non-cystic fibrosis~     bronchiectasis and improve their quality of life.~      Methods: Patients with non-cystic fibrosis bronchiectasis will be randomly assigned to the~     observer group (participants receive 600 mg of oral N-acetylcysteine BID for 12 months) or~     the control group (participants receive oral tablet BID for 12 months). The primary endpoint~     was the frequency of acute exacerbations.~      Expected results: Compared with the control group, the frequency of acute exacerbations of~     the observer Group will decrease significantly.~      Hypothesis: Long-term oral N-acetylcysteine can reduce the frequency of acute exacerbations~     of patients with non-cystic fibrosis bronchiectasis and improve their quality of life.~   "
113013|NCT02088203|"~     Safety and tolerability of a soy-protein Russian Tarragon complex versus a placebo.~   "
113014|NCT02088190|"~     The investigators hypothesize that the improvements in insulin sensitivity, beta (β)-cell~     function, and inflammation will be greater, and the improvement in sarcopenic obesity will be~     less, in younger versus older individuals after substantial weight loss induced by sleeve~     gastrectomy bariatric surgery.~   "
113015|NCT02088177|"~     This is an 8 week, outpatient research study testing the use of long-acting naltrexone~     (Vivitrol) as a treatment for marijuana dependence. Vivitrol is a medication that is~     effective in treating dependence on opiates and opioids, and in treating dependence on~     alcohol. It is FDA approved for these disorders. It is a long-acting medication that contains~     enough medicine in each injection to last for one month. One way it works is by blocking the~     effects of opiates, including opiates released by the body in response to drugs and alcohol.~     In this study, we are interested in testing the effects of Vivitrol in people with marijuana~     dependence.~      Individuals participating in this study will receive two Vivitrol injections, each given four~     weeks apart, (week 1 and week 5). The injection is given in the muscle of the buttock on one~     side. Participants will attend clinic visits two times a week during this 8-week study for~     medical management for drug use and for monitoring of physical and psychological health.~   "
113016|NCT02088164|"~     To determine the long-term survival outcome of subjects who had various PSA levels at~     screening~   "
113042|NCT02087826|"~     The purpose of this research study is to examine whether specific genes (e.g. SLC16A11)~     affect how human beings respond to food and a medication that is commonly used to treat type~     2 diabetes. The food the investigators will be studying is specially prepared to contain~     protein, carbohydrate, and fat. The drug the investigators are studying is metformin. The~     investigators hypothesize that physiological responses to the meal and to the medication will~     differ between carriers and non-carriers of genes associated with type 2 diabetes.~   "
113043|NCT02087813|"~     Neuromyelitis Optica (NMO) is a rare, devastating demyelinating disease of the central~     nervous system (CNS) that has different causes and treatments from the more common~     demyelinating disease multiple sclerosis (MS). Current NMO therapies are nonspecific and have~     varying and often suboptimal benefit. The investigators will evaluate whether use of~     alpha1-antitrypsin (A1AT, an FDA-approved medication for patients with congenital deficiency~     of A1AT associated with emphysema) can benefit acute attacks of NMO, improving patient~     disability and quality of life.~   "
113017|NCT02088151|"~     Laser photocoagulation of the retina targeting the outer layers is an established therapy for~     proliferative retinopathy and macular edema from diabetic microangiopathy or retinal vein~     occlusion, centrals serous retinopathy, and extrafoveal subretinal neovascular membranes.~     However, collateral damage occurs and scotomas can result when using conventional lasers with~     pulse duration of 100ms and more. This is particularly relevant for laser treatments of the~     macula where the main therapeutic effect results from stimulation of the retinal pigment~     epithelium cells and photoreceptor damage is thought to be an unnecessary side effect. Recent~     experimental research with new laser devices using much shorter pulse duration has shown that~     photoreceptor damage can be greatly reduced and the retinal pigment epithelium selectively~     targeted, hence the term selective retinal pigment epithelium laser therapy (SRT).~     Investigators hypothesize that SRT is equally effective as standard laser photocoagulation~     for macular disease but minimizes local visual field defects.~      In this study, patients with central serous retinopathy, macular edema from diabetic~     microangiopathy or branch vein occlusion, and non-exudative age-related macular degeneration~     will be treated with SRT. Patients will be assessed 1, 3 and 6 months after treatment.~   "
113018|NCT02088138|"~     The purpose of this study was to determine the effects of Functional Electrical Stimulation~     (FES) on physical performance and quality of life of patients in cardiac rehabilitation.~   "
113019|NCT02088125|"~     The purpose of the study was to analyze the effect of IS and BS on dynamics ventilatory and~     asymmetry of the chest wall in patients after stroke .~   "
113020|NCT02088112|"~     This a Phase I, Open-Label, Multicentre Study to assess the safety, tolerability,~     pharmacokinetics and preliminary anti-tumour activity of gefitinib in combination with~     MEDI4736 (anti PD-L1) in Subjects with Non-small cell lung cancer (NSCLC). The study consists~     of two phases: Escalation phase and an expansion phase to be conducted in locally advanced or~     metastatic NSCLC subjects~   "
113021|NCT02088099|"~     Mayo Clinic has been funded by the National Institute on Disability Independent Living &~     Rehabilitation Research (NIDILRR) as a Traumatic Brain Injury (TBI) Model System Center~     continuously since 1998. We have successfully competed for this funding because we~     consistently produce high quality research and because we provide comprehensive team-based~     rehabilitation services to people with TBI and their families over the continuum of care that~     is associated with superior outcomes.~      Lack of access to specialized TBI care is the most common need identified by individuals~     after they are hospitalized for TBI. The upper Midwest has some of the highest populations of~     rural dwellers, the elderly, and Native Americans, all of whom have a high risk for TBI and~     are more likely to have limited access to rehabilitation services after acute care. Explosive~     advances in communication technology have brought tele-medicine to the forefront of health~     care. The CONNECT trial will test the effectiveness of using modern technologies - such as~     phone consultation and other telehealth communication systems - to deliver specialized brain~     rehabilitation resources remotely to patients and providers in the upper Midwest. The groups~     targeted by the CONNECT trial are:~        -  Individuals recently hospitalized with TBI;~        -  Their families;~        -  Their local health care and other providers (primary care providers, psychologists,~          therapists, social service providers, job counselors).~      The CONNECT trial is the first study of this scope - in 4 upper Midwest states (MN, IA, ND,~     and SD), 3 health systems (Mayo Clinic, Altru Health System in ND, Regional Health in SD),~     and 2 state Departments of Health (IA, MN) - using electronic technology to see if outcome~     can be improved by providing care with no face-to-face contact. The trial will study whether~     outcomes over three years are different in the group receiving this remotely provided model~     of care compared to a matched group that receives usual care in their communities.~      The desired long term outcome of this study is to increase our capacity to provide care and~     to reduce barriers to accessing specialized TBI rehabilitation services faced by individuals~     with TBI and their families.~   "
113022|NCT02088086|"~     The Fit Study is a three-year, cluster-randomized controlled trial that will evaluate the~     impact of school-based body mass index (BMI) screening and reporting on child health.~     Seventy-nine California schools will be randomized to one of three groups: 1) BMI screening~     and reporting, 2) BMI screening, and 3) no BMI screening or reporting (control).~     Investigators will assess the impact of BMI reporting on students' BMI trajectories over~     three years. Investigators will also assess the impact of BMI screening on weight-based~     teasing, feelings of stigmatization, and weight-control behaviors among students.~   "
113023|NCT02088073|"~     It is hypothesized that ZS is more effective than placebo control (alternative hypothesis) in~     maintaining mean double-blind randomized maintenance phase (DBRMP) Day 8-29 serum potassium~     levels (3.5 - 5.0 mmol/l, inclusive) among hyperkalemic subjects in whom normokalemia was~     established during the open-label acute phase versus no difference between each ZS dose~     (highest to lowest) versus placebo control (null hypothesis).~   "
113024|NCT02088060|"~     Schizophrenia is a heterogeneous mental disorder that affects one percent of the world's~     population. Current antipsychotics are only partially effective, and their use is often~     associated with serious side effects. Cannabidiol is a natural counterpart of the~     psychoactive component of marijuana, delta-9-tetrahydrocannabinol. While cannabidiol has no~     psychotomimetic or addictive properties, it indirectly affects endogenous cannabinoid~     signalling by impairing the degradation of the endocannabinoid anandamide. In a controlled~     clinical trial of cannabidiol versus amisulpride (an established antipsychotic) in acute~     paranoid schizophrenics the investigators showed a significant clinical improvement in all~     symptoms of schizophrenia compared to baseline with either treatment. But cannabidiol~     displayed a significantly superior side-effect profile. This study is to evaluate the~     efficacy and safety of this novel treatment option in comparison to placebo and olanzapine,~     an established second generation antipsychotic in the treatment of acute schizophrenia and~     schizophrenia maintenance therapy, in a four-week clinical trial.~   "
113025|NCT02088047|"~     This study is designed to pilot an intervention technique to reduce the self-stimulating~     behaviors seen in individuals with autism spectrum disorders using intervention with~     ProFoveate pellets. Self-stimulating behaviors like hand flapping, eye blinking, and rocking,~     can interfere with the individual's ability to interact with their peers. Participants will~     wear the pellets for four week and measures with taken again. Another group of participants~     will not get the pellets. Both groups will be tested at the beginning and end of the study.~     Any variations in self-stimulating behaviors will be documented through parent report,~     Observational data. The investigators hypothesize that they will see changes in self-~     stimulating behaviors as a result of the strategic placement of the ProFoveate™ pellets on~     the ears of one group of the participants.~   "
113026|NCT02088034|"~     The overarching goal of this project is to develop and test a behavioral intervention~     delivered by promotoras to help at-risk Latinas lose weight and prevent diabetes.~   "
113027|NCT02088021|"~     The purpose of this clinical investigation is to evaluate the use of the Portico ALC Delivery~     System to place a transcatheter aortic valve through an alternative access site, specifically~     subclavian/axillary or TAo.~   "
113030|NCT02087982|"~     The comprehensive geriatric assessment (CGA) is a multidimensional, interdisciplinary~     diagnostic process to determine the medical, psychological, and functional capabilities of an~     elderly person, in order to develop a coordinated and integrated plan for treatment. It~     represents the first stage of the most appropriate care for elderly people who are frail or~     who cannot perform at least three daily tasks unaided.~      It has been shown that the integration of CGA in the decision-making and care management at~     hospital improves inpatient's health and functional status, and reduces mortality rate and~     healthcare expenditures. The effects of CGA in daily practice of general practitioners remain~     unknown.~      Implementation of a systematic CGA for every older old community-dwellers performed by a~     general practitioner remains yet difficult because of number of issues. First, although the~     number of older old community-dwellers keeps increasing, the number of health care~     professional with geriatric skills does not. Second, CGA is a complex and time-consuming~     process. Third, CGA requires a multidisciplinary geriatric team that cannot support alone the~     care of all frail older old community-dwellers due to their limited number. An implication of~     non-geriatricians in CGA is therefore required.~      Recently, it was confirmed that CGA cannot be applied to all older adults, and that the best~     compromise could be the use of a two-step approach. The first step is the identification by~     non-geriatricians of elderly inpatients at high risk of adverse outcomes using a screening~     tool, and the second step is a CGA by geriatricians with a diagnosis purpose.~      None of existing tools used for screening is adapted to the population of elderly people who~     visit general practitioners.Thus, healthcare professionals working in ED need a simple,~     standardized and brief geriatric assessment (BGA) to identify as soon as possible frail older~     old community-dwellers requiring specialized geriatric care.~      The investigators hypothesized that a BGA older old community-dwellers carried out by a~     general practitioner could predict the adverse health events (i.e. hospitalization,~     institutionalisation, medical consultations and death) occurring during a 6-months follow-up~     period before the evaluation.~   "
113031|NCT02087969|"~     The purpose of this study is to determine the effectiveness of dry needling in improving~     ankle range of motion and functional outcomes. There have been an increasing number of~     studies on dry needling as an intervention for pain but none thus far that have studied~     functional outcome measures of the ankle. The study will include healthy male subjects~     between the ages of 18-30 years old randomized in to 3 intervention groups of: dry needling~     of the triceps surae, triceps surae stretching only, dry needling and stretching. The~     subjects who receive dry needling as an intervention will have the trigger point identified~     and dry needling performed while under musculoskeletal ultrasound visualization. The subjects~     will undergo pre and post intervention testing including Lower Quarter Y-Balance test,~     passive ankle dorsiflexion, closed chain half kneeling dorsiflexion, standing dorsiflexion,~     deep squat, multisegmental flexion as well as Marx Activity Level Scale. There will be 3 days~     between the initial testing/intervention and follow up. These outcomes will be the primary~     variables of interest. Ultrasound, Y balance testing, self stretching, and range of motion~     measurements are safe and pose no risk to the subject. Dry Needling has been found to be very~     safe and effective in the hands of physical therapists with a calculated risk of adverse~     events to be less than 0.04%.~   "
113032|NCT02087956|"~     The purpose of this study is to determine whether priority-based patient navigation will~     improve patient satisfaction, quality of life (QOL), and depression when compared to~     screening-and-referral for socioeconomically disadvantaged women's health patients with~     depression. The investigators goal is to establish patient-driven, effective, generalizable,~     and disseminable interventions to reduce depression-related disparities and improve outcomes.~   "
113033|NCT02087943|"~     A study to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with~     moderate to severe atopic dermatitis~   "
113034|NCT02087930|"~     Food allergy (FA) derives from a dysregulation of oral tolerance mechanisms. Studies suggest~     a crucial role for enteric microflora in oral tolerance development. An altered composition~     of intestinal microflora results in an unbalanced local and systemic immune response to food~     allergens. There are qualitative and quantitative differences in gut microbiota composition~     in children with food allergy. These findings support the concept that specific beneficial~     bacteria from human intestinal microflora, designated probiotics, could restore intestinal~     microflora homeostasis and prevent or treat FA.~   "
113035|NCT02087917|"~     To determine the efficacy of HS-25 (5, 10, 20 or 30 mg) in reducing low density~     lipoprotein-cholesterol (LDL-C) levels after a 4-week period of treatment in adults with~     primary hypercholesterolemia.~   "
113036|NCT02087904|"~     A Phase 2a, multicenter, randomized, double-blind, parallel group, placebo-controlled study~     to evaluate the safety, tolerability, efficacy and pharmacokinetic/pharmacodynamic effect of~     ABT-981 in patients with symptomatic, radiographic, and inflammatory knee osteoarthritis.~   "
113037|NCT02087891|"~     Psychosocial stress increases the risk for a multitude of diseases, including obesity,~     hypertension, and cardiovascular disease. Stress may also result in increased utilization of~     health care services. In the workplace, stress leads to emotional exhaustion, job~     dissatisfaction, lower productivity and impaired performance. Stress management programs and~     those based on mindfulness meditation have gained popularity in recent years. The purpose of~     this study is to evaluate the feasibility of an 8-week web-based mindfulness stress reduction~     program and its effectiveness in reducing work related stress and improving well-being in a~     large corporate call center.~   "
113038|NCT02087878|"~     To collect and store blood and biopsy samples obtained from CD or UC patients exposed to~     adalimumab and diagnosed with Hepatosplenic T-cell Lymphoma (HSTCL), for the purpose of~     identifying potential biomarkers and genetic mutations in patients who have developed HSTCL.~   "
113039|NCT02087865|"~     This 24-week study will examine the sensitivity of functional MRI to detect brain changes~     caused by donepezil HCL (a cholinesterase inhibitor) in healthy older adults at genetic risk~     for Alzheimer's Disease. Participants with a family history of Alzheimer's Disease will be~     eligible for this study. Participants without a family history of AD will also be enrolled to~     serve as a control group.~   "
113040|NCT02087852|"~     This registry will help us develop better methods of:~        -  Preventing these cancers~        -  Diagnosing these cancers~        -  Treating these cancers~   "
113041|NCT02087839|"~     Primary Objectives:~        -  To assess the safety of oral therapy with ZD6474 by evaluating the frequency, severity,~          and duration of treatment-emergent adverse events in patients with poor prognosis lung~          cancer.~        -  To record the extent, frequency and duration of any tumor responses to this treatment~          regimen and assess whether ZD6474 augments the efficacy of radiation therapy in~          non-small cell lung cancer patients.~        -  To determine the recommended phase II dose of ZD6474 for future clinical studies with~          radiation therapy.~      Secondary Objectives:~        -  To determine the effects on metabolism and angiogenic factors by positron emission~          tomography (PET) scan/computed tomography (CT) scan , Vascular endothelial growth factor~          (VEGF), and circulating endothelial cell levels in patients treated with ZD6474 and~          radiation therapy.~   "
113045|NCT02087787|"~     The goal of this study is to develop and test the effects of a marrow transplant (BMT) Legal~     Clinic established through a medical-legal partnership (MLP) in an adult blood and marrow~     (BMT) transplant setting. This will be a 2-arm randomized, controlled clinical trial, in~     which the intervention group of patients will participate in a BMT Legal Clinic and the~     control group is provided standard information regarding legal resources.~   "
113046|NCT02087774|"~     The investigators hypothesized that the addition of 6 minutes of exercise during the school~     day would increase physical fitness in elementary school students as demonstrated by longer~     distances run in 2 minutes and a decrease in heart rate at the end of the exercise.~   "
113047|NCT02087761|"~     The ARIES Flu Assay is a real-time PCR based qualitative assay for the direct detection and~     differentiation of respiratory viral nucleic acid in nasopharyngeal swabs specimens.~      The objective of this study is to establish the diagnostic accuracy of ARIES Flu Assay.~   "
113048|NCT02087748|"~     The purpose of this study is to evaluate analgesic efficacy of Topical Voltaren Gel~     (diclofenac sodium gel) 1% applied QID compared to Placebo in Subjects Experiencing Delayed~     Onset Muscle Soreness.~   "
113049|NCT02087735|"~     The purpose of this cross over pilot study is to investigate the urinary catabolites of~     Proanthocyanidines (PACs) as biomarkers of cranberry extracts in healthy young women.~   "
113050|NCT02087722|"~     KI1001(Circadin®, Prolonged release tablet which contains melatonin) has showed its efficacy~     to improve sleep quality in over 55 years old primary insomnia patients. This is a 2nd~     bridging study to investigate the efficacy and safety of KI1001(Circadin®) in Korean~     patients.~   "
113051|NCT02087709|"~     The purpose of this study is to evaluate the effect of a hypocaloric diet on biomarkers~     associated with insulin resistance, metabolic profile and body composition in women with~     Metabolic Syndrome.~   "
113052|NCT02087696|"~     The purpose of this project is to evaluate the efficacy of Tocilizumab (TCZ) given as~     monotherapy in patients with active rheumatoid arthritis (RA) according to EULAR response at~     24 weeks after treatment initiation.~      The study design is an intervention study, uncontrolled, multicenter, prospective, 32-weeks,~     two cohorts of patients with poor compliance or with any contraindication or intolerance to~     methotrexate.~      One cohort naive to previous biological therapy and the other one treated previously with a~     biological treatment.~   "
113053|NCT02087683|"~     The purpose of this study is to determine the effects of vitamin D supplementation in~     patients with heart failure and vitamin D deficiency on ventricular function, inflammatory~     cytokines, brain natriuretic peptide, lipid profile, glucose, serum insulin, serum~     parathyroid hormone and calcium.~   "
113054|NCT02087670|"~     Evaluate pro-BNP levels, oxygen consumption, functional class, and quality of life in~     patients with chronic heart failure after participating in an exercise program and compare~     them baseline and 2 months, with another group who underwent an educational program.~   "
113055|NCT02087657|"~     By doing this study, researchers hope to learn the following:~        -  The safety of hyperbaric oxygen administration in the setting of the autologous~          transplant~        -  The effects of hyperbaric oxygen administration on neutrophil count recovery and~          engraftment~   "
113056|NCT02087644|"~     A phase IIb study in patients to evaluate CYT003- QbG10 versus placebo, in patients with mild~     to moderate allergic asthma not sufficiently controlled on inhaled steroid.~      Altogether 170 patients, randomized to two treatment groups will be included. Key outcome~     measures are patient reported parameters on their asthma~   "
113057|NCT02087631|"~     Study Purpose:~      The purpose of this clinical trial is to determine if extended-release quetiapine in a dose~     of 300 mg daily is tolerable to people with relapsing remitting and progressive MS. The~     investigators will also determine if the investigators can increase the dose up to 300 mg~     daily within 3 days in people with relapsing remitting MS and within 2 weeks in people with~     progressive MS. The investigators will determine if at least two thirds of study participants~     tolerate the drug well enough to continue it for 4 weeks. Tolerance will be determined~     separately for people with relapsing remitting and progressive MS. People with progressive MS~     may be less tolerant of side effects because of greater underlying brain injury from MS.~     Alternatively, people with progressive MS may gain more benefit from the improved sleep that~     usually occurs with use of quetiapine or they may be more willing to tolerate some side~     effects. This clinical trial will determine the maximally tolerated dose for future trials of~     this drug.~      The number of participants in this study will depend on the tolerability at each dose tested.~     A maximum of 18 people with relapsing remitting MS and 18 people with primary or secondary~     progressive MS will be included.~      Study Design:~      The cohort expansion design (3+3) is used to determine toxicity-based dosing. This design is~     used in oncology phase I trials as it is guided by patient safety and minimizes the number of~     participants exposed to toxicity (Ivy et al. 2010). Maximum toxicity is defined as 33% or~     less. In this model, three patients will comprise the initial cohort. In the absence of DLT~     treatment may be escalated to the next higher dose in the next group of three patients.~     However, if one of three patients reaches DLT the cohort is expanded to six patients to~     verify that the toxicity rate has not exceeded or reached 33%. When the toxicity rate exceeds~     or reaches 33% in a cohort, this dose is deemed the maximum administered dose and a lower~     dose will be used in the next group of three patients. Patients with RRMS and progressive MS~     will be evaluated in separate groups using different dose schedules.~   "
113058|NCT02087618|"~     This is a pilot study to examine the feasibility of a formal 30-minute daily program on a~     tablet computer (simply a tablet) in subjects with mild cognitive impairment (MCI). The~     purpose of the program, known as Kodro Solution, is to increase physical activity, maintain~     social interaction, improve nutrition and exercise cognitive skills using a tablet. In~     addition to feasibility, outcome measures will include: (a) health-related quality of life,~     (b) self-esteem, (c) activities of daily living, (d) socialization, (e) mood, and (f)~     cognition. Study participants must have a study partner who can assist them with training on~     use of the tablet and the Kodro Solution program.~      Fifty (50) study subjects and their study partners will be recruited at the Wien Center. A~     delayed start design will be utilized. Study subjects will be randomly assigned to either~     active treatment (Kodro+) or delayed treatment (Kodro+D). Active treatment with Kodro~     Solution will be initiated at the baseline visit for Kodro+ subjects and 12 weeks after~     baseline for Kodro+D subjects. The 12-week period without tablets will serve as a control.~     Active treatment with Kodro Solution will continue for 36 weeks for the Kodro+ subjects and~     24 weeks for the Kodro+D subjects. For both groups, the outcome measures will be assessed at~     baseline, week 12 and week 36. The lagged design will facilitate enrollment and enable the~     assessment of a dose effect.~   "
113075|NCT02087397|"~     This will be an open-label, non-randomized, multi-center, patient sponsored study of~     Adipose-Derived Stromal Vascular Fraction cells (AD-SVF) implantation delivered into the~     corpus cavernous in patients with Erectile Dysfunction.~      The intent of this clinical study is to answer the questions: 1) Is the proposed treatment~     safe and 2) Is treatment effective in improving the disease pathology of patients with~     diagnosed Erectile Dysfunction.~   "
113059|NCT02087605|"~     The objective of this work is the development and validation (reliability and validity) of~     the Automatic image analyzer to assess it retinal vessel caliber (ALTAIR) platform to analyze~     and validate its utility in different clinical settings.~      Methods / Design Design : In the first phase , will be a cross- sectional study and a second~     phase will be a prospective observational study with annual follow-up for 4 years. The study~     will be conducted in primary care including 386 subjects. Main measurements: blood pressure,~     carotid intima-media thickness using carotid ultrasound , central blood pressure and wave~     velocity pulse by SphygmoCor system, Cardio-ankle vascular index (CAVI) by VASERA® VS1500 ,~     evaluation of hypertrophy ventricular using a digital ECG and renal injury . Retinal vascular~     evaluation will be done by a non-mydriatic TOPCON TRCNW200 getting focused papilla, nasal and~     temporal and developed by software images automatically calculate the thickness of the~     retinal vessels , the arteriovenous index, the vascularized area and branching pattern . For~     validation software retina intra and inter - observer variability , the correlation of the~     tool measurement with AVindex , and concurrent validity with parameters of vascular structure~     and function and target organ damage and association analysis will analyze the different~     parameters of the estimated retina and evolution or appearance of new lesions in the target~     organs.~      Discussion The validation of the tool contribute to the analysis of retinal vessels improved~     reliability by reducing the intervention of the observer and further validate the use of more~     information than the previously used , especially surface vascularization and vessel~     branching patterns .~   "
113060|NCT02087592|"~     BRCA1/2 mutation carriers have a considerably increased risk to develop breast and ovarian~     cancer during their lifetime. There is evidence from the literature that for sporadic breast~     cancer disease risk and the course of disease can be significantly influenced by physical~     activity, nutrition and weight. The hypothesis of this 3 year, prospective randomized~     multicenter feasibility trial is that a structured life-style intervention program with~     exercise training and mediterranean diet is feasible and improves the nutritional and fitness~     status as well as the weight, the quality of life and stress reacting capacity.~   "
113061|NCT02087579|"~     The purpose of this study is to gather information about the steady-state plasma~     concentrations of aripiprazole, olanzapine, quetiapine and their relevant metabolites, at~     various dose levels and at different time points after dosing. In addition, comparison of~     capillary drug concentrations vs. venous drug concentrations will be performed for~     aripiprazole, olanzapine, paliperidone, quetiapine, risperidone and their relevant~     metabolites.~   "
113062|NCT02087566|"~     Renal failure patients were treated with linezolid (LZD) for proven or suspected infections~     by multiresistant Gram-positive cocci. The aim of this study is to determine if dose~     adjustment of LZD is needed as a function of renal impairment or not, especially that a~     significant component of LZD is eliminated unchanged in urine.~   "
113063|NCT02087553|"~     The investigators hypothesize that the storage-damaged red cells are responsible for some of~     the adverse effects of transfusion. In this observational study, the investigators will~     measure various laboratory parameters both before and after transfusion in a pediatric~     intensive care unit to determine at what duration of storage is there laboratory evidence of~     refrigerator storage damage.~      The investigators hypothesize that increasing storage time of packed red blood cells (PRBCs)~     transfused will be associated with increasing non-transferrin-bound iron (NTBI),~     pro-inﬂammatory cytokine concentrations, and enhanced microbial growth in vitro in pediatric~     patients.~   "
113064|NCT02087540|"~     To identify efficacy and safety of Telmisartan/Rosuvastatin co-administration in~     hyperlipidemia control in hypertensive patients with hyperlipidemia compared to each~     monotherapy.~   "
113065|NCT02087527|"~     The aim of this study is to evaluate the efficacy of addition of corticosteroid therapy to~     antibiotic treatment during the first 48 hours of admission to the hospital in patients with~     cellulitis and its impact in the duration of the stay.~   "
113066|NCT02087514|"~     This study will determine the minimal duration of red blood cell (RBC) storage that leads to~     increases in circulating non-transferrin-bound iron in healthy human volunteers~     post-transfusion. The results from this study will help guide national guidelines for~     appropriate duration of RBC storage prior to transfusion, which is currently 6 weeks by Food~     and Drug Administration (FDA) criteria. The overall objective of this research is to improve~     the safety of refrigerated storage of red blood cells before transfusion.~   "
113067|NCT02087501|"~     Clinical Investigation Design A prospective, open-label, non-randomized, interventional~     clinical study, sponsored by Endospan Ltd. Patients will be followed-up for five years.~      Investigational Device The Horizon™ Abdominal Aortic Aneurysm Stent Graft System and its~     designated Delivery System.~      Purpose The purpose of the study is to evaluate the safety and performance of the Horizon™~     AAA Stent Graft System for the treatment of infrarenal abdominal aortic and/or aortoiliac~     aneurysms. The results of this study will be used as supportive data for CE Marking~     submission in the European Union (EU).~      Objectives The primary objectives of the study are to evaluate the safety and performance of~     the Horizon™ AAA Stent graft System.~      Primary End Points Safety endpoints include proportion of patients free from device related~     Major Adverse Events (MAEs) within 1 month of the endovascular procedure. Performance~     endpoints include successful delivery and deployment of the device; and absence of the~     following at 1 month follow-up: aneurysm growth ≥5mm, type I or III endoleaks, stent graft~     occlusion, conversion to open surgery, rupture and stent graft migration.~      Subject population Thirty (30) patients having infrarenal abdominal aortic and/or aortoiliac~     aneurysms, having Iliac/femoral access vessel morphology that is compatible with vascular~     access techniques and devices.~      Treatment All patients will be treated by implantation of the Horizon™ Abdominal Aortic~     Aneurysm Stent graft System.~   "
113068|NCT02087488|"~     This double-blind RCT will evaluate the therapeutic effectiveness and safety of auricular~     acupuncture(AA) for primary insomnia(PI) .~   "
113069|NCT02087475|"~     Colorectal cancer (CRC) is one of the most leading causes of cancer death in China. Although~     multiple treatment modalities including surgery, radiotherapy and chemotherapy have been~     developed, the prognosis of advanced CRC still remains poor. While around 30% of resectable~     advanced CRC could be cured. This study is designed to compare perioperative FOLFIRI versus~     adjuvant FOLFIRI in resectable advanced CRC who exposed to oxaliplatin in open-label, phase~     III mode.~   "
113079|NCT02087345|"~     Dental erosions, the chemical dissolution of enamel without bacterial involvement, are~     considered to be an established complication of gastroesophageal reflux disease (GERD) by the~     Montreal global consensus statement. Given the high prevalence of dental erosions and the~     absence of any pH-impedance data or medical management guidelines for GERD-associated dental~     erosions, reflux characteristics will be characterized using questionnaires, endoscopy and~     esophageal pH-impedance testing, in successive patients dental erosions referred by dentists~     for evaluation of GERD. For assessment of the role of additional factors besides H+ activity~     in the refluxate, a sample of gastric juice will be aspirated during endoscopy and frozen for~     analysis of pepsin and other proteases. Prognostic factors for progression of dental erosions~     will be determined by repeating the evaluation after chronic dosing with esomeprazole 20mg~     twice-daily, which is prescribed to all patients.~   "
113080|NCT02087332|"~     Study hypothesis is that the time from randomization to the increase of natriuresis (%), time~     to standardization of natriuresis daily profile, blood pressure profile and the percentage~     reduction of central hemodynamic parameters will be relatively changed over the study period~     by more than 15%.~   "
113081|NCT02087319|"~     The purpose of study is to examine the advantage of PRP on hair loss and male pattern~     baldness. The investigators will inject PRP into the scalp regions where with little or no~     hair, and evaluate the effect and efficiency of PRP on human hair growth.~   "
113082|NCT02087306|"~     This is a multicenter study of Brincidofovir (CMX001) (BCV) administered twice weekly (BIW)~     for the treatment of AdV infection detected during asymptomatic AdV viremia or during~     symptomatic AdV infection. After completing a screening assessment to confirm study~     eligibility, all enrolled subjects will undergo a treatment period of 12 weeks. Beginning on~     Day 1, adult (≥ 18 years) and adolescent (13-17 years) subjects weighing > 50 kg will receive~     BCV 100 mg BIW; children up to 12 years of age will receive weight-based doses of 2 mg/kg~     BIW, not-to-exceed a total dose of 200 mg/week.~   "
113083|NCT02087293|"~     Specific Aim 1: To develop a patient-reported, EHR-integrated system to actively monitor the~     safety and effectiveness of treatment for patients taking FDA-approved medications for one of~     four common chronic conditions (diabetes, hypertension, insomnia, depression), with~     integrated management support by a pharmacist.~      Specific Aim 2: To measure the reach, effectiveness, adoption and implementation of this~     integrated module for adult primary care patients in the Brigham and Women's Primary Care~     Practice-Based Research Network.~   "
113084|NCT02087280|"~     After discharge from inpatient treatment, 30-50% of patients with Anorexia Nervosa require~     re-hospitalization within 4-12 months. So far, high relapse rates are mostly considered as~     lack of the patient's compliance and motivation to recover. However in studies, psychological~     relapse predictors explain only a minor part of the variance in relapse risk. Metabolic~     phenotyping has clinical value to predict weight course in obese patients and we assume that~     it could also be clinically relevant in patients with AN. We hypothesize that in patients~     with a dissipative but not with the thrifty phenotype, positive energy balance during~     refeeding causes an over proportional rise in energy expenditure, counteracts continuous~     weight gain during inpatient treatment, and increases relapse risk within one year after~     discharge. Thus we believe that metabolic phenotype as a biological parameter has prognostic~     value for the disease course in AN.~   "
113085|NCT02087267|"~     The objective of the PMCF is to collect outcome information on patients suffering from~     symptomatic degenerative disc disease or degenerative spondylolisthesis requiring 1- or~     2-level lumbar or lumbar-sacral spinal fusion with posterior instrumentation and therefore~     receiving the icotec CF/PEEK Pedicle System in combination with the icotec CF/PEEK TLIF Cage~     ETurn™.~   "
113086|NCT02087241|"~     The aim of this study is to combine AZD1775 with standard front-line chemotherapy in subjects~     with advanced NSCLC.~   "
113087|NCT02087228|"~     The purpose of this study is to evaluate the shape, size and appearance of the inside of the~     uterus six months following an endometrial ablation procedure. Half of the participants will~     have their ablation performed with a hydrothermal ablation device and the other half will~     have their ablation performed with a device that uses radiofrequency energy.~   "
113088|NCT02087215|"~     Boron as a naturally occurring element has some metabolic and inflammatory actions. The~     antibacterial activity against gram negative bacteria is also known. Boron deficiency is~     shown to be related with impaired wound bone healing in rats. Therefore, special wound care~     formulas containing boron may have some positive effect on wound healing of the patients with~     diabetic foot ulcers.~   "
113089|NCT02087202|"~     NMDA receptor is administered and postoperative remote hyperalgesia is investigated.~   "
113090|NCT02087189|"~     This clinical investigation is designed to confirm the safety and efficacy of the TD01 ICD~     lead.~   "
113091|NCT02087176|"~     A Lead-in Phase II Multicentre, Randomised, Double-Blind Study Comparing AZD1775 plus~     antimitotic agent and Placebo plus an antimitotic agent in Previously Treated Non-Small-Cell~     Lung Cancer Patients~   "
113092|NCT02087163|"~     The purpose of this study is to use clear aligners to measure tooth movement and length of~     treatment.~   "
113093|NCT02087150|"~     The objective of this study is to determine whether Eustachian tube dilation in conjunction~     with medical management or medical management alone is effective for treating Eustachian tube~     dysfunction.~   "
113102|NCT02087033|"~     it is a prospective, randomized, double-blinded, crossover study on the use of an association~     of omega 3 fatty acids, astaxanthin, vitamin E and hawthorn (ritmonutra) in subject affected~     by symptomatic supraventricular ectopic beats without structural heart disease.~      The study will evaluate the reduction of the number of supraventricular ectopic beats and~     symptoms related.~   "
113103|NCT02087020|"~     Introduction: Periprosthetic joint infection (PJI) is a common cause for reoperation after~     knee and hip arthroplasty surgery. Debridement, antibiotics and implant retention (DAIR) is~     recommended in early infections (< 4 weeks) and stable implants. Aims: To define the success~     rate of DAIR in early infections and to identify predictors for success. Material and~     methods: In a retrospective cohort study we included patients with hip- or knee~     arthroplasties reoperated for an early PJI at Danderyd Hospital 2007-2012. Logistic~     regression analysis was used to identify risk factors affecting success rate. Primary outcome~     variable was the success of the DAIR treatment. Secondary outcome variable vas risk factors~     for treatment failure.~   "
113094|NCT02087137|"~     Normal aging is associated with decline in some aspects of memory, and this can be a risk~     factor for reductions in everyday functioning. The Baycrest Memory and Aging Program teaches~     positive adaptation to age-related memory changes, including strategies for minimizing the~     everyday impact of normal memory change and positive lifestyle change to maximize brain~     health. Prior research has shown that the Memory and Aging program is effective in increasing~     participants' knowledge about memory, use of memory strategies, and confidence in memory~     function, as well as adoption of healthier lifestyle practices and reduction in intention to~     use unneeded health care resources.~      Although not one of the stated goals of the program, informal feedback from participants~     suggests that the educational content and skills training in the Memory and Aging Program has~     led some participants to change behaviours in ways that lead to significant improvements in~     their everyday functioning. For example, graduating participants often volunteer examples of~     how they have applied what they have learned to succeed in everyday memory tasks such as~     learning a new name or keeping track of future plans. Based on this participant feedback, it~     is hypothesized that the knowledge, skills, and confidence gained by Memory and Aging Program~     participants may lead to positive behaviour changes that, in turn, lead to improved everyday~     functioning. The present study will test this hypothesis using a randomized controlled~     pretest-posttest design.~   "
113095|NCT02087124|"~     Cardiovascular disease (CVD) is one of the most important and frequent causes of death.~     Postprandial lipidemia (PPL) is an independent risk factor for CVD, besides the traditional~     risk factors e.g. hypertension, high LDL-cholesterol, family disposition of CVD and type 2~     diabetes (T2D). A high PPL is associated with an increased risk of myocardial infarction and~     stroke. Reduction of increased PPL, as a part of CVD prevention, is therefore pivotal.~     Especially in groups with increased risk of CVD, like the metabolic syndrome (MeS) and T2D.~     Identification of a simple diet-related method will possibly result in reduction of CVD in~     healthy as well as high-risk subjects.~      The aim of this project is to investigate if there is a dose-response effect of whey protein~     consumed as pre-meal prior to a fat-rich meal on responses of triglycerides and~     apolipoprotein B48 (ApoB48). Secondarily the aim is to study the responses of glucose,~     insulin, glucagon, amino acids, inflammatory markers, incretins, rate of gastric emptying and~     metabolomics. Also satiety feeling will be measured.~      Investigators hypothesize that whey protein (10 or 20g) consumed 15 minutes prior to a~     fat-rich isocaloric meal reduces triglyceride- and ApoB48 responses more and in a~     dose-dependent way compared to placebo (water) consumed prior to the meal in subjects with~     MeS.~      The investigators research will hopefully contribute to a better understanding of how PPL can~     be modified in a simple manner. It will promote innovation to the food industry for~     development and production of healthy food products, which can be applied in the fight~     against CVD in the background population in general and high-risk people in particular. Thus,~     the results of this project can impart knowledge of great importance both to the national and~     international food industry as well as the healthcare systems.~   "
113096|NCT02087111|"~     Patients with genotype 3 hepatitis C who have advanced liver disease (cirrhosis) have a very~     high chance of developing fatal complications of their disease unless they receive effective~     treatment. Unfortunately the best drugs that are currently available to treat genotype 3~     hepatitis C (pegylated interferon and ribavirin) only work in about 50% of patients with~     advanced liver disease and therefore a large number of patients who have failed treatment are~     waiting for new, better drugs. Currently there are no treatments available for these~     patients. Telaprevir is a new drug that is licensed to treat genotype 1 hepatitis C and which~     works very well in these patients. In patients with genotype 3 hepatitis C small scale trials~     and laboratory studies show that some patients do respond quite well and others respond a~     little bit when given telaprevir. In patients who have exhausted all other treatment options~     the investigators speculate that telaprevir treatment may help some patients by clearing~     their infection. The purpose of this study is to see if telaprevir can help these patients~     and to determine if the investigators can predict in advance which people can be helped.~   "
113097|NCT02087098|"~     This is a 12 month non-interventional study with solifenacin succinate, evaluating the effect~     of solifenacin on quality of life (QoL) of patients previously treated with antimuscarinics~     (Males and Females with Overactive Bladder (OAB) symptoms withdrawing their treatment with~     antimuscarinics because of safety and/or efficacy reasons) - measured by Perception of~     Treatment Satisfaction (TS-VAS) and to evaluate the effect of solifenacin on quality of life~     measured by Over Active Bladder-q Short Form (OAB-q SF), EuroQol Group scoring system~     (EQ-5D-5L).~   "
113098|NCT02087085|"~     This study will assess the safety and efficacy of the brimonidine intravitreal implant in~     patients with geographic atrophy due to age-related macular degeneration.~   "
113099|NCT02087072|"~     The primary objective is to develop a sustainable practice model emphasizing home visits by a~     collaborative physician and pharmacist team to decrease unplanned emergency department visits~     and hospital readmissions at 30 and 90 days for high-risk home bound patients. Secondary~     objectives include (1) tracking the number, type, and severity of adverse drug events (ADE)~     and potential adverse drug events (pADE) that occur following hospital discharge and (2)~     resolving any identified ADE and pADE within 7 days of hospital discharge.~      Adult patients will be scheduled for a home visit by the Healthy at Home Columbus program at~     the time of hospital discharge. The home visit will occur within 7 days of hospital discharge~     and will consist of a complete hospital and medication review by a physician or nurse~     practitioner and a pharmacist (including all lab tests, imaging studies, medication changes,~     and proposed plan of care at the time of discharge). The investigators hypothesize these home~     visits will reduce 30 and 90 days hospital readmission rates and ED visits.~      The number of emergency department visits and unplanned hospital readmissions will be tracked~     at 30 and 90 days following discharge from the hospitalization that led to study enrollment.~     A comparison cohort of patients discharged in the 12 months prior to study initiation will be~     used to compare the effectiveness of the home visit program. The number and type of adverse~     drug events (ADE) and potential adverse drug events (pADE) that occur during transitions of~     care will also be characterized. All ADE and pADE will be resolved during the initial home~     visit and will be classified based on severity. All ADE and pADE will be evaluated~     independently by two pharmacist reviewers; each reviewer will independently assign a severity~     rating to each ADE and pADE.~   "
113100|NCT02087059|"~     This is an open-label, multicenter clinical study in order to collect and examine data~     concerning the safety and efficacy of ruxolitinib in patients with Primary Myelofibrosis~     (MF), Post-Polycythemia Vera (PV) MF, Post-Essential Thrombocythemia (ET) MF.~   "
113101|NCT02087046|"~     The purpose of the proposed study is to demonstrate the safety and efficacy of the Totally~     Implantable Deep Brain Stimulation System in the ventral intermediate (VIM) nucleus of the~     thalamus implanted for the treatment of tremor due to essential tremor. This study will be~     included in the Pre-Market Approval Application to support the safety of this device in use.~   "
113104|NCT02087007|"~     This study will be conducted in accordance with the local regulation of New Drug Application.~     Overall duration of this trial will be 3 years after approval of KFDA.~      Each subject will participate around 7 weeks, which include the 2 weeks Amlodipine run-in~     period, 4 weeks double blind period and 1 week safety follow up period~   "
113105|NCT02086994|"~     We aim to compare carbetocin with misoprostol for the prevention of postpartum hemorrhage in~     patients with severe preeclampsia. The primary outcome is postpartum haemorrhage (blood loss~     of ≥ 500 ml) while our Secondary outcomes include use of additional uterotonics, need for~     blood transfusion, maternal adverse drug reaction, maternal complications and maternal death~   "
113106|NCT02086981|"~     Primary objectives are to define incidence and prevalence of Delirium in an elderly~     population admitted to the Department of Orthopedics and Traumatology and, in the~     postoperative phase, in the high Dependency Unit as well as to determine the presence of risk~     factors. Secondary objectives are to determine mean hospital stay, rates of complications as~     well as in-hospital mortality and at 1-3 and 12 months after discharge, functional recovery~     and cognitive outcomes at 1, 3 and 12 moths follow-up.~   "
113107|NCT02086968|"~     The primary objective of this study is to evaluate the treatment response of Injectafer vs.~     oral iron to baseline hepcidin levels to determine if any of these select IBD or Gastric~     Bypass patients may demonstrate to be inappropriate for oral iron therapy.~   "
113108|NCT02086955|"~     The purpose of the study is to evaluate the effectiveness of a nurse led intervention for~     high risk patients with diabetic foot ulceration and/or amputation.~      The effectiveness is defined in two ways 1) as a reduction in complication rates (time till~     ulceration recurrence, new ulcerations, amputation or reamputation) and 2) as a reduction in~     hospital readmissions for foot-related complication (one year survival probability: failure =~     readmission for ulceration recurrence, new ulcerations, amputation or re-amputation).~   "
113109|NCT02086942|"~     This phase 2 study will be conducted at 10 centers and enroll patients from August 2013 to~     August 2017.Firstly, All patients included will provide written informed consent. Secondly,~     they will be randomized equally to receive modified VCD regimen arm 1 or modified VCD regimen~     arm 2. In total, 47 patients per arm (or 94 in total) are required. The treatment consists of~     four 4-week cycles of induction therapy followed by intensive therapy with another five~     modified VCD regimens and maintenance treatment with CP regimen. Then, patients will be~     followed up for 24 months after chemotherapy. The investigators will record all the~     laboratory and clinical investigations to assess response at different points of the study.~     We also monitor and assess adverse events (AEs), as graded according to NCI-CTCAE Version~     3.0.Response categories were based on the International Myeloma Working Group uniform~     response criteria.In addition, 20 patients (10 in VCD regimen arm 1 group, 10 in VCD regimen~     arm 2 group) from ten centres will be enrolled in the pharmacodynamic substudy.~   "
113110|NCT02086929|"~     The study objective is to evaluate the efficacy and safety of trazodone OAD vs venlafaxine~     extended release (venlafaxine XR) after an 8-week treatment period in patients with major~     depressive disorder.~   "
113111|NCT02086916|"~     Acquiring diarrhoea in hospital is a serious problem and most frequently occurs when~     susceptible patients receive antibiotics as part of their (often life-saving) care. The~     commonest cause is Clostridium difficile - a bacterium that normally lives in up to a third~     of us but causes no problems. Rates of infection had been falling with increased awareness~     and improved hygiene but they are starting to creep up again. Clostridium difficile can cause~     a range of disease from a short-lived mild diarrhoea to severe disease of the bowel with~     major effects on the whole body and even death.~      This study aims to identify substances in the stool and in the blood to enable doctors to~     predict how severe that individual's disease will be. These tests can easily be performed. If~     they prove accurate in identifying the subsequent severity of the patient's illness due to~     Clostridium difficile, patients predicted to develop the worst disease can receive the most~     intensive treatments before they become too unwell to benefit. On the other hand, patients~     whose disease is predicted by these markers to run its course without causing serious~     consequences can be spared the side effects and risks of more intensive treatment.~   "
113112|NCT02086903|"~     To evaluate the pharmacodynamics of a lower Ticagrelor dose in healthy Korean volunteers~     compared with standard Clopidogrel agent.~   "
113113|NCT02086890|"~     Retinitis pigmentosa (RP) is a slowly progressive retinal degeneration for which there is no~     proven treatment. Patients are interested in trying alternative therapies to try to reduce~     their vision loss, but only limited research evidence exists to support their use and~     potential benefit. The goal of this research project is to gain a better understanding of~     possible changes in ocular and retinal blood flow and measures of vision in RP patients~     receiving two promising therapies, electroacupuncture and transcorneal electrical~     stimulation.~   "
113114|NCT02086877|"~     As survival rates from critical illness improve, strategies to return patients to their~     baseline cognitive and functional status are important research priorities. Up to 100% of ICU~     survivors will suffer some degree of cognitive impairment at hospital discharge and~     approximately 50% will have decrements that persist for years. While the mechanisms for this~     newly acquired brain injury are poorly understood, several risk factors have been identified.~     Unfortunately, it is unclear how to accurately predict long-term cognitive impairment.~      Immediate opportunities to improve cognitive outcomes through risk reduction exist. The~     investigators propose to comprehensively study the prevalence of sleep abnormalities and~     their association with cognitive impairment, as it may yield potential targets for effective~     therapy. Moreover, the investigators will examine for gene x environment associations [APOE~     ε4] that may allow for genetic risk stratification of individuals at greatest risk of~     cognitive impairment. The investigators hypothesize that EEG [a sensitive longitudinal marker~     of brain dysfunction] is a novel and independent predictor of long-term cognitive impairment,~     and possibly a candidate intermediate end point for future clinical trials.~      This study has the potential to identify novel biomarkers and risk factors for post-critical~     illness cognitive impairment, and may lay the foundation for rational interventions to~     mitigate risk in high-risk individuals.~   "
113115|NCT02086864|"~     Attention Deficit Hyperactivity Disorder (ADHD) is a developmental disorder that presents~     during childhood, with at least some symptoms causing impairment before the age of seven. It~     is characterized by developmentally inappropriate levels of inattention and/or~     hyperactive-impulsive behavior, with significant impairment occurring in at least two~     settings. It affects approximately 5.2 million children in the United States. Homeopathic~     treatment has been shown to be a promising intervention for ADHD, however the reasons for~     that effectiveness is unclear. Specifically, it is unclear whether improvement is due to the~     homeopathic medicine, the consultative process, or other non-specific effects.~      This study has 3 primary objectives: 1. to determine if there are any specific effects of~     homeopathic medicines in the treatment of ADHD, 2. to determine if there any specific effects~     the homeopathic consultation alone in the treatment of ADHD, and 3. to determine if there is~     an overall effect of homeopathic treatment (homeopathic medicines plus consultation) in the~     treatment of ADHD.~      This is a three arm study. Participants will be randomized to one of three arms:~      Arm 1 (Verum group): a treatment arm where the participant will receive homeopathic~     consultation plus a homeopathic remedy Arm 2 (Placebo group): a treatment arm where the~     participant will receive homeopathic consultation plus a placebo remedy Arm 3 (Usual care~     group): participants will continue with usual care and will not receive homeopathic treatment~     as part of the study.~      Participants enrolled in this study, regardless of which study Arm they are in, may continue~     with all conventional medications or any other aspect of their current standard of care they~     are taking as recommended by their usual physician (so long as they are on a stable dose of~     the conventional ADHD medication for at least 6 weeks prior to beginning the trial). They may~     also continue to attend regularly scheduled visits with their own health care~     practitioner(s).~      Participants may also start, stop or change the dose of any therapy (including conventional~     medications) during the study and are asked to report the change to the study team. Thus, the~     placebo group participants are not different than other participants, except that they will~     have a homeopathic consultation and a placebo remedy. The use of placebo is specific to~     homeopathic treatment, to allow for double-blinding, which is recognized to reduce study~     bias.~      Prior to enrolling in the study, those considering participation will undergo a full~     assessment by a psychiatrist with a specialty in child and youth mental health. This~     assessment confirms the diagnosis and screens for inclusion/exclusion study criteria. At the~     same time, the psychiatrist recommends evidence-based therapies to clients including~     conventional medication. The psychiatrist does not directly treat the client. If medication~     is recommended and the clients wish to pursue it with their regular physician, they would~     still be able to enroll in the study if they wanted to, after six weeks of reaching a stable~     dose.~      This study will help our understanding of the treatment process and whether different~     elements of the intervention have greater or lesser effects.~      This study is a follow-up to an open label pilot study of the homeopathic treatment of ADHD~     using the same study team. Sample size was calculated based on the results of that study.~   "
113141|NCT02086513|"~     This is a phase I trial of LDE225 for the treatment of steroid-refractory chronic Graft~     Versus Host Disease (GVHD).~   "
113116|NCT02086851|"~     The study will enroll 110 overweight and obese adolescents ages 11-16 in a lifestyle~     modification program focusing on dietary modification and exercise. Parents will be~     randomized into control and motivational interviewing-based intervention groups. The primary~     hypothesis is that adolescents whose parents are in the intervention group will have improved~     compliance, weight loss and health outcomes compared with adolescents whose parents do not~     receive the intervention.~   "
113117|NCT02086838|"~     Evaluate the effect of iron supplementation using oral routes in comparison with total dose~     infusion of low molecular weight iron dextran in iron deficiency anemia during pregnancy.~   "
113118|NCT02086825|"~     The aim of the current study is to determine whether rifaximin or lactulose is more effective~     in preventing the development of severe hepatic encephalopathy in hospitalized patients with~     cirrhosis and new onset kidney failure.~      Subjects will be randomly assigned to one of two treatment groups:~      Group A: Lactulose 20g dose titrated to 2-3 soft-formed bowel movements per day Group B:~     Rifaximin 550mg tablet twice daily.~      Subjects will be followed daily for two weeks or until hospital discharge. Treatment success~     is defined as prevention of grade 3 or 4 HE during hospitalization.~   "
113119|NCT02086799|"~     This study will explore whether supplementation with thyroid hormones in the set-up of asthma~     exacerbation could improve the clinical outcomes.~      The study will include adults admitted to Rambam health care campus for moderate to severe~     Asthma exacerbation.~      The study is a prospective, randomized, double-blind, placebo-controlled, clinical trial.~     Patients will be randomized on admission to receive treatment with intra-venous thyroxine~     (100mcg once on admission and additional 100mcg after 12 hours) or placebo. The study~     treatment will be given only after the initial bronchodilator therapy, oxygen and informed~     consent are given. The primary endpoint is the time to return of the peak expiratory flow~     (PEF) rate to normal values or personal base line.~   "
113120|NCT02086786|"~     To characterize the pharmacokinetics (PK) of the injectable intramuscular (IM) long-acting~     formulation (in situ microparticle, ISM) of risperidone over four IM injections in the~     gluteal and deltoid muscle at 28-day intervals and at one dose strength (75 mg) in patients~     with schizophrenia.~   "
113121|NCT02086773|"~     The purpose of this study to determine if a lower hemoglobin transfusion threshold, 7 g/dL,~     has a safety profile similar to that of the current standard transfusion threshold of 8 g/dL.~   "
113122|NCT02086760|"~     Diagnosis and follow up of hydronephrosis is actually based on repeat ultrasonography and~     scintigraphy wich is a binding exam for children. We wanted to evaluate the use of~     ultrasonography sensibilized by an oral hydration and to determine its efficiency to detect~     which hydronephrosis need a surgery or not.~   "
113123|NCT02086747|"~     The investigators hypothesized that 1 mg of acetaminophen 4 times per day for 3 days prevent~     chronic pain in hysterectomy patients.~   "
113124|NCT02086734|"~     The purpose of this study is the evaluation of dynamic contrast-enhanced CT (Perfusion-CT)~     for therapeutic response predicition in patients with metastasized renal carcinoma (mRCC)~     undergoing antiangiogenetic therapy (AAT) with multikinase inhibitors.~      In this study patients with mRCC under AAT will be examined with 3 serial Perfusion - CT~     scans - partially intergrated in their regular staging CT scheme - at baseline (before AAT~     start), 1 week after AAT as well as 8 weeks after AAT initialization. Thereby selected~     intrabdomial or intrathoracic metastases will be monitored longitudinally with perfusion CT.~     Pretreament and post-treament perfusion characteristics of the assessed metastatic lesions~     will be quantified and correlated with patient outcome.~   "
113125|NCT02086721|"~     The formation of metastasis is responsible for as much as 90% of cancer-associated mortality.~     In spite of recent advances in oncologic therapy, approximately 50 % of the lung cancer~     patients have already overt disseminated cancer at diagnosis. Additionally, numerous patients~     with locoregional disease initially treated with curative intent develop (oligo)metastases~     during the course of disease. In both instances, these stage IV patients are generally~     considered to be incurable and mostly treated palliatively.~      Oligometastases, defined as 1-5 sites of active disease on whole body imaging, was coined to~     refer to isolated sites of metastasis resembling limited tumor metastatic capacity. The~     implication of this concept is that local cancer treatments are curative in a proportion of~     patients with metastases and that incorporating local therapy is a conceptually attractive~     approach. In several, but not all, academic centers the standard treatment of patients with~     oligometastases in good general health is standard chemotherapy followed by surgery or by~     Stereotactic Ablative Body Radiotherapy (SABR) with radical dose on the macroscopic visible~     tumors.~      The widespread introduction of SABR and of minimally invasive surgery has fuelled research in~     treating patients with oligometastases. Indeed, local control of metastases can be obtained~     in virtually all parts of the body with a low proportion of patients experiencing severe side~     effects. In the few prospective studies published to date, approximately 20% of patients~     remained free of recurrence several years after treatment when all sites of disease were~     targeted by radiation.~      Along with standard anti-cancer therapeutic modalities like chemotherapy and radiotherapy~     (RT), immunotherapy has recently gained a lot of attention.~      Angiogenesis is one of the hallmarks of cancer, and therefore, considerable efforts have been~     made to exploit this unique target for selective drug delivery. One of the appealing targets~     for both approaches is the splice variant of fibronectin containing extra domain B (EDB),~     which is abundantly expressed in vascular endothelial cells of a variety of primary tumors as~     well as metastases , but virtually absent in normal tissues. Recently, a human recombinant~     scFv fragment directed against EDB, designated L19, was developed and subsequently combined~     with the pro-inflammatory interleukin-2 (IL2), resulting in the immunocytokine L19-IL2.~     L19-IL2 delivers high doses of IL2 to the (metastatic) tumor site(s) exploiting the selective~     expression of EDB on newly formed blood vessels. Interleukin-2 (IL2) plays an essential role~     in the activation phases of both specific and natural immune responses. Even though it has no~     direct cytotoxic effects on cancer cells, it can induce tumor regression by stimulating a~     potent cell-mediated response. In summary, L19-IL2 is an immunocytokine which will stimulate~     immune response specifically in tumors with angiogenesis and tissue remodeling.~      Radiotherapy is a particularly interesting partner for immunotherapy, since it can be~     harnessed to specifically modify the immunogenicity of the primary tumors and their~     microenvironment, in the attempt to generate an in situ immunization of the host against a~     patient's own cancer. Our hypothesis is that three independent therapeutic approaches will~     synergize to improve dramatically survival in patients with oligometastases of solid tumors.~   "
113126|NCT02086708|"~     HYPOTHESIS: The investigators hypothesize that sonoelastography (SE) provide accurate~     quantitative measurements that can be used to stage liver fibrosis in pediatric patients with~     chronic liver disease.~      Specific Aims:~      To measure liver stiffness with sonoelastography in pediatric and adolescents with suspect~     diffuse liver disease who will undergo nonfocal liver biopsy as part of their routine~     clinical care.~   "
113127|NCT02086695|"~     The early detection of BVZ or Sunitinib mediated cardiotoxicity using cardiac biomarkers and~     novel Transthoracic Echocardiogram (TTE) techniques may allow one to adjust treatment and/or~     administer prophylactic cardioprotective agents, prior to the development of irreversible~     cardiac dysfunction. We hypothesize that cardiac biomarkers, TVI/strain-derived indices will~     be able to accurately detect subtle cardiac injury at a time when conventional Left~     Ventricular Ejection Fraction (LVEF) remains normal in BVZ or Sunitinib mediated~     cardiotoxicity. Additionally, we hypothesize that Endothelial Function Test (EndoPAT) testing~     can detect early BVZ or Sunitinib mediated endothelial dysfunction.~   "
113128|NCT02086682|"~     The introduction of unfractionated heparin (UFH), which prevents clotting of the~     extracorporal circuit, was one of the key advances that led to the rapid development and~     expansion of hemodialysis services. However, anticoagulation during hemodialysis of the~     patient at high risk for bleeding remains a frequently encountered problem in both inpatient~     and outpatient dialysis practice.~      Streamline bloodlines are designed to eliminate blood-air contact. This is thought to help~     reduce heparin use and decrease clotting rates. The goal of this study is to prospectively~     examine impact of the Streamline airless blood tubing set, in an inpatient setting, on~     dialysis circuit clotting rates, anticoagulation use, and dialysis efficiency.~   "
113129|NCT02086669|"~     Patients with newly diagnosed achalasia have been submitted to either treatment with~     pneumatic dilatation or surgical myotomy. Minimal follow up five years.~   "
113130|NCT02086656|"~     Capecitabine, oxaliplatin, irinotecan and bevacizumab as perioperative strategy of borderline~     and/or high risk resectable colorectal cancer liver metastases~   "
113131|NCT02086643|"~     The goal of this study is to determine the success rate of the retroclavicular approach for~     the anesthesia of the upper limb in the obese patient population (BMI ≥ 30 kg/m2)~   "
113142|NCT02086500|"~     The purpose of this study is to determine if 1 gram of prehospital tranexamic acid given~     during air medical transport to a level 1 trauma center in patients at risk of hemorrhage is~     associated with lower 30 day mortality.~   "
113143|NCT02086487|"~     whether Nilotinib at the two sequential dosage forms will induce quicker and deeper response~     in those patients, and if FISH on PB (Peripheral blood) would be an effective way to monitor~     response compared to conventional cytogenetics on bone marrow (BM) sample~   "
113132|NCT02086630|"~     This study addresses racial/ethnic disparities in HIV/AIDS treatment. Many persons living~     with HIV/AIDS (PLHA) in the U.S. (10-19% of PLHA), predominantly African-Americans and~     Latinos, delay taking Highly Active Antiretroviral Therapy (HAART) until late in the course~     of their HIV disease or never initiate HAART when it is medically indicated. However, there~     are no behavioral interventions to increase HAART initiation among PLHA who delay or decline~     HAART (PLHA-DD). The overarching aim of the proposed study is to develop a flexible,~     targeted, and sustainable behavioral intervention to increase HAART initiation among PLHA-DD,~     which, if efficacious, will lead to reductions in morbidity, early mortality, and health care~     costs, as well as increased viral load suppression (reducing transmission to others).~     Further, the study complements and primes participants for existing adherence interventions,~     from which PLHA-DD can benefit when they initiate HAART.~   "
113133|NCT02086617|"~     The purpose of this study is to investigate prevalence of abdominal aortic aneurysms (AAA)~     among male patients with coronary artery disease (CAD). Secondary purpose is to document~     cost-effectiveness of ultrasound screening of AAA in selected population.~      Ethiology of AAA is known to be common with atherosclerotic arterial diseases, and on the~     basis of our previous studies (ClinicalTrials.gov ID CAD-AAA-02) the prevalence of AAA seems~     to be higher in CAD population than unselected male population. This leads to hypothesis that~     selective screening of these patients (for AAA) could be cost-efficient and life saving~     option for detecting AAAs before rupture.~      Study will be carried out as a single-center prospective screening study. Patients will be~     selected for this study on basis of their ICD 10 diagnose codes in North Carelian patient~     information system. Inclusion criteria will be any kind of atherosclerotic heart disease~     (ICD10 codes I20-I25). Criteria for exclusion are malignant disease, already diagnosed or~     treated AAA and failure to give informed consent.~      800 patient records that meet the inclusion criteria will be reviewed for eligibility.~     Invitations for screening will be sent for 600 patients with intention to have at least 400~     patients screened. Screening will be done by verified sonographers in designated screening~     appointments.~   "
113134|NCT02086604|"~     This Phase I clinical trial studies the side effects and maximum tolerated dose (MTD) of the~     combination of brentuximab vedotin (BV) and lenalidomide in the treatment of patients with~     relapsed or refractory diffuse large B-cell lymphoma (DLBCL).~   "
113135|NCT02086591|"~     The purpose of this study is to determine whether doxycycline is effective in the treatment~     of relapsed Non Hodgkin Lymphomas (NHL).~   "
113136|NCT02086578|"~     The purpose of this study is to determine if a radiation treatment called Multi-beam~     Intensity Modulated Radiation Therapy(IMRT) can reduce side effects related to your implant~     if they are a candidate for radiation therapy. Currently, the standard method of giving~     radiation is with 3D radiation, which only uses 2-5 beams of radiation. Multi-beam IMRT~     works by using 8-12 small radiation beams to give a more tailored or customized radiation~     dose to the implant, breast, chest wall and lymph nodes. At the same time, multi-beam IMRT~     may lower the radiation dose to the heart, lung and nearby tissues. The goal of the study is~     to reduce complications after irradiation to the implants.~      The study doctors have recently completed a trial using this technique and are now~     specifically looking at its impact on women with implant reconstructions who are undergoing~     post-mastectomy radiation therapy. By delivering a more customized dose of radiation to the~     implant, the intent is to reduce side effects of radiation on the implant.~   "
113137|NCT02086565|"~     Background: Asthma morbidity is high in inner-city minority adults, despite the existence of~     efficacious therapy. Tailored, patient-centered interventions are needed to improve access to~     care and patient-provider communication. Access and communication increasingly rely on~     information technology (IT) as new incentives arise to use the Electronic Health Record~     (EHR). The EHR patient portal (PP) gives patients web-based communication with providers and~     practices. How the poor and those with limited educational opportunities can take advantage~     of these is unclear. In contrast, the investigators have found that home visits (HVs) by~     community health workers (CHWs) can improve access to care for children and promote~     caretaker-clinician communication. The investigators also found many inner-city adults have~     internet access and are willing to learn to use the PP.~      Objective: to examine the benefits for adults of using the PP with and without HVs by CHWs~     who will encourage/facilitate PP use, understand patients' social context, and enhance~     communication with the medical team. The investigator hypothesize all patients will benefit~     from PPs, and that the addition of HVs will be particularly helpful for those with low~     literacy or language barriers. Specific Aims test if the 1-year interventions result in 1)~     better within-group asthma outcomes, 2) better outcomes in one group over the other, 3) more~     communication (use of PP) and access (appointments made and kept) which mediate the~     interventions' effects on asthma outcomes, and 4) effect modification by literacy level,~     primary language, and convenience of internet access.~      Methods: In a randomized controlled trial, 300 adults, predominantly African American and~     Hispanic/Latino, with uncontrolled asthma recruited from low income urban neighborhoods will~     be assured internet access and taught to use the PP, with and without HVs from a CHW. CHWs~     will 1) train patients to competency in PP use, 2) enhance care coordination, 3) transmit a~     view of the complex social circumstances of patients' lives to providers, and 4) make up for~     differences in patients' health literacy skills.~      Patient Outcomes are asthma control, asthma-related quality of life, emergency department~     (ED) visits, and hospitalizations for asthma or any cause. Together asthma and other health~     conditions affect patients' ability to perform their daily tasks and care for their families.~     Potential benefits of the intervention are enhanced patient-clinician communication, access~     to care, improved health, and ability to use IT.~   "
113138|NCT02086552|"~     This phase II trial studies how well sonidegib and lenalidomide after stem cell transplant~     works in treating patients with multiple myeloma. Sonidegib and lenalidomide may stop the~     growth of cancer cells by blocking some of the enzymes needed for cell growth and may delay~     multiple myeloma from coming back after a stem cell transplant.~   "
113139|NCT02086539|"~     This study aims to determine the effectiveness of 4 different recruitment techniques for~     enrollment into a cholesterol study. 2,000 people that meet initial eligibility criteria for~     the study will be randomized into one of 4 groups and will all receive the same recruitment~     letter inviting them to participate in the study by enrolling on an online platform. Group 1~     will receive the recruitment letter in a normal sized envelope, Group 2 will receive the~     recruitment letter in an 8.5 x 11 inch envelope, Group 3 will receive a recruitment letter~     shipped via USPS priority mail and a Group 4 will receive a recruitment letter with the image~     of an Amazon gift card and told they will receive a $25 gift card if they enroll in the~     study. All other groups are told that they will receive a $25 check upon enrollment in the~     study.~   "
113140|NCT02086526|"~     The investigator's global hypothesis is that women with Polycystic Ovary Syndrome (PCOS) can~     be separated into subtypes based on their response to metformin. The investigators propose~     here to use both targeted and non-targeted metabolomic approach to identify pathways~     associated with metformin's effect on insulin sensitivity and endothelial function. This~     pilot project will be the foundation for developing tailored therapeutic approaches to~     Polycystic Ovary Syndrome and identifying novel drug targets.~   "
113144|NCT02086474|"~     The objective of this study is to assess the changes in daily physical activity and gait~     pattern, following a viscosupplement injection among a population who is suffering from hip~     osteoarthritis. A kinetic and kinematic gait analysis, an Actigraph activity monitor, a~     functional Timed-Stair-Test and two questionnaires (Medical Outcome Study Short-Form36~     (MOS-SF36), Hip disability and Osteoarthritis Outcome Score (HOOS)) about how the pathology~     affects the quality of life, will be use.~   "
113145|NCT02086461|"~     Delayed emptying of the gastric tube after esophagectomy is a frequent and durable problem.~     No treatment is currently available. It can be hypothesized that incomplete relaxation of the~     pyloric sphincter may be a significant contributing factor. Pneumatic dilatation may~     therefore be a potentially effective treatment.~   "
113146|NCT02086448|"~     The purpose of this study is to better understand how sleep apnea, a common sleep disorder in~     which a person has one or more pauses in breathing or shallow breaths while sleeping, may~     affect pregnancy and to determine the effect of Continuous Positive Airway Pressure (CPAP), a~     treatment that uses mild air pressure to keep the airways open during sleep, for pregnant~     women with sleep apnea.~   "
113147|NCT02086435|"~     The aim of this study protocol will be to compare the technique of intracorporeal~     morcellation using reusable electronic device (standard technique) with a technique of~     removal protected by endobag and extracorporeal myoma morcellation with cold scissors and~     scalpel blade or with power morcellator used inside the bag itself.~   "
113148|NCT02086422|"~     Patients with CHF benefit from heart rate lowering, and the investigators have previously~     demonstrated that this does not adversely affect exercise tolerance. In a pacemaker~     population we also have shown that preventing heart rate lowering is detrimental in terms of~     symptoms and prognosis.~      The aim of the study is to therefore to establish whether heart rate limitation in patients~     with heart failure has a negative impact on exercise capacity. If the investigators establish~     that this is not the case, physicians will be able to confidently prescribe heart rate~     lowering agents, and programme pacemakers to allow bradycardia without the concern that there~     will be detrimental effects of symptom.~   "
113149|NCT02086409|"~     Gait and posture disorders are very common in subjects aged 65 and over, and result mainly~     from neuromuscular and cognitive disorders.~      Many studies have shown that 1) vitamin D deficiency is very common in women aged 65 and~     over, 2) individuals with hypovitaminosis D have lower muscle, gait and executive~     performances and are more prone to fail than individuals with no hypovitaminosis D, 3) the~     intake of vitamin D combined or not with calcium may improve muscle strength and cognitive~     performance.~      The investigators hypothesized that the daily intake of 2 yogurts containing 200 IU of~     vitamin D and 400 mg of calcium 1) can improve spatiotemporal gait parameters, posture and~     executive performance, 2) and that this improvement depends of the initial level of vitamin D~     deficiency.~   "
113150|NCT02086396|"~     This study aimed to evaluate the effect of weight loss diet combined with pumpkin seed flour~     consumption on diet improvement, weight loss, and glucose and cholesterol reduction in obese.~   "
113151|NCT02086383|"~     The purpose of this study is to investigate whether pulmonary rehabilitation (PR) is~     effective in increasing level of (a) physical activity (PA) and (b) self-efficacy in patients~     with chronic obstructive pulmonary disease (COPD).~      PR is an evidence-based multidisciplinary approach consisting primarily of a supervised~     exercise program with educational components. It has demonstrated high efficacy in improving~     dyspnoea, health-related quality of life (HRQoL) and functional exercise capacity in patients~     with COPD. Despite these improvements, there is no conclusive evidence that these benefits~     translate to an increase in PA in patient's day-to-day life. This is of concern as low PA is~     a predictor of all cause mortality, correlated with lower HRQoL, increased level of dyspnoea~     and higher number of hospital admissions in this group of patients.~      Self-efficacy is found to be an instigating force in forming intention to exercise and in~     maintaining practice for an extended time. Self-efficacy may be the key in determining~     whether a patient translates the improvement in exercise tolerance to actually being more~     physically active. Based on current knowledge, there is insufficient evidence that~     self-efficacy increases after pulmonary rehabilitation and no correlation has been made~     between level of self-efficacy and level of PA in these group of patients.~      Hence this study aims to find out whether the existing PR program increases level of PA and~     self-efficacy. Correlation between level of PA and self-efficacy will be made.~   "
113152|NCT02086370|"~     The aim of this RCT of study is to compare the outcomes of the standard salpingectomy~     (removal of the fallopian tube) with the radical removal of the tube and the mesosalpinx in~     terms of ovarian reserve.~   "
113153|NCT02086357|"~     Ultrasound (US)tissue elastography has recently been found to have a number of clinical~     applications in the assessment of soft tissue disease for example, in breast and thyroid~     pathology. There are few current studies exploring its use in musculoskeletal pathology,~     particularly a new technique called sheer wave ultrasound elastography (SWUE).~      Magnetic Resonance (MR) elastography has shown wide reaching applications in orthopaedics,~     sports medicine and rheumatology and SWUE may have the potential to also demonstrate clinical~     effectiveness in these areas.~      Our aim is to explore the effectiveness of this technique in the assessment of~     musculoskeletal pathology.~      Participants will be recruited through current referral protocols and would undergo an~     additional elastographic investigation in addition to their standard US examination. This~     investigation will be conducted within the musculoskeletal US department at Chapel Allerton~     Hospital by trained musculoskeletal specialists. The study will be conducted over a period of~     approximately 24 months with quarterly review during this time.~   "
113154|NCT02086344|"~     The aim of this RCT of study is to compare the standard TLH with adnexal preservation with~     TLH plus prophylactic bilateral salpingectomy (PBS) in terms of ovarian reserve and surgical~     outcomes~   "
113155|NCT02086331|"~     This study aims to validate the use of Dynamic Contrast-Enhanced Ultrasound in measuring the~     blood supply to the muscles of the leg, and how this changes with exercise and vascular~     pathology.~   "
113156|NCT02086318|"~     To collect data of clinical, biochemical and 3D-ultrasonographic parameters of a population~     of fertile women aged 18-55 in order to design a new algorithm able to predict ovarian age~     and to evaluate the reliability of a multimodal diagnostic evaluation of ovarian age in term~     of both reproductive prognosis and distance to menopause following the guidelines of the~     Standards for Reporting of Diagnostic Accuracy initiative (STARD)~   "
113157|NCT02086305|"~     Palliative care for end-stage organ failure patients has been included as one of the key~     programs to be implemented in 2011-2012 in the Hospital Authority, Hong Kong. Among all the~     disease groups, end-stage heart failure patients have the highest mortality rate. Patients at~     the end stage of heart failure have health concerns shared by other end-stage patients~     including cancer patients. Many guidelines, local and world-wide, have advocated a palliative~     approach of care for those heart failure patients who are at end stage. Studies have shown~     that end-stage heart failure patients tend to have frequent emergency room visits and~     repeated hospital admissions. Also, these patients suffer from a number of health problems~     that adversely affect their Quality Of Life.~      There is scarcity of experimental studies informing practitioners which models work best for~     palliative patients in Hong Kong. There were randomized controlled trials conducted outside~     Hong Kong which suggest multidisciplinary approach of palliative care is possible to reduce~     readmissions but evidence is not present for other outcomes such as symptom control and carer~     burden.~      In an attempt to fill knowledge gap and inform practice using evidence, this study is~     launched to compare the effects of a customary hospital-based palliative heart failure care~     and an interventional Home-based Palliative heart failure Program.~      Hypothesis~        -  there is no difference in health care utilization for end-stage heart failure patients~          between the customary hospital-based group and the Home based palliative heart failure~          program group~        -  there is no difference in evaluated health outcomes (functional status, symptom~          intensity, and satisfaction with care) between the customary hospital-based group and~          the Home based palliative heart failure program group~        -  there is no difference in perceived health outcomes (quality of life, caregiver burden)~          between the customary hospital-based group and the Home based palliative heart failure~          program group~        -  there is no difference in cost effectiveness between the customary hospital-based group~          and the Home based palliative heart failure program group~        -  there is no difference In patients' lived experiences between the customary~          hospital-based group and the Home based palliative heart failure program group~   "
113158|NCT02086292|"~     The aim of the study is to find a simple method for pain reduction that can be used in~     clinical practice when administering digital nerve block with a single subcutaneous~     injection. It will be investigated whether a smaller volume of lidocaine can decrease pain~     during injection.~   "
113159|NCT02086279|"~     To evaluate the variation of AMH levels in women undergoing treatment with GnRHa, and to~     assess whether this variation correlates with changes in the antral and pre-antral follicle~     ultrasonographic count (AFC).~   "
113160|NCT02086266|"~     The purpose of this study is to compare the efficacy between a Pilates exercise program and a~     Pelvic Floor Muscle Training (PFMT) protocol combined with anal electrical stimulation (AES)~     in the recovery of urinary continence (UI) after radical prostatectomy.~      There are no studies that evaluate Pilates mat exercises for incontinence in men although it~     can be assured that this method has the pelvic floor contractions as a principle for~     practice. If this new therapeutic approach proves to be as effective as described treatment~     in improving urinary complaints, it will be an option for patients who prefer a non-invasive~     treatment.~   "
113161|NCT02086253|"~     Endothelial dysfunction of conduit arteries contributes to the increased morbidity and~     cardiovascular mortality in patients with essential hypertension and appears increasingly as~     an independent therapeutic target. We have shown previously that besides a decrease in the~     availability of NO and other endothelium-derived vasodilators factors, the~     epoxyeicosatrienoic acids, an increase in the vasoconstrictor endothelin-1 (ET-1) may play a~     role in the pathophysiology of this endothelial dysfunction. Indeed, the local concentrations~     of endothelin-1 during the endothelium-dependent dilation of the radial artery in response to~     a sustained increase in blood flow decreased significantly in healthy volunteers controls but~     not in hypertensive patients. This lack of adaptation of the endothelinergic system could be~     due to a decreased clearance of endothelin-1 by endothelial ETB receptors, potentiating the~     vasoconstrictor action of endothelin-1 mediated by ETA receptor activation at the muscular~     level. However, to validate this hypothesis , it is needed to demonstrate the physiological~     role of ETA receptor and ETB in sustained flow-mediated dilatation of conduit arteries.~   "
113162|NCT02086240|"~     The Translocator Protein (TSPO) is a protein which reaches very high levels when there is~     inflammation in the brain.~      Recently, radioligands have been developed which attach to the TSPO (a radioligand is a drug~     which has been tagged with radioactivity). Using positron emission tomography (PET) imaging,~     the radioligand can be detected following injection into a patient. However, it is difficult~     to accurately measure the amount of TSPO using PET at the moment. This is because the brain~     does not have a reference region for TSPO (ie an area in the brain with no TSPO at all).~     Reference regions are very useful to help work out how much of a PET signal represents~     specific binding (of the radioligand to the target of interest), and how much represents~     non specific binding (of the radioligand to many other structures which are not of~     interest). In the absence of a reference region, non specific binding can be estimated by~     giving a drug which binds to the TSPO.~      The drug prevents the radioligand binding the TSPO and (in a manner of speaking) creates a~     temporary reference region so non specific binding can be measured. To do this, we will use~     XBD173 (Emapunil is an anxiolytic drug which acts as a selective agonist at the peripheral~     benzodiazepine receptor) to bind TSPO and block binding of the PET ligand ([11C]PBR28), a~     TSPO ligand from the phenoxyarlyacetamide class.~      Most TSPO PET studies (and in one of our previous studies approved by West London REC)~     quantify the signal using a ratio of specific binding in the brain to radioactivity in the~     blood. This requires arterial line insertion which is burdensome for subjects, and increases~     variability. In this study we aim to determine the ratio of specific binding in the brain to~     nonspecific binding in the brain by using the temporary reference region. For more accuracy~     the participants will repeat the scanning procedure so determine test-retest variability of~     the amount of TSPO.~   "
113163|NCT02086227|"~     The primary objective of this study is to ascertain the pharmacokinetics (PK) and~     pharmacodynamics (PD) bioequivalence of a subcutaneous (SC) injection of 1 mg (1 IU) of~     Glucagon (Fresenius Kabi USA) in comparison to the reference product, GlucaGen® (Bedford~     Laboratories), 1 mg (1 IU), SC in healthy adult subjects.~   "
113164|NCT02086214|"~     The purpose of this study is to assess the efficacy of a 6 months upper arm proprioceptive~     pressure therapy on Assisting Hand Assessment (AHA) performance in Cerebral Palsy (CP). To~     perform this study, 80 CP patients aged of 5 to 10 years old will be included in a~     multicentric, double blind, prospective parallel-group randomized study. Treatment will be a~     pressure therapy using a LYCRA® compressive sleeve initially used in burn therapy. Primary~     outcome is to increase of 60% of AHA performance. The secondary outcome are to increase~     Quality of Upper Extremity Skill Test (QUEST), quality of life and improve Somatosensory~     Evoked Potentials (SEP).~   "
113165|NCT02086201|"~     This is a non-inferiority trial of Engage, a new intervention for late-life depression, and~     problem solving therapy (PST). Patient participants will be randomized to either Engage or~     PST and receive 9 weeks of either intervention. Interview assessments will be collected at~     baseline and weeks 2, 4, 6, 8, 9, 26, and 36. Clinician participants, social workers from~     mental health agencies, will be randomized to receive training and certification in either~     Engage or PST.~   "
113166|NCT02086188|"~     The purpose of this study is to determine if treatment with Mirabegron will improve urinary~     urgency control beyond that achieved with pelvic floor exercises alone~   "
113167|NCT02086175|"~     This research study is evaluating a drug combination called Imprime PGG and Rituximab as a~     possible treatment for relapsed/refractory indolent B cell non-Hodgkin lymphomas (NHL).~   "
113205|NCT02085681|"~     The aim of this study is to compare the effectiveness of identifying diabetic retinopathy~     using tele-medicine based Digital Retinal Imaging in Diabetes Clinics with that of the~     conventional referral system.~      Hypothesis: Tele-medicine based digital retinal imaging involving a diabetes centre will~     identify proportionately more diabetic patients with DR and lead to higher acceptance rate~     with subsequent ophthalmic referral and management~   "
113168|NCT02086162|"~     Up to 80% of people with schizophrenia and schizoaffective disorders smoke - a rate that is~     four times the rate in the general population. Cessation treatments are effective, but these~     smokers don't use them. In order to provide an easy-to-use, cost-effective strategy to engage~     this group of smokers into effective treatments, we developed a single-session, web-based,~     motivational decision support system, Let's Talk About Smoking. The system incorporates~     features that insure high usability among those who can't use current websites due to~     cognitive impairments and low computer skills. It provides compelling content that engages~     users into evidence-based cessation treatments.~      In this study we will definitively test the decision support system in a randomized~     controlled trial (RCT) among smokers with severe mental illness (SMI) psychotic disorders.~     Our proposed study design will enable us to test whether this system, designed for those with~     cognitive impairments, is effective among people with a range of cognitive abilities. The~     Specific Aims of the study are:~        1. To determine whether use of the web-based decision support system leads to higher rates~          of initiation of smoking cessation treatment than use of a computerized educational~          pamphlet. We will also assess effectiveness on secondary outcomes, including smoking~          behavior, urges and outcome expectancies; level of dependence; intentions to quit and to~          use cessation treatment; and abstinence.~        2. To assess whether cognitive ability moderates initiation of smoking cessation treatment.~          Since cognitive impairment impedes use of standard web-based interventions by this~          group, and cognitive impairments likely supersede other potential moderators (education~          and socioeconomic status), this aim will be key to determining the success of our~          intervention and will guide further revisions if they are needed.~        3. To explore the effects of the decision support system and baseline cognitive ability on~          abstinence over 6 months~             1. We will examine the impact of the DSS on 7-day point prevalence tobacco abstinence~               at 6 months, and cumulative days of tobacco abstinence over 6 months.~             2. We will determine whether baseline cognition (scale scores) is associated with~               7-day point prevalence tobacco abstinence at 6 months, and cumulative days of~               tobacco abstinence over 6 months.~   "
113169|NCT02086149|"~     The purpose of this study is to test the effect of a moderate-intensity aerobic exercise~     intervention for helping individuals with elevated depressive symptoms to quit smoking. The~     investigators expect that this project will contribute much needed knowledge about the role~     that aerobic exercise can play in smoking cessation. The long-term goal of this program of~     research is to disseminate an effective, aerobic exercise (AE) intervention for smoking~     cessation that can be readily adopted by smokers with elevated depressive symptoms, including~     those with current major depressive disorder (MDD).~   "
113170|NCT02086136|"~     Acute aortic dissection (AD) is a deadly, difficult to diagnose disease presenting with an~     array of common and unspecific symptoms. Aortic dissection detection (ADD) risk score as a~     bedside clinical tool to estimate the risk of AD. D-dimer has been evaluated in several~     studies as a biomarker of AD, and has showed a pooled diagnostic sensitivity of 97%. However,~     considering the severe morbidity and mortality of AD, a negative D-dimer per se is considered~     insufficient to rule-out AD in unselected patients.~      The aim of the present study is to evaluate whether the diagnostic performance of D-dimer~     differs in patients at different clinical risk of AD, and in particular whether a negative~     D-dimer test may allow safe rule-out of AD in any patient subgroup without necessity to~     perform urgent aortic imaging.~      Consecutive adult patients with suspected AD presenting to ED will be enrolled before the~     establishment of a final diagnosis; a standardized clinical form comprehensive of~     presence/absence of 12 risk markers allowing ADD risk score fulfilled and d-dimer levels~     measured at presentation.~      The aortic imaging exam used to confirm or refuse of AD will be computed tomography~     angiography or transesophageal echocardiography and final diagnosis established after~     reviewing of all available data.~      The accuracy, failure rate and efficiency of a diagnostic strategy combining standardized~     clinical stratification via the ADD risk score with D-dimer testing will therefore be~     assessed.~   "
113171|NCT02086123|"~     Laparoscopic colorectal surgery (LCS) has gained wide acceptance in the treatment of various~     pathology from diverticular disease to colon cancer. In comparison to conventional open~     surgery LCS has the benefits of shorter hospital stay, reduced postoperative pain, lower~     wound-related complication rates, better cosmetic results and earlier return to normal~     activities.~      Despite the fact that laparoscopic colorectal surgery is done through smaller incisions,~     there is still a considerable amount of abdominal wall trauma with these procedures. This~     still can cause a significant amount of postoperative discomfort, which can add to patients'~     stress, decreased satisfaction, and prolong length of hospital stay. Postoperative pain can~     be difficult to control and has been mainly managed pharmacologically with the use of~     narcotics and non-narcotic medications delivered through different routes. The effectiveness~     of pain control depends on the medication, its dosage, frequency and route of administration.~     The latter is mainly achieved through the intravenous route in the immediate postoperative~     period in laparoscopic colorectal surgery patient, as patients are restricted from having~     anything by mouth until return of bowel function.~      Another route of delivery is the use of local anesthetics as well as opioids via an epidural~     catheter. Epidural analgesia (EA) has the potential to offer excellent pain control and~     decrease the rate of postoperative ileus. Despite the extensive use of epidural anesthesia in~     obstetrics, to date there has been very few studies looking at the effectiveness of epidural~     analgesia in laparoscopic colorectal surgery.~      The primary purpose of this study is to evaluate the impact of epidural analgesia as compared~     to conventional analgesia on the length of hospital stay in patients undergoing laparoscopic~     colorectal procedures. The secondary objectives of the study will be to evaluate patient~     satisfaction, quality of life, pain control and return of bowel function in patients treated~     with either epidural analgesia or intravenous narcotics.~   "
113172|NCT02086110|"~     The purpose of this study is to determine the tolerability of dietary supplements and if~     these supplements can promote a healthy bacterial environment in the intestines of children~     with autism spectrum disorders and gastrointestinal complaints.~   "
113173|NCT02086097|"~     The purpose of this study is to investigate the analgesic efficacy of multiple doses of~     Dexketoprofen Trometamol 25 mg on postoperative pain following emergency endodontic treatment~     in teeth with irreversible pulpitis, using as control Ibuprofen 600 mg and a placebo group.~      Hypothesis:~      Dexketoprofen trometamol when administered in multiple doses produces a greater effect to~     control postoperative pain after treating symptomatic irreversible pulpitis; in patients~     undergoing pulpotomy as an emergency procedure~   "
113174|NCT02086084|"~     Chronic obstructive pulmonary disease (COPD) is one of the UKs commonest chronic diseases and~     is responsible for a significant number of acute hospital admissions. COPD is characterised~     by progressive destruction in the elastic tissue within the lung, causing respiratory~     failure. The clinical course of COPD is characterised by recurrent acute exacerbations~     (AECOPD), causing considerable morbidity and mortality. Patients with moderate to severe~     acute exacerbations present with increased work of breathing and hypercapnia. The standard~     for respiratory support in this setting is non-invasive ventilation (NIV), a management~     strategy underpinned by a considerable evidence base. However despite NIV, up to 30% of~     patients with AECOPD will 'fail' and require intubation and mechanical ventilation. The~     mortality rate for patients requiring NIV is approximately 4%, if conversion to mechanical~     ventilation occurs the mortality is 29%.~      The last decade has seen an increasing interest in the provision of extracorporeal support~     for respiratory failure. The key element that has underpinned improving survival has been~     technological advancement. This has resulted in pumps causing less blood trauma and~     inflammatory response, better percutaneous cannulation techniques and coated circuits with~     reduced heparin requirements. Overall this has significantly reduced the complications~     associated with the provision of extracorporeal support. One variation of this technique~     (extra-corporeal CO2 removal ECCO2R) allows CO2 clearance from the blood. This approach has~     been the subject of a number of animal experiments and uncontrolled human case series~     demonstrating improved arterial CO2 and reduced work of breathing. Our own unpublished series~     demonstrates the same physiological changes. However to date the benefits of this approach~     have not been tested in a randomised controlled trial.~      The hypothesis is that the addition of ECCO2R to NIV will shorten the duration of NIV and~     reduce likelihood of intubation.~   "
113206|NCT02085668|"~     The purpose of the trial is to investigate the safety and effectiveness of renal denervation~     for the treatment of chronic heart failure (CHF).~   "
113175|NCT02086071|"~     Feasibility of new biological and histological samples at progression in patients with~     advanced or metastatic Non Small Cell Lung Cancer (NSCLC).~      A recent paper from Pr Sequist and coll. has depicted the resistance mechanisms as~     Thréonine790Methionine (T890M) mutation oncogene cMet (CMet) amplification. Re-biopsies~     showed in 14% of cases the transition between NSCLC to Small Cells Lung Cancer (SCLC). In 3~     patients, resistance mechanisms have disappeared and they became again sensitive to Tyrosine~     Kinase Inhibitors (TKIs). It is mandatory to have a better description to natural history of~     the disease. This study will be conducted by the Groupe Français de Pneumo Cancérologie~     (GFPC) up to 100 patients during 18 Months. Each center will have to define if re-biopsies~     are possible or not and explain why not.~   "
113176|NCT02086058|"~     The aim of this study (the hypothesis) is to identify differences in the gene expression~     profile in the bladder muscle and hereby gain greater knowledge about the muscular mechanisms~     that cause overactive bladder and daytime urinary incontinence in children older than 5~     years. A secondary aim is to examine how this gene expression profile differs from children~     with a neurogenic overactive bladder and how the gene expression profile changes from~     childhood till adulthood. Such new knowledge will result in a more precisely targeted and~     hence effective treatment of overactive bladder.~      The results will be obtained by retrieving bladder biopsies from children and adults~     suffering from an overactive bladder or a neurogenic bladder. These biopsies will undergo~     molecular analysis and the investigators will compare them with biopises from bladder healthy~     adults and children.~   "
113177|NCT02086045|"~     To evaluate the safety, performance and efficacy of the Elixir DESolve® Novolimus Eluting~     Bioresorbable Coronary Scaffold System (BCSS) in patients with a single de novo native~     coronary artery lesion designated the target lesion and up to one non-target lesion located~     in a separate epicardial vessel.~   "
113178|NCT02086032|"~     Investigators have found that sleeping disorder is an important problem in menopausal women.~      There have been papers reporting the effect of hormonal therapy on sleeping, but fews have~     reported the effect of different progestogens on sleeping quality. There is a need for more~     in-depth study and more conclusive evidence about the progestins which have the most~     beneficial effects on sleeping disorders in menopausal women.~      This study is going to collect the data from newly identified menopausal patients who are~     eligible for continuous estrogen-progestogen therapy for their climacteric treatment. The~     affects of the therapy will be monitored for 3 months.~   "
113179|NCT02086019|"~     For octogenarian patients with NSTEMI (non-ST segment elevation myocardial infarction) an~     invasive-guided strategy will prove superior to a conservative strategy with respect to a~     combined endpoint of all cause mortality and non-fatal myocardial infarction.~   "
113180|NCT02086006|"~     This prospective, consecutive enrolment, single-arm study will enroll up to 15 patients with~     single de novo, Type A lesions < 10 mm in length and located in a native coronary artery with~     a reference vessel diameter of 2.75 mm - 3.0 mm as measured by both offline QCA and IVUS. All~     patients will receive a 3.0 x 14mm DESolve Stent loaded with approximately 40 mcg of~     Myolimus.~        -  Angiographic and intravascular ultrasound (IVUS) will be completed for all patients at~          baseline and at 6 months.~        -  Optical Coherence Tomography (OCT) will will be completed for all patients at baseline~          and at 6 months.~        -  Multi-slice computed tomography (MSCT) will be conducted on all patients enrolled at 12~          and 24 months.~   "
113181|NCT02085993|"~     Cross-sectional study, observation made by healthcare professionals of subjects or~     caregivers, administering romiplostim at their first standard-of-care visit 4 weeks after~     training with the home administration training pack. Further observations can also be~     recorded in the study if made within 16 weeks of enrolment. Data will be collected from the~     subjects' dose diary at their first standard of care visit to ensure there were no problems~     with administration while not at the clinic.~   "
113182|NCT02085980|"~     The purpose of this study is to assess the safety and the efficacy of a laser in the~     treatment of vulvovaginal atrophy (VVA), that is to assess the change in the severity of the~     vaginal dryness symptom, by means of a visual analogic scale (10 cm VAS).~   "
113183|NCT02085967|"~     This study will be a single center, open-label, drug-drug interaction study in healthy male~     and female subjects. The study will consist of 2 parts. In Part A, the effects of~     steady-state dosing of a strong CYP3A inhibitor (itraconazole) or inducer (rifampin) on the~     pharmacokinetics of E2006 and metabolites will be assessed. Approximately 30 subjects will be~     sequentially assigned to 1 of 2 treatment groups to receive itraconazole or rifampin in equal~     numbers (approximately 15 subjects per group). The itraconazole treatment group will be fully~     enrolled before enrollment is initiated for the rifampin treatment group. In Part B, the~     effects of steady-state dosing of E2006 on the pharmacokinetics of midazolam, a substrate of~     CYP3A, plus bupropion, a substrate of CYP2B6, will be assessed in approximately 24 subjects.~     The 2 study parts can be conducted in parallel.~   "
113184|NCT02085954|"~     Stroke patients in the investigators rehabilitation unit follow gait trainings with~     robotic-assistive devices such as Lokomat. Patients able to walk alone are also assessed with~     3D gait analysis. The objective of this study is to assess the effects of gait training in~     Lokomat on biomecanic gait parameters in stroke patients.~   "
113185|NCT02085941|"~     This research study is evaluating a procedure called cryoablation (the removal of diseased~     tissue using extreme freezing temperatures) as a possible treatment for head, neck and spine~     tumors.~   "
113197|NCT02085785|"~     The purpose of this study is to pilot test a program to help overweight and obese individuals~     with a lower extremity amputation (LEA) lose weight and become more physically active. The~     investigators will randomize approximately 30 individuals to either a self-directed weight~     loss program (n=15) or a coached weight loss program (n=15). The primary purpose of this~     pilot study is to determine if a home-based weight loss/physical activity (PA) intervention~     is feasible in individuals with a LEA. MOVE-LEAP is a 20-week program that involves 11 phone~     calls from a health coach and a single home visit by a physical therapist.~      This pilot study aims to:~        1. test the feasibility of recruiting overweight/obese individuals with LEA into a~          randomized trial;~        2. assess whether the intervention can be delivered with high fidelity, and~        3. evaluate whether the intervention is acceptable to and safe as determined by participant~          feedback, participation and retention for outcome measures.~   "
113186|NCT02085928|"~     Lateral epicondylitis (LE) is the most common cause of lateral elbow pain. Intratissue~     percutaneous electrolysis (EPI technique) is a novel minimally invasive approach which~     consists in the application of a galvanic current through a puncture needle which produces a~     local inflammatory process in the soft tissue and the reparation of the affected tissue.~      The purpose of this study is to evaluate the clinical and ultrasonographic effectiveness of a~     multimodal program using the intratissue percutaneous electrolysis technique and exercises in~     the short term for patients with chronic lateral epicondylitis, and to determine whether the~     clinical outcomes achieved decline over time.~      This study is an observational one-way repeated measures design. 36 patients in a clinical~     setting presenting with lateral epicondylitis (mean age = 38, mean time since injury = 12.6~     months) received one session of EPI per week over 4-6 weeks, associated with a home program~     of eccentric exercise and stretching. The main outcome measures were severity of pain (VAS,~     digital algometer, Cozen and Thompson tests), disability (DASH questionnaire), structural~     tendon changes (ultrasound), hypervascularity (power doppler) and patient's perceptions of~     overall outcome (4-point scale). Measurements at 6, 26 and 52 weeks follow-up included~     recurrence rates (increase of severity of pain or disability compared to discharge), the~     perception of overall outcome and success rates. Paired Student t-tests and Chi squared tests~     were applied to data. Enrollment into this study ended in September 2012.~      All outcome measures registered significant improvements between pre-intervention and~     discharge. Most patients (30, i.e. 83.3%) rated overall outcome as 'successful' at 6 weeks.~     The ultrasonographic finding revealed that the hypoechoic regions and hypervascularity of the~     extensor carpi radialis brevis change significantly. At 26 and 52 weeks, all participants~     (32) perceived a 'successful' outcome. Recurrence rates were null after discharge, and at the~     6, 26 and 52 week follow-ups.~   "
113187|NCT02085915|"~     The forecast of the spontaneous infection of the liquid of ascites (ISLA) at the cirrhotic~     patient is still burdened by a heavy mortality. The fast diagnosis of the ISLA is thus an~     essential stake to improve the forecast.~      Investigators would so like to estimate the interest of the strip PeriScreen for the fast~     diagnosis of the ISLA at cirrhotic patients . Investigators plan to include 670 patients,~     what would allow to make out a will at least on ascites 2000 on about twenty centers for~     duration estimated of 12 months.~   "
113188|NCT02085902|"~     Since the recommendations of the French Society of Digestive Surgery 2010, cholecystectomy~     can be performed as outpatient surgery. This approach is difficult in many centers because of~     post operative pain and nausea/vomiting.~      The use of postoperative morphine may be responsible for the state of nausea. The use of~     ropivacaine allows a reduction of the morphine consumption and thus may allow the patient to~     have their surgery as an outpatient.~      Currently, ropivacaine is used randomly during the investigators surgeries. Initially, it was~     used for the infiltration holes trocar. In recent years, ropivacaine is used for the~     reduction of intra-abdominal postoperative pain. Its use is made of parietal surgery ( hernia~     ) in cholecystectomy and colonic surgery. This mode of administration is allowed to view the~     many publications made on this subject. Its use in the investigators daily surgery, however,~     has not been evaluated in ambulatory surgery.~   "
113189|NCT02085889|"~     Background: The association of fructose and lactose intolerance and malabsorption with the~     symptoms of different functional gastrointestinal disorders (FGID) is unclear. The mechanisms~     behind the multi-organ symptoms remain unclear. Both FGID and saccharide intolerances are~     common (>10% of any given population). Dietary modification based on intolerance diagnostics~     could provide an effective treatment for FGID, which are otherwise difficult to treat.~      Aim: To investigate the prevalence and interrelationships of fructose and lactose intolerance~     (symptom induction) and malabsorption (breath test gas production) and their association with~     clinical GI as well as non-GI symptoms in FGID and the outcome of standard dietary~     intervention. Mechanisms related to symptom genesis will be investigated using metabolomic~     analysis of plasma and urine by gas chromatography/time-of-flight mass spectrometry~     (GC/TOFMS).~      Methods: Fructose and lactose intolerance (defined by positive symptom index) and~     malabsorption (defined by increased hydrogen/methane) will be determined in successive male~     and female FGID patients in a single center using breath-testing. Symptoms will be recorded~     using standardised questionnaires and the Rome III criteria. The prevalence of the~     intolerances in the different FGID subgroups and the associations between breath testing~     results, clinical symptoms and the outcome of dietary modification will be assessed. Factors~     predictive of the outcome of dietary modulation will be screened for. GC/TOFMS will be used~     to assess the human and microbial metabolome in urine and plasma.~   "
113190|NCT02085876|"~     This is a single centre prospective open-label, non-randomised pilot study whose aim is to~     identify MRI parameters to better evaluate inflammation and liver fibrosis and thus, in the~     near future, to avoid the need for liver biopsy.~      To achieve this:~        -  The MRI study will be completed by adding two sequences: Measurement of T1 and multiecho~          T2*. The other data will be extracted from usual sequences.~        -  Part of the histological samples will be used for the weighted levels of fat and iron,~          and for the lipidomic study.~        -  Usual blood samples will be completed by samples for the serum library~   "
113191|NCT02085863|"~     This is a single center, randomized, double blind, placebo controlled, 2-way crossover~     drug-drug interaction (DDI) study to assess the effect of laquinimod on the PK and PD of~     ethinylestradiol (EE) and levonorgestrel (LNG) a commonly used oral contraceptive~     combination.~   "
113192|NCT02085850|"~     Aim 1: To determine the incidence of glaucoma in Ghana in subjects previously found to be~     non-glaucomatous in the Tema Eye Survey.~      Aim 2: To characterise the progression of glaucoma and the outcomes of subjects diagnosed~     with glaucoma in the Tema Eye Survey.~   "
113193|NCT02085837|"~     Improve health and outcome for people with late stage chronic kidney disease by providing~     patient centered nursing services in addition to a Nephrologist's routine patient care.~   "
113194|NCT02085824|"~     The purpose of this study is to determine which of the following drugs: enoxaparin,~     dabigatran and rivaroxaban causes least blood loss after total hip replacement (THR).~   "
113195|NCT02085811|"~     The aim of this retrospective study is to show that kyphoplasty is a reliable technique in~     the treatment of certain traumatic vertebral fractures.~      Patients will be selected from medical records archived at the Neuroradiology Department of~     Dijon CHU.~      An information sheet and questionnaire will be sent to patients together with a letter to ask~     them to have a radiographic examination.~      The radiographic images will be interpreted by two independent experts to evaluate the angle~     pf vertebral kyphosis.~   "
113196|NCT02085798|"~     Post-authorisation observational study to assess the evolution in normal clinical practice of~     patients recently diagnosed with myelodysplastic syndrome (MDS) or chronic myelomonocytic~     leukaemia (CMML), depending on the moment when active treatment is initiated. Subjects will~     be recruited from approximately 50 haematology sites in Spain.~   "
113198|NCT02085772|"~     This is a single-centre observational, prospective study carried out at the maternity unit of~     Dijon CHU. It will include pregnant women with a pre-conception BMI ≥ 30 kg/m² and will~     evaluate in these patients, the activation and migration capacities of circulating leukocytes~     and their association with the onset of spontaneous labour.~      Patients who meet the inclusion criteria will be informed about the study during their~     consultation at the 7th or 8th month, and their gynecologist will invite them to take part.~     If the answer is positive, the patients will be seen again at a specific consultation for the~     study between the 37th and 38the Weeks of amenorrhea at the maternity unit of Dijon CHU.~     During this consultation, the gynecologist will conduct a medical examination, while the~     Plurithematic clinical investigation center nurse will take a blood sample (3 x 6ml tubes and~     1 x 7ml tube).~      If labour has not started by 41 Weeks of amenorrhea, the patients will be seen at another~     consultation (consultation programmed in the usual follow-up of pregnancy) and a second blood~     sample (1 x 6ml tube and 1 x 7ml) will be taken.~      The patients will be followed until childbirth and will be split into two groups according to~     whether or not they gave birth after the onset of spontaneous labour.~   "
113199|NCT02085759|"~     Cytokines are chemicals that are naturally made by your body. Certain cytokine levels are~     changed in the blood of patients who develop allergies and/or asthma. Cytokine levels may~     also be changed in some individuals who are overweight or obese. The purpose of this study is~     to determine if certain cytokine levels differ based on a person's weight and whether or not~     they have allergies or asthma. Information gathered in this study will be compared to~     information gathered from subjects who have participated in another similar study for~     patients who have allergies and/or asthma.~   "
113200|NCT02085746|"~     This will be a descriptive study using patients from the Urogynecology and Urology University~     of South Florida Clinics and Urology clinic at Tampa General Hospital Healthpark on 30th~     Street to analyze the impact of demographics on the definition of being sexually active. It~     is believed one's demographics influence their definition of being sexually active.~   "
113201|NCT02085733|"~     Background:~      Children presenting with non-traumatic joint pain require different treatment depending on~     the cause of pain. Septic arthritis, which results from a bacterial infection in the joint,~     often requires a surgical procedure as well as a long course of antibiotics. In contrast,~     non-septic arthritis is typically treated by management of symptoms and observation. Current~     diagnostic standards involve microbiologic examination of fluid taken from the affected~     joint. This procedure can require the patient to be sedated, and the fluid culture analysis~     can take up to 72 hours. A single laboratory measure that could be easily obtained and~     quickly analyzed would aid in faster diagnosis, fewer diagnostic tests and lower cost of the~     diagnostic work-up for this condition.~      Recent research on septic arthritis has identified procalcitonin as a potential septic~     arthritis diagnostic indicator. Procalcitonin (PCT) is secreted by cells in the thyroid at~     higher levels when the body is facing infection. Procalcitonin levels rise slowly over the~     first two hours and peak at 24 hours. Levels rise 100-fold in the peripheral blood stream~     during this time frame. Several studies have indicated PCT is promising potential diagnostic~     indicator for septic arthritis. Unfortunately, many of these studies have relatively small~     sample sizes and very few involve pediatric populations. Additional study of PCT and septic~     arthritis in children will help evaluate the viability of PCT as a diagnostic indicator.~      Research Question:~      Can serum procalcitonin assist in clinical differentiation between bacterial (septic) and~     non-bacterial arthritis?~      Methods:~      Patients presenting with possible septic arthritis in the emergency department will be~     recruited for this study. Patients who consent to participate will receive the current~     standard for care, including IV placement, laboratory tests for Erythrocyte sedimentation~     rate (ESR),white blood cell count (WBC), and C-reactive protein (CRP), x-rays and~     consultation with pediatric orthopedics. Patients participating in the study will have a~     portion of the serum collected for typical diagnostic tests analyzed for PCT. Research~     assistants will collect data from medical records of participants, including lab and imaging~     results. Patients who do not undergo surgery will be contacted by phone within 7 days of~     their ED visit to confirm diagnosis.~   "
113202|NCT02085720|"~     Objective: Obstructive sleep apnoea syndrome (OSAS) is a common form of sleep-disordered~     breathing (SDB) causing sleep fragmentation, daytime sleepiness, cognitive function~     impairment, and poor health status in addition to increased risk of cardiovascular~     complications. OSAS is equally common among the middle-aged male Caucasian and Hong Kong (HK)~     Chinese populations with a prevalence of at least 4%. However, the prevalence of OSAS in the~     elderly population in Asia including HK is unknown.~      Study Design: A sleep questionnaire will be conducted for 1000 subjects aged at least 60 yrs~     in the elderly community centers focusing on symptoms of OSAS, subjective sleepiness,~     restless leg syndrome, and sleep-related habits and routines, in addition to past medical~     history and medications. Home sleep study (EMBLETTA) capable of recording sleep (a single EEG~     channel), respiratory events, snoring, respiratory efforts and oximetry will be performed on~     300 subjects randomly. Those who have negative or technical inadequate EMBLETTA study with a~     high pre-test probability of moderate to severe OSA will be invited to undergo hospital-based~     polysomnography for confirmation of their sleep apnoea status. Subjects with AHI>15/hr~     regardless of symptoms or those with AHI 5-15/hr plus comorbid conditions or excessive~     daytime sleepiness will be offered continuous positive airway pressure (CPAP) titration~     followed by CPAP treatment, with serial assessment of subjective sleepiness, quality of life,~     and cognitive function.~      Outcome measures: the prevalence rates of SDB (AHI>10, >15 and >30/hr), OSAS, and other sleep~     disturbances, such as restless leg syndrome (RLS). In addition, we will examine the factors~     which are predictive of the presence of SDB in this population, and assess the CPAP~     acceptance, compliance, and treatment outcome of those with OSAS.~   "
113203|NCT02085707|"~     Patients younger than 70 years with a displaced femoral neck are in serious conditions. The~     femoral neck fracture is associated with low activity levels, hip pain and substantially~     reduced quality of life. Relatively young individuals with low-energy fractures tend to have~     additional morbidity or lower bone quality. The literature indicates that 5 % of all~     displaced femoral neck fractures are in patients aged 55 - 70 years. Little research and lack~     of consensus and guidance about appropriate treatment of these patients renders choice of~     treatment, and the health economic aspect a great challenge. In this study the investigators~     aim to answer if patients aged 55 - 70 years with displaced and low-energy femoral neck~     fractures treated with a total hip arthroplasty leads to a better functional outcome than~     osteosynthesis, and can patient-related factors be identified that predispose for femoral~     fracture? It is a randomized multi center study of patients operated with either total hip~     arthroplasty or osteosynthesis in which functional outcome, complications and reoperations~     are compared for the 2 groups. Additional controls are done after 4 and 12 months; 2 and~     possibly after 3, 5, 10, 15 and 20 years. Map patient - related factors that predispose for~     displaced femoral neck fractures for patients aged 55 - 70 years. Map bone density measured~     with Dexa for two types of surgical procedures. Map complications and functional outcome~     after osteosynthesis or total hip replacement in patients aged 55 - 70 years with displaced~     femoral neck fractures.~   "
113204|NCT02085694|"~     A pilot study on efficacy of Lactobacillus CD2 lozenges in preventing oral mucositis (OM) by~     high-dose chemotherapy with autologous hematopoietic stem cell transplantation. To test~     whether the probiotic Lactobacillus brevis CD2 lozenges can reduce the incidence and severity~     of high-dose chemotherapy conditioning regimen induced OM in patients undergoing HSCT.~      Clinical activity will be defined as reduction in the incidence of chemotherapy induced OM in~     the patients undergoing HSCT.~   "
113207|NCT02085655|"~     Extranodal natural killer/T-cell lymphoma (ENKTL) is an aggressive form of non-Hodgkin's~     lymphoma and shows extremely poor survival. This prospective pilot study to evaluate the~     efficacy and safety of long-acting aspargase (pegylated aspargase, PEG-ASP) combined with~     gemcitabine and oxaliplatin (PASP -Gemox) treatment in this population.~   "
113208|NCT02085642|"~     The purpose of this study is to investigate if acupuncture is more effective than sham~     treatment in reducing lower extremity spasticity, and improving gait speed in the chronic~     phase of stroke recovery.~   "
113209|NCT02085629|"~     To collect evidence of the safety of administering donor-derived regulatory macrophage (M~     reg) preparations to living-donor renal transplant recipients in the context of an~     international European Union funded consortium aimed at evaluating cellular immunotherapy in~     solid organ transplantation (The ONE Study). It is anticipated that immune regulation induced~     by M reg therapy can eventually be used to reduce the need for conventional immunosuppression~     in transplant recipients.~   "
113210|NCT02085616|"~     The purpose of this study was to compare the effectiveness of the high-intensity proactive~     service with the low-intensity reactive service at the Swedish National Tobacco Quitline~     (SNTQ). Our hypothesis was that the effectiveness is about 5% higher in proactive than in~     reactive service.~      The structured treatment protocol is a mixture of motivational interviewing (MI), cognitive~     behavior therapy, and pharmacological consultation.The standard process at the SNTQ is to~     offer the client a choice of callback (proactive service) or no callback (reactive service).~     In the present study clients were not offered a choice, but were randomized to proactive~     service on even dates and to reactive service on odd dates. Data are collected through postal~     questionnaires, one baseline and one follow-up after 12 months.~   "
113211|NCT02085603|"~     This study is designed to assess whether a drug called Saracatinib is helpful in controlling~     bone pain from cancer. The investigators do not know if it will be, so half of the patients~     in the study will receive the drug and half will get placebo. Saracatinib is a drug that has~     been tried in patients with many different forms of cancer. It seems to have effects in bone~     and so the investigators hope that it will have an effect in those with cancer that has~     spread to the bones.~   "
113212|NCT02085590|"~     In the present study, we want to investigate whether BCG-vaccination enhances the innate~     immune response in humans in vivo during (single) human endotoxemia.~      In a future experiment we will investigate whether BCG-vaccination can reverse the tolerant~     state observed upon a second LPS administration.~      Our goal is to ultimately translate our results into clinic applications to reverse for~     example sepsis-induced immunoparalysis.~   "
113213|NCT02085577|"~     Patients with a daily use of opioids may develop higher postoperative pain levels, often need~     high doses of morphine and therefore their pain may be difficult to treat. A low dose of an~     old anesthetic drug, ketamine, administered during surgery can possibly reduce pain and~     morphine consumption in these patients. Our purpose is to investigate the effect of low dose~     ketamine on morphine consumption and pain after spine surgery in patients with a daily use of~     opioids. Our hypothesis is that low dose ketamine can reduce morphine consumption, pain and~     side-effects after spine surgery.~   "
113214|NCT02085564|"~     Background:~      The prevalence of gastroesophageal-junction cancer (cancer between the distal part of the~     oesophagus, and proximal part of the stomach/GEJ-cancer) is increasing in Denmark with more~     than 400 patients per year. The 5-year overall survival is less than 10% for the 2/3 of the~     patients, which are not considered resectable. Even for the 1/3, which is treated with~     surgical intervention and neoadjuvant chemotherapy the overall-survival is approximately 30%.~      The current Danish intended curative treatment consists of esophagectomy (surgical resection~     of the oesophagus with extended lymphadenectomy in abdomen and thorax (removal of~     lymphnodes)). Furthermore, perioperative chemotherapy consists of 6 series neoadjuvant~     chemotherapy (3 series before, and 3 series after operation).~      Unresectable patients receive palliative chemotherapy and no resection. Peritoneal washing~     cytology (PWC) is a recommended prediagnostic modality in gastric cancer patients. The method~     is used to detect free peritoneal cancer cells in the abdominal cavity even when macroscopic~     carcinomatosis is not present (i.e. the cancer has spread to other parts of the abdomen).~      Carcinomatosis can be found in up to 19% in gastric cancer patients often in the peritoneum.~     Positive peritoneal cytology (C1) can be identified in up to 7% of gastric cancer patients~     without metastases (C1M0), i.e. malignant cells can be identified in the peritoneal washing,~     but tumor spread has not been identified.~      Lots of studies indicate that C1-disease is an independent prognostic predictor for decreased~     survival, and increased recurrence rate, comparable with M1 patients (i.e. patients with~     distant metastases).~      The American Joint Committee on cancer recommends that C1 patients should be treated~     non-surgically - even when M1 disease has not been identified.~      On the basis of the above, PWC can be used to identify patients at greater risk for~     recurrence, and thereby not candidates for intended curative treatment.~      It is a fact, though, that C1M0 patients have a better survival than C1M1 patients.~     Currently, there is no level-1 evidence for specific treatment of C1M0 patients, why further~     research is required to approach this patient group in the most comprehensive way. The focus~     group of our study is therefore C1M0 patients, because of the difference in opinions.~     Furthermore most evidence is based on gastric carcinomas, why GEJ-cancer patients are the~     group, we will examine.~      Purpose:~      Peritoneal washing cytology (PWC) is performed as a standard prediagnostic modality at~     Rigshospitalet, for patients with gastric- and GEJ cancer, considered resectable at preceding~     multidisciplinary conference. Most studies in the past 20-years have focused on gastric~     cancer, and not specifically GEJ-cancer.~      This study will determine the usefulness of peritoneal washing cytology, and thereby~     verifying our own standard regarding GEJ-cancer. Furthermore, we will determine the effect of~     neoadjuvant chemotherapy on free peritoneal tumor cells and its correlation with overall~     survival.~      This study is intended as a validation of our own standard.~   "
113215|NCT02085551|"~     The primary objective of this retrospective case review study is to determine the safety and~     effectiveness of the Penumbra and Indigo Systems for mechanical thrombectomy in a cohort of~     patients with confirmed peripheral or visceral arterial occlusion or embolus. This is a~     retrospective, single arm, multi-center trial. Up to 100 patients at up to 10 centers will be~     enrolled. Angiographic assessment of vessel patency at immediate post-procedure as measured~     by TIMI scores and procedural serious adverse events are assessed and recorded.~   "
113216|NCT02085538|"~     Since the amount of palbociclib eliminated in urine is 6.9%, renal impairment is not expected~     to have much impact on palbociclib. However, the Federal Drug Administration (FDA) Guidance~     recommends a study in subjects with renal impairment when the drug is likely to be used in~     patients with impaired renal function. Palbociclib is intended for chronic use in cancer~     patients who may have some degree of impaired renal function.~   "
113217|NCT02085525|"~     A retrospective chart review of patients receiving concurrent chemoradiotherapy for~     oropharynx cancer was performed to compare clinical data for patients treated prior to the~     initiation of the NP clinic with those subsequently seen weekly in the NP clinic. The~     variables studied included; rate of hospitalization, dose completion and dose reductions. The~     results revealed an overall improvement in all variables for those patients seen in the~     weekly NP clinic.~      To further analyze this data a randomized, prospective study is proposed to validate the~     findings of the retrospective study. It is predicted that a weekly NP led clinic will~     decrease costly hospitalizations, increase patient treatment completion and improve overall~     patient quality of life and satisfaction.~   "
113218|NCT02085512|"~     The proposed work will evaluate the ability of neurocognitive retraining of executive~     functions and emotional regulation to reduce neurocognitive dysfunctions that follow trauma~     exposure and thereby prevent PTSD. The scientific rationale for this work is the hypothesis~     that impaired emotional regulation interferes with the expected recovery from the early~     responses to traumatic events, leading into a chronic disorder. In an initial phase the~     investigators will recruit 20 recently traumatized participants among trauma survivors~     admitted to a general hospital emergency room and test the planned intervention's acceptance~     and right 'dosing'. In the second phase the investigators will enroll 80 recent survivors~     into a randomized controlled study of the new intervention. The intervention will consist of~     web-based neurobehavioral training interventions that instill an emotional bias toward~     positive stimuli, improve emotion recognition and labeling, reduce resistance to emotional~     distraction, and enhance executive functioning. Control participants will complete web-based~     video games that do not have emotion-regulatory benefits. Outcome measures will include~     improvement in neurocognitive functioning and in PTSD symptoms.~   "
113219|NCT02085499|"~     The use of non-invasive methods of respiratory support to reduce complications of prolonged~     invasive mechanical ventilation in preterm infants has increased.~      The most common mode is nasal intermittent mandatory ventilation (NIMV). In NIMV, the~     interval between mechanical breaths is fixed and is determined by the frequency dialed by the~     clinician. Asynchrony between the infant's spontaneous breathing may exist since mechanical~     breaths delivered at fixed intervals can occur at different times over the inspiratory or~     expiratory phases of the infant's spontaneous breathing. Synchronized-NIMV is a mode similar~     to NIMV where the ventilator cycle is delivered in synchrony with the infant's spontaneous~     inspiration. This has been achieved by using techniques to detect the infant's spontaneous~     inspiration.~      The advantages or disadvantages of synchronized compared to non-synchronized NIMV remain to~     be determined.~      This study seeks to evaluate the effect of synchronized NIMV versus non-synchronized NIMV on~     ventilation and gas exchange in premature infants who require supplemental oxygen.~      The hypothesis is that the use of flow synchronized nasal intermittent mandatory ventilation~     (S-NIMV) in comparison to non-synchronized NIMV will improve ventilation and gas exchange and~     reduce breathing effort.~      The objective of the study is to compare the effect of flow synchronized-NIMV to~     non-synchronized-NIMV on tidal volume (VT), minute ventilation (VE), gas exchange, breathing~     effort, apnea and chest wall distortion in preterm neonates with lung disease.~   "
113220|NCT02085486|"~     The puncture of the vascular access in hemodialysis patients remains challenging even in the~     hands of experienced dialysis nurses. Unsuccessful punctures are associated with resource~     wastage, traumatism of the AV shunts, shortening of the effective dialysis time and poor~     patient satisfaction.~      The use of ultrasound by emergency department nurses and technicians without prior ultrasound~     experience in patients with difficult intravenous access showed in several studies to be very~     efficient. The investigators expect to achieve similar results in cannulation of AV shunts by~     the dialysis nurse staff after a short learning program.~      To show this, the investigators aim to conduct a trail where standard cannulation technique~     (inspection, palpation) will be compared with the ultrasound-assisted method in terms of~     efficacy, safety and patient satisfaction.~   "
113221|NCT02085473|"~     The aim of this study is to evaluate the pharmacokinetics and tolerability of tralokinumab~     when delivered at different flow rates to healthy volunteers.~   "
113222|NCT02085460|"~     To investigate the efficacy and safety of rebamipide liquid for chemoradiotherapy-induced~     oral mucositis in patients with head and neck cancer following administration of rebamipide~     and to determine the optimal dose of rebamipide.~   "
113223|NCT02085447|"~     This is a prospective study using a concierge model of customized adherence enhancement and~     long-acting injectable antipsychotic (CAL-Concierge) in 30 individuals with schizophrenia or~     schizoaffective disorder at risk for treatment non-adherence and for homelessness. Like the~     CAE-L approach, CAL-Concierge is expected to improve health outcomes among the most~     vulnerable of populations with schizophrenia but even more importantly, will demonstrate that~     it can be used to improve the efficiency and quality of care in typical practice settings.~   "
113224|NCT02085434|"~     The American Academy of Pediatrics (AAP) recommends a staged approach for pediatric practices~     to manage the growing problem of pediatric overweight and obesity, starting with Stage 1,~     Prevention Plus, which encourages families to improve basic lifestyle choices related to~     eating and activity in order to improve BMI status. This study will test the effectiveness of~     an innovative FITLINE telephone counseling program for overweight and obese 8-12 year olds~     seen in pediatric practices where nutritionists coach parents in improving their child's diet~     and physical activity, to reduce BMI. If found to be effective, the FITLINE program will~     provide a model for widespread implementation of Stage 1, Prevention Plus of the AAP expert~     committee recommendations through pediatric practices nationwide.~   "
113225|NCT02085421|"~     The proposed pilot study is a randomized controlled study to assess effectiveness of~     transcranial direct current stimulation (tDCS) to enhance cognitive remediation therapy in~     patients with psychotic disorders. tDCS. Patients will be randomized into two arms: active~     tDCS vs. sham tDCS. The active tDCS will be applied at a current of 1-2 mA (milliamperes) via~     two saline soaked electrode sponges (3 cm x 4.5 cm) applied to the side of the head. The~     investigators hypothesis is that the use of tDCS will enhance the improvement seen with~     cognitive remediation therapy.~   "
113226|NCT02085408|"~     This randomized phase III trial studies clofarabine to see how well it works compared with~     daunorubicin hydrochloride and cytarabine when followed by decitabine or observation in~     treating older patients with newly diagnosed acute myeloid leukemia. Drugs used in~     chemotherapy, such as clofarabine, daunorubicin hydrochloride, cytarabine, and decitabine,~     work in different ways to stop the growth of cancer cells, either by killing the cells or by~     stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill~     more cancer cells. It is not yet known which chemotherapy regimen is more effective in~     treating acute myeloid leukemia.~   "
113227|NCT02085395|"~     To evaluate the efficacy of SR-T100 gel by observing the lesion size (length x width x~     height) of human cutaneous squamous cell carcinoma in situ (Actinic Keratosis and Bowen's~     Disease) reduced at least 75%.~   "
113228|NCT02085382|"~     A randomized, controlled trial of Kangaroo Mother Care (KMC) to determine the effectiveness~     in increasing the rate of weight gain among low birth weight neonates.~   "
113229|NCT02085369|"~     Following obesity surgery gastric bypass (GBP) patients usually lose more than 50% of their~     former obesity within a relatively short time (~ 2 years). But knowledge about the underlying~     psychological and biological mechanisms of decline in body weight, however, is still lacking.~     This project intends to investigate whether obesity surgery is associated with patients'~     cognitive ability and / or gene expression and metabolomics.~   "
113230|NCT02085356|"~     This study will test the effectiveness of a behavioral intervention to increase Prevention of~     Mother-to-Child Transmission of HIV (PMTCT) protocol uptake among South African HIV positive~     pregnant women. This study will also determine whether the participation of male partners~     will have additional positive impact on PMTCT uptake. The intervention will utilize a~     combination of both gender-concordant groups and individual or couples counseling strategies,~     before and after birth. During antenatal care, the intervention will use a gender-concordant~     group format to address PMTCT information, HIV disclosure, coping with stigma, intimate~     partner violence, and adherence to the overall PMTCT protocol. Just prior to birth and~     following birth, the intervention will shift to individual or couples-based counseling,~     targeting medication adherence, safer infant feeding, and family planning. It is hypothesized~     that women attending the intervention will be more likely to properly take HIV medication~     before birth and provide it to their infants. Additionally, it is hypothesized that male~     partner involvement will further increase the likelihood that mothers will take their HIV~     medication as prescribed and provide it to their infants.~   "
113231|NCT02085343|"~     This study tests whether a single session of exposure therapy may be enhanced by the addition~     of anti-phobic actions beyond the mere fading of safety behaviors. A total of 100 acrophobic~     participants will be randomly assigned to receive standard exposure therapy (EXP), exposure~     therapy with safety behavior fading (EXP + SBF), exposure with safety behavior fading and~     anti-phobic actions (EXP + SBF + AA), or to a wait-list control group (WL).~   "
113232|NCT02085330|"~     Dementia is a very frequent cognitive disorder among elderly individuals. Its prevalence is~     about 15-20% of the population over the age of 65. The most common forms of dementia among~     the elderly demented patients are Alzheimer's disease (AD) (prevalence of 70%) and Vascular~     dementia (VD) (prevalence of about 30-40%).There is also a high rate (about 40%) of~     coexisting of AD and VD among the dementia patients, defined as mixed dementia.~      Mild Cognitive Impairment (MCI) is a pre-dementia phase of cognitive decline. It is also~     considered as a prodromal phase of both VD and AD. Its basic clinical features include:~     cognitive concern, reflecting a change in cognition, reported by the patient or informant~     (i.e., historical or observed evidence of decline over time), with objective evidence of~     impairment in one or more cognitive domains (i.e., by formal cognitive testing), as well as~     preservation of independence in functional abilities and not being demented (i.e., no~     significant impairment social or occupational functioning).~      Hyperbaric oxygen therapy (HBOT) has been investigated for treatment of numerous diseases for~     more than 300 years. The principal effect of HBOT is increasing the solubility of oxygen in~     plasma to a level sufficient to support tissues with minimal oxygen supply carried on by~     hemoglobin. Clinical studies published this year present convincing evidence that hyperbaric~     oxygen therapy (HBOT) can be the coveted neurotherapeutic method for brain repair. Thus, it~     seems that HBOT might be an efficient and clinically feasible method capable of increasing~     tissue/cellular oxygenation and effectively evoking neuroplasticity in the chronically~     vascular-lesioned areas during the post microvascular lesion phase.~      This is a prospective, randomized, control crossed over, study evaluating the effect of HBOT~     in patients suffering from Mild Cognitive Impairment and Vascular Subcortical Ischemia.~   "
113233|NCT02085317|"~     In this study the investigators have aimed to evaluate morphology and reactivity of cutaneous~     microcirculation in patients with lepromatous leprosy. Ten patients, without any other~     comorbidity were compared to ten controls without leprosy or any other comorbidity, using the~     Cytoscan® [orthogonal polarization spectral (OPS) imaging], Fourier analysis of laser Doppler~     signal to evaluate vasomotion (rhythmic spontaneous oscillation of arteriolar diameter) and~     laser Doppler flowmetry associated to iontophoresis of vasoactive substances (acetylcholine~     and sodium nitroprusside).~   "
113234|NCT02085304|"~     A glioblastoma (GBM) is the most common malignant primary brain tumor, yet it is not easy to~     control. Recent studies show that survival improves for patients who get aggressive surgery~     to remove a tumor before starting radiation (RT) and chemotherapy (chemo) treatment. Surgery,~     RT and chemo are part of regular cancer care for GBM. RT is usually done in daily doses 5~     days a week over about 6 weeks. Beams of radiation are aimed at the tumor site plus some of~     the normal brain tissue around the tumor area. GammaKnife® (GK) radiosurgery also delivers~     radiation but in a larger dose over one day. GK sends beams to a precise target (tumor~     location) and very little normal brain tissue that is nearby. This study will compare GK~     treatment to the usual RT treatment after surgery, and with chemo.~      We want to know:~        -  How well each treatment keeps the tumor from growing back.~        -  What the effects (good and bad) of the treatments are.~        -  How you rate your quality of life.~        -  How the treatment affects your ability to think, understand, reason, and remember.~        -  How you rate your ability to think, understand, reason, and remember.~        -  If using a certain type of MRI scan can show the difference between new tumor growth and~          changes caused by treatment.~        -  If certain features found in tumor cells can help doctors predict how tumors will~          respond to treatment.~   "
113235|NCT02085291|"~     Assess the effect of fluids and norepinephrine for mean arterial pressure titration to~     patients' usual level on the microcirculation of initial resuscitated hypertensive septic~     shock patients.~   "
113236|NCT02085278|"~     This is a clinical trial/study for patients diagnosed with brain arteriovenous malformation~     (AVM). An AVM is an abnormal connection between the arteries and veins of the brain. Patients~     considered for this trial are 21 years and younger with AVM suitable for embolization~     treatment (a procedure used to block the abnormal connection between the arteries and veins~     of the brain) with Onyx Liquid Embolic System (Onyx LES) or TruFill n-Butyl Cyanoacrylate~     (n-BCA) Liquid Embolic System (both are liquid substances used in the embolization procedure~     to block the abnormal connection).~   "
113237|NCT02085265|"~     To conduct a proof of concept study in patients with mild to moderate Alzheimer's Disease who~     have treated hypertension, in order to determine if there is less global brain atrophy over~     one year, as measured by ventricular enlargement as a primary outcome measure, when patients~     are randomized to treatment with an angiotensin receptor blocker compared to an Angiotensin~     Converting Enzyme inhibitor (ACEI).~   "
113238|NCT02085252|"~     The purpose of this study is to assess two treatment strategies (leuprorelin treatment and~     active surveillance without androgen deprivation) for indolent prostate cancer and to compare~     their therapeutic benefit for management of patients with low-risk, localized prostate~     cancer.~   "
113240|NCT02085226|"~     Title: A C E S Study: Can an arts based creative engagement intervention (CEI) following~     stroke improve psychosocial outcomes? A feasibility trial of a creative engagement~     intervention for inpatient rehabilitation.~      This is a feasibility randomised controlled trial of a novel intervention for stroke~     rehabilitation examining effects of participation in visual arts activities on psychosocial~     outcomes after stroke.~      The investigators hypothesise that participation in a visual arts based intervention (CEI)~     will improve stroke recovery variables, mood and self-esteem in stroke survivors receiving~     in-patient rehabilitation compared to viewing a portfolio of artwork.~      The results of the study will inform a sample size calculation for a full trial.~   "
113241|NCT02085213|"~     A retained placenta (RP) is a complication after a normal birth, which affects nearly 11,000~     women in the UK per year. This is where the placenta is not delivered spontaneously after~     giving birth. It is a major cause of postpartum haemorrhage (major loss of blood) which can~     lead to the death of the mother. The recommended treatment for RP is a surgical procedure -~     manual removal of placenta (MROP). This is a painful and unpleasant intervention for the~     women, involving additional hospital stay, and is an expensive outcome for the NHS. It is~     widely recognised that non-surgical management options for RP are limited and it has been~     recommended that research is needed into new medical treatments for RP. New effective~     treatments for RP would dramatically reduce the number of women requiring MROP with the~     operation being restricted to the small minority of women with particularly stuck placentae.~     The reduction in operative interventions would have cost benefits for the NHS and also for~     women in terms of increased satisfaction, less separation of mother and baby immediately~     after birth, and reduced morbidity.~      This study will try to prove the clinical and cost effectiveness of a known treatment for~     angina, Glyceryl trinitrate (GTN) used to treat RP. The investigators will compare GTN~     against a placebo (dummy treatment) in a randomised controlled blinded trial (GOT-IT).~      The GOT-IT Trial will be conducted in two phases. The first phase will involve an internal~     pilot study where the aim will be to test out and refine trial procedures in a small number~     of hospital sites. The second phase will be the main trial where recruitment will be extended~     to a larger number of hospitals in order to determine clinical and cost effectiveness.~   "
113242|NCT02085200|"~     The purpose of this study is to determine if stabilizing the scapula (shoulder blade) during~     a common shoulder stretch is more effective at improving shoulder range of motion than not~     stabilizing the scapula. Investigators hypothesize that scapular stabilization during~     horizontal adduction stretching will demonstrate greater gains in shoulder range of motion~     than stretching without scapular stabilization.~   "
113243|NCT02085187|"~     Chronic obstructive pulmonary disease (COPD) is a widespread disease that can have a major~     impact on the lives of individuals. An essential element in the treatment of COPD is~     rehabilitation of which supervised training is an important part. However, not all~     individuals with severe COPD can participate in the rehabilitation provided by hospitals and~     municipal training centres due to distance to the training venues and transportation~     difficulties. The aim of the feasibility study was to evaluate an individualised home based~     training and counselling programme via video conference to patients with severe COPD after~     hospitalization with regard to safety, clinical outcomes, patients' perception,~     organisational aspects and economic aspects.~   "
113244|NCT02085161|"~     The primary objectives of the study are to explore the effect of treatment with orally~     inhaled tiotropium + olodaterol fixed dose combination with and without exercise training,~     and tiotropium comparing to placebo, on top of behavioural modification in improving exercise~     capacity in patients with COPD~   "
113245|NCT02085148|"~     Dose escalation phase of the study :~      To define the safety profile, maximum tolerated dose (MTD) and recommended phase II dose~     (RP2D) of regorafenib administered orally as a single agent in a 3-weeks-on/1- week-off~     schedule in repeating cycles of 28 days in pediatric subjects with solid malignant tumors~     recurrent or refractory to standard therapy. To characterize the pharmacokinetics (PK) of~     regorafenib The dose escalation phase of the study has been completed.~      Expansion phase:~      To define the safety profile, MTD and the RP2D of regorafenib administered orally in~     combination with backbone chemotherapy (vincristine and irinotecan) at relapse in pediatric~     subjects with rhabdomyosarcoma (RMS) and other solid malignant tumors recurrent or refractory~     to standard therapy.~   "
113246|NCT02085135|"~     This is a Phase 3 study designed to evaluate the safety and tolerability of two titration~     schedules for ALKS 5461.~   "
113247|NCT02085122|"~     Introduction: Dyspnea and fatigue determine exercise intolerance in heart failure (HF)~     subjects, hampering performance in activities of daily living. In this context, noninvasive~     ventilation (NIV) has been used to minimize such impairment, increasing functional capacity~     Aim: To evaluate the impact of NIV on exercise performance in HF individuals. Methods: A~     randomized crossover clinical trial with allocation concealment consisted of two experimental~     phases: NIV and control, 7 days apart of each other. During NIV phase, 30 minutes of bi-level~     ventilation was performed. Any type of ventilator support was offered during control phase.~     Functional capacity was assessed by cardiopulmonary exercise test on a treadmill.~   "
113255|NCT02085018|"~     Idiopathic pulmonary fibrosis (IPF) is a disease of unknown cause in which areas of normal~     lung tissue are replaced by scars. As a result it becomes harder for the lungs to extract~     oxygen from the air. IPF is commonly progressive, and around 50% of patients diagnosed with~     the disease die after approximately 3 years. The most common, troublesome symptoms of IPF are~     breathlessness on exertion, and cough. No drug treatments have been unequivocally shown to~     improve the death rate, or to significantly impact upon symptoms, in IPF.~      In recent years it has been recognised that cough can be caused by small amounts of liquid~     coming up from the stomach and going down the wrong way into the lungs, a process commonly~     known as reflux. As liquid in the stomach is usually acidic, patients' lungs may repeatedly~     be exposed to small amounts of acid. Reflux is unusually common in IPF and could potentially~     contribute to the debilitating cough found with the disease. However there are many potential~     causes for cough in IPF.~      Stomach acid can be efficiently switched off by drugs called proton pump inhibitors, one~     of which is called omeprazole. If reflux of stomach acid does contribute to cough in IPF,~     omeprazole might be expected to reduce cough. The purpose of this study is therefore to test~     whether omeprazole does reduce cough in patients with IPF. Sixty patients with IPF will be~     randomly allocated to have 3 months of omeprazole or a placebo. Neither the patient nor the~     doctor will be aware which treatment has been given, ie this is a randomised double-blind,~     placebo--controlled trial. Patients' cough frequency will be measured before and after~     treatment and the change in cough frequency compared in those receiving omeprazole and those~     receiving placebo. Change in cough frequency is the main thing we aim to compare, but a range~     of other measurements will be assessed such as the numbers of patients eligible to take part,~     agreeing to randomisation and providing outcome data, patients' lung function, symptom~     scores, the amount of reflux, and the amount of inflammation in the lungs.~   "
113248|NCT02085109|"~     Rationale: Despite successful efforts to lower atherogenic serum low-density lipoprotein~     (LDL) cholesterol concentrations, a substantial residual cardiovascular risk is still~     present. An additive strategy to further lower this residual risk may be via raising~     high-density lipoprotein (HDL) cholesterol concentrations, and in particular those of its~     major protein constituent apolipoprotein A-I (apoA-I). However, recent evidence shows that~     raising HDL cholesterol (HDL-C) concentrations not always causes a reduction in~     cardiovascular disease (CVD) risk. To understand this it is important to know what are the~     targets and molecular mechanisms that underlie a shift to a HDL fraction with~     cardioprotective activities. There is increasing evidence that particularly the apoA-I~     proteins in the HDL fractions are atheroprotective. It is important to verify whether the~     effect of an intervention actually increases apoA-I production since that results in the~     formation of de-novo small pre-beta HDL particles that have full capacity to resorb~     cholesterol from the arterial wall and return this to the liver for secretion (reverse~     cholesterol transport). The investigators here propose to evaluate, in a double-blind human~     intervention study, the difference in intestinal apoA-I gene expression, of healthy subjects,~     after consumption of a high fat (HF) or low fat (LF) meal. Additionally the investigators~     propose to evaluate the effect of theobromine on intestinal apoA-I expression. Based on~     several studies, theobromine improved cardiovascular risk parameters among which an elevation~     in apoA-I and HDL cholesterol concentrations. It is however unknown whether this effect of~     theobromine originates from elevated apoA-I production, which suggest improved functionality,~     or decreased clearance, suggesting reduced functionality. The investigators therefore propose~     to also evaluate if the usage of theobromine is a better way to increase intestinal apoA-I~     mRNA and protein expression, than consumption of a HF meal. The investigators will do this in~     the same double-blind human intervention study. The theobromine will be added in a third arm~     in a LF condition.~      Study design: The proposed study will have a randomized, double-blind cross-over design. The~     total study duration will be 17 days, consisting of 3 experimental days with postprandial~     tests, each separated by a 1 week wash-out period.~      Study population: Ten apparently healthy male subjects, aged 18-60 years, without a history~     of any gastrointestinal disorders or complaints.~      Intervention: During the three experimental days, subjects will consume a milkshake: one HF~     milkshake, one LF milkshake and one LF milkshake supplemented with 850 mg theobromine. Total~     follow-up during each of the postprandial tests is 5 hours.~   "
113249|NCT02085096|"~     Problem-solving therapy programs have been shown to be effective among parents of children~     diagnosed with cancer. Efforts have been made to apply this same strategy to~     spouses/significant others of men diagnosed with prostate cancer. The purpose of this study~     is to test the efficacy of problem-solving therapy on the spouses of prostate cancer~     patients.~   "
113250|NCT02085083|"~     The transition from pediatric to adult IBD care can be stressful and wrought with challenges~     including access to care and establishment of new physician-patient relationships. There a~     few studies which characterize patterns of healthcare utilization during this critical period~     and its impact on outcomes. We hypothesize that uninterrupted healthcare utilization in~     academic centers and optimized communication with patients during the pediatric-adult~     transition period is associated with lower hospitalizations and surgery. This hypothesis will~     be addressed by a randomized clinical trial to determine the impact of monthly regular~     telephone contact with an IBD Registered Nurse versus standard of care during the~     pediatric-adult transition period. Outcomes will include healthcare utilization,~     health-related quality of life, patient satisfaction, and treatment adherence over 12 months~     of follow-up. Randomization and analyses will be stratified by whether subjects were~     transferred to adult care in an academic center or in a community practice. We hope that this~     research will facilitate optimal delivery of healthcare during the pediatric-adult~     transition.~   "
113251|NCT02085070|"~     The purpose of this trial is to study the activity of MK-3475 in untreated brain metastases~     from melanoma or non-small cell lung cancer.~   "
113252|NCT02085057|"~     Individuals with anorexia nervosa (AN) have long been observed to demonstrate symptoms in~     common with obsessive-compulsive disorder (OCD), in particular, an obsessive fear of normal~     weight leading to dangerous food restriction, as well as many compulsive rituals about food.~     Both AN and OCD are seriously handicapping and often resistant to conventional therapies.~     Given that the two conditions often co-occur and are associated with still unknown genetic~     risk factors, the aim of this project is to identify their shared and distinct patterns of~     brain activity.~      The investigators propose to use functional magnetic resonance imaging to compare brain~     response among adolescents with AN, OCD, and age-matched healthy individuals. Specifically,~     this study will investigate function of distinct brain circuits related to core aspects of~     these related disorders. The investigators use three tasks related to set shifting, global~     vs. local processing, and reward. Based on evidence of deficits in cognitive flexibility and~     ability to change behavior, the investigators hypothesize that adolescents with AN and with~     OCD will show hypoactivity of frontostriatal circuitry during cognitive tasks, and~     adolescents with AN will show hyperactivity in limbic regions in a reward task.~      This study is the first to directly compare brain activation patterns using functional~     neuroimaging in AN and OCD. The goal is to determine how abnormal brain activity relates to~     symptom formation, what accounts for shared characteristics amongst these disorders, and~     whether deficits in specific circuitry underlie their unique defining features. The study of~     shared and unique elements of functional brain circuitry reflects a new, emerging approach to~     the classification of psychiatric illness, one based on identifying unique combinations of~     biological risk factors that link related conditions. This approach is widely believed to be~     a critical step forward in developing more brain-relevant targeted strategies for~     preventative interventions.~   "
113253|NCT02085044|"~     The hypothesis for the study is that 12 months of a Ready-To-Use Supplementary Food (RUSF)~     distributions have a greater impact on children's health than the standard RUSF distributions~     during the hunger gap period (june to september). We estimated that the 12 month RUSF will~     decrease the incidence of severe acute malnutrition by 33% compared to an administration only~     during the hunger gap period (4 month a year).~   "
113254|NCT02085031|"~     -  To date, Roux-en-Y esophagojejunostomy transabdominal extracorporeally by circular~          stapler was the most common used method during laparoscopy-assisted total gastrectomy~          for gastric cancer, even though it was not totally laparoscopic surgery in which~          intracorporeal anastomosis should be performed.~        -  To gain potential clinical benefits from a smaller length of minilaparotomy and an~          easier anastomosis technique than extracorporeal anastomosis, intracorporeal Roux-en-Y~          anastomosis using a transorally inserted anvil (OrVil™) during totally laparoscopic~          total gastrectomy was adopted by experienced surgeons recently.~        -  However, the safety of intracorporeal Roux-en-Y esophagojejunostomy using a transorally~          inserted anvil (OrVil™) has not yet been evaluated. Thus, the study comparing the safety~          of intracorporeal versus extracorporeal Roux-en-Y esophagojejunostomy by circular~          stapler based on a well designed randomized controlled trial is needed.~   "
113256|NCT02085005|"~     Primary Objective:~      Efficacy: To assess the progression-free survival rate at 10 months in patients on~     maintenance therapy with capecitabine plus aflibercept.~      Secondary Objectives:~      To evaluate:~        -  Efficacy: Progression Free Survival (PFS)~        -  Efficacy: Overall Survival (OS)~        -  Efficacy: Objective Response Rate (ORR) as per Response Evaluation Criteria In Solid~          Tumors (RECIST version 1.1) criteria~        -  Health related Quality of Life (HRQL): EORTC QLQ-C30 scores and EQ5D-3L~        -  Safety~      Exploratory Objective:~      To collect blood and tumor samples to perform investigations for potential biomarker testing.~   "
113342|NCT02083874|"~     Single subject repeated measures design of an open label administration of Cannabidiol (CBD)~     to 5 participants withdrawing from cannabis use in an inpatient setting. 300mg of CBD will be~     administered once on day 1, twice on days 2-5 and once on day 6. Participants will be~     discharged on day 7. CBD will be administered orally in capsules.~   "
113257|NCT02084992|"~     This study will randomize participants with a diagnosis of congestive heart failure and at~     least one risk factor for hospitalization to either a tablet computer and web based disease~     management program or a telephone based disease management program. Both interventions are~     home based with heart failure education and symptom monitoring provided by nurse managers.~     The nurse managers are in close communication with both the participants and the~     participants' physicians . The components of the disease management program have been~     developed at Tufts Medical Center and the New England Quality Care Alliance with studies~     showing improved clinical outcomes, including reduced hospitalizations. The goal of this~     study is to transition this successful home monitoring and disease management program to a~     tablet computer and web-based implementation to both improve clinical outcomes (reducing~     hospitalizations and improving self-perceived health status) and improve provider-patient~     satisfaction. We hypothesize that the tablet computer based disease management will decrease~     heart failure hospitalizations.~   "
113258|NCT02084979|"~     This two-year randomized controlled trial of clinical outcomes seeks to evaluate the~     superiority of the asynchronous telepsychiatry (ATP) consultation model on access, quality,~     cost and outcomes of care over the usual care for adults referred from primary care clinics~     for psychiatric evaluation and treatment.~   "
113259|NCT02084966|"~     Optical coherence tomography (OCT) is a rapidly emerging imaging modality that can function~     as a type of optical biopsy, providing non-invasive cross-sectional images of tissue~     architectural morphology in situ and in real-time. This proposal will demonstrate that OCT~     has the ability to provide novel and valuable histopathological information regarding donor~     kidneys that can be used to predict post-transplant renal function. These investigations will~     result in a major breakthrough in increasing the number of healthy kidneys available for~     transplantation by making the most efficient use of available donor kidneys, eliminating the~     possible use of bad donor kidneys, providing an accurate measure of expected post-transplant~     renal function, and allowing better distinction between post-transplant immunological~     rejection and ischemic-induced acute renal failure.~   "
113260|NCT02084953|"~     The purpose of this study is to determine whether BMS-791325 has an effect on the~     electrocardiogram (ECG) interval QT corrected for Fridericia's method (QTcF).~   "
113261|NCT02084940|"~     PCOS is a common endocrinopathy affecting 5-10% of women in their reproductive age~     characterized by hyperandrogenism, chronic anovulation and polycystic ovaries. This syndrome~     is a serious problem in IVF since there is a high risk of developing ovarian hyperstimulation~     syndrome (OHSS) during ovarian stimulation with gonadotropins. The introduction of GnRH~     antagonist in IVF has reduced the incidence of severe OHSS, still maintaining a good ovarian~     response and pregnancy rate. Recently, a long acting GnRH antagonist, Degarelix, was~     introduced for prostatic cancer treatment. Furthermore a recent paper reported its use also~     for the induction of multiple follicular growth in a program of oocyte donation. The aim of~     this study is to evaluate the feasibility of GnRH antagonist depot use in a protocol of~     controlled ovarian hyperstimulation in PCOS women at risk of developing OHSS in IVF cycles.~   "
113262|NCT02084927|"~     The aim of the current study is to evaluate, in a prospective cross-over, randomized study,~     the effect of hyperbaric oxygen therapy (HBOT) on patients with chronic neurological deficits~     and cognitive impairment after anterior skull base meningioma tumor removal.~   "
113263|NCT02084914|"~     Research question:~      Population: women with unexplained infertility. Intervention: endometrial scratching by~     pipelle for women with unexplained infertility.~      Comparison: to compare with non endometrial scratching for women with unexplained~     infertility.~      Outcome: the biochemical pregnancy rate.~      Research hypothesis:~      Null hypothesis: there is no difference in the rate of pregnancy between scratching and non~     endometrial scratching in women with unexplained infertility.~      Alternative hypothesis: there is difference in the rate of pregnancy between scratching and~     non endometrial scratching in women with unexplained infertility.~   "
113264|NCT02084901|"~     The use of a biodegradable polymer has the potential to reduce the sustained inflammatory~     response of the arterial wall, facilitating re-endothelialization and minimizing the risk of~     thrombus formation and late restenosis. In the study, we are going to two biodegradable~     polymer stents, Orsiro and BioMatrix, especially regarding the stent strut coverage by~     optical coherence tomography at 3 months after stent implantation.~      The primary objective of this study is to test the hypothesis that Orsiro is non-inferior to~     Biomatrix in terms of stent strut coverage by optical coherence tomography at 3 months. The~     secondary endpoint is clinical outcomes up to 1 year.~   "
113265|NCT02084888|"~     The purpose of this study is to determine the prognostic impact of the presence of chronic~     total occlusions (CTO) of the coronary arteries in patients undergoing coronary angiography~     and PCI.~   "
113266|NCT02084875|"~     This study will evaluate the drug behavior and safety of a single dose of the 11 milligram~     tofacitinib (CP-690,550) modified-release formulation in 24 healthy volunteers when taken~     after eating a high fat meal (the effect of food). This will be compared to the drug behavior~     and safety of a single dose of the 11 milligram tofacitinib (CP-690,550) modified-release~     formulation when taken after a 10 hour fast.~   "
113267|NCT02084862|"~     TRACHUS trial is a randomized non-inferiority trial designed to evaluate the safety and~     efficacy of ultrasound guided percutaneous tracheostomy compared to bronchoscopy guided~     percutaneous tracheostomy.~   "
113268|NCT02084849|"~     The purpose of this study is to find out if radiology tests of the kidneys as opposed to~     glomerular filtration (GFR) tests (GFR test - a lab test that measures kidney function)~     follow progression of polycystic kidney disease (PKD) the best. PKD patients at risk for~     progression to renal failure (dialysis or transplantation) have been identified and include~     those who have been diagnosed with high blood pressure early, the presence of the PKD1 gene~     (the inherited abnormality responsible for the majority of PKD), men as opposed to women,~     those with episodes of visible blood or increased protein in their urine, and women who have~     experience more than three pregnancies. Individuals who are diagnosed with PKD in the first~     year of life or in utero (before birth) are also at high risk for progression to renal~     failure.~      This study will also facilitate understanding of human diseases at the cellular and molecular~     level. We will be identifying genetic factors that may influence the severity of polycystic~     kidney disease (PKD). You are being asked to provide a sample of blood for the purpose of DNA~     or other biochemical analyses.~   "
113269|NCT02084836|"~     Obesity is associated with increased risk for mortality, atherosclerotic cerebrovascular~     disease, coronary heart disease, colorectal cancer, hyperlipidemia, hypertension, gallbladder~     disease, and diabetes mellitus, resulting in over 111,000 deaths annually in the United~     States (Calle et al., 1999; Flegal et al., 2005). In the US, 65% of adults are overweight or~     obese (Hedley et al., 2004). Unfortunately, the treatment of choice for obesity (behavioral~     weight loss treatment) only results in a 10% reduction in body weight on average and most~     patients regain this weight within a few years (Jeffery et al., 2000). Further, most obesity~     prevention programs do not reduce risk for future weight gain (Stice, Shaw, & Marti, 2006).~     The limited success of treatment and prevention interventions may be due to an incomplete~     understanding of the processes that increase risk for obesity. Recent data suggest that obese~     adults show abnormalities in reward from food intake and anticipated food intake relative to~     lean adults, but the precise nature of these abnormalities is unclear and it has not been~     established whether these abnormalities predate obesity onset or are a consequence. It is~     vital to elucidate risk factors for obesity onset to advance understanding of etiological~     processes and determine the content of prevention and treatment programs.~      The goals of this study are to (1) determine whether adolescents at high-risk for obesity, by~     virtue of having two obese parents, show abnormalities in reward from food intake~     (consummatory food reward) and anticipated reward from food intake (anticipatory food reward)~     compared to adolescents who are at low-risk for obesity, (2) determine whether abnormalities~     in consummatory and anticipatory food reward increase risk for weight gain and obesity onset,~     (3) examine moderators that may amplify the relations of consummatory and anticipatory food~     reward to unhealthy weight gain, and (4) examine changes in consummatory and anticipatory~     food reward in those participants who show obesity onset relative to those not showing~     obesity onset.~   "
113270|NCT02084823|"~     Most studies of cancer stem cells (CSC) involve the inoculation of cells from human tumors~     into immunosuppressed mice, preventing an assessment on the immunologic interactions and~     effects of CSCs. In this study, the investigators examined the vaccination effects produced~     by CSC-enriched populations from histologically distinct murine tumors after their~     inoculation into different syngeneic immunocompetent hosts. Enriched CSCs were immunogenic~     and more effective as an antigen source than unselected tumor cells in inducing protective~     antitumor immunity.Immune sera from CSC-vaccinated hosts contained high levels of IgG which~     bound to CSCs, resulting in CSC lysis in the presence of complement.CTLs generated from~     peripheral blood mononuclear cells or splenocytes harvested from CSC-vaccinated hosts were~     capable of killing CSCs in vitro. Mechanistic investigations established that CSC-primed~     antibodies and T cells were capable of selective targeting CSCs and conferring antitumor~     immunity.~   "
113271|NCT02084810|"~     This trial is conducted in Europe. The aim of the trial is to investigate the bioequivalence~     of eptacog alfa A 6 mg and NovoSeven® in healthy male subjects.~   "
113272|NCT02084797|"~     This primary aim of this study was to critically assess whether or not sweat water content~     and sodium concentration were acutely regulated by dynamic changes in antidiuretic hormone~     (arginine vasopressin or AVP) acting on the Vasopressin 2 receptor (V2R) during exercise.~     Secondary aims were to evaluate running performance and core temperature to further~     characterize the role of AVP in the coordinated balance of fluid and temperature homeostasis~     during exercise. The primary hypothesis was that activation of the V2R in sweat glands would~     result in water reabsorption and fluid conservation during endurance exercise.~   "
113273|NCT02084784|"~     The purpose of this study is to compare the sentinel lymph node (SLN) detection rate of early~     breast cancer patients between using Indocyanine green (ICG) and Methylene blue with a novel~     surgical navigation system.~   "
113274|NCT02084771|"~     The purpose of this pilot trial is to determine the safety and feasibility of using oral salt~     and water loading compared to intravenous saline for the prevention of contrast-induced acute~     kidney injury in patients with chronic kidney disease receiving a contrast-enhanced CT scan.~   "
113275|NCT02084758|"~     Each subject will consume (in a randomized fashion) both the intervention beverage (nitrate~     solution) and the placebo, separated by a 1 wk washout period. The investigators will test~     the hypothesis that 7 days of dietary nitrate supplementation will improve metabolic~     efficiency in patients with COPD compared to the placebo.~   "
113276|NCT02084745|"~     Introduction:~      Boston keratoprosthesis (KPro) is a piece of specialized plastic that replace sick cornea~     (transparent structure at the front of the eye) in patients who have failed or those who are~     expected to have poor results with traditional corneal transplantation.~      While the Kpro can offer dramatic improvement in vision, it is also associated with several~     complications. Glaucoma (optic nerve damage due to high pressure inside the eye) is one of~     the most common complications after KPro surgery and can potentially cause irreversible~     vision loss.~      The implantation of a glaucoma drainage device (GDD), a tiny tube that drains the liquid~     inside the eye by bypassing the natural drainage system, is an effective option to lower the~     eye pressure in patients with KPro. Given the frequency and potentially devastating effects~     of glaucoma among KPro patients, some surgeons recommend to put in a GDD as a preventative~     measure. However, there is no consensus on when is the best timing to perform such surgery in~     relation to the Boston Kpro surgery.~      Hypothesis:~      For patients undergoing the Boston KPro surgery, implanting a GDD simultaneously, at the time~     of surgery, is more efficacious than at 6 months later, in the prevention of the progression~     of glaucoma and in maintaining better visual functions.~      Methods:~      We aim to recruit 40 patients over 4 years. Recruited patients will be randomly assigned to 2~     groups: 1) simultaneous GDD implantation at the Boston KPro surgery, and 2) GDD implantation~     6 months after the Boston KPro surgery.~      Once recruited, patients will be followed before the KPro surgery, postoperative day 1, week~     1, month 1, 3, 6 and 12. Standard ophthalmological exam will be performed at each visit.~     Additional non-invasive glaucoma tests and evaluation (visual fields and optic nerve photo)~     will be performed on day 1, month 1, 3, 6 and 12.~      For patients assigned to group 2, a GDD will be implanted 6 months after the KPro surgery.~     They will have additional follow-ups on post-GDD surgery day 1, week 1 and month 1.~      Results of visual acuity, visual fields, optic nerve evaluation and complications will be~     compared between the two groups to determine the better timing of GDD implantation.~   "
113277|NCT02084732|"~     Differentiated thyroid cancer includes papillary, follicular, Hurthle cell, and~     C-cell/medullary carcinoma. Even though incidence is relatively low (1% of all neoplasms), a~     rise in this disease has been recorded in the country (The Atlas of Cancer Mortality in~     Colombia, 2010).~      Although this disease has a low rate of attributable mortality, the costs arising from~     treatment, monitoring, and disabilities among affected patients and their families are high~     for the health system.~      The therapeutic approach to differentiated thyroid cancer once it starts progressing is~     limited; there are no truly favorable treatment options for patients with advanced thyroid~     cancer: available options include surgery, radiotherapy, and radioactive iodine therapy.~      Molecular biology now allows the identification of the effects of mutations and alterations~     in the proteins that participate in cell signaling which account for dedifferentiation,~     invasiveness, and the progression of neoplastic cells.~      VEGFR (vascular endothelial growth factor receptor) is one of the main molecules to be~     addressed by targeted molecular therapy. Its increased expression in differentiated thyroid~     cancer has been demonstrated and has been associated with increased growth, invasiveness, and~     shorter recurrence-free survival.~      Different agents are effective against this tyrosine kinase receptor; nevertheless, taking~     into account that it is not solely responsible for tumor progression, according to clinical~     study results, it is more reasonable to use non-selective tyrosine kinase inhibitors such as~     sorafenib and motesanib. These inhibitors have already been tested in phase II studies.~      Results from recent phase II research studies using these emerging treatment options have~     shown important effects in the therapeutic approach to other solid neoplasms.~      Information about the safety of this type of treatment is limited; a need for information~     regarding the use of new therapeutic approaches in Colombia is one of the contributions that~     the National Institute of Cancer can make to the country through this study.~   "
113317|NCT02084199|"~     This will be an open label study to assess the influence of renal impairment on the~     pharmacokinetics (PK) of GLPG0634 and its metabolite after once daily oral administrations of~     100 mg GLPG0634 for 10 days in subjects with renal impairment and matched healthy controls.~      Also, safety and tolerability of once daily oral doses of GLPG0634 for 10 days in subjects~     with renal impairment and matched healthy controls will be evaluated.~   "
113278|NCT02084719|"~     Rapid tests are increasingly used in medical practice, notably to screen for HIV. Their use~     has been associated with a faster linkage to care and lower rates of loss to follow up. Rapid~     tests are also well accepted by patients and clinicians.~      No rapid test is currently approved in Canada for screening of hepatitis C. Hepatitis C~     diagnosis is done through based on blood testing and the screening algorithm may require up~     to 3 visits to clarify the hepatitis C status.~      The Oraquick HCV test is a rapid test done on blood or saliva that can replace the first step~     of the regular screening algorithm. With this test the initial screening and the confirmation~     test can be done in one visit.~      The primary endpoint of this pilot-project is to evaluate clinical characteristics of~     Oracquick HCV (sensitivity, specificity, positive and negative predictive values) and to~     compare them to those of the standard screening algorithm in a population of active or~     ex-users of injected drugs. The project also intend to evaluate if the rapid test can reduce~     the rates of loss to follow up and increase the linkage to hepatitis C specialized care. This~     last endpoint will be evaluated through phone call follow up 6 months after the screening.~      One hundred and fifty patients will be included. Half will be tested with the standard~     algorithm and the Oraquick HCV test (group A) and half will be tested only with the standard~     algorithm.~      Results of group A will be used to determine the clinical characteristics of Oraquick HCV.~     Results of groups A and B will be used to evaluate rates of loss to follow up, costs avoided~     by the use of the rapid test and linkage to care of infected patients.~   "
113279|NCT02084706|"~     Jet-injection (J-tip) is a rapid, minimally invasive delivery system that can be used for the~     subdermal injection of lidocaine solution for anesthetic purposes. The device has been found~     effective in pain reduction during IV catheterization in adults and children and lumbar~     puncture in children when compared to placebo saline-jet injection. [1-4].~      We believe that administering local anesthetic via J-tip prior to triamcinolone(40 mg/ml)~     injection could mitigate pain that occurs during and immediately following injection while~     preserving the post-injection pain relief of anesthetic injection. Furthermore, pre-placement~     of the jet-injected local anesthetic may obviate the need for the inclusion of local~     anesthetic into the triamcinolone injection. This would decrease the amount of fluid~     injected, which could have positive pain modulation by decreased tissue disruption.~      Objective: To evaluate the effectiveness of needle free jet injection (J-tip) administration~     of 2% lidocaine in reduction of the pain experienced during trigger digit 40 mg/ml~     triamcinolone injection.~      Hypothesis: Needle free jet injection (J-tip) administration of 2% lidocaine will prove an~     equal or superior means of pain reduction when compared to 2% lidocaine injection in the~     setting of trigger digit triamcinolone injections.~   "
113280|NCT02084693|"~     Evaluate Survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate.~   "
113281|NCT02084680|"~     Introduction There is compelling evidence for scheduled home visits to improve newborn~     health. There is also a growing wealth of evidence to support the use of mobile phones as a~     public health tool in low and middle-income countries. UNICEF and WHO have recommended~     implementation of home visits for newborn care improvement. In sub Saharan Africa the~     evidence for a combined scheduled home visit and mobile phone technology to improve neonatal~     health is lacking. In this study the investigators aim to determine the effect of scheduled~     home visits by Community Health Workers (hereafter referred to as Village Health Teams-VHTs)~     combined with mobile phone consultations on newborn care in Masindi, Uganda.~      Methods This is a community intervention trial to be conducted in Masindi and Kiryandongo in~     Uganda from May 2013 to June 2014. A mixed method data collection technique will be used. Our~     overarching hypothesis is that survival of the newborn requires a continuum of care from~     pregnancy to the newborn period. Eight health centres each will be randomly allocated to the~     intervention arm and a control arm. Five villages will be randomly selected from each of the~     catchment areas of the intervention health centres and one VHT purposively selected from each~     of the villages. Intervention arm will receive VHTs equipped with mobile phones making four~     scheduled home visits to women while the control arm will receive the standard care for~     prenatal and immediate newborn education. VHTs will discuss care for the pregnancy, danger~     signs in pregnancy, birth preparation, acquiring needed items for delivery and recommended~     newborn care practices. VHTs can also make instant telephone consultations with the midwife~     for a second opinion. A closed caller group for the mobile telephone consultation is already~     negotiated with Mobile Telephone Network (MTN) a mobile phone service provider to allow lower~     tariff rates. Our primary outcome variables of interest are hygienic cord care (specifically~     application of substances on the cord), thermal care (specifically delayed bathing of the~     baby soon after birth), initiation of breastfeeding within one hour and avoiding pre-lacteal~     feeds. Secondary outcomes like completed four antenatal visits, institutionalized delivery~     were also assessed.~   "
113282|NCT02084654|"~     Exenatide, a GLP-1 agonist approved for lowering blood glucose concentrations in patients~     with type 2 diabetes, has been associated with restoration of the first-phase insulin~     response when administered intravenously to patients with type 2 diabetes. In longer clinical~     trials, it is associated with progressive decreases in body weight, and improvement in the~     dyslipidemia that characterizes insulin resistance, although insulin resistance was not~     quantified. The investigators will seek to determine whether exenatide would have similar~     effects in individuals who were not diabetic. in particular, the drug effect on beta cell~     function and insulin sensitivity would be subject to less confounding by changes in blood~     glucose in the prediabetic population, allowing for clearer evaluation of the physiological~     effects of the drug on these metabolic endpoints. The investigators will compare 2 groups of~     prediabetic insulin resistant individuals, all on a weight loss diet and one group on~     exenatide and the other on placebo. The investigators will evaluate restoration of first~     phase insulin response, potential glucose lowering effects, including both reversal of~     prediabetes and hypoglycemia, and improvement in insulin resistance.~   "
113283|NCT02084641|"~     Obesity has become an epidemic worldwide. Data from our laboratory and others demonstrate~     that most of the excess morbidity from obesity is related to insulin resistance (IR). While~     total adiposity correlates with insulin resistance, not all obese individuals are IR. When~     obese IR individuals lose weight in response to caloric restriction, even moderate loss of~     body fat results in improved insulin sensitivity (IS). With massive weight loss, either~     dietary or surgical, even the most IR individuals can completely reverse their insulin~     resistance. But why is one individual IR at a BMI of 26 and another IS at a BMI of 35? There~     must be differences in the manner in which adipose cells/tissue respond to caloric excess and~     weight gain. One potentially unifying hypothesis with regard to obesity-associated insulin~     resistance is that those individuals who fail to respond to caloric excess/obesity with~     adequate adipocyte differentiation and expanded subcutaneous fat storage capacity develop~     increased circulating FFAs, ectopic fat deposition, stress on adipocytes, triggering~     localized and systemic inflammation and ultimately insulin resistance in skeletal muscle.~      Clearly, the best way to examine the human response to obesity is to challenge overweight~     individuals with the need to store excess triglyceride in adipose tissue. Specific aims are:~        1. Test the hypothesis that impaired adipogenesis and fat storage capacity are associated~          with insulin resistance by comparing 1) cell size distribution; 2) gene markers of~          adipose cell differentiation; 3) differentiation of isolated preadipocytes in IR-prone~          vs IS individuals subjected to caloric excess.~        2. Determine if circulating (daylong FFA, two-stage Insulin Suppression Test) and ectopic~          fat (MRI liver, CT abdomen) are worsened to a greater degree in IR-prone vs IS~          individuals subjected to caloric excess.~        3. Determine whether differences in inflammation and/or innate or adaptive immune response~          are associated with insulin resistance by comparing differences in resident dendritic~          cells, macrophages and their activation profiles, changes in T-cell subpopulations, and~          other inflammatory mediators in IR-prone vs IS individuals who are subjected to caloric~          excess via overfeeding.~        4. Exploratory: Evaluate IR-prone vs IS individuals for evidence of hypoxia and~          insufficient angiogenic response in response to caloric excess.~   "
113284|NCT02084628|"~     This is an open-label, multi-center study involving babies 0-2 months of age who have liver~     problems (pathology) and need to have their liver and possibly, the bile ducts imaged using~     magnetic resonance imaging and injection of a contrast agent (dye). This agent is called~     Eovist. It has been marketed since 2004 and used in many countries all over the world.~      The baby will have blood tests before and after the imaging is done to make sure that there~     are no unexpected findings before and after the imaging. Also 3 blood samples up to 8 hours~     after the injection will be obtained in order to measure how much of the dye is in the blood.~     The baby will have an intravenous line which can be used for the blood samples and will not~     need to be stick for the blood samples. Several radiologists will evaluate the images. The~     family doctor will be contacted to find out what was the diagnosis and treatment after the~     results of the MRI were known. Six months after the study, the parent(s)/legal guardian(s)~     will be contacted to make sure the that baby did not have any problems, especially with the~     skin, joints and eyes.~   "
113285|NCT02084615|"~     The purpose of this study is to determine whether aspirin taken in the perioperative period~     will increase the blood loss associated with open inguinal hernia repairs. A secondary~     purpose of this study is to determine if the aspirin administered in the perioperative period~     increases the risk of complications associated with open inguinal hernia repairs.~   "
113286|NCT02084602|"~     There is growing evidence of the emergence of P. falciparum resistance to artesunate (a~     derivative of artemisin) in Southeast Asia. The emergence and spread of resistant strains to~     artemisinin would represent an alarming threat to the success of the antimalarial combination~     therapy in the region. The delayed clearance of parasitemia for more than 24 hours has been~     taken as an early sign of resistance, a phenomenon seen at the Thai-Cambodia border.~      The purpose of this research study, is to assess the in vitro and in vivo efficacy of~     combinated artesunate/mefloquine therapy to treatment of uncomplicated Plasmodium falciparum~     malaria in the Peruvian Amazon through the analysis of the rate of clearance of parasitemia~     and other important outcomes.~   "
113287|NCT02084589|"~     This is a prospective, randomized, double blind study, in which a comparison of patient~     controlled epidural analgesia (PCEA) of continuous background infusion with demand dose and~     demand only, using ropivacaine 0,15% and fentanyl 2μg/ml for pain relief in labor, is being~     investigated. The purpose of the study is the assessment of the efficacy of labor analgesia~     and maternal satisfaction.~      Written informed consent is obtained by all parturients. Non invasive monitor of blood~     pressure, heart rate, SpO2, ECG for the patient and a continuous monitoring of the fetal~     heart rate is being placed.~      The participants are randomized in two groups, both receiving the same drug (ropivacaine~     0,15% and fentanyl 2μg/ml). Group 0 receives demand dose of 5 ml with lockout of 10 minutes.~     Group 1 receives background infusion of 5 ml/h and demand dose of 5 ml with lockout 10~     minutes.~      All parturients have to be instructed to self administration of epidural bolus dose when they~     experience mild to moderate pain. Both parturient and anesthetist who conducts the study and~     treat breakthrough pain, are blind to group assignment.~      After the last suture, total volume of epidural infusions of PCEA, total infused drug of PCEA~     pump, number of delivered PCEA boluses and manual rescue doses are being calculated. Time of~     delivery, mode of delivery, Apgar scores, and overall maternal satisfaction scores, neonate~     pH and Hct of the patient (ABGS), as well as possible need of newborn cardiopulmonary~     resuscitation are also recorded.~   "
113288|NCT02084576|"~     To compare the anti-inflammatory efficacy of ketorolac of tromethamine 0.4% and nepafenac~     0.1% eye drops for prophylaxis of cystoid macular edema (CME) after small-incision cataract~     extraction.~   "
113289|NCT02084563|"~     The objective of this study is to describe the prevalence and prognostic impact of the most~     common genetic abnormalities in patients with Myeloid Neoplasms, including Acute Myeloid~     Leukemia (AML), Myeloproliferative Neoplasms (MPN), Myelodysplastic Syndromes (MDS) and~     Myeloproliferative/Myelodysplastic Neoplasms. Patients will have samples of blood and/or bone~     marrow collected and sent to Hospital Israelita Albert Einstein for analysis and storage.~      Patients with a diagnosis of Acute Myeloid Leukemia will be treated according to an uniform~     protocol.~   "
113290|NCT02084550|"~     The detrimental effects of catabolism, insuline resistance and muscle wasting on surgical~     outcome is wellknown. This catabolism is especially pronounced in patients with acute or~     chronic inflammation (IBD, cancer) and for those undergoing major surgery. Patients with~     ulcerative colitis operated with an ileal pouch-anal anastomosis (j-pouch) fall well into~     both these categories.~      To prevent this undesirable catabolism, we will investigate the effects of intravenous~     administration of predominantly anabolic amino acids (with an amino acid content equal to~     breast milk) on whole body metabolism, with special emphasis on muscle and fat metabolism and~     intracellular signalling pathways.~      Twenty-four patients will be block-randomized by gender in this parallel-group, randomized,~     assessor-blinded, placebo-controlled trial to receive either Vaminolac® (Fresenius Kabi) or~     saline. Metabolism before and after the intervention will be assessed by palmitate- and amino~     acid kinetics of radioactively labelled tracers, while muscle and fat biopsies will be~     analyzed for differences in intracellular signaling pathways (PI3 kinase, Akt, etc.) as a~     measure of cellular activity.~      With this study we hope to find evidence for anabolic effects of intravenous amino acids in~     j-pouch surgery for ulcerative colitis. The perspective is a potential for primary~     prophylaxis of surgical complications, reduction in the length of hospitalization, and~     subsequently optimized long-term functional outcome of the pouch.~   "
113291|NCT02084537|"~     Prospective, randomized controlled trial comparing Endoscopic Ultrasound (EUS) Guided~     cystogastrostomy or cystoduodenostomy and endoscopic necrosectomy to minimally invasive~     surgical necrosectomy, in patients with necrotizing pancreatitis.~   "
113306|NCT02084342|"~     Intraoperative administration of tranexamic acid (TXA,T) reduces significantly blood loss and~     blood transfusion requirements during spinal posterior fusion in adolescents with scoliosis.~     TXA acts mainly by inhibit the plasminogen activator.~      Desmopressin (DDAVP ,D) can inhibit the fibrinolytic activity by inducing the release of von~     Willebrand factor from the endothelial cells. But at the same time, it releases tissue-type~     plasminogen activator (t-PA), which may cripple its hemostatic effect.~      The investigators supposed that if the investigators combine TXA with DDAVP in scoliosis~     correction surgery, the blood loss and the transfusion need would be reduced significantly.~   "
113292|NCT02084524|"~     Malnutrition priori a major abdominal surgery is frequent and increases morbidity and~     mortality. The management of malnutrition has an impact in reducing postoperative~     complications. However malnutrition is rarely detected and Guidelines infrequently followed.~      Recovery time and nutritional evaluation in elderly patients are major criteria in their~     postoperative management. Identifying malnutrition or malnutrition risk is fundamental to its~     treatment. It is therefore unsurprising that many validated tools for nutrition risk~     screening and nutrition assessment exist for the clinician to use in assisting with the~     accurate identification, referral and treatment of patients who are malnourished or at risk~     of malnutrition.~      And nutritional management must be adapted and based on this evaluation and evolution of the~     general status (Guidelines Grade A).~      A geriatric evaluation based on a screening of preoperative malnutrition should allow a~     better implementation of the European Society of Parenteral and Enteral Nutrition (ESPEN)~     guidelines.~   "
113293|NCT02084511|"~     To investigate the effectiveness of BI 1026706 powder for reconstitution of an oral solution~     compared to placebo and the relative effectiveness compared to Celecoxib.~   "
113294|NCT02084498|"~     The investigators hypothesize, that non-optimally treated carbohydrate counting-naïve~     patients with type 1 diabetes can achieve better metabolic control by counting carbohydrates,~     and that the metabolic control can be further improved with concurrent use of Accu-Chek Aviva~     Expert. Additionally, the investigators propose that carbohydrate counting will lead to~     better quality of life as a result of fewer restrictions when eating and less variation in~     blood glucose. Finally the investigators hypothesize that the use of Accu-Chek Aviva Expert~     will lead to fewer hypoglycemic episodes.~   "
113295|NCT02084485|"~     The study was performed to assess the effect of PH-797804 on neutrophils (white cells) in the~     sputum after a challenge with an endotoxin (inhaled LPS). Neutrophils are a sign of~     inflammation and PH-797804 is being developed as a potential anti-inflammatory treatment for~     patients with Chronic Obstructive Pulmonary Disease (COPD).~   "
113296|NCT02084472|"~     Aqueous (EUA) cream, cetomacrogol (CMG) and emulsifying ointment (HEB) are in South Africa's~     essential drug list (EDL) but are not available to most rural patients. To assess whether~     accessible moisturizers can be used as alternatives in atopic eczema (AD), a randomized~     controlled trial of patients with mild-to-moderate AD, aged 1-12 years was conducted. Two~     separate sub-studies were conducted using a randomized controlled single (assessor) blind~     trial design. Study 1 compared UEA vs. liquid paraffin (unscented baby oil) for baths, all~     patients used HEB as moisturiser. In Study 2, 4 moisturisers were compared -HEB, CMG,~     petroleum jelly and petroleum jelly/Glycerine (2:1). Assessments (SCORAD, POEM, NESS and~     IQDOL) carried out at baseline, week 4, 8 and 12. Routine topical steroids and antihistamines~     were continued as prescribed.~   "
113297|NCT02084459|"~     The purpose of this randomized study is to find out whether using the Danish-developed~     nursing intervention guided self-determination (GSD) can improve life skills of the chronic~     pain patient.~      The hypothesis is using guided self-determination in the treatment of chronic pain patients~     will increase the life skills of the patients and thus their life quality in spite of pain.~   "
113298|NCT02084446|"~     This is a 12-month single center, randomized, open-label, single center study designed to~     compare the safety and efficacy of everolimus and very low dose tacrolimus versus~     enteric-coated sodium mycophenolate and low tacrolimus exposure in de novo kidney transplant~     recipients.~      The purpose of this study is to compare safety and efficacy of two immunosuppressive regimens~     based on low tacrolimus exposure combined to everolimus or to enteric-coated mycophenolate~     sodium (EC-MPS) in de novo kidney transplant recipients.~   "
113299|NCT02084433|"~     The purpose is to compare the efficacy of an intraosseous anaesthesia using a computerized~     system (QuickSleeper) to a conventional infiltration anesthesia. Our hypothesis is that~     anesthesia via QuickSleeper system can reduce pain during anesthesia and obtain a more rapid~     local anesthesia compared to the anesthesia via conventional technique by infiltration.~      Design: split-mouth design AND parallel-arm design~   "
113300|NCT02084420|"~     The purpose of this study is to evaluate of efficacy and safety as H.pylori eradiation effect~     between Ilaprazole and Pantoprazole triple therapy for 7 days treatment in Gastric and/or~     Duodenal ulcer patients with H.pylori positive infection.~   "
113301|NCT02084407|"~     The objective of the study is the modelisation of human cardiomyocyts from pluripotent stem~     cells in order to study the cardiac alterations induced by CTG expansions.~   "
113302|NCT02084394|"~     Cardiac surgery is associated with multiple events and issues that increase risk for adverse~     postoperative neurological outcomes including postoperative cognitive dysfunction. The risk~     for postoperative delirium is generally thought to result from some previous health factors~     added to the susceptibility of the cardiac surgery process.~   "
113303|NCT02084381|"~     The medium cut-off dialysis membrane has been developed to provide a significantly extended~     molecular cut-off compared to conventional high-flux membranes. The medium cut-off membrane~     allows for a high permeability of molecules up to a molecular weight of 45 kDa and has a~     still limited permeability for albumin (68 kDa).~      The main goal of this project is the evaluation of the new, highly porous and selective~     dialysis membrane (MCO-Ci 400) for the treatment of patients with end-stage renal disease in~     hemodialysis mode and to study its potential to improve chronic inflammation.~   "
113304|NCT02084368|"~     The research is to study the effectiveness and safety of combined lumbar plexus and sciatic~     nerve block by the guide of peripheral nerve stimulator (PNS) in unilateral knee~     replacement.There have be some papers which supported that combined lumbar plexus and sciatic~     nerve block may be more suitable for the old men.~   "
113305|NCT02084355|"~     Although opioid rotation is well known treatment modality in reducing pain and opioid-induced~     neurotoxicity, it is not established whether opioid rotation is more appropriate or opioid~     escalation is more effective in controlling significant pain in cancer patients under opioid~     medication.~      - The purpose of this study is to determine effective therapy out of opioid rotation and~     opioid dose escalation in patients with moderate to severe cancer pain who have been already~     treated with strong opioid.~   "
113318|NCT02084186|"~     The purpose of this study is to determine whether moxibustion is effective to mild and~     moderate ulcerative colitis and the effect of moxibustion on metabolism.~   "
113307|NCT02084329|"~     After a mild traumatic brain injury (mTBI) people often report balance problems. At Parkwood~     hospital we have noticed that balance is improved when patients with mTBI wear a weighted~     compression vest. This follow up pilot study looks at the immediate effects of weighted~     compression vests on participants with altered balance after mTBI. Participants will be~     recruited from the Ministry of Health Outpatient Acquired Brain Injury (ABI) Program wait~     list. Then each participant will perform a series of balance and walking tests under 2~     conditions : 1) wearing a weighted compression vest , 2) not wearing a weighted compression~     vest. It will be randomized whether participants wear the vest on the first or second testing~     day. Participants will also be asked how confident they are about their balance and how~     anxious they felt performing the assessments after each testing session. We hypothesize that~     the weighted compression vest will improve fatigue and anxiety immediately and 24 hours after~     performing a complex task, and will improve static and dynamic balance, gait variability, and~     walking speed in patients with mTBI, during the tasks.~   "
113308|NCT02084316|"~     This study will evaluate the effects of a comprehensive approach (One4All) to increase the~     percentage of patients that receive their HIV testing results and counseling.~      Primary Hypothesis: The One4All approach will increase the proportion of individuals who have~     completed all tests to confirm HIV diagnosis and received counseling within 30 days of~     screening HIV+, given they have screened HIV+ on the initial test, from 40% to 60%.~   "
113309|NCT02084303|"~     The investigators plan to study inflammation in the brain (neuroinflammation) in human~     patients with epilepsy using a novel, non-invasive technique that has been proven successful~     in humans with other neuroinflammatory diseases. This technique uses ferumoxytol, a drug with~     minimal side effects that is FDA-approved for the treatment of iron deficiency anemia, as the~     contrast agent in magnetic resonance imaging (MRI). The study will recruit epilepsy patients~     who are admitted to Dartmouth-Hitchcock Medical Center (DHMC) for~     video-electroencephalography (video-EEG) monitoring in order to evaluate their candidacy for~     curative brain surgery. During the hospital stay and after informed consent, the patient will~     receive a standard-dose intravenous injection of ferumoxytol, and undergo one session of MRI~     at 24-48 hours after the injection. The patient will also undergo a separate baseline MRI~     session (if not already done at DHMC) at admission or at more than four weeks after the~     injection but before any brain surgery. Brain regions that preferentially uptake ferumoxytol~     are localized by subtracting the post-injection MRI session from the baseline MRI session.~     The investigators will investigate whether these regions overlap with the epileptogenic~     focus, namely the region that generates epilepsy and is localized by video-EEG and other~     diagnostic measures. Lastly, for those patient participants who thereafter undergo brain~     surgery, DHMC neuropathologists will use special stains to detect and quantify~     neuroinflammation in brain tissue removed, and the results will serve as the reference for~     the investigators to measure the sensitivity and specificity of ferumoxytol-based MRI in~     detecting neuroinflammation.~   "
113310|NCT02084290|"~     Specific Aim: Study the impact of the Crohn's Disease Shared Decision Making Program on~     patients' treatment choice, persistence with chosen therapy, decision quality, cost of care,~     and outcomes~      Hypothesis: The Crohn's Disease Shared Decision Making Program will help patients understand~     which treatments are right for them and will lead to a higher acceptance of appropriate~     therapy, improved persistence with chosen therapy, lower costs and improved clinical~     outcomes. To accomplish this aim, Investigators will perform a randomized controlled trial~     to:~        1. Determine how the shared decision making program influences patients' choice of therapy~        2. Evaluate how the shared decision making program affects persistence with chosen therapy~        3. Determine how the shared decision making program affects decision quality~        4. Determine how the shared decision making program influences cost of care and clinical~          outcomes~      Expected Outcome and Impact: Investigators expect that this program will influence patients'~     choice of therapy, persistence with their preferred therapy, and lead to improved clinical~     outcomes. Investigators believe that this product can be successfully operationalized in the~     clinic to establish a new paradigm of how providers can communicate personalized treatment~     options to patients across a broad range of diseases.~   "
113311|NCT02084277|"~     The objective of this prospective study is to compare these two treatments (conventional~     brackets v.s. self-ligating brackets) in malocclusion to determine which treatment will~     provide the better oral health related quality of life (OHRQoL) outcomes for patients during~     the initial orthodontic treatment compared with pretreatment.~   "
113312|NCT02084264|"~     To compare the accuracy and feasibility, curvature correction and clinical outcomes of~     pedicle screw instrumentation with versus without robotic guidance, in pediatric and~     adolescent scoliosis patients~   "
113313|NCT02084251|"~     GLP-1 analogues have been widely used because of their unique advantages (no risk of~     hypoglycemia) due to their glucose dependent mechanism. Due to the short half-life of peptide~     in plasma, peptides have to be administered frequently (i.e. BID for Byetta, with Exenatide~     as API).To improve the patients compliance and reduce potential adverse events associated~     with GLP-1 analogues, a long acting GLP-1 analogue (PB-119), which may be administered once~     weekly, was developed by PegBio Inc. In order to provide rational for dosage range to be~     studied in Phase Ib, the safety profile, tolerance, and pharmacokinetic behavior of PB-119 in~     healthy subjects will be studied in this randomized, controlled dose escalating trial.~   "
113314|NCT02084238|"~     This clinical study will test the efficacy and safety of low dose IL-2 treatment in Systemic~     lupus erythematosus.~   "
113315|NCT02084225|"~     The purpose of this study is to determine feasibility, perceived utility and sustainability~     of training local providers in ultrasound guided regional anesthesia for acute pain~     management in a limited-resource conflict setting.~   "
113316|NCT02084212|"~     The aim of this research is to assess current care by studying macular function using~     microperimetry and by then comparing visual acuity results with OCT (Optical Coherence~     Tomography) data.~      The examinations performed are those usually done in the follow-up of epiretinal membrane~     surgery, apart from microperimetry which is an examination of the central visual field.~     Patients who undergo ERM surgery usually have a follow-up examination at 1 month, 3 months~     and 6 months after the surgery. The consultation includes an assessment of visual acuity, a~     fundus examination an SD-OCT of the retina. The present protocol will require no additional~     visits. The microperimetry will be done in addition to the usual follow-up examinations after~     ERM surgery.~   "
113319|NCT02084173|"~     With the aging of western societies in the coming years combined with increasing alcohol~     consumption among elderly, the number of elderly with alcohol problems is expected to rise~     considerably.~      Elderly patients are often lonely; suffer from feelings of loss, fear to be a burden on their~     children and on society, and feel powerless. On the surface their alcohol related problems~     seem less severe that those of the middle-aged patients while in reality co-morbidity and~     social issues complicate alcohol dependency.~      Currently, no specific treatment tailored for alcohol use disorder among elderly is~     available. Consequently they receive either no treatment, are given brief advising from the~     general practitioner or are referred to treatment at specialized treatment institutions with~     no specific treatment for elderly.~      The investigators propose a study aimed at developing and testing an outpatient behavior~     therapy program for alcohol use disorders for seniors (60 years and older), which - if~     effective - can be easily implemented in routine care. Three centers from Denmark, Germany~     and USA (New Mexico) will participate. All three centers have a long and extensive experience~     with alcohol treatment and alcohol research. Patients fulfilling the DSM 5 criteria for~     alcohol use disorder are eligible for the study.~      After informed consent participants will be randomly assigned to either Motivational~     Enhancement Therapy (MET), four sessions/one session per week or MET followed by Community~     Re-enforcement Approach (CRA), eight sessions/one session per week - thus 12 weeks of~     treatment in total. 50% will receive MET and 50% MET+CRA. Primary outcome is percentage of~     patients with abstinence or controlled use (alcohol intake of equivalent blood alcohol~     content equal to or less than 0.5‰.). A total of 1000 patients will be enrolled. Participants~     will be assessed with a battery of international validated instruments measuring drinking~     pattern as well as key elements of treatment.~      Participants are assessed before initiation of treatment, at the end of MET treatment (four~     weeks), at the end of MET+CRA treatment (12 weeks), at 6 months, and at 12 months.~   "
113320|NCT02084160|"~     The objectives of this study are:~        -  To evaluate the ability of the Methacetin Breath Test (MBT) to detect hepatic~          decompensation events~        -  To evaluate the relationship between liver Biopsy and clinical outcome and show that the~          MBT has a better predictive ability of clinical outcome than liver biopsy.~        -  To evaluate the ability of the MBT to predict each of the individual liver related~          complications.~   "
113321|NCT02084147|"~     This randomized pilot clinical trial studies how well positron emission tomography~     (PET)-magnetic resonance imaging (MRI) works compared to standard-of-care PET-computed~     tomography (CT) in diagnosing patients with cancer, cardiac diseases, or neurologic diseases.~     PET-MRI combines two imaging methods that can be used to evaluate disease. PET-MRI is similar~     to standard-of-care PET-CT, but exposes the patient to less radiation. It is not yet known~     whether PET-MRI produces better image quality than PET-CT in diagnosing patients with cancer,~     cardiac disease, or neurologic disease.~   "
113322|NCT02084134|"~     During transsphenoidal resection of pituitary tumors and cysts, surgery is performed by a~     neurosurgeon and ear nose and throat surgeon. The pituitary tumor or cyst is reached by~     making a small hole in the back of the nose into the bottom of the skull. The surgeon is able~     to see the pituitary and tumor with an endoscope and remove the tumor through the hole.~      Surgery on the pituitary can cause disruption in the secretion of ACTH and cause adrenal~     failure (lack of cortisol secretion) which can cause nausea, vomiting, low blood pressure,~     and rarely can be fatal. There is no consensus among endocrinologists and neurosurgeons about~     the use of perioperative steroids in pituitary patients. Traditionally, all patients~     undergoing pituitary surgery were given steroids before, during, and after surgery because of~     the assumption that there would be some compromise in the amount of ACTH released by the~     pituitary as a result of surgical trauma. Studies have failed to show, however, that ACTH~     secretion is in fact compromised during transsphenoidal pituitary microsurgery. As a result,~     there are some centers that routinely give perioperative steroids to all patients undergoing~     pituitary surgery and there are some centers that do not routinely give perioperative~     steroids. There are several retrospective and prospective studies that have addressed this~     issue and have shown that withholding perioperative steroids is safe, but there has never~     been a prospective study comparing the two approaches.~      Objectives: The goal of this study is to prospectively compare two approaches to the~     perioperative management of patients undergoing transsphenoidal resection of a pituitary~     tumor or cyst. One protocol includes the routine use of perioperative steroids and the other~     does not. The investigators hypothesis, based on previous studies, is that patients who are~     adrenally sufficient do not routinely need to be treated with perioperative steroids. The~     investigators also hypothesize that the use of perioperative steroids may be associated with~     a higher rate of adverse outcomes~   "
113323|NCT02084121|"~     A subject was treated under compassionate use provisions under this study with facilitating~     cell therapy (FCRx) product manufactured using the CliniMACS (Miltenyi Biotec) device, rather~     than the Max Sep (Baxter) device.~   "
113324|NCT02084108|"~     Introduction: Care of frail and dependent elders with multiple chronic conditions is a major~     challenge for health care systems. The objective of this study is to evaluate the effect of~     coordinating the existing structures in the private and public sector for the care of frail~     and dependent persons over age 60, and susceptible of presenting complex bio-psycho-social~     issues. This approach is aimed at improving the coordination, continuity, quality and~     efficacy of care in this population, which presents a high risk of hospitalization, emergency~     room visits, institutionalization and mortality.~      Methods: Three-year cluster randomised controlled trial. A control group receiving usual care~     (follow up by primary care physician and home nursing service) will be compared to an~     intervention group that will be provided, in addition, in-home multidimensional geriatric~     assessment with access to a 24h/7 day a week call service, and coordinated long-term~     follow-up. Survival analyses will be conducted to compare the outcomes between groups.~      Primary outcome:~      - Hospitalizations: rates of first hospitalization, number, cause and length of stay.~      Secondary outcomes:~        -  Emergency room visits: rates of first visit, number and cause~        -  Institutionalization: number of patients~        -  Mortality: rate and number of deaths and place of death (home versus hospital)~   "
113325|NCT02084095|"~     Background Glucose metabolism abnormalities are frequent in acromegaly. Insulin resistance~     (IR) correlates with the intensity of acromegaly and Insulin-like Growth factor-I (IGF-I)~     correlates better with IR than growth hormone (GH). Insulin secretion (IS) is significantly~     reduced in hyperglycemic acromegalics as compared with those with normal glucose levels. IS~     is independent of acromegaly intensity.~      The aim of this study is to show that in active acromegaly: 1) IGF-I does not cause IR but is~     just a better marker of acromegaly intensity than GH; 2) high GH levels induce IR through~     free fatty acids (FFA); 3) hyperglycemia is caused by a defficient IS on a background of IR.~      Methods Intensity of acromegaly will be assessed using serum levels of GH, IGF-I and IGF~     binding globulin-3. IR and IS will be assessd using an intravenous glucose tolerance test~     acording to Bergman model. FFA will be directly measured in plasma.~   "
113326|NCT02084082|"~     The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose~     combination (FDC) tablet containing linagliptin and metformin extended release compared to~     the free combination of linagliptin and metformin extended release, both under fed and fasted~     conditions.~   "
113327|NCT02084069|"~     The purpose of the investigation is to determine whether Atrovastatin as anti-inflammatory~     agent can be effective in preventing from atrial fibrillation incidence in patients whom~     undergone open cardiac surgery for their heart valve repair.~   "
113328|NCT02084056|"~     The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose~     combination (FDC) tablet containing linagliptin and metformin extended release compared to~     the free combination of linagliptin and metformin extended release.~   "
113331|NCT02084017|"~     The purpose of this study is to investigate the current standard of wound care following~     vascular operations compared to to a negative pressure wound therapy (vacuum dressing) and~     the rate of surgical site infections (SSIs) in patients undergoing surgery to restore blood~     flow to the lower limb(s).~      Negative pressure wound therapy consists of a closed, sealed system that produces negative~     pressure (vacuum) to the wound surface. The device itself consists of open-cell foam that is~     sealed with an occlusive adhesive dressing (covers and sticks to the incision) and suction is~     maintained by connecting suction tubes to a vacuum pump and waste collector.~      The investigators objectives are to determine whether there will be any reduction in surgical~     site infection and this potential reduction will influence length of hospital stay, emergency~     room visits, antibiotic use and need for re-operation.~   "
113332|NCT02084004|"~     The aim of this study is to assess the beneficial effects of Bifidobacterium Hydrochloride~     and Berberine on lowering glucose in patients with type 2 diabetes mellitus and to detect the~     potential mechanism.~   "
113333|NCT02083991|"~     Balancing immunosuppressive treatment in organ transplantation in order to achieve effective~     prevention of rejection on one side and avoidance of negative side effects on the other side~     is a major challenge, leading to developing different immunosuppressive protocols.~     Cornerstones of immunosuppressive treatment such as Corticosteroids (CS) and Calcineurin~     Inhibitors (CNI) are known to cause an increased incidence of diabetes, cardiovascular~     morbidity, nephrotoxicity and malignancies.~      The investigators believe that both avoidance of CS and minimization of CNI, while using~     Anti-ThymocyteGlobuline(ATG) induction (instead of interleucin-2 receptor blockers) and~     mycofenolate mofetil(MMF) therapeutic drug monitoring is going to reduce negative side~     effects, without increased rejection frequency in renal transplanted patients.~   "
113334|NCT02083978|"~     In this proposal, the investigators will focus on subcortical gray and white matter~     structures commonly found to be abnormal in schizophrenia. Thus, the investigators will~     evaluate the volume and shape of the hippocampus, thalamus and basal ganglia, as well as~     measures of structural integrity of the corpus callosum and its various subregions.~   "
113335|NCT02083965|"~     The primary objective of the study is to characterize the pharmacokinetics (PK) of rFVIIIFc~     administered at vial strengths of 1000 and 3000 IU in subjects with severe hemophilia A. The~     secondary objective of the study is to evaluate the safety of rFVIIIFc beyond the PK~     assessment for up to 6 months for a continued treatment period.~   "
113336|NCT02083952|"~     Gastroesophageal reflux disease (GERD) has been reported in up to 85% of all infants born~     prematurely, and has been associated with a wide range of symptoms. These include~     irritability, pauses in breathing, heart rate drops, declines in oxygen levels, chronic lung~     disease, and delays in growth and development. A novel approach to the mangement of GERD in~     infants is the use of an abdominal band, applying gentle pressure and possibly reducing the~     reflux of acid from the stomach. The purpose of this study is to evaluate the impact of a~     swaddle blanket with an abdominal band insert on the incidence of infant apnea, bradycardia,~     oxygen declines, and pH (acid) changes.~   "
113337|NCT02083939|"~     The purpose of this study is to find out whether it is necessary to prophylactically treat~     patients undergoing laparoscopic inguinal hernia repairs with antibiotics. Our hypothesis is~     that it is not necessary to pretreat patients with antibiotics if the operation is minimally~     invasive with a mesh placed at the defect.~   "
113338|NCT02083926|"~     -  Social Anxiety Disorder (SAD) is common and causes significant impairment.~        -  First-line treatments for Social Anxiety Disorder are only partially effective. Many SAD~          patients experience little or inadequate symptom relief with available treatments.~        -  Ketamine is a potent NMDA receptor antagonist. Ketamine represents an agent with a~          potentially novel mechanism of action for the treatment of anxiety disorders.~        -  Ketamine has demonstrated efficacy in the treatment of psychiatric disorders closely~          related to Social Anxiety Disorder including Major Depression, Bipolar Depression and~          possibly Obsessive-Compulsive Disorder.~      Ketamine represents the possibility to provide rapid symptom relief to patients with SAD and~     may provide the mechanism for future drug development to treat SAD more rapidly and~     effectively.~   "
113339|NCT02083913|"~     The aim of our study is to evaluate the feasibility of a supervised training session using~     telehealth in the Clinique medico-chirurgicale du traitement de l'obésité de Sherbrooke~     (CMCTO) and its impact on health, physical fitness, quality of life and satisfaction of~     subjects. 6 subjects awaiting bariatric surgery will be recruited. In addition to usual care,~     subjects will perform additional sessions of supervised endurance and resistance exercise~     training. Subjects will be instructed to perform two supervised exercise sessions per week~     with telehealth plus one without supervision during 12 weeks. The following outcomes will be~     assessed before and after the telePreSET, then 12 months after bariatric surgery: 1- physical~     fitness (6MWT, maximal strength, symptom-limited cardiac exercise test); 2-health related~     quality of life (Laval questionnaire); 3-weight, height, body composition (bioelectrical~     impedance scale); 4-comorbidities and metabolic parameters (files and blood samples);~     5-exercise beliefs (Physical Exercise Belief questionnaire); 6-physical activity~     (GPAQuestionnaire and actimeter). The feasibility will be assessed with a satisfaction~     questionnaire concerning physical activity management, dropout and compliance rates, as well~     as the number of injuries and accidents. The results of this research will give us~     preliminary data for future projects in order to improve support of bariatric surgery~     candidates to assure optimal results for their health. Also, we will contribute to the~     advancement of scientific knowledge, absent in the current literature in this population.~   "
113340|NCT02083900|"~     Prospective Randomized double-blind controlled trial comparing the healing rate, infection~     rate, pain score, ease of care and scar formation of Banana leaf dressing versus hydrocolloid~     dressing.~   "
113341|NCT02083887|"~     Two vaccines, ChAd63 ME-TRAP and MVA ME-TRAP, are being tested to see if they will form a~     safe and effective vaccination strategy against malaria. The vaccines have been found to be~     well tolerated when tested in Gambian adults, young children and infants, who are at risk of~     severe malaria. Both vaccines will be given to participating infants at the same time as some~     EPI (Expanded Program on Immunization) vaccines, and assess whether they are safe and still~     helpful in making the body's defense system respond.~   "
113343|NCT02083861|"~     The purpose of this study is to measure the effectiveness of a wearable therapeutic~     ultrasound device in patients with stage I and stage II knee osteoarthritis. The ability of~     the device to reduce pain, increase mobility, increase range of motion and muscle strength of~     the affected leg, and improve quality of life in patients with knee osteoarthritis will be~     evaluated.~   "
113344|NCT02083848|"~     Background of the study: The accurate assessment of local cervical cancer spread (i.e.~     invasion) is of clinical importance for staging and treatment considerations. For example, if~     parametrial invasion is absent, radical surgery is the treatment of choice for tumors less~     than 4cm in diameter. However, if such invasion is present, the patient has become inoperable~     and (chemo)radiotherapy is warranted. Unfortunately, regular 1.5T MRI as a part of staging~     work-up has a limited accuracy for detecting loco-regional tumor invasion. Due to relatively~     frequent false-negative findings a risk of understaging and under-treatment occurs. For such~     cases adjuvant treatments with (chemo)radiotherapy are indicated after the initial surgery,~     causing increased morbidity and treatment associated risks. For higher stages, with primary~     (chemo)radiotherapy, a more reliable MRI based delineation of local tumor spread could enable~     individualized dose(volume) and field modifications.~      Hypothesis/aim of the study: To develop and in vivo optimize T2w ultra high field (7T) MRI~     sequences, which use a combination of an endorectal and external coil, to image the~     (para)cervical area for assessment of the loco-regional tumor status in cervical cancer.~      Study design: The proposed study is an investigator initiated, single center, prospective~     pilotstudy.~      Study population: 20 patients with histological proven cervical cancer stage IB1, IB2, IIA of~     IIB will be included.~      Primary study parameters/outcome of the study: Optimized T2w ultra high field (7T) MRI~     sequences of the (para)cervical area which allow qualitative assessment of the loco-regional~     invasion of cervical cancer.~   "
113345|NCT02083835|"~     PAIN OUT is a multi-national, non-interventional registry and benchmark project, assessing~     and analysing clinical and patient-reported outcome data of postoperative pain.~   "
113346|NCT02083822|"~     The survival of premature babies increased during the last decades. However, the~     neurocognitive long term development of these children is worrying, as demonstrated by~     EPIPAGE 1 study.~      These children present high risk of deficits such as cognitive deficits, adaptive~     malfunction, behavior disorders and difficulties in school learning.~      Understanding the specific neuropsychological disorders at the origin of these deficits is an~     important objective. Studies realized at school age showed that many premature children have~     executive functions (EF) disorders. However the specific nature of these disorders and the~     neuropathology associated are unknown.~      The aim of this study is to realise MRI at term age in preterm babies born less than 32 GA~     and to correlate MRI findings with executives functions and neurodevelopmental outcome~   "
113347|NCT02083809|"~     Currently, there is very little research to identify ways to decrease blood loss during D&E~     (dilation and evacuation) procedures. The objective is to determine whether routine use of~     intravenous oxytocin will improve bleeding outcomes at the time of D&E at 18-24-weeks~     gestation. To evaluate the hypothesis, investigators will perform a randomized,~     double-blinded, placebo-controlled trial. The patient will be followed until discharged from~     the postoperative care unit during which time patient satisfaction, pain score and~     postoperative bleeding will be assessed.~   "
113348|NCT02083796|"~     The hypothesis of this study is that thoracic spine manipulation would reduce pain in~     subjects with SIS and cause changes in scapular kinematics and muscle activity in subjects~     with impingement symptoms and in asymptomatic subjects. With this study, the investigators~     want to answer if possible changes in scapular motion and muscle activity following a TSM~     depend on the symptoms or if it is generic to individuals without shoulder dysfunction and~     not specific to subjects with shoulder impingement.~   "
113349|NCT02083783|"~     The purpose of this study is to determine whether TRI102 is effective in the treatment of~     Attention Deficit Hyperactivity Disorder (ADHD) in children ages 6-12.~   "
113350|NCT02083770|"~     Hispanic Americans are underrepresented in cancer clinical trials. The purpose of this study~     is to develop and test programs designed to reduce barriers and increase facilitators~     associated with cancer clinical trials participation for Hispanic Americans.~   "
113351|NCT02083757|"~     Our goal was to study the feasibility of predicting fluid responsiveness by transcutaneous~     partial pressure of oxygen (PtcO2) in the critically ill patients.~   "
113352|NCT02083744|"~     The long-term goal of this research is to determine whether a psychoeducational intervention~     will support self-care behaviors in Hispanic patients with heart failure. The specific goal~     of this study is to determine whether a culturally-appropriate psychoeducational intervention~     in Hispanic patients with heart failure, compared to a control group, will improve heart~     failure knowledge and self-care behaviors.~      We hypothesize that patients who receive the intervention will have improved heart failure~     self-care behaviors and depression scores as measured by the Self-Care Heart Failure Index~     and Patient Health Questionnaire.~   "
113353|NCT02083731|"~     The purpose of this study is to evaluate the efficacy of mesenchymal stem cells (MSC) in the~     treatment of refractory cytomegalovirus (CMV) infection after allogeneic hematopoietic stem~     cell transplantation (allo-HSCT).~   "
113354|NCT02083718|"~     The purpose of this study is to evaluate the utility of treating patients experiencing poor~     graft function after allogeneic hematopoietic stem cell transplantation with Granulocyte~     Colony-Stimulating Factor (G-CSF) mobilized peripheral stem cell combined (PBSC) with~     ex-vivo-expanded BM-drived mesenchymal stem cells from third-party donors. Our first~     objective was to evaluate the effect of such treatment on poor graft function, and second~     object was to investigate the safety of such treatment.~   "
113355|NCT02083705|"~     Guidelines on neonatal resuscitation recommend 90 chest compressions (CC) and 30 manual~     inflations (3:1) per minute in newborns. The study aimed to determine if CC s during~     sustained inflations (SI) improves recovery of asphyxiated newborns compared to coordinated~     3:1 resuscitation.~   "
113356|NCT02083692|"~     The purpose of this study is to assess the effect of metformin in tumor metabolism in~     patients with head and neck cancer by evaluating metformin's ability to decrease TOMM20~     expression in squamous carcinoma cells and decrease MCT4 expression in fibroblasts.~   "
128421|NCT01886469|"~     The main purpose of this study is to determine the rate and extent of absorption of one or~     more modified release formulations of amphetamine (HLD100) in both adolescents and children~     with ADHD.~   "
113357|NCT02083679|"~     This is a multi-center, open-label, Phase 1b, dose escalation trial of Sym004 administered in~     combination with 1 of 3 platinum-doublets in subjects with Stage IV Non-Small Cell Lung~     Cancer (NSCLC).~      The sponsor decided to discontinue the development of Sym004. Also the decision was made to~     discontinue the development of Sym004 in NSCLC indication. The decision to discontinue Sym004~     in NSCLC was not related to any safety or efficacy findings regarding Sym004. As a result of~     the early discontinuation of the trial during the dose escalation part, the expansion cohort~     will no longer be performed hence the pre-specified secondary endpoints are not analyzed and~     were removed from the protocol based on protocol amendment 2 dated 31 March 2015.~   "
113358|NCT02083666|"~     The main purpose of this study is to assess the safety and tolerability of SOBI002 in healthy~     volunteers following single and repeated administration.~   "
113359|NCT02083653|"~     This is a Phase 2, open-label, 3-arm trial of two Sym004 doses (Arms A and B) and a control~     group (Arm C) in subjects with metastatic colorectal cancer (mCRC) and acquired resistance to~     anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (mAbs).~   "
113360|NCT02083640|"~     This study is to assess the relative bioavailability of palbociclib hard gelatin capsule~     formulation (API 41 micrometer and dissolution Level 1) and palbociclib hard gelatin capsule~     formulation (API 16 micrometer and dissolution Level 2) compared to the palbociclib hard~     gelatin capsule formulation (API 16 micrometer and dissolution Level 1) after single 125 mg~     oral doses under fed conditions in healthy volunteers.~   "
113361|NCT02083627|"~     This study will assess the effect of multiple doses of fidaxomicin on the single dose~     pharmacokinetics of rosuvastatin in healthy male subjects. Determine the safety and~     tolerability of multiple doses of fidaxomicin in the presence of a single dose of~     rosuvastatin in healthy male subjects. Also determine the pharmacokinetics of multiple doses~     of fidaxomicin and its metabolite OP-1118.~   "
113362|NCT02083614|"~     The effect of clamping the indwelling urethral catheter before removal is an unsettled issue~     in clinical practice. No studies have done before in the patients with gynecologic cancers~     who received radical hysterectomy. We hypothesized that clamping the catheter would decrease~     the rate of recatheterization. In addition, the feeling of urination during clamping is~     correlated with lower rate of recatheterization after removal.~   "
113363|NCT02083601|"~     The current study will implement and evaluate a multi-component, psychoeducational~     intervention for caregivers of children with spinal cord injury (SCI) ages 7-12. Two~     hypotheses will be tested. First, caregivers who participate in the intervention group will~     demonstrate better outcomes than caregivers in the control group. Second, children with SCI~     whose caregivers participate in the intervention group will demonstrate better outcomes than~     children with SCI whose caregivers participate in the control group.~   "
113364|NCT02083588|"~     Fibromyalgia Syndrome (FMS) is a highly prevalent condition often affecting individuals in~     the prime of life, causing severe reduction in quality of life and productivity, as well as~     social isolation, anxiety, and depression. The purpose of this study is to explore the~     efficacy of H1 deep TMS for the treatment of FMS patients. In addition, the investigators~     attempt to assess the effect of dTMS on the perception and modulation of pain in patients~     suffering from FMS.~   "
113365|NCT02083575|"~     role of Vit C to Augment iron chelation with DFP or DFX in thalassemic patients.~   "
113366|NCT02083562|"~     The purpose of this study is to assess the association of biomarkers on day 7 of life with~     the development of bronchopulmonary dysplasia in very preterm infants. Additionally a short~     lung function test at 36 weeks postmenstrual age (PMA) will be performed to investigate~     whether certain capnographic indices are able to reflect the degree of lung disease.~      Protocol was amended (under others: additional enrollment of 70 subjects).~   "
113367|NCT02083549|"~     The purpose of the study is to evaluate the efficacy of the University of Rochester Medical~     Center's current Massive Transfusion Protocol.~      Upon arrival of trauma level one designated patients the treating team evaluates the~     patient's injuries. If the patient is initiated under the facilities Massive Transfusion~     Protocol and meets other inclusion and exclusion criteria the patient will be enrolled in the~     study. Study procedures include collection of a blood sample following the transfusion of~     each shipment, through shipment 5, of blood products outlined in the current Massive~     Transfusion Protocol.~      Each blood sample will be run on a Thromboelastograph to evaluate the patient's hematostatic~     state through resuscitation. One final blood sample will be collected 24 hours following the~     discontinuation of the Massive Transfusion Protocol and also ran on the thromboelastograph.~      Due to the critical need for medical intervention, consent procedure will be waived at time~     of enrollment. An authorized representative for the patient will be identified and approached~     to obtain consent for use of data collected.~   "
113368|NCT02083536|"~     The ultimate clinical aim of this proposed phase I trial is to evaluate the toxicity and~     determine the recommended phase II dose of combining the effect of LDFWART following~     administration of docetaxel for 6 cycles in patients with recurrent platinum-resistant~     ovarian cancer.~   "
113369|NCT02083523|"~     This study will use a pilot test format to examine the efficacy of a brief Motivational~     Interviewing (MI) intervention developed by the investigator Dr. Douglas Smith called CHOICE~     (Compassionate Helpers Openly Inviting Client Empowerment)with youth referred for substance~     abuse assessments to substance abuse treatment agencies in Chicago and Urbana, IL.~   "
113370|NCT02083510|"~     The aim of this trial will be to determine an effect-size for the administration of chronic~     low-dose colchicine in the reduction of serum levels of triglycerides (TG), very-low density~     lipoproteins (VLDL), and apolipoprotein CIII (apoCIII) in human subjects over a period of 4-6~     weeks.~   "
113371|NCT02083497|"~     To evaluate the influence of different types of ankle taping in dynamic equilibrium and the~     electrical activity of the support member during the sporting gesture kicking muscles.~   "
113430|NCT02082704|"~     Investigators are conducting a randomized controlled trial to determine whether an online~     team-based spaced education (SE) game can improve HbA1c levels among these patients with~     diabetes (primary aim). Secondary aims include determining the impact of the game on~     patients' pill possession ratio (PPR) of oral DM meds and their microalbumin/creatinine (M/C)~     ratio, ACE PPR, and ARB PPR.~   "
129080|NCT01877850|"~     The purpose of this study is to evaluate the difference of the duration of weaning process~     from the ventilator between protocol-driven weaned patients and clinical judgment driven~     weaned patients.~   "
113372|NCT02083484|"~     This is an expanded access program (EAP) for participants who have progressed after prior~     systemic therapy including ipilimumab, and V-raf murine sarcoma viral oncogene homolog B1~     (BRAF) inhibitor or mitogen-activated protein kinase (MEK) enzyme inhibitor when indicated.~     Participants cannot be eligible for or have participated in any pembrolizumab (MK-3475)~     clinical trial with the exception of a participant enrolled in the pembrolizumab protocol~     MK-3475-006 who received treatment on the ipilimumab treatment arm and progressed; such~     participants will be eligible to participate in the EAP, regardless of prior treatment with a~     BRAF/MEK inhibitor, as long as all other eligibility criteria for MK-3475-030 are met.~   "
113373|NCT02083471|"~     Egg, milk and cereal allergies are the most important food allergies in Finnish children, the~     prevalence in western countries is 1-4 %. In some individuals food-allergy is maintained in~     to adulthood. Recent studies suggest that specific oral tolerance induction (SOTI) provides a~     treatment option in children with continuing allergy with high success rates. The study aims~     at specific oral tolerance induction in adults allergic to cow's milk or hen's egg. Oral~     immunotherapy involves taking very small amounts of the allergen, and slowly increasing the~     amount. Consequently, an elimination diet may be wholly or partially cancelled, without the~     fear of serious allergic reactions. Another aim is to explore changes in antibody-mediated~     and cell-mediated immune response to individual components of cow's milk and egg allergens~     during tolerance induction and compare these with the effect of the treatment.~   "
113374|NCT02083458|"~     The central line placement is the widespread procedure performed in the intensive care and~     emergency medicine. Indications for this procedure are chiefly lack of peripheral catheters,~     administration some medications, renal replacement therapy, parenteral nutrition and~     hemodynamic monitoring.~      The procedure is performed by percutaneous puncture of large vein of the neck and the thorax~     - internal jugular vein or subclavian vein, then insertion of guidewire through the needle~     and placement of the catheter over the guidewire. The tip of the catheter is situated in the~     superior vena cava.~      There are two techniques of catheterizations: landmark-based and ultrasound-guided. The most~     frequently cannulated veins in landmark-based approach are internal jugular and subclavian~     vein. The cannulation of the axillary vein is not common procedure in the intensive care~     unit, mainly due its complicated original technique.~      The primary intention of this study was to describe and assess usefulness and safety of the~     new landmark-based technique of catheterization of the axillary vein in patients admitted to~     the intensive care unit.~   "
113375|NCT02083445|"~     Circulating progenitor cells (CPC) treatments may have great potential for the recovery of~     neurons and brain function. Our group has reported how exposure to intermittent hypobaric~     hypoxia with superficial muscle electrostimulation is able to increase the concentration of~     CPC in peripheral blood in humans. Therefore, we believe that through physical activities and~     exposure to intermittent hypobaric hypoxia for a period, it will increase CPC in the blood of~     subjects who have suffered a severe Traumatic Brain Injury (TBI) one or more years ago,~     promoting regeneration and functional and cognitive recovery. The study primary end-point is~     to improve physical or psychological functioning of participants with TBI with a program of~     exercise, muscle electro-stimulation (ME) and/or intermittent-hypobaric-hypoxia (IHH).~     Secondary end-points are to increase and maintain CPC and also to study their possible~     relationship with physical or psychological improvement of participants with Traumatic Brain~     Injury (TBI). In order to achieve these objectives investigators have designed a randomized~     controlled trial that will include those patients who suffered severe TBI more than one year~     previously with physical or psychological sequelae. Exercise, muscle electro-stimulation (ME)~     and/or intermittent hypobaric hypoxia (IHH) programs will be applied during twelve weeks.~     Psychological and physical stress tests will carry out before and after the program and CPC~     will measure at the beginning, every two weeks, and at the end of the program.~   "
113376|NCT02083432|"~     The aims of the study: to explore the possible effectiveness of cognitive behavior treatment~     (CBT) among children and adolescents with formally diagnosed intra-oral injection phobia~     (DSM-IV), when performed by specially trained dentists.~      The patients diagnosed with intra-oral injection phobia according to the diagnostic manual~     DSM-IV. The effect of cognitive behavior therapy when performed by specially trained dentists~     will be evaluated. Patients referred to the Centre for Odontophobia, and who meet the~     inclusion criteria, will be allocated to an immediate treatment group (test group) and a~     waiting list group (control group) of 30 subjects in each group. After treatment they will be~     followed up during a 1-year period.~      Hypotheses are formulated based on the literature and previous population and treatment~     studies of similar designs among adults at the Centre for Odontophobia.~   "
113377|NCT02083419|"~     Cardiac resynchronization therapy (CRT) or biventricular pacing is a useful treatment for~     heart failure and those suffering from arrhythmias. The purpose of this research study is to~     determine the effect left-ventricular pacing has on patients who have a ventricular assist~     device.~   "
113378|NCT02083406|"~     A single dose study to investigate how different formulations of OZ439 co-administered with~     PQP tablest are processed by the body when taken without food~   "
113379|NCT02083393|"~     To observe changes of circulating and tissue dendritic cells in acute lung injury,including~     invasive aspergillosis pneumonia~   "
113380|NCT02083380|"~     A randomised, double-blind single-dose study to determine the efficacy, safety, tolerability~     and pharmacokinetics of OZ439 (artefenomel) in combination with piperaquine (PQP) in patients~     > 0.5 years and <= 70 years of age with uncomplicated Plasmodium falciparum malaria in Africa~     and Asia (Vietnam).~      Interim analyses for futility were planned. Adults and children will be included through~     progressive step-down in age following safety review by an independent safety monitoring~     board (ISMB).~      If the study were to meets its efficacy objectives, this will inform dose setting for Phase~     III studies.~   "
113381|NCT02083367|"~     Investigating the impact of hepatic encephalopathy on default mode networks within the brain~     to provide more clues with understanding the physiology of consciousness and predicting the~     reversibility of comatose states.~   "
113431|NCT02082691|"~     Patient with advanced liver cancer (cancer that has spread to other parts of the body)~     continues to receive the study drug (G-202) even though patient no longer meets the criteria~     to be a part of the main treatment study. Patient's cancer responded well to receiving G-202~     in the main study and will receive G-202 at the same dose given in the main study.~   "
113382|NCT02083354|"~     This is a single-arm, open-label, multi-center, Phase II study to evaluate dabrafenib and~     trametinib combination therapy in subjects with BRAF V600 mutation-positive, unresectable or~     metastatic Acral lentiginous or cutaneous melanoma. This study will evaluate the objective~     response rate (ORR), progression free survival (PFS), duration of response, overall survival~     (OS), safety and efficacy, to assess steady state (all subjects) exposure to dabrafenib,~     dabrafenib metabolites, and trametinib and characterize the population pharmacokinetics (PK)~     and pharmacodynamics (PD) of dabrafenib and trametinib. Subjects will be enrolled and will~     receive dabrafenib 150 milligram (mg) orally twice daily and trametinib 2 mg orally once~     daily. Treatment will continue until disease progression, death, unacceptable toxicity, or~     withdrawal of consent, or study closure. After treatment discontinuation, subjects will be~     followed for survival and disease progression as applicable.~   "
113383|NCT02083341|"~     Muscle tension dysphonia (MTD) is a disabling voice disorder which causes severe voice~     change, neck pain, and voice fatigue. Current therapy modalities to treat these disorders~     include multiple visits to a qualified speech language pathologist (SLP) for rehabilitation~     with voice exercises and focused laryngeal/neck massage. Access to these services is~     difficult with long waitlists and often not covered by current public health insurance or~     locally available to many patients in Ontario. The goal of this study is to demonstrate a~     reduction in symptoms and improvement in vocal function by applying an external vibration~     device to key sites (e.g. jaw, neck, skull base) commonly identified as a source of abnormal~     muscle tension and injury in certain voice disorders, specifically MTD.~      This study will also investigate the effect of external vibration on the voice quality in~     classically trained singers (CTSs). Certain desirable acoustic qualities in a singers' voice~     are only accessible when the larynx and its extrinsic muscles are in a relaxed state. Muscle~     misuse and vocal strain are common problems in performers, which can result in conditions~     that require surgery and speech therapy, and may lead to a loss of income. Similar to vocal~     warm up exercises which contribute to the prevention of vocal injury, external vibration is~     expected to improve muscle perfusion in an acute setting and may have a direct effect on~     vocal fold cover viscosity.~      Both study groups will be randomized to receive either the external vibration device or a~     sham device. The sham device looks identical to the experimental device but has the vibration~     component removed.~   "
113384|NCT02083328|"~     The aim is to investigate the influence of caffeine on heart rate variability and on~     performance in a 3 min exercise test in different population groups (able-bodied, paraplegic~     and tetraplegic subjects).~      In general, the investigators are interested in the differences between the heart rate~     variability before and after caffeine supplementation and if the subjects exercise~     performance is enhanced using this type of supplementation. Another objective is to see~     whether there are differences between able-bodied and disabled subjects.~      Tetraplegic subjects showed in some previous studies no Low-Frequency-component (LF) for~     heart rate variability and no increase in catecholamines after the ingestion of caffeine.~     Therefore the investigators think, that tetraplegic subjects won`t show any ergogenic effect~     in exercise performance after the intake of caffeine. On the other hand, paraplegic subjects~     should show similar differences of heart rate variability after the ingestion of caffeine as~     able-bodied subjects. Paraplegic subjects should benefit from caffeine supplementation in an~     increase in exercise performance.~   "
113385|NCT02083315|"~     This study is designed to compare TRV130 to placebo and morphine to learn about its effects~     on pain relief and side effects.~   "
113386|NCT02083302|"~     The purpose of this study was to examine the impact of a bystander intervention education~     program on college students' attitudes and behaviors associated with bystander intervention~     and sexual violence.~   "
113387|NCT02083289|"~     The primary objectives of this study are to compare the safety, tolerability, and mean change~     from baseline in diurnal intraocular pressure (IOP) of ONO-9054 30 µg/mL (0.003%) to~     latanoprost 0.005% following ocular instillation once every evening for 28 days.~   "
113388|NCT02083276|"~     The mainstay of treating both symptomatic and asymptomatic genital Chlamydia trachomatis~     infection has been macrolide antibiotics in the form of azithromycin, and alternatively~     tetracycline antibiotics in the form of doxycycline. Studies from the late nineties found a~     single dose of 1 g azithromycin to be equally effective as a 7 day course of 200 mg~     doxycycline a day. However, recent studies have reported increasing treatment failure that~     may indicate that resistance to macrolide antibiotics among Chlamydia trachomatis is~     evolving. Research regarding other bacterial species indicates a high frequency of mutation~     based resistance in conjunction with azithromycin use, i.e. when treating Mycoplasma~     genitalium infections. There has only been case reports of tetracycline resistance among~     human Chlamydia isolates, but a recent study suggest that there might be decreasing~     effectiveness also for doxycycline. Veterinaries has for several years observed increasing~     prevalence of tetracycline resistance among Chlamydia suis. Within the Chlamydia population~     there is promiscuous horizontal gene transfer.~      If the current trend of declining cure rates continues, the investigators might face a~     situation where there are no documented and effective treatments for Chlamydia trachomatis~     infections. This underline an urgent need to expand the number of documented treatment~     options and mecillinam seems to be one of the options that warrant further investigation.~      The objectives of this study is to prove the concept of treating genital Chlamydia~     trachomatis with mecillinam (Pivmecillinamhydrochlorid).~   "
113389|NCT02083263|"~     With the use of Non invasive ventilation the patients with cystic fibrosis will have better~     lung function (FEV1).~   "
113390|NCT02083250|"~     The goal of this clinical research study is to evaluate the safety of combining vorinostat~     (also called SAHA) with fludarabine, clofarabine, and busulfan.~      If you are reading and signing this form on behalf of a potential participant, please note:~     Any time the words you, your, I, or me appear, it is meant to apply to the potential~     participant.~      This is an investigational study. Fludarabine, clofarabine, and vorinostat are FDA approved~     and commercially available for the treatment of cancer. Busulfan is also FDA approved for use~     with stem cell transplants. The use of these drugs together with a stem cell transplant is~     investigational. The study doctor can explain how the study drugs are designed to work.~      Up to 72 patients will take part in this study. All will be enrolled at MD Anderson.~   "
130116|NCT01864252|"~     The purpose of this study is to determine whether Glyceryl Trinitrate (GTN) reduces injury to~     the heart during heart-lung bypass surgery in combination with the newer technique of remote~     ischaemic preconditioning (RIPC).~   "
113391|NCT02083237|"~     Mild cognitive impairment (MCI) is a significant risk factor for dementia. Persons with MCI~     experience cognitive changes, most typically affecting memory; that are greater than those~     experienced in normal aging. However, these cognitive changes in MCI, unlike in dementia,~     are not significant enough to markedly interfere with functional independence. In addition to~     cognitive change, some people with MCI also experience elevated symptoms of depression and~     anxiety, which adds to their risk of developing dementia. Close family are also impacted by~     their relative's MCI and show mild physical (e.g., increased incidence of systemic health~     problems such as high blood pressure) and mental health declines (e.g., elevated symptoms~     associated with depression and anxiety) that are similar, though not as severe, to those~     experienced by caregivers of a relative with dementia. Programs aimed at behavioural~     intervention have real potential to reduce and/or prevent negative health outcomes associated~     with MCI and future dementia by promoting positive behaviour changes. We wish to~     scientifically establish the utility of a behavioural intervention aimed at addressing the~     needs of both the person with MCI and their close family member, with the ultimate goal of~     lowering current and future susceptibility to mental health declines and chronic disease in~     people living with MCI. We have an 8 session (16 hour) program, where participants with MCI~     and their close relative are together for the first half of each session, which is devoted~     primarily to enabling positive lifestyle choice. In the second hour the group splits up, with~     MCI clients engaging in memory training while their close family member participates in a~     psychosocial intervention.~   "
113392|NCT02083224|"~     Clinical cancer genetics is an emerging new field in medical oncology, and has been~     incorporated into routine oncology practice in many leading medical institutions in North~     America and Europe. Cancer genetics is the study of genetic factors contributing to~     carcinogenesis. In the last 5-10 years, genes responsible for various well-defined hereditary~     cancer syndromes have been cloned. These include the BRCAJ/2 genes in hereditary breast and~     ovarian cancer syndrome, the A4PC gene in Familial Adenomatous Polyposis, and the mismatch~     repair genes (hMLH1, hMSH2, hPMS1, hPMS2, hMSH6) in hereditary non-polyposis colorectal~     cancer (HNPCC). One of the goals of a clinical cancer genetics service is to identify~     families at risk for hereditary cancer syndromes, provide genetic counseling, and offer~     genetic testing when appropriate. The identification of causative genes in hereditary cancer~     syndromes together with the advent of genetic testing is starting to have an impact on~     clinical management. The ability to identify a gene mutation in a cancer family allows~     predictive testing, stratifying at-risk family members into carriers who will benefit from~     aggressive surveillance and/or preventive options, and non-carriers who may be spared~     unnecessary surveillance. Appropriate use of genetic testing will ultimately result in~     medical cost reduction.~      The investigators hypothesize that the clinical characteristics and genetic factors~     contributing to hereditary cancer in the Singaporean Asian population are distinct from those~     described for Western patients.~   "
113393|NCT02083211|"~     This study evauates the global survival of patients following administration of mAb~     Nimotuzumab hR3 + chemotherapy in the treatment of cervical cancer in first line therapy,~     after relapsing from chemo-radiotherapy.~      It is a Phase III, multi-centric, randomized, double blind study; 168 patients will be~     assigned to Nimotuzumab + Cisplatin/Vinorelbine or placebo + Cisplatin/Vinorelbine. After~     progression, a second line chemotherapy based on carboplatino/taxol will be administered in~     both groups. Concomitant administration of Nimotuzumab will be continued every 14 days until~     limiting toxicity or ECOCG >3.~      Tumor markers such as Kras, p53, KI67, and EGFR will be identified. Cardiac toxicity will be~     evaluated using MRI.~   "
113394|NCT02083198|"~     This observational study evaluates the impact of high and low chloride containing IV fluids~     on administrative and clinical outcomes. The study uses a large electronic health dataset and~     examines patients receiving fluid replacement and resuscitation. The hypothesis is that high~     chloride solutions are associated with adverse outcomes as measured by administrative data~     and by clinical parameters.~   "
113395|NCT02083185|"~     The purpose of this study is to evaluate the efficacy of TAK 385 for achieving and~     maintaining testosterone suppression (<50 ng/dL).~   "
113396|NCT02083172|"~     The primary objective of this study is to evaluate the agreement between hemodynamic~     measurements obtained using the Ultrasound Cardiac Output Monitor (USCOM®; USCOM Ltd.,~     Sydney, Australia), and reference standards as determined by 2 Dimensional echocardiography~     (2D-echo) measurements in a group of hemodynamically stable and unstable pediatric patients.~   "
113397|NCT02083159|"~     Non-alcoholic fatty liver disease (NAFLD) is characterized by an accumulation of fat in the~     liver, which is one of the most common forms of chronic liver disease in developed countries.~     In western countries, the prevalence of NAFLD in the general population is estimated to be~     20-30%; in obese populations, this increases to 57.5-74%. But, it hasn`t been clearly~     elucidated yet regarding the underlying disease pathophysiology and treatmet strategy.~      Recently, members of the C1q/tumor necrosis factor-related protein (CTRP) family have been~     reported to share structural homology with adiponectin. To date, 15 CTRP family members have~     been found that might play major roles in glucose metabolism and inflammation.~      The investigators tried to clarify the relationship between CTRP family and NAFLD in Korean~     men and women.~   "
113398|NCT02083146|"~     Now, adipose tissue is established as an active endocrine organ that controls systemic energy~     homeostasis by secretion of adipokines. Recently, members of the C1q/tumor necrosis~     factor-related protein (CTRP) family have been reported to share structural homology with~     adiponectin. To date, 15 CTRP family members have been found that might play major roles in~     metabolism and inflammation. The investigators tried to clarify the relationship between CTRP~     family and coronary artery disease (CAD) in Korean men and women.~   "
113399|NCT02083133|"~     The purpose of this study is to assess whether the current recommendation for a 50% dose~     reduction in insulin for diabetic patients with a creatinine clearance (CrCl) ≤15 mL/min or~     on hemodialysis results in an increased number of hypoglycemic episodes.~   "
113432|NCT02082678|"~     The purpose of the study is to determine if ondansetron, as an add-on therapy, is associated~     with reduced depressive symptoms and alcohol use in outpatients with bipolar disorder (BPD),~     cyclothymic disorder, schizoaffective disorder (bipolar type) and major depressive disorder~     (MDD) with mixed features. The investigators will also use blood samples to determine if the~     genotype for the serotonin transporter gene is associated with response to ondansetron.~   "
113400|NCT02083120|"~     The effects of a nasal high-flow (NHF) therapy in patients with chronic obstructive~     hypercapnic respiratory failure are still not sufficiently known yet.~      The aim of this study is a step-by-step generation of physiological data about gas exchange~     and respiration under high flow therapy using a nasal cannula with an AIRVO 2 device to~     provide NHF, leading to an analysis of the effects of high flow on PCO2 levels, exercise~     capacity, quality of life and gas exchange in a long term home treatment compared to a~     standard low flow long term oxygen therapy (LOT).~      Hypothesis: NHF and LOT therapy show differences in measured mean overnight transcutaneous~     carbon dioxide partial pressure (PCO2) after four weeks of treatment.~   "
113401|NCT02083107|"~     The aim of the work is to evaluate & compare the effectiveness of rectally administered PGE1~     synthetic analogue (misoprostol) 400 microgram versus sublingually administered misoprostol~     before caesarean section to decrease blood loss during and after the operation.~   "
113402|NCT02083081|"~     In the southwest region of Alaska where the project takes place, 79% of Alaska Native women~     smoke cigarettes or use smokeless tobacco (ST) during pregnancy. In addition, pregnancy~     appears to be a high risk period for initiation of tobacco use, primarily ST, among women~     reporting no use of tobacco 3 months before pregnancy. Intervention efforts targeting the~     entire community, not only pregnant women, to address social norms about tobacco use may be~     effective. Thus, the investigators will evaluate the efficacy of a novel, multi-component,~     theory-based intervention for reducing tobacco use during pregnancy, incorporating both~     individually targeted and community level components delivered by female elders Native~     Sisters. The intervention builds on effective community and individual-based approaches for~     tobacco cessation and lay health advisor approaches for cancer prevention among Native~     American women. As part of the intervention, a social marketing campaign including digital~     stories and other small media will be developed with community feedback. Individually~     targeted components will be six 30-40 minute telephone or home-based peer counseling sessions~     with pregnant women.~   "
113403|NCT02083068|"~     This is a randomized, double-blind, controlled, which seeks to compare two groups of~     volunteers (naive and previously exposed to malaria) who were made 3 immunizations with a~     synthetic derivative of the CS protein of Plasmodium vivax in order to determine their~     protective efficacy. Then volunteers will be subject to an infectious challenge to assess the~     infectivity of gametocytes in the blood early stage of P. vivax in Anopheles albimanus~     mosquitoes.~   "
113404|NCT02083055|"~     The aim of this study was to evaluate the positive anesthetic properties such as reduce~     intraoperative analgesic requirement, time to extubation and recovery, and early~     postoperative pain of dexmedetomidine used as a hypotensive agent compared with~     nitroglycerin.~   "
113405|NCT02083042|"~     This study aims to validate whether Lophius Biosciences Kit T-Track® CMV is suitable to~     assess the functionality of CMV-specific cell-mediated immunity (CMI) and to determine a~     protective cut-off value for CMV reactivations/disease in kidney transplant recipients.~      Lophius kit T-Track® CMV represents a highly standardized and sensitive diagnostic tool to~     assess the functionality of a network of clinically relevant CMV-reactive effector cells. It~     is based on the stimulation of peripheral blood mononuclear cells (PBMC) with urea-formulated~     immunodominant CMV proteins, pp65 and IE-1, and the subsequent quantification of CMV-specific~     CMI (spot forming colonies) using a highly sensitive IFN-γ ELISpot.~   "
113406|NCT02083029|"~     The investigators' hypothesis is that dysregulation of autonomic function, as revealed during~     a simulated dive reflex, may result in an attenuation of the heart rate response to a greater~     degree in asthmatics who collapse during exacerbations of asthma than that seen in healthy~     individuals and in asthmatics without a history of syncope. The investigators will test this~     by assessing autonomic function through a dive reflex protocol.~   "
113407|NCT02083016|"~     Ultra-high density mapping with multielectrode catheter may improve slow conduction channels~     identification in ventricular tachycardia substrate ablation procedures compared to~     conventional point by point mapping.~      This study compares the ability of both mapping catheters to detect slow conduction channels~     in areas of myocardial scar and their utility to assess substrate modification after~     ablation.~   "
113408|NCT02083003|"~     It has been shown that N-methyl-D-aspartate (NMDA) receptor antagonists (such as ketamine)~     potentiate analgesic drug's efficacy. Polyamines are allosteric modulators of NMDA receptors.~     In animal studies, polyamine-free diet has shown antinociceptive properties. This research~     aims at evaluating analgesic properties of polyamine-low diet after laparoscopic~     cholecystectomy performed in an ambulatory setting.~   "
113409|NCT02082990|"~     Brief Interventions (BIs) for risky drinkers are an effective tool in primary care. Lack of~     time in daily practice has been identified as a barrier for the wide implementation of BI.~     There is growing evidence that e-health tools such as web based BIs can be an efficient~     alternative to standard face-to-face BIs and save time to general practitioners (GP).~      The main aim of this study is to test non-inferiority of a web based BI for risky drinkers~     against a traditional face to face BI delivered by a general practitioner. We have designed a~     randomised controlled non-inferiority trial comparing both interventions, to be performed in~     primary care health centres in Catalonia, Spain.~      Adults attending in primary care centres and willing to participate, will be invited to fill~     the short Alcohol Use Disorders Identification Test (AUDIT-C) in a specific website. Those~     screening positive and who accept to share the baseline data with their GP will be invited to~     an online assessment of their drinking and randomized to a standard BI with their GP or to~     the online BI.~      Follow-up assessment will be conducted online at months 3 and 12, using the full Alcohol Use~     Disorder Identification Test (AUDIT) and the quality of life questionnaire (D5-EQD5). The~     main outcome will be the proportion of risky drinkers according to the AUDIT. Assuming a 30%~     reduction in the proportion of risky drinkers in the control group (classroom), allowing for~     an overall attrition of 10% of patients in the trial and non-inferiority assessed against a~     specified margin of 10%, it is estimated that 500 patients would be required in each group to~     give the test a 90% power (1-β) to reject the null hypothesis.~   "
113461|NCT02082301|"~     This is an observation study of women with gestational diabetes. Subjects recruited undergo~     immediate postpartum diabetic screening prior to discharge. Post-partum screening for overt~     diabetes is repeated 6-12 weeks postpartum. The outcome of interest is the utility of an~     immediate post partum screen for overt diabetes compared to a traditional 6 week test.~   "
113410|NCT02082977|"~     This is an open-label, multicenter, 2-part study to determine the recommended Phase 2 dose~     (RP2D) for GSK2816126 given twice weekly by intravenous (IV) infusion. Part 1 will be~     conducted in adult subjects with relapsed/refractory diffuse large B cell lymphoma (DLBCL),~     transformed follicular lymphoma (tFL), other Non-Hodgkin's lymphomas (NHL), solid tumors~     (including castrate resistant prostate cancer) and multiple myeloma (MM) to determine the~     safety and tolerability of GSK2816126. Expansion cohorts (Part 2) are planned to further~     explore clinical activity of GSK2816126 at the RP2D in subjects with Enhancer of Zeste 2~     (EZH2) wild type and EZH2 mutant positive germinal center B-cell like diffuse large B cell~     lymphoma (GCB-DLBCL), tFL and MM.~   "
113411|NCT02082964|"~     In this randomized controlled trial 48 students were randomly allocated in three groups SCIM,~     Video training (VT) and control group(no training). They had a workshops based on NRP and~     lasted 6 hours for each group. Before and after the workshops and one month later all~     students participated in a 7 station OSCE..~   "
113412|NCT02082951|"~     The objective was to compare the frequency and intensity of symptoms of anxiety in patients~     of preoperative cardiac surgery who received empathic behaviour from nurse or family or those~     who received no specific type of empathic behaviour. This is a randomized clinical trial. The~     sample consisted of 66 patients in preoperative of cardiac surgery, who were divided in three~     groups: empathic behaviour by nurses, without specific empathic behaviour and by family.~     Anxiety was assessed at two time points: before and after the intervention. The instrument~     used was developed and validated, comprising 19 defining characteristics of the nursing~     diagnosis anxiety. The hypothesis is that the group who received empathic behaviour from~     nurse or family will reduce the anxiety.~   "
113413|NCT02082938|"~     The purpose of this study is to verify if the incorporation of a new brace, which assists in~     gait rehabilitation, can contribute to the rehabilitation process for stroke patients.~   "
113414|NCT02082925|"~     In view of the multiple limitations and restrictions relative to CPET (technical, time,~     physical…), determination of individualized training threshold from this evaluation is today~     not possible for a lot of patients.~      The aim of this study was to propose a new clinical tool from 6MWT for individualized~     exercise training: the dyspnea threshold (DT6).~   "
113415|NCT02082912|"~     The purpose of this study is to focus on enhancing upper limb recovery in patients~     post-stroke by using robotic-assisted therapy in combination with a drug to improve learning~     new motor skills.~   "
113416|NCT02082899|"~     This is a Phase II Single Center, Randomized, Double-Masked, Vehicle-Controlled, Parallel,~     Group Study to Assess the Efficacy of EBI-005 Topical Ophthalmic Solution for the Treatment~     of Moderate to Severe Allergic Conjunctivitis Using an Environmental Exposure Chamber (EEC)~     Model and Conjunctival Allergen Provocation Test (CAPT) Model. Approximately 150 subjects~     will be enrolled and randomized in one study center in Canada for a duration of 0.33 years.~   "
113417|NCT02082886|"~     In this registry study the investigators will collect data about patients' disease,~     treatment, and response to treatment to include in both our local and national databases.~     These can then be used by investigators to answer questions about cytoreductive surgery/HIPEC~     such as how well-tolerated or effective it is in specific populations.~   "
113418|NCT02082873|"~     This research is being conducted to determine if Neuroscience intensive care unit (ICU)~     nurses are able to identify seizures by reviewing quantitative EEG (qEEG) that is running at~     the bedside. QEEG is the application of mathematical and analytical techniques to analyze EEG~     signals. Several hours of data can be displayed on a single screen in several graphical~     panels. Routine evaluation of EEG data consists of manual inspection of each page of EEG data~     by a trained neurophysiologist (a neuro ICU doctor) and can be quite time-consuming. In most~     cases, this data can only be reviewed intermittently and interpretation is almost always~     relayed to the primary clinical team after the seizures have occurred. Theoretically,qEEG~     graphical displays can provide a simplified view of complex EEG data that could possibly be~     used by non-neurophysiologists, such as Neuro ICU nurses. Our hypothesis is that Neuro ICU~     nurses are able to accurately identify recurrent seizures in real-time.~   "
113419|NCT02082860|"~     This is a Phase I trial aimed to determine the safety of the investigational gene therapy~     product (rAAV2/5-PBGD) for the treatment of Acute Intermittent Porphyria (AIP).~      Up to eight patients fulfilling the eligibility criteria will participate in this~     multicentre, open label, single dose, dose-ranging Phase I clinical trial.~      The enrolled patients will be followed up to assess the safety profile of the investigational~     gene therapy product and to establish the maximum therapeutic safe dose to be administered in~     future confirmatory/pivotal clinical trial(s). In addition, the biological and clinical~     response to the treatment with rAAV2/5-PBGD in AIP patients will be assessed.~      A complete evaluation of the clinical (symptoms and quality of life assessment) and~     laboratory (blood and urine) data will be performed.~   "
113420|NCT02082834|"~     The purpose of the study is to compare the accuracy of the diagnosis of endoleak in patient~     with EVAR comparing Adaptive statistical iterative reconstruction (ASIR) CTA and Model-based~     iterative reconstruction (MBIR- VEO TM).~   "
113433|NCT02082665|"~     This is an open-label, multi-center, fixed sequence study in subjects with BRAF V600 mutation~     positive tumors. Subjects will receive single oral doses of 10 milligram (mg) of rosuvastatin~     and 3 mg of midazolam in the morning of Day 1 (alone), Day 8 (with first dose of dabrafenib~     150 mg), and Day 22 (during repeat dose dabrafenib 150 mg twice daily [BID]). Dabrafenib 150~     mg BID will be administered from Day 8 to Day 23. Blood samples for PK analysis will be~     obtained over 32 hours post-dose on Day 1, Day 8, and Day 22. The last dose of dabrafenib~     will be taken in the morning of Day 23 and the last blood sample in the evening of Day 23.~     Subjects will be considered to have completed the study once the 32 hour PK sample has been~     collected on Day 23. Once they have completed the study, eligible subjects may have the~     option to enter study BRF114144, an open-label roll-over study of dabrafenib (no follow-up~     visit required) and continue receiving dabrafenib.~   "
113462|NCT02082288|"~     Purpose of this study is to detect outcome of intracytoplasmic sperm injection (ICSI)~     according to EIOS~   "
113785|NCT02078089|"~     This is an open-label, single arm, Phase Ib dose escalation study of Oxcarbazepine with~     morphine in patients with refractory cancer pain. The primary endpoint is to evaluate the~     safety and toxicity of the combination of Oxcarbazepine plus morphine. The secondary~     endpoints are improving pain control, reduce morphine use and improve the quality of life.~   "
113421|NCT02082821|"~     Heart transplantation (HT) is a lifesaving procedure for patients with end-stage heart~     failure and provides a better survival and quality of life if compared to medical treatment.~     HT is subject to alloimmune response, which, if left uncontrolled, is capable of jeopardizing~     long-term cardiac function. Advances in immunosuppression have enhanced the survival of HT~     patients. Nearly 2500 HT per year have been performed in the US during the last 10 years and~     despite significant improvements, long-term survival rates remain poor. More than 20% of~     patients do not survive more than 3 years, and those who survive are afflicted by long-term~     complications of alloimmunity and chronic immunosuppression. Life expectancy of patients who~     lose cardiac allografts is dramatically poor due to the absence of any therapeutic tool apart~     from re-transplantation, which is plagued by poor outcomes. The identification of novel~     therapeutic targets is thus mandatory. ATP/P2X7R signaling in T cells is highly relevant for~     cardiac allograft survival. ATP is a small molecule present at high concentrations inside~     cells; it is released as extracellular ATP (eATP) following cell damage or death where it~     acts as a danger signal. ATP is sensed by the P2X receptors (seven receptors named P2X1-7),~     mainly expressed by T lymphocytes. We have recently demonstrated that the ATP/P2X7R axis has~     a key role in cardiac allograft survival in humans and mice. Cardiac allograft vasculopathy~     (CAV) is a major limiting factor for HT survival; indeed CAV occurs in 50% of HT recipients~     by 5 years after transplantation and invariably results in allograft failure. CAV is clearly~     of immunological origin, as syngeneic murine grafts do not develop it. Once CAV occurs, the~     most definitive treatment is re-transplantation, but survival remains poor. We hypothesize~     that a single nucleotide polymorphysm (SNP) loss-of-function P2X7R mutation (p.Glu496Ala /~     c.1513A>C, rs3751143) generates a compensatory upregulation of the other purinergic receptors~     (P2XsR), thus creating a state of hypersensitivity to eATP. This eATP hypersensitivity~     results in an abnormal generation of Th1/Th17 cells, that leads to CAV and early cardiac~     allograft loss. Our study will answer a fundamental question: What is the effect of the P2X7R~     loss-of-function mutation on the immune system? Our goal is to generate the first~     targeted-therapy for a selected group of cardiac transplant recipients.~   "
113422|NCT02082808|"~     This study is designed to estimate the two-way drug interaction between DCV and DTG as a drug~     interaction between DTG and DCV is expected to be low and this study is to be performed as~     confirmation. This will be a single-center, open-label, three-period, crossover study in~     healthy adult subjects. This study to describe and compare steady-state plasma DTG and DCV~     pharmacokinetics following administration of DTG 50 mg q24h with and without DCV 60 mg q24h~     and following administration of DCV 60 mg q24h with and without DTG 50 mg q24h also the~     safety and tolerability was assessed after a repeat dose DTG 50 mg q24h with or without DCV~     60 mg q24h and after a repeat dose DCV 60 mg q24h with and without DTG 50 mg q24h~   "
113423|NCT02082795|"~     The investigators aim to perform a qualitative study to explore the views of women with a~     breech presentation on their management in general, and the use of anaesthesia or analgesia~     for ECV in particular.~   "
113424|NCT02082782|"~     Irreversible electroporation (IRE) is a new, minimal-invasive image-guided treatment method~     for tumors not amenable for surgical resection or thermal ablation, due to vicinity near~     vital structures such as vessels and bile ducts. With IRE, multiple electrical pulses are~     applied to tumorous tissue. These pulses alter the existing transmembrane potential of the~     cell membranes, and create 'nanopores', after which the cell dies through loss of~     homeastasis.~      The purpose of this study is to investigate the efficacy of percutaneous and open IRE in the~     treatment of patients with colorectal liver metastases (CRLM) that are unsuitable for~     resection or thermal ablation due to vicinity to vulnerable structures such as vessels and~     bile ducts. Other objectives are safety, feasibility (technical success) and imaging~     characteristics on follow-up (PET-)CT and PET-MRI and the value of these imaging modalities~     in dianosing local site recurrence (LSR) or residual disease (RD).~      29 patients with histologically confirmed colorectal carcinoma who present with unresectable~     and not thermally ablative CRLM< 3.5cm suitable for IRE will undergo percutaneous or open~     irreversible electroporation of the tumor using CT and ultrasound guidance. All (serious)~     adverse events are registered. One day post-IRE MRI is performed to assess technical success.~     Follow-up will consist of frequent (PET-)CT and (PET-)MRI scanning to localize residual or~     recurrent disease. Overall technique effectiveness is determined 1 year after treatment.~      The investigators hypothesize that IRE for central CRLM will lead to good tumor control~     without causing severe complications.~   "
113425|NCT02082769|"~     The purpose of this study is to compare febuxostat allopurinol in subjects with gout.~   "
113426|NCT02082756|"~     The aim of this study is to assess the beneficial effects of Bifidobacterium and Berberine~     Hydrochloride on lowering glucose and delaying progress to diabetes in patients with~     prediabetes and to detect the potential mechanism.~   "
113427|NCT02082743|"~     The purpose of this study is making use of school policy- recess outside classroom (ROC7-11)~     for increasing the time spent outdoor during recess and encouraging children spent time~     outdoor up to 11 hours in each week to investigate the vision change, myopia onset and~     progression in these schoolchildren.~   "
113428|NCT02082730|"~     This study aims to improve on the delivery of treatment for people with Chronic Fatigue~     Syndrome/Myalgic Encephalomyelitis (CFS/ME). People with CFS/ME have low energy. This~     interferes with doing everyday activities and has a major impact on quality of life. Energy~     management is a key aspect of treatment and involves patients building up their energy levels~     gradually. Their health professional finds out how much energy the patient uses daily so they~     can prescribe how much activity and rest is right for the patient. The prescription is~     adjusted throughout treatment. Over time, the patient learns the best way to spend and~     preserve energy. To begin treatment, patients record their activity levels on paper over a~     few weeks. Records need to be accurate, but this is often difficult because of problems with~     memory, concentration or low energy and pain.~      We have recently developed a new technology called ASARM (Advanced Sleep Rest Activity and~     Rest Management) that records activity levels electronically and checks whether they match~     the activity prescription. The ASARM device is worn on the patient's wrist. It measures~     sleep, activity and rest, and has an electronic diary (a smartphone app) for recording daily~     activities. The health professional has remote access to the information and uses the app to~     change the prescription. This study will investigate if ASARM is (i) acceptable to patients;~     (ii) a good way to deliver Cognitive Behavioural therapy CBT treatment; (iii) able to improve~     their symptoms. Patients and clinicians will gain experience of ASARM for a short time, and~     we will analyse their data. Our findings will help us develop ASARM so that it can be used in~     routine care of CFS/ME patients.~   "
113429|NCT02082717|"~     The purpose of this study is to examine the impact of 4% sodium bicarbonate additive during~     peripheral intravenous potassium chloride replacement therapy for adult patients in a~     Medical/Surgical unit. Using a randomized controlled double blinded experimental study~     design, patients who are 21 years or older are alert, awake, and oriented at the time of~     enrollment and have been ordered peripheral intravenous potassium chloride replacement will~     be recruited from one Medical/Surgical during the first 24-48 hours of their admission.~   "
113434|NCT02082652|"~     Antiretroviral therapy (medicines used to treat HIV) can interact with hormonal~     contraceptives which might decrease their effectiveness. The single-rod etonogestrel~     contraceptive implant is being more commonly used in low- and middle-income countries because~     if the ease of insertion and removal. Efavirenz and nevirapine are first-line HIV medicines~     in Sub-Saharan Africa and this study will help determine an effective way to use these~     medicines with the etonogestrel implant. The investigators hypothesize that women receiving~     nevirapine- or efavirenz-based antiretroviral therapy will have lower etonogestrel levels in~     their blood after six months of insertion as compared to women not taking antiretroviral~     therapy.~   "
113435|NCT02082639|"~     The purpose of this study is to evaluate the immunogenicity and safety of two doses of GSK~     Biologicals' HPV-16/18 L1 VLP AS04 vaccine when co-administered with GSK Biologicals' HAV~     vaccine according to 0, 6 month schedule, compared to the administration of either of these~     vaccines alone. The study will ascertain that the immune responses elicited to the two~     vaccines are not adversely impacted compared to when HPV-16/18 L1 VLP AS04 vaccine and HAV~     vaccine are administered alone.~   "
113436|NCT02082626|"~     This is a study for children with cancer with no curative treatment options. The~     investigators will be giving eribulin, a new chemotherapy agent, for the first time to~     children. This study is designed to determine a safe dose the investigators can give to~     children in larger studies. The investigators will be monitoring the children on this study~     for the safety of the treatment and levels of eribulin in the blood after treatment. The~     investigators will also study the effect of the agent on the cancer.~   "
113437|NCT02082613|"~     This study will compare a minimal invasive operation in local anesthesia with sclerotherapy~     for symptomatic testicular hydrocele within 6 months after randomization. Thirty days~     complication rates will be assessed. The hypothesis is that surgery will lead to faster cure~     while sclerotherapy would be cheaper and have less complications.~   "
113438|NCT02082600|"~     The aims of this study are examine the effects of sleep deprivation in muscle recovery after~     a maximum eccentric resistance exercise session performed on an isokinetic dynamometer (24~     series of 10 repetitions). The sample will consist of 10 men, sedentary, clinically healthy,~     aged between 20 and 31 years old. Two experimental groups will be developed: EXE-SLEEP, in~     which subjects will perform the exercise protocol (~18:00-19:00) and will be subject to~     normal period of sleep for 3 nights; EXE-TOTAL, in which subjects will perform the same~     exercise protocol and will be sleep deprived for 60 hours, followed by one night of sleep~     rebound.~   "
113439|NCT02082587|"~     As treatments improve and patients live longer with cancer, even after it has spread to the~     brain, efforts to improve quality of life are growing. Neurocognitive function (thinking~     ability and memory) is an area of particular concern for patients with brain metastases~     (cancer that can spread to the brain). Although there are established tests to measure~     neurocognitive function, these require a face-to-face assessment and can take a long time to~     complete. As a result, efforts to use these tests to measure changes in neurocognitive~     function in patients following treatment for brain metastases have resulted in a large~     proportion of patients who do not return for follow-up. This has limited the ability to~     evaluate the impact of current treatments on neurocognitive function. This study aims to~     evaluate a shorter, telephone-based neurocognitive assessment tool, which would make it~     easier for patients to complete these tests in follow-up. If this new tool is found to~     reliably measure neurocognitive function, it could be used for future studies evaluating new~     interventions that prevent or treat neurocognitive deterioration following treatment of brain~     metastases. This is the first prospective study to evaluate the feasibility and reliability~     of a novel telephone-based brief neurocognitive assessment battery (Toronto BNB) compared~     with the same battery delivered face-to-face in this population. The investigators~     hypothesize that telephone administration of this brief neurocognitive battery will reliably~     evaluate neurocognitive function and improve patient ability to complete follow-up~     assessments.~   "
113440|NCT02082574|"~     Cerebral small vessel disease (CSVD) is a major cause of cognitive impairment and disability~     in the general population, secondary to the accumulation of asymptomatic elementary lesions.~     CSVD is directly correlated with age and cardiovascular risk factors and therefore would be~     challenging in term of public health care in the future. While HIV patients share the same~     cardiovascular risk factors and they are often diagnosed with cognitive impairment and~     frailty, CSVD has not been yet described in this population.~      The global aim is to compare the prevalence of CSVD in a well controlled HIV+ population~     compared to HIV- controls matched with age and sex.~      500 HIV+ patients and 250 age- and sex- matched controls will undergo a screening of the CSVD~     with a 10 minutes MRI (FLAIR and T2*).~      Prevalence of the CSVD will be compared between HIV+ patients and controls. General and~     HIV-specific parameters from their electronic medical records will be compared between~     HIV+/CSVD+ and HIV+/CSVD- patients.~      We are expecting to prove that CSVD is more frequent in HIV+ population.~   "
113441|NCT02082561|"~     The aim of the current study was to test the efficacy of an individually administered, brief~     (5-session) transdiagnostic treatment for anxiety disorders. The current treatment (called~     F-SET) focuses chiefly on the elimination of anxiety maintaining behaviors and cognitive~     strategies (so-called safety aids) among individuals suffering from a range of anxiety~     disorders including generalized anxiety disorder (GAD), social anxiety disorder (SAD) and~     panic disorder (PD). We hypothesized that the F-SET protocol would produce better overall~     outcome relative to a waitlist control.~   "
113442|NCT02082548|"~     To determine whether a comprehensive evaluation and customized multilevel educational~     interventions will increase the rate of use of oral anticoagulants and the adherence and~     persistence of use in patients with atrial fibrillation. Our hypothesis is that there will be~     differences in the use of oral anticoagulants and the persistence in patients between the~     control and interventional group. There will be a greater change in the use of oral~     anticoagulants over one year in the cohort in the intervention sites than the control sites.~     This will be due to two factors: greater initiation of oral anticoagulants among patients not~     treated at baseline and greater persistence of treatment for those on treatment at baseline~   "
113786|NCT02078076|"~     Clinical, prospective and monocentric study aiming at assessing the feasibility of fibrosis~     detection and quantification (and of function assessment) during MRI without breath-holds in~     a population of adults and children with Duchenne myopathy.~   "
113443|NCT02082535|"~     The improvement of treatment of preterm neonates improved their survival, however there is~     still significant portion of preterm infants (specifically very preterm infants) that suffers~     from brain insults and as a result developmental deficits. The brain injury is a consequence~     of hypoxic ischemic events, intracranial hemorrhages, as well as, infections and metabolic~     crisis. The brain injury is a combination of abnormal myelination, axonal damage and neuronal~     death. Although there is reduction in focal brain injury, diffuse brain injury is still~     abundant. Several treatments has been suggested and tested in animal models to prevent the~     brain insults including glutamate receptor blockers, allopurinol, xenon and different types~     of stem cells. However, two main obstacles prevent the use of these medication, first the~     uncertainty of their effect on the developing brain and second the difficulty to time the~     brain insult. Unlike neonatal asphyxia, when the delivery time and clinical signs are used to~     time and grade the brain injury, in preterm infants there is no real time tool to indicate~     severity and timing of brain injury. The disability point out a beneficial therapeutic window~     is a major obstacle in the acute treatment of brain injury in preterm infants. The aim of~     this study is to try and delineate such therapeutic window by using brain injury biomarkers.~      S100b and GFAP are well recognized biomarkers of brain injury in adults, children and~     infants. Serial measurements of S100b in saliva (every 2 days) and GFAP in serum (weekly)~     will be sampled. A database of the clinical status of the infants will be collected, as well~     as, head ultra sound weekly and head MRI a term age. Development will be assessed by at 18~     months. Two hypotheses are stated: One, increase in the levels of S100b and GFAP in their~     timing will be correlated with the severity of the clinical status, Two the duration of~     increased level of S100b and GFAP will be associated with abnormal MRI at term findings and~     abnormal developmental assessment.~   "
113444|NCT02082522|"~     Photodynamic therapy (PDT) is a combination of a drug, porfimer sodium (Photofrin), which is~     activated by a light from a laser that emits no heat. This technique works to allow the~     medical doctor to specifically target and destroy abnormal or cancer cells while limiting~     damage to surrounding healthy tissue. The activation of the drug is done by lighting the~     abnormal areas using a fiber optic device (very fine fiber like a fishing line that permits~     light transmission) inserted into a flexible tube with a light called cholangioscope for the~     bile duct. The light will activate the porfimer sodium concentrated in the abnormal tissue,~     leading to its destruction.~      This research study will evaluate the efficacy and safety of PDT with porfimer sodium~     administered with Standard Medical Care (SMC) compared to SMC alone on the overall survival~     time of patients with non-operable advanced cholangiocarcinoma, a rare cancer of the bile~     ducts. It will involve 200 patients across North America and Europe. Other countries may~     participate if needed. Participation will last at least 18 months.~   "
113445|NCT02082509|"~     One of the most common symptoms suffered by traumatic brain injury (TBI) patients is~     disruption in attention. Lack of attention impacts daily life including academic or~     professional tasks, and interpersonal relationships. The focus of Therapeutic Resources for~     Attention Improvement with Neuroimaging for Traumatic Brain Injury (TRAIN-TBI) is to~     investigate the changes in neurological function with special interest in attention after TBI~     for children ages 8 to 16. This study will be done through advanced neuroimaging procedures,~     neurocognitive testing, and an online training tool created by The Brain Plasticity~     Institute. The investigators hypothesize that the training will improve attention in TBI~     subjects and that the advanced imaging will show corresponding neural connectivity changes,~     as compared to matched healthy controls.~   "
113446|NCT02082496|"~     The obesity epidemic is attributable to dietary and behavioral trends acting on a person's~     genetic makeup to determine body mass and susceptibility to obesity-related diseases.~     Furthermore, common forms of obesity have a strong hereditary component and many genetic~     pathways that contribute to obesity have already ben identified.~      Glucagon-like peptide-1 (GLP-1) is an incretin hormone that potentiates glucose-stimulated~     insulin secretion. However, GLP-1 also acts as an appetite-inhibiting hormone affecting the~     appetite center in the hypothalamus. Today, GLP-1 receptor agonists are available for the~     treatment of type 2 diabetes, and their treatment potential in obesity is an area of active~     research.~      The aim of this study is to explore if the appetite inhibiting effect of GLP-1 is intact in~     people diagnosed with obesity causing genetic disorders and to investigate the physiological~     role of GLP-1 on food intake and appetite regulation in this group.~   "
113447|NCT02082483|"~     Kidney transplant candidates are at very high risk for coronary artery disease (CAD). The~     optimal strategy to monitor and maintain the cardiac fitness of patients awaiting kidney~     transplantation is unknown. Currently patients undergo annual testing; however, screening for~     CAD may increase morbidity and mortality by:~        1. exposing patients to the risk of angiography and revascularization procedures~        2. delaying or excluding patients from life saving transplantation.~      Before proceeding with a definitive study to determine whether screening is necessary,~     feasibility will be determined in this pilot study.~   "
113448|NCT02082470|"~     This pilot clinical trial studies survivorship care planning in supporting quality of life in~     ovarian cancer survivors following primary treatment. Survivorship care plans have the~     potential to empower patients and provide them with a plan of care following treatments.~     Survivorship care planning may support patient's overall well-being and quality of life after~     treatment of ovarian cancer.~   "
113449|NCT02082457|"~     This trial is to investigate efficacy and safety of YKP10811 in Subjects With Irritable Bowel~     Syndrome With Constipation. The difference of responder rate between test group (10, 20 and~     40mg) and placebo will be evaluated.~   "
113450|NCT02082444|"~     Major aim of the Cognition Intervention Study Dortmund (CogniDo) was to add scientifically~     proven insights into cognitive effects of lunch to the existing recommendations for school~     meals in Germany. The Cognition Intervention Study Dortmund PLUS ties up to that aim. As an~     enhancement of CogniDo this study investigates the short-term effects of having school lunch~     versus skipping it on children's executive cognitive functions in the afternoon. The study~     was conducted in a comprehensive school in Gelsenkirchen (Germany) and included 215 children.~   "
113451|NCT02082431|"~     The purpose of this study is to determine the true incidence of long QT (LQT) amongst a large~     cohort of subjects diagnosed with unilateral (right/left) or bilateral sensorineural hearing~     loss.~   "
113460|NCT02082314|"~     Bone metastases are a cause of significant morbidity in cancer patients. In patients who die~     from breast, prostate, and lung cancer, autopsy studies have shown that up to 85% have~     evidence of bone metastases at the time of death (1). These metastases frequently give rise~     to complications that reduce patients' quality of life. These include: pain, fractures, and~     decreased mobility, ultimately reducing performance status.~      Radiofrequency ablation therapy with cementoplasty/vertebroplasty for painful bone metastases~     has been shown to be feasible, efficacious, and safe. However, patient reported outcomes have~     yet to be determined.~   "
130117|NCT01864239|"~     The purpose of this study is to find out whether talking to a pharmacist on the telephone can~     help to support people taking medicine for a long-term condition.~   "
113452|NCT02082418|"~     Aging modifies the metabolic pathway of the neurotransmitter serotonin by reducing the~     synthesis rate and increasing the breakdown rate of serotonin, possibly related to the~     observed enhanced sensitivity of the serotonergic pathway. Since serotonin plays a prominent~     role in neuropsychological functions such as anxiety, mood and memory, the enhanced~     sensitivity of the serotonergic pathway in aging can probably explain the fact that elderly~     are more vulnerable to develop cognitive deficits and depressive symptoms.~      Serotonin synthesis in brain is regulated by its precursor tryptophan (TRP). Because~     tryptophan is an essential amino acid, modifying the availability of tryptophan through~     dietary intake, can directly influence central serotonin metabolism and consequently~     affective and cognitive processes.~      The aim of this study is to test the hypothesis that an acute intake of whey protein with~     high levels of TRP such as alpha-lactalbumin can stabilize the metabolism of serotonin and~     subsequently enhance metabolic and cognitive functions in healthy older adults. The acute~     effects of this dietary protein will be investigated in subjects with mild cognitive~     impairment (MCI), or dementia, compared to control subjects in order to examine whether~     healthy older subject with MCI benefit more from the intake of alpha-lactalbumin and/or whey.~     The investigators will investigate if this meal can optimize serotonin metabolism by~     elevating plasma TRP levels and plasma TRP appearance and enhance splanchnic TRP extraction.~     In addition, the effects on mood and cognitive functions will be examined.~   "
113453|NCT02082405|"~     This phase II trial studies the side effects and how well lower doses of bortezomib,~     dexamethasone, and cyclophosphamide work in treating older patients with multiple myeloma.~     Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for~     cell growth. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Giving cyclophosphamide daily may kill more cancer cells. Giving~     bortezomib, cyclophosphamide, and dexamethasone may be an effective treatment for multiple~     myeloma.~   "
113454|NCT02082392|"~     The goal of this study is to develop new methods of administering antidepressant medications~     that will result in improved drug/placebo separation in randomized controlled trials (RCTs)~     for Major Depressive Disorder (MDD) and enhanced medication response in open clinical~     treatment. The highly intensive, weekly visit schedule followed in most antidepressant RCTs~     radically differs from how antidepressant medications are prescribed in standard clinical~     practice and is believed to be a major reason why the majority of studies submitted to the~     Food and Drug Administration (FDA) fail to show a significant difference between medication~     and placebo. Moreover, a one size fits all approach to psychopharmacologic management~     (i.e., weekly visits for all patients) does not take into account differences between~     patients that may predispose some individuals to respond positively to frequent follow-up~     visits, while others may respond negatively or not at all. Clinic visits comprise multiple~     components that may be therapeutic for depression, including activating patients' behavior,~     exposing them to medical procedures, permitting social interactions with research staff, and~     providing supportive meetings with clinicians. Two independent meta-analyses have associated~     more frequent study visits with increased antidepressant and placebo response as well as~     decreased separation between medication and placebo. Despite the high costs and potential~     disadvantages of weekly follow-up visits for patients receiving antidepressant medication,~     this clinical management strategy has not been studied prospectively to date. It is unknown~     whether weekly follow-up visits are needed to ensure treatment compliance and patient safety~     in clinical trials and to what degree contacts with clinicians influence medication and~     placebo response.~   "
113455|NCT02082379|"~     We hypothesize that infant and children will show different levels of acceptance of different~     interfaces while they receive inhaled therapy.~      We also hypothesize that children will exhibit different amounts of time with the aerosol~     well aligned with the nostrils during transnasal aerosol delivery.~   "
113456|NCT02082366|"~     The aim of the investigators study is to analyze the incidence of MES by TCD performed during~     AF ablation with the nMARQ and to compare is with the incidence of MES using a conventional~     irrigated ablation catheter. Objective: To investigate the incidence of MES on TCD during AF~     ablation with the nMARQ catheter compared to a conventional irrigated ablation catheter.~     Following inclusion, patients will be randomized into 2 equal different treatment groups: PVI~     with traditional irrigated RF catheter versus PVI using the nMARQ catheter. In all patients,~     anticoagulation therapy with warfarin is discontinued five-days before the procedure and low~     molecular weight heparin is initiated at that time. A CT-scan of the left atrium is performed~     and imported into the Carto 3 mapping system. The ablation procedure is conducted under~     general anesthesia or conscious sedation. A decapolar catheter is positioned in the coronary~     sinus and a quadripolar catheter is positioned at the His bundle level through the right~     femoral vein. Two 8F sheaths are introduced into the left atrium with double trans-septal~     puncture performed under fluoroscopic, trans-esophageal echocardiographic or intracardiac~     echocardiography guidance. Upon completion of the first trans-septal puncture, intravenous~     heparin is administered to maintain an activated clotting time of 350 seconds throughout the~     procedure. A variable Lasso circular mapping catheter is introduced through the SL1 sheath~     into each pulmonary vein for electrical mapping. After the second trans-septal puncture, a~     Navistar Thermocool 3.5mm irrigated ablation catheter or an nMARQ circular irrigated ablation~     catheter are introduced into the left atrium. Of note, in case of use the nMARQ catheter, the~     second SL-1 sheath is replaced by a steerable 8F agilis sheath after the second trans-septal~     puncture. Each of the 4 PVs are imaged by selective angiograms. The left atrium geometry is~     created using the nMARQ catheter or the Navistar catheter and then merged with the~     pre-acquired CT scan of the left atrium and PVs. Identiﬁcation of true MESs will be possible~     using an event detector system, in addition to determining whether the MESs are attributed to~     a solid or to a gaseous embolus. Total MES counts will be collected and evaluated separately~     during different stages of the procedure.~   "
113457|NCT02082353|"~     Chronic granulomatous disease (CGD) is an inherited immune system abnormality in which bone~     marrow transplantation (BMT) has been shown to be curative. However the risks of~     transplantation are high and not all patients with CGD may need to undergo this high risk~     procedure. This study will determine the long term medical condition and daily functioning of~     participants with CGD after a transplant and if possible, compare these results to~     participants who do not undergo a transplant.~   "
113458|NCT02082340|"~     Randomized trial tests effectiveness of self-administered drug intake by empowered TB~     patients - supervised by a trained family member and supported by medical counseling and~     reminders - to improve treatment adherence and treatment success rates, and thereby forestall~     TB and MDR-TB epidemics.~   "
113459|NCT02082327|"~     The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of IV~     migalastat HCl alone and to determine absolute bioavailability for oral migalastat HCl as~     compared to IV administered migalastat HCl in healthy volunteers. The data from this study~     will help us understand how migalastat works in the body and will help us determine what~     would be an effective dose in future studies with migalastat hydrochloride.~   "
113463|NCT02082275|"~     The study defines a new model of prenatal care called OB Nest which will be compared to the~     traditional model of prenatal care. OB nest is intended to create an experience for patients~     that feels more connected and patient-centered, allowing the patient to visit the clinic less~     frequently while offering increased communication with the OB nurses and providers through~     new tools provided to the patient. The goal of the project is to promote patient-centered~     care through a new prenatal care program based on constant and direct support from a nursing~     team, meeting the on-demand needs of expecting mothers as they rise, and as thus, redesigning~     the need and timing of on-site appointment with providers. Pregnant women randomized to the~     OB Nest cohort will see the number of pre-planned visits with their providers decreased and~     replaced with more direct and constant support and interaction with an assigned nursing team.~   "
113464|NCT02082262|"~     This study will evaluate the safety and efficacy of AGN-229666 for the treatment of seasonal~     or perennial allergic conjunctivitis.~   "
113465|NCT02082249|"~     This is an extension study to evaluate the long-term safety and tolerability of ABT-SLV187 in~     subjects with advanced Parkinson's disease.~   "
113466|NCT02082236|"~     The purpose of this study is to establish the single and multiple-dose pharmacokinetics (PK)~     of sublingual administration of the Sufentanil Sublingual Microtablet (SSM) 30 mcg and~     compare the pharmacokinetics of a single dose of SSM 30 mcg to 2 doses of SSM 15 mcg~     administered 20 minutes apart.~   "
113467|NCT02082223|"~     A pilot to test feasibility of improving patient/caretaker quality of life and resilience.~   "
113468|NCT02082210|"~     The purpose of this study is to find a recommended schedule and dose range for LY2875358 when~     given with ramucirumab that may be safely given to participants with cancer. In Part A of~     this study, escalating doses of LY2875358 will be given in combination with a fixed dose of~     ramucirumab to evaluate the safety of the combination. After a recommended schedule and dose~     range of LY2875358 and ramucirumab has been established, Part B of the study will confirm~     safety and to see how well certain tumors respond to the combination of study drugs. The~     average amount of time on study is expected to be about 6 months.~   "
113469|NCT02082197|"~     This is an open-study with a 26 week open label treatment period followed by an optional 26~     week open label extension. The total treatment period will be 52 weeks.~   "
113470|NCT02082184|"~     To evaluate the impact of the Abbott Sensor Based Glucose Monitoring System on glycaemic~     control (HbA1c) compared to Self Monitoring Blood Glucose (SMBG) testing using a randomised~     controlled study design in adults with Type 2 diabetes using insulin.~   "
113471|NCT02082171|"~     Prevention of physical disability represents a major priority for the public health system.~     Physical disability is the final result of a complex cascade of negative events occurring at~     different levels (i.e., environmental, social, biological, and clinical). The heterogeneity~     of the underlying mechanisms responsible for the onset of physical disability may require the~     adoption of preventive interventions affecting multiple domains. Although several studies~     suggest that single or different combinations of preventive interventions (in particular,~     physical activity, cognitive training, and healthy diet) might provide beneficial effects in~     preventing functional loss (and its related features, such as pain or reduced quality of~     life), very limited evidence coming from clinical trials is currently available on the topic.~     Intervention trials are usually designed to test the effect of a specific monodimensional~     intervention on a very selected population, so to reduce the risk of biased results. This~     approach, although legitimate and methodologically correct, may 1) be insufficient to target~     the multiple and heterogeneous physiopathological mechanisms underlying the onset of physical~     disability, and 2) cause a population selection bias leading to difficulties in implementing~     the study results to the overall older population (thus, determining the evidence-based~     medicine issue in the elderly). To our knowledge, there are no available data from clinical~     trials evaluating the effects of a multidomain intervention based on lifestyle modifications~     (e.g., physical activity, cognitive training, nutritional modification) for preventing~     mobility disability (a very early phase of the disabling process) in community-dwelling older~     persons. In the present project (Multidomain Intervention to preveNt Disability in ElDers,~     MINDED), we propose to conduct a pilot study aimed at estimating the effects of a multidomain~     person-tailored preventive intervention (based on physical activity, cognitive training, and~     nutritional modifications) on frailty status, physical performance, cognitive function,~     nutritional status, health-related quality of life, and use of health care services. In~     addition, we will perform cost-effectiveness analyses of the proposed intervention. The~     project will yield the necessary preliminary data to design a definitive full-scale Phase 3~     randomized clinical trial. By providing a conclusive answer about the effectiveness of a~     multidimensional preventive program in the primary prevention of major health-related~     outcomes, the results of the full-scale trial will have relevant clinical and public health~     implications, and will promote the practicing of a truly evidence-based geriatric medicine.~   "
113472|NCT02082158|"~     This VA-based study will obtain feedback from healthcare workers via validated survey~     instrument on the comfort and tolerability of wearing current models of N95 respirators and~     novel respirator designs currently in development. There will be 4 novel respirators and 1~     commonly used respirator (not locally used) to compare to a locally used respirator, which is~     familiar to participants. Comparisons will be examined between each of the first 5 models~     with the locally used control using Dunnett's t-test.~   "
113473|NCT02082145|"~     To assess the effect of the device on the progression of diabetic peripheral neuropathy~   "
113474|NCT02082132|"~     The purpose of this study is to describe and compare the different types of diabetes that~     exist in people from white European and south Asian origin in the UK (United Kingdom) who are~     diagnosed with diabetes before they turn 30 years old. By doing this we hope to identify~     cases of MODY (maturity onset diabetes of the young), which is a rare genetic cause of~     diabetes that is frequently misdiagnosed. Identifying MODY cases is important, as the~     treatment may differ to conventional treatment for type 1 or type 2 diabetes.~   "
113475|NCT02082119|"~     To evaluate safety and feasibility of hypofractionated IMRT in addition to chemotherapy,~     concomitant and adjuvant, in patients with newly diagnosed HGGs after surgery.~      Primary endpoint: progression free survival (PFS), Overall Survival (OS) and Toxicity.~      Secondary endpoint: to evaluate Quality of life (QoL) of patients after surgery, concomitant~     chemoradiotherapy and adjuvant chemotherapy through neuropsychological examination.~   "
113485|NCT02081989|"~     Renal denervation (the use of radio waves to oblate the renal artery) has been shown to be an~     effective treatment for high blood pressure. It is currently being tested in heart failure~     patients and we would now like to look it its effects on diabetes.~      We therefore plan to enrol 20 participants with type II diabetes into this study. Half will~     undergo renal denervation in addition to their standard care and the other half will act as~     controls and only receive standard care. Treatment allocation will be randomly assigned.~      All participants will undergo screening (including a physical exam, blood tests, ultrasounds~     and a muscle biopsy). All patients will have follow up tests (including physical exams and~     blood tests) 1, 3 and 6 months later.~   "
113796|NCT02077946|"~     This trial is conducted in Europe. The aim of this study is to investigate a retrospective~     database assessment of clinical effectiveness in type 2 diabetes patients treated with~     liraglutide from primary care centers in Sweden.~   "
113476|NCT02082106|"~     Problem description In industrialized countries there is a rapid increase in the number of~     senior citizens. In Austria more than 50% of the population is overweight, with highest~     prevalence in the age group from 60 to 74 yrs and the WHO lists physical inactivity as one of~     the main behavioral risk factors of cardiovascular diseases.~      Especially in winter months, activity related energy expenditure was 40% and 31% lower in the~     US and Canada, respectively. In addition, in an Austrian study the winter season was~     associated with higher blood pressure, total cholesterol and body mass index, giving an~     increasing risk of chronic coronary disease by 6.8% in men and 3.6% in women.~      Therefore, the development of intervention programs that overcome the winter physical~     activity deficit and be feasible also for elderly should be goal of future research. Alpine~     skiing (AS) and cross country skiing (XCS) have a long standing tradition in Austria and~     could potentially fill the winter physical activity gap. The Salzburg Skiing for the Elderly~     Study (SASES) has found AS to be a save and feasible possibility to improve the health of the~     aged population in many parameters. XCS as a competitive sport is already well explored but~     there are hardly any studies about its effects in the normal or elderly population.~     Unfortunately knowledge about the differences between AS and XCS in the physiological~     adaptation processes in the elderly population is also lacking.~      Aims and hypotheses of the pre-study In order to standardize training interventions, the~     present pre-study aims at comparing physiological and metabolic parameters between AS, XCS~     and IT. Therefore, the results of the pre-study serve as determinants for the training~     parameters of the above mentioned main study.~      We postulate that, based on the results of the present study, it is possible to set up~     comparable isocaloric training sessions for AS, XCS and IT for elderly and unfit persons.~      Furthermore, we assume that elderly and unfit subjects are able to perform a full spectrum of~     intensities and techniques necessary to set appropriate stimuli for isocaloric comparison.~      We hypothesize arterial stiffness indices and circulating microRNA (miRNA) patterns to change~     due to one bout of physical activity of AS, XCS, and IT with variations depending on the kind~     of sport.~   "
113477|NCT02082093|"~     The main objective of this study is to demonstrate the efficiency ( cost-effectiveness ) of a~     telemedicine system : eNephro Application , compared with traditional care in the management~     of chronic renal failure in different populations :~        -  population 1 : Patients with CKD stage 3B- 4 , the combined endpoint achievement of~          target blood pressure and proteinuria .~        -  population 2 : Patients with ESRD treated by ambulatory dialysis , the cumulative~          duration of hospitalization in short-stay~        -  population 3 : Patients with ESRD treated with Renal Transplantation , the cumulative~          duration of unplanned short stay~      Two statistical analysis will be done :~        -  a main analysis for the one year initial follow-up for each patient~        -  a secondary analysis for the one year initial follow-up estended by one year (proposed~          to each patient at the end of the initial follow-up), that is a 2 years period.~      The intervention tested in this study is a telemedicine system which is a collaborative and~     expert system, consisting of:~        -  A dynamic shared medical record for the collection of administrative , medical,~          biological and clinical data for each patient. All health professionals can access the~          folder and fill in the support. It is the same for patients treated at home.~        -  A secure messaging for communication between health professionals and between patients~          and health professionals~        -  Expert systems analyzing data from each patient~        -  A management tool of therapeutic education~      Each patient and whatever the group will perform as part of its monitoring of the CKD~     assessments at baseline , 6 months, 12 months, 18 months (Populations 1 and 2) and end of~     study (24 months). These evaluations are about compliance, quality of life, anxiety -~     depression state. To enhance costs the point of view retained will be health insurance's~     point of view. Among the various costs, only direct costs are considered: disease management,~     hospitalizations, consultations in hospitals and private practice, prescribed medical~     transportation , home visits by health professionals, additional assessments related to the~     evaluated intervention. A probabilistic matching with the data bases of the National~     Information System of the Social Insurance will be performed. In addition, the acceptability~     of the system of telemedicine by patients in the intervention and health professionals will~     be also evaluated.~   "
113478|NCT02082080|"~     This study evaluates the effect of an interventional model for preventing and controlling~     overweight and obesity in male and female fifth-graders. First, based on WHO (World Health~     Organization) references obese (BMI-Z score ≥ 2) and overweight (BMI-Z score ≥ 1) students~     from 12 primary schools (randomly allocated to 6 intervention and 6 comparison) will be~     screened. Then from the screened students 30 students with the following inclusion criteria~     will be recruited: not metabolically ill, not on a weight losing diet and not professionally~     athlete. For selected students BMI-Z score as primary outcome will be calculated. Demographic~     data, as well as data on waist and hip circumference, triceps skin-fold thickness, food~     intake for 3 days (2 ordinary week days and 1 weekend) and physical activity will be~     collected at the beginning and at end of the 6-month intervention. The approach of the study~     will be Health Promoting Schools. The intervention includes three components, i.e., nutrition~     education (students and parents), increased physical activity, and changing environment (food~     items offered in schools' canteens). Nutrition education will be imparted (a 30-minute~     session per week) by health instructors; physical activity will be done under the supervision~     of the school coaches (2 one-hour sessions per week). Parents' education (a 1.5-hour session)~     will be monthly. Finally the efficacy of the intervention will be determined and reported.~   "
113479|NCT02082067|"~     Aim of this study is to evaluate the effects of the adductor canal block on the early and~     medium term ( 1 month) rehabilitation compared to the continuous femoral block commonly used~     in the knee prosthesis.~   "
113480|NCT02082054|"~     This active vs active comparative trial will evaluate the safety and efficacy of incremental~     doses of atropine in combination with pseudoephedrine 120 mg/chlorpheniramine 8 mg in adult~     patients with a history of seasonal allergic rhinitis. Hypotheses are defined by total nasal~     symptom scores (TNSS) recorded by subjects in diaries where efficacy will be established by~     statistical significance where p < 0.05.~   "
113481|NCT02082041|"~     The purpose of this study is to monitor the skin blood flow in the lower leg, with different~     levels and types of applied loads. These loads will not be placed over the patient's wound~     nor will they be higher than loads the skin normally experiences in daily activities. The~     results of this research will help investigators understand the development of pressure~     ulcers, commonly known as bedsores and stasis ulcers.~   "
113482|NCT02082028|"~     To demonstrate the superiority of a chronic care model (SINERGIA model) supported by the Self~     Monitoring of Blood Glucose with BGStar over usual care in improving glycemic control at 12~     months in patients with type 2 diabetes not treated with insulin.~   "
113483|NCT02082015|"~     The purpose of this study is to Evaluate Efficacy and Safety of rTMS 『TMS』 for Upper~     Extremity Motor Function Recovery in Patients with Ischemic Stroke~   "
113484|NCT02082002|"~     Fatigue is a common symptom in patients with multiple sclerosis, however, its nature is not~     completely understood. Fatigue overlaps often with other symptoms such as somnolence,~     depression and cognitive disorders, from which it is not always readily distinguished. The~     evaluation of fatigue and the three most frequently associated symptoms using a~     multidimensional approach might allow to understand, which methodology is the best indicated~     to estimate the prevalence of fatigue with greatest accuracy, leading to a better~     differentiation of the symptoms in the diagnostic setting.~   "
113499|NCT02081807|"~     This cohort study is the sequential expansion of the comparative effectiveness study of oral~     anticoagulants and plans to identify initiators of oral anticoagulants using electronic~     claims data from a commercial insurance database to quantify associations between~     anticoagulant choice (warfarin and dabigatran) and the occurrence of selected outcomes in~     patients with non-valvular atrial fibrillation at risk for stroke.~   "
113486|NCT02081976|"~     Cardiovascular diseases (CVD) are still considered the main cause of mortality and morbidity~     all over the world. In the last years, efforts have been made to define more effective~     therapeutic and preventive strategies.Periodontal diseases have been considered a probable~     risk factor for CVD with a great amount of evidence from observational studies. Although~     there are some interventional studies evaluating the systemic effects of periodontal therapy,~     there is little information regarding the impact of periodontal treatment on the prevention~     of cardiovascular events. To the best of our knowledge, there are no randomized controlled~     trials published to date assessing the effect of periodontal therapy in primary prevention of~     CVD.~   "
113487|NCT02081963|"~     This is a multi-centered, randomized, controlled study to assess the efficacy, indications~     and adverse reactions of combined administration of nebulized amikacin in patients with acute~     exacerbation of non-cystic fibrosis bronchiectasis and to evaluate whether inhaled~     antibiotics are more likely to cause bacterial resistance.~   "
113488|NCT02081950|"~     This is a pilot, open-label study aimed at a preliminary evaluation of enoxaparin~     bioavailability following two administrations of Clexane s.c. at a dose of 80mg, in two~     different periods.~   "
113489|NCT02081937|"~     Patients receive anti-CD19-CAR (coupled with CD137 and CD3 zeta signalling~     domains)vector-transduced autologous T cells over a period of 4 or 5 consecutive days in an~     escalating dose. After completion of study treatment, patients are followed intensively for 6~     months, every 3 months for 2 years, and annually thereafter for 10 years.~   "
113490|NCT02081924|"~     The purpose of this study is to determine the physiological effects of sustained~     administration of the natural hormone kisspeptin on reproductive function in participants~     with reduced fertility. Kisspeptin is a recently identified natural hormone which is~     regulates human reproduction. Learning more about the physiological role of kisspeptins may~     therefore give us a better understanding about human fertility, and improve the management of~     patients with reduced fertility. The effects of sustained administration of kisspeptin on~     hypothalamic reproductive function (i.e. Luteinising hormone pulsatility) are not known.~   "
113491|NCT02081911|"~     The purpose of this study is to investigate whether there is quantitative motor-sparing of~     the quadriceps muscles following adductor canal nerve block versus femoral nerve block.~     Patients will be randomly placed into one of three treatment groups: 1) Femoral nerve block,~     2) Adductor canal nerve block - low volume, or 3) Adductor canal nerve block - high volume.~     Quadriceps function will be assessed in the operating room using a skin patch and electrical~     stimulation. Follow up visits with the patients will continue over the course of 2 days~     during patient's stay at the hospital. A total of 60 patients will be enrolled for the study.~   "
113492|NCT02081898|"~     The effect of weight loss with long-term low calorie diet (LCD) on plasma metabolites is~     unknown. The aim was to examine whether a LCD-induced weight reduction results in changes in~     the extended plasma metabolites.~   "
113493|NCT02081885|"~     Introduction After a mandibular fracture where bone has been lost, a number of complications~     and challenges are presented in trying to solve them. These defects are mainly classified~     into two groups: functional and cosmetic. The functional defects are incompetence of the~     lower lip, salivary incontinence, severe difficulty chewing and swallowing, temporomandibular~     joint disorders and difficulty in pronouncing words.~      Esthetically facial asymmetry is produced with collapse of the affected side. Unreconstructed~     jaw retrusion and tends to offset the affected side, there is a change in mandibular~     movements, which, previous vertical movements are replaced by oblique or diagonal movements~     controlled by a single temporomandibular joint. It also presents a limitation in motility and~     lingual force, besides proprioception disorder left by the inferior alveolar nerve The loss~     of bone in mandibular fractures, is one of the great challenges facing maxillofacial surgery~     and unfortunately increasingly common. That's why they have done and are still doing research~     for the development of biomaterials, all with the purpose of trying to solve this problem by~     offering the patient better results than those obtained in the past, restoring both function~     and facial aesthetics according to each case~   "
113494|NCT02081872|"~     UPGRADE aims to see whether data from Pharmacogenomic Testing (PGx) can help physicians~     manage patient medication regimens and assess if the testing has an effect on reducing~     adverse drug reactions, hospitalizations and emergency department visits.~      The way an individual processes a drug is in part determined by their genes, and there is~     known to be genetic variation between humans in the way drugs are metabolized. The study of~     the way genes affect a person's response to drugs is known as Pharmacogenomics.~   "
113495|NCT02081859|"~     This is a randomized controlled observational trial to determine if data obtained from the~     embryoscope is helpful in determining which blastocysts to transfer.~   "
113496|NCT02081846|"~     Home Nurse Visit post discharge.~   "
113497|NCT02081833|"~     This study serves as a feasibility study for a birth cohort study to investigate the~     influence of the sequence and load of infections and vaccinations on the development of the~     immune system of children. In this study, the investigators aim to test the methods developed~     to capture acute respiratory and gastrointestinal infections and their consequences of~     children aged 1 to 3 years in Braunschweig, Germany. Furthermore, the investigators want to~     study the influence of the environment on the microbiome of children by comparing children of~     the same child care centre with children from different child care centres. The methods~     developed include a symptom diary which has to be filled out on a daily basis by the parents.~     Furthermore parents are asked to take monthly anterior nasal swabs and stool samples from the~     study child independent from symptoms as well as one sample if symptoms occur. The parents~     are provided with instructions and the first nasal swab will be demonstrated by trained study~     personal. The study is powered to compare nasal swabs taken by the trained staff and the~     parents as primary outcome. Secondary outcome is the performance of reminders sent to the~     study participants. The diary and the specimen will be mailed to the Helmholtz Centre for~     Infection Research where they will be analyzed for the nasal and gut microbiome. The nasal~     swabs taken at the time of an infection will be tested for respiratory viruses. After the~     study period of 3 months parents will be asked about the feasibility and acceptance of the~     symptom diary and taking the nasal swabs and stool specimens by means of questionnaires and~     interviews (face to face and focus groups). This will help our understanding of the~     feasibility and acceptance of the methods developed to capture acute respiratory and~     gastrointestinal infections of children and our understanding of the development and~     composition of the nasal and gut microbiota.~   "
113498|NCT02081820|"~     In patients suffering from aneurysmal subarachnoid hemorrhage (aSAH), hyperglycemia is~     considered an adverse prognostic factor. Glycated hemoglobin (or HbA1c) can be measured to~     estimate the average plasma glucose concentration over prolonged periods of time, thus~     determination of glycated hemoglobin at admission after aSAH serves as an approximation of~     blood glucose levels in the weeks preceding aneurysm rupture. In this patient registry~     admission HbA1c, clinical course and neurological outcome after 6 month are recorded, to~     determine whether elevated blood glucose levels prior to aneurysm rupture influence the~     clinical course and patient outcome after aSAH.~   "
113500|NCT02081794|"~     This randomized pilot clinical trial studies tailored patient educational intervention or~     standard education in assessing perceived risk for falls in hospitalized oncology patients. A~     tailored patient educational intervention may be more beneficial than standard education in~     preventing patients from falling by increasing the patient's knowledge of the risk factors~     for falling routinely and then providing education in deficit areas. Making patients more~     aware of the risk factors for falling may lead to greater engagement in preventative~     activities.~   "
113501|NCT02081781|"~     The purpose of this study was to investigate various potential factors that affected the~     outcome of treatment of congenital nasolacrimal duct obstruction.~   "
113502|NCT02081768|"~     There is no consensus in the literature on the best way to treat cystic lesions of the~     pituitary area. Patients who are symptomatic from these tumours are rare. The cystic form of~     tumours present special challenges since traditional treatment modalities (surgery and/or~     external radiation) are often not able to completely remove or treat the cyst wall without~     major morbidity or even mortality.~      There is no 'best practice' for the treatment of cystic tumours per se. Treatments available~     to patients with cystic sellar/parasellar tumours include conservative management using a~     'wait and scan' approach, cyst drainage, and cyst removal via transsphenoidal and/or~     craniotomy approach (i.e. open surgery). Over the last 10 years we have treated approximately~     8 patients with intracystic radiotherapy. All of these patients continue to be monitored~     clinically and radiologically and all have done well with stable regression of the cysts and~     no new neurological deficits. Over the past 2 years, 90yttrium colloid has been provided to~     CDHA through Health Canada's Special Access Program (SAP). It has only been of recent that~     Health Canada has requested a clinical trial to assess the benefit of intracystic~     radiotherapy over other available treatment options.~      The experimental treatment being proposed is the stereotactic intracavitary instillation of~     90yttrium colloid for treatment of cystic lesions of the pituitary (sellar) and surrounding~     areas (parasellar).~   "
113503|NCT02081755|"~     This study is a prospective Phase IV study to determine if the use of Everolimus results in~     lower liver tumor recurrence and improved patient and graft survival after liver transplant~     for hepatocellular carcinoma (HCC). The immunosuppressive comparators will be Everolimus and~     Tacrolimus therapy compared to Tacrolimus and Mycophenolic acid/Mycophenolate Mofetil.~     Primary outcomes data is disease free survival (the time from randomization to HCC recurrence~     or death). Secondary outcomes are rate of recurrence of Hepatitis C, problems related to~     wound healing, hernia repair within the first 12 months, hepatic arterial thrombosis, renal~     function, acute cellular rejection, post-transplant diabetes, hypertension, and~     hyperlipidemia.~   "
113504|NCT02081742|"~     Summary Colorectal cancer (CRC) represents the second leading cause of cancer deaths in Spain~     (11,000 deaths per year). Screening of the population over 50 years of age with no~     significant history (intermediate risk) is recommended, but which screening method is best~     for promoting adherence in this type of patient has not been well established. There are~     currently two screening methods that are less invasive than conventional colonoscopy and seem~     to have higher sensitivity than the test for faecal occult blood (FOBT). These two methods~     are the colon capsule, which consists in ingesting a capsule that takes photographs of the~     colon, and virtual colonoscopy, which is a radiological technique.~      Objectives: 1. To demonstrate that virtual colonoscopy and colon capsule are effective CRC~     screening techniques in the intermediate risk population, with diagnostic rates comparable to~     conventional colonoscopy (concordance). 2. To compare the diagnostic rates of the colon~     capsule and virtual colonoscopy with respect to the size and characteristics of the lesions~     visualised. 3. To compare the participation rates for each screening strategy and identify~     the factors that influence participation (individual, family, and socioeconomic factors as~     well as those relating to the doctor).~   "
113505|NCT02081729|"~     VZV is one of the important opportunistic infection in transplant recipients.Until now, there~     is no laboratory method to stratify the risk of VZV reactivation after solid organ~     transplantation. Theoretically, VZV-specific cell-mediate immune response before solid organ~     transplantation will further categorize the patients into high or low risk of VZV development~     after solid organ transplantation. The investigators thus evaluate the usefulness of~     VZV-specific ELISPOT assay in kidney transplant candidates to predict the development of VZV~     infection after kidney transplantation.~   "
113506|NCT02081716|"~     CMV is one of the most important opportunistic infection in transplant recipients. In South~     Korea, more than 95% of adults reveal sero-positivity for CMV IgG. Until now, sero-positivity~     for CMV IgG before bone marrow organ transplantation is a laboratory test of choice to~     stratify the risk of CMV reactivation after solid organ transplantation. Theoretically,~     CMV-specific cell-mediate immune response before and after bone marrow transplantation will~     further categorize the patients into high or low risk of CMV development after bone marrow~     transplantation. The investigators thus evaluate the usefulness of CMV-specific ELISPOT assay~     in bone marrow transplant candidates to predict the development of CMV infection after~     transplantation.~   "
113507|NCT02081703|"~     The objectives of this study are to evaluate the safety and analgesic efficacy of a single~     preoperative intrathecal administration of AYX1 Injection at two dose/volume levels.~   "
113508|NCT02081690|"~     Prospective, multi-center, open-label, single-arm, Phase 3b psychometric validation study.~      Primary objectives: To evaluate the psychometric characteristics of reliability and construct~     validity of the French, Italian and Spanish versions of the PAH-SYMPACT™.~      To evaluate the ability of the French, Italian and Spanish versions of the PAH SYMPACT™ to~     detect change.~      Secondary objective: To assess the safety of macitentan in patients with pulmonary arterial~     hypertension (PAH).~      Exploratory objective: To explore the effects of macitentan on PAH symptoms and their impact~     (as measured by the PAH-SYMPACT™) in patients with PAH in France, Italy and Spain.~   "
113509|NCT02081677|"~     There will be four study lenses tested; one marketed lens, and three prototype study lenses.~     Subjects will be randomized to one of the four study lenses which will be worn in a daily~     wear modality, with a two week replacement.~   "
113797|NCT02077933|"~     Dose escalation part: to determine the highest dose of alpelisib administered on a daily~     basis when given in combination with daily everolimus or in combination with daily everolimus~     and exemestane.~      Dose expansion part: To describe safety and tolerability of the alpelisib and everolimus or~     alpelisib, everolimus and exemestane combinations.~   "
113510|NCT02081664|"~     Some patients report relief of symptoms after amalgam removal. However, a large group of~     patients are still suffering from partly severe health complaints even after the removal of~     amalgam. To date, no biological/medical explanation for these Amalgam attributed health~     complaints is available.~      The objective of this study is to develop an integrated medical care rehabilitation program~     and determine if it is a valid and feasible treatment for patients with persistent symptoms~     after amalgam removal. Such a comprehensive concept has to date not been operationalized in~     Norway, but information about the feasibility and the challenges around such a rehabilitation~     program are required, in order to prepare for a possible controlled and randomized study~     evaluating the effects of the suggested integrative care treatment program. This treatment~     program will focus on learning by practicing, hence the study participants will be enrolled~     into a group program focusing on life-style changes. In addition to the life-style oriented~     group program, an individualized treatment strategy with therapies out of the spectrum of~     Complementary and Alternative Medicine (CAM) will be part of the treatment program. This part~     of the program is based on the results of a survey, related to use of CAM therapies,~     conducted in 2012 among the members of the patient organization Forbundet Tenner og Helse.~      Participants of this treatment program must amongst other inclusion criteria have removed all~     dental amalgam fillings and experience symptoms which have not disappeared after removal of~     the dental fillings. Specific exclusion criteria are stated. The group program consists of 12~     sessions which are held once per week for a whole day. Added to this is a choice of CAM~     therapies from a hierarchic list, established from the survey, and which accordingly is based~     on risk/benefit judgment. Data collection will take place at baseline, after 12 weeks (end of~     treatment), and three month later. The aim of this study is to test the feasibility of an~     integrated medical care rehabilitation program for patients in Norway who have had their~     Amalgam fillings removed, but still suffer from Amalgam attributed symptoms. It combines a~     lifestyle oriented group program with individualized CAM therapies in form of an outpatient~     program.~   "
113511|NCT02081651|"~     Cow's milk allergy is the most common food allergy in children. The scenery clinical and~     epidemiological of cow's milk allergy is significantly changed in the last decade. The~     severity of the clinical manifestations is still rising, and now cow's milk allergy has~     become the leading cause of hospitalization for food -induced anaphylaxis in our country. In~     addition, the overall prevalence of cow's milk allergy is increasing for a gradual reduction~     in the ability to acquire immunological tolerance to cow's milk protein in the first years of~     life. These mutations dictate the need to identify strategies to stimulate the acquisition of~     immunological tolerance in children affected by cow's milk allergy . The mechanisms of~     acquired immunological tolerance are not yet fully defined . The current view suggests the~     existence of a dynamic mechanism , consisting of various cellular compartments , which is set~     in a crucial environmental factors arising mainly from the diet and its effects on the~     intestinal microbiota. These acquisitions have contributed to the definition of a new concept~     in the field of human nutrition: immunonutrition. The immunonutrition is the ability, through~     the intake of specific nutrients on the immune system to interfere directly or indirectly~     through modulation of the composition and function of the intestinal microbiota. The~     proponent group has recently shown that it is possible to stimulate a more rapid acquisition~     of immunological tolerance in children affected by CMA through the administration of~     extensively hydrolysed casein containing the probiotic Lactobacillus rhamnosus GG (LGG)~     (Berni Canani et al. J Pediatr 2013) . Several lines of evidence suggest that this effect is~     induced by a combination of direct immunomodulatory action exerted by some small peptides~     derived from the beta - casein and the action of lactobacillus GG. It 's well known that the~     Lactobacillus GG is able to adjust the composition and functions of the microbiota in the~     child with CMA and directly adjust some immunological mechanisms involved in the pathogenesis~     of this condition. At the same time other groups have demonstrated the possibility that a~     high percentage of patients with IgE-mediated CMA is able to tolerate foods containing~     hydrolyzed cow's milk proteins with different processes. It has also been speculated that~     these strategies can facilitate the acquisition of immune tolerance in patients with cow's~     milk allergy. One of these foods is Parmigiano -Reggiano cheese, which is characterized by an~     ' extensive hydrolysis of the proteins in cow's milk , which degrade the caseins present and~     generate large amounts of peptides and free amino acids and by the presence of appreciable~     quantities of Lactobacillus GG in the samples to maturing higher . In a recent study it was~     shown that 58% of patients suffering from IgE-mediated CMA is able to tolerate a daily intake~     of normal amounts of this food , especially in the absence of a sensibilization to IgE~     specific to the beta lactoglobulin. These new findings allow us to hypothesize the use of~     Parmigiano REggiano cheese as a possible strategy immunonutrition can stimulate the~     acquisition of immune tolerance in patients with CMA .~   "
113512|NCT02081638|"~     Background:~      - The immune system protects the body from infection. But it can also cause harm. For~     example, the clotting system makes blood clot and protects from bleeding. But blood clots are~     sometimes harmful. People with human immunodeficiency virus (HIV) infection have increased~     inflammation and clotting. This may increase their risk for diseases like stroke or heart~     attack. Researchers want to know how aspirin or HMG-CoA reductase inhibitors (so-called~     statin medications) affect the immune and clotting systems of people with HIV. Aspirin is a~     medicine to decrease clotting. Statins are medications given to lower cholesterol and~     decrease inflammation.~      Objectives:~      - To see how aspirin or statins change immune and clotting systems in people with HIV.~      Eligibility:~      - Adults 18 and older with HIV and a low viral load, not on aspirin or a statin medication.~     They must also have either: (1) never taken anti-HIV medications (ARVs), have a suppressed~     viral load, have stable CD4 counts, and never had an opportunistic infection; or (2) been~     taking ARVs for 5 continuous years and have a suppressed viral load for more than 3 years.~      Design:~        -  Participants will be screened with medical history, physical exam, and blood and lab~          tests.~        -  Participants will repeat screening tests and have an MRI. An MRI is a way to visualize~          blood vessels in the neck and head. Participants will lie on a table that slides in and~          out of a cylinder surrounded by a magnetic field.~        -  Participants will take either study drug once daily for 9 months.~        -  Participants will have a blood procedure twice. Blood will be removed through a needle~          in one arm and circulated through a machine that removes white blood cells. The blood,~          minus white blood cells, is returned through a needle in the other arm.~        -  All participants will be observed for 3 months before and after treatment.~   "
113513|NCT02081625|"~     This study is designed to assess the safety, tolerability, efficacy and pharmacokinetics (PK)~     of NS-065/NCNP-01 in subjects diagnosed with Duchenne muscular dystrophy (DMD).~   "
113514|NCT02081612|"~     This study looks at the benefit of adding acupuncture to nutrition education for weight loss~     in women with early stage breast cancer post-chemotherapy.~   "
113515|NCT02081599|"~     The purpose of this study is to evaluate the efficacy and safety of Teneligliptin in~     combination with Insulin in patients with type 2 Diabetes for 16 weeks administration and to~     evaluate the safety and efficacy of Teneligliptin in combination with Insulin with an~     extension treatment for up to 52 weeks.~   "
113516|NCT02081586|"~     This is a pilot study examining the clinical effects of a brief Cognitive Therapy phone~     approach augmented with a CBT smartphone app geared towards patients with type 2 diabetes~     patients in poor control.~   "
113517|NCT02081573|"~     Primary aim: examine feasibility and acceptability of a brief cognitive therapy protocol for~     type II diabetes administered by nurse care managers or health coaches via phone.~   "
113518|NCT02081560|"~     The blood concentration of the antibiotic colistin is determined in patients in whom kidney~     function is reduced such that a renal replacement therapy is needed.~      Hypothesis:no dose reduction is needed in patients undergoing continuous renal replacement~     therapy over 24h because colistin is sufficiently removed by this procedure.~   "
113530|NCT02081404|"~     Gastroesophageal reflux disease (GERD), a common chronic disorder in the veteran population,~     is associated with drug costs exceeding $ 10 billion/year. Only 30-40% of patients with~     reflux symptoms have erosive esophagitis. The vast majority suffers from non erosive reflux~     disease (NERD), a condition in which standard endoscopy fails to identify any mucosal breaks~     and is unable to confirm the diagnosis. Unfortunately, a gold standard for the diagnosis of~     NERD does not exist. Narrow band imaging (NBI) utilizes spectral narrow band filters~     (incorporated into standard endoscopes) and helps to see abnormal areas not identified during~     standard endoscopy. Preliminary results have shown that NBI endoscopy may represent a~     significant improvement over standard endoscopy for the diagnosis of NERD. The purpose of~     this study is to accurately diagnosis non acid reflux disease by using a blue light (also~     known as NBI)upper endoscopy technique.~   "
117156|NCT02034032|"~     The primary objective of this study is to evaluate the efficacy of Regenexx SD compared to~     Exercise Therapy at three months. Historical comparison will be made to Total Knee~     Arthroplasty for treatment of knee osteoarthritis at 1 and 2 years.~   "
113519|NCT02081547|"~     Risk of local recurrence after rectal surgery is nationally 8% after curative surgery to 5%.~     Local recurrence rate after curative surgery varies between 3-7% in the variety of regions in~     the country. It is well known that the surgical technique total mesorectal excision (TME) has~     led to improved prognosis after rectal cancer surgery. TME surgery is difficult to perform~     and different factors affect the quality of TME preparations. Injuries in mesorectal fascia~     has been reported in up to 20% of patients who underwent TME surgery and most surgeons agree~     that this may be important for recurrences. However, it is unclear to what extent a damaged~     mesorectal fascia can be related to a worsening of prognosis in patients with rectal cancer.~      Adjuvant oncological treatment in form of chemotherapy after surgery, is offers patients with~     unfavorable tumors based on the pathological examination. Patients with favorable tumors~     (less advanced) are not offered chemotherapy, even if the surgical technique was not optimal,~     ie. that there is damage in the mesorectal fascia, as evidence for this is lacking.~      The presence of intraperitoneal cancer cells (IPC) is related to histopathological tumor~     stage of colorectal cancer. Incidence of IPC of intraperitoneal tumors (rectal cancer~     patients with tumors below the peritoneal reflection) is unclear.~      Assessment of IPC status with cytology and immunohistochemistry is technically easy and could~     after TME surgery identify those patients who have an increased risk of tumor recurrence. In~     a positive IPC status, the patient would possibly benefit from either postoperative~     radiotherapy if the patient did not receive preoperative therapy, or postoperative~     oncological chemotherapy.~      Tumour cells may be lysed in sterile water, and some surgeons rinse the abdominal cavity and~     the bowel distally to the tumour. Neither rinsing the abdomen or rectum in colorectal cancer~     is routinely occurring and the clinical benefit has not been established. The value of~     rinsing the abdomen after TME-surgery could also be studied by IPC status.~      The study hypothesis is that the IPC status is dependent on the surgical quality of the~     specimen after TME-surgery in rectal cancer patients, and its presence leads to increased~     risk of local recurrence.~   "
113520|NCT02081534|"~     Randomized. double blind, placebo controlled, parallel arms dose finding study with a 4 weeks~     treatment period~   "
113521|NCT02081521|"~     Control of diarrhoeal disease requires a comprehensive package of preventive and curative~     interventions. in Zambia, the Programme for Awareness and Elimination of Diarrhoea (PAED)~     aims to reduce child deaths by combating diarrhoea in Lusaka province, Zambia. The behaviour~     change component of the PAED programme seeks to change behaviours important for diarrhoea~     prevention (handwashing with soap and exclusive breastfeeding) and improved treatment~     outcomes (use of oral rehydration solution (ORS) and zinc in home management of child~     diarrhoea).~      The study aims to evaluate the feasibility of implementing a multiple behaviour change~     community programme to tackle diarrhoeal disease in children under-five and to assess the~     impact of this programme on practice of the target behaviours by caregivers of children~     under-five. The research questions will be answered through a a two-arm cluster-randomised~     trial (eight clusters per study arm).~   "
113522|NCT02081508|"~     The purpose of this research study is to investigate whether minimizing interference improves~     memory in multiple sclerosis.~   "
113523|NCT02081495|"~     The purpose of this study is to support the qualification of a replacement manufacturing site~     for DOXIL/CAELYX.~   "
113524|NCT02081482|"~     The occipital nerve stimulation (ONS) is used to treat patients with refractory primary~     chronic headache but its mechanism of action (MoA) remains unknown. Different hypothesis have~     been suggested in particular a specific action on cerebral generators involved in different~     types of primary headaches or a non specific action on pain modulatory network.~      The aim of this study, using the chronic cluster headache as a model, is to determine the~     changes in cerebral metabolism induced by ONS to precise its MoA in the treatment of primary~     chronic headache.~   "
113525|NCT02081469|"~     To evaluate the effectiveness and safety of tenofovir for different treatment duration in~     preventing HBV relapse in patients with malignancies after receiving chemotherapy and~     off-treatment of chemotherapy.~   "
113526|NCT02081456|"~     The purpose of this study is to investigate effects of soft tissue mobilization versus~     therapeutic ultrasound in subjects with neck and arm pain who demonstrate neural mechanical~     sensitivity.~   "
113527|NCT02081443|"~     Cangrelor is a potent intravenous P2Y12 receptor inhibitor with rapid onset and offset of~     action associated with a greater reduction in ischemic events, including stent thrombosis, in~     patients undergoing stent procedures who have not been pretreated with clopidogrel. In vitro~     investigations have shown cangrelor to be associated with more rapid, potent, and consistent~     platelet inhibition in patients on maintenance prasugrel therapy exposed to a re-loading dose~     of prasugrel. However, if cangrelor exerts similar effects in ticagrelor treated patients~     remain unknown. The aim of the present study is to evaluate the effects on platelet function~     achieved after in vitro incubation with cangrelor in patients on ticagrelor maintenance dose~     who receive a loading dose of ticagrelor.~   "
113528|NCT02081430|"~     The purpose of this study is to determine the immediate effects of cervicothoracic~     manipulation and upper trapezius stretching on upper trapezius pressure pain threshold and~     cervical ROM.~   "
113529|NCT02081417|"~     Patient-Centered Trauma Treatment, i.e., treatment delivered by peers with lived-experience,~     has the potential to increase access to trauma treatment in underserved communities. This~     could positively impact the lives of millions of people as 70% of adults in the U.S have~     experienced a traumatic event and the consequences of trauma are devastating and far~     reaching, including chronic and comorbid physical and mental health problems. The most known~     consequences of trauma include post-traumatic stress disorder (PTSD) and substance use~     disorders (SUDs). Seeking Safety (SS) is the most effective evidenced-based treatment for~     co-occurring trauma, PTSD and SUDs. While no specific degree or experience level is required~     to conduct SS, all the evidence comes from studies using trained clinicians to implement the~     treatment, including social workers, psychologists, and psychiatrists. However, these~     research findings do not generalize to underserved communities that lack mental health~     professionals. Innovative approaches to treatment, such as peer-delivered services, are~     required to meet the demand for care in underserved areas. While the benefits of~     peer-delivered services have been well-documented in many areas, the value of peers in the~     provision of trauma-treatment is unknown. A theoretical basis supports the potential for~     peer-delivered trauma-treatment to be effective in addition to the strong therapist-patient~     bond, (i.e. therapeutic alliance (TA), which is an important predictor of treatment outcome~     and a typical result of peer-patient relationships.~      Our research question is whether there is a difference between peer-led SS (PL-SS) groups and~     clinician-led SS (CL-SS) groups in improving the lives of people with trauma, PTSD and SUDs?~      The investigators have three specific aims:~        1. Determine the effectiveness of PL-SS groups compared to CL-SS groups in decreasing~          substance use and PTSD symptoms and improving coping skills, overall mental health and~          physical health. Hypothesis: PL-SS compared to CL-SS groups will be as effective in~          improving outcomes.~        2. Compare levels of TA among PL-SS and CL-SS groups and examine the impact of TA on~          outcomes.Hypotheses: Levels of TA will be higher and will play more of a role in~          impacting outcomes in the PL-SS compared to CL-SS groups.~        3. Determine if the standard Seeking Safety Instructor Training (SS-IT) is adequate for~          peers. Hypothesis: Peers will identify topics that will enhance the SS-IT.~   "
113531|NCT02081391|"~     The purpose of the study is to evaluate the efficacy of tapentadol oral solution, based on~     the total amount of supplemental opioid analgesic used over 12 hours or 24 hours after~     initiation of investigational medicinal product in children and adolescents who have~     undergone surgery that would produce moderate to severe pain during opioid treatment.~   "
113532|NCT02081378|"~     The design of a phase I, open label, dose finding study was chosen in order to establish a~     safe and tolerated dose of single agent ABL001 in CML and Ph+ ALL patients who are relapsed~     or refractory to or are intolerant of TKIs, and of ABL001+Nilotinib, ABL001+Imatinib and~     ABL001+Dasatinib in Ph positive CML patients who are relapsed or refractory to TKIs.~   "
113533|NCT02081365|"~     Dental and health anxiety are common and potentially distressing problems, for both patients~     and health care providers. Anxiety has been identified as a barrier to regular dental visits~     and as an important target for enhancement of oral health-related quality of life. possible~     groups, (1) high dental anxiety and (2) low dental anxiety. The study aimed to develop and~     evaluate a computerized cognitive-behavioral therapy dental anxiety intervention (C-CBT) that~     could be easily implemented in dental healthcare settings.~      A cognitive-behavioral protocol based on psychoeducation, exposure to feared dental~     procedures, and cognitive restructuring was developed. A randomized controlled trial was~     conducted (N=151) to test its efficacy. Consenting adult dental patients who met inclusion~     (e.g., high dental anxiety) and exclusion criteria were randomized to one of two groups, (1)~     immediate treatment (IT) (n=74) or (2) a waitlist control (WL) (n=77).~   "
113534|NCT02081352|"~     This study has been designed to help determine how safe and effective DermaPure™ may be in~     treating hard-to-heal diabetic foot ulcers compared to the current standard of care.~   "
113535|NCT02081339|"~     Recent clinical introduction of anti-vascular endothelial growth factor agents may change the~     clinical course of macular diseases, including age-related macular degeneration (AMD),~     polypoidal choroidal vasculopathy (PCV), retinal angiomatous proliferation (RAP), central~     serous chorioretinopathy (CSC), myopic choroidal neovascularization (CNV), retinal vein~     occlusion (RVO), diabetic macular edema (DME), and so forth.~      Patients with such macular diseases are registered and and are followed up for 5 years with~     appropriate treatment for each patient. By the analysis of the correlation between initial~     examinations and final visual acuity, factors associated with good visual prognosis will be~     elucidated.~   "
113536|NCT02081326|"~     The purpose of this study is to see if repeat bacillus Calmette-Guérin (BCG) vaccinations can~     confer a beneficial immune and metabolic effect on Type 1 diabetes. Published Phase I data on~     repeat BCG vaccinations in long term diabetics showed specific death of some of the disease~     causing bad white blood cells and also showed a short and small pancreas effect of restored~     insulin secretion. In this Phase II study, the investigators will attempt to vaccinate more~     frequently to see if these desirable effects can be more sustained.~      Eligible volunteers will either be vaccinated with BCG in a repeat fashion over a period of~     four years or receive a placebo treatment. The investigators hypothesize that each BCG~     vaccination will eliminate more and more of the disease causing white blood cells that could~     offer relief to the pancreas for increased survival and restoration of insulin secretion from~     the pancreas.~   "
113537|NCT02081313|"~     This study aims at studying the natural history of Netherton syndrome (NS), to identify the~     consequences of LEKTI deficiency on the immune system and to characterize new molecular~     mechanisms involved in the disease.~   "
113538|NCT02081300|"~     The purpose of this study is to determine the safety and efficacy of an oral testosterone~     undecanoate formulation for use as testosterone-replacement therapy in men with low~     testosterone.~   "
113539|NCT02081287|"~     Inositol hexaphosphate (IP6, also called inositol hexakisphosphate, and phytic acid) is a~     naturally occurring phosphorylated derivative of myo-inositol. Myo-inositol has shown~     preliminary evidence of efficacy in controlling mood symptoms, and good tolerability in~     bipolar disorder in some studies, but failed to establish efficacy in subsequent~     meta-analyses. In the investigators proposed work, the investigators plan to orally~     administer the calcium/magnesium salt of IP6 (2,000-3,000 mg daily in two divided doses) to~     paid research subjects with a diagnosis of bipolar disorder who are in a depressed state, and~     who have failed an adequate course of treatment with lithium monotherapy. The investigators~     hypothesis is that IP6 may be similar to myo-inositol in terms of relieving depression, but~     more potent and effective. Our aim is conduct a preliminary pilot study in 30 subjects (15~     treated with IP6, 15 treated with lamotrigine, an active comparator) to assess the efficacy~     and tolerability of IP6 as an adjunctive treatment to lithium, the mood stabilizer most~     commonly used to treat bipolar disorder.~   "
113540|NCT02081274|"~     High tidal volume during mechanical ventilation has been reported to increase mortality in~     patients with acute lung injury or acute respiratory distress syndrome. High tidal volume was~     also reported to be associated with increased mortality in adult patients without acute lung~     injury or acute respiratory distress syndrome. However, the influence of high tidal volume on~     clinical outcome in pediatric patients who underwent surgery for congenital heart disease has~     not been evaluated yet. The investigators attempted to evaluate the effect of tidal volume on~     clinical outcome in both cyanotic and non-cyanotic congenital heart disease.~   "
113541|NCT02081261|"~     Acute kidney injury after cardiac surgery is a major complication after cardiac surgery and~     has been reported to be associated with adverse outcome. There have been many studies~     reporting risk factor of acute kidney injury after cardiac surgery, but the influence of~     perioperative variables related to anesthesia and perioperative medication has not been~     evaluated fully. The investigators attempt to evaluate the influence of perioperative~     clinical variables including preoperative medication, preoperative albumin level, uric acid~     concentration, anesthesia technique, use of hydroxyethyl starch, blood glucose level,~     intraoperative medication, perioperative cardiac function (systolic and diastolic function)~     and hemodynamic variables during surgery on the incidence of acute kidney injury after~     coronary artery bypass graft.~   "
113542|NCT02081248|"~     The study has two parts: (1) Randomized Study to evaluate the effectiveness of ETRIC, and (2)~     Evaluation Study to understand barriers to implementation of ETRIC.~   "
113543|NCT02081235|"~     Acute kidney injury (AKI) is a major complication after cardiac surgery and has been reported~     to be associated with adverse outcome. Previous studies have reported that the incidence of~     AKI in patients undergoing surgery for congenital heart disease is as high as 42% and AKI~     increase the patient mortality, intensive care unit stay and hospital stay. Previous studies~     have reported several risk factors for AKI after congenital heart surgery, however,~     perioperative variables including anesthesia-related factors have not been evaluated fully.~     Therefore, the investigators attempt to find out independent risk factors regarding~     perioperative variables.~   "
113558|NCT02081040|"~     To record diaphragm excursion in infratentorial brain lesions patients with dysphagia during~     coughing and compare them to those with supratentorial brain lesion patients with dysphasia~     and those with no dysphagia at a university affiliated rehabilitation department.~   "
113544|NCT02081222|"~     Viscoelastic hemostatic assay has been reported to be superior to predict perioperative~     bleeding in cardiac surgical patients compared with conventional blood coagulation test.~     However, the role of rotational thromboelastometry (ROTEM) in predicting perioperative~     bleeding and transfusion requirements in pediatric patients who undergoing surgery for~     congenital heart disease. Therefore, the investigators attempt to evaluate the predictability~     of intraoperative rotational thromboelastometry for perioperative bleeding and transfusion~     requirements in pediatric cardiac surgical patients by comparing with conventional~     coagulation test. The investigators also attempt to evaluate the correlation between ROTEM~     parameters, platelet count, and results of conventional coagulation test results.~   "
113545|NCT02081209|"~     The purpose of this study is to compare the performance of a cryolipolysis system using~     various treatment parameters for non-invasive reduction of subcutaneous fat in the lateral~     thighs.~   "
113546|NCT02081196|"~     The purpose of this study is to evaluate the safety and efficacy of non-invasive subcutaneous~     fat layer reduction with an alternative treatment parameter.~   "
113547|NCT02081183|"~     This study will compare the efficacy of CellCept [0.5-2 grams per day (g/day) orally (p.o.)]~     and cyclophosphamide [0.5-1 grams per square meter (g/m2) quarterly] as maintenance treatment~     for patients with lupus nephritis. All patients will receive induction treatment with~     cyclophosphamide (0.5-1g/m2 monthly) for 6 months, and will then be randomized to the~     maintenance phase of the study for a further 6 months, followed by 6 months of treatment-free~     follow-up. The anticipated time on study treatment is 12 months.~   "
113548|NCT02081170|"~     The purpose of this study is to determine the effectiveness of intravitreal autologous~     platelet concentrate (APC) injection during the surgery for refractory macular holes.~   "
113549|NCT02081157|"~     This study is to assess the physician preference in the clinical performance of the GalaFLEX~     mesh in soft tissue reinforcement during elective (cosmetic) plastic surgery to the breast,~     in particular the breast lift mastopexy and breast reduction procedures~   "
113550|NCT02081144|"~     This is a pilot study to test the feasibility of conducting a text based smoking cessation~     trial with Emergency Department patients who are smokers.~   "
113551|NCT02081131|"~     The aim of this study is to compare the two surgical approaches namely laparoscopic~     pancreatoduodenectomy and open pancreatoduodenectomy for management of periampullary and~     pancreatic head cancers in terms of parameters like hospital stay, pathological radicality,~     complication rate, peri-operative and post operative outcomes.~   "
113552|NCT02081118|"~     The purpose of this study is to determine the optimal dose or doses of HM11260C, when~     administered once a month under the skin, to improve the control of blood sugar levels in~     patients with early-stage type 2 diabetes mellitus (T2DM).~   "
113553|NCT02081105|"~     Lung recruitability is essential for optimal Positive end-expiratory pressure (PEEP)~     selection in ARDS patients. It is defined as the potential for the non aerated or poorly~     aerated lung mass to become aerated due to the increase in airway pressure. PEEP contributes~     to lung recruitment mostly by maintaining some amount of the end-inspiratory recruitment at~     the end of expiration. PEEP also stabilizes patency of the small airways and minimizes the~     repeated opening and closing of them during the breathing cycle, which is implicated in a~     further lung inflammation. The gold-standard method for assessing lung recruitability is lung~     CT scan. For economic and feasibility this technique cannot be used in routine. Therefore,~     techniques that can be used at the bedside to measure lung recruitability are very well~     known. The measurement of recruited lung volume (Vrec) by using pressure-volume curve~     generated by the ventilator is another reference method to approach lung recruitment. It can~     be done at the bedside. Chest-X-Ray (CXR) is an interesting option as done in routine in this~     setting. Furthermore, it allows quantifying aeration thanks numerical image processing and a~     regional approach. In a preliminary one-center study we found a significant negative~     correlation between the amount of Vrec and the reduction in lung density measured by digital~     CXR between 5 and 15 cm H2O PEEP. In present study we would like to extend this previous~     result on a larger number of patients in a multicenter investigation.~   "
113554|NCT02081092|"~     The purpose of this study is twofold: to assess routine cat scan (CT) imaging as a biomarker~     for removal of lipoprotein surfactant via lung lavage (where CT is the gold-standard imaging~     technique for density quantification), and to utilize a novel UTE MRI protocol to similarly~     quantify surfactant removal. This study will also serve to generate baseline scanning that~     may aid in developing analytical tools to evaluate and treat specific lung regions of~     patients with PAP.~   "
113555|NCT02081079|"~     This study is to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir~     (LDV/SOF) fixed-dose combination (FDC) in participants with chronic genotype 4 or 5 hepatitis~     C virus (HCV) infection as measured by the proportion of subjects with sustained virologic~     response (SVR12), defined as HCV RNA < lower limit of quantification (LLOQ) 12 weeks after~     discontinuation of therapy.~   "
113556|NCT02081066|"~     The reverse cholesterol transport (RCT) pathway, which involves the centripetal movement of~     free cholesterol from peripheral tissues, including the vessel wall, to the liver represent~     the primary mechanism by which HDL protects against atherosclerosis and by which it may~     induce plaque regression. Recent data reveal that the capacity of HDL to efflux cholesterol~     from macrophages, a metric of HDL function reflecting the initial step of the RCT, is~     clinically relevant, displaying a strong inverse association with both carotid intima-media~     thickness and the severity of angiographic CAD; such observations were independent of HDL-C~     levels.~      In human, the Cholesteryl Ester Transfer Protein (CETP), represents a key protein of the RCT~     pathway and mediates redistribution of neutral lipids between lipoproteins, has been~     identified as a potential therapeutic target against atherosclerosis. It is known that CETP~     activity correlates with HDL-C levels and represents a key modulator of the ability of whole~     plasma to mediate free cholesterol efflux from human macrophages.~      Recent studies showed that 23% of endogenous plasma CETP activity variability is explained by~     plasma LDL-C (12.0%), HDL-C (6.4%) and TG (4.4%) whereas sex and BMI accounted together for~     only 0.7% of its variability. Scoring patients for cardiovascular risk on the basis of their~     plasma lipid levels (TC, TG, LDL-C and HDL-C), revealed that patients with high~     cardiovascular risk (score ≥3) displayed a mean endogenous plasma CETP activity above 34%.~     Therefore plasma CETP activity represents a potent indicator of cardiovascular risk in~     patients with metabolic disorders since it integrates major independent risk factors.~      The objective of this study is to decipher the relationship between CETP, HDL efflux capacity~     and the development of atherosclerosis in humans in order to identify CETP as a potent~     biomarker of atherosclerosis distribution.~   "
113557|NCT02081053|"~     To evaluate the clinical outcomes of minimally invasive targeted radiofrequency tumor~     ablation (t-RFA) and kyphoplasty (also known as vertebral augmentation) in painful metastatic~     lesions in the spine.~   "
113563|NCT02080975|"~     Successful radio frequency (RF) cardiac catheter ablation requires the creation of lesions by~     delivering energy while maintaining adequate catheter contact with the endocardium.~     Unfortunately, it is difficult to identify contact intraoperatively as a typical RF ablation~     catheter lacks clear indications of contact. We propose to use the Boston Scientific~     IntellaTip MiFi catheter to explore whether characteristics of the electrograms produced by~     the mini-electrodes on the ablation tip could help confirm tissue contact. Using an~     ultrasound catheter to define instances of clear contact and non-contact, we will determine~     whether the micro-electrodes produce sufficient information to confirm catheter contact. We~     propose that the MiFi catheter produces sufficient signal characteristics that can be used as~     an effective surrogate for adequate tissue contact.~   "
113564|NCT02080962|"~     Radiotherapy is a treatment considered standard for non melanoma skin cancer. This~     institution uses schemes of 4 to 6 weeks of treatment. The objective of the study is to~     perform radiation therapy in 1 to 2 weeks, depending on the size of the lesion.~   "
113565|NCT02080949|"~     Brain metastases occur in 20-40% of patients with metastatic cancer. The standard treatment~     is based on whole brain radiation therapy and local treatment of metastases as neurosurgery~     or radiosurgery. However, many cases can not receive a standard local treatment, and local~     relapse occurs in almost 50% of cases treated with only whole brain irradiation. There are~     retrospective studies of increased radiation dose at the site of metastasis with~     hypofractionated stereotactic radiotherapy (HSRT) with favorable results, but there are no~     controlled studies regarding the safety of radiation dose in these situations. This study is~     a phase I study to evaluate the maximum tolerance dose (MTD) with HSRT as a way to increase~     the dose of radiation after the WBRT for patients with 1-3 brain metastases not eligible for~     surgery or RS.~   "
113566|NCT02080936|"~     Peripheral muscle mass and strength are relevant indicators of COPD survival. Current~     guidelines recommend to assess muscle strength only in muscle wasted patients. However, a~     recent study reported quadriceps weakness without muscle wasting (Menon, M et al. Resp.~     Res.2012, 13:119). Thus, these guidelines raise the risk to miss out some weak patients. In~     clinical settings, fat-free-mass index (FFMI) is indicated as a simple index to assess muscle~     wasting. We aimed at determining the prevalence of patients entering in pulmonary~     rehabilitation (PR) a priori not eligible for muscle strength evaluation given the lack of~     muscle wasting clinical signs.~   "
113567|NCT02080923|"~     The proposed study is a test of the feasibility and preliminary efficacy of a brief~     motivational interview style intervention. The intervention will take place in the pediatric~     emergency department of the Boston University Medical Center by a trained interventionist and~     will follow an intervention manual developed by a team of dating abuse and brief intervention~     experts. The study will involve two randomized groups of youth age 15-19: one group will~     receive the intervention and the other will not. The study will compare changes in data from~     baseline to 3- and 6-month follow-up for those in both groups. Outcomes including dating~     abused related knowledge, attitudes about the use of violence to resolve conflict, and dating~     abuse behavior (perpetration and/or victimization) will be assessed.~      The hypothesis of this study is that youth who receive the intervention will show~     improvements in dating abuse related knowledge, attitudes and behavior that are maintained~     for 6 months, while those in the control group will show no similar change.~   "
113568|NCT02080910|"~     This is a randomized controlled trial with a 3-month psychoeducational program as~     intervention, followed by a 3 month observational period. The purpose of this study was to~     examine whether a psychoeducational program focusing on equipping caregivers with~     problem-solving skills would improve caregiver's problem-solving abilities, their~     psychological responses and caregiving resources, and would minimize the use of health and~     social services among stroke survivors.~   "
113569|NCT02080897|"~     The purpose of this study is to evaluate the role of palliative surgery in improving Quality~     of Life (QoL) and symptom control for patients who present with a Soft Tissue Sarcoma (STS)~     and metastatic lung disease. Responses to clinical Edmonton Symptom Assessment System -~     Sarcoma Modified ( ESAS-SM) questionnaire for patients who have undergone surgery for~     resection of the primary tumour will be compared to those that are unable to have surgery.~     Data collected from this questionnaire can highlight the benefits in patients' QoL who~     receive palliative surgical resection, and whether these benefits surmount those who are not~     treated with palliative surgery.~   "
113570|NCT02080884|"~     This study will examine the effectiveness of MabThera therapy added to a standard~     chemotherapy regimen for the treatment of previously untreated chronic lymphocytic leukemia~     (CLL). Patients who have received a single prior MabThera plus chemotherapy treatment are~     eligible. The overall response rate of patients treated for approximately 5 months (as per~     current label guidelines) will be analysed according to various factors (i.e., age,~     concurrent treatment, and chromosomal abnormalities).~   "
113571|NCT02080871|"~     Evaluation of the Gore(R) VIABAHN BX for the treatment of arterial occlusive disease in the~     common and/or external iliac arteries.~   "
113572|NCT02080858|"~     Background:~      The acute coronary syndrome (ACS) is a complication of coronary artery disease (CAD) and~     associated with increased mortality. Dual antiplatelet therapy of acetylsalicylic acid (ASA)~     with P2Y12 receptor antagonists such as clopidogrel is a cornerstone in the treatment of~     patients with advanced CAD. Due to delayed onset of action, intersubject variability or~     resistance to clopidogrel, different platelet aggregation inhibitors have been developed.~     Ticagrelor is a reversible P2Y12 receptor antagonist with superior efficacy compared to~     clopidogrel in the prevention of cardiovascular death in these patients.~      Atrial fibrillation (AF) is also associated with thromboembolic events and substantial~     mortality. Beside vitamin K antagonists (VKA, phenprocoumon) for stroke prevention in~     patients with AF, the direct factor Xa inhibitor apixaban has recently received approval for~     prophylactic treatment of patients with non-valvular AF.~      However, there is a lack of efficacy or safety data for the combined impact of antithrombotic~     drugs in patients requiring arterial and venous thromboembolic prophylaxis due to their~     underlying co-morbidities. One trial suggests treatment with VKA + clopidogrel without ASA as~     equal effective as antithrombotic triple therapy (with ASA) in this population. However, the~     effect in combination with novel oral anticoagulants has not been investigated so far.~      Study objectives:~      To evaluate the effect of ticagrelor + apixaban in combination with or without ASA at steady~     state on markers of coagulation activation and on thrombus size in an ex vivo perfusion~     chamber experiment. Additionally, plasma samples will be analysed for PK-data (ticagrelor &~     apixaban concentrations)~      Study design:~      A single-centre, prospective, sequential, controlled, analyst-blinded study in two groups.~     Subjects will receive ticagrelor + apixaban in combination with (study A) or without (study~     B) ASA. All IMPs will be administered at doses indicated for stroke prevention in AF (lower~     dose: 2.5mg due to ethical concerns) or ACS. Markers on thrombin generation and platelet~     activation will be studied in venous blood where coagulation is in resting state and in shed~     blood where the clotting system is activated in the microvasculature in vivo: prothrombin~     fragment 1+2 (F1+2), thrombin-anti-thrombin (TAT), β-thromboglobulin (β-TG). Additionally,~     inhibition of factor Xa activity and concentrations of ticagrelor and apixaban will be~     assessed in venous blood. Further, thrombus size of clots formed in an ex vivo perfusion~     chamber will be determined by measurement of D-Dimer and p-Selectin levels.~      Study population A total of 40 healthy, non-smoking and drug-free male volunteers will be~     enrolled (study A and B; n = 20 per group).~      Main outcome variables:~        -  β-TG in shed blood~      Additional outcome variables:~        -  F1+2 and TAT in shed blood~        -  fibrin formation (D-Dimer) and platelet deposition (p-Selectin) in an ex vivo perfusion~          chamber model of thrombosis~        -  β-TG, F1+2, TAT & inhibition of factor Xa in venous blood~        -  PT, aPTT and ACT in venous blood~        -  ticagrelor & apixaban plasma concentrations~        -  shed blood volume~   "
113573|NCT02080845|"~     The Hershey Company is interested in investigating the effects of various chocolate beverages~     on brain physiology and cognitive function. The main substances in the drinks that are known~     to influence the brain are caffeine and related chemicals such as theobromine. Caffeine and~     chemicals related to caffeine are all naturally occurring and all potentially alter brain~     physiology. This study will evaluate changes in brain blood flow and cognition following the~     consumption of drinks with various combinations of the Primary Ingredients. The study~     proposed here will evaluate ingredients in a 4-arm cross-over double-blind design in an~     attempt to understand the differential effects of these compounds in chocolate drinks.~   "
113574|NCT02080832|"~     The purpose of this study is to examine the role of brain MRI findings in predicting~     treatment outcomes among individuals with cocaine dependence.~   "
113575|NCT02080819|"~     This project proposes to investigate the role of brain connectivity in the mechanism of~     treatment response to dopaminergic medications in cocaine dependence.~   "
113576|NCT02080806|"~     Stroke patients with dysphagia have restrictive lung dysfunction and impaired cough response.~     This pilot study was performed to determine if Mechanical Insufflation Exsufflation (MIE)~     therapy can help recover impaired cough function.~   "
113577|NCT02080793|"~     This study will be based on two questionnaires~        1. One specific questionnaire that has already been developed from social sciences~          interviews conducted in men who have been treated for localized prostrate cancer, with a~          good or intermediate prognosis. This questionnaire comprises 11 pairs of scenarios. Each~          scenario gathers in a random manner, the modalities of 7 possible characteristics of the~          management strategy for localized prostrate cancer, with a good or intermediate~          prognosis:~             -  the risk of death at 5 years (modalities: 5%, 15%),~             -  the risk of impotence (modalities: 0%, 25%, 50%, 75%),~             -  the presence of urinary leaks (modalities: no protection during the day, one~               protection pad per day, several protection pads per day),~             -  the duration and frequency of care provided (modalities: 2 days of care in your~               whole life, 7 days of care in your whole life, 5 half-days of care per week for 8~               weeks, every 3 months for 2 years then every 6 months for life),~             -  ablation of the prostate (modalities: Yes, No),~             -  the existence of possible treatments in case of aggravation or recurrence~               (modalities: Yes, No),~             -  the nature of the technology used (modalities: innovative technology, standard~               technology).~           The objective is to ask each participant of the study for each pair of scenarios, to~          choose from the two scenarios (binary-choice survey), the scenario he prefers.~        2. The Spielberger Inventory Trait scale to evaluate stable characteristics in the~          propensity to anxiety in study participants.~   "
113578|NCT02080780|"~     The purpose of this study is to evaluate the drug-drug interaction potential of~     clarithromycin XL on Diltiazem hydrochloride (DTZ) 2% cream.~   "
113579|NCT02080767|"~     The purpose of this clinical protocol is to treat individuals with Tecovirimat after exposure~     to orthopox viruses.~   "
113580|NCT02080754|"~     Lung aspiration can occur when a rapid sequence induction of anesthesia is performed~     (emergency and/or presence of at least one risk factor for regurgitation of stomach~     contents).~      The aim of this study is to assess the Sellick maneuver, which is recommended for patient at~     high risk of aspiration of gastric content during induction of general anesthesia, despite~     the lack of solid evidence of its efficacy and possible adverse effects The primary outcome~     of this non inferiority study is the incidence of lung aspiration whether this maneuver is~     effectively applied or sham.~   "
113581|NCT02080741|"~     This study will include 100 patients with Type 1 and Type 2 diabetes, split into 2 groups of~     50 patients according to their behaviour type, and their adaptation to different factors of~     stress encountered in their lives:~        -  the first group will consist of patients with a characteristic Type A behaviour profile,~          that is to say patients with a proactive, impatient behaviour pattern~        -  the second group will consist of patients with a characteristic Type B behaviour profile~          that is to say patients with a calm, slow behaviour pattern The objective is to know~          if the different behaviour patterns are associated with distinct biological markers~          likely to influence the evolution of the diabetes.~      Participation in this study will be approximately 1h30, patients will participate ONCE ONLY:~        1. they will answer simple questions about their disease and then complete 3 questionnaires~          each with 14 items.~        2. they will meet a clinical psychologist for an interview lasting approximately 45 minutes~          recorded on an audio recorder. The consultation will be used to seek links between the~          psyche and the disease.~        3. they will provide one blood sample of 12 ml (equivalent to a soup spoon) drawn in the~          morning.~   "
113582|NCT02080728|"~     The surgeon places the catheter in the thickness of the oblique internal and transverse~     muscles at the moment the wall is closed, under visual control. A multiperforated catheter~     whose length corresponds to that of the incision is chosed. The catheter will deliver one of~     two products chosen at random: either ropivacaine or placebo.~      This study will evaluate postoperative pain during the first 24 hours thanks to a recognized~     indicator the VAS (Visual Analogue pain Scale). The total consumption of analgesics will also~     be recorded, starting with the titration of morphine in the post-op room, and then the~     consumption of classical analgesics in the nephrology department. These will only be given if~     the VAS score is equal to 4 or above.~      This is a prospective, single-centre, controlled, double blind study of ropivacaïne 0.2%~     versus placebo in continuous TAP block during the first 24 hours after the operation in~     patients undergoing kidney transplant surgery.~   "
113583|NCT02080715|"~     In this study, pharmacologic effects of COMT inhibition during sleep deprivation in healthy~     subjects in dependence of their Val158Met genotype of COMT are studied. Potential effects are~     identified by measurement of vigilance and cognitive performance as well as EEG measurements~     during wake and sleep.~        -  Trial with medicinal product~   "
113584|NCT02080702|"~     The aim of this non-interventional study is to evaluate the efficacy of a monofilament,~     mid-term absorbable suture material (Monosyn®) for anastomosis performed in the~     gastrointestinal tract using the frequency of anastomosis leakage as a primary parameter.~      Postoperative complication rate, length of hospital stay, costs, time to perform the~     anastomosis and handling will serve as secondary endpoints.~      The question is addressed, whether a monofilament suture material is as effective as a~     braided suture material for anastomosis construction within the gastrointestinal tract.~   "
113585|NCT02080689|"~     The influence of Decipher test on urologist and patient treatment plan choices immediately~     post RP and at the time of PSA rise or BCR~   "
113586|NCT02080676|"~     Purpose of study: to check the effect of medical cannabis given for approved medical~     indications on ocular parameters including intra ocular pressure, optic nerve fibers~     thickness and choroidal thickness.~   "
113611|NCT02080351|"~     This research study is designed to investigate the effects of a simple cognitive task (a~     memory reactivation cue following by playing the computer game Tetris) on flashbacks and~     other post-traumatic stress symptoms after a road traffic accident. Patients presenting to a~     hospital emergency department soon after a road traffic accident will be randomly allocated~     to either the simple cognitive task intervention or usual care. Participants will be followed~     up at one week and one month. It is predicted that participants given the simple cognitive~     task intervention will develop fewer flashbacks and less severe clinical symptoms than those~     who are not. This will inform the potential future development of a simple technique to~     prevent distressing psychological symptoms after a traumatic event.~   "
113612|NCT02080338|"~     The purpose of this study is to compare the 0.018-inch and 0.022-inch bracket slot systems to~     determine which is more effective for orthodontic treatment .~   "
113587|NCT02080663|"~     In cases of severe arthritis of the wrist, surgical removal of the scaphoid, lunate and~     triquetrum bones or proximal row carpectomy (PRC) is a well-known procedure. This procedure~     converts the wrist in a simple hinged joint but allows us to preserve a certain range of~     motion in the wrist. One of the main disadvantages of PRC is the risk of developing arthritis~     between the head of the capitate and the lunate fossa. The long-term follow-up of this~     procedure has always been a reason for concern. The investigators set up this retrospective~     study to evaluate the long-term results of the procedure in the investigators institution.~      Also, the shape of the head of the capitate may play a role in the development of arthritis.~     A more round shape could distribute the forces more equally and thus prevent the progression~     of cartilage damage~      The study hypothesis is:~        -  PRC preserves range of motion and force in the long term (more than 10 years~          postoperatively).~        -  A more round head of the capitate is associated with an increased risk of developing~          arthritis in the new joint.~   "
113588|NCT02080650|"~     This pilot study will aim to determine whether circulating tumor cells (CTCs) can be captured~     using the novel cMET based ferrofluid. The primary objective of this pilot study will be to~     describe the numbers of c-MET expressing cells that can be detected by the c-MET CTC capture~     technique. These data will be separated by disease site. The investigator will also describe~     the detection rates of both the c-MET CTC capture and the EpCAM CTC capture techniques in~     each patient, also separated by disease site.~   "
113589|NCT02080637|"~     Purpose: To evaluate the pharmacokinetics, bioavailability and hemodynamic efficacy of~     ambrisentan after Fontan surgical palliation of single ventricle heart defects.~      Study activities and population group: Children undergoing Fontan surgical palliation for~     single ventricle defects will be eligible for the study. Up to 20 subjects will be enrolled~     (16 ambrisentan, 4 placebo) and will receive 3 days (3 doses) of ambrisentan starting on~     post-operative day #1 upon returning from the operating room. Ambrisentan plasma levels will~     be obtained at specified time points during treatment. Post-operative monitoring lines will~     be used to measure effects of ambrisentan on hemodynamics and pulmonary / systemic~     endothelial function.~   "
113590|NCT02080624|"~     Sturge-Weber syndrome (SWS) is a rare congenital neuro-cutaneous disorder considered as a~     rare or orphan disease. SWS is characterized by a capillary vascular malformation (CM)~     localized on the skin of the face, eyes and central nervous system. Given the localization~     and the extent of the CM, children with SWS are particularly prone to developing severe~     psychological problems. The standard treatment for CM is pulsed dye laser (PDL) although in~     these cases whitening of the lesion is rarely achieved. Combining topical rapamycin, a~     specific inhibitor of the mammalian target of rapamycin, with PDL is hypothesised to be a~     good therapeutic option in these patients.~   "
113591|NCT02080611|"~     The investigators hypothesize that a garment-integrated sensing system will be able to detect~     with clinical accuracy the position of the spine. The investigator will evaluate this using~     healthy adult volunteers, who will don sensing garments and assume a series of spinal~     postures. Concurrent with garment sensing, the participant's spine position will be measured~     using a motion-capture system that uses reflective markers to detect positions of markers in~     3D space.~      The motion-capture system provides a gold-standard reference measure to which the sensing~     garments will be compared. Because the investigators are evaluating the accuracy of the~     sensing garment, it is only necessary that the investigator test the garments on participants~     with subtly different body shapes. Healthy adult volunteers provide an adequate input to the~     sensing signal.~   "
113592|NCT02080598|"~     The aims of this cross over prospective study are to demonstrate that smoking two cigarettes~     do not change the gastric contents and volume in fasting volunteers.~   "
113593|NCT02080585|"~     The present study used a cluster-randomized controlled trial to evaluate the effects of a~     computer-tailored, pedometer-based Physical Activity (PA) intervention delivered through the~     Internet. An invitation e-mail with study information was sent to managers of 18 white-collar~     workplaces. Eight workplaces consented to participate. All employees of a single workplace~     were allocated at random to either the intervention or a waiting list control group, in order~     to avoid contamination between employees receiving the intervention and those who were not~     receiving the intervention. Subsequently, employees of the participating workplaces were~     recruited by e-mail. Only Dutch speaking employees between 18 and 65 years old, who had~     access to the Internet at work or at home, were eligible. Interested employees could sign up~     by returning a confirmation e-mail to the researchers. On receiving this information, a~     meeting was organized in each of the eight worksites to deliver all documents for baseline~     measurement (T0) to the participants, including an informed consent form, a blinded~     pedometer, an activity log and a self-administered questionnaire. During this meeting,~     information was provided on how to use the pedometer, how to log PA activities and how to~     answer the questionnaire. Moreover, the participants were asked to adhere to their usual PA~     pattern throughout the baseline measurement. After one week, all measurement tools were~     collected, and average daily step counts were calculated. At this point, participants in the~     intervention condition received (1) a booklet with information on how to increase steps, (2)~     a non-blinded pedometer, which they could use for three months, and (3) a username, a~     password and the amount of average daily steps, calculated by the researchers, so that~     participants could use this number when requesting the online computer-tailored step advice.~     Participants in the control condition did not receive any of the above mentioned intervention~     components. One and three months later, all participants again received a blinded pedometer,~     which was worn for one week. When wearing the blinded-pedometer one month (T1) and three~     months (T2) post baseline, intervention participants were allowed to also were the~     non-blinded pedometer. Furthermore, the same self-reported questionnaire was used to measure~     PA level at T1 and T2 in order to test the effectiveness of the intervention.~   "
113594|NCT02080572|"~     Changes in deep brain stimulation (DBS) settings can have a delayed effect on gait function,~     which makes it impractical to optimize DBS for gait parameters in the clinic. Wearable~     movement sensors could be used to assess gait impairment in the patient's home hours after~     treatment adjustments are made in the clinic. This study aims to quantitatively evaluate the~     effects of turning off deep brain stimulation on lower extremity and gait function over three~     hours. This study will provide vital information about our patient worn system's ability to~     detect changes in lower impairment over time, which could be used to assist with DBS tuning~     for the lower extremities and gait in the future.~   "
113638|NCT02080000|"~     The aim of this study is to investigate whether the use of a simple feature on the 12 lead~     electrocardiogram (ECG) to optimise pacemaker device programming can have clinically relevant~     benefit to patient management. More specifically it is to investigate whether using the~     R-wave in V1 of the surface ECG to guide the timings between left (LV) and right ventricular~     (RV) pacing improves response to Cardiac Resynchronisation Therapy.~   "
113639|NCT02079987|"~     The purpose of this study is to find out if a new way of helping patients after they leave~     the Emergency Room (ER) improves their quality of life. The purpose is also to find out if~     the new way of helping decreases ER use.~   "
117410|NCT02030704|"~     To determine the ability of semi‐automated plaque assessment in cardiac computed tomography~     angiography (CCTA) and high sensitive troponin T (hsTnT) for the risk stratification of~     patients at intermediate risk for coronary artery disease (CAD).~   "
113595|NCT02080559|"~     This randomised, open-label, single-centre, descriptive study aims to investigate gene~     expression (i.e what genes are 'switched on' and 'off') following vaccination with 4CMenB and~     to relate this to vaccine reactions and to immune response.~      160 healthy Caucasian infants aged 8-12 weeks (at time of first visit) who have not yet~     received their routine infant immunisations will be recruited. Participation in the study~     will be limited to to Caucasian infants (defined as having two Caucasian parents). This is so~     that baseline variability in gene expression data which is to some degree affected by~     ethnicity is reduced.~      Participants will be randomised to either a 'test' group or 'control' group depending on what~     4CMenB schedule they receive, with 80 infants in each.~      All participants will receive the usual paediatric immunisations according to the UK national~     immunisation schedule. In addition, participants in the test groups will receive 4CMenB at 2,~     4 and at 12 months while those in the control groups will receive the same vaccine at 5, 7~     and 13 months. Blood samples will be taken from each infant at specified time points before~     and after vaccination to address the objectives of the study.~      In addition, oro-pharyneal swabs will be obtained around different vaccination timepoints to~     investigate the effect of 4CMenB vaccination on the oro-pharyngeal Neisseria microbiome.~   "
113596|NCT02080546|"~     Purpose of this randomized control study is to determine if the mode of electrothermal~     colpotomy incision affects (1) the degree of thermal injury at the time of laparoscopic~     hysterectomy or (2) the incidence of clinical surrogates of compromised vaginal cuff healing.~     Women already scheduled for TLH will be randomized to colpotomy incision with the V mode or~     standard cut/coag form of electrothermal energy.~      Prevalence of vaginal cuff injury will be calculated, and cross tabulation tables will be~     used to examine the association fo dehiscence with proposed risk factors in the retrospective~     part of the study. In the randomized controlled trial, depth of thermal injury will be~     compared between the two groups, and a chi-square test will be used to test for a difference~     in clinical outcomes between the two groups. There is little risk associated with this study~     above the normal surgical risks; however, the V mode has not been previously been studied for~     its use in making a colpotomy incision. Loss of confidentiality is a risk of the study, but~     all samples will be de-identified and given a unique study number, and only individuals~     directly involved in the study will be given access to the study information.~   "
113597|NCT02080533|"~     Pulmonary arterial hypertension (PAH) is a chronic illness characterized by increased~     pulmonary pressures resulting in right heart failure and premature death. Common symptoms~     that impair quality of life and functioning are dyspnea, fatigue and sleep disturbance. This~     trio of symptoms is highly prevalent and forms a symptom cluster (2 or more symptoms that~     co-occur) in PAH. From a biological, proinflammatory cytokines are implicated in dyspnea,~     fatigue and sleep disturbance; there is activation of the sympathetic nervous system (SNS)~     and an inherent inflammatory process in PAH that contributes to the pathophysiology, but the~     link to this symptom cluster has not been investigated. One novel, treatment for symptom~     clusters is slow-paced respiration therapy using the FDA-approved device, RESPeRATE. The~     device contains headphones and a sensor that attaches to the chest to detect inhalation and~     exhalation. Musical tones synchronize with the respiratory cycle to slowly guide the user to~     decrease respirations. RESPeRATE moderates effects of the SNS; lowers blood pressure;~     improves functional capacity and ejection fraction; and significantly decreases pulmonary~     pressures in left heart failure. The investigators will enroll 10 women with PAH to use the~     RESPeRATE device to perform slow-paced respiration for 15 minutes per day for 8 weeks to~     determine the feasibility and effects on the SNS and inflammatory activity and the symptom~     cluster. The investigator's overall hypothesis is that, as compared to baseline, after eight~     weeks of therapy women with PAH who receive slow-based respiration therapy will have lower~     SNS activity and inflammatory levels, and improved dyspnea, fatigue and sleep disturbance.~   "
113598|NCT02080520|"~     The potential for nattokinase to thin blood and to reduce blood clotting by positive~     antithrombotic and fibrinolytic effects presents a unique opportunity to safely study such~     effects on cardiovascular disease and cognition. Unfortunately, such studies of~     antithrombotic and fibrinolytic pathways of prevention have been limited due to lack of safe~     compounds and the adverse reactions associated with current agents such as Coumadin.~     Nattokinase, an over-the-counter supplement used for cardiovascular health, is the most~     active functional constituent of natto, a fermented soy product. Natto has been consumed~     primarily by the Japanese for over 1000 years, a population with one of the lowest risks for~     cardiovascular disease and dementia. Cardiovascular disease and dementia remain the most~     challenging age-related health risks of the 21st century for Americans necessitating~     development of further effective preemptive strategies. Whether reducing the propensity for~     thrombus formation and/or increasing fibrinolytic activity can prevent the progression of~     atherosclerosis and cognitive decline has not yet been determined.~      Using nattokinase under primary prevention conditions, the investigators propose to conduct a~     randomized, double-blinded, placebo-controlled trial to determine whether decreasing~     atherothrombotic risk can reduce the progression of atherosclerosis and cognitive decline.~     The investigators propose to randomize 240 healthy non-demented women and men to nattokinase~     supplementation or to placebo for three years. The primary trial end points will be~     measurement of carotid arterial wall thickness and arterial stiffness, early changes of~     atherosclerosis that can be measured safely by non-invasive imaging techniques. The secondary~     trial end point will be ascertained through change in cognition measured by a~     neuropsychological battery. In addition, biochemical blood measurements and in vitro studies~     will be conducted to compare the effects of nattokinase relative to placebo on blood~     coagulation and thrombus break-down capabilities, blood flow properties, inflammation and~     inflammatory activation of endothelial cells that line blood vessels.~      At the conclusion of this trial, the investigators expect to have sufficient evidence as to~     whether reducing the propensity for thrombus formation and/or increasing fibrinolytic~     activity can prevent the progression of atherosclerosis and cognitive decline. These results~     will provide novel and important data that will be informative concerning primary prevention~     through the atherothrombotic pathway. Providing evidence for a reduction in atherosclerosis~     progression and cognitive decline with nattokinase is likely to shift the current clinical~     paradigm for the prevention of these chronic age-related processes. In addition, such~     evidence will serve to create a new field of discovery and opportunity for prevention of~     cardiovascular disease and dementia.~   "
113599|NCT02080507|"~     The purpose of this study is to determine the safety and efficacy of rTMS as an alternative~     treatment to ECT. The study will also provide data for a power analysis to support a larger~     clinical trial if there is evidence of a clinically relevant treatment effect.~   "
113600|NCT02080494|"~     Tranexamic acid is an antifibrinolytic drug that has been used to decrease post-operative~     blood loss. This study is a prospective, randomized controlled trial investigating the use of~     tranexamic acid in fracture surgery around the hip and knee, in which significant blood loss~     (>300mL) is expected.~      The hypothesis of this study is that tranexamic acid will be associated with a decrease in~     post-operative blood loss, as well as a decreased need for allogenic blood transfusion, in~     patients who have fracture surgery around the hip and knee.~   "
113651|NCT02079831|"~     The aim of the proposed study is to provide important data on weight loss efficacy in~     overweight and obese adolescents on an isocaloric higher protein diet vs a lower protein diet~     utilizing the U.S. Department of Agriculture (USDA) MyPlate nutrition guide. The~     investigators hypothesize that the higher protein diet will result in greater weight loss due~     to increased satiety and better dietary adherence.~   "
113601|NCT02080481|"~     An FDA-approved product, InfinitiPlus (TM), is a needle guidance system that has been~     recently developed to guide clinicians in performing ultrasound guided nerve blocks. This~     system helps the clinician to align the needle with ultrasound beam while performing an~     ultrasound guided nerve block. InfinitiPlus (TM) has a unique open channel design allowing~     efficient needle movement while having improved needle shaft and tip visualization. This is a~     disposable system specifically designed for improving success rate of ultrasound guided block~     and patient safety.~      This study will be done with patients having elective knee surgery and a femoral nerve block~     with a catheter. The nerve block procedure will be performed under ultrasound guidance to~     help improve safety and efficacy of the injection. InfinitiPlus (TM) has been recently~     developed to try to improve needle guidance in the ultrasound guided nerve block procedure.~     This study will determine whether femoral nerve block procedures performed under ultrasound~     guidance with InfinitiPlus (TM) take less time than procedures performed with ultrasound~     guidance and a conventional block needle. The study will also determine whether the~     InfinitiPlus (TM) needle reduces the number of times the clinician attempts the procedure,~     reduces the cost of the procedure, increases the procedure success rate, and improves~     ultrasound visibility of the needle.~      Participants will be randomly assigned to either ultrasound guidance with the InfinitiPlus~     (TM) needle guidance system or ultrasound guidance with a conventional block needle. After~     surgery, pain will be rated every 30 minutes for the first 2 hours, then every 4 hours while~     awake for 24 hours. 24 hours after surgery, participants will be given a survey about pain~     treatment satisfaction and a questionnaire about recovery.~   "
113602|NCT02080468|"~     The primary objective of this study is to assess the effect of ethinyl estradiol~     (EE)/norgestimate, a weak cytochrome P450 (CYP) 3A4 inhibitor, on the pharmacokinetics (PK)~     of lomitapide and 2 primary metabolites, M1 and M3.~   "
113603|NCT02080455|"~     The primary objective of this study is to assess the effect of atorvastatin, a weak~     cytochrome P450 (CYP) 3A4 inhibitor, on the pharmacokinetics (PK) of lomitapide and its 2~     primary metabolites, M1 and M3.~   "
113604|NCT02080442|"~     The study will involve direct knowledge translation of a laboratory-based study of balance~     training for patients with COPD, first to the investigators PR program and then, after~     disseminating the results, this approach could be used to impact on clinical practice in any~     PR program.~   "
113605|NCT02080429|"~     Obesity rates in reproductive aged women in the United States are rising. It is now~     universally accepted that obesity is associated with many adverse pregnancy outcomes and~     post-operative complications following cesarean section. Recent studies have also shown an~     increased rate of cesarean section in obese women, adding to the already elevated rate of~     complications and adverse outcomes. Given the increased a priori risk for obese patients, it~     is vital that the investigators reexamine management practices routinely used for normal~     weight women in this specific high-risk population. Passive descent has been shown to~     increase the spontaneous vaginal delivery rate in non-obese women; however, high quality~     studies have never been performed in obese women. the investigators hypothesize that passive~     descent could improve the spontaneous vaginal delivery rate in nulliparous, obese women with~     regional anesthesia. This study will randomize women to passive descent for ninety minutes or~     active pushing upon entry into the second stage. Further, given that passive descent is~     widely accepted in the midwifery literature and clinical practice, the investigators~     anticipate that a high-quality study in the physician literature could increase the dialogue~     between practitioners and lead to development of best practices in this high-risk population.~   "
113606|NCT02080416|"~     The goals of this study is to determine if nelfinavir can target Epstein-Barr virus (EBV) and~     Kaposi sarcoma-associated herpesvirus (KSHV) in patients with certain cancers.~   "
113607|NCT02080403|"~     The objective of the study is to assess the efficacy and safety of PerioChip® (Chlorhexidine~     gluconate chip) in the treatment of patients with Peri-implantitis.~      The hypothesis of the study is that PerioChip® in adjunct to mechanical subgingival~     debridement is more effective in the treatment of peri-implantitis when compared to the~     common method of mechanical subgingival debridement alone. The primary efficacy measure will~     be the reduction in probing pocket depth at 6 months as measured at sites of qualifying~     target implant.~   "
113608|NCT02080390|"~     The purpose of this research study is to evaluate the effects of the chemotherapeutic drug,~     Trastuzumab (Herceptin) on the heart. Trastuzumab (Herceptin) is used to treat specific types~     of breast cancer and is known to cause weakening of the heart. Unfortunately, little is know~     as to why this this happens. The investigators want to identify any factors that may lead to~     the early detection, treatment and prevention of the cardiotoxicity (heart problem)~     associated with this drug.~   "
113609|NCT02080377|"~     The aim of this open label feasibility study is to determine recruitment rates to a~     randomised trial of glibenclamide compared with insulin (both in addition to maximum~     tolerated metformin) for the treatment of Gestational Diabetes Mellitus (GDM). This~     feasibility trial will inform the design of a future substantive multicentre trial to test~     the hypothesis that combination therapy with glibenclamide and metformin could reduce the~     number of pregnant women with GDM who require insulin and would be superior to metformin and~     insulin in terms of acceptability and cost effectiveness.~      Women with GDM who have failed monotherapy with metformin will be recruited and randomised~     to either receive glibenclamide (test arm) or standard care with insulin, both in addition to~     their maximum tolerated dose of metformin. Patients will be recruited from three of the~     antenatal clinics.~      This is a feasibility study in preparation for a large multicentre randomised trial to test~     the hypothesis that the addition of glibenclamide to metformin (combination therapy) could~     reduce the number of pregnant women with gestational diabetes mellitus requiring insulin,~     without compromising glycaemic control or other clinical outcomes. The investigators~     hypothesise that combination therapy with metformin and glibenclamide is likely to be~     preferable to metformin and insulin in terms of acceptability and cost.~   "
113610|NCT02080364|"~     This is a study to evaluate the efficacy and safety of azeliragon in patients with mild~     Alzheimer's disease. Patients will receive either azeliragon or placebo with a patient's~     participation lasting approximately 18 months.~   "
114875|NCT02063815|"~     The purpose of this randomized clinical trial was to compare caries prevention of a~     conventional resin-based sealant and a glass-ionomer sealant placed on occlusal pits and~     fissures over a one year period in a high caries children group. Additionally the~     concentration of Fluoride in saliva was evaluated.~   "
113613|NCT02080325|"~     This study aims to investigate the mechanistic processes involved in protein-induced~     satiety/satiation during weight loss in humans.~      Thsi study will investigate:~        -  How do high-protein weight loss (HPWL) diets rich in meat or soya based protein sources~          impact on profile of 'motivation to eat' both within a day and between days ?~        -  Do biomarkers of satiety alter differentially on meat or soya HPWL diet, as measured by~          monitoring alteration in plasma amino acids and gut-related hormones ?~        -  How does a vegetarian and meat-based weight loss diet impact on nitrosamine excretion in~          faecal samples, as an indicator of faecal toxicity?~      Previous work has indicated that high-protein (30% protein) weight loss diets are more~     satiating (produce less hunger) than normal protein WL diet (15% protein) or a diet~     supplemented with few amino acids. In previous work, a mixed source of protein has been used,~     mainly from meat (beef, chicken, fish). These types of diets have been criticised because of~     the potential negative side effects, including our own work on gut health. It might be that~     alternative vegetable sources of protein could fulfil the diet remit, to be satiating and yet~     still allow weight loss, and maintain a healthy gut.~      Design -within subject, randomised cross-over design after day 3. Each subject acts as their~     own control and will receive each treatment. 18-20 subjects to participate.~      Length of time - Conduct the two nutritional interventions over a period of 14 days, in order~     to reduce effects due to an acute change in nutritional intake.~      PROTOCOL Days 1- 3 - Normal Protein Maintenance diet (NP- MTD, 3 days)~        1. st ARM Days 4-17 - randomised to High Protein-Weight loss-Meat (HP-Soya,14 days),~        2. nd ARM Days 18-31 - randomised to High Protein-Weight loss-Soya (HP-meat,14 days),~   "
113614|NCT02080312|"~     This is a pilot study of patients with clinical symptoms of Ménière's disease using injection~     of diluted magnetic resonance imaging (MRI) contrast agent into the ear to evaluate inner ear~     structures.~      The goal is to reproduce imaging findings described by non-United States (US) institutions,~     improve on image quality with decreased scan time and evaluate the dynamics of the contrast~     movement into the inner ear structures.~   "
113615|NCT02080299|"~     Transcatheter aortic valve implantation (TAVI) has rapidly been adopted into clinical~     practice, but concerns have been raised regarding periprocedural complications like e.g.~     myocardial injury, stroke or acute kidney injury. Remote ischemic preconditioning (RIPC) with~     upper limb ischemia/reperfusion provides perioperative myocardial protection in patients~     undergoing elective coronary artery bypass surgery. The present study assesses protection of~     heart, brain and kidney by RIPC in patients undergoing TAVI. The study also addresses safety~     and clinical outcome.~   "
113616|NCT02080286|"~     The present study aims to compare the relative therapeutic efficacy of prism adaptation~     therapy combined with real versus sham tDCS. The investigators will test the hypothesis that~     the magnitude and duration of neglect improvement will be increased when prism therapy is~     combined with real tDCS compared to sham tDCS.~      A second objective is to test whether individual differences in baseline clinical or brain~     imaging measures can predict: 1) neglect severity or 2) inter-individual differences in~     patients' therapeutic response.~      A third goal is to use brain imaging to characterize the patterns of neural change induced by~     the intervention to identify brain structures that mediate therapeutic response.~   "
113617|NCT02080273|"~     The objective of this randomized, single center, parallel clinical research study is to~     evaluate the comparative efficacy performance of three dentifrices -Colgate Total Toothpaste,~     Parodontax Toothpaste and Colgate Cavity Protection Toothpaste in controlling gingivitis and~     dental plaque in adults.~   "
113618|NCT02080260|"~     This study tests regorafenib as a single agent in the treatment of metastatic pancreatic~     cancer patients who have progressed after prior chemotherapy with gemcitabine. The prognosis~     for these patients is particularly grim, no other standard treatment options exist, and novel~     approaches are desperately needed.~   "
113619|NCT02080247|"~     A randomized controlled trial that compared the use of two topical zinc oxide based diaper~     rash products in a structured care regimen for the treatment of IAD in hospitalized adults~     and older children.~   "
113620|NCT02080234|"~     To evaluate the efficacy and safety of first-line gemcitabine, oxaliplatin, and asparaginase~     (GELOX) with concurrent involved-field radiation therapy for patients in newly diagnosed~     stage IE/IIE ENKTL.~   "
113621|NCT02080221|"~     A standard treatment for your cancer is called FOLFIRINOX (this utilizes the FDA approved~     chemotherapy drugs fluorouracil, leucovorin, oxaliplatin and irinotecan). In this study you~     will receive the chemotherapy treatment FOLFOX-A (fluorouracil, oxaliplatin, leucovorin and~     Abraxane ®) which substitutes irinotecan for the FDA approved chemotherapy drug Abraxane ®.~     Even though Abraxane is FDA approved for pancreatic cancer, the combination of Abraxane with~     the other 3 drugs is being investigated. Your doctors are studying the activity and side~     effects of FOLFOX-A in advanced (metastatic) pancreatic cancer.~   "
113622|NCT02080208|"~     Patients with respiratory failure often need oxygen and/or ventilatory support. Patients who~     need only oxygen support, usually received low flow oxygen (< 15 Liters / min), as well as in~     respiratory weaning. Now new devices can be used. They provide high flow oxygen with~     different benefits. This high flow devices provide exact fraction of inspired oxygen (FiO2),~     allows a positive end expiratory pressure and supplies a wash out flow. The hypothesis of~     this study is that the high flow oxygen enable more efficient oxygen administration than~     conventional oxygen. In addition, it would improve the effectiveness of the ventilation of~     the patient, through flushing the dead space.~   "
113623|NCT02080195|"~     The main goal of the study is to determine if bone marrow transplant (BMT) from a less~     specific pool of donors in combination with high dose cyclophosphamide can induce remission~     of refractory systemic lupus erythematosus.~   "
113652|NCT02079818|"~     The primary objective of this study is to gather post market data on the Penumbra Ruby Coil~     System in the treatment of visceral artery aneurysms and arteriovenous malformations. This~     study is a prospective, multi-center study of patients with visceral artery aneurysms and~     visceral arteriovenous malformations who are treated by the Penumbra Ruby Coil System. Data~     for each patient are collected up to 12 months post-procedure for the study.~   "
113653|NCT02079805|"~     Multicenter, randomized, open-label, parallel-group exploratory study to explore the effects~     of azilsartan (Azirva), compared with telmisartan, on insulin resistance in participants with~     essential hypertension complicated by type 2 diabetes mellitus~   "
113624|NCT02080182|"~     In different studies, it has been shown that antioxidant utilization has favorable~     therapeutic effects not only on control of acute symptoms but also on prevention of delayed~     problems from acute and chronic pyelonephritis.~      According to the efficacy of acetylcysteine as a potent antioxidant, safety of this drug and~     side effects of similar or either less than placebo, this study was designed to evaluate the~     efficacy of this drug on inflammatory biomarkers of pediatric acute pyelonephritis. It is a~     triple-blind placebo controlled study on a population of 64 patients 1-16 years old that have~     definite or probable diagnosis of acute pyelonephritis in Mofid hospital.~      After randomization, patients will be given acetylcysteine or placebo with dosing according~     to their weight. Results of treatment are evaluated according to serum procalcitonin, C~     reactive protein and leukocyte count before drug prescription (baseline) and 5 days after~     drug prescription. Side effects are also recorded in both groups. Patients will be receiving~     their routine antimicrobial drugs in addition to acetylcysteine.~   "
113625|NCT02080169|"~     It is well known that ICU patients need sedation. Now no ideal sedation drug existed and~     every sedation drug has its advantage and disadvantage,so combined sedation may use the~     advantage and avoid the disadvantage of the sedation drug according to the~     patients'condition. Until now, there is rare study about the combined sedation or sequenced~     sedation of different sedation drug.The purpose of the study is to explore the value of~     combined sedation with midazolam and dexmedetomidine compared to single drug sedation in ICU,~     so as to seek an ideal sedation protocol that could reduce the cost of treatment,obtain the~     appropriate sedation not under sedation or over sedation,reduce the incidence of delirium,~     reduce the adverse event of sedation.~   "
113626|NCT02080156|"~     Investigators assume that continuous positive airway pressure (CPAP) therapy can reduce the~     mortality, stroke rate and secondary coronary surgery in CAD with obstructive sleep apnea~     (OSA) patients after percutaneous coronary intervention (PCI) or coronary artery bypass~     grafting (CABA) during postoperative follow-up of 3 years.~   "
113627|NCT02080143|"~     A disposable, air-activated, adhesive backed heat patch is being evaluated.~   "
113628|NCT02080130|"~     The purpose of this study is to determine which of two different preparations of probiotics~     is effective in the treatment of acute viral diarrhoea in children.~   "
113629|NCT02080117|"~     It is required to establish an adequate definition of delayed graft function in deceased~     donor kidney transplantation. We attempt to compare various definitions of delayed graft~     function and find the definition that can predict graft function survival best in deceased~     donor kidney transplantation.~   "
113630|NCT02080104|"~     Intramuscular versus intravenous prophylactic oxytocin for the third stage of labour~     following vaginal delivery: A randomised controlled trial~   "
113631|NCT02080091|"~     This observational study aims to assess the safety and effect of Iluvien® in DME patients~     considered insufficiently responsive to available therapies in a real life setting in~     Germany.~   "
113632|NCT02080078|"~     This study is to determine the use of theophylline in patients with NSCLC and advanced solid~     malignancies and whether treatment with theophylline will help lower or diminish the side~     effect of diarrhea in patients taking erlotinib. Patients will be enrolled in one of two~     parts of the study to verify the lowest dose of theophylline that is effective and the~     highest dose of erlotinib that can be tolerated with theophylline. If this study shows that~     theophylline is able to inhibit erlotinib induced diarrhea, it will help demonstrate that~     patients using the tyrosine kinase inhibitor (TKIs), erlotinib, can use it effectively at~     higher doses without experiencing severe diarrhea.~   "
113633|NCT02080065|"~     The incidence of acute kidney injury after liver transplantation has been reported to be 17~     to 95 percent, but no definite treatment has been reported yet. Therefore, it is important to~     identify and prevent reversible risk factors for acute kidney injury after liver~     transplantation. Previous studies have reported several preoperative clinical risk factors,~     but preoperative medication and intraoperative colloid administration and hemodynamic~     parameters have not been evaluated. Therefore, we attempt to evaluate perioperative risk~     factors and develop simplified clinical risk scoring model.~   "
113634|NCT02080052|"~     Prostate biopsies are commonly performed freehanded under transrectal ultrasound guidance~     (TRUS). Due to the manual approach and the limitations of the ultrasound imager, the~     procedure has high false-negative rates. This represents a daily problem for urologists~     managing the disease, creates uncertainty and emotional stress for patients, and initiates a~     cascade of repeat testing and biopsies which also burden the investigators healthcare system.~      The investigators believe that prostate biopsy can be improved by using a new biopsy~     paradigm. The investigators plan to perform MRI-guided prostate biopsies with~     robot-assistance for orienting a needle-guide through which the biopsy is taken. The~     combination of MRI and robotic precision is expected to improve prostate biopsy sensitivity~     compared to regular TRUS biopsies.~      The study is a Pilot clinical trial on 5 patients to primarily assess feasibility and safety.~     The needle-guide robot is an investigational device developed in their Urology Robotics~     Laboratory.~   "
113635|NCT02080039|"~     In this study the following hypotheses will be tested:~      Electrical stimulation of the gluteal muscle (buttocks) leads to~        1. an increase in the thickness of the gluteal muscle~        2. a decrease in the thickness of the fat of the buttock area~        3. a change in the distribution of the middle and maximal seating pressure to a more~          consistent pressure~        4. an increase in well-being of the patients.~   "
113636|NCT02080026|"~     Malaria, a disease caused by the parasite Plasmodium, is one of the world's major infectious~     diseases. With approximately 627.000 deaths a year, there is desperate need for an effective~     vaccine. Though a number of vaccine-candidates have been developed, they have yet to achieve~     the level of efficacy necessary to eliminate malaria. It has been shown previously that~     healthy human volunteers bitten by malaria-infected mosquitoes while taking chloroquine,~     medicine that prevents malaria, are fully protected against a subsequent malaria challenge.~     This is called CPS-immunization. The unprecedented effectiveness of CPS-immunization makes it~     a good model to identify what immune responses protect against malaria, to further guide~     vaccine development. In this study we will use CPS-immunization to induce protection against~     malaria in healthy subjects and then analyse their immune response to a malaria challenge~     infection.~   "
113637|NCT02080013|"~     our aim is to compare early outcomes following EVL 1320 nm and segmental RF in a randomized~     study.~   "
113640|NCT02079974|"~     Endometriosis is a chronic inflammatory disorder leading to painful periods, pain with~     intercourse and infertility. The available treatment options to alleviate pain involve mainly~     hormonal treatments and surgery. All current hormonal treatments are effective but disrupt~     the normal variations in reproductive hormones which prevent ovulation, and thus pregnancy.~     Statins, a group of cholesterol lowering drugs, have anti-inflammatory properties which may~     be helpful also for the pain related to endometriosis. The investigators plan to undertake a~     pilot study of 10 patients with endometriosis who will take pravastatin sodium together with~     coQ10, which is inhibited by statins, for a period of 3 months. If this pilot study shows~     that the statin treatment may decrease pain symptoms in endometriosis, then the investigators~     plan to undertake a larger study to further investigate this matter.~   "
113641|NCT02079961|"~     The study on dairy value chains that will be conducted in Northern Senegal tests whether a~     health-related product (micro-fortified yogurt) targeted to children can be provided through~     the logistics of an existing value chain, and whether in return this can be leveraged to~     enhance the reliability of producers supply within this value chain. This study is conducted~     with a local milk factory, a recently established social enterprise, striving to produce~     dairy products with the milk collected from several hundred semi-nomadic small-scale~     producers in northern Senegal. This study tests: (i) whether the logistic created to collect~     milk in a remote area can be leveraged to deliver fortified yogurts to infants within its~     suppliers households; (ii) whether such products effectively help improve the nutritional~     status (anemia) of these children; and (iii) whether these health services encourage~     suppliers (and in particular women) to increase their milk delivery to the milk factory.~   "
113642|NCT02079948|"~     This study will be the first to test whether a selected anti-inflammatory agent,~     methotrexate, reduces inflammation in a human body, improve cognitive and physical function,~     and reduce pain levels in older adults at risk for functional decline, due to systemic~     inflammation.~   "
113643|NCT02079935|"~     Eating disorders includes anorexia nervosa, bulimia nervosa, binge eating and other~     specified feeding or eating disorder (OSFED). Common to all is the intensively occupation to~     control food intake, body image and body weight. Most people with this kind of disorder don't~     reach for professional help, or there may be more than 4 years before they do. Cognitive~     behavior therapy is the foremost method of treatment of eating disorders, but up to 30-50% of~     the patients don't respond to this. The investigators find it important to identify science~     based alternatives of therapy, as this may reduce the health concern, and broaden the choice~     of therapy methods. A former study by Sundgot-Borgen et al in 2002, found guided physical~     activity to reduce symptoms of bulimia nervosa just as good as the traditional cognitive~     therapy.~      The primary objective of the project is to see whether the combination of physical exercise~     and dietary therapy is more effective in treating eating disorders, than cognitive therapy.~      Secondly, the investigators want to see whether there are any differences with regard to the~     individual satisfaction of treatment method, and to associated costs. Interviews with a~     sufficient number of participants from the PED-t arm to meet data saturation criteria, and~     all theraphists in the new treatment offer, will give uniqe insight to experiences with the~     treatment method and the delivery of treatment.~   "
113644|NCT02079922|"~     PF-06678552 is a new compound proposed for the treatment of hypercholesteremia. The primary~     purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and~     pharmacodynamics of multiple oral doses of PF-06678552 in healthy subjects.~   "
113645|NCT02079909|"~     The primary objective is to evaluate the efficacy of T-817MA as measured by ADAS-cog and~     ADCS-CGIC.~      The secondary objectives are:~        -  To evaluate the safety and tolerability of T-817MA measured by clinical safety~          laboratories, physical examinations, ECGs and solicitation of adverse events.~        -  To evaluate the efficacy of T-817MA as measured by ADCS-ADL, FAQ, Neuropsychiatric~          Inventory (NPI) and Mini-mental State Examination (MMSE).~   "
113646|NCT02079896|"~     Dialysis patients regularly suffer from anemia which may be caused by various contributing~     factors, alone or in combination, including blood loss, low erythropoietin and iron~     sequestration. In most patients, the anemia is responsive to treatment with erythropoietin or~     other erythropoiesis stimulating agents (ESA) alone or in combination with intravenous (i.v.)~     iron. In about 10% of patients however, the anaemia does not respond appropriately to this~     standard treatment and high to very high doses of ESA and i.v. iron are used to maintain~     acceptable hemoglobin concentrations. In these patients, hepcidin was identified as a~     causative factor leading to anemia of chronic disease with functional iron deficiency and~     ESA-hyporesponsiveness.~      The Spiegelmer lexaptepid pegol (NOX-H94) offers a hepcidin-specific approach to the~     treatment of anemia of chronic disease. The safety and the activity of lexaptepid pegol are~     supported by data from healthy subjects and patients with multiple myeloma or lymphoma. The~     present study in dialysis patients with functional iron deficiency and ESA-hyporesponsiveness~     is conducted to demonstrate the safety of lexaptepid pegol in this population, to investigate~     its pharmacokinetic (PK) and pharmacodynamic (PD) profiles and its efficacy in increasing~     haemoglobin (Hb) in dialysis patients.~   "
113647|NCT02079883|"~     This is a multicenter, prospective, observational, Phase 4 study that will assess clinical~     outcomes and safety of JETREA® administered in a real-world setting for the treatment of~     symptomatic vitreomacular adhesion (VMA) by assessing anatomical and functional outcomes in~     1500 patients recruited across approximately 120 USA retina sites.~   "
113648|NCT02079870|"~     This trial is conducted in Europe. The aim of the trial is to investigate the effect of~     semaglutide on energy intake, appetite sensations, postprandial glucose and triglyceride~     metabolism and gastric emptying in obese subjects compared with placebo.~   "
113649|NCT02079857|"~     The objective of this study is to test the efficacy of a symptom management treatment~     strategy, Acupuncture/Moxibustion (Acu/Moxa), to improve the symptoms associated with~     Irritable Bowel Syndrome (IBS) in adults.~   "
113650|NCT02079844|"~     The purpose of this study is to determine whether cognitive impairment associated with~     schizophrenia is attenuated by add-on roflumilast administration to second generation~     antipsychotics (SGA) in participants with stable schizophrenia.~   "
113665|NCT02079649|"~     The purpose of this study is to evaluate two investigational ophthalmic solutions for~     reduction in ocular redness in subjects with allergic conjunctivitis.~   "
113654|NCT02079792|"~     Chronic Rhinosinusitis (CRS) is a common disorder of the nose characterized by stuffy nose,~     discoloured nasal discharge, sinus congestion or pressure and decreased sense of smell,~     present for over twelve weeks. Anti-inflammatory steroid medication is often used to treat~     sinus inflammation in CRS. These steroids are sometimes delivered using a spray device that~     creates a mist to deliver steroid medication deep into the nose. However, the distribution~     and efficacy of sprayed medication can be affected by the position of the patient's head.~     This study aims to determine which of two head positions is best for delivering steroid to~     the sinuses.~   "
113655|NCT02079779|"~     Stroke is the principal cause of permanent disability within the investigators population.~     This incapacity justifies an intensive and prolonged multidisciplinary rehabilitation, which~     can be optimized by robotics.~      The investigators team has developed a robot designed to rehabilitate the upper limb. This~     robot allows the patient to perform active, passive, or assisted exercises. The system is~     also able to assess movement quality and to provide a feedback to the patient and the~     therapist via a graphical interface. This therapy is designed to improve functional recovery~     of patients, and then their quality of life.~      Few quality studies have evaluated the efficacy of robotic assisted therapy in patients at~     the acute stage of rehabilitation (< 3 months post stroke) when most improvements are~     observed.~      Thus, the aim of this study was to objectify the effectiveness of robotic-assisted~     rehabilitation in the acute stage after stroke by evaluating the 3 fields of the ICF~     (International Classification of Functioning, Disability and Health) and performing a~     prospective multicenter randomized controlled single blind trial. In this study, 60 stroke~     patients will be recruited and randomized into two groups. All patients will receive a~     similar classical rehabilitation as a basis. Patients of the control and experimental groups~     will receive a supplement of classical rehabilitation and robotic-assisted therapy,~     respectively.~   "
113656|NCT02079766|"~     This study will explore the use of 18F-AV-1451 as a biomarker for chronic traumatic~     encephalopathy (CTE) and examine the relationship between clinical presentation and tau~     deposition.~   "
113657|NCT02079753|"~     Introduction: Portable oxygen devices simplify and facilitate patient therapy. This study was~     designed to compare oxygen saturation and patient satisfaction with a portable oxygen~     concentrator or with a combined system consisting of a fixed device with continuous flow~     oxygen dispensation and a portable device with pulse dispensation for ambulation.~      Methods: This cross-over trial assessed 25 patients with COPD (92% men; mean age 72.2 ± 7.4~     years; mean FEV 34.14 ± 12.51%) at four hospitals in Madrid. All patients had previously used~     the combined system, consisting of a fixed oxygenation system and a portable system for~     ambulation, with 16 (64%) using stationary and portable concentrators and 9 (36%) using a~     stationary reservoir and portable liquid oxygen bag. Oxygenation settings at rest and while~     walking were determined at baseline. Patients were maintained on the previous combined system~     for one week and then switched to the portable oxygen concentrator for one week. Mean SpO2~     over 24 hours was calculated by the software in the oximeter, and compliance was monitored~   "
113658|NCT02079740|"~     This phase Ib/II trial studies the side effects and best dose of trametinib and navitoclax~     and how well they work in treating patients with solid tumors that have spread to other~     places in the body. Trametinib and navitoclax may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth.~   "
113659|NCT02079727|"~     The purpose of this study is to confirm the efficacy and safety of 800 mg Chondroitin 4&6~     sulfate (Condrosulf) vs placebo once a day for 6 months in the symptomatic treatment of knee~     osteoarthritis. A third group, Celecoxib 200 mg (Celebrex) once a day, will be used as active~     comparator.~   "
113660|NCT02079714|"~     The STREAM Study is a prospective longitudinal observational outcomes study that will examine~     the reliability, validity and responsiveness of the PROMIS tools for clinical research~     following orthopaedic trauma.~   "
113661|NCT02079701|"~     The primary objective is to determine the clinical benefit of employing the 23-valent~     pneumococcal vaccine among US military trainees. Secondary objectives include:~        -  determining the etiology of clinical pneumonia among U.S. military trainees;~        -  comparing the serotype distribution of S. pneumoniae (Sp) isolates recovered from~          vaccinated and nonvaccinated trainees diagnosed with pneumonia; and~        -  comparing days lost from training due to pneumonia or acute respiratory disease for~          vaccinated and nonvaccinated subjects.~   "
113662|NCT02079688|"~     Atopic dermatitis (AD) is a chronic or chronic recurring inflammatory skin disorder. Patients~     suffer from eczema and often severe pruritus on the affected skin, as well as from frequent~     complications and secondary infections. Next to a genetically predetermined defect in~     epidermal barrier function and vegetative dysfunction, AD arises from an upregulation of~     Th2-modified immune responses inducing increased IgE-antibody production, cytokine secretion~     and subsequently, local inflammation.~      Although standard therapies of AD, modern topical corticosteroids, show a better ratio of~     therapeutic effects to side effects, they retain a moderate acceptance due to their~     non-specific action, strict compliance requirements and possible adverse effects. As a newer~     alternative, calcineurin inhibitors show fewer side effects but raise concerns regarding long~     term risks including the possibility of skin carcinogenicity. Therefore, medical need remains~     for novel therapies for this major public health problem, directed in particular at specific~     early disease-causing mechanisms and/or molecular targets, with an improved efficacy, safety~     and compliance.~      Novel therapeutic strategies for the treatment of chronic inflammatory diseases by targeting~     early disease-causing mechanisms are a promising approach for the treatment of AD.~      The transcription factor GATA-3 represents the key regulatory factor of Th2-driven immune~     responses. It is indispensable for the differentiation and activation of Th2 cells; it~     integrates Th2 signals and induces Th2 cytokine expression. The investigational product SB011~     contains the DNAzyme hgd40 that targets GATA-3. By cleaving GATA-3 mRNA hgd40 reduces~     specific cytokine production and thereby reduces key features of allergic airway~     inflammation.~      DNAzymes are completely generated by chemical synthesis and can be produced under Good~     Manufacturing Practice (GMP) controlled conditions. The DNAzymes are not biological drugs,~     i.e. they are not generated by use of any living organism including cell culture or bacteria.~     The molecules are highly water-soluble and will be applied as a water/oil/water (W/O/W)~     formulation since multiple emulsions have been shown to protect the active ingredient from~     degradation on the skin and have penetration enhancing properties in comparison to other~     carrier systems.~      This proof-of-concept study will evaluate the efficacy, safety, tolerability,~     pharmacokinetics (PK), and pharmacodynamics (PD) of the topical formulation SB011 containing~     2 % hgd40 twice daily (BID) in patients with mild to moderate atopic eczema.~   "
113663|NCT02079675|"~     The purpose of this study is to determine the efficacy and safety of different doses of~     SKI3246 compared with placebo in the treatment of patients with irritable bowel syndrome with~     non-constipation.~   "
113664|NCT02079662|"~     The goal of this behavioral research study is to look at the relationship between lifestyle~     factors and cancer-related outcomes, such as the risk of the disease coming back, patient~     quality of life, physical functioning, and bodily reactions (such as hormones and immune~     function).~   "
113666|NCT02079636|"~     The main purpose of this study is to evaluate the safety and tolerability of abemaciclib in~     combination with another anti-cancer drug in participants with NSCLC that is advanced or has~     spread to other parts of the body (stage IV). The study will also investigate how the body~     processes the combination treatment and how the study drug affects the body. The study will~     also collect disease-related symptoms and participant-reported pain related to NSCLC.~   "
113667|NCT02079623|"~     The aim for this study is to implement electroporation therapy (NanoKnife) treatment for~     patients with locally advanced pancreatic cancer. Electroporation therapy (NanoKnife) will be~     given in addition to standard chemotherapy.~   "
113668|NCT02079610|"~     The purpose of this study is to determine whether upregulating the left amygdala during~     positive autobiographical memory recall via real time functional magnetic resonance imaging~     neurofeedback will lead to an improvement in clinician administered ratings of depressive~     symptoms. The investigators predict that patients with major depressive disorder receiving~     left amygdala neurofeedback will increase their amygdala response during positive~     autobiographical memory recall compared to those receiving control feedback from a region not~     involved in emotional processing and that this ability will be associated with clinically~     significant improvement.~   "
113669|NCT02079597|"~     -  With the underlying study the investigators address the question if Ninjurin-1 (Ninj1)~          expression is altered in patients with systemic inflammatory response syndrome (SIRS) in~          comparison to healthy volunteers.~        -  The adhesion molecule Ninj1 is induced following nerve injury where it contributes to~          nerve generation. Besides it is described to facilitate leukocyte migration especially~          in the nervous system.~        -  The investigators hypothesize that Ninj1 expression is increased in SIRS patients, which~          will fortify its impact during inflammation and the transferability from bench to~          bedside.~   "
113670|NCT02079584|"~     The objectives of this registry are to measure the outcomes, cost, adherence pattern and~     experience of patients treated as outpatients with rivaroxaban after being diagnosed with~     blood clots in the emergency department. The investigators hypothesize that patients will~     have a relatively low rate of adverse events and higher adherence than has been reported~     historically for warfarin treatment. Patients will be scheduled for follow up care with one~     of Dr. Kline's Outpatient Thrombosis clinics at Methodist Hospital or Eskenazi Health~     Services after diagnosis and treatment of pulmonary embolism (PE) or deep vein thrombosis~     (DVT). The investigators will collect information for a registry and a database will be~     developed and blood specimens will be obtained at each follow up visit for analysis and~     storage for possible use related to this treatment and research or study at a later date.~     Questionnaires will be administered to collect variables that the investigators hypothesize~     to be important to understand the causes of non-adherence. To better quantify the economic~     impact, the investigators will also perform a cost effectiveness analysis with no comparator,~     meaning the investigators will tabulate the cost of care for each patient enrolled using~     variable costs from a UB92 report for each patient.~   "
113671|NCT02079571|"~     In traditional Chinese medicine (TCM), hot- and cold-attribute of food ingredients are a~     major part of dietary therapy. Eight Principles including cold/hot, repletion/vacuity,~     yin/yang and exterior/interior are used for diagnose by Chinese medical doctors. From the~     perspective of TCM, all constitutions, diseases, herbal medicine and foods can be divided~     into these two major categories, i.e., cold and hot. Therefore, dietary therapy claims that~     the attributes of foods should be used to oppose our constitutions in order to harmonize~     organ functions and maintain human vitality. The true benefit of dietary therapy is~     considered to be the reestablishment of a harmonious balance between cold and hot, or~     repletion and vacuity, within the human body.~      Previous studies reported that the capillary red blood cell (RBC) velocity in nail fold~     microcirculation (NFM) of the subjects with hot constitution accelerated significantly after~     taking the hot attribute aged ginger tea, which might be the result of elevated vagal~     activity leading to arteriole dilation in these subjects. In contrast, in subjects with cold~     constitution, capillary RBC velocity decelerated significantly and skin temperature decreased~     markedly after taking the cold-attribute coconut water, which might have been induced by~     sympathetic nerve activation causing the arteriole to be constricted. As a result, the use of~     capillary RBC velocity of NFM measured by laser Doppler anemometer may be a promising way to~     classify attributes of food ingredients commonly used in Chinese medicine dietary therapy in~     accordance with different personal constitutions.~      Accordingly, it will be a worthwhile task to establish a modern scientific methodology to~     define the attributes of food ingredients. The aim of this project is to investigate the~     relationship between food attributes and the physiological signals produced in healthy young~     subjects with different constitutions. In the first year of this project, investigators are~     starting to determine the pulse waves produced in healthy subjects with different~     constitutions by a Smart Pulse Wave Health Evaluation System (S-PULSE). Then, investigators~     will investigate the relationship between food attributes, channel entries and the~     physiological signals. Hopefully, the results will have a leverage on the powerful~     integration capacity within National Taiwan University (NTU) campus to build a hub for global~     TCM cloud.~   "
113672|NCT02079558|"~     Postpartum hemorrhage (PPH) is a common complication of childbirth and a leading cause of~     maternal morbidity and mortality. The prompt and effective treatment of subjects with PPH~     would reduce operation risks. Hence in this study, the efficacy of Oxytocin and Carbetocin~     was compared in prevention of postpartum hemorrhage after cesarean sections.~   "
113673|NCT02079545|"~     The purpose of the study is to assess the bioavailability (the extent to which a medication~     becomes available to the body) of subcutaneously (under the skin using a needle) administered~     sirukumab and to compare the pharmacokinetics of sirukumab administered subcutaneously using~     a pre-filled syringe fitted with the UltraSafe Passive™ Delivery system (PFS-U) with the~     SmartJect™ Autoinjector (PFS-AI) in healthy male participants.~   "
113674|NCT02079532|"~     This study will evaluate the efficacy and safety of MabThera in patients with active~     rheumatoid arthritis who have had an inadequate response to one prior anti-TNF alpha~     inhibitor. MabThera-naive patients will be stratified into 3 arms, according to previous~     inadequate response to a)etanercept, b)infliximab or c)adalimumab. Patients will be treated~     with MabThera (1g infusion) on day 1 and day 15, and will continue their basic methotrexate~     therapy. The anticipated time on study treatment is 2+ years, and the target sample size is~     100-500 individuals.~   "
113675|NCT02079519|"~     This study evaluated the efficacy and safety of Avastin (bevacizumab, 5 mg/kg intravenously~     every 2 weeks) in patients with multiple myeloma, relapsed/refractory after at least 2 lines~     of prior therapy.~   "
113676|NCT02079506|"~     The objective of this study is to compare pharmacokinetics after single oral administration~     of candesartan and rosuvastatin each separately versus coadministration of candesartan and~     rosuvastatin in healthy male volunteers.~   "
113677|NCT02079493|"~     The purpose of this study is to obtain patient-oriented and clinically-oriented physical~     function outcomes both pre-operatively and post-operatively in patients receiving a total~     knee arthroplasty .~   "
113680|NCT02079454|"~     Research aimed to find a correlation with an invos drop and cardiac events in the~     peri-operative period of non cardiac surgery.~      The investigators postulate that a drop in the Invos numbers (with or without significant~     drop in BP) is associated with a variable degree of cardiac suffering.~      The idea is to prevent per and foremostpost-operative myocardial necrosis complications by~     acting as soon as we have an INVOS drop during anesthesia.~      The cardiac events will be monitored and defined according to the EHA (european heart~     association) guidelines.~      (Changes of the EKG and/or troponin I values above the threshold). Patient will be monitored~     per and post operatively.~   "
113681|NCT02079441|"~     1. To evaluate the immune response to vaccines in infants of IBD patients treated with~          anti-TNF medications during pregnancy compared to infants of IBD mother not treated with~          anti-TNF medications.~        2. To evaluate the immune function of B and T cells at 3 months and one year of age in~          infants of IBD patients treated with anti-TNF medications during pregnancy compared to~          infants of non anti-TNF treated mothers.~      The secondary aims are to follow anti TNF drug levels in infants born to IBD patients treated~     with anti-TNF medications during pregnancy and to evaluate the risk of infections during the~     first year of life in this population, compared to children of IBD patients not treated with~     anti-TNF medications during pregnancy.~      Significance -The results of this study have the potential to change clinical practice of~     anti TNF treatment during pregnancy and the follow-up of infants born to these patients~   "
113682|NCT02079428|"~     The purpose of CN-HF is to establish the national registration of hospitalized heart failure~     patients, evaluate and compare the clinical features and prognosis of diastolic and systolic~     heart failure, and find out the status of treatment and implementation of guidelines on heart~     failure in China.~   "
113683|NCT02079415|"~     Saudi Arabia has been named by the International Diabetes Federation as among the top ten~     countries with highest prevalence of diabetes. Women are said to have overall prevalence~     twice that for men. With high birth rate in the country we decided to look at the impact of~     diabetic pregnancies on their off-springs~   "
113684|NCT02079402|"~     The purpose of this trial is to o assess feasibility of a protocol comparing conservative~     (trigger guided) vs. liberal (target guided) approach to fluid resuscitation in patients with~     septic shock after initial fluid resuscitation.~   "
113685|NCT02079389|"~     The following project deals with a Danish multicenter trial that evaluates the value of~     Laparoscopic Ultrasound examination (LUS) in laparoscopic surgery for colon and rectum cancer~     (CRC).~      The project The value of laparoscopic ultrasound in patients undergoing laparoscopic~     resection for colon and rectum cancer. - A prospective randomized trial is part of a ph.d-~     study at the University of Southern Denmark in collaboration with several surgical~     departments at hospitals in Southern Denmark.~      The primary purpose is to investigate whether the use of laparoscopic ultrasound examination~     (LUS) will change the stage of the tumor, lymph node and metastasis (TNM stage) and the~     surgical approach in patients undergoing laparoscopic surgery for colorectal cancer (CRC).~      As a secondary objective; an evaluation of the use of LUS will change the treatment strategy~     for the individual patient with CRC.~      As an other objective we wants to investigate whether the use of contrast enhanced ultrasound~     examination in connection with LUS procedure increases the number of detected liver~     metastases.~   "
113686|NCT02079376|"~     Study to evaluate the efficacy of gastric stimulation (GCM) using the DIAMOND System in the~     improvement of glycemic control measured by changes in HbA1c.~      Relationship between blood TG level and the GCM efficacy will be evaluated.~   "
113687|NCT02079363|"~     The objectives of this project are to test whether alteration in DNA hypermethylation in~     plasma is:~        -  a diagnostic marker for pancreatic cancer~        -  a prognostic marker for pancreatic cancer~        -  a marker for recurrence of pancreatic cancer~        -  changing during the course of chronic pancreatitis, with the purpose of finding patients~          with high risk of developing pancreatic cancer~   "
113688|NCT02079350|"~     Although the negative impacts of colloid solutions with high molecular weight on renal~     functions, combination of lower molecular weight colloid varieties with crystalloid solutions~     and its use during intraoperative period have been subject to current research. Since the~     first liver transplantation, pre-or post-transplantation renal problems are still among the~     main causes of mortality and morbidity. The aim of the study was to evaluate the effects of~     fluid replacement solutions used intraoperatively on renal functions in elective living-donor~     liver transplantation.This study was approved by the Ethics Committee of Hospital and all~     patients were informed and gave written consent. Participants were patients scheduled for~     elective living-donor liver transplantation. Patients with normal renal function were~     randomly allocated to infusion with 6% HES 130/0.4 (HES Group) and 4% Gelofusine (GEL Group).~     Blood samples were obtained before induction of anesthesia (baseline), at the end of the~     operation, and postoperative days 1 and 4. Different eGFR formulas using creatinine (MDRD,~     CKD-EPI, and Cockraud Gault) were used to calculate estimated glomerular filtration rates.~   "
113689|NCT02079337|"~     Use of neuromuscular blockade (NMB) may improve the surgical work space in patients scheduled~     for laparoscopic surgical cases (e.g. hysterectomy, ovarian cystectomy, myomectomy). Clinical~     studies investigating this question often use a numerical or verbal rating scale for~     subjective evaluation of the surgical workspace. However, no good subjective rating scale~     have been developed or validated. Neither have possible inter-individual differences in use~     of such subjective scales been described.~      Purpose:~      The aim of this study is to validate different subjective rating scales to determine which~     scale is most useful among surgeons.~   "
113690|NCT02079324|"~     The purpose of this research is to evaluate MTD, Safety and efficacy of GX-051 after~     intratumoral injection in head and neck cancer patience.~   "
113703|NCT02079155|"~     This randomized clinical trial compares a recently developed technique, called robotic~     laparoendoscopic single-site radical prostatectomy (R-LESS RP), to the current standard of~     robotic technique for prostate cancer, robot-assisted laparoscopic prostatectomy (RALP) in~     treating patients with newly diagnosed, locally confined prostate cancer. Both procedures are~     types of robotic radical prostatectomy, or the robot-assisted removal of the prostate though~     a small incision in the belly. In the standard approach, 4-5 small (1-2 cm) incisions are~     made in the lower abdomen to allow the insertion of robotic instruments. In the R-LESS~     technique, all instruments are inserted through a single incision. R-LESS RP is less invasive~     than RALP and may leave a smaller scar and cause less pain.~   "
113691|NCT02079311|"~     This investigation is undertaken to investigate if patient warming with BARRIER® EasyWarm~     active self-warming blanket differs compared to active warming with forced air warming in~     terms of core body temperature perioperatively.~      A non-inferiority, prospective, open-labelled, randomized, parallel investigation.~      Randomized subjects will receive active warming with BARRIER® EasyWarm or with forced air~     warming. All subjects may receive rescue warming if their core temperature falls below~     35.5°C. Rescue warming is optional and defined as the institution's standard of care to~     prevent hypothermia.~      The primary purpose is to investigate if there is a clinically relevant difference in core~     body temperature between the two treatment groups.~      A total of 60 subjects will be included in the investigation, i.e. 30 subjects in each~     treatment group. The number includes a 30% drop-out rate.~   "
113692|NCT02079298|"~     This study will investigate pharmacological interventions between fluconazole and ibuprofen~     when they are given to premature newborn babys. This in order to find out if the drugs are~     influencing each other when they are given at the same time. The study is meant to find out~     if there are reasons to adjust the dose when fluconazole and ibuprofen are given together.~   "
113693|NCT02079285|"~     <Background/aims> Rapid onsite evaluation (ROSE) of endoscopic ultrasound-guided fine needle~     aspiration and biopsy (EUS-FNAB) specimens by attending cytopathologists has been~     demonstrated to improve diagnostic yields of EUS-FNAB. The practice of ROSE, however, varies~     across EUS programs in Unites States, Europe and other areas of world. The investigators have~     a plan to perform prospective evaluation of the yield of EUS-FNAB in the absence of ROSE, in~     which the adequacy of specimens will be assessed by a single endosonographer.~      <Methods> All EUS-FNAB procedures will be performed by an experienced endosonographer and the~     adequacy of specimens obtained during EUS-FNAB will be also assessed by a same~     endosonographer. A specimen will be considered adequate if there is an adequate number of~     representative cells from the lesion. Samples considered to be adequate will be then~     interpreted as malignancy, highly atypical suggestive of malignancy, atypical favor reactive~     change, or negative for malignancy. Performance characteristics of EUS-FNAB including~     sensitivity, specificity, and accuracy will be determined by comparing EUS-FNAB results with~     the final diagnoses of the lesions, based upon the surgical pathology or clinical follow-up~     of more than 6 months with repeat imagings.~   "
113694|NCT02079272|"~     The purpose of this study is to determine whether a new technique of radiotherapy for breast~     cancer (helical tomotherapy) can induce cardiac toxicity that would be detected in the first~     two years after treatment. Screening of subclinical cardiac lesions with non-invasive cardiac~     imaging techniques combined with measures of circulating biomarkers of cardiac tissue lesions~     and coronary lesions would allow assessing radiation-induced cardiac toxicity at an early~     stage.~   "
113695|NCT02079259|"~     The number of patients with acute congestion on chronic heart failure is increasing.~     Ultrafiltration has recently been proposed as an alternative approach for the stabilization~     of volume balance, especially in patients with imminent diuretic resistance.~      There is increasing evidence that ultrafiltration may relief cardiac congestion with lesser~     effects on blood pressure and activation of renin angiotensin system, respectively . However,~     recent studies revealed conflicting results: demonstration the superiority of ultrafiltration~     in comparison to diuretic treatment, and a lack of evidence of benefit, as well as an excess~     of adverse events with ultrafiltration.~      Aquapheresis with adapted ultrafiltration rate guided by central venous pressure is safer~     than aquaphesis with a constant ultrafiltration with comparable effectiveness~   "
113696|NCT02079246|"~     To evaluate the long-term safety and tolerability of idalopirdine (Lu AE58054) as adjunctive~     therapy to donepezil in patients with mild-moderate Alzheimer's Disease (AD).~   "
113697|NCT02079233|"~     This is a study to determine the effect of four different dosing regimens of CLP in normal~     healthy volunteers.~   "
113698|NCT02079220|"~     This is an open label, two-arm, phase II trial to evaluate the anti-tumor activity, safety,~     and tolerability of ziv-aflibercept in combination with XELOX chemotherapy in the first-line~     treatment of subjects with mCRC.~      Two different schedules of ziv-aflibercept in combination with XELOX will be evaluated in~     this study: every 2 week schedule (Arm A) and the every 3 week schedule (Arm B). The choice~     between arm A and arm B will depend on the investigator's preference.~      Arm A (every 2 week schedule) Dosage and dosage regimen for all study periods~        -  Capecitabine: will be administered 1,000 mg/m2 orally twice a day on Days 1 - 7 of each~          cycle, repeating every 14 days.~        -  Oxaliplatin: will be administered 85 mg/m2 IV on Day 1 of each cycle, repeating every 14~          days.~        -  Ziv-aflibercept: will be administered 4 mg/kg IV on Day 1 of each cycle, repeating every~          14 days.~      Arm B (every 3 week schedule):~      Dosage and dosage regimen for all study periods~        -  Capecitabine: will be administered 850 mg/m2 orally twice a day on Days 1 - 14 of each~          cycle, repeating every 21 days.~        -  Oxaliplatin: will be administered 130 mg/m2 IV on Day 1 of each cycle, repeating every~          21 days.~        -  Ziv-aflibercept: will be administered 6 mg/kg IV on Day 1 of each cycle, repeating every~          21 days.~   "
113699|NCT02079207|"~     This study will assess the Immunogenicity and safety of 13-valent Pneumococcal Conjugate~     Vaccine compared with 23-valent Pneumococcal Polysaccharide Vaccine. All participants should~     be naïve of Pneumococcal vaccine.~   "
113700|NCT02079194|"~     To compare the efficacy and safety of clopidogrel monotherapy versus aspirin plus P2Y12~     antagonist following 3-month of DAPT in patients undergoing PCI with DES.~   "
113701|NCT02079181|"~     This clinical trial studies the safety and drug distribution of the radioactive drug,~     2'-deoxy-2'-[18F]fluoro-5-methyl-1-beta-D-arabinofuranosyluracil (fluorine F 18 d-FMAU~     [18F-FMAU]), for imaging with positron emission tomography/computed tomography (PET/CT) in~     patients with advanced cancers. A PET scan is a procedure in which a small amount of~     radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed,~     computerized pictures of areas inside the body where the glucose is taken up. Because cancer~     cells often take up more glucose than normal cells, the pictures can be used to find cancer~     cells in the body. PET/CT using the drug fluorine F 18 d-FMAU, may help find cancer and find~     out how far the disease has spread.~   "
113702|NCT02079168|"~     To evaluate the effectiveness of RXI-109 in reducing the recurrence of keloid formation~     following elective keloid excision.~   "
113704|NCT02079142|"~     The purpose of this study is to evaluate two training methods of IPT with mental health~     service providers in college counseling centers.~   "
113707|NCT02079103|"~     Background: High intensity training of challenging tasks with many repetitions is a key~     factor for regaining motor function after stroke. Novel virtual reality (VR) rehabilitation~     systems provide the potential to increase intensity and offer challenging and motivating~     tasks. The efficacy of VR systems has not been demonstrated yet in sufficiently powered~     studies.~      Methods: In 5 participating rehabilitation centers patients in the subacute phase after~     stroke will be randomized to either a group receiving 4 weeks of VR training in addition to~     conventional arm training or a group receiving dose-matched and therapist attention-matched~     conventional arm-training.~      Hypothesis: VR training is more effective in improving arm motor function than conventional~     arm training in the subacute phase after stroke.~   "
113708|NCT02079090|"~     Sedation and pain medication is required when bone fractures need to be fixed in the~     emergency department (ED). Many drugs have been used safely as single agents or in~     combination for the sedation of children. These drugs include Propofol, Ketamine and~     Fentanyl. However each of these medications has side effects and drawbacks. The combination~     of Propofol and Fentanyl (Fentofol) has never been compared directly with the combination of~     Propofol and Ketamine (Ketofol) for painful procedures in the ED, and the goal of this study~     is to determine which combination works better. The primary outcome of this study is to~     determine which drug combination has a shorter time from onset of sedation to full recovery.~     The investigators hypothesize that Fentofol will have shorter sedation to recovery times.~   "
113709|NCT02079077|"~     In this project, the investigators want to analyse the capacity of Acetylsalicylic acid and~     hydoxychlroquin (HCQ) to induce an Immune Quiescence (IQ) phenotype, which has been~     previously associated with natural protection to HIV infection. This phenotype is~     characterized by lower expression of genes involved in cellular activation, lower resting~     levels of inflammatory cytokine production, lower level of systemic activated T cells,~     increased levels of systemic T regulatory, increased production of anti-viral anti-protease~     serpins at the female genital tract and reduced numbers of HIV target cells (mainly CD4+~     CCR5+ T cells) in the FGT ( female genital tract).~      The objective of this study is to determine if daily oral administration of Acetylsalicylic~     acid or hydroxychlroroquin can reduce systemic and mucosal immune activation in HIV negative~     women.~   "
113710|NCT02079064|"~     The aim of this prospective randomized study is to evaluate the perioperative effects of~     inhalational anesthesia (desflurane) and intravenous anesthesia (propofol) on hemostasis in~     patients undergoing splenectomy with liver cirrhosis guided by the new technology (ROTEM) and~     the traditional laboratory hemostatic markers.~   "
113711|NCT02079051|"~     We are proposing a trial to directly compare a high intensity weight loss protocol to a~     moderate intensity weight loss protocol to determine which leads to greater improvements in~     physical function in severely obese older adults.~   "
113712|NCT02079038|"~     The purpose of this study is to determine safety and effectiveness, as measured by changes in~     pain, disability, patient satisfaction, and claudicatory symptoms, at 6 months following~     treatment with the Totalis™ Direct Decompression System or Sham Surgery in patients with~     lumbar spinal stenosis~   "
113713|NCT02079025|"~     This trial uses a ultra high-resolution ultrasound system and specialized transducer,~     intended for use in prostate imaging. The system's image resolution is significantly better~     than the standard of care, due to its higher frequency. This allows the system to visualize~     suspicious areas and structures, and for greater accuracy for guided biopsy.~      The primary objective of this study is to demonstrate that ultra high-resolution transrectal~     ultrasound (UHR-TRUS) is superior to conventional low-resolution transrectal ultrasound~     (LR-TRUS) in detecting clinically significant cancer among men without known prostate cancer~     and with an indication for prostate biopsy.~      The secondary objective of this study is to compare the difference in the rate of detection~     of clinically significant cancer between LR-TRUS and UHR-TRUS, from before investigator~     training to after investigator training.~      The tertiary objective for the investigation is to compare the combined sensitivity and~     specificity in determining cancer detection overall for image-guided biopsy in UHR-TRUS vs.~     LR-TRUS.~   "
113714|NCT02079012|"~     The purpose of this study is to investigate the short- and long-term effects of a 10-week~     walking program, based on the self-determination theory, in people with mental disorders. The~     investigators expect positive effects on:~        -  Physical fitness~        -  Physical activity~        -  Well-being (less feelings of anxiety, less feelings of depression) The investigators~          also expect underlying psychosocial processes to influence these effects.~   "
113715|NCT02078999|"~     To evaluate in a cohort of patients on mechanical ventilation, for non-infectious reasons and~     for documented sepsis of pulmonary as well as non-pulmonary origin, the bacterial load,~     procalcitonine (PCT), C-Reactive Protein (CRP), temperature, White cell count (WCC), American~     College of Chest Physicians/Society of Critical Care Medicine (ACCP/SCCM) consensus~     conference criteria, Sequential Organ Failure Assessment score (SOFA) and simplified Clinical~     Pulmonary Infection Score (CPIS) through the mechanical ventilation period~   "
113716|NCT02078986|"~     The main aim of the study is to determine the effects of Whole-Body Electromyostimulation~     (WB-EMS) on body composition and muscle strength compared with the golden standard High~     Intensity Resistance Exercise Training (HIT) in healthy sedentary middle aged males.~   "
113717|NCT02078973|"~     Tolvaptan is a selective vasopressin receptor antagonist (V2R) that increases free water and~     sodium excretion. Inhibition of V2R increases vasopressin concentration in plasma, which~     stimulates V1-receptors in the vascular bed and may change both central and brachial~     hemodynamics and plasma concentration of vasoactive hormones.~      The purpose of the study is to measure the effects of tolvaptan on renal handling of water~     and sodium, systemic hemodynamics and vasoactive hormones at baseline and during nitric oxide~     (NO)-inhibition with L-NG-monomethyl-arginine (L-NMMA).~   "
113718|NCT02078960|"~     To satisfy a postmarketing requirement, the sponsor has been requested to conduct a Phase~     1/Phase 2 single-group clinical study to investigate the pharmacokinetics and preliminary~     safety and efficacy of omacetaxine following a fixed-dose administration to patients with CP~     or AP CML who have failed 2 or more tyrosine kinase inhibitor (TKI) therapies.~   "
113818|NCT02077660|"~     The purpose of this study is to evaluate the beneficial effects of a long term (12 weeks)~     green tea drinking on plasma, erythrocytes and saliva oxidative stress biomarkers and~     antioxidant capacity, as well as on cardiometabolic risk factors: anthropometric,~     inflammation and metabolic parameters in a healthy aging men and women.~   "
113719|NCT02078947|"~     Aim of the clinical multicenter study (OptimEx-CLIN) is to assess the optimal exercise~     intervention in patients with Heart Failure with preserved Ejection Fraction (HFpEF; also~     termed diastolic heart failure) that will best improve peak oxygen uptake (Peak Vo2) and~     additionally diastolic function (assessed echocardiographically). The investigators~     hypothesize that exercise training reverses HFpEF and that intensity of exercise training is~     more important than duration.~   "
113720|NCT02078934|"~     Incisional hernias occur in nearly 20% of all laparotomy incisions accounting for almost~     400,000 ventral hernia repairs annually in the United States. There is an even higher~     incidence of incisional hernia recurrence after prior repair if the patient is obese. Each~     subsequent hernia repair leads to increased morbidity and durability. It is not infrequent~     that many surgeons will advise overweight or obese patients to lose substantial weight prior~     to complex incisional hernia repair.~      However, it is quite difficult for any individual to lose more than 8 pounds a month in a~     safe, rapid, and sustainable fashion. This is based on losing 2 lbs. per week utilizing diet~     and exercise alone. Many patients with incisional hernia are physically debilitated that they~     cannot engage in any substantial physical activity to lose weight. Traditional laparoscopic~     bariatric surgery (i.e. Roux-en-Y gastric bypass (RYGB) and SG), while feasible, is a~     technically challenging endeavor since prior abdominal surgeries increase the amount of~     intra-abdominal adhesions. Furthermore, there is still a subset of patients who are not~     candidates for laparoscopic weight loss surgery because of inability to tolerate~     pneumoperitoneum due to underlying physiologic dysfunction.~      - Novel minimally invasive endoscopic technique may help obese patients with an incisional~     hernia lose weight in a safe and rapid fashion. Early case reports and small case series on~     gastric bypass revision utilizing such endoscopic technique have shown promise in efficacious~     weight loss. There have been reports of achieving nearly 20-25% excess weight loss.~      Abu Dayyeh and colleagues have also demonstrated that endoscopic gastric plication as a~     primary weight loss procedure is feasible, but their reported follow-up was only 3 months.8~     Brethauer, et al. from Cleveland Clinic performed transoral gastric volume reduction for~     weight management in 18 patients (TRIM TRIAL). They utilized the Restore Suturing System~     (Restore device) and reported a mean decrease in BMI of -4.0 ± 3.5 kg/m2. Mean excess weight~     loss was 27.7% ± 21.9% with no reports of adverse events.9 There have also been reports of~     not only weight loss but improved insulin sensitivity and secretion.10 Laparoscopic gastric~     greater curvature plication afforded a mean 50.7% excess weight loss at 12 months.11~      The intent of this study is not to demonstrate endoscopic suturing to be a primary option for~     weight-loss surgery. Preliminary reports have shown such procedure is technically feasible~     but not durable and the effects of the procedure varied widely among the study~     participants.12 The investigators view this technology as a bridge for morbidly obese~     patients, who will need subsequent surgery for another surgical disease, to improve their~     body habitus and decrease their postoperative morbidity and mortality. The aims of the~     investigators study are:~        -  Feasibility of endoscopic gastric sleeve plication~        -  Define the technical aspects of endoscopic suturing for sleeve plication~        -  Provide long-term follow-up for both weight loss and resolution of their co-morbidities~        -  Time from the endoscopic procedure to their incisional hernia repair~        -  Photographic evidence of the stomach after endoscopic plication during the incisional~          hernia repair~      There are several advantages for the proposed study. First it avoids entering the~     intra-abdominal cavity. Second, the procedure is performed solely with sutures obviating the~     need for stapling which may increase the risk of gastric leak from the staple line.13 Lastly,~     it avoids placing endoscopic intra-luminal devices such as intragastric balloons or~     duodenal-jejunal sleeves. Limiting factor of such devices is a high rate of premature device~     withdrawal due to intolerance. Furthermore, their effects are short-lived as most devices~     will need to be removed by 12 weeks and they only offer a mean 23.6% excess weight loss.13,~     14~      The implications of this study can be far-reaching. Once efficacy is demonstrated where~     enough weight loss is achieved that patients can safely and quickly undergo their incisional~     hernia surgery, the investigators can then conduct a retrospective case-control cross-matched~     study to further delineate its true benefit. If there is a true benefit, then a randomized~     control study can be employed in the future.~   "
113721|NCT02078921|"~     Previous studies have shown that interventions which modestly increase blood nitrite_ improve~     skeletal muscle function on exercise while sparing oxygen, and have been also shown to open~     up the blood flow during periods of oxygen deprivation. Inorganic nitrate in the diet is~     absorbed into the bloodstream, concentrated and reduced by bacteria in the mouth to nitrite,~     which is then absorbed into the bloodstream. .~      The purpose of this study is to look at the effects of oral inorganic nitrate supplementation~     on clinical markers of heart ischaemia and the frequency of angina.~   "
113722|NCT02078908|"~     The purpose of this study is to investigate the effect of different doses of sodium nitrite~     infusion in 12 healthy subjects. The effects on renal handling of nitrite, nitrate, sodium~     and water, plasma concentrations of vasoactive hormones, peripheral (brachial) and central~     blood pressure will be evaluated.~      Hypothesis~      Sodium nitrite infusion~        1. increases urinary sodium excretion and renal filtration rate~        2. lowers blood pressure, central as well as peripheral~        3. affects vasoactive hormones~        4. it is possible to establish a dose that affects the renal function with only minor~          effect on the blood pressure.~   "
113723|NCT02078895|"~     Botulinum toxin type A (Botox A) has shown great success in treating certain urologic~     conditions. A recent study has documented that Botox injected around the ureteral orifice (or~     place where the tube that connects the kidney to the bladder enters the bladder), during~     placement of a ureteral stent (small rubber tube that facilitate drainage of urine from the~     kidney to the bladder), resulted in a marked decline in the amount of stent pain experienced~     by patients. This finding was quite remarkable as stents are commonly used in many Urologic~     conditions, and these stents produce a remarkable degree of patient discomfort. Despite the~     great improvement in pain reduction, the irritative voiding symptoms [frequent need to void,~     urgency, burning with urination (dysuria) or nighttime voiding (nocturia)] were not~     ameliorated by the Botox injections in the ureteral orifice. However, it has already been~     well documented that in other clinical settings, administrations of Botox into the bladder~     muscle, has been shown to reduce these irritative symptoms.~      The objective of the study is to determine if pain and irritative lower urinary tract~     symptoms related to ureteral stent placement will improve after the injection of Botox around~     the ureteral orifice and in the bladder itself.~   "
113724|NCT02078882|"~     The purpose of this study is to determine if abatacept (Orencia) is effective in patients~     with primary biliary cirrhosis who do not respond adequately to standard treatment with~     ursodeoxycholic acid (UDCA, Urso, Ursodiol, Actigall).~   "
113725|NCT02078869|"~     When patients undergo in vitro fertilization (IVF), they often make more embryos than it is~     safe to transfer back in the womb all at once. These excess embryos are frozen and stored for~     future use. Frozen embryo transfer (FET) is therefore an important option of IVF where there~     are extra embryos. FET should take place under ideal conditions when uterine receptivity and~     uterine endometrial lining thickness are at the appropriate developmental stage as the~     embryo. A common way of preparing the uterus for FET is by using medications (Estrogen and~     Progesterone) that imitate a normal menstrual cycle while monitoring the endometrial lining~     development by transvaginal ultrasound. Progesterone (P4) may be administered vaginally or~     intra-muscularly (IM). The mode of Progesterone administration is based upon local~     conventions, experts' opinion and patients' preferences. All the mentioned modalities are~     common in the daily practice of IVF clinics across the world.~      The current medical literature does not present high quality evidence for the superiority of~     one form of Progesterone administration over the other for FET. The investigators know that~     in fresh embryo transfer cycles where natural follicles continue to function and produce~     Progesterone as corpora lutea, there were no reported differences in pregnancy rates when~     luteal vaginal P4 was compared with IM P4 support, but the investigators do not have the same~     reassurance regarding frozen embryo transfers. The aim of this study is to compare vaginal~     versus IM route of administration of P4 for FET cycle in a well-designed trial. Since many~     outcome variables are possible, the investigators have chosen to concentrate in the one that~     might shed light on a possible biological difference between the two modes of Progesterone~     administration; uterine contractions. Uterine contractions have been previously recognized as~     a possible factor that compromises success rates in patients undergoing IVF treatments.~     Progesterone is considered a uterine relaxant and its levels in the blood versus the levels~     in the uterus differ by its mode of administration: blood levels are higher when given IM~     whereas uterine P4 concentrations are higher when given vaginally. The investigators are~     interested to see whether IM progesterone in frozen embryo transfers presents a different~     uterine contraction pattern than the vaginal administration.~   "
113726|NCT02078856|"~     The purpose of this trial is to determine the efficacy and safety of A3384 administered to~     patients with Bile Acid Malabsorption (BAM)/Bile Acid Diarrhoea (BAD).~   "
113727|NCT02078843|"~     The investigators hypothesize that the new imaging method Gallium-68-DOTATATE has a higher~     diagnostic value in the detection of neuroendocrine tumors than the established imaging~     method Indium-111-Octreoscan. Therefore, the investigators will perform both imaging~     procedures in patients with suspected or confirmed neuroendocrine tumors. Subsequently, the~     investigators will compare the diagnostic performance of both methods.~   "
113728|NCT02078830|"~     The objective of this study is to assess the efficacy of 3M™ Tegaderm™ CHG I.V. Securement~     Dressing at the entry-site of a EVD in reducing quantity of microorganisms (CFU/cm2) after a~     time period of 5 days as a surrogate marker for EVD-associated infections [1, 2], compared to~     a nonantimicrobial polyurethane 3M Tegaderm™ Transparent Film Dressing. We aim to~     investigate, if the adjunct of an additional CHG-impregnated device on a routinely basis for~     the daily care is as a valuable and effective option to reduce contamination of the EVD~     entry-site and consecutive colonization of the catheter.~   "
113729|NCT02078817|"~     This study will test the use of ketamine for treatment of depression in adolescents that have~     not responded to other treatments. We will also examine neurobiological mechanisms of~     treatment.~   "
113739|NCT02078687|"~     This is a follow-up cohort study of 6 years old children born preterm in Denmark from~     2004-2008, and at four different neonatal units. During hospitalisation they received breast~     milk with fortification. At time of discharge there were made 3 different nutrition groups;~     if possible they were randomised into one of two groups:~        1. Breastfeeding solely~        2. Breastfeeding with fortification~           If breastfeeding was not possible they were put in group 3 and were bottle fed with:~        3. Preterm formula~      This nutrition intervention went on for 4 month. At the age of 6, the children will be~     invited to come for an ambulant control and other examinations regarding growth, allergy and~     metabolic syndrome.~   "
113730|NCT02078804|"~     Colorectal cancer (CRC) is a major cause of death in Sweden. There are approximately 6000 new~     cases each year in Sweden and the disease specific mortality is more than 40%. There risk is~     about 1% to develop CRC between 60-70 years of age making 60-year olds a suitable target~     population for colorectal cancer screening.~      The Swedish ministry of health and social affairs proposed a national study on the efficiency~     of colorectal cancer screening in the Swedish population regarding mortality, but also what~     screening method to be used. Eighteen participating counties of Sweden now fund the study to~     be launched in 2014.~      From the Register of the total population individuals 59-62 years of age will be randomized~     and invited by mail to screening. Twenty- thousand individuals will be invited to primary~     colonoscopy and 60 000 individuals will be invited to high sensitive FIT (approximately 10%~     positive) and if positive to a subsequent follow-up colonoscopy. If test negative a second~     round of FIT will be asked for in two years. In total 120 000 randomized individuals will not~     be invited to screening, but followed in the Swedish Cancer register and serve as controls.~     The inclusion period I set to three years (five years with the second round of FIT)~     generating approximately 5 000 colonoscopies yearly the first three years and 1200 year four~     and five at a compliance rate of 50% in the colonoscopy arm and 60% in the FIT arm.~      Follow-up time is set to 15 years with the primary endpoint disease specific mortality, but~     also incidence. Secondary outcomes by others to be studied are in short quality assurance~     variables of colonoscopy, participants and non-participants experiences of the invitation and~     the screening procedure, health economy measures of the CRC-screening study and when~     implemented in clinical care.~   "
113731|NCT02078791|"~     The patients who were not pain control, are referred to the Chronic Pain Unit so its~     complexity is greater. Made two different interventions in three groups of people with~     fibromyalgia. In the first group will proceed to infiltrate the painful area with medication,~     in the second GPST (Group Problem Solving Technique) and the third group both techniques.~     GPST will want to identify problems that people associate with fibromyalgia, as well as~     proposed solutions and it they have been carried out successfully or not. Will be essential~     to identifying and solving problems and using techniques to increase assertiveness,~     self-esteem and eliminating negative thoughts. Observing if after performing any of these~     techniques (infiltration, GPST or both) there is a better quality of life, reduce thoughts of~     suicide, pain and improves sleep quality. We also analyzed the satisfaction or not with~     therapies received and perceived usefulness.~   "
113732|NCT02078778|"~     The purpose of this study is to examine the effect on blood pressure of 3 months of treatment~     with continuous positive airway pressure (CPAP) in patients with obstructive sleep apnea~     (OSA).~      Hypothesis:~        1. Central 24-h blood pressure (BP) monitoring hedges day fluctuations in blood pressure~          more accurately than peripheral 24-h BP monitoring, because the measurement is painless~          and does not interfere with the patient / subject's activities during the daytime or~          nighttime sleep.~        2. Blood pressure is elevated in patients with OSA and falls during treatment with CPAP.~      3. The renal treatment of salt and water is abnormal in OSA, improved during treatment with~     CPAP.~      4. Quality of life improves during treatment with CPAP~   "
113733|NCT02078765|"~     A new study have shown that high night time blood pressure (BP) and/or non-dipping (lack of~     fall in BP during night time) is a strong predictor for the risk of cardiovascular disease~     and mortality in patients with hypertension. Three factors seem to affect the night time BP:~     chronic kidney disease, obstructive sleep apnea (OSA) and the way ambulatory blood pressure~     is monitored.~      Hypothesis:~      Central 24-h blood pressure monitoring is a better way of monitoring blood pressure than~     conventional peripheral monitoring.~      In hypertension, chronic kidney disease and obstructive sleep apnea (OSA) the night time~     blood pressure is elevated, and is OSA the elevation is correlated to the severity of OSA.~      In OSA the kidneys handling of salt and water is disturbed. In OSA there is disturbances in~     hormonal balance.~   "
113734|NCT02078752|"~     To assess the safety and tolerability at increasing dose levels of PF-06647263 in patients~     with advanced solid tumors in order to determine the maximum tolerated dose and select the~     recommended Phase 2 dose.~   "
113735|NCT02078739|"~     The combined diagnosis of chronic obstructive pulmonary disease (COPD) and heart failure (HF)~     is common but often missed because of similarities in clinical presentation, risk factors,~     and patient characteristics. The concurrent presence of both diseases worsens the limitations~     in exercise capacity and quality of life that patients experience with either disease alone.~     This pilot study will test the feasibility of a yoga program conducted in patients' homes~     using multi-point interactive videoconferencing (Tele- Yoga) for patients with combined~     COPD/HF diagnoses. The investigators hypothesize that patients who receive a yoga program at~     home, compared to an educational control group, will experience fewer physical symptoms and~     better quality of life.~   "
113736|NCT02078726|"~     The investigators believe that glucagon therapy will have a positive impact on key parameters~     of colonoscopy such as cecal intubation time, withdrawal time, total procedure time, adenoma~     detection rate, endoscopist's assessment of the difficulty of the procedure, patient comfort,~     and patient's willingness to undergo a repeat colonoscopy.~   "
113737|NCT02078713|"~     The investigators have designed a tablet-based decision support tool to help women learn more~     about their birth control options and support them in choosing a method they are happy with.~     The investigators will test whether the decision support tool helps women choose a birth~     control method they can continue using successfully by having some women use the tool before~     their birth control-related visit to a health care provider, and some women not use the tool~     before their visit. The investigators will then follow up with all the women at four months~     and seven months after their visit to see if they are still using the birth control method~     they chose at the visit and how happy they are with the method.~      Hypotheses:~        1. Women who use the contraceptive decision support tool will be more likely to continue~          using their chosen method at 4 and 7 months follow-up, compared to women who receive~          usual care.~        2. The contraceptive decision support tool will increase women's knowledge, choice of, and~          use of highly effective reversible contraception, compared to usual care.~        3. The contraceptive decision support tool will decrease decision conflict, compared to~          usual care.~        4. The contraceptive decision support tool will increase patient satisfaction with the~          clinic visit and with their method, compared to usual care.~        5. Women who use the contraceptive decision support tool will have fewer unintended~          pregnancies during the follow-up period, compared to women who received usual care.~        6. The contraceptive decision support tool will increase shared patient-provider decision~          making in contraceptive counseling visits, compared to usual care.~        7. The contraceptive decision support tool will decrease provider frustration when~          providing contraceptive counseling and increase provider job satisfaction.~        8. Women using the tool will be more likely to report use of any moderately or highly~          effective method of contraception at 4 and 7 months follow-up, compared to women not~          using the tool.~   "
113738|NCT02078700|"~     The objective of this phase 2 study is to evaluate the feasibility of an early palliative~     care intervention for metastatic cancer patients. Feasibility will be assessed in terms of~     percentage of patients that accept the proposal of the early palliative care intervention and~     that effectively start to be followed in the palliative care out-patient clinic. The study~     will be performed in a consecutive series of newly diagnosed patients affected by lung cancer~     (NSCLC or SCLC, stage IIIb, IV), mesothelioma (stage II, IV), pancreas (stage IV), stomach~     (stage IIIb-IV).~   "
113740|NCT02078674|"~     This is a randomized, observer-blinded, placebo-controlled trial in adults 18 to 64 years~     old. Randomization will be stratified by age (18 to 49 years and 50 to 64 years) and by prior~     influenza immunization within the past three months. Subjects 18 to 49 years of age will~     comprise ~67% of subjects in each treatment group, and the balance will comprise subjects 50~     to 64 years.~      Each subject will receive two identical IM doses of test article at a 21-day interval (Day 0~     and Day 21), in alternate deltoids. For each subject, study follow-up will span approximately~     385 days total, or approximately 13 months from the first dose.~   "
113741|NCT02078661|"~     To evaluate the safety and efficacy of 0.25% PG101 and 1.0% PG101 topical gel suspension~     compared to placebo when administered two times daily for 14 days in subjects diagnosed with~     dry eye syndrome~   "
113742|NCT02078648|"~     The purpose of this study is to determine the safety and efficacy of SL-701 as a treatment~     for recurrent glioblastoma multiform (GBM).~   "
113743|NCT02078635|"~     Presently in Canada, 29% of deaths are due to cardiovascular disease (CVD), costing $20.9~     billion annually. The investigators have, therefore, brought together an unique network of~     investigators at different stages in their careers with a range of disciplines (nutrition,~     cardiology, diabetes, imaging, physics, clinical trials, statistics, laboratory medicine,~     primary care, genetics, psychology, knowledge translation (KT), and epidemiology) and with~     international recognition , experience and connections, to undertake a multi-centre study~     which will test the ability of the dietary Portfolio PLUS approach over 3 years to reduce the~     progression of plaque build-up in the carotid artery as assessed by Magnetic Resonance~     Imaging (MRI) in individuals with hypercholesterolemia.~      The dietary portfolio of cholesterol-lowering foods (viscous fibres, soy protein, plant~     sterol and nuts) which has been proven in many of their studies to be an effective~     cholesterol-lowering diet will be further enhanced by increased levels of monounsaturated~     fats (MUFA) and low glycemic index foods. Will this enhanced dietary strategy (dietary~     Portfolio PLUS ) reduce the progression of carotid atheromatous lesions, LDL-C and blood~     pressure while reducing the number of hyperlipidemic individuals requiring statins?~   "
113744|NCT02078622|"~     Evaluate subjects in an prospective randomized controlled trial in which subjects will be~     administered scientifically validated questionnaires to determine the effect of the education~     and case management by Respiratory Therapists (RTs) on improvements in: health outcomes and~     quality of life as primary endpoints~      Utilize: Chronic Respiratory Disease Questionnaire (CRQ)~      The secondary endpoints will be: Rate of exacerbation's, Health care utilization (emergency~     room encounters, hospital admissions)~   "
113745|NCT02078609|"~     This study will assess the safety and preliminary efficacy of escalating doses of LGH447~     monotherapy in AML and MDS and LGH447 in combination with midostaurin in AML.~   "
113746|NCT02078596|"~     Though the Disruptive Disorders of Childhood and Adolescence are a major source of morbidity~     and fill a large proportion of special education slots, specific pharmacologic treatment is~     available only for those children with Attention Deficit/Hyperactivity Disorder. Other~     disruptive children are usually said to have Oppositional Defiant or Conduct Disorder.~     These diagnoses are useful descriptively but they do not have specific treatment implications~     In the course of treating adolescents with explosive tempers and severe mood swings with~     Depakote (divalproex sodium), the investigators learned that younger children manifest~     symptoms that seemed identical to those constituting the adolescent disorder. They were in~     special education programs and not responding to psychostimulants.~      The investigators systematically collected data on these children using the same screening~     criteria as in our studies of adolescents. Since Depakote has been used to treat seizures in~     children for more than twenty years, a great deal was known about its safety profile in the~     pediatric population. The investigators treated 7 children, age 7-12, whose recurrent temper~     outbursts and chronic mood lability did not respond to individual/family therapy. After~     parents signed informed consent and children gave assent, these subjects would receive open~     label Depakote in doses sufficient to reach a blood level between 50-100 micrograms/ml for~     six weeks. The family received supportive therapy.~   "
113747|NCT02078583|"~     Benzodiazepines is a commonly uesd sedative medication,there are many reports that~     Benzodiazepines is associated with delirium ,but using of analgesia reduces benzodiazepines~     requirements .The purpose of this study is to determine whether analgesia based sedation~     protocol reduces the incident of delirium.~   "
113748|NCT02078570|"~     The major purpose of this study is to evaluate a laboratory developed test that measures~     multiple breast cancer-specific biomarker proteins and multiple antibodies in your blood~     samples. The biomarker and antibody results along with your personal medical profile will be~     evaluated to determine your risk for the presence of a malignancy in the breast as compared~     to your breast evaluation assessment conducted by your physician.~   "
113749|NCT02078557|"~     This study will assess multiple doses of MK-8892 administered to participants with pulmonary~     hypertension out of proportion (PHOOP) and heart failure with reduced left ventricular~     ejection fraction (rEF). It is hypothesized that generally safe and well tolerated multiple~     doses of MK-8892 will achieve a true reduction from baseline in pulmonary vascular resistance~     (PVR) greater than 12%.~   "
113750|NCT02078544|"~     The purpose of the study is to identify biomarkers and potentially actionable mutations/~     activated molecular pathways and evaluate the impact of molecular profiling information on~     patients with gynaecological cancer.~      The hypothesis of the study are:~        -  Analysis of gynaecological tumour samples will allow us to identify novel and/or~          actionable molecular changes that may drive therapeutic strategies for the management of~          these cancers.~        -  Molecular profiling will improve the outcome of novel targeted-agent treatment in~          clinical trials~        -  Molecular profiling of paired samples (primary/recurrent and primary/metastatic) will~          provide new insights into mechanisms underlying drug resistance and metastasis in~          gynaecological cancers.~   "
113761|NCT02078401|"~     The goal of this project is to get more insight into the (neuro)ophthalmological~     characteristics of children with neurofibromatosis type 1. This way investigators would like~     to update the current guidelines for follow up and treatment of optic pathway gliomas.~     Clinical findings will be compared with the results of Optical coherence tomography (OCT) and~     MRI (magnetic resonance imaging).~   "
113751|NCT02078531|"~     The purpose of the study is to examine cognitive and brain function in stage I-III breast~     cancer patients who have undergone adjuvant systemic therapy (chemotherapy or chemotherapy~     plus anti-hormonal therapy) in comparison to a group of healthy controls.~      Our hypothesis is that systemic adjuvant therapy in the form of chemotherapy or chemotherapy~     and anti-hormonal therapy given to primary breast cancer patients can cause cognitive~     impairment. We hypothesize that the use of simultaneous PET/MRI will allow us to determine~     key regions in the brain that show metabolic, structural, and functional deficits in a~     semi-quantitative manner and reveal subtle changes that are often missed during~     neuropsychological tests due to the low sensitivity of neuropsychological batteries.~   "
113752|NCT02078518|"~     The purpose of this study is to gives understanding to level of physical activity, occurrence~     of fatigue and quality of life amongst multiple myeloma survivors in the local setting. As~     multiple myeloma survival improves, it is vital to focus on interventions that will help to~     maximize QOL. A positive correlation may suggest that exercise is such an intervention.~      The hypothesis are multiple myeloma survivors are performing low levels of physical activity.~     Higher levels of physical activity will be associated with higher levels of QOL and lower~     fatigue levels.~   "
113753|NCT02078505|"~     The polycystic ovary syndrome is intimately associated with body weight and nutrition.The~     genomic era did not bring a breakthrough to the understanding of the syndrome. The recent~     surge of studies on gut microbiome has raised the possibility that the specific diet, which~     often affect these women favorably, would change their gut microbiome. Hence, the~     investigators will examine their gut microbial population in comparison to normal ovulatory~     women and then examine whether a low carbohydrate diet causes favorable change in their gut~     microbial population.~   "
113754|NCT02078492|"~     Hypothesis: Intravenous administration of Ketorolac in a dose of 10 mg is as effective in~     treating severe acute pain in patients presenting to the ED as 15 mg and 30 mg.~   "
113755|NCT02078479|"~     The purpose of this study isto assess the efficacy of daily 10 sessions of rTMS over primary~     motor cortex in patients suffering from malignant neuropathic pain. Thirty four patients were~     divided randomly into 2 groups equally using closed envelops to undergo real (20 Hz, 10~     second, 10 trains with inter-train interval 30 second with total pulses 2000, intensity 80%~     of motor threshold over hand area of motor cortex) or sham rTMS (same parameters but with~     coil elevated and angled away from the head)every day for ten consecutive days (5 days/week).~     Patients were evaluated using a verbal descriptor scale (VDS), visual analog scale (VAS),~     Leeds assessment of neuropathic symptoms and signs (LANSS) and Hamilton rating scale for~     depression (HAM-D) at baseline, after 1st, 5th, 10thtreatment session, and then 15 days and 1~     month after the end of treatment. ic pain.~   "
113756|NCT02078466|"~     The aim of this study is to examine the effect of an intervention that consist of assessment~     of functional ability, rehabilitation plan and follow-up at home for older medical patients.~      The hypothesis is that assessment of functional ability, development of rehabilitation plan~     and follow-up at home reduce the older medical patient's risk of readmission. Also the~     intervention is expected to reduce mortality, number of contacts to general practitioners and~     emergency physician~   "
113757|NCT02078453|"~     Radiographs have been used to aid dentists in detecting the presence of cavities in the~     deciduous teeth of children. This procedure is globally recommended because the conventional~     clinical examination usually overlooks some cavities. However, the real benefit of performing~     dental radiographs for this purpose is still unclear. Besides the hazards of ionizing~     radiation, the radiographs could provoke overtreatment of the children; hence, dentists would~     tend to restore more teeth than would be really necessary. Nowadays, it is preferable to~     overlook some cavities than treat the teeth unnecessarily. Therefore, the investigators aimed~     to perform this study to compare two different strategies for detecting cavities in deciduous~     teeth of children: one based on clinical examination performed alone and other using~     radiographs adjunct to the clinical examination. To compare these strategies, the~     investigators will consider outcomes related to children's health and welfare.~   "
113758|NCT02078440|"~     The objective of this study is to evaluate the relative bioavailability, and the rate and~     extent of absorption of bromocriptine in male and female children and adolescent Type 2~     Diabetes Mellitus patients, aged 10 to less than 18, under fed conditions.~      It is undetermined if the pharmacokinetic profile of bromocriptine-QR in type 2 diabetes~     children aged 10- to less than 18 years differs appreciably from that in healthy adults.~     Bromocriptine is extensively metabolized by the liver (namely CYP3A4). Studies in children~     have demonstrated little difference in clearance among children over 10 years of age compared~     to adults (Blanco et al, 2000). However, differences in blood volumes or other factors may~     impart differences that could affect the pharmacokinetic properties of bromocriptine-QR.~     Therefore, this study will assess the pharmacokinetics in children aged 10-to less than 18~     years who have type 2 diabetes. After describing the profile of bromocriptine-quick release~     in this patient population, a follow on study will be conducted to evaluate its safety and~     efficacy in treating children and adolescents who have type 2 diabetes.~      The pharmacokinetic profile of bromocriptine will be determined following the administration~     of a single, weight-adjusted dose of CYCLOSET (bromocriptine mesylate) tablets. The study~     will be a single period, bioavailability study in 30 patients. The study duration will be 3~     days.~   "
113759|NCT02078427|"~     The purpose of the study is to document the natural history of hemophilia. A disease and~     long-term outcomes in terms of effectiveness, safety and quality of life (QoL) in~     participants receiving ADVATE in routine clinical practice. Participants may use any~     treatment regimen, including on-demand and prophylaxis using standardized regimens or~     individual pharmacokinetic (PK)-guided dosing regimens, or immune tolerance induction (ITI)~     therapy, as determined by the treating physician.~   "
113760|NCT02078414|"~     Women using an emergency contraceptive method must use back up protection for 1-2 weeks~     depending on method. The Copper-IUD is the most effective emergency contraceptive method. The~     investigators wish to explore if women choosing the Cooper IUD have a higher frequency of use~     of an effective contraceptive method 3 months and 6 months after the use of an emergency~     contraceptive method than women who choose to use the emergency contraceptive pill EllaOne~     (ulipristal acetate).~   "
117770|NCT02025998|"~     The objective of this proposal is to advance medication development for alcoholism by~     conducting a safety and initial efficacy study of ibudilast, a neuroimmune modulator and~     phosphodiesterase inhibitor, for alcohol use disorders.~   "
113762|NCT02078388|"~     The purpose of this study is to identify the genetic variants that are associated with higher~     risk of doxorubicin-induced cardiotoxicity can contribute towards developing a predictive~     algorithm comprising both clinical and genetic factors to select patients who should avoid~     treatment with anthracyclines.~      Hypothesis of this study is certain functional variants in genes that encode for metabolizing~     enzymes and/or targets in the doxorubicin pharmacology pathway may increase the risk of~     doxorubicin-induced cardiomyopathy~   "
113763|NCT02078375|"~     This study will evaluate if the combination of resistance exercise and protein~     supplementation will increase muscle strength and muscle mass among older individuals with~     rheumatoid arthritis (RA).~   "
113764|NCT02078362|"~     Peripheral blood will be taken from the enrolled patients at National University Hospital and~     from healthy volunteers. ADCC assay will be performed for evaluating efficacy of new medicine~     candidates.~   "
113765|NCT02078349|"~     This is an open-label, dose-escalation (Phase 1a) and expansion (Phase 1b) study to evaluate~     the safety and tolerability of KPT-330 and determine the recommended phase 2 dose (RP2D) in~     patients with solid tumor malignancies. The study drug KPT-330 or Selinexor works by blocking~     high levels of exporter proteins in cancer cells so that the tumor suppressor proteins (TSP,~     proteins that help to protect cells from becoming cancerous) and growth regulatory proteins~     (GRP, proteins that help control the growth of cells) will remain in the nucleus in its~     activated form. The idea for using this drug is that the blockage of this export of~     proteins from the nucleus should result in stopping the growth of tumor cells. Based on its~     mechanism of action, KPT-330 is a new class of drug called Selective Inhibitor of Nuclear~     Export (SINE).~      The purposes of this research study are to find out more information about the drug such as:~     the highest dose of KPT-330 that can be given safely, the side effects it may cause, to~     examine how the body affects the study drug concentrations in the blood (called~     pharmacokinetics or PK), to examine the effects of this study drug on the body (called~     pharmacodynamics or PD) and to gain some information on its usefulness in treating cancer.~      Benefits of the study include the chance of disease control for patients with treatment~     refractory cancer for which no other standard treatments are available. Common side effects~     (35-73%) in humans have mostly been mild and reversible. These include nausea, loss of~     appetite, fatigue, vomiting and weight loss.~   "
113766|NCT02078336|"~     The study aims to compare procedural sedation protocols, specifically applied for the~     delivery of regular dental care in persons with a mental disability.~      The primary objectives are:~        -  To assess the level of cooperation during regular dental care using different procedural~          sedation protocols~        -  To assess patient safety during regular dental care using different sedation protocols~        -  To assess patient comfort and possible side-effects after regular dental care using~          different sedation protocols~   "
113767|NCT02078323|"~     The purpose of this study is to understand how a drug called Linaclotide improves bowel~     function and abdominal pain in patients with Irritable Bowel Syndrome with Constipation~     (IBS-C) as well as to examine whether Linaclotide alters communication between the brain and~     pelvic-floor region.~      Linaclotide has been shown to improve abdominal pain and bowel symptoms in IBS-C, and is~     approved by the FDA for the treatment of this condition. However, how exactly this drug works~     to relieve abdominal pain and discomfort in humans is not clearly known. Studies in animal~     models suggest that patients with IBS-C have hypersensitivity in the gut.~      Consequently, in IBS-C patients, there is rapid and excessive conduction of signals both from~     the brain and central nervous system region towards the pelvic-floor (anorectal axis) and the~     reverse direction. The investigators hypothesize that treatment with Linaclotide may~     improve/normalize these signals and thereby improve bowel symptoms.~      Investigators will test this theory using a new, noninvasive (and established) method of~     studying this communication pathway between the brain and gut.~   "
113768|NCT02078310|"~     A Phase 1b/2, Randomized, Double-blind, Placebo-Controlled, Multiple Oral Dose Escalation~     Study to Assess Safety, Tolerability and Pharmacokinetics of ITI-007 in Healthy Geriatric~     Volunteers and in Geriatric Patients with Dementia~   "
113769|NCT02078297|"~     The goal of this project is to study some mechanisms involved in the dysregulation of the~     immune system observed in the skin of subjects with psoriasis. This will be done by analyzing~     specific immune cells as well as gene and protein expression in small skin samples (biopsies)~     from patients with psoriasis. These results will be compared to the skin of healthy subjects~     without psoriasis.~   "
113770|NCT02078284|"~     This study is to evaluate the safety of intravenous (IV) infusion of dimethyl sulfoxide~     (DMSO) cryopreserved platelets (CPP) in participants with World Health Organization (WHO)~     Grade 2 bleed in spite of receiving a transfusion of liquid stored platelets (LSP) in the~     past 48 hours by collecting adverse events (AEs) and by evaluating coagulation-related~     parameters to assess the evidence of any thrombotic events after CPP or LSP transfusion.~   "
113771|NCT02078271|"~     WHO has urged all developing countries to develop programmes to improve complementary-feeding~     (CF) practices because of their importance for optimal growth, development and health of~     infants and young children While supplementation programmes and/or highly-fortified~     super-foods have limited success in improving CF-practices in disadvantaged environments,~     population-specific food-based dietary guidelines (FBDG), based on locally-available foods~     and requires minimal changes to local food pattern, will enhance the chances of programme~     success.~      Our previous study was able to identify the need for, potential and finally develop FBDG for~     CF of 6-8mo and 9-11mo infants using combined linear-and-goal programming approach (LP~     approach). This research is therefore being made to support the next phase of the study i.e.~     to assess the efficacy of FBDG, for improving CF/dietary-practices and growth in <24mo~     children (window of opportunity). As growth and development is inter-related, home-based~     stimulation will be included in this trial to see the effect on child development. While~     studies have shown that stimulation at early age benefits children through their late~     adolescence; evidence from Indonesia is lacking. This study therefore aims to see the effect~     on growth and development of community trial using food-based dietary guideline and~     stimulation. It is expected that findings from this study will provide scientific evidence as~     the basis for program formulation.~   "
113772|NCT02078258|"~     In this study, we test whether a two-week 8-session attention bias modification (ABM)~     training could reduce depressive symptoms relative to placebo controls in adolescents with~     major depressive disorder at posttraining and follow-ups.~   "
113773|NCT02078245|"~     Early detection of pre-cancerous lesions or early stage pancreatic cancer seems to have a~     positive impact in survival for patients with an increased genetic risk to develop pancreas~     cancer.~      In this study, following the indication of the swedish guidelines, consecutive patients with~     a family history for pancreas cancer underwent a clinical surveillance Magnetic Resonance~     Imaging (MRI) based. The results of this study were analyzed looking in the patients files~     collected during the screening period.~   "
113774|NCT02078232|"~     The purpose of this study is to compare the diagnostic gain between 22G standard needle vs~     19G Flex needles transduodenal punctures of masses of the pancreatic head.~   "
113775|NCT02078219|"~     This study is to examine the hypothesis that administration of RDEA3170 to Japanese patients~     with gout or asymptomatic hyperuricemia in doses of 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg~     once daily, respectively will result in greater reduction of sUA compared to placebo.~   "
113776|NCT02078206|"~     The purpose of this project is to assess the efficacy of an early neurocognitive intervention~     for ICU patients, in terms of psychopathological, neuropsychological and functional~     improvement. The treatment is supported in an interactive advanced computing platform that~     includes the continuous biomedical registration of the patients and a virtual reality~     software specifically designed for critical patients.~      The investigators expect an improvement in neuropsychological, psychopathological and~     functional status at hospital discharge and 3 months follow-up in those patients that have~     received the early neurocognitive intervention comparing with patients treated as usual.~     Furthermore the investigators expect a decrease of episodes and/or duration of delirium in~     ICU patients.~   "
113777|NCT02078193|"~     The primary objective of this study is to demonstrate that administration of belatacept in~     maintenance kidney transplant recipients may cause a reduction in Donor Specific HLA Antibody~     (DSA).~   "
113778|NCT02078180|"~     The objectives of this project are to determine if the bioavailability and release pattern of~     bupropion HCl products differ and if the genotype of the metabolic enzymes affects the~     saturation of intestinal enzymes with different dose strengths within one product line.~     Findings from this project will help the FDA Center for Drug Evaluation and Research's (CDER)~     Office of Generic Drugs improve policy development and review practice in the future for~     similar products, e.g. extended release oral drug products being metabolized in the gut wall~     and having multiple strengths.~      Aim 1: To compare the pharmacokinetics of bupropion and its metabolites in plasma in healthy~     individuals when they ingest different strengths of bupropion (75-300 mg) with variable~     release profiles (IR vs XL vs SR) in GI tract.~      Working hypothesis: Variation in release rate and mechanism of bupropion formulations in~     gastrointestinal (GI) tract will impact metabolism and saturation of bupropion in GI tract,~     which will generate different concentration of bupropion and its metabolites in plasma.~      Aim 2: To investigate pharmacogenomics of CYP 2B6 that influences metabolism, saturation, and~     pharmacokinetics of bupropion~      Working hypothesis: The gain of function of CYP2B6 variants (allele *4 and *22) in patients~     will increase the metabolism of bupropion in the GI tract and liver, reduce both local~     concentration and plasma concentration of bupropion, and thus cause non-bioequivalence when~     bupropion is released earlier in GI tract~   "
113779|NCT02078167|"~     Background: Statins are at the forefront of strategies to manage hypercholesterolemia.~     However, 10-15% of patients result to be intolerant to any statins, even at low daily doses~     and almost one- third of statin users discontinue therapy within one year. Some~     nutraceuticals are prescribed as lipid- lowering substances, but doubts remain about their~     efficacy and tolerability. In this study we investigated the effects of a nutraceutical~     combination consisting mainly of red yeast rice extract 200 mg (equivalent to 3 mg~     monacolins), berberine 500 mg and policosanols 10 mg (MBP-NC).~      Methods: In this single centre, randomized, double-blind, placebo-controlled study 60~     consecutive outpatients (age range: 18-60 years), with newly diagnosed primary~     hypercholesterolemia not previously treated, after a run-in period of 3 weeks on a stable~     hypolipidic diet, were randomized to receive a pill of MBP-NC (N=30) or placebo (N=30) once a~     day after dinner, in addition to the hypolipidic diet. The efficacy and the tolerability of~     the proposed nutraceutical treatment were fully assessed after 4, 12 and 24 weeks of~     treatment.~   "
113780|NCT02078154|"~     Measurement of D-Di (D-Dimer) levels using the in-vitro diagnostic reagent STA® - Liatest®~     D-Di and STA® - Liatest® D-Di PLUS in plasma samples from patients diagnosed with Deep Vein~     Thrombosis (DVT) Data from this study may be used in conjunction with data from the~     prospective study entitled STA® - Liatest® D-Di - Exclusion of Venous Thromboembolism~     (VTE), NCT01221805, the DiET study,~   "
113781|NCT02078141|"~     18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) may have application in a~     promising tool for identification of myocardial inflammation in patients with dilated~     cardiomyopathy (DCM).Therefore, the purpose of the study is to confirm the hypothesis of the~     fixation of FDG in non cardiomyocyte cells in a number of patients with DCM, to specify the~     frequency and describe the different binding profiles in comparison with MRI data.~      Patients will perform an ethologic evaluation of a non ischemic DCM with in a cardiac MRI.~      All patients will have with in 4 weeks after the MRI a 18F-fluorodeoxyglucose (FDG) PET. A~     high fat and low carbohydrate diet and an heparin injection will be prescribed to patients~     before this FDG PET.~      Patients will be identified as FDG+ or FDG -. The clinical status of the patient will be~     completed by a 12 months evaluation.~   "
113782|NCT02078128|"~     The purpose of this study is to determine the effect of β-glucans on wound healing.~   "
113783|NCT02078115|"~     The purpose of this study is to find the change of blood pressure (BP) control pattern (true~     controlled, white-coat, masked, and sustained uncontrolled/ dipper, non-dipper,~     reverse-dipper, and extreme-dipper) in patients with chronic kidney disease (CKD) over 3~     years. And Other objective is the relationship between the BP control pattern and the target~     organ damages such as renal function, proteinuria, left ventricular hypertrophy (LVH), and so~     on. In addition, we will find clinical factors related to the BP control pattern.~   "
113784|NCT02078102|"~     The trial is an open label Simon optimal two-stage Phase II trial of fixed doses of oral~     meloxicam and subcutaneous filgrastim to assess the safety and efficacy in mobilizing~     autologous peripheral blood stem cells (PBSC) from multiple myeloma (MM) and non-Hodgkin's~     lymphoma (NHL) patients planning to undergo high-dose chemotherapy with stem cell support.~     Clinical data regarding the cellular composition and function of the graft mobilized by this~     combination will be obtained.~   "
113787|NCT02078063|"~     Use of long acting reversible contraception (LARC) such as implants or intrauterine~     contraception (IUC) has been shown to reduce repeat abortions. LARCs have the advantage of~     being independent of user error and are considered to be underused, especially among young~     individuals where oral methods have high rates of user failure. IUC is often underused in~     young or nulliparous women due to fear of pain at insertion.~      10 ml of mepivacaine (10mg/ml) or 10ml of sodium hydrochloride will be injected into the~     uterine cavity through a hydrosonography catheter before the tenaculum has been applied but~     prior to sounding and to insertion of the IUC.~      The investigators' hypothesis is that instillation of 10 ml (10mg/ml) mepivacaine though a~     hydrosonography catheter prior to any instrument placement will provide more effective pain~     relief than instillation of 10 ml placebo (sodium chloride 9mg/ml).~      Primary objective: To evaluate the difference in pain score at the time of the insertion of~     the IUC between treatment and control group.~      Secondary objectives: To evaluate acceptability of the procedure.~   "
113788|NCT02078050|"~     Respiratory failure is the main death cause in neuromuscular diseases. Non-invasive and~     volitional measures of inspiratory muscles strength include the nasal pressure with an~     occluded nostril (Psnip) and the maximal inspiratory pressure (PImax). Unfortunately,~     volitional maneuvers depend of patient effort. The aim of this research is to validate a~     non-invasive and non-volitional technique to evaluate diaphragm strength at neuromuscular~     diseases patients. The methodology consists to add to PImax and Psnip measures 5 phrenic~     nerves magnetical stimulation maneuvers (Pstim).Stimulations will be realize at 3 inspiratory~     pression levels (0, -1 cm H2O and -5 cm H2O).~   "
113789|NCT02078037|"~     Patients with a supratentorial intracerebral hemorrhage will be randomly assigned to either~     the experimental group which will keep them at a normal body temperature or the standard of~     care group. The investigators propose to test the hypothesis that prophylactic forced~     normothermia in patients with ICH leads to less systemic inflammation and decreased~     perihematomal edema.~   "
113790|NCT02078024|"~     We will examine whether a combination of Ivermectim (IVM) plus Albendazole (ALB) compared to~     IVM alone given annually, which is the current standard for mass drug administration (MDA),~     is more effective in sterilizing adult worms. We will also address whether IVM plus ALB given~     twice per year is superior to IVM given once per year or twice per year.~   "
113791|NCT02078011|"~     The purpose of this study is to test an investigational device called the Echopulse for~     treatment of breast fibroadenomas in women. Fibroadenomas are benign (noncancerous) breast~     tumors that are made of glandular and fibrous breast tissue. These lumps can occur alone, in~     groups, or as a complex of lumps together. Sometimes women feel these in the breast when~     doing regular self breast exams, or they may be found during a routine mammogram. Some are~     small (less than an inch in size), and others are quite large (the size of a lemon or~     larger).~      This is a study about the Echopulse device, a computer driven system which uses ultrasound to~     guide a high intensity focused ultrasound beam to a targeted area (the fibroadenoma in the~     breast). The high intensity focused ultrasound (HIFU) heats the targeted site which causes~     the cells to die and allows the possibility to treat the fibroadenoma without the need for~     surgery.~   "
113792|NCT02077998|"~     This phase 0/II trial studies the effect of carbon C 14 oxaliplatin in tumor tissue and blood~     and the side effects and how well oxaliplatin works in treating patients with metastatic~     breast cancer. DNA analysis of tumor tissue and blood samples from patients receiving carbon~     C 14 oxaliplatin may help doctors predict how well patients will respond to treatment with~     oxaliplatin. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~   "
113793|NCT02077985|"~     The goal of this project is to collect information that will support a later clinical trial~     on the effectiveness of a specially adapted dental environment for children who have~     difficulty tolerating oral care in the dental clinic. We hypothesize that adapting the~     sensory environment in the dental office by modifying the sounds, sights, smells and tactile~     experiences will result in decreased anxiety, increased cooperation, and fewer behavior~     problems for children with Autism Spectrum Disorders, and to a lesser extent for typically~     developing children especially those who have dental anxieties. This has the potential~     contribute to increased child comfort as well as safer, more efficient, and less costly~     treatment for a large population, as potentially more than one-fourth of all children may~     benefit from a sensory adapted dental environment.~   "
113794|NCT02077972|"~     Combat-related post traumatic stress disorder (PTSD) has become an increasingly pressing~     public health problem in the United States following the overseas wars of the last decade.~     Rates of PTSD have skyrocketed in the military and among veterans, leading to increased rates~     of suicide, impairment on the job and off, and behavioral changes that negatively affect not~     just the veteran, but also his or her family. Although effective medication and psychotherapy~     treatments exist for combat-related PTSD, many individuals suffering with PTSD do not~     adequately respond to currently available treatment options, highlighting the need to develop~     and test new interventions for the disorder. To address this pressing clinical issue, the~     investigators will conduct a pilot study to determine if Whole Body Hyperthermia (WBH)~     reduces symptoms in adults suffering from combat-related PTSD. The investigators plan to~     recruit a sample of 10 medically healthy individuals with combat-related PTSD who will~     receive a single session of WBH to determine if this single session improves PTSD symptoms~     and, if so, whether this improvement will last at least 2 weeks. To do this, the study will~     include basic clinical and psychiatric assessments immediately before and one and four weeks~     after WBH. Because sleep is so often impaired in PTSD, the investigators will measure at-home~     sleep patterns for a week prior to and a week following the WBH session using sleep diaries~     and a wristwatch actigraphy device. Given scientific evidence from our research group that~     WBH may improve depression, the investigators anticipate that it may also be of benefit or~     adults suffering from combat-related PTSD.~   "
113795|NCT02077959|"~     This phase I/II trial studies the side effects and best dose of lenalidomide and pidilizumab~     and to see how well they work in treating patients with multiple myeloma that has come back~     (relapsed) or has not responded to treatment (refractory). Biological therapies, such as~     lenalidomide, may stimulate the immune system in different ways and stop cancer cells from~     growing. Monoclonal antibodies, such as pidilizumab, can block cancer growth by blocking the~     ability of cancer to grow and spread. Giving lenalidomide with pidilizumab may work better in~     treating relapsed or refractory multiple myeloma.~   "
113798|NCT02077920|"~     Ventilator-associated pneumonia (VAP) is common in patients receiving mechanical ventilation,~     and is associated with longer hospital stay, increased treatment costs, and higher rates of~     morbidity and mortality . VAP is reported to occur in 8%-67% of mechanically ventilated~     patients (20%-28% in most reports) and has a mortality rate of 24%-50%, which is 2-3 times~     the mortality rate of mechanically ventilated patients without VAP. In patients infected by~     multi-resistant bacteria, the mortality rate may be as high as 76%. The diagnosis, treatment,~     and prevention of VAP are therefore important. Strategies for preventing VAP are crucial for~     reducing medical costs and increasing survival rates in critically ill patients. These~     strategies mainly involve a semi-reclining position with the head of the bed raised to at~     least 30°-45°, oral care, suctioning of subglottic secretions, selective decontamination of~     the digestive tract, proper hand washing, avoidance or reduction of proton pump inhibitors,~     avoidance of excessive sedation, and control of plasma glucose levels.~      At our center, VAP is mainly caused by bacterial colonization of the upper respiratory tract~     via aspiration. This study will compare four interventions including oropharyngeal~     decontamination and subglottic suctioning by bronchoscopy, with the aim of developing a~     prevention strategy to minimize the development of VAP during mechanical ventilation.~   "
113799|NCT02077907|"~     The objective of this study is to test and compare the effectiveness and cost-effectiveness~     of four supplementary foods for the treatment of moderate acute malnutrition (MAM) in normal~     programmatic settings in Sierra Leone. Study participants will receive one of four test foods~     varying in energy and nutrient density as well as amounts provided.~        1. Super Cereal Plus (SC+) at 800 kcal/d, 215 g/d (Control group)~        2. Super Cereal (SC) and oil and sugar at 998 kcal/d - 200 g SC and 20 g oil and 20 g~          sugar, per day~        3. Corn-soy Blend 14 (CSB14) and oil at 978 kcal/day - 150 g CSB14 and 45 g oil, per day~        4. Plumpy'Sup - 500 kcal/d, 92 g/d~      This will be a prospective, randomised, controlled effectiveness trial.~      Aims~        1. (Impact) To compare the effectiveness of four supplementary foods in the treatment of~          moderate acute malnutrition (MAM) in normal programmatic settings in Sierra Leone.~        2. (Cost) To estimate the relative cost-effectiveness (marginal cost per child recovered~          from MAM, relative to comparison group, SC+) of implementing the feeding program using~          each commodity, taking into consideration costs of procurement/production and~          distribution~        3. (Process) To evaluate the determinants of effectiveness including: consumption~          adherence, preparation compliance, targeting/sharing of supplement, food components and~          preparation, adverse effects of foods, water contamination, hygiene and health~          behaviors, SES, food security, perceived barriers~      Outcomes~        1. Recovery from MAM~             1. Percent of children recovered from MAM (defined as achieving mid-upper arm~               circumference (MUAC) ≥ 12.5 cm by 12 weeks once)~             2. Percent default/non-response: children who do not recover after 12 weeks~             3. Percent relapse: children who become MAM again within 6 months of recovery~        2. Mean number of weeks to recovery~      Hypothesis The children with MAM fed Super Cereal and oil and sugar, CSB14 and oil or~     Plumpy'Sup will have similar recovery outcomes to those children fed Super Cereal Plus.~      Null: The children with MAM fed Super Cereal and oil and sugar, CSB14 and oil or Plumpy'Sup~     will have different recovery outcomes to those children fed Super Cereal Plus.~   "
113800|NCT02077894|"~     Objective: The objective of this study is to identify genetic causes of inherited eye~     conditions through whole exome or whole genome sequencing. This includes identifying~     mutations in known genes or novel genes for recognized conditions, as well as identifying~     mutations in novel genes for previously uncharacterized genetic conditions involving the eye.~      Study Population: We plan to recruit 310 participants, to include both probands with an eye~     condition under study and unaffected family members. Ideally unaffected family members will~     be parents of a proband.~      Design: Participants will be recruited through other pre-existing NIH protocols, such as the~     NEI Evaluation and Treatment protocol (08-EI-0169), the NEI Screening protocol (08-EI-0102),~     and the Genetics of Uveal Coloboma protocol (13-EI-0049). Self-referred patients or patients~     referred by an outside clinician will be screened for eligibility under a pre-existing NIH~     protocol. Phenotyped patients eligible for participation and their unaffected family members~     will undergo genetic counseling and will provide a blood sample for exome or genome~     sequencing. Biological relationships will be confirmed prior to exome or genome sequencing.~     Sequence data will be analyzed for primary variants associated with the proband s eye~     condition and incidental findings, as recommended by the American College of Medical Genetics~     guidelines. All sequence variants deemed clinically relevant will be validated in a~     CLIA-certified laboratory and the results will be returned to the participant in-person.~      Outcome Measures: This is an etiologic study that will generate molecular information about~     previously-recognized conditions for which participants did not have a molecular diagnosis,~     as well as molecular information for previously uncharacterized conditions involving the eye.~   "
113801|NCT02077881|"~     This phase I/II trial is designed to efficiently identify the regimen limiting toxicity (RLT)~     and recommended phase 2 dose (RP2D) for the combination of the immunotherapeutic agent~     indoximod when administered in combination with standard of care chemotherapy gemcitabine~     plus nab-paclitaxel in subjects with metastatic adenocarcinoma of the pancreas. All subjects~     will receive the same standard gemcitabine plus nab-paclitaxel regimen, plus indoximod in~     doses increasing from 600 mg twice daily to, potentially, 1200 mg twice daily.~   "
113802|NCT02077868|"~     The purpose of this this trial is to prove the efficacy and safety of MGN1703 as a~     maintenance therapy after first-line chemotherapeutic treatment of metastatic colorectal~     cancer.~   "
113803|NCT02077855|"~     This fracture of the distal tibia occurs in 1 to 4 year-old-children. Timely diagnosis is~     important, because it obviates the need for investigations to archive adequate treatment as~     well as to prevent unnecessary immobilization. The value of sonographic diagnosis of~     toddler's fracture has been demonstrated. The aim of the present study is to investigate the~     reliability and accuracy of sonography in the diagnostic workup of the toddler's fracture.~   "
113804|NCT02077842|"~     The purpose of this study is to determine whether prophylactic nasal continuous positive~     airway pressure (nCPAP) in the post-anaesthesia care unit (PACU) improves post-operative~     pulmonary function following elective bowel surgery. The investigators hypothesize that one~     hour of nCPAP in the PACU will result in a higher partial pressure of arterial oxygen (PaO2)~     when compared to the standard treatment of low flow oxygen applied by face mask.~   "
113805|NCT02077829|"~     The purpose of this study is to examine the barriers and facilitators of implementing Illness~     Management and Recovery (IMR) in Norwegian mental health services.~   "
113806|NCT02077816|"~     This is a pilot study which aims to show the temperatures measured on body surface with an~     infrared thermometer on inpatients who need a central venous catheter (CVC) for medical care.~     Because the local temperature could be altered, at least during local infectious processes,~     seems to be reasonable to think that this approach could be helpful to its early diagnosis.~   "
113819|NCT02077647|"~     The primary objective of this registry is to assess the functional outcome measured with the~     Knee Injury and Osteoarthritis Outcome Score (KOOS) for patients with medial unicompartmental~     osteoarthritis and osteonecrosis of the knee treated conservatively. The aim of the Focused~     Registry is to complete the data collection and enable a sound analysis for the Tomofix Small~     size study.~   "
113807|NCT02077803|"~     The purpose of this study is to assess the bioequivalence (similarity of the drug amount in~     blood among the formulations) of the fixed dose combination (two components combined in one~     tablet) of canagliflozin and metformin extended release (XR) tablet (dose of 2 X 50 mg/1000~     mg) with respect to the individual components of canagliflozin (1 x 100 mg) and metformin XR~     tablet (4 x 500 mg) in healthy fed participants.~   "
113808|NCT02077790|"~     This study is to support the substantial equivalence of the SS-1000 to the predicate device~     Pentacam.~      Primary Objective -The primary objective of the trial is to evaluate the precision of the~     SS-1000 and Pentacam in measuring the anterior segment parameters in an eye, including~     Corneal Curvature, Corneal Thickness, Anterior Chamber Depth and Cornea Volume.~      Secondary Objectives~        -  To investigate the repeatability (intra-instrument) of SS-1000 and Pentacam in measuring~          the anterior segment parameters in an eye~        -  To investigate the reproducibility (inter-instrument) of SS-1000 and Pentacam in~          measuring the anterior segment parameters in an eye~        -  To investigate the agreement between SS-1000 and Pentacam in measuring the anterior~          segment parameters in an eye~      Study design~      -The trial design is a prospective precision trial with the following factors: The trial will~     be conducted at one investigational site. The site will have three SS-1000 devices and three~     Pentacam devices available. Three certified operators (#1, #2 and #3) will be randomly~     assigned to one set of devices (one SS-1000 and one Pentacam), such that operator effect are~     confounded with instrument effect. All participants will have one visit and undergo the same~     set of assessments. Each assessment will consist of 2 consecutive readings (M1, M2).~   "
113809|NCT02077777|"~     The purpose of this study is to obtain an in vivo confirmation that mesalazine induces the~     gene expression of μ-protocadherin and other related genes in the colon mucosa, as~     demonstrated in some in vitro experiments. .~   "
113810|NCT02077764|"~     Objective:~        -  To assess the relationship between coronary allograft vasculopathy (CAV) and graft~          function, and to evaluate non-invasive methods for CAV diagnosis.~        -  To assess left ventricular (LV) and right ventricular (RV) function in the acute phase~          and serially during the first year after transplantation.~        -  To evaluate the impact of acute and repetitive rejection on the longitudinal myocardial~          function Hypothesis~             1. Timing of development and degree of CAV can be measured non-invasively combining~               myocardial longitudinal deformation (by advanced echocardiography) and coronary~               flow velocity reserve (CFVR) (by echocardiography and PET). This combination of~               methods can detect CAV before it is angiographically visual and gives supplementary~               information of the impact on myocardial graft function.~             2. Longitudinal deformation, 3D echocardiography, cardiac magnetic resonance imaging~               (CMRI) and PET can be used for RV and LV myocardial function assessment and~               represent more valid markers of the function than standard echocardiography in~               heart transplant (HTX) patients.~             3. Myocardial longitudinal deformation is a better marker of acute rejections than~               conventional ejection fraction (EF).~      Background The most frequent heart related death causes after HTX are CAV, acute graft~     failure and rejection.~      CAV is characterized by diffuse concentric intima thickening involving both epicardial~     vessels and the coronary microvascular system. In our clinical approach HTX-patients are~     followed with annual CAG and standard echocardiography with estimation of LV systolic~     function by EF. Standard echocardiography has not proven benefit in the diagnosis of CAV. CAG~     often misses CAV in early phases.~      In various cardiac diseases it is well known that ischemia and fibrosis often affect the~     endocardial longitudinal oriented layers. Longitudinal deformation by advanced~     echocardiography has shown to be better markers for systolic function in HTX patients~     compared to standard EF. Longitudinal LV systolic function is dependent of endocardial~     perfusion. CFVR represents the capacity of the coronary circulation to dilate due to~     metabolic demands and has been shown to correlate with longitudinal deformation in myocardial~     infarction. CFVR measurements in HTX patients with advanced echocardiography and PET scan~     have shown a significant correlation to CAV.~      RV failure is an early, potentially fatal, complication to HTX. The function and change over~     time of RV have not been fully studied using modern echocardiographic techniques or~     assessment by CMRI.~      Acute rejection is an inflammatory response often diagnosed by routine biopsies (gold~     standard). These are expensive, time consuming and inconvenient for the patient. The role of~     conventional echocardiography has not yet found a significant role in the diagnostics of~     acute rejections and furthermore how repeated rejections influence on graft function is not~     well described.~      Study 1 A cross sectional study consisting of 50 stabile HTX patients. These will be selected~     with 25 patients with no or light CAV and 25 patients with moderate or severe CAV.~      Severity of CAV will be evaluated by:~        -  CAG~        -  CFVR measurement by advanced echocardiography and PET.~      Graft function will be evaluated by:~        -  Advanced echocardiography at rest end during bicycle exercise.~        -  CMRI including assessment of LV and RV EF, strain and mass.~        -  During rest and bicycle exercise echocardiography simultaneously right heart~          catheterization are performed for hemodynamic measurement~      Study 2 A prospective cohort study with 20-25 newly transplanted patients over a period of 12~     months.~      LV and RV function will be measured by:~        -  Advanced echocardiography~        -  CFVR measurement (echocardiography and PET)~        -  CMRI for LV and RV EF, strain and mass~        -  Right heart catheterization~      Study 3 Prospective examination of correlation between graft function, CAV and rejection.~     Information of former episodes of acute rejection is collected retrospective. Study~     objectives are all living HTX patients (approx. 200) in the period of 2011-2013.~      Advanced echocardiography (including longitudinal deformation), biopsies (rejection~     evaluation) and CAG (CAV evaluation).~   "
113811|NCT02077751|"~     Objective: To gather safety and efficacy BioRBC data from adult subjects who previously~     developed transient BioRBC antibody responses by redosing them and observing for adverse~     clinical or laboratory (i.e., a positive BioRBC antibody titer) outcomes to determine if RBC~     kinetic study results differ from the previous study.~      Hypothesis: BioRBC survival studies performed in adult subjects who previously developed a~     transient BioRBC antibody response will: 1) be associated with no adverse clinical or~     laboratory events; 2) experience a second transient, BioRBC antibody response; and 3) display~     a pattern of RBC survival that is identical to their prior dosing with BioRBCs at the same~     dose.~   "
113812|NCT02077738|"~     The effectiveness, safety and tolerance/comfort of high-frequency chest wall oscillation~     (HFCWO) in prolonged mechanical ventilation patients remain unknown. This study aimed to test~     the hypothesis that HFCWO could produce greater clearance volume of sputum, greater~     improvement rates in serial changes in the chest X-ray (CXR), and greater weaning success~     rates after extubation in Prolonged Mechanical Ventilation (PMV) patients with intra-tracheal~     intubation.~   "
113813|NCT02077725|"~     Title: Measuring the impact of an interdisciplinary polypharmacy clinic within a~     patient-centered medical home~      Objectives:~      The primary objective of this project will be to track the types of interventions made in an~     interdisciplinary polypharmacy clinic to improve medication regimens and medication burden.~     Polypharmacy has been well documented in the literature as a risk for medication errors,~     adverse drug events, and morbidity. Team visits, including complete medication reviews, by~     pharmacists and physicians within a National Committee for Quality Assurance (NCQA) tier 3~     patient-centered medical home (PCMH) at an academic medical center, can improve medication~     regimens. Secondary objectives include (1) measuring each patient's quality of life at~     baseline and one month post-intervention and (2) tracking the cost of medication additions~     and discontinuations.~      Methods:~      Patients taking ten or more chronic medications will be identified for referral to the~     polypharmacy clinic from a report generated from the electronic medical record. The~     polypharmacy clinic will be staffed by a pharmacist and medical resident with oversight from~     an attending physician who specializes in geriatrics. Drug-related problems identified during~     the visit will be resolved and categorized based upon indication, efficacy, cost, safety, and~     compliance. The numbers and types of interventions made, both during the primary visit and~     anticipated in the future, will be tracked. The 12-item short form (SF-12) survey will also~     be administered at baseline and one month post intervention. The increase or decrease in cost~     for medications added and removed during these visits will be captured using the average~     wholesale prices.~      Preliminary Results Using descriptive statistics, the types of drug-related problems~     identified and interventions made will be reported. Changes in quality of life and monthly~     medication costs will also be described.~   "
113814|NCT02077712|"~     2 ug/kg of intranasal dexmedetomidine could produce satisfactory sedation in more children~     for ophthalmic examinations than the sedative effect of 1ug/kg.~   "
113815|NCT02077699|"~     The purpose of this study is to evaluate the efficacy of a treatment with Lactobacillus casei~     DG in the reduction of the painful symptoms in patients affected by irritable bowel syndrome.~     After that, the secondary object is to evaluate if the reduction of painful symptoms is~     related to a relevant reduction of trypsin and tryptase in colonic mucosa.~   "
113816|NCT02077686|"~     This study is a multi-center, randomized prospective trial with a 6-month follow up. A newly~     developed treatment and education module will be tested compared to a waiting-list control~     group. The module covers the topic diabetes and travel. Primary outcome variable is~     diabetes-specific empowerment regarding diabetes and travel. Secondary outcome variables are:~     diabetes-related distress, health-related quality of life, depressive symptoms, self-care~     behavior, and glycemic control.~   "
113817|NCT02077673|"~     Gastroesophageal resection because of gastroesophageal junction (GEJ) adenocarcinoma is a~     massive surgical intervention. Currently, gastroesophageal cancer surgery is performed with~     upper laparotomy followed by thoracotomy at the Department of Surgical Gastroenterology,~     Rigshospitalet, Denmark. However, minimal invasive techniques (MIT), e.g. robotic assisted~     laparoscopy, is in the progress of being implemented in this field as they are hypothesized~     to be more beneficial for the patients, and in some aspects better than conventional~     laparoscopic surgery.~      The operative procedure is often complicated by low blood pressure (systolic blood pressure~     less than 90 mm Hg is experienced in more than 30 % of the patients) and is probably~     accompanied by a reduced splanchnic microcirculatory flow, leading to increased morbidity.~     Hypotension may be due to several factors, among them are epidural analgesia, mesentery~     traction reflex, and inflammatory and vasoactive hormones.~      Aim of the project~      The aim of the project is, through a series of sub-projects, to validate or invalidate the~     relationship between changes in the microcirculatory blood flow in the stomach and the~     systemic hemodynamic changes. Furthermore, the aim is to assess the changes in the~     microcirculatory blood flow as a consequence of the thoracic epidural anesthesia. In~     addition, the aim is to assess the hypothesis that the mesenteric traction reflex and changes~     in the PGI2 levels may influence systemic hemodynamic changes, and that robotic assisted MIT~     will attenuate the mesenteric traction reflex and changes in PGI2 compared to open surgery.~   "
113820|NCT02077634|"~     This is an exploratory Phase 2 multicenter, randomized, open-label study with a randomization~     allocation ratio of 1:1 [abiraterone acetate + prednisone + LHRH-therapy (Arm A) versus~     abiraterone acetate + prednisone (Arm B)]. For both groups patients will receive a dose of~     1000 mg abiraterone acetate and 10mg prednisone daily (QD). Study drug will be administered~     as 4 x 250-mg abiraterone acetate tablets and prednisone will be administered as 5 mg orally~     twice a day (BID). Patients randomized to the LHRH-therapy group will receive the same~     LHRH-therapy they received prior to entering the trial. 70 medically castrated male patients~     with metastatic CRPC who have shown tumor progression and are non- or mildly-symptomatic will~     be enrolled from approximately 12 German study sites.~   "
113821|NCT02077621|"~     PG2 has been approved in Taiwan to treat cancer-related fatigue for advanced cancer patients.~     The primary objective of this study is to evaluate the efficacy of PG2 on fatigue relief in~     patients undergoing palliative abdominal surgery for cancer. The secondary endpoints,~     including the length of hospital stay, postoperative complications, HRQL, inflammatory~     biomarkers, the duration of antibiotic therapy, mortality during the hospital stay, weight~     loss and body composition, will be evaluated among these patients.~   "
113822|NCT02077608|"~     Prospective randomized double blind comparison of hyaluronan enriched embryotransfer media~     and conventional embryotransfer media in human IVF treatments. Embryos selected for transfer~     are incubated in a culture media containing high concentration of hyaluronan or low~     concentration of hyaluronan.~      Primary outcome: implantation and pregnancy rates~   "
113823|NCT02077595|"~     Recently, non-invasive brain stimulation has become a powerful tool in both basic research~     and clinical application. Among several non-invasive brain stimulation techniques,~     transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS)~     have received the most attention. About DC stimulation, the change of polarity could modulate~     the spontaneous neuronal activity and make effect on decision making, language, memory,~     sensory perception, and pain. In spite of that the concept of transcranial alternating~     current stimulation (tACS) is not novel, AC is relatively safe compared to DC, and researches~     have revealed that AC might potentially have the effect on the cortical excitability.~     However, there are still many areas about AC stimulation which remain unknown, such as~     mechanism, application, and potential influence on cortical excitability.~   "
113824|NCT02077582|"~     The objective of this trial is to visualize blood brain barrier function and metabolic~     changes in the first days after ischemic stroke with new investigational MRI sequences.~   "
113825|NCT02077569|"~     To compare the effect of four and a half days treatment of a range of doses of AZD5363 on~     selected markers of the AKT pathway and anti-proliferation compared with placebo in oestrogen~     receptor positive breast cancers.~      To assess the tolerability of four and a half days treatment of AZD5363.~   "
113826|NCT02077556|"~     The purpose of this study is to understand the effects of everolimus on tacrolimus~     pharmacokinetics (pk) in patients receiving de novo kidney transplants.~   "
113827|NCT02077543|"~     The purpose of the study is to determine the innocuity and operability of the innovative~     tumor molecular and cellular print ProTool.~   "
113828|NCT02077530|"~     Patients with metabolic syndrome living in Seoul area are included in this prospective~     registry for more than 10 years. All enrolled patients undergo thorough medical history~     survey. Enrolled patients will have coronary CT, 2D echocardiogram, treadmill test, pulse~     wave velocity, augmentation index, carotid intima-media thickness, and abdominal fat mass~     evaluation. Moreover, lipid profiles and inflammatory markers such as hsCRP, IL-6, TNF-alpha,~     VCAM-1, ICAM-1, adiponectin, MMP-9 will be measured. All participants will repeat the test~     and survey every year in Korea University Hospital.~   "
113829|NCT02077517|"~     The purpose of this study is to compare postoperative complications between hand sewn and~     stapled anastomosis after performing Roux en Y-Gastric Bypass as a treatment for morbid~     obesity.~   "
113830|NCT02077504|"~     The purpose of this study is to determine the correlation between functional MEG analysis of~     the tumor and its periphery and the tumor stage and treatment response.~   "
113831|NCT02077491|"~     The purpose of this study is to determine the effect of a high-protein diet during~     hospitalization in combination with resistance training and a daily protein and energy~     supplement three months after discharge on the muscle mass, muscle strength, functional~     ability and weight in acutely ill old medical patients.~   "
113832|NCT02077478|"~     test the following differences between Schinder's Target Controlled Infusion (TCI ) model and~     manually controlled infusion (MCI) :~        -  remifentanil and propofol total dose given~        -  incidence of awareness or inadequate anesthesia~        -  number of rescue dose given~   "
113833|NCT02077465|"~     This study is to assess the safety, tolerability, and pharmacokinetics (PK) of multiple~     infusions of GS-5745 in participants with chronic obstructive pulmonary disease (COPD) as~     assessed by adverse events (AEs) and laboratory abnormalities.~   "
113834|NCT02077452|"~     The objectives of this study is to determine the safety, tolerability, pharmacokinetics and~     pharmacodynamics of HMS5552 following multiple ascending doses in patients with type 2~     diabetes mellitus.~   "
113835|NCT02077439|"~     The goal of this study is to determine robotic hand system is more effective than~     conventional physical and occupational therapy at promoting functional recovery of the~     affected arm in subjects after stroke.~   "
113836|NCT02077426|"~     The aim of this study is to determine whether heart failure patients can tolerate a~     four-weeks of a new exercise training regimen that targets peripheral tissues (Regional~     Specific Training Stimulus-RSTS) and has been show to produce significant benefits in aerobic~     capacity and strength in healthy subjects aged 70+years who were at risk for losing~     functional independence.~   "
113867|NCT02077023|"~     The purpose of the study is to estimate the contemporary prevalence of cardiovascular~     diseases in the United Kingdom (UK) and to describe the incidence and prevalence of stroke,~     mini stroke (TIA), Heart Attack (MI), deaths and interventions repairs for carotids and~     occlusive arterial disease in a large population. This study will also allow us to obtain~     reliable information on the age- and sex-specific relevance of tobacco and alcohol~     consumption, obesity, diabetes and blood pressure as risk factors for different~     cardiovascular diseases. By following up a large group of participants for 5 years, we will~     be able to estimate the annual risk of stroke and other CVD events associated with~     asymptomatic carotid artery stenosis and atrial fibrillation.~   "
113837|NCT02077413|"~     The overall goal of this study is to establish a new pre-rehabilitation program in the~     prevention of muscle injury in the legs of healthy people serving in the military and injured~     individuals with muscle wasting following leg injuries. The specific goals include: 1) the~     amount of exercise that causes injury to healthy muscle in the lower leg of healthy people;~     2) what is the effect of an intervention (pre-rehabilitation program) on decreasing how~     easily the muscle of the lower leg can be injured in healthy people; 3a) what amount of~     exercise causes injury to muscle that has recently been injured and is recovering and 3b) the~     effect of the new pre-rehabilitation program on the muscles of the lower leg when the muscle~     has recently been injured and is still recovering.~      For the first goal, the investigators will determine how easily the muscle can get injured~     from a specific exercise in 6 healthy, conditioned men and women. Participants will perform~     different amounts of exercise with the lower leg muscles to see how easily the muscle can be~     damaged. Magnetic resonance imaging (MRI) will be used to estimate how much damage occurs~     with the different levels of exercise. For the second goal, the investigators will examine~     the effect of a new pre-rehabilitation program on decreasing how easily muscle gets damaged~     from the exercise we did in the first goal. The investigators will invite healthy people to~     participate in this goal. The investigators will use MRI, blood markers, and pain as ways of~     assessing muscle damage in 10 people who do the pre-rehabilitation program before exercising~     and 10 who do not do the new program. The third goal will focus on a) determining how easily~     muscle gets injured that has recently recovered from some trauma (5 people will participate~     in this part of the third goal), and b) determining how a pre-rehabilitation program~     decreases how easily a muscle that has just recovered from trauma gets injured from exercise~     (10 people will participate in this part of the third goal).~   "
113838|NCT02077400|"~     Fingertip amputation is a common injury. Considerable controversy exists as to whether~     prophylactic antibiotics are necessary for this injury. The investigators goal was to compare~     the rate of infections among subgroups with and without prophylactic antibiotic treatment.~     The study hypothesis was that infection rates were similar in the two groups.~   "
113839|NCT02077387|"~     Today's environment provides many hedonic stimuli that promote consumption of unhealthy~     energy-dense snack foods. It is widely recognized that a systems approach is required to deal~     with this complex problem. However, individuals, particularly children, also need to develop~     the personal capacity to deal with tempting stimuli and inhibit responses to these~     energy-dense foods. Therefore in this proposal, we will focus on enhancing higher level~     executive functions, particularly inhibitory control, which is needed to counterbalance~     impulsive behavior and is crucial for growth and development. We have chosen to focus on~     developing inhibitory control in preschool-age children because executive~     functioning/inhibitory control and eating habits are developing at this time. Among~     preschool-age children, inhibitory control is fostered through social play-based curriculums~     and has been found to be related to greater school readiness and academic skills. Therefore,~     the goal of this proposal is to adapt a play-based curriculum, the Tools of the Mind program,~     to promote greater inhibitory control skills in preschool children and decrease consumption~     of energy-dense snack foods. In Phase I, we will develop and pilot a Child Inhibitory Control~     Play-based Program (CHIC Play) among children age 4- to 6-years old. We will adapt the~     learning tools used in the Tools of the Mind curriculum and employ naturalistic play~     scenarios, drawings (visual support), and games to teach children to inhibit their responses~     to energy-dense snack foods. Once developed, we will test the efficacy of CHIC Play in the~     preschool setting. Parent groups will also be conducted to support the adoption of these~     skills at home. The primary outcome of interest is caloric intake and age- and~     gender-adjusted percent of daily caloric intake as measured by the Eating in the Absence of~     Hunger (EAH) free access procedure and a snack time procedure. Inhibitory control skills will~     also be measured using executive functioning tasks. Feasibility and acceptability of this~     program will be determined from parent, child, and teacher surveys. The purpose of this study~     is to develop a new innovative method of decreasing energy-dense snack food consumption by~     promoting the development of inhibitory control or impulse control. If successful, this~     program has the potential to play a role in the treatment and prevention of childhood~     obesity.~   "
113840|NCT02077374|"~     The purpose of this study is to determine the safety and efficacy of IDN-6556 compared to~     placebo in patients with diagnosed fat deposits in their liver (not caused by alcohol) and~     with abnormal liver tests~   "
113841|NCT02077361|"~     A project has been developed in Edmonton, Alberta, Canada to enable male patients with~     choroideremia to access a clinical trial that replaces the defective gene with a normal copy.~     This experiment is designed to show that the transfer of a normal copy of the gene to the eye~     is not only safe but may improve the sight of patients. Only Canadian subjects who meet~     criteria will be recruited.~   "
113842|NCT02077348|"~     Diabetes mellitus type I (DM I) is characterized by lack of endogenous insulin and these~     patients are 100% dependent on insulin substitution to survive.~      Insulin is a potent anabolic hormone with its primary targets in the liver, the skeletal~     muscle-tissue and - adipose-tissue.~      Severe lack of insulin leads to elevated blood glucose levels, dehydration, electrolyte~     derangement, ketosis and thus eventually ketoacidosis.~      Insulin signalling pathways are well-known.~      Growth hormone (GH) is also a potent anabolic hormone, responsible for human growth and~     preservation of protein during fasting. GH (in concert with lack of insulin) induces~     lipolysis during fasting. It is not known how GH exerts its lipolytic actions.~      The aim is to define insulin and growth hormone (GH) signalling pathways in 3 different~     states in patients with DM I.~      And to test whether ATGL-related lipolysis in adipose tissue contributes to the development~     of ketosis.~        1. Good glycemic control~        2. Lack of insulin (ketosis/ketoacidosis)~        3. Good glycemic control and GH injection~   "
113843|NCT02077335|"~     The purpose of this study is to determine the clinical efficacy and toxicity of High-dose~     rate (HDR) brachytherapy as monotherapy for the treatment of low risk and intermediate risk~     prostate cancer.~   "
113844|NCT02077322|"~     Functional endoscopic sinus surgery (FESS) is the best method of surgically treating patients~     who suffer from sinus disease. Synechiae formation in the nose is the most common~     complication after sinus surgery. Synechiae describes the adhesion of two opposing mucosal~     surfaces in the nasal cavity that can cause scarring and obstruction of the nasal passage.~     Spacers are often inserted during surgery between nasal mucosal surfaces to prevent~     synechiae. The aim of this study is to see if a silastic spacer is more effective at reducing~     the formation of synechiae after sinus surgery than a merocel spacer.~   "
113845|NCT02077309|"~     Examination of the effect of Linagliptin versus placebo for 6 months on vascular inflammation~     of the carotic artery and on abdominal adipose tissue inflammation in patients with diabetes~     mellitus type 2. The effect will be assessed by FDG-PET scan.~      Furthermore the effect of Linagliptin on the vessel wall volume of the carotid artery will be~     assessed by MRI scan and biomarkers of vascular inflammation will be analyzed in blood~     samples.~   "
113846|NCT02077296|"~     Rationale and background: Predictive factors are needed to discriminate chemoradiotherapy~     responders from non-responders and to individualize the treatment regime. Various cytokines~     play a role in processes affecting tumour growth and metastasis. Furthermore, cytokines might~     influence treatment response. Various cytokines are abnormally expressed in colorectal cancer~     patients, are associated with colorectal cancer or determine response to chemoradiotherapy.~     Therefore the investigators want to investigate whether levels of circulating cytokines could~     predict response to preoperative chemoradiotherapy in patients with rectal cancer.~      Hypothesis: The investigators hypothesis is that the varying levels of circulating cytokines~     in the blood of rectal cancer patients may predict the response to preoperative~     chemoradiotherapy.~      Study design: This study is an explorative clinical pilot study in which the investigators~     will collect 4 ml of blood from a selection of rectal cancer patients during a regular~     venipuncture before, during and after preoperative chemoradiotherapy and before and after~     surgery. Cytokines will be measured in blood plasma and in tumour and healthy tissue from the~     resection specimen using multiplex immunoassays. Plasma cytokine measurements will be linked~     to pathological response to identify which cytokines and corresponding levels can predict~     response to preoperative chemoradiotherapy for patients with locally advanced rectal cancer.~     Furthermore, blood plasma cytokine measurements before and after surgery will be compared to~     evaluate the effect of tumour resection on the immune response. In addition, preoperative~     blood plasma cytokine levels will be compared with cytokine levels in normal and tumour~     tissue to test whether circulating cytokine levels are representative for tissue cytokine~     levels.~      Study population: Thirty patients (≥18 years) with locally advanced rectal adenocarcinoma~     eligible for preoperative chemoradiotherapy (oral capecitabine and 45-50 gray (Gy) in total;~     fractions of 1.8-2 Gy) and surgery.~      Country of recruitment: The Netherlands~   "
113847|NCT02077283|"~     NAFLD(non-alcoholic fatty liver disease, NAFLD) is a common liver disease with a high~     morbidity which seriously influence people's health. In clinical, there are two major~     Traditional chinese medicine(TCM) patterns which are the pattern of liver depression and~     spleen deficiency and pattern of damp-heat in the interior, According to TCM patterns, the~     treatment is effective, but not used worldwide. While the development of metabonomics~     provides a tool to investigate the correlation of TCM patterns and metabonomics which will~     promote the further development of TCM.~      Currently researches on NAFLD patterns based on metabolomics were limited. Our study was~     undertaken to investigate the correlation of TCM patterns and metabonomics, to evaluate the~     application of urinary metabonomics in NAFLD: whether it can be used in TCM patterns~     auxiliary classification of NAFLD. In addition, the investigators also aim to discover novel~     biomarkers for the noninvasive early diagnosis of nonalcoholic fatty liver disease (NAFLD).~      In this study, urine samples from humans of three divided groups (healthy controls, the group~     of liver depression and spleen deficiency pattern and group of damp-heat in the interior~     pattern) were collected, then 4℃, 15 min 3000 rpm centrifuged and - 80℃ cryopreserved. The~     metabolic profile changes were analyzed by Gas Chromatograph-Mass Spectrometer(GC/MS) with~     principal component analysis (PCA), partial least squares-discriminate analysis (PLS-DA) and~     orthogonal partial least squares-discriminate analysis (OPLS-DA). Furthermore, biochemical~     examination were also carried out to compare among these three groups.~      Base on literature survey, the investigators inferred that there should be metabolic~     differences between the two patterns of NAFLD. If the investigators hypothesis is correct,~     the investigators can find different metabolites which can be used discriminate between NAFLD~     and healthy population, different patterns through urinary metabonomics.~      The results will be attractive which mean a lot: it will prove the importance of the four~     diagnosis methods of TCM used in differential analysis by metabonomics; it will validate the~     classification of TCM syndromes is scientific; it will shed light in the study of TCM~     syndromes; it will find biology markers to help diagnosis, treatment and pattern~     discrimination.~   "
113848|NCT02077270|"~     The main hypothesis is that performance of electroacupuncture before colonoscopy reduces pain~     during the exam.~   "
113849|NCT02077257|"~     This is a 12-week, randomized, open-label,,multicenter, Phase IV study exploring LDL-C~     lowering efficacy of Rosuvastatin 20 mg/d compared to 10 mg/day Chinese ACS patients.The~     Randomized Treatment Period is preceded by a 24hours Screening Period. The study flow chart~     (Figure 1) depicts the 2 periods which comprise the study. These periods are described as~     follows:~        1. Screening Period (Day -1 through Day 1) This period consists of Visits 1 and 2. Subjects~          entering the Screening Period are required to meet the inclusion criteria. All subjects~          will be instructed to follow the current TLC(therapeutic lifestyle change)dietary~          guidelines for the duration of the trial.~        2. 12-week Randomized Treatment Period (Day 1 through Week 12) This period consists of~          Visits 2, 3, 4, and 5. Eligible subjects will be randomized at Visit 2 to each treatment~          group: Rosuvastatin 20 mg orRosuvastatin10 mg. Treatment will be administered once daily~          for 12 weeks.~      A total of 450valid subjects in each of the Rosuvastatin arms are required, in order to test~     the hypothesis of superiority for comparison of LDL-C levels between Rosuvastatin20 mg and~     Rosuvastatin10 mg(see Section 6.1 for more details).~      The Study visit schedule(Table 2) indicates the number and timing of the planned visits. The~     visit schedule must be within time window. At the final visit, it is the responsibility of~     the investigator to ensure the subject is offered an selected appropriate type of~     lipid-lowering therapy.~      Scheduled Visit3,4,5 will have a visit window of ±2 days. Subjects who attend a clinic visit~     without fasting (at least 12 hours) should be asked to return within 2 days for another~     clinic visit after fasting for at least 12 hours.~   "
113850|NCT02077244|"~     To investigate the effect of nurse led follow up talks to prevent posttraumatic stress (PTS)~     symptoms and improve quality of life after an intensive care unit (ICU) stay.~      Secondly:~      Investigate level of psychological distress, quality of life, hope and work participation in~     ICU patients after an ICU stay and factors associated with these outcomes.~   "
113851|NCT02077231|"~     Most of the patients under long application of anti-glaucoma eyedrops endure severe ocular~     surface irritation, which interrupt their quality of life a lot. Lots of studies aimed to~     search for new drugs for therapy. The investigators hypothesized that the artificial tears~     containing vitamin A or carbomer may be a great substitute. Both of the two drugs were in~     common use and had already been tested in animals.~   "
113852|NCT02077218|"~     This pilot clinical trial studies computed tomography (CT) scans and biomarker analysis in~     diagnosing coronary artery disease (CAD) in patients who have undergone a stem cell~     transplant but have no symptoms of CAD. CAD is a disease in which there is a narrowing or~     blockage of the coronary arteries (blood vessels that carry blood and oxygen to the heart)~     and patients who have undergone a stem cell transplant are at an especially high risk for~     CAD. A CT scan involves a series of detailed pictures of areas inside the body taken from~     different angles. The pictures are created by a computer linked to an x-ray machine. Studying~     samples of blood from patients who have undergone a stem cell transplant in the laboratory~     may help doctors identify and learn more about biomarkers related to CAD. Using a CT scan in~     combination with biomarker analysis may be a better and less-invasive way to diagnose CAD.~   "
113853|NCT02077205|"~     Manualised Cognitive Behavioral Therapy for children and adolescents with anxiety disorders~     is evaluated in a routine care setting to evaluate the efficacy of the intervention. Children~     and adolescents receive manualized Cognitive Behavioral Therapy for anxiety disorder.~      It is expected, that the intervention will result in less anxiety / lower scores on the~     primary and secondary outcome measures.~   "
113854|NCT02077192|"~     The purpose of this study is to determine whether fostamatinib is safe and effective in~     treating patients with persistent/chronic Immune Thrombocytopenic Purpura (ITP) over a 2 year~     period.~   "
113855|NCT02077179|"~     Recent Canadian studies, public opinion polls and the Canadian Heart Health Strategy and~     Action Plan state that women's heart health is a key national priority; it should be~     addressed through improving heart health awareness and prevention, and reducing care~     inequities for women in general and younger women in particular. The investigators have~     developed an innovative and interactive mobile website based postpartum lifestyle~     modification program (regular physical activity and nutritional guidance), based on~     established national guidelines, to improve heart disease risk factors in women. The~     investigators will conduct a trial to determine if the mobile website based lifestyle~     modification program can be maintained and reduces a collection of risk factors, which~     occurring together, greatly increases the risk of developing heart disease. The investigators~     hypothesize that the interactive mobile website directing regular physical activity and~     personalized nutritional guidance, compared to standard postpartum care, will be motivational~     and result in a reduced modified metabolic syndrome z score at 8 months postpartum among the~     intervention group.~   "
113856|NCT02077166|"~     This Phase 1b/2 study is designed to assess the safety and efficacy of ibrutinib in~     combination with lenalidomide and rituximab in subjects with relapsed/refractory Diffuse~     Large B-Cell Lymphoma (DLBCL) not eligible for transplant.~   "
113857|NCT02077153|"~     Reminiscence group therapy is a brief and structured intervention that has been shown to be~     effective for improving well-being among older adults. Reminiscence helps accepting the~     ageing process by solving unresolved issues and past losses; the group setting empowers the~     efficacy of the process by giving back to elderly a way to manage their skills in a wider~     setting and interact with other people. The sharing of memories reinforces the identity~     through active tasks, preparing individuals to cope with the final part of the life. However,~     considering reminiscence interventions for older populations, controlled trials adopting~     better inclusion/exclusion criteria, standardized measures, and different conditions for~     comparing the effect are needed.~      According to this premise, the trial presents the design of a randomized controlled aimed at~     comparing group reminiscence therapy with a group recreational activity in a older~     population. It includes two groups of approximately 20 hospitalized elderly: (1) the~     Experimental Group, (2) the Control Group. Participants included in the Experimental Group~     will receive a group reminiscence therapy of six sessions, while the Control Group will~     participate in a recreational group discussion. Between design with repeated measures will be~     used to evaluate changes in self-reported outcome measures of depressive symptoms,~     self-esteem, life satisfaction, quality of life across baseline, post-intervention and three~     months post-intervention.~      What the investigators would like to show with the present trial is the efficacy of a group~     reminiscence intervention in a hospitalized population of older adults: focusing on specific~     past events and re-living them in a group environment may enhance the self-esteem and quality~     of life better than a simple group discussion.~   "
113858|NCT02077140|"~     The purpose of this study is to evaluate the efficacy and safety of MDT-10013 in men and~     women 18 to 80 years of age who are undergoing bunionectomy. The primary objective is to~     determine the analgesic efficacy of MDT-10013 compared with standard of care in the treatment~     of acute postoperative pain after subjects undergo bunionectomy.~   "
113859|NCT02077127|"~     The pathogenesis of proliferative diabetic retinopathy (PDR) remains poorly understood.~     Recent studies have implicated that monocyte chemoattractant protein-1 (MCP-1) is associated~     with diabetic microvascular or macrovascular complications. However, the relationship between~     SNP polymorphism c.2518A/G in the MCP-1 gene with diabetic retinopathy remains controversial.~     In the present study, we evaluated the association of a single nucleotide polymorphism (SNP)~     in the MCP-1 gene with diabetic retinopathy (DR) and diabetic macular edema (DME) in Chinese~     population from Southern China with type 2 diabetes.~   "
113860|NCT02077114|"~     The purpose of the study is to assess whether a vaccine containing a small fragment of the~     protein IDO, which may be present in cancer cells and cells of the immune system, is safe to~     use in combination with either Ipilimumab or Vemurafenib in the treatment of malignant~     melanoma that has metastasized.~   "
113861|NCT02077101|"~     The main objective of the study is to assess the acceptability of a future therapeutic~     vaccine against HIV in patients living with HIV-1.~      Secondary objectives concern the validation of a specific questionnaire for self-perception~     and acceptability of therapeutic vaccination against HIV-1 (RAVVIH), the development of a~     composite score for acceptability based on this questionnaire, and the analysis of critical~     factors related to: representations of vaccination in general, representations of therapeutic~     vaccination specific to HIV, perception of disease severity, health-related quality of life,~     doctor-patient relationship.~   "
113862|NCT02077088|"~     Addition of prebiotic galactooligosaccharides to hypoallergenic starter formula would lead to~     decreased allergic (atopic) symptoms in nonbreastfed infants with a positive history of~     allergy in family~   "
113863|NCT02077075|"~     This research is collecting data to determine the benefits of a web-based wellness program~     designed to improve the health and well-being of individuals in the workplace. Participants~     will be invited to participate in a web-based Healthy Weight Program. The program is designed~     to optimize health and wellbeing by promoting physical activity and healthy eating.~   "
113864|NCT02077062|"~     Prospective non-randomized trial to study expression of mediators of post hepatectomy liver~     regeneration (PHLR) and compare with a non-hepatectomy group: a pilot study Background :~     Experimental studies using post hepatectomy animal models have been used to study the~     mechanism of liver regeneration. Hepatectomy for various diseases and living donor liver~     transplant provide a good human model to study in vivo mechanism of liver regeneration. These~     studies are necessary for the clinical application of the knowledge obtained by animal~     experiments and will guide further research to develop new modalities for the management of~     hepatic failure, cirrhosis and cancer.~      Null hypothesis: Expression of mediators of post hepatectomy liver regeneration (PHLR) is not~     different between hepatectomy (study group) and non hepatectomy group (control group).~      Aim: To study the mechanism of post hepatectomy liver regeneration(PHLR) and compare~     expression of mediators of PHLR between hepatectomy (study group) and a non-hepatectomy group~     (control group).~      Patient and method: This prospective non randomized trail will be conducted on two group of~     patients- hepatectomy (Study) group and non-hepatectomy (control) group and minimum 10~     consecutive adult (18 year or more) patients will be recruited in each group according to~     inclusion and exclusion criteria given below. Informed consent will be obtained from the~     patients in both the groups. Peripheral (from a forearm vein) venous blood (6 ml) will be~     collected a day before surgery and at different intervals after surgery (day 1, day 3,7, 2~     weeks, 6 weeks and 6 months). A small branch of portal vein will be cannulated a 20 gauge~     intravenous catheter for measurement of portal pressure and collection of portal venous blood~     (6 ml) at the start (after entry inside the abdomen) and at the end (before closure of the~     abdomen). Patients in hepatectomy (study) group will undergo trucut (needle) biopsy from the~     remnant liver. Mediators of liver regeneration will be measured by standard methods in blood~     samples from both groups. The liver tissue from study group will also be analysed for factors~     related to initiation of PHLR.~   "
113865|NCT02077049|"~     The main objective of this study is to determine whether elderly people in rehabilitation~     setting show higher adherence to self-training when using computer-based-learning games (i.e.~     the so called serious games) than when performing conventional exercises. Secondly the study~     explores to which extend balance and mobility performances vary according to the mode of~     self-training.~      The primary study hypothesis is that elderly people practice longer and more frequently with~     serious games than with a conventional exercise booklet. The secondary hypothesis is that~     patients experience a significant higher improvement in their balance capacity by using~     serious games compared to patients performing conventional exercises.~   "
113866|NCT02077036|"~     The overall aim of the study is to investigate the effect of a new, non-pharmacological~     method that may alleviate the symptoms of narcolepsy and thereby lead to a reduction in the~     use of medications with potentially serious side effects in patients with this disease.~   "
113875|NCT02076919|"~     The purpose of this first-in-human study is to assess the local ocular and systemic safety~     and tolerability of LHA510 eye drops when administered at various concentrations and dosing~     frequencies.~   "
113876|NCT02076906|"~     The purpose of this study is to determine if Magnetic Resonance guided High Intensity Focused~     Ultrasound ablative therapy is safe and feasible for children, adolescents, and young adults~     with refractory or relapsed solid tumors.~   "
113868|NCT02077010|"~     Patients with end stage heart failure have significant symptoms (including fatigue and~     shortness of breath) which prevent them from being able to perform most activities of daily~     living. Milrinone is one of the inotropic medications that has been studied and used in the~     treatment of end stage heart failure. End stage heart failure patients awaiting a heart~     transplantation often have to be maintained on IV milrinone 24 hours a day through a chronic~     IV line. Two problems arise with this therapy. First, the IV line itself creates an~     opportunity for infection and blood clots, in addition to interfering with patient's quality~     of life. Second, patients may be exposed to higher levels of milrinone when given IV than are~     necessary for maintaining their heart's function.~      The investigators goal is to show that inhaled milrinone is equivalent to standard of care~     IV milrinone in improving heart and lung pressures in end stage heart failure patients (who~     respond to milrinone therapy) in a prospective, randomized, controlled clinical trial.~     Patients who are sent for a right heart catheterization procedure by their cardiologist to~     determine if they require milrinone will be randomly chosen to be in the continuous IV~     milrinone group or the inhaled milrinone group after agreeing to participate in this study.~     Patients in the inhaled milrinone group will receive 60mg in 4ml of fluid inhaled by a jet~     nebulizer every 8 hours. Patients in the IV arm will receive a constant IV infusion rate.~     Both groups will have a standard-of-care repeat right heart catheterization procedure an~     average of 48- 96 hours after milrinone initiation to evaluate their response to milrinone.~     Afterward, all patients that respond will be placed on the standard of care IV milrinone for~     the duration of their therapy, as directed by their cardiologist.~   "
113869|NCT02076997|"~     Pediatric cancer patients are being asked to take part in this study who have a cancer that~     is treated with high doses of the drug methotrexate (MTX). In addition, these patients have~     either had significant side effects to methotrexate in the past or their doctor thinks that~     they are at high risk for side effects from receiving methotrexate. Methotrexate is a~     cancer-fighting drug that is very important in the treatment of leukemia.~      In this study, investigators are testing a new method of giving high dose methotrexate to~     cancer patients which may reduce the chances that the level of methotrexate in the blood is~     too high. When the levels are too high this is thought to lead to an increase in side~     effects. Side effects are unintended and unwanted results of treatment.~      The initial ordered amount of methotrexate and the period over which methotrexate is given~     will not change from the current standard of care (meaning what is usually done by doctors,~     and would likely be done if the patient was not on this study). This study is testing a new~     method of monitoring and potentially adjusting the final amount of methotrexate that the~     patient will end up receiving based on levels of methotrexate in the blood in the first 24~     hours in order to try to prevent side effects in patients with a previous history of side~     effects from methotrexate or who are at high risk for having side effects.~      On this study the investigators will check methotrexate levels in the blood 2 hours after the~     patient starts receiving the drug and the investigators will lower the dose of methotrexate~     if needed. Investigators will do the same thing again 6-8 hours later.~      Investigators will also collect an optional blood sample from the patient because the~     investigators want to study how genetic (DNA) differences are involved in how the body~     processes methotrexate.~   "
113870|NCT02076984|"~     Background: Laparoscopic repair of ventral hernias has gained popularity, since many studies~     and a recent meta-analysis have reported encouraging results and recurrence rates similar to~     open repair. The choice of the mesh and fixation methods is of paramount importance during~     laparoscopic approach, and nowadays, lightweight macropore meshes specifically designed for~     laparoscopic approach represent the first choice in several studies, due to the biomechanical~     properties and the optimal integration into the abdominal wall. No data with statistical~     relevance exist on the choice of fixation methods.~      Primary end point of the present Italian multicentric prospective randomized trial is to~     evaluate the safety and effectiveness of two different tacks to fix the lightweight~     polypropylene mesh (Physiomesh™) during laparoscopic incisional hernia repair: metallic~     spiral tacks (Protack™) vs absorbable U shaped tacks (Securestrap™)~      Design of the Study: 200 patients with ventral hernia will be randomized into two groups:~      Group A patients will be submitted to laparoscopic repair by Physiomesh fixed by Protack;~     Group B patients will be submitted to laparoscopic repair by Physiomesh fixed by Securestrap.~      Blind randomization will be guaranteed by an on-line software with specific key access for~     every surgical unit participating in the study. Patients demographics and characteristics,~     preoperative studies, intraoperative and postoperative results and complications, as well as~     scheduled follow-up will be recorded and uploaded to the database. Data represented by~     continuous variables will be expressed as arithmetic mean +/- standard deviation. Other data~     will be expressed as geometric mean +/- 95% confidence interval. Data representing low~     incidence events will be expressed as number and percentage of occurrence for each group.~     Statistical significance for all analyses will be indicated by a p value of 0.05 or less.~   "
113871|NCT02076971|"~     The purpose of this study is to determine the sensitivity and specificity of QuantiFeron® and~     ImmuKnow® in combination for early detection of patients who will develop CMV infection in~     lung transplant patients with CMV-positive serology (R+) prior to transplant.~   "
113872|NCT02076958|"~     The aim of the proposed project is to identify an optimal implementation strategy using a set~     of evidence-based interventions that aim to increase early detection of breast, prostate, and~     colorectal cancer among African Americans as a model. These three interventions will be~     packaged and interwoven into a single branded project, Project HEAL (Health through Early~     Awareness and Learning) which will be delivered through trained Community Health Advisors~     (CHA) in African-American church settings. The implementation and sustainability will be~     evaluated using the RE-AIM Framework. Fourteen African American churches in Prince George's~     County, MD will be randomized to a traditional classroom training approach or an online~     training approach, in which the CHA training approach and level of technical assistance is~     varied (in-person classroom training of CHAs + monitoring/evaluation + technical assistance~     and training vs. online training of CHAs + monitoring and evaluation only, respectively). By~     varying the training methodology and level of technical assistance, we will be able to~     determine what level of technical assistance leads to successful implementation and~     sustainability. We will also identify church organizational capacity characteristics that~     lead to successful implementation and sustainability. The specific aims of this research are~     to: (1) Package the three interventions into a single branded project (Project HEAL), develop~     a local cancer screening resource guide, and pilot test the materials and training. (2)~     Implement Project HEAL in 14 churches in Prince George's County, Maryland. We will evaluate~     the implementation outcomes involving treatment fidelity and identify church organizational~     capacity characteristics that led to successful implementation. We will compare the two~     implementation strategies (traditional vs. online) to determine the optimal level of~     technical assistance necessary for successful implementation. (3) Evaluate the sustainability~     of Project HEAL over a two-year period of time. We will identify church organizational~     capacity characteristics that led to sustainability, and compare the two implementation~     strategies (traditional vs. online) to determine the optimal level of technical assistance~     for successful sustainability.~   "
113873|NCT02076945|"~     Background Between 25 and 55% of diabetic patients develop neuropathy secondary to~     hyperglycemia. High resolution bedside ultrasound has been demonstrated to be a useful tool~     to detect the presence of neuropathy prior to block performance, by measuring the~     cross-sectional area of the posterior tibial nerve: a value superior to 19.01 mm2 at a~     distance of 3 cm above the medial malleolus has an optimal threshold value for identification~     of diabetic sensorimotor polyneuropathy.~      Animal data showed that duration of sciatic nerve block with local anesthetics is longer in~     diabetic rats compared with non-diabetic rats. Characteristics of a peripheral nerve blockade~     in humans with diabetic sensorimotor neuropathy are unknown.~      Aim The aim of this study is to compare duration of analgesia and other characteristics of an~     ultrasound-guided popliteal sciatic nerve block between diabetic patients with neuropathy,~     diabetic patients without neuropathy and non-diabetic patients without neuropathy, based on~     the ultrasound-measured cross-sectional area of the posterior tibial nerve.~      Hypothesis We hypothesize that diabetic patients with neuropathy will have a duration of~     analgesia lasting 50% longer than patients without neuropathy.~      Methods This will be an observational study on diabetic and non-diabetic patients, with and~     without peripheral neuropathy, based on the ultrasound-measured cross sectional area of the~     posterior tibial nerve 3 cm above the medial malleolus (cut-off value, 19.01 mm2)~      All patients will receive ultrasound-guided sciatic nerve block with 30 mL1:1 mixture of~     lidocaine 1% and bupivacaine 0.5%, with the needle tip positioned at the bifurcation of the~     sciatic nerve in peroneal and tibial nerve, below the common fascia or paraneurium. Block~     success will be confirmed by loss of sensation to pinprick in the distribution of the common~     peroneal and tibial nerves 30 minutes following local anesthetic injection. This procedure~     will be completed by a saphenous nerve block. Postoperative pain management will be~     standardized.~      Pain and block-related endpoints will be collected such as onset time of action of sensory~     and motor blockades, duration of analgesia, pain scores and opiates consumption among others.~      Relevance Defining the duration of analgesia in case of diabetic neuropathy will help~     regional anesthesiologists to better define the type and doses of drugs that will be injected~     and to better prescribe the postoperative multimodal analgesic treatment.~   "
113874|NCT02076932|"~     The purpose of this study is to determine if physical exercise reduces the adverse changes in~     adipose tissue metabolism and insulin sensitivity that occurs in women during the menopausal~     transition.~   "
113877|NCT02076893|"~     Tonsillectomy is the most common pediatric surgical procedure performed in the US, with over~     530,000 procedures performed annually in children under 15 years (Baugh et al., 2011). The~     postoperative period can be particularly painful. A recent clinical consensus acknowledges~     there is no standard analgesic protocol, and calls for further research comparing~     postoperative pain medications (Baugh et al., 2011). Tramadol was found to be as effective as~     codeine with few reported side effects in a recent double-blinded, controlled trial conducted~     by the investigators at Children's Hospitals and Clinics (CHC), and it is currently being~     prescribed in the postoperative setting. However, despite its effectiveness for pain control,~     there were some children that continued to report pain during the 10-day follow-up period. In~     response, the investigators will conduct a randomized, double-blinded controlled trial to~     determine whether or not adding scheduled gabapentin to a scheduled tramadol + as needed~     (PRN) ibuprofen regimen provides better pain control than tramadol + ibuprofen PRN alone~     during the post-tonsillectomy period. Using a 10-day take-home diary, caregivers will be~     asked to record daily information about their child's postoperative pain and other core~     outcomes and domains as recommended in the recent consensus statement put forth by the~     Pediatric Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials~     (IMMPACT) (McGrath et al., 2008). This study will offer new information regarding the~     efficacy and side effects associated with adding scheduled gabapentin to a postoperative pain~     management protocol in a pediatric population.~   "
113878|NCT02076880|"~     Sleeve gastrectomy is a restrictive procedure based on the removal of a large part of the~     gastric fundus. According to a recent randomized study, weight loss and resolution of~     diabetes are comparable to that obtained after gastric by-pass (79.7 % versus 80.3%), but~     with a lower morbidity. The mechanisms involved in the rapid resolution of diabetes after~     sleeve gastrectomy remain poorly understood, as no specific study in patients with type 2~     diabetic obese are available. An increase in post- absorptive levels of Glucagon-like Peptide~     1(GLP-1), Peptide YY(PYY) and insulin has been reported, but in non-diabetic subjects mostly.~     The important caloric restriction in the early postoperative period indeed improves hepatic~     insulin resistance, regardless of weight loss. Specific metabolic and hormonal effects of~     this surgical procedure cannot be excluded.The aim of our study is to explore the early and~     late metabolic effects of sleeve gastrectomy in severely obese patients with~     non-insulin-treated type 2 diabetes. We will also evaluate insulin sensitivity, insulin~     secretion and incretin effect. We will include 14 obese patients with type 2 diabetes,~     considered eligible to bariatric surgery according to HAS criteria, and whose diabetes~     treatment involves only metformin, sulfonylurea and glinides. They will be randomized to a~     1-week caloric restriction period or no caloric restriction, immediately before surgery. Test~     meals with dosages of blood glucose, insulin, C-peptide, adiponectin, leptin, GLP-1, PYY and~     ghrelin will be performed before and after caloric restriction, and 1 week, 3 month, 6 month~     and 12 month after surgery.~   "
113879|NCT02076867|"~     The purpose of this study is to compare the effectiveness of Intensive Short-Term Dynamic~     Psychotherapy (ISTDP) plus Medical Care As Usual (MCAU) compared to MCAU for Somatic Symptom~     and Related Disorders (SSRD). Consenting patients presenting to the emergency department with~     suspected SSRD will be randomly allocated to receive either 8 weekly individual sessions of~     ISTDP or to an 8-week wait list followed by ISTDP. MCAU including emergency department and/or~     family doctor consultation is available throughout trial participation. The primary outcome~     measure is participant self-reported somatic symptoms at week 8.~   "
113880|NCT02076854|"~     The aim of this study is to pilot an innovative motivational text-message intervention for~     individuals with anorexia nervosa and subthreshold anorexia nervosa. Patients will receive~     personalized motivational text-messages as an adjunct to cognitive behavioral therapy (CBT).~     CBT will be provided to patients at no cost for the duration of the study. The investigators~     hypothesize that the text-messages will help increase motivation to change and kilocalorie~     intake and decrease eating disordered behavior.~   "
113881|NCT02076841|"~     To evaluate treatment tolerability, adherence and quality of life (QoL) over 1 year in MS~     (Multiple Sclerosis) participants who have been switched - due to persistent tolerability~     issues, particularly injection problems - from a subcutaneous injectable disease-modifying~     treatment (DMT) given several times a week (Rebif, Betaferon or Copaxone) to once weekly~     Avonex 30 μg given intra-muscularly. Avonex will be applied by the injection device Avonex~     Pen.~   "
113882|NCT02076828|"~     The aim of the present study was to compare the effectiveness of the different oral iron~     preparations in children with IDA.~   "
113883|NCT02076815|"~     The purpose of this study is determine whether Anagrelide Retard is non-inferior to~     anagrelide immediate release form in treatment of essential thrombocythemia.~      Essential thrombocythemia (ET) is a myeloproliferative neoplasm characterised by a sustained~     increase in platelet counts above the normal value (> 450 x 109/L) and increased~     megakaryopoiesis in the bone marrow, without secondary causes of thrombocytosis.~      Anagrelide hydrochloride selectively reduces platelet numbers by inhibiting megakaryocyte~     development and maturation in humans, without affecting other cell lineages.~      Anagrelide Retard is a new, prolonged release (PR) tablet formulation of anagrelide developed~     by AOP Orphan Pharmaceuticals AG. The rationale for developing this new formulation is based~     on the assumption of having a better tolerability while maintaining an efficacy comparable to~     that of the immediate release formulation.~      The effects of Anagrelide Retard and Thromboreductin® will be compared in terms of mean~     platelet count measured by a central laboratory/centralized method at 3 time points during~     the maintenance phase.~   "
113884|NCT02076802|"~     The epidemic data shows that prehypertension is associated with cardiovascular disease, and~     heavy dietary salt intake could improve the developing of hypertension. We detected the risk~     factors of coronary atherosclerosis of prehypertensive patients with different levels of salt~     intake.~      The aim of this multicenter prospective, randomized controlled study is to evaluate regular~     physical exercise and salt diet effects on progression of coronary artery disease in patients~     with prehypertension.~   "
113898|NCT02076620|"~     Prospective, open-label, non randomized, dose escalation study that will be conducted in~     sequential cohorts of patients.~   "
113899|NCT02076607|"~     Evaluate the correlation between the structural changes of fractures of the thoracic and~     lumbar spine burst type with clinical outcome of the treatment.~   "
113885|NCT02076789|"~     This study has been designed to prospectively estimate long term complication rates~     (12-months and 5-years) in patients undergoing Implantable Cardioverter Defibrillator (ICD)~     replacement, with and without a planned transvenous lead addition for replacement or upgrade~     to a device capable of additional therapies; the study also evaluates the predictors of~     complications, the patient's management before and during the replacement procedure in~     clinical practice and the estimated costs related to the use of health care resources.~   "
113886|NCT02076776|"~     The purpose of this study is to gain a better understanding of how different types of~     exercise can help people after a stroke. The investigators want to study if different types~     of exercise will improve the use of arm and hand function after a stroke.~   "
113887|NCT02076763|"~     This is an observational prospective study that will allow evaluating the clinical and~     laboratory parameters evolution of at least eight patients with AIP.~      This study will allow establishing a baseline for the evaluation of the eight patients that~     are planned to be included in a gene therapy clinical trial (AAVPBGD-AIP-001) for the AIP~     treatment using a rAAV5-AAT-cohPBGD expression.~      Patients fulfilling the study inclusion criteria will undergo a clinical and laboratory~     evaluation for a minimum of 6 months (with one inclusion visit, one final visit and at least~     two visits of follow up) up to a maximum of 24 months until their inclusion in the subsequent~     clinical trial.~      A complete evaluation of the clinical (symptoms and quality of life assessment) and~     laboratory (blood and urine) data will be collected.~   "
113888|NCT02076750|"~     The purpose of this study is to determine whether weekly dosing of oral vitamin D3 is~     effective in correcting low vitamin D levels in children and adolescents with inflammatory~     bowel disease (also known as Crohn's disease and ulcerative colitis).~   "
113889|NCT02076737|"~     The purpose of this study is to determine if Model-based iterative reconstruction (MB-IR~     VEOTM) in ultra low-dose abdominal CT as the same accuracy for the diagnosis of acute renal~     colic versus standard CT with adaptative statistical iterative reconstruction (ASIR).~   "
113890|NCT02076724|"~     The purpose of this study is to compare two methods for reinforcement of the abdominal~     donor-site after breast reconstruction with the pedicled TRAM-flap. Reinforcement of the~     abdominal donor-site is performed, after randomization, with either a porcine derived~     biological mesh or a synthetic mesh. The patient and the investigator is blinded.~      The aim is to identify the most optimal method for reinforcement of the abdominal donor-site~     and thereby contribute to fast and complete rehabilitation of women undergoing breast~     reconstruction with the pedicled TRAM-flap after surgical removal of the breast tissue due to~     breast cancer, precursors to breast cancer or an increased risk of developing breast cancer~     and thereby following preventive removal of the breast tissue.~      The patients visit the outpatient clinic 4, 12 and 24 months after operation and abdominal~     wall function, the donor site morbidity, the frequency of postoperative complications, the~     aesthetic appearance of the reconstructed breast and the abdominal wall and costs are~     evaluated.~   "
113891|NCT02076711|"~     Background - Aortic valve stenosis (AS) is the most common heart valve disease among adults~     in the Western world with a prevalence of 3 % in people older than 75 years of age. AS~     usually deteriorates over time leading to heart failure, with high mortality if aortic valve~     replacement (AVR) is not performed. Thus optimal timing of AVR is crucial, but can be~     challenging. Increasing life expectancy in our society will augment the therapeutic and socio~     economic impact of AS disease on our health care system. Therefore, new techniques for~     monitoring asymptomatic AS patients are needed. A potential approach is monitoring of LV~     myocardial efficiency (mechanical work/oxygen consumption). These measures have been~     suggested to be involved in the progression of non-valvular heart failure and closely related~     to prognosis, but never applied in a larger population of patients with AS. At present there~     are no recognized pharmacological treatments of AS. It is known that beta-blocker treatment~     in non-valvular systolic heart failure reduce heart rate, improves LV myocardial efficiency~     and reduces mortality. However, in patients with AS, the effects of beta-blockers are~     unknown.~      Hypotheses - Treatment with the beta-blocker metoprolol succinate in patients with~     asymptomatic moderate to severe AS has beneficial effects on LV myocardial oxidative~     metabolism, myocardial efficiency and contractile function.~      Objectives - To investigate if beta-blocker treatment in patients with moderate to severe,~     asymptomatic AS has beneficial effects on LV myocardial efficiency, contractile function and~     physical performance.~      Design - A randomized double blind placebo controlled intervention trial. 40 patients with~     asymptomatic AS will be randomized to either per oral metoprolol succinate (N = 20) or~     placebo (N= 20) for 22 weeks.~      Primary objective - Changes in myocardial efficiency~      Secondary objectives - Myocardial oxygen consumption, Myocardial perfusion at rest, LV~     myocardial function, LVmass, Aortic valve area and transaortic valve velocities, 6 minute~     walking distance, N-terminal prohormone of brain natriuretic peptide, Quality of life~     (estimated by Minnesota living with heart failure questionnaire), LV wall stress~      Methods - Patients will undergo echocardiography (resting and exercise), [11C]acetate PET and~     cardiac magnetic resonance imaging.~   "
113892|NCT02076698|"~     The main objective of the study is twofold:~        1. Assess the clinical efficacy of DBS on epilepsy according to their number and severity~          at 1 year follow up.~        2. Perform a cost-effectiveness analysis from the perspective of Medicare at 1 and 2 years.~      The study hypothesis is that thalamic DBS (neurostimulation of the anterior nucleus of the~     thalamus) will decrease significantly, the frequency (potentially 50% reduction in severe~     crises) of the most severe seizures, in at least 50% of patients who have drug-resistant~     partial epilepsy; and should also improve significantly the quality of life through a gain of~     independence in activities of daily life, the possible recovery of functional abilities,~     recovery of social or professional activities.~   "
113893|NCT02076685|"~     To improve the treatment outcome in patients with tuberculosis and integrate the~     pharmacogenetics into clinical practice, the information of NAT2 genotyping was used in~     re-challenge protocol for isoniazid (INH) titration in patients with anti-tuberculosis~     medication-induced hepatitis.~   "
113894|NCT02076672|"~     This is a single-arm phase II trial to assess the biological activity (in a sub-cohort using~     a Simon two-stage Phase II design) and toxicity of Artichoke Whole Phytocomplex Concentrate~     (WPC). The objective of the study is to explore the potential for a non-toxic phytocomplex~     extract from the artichoke plant as a chemoprevention agent.~   "
113895|NCT02076659|"~     Phase I, multicenter, open-label, dose escalation study to test the efficacy and safety of~     F8IL10 and methotrexate when given as a combination in rheumatoid arthritis patients.~   "
113896|NCT02076646|"~     A prospective, open-label, multi-center, Phase I/II study of L19IL2 in combination with~     Dacarbazine in patients with metastatic melanoma.~   "
113897|NCT02076633|"~     This Phase II study is an uncontrolled, multicenter, prospective study for patients with~     malignant melanoma of the skin in clinical stage III or stage IV M1a.~      Twenty Patients will be treated with a mixture of L19IL2 and L19TNF once weekly for up to 4~     weeks.~      The dose will be distributed among the lesions via multiple intralesional injections.~      The proportion of patients with complete response at week 12 will be calculated.~   "
113900|NCT02076594|"~     This is a randomized, parallel group, non-blinded phase III trial. Patients with advanced~     (locoregional or metastatic) gastric cancer not previously treated with chemotherapy for this~     stage will be randomized in a 1:1 ratio to receive low-TOX (arm A) or EOX (arm B).~     Randomization will be stratified by performance status (ECOG 0, 1 and 2).~   "
113901|NCT02076581|"~     It is often difficult to quantify and distinguish aspects of abnormal muscle tone due to~     neurological injury. This makes it difficult to evaluate therapies that aim to reduce the~     effects of abnormal muscle tone. This research study will evaluate the feasibility of a~     clinician worn device to capture and quantify features of spasticity and dystonia.~   "
113902|NCT02076568|"~     This study is a multi-center, randomized prospective trial with a 6-month follow up. A newly~     developed treatment and education module will be tested compared to a waiting-list control~     group. The module covers the topic diabetes and partnership. Primary outcome variable is~     diabetes-specific empowerment regarding diabetes and partnership. Secondary outcome variables~     are: diabetes-related distress, health-related quality of life, depressive symptoms,~     self-care behavior, and glycemic control.~   "
113903|NCT02076555|"~     This study is a multi-center, randomized prospective trial with a 6-month follow up. A newly~     developed treatment and education module will be tested compared to a waiting-list control~     group. The module covers the topic diabetes and social issues. Primary outcome variable is~     diabetes-specific empowerment regarding diabetes and social issues. Secondary outcome~     variables are: diabetes-related distress, health-related quality of life, depressive~     symptoms, self-care behavior, and glycemic control.~   "
113904|NCT02076542|"~     This study is a multi-center, randomized prospective trial with a 6-month follow up. A newly~     developed treatment and education module will be tested compared to a waiting-list control~     group. The module covers the topic diabetes and sports. Primary outcome variable is~     diabetes-specific empowerment regarding diabetes and sports. Secondary outcome variables are:~     diabetes-related distress, health-related quality of life, depressive symptoms, self-care~     behavior, and glycemic control.~   "
113905|NCT02076529|"~     This study is designted to know optimal dose of Ramosteron to control for chemotherapy~     induced nasea and vomoting (CINV)based on its pharmacokinetics, pharmacodynamic study and~     clinilcal parameters using Rhodes Index.~   "
113906|NCT02076516|"~     The purpose of this study is to evaluate the safety and effectiveness of the CORACTO®~     (Rapamycin®-Eluting coronary stent delivery system) for the treatment of up to two de novo~     lesions or restenotic post-PTCA (non-stented) lesions located in up to two epicardial native~     coronary arteries (maximum one lesion per vessel) suitable for treatment with stents from 2.5~     to 4.0 mm in diameter < than 15 mm suitable for treatment with a single CORACTO® stent in a~     population of 100 patients.~   "
113907|NCT02076503|"~     Prostate cancer is the most frequent cancer in Norwegian men. For optimal treatment, accurate~     staging of the disease at the time point of diagnosis is important. The objective of this~     study is to evaluate the diagnostic potential of a combined PET/MR examination for risk~     assessment and detection of lymph node metastases. The overall aim of the project is to~     improve the investigators ability to provide individually tailored treatment to prostate~     cancer patients.~      The study will include 32 men with high-risk prostate cancer, who are eligible for radical~     prostatectomy. Informed consent is a requirement for inclusion in the study.~   "
113908|NCT02076490|"~     The overall aim of this randomized controlled study is to investigate the effectiveness of~     mirror therapy supported by telerehabilitation on the intensity, duration and frequency of~     phantom limb pain and daily activities compared to traditional mirror therapy and sensomotor~     exercises without a mirror in patients following lower limb amputation.~   "
113909|NCT02076477|"~     This study evaluates the optimal intervention time of radiotherapy for oligometastatic stage~     iv lung cancer.~   "
113910|NCT02076464|"~     The purpose is to evaluate a technologically-enhanced, guided self-help program to reduce~     eating disorder outcomes in college-age women.~   "
113911|NCT02076451|"~     This will be a Phase 1, open-label study of DS-8273a to assess its safety and tolerability,~     identify the Maximum Tolerated Dose and/or Maximum Administered Dose, and assess its~     properties in subjects with advanced solid tumors or lymphomas.~      Up to 5 US sites are planned for participation in Part 1 (Dose Escalation) and Part 2 (Dose~     Expansion) in subjects with solid tumors or lymphomas.~   "
113912|NCT02076438|"~     The study will evaluate if administration of probiotic Culturelle (Lactobacillus Rhamnosus~     GG) along with antibiotics can help decrease the occurrence of diarrhea caused by antibiotics~     as well as Clostridium difficile Diarrhea.~   "
113913|NCT02076425|"~     Parent Child Interaction Therapy Emotion Development (PCIT-ED) will be conducted with a~     sample of preschoolers who exhibit symptoms of depression compared to a wait list (WL)~     control after which participants will receive the active treatment. PCIT-ED is an expansion~     of PCIT, a well-known, widely used and proven effective treatment for preschool disruptive~     disorders. To address early disturbances of mood and affect, a novel ED module was added~     based on empirical data in emotion development. The ED module targets parent emotion learning~     skills with the goal of training the parent to serve as a more effective emotion teacher and~     coach to the child. The goal of the ED module is to enhance the child's capacity for emotion~     recognition and regulation or emotional competence. In order to test the efficacy of~     PCIT-ED, to estimate accurate effect sizes and to investigate mediators and moderators of~     treatment response participants will complete comprehensive pre-, interval, and~     post-assessments.~      Preschoolers over 3 will be offered the option of enrolling in an add-on~     electroencephalography and magnetic resonance imagery study, to investigate neural changes~     associated with PCIT-ED.~      Compared to those randomized to the WL, preschoolers who undergo PCIT-ED will show~     significantly increased rates of remission, greater reductions in MDD symptoms, and decreases~     in impairment; and will show significantly greater increases in emotional competence measured~     by the ability to accurately identify emotions in themselves and others and the ability to~     effectively regulate intense emotions. Compared to those on the WL, parents who undergo~     PCIT-ED will show significantly greater increases in emotion skill learning and reductions in~     MDD symptoms and parenting stress.~   "
113914|NCT02076412|"~     The purpose of this study is to determine whether fostamatinib is safe and effective in the~     treatment of persistent/chronic Immune Thrombocytopenic Purpura (ITP).~   "
113916|NCT02076386|"~     DOL-ART is a multi-center, prospective, non-interventional study of the use of doluetegravir~     as part of an antiretroviral combination therapy in routine daily practice in Germany. The~     primary study objective is a descriptive characterization of the frequency of therapeutic~     monitoring measures in HIV-infected patients under dolutegravir-containing ART in routine~     daily practice in Germany.~      The study is designed to enroll approximately 400 patients. There are no protocol-mandated~     visits or procedures associated with the study. Each patient is expected to participate for a~     maximum of 3 years or until premature discontinuation (i.e., discontinuation of dolutegravir,~     due to death, withdrawal of consent, lost to follow-up).~   "
113917|NCT02076373|"~     The purpose of this randomized and placebo-controlled EpoRepair trial is to evaluate the~     effect of intravenously administered recombinant human erythropoietin (Epo) as compared to~     placebo in preterm infants with brain damage on neurological development until five years od~     age.~   "
113918|NCT02076360|"~     This is a single-blind, randomized (1:1 allocation), stratified, single-parallel clinical~     trial at one institution evaluating the use of a preoperative patient education video as an~     adjunct to preoperative counseling on patient-centered outcomes.~      The aim of this study is to determine the impact of a preoperative patient educational video~     as an adjunct to the routine preoperative visit on patients' preparedness for surgery,~     perception of time spent with their healthcare team, and ultimately their satisfaction after~     surgery. The aim of this video is not to limit the doctor patient interaction (as all~     patients will still be granted their pre-allotted 30 minute visit with the physician~     regardless of their intervention allocation) but rather to augment the visit with additional~     educational information in an attempt to optimize the visit.~      Objective:~      A. Primary Aim(s):~      • To determine if patients feel more prepared for surgery with addition of preoperative~     patient education video~      B. Secondary Aim(s):~        -  To determine if addition of preoperative patient education video correlates with~          improved patient satisfaction after surgery~        -  To determine if patients' perception of time spent with healthcare team in preparation~          for surgery increases with addition of patient educational video~        -  To determine if actual patient-physician time spent counseling differs between groups~        -  To determine if patient preparedness is correlated with objective surgical outcomes~        -  To determine if patient preparedness is correlated with patient symptom improvement~          scores after surgery~      Hypothesis:~      The addition of a preoperative patient education video enhances patient preparedness for~     surgery, increases perception of the amount of time patients spend with healthcare team, and~     improves patient satisfaction.~   "
113919|NCT02076347|"~     The purpose of this project is to compare two pharmacist-led population management strategies~     designed to increase the rate of appropriate monitoring of vitamin B12 and serum creatinine~     for patients taking metformin.~   "
113920|NCT02076334|"~     To examine the influence of compression garments manufactured with Far-Infrared technology on~     exercise performance during and after repeated eccentric isokinetic muscle actions of the leg~     extensors.~   "
113921|NCT02076321|"~     Non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, are excellent medications~     for providing pain control in children with fractures or those who have surgery to correct~     bony deformity requiring the bone to be cut (osteotomy) and realigned. There is some data to~     suggest that these types of medications can adversely affect bone healing in adult patients~     with broken bones or those having spine fusion surgery. There is little data with regard to~     how these medications effect bone healing in children. With this project, the investigators'~     goal is to determine if NSAIDs delay or otherwise adversely effect bone healing and to~     demonstrate that these medications adequately control pain in children with broken bones or~     those who have had an osteotomy.~   "
113922|NCT02076308|"~     Disability of upper limbs due to neurologic and orthopedic disorder or injuries is commonly~     seen clinically. For example paralysis or paresis of upper limb due to stroke is relatively~     prevalent, and it may result in severe muscle weakness, pain, contracture, spasticity and~     disability. These patients need early and regular rehabilitation to regain their function and~     prevent unnecessary complications such as contracture and disuse atrophy. Proper~     rehabilitation is important but the challenge is also great. However, rehabilitation training~     is a very labor-intensive task in which one to one treatment is essential and that will~     restrict the number of patients served. Moreover, patients receiving home programs are~     difficult to supervise, resulting in reduced training effect and delayed functional recovery.~     In order to reduce related cost (including time, personnel, facilities, and expense, etc.) of~     rehabilitation in hospitals or clinics, this Robot research team had developed a prototype of~     upper-limb exoskeleton rehabilitation robot and its related technology and human-robot~     interaction. This robot is used to serve the rehabilitation need of those patients suffering~     from upper extremities dysfunctions and also can provide careful designed therapeutic program~     of upper limbs including shoulder and elbow joint exercises. Its control software also~     provides a therapeutic management system with intelligence and ergonomic consideration. This~     work was funded by National Taiwan University Hospital (NTUH) since 2008 and has applied for~     both the U.S. and Taiwan (ROC) patents, where the latter has been approved in Nov. 2011. The~     clinical trial was firstly approved by Research Ethics Committee B of NTUH in 2009 and~     finally approved by Department of Health (DOH) in April 2011. This team had completed the~     clinical trial for healthy subjects and pre-clinical trial for stroke patients. Based upon~     this experience an innovative and intelligent SMART Robot Rehabilitation System for Frozen~     Shoulder Syndrome is proposed to prove its safety, efficacy, and cost-effectiveness.~   "
113923|NCT02076295|"~     Mild cognitive impairment and dementia are frequent non-motor complications of moderate to~     advanced Parkinson's disease. Brain positron emission tomography (PET) study findings confirm~     post-mortem evidence that cholinergic loss is related to cognitive impairment in Parkinson's~     disease. However, current cholinergic augmentation therapy is not always effective and it~     should only target those Parkinson's disease patients who have evidence of cholinergic system~     impairment. The objective of this study is to study the association of a particular subtype~     of cholinergic receptors, so-called nicotinic acetylcholine receptors, with cognition in~     Parkinson's disease using a novel PET marker of cholinergic system integrity.~   "
113924|NCT02076282|"~     Radiation therapy uses radiation to treat lung tumors and metastases in the mediastinum. In~     order to irradiate as precise as possible, and in order to evaluate the effect of radiation~     treatment, it is important to depict the lung tumor and the lymph node metastases as accurate~     as possible. Currently, radiation oncologists use PET-CT for this purpose. However, PET-CT~     does have its drawbacks, and partly because of this, large volumes are irradiated in current~     treatment.~      The investigators believe that MRI can be used to improve depiction of the tumor and lymph~     nodes and of their motion. However, there is currently no MRI protocol available which is~     aimed at improving radiotherapy.~      In this study, the investigators want to select the optimal MRI settings for depiction of the~     lung tumor, the lymph node metastases and their movement.~      The investigators plan to do this by first examining 10 healthy volunteers, followed by 20~     patients with non-small cell lung cancer.~   "
113925|NCT02076269|"~     This purpose of this study is to obtain inhalation profiles in subjects with very severe~     Chronic Obstructive Pulmonary Disease (COPD). This is a study with no investigational~     medicinal product. Each subject will attend the clinic on 2 occasions, initially for a~     screening visit and then for further assessments if included (Visit 1). The maximum time that~     a subject may be enrolled in the study is 33 days from the screening visit to follow up.~   "
114916|NCT02063282|"~     The investigators hypothesize that development of symptoms characteristic of Clostridium~     difficile infection will be 2-3 times higher in asymptomatic carriers, compared to that of~     non carriers and expect to find risk factors for development of symptomatic clostridium~     difficile.~   "
113926|NCT02076256|"~     Helping relationships from significant others may assist patients with chronic kidney~     diseases to exercise health behaviors. Patients will adhere on the suggestions from medical~     staff and perform health lifestyle to maintain healthy behavior. The progress of the disease~     may be delayed.~      The research is a 3-year study to explore the influence of helping relationships on healthy~     behaviors among patients with chronic kidney disease. Building on the findings from the past~     three years study and the literature on trans-theoretical Model, helping relationships will~     be articulated. A helping relation intervention will be applied to evaluate its effect on~     healthy lifestyle and quality of life.~      The first year study will be a survey design. An instrument to measure the helping~     relationship will be established and tested. Total of 200 participants will be recruited to~     test the reliability and validity of the instrument. After evaluating the psychometric~     properties of the instrument, items may be revised according to the results. The second year~     of research will be a cross-section study. Of 250 subjects will be recruited to explore the~     correlations between helping relationships, healthy life styles, and quality of life. Data~     will be analyzed using hierarchical linear regression. In the third year, an experimental~     design will be applied to test the effect of a helping relationship intervention. One hundred~     and twenty subjects will be recruited and randomly assigned to the experimental and the~     control group for 60 subjects in each group. The helping relationships intervention program~     will be implemented on the experimental group. And the control group will be provided with~     routine nursing care. Data will be collected at baseline, the sixth and the ninth month of~     the third year of study. Data will be analyzed using generalized estimating equation measures~     to evaluate the effect of the intervention program.~   "
113927|NCT02076243|"~     This is an investigator initiated phase II study to assess the efficacy of a chemotherapy~     called nab-paclitaxel as first line cytotoxic chemotherapy in subjects with unresectable~     locally advanced or metastatic cutaneous squamous cell carcinoma (SCC). All subjects receive~     the treatment by vein weekly and receive the same dose of the treatment.~      The risk of developing cutaneous SCC is approximately 10% in a lifetime. The vast majority~     are treated surgically and do not recur. However a small percentage become unresectable over~     time or metastasize distantly in the body. Unresectable and metastatic cutaneous SCC has a~     poor prognosis and oncologists often choose a whole body therapy without the benefit of~     prospective efficacy data. Very little prospective investigation into the efficacy of~     specific chemotherapy regimens as a function of line of therapy has been performed in this~     patient population. Nab-paclitaxel is type of chemotherapy that has demonstrated activity in~     other types of cancer such as lung and head and neck cancers. The primary objective of this~     study is to determine the response rate (percentage of subjects with tumor shrinkage) to~     nab-paclitaxel treatment in subjects with cutaneous SCC who have not received cytotoxic~     chemotherapy in the unresectable or the metastatic settings.. Secondary objectives are the~     progression free survival (time until tumor starts to grow), safety, assessment of the~     percentage of subjects whose tumor expresses a protein called SPARC, and correlating the~     expression of SPARC with response to treatment. To determine if the tumor expresses SPARC~     part of a prior standard biopsy such as that performed to establish the diagnosis of SCC will~     be used. SPARC is a protein that is overexpressed in a range of different cancer types and~     may alter the environment around the tumor possibly in a way that may make the SCC more~     responsive to treatment with nab-paclitaxel.~   "
113928|NCT02076230|"~     This is an open-label, Phase 1, two-center trial to evaluate the mass balance and metabolite~     profile of carbon 14 [14C]-labeled TH-302 (Label 1 and Label 2) followed by subsequent~     treatment with unlabeled TH-302 in cancer subjects with locally advanced or metastatic solid~     tumors.~   "
113929|NCT02076217|"~     This project will quantify rates of contraceptive failure when unprotected intercourse occurs~     5-14 days prior to initiation of highly effective reversible contraceptives (such as IUD's~     and Implants).~   "
113930|NCT02076204|"~     Adverse birth outcomes result in significant emotional and economic costs for families and~     communities. Research suggests that poor birth outcomes are influenced by a variety of~     social, psychological, behavioral, environmental, and biological factors. Home visiting~     programs represent a promising means of impacting each of these areas.~      The Mother and Infant Home Visiting Program Evaluation - Strong Start (MIHOPE-Strong Start)~     will evaluate the effectiveness of two evidence-based home visiting models at improving birth~     outcomes for women who are enrolled in Medicaid or CHIP. The two models to be studied -~     Healthy Families America (HFA) and Nurse-Family Partnership (NFP) - have both shown some~     evidence of improving birth outcomes in prior research.~      The overall goals of the study are to determine whether home visiting programs improve birth~     outcomes and reduce health care costs in the child's first year. In addition, the evaluation~     is designed to investigate the features of local programs and of home visitation that lead to~     greater effects on birth outcomes and health care costs. The study includes an impact~     analysis to measure what difference home visiting programs make on maternal prenatal health~     and health care use, preterm birth and other birth outcomes, and infant health and health~     care use. It also includes an implementation analysis that will describe the families who~     participate and examine how the program models operate in their local and state contexts. The~     primary data used in the study are expected to be from surveys completed by families and home~     visiting staff, Medicaid and CHIP data, vital records, and program service records. Among~     families who are eligible for the study, random assignment will be used to select families~     for enrollment in home visiting services. Those selected for home visiting services will form~     the program group, and those not selected will form a comparison group. The research team~     will monitor both groups over time to see if differences emerge in the outcome areas~     mentioned above. Although the study will affect which families can enroll in home visiting~     services, no fewer families will be served as a result of the study.~   "
113931|NCT02076191|"~     The purpose of this study is to test the safety and tolerability of ruxolitinib at different~     dose levels in combination with decitabine and the effectiveness of ruxolitinib in~     combination with decitabine in patients with accelerated or blast phase Myeloproliferative~     Neoplasm (MPN), which is a group of diseases of the bone marrow in which excess cells are~     produced. Ruxolitinib is a drug that is approved by the Federal Drug Administration (FDA) for~     the treatment of patients with advanced forms of myelofibrosis. It inhibits the Jak proteins~     that are often abnormal in MPN. A recent clinical study showed that ruxolitinib treatment~     could put some patients with this disease into remission. Decitabine is a chemotherapy,~     approved by the Federal Drug Administration (FDA), that has been used to treat acute~     leukemia. It works in some patients, but most patients with accelerated and blastic MPN do~     not respond to treatment. Ruxolitinib and decitabine will be combined in this study to find~     out what dose of the two medicines are safe together. Using Ruxolitinib in combination with~     Decitabine is experimental. The investigators want to find out what effects, good and/or bad~     it has on the patient and the disease.~   "
113932|NCT02076178|"~     This study is a Phase IIa, randomized, multi-site, two-arm, double-blinded study to evaluate~     the safety, tolerability, and acceptability of GSK1265744 long acting injectable formulation~     (744 LA) in adult male subjects. To evaluate the safety and tolerability of the injectable~     agent, 744 LA (800 milligrams (mg) dose administered at three time points at 12 week~     intervals) through Week 41 in HIV-uninfected men. Eligible participants will be randomized in~     a 5:1 ratio to receive 744 LA or matching placebo. Participants will receive daily oral 744~     (30 mg tablets) or matching placebo for 4 weeks during the Oral Phase of the study, followed~     by a one week washout period. Following safety lab assessments from the Oral Phase,~     participants will enter the Injection Phase and receive Intramuscular (IM) injections of 744~     LA or placebo at three time points at 12 week intervals. IM injections will consist of 800 mg~     of 744 or a matching control~   "
113933|NCT02076165|"~     Women Veterans have high rates of insomnia. Prior research and our preliminary findings show~     that insomnia impacts the health and quality of life of women Veterans and that those with~     insomnia prefer non-medication treatments over sleeping pills. The proposed study will~     compare two non-medication behavioral treatments for insomnia to determine impacts on~     adherence rates and sleep/wake patterns. The results of this study will ultimately improve~     the repertoire of available behavioral treatments for insomnia within VA and improve~     important health and quality of life outcomes among women Veterans who receive VA healthcare.~   "
115008|NCT02062073|"~     Purpose of this study will be to determine the potential of abametapir lotion to induce~     sensitization by repeated topical application to the healthy skin of humans under controlled~     conditions.~   "
113934|NCT02076152|"~     In this research study, the investigators are using FMISO-PET and MRI scans to explore the~     delivery of bevacizumab to the blood vessels in patient's with recurrent glioblastoma before~     and after treatment.~      Bevacizumab is approved by the U.S. Food and Drug Administration for use in patients with~     recurrent glioblastoma . It works by targeting a specific protein called VEGF, which plays a~     role in promoting the growth or spreading of tumor blood vessels. Since anti-VEGF agents also~     affect normal blood vessels in the brain, they can inhibit the way other drugs used in~     combination with bevacizumab are delivered to the tumor.~      In PET scans, a radioactive substance is injected into the body. The scanning machine finds~     the radioactive substance, which tends to go to cancer cells. For the PET scans in this~     research study, the investigators are using an investigational radioactive substance called~     FMISO. Investigational means that the role of FMISO-PET scans is still being studied and~     that research doctors are trying to find out more about it. FMISO goes to areas with low~     oxygenation so parts of the tumor that do not have enough oxygen can be seen.~      In addition, a vascular MRI will be used to evaluate the changes in tumor blood flow, blood~     volume, and how receptive blood vessels are. This scan will be performed at the same time of~     the FMISO-PET scan.~   "
113935|NCT02076139|"~     This is a double-blind, masked, compared with placebo clinical trial in healthy volunteers~     with or without tuberculosis infection. This trial aims to study the effect of the probiotic~     Nyaditum resae® at the level of specific Regulatory T cells (Treg) memory cells one week~     after the first administration and the global tolerability of the treatment. Nyaditum resae®~     is a preparation in the form of drinkable vials containing heat-killed environmental~     mycobacteria. The overall objective of the study is the effect of Nyaditum resae® on~     immunity, which could reduce the risk of developing active tuberculosis.~   "
113936|NCT02076126|"~     The overall objective is to identify quickly after birth the preterm infants who will develop~     respiratory distress syndrome (RDS) for the purpose of treating them as early as possible~     with surfactant, to reduce, and if possible, to avoid sequelae, including long-term oxygen~     treatment.~      We have therefore developed a quick test, which we believe will be ideal for this type of~     diagnostics, and will now test the method in a preclinical trial.~   "
113937|NCT02076113|"~     The purpose of the study is to determine the optimal surgical approach (ventral vs dorsal)~     for patients with multi-level cervical spondylotic myelopathy (CSM). There are no established~     guidelines for the management of patients with CSM, which represents the most common cause of~     spinal cord injury and dysfunction in the US and in the world.~      This study aims to test the hypothesis that ventral surgery is associated with superior Short~     Form-36 physical component Score (SF-36 PCS) outcome at one year follow-up compared to dorsal~     approaches and that both ventral and dorsal surgery improve symptoms of spinal cord~     dysfunction measured using the modified Japanese Orthopedic Association Score (mJOA). A~     secondary hypothesis is that health resource utilization for ventral surgery, dorsal fusion,~     and laminoplasty surgery are different. A third hypothesis is that cervical sagittal balance~     post-operatively is a significant predictor of SF-36 PCS outcome.~   "
113938|NCT02076100|"~     This is a 3-part study of ruzasvir (MK-8408) for participants with hepatitis C infection.~     Successive participants will be enrolled as dose levels are evaluated to find the maximum~     safe and well tolerated dose of ruzasvir. Part I will be for participants with hepatitis C~     virus (HCV) genotype 3 (GT3) and will run first: Part II will be for participants with HCV~     genotype 1a (GT1a), and Part III will be for participants with HCV genotype 2b (GT2b). Parts~     II and III may run concurrently. The primary study hypothesis is that a safe and tolerable~     dose of ruzasvir that reduces viral load will be found to support further clinical~     investigation.~   "
113939|NCT02076087|"~     The overall goal of this proposal is to characterize the immune cell profile of subcutaneous~     abdominal adipose tissue in lean, overweight, obese and lipedema adults, and to evaluate~     potential associations between different adipose tissue immune cell types and metabolic~     profile.~   "
113940|NCT02076074|"~     This phase I/II clinical trial studies the side effects of delivering radiation therapy in a~     single session instead of multiple treatments over several weeks and to see how well it works~     in treating patients with low-risk stage 0-I breast cancer. Partial-breast irradiation, a~     type of radiation therapy focused only to the part of the breast that has cancer in it, given~     at a lower dose than standard whole-breast radiation therapy. Single fraction high-gradient~     partial-breast irradiation may cause fewer side effects, help prevent breast cancer from~     coming back, and improve the appearance of the breast and quality of life of patients with~     breast cancer.~   "
113941|NCT02076061|"~     This is a longitudinal observational study to identify and validate protein biomarkers for~     COPD (chronic obstructive pulmonary diseases) and cardiovascular disease in smokers and~     ex-smokers attending primary care. Special emphasize is to correlate biomarkers to different~     phases of COPD, to progression of the disease, and to treatment of the disease. Furthermore,~     linkage between COPD, cardiovascular disease, and lung cancer will be investigated by~     identifying protein biomarkers.~   "
113942|NCT02076048|"~     The purpose of this study is to take images of the brain in order to see if long-chain~     polyunsaturated fatty acid (LCPUFA) exposure during infancy influences brain structure and~     function in middle childhood.~   "
113943|NCT02076035|"~     It is still unknown the pathogenesis of low back pain and a lot of hypothesis were discussed~     for a long time. Because non-invasive imaging modalities greatly underestimate the prevalence~     of epidural pathogenesis an endoscopic examination of the epidural space has been advocated~     as both a diagnostic and therapeutic modality. It seems that immune-inflammatory factors play~     a more substantial role in pain status. Myeloscopic investigation have shown how~     morphological pictures of the epidural area in patients with chronic low back pain (CLBP) are~     much more complex and heterogeneous than what can be identified with traditional~     investigation suggesting a biochemical involvement. Endoscopy of the epidural space~     (epiduroscopy) is a minimally invasive technique, used to directly visualize pathological~     features inside of the lumbar spinal canal to locate tissues responsible of eliciting pain~     and the presence of any pathological structures within the vertebral channel, such as fibrous~     adherences, inflammatory processes, severe fibrosis and/or stenoses, in order to realize an~     effective therapeutic approach in a lot of different CLBP status as those due to spinal~     stenoses or failed back surgery syndrome. To deepen the molecular causes of interindividual~     variability of epiduroscopy outcomes in terms of decrease of pain, it is useful to analyze~     the DNA variants encoding IL6 and IL1 cytokines and to relate them with gene expression~     levels and with the cytokine dosage. By this technique, it is possible to analyze in the~     biopsy of the epidural tissue the specific expression of the cytokines: there is already~     evidence that inflammatory factors may be involved in the genesis of LBP. At this regards, it~     would be really important to compare systemic cytokine levels before the epiduroscopy with~     those detected immediately post procedure and after one month, to understand if the cytokines~     could play a key role and be a biomarker of the epiduroscopy outcome.~      Concerning DNA polymorphisms, it has been demonstrated, in many disease-state meta-analyses,~     that the IL6 variant rs1800795 affect gene transcription and influences the IL-6 levels.~     Moreover, interleukin 1 (IL-1) is a major factor controlling the inflammatory response. The~     IL-1 gene family includes the IL-1α, IL-1β and the IL-1 receptor antagonist (IL-1Ra) genes~     that mediate immune and inflammatory responses. SNPs in IL-1α, IL-1β and IL1Ra modify bone~     mineral density promoting intervertebral disc disease (IDD). The simultaneous carriage of the~     IL-1bT3954 and the IL-1Ra A1812 alleles significantly enhances the risk of low back pain~     (LBP) occurrence, the number of days with pain, and the number of days with limitations in~     daily activities due to pain.~      A recent study suggested that methylation status of a single CpG site in the IL6 promoter is~     related to IL6 messenger RNA levels and that lower methylation contributes to the risk of~     developing Rheumatoid Arthritis.~      The investigators will try to identify if it there is a correlation with success of the~     epiduroscopy approach in terms of freedom from pain with genic expression and cytokine~     dosage.~      Finally, the investifators will compare the cytokine gene expression and the DNA methylation~     status of IL6 promoter in patients with favorable outcome and in no responders, to study the~     role in gene expression.~      This study is addressed to detect if the genetic variability might be used in near future in~     clinical setting, to predict the success of epiduroscopy.~   "
113944|NCT02076022|"~     We propose a prospective, randomized clinical study to assess the efficacy of minimally~     invasive autologous fat transfer addressing pain and poor prosthetic fit at amputation sites.~   "
113945|NCT02076009|"~     The purpose of this study is to compare the effectiveness of daratumumab when combined with~     lenalidomide and dexamethasone (DRd) to that of lenalidomide and dexamethasone (Rd), in terms~     of progression-free survival in participants with relapsed or refractory multiple myeloma.~   "
113946|NCT02075996|"~     The purpose of this non-interventional study is to collect data on the efficiency and safety~     of pomalidomide in combination with dexamethasone in the routine application~   "
113966|NCT02075723|"~     The purpose of this study is to determine if sleep restriction provokes an increase in risk~     factors for metabolic diseases, such as elevation of ectopic fat and decreased sensitivity to~     insulin. We propose to evaluate the effect of sleep restriction in a model of metabolic~     challenge (overfeeding) caricaturing the conditions of modern societies everyday life .~   "
115009|NCT02062060|"~     Purpose of this study is to evaluate the efficacy of at-home administration of a single~     application of abametapir lotion 0.74% w/w for the treatment of head lice.~   "
113947|NCT02075983|"~     Our research is part of the global effort to develop a vaccine against HIV. We aim to develop~     a non-invasive, needle-free 'transcutaneous' vaccine. It will be a water-based solution which~     is placed on the surface of the skin of the upper arm, after the hairs have been stripped~     away. The active component of the vaccine - DNA which contains genes derived from the virus -~     will enter through the hair follicles from which the hair has been stripped. The DNA will get~     into cells, which will use the HIV genes to make copies of virus proteins. These proteins~     will stimulate the body's immune system and, we hope, make it able to protect against HIV~     infection. The research is to assess the safety of this approach, and how good it is at~     stimulating the immune system. We will combine the 'transcutaneous' vaccine with an~     'intramuscular' version which is injected into the muscle of the thigh, and compare this~     combination with: intramuscular plus 'intradermal' (injection into the skin); and~     intramuscular with added 'electroporation' - use of a pulse of electricity to increase uptake~     of DNA vaccines.~      We will invite healthy men and women to take part in this research. Volunteers will first be~     assessed to ensure they are eligible to participate. A total of 30 will be enrolled and each~     will receive three vaccinations over the course of 12 weeks. We will assess the effects of~     the vaccinations by recording any symptoms experienced by the volunteers, and by analysing~     samples of their blood. The research will take place at the St Mary's Hospital campus of~     Imperial College London, UK. The DNA component of the vaccine is an experimental substance,~     so we will monitor very closely the wellbeing of the men and women who participate in the~     research.~   "
113948|NCT02075970|"~     Neonatal anemia is the most commonly encountered hematologic problem among all neonates cared~     for in the neonatal intensive care unit (NICU). This project seeks to better understand the~     pathophysiology and treatment of this challenging and important condition, especially as it~     affects premature, critically ill very low birth weight (VLBW) infants who require intensive~     laboratory blood monitoring leading to the need for multiple red blood cell (RBC)~     transfusions (RBCTX). In the research strategy proposed in Study 1, Aims 1, 2 and 3,~     recombinant human erythropoietin (Epoetin Alpha, PROCRIT, provided by Janssen Scientific~     Affairs) will first be administered to 1.0 to 1.5 kg VLBW infants; then comprehensive~     pharmacokinetics (PK) and pharmacodynamics (PD) data will be systematically gathered and~     analyzed to identify clinical and laboratory covariate parameters differentiating the infants~     based on their level of Epoetin Alpha responsiveness. Finally the Epoetin Alpha~     responsiveness predictors thus determined will be applied prospectively in the Aim 4 Study, a~     2 x 2 design in which VLBW infants will be identified as good or poor Epoetin Alpha~     responders, based on the predictors, and then randomly assigned to receive Epoetin Alpha~     treatment or no treatment. This will test the central hypothesis: RBCTX can be eliminated in~     the majority of good Epoetin Alpha responders by optimal administration of Epoetin Alpha, but~     only marginal reductions in RBCTx will occur in the poor Epoetin Alpha responders. This~     project challenges the prevailing thinking that the efficacy of Epoetin Alpha dosing in~     stimulating erythropoiesis is insufficient to eliminate the need for RBC transfusions in VLBW~     infants. Based on extensive preclinical and clinical PK/PD studies by our PPG team, we~     contend that previous Erythropoietin treatment studies in VLBW infants were not able to~     realize the full potential of Erythropoietin to eliminate RBCTX (in contrast to the very~     successful use of Erythropoietin in adult renal failure patients) because previous VLBW~     studies were conducted 1) without Epoetin Alpha dosing individualized for the complexities of~     neonatal erythropoiesis and PK/PD of Epoetin Alpha and 2) without consistent criteria for RBC~     transfusion, Epoetin Alpha dosing, and patient enrollment. Net Epoetin Alpha responsiveness~     as reflected in Hb level depends on two components: Epoetin Alpha PD and RBC lifespan (Fig~     15). By determining RBC lifespan, we will explain inter-subject variability of Epoetin Alpha~     responsiveness resulting from one of these components. The fetal lifespan data will be~     examined for its correlation with gestational age. If the correlation is statistically~     significant, gestational age will be included in the final selection of covariates for the~     population PK/PD model to be developed at the end of Infant Study 1. To fully understand the~     correlation of RBC lifespan with gestational age infants ranging from 22-42 weeks gestational~     age will be studied. The overall impact of Project 1 will be significant and potentially~     transformative: the development of a personalized, mechanism-driven approach built on sound~     principles will improve understanding of neonatal anemia and will be applicable to the care~     of premature, anemic infants.~      RELEVANCE Project 1 results confirming our hypothesis that PK/PD optimized Epo treatment is~     effective in eliminating RBC transfusions administered to a select sub-group of NICU infants~     will provide fundamental knowledge about neonatal anemia that will reduce the burden of~     illness and disability caused by this condition. In addition, our results will stimulate~     researchers to extend our findings to other sub-groups with neonatal anemia, ie, smaller and~     sicker infants, and will stimulate novel treatments with similar, new biotechnology-produced~     protein drugs.~   "
113949|NCT02075957|"~     Description of new transcriptional profiles associated with risk of relapse and~     identification of specific sites of relapse in non-small cell lung cancer, toxicity and~     resistance to adjuvant chemotherapy in completely resected non-small cell lung cancer~     (NSCLC).~   "
113950|NCT02075944|"~     The present study will investigate the effects of aerobic exercise on cognition and growth~     factors including brain-derived neurotrophic factor (BDNF) in young adults aged 15-21 years.~     The included subjects will be randomized to three different groups including one control~     group and two exercise groups. Subjects randomized to the exercise groups will complete 30~     minutes of aerobic exercise 3 times a week for 9 weeks incorporating low (group I) or high~     (group II) intensity aerobic exercise. The exercise will be conducted as running or indoor~     cycling (supervised). At baseline and 9-weeks follow-up all subjects will complete two~     cognitive tests (measures of concentration and sustained attention), a maximal cycling test~     (direct measures of VO2max), an intelligence quotient test, anthropometric measures, fasting~     blood samples and blood samples immediately following the cycling test. The blood samples~     will be analyzed for growth factors including BDNF and metabolic factors.~   "
113951|NCT02075931|"~     The investigators have learned that knee replacement patients are not more physically active~     after surgery. This is true even though their pain is less compared to before surgery. This~     low level of physical activity is not healthy. It can increase the chances of weight gain,~     which can create other issues. It can also lessen physical function. Some studies have looked~     at physical activity feedback systems to increase how active people are. Studies have~     investigated face to face patient group meetings for this,too. These systems and meetings can~     increase physical activity. The investigators will study the effects of a physical activity~     monitors with group meetings after knee replacement. The investigators hypothesize that~     physical activity levels and physical function will increase. The investigators goal is to~     help knee replacement patients lead healthier lives and maintain or enhance their physical~     function.~   "
113952|NCT02075918|"~     Purpose: To improve the diagnosis and assessment of severity of acute alcoholic hepatitis~     Participants: Patients admitted to one of ten centers with acute alcoholic hepatitis~     Procedures (methods): Consecutive patients admitted with acute alcoholic hepatitis will be~     enrolled in an NIH U01 study of acute alcoholic hepatitis where liver tissue, blood and stool~     will be collected to discover and validate factors associated with diagnosis, severity of~     disease and survival.~   "
113953|NCT02075905|"~     Subjects enrolled in this study will have biopsies obtained and sent to Dr. Fitzgerald's lab~     for analysis of a validated biomarker panel. Subjects will be stratified to either high or~     low risk of progression to esophageal adenocarcinoma (EAC) based on biomarker panel results.~     Biomarker panel results will not be communicated to sites. Subjects with low grade dysplasia~     will be offered the option of treatment (radiofrequency ablation (RFA)) as part of routine~     care. Subjects with low grade dysplasia who do not want RFA and subjects with no dysplasia~     will receive surveillance endoscopy in 1 year per routine care. All subjects will be~     administered a questionnaire seeking information about hypothetical willingness to be~     randomized to treatment or surveillance.~   "
113954|NCT02075892|"~     Purpose: To determine the acute effects of a mushroom blend vs. placebo on oxygen kinetics,~     aerobic power and time to fatigue in healthy adults.~   "
113955|NCT02075879|"~     The purpose of this study is to examine the effects of a nurse-led case management programme~     on home exercise training for haemodialysis patients. We hypothesised that: a. There is no~     significant difference in physical functioning between participants receiving the nurse-led~     home exercise training programme and those receiving the comparison care. b. There is no~     difference in depression between participants receiving the nurse-led home exercise training~     programme and those receiving the comparison care. c. There is no difference in quality of~     life and health perception between participants receiving the nurse-led home exercise~     training programme and those receiving the comparison care. d. There is no difference in~     physical activity levels between participants receiving the nurse-led home exercise training~     programme and those receiving the comparison care. e. There is no difference in perceived~     benefits and barriers of exercise between participants receiving the nurse-led home exercise~     training programme and those receiving the comparison care.~      The study was a randomized controlled trial conducted in two haemodialysis units of two~     tertiary hospitals in Nanjing, China. Participants were randomly assigned to either study~     group or comparison group. Participants in both groups received the in-center exercise~     training (20 minutes) before haemodialysis sessions weekly for 6 weeks and were instructed to~     perform exercise at home. The in-center training was focused on flexibility and strengthening~     exercise. Patients were encouraged to have cardiovascular exercises at home which will~     improve their cardiovascular conditions and endurance. The list of cardiovascular exercise~     included brisk walking, bicycling, jogging. Participants in the study group were instructed~     to start walking or brisk walking at low duration and gradually progress to a maximum of 30~     minutes daily per week. To facilitate exercise progression, the nurse case managers discussed~     exercise benefits, explored exercise barriers and developed mutual goals with patients. The~     nurse motivated them and checked the exercise behaviors to ensure adherence to the~     recommended exercise regime. The nurse case managers interviewed the study group patients~     weekly for six weeks and biweekly for another six weeks. Participants in the comparison group~     only participated in the in-center exercise training. The comparison group patients received~     usual care from the nurse without the interviews and mutual goals developed.~   "
113956|NCT02075866|"~     Finnish Genetic Study for Arrhythmic Events (FinGesture is a prospective case-control study~     assessing the characteristics and genetic background of consecutive series of autopsy~     verified out-of-hospital victims of SCD vs. survivors of an acute coronary event in a~     specific geographical area in northern Finland.~   "
130195|NCT01863225|"~     This study is designed to characterize the pharmacokinetics of multi-dose RVX000222 and~     atorvastatin and rosuvastatin when either statin is administered in combination with~     RVX000222 in subjects with dyslipidemia.~   "
113957|NCT02075853|"~     The Evans calcaneal lengthening is a common surgical correction used for children with~     spastic cerebral palsy (CP) and painful flat feet. This procedure involves the insertion of a~     trapezoidal bone graft into the calcaneus bone. Both autograft and allografting materials~     have been used for this procedure, but both types of grafting materials have associated~     limitations. Autologous grafting materials, which are harvested from the iliac crest at the~     time of surgery, are associated with high rates of prolonged donor site pain. There is~     limited bone available from the iliac crest. For this reason autologous bone grafts are not~     commonly used for the Evan's procedure. Cadaver allografting materials are variable in their~     mechanical and geometric properties. Recently, xenografting materials have been developed~     that have consistent mechanical properties and are available in a larger size that is formed~     to fit the individual patient intraoperatively. The purpose of this study is to evaluate the~     long term outcomes of the procedure with the different graft options. Another purpose is to~     compare the difference in surgical correction obtained with the cadaver allograft and the~     xenografting materials. This study will also observe and evaluate a wide range of outcome~     variables that encompass multiple levels of patient care, from clinical observation to parent~     and patient satisfaction, and compare these with the observed changes in the radiographic and~     plantar pressure parameters of the foot. This data will be evaluated pre to post surgery and~     for two years of follow-up time. The aim is to uncover the characteristics of collapse~     observed with the two different grafting materials.~   "
113958|NCT02075840|"~     This randomized, active controlled, multicenter phase III open-label study is designed to~     evaluate the efficacy and safety of alectinib compared with crizotinib treatment in~     participants with treatment-naive anaplastic lymphoma kinase-positive (ALK-positive) advanced~     non-small cell lung cancer (NSCLC). Participants will be randomized in a 1:1 ratio to receive~     either alectinib, 600 milligrams (mg) orally twice daily (BID), or crizotinib, 250 mg orally~     BID. Participants will receive treatment until disease progression, unacceptable toxicity,~     consent withdrawal or death. The study is expected to last approximately 42 months.~   "
113959|NCT02075827|"~     Previous studies have shown that subjects who play video games are prone to consume larger~     quantities of food than subjects who are simply resting. This is believed to be due to the~     development of a stress response in the video games group, resulting in increased fuel~     metabolism. However, it was shown that the energy intake of the two groups showed no~     correlation with the subjects' appetite/hunger, which was identical in both groups.~      The investigators propose to explore this issue further by comparing the effects of different~     types of video games on metabolism, using a randomized controlled trial. In this study, they~     will compare the stress levels, heart rate, blood pressure, appetite/mood, energy~     consumption, grip strength, memory and saliva cortisol, leptin and ghrelin levels of subjects~     playing (a) competitive and (b) problem-solving video games. Measurements will be taken~     preceding, during and after the 1 hour intervention. Following the intervention, participants~     will be offered savoury and sweet foods/drinks, which will allow us to assess their appetite~     preferences and caloric intake.~      The investigators first aim is to determine whether there is a significant difference in~     stress levels, eating habits and energy metabolism in the two groups. Our second aim is to~     determine whether there is a difference in glucose distribution to the muscles and brain~     between the two groups.~   "
113960|NCT02075801|"~     -  Assess the effectiveness of sealing localized marginal defects of amalgam restorations~          that were initially scheduled for replacement of restorations.~        -  The hypothesis was that sealed defective margins of the amalgam restorations shows~          similar performance than replacement amalgam restorations.~   "
113961|NCT02075788|"~     The purpose of this study is to investigate how millet incorporation into different baked~     product types influences glycemic response and satiety.~   "
113962|NCT02075775|"~     This project will be a multi-center, prospective longitudinal cohort for all patients~     undergoing primary shoulder instability surgery, excluding isolated SLAP repairs. We will be~     looking for risk factors for recurrent instability, revision surgery, and poor outcomes.~     Patients will be asked to complete the RAND-36, ASES, Shoulder Activity, EQ-5D and WOSI~     outcome measures, as well as demographic and socioeconomic information. Surgeons will~     complete a form after surgery with information on radiographic findings, physical exam,~     surgical findings, and the repair. Patients will wear a sling post-operatively, and follow~     standardized rehabilitation protocols, including physical therapy.~      Patients will be sent outcome questionnaires at 2, 6, 10, and 20 years after surgery.~   "
113963|NCT02075762|"~     The objective of this study is to compare the sample size, architectural preservation and~     diagnostic yield of bronchoscopic cryo-probe transbronchial lung biopsy (C-TBBx) in~     comparison to bronchoscopic standard transbronchial lung biopsy (S-TBBx) and Video-Assisted~     Thoracoscopic Surgery (VATS) lung biopsy for the diagnosis of interstitial lung disease~     (ILD).~   "
113964|NCT02075749|"~     Abstract:~      Background: Complementary and alternative medicine (CAM) had proven efficacy in pain relief,~     correction of nutritional status and improving the performance status. However, lack of~     standardization is the major obstacle for any scientific evaluation of any CAM trial.~     Mucositis is a major complication of irradiation in head and neck (H&N) tumors, the addition~     of chemotherapy to irradiation may enhance this dose limiting problem. Licorice is a strong~     demulcent that had been effectively used in treatment of peptic ulcer. The main purpose of~     this study was to compare the therapeutic safety and efficacy of T. and L. mucoadhesive films~     on oral mucositis in terms of pain control and/or ulcer treatment.~      Methods and Materials: the study was a double-blind, randomized prospective trial of two~     types of mucoadhesive films in the management of oral mucositis occurred during head and neck~     cancer ( HNC ) radiotherapy. oral mucositis was assessed using a quantitative scale (WHO~     scales) and symptoms were assessed using visual analogue scales (VAS). 60 patients were~     enrolled in the study; there were 30 patients in the Triamcinolone (T) and 30 in the Licorice~     (L) group. In the T- group, patients received triamcinolone acetonide mucoadhesive films~     containing 1mg of the drug and patients in the L- group received licorice mucoadhesive films,~     an herbal agent. Data were collected at baseline, then twice a week for 4 weeks.~   "
113965|NCT02075736|"~     The purpose of this study is to compare safety and efficacy of Green Light PVP~     (Photoselective Vaporization of the Prostate) compared to TUR-P in high risk patients~   "
113967|NCT02075710|"~     The purpose of this study is to find out how the amount of fat or sugar in a person's diet,~     or the number of meals eaten each day, affect the amount of fat that people's bodies make,~     the types of fats in the bloodstream, and how much fat is stored in the liver. The study is~     funded by the National Institutes of Health.~   "
113968|NCT02075697|"~     The purpose of Biobadaderm is a to study the safety of systemic therapy in psoriasis.~   "
113969|NCT02075684|"~     The purpose of this research study is to create a prospectively maintained, multicenter~     database of patients undergoing renal biopsy for renal masses performed percutaneously~     (through skin), via an 18 gauge biopsy needle (.048 inches). In this database, the~     investigators will collect and maintain the data from the biopsy procedure. This will allow~     us to evaluate our experience with this procedure as well as to participate in~     multi-institutional collaborative studies in the future. At University of California Irvine,~     the investigators routinely biopsy patients with renal masses under real-time ultrasound~     control. Percutaneous renal biopsy under ultrasound guidance is a routine procedure performed~     to diagnose renal mass histopathology. The safety and efficacy of this procedure has been~     well documented in the literature. The indications for percutaneous renal biopsy have~     expanded as there has been a substantial increase in the number of renal masses that are~     being diagnosed, and the acceptance of percutaneous biopsy continues to expand in parallel.~     The biopsy procedure is part of your normal standard of care and if not being done for this~     research project.~   "
113970|NCT02075671|"~     Rosacea is a chronic inflammatory disorder that is characterized by severe flushing~     (transient erythema), non-transient erythema, papules, pustules, and telangiectasia. Topical~     therapy is not always effective in treating symptoms of rosacea. Furthermore, rapid~     recurrence is common following the use of systemic antibiotics, resulting in the chronic use~     of these medications to control the disease. Although the exact pathogenesis of rosacea is~     unknown, treatment for this condition has been investigated based on its similarity to acne~     and photodamaged skin. Case reports have shown promising results in rosacea patients treated~     with methyl aminolevulinate photodynamic therapy (MAL - PDT). Other than a case report which~     observed significant improvement of papules, pustules, erythema, and flushing following 5 -~     aminolevulinic acid photodynamic therapy (ALA-PDT) treatment of a patient with rosacea, the~     role of ALA-PDT in the treatment of rosacea has not been reported.~      We have designed a pilot study investigating the efficacy of ALA-PDT in treating~     papulopustular rosacea. The objectives of the study are as follows:~      Primary objective:~        1. To evaluate improvement of the inflammatory lesions (papules, pustules, nodules),~          erythema, and telangiectasia of rosacea as assessed by the Investigator's Global~          Assessment (IGA).~        2. To evaluate improvement of the inflammatory lesions (papules, pustules, nodules) of~          rosacea as assessed by the Inflammatory Lesion Investigator's Global Assessment (ILIGA).~           Secondary objectives:~        3. To evaluate improvement of rosacea associated erythema as assessed by the Clinical~          Erythema Assessment (CEA) scale.~        4. To evaluate improvement of the inflammatory lesions (papules, pustules, nodules) of~          rosacea as measured by a difference in inflammatory lesion count.~        5. To evaluate improvement of rosacea as assessed by the Patient Overall Assessment Scale.~   "
113971|NCT02075658|"~     Renal cancer has traditionally been treated by surgical removal of the tumor, as the tumors~     are resistant to chemotherapy and radiation. The traditional treatment, where the entire~     kidney and tumor were removed through an abdominal incision, may now have more long term~     problems than the actual cancer. As a result, less invasive techniques have been developed~     such as laparoscopic surgery where the abdomen is inflated with carbon dioxide (i.e. via an~     insufflation system) and the surgery performed with special instruments through small ports,~     known as trocars. Rapid advances in minimally invasive surgical techniques demand ongoing~     technological improvement.~      Conventional insufflators and trocars allow for laparoscopic surgery to occur, however the~     system does not account for pressure changes within the abdomen when instruments are inserted~     or removed. The AirSeal® System consisting of an insufflation, filtration, and recirculation~     system (AirSeal® IFS), a triple lumen filtered tube set, and a valve free trocar (AirSeal®~     Access Port) has been designed to create and maintain the pressure barrier throughout the~     procedure. The objective of this study is to collect comparative physiological, pulmonary~     compliance and surgical utility data for both the AirSeal® System and conventional~     insufflators and trocars in a controlled population undergoing laparoscopic/robotic renal or~     peri-renal procedures. Subjects enrolled in this study will have their procedure performed~     using either the AirSeal® System or a conventional insufflator and trocars. Both systems have~     been cleared for use by the FDA's 510(k) process and are currently employed in clinical~     practice, including at University of California, Irvine Medical Center. We hypothesize that~     with the use of the AirSeal® System, laparoscopic efficiencies and outcomes will be~     significantly greater than with the conventional insufflator and trocars system.~   "
113972|NCT02075645|"~     A multi-centre prospective cohort study, which examines the effect of a team training~     educational intervention for pediatric resuscitation team members. The study uses~     simulation-based training as the primary teaching method to evaluate the effect of team~     training on team performance, as measured by adherence to PALS guidelines. By re-testing~     participants again after 6-12 months, the study will examine long-term retention of these~     skills. Hypothesis: adherence to PALS guidelines is improved following team training of~     pediatric resuscitation team members.~   "
113973|NCT02075632|"~     This is a multi-center, open-label study to evaluate whether participants follow the duration~     of use instructions for short-term use of alclometasone dipropionate in a population of~     participants with itchy skin conditions who would use OTC treatments for relief. The study~     population will be composed of two different cohorts: chronic condition sufferers (eczema or~     psoriasis) and participants who suffer from occasional itchy skin experiences (such as poison~     ivy, oak, sumac, insect bites, or skin irritations due to jewelry, cosmetics, detergents, or~     soaps) where an anti-itch medication would be used.~   "
113974|NCT02075619|"~     This is an open-label, single-centre, randomized, single dose, three-way crossover, six~     sequence study to evaluate the comparative bioavailability of two Fixed Dose Combination~     (FDC) tablet formulations of amlodipine and rosuvastatin relative to innovator samples under~     fasting conditions, in healthy adult subjects. Subjects will be 12 Chinese and 12 Caucasian~     subjects living in Singapore. The randomisation will be stratified by ethnicity to ensure an~     equal number of subjects will be assigned to each dosing sequence. Subjects will receive each~     of the following three treatments administered in a randomized three-way crossover design: a~     reference treatment consisting of a single 10mg amlodipine tablet and 20mg rosuvastatin~     tablet ; a single fixed dose combination tablet consisting of 10mg amlodipine and 20mg~     rosuvastatin (Test Formulation - FDC 1); and another single fixed dose combination tablet~     consisting of 10mg amlodipine and 20mg rosuvastatin (Test Formulation - FDC 2). Two test~     formulations have same active pharmaceutical ingredients (amlodipine and rosuvastatin), same~     doses and different inactive ingredients. Each subject will participate in three treatment~     periods. The study consists of a screening phase, three treatment periods and a follow-up~     visit. The three treatment periods will be separated by a washout period of 12-17 days.~   "
114043|NCT02074722|"~     Mind-Body Awareness Training (MBAT), in the forms of various yoga and meditative practices,~     has become increasingly prevalent due to an increase in awareness of the potential health~     benefits, and improvements in concentration that this training can provide to practitioners.~     In the present study, we investigate the role of Mind-Body Awareness Training (MBAT) in the~     initial learning of a sensorimotor (SMR) based Brain-Computer Interface (BCI).~      The PI's hypothesis is that MBAT will improve performance in SMR based BCI.~   "
113975|NCT02075606|"~     Circulating tumour cells (CTCs) are detectable in the blood in around 50% of patients with~     functioning NeuroEndocrine Tumours (NET) arising in the midgut area (tumours which are~     secreting hormones and are located in the area in the middle of the digestive system) and~     their presence usually means that the prognosis for the patient is poor. CTCs have also been~     shown to be valuable as predictive markers following treatment and there is increasing~     interest in using CTCs as 'liquid biopsies' that can help to inform treatment decisions. CTC~     analysis has the benefit of being relatively non- invasive and quick compared with a~     conventional CT scan and is therefore an attractive method of monitoring the tumour~     throughout the treatment period.~      The purpose of this study is to assess the clinical value that enumeration will have in~     predicting the clinical symptomatic response and progression free survival in patients~     receiving Somatuline Autogel for functioning midgut NETs over a one year period.~   "
113976|NCT02075593|"~     In this study, the dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) fixed dose combination~     (FDC) tablet is being made available to women who become pregnant while participating in~     study ING117172. Continuation of antiretroviral therapy (ART) is key to both mother and the~     unborn fetus in order to maintain virologic suppression in the mother (thereby decreasing the~     risk for maternal disease progression), but also to reduce the risk of maternal-fetal~     transmission of human immunodeficiency virus type 1 (HIV-1) to her unborn child. This study~     also offers the first opportunity to investigate the impact of pregnancy on DTG~     pharmacokinetics (PK). This is an open-label, single arm interventional study. The number of~     women that will be enrolled into this study cannot be established a priori, as unintended~     pregnancies cannot be determined in advance. The maximum number of women would include all of~     those women randomized to DTG/ABC/3TC FDC (approximately 237), though unintended pregnancies~     in all of these women would not be anticipated.~   "
113977|NCT02075580|"~     Our hypothesis is that totally Implantable Venous Access Devices in neoplastic patients~     modify body image and self-representation. Therefore, the purpose of this study is to~     evaluate the efficacy of psychological intervention on patients undergone this surgical~     practice.~   "
113978|NCT02075567|"~     Background: During and after exercise there is a twofold stimulation of glucose transporter~     type 4 in type 1 diabetes mellitus (T1DM) caused by an exogenous insulin injection and muscle~     contraction. In case of no insulin reduction before exercise and/or an additional~     carbohydrate supplement patients with T1DM would become hypoglycemic. There are no specific~     data dependent on individual exercise intensities and strategies of bolus insulin reduction.~     The aim of the present study is to avoid hypoglycemia during and after exercise and to~     calculate a critical time where blood glucose would decrease to 50% of baseline by a pre~     exercise standardized insulin regimen during standardized cycle ergometer exercises dependent~     on different modes, intensities and energy expenditures as well as counter regulatory~     hormones.~      Methods/design: Participants consist of 7 male subjects aged 18 to 35 years with T1DM~     (fasting C-peptide (≤ 0.3 nmol/l), HbA1c ≤ 64 mmol/mol). After a four-weeks basal insulin~     adaptation of ultralong-acting basal insulin (Novo Nordisk) each subject will perform a~     maximal incremental cycle ergometer exercise test with a reduction of short time insulin of~     40% to determine the individual aerobic/anaerobic threshold called first/second lactate turn~     point (LTP1, LTP2). Four constant load and three high intensity intermittent cycle ergometer~     exercise tests (30min) will be performed at 5% Pmax below and above LTP1 and LTP2 (at 5%~     above LTP2 no high intensity intermittent cycle ergometer exercise test) with a reduction of~     short time insulin doses (standardized breakfast-four hours before each test) of 25% at 5%~     Pmax below LTP1 and 50% at 5% Pmax above LTP1 and 75% at 5% Pmax below and above LTP2 with~     one week interception between testing. 24h before testing subjects will be fitted with a~     continuous glucose monitoring system for at least 48h. Primary outcomes include blood glucose~     decrease from baseline during constant load tests, energy expenditure during testing, 24h~     CGMS measurements and hormones catecholamines, cortisol, glucagon and insulin growth factor~     1. Secondary outcome measurements include heart rate, lactate and respiratory gas exchange~     values.~      Discussion: If the results confirm the hypothesis, this study could be one of the first~     recommendations for T1DM patients, how to adapt bolus insulin dose individually before~     defined exercises without the risk hypoglycemia during and after exercise.~   "
113979|NCT02075554|"~     The primary objective of this study is to evaluate the safety and efficacy of CALIBER~     expandable spacer for the treatment of degenerative disc disease. Radiographic outcomes,~     intra-operative parameters, clinical outcomes, and patient satisfaction will be obtained from~     patients in this 2 year follow-up clinical study.~   "
113980|NCT02075541|"~     The purpose of this Phase II study is to assess the safety, reactogenicity and immunogenicity~     of the investigational Non-typeable Haemophilus influenzae (NTHi) vaccine in patients with~     moderate and severe persistent airflow obstruction.~   "
113981|NCT02075528|"~     Paliperidone ER is a new psychotropic medication for schizophrenia treatment. The studies of~     6-week acute treatment and 52-week maintenance treatment showed positive results in patients~     with schizophrenia and its clinical improvement may start at Day 4. Some second-generation~     antipsychotics have been found that using the first 2 weeks' treatment results to predict the~     fourth or sixth week's treatment response is acceptable.~      The primary aim of this study is to investigate:~        1. . whether the early prediction model used in other atypicals could also be applied in~          paliperidone ER.~        2. . The changes of metabolic parameters and pharmacokinetics after paliperidone ER~          treatment in this study~   "
113982|NCT02075515|"~     The purpose of this study is to demonstrate lot-to-lot consistency in terms of~     immunogenicity, and evaluate safety of the Herpes Zoster subunit (HZ/su) vaccine. The study~     is designed as a randomized, double-blind study with three parallel groups.~   "
113983|NCT02075502|"~     The primary aim of the study is to determine the effect of a community-based walking exercise~     program with detailed training, monitoring, and coaching (TMC) exercise components enhanced~     by community-based participatory research (CBPR) practices (TMC+) on the primary outcome of~     peak walking time (PWT) in patients with peripheral artery disease (PAD).~   "
114004|NCT02075229|"~     Purpose: The purpose of this study is 1) to evaluate the safety and efficacy of currently~     available multichannel cochlear implant systems for newly implanted adults with an indication~     based on open-set sentence recognition that expand criteria currently used by Center for~     Medicare & Medicaid Services (CMS), and 2) to assess the correlation between measures of~     speech recognition in candidates for cochlear implants and their utility in predicting~     audiologic and quality of life outcomes after implantation.~      Participants: Adults (≥ 65 years of age) and CMS-eligible as a primary source of medical~     insurance coverage.~      Procedures (methods): Evaluate objective and subjective outcomes of cochlear implantation in~     a patient population that does not meet current CMS candidacy criteria.~   "
114044|NCT02074709|"~     In this randomized, controlled, observer-blinded study we plan to evaluate pain relief after~     ultrasound-guided transversus abdominis plane (TAP) block using bupivacaine and wound~     infiltration using liposomal bupivacaine in patients undergoing abdominal hysterectomy.~   "
113984|NCT02075489|"~     This study will provide symptomatic veterans with acupressure treatment and determine its~     effectiveness in fatigue relief and pain management for Gulf War Illness (GWI). Investigators~     plan to recruit patients reporting symptoms of GWI through the Department of Veterans Affairs~     (VA), and randomize them into acupressure group (to receive acupressure treatment) and~     control group (to receive Reiki treatment). The acupressure treatment, twice per week for 6~     weeks, will be offered by a licensed acupressure practitioner. Evaluations will be made~     before and after treatment (at 6 weeks). Clinical outcomes will be compared between groups~     (acupressure group vs. control group) and between different timepoints (before treatment vs.~     after treatment) within the same group.~      The results of this study may provide useful information to develop more effective treatment~     for veterans with GWI disease. Since acupressure treatment is of Asian origin and has shown~     excellent promise within its Eastern traditions, if successful, this study has the potential~     to produce a paradigm shift in clinical practice to more effectively relieve the symptoms of~     veterans with GWI disease. Meanwhile, as a non-invasive therapeutic massage, acupressure may~     lend to better patient acceptance and ultimately, greater clinical accessibility.~      Hypotheses~        1. Acupressure besides routine clinical care will produce a more complete fatigue relief~          and pain alleviation in veterans with GWI versus routine clinical care plus reiki~          treatment.~        2. EEG measures will exhibit a positive change when fatigue is relieved and pain is~          alleviated for symptomatic veterans after effective treatment.~   "
113985|NCT02075476|"~     The purpose of this study is to evaluate the effectiveness and safety of two surgical~     techniques for the treatments of proximal extremity humeral fractures and fractures luxation~     in three o four fragments of Neer's classification.~   "
113986|NCT02075463|"~     The study will evaluate the ability of GSK1278863 to increase the hemoglobin (Hgb)~     concentration, or maintain it within the target range, and the safety and efficacy of~     GSK1278863 over 16 weeks of treatment, in hemodialysis-dependent subjects with anemia~     associated with chronic kidney disease who are chronically hyporesponsive to rhEPO. The data~     generated will inform dose requirements for any chronic rhEPO hyporesponsive~     hemodialysis-dependent subjects included in future clinical trials. The study consists of a~     4-week rhEPO run-in period, a 16-week GSK1278863 treatment period and a 4-week Follow-up~     period.~   "
113987|NCT02075450|"~     Our project aims to improve the delivery and assessment of cardiopulmonary resuscitation~     (CPR) during pediatric cardiac arrest by introducing 2 novel approaches: 1. We will evaluate~     the effectiveness of a novel, credit card sized, and highly affordable nano-card CPR visual~     feedback device to improve compliance with HSFC CPR guidelines when used during simulated~     pediatric cardiac arrest; 2. We will also develop and study a novel, Just-in-Time (JIT) CPR~     training video, integrating proven educational methods (video-based lecture, expert modeling,~     practice-while-watching), and use the CPR visual feedback device to provide real-time~     coaching.~      We hypothesize that:~      H1: The use of a CPR visual feedback device will improve compliance with current HSFC CPR and~     resuscitation guidelines during a simulated pediatric in-hospital cardiac arrest scenario~     compared with standard CPR with no visual feedback.~      H2: A JIT CPR Training Video, viewed by healthcare providers 2-4 weeks prior to the~     resuscitation event, will improve compliance with current HSFC CPR and resuscitation~     guidelines during simulated pediatric cardiac arrest compared with those healthcare providers~     with no prior exposure to the JIT CPR Training Video.~      H3: That there is poor correlation between providers' perception of CPR quality and actual~     measured CPR quality H4: That task load varies depending on provider role and type of~     clinical scenario~   "
113988|NCT02075437|"~     This study will provide tools to develop and pilot an intervention for Functional Abdominal~     Pain (FAP) using a ten session intervention with children ages 5-8. Investigators will train~     the subjects to be Feeling and Body Investigators. During treatment phases the following~     will occur 1) gather clues (learn), 2) investigate (experience: perform interoceptive mystery~     missions to explore a body sensation), 3) organize body clues (contextualize: recall other~     contexts that evoke similar sensations), and 4) go on increasingly daring missions~     (challenge: decrease avoidance and safety behaviors). The FBI intervention will be developed~     and refined in 26 child-caregiver dyads during the current R21 phase. In the R33 phase~     investigators will randomize 100 subjects with FAP to FBI or an active control group in order~     to conduct a pilot-test of the feasibility, acceptance, and clinical significance of FBI.~     Young children with FAP who complete the FBI early intervention will learn to experience~     changes in the viscera as fun and fascinating, rather than scary, and will develop new~     capacities for pain management, adaptive functioning, and emotion regulation. For the R21~     Phase (assessing initial feasibility) investigators hypothesize that ≥ 80% of participants~     enrolled in FBI will complete treatment and that ≥ 80% of participants will complete~     home-based practice assignments.~   "
113989|NCT02075424|"~     The purpose of this study is to describe biological stress (cortisolemia) and perceived~     stress in Emergency Call Center Operators and Doctors while processing a center 15 call.~   "
113990|NCT02075411|"~     Anterior cruciate ligament repair using hamstring autograft in children is a painful~     orthopedic procedure. The current practice to provide analgesia for this procedure include~     femoral continuous perineural infusion and femoral single shot peripheral nerve block, along~     with perioperative opioids and NSAIDS both IV and orally. Since the use of opioids can be~     associated with adverse side effects, which include, but are not limited to nausea, vomiting,~     constipation, pruritus and respiratory depression, comparing the amount of opioid used with~     either analgesia delivery method is needed.~   "
113991|NCT02075398|"~     To validate the Respiration Rate Version 2.0 algorithm, housed in the Nellcor Bedside~     Respiratory Patient Monitoring System, for performance during motion conditions.~   "
113992|NCT02075385|"~     General Objective: To evaluate the swallowing results of speech pathologist rehabilitation of~     advanced oropharynges, larynx and hypopharynx cancer patients during neoadjuvant chemotherapy~     and radiotherapy concomitant to chemotherapy.~      Methods and Casuistic: Randomized clinical trial phase II. 80 patients with advanced~     oropharynges, larynx and hypopharynx cancer diagnoses from Barretos Cancer Hospital, which~     had the proposal of neoadjuvant chemotherapy followed by radiotherapy combined with~     chemotherapy. Patients are randomized on two groups: control group and speech pathology~     therapy group~   "
113993|NCT02075372|"~     The successful re-opening of a blocked coronary artery has a beneficial effect on the further~     clinical course (e.g. improvement of clinical symptoms, improved quality of life, increased~     heart function, etc.). However, some types of blockages are more difficult to open by means~     of percutaneous coronary intervention (PCI), a procedure which is commonly used for these~     kind of problems. This procedure makes use of a technique in which special wires, balloons,~     stents (metal or polymeric tube-like structures) and devices are utilized to re-open or~     revascularize a blockage in one of the blood vessels of the heart. This type of blockages are~     chronic total occlusions (CTO). CTOs have certain characteristics which impede the~     revascularization of the blood vessel.~      Nevertheless, remarkable progress has been achieved over the past few years in the area of~     CTO revascularization or CTO PCI. A large range of CTO dedicated materials, such as~     guidewires, guiding catheters, devices, balloons and stents, as well as different techniques~     have been developed. However, at present, reluctance to open CTOs still exists, due to the~     indications and outcomes of percutaneous revascularization as well as the technical~     difficulties which commonly arise during these interventional procedures. The presence of~     these difficulties results in suboptimal success rates worldwide (±70-80%), despite these~     many innovations.~      To increase these success rates and to make sure more interventional cardiologists will treat~     CTOs, a hybrid treatment algorithm has been developed with the materials (e.g. CrossBoss™~     catheter; Bridgepoint Medical, Inc.) and techniques, currently already available. The main~     purpose of this study is to evaluate the efficacy and efficiency of this hybrid algorithm as~     well as validating the efficacy of one of the materials (CrossBoss™ catheter), used in this~     algorithm. To be able to do this, data concerning the patients' demographics, CTO~     characteristics, procedure and outcome will be collected in the form of a registry. This~     registry will be performed in several European centra (Belgium, the Netherlands, United~     Kingdom, France). Since the study will only collect data and no intervention is performed,~     this will be an observational study. At regular time points, the data will be checked for~     errors or inconsistencies. To do this, site visits will be performed at pre-defined times.~   "
113994|NCT02075359|"~     The purpose of this study is to calibrate the Actigraph, Respironics and CamNtech monitors,~     in a wide range of children using energy expenditure measured by respiration calorimetry.~     Energy expenditure will be predicted from the combination of heart rate and activity measured~     by accelerometry. Prediction equations for energy expenditure will be tested and validated~     against a stable isotope method called doubly labeled water for the measurement of~     free-living total energy expenditure.~   "
113995|NCT02075346|"~     Use of an investigational oximetry system to evaluate the triggering of the sensor off~     status with the marketed off-the-shelf sensors.~   "
113996|NCT02075333|"~     The purpose of this study is to examine the effects of ingesting or mouth rinsing a sucrose~     (carbohydrate) versus a sucralose (carbohydrate-free) drink on self control, cognitive~     performance, and blood glucose level.~   "
113997|NCT02075320|"~     Purpose: The proposed research, if successfully implemented, will result in a low-dose,~     low-cost, and highly effective method for screening of lung cancer, leading to reduction of~     the lung cancer mortality rate. Using the stationary Digital Chest Tomosynthesis (s-DCT)~     system the imaging dose for a full tomosynthesis scan is expected to be only 10% of that from~     a low-dose computed tomography (CT). The targeted imaging time of 2s is 1/5 to 1/3 of that~     from a current commercial digital chest tomosynthesis (DCT) system at the same imaging dose.~     Beyond lung cancer screening, the low-dose and sensitive 3D lung imaging modality will likely~     to find applications in areas such as monitoring of pediatric cystic fibrosis patients where~     reduction of imaging dose is critical.~      Participants: One hundred (100) patients undergoing a clinical non-contrast CT for their lung~     nodules will be asked to have this procedure (scan) within 2 weeks (+/- 1 week) of their~     clinical CT and chest radiograph, with no intervening procedures or therapies.~      Procedures (methods): The purpose and endpoint of this study is to compare the sensitivity of~     the s-DCT system to the conventional chest radiographs with non-contrast chest CT as the~     reference standard. One hundred (100) patients undergoing a clinical non-contrast CT for~     their lung nodules will be asked to have this procedure (scan) within 2 weeks (+/- 1 week) of~     their clinical CT and chest radiograph, with no intervening procedures or therapies.~   "
113998|NCT02075307|"~     Obesity usually brings with it disturbances in the body that increase the chances of~     developing serious diseases like diabetes and cancer. These disturbances include one or more~     symptoms of a condition called metabolic syndrome that often leads to diabetes. High levels~     of damage to the DNA that makes up our chromosomes have also been observed in obese people.~     It is possible that these two disturbances are connected. The goal of this project is to test~     this whether consumption of blueberries will improve these abnormalities.~   "
113999|NCT02075294|"~     It is estimated that 350-400 million people have chronic infection with hepatitis B virus~     (HBV) all over the world. In china, 93 million individuals suffer from this chronic~     condition. Currently, seven medications are approved for the treatment of hepatitis B: two~     formulations of interferon and four nucleos(t)ide analogues. The Chinese population has one~     of the longer average life spans, and the size of the aged population has been increasing~     rapidly. As a result, the prevalence of elderly patients with HBV has increased, and the~     potential for development of cirrhosis or hepatocellular carcinoma in such patients is real.~     Hence, treatment of elderly patients with HBV is an important issue. However, ADV or ETV has~     become first choice due to the more side effect of INF and the resistant of LAM and LdT. But~     treatment outcomes with ADV and ETV in elderly are not known yet. In this study, we will~     evaluate and compare the efficacy and tolerability of ADV and ETV between younger and older~     patients with HBV. The aims of the present study are (1)to assess the benefits of ADV or ETV~     therapy for elderly patients with chronic hepatitis B, and (2)to determine differences in the~     emergence rate of side effect.~   "
114000|NCT02075281|"~     The purpose of this study is to determine the optimal dose and regimen of HM11260C, in~     combination with a hypocaloric diet, to reduce weight in obese subjects who are otherwise~     considered in stable health.~   "
114001|NCT02075268|"~     An open label, parallel study to characterize the pharmacokinetics and pharmacodynamics of~     Prasugrel 30 mg or 60 mg in healthy male adult subjects~   "
114002|NCT02075255|"~     The purpose of this trial is to confirm if benralizumab can reduce the use of maintenance OCS~     in systemic corticosteroid dependent patients with severe refractory asthma with elevated~     eosinophils.~   "
114003|NCT02075242|"~     Study to Compare the Safety and Efficacy of Tacrolimus and Steroids in Combination With~     Mycophenolate Mofetil or Without Mycophenolate Mofetil in Liver Transplantation with~     Hepatitis B Virus(HBsAg) Positive~   "
114030|NCT02074891|"~     A health services implementation pilot study, conducted with an observational cohort of~     HIV-uninfected persons including men who have sex with men, heterosexual women and men, and~     injection drug users receiving daily oral antiretroviral preexposure prophylaxis (PrEP) at~     four federally qualified health centers that provide sexual health and primary care services~     to communities with high HIV incidence/prevalence.~   "
114005|NCT02075216|"~     Muscle precursor cells constantly regenerate striated muscles, and include the quiescent~     satellite cells located beneath the basal lamina of skeletal myofibers, which are responsible~     for repair of the terminally differentiated striated muscle tissue. Transurethral~     implantation of autologous myoblasts may represent an improved alternative to synthetic~     bulking agents, with the unique ability to compensate for the deficient muscle fibers in the~     urethral sphincter. Clinical studies of cell therapy based treatment of sphincter~     insufficiency, using muscle derived stem cell transplantation was carried out in patients~     with stress incontinence revealed and confirmed the ability of cell therapy to improve the~     structure and contractile function of the sphincter. In this study autologous heterotopic~     myoblasts will be transurethrally injected in patients with bladder extrophy epispadias~     complex who remained incontinent after staged bladder reconstruction and bladder neck~     reconstruction.~      The aim of this study is to investigate the potential therapeutic effects of autologous~     myoblast injection for the treatment of children presenting with urinary incontinence after~     modern staged repair and bladder neck reconstruction of extrophy-epispadias complex as well~     as studying the safety, efficacy and durability of the procedure, and health related quality~     of life.~   "
114006|NCT02075203|"~     Randomized, Placebo Controlled, Partially Blinded Phase II Study to Evaluate Safety,~     Immunogenicity, and Prevention of Infection with Mycobacterium tuberculosis of AERAS-404 and~     BCG Revaccination in Healthy Adolescents~   "
114007|NCT02075190|"~     The objective is to examine the efficacy of computerized interventions for increasing~     well-being and cognitive functioning. The study will seek to validate emerging online~     delivery methods of psychiatric assessment and treatment. This will allow us to test the~     efficacy of this intervention in a larger and more geographically broad sample than is~     possible through traditional recruitment and treatment, and to do so in a highly~     cost-effective manner.~   "
114008|NCT02075177|"~     Currently there is no known effective treatment for recurrent/resistant neuroblastoma.~      Fenretinide is an anticancer agent that may work differently than standard chemotherapy~     medicines. It may cause the buildup of wax-like substances in neuroblastoma cancer cells,~     called ceramides or other chemicals, called 'reactive oxygen species'. In laboratory~     studies it was found that if too much ceramide or reactive oxygen species build up in~     neuroblastoma cells, they may die.~      In addition, researchers are testing to see if a drug called ketoconazole, commonly used to~     treat fungus infections, can increase fenretinide levels in the body by interfering with the~     body's ability to break down fenretinide.~      This study is being done: 1) to allow patients with recurrent/refractory neuroblastoma~     patients who would otherwise not be able to access fenretinide/LXS oral powder for treatment~     to do so; 2) to further describe the side effects of fenretinide and ketoconazole when given~     by mouth for seven days every three weeks; 3) to determine if a patient's tumor gets smaller~     after treatment with fenretinide oral powder plus ketoconazole or fenretinide oral powder~     alone.~   "
114009|NCT02075164|"~     Non-alcoholic fatty liver disease (NAFLD) comprises a spectrum ranging from simple fatty~     liver over steatohepatitis (NASH) to liver cirrhosis and cancer (HCC) and is a major and~     increasing health problem affecting nearly 40% of the general population. Moreover, NAFLD is~     an important risk factor for progression of diabetes and atherosclerosis. However, the~     pathomechanisms determining disease progression are poorly understood. The overall aim of~     this project is to test the central hypothesis that excessive fructose consumption provides a~     multiple metabolic hit in the pathogenesis and progression of NAFLD/NASH by impairment of~     hepatic lipid homeostasis and mitochondrial function resulting in hepatic lipotoxicity with~     inflammasome activation and disturbed interorgan cross-talk among insulin sensitive tissues.~   "
114010|NCT02075151|"~     According to World Health Organization (WHO) estimates, more than 200 million people suffer~     from asthma worldwide and in 2009, the disease had claimed 250,000 lives globally. Autopsy~     reports suggest 2 phenotypes of severe asthma: one that is characterized by intense airway~     inflammation with mucus plugging, and the other by severe bronchoconstriction causing~     respiratory failure in the absence of significant airway inflammation. However, it is not~     easy to stratify patients according to phenotypes without bronchoscopy. Although severe~     asthma comprises only 10% of affected individuals, it accounts for more than half of the~     total healthcare spending on asthma. Inhaled corticosteroids are effective by suppressing~     production of multiple pro-inflammatory mediators, unfortunately efficacy plateaus. Addition~     of long acting beta agonist and anti-cholinergic agent to inhaled corticosteroids offers some~     measure of relief but effective treatment of severe asthma remains an unmet goal, resulting~     in intensive utilization of healthcare resources. In 2010, the United States Food and Drug~     Administration (FDA) approved bronchial thermoplasty (BT) as an adjunctive therapy for severe~     asthma. BT is radiofrequency ablation of airway smooth muscle via bronchoscopy with each~     patient undergoing three procedures which targets different lobes of the lung 3 weeks apart.~     Studies have demonstrated improved symptom control allowing discontinuation of oral steroids~     in some patients as well as reductions in exacerbations, hospitalizations and use of rescue~     medications. No development of airway strictures or bronchiectasis, and regeneration of~     normal epithelium after BT has been observed. At present, it remains unclear if BT benefits~     all asthma phenotypes or if BT has any effect on airway inflammation and remodeling.~      The hypothesis of this study is that bronchial thermoplasty is likely to benefit all severe~     asthma phenotypes, and achieves this by exerting an effect on airway inflammation and~     remodelling.~      The specific aims of the study are: 1) to better define the asthma phenotype who will benefit~     from BT by microarray and gene expression profiling; 2) to study effects of BT on airway~     inflammation; 3) to define its role in the overall asthma management algorithm~   "
114011|NCT02075138|"~     Grass pollen allergens are universally recognised as a major cause of allergic diseases in~     humans, including asthma, allergic rhinitis, conjunctivitis and dermatitis.~      The purpose of the current study is to evaluate allergy symptoms and allergy medication in~     subjects with grass-related rhinoconjunctivitis.~   "
114012|NCT02075125|"~     To compare efficacy and safety of prasugrel and ticagrelor in patients with ST-segment~     elevation myocardial infarction undergoing primary percutaneous coronary intervention.~   "
114013|NCT02075112|"~     The purpose of this study is to determine if soy supplementation during chemotherapy and~     radiation therapy will decrease side effects caused by treatment. Long-lasting dry mouth is a~     side effect of the standard treatment, and we are testing whether soy supplementation during~     treatment may reduce this symptom and other side effects of chemoradiation.~   "
114039|NCT02074774|"~     The overall objective of this study is to demonstrate that the IntellO2 device providing~     automated control of fraction of inspired oxygen (FiO2) adjustments in spontaneously~     breathing infants with fluctuating arterial blood oxygen saturation levels is safe and~     efficacious in the routine clinical environment. Specifically, it is hypothesized that the~     IntellO2 will perform as well or better than standard practice for maintaining infants'~     arterial blood oxygen saturation in a target range while minimizing the exposure to elevated~     levels of oxygen in the inspired gas.~   "
114014|NCT02075099|"~     Blood donation is a generous act carried out by healthy male and female volunteer donors. The~     safety of blood donation in France is based on rigorous well documented biological and~     medical criteria, in particular concerning the volume of blood to be taken. While whole blood~     donation is very safe, some donors experience faintness during or after donation. Any injury~     resulting from a fall increases its seriousness, especially when it happens outside the~     donation site.~      According to various studies, adverse reactions are experienced by between 0.28% and 2.72% of~     all donors and occur in all categories (sex and age).~      A retrospective evaluation of the frequency of faintness incidents on during whole blood~     donation over 2012 in the Rhone Alpes' region of France shows a frequency ranging from 1.05%~     in mobile donation units in towns to 4.24% in donation units in high schools, with no~     reporting of delayed incidents of faintness by this donor population.~   "
114015|NCT02075086|"~     A group of colorectal cancer (CRC) patients treated with chemotherapy and Bevacizumab (Bev)~     maintain the same sensitivity after progression to maintenance treatment because they remain~     dependent on VEGF angiogenic mediator, while other patients in whom there is an angiogenic~     switch (AS) become dependent on other angiogenic cytokines and become resistant to Bev~     chemotherapy combinations .~   "
114016|NCT02075073|"~     The purpose of this study is to compare the pharmacokinetics, safety, tolerability and~     immunogenicity of SB3 and Herceptin® (EU sourced Herceptin® and US sourced Herceptin®) in~     healthy male subjects.~   "
114017|NCT02075060|"~     The aim of this pilot study is to assess the efficacy and toxicity of immediate pre-operative~     instillation of mitomycin C compared to the standard early post-operative .~   "
114018|NCT02075047|"~     The purpose of this study is to determine if ziprasidone is safe and effective for the~     treatment of children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed).~   "
114019|NCT02075034|"~     This study will compare the dosing regimen of oral rigosertib, which has been used in other~     studies of lower risk Myelodysplastic Syndrome (MDS), with 2 new dosing regimens to determine~     if one of the new regimens gives improved results as measured by disease status, side~     effects, and analyses of blood and urine samples.~   "
114020|NCT02075021|"~     The investigators will perform a phase I/II trial of Revlimid daily for 21 days and Abraxane~     weekly for 3 weeks. Accrual will be on standard cohorts of 3 patients. Once the maximum~     toxicity dose (MTD) is reached, the level below will be expanded to 25 patients for a pilot~     phase II trial. All treatments will be performed until progression. Assessments will be made~     at least at the 2, 4 and 6 month timepoints and monthly thereafter until progression.~      The purpose of this research study is to determine how much of the combination of Revlimid~     and Abraxane can be given safely and how well they work together against the cancer.~      Currently, this trial is in the phase 1 stage.~   "
114021|NCT02075008|"~     This study planned to assess long-term safety of QGE031 during 12 months treatment in asthma~     patients who completed study CQGE031B2201.~   "
114022|NCT02074995|"~     Study of tolerability and efficacy of BVS857 in severe burn subjects over 8 weeks and 15~     weeks~   "
114023|NCT02074982|"~     This study assessed efficacy of secukinumab, compared to ustekinumab, in patients that have~     plaque-type psoriasis~   "
114024|NCT02074969|"~     The purpose of this study is to assess the differences between two different types of devices~     for the treatment of unstable pertrochanteric hip fractures. The hypothesis of this study is,~     that patients who are treated with the proximal femoral Nail Antirotation (PFNA) have a~     better outcome and lower complication rates than patients treated with the Gamma Nail (GN3).~   "
114025|NCT02074956|"~     This Phase I study will be conducted as a randomized, double-blind, dose-escalation study in~     five groups of healthy adult male and female subjects who are BCG-vaccinated, HIV-negative,~     and have no evidence of tuberculosis infection. Since BCG-vaccinated individuals are the~     target population for which AERAS 404 might be indicated, AERAS 404 will be administered to~     individuals already vaccinated with BCG~   "
114026|NCT02074943|"~     The investigators plan to conduct a clinical trial to assess the effects and safety of~     platelet rich plasma on androgenetic alopecia.~   "
114027|NCT02074930|"~     It is an open-label physiological investigation of the allergic skin reactivity to~     epicutaneous allergen exposition in 20 allergic patients in two different skin conditions.~     The focus of the study is on the skin preparation/condition and not on the specific allergen~     or allergy, but for reasons of homogeneity a single allergic disease, birch pollen allergy~     was chosen as the basis for the testing. In order to evaluate the effects of the two~     different skin preparation techniques an intraindividual comparison of the skin reactivity in~     terms of the immediate phase I reaction to serial dilutions of birch pollen extracts was~     chosen. The serial dilution approach allows a dose dependent effect evaluation and comparison~     of the sensitivity. The differences will be explained mainly by the two different skin~     preparations allowing a quantitative comparison of these techniques.~   "
114028|NCT02074917|"~     This is a prospective, randomized and double-blind clinical trial about anatomical~     single-bundle anterior cruciate ligament (ACL) reconstruction.~      One of the most common causes of ACL reconstruction failure is poor graft positioning. There~     is evidence that graft placement aligned with native insertion sites results in superior~     clinical outcomes. Current anatomic ACL reconstruction concepts highlight the importance of~     the native anatomy to restore physiological knee kinematics more accurately.~      This study aims to investigate clinical outcomes and dynamic knee stability with force~     platform and other functional tests after ACL reconstruction in two different groups of~     tunnel position: anteromedial ACL footprint (AM) or central ACL footprint.~      It was hypothesized that there would be clinical or dynamic stability differences between AM~     or Central tunnel groups in ACL reconstruction.~   "
114029|NCT02074904|"~     The proposed project will utilize perfusion functional magnetic resonance imaging (fMRI) to~     examine the effects of topiramate on brain and behavioral responses in heavy drinkers to~     appetitive alcohol reminders (cues that motivate continued alcohol use and relapse). This~     project will yield novel findings on brain and behavioral responses to alcohol cues, the~     effects of topiramate on alcohol cue reactivity, and the mechanisms underlying topiramate's~     ability to blunt alcohol cue reactivity and heavy drinking.~   "
114040|NCT02074761|"~     Sacroiliac joint pain reduction and radiographic evidence of SIJ fusion will be collected to~     evaluate clinical performance of the SImmetry Sacroiliac Joint Fusion System.~   "
114031|NCT02074878|"~     This is a Phase 1 Trial. Crizotinib is a medication that is taken by mouth. It has shown that~     it can help slow down or stop the growth of tumor cells. The marketing name of the drug is~     Xalkori. It has been approved by the FDA (Food and Drug Administration) to treat other~     types of metastatic cancer, but the investigators believe it may be helpful to treat breast~     cancer as well.~      Sunitinib is the other medication used in the study. It is also taken by mouth in the form of~     a capsule. The marketing name of this drug is Sutent. It too has been approved by the FDA~     to treat other types of cancer, but not for breast cancer.~      In this study the investigators will be combining both of these two treatments, but at~     different doses.~      One third of the patients will take Crizotinib 200 mg, twice daily with Sunitinib 25.0 mg~     once a day.~      One third of the patients will take Crizotinib 250 mg, twice daily with Sunitinib 25.0 mg~     once a day, and One third of the patients will take Crizotinib 250 mg, twice daily with~     Sunitinib 37.5 mg once a day.~   "
114032|NCT02074865|"~     The main challenge of the ChARLI program is to assess the clinical burden of severe neonatal~     and childhood bacterial infections in low-income countries,in particular those caused by~     antibiotic resistant bacteria. This program will address both healthcare associated, as well~     as community acquired infections. Beside its main challenge, the ChARLI program will also~     allow the assessment of the economic burden of these infections, the improvement of their~     medical care and then ultimately help to set public health interventions and guide public~     health measures necessary to combat bacterial infections and bacterial resistance in~     children. It will also lead to set up more basic research investigation to better understand~     how pathogenic and epidemic may be the resistant clones in these countries and to experiment~     innovative strategies devoted to prevent these infections.~      In order to achieve these objectives, an international paediatric cohort will be created, and~     monitored a platform. This will be done first within the Institut Pasteur International~     Network (IPIN) and possibly extended in some others low income countries where the IPIN has~     no center. This constituted initiative will represent the first international pediatric~     program of its size to be located in low-income countries and specifically focusing severe~     bacterial infections and bacterial resistance to antibiotics~   "
114033|NCT02074852|"~     The objective this trial is to compare immediate and 12 hours postoperative removal of~     urinary catheter after elective cesarean section; and whether early removal is associated~     with lower risk of urinary infection compared with delayed catheter removal.~   "
114034|NCT02074839|"~     The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics,~     pharmacodynamics and clinical activity of AG-120 in advanced hematologic malignancies that~     harbor an IDH1 mutation. The first portion of the study is a dose escalation phase where~     cohorts of patients will receive ascending oral doses of AG-120 to determine maximum~     tolerated dose (MTD) and/or the recommended Phase II dose. The second portion of the study is~     a dose expansion phase where four cohorts of patients will receive AG-120 to further evaluate~     the safety, tolerability, and clinical activity of the recommended Phase II dose. Anticipated~     time on study treatment is until disease progression or unacceptable toxicity occurs.~   "
114035|NCT02074826|"~     This prospective, single-centre cohort study aims to investigate the association between~     known genetic Atrial Fibrillation (AF) risk variants and the amount of left atrial fibrosis~     found in patients undergoing clinically indicated AF catheter ablation procedures.~      Left atrial fibrosis is increasingly recognized as a fundamental part of the~     pathomorphological substrate creating an electrophysiological environment needed for~     electrical conduction heterogeneities. Such identification and treatment of left atrial~     fibrosis has already entered routine clinical use for RF catheter ablation in an attempt to~     develop an individualized and tailored treatment strategy. Today, it is unclear what impacts~     the development, the extent and the localization of left atrial fibrosis in different~     patients.~      A number of genetic risk variants have been described that confer risk of AF and have been~     widely replicated. This indicates that genetic variants contribute to the risk of the~     individual to develop AF throughout his life. However, the mechanisms of how genetic variant~     impact the development of clinical arrhythmias is not yet well understood.~      We hypothesize that genetic influences that lead to tissue changes may play a role in the~     development of the arrhythmia substrate for AF. This is likely to be especially true for~     those with a relatively brief history of AF and modest clinical disease burden. Therefore, we~     plan to investigate the association between known genetic AF variants and a detailed disease~     phenotype obtained from individual left atrial voltage mapping.~   "
114036|NCT02074813|"~     Demonstrate that IMT associated with a conventional pulmonary rehabilitation program allows a~     significant improvement of dyspnea in subjects with severe or very severe COPD than a~     conventional pulmonary rehabilitation program alone.~   "
114037|NCT02074800|"~     The purpose of Part 1 of this study is to assess the safety and tolerability of 2 dose levels~     (1.4 and 2.8 mg/kg) of CHO-derived CNTO 328 and Sp2/0-derived CNTO 328. The purpose of Part 2~     of this study is to access the pharmacokinetics (what the body does to the study medication)~     comparability of the 1.4 mg/kg dose of CHO-derived CNTO 328 and Sp2/0-derived CNTO 328.~   "
114038|NCT02074787|"~     Burn injuries are a common presentation to A&E in the UK (175,000 per year) of whom 13,000~     require hospital admission. Treatment of a single burn can cost more than £63,000, and is~     ultimately dependent on the depth. Most burns are assessed by experienced clinicians within a~     few days of injury. Accurate evaluation of burn depth can be very difficult with the naked~     eye. Inaccuracy can lead to longer hospital stays, worse scarring and greater financial costs~     for the NHS. Where the burn depth (and the degree of damage to the underlying blood supply of~     the skin) is not clear by visual inspection, adjuncts may be used to aid clinical~     decision-making. Currently, the gold standard method of assessing skin blood flow in order~     to help burn specialists in their assessment of burn depth is Laser Doppler Imaging (LDI).~     However, LDI machines can be very large, slow to collect the images, and a single imaging~     unit costs roughly £50,000. Consequently their use is restricted to the assessment of small~     burns in compliant patients treated in specialist units. Thermal imaging (thermography) has~     evolved rapidly as a useful diagnostic tool in many medical disciplines. Previous studies~     have shown that there are significant changes in skin physiology (such as temperature and~     pigmentation) depending on the depth of the burn. Portable, high-resolution thermal cameras~     are now affordable, easy to use and can provide numerical results in under a second.~     Similarly, measurement of skin pigment levels can be achieved using portable devices such as~     the Spectrophotometric Intracutaneous analysis scope (SIAscope). The aim of this study is to~     determine if alternative measures such as thermography or SIAscope can be as useful in the~     assessment of adult burns as LDI currently is. If this study demonstrates this then these~     results will inform further studies that would investigate these alternative imaging methods~     as a diagnostic and prognostic tool in the management of burns not only in adults but also in~     children presenting to non-specialised units such as A&E.~   "
114045|NCT02074696|"~     The purpose of the study is to assess the status of brain-derived neurotrophic factor brain~     (BDNF) and how the brain behaves in response to skill acquisition. Specifically we will~     investigate the relationship of the status of BDNF with cortical excitability changes and~     learning that occur during a motor training paradigm. We aim to 1) determine cortical~     excitability changes by using transcranial magnetic stimulation (TMS) before and after~     training; 2) to determine finger tracking accuracy before and after training; and 3)~     determine the presence of BDNF polymorphism in each participant.~      We are testing healthy adults in this study, and eventually would like to apply to persons~     who have neurologic disorders such as stroke or dystonia. By applying a magnetic field to the~     outside of the head, electrical currents are produced within the brain that can stimulate~     brain tissue. Using TMS, the brain can be studied to gain a greater understanding of the~     mechanisms associated with cortical excitability in healthy and patient populations. There is~     limited knowledge of what influence genetic biomarkers such as BDNF have on cortical~     excitability changes within the cortex following learning. Studies have indicated that people~     without this certain gene are less likely to show changes in brain excitability during TMS~     and during motor learning than people with this gene~   "
114046|NCT02074683|"~     The etiology of plantar fat pad atrophy may be age-related, due abnormal foot mechanics,~     steroid use, or collagen vascular disease. Displacement or atrophy of the fat pad can lead to~     osseous prominences in the forefoot that may be seen with painful skin lesions. Disease~     states, such as diabetes, may have loss of soft tissue integrity. Fat pad atrophy, regardless~     of the etiology, may result in significant pain, epidermal lesions, or metatarsalgia. In~     sensate patients, the pain can lead to emotional and physical pain, leading to productivity~     and financial losses.~      It is well documented that plantar pressure is directly correlated with plantar tissue~     thickness, with the loss of plantar fat being a fundamental mechanism for pressure related~     foot disorders.Autologous fat grafting to areas of plantar fat pad atrophy may reduce plantar~     pressures, and thus serve as a treatment for metatarsalgia, corn and callus prevention, and~     possibly ulcer prevention in diabetics. Plastic surgeons, with significant skills in fat~     grafting, can make a significant contribution.~      Current treatment modalities for fat pad atrophy include silicone injections, fat injections,~     and other temporary fillers; however, no objective studies using autologous fat have been~     performed. Approximately 30 adults who experience pain from fat pad atrophy, will have the~     option to participate. Through a randomized, controlled, cross-over study, some patients will~     receive autologous fat grafting, while some will receive standard of care podiatric~     treatment, then cross-over to fat grafting treatment after a year. Through pedobarograph and~     ultrasound assessments, the focal pedal pressure and tissue thickness following treatment~     will be documented over two years.~      We hypothesize that fat grafting for areas of increased pedal pressure in well-controlled~     diabetics will help decrease foot pressure during gait and increase soft tissue thickness on~     the foot pad, ultimately reducing pain. We also hope to demonstrate that by using autologous~     fat with evidence-based fat transfer techniques, results may be durable. This pilot study~     will help build new collaborative efforts between Foot and Ankle Surgery, Podiatry and~     Plastic Surgery, combining expertise in foot biomechanics with reconstructive fat grafting.~   "
114047|NCT02074670|"~     The purpose of this study was to evaluate the potential reorganization in the sensorimotor~     cortex in spinal cord injury (SCI) patients after Body Weight Supported Treadmill Training~     (BWSTT) associated with conventional motor rehabilitation. The investigators hypothesized~     that training with weight bearing associated with conventional motor rehabilitation will be~     able to reorganize the brain.~   "
114048|NCT02074657|"~     To determine safety profile of immunotherapy with natural killer cells and activated expanded~     (NKAEs) after salvage chemotherapy in children, adolescents and young adults with relapsed or~     refractary acute leukemia~   "
114049|NCT02074644|"~     The purpose of this study is to determine whether prostatic arterial embolization (PAE)~     compared is an effective and safe treatment for benign prostatic hyperplasia in patients with~     severe lower urinary tract symptoms not adequately controlled by medical therapy with~     alpha-blockers, as assessed by the the International Prostate Symptom Score (IPSS) after 6~     months. Patients will be randomized on a 1:1 ratio to PAE or to a sham procedure and~     evaluated at 1, 3 and 6 months. Patients randomized to the sham procedure will be offered the~     possibility of performing PAE after 6 months. All patients may participate on an optional~     6-months extension study.~   "
114050|NCT02074631|"~     This is a Phase 2, open-label, randomized, controlled clinical study of pediatric subjects~     treated with pamidronate with calcium and vitamin D versus calcium and vitamin D alone~     following hematopoietic cell transplantation (HCT). The purpose of this study is to test the~     hypothesis that subjects receiving pamidronate with calcium and vitamin D will have higher~     lumbar spine bone mineral content (LBMC) measured by dual-energy X-ray tomography (DXA) at 1~     year post-HCT than subjects receiving calcium and vitamin D alone (Control Group).~   "
114051|NCT02074618|"~     The purpose of this study was to evaluate the effects of physiotherapy based on the practice~     of supervised exercise on functional capacity and life quality of patients with chronic~     kidney disease.~   "
114052|NCT02074605|"~     Interferon alpha is the only approved adjuvant biologic therapy for individuals diagnosed~     with high risk malignant melanoma (stage 2 or 3). There is evidence that interferon has some~     adverse cognitive effects on patients, but there are limited data. The investigators~     hypothesis is that compared to patients with melanoma who do not receive interferon, patients~     who have melanoma and are treated with interferon will show an objective decrease in~     performance on neurocognitive assessment.~      This study will enroll patients with melanoma who qualify for interferon, and either decide~     to undergo interferon treatment or choose watchful waiting instead. All patients will be~     assessed with a cognitive testing battery twice. Observation patients will undergo testing at~     their first appointment in which they consent to the study, as well as at their next~     physician visit, approximately 3 months from the first visit. Interferon patients will be~     tested immediately prior to starting interferon, as well as immediately after completing high~     dose interferon.~   "
114053|NCT02074592|"~     To improve the quality of fetal ultrasound images, self assessment is less resource consuming~     than assessment by an expert reviewer, and may be as effective.~      To test this hypothesis, we randomize volunteer experienced ultrasonographers into two~     groups.~      One group assess their own images (self assessment). The other group has their images~     assessed by an expert. Images are audited via the internet in a standardized procedure that~     generates feedback with recommendation for change.~      Three to 6 months later, participants are audited again. If the improvement in image quality~     turns to be the same in both groups, it will be likely that self assessment is indeed as~     effective as assessment by an expert reviewer - at least for professionals experienced in~     fetal ultrasound.~   "
114054|NCT02074579|"~     The aim of this study is to assess the effect of orally administered TU-100 (5 g three times~     daily [TID]) as compared to placebo on abdominal bloating rating in female IBS patients.~   "
114055|NCT02074566|"~     Cryoballoon based therapy is an established therapy for the treatment of (paroxysmal) atrial~     fibrillation. However, with the rapid evolution in cryoablation technique and its increased~     effectiveness, the risk of complications increases. Therefore it is of utmost importance to~     define the optimal duration of cryoballoon ablation time.The objective of the study is to~     assess the optimal ablation duration using the second generation cryoballoon for isolation of~     pulmonary veins in the treatment of atrial fibrillation.~   "
114056|NCT02074553|"~     This 2-part, single center, open-label, randomized, single-dose, 4-sequence, 4-period~     cross-over study will compare the bioequivalence of three test alectinib capsule formulations~     with the reference capsule formulation in healthy adult participants. All participants in~     both fasted (Part 1) and fed (Part 2) conditions of the study will receive each of 4~     treatments: Treatment A (alectinib with 50 percent [%] sodium lauryl sulfate [SLS]~     [reference]), Treatment B (alectinib with 25% SLS [test]), Treatment C (alectinib with 12.5%~     SLS [test]), and Treatment D (alectinib with 3% SLS [test]) in a randomized sequence. Each~     treatment will be given as a single 600 milligrams (mg) oral administration in an upright~     position on Day 1 in a fed or fasted condition, followed by a 10-day washout period.~   "
114057|NCT02074540|"~     To determine the predicting factors and indicators of compliance with insulin treatment in~     Diabetes Type II patients.~   "
114058|NCT02074527|"~     Design: Observational - Cross study with followed up for 30 days. The Primary Objective is to~     realize a record that reflects a national overview of the role of cardiac catheterization in~     patients with congenital heart disease in hospitals distributed by geographic density of each~     region of Brazil.~   "
114059|NCT02074514|"~     This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF)~     + ribavirin (RBV) in treatment-naive adults with chronic genotype 1 or 3 hepatitis C virus~     (HCV) infection.~   "
114060|NCT02074501|"~     Background: More than 42% of older people (aged +65) have a stroke and most of them require~     some type of help to self-care at home. Informal caregivers have reported different types of~     need and have shown dissatisfaction with technical and emotional support delivered by~     community health teams. Furthermore, empowering informal caregivers who care after older~     stroke survivors is an important challenge, preventing them from negative outcomes such as~     burden, anxiety and depression or loss of physical function or hospitalization in older~     people.~      Objectives: This pilot study aims to implement and evaluate the impact of an intervention~     based on training and telephone support delivered to informal caregivers who care after older~     people post-stroke.~      Setting: Community health units in Northern Portugal region. Design/Methods: This single~     blinded randomized trial will be delivered by a community nursing team to informal caregivers~     1 week, 1 and 3 months after a hospital discharge.~      Study outcome(s): The primary outcomes will be informal caregivers´ empowerment. Secondary~     outcomes will include burden and health quality of life in caregivers; functionality,~     hospital readmission and institutionalization of older people stroke survivors, measured 1~     and 3 months after intervention.~      Results/Conclusion: Data collection started in February and will be concluded in August 2014.~     First results will be published at the beginning of 2015. The InCARE programme will be the~     first pilot in informal caregivers study ever conducted in Portugal. It will highlight new~     ways to support caregivers who take care of older people after a stroke. If successful, this~     study will be translational and it will also allow to disseminate the results in Portugal and~     abroad and implement it as best practice.~   "
114061|NCT02074488|"~     Falls are a significant issue for older adults with vision impairment. Medical conditions~     such as glaucoma and age-related macular degeneration that result in vision impairment~     negatively impact balance. Falling is 1.7 times more likely among older adults with vision~     impairment. In 2010 there were 9,146,026 older adults treated in emergency rooms for~     unintentional falls and injuries from falls are expected to cost the nation an estimated~     $54.9 billion dollars by 2020. Falls can lead to death, depression, and loss of independence.~     However, impaired balance is a modifiable risk factor for falls. A practical yet innovative~     falls prevention program has been developed that is designed to enhance balance and~     proprioception among older adults. This program, UExCEL (UNE-Exercise and Conditioning for~     Easier Living) Balancing Act, consists of simple exercises that can be done at home (15~     minutes duration-3 times a week) during normal daily activities, requires only one brief~     training session, and no equipment. This study aims to establish an evidence base documenting~     the positive impact of Balancing Act exercises on balance and falls prevention for older~     adults with vision impairment. A randomized controlled trial of older adults with vision~     impairment (best corrected vision of 20/70 or worse) will be conducted over a 6-month period~     (control group n = 35 and Balancing Act intervention group n = 35) to determine the impact of~     Balancing Act on falls, fear of falling, pain, and activity levels. Factors that can be~     expected to affect its adoption and sustained use such as cost in the community and social~     support networks in the home will also be investigated. It is hypothesized that the Balancing~     Act intervention will decrease the number of falls experienced by older adults who have~     vision impairment by improving their gait and balance, reducing their fear of falling,~     increasing their physical activity, and reducing their pain.~      The specific aims of the research are to: 1) Evaluate the impact of Balancing Act on standing~     balance control and proprioception for older adults who have vision impairment, using the~     Tinetti Gait & Balance Test, a validated tool for evaluating gait and balance and predicting~     fall risk; 2) Evaluate the impact of Balancing Act for older adults with vision impairment on~     falls, fear of falling, physical activity, and pain; and 3) Improve adherence to the~     Balancing Act exercise program by facilitating social networks. Data will be analyzed~     through: 1) a descriptive assessment of the baseline demographic characteristics of sample~     members, covariates, and outcome variables, as well as 2) a repeated measures design~     examining the impact of the intervention on study participants.~   "
114062|NCT02074475|"~     Primary endpoint: Defining The optimal target range for Surgical Pleth index. Surgical Pleth~     Index (SPI, formerly used SSI = Surgical Stress Index) is a novel multivariate index, which~     is based on the sum of the normalized pulse beat interval (PBI) and the photoplethysmography.~     SPI indicates the balance between intensity of surgical stimulation and the level of~     anti-nociception (opioid analgesia and neural blockade). This study is a Spin off from a~     larger Adequacy of Anaesthesia study and aims on finding the most appropriate target range~     for SPI in order to avoid signs of inadequate anaesthesia. Patients are treated without~     monitoring adequacy of anaesthesia thus the values are collected blinded and analyzed~     afterwards in accordance of signs for inadequate anaesthesia. The study population will be~     150 patients.~   "
114063|NCT02074462|"~     Voriconazole is a broad-spectrum antifungal agent. There is evidence for a relation between~     the efficacy and safety of voriconazole and voriconazole trough concentrations. There are~     several factors that could influence voriconazole concentrations. Inflammation could be one~     of these factors. In a retrospective study was observed that reduced metabolism of~     voriconazole was related to inflammation in patients with severe infections. Reduced~     metabolism of voriconazole resulted in high voriconazole levels and low N-oxide metabolite~     (inactive metabolite of voriconazole) levels. The purpose of this study is to determine an~     algorithm to guide dosing of voriconazole during severe inflammation and to develop a~     multiple linear regression model to describe the contribution of CRP concentrations to the~     variability in voriconazole levels and metabolic ratio.~   "
114064|NCT02074449|"~     Patients with pulmonary arterial hypertension (PAH) are at much higher risk of death if the~     RV (right ventricle) is weak. The purpose of this study is to get a better understanding of~     the factors that determine RV adaptation and how the RV compensates on therapy. The~     investigator is also interested in how Remodulin (treprostinil) infused over a short period~     (approximately 48-72 hours) affects the patient's quality of life, medical care, and personal~     health behaviors.~      Treprostinil, also known as Remodulin, has been approved by the US Food and Drug~     Administration for use in the treatment of PAH. The investigator has been treating patients~     with Remodulin by rapid infusion (over 48 hours) for over 6 years. The investigator would~     like to establish this practice as safe and effective for the benefit of other centers that~     treat PAH.~   "
114065|NCT02074436|"~     STUDY BACKGROUND AND PURPOSE:~      Patients with hematological malignancies (blood-related cancers) often develop~     thrombocytopenia (low platelet count), which can be made worse by cancer treatment.~      Preventive (prophylactic) platelet transfusion remains the standard of care for~     thrombocytopenic patients. However, bleeding remains a significant problem in these patients,~     affecting approximately 20% of patients with acute myeloid leukemia and 34-58% of~     hematopoietic stem cell transplant recipients. Platelet transfusion refractoriness, the~     repeated failure to obtain satisfactory response to platelet transfusions, is a common~     problem. Alternatives to platelet transfusions are desperately needed for these patients.~      Epsilon aminocaproic acid (EACA) blocks a process called fibrinolysis that is an essential~     step in the bleeding process. EACA is approved by the FDA for the treatment of severe~     bleeding-related diseases and complications. A small study has shown EACA to be well~     tolerated and associated with low risk of bleeding in patients with hematological~     malignancies.~      This study will compare EACA versus standard prophylactic platelet transfusion for the~     prevention of bleeding in thrombocytopenic patients with hematological malignancies.~      STUDY DESCRIPTION:~      This is Phase II study to compare EACA versus standard prophylactic platelet transfusion to~     prevent bleeding in thrombocytopenic patients with hematological malignancies. Patients who~     are eligible to take part must give their written agreement before they can be enrolled.~      The study will enroll 100 patients who will be assigned randomly to take EACA twice daily or~     to undergo standard prophylactic platelet transfusion. Patients will be followed for any~     bleeding events, need for platelet transfusion, and any side effects experienced. Patients~     will complete questionnaires to assess their quality of life while on the study.~   "
114066|NCT02074423|"~     The purpose of the study is to evaluate the effect of MealShape, a Ceylon cinnamon extract~     (Cinnamomum zeylanicum) on blood glucose and insulin response after consumption of a standard~     meal composed of white bread, in healthy male and female volunteers.~   "
114067|NCT02074410|"~     The purpose of this study is to determine the safety, tolerability and pharmacokinetics of~     OMS643762 (the study drug) in subjects with Huntington's disease (HD).~   "
114068|NCT02074397|"~     The objective of this randomized controlled trial is to compare the analgesic efficacy and~     the safety profile between two techniques of injection for the interscalene block. The~     interscalene block consists of injecting local anesthetic around the cervical roots of the~     brachial plexus and allows analgesia after shoulder surgery.~      Stated differently, the dual objective of that study is:~        1. to confirm that an injection at a distance of 4 mm away from the lateral sheath of the~          plexus (distal injection) provides similar analgesia as a classical injection within the~          plexus (subfascial injection);~        2. to demonstrate that a distant extrafascial injection produces less respiratory~          complications than a subfascial injection, defined as hemidiaphragmatic paresis.~   "
114069|NCT02074384|"~     International Diabetes Center (IDC) proposes a preference and usability study of glucose data~     acquisition and reporting, evaluating streamlined standardized cloud-based glucose reporting~     including work flow as well as patient and clinician preference at Type 1 Diabetes (T1D)~     Exchange sites to enhance standard Ambulatory Glucose Profile (AGP) reporting. This phase 2~     project assesses the efficacy of standardized glucose data report generation and preferred~     report presentation format; both are necessary to increase use of continuous glucose~     monitoring (CGM) data to improve care processes and outcomes for Type 1 diabetes.~   "
114070|NCT02074371|"~     Coronary artery bypass graft surgery (CABG) is associated with postoperative respiratory~     depression. In this study we aimed at investigating perioperative parameters that could~     predict the nadir of postoperative respiratory function impairment.~   "
114071|NCT02074358|"~     The purpose of this study is to assess the effect of two 4-Factor PCC formulations on~     Apixaban pharmacodynamics in healthy adult subjects.~   "
114072|NCT02074345|"~     The purpose of this study is to evaluate the safety and immunogenicity of intramuscular~     TAK-816 in healthy Japanese infants.~   "
114073|NCT02074332|"~     The primary objective of this study is to assess the effectiveness of a school based physical~     activity programme on obesity and related health outcomes in young schoolchildren.~   "
114074|NCT02074319|"~     The aim of the this study is to evaluate the effectiveness of methotrexate added to treatment~     as usual on positive and negative symptoms, cognitive and social functioning and quality of~     life of patients suffering from schizophrenia.~   "
114075|NCT02074306|"~     The purpose of this study is to examine the effect of UROSHIELD® (a device which generates~     low energy ultrasound waves) on development of bacterial colonies on endotracheal tubes, in~     patient receiving mechanical ventilation, and to determine whether this device lowers the~     rate of bacterial resistance to antibiotics.~   "
114076|NCT02074293|"~     Botox acts on nerve endings, yet there are no nerve endings inside the muscle, where they are~     typically injected. All nerves terminate on the fascia, where ASIS device can precisely~     deliver Botox by creating that subdermal bloodless space, between the skin and muscle. Thus~     enhancing and prolonging Botox's efficacy, at the same time prevent it's unnecessary adverse~     reactions and distant spread, especially since Botox has no reason to travel to the rest of~     the body any way.~   "
114077|NCT02074280|"~     Cirrhotic patients are predisposed to intestinal dysmotility, bacterial overgrowth, and~     increased intestinal permeability all leading to an increase in bacterial translocation and~     increased endotoxemia. Rifaximin is an antibiotic that is virtually non-absorbed after oral~     administration and exhibits broad spectrum antimicrobial activity against both aerobic and~     anaerobic gram-positive and gram-negative microorganisms within the gastrointestinal tract.~     It has been suggested that oral prophylactic antibiotics or bowel decontamination might~     improve long-term outcomes in patients with cirrhosis. The aim of this study was to explore~     the suitable dose of rifaximin to alleviate endotoxemia and prevent the complications of~     advanced cirrhosis.~   "
114078|NCT02074267|"~     The purpose of this study is to assess the efficacy of Gabapentin (Carbatin & Neurontin) in~     patients with neuropathy pain.~   "
114079|NCT02074254|"~     Safety of Percutaneous Tracheostomy in Clopidogrel and Selective Serotonin Reuptake~     Inhibitors~   "
114080|NCT02074241|"~     The purpose of this study is to try to figure out some bio-markers of chemosensitivity for~     adjuvant chemotherapy for bladder cancer.~   "
114081|NCT02074228|"~     Attention deficit hyperactivity disorder (ADHD), characterized by inattention, hyperactivity~     and impulsivity, is an early onset, highly heritable, clinically heterogeneous, long-term~     impairing disorder with tremendous impact on individuals, families, and societies. It affects~     5-10% of school-aged children worldwide (7.5% in Taiwan) and 2-4% of adults. Although the~     efficacy of medications for ADHD is well demonstrated in clinical trials, substantial numbers~     of patients fail to remain on therapy, and there is tremendous variability in tolerability~     and treatment acceptance. It is of great interest to identify biomarkers relating to~     medication response in ADHD. However, the procedure for obtaining central markers such as PET~     scan is invasive and expensive. Previous studies have found that mRNA expression of~     neurochemical markers in circulating blood can reflect the neurochemical levels in the brain.~     Further studies to identify peripheral biomarkers related to medication response in ADHD are~     warranted.~   "
114082|NCT02074215|"~     Recent studies have shown that aerobic exercises and dual-task training are effective in~     improving overall cognitive function in patients with cognitive impairment or dementia.~     However, the biological mechanisms are unknown in humans. It also remains unclear regarding~     whether carrying APOEε4 genotype or not would influence the effects. Therefore, the three~     main purposes of this study are: (1) to investigate the effects of a 3-month aerobic~     exercises combined with dual-task training on memory and executive cognitive functions in~     patients with mild cognitive impairment (MCI) and in those with early Alzheimer's disease~     (AD); (2) to compare the differences in training effects between patients who carry APOEε4~     genotype and those who do not carry this genotype; and (3) to investigate the biological~     mechanisms of the exercise training effects on memory and executive cognitive function in~     these patients. The biological mechanisms of interest will include the blood Aβ1-40 and~     Aβ1-42 level, insulin, fasting glucose, cytokine, integrity of brain fiber tracts, and~     cerebral blood flow.~      We will conduct a randomized controlled clinical trial. A total of 70 patients with MCI or AD~     will be recruited. The participants will be randomly assigned to the experimental group or~     the control group. Both groups will receive three 90-minute exercise sessions per week for 12~     weeks. For the experimental group, the exercise program will include moderate intensity~     aerobic exercises and dual-task training; whereas for the control group, the training program~     will include gentle stretching exercises. Both groups will receive examinations on outcome~     variables, including blood Aβ1-40 and Aβ1-42 level, insulin, fasting glucose,~     cytokine,integrity of brain fiber tracts, cerebral blood flow, cognitive function, and dual~     task performance at baseline, post-training, and after a 3-month follow-up period.~     Differences on the aforementioned outcomes brought by the 12-week training programs will be~     compared between the experimental and control groups. Exercise effects between patients who~     carry APOEε4 genotype and those who do not will also be examined.~      Results of this study will provide relevant clinical evidence for the effects of aerobic~     exercises combined with dual-task training on patients with MCI and mild AD; and will provide~     further understanding of the mechanisms mediating these effects.~   "
114083|NCT02074202|"~     Liver cancer is a major cause of death among patients of east or southeast asian descent, as~     well as other population groups, notably in central and west Africa. Diagnosis of liver~     cancer requires a combination of several imaging techniques and biopsies. Despite this,~     diagnosis can remain inconclusive or difficult to establish in patients at risk for liver~     cancer.~      The purpose of this multi-center trial is to evaluate novel imaging methods developed to~     diagnose the most common form of liver cancer, hepatocellular carcinoma. We propose to use~     novel imaging probes that have been reported to bind to liver cancers but not benign liver~     lesions that can be confused with liver cancer. Two such imaging probes will be evaluated.~     2-[18F]-fluoro-2-deoxy-D-glucose, called [18F]FDG, is a radioactive sugar that is widely used~     for cancer imaging with a device called positron emission tomography, or PET scans. We~     already know that [18F]FDG cannot detect some liver cancers that are slow growing.~     [18F]Fluorocholine ([18F]FCH), another molecule, has been recently reported to be highly~     effective at detecting liver cancer. In 2010, a French researcher reported 80-90% detection~     rate by using [18F]FCH alone or in combination with [18F]FDG.~      We will compare [18F]FCH and [18F]FDG in evaluating 150 patients over a period of two years.~     The results will be correlated with those of biopsies and clinical follow-up.~      This study will provide valuable data on whether these imaging agents can successfully~     differentiate malignant liver lesions from benign ones. It will also provide information~     about whether these imaging agents can successfully assess whether the cancer has spread~     outside the liver. It will provide data that will allow physicians to determine the optimal~     imaging protocol to properly diagnose liver cancer.~   "
114084|NCT02074189|"~     Effect of adjuvant chemotherapy to control tumor progression in patients after cystectomy for~     locally advanced bladder cancer.~   "
114085|NCT02074176|"~     Background: Attention deficit hyperactivity disorder (ADHD) is an early onset, highly~     heritable, clinically heterogeneous, long-term impairing disorder with tremendous impact on~     individuals, families, and societies. It affects 7.5% of school-aged children in Taiwan.~     Emerging evidence has suggested that patients with ADHD may present with a deficit of~     attention, alertness and sleep disturbances. Since attention, alertness, and sleep~     disturbances may significantly increase the functional impairment of ADHD, gaining insight~     into their pathophysiology as well as into their treatment is of relevance to provide a~     better clinical management of patients suffering from ADHD. The orexin system, located in the~     hypothalamus, takes an important role in homeostatic functions, such as attention, alertness,~     sleep-wake cycle, and feeding. To our best knowledge, the functioning of the orexin system~     has never been investigated in patients with ADHD. Given the involvement of the orexin system~     in the control of alertness and reward seeking, the present study aims to examine whether~     plasma orexin and mRNA expression levels of pre-pro-orexin gene are associated with the~     symptoms and neurocognitive deficits of ADHD.~   "
114086|NCT02074163|"~     Botox acts on nerve endings, yet there are no nerve endings inside the muscle, where they are~     typically injected. All nerves terminate on the fascia, where ASIS device can precisely~     deliver Botox by creating that subdermal bloodless space, between the skin and muscle. Thus~     enhancing and prolonging Botox's efficacy, at the same time prevent it's unnecessary adverse~     reactions and distant spread, especially since Botox has no reason to travel to the rest of~     the body any way.~   "
114087|NCT02074150|"~     Botox act on nerve endings, yet there are no nerve endings inside the muscle, where they are~     typically injected. All nerves terminate on the fascia, where ASIS device can precisely~     deliver Botox by creating that subdermal bloodless space, between the skin and muscle. Thus~     enhancing and prolonging Botox's efficacy, at the same time prevent it's unnecessary adverse~     reactions and distant spread, especially since Botox has no reason to travel to the rest of~     the body any way.~   "
114088|NCT02074137|"~     Primary Objective:~      To evaluate the safety of cabazitaxel (Jevtana) in patients with metastatic hormone~     refractory prostate cancer~      Secondary Objectives:~        1. To describe the use of cabazitaxel (Jevtana) in combination with oral prednisolone for~          the treatment of patients with metastatic Hormone Refractory Prostate Cancer~        2. To describe patient profile in terms of demography, disease characteristics and prior~          treatment history~        3. To describe efficacy outcomes: radiological response (if available) using Recist~          criteria V 1.1 and Prostate Specific Antigen (PSA) response~   "
114089|NCT02074124|"~     The aim of this study was to investigate changes in abdominal tissue perfusion during~     adenosine vasodilation. Our hypotheses were that CT perfusion measurements are altered by~     changes in the circulatory system mediated by adenosine, and a more differentiated assessment~     of the circulatory capacity of abdominal tumours could be achieved by sequential rest and~     adenosine vasodilation CT perfusion measurements.~   "
114090|NCT02074111|"~     The aim of this study is to investigate the proportion of patients with moyamoya disease~     among the patients who were diagnosed as having intracranial atherosclerotic stroke. To do~     this, biomarkers (gene and imaging) for moyamoya disease are tested and follow up angiography~     are performed during follow up (in selected patients).~   "
114091|NCT02074098|"~     The purpose of this study is to determine whether a bed height make an effect to endotracheal~     intubation with Macintosh laryngoscope, Glidescope and Airwayscope during chest compressions~     in- hospital simulation cardiac arrest.~   "
114092|NCT02074085|"~     An ADE is defined as harm caused by a drug or the inappropriate use of a drug. Retrospective~     record reviews in several countries have shown that anticoagulants frequently lead to~     hospital readmissions. In this study a hospital readmission is defined as an admission to the~     emergency department of the Jessa hospital. The objective of this study is to determine the~     incidence of one week and 30-day readmissions caused by (preventable) ADE's due to~     anticoagulants.~   "
114093|NCT02074072|"~     European Resuscitation Council (ERC) Guidelines for Resuscitation 2010 emphasize high quality~     chest compressions .They propose minor changes for pregnant women: manual left deviation of~     the uterus or a left-lateral incline of 15-30to alleviate pressure on the inferior vena cava.~     We will examine the performance of the Glidescope (GVL), the Pentax-AWS Airwayscope(AWS) and~     Macintosh laryngoscope (McL) for airway management during chest compressions on 15 and 30~     degree left-lateral tilt (15 &30 LLT) custom-made hard wedges.~   "
114094|NCT02074059|"~     The primary objective of this study is to evaluate the safety and tolerability of aerosolized~     surfactant, specifically lucinactant for inhalation, administered in escalating inhaled doses~     to preterm neonates 29 to 34 weeks gestational age who are receiving nasal continuous~     positive airway pressure (nCPAP) for respiratory distress syndrome (RDS), compared to~     neonates receiving nCPAP alone.~   "
114095|NCT02074046|"~     Most studies of cancer stem cells (CSC) involve the inoculation of cells from human tumors~     into immunosuppressed mice, preventing an assessment on the immunologic interactions and~     effects of CSCs. In this study, the investigators examined the vaccination effects produced~     by CSC-enriched populations from histologically distinct murine tumors after their~     inoculation into different syngeneic immunocompetent hosts. Enriched CSCs were immunogenic~     and more effective as an antigen source than unselected tumor cells in inducing protective~     antitumor immunity.Immune sera from CSC-vaccinated hosts contained high levels of IgG which~     bound to CSCs, resulting in CSC lysis in the presence of complement.CTLs generated from~     peripheral blood mononuclear cells or splenocytes harvested from CSC-vaccinated hosts were~     capable of killing CSCs in vitro. Mechanistic investigations established that CSC-primed~     antibodies and T cells were capable of selective targeting CSCs and conferring antitumor~     immunity.~   "
114096|NCT02074033|"~     The infection is a major risk to hospitalized patients, especially those admitted to the~     Intensive Care Unit (ICU) and an unfavorable factor in the outcome of critically ill~     patients, increasing costs and prolonging hospitalization hospitalar. The~     ventilator-associated pneumonia (PAV) is considered the most prevalent nosocomial infection~     in the ICU, occurring in 9% to 68% of patients with prosthetic ventilatória.Due to the high~     rate of PAV and mortality related to it, is very important both prescription and~     administration of antibiotics correctly, as deescalation or escalation according the result~     of cultures.Therefore, the objectives of this study is assess if whether the antibiotic~     prescribed of ventilator-associated pneumonia following the orientation of literature. Will~     also be assessed the rate of PAV in patients critically ill adults, the main microorganisms~     responsible by PAV and determining antimicrobial susceptibility.~   "
114097|NCT02074020|"~     The purpose of this study is to evaluate the clinical efficacy of blisibimod as measured by a~     composite responder index in subjects who, despite corticosteroid use, continue to have~     autoantibody positive, clinically-active Systemic Lupus Erythematosus (SLE) as defined by~     SELENA SLEDAI score ≥10.~   "
114098|NCT02074007|"~     Children ages 2 months to less than 19 years old, who have been diagnosed with a middle ear~     infection may receive either medicated ear drops (AR01) or glycerin (placebo) ear drops. The~     patient or caregiver will measure the amount of ear pain before and after the ear drops to~     establish if the medicated ear drops decrease the amount of pain more than the placebo ear~     drops. The subject may leave the clinic 60 minutes after the first dose. The ear drops can be~     used up to 4 days, as needed for ear pain.~   "
114099|NCT02073994|"~     The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics,~     pharmacodynamics and clinical activity of AG-120 in advanced solid tumors, including glioma,~     that harbor an IDH1 mutation. The first portion of the study is a dose escalation phase where~     cohorts of patients will receive ascending oral doses of AG-120 to determine maximum~     tolerated dose (MTD) and/or the recommended Phase II dose. The second portion of the study is~     a dose expansion phase where four arms of patients will receive AG-120 to further evaluate~     the safety, tolerability, and clinical activity of the recommended Phase II dose. Anticipated~     time on study treatment is until disease progression, unacceptable toxicity occurs or at~     Investigator discretion.~   "
114100|NCT02073981|"~     This study is implemented to identify factors having an impact on improvement or exacerbation~     of non-motor symptoms, to provide information contributing to development of medical care in~     this field and improvement of patients' QOL, and to clarify the association between the use~     of istradefylline and non-motor symptoms or QOL.~   "
114101|NCT02073968|"~     This phase II trial studies how well intensity modulated radiation therapy adjusted by~     positron emission tomography (PET) scanning together with combination chemotherapy works in~     treating patients with stage II-IV non-small cell lung cancer (NSCLC). Radiation therapy uses~     high energy x rays to kill tumor cells. In intensity-modulated radiotherapy, multiple beam~     angles and dozens of beam segments are used to deliver highly conformal radiation therapy.~     Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Giving PET-adjusted IMRT together with combination chemotherapy may kill more tumor~     cells.~   "
114102|NCT02073955|"~     This is a validation study. A stroke symptom questionnaire will be adapted and translated~     into local language. Two community health workers will be trained in its administration.~     Their findings will be validated against assessment by two neurologists.~      The study hypothesis is that the chance corrected agreement between the community worker~     administered stroke symptom questionnaire and the assessment by neurologist based on history~     and physical examination is at least moderate.~   "
114103|NCT02073942|"~     The wearable cardiac defibrillator (WCD) is an alternative to the implantation of~     cardioverter defibrillator (ICD) for patients at high risk for sudden cardiac death (mostly~     bridging therapy). The Cologne register of wearable defibrillator (CRWD) is a prospective~     register for all patient with an indication of wearable defibrillator.~   "
114104|NCT02073929|"~     Polycystic ovary syndrome (PCOS) affects 5-10% of women in fertile age. PCOS is associated~     with metabolic syndrom, diabetes and and increased risk og cardiovascular disease.~      The study investigates the effect af intervention with GLP-1-analog on risk markers of~     cardiovascular disease in women with PCOS.~      70 women will be included in af RCT.~      Hypothesis: GLP-1-analog treatment in women with PCOS (without diabetes) will result in a~     beneficial reduction in risk markers of vascular thrombosis and early cardiovascular disease.~   "
114105|NCT02073916|"~     This open-label, single-center study will assess the safety and tolerability of combining~     trastuzumab emtansine (T-DM1) to Lapatinib and Abraxane in patients with metastatic~     HER2-positive breast cancer. Patients will receive Abraxane on Day 1 of each 1-week cycle and~     T-DM1 on Day 1 of each 3-week cycle. Patients with take Lapatinib orally daily. Anticipated~     time on study treatment is up to 12 weeks for patients metastatic breast cancer, until~     disease progression or unacceptable toxicity occurs. Subjects may continue on treatment past~     12 weeks if responding to study treatment.~      The purpose of this study is to test the safety of Trastuzumab Emtansine in combination with~     Abraxane and Lapatinib at different dose levels. The investigators are proposing in this~     phase Ib study to assess the maximum tolerated dose (MTD) of Trastuzumab Emtansine in~     combination with Lapatinib plus Abraxane in metastatic Her2 over-expressed breast cancer.~      The investigators hypothesize that combining antibody-drug conjugate trastuzumab-emtansine~     and lapatinib together with Abraxane will improve clinical efficacy by affecting both PI3K~     and ERK1,2 MAPK pathways.~   "
114106|NCT02073903|"~     The purpose of this study is to introduce new technology and interpreter practices in the~     inpatient setting at MSKCC. We plan to install dual handset phones at the bedsides of limited~     English proficiency (LEP) patients and to assess the impact on both patient and physician~     communication effectiveness with this technology.~   "
114107|NCT02073890|"~     Traumatic brain injury is common cause of morbidity and mortality worldwide. Incidence and~     pattern of traumatic brain injury varies in developed and developing countries. Subarachnoid~     haemorrhage refers to blood in subarachnoid space that lies between arachnoid and~     piameninges, covering brain. It is often associated with concurrent intracranial injury~     component. Individuals at higher risk for tSAH are those who are at higher risk for blunt~     head trauma. This includes adolescents, low-income individuals, men, and individuals with a~     history of substance abuse. The investigators present study aims to investigate prognostic~     factors associated with the neurological outcome among patients of post traumatic SAH.~   "
114108|NCT02073877|"~     The Bone-Anchored Hearing Aid (Baha) system consists of an implanted part and sound~     processor. The system provides a hearing solution for a subgroup of patients who cannot~     sufficiently profit from conventional hearing aids. Disadvantageous are its high rate (up to~     40%) of associated peri-implant dermatitis. This research project is part of an attempt to~     reduce the amount of peri-implant dermatitis. Besides an attempt of Holgers to identify the~     skin flora in relation to infection around the abutment using a standard culture which~     yielded limited and no clinically relevant results, little is known about the microbiome on~     the abutment or its interaction with the commensal skin flora. Moreover, conventional~     cultures are not very sensitive in identifying bacteria. In 2010, Budding et al. introduced~     IS-pro. Is-pro is a novel 16S-23S rDNA interspace (IS)- region-based profiling method. This~     technology was devised to enable high-throughput molecular fingerprinting of microbioma.~     Since IS-pro is quick and relatively inexpensive, these environments can also be monitored~     over time by repeating the test. This paves the way for researching the microbiome on the~     abutment and it could enable clinically objective follow up of treatments in vivo using the~     human as a host. This technique allows researchers to even discover unknown, previously~     unidentified bacteria. Additionally, Scanning Electron Microscopy will be used to assess the~     spatial distribution and composition of bacteria on the abutment. The first step, using these~     techniques, is to determine the bacteria which inhabit the abutment also in relation to the~     surrounding skin. Additionally, the relationship with skin-implant infections and the effect~     of treatments will be monitored. Depending on these primary scientific results, a subsequent~     study will be devised to study (experimental) treatments in a randomized, controlled fashion.~      Objectives of the study:~        1. To identify the bacterial flora on the abutment in a phylum/species classification.~        2. To assess the relationships between the commensal skin flora and the flora on the~          abutment and to study if clinical signs of peri-implant skin infection and subsequent~          treatment are associated with a change in bacterial composition.~        3. To assess if there exists a relationship between skin hygiene and the transient skin~          flora.~   "
114109|NCT02073864|"~     A prospective, multi-center study to evaluate the neuro-embolic consequences of Transcatheter~     Aortic Valve Replacement (TAVR)~   "
114110|NCT02073851|"~     Pilot study enrolling up to 12 patients at a single investigational site in the Netherlands.~     Patients for TAVR will be enrolled to receive the Embolic Deflection Device throughout the~     duration of the TAVR procedure.~   "
114111|NCT02073838|"~     This is a research study of ribavirin which will be given in combination with vismodegib~     and/or decitabine. The purpose of this study is to see if patients respond to treatment when~     ribavirin is given with vismodegib alone or in combination with decitabine.~   "
114112|NCT02073825|"~     The purpose of this study is to adapt and pilot-test a web-based intervention intended to~     help concerned partners provide support to service members with alcohol misuse and to begin~     development of a service member module based on service member's input.~   "
114113|NCT02073812|"~     RPX7009(beta-lactamase inhibitor) is being studied in combination with a carbapenem (RPX2014)~     to treat bacterial infections, including those due to multi-drug resistant bacteria.~   "
114114|NCT02073799|"~     Recent literature indicated that postoperative storage symptoms after Photoselective~     vaporization of the prostate (PVP) or holmium laser enucleation of the prostate (HoLEP) were~     often reported and generally more common than after transurethral prostatectomy (TURP).~     However, almost all literature focused on postoperative urgency or dysuria immediately after~     PVP or HoLEP. Thus, there has been a scarcity of data on serial changes of storage symptoms~     in the postoperative period after PVP or HoLEP and data on predicting factors that influence~     improvement in storage symptoms postoperatively. The aim of this study was to compare serial~     changes of postoperative storage symptoms between PVP and HoLEP, and to identify the~     predictors that influence improvement of storage symptoms postoperatively.~   "
114115|NCT02073786|"~     Lightwand is a useful alternative device for intubation but scooping movement can induce~     damage and microbleeding of oral mucosa, postoperative hoarseness,sore throat. Optiscope is~     rigid video stylet which has camera on distal tip of device. In many previous studies, rigid~     video stylet has proven advantages compared with other intubating devices.~   "
114116|NCT02073773|"~     The present proposal aims to assess whether a combined rehabilitation approach using virtual~     reality based therapy with motivational feedback, levodopa for pharmacotherapy and standard~     rehabilitative occupational therapy and physiotherapy will lead to signifcantly better~     outcomes for stroke recovery.~      It is a randomised controlled trial with blinding of the assessors only. It will be preceeded~     by a Phase 1 pilot trial of the VR physiotherapy and standard therapy only. Recruited~     in-patient rehabilitation ward patients who have recently suffered stroke will be randomized,~     through a computer-based random number generator, to either one of two treatment arms:~        1. Control occupational therapy + pharmacotherapy for 2 weeks~        2. Assisted Virtual-Reality physiotherapy + pharmacotherapy for 2 weeks~   "
114117|NCT02073760|"~     The investigators will conduct qualitative interviews of hospital personnel regarding HAI~     prevention practices, and use coded data from these interviews to assist in developing~     standardized practices.~   "
114118|NCT02073747|"~     Empirical data from physician observation indicates an increase in serum lactate in acute~     asthmatic patients being treated with inhaled albuterol therapy.~      It is not clear if this increased serum lactate is in response to a physiological response to~     the asthmatic process or from the albuterol treatment.~      This study is designed to determine if administration of inhaled albuterol increases serum~     lactate in healthy subjects.~   "
114119|NCT02073734|"~     The investigators hypothesize that preoperative administration of 8 mg IV dexamethasone will~     benefit patients' perceived quality of recovery after surgery.~   "
114120|NCT02073721|"~     The use of electrical stimulation to reduce urinary incontinence in men undergoing~     prostatectomy exercises of the pelvic floor muscles (MAPs)~   "
114121|NCT02073708|"~     One out of ten adults and up to 20 % of children in Northern Europe are diagnosed with~     asthma. Patients with onset of disease in childhood and patients with adult-onset asthma have~     in common that their symptoms can be aggravated by exposures in the workplace. Work~     exacerbated asthma (WEA) is defined as worsening of asthma due to conditions at work and is~     common with a median prevalence of 22 %. However, additional research is needed to improve~     the understanding of the risk factors, mechanisms and outcomes of WEA. Studies of difference~     in response to exposures between subgroups of asthma patients may provide new insight also~     into the phenotypic heterogeneity of asthma.~      The primary aim of the study is to estimate the incidence rate of asthma in relation to age,~     sex, socioeconomic factors and occupational exposures in a prospective study. Recently, data~     on respiratory symptoms and physician diagnosed asthma has been collected from 16.300~     inhabitants of Telemark County (baseline study). A random sample from the baseline sample of~     1000 asthma cases and 1000 controls will be asked to participate in a medical examination in~     which blood pressure, lung function and Fraction of exhaled nitric oxide (FeNO) will be~     measured. In addition, blood samples will be collected form analysis of inflammatory markers~     and gene sequencing. The case-control study will be repeated after five years and ten years,~     if founded (5- and 10-year follow-up).~   "
114122|NCT02073695|"~     Research question:~      Do patients using a neutral rotation brace post surgery have improved functional outcome and~     external rotation of the shoulder compared to current best practice using a polysling holding~     the proximal humerus in internal rotation?~      Primary objectives:~      To compare post-operative functional outcome scores obtained at 6 weeks, 9 weeks, 3 months~     and 1 year. (Scores at 6 weeks and 3 months in clinical review and postal scores at 9 weeks~     and 1 year) between patients held in neutral versus current standard rotation. These will be~     compared to scores taken pre-operatively.~      Benefits:~      There may be no extra benefits to patients from this trial however the results from the trial~     will help improve treatment for future patients at this hospital, and others across the~     country.~      Risks/disadvantages:~      The operation is the same in both groups studied, the study is investigating the use of the~     two different slings. The post-operative treatment is also the same, and all patients on the~     trial will receive the same amount of physiotherapy. It isn't anticipated that there will be~     any additional risk from this trial.~   "
114123|NCT02073682|"~     Edoxaban will be similar to dalteparin in preventing recurrence of acute VTE following an~     initial index event in cancer subjects.~   "
114124|NCT02073669|"~     The aim of study is to evaluate the prevalence of latent TB in second generation immigrants~     from countries with high incidence of tuberculosis (above 20 of 100,000) compare to the~     control native Israelis without a family member who was born in a country with high incidence~     of tuberculosis. Using study questionnaire IGRA and tuberculin skin test the investigators~     expect that the second generation immigrants group will have more positive IGRA test than the~     control native group.~   "
114125|NCT02073656|"~     This study will evaluate the antiviral efficacy, safety, and tolerability of~     ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for 12 weeks in~     hepatitis C virus (HCV) treatment-naive and treatment-experienced (including treatment~     intolerant) participants with chronic genotype 1 or 4 HCV infection who are co-infected with~     HIV-1.~      Participants who experience confirmed post-treatment virologic failure (relapse) at or before~     Posttreatment Week 24 may be eligible to be enrolled in the Retreatment Substudy to receive~     LDV/SOF plus ribavirin (RBV) for 24 weeks.~   "
114126|NCT02073643|"~     This project examines behavioral and household characteristics associated with food~     purchasing patterns.~   "
114138|NCT02073487|"~     Purpose: The purpose of this study is to evaluate the Pathological Complete Response (pCR) of~     the breast when trastuzumab emtansine (TDM-1) plus Lapatinib plus Abraxane is combined in~     newly diagnosed HER2 positive breast cancer.~      This is a randomized, open label Phase II neo-adjuvant study comparing the efficacy of~     neoadjuvant Trastuzumab Emtansine (TDM1) plus lapatinib follow by Abraxane, versus~     trastuzumab (herceptin) plus Pertuzumab follow by paclitaxel.~   "
114139|NCT02073474|"~     The purpose of this registry is to monitor safety outcomes of patients who are receiving~     Sativex® for Multiple Sclerosis (MS) spasticity and for off-label indications in the United~     Kingdom (UK), Germany and Sweden.~   "
114127|NCT02073630|"~     Dystonia, a disabling disease with uncontrolled movement disorders was considered to be a~     manifestation of basal ganglia dysfunction, yet there is accumulating evidence from animal~     and human experiments that the cerebellum plays a prominent role in the pathophysiology of~     dystonia. Our recent results suggest a deficient cerebellar sensory encoding in dystonia,~     resulting in a decoupling of the motor component from the afferent information flow resulting~     from changes in the environment. An overall loss of gabaergic-mediated inhibition is at the~     forefront in dynamic changes in neural circuitry described in dystonia. In the mature brain~     gabaergic control the generation of temporal synchronies and oscillations in the~     glutamatergic neurons. Taken these all together with the results of a pilot experiment, the~     investigators hypothesize that deficient synchronies in the fast gamma range are one of the~     key mechanisms leading to abnormal communication inside the cerebello-cortical network in~     dystonia. The investigators aim first to demonstrate it by means of MEG (Magneto~     encepholography) recordings allowing to reconstruct the spatio-temporal dynamics of gamma~     oscillations in the nodes of the cerebello-cortical network. The investigators then aim to~     re-establish (if lost) or boost (if decreased) the defective synchronies by applying to the~     cerebellum at high gamma frequency a non invasive transcranial alternative current~     stimulation.~   "
114128|NCT02073617|"~     The American College of Cardiology/American Heart Association guidelines place symptomatic~     severe Aortic Stenosis as a class I indication for aortic valve replacement. With the~     recently approved Edwards-Sapien TAVR device and the ongoing investigations using the~     CoreValve TAVR device, patients ineligible or at high risk for open-heart surgery are now~     eligible to undergo TAVR.~      Patients selected for TAVR undergo an EKG-gated cardiac Multislice CTA to evaluate aortic~     valve anatomy and aortic root dimensions for device sizing, as well as coronary angiography~     to define coronary anatomy. Both tests utilize contrast media to visualize anatomy, which may~     result in contrast-induced nephropathy in anywhere from 7.5% to more than 50% of patients~     depending on associated clinical risk factors.~      There is a need to consolidate this pre-operative testing whenever possible, and with~     real-time 3-dimensional visualization of aortic valve and root anatomy using DynaCT cardiac~     acquisition in the cath lab angiography suite during the coronary angiography, there may be a~     benefit with reduced contrast load (20 to 35cc for DynaCT, 100cc for CTA).~      We would like to make a comparison of aortic valve and root measurements using CTA and DynaCT~     to affirm the accuracy of DynaCT vs the CTA gold standard.~   "
114129|NCT02073604|"~     The aim of the project is to study the role of secondary motor area (more precisely the~     supplementary motor area, or SMA) during unimanual and bimanual voluntary movements~     externally (cue) or internally (subject's choice) triggered. In that view, we will study 3~     experimental groups :~        -  a group of healthy volunteers (control group)~        -  the same group of healthy volunteers after a transient inactivation of the SMA (by the~          aim of repetitive trans cranial magnetic stimulation or TMS)~        -  a group of patients suffering from congenital mirror movements who are suspected to~          present a dysfunction of the SMA (according to our previous results) In each of these~          groups, by the aim of a serial reaction time task, we will study the influence of a SMA~          stimulation on the excitability of the primary motor cortex (M1) during the preparation~          of a voluntary movement (unimanual or bimanual). This will allow us to assess the~          communication between the SMA and M1 during movement preparation. Using the same task in~          functional imagery, we will study the activation's pattern of primary and secondary~          motor areas during movement preparation. This multimodal approach should allow us to~          better understand the synergistic functioning of these different structures involved in~          movement preparation. An other interesting aspect will be to determine the role of these~          structures in movement lateralization. Eventually, our results might allow us to precise~          to role of the motor preparation's dysfunction in the genesis of congenital mirror~          movements.~      In the first place, this study aims at a better understanding of the cerebral physiology of~     movement preparation (which is not well known) using the mirror movements paradigm as a~     dysfunction model (according to our previous results). According to our hypothesis, there is~     a strong link between the SMA and M1 during movement preparation. This hypothesis will be~     assessed by the use of the same experimental task with combined neurophysiological and~     neuroimaging approaches, thus increasing the validity of the results obtained.~      A secondary aim of this protocol is to precise the role of motor planning dysfunction in~     patients with congenital mirror movements. A better understanding of the mechanisms~     responsible for this condition is necessary in a medium-term therapeutic prospect.~   "
114130|NCT02073591|"~     This is a prospective, open label, single arm, and observational and multicenter study to~     assess the correlation between PEST and SCORAD scores in the management of AD with the~     Ceradan® regimen.~   "
114131|NCT02073578|"~     This is a pilot study for a new endoscopic treatment of achalasia. Up to 25 patients will be~     recruited for this trial, with the intent to treat 20 patients.~   "
114132|NCT02073565|"~     This is a multi-center, single-blind, randomized, active-controlled, clinical trial in~     Percutaneous Coronary Intervention [PCI] subjects. Subjects will be randomized to receive the~     Combo stent as the investigational treatment arm or an EES as the active-control arm.~   "
114133|NCT02073552|"~     The purpose of the study is to assess whether a low volume polyethylene glycol (PEG) plus~     ascorbic acid based bowel preparation for colonoscopy is not inferior to a large volume~     polyethylene glycol preparation in subjects with past history of poor bowel preparation~   "
114134|NCT02073539|"~     Chest compression (CC) feedback devices are used to perform CC measurements effectively and~     accurately on patients in hospital beds. However, these devices do not take account of the~     compression of the mattress, which results in overestimation of CC depth. This study is the~     validation study to demonstrate that a new method using one accelerometer(U-cpr) is useful to~     overcome this limitation and thus measure compression depth more accurately when performing~     cardiopulmonary resuscitation (CPR) on patients.~   "
114135|NCT02073526|"~     Drug serum concentrations will be measured at several time-points for inflammatory disease~     patients treated with anti-TNF agents. The purpose is to determine which patients that will~     clinically benefit from either discontinue treatment, adjusting the dose, switch to another~     anti-TNF agent or a different class of medication.~   "
114136|NCT02073513|"~     BACKROUNDS: Thumb in palm deformity restricts hand function by prevent somatosensory input in~     the children with cerebral palsy who have spasticity in their hands.~      OBJECTİVES: To investigate the effects of thenar palmar kinesiotape application with and~     without pressure on hand function in children with cerebral palsy. METHOD: 45 children were~     randomly allocated to one of the thenar taping groups either with or without pressure or to~     the control group. Nine hole peg test and nine parts puzzle test were used to measure hand~     function. The two study groups were evaluated initially, with taping 20 minutes later and 20~     minutes after taping was removed.~   "
114137|NCT02073500|"~     The aim of this study is to identify biomarkers of disease recurrence and prognosis to~     optimize patient selection for treatment with cytoreductive surgery (CRS) with hyperthermic~     intraperitoneal chemotherapy (HIPEC), and through animal models to explore different~     treatment strategies for peritoneal surface malignancies (PSM).~   "
114140|NCT02073461|"~     This study is to assess the efficacy and safety of two concentrations of CD1579 (2.5% and 5%)~     versus vehicle in the treatment of acne vulgaris in the Japanese patients.~   "
114142|NCT02073435|"~     Living donor liver transplantation (LDLT), involves complex systems and processes of care~     that are particularly vulnerable to medical errors and preventable complications. This~     ancillary study of the Adult-to-Adult Living Liver Transplantation Cohort Study (A2ALL) will~     focus on conducting a proactive, systematic, and comprehensive assessment of the~     vulnerabilities in the systems and process of LDLT care to reduce medical errors and~     preventable complications thereby improving the safety of LDLT care. This project will~     address an important gap in the knowledge needed to achieve high quality and safe LDLT care~     of patients by developing a process to: 1) proactively, systematically and comprehensively~     identify areas of vulnerabilities in LDLT care that can result in medical errors, 2) design~     and implement solutions to mitigate these weaknesses, and 3) evaluate the effectiveness of~     these solutions to improve the safety of LDLT care by measuring clinical and process outcomes~     before and after solution implementation across four A2ALL participating transplant centers~   "
114143|NCT02073422|"~     BACKGROUND: Non-ST-segment elevation myocardial infarction (NSTEMI) is the commonest type of~     acute coronary syndrome (ACS) and has a poor long-term prognosis. Guidewire-based coronary~     pressure measurement of the myocardial fractional flow reserve (FFR) is validated for~     measuring the severity of a coronary lesion narrowing in patients with stable angina. FFR~     measurement in patients with a recent ACS has theoretical limitations and is not fully~     validated.~      AIM: To prospectively assess heart muscle blood flow and injury with guide-wire based methods~     at the time of the clinically-indicated angiogram and compare these results with those from a~     stress perfusion MRI scan in medically-stabilised NSTEMI..~      HYPOTHESIS: 1) FFR measured invasively will correspond closely with findings from stress~     perfusion MRI, 2) MRI will provide clinically-relevant information on heart muscle injury,~     function and salvage, 3) Guidewire-derived measurements of coronary microvascular function~     will be associated with the MRI findings.~      DESIGN: The MRI study will be performed in patients who give informed consent in the~     FAMOUS-NSTEMI clinical trial (NCT registration 01764334). All of the clinical data for these~     participants will be available to link with the MRI results.~   "
114144|NCT02073409|"~     Isolation of nontuberculous mycobacteria (NTM) from the sputum of individuals with CF is an~     increasingly common finding, and the lack of an evidenced-based approach to the diagnosis of~     NTM disease has been identified as one of the greatest unmet needs within the CF community.~     Current evidence predicts that the prevalence of NTM will remain relatively high in the CF~     population. Approaches to NTM disease diagnosis differ widely between centers. This study is~     observational and follows current best practices. The study will help standardize the~     diagnosis and collect relevant data associated with the diagnosis of NTM disease to build a~     framework for future therapeutic trials.~   "
114145|NCT02073396|"~     Patients with coronary artery disease (CAD) and atrial fibrillation (AF) are at increased~     risk of stroke and heart attack. Such events are usually caused by increased stickiness of~     the blood causing a blood clot to block the artery (thrombus) in the heart or the brain. The~     aim of this study is to assess the stickiness of the blood (global thrombotic status) in~     patients with CAD and AF at baseline and after clinical stabilisation to see how disease~     state and clinical treatments affect the stickiness of the blood (thrombotic status). This~     will be a single centre study. Patients diagnosed with CAD or AF will have a blood sample~     taken at baseline and after clinical stabilisation. Blood stickiness will be tested with the~     Global Thrombosis Test. The results will be evaluated to assess the effect of disease process~     and clinical state on blood stickiness to gain further understanding of this condition and~     form the basis for future studies aimed at identifying patients who are at high risk of~     future cardiovascular events, based on increased blood stickiness.~   "
114146|NCT02073383|"~     The brachial plexus block is an anesthetic technique often used for surgical procedures of~     the upper limb. The brachial plexus block through the axilla (BPVA) is one of the techniques~     most commonly used to obtain regional anesthesia of the upper limbs, being performed by~     anesthesia of the terminal branches of the brachial plexus, which would be the ulnar, median,~     radial and musculocutaneous nerves. With the aid of ultrasound , two techniques can be used~     to perform the BPVA . The first , known as multiple puncture technique , the local anesthetic~     is deposited around each nerve that want to block . This technique is most commonly used to~     perform the BPVA . The second technique , known as 2 injections , local anesthetic is~     deposited below the axillary artery and around the musculocutaneous nerve . This technique~     has been proposed to try to reduce the execution time of anesthesia . Studies actually show~     that the technique of 2 injections showed less time to perform the block, with the same~     success rate. However, the technique of 2 injections showed a longer latency and higher rate~     of vascular puncture . (14) In order to perform a procedure with shorter execution time ,~     without changing the latency, success rate and ensuring patient safety , the investigators~     designed this protocol to evaluate three techniques for performing the ultrasound- guided~     axillary brachial plexus block.~   "
114147|NCT02073370|"~     Sarcopenia related mobility dysfunction was a preventable presentation in transitional~     variation of frailty. However, the definition, associated risk factors, clinical course and~     outcome of sarcopenia in Taiwanese older adults are still under-clarified and need for~     further study.~   "
114148|NCT02073357|"~     General anaesthesia is a reversible drug-induced coma. Too little can result in patients~     being partially conscious during surgery; too much can slow recovery after surgery. There is~     a range of drug doses that can be used and some anesthesiologists use more than others. There~     is no convincing evidence that any particular dose within the usual range is better.~     Consequently, there are no guidelines on the best depth of anaesthesia. This study will~     determine whether general anesthetic concentrations at the low end of the usual range are~     better than those at the high end.~      Participants will randomly be assigned to lighter or deeper general anesthesia. The first day~     after surgery, two short questionnaires about recovery and memories of the surgery will be~     completed. During the rest of the participant's hospital stay, a survey about how one feels~     will be completed.~      There will be two telephone contacts after discharge from the hospital. One month after~     surgery three questionnaires will be completed about performing daily tasks, how you feel and~     memories of the surgery. Then one year after surgery pain will be assessed.~   "
115592|NCT02054442|"~     The investigators will perform a randomized phase II study to investigate if the addition of~     cetuximab to MTX is beneficial for the patient. Because no data on this combination are~     available the investigators will start with a phase Ib study to investigate the feasibility~     of the schedule.~   "
114149|NCT02073344|"~     The purpose of this study is to investigate the effect of beginning a renal replacement~     therapy on fluid overload and its consequence on the severity of obstructive sleep apnea, in~     patients with end stage chronic kidney disease. It aims further to investigate the~     relationship between overhydration, nocturnal rostral fluid shift and the severity of sleep~     apnea.~   "
114150|NCT02073331|"~     The objective of the study is to actively gather additional information on the use of~     CorMatrix ECM for pericardial reconstruction.~   "
114151|NCT02073318|"~     Purpose -To investigate whether older adults with dementia who have balance and gait problems~     can improve their balance and gait function after an individualized 4-week tasks-oriented~     balance training with sensory manipulation.~      Hypothesis~      -There is significant difference of Timed Up and Go Test, Berg Balance Scale, walking speed,~     30-s chair-stand test, Chair sit-and-reach test and Barthel Index between dementia patients~     who received tasks-oriented balance training and those didn't receive after 4-weeks training~     and one month follow-up.~   "
114152|NCT02073305|"~     The purpose of this study is to prospectively evaluate the impact of sleep apnea on the~     cardiovascular morbidity and mortality of patients with end-stage renal disease.~   "
114153|NCT02073292|"~     Nerves in your body transmit signals to and from your brain and the cells in your body. In~     the event of an injury or disease, these nerves transmit pain. Sometimes, when an injury~     doesn't heal, chronic pain can develop. One way to treat chronic pain is to interrupt these~     pain signals. One method of doing this is to use Radio frequency ablation (RFA).~      Radio frequency ablation (RFA) is a medical procedure in which heat is generated from high~     frequency electrical current in order to lesion (burn) nervous tissue. Radiofrequency~     ablation is used to treat many conditions in several areas of the body including cardiac~     (heart) as well as chronic pain. Probes (needles) are inserted into the body to a specific~     location and the electrical current is passed through these needles. This electrical current~     creates heat in your body and forms small lesions or burns in a specific place. Doctors will~     use tools, such as fluoroscopy (x-rays) and injections to locate the specific nerves that are~     transmitting pain and then use the electrical current to destroy those nerves.~      Equipment used include generator, built in nerve stimulator, different needles and probes and~     water cooling system in case of the cooled RFA.~      There are several types of probes or needles that are used to transmit energy and create~     lesions. This study is going to compare 2 types - standard radiofrequency and 'cooled'~     radiofrequency. The only difference is that the 'cooled' radiofrequency probes have water~     running through the probe tip, which keeps the tip cool and allows a larger lesion to be~     made. Since the doctor can't actually see the nerve he is trying to target, the larger lesion~     should theoretically improve his chances of hitting it. The 'cooling' of the water also~     allows the temperatures to be lower than what is needed for standard RF. In this study, the~     investigators would like to compare the differences between standard RFA (90°C) and cooled~     RFA (60°C) ablation techniques and determine if one is better for pain relief.~      All of the probes that are used to perform radiofrequency ablation are FDA approved and are~     commonly used to treat patients with chronic back pain.~      Participating in the study involves being randomly assigned to received either standard or~     cooled RFA. The procedure for both standard and cooled RFA is basically the same. The only~     difference is with standard RFA, the doctor may perform up to 2 lesions, instead of 1 if they~     are using cooled RFA.~      Both study groups will receive local anesthetic prior to procedure. The treating doctor will~     use a machine called a C-Arm to take x-rays. These x-rays will guide the doctor to be sure~     the probes are in the right place. Once the probe placement is confirmed, the doctor will~     turn on the generator and create the lesion. This process will be repeated depending on how~     many lesions need to be created.~      After the procedure there will be follow up visits at 1, 3 and 6 months. Level of pain,~     health and recovery information will be collected.~   "
114154|NCT02073279|"~     The objective of this study is to evaluate the efficacy, safety, pharmacodynamic,~     pharmacokinetic and immunogenic profiles of SA237 in patients with NMO and NMOSD~   "
114155|NCT02073266|"~     The primary purpose of the study was to compare the macular hole closure and visual acuity~     gain following vitrectomy using SF6 gas tamponade with 7 days of face-down positioning versus~     C3F8 gas tamponade with 14 days of face-down positioning.~      The secondary purpose was to report, in each group, the cumulative incidence of cataract~     development 1 year following macular hole surgery and the proportion of complications (*).~      ((*) hypertony, hypotony, retinal tear, retinal detachment and endophthalmitis) This~     prospective randomized study examined a 3 year period. The first patient was included in~     January 2010 and the last in November 2011. The 12-month follow-up spread out from March 2011~     to December 2012. The first group included 31 patients who had undergone macular hole surgery~     using SF6 gas and who were advised to stay in face-down position for 7 days postoperatively~     (SF6 group). These patients were compared to 28 patients who had undergone macular hole~     surgery with C3F8 gas and who were advised to maintain a face-down position for 14 days.~     Patients in both groups underwent vitrectomy, internal limiting membrane peeling, and~     fluid-gas exchange using either SF6 or C3F8.~      Preoperative data included the characterization of the hole with Optical Coherence Tomography~     (OCT), the best correct visual acuity (VA) recorded in number of letters using the Early~     Treatment Diabetic Retinopathy Study (ETDRS) chart, classification of the cataract according~     to the LOCS III and the intraocular pressure IOP. Postoperative data included OCT~     confirmation of the closure at 6 weeks and 1 year, 1 year's best corrected VA recorded in~     number of letters (EDTRS chart) and determination of cataract development and extraction as~     needed.~   "
114156|NCT02073253|"~     Introduction: Noninvasive ventilation (NIV) has been used to minimize such impairment and~     increasing ventilator reserve in individuals with heart failure. Aim: To analyze~     thoracoabdominal kinematics (TK) in individuals with HF associated to cardiomegaly after~     using NIV. Methods: A randomized crossover clinical trial with allocation consisted of two~     experimental phases: NIV and control, 7 days apart of each other. During NIV phase, 30~     minutes of bi-level ventilation was performed. Any type of ventilator support was offered~     during control phase. Optoeletronic plethismography was performed to asses TK.~   "
114157|NCT02073240|"~     Study Design: Stratified, matched, cluster-randomized, controlled trial~      Unit of Randomization: Healthcare facility~      Study Duration: 3 years; prevalence of latent Tuberculosis infection (LTBI) in healthcare~     workers (HCWs) will be at measured at baseline, and LTBI incidence will be measured among~     susceptible HCWs at 12 and 24 months. Secondary outcomes will be measures at 0~     (pre-intervention) 6, 12, 18, and 24 months. In year three, results will be analyzed and~     disseminated.~      Study Components: Assessment of institutional safety culture; observations/audits of~     Tuberculosis (TB) patient flow (wait times) and HCW TB infection control (IC) practices;~     documentation of time intervals for processing sputum smears and initiation of TB treatment;~     facility assessments; random allocation and implementation of enhanced Tuberculosis infection~     control (TB IC) package; testing of HCWs to determine LTBI at 0, 12, 24 months; cost~     evaluation of intervention.~      Sample Size: For the cluster randomized design, we estimate that 11 clusters per group will~     allow for 77 percent (%) power to identify a 30% reduction in LTBI incidence in the~     intervention vs. control clusters. This assumes LTBI incidence 5% per year in the control~     group, design effect for clustering of 2.0, and cluster size of 300 (average 600 HCW per~     cluster with 50% LTBI prevalence at baseline).~   "
115637|NCT02053857|"~     To test whether a ready-to-use therapeutic food (RUTF) enriched with polyunsaturated fatty~     acids (RUTF-P) is as effective for the treatment of severe acute malnutrition (SAM) as~     standard RUTF.~   "
114158|NCT02073227|"~     The purpose of this study is to assess the bioequivalence of the fixed dose combination (two~     components combined in one tablet) of canagliflozin and metformin extended release (XR)~     tablet (dose of 2 X 150 mg/1,000 mg) with respect to the individual components of~     canagliflozin (1 x 300 mg) and metformin XR tablet (4 x 500 mg) in healthy fed participants.~   "
114159|NCT02073214|"~     The purpose of this study was to evaluate the safety of a probiotic foodstuff and its~     influence on emergence and development of natural intestinal flora and the clinical status of~     premature very low birth weight neonates. The study was also intended to investigate~     reduction of colonisation by pathogenic bacteria and to estimate the incidence of~     gastrointestinal disorders.~      Probotic bacteria contained in the investigational product administered directly after birth~     are beneficial for the development of normal gut microflora and can prevent or significantly~     limit gastrointestinal colonisation by pathogenic bacteria and the development of pathogenic~     flora in a hospital setting. Permanent colonisation with commensal flora in very early life~     improves gastrointestinal function in premature neonates by reducing the onset of or by~     decreasing the severity of the signs and symptoms of feeding intolerance and generalised~     bacterial infections, including sepsis and necrotizing enterocolitis.~   "
114160|NCT02073201|"~     A primary focus of the University of Florida (UF) Claude D. Pepper Older Americans~     Independence Center (OAIC) is to build a comprehensive understanding of the causes and~     consequences of declining physical function and disability development among older adults. To~     date investigators have largely focused on sarcopenia, the age-related decline in skeletal~     muscle mass and strength, as the primary contributor to physical decline. However, recent~     findings indicate that changes in the central and/or peripheral nervous systems may play a~     larger role than previously thought in the development of functional limitations. These~     fields hold extensive promise for identifying novel contributors to age-related functional~     decline. Therefore, the overarching aim of this project is to develop the ability of RC1 to~     assess novel neural contributors to mobility and overall physical function. Importantly, the~     development of these techniques will provide the RC1 with the tools to evaluate the potential~     involvement of the central and peripheral nervous systems in age-related functional decline~     and disablement. The primary aim of this project is to develop techniques for quantifying~     peripheral motor unit number and size as well as spinal cord integrity.~   "
114161|NCT02073188|"~     The purpose of this study is to demonstrate the superiority of iBGstar as a component of the~     diabetes treatment vs. traditional blood glucose self-monitoring system for improving~     glycemic control after 6 months in young patients with type 1 diabetes. The study is intended~     also to demonstrate the superiority of iBGStar as a component of the diabetes treatment vs.~     usual blood glucose self-monitoring system for improving the compliance to self monitoring of~     blood glucose after 6 months.~   "
114162|NCT02073175|"~     The purpose of this study is to determine whether a dietary supplement (DS) is effective in~     protecting against sad mood in postpartum.~   "
114163|NCT02073162|"~     Physicians differ in their approaches to surgical fluid therapy, with some preferring higher~     volumes and others lower volumes. Each approach has potential advantages and disadvantages.~     Currently, there is no compelling evidence that one approach is better than the other. This~     study tests whether giving a volume on the low end of the usual amount (restrictive~     management) has a different rate of complications compared to a volume on the high end of~     the usual amount (liberal management). This study will compare liberal and restrictive~     fluid management to determine their effects on major complications after abdominal surgery.~      Those who take part in the study will be visited five times before and after surgery in the~     hospital. Once discharged from the hospital, participants will be called 4 times on the~     telephone.~      Preadmission Clinic/Preoperative Visit~        -  Sign the consent document~        -  Have blood drawn for standard preoperative tests (standard of care)~        -  Have an electrocardiogram (standard of care)~        -  Complete a questionnaire on disability (research)~      Day of Surgery~        -  Have blood drawn if not already done during the first visit (standard of care)~        -  Have an electrocardiogram if not already done during the first visit (standard of care)~        -  Be randomly assigned to either restrictive or liberal fluid management (research)~      Post-op Day 1~        -  Have an electrocardiogram done (research)~        -  Have blood drawn for standard tests (standard of care)~        -  Have a wound inspection, if there is a change of dressing (standard of care)~        -  Complete a questionnaire about your recovery (research)~      Post-op Day 3~        -  Have blood drawn for standard tests (standard of care) and c-reactive protein, which can~          indicate infection (for research).~        -  Have a wound inspection, if there is a change of dressing (standard of care)~        -  Complete a questionnaire about your recovery (research)~      Day of Discharge~        -  Have a wound inspection, if there is a change of dressing (standard of care)~           30-Day Follow-up Phone Call~        -  Complete a questionnaire about your recovery (research)~        -  Complete a questionnaire about disability (research)~           3 Month, 6-Month, and 12-Month Follow-up Phone Calls~        -  Complete a questionnaire about disability (research)~   "
114164|NCT02073149|"~     This study will determine whether the haemoglobin response to daily home fortification for 30~     days with 3mg iron as NaFeEDTA is non-inferior to 12.5 mg iron as encapsulated ferrous~     fumarate.~   "
114165|NCT02073136|"~     Patients with chronic kidney disease struggle to eliminate phosphate as the renal function~     deteriorates, which results in accumulation of phosphate in the body. This has been shown to~     increase the patients' risk of cardiovascular disease and death. Even with dialysis treatment~     the patients cannot excrete enough phosphate to reach phosphate balance. The patients are~     therefore recommended a very restrictive diet when they reach the dialysis stage. It is~     therefore important to find ways to prevent such accumulation of phosphate in the body as~     early in the disease process as possible, but without compromising the nutritional status.~     Because phosphate occurs naturally in many of our foods, such as meat, fish and dairy~     products, it is difficult to reduce the intake of phosphate, without also reducing the intake~     of energy and protein. Over the past couple of years there has been an increased focus on the~     use of phosphate containing additives in the food industry. A reduction in the intake of~     phosphorus containing additives may reduce the accumulation of phosphate in the body. This~     can be achieved by decreasing the intake of processed food products. Because it is also very~     time consuming and inconvenient for the patient to keep these strict diets, the patients have~     a reasonable claim to know which effects can be achieved by such diets. This will therefore~     seek to be further explored in the following study. The study is conducted as a randomised~     crossover trial in predialysis patients stage 3-4.~   "
114166|NCT02073123|"~     To evaluate the preliminary efficacy of the established dose of indoximod in combination with~     immune checkpoint inhibition as measured by the best overall response rate (ORR) (complete~     response (CR) + partial response (PR))across both standard of care agents administered~     sequentially in patients with unresectable stage III or stage IV melanoma~   "
114302|NCT02071342|"~     The aim of our study is to evaluate the clinical outcomes at 30 days and 1 year (cardiac~     death, myocardial infarction, target lesion revascularization (TLR), target vessel~     revascularization (TVR), thrombosis of the device in patients who are undergoing angioplasty~     in myocardial infarction and in which bioabsorbable stent was implanted (BVS). Additionally,~     we will evaluate the acute recoil after implantation of bioabsorbable stents. A 24 months~     follow-up , by means of coronary angiography accompanied by QCA and assessment with~     intracoronary ultrasound (IVUS) and VH (virtual histology) is scheduled.~   "
114167|NCT02073110|"~     Data from the American Cancer Society shows a 70% increase in incidence of kidney and renal~     pelvis cancer between 2000 and 2010. This increase is attributed to small renal masses (SRM)~     that are incidentally discovered by abdominal radiological imaging. However, 30% of resected~     SRMs appear benign on histological examination. Conventional biopsy is currently used to~     provide pathological information prior to resection. However, its non-diagnostic value is~     high, up to 33% in SRMs, showing the need for diagnostic improvement.~      The investigators have shown that optical biopsy (OB) can differentiate malignant from benign~     tissue and tumor subtypes. However, translation to the clinic requires a phase 2 clinical~     study. The investigators will use an OB probe that can be combined with a needle puncture~     during classical biopsy procedures, additionally providing real time micro-scale images~     containing quantitative information about tissue properties. The investigators are convinced~     that OB will greatly improve the diagnosis of renal tumor pathology.~   "
114168|NCT02073097|"~     This phase I/II trial studies the side effects and best dose of carfilzomib when given~     together with rituximab and combination chemotherapy and to see how well they work in~     treating patients with diffuse large B-cell lymphoma. Carfilzomib may stop the growth of~     cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies,~     such as rituximab, can block cancer growth by finding cancer cells and helping kill them.~     Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either~     by killing the cells or by stopping them from dividing. It is not known if carfilzomib in~     combination with R-CHOP is better or worse than R-CHOP alone in treating patients with~     diffuse large b-cell lymphoma.~   "
114169|NCT02073084|"~     The purpose of this study is to determine the effects of K-877 on ECG parameters with a focus~     on cardiac repolarization compared with placebo in healthy adult subjects.~   "
114170|NCT02073071|"~     This is a two stage open-label, single-arm, multicenter and observational study.~   "
114171|NCT02073058|"~     The purpose of this study is to demonstrate point accuracy of the Abbott Sensor Based Glucose~     Monitoring (GM) System interstitial glucose results against Reader capillary Blood Glucose~     (BG) reference using the Consensus Error Grid. During the course of the wear duration, the~     subject is required to test fingerstick glucose measurement at least eight (8) times a day~     for capillary reference glucose measurements and three in-clinic visits of a maximum 13 hours~     each for venous reference glucose measurements. With every reference measurement, the subject~     or study staff will perform a measurement on the System.~   "
114172|NCT02073045|"~     This pilot clinical trial studies intensive education in increasing understanding of~     lymphedema in patients with breast cancer undergoing surgery. Lymphedema is the build-up of~     fluids in the arm (or other extremity) after surgery. Providing written educational handouts~     and verbal education on the risk factors and symptoms of lymphedema may improve patients'~     ability to identify symptoms of lymphedema after surgery.~   "
114173|NCT02073032|"~     The main objective of this observational survey was to determine the incidence rate of~     refeeding phenomena (RFF) (defined as any decline in p-phosphate) and RFS (defined as any~     decline in p-phosphate with additional development of any of the following clinical symptoms:~     oedema, confusion, dyspnoea, hypotension, arrhythmia, seizures) among recently admitted or~     referred HNC patients to the Department of Otorhinolaryngology for surgery. The second~     objective was to determine if informations at admittance could identify HNC patients at high~     risk of developing RFF and RFS.~   "
114174|NCT02073019|"~     The purpose of this study is to determine whether BL-8040 is safe, tolerable and effective in~     the mobilization of Hematopoietic Stem Cells (HSC) in healthy volunteers~   "
114175|NCT02073006|"~     Constipation is common in the general population, especially in women and in the elderly.~     Hard stool is a complaint often associated with constipation, which suggests that stool~     softening would provide a major benefit in the strategy of treatment.~      This investigative fibre product is primarily a soluble dietary fibre with added probiotics~     and a prebiotic. It is not digested in the small intestine and partly remains undigested by~     bacteria in the gut. Also, as probiotics are believed to help restore a healthy gut flora,~     reduce pH, assist with digestion of food and reduce gaseous by-products they may aid the~     improvement of intestinal motility.~      The objective of this study is to assess if this investigative, fibre product effects the~     number of bowel movements per week and if this in turn impacts quality of life and symptoms~     of constipation.~   "
114176|NCT02072993|"~     This is a first time in human study to assess the safety and tolerability of AZD1979~     following oral administration of single ascending doses in healthy male volunteers.~     Pharmacokinetics (what the body does to the drug) parameters will also be assessed as~     secondary objectives.~   "
114177|NCT02072980|"~     The primary objective of the study is to demonstrate that the lubricity of DAILIES TOTAL1®~     (DT1) lenses after 16 hours of wear is equivalent to the lubricity of unworn DT1 lenses.~   "
114178|NCT02072967|"~     Prospective multicenter observational non-interventional study to assess routine clinical~     practice of Bendamustine use in the second line therapy of relapsed or refractory indolent~     B-cell non-Hodgkin's lymphoma~   "
114179|NCT02072954|"~     To compare and evaluate the oral bioavailability of Asenapine Sublingual Tablets, 10 mg~     manufactured by AMNEAL PHARMACEUTICALS, USA with SAPHRIS® (asenapine) sublingual tablets, 10~     mg.~   "
114180|NCT02072941|"~     In partnership with patients, caregivers, advocacy groups and clinicians, the investigators~     plan to:~      Aim 1: Adapt and refine PREPARE in Spanish through cognitive interviews with Spanish-speaking~     Latinos and stakeholders.~      Aim 2: Conduct a randomized clinical trial (RCT) to compare the efficacy of PREPARE plus a~     previously-tested, easy-to-read- AD (intervention) versus the AD alone (control) to:~      2a. Engage older Spanish-speaking Latinos in multiple ACP behaviors (i.e., identify and~     discuss wishes with surrogates and clinicians and complete ADs) measured by self-report,~     chart review, surrogate reports, and~      2b. Direct observation.~      2c. Improve self-efficacy and satisfaction with medical decision making.~      2d. Determine whether PREPARE efficacy varies by literacy, decision control preferences, and~     clinician-patient language concordance.~      Aim 3: Disseminate PREPARE with input from patients, surrogates, and stakeholders.~   "
114181|NCT02072928|"~     This study will evaluate the impact of BOTOX® treatment on anticholinergic drug use in~     patients with urinary incontinence from Neurogenic Detrusor Overactivity (NDO) due to spinal~     injury or Multiple Sclerosis (MS) who are prescribed BOTOX® as standard of care in clinical~     practice.~   "
114183|NCT02072902|"~     This is a large nationwide population study, with 10 year follow-up, of the effect of~     diabetes, metabolic control and a large number of glucose-lowering medications, on total and~     site-specific cancer incidence and survival.~      The study is based on electronic medical records from the largest Israeli health maintenance~     organization in Israel, Clalit Health Services. 2,301,990 insurees age 21 years old or above~     at study entry, January 2002 will be included. Four study groups will be established~     according to the prevalence of diabetes and/or cancer on that date: neither diabetes nor~     cancer; prevalent diabetes but not cancer; prevalent cancer but not diabetes; both diabetes~     and cancer prevalence. Subjects free of diabetes at study entry will be followed for diabetes~     incidence, and all four groups will be followed until December 2012 for study outcomes. The~     cohort data file will be linked to the Israel National Cancer Registry for cancer morbidity.~      We will compare, after adjustment, all and site-specific cancer rates between individuals~     with and without diabetes; and investigate if metabolic control, as indicated by HbA1c and~     blood glucose levels, is related to cancer risk. Using time-dependent Cox proportionate~     hazard models, we will then evaluate differences in outcomes that associate with the use of~     one or a combination of glucose-lowering treatments, while stratifying by those who were~     already diagnosed with diabetes at study entry, and those diagnosed during follow-up. Data~     for a large number of potential confounding variables, including BMI, plasma glucose, HbA1c,~     hormone replacement therapy and comorbidities will help mitigate allocation bias. The~     accessibility and uniformity of the healthcare provided by Clalit Health Services, as well as~     data on cancer screening tests, will minimize the risk of surveillance bias.~   "
114184|NCT02072889|"~     Measurements will be made between the internal jugular vein and the carotid artery using an~     ultrasound machine as the subjects is asked to move and position his or her neck in various~     positions.~      It is hypothesized that by movements of the neck the investigators can maximize the distance~     between the internal jugular vein and the carotid artery to decrease inadvertent cannulation~     of the carotid artery to improve patient safety~   "
114185|NCT02072876|"~     The incidence of stroke has increased by 100% in the last four decades in developing~     countries like Pakistan. Intracranial atherosclerotic disease (ICAD) is the most frequent~     causative subtype of ischemic stroke in the world including Pakistan. ICAD is progressive~     narrowing of the arteries at the base of the brain due to atherosclerosis. After a stroke~     from ICAD, recurrence rate is highest in any sub-type of stroke, up to 28% with limited~     therapeutic options. Therefore, it is imperative to delineate the determinants of~     asymptomatic ICAD prior to stroke. Investigators hypothesized that there is at least a 20%~     difference in the proportion of clinical, life-style (dietary, physical activity, obesity,~     smoking and stress/depression), and socio-economic predictors of asymptomatic ICAD than those~     with no ICAD.~   "
114186|NCT02072863|"~     The purpose of Phase 1b of the study is to determine the maximum tolerated dose (MTD) of~     oprozomib in combination with melphalan and prednisone (OMP).~      The purpose of Phase 2 of the study is to estimate the overall response rate (ORR) and~     complete response rate (CRR) of the OMP combination.~   "
114187|NCT02072850|"~     Heart imaging with magnetic resonance imaging (MRI) provides detailed insights into heart~     function and injury. The nature and significance of heart injury after a heart attack is~     incompletely understood. We propose a 'natural history' study of heart attack injury using~     contemporary MRI methods. In a large hospital in the West of Scotland, heart attack patients~     will be invited to have at least two MRI scans and also continue with life-long follow-up.~     The results from the MRI scans will be assessed with all of the other clinical information~     obtained at the time of the heart attack and during follow-up. The results of our study~     should provide new insights into heart attack injury and these results should help improve~     how heart attack patients should be treated.~   "
114188|NCT02072837|"~     In this study, we studied lipoprotein abnormalities-related variables as risk factors for the~     development of cardiovascular disease in patients on renal replacement therapies.We studied~     96 dialyzed patients, 62 males and 34 females, on mean age 62.1 years old and 24 healthy~     controls.We concluded that metabolic acidosis activating the inflammation and lipoprotein~     oxidation influences the dyslipidemia and cardiovascular morbidity of patients on renal~     replacement therapies.Dialysis adequacy was positively associated to cardioprotective~     HDL.Peritoneal dialysis holds a better acidosis level and lower oxidized lipids than~     hemodialysis modalities.~   "
114189|NCT02072824|"~     This study is designed to evaluate the effectiveness of 2 doses of pregabalin to reduce~     seizure frequency as an add on therapy in pediatric subjects 1 month to <4 years of age with~     refractory partial onset seizures. It is hypothesized that both doses of pregabalin will~     demonstrate superior efficacy when compared to placebo by reducing the partial onset seizure~     frequency and that pregabalin will be safe and well tolerated.~   "
114190|NCT02072811|"~     In view of the diversity of the biology of acute myeloid leukemia (AML) therapy in individual~     patients must be individualized. One of the tools for this is molecular-cytogenetic~     stratification. It divides patients into five categories (prognostic groups): Favorable,~     Intermediate-1, Intermediate-2, Adverse and Very adverse risk. After remission proceedings~     are tailored depending on prognostic determined groups.~      Research of PALG group in the application in the second line regimen CLAG and CLAG-M proved~     high effectiveness of this treatment with low toxicity. Considering experience of PALG~     groups, it seems that the use of the schema CLAG early as the second induction therapy is a~     viable treatment option.~   "
114202|NCT02072655|"~     In the early 2000s , professional and patient organizations are mobilizing to highlight the~     psychosocial impact of cancer disease , not only during but also after the acute phase.~      In 2003, the government launched the Cancer Plan I reinforced in December 2011 by the Cancer~     Plan II whose objectives include :  Develop a personalized care taking into account the pain~     and psychological and social support  and  increase opportunities for patients to benefit~     from supportive care and promote the professional integration .~      This study aims to show that beyond the immediate benefits of the social aesthetic cares in~     hospital (direct soothing, improving the quality of the skin injured by chemotherapy ,~     feeling of escape ... ), these treatments can also affect quality of life for patients during~     and after hospitalization. They also may have an impact on the maintenance of social and / or~     professional satisfactory throughout the planned chemotherapy aplastic period .~   "
114191|NCT02072798|"~     Background Women undergoing Caesarean Section (CS) have an increased risk of postpartum~     infections compared to women undergoing vaginal delivery. In Denmark the incidence of post-CS~     infections is 7-10%. The most common infections are endometritis, Urinary tract infections~     (UTI) and wound infections (WI).~      Prophylactic antibiotics are effective in preventing postoperative infections and national~     guidelines recommend that antibiotics should be administered as a single dose immediately~     before surgical incision. CS is an exception to this pre-incision administration approach.~     National guidelines recommend administration of antibiotics after umbilical cord clamping to~     avoid exposure of the child to antibiotics before birth. Recent studies of antibiotic~     prophylaxis for CS suggest that prophylactic antibiotics administered before incision~     compared to after umbilical cord clamping may reduce post-CS infections by up to 50%. Two~     Cochrane reviews from 2012 criticize these types of studies for lack of data for outcomes on~     the baby and on late infection in the mother.~      At birth, all mammals must rapidly adapt to intake of complex milk nutrients via the gut and~     simultaneously tolerate the invasion of billions of microbes. This requires rapid maturation~     of the digestive and immune functions to avoid gut disorders and infections. Full-term,~     breast-fed infants normally adapt well, but factors such as caesarean birth, high hygiene~     levels, antibiotics treatment and formula feeding may inhibit immune development both short~     and long term. Birth by caesarean section in high-hygiene hospital environments, and~     widespread use of antibiotics, are factors that reduce gut microbiota density and diversity~     in the newborn for some time after birth. On the other hand, high-hygiene environments and~     antibiotics are essential tools to combat infections, especially for the weakest newborn~     infants.~      This pilot study will be a feasibility study to the original study, which examines the effect~     of change in timing of prophylactic antibiotics on the rate of post-CS infections~     (endometritis, UTI and WI). The pilot study focus on antibiotic and changes in the gut~     microbiota of newborn infants. The feasibility study will only include pregnant women in~     Odense with a body mass index below 30, and planned cesarean section.~   "
114192|NCT02072785|"~     The purpose of this study is to determine whether vincristine sulfate liposome could reduce~     less peripheral neuropathy than vincristine sulfate,and be as effective as vincristine~     sulfate in adults with Naïve Acute Lymphoblastic Leukemia.~   "
114193|NCT02072772|"~     The purpose of this study is to determine whether Positively Smoke Free group therapy is more~     effective at promoting cessation than standard care.~   "
114194|NCT02072759|"~     Insulin resistant subjects and type 2 diabetic patients are characterized by a decreased~     metabolic flexibility: a reduced capability to switch from fat oxidation in the basal state~     to carbohydrate oxidation in the insulin-stimulated state. This metabolic inflexibility is an~     early hallmark in the development of diabetes. Recent evidence suggests that a low carnitine~     availability may limit acetylcarnitine formation, thereby reducing metabolic flexibility. We~     propose to test the hypothesis that metabolic inflexibility in pre-diabetic subjects and~     diabetic patients is due to a reduced capacity to form acetylcarnitines.~   "
114195|NCT02072746|"~     The purpose of this study is to determine if zinc therapy: (1) strengthens your intestine's~     defensive barrier preventing damaging substances from reaching your liver, (2) decreases~     liver injury (inflammation, oxidative stress, cell death) and scarring, and (3) improves your~     liver-related health. Based on our preliminary animal data and other published reports, we~     expect zinc therapy to achieve all of these goals. Zinc is affordable, available over the~     counter or by prescription, and has an excellent safety profile. Positive results from this~     study will show that zinc is a significant therapy for millions of Americans with alcoholic~     liver disease.~   "
114196|NCT02072733|"~     A Feasibility study Geriatric assessment applied to patients with cancer of the head and~     neck, lung cancer, upper gastrointestinal cancer or colo-rectal cancer. On the day of~     planning the oncologic treatment Comprehensive Geriatric Assessment (CGA) will be offered to~     patients aged 70 years and up. Based on the CGA a tailored multidisciplinary intervention is~     planned with the patients. The study aims 1) to investigate if it is feasible to offer CGA to~     all elderly (+70 years) patients with the relevant cancer diagnoses as mentioned above in The~     Central Denmark Region (Region Midt) , 2) to estimate the proportion of frail, vulnerable or~     fit elderly cancer patients, 3) to investigate the impact of a CGA on the planned oncologic~     treatment intensity, and 4) to investigate the ability of CGA to predict complications to~     cancer treatment within a three months period.~   "
114197|NCT02072720|"~     The main question of this study is if and when VEGF (vascular endothelial growth factor)~     expression in the tumor is upregulated during chemoradiation and if bevacizumab inhibits~     subsequent vessel growth in the tumor.~        -  Therefore the first aim of this study is to identify the time point of induction of VEGF~          in the tumor tissue of esophagus carcinoma during chemoradiation (after 1,2,3 or 4 weeks~          of chemoradiation).~        -  If we identify increased expression of VEGF at a certain time point, our second aim is~          to determine if we can inhibit the subsequent tumor vessel growth by administration of~          bevacizumab.~   "
114198|NCT02072707|"~     The investigators hypothesized that combined endocardial and epicardial VT ablation using~     contact sensor irrigated catheter is safe and achieves a lower recurrence rate than~     endocardial only ablation in ischemic and non-ischemic patients, for this the investigators~     will randomize 20 patients in two groups, one with endocardial only ablation and other with~     combined endocardial and epicardial ablation.~   "
114199|NCT02072694|"~     This study evaluates the hypothesis that a meal constituted of only glucose produces~     differences in the brain blood flow in people with obesity that are not observed in people~     without obesity. These changes, at least in part, could explain the mechanisms involved in~     maintenance or development of obesity.~   "
114200|NCT02072681|"~     The objective of this study is to determine the 90-day outcomes of mild and rapidly improving~     ischemic stroke.~   "
114201|NCT02072668|"~     The primary study hypothesis is that inhibition of factor Xa with rivaroxaban will reduce~     inflammation, coagulation and endothelial cell activation, and improve microvascular blood~     flow in patients with sickle cell disease (SCD) during the non-crisis, steady state. To test~     this hypothesis, this study will evaluate the effects of rivaroxaban on:~        -  plasma markers of inflammation;~        -  plasma markers of endothelial activation;~        -  plasma markers of thrombin generation; and~        -  microvascular blood flow assessed using laser Doppler velocimetry (LDV) of~          post-occlusive reactive hyperemia (PORH).~      In a cross-over design, subjects will receive rivaroxaban 20 mg/day and placebo for 4 weeks~     each, separated by a 2-week washout phase.~   "
114255|NCT02071953|"~     The intent of this study is to evaluate the clinical performance of an experimental dental~     bonding agent for use with dental restorative composites with and without pretreatment of the~     tooth dentin and enamel using phosphoric acid etching.~   "
114303|NCT02071329|"~     The purpose of this study is to assess the safety, tolerability, efficacy, and immunogenicity~     of an influenza A vaccine (vaccine: FP-01.1), as compared to placebo, in healthy volunteers~     following a dose of influenza A virus.~   "
114203|NCT02072642|"~     Parkinson's disease, a degenerative disorder of the dopaminergic system, combines motor~     symptoms but also non-motor, such as depression, sleep disorders and circadian rhythms and~     impaired cognitive functions. Difficulties in balancing the dopaminergic treatment of these~     patients emphasizes the need to find effective adjuvant therapies. Light therapy (LT)~     represents one such innovative therapeutic approach. Although light has an obvious to visual~     pathways within the brain, today it is known to additionally exert non-visual effects~     throughout the body. Recently our team has shown that non-visual, non-circadian light plays a~     major role in the regulation of sleep, as well as cognitive brain function in general. The~     retina, the primary conduit for the transmission of light information is weakened or thinned~     in Parkinson's patients. The dopamine system is known to enhance the processing of light~     information and intraocular injection of L-dopa in animal models of Parkinson's disease, can~     reverse associated motor symptoms. This allows for the possibility that LT would strengthen~     the dopaminergic tone in the central nervous system. However, to this date its effectiveness~     for alleviating Parkinson's symptoms has only been suggested by two studies, both poorly~     controlled. Thus, through the convergence of basic and clinical data, a study examining the~     effect of LT directly in people Parkinson's disease symptoms, whilst controlling for the~     effects on sleep, circadian system, mood, and cognitive functioning, is of extreme~     importance. With this information our hope is to determine if these polymorphisms allow for a~     predictive model of response to LT treatment.~   "
114204|NCT02072629|"~     This study will assess how the current VHV (VHV=CHW, community health worker) scope can be~     expanded to include iCCM and if such group interventions can provide improved access to~     treatment for children.~      In rural SW Uganda, can iCCM provided by lay volunteers, increase the proportion of children~     with diarrhoea receiving ORS/Zn, ARI receiving anti-biotics, and fever/malaria receiving~     anti-malarials?~   "
114205|NCT02072616|"~     Histological proof is a crucial and necessary step for appropriate care in oncology. In the~     case of pancreatic cancer, histological proof from pathological analysis of the surgical~     specimen is very rare due to the limited number (15-20 %) of localized tumor accessible to~     surgical resection. In most cases, invasive endoscopic explorations are necessary for~     histological diagnosis before deciding of the most appropriate treatment (palliative~     chemotherapy or radiochemotherapy). The endoscopic ultrasound with fine needle aspiration~     (EUS-FNA) is currently considered as the first-line endoscopic procedure for the cytological~     diagnosis of solid pancreatic tumors. The technique is performed under general anesthesia~     with sensitivity for the diagnosis of adenocarcinoma of 80% in case of a single procedure and~     92% in situations where three different procedures are required. EUS-FNA has to be performed~     by a physician properly trained for this type of interventional endoscopy. Some severe~     complications may occur but are relatively rare in expert centers (bleeding, perforation,~     complications of general anesthesia ...).~      Diagnostic alternative approach is biological with research in the peripheral blood of~     markers of tumor disease. It is possible to detect indirect markers which are molecules~     produced by tumor tissue (eg CA19.9) and direct markers which reflect the presence of tumor~     biological material (circulating tumor cells (CTCs) or circulating tumor DNA).~      The value of detection of CTCs is not determined for the diagnostic and therapeutic~     management of pancreatic cancer. Indeed, no study has evaluated the diagnosis performance of~     circulating markers with EUS-FNA, the reference method for the diagnosis of unresectable~     forms.~   "
114206|NCT02072603|"~     The purpose of this study is to determine the effectiveness of the HITSystem in maximizing~     early infant diagnosis (EID) service utilization for HIV-exposed infants and early~     antiretroviral therapy (ART) initiation for infants diagnosed with HIV.~   "
114207|NCT02072590|"~     The main purpose of this study is to improve the diagnostics of celiac disease and reduce the~     need for invasive endoscopic studies in children. Further, the investigators aim to~     investigate the natural history and risk of complications in children with celiac disease or~     gluten sensitivity and to create a large scientific database.~   "
114208|NCT02072577|"~     Supervise dental conditions and teach the procedure of oral hygiene are the responsibility of~     the nurse. Patients on chemotherapy have risk for oral and systemic changes factors. The~     investigators will evaluate the cognitive and procedural knowledge about oral hygiene and the~     relevance of the learning experience importance.~   "
114209|NCT02072564|"~     The purpose of this study is study the possible relationship between various lifestyle habits~     of men and women (age, body mass index, diet, exercise, alcohol, tobacco, coffee, etc..) and~     live birth rate after in vitro fertilization-intracytoplasmatic injection (IVF-ICSI).~   "
114210|NCT02072551|"~     The main objective of this study is to evaluate Beta cells in patients with a neonotal~     diabetes linked to a genetic abnormality Metabolic caracteristics will described using a~     transversal cohort study.~   "
114211|NCT02072538|"~     New high-sensitivity cardiac troponin (hs-cTn) assays allow earlier detection of acute~     myocardial infarction (AMI). Furthermore, elevated values were associated with an increased~     risk of recurrent AMI or death. Therefore, guidelines recommend an early invasive strategy in~     patients with elevated admission values and kinetic changes. Other criteria for an early~     invasive strategy include a GRACE risk score >140 points or other cardiovascular risk~     factors. Hs-cTn assays allow discrimination of patients at very low and high risk. Studies~     confirmed safety of early discharge protocols in patients with unstable angina (UAP). The aim~     of this study is to 1) confirm the safety of early discharge without invasive strategy in~     patients with UAP and to 2) review the optimal timing of stress-testing. Therefore, patients~     are being randomized into 2 groups with pre-discharge and early post-discharge~     stress-testing. Endpoints are major adverse cardiovascular events within 30 and 90 days.~   "
114212|NCT02072525|"~     The purpose of this study is to collect serum samples for use as quality control samples in~     GSK assays. The serum samples need to include samples with low, medium and high antibody~     titers/concentrations, which cover the assay range.~   "
114213|NCT02072512|"~     The purpose of this study is to assess the efficacy of goserelin plus fulvestrant 500mg~     comparing with goserelin plus anastrozole as first line endocrine therapy for pre- and~     perimenopausal HR+ advanced breast cancer.~   "
114214|NCT02072499|"~     The purpose of this study is to compare safety and efficacy of Green Light PVP~     (Photoselective Vaporisation of the Prostate) compared to open prostatectomy when treating~     benign prostatic hyperplasia (BPH).~   "
114215|NCT02072486|"~     This clinical trial studies sorafenib tosylate in treating patients with liver cancer that~     cannot be removed by surgery. Sorafenib tosylate may block some of the enzymes needed for~     tumor cell growth. Blocking these enzymes may also help the immune system work better.~     Granzyme B is a biomarker that can be used to measure how well the immune system is working.~     A biomarker is a biological molecule found in blood, other body fluids, or tissues that is a~     sign of a normal or abnormal process, or of a condition or disease. Studying granzyme B~     levels in patients receiving sorafenib tosylate may help doctors learn more about the effects~     of sorafenib tosylate on the immune system and may help to predict how well sorafenib~     tosylate will work in treating patients with liver cancer.~   "
114216|NCT02072473|"~     This proposal aims to evaluate safety and efficacy aspects of a new protocol for AVNRT~     ablation, using a stepwise anatomical approach.~      The investigators hypothesize that the use of a standardized electro-anatomical guided~     strategy, using a sequential approach as follows:~        1. Right-side postero-septal tricuspid annulus~        2. Coronary sinus~        3. Left-side postero-septal mitral annulus~      For slow pathway AVNRT ablation is safe and efficient, increasing the chance of a successful~     ablation in difficult cases, while reducing the need of re-do procedures and the risk for~     high-degree atrio-ventricular block.~      The investigators aim to define and implement a new standardized protocol for AVNRT ablation~     while at the same time assessing the efficacy and safety of coronary sinus and left-side~     approaches for slow-pathway ablation.~   "
114217|NCT02072460|"~     The present project aims at describing how vestibular signals contribute to the multisensory~     mechanisms of bodily self-consciousness.~      There is a large body of data regarding the sensory and neural mechanisms of~     self-consciousness, but most studies have so far demonstrated the contribution of visual,~     tactile and proprioceptive signals to bodily self-consciousness. Thus, most studies have~     neglected the contribution of the vestibular system, a major sensory system for spatial and~     bodily representations. The vestibular system is sensitive to head motions in space and head~     inclinations with respect to gravity and it should therefore contribute significantly to~     several bodily experiences. This contribution should be put under neuroscientific scrutiny.~     We believe that the current neuroscientific models of bodily self-consciousness will be~     incomplete until they incorporate the contribution of vestibular signals.~      The present project specifically aims at testing the hypothesis according to which vestibular~     signals significantly influence bodily self-consciousness, in particular first-person and~     third-person perspective taking and the internal body models (i.e. the body schema and body~     image). The present project also aims at describing how cortical vestibular processing is~     modified during experimental changes of perspective taking and viewpoint. In addition, the~     present project will describe whether vestibular disorders change performances in~     third-person perspective taking tasks and modify internal body models. This should help~     understanding bodily symptoms in vestibular-defective patients. To this end, we will combine~     approaches from psychophysics and electrophysiology (electromyography,~     electroencephalography) in healthy volunteers and behavioral approached in patients with~     vestibular disorders.~      These studies should further the understanding of how the brain processes vestibular signals,~     which is to date poorly understood. In addition, the outcome of the present project should~     help understanding the multiple and complex symptoms reported by patients with vestibular~     diseases, and should therefore improve their treatment.~   "
114218|NCT02072447|"~     This study aims to determine the absolute bioavailability of YH4808 using simultaneous oral~     therapeutic- and [14C]-labeled intravenous microdoses.~   "
114219|NCT02072434|"~     The purpose of this study is to compare edoxaban (investigational drug) with warfarin and~     enoxaparin, to see if it is safe and effective in preventing stroke and other blood clot~     complications in subjects with atrial fibrillation whose doctors plan to treat them with an~     electrical cardioversion. It is expected that 284 sites will recruit 2200 subjects from North~     America, EU, Russia, Ukraine and Israel. Participants will be randomly allocated to receive~     either treatment with edoxaban, or treatment with warfarin, plus enoxaparin if required.~     Participants will have an equal chance of receiving either treatment. Participants will be in~     the study for a maximum of 82 days. Study procedures will include physical examinations,~     vital signs (pulse and sitting blood pressure), ECG (electrocardiogram), finger prick blood~     clotting tests, blood samples, urine samples and completion of Quality of Life~     questionnaires.~      The study is expected to show that edoxaban will provide comparable incidence rates for~     efficacy to warfarin plus enoxaparin, the current standard treatment, and will be at least as~     safe as warfarin for the incidence rate for bleeding~   "
114220|NCT02072421|"~     The primary objective of the Post-Randomization Phase Cohort Study is to continue to assess~     the safety of non-emergency PCI performed at hospitals without cardiac surgery on-site in~     patients with myocardial ischemia (other than ST-segment elevation myocardial infarction~     [STEMI]).~   "
114221|NCT02072408|"~     The purpose of this study is to evaluate the efficacy and safety of aflibercept for treatment~     of polypoidal choroidal vasculopathy without active polyp.~   "
114222|NCT02072395|"~     The purpose of the study is to assess the efficacy of a hybrid laparoscopic surgical~     procedure for treatment of morbid obesity, Gastric Plication (G)) and Gastric Banding.~   "
114223|NCT02072382|"~     The proposed study is to evaluate the possible effect of metformin on arterial pressure by~     24h-ambulatory blood pressure monitory (24h-ABPM).~   "
114224|NCT02072369|"~     The purpose of this study is to investigate the benefits of incorporating an actuated,~     EMG-controlled glove into occupational therapy of the hand.~   "
114225|NCT02072356|"~     This clinical trial studies radiolabeled glass beads (yttrium Y 90 glass microspheres) in~     treating patients with unresectable hepatocellular carcinoma. Internal radiation therapy uses~     radioactive material placed directly into or near a tumor to kill tumor cells. Using~     radiolabeled glass beads to kill tumor cells may be an effective treatment for liver cancer.~   "
114226|NCT02072343|"~     Capnometer has been used to assess the success of intubation and the quality of~     cardiopulmonary resuscitation. However, capnometers can malfunction under the conditions such~     as pulmonary edema and hemorrhage due to the vulnerability of capnometers for water.~     Investigators hypothesized that the use of 10cm catheter mount will reduce the malfunction of~     capnometers under the conditions of water.~   "
114227|NCT02072330|"~     The objective of this study is to compare the efficacy and safety of combined administration~     of TAK-536CCB (Fix-dose combination of Azilsartan and Amlodipine) and Hydrochlorothiazide~     (HCTZ) with those of TAK-536CCB in patients with Grade I or II essential hypertension.~   "
114228|NCT02072317|"~     The purpose of this study is to evaluate and compare safety and effectiveness of Chemotherapy~     in Paclitaxel plus raltitrexed plug compare with taxol second-line treatment for advanced~     gastric cancer~   "
114229|NCT02072304|"~     The purpose of this study is to develope web-based cognitive behavioral therapy for Korean~     adoldescents who have a mild depression. And we will investigate whether web-based cognitive~     behavioral therapy is more effective than supportive psychotherapy for treating depressed~     adolescents. Our hypothesis is web- based cognitive behavioral is more effective than~     supportive psychotherapy~   "
114230|NCT02072291|"~     The main factors associated with pregnancy rate in In Vitro Fertilization (IVF) treatment are~     embryo quality and the uterine ability to accept the embryo for implantation. This ability is~     influenced by uterine contractions (UC), which change in pattern and direction during the~     menstrual cycle. An abnormal uterine contraction pattern can displace the embryo from the~     proper position in the uterine cavity towards the cervix or the fallopian tubes and as a~     result may decrease pregnancy rates and increase the risk of ectopic pregnancy. Indeed,~     previous studies demonstrated a negative correlation between uterine contraction rate and~     implantation/pregnancy rates. Suppression of uterine contractions during embryo transfer can~     be achieved by a large array of drugs, such as cyclo-oxygenase inhibitors, β2-adrenoreceptor~     agonists, calcium-channel blockers, phosphodiesterase inhibitors and oxytocin antagonists.~     The objective of this study is to evaluate the efficacy of Nifedipine administration in~     reducing uterine contractility during IVF-frozen embryo transfer (FET) treatment.~   "
114231|NCT02072278|"~     To explore a neurophysiological marker (electroencephalography) of cognitive effect of~     vortioxetine~   "
114232|NCT02072265|"~     Permanently implantable venous ports (Port-A) is very important to patients receiving~     chemotherapy. It not only provides a reliable route to administrate intravenous drugs, and it~     also requires minimal care when it is not in use. However, catheter related blood stream~     infection(CRBSI) is one of the serious complications of Port-A. The diagnosis of CRBSI relies~     on limited tools, including blood culture or symptoms and signs of active infection. In the~     stage of CRBSI, Port-A removal is necessary and pose the risk for the patients to re-implant~     the Port-A. Thus, it is crucial to early detect the infection and give appropriate treatment.~     Among the pathogens, some pathogens are related to skin contaminants. Before systemic~     spreading, these pathogens may colonize or cause minor infection subcutaneously. This~     investigation is to utilize a non-invasive dual spectrum infrared imaging system to evaluate~     the Port-A wound and to detect the infection.~      Aim: 1. To build the database of infra-red thermal images of Port-A wound healing. 2. To~     investigate the thermal images of skin contamination related CRBSI and to compare with the~     thermal images of the CRBSI of unknown foci~   "
114233|NCT02072252|"~     The purpose of this study is to determine whether a mobile phone application (app) for~     symptoms of depression and anxiety is practical and acceptable to young men who are attracted~     to men, and whether it reduces their anxiety and depressive symptoms. The investigators will~     also evaluate whether reductions in symptoms are maintained over a 10 week follow-up period~     after young men complete the mobile phone intervention.~   "
114234|NCT02072239|"~     The purpose of this study is to determine whether or not the Angioshield device can be safely~     applied to support saphenous vein grafts used in standard coronary bypass surgery.~   "
114235|NCT02072226|"~     PRISMS is a double-blind, multicenter, randomized, Phase IIIb study to evaluate the efficacy~     and safety of intravenous (IV) alteplase in participants with mild acute ischemic strokes~     that do not appear to be clearly disabling. Participants will be randomized in a 1:1 ratio to~     receive within 3 hours of last known well time either 1) one dose of IV alteplase and one~     dose of oral aspirin placebo or 2) one dose of IV alteplase placebo and one dose of oral~     aspirin 325 milligrams (mg).~   "
114236|NCT02072213|"~     Study to Investigate The Pharmacokinetics of GL2702 GLARS-NF1 and Omix Ocas® in Healthy Male~     Volunteers~   "
114237|NCT02072200|"~     This study is multicenter, Ph IV, single arm, interventional study to assess relative~     reduction of morning stiffness of Lodotra® in Rheumatoid Arthritis patients.Study medication~     will start after study visit at baseline (week 0, visit 1) and follow-up visit will be after~     2, 6 and 12 weeks after treatment (visit 2,3,4).~   "
114238|NCT02072187|"~     Low levels of vitamin D have been associated with depression. This study will test if a~     vitamin D supplement is helpful in patients with depression who have not found relief with~     the use of anti-depressant medication. Participants will continue to take their medication~     plus vitamin D or placebo for 8 weeks. The investigators will monitor their depression~     symptoms and the investigators think that the people taking vitamin D may have an improvement~     in their symptoms.~   "
114239|NCT02072174|"~     The purpose of this study is:~      • To obtain additional data on therapeutic efficacy of Anaferon for children in the treatment~     of influenza and acute respiratory viral infections in children~   "
114240|NCT02072161|"~     The purpose of this research study is to see how ETC-1002 is tolerated in the body and how~     ETC-1002 affects the levels of LDL-C (bad cholesterol) in patients receiving ongoing statin~     therapy.~   "
114241|NCT02072148|"~     In general, patients with Human Papilloma Virus Positive Oropharyngeal Squamous Cell~     Carcinoma (HPVOPC) are curable, young and will live for prolonged periods. They are at high~     risk for long-term toxicity and mortality from therapy. While the long-term consequences of~     chemotherapy and surgery for head and neck cancer are relatively constrained, high-dose~     radiotherapy (RT) and chemoradiotherapy (CRT) substantially impact on local tissues and organ~     function and result in a significant rate of late mortality and morbidity in patients.~     Studies are now being designed to reduce the impact of RT and CRT for patients.~      Patients with intermediate stage HPV positive oropharyngeal cancer will be screened for poor~     prognostic features and undergo robotic surgery. Patients in whom pathology demonstrates good~     prognosis features will then be followed without postoperative radiotherapy. Patients with~     subsequent recurrence will be treated with either surgery and postoperative radiotherapy or~     postoperative chemoradiotherapy alone. Patients with poor prognostic features (ECS, LVI, PNI)~     will receive reduced dose radiotherapy or chemoradiotherapy based on pathology. It is~     expected that over 50% of patients treated with surgery will have had a curative treatment~     and will avoid radiation therapy entirely and long-term survival will not be changed by~     withholding radiation therapy to good prognosis patients after surgery. There are exploratory~     biomarkers of risk of recurrence that will be collected and studied.~      There are currently few trials examining the role of de-escalation using surgery alone in~     intermediate and early T-stage HPV related disease. New surgical techniques have broadened~     the range of patients capable of achieving a complete resection and the functional outcomes~     in such patients are outstanding. Furthermore, the sensitivity of HPVOPC to chemotherapy and~     radiotherapy raise the possibility that delayed or salvage treatment in early stage patients~     would be highly effective, would result in similar survival outcomes and radiotherapy could~     be applied to a much smaller population then current standards call for. Looked at from a~     different perspective, the need for post-operative radiotherapy in this younger, HPV+ and~     more functional population has not been validated in clinical trials to date.~   "
114277|NCT02071667|"~     The purpose of this study is to see if a protein in blood, called periostin, can determine if~     patients have chronic sinusitis. This protein is in everyone's body, but the level of the~     protein may indicate certain conditions such as chronic sinusitis. The investigators are~     interested in testing levels of periostin to see if they are higher or lower than patients~     without chronic sinusitis, just as periostin is higher in patients with asthma. All patients~     enrolled in this study will have chronic sinusitis without asthma.~   "
114278|NCT02071654|"~     A prospective, non-randomized, multi-center clinical study of the Venus P-valve for the~     treatment of RVOT stenosis with pulmonary regurgitation after surgery of congenital heart~     defect.~   "
114242|NCT02072135|"~     This study involves a drug called Exparel that has been approved by the US Food and Drug~     Administration (FDA), for application directly to wound sites. EXPAREL® is a long acting pain~     reliever. It is being given in this study to see if it provides safe and effective pain~     relief after ankle surgery. Because it is a long acting drug, it may lessen pain relief for~     as much as 72 hours after surgery.~      EXPAREL® has not been approved by the FDA for administration by popliteal block, which is the~     method the study doctors will use to give the patients the drug. Giving the drug by popliteal~     block involves inserting a small tube in to the back of the knee to deliver the drug. The~     study doctors wish to determine if patients undergoing ankle surgery and receiving this drug~     have less pain and less need for narcotic medication.~   "
114243|NCT02072122|"~     The purpose of this study is to determine the relation between estrogen and progesterone~     levels, and between dryness of the eyes, in women during their fertile years.~   "
114244|NCT02072109|"~     Early initiation of enteral feeding, achievement of full enteral feeding and cessation of~     parenteral nutrition are extremely important in the very premature infant. This way it is~     possible to achieve good post-natal growth and developement while minimizing the metabolic~     and infectious complications of parenteral feeding.~      There isn't much information in literature regarding the impact of enteral feeding on~     intestinal blood flow and intestinal regional oxygenation in the preterm infant. There is~     also no consensus regarding the best regimen of delivering the enteral nutrition - bolus~     feeding or continuous feeding.~      The aim of our study is to compare the intestinal regional oxygenation before and after two~     feeding regimens - bolus feeding and continuous feeding - in clinically stable preterm~     infants born before 32 weeks gestation. The evaluations will be performed using NIRS~     technology (Near Infrared Spectroscopy).~      The study may help to assess which feeding regimen is gentler to the immature intestines~     (i.e. alters less the splanchnic blood flow and oxygenation) and therefore the preferred way~     to feed preterm infants.~   "
114245|NCT02072096|"~     The main purpose of this study is to compare the benefits and risks associated with the use~     of 2 treatment strategies to lower blood sugar in participants aged 65 and older with T2DM.~     One strategy is based on the use of oral and injectable medications that only reduce blood~     sugar (glucose) when it is high. The other strategy is based on non-glucose dependent agents.~     The trial will last up to 72 weeks for each participant.~   "
114246|NCT02072083|"~     The aim of this study is using intranasal dexmedetomidine versus intranasal~     midazolam-ketamine combination for premedication and preventing the oculocardiac reflex of~     pediatric patients undergoing strabismus surgery.~   "
114247|NCT02072070|"~     The purpose of this study is to determine whether TissueGene-C, an allogeneic human~     chondrocytes expressing Transforming Growth Factor(TGF)-b1, is effective and safe in patients~     with degenerative arthritis.~   "
114248|NCT02072057|"~     The aim of this study is to investigate the effects and safety of Ruxolitinib, a Janus kinase~     1 (JAK1) and Janus kinase 2 (JAK2) inhibitor for the treatment of tumor-associated cachexia~     in chronic wasting diseases.~   "
114249|NCT02072044|"~     Anlotibib (AL3818) is a kind of innovative medicines approved by State Food and Drug~     Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing~     Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with~     multi-targets, especially for VEGFR2、VEGFR3、PDGFRβ and c-Kit. It has the obvious resistance~     to new angiogenesis. The trial is to explore the efficacy and safety profile of Anlotinib in~     patients with advanced Renal Cell Carcinoma(RCC) that have failed to TKIs therapy.~   "
114250|NCT02072031|"~     Anlotibib (AL3818) is a kind of innovative medicines approved by State Food and Drug~     Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing~     Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with~     multi-targets, especially for VEGFR2、VEGFR3、PDGFRβ and c-Kit. It has the obvious resistance~     to new angiogenesis. The trial is to compare the efficacy and safety profile between~     Anlotinib and Sunitinib in patients with advanced Renal Cell Carcinoma(RCC).~   "
114251|NCT02072018|"~     Treatment of Peyronie's disease remains difficult. The purpose of this study is to test the~     safety and efficacy of a new compound to treat this disease.~   "
114252|NCT02072005|"~     The primary aim of this study is to conduct a 9-patient feasibility and acceptability study~     of mSMART (with future studies focusing on improved medication adherence). The sample will~     include daily smokers who are already taking a prescribed medication. There will be no change~     in any medication regimen in this study, and the sample will include smokers either with or~     without a psychiatric disorder. Subjects will be asked to use a smartphone application, or~     app (i.e. mSMART) that will provide information about their medication and when to take it.~     Along with smart phone, the participants will be asked to utilize an electronic pillbox (i.e.~     GlowCap) to further assist with medication compliance.~   "
114253|NCT02071979|"~     This study will examine differences in the process of wound-healing in patients treated with~     platelet rich plasma (a concentration of proteins derived from a patients own blood) applied~     to the wound as a gel; injected into the wound or surrounding tissue; or both; compared to~     patients treated with usual medical treatment . This study seeks to enroll patients who are~     18 or older with a non-healing skin wound that is at least 30 days old. Only patients with~     Diabetic Foot Ulcers, Venous Ulcers, or Pressure Ulcers will be included in the study.~   "
114254|NCT02071966|"~     The aim of the study is to learn more about the pathophysiology of acute coronary syndrome~     (ACS) and to evaluate the mechanisms responsible of the action and benefits of ticagrelor.~      Ticagrelor is an oral and reversible inhibitor of P2Y12 receptor. Few information is~     available about the action of ticagrelor on the molecules involved in thrombogenesis and~     platelets activation in ACS.~      The aim of this study is to evaluate the mechanisms of ticagrelor action in vivo.~      It was observed that patients with myocardial infarction have higher blood levels of~     microparticles than patients with unstable angina or stable angina.~      The investigators assumed that ticagrelor benefits are represented by a reduction of~     microparticle levels, a marker of endothelial dysfunction in patients with cardiovascular~     disease, and by a modification in microRNAs pattern, fragments of mRNA that have a regulatory~     action in various cellular processes (such as proliferation, differentiation, growth and~     cellular death) and represent new biomarkers in ACS.~   "
114256|NCT02071940|"~     KIT (receptor tyrosine kinase) mutations occur in 15% of acral and mucosal melanomas. PIANO~     is a single arm, phase II, open-label, multicentre study to evaluate the efficacy and safety~     (plus molecular basis of such effects) of the KIT inhibitor PLX3397 (developed by Plexxikon)~     in advanced KIT mutated acral and mucosal melanoma.~      In this trial a total of 24 patients (9 in the first stage and 15 in the second stage) will~     receive treatment over a 24 month recruitment period.~      Following consent and successful screening, patients will receive PLX3397 capsules 1000mg/day~     as monotherapy, and will remain on therapy as long as they are deriving clinical benefit.~     Patients will be seen every 4 weeks during treatment to monitor response and toxicity.~     Routine blood tests will be carried out at all visits and pharmacokinetics/pharmacodynamics~     sampling (1 x 8 milliliter(ml) whole blood sample) will be done pre-dose on Day 1 and Day 15,~     frozen and stored locally and sent to Plexxikon's vendor for central analysis at the end of~     the study. Imaging will be carried out every 12 weeks to monitor response. The first 9~     patients will also receive two [18F]-fluorodeoxyglucose (FDG) PET scans (baseline and at Day~     15).~      From specific named participating sites, 12 patients will provide additional (optional)~     consent to take part in translational research. 5 of these patients will have a fresh tumour~     biopsy taken at baseline, at day 15 and upon disease progression. The same 5 patients plus an~     additional 7 patients (to give a total of 12 patients) will also donate blood samples at~     baseline, 2 weeks, 12 weeks and on disease progression for the evaluation of circulating~     tumour cells and circulating free tumour DNA.~      All patients will be followed up every 6 months until death or for 12 months after the last~     patient has discontinued study treatment.~   "
114257|NCT02071927|"~     Many tumor cells, in contrast to normal cells, have been shown to require the amino acid~     glutamine to produce energy for growth and survival. To exploit the dependence of tumors on~     glutamine, CB-839, a potent and selective inhibitor of the first enzyme in glutamine~     utilization, glutaminase, will be tested in this Phase 1 study in patients with leukemia.~      This study is an open-label Phase 1 evaluation of CB-839 in subjects with leukemia. Part 1 is~     a dose escalation study to identify the recommended Phase 2 dose as a single agent and in~     combination with azacitidine. Patients enrolled into Part 2 will be treated with the~     recommended Phase 2 dose. As an extension of Part 2, patients with relapsed/ refractory or~     newly diagnosed AML will be treated with CB-839 in combination with azacitidine.~      All patients will be assessed for safety, pharmacokinetics (plasma concentration of drug),~     pharmacodynamics (inhibition of glutaminase), biomarkers (biochemical markers that may~     predict responsiveness in later studies), and tumor response.~   "
114258|NCT02071914|"~     This study is to evaluate the efficacy of CT-P27 measured by quantitative PCR viral load from~     nasopharyngeal mucosa, compared to placebo.~   "
114259|NCT02071901|"~     This phase II trial studies how well eltrombopag olamine works in improving the recovery of~     platelet counts in older patients with acute myeloid leukemia undergoing induction (the first~     treatment given for a disease) chemotherapy. Platelet counts recover more slowly in older~     patients, leading to risk of complications and the delay of post-remission therapy.~     Eltrombopag olamine may cause the body to make platelets after chemotherapy.~   "
114260|NCT02071888|"~     Many tumor cells, in contrast to normal cells, have been shown to require the amino acid~     glutamine to produce energy for growth and survival. To exploit the dependence of tumors on~     glutamine, CB-839, a potent and selective inhibitor of the first enzyme in glutamine~     utilization, glutaminase, will be tested in this Phase 1 study in patients with advanced~     hematologic malignancies.~      This study is an open-label Phase 1 evaluation of CB-839 in subjects with hematological~     tumors. Patients will receive CB-839 capsules orally two or three times daily. The study will~     be conducted in 2 parts. Part 1 is a dose escalation study to identify the recommended Phase~     2 dose and will enroll patients with advanced and/or treatment-refractory Non-Hodgkin's~     Lymphoma (NHL), Multiple Myeloma (MM), or Waldenström's macroglobulinemia (WM)~      In Part 2, all patients will receive the recommended Phase 2 dose. This part will enroll~     patients with advanced and/or treatment-refractory Non-Hodgkin's Lymphoma (NHL), Multiple~     Myeloma (MM), or Waldenström's macroglobulinemia (WM). All patients will be assessed for~     safety, pharmacokinetics (plasma concentration of drug), pharmacodynamics (inhibition of~     glutaminase), biomarkers (biochemical markers that may predict responsiveness in later~     studies), and tumor response.~      As an extension of Part 2, a cohort of patients with relapsed and refractory MM will be~     enrolled to receive low dose dexamethasone and CB-839. A second cohort of patients with~     relapsed or refractory disease following at least 2 prior treatment regimens will be enrolled~     to receive CB-839 in combination with standard-dose pomalidomide and low-dose dexamethasone~     to further evaluate this triple combination.~   "
114261|NCT02071875|"~     To determine the efficacy of using the Jan Medical NNW system as a diagnostic aid in~     detection of moderate and severe vasospasm for detection of vasospasm in patients with~     subarachnoid hemorrhage.~   "
114262|NCT02071862|"~     Many tumor cells, in contrast to normal cells, have been shown to require the amino acid~     glutamine to produce energy for growth and survival. To exploit the dependence of tumors on~     glutamine, CB-839, a potent and selective inhibitor of the first enzyme in glutamine~     utilization, glutaminase, will be tested in this Phase 1 study in patients with solid tumors.~      This study is an open-label Phase 1 evaluation of CB-839 in patients with advanced solid~     tumors. The study will be conducted in 2 parts. Part 1 is a dose escalation study enrolling~     patients with locally-advanced, metastatic and/or refractory solid tumors to receive CB-839~     capsules orally twice or three times daily.~      In Part 2, patients with each of the following diseases will be enrolled: A) Triple-Negative~     Breast Cancer, B) Non-Small Cell Lung Cancer (adenocarcinoma), C) Renal Cell Cancer, D)~     Mesothelioma, E) Fumarate hydratase (FH)-deficient tumors, F) Succinate dehydrogenase~     (SDH)-deficient gastrointestinal stromal tumors (GIST), G) SDH-deficient non-GIST tumors, H)~     tumors harboring mutations in isocitrate dehydrogenase-1 (IDH1) or IDH2, and I) cMyc mutation~     tumors.~      As an extension of Parts 1 & 2, patients will be treated with CB-839 in combination with~     standard chemotherapy. Combination groups include: Pac-CB, CBE, CB-Erl, CBD, and CB-Cabo.~     Pac-CB: patients with locally-advanced or metastatic TNBC will be treated with paclitaxel and~     CB-839. CBE: patients with advanced clear cell RCC or papillary RCC will be treated with~     everolimus in combination with CB-839. CB-Erl: patients with advanced NSCLC lacking the T790M~     EGFR mutation will be treated with erlotinib and CB-839. CBD: patients with NSCLC harboring~     KRAS mutation will be treated with docetaxel and CB-839. CB-Cabo: patients with~     histologically confirmed diagnosis of locally-advanced, inoperable or metastatic RCC treated~     with cabozantinib in combination with CB-839.~      All patients will be assessed for safety, pharmacokinetics (plasma concentration of drug),~     pharmacodynamics (inhibition of glutaminase), biomarkers (biochemical markers that may~     predict responsiveness in later studies), and tumor response.~   "
114263|NCT02071849|"~     The HAART 200 Aortic Annuloplasty during Bicuspid Aortic Valve Reconstruction Trial is a~     prospective, non-randomized, multi-center trial to evaluate the safety and effectiveness of~     the HAART 200 bicuspid annuloplasty ring when used to surgically stabilize the aortic valve~     annulus in patients undergoing repair of bicuspid aortic valves (BAV) for predominant aortic~     insufficiency (AI).~   "
114301|NCT02071355|"~     The purpose of this study is to determine the pharmacokinetics (what the body does to a~     medication) of TMC435 after multiple oral doses of 100 and 150 mg TMC435 once daily for 7~     days in healthy Chinese participants.~   "
115753|NCT02052336|"~     Primary Objective: To assess the effect of the coadministration of multiple dose of CJ-12420~     and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.~      Secondary Objective(s): To assess the safety of the coadministration of multiple dose of~     CJ-12420 and clarithromycin in healthy subjects~   "
114264|NCT02071836|"~     The overall objective of this project is to develop, evaluate, and disseminate a web~     application for first-time DWI offenders that will provide them with an age-appropriate brief~     motivational intervention (BMI) to motivate them to reduce their drinking and a cognitive~     behavioral intervention (CBI) for to help them achieve and maintain abstinence. The goal is~     to reduce heavy drinking and consequently the risk for future drunk driving.~      The specific objectives of this Phase II are:~        -  Completing the development of the Right Turns prototype based on feedback from the Phase~          I pilot study participants. This includes: providing more structure and guidance as~          participants work in the Tool Box section of the program; simplifying the content of the~          Tool Box; further R&D in the text messaging feature for 2nd and 3rd tier cellular~          providers; implement a customized pdf report function for progress reports from the~          program to users' probation officers (under control of the user); developing a follow-up~          component and outcome reports; and revising the videos in the Tool Box to reflect~          greater diversity and a younger population of drinkers.~        -  Conducting a randomized clinical trial of the program with first time DWI/DUI offenders~          who are recruited locally, collecting follow-up data, analyzing the data, and reporting~          the results.~   "
114265|NCT02071823|"~     The objectives of this study were to characterize the effects of food on the pharmacokinetics~     (PK) and tolerability of BIA 9-1067 in healthy male subjects.~   "
114266|NCT02071810|"~     The purpose of this study is to assess the tolerability of BIA 9-1067 after multiple rising~     dose regimens of BIA 9-1067.~   "
114267|NCT02071797|"~     The objective of the COOLCATH study is to compare the effect of the RhinoChill transnasal~     cooling system to current standard Blanketrol III cooling blanket in its ability to achieve~     therapeutic hypothermia (TH) induction for patients undergoing TH after cardiac arrest.~      The COOLCATH study will be a prospective, open-label randomized controlled trial comparing~     induction of TH efficacy and outcomes of patients following cardiac arrest. Any patient with~     return of spontaneous circulation (ROSC) following a cardiac arrest within the Essex~     Cardiothoracic Centre (CTC), or who is brought to the Essex CTC and is a candidate for TH~     will be considered for this study.~   "
114268|NCT02071784|"~     The aim of this study is to investigate using fMRI methods, EEG and dedicated mathematical~     models, the potential alterations of neurovascular coupling in CADASIL.~   "
114269|NCT02071771|"~     The purpose of this study is to evaluate functional vision associated with rotational~     stability at blink of DAILIES® AquaComfort Plus® Toric (DACP T) compared to 1-DAY ACUVUE®~     MOIST® for Astigmatism (1DAM A).~   "
114270|NCT02071758|"~     The purpose of this study is to compare the safety, tolerability, and immunogenicity in~     healthy adult subjects of an investigational vaccine being developed for the prevention of~     visceral leishmaniasis.~   "
114271|NCT02071745|"~     Total knee replacement is one of the most commonly performed orthopedic procedures. As of~     2010, about 600,000 total knee replacements were being performed annually in the United~     States and these numbers are rising. The normal knee joint functions as a complex hinge~     allowing primarily ﬂexion and extension, rotation and gliding. The knee joint is made up of~     three compartments, the lateral, medial and anterior (patellofemoral). Damage to the~     cartilage of one or more compartments may be the result of osteoarthritis (idiopathic or~     post-traumatic), inﬂammatory arthritis (rheumatoid,psoriatic, etc.), a-vascular necrosis,~     tumors, or congenital deformities. Osteoarthritis and rheumatoid arthritis are the causes of~     the overwhelming majority of total joint arthroplasties.~      A successful Total knee arthroplasty(TKA) surgery includes: an accurate alignment( the~     mechanical axis in axial and rotational planes), as well as significant pain relief which~     improves function and quality of life. Incorrect alignment can lead to abnormal wear,~     premature mechanical loosening of the components and patellofemoral problems.~      The common techniques for Total knee replacement are:~        1. Conventional method TKR~        2. CT/MRI-based preoperative navigated TKR~        3. Image-free intraoperative navigated TKR In our research we focus on the 3rd method using~          the Orthopilot navigation system Aesculap®, Tutlingen, Germany. This system is an active~          PC based guiding system that helps the surgeon decide on the accurate alignment and~          orientation of the implant and cutting surfaces of the bone and thus avoid incorrect~          alignment.~      We aim to compare between pre-operative and post-operative lower limb alignment (mechanical~     axis) in Aesculap based TKA using serview CT. Furthermore, we will try to examine the~     existence of a correlation between the CT scans and the Orthopilot navigation system output~     and assess the clinical outcome of the patient postoperatively.~      Our Hypothesis is that the intra-operative navigation system is accurate and correlated to CT~     images results, moreover, allows the surgeon to achieve a good mechanical axis and high~     clinical outcome,~   "
114272|NCT02071732|"~     The purpose of this study is to determine whether repetitive transcranial magnetic~     stimulation (rTMS) is effective in the treatment of tinnitus.~   "
114273|NCT02071719|"~     The rapid development of agents blocking kinases has established the use of molecularly~     targeted therapy as the preferred treatment approach for patients with metastatic renal cell~     cancer (RCC). Five kinase inhibitors (sunitinib, everolimus, temsirolimus, sorafenib and~     pazopanib) are now approved for clinical use. Response rates differ among these agents,~     importantly depending on line of treatment. In first-line treatment sunitinib results in 47%~     objective response rates, where in second-line after cytokines 34% responds. Thus far, it is~     unclear which patient with advanced renal cell cancer will respond to targeted therapy. In~     order to select patients for targeted therapies, several profiling approaches have been~     explored but to date no adequate and reliable test is available. It is assumed that responses~     to targeted agents depend on specific receptor and protein signalling activities in tumor~     tissues. Therefore, we propose that protein phosphorylation profiling with phosphoproteomics~     may be a potential clinical diagnostic tool to predict for tumor response to targeted~     therapy.~   "
114274|NCT02071706|"~     The investigational PET/MRI scanner, including attenuation correction method, is capable of~     producing diagnostic quality images and appropriate device functionality per user feedback.~   "
114275|NCT02071693|"~     To retrospectively investigate the relationship between the Cholinergic Pathways~     Hyperintensities Scale (CHIPS) score and the change of cognitive status of Parkinson's~     disease (PD) patients after bilateral subthalamic nucleus deep brain stimulation (STN DBS).~   "
114276|NCT02071680|"~     Patients with symptomatic atrial fibrillation (AF), a rapid beating of the upper heart~     chambers, can undergo catheter ablation to control or eliminate their rhythm disorder. The~     radiopharmceutical 123I-mIBG (Adreview™ GE Healthcare) has been introduced to visually~     identify cardiac innervation. This study will use non-invasive evaluation using MIBG imaging~     to study if we can predict baseline autonomic characteristics in patients with AF, as well as~     clinical outcome based on post ablation imaging~   "
114330|NCT02070978|"~     This is a multicenter, double-blind, Phase 2b, long-term extension (LTE) to the ADDRESS II~     core trial (EMR 700461-023) (NCT01972568), to evaluate long-term safety and tolerability of~     atacicept in subjects with systemic lupus erythematosus (SLE). The Week 24 visit of ADDRESS~     II core trial will coincide with the Day 1 visit of this LTE trial.~   "
114279|NCT02071641|"~     Targeted therapies are associated with (acquired) resistance after a median of 5-11 months of~     treatment, resulting in disease progression, while almost no tumors are intrinsically~     resistant in the first line setting. The investigators recently published that tumor cell~     resistance to sunitinib may be directly related to lysosomal sequestration of sunitinib. This~     resistance mechanism was shown to be transient, since a drug-free culture period could~     normalize the lysosomal storage capacity for sunitinib and resulted in recovery of drug~     sensitivity.~      In two reports it has been suggested that patients with metastatic Renal Cell Carcinoma who~     responded to sunitinib in the first-line setting may benefit from rechallenge with sunitinib~     after failure of second-line treatment. However, these data are retrospective. A prospective~     trial to investigate a rechallenge with sunitinib is needed to determine whether this~     strategy is of benefit for patients with mRCC with prior clinical benefit to sunitinib but~     who stopped treatment because of overt clinical resistance.~   "
114280|NCT02071628|"~     This study is designed for validation of in-vitro platelet aggregation assay using human~     blood in healthy volunteers. 32ml blood, 2ml for complete blood count test and 30ml for~     platelet aggregation assay, was collected from ten subjects, respectively.~      Preparation of Platelet Rich Plasma (PRP):~        1. Collect human blood using 21g butterfly syringe and dilute 9:1 into 3.8% sodium citrate~          vacutainer vials.~        2. Prepare platelet rich plasma (PRP) by centrifuging blood at 100 x g for 15 minutes at~          room temperature. Using a plastic transfer pipette, carefully transfer and combine PRP~          from multiple vacutainer tubes (if required) into a 15 mL conical tube.~        3. PRP is removed re-centrifuge remaining blood in vacutainer tubes at 2000 x g for 15~          minutes at room temp. to obtain platelet poor plasma (PPP). Transfer PPP to 15 mL~          conical tube.~        4. Measure platelet count in combined PRP using Z1 Coulter Particle Counter or similar~          product. Adjust platelet count to a final concentration of 300,000 +- 10,000 platelets~          in PRP using PPP.~      Aggregation Measurement:~      Aggregation is measured using a model 490-X Chrono-Log Aggregometer or similar product. PPP~     is used as a reference to establish 100% optical transmission.~   "
114281|NCT02071615|"~     In this study the investigators compare three stimulants to each other. The effects of these~     agents on cognitive performance (eg, attention and memory) and on the brain are being~     measured. The hypothesis is that stimulants will have a positive effect on cognitive~     performance.~      Each study participant will receive once a placebo and once methylphenidate or modafinil or~     caffeine. Methylphenidate (also known as Ritalin ®) is a drug that is used in the treatment~     of attention deficit / hyperactivity disorder (ADHD) in children, adolescents and adults.~     Modafinil ( Vigil ®) is a drug used in the treatment of narcolepsy (sleeping sickness). In~     the study. These substances are given in the study only once and in the dosages in which is~     also used for the treatment of the above diseases. In the case of caffeine , the dosage~     corresponds to two cups of coffee.~   "
114282|NCT02071602|"~     The primary endpoint is to assess the safety and tolerability of Cenderitide (CD-NP) with the~     incidence of symptomatic hypotension being one of the key safety variables.~   "
114283|NCT02071589|"~     Phase I, crossover, randomised, single dose, relative bioavailability clinical trial of a new~     oral solution of nifedipine compared to Adalat soft gelatine capsules in healthy female~     volunteers.~   "
114284|NCT02071576|"~     This clinical study has been planned to evaluate the safety and effectiveness of a common~     treatment algorithms (Proscan) using 500 Hz laser repetition rate.~   "
114285|NCT02071563|"~     This research will serve as a follow-up on the review of Title II commodities performed by~     the Food Aid Quality Review at Tufts University in October 2011. The study in Burkina Faso~     will test the relative effectiveness and cost effectiveness of four supplementary foods in~     the prevention of MAM and stunting in normal programmatic settings.~      The aims of this study are to:~        1. To compare the effectiveness of four alternative supplementary food commodities in~          preventing stunting and wasting, and promoting linear growth in children 6 - 23 months~          in the context of a preventive supplementary feeding program in Burkina Faso.~        2. To estimate the relative cost of implementing the supplementary feeding program using~          each commodity~        3. To estimate the relative cost/effectiveness of implementing the program using each~          commodity.~   "
114286|NCT02071550|"~     In this study the investigators investigated changes in hemodynamic parameters and cerebral~     oxygen saturation (rSO2) associated with 10 cmH2O PEEP, which is assumed beneficial for the~     respiratory functions and oxygenation during the laparoscopic cholecystectomy (LC) applied at~     the 30°head-up left side position, is compared with using two individual devices~     (INVOS-FORESIGHT).~      Methods: Afterwards the ethics committee approval of the hospital and receiving the written~     patients' consents, patients to undergo ASA I-II group elective laparoscopic surgery were~     randomly divided into two groups. Sensors of INVOS and FORESIGHT devices were placed on the~     right side forehead region. Totally 11 evaluation periods were formed, respectively:~     Pre-induction (1st Period), post-induction (2nd period), abdominal insufflation outset (3rd~     period): post-insufflation 5-minute intervals (4th, 5th, 6th, 7th 8th period), end of~     insufflation (9th period), end of operation (10th period) and end of anaesthesia (11th~     period). While one of the groups was not applied PEEP(ZEEP), the other group was applied 10~     cmH2O simultaneously with the abdominal insufflation proceeding. Demographic data,~     hemodynamic values and rSO2 values were recorded for both groups at all 11 periods.~   "
114287|NCT02071537|"~     The purpose of this research study is to test the safety of chloroquine in combination with~     carboplatin and gemcitabine and see what effects (good and bad) it has on advanced solid~     tumors.~      Also, the research study will be increasing the dose of chloroquine to find the highest dose~     of chloroquine that can be given in combination with carboplatin and gemcitabine without~     causing severe side effects.~   "
114288|NCT02071524|"~     The investigators hypothesize that large doses of fluids used during intraoperative could~     affect lung parenchyma structure and, consequently, gas exchange and respiratory mechanics.~     The purpose of this study is to evaluate fluids effects on oxygenation, respiratory~     mechanics, by using two different solutions: crystalloid or colloid.~   "
114289|NCT02071511|"~     Study hypothesis:~      With optimal medical therapy and repeated ablations, an additional renal denervation may have~     protective effects in terms of vegetative intrinsic activity and lead to a significant~     reduction in VT Burdens.~      Study design:~      Multicenter, randomized, prospective, single-blind clinical trial.~   "
114290|NCT02071498|"~     Background: Non-adherence and medication errors are common among patients with complex drug~     regimens. Applications for smartphones and tablets are known to be effective for improving~     adherence but they have not been tested in elderly patients with such complex chronic~     conditions, their older age meaning they tend to have less experience with this type of~     technology.~      Objective: to design, implement and evaluate a medication self-management application for~     elderly patients taking multiple medications called ALICE with the intention of improving~     adherence and safe medication use.~      Methods: A single-blind randomized controlled trial was conducted with a control and an~     experimental group (N=99) in Spain in 2013. The characteristics of ALICE were specified based~     on the suggestions of 3 nominal groups with a total of 23 patients and a focus group with 7~     professionals. ALICE was designed for Android and iOS and to allow the personalisation of~     prescriptions and medical advice, showing images of each of the medications (the packaging~     and the medication itself) together with alerts and multiple reminders for each alert. The~     randomly subjects in the control group received oral and written information on the safe use~     of their medications and the experimental group used ALICE for three months. Pre- and post-~     measures included: rate of missed doses and medication errors reported by patients, Morisky~     Medication Adherence 4 items Scale scores, level of independence, self-perceived health~     status and biochemical test results of the patients. In the experimental group, data were~     also collected on their previous experience with information and communication technologies,~     their rating of ALICE and their perception of the level of independence they had achieved.~     The inter-group intervention effects were calculated by univariate linear models and ANOVA,~     with the pre- to post-intervention differences as the dependent variables.~   "
114291|NCT02071485|"~     A brain-computer interface (BCI) is a system that provides a separate output pathway for~     neurological signals whereby they can be interpreted to determine the user's intended~     cognitive action. Utilizing EEG-based sensorimotor rhythms (SMRs) generated in the motor~     cortex has allowed subjects to control virtual computer cursors in up to three dimensions by~     simply imagining the movement of a specified body part. Nevertheless, the scalp EEG signals~     are smeared by the volume conduction effect and measurement noise. The overall hypothesis of~     this study is that EEG-based virtual object control may help reveal optimal motor imagination~     tasks best used in a BCI.~      The PI's hypotheses include: (1) The use of advanced signal processing techniques will better~     reveal characteristics of EEG signals that represent the underlying motor cognitive function~     of the subject; (2) BCI systems based on SMR generated using motor imaginations will allow~     effective control of a virtual object in real time; (3) EEG imaging techniques will provide~     insight into the areas of cortical activation during a motor imagery task that can be~     utilized to increase the spatial resolution of non-invasive BCI's.~   "
114292|NCT02071472|"~     The objective is to evaluate the impact of an electronic pharmaceutical record used for~     medication reconciliation by a pharmacist associated to the anesthesiologist consultation~      Experimental intervention:~      medication reconciliation by a pharmacist using an electronic pharmaceutical record before~     the anesthesiologist consultation for planned surgery patients. The clinical pharmacist~     communicates the recommendations regarding the drug therapy to the anesthesiologist orally~     and using a specific formulary.~      Control intervention:~      Conventional anesthesiologist consultation for planned surgery patients.~   "
114293|NCT02071459|"~     Evaluate the effects of L-Threo DOPS on orthostatic hypotension symptoms and other non-motor~     symptoms in patients with Multiple System Atrophy (MSA) after 12 weeks following~     randomization to continued therapy with droxidopa or placebo.~   "
114294|NCT02071446|"~     Deep Brain Stimulation (DBS) is an FDA approved, and widely used method for treating the~     motor symptoms of Parkinson's Disease (PD), Essential Tremor (ET) and Dystonia. Over 100,000~     patients worldwide have now been implanted with DBS devices. The DBS target regions in the~     brain are the Subthalamic nucleus (STN), the Internal Segment of Globus Pallidus (GPi), or~     the Ventral Intermediate Nucleus of the Thalamus (VIM). In order to place the DBS electrode~     in the target location, a combination of two 3D imaging techniques; 3D MRI and CT, are used.~     Data are also collected from individual nerve cells to help find the best location for the~     DBS electrode in each patient. This electrode recording takes place during the standard~     surgical implantation of the DBS electrode, and is part of the standard clinical technique.~     The investigators plan to collect additional data from populations of neurons during the DBS~     surgery in an effort to further improve the placement of the DBS electrode. These Local~     Field Potentials, LFPs, represent the activity of the collection of neurons surrounding the~     tip of the electrode, and will be measured during surgery along the path used for the~     placement of the DBS electrode. The goal of this project is to determine whether this~     additional data from surrounding neurons will help with optimal placement of the DBS~     electrode.~   "
114295|NCT02071433|"~     The purpose of this study is to determine whether blockade of the saphenous nerve can provide~     the same degree of analgesia postoperatively for ACLS as a femoral nerve block without~     resulting motor blockade enhancing shortening of hospital stay en functional outcome.~   "
114296|NCT02071420|"~     Our objective in this pilot study is to test the combined effect of a) replacing office~     workers' sedentary workstations with active workstations (LifeBalance Station) and b)~     optimizing computer workstation ergonomics on daily occupational sedentary time,~     cardiometabolic risk factors, musculoskeletal symptom health outcomes and work productivity.~   "
114297|NCT02071407|"~     To explore the cerebral protective effect of midazolam in patients with traumatic brain~     injury, we will collect blood samples from patients treated with or without midazolam when~     the patient is admitted to ICU, 24 h, 48 h and 72 h after the admission before the use of~     midazolam for patients in group N1, and before the patient is treated with midazolam, 24 h，~     48 h, 72 h after the use of midazolam for patients in group N2. Parameters of cerebral~     metabolism and inflammatory response will be obtained from the blood samples or the~     cerebrospinal fluid. With the aforementioned parameters, the relationship between clinical~     outcome and cerebral metabolism and inflammatory response will be detected with statistical~     method.~   "
114298|NCT02071394|"~     This study examines the effect of inhaled xenon gas in the treatment of newborn infants with~     hypoxic-ischemic encephalopathy (HIE) in combination with cooling, which is the standard~     treatment for this condition. The hypothesis is that the xenon + cooling combination will~     produce better neuroprotection than the standard treatment of cooling alone.~   "
114299|NCT02071381|"~     The purpose of this study is to evaluate drugs interactions to compare pharmacokinetics in~     groups of monotherapy DW330SR, monotherapy DW1030, and coadministration DW330SR and DW1030~   "
114300|NCT02071368|"~     The purpose of this study is to assess the bioequivalence (similarity of the drug amount in~     blood among the formulations) of the fixed dose combination (two components combined in one~     tablet) of canagliflozin and metformin extended release (XR) tablet (dose of 2 X 150~     mg/500mg) with respect to the individual components of canagliflozin (1 x 300 mg) and~     metformin XR tablet (2 x 500 mg) in healthy fed participants.~   "
114304|NCT02071316|"~     The purpose of this study is to conduct a randomized control trial, double-blind study to~     compare Hexacapron with standard of care treatment to standard of care alone to evaluate the~     efficacy of adding effect of Hexacapron to standard therapy by decreasing the episodes of~     rebleeding and mortality in patient with upper gastrointestinal bleeding.~   "
114305|NCT02071303|"~     The purpose of this study is to compare the effectiveness of Tramadol and Celecoxib in~     reducing pain during outpatient hysteroscopy. Women undergoing outpatient hysteroscopy in~     Cairo university will be divided into 3 groups, the first group will receive Tramadol 100 1~     hour before the procedure, the second group will receive Celecoxib 200mg 1 hour before the~     procedure and the third will receive a placebo. Pain will be assessed by a visual analogue~     scale.~   "
114306|NCT02071290|"~     The purpose of the study is to evaluate whether remote ischemic conditioning is a safe and~     effective intervention to prevent the development of inflammation and coagulopathy in trauma~     patients with hemorrhagic shock.~   "
114307|NCT02071277|"~     Mechanical ventilation (MV) is a cornerstone of management of acute respiratory failure, but~     MV per se can provoke ventilator-induced lung injury (VILI), especially in acute respiratory~     distress syndrome (ARDS). Lung protective ventilation strategy has been proved to prevent~     VILI by using low tidal volume of 6-8 ml/kg of ideal body weight and limiting plateau~     pressure to less than 30 cmH2O. However, heavy sedation or even paralysis are frequently used~     to ensure the protective ventilation strategy, both of which are associated with respiratory~     muscles weakness. Maintaining of spontaneous breathing may decrease the need of sedative drug~     and improve gas exchange by promoting lung recruitment.~      Pressure-targeted mode is the most frequent way of delivering after 48 hours of initiating~     MV. Three types of pressure-controlled mode are available in intubated patients: Biphasic~     Intermittent Positive Airway Pressure (BIPAP), Airway Pressure Release Ventilation (APRV),~     and Pressure-Assist Controlled Ventilation (also called BIPAPassist). They are based on~     pressure regulation but have the difference in terms of synchronization between the patient~     and the ventilator. The different working principle of these modes may result in different~     breathing pattern and consequently different in tidal volume and transpulmonary pressure,~     which may be potentially harmful. The investigators bench study with a lung model~     demonstrated higher tidal volume and transpulmonary pressure with the BIPAPassist over APRV~     despite similar pressure settings and patient's simulated effort. However, the impact of each~     mode on the delivered tidal volume and the transpulmonary pressure in spontaneously breathing~     mechanically ventilated patients is currently unknown. Their hypothesis is that when the~     investigators compare the three pressure-controlled modes, the asynchronous mode (APRV) will~     result in more protective ventilation strategy over the two other modes (BIPAP and~     BIPAPassist).~   "
114308|NCT02071264|"~     This study will implement a socio-behavioral intervention in Quezon City, the Philippines,~     using a community-based participatory approach. The intervention involves 1-2 psychosocial~     and health education training workshops for the establishment managers and their workers,~     focusing on HIV/AIDS risk reduction information and condom use and condom negotiation~     skill-building. Participants will also be invited to do dream-building activities that~     explore their personal goals and goals for their organization of peers.~   "
114309|NCT02071251|"~     Approximately 500,000 surgical site infections occur annually in the US. These lead to worse~     patient quality of life, more outpatient and emergency room visits, readmissions and home~     services, with an estimated increase in costs of at least $3500 per complication. Surgical~     site infections are associated with increasing body mass index. There is limited and~     conflicting data of the utility of multiple surgical interventions to decrease the risk of~     surgical site complications. The investigators explored the effect of a prospective care~     pathway for closure of vertical abdominal wounds on patient's wound complications.~   "
114310|NCT02071238|"~     Understanding of an operation and its risks has been shown to give patients more realistic~     expectations, increase cooperation and result in higher satisfaction. Traditionally, informed~     consent for surgical procedures involve a discussion between the surgeon and the patient, but~     many patients easily forget the details of these talks. The investigators wish to investigate~     if providing a written pamphlet along with the standard oral discussion improves patients'~     ability to remember the details of the operation, improving the quality of the informed~     consent process.~      In addition, we will test whether a group consultation format provides a model for~     large-volume, low-variation, low-urgency surgery without reducing ability to recall risks of~     surgery or overall satisfaction.~   "
114311|NCT02071225|"~     This phase II trial was designed to evaluate the efficacy of obinutuzumab and bendamustine~     treatment in participants with refractory or relapsed chronic lymphocytic leukemia (CLL).~     Participants receive up to six 28-day cycles of treatment. Treatment consists of intravenous~     (IV) administration of obinutuzumab and bendamustine. Treatment time is expected to last 6~     months, and participant follow-up will last 2 years.~   "
114312|NCT02071212|"~     The purpose of this study is to investigate the potential acute and chronic effect of~     ticagrelor versus clopidogrel on arterial stiffness and other vascular risk markers of~     interest, the study will consist of two periods: a 24-hour ACUTE period where 60 subjects~     with an indication for coronary angiography (CA) with or without percutaneous coronary~     intervention (PCI) will be included, and a 30-day CHRONIC period where approximately 60~     subjects that will undergo PCI will be included and studied (refer to Section 3 'Study Plan~     and Procedures'). The primary objective of this study is to compare ticagrelor versus~     clopidogrel regarding their effect on arterial stiffness as assessed by PWV, at 3 hours after~     the loading dose of each regimen, in eligible subjects with CAD.~   "
114313|NCT02071199|"~     The purpose of this study is to evaluate the safety of oral topical application of~     Amnion-derived Cellular Cytokine Solution (ACCS) in subjects with gingivitis~   "
114314|NCT02071186|"~     The purpose of this study is to test the hypothesis that cognitive remediation and virtual~     reality treatment approaches can enhance cognitive and motor function in children with ADHD.~   "
114315|NCT02071173|"~     The objective of the NAVIGATE X4 Clinical Study is to gather data to establish the safety,~     performance and effectiveness of the ACUITY™ X4 quadripolar coronary venous leads and the~     RELIANCE 4-FRONT™ ventricular defibrillation leads to satisfy FDA requirements for pre-market~     submission. Additionally, data from this study will be used to support post-market approval~     requirements for the ACUITY X4 and RELIANCE 4-FRONT leads.~   "
114316|NCT02071160|"~     The aim of this study is to examine the effect of combining melatonin to whole body cooling~     on the brain injury and outcome of neonates following perinatal asphyxia.~   "
114331|NCT02070965|"~     The purpose of this study is to evaluate the potential of DFD01 spray to suppress the HPA~     (hypothalamic-pituitary-adrenal) axis as compared to Comp01 lotion when applied twice daily~     for 15 days.~   "
115754|NCT02052323|"~     The purposes of this study is to determine parasitological clearance rates by microscopy for~     the 72-hour period after first artesunate dose in subjects with uncomplicated P. falciparum~     malaria.~   "
114317|NCT02071147|"~     Purpose:~      To examine the safety of omitting the routine postoperative eye clinic review following~     phacoemulsification cataract surgery.~      Background:~      Approximately 300000 cataract extractions are performed annually in the NHS in England,~     requiring a similar number of post-operative visits, the majority of which result in no~     change in management. A conservative estimate of 70% of visits being unnecessary suggests a~     potential saving to the NHS of approximately £10M annually.~      What's involved:~      The study involves some questionnaires during the duration of the study. These include~     questionnaires relating to the quality of life of the patient (conducted before the~     operation, and at the 3 month research clinic) and a patient satisfaction questionnaire.~     There is also a research clinic 3 months following the operation.~      What are the risks/benefits:~      There are no real personal benefits to patients on the trial. The trial aims to provide very~     important information regarding the safety of discharging patients immediately after surgery.~     However the trial could potentially save many thousands of unnecessary hospital visits each~     year.~   "
114318|NCT02071134|"~     The purpose of this registry is to compile characteristics of world-wide outcomes for the use~     of Boston Scientific's commercially available Vercise DBS system in the treatment of~     Parkinson's disease.~   "
114319|NCT02071121|"~     The primary objective of this study is to evaluate the safety and tolerability of single~     doses of BIIB061 administered to healthy adult volunteers. Secondary objectives in this study~     population are to determine the single-dose pharmacokinetic (PK) profile and the absolute~     bioavailability (Fabs) of BIIB061 and to determine the effects of food intake (high-fat,~     high-calorie meal) on BIIB061 PK and safety.~   "
114320|NCT02071108|"~     To study the safety and performance of the Shockwave Medical Lithoplasty System in subjects~     to demonstrate that the Shockwave device can safely and effectively deliver localized~     shockwave energy for balloon dilatation of calcified, stenotic, infrainguinal peripheral~     arteries.~   "
114321|NCT02071095|"~     This study involves researching new approaches to treating HIV infection. Currently, HIV~     infection is treated with combinations of drugs called antiretrovirals. These drugs protect~     cells from infection by interfering with the viruses' ability to make copies of itself by~     infecting new target cells. Though these drugs are very effective, they cannot cure HIV~     infection and must be taken each and every day at prescribed doses to maintain their~     beneficial effect. This research study is investigating a new approach that involves an~     addition to existing medications.~      The study is investigating a medication called Poly-ICLC (Hiltonol®, Oncovir), which is an~     adjuvant. Adjuvants are medications that are designed to boost your body's immune responses~     resulting from a vaccine. The investigators want to test whether Poly-ICLC is an adjuvant~     that is effective in HIV-infected patients. A vaccine is not given in this study, but just~     investigating the adjuvant, Poly-ICLC, to determine whether it may be safe and useful in~     future vaccines that could be used to treat HIV, called therapeutic vaccines. One goal of~     future therapeutic vaccines is to reduce the virus that remains persistently inside of cells~     in a dormant or resting state despite treatment with HIV medications. This persistent pool is~     termed the latent virus pool or viral reservoir. One tactic to reduce this viral~     reservoir is to first stimulate HIV to start replicating in order to force it out of hiding.~     Once viral replication occurs, the infected cells may then be recognized and killed by cells~     of the immune system. Therefore, we also want to see what effect Poly-ICLC has on the virus~     that lives inside of cells. Specifically, the investigators want to look at whether Poly-ICLC~     increases the level of virus inside your cells while also improving your immune system's~     responses.~      The investigators are doing this research in hope to find new ways to treat HIV infection~     that may reduce exposure to medications that are called antiretrovirals. Antiretrovirals are~     medications used to treat HIV infection. They are very effective but have side effects and~     have to be taken each and every day and cannot cure HIV.~   "
114322|NCT02071082|"~     This study will assess the efficacy, safety, and tolerability of~     elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose~     combination (FDC) in human immunodeficiency virus (HIV)/hepatitis B virus (HBV) coinfected~     adults.~      Participants will be enrolled into two cohorts:~        -  Cohort 1: HIV/HBV coinfected adults who are HIV treatment-naive and HBV treatment-naive~        -  Cohort 2: HIV/HBV coinfected adults who are HIV-suppressed~   "
114323|NCT02071069|"~     1. To evaluate efficacy, safety, and feasibility of maintenance therapy with Cetuximab~          combined with irinotecan or fluorouracil after Cetuximab plus irinotecan and~          fluorouracil(FOLFIRI) in patients with incurable colorectal cancer.~        2. The relevant phase III studies reported that the progression free-survival of cetuximab~          combined with FOLFIRI in advanced colorectal cancer was 4.3 months up to 6.8 months.~      This study assumed that the progression free-survival was 5.1 months which was not inferior~     to the continuous chemotherapy~   "
114324|NCT02071056|"~     The purpose of this study is to learn whether the DNA from cancer tumor cells can be found in~     the cerebral spinal fluid (CSF) that bathes the brain and spinal cord of patients before~     malignant the cancer cells themselves are able to be found in the CSF. The researchers doing~     this study hope this information can be used to develop a way to diagnose LM earlier .~   "
114325|NCT02071043|"~     Gastric cancer with para-aortic lymph node (PAN) involvement is regarded as advanced disease,~     and only chemotherapy is recommended from the guidelines. In unresectable cases, neoadjuvant~     chemotherapy could prolong survival if conversion to resectability could be achieved.~   "
114326|NCT02071030|"~     The purpose of this study is to evaluate the efficacy and cost-effectiveness of Cone Beam~     Computed Tomography (CBCT) compared to panoramic radiography prior to removal of third molars~     in reducing patient's morbidity. Adults having a close relationship between the mandibular~     canal and one or both lower third molars, as diagnosed from digital panoramic radiographs~     will be recruited for this randomised controlled trial. In one trial arm, patients will~     receive the standard digital panoramic radiograph prior to third molar surgery. In the second~     arm, subjects will undergo an additional Cone Beam Computed Tomography (CBCT) prior to third~     molar surgery.~      All patients require a postoperative visit one week after surgery to assess the outcome.~   "
114327|NCT02071017|"~     Background and purpose: In adult, the half of the CNS neoplasms are metastatic, and high~     grade astrocytomas and oligodendrogliomas are most frequent malignant tumors among the last~     half. Recently, integrated MRI-PET (Biograph mMR, Siemens, Germany) was introduced, and can~     provide simultaneous whole body MRI-PET imaging as well as brain-specific advanced imaging~     (e.g. DWI, PWI, and DCE). The purpose of the present study is to evaluate whether the~     simultaneous MRI-PET acquisition can improve the diagnostic yield for the patients initially~     presented with brain tumors, and predict the prognosis in the patients diagnosed with primary~     high graded astrocytoma or oligodendroglioma.~   "
114328|NCT02071004|"~     This is a phase 1, open label, single dose study, after 5 days of aspirin treatment, in~     healthy male and female subjects. It is hypothesized that co-administering DS-1040b with~     aspirin at steady state will be safe and well tolerated by healthy male and female subjects.~   "
114329|NCT02070991|"~     Study to evaluate if macitentan is safe and tolerable enough to be used for treatment of~     subjects with combined pre- and post-capillary pulmonary hypertension (CpcPH) due to left~     ventricular dysfunction.~   "
114332|NCT02070952|"~     The purpose of this study is to determine the side effects and how effective CyberKnife~     stereotactic ablative body radiation (SABR) is in patients with prostate cancer. The~     CyberKnife system is a new type of radiation machine that uses a special system to precisely~     focus large doses of x-rays on the tumor. The device is designed to concentrate large doses~     of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be~     minimal. The purpose of this evaluation is to see if this treatment will help patients with~     low to intermediate risk prostate cancer and to evaluate the effect of this treatment on the~     patients' quality of life over time.~   "
114333|NCT02070939|"~     This single and multiple ascending dose study is the first evaluation of PF-0626414, a~     Selective Androgen Receptor Modulator in humans. The goal is to assess the safety,~     tolerability, pharmacokinetics and pharmacodynamics in healthy western and Japanese male~     subjects .~   "
114334|NCT02070926|"~     The CRONOS-ADM (Coronary CT angiography evaluation for clinical outcomes in asymptomatic~     patients with type 2 diabetes mellitus) registry is a large, prospective observational~     registry of demographic, clinical and laboratory data with long-term clinical outcome of~     asymptomatic diabetic patients without history of CAD or angina or angina-equivalent symptoms~     at two affiliated hospitals of The Catholic University of Korea.~   "
114335|NCT02070913|"~     A single-center, prospective case series clinical study consecutively enrolling up to 10~     patients with expected duration of 12 months or less. The study objectives are to evaluate~     retention and the feasibility of integrating therapeutic hypothermia using the ZOLL IVTM~     System.~   "
114336|NCT02070900|"~     The study will be conducted at 32 health care facilities in three provinces in Zimbabwe and~     will compare the impact of the provision Point of Care CD4 technology and early knowledge of~     CD4 levels on retention at 12 months, with or without POC CD4 and a programmatic mentoring~     package. Option B+ will be implemented at all sites and 16 intervention sites will receive~     POC CD4 machines and visits from a team of clinical mentors.~      The study also aims to assess rates of ART initiation and time to ART initiation of HIV~     positive pregnant women in settings implementing option B+ with or without POC CD4 and~     related counselling/support; rates of retention in care of HIV positive mothers at 6 months~     post ART initiation in settings implementing option B+ with or without POC CD4 and related~     counselling/support; rates of ART initiation and retention at 6 and 12 months post ART~     initiation according to different levels of CD4 count; cost of retaining HIV positive~     pregnant women until 6 and 12 months; acceptability and feasibility of POC CD4 as an adjunct~     to good clinical care of HIV positive pregnant women.~   "
114337|NCT02070887|"~     The overall aim of this observational study is to investigate the impact of COMT inhibition~     on homocysteine metabolism, vascular physiology and correlates of neurodegeneration in PD~     patients with certain COMT genotype. It is designed to evaluate effect size of Hcy lowering~     to secondary outcome parameters. Assessment of outcome parameters will be rater-blinded or~     computer-based.~   "
114338|NCT02070874|"~     Patients in isolated rural settings often lack easy access to pain care and specialist~     services. Yet rural residents are more likely than their urban counterparts to be older; be~     in poorer overall health; suffer from more chronic or serious illnesses and disabilities; be~     uninsured or underinsured; and live in poverty. Telehealth is an emerging method of health~     care delivery that has been found useful and effective in many clinical settings and~     specialties. Telehealth technologies can bridge geographic distance and increase access to~     specialist care in rural settings. The investigators propose a cluster randomized clinical~     trial design to test the effects of a telehealth-enhanced palliative care pain-management~     program for 240 patients and 40 providers in rural health care settings. The proposed program~     will provide services to both patients and providers: Patients will conduct self-assessments~     and report pain and other symptoms via telehealth. Health care providers will receive~     telehealth-delivered case consultations that will include case management, evidence-based~     practice resources, and peer support. Providers and their patients will be randomly assigned~     to intervention groups, which receive the telehealth-enhanced palliative care pain-management~     intervention, or to control groups. The investigators primary aim is to compare patient~     self-reports of pain and quality of life in the intervention and control groups over 2~     months. Aim 2 is to examine, in the intervention and control groups over 2 months, providers'~     knowledge and attitudes regarding pain and perceived competence in treating pain. Aim 3 is to~     evaluate the cost-effectiveness of the telehealth intervention. The investigators will use~     mixed effects models with patients nested within providers to evaluate the effect of the~     intervention on study outcomes. Findings from this study will be instrumental in advancing~     telehealth and improving pain management and palliative care among underserved rural~     populations.~   "
114339|NCT02070861|"~     The investigators hypothesize that changes in blood circulation can be reflected by exhaled~     CO2 provided CO2-production in the tissues and ventilation from the lungs are stable. The~     investigators want to explore changes in cardiac output (the amount of blood being pumped out~     of the heart each minute) in patients using different devices: an esophagus ultrasound device~     measuring cardiac output, a finger cuff measuring blood pressure and cardiac output, and~     exhaled carbondioxide in the patients` breath measured by the ventilator.~      The investigators investigate patients after bypass surgery or heart valve replacement, and~     induce changes in cardiac output with passive leg raise or ventricular pacing.~   "
114340|NCT02070848|"~     Physical exercise triggers various physiological responses including a marked increase in~     muscle blood flow and oxygen delivery in order to support muscle activity. How muscle blood~     flow is controlled is currently unclear.~      The primary purpose of this study is to establish the respective contribution of metabolic~     (linked to energy requirements) and mechanical (linked to muscle tensions) signals in the~     exercise hyperemia and the possible role of the red blood cells.~      Vasodilation and muscle blood flow during exercise are controlled by ATP released in the~     plasma from the red blood cells in response to a combination of metabolic and mechanical~     signals applied on the vasculature.~   "
114341|NCT02070835|"~     Diabetic foot ulcer is one of the refractory wounds and always poses many challenges in~     clinical practice. This study was conducted to have a prospective, randomised, controlled~     study compare the safety and efficacy of the ReCell® technology with skin graft (experiment~     group) with split-thickness skin graft (STSG, control group) alone on treating diabetic foot~     ulcers.~   "
114342|NCT02070822|"~     This study is a prospective clinical study using DCE-MRI, DWI and MRS in 3T scanner to~     evaluate tumors in patients with unresectable HCC after TACE. A total of 100 subjects will be~     recruited. MRI will be performed before TACE (day 0), day 14, and day 28 to assess the tumor~     responses. After day 28, all subjects will receive standard clinical care and be follow-up~     for 1 year. The imaging parameters will be compared among each MRI and correlate with~     patients' outcome. The investigators hypothesis that it might be helpful to combine DCE-MRI,~     DWI, and MRS for assessment of tumor response after TACE and predict patients' prognosis.~   "
115755|NCT02052310|"~     The purpose of this study is to determine whether FG-4592 (roxadustat) is safe and effective~     in the treatment of anemia in patients who have just begun dialysis treatment for end stage~     renal disease.~   "
114343|NCT02070809|"~     A wound comprises a break in epithelial continuity and disruption of structure and function~     of underlying tissues, the treating and repairing is always a great challenge in clinical~     practice. The complex healing process make the wound easy to get a tendency of nonhealing and~     result in a heavy burden of life quality. Nowadays surgical repairing is still the main~     method, but there was still no effective and satisfy outcomes. Because none of the treatments~     could repair skin both on structure and function. Now the investigators provide a quick and~     effective method to rebuilt complete structure and function of the skin based on~     tissue-engineered skin technology. To further test the efficacy and safety of this new~     method, the investigators propose a prospective randomized controlled multicenter trial to~     compare this method with traditional skin graft.~   "
114344|NCT02070796|"~     The primary objective of the study is to establish Bioequivalence (BE) of 2 different~     formulations of the 2 mg/24 hr (10 cm^2) Rotigotine transdermal patches in Chinese subjects.~   "
114345|NCT02070783|"~     Studies on the hormone Erythropoietin (EPO) have indicated that EPO may have antidepressant~     properties. However, EPO may cause serious side-effects with repeated administration~     (thrombosis), which limits its usefulness as an antidepressant. ARA290 is a peptide that does~     not have the effects of EPO on blood cells but may still have its effect on brain function.~     In an attempt to replicate previous findings with (a single dose of) EPO in healthy~     volunteers, we study the effects of ARA290 on the cognitive and neural processing of emotions~     in healthy volunteers. We hypothesize that a single dose of ARA290 will lead to a positive~     shift in information processing compared to placebo, 7 days post-administration.~   "
114346|NCT02070770|"~     The purpose of this study is to determine whether short-term adherence to a very low calorie~     diet is effective in improving heart rate variability in obese individuals.~   "
114347|NCT02070757|"~     This is a phase 3, multicenter, prospective, randomized study of intravenous (IV)~     ceftolozane/tazobactam vs. IV meropenem in the treatment of adult participants with either~     ventilator-associated bacterial pneumonia (VABP) or ventilated hospital-acquired bacterial~     pneumonia (HABP).~   "
114348|NCT02070744|"~     The objective of this study was to evaluate the safety and efficacy of VX-661in combination~     with ivacaftor in participants with cystic fibrosis (CF) who are homozygous for F508del~     cystic fibrosis transmembrane conductance regulator (CFTR) mutation~   "
114349|NCT02070731|"~     A randomized evaluation of the TriGuard™ HDH embolic deflection device during transcatheter~     aortic valve implantation.~   "
114350|NCT02070718|"~     Studies suggest that kappa agonists (KA) and peripherally restricted kappa agonists (PRKAs)~     may affect thermoregulation. This pilot study has the aim to establish proof of concept~     regarding efficacy of an oral kappa agonist (KA) for the treatment of menopausal hot flashes.~   "
114351|NCT02070705|"~     This clinical trial studies an imaging technique known as dynamic contrast enhanced magnetic~     resonance imaging (DCE MRI) in identifying the presence of pancreatic cancer. DCE MRI is a~     procedure that takes detailed pictures of functional and structural properties inside the~     body using magnetic field and radio frequency pulses. These pictures may help identify~     underlying malignancy in patients at high risk or active malignancy in patients who have~     undergone chemotherapy for pancreatic cancer.~   "
114352|NCT02070692|"~     The purpose of this study is to study whether a drug called tamoxifen can reduce vaginal~     bleeding in women who are using the Etonogestrel contraceptive implant.~   "
114353|NCT02070679|"~     The purpose of this study is to evaluate the effect of vitamin E on preventing from incidence~     of contrast induced acute kidney injury (CI-AKI) in the patients who undergone coronary~     angiography.~   "
114354|NCT02070666|"~     The investigators hypothesis is that patients at risk of ARDS, detected by LIPS (Lung Injury~     Prediction Score), under mechanical ventilation could benefit from a protective ventilatory~     strategy (used in ARDS treatment) in order to avoid or decrease the ARDS development. This~     would lead to a decrease in incidence, mortality and health care costs associated to this~     syndrome.~      This study will help to confirm the current evidence about low tidal volumes, evaluating~     adverse events of this strategy.~   "
114355|NCT02070653|"~     Abdominal aortic aneurysm (AAA) is a major health problem and ruptured AAA is a common cause~     of death in Europe and North America. A key limitation of contemporary treatment strategies~     of AAA is the lack of therapy directed at reducing expansion. Although surgical repair is an~     effective treatment for large AAA, it is associated with significant mortality and morbidity~     as well as substantial cost. The rationale for this randomized controlled study is to~     investigate whether treatment with Ticagrelor inhibits growth of small abdominal aortic~     aneurysms.~   "
114356|NCT02070640|"~     The purpose of this study is to evaluate an imaging system using Indocyanine Green (ICG) to~     assist in real-time identification of anatomy during cholecystectomy (gallbladder removal).~     We propose to define the effectiveness of NIRF-C in identifying the cystic duct junction~     during cholecystectomy.~   "
114357|NCT02070627|"~     The purpose of this study is to evaluate an imaging system using Indocyanine Green (ICG) to~     assist in real-time identification of anatomy during cholecystectomy (gallbladder removal) in~     patients with acute cholecystitis and cholangitis. We propose to define the effectiveness of~     NIRF-C in identifying the cystic duct junction during cholecystectomy.~   "
114358|NCT02070614|"~     This study was designed for exploring the association of cytochrome P450 3A4 rs2242480~     polymorphism with metabolism of sufentanil in Chinese patients receiving upper abdominal~     surgery，to provide evidence for genetic prediction of personalized medication.Methods:60~     patients who prepared for elective upper abdominal surgery under general anesthesia were~     recruited into study. Liver enzyme inhibitor should be excluded in anesthesia. rs2242480~     genotyping was carried out by direct sequencing. The blood samples were drawn before~     anesthesia，30 min and 45min after anesthesia respectively，used for plasma sufentanil~     concentration detection with high performance liquid chromatography-mass spectrometry~     (HPLC-MS). After surgery，the patients received patient-controlled intravenous sufentanil~     immediately. And postoperative pain at rest，sufentanil consumption，side effects and rescue~     analgesic requirements were recorded at the 6th，12th，24th hour. The plasma sufentanil~     concentration and PCA sufentanil consumption were analyzed to investigate the differences~     among rs2242480 three genotypes.~   "
115797|NCT02051764|"~     This study will evaluate the imaging characteristics of 18F-AV-1451 in subjects with a~     previous 18F-AV-1451 scan in order to assess the rate of change of tau deposition over time.~   "
114359|NCT02070588|"~     This feasibility study is being conducted to determine potential associations between a broad~     range of clinical neurological symptoms and magnetic resonance images (MRI), data, and~     clinical findings involved in mild traumatic brain injury (mTBI).~      These associations will be examined over the acute and sub-acute period (approximately 3~     months) following injury to provide information useful for optimization of MR pulse sequences~     for mTBI applications.~      Correlations exist over the sub-acute period in clinical neurological and MR data (images,~     image reads, and RAW data), which may indicate temporal evolution patterns. The intent of~     this study is to broadly generate potential biomarkers of temporal evolution of mTBI~     detectable in MR images and data (MR mTBI biomarkers).~   "
114360|NCT02070575|"~     The purpose of this study is to investigate if a new blood test looking at PSA and a group of~     PSA related proteins in a patient's blood can indicate which men after surgery with a rising~     PSA could benefit from treatment, and/or indicate which men are at higher risk for recurrence~     before initial treatment is given.~   "
114361|NCT02070562|"~     This study aims to investigate breast milk composition and dietary habits of Chinese~     lactating mothers. Further understanding of the composition of human milk will help to~     understand the nutritional needs of mothers and their infants in their early phase of life~     which eventually will help to support breastfeeding.~   "
114362|NCT02070549|"~     This phase I trial studies the side effects and best dose of trametinib in treating patients~     with cancer that has spread to other places in the body and usually cannot be cured or~     controlled with treatment (advanced) with or without liver (hepatic) dysfunction. Trametinib~     may stop the growth of tumor cells by blocking proteins needed for cell growth. When these~     proteins are blocked, the growth of cancer cells may be stopped and the cancer cells will~     then die. Hepatic dysfunction is frequently found in patients with advanced cancer and~     usually prevents patients from receiving standard treatments or from participating in~     clinical trials. Patients may also need dose adjustments or absorb drugs differently.~     Trametinib may be a better treatment for patients with advanced cancers and hepatic~     dysfunction.~   "
114363|NCT02070536|"~     Current clinical prediction scores for acute respiratory distress syndrome (ARDS) have~     limited positive predictive value. No studies have evaluated predictive kinetics of plasma~     biomarkers and receptor for advanced glycation end products (RAGE) polymorphisms in a broad~     population of critically ill patients or as an adjunct to clinical prediction scores.~      The main objective of the investigators study is to evaluate the predictive values of plasma~     soluble RAGE levels for the onset of ARDS in a high risk population of patients admitted to~     the intensive care unit (ICU).~      One of the investigators goals is to improve early identification of patients at risk for~     ARDS in order to better implement preventive stategies prior to ARDS development.~      The primary outcome is the occurrence of ARDS during the first week after admission to the~     ICU.~   "
114364|NCT02070523|"~     To determine, compared with Daunorubicin(DNR), whether Pegylated liposomal doxorubicin (PLD)~     inducing higher complete remission (CR) rate, in untreated primary ALL adult patients with~     VDCLD regimen induction therapy. Second, to determine, compared with the DNR, whether~     chemotherapy containing PLD with a higher response rates and greater safety in adult ALL~   "
114365|NCT02070510|"~     This trial is conducted in Europe. The aim of the trial is to investigate the influence of~     oral semaglutide (NNC0113-0217) on the pharmacokinetics of lisinopril and warfarin in healthy~     subjects.~   "
114366|NCT02070497|"~     The study is to investigate the effectiveness of nursing case management for lung cancer~     patients in a Taiwan medical center.~   "
114367|NCT02070484|"~     The purpose of this study is to compare the effect and safety of NuCel to DBX on patients~     undergoing posteriolateral lumbar spinal fusions for degenerative disc disease.~   "
114368|NCT02070471|"~     Evaluate the efficacy, Safety and Pharmacokinetics of Intravenous single injection LC28-0126~     immediately before PCI (Percutaneous Coronary Intervention) in Patients with STEMI~     (ST-segment Elevation Myocardial Infarction)~   "
114369|NCT02070458|"~     This phase I trial studies the side effects and best dose of ixazomib when given in~     combination with mitoxantrone hydrochloride, etoposide, and intermediate-dose cytarabine in~     treating patients with acute myeloid leukemia that is unresponsive to initial induction~     chemotherapy or recurs following an initial complete remission. Acute myeloid leukemia is a~     cancer of the bone marrow cells; bone marrow is where blood cells are normally made. Ixazomib~     may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~     Drugs used in chemotherapy, such as mitoxantrone hydrochloride, etoposide, and~     intermediate-dose cytarabine, work in different ways to stop the growth of cancer cells,~     either by killing the cells or by stopping them from dividing. Mitoxantrone hydrochloride,~     etoposide, and intermediate-dose cytarabine are standard treatment for relapsed or refractory~     acute myeloid leukemia. Giving ixazomib with mitoxantrone hydrochloride, etoposide, and~     intermediate-dose cytarabine may improve the effectiveness of the chemotherapy.~   "
114370|NCT02070445|"~     During most types of heart surgery cardiopulmonary bypass (CPB) is used. CPB enables blood to~     be directed away from the heart and the lungs and pumped through the body while the heart is~     not beating. Surgery on the heart easier when it is not beating and bloodless area. Generally~     during CPB the lungs do not need to be ventilated, as no blood is flowing through the lungs~     and the body received oxygen from a machine (oxygenator) attached to the CPB pump.~      In this study we are investigating the difference in lung collapse after heart surgery in~     patient who did have their lungs ventilated during CPB, compared to patients who did not have~     their lungs ventilated during CPB. We will use lung ultrasound scans to determine the degree~     of lung collapse at various time periods before and after the heart surgery. We will also~     investigate if ventilation during CPB will affect: a.) the rate of lung infection or~     pneumonia after the operation b.) the time it takes for a patient to have the breathing tube~     removed in the intensive care unit after the operation c.) the time for a patient to be~     discharged home from the hospital d.) the concentration of oxygen in the blood after the~     operation.~   "
114371|NCT02070432|"~     This study will investigate the tolerability, recommended dose and pharmacokinetics of LUZ11~     following photodynamic therapy (PDT) of patients with advanced head and neck cancer.~   "
115798|NCT02051751|"~     Dose escalation part:to determine the highest dose of BYL719 administered on a daily basis~     when given in combination with weekly paclitaxel Dose escalation part: to confirm the safety~     and tolerability of the BYL719 and paclitaxel combination~   "
114372|NCT02070419|"~     This randomized phase II trial studies how well transarterial chemoembolization (TACE) works~     compared with TACE plus radiation therapy in treating patients with end stage liver disease,~     liver tumors, or potential liver transplant candidates. TACE involves reaching up to the~     blood vessel that feeds the tumor through a catheter placed into the groin vessel. Once the~     physician has defined the vessel going to the tumor, chemotherapy is infused to the tumor and~     the vessel is blocked, maintaining the chemotherapy for longer time inside the tumor and~     stopping the blood flow that feeds the tumor. Stereotactic body radiation therapy (SBRT) is a~     type of radiation therapy that delivers radiation to the tumor cells but does not harm normal~     liver cells. It is not yet known whether TACE is more effective with or without SBRT in~     treating liver tumors.~   "
114373|NCT02070406|"~     This pilot phase I trial studies the side effects of taking ipilimumab after gene-modified T~     cells and vaccine therapy when treating patients with advanced cancer that has spread to~     other areas of the body and has not responded to standard therapies. This trial also will~     determine the best dose of Ipilimumab to use in this combination treatment. T cells are a~     special type of white blood cell (immune cell) that have the ability to kill cancer cells. T~     cells are taken from the blood and modified in the laboratory to recognize a specific protein~     expressed on cancer cells, called NY-ESO-1. This may allow the T cells to target and kill~     cancer cells that express that protein. Dendritic cells are another type of blood cell that~     can teach other cells in the body to look for cancer cells and attack them. Giving a~     dendritic cell vaccine with the NY-ESO-1 protein may help dendritic cells teach the immune~     system to target cancer cells expressing that protein, and further help the T cells attack~     cancer. Ipilimumab is a monoclonal antibody, a type of drug manufactured in the laboratory~     that is similar to antibodies made in the human body that fight off infection. Ipilimumab~     blocks a protein that turns down the immune system, so blocking this protein may make the~     immune system more active. This may increase the ability of immune cells to kill cancer cells~     and improve the effectiveness of the T cell transplant. Giving gene-modified T-cells, a~     dendritic cell vaccine, and ipilimumab together may teach the immune system to recognize and~     kill cancer cells that have the NY-ESO-1 protein.~   "
114374|NCT02070393|"~     The purpose of this study is to drastically reduce unnecessary breast dose in young females~     with Hodgkin's Disease who require radiation therapy.~   "
114375|NCT02070380|"~     This study aims at a comparison between MultiHance at a dose of 0.1 mmol/kg and 0.05 mmol/kg~     and Dotarem at a dose of 0.1 mmol/kg in brain tumor patients to show superiority of~     MultiHance.~   "
114376|NCT02070367|"~     This pilot study will test a new therapy, somatosensory rehabilitation, for the painful~     sensitivity experienced by persons with nerve injuries and/or complex regional pain syndrome~     (CRPS). Several methods for measuring pain and sensitivity that emphasize the person's~     evaluation of their own symptoms and the impact of these symptoms on their daily activities~     will also be tested to make sure they are consistent and accurate.~      Previous research has suggested one of the assessments may also be used to assist in the~     identification of CRPS: this simple test will be evaluated to see if it can accurately~     identify persons with this disorder (for which there is currently no diagnostic test).~     Together, this will improve treatment of CRPS through early, accurate diagnosis and the~     ability to measure important changes in this painful condition, and set up future studies for~     this new rehabilitation treatment method.~   "
114377|NCT02070354|"~     The purpose of this research study is to determine how bariatric surgery affects physical~     activity and nutrient intake.~      This research study is being done because the investigators want to determine better~     recommendations to provide to bariatric surgery patients.~   "
114378|NCT02070341|"~     Introduction: Colonoscopy is an important tool for colon cancer screening. Proper colon~     cleansing is essential to ensure adequate mucosal examination. Timing of bowel preparation~     administration is now recognized as an important component for achieving superior cleansing.~     Multiple randomized controlled trials and meta-analyses have found split-dosing to be~     superior than day-before dosing. Objective: This study aims to compare two types of bowel~     preparations in split-doses to assess for differences in patient tolerability, as well as~     efficacy of colon cleansing. Methods: This is a prospective, single-blinded,~     randomized-controlled trial. Patients who are being referred for a colonoscopy will be~     recruited to participate in the study. They will be randomly assigned to receive either a~     split-dose polyethylene glycol (PEG) or picosalax (P/MC) bowel preparation. Patient~     tolerability will be examined through questionnaires. The endoscopist performing the~     colonoscopy will use two standardized bowel preparation scoring systems to evaluate the~     quality of the cleansing. The investigators propose that P/MC will be superior to PEG in~     patient tolerability and non-inferior in bowel cleansing effects.~   "
114379|NCT02070328|"~     Proton therapy is a limited medical resource that is more expensive than conventional x-ray~     therapy. To correctly measure the success of proton therapy in treating different conditions,~     it is important to check a patient's health status after their treatment is finished.~     Checking on the progress of patients over many years (called long-term follow-up) is needed~     because the long-term effects of proton therapy are not well known.~   "
114380|NCT02070315|"~     Liver biopsy for the assessment of fibrosis has multiple limitations. Liver ShearWaveTM~     Elastography may provide a non-invasive, fast, and reproducible alternative for the~     quantitative assessment of liver fibrosis.~   "
114381|NCT02070302|"~     This study will be a prospective double blind controlled randomized trial of ten patients~     diagnosed with Carpal Tunnel Syndrome (CTS). The study will be completed at offices of~     medical practices in Arizona. Patients who meet inclusion criteria will be randomly~     distributed into two groups: a BOTOX® (onabotulinumtoxin A) injection group and a Normal~     Saline Injection (NS) (Placebo group). Each group will consist of five randomly assigned~     individuals.~   "
114382|NCT02070289|"~     The purpose of this study is to investigate safety, toleration and time course of plasma~     concentration of multiple oral doses of PF-06372865 for 14 days in healthy subjects of two~     age groups, 18-55 years (Group 1) and 56-75 years (Group 2).~   "
114392|NCT02070159|"~     Although prasugrel, recently available thienopyridine derivative, exhibits rapid and potent~     platelet inhibition, concerns of low on-treatment platelet reactivity have been suggested~     especially in East Asian ethnicities. The investigators compared the effect of lower loading~     dose of prasugrel with conventional loading dose of clopidogrel and prasugrel.~   "
114383|NCT02070276|"~     Spinal anesthesia is still the regional anesthesia technique most widely employed in everyday~     clinical practice.~      The most feared and common of its well known side effects consist in an abrupt reduction of~     systemic vascular resistances, with consequence risk of systemic hypotension. To prevent this~     potentially severe complication, an adequate correction of patients' volume status through a~     preventive administration of fluids is widely used.~      However this volume repletion is commonly accomplished on an empirical basis, without having~     a real insight of patient hemodynamic status, carrying the risk of possible volume overload.~      Aim of the study is to test the clinical impact of two simple, non-invasive methods to guide~     volemic repletion before spinal anesthesia on the reduction of significant hypotension rate,~     compared to empirical fluid administration.~   "
114384|NCT02070263|"~     The purpose of this prospective study is twofold: 1) to establish oral tolerance to selected~     tree nuts and to examine potential predictors of oral tolerance and 2) to determine the~     usefulness of mixed tree nut allergen food challenges in more efficiently defining tree nut~     allergy and oral tolerance.~   "
114385|NCT02070250|"~     Psychological interventions for cancer patients have been tested and found to reduce stress~     and improve quality of life. These interventions have been tested at academic medical centers~     but have not been available for use by community mental health professionals. One such~     intervention is the Biobehavioral Intervention (BBI), developed by Professor Barbara L.~     Andersen and colleagues at Ohio State (OSU). Current funding has enabled the investigators to~     train mental health professionals from across the country to deliver the BBI at their~     institution. Recently diagnosed cancer patients who are participating in the BBI group at~     these institutions may participate in a research study completing self report measures asking~     about psychological and behavioral outcomes (for example, mood, stress, diet and physical~     activity). The investigators hypothesize that individuals participating in the intervention~     will report improvements in outcomes, such as reduced stress and improved mood, reduced~     symptoms of the disease and treatment, etc., after completing the intervention and continue~     to report these improvements up to 6 months after the group ends. OSU will coordinate this~     data collection project but information about participating sites is listed in~     http://clinicaltrials.gov.~   "
114386|NCT02070237|"~     Pregnant and recently postpartum women are at significantly higher risk of developing a blood~     clot in their arms or legs known as a deep venous thrombosis (DVT) and/or a blood clot in~     their lungs known as a pulmonary embolism (PE) compared to their non pregnant counterparts.~     It is estimated that this risk increases anywhere from 4 to 50 times higher in pregnant~     versus non-pregnant women and further increases almost 11 fold in the post partum period.~     This risk is almost doubled when the patient undergoes cesarean delivery. In 2011, the~     American College of Obstetricians and Gynecologists (ACOG) issued updated guidelines stating~     that for patients undergoing cesarean delivery with additional risk factors for clot or~     thromboembolism, protective (prophylactic) treatment with low molecular weight heparin (LMWH)~     a type of blood thinner should be considered. However, no specific guidelines about which~     risk factors should be considered, or what medication doses should be used were provided. The~     American College of Chest Physicians (ACCP) Evidence-Based Clinical Practice Guidelines~     published in 2012 delineated who should be given prophylaxis based on various risk factors,~     however acknowledged that the recommendations were based on weak quality evidence.~      ACOG endorses either once or twice a day dosing for high risk patients after delivery and~     states that adjustments for obese women should be made on a case by case basis. However,~     there are limited studies on the dosing of LMWH in specific subpopulations including post~     operative patients, pregnant patients and obese patients. All of these studies have urged~     further investigation of the correct dosing for these high risk subjects due to changes~     associated with pregnancy and the level of medication in the blood that may put these~     patients at higher risk of venous thromboembolism. Many previous studies have shown that~     women in these high risk categories do not achieve protective levels of the medication~     measured with a laboratory test; anti Xa level. The investigators hypothesize that due to~     their dual risk, obese post-operative recently pregnant women may not be adequately protected~     with the daily fixed dose and might need more frequent dosing to protect them.~      The objective of this study is to assess what proportion of women achieve the desired anti Xa~     level with the fixed daily dose versus twice daily weight based dosing (0.5 mg/kg).~   "
114387|NCT02070224|"~     The purposes of this study are to assess the prognostic value of serum and urinary biomarkers~     Coll2-1 and Coll2-1NO2 at baseline, and their change over the first year, on the progression~     of knee osteoarthritis MRI scores at 12 months, on the progression of knee osteoarthritis~     clinical score at 12 months. Additionally, this study will search for correlations between~     serum and urinary biomarkers Coll2-1 and Coll2-1NO2 at baseline with the radiographic, MRI~     and clinical severity of knee osteoarthritis.~   "
114388|NCT02070211|"~     The purpose of the present trial is to investigate the effects of omega-3 PUFAs in~     individuals aged 12-26 years with 22q11DS at ultra-high risk for developing a first episode~     of psychosis.~   "
114389|NCT02070198|"~     Despite the progression in assisted reproductive technology (ART), poor ovarian response to~     controlled ovarian stimulation remains a challenge for clinicians and a source of distress~     for patients. Multiple strategies have been tried to overcome these obstacles. The increase~     of the gonadotropin administration have been associated with a very low pregnancy rate. The~     introduction of GnRH agonist protocol, which takes advantage of the initial rise in~     endogenous gonadotropins that follows the agonist administration in the early follicular~     phase and subsequently prevents a premature LH surge, with fewer cycle cancellations, have~     improved cycle parameters and increased pregnancy rate. Recently, GnRH antagonists were~     introduced in ART treatment. They are effective in preventing a premature LH surge and allow~     for a more natural recruitment of follicles in the follicular phase in a non suppressed~     ovary. However, the randomized studies comparing the efficacy of these two regimens reported~     conflicting and nonsignificant results. Moreover, more recently adjuvant therapies for COH~     such as growth hormone therapy or pyridostigmine, oral L-arginine, and transdermal~     testosterone failed to improve IVF outcomes. Recently, the new treatment option with~     corifollitropin alfa, able to keep the circulating FSH level above the threshold necessary to~     support multi-follicular growth for an entire week, in a GnRH antagonist protocol seems to~     have a potential beneficial effect in poor responders.~      The aim of this study is to compare long-acting FSH/GnRH antagonist with daily FSH/GnRH~     antagonist with short GnRH agonist protocol on IVF outcome in poor responder patients .~   "
114390|NCT02070185|"~     The main objective is to study, in 8-11 year old children, the influence of energy density~     conditioning on liking for new flavored beverages and on caloric adjustment after the~     beverage consumption. The stability of the energy conditioning was evaluated after a period~     without exposure and after an extinction period during which the energy density of the~     beverages was changed.~   "
114391|NCT02070172|"~     Motion limitations have been previously reported in people with headaches originating from~     the neck/cervicogenic headaches. A test involving flexing and rotating the neck has been~     found useful to diagnose this type of headache. This observational study investigates this~     neck motion test when performed actively by the patient and passively by the examiner, then~     compares the results of motion attained.~   "
114393|NCT02070146|"~     Survival after colorectal cancer (CRC) diagnosis strongly depends on local tumor extent,~     lymph node involvement and the presence of distant metastases. However, there remains great~     inter-patient variability regarding treatment outcome. A combination of biochemical factors,~     histopathological features, genomic profile, environmental factors and other clinical factors~     are likely to influence prognosis and treatment effect, independent from tumor stage, but it~     is still unclear which, how, and to what extent these factors can influence tumor recurrence~     and mortality in both early stage (I-III) and late stage (IV) CRC.~      Although the results from prospective clinical trials will remain the backbone of evidence~     based medicine, this concerns a highly selected patient population since the large majority~     (85%-95%) of cancer patients do not participate in clinical trials for various reasons. It is~     unlikely that trial participation will significantly improve in the near future. This fact~     has the following implications: 1) It is highly desirable to validate the results from trials~     in the general patient population. However, this is complicated by the fact that the~     documentation of patients treated in general practice (i.e. outside the scope of clinical~     trials) is largely insufficient to provide comparable patient cohorts in terms of prognostic~     characteristics and treatment parameters. 2) There is an increased availability of novel~     technologies that provide molecular markers with potential prognostic and/or predictive~     value. To test the clinical value of these markers large numbers of patients are required~     which greatly exceeds the number of patients who consent to participate in prospective~     clinical trials. 3) as a result of rapid technical developments, a range of new minimally~     invasive treatment options for CRC are entering the market. These interventions have the~     potential to be of great benefit for patients in terms of improved local control, higher~     probability of complete tumor removal, less damage to surrounding tissue, faster recovery and~     less short and long term side effects. Still, the interventions will have to prove their~     effectiveness, safety and superiority (or non-inferiority) to standard cancer treatments on a~     patient level. A prospective observational cohort study has the great opportunity to fill~     this gap.~   "
114394|NCT02070133|"~     To evaluate in patients with stable Chronic Obstructive Pulmonary Disease (COPD) the efficacy~     of statins (simvastatin) on: (1) endothelial function; (2) systemic inflammation; (3)BODE (B:~     body mass , O: bronchial obstruction, D: dyspnea and, E: exercise tolerance) index; (4) Uric~     acid; and, (5)vascular growth factors. Design: a 12 weeks randomized (1:1), double-blind,~     placebo control study. Population: 18 males with stable COPD between 40-80 years of age,~     exsmokers, with Forced expiratory volume in one second (FEV1) between 30 and 80% predicted~     post-bronchodilation.~   "
114395|NCT02070120|"~     Patients diagnosed with low risk non-muscle invasive bladder cancer (NMIBC) are at risk of~     frequent low grade recurrence, which usually necessitates surgical intervention under general~     anaesthetic. This multicentre study aims to establish the short term efficacy of~     chemoresection using chemotherapy within the bladder for the treatment of NMIBC.~      Should the levels of complete response following chemoresection meet predefined criteria, a~     larger phase III trial would be developed to assess longer term disease related endpoints,~     with the aim of standardising management of recurrent low risk NMIBC and potentially removing~     the need for over a thousand patients each year to undergo surgery.~   "
114396|NCT02070107|"~     No more than 56% of subjects at the Robley Rex Louisville Veterans Administration Medical~     Center (VAMC) prescribed boceprevir-based triple therapy, will complete Hepatitis C (HCV)~     treatment as prescribed. Of patients who did not complete therapy, the primary reasons for~     discontinuation were side effects (48%) and non-adherence (32%). An intervention is needed to~     improve the treatment completion rate in subjects so they can achieve the high SVR rates~     noted in SPRINT-2 and RESPOND-2~   "
114397|NCT02070081|"~     The overall aim is to study the multiple factors determining the variation of weight loss~     after Roux-en-Y Gastric Bypass (RYGB) and Sleeve surgery.~      The specific aims are to evaluate:~      a) what explains the large individual differences in weight loss seen after RYGB and Sleeve~     surgery, b) if it is possible pre-operatively to identify which patients will not obtain~     beneficial effects of bariatric surgery in relation to weight loss and quality of life and c)~     if patients in need of improved care can be identified pre- and/or early post-operatively.~   "
114398|NCT02070068|"~     Operations on the liver, bile ducts, and gallbladders are some of the most commonly performed~     abdominal operations in the United States. Cholecystectomy, removal of the gallbladder, is~     the most common of these with more than 750,000 performed annually. Injury to the common bile~     duct (CBD) during these procedures occur infrequently (approximately 0.1% to 0.5%), but it is~     an important source of patient morbidity. Serious injuries often require at least one~     surgical repair, and these repairs have variable long-term outcomes. Techniques to allow the~     visualization of the bile ducts may prevent such an injury, by providing vital information~     about the presence of gallstones in the CBD and show a surgical road map of the ducts.~     Near-infrared (NIR) cholangiography has the advantage over standard cholangiography of not~     exposing patients and healthcare providers to radiation. This technique also allows the~     superimposition of the cholangiogram onto the normal image.~      This study is being conducted to optimize an imaging technique called PINPOINT. Images will~     be obtained during clinically necessary operations. The images will be evaluated to determine~     the best method for locating and outlining the anatomy. The information learned will guide~     the future use of PINPOINT in laparoscopic procedures.~   "
114399|NCT02070055|"~     There is a large variability in people's ability to burn fat during exercise. It is thought~     that differences in dietary intake can partly explain this variation, however this has not~     been comprehensively studied. This will be investigated by measuring participant's habitual~     diet and rates of fat oxidation during exercise, and look for associations between the two.~   "
114400|NCT02070042|"~     We aim to evaluate whether the addition of Omega-3 fatty acids to oxybutynin, a standard~     first-line treatment for overactive bladder syndrome, will improve symptoms and quality of~     life. Secondarily, we will evaluate whether Omega-3 fatty acids help reduce the adverse~     effects of oxybutynin.~      Hypothesis~        -  Primary: Omega-3 will enhance the beneficial role of oxybutynin in the treatment of~          overactive bladder (OAB)~        -  Secondary: Omega-3 will reduce the side effects of dry eyes and constipation associated~          with oxybutynin~   "
114401|NCT02070029|"~     Female Sexual Dysfunction (FSD) affects up to 43% of women in the United States and~     Hypoactive Sexual Desire Disorder (HSDD) is the most common form. There is no standardized~     treatment for this condition. We know that alternative therapies such as acupuncture have~     been beneficial to women suffering from urinary incontinence, chronic lower back pain, and~     migraines. We hypothesize that the quality of life for premenopausal women with hypoactive~     sexual desire disorder (HSDD) will improve with initiation of acupuncture therapy for a~     duration of 5-weeks. Validated questionnaires are administered at the time of enrollment and~     1 week after the final acupuncture session as the method of analyzing our primary outcome.~   "
114439|NCT02069535|"~     This trial is an open, national, multi-centre trial. The main objective of this trial is to~     assess the tolerability of the up-dosing phase of AVANZ® Cupressus arizonica by measurement~     of related Adverse Events.~   "
114402|NCT02070016|"~     The purpose of this study is to test whether non-invasive brain stimulation, such as~     Transcranial Magnetic Stimulation (TMS) may alleviate pain associated with various chronic~     pain conditions. We will test various methods of TMS to identify a treatment approach that~     may reduce the symptoms of chronic pain for the patient.~   "
114403|NCT02070003|"~     The investigators aim to characterize the relationship between changes in emotional distress,~     opioid use, and pain throughout surgery and recovery. Additionally, the investigators aim to~     compare the effectiveness of post-surgical motivational interviewing and physician-guided~     opioid weaning vs. usual care on reducing persistent opioid use. Overall, the proposed~     research will advance knowledge regarding the role of psychological factors contributing to~     persistent opioid use after surgery.~   "
114404|NCT02069990|"~     Circa-annual variations in 25-hydroxyvitamin D [25(OH)D] levels have been well established,~     and there also seems to be an effect of season on bone turnover and bone mass. been shown~     that bone turnover follows a circa-annual rhythm. On the basis of human clinical results, it~     was suggested that adipose tissue functions as a vitamin D buffering system that to a certain~     extent prevents uncontrolled synthesis of 25(OH)D in the liver. Directly related to this~     issue is the question of how much vitamin D is needed to ensure target serum~     25-hydroxyvitamin D [25(OH)D] concentrations. According to the recommended dietary~     allowances, persons should achieve levels of intake of essential nutrients considered to be~     adequate to meet the known nutritional needs of practically all healthy persons Moreover it~     is important to note that the significant percentage of the population is temporarily of~     continuously deficient in vitamin D. In the similar condition of vitamin D deficiency, the~     aetiology is very different since only as almost exclusively as a consequence of a primary~     disease in children it is manifested: hypovitaminosis D is highly prevalent among children on~     renal substitution therapy, regardless of the type of therapy used and the stage of renal~     failure.~      The rationale providing high dose strengths of vitamin D based on an assumption of better~     compliance especially in adult with senior age patients; also a potential for faster~     resolution of vitamin D deficiency, since utilization of cholecalciferol is higher when~     patients had low levels of 25(OH)D, and vice versa, there is a plateau phase when close to~     normal range (Vieth 2001).~      According to clinical data, a doses equivalent of daily 1000 IU, (7000 IU per week, or 30000~     IU per month) is considered as a minimal effective dose to treat vitamin D deficiency. The~     treatment of vitamin D with a duration of 30 days may result and increase of 6-12.5 nmol/L.~     With the deficiency criteria considered as <20 ng/ml, the vitamin supplementation is~     indicative, the treatment dosages should be adjusted to the increase planned to achieve the~     mid-normal range.~      As the base of calculations, the doses of 40 IU results in an increase of 0.4 ng/ml in a~     period of 60 days. Accordingly 1000 IU in a period of 2-5 month resulted in an increase of~     approx 10 ng/ml. The risk of overdose in relatively low, since the absorption and the~     metabolic path is well controlled: automatic mechanisms downregulation at normal ranges.~      In this study the there are three groups in the similar daily dose equivalent of 1000 IU/day.~     The absorption of daily , weekly and monthly dosing should have a buffered effect due to the~     body adipose tissues, balancing the daily 1,25(OH)D levels, and moreover to provide a~     biological reservoir. The three doses are considered as comparable in efficacy and safety.~      The fourth group is intended to utilize the expanded dose range of 4286 IU/ day, using the~     30.000 IU tablets on a weekly dosing schedule. This group is to demonstrate the efficacy of~     higher doses to normalize the vitamin D levels, within a reasonable timeframe of 60-90 days.~   "
114405|NCT02069977|"~     -  To evaluate the efficacy of flexibly dosed aripiprazole in reducing serious behavioral~          problems in Asian children and adolescents with a diagnosis of autism spectrum disorder,~          as measured by change from baseline to endpoint on the irritability subscale of the~          aberrant behavior checklist (ABC-I).~        -  To evaluate the long-term safety and tolerability of flexibly dosed aripiprazole in the~          treatment of serious behavioral problems in Asian children and adolescents with a~          diagnosis of autism spectrum disorder.~   "
114406|NCT02069964|"~     Some patients with head and neck cancer or benign tumours of the head and neck receive~     radiotherapy to their neck as part of their treatment. The large arteries in the neck, the~     carotid arteries, are often included in the area being treated with radiotherapy. There is~     some evidence to show that radiotherapy to these blood vessels can result in thickening and~     furring of the artery walls some years after treatment. This thickening may then result in~     stiffening and narrowing of the artery.~      Current research is now aimed towards detecting radiotherapy-related changes to the carotid~     arteries at an earlier stage and towards using new radiotherapy techniques to avoid treating~     these blood vessels if possible. The question of whether or not the use of preventive~     medicines like aspirin and cholesterol-lowering tablets helps to reverse this process is~     currently unanswered.~      The aim of this study is to compare the thickness (intima-medial thickness) of the carotid~     artery wall over time (a period of 5 years) following radiotherapy to the thickness in~     carotid arteries that have not received radiotherapy. There are many other causes for~     thickening of arteries (such as high blood pressure, high cholesterol levels and diabetes)~     and these may affect the ability to measure the effect of radiotherapy change to the artery~     wall. In order to address this, it is ideal to look at this process in patients who are~     having only one side of the neck treated and use the other side as a comparison. The study~     will also be investigating for earlier signs of radiotherapy-related changes, such as~     stiffening of the artery wall, inflammation in the artery wall (a very early sign of~     radiotherapy-related change) and some markers in the blood that may indicate that this~     process is taking place.~      The null hypotheses of this study are:~        -  In irradiated carotid arteries, mean intimal-medial thickness at one year following~          radiotherapy will be the same as in unirradiated arteries.~        -  The incidence of carotid artery stenosis will be the same in irradiated and unirradiated~          carotid arteries~        -  Arterial wall strain at one year following radiotherapy will be the same in irradiated~          and unirradiated carotid arteries.~        -  Microbubble ultrasound will not be able to detect Inflammation in the carotid arteries~          during radiotherapy as an early marker of atherosclerosis; microbubble ultrasound will~          not demonstrate at what dose of radiotherapy inflammation begins.~        -  Serum biomarker levels will not increase over time from baseline after radiotherapy and~          won't correlate to IMT and arterial strain.~   "
114407|NCT02069951|"~     Surgical training programs using virtual reality simulators often only use basic skills~     training and the use of procedural training is very limited. Procedural training differs from~     basic skills training by requiring integration of isolated skills and decision making and~     planning components. However, it is unknown if it is necessary to practice all procedures~     before operating on actual patients or whether it is simply a matter of learning psychomotor~     skills and if these skills are transferable between different tasks.~      The main hypothesis is that practicing a laparoscopic procedure on a simulator makes it~     easier to reach proficiency on a different laparoscopic procedure on the simulator because~     participants have already practiced the integration of isolated skills.~   "
114408|NCT02069938|"~     Noninvasive Brain-Computer Interfaces (BCIs) have been used to control a number of virtual~     and physical objects through the voluntary modulation of brain rhythms. Current issues with~     noninvasive BCIs include exhausting motor imagery tasks and long training times required to~     achieve competent control. The investigators will address these issues within this protocol,~     examining new approaches to reduce the effort required by subjects to control a physical~     object in the task.~      The PI's hypothesis is: Control of a physical robotic device will increase the performance of~     subjects in BCI tasks that are analogous to virtual tasks due to greater engagement with a~     physical output.~   "
114409|NCT02069925|"~     The guiding questions for this study are: can a U.S. adaptation of a successful Scandinavian~     approach (TIPS) to early detection substantially reduce the duration of untreated psychosis~     (DUP) and improve outcomes beyond an established first-episode service (FES)?~      The primary aim of this study is:~        1. To determine whether an early detection intervention can reduce DUP in the US, as~          compared to usual detection. Early detection (ED) will be implemented in one US~          community (New Haven, CT), and usual detection efforts will continue in another (Boston,~          MA). DUP will be measured at admission to the corresponding first-episode services (STEP~          & PREP) in each community, over one year before and throughout ED implementation. The~          investigators hypothesize that DUP will be reduced significantly in the early detection~          site compared to the usual detection site;~        2. A secondary aim is to determine whether DUP reduction can augment the outcomes of~          established FES on outcomes in the U.S. The investigators will measure symptoms,~          functioning and engagement with treatment at entry and over 1 year at each site. The~          investigators hypothesize that shorter DUP at one FES (STEP) will predict reduced~          distress and illness severity at entry and better early outcomes at STEP compared to~          PREP.~   "
114410|NCT02069912|"~     1. Implement an evidence-based structured care approach that includes screening; acute~          treatment and relapse prevention follow-up tailored for public sector clinics and~          low-income and minority patients.~        2. Adapt an evidence-based collaborative care model for primary care, implement the adapted~          model, evaluate and further refine the model based on the pilot experience, and produce~          and disseminate a detailed manual for use in public sector clinics.~        3. Evaluate Multifaceted Depression and Cardiovascular Program (MDCP) in an open trial to~          determine: its acceptance by patients, medical providers, and organizational~          decision-makers; patient depression treatment adherence; its direct cost; and the size~          and variability of change from baseline in the primary outcome measures: depressive~          symptoms, functional status, quality of life, health service use, and cardiac status at~          6 and 12 month follow-up.~   "
114411|NCT02069899|"~     International, multicenter, long-term, follow-up study that will enroll HLH patients who have~     received NI-0501 in a previous clinical trial, in the context of the clinical development~     program for NI-0501~   "
114440|NCT02069522|"~     This is a prospective, double blind, crossover study in healthy infants randomized to one of~     two study formulas. The trial will consist of two 21 day study feeding periods separated by a~     study washout period.~   "
114412|NCT02069886|"~     The CENTAurus trial is a prospective clinical study designed to address systematically some~     of the relevant endocrine complications in an iron overloaded thalassemic population, primary~     objective being the assessment of the effect of deferasirox therapy on glucose~     metabolism/homeostasis. Other endocrine parameters complementary or supportive to the primary~     objective will be assessed and analyzed during this study. A number of lab parameters related~     to other axes of the endocrine system will be collected and analyzed.~   "
114413|NCT02069873|"~     The purpose of the study is to evaluate the efficacy of a group protocol for the delivery of~     evidence-based therapies in comparison to a wait-list control and evaluate the relative~     contribution of exposure, cognitive, and skills blocks of treatment in a 16-session~     manualized group treatment protocol in a sample of OIF/OEF female PTSD veterans. Hyp1:~     Overall improvement is expected in PTSD symptoms compared to a wait-list control group; and~     Hyp2: the exposure and cognitive components are expected to show greater improvement in PTSD~     symptoms than the skills component. Significant results will establish the efficacy of a~     group format for evidence-based treatments for all veterans with a PTSD diagnosis. An~     ancillary part of the study is to examine initial neuropsychological presentation in this~     population and possible changes that may occur as the result of treatment.~   "
114414|NCT02069860|"~     A Bone Anchored Port System (BAP) will be implanted in the mastoid bone behind the ear,~     connected with a double lumen central venous catheter inserted in the jugular vein, and will~     be used in conjunction with an adapter as a permanent vascular access for hemodialysis~     treatment.~   "
114415|NCT02069847|"~     Surgery has been historically the mainstay treatment for advanced pre-malignant lesions and~     early esophageal cancers. However, esophagectomy is associated with significant morbidity and~     mortality. With the advance of therapeutic endoscopy, there has been a growing interest and~     application of endoscopic resection and mucosal ablative techniques for the treatment of~     these diseases. Esophageal stricture (ES) formation has become an increasingly recognized~     complication of extensive endoscopic mucosal ablation and/or resection. The resultant~     symptomatic stricture development can significantly impair a patient's quality of life.~     Endoscopic therapy of esophageal strictures with balloon dilation and/or local steroid~     injection is invasive, costly, and associated with the potential risk of perforation.~     Recently, oral corticosteroids have been introduced for the prevention of esophageal~     stricture after endoscopic submucosal dissection.~      Budesonide is a synthetic steroid with topical anti-inflammatory properties and high~     first-pass metabolism; thus, potentially less systemic absorption and side effects.~      Hypothesis: Oral budesonide prevents esophageal stricture formation in patients who underwent~     radical endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) for~     advanced premalignant esophageal lesions or superficial esophageal cancers.~   "
114416|NCT02069834|"~     The primary objective of the study is to evaluate the capacity of Dolutegravir + Rilpivirine~     vs. continued triple combination HAART to maintain plasma HIV RNA ≤ 50 copies/ml throughout~     24 weeks in patients with plasma HIV RNA ≤ 50 copies/mL for at least 2 years under~     conventional HAART (2 NNRTI + 3rd agent).~      The main secondary objectives are the following:~        -  % of virologic success (plasma viral load ≤ 50 copies/mL) at W24 and W48~        -  % of patients who maintain a plasma viral load ≤ 50 copies / ml from D0 to W48~        -  % of virological failure defined by two consecutive plasma viral load > 50 copies/mL~        -  Profile of genotypic resistance in case of virological failure.~      The trial will be conducted according to the design below, in 3 steps:~        -  Step 1: enrollment of 80 patients (40 in each arm)~        -  Step 2: enrollment on hold until W16 data from the 40 patients enrolled in the~          intervention arm have been analyzed.~        -  Step 3: resumption and completion of enrollment if conditions for resuming enrollment at~          the end of step 2 are fulfilled, i.e. if the percentage of patients randomized to the~          intervention arm who have a plasma viral load ≤ 50 copies/mL from D0 to W16 is~          significantly > 70%, which translates in a maximum of 6 virologic failures.~   "
114417|NCT02069821|"~     The purpose of the study is to assess the pharmacokinetic interactions between amlodipine~     besylate/valsartan and atorvastatin single or co-administered in healthy volunteers.~   "
114418|NCT02069808|"~     Disprove the null hypothesis as follows:~      Among the investigator's egg bank donors undergoing ovulation induction with recombinant FSH~     medication per treatment protocol outlined below, use of adjunctive LH activity medication~     Menopur ™ , will result in the same number of mature oocytes recovered and cryopreserved as~     from egg donors not treated with Menopur™.~      Objectives:~      Compare efficacy of recombinant FSH (Follistim ™) with and without adjunct LH activity~     medication Menopur ™ for our volunteer egg bank donors.~      Efficacy defined as:~        1. #Days of ovarian stimulation to GnRH agonist trigger.~        2. Peak serum estradiol level on day of GnRH agonist trigger.~        3. Number of follicles >15 mm average diameter on day of GnRH agonist trigger.~        4. Number of mature oocytes recovered and cryopreserved.~      Study type: Randomized prospective clinical trial.~      Patient selection: Voluntary egg donors who have satisfied all screening criteria for FDA and~     the Michigan Egg Bank: Age range 18-to 39 years. BMI 18 to 25. Resting antral follicle count~     of 16 or greater. Cycle day 3 FSH <10 mIU/ml. AMH >2.0 ng/ml.~      Study design:~      Two groups- Group A- Recombinant FSH Follistim only; Group B- Recombinant FSH Follistim and~     adjunct Menopur. Both groups will use GnRH agonist trigger 36 hours prior to egg retrieval.~      Random number generator with patients assigned basd on odd or even numbers.~      Number of subjects: 25 in each group. Total of 50 subjects. This takes into account possible~     cycle cancellation for poor ovarian response or patient elective withdrawal to result in at~     least 20 subjects in each group completing the study.~      Primary measure of outcome: number of mature oocytes recovered and cryopreserved.~      Secondary measures of outcome:~        1. #Days of ovarian stimulation to GnRH agonist trigger.~        2. Peak serum estradiol level on day of GnRH agonist trigger.~        3. Number of follicles >15 mm average diameter on day of GnRH agonist trigger.~   "
114419|NCT02069795|"~     The waveform assessment of an athlete's speech production has a high probability of showing~     abnormalities after brain injury (concussions) which could be used not only for diagnosis of~     the concussion, but for recovery of the brain. The aim of this study is to investigate this~     possibility using the Cobweb automated application system for acoustic processing.~   "
114441|NCT02069509|"~     This is a multi-centre, multi-national, prospective, observational study of Friedreich's~     Ataxia (FRDA) with a control group to:~        -  obtain natural history data on individuals affected by FRDA~        -  relate clinical assessments and results from proteomic analyses~        -  expedite identification and recruitment of participants for clinical trials~        -  develop and validate sensitive and reliable outcome measures for detecting onset and~          change over the natural course of FRDA which may also be potential outcome measures for~          use in future clinical trials and clinical care~        -  plan for future research studies~   "
114442|NCT02069496|"~     This post-marketing surveillance study is designed to collect safety information such as~     post-vaccination adverse events and adverse reactions from recipients of Arepanrix® (H1N1)~     Intramuscular Injection.~      The following items will be investigated as priority investigation items. <Priority~     investigation items>~        1. Allergic reactions~        2. Anaphylaxis~   "
114420|NCT02069782|"~     MIHOPE is a multi-state study of home visiting programs authorized under the Maternal,~     Infant, and Early Childhood Home Visiting (MIECHV) program. The study is required by the~     federal Patient Protection and Affordable Care Act of 2010 (ACA), which created the MIECHV~     program. It is being conducted by MDRC under contract to the Administration for Children and~     Families within the US Department of Health and Human Services. In conducting the research,~     MDRC has subcontracted portions of the research to Mathematica Policy Research, Johns Hopkins~     University, Columbia University, University of Georgia, and James Bell Associates.~      MIHOPE is seeking to randomly assign about 4300 families nationally to home visiting services~     or to a comparison group that will receive referrals to other services in the community. The~     study is seeking to include 88 local home visiting programs (sites) that are funded through~     MIECHV in approximately 12 states. In Washington, the study plans to randomly assign~     approximately 360 families across 6 home visiting program sites. Data will be collected from~     families, local home visiting programs, and state and federal administrative data systems to~     assess the effects of the programs on family outcomes and to learn more about how the~     programs are run. Sites included in the evaluation will be using one of four national service~     models (Nurse Family Partnership, Healthy Families America, Parents as Teachers, and Early~     Head Start—Home Visiting Option) that states have chosen for most of their MIECHV funding.~     MIHOPE will inform the federal government about the effectiveness of the MIECHV program in~     its first few years of operation, and it will provide information to help states develop and~     strengthen home visiting programs in the future. Research findings will be disseminated~     through a report to Congress in 2015; reports on program impacts, implementation, and on the~     relationship between program features and program impacts; journal articles; and practitioner~     briefs.~   "
114421|NCT02069769|"~     The goal of this study is to determine if scheduled communication with the oncology team~     through phone calls is helpful to caregivers with the transition to hospice care.~   "
114422|NCT02069756|"~     DuchenneConnect is an online, patient-report registry for individuals with Duchenne and~     Becker muscular dystrophy and carrier females. The purpose of DuchenneConnect is to connect~     Duchenne and Becker patients with actively recruiting clinical trials and research studies,~     and to educate patients and families about Duchenne and Becker care and research. At the same~     time, DuchenneConnect is a valuable resource for clinicians and researchers in academia and~     industry, allowing access to a de-identified, aggregate dataset provided by patients and~     their families—information that is vital to advances in the care and treatment of Duchenne.~     DuchenneConnect is a member of PCORnet, the National Patient-Centered Clinical Research~     Network.~   "
114423|NCT02069743|"~     The investigators have developed a mobile application (for use on smart phones) to help~     cancer patients better manage cancer pain. This study is a randomized controlled trial to~     evaluate the effect of this mobile-based intervention. The investigators' hypothesis is that~     subjects randomized to the intervention group will achieve greater reductions in~     cancer-related pain and improved quality of life.~   "
114424|NCT02069730|"~     This is a study of select drug therapies in patients with salivary gland cancer. The study~     has two phases: a molecular profiling phase (phase 1) and a treatment phase (phase 2).~      In molecular profiling phase of the study, participants will provide a sample of their tumor~     tissue to test for changes in certain genes that show whether certain drug treatments will be~     more useful than others.~      Once participants have undergone molecular profiling, they will be offered a drug treatment~     depending on the results. Certain drug treatments are designed to target certain gene~     changes. If there is a matching drug treatment, participants will be offered that treatment~     (either outside a clinical trial or within a clinical trial). If there are no gene changes or~     there are changes to genes were there are no drug treatments available for those certain~     changes, participants will be offered the study drug, Selinexor.~      Cancer is the uncontrolled growth of cells. Research shows that one way cancer cells can grow~     uncontrollably is when certain proteins, called exporter proteins, are present in high levels~     in the body. These proteins prevent certain other proteins important in protecting cells from~     becoming cancerous and important in the controlling the growth of cells, from working. The~     study drug Selinexor is new class of drug called Selective Inhibitor of Nuclear Export (SINE)~     that blocks the exporter proteins from working which may allow the other proteins to work and~     slow or stop tumors from growing.~   "
114425|NCT02069717|"~     The purpose of this study was to assess the incidence rate of the major adverse~     cardiovascular events (MACE) and safety of fenofibrate (Lipilfen capsule) add-on statin~     therapy in patients who have history of acute myocardial infarction and are diagnosed with~     metabolic syndrome.~   "
114426|NCT02069704|"~     This is a multicenter, open label, randomized bioequivalence study of BEVZ92 (bevacizumab~     biosimilar) and Avastin® with 2 parallel arms to compare the PK profile of BEVZ92 and~     Avastin® in combination with FOLFOX (any) or FOLFIRI chemotherapy.~      FOLFOX (any) or FOLFIRI will be chosen as per investigator criteria based on the hospital~     standard of care.~   "
114427|NCT02069691|"~     Background: Hemiplegia is one of the main reasons why stroke survivors lose their walking and~     balancing ability. Many studies point out that cycling is an effective means for lower limb~     rehabilitation. However, during training, the unaffected limb may compensate for the affected~     one resulting in suboptimal rehabilitation. To address this issue, the investigators~     developed the virtual reality-cycling training system (VRCTS) which can acquire force and~     speed signals in real-time through a cycling module. The system then analyzes the acquired~     data and uses a 3D VR rehabilitation program to help patients to train their affected side.~     The aim of the study was to develop the VRCTS, verify its function and test system function~     on both normal subjects and stroke patients.~      Methods: In this system, the investigators designed a cycling device that is embedded with~     load cell and encoder sensors to detect cycling force and angle in real-time. A Cycling Graph~     User Interface Control and Data Recode System (Cycling CR System) was applied for signal~     analysis and feedback control. The investigators designed a 3D interactive VR rehabilitation~     program that can guide and train the users through visual feedback. Each user performed a~     pre-test to examine determine condition, left-right balance and other parameters, which~     allows the system to be customized.~   "
114443|NCT02069483|"~     Smokers who are not actively engaged in quitting will participate in a study using~     self-generated text and audio text messages containing reasons to quit smoking.~   "
114459|NCT02069275|"~     The purpose of this study is to investigate the frequency of bleeding and haematomas in~     patients undergoing coronary angiography or percutaneous coronary intervention via femoral~     artery and mobilized immediately after the procedure, compared to those mobilized after two~     hours (following the standard regimen). At the same time the investigators will investigate~     whether it reduces the discomfort being mobilized immediately after the procedure.~   "
115799|NCT02051738|"~     The purpose of the study is to evaluate the effect of food on the bioavailability (how much~     medication is in your blood) of mebendazole from a single 500 mg oral dose of a~     fast-disintegrating chewable tablet formulation of mebendazole in healthy adult participants.~   "
114428|NCT02069678|"~     This will be a multi-center study in Hong Kong. This is a retrospective-prospective study in~     HBeAg-negative chronic hepatitis B patients. HBeAg-negative patients on entecavir followed up~     in the liver clinics will be identified from the existing database. All patients had HBV DNA~     testing every 6 months as a clinic routine. Serum HBsAg levels will be tested in the residual~     serum samples at the pre-treatment and last follow-up visits. Eligible patients will be~     discussed on the plan of stopping entecavir therapy. All patients will have written informed~     consent before recruited into this study. All patients will be followed up for 12 months~     after stopping entecavir treatment. As entecavir is most commonly used antiviral drug in Hong~     Kong and in the Western countries, the investigators aim to investigate and validate the use~     of serum HBsAg quantification to guide the timing of stopping entecavir in HBeAg-negative~     patients. The results of this study will provide scientific evidence on the use of this new~     serum marker to predict sustained remission after stopping entecavir. In the long-run, it can~     improve patient compliance, reduce the need of long-term antiviral and reduce the drug cost~     in the management of HBeAg-negative chronic hepatitis B.~      All patients will stop entecavir according to the Asian Pacific guideline with written~     informed consent and close subsequent monitoring. In the protocol, there is a safety net for~     re-treatment. There will not be any invasive procedure. There is no major ethical issue.~   "
114429|NCT02069665|"~     The purpose of this study is to evaluate the effectiveness of traditional Chinese medicine~     for treatment of pediatric pneumonia. It is a multicenter randomized controlled trial.~   "
114430|NCT02069652|"~     The data of Taiwan CDC showed the total HIV victims amounted up to 22,020 from 1984 to 2011.~     Under risk factor analysis, it indicated the increasing victims among MSM (men having sex~     with men, including homosexuals & bisexuals) cohorts, from 64% of them in 2009 to 72% in~     2011. For age stratification of patients, the youth (from 15 to 24 years old) comprised of~     18.5% (4078). Among them, 40% are students. MSM are still the main population (over 80%) from~     2009 to 2011. Therefore it is crucial to target the young MSM.~   "
114431|NCT02069639|"~     Relapsed and refractory Hodgkin's lymphoma (HL) patients may experience long-term survival~     after allogeneic transplant (alloSCT), but disease recurrence represents the main cause of~     treatment failure. PET (positron-emission tomography) -positive patients after alloSCT have a~     dismal outcome. Serum TARC (thymus and activation-regulated chemokine) is produced by~     Reed-Sternberg cells and may be a marker of disease. Our study was aimed at assessing whether~     TARC levels after alloSCT were correlated to disease status and whether TARC monitoring could~     increase the ability to predict relapse.~   "
114432|NCT02069626|"~     Bleeding from the staple line is a complication of linear stapling. After clamping, a short~     period after firing of the laparoscopic linear stapler is recommended. That is, the clinician~     should continue to press the tissue between the prongs of the device to achieve adequate~     hemostasis at the staple line. The significance of the waiting period for hemostasis at the~     staple line has not been empirically clarified in humans. In this study, the investigators~     compared the number of bleeding points use of the laparoscopic linear stapler. Consequently,~     the investigators assessed the effects of time after the firing of linear stapling in~     patients who underwent laparoscopic gastric bypass.~   "
114433|NCT02069613|"~     The objective of the study is to determine the relative roles for various testing modalities~     in the diagnosis and prognosis of mild traumatic brain injury.~   "
114434|NCT02069600|"~     Rationale: Almost all the information the investigators have about the effect of continuous~     positive airway pressure (CPAP) in patients with obstructive sleep apnea (OSA) comes from~     randomized clinical trials including only middle-aged patients. Little is know, however,~     about the effect of CPAP in elderly people with OSA. Objective: To assess the effect of CPAP~     treatment in elderly patients with severe OSA on clinical, quality-of-life and neurocognitive~     spheres. Methods and Measurements: Open-label, randomized, multicenter clinical trial of~     parallel groups with blinded end-point design conducted in 12 Spanish teaching hospitals on a~     consecutive clinical cohort of elderly (≥ 70 years) patients with confirmed severe OSA (IAH≥~     30) receiving CPAP or no therapy while maintaining their usual control for three months. CPAP~     titration was performed by an auto CPAP device. A good adherence was set as at least 4~     hours/day of CPAP use. Primary endpoint was the measurement of quality of life by the Quebec~     Sleep questionnaire, which includes diurnal and nocturnal symptoms, hypersomnolence, and~     social and emotional dimensions. Secondary endpoints include different sleep-related~     symptoms, presence of anxiety or depression, office blood pressure figures and some~     neurocognitive tests. Patients were invited to a clinical visit on three occasions to~     quantify the adherence to CPAP. Intention-to-treat analysis was performed.~   "
114435|NCT02069587|"~     Preterm premature rupture of membrane is associated with increased oxidative stress and~     inflammatory process, enhancing the activity or the availability of antioxidants may modulate~     the inflammatory response associated with PPROM, thereby reducing oxidative stress and the~     risk to the fetus. In this study the investigators sought to determine the effects of~     Pomegranate 1. On the patients (maternal and fetal) oxidative stress and inflammation~     associated with PPROM. 2. On the time interval from PPROM to delivery and on the patients~     (fetal )Ph and apger scores~   "
114436|NCT02069574|"~     The purpose of the present study is to identify the novel periodontal disease biomarkers~     using differentially expressed microRNA in the saliva. The severity of chronic periodontal~     diseases and the time of pre- and post-treatment are major classification criteria. The~     obtained data will secure the foundation for the development of a new non-invasive diagnostic~     methods for early diagnosis & prognosis prediction of periodontal disease.~   "
114437|NCT02069561|"~     The aim of this study is to test Eicosapentaenoic acid's effects on markers relevant to~     colorectal carcinogenesis, RNA and DNA profiles, and the possibility that Eicosapentaenoic~     Acid treatment might be associated with changes of the gut microbiota and metabolomic~     profiles in patients with long-standing ulcerative colitis.~   "
114438|NCT02069548|"~     This study addresses postures and range of motion in cervical dystonia (Spasmodic~     Torticollis). It uses 3D miniature and wireless motion captures sensors, and aims to increase~     the understanding of the biomechanics of the movement disorders of the cervical column in~     this pathology. In addition, the clinical state of cervical dystonia of the patients will be~     assessed, using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS). The~     investigators will compare the results between control and study groups.~   "
114444|NCT02069470|"~     Background Denmark has a lower survival of cancer compared to most European countries. Fast~     track pathways for organ specific cancers were established in the years 2008-2010. In 2011~     further a fast track pathway for non-specific serious symptoms. Cancer in general practice is~     a low prevalence condition. Each general practitioner (GP) will see 8-10 new cancer patients~     per year. The investigators know that cancer patients have an increased use of general~     practice prior to diagnosis and that 25% of them wait for more than 20 days in general~     practice for referral according to the GPs. The latest Danish Cancer Plan therefore includes~     a CME as a key strategy to lower the GP threshold to refer patients to cancer fast track~     pathways.~      The aim of this study was to investigate the effect of this CME in early cancer diagnosis.~     This is measured by changes in GP knowledge, attitude and risk assessment. GP referral~     behavior assessed by primary care interval and use of fast track referrals. GP´s cancer hit~     rate, cancer patients´ tumor stage at treatment and 1 year survival.~      Methods/Design The study is conducted as a stepped wedge controlled design based on a~     quasi-cluster randomization.~      In august 2012 an invitation to participate in the present study were sent to 859 general~     Practitioners (GPs) from the Central Denmark Region. GPs completed a form for each patient~     they referred to a fast-track diagnostic pathway for cancer within an 8-month period.~      Every other week, we received data from a regional database. We reminded the referring~     GP-practice about non included patients. The collected data will be linked to registries.~      The CME-intervention The CME-course was a 3-hour meeting after work. Guided by the available~     evidence from the literature following the investigators ensured a multifaceted interactive~     teaching method including case-based education. The content included by other topics positive~     predictive values, false reassurance from negative testing and other pit-false.~      Statistical analyses The outcomes will be analyzed in a generalized linear random-effects~     model with random effect of GPs. Based on data it will be assessed whether further modeling~     of inter correlation within practices and within clusters is required, and whether the~     intervention effects are assumed equal for all GPs, or in random interaction with them.~     Analyses will be performed both in the full GP-population (intention to intervening ) and~     in the 3 subgroups of GPs.~   "
114445|NCT02069457|"~     Several studies have confirmed that patients with cirrhosis possess an imbalance in~     procoagulant versus anticoagulant activity due to increased factor VIII and decreased protein~     C. Moreover, in the last two decades there has been an increased recognition that not only~     bleeding but also thrombosis complicates the clinical course of cirrhosis. The prevalence and~     pathogenesis of portal vein thrombosis (PVT) in patients with cirrhosis without~     hepatocellular carcinoma are not clearly defined. The Aim of this study is to assess the~     prevalence of portal vein thrombosis in patients with cirrhosis without hepatocellular~     carcinoma, and to prospectively assess the risk factors, outcome, and prognosis in these~     patients. The investigators plan to enroll two hundred patients with liver cirrhosis. The~     patients are going to follow up for one year and evaluate at baseline and every 6 months by~     liver function tests, coagulation test, upper abdomen ultrasound. All relevant clinical~     events will be evaluated at every follow up.~   "
114446|NCT02069444|"~     For endotracheal entubation in children mostly Miller and Macintosh blades have been used. On~     the other hand Truview EVO2 laringoscopes can maintain a better laryngeal view without having~     a direct sight of the airway and without having to align oral, pharyngeal, and tracheal axes.~     The aim of this study is to compare the Truview EVO2 laryngoscope and Macintosh laryngoscope~     in terms of intubation difficulty score, time to intubation and intubation quality score.~   "
114447|NCT02069431|"~     The life expectancy of older Americans continues to increase, with persons aged > 65 years~     representing the fastest growing segment of the US population (Manton et al., 1995). While~     prolongation of life remains an important public health goal, a goal of even greater~     significance is that extended life should involve preservation of the capacity to live~     independently and to function well physically, cognitively, and socioemotionally (Katz et~     al., 1983). Therefore, identification of proven interventions to maintaining functioning~     across these domains and prevent disability is a major public health challenge (Branch et~     al., 1991). Greater physical and cognitive independence in older adults has been shown to~     crucially influence social integration in old age (Cornwell & Waite, 2009), resulting in~     significant increase in quality of life and reduction of risk for morbidity and mortality,~     social stress, anxiety, and depressive symptoms (Bassuk et al., 1999; Seeman, 1996). A~     promising candidate to promote functional levels across physical, cognitive, and~     socioemotional domains is the neuropeptide oxytocin (OT) (Barraza et al., 2013; Bartz et al.,~     2011; Feifel et al., 2012; Meyer-Lindenberg et al., 2011; Szeto et al., 2012). Combining~     neuroendocrine with behavioral approaches (e.g., performance-based measures of physical and~     cognitive function), the proposed multidisciplinary research therefore sets out to clarify~     the extent to which intranasal administration of OT over a period of 4 weeks can reduce~     inflammation and improve physical and cognitive function in older men. Constituting a~     complementary piece to the IRB approved currently ongoing Faces Study (IRB # 39-2013), this~     project will also allow examination of interactions between OT's effect on physical health,~     cognition, and socioemotional function.~   "
114448|NCT02069418|"~     In France, lung cancer is the leading cause of death induced by cancer. Therapeutic advances~     have been made in therapy of unresectable non-small cell lung cancer (NSCLC) with tyrosine~     kinase receptor inhibitors blocking the Epidermal Growth Factor Receptor (EGFR), as~     erlotinib.~      This drug usually does not induce rapid shrinking of NSCLC tumour explaining why RECIST~     criteria are less reliable with erlotinib than cytotoxic drugs after 8 weeks of treatment.~      Among patients with unresectable NSCLC, 3'-deoxy-3'-18F-fluoro-L-thymidine (18F-FLT) and~     18F-2-18F-fluoro-2-deoxy-D-glucose (18F- FDG) Positron Emission Tomography (PET) has~     identified early responding patients and with better progression-free survival in erlotinib~     first line and in the second or third line.~      To date, none medico-economic study has been conducted to determine if this strategy will be~     cost-effective.~      The purpose of this study is to confirm that an early metabolic imaging with 18 F-FLT and~     18FFDG PET could have theranostic issue by identifying at the fourteenth day of erlotinib~     (second line or more) the subjects that do not respond to erlotinib, i.e. 6 weeks prior to~     the morphological evaluation based on the new RECIST 1.1, that is typically done at week 8 of~     erlotinib treatment.~      A health economics ancillary study will be achieved. Indeed, recent therapeutic improvements,~     in particular targeted therapies in NSCLC, have improved quality of life and life expectancy,~     but have also induce an important increase of the health costs. According to studies, the~     mean cost of the treatments of NSCLC has been increased by a factor 3 during the 10 last~     years. More efficient strategies that would permit to stop early with objective endpoints,~     expensive therapies is a main achievement in thoracic oncology.~      The potential clinical impacts of this work are 1) to stop early erlotinib in non-responders~     and replace another treatment before a deterioration in their physical status, 2) reduce the~     risk of side effects and costs of unnecessary treatment and 3) to propose a customization~     treatment after the first line therapy.~   "
114449|NCT02069405|"~     To acquire low radiation dose and good quality cardiac CT images requires scanning at low~     heart rates which is usually done with beta-blockers. However, in some patients beta-blockers~     have little effect. This is thought to be due to a different mechanism of action which~     continues to maintain the heart rate despite administration of beta-blockers. This study aims~     to look at the effect of music or relaxation tracks to reduce patient heart rate as anxiety~     is thought to play a role in maintaining high heart rates. This study will randomise patients~     into a normal standard of care group compared to a normal standard of care group with music/~     relaxation track and compare heart rate, radiation dose, image quality, amount of~     beta-blocker used and patient experience via a State-Trait Anxiety Inventory (STAI)~     questionnaire.~   "
114450|NCT02069392|"~     Schizophrenia is marked by problems in attention, memory and problem solving. These deficits~     predict long-term functional outcome such as the ability to live independently and maintain~     employment, but they are not ameliorated by currently available medications. Cognitive~     training improves these functions to some degree, but this approach is time- and~     resource-intensive. The current project aims at enhancing and accelerating the benefits that~     people with schizophrenia derive from cognitive training by administering nicotine during~     some of the training sessions. This would provide the proof of principle for a type of~     treatment intervention to improve cognitive symptoms of schizophrenia.~      The current project aims at determining whether the intermittent presence of nicotine during~     cognitive training exercises in people with schizophrenia will shorten the training period~     necessary to induce significant and clinically relevant improvement and enhance the~     improvement seen after a training period of specified length.~      Hypothesis 1a: Nicotine administration during training will increase the size of all measured~     effects of the training intervention, and will accelerate the time course of performance~     enhancement on the MCCB and training exercise progression parameters.~      Hypothesis 1b: The larger training effects in the Nicotine Group will persist beyond the end~     of the intervention.~      Hypothesis 2a: Within-session progress on the training exercises will be larger in the~     presence of nicotine than in the presence of placebo.~      Hypothesis 2b: These acute nicotine-induced performance elevations will persist beyond the~     presence of nicotine through subsequent non-drug training sessions, giving evidence of an~     acute facilitation of learning processes.~   "
114451|NCT02069379|"~     Insulin resistance, a primary component of the metabolic syndrome, is an escalating~     phenomenon in the United States, and confers an increased risk of depression and mood~     disorder, particularly in women. The relationship between metabolic and mood disorders may be~     mediated by endogenous opioid activity in limbic brain regions. We propose to examine~     affective state and μ- opioid system function in insulin resistant women, and change in~     response to insulin sensitizing treatment, through the following specific aims and~     hypotheses:~      Establish relationship between insulin resistance, affective state, and μ-opioid receptor~     function.~        1. Insulin resistant women will have greater μ-opioid receptor availability at baseline,~          and a larger response to stress challenge than non-insulin resistant women~        2. Insulin resistant women will have greater negative affective state at baseline, and a~          greater emotional response to stress challenge than non-insulin resistant women.~        3. Mediational analyses will reveal that the relationship between insulin resistance and~          negative affect is mediated by μ-opioid receptor function and neural activation in the~          amygdala and nucleus accumbens affect-regulating regions.~      Examine effects of insulin regulation on μ-opioid receptor function and affective state.~        1. Improved insulin sensitivity will be accompanied by decreased μ-opioid receptor~          availability at baseline and a reduced response to stress challenge. Degree of change in~          baseline receptor availability and response to stress challenge after treatment will~          correlate with degree of insulin regulation.~        2. Improved insulin sensitivity will be associated with improved affective state at~          baseline, and with a reduced emotional response to stress challenge. Degree of change in~          affective state and emotional response to stress challenge after treatment will~          correlate with degree of insulin regulation.~        3. Mediational analyses will reveal that the change in affective state after insulin~          regulation is mediated by change in μ-opioid receptor function and neural activation in~          the amygdala and nucleus accumbens.~      The expected results would suggest a role for the endogenous μ-opioid system in mediating the~     relationship between metabolic function and emotional processes.~   "
114452|NCT02069366|"~     The goal of this study is to look at how a type of drug called cannabinoids are related to~     the processing of fear signals, the experience of emotions and fear, and the pattern of~     activity in the brain that is involved in these processes and how this relates to the~     development of post-traumatic stress disorder (PTSD). PTSD is an anxiety disorder that occurs~     after experiencing a traumatic event(s) and is characterized by unwanted memories of the~     trauma(s) through flashbacks or nightmares, avoidance of situations that remind the person of~     the event, difficulty experiencing emotions, loss of interest in activities the person used~     to enjoy, and increased arousal, such as difficulty falling asleep or staying asleep, anger~     and hypervigilance. The information gained from this study could lead to the development of~     new treatments for persons who suffer from anxiety or fear-based disorders.~   "
114453|NCT02069353|"~     Cardiac arrest is the most common cause of death in the United States and as many as 590,000~     Americans suffering a cardiac arrest each year. Despite advances in care, as many as 50 to~     89% of patients who are resuscitated after a cardiac arrest die in the hospital. Brain injury~     is the most common cause of death and disability after cardiac arrest. The investigators use~     advanced brain monitoring in patients who are at high risk of death after cardiac arrest,~     with the goal of preventing ongoing brain injury. The most common problem the investigators~     have observed is low oxygen levels in the brain, which is often very difficult to treat.~      In this study, the investigators plan to use two additional brain monitors in the care of~     these high risk patients: a monitor for seizures and a monitor of the amount of blood flow in~     the brain. The investigators will use these to detect and treat potential causes of low brain~     oxygen levels. The main hypotheses are that electrical events in the brain such as seizures~     and spreading depolarizations will occur during times of low brain tissue oxygen level, and~     that treating these events and low blood flow will reduce the rate of low brain oxygen~     levels.~   "
114454|NCT02069340|"~     This randomized clinical trial studies genetics in predicting risk of bisphosphonate-related~     osteonecrosis of the jaw in patients with cancer receiving zoledronic acid. Zoledronic acid~     is an anti-resorptive drug used as part of cancer treatment. A serious side effect of these~     drugs is death of the jawbone, commonly called bisphosphonate-related osteonecrosis of the~     jaw (BRONJ). Genetic research may help doctors understand risk factors for BRONJ or who is~     more likely to get BRONJ and why.~   "
114455|NCT02069327|"~     This is an observational study designed to investigate the role of fat emboli in patients who~     are undergoing a tibial or femoral fracture procedure in the operating room. The purpose of~     this study is to obtain samples of bone marrow and blood during tibial or femoral fracture~     procedures to understand the inflammatory response.~   "
114456|NCT02069314|"~     This research study was conducted to investigate the effects of a high protein diet on the~     efficiency of energy use at rest and at low-levels of physical activity. The hypothesis was~     that a high intake of dietary protein would result in a less efficient use of energy in~     skeletal muscle in older adults.~   "
114457|NCT02069301|"~     The study evaluates LIFE-DM, an integrated microfinance and collaborative care intervention~     by comparing it to enhanced treatment as usual (national guideline antidepressant care and~     referral to microfinance resources) in Vietnam. Intervention effects at baseline, 6 month,~     and 12 month follow-up on patient outcomes, including depression, anxiety, quality of life,~     functioning, self-efficacy, satisfaction, and income will be compared across the two~     conditions.~   "
114458|NCT02069288|"~     Septic shock (associated with relative adrenal insufficiency) is characterized by decreased~     arterial responsiveness to catecholamines. The association of hydrocortisone and~     fludrocortisone has demonstrated an improvement in survival in septic shock patients. If~     hydrocortisone has shown to increase vascular responsiveness, the role of fludrocortisone~     remains to be elucidated. The purpose of our study is to investigate the effect of a~     physiological dose of fludrocortisone alone on norepinephrine-mean arterial pressure~     dose-response relationship, gastric mucosal perfusion and arterial stiffness in patients with~     septic shock.~   "
114460|NCT02069262|"~     There were many approaches for patients with obscure gastrointestinal bleeding (OGIB).~     Capsule endoscopy (CE), double-balloon endoscopy, deep small-bowel spiral enteroscopy,~     laparoscopy, computed tomography and angiography have been recommended as investigation.~     However, of these techniques, the evaluation and management of patients with OGIB remains a~     formidable challenge. We compared the diagnostic yield and long-term outcomes of patients~     with OGIB randomized to angiogram combination laparoscopy or angiogram alone.~   "
114461|NCT02069249|"~     The proposed study has the following aims: (a) to assess the concomitant and longitudinal~     links between sleep and cognitive, behavioral and emotional functioning in kindergarten~     children; (b) to assess the immediate and the long-term effects of an intervention to promote~     healthy sleep habits (HSI) on the child's evolving sleep patterns, as well as on related~     cognitive, behavioral and health domains; (c) to assess the immediate and the long-term~     effects of an intervention deigned to promote healthy nutrition (HNI) on the eating habits of~     children, their weight and BMI measures (the comparison/control group) and (d) to assess the~     links between eating habits and sleep in kindergarten children.~      The main hypotheses of the proposed study are: (a) Shorter and more disrupted sleep would be~     concomitantly and longitudinally associated with compromised cognitive, emotional and~     behavioral functioning in kindergarten children; (b) In comparison to the HNI group, children~     in the HSI group will extend their total sleep time, improve their sleep quality and their~     sleep schedule will be more stable following the intervention; (c) improvement in sleep~     habits will be associated with improvement in cognitive, emotional and behavioral~     functioning; (d) in comparison to the HIS group, children in the HNI group will improve their~     eating habits, engage in more physical activities and better manage to achieve and maintain~     an age-appropriate body weight.~   "
114462|NCT02069236|"~     In this study we propose to determine the correlation in glucose-6phosphate dehydrogenase~     enzyme activity in capillary blood obtained from a finger stick versus a venous blood~     specimen. As secondary endpoints we will seek to correlate phenotype as determined by~     quantitative and qualitative G6PD test, genotype as determined by PCR and DNA sequencing with~     flow cytometry. The secondary endpoints are critical for the design of G6PD diagnostic test~     evaluation studies.~   "
114463|NCT02069223|"~     Bariatric surgery procedures promote weight loss by limiting the amount of food consumed~     through reduction of the size of the stomach and by decreasing absorption of nutrients~     through reorganizing or bypassing portions of the small intestine. Among the procedures used~     to induce weight loss, sleeve gastrectomy (SG) was initially developed in the early 90's as~     the restrictive component of a biliopancreatic diversion with duodenal switch (BPD-DS). It~     was then offered by laparoscopy as a staged-approach in order to reduce peri-operative~     complications in high-risk patients. The second step of the surgery (i.e. the duodenal~     switch) was planned when sufficient weight loss had been obtained. However, it was observed~     that some patients experienced appreciable weight loss with the SG alone, and did not require~     a second-stage surgery, thus avoiding the side-effects of a malabsorptive surgery. This led~     to the surge in popularity of SG as a stand-alone operation, because of its relative~     technical simplicity, feasibility, and good outcomes. Multiple mechanisms have been~     postulated to induce metabolic recovery and weight loss following surgery. The independent~     effects of each component of the BPD-DS with SG have never been investigated in humans within~     a well-controlled study design. The general objective of the present project is to assess the~     impact of each component of the BPD-DS and SG, either combined of separated, on physiological~     variables potentially responsible for metabolic recovery. Patients will be randomized to~     undergo one of three surgical sequences: 1) SG followed by BPD-DS one year later; 2) BPD-DS~     followed by SG one year later; or 3) SG and BPD-DS within a single operation. A series of~     tests will be performed at baseline, at 1 year, and 2 years after the initial surgery. We~     propose two Specific Aims to asses 1) the impact of each surgical component on the hormonal~     determinants of metabolic recovery; and 2) the impact of weight loss responses on~     subcutaneous and visceral adipose tissue function improvements. This project will help better~     understand the mechanisms underlying metabolic recovery following weight loss surgery.~   "
114464|NCT02069210|"~     The purpose of this study is to investigate the effect of transfusion of allogeneic~     (homologous) red cells on the immunologic parameters such as T-cells as well as natural~     killer cell count/function, various interleukins, TNF alpha and other immunologic relevant~     parameters on postoperative day 1,3 and 5-7 in patients undergoing spine surgery.~   "
114465|NCT02069197|"~     The purpose of the study is to evaluate the efficacy and safety of ketogenic diet (KD)~     treatment of (i) obesity, (ii) type 2 diabetes mellitus and (iii) obstructive sleep apnea~     (OSA) in patients with obesity and Type 2 DM and in patients with obesity and/or OSA. This~     will be a randomized, open-label three arm controlled study comparing weight loss in obese~     participants with type 2 diabetes and/or obstructive sleep apnea treated for 9 months with~     3:1 [fat]:[protein+carbohydrate] ratio, 1600 kcal/day diet (Group A) with weight loss in~     participants treated with orlistat 120 mg TID and lifestyle intervention consisting of~     dietary advice, recommended caloric goal of 1600 kcal/day (Group B), and in participants~     treated with only lifestyle intervention consisting of dietary advice, recommended caloric~     goal of 1600 kcal/day (Group C).~   "
114466|NCT02069184|"~     Post-operative pain management after C-section is an important topic as the number of~     elective c-sections increases each year. Pain is managed either by giving opioids or by using~     non-opioids. The purpose of this study is to evaluate the effectiveness of IV Acetaminophen~     in pain relief and its impact in the usage of post-operative opioid requirements and opioid~     associated complications. The hypothesis is that four doses of IV Acetaminophen in~     conjunction with intrathecal or epidural morphine given to the patients after c-section will~     reduce post-operative opioid requirements and opioid associated complications.~   "
114467|NCT02069171|"~     The purpose of this study is to identify the incidence,feature,clinical significance for leg~     lymphedema after gynecologic cancer treatment.~   "
114468|NCT02069158|"~     This is a phase Ib single arm, open-label, multiple dose, dose escalating, safety,~     pharmacokinetic and pharmacodynamic study of the combination of PF-05212384 with paclitaxel~     and carboplatin. The study will be conducted in adult patients with advanced breast, NSCLC,~     ovarian or endometrial, small cell lung cancer (SCLC) and Head and Neck (HNSCC) cancer for~     whom there is an indication to the use of paclitaxel and carboplatin.~      Successive cohorts of patients will receive escalating doses of PF-05212384 in combination~     with paclitaxel and carboplatin, starting at a dose level determined to be the 60% of single~     agent MTD.~      The study will consist of two parts: the dose finding part (Part 1) and the expansion part~     (Part 2).~      During Part 1 patients with breast, NSCLC, ovary and endometrial, small cell lung cancer~     (SCLC) and Head and Neck (HNSCC) cancer will be enrolled.~      During Part 2, only patients with ovarian cancer will be enrolled. In Part 1, a 3+3 design is~     employed. Once the MTD of the combination is defined in Part 1, Part 2 is performed for a~     better definition of the safety profile, of the potential antitumor activity and of the~     pharmacodynamic effects of the combination; it will be conducted in at least 12 patients with~     ovarian cancer.~      Approximately 40 patients are expected to be enrolled in the study overall.~   "
114469|NCT02069145|"~     This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and~     PK of OMP-54F28 when combined with sorafenib. OMP-54F28 will be administered IV on Day 1 of~     each 21-day cycle. The planned dose levels of OMP-54F28 are 5 and 10 mg/kg. Depending on~     safety in this study, additional lower or intermediate dose levels may be evaluated.~   "
114470|NCT02069132|"~     The purpose of this study is to validate the International Warfarin Pharmacogenetics~     Consortium (IWPC) algorithm in a prospective cohort of elderly people (65 years or older)~     with heart valves and/or nonvalvular atrial fibrillation (AF) and at least one comorbid~     condition, and to assess the algorithm's prognostic relevance.~   "
114471|NCT02069119|"~     To investigate the safety, pharmacokinetics, and efficacy following 30-minute continuous~     intravenous administration of OPC-108459 at 0.4, 0.8, 1.6, or 2.4 mg/kg or placebo to~     patients with paroxysmal or persistent atrial fibrillation~   "
114472|NCT02069106|"~     Pro-Omega LDL reduces low-density lipoprotein cholesterol and triglycerides in subjects with~     mixed hyperlipoproteinemia.~   "
114473|NCT02069093|"~     Open-label, Phase II study of Stomatitis prevention with a steroid-based mouthwash in~     Post-menopausal women with ER+, HER2- Metastatic or Locally Advanced Breast Cancer~   "
114474|NCT02069080|"~     In mouse models and in patients, expression of the chemokine receptor CXCR4 on various~     cancers has been correlated with aggressive biological behavior, including increased rates~     and certain sites of metastasis, and decreased survival. Plerixafor (Mozobil ; Genzyme;~     Cambridge, MA) has been identified as a specific inhibitor of CXCR4, and it is currently~     approved by the Food and Drug Administration as a stem-cell mobilizing agent in combination~     with granulocyte colony-stimulating factor in the treatment of non-Hodgkin's lymphoma and~     multiple myeloma. Our group has recently shown that plerixafor can be labeled with the~     positron-emitting radionuclide copper-64((64)Cu) to form (64)Cu-plerixafor, which can be used~     to visualize CXCR4-positive tumor xenografts in mice using small-animal positron emission~     tomography (PET). Determining CXCR4 expression in tumors using (64)Cu-plerixafor and~     PET/computerized tomography (CT) scanning could be useful in predicting tumor behavior and~     responses to current and experimental therapies, including therapies targeting CXCR4, which~     could lead to more effective personalized cancer treatments.~      This study s primary objective is to evaluate (64)Cu-plerixafor as an imaging agent for~     quantifying CXCR4 expression in subjects (greater than or equal to 18 years of age) with~     cancer; at least 1 detectable solid tumor of greater than or equal to 2 cm in diameter found~     outside of the lymph nodes, bone marrow, liver, gallbladder, kidney, bladder, and brain; and~     preexisting biopsies of the tumors obtained since the first detection of the current~     occurrence/recurrence of disease. The secondary objectives are to correlate (64)Cu-plerixafor~     standardized uptake value in the target lesion with the level of CXCR4 expression detected~     via immunohistochemistry and to calculate human dosimetry for (64)Cu-plerixafor.~      Preexisting tumor biopsies from less than or equal to 75 subjects recruited from the National~     Cancer Institute and the Georgetown University Hospital will be evaluated for CXCR4~     expression via immunohistochemistry. Subjects who meet the eligibility criteria will continue~     onto the study. Five subjects with CXCR4-positive tumor biopsies will be administered an~     initial intravenous infusion of (64)Cu-plerixafor (8 +/-0.8 mCi ; 0.48+/- 0.048 rem; not to~     exceed 5 microg of (64)Cu -plerixafor) over 2 minutes. They will then undergo an initial~     low-dose transmission CT scan followed by 3 consecutive torso PET scans as soon as practical~     after the infusion, and 2 additional PET/CT scans at 4 hours +/- 1 hour and 24 hours +/- 2~     hours post-infusion. Human dosimetry will be calculated based on these results, and a maximum~     dose will be used, not to exceed the calculated limit of a total effective dose of 5 rem, or~     the radiation exposure limit for each organ. The remaining subjects with CXCR4-positive~     (n=15) and CXCR4-negative (n=5) tumor biopsies will be administered 64Cu-plerixafor at the~     same, or a newly calculated dose, and will undergo 1 PET/CT scan between 1 and 4 hours~     post-infusion, depending on the dosimetry results. All subjects will undergo one~     comprehensive final study visit between study days 19 and 23 (11-17 days after injection with~     (64)Cu -plerixafor). Additionally, blood will be collected 2 more times between study days~     13-16 and study days 26-30 to measure blood cell counts.~   "
114475|NCT02069067|"~     The purpose of this study is to describe how often advanced cancer patients experience~     breakthrough pain (BTcP), and to describe how this pain is treated, and how effective these~     treatments are.~   "
114476|NCT02069054|"~     Asthma and chronic obstructive pulmonary disease (COPD) are inflammatory airway diseases.~     Although the clinical features of asthma and COPD may be similar, the pathogenesis of these~     diseases differs in many aspects.~      The aim of this study is:~        -  to evaluate airway inflammation in asthma and COPD,~        -  to evaluate airway remodeling in asthma and COPD as compared to healthy subjects,~        -  to assess the relationship between markers of airway inflammation and airway remodeling~          in asthma and COPD patients.~      Material and methods:~        -  mild to moderate asthma patients diagnosed in accordance with Global Initiative for~          Asthma (GINA) guidelines,~        -  mild to moderate COPD patients diagnosed in accordance with Global initiative for~          chronic Obstructive Lung Disease (GOLD) guidelines,~        -  healthy subjects as controls.~      Airway inflammation is assessed in induced sputum (IS), exhaled breath condensate (EBC),~     bronchoalveolar lavage fluid (BALF) and specimens from endobronchial forceps biopsy. Airway~     wall thickness is evaluated in high resolution computed tomography (HRCT), endobronchial~     ultrasound (EBUS) and basement membrane thickness (BMT) in biopsy specimens.~      We plan to compare airway inflammation and features of airway remodeling in asthma and COPD~     patients.~   "
114477|NCT02069041|"~     The main purpose of this study is to determine if the advised dose of ramucirumab is safe to~     be taken with chemotherapy treatment in participants with advanced liver tumors.~   "
114478|NCT02069028|"~     This is a systematic review and Meta-Analysis of interventions for implementation of~     Surviving Sepsis Campaign guidelines and their impact on compliance and mortality reduction~   "
114479|NCT02069015|"~     The primary aim of the study is to determine if enhanced discharge from the emergency~     department will improve blood pressure control and self-care management. Enhanced discharge~     will include a hypertension intervention delivered by a touch-screen kiosk over a three month~     period.~   "
114480|NCT02069002|"~     The aim of the current study is to compare the effictiveness of three different psychosocial~     therapies for treating functional disorders caused by indoor air problems.~   "
114481|NCT02068989|"~     We hypothesize that stress hyperglycemia is an indicator that a patient will develop type 2~     diabetes mellitus in the future. Subjects who are not diabetic are enrolled and blood glucose~     readings reviewed during their intensive care unit stay. All subjects are consented and have~     a HbA1C level drawn to determine if they have diabetes mellitus or not. They are then~     followed up in 1 year and the HbA1C repeated to determine if they have developed diabetes~     mellitus over the course.~   "
114482|NCT02068976|"~     This is an observational epidemiologic multicentric study of follow-up a cohort for described~     the situation of patients with primary ovarian insufficiency in public population with~     respect to the age of apparition the primary ovarian insufficiency .~   "
114483|NCT02068963|"~     This non-interventional clinical study will be conducted to prospectively collect serial~     plasma and serum samples from treatment naïve subjects with chronic HCV infection who are~     initiating sofosbuvir-based therapy. These samples will be used to estimate clinical utility~     endpoints for the Aptima HCV Quant Dx assay which is used an aid in the management of~     HCV-infected patients undergoing HCV antiviral therapy.~   "
114484|NCT02068950|"~     The purpose of this study is to evaluate the feasibility of a 12-week progressive resistance~     training (PRT) during concurrent chemoradiotherapy in head and neck cancer patients compared~     to usual care.~   "
114485|NCT02068937|"~     One of the challenges in treating patients with heart failure (HF) is achieving clinical~     stability and reducing the hospital readmission rate. A diuretic dose adjustment algorithm~     developed in the United States (Diuretic Treatment Algorithm, DTA) and later validated for~     use in Brazil (as the Algoritmo de Ajuste de Diurético, AAD) has proved feasible and readily~     applicable, but its effect on clinical outcomes has yet to be assessed. This report aims to~     describe a randomized clinical trial protocol designed to assess the effectiveness of the AAD~     and of nonpharmacologic management in improving clinical stability and reducing the~     readmission rate at 90 days in patients with HF.~   "
114496|NCT02068794|"~     This phase I/II trial studies the side effects and best dose of oncolytic measles virus~     encoding thyroidal sodium iodide symporter (MV-NIS) infected mesenchymal stem cells and to~     see how well it works in treating patients with ovarian cancer that has come back.~     Mesenchymal stem cells may be able to carry tumor-killing substances directly to ovarian~     cancer cells.~   "
114507|NCT02068651|"~     Advance care planning has been recommended as an integral part of care for patients with~     life-limiting disease, but relevant development in Hong Kong is still in its infancy. This~     proposed study attempts to address this service gap by promoting advance care planning to~     patients with advanced disease. It is hypothesized that the proportion of patients whose~     end-of-life care preferences were known in the experimental group will be significantly~     higher than that in the control group.~   "
114486|NCT02068924|"~     Improvement in the treatment of infertility by Assisted Reproductive Techniques (ART) allows~     single embryo transfer to be applied without compromising pregnancy rates after the first in~     vitro fertilization (IVF) or Intra Cytoplasmic Sperm Injection (ICSI) attempt in women less~     than 36 years old with good embryo quality. The policy of transferring more than one embryo~     after IVF or ICSI has been the main reason for the numerous twin or triple pregnancies~     reported in Europe and United States over the past 15 years. These multiple pregnancies are~     the main disadvantage of ART because of their negative impact on obstetrical, neonatal and~     economic outcome. In the past, embryos were replaced in the uterus on either Day-2 or 3 of~     development at the cleavage stage. With the development of physiologically-based sequential~     culture media, it has also been suggested that extending embryo culture to Day-5 in order to~     transfer the embryo at the blastocyst stage would enhance the likelihood of pregnancy.~     Nevertheless, it has been observed higher pregnancy rate after the transfer of fresh~     blastocyst but not after the transfer of thawed blastocyst frozen by slow freezing procedure.~      However a recent embryo freezing technique (vitrification) seems to show significant higher~     pregnancy rates when blastocyst are frozen by this method. To our knowledge, no publications~     have reported the outcome of single embryo transfer at blastocyst stage by a prospective~     randomized and comparative study including the results of fresh and frozen/thawed blastocyst~     by these two methods (slow freezing vs. vitrification) in case of single embryo transfer .~      Therefore, the aim of our study is to analyze whether extended culture of Day-2 top embryos~     to blastocyst-stage may improve the cumulative delivery rate in an in vitro fertilization~     program with Single Embryo Transfer policy in a prospective and randomized study integrating~     the transfer of fresh and frozen/thawed embryos using a slow freezing versus vitrification~     procedure.~   "
114487|NCT02068911|"~     The purpose of this study is to compare the measure of the CO2 obtained on the end-tidal~     expiratory gas (ETCO2) with the value of CO2 obtained by transcutaneous measure (PTCO2), in~     home-ventilated neuromuscular patients.~   "
114488|NCT02068898|"~     The study will assess bioavailability of XS003 given as a single oral dose compared to~     Tasigna® given as a single oral dose in healthy male subjects.~   "
114489|NCT02068885|"~     This study will evaluate the effects of dietary composition on energy expenditure and chronic~     disease risk factors, while also exploring physiological mechanisms underlying these effects.~   "
114490|NCT02068872|"~     The rapid rise in obesity (body mass index (BMI) ≥ 30 kg/m2) in the US over the past decade~     is responsible for more disease and death than any other single factor. Severe obesity is~     associated with numerous co-morbidities contributing to increased mortality risk, including~     end stage liver disease. Liver transplantation is a life-saving procedure for patients with~     end stage liver disease and obesity is becoming increasingly prevalent in this population. In~     one study, 54% of patients undergoing orthotopic liver transplant (OLT) were either~     overweight or obese [body mass index (BMI) >25 kg/m2], and 7% were severely or morbidly obese~     (BMI > 35 kg/m2). In addition, weight gain after solid organ transplantation is common~     because of steroid-containing immunosuppression and physical inactivity from decreased~     exercise tolerance.~      Obesity has been shown to increase the surgical morbidity, including wound infections, wound~     dehiscence, and hernias after transplantation. More significantly, excess pretransplant body~     weight hinders the rate of improvement in health-related quality of life after liver~     transplantation[7].~      One possible approach for treating obesity after a liver transplant is to use bariatric~     surgery. Currently, bariatric surgery is established as the most effective means for both~     weight loss and resolution of metabolic disease in the morbidly obese. Recent publications~     emphasize the usefulness of bariatric surgery in the reduction of long-term cardiometabolic~     risk, cardiovascular disease incidence and mortality, and the management of uncontrolled type~     2 diabetes (T2DM). In addition, it decreases mortality and improves both social functioning~     and quality of life.~      Bariatric surgery may improve eligibility for transplant in patients previously excluded due~     to excessive weight. Bariatric procedures, such as sleeve gastrectomy, allow for significant~     weight loss over time that greatly reduces or eliminates obesity related illnesses such as~     diabetes, high blood pressure and liver disease.~      According to the National Institutes of Health, bariatric surgery is reserved for patients~     with a BMI of > 40 or > 35 kg/m2 in the presence of major co-morbidities (e.g. type 2~     diabetes, hypertension, sleep apnea, heart disease, etc).~      A significant number of liver transplant candidates have obesity-related illnesses, thus~     putting them at risk for cardiovascular and metabolic complications post-transplant. In~     addition, patients awaiting OLT are typically no longer medically stable to undergo intensive~     diet and exercise regimens as treatment for their diseases. Finally, decreased activity and~     medications used to prevent liver graft rejection all contribute to increased weight gain~     following transplant. In fact, in a series of 320 non-obese liver transplant recipients,~     21.6% of patients became obese within two years of transplant. These comorbidities also~     contribute to poorer post-transplant outcomes and development of what is known as the~     post-transplant metabolic syndrome. Morbidly obese patients (BMI > 40 kg/m2) may also have~     higher frequencies of morbidities such as prolonged hospitalization and readmission as well~     as infectious, wound, and cardiovascular complications after transplantation. Finally,~     intra-abdominal adiposity creates a technically more challenging operative dissection, but no~     data exist on whether it increases perioperative morbidity or mortality in liver transplant~     patients.~      Sleeve gastrectomy is the most attractive restrictive procedure in a liver transplant~     population for several key reasons. One, sleeve gastrectomy does not require the implantation~     of a foreign body, such as placement of an adjustable gastric band, which in an~     immunocompromised post-transplant patient raises concern for severe infectious complications.~     Secondly, as stated previously, sleeve gastrectomy is a purely restrictive procedure, and~     therefore is least likely to cause significant macronutrient and micronutrient deficiencies.~     Finally, when compared to other restrictive procedures, such as adjustable gastric band~     placement, it has a lower likelihood of treatment failure (i.e. <50% excess weight loss). In~     fact, recent reports describe not only high failure rates with adjustable gastric band~     placement, but also high reintervention rates for both band-related complications (e.g. band~     erosion, leakage, slippage, port infection and esophageal dilatation) and failure to lose~     weight such that as few as 54% of patients may have their band in place after 10 years.~   "
114491|NCT02068859|"~     Non-steroidal anti-inflammatory medication (NSAID) therapy is a mainstay treatment for joint~     pain and painful musculoskeletal disorders. Though this form of systemic therapy is highly~     effective, it causes substantial side effects including gastritis and gastric ulcer disease,~     renal impairment, hypertension, and thrombotic events. These types of oral medications are~     utilized by millions of Americans on a fairly regular basis in both over-the-counter~     preparations and prescription compounds. In recent years, topical preparations of NSAIDs have~     been used for localized pain as an alternate to oral administration with reported good~     analgesic efficacy. For example, they are often used for knee pain. There is little systemic~     absorption of NSAIDs with topical administration, and consequently less likelihood of~     systemic side effects.~      Though much less studied than oral NSAIDs, topical NSAID preparations are currently~     prescribed for a variety of arthritic and musculoskeletal types of pain. The best-studied~     commercially available products are diclofenac 1% compounds. Higher concentrations presumably~     provide higher tissue concentration leading to better and longer pain relief, along with a~     more prominent anti-inflammatory effect.~      The investigators will therefore compare the efficacy of available topical diclofenac 1% gel~     to that of diclofenac 8% cream. Specifically, the investigators propose to test the~     hypothesis that efficacy of topical diclofenac 8% exceeds that of diclofenac 1%, without any~     increase in systemic toxicity.~      One hundred six patients presenting to the Cleveland Clinic Pain Management Department for~     the treatment of knee pain will be randomly assigned to topical diclofenac cream 8% or~     diclofenac gel 1%, with the designated medication applied the symptomatic area of the knee~     over 6 weeks. Investigators will be blinded to treatment, and will evaluate pain relief and~     functional/disability status.~   "
114492|NCT02068846|"~     The purpose of this study is to analyze BK viral infection in salivary gland diseases;~     specifically, to determine a definitive relationship between BK Virus and HIV associated~     salivary gland disease (HIVSGD). Participants are adults HIV+SGD+ who will be randomized 1:1~     to receive BK Virus antiviral (ciprofloxacin) or placebo for 28 days. Salivary~     function/protein secretion will be correlated with BK polyomavirus titers. We expect that~     patients with HIV+SGD+ will have elevated oral BK polyomavirus viral loads and will benefit~     from Ciprofloxacin.~   "
114493|NCT02068833|"~     Favorable effects of bariatric surgery have been demonstrated in particular regarding~     increased insulin sensitivity, decreased blood pressure, improved blood lipids and decreased~     cardiovascular risk. After surgery, weight loss also leads to improvement of the chronic~     inflammatory state related to obesity, a strong predictor of the metabolic status. Although~     obese patients are often affected with type 2 diabetes and hypertension, both related to~     renal impairment, the existence of a distinct mechanism by which obesity would cause chronic~     renal insufficiency has been suggested. The mechanisms underlying obesity-related nephropathy~     have been proposed to involve hyperfiltration, expansion of mesangial cells, hyperperfusion~     leading to proteinuria and glomerulosclerosis, as noted in obese dogs. In humans,~     improvements in renal function may be observed following bariatric surgery, although some~     reported a possibility of increased nephrolithiases. Whether biliopancreatic diversion and~     gastrectomy alone have similar effects is uncertain. More prospective studies are needed to~     assess the impact of all types of weight loss surgery to reverse chronic renal insufficiency.~      The objective of this study is to document changes in microalbuminuria and metabolic~     parameters in patients with altered renal function undergoing bariatric surgery. Patients~     enrolled in the study will show renal function impairment as demonstrated by~     albumin/creatinine ratio alterations in 2 out of 3 measurements taking place before surgery.~     We will perform a prospective study of renal function markers (albumin/creatinine ratio) and~     metabolic parameters (blood lipids, glucose, insulin, inflammatory markers) before and 6, 12,~     24 months after surgery in patients with microalbuminuria at study onset (albumin/creatinine~     ratio 2.0-20.0 mg/mmol in men and 2.8-28.0 mg/mmol in women). Data will be analysed with~     repeated measures analyses in both subgroup. Thereafter, a linear regression model will be~     created to adjust for potentially confounding factors such as hypertension and diabetes. We~     hypothesize that patients with severe obesity and altered renal function, whether they are~     diabetic or not, have improved microalbuminuria and metabolic parameters following~     biliopancreatic diversion with sleeve gastrectomy or sleeve gastrectomy alone. The extent of~     renal function recovery will correlate directly with metabolic improvements.~   "
114494|NCT02068820|"~     The investigators hypothesis is that if sensitivity and specificity are found to be~     significantly higher than the current reports with Technesium-99 and ISB colorimetric dye,~     SLN biopsies might allow omission of full lymphadenectomy in lower-risk cases, thereby~     limiting peri-operative morbidity. SLN biopsies might also improve the detection of~     metastatic disease, essentially lowering the recognized false-negative rate of standard~     lymphadenectomy analyzed by routine H&E pathologic analysis.~   "
114495|NCT02068807|"~     The balance of the redox state is important for normal embryonic and fetal development .~     During the perinatal period, a variety of conditions are responsible for an excessive~     production of free radicals. The following oxidative stress is exacerbated by a lack of~     antioxidant substances that have not yet matured. At the moment there are no therapeutic~     strategies with single or combined antioxidants that have been shown to be clinically~     effective.~      Breastfeeding is important for the contribution of the antioxidant defenses of the newborn~     and the nutritional status of the mother plays a key role because it influences the~     nutritional status of the newborn. Lutein is a carotenoid that is not produced by the body ,~     but taken with food or supplements. The molecule carries out different activities :~     antioxidant, anti-inflammatory, anticancer , neuroprotective. Its main activity of inhibition~     of peroxidation of membrane lipids is peculiarly important for the photoreceptors and neurons~     whose membranes are rich with polyunsaturated fatty acids. Current evidence on its role as an~     antioxidant indicate that supplementation with lutein may play a significant role in the~     prevention of free radical disease in the newborn~   "
114497|NCT02068781|"~     Currently, the incidence of obesity and obesity-related disorders is reaching epidemic~     proportions, which entails an increasing burden for health care systems. The association of~     obesity with other risk factors for type 2 diabetes mellitus and cardiovascular disease, such~     as insulin resistance and hypertension, is often referred to as the metabolic syndrome.~     During recent years, salt-sensitivity of blood pressure has emerged as an additional~     cardiovascular risk factor that is related to obesity and other key components of the~     metabolic syndrome. The underlying pathophysiological mechanisms of these interrelationships~     are complex and incompletely elucidated. Microvascular dysfunction has been proposed as a~     link between insulin resistance and hypertension in obese individuals. In addition,~     impairment of microvascular function was found to be associated with salt-sensitivity of~     blood pressure. Increased aldosterone levels, as observed in obese individuals, might be a~     cause of microvascular dysfunction-induced salt-sensitivity and insulin resistance.~     Aldosterone not only gives rise to sodium-retention in the distal tubule of the kidney, but~     was also found to impair endothelial function and thus lower NO-availability, which is~     characteristic of microvascular dysfunction. In addition, elevated aldosterone levels are~     associated with both hypertension and insulin resistance, which is illustrated in patients~     with primary aldosteronism, but also in the general population.~      The investigators hypothesize that increased aldosterone levels in obese individuals lead to~     impairment of microvascular function through reduction of NO-availability. This microvascular~     dysfunction is suggested to play a central role in the pathogenesis of salt-sensitive~     hypertension and insulin resistance.~   "
114498|NCT02068768|"~     The purpose of this prospective clinical study is to examine the short-term safety and~     efficacy of the Avenue®- L interbody Spinal Fusion System with VerteBRIDGE® plating to treat~     one and two level degenerative disc disease between L2 and S1 with a focus on fusion rate.~   "
114499|NCT02068755|"~     Blood transfusion is a common procedure essential for the treatment of patients undergoing~     cardiac surgery. Inappropriate transfusions, however, not only incur needless healthcare~     costs, but increase unnecessary risks due to transfusion reactions and infectious and~     immunomodulative causes. Safe and appropriate patient care requires evaluated blood component~     prescription practices.~      Practically all patients undergoing cardiac surgery in Finland have a blood product booking~     from the Finnish Red Cross Blood Service. This registry contains large volumes of~     transfusion-related information on all Finnish patients undergoing cardiac surgery in Finnish~     centers. Participating hospitals were scattered to all geographical areas in Finland and~     concentrated to the most populated regions.~      Data on the blood product use, laboratory findings one month pre-operatively and 12 months~     post-operatively were available.~      Finnish hospitals have been required to provide information on hospital visits for the~     Finnish National Research and Development Centre for Welfare and Health for healthcare~     planning purposes. We used in part the original data sent by hospitals to the Finnish~     Hospital Discharge Register (FHDR).~   "
114500|NCT02068742|"~     Interventional Study of Early Postoperative Cognitive Dysfunction in Elderly Patients~     Undergoing General Anesthesia~      The main purpose of this study is to determine the incidence of early postoperative cognitive~     dysfunction in elderly patients and its time course.~      This study will first evaluate the preoperative cognitive function of elderly patients based~     on several criteria including complete patient history, laboratory and instrumental exams,~     and the following measures in order to identify conditions and pathologies that may influence~     cognitive function.~        -  Mini Mental State Examination~        -  Geriatric Index of Comorbidity~        -  Geriatric Depression Scale~      The following neuropsychological tests will be performed on the same day within 7 days of~     surgery (baseline):~        -  Trail Making Test B-A~        -  Digit Span~        -  Digit Symbol Substitution Test~      The three cognitive function assessments will be repeated at the following postoperative time~     points and the change from the preoperative baseline to each time will be evaluated:~        -  Day 2 (time point 1)~        -  Day 4 (time point 2)~        -  Between days 85 and 90 (time point 3)~      If the patient seems confused before the postoperative administration of these tests, the~     Neecham Confusion Scale will be used to evaluate the patient for the presence of~     postoperative delirium; if delirium is not detected, the cognitive function tests will be~     administered.~   "
114501|NCT02068729|"~     An evaluation of the incidence of complications resulting from far lateral spine surgery~     utilizing the K2M RAVINE® Lateral Access System (RAVINE) with ALEUTIAN® Lateral Interbody~     Spacer System versus literature reported results for the NuVasive XLIF® system (XLIF) in the~     treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis.~   "
114502|NCT02068716|"~     Our Aim is to identify patient risk factors and clinical practices associated with~     healthcare-acquired infections (HAIs) after cardiac surgery.~      We will use prospectively collected data housed within the MSTCVS-QC (Michigan Society of~     Thoracic & Cardiovascular Surgeons Quality Collaborative) to reveal risk factors that elevate~     a patient's risk of developing HAIs. The results of this analysis will form the foundation~     for the development of standardized regional practices to reduce HAIs. We will explore the~     effect of traditional patient-level measures (age, sex, comorbid conditions), process~     measures (timing and selection of antibiotics, continuous insulin infusion, transfusions),~     and surgical practices (use of bilateral internal mammary artery usage among diabetics, vein~     harvesting approach).~   "
114503|NCT02068703|"~     To demonstrate whether use of sleep enhancing aids (face mask, ear plugs or white noise~     machine) in hospitalized patients can positively affect subjective symptoms of sleep quality,~     fatigue and pain.~   "
114504|NCT02068690|"~     To investigate safety, tolerability, and pharmacokinetics of BI 425809 following single~     rising doses of BI 425809 in healthy male volunteers; To explore dose proportionality of BI~     425809 as oral drinking solution; To investigate relative bioavailability of BI 425809 oral~     drinking solution fasted compared to BI 425809 tablet fasted and tablet fed~   "
114505|NCT02068677|"~     1. To evaluate the efficacy of EUS-CPN in subjects who experience a sympathetic response~     during injection when compared with subjects who do not experience sympathetic response~     during injection.~      EUS-CPN when performed in subjects who experience a sympathetic response during injection~     will have better pain relief when compared to subjects who do not experience a sympathetic~     response during injection.~   "
131012|NCT01852513|"~     The investigators hypothesize that treatment with QNASL will reduce nasal mucosal~     inflammation induced by the allergy season and prevent the changes in the microbiome caused~     by the allergy season.~   "
114508|NCT02068638|"~     Whereas physical activity clearly results in improvements in glycemic control in type 2~     diabetes, in individuals with type 1 diabetes (T1DM) the impact of exercise on blood sugar~     control is more complex. In type 1 diabetes T1DM the inability to reduce exogenous insulin~     levels during exercise is a key factor that contributes to an increased risk of~     exercise-induced hypoglycemia. Since rapid adaptation of insulin dosage may be especially~     difficult in patients on a multiple daily injection regimen, alternative strategies are~     required to improve exercise-associated glucose stability. There is increasing evidence that~     the combination of steady state continuous low to moderate intensity exercise with short~     bursts of high intensity exertion (eg in the form of sprints) is an effective, well~     tolerated, novel strategy to prevent exercise-related hypoglycemia. A further promising~     option to stabilize blood sugar levels during and after exercise may be the ingestion of~     fructose in addition to glucose in form of a sport drink.~   "
114509|NCT02068625|"~     This randomised, double-blind, placebo-controlled clinical trial investigates the~     neuroprotective effect of rasagiline in patients suffering from a retinal detachment~     affecting central vision. Based on results from a study in mice suffering from retinal~     degeneration, the investigators hypothesize that rasagiline delays neurodegeneration in the~     retina and improves visual acuity outcomes after retinal detachment surgery. Rasagiline is a~     second-generation propargylamine with neuroprotective properties modulating the~     caspase-dependent pathway of programmed cell death.~   "
114510|NCT02068612|"~     Physiological and neurocognitive changes experienced as a result of increasing age may~     influence socioemotional functioning and economic behaviors, yet, the mechanisms through~     which these changes occur are not well understood. Studies have also shown that aerobic~     exercise may protect against age-related cognitive decline in other domains. This research is~     designed to test the hypothesis that aerobic exercise will enhance social, emotional and~     economic functioning in older adults, and that these effects will occur via the effect of~     exercise on neurocognitive structure and function assessed via magnetic resonance imaging~     (MRI). Advancing our knowledge of the mechanisms that influence emotional, social and~     economic functioning could inform the development of targeted treatments and prevention~     programs for older adults.~   "
114511|NCT02068599|"~     The primary purpose of the study is to evaluate the change from baseline after 4 weeks of~     topical administration of TV-45070 (4% and 8% ointment) compared with placebo for the relief~     of symptoms of primary OA affecting a single knee~   "
114512|NCT02068586|"~     This randomized phase II trial studies how well sunitinib malate or valproic acid works in~     preventing high-risk uveal (eye) melanoma from spreading to other parts of the body.~     Sunitinib malate may stop the transmission of growth signals into tumor cells and prevents~     these cells from growing. Valproic acid may change the expression of some genes in uveal~     melanoma and suppress tumor growth.~   "
114513|NCT02068573|"~     AsthmaVent is a multi-center study, investigating the association between indoor air quality~     and childhood asthma.~      In Denmark, we spend more and more time indoors. Our houses are built airtight to save energy~     and are difficult to ventilate. We are thus more exposed to our indoor air than ever before.~     We know that indoor air contains many different components that can affect our airways~     inappropriately and particularly children with asthma, who have sensitive airways are~     sensitive to these components. The AsthmaVent project examines whether increased ventilation~     is able to improve the indoor environment to such an extent that the asthma disease control,~     for children with asthma and house dust mite allergy improves, resulting in need for less~     medication.~      Previous studies have pointed towards a beneficial effect of mechanical ventilation, on both~     the indoor air quality and on children's health and quality of life. There is not currently a~     consensus in this area, as studies so far have not been large or good enough to confidently~     determine the effect.~      This project is big and is designed so that it takes into account the sources of error seen~     in previous studies on the topic.~      We include, over a 3-year period (2012-2014), a total of 80 children with asthma and house~     dust mite allergy aged 6-18 years, from pediatric departments in Aarhus, Odense, Kolding,~     Randers and Herning. They are divided into two groups, receiving either active ventilation or~     placebo ventilation, meaning a non-functioning ventilation system that just recirculates the~     air in the room. Ventilation systems are installed in the fall and winter and ventilate the~     child's bedroom during 9 months. Indoor air quality and asthma control are assessed every 3~     months, both at home visits were air quality and allergen levels of house dust mites are~     studies and at visits to the outpatient clinics with control of asthma parameters and quality~     of life.~      The project involves collaboration between several institutions with an interest in indoor~     air quality in relation to allergies and asthma and with great expertise in the field.The~     project was initiated by CISBO (Centre for Indoor Environment and Health in Dwellings), a~     center consisting of several institutions in Denmark dealing with indoor environment:~     Department of Public Health at Aarhus University and University of Copenhagen, Danish~     Building Research Institute and the Technical University of Denmark.~      Since asthma is the most common chronic childhood disease in Denmark and since the~     development of allergies and asthma has high social and personal costs, it is important for~     both society and the individual family, to find out whether simply improving the indoor air~     quality by increased ventilation can lead to an improvement in asthma disease control.~   "
114514|NCT02068560|"~     There is substantial evidence that women throughout life have significantly lower plasma~     levels of the antidiuretic hormone vasopressin (pAVP) compared to men. The importance of this~     is not yet fully elucidated, but in relation to the observations of lower pAVP levels, no~     significant difference in renal response parameters was found. This could be interpreted an~     increased renal sensitivity in females compared to males. The theory of increased renal~     sensitivity in females is supported by a few pharmacodynamic studies currently available on~     this topic. However none of the studies was designed with the purpose of investigate the~     gender difference.~      The aim of this study is to investigate possible gender differences in the renal sensitivity~     to dDAVP and the effect of age on these differences. This will be done by low dose graded~     infusion of the synthetic AVP analog dDAVP.~      Participants are 80 healthy volunteers equally distributed between four age groups, 8-10~     years of age, 16-18 years of age, 25-40 years og age and 65+ years of age.~   "
114515|NCT02068547|"~     The purpose of this research is to test if that combining bone marrow aspirate (removing bone~     marrow with a needle) concentration with locally harvested (collected) autograft (patient's~     own bone from another part of the body) for use as the bone graft results in equal rates of a~     successful procedure (fusion), as compared to current best practice in high-risk patients~     undergoing posterior cervical fusion.~      Hypothesis: Bone marrow aspirate concentration combined with locally harvested autograft~     results in equivalent rates of bony fusion, as compared to current best practice in high-risk~     patients undergoing posterior cervical decompression and fusion.~   "
114516|NCT02068534|"~     The current study aims to explore the risk factors, protective factors, resilient factors,~     and factors jeopardizing the recovery progress on survivors from charcoal-burning suicide. To~     this end, an in-depth individual interview and Mini-Mental State Examination(MMSE) will be~     used to acquire the first-hand information on the attempters. As well, a more comprehensive~     neuropsychological test, WAIS III, will be administered at 3-month, 6-month, and 12-month~     after the index suicide attempt.~   "
114517|NCT02068521|"~     Protocol 13VR3 is is a multi-center, open-label study assessing long-term somavaratan~     administration.~      Patients will be monitored for safety throughout their participation in the study. Safety~     will be monitored by physical examination, inspection of injection sites, vital signs,~     clinical laboratory determinations (including fasting glucose, insulin, and lipids), 12-lead~     ECGs (for new treatment naïve subjects and subjects not previously exposed to somavaratan),~     PK/PD assessments, and immunogenicity assessments.~      Adverse events (AEs) and concomitant medications will be captured. AEs will be coded using~     CTCAE v 4.0. AEs will be coded using the MedDRA dictionary and CMs using the WHO Drug~     dictionary.~   "
114518|NCT02068508|"~     The purpose of this study is to investigate the safety and efficacy of long-term treatment~     with pioglitazone (Actos Tablets) in in the routine clinical setting in combination with~     combination with an insulin product in patients with type 2 diabetes mellitus who responded~     inadequately when using an insulin product in addition to diet therapy and exercise therapy.~   "
114519|NCT02068495|"~     This study will investigate the safety and efficacy of long-term use of candesartan~     cilexetil/amlodipine combination tablets (Unisia Combination Tablets) LD, HD in patients with~     hypertension in the normal clinical setting.~   "
114520|NCT02068482|"~     Diverticulosis of the colon is a frequent condition in adults in western countries and a~     significant number of patients experience clinical symptoms even when the diverticulosis is~     not complicated by diverticulitis.~      Both central and mucosal immunity are altered in Uncomplicated Symptomatic Diverticular~     Disease (USDD) and Rifaximin ameliorate clinical symptoms and normalize the immunological~     abnormalities.~      The Study Protocol is verify the modifications in the immunological pattern induced by~     reducing bacteria related activation of immunity by Rifaximin treatment.~   "
114521|NCT02068469|"~     The purpose of this trial is to show the accuracy and specificity of the Liat analyzer and~     assay for detecting Strep A at the point of care lab compared to culture.~   "
114522|NCT02068456|"~     The purpose of this study is to evaluate the safety and efficacy of roflumilast in the~     real-use conditions with its registered indications.~   "
114523|NCT02068443|"~     The purpose of this study was to evaluate the efficacy and safety of 24-week treatment with~     metformin hydrochloride 500 mg once daily added on to alogliptin (SYR-322) 25 mg in type 2~     diabetic patients with inadequate glycemic control despite treatment with alogliptin 25 mg in~     addition to diet and exercise therapy.~   "
114524|NCT02068430|"~     This study will evaluate the Safety and Effectiveness of the UV-X System for Corneal Collagen~     Cross-Linking in Eyes with Corneal Infection. The treatment of UV-X system is to use the~     eyedrops of the riboflavin, also known as vitamin B2, and ultraviolet A (UVA) light. The eye~     drops are placed in affected eye and then affected cornea is exposed to UVA.~      UVA/riboflavin corneal collagen cross-linking was first used to treat patients in 1998 in~     Dresden, Germany. Data to date obtained mostly by physicians outside the United States has~     strongly suggested this treatment as an acceptable alternative, and many subjects have had a~     lasting effect (no progression) 3-5 years after their initial treatment.~   "
114525|NCT02068417|"~     The objective of the pilot study is to assess the feasibility of a full randomised,~     placebo-controlled clinical trial.The aim is to demonstrate that penile shockwave application~     in patients with erectile dysfunction of vascular origin leads to a greater increase in~     potency than in the control group.~   "
114526|NCT02068404|"~     Preterm birth is the leading cause of perinatal mortality and morbidity. According to WHO, 15~     million children are born prematurely (gestational age < 37 weeks) in the world each year~     while 7% of them die because of complications associated with prematurity. Despite constant~     improvement of obstetrical care, the number of preterm births has increased over the last~     decades and prematurity is still the most frequent cause of prenatal hospitalization in~     industrialized countries.~      The American College of Obstetricians and Gynecologists as well as the Royal College of~     Obstetricians and Gynaecologists recommend nifedipine as a first-line tocolytic in case of~     acute threatened preterm labour. Clinical experience show however an important variability in~     treatment response among pregnant women. In spite of its large use in obstetrics as a~     tocolytic agent, nifedipine is prescribed off-label. As a consequence no international~     consensus on optimal dose schedule has so far been proposed.~      Small sample size and heterogeneousness of tocolysis administration protocols make it~     difficult to compare the little data available on the pharmacokinetics of nifedipine in~     pregnant women. Nevertheless an important interindividual variability in concentrations has~     been identified (CV=12-76%) but very few studies have investigated the possible reasons of~     this variability in pregnant women. Genetic and environmental factors involved in drug~     distribution and metabolism (e.g. enzymatic activity, CYP 3A5 genotype) might partially~     explain variability in drug levels and therefore differences in treatment response.~      The goal of this study is to quantify the variability in nifedipine pharmacokinetics and~     identify potential genetic and non-genetic sources of variability in nifedipine~     pharmacokinetics in pregnant women. The relationship between concentration and treatment~     response will be evaluated and will serve to propose optimal dosage regimen to improve~     efficacy and reduce side effects associated with this treatment.~   "
114527|NCT02068391|"~     Silent ischemic, also known as covert stroke vascular disease (CSVD), contributes to~     neurological deficits that are caused by damage to small blood vessels in the brain. CSVD~     occurs six to ten times more often that an acute stroke. It is misleading to think, however,~     that CSVD is an inevitable part of getting old because people with CSVD are at high risk of~     developing an acute stroke or dementia. In fact, people with more CSVD lesion volume are more~     likely to develop day to day problems in planning, decision-making and speed of thinking.~     Unfortunately, there are no proven therapies designed to address CSVD. We propose to test~     whether aerobic exercise is an intervention that can combat CSVD because the disease is~     fundamentally a blood flow problem that may be improved by aerobic exercise. We will recruit~     CSVD adults with moderate to severe lesion burden and use magnetic resonance imaging (MRI) to~     study the brain in terms of structure, perfusion and function. Participants will be randomly~     assigned to either our established aerobic exercise program or a control stretching program.~     Both groups will take part in lab exercise sessions, which are designed to monitor progress~     and assess adherence to the program. The duration and intensity of their exercise will~     increase as participants progress. We will use activity log books, phone calls and extra~     booster exercise sessions, as needed, to maximize retention and adherence. We aim to show~     that aerobic exercise increases cerebral blood flow (CBF) in frontal-subcortical grey matter,~     supports regional tissue growth, and improves cognitive function in CSVD adults with~     substantial risk of acute stroke and dementia. A positive outcome of this research will~     provide strong support for additional clinical trials aimed at sustaining cognition and~     maintaining independent living.~   "
120090|NCT01995643|"~     The proposed study aims to investigate that consumption of grape seed extract (GSE) would~     improve antioxidant status and impaired insulin action following consumption of a~     pro-oxidative high carbohydrate, high fat (HCHF) meal in healthy human subjects.~   "
114528|NCT02068378|"~     Lung cancer is the second most common cancer in the United Kingdom with around 40,000 new~     cases diagnosed every year. Lung cancer is associated with a very poor prognosis (<10%~     patient survival at 5 years). New strategies are urgently needed to improve survival in this~     group of patients.~      The most effective and common treatment for lung cancer is radiotherapy (either alone or~     combined with chemotherapy and/or surgery) and generally high doses of radiotherapy are given~     to the tumour. However, increasing the radiotherapy dose carries an increased risk of damage~     to the surrounding healthy tissue. Damage can be minimised by reducing movement within the~     lung, caused by factors such as breathing and patient motion, during treatment.~      This study tests a new medical device that has been developed to monitor and help patients~     control their breathing and movement during treatment. Optical sensors will detect any motion~     of the patient's torso and this will be fed back to the patient in the form of a visual aid~     allowing them to regulate their breathing and maintain their ideal treatment position.~      The device has already been shown to reduce motion in healthy volunteers. In this study the~     investigators hope to demonstrate that the visual aids are tolerable in lung cancer patients.~     The investigators additionally aim to show the device will help reduce movements of the chest~     and also the lung tumour, leading to improvements in treatment results.~   "
114529|NCT02068365|"~     This is a multi-center, single-arm, open-label study on the virological response of chronic~     HBV infection to pegyinterferon-alfa-2a among patients who achieved HBeAg seroconversion on~     nucleos(t)ide analogue (NA) treatment. The primary endpoint of this study is to investigate~     the sustained response (HBeAg seroconversion with HBV DNA <2000 IU/ml) to peginterferon at 24~     weeks after the end of treatment.~   "
114530|NCT02068352|"~     The purpose of this study is to investigate the effectiveness and safety of 2 concentrations~     of OPA-15406 compared to vehicle in subjects with atopic dermatitis.~   "
114531|NCT02068339|"~     Dithiolethiones, a novel class of adenosine monophosphate-activated protein kinase (AMPK)~     activators, prevent insulin resistance through AMPK-dependent p70 ribosomal S6 kinase-1~     (S6K1) inhibition. And it is well known that the modulation of S6K1 by oltipraz inhibited the~     development of insulin resistance and hyperglycemia through the AMPK-S6K1 pathway.Also some~     research reported that LXRg (a member of the nuclear hormone receptor)-mediated increases in~     SREBP-1c (the sterol regulatory element-binding protein-1c gene) promote the expression of~     lipogenic genes and enhance fatty acid synthesis and oltipraz inhibits LXRg and SREBP-c.~     Therefore, Oltipraz inhibits fatty acid synthesis through AMPK-S6K1 pathway and LXRg-SREBP-1c~     pathway in liver.~   "
114532|NCT02068326|"~     Background: Although it is now possible to diagnose Borderline Personality Disorder (BPD) in~     adolescents younger than 18 years according to the Diagnostic and Statistical Manual of~     Mental Disorders, 5th edition (DSM-V), and studies indicates that BPD can be reliably~     diagnosed in adolescence, only a few evidence based treatment programmes for adolescent BPD~     exists. Mentalization-based treatment (MBT), including group psychotherapy, has repeatedly~     shown to be effective in treating adult BPD, but in the case of adolescents, only individual~     MBT have been tested and found to be effective.~      Aims/hypotheses: We will test whether group based MBT (MBT-G), including an introductory~     programme for patients (MBT-I) and their parents (MBT-P) is more effective than Treatment As~     Usual (TAU) in treating adolescents with BPD or subthreshold BPD.~      Methods/Design: 112 patients referred to child and adolescent psychiatric clinics in Region~     Zealand will be randomized to either MBT or TAU. Inclusion criteria: Meeting DSM-V~     BPD-criteria at the threshold (five criteria) or sub threshold level (4 criteria). Follow-up~     will be at three and 12 months.~      Discussion: Early intervention is especially important in relation to personality~     psychopathology and has long-term benefits for patients, their families and society. In~     addition to being cost effective, using the group modality in the treatment of BPD may have~     several advantages. This is the first Randomized Controlled Trial (RCT) to test the~     effectiveness of MBT in groups for adolescents.~   "
114533|NCT02068313|"~     Phase II and III studies have demonstrated IMRT to be safe and standard practice for head and~     neck cancers treated with radiotherapy. This study will be an extension to an earlier,~     in-house, trial to allow continued recording of toxicities and outcomes in patients receiving~     IMRT for head and neck cancers. This study will allow us to examine radiobiological modelling~     for normal tissue complication probability and in particular, determining the dose threshold~     for parotid glands. Our primary objective is to assess the potential effectiveness of~     intensity-modulated radiotherapy (IMRT) in reducing xerostomia in head and neck cancer~     patients and determining threshold dose for whole parotid gland and superficial lobes of~     parotid glands~   "
114534|NCT02068300|"~     The purpose of this study is to evaluate the usefulness of plasma 1,5-anhydro-D-glucitol~     (1,5-AG) as a novel surrogate marker of hypoglycemia~   "
114535|NCT02068287|"~     Beta adrenergic system, over-activated in septic shock patients, is a key modulator of the~     inflammatory response. Experimental works demonstrated that Esmolol, an highly selective~     beta-1 blocker, reduces heart rate and regulates the inflammatory response. A recent mono~     centric, double blind, randomized clinical work in septic shock patients has shown that~     Esmolol administration is safe and reduces effectively heart rate. However there are only~     sparse data on 1) regional and micro-circulation, 2) inflammation modulation in human~     resuscitated septic shock patients treated by esmolol.~   "
114536|NCT02068274|"~     Opioids are an effective instrument for patients with acute and chronic pain. Their route of~     administration ranges from transdermal to subcutaneous application through to Intravenous~     Patient-Controlled Analgesia (IV-PCA).~      The use of IV-PCA-pumps has considerable advantages including decreased delay in the~     administration of opioids from the time requested, individual dose intervals, self -control~     of their therapy, rapidity and ease of dose titration . These potential benefits, however are~     balanced by the need for careful assessment of adverse effects, including decreased quality~     of life because of the patient's sedation, constipation and possible episodes of bradypnoea~     and desaturation, eventually leading to respiratory depression (RD) requiring treatment.~     Often described safety features that help prevent overdosing are PCA bolus dose, delay, and~     lockout interval.~      Even though the risk of serious, potentially life threatening complications by using IV-PCA~     without a background infusion was described to be very low (0.24%) compared to other methods~     of opioid delivery , adverse effects like worrying degrees of hypoxemia and bradypnoea do~     occur and often remain undetected due to the lack of continuous monitoring. One of the~     possible causes of patient harm are medication errors associated with PCA administration, a~     common form of PCA errors, which is a significant source of preventable patient morbidity and~     hospital resource utilization.~      The individual patient response to a particular dose of opioids depends on diagnosed or~     unrecognized comorbidities. Clinical experience has shown that it is not possible to~     prospectively identify all patients who may be at increased risk.~      Conventional opioid monitoring protocol may fail to detect frequent episodes of bradypnoea~     and desaturation measured by the respiratory rate (RR) and Saturation of Peripheral Oxygen~     (SpO2) because even at a low respiratory rate SpO2 is usually maintained, so that pulse~     oxymetry might fail to detect respiratory deterioration, particularly if a patient is~     receiving supplemental oxygen.~      Therefore, continuous monitoring could be considered more sensitive, especially if it~     contains the measurement of Partial Pressure of Carbon dioxide (PCO2), which is a good~     parameter for monitoring ventilatory function.~      The 'gold standard' method to measure the arterial partial pressure of carbon dioxide (PaCO2)~     is still the arterial blood gas analysis. But arterial sampling including catheterization or~     intermittent arterial puncture is invasive and expensive and associated with pain and~     discomfort for the patient. Therefore cutaneous carbon dioxide tension (PcCO2) measurement~     was suggested to be used as a non-invasive surrogate measure of PaCO2.~      SpO2, and tcPCO2, are important clinical parameters that should be used in conjunction with~     each other. SpO2 reflects oxygenation, while tcPCO2 reflects ventilation; the first can still~     be normal while the second may herald early changes in respiratory status. Capnography may~     provide the earliest indication of opioid-induced respiratory depression. It is important to~     monitor changes from a baseline tcPCO2 level. As the tcPCO2 level starts to increase, early~     intervention and changes in medication can be made.~      The present study aims to examine combined oxymetry and transcutaneous capnography using a~     single earlobe sensor (V-Sign™, Sentec AG, Therwil, Switzerland) in chronic pain patients~     treated with opioids where non-invasive monitoring of ventilation is needed because~     ventilatory disturbances are suspected. This may, potentially, improve patient's quality of~     life.~   "
114537|NCT02068261|"~     The purpose of this study is to evaluate the effects of a computerized working memory~     training program on substance abuse, psychosocial functioning, cognitive performance and~     psychiatric problems in adults with substance abuse and attention problems.~   "
114570|NCT02067832|"~     Chronic graft-versus-host disease (cGVHD) can be hard to diagnose, difficult to manage and~     contributes significantly to morbidity and mortality in hematopoietic stem cell~     transplantation patients.~      The research will look into identifying and validating cGVHD biological indicators~     (=bio-markers) which will be evaluated whether they can predict a future development of the~     disease.~      The study hypothesis is that a number of previously reported cGVHD bio-markers, known to be~     present at the time of cGVHD diagnosis, will also be present at earlier time points, before~     cGVHD develops.~      Following validation, the bio-markers will be beneficial for finding those patients who are~     in higher risk to develop cGVHD.~      By identifying the higher-risk group, which is more likely to develop cGVHD, a pre-emptive~     therapy might be applied in order to prevent or reduce the prevalence of the disease.~   "
114538|NCT02068248|"~     Research over the past several decades have linked the intake of dietary fiber with lower~     blood cholesterol levels. The distinction between soluble and insoluble fiber fractions~     emerged shortly after and there is now a general consensus that soluble fiber possesses the~     capacity to lower cholesterol. Since the discovery of the cholesterol lowering effects of~     soluble dietary fiber, there has been much debate as to the degree of cholesterol reduction~     from these fibers. In order to handle the inconsistencies a full and systematic review of the~     published literature was conducted by Brown et. al (1999). Results from this meta-analysis,~     concluded that 'increasing soluble fiber can make only a small contribution to lowering~     cholesterol.'~      Research is constantly progressing and new research findings may not always be consistent~     with older data. For example, results from new research are now challenging the previously~     approved health claims for soy foods and fatty acids. This is a major public health concern~     because if clinical evidence is not reliable, it could lead to harm. Since the publication of~     the meta-analysis by Brown et. al (1999) over a decade ago, scientists have continued to~     research the effects of soluble fiber on cholesterol levels with new technology and trial~     designs, therefore it is crucial to revisit the question and update the literature on the~     effect of viscous soluble dietary fibers on serum cholesterol levels.~      A series of meta-analyses will be performed to assess the link between viscous dietary fibers~     and serum cholesterol levels. Nutritionists now consider fiber to be an integral part of diet~     and disease. Results from these meta-analyses help address the question of whether viscous~     soluble fibers have a role lowering serum cholesterol levels.~   "
114539|NCT02068235|"~     This study consists of a single-dose pilot phase and a randomized, two-way crossover,~     single-dose main phase.The aim of this study is to evaluate the absolute bioavailability of~     the oral formulation (tablet) of ponesimod compared to an intravenous (i.v.) ponesimod~     formulation. Three subjects will be included in the pilot phase and 12 subjects in the main~     crossover phase.~   "
114540|NCT02068222|"~     The purpose of this study is to evaluate the safety and antiviral effect of ABT-450/r and~     ABT-530 coadministered with and without Ribavirin in adults with genotype 3 HCV infection.~   "
114541|NCT02068209|"~     The purpose of this study is to evaluate the role of Tramadol 50mg in reducing pain during~     outpatient hysteroscopy.~   "
114542|NCT02068196|"~     The goal of this study is to understand how ipilimumab is being used, its safety profile, and~     the manner in which Adverse Reactions are managed in routine clinical practice. Another goal~     is to identify predictive biomarkers. The study is an observational study and not intended to~     test any hypothesis, but can be hypothesis generating.~   "
114543|NCT02068183|"~     The proposed study builds upon preliminary studies in self-selected populations to identify~     opportunities for early identification of World Trade Center-related health consequences in~     adolescents. If adverse health consequences are identified, proactive cardiometabolic and~     pulmonary screening of exposed children may be indicated, with targeted interventions~     intended to prevent development of chronic obstructive pulmonary disease, and adverse~     cardiometabolic outcomes in adulthood.~   "
114544|NCT02068170|"~     A prospective, observational study in a university hospital (UZ Leuven). Patients are~     included when they are treated with a potentional QT-prolonging drug: haloperidol for~     delirium, antibiotics (moxifloxacin, levofloxacin, azithromycin, clarithromycin,~     erythromycin, co-trimoxazole), antimycotics (ketoconazole, itraconazole, fluconazole,~     voriconazole), methadone, tacrolimus and oral oncolytics.~      An ECG is taken before the administration of the drug and 3-5 days after starting the drug to~     investigate the change in duration of the QTc-interval. Risk factors for developing~     QT-prolongation will be documented. Together with ECG2, an additional blood sample will be~     collected to measure the blood concentration of the drug.~   "
114545|NCT02068157|"~     This phase II trial studies the effects of interstitial photodynamic therapy in patients with~     head and neck cancer that has come back. Interstitial photodynamic therapy uses a combination~     of laser light and a light-sensitive drug called porfimer sodium to destroy tumors. During~     treatment a laser light is used to activate the drug. Interstitial photodynamic therapy may~     be an effective treatment for head and neck cancer.~   "
114546|NCT02068144|"~     The purpose of this study is to determine the health benefits of cranberry extract in people~     who are at risk for diabetes and heart problems.~   "
114547|NCT02068131|"~     The purpose of this study is to evaluate the efficacy and safety of recombinant anti-tumor~     and anti-virus protein for injection plus capecitabine in treating patients with metastatic~     colorectal cancer who have progressed after standard therapy.~   "
114548|NCT02068118|"~     Targeted population: Patients with heart failure causing hospitalization during the last~     twelve months.~      Hypothesis: The number of all cause deaths and hospitalizations will be smaller for the~     Telecardiology group than for the reference group (standard follow-up care). An 18 months~     period of observation is required.~      Main goal: To compare the rate of all cause deaths and hospitalizations of patients with~     heart failure between the Telecardiology group and the reference group after 18 months of~     monitoring.~   "
114549|NCT02068105|"~     This is a study to test the safety of ALKS 5461 in healthy adults.~   "
114550|NCT02068092|"~     This is a pilot study is evaluating the effect of hydroxytyrosol, a component of Olive oil,~     on mammographic density in women at high risk of breast through assessing whether~     mammographic density is reduced in women at high risk of breast cancer taking hydroxytyrosol~     for 1 year compared with baseline imaging.~   "
114571|NCT02067819|"~     The purpose of this study is to assess the feasibility of a trial on an oral orthotic for~     reducing tic severity in children ages 7-25 years with Tourette syndrome (TS) or Chronic Tic~     Disorder (CTD).~   "
114572|NCT02067806|"~     The present study aims to evaluate the relationship between spinal block with 1% solution of~     2-chloroprocaine hydrochloride and the onset of all possible neurological adverse events,~     with particular attention to Transient Neurological Symptoms (TNS) and Cauda Equina Syndrome~     (CES).~   "
114573|NCT02067793|"~     The purpose of this study is to evaluate the efficacy and safety of NRX-1074 following a~     single intravenous dose in subjects with major depressive disorder.~   "
115819|NCT02051478|"~     The purpose of this randomized clinical trial was to examine the widespread effects of~     thoracic spine thrust manipulation and thoracic non-thrust mobilization on pressure pain~     sensitivity and neck pain intensity in patients with chronic mechanical neck pain.~   "
114551|NCT02068079|"~     The purpose of this study is to evaluate the safety of combination therapy with vemurafenib~     and trientine in patients with BRAF mutated metastatic melanoma.~      Vemurafenib is a drug that is currently approved by the United States Food and Drug~     Administration (FDA) and by the European Medicines Agency (EMA) to treat adult patients with~     melanoma that has spread to other parts of the body or cannot be removed by surgery. It can~     only be used in patients whose cancer has a change (mutation) in the BRAF gene.~      Preclinical data suggests that use of a copper chelator (reducer) is a strategy to block~     cellular signaling activity which would result in anti-tumor effects (slow tumor growth).~     Trientine is a copper chelator and is FDA approved for the treatment of Wilson's disease (a~     disease of copper metabolism) and is generally well tolerated. It works by binding to copper~     to help remove it from the body. Trientine is not FDA approved for the treatment of melanoma~     and its use in this study is investigational. Investigational means the study drug is still~     being tested in research studies.~      All patients will receive vemurafenib at 960mg PO twice daily with continuous dosing in~     combination with trientine in escalating doses. The dose of trientine will depend on what~     portion of the study.~      In order to participate in the study, patients must test positive for the change (mutation)~     in the BRAF gene.~   "
114552|NCT02068066|"~     Background: Physical activity is defined as any bodily movement produced by skeletal muscles~     resulting in energy expenditure (Caspersen, 1985). According to classical work physiology,~     energy expenditure was considered as basis for assessing the severity of manual work~     (Grandjean 1991). Steele et. al. found blue collar workers to report significantly more~     walking activity, daily step counts and MET min/week than professionals and white collar~     workers. However, the energy cost of physical activity may not necessarily be equivalent to~     body movement. Therefore, modern concepts include also other aspects reflecting the amount of~     workload. Soer et. al. applied an evaluation system consisting 12 work-related tests to~     establish functional capacity in healthy employees. The assessment included various lifting~     and energetic tasks as well as coordination exercises. In occupational rehabilitation a~     balance between workload and work capacity is necessary for professional reintegration. Thus,~     it is of great value to evaluate a wide range of work requirements across occupational groups~     in terms of energy expenditure, physical activity and aerobic capacity.~      Aim: The aim of this study is to examine the amount of physical activity and energy~     expenditure during a normal working day with focus on differences between occupational~     groups.~      Method: To analyze the situation in Switzerland, 300 healthy and full-time employed adults~     between 18-65 years will be investigated in the Basel region. Participants will be stratified~     by occupational category according to the ISCO-88 and will then be merged into 3 groups with~     low-, moderate- and high-intensity occupational activity. By wearing the SenseWear Mini~     Armband on 7 consecutive days, average daily energy expenditure, activity duration at~     different intensities and step counts will be assessed during work-time. In addition,~     individual's aerobic capacity will be determined by the 20-meter shuttle run test.~      Outlook: This study is expected to provide detailed information about physical work~     requirements with regard to professional reintegration. For developing adequate intervention~     and treatment strategies, it is of great value to evaluate performance criteria across~     occupational groups.~   "
114553|NCT02068053|"~     The purpose of this study is to assess the pharmacokinetics (PK), metabolism, routes and~     extent of elimination, as well as safety and tolerability of a single oral solution dose of~     [14C] Bristol-Myers Squibb (BMS)-986020 in healthy male subjects.~   "
114554|NCT02068040|"~     The major goal of this proposal is to characterize the ability of epicatechin which a~     component of dark chocolate to improve the~        1. structural and functional features of skeletal muscle (SkM)~        2. exercise capacity (as assessed by VO2 max)~        3. parameters of diastolic heart function (as assessed by echocardiography)~      We propose that a 3 month treatment with epicatechin (through CocoaVia® capsules) will lead~     to a significant improvement in exercise capacity and diastolic function.~   "
114555|NCT02068027|"~     The purpose of the study is to determine whether clonidine gel is an effective treatment for~     reducing the pain associated with painful diabetic neuropathy.~   "
114556|NCT02068014|"~     Sleev gastrectomy is a procedure performed for permanent treatment of obesity. For the~     procedure, cutting of the stomach is performed with differents long of stapplers.~      The aim of the study is to determine wich long of stappler is applicable in any stage of the~     procedure ans the variation expected.~   "
114557|NCT02068001|"~     It has been suggested that obese people are more sensitive to sensory and rewarding effects~     of food, aspects that mediate food preferences and intake. Individuals that underwent~     Roux-en-Y gastric bypass surgery frequently report changes in food preference. They indicate~     a decreased preference for highly rewarding energy dense foods. Changes in food preference~     might be related to alterations in central (brain) mechanisms, related to reward sensing. The~     smell and sight of food can be considered as anticipatory cues for the rewarding effects of~     food intake. The aim of this study is to determine the effect of gastric bypass surgery on~     (alterations in) food preferences. Secondly, this study aims at assessing the effect of~     gastric bypass surgery on the brain reward response when exposed to sight and smell of food~     stimuli with different sugar and fat contents.~   "
114558|NCT02067988|"~     Patients with gastroenteropancreatic neuroendocrine tumours (NET) often die from intrahepatic~     disease or are excluded from liver-directed treatment because of extrahepatic disease.~     Adjuvant liver-directed treatment is warranted to control both intra- and extrahepatic~     disease. Patients with liver metastases of NET will be included in this study (n = 30-48).The~     efficacy and toxicity of adjuvant 166Ho-radioembolization (166Ho-RE) after systemic~     177Lu-dotatate will be studied in a non-comparative phase II study. The study is an~     interventional, treatment, non-randomized, open label, non-comparative, phase II study.~     166Ho-RE will be performed via a catheter during angiography.~   "
114559|NCT02067975|"~     Kynurenic acid (KYNA) is a naturally occurring chemical in the brain. Studies with rodents~     indicate that levels of KYNA can impact levels of the neurotransmitters glutamate and~     dopamine. One way to reliably increase KYNA levels is by ingesting the amino acid tryptophan.~     Tryptophan is a normal part of the human diet. Tryptophan gets metabolized/changed to other~     chemicals in the body- including KYNA. By giving people 6 grams of tryptophan, the~     investigators will be able to increase the KYNA level in a controlled way. The investigators~     will then be able to study the effects of KYNA on neurotransmitters by using cognitive tests~     and magnetic resonance imaging techniques (measuring brain activity and brain chemistry using~     the MRI magnet). They will test people using tryptophan and also using a placebo to look for~     differences. The investigators will test healthy controls and people with schizophrenia to~     look for differences.~   "
114584|NCT02067650|"~     Hardly any imaging studies specifically addressing the articular and periarticular structures~     in MPS patients are available at this point. The investigators propose to do for the first~     time a pilot study using musculoskeletal ultrasound in patients with various types of MPS.~   "
114560|NCT02067962|"~     Juvenile idiopathic arthritis (JIA) is considered to be a multifactorial disease caused by a~     combination of environmental factors and predisposing genetic factors. Twins studies found a~     strong heritability (strong genetic factors) but genetic studies such association studies of~     large cohorts of patient (GWAS or Genome Wide Association Study) have elucidated less than 20~     % of the genetic basis of JIA. The vision of the genetics of multifactorial diseases has~     recently changed revealing a large clinical and genetic heterogeneity of these diseases.~     Indeed, the advent of next-generation sequencing identified non-multifactorial genetic~     hereditary disease related to mutations in genes having strong effect on the onset of the~     disease without real impact of environmental factors among the so called multifactorial~     diseases (Parkinson's, diabetes, osteoarthritis, Alzheimer's, hypertension ...)The~     investigators propose to study 30 families with several forms of JIA by next-generation~     sequencing. Identifying the genetic basis of JIA in these families will help to better~     understand the physiopathology of this disease and may help to the identification of novel~     therapeutic targets for other patients with JIA.~   "
114561|NCT02067949|"~     determination of the effectiveness and the cost-effectiveness of simvastatin(Zocor 40 mg)~     plus standard therapy (SSCG)versus standard therapy alone in critically ill septic patient~     from the societal perspective over one year.~   "
114562|NCT02067936|"~     The investigators study whether four equipotent combinations of propofol and remifentanil (as~     predicted by interaction models for tolerance of laryngoscopy) result in identical~     haemodynamic conditions, independent of their relative different balance between the~     concentration of propofol and remifentanil.~   "
114563|NCT02067923|"~     This study proposes to conduct a non-interventional, multi-center trial that will look at~     C-peptide results from one or two Mixed Meal Tolerance Tests (MMTT) in participants who~     received anti-CD3 treatment or placebo on the Abate ITN027AI trial. Anti-CD3 monoclonal~     antibody is a humanized antibody that is commonly used to prevent organ rejection. It was~     give in order to determine whether anti-CD3 mAb treatment can halt the progression of newly~     diagnosed type 1 diabetes.~      The overall hypothesis of this study is there will be less change in c-peptide levels of the~     previously treated group versus the control group.~   "
114564|NCT02067910|"~     Primary Sjögren's syndrome (pSS) is a common chronic auto-immune disease, characterised by~     inflammation of the exocrine glands, resulting in progressive dryness of the eyes and the~     mouth. Furthermore, many patients experience extraglandular symptoms such as restricting~     fatigue. Currently, biological agents have been introduced in various systemic autoimmune~     diseases such as rheumatoid arthritis and systemic lupus erythematosus. No biological agent~     has yet been approved for the treatment of pSS. In an open-label study, we have shown that~     abatacept treatment of pSS patients has promising results (Meiners et al., 2014). Therefore,~     the aim of this study is to evaluate efficacy and safety of subcutaneous abatacept treatment~     in pSS in a larger and randomized clinical trial.~   "
114565|NCT02067897|"~     Ingrown toenails occur when the nail grows into the surrounding skin, resulting in pain and~     infection. The most common procedure to treat this problem is a wedge excision (removal of~     part of the toenail) and matricectomy (destruction of part of the nailbed with chemicals or~     surgical instruments). This study will evaluate the effectiveness of an alternative technique~     called the Vandenbos procedure (where the skin is removed and the toenail is left intact).~     This procedure is currently being used by some of the pediatric surgeons at our hospital and~     we want to evaluate our results up to 6 months after surgery. We believe that the true~     recurrence rate will be greater than 0% but that recovery time and morbidity will be~     acceptable to most patients.~   "
114566|NCT02067884|"~     This pilot clinical trial studies contrast enhanced ultrasound and shear wave elastography in~     measuring response in patients with breast cancer receiving chemotherapy before surgery. New~     imaging procedures, such as contrast enhanced ultrasound and shear wave elastography, may~     predict treatment response earlier and more accurately than contrast enhanced magnetic~     resonance imaging.~   "
114567|NCT02067871|"~     -  The purpose of this study is to determine the effects of low-level laser therapy in~          combination with neuromuscular electrical stimulation on neuromuscular (muscular~          strength and morphology) and functional parameters (pain and functional tests) in~          elderly with knee osteoarthritis.~        -  The hypothesis is that the association of low-level laser therapy with neuromuscular~          electrical stimulation could reduce joint pain associated with the inflammation and~          consequently potentiates the effects of electrical stimulation on the muscular system.~   "
114568|NCT02067858|"~     The goals of this clinical research are to evaluate the outcomes and tumor response for early~     stage non-small lung cancer (NSCLC) patients undergoing Stereotactic Body Radiation Therapy~     (SBRT) using four dimensional (4D) Positron Emission Tomography (PET) and Computed Tomography~     (CT), Cone-Beam Computed Tomography (CBCT), Real-Time Position Management (RPM™) and body~     immobilization system (see figure 1). Specifically, the effect of image-guided SBRT treatment~     on clinical tumor response rate, local control and progression-free survival will be studied.~     This study will examine target volumes and relevant margins determined by an assessment using~     4D PET and repeated 4D CT. These data will allow us to evaluate and determine the impact of~     the body immobilization system on the planning target volume (PTV) margins, patient's~     breathing pattern, target motion, and inter-treatment targets shifts.~   "
114569|NCT02067845|"~     The limited research that exists suggests that lesbian, bisexual and queer (LBQ) women are at~     similar risk for sexually transmitted infections (STI) as heterosexual women. This is a~     particularly important area to address, as literature highlights the convergence of sexual~     stigma and gender-based sexual violence as elevating LBQ women's risk for HIV and STI~     infection. However, recent Statistics Canada data indicated that: lesbians reported~     significantly lower rates of Pap testing than heterosexual or bisexual women; lesbians and~     bisexual women had higher odds of not having a regular doctor than heterosexual women; and~     bisexual women had higher reported unmet health care needs than lesbian and heterosexual~     women. These differences highlight the importance of implementing and evaluating~     interventions to address STI risk among LBQ women; however, no published study exists of this~     nature. A STI prevention intervention will be implemented with groups of LBQ women and WSW in~     Toronto and Calgary. The study has 5 distinct components: 1) key informant interviews to~     inform the development of the intervention training manual and survey questionnaire, 2)~     pre-test; 3) intervention (6 group sessions during a weekend retreat); 4) post-test directly~     following intervention, and 5) follow-up post-tests at 6 and 12 weeks. The study hypothesis~     is that, compared to pre-intervention, participants who receive the group-based intervention~     will report an increase in sexually transmitted infections (STI) knowledge post-intervention.~     The secondary hypotheses are that, compared with pre-intervention, participants will~     demonstrate higher mean scores of (a) safer sex self-efficacy; (b) STI testing; (c) safer sex~     practices; (d) resilient coping, (e) self-esteem, (f) social provisions, (g) community~     connectedness and (h) access to health care. We anticipated that compared to~     pre-intervention, participants post-intervention would report lower mean scores of (a)~     depression and (b) internalized stigma.~   "
114574|NCT02067780|"~     Chronic obstructive pulmonary disease (COPD) is one of the most common diseases in the world.~     In a recent study, we showed that administration of levofloxacin is superior to placebo in~     the treatment of decompensation of COPD; it is accompanied by a substantial reduction in~     mortality and a significant reduction in the residence time in hospital.~      In Tunisia, few data are available on the epidemiology of COPD decompensation. The choice of~     antibiotic to be used in this situation is challenging to the clinician who must choose~     between traditional antibiotics (cyclins, aminopenicillins, cotrimoxazole...) and new~     antimicrobial agents. Recently, it has been emphasized the selection of patients for~     treatment according to the degree of systemic inflammation (C-Reactive Protein). Indeed,~     there would have a correlation between the tracheobronchial infection and elevated~     inflammatory markers. As the elevation of these markers is proportional to the intensity of~     the inflammatory reaction of the body, is based on the kinetics of these biomarkers in~     antibiotic treatment seems logical. Thus, C-Reactive Protein allowed not only knowing when to~     start antibiotics, but also through their kinetic, these markers can guide the duration of~     therapy and shorten the duration of antibiotic therapy: a rate cut would ensure that the~     antibiotic treatment was adopted.~      The objectives of this randomized prospective and double blind study are to evaluate the~     efficacy and safety of a short treatment of 48 with levofloxacin compared with treatment with~     the same molecule during a time guided by monitoring markers of inflammation in patients~     admitted to the emergency for exacerbation of COPD and to study the epidemiology of viral and~     bacterial COPD decompensation.~   "
114575|NCT02067767|"~     Abacavir/Lamivudine + Nevirapine (ABC/3TC + NVP) is a very effective and well tolerable~     regimen on the long-term. However this regimen comprises 2 pills per day.~     Abacavir/Lamivudine/Dolutegravir (ABC/3TC/DTG) offers simplification with a single pill per~     day with no food constraints, Dolutegravir (DTG) having the advantage over Nevirapine (NVP)~     of high potency, higher genetic barrier to resistance, with a very good safety profile. The~     objective of this study is to evaluate the virologic safety (maintenance of virologic~     suppression) after switching from ABC/3TC + NVP to ABC/3TC/DTG in 50 HIV-1 infected adults~     with prolonged HIV RNA suppression on ABC/3TC + NVP, as well as clinical and laboratory~     safety. Because nevirapine is a strong inducer of hepatic enzymes, pharmacocinetic (PK)~     assessment will be performed in all patients in the first weeks after switch and 24-hours PK~     in a subset of 10 patients after 5 days of DTG addition to current regimen, before switching~     to ABC/3TC/DTG.~   "
114576|NCT02067754|"~     The investigators planned this study to Patients with histologically confirmed metastatic~     gastrointestinal cancer, genitourinary cancer , rare cancer with treated any anti-cancer~     therapy : Extra blood sample collection during routine blood sampling.~   "
114577|NCT02067741|"~     SAKK 21/12 is a stratified, multicenter Phase II first in-human trial with transdermal CR1447~     (4-OH-testosterone) and is directed to patients with endocrine responsive-HER2neg and~     TN-ARpos metastatic or locally advanced breast cancer.~      The trial will be conducted in Switzerland with max. 90 patients. CR1447 has a very good~     safety and tolerability profile and combines two mechanisms of action, interaction with the~     AR and the aromatase enzyme may have a higher activity than drugs with a single mechanism and~     might offer the possibility of non-chemotherapy based endocrine therapy to the limited~     treatment options in TN-ARpos BC. Transdermal application of CR1447 might have the advantage~     to continuously release of 4-OHT into the blood stream, thus omitting a first pass effect.~      In Phase II the main objective is to assess activity and to determine the efficacy and~     tolerability of CR1447. Phase II will consist of two strata, into which patients will be~     stratified according to their hormonal receptor status: Stratum A for patients with endocrine~     responsive-HER2neg disease, regardless of their AR status and Stratum B for patients with~     triple-negative and determined ARpos disease. Patients with triple-negative disease tested~     negative for AR will be excluded from the trial.~      In both strata patients will be treated with 400 mg of CR1447 until disease progression,~     patients' wish or physicians' decision to end treatment. Biopsies of one defined metastatic~     lesion in those patients who gave informed consent will be performed at baseline and within~     the third week of treatment with CR1447.~      Measurement of AR expression, expression of downstream targets of ERα, ERβ, PR, AR,~     angiogenesis and other translational studies as described in this protocol should help~     confirming the hypothesis of an increased benefit of CR1447 due to its dual action, efficacy~     of topical application, tolerability and in deciding whether one should proceed to a large~     randomized trial.~   "
114578|NCT02067728|"~     The main aim of the study would be to examine the effect of using a health behavior screening~     tool and a brief patient centered conversation on health behavior goal setting during~     well-child visits.~   "
114579|NCT02067715|"~     Thus, the aim of this study is to evaluate the sealed bleaching technique on tooth~     sensitivity and bleaching efficacy. The hypothesis is that the sealed bleaching technique~     reduce the tooth sensitivity when compared to conventional technique, without alters the~     bleaching efficacy.~   "
114580|NCT02067702|"~     Essential Tremor (ET) is characterized by tremors affecting the arms. The investigators will~     examine the effects of non-pharmacological limb cooling on clinical and physiological~     characteristics in patients presenting with ET at three different temperatures; and will~     measure changes in tremor amplitude after cooling of the upper limb.~   "
114581|NCT02067689|"~     This study will evaluate the influence of non-invasive brain stimulation on different~     elements of cognitive function in healthy persons between the ages of 18-90 years. It will~     specifically use transcranial direct current stimulation (tDCS) to evaluate the relationship~     between certain brain structures and cognitive abilities, like attention, working memory,~     visual search, etc.~   "
114582|NCT02067676|"~     The purpose of this study is to assess the safety of increasing doses of a potential vaccine~     against Campylobacter with and without Alhydrogel®, an aluminum hydroxide adjuvant. This~     study will also assess immune responses induced by the vaccine.~   "
114583|NCT02067663|"~     The intrauterine device (IUD) is a safe, highly effective, long acting, and reversible form~     of contraception. The postpartum period is an important moment for contraceptive~     intervention; however there are many barriers to women obtaining birth control postpartum.~     The use of the IUD in the immediate postpartum setting offers many advantages and is~     considered safe, but the risk of expulsion appears to be higher than with interval insertion.~     Previous studies have shown the rate of expulsion of the copper IUD in the postplacental~     period to be in the range of 1-14% by 6-12 months, while the only study of the levonorgestrel~     IUD in the postplacental period documented a rate of expulsion of 24% by 12 months. While~     studies related to the copper IUD use ring forceps or the operator's hand for placement of~     the IUD, the only published study investigating immediate postplacental levonorgestrel IUD~     insertion utilized the manufacturer's inserter for IUD placement. The investigators therefore~     ask the question, is there a difference in expulsion rates between levonorgestrel and copper~     IUDs placed post-placentally when all providers undergo a standardized training, use a~     standardized insertion technique, and when patient level characteristics are controlled by~     randomization?~      The investigators propose to perform a prospective cohort trial comparing the rates of~     expulsion for the levonorgestrel and the copper IUD by 3 months postpartum when placed in the~     uterus within 10 minutes of the delivery of the placenta, using a standardized technique~     (placement with a ring forceps or the operator's hand) after all providers undergo a formal~     didactic and skills training. The investigators hypothesis is that the levonorgestrel IUD has~     a higher rate of expulsion as compared to the copper IUD. Additional objectives include a~     comparison of the rates of complete IUD expulsion, partial IUD expulsion, unrecognized~     expulsions, complications, IUD continuation, pregnancy, and satisfaction. Additionally, the~     investigators will document the natural history of the location of the IUD within the uterus~     when placed in the immediate postpartum period, utilizing ultrasound at 24 hours, 6 weeks,~     and 3 months postpartum, to better understand the relationship between position of the IUD~     and subsequent expulsion.~   "
114587|NCT02067611|"~     This is a phase 2, multicenter, randomized, double blind (with dose), placebo controlled,~     parallel group, proof of concept, and dose range finding study to evaluate the efficacy,~     safety, and PK of X0002 spray in adult subjects with clinically symptomatic mild to moderate~     OA of the knee.~      Objectives of the study:~        1. To evaluate the efficacy of X0002 spray compared to placebo for relief of knee pain in~          subjects with osteoarthritis (OA) of the knee;~        2. To assess the safety and tolerability of multiple doses of X0002 when administered as a~          topical spray.~   "
114588|NCT02067598|"~     The purpose of this study is to determine the effect of scapular exercise on pain related~     parameters including pain intensity, 24 hours pain intensity, pressure pain threshold,~     anxiety and muscle tension in patients with scapulocostal syndrome.~   "
114589|NCT02067585|"~     Bariatric surgery induce remarkable weight loss and improvement or resolution of type 2~     diabetes. Obesity is the primary risk factor for type 2 diabetes, and 90% of all type 2~     diabetics are obese. Type 2 diabetes resolves post-operatively in 84-98% after bypass and~     48-68% after restrictive procedures.~      Obesity leads to elevated plasma free fatty acids and subsequently to excessive accumulation~     of triglyceride in peripheral tissues, which is an independent risk factor for insulin~     resistance and type 2 diabetes. Bariatric surgery is associated with dramatic decrease in~     plasma free fatty acids and other lipids.~      This study will clarify the relationship of changes in fatty acid and other lipid metabolism~     to improved insulin sensitivity after different bariatric procedures ('restrictive' -~     laparoscopic adjustable gastric band and 'hybrid' - laparoscopic roux-en-y gastric bypass)~     and compare them with non-surgical obese patients. This will allow the investigators to~     refine indications for these procedures especially in patients with type 2 diabetes.~      The investigators will analyze whether surgical bypass of the upper small bowel plays a~     critical role in the resolution of type 2 diabetes and improvement in lipid metabolism. The~     investigators will achieve this by comparing gastric banding and gastric bypass in a~     collaborative research study involving obesity surgeons, physicians and lipid researchers.~   "
114590|NCT02067572|"~     This study examines the effectiveness of an herbal mouthwash made from salvia in maintaining~     good oral health among patients in palliative care. It is hypothesized that using the~     mouthwash made from salvia will result in better oral health and more oral comfort than using~     with conventional normal saline mouthwash.~   "
114591|NCT02067559|"~     The main objective of the study is to test the feasibility of the ICU diaries intervention in~     the ICU. The investigators do not have sufficient power to detect differences in the~     hypotheses below, but will use the present pilot study to inform sample size required to~     adequately power a follow-up randomized control trial.~      (1) The investigators hypothesize that subjects exposed to a psychoeducation condition will~     have reduced rates of post-traumatic stress disorder (PTSD) compared to those experiencing~     treatment as usual (TAU). (2) The investigators hypothesize that compared to participants in~     the psychoeducation and TAU groups, those subjects exposed to an ICU diary, and those exposed~     to both ICU diary + psychoeducation conditions, will have significantly reduced rates of PTSD~     at follow-up. (3)The investigators hypothesize that participants exposed to the ICU diary +~     psychoeducation condition will have significantly lower rates of PTSD compared to those in~     the ICU diary alone condition.~   "
114592|NCT02067546|"~     Emptying disorders are of the most common causes of constipation. An adjustable toilet seat~     was designed by  Shva-Nach Ltd company, and is designed to facilitate the angle sitting~     position.~      Its efficacy will be evaluated in the current study, on 50 volunteers who suffer from~     constipation and meet the Rome 3 criteria for constipation.~   "
114593|NCT02067533|"~     The purpose of the present study is to determine the influence of position of soft tissue~     repair (flexion versus extension) in post operative range of motion(ROM) and functional~     outcome in patients who underwent primary total knee arthroplasty (TKA).~   "
114594|NCT02067520|"~     Introduction:~      Cesarean section (C/S) is usually performed under spinal with preservative free morphine for~     pain relief, but the investigators have a severe shortage of this formulation of morphine.~     Hydromorphone is a narcotic which acts peripherally and centrally to decrease pain. It has~     been used in spinals for postoperative pain relief and in pain pumps for relief of chronic~     pain. No randomized controlled studies have evaluated intrathecal (IT) hydromorphone for post~     C/S pain.~      Methods:~      This is a randomized double-blind controlled trial utilizing the up-down sequential~     allocation method1,2 to find the best dose of IT hydromorphone that provides pain relief~     following C/S. Patients will be given a morphine PCA pump for additional pain relief. Our~     first patient will receive 200 mcg of IT hydromorphone. Pain, nausea, and itching will be~     evaluated at 4, 8, 12 and 24 hours following the C/S via numeric rating scales; vomiting and~     morphine use per hour will be recorded. Success will be a median morphine usage of less than~     or equal to 1mg/hour in the following 16 hours. If a success, the next patient will be given~     10 mcg less IT hydromorphone; if a failure, she will receive 10 mcg more. The study will end~     after 5 successes.~      Objective:~      The primary objective is to find the optimal dose of IT hydromorphone for pain relief~     following C/S. The secondary objectives are to define the incidence and severity of~     hydromorphone's side effects and determine the duration of analgesia.~   "
114595|NCT02067507|"~     The primary aim of the project is to increase human papillomavirus (HPV) vaccine receipt~     rates among low-income, ethnic minority adolescents (girls and boys 11-17 years of age) in~     Los Angeles County. We will accomplish this goal by implementing and rigorously evaluating~     interventions in multiple venues that serve our target population, including the Los Angeles~     County Department of Public Health (LACDPH) and two large Federally Qualified Health Centers~     (FQHCs).~      Our hypotheses are:~      Primary hypothesis:~        1. The intervention group will have a higher rate of HPV vaccine initiation at follow-up~          compared to the control group.~           Secondary hypothesis:~        2. The intervention group will have higher vaccine completion rates (3 doses) at follow-up~          compared to the control group.~   "
114596|NCT02067494|"~     The purpose of this current randomized clinical trial is to determine the effects of~     myofascial soft tissue release and kinesio taping on disability, pain, quality of life,~     autonomic nervous system and oxidative stress indicators in chronic low back pain.~   "
114597|NCT02067481|"~     This is a single-arm pre-post pilot study, to assess changes in weight, quality of life and~     cardiorespiratory fitness after a diet and physical activity intervention in breast cancer~     survivors and to asses possible relation between these changes.~   "
114598|NCT02067468|"~     Cervical cancer as well cervical preneoplastic abnormalities (CIN2+) are cause by human~     papillomavirus (HPV) infection. These abnormalities have been historically detected by~     cervical cytology, but recent evidence shows that HPV testing is superior to cytology to~     detect cervical lesions that eventually will progress to cancer. Despite evidence,~     conventional cytology (Pap) remains as a primary screening test in Colombia and HPV test is~     recommended as a triage test for women with atypical squamous cells of undetermined~     significance (ASC-US) in settings around the world. Women with ASC-US have low risk to CIN2+~     but higher than healthy population, and therefore it is important to provide appropriate~     clinical management. However, there is no consensus of how to deal women with ASC-US and~     therefore there are still three strategies for this purpose: 1) immediate colposcopy, 2)~     repeat conventional cytology at 6 and 12 months and 3) HPV testing. The main objective of~     this study is to compare the effectiveness and the efficient among the strategies as well as~     to evaluate the acceptability of the HPV testing in a real-life setting.~   "
114599|NCT02067455|"~     Heart failure is a public health problem, responsible for 150.000 admissions, 32.000 deaths,~     1% of public health expenditure each year in France. Heart transplantation remains the~     standard of care in patients for which medical therapy is not sufficient. But heart~     transplantation is a limited resource, as a result of donor shortages. It is therefore~     possible to consider mechanical circulatory support for patients awaiting heart~     transplantation or for those who are not suitable for transplantation. Left Ventricular~     Assist Devices (LVAD) are portable pumps which help the left side of the heart to provide~     appropriate cardiac output. in this type of device, right heart is not assisted and must~     work on its own, LVADs are thus implanted in patients whose right ventricular function is~     normal.~      The aim of the REVADE study is to assess right ventricular echocardiographic parameters in~     this population, especially on physical exercise, for a better understanding of right~     ventricular adaptation to this long-term modified pressure pattern.~   "
114600|NCT02067442|"~     Both intravenous and oral acetaminophen have been shown to reduce post-operative pain scores~     when given preoperatively. This study investigates if there is a difference between the~     intravenous and the oral forms when given preoperatively to patients undergoing lumbar~     microdiscectomy. We hypothesize that the intravenous formulation does not improve pain scores~     or decrease opioid consumption during the first postoperative day compared to the oral~     formulation.~   "
114601|NCT02067429|"~     This study will compare toric intra-ocular lens (IOL) with limbal relaxing incisions (LRI) in~     correcting astigmatism in patient undergoing standard cataract surgery.~      Astigmatism is unequal curvature of the eye; the eye is oval rather than spherical.~     Uncorrected astigmatism of greater than approximately 0.75 diopters (D) can cause visual~     blurring, ghosting of images or halos. Over 20% of patients undergoing cataract surgery have~     astigmatism which is likely to have been corrected by spectacles.~      Cataract surgery involves the replacement of the natural opacifying crystalline lens with a~     clear artificial plastic intra-ocular lens (IOL). The lens power can be selected to correct~     the patient's glasses prescription. The most widely used IOLs only correct glasses at one~     distance i.e. either near or distance. Residual astigmatism after cataract surgery will need~     glasses for correction which is undesirable for many patients.~      Limbal relaxing incisions (LRI) are circumferential partial thickness cuts to the clear~     window of the eye (cornea) during surgery. These LRIs can correct corneal astigmatism and~     have no additional risk of complications.~      Alternatively, toric IOLs are available which correct astigmatism inside the eye. They have~     been available for routine use in the last few years; technology has markedly improved and~     the lenses have become cheaper.~      Studies have suggested toric IOLs provide better vision after cataract surgery than the~     regular IOLs. Toric IOL are widely used in the private practice and increasingly in the~     National Health Service (NHS). LRIs are cost effective for treating astigmatism however their~     predictability is believed to be lower than toric IOLs. As there are no randomised controlled~     trials comparing the outcomes between LRIs and toric IOLs. This research will address this~     gap in knowledge and accordingly from this research future practice will be able to provide~     treatment to patients with information about the best outcomes.~   "
114602|NCT02067416|"~     Study of the assay, Mammostrat®. to verify its utility as a predictor or outcome tool to~     determine whom would benefit from chemotherapy prior to surgery. Also could be used as a~     clinical marker to identify patients with breast cancer who do not benefit from some~     preoperative chemotherapies.~   "
114603|NCT02067403|"~     Pressure support (PS) is a commonly used mode of ventilation which is triggered based upon~     the patient's own inspiratory efforts. For the most part, pressure support is well tolerated~     by patients. However, because the trigger for pressure support is an inspiratory effort by~     the patient, and because the resulting support is constant, the ventilator response can be~     out of sync with the patient's needs. The problem of patient-ventilator asynchrony has been~     documented to be large in approximately one quarter of patients who require mechanical~     ventilation. Asynchrony is associated with increased or abnormal work of breathing (WOB) and~     prolonged duration of mechanical ventilation. Diagnosing asynchrony at the bedside can be~     challenging. Electrical activation of the diaphragm (Eadi) recording can provide clinicians~     with a more accurate picture of patient-ventilator synchrony and may thus result in decreased~     asynchrony and decreased or normalized work of breathing for the patient. The purpose of this~     physiologic study is to evaluate the role of protocolized pressure support ventilation (based~     upon Eadi) in comparison to standard pressure support ventilation.~   "
114604|NCT02067390|"~     Acute renal injury is a common complication of critical illness. Drug induced renal insult~     compounds the degree of injury in many patients, and a great deal of research has focused on~     prevention of this complication. Traditional biomarkers of renal injury like serum creatinine~     and blood urea nitrogen content fail to consistently predict harm among patients at risk.~     Kidney Injury Molecule 1 (KIM-1) will be studied as a biomarker of renal injury.~   "
114605|NCT02067377|"~     This study will evaluate the use of a medical food, oral serum-derived bovine~     immunoglobulin/protein isolate (SBI), in helping patients with advanced COPD with cachexia (a~     wasting syndrome) improve their nutritional status and gain weight. The medical food is in~     powder form and is mixed with a liquid such as water or orange juice and consumed by~     swallowing. The primary hypothesis is that SBI protein isolate (SBI) will improve the~     nutritional status of cachexic patients with advanced stages of COPD.~   "
114606|NCT02067364|"~     An exploratory Fit & Function study of Continuous Real Time (CRT) ShuntCheck, a~     non-invasive method for monitoring changes in cerebrospinal fluid (CSF) shunt flow in~     hydrocephalus patients. The device will be tested on 10 pediatric patients (at Johns Hopkins~     Hospital) and 10 adult patients (at LifeBridge Health) and results will be used to optimize~     device design.~   "
114678|NCT02066402|"~     This study is aimed to evaluate the efficacy and safety between Tedizolid 200mg daily (intra~     venous) I.V. to oral for 6-day treatment compared with that of Linezolid 600mg twice daily~     I.V. to oral for 10-day treatment Acute Bacterial Skin and skin structure infection~     (ABSSSI).This is a double-blind, randomized, active control, 7-10days treatment for all~     subjects.~   "
114607|NCT02067351|"~     There is evidence that mindfulness-based interventions (MBIs) such as meditation,~     mindfulness-based stress reduction (MBSR) and yoga might improve Quality of Life (QOL) and~     reduce stress in breast cancer survivors. These interventions are becoming increasingly~     popular in cancer survivors. However, little is known about the feasibility and effect of~     MBIs administered during the interval of time of chemotherapy, on QOL and stress. The~     investigators are planning a MBI intervention study developed specifically for breast cancer~     survivors receiving chemotherapy (usually 4-5 months) at the investigators institution, for~     at least 8 sessions combined with at least 8 weeks of home-practice, in 25 women receiving~     chemotherapy for breast cancer.~   "
114608|NCT02067338|"~     The effect of epidural low-dose morphine-soaked microfibrillar collagen sponge in~     postoperative pain control after posterior lumbar spinal surgery: a randomized, double-blind,~     placebo-controlled study~   "
114609|NCT02067325|"~     The purpose of this study is to determine the effect of Thai massage on electromyogram in~     patients with chronic upper back pain associated with myofascial trigger points.~   "
114610|NCT02067312|"~     The purpose of this study is to determine the effect of Thai massage on pain related~     parameters including Pain intensity, 24 hours pain intensity, Pressure pain threshold,~     anxiety, muscle tension, cervical range of motion, pain frequency, patient satisfaction and~     side effect in patients with chronic upper back pain associated with myofascial trigger~     points~   "
114611|NCT02067299|"~     The purpose of the study is to evaluate effect of JNJ-42847922 on sleep latency (latency to~     persistent sleep) in participants with major depressive disorder who are stably treated with~     selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor who suffer~     from insomnia (inability to fall asleep).~   "
114612|NCT02067286|"~     The objective of this study is to evaluate the clinical sensitivity and specificity of the~     Liat™ Influenza A/B & RSV Assay and the Liat™ Influenza A/B Assay when used on the Liat~     Analyzer to detect the presence or absence of Influenza A, Influenza B, and RSV in a~     nasopharyngeal swab specimen as compared to an FDA approved NAAT and culture.~   "
114613|NCT02067273|"~     The purpose of this pilot study is to test the durability of response to Transcranial~     Magnetic Stimulation (TMS) for the symptoms of Complex Regional Pain Syndrome (CRPS). The~     investigators will test various methods of TMS for varying lengths of time in a pilot study~     to investigate what the clinical impact.~   "
114614|NCT02067260|"~     The overall purpose of this clinical investigation is to collect data to support a marketing~     application for over the counter use of the X5 HairLaser with an indication for hair growth.~     The goal of this protocol is to demonstrate that the intended users of the X5 HairLaser can~     safely and effectively perform self-use application by following written instructions.~   "
114615|NCT02067247|"~     The purpose of this study is to compare the accuracy and comparability and secondarily to~     assess the values achieved by measurement of the forearm BMD by DXA and SOS by BeamMed,~     relative to standard DXA evaluations at the FN and LS.~   "
114616|NCT02067234|"~     The goal of the current investigation is to determine whether the inclusion of a~     parent/patient psychoeducational session in initial dermatology appointments with new~     pediatric atopic dermatitis patients affects (a) extent of medical follow-up, (b) patient's~     quality of life, and (c) parenting stress in comparison to treatment as usual for initial~     pediatric dermatology appointments for new pediatric patients with atopic dermatitis.~   "
114617|NCT02067221|"~     The objective of this research is to investigate the surgical outcomes of minimally invasive~     percutaneous nephrolithotomy(MPCNL) and retrograde intrarenal surgery (RIRS)for patients with~     renal stone larger than 1cm.~   "
114618|NCT02067208|"~     Knee osteoarthritis (OA) is commonly treated using laterally wedged insoles. Although these~     insoles typically reduce knee abduction moments (KAM) - a variable associated with knee~     osteoarthritis - and thus are believed to be beneficial for OA management, recent research~     has indicated that in some cases lateral wedge insoles actually increase knee joint loads. In~     such cases, a medial wedge may be more appropriate.~      The purpose of this study is to evaluate the influence of reduced KAMs on pain over 3-months~     for patients with knee OA. It is hypothesized that pain reduction will be directly related to~     KAM reduction.~      Forty-six participants with knee OA will be recruited to participate. Each will undergo~     biomechanical gait analysis to determine the wedge type that most greatly reduces knee~     adduction moments. In addition, each participant will undergo a Dual Energy X-Ray~     Absorptiometry (DXA) scan to quantify adiposity. Finally, participants will complete a series~     of questionnaires to evaluate pain, function, physical activity, footwear comfort and injury~     history. Participants will be randomized into either a wait list control group (no insole) or~     experimental group (medial or lateral wedged insole), and monitored for 3 months.~      Changes to pain, function, comfort and physical activity from baseline to 3 months will be~     assessed within the control and experimental groups. Regression analyses will be conducted on~     the experimental group to determine if a relationship exists between reduced KAMs and reduced~     pain over 3 months. Comparisons will also be made between the control and experimental~     groups.~   "
114619|NCT02067195|"~     To compare the efficacy of 2 different hydration strategies, hydration according to clinical~     guideline and adequate hydration, on contrast-induced nephropathy in patients with STEMI~     undergoing primary PCI to investigate the possible beneficial role of periprocedural adequate~     hydration.~   "
114620|NCT02067182|"~     Oral anticoagulation treatment (OAC) following clinically successful catheter abla-tion of~     atrial fibrillation (AF) is controversial. Recent guidelines recommended con-tinuation of OAC~     in all patients with CHA2DS2VASc score ≥2 even if there is no evidence of recurrent AF (Camm~     JA et al., Eur Heart J 2012). The net clinical ben-efit of OAC after successful ablation in~     these patients remains to some extent un-clear. As OAC bears the risk of bleeding events, the~     ODIn-AF study aims to evalu-ate the positive effect of OAC on the incidence of silent~     cerebral embolic events in patients with a high risk for embolic events, free from AF after~     successful pulmo-nary vein ablation. ODIn-AF aims to determine that continued administration~     of dabigatran is superior in the preven-tion of silent cerebral embolism to discontinuation~     of OAC after 3 months in pa-tients free from symptomatic AF-episodes with a CHA2DS2VASc score~     ≥2 after the first pulmonary vein ablation for paroxysmal AF.~   "
114679|NCT02066389|"~     This is a randomized, double-blind, parallel-group, placebo controlled, multicenter study to~     assess the safety and efficacy of ABT-494 in subjects with active rheumatoid arthritis who~     have failed Methotrexate alone.~   "
114621|NCT02067169|"~     Resistance to antivirals is a growing problem in transplantation.that may concerns up to 5%~     of patients treated for cytomegalovirus (CMV) syndrome or disease in recent per-protocol~     studies. This prevalence vary with the organ transplanted and the degree of viral replication~     and immunosuppression. Less data are available to date from real-life cohorts of patients,~     and there is no systematic survey of resistance in Europe or in the US. Non response to~     treatment concerns a larger group of patients and can result either from emergence of a~     resistant strain (virological resistance), from inadequate dosage of antivirals, or a high~     degree of immunosuppression, with a poor CMV immune response. The respective clinical impact~     of virological resistance and clinical resistance (of pharmacological or immunological~     origin) on graft outcome and long-term survival of patients has never been assessed. High~     viral loads and persistent replication associated to prolonged exposure to antivirals are~     known to favor the emergence of resistant strains. Though epidemiology of resistant strains,~     role of multiple infections, impact of various mutations on degree of resistance to~     antivirals and outcome remains to be further studied. Most studies are per-protocol studies~     or short-term studies conducted on limited populations. There are no data in real-life of~     transplanted patients at the era of enlarged prophylaxis except those from the French survey~     for cytomegalovirus resistance cohort opened at the end of 2006. From the first data~     collected on 346 patients we shown a 10,6% prevalence of non-response to therapy with 5,2% of~     virological resistance (6,1% incidence at one year on 214 patients) with a trend to poorer~     outcome in case of virological resistance and to the absence of impact of prophylaxis versus~     preemptive therapy, though larger populations and prolonged follow-up are requested to~     fulfill all objectives.~      We therefore aim to constitute a prolonged survey cohort for CMV resistance with a large~     number of patients and a prolonged follow-up, to gather data on resistance to antivirals in~     real-life of transplant patients in an organized data bank, This cohort is in the continuum~     of our previous cohort started in 2006, granted by the Hospital Clinical Research Program~     Interregional (PHRC), with the same major objectives and prolonged follow-up of patients.~   "
114622|NCT02067156|"~     Glioblastoma (GBM) comprises about 16% of all malignancies of the nervous system and over 50%~     of all gliomas. Standard of care for newly-diagnosed GBM is a combination of surgical~     debulking followed by concurrent radiotherapy and chemotherapy with temozolomide. Efforts to~     improve second-line therapy in GBM have met with only marginal success and there is a large~     unmet medical need for new therapies. G-202 (mipsagargin) is an example of prodrug~     chemotherapy. It is activated by Prostate Specific Membrane Antigen (PSMA), which is~     expressed by some cancer cells and in the blood vessels of most solid tumors, including GBM,~     but not by normal cells or blood vessels in normal tissue. It is believed that activation of~     the prodrug G-202 will allow the drug to kill cancer cells. This study will evaluate the~     activity, safety and CNS exposure of G-202 in patients with recurrent or progressive GMB~     receiving G-202 by intravenous infusion on three consecutive days of a 28-day cycle. Funding~     Source - FDA OOPD~   "
114623|NCT02067143|"~     This study will be conducted in different centres and will study adult patients with~     Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL). The study~     treatment will include a induction/consolidation therapy incorporating pegylated Asparaginase~     (Peg-ASP) and lineage-targeted high-dose methotrexate plus other antileukemic drugs, for the~     achievement of an early negative minimal residual disease (MRD) status. The MRD study~     supports a risk/MRD-oriented final consolidation phase.~   "
114624|NCT02067130|"~     In patients with hereditary anemias (e.g. thalassemias), defective red blood cells are~     produced due to an error in the genes, or DNA, that provide the instructions for their~     synthesis. As a result, hereditary anemias are characterized by chronically low hemoglobin,~     which is contained inside red blood cells and carries oxygen throughout the body. In more~     severe cases, patients are dependent on frequent blood transfusions to replenish the~     hemoglobin.~      The body has limited ability to get rid of excess iron. However, with repeated blood~     transfusions, the iron level in the body builds up because the red blood cells contain iron~     as heme. Over time, the high level of iron accumulates in organs such as the heart, liver,~     and pancreas causing heart problems, liver failure, and diabetes. As a result, patients who~     receive multiple blood transfusions need to be monitored for iron overload, and be started on~     medical therapy in a timely fashion to prevent organ damage.~      Liver is usually the first and the most affected organ by iron accumulation, so knowledge of~     its iron concentration provides estimate of total body iron load. Liver biopsy is the gold~     standard in measuring the iron concentration in the liver, but it is invasive and cannot be~     performed on routine basis. MRI is another option that can assess liver iron concentration~     non-invasively, and is currently recommended for monitoring iron load on a yearly basis.~     However, MRI has a high cost and is not easily accessible in Canada. The investigators aim to~     determine if transient elastography (Fibroscan), which is a form of ultrasound that measures~     liver stiffness, can accurately assess liver iron concentration.~      Hypothesis:~      Fibroscan reading correlates with MRI and serum ferritin in estimating hepatic iron~     concentration.~   "
114625|NCT02067117|"~     This study is aimed to confirm the lot-to-lot consistency of 3 consecutive batches of 'GC~     FLU® Pre-filled Syringe Injection' and 'GC FLU® Injection' in the lot-to-lot~   "
114626|NCT02067104|"~     This study is a single site double blinded Phase II study to evaluate the chemopreventative~     effectiveness of vismodegib in the treatment of subjects at high risk for developing basal~     cell carcinomas (BCC).~   "
114627|NCT02067091|"~     Patients presenting with acute ST elevation myocardial infarct urgently need~     revascularization. Standard of care is establishing bloodflow through the coronary vessels~     using thrombus aspiration catheter, and securing the result by using a metallic drug eluting~     stent. New kinds of non-metallic bioresorbable stents are now available. They have however~     challenges in structural strength.~      The investigators want to compare the new bioresorbable scaffold with traditional metallic~     stents in this setting in a prospective, randomized, non-blinded, multicenter study in 120~     patients. The investigators will use an imaging technique, optical coherence tomography, to~     evaluate the results after 12 months.~      The investigators also want to see if modern multislice computed tomography can give useful~     information in the follow-up of stented coronary arteries after 12 and 24 months.~   "
114649|NCT02066792|"~     The purpose of this study is to examine the efficacy of 50 mg of d-cycloserine in comparison~     to placebo (a pill containing no medication) for improving the effectiveness of~     cognitive-behavioral therapy (CBT) in reducing symptoms associated with social anxiety~     disorder. In addition, the study will examine whether the effectiveness of d-cycloserine~     depends on the timing of the pill administration (i.e., 1- hour before the session or~     immediately after the session) as well as the success of the CBT therapy sessions. The~     investigators hypothesize that the tailored post-session DCS administration condition will~     outperform the other conditions (pre-session DCS, placebo, and non-tailored post-session~     DCS). This will be evidenced by short- and long-term improvements in social anxiety severity.~   "
114650|NCT02066766|"~     This study is conducted in Asia. The aim of this non-interventional study is to evaluate the~     current status of diabetes management, control, and complications in diabetic subjects in~     Vietnam.~   "
114628|NCT02067078|"~     Purpose:~      The purpose of this study is to evaluate the postoperative analgesic effect of a combined~     Saphenous nerve block and Obturator nerve block with local infiltration analgesia in the~     tissue around the knee after surgery with knee replacement. In the combined nerve blocks we~     use a mixture of Bupivacaine, Adrenaline, Clonidine and Dexamethasone (protracted mixture)~     and the local infiltration consist of Ropivacaine, Adrenaline and Toradol. Our hypothesis is~     that the combined nerve blocks with protracted mixture prolongs block duration, reduces pain~     and reduces the need for morphine and thus reduce side effects such as nausea, vomiting and~     lethargy compared to the current treatment with local infiltration analgesia.~      Background:~      Nerve blocks as analgesic treatment after orthopedic surgery is a recognized and proven~     procedure. The nerve blocks have the disadvantage that not only do they anesthetize the~     sensory nerve fibers but also the nerve fibers to the muscles of the leg. The Saphenous nerve~     block causes only stunning of sensory nerves to the knee region. The Obturator nerve block~     causes both stunning of the sensory nerves to the knee region and the thighs inward leading~     muscles, and does not affect the patient's mobilization capacity.~      Both blocks are known to be a good addition to the analgesic treatment. Bupivacaine is a~     well-known local anesthetic. Adrenaline, Clonidine and Dexamethasone have also been used in~     other studies, in addition to the local anesthetic agent, and has been shown to prolong the~     effect of the nerve block. Saphenous and Obturator nerve block with all four drugs~     Bupivacaine, Adrenaline, Clonidine and Dexamethasone has not been systematically investigated~     in knee replacement surgery, and it is not known whether this method will provide better pain~     treatment.~      Method~      The patient can receive one of three treatments, determined randomly:~        -  A. Saphenous and Obturator nerve block with active anesthetics (Bupivacaine, Adrenaline,~          Clonidine, Dexamethasone) and local block around the knee joint with placebo medicine~          (normal saline).~        -  B. Saphenous block with active anesthetics and both Obturator nerve block and local~          block around the knee joint with placebo medicine (normal saline).~        -  C. Both block with placebo medicine (normal saline) and local block around the knee~          joint with effective local anesthetic.~      Neither patient, investigator or staff around the patient will have knowledge of which~     treatment the patient has received.~      The blocks will be injected before the operation and local infiltration around the knee joint~     will be given by the surgeon during the operation.~   "
114629|NCT02067065|"~     Propofol is the preferred sedation for colonoscopy. There is debate on the safety of the~     administration of propofol by non-anesthesiologists, despite moderate quality evidence that~     support its' use.~      There is only one small trial of a direct comparison of propofol sedation by~     anesthesiologists versus non-anesthesiologists.~      Our aim is to compare the incidence of sedation related adverse events, the procedural~     quality indicators, times (onset, recovery, discharge) and patient satisfaction between~     non-anesthesiologist administered propofol sedation (NAAP) sedation and anesthesiologist~     propofol sedation.~      A randomized clinical trial with the incidence of sedation related minor adverse events as~     primary endpoint will be conducted. Secondary endpoints include procedure quality indicators,~     propofol dosage and patient satisfaction.~      A sample size of 330 subjects (2 arms of 165 patients) will be needed in order to obtain 90%~     power and a 5% significance level to exclude a 15% difference (15 - 30%) in adverse events~     incidence, estimated from our pilot experience. The sample size was adjusted for a 2%~     cross-over rate.~      Informed and consenting patients undergoing colonoscopy examinations will be randomly~     assigned to one of two arms. One group will be sedated by an anesthesiologist according to a~     protocol of propofol mono-sedation. The other group will be sedated with propofol boluses,~     according to the European Society of Gastrointestinal Endoscopy (ESGE) NAAP guideline, with a~     3-man team consisting of one endoscopist, one endoscopy nurse and a sedation nurse, trained~     in NAAP and exclusively dedicated to sedation and patient monitoring.~   "
114630|NCT02067052|"~     Vulvar cancer is a rare disease that is treated with surgery, radiation and chemotherapy.~     When tumors are large (greater than 4 cm) or compromise the urethra (urine canal) and the~     anus, or when it is in the groin lymph nodes, surgery alone is not always able to be~     performed. In this circumstance, is necessary to add radiotherapy, chemotherapy or both .~      So far it is not known the best sequence of treatment: surgery, chemotherapy or radiotherapy.~     The radical surgeries usually need long recovery term both in the region of the vulva and in~     the region of the groin lymph nodes. When it is performed, convalescence can delay other~     treatments, like radiotherapy and chemotherapy. On the other hand, the use of radiotherapy~     and chemotherapy as a first step treatment can result in a complete elimination of the~     disease in at least 30% of the cases or substantial reduction of its size, allowing less~     extensive surgery.~      Investigators intend to use surgery, chemotherapy and radiotherapy in the treatment of vulvar~     cancer, but in a sequence that has not been studied, in order to increase benefits of these~     treatments, and reduce morbidity.~      This study will be offered to patients who have disease of the vulva less than 4 cm (sentinel~     lymph node), or greater than 4 cm, or illness that compromises urethra and anus, or patients~     with disease in groin lymph nodes (glands).~        1. On the eve of the surgery, investigators will inject dextran-70 labeled with~          technetium-99 m. Only patients with tumors smaller than 4 cm will do this procedure.~        2. On the day of the surgery, the groin lymph nodes will be removed from the inguinal~          (groin) only. If lymph nodes are disease positive, the vulvectomy will not be performed~          at this time. Patients will be treated with radiation therapy with concomitant~          chemotherapy for approximately six weeks.~        3. At the end of treatment with chemotherapy and radiotherapy, investigators will perform a~          surgery to remove the remaining tumor in the vulva.~   "
114631|NCT02067039|"~     This study seeks to determine the public health impact of providing rapid HIV test kits to~     men who have sex with men (MSM) so they may test themselves at their convenience. The study~     will determine if men who receive the rapid HIV test kits report HIV testing at least three~     times per year. This study will be conducted in four consecutive parts. The first three parts~     are formative in nature to guide the development and implementation of Part 4 of the study.~     The research study will use two different types of rapid HIV tests. The OraQuick® In-Home HIV~     Test for oral fluid (FDA approved for home use) and Sure Check® HIV 1/2 Assay, currently~     FDA-approved for professional use and distributed in the U.S. as Clearview® Complete HIV-1/2~     Rapid Test. An Investigational Device Exemption will be obtained from the FDA to allow the~     contractor to supply the Sure Check® HIV 1/2 Assay to study participants since it is not~     approved for home use.~   "
114632|NCT02067026|"~     Study hypothesis Aleurone-rich food supplementation modifies cardiovascular and metabolic~     risk profiles and gut microbiota in subjects with high BMI~      Primary objectives of the trial are to evaluate whether wheat Aleurone-rich food~     supplementation modifies (1) fasting homocysteine levels; (2) human biofluid primary~     metabolites; (3) human biofluid secondary (microbiota-derived) metabolites; (4) fecal bile~     acid and fecal sterol concentrations.~      Secondary objectives are to evaluate whether wheat Aleurone-rich food supplementation~     modifies (1) fecal microbiota, (2) plasma and urine MS based metabolite profiling; (3) total~     cholesterol, triglycerides, LDL- and HDL-cholesterol levels; (4) serum glucose and insulin~     levels; (5) anthropometric indices; (6) urinary isoprostane levels; (7) markers of intestinal~     permeability in plasma; (8) inflammation~      Study Design Placebo-controlled, randomized, double-blind parallel trial Criteria for~     Enrollment Inclusion criteria: Aged 18-65 years; BMI >27 kg/m^2. Good General health.~      Exclusion criteria: Fasting blood glucose >300 mg/dl; triglycerides >500 mg/dl; uncontrolled~     hypertension (blood pressure [BP] >160/100 mm Hg under antihypertensive therapy); any long~     term medical therapy; food intolerances; alcohol intake >5 drinks per day or use of narcotic~     substances; use of dietary supplements, pro or pre- biotics; special diet; pregnancy, tobacco~     smoking.~      Methodology After a run-in phase of two weeks, participants will be randomized to receive~     supplementation with either wheat Aleurone-rich food (27 g Aleurone/day) or placebo for 4~     weeks in a double-blind manner. Clinical visit, clinical tests, and blood drawing will be~     performed after an overnight fasting at the start of the run-in phase (visit T-1) at U.O.S.~     di Dietetica e Nutrizione Clinica, St Chiara, Trento. Clinical tests, blood drawing, and~     stool and urine collection will be performed during visits at the beginning and end of each~     treatment period (T0 and T1) at U.O.S. di Dietetica e Nutrizione Clinica, St chiara, Trento.~     A 4 day-food diary record will be collected before visits T0 and T1.~      Efficacy Assessments Arterial BP; BMI; ratio of waist to hip circumference; food~     questionnaires; blood sample analysis (total cholesterol, triglycerides, HDL and LDL~     cholesterol, serum glucose and insulin, C-RP, plasma LPS, LPS specific IgG, CD14, LPS-binding~     protein); urinary isoprostane; urinary and plasma metabolite profiling; fecal microbiota~     analysis.~      Safety Assessments. Adverse events.~      Statistical analyses. Post-intervention data will be compared by ANOVA using the General~     Linear Model with baseline as a covariate. Data with a skewed distribution will be log~     transformed before analyses. Simple and multiple linear regression will be used to determine~     relationships between variables and independent t-tests performed to evaluate differences in~     reported compliance between groups. Results will be expressed as mean +/- SEM and differences~     will be considered significant at P < 0.05..~      Duration of Dosing. Subjects will make three visits during the study (start of run-in phase -~     visit T-1-, beginning - visit T0, week 2 - and end of treatment period - visit T1, week 6).~     Duration of the treatment period is four weeks; a daily Aleurone consumption of 27 g is~     targeted.~   "
114633|NCT02067013|"~     Clinical Retina research studies often collect aqueous samples in hopes of estimating levels~     of drug or cytokines in the vitreous. Little is known about how well vitreous and aqueous~     correlate. This study will collect vitreous and aqueous samples at the same time to evaluate~     and compare drug and cytokine levels.~      The overall objective of this study is to evaluate the molecular concentration of growth~     factors, cytokines and chemokines in human aqueous humor and vitreous samples collected from~     individuals undergoing pars plana vitrectomy for tractional retinal detachment secondary to~     proliferative diabetic retinopathy, exudative or tractional retinal detachment secondary to~     macular degeneration, macular hole or neovascular glaucoma.~   "
114634|NCT02067000|"~     Validation of the patient perception questionnaire relating to CPAP use~   "
114635|NCT02066987|"~     the present study had two main aims. First, due to the current underconsumption of dental~     brush adolescents, the investigators should apply a volitional intervention to increase oral~     health behvaiour in adolescents. Second, the investigators aim to compare the effectiveness~     of action planning intervention and implementation intention will improve oral health~     behavior in adolescents.~   "
114651|NCT02066753|"~     This PhD study is a sub study in a randomized clinical controlled multicenter trial named~     TTH48 (ClinicalTrials.gov Identifier: NCT01689077).~      The TTH48 trial examines prolonged mild therapeutic hypothermia (MTH) at 32-34°C in 24~     versus 48 hours with the primary outcome Cerebral Performance Category after 6 month in~     comatose out-of-hospital cardiac arrest patients.~      THE OVERALL AIM OF THIS PhD STUDY IS TO INVESTIGATE THE CARDIAC FUNCTION AND THE HEMODYNAMICS~     BY BIOCHEMICAL CARDIAC MARKERS, ECHOCARDIOGRAPHY, BY ANALYZING THE USAGE OF~     INOTROPES/VASOPRESSORS AND BY ANALYZING ECG DATA FOR ARRHYTHMIAS IN THE 24 VERSUS 48 HOURS~     MTH GROUPS.~   "
114636|NCT02066974|"~     Hepatocellular carcinoma (HCC) is a common cause of cancer mortality in Asia. Most patients~     were presented with advanced disease. Percutaneous ethanol injection, radiofrequency~     ablation, and transcatheter arterial chemoembolization (TACE) are not considered as a~     curative treatment and have achieved very limited success in eradicating large HCC or tumors~     causing portal vein thrombosis. With the development of novel radiotherapy (RT) technique, RT~     can be safely given to patients with larger tumor or portal vein thrombosis. However, RT~     could achieve a tumor response rate of approximately 50 %. Currently, there was a paucity of~     studies regarding a quantitative biomarker to predict tumor response or forecast the outcome~     in advance. To optimize the therapeutic index, there is a need to seek effective biomarkers~     for personal medicine because pretreatment AFP is not always useful as a surrogate marker in~     some of the patients.~      The present study is to investigate whether circulating tumor cell genome in peripheral blood~     can be used to predict RT response in HCC. We will use the blood sample from patients with~     locally advanced HCC receiving RT. By using next generation sequencing, We are going to~     explore the quantity and quality changes of DNAs and RNAs in the patient's serum or plasma.~     By this way, genomic expression in peripheral blood may play a key role in determining the~     optimal therapeutic strategies for HCC patients by predicting tumor response to RT.~   "
114637|NCT02066961|"~     The purpose of this study is to describe patterns in disease management and to describe~     clinical outcomes, as well as to identify factors influencing physician treatment decisions~     including reason(s) for treatment choices and trigger(s) for treatment changes and to~     document healthcare resource utilization used to manage treatment-related complications.~   "
114638|NCT02066948|"~     About two-thirds of adults in the United States are overweight or obese with likely adverse~     health consequences. A Moderate weight loss by dieting and exercise is recommended to improve~     health. We are interested to know whether eating dietary protein at different times of the~     day influences changes in body composition, muscle and indices of health. The purpose of this~     study is to examine the effects of within-day patterning of dietary protein intake (even vs.~     skewed) on energy-restriction and resistance training-induced changes in body composition,~     muscle size, appetite, and clinical health (including blood glucose and blood pressure).~   "
114639|NCT02066935|"~     The purpose of this study is identify the prevalence of non-adherence to immunosuppressives~     in Brazilian renal transplant recipients, identify the factors related to non-adherence in~     the studied population and identify the prevalence of non-adherence in the different regions~     of the country.~   "
114640|NCT02066922|"~     The purpose of this study is to compare the change from baseline in central corneal curvature~     at one week, between 2 silicone hydrogel lenses, in higher myopic subjects.~   "
114641|NCT02066909|"~     This study is designed to evaluate the safety and plasma concentrations of PF-06649751 in~     healthy volunteers following one or two times daily oral dosing of PF-06649751 for 14 days~     (Cohorts 1 - 4), 21 days (Cohort 5), or 28 days (Cohorts 6 - 8). Cohort 9 will dose Japanese~     healthy volunteers in a manner identical to Cohort 4 and is intended to bridge the~     safety/tolerability and PK data from the Western and Japanese populations.~   "
114642|NCT02066896|"~     This study was designed to test the efficacy and safety of low laser therapy to treat the~     xerostomia of patients with primary Sjogren's Syndrome.~   "
114643|NCT02066870|"~     The NSCLC patients who experienced good clinical responses to an EGFR-TKI will inevitably~     develop acquired resistance. A great deal of research are focusing on this issue. Arsenic~     trioxide showed efficacy and safety in acute promyelocytic leukemia, multiple myeloma and~     other solid tumors. Moreover, preclinical studies showed arsenic trioxide can reduce the~     resistance of tumor cells to chemotherapy and TKIs.~   "
114644|NCT02066857|"~     The purpose of this prospective randomized study is to add to the body of knowledge on the~     treatment of minimally displaced distal radius fractures in patients over 60 years of age.~     The investigators believe that treating minimally displaced distal radius fractures in people~     over 60 with a removable splint and early range of motion will provide greater patient~     satisfaction, fewer complications, and earlier functional returns to pre-injury for these~     patients compared to those treated with a short arm cast which immobilizes the limb for at~     least four weeks, and has been shown to lead to longer recovery and possible residual~     stiffness. The investigators hope to provide sufficient evidence in directing treatment that~     will give the most efficacious and the most satisfactory return of prior function to~     patients. Since distal radius fractures in the elderly are common because of poorer bone~     quality, the elderly proportion of the population is increasing, and controlling health costs~     is of current concern, answering the question of which treatment produces the best results~     for all these concerns is of increasing importance now.~   "
114645|NCT02066844|"~     The purpose of this randomized, parallel-group, single-blinded, single center, Phase II study~     is to collect data to compare the comfort and patient satisfaction of a hip injection~     delivered via the Navigator compared to a standard needle injection. In addition, delivery~     preparation will be compared between a Navigator injection and a standard hip injection. The~     data collected from this pilot study will serve as the basis to design a larger multi-center~     study.~   "
114646|NCT02066831|"~     The purpose of the study is to compare the effect of telemedical coaching versus telemedical~     control on HbA1c, weight, BMI, blood pressure, blood lipids, medication, nutrition, physical~     activity and quality of life in type 2 diabetes patients with poor glycaemic control.~   "
114647|NCT02066818|"~     Local anesthesia used for incision and drainage of abscesses is known to be painful.~      We studied the analgesia provided by a lidocaine/tetracaine patch compared to injectable~     lidocaine during incision and drainage (I&D) of skin abscesses.~      Local injection of lidocaine provided similar analgesia compared to the lidocaine/tetracaine~     patch during I&D of skin abscesses in the Emergency Department. Pain at presentation and~     following the procedure was similar in both groups.~   "
114648|NCT02066805|"~     This study aims to evaluate off-label XGEVA use in Denmark using data linked from registries~     and other sources in Northern Jutland Region and Copenhagen. This will allow for accurate~     assessment of prescriptions and diagnoses, especially those related to cancer patients during~     the first year post the initial market availability of XGEVA.~   "
114652|NCT02066740|"~     The purpose of this study is to collect acute confirmatory data to evaluate technical success~     and acute safety of the EverFlex™ self-expanding peripheral stent with Entrust™ delivery~     system.~   "
114654|NCT02066714|"~     Hand Foot and Mouth Disease (HFMD) is a common infectious disease in childhood. Several~     enteroviruses are associated with the disease. However, since 1997, large outbreaks of HFMD~     in Taiwan, Malaysia and Vietnam have seen unusual neurological complications such as~     brainstem encephalitis with rare fatal outcomes. The pathogen associated with this severe~     disease is Enterovirus 71.~      In 2011, Vietnam had a large outbreak of Hand Foot and mouth disease resulting in 110,000~     cases and 164 deaths. HFMD affects children during their early years of child development,~     but there is limited information on what the potential long-term consequences are. Small~     studies have suggested language and cognitive difficulties in more severe disease but this~     has not been evaluated in a large cohort.~      Internationally recognized and standardized assessment tools are not available for early~     childhood in Vietnam. This project will translate and adapt the Bayley Scales of Toddler and~     Infant Development 3rd edition (Bayley III) and Movement ABC, 2nd edition (MABC) into~     Vietnamese as outcome measures.~      This study will evaluate whether there are neurodevelopment difficulties following severe~     HFMD. The study design is a prospective observational cohort study. Hospitalised children~     with a clinical diagnosis of HFMD will be eligible to enroll. Written parental consent will~     be required. Participants enrolled will be assessed 3 times over 18 months from discharge~     from hospital into the study. Since there is no standardization of Bayley III or MABC for~     Vietnam, a healthy cohort, age and sex matched to the least severe HFMD participants will be~     recruited. This healthy cohort will follow the same assessment program over 18 months. A~     total of 350 HFMD participants and 150 healthy children (matched to the least severe HFMD~     participants) will be recruited.~   "
114655|NCT02066701|"~     This study is to identify potential markers from esophageal biopsies and brush cytology for~     feasibility of use in stool specimens for detection of Barretts Esophagus.~   "
114656|NCT02066688|"~     Folic acid (FA) and its derivatives (folate) which play a role in nucleotide synthesis and~     methylation reactions as well as calcium and vitamin D are assumed to be effective in the~     prevention of colorectal polyps and Colorectal cancer (CRC). The aim of this study is to~     investigate the roles of FA as well as calcium and vitamin D in the prevention of CRC.~   "
114657|NCT02066675|"~     Phase II, non-randomized, two-stage study according to Bryant & Day The study enroll patients~     with Metastatic and locally advanced soft tissue sarcoma unfit to receive standard~     chemotherapy (doxorubicin/epirubicin and/or ifosfamide)~   "
114658|NCT02066662|"~     The following trial hypothesis will be proved: In patients with atrial fibrillation and/ or~     pulmonary embolism standard anticoagulant treatment with coumadin/phenprocoumon is associated~     with accelerated coronary or valvular calcification as assessed by cardiac computed~     tomography compared to the new anticoagulant therapy with rivaroxaban.~   "
114659|NCT02066649|"~     Subjects will be those individuals greater than 18 years of age with a diagnosis of cirrhosis~     undergoing screening for esophageal varices. Eligible subjects will have a diagnosis of~     cirrhosis and esophageal varices (graded as medium or large) with no prior history of~     variceal bleeding. The diagnosis of cirrhosis will be based on clinical, radiologic, and/or~     laboratory data. Patients will be randomly assigned using electronic medical records to one~     of three treatment arms after screening esophagogastroduodenoscopy (EGD) has been performed~     and large varices are identified. Primary outcome of the study will be the incidence of~     variceal bleeding in patients receiving one of the following therapies for primary~     prophylaxis of variceal bleeding: carvedilol, variceal band ligation (VBL), or both~     carvedilol and VBL.~   "
114660|NCT02066636|"~     The purpose of this study is to estimate the incidence and characterize the outcome of high~     grade, select adverse events in subjects with advanced or metastatic NSCLC treated with~     Nivolumab.~   "
114661|NCT02066623|"~     The German-Austrian ABSORB Register shall provide an analysis of acute and long-term safety~     as well as therapy outcomes of the ABSORB (trade mark) bioresorbable vascular scaffold system~     in patients suffering from coronary artery disease.~   "
114662|NCT02066610|"~     The objectives of the study were to assess the serum selenium, zinc, and copper status and~     plasma and white blood cell antioxidant enzyme activities of low birth weight infants~     receiving selenium supplemented and non-selenium supplemented parenteral nutrition from~     initiation of parenteral nutrition until discontinuation of preterm formula or hospital~     discharge.~   "
114663|NCT02066597|"~     Venous thromboembolism (VTE) is a common condition that occurs when a clot develops in one of~     your veins. It affects 5% of the population and is the third most common circulatory~     condition after heart attack and stroke. People who experience a clot in their vein can have~     significant long term problems with swelling and discomfort. The investigators call this post~     thrombotic syndrome (PTS). They can also be at increased risk of having another clot occur.~     People who have ilio-femoral clots are more likely to have more severe leg swelling and pain~     than those who have clots in smaller veins. They are also more likely to have problems~     returning to their normal daily routines and may need more hospital visits.~      The current standard of care involves treating patients with anticoagulants (blood thinners)~     because it has a low risk of bleeding risk and is inexpensive. Blood thinners prevent the~     clot from growing bigger while your own body dissolves the clot over time.~      The type of clot you have is the most severe form of DVT. Some experts advise early removal~     of the clot - resulting in symptom relief sooner and possibly reducing the risk of PTS. This~     is in addition to the standard treatment with blood thinners.~      There are currently two options for physically removing these clots. One method involves~     placing an intravenous catheter into your leg and injecting medication directly where the~     clot is situated. This dissolves the clot. This method is called Catheter Directed~     Thrombolysis (CDT). The second method, Percutaneous Mechanical Thrombectomy (PMT), involves~     placing an intravenous catheter into your leg and breaking down the clot mechanically and~     suctioning it out of the vein - creating good blood flow again to your leg. Both methods~     require injection of contrast dye and a special x-ray machine to see where the clot is and~     ensure that the entire clot is removed.~      CDT is very expensive and has an increased risk of major bleeding. PMT is much less expensive~     and has a lower risk of bleeding. The doctors at The Ottawa Hospital do not typically~     recommend CDT, nor do we commonly perform PMT for this patient population here.~      The investigators would like to enroll 26 participants with ilio-femoral DVTs and perform PMT~     to see if they can achieve better outcomes than for those who have just had our routine~     treatment of blood thinners. The investigators are only conducting this study here at The~     Ottawa Hospital, General Campus. They will follow the progress of participants for 6 months.~     The device the investigators are using (Angiojet Ultra Thrombectomy System) is already~     approved by Health Canada for this procedure.~   "
114664|NCT02066584|"~     The importance of glucose in culture media on fertilization and embryo development is still~     controversial. Although it has been reported that glucose is essential for fertilization~     process and biosynthesis of membrane lipid and nucleic acids, comparatively high levels of~     glucose in culture media may cause developmental arrest of cleavage stage embryos. The aim of~     this retrospective study is to examine whether exposure of sibling oocytes to different~     concentrations of glucose in culture media has any further effect on IVF outcome.~   "
132457|NCT01833559|"~     The study is to investigate the impact of blood glucose management at the first trimester of~     pregnant women with gestational diabetes on the maternal and fetal outcomes and metabolic~     disorder.~   "
114665|NCT02066571|"~     Since droxidopa has been approved in Japan for treating freezing of gait in Parkinson's~     disease patients, this is to confirm and further investigate the safety and efficacy using a~     similar dose. The possible beneficial effects on cognition in mildly cognitively impaired~     Parkinson's disease patients will also be tested, since this problem in Parkinson's disease~     may be associated with decreased brain synthesis of norepinephrine (a neurotransmitter~     associated with multiple brain functions).~      During this 11 week study, droxidopa will be slowly titrated up to 600 mg daily. Walking and~     freezing of gait will be evaluated and rated. Cognitive functions will be evaluated by a~     computer-based program.~   "
114666|NCT02066558|"~     In this study the investigators will research the hypothesis that the gas carbon monoxide~     induces headache and increases the blood flow velocity in the middle cerebral artery.~   "
114667|NCT02066545|"~     The primary objective of this study is to evaluate the safety and efficacy of once-daily~     topical application of CLS001 1%, 1.75% and 2.5% topical gel compared to vehicle topical gel~     in subjects with inflammatory acne vulgaris~   "
114668|NCT02066532|"~     The purpose of this study is to examine the safety and efficacy of Ruxolitinib in combination~     with Trastuzumab in treatment of HER2 positive metastatic breast cancer. Ruxolitinib (Jakafi)~     is an Food and Drug Administration (FDA) approved treatment for myelofibrosis (a disease of~     the bone marrow), but its safety and efficacy in breast cancer patients is not known.~     Trastuzumab (Herceptin) is an FDA-approved treatment for HER2 positive breast cancer. The~     safety and efficacy of both treatments given in combination is not known. It is hypothesized~     that Ruxolitinib in combination with Trastuzumab will demonstrate efficacy in treating~     Metastatic HER2 Positive Breast Cancer subjects, and will have a tolerable safety profile in~     this patient population.~   "
114669|NCT02066519|"~     The purpose of this study is to demonstrate that a 3 months physical exercise programme~     improves the Quality of Life of patients with generalized Myasthenia Gravis (MG) stabilized~     since at least 6 months under prednisone and/or azathioprine.~   "
114670|NCT02066506|"~     the first purpose of the study is to determine the adaptative mechanisms of right ventricle~     (RV) to systemic afterload, and the mechanisms of RV failure, in patients with congenital~     heart disease and subaortic RV, using cardiac magnetic resonance imaging (CMR).The mechanisms~     are evaluated by measures of RV remodelling and RV wall stress using CMR. Second objectives~     are to evaluate these mechanisms using echography, arterial properties study and~     neurohormonal levels~   "
114671|NCT02066493|"~     The purpose of this study is to generate detailed insight into which therapies of giant~     intracranial aneurysms are being conducted, to document the natural history and the outcome~     of treatment over 5 years after inclusion into the Registry and to follow imaging data of~     giant aneurysms over years after diagnosis.~   "
114672|NCT02066480|"~     Osteoporosis is a disease characterized by skeletal fragility due to decreased bone mass and~     deterioration of bone microarchitecture , leading to increased fracture risk for low trauma,~     such as spinal fractures or femoral neck .~      It is estimated that 3 million people are living in France , particularly women , with an~     incidence that increases with age .~      This disease is a major public health issue in terms of morbidity and mortality , costs and~     risk of recurrence (after a first fracture episode) , including risk factors are identified.~      However, although bone densitometry is a reliable diagnostic tool and preventive treatments~     are at our disposal, screening for osteoporosis is still insufficient .~      The objective of our study is to improve the detection of osteoporosis in Hospital~     Departmental Vendee , using a simple questionnaire seeking risk factors followed by bone~     densitometry or if risk factors are found. Based on the results , the patient will be sent in~     rheumatology consultation for implementation of treatment if necessary .~      Therefore included women hospitalized in medical services , gynecology, surgery and~     orthopedics Hospital Departmental Vendee , aged 50 to 80 years. Will not be included women~     who could answer a simple questionnaire and those previously treated for osteoporosis or have~     already received a bone density there is less than 3 years old .~   "
114673|NCT02066467|"~     The objective of this study is to collect clinical data on safety and performance of ACUITY~     X4® leads when used in a standard clinical setting.~      It is a prospective, non-randomized, observational multicenter study evaluating standard of~     care.~      For Post Market Clinical Follow up (PMCF) purposes the 3 month implant success rate, adverse~     events and basic parameters of the lead will be assessed. The cohort of subjects included in~     this evaluation will be the first 200 subjects which are indicated for PMCF in Rally X4 to~     receive an ACUITY X4® lead implant.~      Study endpoints:~      Phrenic Nerve Stimulation (PNS) related CFR through 6 months post-implant (Defined as: rate~     of freedom from loss of function or operative system revision due to unacceptable PNS~     threshold) Lead-related Complication-Free Rate (CFR) from Implant through 3 months~     post-implant.~   "
114674|NCT02066454|"~     To evaluate:~        -  the incidence of venous thromboembolic event (VTE)~        -  the incidence of hemorrhagic complications, In a population of patients with myeloma who~          are treated with IMiDs and require thromboprophylaxis for 6 months, using an oral~          anti-Xa anticoagulant, Apixaban, in a preventive scheme, 2.5 mg x2/day~   "
114675|NCT02066441|"~     The purpose of this study is to compare vitamin D deficient and vitamin D sufficient elderly~     individuals and examine the effect of a vitamin D dietary supplement on serum vitamin D~     level, bone formation, resorption, and mineral density, flexibility, balance, general~     inflammation,and quality of life. Enhancing nutritional status is necessary to prevent the~     continued proliferation of chronic diseases, e.g., bone disease and other chronic disorders~     thought to now be related to low levels of vitamin D, which are some of the leading disablers~     and killers of Americans. Americans also have difficulties with compliance to prescription~     medications due to their toxicity and side effects. This study aims to learn more about how a~     vitamin D nutritional supplement may improve nutritional status and enable the body to~     normalize system functioning,which may improve the quality of life for people with vitamin D~     deficiency. The results of this research will be used to determine if vitamin D is beneficial~     for overall health among elderly individuals.~   "
114676|NCT02066428|"~     Phase I, randomized, double blinded, Placebo-controlled, immunogenicity and dose-range~     finding study of AERAS-404 in Bacille Calmette-Guerin (BCG) healthy adult male and sterile~     females.~   "
114677|NCT02066415|"~     To evaluate the effect of AMG 334 compared to placebo on the change from baseline in monthly~     migraine days~   "
114680|NCT02066363|"~     Clinical background: Weight loss is a common problem in patients suffering from~     gastrointestinal cancer. It is demonstrated that the prognosis for cancer patients with~     weight loss is worse than that for weight stable patients. Malnutrition in cancer patients is~     associated with a poor prognosis and is an important predictor of mortality. Supplementation~     with home parenteral nutrition in aphagic and terminal patients has shown improved quality of~     life, energy balance, body composition and prolonged survival.~      Aim: The aim of this study is primarily to study the effects of supplementation with~     parenteral nutrition, to patients with advanced incurable gastrointestinal cancer on lean~     body-mass and body composition. Patients found to be at nutritional risk will be included in~     the study and will be randomized to either best supportive nutritional care or best~     supportive nutritional care and supplemental Parenteral Nutrition.~      Design: This study is a controlled, randomized trial with two parallel study arms. The study~     will include patients with advanced GI cancers at nutritional risk, performance status 0-2~     and with an expected survival of a minimum of 3 months.~      A total of 100 patients are planned to be enrolled and randomized to either best supportive~     nutritional care or best supportive nutritional care and supplemental parenteral Nutrition.~      Primary endpoint is improvement of lean body mass, and by that improvement of quality of~     life, performance status and cancer treatment tolerance.~      Discussion: The planned study will provide important information about the effect of~     parenteral nutrition in a patient group with advanced gastrointestinal cancer. Palliative~     treatment strategies are set up to improve quality of life as well as prolongation of life.~     Parenteral nutrition in this patient group may indeed contribute to both these aspects of~     palliation.~   "
114681|NCT02066350|"~     Patients accepted for the waiting list for single pancreas transplantation suffer from severe~     glucose instability with hyperglycemia due to diabetes type 1, but do not have significant~     diabetes-related complications. Pancreas transplantation restores normoglycemia in diabetes~     type 1 patients with unstable control of glycemia. Both hypo- and hyperglycemic events are~     abolished, and 70-80 % of the patients obtain satisfactory HbA1c levels (HbA1c 5.0-6.0 %)~     without the need of exogenous insulin. Endothelial dysfunction is considered as an early and~     potentially reversible stage in the atherosclerotic process. The endothelium is involved in~     homeostasis, leucocyte adhesion and vasomotor activity. Reduced endothelium-dependent~     vasodilation is associated with increments in cardiovascular risk factors, and endothelial~     dysfunction is a predictor for future cardiovascular disease. It has also been hypothesized~     that endothelial dysfunction may be involved in the impaired glycemic control by reducing the~     availability of glucose in peripheral muscles.Establishing normoglycemia by pancreas~     transplantation alone in previously diabetic type 1 patients has recently been shown to~     improve left ventricular ejection fraction, assessed by Doppler echocardiographic~     examination. In diabetic patients receiving a new pancreas it is possible to assess the~     effect of changing blood glucose excursions on cardiovascular risk factors, including~     endothelial function, without the use of antidiabetic drugs (exclude pleiotropic effects).~      The primary objective of the present study is to assess if endothelial function (assessed by~     flow-mediated dilatation of arteria brachialis) is improved when hyperglycemia is reversed by~     single pancreas transplantation in patients with type 1 diabetes.~      Secondary objectives are to investigate the changes in the following parameters by reversal~     of hyperglycemia by pancreas transplantation; Peripheral arterial tonometry, serum/plasma~     concentrations of endothelial dysfunction markers, blood pressure, lipid and lipoprotein~     concentrations.~   "
114682|NCT02066337|"~     To evaluate the efficacy of locally delivered ozone gel as an adjunct to conventional~     periodontal therapy on selected clinical parameters as well as alveolar bone density (BD) and~     superoxide dismutase (SOD) activity in patient with chronic periodontitis.~   "
114683|NCT02066324|"~     The purpose of this study is to collect urine samples from patients with fibrodysplasia~     ossificans progressiva (FOP) for the assessment of biomarkers related to disease, disease~     progression and for prediction of flare-ups of the disease. Disease related biomarkers in~     these patients are currently unknown. This study aims to support the development of novel~     therapy/ies for this disease.~   "
114684|NCT02066311|"~     Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease in which the body's immune~     system attacks different parts of the body. SLE is characterized by inflammation that leads~     to tissue damage in different organ systems. Any organ system may be involved, including the~     skin, the joints, the kidneys, the nervous system, the heart, the lungs, and the blood. The~     exact cause of SLE is not known. Patients with SLE often have elevated levels of anti-double~     stranded DNA antibodies. These levels are often associated with disease flares and disease~     severity. These antibodies can bind to tissue leading to organ damage. Preventing these~     antibodies from binding to their targets may help decrease disease activity.~      Protease inhibitors are medications that have been approved by the Food and Drug~     Administration (FDA) for use in the treatment of HIV (human immunodeficiency virus).~     Nelfinavir (also called viracept) is one of these protease inhibitors. Separate from their~     anti-viral effects, protease inhibitors have been found to decrease inflammation. These~     medications have been shown to interfere with binding of anti-double stranded DNA antibodies~     to their targets and may decrease inflammation in SLE. This research study tests whether the~     protease inhibitor, nelfinavir, will decrease anti-double stranded DNA antibody binding and~     decrease disease activity.~   "
114685|NCT02066298|"~     Because approximately half of all mild-moderately-severe asthma is persistently~     non-eosinophilic, it is important to determine prospectively if patients who are persistently~     non-eosinophilic differ in their benefit from inhaled corticosteroid treatment compared to~     patients who are not persistently non-eosinophilic.~   "
114686|NCT02066285|"~     Phase II, open-label, non-randomized, international multicenter clinical trial with two~     strata (SFT and EMC). 8 sites in Spain, 5 sites in Italy and 5 sites in France. Patients will~     receive oral pazopanib at 800 mg once daily continuously. Patients will continue to receive~     treatment until there is evidence of progressive disease, unacceptable toxicity,~     non-compliance, withdrawn consent or investigator decision. The main goal is to determine the~     objective response rate (ORR) (confirmed complete response [CR] and partial response [PR]) in~     patients with unresectable, locally advanced or metastatic solitary fibrous tumor and~     extraskeletal myxoid chondrosarcoma, using Choi and RECIST 1.1 criteria respectively.~   "
114687|NCT02066272|"~     Anti-TNF (tumor necrosis factor) monoclonal antibodies have revolutionized management of~     Inflammatory bowel disease. Their common features include high efficacy but also~     immunogenicity and increased infection risk. Since 2013, two generics or biosimilars of the~     first anti-TNF have been registered in Europe, which long lerm safety profile needs yet to be~     established.~      This prospective, multicenter, observational cohort study will assess safety of treatment of~     anti-TNF monoclonal antibodies in inflammatory bowel disease patients in Poland.~      Eligible are consecutive patients in whom anti-TNF is started for Crohn's disease, ulcerative~     colitis or indeterminate colitis between January 1st, 2014 and December 31st, 2015. Data to~     be collected include demography, Montreal classification, indication to treatment, previous~     treatment, operations, extraintestinal manifestations and concomitant diseases. Data on~     response, tolerability and safety of anti-TNF and on concomitant treatment will be collected.~     Adverse events logs will be completed. Majority of IBD centres in Poland, pediatric and~     adult, academic and regional, have agreed to participate in the study.~      As a result of the study, the frequency of adverse events in a cohort of Polish IBD patients~     on various anti-TNFs will be established.~   "
114688|NCT02066259|"~     The OctavaColon tests are qualitative plasma tests that are indicated to people above 18~     years of age suspected with colon abnormality. The blood tests will provide additional~     information to the doctor in the course of colon cancer diagnosis for both normal population~     and high risk population~   "
114689|NCT02066246|"~     The aim of our study is to investigate if the use of the AirSeal insufflation system impairs~     the lung function of patients less than a conventional system in patients undergoing~     robot-assisted laparoscopic radical prostatectomy (RALP). Therefore we examine the lung~     function before and after surgery.~      As a second purpose of the study, in a subgroup, we investigate the influence of the gas~     insufflators (AirSeal and conventional) on hemodynamics during surgery. Furthermore we study~     the change in the lung perfusion-ventilation-ratio by using the electric impedance tomography~     technique.~   "
114690|NCT02066233|"~     The purpose of this study was to evaluate whether a disposable nasal endoscope called E.G.~     Scan II will visualize the esophagus as well as the standard test, sedated endoscopy.~   "
114691|NCT02066220|"~     The study PNET 5 MB has been designed for children with medulloblastoma of standard risk~     (according to the risk-group definitions which have been used so far; e.g. in PNET 4). With~     the advent of biological parameters for stratification into clinical medulloblastoma trials,~     the ß-catenin status will be the only criterion according to which study patients will be~     assigned to either treatment arm PNET 5 MB - LR or to PNET 5 MB - SR, respectively. The~     initial diagnostic assessments (imaging, staging, histology, and tumor biology) required for~     study entry are the same for both treatment arms.~   "
114692|NCT02066207|"~     The purpose of this study is to evaluate a pharmacokinetic drug interaction between~     atorvastatin and fenofibrate in healthy subjects.~   "
114693|NCT02066194|"~     Endoscopic ultrasound (EUS) has evolved to become an important diagnostic tool and its~     interventional role is rapidly expanding. In order to improve patient's comfort and~     satisfaction during and after procedure, the use of sedation is usually recommended. However,~     sedation may be associated with serious adverse events of including hypotension, aspiration~     and respiratory depression. Moreover, the cost of performing the procedure would be increased~     due to the costs of the medications and the need of additional personnel in monitoring of the~     patient. As a result, the drive to seek alternative and safer approaches of pain-relief~     during EUS is ever present. Electroacupuncture (EA) has been used in Traditional Chinese~     Medicine (TCM) for more than 2000 years. The benefits and success of EA in treatment of acute~     and chronic pain of various origins have been well-recognised. Many researches have been~     performed to address the role of EA in treating pain and anxiety during OGD and colonoscopy.~     However, only limited data is availabe in the Chinese and the Western literature concerning~     the use of EA in EUS. Therefore it is worthwhile to conduct a well-designed study to evaluate~     the role of EA in treating pain during EUS.~   "
114694|NCT02066181|"~     This randomized phase III trial compares the effects, good and/or bad, of sorafenib tosylate~     in treating patients with desmoid tumors or aggressive fibromatosis. Sorafenib tosylate may~     stop the growth of tumor cells by blocking some of the proteins needed for cell growth.~     [Funding Source - FDA OOPD]~   "
114695|NCT02066155|"~     African Americans are twice as likely to have diabetes compared to their White counterparts~     and experience higher rates of diabetes-related complications. Diabetes-related health~     disparities underscore the need for effective, culturally tailored approaches to promote and~     sustain diabetes self-management over time. Diabetes self-management education (DSME) is~     effective in improving diabetes outcomes in the short-term. However, many adults with~     diabetes cannot sustain achieved improvements without continued follow-up and support. The~     2012 revisions of both the National Standards for Diabetes Care 6 and the National Standards~     for DSME and Support emphasize the importance of providing both initial DSME and on-going~     diabetes self-management support (DSMS) to assist people with diabetes in maintaining~     effective self-management throughout a lifetime. While a great deal is understood about how~     to provide effective, initial DSME, less is known about who, where, when, and how to provide~     effective, sustained DSMS. One significant challenge is that DSME is a covered benefit in the~     healthcare system, while DSMS is not. This ultimately limits access and availability of DSMS~     programs, especially for low-income African Americans. Accordingly, there is critical need to~     develop, evaluate, and understand effective DSMS models that are ongoing, patient-driven, and~     embedded in the community.~   "
114696|NCT02066142|"~     Hypothesis The study aims to demonstrate at least equivalence, or non-significant difference~     between TS and US in women with dense breast screened negative at 2D Mammography.~      If the equivalence between TS and US will be demonstrated, US may be substituted by TS with~     great benefits for the patients and for the healthcare resources.~      Aims~        1. Assess if TS may detect additional cancers in dense breast that approximate US detection~          capability but with less false positive findings than US.~        2. If TS detects new cancers in dense breast similarly to US (approximate rate or~          marginally lower rate), evaluate the the true positive/false positive ratio.~        3. Cost-analysis. In case of less false positives detected by TS, the true-positive / false~          positive trade-off might be strongly in favour of TS with a great potential of costs~          reduction.~   "
114697|NCT02066129|"~     The objective of this study is to determine whether, in children receiving low-dose inhaled~     corticosteroids (ICS), quintupling the dose of inhaled corticosteroids at the onset of~     symptoms previously associated with upper respiratory illnesses and subsequent asthma~     exacerbations reduces the rate of severe asthma exacerbations treated with oral~     corticosteroids.~   "
114698|NCT02066116|"~     The investigators have developed the kinect-based upper extremity rehabilitation program and~     designed this protocol to prove the efficacy of this program.~      In brief, subacute stroke patients allocated to intervention group will receive the kinect~     based-rehabilitation program plus conventional occupational therapy and patients allocated to~     control group will receive the sham virtual rehabilitation plus conventional occupational~     therapy, for 10 days.~      20 patients with subacute stroke will be allocated into each group and after completing the~     10 days intervention, they will be assessed by using objective assessment tools for upper~     extremity function.~   "
114699|NCT02066103|"~     Assess the safety and feasibility of local oncological drug delivery into the bronchial wall~     after recanalization of subjects with malignant airway obstruction. Safety and feasibility~     (technical success) will be assessed.~      This localized delivery is intended as an adjunct therapy and all subjects will receive~     standard of care oncology therapy as determined by their treating physicians.~   "
114700|NCT02066090|"~     This research is planned to build a basis about the effect of acupuncture on serum metabolic~     parameters in pre-menopausal obese women with economic evaluation.~   "
114704|NCT02066038|"~     EGFR-tyrosine kinase inhibitor(TKI)- ie, erlotinib, gefitinib, has been recommended as the~     first option for EGFR-mutated IIIb/IV NSCLC by serial trials as it prolonged patients'~     progression-free survival. The OPTIMAl trial indicated that those who received TKI and~     chemotherapy during the whole treatment window survived longest. Unfortunately, previous~     studies(INTACT, TRIBUTE et al) that concurrently combined TKI and cytotoxic regimens failed~     to improve survival in unselected patients. To avoid the potential synergistic antagonism,~     the FAST-ACT II trial committed a sequential strategy and find a superiority in the~     combination arm upon chemotherapy even in EGFR-mutated group. However, pharmaceutically, the~     continuous administration of an EGFR-TKI before subsequent chemotherapy in FAST-ACT II could~     obviate the effects of cytotoxic agents due to the erlotinib-induced G1 arrest.~      On the basis of these and other studies, the investigators hypothesized that a better~     sequential combination strategy of EGFR-TKI and chemotherapy (adding a EGFR-TKI wash-out~     window before chemotherapy) would be more efficacious than chemotherapy alone. In this study,~     the investigators investigate the efficacy(PFS:progression free survival), safety, and~     adverse-event profile of chemotherapy plus intermittent and maintenance of erlotinib, when~     these drugs were used as first-line treatment in who had non-squamous lung carcinoma with~     EGFR gene mutation in China.~   "
114705|NCT02066025|"~     Octava has two versions, each with a different intend of use.~      OctavaPink is a qualitative in vitro diagnostic test service, performed by authorized~     clinical laboratories. The product is used for two following indications:~        -  Intend of Use #1: OctavaPink is indicated for women above 18 years old, who performed~          mammography and were determined negative for breast cancer. Being moderately sensitive~          (>55% sensitivity) the test is able to detect 55% of mammography false negatives. In~          addition, being highly specific (>95% specificity) it supplies additional evidence for~          true mammography negative result which will reduce examinees anxiety of being~          misdiagnosed as a result of high false negative mammography rate (10-30%)~        -  Intend of Use #2: OctavaPink is indicated for women above 18 years old, who performed~          biopsy after positive mammography and the biopsy result was negative. Being moderately~          sensitive (>55% sensitivity) the test is able to detect 55% of biopsy false negatives.~          In addition being highly specific (>95% specificity) it supplies an additional evidence~          for true biopsy negative result which reduces examinees anxiety of being misdiagnosed.~      OctavBlue is a qualitative in vitro diagnostic test service, performed by EventusDx~     authorized laboratories. Intend of use of OctavBlue is the following:~      • OctavBlue is indicated for women above 18 years old, who performed mammography and received~     doubtful results. Being highly sensitive (>95% sensitivity) the test can help to reveal 95%~     of positive cases; and being moderately specific (>55% specificity) - about half of negative~     cases. The test is not intended to be used as a standalone diagnostic technique but to supply~     additional information to a physician and help deciding about the further course of~     diagnosis.~   "
114706|NCT02066012|"~     Dysmetabolic iron overload syndrome (DIOS), is a frequent hepatic iron overload associated~     with metabolic syndrome. We hypothesize that this mild iron overload can induce a increased~     macrophagic polarization towards inflammatory types, thereby contributing to cardiovascular~     risk. Our main objective is to highlight the influence of iron overload on polarization~     capacity of monocytes into alternative macrophages (called M2). We therefore compare~     phenotypic markers of monocytes/macrophages between subjects with DIOS, metabolic syndrome~     without iron overload and lean subjects.~   "
114707|NCT02065999|"~     This is a multi-centre prospective longitudinal cohort study with the aim of collecting and~     storing clinical data, patient blood, DNA and PBMCs to examine outcomes related to drug~     resistance, drug monitoring and host genetics in the era of directly acting antiviral drugs~     for hepatitis C therapy.~   "
114708|NCT02065986|"~     This study is looking at a new way to reduce the risk of catching HIV - Truvada-PrEP.~      To find out whether a daily tablet, Truvada, can safely reduce the risk of gay men catching~     HIV, we need to do a large trial in which half the men do not receive Truvada for one year.~     We do not know if gay men at risk of HIV are interested in taking Truvada, and if they are,~     whether they would be willing to wait a year before they can take it. The reason it may not~     be safe, is that taking Truvada-PrEP may lead to an increase in risk behaviour. This could~     mean there was more chance of catching HIV and other infections.~      As well as finding out if a large trial would be possible, this study will looks at other~     factors including:~        -  Whether people using PrEP change the number of partners they have sex with~        -  Whether people using PrEP change how often they use condoms~        -  Whether PrEP leads to higher rates of other sexually transmitted infections (STIs).~      This information on changes in sexual activity over time is one of the most important aspects~     of the study, because we have never collected this before in the UK. This means we don't know~     what happens to people's sexual activity without PrEP! In October 2014 an interim analysis of~     the PROUD study data showed that pre-exposure prophylaxis (PrEP) was highly protective~     against HIV for gay men and other men who have sex with men (MSM) at high risk of infection.~     The PROUD Trial Steering Committee announced that participants on the deferred arm of the~     study, who had not yet started PrEP, should be offered the opportunity to begin PrEP ahead of~     schedule. As a result, we changed the study design and offered all enrolled participants the~     opportunity to access PrEP. All study participants will be followed up until study closure in~     October 2016~   "
114709|NCT02065973|"~     Phase I, open-label, sequential-cohort, ascending multiple-dose study to evaluate the safety~     and tolerability of escalating doses of PDS0101 in female subjects with high-risk HPV~     infection and biopsy-proven CIN1. The study will include 3 cohorts of 3 to 6 subjects each~     based on a modified 3 + 3 dose-escalation study design. The study will be initiated with~     Cohort 1 and progress through Cohort 3, with each subsequent cohort receiving a higher dose~     of PDS0101. Successive cohorts will receive a constant dose of HPV-16 E6 and E7 peptides. All~     subjects will receive 3 vaccinations SC given approximately 21 days apart. Dosing and dose~     escalation will be based on safety evaluation for determination of potential dose-limiting~     toxicity (DLT).~   "
114876|NCT02063802|"~     The purpose of this clinical trial is to examine the effects of conjugated linoleic acid~     (CLA) vs metformin along with an intervention program with healthy habits on body~     composition, weight, M value in CLAMP and clinical laboratory values, as well as molecular~     and genetic changes in obese children.~      Patients from the pediatric service of the Hospital from 8 to 18 years old with a body mass~     index ≥ Pc 95 and 35kg/m2 are randomized to either interventional group for 4 months.~   "
114710|NCT02065960|"~     Most women with early breast cancer are treated with breast conserving therapy (BCT),~     consisting of breast conserving surgery (surgery to remove the cancer itself) followed by~     radiation to the breast. This treatment can take time and is associated with its own side~     effect profile. An innovative radiation technique called stereotactic body radiotherapy~     (SBRT) can deliver large doses of radiation precisely to the tumour while avoiding critical~     organs, therefore destroying the cancer and avoiding surgery altogether. SBRT has been~     successfully used for a number of cancers and it is proposed that it could be used to~     eradicate breast cancer. This feasibility study will investigate the feasibility and safety~     of treatment using SBRT in women with early stage breast cancer.~      Thirty-two women age 70 years or older with early breast cancer will be treated with SBRT (5~     treatments) followed by breast conserving surgery and hormonal therapy. An MRI and breast~     conserving surgery will be performed at 8-12 weeks after radiation to assess response to~     treatment. The primary outcome of the study will be feasibility, meaning the ability to~     deliver radiation treatment as planned. Secondary outcomes will include treatment related~     toxicity and pathological response.~      If this study shows that SBRT can be used to treat patients primarily, it will lead to~     further evaluation of SBRT for early breast cancer.~   "
114711|NCT02065947|"~     The purpose of the study is to investigate if paravertebral block for breast surgery may~     improve postoperative analgesia and shorten length of hospital stay. Within a prospective~     clinical trial sixty women (ASA I - III) undergoing unilateral mastectomy surgery with~     axillary dissection are enrolled. Exclusion criteria are general infection and local~     infection at the site of planned puncture, anatomic deformities of the thoracic spine,~     coagulation disorders, allergy against local anesthetics or contrast agents, pregnancy or~     breast-feeding and BMI ≥ 30 kg/m2.~      Patients are randomly assigned to two groups, 30 patients each, by using block of four~     method. Group I patients receive paravertebral block at spine level Th 4 via catheter; Group~     II patients will have general anesthesia without nitrous oxide.~      Paravertebral block (PVB) will be entirely performed by one person (1st author) with the~     patient in prone position. In randomly selected patients the catheter localization will be~     detected by fluoroscopy after injection of 0.5 ml contrast agent. The catheter positioned at~     about 8 cm from skin level, a mixture of 10 ml bupivacaine 0.5% plus 20 ml lidocaine 2% with~     adrenaline 1:200,000 will be injected sequentially 10 ml each while withdrawing the catheter~     2 cm after the first and again 2 cm after the second injection. Then the catheter will be~     removed. Low dose intraoperative sedation is provided with IV midazolam 2-3 mg, ketamine 0.5~     mg/kg bolus and continuous propofol using target-controlled infusion (TCI) system aiming at~     effect site concentration (Ce) of 1 - 1.5 mcg/mL to allow spontaneous breathing. In case~     surgical approach is not tolerated, the regional block is graded insufficient, and it is~     switched to general anesthesia.~      At postoperative care unit (PACU) the pain score using visual rating scale (VRS) from 0 to 10~     (worst imaginable pain) is assessed at rest and on movement of the shoulder every 15 minutes~     until 60 minutes. Analgesia is provided by IV morphine 0.04 mg/kg boluses with a 15-min~     dosing interval to maintain VRS - score < 3. Time to first analgesic demand and 24-hr~     analgesics consumption is recorded as well as postoperative nausea and vomiting (PONV).~     Complications are recorded including those related to the paravertebral block, such as~     Horner's syndrome, epidural spreading, hypotension that is not related to another. Patients~     will be checked 6, 12, and 24hr postoperatively for adverse effects, pain scores, and~     satisfaction scores.~   "
114712|NCT02065934|"~     Clinical audit of in-hospital cardiac arrest management by in situ simulation~      Objectives: correct latent safety threats, knowledge gap, and crisis resource management~     (CRM)~      Design: clinical audit, observational sudy. Primary outcome: In Hospital resuscitation scale.~     Exploratory outcomes: non technical skills, validated stress inventory, and questionnaire on~     perceptions of the simulation and organisational changes needed.~   "
114713|NCT02065921|"~     1. Background Chronic Obstructive Pulmonary Disease (COPD) is an inflammatory disease of~          the lungs, which is most commonly caused by smoking. It is characterized as not fully~          reversible airflow limitation, chronic cough and dyspnoea. Being the fourth leading~          cause of death worldwide, COPD is an important public health challenge and can be~          prevented and treated. It is estimated that at least 400,000 individuals in Switzerland~          are affected by COPD. This number may increase in the coming years due to increasing~          nicotine consumption.~           In response to the rising trend, the Global Initiative for Chronic Obstructive Lung~          Disease (GOLD) has established new guidelines on the global strategy for diagnosis,~          management and prevention of COPD. Systematic diagnosis and stratification are crucial~          for effective treatment measures.~           As COPD is an irreversible and progressive disease, its treatment aims an early~          detection and better management, which leads preventing progression. Disease management~          programs have shown that only patients who understand their exacerbation symptoms can~          benefit. Moreover, it is a major goal to improve health-related quality of life by~          reducing symptoms and decelerating disease progression.~           Spirometry is the golden standard for the diagnosis of COPD, to assess the severity of~          the obstruction, and as a guide for optimal therapeutic measures.~        2. Aim of the study The objective of this project is to establish a COPD cohort database to~          allow high quality research on diagnosis, treatment, complication and progression of~          COPD on long-term course.~           Spirometry should be used consistently for the diagnosis and the monitoring of the~          development of the disease. Using collected information such as spirometric data,~          disease progression's data and therapeutic measures should help improve the management~          and self-management of the patients.~        3. Methods 3.1 Study design We are conducting a prospective cohort study, based on COPD~          patients from northern and western Switzerland, who are managed under primary care~          setting. Patients with mild to very severe COPD (GLOD stages I-IV) are enrolled in the~          study.~           Currently, 67 General practitioners (GPs) are participating in our Study. Each GP~          recruits 1-20 patients with presumed mild to very severe COPD according to criteria of~          the Global Initiative for Chronic Obstructive Lung disease [GOLD].~           Patients' follow-up-visits occurs at 6-month intervals; their history, symptoms and~          examination status is recorded. Data is entered into an online database either by the~          physicians or by study team after receiving the collected data questionnaires by~          facsimile.~           Data collection includes demographic data, physical examination, spirometric parameters,~          medical treatment and exacerbation history besides death.~           A spirometer (EasyOne™, ndd Medizintechnik AG, Zürich, Switzerland) is used to assess~          lung function. All participating physicians were instructed on the usage of the~          spirometer and on how to complete spirometry according to the guidelines. For the~          assessment of the severity of COPD, we use the spirometric data provided by the GPs. The~          COPD severity is interpreted according to criteria of the GOLD committee.~           3.2 Patient population Patients with newly diagnosed or existing COPD, who are managed~          in primary-care practices.~           3.3 Inclusion criteria~             -  Tiffenau (FEV17FVC) < 70 without reversibility (Increase in FEV1 after inhalation~               of a bronchodilator <200 ml and <12%).~             -  Age: > 40 years~             -  Both genders~             -  Smokers or ex-smokers of at least 20 pack years.~             -  Informed consent.~           3.4 Archiving and Data Retention All study-related records such as medical records,~          informed consent documents, information regarding participants who discontinued, and~          other pertinent data will be maintained and therefore retained as long as required by~          the applicable Swiss regulatory requirements (10 Years).~           3.5 Data security The complete data of the study will be entered anonymously into a~          database. The data is password-protected and can only be accessed by investigators and~          study members.~        4. Publication and authorship 4.1 Publication policy~      Authorship credit is based on:~        1. Substantial contribution to conception and design, acquisition of data, or analysis and~          interpretation of data.~        2. Drafting the article or revising it critically for important intellectual content.~        3. Final approval of the version to be published. Each author should have participated~          sufficiently in the work to take public responsibility for appropriate portions of the~          content.~   "
114714|NCT02065908|"~     In the proposed project the investigators will asses whether changes in expression of~     selected circulating microRNAs in serum could comprise a sensitive and specific biomarker of~     cardiotoxicity in cancer patients treated with anthracyclines based chemotherapy.~   "
114715|NCT02065895|"~     The purpose of this study is to test the ability of an advanced external Physiologic Insulin~     Delivery (ePID) algorithm (a step by step process used to develop a solution to a problem) to~     get acceptable meal responses over a range of gain. Gain is defined as how much insulin is~     given in response to a change in a patient's glucose level.~      This study also examines the effectiveness of the external Physiologic Insulin Delivery~     (ePID) closed-loop insulin delivery computer software. The investigators would like to assess~     whether fasting target levels can be achieved as the closed-loop gain increases or decreases,~     and to evaluate the system's ability to produce an acceptable breakfast meal response.~   "
114716|NCT02065882|"~     The purpose of the study is to investigate pharmacokinetics, efficacy and safety of BT524 in~     patients with congenital fibrinogen deficiency.~   "
114717|NCT02065869|"~     This study will evaluate pediatric patients with malignant or non-malignant blood cell~     disorders who are having a blood stem cell transplant depleted of T cell receptor (TCR) alfa~     and beta cells that comes from a partially matched family donor. The study will assess~     whether immune cells, called T cells, from the family donor, that are specially grown in the~     laboratory and given back to the patient along with the stem cell transplant can help the~     immune system recover faster after transplant. As a safety measure these T cells have been~     programmed with a self-destruct switch so that they can be destroyed if they start to react~     against tissues (Graft versus host disease).~   "
114718|NCT02065856|"~     This trial is an open, national, multi-centre trial. The trial will be initiated in December~     2013 and subjects will receive treatment for 6 weeks.~      Safety monitoring will be performed in an ongoing basis through a Clinical Safety Group with~     immediate access to Adverse Events registered in the clinical database. The composition,~     procedures and deliverables of the Clinical Safety Group will be detailed in a Safety~     Agreement prior to trial start.~   "
114719|NCT02065843|"~     This study was to compare the effectiveness of three drugs (Passiflora incarnata, Erythrina~     mulungum, Midazolam) in controlling anxiety in patients undergoing bilateral extraction of~     asymptomatic, impacted mandibular third molars.~   "
114720|NCT02065830|"~     The aim of this study will be to evaluate the safety and the efficacy of a new robotic~     exoskeleton device in subjects with Spinal Cord Injury (SCI) and in subjects with other~     neurological disease with an impairment of lower limbs.~   "
114721|NCT02065817|"~     This is a pilot study to determine the optimum time and dose to draw blood samples using a~     tracer for HDL kinetics.~   "
114877|NCT02063789|"~     Human immunoglobulin (Ig) is the most commonly used blood product. It has been well-defined~     the efficacy in patients with immunodeficiencies, Kawasaki disease, asthma and other immune~     diseases. It is expected that Ig 10% will improve the usefulness and safety profile compared~     to Ig 5% because it is expected the reduced hospitalization/treatment duration and less~     adverse events related to volume overload.~   "
114722|NCT02065804|"~     Groin hernia repair is a common procedure performed in approximately 2,000 patients per one~     million inhabitants. Severe chronic pain following groin hernia repair is seen in 2-5% of the~     patients indicating that a large number of patients each year suffer from debilitating~     reduction in health-related quality of life.~      This study examines the effect of ultra-sound guided blocks with local anesthesia in the~     groin in regard to pain relief and sleep quality.~      The hypothesis of the study is that a block will confer significant pain relief to patients~     with severe chronic pain following laparoscopical groin hernia repair.~   "
114723|NCT02065791|"~     The goal of this study is to assess whether canagliflozin has a renal and vascular protective~     effect in reducing the progression of renal impairment relative to placebo in participants~     with type 2 diabetes mellitus (T2DM), Stage 2 or 3 chronic kidney disease (CKD) and~     macroalbuminuria, who are receiving standard of care including a maximum tolerated labeled~     daily dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor~     blocker (ARB).~   "
114724|NCT02065778|"~     The purpose of this study was to study the safety and effect of stem cell therapy on the~     functional recovery in patients with chronic stroke.~   "
114725|NCT02065765|"~     The treating physician/investigator contacts Lilly when, based on their medical opinion, a~     patient meets the criteria for inclusion in the compassionate use program.~   "
114726|NCT02065752|"~     The purpose of this study is to assess the bioequivalence of the fixed dose combination (two~     components combined in one tablet) of canagliflozin and metformin extended release (XR)~     tablet (dose of 2 X 50 mg/500 mg) with respect to the individual components of canagliflozin~     (1 x 100 mg) and metformin XR tablet (2 x 500 mg) in healthy fed participants.~   "
114727|NCT02065739|"~     The purpose of this study is to assess the effects of repeated administration of 200 mg of~     itraconazole on the single-dose pharmacokinetics of JNJ-42165279 in healthy male~     participants.~   "
114728|NCT02065726|"~     Nutritional derangements are very common in cancer patients and negatively affect survival,~     morbidity and quality of life. Intervention trials have demonstrated that nutritional~     counseling can improve energy balance, nutritional status and quality of life in patients~     undergoing chemo-radiotherapy. Oxidative stress plays a role in the tumor-cytotoxic effect of~     cancer chemotherapy and radiotherapy but may also play a role therapy-related adverse events~     such as an impairment of nutritional status and quality of life. The nutritional properties~     of whey protein have recently raised attention. In view of the high content in cysteine these~     proteins can positively stimulate the synthesis of glutathione which, in turn, could~     contribute to the modulation of whole-body and cellular redox state. However, evidence on the~     role of this dietary intervention in cancer patients is limited.~   "
114729|NCT02065713|"~     Dactylitis is a poor prognostic factor in psoriatic arthritis (PsA) patients. The efficacy of~     synthetic or biologic disease modifying anti-rheumatic drugs (DMARDs) on dactylitis has not~     been previously studied in randomized controlled trials as a primary endpoint.~      In this investigator initiated clinical trial the investigators aim to test the hypothesis~     that the combination therapy of golimumab and methotrexate (MTX) will result in a significant~     improvement of dactylitis in comparison with MTX monotherapy, in MTX naïve psoriatic~     arthritis patients, at week 24. Similarly the efficacy on enthesitis, peripheral and axial~     involvement, skin and nail psoriasis, inflammation and damage of the feet and hands assessed~     by magnetic resonance imaging (MRI), composite indexes of disease activity, remission,~     function and quality of life will be determined.~      This is a national multicentre, interventional, double-blinded, placebo-controlled, parallel~     design trial. 136 patients with active dactylitis, refractory to at least two systemic~     non-steroidal anti-inflammatory drugs (NSAIDs), at optimal dosage, for 3 months will be~     included and centrally randomized to golimumab in combination with MTX versus MTX~     monotherapy, in a 1:1 ratio. The study duration will be 24 weeks.~      The investigators expect the results from this trial will contribute to a better definition~     of the treatment algorithm of PsA patients with dactylitis.~   "
114730|NCT02065700|"~     The primary objective of the study is to evaluate the long-term safety and tolerability of~     filgotinib (formerly GLPG0634) for the treatment of rheumatoid arthritis.~      Participants will be enrolled in this open-label long-term follow-up study after they have~     completed one of the two core studies, GLPG0634-CL-203 (DARWIN1) or GLPG0634-CL-204~     (DARWIN2), and will be evaluated for any side effects that may occur (long-term safety and~     tolerability) when taking filgotinib. During the course of the study, participants will also~     be examined for long-term effects of filgotinib administration on disease activity~     (efficacy), subjects' disability, fatigue, and quality of life.~   "
114731|NCT02065687|"~     This randomized phase II/III trial studies how well paclitaxel, carboplatin, and metformin~     hydrochloride works and compares it to paclitaxel, carboplatin, and placebo in treating~     patients with endometrial cancer that is stage III, IV, or has come back. Drugs used in~     chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth~     of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Metformin hydrochloride may help paclitaxel and carboplatin work better~     by making cancer cells more sensitive to the drugs. It is not yet known whether paclitaxel~     and carboplatin is more effective with or without metformin hydrochloride in treating~     endometrial cancer.~   "
114732|NCT02065674|"~     Objective: To ascertain whether homoeopathic medicine ABROMA AUGUSTA has a clinical role in~     changing the Glycated Hb Level in Diabetes mellitus Type II.~      Abstract:~      Background: Type 2 diabetes mellitus (T2DM) is one of the most important epidemic diseases in~     the world in this century, and accounts for 90% of cases of diabetes globally. Studies have~     suggested that Abroma Augusta plays a role in acute controlling blood glucose level. The aim~     of this study was to evaluate the efficacy of Abroma Augusta Ѳ in chronic control through~     GlycatedHb (HbA1c %) in Diabetes Mellitus Type 2 (NIDDM) as a pretest post-test study.~   "
114787|NCT02064959|"~     This randomized, prospective trial will study the effect of very early cooling in patients~     undergoing surgical evacuation of acute subdural hematomas (35°C prior to opening the dura~     followed by maintenance at 33°C for a minimum of 48h). Intravascular cooling catheters~     (Thermogard XP Device, Zoll) will be utilized to induce hypothermia or to maintain~     normothermia.~      The primary objective is to determine if rapid induction of hypothermia prior to emergent~     craniotomy for traumatic subdural hematoma (SDH) will improve outcome as measured by Glasgow~     Outcome Scale-Extended (GOSE) at 6 months.~   "
114733|NCT02065661|"~     EZ Holdco Inc. has developed two devices for the measurement of gastric content pH. The~     devices, EZ-NG and EZ-pH, rapidly check gastric pH by aspirating gastric contents into the~     device through a nasogastric (NG) tube and causing a color change in the device. The color~     change is then compared to the reference indicator on the device to determine a pH value of~     the aspirate. Currently there is no bedside rapid way to check gastric pH that protects the~     clinician from being exposed to the aspirate.~        1. Primary Objective To assess the accuracy of the pH measurement of gastric fluid on the~          devices by comparing the reading on the 2 devices to a standard clinically approved pH~          probe.~        2. Secondary Objective To determine what percentage of time the EZ-NG - RightSpot pH~          indicator could have been used to determine proper placement of the NG tube when~          initially placed.~   "
114734|NCT02065648|"~     The purpose of the study is to compare non-contrast abdominal MR Angiogram (MRA) syngo NATIVE~     sequence performed on a 3T Verio Siemens magnet to a standard contrast-enhanced MRA performed~     as part of routine clinical care in patients with normal renal function to determine if the~     non-contrast NATIVE sequence is a viable alternative to contrast enhanced MRA in patients~     with renal insufficiency. There are no interventions--this is an observational study.~   "
114735|NCT02065635|"~     -  Nitric oxide (NO) is a free radical in gas state which plays an important role in a~          variety of processes relevant to respiratory physiology. It represents a means of~          detecting airway hyperresponsiveness and appears to have a strong correlation with the~          eosinophilic infiltration of the airway. Patients who suffered bronchospasm or~          laryngospasm intraoperatively or postoperatively showed higher levels of exhaled NO.~        -  Propofol modifies NO production by stimulating the constitutive synthesis of NO and by~          inhibiting the inducible production of NO. It seems to exert protective effects on acute~          lung injury (ALI) in experimental models and it can possibly reduce exhaled NO. There is~          also evidence that some intravenous anesthetic agents can influence chemotaxis of~          eosinophils in vitro.~        -  Variation of exhaled NO and eosinophils in surgical patients undergoing anesthesia has~          not been studied before. Therefore, the aim of this study will be to investigate the~          differential impact of maintenance of general anesthesia with propofol versus~          maintenance with sevoflurane on exhaled NO and eosinophil blood count.~   "
114736|NCT02065622|"~     To evaluate safety and efficacy of two dosing regimens in achieving clinical remission in~     subjects with moderately to severely active Ulcerative Colitis.~   "
114737|NCT02065609|"~     The main purpose of this study is to see if Positron Emission Tomography (PET-Imaging) with~     89Zr labeled trastuzumab can detect trastuzumab (HER2) positive breast cancer.~   "
114738|NCT02065596|"~     This is a phase I/II study of patients with sickle cell disease. It aims to find out if~     people with sickle cell disease can be cured by changing their immune system before they have~     blood stem cell transplants. Doctors will give patients a new drug (fludarabine) to see if~     this drug changes patients immune system and reduces the patient's cells (host) from~     rejecting donor cells (graft) after the patient gets a Hematopoietic (blood) stem cell~     transplant.~   "
114739|NCT02065583|"~     This study will measure the accuracy of a disposable, non-invasive device for the continuous~     monitoring of abdominal sounds, called the AGIS sensor (Acoustic Gastro-Intestinal~     Surveillance) in predicting patients' intolerance to feeding (defined as severe nausea,~     vomiting, or need to place a nasogastric tube within 4 hours of initiating a standard feeding~     protocol) following abdominal surgery. This will be a pragmatic, observational study.~   "
114740|NCT02065570|"~     This study will evaluate higher versus standard adalimumab dosing regimens for induction and~     maintenance therapy in subjects with moderately to severely active Crohn's Disease and~     evidence of mucosal ulceration.~   "
114741|NCT02065557|"~     The purpose of the study is to demonstrate the efficacy and safety, and to assess the~     pharmacokinetics of adalimumab administered subcutaneously (SC) in pediatric subjects with~     moderate to severe ulcerative colitis (UC).~   "
114742|NCT02065544|"~     This is a study of the effects of weight loss and exercise training on glucose control as~     measured by the Hemoglobin A 1 C in individuals with recently diagnosed Type 2 Diabetes.~     Study outcomes are measured at 6 months. The primary outcome is the HBA1c at 6-months.~     Secondary outcomes include body weight, fitness, lipid profiles and HS-CRP, a measure of~     inflammation. The study hypothesis is that the program of weight loss and exercise will put~     >50% of individuals into remission of their type 2 Diabetes as measured by a HBA1c of <~     6.5%.~   "
114743|NCT02065531|"~     The purpose of the current randomized clinical trial was to compare the effectiveness of~     myofascial soft tissue release versus mobilization with impulse technique torsion (anterior)~     on pain, disability, and kinesiophobia in individuals with chronic non-specific low back~     pain.~   "
114744|NCT02065518|"~     The purpose of this project is to compare three treatment regimens for knee injury to the~     standard rehabilitation protocol: 1) NMES, 2) graduated strength walking (via a weighted~     vest), and 3) NMES combined with graduated strength walking. Each treatment arm will be~     supplemented by the standard of care and compared to a group who receive the standard~     rehabilitation only.~      The Study will compare the effects of NMES, Strength Walking and combined NMES/ Strength~     Walking on strength, mobility, symptomatology, and Quality of Life (QOL) in military members~     with knee injury to a standard rehabilitation protocol program only. All groups will~     participate in standard rehabilitation protocol. The groups will be assessed over 18 weeks to~     compare main and interactive effects over time.~   "
114745|NCT02065505|"~     To evaluate the efficacy of treatment with the Pilates Method in postural alignment and its~     correlation with the respiratory capacity of individuals with hemiparesis, with the aid of~     biomedical instrumentation, comparing the method performed in soil and therapy pool.~   "
114746|NCT02065492|"~     Children with thalassemia may have high iron levels after receiving blood transfusions. These~     high iron levels can have damaging effects on the body, especially the heart. Conventionally~     only chelation therapy was given for prevention of iron buildup in the heart. However,~     current research has shown that another drug, amlodipine, also helps to slow down the~     deposition of iron in the heart. This study is designed to see if patients receiving~     amlodipine along with their regular chelation therapy have a slower rate of iron buildup in~     the heart when compared with patients who are receiving chelation only.~   "
114747|NCT02065479|"~     Numerous studies have shown that pharmacodynamics (PD) response profiles vary among~     clopidogrel treated patients and that individuals with reduced response have an increased~     risk of recurrent ischemic events. There are multiple factors contributing to clopidogrel~     response variability, including genetic variations of the cytochrome P450 (CYP) 2C19 enzyme.~     In particular, loss-of-function (LOF) alleles of the CYP2C19 enzyme reduce transformation of~     clopidogrel pro-drug into its active metabolite. Thus, patients carrying LOF alleles have~     lower levels of clopidogrel's active metabolite as well as diminished platelet inhibition,~     which translates into an increased rate of adverse cardiovascular events, particularly in the~     setting of percutaneous coronary intervention (PCI). Prasugrel and ticagrelor are novel~     generation P2Y12 receptor inhibitors characterized by greater PD potency and reduced ischemic~     event rates compared with clopidogrel, and are not affected by CYP2C19 LOF polymorphisms.~     However, to date there are limited head-to-head PD comparisons between these two new P2Y12~     receptors blockers, and there are no studies assessing on how these agents behave among~     CYP2C19 LOF carriers. The aim of the present study is to compare the PD effects of prasugrel~     versus ticagrelor in patients undergoing PCI with CYP2C19 LOF alleles using the novel~     point-of-care genetic testing Spartan RX-CYP2C19 which permits accurate and rapid~     identification of CYP2C19 genetic status.~   "
114748|NCT02065466|"~     1.1. Primary Objectives~      1. To determine if nab-paclitaxel and temozolomide can be combined with full dose of~     bevacizumab for the therapy of patients with newly diagnosed brain metastases of metastatic~     malignant melanoma.~        -  To define the MTD of the combination (Phase I component).~        -  To determine progression free survival (Phase II component). 1.2. Secondary Objectives~             1. To separately evaluate the response rate and duration of both the brain and~               extra-cranial systemic metastases.~             2. To define the toxicity of the regimen.~             3. To tabulate the toxicity of the radiotherapy to the brain and compare with known~               toxicities of radiotherapy to the brain in melanoma and brain metastases.~             4. To use the data generated to plan definitive controlled clinical trials of the~               combination.~             5. To determine the overall response rate (Phase II component).~   "
114749|NCT02065453|"~     Over 600,000 hysterectomies are performed each year nationwide. Over 99% of these are~     accomplished laparoscopically in the investigators current surgical practice to allow women a~     quicker recovery than a traditional large incision. Disposable laparoscopic devices have been~     developed to assist in the completion of hysterectomies. These disposable energy sources are~     only used once, but offer an improved safety and energy profile in that they reliably control~     bleeding with little damage to surrounding tissue and potentially save time. Reusable energy~     instruments can be sterilized and reused for multiple cases. Operating room time is~     expensive. The investigators calculate that if 6.7 minutes of time can be saved using the~     disposable device, Ligasure (Covidien), versus the reusable Robi bipolar and Storz~     Laparoscopic Shears, the time savings could justify the cost of the device.~   "
114750|NCT02065440|"~     To determine whether ebastine/pseudoephedrine is effective on subacute cough.~   "
114751|NCT02065427|"~     The purpose of this study is to determine wether a multi-factor intervention involving the~     primary caregiver of a dependent patient, with the goal of improving his or her social and~     family support and carried out by the professionals of the patient's regular PHCT, will~     decrease the burden and increase quality of life for the primary caregiver.~   "
114752|NCT02065414|"~     Participants will be given special instructions about taking care of their teeth during the~     18 hours before they come to the dentist's office for screening/baseline, 1 week, 2 weeks and~     4 weeks. At that first visit, they will be examined by a dentist, who will examine their~     mouths with a dental instrument to determine whether they qualify to participate in the~     trial. Someone who works for the dentist will also take some oral measurements.~      Participants who qualify to be in the study will receive a treatment for their gingivitis and~     have an equal chance of being assigned to one of three treatment groups. Participants in all~     three groups will be given toothpaste that is already available in stores. They will brush~     their teeth twice daily in their regular manner. After brushing, participants in one group~     will use an experimental mouth rinse that is not available in stores. Another group will be~     given a mouth rinse to use that is already available in stores, and the third group will use~     a placebo mouth rinse. After they receive their assigned products participants will be~     supervised while they brush their teeth and rinse to ensure they understand exactly how to~     use the products. Participants will be required to stay at the site 20 minutes after the~     first use of product during visit 1 to monitor any potential allergic reaction. All other~     brushing and rinsing over the next four weeks will be at home, but participants will be~     required to keep a diary to record their brushing and rinsing times twice each day.~      Participants will be required to bring their diaries and any left-over toothpaste and mouth~     rinse with them for three more scheduled appointments after about 1 week, 2 weeks, and 4~     weeks. At those appointments, the dentist will examine their mouths, make sure there are no~     safety concerns, and examine again to get the measurements needed. One of the dentist's staff~     members will take other measurements as well.~      The study will determine the measured effects of the experimental mouth rinse on bleeding as~     a result of gingivitis, and compare these results to the mouth rinse that is already~     available.~   "
114753|NCT02065401|"~     The purpose of this study is to compare the pharmacokinetic profiles of deferitazole after~     administration of granule and tablet formulations of a deferitazole disodium salt to a~     capsule formulation of deferitazole magnesium hydroxide salt (reference formulation) in~     healthy adult subjects.~   "
114754|NCT02065388|"~     Purpose:~      Warfarin is now the most commonly used oral anticoagulant. This drug has inter-individual~     variability due to the genetic polymorphisms in the warfarin metabolizing enzyme, CYP2C9 and~     warfarin target, VKORC1. The investigators' team developed a pharmacogenetic dosing algorithm~     which can predict patients required warfarin dose, thus could prevent warfarin induced~     warfarin adverse events.~      Methods:~      The investigators recruited patients with indications for warfarin, the genotypes of VKORC1~     and CYP2C9 were determined by the hospitals and verified by National Center for Genome~     Medicine. The investigators then randomized the patients to one of three arms: 1. Warfarin~     dose predicted by dosing algorithm developed by the International Warfarin pharmacogenetic~     Consortium (IWPC), 2. Algorithm developed by the Taiwan Warfarin Consortium and 3. Standard~     of care. The investigators aimed to determine whether using genetic dosing algorithm can lead~     to more stable dose and safer use of the drug.~   "
114755|NCT02065375|"~     This study assesses the efficacy and safety of two concentrations of RTA 408 Ophthalmic~     Suspension in the treatment of patients who have inflammation and pain following ocular~     surgery.~   "
114788|NCT02064946|"~     The purpose of this study is to test the efficacy of a high-dose vitamin D supplementation~     regimen in reducing androgen deprivation therapy (ADT)-related side effects in older prostate~     cancer patients on ADT. The proposed study is a randomized, double-blind, 2-arm, controlled~     clinical trial that will accrue 76 prostate cancer patients without severe bone loss, aged 60~     and older, beginning ADT, and scheduled to receive at least 6 months more of ADT.~     Participants will be randomized to: 1) weekly high-dose vitamin D3 (50,000 IU) or 2) vitamin~     D placebo only for a period of 24 weeks. Both groups will also receive a daily multivitamin~     and calcium supplement.~   "
114756|NCT02065362|"~     Patients have nasopharyngeal carcinoma (NPC). This study is a gene transfer research study~     using special immune cells.~      Most patients with NPC show evidence of infection with the virus that causes infectious~     mononucleosis Epstein Barr virus (EBV) before or at the time of their diagnosis. EBV is found~     in the cancer cells of almost all patients with advanced stage NPC, suggesting that it may~     play a role in causing the disease. The cancer cells infected by EBV are able to hide from~     the body's immune system and escape destruction. We want to see if special white blood cells,~     called T cells, that have been trained to recognize and kill special parts of EBV infected~     cells can survive in patient's blood and affect the tumor.~      We already have given EBV-specific cytotoxic T cells to 30 patients with active NPC and have~     seen anti-tumor activity in 14 of 30 patients. We are now trying to find out if we can~     improve this treatment.~      First, we want to give T cells where more of the cells recognize at least two of the four EBV~     proteins expressed on NPC cells. We call these cells NPC-specific cytotoxic T cells.~      Second, we found that T cells work better if we add a receptor to the T cells called DNR~     (Dominant Negative Receptor). DNR makes T cells resistant to TGFbeta, a factor secreted by~     cancer cells that helps them escape being killed by the immune system. In this study we will~     therefore place the DNR gene into NPC-specific T cells (DNR.NPC-specific T cells).~      In other clinical studies using T cells, some investigators found that giving chemotherapy~     before the T cell infusion can improve the amount of time the T cells stay in the body and~     therefore the effect the T cells can have. Giving chemotherapy before a T cell infusion is~     called lymphodepletion since the chemotherapy is specifically chosen to decrease the number~     of lymphocytes in the body. Decreasing the number of patient's lymphocytes first should allow~     the T cells we infuse to expand and stay longer in their body, and potentially kill cancer~     cells more effectively.~      The chemotherapy we will use for lymphodepletion is a combination of cyclophosphamide and~     fludarabine. Cyclophosphamide and fludarabine are the chemotherapy agents most commonly used~     for lymphodepletion in immunotherapy clinical trials.~   "
114757|NCT02065349|"~     The purpose of this study is to assess the painkilling efficacy of ASP8477 relative to mock~     (placebo) in patients that have been diagnosed with painful diabetic peripheral neuropathy or~     postherpetic neuralgia determined by the change in the average daily pain intensity in~     patients that initially respond favorably to treatment with ASP8477.~   "
114758|NCT02065336|"~     The purpose of this study is to determine whether ARC-520 in combination with entecavir is~     effective in the treatment of patients with Chronic Hepatitis B Virus (HBV) Infection.~   "
114759|NCT02065323|"~     This study will evaluate if adding the investigational drug Dovitinib to standard androgen~     ablation therapy (ADT) is beneficial in prolonging the time to disease progression in~     patients with metastatic prostate cancer who are receiving ADT for the first time.~      Dovitinib belongs to the class of drugs known as tyrosine kinase receptor inhibitors.~     Tyrosine kinase receptor inhibitors have been shown to have anti-tumor effects and inhibit~     new blood vessel formation. New blood vessel development is necessary for the growth and~     spread of certain tumors, such as prostate cancer. It is thought that by inhibiting new blood~     vessel formation, any existing or new tumors may be unable to grow. Dovitinib targets~     existing cancer cells and also works to stop the formation of new blood vessels.~      Patients will be randomly assigned to received ADT alone or ADT plus Dovitinib. ADT will be~     administered per standard of care. Dovitinib will be taken by mouth once daily for 5~     continuous days, followed by 2 days with no Dovitinib. This schedule will repeat and continue~     until disease progression or removal from treatment for other reasons. Participants may start~     ADT prior to entering the study; however, treatment with Dovitinib must begin no later than~     120 days from the start of ADT.~      Participants will be asked to donate blood samples for research purposes; this is an optional~     part of the study. Research on blood samples will study circulating tumor cells and certain~     biomarkers (proteins on cells) to increase the understanding of prostate cancer and explore~     if certain biomarkers can help predict how tumors will react to treatment. Samples of~     existing tumor tissue will also be examined for research purposes.~   "
114760|NCT02065310|"~     The purpose of this study is to see if the CEdG assay can produce internally consistent~     results and initiate its validation as a biomarker for diabetes in humans.~   "
114761|NCT02065297|"~     The aim of this open, controlled, multicentre biomedical research study is to identify new~     markers specifically associated with Horton's disease. This would make it possible to improve~     the diagnosis and management of this disease.~      Participation consists in taking one or several blood samples depending on the group~     patients/controls.~   "
114762|NCT02065284|"~     Rhythmic Auditory Stimulation (RAS) is a music therapy technique that provides rhythmic~     auditory cues (like a beat) to help improve patients' movements, especially when walking.~      The purpose of this study is to compare the effect on walking performance of a home based~     walking program (HBWP) with Rhythmic Auditory Stimulation (RAS), to that of a HBWP without~     RAS, or to RAS without walking exercise.~      A second part of this study will assess the effects of Rhythmic Auditory Stimulation (RAS) on~     brain activity in patients with Multiple Sclerosis while performing mental imagery of~     walking.~   "
114763|NCT02065271|"~     Rationale: The incidence of obesity and type 2 diabetes (T2D) is increasing rapidly and~     accounts for a considerable part of health care costs. Herbal supplements are used in many~     cultures for the prevention and treatment of many different conditions. Due to lack of~     scientific proof, the application in western cultures are minimal. Animal studies have shown~     that many constituents of such herbal supplements may have beneficial effects on several~     important parameters known to be affected in T2D. Still, no scientific proof in humans is~     available. We therefore aim to investigate the effect of 4-week herbal supplementation on~     glucose metabolism, lipid metabolism, vascular function and inflammation in subjects with~     increased fasting glucose levels or a decreased glucose tolerance.~      Objective: The primary objectives are to investigate if 4-week herbal supplementation in~     subjects with increased fasting glucose levels or a decreased glucose tolerance has a~     positive effect on blood glucose levels and glucose tolerance. The secondary objectives are~     to investigate if 4-week herbal supplementation in subjects with increased fasting glucose~     levels or a decreased glucose tolerance has a positive effect on triglycerides (TG), total~     cholesterol (TC), low density lipoprotein (LDL), high density lipoprotein (HDL) levels,~     inflammation, adipose tissue and white blood cell gene-expression and AIX both fasted and~     during an OGTT test.~      Study design: This study is a randomized, double-blind, placebo controlled cross-over trial~     in which two different treatments will be evaluated e.g. an intervention with the herbal~     mixture and a placebo. Each person will obtain both treatments in random order for four weeks~     with a wash out period of four weeks in-between. Fasting blood samples will be collected and~     subjects will receive a OGTT, paralleled by a PWA before and after 4-week supplementation.~      Furthermore, after 4-week supplement intake we will collect a urine sample and collect an~     adipose tissue biopsy. The whole trial will last three months.~      Study population: 26 overweight males and females 50-75yrs old with an increased fasting~     glucose or with an impaired glucose tolerance.~      Intervention: Two intervention periods of 4-weeks in which participants will take three times~     a day a supplement of 500mg herbal or placebo.~      Main study parameters/endpoints: Fasting blood glucose levels, glucose tolerance as~     determined by an oral glucose tolerance test (OGTT), AIX, triglycerides (TG), total~     cholesterol (TC), low density lipoprotein (LDL), high density lipoprotein (HDL) levels, PWA,~     adipose tissue an white blood cell gene expression and markers of inflammation .~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: Subjects that will participate in the study will invest a total of 16.5 hours.~     Blood collection by vena punctures/insertion of the venflon and the collection of an adipose~     tissue biopsy can occasionally cause a local hematoma or bruise and some participants may~     report pain or discomfort. The herbal supplements contain small amounts St. John's wort,~     which may affect the function of liver enzymes. We will therefore monitor liver function~     parameters during the supplementation period. Furthermore, subjects are excluded if they use~     medication known to be affected by St. John's wort. Participant will donate 284ml of blood,~     dispersed over 12 weeks.~   "
114837|NCT02064309|"~     The primary objective of this clinical investigation is to investigate the safety of~     implantation of the human islet containing device Beta-Air in type 1 diabetic subjects.~      The secondary objective of this clinical investigation is to investigate if the~     transplantation of macro-encapsulated human islets within the Beta-Air device can provide~     improved glycaemic control in type 1 diabetes patients with reduced incidences of~     hypoglycaemic episodes.~   "
114764|NCT02065258|"~     Background: Asthma is a chronic inflammatory airway disease characterized by reversible~     obstruction, inflammation and hyperresponsiveness to different stimulus. Aerobic and~     breathing exercises have been demonstrated to benefit asthmatic patients; however, there is~     no evidence comparing the effectiveness of the treatments. Objective: To compare the effects~     of aerobic and breathing exercises on clinical control (primary outcome), psychosocial~     morbidity and daily life physical activity (secondary outcome) in patients with~     moderate-to-severe persistent asthma. In addition, thoracoabdominal kinematics, heart rate~     variability and airway and systemic inflammation will be evaluated. The initial hypothesis~     will be that both exercises present improved clinical control of asthma. Methods: Forty-eight~     asthmatic adults will be randomly divided into 2 groups: aerobic (AG) and breathing exercises~     (BG). All treatments will be performed twice a week for 3 months, totalizing 24 sessions of~     40 minutes each. Both groups will complete an educational program consisting of 2 classes at~     the beginning of the interventions. Before and after interventions, the following parameters~     will be quantified: clinical control, health related quality of life, levels of anxiety and~     depression, maximal exercise capacity, autonomic nervous imbalance, daily living physical~     activity, thoracoabdominal kinematics, inflammatory cells in the sputum, fraction of exhaled~     nitric oxide (FENO) and systemic inflammatory cytokines. Asthma symptoms will be quantified~     monthly using diaries. Kolmogorov-Smirnov test will be used to analyze the data normality,~     and a two-way ANOVA with repeated measures with appropriate post hoc test (Student Newman~     Keuls) will be used to compare the inter and intra-groups differences~   "
114765|NCT02065245|"~     Before initiating the full randomized study, a Pilot Safety Phase will be performed. The~     randomized portion of this trial will be conducted after a full review of the safety data~     from the Pilot Phase by the Data safety monitoring board.~      Following the Pilot Phase of fifteen (15) subjects, up to thirty (30) subjects are scheduled~     to undergo infusion and meeting all inclusion/exclusion criteria will be evaluate at~     baseline.~      An additional twenty (20) subjects will be enrolled in a safety trial for antibiotic free~     cells.~   "
114766|NCT02065232|"~     This is a pain survey study that will compare the level of discomfort experienced by breast~     cancer patients after injection of either technetium-labeled sulfur colloid or~     technetium-labeled tilmanocept, both FDA-approved agents used for sentinel lymph node biopsy~     (SLNB). Breast cancer patients who are already scheduled for SLNB as part of their original~     surgical plan will be asked to participate in this study and be randomized to receive either~     technetium-labeled sulfur colloid or technetium-labeled tilmanocept. After injection,~     patients will complete pain questionnaires to measure the amount of discomfort they are~     feeling during and after they receive the injection. There will be no change to the patient's~     treatment plan other than the addition of pain questionnaires. The investigators' hypothesis~     is that patients will feel less discomfort after injection of tilmanocept versus sulfur~     colloid.~   "
114767|NCT02065219|"~     Groin hernia repair is a common procedure performed in approximately 2,000 patients per one~     million inhabitants. Severe chronic pain following groin hernia repair is seen in 2-5% of the~     patients indicating that a large number of patients each year suffer from debilitating~     reduction in health-related quality of life.~      This study examines the effect of ultra-sound guided blocks with local anesthesia in the~     groin in regard to pain relief and sleep quality.~      The hypothesis of the study is that a block will confer significant pain relief to patients~     with severe chronic pain following open groin hernia repair.~   "
114768|NCT02065206|"~     While few students may consider a career in research at baseline, receiving information from~     peers via online social networks represents a potential way of reaching underserved minority~     students.~      This study addresses a critical problem in the process to diversify the pipeline of clinical~     researchers - how to cultivate baseline interest in research among high achieving youth~     before they participate in pipeline programs. We will seek to challenge existing paradigms of~     studying effectiveness of interventions to promote entry of minority youth into clinical~     research careers through testing a novel social media campaign that aims to increase interest~     in research careers among schoolmates of students in a pipeline program. We are testing the~     use of of peer-created and inspired videos about career choice as a novel way to develop~     messages that have potential to influence teens.~      Should this research program be successful, it will yield valuable insights for researchers~     and educators who are attempting to train minority students about the importance of involving~     youth in creating materials to recruit and retain minorities into pipeline programs and~     educational programs targeted towards clinical research.~   "
114769|NCT02065193|"~     The China SCORE study is a prevalence study of Autism Spectrum Conditions (ASC) in 14 regions~     in mainland China. It will include the following steps:~        1. Large population-based screening This study will be conducted in urban areas but not~          rural areas across mainland China. One city of each region will participate, and in~          total there will be 14 cities for screening. Within each city, a number of 40 to 60~          ordinary primary schools will be randomly selected from the defined region. All the~          students who are in 1st to 4th grade will asked to participate in order to form a sample~          of approximately 20,000 students.~           Screening questionnaires The screening pack includes the Chinese CAST, the AQ-Child, the~          AQ-Adult short version (10 items), and risk factors questionnaire. An information sheet~          and consent form will be included in the pack as well.~        2. Further assessments We expect approximately 5% on the CAST will score positive in~          ordinary school population. Thus, for a 20,000 sample, we would expect 900 positives~          (90% response rate). All the screen-positives and a random selected 5% from borderline~          group will be invited for clinical assessment. The diagnosis of clinical assessment will~          be divided into three categories: definite ASC, suspected ASC, and non-ASC. Then all the~          children with clinical assessment results as definite ASC and suspected ASC and a~          randomly selected 10-20 non-ASC will be invited for research diagnostic assessment using~          the ADOS and ADI-R, as well as RPM as IQ test. After that, the consensus diagnosis~          between ADOS/ADI-R assessment and the clinical diagnosis will be the final diagnosis.~        3. Case identification in special schools All the children in special schools or training~          institutes in study region will be asked to fill in the screening pack. The children who~          do not attend any ordinary or special schools will be identified according to their~          residential ID in the studied regions. All screen-positives in special education will be~          assessed using the ADOS and ADI-R. Then those who met the criteria of ASC on ADOS or/and~          ADI-R will be assessed by psychiatrists and the clinical diagnosis will be the final~          diagnosis.~      If we combine the prevalence of ordinary schools and special schools together, we will get an~     estimate of the prevalence of ASC in school-population in China. If we combine all the cases~     identified from schools and from residential records, we will generate an estimate of the~     prevalence of ASC in the general population in mainland China.~   "
114770|NCT02065180|"~     This randomised controlled trial studies the effect of a commercially available nutritional~     supplement on cholesterol levels in people with metabolic syndrome and elevated cholesterol~     levels.~   "
114771|NCT02065167|"~     The purpose is to assess the safety and feasibility of cellular therapy derived from bone~     marrow, to help bone healing in patients with avascular necrosis of the hip.~   "
114900|NCT02063490|"~     The study aim is to test the efficacy of one-year nurse-led interventions to improve the~     medication intake behaviour of chronic dialysis patients. The investigators hypothesis is the~     interventions leading to a 15% mean increase in intake, compared to standard care.~   "
114772|NCT02065154|"~     The main purpose of this study is to assess the effects of cyclophosphamide (cytoxan) in the~     post transplant setting to prevent onset of acute graft-versus-host disease (GVHD). The~     primary objective is to determine the incidence of grade II-IV acute GVHD following~     Allogeneic (allo) Hematopoeitic Cell Transplant (HCT) using post-transplant cyclophosphamide~     (cytoxan) for patients with human leukocyte antigen (HLA) matched unrelated (MUD) and~     mismatched unrelated (MMUD) donors. Other objectives for this study will be the determination~     of disease-free survival (DFS) and overall survival (OS) following allo HCT and assess the~     safety of post-transplant cyclophosphamide (cytoxan) for MUD and MMUD transplantation.~     Disease recurrence and time to recurrence in patients receiving post-transplant~     cyclophosphamide compared to historical control without post-transplant cyclophosphamide~     (cytoxan) will also be evaluated. Other objectives will be to determine the time of onset,~     severity, responsiveness to treatment, organs involved of acute and chronic GVHD as well as~     observation of Immune Reconstitution over time.~   "
114773|NCT02065141|"~     The aim of the present study is to validate a new method in healthy volunteers and those~     diagnosed with COPD and CHF that is able to measure protein digestion and absorption~     simultaneously. This method is used to quantify digestion and absorption in patients who are~     suspect of impaired digestion and absorption resulting in loss of nutrients.Findings may be~     used to develop treatment strategies to improve protein digestion and absorption in these~     patient groups.~   "
114774|NCT02065128|"~     Irritable larynx syndrome (ILS) is a hyperkinetic laryngeal dysfunction that is characterized~     by a persistent cough, voice changes, or breathing difficulties, which are often triggered by~     an irritant. Diagnosis of ILS is difficult and typically made via a thorough review of the~     clinical history and, occasionally, the patient's reaction to an odor-provocation test.~     Standard treatment for ILS is behavioural therapy with a speech language pathologist (SLP),~     which provides symptom improvement for most patients. However, currently, there are no~     objective measures of the upper airway hyper-responsiveness in this condition to assist in~     diagnosing and monitoring disease severity.~      Since the cough is irritant-based, it is anticipated that patients with ILS will have a~     hypersensitivity to the irritant capsaicin. Capsaicin is the active component of chili~     peppers and is what makes them hot. The capsaicin cough challenge is a well recognized test~     that involves inhaling different concentrations of capsaicin solutions to determine a cough~     reflex sensitivity.~      The purpose of this research study is to confirm that ILS patients have a hypersensitivity to~     capsaicin compared to healthy volunteers. If a hypersensitivity is observed in ILS patients,~     the second objective of this study will be to see if behavioural therapy improves the cough~     reflex sensitivity in this patient population.~   "
114775|NCT02065115|"~     This study seeks to determine if cryoanalgesia in the form of ice application could be an~     effective analgesic when applied before arterial puncture.~   "
114776|NCT02065102|"~     Coronary artery stenting has evolved as an effective treatment for angina and involves~     stretching up narrowings within the heart arteries using a balloon (coronary angioplasty)~     before implanting a small metal scaffold (stent) to splint the artery open. It is imperative~     that stents are fully expanded when they are deployed. If not, then patients are exposed to~     the serious risk of a blood clot forming in the stent (stent thrombosis), or the stent~     renarrowing (restenosis). One fifth of patients experiencing stent thrombosis will die and~     70% will suffer a heart attack. Restenosis is associated with recurrent angina and heart~     attacks.~      Arguably, visualising stents and ensuring adequate stent expansion is most challenging in~     patients with extensive hardening, or calcification, of the heart arteries. Optical coherence~     tomography is a novel technique that utilises near-infrared light to look inside small blood~     vessels in fine detail. It is 10 times more powerful than the best existing technique,~     intravascular ultrasound.~      The purpose of this study is to compare the utility of optical coherence tomography with~     intravascular ultrasound in patients with heavily calcified heart arteries undergoing~     rotational atherectomy and coronary stent insertion. It is hoped that the results of this~     pilot study will provide proof-of-principle and justification for a larger clinical trial to~     formally assess the role of optical coherence tomography to guide coronary angioplasty and~     stenting in patients with heavily calcified coronary arteries.~   "
114777|NCT02065089|"~     We would like to collaborate and further develop an ipad-based, interactive quiz game 'Emma';~     to identify gaps in knowledge of inflammatory bowel disease in pediatric patients. These gaps~     can be used to improve patient education.~   "
114778|NCT02065076|"~     The purpose of this trial is to determine if sodium polystyrene sulfonate (SPS) is an~     effective treatment of mild hyperkalemia in chronic kidney disease patients followed at a~     pre-dialysis or nephrology outpatient clinic. Subjects will be randomized to one of two~     treatment arms: 30 g of placebo or SPS to be taken orally once daily for seven days. The~     change in serum potassium levels will be compared in both treatment groups. The proportion of~     subjects attaining normokalemia (3.5 to 5.0 mmol/L) after seven days of treatment will also~     be compared. Finally, side effects will be reported for each treatment arm.~   "
114779|NCT02065063|"~     This is a dose-escalation, Phase I/II, open-label, three-part study. Part 1 is designed to~     determine the recommended dose and schedule for the orally administered MEK inhibitor~     trametinib, given together with the CDK4/6 inhibitor palbociclib in subjects with solid~     tumors. Multiple dose levels of each inhibitor will be tested to determine the recommended~     dose and schedule. Part 2 will evaluate the effect of the combination on tumor biomarkers~     safety, and anti-cancer activity in subjects with cutaneous melanoma that do not have a~     change at BRAFV600. Approximately 100-200 subjects will be enrolled. All subjects will~     receive trametinib and/or palbociclib until disease progression, death, consent withdrawal or~     unacceptable adverse event (AE).~      Data was only collected and analyzed for the Phase I component of the study, the Phase II~     component of the study was terminated without data collection~   "
114838|NCT02064296|"~     The aim of this study is to evaluate the impact of electro-acupuncture in pain processing on~     patients with fibromyalgia (FM). The investigators hypothesize that electro-acupuncture is~     effective for FM because it functions as a desensitization therapy, which when applied~     repeatedly over multiple treatment sessions, gradually habituates the nervous system to~     continuing pain and sensory signaling.~   "
114839|NCT02064283|"~     This study will evaluate the feasibility of identifying changes in diffusion MRI~     characteristics of bone that correlates with response to therapy in men with metastatic~     prostate cancer.~   "
114780|NCT02065050|"~     This study is being performed to evaluate whether a comprehensive discharge planning and~     close follow up for one year can improve clinical outcomes and cut costs of care for patients~     with poorly controlled diabetes. The study takes a high risk approach and is focused on~     patients admitted to hospital for elective surgery with HbA1c >8%. Secondary goals include~     improving teamwork and communication for clinicians within the team and teaching nurse~     practitioners and physicians-in-training how to work effectively within interdisciplinary~     teams. Investigators anticipate that the results of this project may lead to the following~     benefits: 1) improved health outcomes for surgical patients with diabetes, 2) improved~     strategies for better communication within interdisciplinary health care teams, and 3)~     decreased health care costs.~   "
114781|NCT02065037|"~     Colorectal cancer is the second most common cancer in the world and the second leading cause~     of cancer-related mortality. Colorectal cancers arise from precursor adenomatous polyps in a~     well characterized adenoma to carcinoma progression. The removal of such precursor lesions~     reduces colorectal cancer mortality between 30 to 50%. Colonoscopy is used for detection of~     neoplastic polyps but significant miss rates of such lesions are reported. Methods to reduce~     spasm of the colon have been investigated to increase adenoma detection rates including the~     use of warm water irrigation and hyoscine butyl bromide. Carbon dioxide warmed to body~     temperature is postulated to have spasmolytic effects. Administration of warmed carbon~     dioxide during colonoscopy may improve polyp detection.~      Objective: In this study, colonoscopy using warmed carbon dioxide insufflation will be~     compared to standard room temperature air insufflation to see if there is a greater detection~     of polyps per patient.~      Methods: Patients undergoing colonoscopy for screening and surveillance indications will be~     included and randomized to receive either room temperature room air or warmed carbon dioxide~     (37 degrees Celsius). Endoscopists and patients will be blinded to the intervention. Data on~     indication, preparation, sedation, withdrawal time will be recorded. Polyp detection rate~     will be the primary outcome. Secondary outcomes will include adenoma detection rate and~     advanced lesion detection rates.~   "
114782|NCT02065024|"~     Regular consumption of a beverage containing β-cryptoxanthin (b-Cx) and plant sterols (Ps)~     has been shown to exert a synergic effect in reducing cardiovascular risk and bone remodeling~     markers (formation and resorption). The present project aims to assess the influence of~     technological treatment and genetic variability on the bioavailability and the health effects~     of the added components (Ps, b-Cx), in particular to their potential role in prevalent~     disorders.In vitro and in vivo studies will be carried out to this effect. In vitro and in~     vivo studies (human intervention study) will be performed and cardiovascular, bone turnover~     and inflammation markers will be evaluated. Additionally, an in vitro colonic fermentation~     model and cell cultures will be used to explore anticarcinogenic effects and potential~     cytotoxicity.~   "
114783|NCT02065011|"~     Primary Objective:~      To evaluate the long-term safety and tolerability of UshStat® in patients with Usher syndrome~     type 1B~      Secondary Objective:~      To assess long-term safety and biological activity of UshStat®~   "
114784|NCT02064998|"~     The purpose of this study is to evaluate the efficacy of three mobile phone applications,~     Promillekoll, PartyPlanner and TeleCoach among university student union members with~     problematic drinking. Two trials are conducted, one a three-armed randomized controlled~     study, and the second a two-armed randomized control study. Outcomes are measured in terms of~     changes in problematic alcohol use at follow up 6,12 and 18 weeks after baseline data~     gathering. Both the Promillekoll and PartyPlanner apps feature real time registration of~     alcohol consumption and give feedback of estimated blood alcohol concentration levels.~     PartyPlanner also allows for planning an alcohol consumption event in advance and for later~     comparison of the plan with actual consumption. Study 1 compares these two apps with a~     control group. In Study 2, participants reporting alcohol consumption above the weekly~     recommended level are redirected to randomized assignment to an in-depth app, TeleCoach,~     which offers different exercises for reducing alcohol use. After 6 weeks the controls are~     offered the TeleCoach intervention for 6 weeks, and the first intervention group loses app~     access. In both studies, followup occurs 6, 12 and 18 weeks after baseline registration.~      Hypotheses:~      Study 1: 1. The groups receiving the Promillekoll and PartyPlanner interventions will reduce~     their alcohol use to a larger extent than the control group at follow-up compared to the~     baseline level. 2. The planning function in PartyPlanner will be associated with an increased~     decrease in alcohol consumption compared to only real-time use for Promillekoll.~      Study 2: The proportion of participants with risky use above recommended levels will decline~     faster in the group that receives the intervention first, in comparison to controls.~   "
114785|NCT02064985|"~     open label, single centre, randomised, Phase IV, pharmacokinetic, pharmacodynamic, and safety~     study to evaluate single and multiple doses of 45, 60, and 90 mg of ticagrelor in Chinese~     patients with stable coronary heart disease~   "
114786|NCT02064972|"~     In consideration of the fact that the vascular endothelium has been shown to be a target of~     GvHD in early stage and that the count of CEC may represent a marker of endothelial damage,~     we want to evaluate the changes in CEC counts of patients affected by hematological disorders~     undergoing allo-HSCT, as a function of endothelial damage. We will enroll 50 patients~     affected by hematologic disorders undergoing allo-HSCT. Peripheral blood will be drawn before~     (T1, baseline) and at the end of the conditioning regimen (T2, pre-transplant), upon~     confirmation of hematopoietic recovery (T3, engraftment) and thereafter at onset of GVHD~     (GVHD T4) and one week after the start of steroid therapy (T5, post-GvHD). All patients will~     also be checked for CEC at day + 28. CEC enumeration will be performed by using the~     CellSearch® System and a flowcytometry procedure.~      Through the conduct of this study, we expect to confirm our preliminary results on a larger~     series of patients, and to evaluate the predictive role of CEC on the occurrence of GvHD and~     prognostic response to treatment of GvHD. The possibility of early identification of patients~     who do not respond to traditional treatments of GvHD, and for this reason at a higher risk of~     morbidity and mortality, may allow greater individualization of the therapeutic program, for~     example with the introduction as early as possible of alternative treatments. In addition,~     the identification of patients at higher risk of non-responsiveness to steroid treatment,~     would allow, through a closer monitoring, the early introduction of additional treatment~     before the development of resistance/refractoriness to treatment of GvHD.~      The present study takes the form of a prospective study. The primary endpoint is the~     identification and enumeration of CECs in peripheral blood of patients with hematological~     disorder undergoing allo-HSCT, as a function of endothelial damage. The secondary endpoint is~     to define the prognostic and predictive value of the changes of CEC counts on the diagnosis~     of GvHD and response to treatment.~   "
114840|NCT02064270|"~     The aim of this study is to assess the prevention of incision healing complications in~     patients undergoing Total Knee Arthroscopy (TKA) and Total Hip Arthroscopy (THA) treated with~     either Single-Use Incisional NPWT (Negative Pressure Wound Therapy), or standard of care~     dressings.~   "
114789|NCT02064933|"~     Wiskott - Aldrich syndrome (WAS) is a rare serious medical condition that causes problems~     both with the immune system and with easy bruising and bleeding. The immune abnormalities~     cause patients with WAS to be very susceptible to infections. Depending on the specific type~     of primary immune deficiency diseases, there are effective treatments, including antibiotics,~     cellular therapy and gene therapy, but studies of large numbers of patients are needed to~     determine the full range of causes, natural history, or the best methods of treatment for~     long term success.~      This multicenter study combines retrospective, prospective and cross-sectional analyses of~     the transplant experiences for patients with WAS who have already received HCT since 1990, or~     who will undergo Hematopoietic cell transplant (HCT) during the study period. The~     retrospective and prospective portions of the study will address the impact of a number of~     pre and post-transplant factors on post-transplant disease correction and ultimate benefit~     from HCT and the cross-sectional portion of the study will assess the benefit of HCT 2 years~     post-HCT in consenting surviving patients.~   "
114790|NCT02064920|"~     This study aims to determine whether the Cogstate testing battery can detect improvements in~     cognitive function in participants with mild AD. The primary hypothesis is that for one of~     the Cogstate battery tests, One Card Learning (OCL), the standard deviation associated with~     the change from baseline in OCL measurements after 12 weeks of donepezil and placebo~     treatments is =<0.1~   "
114791|NCT02064907|"~     The purpose of this study is to assess the pharmacokinetics (PK) and Pharmacodynamics (PD) of~     dexlansoprazole delayed-release orally disintegrating (OD) tablets administered on the tongue~     and swallowed without water.~   "
114792|NCT02064894|"~     Pain management for children presenting to the emergency department (ED) with an injured limb~     is often under-treated, even though it is known that broken arms and legs cause moderate to~     severe pain. Further, children are less likely to receive appropriate pain medicine than~     adults with similar injuries. This study aims to improve the pain treatment of children who~     present to the ED with a suspected fracture, or broken bone or severe sprain. The~     investigators will compare the use of 3 different possible medication combinations (ibuprofen~     alone, oral morphine alone, or combined ibuprofen and oral morphine) to determine which~     combination is the best at treating children's pain. The investigators also plan to verify~     the safety of using these different drugs to treat children's pain.~      The investigators strongly believe that children's pain should be optimally treated in the~     ED. Adequately relieving children's pain is crucial, as inadequate pain treatment can have~     both short and longterm effects on the child. It also generates unnecessary stress for both~     the child and their caregivers/parents. Given this knowledge, the investigators feel that~     their study has the potential to impact care provided in EDs, and improve pain management~     safely, for children.~   "
114793|NCT02064881|"~     The aim of this study is to evaluate the effect of metformin glycinate vs metformin~     hydrochloride on postprandial lipemia. 72 patients will be included, they will be randomized~     and assigned into one of the two treatment groups: metformin glycinate 1240 mg BID or~     metformin hydrochloride 1000 mg BID (36 patients per group). The patients will be followed~     for 4 months.~      Blood count, blood chemistry, liver profile, lipid profile, HbA1c, apolipoprotein B, oxidized~     LDL, fibroblast growth factor 21, leptin, adiponectin, C-reactive protein, free fatty acids,~     fibrinogen, Goodpasture Binding Protein (GPBP) and antioxidant activity of plasma will be~     measured at baseline and 4 months.~      Additionally, after a structured meal, the following parameters will be measured: glucose,~     insulin, triglycerides, apolipoprotein B and oxidized LDL. (baseline and 4 months).~     Throughout the study adverse events will be documented.~   "
114794|NCT02064868|"~     This is a multinational, multicenter, randomized, open-label study to confirm and expand the~     efficacy, safety and tolerability evidence of 48 hours intravenous infusion of serelaxin (30~     micrograms/kg/day) when added to Standard of Care (SoC) in patients admitted to hospital for~     Acute Heart Failure (AHF).~   "
114795|NCT02064855|"~     The purpose of this study is to evaluate fusion status and patient outcomes observed from use~     of the VESUVIUS Demineralized Fibers with the EVEREST Spinal System as compared to the~     literature reported outcomes of spinal fusion using autograft with posterior stabilization.~   "
114796|NCT02064842|"~     The purpose of the study is to investigate the safety, tolerability, and pharmacokinetics of~     TMC647055 in combination with ritonavir (Part 1); potential pharmacokinetic drug-drug~     interactions between TMC435 and the combination of TMC647055 with ritonavir; and to evaluate~     the short-term safety and tolerability when TMC435, TMC647055 and Ritonavir are~     co-administered (Part 2) in healthy Japanese participants.~   "
114797|NCT02064829|"~     The purpose of this study is to demonstrate bioequivalence of IG-001 versus nab-paclitaxel in~     female patients with metastatic or locally recurrent breast cancer. In addition, the study~     will compare the safety and tolerance of IG-001 and nab-paclitaxel during the bioequivalence~     2-period crossover portion of the study. The study will also evaluate the long-term safety of~     IG-001 over repeated cycles, up to 4 additional cycles of administration.~   "
114798|NCT02064816|"~     This is an open-label, multi-center, 12-week, randomized, controlled, parallel group, Phase 4~     study to assess whether the morning administration of interferon beta 1a (Rebif®) leads to a~     lower severity of flu-like symptoms (FLS) as compared to the evening administration, in~     subjects with relapsing multiple sclerosis (RMS).~   "
114799|NCT02064803|"~     The incidence of unresectable and obstructive gastric cancer patients ranges in the~     literature from 5 to 30 % . In such cases, gastro-entero anastomosis is traditionally~     performed and can improve the quality of life by relieving the symptoms of impaired oral~     intake without having a high surgical risk. Unfortunately, up to 25% of these patients may~     develop impaired gastric emptying syndrome. Gastric partitioning was originally described by~     Devine in 1925 as a method of antral exclusion and complete division of the stomach~     accompanied by a gastro-entero anastomosis in the proximal gastric pouch for the management~     of difficult duodenal ulcers. This procedure has been modified along the years and was~     adopted for the palliative treatment of gastric cancer. The advantages of the partitioning~     includes: better gastric emptying, avoidance of direct tumor invasion of the gastro-entero~     anastomosis, less contact between the ingested food and the tumor with less blood lost and~     improved survival. Retrospective not randomized studies have been published demonstrating the~     effectiveness of the procedure.~   "
114800|NCT02064790|"~     Although some studies show improvement of pain and associated effects of pain with off-label~     use of neuropathic agents for cervical or lumbar radiculopathy, there is limited published~     evidence so far. We propose to complete a year-long prospective, observational study as a~     pilot to recruit 400 patients within the year and follow their pain level, function, and QOL~     measures for 16 weeks to determine whether it is feasible to continue studying this group in~     the future. We expect that pain, function, and quality of life will be improved in the group~     of patients who are given neuropathic agents as an adjunct to other conservative treatments~     compared to the expected 65% of patients with similar symptoms who are treated conservatively~     without neuropathic agents. We do not expect a statistically significant difference between~     the two neuropathic agents.~      Since these drugs are currently used off-label, there is limited empirical evidence regarding~     which agent is more efficacious compared to the other, and since their use in treating~     radicular pain is based mostly on anecdotal evidence so far, prescription of one or the other~     of these agents has been based on likely compliance (medication needed twice a day, three~     times a day) or whether or not the patients' insurance will pay for one or the other. This~     study will be a first step to better assist practitioners in counselling their patients on~     use of these medications in radiculopathy, examining rates of discontinuation due to side~     effects and what effects these medications have on perceived pain, function and quality of~     life.~   "
114801|NCT02064777|"~     Our first aim is thus to investigate, retrospectively first and then prospectively, in de~     novo pediatric (living donor) liver recipients, the tacrolimus in vivo and in vitro~     metabolism and its variability with focus on pharmacokinetics, pharmacodynamics, and~     pharmacogenomics and its evolution according to the age and transplant delay. Our second aim~     is then to find better tacrolimus exposure markers for therapeutic drug monitoring (TDM) such~     as Area Under the time-concentration Curve (AUC) or intralymphocytic (PBMCs) tacrolimus~     concentration and a way to model and predict it without invasive tests in pediatric patients.~      The final objective should be then to implement these findings in a more individualized and~     comprehensive immunosuppression protocol and monitoring in order to maintain adequate and~     well-balanced immunosuppression (preventing graft rejection while avoiding acute and~     long-term side effects). This is particularly important for a pediatric population exposed~     throughout their life to immunosuppressants.~   "
114802|NCT02064764|"~     The purpose of this clinical study is to evaluate the feasibility of performing both renal~     nerve denervation and pulmonary vein isolation on the same patient with the intent of~     characterizing both safety and effectiveness in a paroxysmal and persistent atrial~     fibrillation population with hypertension. To assess safety, the study will measure the~     occurrence of a composite safety endpoint and, to assess effectiveness, the study will~     measure freedom of chronic treatment failure through a minimum of six months of follow-up.~   "
114803|NCT02064751|"~     The purpose of this study is to evaluate noninvasive hemodynamics with MultiPoint™ Pacing~     (MPP) and biventricular (BiV) pacing under various vector combinations and paced delays in~     patients receiving cardiac resynchronization therapy (CRT).~   "
114804|NCT02064738|"~     The purpose of this trial is to test the hypothesis that a treatment diet low in omega-6~     fatty acids and high in omega-3 fatty acids can cause improvement in asthma symptoms, nasal~     symptoms, and pulmonary function in patients with aspirin-exacerbated respiratory disease~     (AERD).~   "
114805|NCT02064725|"~     This is an open label, multi-center, single arm phase II study. The study will investigate~     the efficacy of sodium cridanimod in conjunction with progestin therapy in a population of~     patients with recurrent or persistent PrR-negative endometrial cancer.~   "
114806|NCT02064712|"~     The purpose of this study is to determine an optimal strategy to wean nasal continuous~     positive airway pressure (NCPAP) in preterm babies. The investigators hypothesize that babies~     that are taken off NCPAP at lower settings will need fewer total days on NCPAP than those~     babies taken off at higher settings.~   "
114807|NCT02064699|"~     Cytomegalovirus (CMV) infection was observed in over 30% of organ recipients with high~     morbidity. Moreover, no prophylaxis, 75% R + D-transplanted, 55%, R + D + and D-25% R +~     develop CMV. The number of available antiviral drugs is reduced and noticeable side effects~     (neutropenia, renal toxicity) lead to premature discontinuation of therapy or the use of~     reduced doses that promote non-response to treatment and the emergence of resistance. In case~     of neutropenia, there are more an increased risk of secondary rejection due to the reduction~     of immunosuppressive treatment rendered necessary by the haematological reached.~      Rational use of these molecules is necessary with essential today as the optimal duration of~     prophylaxis primary issues and the prophylaxis of recurrences in case of CMV infection~     reported in.~   "
114808|NCT02064686|"~     The goals : to develop and computerize equipment for measuring ITAE , compare the results~     with TAEP Itae study the possible relationship between different markers of inflammation:~     sputum eosinophils , FeNO , the ITAE and TAEP and see the influence spirometry or a~     bronchodilator in measuring the ITAE .~      It has designed a line of work studying the following aspects :~      1. Comparison with TAEP ITAE in a group of healthy and stable asthmatics 60 patients , 30~     asthma and 30 volunteers .~      Two . Study of the relationship between the number of eosinophils in sputum, FeNO , the ITAE~     and TAEP , 30 patients randomly FeNO , the ITAE and TAEP be measured.~      Three . ITAE measurement before and after the spirometry test , 20 patients , in stable phase~     will be measured before and after the ITAE spirometry .~      April . ITAE baseline measurement and after administration of 400 micrograms of salbutamol ,~     20 patients diagnosed with asthma , phase stable , they measure the ITAE before and fifteen~     minutes after administration of salbutamol .~      May . Measurement in patients Itae a bronchial provocation test with methacholine was~     performed , 20 patients were measured and baseline Itae after administration of methacholine~     .~      6. Measuring Itae in patients during an asthma exacerbation and stable phase , 20 patients~     during an exacerbation , the ITAE be measured. Already in clinically stable measurement is~     repeated.~   "
114809|NCT02064673|"~     This is a prospective study to determine if the adjuvant use of Curcumin improves~     recurrence-free survival.~   "
114859|NCT02064023|"~     This study is investigating whether insulin treatment with the insulin pump or with multiple~     daily injections (MDI) gives better outcomes for mother and baby in pregnant women with~     pregestational diabetes. Participants will be randomized to use either the insulin pump or~     MDI.~   "
114810|NCT02064660|"~     Myopia is widely one of the three commonly detected refractive errors. Myopia is usually~     managed by correction through glasses or contact lenses. Other alternative available include~     surgery, drugs and acupuncture. There are various therapeutic approaches and different points~     can be used in acupuncture treatment for myopia, such as auricular acupuncture, acupressure~     body acupuncture. However, the mechanism of acupuncture therapy for myopia is largely~     unknown. Furthermore, little information exists regarding the effects and safety of~     acupuncture for degenerative myopia in children.~      The investigators aimed to assess the overall effectiveness, safety of periocular acupressure~     for children with myopia~      The hypotheses of this study are as follows:~      Periocular acupressure is effective for myopia progression delay.~      The study aims to include 56 participants.~   "
114811|NCT02064647|"~     Continuous glucose monitoring (CGM) provides up to 288 blood glucose levels per day, updated~     every 5 minutes and displayed in real-time on the insulin pump, which can be used to enhance~     delivery of insulin through pump therapy. In addition this real-time CGM data includes trend~     arrows which indicate when the blood glucose is rapidly falling or rising thus enabling the~     pump user to make immediate adjustments in insulin delivery to prevent subsequent low or high~     blood sugars. The trend arrows are displayed when the blood glucose is rapidly falling or~     rising. For example, if the glucose is increasing by 1-2 mmol/L over 20 minutes, a single~     upward arrow alerts the pump wearer, who can then decide to give a bolus of insulin or~     increase the meal bolus. Should the glucose level be increasing at a rate greater than~     2mmol/L over 20 minutes, 2 upward arrows are displayed and the user could decide to give a~     larger bolus. The purpose of the bolus adjustment is to add insulin for the predicted rise in~     glucose to prevent or reduce subsequent hyperglycemia. Similarly, a decrease in the insulin~     bolus is advised if glucose levels are falling as evidenced by one or two downward arrows.~      However, effective strategies for adjusting insulin boluses based on CGM trend arrows are~     lacking. The JDRF CGM Study Group recommended that boluses be adjusted based on trend arrows~     using a standard 10-20% increase/decrease of the total original recommended bolus dose (10%~     for one arrow up or down, and 20% for two arrows up or down), with the original bolus dose~     calculated by the pump calculator (i.e. Bolus Wizard). However, the original recommended~     bolus dose is dependent on the amount of food to be consumed (grams of carbohydrate) and the~     current blood glucose (if above or below target range), as well as the amount of active~     insulin, and therefore increasing or decreasing the total recommended bolus by 10-20% may~     overcompensate for the trend arrows and result in postprandial hypoglycemia. Attempts to use~     the10/20% formula within CHEO's large pediatric pump/CGM population resulted in low~     acceptance and adherence by CGM users.~      The CGM TIME Trial Study Group develop an innovative tool for adjusting boluses for CGM trend~     arrows based on the patient's own insulin sensitivity factor (ISF). The Trend Arrow~     Adjustment Tool formula is: if CGM shows a single arrow up or down: adjust bolus by +/-~     (1.5/ISF) and for 2 arrows up or down +/- (3/ISF). Use of the Trend Arrow Adjustment Tool~     within the CGM TIME Trial appears to lead to more appropriate adjustment in bolus dosing, and~     more effective prevention of subsequent hyper- and hypoglycemia. Furthermore, this tool~     appears to have excellent uptake amongst the TIME Trial participants, with observations that~     there is continued usage of the tool throughout the 12 month study, and greater satisfaction~     with this component of CGM. However, the tool has not been systematically evaluated.~      The proposed study will evaluate the Trend Arrow Adjustment Tool, to determine its~     effectiveness in reducing postprandial hyper- and hypoglycemia, as well as parent,~     child/youth satisfaction, and ease of use of the tool based on self-report measures.~     Comparison will be made with the 10/20% bolus adjustment & also to no adjustments to meal~     boluses (i.e. ignoring CGM trend arrows). Should use of the Trend Arrow Adjustment Tool lead~     to more time spent within the target glucose range, this will have immediate clinical benefit~     for patients, including improved quality of life, and potentially a reduction in HbA1c and~     prevention of long-term complications.~   "
114812|NCT02064634|"~     This study investigates how gastrointestinal toxicity affects discontinuation of medication~     given to patients with osteoarthritis in routine clinical practice.~   "
114813|NCT02064621|"~     The purpose of this study is to evaluate a pharmacokinetic drug interaction and safety of~     Candesartan between free combination of Candesartan and Amlodipine and Candesartan~     monotherapy.~   "
114814|NCT02064608|"~     Patients with localised prostate cancer can be treated by radical prostatectomy (prostate~     gland removal surgery) or radiotherapy. Around 15% of men with prostate cancer are diagnosed~     with high risk disease meaning they are more likely to suffer treatment failure, disease~     progression and mortality. To date little progress has been made towards identifying~     effective treatment strategies that might delay or prevent disease recurrence in this patient~     population. Better identification of patients at high risk of relapse and improvements in~     therapy are therefore research priorities.~      A protein named Mammalian Target of Rapamycin (mTOR) is known to play an important role in~     the development of prostate cancer. mTOR forms two protein complexes (mTORC1 and mTORC2) and~     sends signals helping cancer cells to grow while controlling their energy use. Blocking the~     function of mTOR, with an inhibitor such as AZD2014, might shut down the supply of energy~     supply to tumour cells leading to reduced cell growth and potentially slowing the progression~     of the disease.~      The purpose of this study is to investigate the molecular pharmacology of AZD2014 treatment~     given to patients with prostate cancer prior to radical prostatectomy. The feasibility,~     safety and tolerability of a short course of AZD2014 will also be assessed.~   "
114815|NCT02064595|"~     The objective of this research is to prospectively evaluate a group of patients with shaft~     compound fracture of the tibia, treated with a biplanar external fixator or locked~     intramedullary reamed nail. The investigators evaluate the quality of life, bone healing and~     postoperative complications.~   "
114816|NCT02064582|"~     The study is being done to find out whether combining two FDA approved drugs along with~     radiation therapy for the treatment of high risk localized prostate cancer is safe and well~     tolerated.~   "
114817|NCT02064569|"~     The purpose of this study is to evaluate the safety and tolerability profile of ascending~     doses of GS010 in Leber Hereditary Optic Neuropathy (LHON) patients.~   "
114818|NCT02064556|"~     The purpose of this study is to evaluate a pharmacokinetic drug interaction and safety of~     Amlodipine between free combination of Amlodipine and Candesartan and Amlodipine monotherapy.~   "
114819|NCT02064543|"~     The project is a prospective trial comparing Zeno/GAITRite and APDM® in a cohort of persons~     living with parkinsonian disorders. Ambulatory patients with a parkinsonian syndrome and who~     are able to provide informed consent will participate in the assessments.~      Outcome variables include selected gait and balance parameters such as cadence, gait-cycle,~     stride-length, stride-velocity, turning duration, turning steps, postural sway and~     anticipatory postural control. These parameters will be measured by the portable inertial~     sensors developed by APDM® and the Zeno/GaitRite.~   "
114820|NCT02064530|"~     the aim of this study is evaluate postoperative analgesic effects of dexmedetomidine added to~     bupivacaine on TAP block in patients undergoing lower abdominal surgery.~   "
114821|NCT02064517|"~     Estimate if the technique of revascularisation pulpaire (with some hydroxide of calcium)~     allows to obtain a better forecast of preservation of the tooth without complication than the~     conventional technique with the creation of an apicale barrier in the MTA in 24 months.~   "
114822|NCT02064504|"~     GSK961081 is a novel bifunctional molecule that combines muscarinic antagonism and~     beta2-agonism in a single molecule and is in development for the treatment of chronic~     obstructive pulmonary disease (COPD). This is a randomised, open-label, six-way crossover,~     single dose study. This study evaluates the drug delivery and systemic pharmacokinetics of~     GSK961081 following concurrent administration of GSK961081 and fluticasone furoate via dry~     powder inhaler (DPI) in comparison to GSK961081 DISKUS. There will be six treatment periods~     and 7 days washout period in the study. Subjects will attend the unit in the morning for~     dosing and will be resident until 12 hours post administration. All subjects will receive six~     treatments.~   "
114823|NCT02064491|"~     The purpose of this study is to determine whether continuing erlotinib beyond disease~     progression in combination with chemotherapy is beneficial for NSCLC patients who have EGFR~     mutant disease or who have responded to EGFR TKI.~   "
114824|NCT02064478|"~     A bone anchored hearing system is used to improve hearing for patients with e.g.~     conductive/mixed hearing loss or single sided deafness.~      With this type of system, a titanium implant is installed in the temporal bone, where it~     osseointegrates, i.e. integrates with the bone. An abutment (also in titanium) is attached to~     the implants and penetrates the skin. The sound processor (hearing aid) is then connected to~     the abutment, and can be attached and removed by the patient via a snap-coupling. This type~     of system has been successfully implanted in more than 100.000 patients. Recently, a~     simplified surgical procedure, where no skin thinning around the abutment is made, was~     approved. The results after using this installation technique, here called soft tissue~     preservation, are the focus of this study.~      The objective of the study is to compare the outcomes after a surgical procedure with soft~     tissue preservation (test) and a surgery with soft tissue reduction (control) for placing~     Oticon Medical Ponto implants and abutments. The main hypothesis is that patient numbness~     around the implant is less in the test group compared to the control group.~   "
115871|NCT02050802|"~     The study is intended to demonstrate that macitentan does not have an effect on cardiac~     repolarization exceeding the threshold of regulatory concern after repeated administration of~     daily oral doses of 10 and 30 mg to healthy male and female subjects.~   "
114825|NCT02064465|"~     This is an open-label, randomised, parallel-group study to demonstrate the bioequivalence of~     lamotrigine 100mg in two different formulations, dispersible/chewable tablet and compressed~     tablet, in healthy subjects under fasting conditions. Subjects will be randomized in equal~     numbers to be dosed with either lamotrigine dispersible/chewable (Test) 100mg tablet or~     lamotrigine compressed (Reference) 100mg tablet. Pharmacokinetic blood sampling will be~     collected over 216 hours post dose. Safety (tolerability) will be observed up to 216 hours~     post dose. Safety assessments will include regular monitoring of vital signs, ECG's, adverse~     events (AEs) and safety laboratory tests. A follow-up visit is scheduled within 10-17 days~     post-dose.~   "
114826|NCT02064452|"~     This study will experimentally evaluate an internet-based version of the Triple P Positive~     Parenting Program, the Triple P Online System (TPOS), which presents the Triple P content in~     an interactive, video-enriched, and personalized format with 3-levels of flexible dosage, and~     will compare it against usual community services. Thirty pediatric clinics involving 100~     practitioners in 9 counties across western Washington will be recruited and randomized to~     receive (a) access for their patients to the Triple P Online System and training in how to~     effectively promote TPOS and advise parents on their children's behavior problems or (b)~     Usual Care Community-Waitlist Control, in which parents will be assisted with an appropriate~     referral for services in the community.~   "
114827|NCT02064439|"~     This is a multicenter, randomized, double-blind, event-driven, superiority study for~     efficacy.~      Patients with confirmed symptomatic DVT (Deep Vein Thrombosis) or PE (Pulmonary embolism) who~     completed 6 or 12 months of treatment of anticoagulation are eligible for this trial~   "
114828|NCT02064426|"~     Evaluate efficacy and safety up to 36 months of titrated dose treatment with BAY85-3934~     versus epoetin alfa/beta. Titration will be based on the subject's hemoglobin (Hb) response~     and tolerability of the prior dose. Planned doses include 15, 25, 50, 75, 100,and 150 mg once~     daily.~   "
114829|NCT02064413|"~     To evaluate the safety and successful placement rate of Essure Model ESS310 device and any~     factors that may influence the successful placement rate of this device.~   "
114830|NCT02064400|"~     Little is currently known as to the predictive value of ultrasound in guiding the decision to~     taper drug treatment in patients with stable rheumatoid arthritis, nor the influence that~     patients' views and opinions regarding their medications may have upon this. In this study,~     patients with stable rheumatoid arthritis will undergo a simple examination of their joints~     to look for any swelling or tenderness followed by an ultrasound scan to look for joint~     inflammation. Half of the patients will also complete an interview to assess their views and~     opinions of arthritis drug treatment. The study will be completed in a single patient visit -~     no invasive tests will be performed, and no changes to treatment will be made.~      This study is being conducted as part of a Masters degree from Newcastle University. The~     results of this study will be used to inform the feasibility of inclusion of ultrasound~     assessment within the design of a future PhD study to investigate potential markers of~     remission in patients with rheumatoid arthritis.~   "
114831|NCT02064387|"~     This study will assess the safety, pharmacokinetic (PK), pharmacodynamic (PD) and the~     therapeutic potential of GSK2857916 in subjects with multiple myeloma (MM) and lymphomas that~     express B cell maturation antigen (BCMA). The hypothesis is that GSK2857916 can be safely~     administered to subjects with MM and with BCMA positive malignancies at doses where target~     engagement can be demonstrated. This study will determine if adequate target engagement of~     BCMA receptors translates into clinical benefit for subjects with MM and BCMA positive~     lymphomas. The study will consists of two parts: a Part 1 dose escalation phase and a Part 2~     expansion phase for safety, tolerability, PK, PD, and clinical activity testing. The study~     will enroll a total of approximately 80-95 subjects with relapsed/refractory MM or~     BCMA-expressing hematologic malignancies. The maximum dose to be administered in this trial~     will not exceed 5 milligram/kilogram(mg/kg).~   "
114832|NCT02064374|"~     This study will be a phase 1, open label, parallel group, three period crossover study to~     evaluate the effect of dolutegravir (DTG) on the steady state pharmacokinetics of metformin~     and on the safety and tolerability of dolutegravir and metformin. Subjects will have a~     screening visit within 30 days prior to the first dose of study drug, three treatment~     periods, and a follow up visit 7-14 days after the last dose of study drug. Eligible subjects~     will be assigned to one of the two treatment cohorts. Subjects will receive metformin 500~     milligram (mg) after every 12 hours (q12h) for 5 days in Period 1; metformin 500 mg q12h plus~     dolutegravir 50 mg after every 24 hours (q24h) (Cohort 1) or 50 mg q12h (Cohort 2) for 7 days~     in Period 2; and metformin 500 mg q12h for 10 days in Period 3. There will be no washout~     periods between treatments. All doses of study drug will be taken following a meal. Safety~     evaluations will be collected during each period. Serial pharmacokinetic (PK) samples will be~     collected for metformin on the last day of each period and for dolutegravir on the last day~     of Period 2.~   "
114833|NCT02064361|"~     The purpose of this study is to determine the impact of high intensity,anaerobic exercise, in~     the form of cycling, on SCUBA diving. Outcomes are determined by the quantification and~     subtype of circulating microparticles, complete blood counts, and the quantification of~     venous gas emboli, measured via transthoracic echocardiography, in the cardiac cavities.~   "
114834|NCT02064348|"~     This trial is conducted in Europe. The aim of the trial is to evaluate the effect of~     semaglutide on cardiac repolarisation in healthy subjects.~   "
114835|NCT02064335|"~     In this project the investigators like to develop a methodology to stimulate more physical~     activity in inactive diabetic persons by an adapted physical activity program. An~     individually oriented and medically adapted exercise plan will be set up. Participants will~     be stimulated to be physically active in the long term, even when the coaching has been~     finished.~      In a randomized controlled trial the health effects of the coaching are studied in the short~     and long term. This trial, in addition to a process evaluation by all stakeholders, gives~     more information about the implementation of the project in Flanders.~   "
114836|NCT02064322|"~     The purpose of the SAIF study is to evaluate the SImmetry Sacroiliac Joint Fusion System for~     fusion and pain reduction of the SI joint.~   "
116269|NCT02045615|"~     The purpose of this study is to make clear how difficult it is to remove osteosynthesis~     materials afterwards, so surgeons will think twice before inserting intramedullary nails.~     Also it offers an alternative methode to remove the Wichita Fusion Nail after arthrodesis has~     become.~   "
114841|NCT02064257|"~     A research project funded by the Australian Childhood Foundation (ACF) will be conducted in~     Australian facilities of the ACF to evaluate the effectiveness of the Listening Project~     Protocol (LPP) in children with a trauma history. The LPP is designed as a neural exercise~     to reduce auditory hypersensitivities, to improve auditory processing of speech, and to~     improve behavioral state regulation. The LPP uses acoustic stimulation to exercise the neural~     regulation of the middle ear structures to rehabilitate and to normalize the acoustic~     transfer function of the middle ear structures. The current study is being conducted to~     evaluate efficacy and feasibility of the LPP and will use objective measures to evaluate~     changes in acoustic transfer function of the middle ears structures, auditory processing~     skills, physiological state regulation, and sensory symptoms.~   "
114842|NCT02064244|"~     Bedside ultrasonographic assessment of IVC size and IVC collapsibility index can be used to~     guide the management of patients with acute kidney injury with and without volume overload in~     the intensive care unit~   "
114843|NCT02064231|"~     To assess the functionality and safety of the test products and also assess the products~     ability to collect stool without interfering with the stoma.~   "
114844|NCT02064218|"~     First of all to evaluate the relationship between non-conventional biomarkers and essential~     hypertension; then to evaluate the effects of various anti-hypertensive drugs on blood~     pressure control and non-conventional biomarkers in naive hypertensive patients~   "
114845|NCT02064205|"~     Overweight and obesity are a global epidemic, which causes a rapid increase in the frequency~     of diabetes and cardiovascular diseases. Food ingredients that influence the mechanisms that~     regulate satiety may play a role in weight management. Suppression of appetite may reduce~     energy intake, which in return may lead to body weight reduction. This study aims to verify~     the appetite suppressive effect of polydextrose in comparison to a placebo in normal weight~     and overweight women.~   "
114846|NCT02064192|"~     The EUropean Comparative Effectiveness Research to assess the use of primary prophylacTic~     Implantable Cardioverter Defibrillators (EU-CERT-ICD) is a modular research project to study~     the effectiveness of prophylactic ICDs in a prospective study, a retrospective registry, and~     meta-analyses of existing evidence on the subject.~   "
114847|NCT02064179|"~     The use of heparin and aspirin for their respective anticoagulation and antiplatelet effects~     is routine in intensive care units around the country and world in children who have~     undergone surgery for congenital heart disease (CHD) who are at risk for thrombosis after~     repair. Most common protocols recommend heparin infusions after surgery with transition to~     oral aspirin when oral intake begins. Patients at risk for thrombosis after congenital heart~     surgery requiring long-term antiplatelet therapy include those undergoing shunt placement for~     single-ventricle palliation or establishment of pulmonary blood flow, valve replacements, or~     coronary artery manipulation. Post-operative thrombosis after congenital heart surgery is~     rare, but thrombosis can result in death. The routine use of aspirin in these patients is~     intended to prevent the potentially catastrophic consequences of thrombosis. However, there~     is no routine clinical assessment of the platelet inhibitory effect of aspirin; nor have~     there been any prospective studies to assess the effectiveness of aspirin's antiplatelet~     effect in children after congenital heart surgery. No data exists to suggest that the first~     dose of aspirin transition from heparin infusion is either sufficient or insufficient in its~     antiplatelet effect.~      In this study, the investigators will evaluate the effectiveness of the first aspirin dose in~     its antiplatelet effects after surgery for congenital heart disease. Degree of antiplatelet~     effect will be evaluated with thromboelastograph (TEG) and TEG-platelet mapping study~     analysis. Thromboelastography is a clinical laboratory method of assessing whole blood~     hemostasis and allows for assessment of clot formation, strength, and stability. TEG is most~     commonly used in patients at risk for bleeding or thrombosis and also to monitor antiplatelet~     therapies (such as aspirin).~      The investigators hypothesize: the first dose of aspirin transitioned from heparin infusion~     after congenital heart surgery is sufficient in its antiplatelet effect as tested by TEG and~     TEG-platelet mapping studies. Confirmation of the antiplatelet effect of aspirin will help~     support the current practice of empiric aspirin therapy to prevent post-operative thrombosis~     in children after congenital heart surgery.~   "
114848|NCT02064166|"~     Parkinson disease (PD) and multiple system atrophy (MSA) are progressive neurodegenerative~     disorders characterized by abnormal accumulation of α-synuclein. There is no effective~     treatment that can slow down the disease progression and both disorders are associated with~     severe cognitive decline. It was shown that intranasal insulin (INI) improves learning and~     memory in healthy and cognitively impaired non-diabetic adults.~      The proof-of-concept, randomized, placebo-controlled, cross-over pilot study ( NCT01206322)~     has shown that a single 40 international units dose of intranasal insulin improves~     visuospatial memory in diabetes and control subjects.~      This proposal includes randomized, double blinded, placebo-controlled trial of intranasal~     insulin (40 international units daily) in treatment of PD and MSA.~      The study will evaluate 22 patients with PD and 22 patients with MSA. Total duration of the~     study will be 2 years. The primary goal is to assess the efficacy of INI in treatment of~     cognitive abnormalities in both PD and MSA. The primary efficacy end point will be change of~     the cognitive scale ratings.~   "
114849|NCT02064153|"~     Hemodialysis (HD) is widely used treatment for end stage renal diseases (ESRD) patients. The~     chief aims of HD are solute and fluid removal. Decades of practice have improved HD care, but~     more can be done to improve morbidity and mortality. Enhancing toxin removal is an important~     consideration for improved patient outcomes. Also, decreasing the incidence of intra-dialytic~     hypotensive (IDH) episodes (dominant in Singapore patient cohort) can significantly reduce~     associated morbidities and mortality. A simple maneuver for clinicians is the dialysate~     temperature. Literature suggests that a lower dialysate temperature (35ºC) results in reduced~     hypotensive episodes by vasoconstriction. Conversely, higher dialysate temperature resulting~     in higher blood temperature decreases the peripheral resistance, leading to increased toxin~     removal, but may cause IDH episodes partly due to vasodilation. Optimal manipulation of the~     dialysate temperature is therefore primary handles to obtain the improved patient outcomes.~     In this study, the effect of dialysate temperature (cool vs. warm dialysate) on toxin removal~     will be studied. In both the interventions, outcome measure will be patient hemodynamic~     response and amount of toxins removed. The spent dialysate will be collected to study the~     quantum of toxin removed.~   "
114860|NCT02064010|"~     This Phase 2 study was designed to evaluate the efficacy and safety of SNC-102 in subjects~     with drug-induced Tardive Dyskinesia (TD). To ensure an adequate evaluation of SNC-102, a~     randomized, double-blind, parallel-group, placebo-controlled trial was designed. Two dosing~     levels of SNC-102 are employed to evaluate the proposed dosing range. A target enrollment of~     90 subjects with drug-induced TD will provide sufficient data to assess the efficacy and~     safety profiles of SNC-102 in the target population.~   "
114861|NCT02063997|"~     The purpose of this study is to determine whether arhalofenate is effective in preventing~     flares and reducing serum uric acid in gout patients.~   "
116270|NCT02045602|"~     The purpose of this study is to determine the safety and tolerability of VCN-01 either~     administered alone or in combination with Abraxane®/Gemcitabine, and to determine the~     recommended phase II dose of VCN-01 alone or in combination with Abraxane®/Gemcitabine.~   "
114850|NCT02064140|"~     Acute respiratory distress syndrome (ARDS) is characterized by acute bilateral pulmonary~     infiltrates and impairment of oxygen uptake. For example, pneumonia can cause the development~     of ARDS. Despite modern intensive care treatment, mortality in ARDS patients remains high~     (40%). Invasive mechanical ventilation (MV) is the mainstay of ARDS treatment. Controlled MV~     is the conventional ventilation strategy to ensure lung protective ventilation (low tidal~     volumes) and recovery of the lungs. However, among disadvantages of controlled MV are the~     development of respiratory muscle atrophy (due to disuse) and the need for high dose~     sedatives to prevent patient-ventilator asynchrony. The use of high doses of sedatives and~     respiratory muscle weakness are associated with increased morbidity, worse clinical outcomes~     and prolonged MV.~      Besides controlled MV, a patient can be ventilated with supported ventilation. Supported MV~     decreases the likelihood to develop muscle atrophy, improves oxygenation and hemodynamics,~     and lowers consumption of sedatives. However potential disadvantages of supported ventilation~     include generation of too high tidal volumes, especially in patients with high respiratory~     drive. A previous study in healthy subjects has shown that titration of neuromuscular~     blocking agent (NMBA) can decrease activity of inspiratory muscles, while maintaining~     adequate ventilation. It is hypothesized that low dose NMBA may enable supported MV with~     adequate tidal volumes, in patients with high respiratory drive.~   "
114851|NCT02064127|"~     The investigators aim to evaluate in a retrospective study the performance of the Swiss~     Emergency Triage Scale to identify at the door of the Emergency Department patients requiring~     emergent intervention.~   "
114852|NCT02064114|"~     Study hypothesis:~      Weight reduction in obese patients with atrial fibrillation. Obese patients benefit from an~     obesity treatment after atrial fibrillation ablation.~      Study design:~      A prospective randomized, open-label clinical trial.~   "
114853|NCT02064101|"~     Previous studies have shown how triggered electromyogram (EMG) pedicle screw stimulation can~     be used to effectively test correct pedicle screw placement in the lumbar and thoracic~     vertebrae. Most papers agree that if more than 6mA of current are needed to elicit a response~     the screw is correctly placed in the bone. If there is a response with less than 6mA there is~     a strong likelihood of a breach of the pedicle wall or invasion of the spinal canal.~     Typically this triggered EMG stimulation is done after all the screws have been placed with a~     ball-tipped probe and is paired with intraoperative fluoroscopy to ensure correct placement~     of the screws. Another method of testing the current for each screw is with a powered~     screwdriver, which can stimulate and give a reading as the surgeon places each screw. Both of~     these methods are currently used by surgeons, however the powered screwdriver has been found~     to be a faster method. The investigator's aim with this study is to compare these two methods~     of testing triggered EMG values. The investigators plan on doing this by testing each screw~     with both the ball-tipped probe and the powered screwdriver, in order to see if there are any~     statistically significant differences between the readings.~   "
114854|NCT02064088|"~     The transversus abdominis plane (TAP) block provide a local anesthesia drug diffusion between~     the transverse abdominis muscle and the internal oblique muscle. TAP block reaches the~     anterior rami of spinal nerves from T7 to L1 involved in the innervation of homolateral~     abdominal wall. The transversus abdominis plane block has shown promise for perioperative~     analgesia, but data on the optimal dose regimen are limited.Following previous research of~     optimal dose of local anesthesic solution, the investigators aim to evaluate if a volume~     effect would lead to a better diffusion of the local anesthesic solution to the overall~     nervous roots. The local anesthesia drug choosen is levobupivacaine with a unique posology of~     0,4 mg/kg (either 0,2 ml/kg of 0,2% levobupivacaine for small volume group or 0,4 ml/kg of~     0,1% levobupivacaine for high volume group).With the same dose of levobupivacaine, this~     study aims to assess the impact of volume effect on analgesia efficiency as well as the~     security as after ultrasound TAP block on one to five years' old children who undergo a~     peritoneal-vaginal duct surgery.~   "
114855|NCT02064075|"~     Purpose:~      - Vasospasm and secondary ischemia following subarachnoidal hemorrhage considerably affect~     the clinical outcome. The purpose of this study is to determine whether crystalloid (Lactated~     Ringer's solution) or colloid (hydroxyethyl starch) intravenous infusion is more effective in~     the treatment of subarachnoid hemorrhage (SAH)~      Treatment:~      - Patients are randomly divided into two groups. Depending on the blood pressure of the~     patients the members of the first group receive 15-50 ml/kg Lactated-Ringer's solution daily~     as part of the treatment, while the others 15 ml/kg Lactated-Ringer's and 15-50 ml/kg~     hydroxyethyl starch solution daily.~      Measurements:~        -  Neurological status of patients will be determined by the NIH Stoke Scale Score and the~          Glasgow Coma Scale (GCS) on a daily basis.~        -  The mid-term survival and quality of life are evaluated with Barthel Index and Glasgow~          Outcome Scale (GOS) 14 and 30 days following admission to our clinic.~      Hypothesis:~      -The prevalence of vasospasms, the mortality rate and the medium-term quality of life~     following subarachnoid hemorrhage is improved if patients are treated with intravenous~     colloid (hydroxyethyl starch) infusion compared to intravenous crystalloid infusion.~   "
114856|NCT02064062|"~     This study is looking at a new treatment, using the patient's own stem cells (the repair~     cells of the body), to see whether this can help reduce pain and promote healing of the~     Achilles tendon, without side effects.~   "
114857|NCT02064049|"~     The purpose of the study is to assess how feasible it is to treat and prevent the~     transmission of Hepatitis C in the prison setting to achieve substantial reductions in the~     incidence and prevalence of Hepatitis C.~      It is hypothesised that a rapid scale-up of Hepatitis C Virus (HCV) treatment with~     interferon-free Direct Acting Anti-virals (DAAs) in prison inmates will achieve a >50%~     reduction in the incidence of HCV infection over a two year period in the prison setting.~   "
114858|NCT02064036|"~     We hypothesize that Stereotactic Body Radiotherapy Boost (SBRT) as a boost to the prostate~     following whole pelvic intensity modulated radiotherapy (IMRT) can be delivered effectively~     and safely in a population of men with unfavorable intermediate and high risk localized~     prostate cancer.~      Our primary objective is to assess the feasibility and safety of a treatment strategy~     incorporating whole pelvic IMRT followed by an SBRT boost to the prostate with neoadjuvant,~     concurrent, and adjuvant androgen deprivation for a total of 28 months for men with~     unfavorable intermediate or high risk localized prostate cancer.~   "
114862|NCT02063984|"~     This study will continue research designed to improve treatment outcomes for adolescent~     substance use disorders by integrating neuroscience- and behaviorally-based treatments. In~     particular, this project will be the first to evaluate whether Working Memory Training can~     enhance cognitive function and reduce impulsive decision making to improve abstinence~     outcomes. In addition, an adaptive abstinence-based incentive program will be evaluated as a~     new method for intervening with those who do not respond to their first-line treatment.~   "
114863|NCT02063971|"~     The study will evaluate the tolerance and the efficacy on skin comfort of F#1048-082 soothing~     cream used just after injection procedure and also the tolerance and the efficacy of the~     F#841-020 anti-age cream on aging parameters compared to baseline and to the F#1374-002~     placebo cream (comparison within subjects - half face method) to identify additional benefits~     delivered by the product compared to a cosmetic procedure.~   "
114864|NCT02063958|"~     Study is designed to determine the maximum tolerated dose (MTD) of SNX-5422 when given in~     combination with everolimus.~   "
114865|NCT02063945|"~     Attention Deficit/Hyperactivity Disorder (ADHD) is one the most prevalent mental disorders~     among children and adolescents, with a prevalence of 5% in western culture. The basics of the~     disorder: inattentive and hyperactive/impulsive behaviors that manifest in a variety of~     settings causing a dysfunction in everyday life. ADHD can be subdivided into three sub-types:~     predominantly inattentive, predominantly hyperactive/impulsive or combined type. Common~     co-morbidities of ADHD are disruptive disorders; Oppositional defiant disorder (ODD) being~     the major one with about half of children with the combined sub-type ADHD and about a quarter~     of children with the predominantly inattentive also suffering from ODD. Conduct disorder is a~     co-morbidity for about a quarter of children with the combined sub-type ADHD. The~     co-occurrence of these disorders is thought to have a negative effect on the outcome of both~     of them.~      Methylphenidate (MPH), short or long acting, is the mainstay of medical treatment for ADHD~     patients, it's efficacy proven in a variety of studies. It should be noted that MPH has also~     been proven to have a beneficial effect on children with disruptive behaviors. For children~     with disruptive disorders Risperidone is the mainstay of medical treatment, and has been~     proven in clinical trials.~      To the best of their knowledge, a head to head study comparing these two drugs for the~     treatment of pediatric patients with ADHD and co-morbidity of disruptive disorders was never~     done before. The investigators aim is to examine the efficacy and tolerability of MPH vs.~     Risperidone in this population. In addition, the investigators will apply DSM5's cross~     cutting symptom measures scales is order to further define this unique subset of patients.~      Disruptive mood dysregulation disorder (DMDD) is a new diagnosis in the latest version of the~     diagnostic and statistical manual (DSM5). It's main features: sever recurrent temper~     outbursts that are inconsistent with developmental level and occur on average three times a~     week, the outbursts occur in at least two settings and the mood between outbursts is~     irritable or angry. This diagnosis is in the differential diagnosis of ADHD with disruptive~     disorders.~   "
114866|NCT02063932|"~     There might be a correlation between gastric mucosal microbiome and mucosal pattern~     visualized by confocal laser endomicroscope.~   "
114867|NCT02063919|"~     The purpose of this study is to determine whether an association between endomicroscopic~     pattern and colorectal mucosal microbiome exists.~   "
114868|NCT02063906|"~     Recently, the investigators face on the edges for treatment decision to decide adjuvant~     systemic treatment, especially for patients who show discordance between stage and tumor~     biology. The aim of this study was to compare the prognostic relevance of the TNM staging~     system and intrinsic subtype in breast cancer patients who received curative surgery.~   "
114869|NCT02063893|"~     Most studies of cancer stem cells (CSC) involve the inoculation of cells from human tumors~     into immunosuppressed mice, preventing an assessment on the immunologic interactions and~     effects of CSCs. In this study, the investigators examined the vaccination effects produced~     by CSC-enriched populations from histologically distinctmurine tumors after their inoculation~     into different syngeneic immunocompetent hosts. Enriched CSCs were immunogenic and more~     effective as an antigen source than unselected tumor cells in inducing protective antitumor~     immunity.Immune sera from CSC-vaccinated hosts contained high levels of IgG which bound to~     CSCs, resulting in CSC lysis in the presence of complement.CTLs generated from peripheral~     blood mononuclear cells or splenocytes harvested from CSC-vaccinated hosts were capable of~     killing CSCs in vitro. Mechanistic investigations established that CSC-primed antibodies and~     T cells were capable of selective targeting CSCs and conferring antitumor immunity.~   "
114870|NCT02063880|"~     Design: Randomized clinical trial involving hospitalized HIV-1 infected children. Children~     will be randomized to randomized to urgent (<48 hours) versus early antiretroviral therapy~     (7-14 days). This trial will be unblinded.~      Population: Hospitalized HIV-1 infected children who are antiretroviral therapy (ART) naïve ≤~     12 years of age.~      Sample size: 360 children will be randomized (180 per arm).~      Treatment: All infants will be treated with ART according to World Health Organization (WHO)~     and Kenyan national guidelines.~      Study duration: Enrollment into the study will occur over the course of 36-48 months and each~     infant will be routinely followed for a maximum of 6 months.~      Study site: Kenyan hospitals.~      Primary hypothesis:~      HIV-1 infected children hospitalized with severe co-infection either may be unsalvageable due~     to too far advanced immunosuppression/co-infection or may benefit from urgent ART.~      Secondary hypotheses:~      Urgent ART during an acute infection could potentially result in increased risk of immune~     reconstitution inflammatory syndrome (IRIS) or drug toxicities/interactions.~      Specific aims:~        1. To compare the 6 month all-cause mortality rate, incidence of immune reconstitution~          inflammatory syndrome (IRIS), and incidence of drug toxicity in HIV-1 infected children~          (≤ 12 years old) presenting to hospital with a serious infection randomized to urgent~          (<48 hours) versus early ART (7-14 days).~        2. To determine co-factors for mortality, IRIS, and drug toxicity. Potential cofactors will~          include: baseline weight-for-age, height-for-age, weight-for-height (Z-scores), CD4,~          HIV-1 RNA, type of co-infection, age, rate of viral load and CD4 change following ART,~          immune activation markers, pathogen and HIV-1 specific immune responses.~      Secondary aim: To determine etiologies of IRIS and to compare immune reconstitution to HIV,~     TB, EBV and CMV following ART overall and in each trial arm.~   "
114871|NCT02063867|"~     The ABATE Infection Project is a cluster randomized trial of hospitals to compare two quality~     improvement strategies to reduce multi-drug resistant organisms and healthcare-associated~     infections in non-critical care units. The two strategies to be evaluated are:~        -  Arm 1: Routine Care Routine policy for showering/bathing~        -  Arm 2: Decolonization Use of chlorhexidine as routine soap for showering or bed bathing~          for all patients Mupirocin x 5 days if MRSA+ by history, culture, or screen~      Note that enrolled subjects represents 53 individual HCA Hospitals (representing ~190~     non-critical care units) that have been randomized.~   "
114872|NCT02063854|"~     The present phase II/III, multicenter, randomized, double-blind, parallel group comparative~     study is designed to evaluate the efficacy and safety of once-monthly oral administration of~     NE-58095 delayed release (DR) tablets for 12 months in participants with involutional~     osteoporosis. For this study, participants receiving oral NE-58095 immediate release (IR) 2.5~     mg tablets once daily for 12 months are set as the control group.~   "
114873|NCT02063841|"~     ERCP is associated with radiation exposure to the endoscopist and staff, which may be~     significant at high volume programs despite the use of lead aprons. We hypothesize that~     draping of the fluoroscopy image intensifier may significantly reduce staff radiation~     exposure and help achieve implementation of the ALARA (As Low As Reasonably Achievable)~     principle.~   "
114874|NCT02063828|"~     The purpose of this research study is to compare the effects of music and different levels of~     device-guided breathing on anxiety and shortness of breath in lung cancer survivors.~   "
114878|NCT02063776|"~     Children on conventional haemodialysis (HD) die of heart disease. Also, they can be~     malnourished and short. Haemodiafiltration (HDF) is a newer type of dialysis that achieves~     better removal of toxins and excess fluid than HD. On HDF, adults have a longer survival and~     children show improved growth, but mechanisms are not understood.~      We will follow children in the UK and Europe to compare HDF and HD. We will monitor growth,~     heart and blood vessel scans, blood markers and quality of life. If the 3H~     (HDF-Hearts-Height) study shows reduced cardiovascular morbidity and better growth, HDF may~     be adopted as the preferred type of dialysis in children.~   "
114879|NCT02063763|"~     This study aims at analyzing the therapeutic activity of TPO-mimetics Eltrombopag and~     Romiplostim as bridge therapy for splenectomy in adult patients with primary immune~     thrombocytopenia.~   "
114880|NCT02063750|"~     Objective: We evaluated the effectiveness of strengthening exercises using the Swiss ball in~     patients with fibromyalgia (FM).~      Material and Method: Sixty FM patients were randomized into two groups: an intervention group~     (IG), in which patients performed muscle strength exercises using the Swiss ball, and a~     stretching group (SG), in which patients performed stretching exercises. All patients~     participated in 40-minute training sessions three times per week for 12 weeks. The IG~     performed the following eight strengthening exercises using a Swiss ball: lateral rise,~     simultaneous biceps curl, squat, two arms triceps extension, abdominal, one arm dumbbell row,~     reverse crucifix and crucifix. The SG performed exercises targeting the same muscle groups~     trained in IG. Outcome measures were as follows: visual analogue scale (VAS) for pain, 1~     repetition maximum test for muscle strength; fibromyalgia impact questionnaire (FIQ) to~     evaluate disease impact, and short form health survey (SF-36) to assess quality of life. All~     participants underwent an evaluation at baseline, at 6 weeks and at 12 weeks of training. The~     assessor was blind to patient allocation.~   "
114881|NCT02063737|"~     Aim 1: To determine if real-time assessments of perceived sleepiness and fatigue using~     text-messaging impacts an emergency medicine clinician's Attitudes, Perceived Norms,~     Self-Efficacy, Alertness Habits, Perceived Importance of Fatigue, Knowledge of~     Sleepiness/Fatigue, and Perceptions of Environmental Constraints regarding behaviors that can~     improve alertness during shift work.~      Aim 2: To determine if text-messaging emergency care workers fatigue-reduction strategies in~     real-time at the start and during shift work reduces worker perceived sleepiness and fatigue~     at the end of shift work.~   "
114882|NCT02063724|"~     The purpose of this study is to determine the safety and immunogenicity of HER-2 pulsed DC1~     vaccine in high risk HER-2 high and intermediate expression breast cancers. Participants will~     have HER-2 driven IBC at least Stage IIIA with N2 following chemotherapy with/without~     trastuzumab or recurrence exclusive of new primary tumor but rendered NED. Mammogram,~     laboratory studies, CT, and leukapheresis will be performed, in addition to vaccine~     administration.~   "
114883|NCT02063711|"~     Prenatal yoga has become a popular means of exercise during pregnancy.~   "
114884|NCT02063698|"~     This randomized pilot clinical trial studies whether auranofin will relieve pain following~     paclitaxel in patients who have previously experienced paclitaxel-induced pain. Auranofin is~     a drug given by mouth to treat other diseases such as rheumatoid arthritis, and is being~     studied to see if it will decrease pain following paclitaxel.~   "
114885|NCT02063685|"~     Recently, the availability of R has substantially changed therapeutic approach to FL~     patients, since its combination with chemotherapy has improved response rates, progression~     free survival (PFS) and overall survival (OS). Based on the results of recently completed~     randomized studies the standard treatment for patients with FL should consist of an initial~     therapy with R-CHOP combination followed by two-year maintenance with R. Although results of~     randomized trials confirmed that this approach results in an improved patients' outcome and~     made a step forward in the management of patients with FL, one important question that can be~     raised is if this approach is really needed for all patients with FL or if some of them could~     benefit from a reduced intensity treatment achieving the same results in terms of outcome and~     survival . This question is of particular interest for newly diagnosed patients for whom~     maintenance does not affect OS.~      More recent data demonstrated that the outcome of patients with FL can be further predicted~     by evaluating the quality of response to therapy studying minimal residual disease (MRD).~     This project addresses the objective of evaluating if combining clinical response assessed on~     FDG-PET scan and molecular response measured through MRD detection could permit to single out~     groups of patients at different risk of progression and to consequently modulate maintenance~     therapies, with the aim to provide clinicians a more rational use of the available diagnostic~     and therapeutic resources.~   "
114886|NCT02063672|"~     To assess the safety and efficacy of the Lutonix Drug Coated Balloon for treatment of~     femoropopliteal artery (SFA) in-stent restenosis (ISR).~   "
114887|NCT02063659|"~     The purpose of the study is to evaluate the effect of telotristat etiprate versus placebo on~     the incidence of treatment-emergent adverse events and on 5-hydroxyindoleacetic acid (5-HIAA)~     levels.~   "
114888|NCT02063646|"~     Several preliminary studies have shown that diet can have beneficial effects on cognitive~     decline. Among food shown to have such effects are some polyphenols from selected botanicals.~      Preclinical studies have concluded that polyphenols play a role in moderation of oxidative~     stress and inflammation, increased neuronal signaling, and improved metabolic function among~     other effects. Noteworthy, a positive and statistically significant association between the~     midlife level of polyphenol intake and cognitive function assessed 13 years later was found~     in a cohort of 2574 adults.~      Several mechanisms may be involved in these positive effects of food polyphenols on cognitive~     function in older adults: experimental studies suggest that polyphenols display~     neuroprotective effects, enhancement of the neuronal function, stimulation of brain flow and~     inducing neurogenesis, and might prevent age-related damage to the central nervous system~     through their antioxidant and anti-inflammatory activities.~      Based on these promising results, a food supplement from botanicals offering complementary~     polyphenol profile was developed. This food supplement is aimed to aid at maintenance of~     cognitive function in older adults.~   "
114913|NCT02063321|"~     The aim of the study is to find out prevalence of diabetic macular edema (DME) in patients~     with diabetes mellitus in Slovak Republic.The outcome of the project will be epidemiology~     survey, prevalence of wet form of Diabetic Macular Edema in relation to duration of diabetes,~     type of diabetes, treatment (insulin vs. OAD or combination) etc. and identification of~     prognostic factors leading to development of DME.~   "
114889|NCT02063633|"~     Technologic advances in the field of radiation oncology have made in possible to deliver a~     highly conformal and accurate radiation dose to a target tissue. Accompanying the rapid~     implementation of these novel techniques is often a reduction in the radiation margins, which~     reinforces the importance of accurate target delineation, and reduces the side effect of~     therapy.~      F-18 FDG PET/CT is widely used in oncology, including complete whole body staging, restaging~     and monitoring of tumor response in different types of cancers. As to non-oncology~     application, inflammation in almost any tissue will result in increased FDG accumulation.~     However, the normal tissue with sparing radiation may show subtle change, and would be~     difficult to be detected. FDG PET/CT was limited in the spatial resolution of 5 mm and low~     FDG-avid disease. To be evaluation of the interval change of metabolic response before and~     after radiotherapy of thoracic malignancies, we plan to initiate a prospective study trail~     the takes advantages of recent technical advances of technique in 4-dimensional PET/CT (4-D~     PET/CT) with respiratory gating system.~      Respiratory motion creates artifacts in PET and PET/CT images, and can alter diagnosis. The~     tumor edge would be blurred due to respiratory movement, and be underestimated the uptake~     value. Also, semi-quantitative measurement, standard uptake value (SUV), combined with~     parameters such as the lesion site and shape, which is commonly used to make the final~     assessment of disease would be mis-estimated.~      The study aims to investigate the correlation of 4-D PET/CT with respiratory gating methods~     and free breathing PET/CT when processing primary thoracic malignancy and normal tissue~     effect.~   "
114890|NCT02063620|"~     IVRA can be performed with many local anesthetics and adjuvant agents. In our study we~     planned to compare cardiac effects and ECG changes by IVRA with lidocaine and lidocaine plus~     ketamine.~   "
114891|NCT02063607|"~     This is an open label, dose ranging, phase1a/1b clinical trial to study the safety,~     Pharmacokinetics and Pharmacodynamics of Peglamda 60, 120, 180 and 240 mcg in healthy~     volunteers and antiviral activity of once weekly Peglamda administration in combination with~     daily Ribavirin in Hepatitis C naive patients up to 4 weeks period. The objective of the~     study to establish safety, PK/PD data on healthy subjects and preliminary efficacy and safety~     in Hepatitis C naive patients.~   "
114892|NCT02063594|"~     This is a randomized, double-blind, single dose, dose-escalation study to evaluate the~     safety, tolerability, and pharmacokinetics of NCTX (PEGylated Liposomal Iodixanol Injection)~     administered intravenously to healthy volunteers. In addition, computed tomography (CT) scans~     will be acquired to measure radiographic density in regions of interest (ROI) at times from~     3-5 hours and up to 72 hours following NCTX administration.~   "
114893|NCT02063581|"~     This Phase I, open-label, randomized, 2-period crossover study was designed to determine the~     relative bioavailability of ipatasertib administered as capsule and tablet formulations to~     healthy adult volunteers. Participants will be randomized to one of two treatment sequences~     to receive a single oral administration of ipatasertib in tablet or capsule formulation~     followed, after a washout period, by a single oral administration of ipatasertib in the~     second formulation. Pharmacokinetics will be assessed, and standard physical and clinical~     evaluations will be performed throughout the study. Time on study is expected to be 2 weeks.~   "
114894|NCT02063568|"~     The purpose of this study is to evaluate the differences in blood clotting seen in healthy~     patients given two different doses of oxytocin following cesarean delivery. The secondary~     objectives are to evaluate changes in blood pressure, rates of nausea and vomiting, and~     differences in blood loss with the two separate doses of oxytocin.~   "
114895|NCT02063555|"~     This is a Phase 1, randomized, controlled, double-blind, multiple-dose, dose-ranging study of~     DAR 901, (an inactivated whole cell mycobacterial vaccine) to be conducted in HIV negative~     and HIV positive adults previously vaccinated with BCG. The goals of the trial are to~     determine the safety, tolerability, and immunogenicity of multiple doses of the vaccine at~     different dose levels, ranging from 0.1 to 1 mg.~   "
114896|NCT02063542|"~     Previous study demonstrated that the condition of central cholinergic nerve is important for~     the postoperative cognitive dysfunction. In present study investigators hypothesized that the~     acetylcholine concentration in the cerebral spinal fluid is associated to the postoperative~     cognitive changes in aged patients undergoing osteopathic surgery.~   "
114897|NCT02063529|"~     PURPOSE:~      A primary aim of phase II FOCULM study is to explore whether cetuximab in combination with~     FOLFOXIRI as first treatment could improve surgical conversion in patients with KRAS/NRAS~     wild-type, unresectable liver - only metastases of colorectal cancer. The first secondary aim~     is to evaluate the safety and tolerability of the chemotherapy of FOLFOXIRI plus Cetuximab~     targeted therapy regimen in this patient population.~      Secondary aims include determination of objective response rate, progression free survival,~     quality of life and time to recurrence for patients undergoing complete resection and/or~     ablation of liver.~   "
114898|NCT02063516|"~     To compare insertion characteristics of 2 different supraglottic devices (Guardian LMA and~     Proseal LMA) and to observe any associated complications.~   "
114899|NCT02063503|"~     There is a consensus that exercise therapy should be used as a therapy approach in CLBP but~     little consensus has been reached about the preferential type of therapy. There occurs to be~     a wash out effect because of the heterogeneous character of CLBP patients. As a result, no~     effect can be demonstrated for the entire sample. This is why one should consider creating~     subgroups based on prognostic indicators.~      Objectives for this trial is to possibly identify prognostic indicators for treatment~     response to three forms of exercise therapy for patients with nonspecific chronic low back~     pain (CLBP).~      The study design is a multicenter cohort design. Patients with nonspecific low back pain of~     more than three months duration are recruited in two different hospitals (Antwerp University~     Hospital and Sint Vincentius Hospital). After examination patients are assigned to one of~     three intervention groups: motor control therapy, isometric training therapy and a~     combination therapy. All patients will undergo eighteen treatment sessions during nine weeks.~     Measurements will be taken at baseline and after nine weeks of treatment.~      The primary outcome used is the Modified Oswestry Disability Questionnaire (MDQ). For each~     type of exercise therapy prognostic indicators will be investigated.~      Never before a multi-arm design was performed for the identification of prognostic indicators~     for exercise therapy in patients with nonspecific CLBP.~   "
114901|NCT02063477|"~     The objective of the study is to evaluate the effect of consumption of a food supplement rich~     in procyanidins extracted from the bark of French pine, Oligopin®, on blood pressure of~     people with mild / moderate degree of hypertension. Furthermore, the effect Oligopin®~     consumption on markers involved in the development of hypertension, and endothelial function~     in key enzymes that regulate blood pressure, inflammation and oxidation are considered. Also,~     try to advance the understanding of the molecular mechanisms that regulate blood pressure.~   "
114902|NCT02063464|"~     Background:~        -  Monocytes are a type of white blood cell found in human blood. They help the immune~          system. Researchers have found that monocytes taken from the blood of healthy people can~          kill tumor cells. Now they want to know if monocytes taken from the blood of people with~          ovarian cancer can kill tumor cells.~        -  In addition, native host anti-tumor cell mediated immune mechanisms may play a role in~          clinical outcome of epithelial ovarian cancer; data indicate that the presence of~          intra-tumoral CD3+ T-cells was shown to prognosticate improved outcome in advanced~          ovarian cancer. Furthermore, non-cellular components in the blood, such as exosomes, may~          influence outcome.~      Objective:~      - To see if monocytes taken from the blood of people with ovarian cancer can kill tumor~     cells.~      Eligibility:~      - Women 18 years and older with ovarian cancer.~      Design:~        -  Participants will be screened with:~        -  Medical history and physical exam.~        -  Blood tests.~        -  CT scan of the chest, abdomen, and pelvis and/or an MRI. For these scans, they will lie~          in a machine that takes pictures of their body.~        -  A small amount of blood (two tubes) will be collected by needle during one visit.~   "
114903|NCT02063451|"~     Obesity has reached epidemic levels in the United States, and is on the rise in many~     industrialized nations. The rate of recidivism for long-term weight loss is substantial and~     presents a critical problem given the importance of obesity as a modifiable risk factor for~     diseases like type 2 diabetes. Further, the comorbidity of depression with diseases like~     obesity, type 2 diabetes, and cardiovascular disease suggest that there may be an underlying~     shared biology for diseases of metabolic dysfunction and emotional dysregulation. The shared~     biology of these diseases may actually promote the precipitation and exacerbation of comorbid~     conditions, impacting the success of treatment. Endogenous opioid systems regulate a number~     of physiological and psychological processes including mood, energy management, and reward.~     Endogenous opioid µ-receptor-mediated reward processing is thought to be involved both in the~     short-term control of eating and hedonic food consumption, based on data in animal models.~     The present proposal will examine the function of the µ-opioid receptor (MOR) system in lean~     and obese human volunteers following an overnight fast and the change in µ-opioid receptor~     occupancy (i.e., endogenous opioid release) following the consumption of a standardized meal~     using PET imaging with the µ-selective radiotracer [11C]carfentanil. The obese individuals~     will be retested in the fasting and fed state following a 15% weight loss with a Very Low~     Calorie Diet. Further, the investigators will evaluate the function of the MOR system within~     the context of the individual's metabolic and psychological profile including aspects of mood~     and inhibitory control. This information will provide the neurobiological bases to develop~     novel avenues of intervention based on individual variations in central mechanisms associated~     with motivational systems and appetite and their potential role in weight regain.~      The investigators hypothesize that overeating in chronically obese individuals will be~     associated with a dysregulation of MOR system function, manifested by reductions in baseline~     MOR availability (binding potential, BP) in limbic and reward circuitry, and lower release of~     endogenous opioids after a standard meal, compared to lean volunteers. The latter is observed~     as acute reductions in the BP measure after meal ingestion.~   "
114904|NCT02063438|"~     The purpose of this study is to examine pain associated with thoracotomy (incision made~     during surgery to obtain access to your thoracic cavity) and how the closure technique may~     influence postoperative pain. Two types of routinely selected thoracotomy closure techniques~     will be examined; pericostal and intracostal sutures. The investigators hypothesize that~     intracostal sutures will result in less postoperative and chronic pain as a result of less~     compression of the intercostal nerve.~   "
114905|NCT02063425|"~     The objective of this study is to better characterize the mechanisms of action of fluoxetine~     in motor recovery and more specifically to identify the neurophysiological substrate~     underlying fluoxetine-induced motor recovery in stroke.~      In this study, the investigators propose to use transcranial magnetic stimulation (TMS) to~     assess the effect of a chronic treatment of fluoxetine on corticospinal excitability and~     integrity.~   "
114906|NCT02063412|"~     The objective of this study is to compare the possible time savings from reduction of nursing~     and pharmacy time to manage AEGC patients using capecitabine-based regimens versus~     traditional intravenous chemotherapy in the Hong Kong public hospital setting.~   "
114907|NCT02063399|"~     The purpose of this study is to determine if the screening of nasopharyngeal carcinoma using~     plasma Epstein-Barr virus DNA analysis would result in the down-staging of the NPC cases in~     asymptomatic individuals.~   "
114908|NCT02063386|"~     To assess the absorption, distribution, metabolism and excretion of a single dose of 14C~     labelled AZD1722 in order to define the rates and routes of elimination of AZD1722 and if~     formed, metabolites.~   "
114909|NCT02063373|"~     Treatment: five intro-articular Hyaluronic Acid injection~      Assessment has two parts, that are as follow:~        1. Postural stability and risk of fall assessment using Biodex stability index and Timed~          up and Go test~        2. Gait and stair climbing assessment using Vicon motion capture system synchronized with~          four force plates.~      For knee OA subjects, assessment was done in week one or before injection; and for healthy~     controls one assessment was performed.~   "
114910|NCT02063360|"~     The purpose of this study is to determine if there is an interaction in healthy subjects~     taking BMS-663068 with Darunavir/Ritonavir and/or Etravirine.~   "
114911|NCT02063347|"~     Both clinical and experimental studies demonstrate the importance of the pre-existing, ie~     innate collateral supply in different vascular regions. Furthermore, pathophysiological~     considerations and experimental data imply an important role for the association of~     collateral function between different vascular regions.~      STUDY HYPOTHESES 1. In the absence of atherosclerotic stenoses, there is a direct association~     between the collateral function in the coronary, renal and peripheral circulation. 2. The~     increase in plasma renin in response to a unilateral main renal artery balloon occlusion is~     inversely related to its functional collateral supply. 3. The decrease in renal vein oxygen~     saturation in response to a unilateral main renal artery occlusion is inversely related to~     its functional collateral supply.~   "
114912|NCT02063334|"~     The purpose of the study is to investigate whether a high-dose vitamin D3 oral bolus (2000~     micrograms) produces marked vitamin D receptor target gene expression response and whether~     there is large inter-individual variation.~   "
114914|NCT02063308|"~     By doing this study, researchers hope to learn how much oxaloacetate (OAA) ends up in the~     blood after OAA capsules are swallowed, and to assess whether persons with Alzheimer's~     disease who take OAA for one month have any side-effects.~   "
114917|NCT02063269|"~     Butyrylcholinesterase (BuChE) activity is increasing in Alzheimer Disease (AD) process (Lane~     et al., 2006). BuChE wild type has stronger butyrylcholine esterase activity than BuChE K~     variant allele and this strong activity can affect AD brain negatively by choline depletion.~     Rivastigmine has unique dual action - acetylcholine esterase inhibition and butyrylcholine~     esterase inhibition. Therefore, rivastigmine can lower serum butyrylcholine esterase activity~     and delay functional decrease of Fluorodeoxyglucose positron emission tomography (FDG PET)~     images in AD patients with BuChE wild type allele by strong BuChE inhibition.~      It suggests that rivastigmine can affect brain function differently by BuChE genotype in AD.~     Therefore, we will try to find the different changes of serum butyrylcholine esterase~     activity by ELISA and functional and structural changes of brain between BuChE wild type and~     K-variant type by FDG PET and MRI pre and post images after 12 month use of rivastigmine.~        1. Primary objective:~             1. the mean changes of Standardized Uptake Values (SUVmean) in PET imaging~             2. the mean changes of serum BuChE activity between BuChE wild type and K-variant~               type.~        2. Secondary objectives:~             1. the mean changes of cortical thickness in brain MRI~             2. the cognitive changes in Alzheimer's Disease Assessment Scale-cognitive subscale~               (ADAS-cog)~             3. the cognitive changes in Mini-Mental State Exam (MMSE)~             4. the daily function changes by Alzheimer's Disease Cooperative Study - Activities of~               Daily Living (ADCS-ADL)~             5. the behavioural changes by Caregiver-Administered Neuropsychiatric Inventory (NPI)~             6. the disease severity changes by Clinical Dementia Rating Scale-Sum of Boxes~               (CDR-SB) between BuChE wild type and K-variant type.~   "
114918|NCT02063256|"~     Setting. Outpatient fertility clinic.~      Aim. Investigate if a modification in nutritional habits may improve in the short term the~     qualities of human sperm, testing two hypothesis:~      i) that adding to the diet a natural whole food rich in polyunsaturated fatty acids (PUFA)~      OR~      ii) that reducing the intake of saturated fatty acids and increasing the consumption of PUFA~     may affect beneficially sperm parameters.~      Population. N. 100 hypofertile male subjects attending a fertility clinic.~      Type of study. Interventional study. No drugs or pharmacologic supplementation will be~     required nor allowed.~      Two different type of intervention are scheduled:~        -  Supplementation to western style diet with nuts, naturally rich in PUFA~        -  Diet modification increasing intake of PUFA-rich foods and cutting the consumption of~          food rich in saturated fats.~      Protocol~        -  Baseline visit and recruiting.~        -  Informed consent~        -  Randomized allocation to treatment group in a 1: 1 manner~      Blinding. Investigators deputed to sperm analysis and statistician are blinded as to type of~     intervention.~      Phases:~        -  i) basal~        -  ii) after 15 weeks That interval is chosen because encompasses an entire spermatogenesis~          cycle.~      Outcomes. Primary~        -  sperm count, concentration,morphology and mobility.~      Secondary:~        -  serum folate assay,~        -  plasma PUFA (ALA, EPA, DHA) assay,~        -  body weight and BMI variation~      Statistics. A comparison for all sperm parameters (count,concentration,morphologic~     abnormalities, mobility) will be carried out by an analysis within groups and within patient.~   "
114919|NCT02063243|"~     This prospective evaluation studies the effectiveness of Intralesional (IL) cryotherapy with~     a argon gas based device in treating keloids and hypertrophic scars in population consisting~     of all Fitzpatrick skin type patients~   "
114920|NCT02063230|"~     A study to assess the pharmacokinetics, safety and tolerability of Selumetinib (AZD6244,~     ARRY-142886) in patients with hepatic impairment and healthy subjects.~   "
114921|NCT02063217|"~     The purpose of this study is to change the concentration of amyloid-beta in human~     cerebrospinal fluid (CSF) through modulation of the sleep-wake cycle.~   "
114922|NCT02063204|"~     A study to assess the pharmacokinetics, safety and tolerability of Selumetinib (AZD6244,~     ARRY-142886) in subjects with renal impairment and healthy subjects~   "
114923|NCT02063191|"~     This is a single center, non-randomized, unblinded study of patients who are followed at~     Essentia Health - St. Mary's Medical Center and who are referred for a clinically indicated~     diagnostic electrophysiology (EP) study with or without ablation. During the procedure,~     events of atrial fibrillation, sinus rhythm and bundle branch block that may occur during the~     course of the case will be saved electronically and analyzed offline. The stored data will be~     evaluated off-line for changes in activation timing of the near and far field ventricular~     signals of the stored events.~      This proof-of-concept study will attempt to assess whether atrial fibrillation, or bundle~     branch block can change activation timing compared to baseline sinus rhythm. If no~     significant activation change is seen, then this finding can be used as a basis to~     distinguish ventricular tachycardia from atrial fibrillation in future rhythm discrimination~     methods.~   "
114924|NCT02063178|"~     Purpose: This study aims to take the procedural and research-based lessons learned from a~     pilot weight loss intervention (IRB # 13-02563-XP), conducted by The University of Tennessee~     Health Science Center in 2013, and apply them to the current study of 204 active duty~     military personnel. The pilot study translated and tailored the Look Ahead weight loss~     intervention to an overweight/obese active duty U.S. Air Force population, while~     accommodating the lifestyle and environment that is unique to military members and evaluate~     materials and procedures used.~      Rationale: Being overweight is now by far the leading medical reason for rejection in the~     military. Unfortunately, the impact of weight problems on the military does not stop with~     those turned away from military service. From 1998 to 2008, the Armed Forces Health~     Surveillance Center reported the percent of active military members who experienced medical~     encounters for overweight or obesity significantly increased. The estimated total days of~     work lost from absenteeism associated with active-duty personnel who are overweight or obese~     was 658,000. Using Department of Defense (DOD) estimates of average daily based, it was~     estimated that overweight and obesity costs the DOD $103 million dollars in health care costs~     annually. Note this estimate is for active duty personnel only. Furthermore, obesity is a~     major cause for the discharge of uniformed personnel.~      The current study is inspired by the successful Look Ahead trial, a behavioral science~     obesity intervention treatment program that included: a collaborative approach, education,~     behavioral support, and motivational interviewing. The unique nature of this weight reduction~     study is significant. To our knowledge, there had not been a successful translation of a~     highly efficacious obesity treatment in the military until The University of Tennessee Health~     Science Center implemented a pilot version of the Fit Blue program for active duty U.S. Air~     Force members in 2013. Following a successful pilot and extant results from the Look Ahead~     trial, Investigators expect success during the full scale Fit Blue study.~   "
114925|NCT02063165|"~     The purpose of this study is to understand the role of a dietary oil to alter chronic disease~     risk factors in women who are at risk for heart disease and/or diabetes. The investigator's~     previous study showed that safflower oil reduced trunk fat mass in women with diabetes. The~     investigators believe safflower oil can also attenuate criteria of metabolic syndrome through~     reduction in trunk fat mass.~   "
114926|NCT02063152|"~     This study aimed to evaluate the subsequent cancer risks, including gynecological cancers and~     malignancies at other sites, after the detection of screening positives and the diagnosis for~     primary cervical cancer.~   "
114927|NCT02063139|"~     Aim of the study is to investigate the short-term growth in children with asthma aged 5-11~     years in treatment with fluticasone propionate / formoterol spray (flutiform®) 200/20~     micrograms per day~   "
114928|NCT02063126|"~     The main objective is evaluate to safety and efficacy of oral Reconnect ® (food~     supplementation composed by Coenzyme Q10, NADH, phosphoserine y vitamin C) on the maximum HR~     during an exercise test in CFS~   "
114929|NCT02063113|"~     The aim of this study is to determine whether the presence of vulnerability detected by~     geriatricians is associated with treatment discontinuation in older patient. During the~     comprehensive geriatric assessment realized before the decision-treatment, the following data~     are recorded and their impact in the therapeutic changes will also be analysed: comorbidity,~     age, depression, functional status, the cognitive impairment and malnutrition.~   "
114930|NCT02063100|"~     -Evaluate the efficacy and safety of Shenyankangfu Tablets to control the proteinuria of~     patients with primary glomerulonephritis compare with Losartan potassium.~   "
114931|NCT02063087|"~     The investigators will test the impact of a decision aid, Head CT Choice, to determine if its~     use improves parents' knowledge and engagement in decision making and safely decreases~     healthcare utilization in children presenting to the emergency department with blunt head~     trauma.~   "
114932|NCT02063074|"~     The purpose of this proposal is to determine the long-terms effects of hormone and lifestyle~     factors on bone health in young women over a 20-year time period. It is our primary~     hypothesis that premenopausal women with irregular periods or endocrine issues related to~     estrogen will have significantly poorer low back and hip bone health when compared to~     regularly menstruating women. It is our secondary hypothesis that long-term assessment of~     changes in endocrine function and lifestyle behaviors will assist in establishing risk~     factors for osteoporosis in young women. This study will include 1000 premenopausal women.~     The women will participate in the collection of a blood sample, bone scan, body fat measures,~     and lifestyle questionnaires. In addition, we hope to use this initial study to develop a~     group of women to follow throughout menopause, with additional visits occurring every 5 years~     over the course of their life.~   "
114933|NCT02063061|"~     The purpose of this study is to determine whether extracorporeal shock wave therapy (ESWT) is~     an effective treatment for erectile dysfunction.~   "
114934|NCT02063048|"~     The purpose of this study is to compare the effectiveness of text message-based support to~     usual care at promoting weight loss in patients with pre-diabetes.~   "
114935|NCT02063035|"~     Hypothesis: Topical application of Tranexamic acid into the surgical wound during spine~     surgery will decrease the overall blood loss post-operatively. This reduction in blood loss~     will reduce the need for transfusion. In addition it will also significantly reduce the cost~     of the surgical procedure.~      Specific Aim 1: The goal of this study is to quantitatively assess whether topical~     application of tranexamic acid placed into the surgical wound during lumbar spine surgery~     will decrease post-operative blood loss, thus lowering the need for blood transfusions. By~     reducing the number of transfusions participants can avoid the well-known complications~     associated with them. The investigators do not plan on measuring serum tranexamic acid~     levels.~      Several meta-analyses and level I studies have shown that intravenous (IV) administration of~     tranexamic acid is effective in reducing postoperative blood loss and the need for~     transfusion.~   "
114936|NCT02063022|"~     Controlled, randomized phase III study, with the intent of optimizing the treatment of not~     metastatic Ewing Sarcoma. The patients will be randomized into 2 arms: standard treatment vs~     intensive treatment. Both arms will receive an induction treatment followed by surgery~     (wherever is possible) and/or radiotherapy. The maintenance treatment will be different on~     the basis of the response to the induction treatment (good or poor)~   "
114937|NCT02063009|"~     Perioperative hemodynamic optimization requires monitoring adapted to the risks of the~     surgery and the patient. We currently use a local hemodynamic protocol based on the data of~     the literature. According to this protocol, specific patients may require cardiac index and~     central venous oxygen saturation monitoring. We chose to monitor the cardiac index (CI) with~     the transpulmonary thermodilution technique (TPTD) (PiCCO, Pulsion Medical System, Munich,~     Germany). The technique is based on the injection of a cooled bolus of saline into a central~     vein with a central venous catheter (CVC). The variation of temperature is measured with an~     arterial femoral catheter and allows the assessment of the cardiac output according to~     Stewart-Hamilton's theory. Many studies showed the reliability of this technique.~      In our institute, most of the patients are fitted with a port for chemotherapy or parenteral~     nutrition. When PiCCO monitoring is necessary, a central venous catheter is inserted on the~     opposite side of the permanent implantable venous port. Indeed, insertion of the CVC can be~     more difficult because of the port. It may be interesting to use the port for TPTD in order~     to avoid the insertion of a new CVC. This would be possible only if the measurement of CI by~     the port was as reliable as the classical measurement with a CVC.~   "
114938|NCT02062996|"~     Oxymetazoline is an α-adrenergic agonist that is commonly used as a topical sympathomimetic~     agent in over-the-counter decongestant sprays. It is used extensively at Nationwide~     Children's Hospital for surgical procedures to produce vasoconstriction and reduce bleeding.~     Although there is generally limited vascular absorption, when administered in larger doses,~     uptake of oxymetazoline can lead to significant systemic hemodynamic effects. The NCH~     anesthesia department recently reported a case of oxymetazoline induced postoperative~     hypertension in a three-year-old child following inferior turbinate reduction and~     adenoidectomy. Current practice at NCH is to soak pledgets with full strength oxymetazoline~     and insert a varying number of pledgets during surgical procedures or instill oxymetazoline~     drops into the nose prior to nasotracheal intubation. There is no pediatric data regarding~     the method of administration and the absorption of oxymetazoline or the dose-response~     relationship of oxymetazoline serum levels on blood pressure and heart rate. These studies~     would be the first to determine safe and appropriate doses of oxymetazoline in the pediatric~     population.~   "
114939|NCT02062983|"~     Early identification of patients at risk for cardiotoxicity represent a primary goal for~     cardiologist and oncologist~      From all adjuvant trials echocardiography is ideal for evaluating Left Ventricular function~     though its operator dependent. The use of other technique such as endomyocardial biopsy, is~     troublesome in clinical practice~      Cardiac magnetic resonance imaging (MRI) have greater reproducibility in evaluating left~     ventricular ejection fraction (LVEF). This technique provides morphological, functional,~     perfusion, and viability information in one assessment. It is expensive and time consuming~     but id the diagnostic method of choice for patients with technically limited images from ECG~     and in patients with discordant information that is clinically significant from prior tests~   "
114940|NCT02062970|"~     Septic shock is a clinical syndrome occurring in 10 to 20% of patients admitted in ICV.~     Mortality associated to septic shock varies from 30 to 50%. It follows a systemic response of~     the organism to a severe infection, associated with a circulatory failure marker by an~     arterial hypotension and a vascular hyperactivity to vasoconstrictor agents.~      The mechanisms involved on one hand an activation of white blood cells inflammatory system~     and the vascular inflammatory system; and on the other hand on imbalance in hemostatis~     characterized by an activation of the coagulation and an inappropriate fibrinolysis leading~     to a disruption of microcirculation in the context of a disseminated intravascular~     coagulation (DIVC).~      This inflammatory and thrombotic cellular activation is strongly associated with the~     phenomenon of vesiculation; leading to the production of cellular microparticles (MP) by~     blood cells and vascular cells.~      MP are membranous vesicles, resulting in the reassortment of membrane phospholides in~     response to an activation of cellular apoptosis. They have been initially described as new~     actors of hemostatis. Indeed, the expression of phospholipid serine and tissular factor (TF)~     confer them a procoagulating activity, which increases in patients undergoing septic shock.~      The finding of a fibriniolytic activity of the cellular MP suggests the existence of~     compensating mechanisms with a procoagulating activity. This confers to MP a key-role in the~     control of the coagulolytic balance.~      Our recent researches suggest that endothelial and white blood cells MP produce in vivo~     plasmin.~      They carry into the main circulation a fibrinolytic activity which is partially beyond the~     physiological inhibitors activity (PAI-1, x 2 antiplasmin). Preliminary findings show that~     this ability of plasmin generation is important in patients affected with septic shock.~      Our hypothesis is that an increase in plasmin generation by MP compensates the risk of~     occurrence of microthrombosis, modulating therefore the vital prognosis of patients with~     septic shock.~      The coagulolytic balance of MP, which is resulting of their own procoagulating and~     fibrinolytic activities could claim the status of new pronostic marker relevant in patients~     with septic shock.~   "
114941|NCT02062957|"~     1. recruit 50 patients with atrial fibrillation and 30 controls~        2. endovascular function assessment with Peripheral Arterial Tonometry (PAT)~        3. follow up the occurence of AF~   "
114942|NCT02062944|"~     The significance of this clinical trial lies in its potential to increase the success of~     immunosuppression (IS) therapy withdrawal in liver transplant (LT) recipients, thus~     decreasing the negative impact of IS on their long-term outcomes. Lifetime immunosuppression~     (IS) with standard agents, the calcineurin inhibitors (CNI) cyclosporine and tacrolimus~     (TAC), is currently required at clinically recommended doses and trough levels to prevent~     allograft rejection. However, this occurs at the significant expense of long-term CNI~     toxicity, i.e. chronic kidney disease (CKD), hypertension, hyperlipidemia, diabetes,~     infections and malignancy. With improvements in early graft and patient survival, long term~     adverse IS effects have become increasingly important in this rapidly expanding patient~     population. The strategies to reduce long term CNI toxicity include dose minimization that~     still leaves patients on CNI therapy, conversion to non-CNI therapy, or even complete IS~     withdrawal. The second approach, conversion to non-CNI IS therapy, is attractive in the~     potential to stabilize or improve renal function and other CNI toxicities. One such~     non-nephrotoxic IS agent, the mammalian target of rapamycin inhibitor (mTOR-I) SRL, has a~     different mechanism of IS action and studies have shown that CNI to SRL conversion can~     stabilize renal dysfunction with a low risk of rejection. Yet even with these possible~     benefits, patients on SRL are still subject to lifetime IS therapy with side effects and~     costs, highlighting the need to investigate the strategies that promote full IS withdrawal~     without rejection (3rd approach), also known as 'operational tolerance'.~   "
114943|NCT02062931|"~     Stem cells (SC) are the foundation cells for every organ, tissue and cell in the body. They~     are undifferentiated blank cells that do not yet have a specific function. Under proper~     conditions, they begin to develop into specialized tissue and organs. They are~     self-sustaining and can replicate themselves for long periods of time. They have the~     remarkable potential to develop into many different cell types in the body. They serves as a~     sort of repair system for the body, they can theoretically divide without limit to replenish~     other cells as long as the person is still alive. Premature ovarian failure (POF) is the loss~     of ovarian function in women less than 40 years. It is associated with sex steroid~     deficiency, amenorrhea, infertility and elevated serum gonadotropins. POF occurs in 1 % of~     women. In majority of cases the underlying cause is not identified. Management essentially~     involves hormone replacement and infertility treatment. This work aimed to evaluate the~     therapeutic potential of Autologous MSC transplantation in women suffering from Premature~     Ovarian Failure.~   "
114944|NCT02062918|"~     Objectives: To assess the effectiveness of an abdominal belt in the treatment of chronic~     mechanical-postural low back pain.~      Methods: A randomized controlled trial was carried out, involving 60 consecutively selected~     patients with chronic low back pain randomly allocated to an intervention group (use of~     abdominal belt) and control group (non-use of abdominal belt). Patients were evaluated at the~     baseline of the study (T0) as well as 1 (T1), 3 (T3) and 6 months (T6) after the inclusion.~     The patients were assessed for: pain (VAS); functional capacity (Roland Morris), patient~     satisfaction (Likert scale); and number of anti-inflammatory pills ingested.~     Intention-to-treat analysis was also used.~      Hypothesis - abdominal belt will improve pain in chronic low back pain patients~   "
114945|NCT02062905|"~     The purpose of this study is to evaluate the efficacy and safety of OTX-DP as a sustained~     release drug (dexamethasone) depot when placed in the canaliculus of the eyelid for the~     treatment of the signs and symptoms of chronic allergic conjunctivitis.~   "
114946|NCT02062892|"~     The investigators hypothesize that switching kidney transplant patients on~     tacrolimus/sirolimus long-term maintenance immunosuppressive drug regimens to~     tacrolimus/everolimus, will not only be safe, but will lead to better kidney function than~     patients staying on tacrolimus/sirolimus due to the lower potential of everolimus to enhance~     calcineurin inhibitors toxicity and/or its ability to even reverse some of the negative~     effects of calcineurin inhibitors on vascular endothelial and kidney function. To test this~     hypothesis vascular endothelial biomarkers will be analyzed in blood plasma samples and~     kidney dysfunction biomarkers in urine samples via liquid chromatography tandem mass~     spectrometry to evaluate whether switching kidney transplant patients on tacrolimus/sirolimus~     to tacrolimus/everolimus will lead to better kidney and endothelial function after one year~     and two years.~   "
114947|NCT02062879|"~     This study will compare ketamine and hydromorphone as alternative patient-controlled~     interventions for trauma-related pain. Patients receiving ketamine PCA are expected to~     require less total and breakthrough opioid and to have similar or improved objective pain~     scores. Patients receiving ketamine are also expected to have shorter duration of~     supplemental oxygen requirement, fewer episodes of oxygen desaturation, improved pulmonary~     toilet, lower use of antiemetics, and shorter times to first bowel movement. Ketamine is~     further expected to be associated with decreased intensive care unit and hospital lengths of~     stay, faster time to maximum allowable ambulation, decreased opioid dosage at discharge, and~     lower report of chronic pain syndromes.~   "
114948|NCT02062866|"~     To compare healing time, scar size, aesthetic outcome, and complication rates following~     second intention healing or purse string closure of surgical wounds on the trunk or~     extremities. This study, will allow surgeons to make informed decisions on whether purse~     string closure is superior to that of second intention healing and thus worth considering or~     inferior and not worth performing.~   "
114949|NCT02062853|"~     The primary aim of this study is to evaluate the effects of prospective patient education on~     patient satisfaction with administration of topical 5% 5-fluorouracil cream for the treatment~     of actinic keratosis involving the face, scalp, upper chest, dorsal hands and forearms.~     Specifically, this study aims to determine if prospective patient viewing of an educational~     video delineating treatment effects and expectations improves patient satisfaction and~     treatment completion rates.~   "
114950|NCT02062840|"~     The investigators have observed in an open trial that a single session of whole body~     hyperthermia (WBH) induced rapid antidepressant effects that persisted for at least a week in~     patients with major depression (MDD) severe enough to warrant inpatient hospitalization. In~     addition to reducing depression, the single session of WBH induced a prolonged reduction in~     mean core body temperature, consistent with basic science data from our group suggesting that~     hyperthermia activates a skin-to-brain pathway that have been shown in animals to be~     important for mood and body temperature regulation. Consistent with this known anatomy in our~     preliminary study in depressed patients, reductions in core body temperature were highly~     correlated with reductions in depressive symptoms over the same time period (one week post~     WBH). Moreover, patients with higher mean core body temperature prior to treatment had~     enhanced antidepressant effects. Because increased body temperature is an outcome of poor~     functioning in the skin-to-brain pathway activated by WBH our data suggests that WBH may~     actually sensitize this pathway in ways that promote changes in brain functioning known to~     promote emotional well-being. The results of our first open trial have encouraged us to~     conduct a larger, more rigorous placebo-controlled, double blind study of WBH for MDD, which~     is currently underway at the University of Arizona Medical School. Missing from our~     assessments in this ongoing double-blind study is any measure of the impact of WBH on brain~     function. The current proposal addresses ths gap in our investigative portfolio by proposing~     to conduct a second, randomized trial of active vs. sham WBH that will examine the impact of~     WBH on measures of brain function known from prior studies to be important for both~     depression and its treatment.~   "
114951|NCT02062827|"~     To determine the safety and tolerability of the maximum dose for laboratory engineered Herpes~     Simplex Virus-1 in patients who would not be eligible for surgical resection of recurrent~     glioma To determine the safety and tolerability of the maximum dose for laboratory engineered~     Herpes Simples Virus-1 in patients who would benefit from surgical resection of recurrent~     glioma~   "
114952|NCT02062801|"~     The combined spinal epidural (CSE) technique has become increasingly popular for labor pain~     because of its rapid onset and superior first stage analgesia. However, increased risk for~     early profound fetal bradycardia (EPFB) following CSE continues to be a concern. Various~     factors are implicated in the etiology of EPFB but the cause is unknown. Ephedrine~     administration prior to CSE analgesia may help reduce the risk of EPFB, but to date, nobody~     has studied the impact of a single dose of intravenous (IV) ephedrine given at the time of~     CSE administration during labor. The purpose of this study is to measure the incidence of~     EPFB after combined spinal epidural analgesia using standard definitions. The incidence of~     EPFB will be compared between patients who receive prophylactic ephedrine or placebo at the~     time of CSE placement.~   "
114953|NCT02062788|"~     Elective colectomy procedures typically require bowel preparation starting 2 days prior to~     the surgery. Osmotic laxatives such as Colyte® are administered 2 days prior, and Nothing by~     mouth (NPO) is required 1 day prior to ensure no fecal residue is left in the bowel. Though~     it may ensure a cleaner and safer surgery, this longer period of starvation increases insulin~     resistance and may increase post-op complications. However, there is evidence that~     administration of oral rehydration solution(ORS) prior to surgery reduces insulin resistance.~     Our purpose is to evaluate the difference of insulin resistance in those who received ORS 1~     day prior to surgery and those who did not.~   "
114954|NCT02062775|"~     The purpose of this study is to determine if self-fixating polyester mesh will have lower~     incidence of chronic postoperative pain and recurrence than non-fixating polyester mesh when~     used for laparoscopic inguinal hernia repair.~   "
114955|NCT02062762|"~     The main objective of the current study is to evaluate whether a mindfulness based~     intervention delivered online can provide an effective resource for increasing psychological~     well-being among students. In addition, explore potential mechanisms through which the~     training lead to improvements by means of mediational analyses, with hypothesized variables~     like positive/negative affect and attention regulation.~   "
114956|NCT02062749|"~     The goal of this clinical research study is to find the highest tolerated dose of heated~     intra-abdominal oxaliplatin that can be given to patients with colon cancer. Researchers also~     want to learn more about the ways that pediatric and young adult colon cancer may be~     different from colon cancer in adults.~   "
114957|NCT02062736|"~     The purpose of the study ( observational and prospective ) is to evaluate the efficacy and~     tolerability of the methadone maintenance treatment in patients addicted to heroin. The~     efficacy and tolerability are assessed by correlating to the adequacy of the dosage of~     methadone. The patients will be observed for two years.~   "
114958|NCT02062723|"~     The efficacy and tolerability of Eptadone® in the context of a maintenance program will be~     evaluated in an observational prospective, multicenter study, in heroin addicted patients.~   "
114959|NCT02062710|"~     The purpose of this study is to evaluate the antitussive (cough-suppressing) effects of two~     liquid medications: a combination of diphenhydramine and phenylephrine in a naturally cocoa~     flavoring, and, dextromethorphan syrup, compared with placebo.~   "
115018|NCT02061943|"~     This is a study of patients with spasmodic dysphonia to determine how best to measure the~     severity of the disorder in patients. It addresses which characteristics of speech are the~     best indicator of whether or not a particular treatment has benefited a person with spasmodic~     dysphonia. We hope to recruit 20 participants each at 2 different centers. The evaluation for~     each participant will be done on a two visits, one just before and another several weeks~     after treatment.~   "
114960|NCT02062697|"~     Epithelial Ovarian cancer (EOC) is the leading cause of death among gynaecologic malignancies~     in western civilized countries, with an estimated prevalence in Europe and the US of 752,600~     in 2007 and 59,828 deaths annually.~      State-of-the-art diagnostic tests for EOC include transvaginal ultrasonography and serum~     cancer antigen (CA-125) measurements; the specificity of these diagnostic tools however is~     low, and both tests are not effective enough at detecting EOC early enough to improve~     clinical outcomes. Definitive diagnosis of EOC still relies on histological or cytological~     confirmation. These findings underline the importance for an effective test for early~     detection of EOC.~      In the current project we will obtain a lavage of the uterine cavity. It will be investigated~     whether cells from EOCs or genetic material from those cells can be detected in the lavage~     fluid.~      Aim of this study:~      There is a clear clinical need for a diagnosis test to detect EOC at an earlier stage.~   "
114961|NCT02062684|"~     The purpose of this study is to evaluate the efficacy and safety of subcutaneous blisibimod~     administration in addition to standard therapy in patients with biopsy proven IgA Nephropathy~     with persistent proteinuria of between 1-6 g/day.~   "
114962|NCT02062671|"~     In patients with polycystic kidney disease, pain may be resistant to drug therapy and may~     reduce quality of life. This study investigate the effect of renal denervation on this pain.~   "
114963|NCT02062658|"~     This study investigates if a single dose of IV Ketamine can rapidly improve~     Obsessive-Compulsive Disorder (OCD) symptoms and whether these effect can be maintained with~     a condensed course of a type of Cognitive Behavioral Therapy called Exposure and Response~     Prevention (EX/RP). You will be compensated for your time and travel. Participants must be~     between the ages of 18-55.~   "
114964|NCT02062645|"~     The population that will be included in this study, will be regular Turkish hypertensive~     patients who are expected to consume sodium in high amounts. It is hypothesized that, in that~     population, amlodipine/valsartan will be effective at the same rate of blood pressure (BP)~     control rate as expected from literature.~   "
114965|NCT02062632|"~     This randomized pilot clinical trial studies the effects of taking doxepin hydrochloride as~     compared to placebo (inactive drug) in treating esophageal pain in patients with cancer~     located in the chest area receiving radiation therapy to the thorax with or without~     chemotherapy. Doxepin hydrochloride is a tricyclic antidepressant drug which was recently~     shown to be helpful for mouth pain in patients receiving radiation therapy. Doxepin~     hydrochloride affects the surface of the esophagus, which may be helpful in reducing the pain~     caused by radiation therapy.~   "
114966|NCT02062619|"~     Central alexia is a common reading disorder caused by stroke. Patients with central alexia~     (CA) are slow to read and make frequent errors, and have additional problems with their~     spoken language.~      This study has 3 aims:~        1. Investigating the neural networks that support reading in patients with CA Despite being~          a relatively common syndrome, there have been no functional brain imaging studies of CA.~          This project will use magnetic resonance imaging (MRI) and magnetoencephalography (MEG)~          to understand which brain regions are damaged and whether preserved parts of the reading~          network can be encouraged by therapy to support reading recovery.~        2. Testing a new treatment for CA The research team has developed training software called~          'iReadMore', which uses a crossmodal approach (written words paired with spoken words)~          to train reading. This therapy has been shown to be effective in patients with a similar~          form of reading disorder called pure alexia. The iReadMore software will be adapted to~          address the reading deficit in CA, and the research will test whether it significantly~          improves reading ability.~        3. Using brain stimulation to enhance behavioural training Transcranial direct current~          stimulation (tDCS) is a brain stimulation technique that has been shown to improve~          language performance in healthy controls and stroke patients. This study will test~          whether tDCS (delivered simultaneously with the 'iReadMore' therapy) significantly~          enhances reading rehabilitation. Patients will be split into two groups: one will~          receive a 4 week block of training plus real tDCS first, followed by a 4 week block of~          training plus sham tDCS; the other group will receive the two therapy blocks in the~          opposite order. Both groups will ultimately receive the same amount of behavioural~          therapy and tDCS stimulation. Comparing the reading improvement over the real and sham~          tDCS blocks will demonstrate whether tDCS enhances the behavioural improvements in~          reading ability.~      Hypothesis:~      iReadMore reading therapy will significantly improve single word reading speed in patients~     with central alexia.~      tDCS brain stimulation will significantly enhance the effect of iReadMore therapy, compared~     to sham stimulation.~   "
114967|NCT02062606|"~     To evaluate the restoration and maintenance of thoracic kyphosis and coronal curve correction~     demonstrated through the surgical implantation of the K2M MESA Rail™ Deformity System as~     compared to literature reported outcomes for standard Cobalt Chrome (CoCr) rod systems in the~     treatment of Adolescent Idiopathic Scoliosis (AIS).~   "
114968|NCT02062593|"~     In this study the investigators will use careful scientific blinding of patient and their~     subsequent healthcare staff so that the investigators can determine exactly how much~     difference coronary angioplasty makes to symptoms and blood supply to the heart. After the 6~     weeks blinded phase, all patients will be unblinded and the patients who had undergone sham~     procedure will be offered the active therapy.~   "
114969|NCT02062580|"~     In sub-Saharan Africa (SSA), more than 300,000 babies with HIV die each year. HIV-infected~     children develop AIDS and die faster in SSA than those in developed countries. Bacille~     Calmette-Guerin (BCG) vaccine is given to infants at birth in SSA to protect them from severe~     forms of TB. BCG is known to cause immune cells to be active and replicate faster. The immune~     system of neonates also responds differently to BCG that to other vaccines and infections. We~     hypothesize that the routine immunization of neonates with BCG contributes to generalized~     immune activation in HIV-exposed infants resulting in skewed immune responses to vaccines and~     infections and increased rates of disease progression in those infants that become~     HIV-infected. However, delaying BCG until HIV testing is completed would result in~     operational difficulties, and may not induce the appropriate immune response. Delayed BCG~     would also render many HIV-exposed uninfected infants at high risk for disseminated TB. We~     plan to assess immune cells in infants to determine the impact of the timing of BCG~     vaccination on immune responses to tuberculosis (TB) and other vaccines. We will also compare~     the immune activation and disease progression of those infants that become HIV-infected in~     the BCG or control arms. Our results will provide key insights into the effect of BCG~     vaccination on immune responses to HIV as well as inform the optimal timing of BCG~     vaccination for HIV-exposed infants.~   "
114970|NCT02062567|"~     With this project the investigators wish to:~        1. Test the reproducibility of Amlang's ultrasound classification by examining the intra-~          and inter-rater reliability.~        2. Investigate whether Amlang's ultrasound classification is able to predict which patients~          are likely to develop complications when treated non-operatively.~        3. Investigate whether Barfod's length measurement is able to predict which patients are~          likely to develop complications when treated non-operatively.~   "
114971|NCT02062554|"~     BHS is a cohort study of consecutive myocardial infarction (MI) patients admitted within the~     first 24 hours of symptoms and has been ongoing since May of 2006. The purpose of this study~     is to assess for possible markers for increased risk after MI.~   "
114972|NCT02062541|"~     Background: Illness and hospitalisation, even of short duration, pose separate risks for~     permanently reduced functional performance in elderly medical patients. Functional assessment~     in the acute pathway will ensure early detection of declining performance and form the basis~     for mobilisation during hospitalisation and subsequent rehabilitation. For optimal results~     rehabilitation should begin immediately after discharge.~      The aim of this study is to investigate the effect of a systematic functional assessment in~     the emergency departments (ED) of elderly medical patients with reduced functional~     performance when combined with immediate post-discharge rehabilitation.~      Method/design: The study is a two-way factorial randomised clinical trial. Participants will~     be recruited among patients admitted to the ED who are above 65 years of age with reduced~     functional performance. Patients will be randomly assigned to one of four groups: 1)~     functional assessment and immediate rehabilitation; 2) functional assessment and usual~     rehabilitation; 3) usual assessment and immediate rehabilitation; 4) usual assessment and~     usual rehabilitation.~      Primary outcome: 30-second chair-stand test administered at admission and two weeks after~     discharge.~      We hypothesise that such assessment in the ED or/and immediate rehabilitation will result in~     sustained or improved performance in comparison to regimen in which neither of these~     interventions are offered.~   "
114973|NCT02062528|"~     The main objective is to evaluate the effects of omega-3 fatty acids on hot flashes~     frequency.~   "
114974|NCT02062515|"~     The purpose of this study is to determine whether Icotinib is efficient and safe in treating~     advanced non-small cell lung cancer (NSCLC) patients with hepatic insufficiency.~   "
114975|NCT02062502|"~     This study will evaluate the immunogenicity, safety, and tolerability of VARIVAX™ (Varicella~     Virus Vaccine Live) manufactured with a New Seed Process (NSP) compared with the VARIVAX™~     2007 process. The primary hypotheses being tested are that antibody response rate and mean~     antibody titer induced at 6 weeks after a single vaccination by VARIVAX™ NSP are non-inferior~     to those induced by VARIVAX™ 2007 process, and that antibody response rate induced by~     VARIVAX™ NSP is acceptable.~   "
114976|NCT02062489|"~     The current study is a multicentre, randomized,double-blind, prospective clinical trial~     stratified patients by the HER2 status of their cancer (negative or positive) which is~     sponsored by the researchers. The trial is designed to evaluate the effectiveness of~     tamoxifen as adjuvant therapy for ER(ER-α)/PR negative, ER-β positive operable breast cancer~     patients. 688 female ER(ER-α)/PR negative, ER-β(wild type ER-β1) positive operable breast~     cancer patients who had undergone neoadjuvant chemotherapy or directly modified radical~     mastectomy or breast-conserving surgery were randomly (1:1) enrolled to receive tamoxifen (20~     mg per day) or placebo (2# per day) within 6 weeks after postoperative chemotherapy and/or~     radiation therapy if needed (according to 2013 NCCN breast cancer guideline). If the breast~     tumor's HER2 is positive, the patient can receive targeted therapy (Herceptin) combined with~     tamoxifen or placebo. The follow-up time will be eight years. The aim of this trial is to~     evaluate the effectiveness of tamoxifen as adjuvant therapy for ER(ER-α)/PR negative, ER-β~     positive operable breast cancer patients by comparing the DFS and OS between tamoxifen group~     and placebo group and to determine whether the percentage of positive ER-β expression is~     associated with the response to the hormone therapy in breast cancer.~   "
114977|NCT02062476|"~     Lactobacillus GG (LGG) is able to exert long lasting effects in children with atopic~     disorders. We have shown that Nutramigen LGG accelerates tolerance acquisition in infants~     with cow's milk allergy (CMA). The mechanisms of these effects are still largely undefined.~     The effect of LGG could be related at least in part by the immunoregulatory role played by~     LGG. This probiotic can balance the generation of cytokines possibly involved in IgE- or~     non-IgE-mediated CMA (i.e., IL-4, IL-5, IL-10, IFN-γ , TGF-beta, and TNF-alfa), which can~     contribute to modulation of inﬂammatory processes. We have demonstrated that children with~     IgE-mediated CMA produce significantly higher level of IL-4 and IL-13 in response to cow's~     milk protein, and that tolerance is associated with a marked reduction of IL-13 production~     and a concomitant increased frequency of IFN-γ releasing cells.~      Epigenetics studies the heritable (and potentially reversible) changes of the genome~     inherited from one cell generation to the next which alter gene expression but do not involve~     changes in primary DNA sequences, highlighting the complexity of the inter-relationship~     between genetics and nutrition. There are three distinct, but closely interacting, epigenetic~     mechanisms (histone acetylation, DNA methylation, and non-coding microRNAs) that are~     responsible for modifying the expression of critical genes associated with physiologic and~     pathologic processes. The profile of epigenetic modifications associated with Th lineage~     commitment, coupled with the sensitivity of the early developmental period, has led to~     speculation that factors that disrupt these pathways may increase the risk of allergic~     diseases. Specifically, effects on DNA methylation and endogenous histone deacetylase~     inhibitors acting on specific pathways (Th1 and T regulatory cell differentiation) may favour~     Th2-associated allergic differentiation. MicroRNAs are another structural components of an~     epigenetic mechanism of post-transcriptional regulation of messenger RNA translation. It has~     been recently identified a specific Th2-associated miRNA (miR-21) that is critical for the~     regulation of Th cell polarization.~   "
114978|NCT02062463|"~     This study is conducted to assess whether training participants on proper use of BF SPIROMAX~     and Symbicort TURBOHALER will improve their device-handling technique and potentially improve~     their treatment outcome, ie, better asthma control.~   "
114979|NCT02062450|"~     The purpose of this study is to demonstrate the performance and reliability of Tornier Dual~     Mobility Cup used during primary total hip replacement or hip replacement revision surgery~     at least 24 months post-insertion.~   "
114980|NCT02062437|"~     The aim of this study is to assess safety and general performance of total hip arthroplasty,~     composed of a Meije Duo® femoral stem associated with a Dynacup® cup, and using the friction~     pair Biolox® Delta Ceramic.~   "
114981|NCT02062424|"~     The objective of this study is to test the effect of substitution dietary guidelines that are~     specifically aimed at the prevention of ischemic heart disease (IHD) on the dietary intake in~     the general Danish population.~   "
114982|NCT02062411|"~     The purpose of this study is to determine whether cognitive behavioral therapy (CBT) is~     effective in the treatment of attention deficit and emotional, executive function and social~     function dysregulation due to attention deficit disorder (ADHD).~   "
114983|NCT02062398|"~     The current study will evaluate the safety and performance of the BlueWind Medical Reprieve~     System for the treatment of Chronic Painful Peripheral Neuropathy.~   "
115019|NCT02061930|"~     The aim of this study is to review the long-term soft tissue stability and the long-term~     esthetic results of single crowns supported by tissue level implants placed in non-augmented~     healed sites.~      The hypothesis of the present study is that tissue level implants can achieve ideal esthetic~     outcomes in non-augmented healed sites.~   "
114984|NCT02062385|"~     This study will assess the efficacy, safety, and immunogenicity of a 3-dose regimen of~     RotaTeq™ (V260) in healthy Chinese infants. Approximately 4040 participants at least 6 weeks~     and up to 12 weeks of age at the time of the first vaccination with V260 or placebo will be~     enrolled and randomized (1:1) to receive either V260 or placebo. Participants will also~     receive the routine China Expanded Program on Immunization (EPI) vaccines (oral poliovirus~     vaccine [OPV] and diphtheria, tetanus, and acellular pertussis vaccine [DTaP]) either~     staggered or concomitantly with V260 or placebo. All participants will be followed for~     efficacy and safety. Immune responses to OPV and DTaP will be evaluated in a subset of~     participants. The primary hypothesis of the study states that V260 will be efficacious in~     preventing any severity of rotavirus gastroenteritis as compared with placebo.~   "
114985|NCT02062372|"~     Currently, patients with a glioblastoma multiforme (GBM) are treated with a combination of~     different therapeutic modalities including resection, concurrent chemo- and radiotherapy and~     adjuvant temozolomide. However, survival is still poor and most of these tumours recur within~     one to two years within the previously irradiated target volume.~      The radiation target volume encompasses both the contrast-enhanced lesion on T1-weighted~     magnetic resonance imaging (MRI), plus a 1.5 - 2 cm isotropic margin in order to include~     microscopic speculated growth. These margins result in a high dose to surrounding healthy~     appearing brain tissue. Moreover, the short progression-free survival indicates a possible~     geographical miss. There is a clear need for novel imaging techniques in order to better~     determine the degree of tumour extent at the time of treatment and to minimize the dose to~     healthy brain tissue.~      The development of Ultra-High Field (UHF) MRI at a magnetic field strength of 7 Tesla (T)~     provides an increased ability to detect, quantify and monitor tumour activity and determine~     post-treatment effects on the normal brain tissue as a result of a higher resolution, greater~     coverage and shorter scan times compared to 1.5 T and 3 T images. Up to now, only few~     investigators have examined the use of UHF MRI in patients with malignant brain tumours.~     These studies show its potential to assess tumour microvasculature and post-radiation effects~     such as microhaemorrhages.~      This study analyzes the accuracy of the 7T MRI in identifying the gross tumour volume (GTV)~     in patients with an untreated GBM by comparing biopsy results to 7T images. These biopsies~     will be taken from suspected regions of GBM based on 7T MRI that do not appear as such on 3T~     MRI. We hypothesize that with the 7T MRI the GTV can be more accurately and extensively~     identified when compared to the 3T MRI.~   "
114986|NCT02062359|"~     Background:~      The National Cancer Institute (NCI) Surgery Branch has developed an experimental therapy for~     treating patients with melanoma that involves taking white blood cells from the patient,~     growing them in the laboratory in large numbers, genetically modifying them, and then giving~     the cells back to the patient. In a previous study, the NCI Surgery Branch used the~     anti-ESO-1 gene and a type of virus (retrovirus) to make these tumor-fighting cells~     (anti-ESO-1 cells). About half of the patients who received this treatment experienced~     shrinking of their tumors. In this study, we are using a slightly different method of~     producing the anti-ESO-1 cells selected for a specific cell type, which we hope, will be~     better in making the tumors shrink.~      Objectives:~      The purpose of this study is to see if these tumor fighting cells (genetically modified~     cells) that express the receptor for the ESO-1 molecule on their surface can cause melanoma~     tumors to shrink and to see if this treatment is safe.~      Eligibility:~      -Adults 18 and older with cancer that has the ESO-1 molecule on tumor surfaces~      Design:~        -  Work up stage: Patients will be seen as an outpatient at the National Institutes of~          Health (NIH) clinical Center and undergo a history and physical examination, scans,~          x-rays, lab tests, and other tests as needed~        -  Leukapheresis: If the patients meet all of the requirements for the study they will~          undergo leukapheresis to obtain white blood cells to make the anti ESO-1 cells.~          {Leukapheresis is a common procedure, which removes only the white blood cells from the~          patient.}~        -  Treatment: Once their cells have grown, the patients will be admitted to the hospital~          for the conditioning chemotherapy, the anti-ESO 1 cells and aldesleukin. They will stay~          in the hospital for about 4 weeks for the treatment.~      Follow up: Patients will return to the clinic for a physical exam, review of side effects,~     lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1~     year as long as their tumors are shrinking. Follow up visits take up to 2 days.~   "
114987|NCT02062346|"~     Patients with vasculitis commonly develop high blood pressure (hypertension) and this is~     associated with an increased risk of heart disease. It is thus important to lower blood~     pressure in those with hypertension. However, hypertension in vasculitis is inadequately~     controlled with many currently available blood pressure lowering agents.~      Endothelin is a chemical produced by blood vessels that contributes to the development of~     hypertension. Higher than normal levels of endothelin are seen in patients with vasculitis.~     By using drugs that block the effects of endothelin ('endothelin receptor antagonists') the~     investigators can hopefully treat hypertension in patients with vasculitis. The purpose of~     the study is to ascertain whether endothelin receptor antagonists lower blood pressure and~     improve blood vessel function more effectively in patients with vasculitis than those without~     it.~   "
114988|NCT02062333|"~     The aim of this study is to find the Effects of Anesthetics Used in Hypotensive Anesthesia on~     Stapes Reflex and Distortion Product Auto Acoustic Emission.~   "
114989|NCT02062320|"~     The aim of this study is to compare the efficacy of analgesic methods after Caesarean Section~     before and after Post Caesarean Acute Pain Service establishing.~   "
114990|NCT02062307|"~     The aim of this study is to investigate the markers of bone mineral metabolism in an~     unconfounded group of patients with hypogonadism and to search for a relationship between~     endothelial dysfunction and insulin resistance.~   "
114991|NCT02062294|"~     This retrospective review will evaluate the efficacy of Valcyte (valganciclovir) in~     preventing Cytomegalovirus (CMV) disease in D+/R- liver transplant recipients. Data from~     eligible patients will be collected for the 6 months following transplantation.~   "
114992|NCT02062281|"~     The 23-valent pneumococcal Polysaccharide vaccine (23vPPV) has been developed for children~     and adults to prevent pneumococcal diseases such as pneumonia (inflammation of the lungs),~     meningitis (inflammation of the brain lining), and septicemia (blood poisoning) since 2006 in~     China. Also, the trivalent influenza vaccine (TIV) is frequently administered to the children~     and adults. The main objective of this study is to show that both vaccines can safely be~     administered together without affecting the immune response of protecting against disease.~   "
114993|NCT02062268|"~     Conduct a KAP survey before and after intervention and describe the current knowledge,~     attitudes and behaviors on drink driving in public and analyse the influential factors to~     provide rational strategies to enhance the awareness on drink driving in public.~   "
114994|NCT02062255|"~     Obesity promotes worse outcome for post-menopausal breast cancer patients.~   "
114995|NCT02062242|"~     The purpose of this study is to evaluate the effectiveness of transvaginal electrical~     stimulation, vaginal palpation, and vaginal palpation associated with posterior pelvic tilt~     and contraction of accessory muscles in the acquisition of ability to contract the pelvic~     floor muscles (PFM), as well as to evaluate the sexual function of women studied.~   "
115020|NCT02061917|"~     To evaluate selected biomarkers of tobacco exposure and biomarkers of harm and assess quality~     of life measures in smokers randomly switched from their usual brand of cigarette to one of~     three test products: (1) a tobacco-heating cigarette; (2) snus (smokeless tobacco); or (3) an~     ultra-low machine yield tobacco-burning cigarette.~   "
114996|NCT02062229|"~     Infertility is a common problem, affecting perhaps one couple in six, the majority of whom~     now seek medical care. It is becoming a social challenge because it is responsible for~     personal and interpersonal discomfort and anxiety. A major obstacle to meaningful study of~     the epidemiology of male infertility is the difficulty in accurate diagnosis of the presence~     or absence of a problem. Traditionally, the diagnosis of male infertility is facilitated by~     the conventional assessment of the semen profile - constructed according to recognized~     guidelines (i.e. WHO) and including pH, cell count and motility - but no specific biomarkers~     are available.~      We sought to determine the oxysterol and fatty acid lipidome with the ai of finding a lipid~     biomarker useful for the diagnosis of male infertility.~   "
114997|NCT02062216|"~     The primary objective of this study is to assess whether inflammatory receptors play a role~     in the pathogenesis of atherosclerosis.~   "
114998|NCT02062203|"~     The main purpose of this study is to evaluate the effect of single oral therapeutic and~     supratherapeutic doses of AKB-6548 on the QT interval.~   "
114999|NCT02062190|"~     Resveratrol supplementation may improve cardiovascular risk factors and cognitive parameters~     in patients with schizophrenia taking antipsychotics?~   "
115000|NCT02062177|"~     Many studies address safety of non-anesthesiologist propofol sedation (NAPS) for~     gastrointestinal endoscopy. Target Controlled Infusion (TCI) is a sophisticated tool for~     providing optimal sedation regimen and avoiding under or oversedation. The objective of the~     study is to compare standard moderate sedation during upper endoscopy and colonoscopy versus~     propofol NAPS.~   "
115001|NCT02062164|"~     The use of bariatric surgery in adolescents is controversial. On one side, bariatric surgery~     is the only effective treatment to achieve sustained weight loss in adults with extreme~     obesity. Comorbidities are reversed and mortality is reduced. In adolescents, bariatric~     surgery is equally effective; however, due to the paucity of long-term data, the long-term~     effects and risks are unknown. Thus, due to surgical risk and ethical implications, bariatric~     surgery is considered experimental in Germany. Nevertheless, case volumes are increasing.~      The aim of this study is to evaluate the benefits and risks of adolescent bariatric surgery~     in the context of a structured preparation and follow-up program. The study is a subproject~     of the study Medical and psychosocial implications of adolescent extreme obesity -~     acceptance and effects of structured care (DRKS00004172). At 5 German university centers~     (Ulm, Datteln, Berlin, Essen, Leipzig), youth who undergo bariatric surgery and are~     participants in the overall project will be enrolled in a structured preparation and~     follow-up program. The program is designed to improve adherence and compliance and will~     result in comprehensive follow-up data. In addition to the data gathered in the overall~     project, subjects participating in subproject 3 will undergo assessments pertinent to~     bariatric surgery, as proposed in the American Teen-LABS study~     (http://www.cincinnatichildrens.org/ research/divisions/t/teen-labs/default/). Comparison~     will be made with BMI matched adolescents who participate in the overall project but do not~     undergo bariatric surgery.~      In November 2014 recruitment for the overall project was completed. However, patients~     interested in bariatric surgery will still be recruited until September 2016. There~     assessment will be the same as for patients recruited earlier. However, in an amendment in~     December 2014, the frequency of assessment via questionnaire was reduced from biannually to~     annually. In addition, a travel reimbursement of 30€ for each study visit was implemented.~   "
115002|NCT02062151|"~     This pilot study is intended to assess feasibility of auricular acupuncture in NAS infants~     who require pharmacologic therapy at Tampa General Hospital (TGH). We intend to evaluate~     acceptability of auricular acupuncture, infant tolerance, recruitment strategies, and~     methodological issues. We plan to also test and generate hypotheses in preparation to apply~     for funding a larger randomized controlled trial.~   "
115003|NCT02062138|"~     The purpose of the study is to determine the effectiveness of new interventional approaches~     in the early postoperative phase following total knee arthroplasty (TKA). It is assumed that~     active training programs are more effective in improving physical function than the passive~     standard-of-care therapy.~   "
115004|NCT02062125|"~     This is a 10 year study of scleroderma patients with calcinosis 1) to better understand how~     common and if there are any risk factors for having calcinosis~      2) to identify common complications associated with scleroderma-related calcinosis.~   "
115005|NCT02062112|"~     The purpose of this study is to determine whether the pattern of flavoring and drinking of~     laxatives for colonoscopy can improve the experience of patients when they are undergoing~     bowel preparation for the test.~      Investigators hypothesize that patients will have a better experience if patients taste the~     bowel preparation laxative with and without flavoring and then decide how they want to drink~     the rest of the laxative since taste preferences vary widely from person to person.~   "
115006|NCT02062099|"~     Alzheimer's disease (AD) is the most common cause of dementia in elderly subjects. AD is~     characterized by brain lesions like extracellular deposits of ß-amyloïd proteins in senile~     plaques and intracellular neurofibrillary tangles of hyper-phosphorylated tau protein, both~     of which are associated with the loss of neurons. The development of disease biomarkers for~     AD (Tau, PhTau and βamyloid dosing in the cerebrospinal fluid, brain MRI, amyloid PET imaging~     and fluorodeoxyglucose PET imaging) to identify the pathophysiological processes underlying~     cognitive impairment biomarkers, have been incorporated into revised diagnosis guidelines.~      Post-mortem human AD and AD animal model studies have reported inflammatory processes also~     implicated in the neuropathology of AD, and upregulated levels of pro-inflammatory cytokines.~      In vivo visualization of microglial activation has become possible with the development of~     molecular imaging ligands (tracers) for use with positron emission tomography (PET). The~     translocator protein (TSPO) formerly known as the peripheral benzodiazepine receptor (PBR), a~     receptor located in the outer membrane of mitochondria, is upregulated during~     neuroinflammation. So targeting TSPO with radiolabeled ligands for PET is considered as an~     attractive biomarker for neuroinflammation.~      The main aim of this pilot study is to quantify neuroinflammation, in terms of fixation and~     distribution of [18F] DPA-714(Binding Potential BP), and to study its relationship with~     amyloid load, measured with in [18F]AV-45 (Standard Uptake Values ratio) in cognitive~     decline.~   "
115007|NCT02062086|"~     Current methods for the quantification of muscle mass are indirect, lack precision, and often~     rely on expensive equipment that only provides limited (indirect) data on whole body muscle~     mass. Dual energy X ray absorptiometry has emerged as a potential precise measure of lean~     mass, easy to use in clinical practice and research. However, it assesses an indirect~     measurement of total-body skeletal muscle mass and its clinical use for determination of~     changes in muscle mass may be very limited due to instrumentation availability, particularly~     in field studies, and cost. Moreover, these methods provide estimates of fat free mass that~     is not skeletal muscle specific, and are influenced by changes in regional or total body~     water content.~      GlaxoSmithKline (GSK) has developed a novel technique using deuterium labeled creatine~     dilution for the estimation of muscle mass and has begun clinical evaluation of this~     muscle-measure in healthy young and older adults.~   "
115010|NCT02062047|"~     The aim of this study will be to evaluate: 1- the effect of full-mouth (FM) scaling and root~     (SRP) planing in 24 hours associated with or without extensive application of chlorhexidine~     (CLX) on clinical, microbiological, glycemic and immunological parameters in diabetic~     subjects with chronic periodontitis at 3, 6 and 12 months post-therapy. The hypothesis is~     that FMSRP associated with CLX use will provide the best clinical, microbiological, glycemic~     and immunological outcomes for the treatment of diabetic subjects with periodontitis. Sixty~     diabetic subjects with chronic periodontitis will be divided in the following therapeutic~     groups (n=20 subjects per group): FMSRP+CLX group - FMSRP in a maximum of 24 hours,~     application and irrigation of chlorhexidine 2% gel, rinsing chlorhexidine 0.12% solution~     during 60 days; FMSRP + placebo group - FMSRP in a maximum of 24 hours, application and~     irrigation of placebo, rinsing placebo solution during 60 days; Partial-mouth (PM) SRP group:~     SRP in 4-6 sessions in a maximum of 2 weeks. The following clinical parameters will be~     evaluated at 3, 6 and 12 months post-therapy: plaque accumulation, gingival bleeding, probing~     depth, clinical attachment level, bleeding on probing and suppuration. At these same periods,~     glycated hemoglobin levels will be obtained from all subjects. In addition, six subgingival~     biofilm samples per subject will be analyzed by checkerboard DNA-DNA hybridization for 40~     bacterial species at baseline, 3, 6 and 12 post-therapy. Finally, gingival crevicular fluid~     samples from two shallow and two deep sites will be evaluated for the levels of~     cyto/chemokines by ELISA. Data will be submitted to appropriate statistical analysis.~   "
115011|NCT02062034|"~     The purpose of this study is to evaluate the efficacy of ubiquinone and combined antioxidant~     therapy on progression, clinical regression, oxidative stress markers and mitochondrial~     dysfunction in non-proliferative diabetic retinopathy.~   "
115012|NCT02062021|"~     Autoimmune diseases are diseases in which inappropriate immune responses that have the~     capability of harming host cells play an important role. Evidence suggests that the presence~     of certain autoimmune diseases such as rheumatoid arthritis or systematic lupus erythematosus~     increase the risk of cardiovascular disease (CVD). However, this evidence is inconsistent for~     autoimmune disorders and no systematic approach has been previously used to study the~     relationship between a range of common autoimmune disorders and specific forms of~     cardiovascular diseases such as myocardial infarction, intracerebral and subarachnoid~     haemorrhage, or venous thrombosis.~      The investigators will use linked electronic health records to investigate whether commonly~     diagnosed autoimmune disorders are associated with increased risk of CVD development and~     whether effects differ in men and women and change with age.~   "
115013|NCT02062008|"~     The purpose of this study is to understand how simultaneous PET/MR acquisition can provide~     novel qualitative and quantitative biomarkers to guide clinical intervention and predict~     prognosis of patients with cardiovascular disease.~   "
115014|NCT02061995|"~     Osteoporosis is a systemic skeletal disease characterized by low bone mass and~     microarchitectural deterioration of bone tissue, with a subsequent increase in bone fragility~     and susceptibility to fracture.~      Osteoporosis is one of the most common and debilitating chronic diseases, and a global health~     concern with a high prevalence not only in Western countries, but also in Asia and Latin~     America. Most efficacious anti-osteoporotic treatments either inhibit bone resorption like~     bisphosphonates or denosumab or increase bone formation like teripartide an anabolic agent.~     Anti-osteoporotic drugs have demonstrated safety and efficacy with an increase in bone mass~     and a decrease of fracture risk (at the hip) by 30 to 50% after 3 years of treatment (Black~     et al., 1996; Neer et al., 2001; Meunier et al., 2004). Despite the availability of~     pharmacological treatments, osteoporosis remains a significant health problem for patients~     who do not respond to the available treatments or fail to comply with their regimens.~      The present phase 2a study aims to demonstrate the safety and efficacy of PREOB®, a~     proprietary population of autologous osteoblastic cells, in the treatment of osteoporotic~     patients who do not respond to pharmacological treatments.~   "
115015|NCT02061982|"~     Subjects will perform experiments in an at home-setting. The effect of caffeine in coffee~     will be tested in subjects with computer tests on attention and alertness. Comparison of the~     results with published results from controlled experiments will indicate the effectiveness of~     home experiments.~   "
115016|NCT02061969|"~     This is a study to determine whether glycemic control, as measured by change in HbA1c and~     frequency of hypoglycemia, is different between treatment with linagliptin (Tradjenta®) and~     basal insulin in long term care residents(LTC) with Type 2 diabetes(T2D). Patients with~     poorly controlled diabetes (HbA1c >7.5%) will be randomized to a 6-month intervention with~     linagliptin or glargine insulin (± metformin for both treatments). Our hypothesis is that~     treatment with linagliptin, a once daily DPP4-inhibitor, will result in similar improvement~     in glucose control but in a lower rate of hypoglycemia than insulin treatment in LTC~     residents with T2D. We will also determine differences in clinical outcome, resource~     utilization, and hospitalization costs between LTC residents with T2D treated with~     linagliptin and basal and correction insulin. We will compare differences in complications~     (infectious and non-infectious, neurological and cardiovascular events), emergency room~     visits and hospitalizations between groups during the 6 months of intervention.~   "
115017|NCT02061956|"~     Hepatocellular carcinoma (HCC) is the 6th most common cancer worldwide and the third most~     frequent cause of death of cancer.Although with the development of medical science, more and~     more patients diagnose HCC at early stage, a lot of patients with HCC still continue to~     present with multiple tumors or port vein thrombosis. According to AASLD guidelines, these~     patients could received transcatheter arterial chemoembolization (TACE) or new agents as~     initial treatment. However, the intermediate group comprises a wide spectrum in terms of~     liver function and extent of tumour, and this may explain the large differences in survival~     reported for individual series.~      A simple, pragmatic and reliable prognostic index based on objective measures would be of~     value in providing information to patients, for stratifying patients entering clinical trials~     and in making meaningful comparisons between series reported in the literature.The aims of~     our study were (i) to identify predictors of survival in a cohort of patients undergoing TACE~     or TAE for unresectable HCC, (ii) to develop and validate a simple scoring system and (iii)~     to compare the new scoring system with the most frequently used prognostic systems for its~     ability to separate high- and low-risk patients.~   "
115041|NCT02061644|"~     We aim to investigate the effect of spinal anesthesia on intraocular pressure.~   "
115021|NCT02061904|"~     Prospective explorative study for the investigation of short-term and medium-term outcomes~     regarding bone mineral density changes after revision hip arthroplasty making use of bone~     impaction grafting. Outcome measurements will include objective and subjective clinical data,~     complications and adverse events, radiographic data measurements recorded at several~     postoperative intervals.~   "
115022|NCT02061891|"~     The aim of this study is to evaluate if acute invasive coronary evaluation and treatment~     conducted within 12 hours of diagnosis improves clinical outcome compared to a deferred,~     subacute strategy in patients with unstable angina pectoris (UAP) / non-ST segment elevation~     myocardial infarction (NSTEMI) Acute coronary syndrome (ACS) Furthermore, in an observational~     design the potential clinical benefit of coronary computed tomography angiography (CCTA) to~     select patients for invasive investigation and treatment in the two treatment arms (acute vs~     deferred) is evaluated.~      The following main hypothesis will be tested:~        -  Very early invasive coronary investigation improves clinical outcome in patients with~          UAP/NSTEMI-ACS~        -  CCTA performed before invasive coronary investigation will improve clinical management~          of patients with UAP/NSTEMI-ACS~   "
115023|NCT02061878|"~     The primary objective of this proof of mechanism pilot clinical trial is to determine if the~     RXR agonist bexarotene acts in humans to alter the CSF levels of apoE and alter the clearance~     of Amyloid-Beta~   "
115024|NCT02061865|"~     The primary objective of the study is to investigate the safety of intravitreal (IVT)~     REGN2176-3 in patients with neovascular wet age-related macular degeneration (AMD).~   "
115025|NCT02061852|"~     The purpose of this study is to determine whether the medical device simeox is safe in the~     treatment of respiratory diseases, in comparison with traditional physiotherapy.~   "
115026|NCT02061839|"~     Main objective is to show that a photoprotective sunscreen having a protection against the~     visible light is more effective than a sunscreen having the same UVA AND UVB protection but~     with a low (weak) protection against the visible, to prevent the relapses of the melasma~     during the summertime.~   "
115027|NCT02061826|"~     The purpose of the study is to establish drug-induced liver injury databases in China, make~     criteria for Chinese drug-induced liver injury patients and evaluate the application of~     certain circulating miRNA in diagnosis or treatment of drug-induced liver injury.~   "
115028|NCT02061813|"~     The purpose of the study is to determine the irritation potential of repeat applications of~     abametapir lotion on normal skin.~   "
115029|NCT02061800|"~     The purpose of this study is to learn more about the effects of (classification determinant)~     CD34+ stem cell selection on graft versus host disease (GVHD) in children, adolescents, and~     young adults. CD34+ stem cells are the cells that make all the types of blood cells in the~     body. GVHD is a condition that results from a reaction of transplanted donor T-lymphocytes (a~     kind of white blood cell) against the recipient's body and organs. Study subjects will be~     offered treatment involving the use of the CliniMACS® Reagent System (Miltenyi Biotec), a~     CD34+ selection device to remove T-cells from a peripheral blood stem cell transplant in~     order to decrease the risk of acute and chronic GVHD.~      This study involves subjects who are diagnosed with a malignant disease, that has either~     failed standard therapy or is unlikely to be cured with standard non-transplant therapy, who~     will receive a peripheral blood stem cell transplant. A malignant disease includes the~     following: Chronic Myeloid Leukemia (CML) in chronic phase, accelerated phase or blast~     crisis; Acute Myelogenous Leukemia (AML); Myelodysplastic Syndrome (MDS); Juvenile~     Myelomonocytic Leukemia (JMML); Acute Lymphoblastic Leukemia (ALL); or Lymphoma (Hodgkin's~     and Non-Hodgkin's).~   "
115030|NCT02061787|"~     The application of cardiopulmonary exercise testing in assessment outcomes of patients with~     pulmonary hypertension.~   "
115031|NCT02061774|"~     The purpose of this project is to study the effects of preoperative followed by scheduled~     intravenous acetaminophen on pain control for 24 hours postoperatively after minimally~     invasive 1 or 2 level transforaminal lumbar interbody fusion.~   "
115032|NCT02061761|"~     The primary objective of this study is to characterize the safety, tolerability and maximum~     tolerated dose of BMS-986016 administered alone or in combination with Nivolumab to subjects~     with relapsed hematologic malignancies. Co-primary objective is to investigate the~     preliminary efficacy of BMS-986016 in combination with nivolumab in subjects with relapsed or~     refractory Hodgkin lymphoma (HL), and relapsed or refractory Diffuse Large B Cell lymphoma~     (DLBCL)~   "
115033|NCT02061748|"~     This study is an opportunity for Boehringer Ingelheim to collaborate with Humana to conduct~     comparative safety and effectiveness studies of dabigatran and warfarin using real world data~     from Humana's health plan operations.~   "
115034|NCT02061735|"~     A combined set of quantitative skin imaging methods will quantitatively describe the natural~     ontogeny and the response to standard treatments over time in patients with infantile~     hemangiomas.~   "
115035|NCT02061722|"~     The aim of this study is to measure the availability of the PDE10A enzyme in Huntington~     disease gene expansion carriers (HDGECs) using the recently developed radioligand~     [18F]MNI-659. The study will be cross-sectional, examining HDGECs at different stages of the~     disease (pre-manifest, stage 1 and stage 2), in comparison with Healthy Controls (HCs). The~     HDGECs included in this study will be recruited from the large database of the REGISTRY~     (NCT01590589) or ENROLL-HD (NCT01574053) studies.~   "
115036|NCT02061709|"~     The purpose of this study is to determine whether Ragweed-SPIRE is safe and effective at~     reducing allergy symptoms in people who suffer from allergy to Ragweed pollen~   "
115037|NCT02061696|"~     The goal of the research study is to observe the clinical safety, effectiveness and patient~     satisfaction of the AXERA 2 Access System in subjects undergoing coronary angiographic and~     possible Percutaneous Coronary Intervention (PCI) through the femoral artery when compared to~     standard manual compression.~   "
115038|NCT02061683|"~     This is a study of bimatoprost as initial, replacement, or adjunctive intraocular pressure~     (IOP)-lowering therapy in patients with primary open angle glaucoma and ocular hypertension.~   "
115039|NCT02061670|"~     The purpose of this study is to determine whether it is safe to administer Ragweed-SPIRE to~     subjects suffering from both ragweed allergy and asthma.~   "
115040|NCT02061657|"~     The aim of this research work is to assess the effect of using single preoperative dose of~     rectal misoprostol in abdominal myomectomy operations on blood loss, duration of the~     operation and possible operative complications~   "
115042|NCT02061631|"~     Primary Objective:~      To evaluate the overall response rate (including complete response and partial response) of~     subjects treated with combination therapy docetaxel and cisplatin followed by the~     chemoradiotherapy in patients with locally advanced head and neck cancer~      Secondary Objective:~      To assess the safety and tolerability of combination therapy docetaxel and cisplatin followed~     by the chemoradiotherapy in patients with locally advanced head and neck cancer~   "
115043|NCT02061618|"~     The Culturally Relevant Exercise for Diabetes (CURE-D) study will determine whether a~     culturally-sensitive dance intervention is an accepted and effective physical intervention~     for South Asian women with type 2 diabetes mellitus. The CURE-D study will determine if~     Bollywood dance exercise improves diabetes outcomes in South Asian women.~   "
115044|NCT02061605|"~     The objective of this pilot study will be to obtain a clinical safety and efficacy endpoint~     profile of laser tissue welding therapy for sealing the resected kidney surface after~     laparoscopic partial nephrectomy required for removal of resectable benign or malignant renal~     tumors in 10 patients.~   "
115045|NCT02061592|"~     To evaluate the clinical performance of daily disposable etafilcon A lenses.~   "
115046|NCT02061579|"~     The Initiate and Maintain Physical Activity in Clinics (IMPACT) study will determine the~     optimal and feasible level of frequency of structured contact needed in a clinical setting~     for adult patients with Type 2 Diabetes Mellitus to initiate and maintain physical activity~     recommendations long-term.~   "
115047|NCT02061566|"~     Indoxyl sulfate (IS) is an anionic uremic toxin that is accumulated in the serum of patients~     with uremia. In previous study, the investigators successfully induced AKI animal model. IS~     enhanced intercellular adhesion molecule-1 (ICAM-1) expression in IL-1β-treated human~     umbilical vein endothelial cells (HUVECs) that this may play a critical role in the~     progression of AKI. However, the molecular mechanisms of ICAM-1 expression in IS-treated~     IL-1β-treated HUVECs need to be elucidated. HUVECs incubated with 0.2 or 1 mM IS for 24 h did~     not cause cytotoxicity. The IL-1β-induced ICAM-1 expression in HUVECs was significantly~     enhanced by IS pretreatment. Furthermore, the regulation of adhesion molecule expression~     involves a complex array of intracellular signaling pathways including mitogen-activated~     protein kinase (MAPKs), reactive oxygen species (ROS) and transcriptional factors. A better~     understanding of this might provide important insights into the prevention of AKI.~   "
115048|NCT02061553|"~     This investigation addresses emotional health in community dwelling persons with traumatic~     brain injury (TBI). It is designed to test the efficacy of a novel behavioral treatment for~     depression and anxiety symptoms. This treatment incorporates principles of Behavioral~     Activation (BA), a promising treatment model for depression and anxiety after TBI, and~     implementation intentions, a theoretically motivated method to enhance enactment of~     goal-relevant behaviors via action planning. To maximize the impact of this intervention over~     time, we use the low-cost, widely available technology of SMS, or text messaging, to promote~     positive behavior change in accordance with planned goals and intentions. Participants are~     randomized 2:1 to a condition using BA-based implementation intentions or to a control~     condition in which participants receive SMS messages with self-selected motivational~     statements.~   "
115049|NCT02061540|"~     The study is an open-label study in adults with primary sclerosing cholangitis to evaluate~     the safety, tolerability, and effect of 14-weeks of daily dosing of LUM001.~   "
115050|NCT02061527|"~     To evaluate breast reconstruction with implants using biological mesh (Strattice™) in the~     setting of breast cancer treatment.~   "
115051|NCT02061514|"~     -  Major surgery can lead to postoperative disturbances in sleep patterns with subjective~          deterioration of sleep quality according to patients' reports as well as objective~          alterations of sleep architecture, as recorded by polysomnography~        -  Factors implicated in postoperative sleep disturbances include but are not limited to~          the severity of the surgical procedure, the neuroendocrine response to surgery,~          inadequate treatment of postoperative pain and external factors interfering with sleep,~          such as light, noise and therapeutic procedures~        -  There are differences in the molecular mechanisms inhalational anesthetics and~          intravenous agents affect different brain regions to induce anesthesia. Our hypothesis~          is that these differences may also be evident during the postoperative period, affecting~          brain functions which are involved in postoperative sleep architecture. So, the aim of~          this study will be to assess the effect of two different anesthetic techniques (propofol~          versus desflurane) of maintaining general anesthesia in patients subjected to similar~          major operations~        -  Patients will be assessed with the Pittsburgh Sleep Quality Questionnaire (PSQI),~          regarding preoperative and long term postoperative sleep quality, sleep diaries~          regarding early postoperative sleep quality and biochemical markers (cortisol, prolactin~          and melatonin) regarding neuroendocrine response to surgery and disturbances in~          endogenous circadian secretion associated with sleep~   "
115052|NCT02061501|"~     Visual cognitive deficits in children are frequent, with an impact on working and daily~     activities. Optometric therapy may improve those functions, however few studies have been~     performed.~      We aim to evaluate the efficacy of such therapy by a comparative study between two groups of~     children aged between 5 and 12 after 6 months of rehabilitation.~   "
115053|NCT02061488|"~     The purpose of the study is to assess a new closed-loop algorithm in type 1 diabetes (Saddle~     Point Model Predictive Control : SP-MPC)~   "
115054|NCT02061475|"~     Venipuncture and intravenous cannulation are the most common painful procedures, especially~     for the penitents who must receive large diameter venous catheter before surgery. In present~     study we would evaluate the safety and validity of lidocaine patches releasing such pain.~   "
115055|NCT02061462|"~     The procurement of organs from donors after cardiocirculatory death (DCD) is an accepted~     strategy to increase organ supply.~   "
115056|NCT02061449|"~     This study evaluates the safety and tolerability of the addition of immunostimulatory therapy~     consisting of focal radiation with or without the Toll-like receptor (TLR) agonist Poly ICLC~     in patients with cutaneous T-cell lymphoma (CTCL) receiving concurrent therapy with the~     histone deacetylase inhibitor (HDACI) Romidepsin.~   "
115100|NCT02060877|"~     The purpose of this study is to gain insight in the distress experience and quality of life~     of patients suspected of having a serious lung disease during the diagnostic phase and the~     period between diagnosis and start of treatment~   "
115057|NCT02061436|"~     Percutaneous coronary intervention (PCI) of chronic total occlusions (CTOs) is increasingly~     being performed in patients with advanced coronary artery disease, but there is limited~     information on the techniques utilized and the procedural outcomes. The goal of this~     multicenter, investigator initiated registry is to collect information on treatment~     strategies and outcomes of consecutive patients undergoing CTO PCI among various~     participating centers. The information collected will be used to determine the frequency of~     CTO PCI performed at the participating sites and examine the procedural strategies utilized,~     and the procedural (both immediate and during follow-up) outcomes.~   "
115058|NCT02061423|"~     The primary goals of this trial will be to determine the safety and immune activity of HER-2~     pulsed DC1 vaccine in patients with high risk HER-2pos breast cancer with residual disease~     post neoadjuvant therapy. Investigators will also explore the possibility of determining~     whether circulating tumor cells can be used as surrogate to assess response to vaccination.~   "
115059|NCT02061410|"~     The purpose of this study is to determine the effects of neuromuscular electrical stimulation~     (NMES) on neuromuscular and functional parameters in elderly with knee osteoarthritis.~      The hypothesis is that NAMES is able to strengthen the quadriceps muscle and to improve~     healthy status of elderly with knee osteoarthritis.~   "
115060|NCT02061397|"~     The purpose of this research study is to see if simvastatin can be taken safely in patients~     with either LAM or TSC, who are already being treated with everolimus or sirolimus. This is~     the first step in looking at simvastatin as a drug that may help patients, by impacting the~     growth and survival of cells that make up the lung lesions that cause problems in LAM and TSC~     patients. The study also seeks to learn more about how simvastatin works, when given to~     patients being treated with everolimus or sirolimus, and to evaluate the safety and any~     potential benefit to patients taking this 2-drug combination.~      The primary objective of this study is to determine the safety of simvastatin in the~     treatment of LAM-S or LAM-TS in patients on a stable (for at least 3 months) dose of~     sirolimus or everolimus.~      Secondary objectives include:~        -  To assess the effect of simvastatin on forced expiratory volume in 1 second (FEV1).~        -  To assess the effect of simvastatin on forced vital capacity (FVC).~        -  To assess the effect of simvastatin on diffusing lung capacity (DLCO).~        -  To assess the effect of simvastatin on vascular endothelial growth factor -D (VEGF-D)~          serum levels.~        -  To assess the effect of simvastatin with questionnaire- based assessments of dyspnea,~          fatigue, and quality of life (QOL).~        -  Assess signs of clinical benefit.~   "
115061|NCT02061384|"~     Men with infertility and normal hormone levels have few options for fertility treatment.~     Previous research work has suggested that men with infertility may have low levels of the~     active form of Vitamin A, called retinoic acid, in their testes. We think that giving men~     with low sperm counts retinoic acid may increase their sperm counts and improve their chances~     of fathering a pregnancy. We want to see if retinoic acid administration over twenty weeks~     can increase sperm production and help infertile men become fathers without the need for In~     vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI). We also want to see~     if adding calcitriol with retinoic acid will improve sperm motility in a sub-set of subjects.~   "
115062|NCT02061371|"~     Evaluate the effectiveness of virtual therapy and conventional physiotherapy in spastic~     muscles of patients with sequelae of stroke.~   "
115063|NCT02061358|"~     The objective is to evaluate the safety and tolerability of a single-ascending oral dose of~     UV-4B in healthy subjects and to determine pharmacokinetic parameters describing absorption~     and elimination following a single dose of UV-4B in healthy subjects.~   "
115064|NCT02061345|"~     Mild cognitive impairment (MCI) with ageing is thought in part to be related to reduced serum~     sex hormones which is well-recognized, especially in females, but poorly understood.~     International studies assessing hormone replacement therapy (HRT) to prevent/reduce MCI are~     ongoing. MCI leads to morbidity, reduced quality of life and substantial healthcare costs.~     The commonest therapeutically induced reduction in sex hormone level in men is treatment of~     prostate cancer (PCa). PCa is androgen dependent and androgen deprivation therapy (ADT)~     suppressing testosterone to castrate levels is key therapy for advanced disease. About one~     million men worldwide have received ADT for PCa, mostly using luteinising hormone releasing~     hormone agonists (LHRHa) although oral oestrogens were used in the past; eventually perhaps~     4% of Caucasians may be castrated. MCI as a side effect of castration in men remains poorly~     researched. This study aims to demonstrate that pathological changes occur in the brains of a~     significant proportion of prostate cancer patients subjected to ADT that correlate with MCI~     symptoms. Highlighting the pathological changes of MCI should improve understanding and~     interventions for slowing/preventing MCI in PCa survivors. Brain scans employing positron~     emission tomography (PET) imaging technique will be used to detect the presence of~     pathological changes in the brain that relate to ADT induced MCI. MCI will be assessed by~     neuropsychological assessments (standard paper-based questionnaires and online) and its~     neural basis will be investigated using magnetic resonance imaging (MRI).~   "
115065|NCT02061332|"~     Women who are diagnosed with Her-2/neu over-expressing DCIS will receive DC1 vaccines by~     intranodal, intralesional, or both routes of administration. The primary objective will be~     safety and administration with secondary objectives of immune activation and clinical~     response.~   "
115066|NCT02061319|"~     The main purpose of our project is to see if a 12-week program of Nordic walking is better~     than standard exercise therapy for increasing exercise capacity (measured by how far people~     can walk in 6 minutes) and increasing quality of life (measured by having people fill out two~     questionnaires). We will also see if Nordic walking: improves heart performance (measured by~     heart ultrasound); improves how active people are (measured by an activity monitor);~     increases aerobic fitness (measured by a treadmill test); improves body composition (measured~     by waist size); and reduces hormone levels in the blood.~   "
115067|NCT02061306|"~     Celiac disease (CD) is a complex disease caused by eating gluten, a protein contained in~     wheat, rye, and barley. It is well known that many factors contribute to the development of~     CD, including the genes that you have and the foods that you eat. In the CDGEMM study, we~     will consider as many of these factors as possible and study how they each contribute to~     disease development. If the investigators find that any one factor, or combination of~     factors, increases the risk of developing CD, we will be able to apply this information and~     help prevent or detect disease in high-risk children in the future.~   "
115068|NCT02061293|"~     Several lines of evidence suggest that classic hallucinogens such as psilocybin can~     facilitate behavior change in addictions such as alcohol dependence. The proposed~     investigation is a multi-site, double-blind active-controlled trial (n = 180, 90 per group)~     contrasting the acute and persisting effects of psilocybin to those of diphenhydramine in the~     context of outpatient alcoholism treatment.~   "
115069|NCT02061280|"~     Asthma is an inflammatory disease that imposes a significant burden affecting an estimated~     300 million persons and 20% of all children worldwide. It is one of the most common chronic~     diseases of childhood and is a leading cause of school absenteeism. There continues to be a~     great need for clinical trials in asthma but traditional clinical trials are expensive and~     reasons cited by patients for non-participation are extra inconvenience and logistical~     barriers. Study designs which are patient centered and reduce trial costs are needed. The~     long-range goal of this application is to transform the paradigm of clinical research into a~     more efficient and cost-effective enterprise by capitalizing upon current widely used mobile~     electronic means of communication and information transfer.~      This innovative project is a streamlined clinical trial that will run concurrently with a~     nearly identical traditional clinical trial, Long-acting Beta Agonist Step Down Study~     (LASST) which will allow for direct comparison of processes and outcomes between the~     streamlined and traditional approach. Children 12 to 17 years old with asthma will be~     randomized to participate in this project (streamlined trial) or LASST (traditional trial).~     In this proposal we will: measure comprehension of study information using an original~     questionnaire, Research Participant Assessment (developed at Nemours), following a parental~     permission/assent process delivered over the internet in a dynamic interactive multi-media~     format (Specific Aim 1); measure the efficiency of participant driven data entry from home~     into a Research Electronic Data Capture (REDCap) online database using the iPad, and quality~     of spirometry with the EasyOne Plus handheld meter with remote coaching using the iPad~     (Specific Aim 2); test whether the streamlined approach has a trial effect by comparing the~     differences in Asthma Control Test (ACT) scores following 12 weeks of study drug treatment in~     children randomized to this project compared to LASST. We will collect effort reporting data~     to compare personnel costs between the trials. If this streamlined project lacks a trial~     effect and reduces costs compared to LASST, the methodologies would be generalizable to~     studies which include adults and other diseases.~   "
115070|NCT02061267|"~     The metabolic syndrome may be defined as the constellation of cardiovascular disease (CVD)~     risk factors that comprises obesity, type 2 diabetes, dyslipidemia, and hypertension. Lack of~     habitual physical activity and certain dietary patterns, including high-saturated fatty acids~     (SFA) intake, contribute to increase the risk of CVD, whereas the greatest risk reduction is~     related with monounsaturated fatty acids (MUFA), mainly from olive oil, and omega-3~     polyunsaturated fatty acids (PUFA). Vitamin B3, as a major substrate for nicotinamide~     phosphoribosyltransferase (NAMPT), has also emerged as a nutritional intervention strategy~     for prevention of CVD.~      NAMPT has been shown to exert activities of central importance to cellular energetics and~     innate immunity. Within the cell, NAMPT is the rate-limiting step in a salvage pathway of~     nicotinamide adenine dinucleotide (NAD+) biosynthesis. By virtue of this role, it can~     regulate cellular levels of NAD+ and thereby NAD+-consuming enzymes. NAMPT is also released~     by a variety of cells, and elevated levels can be found in the systemic circulation of~     subjects with a range of inflammatory disorders.~      Recent evidences suggest that, primarily due to its high MUFA content, olive oil is useful as~     an optimal fat for the modulation of CVD risk factors in the postprandial state. In addition,~     NAMPT has been shown to correlate with triglycerides in the fasting plasma, and a potential~     regulatory role for fatty acids on NAMPT expression has been proposed.~      The global aim of the project is to assess whether olive oil (MUFA), compared to other~     dietary fatty acids (SFA and omega-3 PUFA) and in association with vitamin B3 could have~     benefits on NAMPT-related inflammation and atherosclerosis. We hope to provide important~     novel insights on the relationship among dietary fatty acids, NAD+ metabolism, and metabolic~     syndrome. This aim is expected to be achieved in one principal objective:~      To elucidate the influence of olive oil (MUFA), butter (SFA) or fish oil (omega-3 PUFA) meals~     supplemented by vitamin B3 on postprandial NAMPT modulation and its involvement on leukocyte~     inflammatory response in subjects with metabolic syndrome.~   "
115071|NCT02061254|"~     Explorative study on a medical device with two steps. The first pilot step will be on 8~     patients (4 with lymphedema and 4 with venous insufficiency). The main objective is to assess~     the feasibility of measures by high resolution transient elastography on these pathologic~     skins, and to define 3 areas for measures.~      The second step will be on 136 participants (48 healthy volunteers, 48 with venous~     insufficiency and 40 with unilateral lymphedema of a limb). The main objective is to~     quantify, by high resolution transient elastography, the dermal and hypodermal cutaneous~     fibrosis in limbs with lymphedema and venous insufficiency, and to compare it to healthy~     skin.~   "
115072|NCT02061241|"~     Cardiac resynchronisation therapy (CRT) using biventricular pacing (BiVP) is established as~     an effective treatment for heart failure. Unfortunately up to 45% of patients do not respond,~     with no improvement in symptoms or cardiac size. Reducing the proportion of non-responders~     has become the key research focus in CRT.~      Targeting the position of the left ventricular (LV) pacing lead within the coronary vein~     network has previously been shown to increase the proportion of responders to CRT. Several~     techniques have been tried for targeting lead position, of which the best investigated are~     the use of speckle-tracking echocardiography to target the lead position to the site of~     latest mechanical activation of the left ventricle, and the use of invasive monitoring to~     select the pacing site at which the greatest acute haemodynamic response (AHR) to BiVP~     occurs. Both techniques are limited by groups of patients in whom the techniques are not~     possible or provide limited useful information.~      The relationship between these two measures is unknown - there are no previous studies that~     have investigated correlation between the site of latest mechanical activation determined by~     echo and the site of maximal AHR. It is likely that a hybrid technique using both of these~     investigations might allow optimal lead positioning in more patients, or that if the~     information is shown to be equivalent, more streamlined techniques can be designed.~      This study will also be able to contribute towards several important secondary questions. In~     particular the investigators will study the possibility of using non-invasive cardiac output~     monitoring (NICOM) to assess haemodynamic response rather than an intravascular pressure~     monitor wire. The investigators also wish to assess whether the site of latest mechanical~     activation is changed by right ventricular pacing.~   "
115073|NCT02061228|"~     A randomised controlled open-label clinical trial to assess the effect of artificially~     induced endometrial injury and repair during ovarian stimulation on the clinical pregnancy~     rate of an antagonist downregulated in-vitro fertilisation cycle~   "
115074|NCT02061215|"~     Using novel CYTOF technology to measure a wide array of innate and adaptive cell proportions~     and cytokine levels, we plan a pilot study in old (>/=60 years) and young (20-40 years) renal~     transplant recipients who are CMV seropositive (regardless of donor serology). Viral load~     measurements will be performed at baseline prior to transplant (within 1 week),and then at 3,~     7 and 10 months after transplant. It is expected that the patient will receive anti-CMV~     prophylaxis until 6 months post-transplant, so the latter two time points will reflect~     responses after release from antiviral suppression. Each patient will serve as their own~     control, with comparisons made between measurements at baseline and then at each timepoint.~      Blood from 10 patients in each age group will be studied, to collect virologic and immune~     response data:~        -  CYTOF (broad array of measurements)~        -  Tetramer assays (requires recipient HLA type of A1, A2, B7)~        -  CMV viral load PCR~        -  Response to pneumococcal antigens and inactivated influenza virus~      In addition, clinical data will be collected at the time points indicated,particularly renal~     function and the presence/absence of acute rejection.~   "
115141|NCT02060344|"~     The Hispanic Community Health Study / Study of Latinos (HCHS/SOL) is a multi-center~     epidemiologic study in Hispanic/Latino populations to determine the role of acculturation in~     the prevalence and development of disease, and to identify risk factors playing a protective~     or harmful role in Hispanics/Latinos.~   "
115075|NCT02061202|"~     The proposed research is designed to test the global hypothesis that inhaled corticosteroids~     (ICS), a therapy developed to treat asthma, will prevent vasoocclusive painful episodes in~     adults with SCD who wheeze, but do not meet criteria for a diagnosis of asthma. The specific~     aims of this proposal are 1) Conduct a feasibility study - a randomized controlled trial of~     ICS for adults with SCD who do not meet criteria for a diagnosis of asthma but report~     recurrent cough or wheezing, 2) Measure the effects of ICS on biological correlates of~     pulmonary inflammation (as determined by exhaled nitric oxide) and vascular injury (as~     determined by sVCAM) in SCD, and 3) Compare properties of traditional and Bayesian adaptive~     clinical trial design for therapeutic trials in SCD in preparation for designing a definitive~     trial of ICS. These aims have the potential to 1) change the standard of care for individuals~     with SCD and recurrent cough or wheeze, 2) provide insight into the pathogenesis of~     non-asthmatic wheezing in SCD and its response to treatment, 3) explore the suitability of~     innovative clinical trial designs to overcome the challenges that have hindered therapeutic~     innovation for SCD.~   "
115076|NCT02061189|"~     This clinical trial aims to test a new physio-therapeutic approach tailored to type 2 and 3~     Spinal Muscular Atrophy patients, based on physical training in swimming-pool. This specific~     exercise should promote motor skills of trained patients, as we have observed in different~     mouse models. Patient's motor skills will be assessed using different scales including MFM~     and Hammersmith.~      This clinical trial attempts to develop a new non-invasive motor scale with sophisticated~     instruments.~      This scale will be useful in future clinical trials on SMA, given the lack of sensitivity of~     currently available scales.~      In addition, the study attempts to validate a questionnaire on post-exercise physical~     well-being.~   "
115077|NCT02061176|"~     A randomised study comparing Transanal Haemorrhoidal Dearterialization (THD) and Open~     Haemorrhoidectomy (OH) for the treatment of prolapsing haemorrhoids. The primary aim of the~     study is to evaluate the long-term effect on haemorrhoidal symptoms one year postoperatively.~      Secondary endpoints are postoperative pain, complications, effect on anal continence,~     recovery and return to normal activity, quality of life and health cost analysis.~   "
115078|NCT02061163|"~     To determine if contrast enhanced ultrasound (CEUS) and shear wave elastography can~     accurately diagnose bowel wall inflammation and fibrosis in patients with known Crohn's~     disease.~   "
115079|NCT02061150|"~     Sepsis is a significant cause of morbidity and mortality among newborns. Due to strict~     criteria and in order to diagnose and prevent early-onset group B streptococcal (EOGBS)~     sepsis, many infants undergo a sepsis workup due to risk factors alone, even though they are~     asymptomatic. Our goal is to evaluate the number of newborns that undergo sepsis workup due~     to risk factors alone, to determine the number of newborns having positive blood cultures,~     and to establish ways to reduce the number of asymptomatic infants undergoing sepsis workup.~   "
115080|NCT02061137|"~     The Trial Objective is to assess safety and efficacy of oral fingolimod (FTY720) in children~     older than 6 years with Rett Syndrome. So far there is no established treatment for children~     with Rett Syndrome. Therefore a positive result in terms of safety and first indications of~     efficacy would path the way to a phase II clinical study with more patients to further test~     the hypothesis that fingolimod treatment may slow down the regression of motor and language~     skills.~   "
115081|NCT02061124|"~     Accumulating evidence suggests that bile acids and bacteria in our intestines may constitute~     essential components in the complex mechanisms regulating gut hormone secretion and glucose~     homeostasis. At the same time, bile acids and gut bacteria are interdependent. Thus, it is~     likely that modification of the enterohepatic circulation of bile acids can lead to changes~     in gut hormone secretion or gut bacteria composition and consequently affect glucose~     homeostasis.~      The current study is a human interventional study with 7-day ingestion of a bile acid~     sequestrant or placebo, preceded and followed by meal tests and faecal sampling. The aim is~     to examine how (and if) bile acid sequestration can influence postprandial glucagon-like~     peptide-1 (GLP-1) secretion, gut microbiota and glucose homeostasis in patients with type 2~     diabetes and healthy individuals. As a tool to sequester bile acids we will use sevelamer, a~     phosphate binding resin used in the treatment of hyperphosphataemia in adult patients with~     chronic kidney disease. Surprisingly, sevelamer was recently shown to improve glycaemic~     control in patients with chronic kidney disease and type 2 diabetes.~      The investigators hypothesize that higher luminal concentrations of bile acids in the distal~     gut will elicit changes in the postprandial gut hormone secretion and gut bacteria~     composition. The current study will help to clarify this hypothesis and improve our general~     understanding of the association between bile acid circulation and signalling, gut hormone~     secretion, gut bacteria and glucose metabolism.~   "
115082|NCT02061111|"~     Previously, studies have shown that children of women with thyroid autoantibodies experience~     more birth complications and poorer health in their first days. Studies have also shown later~     signs of cognitive developmental challenges (risk of attention deficit/hyperactivity~     problems) among children of mothers with autoimmune thyroid disease. In Denmark there is no~     formalized screening or treatment of subclinical thyroid disease - with or without Thyroid~     Peroxidase Antibodies (TPO-antibodies) - among pregnant women.~      The hypothesis of this study is that the offspring of women with subclinical thyroid disease~     have a mitochondria-dysfunction which leads to more complications during birth, poorer health~     and well-being in the early childhood. The investigators will test this by recruiting mothers~     by a blood sample in the third trimester of pregnancy, screen the cord blood at birth and~     later on test the children with Bayley test two times in the early childhood.~   "
115083|NCT02061098|"~     The investigators objective is to carry out a placebo-controlled, dose-response, randomized~     clinical trial to assess the effects of polyphenols or derived metabolites on cardiovascular~     disease risk in overweight adult subjects upon the consumption of pomegranate extract.~      The investigators hypothesis is that chronic consumption of a ellagitannin-rich source such~     as pomegranate extract could decrease serum oxidized-LDL as well as other inflammatory~     markers. The correlation between the effect exerted and the subjects' microbiota (capacity to~     produce the ellagitannin-derived metabolites urolithins) will indicate a possible role of~     urolithins on the effects.~   "
115185|NCT02059772|"~     The primary objective of this study is to evaluate if a combination therapy with micropulse~     diode laser treatment shows non inferiority on visual acuity within 12 months in comparison~     to standard therapy (intravitreal injection of ranibizumab only).~   "
115084|NCT02061085|"~     Multicentre, prospective, non-controlled phase II clinical trial to evaluate the efficacy and~     tolerability of first line single agent Eribulin in patients with HER2-negative metastatic~     breast carcinoma previously exposed to taxanes for early stage.~      The primary objective of the study is to determine the median time to progression achieved~     with Eribulin. Other secondary objectives will be; overall response rate, clinical benefit~     rate, time to treatment progression, duration of response and toxicity profile.~   "
115085|NCT02061072|"~     The aims of this trials are:~        1. to collect published and unpublished individual classic pharmacokinetic data (individual~          patient data from independent investigators and pharmaceutical companies)~        2. to make available population pharmacokinetic models for the concentrates derived from~          the data collected~        3. to develop a web based application intended to use the above models to calculate~          pharmacokinetic parameters for individual patients, and~        4. to test the system functionality via simulation of the use of the prototype by use of~          faked test data.~   "
115086|NCT02061059|"~     The purpose of this study is determine whether the use of plantar pressure measurements in~     the production of customized therapeutic footwear for patients with diabetes and a history of~     foot ulceration results in lower production costs and more pressure relief, compared to the~     standard production. A secondary objective is to explore if a difference in durability can be~     observed in pressure reduction and development of (pre-) ulcerative lesions between the shoes~     produced with and without plantar pressure measurements.~   "
115087|NCT02061046|"~     To study the impact of CPAP therapy on gait in patients with obstructive sleep apnea~     syndrome.~   "
115088|NCT02061033|"~     Patients with hemophilia who have the same level of deficient factor(s) may express different~     severity of clinical presentation and bleeding tendency. Therefore a test which could~     determine overall hemostasis rather than simple concentration of a single deficient factor~     may correlate better with clinical phenotype in these patients.~      The investigators will therefore study the usefulness of global hemostatic methods~     (endogenous thrombin potential (ETP), overall hemostatic potential (OHP), fibrin clot~     structure) and microparticles in the prediction of severity of bleeding and estimation of~     response to the treatment in patients with hemophilia.~      Since hemophilia patients on prophylactic treatment virtually do not bleed, additional~     patients who are treated on demand only will be included enabling to study possible~     modulatory effects of different hemostatic factors (particularly prothrombotic and thrombin~     activatable fibrinolysis inhibitor (TAFI)) on clinical presentation. The investigators will~     correlate both those factors and clinical severity with global hemostatic methods.~      The investigators expect to prove that individual tailoring of the treatment, which may~     enable lowering the prophylactic dose of factor concentrate without increasing the risk of~     bleeding, is justified in some hemophilia patients. This approach would reduce the amount of~     necessary factor concentrate in certain patients and decrease the cost (which represents~     extensive burden for health care systems) of treatment without potential risk for the~     patients.~   "
115089|NCT02061020|"~     Study of the effects of smoked cannabis consumption on performance on a driving simulator and~     reaction time. The study aims to explore the relationship between concentrations of cannabis~     in the blood, driving performance and reaction time.~   "
115090|NCT02061007|"~     The purpose of this study is to determine if magnetic resonance imaging (MRI) or positron~     emission tomography (PET) imaging can be used to help doctors determine how much oxygen a~     tumor is getting. Hypoxyprobe will be used to determine the levels of oxygen post-surgery in~     the current study. If the study is successful, then imaging can be used to determine a~     tumor's oxygen status even in patients who are not getting surgery.~      Investigators want to find out how much oxygen is in the participants tumor based on how much~     pimo is present, and correlate this with the results of their MRI and 18F-fluoromisonidazole~     (FMISO) PET scan.~      This study is also testing the investigational radioactive substance known as FMISO. FMISO is~     used during PET scans to help doctors see how much oxygen a tumor is getting. Participants~     might be asked to participate in an optional PET scan using FMISO.~   "
115091|NCT02060994|"~     Background: It is known that after Cesarean section is correlated with respiratory~     complication more, if done after 37-38 week of gestation than if done after 39 weeks or more.~      Goal: The aim of the current study is to find out if these respiratory complications extend~     to later life.~      Methode: Reviewing the patients' medical file, and collecting data about respiratory~     complication.~   "
115092|NCT02060981|"~     Investigators will conduct a randomized trial with patients, through one-on-one interviews,~     to evaluate their understanding of and willingness to use a decision support tool and to~     determine if receiving and discussing the decision support tool improves the likelihood that~     a patient is adherent to a new antihypertensive medication.~   "
115093|NCT02060968|"~     The purpose of this study is to evaluate effectiveness and safety of Promus PREMIER in~     Routine Clinical Practice~   "
115094|NCT02060955|"~     The overall purpose of the study is to investigate the efficacy and safety of ALECSAT in~     patients with relapse of GlioBlastoma Multiforme (GBM) after first line treatments (followed~     by reoperation if possible). The efficacy and safety of ALECSAT treatment is, compared to~     standard Bevacizumab/Irinotecan second line treatments for these patients.~   "
115095|NCT02060942|"~     Determining fluid responsiveness in critically ill patients by measuring mean systemic~     filling pressure on the intensive care unit.~   "
115096|NCT02060929|"~     The primary purpose of the study is to evaluate the pharmacokinetics (what the body does to~     the medication) of intranasally (through the nose) administered esketamine using a device~     with and without a nasal guide in healthy participants.~   "
115097|NCT02060916|"~     This study is to evaluate the effect that PAZ320 has on post-prandial glucose excursions~     measured via continuous glucose monitoring and its adverse effect profile in humans.~   "
115098|NCT02060903|"~     The purpose of the study is to assess the efficacy, safety and tolerability of a single~     application of abametapir lotion 0.74% w/w compared to a vehicle control, when applied to the~     scalp and hair for 10 minutes at home.~   "
115099|NCT02060890|"~     This current study will use a new treatment approach based on each patient's tumor genomic~     profiling consisting of whole genome sequencing, exome analysis, and RNA sequencing as well~     as predictive modeling. This new treatment strategy has shown promising results in adult~     patients with other solid tumors.~   "
115101|NCT02060864|"~     In this trial, the effect of a low and a high dose AN-PEP will be investigated in gluten~     sensitive individuals. Volunteers receive a breakfast with background (0.5 g) gluten.~     Capsules are taken in the morning within 5 min after start of breakfast. Gastrointestinal~     fluid will be sampled over 3 hours to measure gluten degradation. After 5 volunteers have~     completed 3 test days, a blind interim analysis is performed by a third party based on which~     it is decided whether to proceed with the low AN-PEP dose.~   "
115102|NCT02060851|"~     There are wide variations in iron supplementation practices in NICU.Guidelines on paediatric~     Parenteral nutrition suggested the dose of 200μg/kg.d iron by parenteral nutrition.In our~     early study serum ferritin and TIBC were not statistically significant before and after~     intervention by used the dose of intravenous iron.In our study,we find twhether iron combined~     EPO can improve iron state in preterm.~   "
115103|NCT02060838|"~     Acute normovolemic hemodilution (ANH) is part of our current protocol to decrease~     post-operative bleeding and homologous blood transfusions post cardiopulmonary bypass. Blood~     is drawn from our patients pre-bypass after obtaining the arterial line and administered back~     to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin~     with protamine. In our practice we noticed some variability in the impact of ANH on~     postoperative bleeding; with some patients appearing to show more hemostasis after separation~     from CPB than others. This is a prospective study to find out if there is an optimal time~     period that guarantees the largest amount of functioning platelets and what is the best~     practice for drawing and storing of ANH to guarantee the largest amount of functioning~     platelets.~   "
115104|NCT02060825|"~     This project is evaluating the validity of regional saturation monitoring in evaluating~     changes in the mesenteric perfusion. Regional saturation monitoring is a standard of care in~     many institutions, including NCH. Advances in the technology and recent approval of the use~     of CASMED devices for this purpose will allow us to use this technology more effectively. We~     aim to evaluate if there is a change in the mesenteric blood flow during the pre, intra and~     post operative period for the hybrid procedure and the balloon atrial septostomy procedure~     (BAS).~   "
115105|NCT02060812|"~     Purpose: The purpose of this study is to compare the result of combined sono-guided~     suprascapular nerve block (SSNB) and axillary nerve block (ANB) with isolated SSNB in~     postoperative pain following arthroscopic rotator cuff repair. Our hypothesis was that SSNB~     combined ANB would show a more effective anesthesia for arthroscopic rotator cuff repair as~     compared with SSNB only.~      Methods: Forty-two patients with rotator cuff tear who had undergone arthroscopic rotator~     cuff repair were enrolled in this study. Among them, 21 patients were randomly allocated into~     group I, and received SSNB and ANB with each 10mL ropivacaine. The other 21 patients were~     allocated into group II, and received SSNB with 10mL ropivacaine and ANB with 10mL normal~     saline. Visual Analogue Scale (VAS) pain score, patient's satisfaction (SAT), and Lateral~     Pain Index (LPI), etc was checked at postoperative 1, 3, 6, 12, 18, 24, 36, and 48 hours.~   "
115106|NCT02060799|"~     Braunwald defines dyspnoea as an abnormally uncomfortable awareness of breathing. Breathing~     discomfort, and its varying degrees of severity, is the one of the most disturbing symptoms~     patients can experience; and it is one of the main complaints in the patients presenting to~     the Emergency Department (ED). Dyspnea has a variety of underlying etiologies, like cardiac,~     pulmonary or metabolic etiologies or a combination of them, since several diseases can cause~     dyspnea like for instance heart failure (HF), asthma and chronic obstructive pulmonary~     disease (COPD).~      Acute heart failure syndrome (AHFS) is collectively defined as a gradual or rapid change in~     heart failure (HF) signs and symptoms resulting in a need for urgent therapy. Heart failure~     (HF) is one of the most important causes of morbidity and mortality in the industrialized~     world. The prevalence of symptomatic HF is estimated to range from 0.4 to 2.0% in general~     European population. The incidence increases rapidly with age, and in Europe.~     Characteristics, clinical presentation, treatment, and outcomes of HF patients admitted to~     hospital have been adequately described, in Europe and in the United States. The Euro Heart~     Failure Survey (EHFS) I with 11 327 patients described the demographics of acutely~     hospitalized HF patients. The ADHERE registry has data on over 100 000 hospitalizations for~     AHF from the USA. In-hospital mortality was 4 and 7%, in ADHERE and EHFS I, respectively.~      This same sensation of breathlessness is what also drives patients with asthma and chronic~     obstructive pulmonary disease (COPD) to the ED. Chronic obstructive pulmonary disease (COPD)~     exacerbation accounts for approximately 1.5 million ED visits in the United States per year.~     It is the third most common cause of hospitalization, with an estimated 726 000~     hospitalizations in 2000 in the USA. Previous studies have demonstrated important differences~     between guideline recommendations and actual management of COPD exacerbation, either in the~     ED or during hospitalization.~      The diagnosis in front of a dyspneic patient in the ED remains a challenge, because of a low~     sensitivity of the clinical signs associated with the aging of the population and the variety~     of underlying diseases. Little is known about the Epidemiology of dyspneic patients in the ED~     at the European level. Diagnosis, prevalence and treatment of the patients may vary among~     European countries.~   "
115107|NCT02060786|"~     This study demonstrates the effect of generic clopidogrel bisulfate (Plavitor®) in comparison~     with the original clopidogrel bisulfate (Plavix®) in patients with acute coronary syndrome.~   "
115108|NCT02060773|"~     To observe the effect of early goal directed therapy (EGDT) on hepatic perfusion in patients~     with septic shock.~      Hypothesis: Hepatic perfusion did not improved after EGDT in patients with septic shock.~   "
115109|NCT02060760|"~     Hypothesis: High sensitivity cTnI assays will have improved diagnostic accuracy for type 1 MI~     compared to contemporary cTnI assays.~      The primary objective of the study is to determine the performance of a high sensitivity~     cardiac troponin I (hs-cTnI) assay compared to a contemporary cTnI assay for the diagnostic~     accuracy of type 1 acute myocardial infarction (AMI).~      The diagnostic performance of Abbott's hs-cTnI assay will be evaluated. Investigators will~     assess the assay's ability to diagnose AMI earlier and to rule out AMI earlier. The~     sensitivity, specificity, positive predictive value and negative predictive value of the~     hs-cTnI assay will be evaluated with both a universal cut off as well as with gender and~     potentially age derived 99th percentile upper reference limits (URL).~      Investigators will evaluate delta hs-cTnI values (pre-specified absolute concentration and~     percent changes over time) for their ability to contribute to the negative predictive value~     and hence potentially lead to an earlier rule out of AMI (improved specificity).~     Additionally, investigators will assess delta changes of the hs-cTnI assay for their~     potential contribution to the clinical differentiation of type 1 and type 2 (supply demand~     mismatch) MIs.~      Lastly, investigators will compare the diagnosis of AMI based on the currently used~     contemporary assay to the hs-assay, to assess both the incidence of AMI as well as for the~     time to diagnosis.~   "
115186|NCT02059759|"~     The primary objective is to evaluate in ALS patients the regulatory T cell early response to~     two low-doses of IL-2 at 1 and 2 MIU per day after one course of 5 consecutive days~     comparatively to placebo.~   "
116271|NCT02045589|"~     The purpose of this study is to determine the safety and tolerability of three intratumoral~     injections of VCN-01 combined with Abraxane®/gemcitabine, and to determine the recommended~     phase II dose of VCN-01 combined with Abraxane®/gemcitabine.~   "
115110|NCT02060747|"~     Harrington's metaphorical depiction captures the essence of the problem : Osteoporosis care~     of fracture patients has been characterized as the Bermuda Triangle made up of orthopaedists,~     primary care physicians and osteoporosis experts into which the fracture patient disappears.~      The most effective way to achieve this goal is through implementation of coordinator-based~     post fracture models of care. Exemplar models have been refered to as Fracture Liaison~     Service (United-Kingdom [1-3], Europe [4,5] and Australia [6-8]) Osteoporosis Coordinator~     Program (Canada [9,10]) or Care Manager Programs (USA [11,12]).~      The objective of this trial is to assess efficacy of a new coordinator-based post-fracture~     program in the Saint-Joseph Hospital in Paris to improve the management of osteoporosis after~     fracture thanks to an optimal recommendations practice to reduce the incidence of secondary~     fractures.~      Men and women are included aged over 45 years with fragility wrist and hip fractures.~      Evaluation criteria are based on the evidence-based assessment (stratify risk, identify~     secondary causes of osteoporosis, fracture evaluation), the medication adherence, others~     prescriptions adherence (osteodensitometry), the incidence of secondary fractures and number~     of falls.~      Number of patients : 200 Duration of the study: 3 years Patients' participation duration: 6~     months~   "
115111|NCT02060734|"~     To determine the efficacy of lidocaine injection of trigger points versus subcutaneous~     injection in patients with subacute whiplash associated disorder following injury.~   "
115112|NCT02060721|"~     Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used~     for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH)~   "
115113|NCT02060708|"~     Non-invasive human brain stimulation using weak transcranial direct‐current stimulation~     (tDCS) has been thousands of times in research studies over the past fifteen years as a~     therapy to help improve the effectiveness of repeated training sessions (e.g., hand exercises~     in the context of daily physiotherapy), due to its safety, tolerability, convenience and~     cost‐effectiveness. tDCS works by temporarily enhancing brain activity during performance of~     a specific task, helping with learning and training.~      The investigators will use magnetoencephalography (MEG) brain imaging to view the real‐time~     effects of high definition (HD) tDCS on several brain areas involved in vision, hearing,~     movement, and memory. The investigators hypothesize that changing the task (auditory, visual~     or memory task) but keeping the position of the electrodes over the motor cortex will result~     in modulation of brain activity in only the central target motor area, and not on non-target~     temporal, occipital or pre-frontal areas.~   "
115114|NCT02060695|"~     The purpose of this study is to determine the temporal relationship between motor~     fluctuations and non-motor fluctuations in persons with Parkinson's disease.~      Observational study case-only~   "
115115|NCT02060682|"~     This registry will collect real-world clinical evidence on the performance, safety, and~     usability of the ACIST CPM System and NAVVUS Catheter when used in accordance with approved~     labeling in a European commercial setting. Up to 60 subjects will have Fractional Flow~     Reserve (FFR) measurements of coronary lesions attempted with the CPM System and NAVVUS~     Catheter. All subjects will receive diagnostic treatment according to clinical indications~     and center standard practice.~   "
115116|NCT02060669|"~     Colorectal cancer (CRC) accounts for 10% to 15% of all cancers and is the second leading~     cause of cancer deaths in Western countries. Approximately half of all patients develop~     metastatic disease and become candidates for the palliative chemotherapy which has been~     proved to prolong survival and improve quality of life (QOL) in patients with metastatic CRC.~     The most active chemotherapy regiments include oxaliplatin or irinotecan combined with~     fluoropyrimidines.~      With overall survival in metastatic CRC nowadays routinely around 2 years, the same intensity~     of therapy can hardly be maintained throughout the course of therapy. The continuum of care~     therefore mandates changes in therapy, with treatment breaks or phases of less-intensive~     maintenance therapy interspersed with periods of more-intensive therapy to control tumor~     progression. Thereby, chemo-holidays conceivably reduce the cumulative toxicities of~     chemotherapy, potentially prevent the unplanned, premature discontinuation of therapy,~     preserve the ability to administer further phases of therapy, potentially maximize the time~     on therapy, reduce cost, and could increase QOL for patients. Several trials have tested the~     influence of chemo-holidays on patient outcome, with various rules on when to stop which~     component of antitumor therapy as follows; 1) Completely stopping all therapeutic agents,~     giving patients a completely chemotherapy-free interval (OPTIMOX-2, GISCAD), or 2) Stopping~     only those agents associated with significant (cumulative) toxicity while continuing other~     agents as maintenance therapy (OPTIMOX-1, Combined Oxaliplatin Neurotoxicity Prevention Trial~     [CONcePT]).~      Therefore, we'd like to test if capecitabine maintenance after 8 cycles of capecitabine~     combine with oxaliplatin (XELOX) could prolong progression-free survival without~     deterioration of QOL and toxicities in patients metastatic CRC.~   "
115117|NCT02060656|"~     This is a randomised, phase II open-labelled two-arm study comparing R-GEM-P and LR-GEM in~     second-line treatment of Diffuse Large B-cell lymphoma. Eligible patients will be randomised~     1:1 between R-GEM-P and LR-GEM.~   "
115118|NCT02060643|"~     Some patients with head and neck cancer or benign tumours of the head and neck receive~     radiotherapy to their neck as part of their treatment. The carotid arteries are often~     included in the radiotherapy as collateral structures. There is some evidence to show that~     radiotherapy to these blood vessels can result in thickening of the artery walls some years~     after treatment and increased risk of stroke or TIA in the future.~      Current research is now aimed towards detecting radiotherapy-related changes to the carotid~     arteries at an earlier stage and towards using new radiotherapy techniques to avoid treating~     these blood vessels if possible. The question of whether or not the use of preventive~     medicines like aspirin and cholesterol-lowering tablets helps to reverse this process is~     currently unanswered.~      The aim of this study is to measure the thickness (intima-medial thickness) of irradiated~     carotid artery walls and compare this to unirradiated arteries. There are many other causes~     for thickening of arteries (such as high blood pressure, high cholesterol levels and~     diabetes) and these may affect the ability to measure the effect of radiotherapy change to~     the artery wall. In order to address this, it is ideal to look at this process in patients~     who have only had one side of their neck treated and use the other side as a comparison. The~     study will also be looking for earlier signs of radiotherapy-related changes, such as~     stiffening of the artery wall, inflammation in the artery wall (a very early sign of~     radiotherapy-related change) and some markers in the blood that may indicate that this~     process is taking place.~      The null hypotheses of this study are:~        -  In irradiated carotid arteries, the mean intimal-medial thickness will be the same~          compared to unirradiated arteries.~        -  Serum biomarkers will not be elevated in radiation-induced carotid atherosclerosis.~        -  Development of radiation-induced carotid atherosclerosis is not affected by risk factor~          modulation (Aspirin, HMGCoA reductase inhibitors, smoking cessation).~        -  There is no difference in carotid arterial wall strain in irradiated carotid arteries~          versus unirradiated carotid arteries.~        -  Microbubble ultrasound will not be able to detect Inflammation in the carotid arteries~          as an early marker of atherosclerosis.~   "
115119|NCT02060630|"~     This study will compare the effectiveness of best available surgical treatment with best~     available endovascular treatment in adults with critical limb ischemia (CLI) who are eligible~     for both treatment options.~   "
115187|NCT02059746|"~     This is an ancillary study to the JUMODA (National Prospective and Comparative Study on the~     Mode of Delivery of Twins) study: please see NCT01987063.~      The main objective of this study is to investigate the role of the mode of delivery (vaginal~     versus cesarean) as a risk factor for the occurrence of urinary incontinence at 3 months~     post-delivery in primiparous women delivering twins after 34 weeks of pregnancy.~   "
115120|NCT02060617|"~     Recent research has shown that classifying patients with low back pain into treatment~     subgroups results in better improvements than treating all patients with low back pain the~     same. However, physical therapists may use different types of information to determine how to~     classify their patients. One method uses patient characteristics that have been shown by~     research to predict good results from a certain type of treatment. Another method uses~     specific impairments that the physical therapist identifies in a clinical exam to determine~     which treatment to provide. It is not currently known if one of these methods is better than~     the other. The purpose of this study is to determine if research-based classification or~     impairment-based treatment is more effective for treating patients with low back pain that~     has lasted less than 90 days in terms of improvements in pain and disability. The results of~     this study may help reduce the high financial cost associated with low back pain.~   "
115121|NCT02060604|"~     The addition of an anti-inflammatory agent could be a valid option for controlling choroidal~     neovascularization, as simply inhibiting VEGF addresses neither the multifactorial~     pathogenesis of choroidal neovascularization nor the underlying cause of VEGF production.~   "
115122|NCT02060591|"~     The Investigators aim to study the efficacy of Exparel as compared to Marcaine, taking into~     account pain control, narcotic consumption, narcotic-related side effects, outcomes measures,~     and patient satisfaction. Moreover, the Investigators plan to perform cost-benefit analysis~     to evaluate whether use of Exparel decreases analgesic consumption, duration of hospital stay~     and the need for physical therapy postoperatively, therefore, offsetting its higher price in~     comparison with Marcaine.~   "
115123|NCT02060578|"~     Cancer is the second cause of over-one-year-old children mortality after accident. Survival~     rate is more than 70%, but in some cases, curative treatments are not sufficient and~     palliative support is implemented for those children in end of life.~      Pediatric guidelines about the place of end-of-life care are varied. On European scale, home~     is recommended (IMPaCCT study, 2007). In France, the 2008-2012 palliative care development~     program recommended home or initial hospital care unit. This program also supports~     implementation of mobile team rather than specific hospital units.~      In Brittany, a pattern of regional palliative care resource team has been implemented since~     2005. In oncology, further to the guidelines, end-of-life place of care is often discussed~     several times for each case. Sometimes occur a lot of returns between home and hospital,~     psychological difficulties, and difficulties to offer adapted care conditions. Finally, less~     than 30% of children in palliative care decease at home.~      The primary objective is to identify main determinants of the place of palliative care in~     pediatric oncology.~      The secondary objective is to clarify the factors of change comparing to the initial planned~     place.~      Intervention :~      Questionnaire completed by the parents Interview with the parents and the psychologist~     (University Rennes 2)~      Number of subjects is : Parents of 68 to 93 children who died from cancer after a palliative~     phase, that means 136 to 186 parents.~      Expected results and perspectives :~      Using both quantitative and qualitative methods, expected results are the followings:~        -  Identification of the objective and subjective factors, which influenced the decision of~          the place of care.~        -  Determination of the factors of change comparing to the initial planned place.~      Once identified, main factors could be the ones to pay attention to in order to help for~     initial decision, better anticipation of change of place and better guidance of palliative~     care organization wherever, at home or in hospital.~      Results would be new information for research on palliative care for children but also for~     adults.~      Finally, this work is part of an improving approach of palliative care, related to the~     development of open-care hospital networks. We can expect some public health impacts with new~     arguments to help for complementary recommendations.~   "
115124|NCT02060565|"~     The aim of this retrospective and prospective study is to evaluate the 20-year prognosis~     value of non-invasive methods for the diagnosis of chronic liver disease for predicting~     survival and complications of cirrhosis.~   "
115125|NCT02060552|"~     The aim of study was to assess the efficiency and safety of oral IL-1βinhibitor in~     combination with urate lowering therapy on joint pain intensity,urate control, global~     assessments of disease activity, self-monitored gouty acute flare times, inflammatory markers~     and symptoms improving related life quantity in gouty patients.~   "
115126|NCT02060539|"~     To obtain subjective and objective feedback on the clinical performance of Biofinity lenses~     after at least two weeks daily wear in existing contact lens wearers compared with their~     habitual lenses.~   "
115127|NCT02060526|"~     Sanfilippo syndrome Type A, or Mucopolysaccharidosis (MPS) IIIA, is a rare lysosomal storage~     disease caused by deficiency of the enzyme heparan N-sulfatase (sulfamidase). In the absence~     of this enzyme, there is an accumulation of the glycosaminoglycan, heparan sulfate, resulting~     in progressive neurodegeneration. Symptoms are usually first noted in the 1st or 2nd year of~     life, although definitive diagnosis is often delayed, with an average age of diagnosis of 4.5~     years. The disease is characterized by developmental delays initially, followed by~     neurological developmental arrest, then regression. These developmental deficits are~     typically associated with severe behavioral disturbances. Patients have a significantly~     reduced lifespan, with few surviving beyond the 2nd or 3rd decade.~      The purpose of this study is to evaluate the safety and efficacy of recombinant human~     heparan-N-sulfatase (rhHNS) in pediatric patients with Early Stage Mucopolysaccharidosis Type~     III A Disease.~   "
115128|NCT02060513|"~     Military service members and the U.S. veteran population face a growing and serious health~     threat: widespread antibiotic resistance resulting from resistant bacteria and a dwindling~     pipe-line of sufficiently potent antibiotics. Infections with antibiotic resistant bacteria~     are increasing significantly. They cause major complications and mortality, and drive up~     healthcare costs. Powerful but non-targeted antibiotics, while in widespread use, can~     actually pressure bacteria to develop resistance.~   "
115129|NCT02060500|"~     Gastro-Esophageal Reflux is a commonly encountered problem in infants. After failure of~     medical therapy, many children are referred for surgical intervention. Techniques have~     evolved over the last 50 years; however, benefits in children remain the center of debate in~     many surgical forums. This is primarily owing to the high incidence of recurrence of reflux~     and need for revisions later in life. Some clinicians theorize that the pathophysiology of~     reflux in infants is different from that of the population at large, and that the traditional~     operation may not be the best suited for this patient population. We propose a study to test~     an alternative plication technique for modifying the gastro-esophageal junction at the Angle~     of Hiss. By plicating the cardia of the stomach, we hypothesize that we will create a valve~     which will limit reflux without disrupting the diaphragmatic crura, thus reducing the~     incidence of recurrent hiatal hernia and limiting the incidence of fundoplications which are~     too tight.~   "
115130|NCT02060487|"~     This is a blinded study in adult patients with PAH evaluating the relative effects of~     sildenafil on mortality when administered at the three doses (80 mg, 20 mg or 5 mg, all three~     times per day [TID]). In addition, the relative effects on clinical worsening and 6-minute~     walking distance (6MWD) will be assessed.~   "
115131|NCT02060474|"~     This therapeutical trial will be conducted in patients with the Allan-Herndon-Dudley Syndrome~     (AHDS), which is mutations in MCT8.~      MCT8 is a thyroid hormone (TH) transporter which is crucial for the transport of TH from the~     blood into different tissues. Dysfunction of MCT8 results in a lack of TH (hypothyroidism) in~     tissues that depend on MCT8 for TH uptake. This local hypothyroidism in the brain of these~     patients causes severe psychomotor retardation.~      In addition, TH serum parameters are highly abnormal in AHDS: high T3, low T4 and normal TSH~     levels. The high serum T3 levels cause local hyperthyroidism in tissues that do not depend on~     MCT8 for cellular transport of TH, resulting in a low body weight and reduced muscle mass.~      Currently, no adequate treatment is available for the AHDS. A T3 analog that does not depend~     on MCT8 for its cellular entry could, at least partially, restore the abnormalities found in~     AHDS. Several in vivo, in vitro and animal studies have shown that the T3 analog Triac is a~     very promising candidate:~        1. Triac binds to the same TH receptors as T3;~        2. Cellular uptake of Triac does not depend on functional MCT8. Hence, in AHDS patients~          Triac will also be available in tissues that require functional MCT8 for TH uptake, e.g.~          the brain;~        3. In vitro studies have shown that neuronal cells differentiate equally well in the~          presence of either Triac or T3;~        4. In Mct8 deficient mice, Triac is taken up by the brain and suppresses serum TSH levels;~          consequently, serum T3 and T4 levels were lowered;~        5. Triac is the treatment of choice in patient with the resistance to thyroid hormone (RTH)~          syndrome. Patient with RTH have high serum TSH and thyroid hormone levels, which shows~          strong similarities to the profile found in AHDS patients; the longstanding experience~          with Triac in RTH indicates its safety and tolerability .~      Thus, Triac treatment could result in normalization of the abnormal serum TH values in AHDS~     patients. Furthermore, Triac could replace the function of T3 in tissues that depend on MCT8~     for TH uptake (e.g. brain).~      The current trial will investigate if Triac treatment in ADHS patients~        1. reduces the toxic effects of the high T3 levels~        2. restores the local TH deficiency in brain.~   "
115132|NCT02060461|"~     The objective of this study is to evaluate the visual outcome, accuracy, predictability and~     complications of LASIK flap creation using the Alcon Wavelight FS200 Femtosecond laser and~     compare these results to those obtained using current IntraLase FS60 Femtosecond laser. The~     primary outcome to be evaluated is the flap thickness accuracy.~   "
115133|NCT02060448|"~     The overall aim of this study is to begin establishing an effective treatment for individuals~     who engage in non-suicidal self-injury (NSSI), as there are currently no evidence-based~     treatments that directly target this problematic behavior. Existing treatments that have~     demonstrated initial promise in reducing NSSI consist of many skills embedded in complex~     programs; therefore, the skill(s) responsible for improvements in NSSI are not clear.~     Procedures that focus on one's emotions, particularly that aim to increase emotional~     awareness and engagement in cognitive reappraisal (i.e., a way of thinking that lessens~     emotions), may be critical in effective NSSI treatment. The specific goals of this study are~     to investigate the effects of two specific emotion-focused treatment elements on NSSI.~     Participants will be ten individuals who meet the proposed Diagnostic and Statistical Manual~     for Mental Disorders, 5th edition (DSM-5; American Psychiatric Association) criteria for NSSI~     disorder and engage in NSSI to reduce or escape from negative emotions. Two core modules of~     the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al.,~     2011) will be adapted and delivered with the aim of reducing participants' non-suicidal~     self-injurious thoughts and behaviors. Each treatment module will consist of four 50-minute~     individual weekly sessions of emotion awareness training or cognitive reappraisal. The study~     will use a single-case experimental design, and phase change will be determined based on each~     participant's changes in non-suicidal self-injurious thoughts and behaviors.~   "
115134|NCT02060435|"~     The investigators analyzed clinical outcome in DLBCL patients according to age group to~     define the impact of EBV status on the clinical outcome.~   "
115135|NCT02060422|"~     Psychological problems are prevalent among patients with drug-resistant epilepsy. The~     bi-directional interaction between psychological well-being and seizure have been recognized~     in recent years. Reduction of psychological stress has the potential to improve seizure~     manifestation.~      The present study uses an assessor-blinded prospective randomized controlled trial to~     evaluate the efficacy of a mindfulness-based psychotherapy and an attentional-placebo social~     support on improving psychological well-being, seizure control and cognitive performance~     among adult patients with drug-resistant epilepsy.~   "
115136|NCT02060409|"~     In the era of hypomethylating agent in MDS treatment, the investigators aimed to investigate~     the prognostic impact of mutations in spliceosome machinery genes (SRSF2, U2AF1, and ZRSR2)~     on the outcomes of 1st line decitabine treatment in MDS.~   "
115137|NCT02060396|"~     This study in healthy volunteers is the first step in developing a collaborative research~     program, which seeks to test the hypothesis that chemopreventive effect of acetylsalicylic~     acid (ASA) on colon cancer is due predominantly to its antiplatelet effect.~      The following features of the clinical evidence are consistent with the platelet-mediated~     hypothesis:~        1. The apparent saturability of the chemopreventive effect of ASA at low doses given once~          daily, found in long-term analyses of cardiovascular and adenoma recurrence randomized~          clinical trial, as well as in the vast majority of observational studies performed in~          different settings and with different methodology. A remarkably similar saturability of~          the cardioprotective effect of low dose ASA given once daily is explained by the~          irreversible nature of cyclooxygenase (COX)-1 inactivation in platelets, and limited~          capacity of human platelets for de novo protein synthesis.~        2. Given the short half-life of ASA in the human circulation (approximately 20 min) and the~          capacity of nucleated cells to resynthesize the acetylated COX-isozyme(s), it seems~          unlikely that a nucleated target could be suppressed throughout the 24-h dosing~          interval.~        3. One of the cardiovascular randomized clinical trial (Thrombosis Prevention Trial) in~          which the chemopreventive effect of ASA was detected on long-term follow-up, involved~          the administration of a controlled-release formulation of ASA (75 mg) with negligible~          systemic bioavailability.~        4. Enhanced platelet activation and thromboxane (TX)A2 generation in vivo has been~          demonstrated in patients with colorectal cancer and in Familial Adenomatous Polyposis~          patients.~      So, the main objective of this study is to assess the extent of acetylation at serine-529 of~     platelet COX-1 after the 1st and 7th dose of low-doseof enteric-coated ASA 100 mg daily.~     Changes of this novel biomarker of ASA action will be correlated to other known parameters of~     ASA PK and PD: i) Tmax, Cmax and AUC of ASA and salicylate in the peripheral circulation~     after oral dosing; ii) time to obtain the maximal antiplatelet effect by ASA and its~     persistence throughout the dosing interval as assessed by measuring the inhibition of~     platelet COX-1 activity in whole blood ex vivo, the inhibition of platelet aggregation in~     whole blood ex vivo and the inhibition of the systemic generation of TXB2.~   "
115138|NCT02060383|"~     The study aims to demonstrate that pasireotide-induced hyperglycemia can be effectively and~     safely managed in majority of patients, including those with diabetes at start of pasireotide~     treatment.~   "
115139|NCT02060370|"~     The goal of this clinical research study is to learn more about the safety of giving~     sunitinib to patients with metastatic kidney cancer for 2 weeks followed by 1 week in which~     they receive no drug. Researchers want to learn more about the side effects of the drug and~     the effects of a different dosing schedule.~   "
115140|NCT02060357|"~     The aim of this study is a comparative evaluation of re-endothelailisation of the Integrity~     Resolute zotarolimus eluting stent (Medtronic) and of the Promus Element erolimus eluting~     stent (Boston Scientific), in patients with diabetes.~      We plan to compare endothelial coverage and neointimal proliferation using OCT and compare~     this data to published results from conventional stents.~   "
115188|NCT02059733|"~     This study will compare the brain uptake of 18F- DTBZ in 20 patients with PD, 20 patients~     with MSA, 20 patients with PSP, 20 patients with CBS, and 20 patients with VaP, 20 patients~     with ET, and 10 patients with DT.~   "
115142|NCT02060331|"~     In our experience, women with severe pelvic organ prolapse (POP) frequently have bothersome~     nocturia. The International Continence Society (ICS) defines nocturia as having to wake at~     night one or more times to void. Though some of this nocturia may be secondary to obstructed~     bladder emptying, the investigators hypothesize that in some women compression of the~     bilateral ureters due to prolapsed pelvic organs during the day and subsequent relief of that~     prolapse while the patient lays supine overnight results in nighttime post-obstructive~     diuresis (inability to concentrate urine) and resultant large nighttime urine volumes and~     nocturia. Previous case reports have proposed that vaginal and uterine vault prolapse causes~     obstruction due to descent of the bladder floor which leads to compression of the bilateral~     ureters between the uterus and the borders of the genital opening. No large prospective~     studies, however, have evaluated the possible impact of this phenomenon on patients or the~     possible post-operative changes following surgical correction of POP.~      Using the Nocturnal Enuresis, and Sleep interruption Questionnaire (NNES-Q), voiding diaries,~     and urine studies, the investigators aim to evaluate the pre-operative and post-operative~     voiding habits and urinary parameters of women with severe pelvic organ prolapse and~     bothersome nocturia who undergo colpocleisis. Colpocleisis is a procedure which surgically~     obliterates the vaginal lumen to treat severe POP in properly counseled patients with >90%~     satisfaction rates. Other treatments offered to women, such as the laparoscopic or open~     sacrocolpopexy, uterosacral ligament suspension, and sacrospinous ligament suspension, also~     offer high rates of success. The investigators aim to determine whether surgical correction~     of severe pelvic organ prolapse, to be defined as either with colpocleisis, laparoscopic or~     open sacrocolpopexy, uterosacral ligament suspension, or sacrospinous ligament suspension,~     results in improvement and/or resolution of nocturia and post-obstructive diuresis.~   "
115143|NCT02060318|"~     Aim: the main aim of this study is to investigate if immune cells (regulatory T-cells, Th17~     cells and other immune cell types) or biomarkers can be used to predict the response or lack~     of response to treatment with Infliximab. If so, characteristics of the immune cells may also~     unveil the mechanisms behind lack of response to Infliximab.~      Design: a prospective, observational study with three arms. In the treatment group, 35~     patients with Crohn's disease about to start Infliximab-treatment are recruited. They have~     blood samples drawn at day 1 before first treatment, after 6 week, and again after 22 weeks~     of treatment. 12 healthy volunteers serve as a control group. Controls are only investigated~     once. All treatment and follow-up are according to national guidelines, and data from this~     study is not used by the clinicians.~      Methods: the number of regulatory T-cells and pro-inflammatory T-cells (Th17 cells) is~     investigated using flow cytometry. From plasma and serum samples, various proteins~     (biomarkers), such as transforming growth factor beta (TGF-beta) and tumour necrosis factor~     alpha (TNF-alpha), are measured using immunoassays. Patient data (demographics and medical~     history) are extracted from various registries.~   "
115144|NCT02060305|"~     Primary Objective The efficacy of intra-articular bevacizumab injection for secondary~     prevention of recurrent hemarthroses for hemophilia patients who has had target joints with~     chronic synovitis. The safety profiles of intra-articular bevacizumab injection for~     hemophilia patients.~      Study Population Adult hemophilia patients who have had one or more target joints with~     chronic synovitis and recurrent hemarthroses.~      Investigational therapy: Intra-articular injection of Bevacizumab (20 or 40 mg/ 0.8 or 1.6~     ml/ dose) every month (28 days) for up to 4 months, depending on the improvement of target~     joint bleeding.~      Study Design The estimated study period is between Jan 2014 and Dec 2015. Totally 10 joints~     will be enrolled for this pilot study. Before enrollment, the joint(s) will be evaluated for~     their severity both clinically (by 10-point Pain Score, range of motion for the target joint,~     and World Federation of Hemophilia Score) and by MRI (using the compatible MRI scales~     developed by International Prophylaxis Study Group [IPSG]). Intra-articular injection of~     bevacizumab will be administered, after prophylactic factor supplementation, every month for~     up to four injections. In the first four patients, 20mg of bevacizumab will be administered.~     If there are no Gr 3 or Gr4 dose-limiting toxicities, bevacizumab dose will be escalated to~     40mg in the other 6 patients. Before every procedure, the plasma and the synovial fluid~     samples will be collected for VEGF quantification for the correlative biomarker study. After~     completing the protocol treatment, the efficacy parameters as well as the safety profiles~     will be evaluated.~   "
115145|NCT02060292|"~     Cognitive impairment is a known consequence of cerebral small-vessel disease. Moderate to~     severe cognitive impairment has been shown in up to 60% of certain individuals with COPD and~     is likely to profoundly influence an individual's ability to manage their disease.~      In addition to cerebral small vessel damage and cognitive dysfunction, other organs such as~     the heart, kidneys, and retina are likely to be susceptible to small-vessel damage in COPD.~     Several large population studies have shown that COPD is a significant independent risk~     factor for myocardial infarction, with the effect most marked in early, mild disease.~      We propose to compare non-invasive MR brain imaging of white matter microstructure (diffusion~     tensor), cerebral perfusion (arterial spin labelling) and accumulated cerebral small vessel~     disease (cerebral microbleeds), in COPD patients to smokers without COPD. In addition we plan~     to explore mechanisms of cerebral small vessel disease in COPD by looking for associations~     between arterial stiffness, end organ vascular damage and cognitive function.~   "
115146|NCT02060279|"~     This is a pilot study of children between the ages of 8 to 11 years of age who are obese and~     participating in an intense family based intervention with a family-focused multi-component~     lifestyle intervention. In addition, a beta-carotene supplement will be administered to~     randomized participants.~   "
115147|NCT02060266|"~     This trial is conducted in Europe. The aim of the trial is to investigate the absorption,~     metabolism and excretion after a single subcutaneous dose of [3H]-semaglutide in healthy male~     subjects.~   "
115148|NCT02060253|"~     This phase I trial studies the side effects and best dose of ganetespib when given with~     paclitaxel, trastuzumab and pertuzumab in treating patients with human epidermal growth~     factor receptor 2 positive (HER2+) metastatic breast cancer (MBC).~   "
115149|NCT02060240|"~     The purpose of the study is to see if a twelve-week exercise intervention in overweight or~     obese subjects with pre-diabetes or early disease course type 2 diabetes can lead to improved~     skeletal muscle capillary blood flow by improving substances that dilate blood vessels and~     result in improved insulin sensitivity.~   "
115150|NCT02060227|"~     The primary research question is to determine whether patients who undergo a stabilization of~     the shoulder using a novel decision-making algorithm (ISIS Score) have improved~     disease-specific quality of life at 1 year post-operatively, as measured by the Western~     Ontario Instability Index (WOSI) compared with patients who undergo stabilization using a~     conventional decision-making algorithm. Secondary outcomes include the American Shoulder and~     Elbow Surgeon's (ASES) score, and difference in recurrence rates of dislocation between the~     two decision-making algorithms.~   "
115189|NCT02059720|"~     A multicentre, prospective, open-label clinical study, including a randomized controlled~     study in low or intermediate-risk group patients, and a cohort study of maintenance treatment~     with decitabine after ASCT.~   "
115151|NCT02060214|"~     Urinary urgency is the key symptom of overactive bladder (OAB). A critical barrier in~     understanding OAB is the lack of a method to separate urgency that derives directly from~     bladder filling or what we term tension sensor output and urgency that derives from~     abnormal brain interpretation. The central hypothesis is that measureable biomechanical~     parameters can directly affect the output (urgency) of the detrusor tension sensor.~      The development of novel cystometric tests for the improved diagnosis and treatment of OAB~     and for the potential identification of novel mechanistic targets in the pathophysiology of~     OAB.~   "
115152|NCT02060201|"~     The purpose of this study is to demonstrate the bioequivalence (BE) of Saxagliptin and~     Dapagliflozin from a 2.5-mg Saxagliptin/5-mg Dapagliflozin FDC tablet after oral~     administration relative to 2.5-mg Saxagliptin and 5-mg Dapagliflozin tablets administered~     orally together in the fasted state and to demonstrate the BE of Saxagliptin and~     Dapagliflozin from a 5-mg Saxagliptin/10-mg Dapagliflozin FDC tablet after oral~     administration relative to 5-mg Saxagliptin and 10-mg Dapagliflozin tablets administered~     orally together in the fasted state. Demonstrating bioequivalence refers to showing that the~     FDC tablet and co-administration of the individual components yield similar blood~     levels/concentrations of the drug and are handled by the body similarly.~   "
115153|NCT02060188|"~     The purpose of this study is to examine if Nivolumab by itself, or Nivolumab in combination~     with other anti-cancer drugs, will result in meaningful tumor size reduction, in patients~     with colon cancer that has come back or has spread, and who have a specific biomarker in~     their tumors.~   "
115154|NCT02060175|"~     We will compare the stent coverage at 3 months by optical coherence tomography (OCT) between~     the Cilotax and DESyne drug-eluting stents (DES). The extent of the strut uncoverage has not~     been evaluated yet for both the Cilotax and DESyne and we first sought to decide the~     reference intervals using 40 samples (total 44 patients for each group considering 10%~     drop-out rate) as the pilot study.~   "
115155|NCT02060162|"~     This is a prospective HIV cohort that aims to establish causes of liver disease among~     HIV-infected individuals in Zambia, including viral hepatitis and alcohol.~   "
115156|NCT02060149|"~     The mortality of pneumonia with extensively drug resistant Acinetobacter baumannii (XDRAB) is~     still high, even if these patients received certain strong anti-infection treatment such us~     the combination of cefoperazone-sulbactam (C/S) and minocycline. Health airway lining fluid~     is mildly alkaline but airway acidification usually appears for the infection of XDRAB. The~     hypothesis is offered that the biologic activity of XDRAB might be inhibited if the~     circumstance including pH is changed. In the vitro study we observed that the inhibit effect~     of antibiotics on XDRAB growth was improved significantly by alkaline solution within the~     scope of physiology. So the aim of this clinical study is to explore the effects of~     nebulization of alkaline Solution on C/S plus minocycline on the pneumonia with XDRAB.~   "
115157|NCT02060136|"~     Urinary diaries have proven to be beneficial in assessing lower urinary tract symptoms~     (LUTS), however they have not achieved widespread acceptance. The likely reason is the fact~     that the pen and paper diaries are labor intensive for both patient (need to carry a pen and~     paper and record each event) and doctor (need to transfer, summarize and analyze the data).~      Hypothesis: Electronic voiding diary, would automate the recording and analysis of data,~     expedite the process, improve its accuracy and cost effectiveness.~      Electronic recording of lower urinary tract symptoms (SUF) uses wireless phone and web based~     technologies to record LUTS remotely and store the data on a secure website which can be~     accessed by the doctor or patient whenever needed. The goal of this study was to compare its~     validity and reliability to the traditional micturition chart (MC) recording method - the~     current gold standard where the patient records the time of micturition and degree of urgency~     using a pen and paper.~   "
115158|NCT02060123|"~     The purpose of this study is to evaluate the effect of a qigong intervention program on~     telomerase activity in Chinese women with a history of intimate partner violence.~   "
115159|NCT02060110|"~     The registry is designed to determine the long-term mortality and morbidity benefit as a~     result of Cardiac Resynchronization Therapy with Defibrillation (CRT-D) vs. Implantable~     Cardioverter Defibrillator (ICD) therapy in the MADIT-CRT study patient population. The~     registry will collect data on patients that previously participated at MADIT-CRT sites within~     Europe through five years of participation from their orginal enrollment in the MADIT-CRT IDE~     study.~   "
115160|NCT02060097|"~     Photoaging is caused by the superposition of chronic ultraviolet (UV)-induced damage on the~     intrinsic aging process, and accounts for the majority of age-associated changes in skin~     appearance. Reactive oxygen species (ROS) likely contribute to this process. Strategies~     utilizing endogenous skin antioxidants as well as plant-derived or synthetic compounds have~     been examined.~      Cocoa beans fresh from the tree are exceptionally rich in polyphenols, such as flavanol, and~     have a higher antioxidant capacity. The present study is designed to investigate the effects~     of long-term intake of a product rich in cocoa flavanols on facial wrinkles, hydration,~     elasticity and photosensitivity.~   "
115161|NCT02060084|"~     Gut of newborn preterm is sterile, immediately by the mother and the surrounding environment~     from microbial colonization. As the effects of diet, intestinal flora is rapidly changed.~     Preterm children significantly delay in the establishment of normal flora,during~     hospitalization because of no breastfeeding, use of antibiotics, enteral feeding delay,~     combat disease and other factors. In this study, hospitalized preterm children for the study,~     the prospective randomized double-blind controlled study, to find oral intestinal~     bifidobacteria and lactobacilli and bifidobacteria subspecies composition and distribution,~     and further show intestinal bacteria in premature children case group.~   "
115162|NCT02060071|"~     There is a correlation between endothelial progenitor cells (stem cells) and stenosis of the~     aortic valve.~   "
115163|NCT02060058|"~     The aim of this study is to explore the efficacy and safety of boceprevir -based triple~     therapy to rescue HCV genotype 1 (HCV GT1)/HBV dually infected patients refractory to~     previous peginterferon (PEG-IFN) plus ribavirin (RBV) combination therapy.~   "
115164|NCT02060045|"~     The objective of the investigators work was to evaluate the impact of 4 sequentially~     implemented measures for preventing VAP in a major heart surgery ICU. The measures were a~     specific training program, aspiration of subglottic secretions (ASS), introduction of an~     inclinometer to improve the semirecumbent position, and reinforcement of oral care with~     chlorhexidine.~   "
115165|NCT02060032|"~     Background: Statins are the recently evolved agents that aid in periodontal regeneration and~     ultimately attaining periodontal health. Atorvastatin (ATV) and Simvastatin (SMV) are~     specific competitive inhibitors of 3-hydroxy-2-methyl-glutaryl coenzyme A reductase. The~     present study was designed to evaluate and compare the effectiveness of 1.2% ATV, and 1.2%~     SMV as an adjunct to scaling and root planing (SRP) in the treatment subjects with chronic~     periodontitis.~      Methods: Ninety six subjects were categorized into three treatment groups: SRP plus 1.2% ATV,~     SRP plus 1.2% SMV and SRP plus placebo. Clinical parameters; full mouth plaque index (PI),~     modified sulcus bleeding index (mSBI), probing depth (PD), and relative attachment level~     (RAL) were recorded at baseline before SRP and at 3, 6 and 9 months. Percentage radiographic~     defect depth reduction was evaluated using computer-aided software at baseline, 6 months and~     9 months.~   "
115166|NCT02060019|"~     This study is designated to evaluate the pharmacokinetic interactions of amlodipine besylate,~     valsartan and rosuvastatin in healthy male volunteers.~   "
115167|NCT02060006|"~     Background: Non-Steroid Anti-Inflammatory Drugs (NSAIDs) reduce pain and inflammation by~     inhibiting cyclooxygenase, an enzyme in the pathway for formation of prostaglandins and~     thromboxane. Prior studies have proven the role of ibuprofen (an NSAID) in modulating lung~     injury and decreasing pulmonary damage in cystic fibrosis. While there has been an intense~     effort by the scientific community to define the best treatment strategies for tuberculosis~     immune reconstitution inflammatory syndrome (TB-IRIS), to our knowledge there is no available~     study evaluating preventive strategies using anti-inflammatory agents for TB-IRIS, a highly~     morbid complication in HIV-infected TB patients initiating antiretroviral therapy (ART).~      Design and Methods: We propose to conduct a single center double-blind placebo-controlled~     randomized trial to investigate the efficacy of daily self-administered Meloxicam (a NSAID)~     versus placebo for prevention of Tuberculosis associated Immune Reconstitution Inflammatory~     Syndrome (TB-IRIS). A total of 150 HIV-infected adults who are treated for Tuberculosis for~     at least 2 weeks and about to initiate HIV treatment at Brewelskloof Hospital, Worcester, and~     Tygerberg Teaching Hospital, Cape Town, will be randomized to one of the following~     treatments: Meloxicam 7.5 mg tablet once-a-day, the experimental arm, versus Placebo tablet~     once-a-day, the control arm, for 8 weeks. All patients will be followed up for 12 months.~     Primary efficacy outcome: The decrease of the incidence of paradoxical TB IRIS by at least~     20%; Primary safety outcome: The proportion of patients who temporarily or permanently~     discontinue Meloxicam due to any adverse event (e.g. dyspepsia or gastro-intestinal upset).~     Secondary outcomes are: 1) the proportion of patients in each arm with the following~     indicators of TB-IRIS severity/quality of life (QOL) (degree of pain or discomfort >III,~     presence of local or disseminated suppuration/abscess of any site, unscheduled clinic visits,~     hospitalizations, missed more than a day at work, etc; 2) The incidence of other types of~     IRIS (e.g. Kaposi Sarcoma or cryptococcal meningitis).~      This study will provide important and novel data on the feasibility and efficacy of using a~     cheap, widely available NSAID used in both developed and developing countries, as a~     preventive intervention for TB-IRIS that could be quickly put into practice if proven to be~     effective~   "
115168|NCT02059993|"~     Obstructive sleep apnea(OSA) is an important identifiable cause of hypertension. Previous~     study has suggested that OSA significantly increases cardiovascular morbidity and mortality,~     especially in patients with pre-existing cardiovascular disease.The standardized treatment of~     moderate/severe OSA is continuous positive airway pressure (CPAP). Most of short-term trials~     indicated that CPAP treatment reduced BP in patients with OSA. But relevant studies have a~     relative short duration with only but few more than one year. In our opinion, they are not~     sufficient to detect the real effect of CPAP on reduction in BP. Besides, the impact of OSA~     on metabolic disorder is still unclear.We hypothesized that long-term CPAP treatment could~     reduce blood pressure and improve metabolic disorder in patients with coronary heart disease~     (CHD)and OSA.~   "
115169|NCT02059980|"~     Obsessive-compulsive disorder (OCD) and its related disorders (e.g., trichotillomania) are~     characterized by the marked difficulty in inhibiting unwanted or inappropriate responses.~     There is compelling evidence that poor response inhibition is a core cognitive feature of OCD~     and its related disorders, but no effective intervention exists that directly attempts to~     address this problematic cognitive deficiency. This study will examine the feasibility and~     clinical utility of a computerized cognitive training program designed to improve response~     inhibition among individuals diagnosed with OCD or trichotillomania.This training program~     offers systematic practice of response inhibition in the form of a 40-level computer game.~     Individuals with these conditions will be randomized to either 8 sessions of (a) computerized~     response inhibition training (RIT) or (b) placebo computer training (PLT). We hypothesize~     that RIT will outperform PLT in improving response inhibition capabilities and reducing~     relevant clinical symptoms. In sum, this project is expected to generate important knowledge~     to guide the development of effective computer-based treatment approaches that may help~     reduce critical problems of existing treatments such as suboptimal patient retention and~     treatment under-utilization, thereby improving overall treatment response rates among~     individuals suffering from OCD and related conditions.~   "
115170|NCT02059967|"~     This phase I trial studies the side effects and best dose of image-guided adaptive radiation~     therapy using active breathing control when given together with chemotherapy and simultaneous~     integrated boost in treating patients with stage IIA-IIIB non-small cell lung cancer that~     cannot be removed by surgery. Image-guided adaptive radiation therapy aims radiation therapy~     right at the tumor so that higher radiation doses can be given without causing bad side~     effects. Giving these higher doses may help control the tumor better. Breathing causes organs~     and tissues, including the tumor, to move within the chest. Active breathing control may~     reduce the volume that needs to be treated. Drugs used in chemotherapy, such as paclitaxel~     and carboplatin, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. Giving image-guided adaptive radiation therapy~     using active breathing control with chemotherapy and simultaneous integrated boost may be an~     effective treatment for non-small cell lung cancer.~   "
115171|NCT02059954|"~     Hysterectomy for benign indication is one of the most common surgical procedures in women.~     Numerous reviews and guidelines recommend the vaginal approach for benign hysterectomy, but~     the proportion of laparoscopic (and robotic) hysterectomies is increasing.~      This study will compare a range of clinical and subjective outcomes of vaginal vs. total~     laparoscopic hysterectomy. Outcomes include operating time, postoperative recovery, return to~     work as well as cosmesis, quality of life and sexual health.~   "
115172|NCT02059941|"~     Management of intracranial hypertension (ICH) in patients with severe traumatic brain injury~     (sTBI) is crucial to their survival and optimal recovery. The evidence-based Guidelines for~     the Management of Severe Traumatic Brain Injury, 3rd Edition recommends use of intracranial~     pressure (ICP) monitors to assess ICH and guide intervention. Unfortunately, only a small~     percentage of the world has the resources and capability to routinely monitor ICP.~      The objective of this proposal is to create and test guidelines for the treatment of severe~     TBI in the absence of ICP monitoring.~   "
115173|NCT02059928|"~     In emergency situations, access to the venous system is essential in order to administer~     fluids and medication and to monitor patients. When peripheral veins are difficult to access~     or the patient's condition requires certain medications, or monitoring, central venous~     catheters (CVC) are inserted. CVC placement introduces a much higher level of risk compared~     to peripheral catheters. The technique of intraosseous (IO) infusion has been used by~     healthcare professionals for several decades, but recently has gained wide popularity in the~     emergency care settings. This technique allows providers to secure a needle in the bony~     matrix at the ends of long bones (tibia and humerus) and infuse fluids and medications into~     the intramedullary space. The ability to monitor a patient's blood pressure through an~     intraosseous needle is unknown. The primary objective of this study is to describe the~     relationship (ratio) of intraosseous pressure (IOP) values to standard pressure values,~     including systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial~     pressure (MAP), and central venous pressure (CVP).~   "
115174|NCT02059915|"~     To Compare The Bioavailability Of 40 Mg Doses Of Pf-00345439 Modified Formulation K Vs.~     Original Formulation X Under Fed And Fasting Conditions In Healthy Volunteers~   "
115175|NCT02059902|"~     Thermal injury results in one of the most intense and prolonged forms of pain the body can~     experience. Opioid narcotics are the most powerful drugs for acute and chronic pain, and~     their use in the perioperative period has been the mainstay of treatment; although medication~     requirements in burn patients are often underestimated. More medication may not be the~     answer, as relatively large doses of short acting opioids in the operative theater are~     associated with greater postoperative opioid consumption and higher pain scores. Furthermore,~     extensive use of opioids has resulted in the development of by hyperalgesia and allodynia.~     Lidocaine is an amide local anesthetic that has analgesic, anti-hyperalgesic, antiarrhythmic,~     and anti-inflammatory properties. Over the past 25 years, systemic lidocaine has been used~     for perioperative pain management in a variety of surgical procedures. The design of this~     study will examine if lidocaine will reduce the pain scores and narcotic utilization in~     patients undergoing surgical procedures for burn injuries. The intervention group will~     receive a bolus dose of lidocaine followed by a continuous infusion over 24 hours. The~     control group will get an equal volume of saline. The investigators will compare pain scores,~     opioid use, and narcotic equivalents based on body weight and burn surface area (BSA)~     grafted.~   "
115176|NCT02059889|"~     This clinical trial studies diffusion-weighted magnetic resonance imaging (MRI) in~     identifying and localizing tumors in patients with non-small cell lung cancer undergoing~     radiation therapy. Diagnostic procedures such as diffusion weighted MRI may help identify~     where active cancer is to improve the targeting accuracy of radiotherapy. Comparing results~     of diagnostic procedures done before, during, and after radiation therapy may help determine~     how the location and volume of tumors changes over time and predict how the tumor will~     respond to therapy.~   "
115177|NCT02059876|"~     The purpose of this study is to determine the efficacy and safety of dose-dense(biweekly)~     carboplatin and paclitaxel ± trastuzumab as neoadjuvant treatment in early breast cancer.~   "
115178|NCT02059863|"~     A large number of children in developing countries lack access to known effective~     interventions. Almost 9 million die each year before reaching their fifth birthday, and over~     200 million children who survive fail to achieve their full growth or developmental~     potential, trapping them in a cycle of continuing disadvantage. The goal of SPRING,~     Sustainable Programme Incorporating Nutrition and Games, is to develop an innovative approach~     to close this access gap, in two of the worst affected countries India and Pakistan, using~     community based agents. Extensive formative research will be carried out to help ensure that~     the content and approach of the SPRING intervention is feasible, acceptable and~     appropriately targeted. Findings will be reviewed at an intervention development workshop~     with local and international stakeholders and experts, and the agreed intervention piloted~     with a few community based agents and their supervisors. Cluster randomised controlled trials~     will be carried out in each setting to evaluate the impact of SPRING on child growth,~     development and survival. The programme will include process and economic evaluations to~     provide information on the total cost of the intervention and its cost effectiveness, as well~     as development of a framework with lessons learned for implementing SPRING in other~     settings.~   "
115179|NCT02059850|"~     This phase I trial studies the side effects and best way to give NY-ESO-1 specific T cells~     after cyclophosphamide in treating patients with advanced synovial sarcoma or myxoid/round~     cell liposarcoma. Placing a gene that has been created in the laboratory into white blood~     cells may make the body build an immune response to kill tumor cells. Drugs used in~     chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer~     cells, either by killing the cells or by stopping them from dividing. Giving NY-ESO-1~     specific T cells with cyclophosphamide may kill more tumor cells.~   "
115180|NCT02059837|"~     This study is conducted to evaluate its morphologic reproliferating patterns in patients with~     pterygium treated with the excision and conjunctival autograft.~   "
115181|NCT02059824|"~     The purpose of this study is to determine normal eyelid sensation distribution using a~     Cochet-Bonett Aesthesiometer.~   "
115182|NCT02059811|"~     More than two-thirds of US adults with chronic kidney disease (CKD) have uncontrolled~     hypertension. Both hypertension and CKD are major independent risk factors for cardiovascular~     disease, which is the leading cause of death in the US. Fortunately, lowering blood pressure~     to recommended treatment targets not only slows the progression of CKD, but also improves~     cardiovascular outcomes. Controlling hypertension in this patient population, however, can be~     quite challenging. A lifestyle modification that effectively reduces blood pressure in both~     pre-hypertensive and hypertensive adults is the Dietary Approaches to Stop Hypertension~     (DASH) diet.~      The purpose of this pilot study is to (1) determine the extent to which the DASH diet lowers~     blood pressure in hypertensive adults with moderate chronic kidney disease (CKD) (estimated~     glomerular filtration rate [eGFR] 30-59 ml/min/1.73m2) and (2) establish that the DASH diet~     can be safely consumed by this patient population.~   "
115183|NCT02059798|"~     Hypotheses:~      Decompressive surgery of cervical myelopathy will improve bladder function.~      Decompressive surgery of cervical myelopathy will improve sexual function.~   "
115184|NCT02059785|"~     This research is a Randomized, double-blind, placebo-controlled, multicenter clinical study.~     Chinese subjects with Ischemic Stroke.~   "
115193|NCT02059668|"~     The aim of this clinical research project is to validate the prognostic impact of potential~     biomarkers on loco-regional control of locally advanced head and neck cancer after definitive~     or adjuvant radiochemotherapy. The treatment is equal to the standard of care.~      Potential biomarkers from a previous retrospective study will be validated in this~     prospective study.~   "
115194|NCT02059655|"~     The purpose of the study is to establish whether Bimatoprost eye drops are effective in~     reducing proptosis in inactive thyroid eye disease (TED) patients and improving quality of~     life in patients with TED. Current standard NHS treatment/care for inactive TED is artificial~     tears (used as the placebo in this study) or surgery if appropriate.~      The IMP is Bimatoprost eye drops PGF2α (0.03%). This is already licensed eye drops usually~     used for glaucoma. Therefore the current trial's indication is outside its licenced~     indication. The Investigational Medicinal Product (IMP) will be used according to its~     licenced dosage and form. This is the first time that Bimatoprost will be used in the~     treatment of TED~   "
115195|NCT02059642|"~     This study is a multisite, randomized, double-blind, placebo-controlled, phase 2/3 study of~     MG01CI (1400 mg daily) for 6 weeks compared with placebo in a 1:1 ratio of 300 adults with~     ADHD.~   "
115196|NCT02059629|"~     The Eluna Family / Sentus BP Master Study is designed to confirm the safety of the new Eluna~     pacemaker family and the Sentus BP (bipolar) left ventricular lead.~      Furthermore the new wandless RF telemetry function SafeSync and the handling of the Sentus~     lead during implantation will be assessed.~   "
115197|NCT02059616|"~     The purpose of this study is to explore the optimal dose of fixed-dose combination of~     candesartan cilexetil and amlodipine besylate by examining the safety and efficacy of the~     combination therapy compared to each of the monotherapy in patients with essential~     hypertension.~   "
115198|NCT02059603|"~     Background: Our previous study demonstrated that electroacupuncture at Zusanli, Sanyinjiao,~     Hegu, and Zhigou reduces the duration of postoperative ileus and hospital stay after~     laparoscopic colorectal surgery within a traditional perioperative care setting. Recent~     evidence also suggested that a 'fast-track' perioperative program may help accelerate~     recovery after colorectal surgery. As electroacupuncture is simpler to implement and less~     labor intensive, it may be the preferred adjunct therapy if it is proven to be noninferior to~     fast-track program in reducing the duration of postoperative ileus and hospital stay after~     laparoscopic colorectal surgery.~      Objectives: To compare the efficacy of electroacupuncture and fast-track program in reducing~     the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery.~      Design: Prospective, randomized, noninferiority trial.~      Subjects: One hundred sixty-four consecutive patients undergoing elective laparoscopic~     resection of colonic and upper rectal cancer will be recruited.~      Interventions: Patients will be randomly allocated to receive either: (A) electroacupuncture~     with traditional perioperative care; or (B) fast-track program without acupuncture.~      Outcome measures: Primary outcome: time to defecation. Secondary outcomes: duration of~     hospital stay, time of first passing flatus, time to resume diet, pain scores, analgesic~     requirement, morbidity, and medical costs.~      Conclusions: This study will determine if electroacupuncture is noninferior to fast-track~     program in reducing the duration of postoperative ileus and hospital stay after laparoscopic~     colorectal surgery. Electroacupuncture may be the preferred perioperative adjunct therapy to~     laparoscopic colorectal surgery because it is simpler to implement and less labor intensive~     than fast-track program.~   "
115199|NCT02059590|"~     The purpose of this study is to evaluate the pharmacokinetics of 14C-labeled cleavage product~     (BAL8728), in particular the routes of excretion and extent ot metabolism of the cleavage~     product following administration of a single intravenous dose of pyridinylmethyl-14C-labeled~     prodrug isavuconazonium sulfate (BAL8557). In addition, identify the metabolic profile of~     BAL8728 in human plasma, urine and/or feces after a single intravenous dose of~     pyridinylmethyl-14C-labeled BAL8557 and evaluate the pharmacokinetics of BAL8728 and BAL4815.~     Safety and tolerability after a single intravenous dose of pyridinylmethyl-14C-labeled~     isavuconazonium sulfate will also be evaluated.~   "
115200|NCT02059577|"~     70 children and adults with autism spectrum disorders will be enrolled in a 1-year,~     single-blind treatment study. Assessments will be conducted at the beginning and end of the~     study, including measurements of nutritional, metabolic, and digestive status and assessments~     of autism severity and overall functioning. Half of the participants will be randomized into~     a treatment study, and half will be randomized to no changes in their current treatments.~     Treatments will be added in a sequential manner over 12 months, including vitamin/minerals,~     essential fatty acids, carnitine, digestive enzymes, and healthy, gluten-free, casein-free~     diets. A dedicated team of nutritionists, nurses, and physicians will support and monitor the~     participants throughout the study.~      A group of 50 neurotypical children and adults, of similar age and gender, will be included~     for comparison.~   "
115201|NCT02059564|"~     A Phase 1b, Exploratory, Randomized, Partially Single Blinded, Placebo and Open Label~     Controlled, Parallel Group Study to Assess the Effects of HM11260C and an Active Comparator~     on Gastric Emptying and Beta-Cell Response in Subjects with Type 2 Diabetes Mellitus~   "
115202|NCT02059551|"~     Magnetic resonance imaging (MRI) represents a promising technique but can not be used as an~     alternative test to multidetector CT in patients with suspicion of pulmonary embolism (PE)~     due to its low sensitivity and high proportion of inconclusive MRI. The purpose of this study~     is to evaluate diagnostic performances of MRI combined with venous ultrasonography of the~     legs in patients with suspicion of PE.~   "
115203|NCT02059538|"~     Supported by state-of-the-art systems medicine competences including integrative~     computational and functional genomics, the overarching goal of the trial is to investigate~     the impact of qualitative and quantitative changes in the gut microbiota on the pathogenesis~     of cardiometabolic diseases (CMDs) and their associated co-morbidities. A major objective~     will be to translate the clinical and fundamental based discoveries into new diagnosis and~     preventive actions paving the way to novel modes of treatment in the successive stages of CMD~     progression.~   "
115204|NCT02059525|"~     This study is part of the Search for a Treponema pallidum Antigen Test (SeTPAT) project to~     study the proteomic, immunological, serological and clinical changes associated with pre- and~     post-treatment syphilis infection in a way that could ultimately lead to the development of a~     new ELISA and rapid diagnostic test of T. pallidum antigenaemia.~      The general aim of this prospecive observational cohort study is thus to quantify a set of~     target proteins with the highest diagnostic potential for the diagnosis of initial T.~     pallidum infection and T. pallidum persistence. A test which could directly detect the~     presence of T. pallidum antigens could represent a considerable advance over currently used~     tests in the diagnosis of initial syphilis infection, its response to therapy and in the~     diagnosis of syphilis reinfections. This prospective observational cohort study of~     HIV-positive patients with a new diagnosis of syphilis infection will be conducted at the~     HIV/Sexually Transmitted Infections (STI) Clinic at the Institute of Tropical Medicine,~     Antwerp.~   "
132458|NCT01833546|"~     This is a Japanese Phase 1, open-label, and dose-escalating trial of TH-302 as monotherapy in~     subjects with solid tumors and in combination with gemcitabine in subjects with pancreatic~     cancer.~   "
115205|NCT02059512|"~     The purpose of this study evaluate the effect of the method of administration of autologous~     bone marrow mononuclear cells for the duration of of functioning aorto-coronary bypass grafts~     in the surgical treatment of coronary heart disease, to assess the degree of effectiveness~     depending on the method of transplantation (intramyocardial, intracoronary).~   "
115206|NCT02059499|"~     This randomized phase III trial studies imiquimod or fluorouracil to see how well they work~     compared to observation in treating patients with high-grade anal squamous skin lesions who~     are human immunodeficiency virus (HIV)-positive. Biological therapies, such as imiquimod, may~     stimulate the immune system in different ways and stop tumor cells from growing. Drugs used~     in chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. It is not yet known~     whether imiquimod or fluorouracil is more effective than observation in treating high-grade~     anal squamous skin lesions.~   "
115207|NCT02059486|"~     The purpose of this study is to evaluate the impact of the Teen Choice program on reducing~     the rates of unprotected sex of high risk youth in New York.~   "
115208|NCT02059473|"~     The purpose of this project is to compare operative repair of traumatically torn rotator cuff~     tendon with physiotherapy in a randomized prospective study.~   "
115209|NCT02059460|"~     To study the impact of intra and post-operative Terlipressin infusion on the occurrence of~     acute kidney injury after LDLT To investigate perioperative Neutrophil Gelatinase Associated~     Lipocalin (NGAL) changes and study the effect of Terlipressin on NGAL blood levels~   "
115210|NCT02059447|"~     The principal hypotheses to be tested is that Mindfulness Based Cognitive Therapy (MBCT)~     reduces the distressing impact of tinnitus to a significantly greater extent than a waiting~     list control or relaxation therapy.~      This study is a mixed design, with two groups assessed at a number of time points. The~     primary outcome measure will be that of tinnitus distress, and secondary outcomes will be~     taken of psychological distress and tinnitus loudness.~      The outcome measures will be measured first at 8 weeks pre-treatment. All subjects then wait~     for 8 weeks before being randomly allocated to either an 8 week course of Mindfulness-Based~     Cognitive Therapy (MBCT) (Group 1) or an 8 week course of Relaxation Therapy (RT) (Group 2).~     All participants will be assessed at two main time-points (pre and post-treatment). The~     outcome measures will be repeated at 1 and 6 month follow-up points.~   "
115211|NCT02059434|"~     The purpose of this study is to assess the safety and tolerability of single doses of~     LAS190792 administered by inhalation to patients with mild persistent asthma and moderate to~     severe chronic obstructive pulmonary disease (COPD) and also to assess the ability of~     LAS190792 to produce bronchodilation (opening of the airways).~   "
115212|NCT02059421|"~     The purpose of this project is to compare the effectiveness of Johrei therapy (JT) and~     Cognitive-behavioral Therapy for Insomnia (CBT-I) in the treatment of sleep disturbances in~     survivors of critical illness. Subjects will be recruited following discharge from the~     Intensive Care Unit (ICU) and followed for 6 weeks. All subjects will undergo objective~     measurements of sleep quality and duration at baseline and at 6 weeks. Objective measurements~     will be made by portable (home-based) sleep studies and will wear a watch that measures~     sleep. Subjective measurements will be performed by sleep questionnaires: PSQI, Epworth~     sleepiness scale, sleep log, and Stanford Sleepiness Scale which will be performed at~     baseline, 2 and 6 weeks. A blood draw and urine collection will be done at both baseline and~     6 weeks.~      The central purpose of this proposal is to perform a comparative-effectiveness study of a~     complementary and alternative approach (Johrei therapy) and CBT-I in the treatment of sleep~     disturbances in survivors of critical illness. The investigators hypothesize that, in~     survivors of critical illness, Johrei therapy is superior or comparable to CBT-I in improving~     sleep quality (Pittsburgh Sleep Quality Index [PSQI] and sleep efficiency [measured by~     polysomnography]).~      A secondary objective is to compare the effect of Johrei therapy and CBT-I on systemic~     markers of inflammation and urinary biomarkers of sleep and stress. The investigators~     hypothesize that, in survivors of critical illness, Johrei therapy is superior or comparable~     to CBT-I in reducing systemic markers of inflammation and urinary biomarkers of sleep and~     stress.~      A tertiary objective is to determine whether the presence of insomnia or other sleep~     characteristics is associated with hospital readmissions within 30-days.~   "
115213|NCT02059408|"~     The overall hypothesis of this trial is that screening for chronic kidney disease, followed~     by education or treatment program will improve blood pressure control among hypertensive~     non-diabetic persons.~   "
115214|NCT02059395|"~     Background:~      In cardiac arrest survival rates dramatically increase when bystanders are present and~     initiate Basic Life Support (BLS). However, even though serious efforts have been made, skill~     retention after a traditional time-based BLS course for laypeople remains suboptimal. In~     contrast, a mastery learning-based educational approach was shown to be efficacious and might~     be promising even for laypersons. Therefore the investigators aim to evaluate the impact of a~     mastery learning-based BLS course on skills retention of BLS in laypeople.~      Methods:~      Forty laypeople without previous BLS experiences will be randomized into the traditional~     time-based BLS course group (Control - TB group) or mastery learning-based group~     (Intervention - ML group).~      Both groups will receive BLS training consisting of 6 successive stations including diagnosis~     of cardiac arrest, chest compression, ventilation, one-rescuer BLS, two-rescuer BLS and AED~     use. In the ML group, subjects will deliberately practice and receive feedback at each~     station until a pre-set target level is reached. Subjects will be allowed to proceed to the~     next station only when they achieve the required target level of performance. In contrast,~     participants of the TB group will be taught the same 6 stations in two hours, according to~     standard American Heart Association BLS criteria. All subjects will have an assessment of~     knowledge and skills immediately after teaching (immediate post-test) and at four months~     (retention post-test).~      Implications:~      Previous research has shown that mastery learning-based education improves learners'~     procedural skill performance. The investigators study will determine the impact of a mastery~     learning-based BLS course on skill retention in laypeople.~   "
115334|NCT02057835|"~     BI 691751 is currently being developed to inhibit growth and prevent rupture of~     atherosclerotic plaques and to consequently reduce the risk of major cardiovascular events in~     patients with established atherosclerotic disease. 1334.5 is a Pan Asian Phase 1 study to~     investigate safety, tolerability and pharmacokinetics of BI 691751 in healthy Chinese and~     Japanese male volunteers.~   "
115215|NCT02059382|"~     The purpose of this study is to inform the integration of mobile and social media components~     into larger interventions aimed at increasing adherence and maintenance of physical activity.~     Nearly half of the US population do not meet physical activity recommendations of ≥150~     minutes of moderate activity per week. The use of smartphones to self track data and upload~     that data to an online social network is becoming increasingly common and may be an effective~     way to motivate physical activity adherence and maintenance. We are proposing a two phase~     study to develop and evaluate a mobile health (mHealth) intervention that includes the use~     of two existing technologies: 1) the RunKeeper mobile app to collect and upload exercise data~     (distance, pace, time), and 2) the RunKeeper.com online social network as a place to analyze~     uploaded data and engage with a coach and online community. Phase 1 (n=10) will iteratively~     develop the mHealth intervention and phase 2 (n=30) will pilot the mHealth intervention~     (participants will be randomized to either mHealth intervention (n=20) or control (n=10)) to~     collect feasibility, acceptability and preliminary efficacy data. All participants will~     attend a day-long ChiWalk/Run training to help them avoid potential injuries and meet their~     coach and community in-person. All participants will also be asked to wear a FitBit~     accelerometer from one week before the beginning of the intervention through one week after~     the end of the intervention to collect total physical activity data. This data will be~     uploaded automatically to the study data base. Primary outcomes will be total physical~     activity as collected by the FitBit accelerometer (and the RunKeeper mobile app for the~     intervention group) and secondary outcomes will be changes in psychological factors that may~     mediate adherence to physical activity.~   "
115216|NCT02059369|"~     While there is a consensus to perform pulmonary vein isolation (PVI) as a cornerstone for~     paroxysmal and persistent atrial fibrillation (AF), different additional ablation approaches~     are used for substrate modification: linear lesions, ablation of complex fractionated atrial~     electrograms (CFAE) or a combination of both. The aim of this study is to determine whether~     there is a difference in terms of freedom from arrhythmia recurrence between PVI with CFAE~     ablation in combination or not with linear lesions in patients with persistent AF.~   "
115217|NCT02059356|"~     The purpose and objective of this study is to determine the prevalence of elevated ammonia~     levels in subjects with cognitive impairment, and to observe if treating the cause of the~     elevated ammonia level improves mental status. This study does not include any imaging,~     treatment,or interventions, other than the blood draws. The blood draws will be taken to~     assess blood ammonia level and liver function. If the the ammonia level is not elevated, no~     further lab draws will occur. If the ammonia level is elevated, liver function is normal, and~     a cause for the high ammonia level is revealed with a plan for clinical treatment by the~     subjects' physician, then two more blood draws will occur; one prior to treatment, and one 3~     months after treatment. The main risk to subjects is related to the blood draw (i.e.~     momentary discomfort, bruising, infection, bleeding, clotting or fainting), and there is a~     potential loss of confidentiality. A paired student t test will be done with the two later~     blood to compare objective data.~   "
115218|NCT02059343|"~     Dexmedetomidine is increasingly used for sedation in children placed on cardiopulmonary~     bypass for heart surgery. It is also often used after surgery and may be particularly helpful~     for children with heart disease. In order for this medication to be helpful and to minimize~     risks associated with taking the medication, it is important to provide correct dosing for~     this medication. Based on evidence from studies of other medications used during heart~     surgery, it is likely that dosing of dexmedetomidine while on cardiopulmonary bypass is~     different from dosing in other settings. The purpose of this study is to evaluate how the~     heart-lung bypass machine affects dexmedetomidine levels in the body.~   "
115219|NCT02059330|"~     This study will investigate the dose-proportionality of palbociclib pharmacokinetics in~     healthy subjects of Japanese descent. Approximately fourteen healthy Japanese subjects will~     receive four single doses of palbociclib (PD-0332991) with a minimum washout of 10 days~     between doses. Additionally, this study will investigate the effect of Japanese ethnicity of~     palbociclib pharmacokinetics by comparing palbociclib pharmacokinetics at a single dose-level~     between healthy subjects of Japanese descent and approximately fourteen healthy non-Asian~     subjects.~   "
115220|NCT02059317|"~     The main objective of this study is to compare on day 0 the maximum Lyapunov exponent (lmax,~     an indicator of local dynamic stability) of chronic low back pain patients versus that of~     healthy volunteers matched for age (± 5 years), sex and body mass index (BMI ± 15% of low~     back pain patients).~   "
115221|NCT02059304|"~     The aim of this study is to examine the potential value of cervical length (CL) measurement~     with embryo transfer catheter in the prediction of spontaneous preterm deliveries in~     intracytoplasmic sperm injection (ICSI) cycles.~      Preterm birth is the leading cause of perinatal death and handicap in children. It is clear~     that ICSI pregnancies are at high risk groupfor preterm delivery (PTD). In singletons there~     is an estimated two-fold increased risk following ICSI.~      CL measurement with ultrasound in mid-trimester (22-24 weeks) is the best method for the~     prediction of PTD: The shorter the CL, the higher risk of PTD. Recent evidence suggests that~     at first trimester (11-13 weeks), the risk for PTD is inversely related to CL. It has been~     shown that the measurement of CL on pregnancy is an effective method for identification of~     the group at high risk for PTD.~      In embryo transfer, catheter is placed the through cervical canal. The method we will use in~     this study, CL measurement with transfer catheter, will give more precise results than~     measurement with ultrasound.~      No study has been performed to evaluate the prediction of PTD by analyzing measurements of~     CL, preconceptionally. Our study will be the first in this topic.~      There is a certain disadvantage of measuring CL during pregnancy: The effectiveness of~     prophylactic administrations (progesterone, cervical cerclage etc.) may be inversely related~     to the gestation at which treatment is initiated. If we know the risk of PTD before~     gestation, single embryo transfer will be preferred to avoid from multiple pregnancies that~     also increase the relative risk of PTD, in ICSI pregnancies.~   "
115222|NCT02059291|"~     This study is to determine whether canakinumab is able to induce and maintain a clinically~     meaningful reduction of disease activity in participants with Hereditary Periodic Fevers~     (HPF) compared to placebo.~   "
115223|NCT02059278|"~     This is a Phase 3 study to evaluate the safety and efficacy of T-2345 dosed to one of both~     eyes once daily for 84 days compared to Xalatan dosed to one of both eyes once daily for 84~     days in patients with elevated eye pressure.~   "
115224|NCT02059265|"~     This phase II trial studies how well dasatinib works in treating patients with ovarian,~     fallopian tube, endometrial, or peritoneal cancer that has come back or is persistent.~     Dasatinib may shrink patients' tumors by blocking some of the enzymes needed for cell growth.~   "
116605|NCT02041221|"~     Sun Pharma Advanced Research company Limited has developed a dry powder inhaler of compound~     SPARC1316 for oral inhalation. This clinical study is a Phase I/IIa study to investigate the~     safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending~     doses of S0597 administered by oral inhalation to healthy volunteers and asthma patients.~   "
115225|NCT02059252|"~     SmartMatrix™ is a single layer dermal replacement scaffold for full thickness skin~     replacement. The scaffold consists of a porous matrix of cross-linked human fibrin plus~     alginate that has been designed and optimised to facilitate wound closure and healing through~     cellular ingress and rapid growth of new blood vessels.~      This proof of concept study will involve patients with surgical wounds resulting from the~     excision of basal cell carcinoma (BCC) and squamous cell carcinoma SCC).~   "
115226|NCT02059239|"~     This clinical trial is for men and women with whose lymphoma (non-Hodgkin or Hodgkin) did not~     respond to treatment or has returned after responding to previous therapy, and who are in~     need of a stem cell transplant.~      The purpose of this study is to test the safety and effectiveness of giving the drug~     Bendamustine, followed by high dose chemotherapy, within two weeks prior to a stem cell~     transplant for lymphoma that has not achieved a complete response to salvage (treatment used~     for relapsed disease) chemotherapy.~   "
115227|NCT02059226|"~     Anxiety is a common mental health problem for Canadian youth. Anxiety that is diagnosed as a~     disorder and serious enough to require treatment affects up to 10% of all youth by the age of~     16. Anxiety disorders can have serious negative effects on a young person's personal~     relationships, school performance, and family life. These disorders may not be discovered by~     youth, parents and health care providers. Even if anxiety disorders are discovered, youth may~     not get the right therapy. Anxious youth can become sick if their anxiety is not treated~     properly.~      The investigative team will carry out research to test Breathe, their new Internet-based~     treatment for youth with anxiety problems. Youth can use this treatment at home. Breathe~     includes information materials and personalized homework assignments to help anxious youth~     learn ways to manage anxiety.~      This study is a pilot randomized controlled trial (RCT) with two groups, an~     Internet-delivered cognitive behavioural therapy (CBT) experimental group (Breathe) and a~     resource webpage (control group; considered treatment as usual for youth waiting for~     services). The investigators will evaluate several methodological processes and outcomes~     through the following objectives:~        1. To evaluate the change in youths' anxiety (primary outcome) from pre- to post-~          intervention.~        2. To estimate recruitment and retention rates for a full-scale RCT.~        3. To estimate a sample size for a full-scale RCT.~        4. To define the minimal clinically important difference (MCID) for the primary outcome~          measure.~        5. To measure intervention acceptability.~        6. To determine the use of co-interventions during the trial.~        7. To conduct a preliminary economic analysis.~   "
115228|NCT02059213|"~     This study will look at the effect of adding the drug Palbociclib to CAD (Combined Androgen~     Deprivation) therapy in patients with RB (Retinoblastoma Protein) positive hormone sensitive~     prostate cancer.~      The investigators hypothesize that the addition of Palbociclib to initial ADT (Androgen~     Deprivation Therapy) in patients with newly metastatic RB-positive prostate cancer may~     significantly increase the efficacy of ADT.~   "
115229|NCT02059200|"~     Since a few years, Mindfulness Based Cognitive Therapy (MBCT) has been used as treatment for~     patients suffering from recurrent depression. Though a number of studies show that MBCT is~     effective in this population and MBCT reduces the chances of relapse/recurrence in recurrent~     depressive patients, the chance of a new depression developing after end of treatment is~     still considerable. Ergo, there is room for improvement.~      Especially the development of a non-judging or compassionate attitude towards all experience~     seems to mediate the treatment effect. It is therefore our expectation that a follow-up~     intervention that focuses specifically on self-compassion could prove very useful in~     elaborating on the effects of MBCT.~      The research question of this research is therefore: what is the effect of compassion~     training in people suffering from recurrent depression who have already received MBCT~     training?~   "
115230|NCT02059187|"~     This 24-week study is a safety and efficacy comparison of MK-1293 and Lantus™ in participants~     with type 2 diabetes mellitus (T2DM). The primary hypothesis is that after 24 weeks, the mean~     change in hemoglobin A1c (A1C) from baseline is non-inferior (with margin of 0.4%) in~     participants treated with MK-1293 compared with that in participants treated with Lantus™.~   "
115231|NCT02059174|"~     The purpose of this study is to assess the safety, pharmacokinetics, and pharmacodynamics of~     MK-1293 compared with a basal insulin (EU-Lantus™) in participants with Type 1 Diabetes. The~     primary hypotheses are that the duration of action, pharmacodynamic profile, and~     pharmacokinetic profile of MK-1293 and the comparator basal insulin are similar.~   "
115232|NCT02059161|"~     The purpose of this study is to compare the safety and efficacy of MK-1293 to Lantus™ in~     participants with T1DM. The primary hypothesis is that after 24 weeks, the mean change in~     hemoglobin A1c (A1C) from baseline is non-inferior in participants treated with MK-1293~     compared with participants treated with Lantus™.~   "
115233|NCT02059148|"~     Participants in this study will receive 3 single oral doses of LY2835219 at least 14 days~     apart. One dose will be given with a standard meal, one dose with a high-fat meal and one~     dose without food. The study will evaluate the effects of the standard and high-fat meals on~     how much drug gets into the bloodstream. Side effects will be documented. This study is~     approximately 43 days, not including screening. Screening is required within 28 days prior to~     the start of the study.~   "
115234|NCT02059135|"~     The purpose of the study is to assess the efficacy, safety and pharmacokinetics (PK) of~     recombinant human antithrombin (ATryn) in addition to expectant management for the treatment~     of preterm preeclampsia (PPE). Efficacy will be assessed by comparing the difference in~     extension of gestational age from the time of randomization into the study until delivery~     between ATryn and placebo treated subjects. In addition, the effect of ATryn on fetal and~     neonatal clinical outcomes will be assessed. The PK characteristics of ATryn in the subjects~     will be investigated by measuring AT activity levels in the mother during treatment and in~     cord blood.~   "
115254|NCT02058875|"~     The overall goal of this study is to improve cardiovascular outcomes in transplant~     recipients. The current standard immunosuppressive regimen in kidney transplant recipients~     depends on a higher exposure to the Calcineurin Inhibitor (CNI), and often a less than~     optimal dosage the of mycophenolic acid (MPA) derivative. The premise of this study is to~     investigate the effects of reversing this paradigm. More specifically, the effect of using~     maximum MPA dosages (in the form of enteric-coated mycophenolate sodium [EC-MPS] or~     Myfortic®) along with judicious CNI exposure (cyclosporine/Neoral®) will be investigated.~   "
115235|NCT02059122|"~     This study is a multi-site trial assessing the sensitivity of DENV Detect™ NS1 ELISA versus~     standard reference tests (e.g. PCR or viral culture) for dengue diagnosis in the US and~     internationally.~      The DENV Detect™ NS1 ELISA serves as an aid in the clinical laboratory diagnosis of early~     stages of Dengue infection in patients with clinical symptoms consistent with Dengue~     infection. This test is intended to be used on sera obtained within the first 7 days of~     symptoms. DENV Detect™ NS1 ELISA results (positive or negative) must be confirmed by testing~     with a reference standard test.~      Subjects will be patients who present with symptoms consistent with dengue infection, such as~     fever and myalgia. After informed consent is obtained and the subject is screened for~     eligibility, 2 diagnostic samples will be collected. The first will be collected within the~     first 7 days of symptoms onset, and the second will be collected at least 7 days later,~     between the 10th and 21st days post-onset of symptoms.~      ELISA and reference tests will be performed by different operators who are laboratory staff~     members. These staff members, blinded to each other's results, will evaluate the samples from~     each method independently.~   "
115236|NCT02059109|"~     The Belmont Rapid Infuser is a device currently approved to replace larger volumes of~     necessary fluids such as blood in a fast and safe manner. The purpose of the study is to~     evaluate proficiency and the retention of knowledge of how to use the device based on current~     methods of training compared to revised training methods.~      Hypotheses:~        1. The use of the traditional method of training is not effective, predicting less then~          half of staff will pass on the first attempt.~        2. Restructured test with hands-on training as opposed to oral presentation only with a~          written test will result in a pass rate of > 80%.~        3. Staff members who work in pairs will perform better than working alone when setting up~          the Belmont Rapid Infuser (BRI).~        4. Retention at 3 months will be higher with the restructured training method than with the~          traditional training method.~   "
115237|NCT02059096|"~     This study is designed to evaluate the effect of repetitive Transcranial Magnetic Stimulation~     (rTMS) in the resolution of chronic pain. Participants will be patients with Multiple~     Sclerosis suffering from chronic pain of neurological origin.~   "
115238|NCT02059083|"~     The aims of this study are: 1) to estimate the effect size of HRV biofeedback for stress in~     adolescents undergoing cognitive behavioral therapy (CBT) for cannabis use disorder (primary~     outcome: Perceived Stress Scale) and 2) to estimate the effect size of HRV biofeedback for~     cannabis use in adolescents undergoing CBT for cannabis use disorder (primary outcome: number~     of days used cannabis in the past 30 days).~   "
115239|NCT02059070|"~     Background: Outpatient continuous interscalene brachial plexus blocks are used to control~     pain after shoulder surgery, with infusions of 0.125% bupivacaine or 0.2% ropivacaine. There~     have been no studies comparing the effects of these two formulations. The major concern is~     hemidiaphragmatic paresis, and since ropivacaine preferentially blocks sensory fibers, it may~     cause less blockade of the phrenic nerve. This study was to evaluate the effects of~     continuous interscalene brachial plexus infusions, with the hypothesis that respiratory~     function is more affected by 0.125% bupivacaine than 0.2% ropivacaine, with equal effects on~     pain relief.~      Methods: All patients underwent baseline spirometry and ultrasound evaluation of~     diaphragmatic excursion, followed by interscalene catheter placement for their surgery, then~     randomized to receive a pump containing 0.2% ropivacaine or 0.125% bupivacaine. Patients~     returned to the hospital the following day for spirometry, ultrasound reevaluation, and~     evaluation of their pain level since discharge.~   "
115240|NCT02059057|"~     Crossover study for patients who were randomized to the Control Group in CLN0009.~   "
115241|NCT02059044|"~     One of the most common health care interventions in any healthcare setting is a medication~     prescription. Unfortunately, up to 25% of outpatient prescriptions are associated with~     adverse drug events (ADEs). ADEs decrease patient health directly and can lead to~     non-adherence, which in turn has negative consequences.~      The investigators recently conducted a pilot project in which the feasibility and potential~     utility of an information technology enabled outreach program for monitoring patients~     receiving an outpatient prescription was tested. This intervention involved the use of an~     interactive voice response system programmed to automatically call ambulatory care patients~     following a prescription. If the system identified a potential medication problem, a~     pharmacist was notified who contacted the patient, modified the therapy accordingly, and~     informed a physician when necessary.~      The pilot project included 568 patients with diverse illnesses in two Canadian cities. High~     levels of patient and provider acceptability of the system were determined from 21 day~     interviews. The program identified 56 of 125 (45%) ADEs and 10 of 26 (30%) of primary~     non-compliance events. Very few episodes of ameliorable ADEs were observed.~      The investigators feel these results justify a randomized control trial to assess the~     effectiveness of the intervention for improving patient centered outcomes. Ambulatory care~     patients receiving incident prescriptions for one of four conditions (hypertension, diabetes~     mellitus, depression, and anxiety) will be randomized to the intervention or routine care.~     The investigators expect that the system will reduce the severity and duration of outpatient~     ADEs and improve adherence to medication care.~   "
115242|NCT02059031|"~     This study will evaluate two new GSK1265744 sodium salt tablet formulations and provide data~     for selection of one of these tablet formulations for use in Phase 3. This is a~     single-center, randomized, two part, open-label, crossover study in healthy adult subjects.~     Part A is a randomized, open-label, 3-way balanced cross-over design in 24 subjects to assess~     the oral bioavailability of two GSK1265744 sodium salt tablet formulations relative to the~     current GSK1265744 sodium salt formulation being used in the phase IIb studies under fasting~     conditions. Part A treatment periods will be separated by a 14 day washout. After completion~     of Part A, preliminary PK data will be analyzed and a decision will be made based on~     pre-specified criteria, as to which formulation will be used to conduct Part B. Fifteen~     subjects who will have participated in Part A will participate in Part B and receive the~     selected formulation with a moderate fat meal. All treatments will be administered as single~     30 mg doses of GSK1265744. Safety evaluations and serial PK samples will be collected during~     each treatment period. A follow-up visit will occur 10 - 14 days after the last dose of study~     drug.~   "
115243|NCT02059018|"~     The primary objective is to study if a stimulation of nitric oxide and/or prostaglandin~     affect the diameter changes of retinal vessels during hypoxia. Diameter changes are studied~     using the Dynamic Vessel Analyzer.~   "
115244|NCT02059005|"~     This study will assess Specialized Community Disease Management (SCDM), an intervention which~     employs various evidence-based strategies to engage substance using co-morbid patients while~     in the hospital and follow them into the community via an empirically validated telephone~     approach as well as contact with a trained community health worker peer specialist. The~     investigators will first adapt and refine the core SCDM intervention with patient, provider,~     and stakeholder input through an active community advisory board. The investigators will then~     conduct a three-year, randomized controlled trial of 222 patients enrolled prior to hospital~     discharge who are diagnosed with congestive heart failure, pneumonia, acute myocardial~     infarction, chronic obstructive pulmonary disease, diabetes mellitus, or end-stage renal~     disease, and a substance use disorder (SUD). Patients will be randomized to either the SCDM~     intervention or Treatment as Usual (TAU), in which a team of nurse navigators and community~     health workers follow patients (primarily by telephone) for 90 days post-discharge, but do~     not address the specific needs of SUDs. The investigators will test the following four~     hypotheses: (1) patients randomized to SCDM will demonstrate larger reductions in substance~     use measured by urine-confirmed self-reported days using over the 6-month follow-up compared~     to patients randomized to TAU, (2) patients randomized to SCDM will attend more specialty~     substance abuse intervention and treatment sessions over the 6 month follow-up than patients~     randomized to TAU, (3) patients randomized to SCDM will demonstrate reduced HIV transmission~     risk behaviors and greater rates of HIV testing over the 6 month follow-up than patients~     randomized to TAU, and (4) patients randomized to SCDM will experience fewer days of~     rehospitalization and use of acute emergency services than patients randomized to TAU.~   "
115245|NCT02058992|"~     The purpose of this study is to investigate the safety and efficacy of ramelteon (Rozerem)~     when used in the routine clinical setting in patients with sleep-onset difficulty associated~     with insomnia.~   "
115246|NCT02058979|"~     Abstract The administration of an antibiotic preoperatively is an important intervention that~     helps to reduce the risk of post-operative health-care associated infections (HCAI). These~     include urinary tract, surgical site and blood stream infection. Based on the current~     Surgical Infection Prevention Project, (SCIP) recommendations, the choice of the antibiotic~     is based on the nature and site of the surgery and the presence of a β-lactam allergy (Table~     1).~      Currently, the antibiotic treatment for preventing surgical infections is administered as a~     single bolus an hour before surgery, and every four hours after the initial dose. This~     presents a concentration profile that has a high concentration after the bolus, but decays as~     the kidneys remove the antibiotics. In this present study, investigators would like to~     compare this traditional method of delivery to a constant infusion model that would sustain a~     constant level of antibiotics that is defined by the difference between the rate of infusion~     and rate of clearance.~   "
115247|NCT02058966|"~     Addiction to methamphetamine is a serious health problem. There are no medications that a~     doctor can give someone to help them stop using methamphetamine. Entacapone (Comtan©) is a~     medication that could help people addicted to methamphetamine.~      This study will see how entacapone works in healthy people who are given methamphetamine. We~     think that the study drug will be well tolerated, and that it will prevent some of the~     effects of methamphetamine that make it so addictive. We also want to see how differences in~     people's genes may cause differences in the ways the study drug and methamphetamine work for~     them.~      The study has six total visits. The first visit is for screening. Tests and procedures will~     make sure it is safe for subjects to participate.~      The second visit is a familiarization day. Subjects will receive methamphetamine, but no~     entacapone. This is done to make sure they can tolerate the drug and recognize its effects~     before being given a second drug on the same day. Subjects will take surveys and computer~     tests to see how the medications change mood, thinking, and liking the drug.~      The final four visits are the actual study days. Subjects will be randomly assigned (like the~     flip of a coin) to the different ways to get either 1) study medication or placebo (placebo~     contains no active study medication) and then 2) methamphetamine or placebo. Subjects will be~     in all four groups during the study, which means that each day a subject will get a different~     group.~   "
115248|NCT02058953|"~     The purpose of this study is to collect and bank samples of blood and tissues (such as brain~     tissue or lymph nodes), as well as cerebrospinal fluid (CSF), which is the fluid that bathes~     and cushions the spinal cord. The investigator will analyze DNA biomarkers in the samples.~     The investigator hopes that by studying the biomarkers, he can develop tests in the future~     that can detect central nervous system (CNS) metastasis in blood samples before they show up~     on x-ray and develop medicines that can specifically target CNS metastasis.~   "
115249|NCT02058940|"~     The purpose of this study is to assess the feasibility of exenatide infusion for the~     treatment of high blood sugars following acute brain injury.~   "
115250|NCT02058927|"~     This is an observational study of HIV-1 infected children starting antiretroviral therapy to~     measure the magnitude and quality of general immune reconstitution and pathogen-specific~     immune reconstitution to measles virus.~   "
115251|NCT02058914|"~     We examined the effects of short-term (2-wk) consumption of HF- and HG-sweetened beverages in~     adolescents (15-20 yr of age) on insulin sensitivity, insulin secretion, insulin clearance,~     triacylglycerol (TAG), and cholesterol concentrations.~   "
115252|NCT02058901|"~     The primary objective of this study is:~        -  To determine the maximum tolerated dose (MTD) of sunitinib when administered once weekly~          or once every two weeks.~        -  To assess the safety and tolerability of sunitinib in a once weekly or once every two~          weeks dose schedule.~   "
115253|NCT02058888|"~     The worldwide increase in the incidence of multidrug-resistant (MDR) pathogens is alarming.~     Antimicrobial treatment is a risk factor for the isolation of MDR pathogens and can therefore~     contribute to the observed trend. Differences in the degree of selection pressure caused by~     various antimicrobials have not been systematically investigated until today. The aim of the~     proposed project is the determination of the impact of antibiotic treatment on the copy~     number of resistance genes in the human intestinal microbiome using metagenome shotgun~     sequencing. The resistance gene count in the gastrointestinal tract will be determined in a~     clinical cohorts of patients treated with either ciprofloxacin or cotrimoxazol as~     monotherapy. The subsequent quantification and comparison of the selection pressure~     facilitates the application of antibiotics with a lower potential to select for resistance.~     To achieve this goal, a self-controlled, prospective observational epidemiological study will~     be performed at two centres of the German Centre for Infection Research (Tübingen, Cologne).~   "
115255|NCT02058862|"~     The purpose of this study is to determine if a home-based electrical stimulation (ES) program~     is more effective than the standard of care (SOC) at improving quadriceps function,~     functional outcomes, patient reported outcomes, and treatment compliance in patients~     recovering from knee surgery. It is hypothesized that there will be significantly better~     outcomes and compliance in ES group when compared to the SOC group.~   "
115256|NCT02058849|"~     The objective of the current proposal is to determine if concentrated beet root could improve~     medical treatment compliance as defined by completion of radiotherapy and 3 cycles of~     chemoradiation without dose reduction, preserve fat-free mass, and strength while reducing~     mucositis. The investigators central hypothesis is that dietary nitrate supplementation in~     head and neck cancer patients receiving aggressive medical care will improve compliance with~     medical treatment by attenuating the loss of muscle mass and strength and reducing symptoms~     (mucositis) associated with treatment compared to patients receiving standard care with~     placebo.~   "
115257|NCT02058836|"~     The purpose of this research study is to determine if Botox injections will provide relief~     from chronic testicular pain. In the study, the spermatic cord of particpants will be~     injected with either Botox or a placebo of saline. Botox is currently used to treat other~     urological conditions like overactive bladder and lower urinary tract problems. For these~     conditions, Botox works by relaxing muscles in the affected areas. The investigators believe~     that Botox will act similarly in the treatment chronic testicular pain.~   "
115258|NCT02058823|"~     The purpose of this study is to compare cardiovascular physiological adaptation to~     intermittent hypoxia (IH) of nonobese healthy subjects. The exposure will be two periods of~     two weeks (IH versus exposure placebo hypoxia). The investigators will use pharmacological~     tools, peripheral vasodilator (amlodipine) or specific blocker of angiotensin receptor~     (valsartan) versus the taking of a placebo. The allocation of the tool and the exhibition~     will be randomized (HI / placebo, valsartan / amlodipine). The outcome measures evaluated~     concern the cardiovascular system, systemic inflammation and tissular and glucose metabolism.~      The investigators assume an increase in arterial resistance during the intermittent hypoxia~     compared to the control group, these being dependent on sympathetic tone.~      The investigators hypothesize that the metabolic alterations that will be observed after~     experimental simulation (IH and fragmentation of sleep for 15 consecutive nights) will be~     less severe in the valsartan group than in the amlodipine group in comparison with the~     placebo group.~      A serum bank and a gene bank will be performed for the requirements of subsequent studies if~     necessary.~   "
115259|NCT02058810|"~     The pilot study aims to compare the results of using a new respirator (OPTIFLOW~     TM-High-Flow-Machine) with those from Standard-Oxygen-Therapy during the stabilization of~     patients who have been hospitalized due to acute heart failure. We expect a faster and more~     effective stabilization after acute cardial decompensation among the patients with the~     High-Flow-machine.~      The study should show whether the use of High-Flow-Therapy leads to a relevant improvement in~     terms of objective clinical parameters of heart failure like those for cardial-renal~     syndrome, changes in the nt-pro-BNP, weight loss, changes in the diameter of the inferior~     vena cava, in terms of the degree of shortness of breath and decompensation, and whether~     subjective clinical symptoms like dyspnea and quality of life differ between the two groups~     of patients.~      The investigators see the primary outcome of the study as the improvement of the~     cardial-renal syndrome as a sign of the more effective stabilisation compared to the standard~     therapy. Furthermore, the investigators expect a quicker decrease in serum creatinine and an~     improvement in the creatinine clearance through therapy with the High-Flow-Machine. In terms~     of secondary outcomes of the study, the investigators are interested in also comparing e.g.,~     the duration of hospital stays, 90-day mortality, and rehospitalisation within three months.~     Here, the investigators expect a quicker improvement in the subjective shortness of breath of~     the patients who are treated using the Hifh-Flow-Machine. Moreover, we believe that along~     with the individual subjective improvements (quality of life survey), the patients will~     experience a quicker release from the hospital and in this way, lead to a healthcare economic~     improvement among patients with repeated hospitalizations who usually have chronic problems.~      It is also of great interest to us, whether the biomarker BNP is an appropriate parameter for~     determining the faster stabilization of the patient and whether the degree of improvement of~     subjective dyspnea is correlated with the time needed until the patient has been stabilised.~   "
115260|NCT02058797|"~     The purpose of this study is to determine the efficacy of Coherence Therapy in treating~     procrastination. For that, this intervention is compared to Cognitive-Behavioral Therapy~     which was already proved to be efficacious in treating this problem. The method used is a~     randomized controlled trial.~   "
115261|NCT02058784|"~     Open label study of Pracinostat will be tested to assess the effect of food on the~     single-dose pharmacokinetics in healthy non-smoking and smoking adult subjects under fasted~     and fed conditions.~   "
115262|NCT02058771|"~     It is universally recognised that current methods for risk stratification of sudden cardiac~     death (SCD) are limited. A novel SCD risk marker, the Regional Restitution Instability Index~     (R2I2), measures the degree of heterogeneity in electrical restitution using data obtained~     from a standard 12 lead ECG acquired during an invasive electrophysiological study.~      In an ischaemic cardiomyopathy (ICM) cohort of 66 patients, an R2I2 of ≥1.03 identified~     subjects with a significantly higher risk of ventricular arrhythmia (VA) or death (43%)~     compared with those with an R2I2 <1.03 (11%) (P=0.004).~      This study will use non-invasive techniques to acquire electrical restitution data: exercise~     and pharmacological stress, and will incorporate body surface potential mapping to develop a~     non-invasive and high-resolution form of R2I2. Suitable patients will be recruited into a~     prospective, observational study.~      HYPOTHESES:~      PRIMARY:~        1. R2I2 is predictive of ventricular arrhythmia (VA) / SCD in patients with ICM.~        2. The exercise stress protocol will create a dynamic range of heart rates that allows ECG~          quantification of electrical restitution heterogeneity that correlates with invasive~          R2I2 and is predictive of VA/SCD. The pharmacological stress protocol will create a~          dynamic range of heart rates that allows ECG based quantification of electrical~          restitution heterogeneity that correlates with invasive R2I2 and is predictive of~          VA/SCD.~      SECONDARY:~        1. A high-resolution electrical map acquired using body surface potential mapping will~          correlate with R2I2 and these data can be included in the R2I2 calculation to improve~          its prediction of SCD/VA.~        2. Serial measurement of R2I2 will produce consistent values.~   "
115263|NCT02058758|"~     Contrast-enhanced magnetic resonance imaging (CE-MRI) is now established as the most accurate~     non-invasive imaging modality for characterizing breast cancer. CE-MRI has a very high~     sensitivity because the intravenous MR contrast agent highlights regions with increased~     vascularization and vascular permeability compared to normal breast tissues and benign~     lesions.~   "
115264|NCT02058745|"~     This is a study to evaluate the effectiveness of using an established intervention for~     depressive symptom management in conjunction with a needs-based caregiver intervention for~     improving the psychological and physical health of family caregivers of persons recently~     diagnosed with a Primary Malignant Brain Tumor.~   "
115265|NCT02058732|"~     Study the cervical spinal cord and brain over time to assess changes and differences in~     subjects with amyotrophic lateral sclerosis.~   "
116606|NCT02041208|"~     The purpose of this study es to determine hemoglobin variability in kidney transplant~     recipients with chronic renal anemia.~   "
115266|NCT02058719|"~     This study plans to learn more about pulmonary complications of human immunodeficiency~     virus/acquired immunodeficiency syndrome (HIV/AIDS). Even though antiretroviral therapy (ART)~     has dramatically decreased the number of opportunistic infections and deaths in HIV infected~     patients, pulmonary complications (including chronic obstructive pulmonary disease (COPD)~     development and pneumonias resulting in decreased lung function) of HIV/AIDS continue to be a~     major cause of morbidity and mortality in this population. The mechanisms underlying the~     increased risk of COPD and decreased lung function in HIV infected individuals is not well~     understand and needs to be studied.~      The investigators hypothesize that the immunoregulatory consequences and immunosuppressive~     lung milieu secondary to HIV and cigarette smoke combine to increase the risk of lung~     infection and injury in HIV infected smokers, hastening the development of COPD. The~     mechanisms will be directly tested using blood and bronchial alveolar lavage (BAL) cells from~     smokers and nonsmokers with and without HIV infection.~   "
115267|NCT02058706|"~     This randomized phase II trial studies if enzalutamide added to standard luteinizing~     hormone-releasing hormone (LHRH) analogue therapy will improve effects against prostate~     cancer compared to the standard therapy of LHRH analogue and bicalutamide. Hormone therapies~     stop the body from producing or block the effect of male sex hormones (testosterone).~     Enzalutamide blocks the effect of male sex hormones which are responsible for the growth of~     prostate cancer. Hormonal therapies that lower the level of testosterone are among the most~     effective treatments for prostate cancer that have spread to other areas of the body~     (metastasized). It is not yet known whether LHRH analogue therapy with bicalutamide is more~     effective than LHRH analogue therapy with enzalutamide in treating prostate cancer.~   "
115268|NCT02058693|"~     In this Phase 4 trial we will study the safety, tolerability and efficacy of mixed salts~     amphetamine (MSA), trade name Adderall, augmentation of antidepressant therapy for Major~     Depressive Disorder (MDD) in depressed outpatient adults who are taking an antidepressant but~     have not had complete resolution of their symptoms.~      40 adult outpatients with MDD who failed at least one adequate trial of antidepressant~     monotherapy will be consented in a 63-day, cross-sequential, multicenter study comprising two~     treatment phases of 21 days each. The time frame from consent to baseline is 7 days. Patients~     will receive placebo or MSA in Phase 1, and in Phase 2, participants will receive MSA. There~     will also be a two-week follow up visit after the completion of Phase 2.~      We hypothesize that MSA will be safe and well tolerated, and will improve the patient's~     response to their antidepressant and provide superior symptom relief to antidepressant alone.~     The primary outcome measure is the Massachusetts General Hospital Cognitive-Physical Function~     Questionnaire (MGH-CPFQ).~   "
115269|NCT02058680|"~     This study is investigating the safety and efficacy of a vaccine directed against prostate~     tumor cells. The researchers are interested in evaluating the safety and tolerability of the~     vaccine, and the effects of the vaccine on survivability, time to measurable disease,~     prostate-specific antigen (PSA) level in the blood, and the immune response to the vaccine.~      Eligible patients include those with recurrent prostate cancer as shown by elevated levels of~     PSA, although there is no evidence of tumors that are measurable by imaging studies. In~     addition, to be eligible patients must have prostate cancer that either has not been treated~     by hormonal therapy or is not responsive to hormonal therapy.~   "
115270|NCT02058667|"~     The purpose of this trial in addition to a dose finding study for concurrent Paclitaxel, will~     be to establish a treatment algorithm for chest wall reirradiation. A nominal margin of at~     least 5cm will be used on the protocol and extending it to 7cm. Considering the standard~     treatment of breast cancer incorporates a cumulative dose of 60Gy, delivering an additional~     50.4 Gy followed by a boost should target a total dose of 120 Gy.~   "
115271|NCT02058654|"~     This study will examine the impact of creatine supplementation on muscle function and~     cognitive performance in young and older subjects.~   "
115272|NCT02058641|"~     This will be an exploratory, open-label, single sequence, two part study (Part A and an~     optional Part B). The aim of this study will be to assess whether systemic inhibition of~     Lipoprotein associated phospholipase A2 (Lp-PLA2) in humans, effected by 11 days of once~     daily dosing to steady state with 160 milligrams (mg) of enteric coated (EC) darapladib, will~     specifically reduce the number of macrophages and/or result in a higher proportion of M2~     macrophages in skin blisters induced by cantharidin (a chemical agent that causes blisters).~     In Part A of the study, a cohort of 8 subjects with type 2 diabetes mellitus will be~     recruited. In Part B of the study, a cohort of 8 additional healthy subjects with matching~     age (+/- 24 months) and gender to Part A may be recruited.~   "
115273|NCT02058628|"~     This is a randomized, comparator-controlled, single-blind, parallel-group study. The current~     study proposes to compare a fixed-dose combination product containing 3% benzoyl peroxide~     (BPO) and 1% clindamycin against a cream containing 20% azelaic acid for the treatment of~     facial acne vulgaris. The results of the study will enable a better assessment of the safety~     and efficacy of the new dose regime (BPO 3% + clindamycin 1%) in comparison to a well~     established treatment. Based on the data more evidence based recommendations will be possible~     to improve the treatment of subjects with acne vulgaris. A total of 220 subjects will be~     enrolled and will have 5 study visits (Day 1, Weeks 2, 4, 8 and 12). The duration of the~     study will be over 12 weeks.~   "
115274|NCT02058615|"~     Male partners of women with breast cancer experience distress, so we want to develop a way to~     support them so they, in turn, can care for their wives. The purpose is to pilot test an~     online male spouse transition toolkit (MaTT) that the research team has developed. The~     specific aims are to: a) evaluate the Toolkit for ease of use, acceptability, and~     feasibility, and; b) collect preliminary data to determine potential effectiveness of the~     Toolkit in increasing hope, general self-efficacy and quality of life, and its potential~     effectiveness in decreasing guilt scores for male partners of women with breast cancer~     (stages 1-3).~   "
115307|NCT02058186|"~     Background: Increase in skin colonization of Staphylococcus aureus (S. aureus) in atopic~     dermatitis patients (AD) resulted from the reduction of cathelicidin production in these~     patients plays the important role in pathogenesis of this disease. Recently in vivo study has~     showed that vitamin D can stimulate cathelicidin production. Oral supplement of vitamin D~     might be beneficial in atopic dermatitis.~      Objective: To determine the effect of oral vitamin D supplement on clinical impact including~     skin colonization of S. aureus in atopic dermatitis patients.~   "
115275|NCT02058602|"~     This is a clinical study to characterise the lung function, airway morphometry, pharyngometry~     and inhalation profiles in patients with mild to severe Idiopathic Pulmonary Fibrosis (IPF)~     over a period of up to 6 months. Inhalation profiles will be recorded from patients with IPF~     as they inhale during tidal breathing, and following two sets of instructions (maximal effort~     and 'long, steady and deep' inhalation), across a range of airflow resistances that reflect~     those of typical inhalers used to deliver medication to the lungs. Mouth and throat~     dimensions will be measured using an acoustic reflectance Pharyngometer. Measurements of lung~     function will be made using conventional sprirometry, plethysmography and diffusion, whilst~     Low Dose High Resolution Computed Tomography (HRCT) will be used to scan the airways at two~     lung volumes; functional residual capacity (FRC) and total lung capacity (TLC). Data from~     HRCT will be used to reconstruct airway morphometry, and model inhaled particle deposition~     within the lung. Overall, the study allows a further understanding of the IPF patient~     population, using the data to assist in the development of new inhaled products for this~     disease. Following up the patients with additional HRCT scans at 3 and 6 months will enable~     the sensitivity of CT based criteria of disease progression to be compared with lung function~     criteria. No investigational product will be used in this study.~   "
115276|NCT02058589|"~     The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals'~     HZ/su vaccine administered on a 0- and 1- to 2-months schedule in adults 18 years of age or~     older who are receiving chronic immunosuppressive therapy.~   "
115277|NCT02058576|"~     The purpose of this study is to assess the bioequivalence of the second generation~     dutasteride and tamsulosin hydrochloride (HCL) combination capsule versus currently available~     commercial combination of dutasteride 0.5 milligrams (mg) and tamsulosin HCL 0.4 mg capsule~     in healthy adult male subjects. Subjects in this study will receive either a single oral dose~     of the second generation dutasteride 0.5 mg and tamsulosin 0.4 mg combination capsule or a~     single dose of commercially available combination of dutasteride 0.5 mg and tamsulosin HCL~     0.4 mg capsule followed by a 28-day washout period both in fed state. The study will enroll~     approximately 92 healthy adult male subjects in order to complete approximately 76 evaluable~     subjects. The total duration of a subject's involvement in this study is anticipated to be~     approximately 12 weeks.~   "
115278|NCT02058563|"~     The purpose of this study is to evaluate the immunogenicity and safety of GSK's trivalent MMR~     (Priorix®), comparing it to Mercks MMR vaccine (M-M-R®II), which is approved for use in the~     US.~   "
115279|NCT02058550|"~     This randomized, pilot phase I trial studies whether phone or email reminders increases~     vaginal dilator use in patients with endometrial, cervical, or vaginal cancers after they~     undergo brachytherapy. Brachytherapy is a type of internal radiation which uses radioactive~     material placed directly into or near a tumor to kill tumor cells. A reminder program may~     help increase use of vaginal dilators and decrease long-term side effects following~     brachytherapy.~   "
115280|NCT02058537|"~     The primary goals of this study are to ease the symptoms of patients with Eosinophilic~     Esophagitis (EoE) and to test the effectiveness of the drug bethanechol in relieving those~     symptoms.~   "
115281|NCT02058524|"~     The investigators are conducting an open-label study of fecal microbiota transplantation~     (FMT) for adult patients with mildly-moderately active ulcerative colitis. In this pilot~     study the investigators will evaluate the feasibility, safety, and tolerability of a single~     application of FMT delivered colonoscopically. The investigators will also characterize the~     impact of FMT on the microbiota of the recipient and determine if it correlates with the~     microbiota from the FMT donor.~   "
115282|NCT02058511|"~     The study comprises of a series of pupillary measurements using infrared pupillometry in~     patients undergoing arthroscopic knee surgery of any type.~      Infrared pupillometry will be used to assess whether a painful stimulus results in pupillary~     reflex dilation (PRD). The extend of the PRD may be an indicator how painful a stimulus is.~     This may help to predict the amount of discomfort a patient will be experiencing after~     emergence from general anesthesia.~      In addition to measuring the pupillary reflex dilation, we will also measure oscillations of~     pupil size before and after indiction of anesthesia, as well as during recovery. These~     spontaneously occuring oscillations in pupil size, also called hippus, appear to be sensitive~     to anesthetics and opioids. However, the effect of these drugs on hippus has not been~     systematically addressed.~      The aim of the study is~        1. to identify whether regional anesthesia techniques such as femoral and sciatic nerve~          blocks will block the PRD. This would allow assessment of block success in the~          anesthetized patient.~        2. to correlate the extent of the pupillary reflex dilation and hippus in the anesthetized~          patient during and at the end of surgery with early postoperative pain scores and~          subsequent analgesia requirements. Such correlation would allow to predict the amount of~          postoperative pain before the patients emerge from general anesthesia.~   "
115283|NCT02058498|"~     Will adult liver transplant patients who are provided with physical activity (walking)~     instructions increase their physical activity and perceive an improved quality of life?~   "
115284|NCT02058485|"~     Hypertensive patients' often severe hypotensive response after induction of anesthesia and~     excessive increase in blood pressure to stresses such as laryngoscopy, intubation, surgical~     incision and extubation. There are many publications in the literature of preoperative~     evaluation of patients with hypertension and perioperative treatment of hypertension but is~     not sufficient about anesthetic management of these patients. Purpose of our study, was to~     investigate the haemodynamic effects of dexmedetomidine and midazolam used for premedication~     in hypertensive patients relative to each other and according to the normotensive patients.~   "
115285|NCT02058472|"~     Study Design : randomized, open label, single-dose, 2-way cross-over design~      Phase : Phase I~   "
115286|NCT02058459|"~     The purpose of this study is to evaluate safety of Targeted Lung Denervation (or TLD) in~     patients suffering from moderate to severe COPD. It is hypothesized that TLD will have a~     similar safety profile and improved physiological and functional outcomes to a sham-control.~   "
115287|NCT02058446|"~     The antihypertensive effect of Amlodipine/Valsartan combination has been evaluated in~     worldwide populations including Asian patients. The study primarily aims to evaluate the~     effectiveness of Amlodipine/Valsartan combination in patients with essential hypertension in~     Taiwan using a prospective, open-label, non-randomized approach.~      The study also wants to investigate the safety of Amlodipine/Valsartan combination during the~     6-week treatment period.~   "
115288|NCT02058433|"~     Platinum-based doublets including paclitaxel, gemcitabine, or docetaxel are standard 1st~     regimens in Non-Small Cell Lung Cancer(NSCLC). The traditional method of individualizing~     cytotoxic drug dose is by using body surface area(BSA), which is not correlated with the~     ability of an individual to metabolize or excrete cytotoxic drugs, because it is not related~     to liver function and is poorly correlated with glomerular filtration rate, and does not seem~     to be a determinant of toxicity. Pharmacokinetic parameters such as area under the curve have~     been shown to correlate with toxicity. The advantages of using a fixed dose of antineoplastic~     agents for all of the patients are obvious. Pharmacokinetically guided treatment would avoid~     severe adverse effects, which has not been sufficiently investigated in advanced NSCLC.First,~     the investigators monitor the blood concentrations of paclitaxel and neutropenia blood~     toxicity after chemotherapy with paclitaxel and carboplatin in patients of NSCLC and verify~     suitable paclitaxel therapeutic window for Chinese patients. Then the investigators compare~     safety and efficacy between individual paclitaxel dose adjustment based on the therapeutic~     window compared with conventional dosage.~   "
115289|NCT02058420|"~     Osteoporosis (severe bone loss) is a bone disease with bone fragility and an increased chance~     for bone fractures. Women are 4 times more likely to have osteoporosis than men because there~     is no estrogen protection after menopause and women in general have lighter and thinner~     bones. Recent studies have indicated tocotrienols (one kind of vitamin E) supplement may be~     good for the bone health in postmenopausal women. However, no study has ever been done the~     role of tocotrienols in bone health in postmenopausal women. Our long-term goal is to develop~     a new strategy featuring a dietary supplement (i.e., tocotrienols) for slowing down bone loss~     in postmenopausal women. The purpose of the study is to examine the effect of 12-week~     tocotrienols on bone measurements in postmenopausal women. Investigators plan to recruit~     postmenopausal women using flyers, non-solicited e-mail system, campus announcement, local~     radio, newspapers, and TV scripts. We plan to enroll approximately 200 women to obtain 78~     qualified women at the start of the study. After screening, qualified participants will be~     matched by body weight and age, and then randomly assigned to no tocotrienols, low~     tocotrienols, or high tocotrienols group. The outcome measures will be assessed at baseline,~     after 6, and after 12 weeks. Bone-related measurements will be recorded using blood and urine~     samples. Investigators will monitor safety of subjects after 6 and after 12 weeks. Food~     intake, physical activity, and quality of life will be assessed at baseline and 12 weeks. All~     data will be analyzed statistically.~   "
115290|NCT02058407|"~     This study is the first administration of GSK2793660 to humans and will evaluate the safety,~     tolerability, PK and PD of single oral ascending doses of GSK2793660, and of repeat oral~     doses of GSK2793660 in healthy subjects. The study will comprise two parts (Part A and Part~     B). Part A will consist of two cohorts of subjects, each taking part in a three-way cross~     over study, with ascending doses of GSK2793660 and placebo. Available safety, PK and PD data~     will be reviewed before each dose escalation. This will be followed by a food-effect arm in~     the cohort that received what is deemed to be the target clinical dose. Part B is planned to~     consist of up to two cohorts of subjects, each taking part in one 14 day repeat dose study~     period. Subjects will be dosed on Day 1 and then on Days 3-15. It is planned that two doses~     will be evaluated. The dose(s) to be tested will be selected based on safety, PK, and PD from~     Part A. The study is intended to provide sufficient confidence in the safety profile of the~     molecule and information on target engagement to allow progression to further studies.~   "
115291|NCT02058394|"~     The purpose of this study is to investigate postoperative events in patients noted to have~     retained nuclear fragments in the anterior vitreous during routine phacoemulsification and in~     those who did not.~   "
115292|NCT02058381|"~     Based on the evidence acquired in the post-menopausal setting with everolimus and on~     pre-clinical evidences supporting the investigation of PI3K inhibitors, such as alpelisib and~     buparlisib, in combination with endocrine therapy in hormone receptor-positive MBC, the~     purpose of this phase Ib trial is to assess the maximum tolerated dose (MTD) and/or the~     RP2D(s), to characterize the safety and tolerability, to determine the single and multiple~     dose PK profile and assess the preliminary anti-tumor activity of alpelisib and buparlisib in~     combination with tamoxifen plus goserelin acetate in premenopausal hormone receptor-positive~     advanced breast cancer patientsgroup.~   "
115293|NCT02058368|"~     This is a multicentre, randomised, double-blind, parallel group study in Asian subjects. The~     aim of the study is to investigate whether combination therapy with dutasteride and~     tamsulosin is more effective than tamsulosin monotherapy for the improvement of symptoms and~     health outcomes in an at risk population of benign prostatic hyperplasia (BPH) clinical~     progression including older men (>=50 years), with moderate-severe symptoms of BPH, enlarged~     prostates (>=30 cubicentimeter [cc]) and prostate specific antigen (PSA) >= 1.5 nanograms per~     milliliter (ng/mL). Each subject who met the eligibility criteria at screening will enter a~     four-week single-blind, placebo run-in period following which each subject will be randomised~     into a 2 year double-blind treatment phase. The total study duration for each subject will be~     up to 110 weeks.~   "
115294|NCT02058355|"~     This project aims to develop and evaluate the effectiveness of an Personalized Normative~     Feedback (PNF) intervention via the internet, through a randomized clinical trial for alcohol~     consumption among Brazilian college students, as well as evaluating the most effective~     components of the PNF (normative and list of consequences). The sample is composed of college~     students aged between 18 and 30 years. Participants allocated into four different groups:~     control, full intervention (PNF), feedback with normative components (FN) and feedback with~     list of consequences (FLC). The investigators will use the dismantling design to study the~     most effective components. Participants will be followed-up at 1, 3 and 6 months.~   "
115308|NCT02058173|"~     The purpose of this study is to assess the efficacy of Chloroquine comparing with placebo for~     treatment of non- response HCV patients.. In this triple blind pilot study, 20 patients with~     confirmed chronic hepatitis C will be randomize into treatment group (Chloroquine 150 mg~     daily, for 8 weeks) or control group (placebo once daily, for 8 weeks). Patients who have~     receiving anti neoplastic, anti viral or Immunomedullator drugs during 6 months prior to~     study, have co-infection Hepatitis A,C,D or HIV, severe liver or renal dysfunction, are~     pregnant or breast fed, or refuse to sign informed consent will be excluded.. At the end of~     therapy (12 weeks) and at baseline, first, second and third month after receiving drug and~     placebo HCV Virus load, CBC LFT and biochemical parameters will be evaluated and compared~     between groups.~   "
115295|NCT02058342|"~     Compared to other children, those with disability have additional challenges to being~     physically active. Prader-Willi Syndrome (PWS) is a genetic form of childhood obesity that is~     characterized by hypotonia, growth hormone deficiency, behavioral, and cognitive disability.~     In children, the low prevalence of PWS (1 in 10,000 to 15,000 live births) makes group-based~     physical activity (PA) interventions impossible. In contrast, the home environment presents a~     natural venue to establish a PA routine for this population. The present high prevalence of~     non-syndromal childhood obesity (one in four) and high physical inactivity rates, make~     alternative approaches to increasing PA in this population an area of high interest.~     Therefore, we have developed a 24-week home-based physical activity that could be suitable~     for children and adolescents ages 8-15 with PWS as well as obese children without PWS ages~     8-11 years. It is hypothesized that: 1) an age-appropriate 24-week home-based PA intervention~     will increase PA levels in youth with PWS and without the syndrome but with obesity; 2) motor~     proficiency, central sensory reception and integration, and body composition will~     significantly improve in youth with and without PWS following completion of the home-based PA~     intervention and 3) physical activity self-efficacy and quality of life will increase~     significantly in youth with and without PWS who complete the home-based PA intervention. The~     study participants are 115 youth ages 8-15 y (45 with PWS and 70 without PWS but categorized~     as obese). The study utilizes a parallel design with the wait-listed control group receiving~     the intervention after serving as control. Participants are expected to complete the PA~     curriculum 4 days a week for six months including playground games 2 days a week and~     interactive console games 2 days a week. Parents are trained at baseline and then provided~     with a PA curriculum (Active Play at Home) and equipment to guide their implementation of the~     program at home. Measurements of children and parent dyads are assessed at baseline and at~     the end (week 24) of the intervention or control periods. Outcome measures include PA, body~     composition, motor proficiency, central sensory reception and integration (subsample of~     children only), quality of life and physical activity self-efficacy. PA intervention~     compliance is monitored using mail-in daily self-report checklists.~   "
115296|NCT02058329|"~     The overall goal of the project is to reduce the incidence of post hip fracture morbidity and~     mortality by conducting geriatric fellow periodic home visits.The assessment will be~     multidisciplinary and will include assessments of functional status, depression,~     environmental risks and medical conditions. This group will be compared against a group~     followed by the usual standard of care post hip fracture.~   "
115297|NCT02058316|"~     Background Invasive pulmonary aspergillosis (IPA) remains an important cause of morbidity and~     mortality among patients with hemato-oncological malignancies. Due to the crude mortality of~     >90% in absence of adequate treatment, timely diagnosis and early start of antifungal therapy~     are key factors in the successful treatment of IPA. Various studies have shown that early~     initiation of antifungal therapy may improve IPA survival to above 70%. Diagnosis of IPA,~     however, remains difficult as clinical signs and symptoms as well as radiological findings~     are often unspecific and conventional culture methods lack sensitivity. In recent years~     antigen testing has therefore become one of the cornerstones of IPA diagnostics.~     Brochoalveolar lavage (BAL) Galactomannan (GM) testing is currently the most promising~     approach for early detection of pulmonary infections by this fungus. However, limitations of~     GM detection are assay turn-around time, which varies widely between centers (less than a day~     to several days), and the need for appropriately equipped laboratories that routinely test~     for this antigen. These limitations are overcome by the Aspergillus Lateral-Flow Device~     (LFD), a novel point-of-care (POC) test for IPA diagnosis developed by Dr Thornton at the~     University of Exeter, UK. This simple, rapid (15 min), single-use test can be performed in~     rudimentary facilities using BAL specimens. In a retrospective single centre study we have~     recently evaluated the LFD test in 39 BAL samples from hematologic malignancy patients and~     solid organ transplant recipients. Sensitivities and specificities of BAL LFD tests for~     probable IPA were 100% and 81%, respectively. Galactomannan levels in cases with negative LFD~     were significantly lower than in patients with positive LFD (P <0.0001). We concluded that~     the LFD test of BAL specimens is performed easily and provides accurate and rapidly available~     results. Therefore, this new point-of-care test may be a very promising diagnostic approach~     for detecting IPA in BAL specimens from haematological malignancy and SOT patients. For~     routine clinical use, however, multicenter studies with larger sample sizes also from other~     patient collectives are necessary. In this multicenter study we will evaluate the LFD test in~     BAL samples.~      Study Objectives Primary Objectives To evaluate the Lateral Flow Device test, a rapid (15~     min), point-of-care test for IPA diagnosis using bronchoalveolar lavage (BAL) fluids from~     patients at risk for IPA.~      Secondary Objective To evaluate the potential of BAL Lateral Flow Device test for prognosis~     in patients with IPA.~      Study Design This is a prospective multi-center study conducted in three centers in Austria~     (Graz, Vienna and Innsbruck) and one centre in Germany (Mannheim). In order to meet the~     objectives an estimated number of 300 BAL samples from patients at risk for IPA (50 to 100~     per centre) will be included in the study cohort. The Lateral Flow Device test will be~     performed prospectively in BAL samples from the patients and results will be compared to GM~     results, PCR findings, clinical/radiological findings as well as conventional culture~     results. In addition, retrospective testing of BAL samples that were previously routinely~     tested for GM will be performed in up to three participating centers (Graz, Innsbruck and~     Mannheim) to ensure to reach the proposed number of 300 BAL samples. The treating clinicians~     will not be informed about BAL Lateral Flow Device test results and the test will therefore~     have no impact on patient management / treatment decisions.~   "
115298|NCT02058303|"~     The purpose of this study is to compare Exparel, a new, long-lasting numbing medication and a~     shorter-acting nerve block to a traditional single-shot nerve block in patients having hand,~     wrist or finger surgery.~   "
115299|NCT02058290|"~     This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome~     injectable suspension) to determine if total opioid consumption is reduced when using~     EXPAREL, therefore possibly reducing total hospital costs.~   "
115300|NCT02058277|"~     This is an open label, randomized, single dose, one cohort, two sequence, two period~     crossover study in healthy subjects. The primary objective of the study is to evaluate the~     effect of a single oral dose of aprepitant on the pharmacokinetic (PK) profile of a single~     oral dose of bosutinib in healthy subjects.~   "
115301|NCT02058264|"~     The purpose of this study is to determine the safety, tolerability, pharmacokinetics and~     treatment effect of BBI-4000 when topically applied to subjects with axillary hyperhidrosis.~   "
115302|NCT02058251|"~     In comparison to the general population, military personnel and veterans are at increased~     risk of developing both substance use disorders (SUDs) and post-traumatic stress disorder~     (PTSD). Despite promising developments in the past decade, the treatment of patients with~     SUDs and comorbid PTSD is woefully inadequate (Back, 2010; Back et al., 2014; Brady et al.,~     2007; McCauley et al., 2012). One of the adverse effects of abused drugs is their long-term~     negative impact on social behavior that is thought to involve oxytocin (OT) dysregulation~     (McGregor et al., 2008). In preclinical and clinical experiments, local, intra-nasal, or~     systemic OT administration decreases activation of the amygdala in response to visual~     fearful/threatening stimuli (Kirsch et al., 2005), ameliorates the effects of stressful~     events, and decreases drug-taking and seeking behavior (McGregor et al., 2008; Baskerville~     and Douglas, 2010; Carson et al., 2010a; Bowen et al., 2011; Cox et al 2013). However, little~     attention has been focused on whether OT decreases SUD vulnerability after exposure to~     traumatic stress in preclinical or clinical studies. This clinical project will determine~     whether intra-nasally administered OT will decrease craving (Aim 1) to use alcohol and~     decrease stress reactivity (Aim 2) following exposure to laboratory-induced stress (Trier~     Social Stress Task) among veterans with a dual diagnosis of alcohol use disorder and PTSD.~   "
115303|NCT02058238|"~     To quantify potential short- and long-term benefits of robotically-guided minimally invasive~     (MIS) or open-approach spine surgery in adult patients undergoing multi-level spinal~     instrumentation surgery, in comparison to image- or navigation-guided instrumentation in a~     matching cohort of control patients, performed using a freehand technique, both in MIS and~     open approaches.~   "
115304|NCT02058225|"~     The purpose is to study the effect of infant nutrition on brain development, as measured~     using Magnetic Resonance (MR) techniques. The investigators will collect detailed information~     about the diet of each of the infants, and seek to correlate this information with multiple~     MR measurements, including structural imaging, diffusion imaging, and functional~     connectivity. The MR scans will be performed at birth and 3 months of age. Dietary~     information collected will include detailed food diaries describing the feeding habits of the~     infants, and food frequency questionnaires to characterize the diet of the mother.~   "
115305|NCT02058212|"~     ROS plays an essential role in the pathogenesis of many reproductive processes. High~     follicular fluid ROS levels are associated with negative IVF outcomes.~      is plasma level of reactive oxygen species is affected by antioxidant treatment in~     endometriotic women?~   "
115306|NCT02058199|"~     The investigators are attempting to compare the anticoagulant (blood thinning) effects of a~     recently FDA approved medication, Rivaroxaban, in people who have undergone gastric bypass~     surgery to people who have not had this surgery. It is thought that gastric bypass may alter~     the absorption of this medication, but this has not been previously studied.~      The investigators will study the anticoagulant effect of rivaroxaban in healthy volunteers~     who are in one of four groups~        1. Non obese people who have not had a gastric bypass.~        2. Obese people who have not had a gastric bypass~        3. People who have had a gastric bypass~        4. People who are planning to undergo gastric bypass surgery in the near future who are~          willing to be studied before and after the bypass.~      The study will involve taking a single low dose of rivaroxaban and multiple blood samples~     will be taken over the next 24 hours and the effect of rivaroxaban on blood clotting will be~     measured using the prothrombin time and an anti-factor Xa assay. The effects of rivaroxaban~     will be compared between the different groups.~   "
115333|NCT02057848|"~     Backgrounds/Aims: It was the aim to prospectively study the optimum regime of preventive~     carbohydrate administration for prevention of hypoglycaemic episodes during a standardized~     bout of physical activity.~   "
115309|NCT02058160|"~     Primary Objective:~      To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination~     (FRC) to insulin glargine in glycated hemoglobin (HbA1c) change from baseline to Week 30.~      Secondary Objective:~      To compare the overall efficacy and safety of insulin glargine/lixisenatide FRC to insulin~     glargine (with or without metformin) over a 30 week treatment period in participants with~     type 2 diabetes.~   "
115310|NCT02058147|"~     Primary Objective:~      To compare the insulin glargine/lixisenatide fixed ratio combination to lixisenatide alone~     and to insulin glargine alone (on top of metformin treatment) in glycated hemoglobin (HbA1c)~     change from baseline to Week 30.~      Secondary Objective:~      To compare the overall efficacy and safety of insulin glargine/lixisenatide fixed ratio~     combination (FRC) to insulin glargine alone and to lixisenatide alone (on top of metformin~     treatment) over a 30 week treatment period in participants with type 2 diabetes.~   "
115311|NCT02058134|"~     The purpose of this study is to determine whether intra- and postoperative use of the~     cardioPAT® cell saver decreases the need for allogenic red blood cell transfusion in~     patients, who undergo open heart surgery (with cardiopulmonary bypass) and preoperatively~     have an increased risk for bleeding.~   "
115312|NCT02058121|"~     The purpose of this study is to test if an ACT group intervention focusing on body image~     enhances recovery and reduces relapse in patients treated at a specialised eating disorder~     unit.~   "
115313|NCT02058108|"~     The purpose of the study is to assess the efficacy and safety of telbivudine at a dose of 20~     mg/kg up to a maximum of 600 mg q.d. in compensated pediatric HBeAg-positive and negative CHB~     patients aged 2 to <18 years with the indication of antiviral CHB treatment. This study is~     part of the commitments of the pediatric development plan for telbivudine in Europe and US.~   "
115314|NCT02058095|"~     To determine the effect of 12 weeks of chronic PDEV inhibition with Tadalafil versus placebo~     on basal cardiorenal and humoral function and on the integrated cardiorenal and humoral~     response to acute sodium loading in subjects with preclinical Diastolic dysfunction (PDD) and~     renal (kidney) dysfunction~   "
115315|NCT02058082|"~     The purpose of this study is to determine whether couples undergoing IVF/ICSI with male~     factor infertility, specifically with elevated sperm DNA damage, should testicular sperm~     extraction be utilized to improve their reproductive outcomes.~   "
115316|NCT02058069|"~     The Investigation will be conducted as a single-submission, multi-center study with approval~     from and in compliance of the Western Institutional Review Board (WIRB).~      The overall objective of this Investigation is to assess the safety and effectiveness of the~     Robotic Arm Interactive Orthopedic System (RIO) Total Knee Arthroplasty Application.~     Specifically, the study objectives are classified as follows:~        -  Primary Objective: Surgeon assessment of standardized TKA complications both~          intra-operatively and at short term follow up.~        -  Secondary Objective: Radiographic assessment of post-operative limb alignment.~        -  Supporting Objective: Patient assessment of post-operative function and satisfaction.~   "
115317|NCT02058056|"~     The main objective of this trial is to assess NCF after early HA-PCI concomitant to the~     second cycle of CHT and to tRT for patients with LD SCLC.~   "
115318|NCT02058043|"~     DESCRIPTION OF RELATED QUESTION Cognitive disorders are frequently encountered and present a~     major public health problem given the aging of the population.~      There is not one, but several neurodegenerative pathologies individual differentiated.~      Particularly distinguished is Alzheimer's disease (the most common), dementia lobar~     fronto-temporal associated with semantic dementia (a disease with a particular tropism for~     semantic memory and the anterior temporal lobe), and dementia with Lewy bodies.~      To differentiate these pathologies is, for the clinician, is a major issue and the clinic may~     not be enough.~      The management and current diagnostics of atypical cognitive disorders, that is to say,~     patients with clinical symptoms or neuropsychological testing results suggestive of a~     neurodegenerative disorder other than Alzheimer's disease, are based largely on data imaging.~      In the first intention, conducting imaging by MRI is recommended by the HAS, particularly to~     search for treatable causes to these cognitive disorders (tumors, intracranial hemorrhage in~     particular) but also to study the distribution of cerebral atrophy.~      The sequences used are the sequences 3D T1, axial Flair, gradient echo axial T2 and coronal~     T2 in the plane of hippocampi and also diffusion imaging.~      Research has shown interest in the study of cerebral perfusion in cognitive disorders.~      The HAS recommends not to inject contrast medium on MRI in this context. The sequence of~     perfusion by tagging arterial protons or arterial spin labeling (ASL) does not use~     exogenous contrast medium. This is available as a commercial product, CE marked, on most of~     the recent clinical MRI scanners. This non-invasive technique, requiring no special~     precautions (e.g. verification of renal function) is used in routine clinical practice at the~     University Hospital of Rennes and in many centers. In the imaging of patients with dementia,~     it is widely used as well as the 3D T1 sequences or diffusion imaging (International~     Initiative ADNI) and is subject to optimization and harmonization of use in routine clinical~     practice with the European COST AID actions.~      The second intention, an isotope imaging by FDG-PET or study of perfusion SPECT can also be~     performed. The interest of isotopic imaging (FDG-PET and SPECT) lies in the provision of~     information metabolic nonexistent in MRI, with a superiority of FDG-PET compared with SPECT.~     FDG-PET is the preferred examination and is carried out at CRLCC Eugène Marquis de Rennes in~     this context.~      The aim of our study is to compare the imaging of TEPFDG, a technique not morphological, and~     ASL that, even if they do not study the same mode (metabolism for the first and perfusion for~     the second) may depict consistent anomalies.~   "
115319|NCT02058030|"~     Background - The purpose of the present study is to evaluate the success and pharyngeal~     trauma when 3 or 6 cm height of pillow is used for the ProSealTM laryngeal mask airway~     insertion~      Methods~      - This prospective randomized, controlled study included 80 adult patients . In the 3 cm~     (n=40) or 6 cm group (n=40), the PLMA was inserted while the head is placed on the 3 cm or 6~     cm height of pillow. The success rate at first and second attempt, insertion time, blood~     staining on cuff, sore throat and hoarseness were assessed.~   "
115320|NCT02058017|"~     This is a lead-in dose escalation study to determine the safety, tolerability,~     pharmacokinetics, maximum tolerated dose (MTD), and recommended Phase II dose of OPB-51602~     administered on a weekly basis in subjects with advanced malignancies. Using the recommended~     phase II dose, the efficacy and tolerability of OPB-51602 administered prior to definitive~     chemoradiotherapy will be evaluated in locally advanced NPC patients. This study's~     overarching goal is the development of STAT3 inhibitors as a novel class of anti-cancer~     agents and the optimization of patient selection for STAT3 inhibitor therapy through parallel~     biomarker studies. This study hopes to establish a therapeutic window for OPB-51602 in solid~     tumours and will evaluate its potential as a targeted therapy of NPC, since this represents a~     critical unmet clinical need. The development of predictive and pharmacodynamic biomarkers in~     tandem with the clinical evaluation of OPB-51602 will be crucial to its therapeutic~     advancement and will enable an understanding of the genetic contexts of responsiveness and~     resistance to OPB-51602, which can in turn lead to the development of effective drug~     combinations to overcome resistance.The study hypothesizes that OPB-51602, a first-in-class~     STAT3 inhibitor, is efficacious in solid tumours with constitutively activated STAT3, such as~     NPC.~   "
115321|NCT02058004|"~     In modern anesthesia practice, the application of cricoid pressure during intubation is not~     infrequently used with the goal of preventing gastric-to-pulmonary aspiration. The evidence~     to support this practice is very scarce, and there have recently been many reports in the~     literature questioning the safety of cricoid pressure during intubation. Therefore, the goal~     of this study will be to randomize those at risk for microaspiration to receive cricoid~     pressure versus no cricoid pressure during intubation. We will specifically exclude those~     patients thought to be at the highest risk of aspiration (it is considered standard of care~     to perform cricoid pressure during intubation of this population). We will include those~     patients with some risk factors for aspiration (it is not considered standard of care to~     apply cricoid pressure during intubation of this population).~   "
115322|NCT02057991|"~     This randomized pilot trial studies mindfulness-based program in educating patients with~     colorectal cancer and their caregivers. A mindfulness-based exercise video may help reduce~     stress and fatigue in patients with colorectal cancer and their caregivers.~   "
115323|NCT02057978|"~     The purpose of this Randomized Study to evaluate the safety and efficacy of the Excel-II DES~     compared to the EXCEL DES in the treatment of patients with de novo coronary artery lesions.~   "
115324|NCT02057965|"~     This study will test the hypothesis that MSCs in combination with Everolimus facilitate~     Tacrolimus withdrawal, reduce fibrosis and decrease the incidence of opportunistic infections~     compared to standard tacrolimus dose.~   "
115325|NCT02057952|"~     The main objective for this project is to identify effective methods of treating obesity in~     at-risk populations. The investigators will be comparing weight loss from usual care, in~     person, and video conference weight loss programs. The investigators will follow 210~     participants for 12 months to see if they lose and maintain 2kg of weight. The investigators~     will also compare the costs of video conference versus in person administered programs.~      Potentially eligible participants will be identified based on data in the Regenstrief Medical~     Records System or by referral from the Wishard HealthyMe weight loss program staff or a~     Wishard Community Health Center (CHC) primary care provider. The PBRN staff will carry-out~     initial recruitment. Following consent, a baseline assessment will be performed and each~     participant will be randomized into one of three groups: usual care control, in person weight~     loss or online video conference weight loss. At 6 and 12 months a follow up assessment will~     be performed and compared to measures from the investigators baseline assessment. Total costs~     for each program will be compared as well.~      The weight loss interventions involve group meetings two times per week where education,~     exercise, and social support are provided. Participants will also receive a detailed~     education booklet. Those randomized to the in-person group will meet in the CHC and those in~     the video-conference group will meet online in a multi-party video-conference. All~     participants will receive usual CHC care.~   "
115326|NCT02057939|"~     The purpose of this study is to describe the 2 year progression-free survival in men with~     recurrent PSA-only disease after prostatectomy receiving combined enzalutamide and standard~     androgen-deprivation therapy (ADT) with salvage radiation therapy. Eligible men will have~     recurrent PSA-only prostate cancer within 4 years of prostatectomy, and a PSA of 0.2 - 4 in~     the absence of metastatic disease on CT and bone scans. In addition to standard ADT and~     radiation therapy, research participants will take enzalutamide once daily for six months. It~     is primarily hypothesized the 2 year PFS rate will be improved with the combined therapy~     compared to the historical control data in a similar patients setting.~   "
115327|NCT02057926|"~     The main objective of this study was to evaluate the histological impact of treatment with~     tetracycline (TTC) solution of two layers collagen membranes (CMs) bio-degradation, in ridge~     preservation technique (RPT). Additionally, secondary objectives were to evaluate the effect~     of TTC on bacterial colonization and inflammatory response. This is a randomized simple-blind~     clinical trial. Consecutive patients referred to the Department of Periodontology at~     Universitat Internacional de Catalunya (Barcelona, Spain), between November 2009 and April~     2011, were included in the study. This study was based on data collected from 20 surgical~     sites in 10 systemically healthy patients requiring 2 extractions with SPT. Before starting~     the surgery, the two teeth of each selected patient were randomized in two groups. The test~     group underwent RPT with CMs embedded with TTC solution (CMs TTC), and the control group was~     performed without TTC solution (CMs NO TTC). Randomization was performed using SPSS software~     (version 18, SPSS Inc., Chicago, IL, USA). In the test group, both membranes were first~     dipped for 5 minutes in TTC solution (50 mg/ml). This involved the use of 250 mg tablets of~     TTC and 5 ml of saline that were mixed in a sterile trough. A sample of the membrane used in~     each SPT was retained as a negative control sample. The membrane sample was retrieved 7 days~     after initial surgery. At 14 days the suture was removed and a new control was performed~     within 1 month. A sample from the negative control, test and control group was analyzed from~     each patient. The specimens were fixed in a 10% formalin solution, dehydrated in a series of~     alcohols, embedded in paraffin, and sectioned in 4-5μ. The sections were stained with~     hematoxylin and eosin and examined with an Olympus BH-2 optical microscope. The stained~     sections were photographed with a digital camera mounted on an optical microscope at~     magnification (x100, x200 and x400). According to the findings of the present study, we can~     conclude that CMs exhibit rapid degradation when exposed to the oral environment.~     Histological interpretation suggests that CMs immersed in 50mg/ml TTC solution delay the CM~     degradation when exposed to the oral environment. Statistical evaluation did not show any~     difference in bacterial colonization and inflammatory response, but the findings may also be~     affected by the limited sample size.~      The limits of the present study are the absence of histomorphometric analysis, the sample~     size, and the lack of a long-term evaluation with clinical evidence of the advantages of this~     technique. More clinical studies in humans are require to confirm the effect of TTC in CMs~     degradation before we can make recommendations.~   "
115328|NCT02057913|"~     VinCaP is a multicentre single-arm phase II trial. 22 patients will receive Vinflunine~     chemotherapy (Vinflunine 320mg/m2 given intravenously on day 1 of each cycle of 21 days, four~     cycles to be given prior to formal re-staging).~   "
115329|NCT02057900|"~     The purpose of the study is to assess the feasibility and safety of a transplantation of~     cardiac-committed progenitor cells derived from human embryonic stem cells in patients with~     severe heart failure.~   "
115330|NCT02057887|"~     The purpose of this study is to evaluate the safety and tolerability of multiple ascending~     doses of HM10660A in subjects with chronic hepatitis C(HCV).~   "
115331|NCT02057874|"~     This pilot clinical trial examines how well different imaging biomarkers acquired using~     3-Telsa magnetic resonance imaging (MRI) methods perform in determining treatment response to~     transarterial chemoembolization (TACE) in patients with hepatocellular carcinoma. Compared to~     conventional imaging, multi-parametric 3-Tesla MRI offers the ability to quantitatively~     measure tissue structural, functional, cellular, and molecular properties, providing a more~     robust, clinically relevant method for assessing cancer response to therapy.~   "
115332|NCT02057861|"~     In this study the investigators aimed to compare the time of antagonism and intensity of~     effect of sugammadex which is used for antagonism of rocuronium on diabetic and non-diabetic~     patients.~   "
115335|NCT02057822|"~     The ocular surface may be the seat of an inflammatory process in many pathology as vernal~     keratoconjunctivitis. It has been shown that inflammatory cytokines produced by the cells~     themselves and the constituent cells of the target organ, are the main factors that cause~     inflammation. The main objective of our study was to compare the concentration of 40~     cytokines in vernal keratoconjunctivitis and in control subjects.~   "
115336|NCT02057809|"~     Developmental disability is a severe chronic disabled condition caused by mental or physical~     impairments. Children with developmental disabilities may face life-long difficulties in~     motor functioning, self-care, condition, communication, and independent living. They often~     receive rehabilitation services to promote daily functions and participation in home, school,~     and community lives.~      Family-centered service has been considered as best practice in pediatric rehabilitation.~     Therapists encourage children with developmental disabilities and their parents to~     participate in decision making and implementing process of intervention, and provide~     intervention plan that best fit their family needs. Research shows that for children with~     developmental disabilities, family-centered services can enhance children's development,~     decrease parenting stress, promote emotional wellness, and increase parental satisfaction to~     services. Though the family-centered concept has been considered as relevant in pediatric~     rehabilitation, there are still difficulties, as well as a lack of evidence regarding its~     implementation in practice.~      Reflecting the trend of family-centered medical care, the benefits of national health~     insurance in Taiwan for early intervention outpatient care will emphasize on family-centered~     intervention. The range of benefits may include communication with parents, parental~     education, consultation and instructions for home programs. Besides, outcomes of~     family-centered intervention will be treated as an important index for monitoring the quality~     of medical services.~      Given that there is a lack of investigation regarding the family-centered pediatric~     rehabilitation, the purposes of this one-year research project are to investigate the~     implementation of family-centered pediatric rehabilitation for children with developmental~     disabilities and to identify related influencing factors. This study will provide empirical~     evidence for family-centered services in Taiwan.~   "
115337|NCT02057796|"~     In countries with a high tuberculosis (TB) prevalence, TB and invasive bacterial infections~     are leading causes of early death in patients who initiate antiretroviral therapy (ART) with~     advanced immunodeficiency.~      We hypothesize that a systematic 6-month empirical TB treatment initiated 2 weeks before the~     introduction of ART in HIV-infected adults with severe immunosuppression (CD4<100/mm3) and no~     overt evidence of TB will reduce the risk of death and invasive bacterial infections. This~     strategy will be compared to one of extensive TB testing using point-of-care tests (Xpert~     MTB/RIF® and urine lipoarabinomanan LAM) and chest X-ray to identify and treat only patients~     with at least one positive test suggestive of TB.~   "
115338|NCT02057783|"~     Investigators hypothesize that CPAP treatment for suppressing OSAS in combination with a~     physical activity program will optimize 24-hour blood pressure control in patients with~     OSA-related resistant hypertension.~   "
115339|NCT02057770|"~     The purpose of this research study is to look at overall health status and how acute myeloid~     leukemia (AML) responds to a stem cell transplant when followed with cyclophosphamide. Some~     participants enrolling in this study may receive a transplant from a sibling, some may~     receive a transplant from a matched unrelated donor, and some may receive what is called a~     haploidentical transplant. A haploidentical stem cell transplant is a type of transplant that~     occurs when a person who needs a transplant cannot find a donor who exactly matches their~     tissue type (either among family members or through a matched unrelated donor). When no~     matched donor is available, half-matched related (haploidentical) donors may be used.~     Haploidentical donors are first degree relatives such as siblings, children, or parents.~      People who undergo a stem cell transplant can experience complications such as rejection of~     the stem cell transplant or severe graft-versus-host disease (GVHD). GVHD occurs when some of~     the cells from the donor attack the recipient's tissues, resulting in mild, moderate, or even~     life-threatening side effects to the recipient's skin, stomach, intestines, and liver.~     However, recent research has shown that receiving cyclophosphamide after stem cell transplant~     can improve the outcomes of the transplant, and that is the purpose of this study.~   "
115340|NCT02057757|"~     Respiratory viruses are a significant cause of hospitalization for respiratory tract~     infections. This study will evaluate the safety, effectiveness, and tolerability of~     nitazoxanide (NTZ) in treating severe acute respiratory illness (SARI) in people who are~     hospitalized.~   "
115341|NCT02057744|"~     To quantify potential short- and long-term benefits of robotically-guided minimally invasive~     spine surgery (MIS) for adult patients with lower back degeneration, in comparison a matching~     group of control patients operated in a minimally invasive approach whether freehand or with~     image guidance or navigation techniques.~   "
115342|NCT02057731|"~     The purpose of the study is to determine whether carrier status for any type of glycogen~     storage disease (GSD) predisposes the carrier to GSD markers, like high cholesterol, by~     testing blood, urine, and saliva samples.~   "
115343|NCT02057718|"~     This is an open label study in children with Progressive Familial Intrahepatic Cholestasis~     (PFIC) designed to evaluate the safety and efficacy of LUM001. Efficacy will be assessed by~     evaluating the effect of LUM001 on pruritus and the biochemical markers of pruritus~     associated with PFIC.~   "
115344|NCT02057705|"~     This is a prospective, non-interventional, longitudinal study of the natural history and~     function of approximately 60 patients with MTM from the United States, Canada and Europe. The~     duration of the study, including the enrollment period, will be 36 months. Data from the~     study will be used to characterize the disease course of MTM and determine which outcome~     measures will be the best to assess the efficacy of potential therapies.~   "
115345|NCT02057692|"~     The study is a randomized, double-blind, placebo-controlled study in children with Alagille~     Syndrome (ALGS). The study will investigate the effects of LUM001, compared to placebo, on~     pruritus, serum bile acids, liver enzymes, and other biochemical markers in patients with~     ALGS.~   "
115356|NCT02057536|"~     The objective of this study is to determine if patients taking aromatase inhibitors (AI), who~     are experiencing joint discomfort and stiffness, would have reduction in this discomfort and~     stiffness by participating in a directed exercise program. The overarching objective is to~     improve patient compliance with the medication and ultimately clinical outcome.~      In this pilot study, we will utilize a scientific approach for proof of concept employing~     both objective (inflammatory cytokine profiles and Physical Therapy (PT) measurements) and~     subjective (patient perception) methods to support an evidence based clinical plan. Patients~     will be divided into two cohorts. Group A will receive AI therapy with a directed exercise~     program. Group B will receive AI therapy without a directed exercise program. Data will be~     collected when both cohorts of patients enroll in the study, at the end of PT for Group A~     and, at the end of 8 weeks for Group B. At these time points, both groups will undergo a PT~     evaluation; have blood drawn for cytokine profiles; answer questions on an iPad that~     includes: the Pain Disability Index, the PHQ-4 (Psycological Health Questionaire depression~     scale, and pain level scale.~   "
115346|NCT02057679|"~     Acute cholecystitis (AC) is a very common complication of cholelithiasis, encountered in 20%~     of symptomatic patients.~      Nowadays laparoscopic cholecystectomy (LC) is the standard treatment in mild and moderates~     forms of diseases and antibiotic therapy in the postoperatory of these patients remains under~     discussion. However in the beginning, AC presents itself as an steril process, the~     obstruction of the cystic duct initiates a cascade of inflammation, ischaemia and necrosis,~     as well as bacterial proliferation within the gallbladder lumen. Bactibilia was a significant~     factor associated with total, as well as infectious, operative complications. Regarding this,~     for some authors, monotherapy with amoxicillin clavulanic (AMC) would be the best treatment~     after LC in patients with mild and moderate cholecystitis without intraoperative~     complications such as bile peritonitis, cholangitis, gallbladder perforation or abscess. In~     the other hand, others do not prescribe antimicrobial treatment after surgery in these~     selected patients.~      There is controversy regarding the postoperative treatment with antibiotics in patients with~     mild and moderate cholecystitis and all the evidence about this topic.~      Therefore, investigators decided to conduct a prospective randomized study in patients~     undergoing laparoscopic cholecystectomy for acute mild and moderate cholecystitis cancer. The~     patients will be randomized to receive AMC or placebo after surgery. With this study~     investigators intend to prove that are no clinical differences in postoperative outcomes~     between patients treated with AMC and placebo.~      The primary aim of the trial is to assess that there are no benefits in the use of~     postoperative antibiotics in patients whit mild or moderate acute cholecystitis in whom a~     laparoscopic cholecystectomy was performed.~   "
115347|NCT02057666|"~     To confirm the effect of tasquinimod in delaying disease progression or death as compared~     with placebo in chemo-naïve patients with metastatic castrate-resistant prostate cancer~     (mCRPC).~   "
115348|NCT02057653|"~     As part of a quality assurance program, the Department of Anesthesiology implemented a~     Goal-Directed Fluid Management training course for all physicians and nurses to provide~     goal-directed fluid management. We intend to assess whether there has been any improvement in~     patient outcomes by analyzing de-identified clinical information that are readily available~     via the medical center electronic medical record system. The time-frame we are interested in~     is one year before and one year after the Goal-Directed Fluid Management training curriculum~     (June 15, 2011 to September 15, 2013).~   "
115349|NCT02057640|"~     This study will look at the safety and tolerability of the new drug MLN9708 in combination~     with the existing drugs panobinostat and dexamethasone among patients with relapsed or~     refractory multiple myeloma. This study will also look at the response and clinical benefit~     of the treatment and the progression-free survival and overall survival of study~     participants.~   "
115350|NCT02057627|"~     Maternal depression and mother-infant relationship dysfunction have reciprocal effects on~     each other. An integrated approach addressing both problems simultaneously may improve~     outcomes. Perinatal Dyadic Psychotherapy (PDP) was developed to prevent/decrease postpartum~     depression and facilitate optimal mother-infant relationships. The purpose of this pilot~     study is to determine the feasibility, acceptability, and preliminary efficacy of PDP.~     Depressed first-time mothers (meeting diagnostic criteria for depression and/or with high~     depression symptom levels) and their 6-week-old infants will be randomized to receive either~     the PDP intervention or a control condition. The PDP intervention consists of 8 home-based,~     nurse-delivered mother-infant sessions consisting of (a) a supportive, relationship-based,~     mother-infant psychotherapeutic component, and (b) a developmentally based infant-oriented~     component focused on promoting positive mother-infant interactions. Control mothers will~     receive usual care plus depression monitoring by phone. Data will be collected at baseline,~     post-intervention, and 3 month follow-up. Assessments included maternal depression (diagnosis~     and severity), maternal anxiety (diagnosis and severity), parenting stress, and mother-infant~     interaction.~   "
115351|NCT02057601|"~     The purpose of this study is to determine that periarticular levobupivacaine infiltration~     after surgical fixation of fractured neck of femur will improve the early postoperative pain~     sensation.~   "
115352|NCT02057588|"~     The objective of this study will be to evaluate the ability of IEGMs (Signal recorded from~     implanted pacing leads) and pseudo ECGs (derived from various IEGMs) to characterize various~     electrical conduction patterns. Electroanatomic mapping data and 12 Lead ECG will also be~     collected to characterize electrical conduction patterns during standard electrophysiology~     exam.~   "
115353|NCT02057575|"~     To evaluate the ocular hypotensive efficacy of PG324 ophthalmic solution relative to its~     individual components in patients with open angle glaucoma or ocular hypertension.~   "
115354|NCT02057562|"~     Benign adenomas of the colon have the potential to degenerate and become malignant. Therefore~     adenomatous polyps should be detected and resected during colonoscopy. Factors like advanced~     age and male gender are associated with the detection of adenomas. The same epidemiological~     pattern can be found with regard to colon diverticula. Furthermore, western world countries~     report higher incidences of both colorectal carcinoma as well as diverticular disease. It is~     not known whether a correlation exists between both entities. Some recent data have~     postulated higher adenoma detection rates in patients with concomitant diverticular disease~     (Rondagh EJ et al. Eur J Gastroenterol Hepatol. 2011; 23:1050-5. Kieff BJ et al. Am J~     Gastroenterol 2004; 99: 2007-11). If a positive correlation could be found this would~     possibly affect recommendations regarding colonoscopy surveillance intervals for patients~     with and without diverticular disease. The investigators therefore plan to conduct the~     following trial.~   "
115355|NCT02057549|"~     Randomized controlled trial comparing haloperidol combined with conventional therapy and~     conventional therapy alone in patients with symptomatic gastroparesis.~   "
115357|NCT02057523|"~     The goal of this study is to evaluate the benefit of ACTH (Acthar) in reducing proteinuria~     associated with transplant glomerulopathy in non-diabetic kidney transplant recipients.~   "
115358|NCT02057510|"~     The purpose of this study is to measure the two-year rate of tooth loss in patients who have~     received external beam radiation therapy with curative intent for head and neck cancer. The~     study will also evaluate the sequelae of radiation therapy and oral complications that may~     occur as a result to receiving radiation therapy.~   "
120870|NCT01985386|"~     Slow release iron capsules containing ferrous sulfate have been designed based on the gastric~     delivery system. Iron absorption from those capsules administered with and without meals will~     be measured using stable iron isotopes.~   "
115359|NCT02057497|"~     G (guanine nucleotide binding) proteins associating with G protein-coupled receptors (GPCR)~     are key players in the pathogenesis of obesity and diabetes and are targets of~     pharmacotherapeutic inter-ventions. In addition, G proteins binding to GPCRs either directly~     or permissively determine the efficacy of lifestyle interventions and drugs aiming at weight~     management and diabetes treatment. Polymor-phisms of the fat mass and obesity-related protein~     (FTO) gene have been also well characterised and linked to energy intake, body fat mass as~     well as CVD risk and the susceptibility to weight-reducing interventions. Stratifying~     patients according to G protein and FTO-related genotyping may enable a more accurate~     prediction of individual disease courses and responses to therapeutic interventions in terms~     of safety and tolerability as well as efficacy. Although the objectives primarily refer to~     the analysis of G pro-tein and FTO-related genotypes, also other genes of potential relevance~     for the evolution of obesity and/ or diabetes and the response to lifestyle and~     pharmacological interventions may be analysed.~   "
115360|NCT02057484|"~     The purpose of this study is to evaluate the impact of Advagraf, prolonged-release, once~     daily tacrolimus formulation, on long-term graft survival in kidney and liver allograft~     recipients. This study will also evaluate the overall long-term impact of Advagraf on kidney~     and liver allograft recipients.~   "
115361|NCT02057471|"~     20 Patients will be recruited with confirmed colorectal adenocarcinoma and anemia who are~     planned to undergo surgery. All patients will be treated with a single dose of 1g intravenous~     ferric carboxymaltose (FERINJECT).~      It is hypothesized that intravenous iron supplementation is efficacious at raising~     haemoglobin levels and reduced blood transfusion requirements.~   "
115362|NCT02057458|"~     Cystic fibrosis (CF) has many health consequences. A reduction in the ability to perform~     exercise in patients with CF is related to greater death rates, steeper decline in lung~     function, and more frequent lung infections. However, the physiological mechanisms for this~     reduced exercise capacity are unknown. The investigators laboratory recently published the~     first evidence of systemic vascular dysfunction in patients with CF. Therefore, it is~     reasonable to suspect that the blood vessels are involved with exercise intolerance in CF.~     This study will look at how 1) blood flow and 2) artery function contribute to exercise~     capacity in CF.~   "
115363|NCT02057445|"~     The administration of allogeneic third party derived LMP specific-CTLs (special peripheral~     blood cells from another person) that are made specific to fight EBV infection) in Children,~     Adolescents and Young Adults (CAYA) with EBV-associated refractory or relapsed lymphoma will~     be feasible ( able to be done), safe and well tolerated (no unexpected serious events will~     occur). In addition, potential donors who are EBV positive will be enrolled to donate~     peripheral blood to help build a bank of these specific EBV fighting cell lines.~   "
115364|NCT02057432|"~     This research study is a pilot study designed to evaluate magnetic resonance imaging-guided~     therapy (MRT) as a possible treatment for breast cancer. In this pilot study, the~     investigators are studying if it is possible to use intra-operative MRI to guide surgery. The~     therapy takes place in the Advanced Multimodality Image Guided Operating (AMIGO) suite at~     Brigham and Women's Hospital.~      The purpose of this study is to investigate if it is possible to perform the breast~     conserving surgery with the help of intra-operative magnetic resonance imaging in the~     advanced multimodality image guided operating suite. It is hoped that intra operative MRI may~     improve the surgeon's ability to know the exact margins of tumor. Currently, approximately~     40% of women need to come back to the operating room and have the margins of the cancer~     re-excised.~   "
115365|NCT02057419|"~     The purpose of this study is to answer the following questions: (a) how do sexual and~     reproductive health (SRH) delivery method characteristics play a role in user preference for~     specific SRH methods; (b) can we understand the interplay between salient SRH product~     characteristics and effective use; (c) does effective use differ by indication (e.g., whether~     the product is for contraception or lubrication); and (d) can this knowledge help product~     developers better understand how to design new SRH products and develop behavioral (or~     point-of-care) interventions to optimize use?~   "
115366|NCT02057406|"~     Omega 3 supplements will improve depressive symptoms to a greater extent than placebo in~     heart failure patients with moderate to severe major depressive disorder.~   "
115367|NCT02057393|"~     The initial treatment for most people with melanoma involves wide excision of the skin and~     sentinel node biopsy. As with other cancers, the status of the sentinel node provides~     important prognostic information to the patient and physician. Sentinel node biopsy was first~     developed using only a blue dye. Technetium99, a radioactive protein, was added later and~     provides the ability to image the patient and identify relevant lymph node basins. For the~     last 15 years or so, the standard method of SLN localization includes both tech99 and blue~     dye. While the rates of localization overall are excellent, these methods each have~     drawbacks. We are investigating a new method of finding sentinel nodes that uses a green dye~     that has an infrared signal. Our hypothesis is that indocyanine green (ICG) and real time~     lymphangiography is equivalent to technetium99 and methylene blue in identifying sentinel~     nodes (SLN) in patients with melanoma.~   "
115368|NCT02057380|"~     The purpose of this study is to provide access to continued treatment for subjects who~     participated in other Astellas sponsored trials and for whom the investigator feels the~     subject may benefit from continued treatment.~   "
115369|NCT02057367|"~     Anterior scalp block with 0.5% plain Marcaine 20 ml. may reduce the intraoperative opioid~     consumption in neurosurgical patients who undergoing the supratentorial craniotomy compared~     to those who receive 0.9% normal saline solution (placebo).~   "
115380|NCT02057224|"~     Renal denervation has recently shown to improve glucose metabolism and insulin sensitivity in~     addition to reducing blood pressure. The mechanisms are however unclear. The investigators~     hypothesize that renal denervation alters adipose tissue function by reduced sympathetic~     outflow, measured by fat biopsies and markers of inflammation and insulin sensitivity. 15~     clinical patients undergoing renal denervation are recruited to the study investigating~     anthropometry, peripheral blood samples, body composition, heart rate variability and~     subcutaneous fat biopsies at baseline and 6 months after renal denervation.~   "
116810|NCT02038556|"~     The purpose of this pilot study is to evaluate our RN CBT-I program outcomes and determine~     utility of this program as a high-value care model targeted specifically to our sleep center~     patient population.~      Hypothesis: PIRS will improve from baseline to 2 month follow up~   "
115370|NCT02057354|"~     The investigators are examining the effects of exercise and cardiovascular fitness on~     cognitive processes, brain function, and the amount of several proteins in the blood. These~     proteins include a hormone called cortisol, also known as the stress hormone, and a growth~     factor called brain-derived neurotrophic factor (BDNF). The stress hormone cortisol is~     produced by the adrenal glands. Stress, exercise, obesity, and other factors may influence~     cortisol levels. BDNF is a protein that promotes the health of nerve cells in the brain and~     in the body. It plays a role in the growth, maturation, and maintenance of these cells. The~     amount of this protein in blood samples is therefore an indicator of healthy nerve cell~     function. Here, the investigators are investigating if exercise improves brain function by~     changing BDNF levels. Participation in this research study will take approximately 4 months.~     During this time, participants will make four initial study visits. The first visit is for~     informed consent and screening, the second and third visits are for baseline fitness testing,~     and the fourth visit is for a blood draw, cognitive testing, and a functional Magnetic~     Resonance Imaging (fMRI) exam. Functional MRI is a brain imaging technique that uses a~     magnetic field to take pictures of the brain while a person performs a given task. It will~     take up to approximately three weeks to complete these initial four study visits. Following~     the four initial study visits, the exercise-training program will begin. Participants will be~     randomized to one of two training programs: an aerobic exercise program and a non-aerobic~     exercise program consisting of strengthening, balance and stretching exercises. The exercise~     training program will last 12 weeks. There will be three one-hour exercise sessions per week.~     After completion of the exercise-training program, participants will attend three follow-up~     study visits. The first two follow-up visits are for fitness testing. The third and final~     follow-up visit is for a blood draw, cognitive testing, and an MRI exam.~   "
115371|NCT02057341|"~     This is a Phase 2 pilot study, involving a 48-week treatment period, designed to test the~     effectiveness of investigational study drug ARRY-371797 in treating patients with symptomatic~     genetic dilated cardiomyopathy due to a lamin A/C gene mutation, and to further evaluate the~     drug's safety. Approximately 12 patients from the US will be enrolled in this study.~   "
115372|NCT02057328|"~     Τhe effectiveness of newer angiotensin-II receptor blockers and cardioselective~     beta-adrenergic blockers in treatment of arterial hypertension and in improvement of arterial~     stiffness has been established in previous studies among the hypertensive population. The~     present study is a comparison of the performance of two drugs, telmisartan and nebivolol, in~     24h ambulatory blood pressure values and in the degree of arterial stiffness of patients with~     stage I arterial hypertension.~      Measurements will be carried out with the use of 24-h ambulatory blood pressure measurement~     devices and the method of pulse-wave velocity analysis. The effects of telmisartan and~     nebivolol are going to be compared for a total time period of 12 months.~      The aim of this project is to determine whether the expected decrease in arterial stiffness~     of subjects with stage I arterial hypertension can be attributed to the blood pressure fall~     solely, or to other factors as well. These factors are possibly dependent on the action of~     these drugs on the renin-angiotensin II-aldosterone system (RAAS) or on peripheral~     vasodilatory actions.~      The present study is going to be the first comparative test of the anti-hypertensive effects~     of the two pharmaceutical substances in 12 months' time, and of the elimination of total~     cardiovascular risk in terms of primary prevention of cardiovascular attacks.~   "
115373|NCT02057315|"~     This is a Phase 1/ Phase 2, 12-week, multi-center, randomized, double-blind, cross-over,~     placebo-controlled study to evaluate the efficacy and safety of ELS-M11 compared to placebo~     in 50 male and female subjects, aged 18 to 65 years that suffer recurring moderate-severe~     migraine headaches (2-8 per month).~      This study is designed to describe the efficacy and safety of ELS-M11 as compared to placebo.~   "
115374|NCT02057302|"~     Dyslipidemia contributes greatly to the formation and progression of atherosclerosis (AS),~     which plays a dominant role in leading to CHD.~      Xuezhikang is a partially purified extract of fermented red yeast rice (Monascus purpureus).~     It is composed of 13 kinds of natural statins, unsaturated fatty acids, ergosterol,amino~     acids, flavonoids, alkaloid, trace element, and so forth. Xuezhikang has been recommended in~     a guideline for China adult dyslipidemia prevention.~      This study aims to evaluate the benefit and side effect of Xuezhikang, a potential~     alternative drug of statins, for patients with dyslipidemia, and thus provide further~     evidence for clinical application.~   "
115375|NCT02057289|"~     The purpose of this research study is to examine the pharmacokinetics (the process by which a~     drug is absorbed, distributed, metabolized, and eliminated by the body) of micafungin when it~     is given at 5mg/kg dose to immunocompromised children as anti-fungal prophylaxis. These~     children are at high risk for developing invasive fungal disease due to their compromised~     immunity and associated variable degree and duration of neutropenia. Currently, children who~     receive micafungin are given daily or alternate day dosing. The investigators will give a ONE~     TIME dose of micafungin and draw PK levels up to 96 hours post-infusion. The investigators~     goal is to obtain comparable micafungin drug concentrations at the end of 96 hours (4 days)~     as compared to lower dose at every 24 hour dosing. The investigators dosing proposal is~     likely to be effective prophylaxis for immunocompromised patients and would broaden its~     applicability to larger populations.~   "
115376|NCT02057276|"~     The purpose of this study is to determine whether Repetitive Transcranial Magnetic~     Stimulation (rTMS) can augment occupational therapy in improving motor function in children~     (10 years of age or older) and young adults (< 21 years of age) with chronic hemiparesis from~     either stroke or cerebral palsy.~   "
115377|NCT02057263|"~     Vaccines are one of our most effective public health tools but many who need them don't~     respond well and are not protected. Adjuvants boost immune responses and are commonly~     included in vaccine preparations. Bisphosphonates are the most commonly prescribed treatment~     for osteoporosis and may represent a new class of adjuvant. Bisphosphonates are well~     tolerated with chronic administration and have very few adverse effects. Research suggests~     that these medications can stimulate the immune system.~      Bisphosphonates are of special interest in populations with impaired immunity and an~     inability to amount protective antibody responses following immunizations. We propose a pilot~     study to evaluate the clinical relevance of this finding in humans. We will study the effect~     of bisphosphonates on quantitative humoral immune response to hepatitis B vaccine in healthy~     older volunteers who have not previously received this vaccine.~   "
115378|NCT02057250|"~     Primary Objective:~      To collect real-use data of the sarilumab auto-injector device (AID) used by rheumatoid~     arthritis (RA) participants.~      Secondary Objective:~      To compare the pharmacokinetic (PK) exposure of sarilumab administered by AID versus~     prefilled syringes (PFS).~   "
115379|NCT02057237|"~     1. The primary objective of this study is to assess the feasibility of treating patients~          with metastatic castration resistant prostate cancer with mitotane. Secondary objectives~          are to assess safety and tolerability as well as response rate of therapy~        2. To assess the toxicity of Mitotane in men with HRPC~        3. To assess the relationship between baseline serum adrenal androgens and their response~          to Mitotane~   "
115381|NCT02057211|"~     This project aims to evaluate the efficacy of autologous mesenchymal stem cell treatment to~     preserve insulin production and beta-cell mass in recently diagnosed patients with type 1~     diabetes mellitus. The hypothesis to be tested is that an increased number of circulating~     mesenchymal stem cells will provide immune modulatory properties, and thereby stop the immune~     process in islets causing progressive beta-cell death.~   "
115382|NCT02057198|"~     The overall aim is to characterize and to compare the extent and quantity of C. difficile~     stool shedding, perianal colonization and environmental contamination in patients who~     received oral fidaxomicin, oral metronidazole, or oral vancomycin. This is a prospective,~     randomized, microbiologic and molecular, study of environmental contamination from patients~     with proven C. difficile associated diarrhea (CDAD).~   "
115383|NCT02057185|"~     Diseases do not only have a physical role in people's live, but they usually involve changes~     in life as whole. They may modify the structure of the conjunction with life setting, thus,~     deeply impacting relationships with others. While clinical results of new therapies for~     hematological diseases are well documented in scientific literature in terms of prolonged~     life expectancy or remission from disease, less is known about problems and barriers~     preventing the return of patients with a chronic blood ailment to everyday life.~      Indeed, there are no published data on this topic within the Italian context. The present~     explorative study aims at identifying the main problems with which patients affected by a~     Chronic Hematological Disease (CHD) deal when returning to everyday working life, factors~     associated with work reintegration and, finally, to understand the need for facilitators~     enhancing reintegration outcomes.~      Results from this study will be also helpful to raise consciousness about the problem of~     reintegration into the labour market of workers with CHD and to call for awareness campaigns~     for the general public and health professionals.~   "
115384|NCT02057172|"~     The purpose of this study is to determine the optimal dose or doses of HM11260C, when~     administered once a week under the skin, to improve the control of blood sugar levels in~     patients with early-stage type 2 diabetes mellitus (T2DM).~   "
115385|NCT02057159|"~     Multi-center, randomized , double-blind, placebo-controlled , two arm parallel design study~     of NeuroVax™ vs. Incomplete Freund's Adjuvant ( I F A) placebo. 200 subjects with Secondary~     Progressive SPMS~   "
115386|NCT02057146|"~     Single operater pancreatico-cholangioscopy is performed through the working channel of~     conventional duodenoscopes. A visual evaluation of the biliary and pancreatic ductal systems~     is completed and obvious or suspicious macroscopic lesions are targeted by biopsy forceps.~      Evaluation of the usefulness of probe based confocal laser endomicroscopy in the evaluation~     of suspected premalignant lesions in the biliary duct and in the pancreas.~   "
115387|NCT02057133|"~     This study evaluates the safety of abemaciclib in combination therapies (letrozole,~     anastrozole, tamoxifen, exemestane, exemestane plus everolimus, trastuzumab, LY3023414 plus~     fulvestrant, pertuzumab plus trastuzumab with loperamide) for breast cancer that has spread~     to other parts of the body.~   "
115388|NCT02057120|"~     The objective of the project is to investigate the influence of application of Kinesio Taping~     in young athletes in football, muscle strength and muscle activation in the performance of~     the Single Leg Hop Test tests and Triple Hop Test methods: will be conducted a randomized,~     placebo-controlled and double-blind. 24 individuals will be athletes who fit the criteria for~     inclusion will be randomized into 2 groups (Placebo, Kinesio Taping Taping) and will be~     submitted to the tests of Single Leg Hop Test, Triple Hop Test, the isokinetic evaluation and~     electromyographic of Rectus Femoris dominant lower limb. Then the intervention shall be~     carried out with application of Kinesio Taping for activation of rectus femoris muscle group~     and placebo intervention Kinesio Taping with application of Kinesio Taping of transverse way~     the rectus femoris without tension in the Placebo group Taping. The volunteers will be~     re-evaluated 30 minutes after application of the technique and 12:0 am after with the same~     tests for that later can be compared the results obtained in each group. Analysis: will be~     achieved statistical tests and adopted a significance level of 5 percent~   "
115389|NCT02057107|"~     Compare the overall survival of patients with the addition of docetaxel to the overall~     survival of patients treated with SBRT and cetuximab alone. In addition, we will determine~     the difference in progression free survival (PFS), the rate of local recurrence (LR) and of~     distant metastases (DM) across the SBRT and cetuximab + docetaxel arm and the arm receiving~     SBRT and cetuximab alone. To better resolve the impact of the experimental treatment on PFS,~     LR, and DM, patients will be stratified by the presence/absence of prior cetuximab treatment~     and then randomized to either the control arm (cetuximab and SBRT only) or the experimental~     arm (cetuximab, SBRT, and docetaxel).~   "
115390|NCT02057094|"~     The purpose of this study is to evaluate the physiological consequences of extreme military~     training and determine whether protein supplementation enhances recovery by promoting gains~     in lean body mass. This study will be conducted at the US Marine Survive, Evade, Resist,~     Escape (SERE) school at Camp Lejeune, North Carolina.~      SERE school may be an ideal setting to assess nutritional interventions that promote recovery~     from severe military operational stress, and identify innate or experiential variables that~     may lead to increased levels of resilience in Warfighters. Our laboratory has recently~     demonstrated the detrimental effects and stressful nature of SERE. Heart rates and~     stress-related hormones increased dramatically, with concomitant reductions in circulating~     anabolic hormones. Additionally, SERE causes significant weight loss (15-20 lbs), which~     probably included lean body mass. The effects of severe operational stress induced by SERE,~     particularly the loss of lean mass, may degrade physical performance, increase injury risk,~     and compromise military readiness. Under controlled laboratory conditions, consuming high~     protein diets or supplemental high-quality protein promotes muscle protein retention,~     enhances muscle protein synthesis, and protects lean body mass in response to stress. Whether~     consuming supplemental protein promotes lean mass recovery and physiological resilience~     following a 'real-world' military stress has not been determined. Further, the level of~     supplemental protein necessary to optimize recovery from extreme military operational stress~     has not been elucidated.~      Up to 90 US Marines will be enrolled in a 46-day double-blind, placebo-controlled trial.~     Using complex body composition measurements, kinetic modeling of human metabolism, blood~     sampling and cognitive and nutrition questionnaires, the consequences of SERE and the~     efficacy of protein recovery nutrition on lean mass accretion and Warfighter resilience will~     be assessed.~      We hypothesize that consuming a specially formulated, high-quality supplemental protein~     ration item will speed recovery of lean body mass, physiological, and psychological~     resilience following extreme military operational stress.~   "
115402|NCT02056938|"~     The primary objective of the following randomized open label trial is to demonstrate how low~     immunological risk patients (no anti HLA immunization and first kidney transplantation) but~     diagnosed at high-risk of delayed graft function (assessed by DGFS score) could benefit from~     induction with ATG for preventing delayed graft function compared to Basiliximab.~   "
132587|NCT01831856|"~     The purpose of this study is to assess the efficacy of F373280 on the maintenance of normal~     cardiac rhythm after direct electric cardioversion in patients with persistent atrial~     fibrillation and cardiac failure.~   "
115391|NCT02057081|"~     This project addresses the rehabilitation and mental health needs of married combat Veterans~     post-deployed from Iraq or Afghanistan with a mild traumatic brain injury (mTBI) by providing~     psychoeducation, communication and problem solving skills in a multifamily group (MFG)~     setting. In this group, Veterans and spouses/cohabiting partners learn customized therapeutic~     strategies to help compensate for mTBI deficits and promote Veteran community integration,~     interpersonal and emotion regulation skills, and marital satisfaction. The effectiveness of~     the skills-based MFG will be compared to that of a health education group which offers a~     supportive environment and basic education without skills training through a randomized~     clinical trial. As there is currently no family-based intervention for Operation Enduring~     Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans with mTBI offered within the VA spectrum~     of services, this intervention fills a crucial gap in healthcare for our newest Veterans.~   "
115392|NCT02057068|"~     This study addresses the neglected topic of sleep disturbance in older caregiving dyads-a~     topic that has important implications for the safety, health, functioning and quality of life~     of older Veterans living at home and being cared for by a family caregiver (CG). The purpose~     of the study was to develop and field test non-pharmacological, technology enhanced sleep~     hygiene, exercise and meditation interventions to improve sleep in Veteran caregiving~     dyads.The conceptual framework of the intervention incorporated components of cognitive~     behavioral therapy, psycho-education and self-management support for individuals with chronic~     conditions with an emphasis on cultivating competence and mastery.~   "
115393|NCT02057055|"~     Recent research in the investigator's lab has shown that bacteria are present not only on the~     outer surface of our skin, but also in the deeper components as well. In this study, the~     investigator will study the bacteria present in different components of the skin including~     the epidermis, dermis, subcutaneous fat, and hair follicle, and determine if and how these~     bacteria change after repeated use of different commercially available hand soaps. It is~     expected that the bacteria populations in the different skin components will change with the~     use of different soaps.~   "
115394|NCT02057042|"~     The investigators will conduct a randomized clinical trial of Peer-Supported cCBT versus~     enhanced usual care (EUC) for 330 patients with new episodes of depression in primary care at~     three VA sites and their associated Community-Based Outpatient Clinics (CBOCs).~   "
115395|NCT02057029|"~     Investigators will examine the impact of the Breast Cancer Index (BCI) result on patients'~     anxiety / fear of recurrence and satisfaction with decisions regarding endocrine therapy.~   "
115396|NCT02057016|"~     The primary objective of this study is to evaluate sustained clinical remission (for the~     definition see below) in patients with inflammatory bowel disease receiving long-term (> 2~     years) scheduled treatment with infliximab.~      Secondary objectives include:~        -  to identify predictors of sustained clinical remission during long-term infliximab~          scheduled treatment~        -  to identify predictors of loose of response during infliximab scheduled maintenance~          treatment~        -  to identify predictors for maintaining clinical remission in patients who discontinue~          infliximab because of long-lasting steroid-free clinical remission~        -  to evaluate percentage of surgery during and after treatment (total follow-up)~        -  to evaluate safety of long-term infliximab scheduled treatment~      List the clinical hypotheses~      Infliximab is indicated and recommended in moderate to severe inflammatory bowel disease~     patients who not tolerate or are not responsive to conventional therapies. Most of randomized~     clinical trials about the use of infliximab in inflammatory bowel diseases are limited to 52~     weeks and very few data come from some observational studies about results of prolonged (over~     one year) treatment with infliximab. No validated predictors of sustained clinical remission~     or loss of response are available so far. Moreover, few data are available about the~     hypothetical reduction of IBD related surgery in the biological era.~      In this proposal we suggest the following hypotheses:~        -  infliximab scheduled treatment may be efficacious in maintain long-term clinical~          remission;~        -  among clinical, laboratory and endoscopic data some predictors of sustained clinical~          remission during infliximab long-term scheduled treatment may be found;~        -  among clinical, laboratory and endoscopic data some predictors of loss of response~          during infliximab long-term scheduled treatment may be found;~        -  among clinical, laboratory and endoscopic data some predictors of sustained clinical~          remission after infliximab discontinuation because of long-lasting (> 6 months)~          steroid-free clinical remission may be found;~        -  maintenance of remission with infliximab may reduce rates of surgery over time;~        -  long-term scheduled treatment with infliximab may be safe and well tolerated. Results~          from this study may really help clinicians to make practical decisions in these~          particular clinical settings.~   "
115397|NCT02057003|"~     The purpose of this study is to evaluate the efficacy and tolerability of DAA-based regimens~     in the clinical practice in HIV/HCV-coinfected patients.~      Hypothesis: The efficacy and tolerability of DAA-based regimens in the clinical practice is~     different to what is observed in clinical trials in HIV/HCV-coinfected patients.~   "
115398|NCT02056990|"~     Athletes have to participate in screenings in order to reduce injuries. Up-to-now most~     screenings are purely clinically based. Literature, however, indicates the importance of~     knowledge on deviant movement patterns as possible risk factors for injuries. From this~     perspective, the current project aims to measure movement patterns, gait and running in young~     athletes to optimise training and prevent injuries.~      2D- and 3d registration methods, force plate data and pressure plate data will be used to~     document the performance of the athletes.~   "
115399|NCT02056977|"~     The purpose of this study is to:~        -  Compare PEEP level selected by individualized PEEP titration by electrical impedance~          tomography and PEEP level routinely used in post-operative cardiac patients with~          Hypoxemic Respiratory Failure;~        -  Evaluate the agreement between the results of a rapid titration (total procedure~          duration = 5 min) versus an already validated slow titration (total procedure duration =~          40 min) of the same patient, sequentially. Specifically, degree of collapse and degree~          of distention in each PEEP level, estimated by EIT;~        -  Compare hemodynamics during the two maneuvers of PEEP titration;~        -  Evaluate the efficacy of the selected PEEP (minimum PEEP preventing lung collapse less~          than 5%) to maintain stable levels of the following variables: arterial oxygenation,~          respiratory system compliance, and degree of collapse by EIT;~        -  Compare these results (evolution of the three variables, along 4 hours) with the control~          strategy (default strategy currently used in the institution) group.~   "
115400|NCT02056964|"~     The purpose of this study is to determine the effectiveness of the HEART Pathway, a clinical~     decision aid for the care of patients with chest pain, in a real-world clinical setting.~     This will be accomplished through the building of a transformative collaboration between~     research, education, and health systems operations to more effectively and efficiently~     provide patient care.~   "
115401|NCT02056951|"~     The primary aim of the study is to analyse the long-term effectiveness of an~     interprofessional and interdisciplinary rehabilitation program named PASTOR, with a~     biopsychosocial approach for participants with chronic non-specific low back pain (CLBP)~     compared to the standard inpatient multidisciplinary orthopaedic rehabilitation (MOR) in~     Germany. The investigators hypothesize that in adults with CLBP the rehabilitation program~     PASTOR would result in a significantly higher increase in functional ability 12 months after~     completion of the program in comparison to the standard inpatient MOR. The investigators~     further hypothesize that PASTOR would lead to significantly larger improvements regarding~     pain-related cognitions, pain coping strategies, physical activity, health-related quality of~     life, and back pain episodes compared to the standard inpatient MOR.~   "
115403|NCT02056925|"~     · 2D Speckle Tracking echocardiography gained importance for the evaluation of ventricle~     contractility. Many indications have been developed in child population. However, the~     comparability of measurements between different software systems is not well defined. We~     choose to compare two software systems very often used in paediatric subjects : Echopac by~     General Electric and QLAB 9.0 by Philips. We offer a randomly second echocardiography to~     children which have normal heart. We compare Strain and Strain rate results between the two~     tests with a study of variability : ultrasound variability, operator variability, reader~     variability.~   "
115404|NCT02056912|"~     Human lipodystrophies (lipoD) represent a heterogeneous group of diseases characterized by~     generalized or partial fat loss, with fat hypertrophy in other depots when partial.3, 4~     Insulin resistance, dyslipidemia and diabetes are generally associated, leading to early~     complications. Acquired lipoD can be generalized, resembling congenital forms, or partial, as~     the Barraquer-Simons syndrome, with loss of fat in the upper part of the body contrasting~     with accumulation in the lower part. The most common forms of lipoD are iatrogenic. In human~     immunodeficiency virus-infected patients, some first-generation antiretroviral drugs were~     strongly related with peripheral lipoatrophy and metabolic alterations. Genetic forms are~     very uncommon: recessive generalized congenital lipoD result in most cases from mutations in~     the genes encoding seipin or the 1-acyl-glycerol-3-phosphate-acyltransferase 2 (AGPAT2).~     Dominant partial familial lipoD result from mutations in genes encoding the nuclear protein~     lamin A/C or the adipose transcription factor PPARgamma. Importantly, LMNA mutations are also~     responsible for metabolic laminopathies, resembling the metabolic syndrome and progeria, a~     syndrome of premature aging. Molecular genetic bases of many rare forms of genetic lipoD~     remain to be elucidated.~   "
115405|NCT02056899|"~     This is a pilot study to evaluate the tolerability and effects of maintenance gabapentin~     therapy on the rate of premature birth in women who have had preterm labor.~   "
115406|NCT02056886|"~     Breast carcinoma requires frequently an adjuvant therapy after surgical excision: in this~     way, one of the major criteria indicating the need of adjuvant chemotherapy is the diagnosis~     of a metastatic lymph-node invasion, mainly in the axillary field. Axillary surgery is~     therefore mandatory at the diagnosis of breast carcinoma. For many years, in order to avoid~     unnecessary complications due to extensive axillary surgery (for instance, arm enlargement by~     lymphedema), a limited surgery is frequently performed on the first supposed invaded~     lymph-nodes (LN) called sentinel LN technique; if the sentinel LN are not invaded,~     extensive axillary surgery can be omitted. To decide it during the surgery, removed sentinel~     LN are cut in 3 to 4 slices which are examined immediately as smears (cytology) or frozen~     slices (pathology). However, due to hazard in cutting the LN, micro-metastases can be~     misdiagnosed. That is why a recent molecular biology method has been developed in which the~     total LN are crushed and blended, then analyzed by OSNA technique (One Step Nuclear Acid~     analysis) so as to amplify and detect the mRNA coding for cytokeratin-19 protein witnessing~     the LN metastatic invasion. A standardized automated technique is available with a mean time~     of 30 to 50 minutes according to the number of analyzed LN.~      In 12 international studies (2830 cases) the consistency between OSNA technique and final~     pathology is of 91 to 98% and the sensitivity seems higher. Less than 5% of all breast~     carcinomas cells don't express CK-19 protein.~      The use of OSNA technique requires a dedicated machine and a skilled pathologist, increasing~     slightly the operation time; however it allows to avoid the immediate and long-term~     complications due to the radical LN axillary surgery in case of negativity of the sentinel LN~     procedure. To date, the three techniques including extemporaneous examinations (OSNA or~     classical methods) or not (classical pathological analysis) have their own advantages and~     drawbacks.~      SAGE study main objective is to compare these three techniques in terms of direct costs and~     Quality of Life impacts. The superiority of any of these three techniques is not the purpose~     of SAGE study, but the economic burden of OSNA technique in comparison with the 2 others in~     the standard setting in France.~      Quality of Life and Pain evaluations will be performed immediately after surgery and during~     the 6 months after.~   "
115407|NCT02056873|"~     The purpose of this study is to evaluate the effectiveness and safety of deep brain~     stimulation (DBS) as a possible new treatment for Tourette Syndrome (TS).~      This investigation will (1) test the hypothesis that centromedian (CM) continuous brain~     stimulation will be an effective, safe method for the treatment of tics in medication~     refractory TS, (2) will define the intra-operative and post-operative physiological changes,~     and (3) will test the hypothesis that responsive brain stimulation (RBS) will provide an~     alternative to chronic DBS in TS.~   "
115408|NCT02056860|"~     The purpose of this study is to test a lung air vibrator device for vibrating air inside the~     lung. This exploratory diagnostic trial will test a novel and non-invasive means of detecting~     lower airway infections using exhaled breath sample.~   "
115409|NCT02056847|"~     Primary Objective~      : To evaluate that there is no different effect on HbA1c between routine lipid lowering~     therapy(Livalo 2mg) and intensive lipid lowering therapy(Livalo 4mg) in the hyperlipidemic~     patients with impaired fasting glucose (IFG).~      H0: µT-µC ≥ 0.4 vs H1: µT-µC < 0.4~      µT = the change of HbA1c in the test drug (Pitavastatin 4 MG) µC = the change of HbA1c in the~     control drug (Pitavastatin 2 MG)~   "
115410|NCT02056834|"~     The primary objective of this study is to observe the safety, the radiological and clinical~     outcomes of chronOS Inject after having been used as bone void filler in internal fixation of~     proximal tibial fractures.~   "
115411|NCT02056821|"~     This study investigates if there are hemodynamic alterations in acute stroke that predispose~     patients to impaired perfusion and regulation of cerebral blood flow. To test this, we will~     target recruitment of acute ischemic stroke patients who present to the ED within 12 hours of~     symptoms onset. Enrolled subjects will receive continuous noninvasive hemodynamic monitoring~     contemporaneous with measurements of cerebral blood flow velocities and cerebral oximetry.~   "
115412|NCT02056808|"~     The purpose of this study is to determine whether increasing doses of SMT C1100 are safe,~     well tolerated and achieve appropriate blood levels in patients with Duchenne Muscular~     Dystrophy (DMD).~   "
115440|NCT02056444|"~     Bleeding during and after total hip replacement surgery is a primary concern to the surgical~     and anaesthetic team. Tranexamic acid is a commonly-used drug that helps blood clotting and~     decreases surgical bleeding. The investigators commonly administer the drug intravenously~     prior to the procedure. Some patients are unable to receive the drug in this form, because of~     risks related to blood clotting. The investigators know, from studies in total knee~     replacement surgery, that the investigators can deliver tranexamic acid directly to the~     surgical site (topically), with similar benefits and less of the drug absorbed into the~     bloodstream, resulting in less risk to the patient. The investigators seek to find if similar~     benefit in terms of reducing blood loss is seen using topical tranexamic acid in hip~     replacement surgery. The investigators' hypothesis is that the topical form will be~     equivalent, but not better than the intravenous form for reducing intra- and postoperative~     bleeding. The investigators also expect to see decreased levels of tranexamic acid in the~     bloodstream when it is administered topically.~   "
115413|NCT02056795|"~     Introduction: Ankle sprains, the most common sports-related musculoskeletal injury, account~     for approximately 25% of sports injuries. An estimated 40% of these individuals will progress~     to develop chronic functional ankle instability (CFAI), which can significantly affect~     athletic performance and activities of daily life. Stresses from the injury can damage the~     ligaments, muscles, nerves and mechanoreceptors. It is widely accepted that ankle~     proprioception is critical for balance and that individuals with CFAI demonstrate decreased~     proprioception and altered muscular function, which impairs postural stability. The goal of~     this study is to determine if a single application of electroacupuncture can have an~     immediate positive outcome related to balance in individuals with CFAI.~      Methods: This single blinded randomized trial will include 12 subjects receiving a single~     application of electroacupuncture and 12 subjects in the placebo group receiving sham~     electroacupuncture. Subjects aged 18-50 with a history of unilateral inversion ankle~     sprain(s) and chronic symptoms of instability will be selected. Balance will be assessed pre-~     and post-treatment using force plate data during a single-leg stance and via the Star~     Excursion Balance Test (SEBT). GB-34 and GB-40 will be used for the experimental group and~     non-traditional points on the medial aspect of the leg will be used for the sham~     electroacupuncture group. Both will be connected to the electrical stimulation unit for 10~     minutes. Results from this study may inform future research investigating the ability of EA~     at decreasing the risk of ankle sprains, improving perceived stability, and reducing the risk~     of subsequent degenerative changes.~   "
115414|NCT02056782|"~     A Pilot Study of ODSH in Acute Myeloid Leukemia~   "
115415|NCT02056769|"~     Patients with brain hemorrhage resulting from a ruptured aneurysm (SAH) are at risk of~     developing a condition called vasospasm, one or two weeks after their hemorrhage. This is a~     major cause of stroke and death following SAH. A special type of CT scan, called CT~     perfusion, analyzes regional blood flow in the brain. We hypothesize that CT perfusion scans~     performed on admission and day 6 post-hemorrhage will enable us to predict which patients~     will go on to develop vasospasm.~   "
115416|NCT02056756|"~     Open-label phase Ib/II, multicenter, international non-comparative trial. This study is~     designed to determine the safety and efficacy of the novel salvage regimen (CBd) followed by~     a carfilzomib maintenance in patients with relapsed or refractory multiple myeloma.~      Patients will be evaluated at scheduled visits in up to 4 study periods:~      pretreatment, treatment, maintenance and long-term follow-up (LTFU).~   "
115417|NCT02056743|"~     The purpose of this study is to evaluate the possibility of drug interactions before and~     after taking red ginseng or fermented-red ginseng by estimating metabolic rate of indicator~     drugs for cytochrome P450 and P-glycoprotein.~   "
115418|NCT02056730|"~     The dialysis patient of chronic kidney disease and parathyroid hormone levels greater than or~     equal to 800 Pg per ml were divided into two groups by randomized 1:1, one group to receive~     medication and a control group that did not receive the medication. By group to receive in~     those taking 25 mg per day to get the default dose and the dose is adjusted according to the~     levels of calcium and parathyroid hormone. By adjusting the dose of 25 mg every 3 weeks for a~     period of 12 weeks, the drug is between 25-75 mg dose , with a maximum dose of not more than~     100 mg per day (weeks 3, 6 , 9).~      After a follow-up treatment in weeks 12, 24 and 36 with an blood,ultrasound test parathyroid~     glands , abdominal x-ray side . To evaluate the changes without the drug .Unless the track~     during treatment the patients with low blood calcium levels over 8.4 mg per dL . No dose~     adjustment . regpara while if blood calcium levels less than 7.5 mg per deciliter . Must be~     stop taking medication for patients in the control group will receive standard treatment .~     Which consisted of dose vitamin D sterol and parathyroid surgery . Unable to control the~     level of parathyroid hormone with vitamin D sterol.~      While participating in the research are not allowed to adjust the amount of vitamin D sterol~     in the two groups . But the amount of dialysate calcium phosphate binders and can be adjusted~     as appropriate to healthcare is fine .~   "
115419|NCT02056717|"~     The primary purpose of this study is to investigate the effects of dexamethasone on~     inflammatory reactions after uterine artery embolization. The secondary purpose of this study~     it to investigate the effects of dexamethasone on postembolization syndrome (severe pain,~     nasea and vomiting).~   "
115420|NCT02056704|"~     The reason the investigators are doing this study is to compare the results of angiography~     versus angiography with intravascular ultrasound in dialysis grafts/fistulas that are~     blocked.~   "
115421|NCT02056691|"~     This pilot study looks to explore the biological effects of exercise on cancer and muscle~     cells using a two week exercise program (HIThigh intensity training) on 20 patients with~     newly diagnosed and operable colorectal cancer following diagnosis and prior to surgery.~     Maximal oxygen uptake will also be measured. The aim of this pilot is to assess the~     feasibility of recruiting participants to and carrying out a two week preoperative exercise~     program in patients with colorectal cancer.~   "
115422|NCT02056678|"~     The objective of this study is to determine if IV acetaminophen administered intraoperatively~     can decrease the dose of narcotics required for adequate pain control and shorten recovery~     time in the PACU specifically in obese patients at risk for obstructive sleep apnea.~   "
115423|NCT02056665|"~     RANDOMIZED CLINICAL TRIAL, PLACEBO COMPARED TO EVALUATE THE EFFICACY AND SAFETY OF~     MINOCYCLINE IN ANGELMAN SYNDROME (A-MANECE STUDY)~   "
115450|NCT02056314|"~     This study will compare a computerized tutorial to a brochure in terms of their education~     impact of people who wish to end voluntary self-exclusion. Voluntary self-exclusion is a~     program used by people who seek to bar themselves from further access to the casino or other~     gambling venue. The Centre for Addiction and Mental Health (CAMH), in cooperation with~     Ontario Lottery and Gaming (OLG), is developing a tutorial designed to provide practical~     information to players who choose to reinstate and return to gambling. The goal of this study~     is to determine if this new computerized tutorial decreases the harm of gambling experienced~     by gamblers who are reinstated. For example, are they less likely to relapsing to problematic~     levels of gambling.~   "
115451|NCT02056301|"~     The aim of this study is to compare the efficacy of epidural and IV analgesia in controlling~     pain in patients undergoing Nuss repair of pectus excavatum. The primary end point will be~     the difference in pain scores at rest and with activity (coughing, deep breathing and~     movement) during postoperative days 1 -5.~   "
115424|NCT02056652|"~     Preterm birth (PTB) is associated with over one million infant deaths annually worldwide. The~     incidence of PTB in the United States is 11.5% with more than 500,000 deliveries occurring at~     less than 37 weeks gestation annually. The rate of PTB in the United States increased to~     12.8% in 2006, and remains high compared to almost all other developed countries, despite the~     introduction of many public health and medical interventions designed to delay PTB. Weekly~     treatment with 17-alpha hydroxyprogesterone caproate beginning at 16-20 weeks gestation has~     been shown to significantly reduce the risk of PTB and is currently recommended for women who~     experienced spontaneous PTB in a prior pregnancy. However, a strategy for the prevention of~     spontaneous PTBs in which therapeutic intervention is restricted to women with a previous PTB~     is likely to have a small effect on the overall rate of prematurity since only about 10% of~     spontaneous PTBs arise in women with such a history. A major reduction in rates of mortality~     and morbidity in premature babies will only be achieved with increased precision in the~     identification of women at risk of spontaneous PTB and through the development of an~     effective prevention for this complication. Transvaginal ultrasound measurement of cervical~     length is a reliable screening test for prediction of PTB. Although treatment with vaginal~     progesterone is effective in decreasing PTB in women with a short cervix, over 30% of women~     still experience premature delivery and many women find daily administration of progesterone~     to be challenging. Preliminary studies have suggested that use of an intravaginal pessary may~     be effective in preventing PTB. If effective this approach would be particularly appealing~     because of the wide availability of pessaries, ease of use, and low cost. Unfortunately,~     existing studies are inadequate to confirm effectiveness; a well designed, properly powered,~     prospective randomized trial is warranted prior to widespread implementation in clinical~     practice. We propose such a trial to study the effectiveness of the pessary in decreasing the~     incidence of PTB in an inner city Philadelphia population.~   "
115425|NCT02056639|"~     Preterm birth (PTB) is a major health problem and contributes to more than 50% of the overall~     perinatal mortality. Twins are at increased risk for PTB. The number of twins births has~     risen substantially due to the increased use of assisted reproductive technology. The rate of~     twin births in the United States rose from 18.9 to 32.2 per 100 live births between 1980 and~     2004. The increased rate of PTB in twins is associated with increased morbidity and mortality~     rates. Almost one in four very low birth-weight infants (below 1500 g) born in the United~     States are twins, as are one in six infants who die in the first month of life. Cervical~     shortening is a risk factor for PTB. Transvaginal ultrasound measurement of cervical length~     is a reliable screening test for prediction of PTB. There is currently no effective treatment~     to decrease the incidence of PTB in women with twin gestations, but there is some evidence~     that the use of a cervical pessary in women with a short cervix has promise. If effective~     this approach would be particularly appealing because of the wide availability of pessaries,~     ease of use, and low cost. Unfortunately, existing studies are inadequate to confirm~     effectiveness; a well designed, properly powered, prospective randomized trial is warranted~     prior to widespread implementation in clinical practice. We propose such a trial to study the~     effectiveness of the pessary in decreasing the incidence of PTB in an inner city Philadelphia~     population.~   "
115426|NCT02056626|"~     The proposed research is designed to determine if the application of classical conditioning~     operations could influence the clinical effects of a regimen of antihypertensive drug~     therapy. It will be determined if, capitalizing on conditioned pharmacotherapeutic effects,~     patients can be effectively treated with smaller cumulative amounts of drug.~   "
115427|NCT02056613|"~     Background:~      - Pluripotent stem cells are cells that can be converted to any type of cell (muscle, nerve,~     liver, etc.). Researchers are collecting blood samples to develop way to make a special cell~     product called induced pluripotent stem cells (iPSCs). iPSCs may be used to repair or replace~     organs and tissues, produce blood and immune cells for transfusion, or correct inherited~     immune and blood diseases. iPSCs can be made from many kinds samples, such as skin, blood, or~     hair. This is different from embryonic stem cells, which can only be derived from embryos.~      Objectives:~      - To develop new methods to make iPSCs; to identify better ways to collect, produce, and grow~     them; and to make an iPSC bank.~      Eligibility:~      - Healthy adults and adults already in a treatment protocol who have a medical condition that~     could be treated with iPSCs.~      Design:~        -  All participants will be screened with questionnaire, physical exam, and blood and HIV~          tests.~        -  All participants:~        -  Will donate 4 tablespoons of blood. It will be taken by needle from a vein in their arm.~        -  Participants already in another protocol:~        -  Will have their blood collected, separated in a lab, and iPSCs grown in large numbers.~          Some may have their sample given back to them as a treatment.~        -  Samples will be kept in the study up to 5 years or until a participant withdraws from~          the study or becomes ineligible to participate, or the study is closed. If participants~          have not withdrawn their consent, they may be contacted in the future to donate again.~   "
115428|NCT02056600|"~     This study is to evaluate the safety/tolerability and pharmacokinetics of the combinations of~     gemigliptin 50mg and metformin HCl extended release 1000mg in comparison to each component~     administered in healthy male volunteers.~   "
115429|NCT02056587|"~     An estimated 10,000 metastatic renal cell carcinoma (RCC) patients receive first-line therapy~     in the Russian Federation. Bevacizumab (Avastin) in combination with interferon-alpha (IFN)~     is a recommended first-line treatment for metastatic RCC according to clinical~     recommendations of Russian Ministry of Health from 15.07.2010. Two randomized phase III~     trials (AVOREN, CALGB) showed that 50% of patients will progress on bevacizumab plus IFN~     within 8.5 - 10.2 months and will need sequential therapy.~      Everolimus (Afinitor) is a single agent which was evaluated and demonstrated efficacy in~     randomized phase III study (RECORD-1) in metastatic RCC patients after failure of targeted~     therapy. However, in this trial everolimus was compared with placebo for the treatment of~     patients whose disease had progressed on treatment with sunitinib or sorafenib (n=227). Only~     9% (n=24) of patients received bevacizumab. Thus, efficacy data of everolimus in patients~     with disease progression on first-line bevacizumab is limited.~      Evaluating the effectiveness of everolimus in metastatic RCC patients with failure on~     bevacizumab with/without interferon alpha has a scientific and practical sense, and it is~     important for Russian Federation.~   "
115430|NCT02056574|"~     This is a randomized, double-blind, placebo-controlled, single-dose study investigating the~     safety and efficacy of NA-1 in patients with subarachnoid hemorrhage (SAH) undergoing~     endovascular repair of ruptured intracranial aneurysms. Up to 300 male and female patients~     with SAH undergoing endovascular repair of a ruptured intracranial aneurysm will be dosed~     with 2.60 mg/kg of NA-1 or placebo as a 10 minute intravenous infusion after completion of~     the endovascular procedure on Day 1 of the study period. Subjects will undergo interim~     procedures at Day 2-4, Day 30-45, and end-of-study procedures on Day 90.~   "
115452|NCT02056288|"~     This study compares nerve blocks to IV pain medicines in children with broken arms. We are~     trying to see if blocking the nerves in the broken arm results in better pain control and~     less side effects than injections of morphine into a vein after surgery for a broken elbow.~   "
115431|NCT02056561|"~     Introduction and Aim: Desflurane and sevoflurane are frequently used for maintenance of~     anesthesia and studies have shown that these anesthetics cause a variety of changes in~     oxidative stress and antioxidative defense mechanisms. The chemical structure of propofol is~     similar to some free radical consumers such as endogenous vitamin E and butylated hydroxene~     toluene. This study aims to compare the effects of sevoflurane, desflurane and propofol~     infusion anesthesia on the oxidant and antioxidant systems of patients undergoing~     laparoscopic cholecystectomy.~      Material and Method: Forty-five patients, ASA (American Society of Anesthesiologists) I-II,~     score between 18-50 years with planned laparoscopic cholecystectomy under general anesthesia~     were included in the study. Patients were divided into 3 groups as total intravenous~     anesthesia (TIVA) (group T n: 15), sevoflurane (group S n: 15) and desflurane (group D n:~     15). Propofol 2 mg/kg IV, fentanyl 1 mcg/kg IV, vecuronium 0.1 mg/kg IV given to all groups~     for anesthesia induction. For maintenance of anesthesia group S were ventilated with 2%~     sevoflurane, 50% air and 50% O2 mix at 6 L/min flow. Group D were given 6% desflurane 50% air~     and 50% O2 mix at 6 L/min flow. Group T were given propofol infusions of 12 mg/kg/hr for the~     first 10 minutes, 9 mg/kg/hr for the second 10 minutes and 6 mg/kg/hr after that. Patients~     were ventilated with 50% air and 50% O2 mix at 6 L/min flow. Before induction and after the~     operation venous blood samples were taken to evaluate the levels of glutathion peroxidase,~     total oxidants and antioxidants.~   "
115432|NCT02056548|"~     Previous studies dealt with patients who maintained antiviral drugs for 2 ~ 6 months after~     final chemotherapy and they revealed that many of the patients who stopped preemptive~     antiviral drug within 6 months experienced viral reactivation. Based on the study results,~     guidelines recommend that preemptive antiviral therapy should be maintained for at least 6~     months. Nevertheless, many clinicians apply the preemptive antiviral drugs for 1~2 years or~     longer after final chemotherapy without definite evidences, and this practice increases the~     medical expenditure a lot. Therefore, the investigators are going to find out the proper and~     safe duration of preemptive antiviral therapy which can be a good reference in the future~     practice.~   "
115433|NCT02056535|"~     The aims of this study are to: 1) examine the effectiveness of Screening, Brief Intervention~     and Referral to Treatment (SBIRT) among Mexican-origin young adults (age 18-25), using a~     motivational intervention delivered by a Health Promotion Advocate, relative to standard care~     with and without assessment, on a reduction in heavy drinking and alcohol-related problems in~     the emergency department (ED) at the U.S.-Mexico border; and, 2) identify variables that are~     related to effectiveness of the intervention and that predict successful treatment outcome.~     Patients will be re-assessed by telephone at three and twelve months to evaluate outcomes.The~     specific hypotheses to be examined in this proposal are: 1) the motivational interview will~     lead to significantly greater reductions in the maximum number of drinks on an occasion and~     in Rapid Alcohol Problem Screen (RAPS4) score at the 12-month follow-up compared to standard~     care without assessment (those who screen positive but are not assessed) as well as compared~     to standard care with assessment; 2) the motivational interview will lead to significantly~     greater reductions in number of drinking days per week, average number of drinks per day,~     maximum number of drinks on an occasion, RAPS4 score, and number of negative consequences of~     drinking at 3-month and 12-month follow-up compared to standard care with assessment; 3) a~     positive breath alcohol concentration (BAC) at the time of the ED visit and/or self-reported~     drinking prior to the event resulting in the ED visit will be positively predictive of~     effectiveness of the intervention; 4) attributing a causal association of drinking and the~     reason for the ED visit will be positively associated with effectiveness of brief~     intervention; 5) readiness to change (and stage of change) will be positively associated with~     effectiveness of brief intervention; 6) risk taking/impulsivity and sensation seeking~     dispositions will be negatively associated with effectiveness of brief intervention.~   "
115434|NCT02056522|"~     The use of MDS to access the presence of melanoma in the skin.~   "
115435|NCT02056509|"~     Airway management and maintaining adequate ventilation during cardiopulmonary resuscitation~     (CPR) are important. The rule of 30:2 compression-to-ventilation ratios before endotracheal~     intubation and keeping 1 breath every 6-8 seconds with advanced airway are generally accepted~     according to 2010 Advanced Cardiac Life Support (ACLS) guideline. This recommendation~     emphasizes on the timing and frequency of ventilation during CPR. However, poor clinical~     evidence had been established concerning adequate volume, airway flow and pressure in each~     cycle.~      There are increasing evidence that hyperventilation during resuscitation reduces pulmonary~     venous return and, therefore, compromises cardiac output and circulation. Another research~     reported that using high flow oxygen mask alone during basic life support (BLS) results in~     better survival rate and overall outcome compared with conventional positive pressure~     ventilation.~      Our study applies flowmeter to measure ventilation parameters as frequency, duration, exhaled~     volume and airway pressure on intubated patients who received artificial ventilation during~     CPR. The parameters will correlate with information from accelerometry and capnometry~     simultaneously during resuscitation. . Investigators also focus on the influence of chest~     compression, which increases intra-thoracic pressure considerably. This effect may act~     against positive pressure ventilation and probably minimize the efficiency in each~     ventilation or circulation..~      Details about how to ventilate one patient during CPR include right timing, duration,~     adequate volume and coordination are in debate. Unfortunately, current practice based on~     clinical guidelines emphasizes little on this issue. Investigators are committed to refine~     contemporary practices and hopefully improve qualities of resuscitation.~      Investigators proposed the hypothesis that coordinate chest compression and ventilation may~     minimize the increasement of airway pressure and improve the effect of circulation~   "
115436|NCT02056496|"~     Pomegranate phenolics (such as the ellagitannin punicalagin and ellagic acid) are metabolized~     by the human gut microbiota to yield a number of metabolites called urolithins (mainly~     Uro-A). Both ellagic acid (EA) and urolithins can exert a number of biological activities.~     However, the bioavailability of ellagic acid has been reported to be very low and the~     existing studies are controversial so far. The investigators want to carry out a robust~     (cross-over, double-blind) pharmacokinetic assay in 20 healthy volunteers, using two types of~     pomegranate extracts (PEs). PEs with low (PE-1) and high (PE-2) punicalagin:EA ratio will be~     administered. The investigators will analyze blood and urine samples using~     UPLC-ESI-QTOF-MS/MS. The investigators will evaluate:~        -  The pharmacokinetics of EA.~        -  The effect of punicalagin:free EA ratio on the pharmacokinetics of EA and urolithins~          production.~   "
115437|NCT02056483|"~     The purpose of this study is to examine if a psychosocial intervention including a nurse~     navigator and systematic symptom screening may reduce psychological and physical symptoms as~     well as health behavior after breast cancer.~   "
115438|NCT02056470|"~     Assess the safety and functionality of the Freedom Knee® system through a multi-center~     clinical trial. Study endpoints include a comparison of Pre-Surgery versus Post-Surgery data~     for:~        1. Range of Motion~        2. Quality of Life measurements using Knee Society Scale (KSS)~        3. Survivorship as defined by 'No Revision' of baseline implant~        4. Quality of Life measurements using the WOMAC Score~   "
115439|NCT02056457|"~     The purpose of this study is to evaluate the effectiveness of selected healthy marriage (HM)~     and responsible fatherhood (RF) grant programs, authorized by by the Claims Resolution Act of~     2010. The programs are intended to improve the well-being of parents and families in domains~     such as economic self-sufficiency, parenting, and healthy relationships.~   "
115453|NCT02056275|"~     To assess the effect of oral nutritional supplementation with dietary counseling versus~     dietary counseling alone on growth of preschool children over a period of 90 days.~   "
115441|NCT02056431|"~     Painful diabetic peripheral neuropathy (DPN) affects more than 5.5 million people with~     diabetes. People with painful DPN have trouble sleeping, participating in social events, and~     conducting daily activities such as going to the store. Several prescription medications are~     available for the treatment of DPN symptoms, but none work perfectly and all have side~     effects that may be difficult for some patients.~      When patients report their symptoms and side effects to their doctor, they provide the doctor~     with important information to help them make adjustments to treatment that will help with~     symptoms and that the patient can tolerate in terms of side effects. In some cases, doctors~     may encourage patients to make these changes on their own at home based on their experience~     with therapy. However, patients may have a long time between visits to their doctor and may~     have trouble describing their symptoms to their doctor during a brief 10 to 15 minute visit.~      This clinical trial explores the possibility of computerized telephone calls to patients~     (Interactive Voice Response, IVR, technology) to gather information about treatment~     experiences that can then be reported to the doctor or used to guide patients to make changes~     in how they take the medication. It addresses the following question: Can routinely asking~     patients about their experiences with medications and using that information to encourage~     clinically appropriate titration improve patient quality of life?~      The investigators hypothesize that systematic collection and feedback of information about~     DPN treatment preferences and experience from newly treated patients to their primary care~     physician will facilitate treatment changes that improve patient outcomes~   "
115442|NCT02056418|"~     The pathogenesis of Crohn Disease (CD) is unknown, but there is evidence show that the~     inadequate immune response or overreaction of the immune system against food antigens or~     components of the commensal flora involve it. Corticosteroid therapy is effective for adult~     patients with CD, but it has side effects and can't promote mucosal healing. In recent years,~     Enteral nutrition (EN) is becoming primary therapy in induction and maintenance remission of~     CD, especially in children. But the mechanism of EN in induction and maintenance remission of~     CD is still unclear, and parts of patient have good clinical response to EN therapy while~     other don't. So we design the study to explore whether EN treats CD by effecting intestinal~     flora and whether the intestinal flora of patient with CD relates with clinical response.~   "
115443|NCT02056405|"~     Postoperative Ileus is defined as the transient postoperative functional inhibition of~     propulsive bowel activity. The ethiology of this process can best be described as~     multifactorial. In its pathogenesis different mechanisms are involved such as hormones and~     neuropeptides, inflammation, narcotics and the Autonomic nervous system. Is one of the most~     common causes of prolonged hospital stays after abdominal surgery, thereby increasing~     health-care resource utilization. More importantly, it causes patient discomfort in the form~     of nausea, vomiting, and stomach cramps. It has a variable duration but is usually solved in~     3 to 4 days. Prolonged Ileus is associated with postoperative complications like an increase~     on urinary and pulmonary infections, profound venous thrombosis and wound-site complications.~      Mosapride is a prokinetic agent that acts as a selective serotonin agonist (5- HT4) that~     facilitates acetylcholine release from the intrinsic plexus. This accelerates gastric~     emptying and propulsive peristaltic movements on the lower intestines. Mosapride has no~     action over the central nervous system therefore the lesser side effects like cardiac~     arrhythmias and extrapyramidal symptoms. For being a safer drug we chose it to be the center~     of our research.~      Two randomized controlled trials studied Mosapride concluding it shortens PI after colorectal~     surgery. However these trials took place on specific populations (Orientals) with less than~     50 patients and only one of them included laparoscopic treatment specifically. Also the end~     point of these studies didn't consider the impact of PI over hospital stay or costs to the~     health system.~      We therefore decided to conduct a prospective randomized study in patients undergoing~     laparoscopic colorectal surgery for colon cancer. The patients will be randomized to receive~     treatment or placebo after surgery. With this study we intend to prove that patients treated~     with mosapride immediately after surgery suffer from shorter postoperative ileus with earlier~     oral intake and shorter hospital stay.~      The primary aim of the trial is to assess the effectiveness of the use of Mosapride in~     shortening the duration of the Postoperative ileus in patients undergoing colorectal~     laparoscopic surgery. The trial hypothesis is that the standardized use of Mosapride~     immediately after colorectal laparoscopic surgery is safe and accelerates the recovery of~     propulsive bowel activity, thereby shortening postoperative ileus and hospital stay.~   "
115444|NCT02056392|"~     Study to assess the effect of Selumetinib [AZD6244; ARRY-142886] [Hyd-Sulfate]), on QTc~     interval in healthy male volunteers.~   "
115445|NCT02056379|"~     The study aims to analyze and compare the clinical effects of using inhaled budesonide or~     intravenous dexamethasone in the treatment of postextubation stridor on children admitted to~     the pediatric intensive care units at Hospital Municipal do M´Boi Mirim and Hospital Albert~     Einstein.~   "
115446|NCT02056366|"~     The purpose of this study is to see if it is safe and effective to give alpha lipoic acid in~     people with cardiac autonomic neuropathy(CAN). Cardiac autonomic neuropathy(CAN) affects the~     nerves that control heart rate and blood flow to the heart in people with diabetes. CAN may~     cause problems with the rhythm of the heartbeat or decrease blood flow to the heart.~   "
115447|NCT02056353|"~     Most critically ill patients are confronted with hyperglycaemia, which is associated with an~     increased mortality and morbidity risk. Normalising these elevated blood glucose levels by~     intensive insulin therapy may improve patient outcome, but is associated with an increased~     risk of hypoglycaemia. The LOGIC-2 study hypothesises that the LOGIC-Insulin computerised~     software algorithm will allow better (less hyperglycaemia) and safer (less hypoglycaemia)~     blood glucose control in critically ill patients than nurse-directed blood glucose control.~   "
115448|NCT02056340|"~     Influenza (the 'flu') is a common virus infecting approximately 5-20% of the population in~     the United States and causing as many as 500,000 deaths worldwide each year. Currently, there~     are only a few treatments for influenza infection and none of these target inflammation that~     can be caused by the virus. This study will test whether the anti-inflammatory effects of~     statins, a class of drugs most often used to treat high cholesterol, will decrease the~     severity of illness in patients who are infected with influenza by testing markers of~     inflammation in the blood and recording resolution of influenza illness.~   "
115449|NCT02056327|"~     Oral appliances are an accepted means to treat obstructive sleep apnea. We propose to develop~     monitoring sensors that could be inserted into commercially available oral appliances in~     order to monitor effectiveness of the oral appliances in treating sleep apnea.~   "
115454|NCT02056262|"~     The primary objective of this study is to estimate the distribution of pathogenic species and~     genotypes of bacterial diversity in 7 stages ICDAS (International Caries Detection and~     Assessment System) corresponding to the severity of dental caries among patients aged 3-45~     years consulting in the Dentistry Departments of the Nîmes University Hospital and the~     Montpellier University Hospital.~   "
117422|NCT02030548|"~     The aim of the study is to evaluate surgery-related bleeding and mortality in patients~     needing acute coronary artery bypass grafting with or without valve replacement during dual~     antiplatelet therapy with aspirin and a P2Y12 receptor blocker (Clopidogrel, Prasugrel,~     Ticagrelor)~   "
115455|NCT02056249|"~     The aim of this study is to use Positron Emission Tomography (PET) imaging to measure changes~     in norepinephrine transporter (NET) concentrations in the brain and periphery of healthy~     individuals during hypoglycemia.~      We hypothesize that during hypoglycemia, NE levels will increase within the brain, especially~     the hypothalamus, and this likely contributes to activation of glucose counterregulatory~     responses. We further hypothesize that during hypoglycemia, NET concentrations in key~     glucoregulatory regions will change in order to sustain or prolong sympathetic nervous system~     activation of counterregulatory responses.~   "
115456|NCT02056236|"~     The purpose of this study is to estimate the effect of medical treatment of~     electro-encephalographic status epilepticus on neurological outcome of patients with~     postanoxic encephalopathy after cardiac arrest.~   "
115457|NCT02056223|"~     Current pharmacological options to treat an hemodynamically significant PDA (HsPDA) in~     preterm infants are limited to non-selective cyclo-oxygenase (COX) inhibitors, indomethacin~     or ibuprofen. Recently paracetamol exposure has been reported to successful closure of PDA.~     Aim of this randomized double-blind controlled study is to compare the efficacy and the~     safety of standard PDA treatment ibuprofen versus paracetamol-experimental treatment . We~     hypothesize that paracetamol is more effective than ibuprofen in closing PDA, perhaps~     ameliorating the safety profile of the pharmacological treatment.~   "
115458|NCT02056210|"~     The objective of this study is to assess whether there are differences in the mobilization of~     CD34+ cells and EPC in response to Mozobil in patients with diabetes mellitus compared to~     subjects without diabetes. Currently, there are no non-invasive methods for the study of bone~     marrow function in humans. This project aims to evaluate in patients with type 1 or type 2~     diabetes mellitus the ability to mobilize CD34+ cells and EPC from the bone marrow to the~     periphery in response to the exogenous mobilizing agent AMD3100 / plerixafor (Mozobil),~     compared with a group of non-diabetic individuals. While it has been recently shown that~     diabetic patients do not respond to mobilization induced by G-CSF (Filgrastim), the~     investigators herein hypothesize that diabetic patients can adequately respond to~     mobilization induced by Plerixafor~   "
115459|NCT02056197|"~     Motor control exercises have demonstrated a good option for recovery from chronic low back~     pain. The purpose of this study is investigated the effectiveness of an exercise program for~     trunk stabilization performed in stable and unstable surfaces for people with nonspecific~     chronic low back pain (NCLBP). Patients will be randomly divided into 3 groups; control group~     will receive placebo treatment with shortwave; stable group will receive an exercise protocol~     to stabilize the trunk on a stable surface and unstable group will receive the same exercise~     protocol but performed on an unstable surface.~      We hypothesized the unstable group will present pain reduction and functional improvement.~   "
115460|NCT02056184|"~     The purpose of this study is to determine whether therapy modifications (including addition~     of ultrasound-guided treatment change) can change imaging results in patients with early~     rheumatoid arthritis in a stable clinical disease activity state.~   "
115461|NCT02056171|"~     This study is designed to assess the safety and efficacy of quetiapine as treatment for~     pediatric delirium.~   "
115462|NCT02056158|"~     In HIV+ cigarette smokers, with no prior history of pulmonary infections, emphysema is often~     developed at an earlier age and is a significant cause of morbidity despite treatment with~     antiretroviral drugs. Preliminary data gathered from HIV+ individuals that smoke cigarettes~     strongly support the hypothesis that the combination of HIV infection and smoking creates~     increased stress in the lower respiratory tract. To examine the underlying factors that~     contribute to the accelerated development of emphysema in this cohort, samples from the lower~     respiratory tract will be provided by HIV+ and HIV- subjects. The samples collected will~     serve as biomarkers for assessing the onset of emphysema.~   "
115463|NCT02056145|"~     Evaluation of the combination of lateral femoral cutaneous nerve single shot and femoral~     nerve single shot block as effective and safe alternative postoperative analgesic technique~     after hip replacement surgery.~   "
115464|NCT02056132|"~     There is an urgent need for a noninvasive method to diagnose bronchial infections and~     exacerbations in patients with Cystic Fibrosis (CF). The current method to diagnosed~     infections involves either collecting a sputum sample or obtaining a bronchoalveolar lavage~     (BAL). However, some patients cannot produce sputum. At the same time the decision of when a~     patient has an exacerbation continues to be very subjective. In this exploratory study, we~     propose a new, noninvasive method to diagnose bronchial infections and to evaluate possible~     markers of inflammation that can assist in a noninvasive way in the determination of~     exacerbations.~   "
115465|NCT02056119|"~     Aerosol delivery during mechanical ventilation has long been a long debated topic. As~     evidence- based knowledge about the delivery of aerosol to the lungs of mechanically~     ventilated patients increases, one piece of the puzzle has remained unexplored; measurement~     of clinically relevant outcomes. The primary aim of this research is to compare clinical~     outcomes (ventilator- associated events (VAEs), length of stay (LOS) in intensive care unit~     (ICU) and total days on mechanical ventilation) when using a traditional jet nebulizer versus~     a newer generation vibrating mesh nebulizer during mechanical ventilation. The secondary aim~     of this research is to identify source of bacteria by obtaining cultures of each nebulizer~     and ventilator circuit and plating them for colony growth and identification.~   "
115466|NCT02056106|"~     This study compares two models for implementing antidepressant treatment in 10 HIV clinics in~     Uganda. Using a cluster randomization, 5 clinics implement a task-shifting, protocolized~     model, and 5 others rely on clinical acumen. The protocolized model includes (1) routine~     depression screening at each clinic visit for all adult patients by trained expert patients~     at triage, (2) training nurses to diagnose depression and prescribe and monitor~     antidepressant treatment using an algorithm-based protocol, and (3) monthly supervision and~     monitoring by hired study psychiatrists. The clinical acumen model also includes routine~     depression screening and ongoing supervision, but it relies on the clinical acumen of trained~     primary care providers to further evaluate and treat patients who show signs of depression at~     screening, as opposed to a structured protocol. The primary aim is to test the hypothesis~     that the nurse-driven protocolized model will result in greater uptake of antidepressant~     treatment and better quality of depression care outcomes. The study will also test the~     hypotheses that treatment of depression results in improved HIV treatment adherence, work~     functioning and consistent condom use.~   "
115467|NCT02056093|"~     In spontaneously breathing mechanically ventilated patients, the adequacy between the~     patient's demand and the level of respiratory support delivered by the ventilator is a major~     clinical issue. Neurally adjusted ventilator assist (NAVA) and proportional assist~     ventilation (PAV) have been developed to adapt the level of assistance to the patient's~     demand. These two modes have been compared to pressure support ventilation (PSV) but have not~     been compared to each other.~   "
115468|NCT02056080|"~     A retrospective, observational, not EPA, multicenter study to evaluate the Clinical Benefit~     of Trastuzumab in Combination With Lapatinib in Metastatic Breast Cancer HER2 Positive~     Patients Who Has Been Previously Treated With Trastuzumab and/or Lapatinib between January~     2005 and December 2011~   "
115469|NCT02056067|"~     The investigators propose to examine 121 postmenopausal women diagnosed with hormone-receptor~     positive breast cancer who have been taking aromatase inhibitors (AI) for at least 6 months~     and are experiencing at least mild arthralgia originating during AI treatment, the yearlong~     effect of exercise vs. attention control (health education), and on toxic side effects of AI.~   "
115470|NCT02056054|"~     The purpose of this study is to provide insights into the cause, development and effects of~     de novo autoimmune hepatitis so that prevention and treatment strategies can be developed in~     order to reduce post-liver transplant morbidity, the frequency of liver allograft loss and~     the need for re-transplantation.~   "
115471|NCT02056041|"~     Selection criteria for safe hepatectomy for HCC are not well established. The aim of this~     study was the validation of the selection criteria for safe hepatectomy for hepatocellular~     carcinoma.~   "
115472|NCT02056028|"~     The definition of biliary fistula is heterogeneous and the more accepted is that proposed by~     the ISGLS. We devised a precise definition of post-resectional biliary fistula and a~     well-established policy both for its disclosure and management.Aim was the validation of our~     definition, and management of biliary fistula after hepatic resection in a large prospective~     cohort of patients and its comparison with that of the International Study Group of Liver~     Surgery (ISGLS).~   "
115473|NCT02056015|"~     This study is a first-in-human (FIH), single-dose, open-label, phase 1 study designed to~     assess the safety, pharmacokinetics (PK), distribution, and radiation dosimetry of~     [68Ga]MLN6907 after a single intravenous (IV) administration. Patients with Metastatic~     Colorectal Carcinoma who are scheduled for resection of liver metastases as part of their~     treatment plan will be eligible for enrollment.~   "
115474|NCT02056002|"~     Fragmentation of care can lead to poor treatment adherence in patients with chronic medical~     conditions which can, in turn, lead to adverse health consequences, poor quality of life, and~     patient dissatisfaction. Poor treatment adherence may be due to lack of sufficient patient~     education, time delays in delivery of care, lack of adequate healthcare coordination, or~     difficulty accessing various healthcare providers across a front desk which serves as a~     healthcare bottle-neck. Better efficiency in healthcare delivery, with greater connectivity~     through knowledgeable and trained peer volunteers and inexpensive cell-phones integrated by a~     smart telephone exchange may alleviate some of the care and communication burden faced by the~     healthcare system. Specifically, such community health education volunteers (peer-buddies)~     who are experienced in managing their disease condition may be able to impart knowledge and~     confidence to a recently diagnosed patient in a much more personalized manner than that of a~     group therapy session. An additional important advantage is the peer-buddy's ability to~     relate to the patient in a manner consistent with their social, ethnic, and cultural believes~     without language barriers or differences that may stem from socioeconomic strata. We will use~     sleep apnea as an example condition to test the effect of a peer-buddy helper (combined with~     the universal availability of personal cell phones) on the problem of poor care coordination~     and treatment adherence to the CPAP treatment for sleep apnea. Sleep apnea is a very common~     condition that affects 7-12% of the US population, and if left untreated, can lead to poor~     health and even death through its effects on high blood pressure, heart disease, stroke, and~     motor vehicle accidents. Fortunately, CPAP therapy can lead to a 3-fold reduction in such~     consequences, but patient adherence to such CPAP treatment is generally poor. We have~     recently completed a small study that demonstrated improved usage of CPAP treatment by~     patients receiving help from a peer-buddy with excellent results. We propose to further~     enhance the peer-buddy community-volunteer concept in our proposed research by combining~     this with cell-phone technology and a telephone exchange that improves access to healthcare~     providers, technicians, and home care companies. We hope to show that active community~     participation by experienced lay individuals assisted by the universal availability of~     cheap cell-phones can improve the reach and effectiveness of our healthcare system in~     improving the health and well-being of our patients. If successful, such an innovative and~     community-based approach can be applied to other chronic medical conditions.~      Hypothesis #1: We hypothesize that patients in the peer-driven intervention with interactive~     voice response (PDI-IVR) group will experience a greater patient satisfaction (measured by~     Likert scale64,70 and PACIC71,72) and perception of care coordination (measured by CPCQ72,73)~     than patients in the usual care (control) group.~      Hypothesis #2: We hypothesize that patients in the PDI-IVR group will experience a greater~     CPAP adherence (measured by device download), patient activation (PAM), and self-efficacy~     (SEMSA) than patients in the usual care (control) group.~      Hypothesis #3: We hypothesize that patients in the PDI-IVR group will experience greater~     improvements in HR-QOL (measured by FOSQ) vigilance (psychomotor vigilance testing) and blood~     pressure than patients in the usual care (control) group.~   "
115475|NCT02055989|"~     This study is a phase I/II dose escalation trial designed to test the feasibility of~     delivering IMRT to thyroid, larynx and hypopharynx cancer patients, and to assess the safety~     and possible improvement in outcome when the dose is increased.~      This protocol is in fact two studies running in parallel: thyroid cancer patients and larynx/~     hypopharynx cancer patients. These two groups of patients are being treated differently and~     will be analysed separately.~      The primary objective of this Phase I sequential cohort study was to determine the~     feasibility of delivering modest acceleration and dose-escalated IMRT in locally advanced~     high-risk thyroid cancers. We report the incidence and prevalence of acute toxicities of 2~     dose fractionation regimens.~      DL1: primary site 58.8 Gy in 28 daily fractions and nodal levels 50 Gy in 28 daily fractions~      DL2: primary 66.6 Gy in 30 daily fractions and post operative nodal levels 60 Gy in 30 daily~     fractions and elective nodal levels 54 Gy in 30 daily fractions~   "
115476|NCT02055976|"~     The purpose of this study is to evaluate the low density lipoprotein cholesterol (LDL-C)~     lowering effect of Bococizumab (PF-04950615;RN316) administered subcutaneously at every two~     weeks (Q14D) in hypercholesterolemic Japanese subjects whose LDL-C is not controlled by a~     stable dose of atorvastatin, or who are naïve to a treatment by lipid lowering drug and whose~     LDL-C is not controlled.~   "
115477|NCT02055963|"~     The goal of this clinical research study is to learn if Minocin® (minocycline) can reduce~     certain side effects of surgery in patients with head and neck cancer (such as pain, fatigue,~     and disturbed sleep). In this study, minocycline will be compared to a placebo.~      A placebo is not a drug. It looks like the study drug, but it is not designed to treat any~     disease or illness. It is designed to be compared with a study drug to learn if the study~     drug has any real effect.~   "
115478|NCT02055950|"~     Trends in organ donor pool are characterized by an increasing age and a shift towards~     cerebrovascular diseases as primary causes of death. As a result, donors older than 60 years~     nowadays represent more than one fourth of the entire donor pool in Italy. This, along with~     an increasing number of patients on the waiting list for transplantation, prompted a growing~     use of organs from subjects older than 60 years that would have been considered unsuitable~     years ago. To improve graft outcomes, transplant of two older kidneys in the same recipient~     has been proposed. To optimize allocation of these organs to single or dual transplantation,a~     scoring system for kidneys, based on biopsy, with scores ranging from a minimum of 0~     (indicating the absence of renal lesions) to a maximum of 12 (indicating the presence of~     marked changes in the renal parenchyma) has been suggested. According to this panel, kidneys~     with a score of 4 or lower are predicted to contain enough viable nephrons to be used as~     single transplants, those with a score of 5, 6, or 7 can be used as dual transplants, kidneys~     with a score greater than 7 are discarded. The survival of kidney grafts obtained from donors~     older than 60 years and allocated for single or dual transplantation on the basis of biopsy~     findings before transplantation was similar to that of single grafts from younger donors. To~     further improve these results, set-up of strategies to preserve organs is crucial to save the~     residual nephron mass and optimize outcomes of these marginal grafts. In this regard, over~     the past 30 years two methods of kidney preservation have been developed. With cold storage,~     the kidney is flushed once it is removed from the donor and placed in an ice-cooled container~     with preservation solution. With the use of pulsatile machine perfusion, the kidney is~     connected to a machine, which pumps a cold solution containing oxygen and nutrients through~     the kidney. This process allows for metabolism to continue in the kidney with end products~     being removed. The broad aim of the present study is to evaluate whether pulsatile machine~     perfusion of kidneys from older/marginal donors may provide better outcomes than static~     perfusion. To this purpose the outcome of recipients of perfused kidneys will be compared~     with the outcome of historical controls receiving non-perfused kidney selected and allocated~     on the basis of the same criteria and matched by gender, age and kidney histologic score.~   "
115479|NCT02055937|"~     The purpose of this study is to study the impact of the immediate implant breast~     reconstruction for patients with mastectomy and postoperative chest wall radiotherapy~   "
115496|NCT02055703|"~     This study will be a single-center, open-label, drug-drug interaction study in healthy male~     and female subjects. The study will consist of 3 parts: A, B, and C. In Part A, the effect of~     itraconazole or rifampin on the pharmacokinetics (PK) of E2609 and metabolites will be~     assessed. Approximately 32 subjects will be assigned to 1 of 2 treatment groups (itraconazole~     or rifampin) in equal numbers, with approximately 16 subjects per group. In Part B, the~     effects of steady-state dosing of E2609 on the PK of digoxin will be assessed in~     approximately 18 subjects. In Part C, the effects of donepezil administered in combination~     with, or 2 hours after, E2609 dosing on the PK of E2609 and metabolites, will be assessed in~     approximately 24 subjects.~   "
115480|NCT02055924|"~     This is an open label, multicenter, dose escalation, phase Ib study to determine the~     recommended dose by assessing the maximum tolerated dose (MTD), safety and efficacy of~     ibrutinib in combination with R-DHAP (Group A/Abis) or R-DHAOx (Group B/Bbis) for patients~     with B-cell malignancies. This dose escalation will be followed by an exploratory expansion~     phase in 3 groups of 12 patients each (Group A/Abis, Group B/B bis and Group C).~      During Part 1 Dose Escalation, the 3+3 design will be applied. Three doses of ibrutinib~     (280, 420 and 560 mg) will be examined sequentially in each cohort by the Dose Escalation~     Committee. Dose escalation will begin at dose level 1 = 420 mg.~      The dose escalation will be performed for two types of associations in five separate groups :~        -  Group A : ibrutinib D1-D21+ R-DHAP~        -  Group B : ibrutinib D1-D21 R-DHAOx~        -  Group Abis : ibrutinib D5-D18+ R-DHAP~        -  Group Bbis : ibrutinib D5-D18 R-DHAOx~      This dose escalation will be followed by an exploratory expansion phase in the group Bbis~     plus a new group including only mantle cell lymphoma (MCL) in first line patients: group C.~     Patients included in the Group C will receive ibrutinib in combination with R-DHAP or R-DHAOx~     according to the choice of the local investigator at time of inclusion of each patient.~   "
115481|NCT02055911|"~     To evaluate the safety of intravitreal ranibizumab repeated injections in patients with~     diabetic macular edema regarding maintenance of retinal ganglion cell function.~   "
115482|NCT02055898|"~     Chronic fatigue syndrome (CFS), characterised by chronic disabling fatigue, sleep impairment~     and other symptoms, is associated with neither a currently identifiable disease process nor~     major psychiatric illness, and has an estimated prevalence in primary care of 1-2%. Sleep~     impairment is common in nearly everyone with CFS, with both daytime sleepiness and~     unrefreshing nighttime sleep reported, and consequent impact on daytime function. It may be~     that fundamental regulatory processes that control sleep are disturbed in CFS, leading to~     different effects on sleep and daytime symptoms depending on the subject's prior sleep,~     daytime routine, medication and other factors. The investigators contacts with patient groups~     have indicated that patients are generally confident that on days when their sleep is better~     they perform better in the day. There is growing evidence that deep, slow wave sleep (SWS) is~     altered in CFS, and this may suggest impairment of build up of sleep pressure during the day.~      The investigators wish to investigate whether enhancement of SWS, which is seen after a drug~     called sodium oxybate, reduces the impact of sleep disruption in CFS on daytime function,~     specifically sleepiness and mental performance. This is a safe and well-tolerated drug that~     is licensed for excessive daytime sleepiness (EDS) and cataplexy associated with narcolepsy.~      The investigators will study 12 patients diagnosed with CFS using international diagnostic~     guidelines. The investigators will record overnight sleep with EEG (brainwave) measurement on~     the 1st and 4th nights of a 4 night period during which sodium oxybate and placebo will be~     taken nightly, and the investigators will measure next-day sleepiness, mental performance and~     fatigue, and compare drug and placebo nights.~   "
115483|NCT02055885|"~     In the literature, the effects of acute oxygen administration on exercise tolerance and~     related symptoms have often appeared to be contradictory. Some investigations have reported~     benefits from acute oxygen supply during exertion, including increased exercise performance,~     reduced dyspnea, and better cardiorespiratory adaptations, whereas other studies have~     reported no improvement. Recently, we advanced then the hypothesis that some patients would~     be non-responders and even worsen under oxygen treatment. The preliminary results confirmed~     our hypothesis since we demonstrated that while 56% of the patients were improved with~     supplemental oxygen, 16% were non-responders and 28% were negative-responders (decreased~     performance and increased dyspnea during endurance exercise with supplemental oxygen).~     However, this was a pilot study offering preliminary insights and tentative conclusions that~     must be confirmed in a larger case series.~      The aims of this retrospective study was :~        1. To confirm on cohorte and with clinical test (the 6-minute walking test - 6WT) the~          deleterious responses to acute oxygen supplementation in LTOT (long terme oxygenotherapy~          treatment) and non-LTOT patients who exhibit exercise desaturation.~        2. To identify the predictive factors among the clinical data (i.e., anthropometric,~          spirometric and gazometric data) and/or functional data recorded during rehabilitation~          program~   "
115484|NCT02055872|"~     Critically ill patients usually require intravenous fluids to correct low blood pressure and~     improve blood flow to vital organs. However, once the patient's blood pressure has improved,~     these fluids can leak out into various organs, including the lung, kidneys, and skin. Excess~     fluid in these tissues, called edema, has been associated with longer ICU stays and higher~     mortality. Thus removing excess fluid is an important goal. The simplest way to treat edema~     is to use diuretics, such as furosemide, which increase urine output.~      To further improve urine output, patients are sometimes given albumin, a protein which helps~     to suck fluid out from the tissues, and keep it in the blood vessel, where it can be filtered~     in the kidney and removed in the urine. Although albumin is often used for this purpose,~     there is little evidence to support it. A large randomized controlled trial is needed to~     determine if albumin plus furosemide is truly more effective than furosemide alone in~     critically ill patients with low levels of blood albumin. We will perform a pilot study to~     assess the feasibility of such a trial.~   "
115485|NCT02055859|"~     Most vestibular schwannomas are benign and slow-growing. Based on that fact, conservative~     management with serial imaging is a viable alternative. For patients who undergo treatment~     because of tumor growth, progressive symptoms, or personal preference, options include serial~     observation, microsurgical resection, fractionated stereotactic radiotherapy, and~     stereotactic single-session radiosurgery.~      Despite improved radiosurgical techniques and lower marginal doses, a recent report has shown~     a somewhat disappointing 10-year actuarial hearing preservation rate of 44.5%, with hearing~     loss developing as much as 6 years after.~      Fractionation of the prescribed dose may takes some advantages from radiobiologic principles~     to reduce toxicity and maintain tumor control.~      Staged frame-based radiotherapy using a 12-hour interfraction interval was successfully used~     at Stanford university and has shown a hearing preservation rate of 77% at 2 years of~     follow-up.~      The aim of the present protocol is to evaluate the hearing preservation, the local control~     and toxicity after single-session (sSRS) or multi-session (3 fractions) radiosurgery (mSRS)~     by using the frameless robotic CyberKnife® system (Accuray Incorporated, Sunnyvale, CA, USA).~      In order to investigate about this a randomised controlled double harm (sSRS vs mSRS) trial~     was designed.~   "
115486|NCT02055846|"~     Prostate cancer (PC) represents one of the most common cancers in industrialized countries.~     Patients with localized disease may be treated with surgery or radiation, while androgen~     ablation is used as first-line therapy in patients with metastatic disease. While most~     patients initially respond well to this hormonal therapy, they most ultimately become~     unresponsive and recur within 2 years as androgen-independent prostate cancer (AIPC).~     Recently, docetaxel-based regimens have demonstrated improved survival in men with AIPC in~     two different, large, phase III studies. However, the median overall survival was prolonged~     for only 2 or 3 months. Androgen independent (AI) progression involves variable combinations~     of clonal selection, adaptive up-regulation of anti-apoptotic genes, ligand-independent~     androgen receptor (AR) activation, alternative growth factor pathways, and immune system~     escape. Additional therapeutic strategies targeting molecular mechanisms mediating~     resistance, combined with immunotherapy must be developed. One strategy to improve therapies~     in advanced PC involves targeting genes that are activated by androgen withdrawal, either to~     delay or prevent the emergence of the resistant AI phenotype. Recently, a~     scientist,identified Heat Shock Protein (Hsp27) as a highly over-expressed gene in AIPC.~     Hsp27 knockdown using antisens oligonucleotides (ASO) and small interfering RNA (siRNA)~     increased apoptotic rates and enhanced hormone- and chemo-therapy in PC. She developed and~     patented a 2nd generation ASO targeting Hsp27 that has been licensed (investigational drug~     called OGX-427) and clinical trials phase I/II is currently in process in PC. Despite OGX-427~     efficiency, the functional role of stress induced Hsp27 in castration or chemotherapy-induced~     apoptosis remains undefined. The purpose of this study is to elucidate the pathways leading~     to Hsp27 action in androgen-independent prostate cancer in order to 1/ Increase the~     pharmacological safety of OGX-427 and 2/find new specific therapeutic targets and treatment~     strategy for androgen-independent prostate cancer .~   "
115487|NCT02055833|"~     In head-neck cancer patients undergoing radiotherapy (RT) malnutrition is associated with~     impaired quality of life, reduced survival, more frequent treatment interruptions and dose~     reductions. The international guidelines recommend early nutritional support in the presence~     of nutritional risk, as it allows preventing or treating malnutrition and improving the~     clinical outcomes, as well as the tolerability of oncologic treatments. Previous nutritional~     intervention trials in head-neck cancer patients have been conducted on small samples and did~     not clarify the role of oral nutritional supplements (ONS). Accordingly, although current~     guidelines recommend as grade A the use of ONS associated with dietary counseling for~     head-neck cancer patients undergoing RT, the efficacy of this nutritional intervention still~     needs to be evaluated in adequately sized and randomized clinical trials.~   "
115488|NCT02055820|"~     This is a multicenter, open-label, dose-finding study of venetoclax administered orally in~     combination with rituximab (R) or obinutuzumab (G) and standard doses of cyclophosphamide,~     doxorubicin, vincristine and oral prednisone (CHOP) in participants with Non-Hodgkin's~     Lymphoma (NHL). The study will consist of 2 stages: a dose-finding Phase Ib stage and a Phase~     II expansion stage. In the Phase I portion of the study, participants will be randomized to~     one of 2 treatment arms venetoclax in combination with R-CHOP (Arm A) and venetoclax in~     combination with G-CHOP (Arm B) and will explore the doses of venetoclax in combination with~     R-CHOP and G-CHOP. The maximum tolerated dose (MTD) of venetoclax in combination with R-CHOP~     and G-CHOP will be determined during the dose-finding stage. For the Phase II portion of the~     study, the venetoclax dose for venetoclax + R-CHOP is on a non-continuous dosing schedule as~     determined by the Phase Ib portion of the study based on safety and tolerability observed in~     participants treated in the dose escalation portion of the study.~   "
115489|NCT02055807|"~     The use of positive end-expiratory pressure (PEEP) and recruitment maneuvers during~     laparotomy will limit the development of atelectasis and therefore improve the aeration~     score.~   "
115490|NCT02055794|"~     The goal of this research is to investigate three different methods of perineal skin closure~     during second-degree perineal wound repair and determine which method is associated with the~     least amount of patient pain.~      Null hypothesis: There will be no difference in patient pain among the three different~     methods for second degree perineal wound repair.~   "
115491|NCT02055781|"~     The primary hypothesis of the study is that treatment with either once-daily or twice-daily~     pacritinib results in a greater proportion of patients with thrombocytopenia and~     myelofibrosis achieving ≥ 35% reduction in spleen volume from baseline to Week 24 than~     treatment with Best Available Therapy, and a greater proportion of patients achieving a ≥ 50%~     reduction in total symptom score from baseline to Week 24 as measured by the~     Myeloproliferative Neoplasm Symptom Assessment Form 2.0.~   "
115492|NCT02055755|"~     The goal of this project to begin using a wound research database with clinical decision~     support features at Winthrop University Hospital. A research database is an electronic~     computer system that is used to collect patient information. Clinical decision support is the~     ability for a computer system to provide medical assistance to the doctor through alerts and~     recommendations based on the information entered. The investigators believe that use of a~     wound clinical decision support tool, much like a drug, will improve healing in patients~     diagnosed with Diabetic Foot Ulcers and ultimately lower the risk of death and illness caused~     by these wounds. In order to develop a useful clinical decision support tool, investigators~     first need to develop a large research database to determine the data points important for~     wound healing. The investigators will be using the data collected in this study for future~     research and publication. Data will be reviewed to answer questions important to diabetic~     foot ulcer healing and for the purpose of developing the clinical decision support alert~     system.~      After providing informed consent, participants will be asked a series of questions related to~     their past medical history, and relevant wound data will be collected. Study staff will~     photograph the wound at baseline, and once per week until the wound is completely healed, or~     for a duration of six months.~      Participants will be expected to return to Winthrop University Hospital for wound follow-up~     on a regular basis, or as determined by the Principal Investigator.~   "
115493|NCT02055742|"~     To evaluate the illumigene Chlamydia and illumigene Gonorrhea assays, using the illumipro-10,~     with male urine, female urine, physician-collected (medical professional) endocervical swabs~     and self-collected vaginal swabs taken from symptomatic and asymptomatic patient populations.~   "
115494|NCT02055729|"~     The main objective of this study is to characterize the evolution (over a period of 28 days)~     of superficial and deep bacterial skin flora in patients with stage 3 or 4 sacral pressure~     ulcers (bedsores). Changes in terms of pathogenic, potentially pathogenic and non-pathogenic~     bacterial species at the intra-individual and population levels.~   "
115495|NCT02055716|"~     To determine the safety and tolerability of multiple doses of Sulforadex® in healthy male~     volunteers over 7 days with qd or bid dosing~   "
117423|NCT02030535|"~     The primary objective of this study is to evaluate the efficacy and safety of orally inhaled~     tiotropium and olodaterol as both a fixed dose combination and a free combination with~     respect to lung function and ECG parameters~   "
115497|NCT02055690|"~     The first part of this study is to find the recommended dosages of a combination of two~     drugs: pazopanib and fosbretabulin, which will be given to female patients with relapsed~     ovarian cancer.~      The second part of the study involves comparing the recommended dose of pazopanib and~     fosbretabulin in combination against pazopanib alone in female patients with relapsed ovarian~     cancer to determine whether the combination is more beneficial that pazopanib on it's own.~   "
115498|NCT02055677|"~     Main goal is to collect and analyze possible differences between ovo / lacto-vegetarians and~     vegans with respect to their personality profiles, values and empathy through validated~     questionnaires. Main hypothesis: vegans and ovo / lacto-vegetarians differ in their~     personality, empathy and values~   "
115499|NCT02055664|"~     This is a prospective, single-centre, randomised, double-blind trial, comparing TAP block~     with continuous infiltration of ropivacaine versus placebo.~      Procedure:~      Once consent has been obtained, patients will be randomised into one of the two groups:~     Ropivacaine or Placebo. At the end of the operation, the TAP block will be implemented via a~     catheter inserted by the anaesthetist.~   "
115500|NCT02055651|"~     Introduction: As employees spent most part of their time at the worksite, it provides a venue~     to address multiple individual risk factors and promote health. The America Heart Association~     (AHA) defined cardiovascular health using as metrics smoking status, body mass index,~     physical activity, diet, total cholesterol, blood pressure and fasting blood glucose.~      Objective: Evaluate Bayer employees' cardiovascular health according to the AHA definition~     and the acceptance to engage in lifestyle change programs.~      Methods: By the time of the annual occupational safety periodic medical examination,~     employees will receive an email with information about the cardiovascular health screening,~     exams requisition (fasting blood glucose and total cholesterol) and a copy of the written~     informed consent. If the employee accepts to participate, after providing a written informed~     consent, he will be evaluated according to the AHA cardiovascular health metrics. Data will~     be collected at the occupational safety electronic health record. After medical evaluation,~     employees will receive a printed feedback with their cardiovascular health score and will be~     referred to indicated lifestyle change programs (healthy weight, smoking cessation, diabetes~     control, high blood pressure control, dyslipidemia control).~      After 12 months we will evaluate the percentage of employees who accept to participate;~     prevalence of the cardiovascular risk factors and distribution according to the AHA~     classification in ideal, intermediate and poor; adherence to lifestyle change programs.~   "
115501|NCT02055638|"~     This study is designed to explore the safety and tolerability, and to compare the activity of~     SRX246 against placebo, in adults with Intermittent Explosive Disorder (IED).~      Adult Male and Female subjects with a current diagnosis of IED will be enrolled. After a~     two-week baseline lead-in phase, study subjects who continue to meet enrollment criteria will~     be randomized to either SRX246 or Placebo treatment groups.~      Study subjects will be examined and asked to answer questionnaires at weekly scheduled visits~     throughout the trial. The study results will be determined based on any changes observed over~     the study period.~   "
115502|NCT02055625|"~     Graft-versus-host disease (GVHD) is a major complication of allogeneic hematopoietic stem~     cell transplantation (HSCT), and is classified as acute (aGVHD) or chronic (cGVHD). aGVHD~     onsets within the first 100 days after transplant or with clinical features including~     erythema, liver dysfunction and oral mucositis, whilst cGVHD or persistent GVHD occurs in~     approximately 30-60% of transplant patients who survive their first year . Long-term~     five-year prognosis for cGVHD patients is poor with a 70% mortality rate. cGVHD manifests as~     an autoimmune-like disease affecting multiple sites, including skin, mouth, eyes,~     gastrointestinal tract, liver, and joints. The oral cavity is the second most common site to~     be affected with symptoms in 45-83% of cases. In the mouth a diverse spectrum of clinical~     features can be found for example mucosal lesions can affect almost any site, salivary gland~     dysfunction and restricted mouth opening. Short-term patients can experience mucosal~     sensitivity, malnutrition, problems speaking, increased caries risk, xerostomia, oral pain~     and a diminished quality-of-life. Long-term complications include secondary malignancies and~     perhaps early death. Clinical management seeks to alleviate the symptoms and improve~     quality-of-life but 50% of patients fail front-line systemic steroid therapy. Oral cGVHD can~     be treated with topical high potency corticosteroids and oral rinses, however these~     treatments are not always effective and carry a risk of systemic absorption. Mesenchymal~     stem/stromal cells (MSCs) resident in adult and fetal tissues, such as the bone marrow have~     the capacity to form bone, cartilage, stroma, muscle and fat, are known to exhibit~     immunosuppressive and immunoregulatory properties both in vivo and in vitro. MSC infusions~     have been used to treat disorders such as osteogenic imperfecta, cardiovascular disease and~     to heal large bony defects. Indeed, the immunosuppressive capacity of MSCs have led to~     infusions being used as a second-line treatment for GVHD patients, and our group has shown~     within a Phase II clinical trial, 55% aGVHD patients who failed front-line steroid treatment~     responded to MSC infusion these studies are going with cGVHD patients. The goal of this~     project is to perform a pilot study to determine whether MSC injections directly into mucosal~     lesions in patients with oral cGVHD are able to alleviate the symptoms and facilitate the~     reparative process.~   "
115503|NCT02055612|"~     The aim of the study is to find out prevalence of aged-related macular degeneration (AMD) in~     Slovak Republic. The outcome of the project will be epidemiology survey, prevalence of wet~     form of AMD in relation to demographic data, patient´s anamnesis, nutrition, co-morbidities~     etc.~   "
115504|NCT02055599|"~     The goal of this project to begin using a wound research database with clinical decision~     support features at Winthrop University Hospital. A research database is an electronic~     computer system that is used to collect patient information. Clinical decision support is the~     ability for a computer system to provide medical assistance to the doctor through alerts and~     recommendations based on the information entered. The investigators believe that use of a~     wound clinical decision support tool, much like a drug, will improve healing in patients with~     chronic wounds (wounds that fail to heal over the course of weeks) and ultimately lower the~     risk of death and illness caused by these wounds. In order to develop a useful clinical~     decision support tool, investigators first need to develop a large research database to~     determine the data points important for wound healing. The investigators will be using the~     data collected in this study for future research and publication. Data will be reviewed to~     answer questions important to wound healing and for the purpose of developing the clinical~     decision support alert system.~      After providing informed consent, participants will be asked a series of questions related to~     their past medical history, and relevant wound data will be collected. Study staff will~     photograph the wound at baseline, and once per week until the wound is completely healed, or~     for a duration of six months.~      Participants will be expected to return to Winthrop University Hospital for wound follow-up~     on a regular basis, or as determined by the Principal Investigator.~   "
121657|NCT01975103|"~     This trial seeks to prove the safety and efficacy of photothermal stimulation treatment to~     diabetic macular edema, chronic central serous retinopathy, macular edema secondary to branch~     retinal vein occlusion and macular telangiectasia.~   "
115505|NCT02055586|"~     This pilot clinical trial studies fluorine F 18 fluorothymidine (FLT)-positron emission~     tomography/magnetic resonance imaging (PET/MRI) in measuring early response in patients with~     metastatic solid tumors receiving treatment that blocks blood flow to the tumor. Diagnostic~     procedures, such as FLT-PET/MRI, may help measure a patient's response earlier during~     treatment.~   "
115506|NCT02055573|"~     Regular reading with young children strengthens the parent-child relationship and builds~     their language, literacy and social emotional skills. Parent knowledge of normal variation of~     infant crying and of the dangers of shaking a baby as well as their ability to cope with~     infant irritability are likely factors in their successful adjustment to parenthood and the~     prevention of this tragic act.~      Purpose: Identify easily implementable interventions for economically disadvantaged mothers~     in the newborn period which 1) Promote early literacy behaviors and early nurturing~     parent-child relationships and 2) Increase mother's knowledge of normal crying patterns, the~     dangers of shaking a baby and her ability to cope with parenting stresses.~      Design/Methods: A convenience sample of 300 low income (insured by Medicaid) new mothers of~     healthy singleton, full term infants in the level 1 mother/baby unit at Women & Infants~     Hospital will be invited to participate in a Randomized Controlled Trial study of educational~     videos and materials for parents. They will be randomized into one of two intervention~     groups. 1) The Ready to Learn (RTL) arm will receive a DVD in both Spanish and English and a~     bilingual booklet (both produced by Parents' action for Children) addressing the benefits of~     reading, talking and playing with young children, as well as a new children's board book. 2)~     The All Babies Cry (ABC) arm will receive a DVD in both, Spanish and English and a bilingual~     booklet (both produced by VIDA) explaining crying as part of normal infant behavior,~     highlighting signs of parental distress and providing strategies to sooth parents and their~     children. We will enroll 75 mothers who speak Spanish primarily at home in each intervention~     group, as well as 75 mothers who speak primarily English. The RTL mothers will serve as~     controls for the ABC mothers and vice versa. Before reviewing the materials, mothers will be~     asked to respond to a baseline interview with socio-demographic information, questions~     regarding Early Literacy promotion, reading with children and their own reading habits as~     well as general knowledge on the prevention of shaking a baby and handling their own stress.~     Follow up phone interviews will be conducted by a bilingual research assistant blind to the~     intervention status at 2-5 months post-partum containing similar questions. Consenting~     mothers will receive a bag of diapers at the completion of enrollment interview as an~     incentive for participating in the study. Data will be entered into Excel and transferred~     into STATA for analysis. Frequency counts will be generated for demographic, literacy related~     and parental knowledge and stress variables in the two intervention arms. Chi-Square and~     T-tests will be used to compare literacy and parental knowledge outcomes for each~     intervention group at both follow up interviews.~      Hypotheses: 1) Mothers in the RTL branch will recognize the importance of reading to their~     babies, initiating this activity at earlier ages and reading more often with them. 2) Mothers~     in the ABC branch will gain an understanding of crying as part of normal infant behavior and~     build strategies to sooth themselves and their newborns.~   "
115507|NCT02055560|"~     The primary objective of this study is to evaluate whether the management of colorectal~     cancer (CRC) patients with 5-fluorouracil (5-FU) exposure optimization testing reduces 5-FU~     related toxicities and improves outcomes compared to the current standard of care. A~     secondary objective is to characterize the variability of 5-FU levels among CRC patients~     managed with 5-FU exposure optimization testing and the impact of such management on 5-FU~     plasma levels and drug doses during the course of chemotherapy.~   "
115508|NCT02055547|"~     This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of~     MK-8521. The primary hypothesis is that MK-8521 is sufficiently safe and well-tolerated in~     healthy, lean and obese males.~   "
115509|NCT02055534|"~     Poor nutritional status is common in patients with systemic immunoglobulin light-chain (AL)~     amyloidosis and has been associated with mortality and impaired quality of life (QoL). We~     investigated whether nutritional counseling is beneficial to the maintenance of nutritional~     status and QoL in AL outpatients.~   "
115510|NCT02055521|"~     Composite tissue allotransplants (CTA) involve transplantation of various tissues including~     vessels, nerves, skin, bones, and immune cells and entail a significant antigenic load. The~     large majority of recipients have been maintained on immunosuppression therapy similar to~     that used in solid organ transplantation that is associated with the complications usually~     reported in solid organ transplantation. The question whether risks associated with~     indefinite immunosuppressive are justified for a non-lifesaving procedure still remains~     unanswered. At present no CTA recipient proved to be spontaneously tolerant with any~     immunosuppressive protocol; indeed, until now all recipients who discontinued the~     immunosuppressive therapy rejected their graft. On the other hand CTA recipients showed a low~     incidence of chronic rejection despite the high incidence of acute rejection episodes.~      For all these reasons it should be of great interest to minimize the immunosuppression in CTA~     patients knowing their immunologic risk. The main outcome of this study is to search for~     the signature of tolerance in recipients of hand or face allotransplantation testing~     biomarkers previously identified in operational tolerant kidney transplant recipients.~      These markers have been developed studying tolerant kidney recipients and they were already~     tested in five bilateral hand transplantations and one face transplantation.~      The present study will include hand and face allograft recipients transplanted at least one~     year in several European institutions (Innsbruck, Lyon, Monza, Valencia): 11 bilateral hand~     transplantations, 4 single hand transplantations and 3 face transplantations. All the~     patients will undergo B cell phenotyping, TCR repertoire, molecular signature from~     operational tolerance and a skin biopsy with immunohistochemical staining of the specimens in~     order to show signs of acute or chronic rejection.~      The results could provide a valid tool to detect operationally tolerant recipients as well as~     recipients prone to develop chronic rejection.~   "
115511|NCT02055508|"~     The investigators plan to evaluate, in a randomized, controlled phase III trial in patients~     with advanced non-small cell lung cancer (NSCLC), the effects of a 24-week exercise~     intervention program (EIP) on quality of life, physical functioning and immune function~     parameters. Eligible patients (n=250) will be enrolled in the Clinic for Thoracic Diseases,~     Heidelberg, over a time period of two years and followed up for a total of 12 months.~      Patients will be randomized either to EIP plus Care Management Phone Calls (CMPC) versus CMPC~     alone (besides a proper symptom and side effect management CMPC ensures the potential~     influence of social contacts that can be anticipated for the patients in the intervention~     group).~      Our primary aims are to investigate whether a combination of a partly supervised (in- and~     outpatient) and partly home-based endurance and resistance training improves quality of life~     (QoL) and lowers levels of fatigue (evaluation via the standardized and validated~     questionnaires FACT-L and MFI). In addition we propose to evaluate the effects of EIP on~     tumor specific immune responses. Biomarkers of immune function will be measured by cellular~     immunity and cytokine and chemokine panels.~      Further secondary outcomes include measurement of anxiety, depression and demoralization,~     physical performance parameters (e.g. improvement in walk distance, muscle strength), as well~     as overall and progression free survival analyses.~      The study builds on a previous feasibility study of a 8 weeks exercise intervention trial in~     patients with advanced NSCLC with the results being utilized in the design of the here~     proposed trial.~      The investigators hypothesize that patients randomized in the exercise intervention group~     will show improved QoL and reduced fatigue, as well as improved physical functioning and~     increased tumor specific immune responses.~   "
115512|NCT02055495|"~     There is no consensus on the surgical treatment of unremitting, painful flatfeet in children.~     Subtalar arthroereisis has gained notoriety although there is a paucity of literature on its~     biomechanical effects. The goal of the investigators was to compare a group treated with~     subtalar arthroereisis with another group undergoing lateral column calcaneal lengthening.~     The investigators hypothesis was that the results of arthroereisis would be equivalent to the~     more established method of calcaneal lengthening.~   "
115513|NCT02055482|"~     Anaemia is a condition in which blood has a lower than normal number of red blood cells. It~     can also occur if red blood cells do not contain enough haemoglobin, an oxygen carrying part~     of blood. Anaemia is common in patients with chronic kidney disease. Healthy kidneys produce~     a hormone called erythropoietin, which stimulates the bone marrow to produce the proper~     number of red blood cells needed to carry oxygen to vital organs. Chronic kidney disease is a~     general term that means that the kidneys are not functioning to their full potential. The~     study drug, BAY85-3934, is being evaluated as a drug to increase the body's ability to~     produce erythropoietin.~      The purpose of this extension study is to find out if the study drug, a tablet taken orally,~     is safe and effective for the treatment of anaemia associated with chronic kidney disease.~      The extension study will enroll up to 240 patients at multiple locations in Europe, Asia and~     Australia. Patients who participated in Studies 15141 or 15261 may be eligible to take part~     in the extension study. The study consists of the Haemoglobin (Hb) Stabilisation Phase and~     the Main Phase. The Hb Stabilisation Phase involves up to 10 study visits scheduled over 16~     weeks. The Main Phase will last for at least 6 months and up to a maximum of 36 months, with~     visits every 4 weeks. During these scheduled visits patients will undergo a number of~     procedures to confirm efficacy and safety of the study drug, including measurement of heart~     rate and blood pressure, physical examination, Electrocardiogram and blood/urine sample~     collection for laboratory tests.~      The study will be conducted at 5 hospitals in the UK. Bayer HealthCare AG is funding this~     research. This study will include subjects who either completed the treatment period in their~     respective Phase 2 parent study (i.e., Study 15141 or Study 15261) or experienced a stopping~     event in the fixed dose parent study (Study 15141). As Study 15141 is a double-blind study,~     subjects will be unblinded as per the Study 15141 protocol prior to entry into the extension~     study.~   "
115514|NCT02055469|"~     In patients with achalasia, the relationship between the perception of dysphagia, oesophageal~     emptying, lower oesophageal sphincter (LOS) distensibility and oesophageal circular and~     longitudinal muscle contraction is not clear.~      We aim to characterize oesophageal circumferential and longitudinal muscle contractility and~     LOS distensibility in patients with achalasia (either before or after treatment). This may~     allow an understanding of the mechanisms underlying persistent dysphagia and delayed~     oesophageal emptying after treatment.~   "
115529|NCT02055274|"~     The purpose of this study is to characterize the pharmacokinetics (PK) of LY03003 following~     multiple escalating intramuscular injections, as compared to Neupro patch and to evaluate the~     safety and tolerability and preliminary efficacy of multiple ascending dose (MAD) of LY03003~     following intramuscular injections.~   "
121658|NCT01975090|"~     The SENTRY Bioconvertible Inferior Vena Cava (IVC) Filter has been developed to provide~     temporary protection against pulmonary embolism (PE).~   "
115515|NCT02055456|"~     Decrease in blood cell counts due to deficient bone marrow function, called bone marrow~     failure, as well as some lung diseases, called idiopathic pulmonary fibrosis, can be caused~     by genetic defects in telomere biology genes, eventually causing telomere erosion. These~     disorders are collectively termed telomeropathies.~      There is evidence that male hormones may improve blood cell counts in marrow failure, and~     these hormones are able to stimulate telomerase function in hematopoietic cells in vitro. We~     propose this study to the use of male hormone in patients with aplastic anemia and pulmonary~     fibrosis associated with defects in telomeres.~   "
115516|NCT02055443|"~     The purpose of this study is to evaluate whether new novel markers from the clinical~     electrocardiogram (EKG), which have been used as non-invasive measures of heart disease, can~     detect coronary artery disease in patients with chest pain. The researchers are especially~     interested in studying how changes in these unique waves evolve over time with rest and~     activity. It is hoped that the findings will be helpful in differentiating patients with~     cardiac chest pain at emergency departments from those with non-cardiac chest pain, as early~     identification can accelerate treatment and save lives.~      Eligible participants are those age 18 and older who have been referred for a nuclear stress~     test at University of Pittsburgh Medical Center Presbyterian Hospital to rule out coronary~     artery disease as part of their clinical care.~   "
115517|NCT02055430|"~     To compare percutaneous nephrostomy (PCN) versus double J stent (JJ) as an initial urinary~     drainage in children~   "
115518|NCT02055417|"~     In this 3-year study, the investigators will develop and pilot test an intervention called~     Personal Approaches to Treatment Choices for HIV (PATCH). PATCH is a brief intervention~     designed to support participants' decision-making processes and enhance intrinsic motivation~     to initiate ART, using motivational interviewing (MI) techniques. The intervention will be~     targeted at HIV-positive African-American adults in inner-city Baltimore, Maryland who are~     suboptimally engaged in care and who endorse conspiracy beliefs about HIV or low readiness to~     begin ART. The specific aims are: (1) Develop and refine a manual for a brief MI intervention~     to support ART decision-making and reduce the likelihood of ART refusal: (2) Evaluate the~     feasibility and acceptability of implementing the PATCH intervention in a small sample of~     individuals who are African-American, recommended for ART but who are not current taking it,~     and who experience multiple barriers to ART adherence; and (3) Conduct a small randomized~     controlled pilot to test the potential efficacy of the PATCH intervention in producing~     positive attitudinal changes, including a reduction in conspiracy beliefs and perceived~     barriers to ART and stated readiness to begin ART.~   "
115519|NCT02055404|"~     The purpose of this study was to select the size of the molded rotation mark for a new toric~     contact lens by comparing the visibility of various molded rotation marks.~   "
115520|NCT02055391|"~     The purpose of this study is to determine whether a new weight loss treatment which~     incorporates behavioral weight loss skills and skills for learning how to identify, manage,~     and cope with emotions helps with weight loss and emotional eating in people who are~     overweight and eat in response to emotions.~   "
115521|NCT02055378|"~     To compare the effect of myopia control between patients treated with low-concentration~     atropine eye drops combined with auricular acupoint stimulation and those treated with~     atropine alone.~   "
115522|NCT02055365|"~     Vaccines have been responsible for preventing millions of deaths and extending the average~     human lifespan. Effective vaccines stimulate the cells of the immune system to activate genes~     and associated functions that bring about protective immunity.This study aims to define~     cellular functions and genes important for the hepatitis B (HBV) vaccine immune response in~     healthy individuals. The investigators hypothesize that many genes associated with innate and~     adaptive immune functions are important for an effective HBV vaccine response.~   "
115523|NCT02055352|"~     To demonstrate the free combination of budesonide and indacaterol is as efficacious as~     fluticasone and salmeterol in patients with COPD~   "
115524|NCT02055339|"~     Preterm infants born before 28 weeks gestation are at risk for lung disease and require~     oxygen and pressure to keep their lungs open. This usually involves a device called nasal~     continuous positive airway pressure (nCPAP). When preterm babies reach a certain age, they~     are ready to begin to feed by mouth, but for those on nCPAP, oral feeds are usually not~     started due to concerns for choking. This may cause them to miss their window of learning and~     may lead to a longer hospital stay or oral aversion. Sometimes babies are switched from nCPAP~     to low flow oxygen (LFO2) for a short time for oral feeds, but this may not provide enough~     support for their lungs. Heated, humidified high flow nasal cannula (HHHFNC) is another mode~     of providing oxygen and pressure. It is equal to nCPAP in small babies transitioning off of~     ventilators, but no studies have been done in older babies. We plan to compare the feeding of~     babies orally using either nCPAP with LFO2 or HHHFNC in preterm babies born before 28 weeks~     gestation who are now 34 weeks corrected gestational age. The goal will be the fastest time~     to full oral feeds.~   "
115525|NCT02055326|"~     The purpose of this pilot study is to examine the feasibility and preliminary efficacy of a~     quit-smoking program that combines behavioral therapy with either yoga, or a health &~     wellness program that serves as a contact control.~   "
115526|NCT02055313|"~     The main objective of this study is to explore experiences and insights from exceptional~     patients, patients with cancer that were considered by their physicians as having exceptional~     course of survival related to their specific disease state.~      A secondary future objective of this study is to develop an international multicenter~     registry and database documenting and examining the experience of patients with cancer that~     were considered by their physicians as having exceptional course of survival related to their~     specific disease state.~   "
115527|NCT02055300|"~     The purpose of this study is to evaluate the safety and tolerability of escalating single~     oral doses of LY03005 in healthy subjects and to characterize the pharmacokinetics (PK) of~     escalating single oral doses of LY03005.~   "
115528|NCT02055287|"~     The purpose of this study is to characterize the pharmacokinetics (PK) of LY03004 following~     an escalating single intramuscular injection at 12.5, 25, 37.5, or 50 mg; and to evaluate the~     safety and tolerability and preliminary efficacy of LY03004 following intramuscular~     injection.~   "
123289|NCT01953718|"~     The purpose of this study is to assess the impact of different parameters (voltage, pulse~     width, frequency) of subthalamic nucleus (STN) deep brain stimulation (DBS) on motor symptoms~     in patients with Parkinson's disease (PD).~   "
115530|NCT02055261|"~     The appearance of postural instability and gait disorders is a major turning point in the~     evolution of Parkinson's disease (PD). These axial symptoms are usually unresponsive to~     L-Dopa and represent a severe impairment for the patients due to frequent falls and reduced~     outside mobility. There is no effective pharmacological treatment available for these~     symptoms, and their pathophysiology is not well known : it is currently assumed that~     non-dopaminergic brainstem lesions participate to axial symptoms in PD. Surgically, these~     patients cannot benefit from high frequency deep brain stimulation (DBS) of the subthalamic~     nucleus (STN) since this operation tends to even aggravate axial symptoms unresponsive to~     L-Dopa in some patients. A dysfunction of the pedunculopontine nucleus (PPN) might be at the~     origin of these axial symptoms, since the PPN participates in the maintenance of posture and~     motion in primates. In PD patients, recent reports have suggested that low frequency~     stimulation of the PPN may equally improve gait and posture. However, these results are~     debatable due to methodological limitations, insufficient clinical evaluation and uncertain~     anatomical targeting. Thus, our aim is to propose a low frequency PPN stimulation to six~     advanced PD patients according to the usual criteria for STN DBS who are, however, unsuitable~     for this operation due to gait and posture disorders. We will perform a randomized,~     double-blind and cross over design (two months periods with and without DBS randomly assigned~     to each patient). The targeting will be allowed by a a three-dimensional and deformable atlas~     of the basal ganglia fusioned with the stereotaxic magnetic resonance imaging (MRI) of each~     patient. Evaluations will comprise 1 month before surgery and in Off and On stimulation~     condition:~        -  clinical motor assessment in both Off and On drug state, including cardinal~          parkinsonian signs, gait and balance~        -  gait initiation physiological evaluation~        -  cognitive and behavioral testing If our hypothesis is confirmed, low frequency PPN~          stimulation may well represent a substantial improvement of our therapeutic options for~          advanced PD patients suffering from debilitating gait and posture disorders unresponsive~          to L-Dopa.~   "
115531|NCT02055248|"~     Background:~      - Moebius syndrome limits the ability to make facial expressions like smile, frown or blink -~     and move the eyes laterally. It can also cause speech, swallowing or breathing difficulties~     and affect parts of the body, such as the limbs, jaw, muscles, or the heart. Some individuals~     with Moebius can have intellectual impairment or behavior problems. Researchers want to study~     the clinical features of individuals with Moebius or related disorders and explore the~     genetic and/or environmental causes of these conditions.~      Objective:~      - To learn more about the genetics and clinical characteristics of Moebius syndrome and other~     Congenital Facial Weakness disorders.~      Eligibility:~      - People ages 2 to 80 years with congenital facial weakness, isolated or combined with other~     congenital anomalies, and their family members.~      Design:~        -  Participants with Moebius syndrome or other congenital facial weakness disorder will be~          evaluated at the NIH Clinical Research Center over 3 to 5 days and undergo the following~          procedures:~        -  Medical and family history and physical examination, including body measurements and~          vital signs.~        -  Blood or saliva will be collected for genetic tests and to evaluate liver, kidney, heart~          and hormonal~      functions.~        -  Eye examination, including having a video taken of their eyes moving.~        -  Hearing evaluation.~        -  Speech and language assessment, including swallowing studies.~        -  Dental exam.~        -  Detailed neurological evaluation, including electromyogram/nerve conduction and blink~          reflex study.~        -  Rehabilitation medicine evaluation, including muscle and tongue strength testing and~          assessment of balance.~        -  Neurocognitive and behavioral testing and questionnaires to assess quality of life and~          copying mechanisms.~        -  Imaging studies of their head, by magnetic resonance and diffusion tensor imaging~          -MRI/DTI. Participants~      will lie on a table that slides into a metal cylinder that takes images of internal body~     structures using~      magnets. Child participants may be sedated.~        -  Some adults may have additional X-rays of their head or limbs, if there are abnormal~          findings.~        -  Medical photographs of the face and affected body parts may be taken.~        -  Other specialized tests or consultations, as indicated.~        -  Participants can choose to have a skin biopsy taken.~        -  A follow-up visit will be offered to participants for review of genetic test findings~          and possibly additional clinical tests, as indicated.~      Family members of the patients will have a medical and family history and physical~     examination. Blood or saliva will be obtained for genetic studies.~   "
115532|NCT02055235|"~     Background:~      - Different people perceive the same pain differently. Mood, attention, stress, and~     personality affect how we feel pain. Researchers want to know whether people who do yoga~     perceive pain differently than people who do not practice yoga, meditation, or martial arts.~     They also want to study if cortisol, a stress hormone, relates to pain or brain differences.~      Objective:~      - To study the effects of yoga on the body s stress response, pain perception, and the brain~     s structure and pain response.~      Eligibility:~        -  Right-handed adults 30 years and older who practice yoga regularly.~        -  Healthy right-handed volunteers 30 years and older who do at least mild exercise but no~          yoga or martial arts.~      Design:~        -  Visit 1: Participants will be screened with medical history and physical exam. They will~          have blood and urine tests and electrocardiogram to measure heart activity.~        -  At home, participants will wear a heart monitor for 1 day and collect 5 saliva samples~          daily for seven days.~        -  Visit 2: Participants will undergo tests in a chair or in a mock MRI machine. They will~          lie on a table that slides into a cylinder.~        -  A heating device will be placed on their leg and heated periodically for few seconds at~          a time.~        -  They will give saliva samples.~        -  Heart rate, respiration, etc. will be monitored.~        -  They will fill out questionnaires.~        -  Visit 3: Participants will answer questions and repeat Visit 2 tests. Tests will be done~          in the real MRI machine. The scanner makes loud knocking sounds. Participants will get~          earplugs. Participants will be in the scanner about 1 hour with a coil over their head.~   "
115533|NCT02055222|"~     Despite the implementation of modern public health interventions, 1 in 5 adults in the United~     States are either current or former smokers and remain at risk for the development of chronic~     lung diseases. It is unknown how or why any one individual smoker can develop a wide range of~     lung diseases including chronic obstructive lung disease and/or pulmonary fibrosis. The~     purpose of this protocol is to collect clinical data, blood, urine, and bronchoalveolar~     samples from smokers and non-smokers in an attempt to establish phenotypic clinical profiles~     that correspond to divergent pathways in the expression of such proteins as the transforming~     growth factor-beta1 (TGF- <=1). The information generated from this study will provide~     insight into the pathogenesis of smoking-related lung injury and potentially allow for the~     development of early therapeutic interventions.~   "
115534|NCT02055209|"~     Our objective is to develop a community-based cohort and novel genomic science resource for~     defining the biological significance of ancestry-related genomic variation in~     African-Americans within the GENE-FORECAST :GENomics, Environmental FactORs and the Social~     DEterminants of Cardiovascular Disease in African Americans STudy. This resource will enable~     our team to test the working hypothesis that race-ancestry differences in the burden of~     cardiovascular disease (CVD) reflects the influence of a unique interplay between the~     distinct genomic variation characteristic of African-Americans (AA) and the exposome of~     social determinants and environmental factors that influence the pathogenesis of CVD in AA.~     The specific aims are:~      AIM I. To examine the associations between common or ancestry-related DNA variants and CVD~     risk factors (e.g. hypertension) and phenotypes (e.g. coronary artery calcification) in~     African-Americans (AA).~      AIM II. To examine the associations between health behaviors or social-environmental factors~     and CVD risk factors and phenotypes in AA.~      The study is designed to create a cohort amenable to nested case-control analyses based on a~     community-based sampling frame with a target size of approximately 1800 self-identified, US~     -born, African-American (AA) men and women (ages 21-65) to be recruited over the next 5-6~     years from the metropolitan Washington DC, Montgomery County (MC) and Prince George s County~     (PG) areas to be recruited to the NIH Clinical Center. The initial participant recruitment~     strategy involved two approaches: 1) a random-digit telephone screening survey targeting~     study-eligible AA that will be consented and invited to an evaluation visit in the NIH~     Clinical Center which we contracted with a well-established survey group (Southern Research~     Group [SRG]); and 2) a community outreach effort to recruit participants into the Clinical~     Center by leveraging marketing and the engagement of community-based leaders, organizations~     and faith-based institutions in the area. We are no longer contracting with SRG but rather~     focusing on community outreach and marketing for recruitment to the Clinical Center. The~     contract with SRG was terminated after the first two years of the protocol due to low yield~     of recruitment to the Clinical Center compared to community outreach.~      Given the high burden of CVD among AA, this approach will yield a sample with normal~     individuals as well as a high proportion of AA with CVD risk factors such as obesity and~     hypertension that predispose to the eventual clinical signs and symptoms of CVD (e.g. heart~     attack and stroke). Based on previous epidemiology studies, this protocol s participant~     ascertainment approach and the target demographic profile; it is anticipated that the~     prevalence of clinically manifest CVD (history of angina, heart attack or stroke) will be~     less than 10-15% of the sample. All participants will undergo extensive evaluation in the~     Clinical Center that includes: medical evaluation (e.g. anthropometrics, blood pressure),~     laboratory tests (e.g. lipid levels, kidney function), social determinants profiles (e.g.~     socioeconomic status (SES), perceived stress, discrimination, depression, perceived~     neighborhood characteristics), blood/urine collection for deep-sequencing based omic analyses~     (e.g. whole exome sequencing, and RNA-Seq), as well as testing for pre-clinical , biomarkers~     of the pathobiological processes of CVD or CVD phenotypes (e.g. coronary artery~     calcification, microalbuminuria, leukocyte telomeres, or vascular dysfunction). It is~     anticipated that these deep sequencing efforts will yield novel ancestry-related DNA variants~     associated with the CVD phenotypes; yet with unclear biological significance in elucidating~     racial disparities in CVD. Accordingly, our protocol also includes a Genotype-to-Phenotype~     (G2P) component that re- contacts subsets of the cohort based on their genotype (e.g. APOL1~     chronic kidney disease risk alleles) for a call-back visit for more in-depth phenotyping and~     characterization of the potential effect of the DNA variant of interest on human systems~     biology. In some cases family members of the proband may also be invited to participate in~     these G2P studies to further characterize the biological significance of these putative~     functional DNA variants of interest.~      The primary outcome variables involve well established CVD phenotypes: 1) CVD risk factors~     (e.g. hypertension, dyslipidemia), 2) markers of pre-clinical CVD (i.e. coronary artery~     calcification, coronary plaque burden by cardiac CT angiography (CTA), carotid plaque burden~     by 3D ultrasound, vascular dysfunction, microalbuminuria, C-reactive protein, Vitamin D~     levels). The protocol will assess exposures associated with CVD and relevant covariates~     including: 1) social determinants (e.g. socioeconomic status (SES), perceived stress,~     discrimination, and depression); 2) environmental factors s...~   "
115535|NCT02055196|"~     This phase I trial studies the side effects and best dose of genetically modified stem cells~     when given together with irinotecan hydrochloride in treating patients with recurrent~     high-grade gliomas. Irinotecan hydrochloride may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth. Placing a gene that has been created in the~     laboratory into neural stem cells and injecting it into the brain may help irinotecan~     hydrochloride kill more tumor cells once it reaches the brain.~   "
115536|NCT02055183|"~     The purpose of the Registry will be to evaluate patient safety following Botulism Antitoxin~     Heptavalent (A, B, C, D, E, F, G) - (Equine) (BAT®) administration in adult and pediatric~     patients with a confirmed or suspected exposure to botulinum toxin. This Registry is intended~     to serve as an active surveillance system to further assess the safety profile for BAT® and~     to quantify the occurrence of unexpected adverse events, given that the current safety~     database is considered too small to reliably identify unexpected risks.~   "
115569|NCT02054741|"~     This cluster randomized clinical trial compares a geriatric assessment intervention with~     usual care for reducing cancer treatment toxicity in older patients with cancer that has~     spread to other places in the body. A geriatric assessment may identify risk factors for~     cancer treatment toxicity and may improve outcomes for older patients with advanced cancer.~   "
115537|NCT02055170|"~     The purpose of this study is to study the effect of hormone therapies (androgen pathway~     modification) on the outcomes of patients with lung cancer. This information may be of~     benefit for future treatment strategies, prevention and control.~      In this study, the protein where testosterone binds, called the androgen receptor (AR), will~     be measured in samples from the patient's biopsy and surgical tumor samples. The~     investigators will look at a marker of how fast the cancer is growing (Ki67) before using~     finasteride from your biopsy specimen. Finasteride will be taken from the day of consent~     until the day of the patient's surgery. This marker will be measured again after using~     finasteride from the surgical specimen. The investigators will be looking for a decrease in~     the Ki67 from the patient's biopsy specimen to the surgical specimen as an indicator that~     this medication is blocking tumour growth.~   "
115538|NCT02055157|"~     This is a Phase 2, open-label, sequential cohort dose-escalation study of BMN 111 in children~     with achondroplasia. The primary objective is to assess the safety and tolerability of daily~     BMN 111 administered to children with achondroplasia.~   "
115539|NCT02055144|"~     VeriStrat® is a pretreatment blood-based test correlated with clinical outcome after EGFR-TKI~     therapy in non-small cell lung cancer (NSCLC) patients.~      The investigators hypothesis is that VeriStrat could be also employed as a biomarker of~     benefit from treatment with standard chemotherapy regimens in first line NSCLC patients.~   "
115540|NCT02055131|"~     This is a prospective study consisting in testing whether systematic use of aspirin is~     beneficial for primary prevention of vascular access for hemodialysis attested by doppler~     ultrasound exam. The investigators will study aspirin resistance in the population of~     patients undergoing hemodialysis. The investigators will test sensibility of resistant~     patients to aspirin dose escalation. PFA-100 is the biologic test used in this study to~     define aspirin resistance.~   "
115541|NCT02055118|"~     Study HGT-HIT-094 is a multicenter study designed to determine the effect on clinical~     parameters of neurodevelopmental status of monthly IT administration of idursulfase-IT 10 mg~     for 12 months in pediatric patients with Hunter syndrome and cognitive impairment who have~     previously received and tolerated a minimum of 4 months of therapy with Elaprase.~   "
115542|NCT02055105|"~     The goal of this study is to demonstrate the sensitivity and specificity of detecting~     circulating micro RNA (miRNA) biomarkers in pediatric septic patients. It will also follow~     expression and modulation of levels in response to therapy in comparison to current~     biomarkers.~   "
115543|NCT02055092|"~     People diagnosed with young onset dementia are today mostly assigned to the same healthcare~     services as people developing dementia at an older age. They and their families are however~     in a quite different life situation, which is likely to generate different challenges and~     specific needs for tailored healthcare services, of importance in maintaining their perceived~     quality of life.~      The investigators of this study wish to assess the factors influencing these families'~     quality of life, their specific needs and their use of healthcare services by the use a~     combination of quantitative and qualitative methods. The main aim of this study is to provide~     better future healthcare services to these families, and to develop a programme for optimal~     collaboration between specialist healthcare services and the local dementia teams.~   "
115544|NCT02055079|"~     Sirolimus (SIR) has lead to a reduction of overall kidney size, a decrease in cyst density~     and general tubular cell proliferation in animal models, and to a reduction of the increase~     in creatinine and blood urea nitrogen by 34 and 39 percent respectively, as well as a~     reduction of cyst proliferation, expressed by a 30 percent reduction of overall kidney~     enlargement, a reduction in general cyst volume, and a reduction of the cyst volume density~     in the renal cortex in humans.~      However, despite promising data from animal- and in vivo studies, most mammalian target of~     rapamycin inhibitor (mTOR-I) studies in patients with autosomal-dominant polycystic kidney~     disease (ADPKD) produced only subtle if any clinically relevant effects on cyst growth and~     the preservation of renal function.~      In this study we will investigate if pulsed administration of SIR in a fixed weekly oral dose~     of 3 mg over 24 months compared to placebo significantly reduces cyst growth and preserves~     excretory renal function in patients with ADPKD and an estimated glomerular filtration (eGFR)~     rate below 60 mL/min per 1.73m2.~   "
115545|NCT02055066|"~     This a first-in-human study of an antibody blocking the function of the oncogene c-met in~     patients with cancer.~   "
115546|NCT02055053|"~     To assess effect of local anesthetic into the preperitoneal space during laparoscopic hernia~     repair on post-operative pain.~   "
115547|NCT02055027|"~     Prospective study designed to identify factors that would predict patient adherence to CPAP~     (Continuous Positive Airway Pressure) therapy.~   "
115548|NCT02055014|"~     New effective non-surgical treatments are needed for patients whose obesity and type 2~     diabetes (T2DM) do not respond to current medical therapies. We propose a randomised~     controlled trial of Endobarrier, an implantable intestinal device that separates ingested~     food from contacting the first 60cm of intestine where sited and that mimics some of the~     clinical effects of bariatric surgery (improved metabolic control with weight loss) with or~     without continued use of the GLP-1 receptor agonist (GLP-1RA) Liraglutide 1.2mg vs~     Liraglutide 1.8mg without the device in obese patients with T2DM who remain with suboptimal~     glycaemic control despite current conventional diabetes treatment, in an NHS setting.~      Seventy-two patients with T2DM and obesity (HbA1c≥7.5%, BMI≥35kg/m2) despite previous GLP-1RA~     therapy will be studied over 24 months and randomised to receive Endobarrier with continued~     Liraglutide 1.2mg for 12 months; Endobarrier alone for 12 months; or Liraglutide 1.8mg~     without Endobarrier.~      We will investigate potential mechanisms of action and their time course as part of the study~     by repeated measures of: 1. insulin resistance measures, gut peptides, bile acids; 2. energy~     intake and nutritional composition; 3. liver fat stores, 4. intestinal inflammation and~     permeability measures.~      The data will inform clinical use of the device and development of new treatments for T2DM~     and obesity.~   "
115570|NCT02054728|"~     The purpose of this study is to assess hemodynamic effects of inspiratory muscle training~     during routinely performed right-heart catheterization.~   "
116434|NCT02043470|"~     The investigators propose using retinal oximetry to assess for abnormalities in regional~     retinal oxygen consumption in previously- irradiated patients, and relate these abnormalities~     to changes in regional retinal function (i.e. visual field abnormalities). Since different~     regions of retina receive different radiation doses, the investigators will assess for a dose~     response as well.~   "
115549|NCT02055001|"~     Atherothrombotic disorders account for 25% of all deaths among women and for substantial~     morbidity and resource use in health care. Nonetheless, gender-related differences in the~     epidemiology of cardiovascular disease (CVD) remain largely unexplained. Among mechanisms~     that could account for such differences, the biology of platelets, which exert a pivotal~     pathogenetic role in atherothrombosis, and of coagulation system are on investigation.~      Thus, differences in platelet reactivity between women and men have been described using~     several methods and in response to varying stimuli. Indeed, sex steroid hormones could be~     involved in a different response of platelet to physiological response to agonists. The~     finding that estrogen receptors are expressed in platelets makes these cells an excellent~     model for studying the non-genomic effects of steroid hormones. Also coagulation cascade has~     been reported to be influenced by sexual endogenous as well as exogeneous hormones (i.e~     contraceptives) In particular, the impact of endogenous estrogens (menstrual cycle) on~     platelet activity and on response to antiplatelets drugs in fertile women has never been~     evaluated.~      Accordingly, the goal of this proposal is to investigate relationship between platelet~     function (assessed by aggregometry tests and markers of platelet activation in vivo such as~     thromboxane production, CD40L and P- selectin levels) and sex hormones during physiological~     regular menstrual cycles (28-30 days) in healthy pre-menopausal women aged from 18 to 40~     years. Moreover, in a subgroup of healthy women free from antiplatelet drugs, will be planned~     a proof of concept study to investigate if there will be variations, during a short term (1~     month) low dose aspirin, in platelet reactivity according to the different phases of~     menstrual cycle in 10 healthy premenopausal women aged from 18 to 40 years. Moreover, it will~     be investigate effect of steroid hormonal pattern on residual platelet activity response on~     treatment~   "
115550|NCT02054988|"~     Prasugrel is a potent thienopyridine antiplatelet agent that selectively and irreversibly~     inhibits ADP-induced platelet aggregation mediated by the P2Y12 receptor. Prasugrel is a~     prodrug that must first undergo biotransformation to its active metabolite via cytochrome~     P450-mediated hepatic metabolism (CYP1A2). Clopidogrel is currently administered to several~     million patients especially after coronary stenting. Clopidogrel has been shown to reduce~     cardiovascular complications in patients with acute coronary syndromes and patients who have~     undergone coronary stenting. The mechanism of action of clopidogrel's active metabolite~     involves inhibition of the purinergic adenosine diphosphate (ADP) receptor P2Y12 on the~     platelet membrane. Blockade of this receptor prevents uncoupling of the associated Gi2~     protein which ultimately leads to increased platelet cyclic AMP (cAMP) formation.3 Cyclic AMP~     is a key signaling molecule in inhibiting platelet aggregation, but its intracellular levels~     are affected by several other commonly used compounds. For instance, methylxanthines, such as~     caffeine, theophylline, and theobromine (an ingredient of chocolate), all cause elevation of~     intracellular cAMP levels by inhibiting adenosine receptors (types A1 and A2) on the platelet~     membrane. The effect of caffeine consumption on platelet reactivity depends on the caffeine~     dose and duration of administration. Chronic caffeine consumption (≥7 days) appears to be~     associated with inhibition of platelet aggregation, probably through upregulation of~     adenosine receptors.The aim of this study was to examine the effect of acute caffeine~     consumption, at a dose equivalent to commercial coffee drinks, on the antiplatelet effect of~     clopidogrel and prasugrel, in patients with coronary artery disease (CAD).~      Platelet function will be evaluated using a validated method: the VerifyNow System~     (Accumetrics Inc., San Diego, CA), which is a point-of-care turbidimetry-based optical~     detection system that measures platelet-induced aggregation.~   "
115551|NCT02054975|"~     This is a pilot randomized controlled trial of lower vs. higher dose vitamin D~     supplementation in D-deficient asthmatic children, to determine necessary sample sizes for~     outcome measures in a larger multisite study, and to examine possible relationships and~     effect sizes between various biological markers that may be important to the pathophysiology~     of childhood asthma.~      Aims of the study are to:~        1. Evaluate effect sizes for relationships between serum 25OH-vitD and omega-fatty acid~          (FA) biomarkers, before and after supplementation with lower or higher dose vitamin D,~          on immune function, and asthma severity.~        2. Characterize changes in innate and adaptive immune function and inflammatory responses~          in asthmatic D-deficient youth at baseline and after vitD supplements, by dietary~          O6:O3FA status and vitD dose.~   "
115552|NCT02054962|"~     Chronic problems after traumatic events are common in non-elderly adults. Previous studies~     have shown that after minor motor vehicle collision (MVC), 10-30% of non-elderly adult~     patients develop chronic regional pain (neck or back pain). In addition, up to 1/3 of~     non-elderly adults will develop psychological sequelae, including posttraumatic stress~     disorder, depression, and anxiety disorders. There have been no prospective studies examining~     the frequency or predictors of persistent pain or psychological sequelae in older adults. The~     proposed study seeks to determine the frequency of persistent pain, psychological sequelae,~     and associated disability in older adults after minor MVC trauma and to identify candidate~     predictors for a model of adverse outcomes after MVC in this population. 200 individuals over~     65 years of age will be recruited from emergency departments in four states with no-fault~     accident laws. Patients who meet inclusion criteria and who consent to the emergency~     department (ED) study will undergo a 30-45 minute ED assessment of crash-related,~     psychosocial, and biological factors, and complete telephone follow-ups at 2 weeks, 6 weeks 6~     months, and 12 months. The wealth of information gained from this study will be used to~     determine the frequency of adverse events in older adults after MVC and to identify high risk~     elderly patients. These results will inform subsequent development of secondary pharmacologic~     and/or behavioral interventions to prevent chronic pain and psychological sequelae after~     traumatic events in older adults.~   "
115553|NCT02054949|"~     This is a study to find out whether the dietary amino acid supplement, N-acetyl cysteine~     (NAC) is helpful in reducing the frequency of seizures in children with autism and comorbid~     epilepsy whose seizures are not responding well to usual medical treatment. The study is also~     looking to see if this supplement is helpful for immediate and ongoing treatment of symptoms~     of irritability. Additionally, this study will also look to see if certain substances in the~     blood that measure a specific type of stress on cells in the body can help tell us how NAC~     may be helping.~   "
115554|NCT02054936|"~     To compare side effects and complications relating to use of warfarin or rivaroxaban,~     tolerance and/or toxicity of these two agents such as drop in hemoglobin post operatively,~     extent of bruising, quantity of wound drainage, duration of drainage, wound swelling, sub and~     supra-therapeutic prothrombin times, need for transfusion, and patient tolerance in two~     randomized groups. Return visits to the operating room, length of stay, and VTE rates will~     also be compared.~   "
115571|NCT02054715|"~     This randomized clinical trial compares multimedia psychoeducation to print education in~     preparing patients with cancer for decision making about clinical trial participation.~     Multimedia psychoeducation includes a digital video disc (DVD) and written materials with a~     combined focus on knowledge and attitude change, and may be an effective method to help~     patients prepare for decision making about clinical trial participation. It is not yet known~     whether a multimedia psychoeducation is more effective than print education in preparing~     patients for decision making about clinical trials.~   "
115572|NCT02054702|"~     The purpose of this study is to explore changes in efficacy, cognitive functioning, and~     safety of flexibly-dosed Brexpiprazole monotherapy in subjects with acute schizophrenia~   "
116449|NCT02043275|"~     The purpose of this study is to determine if jump landing mechanics in young female athletes~     can be improved with a resistance training intervention.~   "
115555|NCT02054923|"~     Routine video recording of the colonoscopy examination has been proposed as a simple and easy~     to implement method that could improve the quality of colonoscopy. The purpose of this study~     is to investigate whether implementation of routine video recording of screening colonoscopy~     withdrawal is effective as a means of supporting quality performance of colonoscopy. The~     study will be performed in 8 screening centers within the framework of a national colonoscopy~     screening program in Poland (the Polish Colonoscopy Screening Platform; PCSP). Individuals~     aged 55-64 years are eligible to participate in the PCSP. In the run-in period colonoscopy~     quality measures will be monitored through a dedicated joint database. Then eligible~     screening centres will be randomly assigned in a 1:1 ratio to the video recording group or~     the control group. Screening centres assigned to the video recording group will receive~     videorecorders and DVDs and will be asked to video record all screening colonoscopies (only~     withdrawal). Control group will be allowed to record colonoscopies on demand only. Then , the~     colonoscopy quality measures will again be monitored through a dedicated joint database. All~     the recorded DVDs will be reviewed to verify ceacal intubation and withdrawal time by the~     PCSP team.~   "
115556|NCT02054910|"~     This study assesses the pain response to Endoscopic Ultrasound (EUS) guided Celiac Plexus~     Block (CPB) treatment in comparison to EUS without a pain block administered. All~     participants will receive medications for pain as needed.~   "
115557|NCT02054897|"~     This trial is conducted globally. The aim of this trial is to investigate efficacy and safety~     of semaglutide once-weekly versus placebo in drug-naïve subjects with type 2 diabetes.~     (SUSTAIN™ 1-Monotherapy).~   "
115558|NCT02054884|"~     There is no standard treatment for Merkel cell carcinoma(MCC), as no randomized trials have~     been conducted to establish standard of care. Despite a sizable number of objective responses~     induced by combination cyototoxic chemotherapy, a prolongation of patients overall survival~     has never been demonstrated.~      This open-label, randomized, double-arm, multi-centre, phase II study of F16IL2 in~     combination with paclitaxel versus paclitaxel monotherapy, proposes to test the therapeutic~     efficacy of F16IL2 plus paclitaxel in patients with metastatic Merkel cell carcinoma, who are~     not amenable to surgery.~      A total of 90 patients with Merkel cell carcinoma will be enrolled and treated during the~     study; 45 patients will receive the combination treatment of F16IL2 and paclitaxel (Arm A),~     and 45 patients will receive paclitaxel monotherapy (Arm B).~   "
115559|NCT02054871|"~     This study aims to demonstrate if remote ischaemic preconditioning (RIPC) may confer renal~     protection in patients undergoing peripheral angioplasty. Patients will be randomised to~     receive RIPC and biomarkers for renal injury will be analysed post procedure to determine if~     any protective benefit was obtained.~   "
115560|NCT02054858|"~     This study aims to assess if applying an ischaemic insult to an arm before giving intravenous~     contrast will help decrease the incidence of developing contrast induced acute renal injury~     in patients undergoing contrast-enhanced CT Scans.~      The main research question is 'In adult in-patients undergoing contrast-enhanced CT scans,~     does remote ischaemic pre-conditioning (RIPC) induced by brief arm ischaemia and reperfusion,~     when compared to control, reduce the proportion of patients developing contrast-induced acute~     kidney injury in the first 3 post-scan days? '.~   "
115561|NCT02054845|"~     Approximately 60% of the patients with Parkinson's Disease (PD) that receive Levodopa therapy~     eventually develop response fluctuations in motor symptoms, such as rigidity, freezing and~     akinesia. Patients experience an 'off'-period just before the next dose of dopaminergic~     medication is needed, called the 'wearing-off'-phenomena. Wearing-off is also accompanied by~     non-motor symptoms such as depression, anxiety, pain and thinking disability. Together, these~     motor and non-motor symptoms have a major impact on the quality of life of patients and their~     partner or caregiver.~      Patients with wearing-off often experience severe anxiety and panic symptoms that are~     incongruent with the severity of the motor symptoms during an 'off' period. These symptoms~     include stress, dizziness, pounding/racing of the heart, dyspnoea and hyperventilation. This~     type of anxiety is called wearing-off related anxiety (WRA) and might be a consequence of the~     hypersensitivity towards somatic manifestations and effects of a wearing-off period. This~     bodily misperception can have major consequences for the patient's feelings and behaviour.~     The experienced anxiety is often not consciously linked to the wearing-off and is therefore~     not well recognized by neurologists.~      Treatment as usual in response fluctuations is physiotherapy, consisting of physical~     exercises for mobility problems, freezing, dyskinesias, etc. This kind of training hardly~     touches upon the mental aspects and the role of anxiety as integral element of the response~     fluctuations. Cognitive behaviour therapy (CBT, including exposure in vivo) is sometimes used~     to treat WRA, but seems to have unsatisfactory results since the changed body awareness is~     not sufficiently addressed. Also, the methods used in cognitive therapies focus on the~     elimination of WRA which is often not realistic since wearing-off symptoms will remain or~     even increase during disease progression. As of yet, there are no known alternative~     intervention options. This study focuses on a new intervention by integrating elements from~     physiotherapy, mindfulness, CBT (mainly exposure), Acceptance and Commitment Therapy (ACT)~     and psycho-education.~      Objective: The current proposal aims at investigating the effect of a multidisciplinary~     non-verbal intervention on the awareness and modulation of WRA to improve self-efficacy,~     mobility, mood, and quality of life as compared to usual care.~      Study design: Randomized controlled clinical trial.~      Study population: Thirty-six PD patients who experience WRA.~      Intervention: Patients with PD are randomly allocated into one of two groups (n= 18 each).~     One group receives the experimental 'body-awareness therapy', while the second group receives~     regular group-physiotherapy (treatment as usual). Both interventions will take 6 weeks in~     which 2 sessions per week with a duration of 1,5 hour will be performed.~      Main study parameters/endpoints: The General Self-Efficacy Scale is the primary outcome~     measure and will be assessed prior to, directly after and 18 weeks after the intervention.~   "
115562|NCT02054832|"~     The aim of the present study is to determine if there is a change in quality and quantity of~     sleep perceived by adults and children with GSD and their parents while starting a modified~     UCCS (Glycosade) to prevent nocturnal hypoglycemia. The investigators also aim to evaluate if~     there is a change in quality of life perceived by adults and children and their parents with~     Glycosade.~   "
115563|NCT02054819|"~     It is the hypothesis of this protocol that a subset of NSCLC patients with stage IVa disease~     can benefit from curative therapy and extends beyond the very limited subset of~     oligometastatic patients that have already been studied.~   "
115564|NCT02054806|"~     This study will assess the efficacy and safety of pembrolizumab (MK-3475) administered to~     participants with incurable advanced biomarker-positive solid tumors that have not responded~     to current therapy or for which current therapy is not appropriate.~      The study hypothesis is that administration of pembrolizumab to participants with some types~     of solid tumors will result in a clinically meaningful response rate.~   "
115565|NCT02054793|"~     This research is being done to test the safety and anti-cancer activity of the combination of~     an investigational drug called orteronel, with a drug called itraconazole in the treatment of~     castration-resistant prostate cancer.~      Orteronel is an investigational drug known as a 17,20-lyase enzyme inhibitor, meaning that it~     blocks the formation of male sex hormones.~      Itraconazole is approved by the Food and Drug Administration (FDA) for the treatment of~     various fungal infections such as fingernail/toenail infections and other more serious fungal~     infections. While it has shown evidence of activity against prostate cancer in prior studies,~     it is not approved for use in cancer. The FDA is allowing the use of orteronel and~     itraconazole in this research study. In addition to its antifungal properties, itraconazole~     was discovered to function to block angiogenesis (blood vessel formation to tumors) to block~     a cellular pathway thought to be important in prostate cancer known as the Hedgehog pathway.~      Investigators hypothesize that blocking male sex hormone production with orteronel will~     increase reliance on the Hedgehog pathway in prostate cancer cells which can then be blocked~     with itraconazole and that the combination of these two drugs will be more effective than~     either alone.~   "
115566|NCT02054780|"~     The purpose of this study is to compare the effectiveness of two types of counseling,~     Psychosocial Counseling (PC) and Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), in~     addressing outcomes of orphans and vulnerable children (OVC) including mental and behavioral~     health, well-being, social support, and HIV risk behaviors. The study will be conducted in~     Lusaka, Zambia.~   "
115567|NCT02054767|"~     The purpose of this study was to compare the anesthetic efficacy of articaine, lidocaine and~     mepivacaine in patients with irreversible pulpitis of mandibular molar.~   "
115568|NCT02054754|"~     The purpose of this study is to test the safety and observe the pharmacokinetics~     (distribution and elimination of the drug) of the compound dexanabinol (ETS2101) in healthy~     male subjects following a single oral dose.~   "
116450|NCT02043262|"~     The purpose of this study is to determine whether a special kind of rehabilitation offered to~     home-dwelling older adults is effective with regards to functional ability and municipal~     costs.~   "
115573|NCT02054689|"~     This is a research trial that seeks to break up the total radiation dose into multiple~     smaller radiation treatments, termed fractionated stereotactic radiosurgery (FSRS) which may~     make the treatment feasible. Fractionated sterotatcic radiation, the risks of FSRS, and~     possible costs will be described later in this document. This clinical trial is for people~     who have had no prior whole brain radiation.~   "
115574|NCT02054676|"~     The purpose of this study is to evaluate validation and clinical assessment of the earlier~     proposed clinical and radiological classification of the jawbone anatomy in endosseous dental~     implant treatment.~      Expected results.~        -  high accuracy of proposed classification for proper implantation risk degree evaluation.~        -  the proposed classification system based on anatomical and radiological jawbone quantity~          and quality evaluation will be a helpful tool for planning of treatment strategy and~          collaboration among specialists.~        -  good interobserver reliability of clinical and radiological edentulous jaw segment~          evaluation.~        -  good reliability between radiological and intraoperative investigations and~          postoperative data.~   "
115575|NCT02054663|"~     After a heart attack patients are routinely started on drugs to inhibit platelets. Ticagrelor~     is a powerful anti-platelet drug with clinical benefits. However it must be discontinued in~     some, because of increased risk of bleeding or intolerance. These patients need to be~     transitioned to another agent, such as Clopidogrel. At present, there is no clinical~     consensus on the optimal strategy for this switch. Some clinicians elect to give a bolus dose~     of clopidogrel with 600mg, while others start directly with a 75mg daily dose, with no~     evidence regarding the benefits or potential complications associated with each strategy. The~     present proposal will evaluate the pharmacodynamics of 2 strategies with specialized platelet~     function testing. We hypothesize that a bolus dose of clopidogrel during the switch will~     confer better ischemic protection without increasing bleeding risk for patients undergoing a~     switch in therapy.~   "
115576|NCT02054650|"~     The study hypothesis is based on osteopathic medical philosophy that: 1) the body is a unit;~     2) the body has inherent self-regulatory mechanisms; 3) structure and function are~     interrelated; and 4) rational treatment is based on an understanding and integration of these~     concepts. Patients with type 2 diabetes mellitus often report more aches and pains than~     people without diabetes. Because osteopathic manual medicine addresses dysfunction in the~     musculoskeletal system, patients with both chronic low back pain and type 2 diabetes mellitus~     may benefit from this non-pharmacological treatment to reduce their pain, thereby reducing~     their stress and perhaps providing better clinical control for diabetes as demonstrated by~     key markers such as hemoglobin A1c and kidney function. This study is an extension of~     research completed in the OSTEOPATHIC Trial. Results of that study were published in the~     Annals of Family Medicine in March/April 2013.~   "
115577|NCT02054637|"~     Somatostatine induces a dose-dependent reduction of postprandial plasma cholecystokinin (CCK)~     secretion with a concomitant inhibition of postprandial gallbladder contraction, abolishing~     almost completely bile salts output from the gallbladder. Somatostatine is also known to~     decrease acid production with significant increase of intragastric pH. In this way,~     somatostatine could influence acid as well as non-acid reflux by decreasing gallbladder~     emptying and decreasing acid secretion.~      Purpose of the study is to evaluate the efficacy of lanreotide autogel 120 mg on symptoms and~     endoscopic lesions in patients with an endoscopic gastrointestinal reflux esophagitis that~     cannot be controlled with classic therapy.~   "
115578|NCT02054624|"~     The purpose of this research study is to learn about ways to help adults with obesity from~     rural areas manage their weight and increase their physical activity. An important goal of~     the study is to find out what type of follow-up program for weight management is necessary to~     help adults with obesity keep from regaining lost weight. The study will also look at the~     ways that long-term weight-loss treatments affect blood pressure, blood fats (lipids), blood~     sugar, and physical fitness.~      You are being asked to be in this research study because increased weight and obesity are~     major health problems in the United States. Your weight and height fall in the obese~     category. Adults with obesity have an increased risk of developing health problems such as~     high blood pressure, diabetes, and heart disease. The rates of being overweight and obese are~     higher in rural areas of the United States than in urban and suburban areas of the country.~   "
115579|NCT02054611|"~     Without rigorous, high-quality training materials, the results of the LUNG-SAFE study~     examining the global incidence and outcomes of severe lung failure (acute respiratory~     distress syndrome [ARDS]) could be confused by either under-recognition of patients with, or~     misclassification of patients without, ARDS. This problem has been previously identified with~     the use of the prior ARDS definitions, particularly in patients with milder severity of~     illness. Importantly, the chest x-ray criteria in the ARDS definition has demonstrated only~     moderate reliability when applied by experts, although this can be improved through the use~     of training radiographs (as will be used in this educational module). The investigators~     hypothesize that the training from the educational module will allow more accurate diagnosis~     of ARDS by data collectors/study coordinators participating in the LUNG-SAFE study.~   "
115580|NCT02054598|"~     This study is a multi-site randomized, controlled trial testing the effect of a combined~     intervention that includes a colorectal cancer (CRC) screening decision aid plus patient~     navigation in a diverse, primary care patient population in clinical sites in North Carolina~     and New Mexico.~      Our primary aim is to determine the effect of the intervention on CRC screening completion~     six months after the index visit among all enrolled participants and among Latinos.~     Secondarily, we will determine how this intervention affects screening-related knowledge,~     self-efficacy, intent, and clinical communication, and examine whether these factors mediate~     the effect of the intervention on screening test completion. Lastly, we will explore whether~     insurance status, ethnicity, and patient language preference moderate the effect of the~     intervention on screening.~   "
115590|NCT02054468|"~     This study is designed to determine the effective-doses ED-50 and ED-95 (the doses required~     for a 50% and 95% twitch inhibition, respectively) of the non-depolarizing muscle relaxant~     rocuronium after single-shot or steady-state propofol anesthesia in a clinical setting.~   "
115591|NCT02054455|"~     The aim of the study is to evaluate the potential protective effect of Lactobacillus~     paracasei subspecies paracasei F19 administration on bowel symptom onset in patients with~     gastro-esophageal reflux disease at long-term PPI treatment.~   "
115581|NCT02054585|"~     Dehydration and refusal to eat and drink are common complaints in the Pediatric ED (Emergency~     Department). Most of these children have had an unsuccessful trial of oral rehydration in~     their community service, therefore are treated with IV rehydration. There is no consensus as~     to which IV solution is the best one for rehydration. Children who are unwilling or unable to~     eat and drink produce Keto bodies. Theoretically, addition of glucose to the IV solution~     would prevent catabolic metabolism and reduce the keto bodies blood concentration which~     should lead to a faster objective and subjective improvement of the child's condition.~      The proposed study is a double blind randomized clinical trial. Children will receive either~     NaCl 0.9% or NaCl 0.9% + 5% glucose randomly in numbered bags. The type of solution will be~     known to the pharmacy only.~      Study aims:~        -  Primary aim: to compare the number of hospitalizations among dehydrated pediatric~          patients treated with either one of the IV fluids mentioned above.~        -  Secondary aim: To evaluate for the possibility of hypoglycemia secondary to~          hyperinsulinism as a response to a rapid administration of glucose.~      Study population: The study will include 700 children 6 month to 18 years of age. It will be~     conducted over 18 months in the Pediatric ED of Carmel Medical Center.~      Currently, data regarding the use of dextrose containing solutions is lacking. As dehydration~     is one of the most common medical problems encountered by the physician in the pediatric ED,~     it is of outmost importance to evaluate the optimal IV solution used in this setting.~   "
115582|NCT02054572|"~     The primary objectives of this study were to determine the rate, extent, and routes of~     radioactivity excretion of [¹⁴C]etelcalcetide in feces, dialysate, and urine over time and to~     measure radioactivity concentrations in whole blood and plasma over time.~   "
115583|NCT02054559|"~     To compare the efficacy and safety of chemotherapy alone and combined modality therapy in the~     treatment of localized CD20 (+) diffuse large B-cell lymphoma~   "
115584|NCT02054546|"~     The purpose of this study is to analyze the new biomarkers (TIMP-2 and IGFBP-7) of tubular~     renal cell damage for the prediction of the Cardiac Surgery Associated acute kidney injury.~   "
115585|NCT02054533|"~     Understanding of how best to treat inflammatory bowel disease (IBD) has evolved over the last~     ten years. Evidence now suggests that the most effective therapy early in the course of~     Crohn's disease (CD) and ulcerative colitis (UC) involves the use of immune suppressing~     medications such as the anti-Tumor Necrosis Factor (anti-TNF) agents infliximab, adalimumab,~     and certolizumab. However, many CD and UC patients still ultimately require surgery despite~     the use of these medications. Side effects of the anti-TNF agents include increased risk of~     infections due to their effect on the immune system. Little is known about how use of these~     medications near the time of surgery may affect patients' risks of infection or other~     post-operative complications. The only available studies on this topic have given conflicting~     results. These studies have been limited by the fact that they have been small in size and~     retrospective. Retrospective studies primarily involve chart review as the method of~     identifying potential risk factors for infections and other complications after they have~     already occurred. This method limits both the type and quality of information/data that can~     be collected. The conflicting results have led to variance in practice patterns with regards~     to management of anti-TNF agents, the timing of surgery, and even the types of surgery.~      By enrolling patients at the time of their surgery, collecting extensive information may be~     possible than previously studied on potential risk factors for both infectious and~     non-infectious complications following surgery. Risk factors to be studied will include~     individual patient characteristics, disease characteristics, surgical methods, novel~     characteristics of CT scans and MRIs and extensive medication exposures. The primary~     objective is to determine if exposure to anti-TNF agents prior to surgery increases the risk~     of infection post-operatively. And evaluate exposure to anti-TNF agents by both patient~     history of use and measurement of anti-TNF drug levels at the time of surgery. Monitoring of~     drug levels at the time of surgery has never been utilized in this way to evaluate the risk~     of anti-TNF agents in IBD. However, this has been done to assess the risk of other~     medications in different diseases.~      If anti-TNF agents are found to pose a risk for infectious or non-infectious outcomes in IBD~     patients undergoing surgery, change maybe needed in the way these medications are used around~     the time of surgery. Additionally, by collecting comprehensive information on other potential~     risk factors besides medication use patients at greatest risk for bad outcomes can be~     identified and take protective measures when possible. The aims of this study address the~     CCFA challenge to better define the risks of medical and surgical therapies to improve the~     quality of care of IBD patients undergoing surgery.~   "
115586|NCT02054520|"~     The purpose of this study is to examine the effectiveness of immune checkpoint inhibitors~     (drugs called ipilimumab, nivolumab, or pembrolizumab), either given alone, or in combination~     with the experimental immunotherapy drug, dorgenmeltucel-L, for melanoma. We hypothesize that~     this form of combinatorial immunotherapy will result in tumor stabilization or shrinkage,~     significant prolongation of progression-free, disease-free or overall survival compared to~     the use of immune checkpoint inhibitors alone.~   "
115587|NCT02054507|"~     The main purpose of this study is to better evaluate prematurely born children cognitive~     development at school age, with regards to birth conditions but also to social situation,~     intra family relationships, and modalities of care.~      The study will be divided into 3 parts:~        1. Children born prematurely in our level III referral Center will undergo psychometric~          evaluation at 8 to 11 years of age by routine cognitive test. The relationships between~          cognitive scores and neonatal characteristics will be determined and compared to the~          results of schoolmates born at term.~        2. The quality of parent and child relationship will be evaluated by a standardized~          questionnaire allowing the evaluation of persistent stress trauma related to premature~          birth.~        3. An anthropologic study of the utilization of care resources will also be performed~          within the follow-up network taking care of these children.~   "
115588|NCT02054494|"~     HIV-infection is associated with an increased risk for cardiovascular disease. Especially~     patients with low CD4+ counts have a higher incidence of structural heart disease. Myocardial~     T1 relaxation time, as well as T1-derived extracellular volume fraction are relatively new~     methods for non-invasive myocardial tissue characterization, including diffuse myocardial~     fibrosis.~      In our study HIV-patients with high and low CD4+ counts are examined on a 3T MRI scanner~     (Ingenia 3T, Philips Medical, Best, Netherlands). Scanning protocol includes common SSFP~     sequences, STIR imaging and LGE [Late gadolinium enhancement]. All HIV patients are treated~     in the HIV outpatient clinic of the hospital's Internal Medicine department and have an~     unremarkable history of cardiac disease. Patients are recruited from all over Germany. In~     order to obtain reference values, a subgroup of healthy, age-matched controls is included in~     this study.~      Aim of this study is to show differences in T1- and ECV-values in the investigated subgroups.~     In addition, we also want to create cut-off values for healthy and affected myocardium in~     asymptomatic HIV-infected patients. This study could show whether myocardial T1 mapping is a~     potential screening parameter for beginning heart disease as part of an HIV-infection, and~     whether an application in routine diagnostic is reasonable.~   "
115589|NCT02054481|"~     The overall purpose of this trial is to assess clinical efficacy and safety of different~     subcutaneous doses of BI 655066 in adult patients with chronic plaque psoriasis in order to~     select doses for further clinical trials.~   "
132588|NCT01831843|"~     To evaluate differences in intraoperative body temperature between heated huimid breathing~     circuit and conventional breathing circuit~   "
115593|NCT02054429|"~     The purpose of this study is to determine the safety and efficacy of lowering glucose (blood~     sugar), in addition to endovascular therapy, after acute ischemic stroke. The study will~     determine if lowering glucose (blood sugar) in addition to endovascular therapy will improve~     90-day functional and neurological outcomes in comparison to standard glycemic care in~     patients with acute ischemic stroke. The study will involve treatment of 100 (50 intensive~     insulin therapy and 50 standard glycemic control) non-diabetic patients presenting within 8~     hours of acute ischemic stroke who have undergone endovascular therapy.~   "
115594|NCT02054416|"~     In this clinical research study the investigators will test the efficacy of an innovative,~     non-invasive methodology to reduce mortality and lower limb loss among high-risk~     medically-underserved patients with cardiovascular disease in North Philadelphia.~      Patients with cardiovascular disease and recent lower limb amputation will be treated with an~     intermittent compression device on the remaining lower limb to prevent dual amputation.~      The study hypothesis is that the study intervention will protect against further lower~     limb-loss/death and reduce cardiovascular mortality in these patients (one year effect~     against limb-loss/death).~      This study may result in better secondary prevention strategies for disadvantaged urban~     populations as well as the general population.~   "
115595|NCT02054403|"~     Rationale: Primary angle closure glaucoma (PACG) causes high rates of blindness, either by~     means of a painful attack of acute angle closure glaucoma or unnoticed over a period of many~     years. Patients with angle closure are particularly at risk but can be detected during an~     ophthalmological examination and sent for early preventive (laser) intervention. Current~     practice shows that patients at risk of PACG are frequently missed during routine~     examinations. Moreover, new imaging techniques like swept source optical coherence tomography~     (SS-OCT), are emerging with which the angle of the anterior chamber can be imaged in great~     detail with no burden for the patient. These techniques are already used in clinical practice~     and replace and complete part of the ophthalmic examination. However, in Caucasians, it is~     not yet known to what extent angle closure is detected in regular care and can be detected~     with this OCT device. There are few published data concerning angle closure and PACG in~     Caucasians and its characteristics.~      Objective: To quantify the presence of angle closure by gonioscopy in patients at risk of~     angle closure on SS-OCT. Secondary objectives are to quantify the presence of an increased~     intra-ocular pressure during the day or after dark provocation, to quantify morphometric~     details of the anterior chamber, structural changes, and corneal endothelial cells and to~     quantify the functional changes of the visual field.~      Study design: prospective, observational, descriptive study. Study population: Caucasian~     patients, presenting at the outpatient clinic of the University Eye Clinic Maastricht, aged~     40 to 80 years, who are diagnosed with angle closure on SS-OCT.~      Intervention (if applicable): Not applicable. Main study parameters/endpoints: The main study~     parameter is assessment of the anterior chamber angle according to gonioscopy. Secondary~     study parameters are the presence of an increased intra-ocular pressure (IOP) (>21 mmHg)~     during the day or after dark provocation (IOP rise from baseline), morphometric details of~     the anterior chamber, structural changes of the retinal nerve fiber layer, number of corneal~     endothelial cells and functional changes of the visual field Hypothesis: It is hypothesised~     that, based on its resolution and ease of use, SS-OCT is a suitable imaging technique to~     identify patients with or at risk of angle closure. It will be of value as an additional~     diagnostic instrument and may even replace gonioscopy.~   "
115596|NCT02054390|"~     Metabolic syndrome (MS) has been reported as a risk for cardiovascular events. The aim of the~     present cohort study is to investigate whether ACEi therapy reduces the rate of~     periprocedural myocardial injury (PPMI) after elective percutaneous coronary intervention~     (PCI) among patients with metabolic syndrome.~   "
115597|NCT02054377|"~     Cystic fibrosis (CF) is a progressive disease. Symptoms include coughing, poor lung~     ventilation, recurrent infections, poor weight gain, diarrhoea, malnutrition, stress,~     frustration, depression, irritability, worry, insomnia, behavioural issues and missed~     school/work.~      Tai chi, a Chinese form of exercise, uses slow choreographed movements, breathing exercises~     and mindfulness. Research suggests tai chi can improve physical and emotional wellbeing for~     various chronic conditions.~      This study compares methods of teaching tai chi to 70 people with CF, and evaluates the~     effect on symptoms and quality of life. Adults and children with CF will be recruited and~     randomly allocated to an intervention group or a control group. The former will receive 8~     individual face to face sessions of tai chi over a 3 month period and a video and handouts to~     aid home practice. The latter will have routine care for the first 12 weeks, followed by 8~     individual online sessions of tai chi over a 3 month period, and a video and handouts for~     home practice.~      Both groups will be encouraged to practice tai chi at home in the months following the taught~     sessions.~      Questionnaire data on how participants and their carers are coping with CF, any general~     improvements in wellbeing, and differences in other clinical outcomes (medication etc.)will~     be collected. Data will be collected at the beginning and end of the intervention, and at 6~     and 9 months post intervention and differences between the 2 groups compared over time.~      Feedback from on line focus groups will ask about their experiences, feasibility of learning~     and practicing of tai chi, engagement with the process, perceived health impact, and~     experiences of participation.~      It is hoped that the study may show how Tai Chi can help people with CF to maintain their~     health through mindful exercise, and improve troublesome symptoms like sleep and anxiety.~   "
115598|NCT02054364|"~     This study aims to investigate the feasibility of combining Cognitive Remediation Therapy~     (CRT) with Family Based Treatment (FBT) for future use in a randomized clinical trial to~     reduce the risk of adolescents developing persistent Anorexia Nervosa. Participants will be~     randomly assigned to one of two groups: one group will receive FBT and CRT, and the other~     group will receive FBT and art therapy.~   "
115599|NCT02054351|"~     Advanced ovarian cancer is a high medical need indication. Cure is not available to these~     patients and treatment has palliative intent. A proportion of advanced stage ovarian cancer~     expresses substantial levels of Claudin 6 (CLDN6), a carcino-embryonic transmembrane protein,~     which is absent from normal adult human tissue. IMAB027 is a monoclonal antibody that binds~     to CLDN6. Preclinically IMAB027 was shown to inhibit tumor growth and to kill cancer cells by~     antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity. This trial is~     a first-in-human dose escalation and dose finding Phase 1 trial of IMAB027 in patients with~     recurrent advanced ovarian cancer to assess the safety and tolerability, the~     pharmacokinetics, the antitumoral activity and the immunogenicity of IMAB027.~   "
115600|NCT02054338|"~     The combination of vinflunine and gemcitabine in advanced breast cancer in comparison to~     paclitaxel and gemcitabine is based on the following points: the significant antitumour~     activity of vinflunine in metastatic breast cancer (MBC) as single agent after~     anthracycline-taxane exposure and recent phase I study results of the vinflunine plus~     gemcitabine is at least additive and both drugs have a distinct mechanism of action; since~     taxanes have been approved in the adjuvant setting and are widely used in the treatment of~     early breast cancer it is worthwhile to assess new combination chemotherapy regimens as first~     line therapy for metastatic breast cancer.~   "
115601|NCT02054325|"~     It will be done a randomized triple-blind study comparing 0,2% polidocanol versus 75%~     hypertonic glucose of sclerotherapy in lower limbs´ reticular veins. It will be included only~     adult women with reticular veins on the side of the thighs and mild venous insufficiency~     (CEAP 1). The primary endpoint will be efficacy, and secondary will be safety.~   "
116640|NCT02040766|"~     This randomized, double-blind, double-dummy, placebo-controlled, parallel-group, 12-week~     study will evaluate the efficacy and safety of beclomethasone dipropionate (80 or 160~     mcg/day) administered via breath-actuated inhaler (BAI) and metered-dose inhaler (MDI) in~     pediatric patients 4 through 11 years of age with persistent asthma, compared with placebo.~   "
115602|NCT02054312|"~     The investigators proposed a preliminary randomized control trial of Family Based~     Interpersonal Psychotherapy (FB-IPT), a family-based adaptation of Interpersonal~     Psychotherapy for Depressed Adolescents (IPT-A; Mufson et al., 2000). Forty-five~     preadolescent children (ages 8-12) diagnosed with a depressive disorder will be randomized to~     receive a 14-week course of FB-IPT or Client Centered Therapy (CCT), a supportive~     nondirective psychotherapy that closely approximates treatment at usual in community mental~     health clinics. In addition to assessing the feasibility and acceptability of randomization~     and each of the treatment conditions, this project will evaluate the effects of FB-IPT and~     CCT across multiple domains, including symptomatology and psychosocial functioning.~     Preadolescents will be assessed prior to treatment, during treatment (Weeks 3, 7, 11), one~     week post-treatment, and at 3 and 6 months post-treatment to compare changes in depressive~     symptoms, global, social, and family functioning. Data on psychosocial risk factors~     associated with onset and recurrence of preadolescent depression will be collected prior to~     treatment and at specified intervals post-treatment in order to conduct exploratory analyses~     on correlates of positive and negative treatment outcomes for Family Based IPT. This data~     will be used to generate future hypotheses about potential mediators and moderators that will~     be incorporated into an R01 application for an efficacy study of Family Based IPT.~   "
115603|NCT02054299|"~     The purpose of this study is to determine the effect of the organic cation transporter OCT1~     polymorphisms on the pharmacokinetics of several drugs in order to explain efficacy and~     adverse effects.~   "
115604|NCT02054286|"~     The objectives of this Phase I/II trial is to evaluate the safety, tolerability and~     immunogenicity of THV01 compared to placebo in HIV-1 infected patients on HAART (highly~     active antiretroviral therapies).~      THV01 is composed of two vaccines that derived from the HIV (human immunodeficiency virus):~     lentiviral vectors. They are non-replicative and not infectious. They will be injected~     intramuscularly, eight weeks apart. Three doses will be assessed and compared to placebo.~      36 patients will be enrolled. Eligible patients must have an undetectable viral load and must~     be treated by HAART for more than 12 months. They will be randomly allocated to one of the~     study group and will receive the experimental drugs at one of the three doses or a matching~     placebo.~      Their anti-HIV treatment will be alleviated around each experimental drugs' administration to~     enable THV01 efficacy. HAART will be resumed one week after the second injection. 15 weeks~     after resumption, HAART will be interrupted. Patients will then be monitored every 2 weeks~     for CD4+ T cell counts and viral load as well as for thorough assessment of the elicited~     immune response. Stringent anti-HIV treatments resumption criteria have been implemented,~     based on the CD4+ T cell counts and the viral load.~      Statistical analysis will be performed once the last patient has reached his last visit (week~     36 or earlier in case of early termination).~      A long-term follow-up of all enrolled patients will be performed for 5 years post-prime~     administration. This will provide additional data on the safety, on the immune response and~     the potential long-term risks/benefits associated with THV01.~   "
115605|NCT02054273|"~     The objectives of this study is to assess the characteristics and frequency of adenovirus~     conjunctivitis in a population of male and female patients from one year of age who present~     signs and symptoms of acute conjunctivitis.~   "
115606|NCT02054260|"~     The aim of this study is to assess of effect of Surgicel® (Fibrillar) for preventing delayed~     bleeding after endoscopic hemostasis in non-variceal upper gastrointestinal bleeding~   "
115607|NCT02054247|"~     The aim of this placebo-controlled study was to evaluate the effects of pulsed and continuous~     ultrasound treatments combined with splint therapy on patients with mild and moderate~     idiopathic carpal tunnel syndrome~   "
115608|NCT02054234|"~     The objectives of this study is to assess the characteristics and frequency of adenovirus~     conjunctivitis in a population of male and female patients from one year of age who present~     signs and symptoms of acute conjunctivitis.~   "
115609|NCT02054221|"~     Compare the results of reconstruction and mitral valve replacement in the surgical treatment~     of obstructive hypertrophic cardiomyopathy with severe mitral insufficiency.~   "
115610|NCT02054208|"~     This combined phase 1/2a clinical trial is to investigate the safety, dose limiting toxicity~     (DLT), and exploratory efficacy of three repeated intraventricular administrations of~     NEUROSTEM® (human umbilical cord blood-derived mesenchymal stem cells) versus placebo via an~     Ommaya reservoir at 4 week intervals in patients with Alzheimer's disease.~   "
115611|NCT02054195|"~     This study aimed to compare special guided training model with standard procedure on~     insertion technique for post-placental intra uterine device that provides IUD location close~     enough to fundal part of uterus to prevent expulsion~   "
115612|NCT02054182|"~     The purpose of this study is to determine whether vitamin D supplements given to children~     aged 1 month to 5 years, hospitalized with acute lower respiratory tract infection will~     improve symptoms and reduce the duration of hospitalization.~   "
115613|NCT02054169|"~     Delirium is common in older emergency department (ED) patients and often remains~     unrecognized. Existing instruments to detect delirium are often time consuming and therefore~     not feasible in the busy ED setting In this study the investigators tested the feasibility of~     the newly developed modified confusion assessment method (mCAM-ED).~   "
115614|NCT02054156|"~     The purpose of this trial is to compare the effects of treatment with tobramycin solution for~     inhalation (TIS) with and without azithromycin in people with cystic fibrosis (CF) age 6~     months to 18 years who have early isolation of Pseudomonas aeruginosa (Pa) from a respiratory~     culture. Specimens of blood and sputum or throat swabs will be taken during the study along~     with pulmonary function testing. Participants will receive initial treatment with TIS~     followed additional treatment with TIS if quarterly respiratory cultures are positive for Pa~     in addition to either azithromycin or placebo for 18 months.~   "
115658|NCT02053584|"~     The study is performed to evaluate the accuracy of blood glucose level results obtained from~     fingertip using Labstyle Dario Blood Glucose Monitoring System (BGMS) compared to reference~     equipment (YSI 2300 STATPLUS) and to evaluate the ease of use of the Dario Device by the~     lay-person.~      The participants will review the Dario user manual and guide and will be requested to operate~     the Dario BGMS and perform their own glucose blood test, after which they will be asked to~     complete a questionnaire. As reference the participants will be tested by professional~     caregivers both using the Dario BGMS and by YSI 2003.~   "
115615|NCT02054143|"~     Purpose:~        -  The purpose of this study is to examine the effect of different carbon-dioxide~          concentrations on cerebral CO2 sensitivity and the resistance and stiffness of systemic~          arteries during anesthesia with sevoflurane. Sevoflurane is a widely and commonly used~          inhalational anaesthetic, that is mainly used for the maintenance of general anesthesia.~        -  Changes in the velocity of cerebral blood flow and arterial stiffness due to the~          different exhaled carbon-dioxide concentrations will allow us to conclude how~          sevoflurane affects these parameters during the course of the narcosis.~      Instruments:~        -  An ultrasound device called transcranial doppler (TCD) is used to measure the velocity~          of blood flow within a main artery located inside the skull.~        -  A tonometry device named SphygmoCor is used to assess the pressure wave proceeding in~          the radial artery, from which the stiffness of the systemic vessels can be concluded.~      Measurements:~      - Examinations with the ultrasound and tonometry devices are carried out once before the~     operation, three times during the intervention, with different exhaled CO2 values and once~     after the operation is completed.~      Hypothesis:~      - Sevoflurane alters cerebral carbon-dioxide sensitivity and the stiffness of systemic~     arteries.~   "
115616|NCT02054130|"~     The primary objective of the study is to evaluate the effect of 3 dose levels of MEDI9929~     (AMG 157) on asthma exacerbations in adult subjects with inadequately controlled, severe~     asthma.~   "
115617|NCT02054117|"~     Intracerebral hemorrhage is bleeding into the brain and is a major cause of stroke and other~     complications. Brain injury from intracerebral hemorrhage occurs in two phases. The early~     phase involves the mechanical compression of brain tissue by the expanding hematoma. In a~     later phase, brain swelling develops causing further compression that may lead to brain~     herniation and death. This study investigates the neuroprotective role of haptoglobin, in~     minimizing the development of brain swelling following intracerebral hemorrhage.~   "
115618|NCT02054104|"~     Background:~      During recent years, cancer-testis (CT) antigens (CTA), particularly those encoded by genes~     on the X chromosome (CT-X genes), have emerged as attractive targets for cancer~     immunotherapy. Whereas malignancies of diverse histologies express a variety of CTAs, immune~     responses to these proteins appear uncommon in cancer patients, possibly due to low-level,~     heterogeneous antigen expression, as well as immunosuppressive regulatory T cells present~     within tumor sites and systemic circulation of these individuals. Conceivably, vaccination of~     cancer patients with tumor cells expressing high levels of CTAs in combination with regimens~     that deplete or inhibit T regulatory cells will induce broad immunity to these antigens. In~     order to examine this issue, patients with primary lung and esophageal cancers, pleural~     mesotheliomas, thoracic sarcomas, thymic neoplasms and mediastinal germ cell tumors, as well~     as sarcomas, melanomas, germ cell tumors, or epithelial malignancies metastatic to lungs,~     pleura or mediastinum with no evidence of disease (NED) or minimal residual disease (MRD)~     following standard multidisciplinary therapy will be vaccinated with H1299 tumor cell lysates~     with Iscomatrix adjuvant. Vaccines will be administered with or without metronomic oral~     cyclophosphamide (50 mg PO BID x 7d q 14d), and celecoxib (400 mg PO BID). Serologic~     responses to a variety of recombinant CTAs as well as immunologic responses to autologous~     tumor or epigenetically modified autologous EBVtransformed lymphocytes will be assessed~     before and after a six month vaccination period.~      Primary Objectives:~      1. To assess the frequency of immunologic responses to CTAs in patients with thoracic~     malignancies following vaccinations with H1299 cell lysate/Iscomatrix(TM) vaccines alone in~     comparison to patients with thoracic malignancies following vaccinations with H1299 cell~     lysate/Iscomatrix vaccines in combination with metronomic cyclophosphamide and celecoxib.~      Secondary Objectives:~        1. To examine if oral metronomic cyclophosphamide and celecoxib therapy diminishes the~          number and percentage of T regulatory cells and diminishes activity of these cells in~          patients with thoracic malignancies are at risk of recurrence.~        2. To examine if H1299 cell lysate/Iscomatrix(TM) vaccination enhances immunologic response~          to autologous tumor or epigenetically modified autologous EBV-transformed lymphocytes (B~          cells).~      Eligibility:~        -  Patients with histologically or cytologically proven small cell or non-small cell lung~          cancer (SCLC;NSCLC), esophageal cancer (EsC), malignant pleural mesothelioma (MPM) ,~          thymic or mediastinal germ cell tumors, thoracic sarcomas, or melanomas, sarcomas, or~          epithelial malignancies metastatic to lungs, pleura or mediastinum who have no clinical~          evidence of active disease (NED), or minimal residual disease (MRD) not readily~          accessible by non-invasive biopsy or resection/radiation following standard therapy~          completed within the past 26 weeks.~        -  Patients must be 18 years or older with an ECOG performance status of 0 2.~        -  Patients must have adequate bone marrow, kidney, liver, lung and cardiac function.~        -  Patients may not be on systemic immunosuppressive medications at time vaccinations~          commence~      Design:~        -  Following recovery from surgery, chemotherapy, or chemo/XRT, patients with NED or MRD~          will be vaccinated via IM injection with H1299 cell lysates and Iscomatrix(TM) adjuvant~          monthly for 6 months.~        -  Vaccines will be administered with or without with metronomic oral cyclophosphamide and~          celecoxib.~        -  Systemic toxicities and immunologic response to therapy will be recorded. Pre and post~          vaccination serologic and cell mediated responses to a standard panel of CT antigens as~          well as autologous tumor cells (if available) and EBV-transformed lymphocytes will be~          assessed before and after vaccination.~        -  Numbers/percentages and function of T regulatory cells in peripheral blood will be~          assessed before, during, and after vaccinations.~        -  Patients will be followed in the clinic with routine staging scans until disease~          recurrence.~        -  The trial will randomize 28 evaluable patients per arm to either receive vaccine alone~          or vaccine plus chemotherapy in order to have 80% power to determine if the frequency of~          immune responses on the combination arm exceeds that of the vaccine alone arm, if the~          expected frequencies of immune responses on the two arms were 20% and 50%, using a~          one-sided 0.10 alpha level Fisher s exact test.~        -  Approximately 60 patients will be accrued to this trial.~   "
115619|NCT02054091|"~     Feeding preterm infants is of great challenge in the NICUs. Mother's own milk is considered~     as the best for the digestive system followed by donor milk. Preterm infant formula is~     related to more feeding problems and other gut complications in these babies, such as~     necrotizing enterocolitis. Bovine colostrum contains higher amounts of protein, growth~     factors and immuno-regulatory components (e.g. immunoglobulins), which has been used in many~     other situations to promote health. The investigators plan to give bovine colostrum to~     preterm infants with birth weights between 1000 and 1800 g, or born between 27+0 and 32+6~     weeks of gestational age, in order to promote feeding and intestinal health in these babies.~     This current study is a feasibility pilot study and the investigators hypothesized that~     supplementing BC to MM (if available) is safe and tolerable when used within the first 10-14~     days of life in preterm infants.~   "
115620|NCT02054078|"~     Patients with Malignant pleural effusion can be diagnosis advanced cancer. Currently~     recognized as the most reliable method to control malignant pleural effusion is pleural fixed~     or thoracic catheter drainage. The most effective pleural fixed agent is pulvis talci, but~     there are about 30% relapse rate. Thoracic drainage can lead to some complications, such as~     chest infections, catheter migration and blockage etc. The investigators need a reliable~     methods to solve dyspnea and other symptoms caused by malignant pleural effusion, and improve~     quality of life. The purpose of this study was to determine the efficacy and Safety of~     intrapleural Bevacizumab versus pulvis talci as treatment for malignant pleural effusions~     (MPE) in patients.~   "
115621|NCT02054065|"~     This study proposes to expand upon previous research by studying the effects of a~     urinary-catheter removal alert on duration of urinary catheter use and frequency of CAUTIs~     with a large, randomized controlled trial within a three-hospital academic medical center.~      Hypothesis The proposed urinary-catheter removal alerts will decrease the number of catheter~     days and decrease the number of catheter associated urinary tract infections (CAUTIs), but~     will not affect the catheter re-insertion rate.~   "
115622|NCT02054052|"~     Malignant pleural or pericardial effusion is common in lung cancer, and intrapleural drugs~     injection is important in the treatment. Non- cytotoxic drugs include those with a sclerosing~     effect that produces pleurodesis, which is easy to cause severe chest pain despite of no~     influence on the following chemotherapy. Tumor angiogenesis is important in producing MPE.~     Bevacizumab has been administrated locally in treating optic nerve sickness successfully by~     anti-VEGF mechanism. So we hypothesize that intrapleural bevacizumab is also effective in~     treating MPE.~   "
115623|NCT02054039|"~     - Postoperative pulmonary complications in patients undergoing cardiac surgery are a major~     clinical problem, presenting negative impact on morbidity, mortality , length of hospital~     stay and health care costs. Although physical therapy has been widely used as a resource to~     improve lung function in the postoperative period, the adoption of routine procedures of~     physical therapy needs be discussed.~        -  Incentive spirometers are mechanical devices used to reduce postoperative pulmonary~          complications. In general, they are activated by an inspiratory effort, visualized by an~          uplifted plate or ball in a transparent cylinder during sustained inspiration.~        -  Breath Stacking is a technique allowing the patient inhale a greater volume of air, kept~          for a longer period of time using a one-way valve, thus promoting the accumulation of~          successive inspiratory volume and preventing exhalation.~        -  The objective of the study is to evaluate the effectiveness of two different techniques~          of respiratory therapy on both reducing postoperative pulmonary complications and~          improving lung function.~        -  Type of study : randomized clinical trial~        -  Hypothesis~             1. Both techniques Trifllo II Incentive Spirometry ( IS) (Trifllo ® - II ) and Breath~               Stacking ( BS ) may present similar effectiveness on reducing pulmonary~               complications, improving lung function and respiratory muscle strength ( MIP and~               MEP), as well as reducing hospital stay .~             2. Trifllo II Incentive Spirometry ( IS) (Trifllo ® - II ) may be more effective than~               Breath Stacking on reducing pulmonary complications, improving lung function and~               respiratory muscle strength, as well as reducing hospital stay.~   "
115624|NCT02054026|"~     The purpose of this study is to evaluate the effectiveness of an eight-hour version of~     Reducing the Risk on outcomes such as sexual initiation, condom and contraceptive use, number~     of sexual partners, and pregnancy.~   "
116663|NCT02040467|"~     The goal is to collect information on each patient treated with proton beam radiation~     therapy.~   "
115625|NCT02054013|"~     Benign prostatic hyperplasia (BPH) is a prevalent entity, affecting over 50% of men older~     than 60 years. The clinical picture of the disease includes lower urinary tract symptoms such~     as interrupted and weak urinary stream, nocturia, urgency and leaking and even sexual~     dysfunction in some individuals. Medical therapy is usually the first-line treatment.~     However, the efficacy of drugs like alpha-blockers is limited, and as disease progresses more~     invasive treatment options have to be taken into consideration. In cases with moderate to~     severe lower urinary tract symptoms (LUTS) transurethral resection of the prostate (TUR-P) is~     the standard treatment. TURP, however, is limited to prostates smaller than 60-80ml and the~     procedure is associated with a complication rate. The cumulative short-term morbidity rate is~     around 11% and the necessity for surgical revision is as high as 6%. Bleeding requiring~     transfusions and transurethral resection syndrome represent potentially serious threats to~     elderly and frail patients. Prostatic artery embolization (PAE) has been suggested as a~     minimal invasive alternative procedure, which can be performed in an outpatient setting with~     rapid recovery and low morbidity.~      The investigators hypothesize that PAE is non-inferior in the treatment of symptomatic BPH~     compared to conventional and established TUR-P.~   "
115626|NCT02054000|"~     The goal of this study was to evaluate the acute effect of intracoronary administration of~     tirofiban on no-reflow phenomenon in patients with STEMI and occurrence of no-reflow~     phenomenon undergoing primary percutaneous coronary intervention (PCI).~   "
115627|NCT02053987|"~     An Early Supported Discharge (ESD) service for stroke is an evidence based intervention that~     aims to enable a particular group of patients who have a mild to moderate stroke to be~     discharged from hospital early and receive the same intensity of rehabilitation in their~     home. Analysis of almost 1600 patients has demonstrated that ESD can reduce long term~     dependency, decrease admission to institutionalized care as well as shorten hospital stay.~     This model has also been shown to reduce death and institutionalized care at five years~     (Fjaetoft et al, 2011) and has been shown to be cost effective (Saka, 2005.) A study by~     National Heath Service (NHS) London showed that patient outcomes has not been affected by~     being treated at home and that there have not been an increase in readmissions due to the~     setting up of an ESD service.~      However, those with moderate to severe strokes are often not eligible for ESD rehabilitation.~      This study aims to offer twenty Camden residents an Enhanced Early Supported Discharge~     service in which stroke survivors with moderate to severe impairments are eligible.~     Participants will be recruited from the University College London Hospital (UCLH)l Hyper~     Acute Stroke Unit and acute stroke units at UCLH and the Royal Free Hospital.~      This study will compare health and economic outcomes of early Multidisciplinary stroke~     rehabilitation in the community compared to traditional inpatient and community~     Multidisciplinary rehabilitation for people with moderate to severe post stroke impairments.~      We will also collect the views of the participants and their carers regarding being treated~     at home.~      The objectives are to discover:~        1. What impact does the implementation of an Enhanced ESD service for stroke survivors with~          moderate to severe impairments have on clinical and cost outcomes compared to an~          unchanged care pathway in a neighbouring borough?~        2. What are the staff, participant and carer views and experiences of an Enhanced ESD~          service?~   "
115628|NCT02053974|"~     This study sought to investigate the whether spironolactone protects the heart against~     anthracycline-induced cardiotoxicity.~   "
115629|NCT02053961|"~     The study is a double-blind study designed to evaluate the efficacy of deep transcranial~     magnetic stimulation (deep TMS) of the left auditory cortex using the HMCIPCC coil, in the~     treatment of patients with tinnitus~   "
115630|NCT02053948|"~     The use of temporary stomas has been demonstrated to reduce septic complications after~     colorectal cancer surgery, especially in high-risk anastomosis; therefore, it is necessary to~     reduce the number of complications secondary to ostomy takedowns, namely wound infection. The~     aim of this study is to compare the rates of superficial wound infection, healing time and~     patient satisfaction after pursestring closure vs gunsight skin incision and closure~     technique closure.~   "
115631|NCT02053935|"~     This is a clinical study of a drug named dopamine and how it affects our bodies ability to~     make and secrete insulin. Insulin is a hormone made in the pancreas that helps our body~     regulate sugar levels. We think that this drug decreases the amount of insulin our body makes~     and causes our sugar levels to be high. When you are critically ill there can be many adverse~     effects if you have sugar levels that are too high.~   "
115632|NCT02053922|"~     The use of Oxytocin, Carbetocin and buccal misoprostol in patients undergoing elective~     Cesarean Section~   "
115633|NCT02053909|"~     Saphenous vein graft disease remains an unresolved medical problem. Many vein grafts occlude~     in the first year after bypass surgery, leading to adverse cardiovascular outcomes, including~     recurrent angina, myocardial infarction, and the need for repeat coronary intervention. While~     aspirin is the standard antiplatelet treatment after CABG surgery, 10-20% of vein grafts~     continue to occlude despite contemporary secondary preventative therapy. Compared to aspirin~     and other antiplatelet therapies like clopidogrel, ticagrelor treatment leads to a more~     pronounced platelet inhibition, and may substantially improve graft patency following CABG~     compared to aspirin. No data has yet to be collected regarding the impact of ticagrelor on~     saphenous vein graft patency following CABG. In this context, the investigators seek to~     compare vein graft patency between patients randomized to receive aspirin therapy, the~     current standard of care, or ticagrelor treatment, starting in the early postoperative~     period, and continuing for 2 years after CABG.~   "
115634|NCT02053896|"~     The purpose of this study is to evaluate the safety and efficacy of ISU302 in patients with~     Type 1 Gaucher disease previously treated with Imiglucerase.~   "
115635|NCT02053883|"~     This is a multicenter, randomized, double-blind, placebo-controlled Phase IIb/III study~     designed to evaluate the efficacy and safety of Cethrin as a treatment for acute cervical~     spinal cord injury. During the trial, high and low doses of Cethrin will be compared with~     placebo.~   "
115636|NCT02053870|"~     This study aims to assess the responsiveness to change of adventitious lung sounds (ALS) in~     patients with lower respiratory tract infection (LRTI).~      Patients will be recruited from a central Hospital and their demographic and anthropometric~     data, lung sounds, lung function, breathlessness, oxygen saturation and chest HRCT scan will~     be collected within 24h of the first appointment. Then, patients will be randomly allocated~     to either conventional treatment or conventional treatment plus respiratory physiotherapy.~     Conventional treatment will consist on daily medical treatment prescribed by the physician.~     Respiratory physiotherapy will involve 9 sessions (3 times a week during 2 weeks) of~     breathing retraining and chest clearance techniques, exercises for thoracic mobility,~     expansion and flexibility, cardiorespiratory exercise training and education about the~     disease.~      It is expected that ALS will be responsive to changes in patients' lung function after~     treatment. It is also expected that, by including a respiratory physiotherapy component in~     the treatment of patients with LRTI, they will express more improvements in a shorter period~     of time.~   "
115638|NCT02053844|"~     This project aims to assess the impact of a web-based health care cost and quality tool that~     is being implemented by a health plan for its members. The study will focus on members~     working for medium to large employers that have more than 90% of employees enrolled in~     deductible and tiered network health plans. The study will use an interrupted time series~     (ITS) design that includes random allocation of half of these employers to a study arm that~     will receive enhanced promotion of the tool and a $500 lottery incentive for its use in order~     to increase take-up. With these two study groups (a high-dose group receiving enhanced~     promotion and a lottery, and a low-dose group receiving routine promotion of the tool), the~     study will be able to evaluate whether access to a price transparency tool leads to reduced~     costs and more value-driven member behavior, and whether extra promotion increases take-up.~      Members in the high-dose group who use the tool will be eligible to enter a monthly lottery~     to win a $500 prize during the 12-month intervention period. In addition to the lottery,~     employers in the high-dose group will receive additional promotional strategies such as a~     mailing and messages through the plan's member web portal to promote the tool and the~     lottery, and e-mails and flyers for employers to promote the tool and lottery to employees.~      The aims of this project are to: 1) examine take-up of the tool and factors that predict~     take-up; and 2) to examine the impact of the tool on total and out-of-pocket health care~     costs and utilization~   "
115639|NCT02053831|"~     In this post market study a resorbable mesh (GalaFLEX) will be used to reinforce the lifted~     and imbricated SMAS along the suture lines and spread the load of the SMAS along a greater~     surface area. GalaFLEX mesh is comprised of resorbable 4-hydroxybutyrate fibers.~   "
115640|NCT02053818|"~     To evaluate the effect on cognitive function, recovery, cardioprotection and haemodynamics of~     standard Remifentanil anaesthesia to standard Sufentanil anaesthesia in patients undergoing~     coronary artery bypass with or without aortic valve replacement.~   "
115641|NCT02053805|"~     This will be a prospective diagnostic trial of screening for prostate cancer among men with~     genetic predisposition.~   "
115642|NCT02053792|"~     This study will examine the long-term safety and efficacy of rIX-FP for the control and~     prevention of bleeding episodes in children and adults with severe hemophilia B. The study~     will include subjects who have not previously been treated with Factor IX products, subjects~     who previously completed a CSL-sponsored rIX-FP lead-in study and subjects requiring major~     non-emergency surgery who have not previously completed a CSL-sponsored rIX-FP lead-in study.~      A surgical prophylaxis substudy will examine the efficacy of rIX-FP in subjects with~     hemophilia B who are undergoing non-emergency major or minor surgery. An additional substudy~     will examine the safety and PK of subcutaneous (SC) administration of rIX-FP.~   "
115643|NCT02053779|"~     Purpose:The aim of this project is to prospectively determine whether a single dose of~     GnRH-agonist administered at the time of implantation increases or not the reproductive~     outcome in patients undergoing in vitro fertilization ( IVF)/ intracytoplasmatic sperm~     injection(ICSI) triggered by a GnRH-agonist followed by a small bolus of human chorionic~     gonadotropin (hCG 1500 IU) the day of oocyte retrieval.~      Acronyms:~      GnRH: gonadotropin-releasing hormone FSH: follicle stimulating hormone LH: luteinizing~     hormone HCG:human chorionic gonadotropin IVF:In vitro fertilization ICSI:intracytoplasmatic~     sperm injection OHSS:ovarian hyperstimulation syndrome OMEGA: oocyte maturation employing~     GnRH-agonist OPU: ovum pick up NaCl: sodium chloride~   "
115644|NCT02053766|"~     This pilot study is a prospective, randomized clinical trial to evaluate the effect of~     anesthesia in the mitochondrial dysfunction patient.~   "
115645|NCT02053753|"~     To evaluate the bioequivalence based on pharmacokinetics (PK) of a single 120 mg subcutaneous~     dose of denosumab administered to healthy volunteers using denosumab CP4 or denosumab CP2~     drug products.~   "
115646|NCT02053740|"~     Participants and study design:~      Subjects were recruited and selected for uremic patients on maintenance hemodialysis (HD) who~     informed us of their interest in the investigators study and were mentally capable to give an~     informed written consent and willing to comply with study requirements. The inclusion~     criteria were 18 years or older, with at least 3 months maintenance HD. The exclusion~     criteria were malignancy, acute infection, gastrointestinal bleeding, pregnancy, and~     inability to comply with the requirements of study.~      69 respondents were enrolled in this trial. A single-center quasi-randomized controlled~     clinical trial was designed based on the patients in the care of one attending physician.~     Eligible subjects were allocated to study and control group, and the basic characteristics~     between the experimental group and control group were matched. There was no significant~     difference regarding gender, aged, education level, comorbidities between these two groups.~     The experimental group was treated with Ren Shen Yang Rong Tang (R-S-Y-R-T) combined routine~     western medicine, and the control group was treated with WM alone. The experimental group had~     32 respondents and the control group had 37 respondents. The duration of use of R-S-Y-R-T was~     6 months. Finally, there were 27 patients in the experimental group and 32 patients in the~     control group completed the study. Blood investigation, including biochemical profiles and~     inflammatory markers were checked at intervals 0, 2, 4 and 6 months form routine HD. The~     questionnaire, for the assessment of quality of life (QOL) was evaluated at interval 0, and 6~     months.~   "
115647|NCT02053727|"~     The purpose of this study is to investigate whether the combination of abatacept along with~     entecavir (the study drugs) is safe and effective in treating symptoms related to rheumatoid~     arthritis (RA).~      Abatacept, given in an intravenous (IV - injected into a vein) as well as subcutaneous form,~     is approved by the FDA for the treatment of RA. In this research, abatacept will be given by~     injection. A subcutaneous injection is an injection given under the skin.~      Entecavir, to be taken by mouth, is approved by the FDA for the treatment of hepatitis B.~      The study is divided into the following time periods:~      Screening Phase: Up to 4 weeks Randomized Double-blind Phase: 24 weeks Open-label Extension~     Phase: 24 weeksFollow-up Phase: a phone call after Week 48~      Each phase contains one or more study visits.~   "
116099|NCT02047825|"~     Multiple sclerosis is a chronic and highly disabling disorder with considerable social impact~     and economic consequences. It is caused by damage to the myelin sheath, the protective~     covering that surrounds nerve cells. Different areas are affected, including manual~     dexterity, strength, coordination and function. The objective of this study is to evaluate~     the improvement in these variables in patients with multiple sclerosis after a 8-weeks~     intervention focused on upper limbs.~   "
115648|NCT02053714|"~     Persons with severe mental illness are at great risk for developing type 2 diabetes (T2DM).~     Unfortunately, persons with mental illness and T2DM are less likely to receive recommended~     diabetes monitoring and are more likely to have poorly controlled diabetes, which leads to~     microvascular and macrovascular complications later in life. Evidence-based diabetes~     self-management education and support interventions have yet to be adapted for persons with~     mental illness and there have been no randomized controlled trials (RCTs) to examine their~     feasibility and efficacy. The purpose of this study is to assess the feasibility of~     conducting a RCT of a diabetes self-management intervention for persons with severe mental~     illness and T2DM.~   "
115649|NCT02053701|"~     Magnetic resonance spectroscopy (MRS) allows non-invasive measurement of the concentration of~     up to 18 metabolites in the brain (neurochemical profile).~      The objective of this proposal is to develop new methods for high-field brain MRS (3 to 7~     Tesla).~      Our main hypothesis is that higher magnetic fields lead to improved spatial and temporal~     resolution and improved quantification precision.~      Aims~        1. To obtain improved neurochemical profiles in the brain using single voxel proton MRS~          at very high field (3 Tesla to 7 Tesla).~        2. To develop new methods for proton magnetic resonance spectroscopic imaging (MRSI) to~          obtain metabolic maps at very high field (3 Tesla to 7 Tesla).~      Since this project is focused on technical development, only healthy volunteers will be~     recruited (no patients).~   "
115650|NCT02053688|"~     The objective of this study is to evaluate the fitting and visual outcomes of Nexis Lens,~     made of silicone commonly used in the contact lens industry, on healthy eye with or without~     astigmatism.~   "
115651|NCT02053675|"~     Vasopressin is a vasopressor used in patients with septic shock. However, its systemic~     hemodynamic effects and its microcirculation effects are not completely known and understood.~     This study aimed to evaluate the effect of exogenous vasopressin on sublingual~     microcirculation using the sidestream dark field technique and to correlate it with its~     systemic effects. To this prospective interventional study, patients with septic shock were~     included during the first 48 hours of use of catecholamine vasopressors, admitted to the~     intensive care unit of a university hospital. Vasopressin was administered at 0.04 U / min~     for one hour. Systemic hemodynamic measurements were obtained immediately before and 1 hour~     after vasopressin. In addition, images of sublingual microcirculation were collected through~     sidestream dark field technology. Further analysis with specific software was done after.~   "
115652|NCT02053662|"~     To develop a simple blood and urine test that we would perform before patients start their~     treatment to predict the risk that their bladder cancer might come back. To develop this test~     the investigators plan to analyze blood, urine and cancer tissue from bladder cancer patients~     and follow them closely during and after treatment. This will include looking for changes in~     proteins and genes that might play a role in bladder cancer biology. The investigators will~     then compare the information obtained from the studies of blood, urine and cancer tissue~     between patients that are cured and those whose cancer comes back. The knowledge about these~     differences between patients can then potentially be used to develop a blood or urine test to~     tell us who has a high risk for having bladder cancer come back.~   "
115653|NCT02053649|"~     Perinatal depression is a common and serious mood disorder that increases morbidity and~     mortality in new mothers and results in poor infant/child outcomes. Current therapies often~     fail to produce recovery or are poorly tolerated and many pregnant women seek~     non-pharmacologic therapy or forgo treatment when non-pharmacologic options are not~     available. Expectant and new mothers who suffer from circadian rhythm disruption are at risk~     for perinatal depression. This R34 Pilot Effectiveness Studies and Services Research Grant~     seeks to test whether an Integrated Chronotherapy (IC) intervention can be implemented in an~     outpatient psychiatry setting to improve treatment outcomes for patients with perinatal~     depression. IC is a multicomponent treatment consisting of bright light therapy, sleep phase~     advance, and sleep stabilization/restriction that targets the Research Domain Criteria (RDoC)~     constructs of circadian rhythms, sleep-wake behavior, social rhythms, and arousal. We will~     assess the feasibility, safety, and acceptability of an IC intervention for perinatal~     depressin by testing the treatment in expectant mothers diagnosed with major depressive~     disorder during 3rd trimester of pregnancy. We will randomize patients to either: (a) usual~     care (UC, n = 20) or (b) IC+UC (n = 20). IC+UC will have pregnancy and postpartum components~     and will be administered via an individualized case formulation approach tailored to each~     patient. After a baseline assessment, IC will be prescribed during 5 dedicated clinical~     visits: three during 3rd trimester of pregnancy and 2 in the postpartum period. UC will~     consist of medication administered by a perinatal psychiatrist and/or psychotherapy. UC will~     be quantified in both groups to evaluate differences between the IC+UC and UC groups. Mood~     will be measured in both groups by blinded clinician interview and patient self-report. We~     will assess the safety profile of the IC intervention with evaluation of side effects/adverse~     events. Importantly, the study will also examine the putative mechanisms by which IC is~     hypothesized to work and the dose of IC received by patients in the IC+UC group. All~     participants will wear wrist actigraphy/light monitors continuously during weeks 28-40 of~     pregnancy and postpartum weeks 2-6 to assess light exposure and sleep duration and timing.~     Circadian phase (measured with salivary dim light melatonin onset) will be measured at~     baseline during pregnancy (~30 weeks gestation), at 36 weeks gestation, and at postpartum~     week 6. This pilot will allow us to refine the IC intervention for future integration into~     various clinical settings and establish an infrastructue for a larger (R01-scale) trial,~     including measuring acceptability of IC among UC clinicians and implementing web-based data~     collection to facilitate data sharing in the planned R01. Perinatal IC could have major~     public health impact due to the high prevalence of perinatal depression and its negative~     effects on mothers and their children. This project represents a first step toward achieving~     this goal, as it will provide the pilot data necessary to prepare for a larger scale~     intervention study focused on providing non-pharmacologic therapies and improving outcomes~     for women with perinatal depression.~   "
115654|NCT02053636|"~     The aim of the study is to evaluate the objective response rate (ORR) of single agent~     lucitanib in metastatic breast cancer patients with FGFR1-amplified, FGFR1-non amplified with~     11q amplification, or FGFR1-non amplified without 11q amplification.~   "
115655|NCT02053623|"~     Approximately one billion people suffer from hypertension worldwide. At least 10% of this~     population, that is, 100 million people, also suffers from associated chronic conditions~     namely, atrial fibrillation (AF), obesity, arterial stiffness (AS), and heart failure (HF).~     Personal interaction with medical practitioners (doctors) and review of published clinical~     research confirms that current non-invasive automatic blood pressure (BP) monitors that rely~     on BP pulse analysis alone cannot provide accurate measurement due to the unpredictable/weak~     nature of BP pulses in the above-mentioned chronic conditions. Lack of accuracy in BP~     estimation can lead to wrong diagnoses and hence to complications such as stokes and heart~     attacks.~      The Sponsor is developing a novel non-invasive BP monitor that is similar to existing~     automatic monitors yet is capable of acquiring and analyzing electrocardiogram (ECG) data in~     conjunction with BP pulse data to provide better and more accurate measurements in the above~     chronic conditions.~      The objective of this clinical trial is to evaluate the performance of this ECG-assisted BP~     monitor against invasive BP measurements in a small group of patients who suffer from the~     above conditions.~   "
115656|NCT02053610|"~     This open-label, randomized, 3-arm study will evaluate the efficacy and safety of~     (obinutuzumab) RO5072759 in combination with chlorambucil as compared to rituximab plus~     chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic~     leukemia (CLL). Patients will be randomized 2:2:1 to receive a maximum of six 28-day cycles~     of either RO5072759 (1000 mg intravenous (iv) infusion, on days 1, 8 and 15 of cycle 1 and~     day 1 of cycles 2-6) plus chlorambucil (0.5 mg/kg orally, days 1 and 15 of cycles 1-6), or~     rituximab (iv infusion day 1, 375 mg/m^2 cycle 1, 500 mg/m^2 cycles 2-6) plus chlorambucil,~     or chlorambucil alone. Anticipated time on study treatment is >6 months and follow-up for~     disease-progression and safety will be at least 5 years. In the US, this trial is~     sponsored/managed by Genentech.~   "
115657|NCT02053597|"~     Recently, there has been a rising trend of delaying childbearing and hence more women are~     diagnosed with breast cancer before completing their families. Given the continuous decline~     in recurrences and death secondary to breast cancer and the reassuring data on the safety of~     pregnancy following breast cancer more women are inquiring into the possibility of preserving~     fertility following chemotherapy. The challenge remains in using a regimen that is devoid of~     cyclophosphamide, but is as effective as the standard regimens that incorporate~     cyclophosphamide. The combination doxorubicin (50 mg/m2) and paclitaxel (200 mg/m2) (AP)~     followed by 12 weeks of paclitaxel (80 mg/m2) (P) emerges as a treatment option with~     convincing results regarding its effectiveness in the early setting, and could be potentially~     associated with less ovarian toxicity being devoid of cyclophosphamide.~   "
116937|NCT02036905|"~     The objective of this pilot study is to determine the feasibility of a large-scale trial. The~     primary objective is to determine if manipulation applied to the cervical and thoracic spines~     is more effective than mobilization applied to the cervical and thoracic spines for the~     management of patients with mechanical neck pain.~   "
115659|NCT02053571|"~     The goal of this study is to evaluate an alternate approach, which involves using a 3D~     puncture path overlay, to access the portal vein during a Transjugular Intrahepatic~     Portosystemic Shunt (TIPS) procedure. The study should determine if the alternate approach~     provides these benefits: improved safety of procedure, and reduced intervention time~     (including reduction of radiation exposure), which benefits both interventional radiologist~     and the patient.~      During a TIPS procedure, a shunt or stent (mesh tube) is passed down the jugular vein (the~     vein above the collarbone in the neck) using fluoroscopy (x-ray) guidance. The shunt then is~     inserted between the portal vein (vein that carries blood from the digestive organs into the~     liver) to a hepatic vein (vein that carries blood away from the liver back to the heart).~      In the standard approach, the interventional radiologist uses two-dimensional guidance (2D -~     having the dimensions of height and width only) to locate the path between the portal vein~     and hepatic vein. However, since these two veins do not connect, this method does not provide~     information on the three-dimensional (3D) relationship between the two veins.~      In the alternate approach, the physician will have the option of using 3D guidance to locate~     the path. An on-table limited (small field of view) CT scan, used in combination with FDA~     approved imaging software, will provide a 3D image demonstrating the relationship between the~     portal vein and the hepatic vein. The 3D image is overlaid on the standard live x-ray images~     to assist in needle guidance during the TIPS procedure.~      The CT scan performed will be in place of the angiograms that are typically performed.~     However, if the portal vein is not adequately seen in the CT images, the angiograms will be~     done and there will be no overlay. The procedure will proceed using the standard approach.~   "
115660|NCT02053558|"~     It has been demonstrated that female patients have poor quality of surgical recovery compared~     to male patients. Increased sensitivity to pain and increased susceptibility to postoperative~     nausea and vomiting have been attributed as causal factors. Currently, few strategies have~     been shown to improve quality of recovery in female patients undergoing laparoscopic~     hysterectomy. A better recovery in female patients undergoing outpatient laparoscopy is~     particularly desirable since those patients do not have access to potent intravenous~     medications and nursing support after hospital discharge.~      Our group has previously demonstrated that both TAP block and systemic lidocaine improve~     quality of recovery after outpatient laparoscopic gynecological surgery. The TAP block,~     however, requires expertise, equipment (ultrasound), and additional time to perform as~     compared with a simple lidocaine infusion. It is currently unknown if a systemic lidocaine~     infusion provides non-inferior quality of recovery when compared to TAP block for outpatient~     laparoscopic gynecological surgery.~      The main objective of the current investigation is to examine the effect of TAP block on~     quality of recovery compared to a systemic lidocaine infusion. We hypothesize that systemic~     lidocaine infusion would provide non-inferior quality of recovery when compared to TAP block~     for outpatient laparoscopic gynecological surgery.~      Significance: This is the first study to compare systemic lidocaine to TAP block with regard~     to quality of recovery.~      The research question; does systemic lidocaine provide similar quality of recovery as TAP~     block for outpatient laparoscopy? The hypothesis; systemic lidocaine provides non-inferior~     quality of recovery as TAP block for outpatient laparoscopy.~      Research significance: It has been shown that females have poor surgical recovery compared to~     males; this project intends to demonstrate that systemic lidocaine provides similar recovery~     as TAP blocks but it does not require the expertise, equipment, and time needed to perform~     TAP blocks.~   "
115661|NCT02053545|"~     Although a majority of children with leukemia and most hematological malignancies (Hodgkin's~     and Non-Hodgkin's lymphomas) can be cured with conventional chemotherapy, a subset of~     patients with resistant/recurrent high-risk disease are not cured with conventional treatment~     regimens. Investigators hypothesize that HSCT from a partially matched donor can be safe and~     effective for patients with very high risk hematologic malignancies when combined with~     post-transplant cyclophosphamide for prevention of graft-vs-host disease (GVHD).~   "
115662|NCT02053532|"~     Patients with post-traumatic stress disorder (PTSD) have abnormalities in the function of the~     amygdala and medial prefrontal cortex (particularly anterior cingulate), in addition to~     abnormalities of hippocampal volume. In this pilot study we propose to use the combined~     positron emission tomography/magnetic resonance (PET/MR) scanner and F-18-fluorodeoxyglucose~     (FDG, an analog of glucose, the most commonly used PET ligand) to examine brain function and~     directly correlate the data with the intrinsic functional connectivity of brain circuits that~     are responsible for social, emotional and cognitive processing in both individuals with PTSD~     and group-matched trauma controls (TC) and healthy controls (HC). Once the machine is~     validated, we will then use a more specific biomarker to better understand the neurochemical~     factors that contribute to individual differences in PTSD. Thus, the data obtained from this~     pilot study will guide our future molecular imaging studies. The link between general brain~     function, specific molecular target and the intrinsic functional connectivity of brain~     circuits that are responsible for social, emotional and cognitive processing in PTSD, TC and~     HC will be explored.~   "
115663|NCT02053519|"~     Evidence suggests that vitamin D may be directly or indirectly a co-factor for the efficacy~     of Hepatitis C virus, (HCV), antiviral therapies. The level of vitamin D necessary for~     optimum immune function is ill defined and many of those with HCV infection in Scotland are~     below these levels. Vitamin D is a cheap and safe medication, so its addition to anti-viral~     therapy should be highly cost-effective even if only a modest increase in SVR was achieved.~     Given the Scottish HCV epidemic, the world leading government response to it and the~     nationally low vitamin D levels, Scotland is perfectly placed to answer this question.~     Therefore the investigators hypothesize that vitamin D supplementation will improve SVR and~     propose a randomised controlled trial to test this hypothesis. The anticipated end of study~     date for this study is April 2015~   "
115664|NCT02053506|"~     Physical and psychological stress on military personnel during training and operational~     missions can suppress immune function. Creating superficial skin wounds via suction blisters~     can be used to detect changes in immune function. The goals of this research are to: 1)~     identify changes in immune function (blood measures and healing time of skin wounds) in~     response to sleep restriction; and, 2) test the influence of a multi-nutrient beverage and~     healthy bacteria (i.e., probiotics) on immune function (blood measures and healing time of~     skin wounds) in response to sleep restriction.~   "
115665|NCT02053493|"~     A randomized, double-blinded, placebo-controlled crossover study to assess effect of~     isosorbide mononitrate with dose up-titration on activity tolerance as assessed by (hip-worn,~     tri-axial) accelerometry.~   "
115666|NCT02053480|"~     The purpose of this study is to describe the range and incidence of symptoms, treatments, and~     complications related to pyruvate kinase deficiency (PKD). Eligible patients are those of all~     ages with known PKD or with a hemolytic anemia and a family member with PKD. The study will~     collect retrospective medical history, routine clinical care data, and quality of life~     measures at baseline and annually for patients with PKD.~   "
115708|NCT02052934|"~     A Phase 1 dose escalating study of ETEC candidate vaccine to determine safety and~     immunogenicity of a multi-dose regimen in healthy adult volunteers. The study will be~     conducted at Cincinnati Children's Hospital Medical Center (CCHMC). The primary objectives~     assess the safety and tolerability of dmLT vaccine when administered in three doses~     sublingually over a range of dosages in healthy adult subjects. The secondary objectives~     assess long-term safety follow-up from immunization through Month 7 post vaccination,~     following three SL doses of dmLT vaccine over a range of dosages and comparing with three~     doses of a comparable dosage of oral vaccine. The study subject population is 52 healthy~     adult male and female subjects, ages 18 to 45. Subject participation duration is~     approximately 8 months with study duration of approximately 1.5-2 years, including 6-7 months~     of follow-up.~   "
115667|NCT02053467|"~     The consultation-referral process is complex, involving several steps including 1) the PCP~     recognizing the need for specialist advice/intervention, 2) patient agreement on seeing the~     specialist, 3) referral letter and information sent to specialist, 4) appointment booked and~     communicated, 5) patient visit(s) with the specialist and 6) communication back to the PCP.~      There are many factors during this process which limit the effectiveness and efficiency of~     patient care. These include inequitable access for patients and providers, long wait times~     before specialist advice received/implemented, delayed communication and mismatched consult~     expectations. These gaps result in significant breakdowns in transitions of care,~     inappropriate treatment, patient dissatisfaction and potential harm. Moreover, not all~     individuals are willing or able to travel to see specialists in a large academic medical~     centre even when recommended by the PCP.~      eConsultation has the potential for improving transitions in care through improved~     communication ensuring that patients are seen by the right specialist, when necessary, with~     the right information and in a timely manner. The goal of this project is to evaluate the~     impact of eConsultation on specialist referral rates.~   "
115668|NCT02053454|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK)~     of patisiran (ALN-TTR02) in Japanese subjects~   "
115669|NCT02053441|"~     In this study will measure differences in how muscle responds to both exercise and protein~     supplements in healthy women aged 60-69. We are studying two different protein supplements- a~     standard Whey Protein and a Leucine enriched supplement. Each patient would receive either~     one of these.~   "
115670|NCT02053428|"~     Percutaneous image-guided gastrostomy (PIG) is an increasingly popular technique of creating~     gastroenteric access through the anterior abdominal wall for nutrition and/ or compression.~     Large-bore mushroom-retained catheters via the pull technique and small-bore cope loop~     catheters via the push technique are both used at Interventional Radiology for PIG at our~     institution. To date, there is no guideline for PIG and no direct comparison of two PIG~     techniques. The proposed pilot study is to compare the two different types of PIG techniques~     in head and neck cancer patients who require prophylactic enteral feeding by PIG. The purpose~     of the study is to assess the feasibility of a large randomized clinical trial to compare~     these two PIG techniques.~   "
115671|NCT02053415|"~     The purpose of this study is to examine whether 4 weeks daily intake of krill oil can change~     the omega-3 index (content of the long chained fatty acids EPA and DHA in relation to the~     total fatty acids) in the membrane in red blood cells. We investigate this at two different~     doses. Furthermore, the purpose of the study is also to examine the effect of the krill oil~     intake on plasma lipids (triacylglycerol, phospholipids and cholesterol), plasma fatty acid~     composition, as well as product tolerance in healthy, young individuals.~   "
115672|NCT02053402|"~     The aim of this randomized double-blind placebo controlled study is to assess whether vitamin~     D supplementation will improve control in South African children with persistent asthma at an~     academic hospital.~      The following hypotheses will be tested: Vitamin D significantly and directly correlates with~     poor control of persistent asthma; Daily vitamin D supplementation for six months will result~     in improved control of persistent asthma compared to a placebo.~      It is intended to enroll 100 children between the ages of 6 to 12 years with persistent~     asthma on inhaled therapy. The sample size calculations are based on the hypothesis that~     vitamin D supplementation will result in a 25% improvement in asthma symptoms as measured by~     the Asthma Treatment Assessment Questionnaire (ATAQ) and peak flow readings. The children~     will be randomized into one of two groups; one group will be given 1200 IU of vitamin and the~     other a placebo. The vitamin D or placebo will be given in the morning daily to each child~     for six months. The children will be assessed monthly by the study physician, to evaluate for~     signs of poor asthma control e.g. persistent cough and recurrent wheezing. The heights and~     weights and peak expiratory flow meter readings will also be obtained monthly for six months.~     Blood samples will be taken for Vitamin D levels, calcium, phosphorus levels at baseline,~     third month and at the end of the study. All enrolled children will be required to produce~     their tablet containers for pill counting on a monthly basis to ensure adherence.~   "
115673|NCT02053389|"~     This is an educational intervention study testing the effects of decision aids in promoting~     patient participation in early stage prostate cancer treatment decision making. The purpose~     of this study is to compare patient-physician communication between patients who receive a~     DVD that models patient communication strategies vs. those who do not receive a DVD. All~     patients will also receive a written decision aid that describes treatment options for early~     stage prostate cancer. The Investigators hypothesize that the DVD will:~        -  increase patients' perceptions of the importance of their preferences to their decision~          making~        -  increase patients' perceptions of their intention to discuss their values and~          preferences with their urologists and radiation oncologists~        -  increase patients' actual engagement with their physician during the clinical encounter~        -  increase the concordance between patient decision making preferences and actual decision~          making outcomes~        -  increase long term satisfaction with decision on type of treatment selected~        -  increase patient satisfaction with their decision and the decision making process~        -  influence patient perception of his physician (e.g., trust) and of the diagnosis visit~   "
115709|NCT02052921|"~     With the possibility of pathological complete response in surgical specimens, some authors~     have proposed non-operative management of the patient group, when re-staged after neoadjuvant~     treatment, have complete clinical response. So far, this approach remains discussed in the~     literature, and there are still many uncertainties that patients with clinical complete~     response after chemoradiotherapy in fact no detectable viable tumor and may be omitted of~     radical surgical treatment. It is a still investigational approach and actually gained space~     even for patients with very high or who refuse surgery after all clarifications surgical~     risk.~      Hypothesis: The preservation of the rectum in patients with adenocarcinoma of the middle and~     distal rectum (up to 10 cm) reaching clinical complete response after neoadjuvant~     chemoradiotherapy have similar rate of the rectal cancer recurrence than patients who~     underwent surgical rectal resection.~      This will be a prospective, randomized, open label phase II of surgical resection versus~     conservative treatment (observation) in patients with mid and distal rectal cancer who~     achieved complete after neoadjuvant chemoradiotherapy combined with clinical response.~      The main objective of this study is to assess whether conservative approach is similar to~     rectosigmoidectomy with complete mesorectal excision or amputation abdminoperineal the rectum~     in patients with complete clinical response after neoadjuvant therapy combined~     chemoradiotherapy.~      Patient Selection: To be eligible patients who have neoadjuvant prior histologic diagnosis of~     rectal adenocarcinoma, tumors located within 10 cm from the anal verge, a complete clinical~     response after treatment with chemoradiotherapy for rectal tumors staged clinical and~     radiological T3-4 N0 M0 or T (any) N + M0, absence of colorectal synchronous tumors.~      Treatment: Eligible patients will be randomized 1:1 to resection of the rectum or notice. The~     period for randomization of patients will be 12 weeks after the last dose of radiotherapy /~     chemotherapy, so that we can properly assess the antitumor response as described above. After~     randomization, patients in the surgical group will undergo resection of the rectum with~     complete excision of mesorectal within 2 weeks after randomization.~   "
115674|NCT02053376|"~     As noted, multiple pathways, including epidermal growth factor receptor (EGFR), Ras, Raf,~     Vascular Endothelial Growth Factor Receptors (VEGFR), and platelet-derived growth factor~     (PDGFR) appear to be involved in cholangiocarcinoma tumor genesis. Overexpression of these~     proteins has been shown to be associated with tumor stage, prognosis, and response to~     therapy. However, therapies targeting a single pathway have shown no clear benefit. A number~     of Phase 2 trials have been completed, or are underway, studying agents targeted to EGFR or~     VEGF - both as monotherapy and in combination with chemotherapy. These have shown varying~     increases in response rate, but have not found marked increases in progression-free or~     overall survival. This suggests that inhibition of multiple pathways simultaneously may be~     needed. Regorafenib, is an oral multikinase inhibitor targeting multiple tumor pathways,~     which has showed effectiveness as a single agent in multiple solid tumors.~      The primary objective of this clinical trial is to evaluate the progression-free survival~     (PFS) of patients receiving regorafenib after failing first-line chemotherapy. Patients with~     advanced and metastatic biliary tract adenocarcinoma (cholangiocarcinoma) who had been~     treated with and failed first-line chemotherapy will be treated with regorafenib (160 mg)~     orally once daily 21 days (3 weeks) on and 7 days (1 week) off in the 28-day (4-week) cycle.~   "
115675|NCT02053363|"~     The purpose of this study is to evaluate two dosing protocols for tranexamic acid (TXA), an~     anti-fibrinolytic used to decrease blood loss in adult patients undergoing complex,~     reconstructive spinal fusion surgeries.~   "
115676|NCT02053350|"~     The aim of this study is to test the efficacy of alanyl-glutamine supplementation in the~     treatment of C. difficile infection. We hypothesize that alanyl-glutamine when given with~     standard antibiotic treatment for C. difficile infection will decrease diarrhea, mortality~     and recurrent disease.~   "
115677|NCT02053337|"~     ALLEVYN◊ Life and Mepilex™ Border are both layered foam dressings with a silicone adhesive~     wound contact layer. Both are indicated for the same uses; however ALLEVYN◊ Life has a number~     of attributes designed to meet a range of characteristics associated with principles of~     wellbeing.~      The aim for this evaluation is to assess, in a clinical setting and against a number of~     identified criteria, the performance of the ALLEVYN◊ Life dressing compared to Mepilex™~     Border in terms of characteristics of the attributes of wellbeing.~      ◊ Trademark of Smith & Nephew~      ™ All trademarks acknowledged~   "
115678|NCT02053324|"~     The purpose of the study is to assess a new treatment for patients with liver tumor~     metastases from colorectal cancer. The treatment has never been used in humans before. The~     treatment foresees the use of two compounds: AvdinOX and [177Lu]DOTA-biotin.~      AvidinOX is a new compound, essentially a natural protein obtained from hen eggs, while~     [177Lu]DOTA-biotin is a new chemical compound resulting from the combination of the~     DOTA-biotin (also deriving from a natural vitamin which is biotin) with the 177Lutetium, an~     atom which emits radiation.~      AvidinOX will be injected directly into the metastases in the liver and [177Lu]DOTA-biotin~     will be injected into the arm vein.~      One specific property of AvidinOX is that it chemically links to the tumor tissues when it is~     injected while maintaining the capacity to take up [177Lu]DOTA-biotin. Once locally bound in~     tumor tissue, AvidinOX becomes an artificial receptor for intravenously injected~     [177Lu]DOTA-biotin, which allows an internal radiation therapy of the tumor tissue.~      The treatment of liver metastases with local injection of AvidinOX and the following~     intra-venous injection of [177Lu]DOTA-biotin could be simpler and more tolerable than the~     current available treatments.~   "
115679|NCT02053311|"~     The main object of this multicenter, randomized, double-blind, placebo-controlled phase III~     trial is to assess impact of maintenance of orteronel on disease progression and hence on~     quality of life of patients with metastatic castration resistant prostate cancer pretreated~     with novel hormonal agents who have non-progressive disease after chemotherapy with a taxane.~   "
115680|NCT02053298|"~     Glaucoma is an optic neuropathy in which the main risk factor is intraocular pressure (IOP).~     The search for other variables involved in glaucoma pathogenesis and progression has~     identified both systemic and ocular signs of vascular dysfunction in glaucoma patients, such~     as migraine, peripheral vasospasm, systemic hypotension and cerebral microvascular ischemia.~     Ocular blood flow studies using Color Doppler Imaging (CDI) technology has demonstrated blood~     velocities and increased vascular resistance (RI) to exist in such patients when compared to~     healthy controls. However, a CDI examination provides far more additional information, such~     as arterial pulsatility (PI) and mean blood velocities (MFV). While these have been used for~     decades now to study cerebral arteries vasoreactivity, little is known about how these~     variables are changed in glaucoma patients. We have recently demonstrated that these~     variables can be used to identify a change in the normal vascular activity when there is~     increased resistance. In glaucoma patients, a cutpoint in RI of the retrobulbar arteries~     could be determined beyond which PI increased significantly. This sharp increase in the PI~     has been used as an indirect signal that the vessel's ability to buffer a decreased perfusion~     pressure has been surpassed. The normal response to a decreased perfusion in a vascular~     territory with autoregulation is an increase in dilation in the downstream microcirculation,~     increasing cross section area in an attempt to keep a steady MFV. As PI is calculated using~     the vessel's MFV [PI = (PSV-EDV)/MFV], it is highly sensitive to changes in this variable. As~     such, the cutpoints we have identified in glaucoma patients are therefore an indirect~     assessment of the vessel's autoregulation limit.~      While our data could provide the rational as to why these RI values are associated with~     progression, the clinical question arises as to whether these cutpoints can be modulated by~     topical glaucoma therapy. As some medications such as carbonic anhydrase inhibitors have been~     found to have a positive effect in disease progression in what appears to be a non-IOP~     related effect, we considered the hypothesis that these drugs could have a positive impact on~     the ocular's microcirculation vasoactive response, potentially enabling to keep a steady MFV~     into higher values of vascular resistance.~   "
115681|NCT02053285|"~     Dual-energy CT (DECT) provides information on the blood volume in tumors and lymph nodes. As~     tumors respond to treatment, preliminary data suggests that the blood volumes changes as~     well. Investigators are therefore using DECT to test whether it can be used on radiation~     treatment to rapidly assess response to treatment.~   "
115682|NCT02053272|"~     A study to compare the change in glycaemic control in participants with Type 2 diabetes when~     treated with GWP42004 or placebo as add-on therapy to metformin over a period of 12 weeks.~     The safety and tolerability of GWP42004 compared with placebo will also be assessed.~   "
115710|NCT02052908|"~     This randomized phase Ib trial studies the side effects and best dose of naproxen in~     preventing deoxyribonucleic acid (DNA) mismatch repair deficient colorectal cancer in~     patients with Lynch syndrome. Chemoprevention is the use of certain drugs to keep cancer from~     forming. The use of naproxen may keep cancer from forming in patients with Lynch syndrome.~   "
115711|NCT02052895|"~     This is an observational study to evaluate the diagnostic accuracy of presepsin levels to~     discriminate between sepsis and SIRS upon presentation with critical illness compatible with~     either sepsis or systemic inflammatory response syndrome (SIRS).~   "
115683|NCT02053259|"~     The purpose of this study is to develop and evaluate adaptive goal setting and feedback~     interventions (Adaptive Interventions) to promote physical activity behaviors and compare it~     to static physical activity interventions (Static Interventions) using two levels of goal~     setting (Adaptive Goals vs. Static Goals) and two levels of reinforcement procedures~     (Praise/Rewards and No Praise/Rewards) in a 2 x 2 factorial randomized controlled trial. All~     four groups will receive the intervention via a semi-automated text message system developed~     by the investigators study team.~      The primary aim of this study will be to:~        1. Evaluate whether the adaptive interventions result in greater change in physical~          activity (pedometer-measured steps/day) compared to the static Intervention groups.~          HYPOTHESES: Participants in the adaptive interventions will increase their steps/day~          more than participants in the Static Intervention groups. The Adaptive Goals and~          Reinforcement Group will outperform the other 3 groups.~           The secondary aims of this study will be to:~        2. Evaluate the effectiveness of the adaptive and static goal interventions in improving~          anthropometric, cardiovascular fitness, and cardiometabolic risk factors. HYPOTHESES:~          Participants in the adaptive interventions will show greater improvements in fitness,~          lean and fat body mass, and serum biomarkers than participants in the Static~          Intervention groups. The Adaptive Goals and Reinforcement Group will outperform the~          other 3 groups.~        3. to assess participants' satisfaction with the overall program.~   "
115684|NCT02053246|"~     Heart failure with preserved ejection fraction (HFpEF), is one of the leading causes of~     pulmonary hypertension (PH). Despite the severity of this disease, no established treatments~     exist for this class of PH. Nebivolol is a drug used in high blood pressure and heart~     failure, but not used in patients with PH. Due to some additional properties it possesses,~     the investigators believe nebivolol will improve disease severity in patients with PH~     associated with HFpEF. The hypothesis of this research study is that nebivolol improves PH~     severity in patients with HFpEF, as measured by hemodynamic and clinical parameters.~   "
115685|NCT02053233|"~     The robot assisted therapy is one of the new developed technologies for recovery after~     stroke. This study aimed to evaluating the effect of robotic gait therapy for motor recovery~     after stroke.~   "
115686|NCT02053220|"~     To assess the pattern of ColoAd1 viral delivery and viral expression within colon tumour~     tissue when administered by intra-tumoural injection or within colon, non-small cell lung,~     bladder and renal cell tumour tissues following ColoAd1 administration by intravenous~     infusion.~   "
115687|NCT02053207|"~     The purpose of this study is to evaluate the feasibility of administering a 20-day~     preoperative cognitive training intervention (Cog-Train) to a widely inclusive sample of~     cardiac surgical patients.~   "
115688|NCT02053194|"~     The objective of this trial is to test the beneficial effect of a pharmacist-initiated~     knowledge transfer intervention to both patients and prescribers on the discontinuation of~     inappropriate prescriptions, compared to usual care. The investigators hypothesize that the~     pharmacist-led intervention will reduce inappropriate prescriptions by at least 20% over~     6-months compared to usual care. The intervention consists of simultaneously educating~     consumers and providing physicians with an evidence-based pharmaceutical opinion on~     inappropriate prescriptions.~   "
115689|NCT02053181|"~     The study investigated the pharmacokinetics, safety, and tolerability of cadazolid in~     subjects with severe Clostridium difficile diarrhea (CDAD) and whether this influenced the~     quantity of cadazolid absorbed into the systemic circulation.~   "
115690|NCT02053168|"~     Collect data on safety, performance, and effectiveness of Phasix Mesh in subject requiring~     primary ventral and incisional hernias.~   "
115691|NCT02053155|"~     Implementation of a perioperative smoking cessation program with computer based patient~     education increases the rate of short term (1 month) and long term (6 month) reduces the~     incidence of perioperative complications in elective surgical patients.~   "
115692|NCT02053142|"~     This is a prospective study to evaluate the pharmacokinetics, clinical and virologic response~     to acyclovir episodic therapy for genital herpes ulcers in HIV negative African women.~   "
115693|NCT02053129|"~     This is a pilot pulmonary TB screening program done in three antenatal care clinics in~     Lusaka, Zambia to determine the prevalence of culture-confirmed pulmonary tuberculosis and to~     determine the sensitivity and specificity of symptom-based TB screening.~   "
115694|NCT02053116|"~     A Phase 2a study to evaluate the effects of an investigational compound administered at 200~     mg, twice daily (BID), for 6 weeks, with canagliflozin, in adult subjects with Type 2~     Diabetes Mellitus (T2DM).~   "
115695|NCT02053103|"~     A Phase 2a study to evaluate the effects of an investigational compound administered at 200~     mg, twice daily (BID), for 6 weeks in adult subjects with Type 2 Diabetes Mellitus (T2DM) on~     metformin background therapy.~   "
115696|NCT02053090|"~     This study is an acceptability and feasibility study of two adjunctive interventions: group~     education with stretching; and group acupuncture. The study population will be women with~     primary fibromyalgia who have not previously used acupuncture in the last 3 months. Both~     interventions will be 10 weeks in length and will be conducted at the Oregon Health & Science~     University. The primary hypothesis is that both arms will be acceptable and feasible in the~     study population.~   "
115697|NCT02053077|"~     Identification of risks of the GlucoTab system in routine use.~   "
115698|NCT02053064|"~     P2-SAF-301 is an open-label interventional study without administration of investigational~     product, evaluating the long-term safety and tolerability of intracerebral SAF-301 previously~     administered to 4 patients with Sanfilippo type A syndrome.~      The primary objective is to collect additional safety and tolerability data on intracerebral~     SAF-301 previously administered to 4 patients with Sanfilippo type A syndrome.~      The secondary objective is to further collect data to assess the effects of SAF-301 on~     neurological and psychological status, and potential biological markers.~   "
115712|NCT02052882|"~     This study is to determine if using weekly romiplostim injections will improve the patient's~     platelet count more effectively than simply waiting for the platelets to improve on its own,~     and if romiplostim will also allow the patient to receive at least 2 further cycles of~     chemotherapy without thrombocytopenia.~   "
124413|NCT01939028|"~     This clinical trial studies lymph node mapping in patients with newly diagnosed endometrial~     cancer undergoing surgery. Lymph node mapping may help in planning surgery to remove~     endometrial cancer and affected lymph nodes.~   "
115699|NCT02053051|"~     This study aims to assess the safety and efficacy of a novel advanced bolus calculator in~     subjects with Type 1 diabetes. Insulin bolus calculators have been developed to aid insulin~     dose adjustment and existing standard insulin bolus calculator consist of a simple algorithm~     that requires five subject-specific parameters as input to generate a recommended bolus~     insulin dose:~        -  current blood glucose (mmol/L)~        -  target blood glucose (mmol/L)~        -  insulin-to-carbohydrate ratio (grams of carbohydrate per 1 unit of insulin)~        -  total grams of carbohydrate in meals~        -  insulin sensitivity factor (reduction in glucose per 1 unit of insulin)~      The Diabetes Technology team at Imperial College have developed a novel advanced bolus~     calculator. The complete integrated system consists of a commercially available smartphone~     that holds the novel advanced algorithm. The system requires regular updates of cases derived~     from retrospective blinded continuous glucose monitoring data and for this a commercially~     available glucose sensor will be used. Each new case includes information about the problem~     (e.g. capillary blood glucose, meal information and physical exercise), solution (recommended~     insulin dose) and outcome (blood glucose following a meal). The novel decision support~     algorithm is based on case-based reasoning (CBR). CBR is an artificial intelligence technique~     that tries to solve newly encountered problems by applying the solutions learned from solved~     problems encountered in the past.~      The end-product is therefore a subject specific insulin bolus calculator that continues to~     improve with time. The project utilises commercially available glucose sensors and~     smartphones (iPhone), integrated with a novel algorithm for insulin bolus calculation. The~     aim of the ABC4D is to minimise high and low glucose excursions which are associated with the~     complications of diabetes including blindness, kidney failure, nerve damage and~     cardiovascular disease.~      The clinical study has been designed to incrementally assess the device's ability to manage~     meal time insulin requirements at breakfast and lunch in a controlled supervised clinical~     environment over 8 hours (phase 1), followed by its use in the home environment over a 6 week~     period (phase 2) and finally over a 6 month period (phase 3).~   "
115700|NCT02053038|"~     Narrowing of coronary arteries interferes with blood flow and can cause chest pain. But~     patients may have more than one narrowing and studies have shown that not all narrowings need~     to be treated. To identify the narrowings that need treating cardiologists sometimes quantify~     the extent of the narrowing by measuring fractional flow reserve (FFR, the ratio of the~     pressure in the aorta to the pressure downstream of the narrowing).This technique requires~     the administration of drugs that add cost and time to the procedure and in some countries are~     simply unavailable. As a result despite the clear health and healthcare costs benefits of FFR~     its use is limited to less than 5% of procedure. We have developed a new technique called the~     instantaneous wave-free ratio (iFR) that does not require the administration of drugs for its~     accurate assessment. It has been approved for use in this indication. This study aims to~     compare clinical outcomes of patients whose treatment has been guided by iFR to those whose~     treatment has been guided by FFR. If iFR is found to provide the same clinical outcomes as~     FFR its adoption will permit the clear benefits of this approach of identifying the coronary~     narrowings that really need treatment to be applicable to a much larger patient population~     and further improve healthcare costs.~   "
115701|NCT02053025|"~     The purpose of this study is to investigate the effect of eating various levels of~     mycoprotein (Quorn) on feelings of appetite, energy intake and levels of gut hormones in~     overweight volunteers.~   "
115702|NCT02053012|"~     The investigators feel that children who have OSA or sleep-disordered breathing may have a~     different reaction time than normal variants. Children who have OSA are known to have~     behavioral and sleep patterns that are different. It makes sense their reaction time may be~     different than normal as well. We plan to measure reaction times via a 10 minute psychomotor~     vigilance test device in children who snore who are coming in for a sleep study or for~     adenotonsillectomy.~   "
115703|NCT02052999|"~     The objective of this study is to determine the efficacy and safety of PAC-14028 1% cream of~     Amorepacific Corporation in patients with erythema-telangiectatic or papulopustular rosacea~   "
115704|NCT02052986|"~     The investigators aim to test the hypothesis that dietary supplementation with VASCAZEN will~     correct omega-3 deficiency in cardiac rehab patients and improve biochemical risk factors.~   "
115705|NCT02052973|"~     This study aims to evaluate the effectiveness of a varnish containing 15% of green propolis~     on Streptococcus mutans in saliva and biofilm. Will be invited to join the study: children~     8-10 years old, free of caries, without orthodontic appliances and without having undergone~     antibiotic therapy until three weeks before the start of the study. Saliva will be collected~     before, immediately after, 24 hours and 30 days after application of the varnish. The~     collection of biofilm will be performed before, after, 24 hours and 30 days after application~     of the varnish. Data will be collected and compared between periods.~   "
115706|NCT02052960|"~     The aim of the study is to evaluate the efficacy of CetuGEX™ for the treatment of patients~     with stage III/IV recurrent and/or metastatic SCCHN as compared to cetuximab (both in~     combination with platinum-based chemotherapy) in terms of progression-free survival (PFS).~   "
115707|NCT02052947|"~     One of the crucial challenges for the future of Alzheimer's disease (AD) therapeutic~     approaches in elderly is to target the main pathological process responsible for disability~     and dependency. However, a progressive cognitive impairment occurring after the age of 70 is~     often related to mixed lesions of neurodegenerative and vascular origins. Whereas young~     patients are mostly affected by pure lesions, aging favors the occurrence of co-lesions of~     AD, vascular and Lewy body types. Pure DLB (Dementia with Lewy Body) and AD are distinct~     disorders but they often coexist in old age patients, the Abeta pathology of DLB/AD cases~     being different to that observed in patients with AD alone. Vascular dementia (VD) and AD~     with cerebrovascular disease (AD+CVD) are the leading causes of dementia next to AD alone.~     Lack of consensus persists about the diagnosis criteria for VD and AD+CVD, due in part to~     their clinical, pathological heterogeneity and the multiple pathological subtypes.~      We do not know the precise role and weight of each brain lesion type in the disability~     progression in elderly. To target the actual pathological process, we need to disclose the~     functional weight of AD, Lewy body and vascular lesion types in elderly. Most of the studies~     report on functional and clinical abnormalities in patients with pure pathologies. Thus,~     co-morbid processes involved in the transition from an independent functional status to~     disability in the elderly with co-lesions still remain to be elucidated. Neuropathological~     examination often performed at late stages cannot answer this question at mild or moderate~     stages.~      Brain MRI, Single Photon Emission Computed Tomography (SPECT) with DaTscan® and CSF~     biomarkers help routinely in performing the diagnosis of pure or mixed lesions responsible~     for dementia. The topography of the atrophy in MRI helps to provide information about the~     etiological diagnosis. Medial temporal lobe atrophy on MRI has good discriminatory power for~     AD compared to DLB and VD in pathologically confirmed cases. DaTscan® SPECT presents with~     good sensitivity and specificity at early stages of DLB. The good diagnosis value of CSF~     biological markers has led recently to their inclusion in the research diagnosis criteria of~     AD. Low Aβ1-42 and high levels of total tau and hyperphosphorylated tau isoforms appear to be~     the most sensitive and specific CSF biomarkers. Aβ1-42 is lowered in AD, as well as in other~     neurodegenerative diseases like DLB, VD. The combination of MRI, particularly medial temporal~     atrophy measures and vascular lesions on FLAIR MRI sequences, SPECT and CSF biomarkers seem~     to be of incremental value for the diagnosis AD, VD, DLB and mixed profiles.~      The aim of this study is to identify the biomarkers (MRI, SPECT-DaTscan® and CSF), and their~     combination, that are the most predictive of functional disability in elderly presenting with~     a progressive cognitive decline related to AD, DLB, VD and all mixed patterns.~   "
115750|NCT02052375|"~     The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of~     two dosing regimens of multiple, subcutaneous (sc) injections of ASP2408 in patients with~     Rheumatoid Arthritis (RA) on Methotrexate (MTX) and to evaluate the pharmacodynamics (PD) of~     ASP2408.~   "
115751|NCT02052362|"~     A study to investigate the fraction of ABT-267 and ABT-450 absorbed by the body when given in~     combination with each other and Ritonavir(r).~   "
115713|NCT02052869|"~     In endotracheal intubation, it is essential that the trachea is intubated and not the~     esophagus. In suboptimal situations (outside an operating theatre), malpositioning of the~     endotracheal tube occurs frequently and is often fatal. The diagnostic tools that are~     available in the operating theatre are not appropriate for out-of-hospital situations because~     of several reasons. Moreover, these methods mostly take some time to provide the desired~     information and don't have optimal specificity and sensitivity. In order to allow fast~     diagnosis of this potentially fatal complication, we have developed a fully-automatic~     detection device to diagnose endotracheal tube malpositioning within 2 seconds.~      A high sensitivity/specificity of the algorithm for waveform-analysis was demonstrated in~     healthy patients and patients with pulmonary diseases (decreased pulmonary compliance).~      A new stand-alone device with integrated sensors and microprocessor was developed that gives~     immediate diagnosis, and stores data for subsequent research purpose. This device will be~     evaluated in perioperative situations to demonstrate the high sensitivity and specificity in~     patients in a clinical setting.~   "
115714|NCT02052856|"~     The purpose of this study is to evaluate the incidence and degree of bone tunnel widening~     between two groups who have undergone anterior cruciate ligament reconstructive surgery. The~     two groups have undergone different graft fixation methods: an interference screw/suspensory~     button fixation hybrid technique, and an all-inside suspensory method fixation. Tunnels are~     created at the time of surgery for graft placement and fixation, but have been known to~     enlarge post-operatively. Little has been studied on the relatively new all-inside technique.~     X-rays of the operative knee will be used to assess tunnel width. Secondary outcomes will~     include clinical evaluation and outcome scoring questionnaires~   "
115715|NCT02052843|"~     The evaluation will examine whether the Steps to Success enhanced home visits are more~     effective at delaying repeat pregnancies than are traditional Healthy Families home visits.~   "
115716|NCT02052830|"~     The purpose of this study is to evaluate the impact of the Wise Guys program on the delaying~     sexual initiation on adolescent males in Eastern Iowa.~   "
115717|NCT02052817|"~     The TOAD Medical Corporation Brace is a novel device that completely off-loads the foot and~     has been shown to heal ulcers at a rapid rate in preliminary experience in patients with~     plantar ulcers. This trial will attempt to show the efficacy of the Toad Brace and is based~     on the hypothesis that the Toad brace completely offloads the foot and hastens healing rates~     of diabetic ulcers. The trial will randomize 74 patients with diabetic pedal ulcers to the~     Toad Brace or conventional therapy. . Quantitative assessment of ulcer rate healing rates~     will be determined clinically and by blinded, computer-assisted planimetry of digital images~     over a 12 week period. The pressure on the plantar surface will be measured via a pressure~     sensor in a subset of patients. The trials will attempt to show markedly reduced pressure on~     the plantar surface and significantly higher ulcer healing rates with using the Toad Brace.~   "
115718|NCT02052804|"~     The objectives of this study are: 1) to design new diagnostic criteria used to accurately~     define heart failure with preserved ejection fraction (HFpEF); 2) to better define the risk~     factors associated with HFpEF; 3) to elucidate the clinical, cellular and molecular~     mechanisms involved with the development and progression of HFpEF; 4) to design and test new~     therapeutic strategies for patients with HFpEF.~   "
115719|NCT02052791|"~     The primary objective of this study is to examine the safety and tolerability of nusinersen~     (ISIS 396443) administered intrathecally to participants with Spinal Muscular Atrophy (SMA)~     who previously participated in ISIS 396443-CS2 (NCT01703988) or ISIS 396443-CS10~     (NCT01780246). The secondary objective is to examine the plasma and cerebrospinal fluid (CSF)~     pharmacokinetic(s) (PK) of nusinersen administered intrathecally to participants with SMA who~     previously participated in ISIS 396443-CS2 or ISIS 396443-CS10.~   "
115720|NCT02052778|"~     This is an open-label, nonrandomized, Phase 1 dose-escalation, dose-expansion, and Phase 2~     study targeting tumors with FGF/FGFR aberrations. The purpose of the study is to evaluate the~     safety, tolerability, PK, pharmacodynamic, and anti-tumor activity of TAS-120 in patients~     with advanced solid tumors with and without FGF/FGFR-related abnormalities.~      The study will be conducted in 3 parts, (1) Dose escalation to determine the MTD and/ or RP2D~     of TAS-120 in which this part of the study has been completed; (2) Phase 1 expansion to~     further evaluate the safety and efficacy of RP2D of TAS-120 in patients with tumors harboring~     specific FGFR aberrations, specifically in patients with cholangiocarcinoma, gliomas ,~     urothelial carcinomas and any other tumors with FGFR fusion or activating mutation or~     amplification. Up to approximately 185 patients will be enrolled in the phase 1 expansion;~     and (3) Phase 2 study to confirm ORR of TAS-120 in intra-hepatic CCA patients with tumors~     harboring FGFR2 gene fusions. Approx. 100 patients will be enrolled in phase 2.~   "
115721|NCT02052765|"~     Brugada syndrome is characterized by a ST shift on the surface ECG, and a specific morphology~     of the Twave. This ECG abnormality is called a type 1-ECG, and is variable in time. Patients~     presenting a Brugada syndrome are exposed to sudden cardiac death, although it's difficult to~     predict patients at high risk. It is suspected that the type 1-ECG burden might be correlated~     to the ventricular fibrillation risk of these patients, but there is no mean to record the~     ECG over a long period of time.~      The objective of the study is to evaluate the correlation between ST elevation on the~     electrocardiogram (ECG) and ST shift on the intracardiac electrograms (EGM) recorded with the~     AnalyST ICD, to assess the ability of the device to detect the type 1-ECG. Patients enrolled~     in the study are patients already implanted with a defibrillator for their Brugada syndrome.~     During an Ajmalin test, which unmasks the type 1-ECG, both intracardiac EGM and surface ECG~     will be compared to assess the detection of the typical ST-shift by the ICD.~   "
115722|NCT02052752|"~     5 Day study to assess how quickly a topical acne product begins to work.~   "
115723|NCT02052739|"~     The purpose of this study is to evaluate the safety and tolerability of SAGE-547 in subjects~     in super-refractory status epilepticus (SRSE).~   "
115724|NCT02052726|"~     This study will investigate a clostridium difficile vaccine in healthy adults aged 50 to 85~     years, who will each receive 3 doses of vaccine. Subjects will receive their vaccine doses at~     either months 0, 1, and 3 or days 1, 8, and 30. Subjects will be divided into 2 age groups~     (50-64 and 65-85 years of age). The study will assess how safe and tolerable the vaccine is,~     and also look at subjects' immune response to the vaccine.~   "
115725|NCT02052713|"~     The purpose of this study is to assess the bioequivalence of the second generation~     dutasteride and tamsulosin hydrochloride (HCL) combination capsule versus currently available~     commercial combination of dutasteride 0.5 milligram (mg) and tamsulosin HCL 0.4 mg capsule in~     healthy adult male subjects. Subjects in this study will receive either a single oral dose of~     the second generation dutasteride 0.5 mg and tamsulosin 0.4 mg combination capsule or a~     single dose of commercially available combination of dutasteride 0.5 mg and tamsulosin HCL~     0.4 mg followed by a 28-day washout period both in fasted state. The study will enroll~     approximately 92 healthy adult male subjects in order to complete approximately 76 evaluable~     subjects. The total duration of a subject's involvement in this study is anticipated to be~     approximately 12 weeks.~   "
115726|NCT02052687|"~     The purpose of this first-in human study is to demonstrate systemic and local tolerability~     and investigate pharmacokinetics of LFX453 after multiple topical applications in healthy~     subjects.~      The current study has been designed with three distinct parts. Part 1 focuses on safety and~     tolerability of once daily application on the back, prior to moving forward and assessing the~     safety and tolerability in more sensitive treatment areas in Part 2 or twice daily~     application in Part 3.~   "
115727|NCT02052674|"~     The purpose of this study is to see if there are differences in urine drainage between two~     types of indwelling bladder catheter systems (Foley catheter) in hospitalized patients. The~     difference between the two catheters is that one catheter is vented (the study catheter) and~     the other is a standard non-vented catheter. The vented catheter may drain urine better than~     a standard non-vented catheter.~      If a vented catheter drains the bladder better than a non-vented catheter it may lower the~     risk of retained urine in the bladder which could help prevent urinary tract infections.~   "
115728|NCT02052661|"~     The purpose of this study is to assess the long-term persistence of immunity to hepatitis B~     in adolescents aged 12-13 years who were vaccinated with four doses of Infanrix™-Hexa in~     infancy and to assess the anamnestic response, immunogenicity, safety and reactogenicity of a~     single challenge dose of the hepatitis B vaccine Engerix™-B Kinder.~   "
115729|NCT02052648|"~     In this study, investigators will conduct a phase I/II trial in recurrent (temozolomide~     resistant) glioma patients. The overall goal of this study is to provide a foundation for~     future studies with indoximod tested in newly diagnosed glioblastoma patients with radiation~     and temozolomide, or in combination with vaccine therapies.~   "
115730|NCT02052635|"~     The purpose of this study is to determine if ticagrelor is as effective as clopidogrel in~     rate of onset and degree of platelet inhibition for patients with non-ST elevation of acute~     coronary syndrome (NSTE-ACS) undergoing ad hoc percutaneous coronary intervention (PCI) with~     bivalirudin.~   "
115731|NCT02052622|"~     To investigate the long-term safety and maintenance of efficacy of ATX-101 in reduction of~     submental fat~   "
115732|NCT02052609|"~     This study is designed to evaluate the safety and efficacy of long-term exposure to KHK4827~     in subjects with plaque psoriasis (psoriasis vulgaris, psoriatic erythroderma) who have~     completed Study 4827-003 (Study 003)and in subjects with pustular psoriasis (generalized) or~     psoriatic erythroderma who have completed the Study 4827-004 (Study 004).~   "
115733|NCT02052596|"~     The purpose of this study is to assess immunogenicity, reactogenicity and safety of GSK~     Biologicals' HZ/su vaccine when its first dose is co-administered with the Boostrix® vaccine~     in adults aged 50 years or older compared to administration of vaccines separately.~   "
115734|NCT02052583|"~     Cardiac arrest is a major public health problem, with 700 000 cases per year , and a survival~     ranging from 4 to 33%. The post- anoxic encephalopathy remains the most serious complication~     with only a third of survivors . It is due to a series of phenomena involving~     microcirculation disorders . Cerebral oximetry is a new technique to evaluate the~     microcirculatory status . To this day it is used in cardiovascular surgery at risk of~     cerebral hypoperfusion where desaturation of cerebral oximetry is synonymous with ischemia~     and microcirculatory disorders. Therapeutic hypothermia is the only treatment improves the~     outcome of patients after extra- hospital cardiac arrest resuscitation . Its mechanisms of~     action seem to change all the phenomena responsible for microcirculatory reperfusion~     disorders . Currently it is recommended to practice hypothermia between 32 and 34 ° C.~     However, a recent study suggests a superiority of hypothermia at 32 ° C rather than 34 ° C.~      The hypothesis of this study is that cerebral oximetry value will be different in patients~     subjected to two different levels of therapeutic hypothermia in the aftermath of an extra-~     hospital cardiac arrest. These data allow a better understanding of the mechanisms underlying~     the benefit of this technique.~   "
115735|NCT02052570|"~     This is a qualitative study that will explore the experiences of school reentry following~     Hematopoietic Stem Cell Transplant (HSCT) in children ages 10-16 years of age, their parents,~     teachers and primary PBMT(Pediatric Bone Marrow Transplant) providers. This study will~     involve four focus groups: children post -transplant, parents, teachers and PBMT providers in~     an effort to understand the successes and challenges of returning to school following HSCT.~   "
115736|NCT02052557|"~     The purpose of the study is to evaluate the effect of Exparel on pain control and patient~     outcome after colon resection. The investigators will evaluate the clinical course of the~     patients who receive exparel as compared to the patients who do not receive exparel. Exparel~     is a 72 hour bupivacaine which is slowly released from lysosomes over the course of three~     days. A long acting local anesthetic should provide better pain control than conventional~     bupivacaine which has a 3.5 hour half-life.~   "
115737|NCT02052544|"~     To demonstrate the substantial equivalence (SE) of Pefakit® PiCT® UC (test device, T) to~     aPTT-SP (Hemosil) (predicate device, P) in determining heparin levels in subjects undergoing~     heparin therapy in support of a United States Food and Drug Administration (FDA) 510(k)~     submission.~   "
115738|NCT02052531|"~     The objective of this study was to find a clinically appropriate dose of PAC-14028 cream by~     comparatively evaluating the efficacy and safety of PAC-14028 cream of Amorepacific~     Corporation in patients with dermal pruritus.~   "
115752|NCT02052349|"~     This open label, Phase 1 study is to investigate the relative bioavailability of ABT-333 when~     delivered within different sites of the gastrointestinal tract in 12 healthy subjects.~   "
124441|NCT01938651|"~     This pilot clinical trial studies ultra-high field magnetic resonance imaging (MRI) and~     magnetic resonance spectroscopy (MRS) techniques in diagnosing breast cancer. New diagnostic~     procedures may be a more sensitive way to detect breast cancer.~   "
115739|NCT02052518|"~     This study is proposed on behalf of the Hartford Childhood Wellness Alliance, a 107 member,~     35 group organization whose goal is to improve the health of children in Hartford, CT. In a~     randomized control trial, the primary aim of this study is to test the initial efficacy of a~     program of enhanced home visitation with neighborhood and community support to change~     maternal behaviors related to infant nutrition (sweetened beverage/juice consumption,~     breastfeeding and introduction of solids), parenting skills (establishing routines around~     sleep, reading cues for hunger, satiety, television time) and family wellness (improving the~     home food environment, enhancing physical activity). The investigators hypothesize that at 12~     months of age, infants in the intervention arm will drink less sugar sweetened~     beverages/juices, will have ingested solids at an older age, will have been breastfed longer~     and more exclusively than infants in the control arm and will have less TV viewing, more~     established sleep routines and greater soothability (primary outcomes).~   "
115740|NCT02052505|"~     The purpose of this study is to investigate the effect of nurse-led medication reviews on the~     frequency, type and potential severity of PIP in psychiatric patients~   "
115741|NCT02052492|"~     Activated macrophages, present in excess during natural inflammatory responses, bear the~     potential to kill and eradicate cancer cells. Macrophage activation has been demonstrated to~     require the serum-borne vitamin D binding protein (known as Gc protein), as well as B and T~     lymphocytes. However, in various cancer patients the Gc protein is deglycosylated by serum~     α-N-acetyl galactosaminidase (Nagalase) secreted from cancer cells. This deglycosylated Gc~     protein, lacking the N-acetylgalactosamine monosaccharide, cannot be converted to its form of~     Macrophage Activating Factor, leading to immunosuppression rather than Macrophage activation~     against cancer cells.~      Efranat has developed cancer immunotherapy based on Macrophage Activating Factor produced~     from natural Gc protein extracted from FDA approved healthy human plasma.~      In this phase I study, the treatment is given as Intramuscular, once-weekly injection of~     EF-022, for two courses, while each course is comprised of 4 injections.~      The investigational treatment is expected to enhance immune response, thereby, improve~     patient's well being, quality of life and disease control.~      Primary objectives:~        1. To determine the safety and tolerability of EF-022 and to define the maximal tolerated~          dose (MTD) for potential administration.~        2. To identify the Dose Limiting Toxicity (DLT) of EF-022.~      Secondary objectives:~        1. To determine the 'Recommended Phase 2 Dose' (RP2D) based on MTD data, immunological and~          pharmacodynamics markers~        2. To explore preliminary efficacy of EF-022 in advanced solid tumors according to the~          'Response Evaluation Criteria in the modified Solid Tumors' (RECIST 1.1) and blood~          levels of tumor-related markers known to reflect tumor burden.~      Exploratory objectives:~        1. To assess levels of immune-related factors in peripheral blood (determined by FACS~          analysis), reflecting induced immunological activities, including but not limited to,~          natural killer (NK), monocytes (M1 and M2) and T cell subpopulations (effector vs~          regulatory, CD4+ and CD8+ cells), B cells (CD20), myeloid and dendritic cells etc.~        2. To assess the change in serum levels of protein biomarkers in the blood.~        3. To immunohistochemically assess and compare tumor derived tissue samples Pre and post~          treatment. To analyze the infiltration of different population of cells into the tumor~          bed.~   "
115742|NCT02052479|"~     The purpose of this research study is to see if there are differences between~     African-American and Caucasian girls with Polycystic Ovary Syndrome (PCOS) in how their~     bodies respond to a type of sugar, called glucose, the body's main source of energy. PCOS is~     one of the most common endocrine disorders among females. Features can include anovulation~     (eggs are not released from the ovaries) resulting in irregular menstrual periods, excessive~     amounts of androgenic (male) hormones resulting in acne and hirsutism (excessive hair growth~     on the face and body), and polycystic ovaries (small sac-like structures [cysts] on your~     ovaries) seen on ultrasound. Girls with PCOS also have higher levels of insulin in their~     bodies (called hyperinsulinism) but are not able to use insulin very well (called insulin~     resistance) resulting in an increased risk of diabetes. Diabetes is when you have high levels~     of glucose (sugar) in your blood. Many studies have looked at how bodies respond to glucose~     and have shown that compared to Caucasians, healthy African-Americans produce much more~     insulin (hyperinsulinism) but are not able to use it as well (insulin resistance) in~     childhood, adolescence, and adulthood. Insulin is a hormone that helps glucose move from the~     blood into the muscles for the body to use as energy. PCOS is associated with increased~     levels of insulin (hyperinsulinism) and not being able to use it as well (insulin~     resistance). So we want to see if there is a difference in insulin production (secretion) and~     insulin resistance between African-Americans and Caucasians girls with PCOS. To do this, we~     will look at blood glucose and insulin levels in response to giving glucose in~     African-American and Caucasian girls who have PCOS. The results of this study may ultimately~     help to more effectively target treatment therapy in individuals with PCOS that have~     increased insulin secretion and/or increased insulin resistance.~   "
115743|NCT02052466|"~     The hypothesis is that computer simulated bony impingement of the bone surrounding the~     spherical glenoid implant (the glenosphere) along the scapular neck on three-dimensional~     (3-D) computed tomography (CT) imaging analysis is predictive of the location of clinical~     scapular notching that develops following reverse total shoulder arthroplasty (TSA).~   "
115744|NCT02052453|"~     The purpose of this registry is to document incidence of electrical magnetic interference~     (EMI), change in programmed parameters or device related events in patients with Pacemakers~     (PM) and Implanted Cardioverter Defibrillators (ICDs) having surgery requiring~     electrocautery. A standardized perioperative device management protocol (ICD-ON Protocol)~     will be used.~   "
115745|NCT02052440|"~     Adult medical/surgical inpatient hospital care is more difficult and more expensive when~     complicated by alcohol dependency (AD), especially for patients who develop alcohol~     withdrawal syndrome (AWS). AWS can be mild, moderate or severe. The Severity of Ethanol~     Withdrawal Scale (SEWS) is tool used to assess severity and is the current standard of care~     for both monitoring and treating AWS at Denver Health. Moderate/severe AWS (i.e., SEWS ≥ 7)~     has important clinical implications and requires pharmacological treatment. At present, there~     are no safe and effective options for preventing AWS in at-risk inpatients. Baclofen is a~     GABA-B receptor agonist that has been used in the alleviation of spasticity in patients with~     multiple sclerosis since the 1970s. Baclofen has shown promise in the management of alcohol~     dependency in preclinical and clinical studies. We propose to examine baclofen in the~     prevention/amelioration of AWS in adult medical inpatients. The investigators hypothesize~     that Baclofen, as compared to placebo, will significantly reduce the number of adult~     inpatients with AD who will develop moderate/severe AWS (SEWS ≥ 7) when assessed at 72 hours~     after enrollment. Further the investigators hypothesize that Baclofen, as compared to~     placebo, will significantly reduce the need for symptom-triggered benzodiazepine~     administration during the 72 hours of hospitalization. These hypotheses will be tested in~     adult inpatients who are determined to be at risk for alcohol withdrawal and are subsequently~     placed on the SEWS monitoring and treatment protocol. These patients will be randomized to~     baclofen 10mg three times daily vs placebo.~   "
115746|NCT02052427|"~     This is a prospective, randomized, placebo-controlled, double blind safety and efficacy~     clinical trial.~   "
115747|NCT02052414|"~     To determine Gralise in treating fibromyalgia pain:~        -  efficacy~        -  safety~   "
115748|NCT02052401|"~     The purpose of this study is to determine whether a home visit by an Occupational Therapist~     is effective in reducing the rehospitalization rates in elderly patients after hospital~     discharge.~   "
115749|NCT02052388|"~     The purpose of this study is to determine the safety and efficacy of three different dosing~     regimens of brilacidin compared to daptomycin for the treatment of serious skin infections.~     This study will aid in selecting the appropriate dose of brilacidin for later stage studies.~   "
115756|NCT02052297|"~     This is a methodology study to examine the quantification of GSK2634673F binding in humans,~     with the aim of characterising a robust, non-invasive method to quantify the specific binding~     signal for the alpha(V)beta6 protein in human tissues. This will be the first time that this~     micro-dose ligand is administered to humans. The study will consist of three parts; Part A,~     Part B and Part C. Healthy subjects will be recruited into Parts A and B of the study in~     order to gain experience with the GSK2634673F positron emission tomography (PET) ligand and~     to optimise the scanning procedures prior to administration to IPF patients in Part C.~   "
115757|NCT02052284|"~     Extremely low birth weight infants have significant water loss through their skin immediately~     after birth. This significant fluid loss is because they have large amounts of fluids, have~     immature skin and large surface area. Loss of fluids is associated with many complications.~     The investigators hypothesize that application of sterile water to the skin of these infants~     is associated with decreased fluid requirements in the first week of life , improve skin~     integrity and decrease some complications of prematurity.~   "
115758|NCT02052271|"~     The purpose of this study is to determine whether transcranial cathodal direct current~     stimulation (tDCS) delivered over the cerebellum can improve essential tremor.~   "
115759|NCT02052258|"~     Opiate dependence is a serious problem, and oxytocin has many properties which make it~     attractive as a treatment for this type of substance dependence. This experiment will test~     the effects of oxytocin on a variety of brain-based processes in patients with opiate~     dependence. The investigators hypothesize that intranasal oxytocin in these conditions will~     enhance emotional processing and will have beneficial effects on stress responses in~     opiate-dependent patients.~   "
115760|NCT02052245|"~     This study aims for an in-depth characterization of human milk of mothers who delivered~     prematurely to decipher differences with milk of mothers who delivered at the expected term,~     with a particular focus on milk proteins~   "
115761|NCT02052232|"~     This is a randomized, double-blinded, crossover study to evaluate muscle protein metabolism~     during fasting and feeding in healthy older subjects.~   "
115762|NCT02052219|"~     The purpose of this study is to compare the effect of blisibimod plus standard of care versus~     placebo plus standard of care alone on the proportion of subjects achieving improvement in~     renal disease parameters.~   "
115763|NCT02052206|"~     The purpose of this study is to evaluate the accuracy of shoulder replacement surgery in~     realization a computer assisted 3D planning compared to conventional 2D planning.~   "
115764|NCT02052193|"~     The BRAF inhibitors dabrafenib and vemurafenib belong both two a new class of potent~     anti-cancer drugs and are highly efficacious in tumors harboring the BRAF V600E mutation.~     Both drugs seem to be equally efficacious; however, their toxicity profile seems to differ.~     Serious phototoxicity has been observed in ~ 30% of patients treated with vemurafenib and in~     ~2 percent of patients treated with dabrafenib. These phototoxic reactions have developed in~     spite of informing the patients of this possible adverse event and instructing them to~     protect themselves. Manifestation of phototoxic reactions depends on the patient's habits of~     exposure and their efforts to protect themselves. The true frequency of photosensitivity can~     only be established by systematic photo-testing. In dermatology, standard test procedures~     with different UV-wavelengths and dosages have been established and the primary goal of this~     study will be to clarify the true rate of photosensitivity by these two BRAF-inhibitors.~     Furthermore, systematic experience will be collected how to best protect patients from~     phototoxic events. Dabrafenib and Vemurafenib are commercially available and considered~     standard of care for BRAF mutant metastatic melanoma in Germany. As the number of patients~     will not allow any conclusion with regard to efficacy or safety of vemurafenib, patients~     randomized to vemurafenib in part 2 will only remain on study until completion of~     phototesting.~   "
115765|NCT02052180|"~     The purpose of this study is to demonstrate improved pain control and outcomes in wrist~     operations with the use of a long-acting local anesthetic, EXPAREL, when compared to the use~     of the standard local anesthetic, Marcaine.~   "
115766|NCT02052167|"~     This study is planned to evaluate the human factor (HF)/usability of pediatric or adolescent~     JIA patients and the caregivers of Juvenile Idiopathic Arthritis (JIA) patients with the~     Methotrexate Prefilled Pen (including a label comprehension assessment and a device~     robustness evaluation).~   "
115767|NCT02052154|"~     Evaluate the immunogenicity of an innovative pneumococcal vaccination strategy in~     splenectomized adults comprising 1 dose of Prevenar13® conjugate vaccine (PCV) at M0 followed~     by 1 dose of Pneumo23® or Pneumovax® polysaccharide vaccine (PPSV) at M2. Duration of~     follow-up of 36 months.~      The main endpoint will be the proportion of subjects responsive to 9 of the 13 serotypes~     common to the PCV and PPSV vaccines, selected because of their frequency in invasive~     infections in adults in France and their potentially reduced susceptibility to penicillin~     (serotypes 1, 3, 6A, 7F, 9V, 14, 19A, 19F, 23F).~   "
115768|NCT02052141|"~     Primary Objective - To assess the relative efficacy of two dose levels of CINRYZE (500 Units~     and 1000 Units) administered by intravenous (IV) injection every 3 or 4 days to prevent~     angioedema attacks in children 6 to 11 years of age with hereditary angioedema (HAE).~      Secondary Objectives - To assess the safety and tolerability, characterize the~     pharmacokinetics (PK) and pharmacodynamics (PD), and assess the immunogenicity of two dose~     levels of CINRYZE administered by IV injection in children 6 to 11 years of age with HAE.~   "
115769|NCT02052128|"~     This is a multi-center, open-label, randomized, parallel group two-stage phase 1 study with a~     phase 2 expansion component in pts with recurrent or metastatic APRpos uterine endometrioid~     adenocarcinoma. Stage 1: Six dose cohorts, 5 using the extended release tablet (ER)~     formulation (10 mg BID, 20 mg BID, 30 mg BID, 40 mg BID, 50 mg BID) and 1 using the~     immediate-release (IR) tablet formulation 100 mg QD will be randomized in parallel. After~     enrollment of 36 patients in Stage 1, a dose of 50 mg BID was determined to be the RP2D.~     Stage 2: An additional 10 patients with recurrent or metastatic APRpos uterine endometrioid~     adenocarcinoma (Stage 2a) will be enrolled at the RP2D. Based on the response in Stage 2a,~     the cohort will be further expanded by up to 19 more patients to a total of 29 patients to~     confirm the efficacy and safety profile of onapristone in this selected patient population~     (Stage 2b).~   "
124662|NCT01935713|"~     The overall aim of the current study is to determine if the use of nicotine containing~     products by caregivers who smoke and who are not interested in quitting, is effective in~     reducing children's secondhand smoke exposure.~   "
115770|NCT02052115|"~     Overweight and physically inactive breast cancer survivors are at increased risk of breast~     cancer recurrence and mortality. Cancer treatment-related changes that likely mediate weight~     loss and exercise success include the long term effects such as fatigue, psychological~     distress and impaired executive (cognitive) function.~      This study will explore the variability in how breast cancer survivors respond to a~     behavioral weight loss intervention. The primary objectives include determining the degree to~     which success with a behavioral weight loss intervention in overweight breast cancer~     survivors is explained by measures of executive function as measured with task performance at~     6 and 12 months and associated brain function imaging (fMRI), collected at baseline~     only.Additionally, the study is designed to determine the degree to which selected measures~     of cancer-related symptoms account for variance in the success of breast cancer survivors at~     6 and 12 months following entry into a behavioral weight loss and exercise intervention.~   "
115771|NCT02052102|"~     The study hopes to determine whether patients with left-sided breast cancer are at an~     increased risk of cardiac changes due to radiation to the breast +/- Anthracycline-based~     chemotherapy +/- Herceptin and whether a deep inspiration breath hold (DIBH) technique during~     radiotherapy treatments would further reduce dosimetric dose to the heart as compared to the~     conventional free breathing (FB) technique thus reducing cardiac toxicity as measured by~     cardiac MRI using left ventricular end-diastolic volume (LVEDV) as a metric. Bio fluid~     samples will also be collected to investigate specific biomarkers of breast cancer: BNP,~     PIIINP and CITP~   "
115772|NCT02052089|"~     The purpose of this study is to find the optimal treatment method for chronic lateral~     epicondylosis, and focused on the 'healing mechanism' and 'pain modulation' of degenerated~     tendon.The hypothesis is that there will be significant difference between treatment groups~     and control group (physiotherapy) and also there will be significant difference among~     treatment groups.~   "
115773|NCT02052076|"~     In this study we will compare the health effect of two different meal patterns. In one~     subjects will consume food according to an 'irregular meal pattern' (3-9 meals/day) and the~     other 'regular meal pattern' (6 meals/day) for two weeks. The energy requirement of the~     subjects will be calculated to maintain body weight during the study. Participants will be~     provided with all the food to be consumed during the study. Initially, subjects will attend a~     screening visit in which they will complete questionnaires on medical health, eating habits~     and physical activity. Height, weight and waist circumference will be measured at this visit.~     Thereafter, subjects will be assigned to a 2-wk period following one of the two~     meal-patterns. There will be a 2-week period between the two interventions when subjects will~     consume their normal diet and at the end of this, participants will undertake the next meal~     pattern. During the two phases participants will be asked to wear an armband, which detects~     movement and measures heat loss, to assess their energy expenditure and a blood glucose~     monitoring device will be worn for three days. Before and after each 2-week intervention,~     subjects will come to the lab and will be given a test drink and blood samples will be~     obtained to evaluate the health effects of the meal patterns. Energy expenditure will be~     measured by indirect calorimetry. They will then be offered an ad-libitum meal and be asked~     to eat until they feel comfortably full. During each of the 2-week periods, participants will~     be asked to record their food intake and record their appetite sensations on specific days.~   "
115774|NCT02052063|"~     The stapled transanal rectal resection (STARR) has recently been recommended for patients~     with obstructed defecation syndrome (ODS) caused by rectocele and rectal wall~     intussusception.~      The aim of STARR is to correct the mechanical outlet obstruction using a stapler device for~     endorectal resection of the distal rectum.~      This technique significantly improves constipation. However, there are several reports of~     new-onset faecal incontinence after STARR and urgency has been identified as the major~     side-effect of this procedure.~      Although this technique has become an important surgical option in the treatment of~     obstructive defaecation syndrome, its impact on continence can be problematic and objective~     data about parameters that predict its result are not yet available One study evaluated the~     anal function after surgery in 30 patients. In this study, urgency or incontinence was~     complained by 26% of patients. No sonographically demonstrable sphincter fragmentations were~     noticed in the endoanal exam performed at the follow-up.~      No significant difference was observed in anorectal manometry. Even if data are not~     statistically significant, resting and squeezing pressures are lower in those patients not~     satisfied.~      Currently, anal canal pressure measurements using ano-rectal manometry are the most common~     means of assessment of sphincter function. Some studies have been looking at the concept of~     distending sphincter regions as a better measure of its performance.~      The functional lumen imaging probe (FLIP) is a novel technique which has the ability to~     provide real-time images of the function of human gastrointestinal sphincter during~     distension. This distensibility technique provides an important new way of studying the anal~     canal and hence may have a role in testing sphincter competence in patients with disorders~     after STARR procedure.~      Twenty-eight patients will be enrolled in this study over a period of 36 months.~      Preoperative assessment will include~        -  clinical examination~        -  the Wexner Incontinence Score and the Faecal Incontinence Quality-of-Life Index (FIQL)~          to rate anal incontinence~        -  video defecography, anorectal manometry, anal ultrasound (AUS) and measure of anal~          sphincter distensibility using endoFLIP Follow-up evaluation will scheduled for 3 months~          after surgery, and will include symptom evaluation (using the same standard~          questionnaires for incontinence), clinical examination and investigation using anal~          ultrasound and endoFLIP.~      If we demonstrate that this surgical technique can cause anal lesions with decreased~     sphincter competence, this may lead to a modification of the surgical technique especially in~     patients at risk of developing postoperative anal incontinence.~   "
115775|NCT02052050|"~     The purpose of this study is to determine the effects of physical training program to improve~     deep stabilizer muscle in colorectal cancer survivors~   "
115776|NCT02052037|"~     We propose a prospective, randomized, single-blind controlled crossover study to assess the~     effects of daily egg inclusion versus egg exclusion, on glycemic control, anthropometric~     measures, and overall diet quality in adults with Type 2 diabetes.~   "
115777|NCT02052024|"~     The present pilot study is designed to assess the extent to which BOTOX and MYOBLOC cause~     muscle atrophy in spastic patients. The primary objective is to assess whether there is~     statistically significant difference in muscle atrophy between the two groups over a one year~     period.~   "
115778|NCT02052011|"~     The purpose of this study is to determine the effectiveness of Ranolazine for the treatment~     chest pain from disease of small vessels of the heart also known as 'microvascular angina'.~   "
115872|NCT02050789|"~     Resident duty hour requirements in the U.S. are still evolving as stakeholders continue to~     debate how best to (re)structure postgraduate medical education.~      There is concern that current restrictions may be detrimental to patient care and resident~     training. To investigate these issues, the investigators will be conducting a one-year,~     prospective randomized trial to examine how flexibility of duty hour requirements affects~     patient care when compared to current resident duty hour requirements. Further information~     about the study is available on the FIRST Trial website http://www.thefirsttrial.org/.~   "
115873|NCT02050776|"~     The purpose of this study was to study the effect of stem cell therapy on the course of the~     disease in patients with Limb Girdle Muscular Dystrophy.~   "
115779|NCT02051998|"~     Age-related macular degeneration (AMD) is the leading cause of irreversible blindness in~     industrial countries. In the late stages of the disease, neovascular changes or the~     development of geographic atrophy (GA) may induce severe visual loss. GA is characterized by~     the development of areas of outer retinal atrophy with continuous spread over time that is~     corresponded to an visual field defect for the patient. The pathogenesis is still~     incompletely understood. Despite the break-through in the treatment of neovascular AMD by~     intravitreally administrated vascular endothelial growths factor (VEGF) inhibitors, there is~     yet no treatment available to slow down or halt the disease process in GA. We and others have~     demonstrated that the total GA area progression shows large differences between patients.~     Potential factors influencing differential progression have been intensely studied: While~     neither systemic nor genetic factors have been shown to influence GA progression, ocular~     characteristics such as GA baseline size or phenotypic features of fundus autofluorescence~     (FAF) abnormalities have been identified as risk characteristics for increased GA~     progression. While these previous studies have mainly focused on the characterization of~     total GA area progression, topographic directional spread has not been analyzed and relevant~     predictive markers are yet unknown. There may be large differences in the local GA~     progression. The primary objective of this study is to identify specific characteristics, for~     the local GA progression. The knowledge of such risk factors may help to better understand~     the pathogenesis of GA. The identification of predictive markers will allow for better~     prognostic assessment of the individual disease process. The DSGA study is the extension~     trial of the FAM (Fundus Autofluorescence in Age-related Macular Degeneration) study~     (NCT00393692).~   "
115780|NCT02051985|"~     The purpose of this study is to evaluate the feasibility and the short-term effects of an~     early-start aerobic exercise training program on functional capacity, symptoms and~     neurohormonal activation in chronic heart failure patients with recent acute hemodynamic~     decompensation.~   "
115781|NCT02051972|"~     The objective of the study is to confirm clinical performance and safety of the Nanostim~     leadless cardiac pacemaker system within its intended use and according to its instructions~     for use.~   "
115782|NCT02051959|"~     -  Phantom limb pain (PLP) refers to pain in a limb that has been amputated or~          deafferented. Phantom limb pain might be related to brain cortical plastic changes.~        -  The purpose of this study is to determine the efficacy of a series of transcranial~          direct current stimulation (tDCS) sessions, a non-invasive and focal brain stimulation~          method, in producing long-term reduction of phantom limb pain among amputees who~          experience such pain.~      This is a Crossover sham control.~   "
115783|NCT02051946|"~     The purpose of this study is to identify whether or not injection of a study drug (ethacrynic~     acid) using the investigational Retroject device is able to lower eye pressures in patients~     with advanced glaucoma. 20 patients with advanced glaucoma with visual acuity less than~     20/200 and intraocular pressures (IOP) >20mmHg on maximum medical therapy will be asked to~     participate in the study. The first five patients will have the Retroject device placed over~     their eye for 30 seconds and then removed. Assuming no issues, then it will be placed on the~     eye for one minute. The second group of patients (3 total) will have the Retroject device~     placed on the eye and then an injection of ethacrynic acid into the episcleral vein. The~     third group of patients (12 total) will have the Retroject device placed on the eye and then~     will be randomized in a 2:1 ratio to receive either an ethacrynic acid injection or a~     balanced salt solution injection. All 20 patients will then return for intraocular pressure~     measurements on days 1, 2, 3, and 7 as well as 6 weeks after injection. In addition, the~     patients will undergo pre and post intervention corneal endothelial assessments (endothelial~     cell count, shape analysis, and pachymetry). Potential safety issues are unlikely and include~     bleeding, infection, pain, ototoxicity, or temporary or permanent loss of vision.~   "
115784|NCT02051933|"~     The purpose of this study is to determine if botulinum toxin type A (Botox) injections, at~     the time of surgery for pilon fractures, will improve ankle range-of-motion and~     functionality.~   "
115785|NCT02051920|"~     Since 20 years, the techniques of direct measurement of cardiac stiffness in the diagnosis of~     myocardial diseases do not exist.~      We propose a human study evaluating the direct measurement of cardiac ultrasound stiffness by~     elastography.~      This study will include 30 patients with cardiac disease whose rigidity varies with~     underlying disease.~      The purpose of this study is to evaluate the stiffness during open heart surgery.~   "
115786|NCT02051907|"~     The main purpose of this study is to demonstrate the safety and efficacy of KAM1403 GEL in~     reducing the symptoms of mild to moderate Radiation Dermatitis. Efficacy will be evaluated by~     comparing symptoms assessment during and post radiotherapy: erythema, desquamation, edema,~     moist desquamation and ulceration in the KAM1403 Gel treated group versus a group of subjects~     treated with the Aloe vera Gel (the control group). In addition, a comparison will be made~     between subjects' self evaluation in the treatment group versus the control group. Safety~     will be determined by the number and severity of Adverse Events Device-Related.~   "
115787|NCT02051894|"~     1 in 1000 babies are born suffering from a lack of oxygen. This is known as hypoxic ischemic~     encephalopathy (HIE). Infants with this condition can suffer multiple organ problems. In~     particular it can affect how their hearts pump blood around their body thus leading to a poor~     blood supply to parts of their body such as the brain. This is known as circulatory failure~     and can contribute to poor long term outcomes such as cerebral palsy. To try and prevent~     brain damage these infants are treated with total body cooling, however this treatment can~     further effect how babies pump blood around the body, but also how drugs which may be used by~     in this condition are processed.~      In order to assess and treat this condition doctors need to be able to accurately measure the~     blood supply in an infant. However there is no agreement on how best to do this. This makes~     decisions about when to treat an infant difficult. Sometimes doctors may want to use drugs~     such as dobutamine or adrenaline but these drugs are unlicensed in babies.~      This study proposes to observe the way babies circulatory problems are treated in babies with~     HIE the in the first four days of life. In addition the study will look are two new~     measurements of a babies blood supply to see if they are a better measure of when an infant~     needs treatment. This will involve an ultrasound scan of the heart and measurement of the~     baby's oxygen levels from a probe placed on their hand. The study will also look at how the~     drug dobutamine is processed by babies. This will be done from two small extra blood tests.~     The aim of the study is to help clinicians refine the identification and treatment of~     circulatory failure in babies with HIE.~   "
115885|NCT02050620|"~     Using an observational prospective design, potential subjects will be identified and screened~     for eligibility via medical record review of breast cancer patients scheduled for radiation~     therapy at Duke Radiation Oncology Clinic. Subjects who agree to participate will be asked to~     complete study questionaires prior to the start of radiation therapy and again during the~     last week of therapy.~   "
115788|NCT02051881|"~     Investigating which receptors are involved in nutient sensing of enteroendocrine cells and on~     nerve endings, gives further knowledge on the kind of nutrients responsible for the secretion~     of gut hormones involved in satiety signalling. So far only little is know about the~     distribution of potential nutient sensing receptors along the gastrointestinal tract. The~     investigators are interested in the intestinal parts which highly secrete CCK and GLP-1. By~     comparing these tissues, it is expected to further elucidate which receptors are important~     for satiety signalling in the intestine.~      Having this information gives rise to further reseach on how these receptors stimulate the~     secretion of gut hormones. Moreover, knowing which receptors are involved in satiety~     signalling, gives oppertunity for targeting these receptors to increase satiety and~     influencing food intake.~      The investigators aim to investigate the distribution of the above mentioned receptors, in~     the following referred to as 'nutrient sensing receptors', which have been suggested to be~     involved in satiety signalling, throughout the intestinal tract. For these receptors the gene~     expression, localisation and protein expression will be determined at different locations.~     This will be measured in intestinal mucosal biopsies of two locations in the duodenum, in the~     terminal ileum, the ascending colon, the transverse colon and the descending colon.~   "
115789|NCT02051868|"~     Anal cancer is a relatively uncommon disease and there is currently no standard chemotherapy~     treatment for patients with inoperable locally recurrent or metastatic disease. The aim of~     this phase II study is compare two well known and largely used chemotherapy regimens -~     Cisplatin plus 5-fluorouracil vs Carboplatin plus Paclitaxel. The result of this study will~     set a standard of care for this disease and provide useful information for future Phase III~     trials.~   "
115790|NCT02051855|"~     Circulatory failure can affect up to 50% of premature infants that are admitted to neonatal~     intensive care. This can be because their heart muscle is not developed enough to send blood~     to vital organs such as the brain. This can lead to severe short term problems such as kidney~     failure and contribute to poor long term development such as cerebral palsy. In addition~     babies born too early may need more time to adapt from a circulation that relies on the~     placenta in the womb to one that is self sufficient.~      Doctors need to be able to accurately measure the blood supply in an infant. However there is~     no agreement on how best to do this. This makes decisions about when to treat an infant~     difficult. Doctors may use drugs such as dopamine or dobutamine to help a babies circulation.~     However these drugs have not been tested properly in babies older than 33 weeks gestation.~      This study proposes to observe the way babies older than 33 weeks circulatory problems are~     treated in the first three days of life. In addition the study will look at two new~     measurements of a babies blood supply to see if they are a better measure of when an infant~     needs treatment. This will involve an ultrasound scan of the heart and measurement of the~     child's oxygen levels from a probe placed on their hand or leg. The study will also look at~     how the drug dobutamine is processed by babies. This will be done from two small extra blood~     tests. The aim of the study is to help clinicians refine the identification and treatment of~     circulatory failure in premature babies.~   "
115791|NCT02051842|"~     Oxidative stress is produced by imbalance between reactive oxygen species and antioxidant~     systems. This state is frequently associated with chronic diseases like obesity, insulin~     resistance, metabolic syndrome and hepatic steatosis. In the liver, the oxidative stress may~     trigger the progression of fatty liver disease, from triglyceride accumulation to~     inflammation, cirrhosis and hepatocellular carcinoma. Thus, the attenuation of oxidative~     stress, could be an important therapeutic target to lessen the severity of the disease. Until~     now, there is not a medical treatment to cure non-alcoholic fatty liver disease, but~     therapies aimed at reducing oxidative stress have been proposed. Metadoxine, an ionic complex~     of pyridoxine-pyrrolidone molecule, acts as a synthetic antioxidant, forming traps that can~     reduce free radicals; likewise, metadoxine has a proven capacity to reduce fat liver in~     alcoholic hepatitis. Finally, in fact that alcoholic and non-alcoholic liver diseases share~     molecular mechanisms in the generation of oxidative stress, the investigators propose~     metadoxine as a posssible modifier of the oxidative stress in non-alcoholic liver disease,~     prediabetic patients.~   "
115792|NCT02051829|"~     Comparison of preoperative screening score for OSA. In a preoperative population, comparison~     of the STOP-BANG, DES-OSA, P-SAP and OSA50 score.~   "
115793|NCT02051816|"~     Respiratory failure requiring endotracheal intubation occurs in as many as 40% of critically~     ill patients. Procedural complications including failed attempts at intubation, esophageal~     intubation, arterial oxygen desaturation, aspiration, hypotension, cardiac arrest, and death~     are common in this setting. While there are many important components of successful airway~     management in critical illness, the maintenance of adequate arterial hemoglobin saturation~     from procedure initiation until endotracheal tube placement is paramount as desaturation is~     the most common factor associated with peri-intubation cardiac arrest and death.~     Interventions that either shorten the duration of time required for tube placement or prolong~     the period before desaturation may be effective in improving outcome. The high rate of~     complications and the lack of existing evidence regarding the efficacy of current airway~     management techniques in shortening the time to airway establishment or prolonging the time~     to desaturation mandates further investigation. The primary hypothesis is that video~     laryngoscopy will be superior to direct laryngoscopy in successful first attempt at~     endotracheal intubation (defined by confirmed placement of an endotracheal tube in the~     trachea during first laryngoscopy attempt) of medical ICU patients by Pulmonary/Critical Care~     Medicine fellows after controlling for the operator's past number of procedures with the~     equipment used. Also, the investigators hypothesize that the provision of apneic oxygenation~     during the endotracheal intubation procedure (defined as a nasal cannula with 15 liters per~     minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until~     after completion of the procedure) will result in a higher arterial oxygen saturation nadir~     (defined as lowest noninvasive oxygenation saturation value observed between the~     administration of sedation and/or neuromuscular blockade and 2 minutes after successfully~     secured airway or death) compared to no apneic oxygenation.~   "
115794|NCT02051803|"~     The long-term goal of this program of research is to develop and disseminate an efficacious~     intervention for weight concern that will significantly increase smoking cessation rates~     among women. The overall objective of this project is to develop this intervention and modify~     it based on piloting and feedback to ensure its feasibility and acceptability. These~     objectives will be accomplished by pursuing the following specific aim: 1) develop a~     group-based distress tolerance treatment for weight concern (DT-W) in female smokers and a~     comparison health education (HE) program and pilot both treatments with three groups of 10~     (total N = 30) female weight-concerned smokers (2 DT-W groups, 1 HE group).~   "
115795|NCT02051790|"~     This study is designed to evaluate the agreement between florbetapir F 18 scan interpretation~     in the clinic and by expert readers.~   "
115796|NCT02051777|"~     To investigate the effect of different strategies for managing malnutrition in the community~   "
115800|NCT02051725|"~     -  Aging is associated with a progressive and generalized deterioration of physiologic~          systems and greater incidence of chronic conditions, which ultimately translates into~          functional impairment, disability and dependency.~        -  Physical activity and exercise have been recognized as key pillars for the management of~          chronic diseases in support of medical treatment, and essential to increase physiologic~          function, but there is only limited evidence indicating increased physical function,~          following exercise interventions. One of the greatest challenges in the science of aging~          and exercise is to understand whether and to which extent exercise and active life-style~          may postpone the onset of disability and/or reverse physical impairments.~        -  Maintenance/improvements of physical function and mobility should be considered as~          primary targets for independent living, active engagement in societal challenges, and,~          more in general, when promoting active ageing.~        -  The aim of this study is to collect preliminary data to identify the feasibility and~          sustainability of an active life-style intervention in older adults with reduced~          mobility receiving a preventive home visit from the public health care authority.~        -  This study will represent the base for a larger phase III parallel group study~          implemented in the public health care setting, with the specific aim of improving~          physical function and delay the onset of functional impairment in older adults.~   "
115801|NCT02051712|"~     The aim of the study is I. To assess whether an individualized exercise training program is~     superior as compared to usual care with respect to exercise tolerance, II. to assess whether~     intervention tools that aim to increase exercise adherence are superior to an individualized~     exercise training alone with respect to exercise tolerance and long-term effects, and III. to~     identify biomarkers that that may be implemented into novel intervention tools aiming to~     increase exercise adherence in patients with chronic heart failure.~   "
115802|NCT02051699|"~     The purpose of this study is assess the severity of osteoarthritic knee between one-leg and~     both-leg standing radiograph in primary OA knee~   "
115803|NCT02051686|"~     This study is investigating the use of tranexamic acid (TXA) in patients with pelvis and/or~     hip socket fractures that require surgery. TXA is FDA-approved in patients with hemophilia~     for short-term use to reduce hemorrhage and the need for replacement blood during tooth~     extraction. However, it has also been used extensively in severely injured patients after~     major trauma and during elective hip and knee replacements. Previous studies indicate TXA may~     reduce blood loss and the need for blood transfusions while being safe for use in most~     patients. TXA is fairly inexpensive and easy to obtain.~      The purpose of this study is to determine if TXA will make surgery in patients with pelvis~     and/or hip socket fractures safer and more cost efficient.~   "
115804|NCT02051673|"~     Four subjects were treated under compassionate use provisions under this study with~     facilitating cell therapy (FCRx)~   "
115805|NCT02051660|"~     Purpose of this randomized controlled trial is to test the efficacy of the individual~     psychotherapeutic intervention Managing Cancer and Living Meaningfully (CALM) in a German~     sample of patients with advanced cancer. The interventions aim is to reduce depression and~     distress and support psychological well-being.~   "
115806|NCT02051647|"~     To investigate whether copeptin levels increase upon a psychological stress (i.e. written~     examination) and whether copeptin levels measured immediately before the written examination~     predict success of the examination.~   "
115807|NCT02051634|"~     The purpose of this research study is to explore the effects of fermented papaya preparation~     (FPP) on whole body inflammation, physical function, fatigue, and health-related quality of~     life. The investigators will conduct a double-blind, randomized, placebo-controlled pilot~     study on FPP in older adults. If FPP is found to have a beneficial impact on systematic~     inflammation in this study population (adults aged 70-100 years old), then this supplement~     may be a potential treatment option to combat aging.~   "
115808|NCT02051621|"~     Ablation of the cavotricuspid isthmus (CTI) in the right atrium is currently the therapy of~     choice for the treatment of typical atrial flutter (3,4). It is a curative approach and has a~     high success rate (5). It has been recognized that patients with typical atrial flutter often~     complain of atrial fibrillation (1,2). Current clinical and experimental studies confirm the~     close relationship between atrial flutter (AFL) and atrial fibrillation (AF) and raise a~     question, if both arrhythmias are different forms of a common electrical phenomenon with~     atrial fibrillation being the underlying clinical problem (6).~   "
115809|NCT02051608|"~     Part 1 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study~     will evaluate the efficacy and safety of gantenerumab in participants with mild Alzheimer~     disease. Participants will be randomized to receive either gantenerumab subcutaneously every~     4 weeks or placebo subcutaneously every 4 weeks. Approved Alzheimer medication is allowed if~     on stable dose for 3 months prior to screening. Part 2 is an open-label extension (OLE).~      A positron emission tomography (PET) imaging substudy will be conducted within the main~     study. Eligible participants who provide separate informed consent will undergo PET imaging~     scans using the radioligand florbetapir as a pharmacodynamic measure of changes in brain~     amyloid load over time.~   "
115810|NCT02051595|"~     Antibiotics are routinely used to prevent surgical wound infection. Vancomycin is a widely~     used antibiotic for surgery in patients with an allergy to penicillin. During cardiac~     surgery, cardiopulmonary bypass (CPB) and modified ultrafiltration (MUF) are routinely used~     and can lower the level of the antibiotic. The purpose of this study is to quantify the~     change in plasma vancomycin concentration associated with cardiopulmonary bypass and modified~     ultrafiltration.~   "
115811|NCT02051582|"~     Thirty (30) orthopaedic surgeons from the University of Florida Department of Orthopaedics~     and Rehabilitation will be recruited and enrolled in the study to determine whether having a~     laser pointed on a fluoroscopy machine can significantly decrease the amount of radiation~     exposure as measured while obtaining multiple views during surgery as well as decrease~     radiation exposure and time to accomplish the goals of surgery.~   "
115909|NCT02050308|"~     The purpose of this study is to test the effectiveness of a culturally-tailored~     Internet-based program that helps American Indian (AI) tribal college students quit smoking.~   "
116938|NCT02036892|"~     Patients with Type 2 Diabetes randomly allocated to the intervention arm (health coaching +~     smartphone-based health promotion software) will have significantly better Hemoglobin A1c~     levels at 6 months post-intervention than patients with Type 2 Diabetes allocated to the~     control arm (health coaching alone).~   "
115812|NCT02051569|"~     Rationale: Poor social functioning may contribute to major depressive disorder (MDD). Poor~     serotonin function may also contribute to MDD. Recent research suggests that serotonin plays~     a role in regulating human social behaviour. Therefore it would be intriguing to investigate~     the role of serotonin in regulating the quality of everyday social interactions in a~     population at risk for MDD. Human social behaviour can be reliably assessed in everyday life~     using Ecological Momentary Assessment (EMA).~      Objective: This study aims to investigate how an experimental increase in serotonin~     influences social functioning in healthy adults with a first-degree family member diagnosed~     with MDD. The primary goal is to investigate the role of serotonin in regulating everyday~     social behaviour, measured using EMA. This will be done using oral supplementation with~     tryptophan, the amino acid precursor of serotonin. Secondary goals are to determine how this~     experimental manipulation influences people's feelings as well as their perceptions of~     other's social behaviour following interpersonal events, and social cognitions at the end of~     the day. An exploratory goal is to investigate if these effects are moderated by genes~     thought to be involved in MDD.~      The primary hypothesis to be tested is that tryptophan will reduce quarrelsome behaviour.~   "
115813|NCT02051556|"~     Freezing of gait (FOG) is a disabling episodic gait disturbance that is common among patients~     with Parkinson's disease (PD). The symptoms of PD generally show an asymmetric onset and~     progression.~      In particular, impairments in rhythmicity, symmetry, and bilateral coordination have been~     reported to be associated with FOG episodes. As the maintenance of gait depends on the~     precise alternating movements of both legs, irregularities in rhythm, symmetry, and bilateral~     coordination may impair gait sequence, potentially causing freezing.~      Results of recent studies strongly suggest that bilateral uncoordinated gait and marked gait~     asymmetry are associated with FOG. Moreover, it has recently been hypothesized that this may~     lead to a degree of asymmetric motor function, and that FOG in parkinsonian patients is~     triggered by a breakdown in the bilateral co-ordination underlying the normal timing of gait.~     Aim of the study was to evaluate how the modulation of asymmetry through physical therapy~     might improve gait and FOG.~   "
115814|NCT02051543|"~     Insomnia is a highly prevalent condition and costly national public health problem and a~     transdiagnostic risk factor for the development of a number of internalizing/emotional~     disorders, as well as associated functional impairment. Interestingly, sleep treatments~     appear to reduce anxiety and depression in addition to improving sleep. Given the substantial~     individual and societal costs of insomnia and associated mental illness, there is an urgent~     need to better understand the mechanism through which sleep treatments improve daytime~     symptoms of depression and anxiety in order to enhance the efficacy of sleep treatments and~     ultimately prevent the development of depression and anxiety disorders following the onset of~     insomnia. Research suggests that sleep disruptions lead to emotional dysregulation, including~     increased negative affectivity and decreased positive affectivity. This affective reactivity~     may ultimately be related to the development of depression and anxiety. Despite the apparent~     link between sleep and emotion regulation, studies have not investigated the influence of~     sleep treatment on these affective dimensions. The investigators long term goal is to~     increase understanding of the mechanism of action in sleep treatments in relation to changes~     in positive and negative valence systems. The investigators immediate objective is to conduct~     a pilot study investigating changes in mean levels and day-to-day instability of affective~     dimensions following a brief behavioral intervention for insomnia tailored for veterans~     (Brief Behavioral Treatment for Insomnia-Military Version. The specific aims include~     developing a deeper understanding of the effects of behavioral sleep treatment on positive~     and negative valence systems and testing a model in which affective reactivity modulates the~     relation between sleep and internalizing symptoms. Both objective and subjective sleep data,~     as well as measures of affective states and depression/anxiety symptoms, will be collected~     pre and post-treatment in order to examine changes in sleep, affect and daytime symptoms over~     the course of treatment and to test a model in which affective changes mediate the relation~     between improvements in sleep and improvements in depression and anxiety. The investigators~     hypothesize that sleep treatment will improve sleep, daytime symptoms and affective~     reactivity and that changes in affect will mediate the relation between sleep and~     internalizing symptoms.~   "
115815|NCT02051530|"~     Rationale: Major depressive disorder (MDD) is a psychiatric disorder whose onset, severity,~     and duration are influenced by interpersonal factors. The serotonin system is known to~     influence MDD risk. Recent research has suggested that serotonin may also play a role in~     regulating social behaviour. Therefore, it would be interesting to study the role of~     serotonin in responses to social stimuli in individuals at risk for MDD.~      Objective: This project aims to study how changes in serotonin alter interpersonal~     functioning in adults with or without a first degree family member diagnosed with MDD. The~     primary goal is to investigate the effect of experimentally lowered brain serotonin levels on~     empathic accuracy. Secondary goals are to determine how this manipulation influences verbal~     and non-verbal communication, cardiovascular function in a social context, and mood. An~     exploratory goal is to investigate how these outcomes are related to genes thought to be~     involved in MDD.~   "
115816|NCT02051517|"~     The aim of this study is to expand the understanding of the vitreous, its solute chemistry,~     and the normal relationship of that chemistry to the chemistry of the systemic circulation in~     humans.~      Sample human vitreous from patients undergoing vitrectomy surgery and compare to results of~     metabolic chemistry panel from subject.~      Allow the research team to extract .2ml sample of the .5ml - 1.0ml vitreous that is normally~     extracted during a routine undiluted vitreous biopsy, a standard procedure performed for~     various indications. Blood draw for metabolic chemistry panel (1-2 ml).~   "
115817|NCT02051504|"~     Most of the studies concerning aerobic fitness in Type 1 diabetic patients noted a~     relationship between impaired aerobic fitness and high glycated haemoglobin (HbA1c) levels,~     reflecting poor long term glycaemic control. To explain this relationship, the indirect~     effect of chronically high blood glucose levels on cardiovascular complications - and hence~     on exercise cardiovascular adaptations - are often mentioned. However, one could wonder if~     HbA1c could also have a direct impact on aerobic fitness patients with Type 1 diabetes.~     Haemoglobin glycation may increase its O2 affinity, thus limiting the O2 availability at the~     muscular level and impairing maximal aerobic power. Moreover, chronic hyperglycaemia might~     have deleterious effect on muscle mitochondrial capacity to use O2. The aim of this study is~     to assess the effect of Type 1 diabetes and of HbA1c level on muscular oxygen delivery and~     use and hence on aerobic fitness.~   "
115818|NCT02051491|"~     In preterm infants, endotracheal mechanical ventilation is well known to cause various forms~     of lung injury including volutrauma, barotrauma and oxytrauma - collectively known as~     ventilator-induced lung injury (VILI). As such, there is a move towards non-invasive~     ventilation (NIV) in recent decades. However, many infants placed on NIV modes fail and~     require intubation. A relatively recent mode of NIV is non-invasive high frequency~     ventilation (NIHFV). Studies on this modality are scarce, but do suggest that neonates can be~     ventilated effectively. However, its efficacy in comparison with other existing modes of NIV~     remains unknown due to lack of appropriate studies. The investigators hypothesize that NIHFV~     is a superior NIV mode than Biphasic Nasal Continuous Positive Airway Pressure (BP-NCPAP) in~     preterm infants in preventing intubation following NCPAP failure.~   "
115820|NCT02051465|"~     Colorectal cancer accounted for 142,570 new cancer cases and 51,370 cancer deaths in USA in~     2010 and worldwide has become the third most common cancer and second leading cause of cancer~     related deaths. Colonic adenomatous polyps are known precursors of colorectal cancer and~     endoscopic removal of the polyps prevents development of colon cancer.~      Removal of such large polyps requires special endoscopic techniques-endoscopic mucosal~     resection (EMR) and endoscopic submucosal dissection (ESD), which are more technically~     difficult to perform, labor intensive, time consuming and carries higher risks of~     complications (bleeding, perforations, etc.). The purpose of this study is to determine the~     effectiveness and safety of the LumenR Retractor in performing EMR and ESD. It is~     hypothesized that the use of this modified colonic overtube will simplify colonoscopic~     removal of difficult polyps, decrease the time needed to complete the procedure and decrease~     the rate of complications post endoscopic removal of large and flat colonic.~   "
115821|NCT02051452|"~     The aim of this study is to investigate whether methylphenidate (Ritalin) can actively induce~     emergence from general anesthesia in patients having a pancreaticoduodenectomy (Whipple~     procedure), a pancreatectomy, or a prostatectomy.~   "
115822|NCT02051439|"~     This study was designed to compare the party balloon assisted Valsalva with the conventional~     Valsava for exhibiting the reverse venous flow in superficial venous valvular incompetence~     duplex examination.~   "
115823|NCT02051426|"~     The efficacy of compounds having agonistic activity at the glycine site associated with the~     N-methyl-D-aspartate receptor (NMDAR) is presently assessed in psychiatric disorders. In~     contrast to NMDAR antagonists, the neuropsychiatric effects of NMDAR agonists in the healthy~     human organism are not known. The investigators studied neuropsychiatric and neurochemical~     effects of the NMDAR-glycine site obligatory co-agonist D-serine (DSR) in healthy subjects~     using a randomized, controlled crossover challenge design including a baseline assessment day~     and two treatment administration days (DSR and placebo in randomized order). Thirty-five~     subjects aged 23-29 years participated in the study and received a 2.1g orally administered~     DSR dose. The main outcome measures were the changes in scores of mood-related Visual~     Analogue Scale (VAS), Continuous Performance Test - Identical Pairs (CPT-IP), and Rey~     Auditory Verbal Learning Test (RAVLT).~   "
115824|NCT02051413|"~     Predictive factors and biomarkers of response to antidepressants in major depressive disorder~     are scarce. Beta-arrestins are proteins which inhibit G Protein Coupled Receptors and~     desensitize serotonergic and dopaminergic receptors. The study hypothesis is that~     Beta-arrestins 1 and 2 are predictive factors and biomarkers of response to antidepressants~     in major depressive disorder. In a controlled prospective open naturalistic monocentric~     3-month study, 60 patients with a major depressive disorder requiring a treatment with~     venlafaxine will be included and assessed before treatment, 1 month and 3 months~     post-treatment. 20 controlled healthy subjects matched for age and gender will also be~     assessed. The Beta-arrestin pathway will be assessed using genetic polymorphisms, Peripheral~     Blood Mononuclear Cell measures and functional pathway. Antidepressant response will be~     assessed using depression scales, olfaction and memory as surrogate markers of neurogenesis.~   "
115825|NCT02051400|"~     The purpose of this study is to evaluate whether the McGrath® MAC video laryngoscope is equal~     or superior when compared to the Glidescope® Ranger and the Macintosh laryngoscope for novice~     users in a simulated airway manikin.~   "
115826|NCT02051387|"~     Despite recent advances in the understanding and treatment of schizophrenia, this devastating~     disease still affects one percent of world's population. Existing antipsychotics reduce~     psychotic symptoms but are generally not very effective in treating so called negative~     symptoms such as blunted affect and social withdrawal or cognitive disturbances due to the~     disease. Furthermore, a significant portion of patients is refractory to all current~     treatments. Therefore new treatment strategies are needed.~      Several studies suggest a strong association between schizophrenia and the endocannabinoid~     system. This system mediates e.g. the pro-psychotic effects of the best-known ingredient of~     the cannabis plant - delta-tetrahydrocannabinol (Δ9-THC). While the pro-psychotic Δ9-THC is~     known to abet the onset of schizophrenia, another, non-psychotomimetic plant ingredient -~     cannabidiol - has recently been shown to exert antipsychotic effects similar to those of one~     of the most effective modern antipsychotics, amisulpride, but it induced significantly less~     side effects.~      In this phase I safety study, the investigators will evaluate the pharmacokinetics,~     pharmacoequivalence, and drug-drug interaction profile with current antipsychotics of a new~     tablet pharmaceutical preparation of cannabidiol in healthy volunteers.~   "
115827|NCT02051374|"~     Lumbar Degenerative Spondylolisthesis (LDS) is a slippage of one vertebra over another caused~     by degeneration of facet joints, ligaments and intervertebral discs. Most patients suffer~     from symptoms related to spinal stenosis, such as radiating pain to the lower extremities,~     and typically increased pain in the lower limbs when walking upright and decreased when~     bending forward.~      There is a moderate grade of evidence for whether patients will achieve better outcome after~     surgery when decompression is followed by fusion. In theory, fusion following decompression~     should give more stability to the operated level, thus less pain and less progression of the~     olisthesis. On the other hand, fusion procedures, in general, are associated with more severe~     complications and postoperative mortality than decompression alone.~      In summary, there is still insufficient evidence for performing fusion in addition to~     decompression for patients with LDS. The investigators are planning a trial where the main~     aim is to detect whether the intervention-related difference in outcome between decompression~     alone (DA) and decompression followed by fusion with instrumentation (DF) is large enough to~     justify the use of the fusion procedure. The proposed trial is a randomized, controlled,~     multicentre, non- inferiority trial with two parallel groups, with 15 participating Norwegian~     hospitals. The main analysis will be performed 2 years after surgery with long-term follow-up~     planned at 5 and 10 years postoperatively.~   "
115917|NCT02050204|"~     Although the prevalence of family-friendly policies in US workplaces has increased~     dramatically, few have been studied using scientifically sound designs. To address this, the~     NIH and CDC formed the Work, Family, and Health Network (WFHN). During Phase 1, the WFHN~     designed and conducted multiple pilot and feasibility studies. For Phase 2, the WFHN~     implemented an innovative intervention based on Phase I pilot studies that is designed to~     increase family-supportive supervisor behaviors and employee control over work, and to~     evaluate the intervention using a group randomized experimental design. Customized~     interventions were performed separately in workplaces of two separate corporate partners.~   "
115828|NCT02051361|"~     Coronary artery stents, particularly drug-eluting stents (DES), are used in the majority of~     patients who undergo percutaneous coronary intervention (PCI) to improve symptoms in patients~     with obstructive coronary artery disease. They function both to prevent abrupt closure of the~     stented artery soon after the procedure as well as to lower the need for repeat~     revascularization compared to balloon angioplasty alone . Stent restenosis and stent~     thrombosis are potential complications of coronary artery stenting; their incidence is~     highest in the first year after PCI. Stent restenosis, which occurs more frequently with bare~     metal stents (BMS) than DES, may occasionally present as an acute myocardial infarction (MI).~     Stent thrombosis is an uncommon but serious complication that often presents as death and is~     almost always accompanied by MI, usually with ST-segment elevation. Patients are commonly~     treated with dual antiplatelet therapy (DAPT) for the recommended duration for the particular~     stent. DAPT (aspirin plus platelet P2Y12 receptor blocker) and significantly lowers the risk~     of stent thrombosis.~   "
115829|NCT02051348|"~     Helicobator pylori (H. pylori) is a bacteria which survives in the lining of the stomach. An~     estimated 50% of the world's population is infected with H. pylori. Developing economies,~     such as in Southeast Asia, the Indian subcontinent and Latin America, have prevalence rates~     of as high as 90%.~      H. pylori infection often goes undiagnosed, as many sufferers do not experience any adverse~     symptoms. Infection with H. pylori is described as not a disease in itself but a condition~     that affects the relative risk of developing various clinical disorders of the upper~     gastrointestinal tract.' Clinically relevant symptoms could include peptic ulcer, melena or~     secondary conditions such as iron deficiency anemia or vitamin B12 deficiency.~      There is evidence that probiotics can be beneficial for those with gastrointestinal diseases.~     Pylopass contains the probiotic strain Lactobacillus reuteri, which was selected for its~     anti-H. pylori characteristics and in clinical trials has shown to result in a reduction in~     urease breath test values in subjects with H. pylori.~      The objective of this study is to evaluate the ability of Pylopass to reduce H. pylori load~     in subjects who are H. pylori positive.~   "
115830|NCT02051335|"~     The purpose of this study is to determine whether scopolamine-induced cognitive impairment is~     attenuated by the administration of roflumilast in combination with donepezil.~   "
115831|NCT02051322|"~     Comparison between three modalities of nebulization.~   "
115832|NCT02051309|"~     Adult daily smokers motivated to quit smoking will be randomized to extended-release~     guanfacine (6mg/day) or placebo and will enroll in an 8-week treatment period combining~     medication with brief behavioral support. The investigators hypothesize that the active dose~     of guanfacine compared to placebo will increase rates of prolonged smoking abstinence at the~     end of the 8-week treatment phase.~   "
115833|NCT02051296|"~     The investigators are looking at whether peri-operative minocycline will reduce the duration~     of pain after minor hand surgery: carpal tunnel release and trigger finger release.~      The investigators' hypothesis is that minocycline will reduce post-operative pain.~   "
115834|NCT02051283|"~     HCC is classified as keratin (K) 19 positive or K19 negative. K19 is a biliary/hepatic~     progenitor cell (HPC) marker only expressed in a subset of HCC with poor prognosis and high~     risk of early recurrence after treatment; particularly in radio-frequency ablation (RFA).~     These patients consequently show worse survival compared to patients with K19 negative HCC.~      A recent publication has shown the value of pretreatment biopsy with K19 staining and~     suggests that the role of routine biopsies in potentially curable HCC should be reconsidered.~      However, currently, pretreatment biopsies are rarely performed in the diagnosis of HCC due to~     the excellent performance of magnetic resonance imaging (MRI) in detection, diagnosis and~     staging of cirrhotic livers.~      Previous publications have indicated imaging patterns that may be associated with worse~     prognostic tumoral parameters.~      If MRI determined imaging parameters could indeed provide a surrogate marker for presence of~     K19 and/or microvascular invasion as potential important prognostic factors in RFA of HCC,~     these imaging parameters may thus hold prognostic information towards RFA treatment and~     possibly predict treatment outcome. .~      The purpose of the retrospective study is thus to evaluate MRI determined imaging parameters~     at pretreatment MRI for their predictive value towards outcome (disease free survival) of~     radio-frequency ablation for hepatocellular carcinoma.~      If successful, pretreatment MRI parameters may be used for selecting patient with high risk~     of unfavorable outcome after RFA and select the patients for more aggressive treatment such~     as surgical resection or upfront transplantation.~   "
115835|NCT02051270|"~     One important issue in older adults with cognitive problems is the higher risk of fall due to~     decreased motor function and balance. The objective of this study is to evaluate the~     repercussions of mild cognitive impairment in balance in elderly.~   "
115836|NCT02051257|"~     This phase I trial studies the highest possible dose of memory enriched T cells that can be~     given following standard stem cell transplant before unmanageable side effects are seen in~     patients with B-cell non-Hodgkin lymphoma that has returned after previous treatment. A T~     cell is a type of immune cell that can recognize and kill abnormal cells of the body. Memory~     enriched T cells will be made from a patient's own T cells that are genetically modified in a~     laboratory. This means that the T cells are changed by inserting additional pieces of~     deoxyribonucleic acid (genetic material) into the cell to make it recognize and kill lymphoma~     cells. Memory enriched T cells may kill the cells that are not killed by stem cell transplant~     and may lower the chances of the cancer recurring.~   "
115837|NCT02051244|"~     The purpose of this study is to determine whether by measuring changes in the thickness of~     the retinal nerve fibre layer (the photosensitive layer at the back of the eye) you could~     predict if someone would develop Alzheimer's disease in the future. The measurement is made~     by OCT (ocular coherence tomography), a noninvasive and relatively inexpensive test that uses~     light waves to scan the back of the eye.~   "
116010|NCT02048995|"~     Objective. Bipolar Disorders (BD) are a major public health problem. The investigators still~     lack knowledge of the mechanisms which contribute to BD. Hence treatments are few and~     limited, and clinical decision making is less refined. Currently, the investigators are~     investigating the effects of midday bright light therapy for the treatment of bipolar~     depression (University of Pittsburgh IRB approved protocol titled Light Therapy for Bipolar~     Disorder, IRB#: PRO09020546). In this study, the investigators propose to investigate a~     possible biological mechanism which might explain response to light treatment in depressed~     bipolar patients.~   "
115838|NCT02051231|"~     Postpartum hemorrhage (PPH) is a leading cause of maternal morbidity and mortality worldwide~     and is caused most commonly by poor uterine muscle tone after delivery. The first line agent~     used in the prevention and treatment of PPH is oxytocin, which acts by binding with oxytocin~     receptors (OTR) found on myometrial cells to cause uterine contraction.~      Women who require augmentation of labour with oxytocin because of inadequate labour~     progression are at increased risk of PPH because they have received intravenous oxytocin~     which exposes the uterus (and OTR) to doses greater than would normally be found without~     medical intervention. This exposure results in OTR desensitization and decreased uterine~     sensitivity to oxytocin which may lead to the use of much higher doses of oxytocin (up to 9x)~     or other agents for preventing and treating PPH with the potential for causing serious~     drug-related morbidity or fatality to the mother.~      Currently, in women who have failed labour augmentation and need to have a Cesarean delivery,~     it is not known if it would be beneficial to wait a certain period of time after~     discontinuing intravenous oxytocin before proceeding with the operation. The goal of the~     waiting time would be to allow the OTRs to recover and resensitize the uterus to the effects~     of oxytocin to avoid the need for high doses or additional uterus-contracting agents.~      Our hypothesis is that there will be a positive correlation between the magnitude of recovery~     of the myometrium's response to oxytocin and the time elapsed from the desensitizing oxytocin~     pretreatment (simulated labour augmentation).~   "
115839|NCT02051218|"~     The aim of the trial is to test the hypothesis that the benefit of denosumab is maintained if~     administered only every 12 weeks as compared to every 4 weeks.~   "
115840|NCT02051205|"~     The purpose of the Parkinson's disease Registry (PDR) is to develop a nation-wide database of~     persons with Parkinson's disease (PD) in Taiwan.~   "
115841|NCT02051192|"~     Behaviorally and cognitive-behaviorally based therapeutic techniques (BT; CBT) that~     incorporate exposure therapy useful for treatment of anxiety disorders among typically~     developing children. Although a large amount of data demonstrate the effectiveness of of BT~     and CBT approaches for treating anxious youth, there is a gap in the literature for the~     effectiveness of these approaches for children under the age of seven. Evidence increasingly~     suggests that family factors such as accommodation and parenting style contribute~     significantly to the presence of anxiety symptoms as well as treatment outcomes, particularly~     in young children. These findings stress the importance of using a treatment approach in~     which parents are directly involved in education, parent training, and generalization of~     treatment effects. Therefore, this study aims to evaluate a new treatment program, parent-led~     behavioral treatment, for children ages 3 to 7 years of age who have a principal anxiety~     disorder diagnosis.~   "
115842|NCT02051179|"~     The aim of this prospective, randomized clinical trial was to assess the effectiveness of~     repair of localized clinical defects of amalgam restorations that were initially scheduled~     for replacement of restorations. A cohort of 20 patients with 40 (Class I and Class II)~     amalgam restorations, that presented one or more clinical features that deviated from the~     ideal (Bravo or Charlie) according to USPHS criteria, were randomly assigned to either, the~     repair or replacement group: A: repair n= 19 and B: replacement n=21. Two examiners who had~     calibration exercised evaluated the restorations at baseline and ten years after according to~     seven parameters: marginal occlusal adaptation, anatomic form, surface roughness, marginal~     staining, contact, secondary caries, and luster~   "
115843|NCT02051166|"~     The purpose of this study is observe clinical practice including glucocorticoids treatment in~     AECOPD in China.~   "
115844|NCT02051153|"~     This project aims to investigate the effect of modafinil on motivation, creativity, cognitive~     performance, and subjective wellbeing in healthy participants. The main task for this~     research project is to address how this novel stimulant acutely influences motivation,~     divergent and convergent thinking, cognitive performance and subjective wellbeing in~     non-sleep deprived healthy young adults.This is a randomised between-subjects parallel group~     design study.~      Based on the hypothesis that psychostimulants might enhance creativity through the increase~     in of dopamine and executive planning in healthy adults , we predict that healthy individuals~     who are in the modafinil condition will perform better in the motivation, creativity, and the~     cognitive performance tasks. Furthermore, based on the evidence that modafinil increases~     dopamine in the nucleus accumbens, putamen and the caudate, we expect specific subjective~     well-being and pleasure enhancement associated with modafinil use in healthy young adults.~   "
115845|NCT02051140|"~     This study is being conducted to assess the effect of dietary strawberry supplementation on~     cognition and mobility in older adults. It is hypothesized that plant compounds, present in~     strawberries, may improve cognition and mobility by protecting against oxidative stress and~     inflammation.~   "
115846|NCT02051127|"~     One of the biggest challenges of today is the high stress levels among employees in companies~     and organizations. Physical exercise may be an effective preventive measure for~     stress-related problems. This relatively simple and inexpensive action is believed to be~     important for increasing and maintaining work ability and reduce the cost of stress-related~     ill health in the workplace.~      The aim is to investigate how regular physical exercise affects the individual's ability to~     mentally and physiologically cope with stress. Acute stress physiological responses are~     measured before and after a 6 -month intervention, where 100 untrained individuals are~     randomized to either regular physical exercise or a control group.~      The hypothesis is that exercise leads to lesser activation of the individual's stress~     physiological systems and to an efficient physiological protection system. Mental ability to~     handle stress is also studied as well as possible effects on the brain's cognitive functions.~     From a work perspective, cognitive impairment due to high exposure to stress is a major~     problem leading to substantial costs in businesses and organizations as a result of reduced~     performance and production.~      We believe that physical activity can alter and mitigate individual stress reactions. This~     study brings new knowledge that can contribute to increased motivation to prioritize physical~     activity in everyday life. The study could also provide evidence for businesses and~     organizations of the benefits of engaging in interventions and fitness initiatives to~     facilitate/enable increased physical activity in daily life for its employees. With an aging~     population, we are expected to work longer, which poses a challenge as the ability to manage~     stress and maintain cognitive abilities decline with age. For older employees, regular~     physical activity could be an important factor directly affecting the prospects for a~     sustainable working life.~   "
115847|NCT02051114|"~     Longitudinal study of patients with rheumatoid arthritis comparing measures of disease~     activity with blood samples.~   "
115848|NCT02051101|"~     The purpose of this study is to investigate the pathogenic mechanisms of Port Wine Stain,~     collect biopsy samples and blood samples to characterize exosomes and metabolites from Port~     Wine Stain.~   "
116011|NCT02048982|"~     The purpose of this study is to test whether physicians change their use of non-recommended~     tests, procedures, or medications more in response to evidence based-guidelines, price~     information, or an individual patient's story.~   "
115849|NCT02051088|"~     Peripheral arterial disease (PAD) causes reduced blood flow to the lower limb(s) due to~     stenosis or occlusion in the supplying arteries. Symptoms of PAD range from ischemic rest~     pain and/or ischemic ulcers/gangrene (critical limb ischemia), putting the extremity at risk~     of amputation, to exercise-induced pain (intermittent claudication), limiting the patients~     daily activities. Invasive treatments are often indicated to prevent amputations and to~     alleviate symptoms. More than two thirds of these procedures are presently performed with~     endovascular techniques (i.e. percutaneous transluminal angioplasty, PTA with or without~     stent implantation).~      In coronary artery disease, stents eluting anti-proliferative drugs (drug eluting stents,~     DES) reduce restenosis and improve clinical results for the majority of patients. Drug~     eluting balloons (DEB) are a promising alternative, but there is still little evidence that~     DES or DEB technology improve clinical outcome in PAD. However, promising results utilizing~     these new technologies in PAD have been reported in a few studies.~      In this trial, we test the hypothesis that drug eluting (DE) technology is superior to~     conventional endovascular treatment (no-DE) in terms of important clinical outcomes, when~     applied on infrainguinal (femoropopliteal and/or infrapopliteal) obstructive vascular~     lesions. The trial consists of 2 separate parallel studies, SWEDEPAD 1 and SWEDEPAD 2, each~     defined by the severity of peripheral arterial disease. Patients with critical limb ischemia~     are allocated to SWEDEPAD 1 and patients with intermittent claudication are allocated to~     SWEDEPAD 2.~   "
115850|NCT02051075|"~     Immotile sperm is a rather frequent problem encountered in IVF patients. Treatment is usually~     based on inducing motility with pentoxyphylline (PXN) followed by ICSI. However,~     fertilization rate with this method is still lower compared with ICSI using motile sperm. One~     of the reasons for that is the immotile sperm inability to activate the oocyte Our research~     hypothesis is that better fertilization rate can be accomplished in these cases by combining~     PXN sperm activation with Ca ionophore oocyte activation.~   "
115851|NCT02051062|"~     The purpose of this study is to verify the pediatric dosing recommendations for BAT® in~     pediatric patients that are treated with BAT® due to a confirmed or suspected case of~     botulism. One 5 mL blood sample will be obtained within 24 hours post BAT® administration.~     Study BT-011 will be run concurrently with the BAT patient registry (BT-010).~   "
115852|NCT02051049|"~     The purpose of this study is to assess the long-term safety follow-up of patients having been~     treated with HepaStem.~   "
115853|NCT02051036|"~     This study aims to explore the feasibility of moxibustion as a supplementary intervention and~     to assess the sample size for verifying the effectiveness and safety of integrative treatment~     involving moxibustion compared with conventional treatment for patients with benign prostate~     hyperplasia (BPH) accompanying moderate to severe lower urinary tract symptoms (LUTS).~   "
115854|NCT02051023|"~     Hypothesis: Fluorometholone (FML) 0.1% eyedrops topically applied 4 times a day for 22 days~     is more efficient than artificial tears (Liquifilm) in dry eye disease (DED) and ameliorates~     the worsening of the disease after exposure to an adverse controlled environment.~   "
115855|NCT02051010|"~     The study will follow a descriptive design involving a survey. Data collection will involve~     paper based questionnaires. The questionnaires have been developed in conjunction with breast~     cancer support groups associated with the Irish Cancer Society and patients.~   "
115856|NCT02050997|"~     This is an exploratory, translational, non-interventional and multi-centre clinical study.~     The aim of the study is to identify predictive plasma biomarkers of response to chemotherapy~     in PDAC.~   "
115857|NCT02050984|"~     Bariatric surgery is generally recommended for obese people with a body mass index (BMI) of~     at least 40kg/m2, and for people with BMI 35 kg/m2 and serious coexisting medical conditions~     such as diabetes. A variety of studies showed that it cause significant weight loss, recovery~     from diabetes and improvement in cardiovascular risk factors, such as blood pressure. The~     recent guidelines suggest that patients with a BMI of more than 30 kg/m2 with co morbidities~     is a candidate for bariatric surgery. However, the patients with diabetes in Chinese has~     lower BMI than that in west country. Therefore, this research is designed to observe whether~     bariatric surgery reduce blood pressure in patients with diabetes and relatively lower BMI.~   "
115858|NCT02050971|"~     The purpose of this study is to test the safety and effectiveness of a whole own (autologous)~     umbilical cord blood transfusion in the first 5 days after birth if the baby is born~     premature <34 weeks and developed anemia of prematurity.~   "
115859|NCT02050958|"~     Oxford Pharmascience (the sponsor) is developing a new formulation of Ibuprofen (OXP001 - the~     study drug) which it is proposed will have less of the side effects than are currently~     reported with standard prescription strength Ibuprofen.~      This study will compare the study drug to an already marketed formulation of prescription~     strength Ibuprofen (the reference product) by looking at how the drug is taken up by the body~     and also by performing a specialist procedure called an endoscopy (or more specifically a~     gastroscopy). The safety and tolerability of the study drug will also be assessed.~      The study will involve approximately 44 healthy male and female subjects. Subjects will be~     randomly assigned to receive either the study drug or reference product for 8 days. On Day 1,~     subjects will receive a single 800 mg dose of ibuprofen. On Days 2 to 9, subjects will~     receive 800 mg ibuprofen three times a day.~   "
115860|NCT02050945|"~     The purpose of the present project is to investigate the physiological effects of two~     different types of exercise training in COPD patients. The patients will be examined before,~     during and after 8 weeks of training to evaluate the effect of different types of skeletal~     muscle stimulation on health related quality of life, 6 min walking distance, flow mediated~     dilation, and histological properties of skeletal muscle cells, regarding oxidative capacity,~     fiber type, purinergic receptor amounts and measures of systemic inflammation. The study will~     test the hypothesis that:~      Resistance training is superior to endurance training in patients with COPD~   "
116012|NCT02048969|"~     The purpose of this study is to test feasibility of measuring flumazenil-induced changes in~     cortical GABA levels observed with localized 1H-MRS in relation to changes in severity of~     hepatic encephalopathy (HE) in subjects with non-alcoholic liver cirrhosis. This study is a~     double-blind, placebo-controlled, randomized, cross-over design.~   "
118560|NCT02015702|"~     This study was intended to test the effects of adding a one-on-one educational intervention~     taught by a physician to a physician during their clinical work to improve their acceptance~     and satisfaction with a new inpatient electronic health record and ordering system.~   "
115861|NCT02050932|"~     Background: Oral iron supplementation (OIS) is a widely-used strategy to treat iron~     deficiency anemia. However, absorption of OIS is often low and response is variable. To~     overcome this, large doses are given but this may reduce compliance due to gastric~     irritation. Thus, OIS doses should be low, while maximizing absorption. The prevailing serum~     hepcidin concentration (SHep) is the major determinant of iron absorption and erythrocyte~     iron utilization. Based on limited data in humans, SHep can be increased by a single OIS dose~     but the duration of the increase is uncertain: In a recent study conducted in our laboratory~     it has been found to last approx. 24 h. Also, there are few data on how the increase in SHep~     determines the absorption of further doses of oral iron. Is there a threshold SHep at which~     subsequent iron absorption is sharply reduced? Better understanding of this relationship~     would be valuable to design more effective and safer OIS regimens.~      Objectives: 1) Determine whether two consecutive dosages of 60 mg Fe differently affect~     hepcidin response and iron bioavailability (Study 1) 2) Compare the bioavailability of iron~     supplement dosages given at different times of the day (Study 2).~      Methods/Subjects: Healthy female subjects will be screened for low iron status. Anemic~     subjects will be excluded from the study. Thirty two subjects will be included with serum~     ferritin <20 µg/L, C-reactive protein <5 mg/L and Hemoglobin >117 g/L. Subjects will be~     randomized in two groups and their Hepcidin (sHep) and iron status markers monitored at day 1~     (baseline). Subjects will receive iron supplement dosages of 60 mg with stable iron isotopes~     54Fe, 57Fe, 58Fe in form of 4 mg of FeSO4. Prior administration blood samples will be~     collected to monitor sHep and iron status markers.~      Outcome: The combined use of stable iron isotopes and a sensitive SHep assay will allow for~     better understanding of the iron-hepcidin relationship and this may enable design of more~     effective OIS regimens.~   "
115862|NCT02050919|"~     This phase II trial studies how well sorafenib tosylate, combination chemotherapy, radiation~     therapy, and surgery work in treating patients with high-risk stage IIB-IV soft tissue~     sarcoma. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Drugs used in chemotherapy, such as epirubicin hydrochloride~     and ifosfamide, work in different ways to stop the growth of tumor cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. Radiation~     therapy uses high energy x rays to kill tumor cells. Giving sorafenib tosylate, combination~     chemotherapy, radiation therapy, and surgery may be an effective treatment for soft tissue~     sarcoma.~   "
115863|NCT02050906|"~     This randomized pilot clinical trial studies intensive diet and exercise or standard of care~     in improving physical function and quality of life in patients with prostate cancer~     undergoing androgen deprivation therapy. Diet and exercise may help improve physical function~     and quality of life in prostate cancer patients. It is not yet known whether intensive diet~     and exercise is more effective than standard of care in improving physical function and~     quality of life in patients with prostate cancer undergoing androgen deprivation therapy.~   "
115864|NCT02050893|"~     Fluid resuscitation remains the foundation for septic treatment.The evaluation of fluid~     responsiveness has significance in volume resuscitation for septic shock patients. As the~     sedative which is commonly used in ICU, Midazolam is supposed to change fluid responsiveness~     for the pharmacological effect of venodilation. However, the hypothesis has not been~     certified clinically. In this research, the investigators aim to test the hypothesis that~     Midazolam can increase fluid responsiveness(using passive leg raising test) in septic shock~     patients.~   "
115865|NCT02050880|"~     The purpose of this study is to asses the agreement of the RS-3000 Lite and RS-3000 Advance~     to the RS-3000, assess the crossed precision of each study device and to assess the~     transference of a reference database from the RS-3000 to the RS-3000 Lite and to the RS-3000~     Advance.~   "
115866|NCT02050867|"~     Physicians and nurses working in non-mental health settings require tools to guide them in~     recognizing patients at risk. While screening children and adolescents is emerging as a~     priority of the Joint Commission, there are currently no suicide screening instruments~     designed specifically for assessing suicide risk in a pediatric inpatient medical population.~     Recently, our study team developed the Ask Suicide-Screening Questions (ASQ), a 4-item~     suicide risk screening instrument with excellent sensitivity, specificity, and negative~     predictive value for use in pediatric emergency departments (Protocol #08-M-N070). However,~     use of the ASQ in an inpatient medical setting has not been tested. The aim of this study is~     to determine the utility of the ASQ among pediatric medical inpatients in children s~     hospitals. While most inpatients will not be at imminent risk for suicide, we hypothesize~     that the ASQ will capture a number of patients who screen positive and are not only at risk~     for suicidal behavior in the future, but are also experiencing significant emotional distress~     and therefore warrant further psychiatric evaluation and follow-up treatment. This will be a~     multisite study, comprised of medically ill inpatients at three non-NIH affiliated sites~     (Children s National Medical Center, Boston Children s Hospital, and Nationwide Children s~     Hospital), with a total sample size of 600 (200 per site). We will administer several short~     measures of suicide risk the ASQ, the Suicidal Ideation Questionnaire, a brief depression~     screen, the Patients Health Questionnaire Adolescent version (PHQ-A) to all eligible~     inpatients aged 10-21 years. The ultimate goal of this project is to provide non-mental~     health clinicians with a brief, accurate assessment tool for detecting risk of suicide in~     pediatric medical inpatients and in turn, connecting those in need with mental health~     services. After validating the ASQ with pediatric medical inpatients, we will then examine~     the practical implications of nurses administering the ASQ as standard of care during the~     admission process on a pediatric medical inpatient unit. Future studies will focus on~     validating the ASQ in non-English speaking patients, addressing a critical gap in suicide~     prevention research. In addition, examining the long-term clinical impact of screening~     general medical patients for suicide risk with the ASQ and linking those in need with mental~     health services and/or other interventions will be important next steps.~      Please note: This is a multi-site study that is being conducted at three non-NIH sites, all~     children s hospitals, two of which have already received IRB approval (Boston Children s~     Hospital and Children s National Medical Center) and one which is in the process of~     submission (Nationwide Children s Hospital). No NIH patients will be enrolled at the Clinical~     Center. Consent and patient data collection will take place on inpatient medical units at~     those three sites; data will be sent to NIMH, and stored and analyzed here.~   "
115867|NCT02050854|"~     The purpose of this study is to evaluate the pharmacokinetics of aripiprazole in subjects~     with Bipolar 1 Disorder or Schizophrenia who have a history of suboptimal aderence and are~     currently on treatment with oral aripiprazole.~   "
115868|NCT02050841|"~     The purpose of this study is to investigate the safety, tolerability and efficacy of octaplas~     in pediatric patients who require replacement of multiple coagulation factors. Replacement of~     multiple coagulation factors in pediatric patients with acquired deficiencies due to liver~     disease and in pediatric patients requiring cardiac surgery or liver surgery.~   "
115869|NCT02050828|"~     The purpose of this study is to evaluate the safety and efficacy of AKB-9778 administered as~     daily subcutaneous injections with and without monthly intravitreal injections of ranibizumab~     for 3 months in patients with diabetic macular edema.~   "
115870|NCT02050815|"~     This study is a phase I, multi-center, open-label, single oral dose, parallel group study to~     assess the PK and safety of MEK162 in subjects with impaired hepatic function and healthy~     subjects with normal hepatic function. Subjects will be assigned by hepatic function defined~     by elevation of serum total bilirubin and serum AST as determined at the screening and~     baseline visits. The study population will be healthy male and postmenopausal or sterile~     female subjects who meet all of the inclusion and none of the exclusion criteria. A minimum~     of 24 evaluable subjects (6 subjects per group) will be enrolled. The groups are: Group~     1-healthy volunteers, Group 2-Mild hepatic impairment, Group 3-Moderate hepatic impairment~     and Group 4-Severe hepatic impairment. Once approved for enrollment, participants will be~     confined to the facility for 5 days, given a single dose of MEK162 and monitored for safety~     assessments, labs and PK will be assessed.~   "
115874|NCT02050763|"~     Intimate partner violence (IPV) is a precursor to and consequence of HIV infection. Few~     interventions combining HIV and IPV prevention have been evaluated and none has significantly~     decreased both outcomes.~      A cluster-randomized trial was conducted in Rakai, Uganda. Four intervention arm clusters~     (N=5,339) received an IPV prevention intervention (the Safe Homes and Respect for Everyone~     (SHARE) Project), enhanced HIV testing and treatment and routine HIV services provided by~     Rakai Health Sciences Program (RHSP). Seven control arm clusters (N=6,112) received standard~     of care HIV services alone.~      Baseline and two follow-up visits were conducted via the Rakai Community Cohort Study between~     2005 and 2009. Primary outcomes were past year emotional, physical and sexual IPV and HIV~     incidence. Secondary outcomes included past year intimate partner rape/forced sex, number of~     total and extra-marital sex partners, alcohol use surrounding sex, condom use, discussion~     about condom use, partner's disclosure of HIV status and respondent's disclosure of HIV~     status. Analysis was by intention-to-treat. Modified Poisson regression was used to estimate~     prevalence risk ratios (PRR) to detect the impact of the intervention on IPV and secondary~     outcomes. Poisson regression was used to estimate incidence rate ratios (IRR) of HIV~     acquisition per 100 person years (py).~      Our study had three research aims and related hypotheses.~      Aim 1 was to assess the impact of SHARE + RHSP community services on report of victimization~     from and perpetration of physical and/or sexual IPV in the past 12 months, compared to the~     impact of RHSP community services alone.~      Hypothesis 1(a): SHARE intervention will reduce women's reports of IPV victimization in~     intervention vs. control arms.~      Hypothesis 1(b): SHARE intervention will reduce men's reports of IPV perpetration in~     intervention vs. control arms.~      Aim 2 was to assess the impact of SHARE + RHSP services on report of sexual risk behaviors~     among men and women compared to the impact of RHSP community services alone.~      Hypothesis 2(a): SHARE intervention will reduce selected sexual risk behaviors in the~     intervention vs. control arms.~      Aim 3 was to assess the impact of SHARE + RHSP services on HIV incidence compared to the~     impact of RHSP community services alone.~      Hypothesis 3(a): Incidence of HIV will be lower in the intervention vs. control arms.~   "
115875|NCT02050750|"~     This is an exploratory, translational, non-interventional and multi-centre biobank. The aim~     of the development of such a biobank is to identify potential biomarkers that are indicative~     of disease relapse.~   "
115876|NCT02050737|"~     This is an exploratory, translational, non-interventional and multi-centre clinical study.~   "
115877|NCT02050724|"~     Title ThoHSpEkt~      Study Design Pilot Study concerning the technical operative methods and a phase II study~     concerning the radiopharmaceutical (therapeutic-explorative study with an approved drug in a~     new indication)~      Location Kantonsspital St.Gallen~      Aim Proof of feasibility of thoracoscopic ectomy of radioactively marked pulmonary nodules~     with the help of free-hand SPECT.~      Background In the Cantonal Hospital of St.Gallen an average of 30 - 40 patients will be~     operated with thoracoscopic ectomy for a pulmonary nodule. When localisation of the nodule is~     not possible a switch to minithoracotomy is performed.~      Study intervention Marking of pulmonary nodules with radioactivity. Free-hand SPECT guided~     surgery~      Risks Risks of bronchoscopic or CT-intervention Radiation risk (minimal)~      Rational for patient number 10 patients for each group are enough to prove the feasibility,~     to manage difficulties and to record complications~      Duration approximately 24 months.~   "
115878|NCT02050711|"~     The effect of pulmonary rehabilitation in patients with chronic obstructive pulmonary disease~     (COPD) has been based on systemic outcome measures, however, little is known about the~     effectiveness of this intervention on patients' lung function. The forced expiratory volume~     in one second (FEV1), despite of being the gold standard for assessing lung function in COPD,~     is poorly responsive to pulmonary rehabilitation. Thus, an objective and responsive outcome~     measure to assess the effect of pulmonary rehabilitation on lung function is needed.~      Computerized respiratory sounds have been found to be a more sensitive indicator, detecting~     and characterizing the severity of respiratory diseases before any other measure, however its~     potential to detect changes after pulmonary rehabilitation has never been explored.~     Therefore, this study aims to assess the effects of pulmonary rehabilitation on the~     characteristics of computerized respiratory sounds in patients with COPD.~      A randomized controlled study with one group undergoing pulmonary rehabilitation (n=25) and~     other group receiving standard care (n=25) will be conducted. The pulmonary rehabilitation~     program will included exercise training (3*week) and psychoeducation (1*week).~      Computerized respiratory sounds, lung function, exercise capacity, quadriceps muscle~     strength, health-related quality of life and health services use will be assessed in both~     groups, at baseline, immediately post-intervention and at follow-ups (3 and 6 months after~     PR).~      Descriptive and inferential statistics will be used.~      It is expected that significant changes occur on the characteristics of computerized~     respiratory sounds in patients enrolled in the pulmonary rehabilitation group, in comparison~     with patients receiving standard care. Thus, computerized respiratory sounds could provide a~     simple, objective and non-invasive measure to assess lung function changes after pulmonary~     rehabilitation.~   "
115879|NCT02050698|"~     Fifth metatarsal avulsion fractures are common and can usually be treated conservatively.~     Symptomatic care consisting of protected weightbearing in a hard-soled shoe, air-cast walking~     boot, or below-knee walking cast have been successful. Several papers reported that early~     rehabilitation may decrease ankle stiffness, muscle and bone atrophy, and aids in early~     return to activities. However, early motion of the ankle joint may have the risk of~     displacement of the fifth metatarsal avulsion fractures. However, studies using hard-sole~     shoe for protected weightbearing and allowing motion of the ankle joint had successful~     results. Clapper et al. compared the results of hard-soled shoe and walking cast for a fifth~     metatarsal avulsion fracture and reported that all avulsion fractures healed uneventfully and~     that the results were similar between the two. However, this was not a randomized controlled~     trial.~      Devices such as air-cast walking boot, plaster slipper, or Jone's dressing can also be used~     for the treatment. However, we decided to compare results of hard-soled shoe and short leg~     walking cast for the treatment of a fifth metatarsal avulsion fracture.~      We hypothesized that the 100mm visual analogue scale (VAS) assessed on 6 months after a fifth~     metatarsal avulsion fracture treated with protected weightbearing in a hard-soled shoe is not~     inferior to protected weightbearing in a short leg walking cast but is superior to short leg~     walking cast with respect to time to return to normal daily life and patient's satisfaction.~   "
115880|NCT02050685|"~     Comparison of different screening score for hypoxemic OSA (Obstructive Sleep Apnea) with the~     results of a polysomnography (PSG). The different screening score studied are: STOP-BANG,~     DES-OSA, P-SAP and OSA50.~   "
115881|NCT02050672|"~     In the present trial, the investigators aim to evaluate whether semen myo-inositol (MI)~     treatment is able to improve IVF outcomes.~      In particular, retrieved oocytes will be randomly divided in two groups, one group will be~     inseminated with MI treated semen while the other will be inseminated with untreated semen.~   "
115882|NCT02050659|"~     In patients with gastric cancer, traditionally a complete omentectomy is performed as part of~     a radical gastrectomy with a modified D2 lymph node dissection. The omentectomy increases~     operation time significantly, especially in laparoscopic procedures. Patients remain more~     vulnerable for peritoneal infections and intestinal adhesions following omentectomy.~     Furthermore one can debate whether a complete omentectomy is indicated from an oncologic~     viewpoint. In the present study we prospectively evaluated the presence of tumor load in the~     greater omentum of patients with potentially curative gastric cancer.~   "
115883|NCT02050646|"~     The purpose of this study is to determine whether a salt restriction diet improves immune~     parameters in patients with autoimmune hepatitis.~   "
115884|NCT02050633|"~     The objective of the protocol is to pursue the long-term follow-up of a large cohort of~     severe traumatic brain injury patients. This outcome is to be described in terms of activity,~     participation, quality of life, socio-professional outcome, economical consequences and~     impact on caregivers, and in relation to health care provision.~      Secondary objectives are to measure the impact on outcome of several predictive factors; to~     evaluate evolution of patients since the last (four-year) evaluation.~   "
115886|NCT02050607|"~     Obesity is associated with changes in the composition and metabolic function of the gut~     microbiota. Fecal microbiota transplantation (FMT), also known as fecal bacteriotherapy or~     fecal infusion, refers to the process of injecting a liquid suspension of stool from a~     healthy donor into the gastrointestinal (GI) tract of a patient to cure a specific disease.~     However, since the recently established concept of human gut microbiome and its significant~     role in health and disease has caught on in the medical scientific world, this procedure has~     gained a great pathophysiological strength, meaning not only the simple infusion of stools,~     but the transplantation of a healthy gut microbiota in a patient with a disrupted one. In a~     recent dutch experience, FMT from lean donors was able to increase the insulin sensitivity in~     patients with metabolic syndrome.~      Our primary aim is to evaluate if FMT from lean healthy donors, in association to lifestyle~     changes, is able to reduce insulin-resistance more than lifestyle changes alone in patients~     with metabolic syndrome.~      All the patients with metabolic syndrome will receive lifestyle counselling (1400~     kilocalories diet and physical activity encouragement), than will be randomized to FMT from~     healthy lean donors by upper endoscopy (group A) or no treatment (group B)~   "
115887|NCT02050594|"~     The primary objective of the protocol is to identify and describe observed adverse events~     (AEs) while on treatment with Ipilimumab for advanced melanoma in Venezuela during the study~     period~   "
115888|NCT02050581|"~     In this prospective and retrospective chart review, investigators will evaluate the response~     rates and duration of response for patients with relapsed and refractory idiopathic~     thrombocytopenic purpura (ITP) who have been treated with rituximab and repeated courses of~     dexamethasone. Investigators will also evaluate observed toxicities of the combination, and~     characteristics associated with response.~   "
115889|NCT02050568|"~     Since year 2003, Glostrup/Herlev Hospital has devised a novel technique, urethral pressure~     reflectometry (UPR), for measurements of pressure and cross-sectional area in the female~     urethra. UPR has been able to separate continent women from women with stress urinary~     incontinence (SUI, defined by involuntary leakage during increased abdominal pressure). The~     method stands alone in its field.~      9.5 % of all women undergo genital prolapse surgery during their lives (genital prolapse is~     characterized by a portion of the vaginal canal protruding from the opening of the vagina).~     However, 10-30 % of these women develop SUI after surgery, while approximately 40 % with~     preoperative SUI actually experience an improvement in their condition. Efforts have been~     made to predict the likelihood of a patient having SUI after genital prolapse surgery;~     however the tests have shown disappointing positive and negative predictive values.~      A mid-urethral sling is gold standard for treatment of SUI and to avoid SUI after genital~     prolapse surgery, some clinics choose to treat all their patients with a sling,~     simultaneously. However, not all patients with SUI require surgery and the sling is~     associated with some risks, such as bleeding and bladder injury. There is no international~     consensus on the use of mid-urethral slings in women undergoing genital prolapse surgery.~     Thus, there is great need for knowledge and know-how regarding the mechanism of continence in~     women with genital prolapse, before and after surgery.~      The hypothesis is that UPR may be used to uncover the changes in the female urethra before~     and after genital prolapse surgery, revealing significant differences in the parameters in~     women who develop SUI after surgery. UPR may become an important tool in the preoperative~     assessment, helping clinicians give better information and guidance to their patients.~   "
115890|NCT02050555|"~     This study is designed to evaluate the effect of koji-extracted beverage fermented with~     Pediococcus pentosaceus LP28 on BMI and body fat in overweight subjects.~   "
115891|NCT02050542|"~     The purpose of the study is to show that 3 targeted biopsies on the suspicious image detected~     by IRM, guided by a fusion of MRI and ultrasound- images with the Koelis ® system, will get~     no lower rate of cancer detection than those obtained by 12 systematic transrectal~     ultrasound-guided biopsies of the prostate.~   "
115892|NCT02050529|"~     Severe Hypertension in pregnancy demands urgent treatment because of high mortality &~     morbidity in obstetric patients. Hydralazine, the most commonly used agent, causes sudden~     hypotension and tachycardia. Labetalol because of combined α and β blocking effects lacks~     these side effects. Cochrane systematic review could include only three trials of comparison~     of hydralazine with labetalol. All three had sample size ranging from 20-60 obstetric,~     including 19-30 pregnant women. This review could not conclude about comparative effects due~     to insufficient data and suggested that further trials should compare hydralazine with~     nifedipine or labetalol, and to report severe persistent hypertension and adverse~     feto-maternal effects.~      OBJECTIVES:1) To compare efficacy of labetalol versus hydralazine for control of pregnancy~     related severe hypertension.2) To compare adverse maternal and fetal effects of the two~     drugs.~      3) Furthermore, to develop risk assessment model for response to treatment, in terms of~     patient and disease characteristics.~      STUDY DESIGN: Randomized controlled trial.~      SETTING & DURATION OF STUDY: Gynaecology Unit I, Civil hospital Karachi over a period of 1~     year.~      METHODS: Total one hundred eighty patients with, severe hypertension(systolic blood~     pressure(SBP)≥160 and/or diastolic blood pressure(DBP) ≥110 mm Hg) at greater than 28 weeks~     of pregnancy or upto72 hours after delivery, will be enrolled. In each group 90 patients will~     be allocated to intravenous labetalol or hydralazine using simple random sampling. Primary~     outcome measures will be lowering of SBP to <160 mm Hg and DBP <110 mm Hg and severe~     persistent hypertension. In addition maternal hypotension, tachycardia, bradycardia, adverse~     effect on fetal heart, still birth and neonatal bradycardia will be measured.~      EXPECTED OUTCOME: Efficacy and side effects of labetalol against hydralazine, in our~     population will be determined. Assessment model for response to treatment, will help in~     choosing a drug with better efficacy and minimal side effect profile for different patient~     and disease profiles.~   "
115893|NCT02050516|"~     Does group culture using micro-well group culture dishes improve human blastocyst development~     compared to single embryo culture?~   "
115894|NCT02050503|"~     An open-label, non-randomized study to assess the titration, safety and efficacy of~     intranasal fentanyl pectin nasal spray for the treatment of secondary breakthrough pain~     secondary to radiation-induced mucositis in patients with confirmed tolerance of opioid~     therapy for chronic pain.~      Study objectives include assessment of breakthrough pain episodes related with food intake in~     patients with mucositis secondary to radiotherapy or radio-chemotherapy for head and neck~     tumors~   "
115895|NCT02050490|"~     This study investigates whether the implementation of a symptom diary for reporting and~     communicating chemotherapy-related symptoms improves symptom care and decreases symptom~     burden in adult patients treated with chemotherapy.~      The hypothesis is studied using a before-and-after design. First, symptom care and symptom~     burden will be observed in a sample of patients not being offered a symptom diary. Next, the~     symptom diary will be implemented at the participating hospital and symptom care and symptom~     burden will now be observed in a new sample of chemotherapy patients.~   "
115896|NCT02050477|"~     Evaluation of the laparoscopic approach of the Magenstrasse and Mill procedure in a~     prospective study of 100 patients~   "
116013|NCT02048956|"~     Knee osteoarthritis is a common condition characterized by pain and functional disability in~     older people. Prevalence increases with age and is more frequent in older women. The aim of~     this study was to assess the effects of an 8-weeks hydrotherapy training with elastic bands~     on pain and functional disability in old people with knee osteoarthritis.~   "
126723|NCT01908764|"~     The purpose of this study is to describe the pharmacokinetics of AL-60371 otic suspension~     following two posologies of bilateral ototopical doses in pediatric subjects immediately~     after bilateral tympanostomy tube surgery.~   "
115897|NCT02050464|"~     The Virtual Physiological Human: DementiA Research Enabled by IT (VPH-DARE@IT) is a four-year~     IT-project funded through the European Union (EU). The project consortium involves a total of~     21 universities and industrial partners from 10 European countries. The project delivers the~     first patient-specific predictive models for early differential diagnosis of dementia and~     their evolution. An integrated clinical decision support platform will be validated / tested~     by access to a dozen databases of international cross-sectional and longitudinal studies. As~     a part of the VPH-DARE@IT project, a new prospective cohort will be collected in Kuopio. This~     prospective cohort will be used to test further the modeling approaches and tools developed~     by using the retrospective databases.~   "
115898|NCT02050451|"~     The current study is designed to assess the impact of an enriched oral nutritional shake~     (Ensure Plus®) to improve the nutritional status and patient outcome after surgery to remove~     a cancerous bladder (radical cystectomy). Radical cystectomy with urinary diversion using a~     segment of intestine is the standard of care for invasive bladder cancer. This operation has~     a high complication rate and several studies have shown that this may be directly related to~     poor nutrition.~      The investigators believe that patients who consume an enriched nutritional shake before and~     after surgery will improve their nutrition status and experience fewer complications, shorter~     length of stay and less readmissions compared to those who do not.~      Patients who are scheduled to undergo elective radical cystectomy will be eligible for~     enrollment. Once enrolled, they will be randomly assigned to one of two groups. One group~     will be offered Ensure Plus® twice daily for 2 weeks before and 4 weeks after their surgery~     and the other will be offered a daily over-the-counter multivitamin for the same period of~     time. The investigators will follow both groups for up to 30 days after their surgery and~     compare clinical outcomes such as: complication rates, length of stay, readmission rates and~     mortality as well as measure serum markers of nutrition status and assess changes in body~     composition.~   "
115899|NCT02050438|"~     The purpose of this study is to determine whether different kind of prostesis designs~     influences in the quality of life of patients~   "
115900|NCT02050425|"~     Clinical trial in patients with obstructive sleep apnoea that are randomised to either~     continue or withdraw continuous positive airway pressure therapy to identify a~     disease-specific exhaled breath pattern by mass spectrometry.~   "
115901|NCT02050412|"~     Measurement of skin reactivity of cat dander samples obtained by different methods.~      Subjects will be assessed for the study by of a conventional skin prick test with a positive~     (histamine), a positive (standardized cat dander extract) and a negative allergen control (a~     diluent) if they fulfil all other in- and exclusion criteria, too.~      A screening prick test will be performed in order to confirm positivity (cat dander allergy).~      A scratch test will be performed in participants after a positive screening prick test, in~     order to measure skin reactivity to cat dander, originating of three different body areas of~     the cat. For this purpose, a small amount of cat fur in solution with distilled water will be~     placed onto the volar aspect of both forearms after the skin has been scratched with a~     scratch lancet. The distilled water in which the cat hair was solved before will serve as~     negative control.~      This procedure will be repeated with fur of the three different areas of the cat, always~     using triplicates (nine samples per cat).~      From each of the 20 cats, nine samples will be tested on 20 subjects (one cat/subject).~   "
115902|NCT02050399|"~     Coronary artery disease (CAD) and diabetes mellitus (DM) may promote alterations in heart~     responses during exercise or postural maneuver. Thus, the purpose of this study is to observe~     the influence of different postures (supine, seated and standing) and different percentages~     (15, 30, 45 and 60%) of the maximum voluntary contraction (MVC) of handgrip in the responses~     of heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean~     arterial pressure (MAP), cardiac output (CO), stroke volume (SV) and peripheral vascular~     resistance (PVR) in coronary patients with and without type 2 diabetes.~   "
115903|NCT02050386|"~     This is a study designed to look at how arousal levels in the brain change with age and how~     these changes influence thinking, vision, hearing and physical function in people of advanced~     age.~   "
115904|NCT02050373|"~     The aim of the study was to evaluate the effect of low-level laser therapy (LLLT) on the~     severity of oral mucositis (OM) and inflammatory mediators (pro- and anti-inflammatory~     cytokines, metalloproteinases and growth factors) levels in saliva and blood of hematopoietic~     stem cell transplantation (HSCT) patients.~   "
115905|NCT02050360|"~     The purpose of this study is to determine whether on-demand sildenafil is effective in the~     treatment of Raynaud's phenomenon.~   "
115906|NCT02050347|"~     Patients have a type of lymph gland cancer called Non-Hodgkin Lymphoma (NHL), acute~     lymphocytic leukemia (ALL) or chronic lymphocytic leukemia (CLL) (these diseases will be~     referred to as lymphoma or leukemia). The lymphoma or leukemia has come back or has not~     gone away after treatment (including the best treatment known for these cancers). Because~     there is no standard treatment for this cancer at this time, subjects are asked to volunteer~     to be in a gene transfer research study using special immune cells.~      The body has different ways of fighting infection and disease. No one way seems perfect for~     fighting cancers. This research study combines two different ways of fighting disease,~     antibodies and T cells, hoping that they will work together. Both antibodies and T cells have~     been used to treat patients with cancers; they have shown promise, but have not been strong~     enough to cure most patients.~      T cells can kill tumor cells but there normally are not enough of them to kill all the tumor~     cells. Some researchers have taken T cells from a person's blood, grown more of them in the~     laboratory and then given them back to the person.~      The antibody used in this study is called anti-CD19. This antibody sticks to cancer cells~     because of a substance on the outside of these cells called CD19. CD19 antibodies have been~     used to treat people with lymphoma and leukemia. For this study, the CD19 antibody has been~     changed so that instead of floating free in the blood it is now joined to the T cells. When~     an antibody is joined to a T cell in this way it is called a chimeric receptor. The T~     lymphocytes will also contain CD28, which stimulates T cells and makes them last longer.~      Treatment with CD19/CD28 chimeric receptor-T cells has had activity against lymphoma and~     leukemia when the cells are made from the patients affected by these diseases. In this study,~     investigators are going to see if this treatment works even better when they make these cells~     from a healthy stem cell donor. If investigators are not able to collect blood from the stem~     cell donor, they will collect blood from the subject to make the CD19/CD28 chimeric~     receptor-T cells.~      These CD19/CD28 chimeric receptor T cells are investigational products not approved by the~     FDA.~      The purpose of this study is to find the biggest dose of chimeric T Cells that is safe, to~     see how long T cells with this chimeric receptor last, to learn what the side effects are,~     and to see whether this therapy might help people with lymphoma or leukemia after a stem cell~     transplantation from a donor.~   "
115907|NCT02050334|"~     The purpose of this study is to see if CC100, given by mouth, is safe and is tolerated in~     increasing doses. How long the drug remains in the body will also be calculated.~   "
115908|NCT02050321|"~     We propose to conduct a phase 2 study to assess whether the addition of acitretin to~     vemurafenib therapy is able to decrease the rate of cutaneous squamous cell carcinoma (cSCC)~     development, a known side effect of vemurafenib therapy, in patients with advanced melanoma.~     Further, we seek a preliminary assessment as to whether the addition of acitretin to~     vemurafenib enhances the clinical efficacy of this anti-melanoma agent.~   "
115910|NCT02050295|"~     Injecting local anesthetic to anesthetize a nerve or group of nerves (a 'nerve block') is an~     effective way to eliminate pain during and after surgery. There are instances when it would~     be beneficial to the patient for the nerve block to be resolved quickly rather than waiting~     for it to naturally wear off. For example, a sciatic nerve block that freezes the lower leg~     and foot typically takes over 18 hours to resolve on its own, and both the surgeon and~     patient prefer to have motor function before discharge. The investigators wish to perform a~     randomized, controlled trial to determine if infusion of a solution such as saline to 'wash~     out' the nerve block after surgery can allow the patient to be pain-free while still being~     able to move their leg and foot.~   "
115911|NCT02050282|"~     Breathlessness is a dangerous symptom. Preliminary data from national and regional Danish~     databases show, that patients with shortness of breath in the ambulance have a very high~     mortality. Breathlessness can be caused by many different conditions - but heart diseases and~     lung diseases are dominant. The mortality is especially high in patients with breathlessness~     caused by heart disease.~      Distinguishing these different causes of breathlessness is a classical, often difficult,~     discipline in medicine. Visitation and guidance of treatment in patients with breathlessness~     in the prehospital setting relies on medical history and physical examination and as a~     consequence prehospital treatment for breathlessness is often non-specific. The use of~     heart-failure specific biomarkers may improve prehospital visitation and treatment of~     patients with breathlessness.~      We hypothesize, that~        1. Supplementing the routine examination by prehospital anesthesiologist with measurement~          of a biomarker for heart failure increases the proportion of patients with severe~          shortness of breath caused by heart disease triaged directly to department of cardiology~        2. This strategy does not increase the proportion of patients with severe shortness of~          breath caused by non-heart disease triaged directly to department of cardiology~   "
115912|NCT02050269|"~     The objective of this study is to assess the feasibility of estimating the clearance of~     iohexol as an indirect measure of glomerular filtration rate in patients with unstable renal~     function in the intensive care unit through analysis of rich iohexol plasma kinetics.~   "
115913|NCT02050256|"~     Background: Optimizing the basic palliative care has been shown beneficial to patients in~     end-of-life care, the general practitioner (GP) having a pivotal role in the health care~     system, providing comprehensive and continued medical care.~      The aim of the study is to investigate the effect of a complex intervention in general~     practice on GPs' awareness of and confidence in providing end-of-life care.~      Method: A follow-up study among 404 general practices in Central Denmark Region. The~     participating general practices will get the opportunity to receive education in palliative~     care and access to an electronic support, which provides advice on palliative care and an~     overview of the palliative population in each medical practice. The education and the support~     will focus on patients suffering from either metastatic cancer or chronic obstructive~     pulmonary disease (GOLD stage 4).~      The end-of-life care delivered by the GPs to their deceased patients will be analysed, based~     on questionnaires to GPs and register data related to the deceased patients before and after~     the intervention, .~      Primary outcomes: Place of death of deceased patients, time spent at home, and number of~     hospital admissions in the last three months of the patients' lives.~      Secondary outcomes: Number and kinds of contacts between GPs and patients, use of relevant~     medicine and of the 'Safety Box'. Finally GPs' confidence concerning palliative care will be~     assessed in questionnaires.~   "
115914|NCT02050243|"~     Surgery is the cornerstone treatment of most pediatric CNS tumors, including astrocytomas,~     ependymomas, medulloblastomas, and many other pathologies.~      In most pediatric CNS tumors, the aim of surgery is maximal tumor resection, while preserving~     neurological function. Extent of tumor residual has been shown to be a major prognostic~     factor for progression free survival (PFS), and survival in several malignant and low-grade~     tumors such as medulloblastomas, ependymomas, and astrocytic tumors.~      5-aminolevulinic acid (5-ALA) has been shown to be valuable in intraoperative marking of~     various cancers. Following oral admission, during surgery, the tumor tissue is illuminated by~     blue light. Tumor cells tend to metabolize 5-ALA to a porphyrin named protoporhyrin IX~     (PpIX). PpIX reacts with the blue light and emits a pinky color (- fluorescence). This~     enables the surgeon to better identify tumor cells and perform a more extensive resection.~      Over recent years, many studies have proven the efficacy using 5-ALA for resecting various~     intracranial and spinal tumors, thus achieving a better tumor control.~      In the suggested study, we propose using the same technique for various pediatric central~     nervous system tumors.~      We will focus on the correlation between various pathologies and the fluorescence, trying to~     deduce the role of 5-ALA in resection of specific pathologies.~      Also, we will study the safety of 5-ALA use in the pediatric population.~   "
115915|NCT02050230|"~     Transfusion of stored blood has been associated with increased pulmonary vascular resistance~     in lambs. The investigators hypothesize that transfusion of one unit of red blood cells~     stored under standard conditions in intensive care patients will increase pulmonary arterial~     pressure and pulmonary vascular resistance to a greater extent than will one unit of fresh~     red blood cells.~   "
115916|NCT02050217|"~     Neurally Adjusted Ventilatory Assist (NAVA) is a new form of partial support wherein the~     machine applies positive pressure throughout inspiration in proportion to the electrical~     activity of the diaphragm (EAdi), Because ventilator functioning and cycling are under~     control of the patient's respiratory drive and rhythm, NAVA has the potential to enhance~     patient-ventilator interaction ensuring synchrony and minimizing the risk of over-assistance.~     Among different interfaces, the pediatric helmet is better tolerated than facial or nasal~     mask, thus requiring less sedation and allowing more prolonged ventilatory assistance~     (5-6).To date, no data exist on the use of NAVA in infants during noninvasive ventilation.~     The aim of this physiological study is to compare patient-ventilator interaction in infants~     receiving NIV by NAVA and Pressure Support Ventilation (PSV) with helmet.~   "
116014|NCT02048943|"~     This phase I trial studies the highest and safest doses of dovitinib lactate, paclitaxel~     albumin-stabilized nanoparticle formulation, and gemcitabine hydrochloride when given~     together. Dovitinib lactate disrupts the activity of fibroblast growth factor receptors and~     reduces cancer growth and spread. Gemcitabine hydrochloride and paclitaxel albumin-stabilized~     nanoparticle formulation are anti-cancer drugs for treating many cancer types.~   "
115918|NCT02050191|"~     This study supports the development of a diabetes prevention and control community web~     portal. The portal will feature an innovative personalized impediment profiling tool and~     reward program. The program, Nutrition Navigation on-Line Edge, or NnoLEDGE, will be used~     by community consortiums for weight loss and diabetic health interventions within their~     communities.~      The Specific Aims are:~        1. Recruitment of local community organizations to participate as a community health~          consortium~        2. Development of a comprehensive community health web portal consisting of a web portal,~          impediment profiler, community toolbox, and rewards system~        3. Final evaluation of the system with regard to participants' attitudes and perceptions of~          using NnoLEDGE as a tool for weight control and diabetes prevention to determine~          feasibility.~   "
115919|NCT02050178|"~     This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and~     PK of OMP-54F28 when combined with nab-paclitaxel and gemcitabine. OMP-54F28 will be~     administered IV on Days 1 and 15 of each 28-day cycle. Nab-paclitaxel (125 mg/m2) and~     gemcitabine (1000 mg/m2) will be administered IV on Days 1, 8, and 15 of each cycle. The~     planned dose levels of OMP-54F28 are 3.5 mg/kg and 7.0 mg/kg.~   "
115920|NCT02050165|"~     Proposed is a parallel-design randomized controlled trial to compare the effects of consuming~     two types of snacks on a daily basis for a 12-week period on health outcomes, diet quality,~     and self-reported satiety in a group of overweight adults. The types of snacks to be studied~     are KIND snack bars with almonds and typical American snack foods).~   "
115921|NCT02050152|"~     The investigators are conducting a study to investigate the amnestic effects of 2 different~     concentrations of nitrous oxide in children before induction of anesthesia in a prospective~     double-blinded placebo controlled study.~   "
115922|NCT02050139|"~     Over the last decades, peritoneal dialysis has grown worldwide to become one of the most~     common modalities of renal replacement therapy, particularly in developing or newly~     industrialized countries, such as India, China, Korea, Turkey, Malaysia, Mexico and Brazil.~     Peritoneal dialysis has been associated with an initial survival benefit compared to~     hemodialysis, although this advantage becomes less apparent over time, likely due to the~     progressive loss of residual renal function and the development of pathological alterations~     of peritoneum . Recent results suggest that an antioxidant therapy by N-acetyl-cysteine oral~     supplementation may improve residual renal function in peritoneal dialysis patients. This~     finding may have major clinical relevance, as preserving residual renal function in~     peritoneal dialysis patients has been associated with improved survival . Aim of the present~     randomized, double-blind, crossover study is to confirm the preliminary evidence of the~     beneficial effects of antioxidant agents on residual renal function by using the~     L-enantiomeric form of cysteine in 10 prevalent peritoneal dialysis patients with residual~     diuresis.~   "
115923|NCT02050126|"~     Ten (10) adult female subjects that had a caesarean surgery performed.Study will be conducted~     in 1 site.~      Each subject will receive three treatments on one area that was randomly chosen. The other~     area will be left untreated and will serve as a control.~      The objective is to Evaluate the clinical impact of UltraPulse fractional carbon dioxide~     laser treatment on the appearance of a Caesarean Scar (CS) as compared to a similar untreated~     scar side.~   "
115924|NCT02050113|"~     The purpose of this study is to evaluate the safety and efficacy of custom made devices,~     Zenith t-Branch devices and physician modification of FDA approved off-the-shelf endovascular~     grafts in the treatment of patients with complex abdominal aneurysms, aortoiliac aneurysms or~     thoracoabdominal aneurysms who (1) have anatomy not suitable for endovascular repair using~     grafts currently marketed in the United States,(2) are deemed unsafe to wait the required~     time necessary for commercial endograft manufacturing, and (3) are at high risk for open~     surgical repair.~   "
115925|NCT02050100|"~     The study goal is to collect blood samples from individuals at risk for lung cancer in order~     to identify protein markers for diagnosis of lung cancer in the Chinese population.~   "
115926|NCT02050087|"~     The study is a prospective randomized controlled non-inferiority trial where we elucidate the~     role of postoperative immobilization after arthroscopic rotator cuff repair.~   "
115927|NCT02050074|"~     Our primary hypothesis is that bile acid sequestrant colesevelam and the antidiabetic drug~     metformin potentiates the secretion of the gut hormone glucagon-like peptide 1 (GLP-1).~   "
115928|NCT02050061|"~     Chronic venous insufficiency (CVI) is a common disease affecting mainly lower limbs leading~     to significant impact on the quality of life. There is no study, to our knowledge, has~     attempted to evaluate the impact of compression stockings on all patients with CVI. Our aim~     is to estimate the prevalence of CVI in Qassim Region and to test the effectiveness of~     compression stockings.~   "
115929|NCT02050048|"~     The purpose of this study is to examine whether giving large amounts of intravenous (IV)~     fluids will reduce the risk of developing a complication known as post-ERCP pancreatitis~     (PEP). Pancreatitis is inflammation of the pancreas, and it is the most frequent serious~     complication of ERCP. Typically, a small amount of IV fluids are given during this procedure~     (~ 1 liter). We are testing whether using a larger amount of fluids (2 - 3 liters) will~     reduce the risk of PEP.~   "
115930|NCT02050035|"~     The purpose of this study is to investigate the effects of 12 weeks of aerobic exercise~     training on blood vessel function in Stages 1-4 Chronic Kidney Disease.~   "
115943|NCT02049866|"~     The purpose of this research study is to evaluate antiresorptive therapy with denosumab~     (Prolia) for prevention of bone loss after stopping teriparatide (TPTD) in premenopausal~     women with idiopathic osteoporosis.~      Premenopausal women who have received TPTD in the FDA Orphan Diseases Program-funded trial,~     A Phase 2 Study of Teriparatide for the Treatment of Idiopathic Osteoporosis in~     Premenopausal Women (NCT01440803) may be eligible to participate in the current study, a~     36-month open-label pilot study of denosumab (Prolia®, 60mg SC every 6 months).~      The goals of the study are to estimate the effects of denosumab on central and peripheral, as~     well as trabecular and cortical, bone mass and microstructure and to obtain preliminary data~     to inform the design of a future randomized study. This study presents the first opportunity~     to study the effects of denosumab after TPTD in this unique and severely affected group of~     young women.~      Funding Source - FDA OOPD~   "
116015|NCT02048930|"~     The aim of this study is to compare the clinical effectiveness and cost-effectiveness of the~     Easyhaler® (EH) device and other DPI devices commonly used in the UK in a UK primary care~     asthma population of patients aged 6 to 80 years.~   "
115931|NCT02050022|"~     Chronic Obstructive Pulmonary Disease (COPD) is a progressive disease that is characterized~     by loss of lung function, leading to breathlessness, poor quality of life, loss in~     productivity, and increased mortality. The World Health Organization estimates that COPD will~     be the third leading cause of death worldwide by 2020, accounting for more than 7 million~     deaths annually. COPD patients frequently experience 'lung attacks', during which~     breathlessness, coughing, and sputum production dramatically increase, leading to urgent~     office visits, emergency admissions and hospitalizations. Lung attacks reduce patient quality~     of life and cost the Canadian health care system nearly $4 billion dollars each year in~     direct and indirect costs. Lung attacks can be effectively managed if they are identified and~     treated early, but symptoms of a lung attack often overlap with those of other common~     conditions such as heart failure, pneumonia and even influenza. Because there are no tests~     that can separate lung attacks from these conditions, doctors struggle to accurately diagnose~     lung attacks at an early stage when drugs are most effective. This can lead to a delayed or~     even incorrect diagnosis and inappropriate treatment. This research will address this~     critical need. Our goal is to improve COPD patient care by developing new blood tests that~     will help identify patients who are in the early stages of a lung attack. Doctors will be~     able to use these tests to treat lung attacks at earlier stages than is currently possible.~     These blood tests will enable doctors to personalize management of COPD to meet the needs of~     the individual patient.~      Hypothesis: New biomarker blood tests can be used to better identify and manage patients with~     COPD.~   "
115932|NCT02050009|"~     This phase I trial studies the side effects and best way to give metformin hydrochloride,~     carboplatin, and paclitaxel in treating patients with recurrent ovarian, fallopian tube, or~     primary peritoneal cancer. Drugs used in chemotherapy, such as metformin hydrochloride,~     carboplatin, and paclitaxel, work in different ways to stop the growth of tumor cells, either~     by killing the cells or by stopping them from dividing.~   "
115933|NCT02049996|"~     The purpose of this study is to to determine if there is a difference in patient related~     outcomes of pain and quality of life following vaginal hysterectomy with vaginal prolapse~     repair compared to robotic-assisted repair.~      We hypothesize that pain and quality of life following robotic-assisted repair will be~     similar to that following vaginal reconstruction, when performed in conjunction with vaginal~     hysterectomy.~   "
115934|NCT02049983|"~     The purpose of this study is to determine the Levita Magnetic Grasper Device Safety and~     Performance in Laparoscopy.~   "
115935|NCT02049970|"~     the aim of this study was effect of the addition of dexmedetomidine to bupivacaine during~     supraclavicular brachial plexus blockade for forearm surgery, by low doses bupivacaine~     providing prolonged analgesia after surgery.~   "
115936|NCT02049957|"~     This is a phase 1b/2 study of the safety and efficacy of MLN0128 in combination with~     exemestane or fulvestrant therapy in women with estrogen receptor positive/human epidermal~     growth factor receptor 2 negative (ER+/HER2-) advanced or metastatic breast cancer that has~     progressed on treatment with everolimus in combination with exemestane or fulvestrant.~   "
115937|NCT02049944|"~     The purpose of this study is to determine whether an increased prophylactic dose (3 grams) of~     cefazolin at the time of cesarean delivery has superior coverage in adipose tissue than the~     current established dosing of 2 grams. The tissue and serum concentration values, when using~     an increased prophylactic dose, can then be compared to our pilot study assays in hopes of~     determining an optimal dosing for the obese and morbidly obese populations undergoing~     cesarean delivery.~      A previous study performed at University of California, Irvine (UCI) and Long Beach Memorial~     Medical Center/Miller Children's Hospital (LBMMC) showed that the standard dose of~     antibiotics (2 grams of cefazolin) did not provide adequate coverage for all organisms in the~     obese and extremely obese populations. The purpose of this research study is to evaluate~     whether in increased dose of antibiotics given before cesarean delivery (3 grams of~     cefazolin) will reach adequate levels in adipose (fat cells underneath the skin) and serum~     (blood) samples. In addition, researchers hope to evaluate if/how the mother's weight has an~     effect on the levels of antibiotics in the tissues (a group of similar cells).~      This follow up study (prior study HS# 2009-7015 at UCI) will enroll obese (Body Mass Index~     (BMI) of 30-40) and morbidly obese (BMI >40) women to receive an increased dose of~     prophylactic cefazolin at time of scheduled cesarean delivery at both UCI and LBMMC.~     Researchers hope to enroll a total of 35 women overall.~   "
115938|NCT02049931|"~     The treatment outcomes in the treatment without brace would be non-inferior to those in use~     of rigid or soft brace.~   "
115939|NCT02049918|"~     Collect de-identified, residual samples to support a clinical trial. Samples may be~     prospectively or retrospectively collected. Overall Study Objective Obtain clinical~     performance data to characterize clinical performance of the Respiratory Viral Panel on the~     GenMark Sample-to-Answer Platform.~   "
115940|NCT02049905|"~     The purpose of this study is to determine the efficacy and safety of aldoxorubicin in~     subjects with metastatic, locally advanced, or unresectable soft tissue sarcomas.~   "
115941|NCT02049892|"~     Does having a large diameter metal on polyethylene total hip replacement increase metal ion~     release. Larger metal heads are thought to have increased torsional forces on the trunion~     which would like release more metal ions. Increased metal ion levels have been associated~     with adverse local tissue reactions. Are there any differences comparing these groups to a~     dual mobility type total hip replacement.~   "
115942|NCT02049879|"~     The objective of this study was to objectively measure daily physical activity and~     spatiotemporal gait pattern, as well as improvements in self reported symptoms and quality of~     life, before and six weeks after an intra-articular corticosteroids injection in patients~     suffering from knee osteoarthritis. Fourteen patients with unilateral knee osteoarthritis~     were recruited. The intra-articular corticosteroid injection was given at the end of the~     second week. Physical activity was objectively measured by an accelerometer worn by the~     participants for eight weeks. In addition, the Western Ontario and McMaster Universities~     Arthritis Index (WOMAC), the Medical Outcome Study Short Form-36 (MOS-SF36) and gait trials~     were completed every two weeks to assess symptoms, quality of life and spatiotemporal~     parameters of gait.~   "
117157|NCT02034019|"~     To evaluate the safety and efficacy of OTX-DP as a sustained release drug (dexamethasone)~     depot when placed in the canaliculus of the eyelid for the treatment of post-surgical~     inflammation and pain in subjects who have undergone cataract extraction with intra-ocular~     lens implantation.~   "
115944|NCT02049853|"~     Acute dyspnea is a common chief complaint of patients presenting to the emergency department.~     Patients with acute dyspnea display a high mortality rate. In-hospital mortality is as high~     as 10% during hospitalization and up to 30% within 6 months of follow-up. The Triple A~     Initiative Study is designed to improve the coordination of care for patients with acute~     dyspnea alerting the Emergency Medical Service (EMS). We hypothesize that the coordination of~     care starting at the EMS level including point-of-care testing of the cardiac biomarker~     NTproBNP will support preclinical and clinical diagnostic clarification. Treatment deriving~     from earlier diagnostic clarification will reduce length of stay in the hospital, treatment~     costs and improve patient's outcome.~   "
115945|NCT02049840|"~     This is a prospective, post-market, single arm, multicenter study comparing Baseline data to~     the 12 month and 36 month data in 136 female patients with Stress Urinary Incontinence~   "
115946|NCT02049827|"~     Kidney transplantation is the treatment of choice for end stage renal disease (ESRD)~     improving the quantity and quality of life for dialysis patients. Although prolongation of~     graft survival in the short term by preventing the release is observed by immunosuppression~     (IS) powerful, the longer-term survival has not improved . Indeed, the IS can not only have a~     direct deleterious effect on the kidney transplant , but too weak IS can promote rejection,~     and too strong, promote the emergence of a viral disease polyomavirus BK ( BKV ) . BK~     nephropathy (BKVAN ) virus is accompanied by an irreversible impairment of the renal function~     , leading to a loss of the graft followed by a premature return to dialysis in at least 50 %~     of cases. Plasma BKV reactivation was observed mainly during the first year of~     transplantation in 15% of patients and complications annually BKVAN concern about 5 % of~     recipients . Currently , treatment options are very limited , only the decrease in IS shows a~     partially effective when care is early . There is no specific antiviral effective treatment~     of this disease . In addition, there is no way to predict which patients will develop BKV~     reactivation BKVAN despite lower tax.~      The diagnosis of interstitial nephritis BKV based on the detection of viral DNA by PCR and~     plasma is confirmed by histological analysis of renal tissue . Plasma quantitative PCR (~     qPCR) to measure the progression of the disease and therapeutic efficacy. Control of BKV~     viremia is the direct antiviral immune response quality based primarily on a very effective~     anti- T lymphocyte activity BKV reflection. In this context, the inhibition of lymphocyte~     activation induced by IS blocks the establishment of T-cell responses anti- BKV in most~     transplant, a very low presence of T lymphocytes is generally observed in these patients~     anti- BKV (LYT - BKV) blood .~      Our preliminary studies have validated in vitro a sensitive test to measure the functionality~     of blood LYT - BKV. This test is used to evaluate the concentration and functionality of LYT~     - BKV present in small volume of blood by measuring their specific proliferation after~     stimulation with peptide cocktails BKV. Proof of concept of the feasibility of this test was~     established on a small series of samples and highlights significant differences in lymphocyte~     anti-BKV different patients.~      Put to good use during the post-transplant follow-up, this type of test can provide the~     clinician with valuable data to assess the quality of anti- BKV T response compared to the~     intensity and type of IS treatment. Early identification of patients at risk of reactivation~     of BKV, or at risk of BKVAN if BKV viremia observed , would adapt the therapeutic response~     and monitoring arrangements at the fair. The objective of this project is to conduct a~     feasibility study to assess the relevance of post-transplant monitoring of anti- BKV T~     response of BKV viremic patients during the first year post- transplant. Immunological data~     will be analyzed in relation to virological data and bioclinical data.~   "
115947|NCT02049814|"~     The primary purpose of this study is to evaluate the efficacy of voglibose versus acarbose~     combined with Metformin in patients with type 2 diabetes mellitus (T2DM) by evaluating levels~     of glycosylated hemoglobin.~   "
115948|NCT02049801|"~     This phase I trial studies the MEK inhibitor MEK162 to see if it is safe in patients when~     combined with idarubicin and cytarabine. MEK inhibitor MEK162 may stop the growth of cancer~     cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy,~     such as idarubicin and cytarabine, work in different ways to stop the growth of cancer cells,~     either by killing the cells or by stopping them from dividing. Giving MEK inhibitor MEK162,~     cytarabine, and idarubicin may be an effective treatment for acute myeloid leukemia.~   "
115949|NCT02049788|"~     The objective of this study is to compare the effectiveness of a low-GI diet program and a~     standard counseling program in the treatment of obese Thai children.~   "
115950|NCT02049775|"~     Ulcerative colitis (UC) is a chronic inflammatory condition of unknown aetiology,~     characterized by a diffuse confluent mucosal inflammation of the colon starting from the~     rectum with a relapsing and remitting course. Conventional endoscopy was thought to be a~     reliable parameter of disease activity, but microscopic inflammation can persist despite~     normal mucosal findings. Histologically detectable inflammation is associated with a greater~     risk of subsequent relapse. A flare in UC activity is difficult to predict, but a simple,~     easily measured biological marker of relapse would be important in guiding the most~     appropriate therapy.~      Recent technological advances in fiber optics, light sources, detectors, and molecular~     biology have stimulated development of numerous optical methods that promise to significantly~     improve our ability to evaluate human epithelium in vivo. These methods, collectively termed~     optical biopsy, are nondestructive in situ assays of mucosal histopathology using light~     that can provide instantaneous tissue assessment. Narrow band imaging (NBI) is a novel~     technique that enhances the diagnostic capability of endoscopes in characterising tissues by~     using filters in a redgreenblue (RGB) sequential illumination system. This results in~     improved mucosal contrast and detail.~      UC always involves the distal colon and activity is usually greatest in rectosigmoid area.~     This makes evaluation of the rectum and sigmoid an attractive marker in patients with UC.~     Unlike serum and faecal markers, endoscopic assessment of the mucosa is unlikely to be~     affected by systemic disease and would be acceptable test for patients and physicians.~      We plan to evaluate THE rectosigmoid mucosa in patients with UC by flexible endoscope using~     both white light and NBI endoscopy. These patients will be followed by for one year or until~     they relapse, whichever comes first. The aim of our study is to develop endoscopic biomarkers~     to predict relapse in acute and quiescent UC.~   "
115951|NCT02049762|"~     Thus far, no study has evaluated the impact on aspirin in addition to the newer and more~     potent P2Y12 inhibitors, among ACS patients and current guidelines recommend dual~     anti-platelet therapy consisting of aspirin and a novel P2Y12 inhibitor in this population.~      Objective The investigators goal is to examine the effect of aspirin in addition to new~     anti-platelet agent (ticagrelor\prasugrel) on platelet reactivity in comparison with placebo,~     among ACS patients treated percutaneously.~      Design The proposed study is a randomized-controlled, double blind trial, conducted among ACS~     patients treated percutaneously. Eligible patients will recruited during hospitalization due~     to ACS after percutaneous coronary intervention (PCI), and randomization by envelopes on 1:1~     basis will take place a month after the index event, at a follow-up visit at the cardiac~     clinic.~      Platelet function and Endothelial function tests will be taken a month after the index event,~     and at a 2 weeks periods following aspirin/placebo therapy, cross-over and return to~     open-label aspirin.~      End-points platelet function tests will be compared between aspirin and placebo therapy and~     before and after the cross-over.~   "
115952|NCT02049749|"~     The purpose of this research study is to learn whether or not a brief parenting program~     called Child Adult Relationship Enhancement (CARE) offered at a primary care office can help~     improve behavior problems in children who are 2-6 years old.~   "
115953|NCT02049736|"~     Chronic kidney disease (CKD) and chronic viral hepatitis due to hepatitis B virus (HBV) are~     both major public health problems. Treatment of chronic HBV infection in CKD patients,~     however, is not well defined because of insufficient data from clinical trials. Telbivudine~     is a new antiviral that provides effective and sustained viral suppression in patients with~     compensated chronic hepatitis B infection. Unlike other nucleotide and nucleoside analogues,~     renal toxicity is uncommon in telbivudine, and dosage adjustment is not required in patients~     with mild renal impairment. We propose to conduct an open-label single-arm study to evaluate~     the effect of telbivudine on renal function and proteinuria in patients with chronic HBV~     infection and mild-to-moderate renal impairment. Twenty patients with chronic HBV infection~     and chronic kidney disease (estimated glomerular filtration rate 15 to 60 ml/min) will be~     recruited. They will be treated with telbivudine, with the dosage adjusted according to thei~     renal function, for 5 years. Serum HBV DNA, proteinuria, renal function, and urinary~     inflammatory markers will be monitored.~   "
115954|NCT02049723|"~     -  1. Research topic: How much do patients with GERD know about their own disease in Korea?~          (multicenter survey)~        -  2. Questionnaires for multicenter survey:~             1. Questionnaire 1 - include items for basic characteristics of participant patients~             2. Questionnaire 2 - modification of GERD knowledge test which was used in BMC Health~               Services Research 2008;8:236 (Prof. Jorgen Urnes)~        -  3. Subjects: patients with GERD in secondary or tertiary hospital~        -  4. Participant institutes: GERD club members, The Korean Society of~          Neurogastroenterology and Motility~   "
115955|NCT02049710|"~     The purpose of this study is to measure the effects of an interactive video on adolescent~     risky behaviors and outcomes, with one video intended to reduce teen pregnancies and the~     other intended to reduce automobile accidents.~   "
115956|NCT02049697|"~     The purpose of this study is to investigate the absorption, metabolic pathways and excretion~     of JNJ-39823277 in healthy male adults after administration of a single oral dose of a 25 mg~     (0.5 mg/mL solution) of 14C-JNJ-39823277.~   "
115957|NCT02049684|"~     Rotator cuff tears (injury to the muscle or tendons which stabilise the shoulder) are one of~     the most common conditions affecting the shoulder. Small and medium sized rotator cuff tears~     can be managed with arthroscopic or keyhole surgery. Very large or massive tears are~     difficult to operate on and often have poor rates of healing. As a result surgeons have~     investigated the use of products to improve the outcome of surgery on massive tears.~      The product that the investigators are currently using to try to improve the outcome of~     surgery for massive rotator cuff tears is called a patch. The patch provides a scaffold to~     support the muscles of the rotator cuff. Studies of rotator cuff surgery using similar~     patches have found that recovery is improved and there is a lower rate of postsurgical~     problems. The aim of this study is to look at whether using the patch improves pain and the~     clinical function of the shoulder after surgery. In addition, the investigators would like to~     understand how the patch works. To do this the investigators will scan (take images of) the~     shoulder using magnetic resonance imaging to look at the muscle damage in the shoulder before~     and after surgery.~   "
115958|NCT02049671|"~     Large population studies of hypopituitary adults (patients with pituitary gland failure) on~     conventional hormone replacement, but not growth hormone, have an approximate two fold~     increase in death rate (mortality). The vast majority of this excess mortality relates to~     vascular disease. While it is possible that overreplacement with steroids, underreplacement~     with thyroid hormones and sex hormone deficiency contribute, there are increasing data to~     support a role for GH in the cause of the excess vascular risk. Although a number of~     surrogates of vascular risk are described in patients with GH deficiency (GHD), how these~     translate mechanistically into atherothrombotic (blockage of the arteries) disease has not~     been fully elucidated.~      This proposed study will analyse both traditional (body composition, serum lipids, handling~     of sugars)and more complex markers (inflammation, procoagulation, fibrinolysis) of vascular~     risk/disease. In addition the study will examine 24hr blood pressure, arterial wall~     thickness, clot structure and function, as well as platelet action. Measurements will be~     performed at baseline and will be reassessed after patients have been on a stable dose of GH~     replacement for at least three months.~      The results of the study will characterise risk factors for vascular disease, and take this a~     step further to elucidate how these changes translate mechanistically in to vascular damage.~   "
115959|NCT02049658|"~     Previous studies have demonstrated that sniff dogs can identify cancer patients from healthy~     subjects through sniffing exhaled breath air or blood or serum or urine or feces. It is~     hypothesized that sniff dogs may be used as a tool in identifying cancer patients in the high~     risk population or suspected patients. Trained dogs will sniff serum from participants who~     are suspected to suffer from tumor by their physicians and not yet but will be diagnosed by~     pathological examination.The results will be compared with the outcome of the pathological~     examination.~   "
115960|NCT02049645|"~     Previous studies have demonstrated that sniff dogs can identify cancer patients from healthy~     subjects through sniffing exhaled breath air or blood or serum or urine or feces. It is~     hypothesized that sniff dogs may be used as a tool in screening cancer patients in health~     examination. Trained dogs will sniff serum from participants who are attending the annual~     health examination to identify potential or high risk subjects, and the results will be~     compared with the outcome of the traditional health examination, and the high risk subjects~     will be followed periodically for at least five years.~   "
115961|NCT02049632|"~     Sentinel node (SN) biopsy in breast cancer has been demonstrated to be a reliable method, and~     several follow-up studies have shown that it is safe to refrain from completion axillary~     clearance (axillary lymph node dissection, ALND) in SN-negative patients. SN biopsy alone~     results in significantly less arm discomfort following the operation.~      However, as a surprisingly low frequency of axillary relapse has been observed in patients~     without any axillary intervention (neither SN biopsy nor axillary clearance), or without~     completion ALND after a positive SN biopsy, the importance of ALND is being questioned, even~     for patients with SN metastases. A large, randomized study (ISBCG23-1) was not able to show~     any differences in 5-year disease-free survival between patients with SN micrometastases who~     had undergone ALND and those who had not.~      This Swedish multicenter study will include patients with SN micrometastases. These women~     will not undergo ALND but will be registered in a study cohort. The patients will otherwise~     be treated in accordance with the national guidelines and will be clinically followed every~     year for five years, after 10 years and finally after 15 years. Hypothesis: To refrain from~     axillary clearance in breast cancer patients with sentinel node micrometastases does not~     impair survival.~   "
115962|NCT02049619|"~     The purpose of this study is to determine whether pharyngeal packs can reduce nausea and~     vomiting in patients undergoing orthognathic surgery.~   "
115963|NCT02049606|"~     This is a randomized, double-blind study to compare the efficacy and safety of LAYLA tablet~     and CENATONE tablet in the treatment of osteoarthritis of the knee.~   "
115964|NCT02049593|"~     This phase I trial studies the side effects and the best dose of poly (adenosine diphosphate~     [ADP]-ribose) polymerase (PARP) inhibitor BMN-673 when given together with temozolomide or~     irinotecan hydrochloride in treating patients with locally advanced or metastatic solid~     tumors. PARP inhibitor BMN-673 may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth and may help temozolomide and irinotecan hydrochloride work~     better by making tumor cells more sensitive to the drug. Drugs used in chemotherapy, such as~     temozolomide and irinotecan hydrochloride, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving PARP inhibitor~     BMN-673 with temozolomide or irinotecan hydrochloride may be an effective treatment for~     patients with advanced solid tumors.~   "
115965|NCT02049580|"~     Study to test feasibility and efficacy of T-replete Bone Marrow (BM), infused after a RIC~     regimen and post-transplantation Cyclophosphamide (Cy), in patients with poor prognosis~     lymphomas.~   "
115966|NCT02049567|"~     Traditional lenses for cataract patients are monofocal, meaning they offer clear distance~     vision, but that patients must wear eyeglasses or contact lenses in order to see clearly~     things that are close to them, such as a newspaper.~      The FluidVision™ lens that is being tested in this study is designed to allow patients to see~     far objects as clearly as with a regular lens, and also to see near objects more clearly than~     with a regular lens.~   "
115967|NCT02049554|"~     The aims of the intervention are:~        1. Assess the feasibility and effectiveness of preconception health care initiated by~          pediatric clinicians on outcomes including women's access to primary care and~          contraceptive services; contraception and rapid repeat pregnancy rate and interpregnancy~          interval; and women's immunization rate, control of chronic illnesses, nutritional~          status, smoking and substance use, mental health and violence exposure; child and family~          health.~        2. Assess the cost-effectiveness of preconception health care initiated in pediatric~          practices.~      The investigators will evaluate these outcomes with a clinic based trial comparing usual care~     to preconception care intervention.~   "
115968|NCT02049541|"~     This phase I clinical trial studies the side effects and the best dose of~     phosphatidylinositol-3-kinase (PI3K) inhibitor BKM120 when given together with rituximab in~     treating patients with relapsed or refractory low-grade B-cell lymphoma. PI3K inhibitor~     BKM120 may stop the growth of cancer cells by blocking some of the enzymes needed for cell~     growth. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways.~     Some block the ability of cancer to grow and spread. Others find cancer cells and help kill~     them or carry cancer-killing substances to them. Giving PI3K inhibitor BKM120 with rituximab~     may be an effective treatment for B-cell lymphoma.~   "
115969|NCT02049528|"~     The study is being conducted to compare how long 2 oral formulations (a reference and a test~     formulation) of CC-122 stays in the body, and whether taking the test formulations with a~     high-fat meal affects the absorption of that formulation. There will be 3 dosing periods in~     the study, one for each formulation and one for the test formulation + meal. The subjects~     will be asked to fast for at least 10 hours before taking the capsule formulations. During~     one of the periods, the subject will be asked to eat a high-fat meal 30 minutes before being~     given the capsule to swallow. Subjects will be randomly (by chance) assigned to a treatment~     sequence which will determine the order in which the subject will receive the reference~     formulation, the test formulation, and the test formulation + high-fat meal. Blood samples~     will be taken at intervals during the study to assess the amount of drug at those time~     points. Blood samples will also be collected at certain time points to determine the levels~     of special proteins that may help explain how CC-122 work.~   "
115970|NCT02049515|"~     A Phase 3 (extension) clinical trial to examine the efficacy of IPI-145 monotherapy or~     ofatumumab monotherapy in subjects with Chronic Lymphocytic Leukemia (CLL) or Small~     Lymphocytic Lymphoma (SLL) who experienced disease progression after treatment with IPI-145~     or Ofatumumab in Study IPI-145-07.~   "
115971|NCT02049502|"~     The purpose of this study is to test whether Fecal Microbiota Transplant (FMT) is a safe and~     effective treatment for people who have Ulcerative Colitis and have had an ileal pouch~     anastomosis.~      Ulcerative colitis (UC) is a type of inflammatory bowel disease (IBD) that may be caused by a~     person's immune system responding in an unusual way to bacteria normally found in the gut.~     Studies have shown that the gut bacteria in people with ulcerative colitis (UC) are different~     from the gut bacteria in people without ulcerative colitis (UC). Often, people with~     ulcerative colitis (UC) have fewer types of bacteria in their gut which can change the way~     that person's immune system works.~      This study is for people who have had a proctocolectomy with an ileal pouch anastomosis~     (IPAA) to treat ulcerative colitis (UC). More than 50% of people who have had an IPAA will~     develop a condition called pouchitis. Pouchitis is short or long-term inflammation of the~     ileal pouch that was created in order to store waste from your intestines. Patients with~     pouchitis are being asked to take part in this study.~      Currently, antibiotics, probiotics and prebiotics are used to treat pouchitis. However, it~     has been shown that probiotics are not very helpful once the patient stops taking them. In~     addition, antibiotics may cause unfavorable side effects. Fecal microbiota transplantation~     (FMT) is being studied as another form of treatment for patients with active pouchitis. Fecal~     microbiota transplantation (FMT) or stool transplant involves receiving a single fecal~     enema from someone who has volunteered to donate their stool.~      There are two purposes of this research study:~        1. To see whether or not fecal microbiota transplantation (FMT) is a useful treatment for~          patients with ulcerative colitis (UC) associated pouchitis~        2. To study the changes within the bacteria in the gut in patients with pouchitis (before~          and after study treatment) using stool, blood and urine samples~   "
115972|NCT02049489|"~     This study will evaluate a type of immunotherapy in which the patient's immune system will be~     stimulated to kill tumor cells. ICT-121 dendritic cell (DC)vaccine is made from patient's~     white blood cells. This vaccine will be tested in patients with recurrent glioblastoma to~     assess safety, tolerability and clinical response. Patient's white blood cells (WBC) will be~     collected from blood and cultured to yield autologous DC. The DC will be mixed with purified~     peptides from the CD133 antigen. The DC vaccine will be given back to the patient over~     several months. The goal is to stimulate the patient's immune system to CD133 to kill the~     patient's glioblastoma tumor cells.~   "
115973|NCT02049476|"~     The main purpose of this study is to evaluate whether or not the dexamethasone pellet~     (Ozurdex®, Allergan, Irvine, CA) can replace oral corticosteroid (e.g. prednisone) in the~     treatment of active sight-threatening, noninfectious intermediate and/or posterior uveitis in~     which immunosuppressive drug therapy is indicated.~      Uveitis is an inflammation inside the eye. Uveitis can decrease patients' vision if it is not~     treated.~      The dexamethasone pellet is an implant filled with a corticosteroid medicine. This therapy is~     approved by the Food and Drug Administration (FDA) for the treatment of intermediate and/or~     posterior uveitis.~      In this study investigators want to see if using the implant together with systemic~     immunosuppressive drug therapy can result in lower ocular side effect profile but is~     effective enough to replace the use of high-dose systemic corticosteroids in the treatment of~     active intermediate and/or posterior uveitis. Knowing the effectiveness and safety of these~     treatments is important because the kinds of uveitis being studied usually need to be treated~     for many years. This information may help researchers understand uveitis better and may~     suggest ways of improving treatment.~      Adult patients with intermediate and/or posterior uveitis for which immunosuppressive drug~     therapy with high-dose corticosteroid is planned may join.~   "
115974|NCT02049463|"~     Purpose: To investigate the different sound spectrum of carotid arteries and to analyze its~     relationship to the vessel disease, and to build a new biomarker about vascular disorder.~      Methods: To record the carotid phonoangiography with digital stereoscopy and analysis the~     spectrum with different algorithm such as FFT, wavelet, entropy, complexity, and HHT. The~     results will be correlated and comparison to the finding in clinical, carotid Doppler and~     duplex, CTA, MR, and catheter angiography.~      Statistics:~      The significance of difference between parameters was computed using t-tests or paired t-test~     etc. A p value <0.05 is defined as significant.~   "
116016|NCT02048917|"~     The purpose of this study is to find an optimal smoking cessation strategy in patients~     undergoing therapy for lung and head and neck cancers at selected cancer centers in Kentucky~     by delivering high quality smoking cessation to all enrolled patients. This study will also~     examine the feasibility of routinely implementing an array of smoking cessation strategies~     for this patient population.~   "
115975|NCT02049450|"~     Patients with severe thalassemia (thalassemia major) present with severe anemia that required~     life-long transfusion therapy, spleen enlargement that led to increased transfusion~     requirement, and other serious complications as early death, growth retardation, bone~     deformations and iron overload due to blood transfusions. Splenectomy can significantly~     reduce transfusion requirement in thalassemia patients, but it is associated with an~     increased risk of serious complications such as sepsis and thrombosis. Preliminary~     preclinical and clinical data suggested that JAK2 inhibition, by reducing spleen size, could~     improve hemoglobin levels, thereby eliminating the need for splenectomy and reducing~     transfusion requirement and related iron overload.~   "
115976|NCT02049437|"~     The study is a phase I/II, double-blind, placebo-controlled, randomized cross-over clinical~     trial of tocilizumab (TCZ) or placebo in HIV-infected subjects receiving antiretroviral~     therapy with suppressed viral replication and CD4+ T cell count ≥350 and ≤1,000 cells/mm3)~   "
115977|NCT02049424|"~     Outcome evaluation in patients who underwent transplantation with T-repleted bone marrow~     after post-transplantation cyclophosphamide~   "
115978|NCT02049411|"~     - Cognitive changes are related to aging, affecting the performance of older patients in the~     solution of problems and the execution of tasks.~      This phenomenon has been observed as a decline of neurophysiological domains, especially~     memory, and the velocity of thought.~        -  Anesthesia and surgery performed contributes to its development then, is named~          post-operative cognitive dysfunction (POCD). The incidence varies due to conditions of:~             1. Anesthesia and surgery.~             2. The time elapsed after surgery.~             3. The population studied, and the type of cognitive test employed.~        -  The aim of this study is to evaluate the changes around the Short Portable Mental Status~          Questionnaire (SPMSQ-E) after ketamine administration on ophthalmic surgery on the~          common conditions of geriatric patients, —comorbid and settings as minor surgery—.~   "
115979|NCT02049398|"~     Background:~      - Normal bacteria and other tiny organisms are found in healthy human mouths. These are~     called oral microbiota. It is unclear exactly how the oral microbiota may affect health. For~     example, if the microbial composition is abnormal, it may lead to mouth conditions like~     periodontitis. Researchers want to study how the microbiota changes over time. This can help~     them plan future disease studies.~      Objectives:~      - To see if and how oral microbiota change over time.~      Eligibility:~      - Forty adult employees of the National Cancer Institute Shady Grove.~      Design:~        -  For 12 hours before the first visit, participants will not eat or drink (except water).~          They will not brush, floss, use mouthwash, chew gum, eat lozenges or candies, smoke~          cigarettes, or chew tobacco.~        -  At the first visit, participants will:~        -  Be given a saliva collector. They will spit 2 mL of saliva into it.~        -  Fill out an online questionnaire.~        -  Every 2 months, participants will visit the clinic and repeat visit 1.~        -  The study ends after 1 year.~      Sponsoring Institute: National Cancer Institute~   "
115980|NCT02049385|"~     Background:~      - At least one third of individuals with major depressive disorder (MDD) remain~     treatment-refractory after receiving currently available antidepressants underscoring the~     urgent need for new antidepressant therapies. Of the novel pharmacotherapeutic strategies~     seeking to rapidly alleviate depressive symptoms, glutamatergic modulators have emerged as~     promising potential targets. The present study sought to examine the potassium (KATP) channel~     activator diazoxide as a possible treatment for MDD. Diazoxide increases glutamate uptake~     from the synaptic cleft by activating the KATP channel to chronically increase expression of~     the excitatory amino acid transporter (EAAT)-2 system in glial cells. Diazoxide is~     FDA-approved for the treatment of sulfonylurea-induced hypoglycemia, hypoglycemia due to~     hyperinsulinemia, and hypertension.~      Objectives:~      - To assess the ability of diazoxide, potassium channel activator, to improve overall~     depressive symptomatology in patients with treatment-resistant MDD currently experiencing a~     major depressive episode. The efficacy of a three-week course of diazoxide will be compared~     to three weeks of placebo. The MADRS will serve as the main outcome measure~      Eligibility:~      - Adults 18 to 65 years old with MDD who are currently depressed without psychotic features.~      Design:~        -  Study Phase I (Day -28 to 0):~           -- Screen and taper off medications (Days -28 to -14): Prior to consenting to this~          study, subjects will have undergone a screening consisting of laboratory tests,~          psychiatric and medical history, and psychiatric and physical examinations under~          protocol 01-M-0254, The Evaluation of Patients with Mood and Anxiety Disorders and~          Healthy Volunteers. After consenting to this study, patients will be tapered off~          medications. Medications allowed and not allowed are listed in Appendix 1. Patients will~          be reminded to report all drugs, OTC products, and other agents to the investigators so~          that they can screen to avoid interactions that might make participation unsafe or might~          confound the research results. Patients are expected to meet all inclusion and exclusion~          criteria before medications are tapered (which is usually 1-2 weeks long). Subjects who~          are not taking medications will enter the drug-free period directly. All participants~          must have a score of ≥20 on the MADRS at screening and baseline of Study Phase I.~          Subjects who do not have a score of ≥20 on the MADRS by the end of Study Phase I will be~          excluded and will receive standard treatment.~        -  Drug-free period (Day -14 to day 0):~           -- Subjects will begin a 2-week drug-free period prior to the administration of~          diazoxide or placebo.~        -  Study Phase II (Day 0 to 56):~             -  In this study phase, subjects will be blindly randomized to receive either~               diazoxide 200-400 mg/day (given BID) or a placebo administered daily by mouth for~               three weeks. All patients except those who have a 50% or greater decrease in MADRS~               from baseline at the end of the first cross over point will cross over. To avoid~               carry-over effects between the different test sessions, there will be an interval~               of 14-21 days, pending response to test session 1. Subjects will then be blindly~               crossed over to the second experimental condition (either diazoxide or placebo) for~               another three weeks. All subjects who discontinue the study or who complete study~               phase II will then receive either clinical treatment or the opportunity to~               participate in another research protocol. Patients maintaining response to~               treatment condition 1 after two weeks will receive an additional one week washout~               before being crossed over to condition 2.The total duration of the study is~               approximately 11-13 weeks. The duration of Study Phase I including the 14-day~               drug-free period is approximately 4 weeks. Study phase II is 8-9 weeks long. Thus,~               the total duration of the study is approximately 11-13 weeks, except for those~               patients who were unmedicated at time of entry into the study and therefore do not~               need to undergo the initial tapering off medications. Subjects will be required to~               be hospitalized during the entire study. Passes will be permitted if the subject is~               clinically stable and the pass does not interfere with the study or unit~               procedures.~   "
115981|NCT02049372|"~     Our aim was to establish a feasible method to prospectively register all tonsil~     surgery-related complications and to find their possible predictive factors. Our long-term~     objective is to create a surgical complication registration database, which would provide~     valuable information for quality assurance and give us a benchmarking tool to improve the~     results of this surgery in our department.~   "
115982|NCT02049359|"~     The purpose of this study is to determine the impact of two-way short message service (SMS)~     on glycemic control in low-income, poorly-controlled adult diabetic patients.~   "
115983|NCT02049346|"~     * Background: Despite extensive use, to the best of our knowledge, no trial has~     simultaneously compared the three currently used erythropoietin stimulating agents (ESAs) in~     a prospective manner, in treatment of anemia of end stage renal disease (ESRD) patients.~      * Patients and Methods: All haemodialysis patients in Qatar who were treated with short~     acting Epoetin alfa or beta were screened. Eligible patients were randomized, either to~     continue on the previous regimen of Epoetin, or to receive Darbepoetin alfa or continuous~     erythropoietin receptor activator (C.E.R.A) for a total period of 40 weeks. All groups were~     assessed at the end of the study for safety and efficacy parameters.~   "
115984|NCT02049333|"~     The purpose of this study is to assess and compare the mechanical angle opening in patients~     with angle closure due to a plateau iris configuration (elevated iris) using~     phacoemulsification combined with endoscopic cycloplasty versus treatment with~     phacoemulsification alone.~   "
115985|NCT02049320|"~     This is a descriptive retrospective study designed to measure the efficacy of remifentanil~     sedation and the ability to perform frequent neurological examinations of patients with~     traumatic brain injuries.~   "
115986|NCT02049307|"~     The purpose of this study is to evaluate the potential effectiveness of losartan (100mg~     daily) for reducing inflammation and improving immune recovery.~   "
115987|NCT02049294|"~     The purpose of this study is to investigate whether addition of Omalizumab enables a~     reduction in the dose of prednisone in patients with asthma and eosinophilic bronchitis.~      This will be a double-blind placebo-controlled, 3-centre, randomized parallel group trial~     divided into two sequential study periods.~      Period 1: After establishing the minimum dose of prednisone to maintain asthma control and~     maintain sputum eosinophils <3%, subjects will be randomized to either placebo or Omalizumab~     for 16 weeks (either once monthly for 4 months or every 2 weeks for 4 months).~      Period 2: standardised prednisone reduction at intervals of 4-weeks until there is a clinical~     and eosinophilic exacerbation or bothersome steroid withdrawal effects. If patients have an~     exacerbation, they will be treated with prednisone. This patient will continue on Omalizumab~     or placebo during the entire duration of the study but not continue the phase of steroid~     reduction.~   "
115988|NCT02049281|"~     This study will evaluate thrice weekly dosing with vintafolide to find the maximum tolerable~     dose. The primary study hypothesis is that administration of vintafolide to participants with~     advanced solid tumors will have acceptable safety and tolerability.~   "
116123|NCT02047513|"~     NEONAX is an interventional, prospective, randomized, controlled, open label, two sided~     survival phase II studies against a fixed survival probability, with an unconnected analysis~     of the results in both experimental arms.~      Determining the impact of 2 cycles of Perioperative nab-paclitaxel/gemcitabine followed by~     surgery and 4 cycles of adjuvant nab-paclitaxel/gemcitabine or 6 cycles of adjuvant~     nab-paclitaxel/gemcitabine on the Disease free survival (DFS) rate at 18 months post~     randomization~   "
115989|NCT02049268|"~     Nicotine and alcohol are frequently used together and their combined use contributes to more~     than half a million deaths each year, with more alcoholics dying from smoking-related~     diseases than from alcohol-related diseases. Using a new multi-modal MRI approach combined~     with data fusion, the investigators propose to study how nicotine modulates alcohol-induced~     changes in the function of brain circuits. The investigators hypotheses are:~        -  functional connectivity (FC) in the reward network, containing components of the~          mesolimbic dopamine system, will be altered by alcohol, and additional increases in FC~          will be observed if nicotine is also present (e.g., additive effects).~        -  co-administration of nicotine will counteract the effects of alcohol on FC in multiple~          brain networks, including visual, sensorimotor and motor brain circuits, that may be~          associated with the impairing effects of alcohol~   "
115990|NCT02049255|"~     Comparison the use of marcaine and chloroprocaine in rachianesthesia for a surgical~     correction of inguinal hernia. Comparision between acute and chronic (3 months and 6 months)~     pain.~   "
115991|NCT02049242|"~     The aim of study is to compare triple tourniquet vs. single tourniquet to reduce blood loss~     at open myomectomy.~   "
115992|NCT02049229|"~     The purpose of the prospective, randomized and a multicenter trial is to compare clinical~     outcome in patients presenting with ACS, treated with PCI using Optimax-BAS versus~     Synergy-EES.~      Second objective is to explore whether the Optimax-BAS use is superior compared with~     Synergy-EES use with respect of hard end points (cardiac death, MI and major bleeding).~   "
115993|NCT02049216|"~     People with osteoarthritis (OA) of the knee attending The Alfred hospital will be invited to~     participate in a randomised controlled trial comparing two different types of knee taping.~     Both groups will also be prescribed an exercise program to assist in management of their knee~     OA.~      Hypothesis are as follows:~        1. Participants treated with flexible tape with have greater reductions in pain and~          improvements on timed performance based measures when compared to those treated with a~          placebo tape.~        2. Participants in both groups will have clinically significant improvements in pain and~          timed performance based measures compared to their baseline scores.~   "
115994|NCT02049203|"~     This study will determine whether Ataciguat (HMR1766) is well-tolerated in patients with mild~     to moderate calcific aortic valve stenosis. The primary focus of these studies will be on~     changes in blood pressure and orthostatic tolerance (i.e., ability to stand up without~     passing out), and determining whether treatment with Ataciguat results in significant~     reductions in blood pressure in this patient population.~   "
115995|NCT02049190|"~     This is an open-label, randomized, parallel group two-stage phase 1-2 study with an~     escalation and an expansion component. This study will evaluate an extended-release (ER)~     formulation of onapristone in patients with prostate cancer in which Progesterone Receptor~     (PR) may be contributing to tumor progression. A companion diagnostic to select patients~     whose prostate cancer expresses the activated form of the PR (APR) is under development and~     will be implemented in this study; it may be used to further enrich the selection of the~     population based upon ongoing review of the results. Patients will be treated until~     occurrence of an intolerable safety issue, treatment failure, if patient elects to withdraw,~     or for non-compliance with either protocol-specified evaluations or onapristone treatment. An~     additional cohort of patients will be included at the recommended phase 2 dose to gain~     additional understanding of the onapristone safety profile and potential anti-cancer~     activity.~   "
115996|NCT02049177|"~     Human papilloma virus (HPV) is a recognised cause of some head and neck cancers. Important~     questions remain however, regarding the role of specific types of HPV, their effect on~     prognosis and different subtypes of oral, pharyngeal and laryngeal cancer, interaction with~     other risk factors (such as smoking and alcohol), and potential geographical differences in~     the effect of HPV.~      Via the Alcohol-Related Cancers and Genetic Susceptibility in Europe (ARCAGE) study, which is~     an international collaboartive case-control study conducted in 15 centres in 11 European~     countries, and pooling our results with the HPV-AHEAD consortium, we will conduct a~     systematic analysis of HPV subtypes known or suspected to be involved in head and neck~     cancer. This will involve investigation of HPV risk by tumour site (oral, oropharynx,~     hypopharynx, larynx), tumour stage, country, sex and age, and whether risk is modified by~     exposure to other known or suspected carcinogens including tobacco, alcohol and medical~     history.~      It is intended that this work will contribute to the development of evidence that may feed~     into treatment protocols for these cancers as well as evaluations of the feasibility for~     extending HPV vaccine programs.~   "
115997|NCT02049164|"~     The purpose of this study is to determine the effective dose or dose range of AR08 in the~     treatment of VMS in menopausal females.~   "
115998|NCT02049151|"~     This is a multi-center, double-blind, placebo-controlled, randomized, Phase 3 trial in~     subjects with unresectable stage III non-small cell lung cancer (NSCLC) who have demonstrated~     either stable disease or objective response following primary concurrent chemo-radiotherapy~     (CRT), comparing overall survival (OS) time in subjects treated with tecemotide versus~     subjects treated with tecemotide-matching placebo.~   "
115999|NCT02049138|"~     This is a Phase 2, multicenter, open-label extension study in RA subjects. The sub-study is~     to assess the impact of upadacitinib treatment (15 mg QD and 30 mg QD) with background MTX on~     immunological responses to Prevnar 13® in RA patients.~   "
116000|NCT02049125|"~     The purpose of this study is to test the accuracy of urinary neutrophil-gelatinase associated~     lipocalin (NGAL) and other biomarkers (plasma renin, norepinephrine) to predict acute kidney~     injury (AKI) development in patients with cirrhosis and bacterial infection and to predict~     response to AKI treatment with albumin and albumin with terlipressin in patients with~     suspected hepatorenal syndrome.~   "
116001|NCT02049112|"~     The purpose of this study is to evaluate the clinical efficacy, safety and acceptability of~     our new oral salivary equivalent in the relief of signs and symptoms related to mouth dryness~     as compared to two distinct moisturizing currently marketed oral sprays (Aequasyal® &~     Biotene®) in patients with xerostomia due to chronic hyposalivation.~   "
116002|NCT02049099|"~     To describe the current treatment practice during 12 months for previously treated patients~     diagnosed with haemophilia A or haemophilia B.~   "
117158|NCT02034006|"~     The primary objective of the study is to investigate current criteria driving re-treatment in~     patients affected by CNV secondary to PM and experiencing a relapse of the disease after the~     first administration of ranibizumab.~   "
116003|NCT02049086|"~     This proposal will develop and test an indicated prevention strategy, Screening, Brief~     Intervention and Referral to Treatment with Pain-Management advice (SBIRT-PM), in Veterans~     who have filed a claim for a (military) service-connected injury for which they have~     requested financial compensation. Although typically only an information-gathering,~     forensic-styled examination, the Compensation examination is a crucial point of entry to VA~     care. Objectives are:~        1. To finalize the procedures, manual, and training materials of SBIRT-PM. The goals of~          this stage will be (1) optimizing SBIRT-PM's appeal to Veterans concerned about their~          musculoskeletal conditions and their Compensation claims; and (2) finalizing the~          counseling materials and procedures.~        2. To conduct a randomized clinical trial comparing SBIRT-PM to a no referral arm and a~          pain module only arm.~   "
116004|NCT02049073|"~     Noise-induced hearing loss affects an estimated 5% of the worldwide population, with 30-40~     million Americans exposed to hazardous sound or noise levels regularly. Sources of noise may~     be occupational, blast noise, or recreational. Trauma to the inner ear can occur through~     transient hearing loss or permanent hearing loss. Although hearing recovers after temporary~     transient hearing loss, growing evidence suggests that repeated temporary transient hearing~     loss may lead to a permanent hearing loss. Currently, there are no treatments and there are~     no known medications that can be used clinically to prevent noise-induced hearing loss in~     humans.~      The long-term goal of this research is to find medications that can prevent noise-induced~     hearing loss. The purpose of the present pilot study is to evaluate zonisamide and~     methylprednisolone as medications to prevent temporary transient hearing loss in humans.~   "
116005|NCT02049060|"~     This is a prospective, open-label, mono-centric, phase I-Ib trial of Tivantinib in~     combination with Pemetrexed and Carboplatin as first-line therapy in patients with advanced~     or metastatic cancer suitable for a Carboplatin and Pemetrexed regimen as part of their~     specific therapy.~   "
116006|NCT02049047|"~     Given the high expression of IGF-1R and pAKT proteins in thymoma tissues, able to sensitize~     tumors to mTOR inhibition, and the anticancer activity of the mTOR inhibitors, clinical~     evaluation in thymoma and thymic carcinoma seems to be very interesting.~      Patients will receive continuous treatment with oral everolimus 10 mg once daily.~      Efficacy and safety profile of Everolimus will be evaluated.~   "
116007|NCT02049034|"~     Glucagon-like-peptide-1 (GLP-1) analogues are a new treatment for type 2 diabetes, which have~     recently been shown to have beneficial effects on weight, glycaemic control and postprandial~     triglyceride concentrations. Postprandial hypertriglyceridaemia, which is associated with an~     increased risk of cardiovascular disease, is a feature of type 2 diabetes.~     Hypertriglyceridaemia is due to excess triglyceride-rich lipoproteins (TRL) which consist of~     very low-density lipoproteins, (VLDL) synthesised by the liver which contain the higher~     molecular weight form of apolipoproteinB (apoB), apoB-100, and chylomicrons which are~     synthesised in the intestine in response to an intake of dietary fat and contain the lower~     molecular weight form of apoB, apoB-48. A recent study has shown that GLP-1 receptor~     signalling is required for the control of postprandial lipoprotein synthesis and secretion in~     hamsters and mice. GLP-1 was shown to reduce apoB-48 TRL production while a GLP-1 receptor~     antagonist increased apoB-48 TRL production.~      This study will investigate the effect of the GLP-1 analogue lixisenatide compared with~     placebo, in a double blind crossover study, on postprandial triglyceride metabolism in 12~     patients with type 2 diabetes. Chylomicron and VLDL production and clearance rates will be~     measured in a repeated meal study by labelling apoB-100 and apoB-48 and by labelling~     triglycerides using stable isotope methodology. Glucose flux in response to a mixed fluid~     meal will also be investigated using stable isotope methodology. Gastric emptying and post~     heparin LPL activity will be measured.~      The hypothesis is that i] lixisenatide will lower postprandial glycaemia due to a decrease in~     endogenous glucose output and an increase in glucose clearance by peripheral tissues as a~     result of an improvement in insulin sensitivity.~   "
116008|NCT02049021|"~     Introduction: In spite of recent advances in schizophrenia treatment, 30% of patients still~     do not respond properly to antipsychotic therapy. These patients are considered~     treatment-resistant or refractory, and the best choice for them is clozapine. However, even~     supported by the literature as the best known antipsychotic in terms of efficacy and rates of~     response, a considerable number of patients will still not respond to this treatment,~     remaining symptomatic and dysfunctional. These patients are classified as super-refractory~     (clozapine-resistent). In these cases, augmenting strategies are necessary, and some have~     been in use: typical and atypical antipsychotics, mood stabilizers, antidepressants and~     electroconvulsive therapy (ECT). Some studies have favored ECT, but no definitive conclusion~     has been drawn.~      Objective: Test the electroconvulsive therapy efficacy and safety as augmenting strategy to~     clozapine-resistant patients, as compared to placebo (sham ECT).~      Methods: This is a pilot double blind, placebo controlled and randomized study to assess~     electroconvulsive therapy efficacy as augmenting strategy to clozapine in super-refractory~     schizophrenia. The ECT treatment will be delivered with either a MECTA SPECTRUM 5000Q or~     4000Q device, and the procedure is under general anesthesia and monitorization, after~     informed consent. The Hospital will follow national protocols and regulations on ECT. Sham~     ECT consists in habitual patient preparation and sedation, without stimulation. Patients that~     fit inclusion criteria will have their clozapine blood levels dosed and undergo structured~     assessments at baseline, after 6 treatments and at the end of the cycle of 12 ECT sessions~     (thrice a week protocol). The assessments will be based on CGI (Clinical Global Impression)~     and PANSS (Positive and Negative Syndrome Scale) scales. All medication will be maintained,~     except lithium carbonate.~   "
116009|NCT02049008|"~     The treatment of aggressive periodontitis (AgP) represents a challenge for clinicians,~     because there are no standardized protocols for efficient control of the disease. The aim of~     this study is to evaluate the effect of multiple applications of antimicrobial photodynamic~     therapy (aPDT) as an adjunct to non-surgical periodontal treatment (nsPT) in patients~     diagnosed with AgP. Twenty patients with a clinical diagnosis of AgP will be treated in a~     split-mouth design study to either aPDT associated with scaling and root planning (SRP) or~     SRP only. aPDT will be performed by using a laser light source with 690 nm wavelength~     associated with a phenothiazine photosensitizer. The applications will occur in four episodes~     (days 0, 2, 7 and 14). All patients will be monitored for 90 days. Clinical assessment of~     plaque index, probing depth, clinical attachment level and bleeding on probing will be~     performed at baseline (pre-intervention period) and 30 and 90 days after the nsPT.~     Subgingival plaque samples will be collected (at baseline and 30 and 90 days after the nsPT)~     and the counts of 40 subgingival species will be determined using DNA-DNA checkerboard~     hybridization. Gingival crevicular fluid samples will be collected (at baseline and 14, 30~     and 90 after the nsTP) for evaluation the volume of fluid (Periotron) and the levels of~     Interleukin 1 beta, Interleukin 10 and Tumor Necrosis Factor alpha (Luminex). Data obtained~     will be statistically analyzed.~   "
116017|NCT02048904|"~     The people being asked to participate in this study have type 2 diabetes and abnormal levels~     of protein in their urine. This indicates that they are starting to develop diabetic kidney~     disease. The standard treatment for this is the use of one of two blood pressure medicines,~     either an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker~     (ARB). However, these medicines are not always completely effective in stopping/reversing the~     kidney disease. Some studies have previously suggested that another type of medicine, called~     sitagliptin, normal used to treat diabetes may also help prevent diabetic kidney disease from~     getting worse.~      This study is being performed to test the effectiveness of sitagliptin as compared to a~     placebo, along with a stable dose of an ACE inhibitor or ARB, to determine whether or not it~     will reduce protein levels in their urine. Protein levels in the urine are a marker of the~     severity of kidney disease.~   "
116018|NCT02048891|"~     Ovulation trigger is needed in in vitro fertilization (IVF) to get mature eggs. Routinely,~     human chorionic gonadotropin (hCG) is used for that purpose given its similarity to the~     natural hormone that does this job in a natural cycle (luteinizing hormone, LH). In a natural~     cycle another hormone takes part in the process (follicle stimulating hormone, FSH). To~     induce a natural-like ovulation surge that includes LH and FSH , gonadotropin releasing~     hormone (GnRH) agonist can be given.~      The purpose of this study is to find out which approach may work better in IVF patients who~     experienced 4 IVF failures.~   "
116019|NCT02048878|"~     The purpose of this study is to determine whether individuals with chronic insomnia disorder~     have a higher degree of physiologic arousal (resulting in their trouble sleeping) than good~     sleepers. The primary goal is to perform a rigorous quantitative assessment of physiologic~     hyper-arousal across two domains (autonomic nervous system and neurophysiology) in patients~     with chronic primary insomnia as compared to good sleepers matched for sex, age, body mass~     index (BMI) and race/ethnicity.~   "
116020|NCT02048865|"~     Cancer patients have an increased risk of developing blood clots in the veins compared to~     non-cancer patients. Cancer patients who develop blood clots can lead to reduced life~     expectancy, delayed cancer treatment, and decreased quality of life. Prevention is the most~     effective way to decrease the complications associated with blood clots in the veins.~     Although previous clinical trials have shown some benefit on the use of medication to prevent~     blood clots in the veins in ambulatory cancer patients, these studies have been inconclusive~     in demonstrating that existing blood thinners significantly reduce the rate of blood clots in~     cancer patients. One possible explanation relates to the fact that these studies have~     included a large proportion of cancer patients who are a low risk of developing blood clots~     in the veins. We are proposing to identify cancer patients who are at a high risk of~     developing blood clots by using a validated tool at the time of their cancer diagnosis. The~     identified high risk cancer patients will be asked to participate in a trial to test the~     safety and efficacy of a new oral medication that has been used to prevent blood clots in~     patients undergoing surgery. We are enrolling 574 patients in 7 Canadian centers (Ottawa,~     Halifax, Montreal, Vancouver, Sault Ste. Marie, Toronto and Hamilton). 287 patients will~     receive the study drug and 287 will receive an inactive substance. Analysis will be performed~     to assess the safety and the superiority of the study drug.~   "
116021|NCT02048852|"~     This study examines the potential effect of reducing nicotine content or menthol or both in~     women of reproductive age, a vulnerable population identified by the FDA in need of further~     research.~   "
116022|NCT02048839|"~     SUBJECTS:~      All participants in the RADIEL-study (2008-2011) who delivered (n=535), will be invited to~     this follow-up study, with their children (age 3-5 years) and the father. The investigations~     are carried out during two separate visits. The father receives mail questionnaires~      OVERALL OBJECTIVES:~        1. To determine the long-term effectiveness of a lifestyle intervention in high risk women~          and their offspring a in reducing the incidence of T2DM and cardiovascular disease and~          their risk factors b in preventing obesity c on biomarkers d on genetic and epigenetics~          markers .~        2. To study the association between maternal diet during pregnancy and metabolic markers in~          the offspring at age 3-5 years.~        3. To study the association between maternal exercise habits during pregnancy and metabolic~          markers in the offspring at age 3-5 years.~        4. To study the association between maternal a) glucose-insulin metabolism b) lipid~          metabolism c) adipoinsulinar axis and d) inflammatory markers and birth size and later~          health outcomes in the mothers and their offspring.~        5. To study the association between gut microbiota and markers of offspring health~        6. To study associations between offspring cardiovascular morphology/function, offspring~          body size/composition, and maternal cardiovascular risk~        7. To study the cost effectiveness of the intervention.~      METHODS:~      Maternal measurements~        1. Height, weight, waist and hip circumference~        2. Blood pressure, pulse~        3. Body fat percentage~        4. Blood tests e.g. markers of glucose metabolism and lipids, vitamin D, Calcium and bone~          markers, DNA sample and inflammation markers~        5. Fecal and hair samples~        6. Diurnal salivary cortisol assessment~        7. Background questionnaire: socioeconomic and health-related background~        8. Health-related quality of life (15-D).~        9. 3-day food diary and exercise diary~       10. ArmBand (acceleration sensor), assessment of physical activity and sleep for 7 days~       11. Psychological questionnaires~       12. Pulse wave velocity (PWV) will be assessed~       13. Advanced glycation endproducts - a marker of cardiovascular health will be assessed~       14. Dental and oral health~       15. Bone health~       16. VHRU of arterial structure~      Paternal measurements~        1. Background questionnaire (incl. height, weight, age)~        2. DNA-sample (buccal)~        3. 3-day food diary~        4. Psychological questionnaires~        5. Physical activity questionnaire (12 months)~      Measurements of children~        1. Body weight, height, blood pressure, pulse~        2. Body fat percentage~        3. Psychological questionnaires~        4. Food and physical activities diaries~        5. ActiGraph, assessment of physical activity and sleep for 7 days~        6. Blood samples e.g. glucose- and insulin metabolism, lipids, vitamin D and calcium~          metabolism, DNA-sample and samples for inflammation markers~        7. Fecal, urine and hair samples~        8. A copy of child welfare center card (e.g. data on growth, immunizations, health)~        9. Endothelial function and pulse wave velocity (PWV)~       10. Bone health with peripheral CT~       11. Heart structure and function~       12. VHRU of arterial structure~      TIMETABLE~      Follow up starts in January 2014, and will continue until 2018. Data analysis starts in 2017~     and results will be reported from 2018 onwards in international peer-reviewed journals.~   "
116023|NCT02048826|"~     The purpose of this study is to determine the effectiveness of training hand movement using~     FINGER robot after stroke. FINGER is a robot that measures finger movements and allows users~     to play computer games using those movements.~   "
116024|NCT02048813|"~     This randomized phase III trial studies ibrutinib and rituximab to see how well they work~     compared to fludarabine phosphate, cyclophosphamide, and rituximab in treating patients with~     untreated chronic lymphocytic leukemia or small lymphocytic lymphoma. Ibrutinib may stop the~     growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as fludarabine phosphate and cyclophosphamide, work in different ways to~     stop the growth of cancer cells, either by killing the cells, by stopping them from dividing,~     or by stopping them from spreading. Monoclonal antibodies, such as rituximab, interfere with~     the ability of cancer cells to grow and spread. It is not yet known whether fludarabine~     phosphate, cyclophosphamide, and rituximab may work better than ibrutinib and rituximab in~     treating patients with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.~   "
116124|NCT02047500|"~     This is a multicenter, open-label, Phase 1, dose escalation trial to evaluate the safety,~     tolerability, and recommended Phase 2 dose (RP2D) of TH-302 in combination with gemcitabine~     and nab-paclitaxel in previously untreated subjects with locally advanced unresectable or~     metastatic pancreatic adenocarcinoma.~   "
116025|NCT02048800|"~     Every year around 70 children affected by cancer or life-threatening genetic diseases undergo~     haematopoietic cell transplantation (HCT) within the Blood and Marrow Transplant (BMT) unit~     at Great Ormond Street Hospital (GOSH).~      One of the main goals of the BMT unit over the last decade has been to reduce the morbidity~     and mortality related to HCT, and the group has become a world-leader in pioneering less~     toxic transplants.~      Fixed high doses of chemotherapy drugs are generally used to prepare children for HCT but~     several studies have shown a correlation between the concentration of these drugs achieved in~     the patient's blood, and the success or failure of the HCT procedure.~      Recently a new drug, Treosulfan, has become available for use in patients undergoing HCT, and~     GOSH has pioneered its introduction in children undergoing HCT. With promising early results,~     Treosulfan has become the pre-HCT drug of choice, however, very little is currently known~     about how the drug is metabolised and cleared from the body, particularly in children.~      The investigators therefore plan to investigate the pharmacokinetic (PK) profile of~     Treosulfan in children undergoing HCT at GOSH and define which parameters affect its~     metabolism and clearance, and what blood levels are associated with a favourable outcome~     (graft take without toxicity) or a poor result (graft rejection and/or toxicity).~   "
116026|NCT02048787|"~     To characterize the pharmacokinetics and safety of buparlisib following a single 50 mg oral~     dose in subjects with moderate and severe renal impairment.~   "
116027|NCT02048774|"~     Obesity is often cited as being inversely related with socioeconomic status (SES), although~     the mechanisms linking social status with obesity are not well understood. Dietary restraint,~     physical activity, and social mobility have been proposed as possible mechanisms. Although~     there is some evidence of SES variation in the proposed mechanisms, evidence is mixed and~     mostly observational. The purpose of this research is to determine if one's social position~     influences eating behaviors. This study will attempt to determine this using a randomized, 2~     parallel arm trial to determine the effects that social hierarchy positioning has on energy~     intake. To prevent compromise in the integrity of data, the investigators will detail the~     exact treatment condition (i.e., social positioning) after the data collection period.~      Based on findings from previous animal and large clinical observational studies, there are~     two complementary hypotheses tested in this study. First, it is hypothesized that being in a~     lower social position affects one's perception of food availability by making the future~     availability of food seem less certain. This uncertainty will lead to increased food~     consumption. Second, it is hypothesized that being in a position of power will lower one's~     food consumption, as previous research has found that individuals in power tend to east less~     in groups. Understanding how social position influences food intake could help improve weight~     loss/maintenance interventions by identifying unexpected factors that could limit the~     intervention's effectiveness.~   "
116028|NCT02048761|"~     This study was designed as a randomized, controlled clinical trial to evaluate the efficacy~     of 1% MF gel as local drug delivery in adjunct to SRP for the treatment of intrabony defects~     in chronic periodontitis in comparison with placebo gel.~   "
116029|NCT02048748|"~     Remote monitoring of chronic heart failure can reduce deaths and hospitalisations, and may~     provide benefits on health care costs and quality of life. Currently there is limited use of~     remote monitoring for heart failure in Norway. The funding streams and the structure of the~     norwegian health service is different from other countries that have tried remote monitoring~     and therefore it is important to examine the utility of such services in Norway. The study is~     a randomised controlled trial that will allow participants in the intervention group to use a~     wireless weight scale and blood pressure monitor device that will send automatically the~     measurements electronically and securely to the Heart Failure Outpatient Clinic of the~     hospital.~   "
116030|NCT02048722|"~     The purpose of this study is to see whether a drug called regorafenib might be effective in~     treating angiosarcoma. This study is for patients who have angiosarcoma that has gotten worse~     after they received chemotherapy. Regorafenib is a type of drug called a kinase inhibitor.~     Regorafenib interferes with how some kinase proteins work. Some of these kinases in cancer~     cells might normally help the cancer cells grow or form new blood vessels that could feed a~     growing tumor. By blocking these proteins, regorafenib may help stop the growth of certain~     cancers.~   "
116031|NCT02048709|"~     This is an open-label Phase I study to evaluate the safety, tolerability, and~     pharmacokinetics of escalating oral doses of GDC-0919, an investigational agent intended to~     inhibit the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme and help the human immune system~     attack solid tumor cells more effectively.~   "
116032|NCT02048696|"~     Patients who have suffered a heart attack are at risk of developing worsening heart function~     and heart failure. Exercise training has a beneficial effect on heart function and prevents~     heart failure. The aim of the current study is to investigate the effect of exercise training~     on heart function in patients who have suffered a heart attack.~   "
116033|NCT02048683|"~     Comparing a pharmacokinetic model of a short sevoflurane sedation in burn ICU patients with~     control ICU patients.~   "
116034|NCT02048670|"~     This pilot study is focused on what assistance an external prosthetic device, the~     BalanceBeltTM can provide in the: 1) assessment and 2) treatment for patients with Chronic~     Subjective Dizziness (CSD). The BalanceBelt has sensitive detectors for movement in the~     anterior/posterior and medial/lateral planes and provides the person wearing the device~     vibro-tactile feedback as to the persons orientation with respect to gravity. The device is a~     full self contained device that is comfortably worn around the waist over a light weight~     shirt. The device is non-FDA approved and is in its final stages of beta testing. Patients~     with CSD do not have permanent vestibular deficits, but underutilize vestibular signals~     because they develop visual or somatosensory dependence. The investigators expect the~     BalanceBeltTM to reset this error by providing patients with reliable motion stimuli.~   "
116035|NCT02048657|"~     Due to its soft cuff easily folded to impede ProSeal LMA insertion, many tools are developed.~     The aim of the study is to investigate the efficiency of ProSeal LMA insertion guided by a~     soft, direct optical Foley airway stylet tool (FAST) and compared with the standard~     introducer-tool (I-Tool).~   "
116164|NCT02046980|"~     To determine the short term therapeutic efficacies of Gufoni maneuver and mastoid oscillation~     in apogeotropic type of benign paroxysmal positional vertigo (BPPV) involving the horizontal~     semicircular canal (HC-BPPV), a randomized, prospective, sham-controlled study was conducted.~   "
116036|NCT02048644|"~     The investigator has recently studied markers of platelet activation in idiopathic pulmonary~     fibrosis (IPF) and found that in IPF patients there is a significantly increased platelet~     reactivity when compared with controls which is demonstrated by a concentration dependent~     increase in platelet-monocyte complex formation, platelet P-selectin expression and platelet~     fibrinogen binding in the presence of` the platelet agonists Adenosine diphosphate and L-~     Threonyl- L- phenylalanyl- L- leucyl- L- leucyl- L-argininamide (TFLLR).~      During platelet activation the platelets degranulate releasing numerous profibrotic cytokines~     including Transforming growth factor beta and Platelet derived growth factor that are~     recognised to be important in the pathogenesis of IPF. It is therefore plausible that the~     observed increased platelet reactivity in IPF contributes to the fibrotic process through~     local activation and degranulation with release of proinflammatory and profibrotic mediators~     within the pulmonary circulation.~      There is evidence that corticosteroid treatment may alter platelet adhesion, in a study of~     spontaneously hypertensive rat (SHR) increased circulating glucocorticoid, suppressed~     p-selectin expression. p selectin is a transmembrane protein present in the α granules of~     platelets. P selectin has a crucial role in platelet aggregation and platelet-leukocyte~     interactions, which are both potentially important mechanisms in the initiation and/or~     progression of tissue injury and development of thrombosis. In a study of patients with~     chronic obstructive pulmonary disease (COPD) exacerbation these were treated with either β~     agonists alone or β agonist and 40mg prednisolone and compared with a control group. At~     presentation the COPD patients had higher pulmonary artery pressure (PAP) higher p selectin~     and fibrinogen levels but lower Antithrombin III levels (AT III). The pulmonary artery~     pressure and fibrinogen levels were found to be significantly decreased in the steroid~     treated group whilst the p-selectin levels further increased in the non steroidal therapy~     patients.~      Rationale for the Current Study~      There is a significant unmet medical need for the treatment of IPF; the only medication~     approved for treatment of IPF in the United Kingdom (UK) is Pirfenidone and outside the UK~     there is none. The main goal of the current study is to evaluate the effect of Fostair on the~     biomarkers of platelet activation in IPF disease which the investigator believes play a~     pivotal role in the pathogenesis of IPF and whether this translates in to a clinically~     beneficial effect of Fostair on IPF disease.~   "
116037|NCT02048631|"~     The aim of the study is to investigate post-surgery sensory impairment and life quality~     changes in oral cancer patients who underwent free flap (Free Flap) on post-operative 6~     months, 12 months, and 24 months, respectively~   "
116038|NCT02048618|"~     -  180 patients suffering from active Crohn's disease with evidence of mucosal ulceration~          will be evaluated for improvement of disease activity (efficacy) when taking GLPG0634 or~          matching placebo once daily for 20 weeks in addition to their stable background~          treatment.~        -  During the course of the study, patients will also be examined for any side effects that~          may occur (safety and tolerability), and the amount of GLPG0634 present in the blood~          (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of~          action-related parameters in the blood and stool (Pharmacodynamics) will be determined.~          Also, the effects GLPG0634 administration on subjects' quality of life will be~          evaluated.~   "
116039|NCT02048605|"~     Patients with Parkinson's disease (PD) will be trained using a cognitive behavioral~     group-training-program to reduce stress and augment quality of life. An unspecific group with~     the same amount and frequency of meetings is used as a control group. For the evaluation of~     the training effects, scales to assess quality of life, analyses of psychopathological~     variations as well as neurocognitive tests will be used. Protocol amendment in 1-2017:~     addition of FU year 3 and year 5.~   "
116040|NCT02048592|"~     The primary objectives:~      To evaluate the effect of immunonutrition on the adult patient suffering from cystic fibrosis~        1. Safety of immunonutrition~        2. The effect of immunonutrition on parameters of oxidative stress~        3. The effect of immunonutrition on the inflammatory parameters~        4. The effect of immunonutrition on nutrition status~      Hypothesis~      The high oxidative stress is present in patients with cystic fibrosis. Immunonutrition has~     been shown to positively modulate oxidative stress in the different clinical setting however~     it has not yet been evaluated inpatients with cystic fibrosis who frequently need some~     support by means of enteral nutrition. We anticipate that the substitution of routine enteral~     nutrition by immunonutrition will result in improving of oxidative stress parameters.~   "
116041|NCT02048579|"~     Broadly, the purpose of the proposed study is to test the efficacy of a parent-coordinated,~     parent-teen-teacher collaborative intervention for middle school students with ADHD and~     academic impairment (STAND; Supporting Teens' Academic Needs Daily). [This model was chosen~     because of its potential ability to promote treatment maintenance and generalizability across~     school years, because parents will be taught to implement, monitor, and adjust intervention~     components as needed. Key innovative components in the STAND intervention address previously~     reported treatment barriers: 1) a parent-delivered academic intervention to promote~     maintenance and generalization across school years, and to relieve some of the burden of~     intervention delivery from teachers, 2) motivational interviewing to address parent~     disengagement from and adolescent resistance to the treatment process, 3) multiple tailored~     options for home-school communication, including a web-based support system, to facilitate~     home-school communication, and 4) empowering parents by coaching them to effectively and~     tactfully involve teachers in the treatment planning and monitoring process in order to~     increase teachers' willingness to support the child's academic needs. To study the~     feasibility and preliminary efficacy of the STAND treatment model,] two cohorts of 42 middle~     school students with ADHD will be recruited (total N=84) and randomly assigned to participate~     in STAND or a treatment-as-usual monitoring group. All participants will complete intake,~     mid-treatment, post-treatment, [and follow-up] assessments designed to monitor academic~     functioning, [intervention feasibility, compliance, and satisfaction].~      Aim 1: The proposed study will evaluate the efficacy, [maintenance, and cross-school year~     generalization] of a parent-teen-teacher collaborative intervention (Supporting Teens'~     Academic Needs Daily; STAND) vs. treatment as usual to increase the academic functioning of~     middle school students with ADHD. Intervention effects on ADHD symptomatology and impairment,~     grade-point-average (GPA), [organization, daily planner use], homework completion, teacher~     ratings of academic functioning and classroom behavior, and the parent-teen relationship will~     be examined.~      Aim 2: The proposed study will examine the acceptability and feasibility of the STAND~     program. Parents and teens will report on [satisfaction, barriers to treatment participation,~     therapeutic alliance, and treatment credibility] throughout the intervention and follow-up~     period. [Therapists will also complete ratings of parent and adolescent engagement and~     compliance with treatment procedures] will be collected from participants in the program.~     Parent, teen, and teacher compliance with intervention procedures will also be measured in~     order to assess feasibility. Treatment fidelity measures will also be collected in order to~     measure clinician adherence to the manualized STAND procedures.~      Aim 3: The proposed study will also explore ways to improve home-school communication during~     the middle school years. To this end, families will be given options regarding the modality~     of communication with teachers, and parent, teen, and teacher preferences for medium of~     intervention delivery will be examined (i.e., web-based, email, paper/pencil).~   "
116042|NCT02048566|"~     Hemodynamic management of critically ill patients is a constant challenge in the intensive~     care unit (ICU). Commonly used monitoring parameters to guide hemodynamic management~     generally consist of measurements of pressures (systemic and pulmonary artery pressures,~     cardiac filling pressures) and flow (cardiac output measurements using a thermodilution~     method). However, cardiac filling pressures and flow data have known limitations and might~     not accurately represent cardiac preload and contractility. Hemodynamic management of~     critically ill patients based on these parameters might therefore not be optimal and delay~     stabilisation of the patient, leading to negative outcomes and increased use of resources.~      Visualization of the heart using echocardiography offers the advantage of direct measurement~     of cardiac volumes and systolic function. Echocardiography has been established as a tool to~     evaluate the causes of hemodynamic instability in ICU patients by the visualization of~     cardiac chambers, valves and pericardium and cardiac functional abnormalities. A repeated~     echocardiographic assessment could potentially provide useful additional information~     resulting in more rapid resolution of hemodynamic instability. Using conventional TTE and~     TEE, however, limits the feasibility of such an approach due to a lack of time and~     availability of appropriately trained staff.~      In recently published studies the feasibility of hemodynamic monitoring and safety of hTEE~     was demonstrated. In the context of a prospective quality review assessment, the~     investigators showed that the echocardiographic examinations using hTEE were of sufficient~     quality in a majority of examined ICU patients and that the inter-rater reliability between~     the intensivists and a trained cardiologist was substantial. However, as of yet studies~     assessing the impact of hemodynamic monitoring by hTEE on relevant patient outcomes are not~     available. Given the associated costs for the hTEE device and the ultrasound probes and the~     additional resource requirements for training and application, the efficacy and efficiency of~     hTEE monitoring in comparison to standard monitoring should be established.~   "
116043|NCT02048553|"~     Background: Despite the widespread use of external ventricular drainage, revision rates and~     associated complications are reported between 10-40%. Current available image-guided~     techniques using stereotaxis, endoscopy or ultrasound for catheter placements remain~     time-consuming techniques. Recently, a phone-assisted guide with high precision has been~     described. The development of an easy-to-use, portable, image-guided system could reduce the~     need for multiple passes and improve the rate of accurate catheter placement. This study aim~     to compare prospectively in a randomized controlled manner the accuracy of the freehand pass~     technique versus an an easy-to-use, portable mini-tablet-assisted guide for ventriculostomy~     catheter placement.~      Methods/Design: This is a single center, prospective, randomized, trial with blinded endpoint~     (ventricle catheter tip location) assessment. Adult patients with the indication for~     ventriculostomy, as proven by computed tomography (CT), will be randomly assigned to the~     treatment group or the control group. In patients of the treatment group, ventriculostomy~     will be performed using a mini-tablet-guided assistance based on preoperative CT imaging.~     Patients in the control group will receive standard free-hand ventriculostomy using~     anatomical landmarks. The catheter may be placed for external drainage or internal~     (ventriculoperitoneal) shunting in both groups. The primary outcome measure is rate of~     correct placements of the ventricular catheter, defined as a score of 1 to 3 on grading~     system for catheter tip location on postoperative CT scan. Primary outcome will be determined~     by one of the authors (NS) blinded for treatment allocation. We aim to include 320 patients~     in 3 years.~      Secondary Outcome Measures include 1) Frequency of placements required, 2) Frequency of~     completed placements within the ventricle of the perforated part of the tip of the catheter,~     3) Frequency of very early and early shunt failures (revision of the ventricular drainage~     within 24 hours / within three weeks, 4) Frequency and Percentage of complications~     (procedure-related and nonsurgical) within three weeks, 5) Length of the trajectories from~     the dura level to the foramen of Monroe, the angle in the coronal plane towards midline (a)~     and towards the target (b) at the respective entry point, 6) ventricle size (the frontal~     occipital horn ratio (FOHR) and the width of the lateral ventricle in the coronal plane~     between the medial wall of the corpus callosum and the septum), 7) Differences (angles,~     distance of catheter tip from target) on the tablet-guided planned and postoperative~     trajectory on control computer tomography within 48 hrs (CT).~      Discussion: Here, we present the study design of a single center prospective randomized~     controlled trial to investigate whether tablet-guided application ventriculostomy is superior~     to the standard free hand technique. The strengths of this study are: 1. the prospective,~     randomized interventional character testing a new easy-to handle guided versus free-hand~     ventricular catheter placement, and 2. the power calculation is based on catheter accuracy~     using an available grading system for catheter tip location and calculated with use of recent~     study results of our own population, supported by data from prominent studies.~   "
116044|NCT02048540|"~     Background Local advanced gastric carcinoma (LAGC) is suggested to be potentially cured by R0~     resection, and neoadjuvant chemotherapy can increase the R0 resection rate but not enough.~     Bevacizumab (Bev), an anti-tumor angiogenesis monoclonal antibody, combined with chemotherapy~     has been shown effective in advanced GC. In addition, CTC has been suggested as an indicator~     of the anti-tumor drugs' efficacy. Therefore, in this study, the investigators plan to~     evaluate the efficacy and safety of neoadjuvant Bev plus docetaxel/oxaliplatin/5-FU/CF (DOF)~     versus DOF in mainly gastric antrum LAGC, and to investigate whether CTC is an effectiveness~     indicator.~      Methods 86 patients diagnosed as IIIb-IIIc GC have been enrolled and randomly assigned (1:1)~     to receive neoadjuvant Bev (5 mg/kg, d1) plus DOF (docetaxel, 75 mg/m2, iv, d1; oxaliplatin,~     85 mg/m2, iv, d1; 5-FU, iv infusion 600 mg/m2 and iv injection 400mg/m2, d1-2; CF, 200 mg/m2,~     d1 and d2) or DOF each 3-week, up to 2-4 cycles preoperation, and another 2-4 cycles~     postoperation up to total 6 cycles. The primary endpoint is R0 resection rate. CTC was~     detected every 8 weeks. All patients signed the informed consent.~   "
116045|NCT02048527|"~     Sequential culture media were introduced in order to meet the changing requirements of the~     developing embryo in vitro. However, there has been renewed interest in the use of~     single-step media, which allow the embryo itself to choose the necessary nutrients while~     maintaining a more stable culture environment. Previous studies suggest that sequential media~     do not appear superior to single-step media.~   "
116046|NCT02048514|"~     The purpose of this clinical study is to evaluate the safety and device performance of the~     Nellix® EndoVascular Aneurysm Sealing System (Nellix System) for the treatment of infrarenal~     abdominal aortic aneurysms.~   "
116047|NCT02048501|"~     The purpose of this study is to gain a better understanding of the mechanism of weight regain~     through gut hormone (substances in the gut that control various functions of the digestive~     organs) and energy expenditure (the amount of energy a person uses to complete bodily~     activities).~      Our hypothesis is that gut hormone response might be different among subjects who are able to~     maintain weight loss and subjects with weight regain.~      For this study, investigators will measure fasting and postprandial (happening after a meal)~     gut hormones, bile acid, amino acids, vitamin B, vitamin D, myokines and adipokine levels in~     obese individuals who are at least 2 years after a Roux-en-Y gastric bypass (RYGB).~     Investigators will also measure resting metabolic rate (RMR) (the amount of energy expended~     daily) and body composition (the proportion of fat, muscle, and bone of an individual's~     body). The subjects body composition will be analyzed, including fat mass and fat free mass,~     by a Dual-Energy X-ray Absorptiometry (DEXA). This study will provide more information~     regarding the effect of RYGB on gut hormones, adipokines, bile acids, amino acids, and energy~     expenditure and body compositions.~   "
116048|NCT02048488|"~     TSR-011 is a potent small molecule inhibitor of tyrosine kinases involved in cancer,~     including:~        1. Anaplastic lymphoma kinase (ALK)~        2. The tropomyosin-related kinases TRKA, TRKB, and TRKC~      This is a sequential, open-label, non-randomized study with dose escalation in Phase 1,~     followed by expansion at a recommended phase 2 dose.~   "
116049|NCT02048475|"~     To study the behavior of EEG during changing desflurane concentrations.~   "
116050|NCT02048462|"~     Many studies have shown that vigorous exercise increases the risk of developing vascular~     thrombotic events and can result in sudden death during or immediately after exercise. The~     outcome of these studies is biased by several confounding variables: subjects, type of~     exercise, duration, intensity and especially the method used for the evaluation of the~     hemostatic capacity. The goal of our study is to investigate the effect of strenuous exercise~     with the Calibrated Automated Thrombogram (CAT) assay, which is an established tool in~     detecting hyper- and hypocoagulabilty conditions. We modified the CAT assay to make it also~     feasible to measure TG in whole blood (WB-CAT), not only to go one step closer to physiology~     since all the blood cells are present, but also to avoid the centrifugation step. With our~     study we would like to see whether the other blood cells also play a role in the increase in~     TG. The objective is to investigate the effect of strenuous exercise (participation to the~     Amstel Gold Race) on coagulation and haemostatic parameters. We hypothesize that strenuous~     exercise induces a prothrombotic phenotype and that especially the tests involving blood~     cells will be altered into a prothrombotic phenotype.~   "
116051|NCT02048449|"~     Title:~      Inter-rater reliability of the reflux finding score based on endoscopic laryngeal findings in~     the diagnosis of laryngopharyngeal reflux disease~      Participants:~      Voluntary participants after invitation among members (a total of about 40~     gastroenterologists) of Gangwon Branch of Korean Society of Gastrointestinal Endoscopy and an~     otorhinolaryngologist~      Primary endpoint:~      Interrater reliability (Kappa coefficient) on the sum of reflux finding score more than 7~     points between an otorhinolaryngologist and gastroenterologists (7 points means the cut-off~     value for the diagnosis of laryngopharyngeal reflux disease)~      Secondary endpoint:~      Agreement (%) on 8 items of reflux finding score for laryngopharygeal reflux among~     gastroenterologists~   "
116052|NCT02048436|"~     The purpose of this study is to validate the accuracy of the Perminova N4 Monitoring system~     Respiration Rate technology.~   "
116053|NCT02048423|"~     1. Investigate the safety and effectiveness of a single dose of IV Ketamine for adolescents~          with suicidal ideation and depression. It is hypothesize that Ketamine will be well~          tolerated and significantly reduce depressive symptoms and suicidal ideation.~        2. Explore whether decision making as measured by the Iowa Gambling Task changes before and~          after Ketamine infusion. It is hypothesize that IV Ketamine infusion will significantly~          improve the decision making ability a measured by the Iowa Gambling Task in adolescents~          that are suicidal.~   "
116054|NCT02048410|"~     Probiotics have been proposed for the treatment of dyslipidemia. the investigators aimed to~     evaluate efficacy, tolerability and safety of a new symbiotic formulation containing a~     combination of probiotic and prebiotics and amine in the treatment of children affected by~     familial hypercholesterolemia (FH).~   "
116121|NCT02047539|"~     The primary objective of this study is to determine whether aspirin is effective in~     alleviating symptoms of the clinical high risk (CHR) syndrome for psychosis. The~     investigators further aim to determine whether it may delay or prevent the onset of psychosis~     in those currently experiencing CHR symptoms. As secondary measures the investigators aim to~     collect laboratory studies of inflammation markers and genetic samples to determine whether~     certain genetic profiles correlate with risk for psychosis, or response to aspirin treatment.~   "
116055|NCT02048397|"~     The effect of Pulmonary Rehabilitation in patients with bronchiectasis (BC) is not~     sufficiently studied. The aim of this study is to assess the clinical and biological response~     of a Pulmonary Rehabilitation Program (PRP) for 12 weeks in BC vs PRP plus hyperproteic oral~     nutritional supplement enriched with beta-hydroxy-beta-methylbutyrate (HMB).~      Methods: single center randomized controlled trial, parallel treatment design: Participants~     will be randomized assigned either will receive (n=14) PRP for 60 minutes, two supervised~     sessions per week in the hospital and one unsupervised session at home vs PRP (n=14) plus ONS~     (one can per day).~      Outcome assessments will be performed at baseline, 12 weeks and 24 weeks:~      1.- effort capacity &#8211;cardiopulmonary exercise test-, 2.- body composition~     (anthropometry, lean body mass by dual energy X-ray absorptiometry and bioimpedance, phase~     angle), 3.- peripheral muscle strength (dynamometry and respiratory -PEM (maximum expiratory~     pressure)and PIM (minimum expiratory pressure)-), 4.- spirometry, 5.- respiratory symptoms~     (bronchorrhea, dyspnoea, exacerbations),6.- level of physical activity (IPAQ questionnaire~     plus objective physical activity (WGT3X)), 7.- quality of life (QOL-B-Spain) ,~     8.-psychological symptoms (HASD) and 9.- biological markers of inflammation (leptin,~     adiponectin, interleukin-6, tumor necrosis factor-alpha, ultrasensitive C-reactive protein,~     GPR55 (G protein-coupled receptor 55) RNAm (messenger ribonucleic acid) expression in white~     blood cells) and oxidation (total antioxidant capacity, superoxide dismutase activity,~     8-iso-prostaglandin F2a, Thiobarbituric acid reactive substances).~   "
116056|NCT02048384|"~     This is a phase 1b, multi-center, open label, randomized study to evaluate the safety and~     feasibility of administering metformin with or without rapamycin after disease stabilization~     on chemotherapy in subjects with metastatic PDA.~   "
116057|NCT02048371|"~     Although regorafenib was approved for use in patients who had progressive GIST despite~     imatinib and/or sunitinib on the basis of phase II and phase III data, it has not been~     examined in a systematic fashion in patients with other forms of sarcoma.~      Given the activity of sorafenib, sunitinib and pazopanib in soft tissue sarcomas, and~     evidence of activity of sorafenib in osteogenic sarcoma and possibly Ewing/Ewing-like~     sarcoma, there is precedent to examine SMOKIs (small molecule oral kinase inhibitors) such as~     regorafenib in sarcomas other than GIST. It is also recognized that SMOKIs (small molecule~     oral kinase inhibitors)such as regorafenib, sorafenib, pazopanib, and sunitinib have~     overlapping panels of kinases that are inhibited simultaneously. While not equivalent, most~     of these SMOKIs (small molecule oral kinase inhibitors) block vascular endothelial growth~     factor and platelet derived growth factors receptors (VEGFRs and PDGFRs), speaking to a~     common mechanism of action of several of these agents.~   "
116058|NCT02048358|"~     In this first in human study the aim is to assess the safety, pharmacokinetics and~     pharmacodynamics of 2B3-201 in a randomized, first in human, double-blind, placebo- and~     active comparator- controlled 3-way crossover study in 18 healthy male subjects (part 1).~     Furthermore, the findings obtained from part 1 will be extended and confirmed in a subsequent~     parallel open label study in 18 healthy male and 12 MS patients and an open label study with~     methylprednisolone as comparator in 12 female volunteers (part 2).~   "
116059|NCT02048345|"~     The aim of this study is to understand the behavior of posaconazol gives as a suspension and~     solution in the gastrointestinal tract in human volunteers. The investigators know that~     supersaturation for this compound can be achieved by the influence of the gastrointestinal~     tract: The acid environment of the stomach creates a optimized environment for the basic~     compound to reach a high solubility, while the neutral environment of the small intestine~     creates a low solubility environment for the compound. The transit from stomach to small~     intestine gives the opportunity for the drug to create a supersaturated solution. Giving the~     drug as a solution to the healthy volunteer makes sure that precipitation is not occurring in~     the stomach and that precipitation has to happen in the small intestine. After all,~     supersaturation is a state that is not thermodynamic stable and always will want to~     precipitate. Giving the drug as a suspension to the healthy volunteers, can make it possible~     that still some particles of the drug are not in dissolution and that those particles will~     flow to the small intestine where other particles easily can bind to. This will make that~     almost the whole supersaturated solution is immediately precipitated.~      The investigators want to give the suspension by the authorized drug called Noxafil. On the~     other hand an aqueous solution will be made by adjusting the pH to 1.2 (which is conform with~     the pH of the stomach) and given to the volunteers by the stomach catheter. This 2~     formulations will be tested in a fasted state and a fed state (by giving 2 Ensure plus shakes~     to the volunteers before the experiment starts). After intake of the formulation, gastric and~     duodenal fluids will be aspirated by the catheters and analyzed at their laboratory. So the~     four conditions the investigators want to study are:~        1. 10 mL Suspension of posaconazol (Noxafil 40mg/mL) together with a glass of 240 mL water~          in a fasted state~        2. 250 mL solution of posaconazol, by dissolving 2.6 mL autohorized suspension (Noxafil) in~          247 mL water, adjusted to pH 1.2 by hydrochloric acid given to the volunteer in a fasted~          state.~        3. 10 mL Suspension of posaconazol (Noxafil 40mg/mL) together with a glass of 240 mL water~          in a fed state (by giving 20 minute before intake of the formulation, 2 ensure plus~          shakes)~        4. 250 mL solution of posaconazol, by dissolving 2.6 mL autohorized suspension (Noxafil) in~          247 mL water, adjusted to pH 1.2 by hydrochloric acid given to the volunteer in a fed~          state (by giving 20 minute before intake of the formulation, 2 ensure plus shakes).~      By getting more knowledge about the behavior of posaconazol (interplay supersaturation /~     precipitation) more insights can be achieved for the development of supersaturating drug~     delivery systems.~   "
116060|NCT02048332|"~     In this research study, we want to learn more about the use of donor-derived cytotoxic~     T-cells (CTLs) to treat viral infections that occur after allogeneic stem cell transplant. A~     cytotoxic T cell is a T lymphocyte (a type of white blood cell) that kills cells that are~     infected (particularly with viruses). Allogeneic means the stem cells come from another~     person. These CTLs are cells specially designed to fight the virus infections that can happen~     after a bone marrow transplant.~      We are asking people who have undergone or will undergo an allogeneic stem cell transplant to~     enroll in this research study, because viral infections are a common problem after allogeneic~     stem cell transplant and can cause significant complications including death.~      Stem cell transplant reduces a person's ability to fight infections. There is an increased~     risk of getting new viral infections or reactivation of viral infections that the patient has~     had in the past, such as cytomegalovirus (CMV), Epstein-Barr virus (EBV), adenovirus (ADV),~     and BK virus (BKV). There are anti-viral medicines available to treat CMV, EBV, ADV, and BK~     infections, though not all patients will respond to the standard treatments. Moreover,~     treatment of viral infections is expensive and time consuming, with families often~     administering prolonged treatments with intravenous anti-viral medications, or patients~     requiring prolonged admissions to the hospital. The medicines can also have side effects like~     damage to the kidneys or reduction in the blood counts, so in this study we are trying to~     find an easier way to treat these infections.~   "
116079|NCT02048085|"~     This study involves doing platelet function testing in patients who have undergone~     fibrinolysis. Fibrinolysis (Use of clot busting medicine in heart attack) is the standard of~     care to restore blood flow in blocked arteries as soon as possible after the Heart attack~     in rural health center where access to cardiac catheterization is one hour away. Fibrinolysis~     is done by the emergency room physician in a timely fashion to minimize the damage of the~     myocardium. Additionally anti-platelet regimen as adjuvant for patient undergoing~     fibrinolysis has been well studied in many trials. In this study investigators will use~     clopidogrel or ticagrelor in randomized fashion to evaluate anti- platelet effect by~     measuring efficacy in vivo (pharmacodynamics) and blood levels of both drugs~     (Pharmacokinetics).~   "
116061|NCT02048319|"~     Liver cysts are fluid filled cavities located in the liver. They are present in 2-11% of the~     general population, typically not causing any symptoms or complications. However, in a small~     subset of patients complaints of pain, abdominal fullness and distension, dyspnea and nausea~     occur.~      Currently, aspiration and sclerotherapy is a treatment of choice in symptomatic patients with~     a large dominant liver cyst. However, studies reported early fluid reaccumulation and~     relative high recurrence rates of cyst growth after aspiration sclerotherapy ultimately~     leading to re-interventions. In this respect, somatostatin analogues are promising agents~     known for its volume reducing effect in patients with polycystic liver disease.~      In this study the investigators want to evaluate the effect of combining aspiration~     sclerotherapy with the multi-receptor binding, long-acting somatostatin analogue Pasireotide.~      The investigators hypothesize that administrating pasireotide before and after aspiration~     sclerotherapy could prevent early fluid reaccumulation and thereby result in a greater~     reduction of cyst diameter. Moreover, the investigators expect a lower rate of cyst~     recurrence and subsequently lower need for re-interventions.~   "
116062|NCT02048306|"~     The purpose of this study is to explore the impact of Family-based pulmonary rehabilitation~     (PR) on patients with chronic obstructive pulmonary disease (COPD) and their family members.~      Dyads (patient and respective family member) will be randomly allocated to either a~     Family-based PR group or a Conventional PR group. PR programs will consist of exercise~     training and psychoeducation. In the Family-based PR program, both patients and family~     members will participate in psychoeducation sessions. In the Conventional PR group, only~     patients will be included. In both groups, exercise training sessions will be exclusively for~     patients.~      It is expected that, by including patients with COPD and their family members in Family-based~     PR, they will become more competent and confident in the management of the disease, thus~     reducing the overall impact of COPD on patients and family members' well-being.~   "
116063|NCT02048293|"~     Unbranded drug molecules are produced after the patent of a given drug has expired. Unbranded~     molecules of Remifentanil have been marketed in Colombia, and several reports by~     anesthesiologist indicate that there are differences in the physiologic response of patients~     to these molecules. The investigators hypothesized that unbranded molecules of remifentanil~     require higher doses to obtain desired physiological responses as compared to the branded~     molecule.~   "
116064|NCT02048280|"~     Neurally adjusted ventilatory assist (NAVA) is a mode of mechanical ventilation that uses the~     diaphragm's normal electrical activity to deliver a mechanically supported breath. The amount~     of support provided is determined in part by the NAVA level, where a higher NAVA level will~     provide higher level of support and unload more of the work of the diaphragm. The purpose of~     this study is to compare the optimal NAVA level in neonates while on mechanical ventilation~     while intubated and after being extubated.~   "
116065|NCT02048267|"~     Numerous treatment modalities have been proposed to treat pain in alcoholic and non-alcoholic~     chronic pancreatitis such as analgesic medication, inhibition of gastric acid production,~     enzyme substitution, somatostatin analogues, nerve blockade,reduction of oxidative stress and~     endoscopic pancreatic duct stenting, but none of these concepts have shown long lasting~     benefits as surgery in clinical studies.Comparison of surgical outcome in non-alcoholic~     chronic pancreatitis and alcoholic chronic pancreatitis has limited data and differences on~     the basis of outcome in between alcoholic and non-alcoholic chronic pancreatitis are not~     available in literature.~      Although it is well known that pain is the main symptom of chronic pancreatitis, it has until~     now been assessed in very common and varying categories. Pain, however, is only one aspect of~     the large variety of sensitive facets of daily life. In addition to an improvement in pain~     symptoms and the preservation of pancreatic exocrine and endocrine function and other~     parameters, occupational rehabilitation of these mostly young patients and quality of life~     also should be considered in the evaluation of surgical outcome in alcoholic and~     non-alcoholic chronic pancreatitis.~      In this prospective study, we intend to find out if there are any differences in the surgical~     outcome on the above mentioned parameters in alcoholic and non-alcoholic chronic~     pancreatitis.We also plan to see if there are differences in the histopathology in these two~     disease settings.~   "
116066|NCT02048254|"~     -  To compare the efficacy of Iodine-125 radioactive seeds implantation versus IMRT to~          treat inoperable salivary gland carcinoma.~        -  To compare the safety of Iodine-125 radioactive seeds implantation versus IMRT to treat~          inoperable salivary gland carcinoma.~   "
116067|NCT02048241|"~     Children with explosive aggression are often rejected by their peers, placed in special~     classroom, and contribute to family discord. When psychotherapy and family therapy is~     unsuccessful, medications are often used. Current medications are stimulants (e.g.~     methylphenidate, dextroamphetamine), anticonvulsants (e.g. Divalproex) and antipsychotics~     (olanzapine, risperidone). At this time, the available medications are of limited usefulness,~     either because they do not always work or because they have side effects such as weight gain~     or insomnia. There is a clear need for new medications to treat explosive aggression when~     psychotherapy is unsuccessful.~      The hypothesis of this study is the medication Intuniv when combined with psychotherapy will~     be more helpful to children with explosive aggression than placebo combined with~     psychotherapy. Intuniv is a long acting form of guanfacine, a medication approved by the FDA~     for treatment of Attention Deficit Hyperactivity Disorder. Intuniv is not a stimulant, nor is~     it an anticonvulsant, nor is it an antipsychotic.~      The children in this study will be between the ages of 6 and 12 and meet Diagnostic and~     Statistical Manual of Psychiatry Fourth Edition, Text Revision (DSM-IV-TR) criteria for~     Intermittent Explosive Disorder.~   "
116068|NCT02048228|"~     Clopidogrel, in addition to aspirin, is the cornerstone of therapy in patients suffering from~     Acute coronary syndrome. However, the platelet inhibitory response to clopidogrel varies~     substantially among individuals. Several loss‐of‐function polymorphisms have been identified~     that may influence clinical outcome in patients presenting with acute coronary syndromes~     (ACS) who are treated with clopidogrel. However their contribution to high on-treatment~     platelet reactivity (HPR) in clopidogrel treated Chinese patients is less known. As far as we~     know, ticagrelor is not dependent on gene-based metabolic activation and demonstrated greater~     clinical efficacy than clopidogrel in a recent secondary prevention trial. we will conduct an~     interventional study to compare the antiplatelet efficiency between clopidogrel and~     ticagrelor by the guidance of CYP450 2C19*2 (CYP2C19*2) , using Taqman genotyping method.~   "
116069|NCT02048215|"~     Brief Summary This trial was part of a sub-project targeted to diet, thermogenesis and~     obesity of a larger multicentre study named Interaction between nutritional,~     social-behavioral and metabolic factors for prevention of cardiovascular disease: development~     of nutritional strategies on general population.~      Ephedrine and caffeine (EC) combination has been widely used in human obesity treatment. It~     is known that this drug increases the metabolic rate in both animals and humans. Ephedrine is~     an agonist of both α and β-adrenoceptors; moreover, it induces norepinephrine release from~     sympathetic neurons. Caffeine increases both norepinephrine and dopamine release and~     stimulates the neuronal activity in several brain regions. We hypothesize that EC treatment~     might exert a specific effect on lipolysis and thermogenesis by stimulation of beta-3~     adrenoreceptors on adipose tissue and by stimulating uncoupling of oxidative phosphorylation,~     i.e. energy being dissipated as heat rather than being converted to adenosine triphosphate~     (ATP)~      Our study is a double-blind, placebo-controlled, 4-week trial to investigate the effect of~     hypocaloric diet alone or coupled to EC treatment of morbidly obese women on thermogenesis,~     expression of UCP 3 (in muscle tissue) and of beta-3 adrenoreceptors (in adipose tissue).~     Subjects are randomly assigned to EC (200/20 mg) or to placebo administered three times a day~     orally together with a energy-deficit diet (70% of resting energy expenditure), starting one~     month before undergoing bariatric surgery. Primary study endpoints are weight change analysed~     by intention to treat, changes in resting energy expenditure, UCP3 (long and short isoform),~     messenger ribonucleic acid (mRNA) levels in rectus abdominis and immunostaining for beta-3~     adrenoreceptors in subcutaneous and omental adipose tissue. Also plasma epinephrine,~     norepinephrine, triglycerides, free fatty acids, glycerol, TSH, free thyroxine (fT4), free~     triiodothyronine (fT3) fasting glucose, insulin and homeostasis model assessment (HOMA)~     index, are measured at baseline and at the end of treatments.~   "
116070|NCT02048202|"~     The study will compare intervention by Infant Aquatics to infant massage. The intervention in~     both methods will start at 36 weeks gestational age for 3 months and will consist of sessions~     with a therapist every 2 weeks. Development will be assessed and compared at 3, 8 and 18~     months using Infant Motor Pattern method, Griffith developmental scales and Vineland adaptive~     behavior scales.~   "
116071|NCT02048189|"~     This is an open multicentre, randomized study to compare two treatment arms. One arm called~     intensification of multiple injections in which the patient will receive one supplementary~     injection of LEVEMIR®: that is to say 5 injections per day, and an arm called continuous~     insulin infusion via an external pump with APIDRA®.~      In the pump arm: a favorable effect in terms of improved insulin sensitivity, improved~     metabolic equilibrium, a decrease in the area under the baseline and prandial hyperglycemia~     curve noted during the continuous glycemia recording; an improvement in quality of life~     compared with treatment using multiple injections.~   "
116072|NCT02048176|"~     Posterior fossa mutism (PFM) occurs in up to 30% of patients after resection of a posterior~     fossa tumor, most commonly a medulloblastoma. PFM is characterized by delayed onset of mutism~     1-6 days after surgery that can spontaneously improve on average from 7-8 weeks later. Few~     patients recover normal speech. Most of their speech continues to be marked by dysarthria,~     dysfluency and slowed rate. Researchers have not identified the pathophysiologic mechanism~     for PFM nor have they found a cure. Despite the improvements in speech, patients with PFM~     have shown multiple areas of neurocognitive deficits 12 months after diagnosis. Few studies~     have looked at long term outcomes of patients affected by PFM. We propose to survey patients~     who developed PFM after resection of a medulloblastoma to determine long term effects of PFM~     on patient's quality of life.~   "
116073|NCT02048163|"~     The purpose of this study is to compare the incidence of nausea and vomiting following short~     intermittent versus prolonged intermittent infusion of meropenem.~   "
116074|NCT02048150|"~     This pilot clinical trial studies the best dose of anti-prostate specific membrane antigen~     (PSMA) monoclonal antibody MDX1201-A488 (MDX1201-A488) given before surgery to aid in~     visualization of the prostate. Attaching a fluorescence, a substance that emits radiation~     that is visible, to the anti-PMSA antibody and injecting it into the body may help identify~     the tumor when specialized microscopes are used.~   "
116075|NCT02048137|"~     In the study we test whether transcranial direct current stimulation can reduce the~     perception of pain in patients with chronic inflammatory bowel diseases.~      Hypothesis: Transcranial direct current stimulation can reduce the perception of pain in~     patients with chronic inflammatory bowel diseases.~   "
116076|NCT02048124|"~     Background: There is an ongoing interest in developing Endoscopic Ultrasound /Fine Needle~     Aspiration (EUS-FNA) needles that can provide tissue core biopsies for a true histological~     (rather than cytological) evaluation. By slightly modifying the traditional EUS-FNA needle, a~     new needle named ProCor was developed in the hope of obtaining core samples and thus~     increase diagnostic yield.~      Objective: In this research project, we propose to conduct a prospective trial to compare the~     results obtained with two types of needles: a 25g standard needle (25gS) and the 25g ProCor~     needle (25gP).~      EUS-FNA Biopsies will be obtained with both the 25S and 25P needles in each lesion; a~     randomisation sequence will set in order to determine which of the two needles will first be~     used (25S or 25P).~      The cytological or histological diagnoses will be made; . for histological diagnosis, the~     pathologist will first establish the presence or absence of a tissue core (defined as a~     measurable cylinder of tissue). The pathologist will assess the adequacy of each specimen:~     cellularity (score 1 poor; score 2 good; score 3 excellent),[14] sample bloodiness~     (score 1 minimal;score 2 moderate; score 3 significant, and the presence or absence of~     malignancy(positive / negative / suspicious / inconclusive).~      Results for continuous variables will be summarized using mean ± SD, . and categorical~     variables using proportions. The 25S and 25P groups will be compared using Chi-square test~     for categorical variables and, Student t test for continuous variablesTwo-sided p values less~     than 0.05 will be considered statistically significant. Data will be analyzed using SPSS v~     15.0 (SPSS Inc., Chicago IL) statistical software.~   "
116077|NCT02048111|"~     To evaluate the safety (acute adverse effects associated with infusions, and inhibitor~     development), pharmacokinetics (PK), and efficacy with respect to breakthrough bleeding and~     control of hemorrhaging during prophylaxis of IB1001 in subjects with hemophilia B.~   "
116078|NCT02048098|"~     The purpose of this study is to compare the efficacy of 400 µg vaginal misoprostol per 3~     hours to 400 µg buccal misoprostol per 3 hours in second trimester termination of viable~     pregnancy~   "
116089|NCT02047955|"~     The Tornier Shoulder Outcomes Study is designed to collect safety and efficacy data on~     designated commercially available Tornier Shoulder repair products. In addition, this study~     will provide performance data for use in education, marketing materials, peer-reviewed~     publications and support research and development of future products.~   "
116080|NCT02048072|"~     This study is designed to primarily evaluate the impact of Gilenya (Fingolimod) on the~     autonomic nervous system in patients being treated for the first time with Gilenya~     (Fingolimod). Effects on the cardiovascular system will be studied as well. The study is~     conducted to answer the question, if, and if yes, what impact the treatment with Gilenya~     (Fingolimod) has on the autonomic nervous system. To our knowledge little is known about the~     effects of Gilenya (Fingolimod) on the autonomic nervous system. We do know of rare, but~     potentially clinically and therapeutically relevant cardiovascular adverse events of Gilenya~     (Fingolimod). From a scientific point of view the mechanisms by which this is mediated are of~     interest. Maybe a better understanding of these mechanisms might even be of clinical~     relevance (e.g. risk stratification).~      The impact of Gilenya (Fingolimod) on the autonomic nervous system is quantitavely measured,~     using a state-of-the-art technique. Non-invasive blood pressure measurement is performed with~     the Finometer Pro (Finapres Medical Systems, NL) under different paradigms (breathing at~     rest, deep breath, valsalva maneuver, active standing). In addition the sympathetic skin~     reaction is performed. The non-invasive blood pressure measurements are done by continuous,~     plethysmographic blood pressure measurement at the index finger, while the patient is~     performing the tasks mentioned above. By interpreting the blood pressure curve, heart rate~     and blood pressure variability are calculated. The sympathetic skin reaction consists of~     measuring the change of electric conductibility of the skin (palms and soles) after an~     electric stimulus of a peripheral nerve. These parameters allow to assess the functionality~     of four important autonomic functional systems (orthostasis, sympathetic adrenergic,~     sympathetic cholinergic, parasympathetic cholinergic). Normative data has been acquired in~     our lab.~      Our hypothethis is, that there will be a change of heart rate variability at t4,5h compared~     to baseline (t0) for the parameter RMSSD under normal breathing.~   "
116081|NCT02048059|"~     This is a Phase 2 study to see if an investigational drug, ANG1005, can shrink tumor cells in~     breast cancer patients with recurrent brain metastases.~   "
116082|NCT02048046|"~     Patients with heart and/or lung failure are some of the sickest patients in our hospital~     systems. In severe cases they often need long periods of specialist care in Intensive Care~     Units (ICU) in Australia and New Zealand. Extracorporeal Membrane Oxygenation (ECMO) is an~     extremely specialised and costly form of life support, only being utilised when a patient is~     close to death as a last resort to save their life. This form of life support has been used~     for many years in babies and children but is relatively new for adults. Whilst there is~     evidence emerging of the positive effects of ECMO in adults, there is a lot that is unknown~     and further research is required.~      Another essential therapy that assists patients in their recovery from illness is the~     provision of artificial nutrition. This liquid formula is delivered into the stomach or as a~     nutritionally rich fluid provided into the vein. Until recently nutrition was~     under-emphasised in the critically ill, however, it has now become clear that targeted~     nutrition can positively affect a person's outcome and is vital during long periods of~     intensive care hospitalisation.~      There is very limited data on how nutrition affects the outcomes of ECMO patients (positive~     or negative). We know from limited studies that these patients receive less nutrition than~     other patients, something that is particularly concerning given that less nutrition leads to~     a longer hospital stay and has been linked a with higher hospital mortality. We also think~     that adult patients on ECMO need more nutrition as they appear to lose more weight than~     patients with other illnesses in intensive care; however this has not been confirmed. It is~     thus essential that we understand the effects of this relatively simple but vital therapy on~     these very sick patients.~      This study proposes to collect information on the current feeding practices in patients on~     ECMO and describe the factors that inhibit or allow provision of nutrition so that we can~     understand the issues that exist, develop strategies to improve delivery of nutrition and~     determine areas for further research.~   "
116083|NCT02048033|"~     Prospective multicenters randomized study to compare the efficiency and the socioeconomic~     impact of the endoscopic management (Overstitch technique) of weight regain after gastric~     bypass surgery to non invasive treatment~   "
116084|NCT02048020|"~     This phase II trial studies how well paclitaxel and carboplatin before radiation therapy with~     paclitaxel works in treating human papillomavirus (HPV)-positive patients with stage III-IV~     oropharynx, hypopharynx, or larynx cancer. Drugs used in chemotherapy, such as paclitaxel and~     carboplatin, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Radiation therapy uses high energy x rays to kill~     tumor cells. Giving paclitaxel and carboplatin before radiation therapy with paclitaxel may~     kill more tumor cells.~   "
116085|NCT02048007|"~     The long-term goal of this study is to more precisely define the role of mass azithromycin~     treatments as an intervention for reducing childhood morbidity and increasing growth, and for~     the potential selection of antibiotic resistance. The investigators propose a set of 3~     cluster-randomized trials comparing communities randomized to oral azithromycin with those~     randomized to placebo. To assess the generalizability of the intervention, investigators will~     monitor for antibiotic resistance, which could potentially limit adoption of mass antibiotic~     treatments. The investigators will also assess several measures of infectious diseases. The~     investigators hypothesize that mass azithromycin treatments will reduce childhood morbidity~     and will be accompanied by an acceptable level of antibiotic resistance.~   "
116086|NCT02047994|"~     Currently no ideal preventive modalities are available for reducing gastric-cancer caused~     mortality in organized population-based application. The primary objective of the study is to~     determine if H.pylori screening followed by eradication of positive subjects and endoscopic~     follow-up of those with serological evidence of atrophic gastritis reduces mortality from~     gastric cancer in middle-aged people in high-risk areas. The GISTAR study is a multicenter~     randomized study of H.pylori eradication and pepsinogen testing for prevention of gastric~     cancer mortality. Altogether 30.000 individuals aged 40-64 years will be enrolled, providing~     90% study power to detect at least 35% reduction in gastric cancer mortality at 15 years of~     follow-up. Participants will be randomly allocated to one of two groups. In the active~     investigation/management group those positive for H.pylori will be offered eradication~     therapy and individuals with decreased pepsinogen I/II ratio will be invited for endoscopy.~     The control group will receive standard health care. The primary endpoint for this trial will~     be the mortality difference from gastric cancer between the two groups at 15 years or when~     enough cases accumulate to demonstrate a statistical difference. The study is expected to~     provide valuable information on the utility for reduction in gastric cancer mortality of: 1)~     H.pylori eradication in adults on a population-basis, including subjects who may already have~     pre-malignant lesions; and 2) pepsinogen testing in screening settings. A pilot study of~     3,455 individuals prior to the main trial was conducted from October 2013 to December 2016.~   "
116087|NCT02047981|"~     Our long-term goal is to more precisely define the role of mass azithromycin treatments as an~     intervention for reducing childhood mortality. We propose a single multi-site~     (multi-country), cluster-randomized trial comparing communities randomized to oral~     azithromycin with those randomized to placebo. We hypothesize that mass azithromycin~     treatments will reduce childhood mortality.~   "
116088|NCT02047968|"~     The objective of the study is to examine whether a combination of wake therapy, light therapy~     and sleep time stabilization as a supplement to standard treatment can reduce depressive~     symptoms in patients admitted at two psychiatric wards at Aarhus University Hospital,~     Risskov. Seventy-four patients will be randomized either to this intervention or to a control~     group receiving treatment as usual. Furthermore, it will be examined whether the duration of~     admission can be reduced in the intervention group. Finally, the aim is to identify~     predictors of good effect of the intervention.~   "
116090|NCT02047942|"~     Cardiovascular diseases are the main cause of death worldwide. Aerobic fitness is related to~     long-term survival and a reduction in mortality and recurrent nonfatal myocardial infarction~     in subjects with cardiovascular disease. However, the majority of cardiac patients do not~     engage in enough physical activity to obtain benefits or in the long-term struggle to~     maintain a physically active lifestyle. There is a need for innovative rehabilitation methods~     aiming at increasing longer-term adherence and hence more sustained effects on health related~     physical fitness. One strategy might be the use of home-based training in combination of~     telemonitoring guidance. Therefore, the main objective of this randomized controlled clinical~     trial is to compare the longer-term (=1 year) effects of a 3-month supervised center-based~     rehabilitation program with a patient-tailored home-based cardiac rehabilitation program with~     telemonitoring guidance in CAD patients (phase III). The primary outcome measure is physical~     fitness. It is hypothesized that patients randomized to a home-based training program with~     telemonitoring guidance will demonstrate higher levels of physical activity at one year of~     follow-up, resulting in higher levels of physical fitness, compared to patients who have been~     enrolled to the supervised center-based cardiac rehabilitation program or control group.~     Ninety patients will be randomized to Home-based training, a center-based cardiac~     rehabilitation program or an advice only group (= control group). Assessment will be~     performed at baseline, immediately at completion of the intervention and at one-year of~     follow-up and will include measurements of exercise tolerance, cardiovascular risk factors,~     physical activity, muscle strength, endothelial function, health-related quality.~   "
116091|NCT02047929|"~     Asthma is a common disease that affects people of all ages and has significant morbidity and~     mortality. Poor outcomes and health disparities related to asthma result in part from the~     difficulty of disseminating new evidence and paradigms of care delivery such as shared~     decision making (SDM) into clinical practice. This study will evaluate a novel mechanism for~     dissemination of an evidence-based SDM Toolkit for asthma care in primary care practices. The~     study is ideally suited to study dissemination methods because it will leverage a partnership~     between an established consortium of practice based research networks (PBRNs) and an advanced~     Medicaid Network.~      This study will evaluate a novel dissemination process (FLOW) to spread an Asthma Shared~     Decision Making Toolkit to practices within a Medicaid network using a consortium of~     practice-based research networks (NCNC). The knowledge gained from this proposal and the~     partnerships formed between practice-based research networks and NC Medicaid will facilitate~     widespread dissemination to almost 300 practices.~   "
116092|NCT02047916|"~     The current definitions of neonatal shock/circulatory failure are outdated and inaccurate.~     This makes the development of evidence based protocols for its treatment very difficult.~     Furthermore these definitions often rely on invasive methods of monitoring in patients such~     as an arterial line. Since the advent of functional echocardiography in neonatology there has~     been increased interest in non-invasive measurements of neonatal circulatory failure. However~     research in this field has been confined to premature infants.~      The purpose of the this research is to look at non invasive methods of assessing an infants~     circulatory status in infants older than 33 weeks gestational age in order to fill the~     knowledge gap here and help in the development a new definition of neonatal circulatory~     failure.~   "
116093|NCT02047903|"~     This observational study will investigate the efficacy, safety, tolerability and symptom~     control of GIOTRIF (Afatinib) in daily routine first-line therapy in patients with locally~     advanced or metastatic NSCLC harboring EGFR-mutations. Eligible NSCLC patients, for whom the~     treating physician has decided to initiate treatment with GIOTRIF in first line according to~     the local label, will be followed up for approximately 24 months.~   "
116094|NCT02047890|"~     This is an open-label, non-randomized, dose-escalating Phase I study to evaluate the safety,~     tolerability, pharmacokinetics of BAY1000394 given in a 3 days on / 4 days off schedule in~     Japanese subjects with advanced malignancies.~   "
116095|NCT02047877|"~     The purpose of this study has two major goals: 1) to measure the amount of two specific~     hormones interleukin (IL)-10 and interleukin (IL)-12p70 in mucous and blood; and 2) compare~     the hormone levels in two specific areas of the lung called the trachea (upper airway) and~     the bronchioles (lower airway). The hormones IL-10 and IL-12p70 are cytokines, special~     hormones cells use to communicate with each other during inflammation or infection. Cytokines~     can be measured in mucous and blood. The balance of one cytokine compared to another help~     doctors to understand how people respond differently to infection. Unfortunately, the amount~     of IL-10 and IL-12p70 is not known in children, especially children with a lung infection. In~     addition, we do not know if the balance of these cytokines differ in various regions of the~     lung. We believe the balance of IL-10 and IL-12p70 is similar whether measured in the upper~     or lower airways.~   "
116096|NCT02047864|"~     Osteoporosis is an important health problem, costing the Canadian health care system over $2~     billion per year. Loss of bone mineral and bone fragility is especially prevalent in~     postmenopausal women. Of all osteoporotic fractures, hip fractures are the most traumatic.~     Creatine monohydrate is a nutritional supplement that is often combined with strength~     training to increase strength and muscle mass. The investigators recently completed a pilot~     study in a small number of postmenopausal women (n=33) that showed that creatine monohydrate~     significantly improved hip bone mineral density during a 1-year resistance training program.~     In our current proposal the investigators want to determine whether creatine combined with~     strength training can have an even larger effect on bone mineral density at the hip if given~     over 2 years in a large group of postmenopausal women (n=240). The investigators also want to~     determine whether this leads to reduced fractures in these women for up to a year after~     completing the creatine and strength training program.~   "
116097|NCT02047851|"~     The purpose of this study is to determine whether acupuncture is helpful for patients with~     joint pain associated with psoriasis~   "
116098|NCT02047838|"~     This retrospective case-control study was performed in an Academic centre for the diagnosis~     and treatment of endometriosis. It included patients with recurrent unilateral endometriomas~     who were previously operated for the same condition (cases) and patients without recurrency~     who previously underwent surgery for unilateral endometrioma (controls). The primary outcome~     of the study was to assess the impact on ovarian reserve of second surgery for recurrent~     unilateral endometriomas. The evaluation of ovarian reserve was performed by assessing serum~     anti-mullerian hormone (AMH) level, serum follicle-stimulating hormone (FSH) level, 17-beta~     estradiol level and antral follicle count (AFC).~   "
116100|NCT02047812|"~     Introduction~      'Emergency Laparotomy' is an umbrella term for a set of commonly performed procedures which~     are known to carry a significant risk of mortality and morbidity. Previous work has shown~     considerable inter-hospital variation in emergency laparotomy outcomes within the United~     Kingdom. It is unknown whether there are significant differences in outcomes following~     laparotomy which may be explained by differences in hospital procedural volume.~      Aims~      The aim of this study is to compare emergency laparotomy outcomes in Scotland as they vary by~     hospital procedural volume.~      Methods~      This research study is a retrospective observational enquiry which will utilise~     administrative data from the Information Services Division (ISD) of NHS National Services~     Scotland. Patient episodes will be identified by a set of procedure codes for emergency~     laparotomy.~      The primary outcome measure will be risk-adjusted 30 day/inpatient mortality, and secondary~     outcome measures will be 30 day readmission rate, 30 day re-operation rate and length of~     stay.~   "
116101|NCT02047799|"~     The prevalence and incidence of cardiovascular disease (such as Hypertension) increases~     exponentially with age (McDermott, 2007;) These diseases account for 30% of the global~     mortality (WHO, 2011). Vitamin D (VD) insufficiency affects as many as half of otherwise~     healthy adults in developed countries (Holick, 2007). VD is implicated in the control of~     blood pressure (BP) through inhibition of the renin-angiotensin system (Yamshchikov, 2009),~     although the role of VD supplementation for prevention and treatment of the HTA is~     controversial.The purpose of this study was to investigate if VD supplement in elderly people~     reduces the levels of BP.~   "
116102|NCT02047786|"~     Introduction~      Appendicectomy (or appendectomy in US usage) is the single most commonly performed emergency~     surgical operation performed on British children. Previous investigation of outcomes~     following appendicectomy has suggested that specialist surgeons and high volume centres have~     fewer negative appendicectomies (i.e. the appendix found to be non-diseased), although~     there has not been consistent association found between hospital type or surgeon experience~     and complication rate or admission rate.~      Scotland has 3 dedicated children's surgery centres but straightforward children's surgery~     such as appendicectomy is also carried out in the country's general surgical centres.~     Appendicectomy outcome variations have not been explored in the Scottish National Health~     Service (NHS).~      Aim~      This study will compare appendicectomy outcomes in children between Scotland's specialist~     paediatric centres and general surgical centres.~      Methods~      This is a retrospective study of all appendicectomies performed in Scotland during the period~     from 1st January 2001 - 31st December 2010, on children aged 2 - 12 years old. It will use~     routinely collected administrative data from the Information Services Division of NHS~     National Services Scotland.~      The study will compare risk-adjusted 30 day/in-patient mortality, 30 day re-admission rate,~     30 day re-operation rate, post-operative length of stay and negative appendicectomy rates.~   "
116103|NCT02047773|"~     From the British Thoracic Guidelines1 and a PUBMED search there are no randomised controlled~     trials exploring optimum antibiotic duration for chest infections. The standard course of~     intravenous antibiotics for exacerbations of bronchiectasis is 14 days. This is a preliminary~     open labelled study to assess whether it is feasible to stop treatment earlier (day 8 or day~     11) if the bacterial load is low or absent at days 7 or day 10 (it takes 24 hours for the~     results to be processed). All patients will therefore have a minimum of 7 days intravenous~     antibiotics. The intravenous antibiotic chosen is routinely used for exacerbations in~     bronchiectasis.~      Our hypothesis is that patients could have personalised treatment and be able to stop~     antibiotics when the sputum bacterial load is low (<10^6 colony forming units/ml (cfu/ml)).~   "
116104|NCT02047760|"~     There is increasing evidence that examining our eyes can tell us a lot of information about~     our health, and systemic diseases. We want to study what eyes can reveal about serious~     neurodegenerative diseases like multiple sclerosis, and motor neurone disease, by analysing~     the retinal images from a simple non-invasive eye scan, that is already being routinely used~     to provide immediate clinical information in this group of patients.~   "
116105|NCT02047747|"~     The purpose of this study is to determine the disease response, survival, and side effects of~     an experimental drug called dacomitinib in progressive brain metastases.~   "
116106|NCT02047734|"~     The purpose of this study is to determine whether RPC1063 is effective in the treatment of~     relapsing multiple sclerosis (RMS).~   "
116107|NCT02047721|"~     In this study the Investigators are examining the effects of a 12-week exercise program~     (intervention) on measures of appetite and food intake regulation in overweight to mildly~     obese healthy adults. The Investigators hypothesize that individuals who lose a significant~     amount of weight in response to the intervention will show a reduction in the brain response~     to food cues as measured by functional magnetic resonance imaging (fMRI) when compared to~     those who do not lose weight. These changes in neuronal activity will be associated to~     physiologic and behavioral measures.~   "
116108|NCT02047708|"~     Many patients with scleroderma have damage to their kidneys caused by the disease. There is~     limited evidence for treatments to prevent this damage or stop it progressing. Blocking a~     substance in the blood called endothelin has helped treat some aspects of scleroderma. The~     purpose of this study is to see how effective a new endothelin blocker called Zibotentan is~     in treating patients who have scleroderma and have gone on to develop reduced kidney function~     as a complication. It will be given in addition to the accepted treatments used for~     scleroderma. There will be three parts to this study each for a different group of patients:~        -  ZEBRA 1 for patients with mild or moderate kidney disease caused by scleroderma~        -  ZEBRA 2A for patients with a more severe, acute form of kidney disease caused by~          scleroderma (scleroderma renal crisis) who do not require dialysis~        -  ZEBRA 2B for patients who have had scleroderma renal crisis and are on dialysis~   "
116109|NCT02047695|"~     The purpose of this study is to investigate whether a particular form of migraine, migraine~     with aura, is associated with structural changes in the brain~   "
116122|NCT02047526|"~     This non-interventional, prospective, multi-centric, cross-sectional study is aimed to~     observe clinical practice in India in managing Heart Failure patients & to check one year~     outcome in HF patients. A total of 5 visits will be conducted during the study. There will be~     a baseline visit followed by four follow-up visits to assess the outcomes~   "
116110|NCT02047682|"~     Static postures, repetitive work tasks, and work stress increase the risk for musculoskeletal~     disorders and sickness absence. Objective measurements of occupational loadings - EMG for~     muscular activity, EEG for cognitive activity, ECG for cardiovascular activity and heart rate~     variability, actigraphy for bodily movements - may provide useful early indicators of~     muscular, cognitive and cardiovascular overload.~      The aim of this study is to investigate the effect of an individually tailored~     bio-psycho-social intervention strategy versus usual care ergonomics and standard physical~     exercises (reference group) on these risk factors in lab technicians with a history of~     work-related musculoskeletal pain.~   "
116111|NCT02047669|"~     Musculoskeletal disorders and stress of employees remain a major problem in many occupations.~     The aim of this study is to investigate the effect of an individually tailored~     bio-psycho-social intervention strategy versus usual care ergonomics and standard physical~     exercises (reference group) on musculoskeletal pain, work disability, and stress in lab~     technicians with a history of work-related musculoskeletal pain.~   "
116112|NCT02047656|"~     This study is designed to enable optimal dose selection of LFF269 for potential future~     studies by providing additional information about the compounds safety, tolerability,~     pharmacokinetic and pharmacodynamic profiles.~   "
116113|NCT02047643|"~     Manually suspending an insulin pump at the beginning of aerobic exercise reduces the risk of~     exercise-associated hypoglycemia (low blood sugar) in patients with type 1 diabetes (T1D).~     However, since patients with T1D often do not make exercise-related adjustments to their~     insulin regimen, our group has developed an algorithm to initiate pump suspension in a~     user-independent manner upon projecting exercise-associated hypoglycemia. The current study~     seeks to test the efficacy of this algorithm by asking users to participate in a sports camp~     while wearing an insulin pump, continuous glucose monitor, and accelerometer/heart rate~     monitor (to detect exercise), which will communicate electronically to a pump shutoff~     algorithm. On one of the days the algorithm will be used, while on the other day their normal~     insulin rate will continue for comparative purposes.~      The investigators hypothesize that the use of an accelerometer-augmented computer algorithm~     for insulin pump suspension during exercise will result in significantly fewer episodes of~     hypoglycemia (both during exercise and in post-exercise monitoring) than in exercise without~     a pump suspension algorithm.~   "
116114|NCT02047630|"~     The purpose of this study is to evaluate and compare efficacy and tolerability of the~     brand-name latanoprost and one of its generic version in subjects with primary open angle~     glaucoma or ocular hypertension.~      This randomized, double-blinded, cross-over design study has a 4 months follow-up. There are~     two periods of 8 weeks. During the first period, subjects put brand-name latanoprost in one~     eye and the generic version in the other one. In the second period, drops are switched from~     one eye to the other. There are intraocular pressure measurements (diurnal curves) on day 0~     (before treatment), at 8 weeks (at the end of first period) and at 16 weeks (at the end of~     second period). Variations of intraocular pressure in each eye will be evaluated.~   "
116115|NCT02047617|"~     Critically ill patients frequently develop muscle weakness due to critical illness-related~     acute neuropathy and/or myopathy. This disorder is associated with difficulties in weaning~     from mechanical ventilation, prolonged intensive care unit and hospital stay, and increased~     mortality rates. In addition, many patients continue to suffer from decreased exercise~     capacity and quality of life for months to years after the acute event.~      Besides controlling risk factors, no specific prevention or treatment exists. Recommendations~     advice to start early with active and passive exercise in critically ill patients (1). Having~     critically ill patients alert and engaged in progressive rehabilitation leading to~     mobilization, despite the use of life support therapies may reduce muscle atrophy and lead to~     improved strength and physical function (2).~      This randomized controlled trial was designed to investigate whether a daily training session~     using a tilt table, started early in stable critically ill patients with an expected~     prolonged ICU stay, could induce a beneficial effect on exercise performance, quadriceps~     force and functional autonomy at ICU and hospital discharge compared to a standard~     physiotherapy program.~   "
116116|NCT02047604|"~     A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of~     Escalating Doses of SAN-300 in Patients with Active Rheumatoid Arthritis with Inadequate~     Response to Disease-Modifying Anti-rheumatic Drug(s).~   "
116117|NCT02047591|"~     The 3rd governmental plan of fighting against the pain favored the development and the~     evaluation of the efficiency of the non pharmacological methods. Its results always showes a~     lack of knowledge of these methods and the utility to pursue the researches.~      In the department of pediatric surgery of the university hospital of Limoges, the~     relaxing-touch is one of these methods which is more and more used. The healthcare staff~     noticed the beneficial effects of such an empirical method in terms of comfort and quality of~     life for the children.~      In 2011, a pilot study led in this department showed that, in spite of the usual treatment,~     the removal of the Redon's drain remains painful for 25 % of the children (score on the pain~     scale > or = 4). This result convinced the medical team to write a protocol of research from~     the following hypothesis: the implementation of a protocol of the Redon's drain removal~     associated to the relaxing touch and usual treatment could lead to a decrease of the acute~     pain for a 7 to 17 years old child.~   "
116118|NCT02047578|"~     To evaluate the outcome of hematopoietic stem cell transplantation using targeted busulfan,~     fludarabine, etoposide conditioning regimen in childhood and adolescent ALL.~   "
116119|NCT02047565|"~     This Phase 1 study consists of 2 parts. Part 1 will be an open-label, randomized, 2~     treatment, 2-way crossover study. Part 2 will be a double-blind (Sponsor unblinded),~     randomized, placebo controlled, sequential descending prothrombin complex concentrate dose, 2~     sequence, 2 period crossover study. In both parts of the study, the assessor of BD and BV~     will remain blinded. In Part 2 of the study, both the subject and the clinic staff involved~     in study conduct will be blinded (with the exception of the pharmacist or nurse who prepares~     the blinded individual treatments from open-label supplies). The study programmer and~     statistician will also be blinded to treatment assignment. The Sponsor will remain unblinded~     for both parts of the study.~   "
116120|NCT02047552|"~     The purpose of this trial is to determine if the combination of goal directed iron~     supplementation and hepcidin mitigation can safely eliminate both the serum and bone marrow~     iron debt of anemic, critically ill trauma patients with functional iron deficiency.~   "
116125|NCT02047487|"~     This is a randomized, open controlled multicenter phase II clinical study. The SPSS~     statistical software estimation of sample size, selection of the initial treatment of locally~     advanced head and neck squamous cell carcinoma in 120 patients, such as to achieve the~     desired results, considering expanding the clinical, according to the proportion of 1:1 were~     randomly divided into two groups, all patients were taken, docetaxel + cisplatin 2 cycles of~     induction chemotherapy 、Concurrent chemoradiotherapy（tomotherapy+cisplatin）, The experimental~     group was added with AVASTIN.~   "
116126|NCT02047474|"~     This phase II trial studies how well combination chemotherapy before and after surgery works~     in treating patients with localized pancreatic cancer. Drugs used in chemotherapy, such as~     leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving combination chemotherapy before surgery may make the tumor smaller~     and reduce the amount of normal tissue that needs to be removed. Giving these treatments~     after surgery may kill any tumor cells that remain after surgery.~   "
116127|NCT02047461|"~     This study will include a screening period, a 6-month treatment period, and a 60-month,~     long-term extension period.~   "
116128|NCT02047448|"~     The purpose of this pilot study is to determine if medication adherence is improved by a~     transitional care pharmacy practice model designed to integrate hospital and community~     pharmacists in the care and education of patients with heart failure or COPD who are~     discharged from a community hospital to home. The hospital and community pharmacists will~     collaborate with each other, the patient, and other practitioners including the primary care~     physician, nurse, and case manager to prevent and correct medication-related problems and~     attempt to improve patient outcomes especially during the error-prone transition from~     hospital to home.~   "
116129|NCT02047435|"~     Social relationships are important to people and it affects their quality of life, morbidity~     and mortality.~      This is a randomised controlled trial studying the effect of including older people with~     impaired social relationships and a perception of loneliness at workshops, at The Storm P.~     Museum - a museum about the well known Danish cartoonist Robert Storm Petersen.~      The hypothesis is, that by including older lonely people with a impaired social participation~     in these workshops, they will increase the participants health related quality of life. The~     investigators also hypothesis, that the intervention will improve the participants perception~     of loneliness, social participation and physical function.~      The intervention consist of a series of workshops at the Storm P. Museum. At these workshops~     the participants will create memory material for nursing home residents with dementia. The~     museum staff will facilitate a process of storytelling, using events, significant stories and~     artistic works by Storm P. and encourage the participants, by means of the narrative~     interview method to share similar stories from their life.~   "
116130|NCT02047422|"~     To compare the effectiveness and safety of diuretics add-on strategy in chronic heart failure~     patients~   "
116131|NCT02047409|"~     The purpose of this study is to determine whether oscillatory pattern of sympathetic nerve~     activity muscle is an efficient index for the prognosis of patients with heart failure.~   "
116132|NCT02047396|"~     To comprehensively characterize Left Ventricular (LV) remodeling after Myocardial Infarction~     (MI) in the community, study the association between patterns of remodeling and biological~     pathways and examine the association between the predictors of remodeling and heart failure~     after Myocardial Infarction.~   "
116133|NCT02047383|"~     The acute respiratory infection is the fourth most common cause of hospital stay between~     elderly people. The purpose of this study is to evaluate the repercussion of hospital stay in~     hospitalized patients with a respiratory infection.~   "
116134|NCT02047370|"~     Physical therapists have traditionally included various forms of manual therapy among the~     therapeutic approaches to respiratory conditions. The aim of this study was to evaluate the~     effect of diaphragmatic stretching technique on pulmonary ventilation, rig bage excursion and~     spirometric values in patients diagnosed with asthma.~   "
116135|NCT02047357|"~     To test the efficacy of an innovative affordable intervention program that can be used by~     non-specialists, including mothers and lady health workers with minimal training in low~     resource countries such as Pakistan~   "
116136|NCT02047344|"~     This is a single arm, open label, Phase II study in KRAS-positive and KRAS-negative patients~     with stage IV (including pleural effusion) non squamous NSCLC who have failed two lines of~     anti-cancer therapy. A maximum of 60 evaluable patients with NSCLC will receive~     antroquinonol, of which 30 patients will be KRAS-positive and 30 patients KRAS-negative. An~     evaluable patient will have received at least one dose of antroquinonol and have a valid~     baseline tumor assessment. Enrollment will continue until the target number of evaluable~     patients has been enrolled.~   "
116137|NCT02047331|"~     In this study, the aim is to compare the efficacy of Periarticular multimodal drug~     injection(group PI) and Fascia Iliaca Compartment Block ( group FI)for total knee~     arthroplasty.~   "
116138|NCT02047318|"~     The purpose of this extension study is to determine the long-term safety and tolerability of~     an investigational treatment (LUM001) in children with ALGS who have completed participation~     in the LUM001-302 study.~   "
116139|NCT02047305|"~     Patients with MGIN, HGIN or flat-type early SCCA of the esophagus will be treated on 3 month~     intervals with Radiofrequency Ablation (RFA) until complete eradication (CR: no MGIN or worse~     in the biopsies) will be achieved. All patients will undergo an endoscopy at 12 months after~     baseline, and the patients with CR will undergo annual endoscopy with biopsies for 5 years.~   "
116165|NCT02046967|"~     Endovenous laser ablation is a common therapy of great saphenous vein insufficiency with a~     very high success rate. It works by heating and thereby obliterating the vein. Steam ablation~     is a new therapy that also works by heating and thereby obliterating the vein. The hypothesis~     of this study is that steam ablation is as effective as laser ablation, but that it results~     in better secondary outcomes (e.g., lower pain scores).~   "
116598|NCT02041312|"~     Investigators have a plan to conduct nested case-control study to investigate the association~     between serum cholesterol levels including TC, HDL-C, LDL-C, triglyceride (TG),~     apolipoproteins and gastric neoplasm. In addition, further analyses were performed to~     evaluate the possible role of the serum cholesterol as a predictor for the differentiation~     and prognosis of gastric neoplasm.~   "
116140|NCT02047292|"~     Pain and reduced function are the most common symptoms of coxarthritis. Pain relief and~     normal range of motion (ROM) restoration are the objectives of a Total Hip Arthroplasty (THA)~     procedure. It is recognized that increased head-neck ratio results in increased ROM due to~     the fact that prosthetic impingement between neck and acetabular liner occurs with wider arcs~     of motion. This head-neck ratio has been investigated extensively only in vitro (on cadavers~     or sawbones) or using mathematical modeling in computer simulations. These studies are~     limited by the lack of soft tissues and muscle activations in the models. This study will~     clinically assess the effect of prosthetic head diameter on patient capability of performing~     movements which require extreme arcs of motion of the hip joint. Therefore, the research~     questions are:~        -  What role do soft tissues play in limiting ROM?~        -  Can prosthetic impingement really occur in a well positioned THA?~        -  Can a bigger head diameter alone reduce the risk of impingement?~   "
116141|NCT02047279|"~     The purpose of this study is to estimate left atrial volume reduction surgery concomitant~     with the maze procedure and mitral valve repair/replacement in patients with atrial~     fibrillation with an enlarged left atria.~   "
116142|NCT02047266|"~     The purpose of this study is to compare three different revascularization strategies in~     patients with multi-vessel coronary disease: MICS CABG, OPCABG and ONCABG.~      The study hypothesis: MICS CABG (Minimally invasive cardiac surgery coronary artery bypass~     grafting) has advantages in comparison with conventional off-pump (OPCABG) and on-pump~     coronary artery bypass grafting (ONCABG) concerning major adverse cardiac and cerebral events~     (MACCE) and procedural success.~   "
116143|NCT02047253|"~     This study will test how effective the drug, Carfilzomib, reduces progression of prostate~     cancer in patients who have previously received chemotherapy and androgen inhibitors.~     Carfilzomib is approved for multiple myeloma but is not approved for prostate cancer.~     Therefore, it is considered investigational. Other approved methods of treatment for~     metastatic prostate cancer have demonstrated only modest benefits. Novel and tolerable agents~     are necessary to make further gains and extend overall survival.~   "
116144|NCT02047240|"~     We have several ways to appropriately determine renal function in healthy patients and in~     several diseases, in cirrhotic population we dont have a precise tool that has sufficient~     precision that reflects glomerular function, although it has been reported that cystatin C,~     because of its nature could improve diagnostic accuracy to determinate the renal function in~     this population.~      The investigators hypothesize that glomerular filtration obtained from cystatin-C-derived~     formulas are more accurate when compared to creatinine-derived formulas with DTPA-Tc99~     (diethylene-triamine-pentaacetate- technetium-99) as gold standard.~   "
116145|NCT02047227|"~     This is a Phase 3, randomized, controlled, single-blind, multicenter, parallel-arm trial to~     assess the safety and efficacy of Pergoveris® (recombinant human follicle stimulating hormone~     [r-hFSH]/recombinant human luteinising hormone [r-hLH]) and GONAL-f® for multifollicular~     development as part of an assisted reproductive technology (ART) treatment cycle in poor~     ovarian responders, as aligned with the 2011 Consensus Meeting of the European Society of~     Human Reproduction and Embryology (ESHRE) criteria.~   "
116146|NCT02047214|"~     The purpose of this study is to evaluate the safety, maximum tolerated dose (MTD), and~     efficacy of TPI 287 in combination with Avastin (bevacizumab) in subjects who have~     glioblastoma multiforme (GBM) that has progressed following prior radiation and temozolomide~     (TMZ) therapy and that has progressed following prior bevacizumab therapy.~   "
116147|NCT02047201|"~     To evaluate the safety and efficacy of cisplatin plus intensity-modulated radiotherapy (IMRT)~     based on FDG-PET/CT after induction chemotherapy (IC) for locally advanced head and neck~     squamous cell carcinoma.~   "
116148|NCT02047188|"~     Combined with magnifying endoscopy,narrow-band imaging (NBI) contrasts microvascular~     architecture on lesion surface.The histology of early colorectal lesions could be predicted~     under NBI view.However,its capability for estimating invasion depth remains to be~     verified.The study is based on the hypothesis:NBI can predict histology and invasion~     depth,combined with the verification of microvessel count and MMP-7 expression.~   "
116149|NCT02047175|"~     The purpose of this study is to evaluate the drug-drug interaction of~     CKD-346(Telmisartan/S-Amlodipine, Rosuvastatin)~   "
116150|NCT02047162|"~     The purpose of this study is to learn whether bismuth subsalicylate can reduce use of~     antibiotics among adults with diarrhea in Pakistan.~   "
116151|NCT02047149|"~     Prospective nonrandomized phase I study~      The purpose of this study is to determine safety and efficacy of zileuton when added to~     dasatinib in patients with chronic myelogenous leukemia (CML).~   "
116152|NCT02047136|"~     Histamine is a biologically active component that can be found in many foods and beverages.~     Intake of excessive histamine from foods or beverages, can trigger symptoms including~     urticaria. A low histamine diet has been recommended as one of the possible treatments for~     patients with chronic urticaria. There are very few studies to confirm the effectiveness of~     such diets and, to the investigators' knowledge, none from Asia where high histamine~     containing meals are often eaten (personal observations). The objective of the present study~     is to investigate the therapeutic effect of low histamine diet in relieving symptoms in~     patients with chronic urticaria with or without angioedema, and / or pruritus (U/A/P). The~     investigators hypothesize that following a low histamine diet for 4 weeks, the symptoms of~     patients with chronic U/A/P should improve.~   "
116214|NCT02046330|"~     We propose a clinical study of medial forebrain bundle DBS as a treatment in 10 patients with~     treatment refractory depression (TRD). Data from the University of Bonn indicates that~     surgical lesions of the medical forebrain bundle can produce therapeutic benefits in patients~     with depressive disorders, and suggest that DBS at the same site may also reduce~     symptomatology in these TRD patients (Schaepfer, 2013). Depression affects up to 10% of the~     US population and of those at least 10-15% do not benefit from therapies hence why we must~     explore new treatments. The Activa® systems manufactured by Medtronic Neurological will be~     used in this study. Study subjects will be between the ages of 22 and 65 years of age and~     suffer from TRD, have failed multiple treatment regimens, including ECT, and remain~     symptomatic. Those identified as TRD patients will then be enrolled in a clinical pilot study~     investigating DBS, targeting the MFB.~   "
126724|NCT01908751|"~     The purpose of this study is to determine the impact of surgical fixation (cancellous screws~     versus sliding hip screws) and biologic intervention (Vitamin D versus placebo) on patient~     important outcomes.~   "
116153|NCT02047123|"~     Flax (Linum usitatissimum L.) is an economically important oilseed. Lifestyle and diet are~     the first line interventions to reduce the short-term and long-term cardiovascular risk~     factors. Due to its high content of lignans, α-linolenic acid (LNA) and fiber, flaxseed has a~     beneficial effect on CVD risk factors, components to decrease the risk of cardiovascular~     disease. Objective: To determine the effect of the consumption of flax seed yogurt on the~     women lipid profile values to the limit, users of a pharmacy in Elche and in this way reduce~     the small dyslipidemia. The investigators performed an intervention including 133 women (age=~     25-70 years). Participants were randomly and double-blind distributed into three groups:~     Group 1 (n= 30) consumed flaxseed (FS), yoghurt (Y) and diet (D), Group 2 (n= 32) volunteers~     consumed (Y) + (D) and Group 3 (n=27) consumed only diet. All groups followed a limit~     levels-cholesterol diet. Circulating total cholesterol, HDL-cholesterol, LDL-cholesterol and~     triglycerides and were determined at the beginning and end of a 30-day test. As a result,~     group 1 presented significantly reduced total cholesterol levels. Correlation analysis~     indicated that the intake of (FS) could explain the flaxseed effect of the variation of the~     cholesterol and TG in this group. Altogether, this study concludes that consumption FS exert~     a positive impact in total cholesterol level and TG~   "
116154|NCT02047110|"~     The overall purpose of the trial is to assess the clinical efficacy of three different~     subcutaneous doses of BI 655066 in adult patients with AS, in order to provide clinical proof~     of concept and to select dose (s) for confirmatory clinical trials.~   "
116155|NCT02047097|"~     The primary objective of the study is to determine the incidence, type, and pattern of~     serious adverse events (SAEs), including but not limited to infections (including~     opportunistic infections), hepatic events, malignancies, and renal events, and of adverse~     events (AEs) leading to treatment discontinuation in patients with MS treated with dimethyl~     fumarate (DMF). Secondary objectives of this study in this population are as follows: To~     determine dimethyl fumarate (DMF) prescription and utilization patterns in routine clinical~     practice in patients with multiple sclerosis (MS); To assess the effectiveness of dimethyl~     fumarate (DMF) on multiple sclerosis (MS) disease activity and disability progression in~     routine clinical practice as determined by the Expanded Disability Status Scale (EDSS) score~     and multiple sclerosis (MS) relapse information; and To assess the effect of dimethyl~     fumarate (DMF) on health-related quality of life, healthcare resource consumption, and work~     productivity.~   "
116156|NCT02047084|"~     Given the propensity for venous leg ulcers to become refractory, long standing lesions,~     incorporating active biologic grafts into the standard compression therapy, has shown to~     accelerate wound healing.~      The two products to be compared in this study are both commonly used for the treatment of~     venous leg ulcers. Apligraf is considered a medical device by the FDA, and was cleared for~     the treatment of venous leg ulcers in 1998. It is a staple for the treatment of venous leg~     ulcers, and is widely used throughout the United States. It is composed of a type 1 collagen~     matrix in which human foreskin-derived neonatal fibroblasts are grown, and over which human~     foreskin-derived neonatal keratinocytes are then cultured and allowed to stratify.~      TheraSkin is composed of a split thickness skin graft harvested within 24 hours post-mortem,~     from an organ donor who has cleared the standard safety screenings. It is classified by the~     FDA as a donated tissue. Once harvested, the graft is sanitized according to FDA~     specifications, and cryopreserved, until it is delivered to the clinic for application to the~     foot ulcer. It is also a widely used treatment for diabetic foot ulcers.~      TREATMENT RATIONALE FOR THIS STUDY Chronic wounds of the lower extremities affect a~     substantial proportion of the population. Venous leg ulcers (VLU) account for 40-70% of lower~     extremity wounds. The standard of care for treatment of VLU's in wound centers in the United~     States is compression therapy combined with application of biologic graft materials to the~     wound bed.~      This study may assist physicians who treat VLU's by comparing efficacy and costs of two~     commonly used biologic graft materials for VLU's in a randomized prospective study. In~     addition to standard compression therapy, this investigation will be a head-to-head study~     comparing widely used bio-engineered skin substitute (Apligraf) to cryopreserved, human skin~     allograft (Theraskin). There is no randomized, prospective data comparing these two graft~     options in the treatment of VLU's.~   "
116157|NCT02047071|"~     The purpose of this study is to determine whether Continuous Positive Airways Pressure (CPAP)~     improves quality of life, cardiovascular (blood pressure) and metabolic profile (glucose and~     lipid metabolism) in females with moderate-to-severe Obstructive Sleep Apnea (OSA).~   "
116158|NCT02047058|"~     The purpose of this study is to determine whether Q cells separated from the glioma sample~     are determinants in treatment response and prognosis of glioma patients~   "
116159|NCT02047045|"~     This trial is primarily aimed to compare the effect and safety of electro-acupuncture and~     prucalopride for severe chronic constipation: if the short-term effect of electro-acupuncture~     is no inferior to prucalopride? Besides, the investigators will also mainly confirm the~     superiority of electro-acupuncture: if the effect of electro-acupuncture can last for 3~6~     months? Then, assess the patients' acceptance of electro-acupuncture.~   "
116160|NCT02047032|"~     A noninferiority randomized controlled trial aimed at comparing the effect and safety of~     electroacupuncture versus the pelvic floor muscle training (PFMT) plus solifenacin for mixed~     urinary incontinence (MUI).~   "
116161|NCT02047019|"~     This study examines the efficacy and safety of the Fixed Dose combination BAY98-7106~     (nifedipine plus candesartan) in patients with hypertension, who do not achieve adequate~     control of blood pressure with candesartane alone.~      Patients meeting the entry criteria, will receive candesartan alone 16mg in the first five~     weeks of the study to assess blood pressure control with candesartan given alone.~      Patients with an insufficient therapeutic response to candesartan alone (defined by mean~     seated systolic blood pressure >/=140 mm/Hg) will enter the next part of the study, and will~     be randomly assigned to one of 3 treatments ( candesartan alone 16mg, combination nifedipine~     / candesartan 30/16 mg, combination nifedipine / candesartan 60/16 mg). Neither patient nor~     the treating physician will know which treatment is given (double-blinded design).This part~     of the study will last eight weeks.~   "
116162|NCT02047006|"~     Rivaroxaban is a recently developed factor Xa (FXa) inhibitor for the prevention and~     treatment of thromboembolic disease. There are no data on dose adjustments in patients with~     severe chronic renal failure. It's use is therefore not recommended in this patient~     population. The present study aims to asses in 12 hemodialysis patients that require~     prevention of deep vein thrombosis:~        1. the AUC and Cmax of 10 mg rivaroxaban~        2. the effect of 10 mg rivaroxaban on coagulation assays~        3. the effect of a single dialysis session on plasma levels of rivaroxaban and on anti-Xa~          levels~        4. the safety and tolerability of rivaroxaban~   "
116163|NCT02046993|"~     To test the hypothesis that hypertensive patients who participate in smart phone based~     telemonitoring of BP will conduct more home blood pressure monitoring, better self management~     behavior and greater reduction in blood pressure and better self management behaviour from~     baseline to 6 months follow up than those patients receiving enhanced usual care.~   "
116166|NCT02046954|"~     Compromised tissue oxygenation during surgery may negatively influence patient outcome.~     Primary cause of insufficient tissue oxygenation is reduced cardiac output due to hypovolemia~     and/or reduced cardiac contractility. In cardiac surgery patients especially, postoperative~     pericardia effusion and/or tamponade may further compromise cardiac function. Today,~     hemodynamically instable patients are often monitored by means of pulmonal artery catheters~     or transpulmonary thermodilution. However, these methods only allow quantification of~     functional limitations. Underlying causes may be investigated by relatively recent technology~     through hemodynamically focussed transesophageal echocardiography (ClariTEE(R) ImaCor) that~     also provide the possibility of continuous monitoring. It has been reported that a training~     program consisting of six hours may enable physicians who are unexperienced in the field of~     echocardiography to apply this new method. Up to now, there is no evidence whether this~     methods is associated with improved postoperative outcome.~      Therefore we hypothesize that continuous hemodynamically focussed transesophageal~     echocardiography positively influences patient outcome (primary hypothesis). Furthermore, its~     application may decrease hospital expenses (secondary hypothesis).~   "
116167|NCT02046941|"~     The study will use MRI brain imaging to identify brain changes associated in stroke patients~     after they receive speech-language treatment for their speech difficulties.~   "
116168|NCT02046928|"~     This study will assess the efficacy, safety and pharmacodynamic markers of the study drug,~     A6, in patients with CLL and small lymphocytic lymphoma (SLL).~   "
116169|NCT02046915|"~     Highest treatment efficacy in patients with refractory myeloma may be achieved with regimens~     combining novel agents and alkylating agents. However, in applying this approach the patients~     are at substantial risks of a critical myelosuppression. Pomalidomide demonstrates~     significant activity in combination with Dexamethasone in relapsed or refractory multiple~     myeloma. This trial is an attempt to further improve the efficacy of~     Pomalidomide/Dexamethasone as well as to balance efficacy and toxicity. Integration of~     Cyclophosphamide in the treatment in case of suboptimal response or first evidence of~     progressive disease has the aim to significantly increase duration of treatment that should~     have a positive impact on PFS. It is furthermore an attempt to optimize the potential of~     Pomalidomide in the antimyeloma efficacy. Based on the recent findings, that myeloma is a~     disease with a wide clonal heterogeneity, combination treatment in case of suboptimal myeloma~     control might lead to a more effective suppression especially of aggressive subclones and~     might reduce early resistance. In addition, with the goal of keeping the individual patient~     as long as possible under an effective IMiD treatment, the potential of the drug might be~     optimized according to the current view of maintenance treatment resulting ideally in an~     outgrowth of indolent clones in the bone marrow niche.~   "
116170|NCT02046902|"~     The goal of this study is to gather input from patients who have undergone PCI, their family~     and/or caregivers, and clinicians to develop a patient decision aid. The purpose of the~     decision aid is to deliver information, including individualized estimates of patients'~     restenosis risk, in an understandable format that would be informative and assist in~     decision-making for patients undergoing PCI.~   "
116171|NCT02046889|"~     The objectives of this study are to 1) demonstrate the effectiveness of the innovative~     bicycle training program in teaching youth with DS and ASD how to ride a standard two wheel~     bike, and 2) determine the effects of the treatment on health related performance measures,~     physical activity level, patterns of sleep behavior, psychosocial outcomes, and community~     participation. The hypotheses to be tested in this study are: 1) there will be a significant~     treatment group difference (EXP vs CON) in the number of participants who demonstrate the~     ability to ride a two wheel bicycle in favor of the EXP group following the first year of~     training. 2) At the end of the second year of training when the CON group receives the~     bicycle training program, there will not be a group difference in the number of riders who~     learned to ride. 3) At the end of the first year, there will be a significant treatment group~     difference (EXP vs CON) on the health related performance measures, average time spent in~     moderate and moderate to vigorous physical activity, patterns of sleep behavior (sleep onset,~     frequency of night waking), self and parent perceptions of bicycle riding ability, and~     community participation (number of community activities engaged in, frequency of community~     participation, number of people they participate with outside of the parents, the number of~     community locations in which they participate), in favor of the EXP group. 4) At the end of~     the second and third year, the CON group will demonstrate a significant improvement in all of~     these measures (a significant improvement from the pre-training measures to the 12 and 24~     month measures). 5) At the end of the third year, the EXP group will demonstrate a~     significant group difference on all measures compared to the CON group but the magnitude of~     the difference will be less than was observed in hypothesis 3 at the 12 month measurement~     before the CON group received their training. These hypotheses will be tested separately for~     the DS and ASD groups.~   "
116172|NCT02046876|"~     Chronic neck pain (CNP) is defined as pain or intense discomfort in the lateral or back of~     the neck with an establishment and/or persistence period of over 12 weeks.~      The socio-economic system is seriously affected by chronic neck pain due to direct and~     indirect costs on the health system Physical exercise is used to improve physical function~     and reduce the symptoms of pain and stiffness due to chronic neck pain.~      It has been demonstrated that therapeutic exercise in water is effective to improve~     functional capacity and symptoms in patients with chronic neck pain. In adition, health~     education and posture is an important component of the overall treatment of neck pain.~      Interventions that integrate physical activity, adapted swimming and health education as an~     intervention for chronic neck pain sufferers have not been found. Furthermore the aim of this~     study is to analyse the effect of a physiothperapy treatment that combine adapted swimming,~     therapeutic exercise and health education in patients with chronic neck pain.~      Hypothesis: the present intervention will be an effective tool to treat patients suffering~     chronic neck pain.~      Methods: chronic neck pain patients from a community-based centre will be recruite~     participate in this prospective study.~      Intervention: 60 min session: 30 min of land exercise dedicated to improve mobility, motor~     control, resistance and strengthening of the neck muscles, 30 min of adapted swimming with~     aerobic exercise keeping neutral neck position by using a snorkel. Health education will be~     provided by the physiotherapist before and during the sessions using a decalogue on chronic~     neck pain and constant repetition of brief advice.~      Study outcomes: disability (Neck Disability Index), physical and mental health state and~     quality of life of patients (SF-12 and EuroQoL 5D respectively).~      Differences between baseline data and that at the 8-week follow-up were calculated for all~     outcome variables.~      Statistical Analysis: descriptive statistics. Analysis of the normal distribution of the~     variables using the KS-test. Comparison of variables pre - post intervencición: T-Student for~     parametric variables and Wilcoxon test for non parametric variables.~      Data will be analysed descriptively and for statistical significance using Statistical~     Package for the Social Sciences (SPSS) (version 17.0 for Windows, Illinois, USA).~   "
116173|NCT02046863|"~     The clinical utility of deep brain stimulation (DBS) for the treatment of movement disorders~     such as Parkinson's disease has been well established; however, there is a great disparity in~     outcomes among DBS recipients due to varied postoperative management, particularly concerning~     the choosing of an optimal set of programming parameters from the thousands of possible~     combinations. This study will evaluate the use of motion sensor based assessments to develop~     a functional map and algorithms to automatically determine a set of programming parameters~     that maximize symptomatic benefits while minimizing side effects and battery consumption.~   "
116174|NCT02046850|"~     Study to assess the effect of Rifampicin on the pharmacokinetics of Selumetinib (AZD6244;~     ARRY-142886) (Hyd-Sulfate) in Healthy Male Volunteers~   "
116599|NCT02041299|"~     This research is being done so that we can look at the safety and efficacy of deferiprone in~     people with sickle cell disease or other anemias. Deferiprone is a drug that removes iron~     from the body. We will be comparing deferiprone with deferoxamine, another drug that removes~     iron from the body.~   "
116175|NCT02046837|"~     Prostate Cancer (PC) affects 1 in 7 men. Nearly half of those diagnosed with PC will receive~     androgen deprivation therapy (ADT) as part of their treatment. ADT is good at managing PC but~     has many side effects. Researchers have shown that exercise, specifically one-on-one~     supervised exercise improves many of the side effects of ADT. However, exercise programs for~     men on ADT are not widely available. More questions need to be answered in order for exercise~     programs to become part of PC treatment. First, can programs that require fewer resources,~     such as group-exercise or home-based exercise, also improve ADT side-effects? Second, do~     exercise-related benefits continue beyond the structured exercise program? And what makes~     people continue exercising? Third, which exercise program is most cost-effective?~      In this study, the investigators will compare: (a) group supervised in-centre; (b) home-based~     supported; and (c) 1:1 supervised in-centre exercise programs to see which program is most~     effective for men with PC on ADT. The investigators will also look at what motivates people~     to continue to exercise both during a structured program and after the program is complete~     and will examine which exercise program is most cost-effective.~      The investigators will ask men with PC on ADT that are being treated at either Princess~     Margaret Cancer Centre in Toronto or the Tom Baker Cancer Centre in Calgary to participate in~     the study. When a patient agrees to participate, he will be randomly placed in 1 of the 3~     exercise programs. All programs will include the same type of exercises (aerobic, resistance~     and flexibility) and all participants will exercise 4-5 days per week for 30 minutes per day~     (as tolerated) for the length of the program (6 months). The investigators will look at how~     men with PC on ADT respond to the exercise program by measuring quality of life (QOL),~     fatigue and different physical measures before, during, and after the exercise program.~      Although the investigators know that supervised one-on-one exercise is most effective at~     improving ADT side-effects, it is unknown if other forms of exercise are just as beneficial~     and more financially responsible. This study will allow the investigators to begin to answer~     these questions so that structured exercise programs become a regular part of PC treatment.~   "
116176|NCT02046824|"~     Cell savers are routinely used in our hospital during off-pump coronary artery bypass~     grafting to retrieve and wash blood that is lost during the operation. This washed blood is~     retransfused to the patient in order to prevent allogeneic blood transfusion. However, little~     is known about the rheologic properties and oxygen transport capacity of the washed red blood~     cells and the effects of retransfusion of this blood on microcirculatory blood flow and organ~     damage in the patient. For cell savers 3 different operating principles exist. The most~     common one uses discontinuous blood washing with a spinning bowl that is intermittently~     filled with blood, processed and emptied. A second one uses a continuous blood washing~     principle with a rotational disk. A third one is intermediate using features of both the~     discontinuous bowl technology and the continuous rotational disc technology.~      The investigator hypothesize that the operating principle has effects on the rheologic~     properties and oxygen transport capacity of the washed blood.~      Previous research suggested that in particular the deformability and oxygen carrier~     properties of the red blood cells are affected. As a consequence, red blood cells may block~     small blood vessels, which affects microcirculatory blood flow and tissue oxygenation. This~     may lead to organ damage.~   "
116177|NCT02046811|"~     The objective of this study is to determine the impact of a 12-month patient activation and~     education intervention on skin cancer early detection practices among childhood cancer~     survivors treated with radiation. This randomized controlled trial uses a three-group design.~      Our specific aims are to: (1) Determine the impact of a Patient Activation and Education~     intervention with and without physician activation and teledermatology on skin cancer early~     detection practices, (2) Determine the impact of the intervention on time to diagnosis, and~     (3) Estimate the cost and cost-effectiveness of the intervention as a secondary outcome.~   "
116178|NCT02046798|"~     This study measures how much of the trial drug enters the body and how long it takes for the~     body to remove it via the feces and urine. In addition, the different breakdown products~     after a single oral dose of radio-active ASP3652 will be identified.~   "
116179|NCT02046785|"~     The purpose of this study is to determine whether hemodynamic measures vary in angles bedside~     before and after volume challenge.~   "
116180|NCT02046772|"~     A single blind, randomized, with blinded evaluation by third parties clinical trial is~     carried out to assess the analgesic efficay of the addition of morphine chloride to a low~     dose solution of spinal local anaesthetic compared to a standard dose spinal anaesthetic in~     the haemorrhoid surgery.~      The objective of this clinical trial is to assess if the experimental treatment is as~     efficacy as the standard treatment in the anesthetic and analgesic effects with less side~     effects, greater and earlier mobility after surgery and shortened the hospitalization.~   "
116181|NCT02046759|"~     The aim of the study is to compare the effect of asthma care by clinical pharmacist~     intervention versus routine care on asthma control.~   "
116182|NCT02046746|"~     The study objective is to evaluate if a renal specific oral nutrition supplement (ONS) aids~     in maintaining nutritional status.~   "
116183|NCT02046733|"~     Despite the fact that the majority of the patients with limited disease SCLC will respond~     very well to the standard treatment, a great proportion will relapse within 12 - 24 months.~      Several studies in patients with lung cancer suggested a possible favourable association~     between the increased presence of immunologically active cells in the tumour and survival.~     Nivolumab and ipilimumab are proteins, which help your immune system to attack and destroy~     cancer cells by your immune cells. Early clinical trials with nivolumab and ipilimumab have~     shown activity in a broad range of cancers, including SCLC.~      The aim of the current study is to investigate the efficacy (how well the treatment works)~     and tolerability (how severe the side effects are) of the standard treatment (chemotherapy~     and radiotherapy) alone, compared with the standard treatment followed by nivolumab and~     ipilimumab in patients with limited SCLC.~   "
116215|NCT02046317|"~     For bone fracture injuries, particularly femur fractures, the femoral nerve block (FNB) can~     provide a fast and effective means to control pain. However, this method is not always~     employed due to the fact that positioning the needle and therefore the block can be time~     consuming and challenging, and if not precisely placed, the nerve block results in poor pain~     control. Traditional methods for nerve blockade include the blind technique and use of a~     peripheral nerve stimulator (PNS). Unfortunately, neither of these methods provide a reliable~     guide for needle placement and can lead to intraneural placement and/or failed attempts.~      Hypothesis: When ultrasound technology is implemented in this procedure it may improve the~     success rate when compared to other techniques by providing real-time visual guidance. This~     may result in a faster and prolonged pain relief reducing the amount of analgesics needed.~   "
116216|NCT02046304|"~     The goal of this clinical research study is to find the highest safe dose of gemcitabine that~     can be given with radiotherapy before surgery to treat sarcoma. This study will also look at~     how well this treatment controls sarcoma.~   "
116600|NCT02041286|"~     The purpose of this study is to determine if subjects who have diabetes can operate the~     Investigational Blood Glucose Monitoring System (BGMS) without training and obtain valid~     glucose results.~   "
116184|NCT02046720|"~     The bispectral index (BIS) is commonly used in anesthesia to evaluate the depth of sedation.~     Numerous studies in adults have shown good correlation between bispectral index values and~     depth of sedation regardless of the hypnotic drug used. Requirements of intravenous and~     inhalational hypnotic agents to suppress consciousness decrease with age. A study showed that~     the loss of consciousness (LOC) was obtained with lower concentrations of sevoflurane in~     elderly than in young adults, but at identical BIS values, so that BIS would predict depth of~     sedation better than drug monitoring. This result incited the use of bispectral index~     monitoring to overcome the significant pharmacological variability, especially in elderly.~     Nevertheless, another research with a comparable methodology during propofol-induced~     anaesthesia provided higher BIS values at LOC in elderly compared to younger patients. In~     these two trials, LOC was defined differently: either by absence of verbal response~     corresponding to loss of eyelash reflex (LOER) or by absence of response to prodding [(OAA/S)~     <2)]. Otherwise electromyographic activity (EMG) was not taken in account. As high EMG level~     (greater than 50 decibels) could create subtle artifact signal pollution without necessarily~     being displayed as artifacts, this would be misinterpreted by the BIS algorithm as EEG~     activity and assigned a spuriously increased BIS value.~      The main objective of our study was to specifically evaluate BIS values according to age~     during propofol-induced sedation. LOC was measured by obtaining an OAA/S score <2 (OAA/S2),~     or a deeper sedation criterion: loss of eyelash reflex (LOER). The secondary objective was to~     specify the influence of EMG on the displayed BIS values and its age-related modifications.~   "
116185|NCT02046707|"~     This is a single-centre open randomized parallel-group study. Patients will be selected at~     random to be included in group 1: eccentric rehabilitation or group 2: conventional~     rehabilitation.~      In addition, a group of healthy volunteers aged between 20 and 85 years will also be~     recruited. This group will make it possible to evaluate, during the two exercise sessions,~     mechanisms of adaptation linked to eccentric exercise vs concentric exercise.~   "
116186|NCT02046694|"~     This research is being done to determine if allopurinol can change the metabolism of the oral~     chemotherapeutic medication 6-mercaptopurine (6-MP) in children with acute lymphoblastic~     leukemia (ALL). 6-MP is originally started at a standard dose in children with ALL, but the~     dose is adjusted according to the absolute neutrophil count (ANC). Occasionally, 6-MP doses~     need to be increased in order to get the ANC into a specific target range. Also, increasing~     the 6-MP dose can lead to unwanted side effects, such as inflammation of the liver as shown~     by increases in laboratory values (ALT, aspartate aminotransferase (AST), bilirubin), nausea,~     and abdominal discomfort. Previous studies in children with inflammatory bowel disease has~     shown that combining allopurinol with 6-MP can decrease side effects associated with high~     doses of 6-MP and also increase the efficacy of 6-MP. Allopurinol is approved by the Food and~     Drug Administration for the treatment of tumor lysis syndrome in ALL. Through this research~     study, we hope to show that the combination of allopurinol and 6-MP will be safe, tolerable,~     and effective in children with ALL.~   "
116187|NCT02046681|"~     Half of the people over the age of 65 are not functioning at their optimal level because of~     interference from pain. > 50% of older adults had taken prescriptions of pain medication~     beyond a 6-month period. In Emergency Department 80% of visits involving conditions with~     painful component. The study aims to observe and check side effects of most frequently pain~     killers prescribing at home to patients over 65 years old after a visit in emergency~     department.~   "
116188|NCT02046668|"~     This pilot study will obtain preliminary evidence on which to base sample size calculations~     for a future trial of whether spironolactone (an aldosterone blocker) reduces knee pain in~     older people with symptomatic OA knee when given in addition to usual analgesia. Aldosterone~     is known to be pro-inflammatory, and spironolactone suppresses cytokine production in chronic~     arthritis. This application builds on previous work by the applicants showing that~     spironolactone significantly improved quality of life (particularly pain) in frail older~     people. The investigators will recruit 86 people (aged 70 years or over) with well-defined OA~     knee to 25mg spironolactone daily or to matching placebo for 12 weeks. The primary outcome is~     the between group difference in change in WOMAC pain sub-score at 12 weeks. Secondary~     outcomes are the WOMAC stiffness and physical function subscales and health related quality~     of life (EQ-5D). Morning cortisol levels will be measured to assess the effect of~     mineralocorticoid receptor blockade on glucocorticoid levels, which may mediate the~     anti-inflammatory effect of spironolactone; and urinary CTX-II, and serum matrix~     metalloproteinase-3 (MMP-3) will be measured as biomarkers as both are sensitive to the~     effects of pharmacological interventions for osteoarthritis.~   "
116189|NCT02046655|"~     Corifollitropin alfa has been shown to result in significantly more oocytes compared to daily~     recombinant follicle stimulating hormone (recFSH) (Devroey et al., 2009), probably due to the~     higher circulating FSH activity during the first days of stimulation. For this reason, the~     use of corifollitropin alfa might be beneficial in poor responders in whom the number of~     oocytes retrieved is crucial for success.~      The purpose of this study is to evaluate the effectiveness of corifollitropin alfa treatment~     compared to daily recFSH in terms of the number of oocytes retrieved in a defined population~     of poor responder patients undergoing intracytoplasmic sperm injection (ICSI) using~     gonadotrophin releasing hormone (GnRH) antagonists.~   "
116217|NCT02046291|"~     This is a single institution, phase I dose escalation study of weekly romiplostim post~     umbilical cord blood transplantation in patients who fail to achieve platelet engraftment by~     day +30. Engraftment is defined as a platelet count ≥ 20 x 109/L on 3 consecutive~     measurements without transfusion for 7 days. Romiplostim is administered at the assigned dose~     as 6 weekly injections beginning by day +42 post transplant. Up to 4 dose levels (4, 6, 8,~     and 10 mcg/kg/dose) will be evaluated with the maximum tolerated dose (MTD) of romiplostim~     determined by using the Continual Reassessment Method (CRM). The goal of this CRM will be to~     identify 1 of the 4 dose levels which corresponds to the desired maximum toxicity rate of 20%~     or less.~   "
116218|NCT02046278|"~     A Pilot Study in Subjects Undergoing circular stapled anastomosis created within 10 cm of the~     anal verge.~   "
116601|NCT02041273|"~     A relative bioavailability study of commercial palbociclib free base hard capsules to the~     isethionate salt palbociclib capsules ( used in Phase 1 and 2 studies) under different~     fasting conditions.~   "
126725|NCT01908738|"~     The purpose of this study to determine effectiveness of paracervical block, lidocaine spray~     and only oral analgesic drugs for pain relief during endometrial biopsy.~   "
116190|NCT02046642|"~     Maternal rest in left lateral decubitus position increases fetal urine production rate which~     in turn increases the estimated amniotic fluid volume (AFV) in uncomplicated pregnancies. The~     estimated AFV increases faster at initial periods, particularly during the first, second and~     third 15 minute periods of the maternal rest in the left lateral position. Although at each~     successive 15 minute period the estimated AFV continues to increase, the increase rate is~     always less in the following period. The AFV increase curve resembles the characteristics of~     a saturation curve and finally the estimated AFV increase stops approximately at the second~     hour.~      Although maternal rest in left lateral decubitus position increased the estimated AFV in the~     previous studies, the sole effect of left lateral position or the sole effect of rest was not~     evaluated, and the results of resting in another position is not known. In addition, it is~     hard for a pregnant woman to maintain the left lateral position continuously.~      Rest in the prone position is not practical for a pregnant woman, particularly after the~     first trimester of the pregnancy and supine position may cause several hypotension related~     symptoms including nausea, anxiety, lightheadedness, shortness of breath, perspiration,~     tachycardia and urge to change position. Thus, right lateral position may be an alternative.~      The purpose of this study is to analyze the effect of maternal rest in the right lateral~     decubitus position on estimated amniotic fluid volume in comparison with the left lateral~     position. Because, in both groups the mothers rested, our secondary aim was to obtain data~     for the contribution of maternal rest to the AFI increase observed in the previous studies.~   "
116191|NCT02046629|"~     Primary Objective:~      To assess the pharmacokinetic (PK) parameters of teriflunomide after a single oral dose of 14~     mg administration in Chinese healthy subjects~      Secondary Objective:~      To assess the safety and tolerability after a single oral dose of 14 mg teriflunomide in~     Chinese healthy subjects~   "
116192|NCT02046616|"~     This Phase IIIb, open-label, single-arm study will evaluate the safety, efficacy, and~     tolerability of SC tocilizumab (RoActemra/Actemra) in monotherapy or in combination with~     methotrexate or other non-biologic DMARDs in participants with active RA who are naive to~     tocilizumab. Participants will receive tocilizumab 162 milligrams (mg) subcutaneously weekly~     (QW) for 24 weeks.~   "
116193|NCT02046603|"~     This open-label study will evaluate the efficacy and safety of RoActemra/Actemra~     (tocilizumab) as monotherapy or in combination with methotrexate or other non-biologic DMARDs~     in patients with active rheumatoid arthritis and an inadequate response to to current~     non-biologic DMARD therapy or the first anti-TNF agent. Patients will receive~     RoActemra/Actemra 162 mg subcutaneously weekly for 52 weeks.~   "
116194|NCT02046590|"~     There is a worldwide trend to minimally invasive interventions, which results in increasing~     numbers of interventions performed outside of the operating room. Currently, approximately 12~     to 15% of total anaesthetic workload is non-operating room anaesthesia (NORA) and this~     anaesthetic activity is increasing.~      Many of these interventions need supplementary comfort measures to have relaxed patients and~     high success rates. Endoscopic retrograde cholangio-pancreatography (ERCP) is performed~     >50,000 times per year in the U.S.,and is a typical minimally invasive intervention that~     needs patient sedation.~      There is a controversy about the optimal comfort intervention in minimally invasive~     interventions and in particular in ERCP. Two different approaches to insure patients' comfort~     have been proposed: general anaesthesia with endotracheal intubation and mechanical~     ventilation or sedation with spontaneous ventilation.~      Well-performed studies on sedation versus general anaesthesia using a randomized controlled~     trial design with observer blinding will contribute to improve the decision-making for the~     optimal comfort measures in minimally invasive procedures. At our knowledge such a randomized~     controlled trial has not been reported before. The investigators hypothesize that deep~     sedation without tracheal intubation will achieve similar success rates for ERCP as general~     anaesthesia and will have similar rates of harmful postoperative effects.~      The primary aim of this trial is to demonstrate that the success rate of ERCP is not inferior~     in patients randomized to deep sedation without orotracheal intubation vs general anesthesia~     with orotracheal intubation. Secondary aims include a comparison between randomization groups~     of patient safety, patient and endoscopist satisfaction, duration of patient recovery and of~     anesthesia procedure.~   "
116195|NCT02046577|"~     The main purpose of this study is to determine whether weekly oral vitamin D supplementation~     is effective to prevent acute respiratory tract infections in children. The hypothesis of the~     study is that vitamin D supplementation reduces the incidence and severity of acute~     respiratory tract infections in children.~   "
116196|NCT02046564|"~     To evaluate the efficacy and the safety of ASC-01 (aripiprazole/sertraline combination)~     compared to sertraline monotherapy in patients with major depressive disorders who have~     responded incompletely to sertraline monotherapy.~   "
116197|NCT02046551|"~     The purpose of this study is to evaluate atomoxetine's effects on the rewarding and~     reinforcing effects of nicotine in a controlled human laboratory study with 24 otherwise~     healthy nicotine dependent subjects. It is hypothesized that atomoxetine will attenuate the~     negative effects of nicotine.~   "
116198|NCT02046538|"~     The purpose of this study is to establish the safety of Zaltrap in patients who undergo~     pre-operative chemotherapy with Zaltrap. The investigators hypothesize that Zaltrap my impact~     colorectal cancer growth and metastasis.~   "
116199|NCT02046525|"~     Ten healthy volunteers will be recruited to receive either an autologous stool transplant or~     a saline enema to determine if autologous fecal microbiota therapy will be able to rapidly,~     and safely, restore a patient's fecal microbiome after antimicrobial exposure.~   "
116200|NCT02046512|"~     The purpose of this study is to evaluate the effectiveness of bacteria called Lactobacillus~     GG, a Probiotic, in preventing the growth of resistant bacteria in the digestive tract in~     patients on broad spectrum antimicrobials.~   "
116201|NCT02046499|"~     This is a randomized trial comparing oxytocin versus oxytocin + syntometrine in the~     prevention of post partum haemorrhage in patients undergoing caesarean section~   "
116219|NCT02046265|"~     The project is a clinical behavioral research project based at University of Pennsylvania.~     The goal of this research is to design a brief clinic-based, Nurse Practitioner-guided, and~     theory-based health promotion intervention to enhance cervical cancer prevention among young~     women ages 18-26 living in economically disadvantaged urban communities. The investigators~     will evaluate the intervention for feasibility, acceptability and preliminary efficacy.~   "
116290|NCT02045342|"~     This study will investigate the effects of hydrothermally modified starch (SuperStarch) in~     adults. SuperStarch, originally developed as a drink for children with glycogen storage~     disease, is a slow digestible carbohydrate, maintaining blood sugar levels over extended~     periods. Therefore, it could be beneficial to exercise and mental performance, and could~     possibly have fat loss effects by increasing feelings of fullness. In this study, measures~     will be taken in 25 men to assess mental function, appetite, and metabolism to determine the~     processes involved in possible fat loss.~   "
116202|NCT02046486|"~     This is a single-center, prospective, randomized, single-blind, investigator initiated,~     pharmacokinetic/pharmacodynamic study of parallel design.Patients with ST elevation~     myocardial infarction (symptom onset<12 hours), undergoing primary percutaneous coronary~     intervention, who are P2Y12 inhibitor naïve, will be randomized after informed consent,~     immediately after diagnostic coronary angiography, in a 1:1 ratio to either:~        -  Ticagrelor 180mg loading dose, in the form of 2 whole tablets administered per os in the~          supine position (standard administration)~        -  Ticagrelor 180mg loading dose, in the form of 2 tablets crushed and dispersed in~          purified water and administered per os with 1-minute-stay in a 60-70 degrees~          semi-upright sitting position Platelet reactivity assessment will be performed at~          randomization (Hour 0) and at 0.5, 1, 2, 4 and 6 hours after randomization, using the~          VerifyNow assay, in platelet reactivity units (PRU). The cutoff >208 PRU will be used~          for definition of high platelet reactivity (HPR). All platelet reactivity assessments~          will be performed by a physician blind to the actual treatment given. Additional blood~          samples will be collected at the same time points for pharmacokinetic analysis. These~          samples will be collected in vacuum tubes with lithium heparin and will be kept in ice~          until centrifugation (3000 rpm at 4°C for 10 min, within 30 min of sampling). The~          resultant plasma will be transferred into a plain polypropylene tube (screw cap) and~          stored at or below -20°C until analysed.~   "
116203|NCT02046473|"~     To determine if ultrasound measurements can accurately measure the blood pressure of flow~     across a stent that has been placed in a portal vein to reduce portal vein pressure known as~     Transjugular Intrahepatic Porto-Systemic shunts or TIPS.~   "
116204|NCT02046460|"~     The primary objective is to demonstrate the non-inferiority of treatment with ASA to~     anti-coagulant treatment with vitamin K antagonists in patients after a cervical artery~     dissection (CAD).~   "
116205|NCT02046447|"~     The main purpose of this study is to investigate primary cervical dystonia as compared to~     healthy control subjects and DYT 1 dystonia as compared to healthy control subjects by~     examining cognitive measures, physical measures, and structural and functional magnetic~     resonance imaging (MRI).~      The secondary aim of this study is to investigate a specific drug therapy for primary~     cervical dystonia to develop a functional MRI (fMRI) research paradigm. The drug,~     trihexyphenidyl, is FDA approved to treat Parkinson's Disease and is commonly prescribed by~     physicians as a treatment for symptoms of primary cervical dystonia.~   "
116206|NCT02046434|"~     This is a Phase I clinical trial of the FDA approved drug Glycerol Phenylbutyrate to see if~     phenylbutyrate can increase the removal of alpha-synuclein from the brain into the~     bloodstream. Alpha-synuclein forms abnormal protein deposits in dopamine neurons and is~     believed to cause the death of brain cells, leading to Parkinson's Disease.~   "
116207|NCT02046421|"~     This phase I trial studies the side effects and best dose of gemcitabine hydrochloride and~     mifepristone when given together with carboplatin in treating patients with breast cancer~     that is metastatic or cannot be removed by surgery or recurrent or persistent ovarian~     epithelial, fallopian tube, or primary peritoneal cancer. Drugs used in chemotherapy, such as~     carboplatin and gemcitabine hydrochloride, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Steroid hormones can~     cause the growth of cancer cells. Hormone therapy using mifepristone may fight breast and~     ovarian cancer by lowering the amount of steroid hormone the body makes. Giving carboplatin~     and gemcitabine hydrochloride together with mifepristone may be an effective treatment for~     breast, ovarian epithelial, fallopian tube, or primary peritoneal cancer.~   "
116208|NCT02046408|"~     This study tests the use of handheld computer tablets to promote the integration of 5A's~     (Ask, Advise, Assess, Assist, Arrange) for smoking cessation in academic and community~     primary care clinics. Although most patients receive the ask and advise steps, only~     slightly more than half are assessed for readiness to change, less than half receive~     assistance in changing, and only 9% have an arranged follow-up. While the large majority~     of primary care providers support the 5A's model, negative attitudes and the lack of time,~     knowledge, and cessation skills are common obstacles. Alternate service delivery systems that~     address these obstacles and evidence-based strategies to promote their implementation are~     needed to improve provider adherence and 5A's fidelity.~   "
116209|NCT02046395|"~     The purpose of this study is to study the effect of blocking the renin angiotensin system on~     urinary free light chain excretion as compared to urine microalbumin creatinine ratio in~     subjects with type 2 diabetes. The long term goal is to assess urinary free-light chains as a~     biomarker of earlier detection of kidney function impairment in subjects with diabetes~     mellitus.~   "
116210|NCT02046382|"~     This study is being done to evaluate the scheduled use of intravenous (IV) acetaminophen~     among cesarean section patients. The study hopes to find out if patients who receive~     scheduled IV acetaminophen for 48 hours following delivery have lower self-reported pain~     scores and use less narcotic pain medication than patients who do not receive IV~     acetaminophen.~   "
116211|NCT02046369|"~     A study to evaluate efficacy and safety of flexibly dosed Lurasidone in children and~     adolescents with bipolar I depression~   "
116212|NCT02046356|"~     The investigators aim to investigate the related risk factors and the independent risk~     factors of early recurrence, the rate of disease free survival and the rate of recurrence,~     furthermore, develop a rating system of risk factors.~   "
116213|NCT02046343|"~     The purpose of this study it to determine if a promotora-led intervention that takes a~     comprehensive, multi-level, community-based approach to promoting physical activity (PA) is~     effective among a particularly underserved segment of Latinas. We hypothesize that Latinas in~     the promotora-led PA Intervention will significantly increase minutes per week of~     moderate-to-vigorous physical activity (MVPA) compared to Latinas in the attention-control~     group.~   "
116253|NCT02045823|"~     To demonstrate clinical substantial equivalence of 3D OCT-1 Maestro as comparable to the~     commercially available iVue and NW-300. Also, to demonstrate clinical substantial equivalence~     of 3D OCT-2000 Maestro as comparable to the commercially available NW-300.~   "
116254|NCT02045810|"~     Surgical Pleth index is a novel device aimed for measurement of intraoperative nosiseption.~     It has not been tested on small children. The aim of this study is to measure, whether there~     is a difference in nosiception measured by SPI in a group receiving local anesthetics prior~     to operation compared to group receiving plasebo.~   "
116220|NCT02046252|"~     Substance use, particularly the compulsive behaviors associated with addiction, lead to~     unhealthy behaviors including non-adherence to antiretroviral therapy (ART) and treatment~     failure. High on the list of disorders leading to non-adherence is heroin addiction as a wide~     range of impulsive, high-risk behaviors accompanies it. The science of adherence would be~     improved by developing new methods to prevent relapse to heroin addiction, especially methods~     that can be used in settings that are not limited by the aims to test such a method using an~     implantable naltrexone formulation (IN) that is approved in Russia and blocks opioid effects~     for 3 months. The efficacy of the IN should be better than oral naltrexone (ON) because it~     does not depend on daily behavior to take a tablet and maintains a constant plasma level for~     months, which should result in sustained blockade, less relapse, and better ART adherence and~     treatment response.~   "
116221|NCT02046239|"~     Closure of the skin after liver resection (surgery to remove part of the liver) may be~     achieved by one of several methods. The standard method at our institution is to use~     stainless steel staples to adjoin the two sides of skin. Alternatively, a continuous~     absorbable suture may be used to sew the skin together.~      The ideal method of closure should be safe, effective, associated with minimal patient~     discomfort and have a good cosmetic result. At present, there is no scientific evidence to~     describe which method is most suitable following liver resection.~      The primary aims of this study is to investigate which method (subcuticular sutures vs~     staples) offers the best result in postoperative rate of (1) skin infection, (2) skin~     dehiscience (separation of skin) and (3) time taken to perform skin closure. In addition, we~     are interested in which method is best for patient satisfaction and cosmetic appearance and~     which method is most cost effective.~   "
116222|NCT02046226|"~     A Prospective, Randomized, Single-center Pilot Study of The OxyGenesys(TM) Dissolved Oxygen~     Dressing to Improve Chronic Wound Healing after REvascularization for Critical Limb Ischemia.~   "
116223|NCT02046213|"~     The purpose of this study is to determine the metabolism and excretion of [14C]E2006 in~     healthy male subjects.~   "
116224|NCT02046200|"~     Current pharmacotherapies for alcohol use disorders (AUDs) have limited efficacy. Thus, the~     development of effective treatments for AUDs represents an important public health objective.~     Repositioning, i.e. using existing approved drugs for other indications, represents a fast~     and economically feasible approach for drug development. Ivermectin (IVM) is an FDA-approved~     antiparasitic medication that can significantly reduce alcohol intake in mice, suggesting~     that it may be useful in the treatment of AUDs in humans. The goal of this project is to~     provide key clinical evidence that IVM can be repositioned as a novel therapeutic agent to~     treat AUDs.~   "
116225|NCT02046187|"~     This study aims to see if reducing blood sugar and increasing ketones (a metabolic product~     that comes from using fats for energy) can increase survival and enhance the the effects of~     standard radiation and chemotherapy treatments used to treat glioblastoma multiforme (GBM).~     These changes occur from use of a ketogenic diet. This research has 2 goals:~        1. Show that patients can tolerate the diet and maintain low blood glucose and high blood~          ketone levels.~        2. Show if this diet enhances the effectiveness of standard treatment by prolonging~          survival of patients with a GBM.~   "
116226|NCT02046174|"~     This is a clinical research study of an investigational (FDA IND-BB 10091) treatment for~     patients with advanced colorectal cancer that no longer responds to standard therapies.~      The treatment is being evaluated for its effect on tumor growth. It consists of the placement~     (implantation) of small beads that contain mouse renal adenocarcinoma cells (RENCA~     macrobeads). The cells in the macrobeads produce substances that have been shown to slow or~     stop the growth of tumors in experimental animals and veterinary patients. It has been tested~     in 31 human subjects with different types of cancers in a Phase I safety trial. Phase II~     studies in patients with colorectal, pancreatic or prostate cancers are in progress~   "
116227|NCT02046161|"~     The quality of colon preparation plays a crucial role in colon cancer prevention, especially~     for right side colon. So far, colon cleansing is still not adequate in up to 10-30%~     colonoscopies and leads to increase risk of missed neoplasm.Recent literature on colonoscopy~     preparation revealed the dosage, timing and dietary restriction could influence colon~     preparation quality. Previous study demonstrated colon cleansing on the day of colonoscopy~     had better cleansing quality. However, the ideal colon preparation is not yet determined. the~     investigators herein consider the in-hospital setting of colon cleansing room can ensure~     better colon cleansing timing, colon preparation evaluation reliability and patient's~     compliance of colon cleansing. Therefore, the investigators design a prospective randomized~     controlled trial to compare cleansing quality between the setting of colon cleansing room and~     the standard colon preparation.~   "
116228|NCT02046148|"~     Evaluate the safety and immunogenicity of the trivalent group B streptococcus vaccine in~     healthy pregnant women. The study will also evaluate the levels of GBS serotype-specific~     antibodies in infants, placental transfer from the pregnant women to the infant and levels of~     antibodies in the breast milk.~   "
116229|NCT02046135|"~     The proposed study will investigate the effect of sodium bicarbonate on the prevention of~     acute kidney injury in children undergoing cardiac surgery with cardio-pulmonary bypass. The~     investigators hypothesize that the occurrence of acute kidney injury will be less in children~     treated with sodium bicarbonate in the perioperative period when compared to placebo. The~     specific aims of this proposal are as follows:~      1. To institute a prospective, randomized, double-blinded, placebo-controlled trial in~     pediatric subjects undergoing cardiac surgery to determine the efficacy of sodium bicarbonate~     on prevention of acute kidney injury as measured by pRIFLE criteria. 2. To examine whether~     treatment with sodium bicarbonate modifies the duration of acute kidney injury, fluid~     balance, hospital length of stay, need for dialysis, and progression to kidney failure. 3. To~     determine the relevance of NGAL as a biomarker to predict development of acute kidney injury.~   "
116255|NCT02045797|"~     GSK2140944 belongs to a novel structural class of antibiotics - Bacterial Type II~     Topoisomerase Inhibitors (BTI). This is a Phase II, randomized, two-part, multicenter study~     designed to select the optimal dose by further characterizing the safety, tolerability and PK~     of GSK 2140944 and by evaluating efficacy in subjects requiring in-patient medical care to~     treat their suspected or confirmed Gram-positive acute bacterial skin and skin structure~     infections (ABSSSI). The selected dose will be used in future studies.~   "
116230|NCT02046122|"~     The primary hypothesis is that chemotherapy followed by donor lymphocyte infusion (DLI) from~     HLA-haploidentical donors is a safe procedure that will not cause Graft versus Host Disease~     (GVHD) or increased treatment-related mortality. The Investigator further believes that this~     will improve outcomes of elderly patients with high-risk AML or MDS compared to chemotherapy~     alone, and that that this benefit will be even greater in donor-recipient pairs that share~     maternal-fetal microchimerism or non-inherited maternal antigen (NIMA) mismatch. A large part~     of this trial will include immune function assays as well as assessments of efficacy,~     toxicity, and GVHD. Because this therapy may be a tolerable alternative to allogeneic~     hematopoietic stem cell transplantation (alloHSCT) for elderly patients, the Investigator~     will validate functional measurements (e.g. Comprehensive Geriatric Assessment (CGA)) with~     biologic correlates (cytokine and genomic profiles) and clinical outcomes.~   "
116231|NCT02046109|"~     The objective of this trial is to compare the success (as assessed by a pre-defined set of~     outcome) of failing composite resin restorations that are repaired using diamond bur induced~     surface abrasion, to those that are completely replaced.~      It is hypothesized that both treatment will have comparable success rate.~   "
116232|NCT02046096|"~     This prospective, multicenter, single-arm clinical study will further evaluate the safety and~     effectiveness of Cook's permanent and retrievable inferior vena cava (IVC) filters~     (specifically, the Günther Tulip® Vena Cava Filter and Cook Celect® Vena Cava Filters) in~     patients in need of temporary or permanent IVC filter placement for the prevention of~     pulmonary embolism.~   "
116233|NCT02046083|"~     The primary purpose of the protocol is to evaluate the efficacy of a protocol for induction~     of tolerance to peanut ingestion increasing doses. The secondary purpose is to determine the~     interest of a prolonged maintenance therapy~   "
116234|NCT02046070|"~     This is a phase 2, multicenter, open-label study in patients with Newly Diagnosed Multiple~     Myeloma (NDMM) who have not received prior systemic treatment for multiple myeloma (MM) and~     who are ineligible for high-dose therapy (HDT)-stem cell transplantation (SCT) due to age~     (ie, ≥ 65 years) or comorbid disease(s) or with Relapsed and/or Refractory Multiple Myeloma~     (RRMM)).~   "
116235|NCT02046057|"~     The purpose of the study is to determine if it is possible to identify and perform a needle~     biopsy of the sentinel lymph node. The investigators hope to identify breast cancer cells in~     the lymph nodes under the arm without making an operation necessary.~      The rationale for this study is that for patients without enlarged lymph nodes under the arm,~     sentinel lymph node biopsy is the standard way of determining if breast cancer has spread to~     the lymph nodes under the arm. While the complications from a sentinel lymph node dissection~     are less than that of a complete axillary lymph node dissection, sentinel lymph node~     dissection still carries small risks of arm swelling, decreased movement, fluid collections,~     nerve injury, and pain. Furthermore, the majority of sentinel lymph nodes do not contain~     cancer. The investigators hope to develop a method to find cancer in the axillary lymph nodes~     and avoid the complications of an operation.~   "
116236|NCT02046044|"~     Study hypothesis: Comparing the effect of digoxin and ivabradine in chronic heart failure~     patients with a left ventricular ejection of 35% or lower and sinus rhythm with heart rate 70~     beats per minute or higher, and who are taking maximal dose of a beta blocker if tolerated.~   "
116237|NCT02046031|"~     To explore the rule of absorption, distribution, metabolism and elimination after intravenous~     administration of Ginkgolides Meglumine Injection healthy subjects. The plasma drug profiles~     will be important to assess the potential clinical drug-drug interactions.~   "
116238|NCT02046018|"~     In Sub-Saharan Africa (SSA), many children die from diarrhoea, acute respiratory illness~     (ARI) and malaria, despite well- recognized, inexpensive and highly effective treatments,~     since health access and human resources are limited. Healthy Child Uganda (HCU) is a~     Ugandan-Canadian partnership that since 2003, has developed, implemented and evaluated a~     Village Health Volunteer (VHV) program in 175 rural villages. Volunteers, selected by peers,~     provide health education and refer sick children. Volunteer retention (94%) and significant~     decreases in child deaths are remarkable. Now, HCU wonders whether VHV scope can extend to~     provide treatment for sick children using Oral Rehydration Salts (ORS)/Zinc, antibiotics, and~     antimalarials. Use of lay providers in this capacity, called integrated community case~     management (iCCM), has been proposed as a potential inexpensive solution to SSA's human~     health resource crisis.~      PRIMARY QUESTION: In rural southwest Uganda, can iCCM provided by lay volunteers, improve the~     proportion of children with diarrhoea receiving ORS/Zn, ARI receiving antibiotics, and~     fever/malaria receiving antimalarials? Secondary study questions consider VHV capacity to~     prescribe appropriate drug, dose, duration; iCCM acceptance by family, and VHV; VHV~     retention/motivation; program cost. Selected VHV will be iCCM trained then receive treatments~     for distribution. Qualitative and quantitative methods including household surveys, and focus~     groups will consider pre/post intervention differences and differences in control and~     intervention populations. A research short course and micro research grants (~ $3000 to~     multidisciplinary groups pursuing relevant questions) will promote health system evaluation~     capacity. Lessons learned are critical as SSA countries move forward in planning for~     increased iCCM programming.~   "
116239|NCT02046005|"~     The purpose of this study is to understand how personalized risk factors for rheumatoid~     arthritis (RA) may impact willingness to change behaviors associated with RA. The~     investigators have developed a personalized risk estimator for RA based on demographics,~     family history, biomarkers and behaviors related to RA risk. Eligible participants have a~     first degree relative with RA but do not have RA themselves. Participants who meet~     eligibility and consent to the study will be randomized to receive either standard~     information about RA, the online personalized RA risk tool, or the online personalized RA~     risk tool with guidance from a health educator. Participants will be followed to measure~     willingness to change RA risk behaviors. The investigators hypothesize that participants who~     receive the online personalized RA risk tool and health education will be more willing to~     change RA risk behaviors compared to participants that receive standard RA information.~   "
116256|NCT02045784|"~     The objective of this study is to define the amount of dietary iodine needed per day during~     the first six months of life. The hypothesis is that the current recommended iodine intake in~     infants is set too high.~   "
133441|NCT01820637|"~     To determine whether the Boston Scientific nitinol drug-eluting stent shows acceptable~     performance at 9 months when treating Superficial Femoral (SFA) and/or Proximal Popliteal~     Artery (PPA) lesions.~   "
116240|NCT02045992|"~     Heart failure patients represent a group of individuals at higher risk for cardiac~     arrhythmias. There is a perception that caffeine consumption may represent an increase in~     this risk. Although the medical staff and health professionals suggest a reduction in the~     intake of this substance to patients considered at risk, there is no scientific proof for~     this recommendation.~      Some animal studies suggest a possible association between arrhythmias and caffeine use with~     higher doses, but this finding did not appear in human studies. In particular, little is~     known about the association between caffeine consumption and arrhythmias in patients with~     heart failure, especially at higher doses of consumption.~      More specific and safe guidelines on caffeine consumption are needed.~   "
116241|NCT02045979|"~     Investigate the pharmacokinetics, safety and tolerability of BI695501 and to establish~     pharmacokinetic similarity of BI 695501 to adalimumab.~   "
116242|NCT02045966|"~     The primary purpose of this study is to assess the effect of the~     Daclatasvir/Asunaprevir/BMS-791325 fixed dose combination (FDC) tablet on the~     pharmacokinetics of the cocktail CYP and transporter probe substrates and to assess the~     effect of the DCV 3DAA FDC [DCV 3DAA FDC = fixed dose combination formulation of 3~     direct-acting antivirals (3DAA) (DCV 30 mg, ASV 200 mg, and BMS-791325 75 mg)] + BMS-791325~     75-mg single-agent tablet on the Pharmacokinetic (PK) of the cocktail CYP and transporter~     probe substrates.~   "
116243|NCT02045953|"~     The VENTOLIN Mini-Spacer is being developed in order to support patients in the Emerging~     Markets and Asia Pacific regions who do not have access to affordable spacers. The aim of~     this exploratory study is to investigate whether the systemic exposure for fluticasone~     propionate (FP) and salmeterol observed with the VENTOLIN Mini-Spacer is comparable to the~     systemic exposure for FP and salmeterol observed with the Trudell Aerochamber Plus spacer for~     both FLIXOTIDE and SERETIDE Metered Dose Inhaler (MDI) products. There will be four study~     periods in the study and all participants will receive four study treatments during the~     study. The total duration of study including screening, treatment period, washout period, and~     follow-up period will be 58 days. Study is planned to enroll 20 healthy subjects.~      VENTOLIN is a registered trademark of GlaxoSmithKline. FLIXOTIDE is a registered trademark of~     GlaxoSmithKline. SERETIDE is a registered trademark of GlaxoSmithKline.~   "
116244|NCT02045940|"~     This study is the first administration of GSK2881078 to humans. The intention of this study~     is to provide sufficient confidence in the safety of the molecule to inform progression to~     further repeat dose and proof of concept studies. This study will include approximately 52~     subjects and consist of 2 parts. Part A will consist of two cohorts of 8 subjects to assess~     the safety, tolerability, and pharmacokinetic (PK) of ascending single oral doses of~     GSK2881078. Cohorts 1 and 2 will include healthy male subjects. Part B (Cohorts 3, 4 and 5)~     will include three cohorts of 12 healthy male subjects to examine the safety, tolerability,~     PK, and pharmacodynamic (PD) of repeated doses of GSK2881078 over 14 days. The total duration~     of the study including screening and follow-up, is not expected to exceed 70 days.~   "
116245|NCT02045927|"~     This study looks to assess whether monitoring sedation status in mechanically-ventilated~     Medical Surgical Intensive Care Unit (MSICU) patients using Bispectral index (BIS)~     monitor-augmented sedation monitoring as opposed to Richmond Agitation Sedation Scale (RASS)~     score is associated with decreased duration of mechanical ventilation.~      Investigators hypothesize that using BIS monitors to help monitor depth of sedation in~     mechanically ventilated ICU patient will result in a decreased duration of mechanical~     ventilation when compared to solely utilizing clinical sedation scales such as RASS.~   "
116246|NCT02045914|"~     The aim of this study is to evaluate calcium ionophore solution on fertilization rate of~     patients during intracytoplasmic sperm injection who have poor ovarian reserve~   "
116247|NCT02045901|"~     The primary objective of this study is to compare the efficacy of Diclegis for the treatment~     of nausea and vomiting of pregnancy (NVP) in pregnant adolescents aged 12 to 17 years with~     placebo.~      The secondary objective of this study is to compare the safety of Diclegis in pregnant~     adolescents aged 12 to 17 years with placebo by assessing differences in the severity and~     occurrence of maternal adverse events (AEs).~   "
116248|NCT02045888|"~     To evaluate the safety and feasibility of adipose-derived regenerative cells injected into~     tears of the hamstring muscle.~   "
116249|NCT02045875|"~     40 subjects with moderate-to-severe asthma will be randomly selected for study in which 20,~     will be monitored for medication use (Dulera 100/5, Dulera 200/5 and Proventil HFA) over 3~     months. These intervention subjects will receive medication use feedback at each visit, while~     the control group will receive the standard of asthma care. Those interventional subjects~     with Dulera adherence<60% will receive feedback based on an asthma adherence disease~     management model protocol, Asthma Adherence Pathway. Intervention clinicians will been~     trained in Motivational Interviewing to reduce subject ambivalence about medication use. The~     primary hypothesis is that subjects who receive medication monitoring and Motivational~     Interviewing adherence strategies will have better asthma control, as measured by the Asthma~     Control Questionnaire, than the control group.~   "
116250|NCT02045862|"~     The purpose of this study is to examine how well the combination of two medicines~     (solifenacin succinate and mirabegron) work compared to each medicine alone in the treatment~     of bladder problems, and how safe they are for long term use.~   "
116251|NCT02045849|"~     This study will be conducted in three parts (Part 1, Part 2 and Part 3). Part 1 of this study~     will evaluate the relative bioavailability of a single dose of GSK2140944 tablet formulation~     compared to the reference capsule formulation under fasted conditions. The effect of food on~     the pharmacokinetics (PK) of a single dose of the tablet formulation will also be assessed.~     Part 2 will evaluate the effect of repeat doses of itraconazole on the pharmacokinetics of~     GSK2140944 following a single dose. A decision will be made whether to use the current~     capsule formulation or the new tablet formulation in Part 2 based upon the safety and PK data~     obtained from Part 1. Part 3 is conditionally based upon progression of the tablet~     formulation from Part 1 and will evaluate the effect of food on the safety, tolerability, and~     pharmacokinetics of the tablet formulation following multiple doses in elderly healthy~     subjects.~   "
116252|NCT02045836|"~     The purpose of this study is to assess the immunogenicity, reactogenicity and safety of the~     GSK Biologicals HZ/su candidate vaccine when its first dose is co-administered with Pneumovax~     23™ vaccine in adults aged 50 years or older.The impact of HZ/su vaccine on Pneumovax 23™~     vaccine immune response will also be evaluated.~   "
116257|NCT02045771|"~     The study's primary goal is to assess the effectiveness of behavioural activation in reducing~     depressive symptoms and re-integrate patients with depression into their personal and~     professional lives thus improving quality of life and helping in attaining and maintaining~     remission of depression. It is aimed at helping patients re-engage with several life areas~     that they may have lost in the course of depressive illness. The intervention is centred on~     behavioural activation (BA) with complementary interventions including recreation activities,~     and behavioural modifications. The study question is: in patients with depressive disorder~     attending a specialized hospital based mood disorders clinic, does the addition of~     behavioural activation program delivered in a group format improve depressive symptoms and~     quality of life compared to treatment as usual after 18 weeks of treatment? Study~     investigators hypothesize that behavioural activation is an effective treatment for~     depressive disorder in patients with depression.~   "
116258|NCT02045758|"~     This study will compare blood collection from the forearm using an investigational device~     TAP20-C to blood collection from the fingertip.~   "
116259|NCT02045745|"~     The purpose of this study is to analyze the safety and feasibility of the implantation of~     autologous mesenchymal stem cells (MSCs) expanded in vitro and administered directly in the~     lung line of suture as a treatment for patients at risk of postoperative air leaks after lung~     resection.~   "
116260|NCT02045732|"~     PF-06342674 (RN168), being developed for the treatment of multiple sclerosis (MS), is an~     antibody that binds to and inhibits the human interleukin-7 receptor, a component potentially~     involved in MS. PF-06342674 (RN168) is expected to play a role in slowing down the~     progression of the disease.~   "
116261|NCT02045719|"~     Cat's claw (Uncaria tomentosa) is a native amazonic plant that exhibits anti-inflammatory and~     antitumor properties. Patients and methods: This prospective phase II study will assess the~     effects of a 100-mg dose of a dry extract of U. tomentosa three times per day on individuals~     with advanced solid tumors, with no further therapeutic options and with at least 2 months~     life expectancy. In addition, several biochemical and inflammatory parameters will be~     analyzed.~   "
116262|NCT02045706|"~     There are many trials measuring the impact of service work on volunteers themselves, but few~     studies measuring the impact of service on the local people. The purpose of this trial is to~     determine whether US and Ugandan health volunteers can make a measurable impact on the health~     of rural Ugandan villagers.~   "
116263|NCT02045693|"~     The purpose of this study is to assess the effects of steady state DCV/ASV/BMS-791325 fixed~     dose combination (FDC) + 75mg BMS-791325 on the Pharmacokinetics (PK) of Methadone in~     subjects with the stable dose of Methadone and on the PK of Buprenorphine in subjects with~     the stable dose of Buprenorphine.~   "
116264|NCT02045680|"~     The use of laparoscopic surgery is continuing to increase in colorectal resection and~     expected reach 80% in the next 10 years. Although laparoscopic (keyhole) or minimally~     invasive surgery can lead to faster recovery it can also put significant stresses on the~     patient's heart and cause fluctuations in blood pressure due to the extreme headdown~     positioning and abdominal insufflation of carbon dioxide gas.~      We have performed several surgical cases under deep neuromuscular block and this has allowed~     surgery to operate at lower abdominal pressures (from 14 down to 8 mmHg). This put less~     strain on the heart and allowed higher cardiac outputs.~      This study will look at whether deep neuromuscular block is beneficial for patients by~        1. Increasing oxygen delivery, measured using oesophageal doppler monitoring of~          cardiovascular variables intraoperatively~        2. Allowing surgery at lower abdominal insufflation pressures if they have a deep block~        3. Reducing patient's analgesic requirements postoperatively in recovery and at 4 hours~   "
116265|NCT02045667|"~     The main objective of this study is to explore whether multiple trials with individual~     patients (N-of-1 trials) can produce a reliable evidence base for coverage decisions on~     clinical and cost-effectiveness of drug treatment for patients with rare diseases. As a case~     study, we will study the clinical and cost-effectiveness of Mexiletine in patients with~     Non-Dystrophic myotonia. The results of this analysis will be compared with the results~     obtained from a recently published international, multi-centre, randomized,~     placebo-controlled trial of Mexiletine in patients with Non-Dystrophic Myotonia~     (clinicaltrials.gov Identifier: NCT00832000).~      The secondary objective of this proposal is to assess whether mexiletine improves myotonia~     measured (both quantitatively and qualitative) in patients with non-dystrophic myotonia.~   "
116266|NCT02045654|"~     To assess the efficacy of decitabine and identify predictors for response to decitabine~     therapy.~   "
116267|NCT02045641|"~     One of the most common postoperative complications after open cardiac surgery is fluid~     accumulation between the pleural membranes or in the pericardial sac. This study investigates~     the consequence of such fluid accumulations on physical performance, recovery-time, cardiac~     and respiratory complications, and quality of life. Half of the participants will be followed~     closely and offered fluid drainage at a low threshold, and half of the participants will~     follow the current postoperative regimen.~   "
116268|NCT02045628|"~     Although obesity surgery is currently the most effective method for achieving weight loss,~     not all patients lose the desired amount of weight and some show weight regain. Previous~     pilot work by the lead researcher shows that successful weight loss is associated with the~     amount of investment the patient feels that they have made in their operation. For example,~     those who feel that it has taken more time and effort to organise, has cost more money, has~     been more disruptive to their family, social and work lives and has caused pain are more~     likely to lose weight after their operation. Therefore, it seems as if the greater the sense~     of investment, the greater the motivation to make the operation a success. The present study~     aims to build on these findings by encouraging weight loss surgery patients to focus on the~     investment they have made, thus making their investment more salient to them. Using a trial~     design, half the patients will be asked to rate and describe the investment they have made in~     their operation just before surgery (focusing on the time and effort to organise the surgery~     etc) and 3 months after surgery (focusing on time off work for recovery, disruption of family~     and friends, pain of surgery, pain of having the stitches removed etc). All patients will~     record their weight, beliefs about food, intentions to change their behaviour and actual~     eating and exercise behaviour at baseline then 3, 6 and 12 months follow up. The impact of~     the investment based intervention will then be assessed to explore whether focusing on the~     investment involved in having surgery improves patient health outcomes by one year.~   "
116272|NCT02045576|"~     SUMMARY Rationale: Fifty-six percent of patients with Obstructive Sleep Apnea (OSA) are~     position dependent, defined as having an AHI, which is at least twice as high in supine~     sleeping position compared to the AHI during sleep in other positions. Standard therapy for~     patients having mild or moderate POSA is treatment with an Oral Appliance Trainer (OAT).~     Recently a new device Sleep Position Trainer (SPT) is been introduced especially for patients~     with POSA.~      Objective: To compare the effect of positional therapy with the SPT versus OAT on~     polysomnographic (PSG) parameters, to evaluate the compliance and measuring the possible~     learning effect that might occur with POSA patients using the SPT for positional therapy over~     a long term.~      Study design: Randomised controlled trial Study population: The participants of the research~     will be recruited from the departments of Otolaryngology and Clinical Neurophysiology, Saint~     Lucas Andreas Hospital, Amsterdam, the Netherlands.~      Participants will be males or females older than 18 years with diagnosis of positional OSA.~      Intervention: The SPT is a sensor positioned in an elastic band attached around the body. The~     SPT measures the body position and vibrates when the patient lies in supine position. Oral~     appliance therapy (OAT) is an intra-oral prosthesis, which holds the mandible in a protrusive~     position. Because of this position more pharyngeal space will be available and the AHI will~     decrease. After randomisation the first group (n=45) will sleep for a period of 90 +/- 2 days~     with the SPT every night. The second group (n=45) will also sleep for a period of 90 +/- 2~     days only with OAT. After this period the PSG is repeated. Long- term outcome in AHI is~     measured by repeating the PSG after 1 year. Main study parameters/ endpoints: Primary~     endpoints; reduction of PSG parameters, in particular AHI, AI, HI, DI, reduction of % of~     sleeping supine sleep position, without disturbance of the sleep quality.~      Secondary endpoints: Outcome of Quality of Life questionnaires; EQ-5D, ESS, FOSQ and MFIQ.~      Compliance and learning effect will also be evaluated for the time period of 3 and 12 months.~     Finally cardiovascular parameters like blood pressure, pulse rate and BMI/neck circumference~     will be assessed.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: The risks for patients participating in this study are negligible.~     Inconveniences of the SPT can be discomfort caused by irritation of the band, difficulties~     with an increased sleeping period on the side or difficulties sleeping with the SPT. This can~     be compensated by the expected improvement of sleep quality caused by the therapy. Possible~     side effects of OAT may be discomfort in the jaw, sensitivity of the teeth and a dry mouth.~     Withdrawing from this therapy means immediate relief of inconveniences.~   "
116273|NCT02045563|"~     -  Our research hypothesis is to show that a certain number of genetic polymorphisms of the~          proteins involved in glucose, lipid and adipocyte metabolism are factors that favour the~          development of steatosis in patients with Type 2 diabetes.~        -  We also wish to evaluate more thoroughly lipid anomalies associated with the presence of~          steatosis, notably with regard to monocyte expression of LDL receptors. We hypothesize~          that hepatic steatosis is accompanied by activation of transcription factors involved in~          lipogenesis, notably SREBP factors. The activation of these factors could cause an~          increase in the expression of LDL receptors, leading to increased LDL catabolism.~        -  Chronological description of the study During an outpatient consultation at the~          endocrinology department, diabetic patients, programmed to undergo an examination to~          assess their diabetes will be invited to participate in the study. Once written informed~          consent has been provided and clinical data has been recorded, patients with type 1 or~          type 2 diabetes will have standard biological examination, which is systematically done~          in such patients (Fasting glycemia, HBA1c, aspartate aminotransferase, alanine amino~          transferase, Gammaglutamyl-transferases, PAL, bilirubin, blood proteins, albuminemia,~          Total Cholesterol total, HDL cholesterol, triglycerides, Sedimentation Rate, C-reactive~          protein, fibrinogen).~      As well as the systematic biological tests, 3 additional tubes will be taken to screen for~     genetic polymorphism in 3 proteins (Microsomal Transfer Protein, Adiponectin receptor - 1,~     Apolipoprotein A - II).~      IN addition, magnetic resonance imaging and magnetic resonance spectroscopy will be done to~     look for the presence of liver steatosis and to measure carotid intima-media thickness.~   "
116274|NCT02045550|"~     To evaluate the effect of a prophylactical therapy with a cough medicine containing ivy~     leaves dry extract on the frequency of recurrent wheezy bronchitis in toddlers, on the~     duration of the bronchitis episodes, on the severity and the additional drug demand. A~     prolonged asymptomatic episode between each wheezy bronchitis due to the therapy is assumed.~   "
116275|NCT02045537|"~     Study to determine the incidence of Bone Fractures in HIV infected patients in Spain~   "
116276|NCT02045524|"~     The objective of this study was to investigate the pharmacokinetics (PK) of JDP-205 injection~     at 10 mg dose administered by intramuscular injection using various injection techniques in~     healthy male and female volunteers after a single dose administration.~   "
116277|NCT02045511|"~     The primary purpose of the study is to develop and test the preliminary efficacy of a~     first-in-kind community-based intervention to provide affordable, accessible and effective~     hearing health care to low-income, minority older adults.~   "
116278|NCT02045498|"~     Compare the quality performance of rescuers and resuscitation outcomes of cardiac arrest~     patients in both groups with and without capnography feedback~   "
116279|NCT02045485|"~     Background:~      Several reports have demonstrated an association between psoriasis and cardiovascular~     diseases. P wave dispersion (PWD) is the most important electrocardiographic (ECG) markers~     used to evaluate the risk of atrial arrhythmias. QT dispersion (QTD) can be used to assess~     homogeneity of cardiac repolarization and may be a risk for ventricular arrhythmias.~      Aim: To search PWD and QTD in patients with psoriasis. Methods: Ninety-four outpatient~     psoriasis patients and 51 healthy people were evaluated by physical examination, 12-lead ECG~     and transthoracic echocardiography. Severity of the psoriasis was evaluated by psoriasis Area~     and Severity Index (PASI).~   "
116280|NCT02045472|"~     The purpose of this study is to assess the safety, tolerability, immunogenicity and~     pharmacokinetics of single escalating doses of VIS410 in healthy volunteers.~   "
116291|NCT02045329|"~     The normal bacteria that inhabit the human nose, also known as the nasal microbiome, may~     serve as a host defense mechanism against colonization and infection by Staphylococcus~     aureus, including methicillin resistant S. aureus (MRSA). Mupirocin is a topical~     antibacterial agent that may be used to clear nasal colonization with S. aureus, and reduce~     risk of S. aureus infection. The impact of mupirocin on the normal nasal microbiome is not~     known. We hypothesize that the nasal microbiome is changed by mupirocin. Our study aims to~     define the nasal microbiome before and after decolonization therapy with mupirocin.~   "
116292|NCT02045316|"~     The etiologic agent responsible for the development of preeclampsia remains unknown.~     Aquaporins, members of integral membrane proteins, are responsible of water molecules~     movements through the plasma membrane channels, energy metabolism and associated with changes~     in cellular volume during apoptosis.~      İn such placental pathology as preeclampsia, characterized with superficial implantation and~     increased apoptosis leading to a relative hypoxia between mother and fetus, the hypothesis of~     aquaporins important role in energy homeostasis and apoptosis maybe suggested.~   "
116281|NCT02045459|"~     For part of this study, we are collecting information from patients that have been~     experiencing the symptoms mentioned above. We are taking this information and creating a~     chest pain registry to follow trends and compare different patients having similar symptoms.~     We hope to gain insight into the quality of life, symptoms, and cardiac events of those who~     are having similar symptoms. The type of information we will collect includes: demographics,~     quality of life, levels of anxiety related to angina pain and cardiac events occurring within~     a 2 year period of time.~      In addition, we are performing a cardiac stress MRI for research purposes to look at the~     blood flow in the small vessels in your heart. During the stress cardiac MRI, we will give~     you a medication called Regadenoson (Lexiscan) which stresses your heart by dilating the~     blood vessels to your heart. This drug is approved by the U.S. Food and Drug Administration~     (FDA) for this purpose. We will then be able to measure the myocardial perfusion reserve~     (MPR) which is a measure of blood flow through the small blood vessels to see if an abnormal~     MPR and small blood vessel disease is associated with an increased risk of cardiovascular~     events, such as heart attack. At this point, there is no specific therapy for small vessel~     disease. In addition we have phase II of this study which is to determine if exercise and~     intensive medical therapy together compared to intensive medical therapy alone improves pain~     from the heart and improves overall quality of life.~   "
116282|NCT02045446|"~     The core hypothesis to be tested is that the use of consolidative SBRT followed by~     maintenance chemotherapy in patients with less than or equal to 6 metastatic sites (primary +~     5) will improve progression free survival (PFS) compared to maintenance chemotherapy alone.~   "
116283|NCT02045433|"~     The purpose of this study is to determine whether SABR boost therapy is effective in women~     with locally advanced cervical cancer without increased risk of acute gastrointestinal (GI)~     or genitourinary (GU) toxicity.~   "
116284|NCT02045420|"~     The purpose of this study is to use non-invasive Magnetic Resonance Imaging (MRI) scans to~     investigate venous insufficiency, brain iron levels and white matter hyperintensities (WMHs)~     to determine if there is direct correlation with Idiopathic Parkinson's Disease (IPD).~      Idiopathic Parkinson's disease (IPD) is the second most common neurodegenerative disease~     after Alzheimer's disease and it affects roughly 0.1% to 0.3% of the population. The risk of~     having IPD increases with age and the median onset age is about 60 years. The etiology of IPD~     remains unknown. Generally, Parkinson's patients show a reduction of dopamine levels in the~     deep grey matter of the brain over time. Many clinically diagnosed cases of IPD are~     associated with white matter hyperintensities (WMH) and elevated brain iron levels.~     Furthermore, in the last few years there has been an increasing interest in the role of veins~     in neurodegenerative diseases. More attention has been paid to the extracranial veins as~     being potential sources of venous hypertension. The obstructed veins are thought to cause~     venous insufficiency. By using MRI techniques, the investigators can not only obtain~     qualitative vascular information but also quantitative arterial and venous blood flow~     measurements.~   "
116285|NCT02045407|"~     The purpose of this study is to assess the reliability of computed tomography angiography~     (CTA) to diagnose brain death, face of several conditions that make impossible to define such~     diagnosis using clinical criteria exclusively.~   "
116286|NCT02045394|"~     Haemoptysis is the coughing up of blood originating from the respiratory tract. It is a~     common and worrying clinical symptom which can be due to different aetiologies including lung~     cancer, tuberculosis, COPD, bronchiectasis, pneumonia, acute bronchitis or unknown origin~     (cryptogenic haemoptysis). Epidemiology and optimal diagnostic approach are largely unclear.~     Aims of this study are to define current epidemiology and to provide the best diagnostic~     approach by providing a diagnostic algorithm.~   "
116287|NCT02045381|"~     Currently, appropriate patients undergo MRI imaging with immobilization and sequences~     optimized for diagnostic radiology purposes. Using a mutual information algorithm, these~     images are then registered to a treatment planning CT obtained with custom immobilization to~     minimize intra-and inter-treatment motion and positional variation. This image registration~     process is time-consuming and introduces additional layers of geometric uncertainty into what~     should be a highly precise treatment planning process. However, it is necessary, since~     radiation dose calculations cannot be performed on MRI data due to the lack of crucial~     density information. The investigator envisions CT-less treatment planning, using only MRI,~     due to superior imaging characteristics, fully integrated into the radiation oncology clinic.~     This study will begin this process.~   "
116288|NCT02045368|"~     This phase I dose escalation study will evaluate IGF-Methotrexate conjugate (765IGF-MTX) in~     patients with advanced, previously treated tumors. 765IGF-MTX is administered as an IV~     infusion over 1 hour on days 1, 8 and 15 of a 28 day cycle. Treatment continues until disease~     progression, unacceptable toxicity, or patient refusal. Assessment of response will be~     confirmed with imaging studies performed at the end of cycle 2 +/- 7 days, and every 2 weeks~     thereafter.~   "
116289|NCT02045355|"~     Health effects of fish consumption have been demonstrated in epidemiological studies and in~     controlled intervention studies in a number of different population groups, however,~     randomized controlled studies on the effect of fish consumption in elderly are sparse. Many~     studies have focused on n-3 fatty acids instead of fish as a food and therefore, many health~     effects have only been related to the effect of n- 3 fatty acids. The elderly are a~     heterogeneous population group and therefore difficult to study. In order to reduce~     heterogeneity, it is advisable to focus on elderly with specific needs. Elderly who~     experienced a hip fracture can serve as a model for an advanced ageing process, as these~     patients typically experience a huge inflammatory response, immobilisation and a reduction in~     muscle mass. Increased fish intake is believed to have effects towards inflammation and a~     reduction in muscle mass. Therefore, we want to test whether increased fish intake can have~     positive health effects in elderly who experienced a hip fracture.~      Main hypothesis:~      Increased fish intake (salmon, cod, pelagic fish), in comparison to meat, will increase~     mobility, muscle strength and mobility in frail elderly.~      Objectives~        1. To evaluate the health effects of fish consumption in frail elderly The effect of a~          dietary intervention with fish on mobility, muscle mass and strength in elderly who~          experienced a hip fracture has not been shown before.~        2. To demonstrate the feasibility of dietary intervention in elderly We want to show that a~          dietary intervention with fish or control meals is feasible in elderly. The meals (4~          portions of fish per week or control portions of meat) will be delivered to their homes.~      Description of work and role of participants This is a randomized clinical trial (RCT) on the~     effect of fish consumption on mobility in elderly who experienced a hip fracture. Elderly who~     experienced a hip fracture but were able to walk without support by a person before the~     fracture, will receive, after being randomized to two groups, fish or meat to be used in cold~     or warm meals at 4 days per week for a period of 16 weeks. Measurements will be taken at~     baseline (when patients have left the rehabilitation center), after 4 weeks and after 16~     weeks. Measurements at 4 and 16 weeks after inclusion will be at their homes or in the~     outpatient clinic.~   "
116293|NCT02045303|"~     Wound healing rate is higher when contact ultrasound therapy is followed by noncontact~     ultrasound therapy on sub-acute and chronic lower extremity ulcers of various etiologies~     requiring selective debridement, as compared to either Sonoca-180 or MIST Therapy alone.~   "
116294|NCT02045290|"~     Insulin Clamp Ancillary study for Assessment of Insulin Resistance will be conducted as a~     sub-study to the main protocol, Metformin Therapy for Overweight Adolescents With Type 1~     Diabetes (NCT01881828). The purpose of this ancillary study is to assess if metformin will~     improve tissue-specific insulin resistance (IR) in type 1 diabetes using a hyperinsulinemic~     euglycemic clamp; a 3-month randomized trial comparing metformin versus placebo in 12 to <20~     year olds with BMI >85th percentile ( total daily insulin dose >0.7 units/kg, and HbA1c~     7.0%-9.9%).~   "
116295|NCT02045277|"~     The objective of the study is to evaluate the safety and efficacy of a topical lotion~   "
116296|NCT02045264|"~     This is a single-dose study to evaluate the pharmacokinetics, safety, and tolerability of~     icatibant administered to adult Japanese subjects.~   "
116297|NCT02045251|"~     Over the years, it has become clear that the first-line triple therapy is losing efficacy~     worldwide. A capsule containing 3 agents (Pylera®) containing 125mg metronidazole, 140mg~     bismuth subcitrate potassium, and 125mg tetracycline was made available.~      The efficacy of the Pylera capsule was studied in a randomized control trial, in which a~     quadruple Pylera therapy (Pylera capsule and a PPI) was evaluated against the standard triple~     regimen. In the study, 3 three-in-one capsules were taken four times daily (after meals and~     at bedtime).~      Given the above, we aim at assessing the effectiveness of fewer pills per day of the Pylera~     capsule (3 Pylera capsules supplemented with the addition of amoxicillin and esomeprazole~     twice daily; sum of 10 pills/day for 10 days) in the eradication of H. pylori.~   "
116298|NCT02045238|"~     Acute viral bronchiolitis is an extremely common childhood disease, responsible for~     approximately 17% of childhood admissions to hospital per year, with an annually cost that~     reaches U$ 500 million.~      Despite being a well known disease among pediatricians, there are few, if any, effective~     treatment options apart from oxygen supplementation and adequate hydration.~      The purpose of this study is to determine wether nebulized hypertonic saline (3%) is more~     effective than normal saline (0,9%) when used in repeated doses during the first 24 hours of~     in-hospital treatment.~   "
116299|NCT02045225|"~     Men who have sex with men (MSM) bear a disproportionate burden of the Human Immunodeficiency~     Virus (HIV) epidemic in Canada, and HIV incidence appears to be rising among Canadian MSM~     (1). MSM comprised nearly half (44.1%) of new positive HIV tests in 2009 (2). Among MSM in~     Ontario, from 2001 to 2006, HIV diagnoses increased 26% (3). Given the alarmingly high HIV~     prevalence rates among MSM in North American cities, there is a critical need for HIV~     prevention interventions for MSM in Canada. Social anxiety, or anxiety about being evaluated~     in interpersonal situations, is a reliable risk factor for unprotected anal intercourse (UAI)~     among MSM (4 and 5). Social anxiety is highly modifiable via cognitive-behavioural therapy, a~     form of psychotherapy (6). Social anxiety may also increase substance use in sexual~     situations, which is another risk factor for HIV among MSM (7 and 8). As such, an~     empirically-based social anxiety treatment may also reduce HIV risk behaviours among MSM. The~     present study will provide Phase I trial data for a novel and innovative HIV prevention~     intervention for MSM. This is a proposal to test a novel integrated HIV prevention~     intervention that combines empirically supported treatments for social anxiety with HIV risk~     reduction counseling to reduce HIV sexual risk behaviour.~   "
116300|NCT02045212|"~     The study objectives are to assess any changes in visual acuity and visual field observed~     following the administration of RPh201 during an overall treatment period of at least 13~     consecutive weeks with an option to extended the treatment phase to another 13 weeks (26~     weeks total), and at the follow-up visit at 3 month after end of treatment in patients with~     optic nerve neuropathy.~   "
116301|NCT02045199|"~     The purpose of this study is to evaluate the efficacy and the safety of the cream V0111 in~     the treatment of fissure(s) situated on the heels in diabetic patients with polyneuropathy.~   "
116302|NCT02045186|"~     The purpose of this research study is to determine whether and when patients with human~     papilloma virus positive squamous cell cancer of the oropharynx treated with radiation and~     chemotherapy clear their human papilloma virus infection.~   "
116303|NCT02045173|"~     The purpose of the study is to compare, three months after implantable~     cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D),~     the apnea-hypopnea index (AHI) obtained from conventional in-lab NPSG/NPG (AHIPSG) with~     similar indices obtained from autoscoring algorithms of the ApneaScan™, an implantable~     impedance-based respiration sensor (AHIAS).~   "
116304|NCT02045160|"~     In this study, we aim to investigate the incidence of the adverse reactions, the~     effectiveness and the gene polymorphism associated with the plasma level of~     sulfamethoxazole-trimethoprim and their metabolites (including N4-acetyl-sulfamethoxazole,~     sulfamethoxazole hydroxylamine and sulfamethoxazole-nitroso). And we also aim to investigate~     the factors associated with the sulfamethoxazole-trimethoprim induced acute psychosis.~   "
116305|NCT02045147|"~     There is overwhelming evidence that patients with multiple chronic illnesses need better~     self-management skills. Discharge from the hospital may not be the most opportune time to be~     teaching patients these self-management skills. There are several different care transition~     models being used across the country; however we know that not every patient needs the same~     type or amount of an intervention. The purpose of this pilot study is to examine the effects~     of delivering a home based care transitions intervention (HBCTI) with four different groups~     tailored on cognition and level of patient activation compared to usual care (UC) on the~     outcomes of health care utilization (HCU) and health outcomes: patient-reported health~     status, assessment of care for chronic conditions, and quality of life in adult patients with~     multiple chronic diseases dismissed to home from an acute care facility. Our working~     hypothesis is that patients in the HBCTI groups compared to the UC group will have lower HCU~     and improved outcomes (patient-reported health status, assessment of care for chronic~     conditions, and quality of life).~   "
116361|NCT02044419|"~     To compare the relative bioavailability of lomitapide when administered by sprinkling the~     contents of a 20 mg capsule of lomitapide in applesauce or in mashed banana to a single oral~     intact capsule dose of 20 mg lomitapide in healthy subjects.~   "
116362|NCT02044406|"~     To investigate the safety, tolerability, pharmacokinetics (including dose proportionality~     assessment), and pharmacodynamics of single rising oral doses of BI 1181181 (Single rising~     dose (SRD) part) Secondly, to investigate the relative bioavailability of the tablet versus~     the powder for oral solution (PfOS) and the effect of food on the pharmacokinetics of BI~     1181181 (Bioavailability/Food effect (BA/FE) part)~   "
116306|NCT02045134|"~     Post-operative atrial fibrillation (POAF) is a major cause of morbidity and mortality after a~     cardiac surgery. Both systemic inflammation and oxidative stress play a role in the~     initiation of POAF after a cardiac surgery. Epidemiological studies show a significant~     inverse correlation between cardiovascular risk and consumption of polyphenol-rich foods~     (PRFs), due to antioxidant, vasorelaxant and antithrombotic properties of their polyphenolic~     components. The main objective of this study is to evaluate the effect of polyphenol-rich~     food supplementation on post-operative atrial fibrillation (POAF) in patients undergoing an~     open heart surgery (mainly coronary artery bypass grafts (CABG) and valve replacement or~     repaired (VR))~   "
116307|NCT02045121|"~     Malignant pleural effusion (MPE) accounts for 50% of all pleural effusions and affects about~     300,000 patients annually (UK and USA). Lung and breast cancers account for majority of~     malignant pleural effusions; 1 in 3 breast cancer, 1 in 4 lung cancer as well as > 90% of~     patients with mesothelioma develop pleural effusions. Breathlessness from MPE is disabling~     and impairs quality of life. Median survival ranges between 4-6 months. Although~     thoracentesis provides effective symptom relief, most effusions recur and pleurodesis is the~     standard of care. Pleurodesis can be performed via chest tube or applied during pleuroscopy,~     and talc is the most effective agent. For successful pleurodesis to occur the underlying lung~     must expand after fluid drainage and trapped lung due to metastatic disease occurs up to 30%.~     Symptomatic patients require hospitalization for these procedures which are likely to fail if~     trapped lungs are encountered, and pose significant burden to health services. Tunneled~     indwelling pleural catheter (IPC) is emerging as a viable alternative which provides access~     to the pleural space for fluid drainage when breathlessness arise. IPC can be performed at~     ambulatory setting without hospital admission. Case series have demonstrated long-term safety~     of IPC even in patients undergoing chemotherapy with acceptable complication rates. By~     keeping the pleural cavity free of fluid, IPC has led to spontaneous pleurodesis in 50% of~     patients, which allows its removal. Presently IPC is indicated for trapped lung or when talc~     pleurodesis has failed. A randomised comparative trial with talc pleurodesis is necessary to~     determine role of IPC as first-line therapy of MPE, if IPC leads to reduction in~     hospitalizations, adverse events and healthcare costs, and if it improves quality of life.~     The multicenter trial randomizes symptomatic patients 1:1 to IPC or talc pleurodesis, and~     endpoints include hospitalization days till death or end of study, adverse events, quality of~     life, and healthcare costs.~   "
116308|NCT02045108|"~     The overarching goal of this study is to determine whether combined cognitive training and~     Transcranial Direct Current Stimulation (tDCS) reduces drinking in high-risk drinkers. To~     this end, specific study purposes are: 1) replicate previous findings that cognitive~     retraining reduces drinking levels, 2) test whether cognitive retraining can be enhanced with~     tDCS, and 3) investigate the neural changes that result from cognitive retraining and tDCS.~     We hypothesize that those participants who receive alcohol avoidance cognitive training will~     have greater reductions in drinking. In turn, those participants who receive a higher level~     of applied tDCS during alcohol avoidance response training will have better avoidance~     learning, as well as, a larger reduction in drinking behavior. Finally, those participants~     receiving a higher level of applied tDCS will have more neuronal response associated with~     alcohol avoidance during the brain imaging session.~   "
116309|NCT02045095|"~     This is an open-label, multicenter, phase 1, dose escalation study with expansion cohorts~     that will evaluate the safety (establish the MTD and inform the RP2D), tolerability, PK,~     pharmacodynamics, and antitumor activity of MLN7243 in patients with advanced malignant solid~     tumors.~   "
116310|NCT02045082|"~     The purpose of this study is to compare a corneal sampling realized by a flocked swab~     (flocked swab regular 519CS01) with a sampling by traditional fiber swab (Copan regular swab~     164KS01 in polyester). Their impact on the sensibility of the viral culture in the Herpes~     simplex epithelial keratitis will be the primary objective of this study.~   "
116311|NCT02045069|"~     This is a Phase II/III, Randomized, Double-Blind, Placebo-Controlled Study of Efficacy and~     Safety of Ivermectin in Children and Adult patients with Dengue Infection.~   "
116312|NCT02045056|"~     The purpose of this study is to assess the safety and efficacy of gemfibrozil in modulating~     microRNA-107 levels for the prevention of Alzheimer's disease in subjects with intact~     cognition and mild cognitive impairment~   "
116313|NCT02045043|"~     Arrhythmias remain a major health problem, causing at least 250,000 deaths annually in the~     United States. Pharmacological treatments often do more harm than good, and device therapies~     are limited by high cost and effects on quality of life. Ion channel mutations cause rare~     inherited arrhythmopathies, but account for only a small fraction of patients with life-~     threatening arrhythmias and sudden death. Most arrhythmias occur during myocardial ischemia,~     following myocardial infarction, and in patients with poor left ventricular (LV) function of~     any etiology. Aside from ejection fraction (EF), few clinically useful indicators to stratify~     the risk of sudden death have been identified. The role of subtle difference in ion channel~     expression and/or structure in predisposing patients to arrhythmias and modulating the risk~     of sudden death is unknown.~      In this study, we are prospectively testing whether polymorphisms in ion channels and ion~     channel modifying genes are associated with arrhythmias in a population with internal~     cardioverter-defibrillators (ICDs) and poor LV function. We will test the hypothesis that~     functional polymorphisms in the coding sequences and promoter regions of cardiac genes (e.g.~     ion channels, beta-adrenergic receptors) predispose individuals to arrhythmias and /or heart~     failure progression.~      We hope to identify genetic predictors for the common forms of sudden cardiac death. This~     would allow the identification of a subpopulation of heart failure patients that would~     benefit most from ICD placement.~   "
116314|NCT02045030|"~     This is a Phase II multi-center exploratory study to identify biomarkers predictive of~     clinical response to aflibercept in patients with metastatic colorectal cancer who have~     failed first-line therapy, consisting of an oxaliplatin-containing regimen in combination~     with bevacizumab. Patients will consent to a needle core biopsy of a liver metastatic lesion~     prior to starting treatment and blood samples will be collected from study patients during~     treatment.~      An exploratory pharmacoeconomic analysis will be performed to evaluate productivity loss,~     quality of life and resource utilization while on treatment with aflibercept.~   "
116315|NCT02045017|"~     The primary purpose of the study is to determine the safety and efficacy and to generate PK~     and biomarker data for the combination of Pomalidomide and low-dose Dexamethasone in patients~     with relapsed or refractory multiple myeloma, with moderate or severe renal impairment.~   "
116363|NCT02044393|"~     Investigation of the relative bioavailability of a single dose of BI 691751 when given alone~     and together with itraconazole; safety and tolerability~   "
116364|NCT02044380|"~     The main aim of this study is to evaluate the safety and tolerability of afatinib in patients~     with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring Epidermal~     Growth Factor Receptor (EGFR) mutation(s) and have never been treated with an EGFR-Tyrosine~     Kinase Inhibitor (TKI)~   "
116316|NCT02045004|"~     Despite an ongoing controversy in the scientific literature, the link between anesthesia and~     dementia and/or cerebral atrophy remains unclear. Recent retrospective data suggests an~     association of surgery with a reduction in brain volume. With the present prospective cohort~     study, we would like to reproduce and verify these results, and investigate a possible~     association with the postoperative cognitive performance.~      We will measure cerebral gray matter volumes in elderly patients before, 3 and 12 months~     after major non-cardiac surgery and determine cognitive functions at the same time.~      Study hypothesis:~        1. Surgery under general anesthesia in elderly patients is associated with a loss of gray~          matter.~        2. The degree of cognitive dysfunction is associated with the loss of grey matter in brain~          areas relevant for cognitive functions.~   "
116317|NCT02044991|"~     The purpose of this study is to see if pelvic girdle pain can be more effectively treated~     with the use of injectable anti-inflammatory medication plus physical therapy compared with~     physical therapy and a saline injection.~   "
116318|NCT02044978|"~     16 patients will be included. Each patient receives 2 dental implants. One of them is coated~     with a drug, zoledronate, to improve fixation. Fixation is measured by vibration resonance~     frequency analysis at insertion and 2, 4, 6 and 8 weeks after insertion.The 2 implants in~     each patient are compared. We expect to find an early improvement (higher resonance~     frequency) in the coated implant.~   "
116319|NCT02044965|"~     Although clean intermittent catheterization (CIC) remains the mainstay to ensure complete~     low-pressure bladder emptying in neurogenic bladder (NB) patients, this forms a vehicle for~     bacterial entry and colonization of the urinary tract, which can lead to recurrent urinary~     tract infection (RUTI) and renal damage. Up to 25% of NB patients on CIC suffer from RUTI and~     daily, low-dose antibiotic prophylaxis is widely prescribed to prevent these infections.~     Unfortunately, this therapeutic option is not evidence-based and can be associated with a~     higher risk of RUTI secondary to development of antibiotic resistance. In addition, many~     children suffer from a range of adverse reactions and emergence of drug resistant organisms.~     Moreover, recent studies have shown that antibiotics cause a major disruption in the human~     microbiome, potentially leading to long term major problems.~      Probiotics are live microorganisms, which when administered in adequate amounts confer a~     health benefit on the host. There is evidence that probiotics restore microbial homeostasis~     in the vagina, reduce the risk of pathogen ascension into the bladder, and modulate immunity~     to better protect the host. Probiotic strains, including Lactobacillus rhamnosus GR-1,~     Lactobacillus reuteri B-54 and RC-14, have been shown to be safe and efficacious in an oral~     formulation or as a vaginal suppository in improving the microbiota profile of the vagina and~     decreasing the risk of RUTI. Various mechanisms appear to be involved, including modulating~     antimicrobial and inflammatory defenses, up-regulating protective mucin production and~     reducing the pressure on pathogens to acquire antibiotic resistance genes. A randomized trial~     comparing probiotics to antibiotic prophylaxis in children with vesicoureteric reflux showed~     equivalent reduction in the incidence of RUTI and development of new renal scarring. In~     addition, down regulation of inflammatory cytokines can potentially favorably alter bladder~     function and prevent bladder fibrosis.~      Investigators at London Health Sciences Centre (LHSC) have the opportunity to acquire~     clinical data that would strengthen the case for probiotics to be integrated into pediatric~     urology practice for managing CIC and RUTI. This would be the first such study in pediatric~     NB patients.~      The main objective of this study is to determine whether the use of probiotics (lactobacilli)~     can decrease the impact of adverse side effects and the antibiotic resistance that is seen~     with the prolonged use of antibiotics for patients with neurogenic bladder conditions.~   "
116320|NCT02044952|"~     The purpose of this study is to assess the effect and safety of Tripterygium Glycosides in~     the treatment of Crohn's disease for induction remission and compare the therapeutic effect~     with patients who received mesalazine.~   "
116321|NCT02044939|"~     The primary objective of the study is to assess the improvement of daily activity in subjects~     with Stage IV Pulmonary Sarcoidosis one year after the conduct of a pulmonary rehabilitation~     program.~      The secondary objectives are the following:~        -  assess the improvement of daily activity at several times : 2, 6 and 12 months after the~          beginning of a pulmonary rehabilitation program~        -  assess the improvement of exercise capacity by tests used in medical practice~        -  assess the correlation between daily activity and exercise capacity~        -  assess the improvement of dyspnea~        -  assess the improvement of quality of life and psychological state~   "
116322|NCT02044926|"~     Purpose:~      To investigate diagnostic performance of CT and MR in intraductal papillary mucinous neoplasm~     with malignant change according to international consensus guidelines 2012.~      Hypothesis: According to 2012 consensus guidelines, enhanced solid component and main~     pancreatic duct size of larger than 10 mm will be significant.~   "
116323|NCT02044913|"~     The primary objective of this study is to test in a randomized controlled trial if~     aftercare-coordination by phone subsequent to inpatient treatment is an effective aftercare~     approach in the treatment of depression and anxiety.~   "
116324|NCT02044900|"~     The purpose of this study is to evaluate the diagnostic accuracy of polysomnography indexes~     for diagnosis of sleep apnea in human subjects obstructive sleep apnea (OSA). This includes~     evaluation of polysomnography indexes (AHI; AI, arousal index; ODI, oxygen desaturation~     index) and heart rate variability (HRV) indexes.~   "
116325|NCT02044887|"~     Objective: To assess the effectiveness of an intervention in Primary Health Care to increase~     the physical activity (PA) and improve cognitive state and cardiovascular risk in patients~     with dementia and their relative caregivers.~      The results can be used to improve the technical characteristics of the devices that record~     the physical activity of patients with dementia make marketing easier~   "
116326|NCT02044874|"~     In smokers who are motivated to stop smoking, treatment with lorcaserin compared with placebo~     will provide greater abstinence as measured by the last 4 weeks of treatment (Weeks 9-12)~   "
116327|NCT02044861|"~     ACT-PFK-158 is a novel anti-cancer agent that inhibits glucose uptake in cancer cells. The~     primary objective of the study will be to determine the maximum tolerated dose (MTD) and to~     describe any dose limiting toxicity. The secondary objectives of the study will be to~     determine the safety profile of the drug, to determine the pharmacokinetic profile, to~     identify any anti-tumor activity, and to determine the pharmacodynamic profile of~     ACT-PFK-158.~   "
116328|NCT02044848|"~     This study will assess the safety and efficacy of secukinumab on the preservation of~     pancreatic beta cells in patients with newly-diagnosed type 1 diabetes mellitus.~   "
116365|NCT02044367|"~     To investigate the relative bioavailability of dabigatran etexilate as pellets on food and of~     dabigatran etexilate as granules resolved in reconstitution solution, each with dabigatran~     etexilate as capsule following oral administration. To evaluate acceptability and~     palatability of Pellets sprinkled on food and Oral Liquid Formulation~   "
117159|NCT02033993|"~     The purpose of this study is to compare the effects on urothelial cancer of nab-paclitaxel~     compared to paclitaxel to treat this disease.~      This research is being done because currently there is no effective treatment for urothelial~     cancer that has progressed after prior chemotherapy.~   "
116329|NCT02044835|"~     • Background: Since evidence show that renal-artery stenting did not confer a significant~     benefit with respect to the prevention of clinical events when added to comprehensive,~     multifactorial medical therapy in people with atherosclerotic renal-artery stenosis[1], the~     aim of our study was to confirm Fu-zheng-qu-zhuo (FZQZc) oral liquid, a herbal medicine,~     combined with optimal medical therapy of internal medicine (OMT), including anti-platelet~     therapy and other protocol-driven medical therapies to control blood pressure and glucose and~     lipid levels in accordance with guidelines,resulted in greater renal function protection in~     patients with atherosclerotic renal artery stenosis ( ARAS) compared with OMT alone.~      Methods : A randomized, placebo-controlled, single centre clinical design. Sixty patients~     with diagnosed atherosclerotic renal artery stenosis and had chronic kidney disease stage 3~     will be recruited, and will be randomized into two groups in a 1:1 ratio ( FZQZ and placebo~     Group, 30 respectively). FZQZ Oral liquid or placebo 20 ml every time, three times a day for~     different groups, meanwhile, all participants in both treatment groups received OMT, 6 months~     therapeutic period. Serum creatinine, estimated glomerular filtration rate(eGFR), urine~     protein, and cardiovascular and renal events (a composite end point of death from~     cardiovascular or renal causes, myocardial infarction, stroke, hospitalization for congestive~     heart failure, progressive renal insufficiency, or the need for renal-replacement therapy)~     will be compared between the Groups as the outcome.~   "
116330|NCT02044822|"~     The primary objective of this study is to evaluate overall response rate (ORR) following~     treatment with idelalisib plus rituximab in participants with previously untreated chronic~     lymphocytic leukemia (CLL) with 17p deletion.~      An increased rate of deaths and serious adverse events (SAEs) among participants with~     front-line CLL and early-line indolent non-Hodgkin lymphoma (iNHL) treated with idelalisib in~     combination with standard therapies was observed by the independent data monitoring committee~     (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data~     and terminated those studies in agreement with the DMC recommendation and in consultation~     with the US Food and Drug Administration (FDA). All front-line studies of idelalisib,~     including this study, were also terminated.~   "
116331|NCT02044809|"~     The purpose of this trial is to investigate a novel treatment for cannabis dependence:~     cannabidiol. Between 96 and 168 young people who want to quit cannabis and meet criteria for~     moderate cannabis use disorder (DSM-5) will be recruited from the community. Stage one aims~     to identify the Most Effective Dose (MEDmg) of oral cannabidiol for reducing cannabis use~     over four treatment weeks. Stage two will determine whether the MED identified in stage 1 can~     offer an effective treatment for cannabis dependence.~   "
116332|NCT02044796|"~     This phase I/II trial studies the side effects and best dose of mitoxantrone hydrochloride~     when given together with filgrastim, cladribine, and cytarabine and to see how well they work~     in treating patients with acute myeloid leukemia or high-risk myelodysplastic syndromes that~     is newly diagnosed, has returned, or does not respond to treatment. Drugs used in~     chemotherapy, such as filgrastim, cladribine, cytarabine, and mitoxantrone hydrochloride,~     work in different ways to stop the growth of cancer cells, either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading.~   "
116333|NCT02044783|"~     Sedentary older adults are more likely to develop physical function impairments than active~     older adults. Physical function measured by slow usual gait speed predicts the risk of future~     falls, disability, institutionalization and mortality. Behavioral physical activity~     interventions have improved physical activity and physical function, but have not generally~     been implemented where they may have the most impact -- primary care settings. In part, this~     is due to the limited time and training for clinical staff to screen for physical function~     impairment and to treat with physical activity counseling. The proposed scientific goal is to~     overcome these barriers by adapting an evidence-based screening tool and telephone-based~     physical activity intervention into primary care settings.~      Aim1: Among older adults who screen positive for physical function impairment, to determine~     the estimated intervention effect size of a 12-week behavioral intervention on physical~     activity and physical function.~      Hypothesis 1a: Physical activity levels will increase more in the intervention vs. usual care~     group.~      Hypothesis 1b: Physical function will increase more in the intervention vs. usual care group.~      Aim 2: Among Aim 1 participants and clinical staff who deliver the functional screening and~     Aim 1 intervention, to evaluate standard implementation science process metrics of reach,~     acceptability, and implementation~   "
116334|NCT02044770|"~     The primary objective of this clinical study is to describe the initial clinical experience~     with ENSEAL® G2 Articulating Tissue Sealer in laparoscopic colectomy, quantifying and/or~     qualifying how its articulation feature enables optimization of vessel sealing through~     improved access, approach, and visibility. This is an observational study of device usage~     being conducted to report initial experience with the ENSEAL ART device. It is not intended~     as hypothesis testing.~   "
116335|NCT02044757|"~     The purpose of this study to investigate the addictive properties of soda and other sugar~     sweetened beverages (SBBs) in teenagers aged 13-18 years. It is hypothesized that~     participants who were regularly consuming sweetened and caffeinated beverages will experience~     symptoms typical of caffeine withdrawal, such as headache and fatigue, during the SSB~     withdrawal period.~   "
116336|NCT02044744|"~     The purpose of this study is to determine the impact of primary care referrals to community~     physical activity programs for overweight and obese youth aged 6-18 years on objectively~     measured physical activity and cardiorespiratory fitness, as well as other cardiovascular~     health indicators. We hypothesize that physical activity referrals will result in higher~     levels of physical activity and fitness.~   "
116337|NCT02044731|"~     The purpose of this study is to evaluate the impact on body mass index (BMI) of a 5-session~     childhood obesity intervention for African American families among children aged 5-12 years.~     We hypothesize that children participating in the program will experience a reduction in BMI.~   "
116397|NCT02043951|"~     The registry will enroll patients with claudication or critical limb ischemia and~     angiographically significant lesion(s) in arteries of the lower extremity. Subjects will be~     treated with the Lutonix® Drug Coated Balloon Catheter for approved indications according to~     the current country-specific Instructions for Use (IFU) and followed clinically for 1 year.~   "
116338|NCT02044718|"~     An adverse event (AE) is defined as unintended injury or complication, which results in~     disability, death or prolongation of hospital stay, and is caused by healthcare management~     (including omissions) rather than the patient's disease. Retrospective record reviews in~     several countries have shown that 2,9% to 16,6% of patients in acute hospitals experience one~     or more AEs. A patient with an AE may require a higher level of care. Although all AEs are~     important, preventable AEs that result in an upgraded level of patient care are of particular~     concern. In this study it's defined as an unplanned admission to intensive care unit (ICU) or~     a Mobile Emergency Team (MET) intervention. The objectives of this study are to determine the~     incidence of (preventable) adverse events requiring ICU admission or MET intervention and to~     assess the level of harm of each AE.~   "
116339|NCT02044705|"~     The purpose of this study is to evaluate the impact of the 10-week Active and Healthy~     Families (AHF) intervention on body mass index (BMI) in Latino youth aged 5-12 years.~   "
116340|NCT02044692|"~     The objective of this study is to evaluate the long term safety and efficacy of once weekly~     dosing of idurasulfase-beta 0.5mg/kg administered in Hunter Syndrome(Mucopolysaccharidosis~     II) Patients~   "
116341|NCT02044679|"~     Evaluate urine osmolality as a marker of fluid intake, in healthy subjects displaying a wide~     range of fluid intake behaviors~   "
116342|NCT02044666|"~     This study is intended to collect safety and effectiveness data on the Cook Micronized Small~     Intestinal Submucosa (SIS)~   "
116343|NCT02044653|"~     The primary objective of study is~        -  Part A : To explore the optimal fixed starting dose and dosing interval of GX-E2~        -  Part B : To evaluate the proof of concept (POC) of GX-E2~   "
116344|NCT02044640|"~     This is a retrospective chart review meant to identify any factors that are correlated with~     and may possibly lead to postoperative nausea and vomiting in order to predict need for~     longer hospital stays and potentially decrease postoperative nausea and vomiting.~   "
116345|NCT02044627|"~     This Phase 1 study will assess the mass balance recover of carbon-14 (14C) labelled ETC-1002~     and the routes and rates of excretion of [14C]-ETC-1002~   "
116346|NCT02044614|"~     1. To assess the feasibility and safety of applying a 12-week course of adjuvant~          low-frequency icodextrin-based peritoneal dialysis to an ongoing regimen of~          thrice-weekly in-center hemodialysis.~           Hypothesis: Icodextrin-based peritoneal dialysis can be safely and feasibly implemented~          in the context of ongoing thrice-weekly in-center hemodialysis.~        2. To measure the effects of a 12-week course of adjuvant low-frequency icodextrin-based~          peritoneal dialysis to ongoing thrice-weekly maintenance hemodialysis on:~          inter-hemodialytic weight gain, achievable hemodialytic dry weight, total body water,~          ambulatory blood pressure, serum phosphorus, and pre-to-post hemodialysis changes in~          serum potassium and pH, and Kidney Disease Quality of Life-SF physical functioning,~          energy fatigue, and general health scores.~      Hypotheses: Addition of adjuvant icodextrin-based peritoneal dialysis will:~        1. reduce inter-hemodialytic weight gain*~        2. enable achievement of lower hemodialytic dry weight~        3. reduce total body water~        4. improve ambulatory blood pressure control~        5. reduce serum phosphorus~        6. minimize per-hemodialytic changes in serum potassium and pH~        7. have favorable effects on indices of physical function and global health~             -  Indicates co-primary outcomes.~   "
116347|NCT02044601|"~     The goal of the Phase I part of this clinical research study is to find the highest tolerable~     dose of onartuzumab that can be given with erlotinib and standard chemoradiation (paclitaxel~     and carboplatin) to patients with NSCLC.~      The goal of Phase II is to learn if onartuzumab plus erlotinib and chemoradiation can help to~     control NSCLC. The safety of this drug will also be studied.~   "
116348|NCT02044588|"~     To determine the safety of using kidney organ from hepatitis B surface antigen positive~     donor, the author conducted the single-center, prospective study of the use of these kidneys~     for recipients who have protective level of hepatitis B surface antibodies.~   "
116349|NCT02044575|"~     Despite large efforts trying to improve diagnostic and therapy of sepsis have been made over~     the last decade (e.g. initiation of the Surviving Sepsis Campaign, defining evidence based~     sepsis therapy bundles) the mortality of septic shock remains high and causes high~     socioeconomical burden of disease.~      The purpose of this pilot study is to evaluate the design and conduct of a projected full~     scale clinical trial.~   "
116350|NCT02044562|"~     The purpose of this study is to evaluate whether dietary nitrate supplementation could~     improve the plasma nitrate levels for nasopharyngeal carcinoma patients receiving concurrent~     chemo-radiation therapy.~   "
116351|NCT02044549|"~     to compare effectiveness and tolerability of carbetocin versus syntometrine in prevention of~     Postpartum hemorrhage after cesarean section~   "
116352|NCT02044536|"~     The optimal number of biopsy and the detection rate of neoplastic lesions are not~     established. The aim of this study is to assess the current practice pattern and effect of~     training in upper endoscopic biopsy.~   "
116353|NCT02044523|"~     Liver fibrosis is an important public health problem, with a substantial morbidity and~     mortality due to progression to cirrhosis and hepatocellular carcinoma. All causes of chronic~     liver disease may lead to fibrosis. The traditional diagnostic approach requires a biopsy for~     assessing the severity of liver disease prior to therapy.~      However, liver biopsy has several limitations: cost, sampling error, and procedure-related~     morbidity and mortality. Considering the high prevalence of viral hepatitis and nonalcoholic~     fatty liver disease, a condition often associated with obesity and type 2 diabetes, there is~     an urgent need for noninvasive screening, diagnosis and monitoring strategies of chronic~     liver disease severity.~      Our team has the expertise to investigate ultrasound-based and magnetic resonance-based~     elastographic methods for the noninvasive staging of liver fibrosis.~      The primary objective of this cross-sectional study is to compare the sensitivity of~     elastographic methods for detecting histology-determined significant fibrosis.~      The secondary objectives are to compare the diagnostic accuracy of these elastographic~     methods and the influence of potential confounders (inflammation, steatosis and iron~     deposition) on their diagnostic accuracy.~   "
116398|NCT02043938|"~     This is an interventional, randomized controlled study in health volunteers that involves~     collecting data on raw EEG waves measuring various combinations of anesthetic drugs during~     standardized drug titration.~   "
116354|NCT02044510|"~     The proposed study is a randomized, double blind placebo controlled multicenter study to~     determine the effectiveness of mirabegron in the treatment of neurogenic bladder dysfunction.~     Patients will be randomized into one of two trial arms: mirabegron 25mg for two weeks, with~     escalation to 50mg for the remaining 8 weeks, or matched placebo capsule for two weeks, with~     placebo escalation for the remaining 8 weeks. Each of these trial arms will be stratified~     based on whether the patient is already taking an anticholinergic medication or not. The~     study will treat a total of 144 patients (72 with placebo, 72 with mirabegron). The study~     hypothesis is that mirabegron will result in a statistically superior (increased) urodynamic~     bladder capacity.~      The study duration is 12 weeks, with a 1-4 week run in period where no active or placebo~     treatment will be administered. The primary outcome measure will be based on an increase in~     urodynamic bladder capacity. Secondary outcome measures will be additional urodynamic~     parameters, urinary symptom scales, urinary quality of life indices, and voiding diary~     results.~      Patients who are over 18 years of age with a diagnosis of multiple sclerosis or spinal cord~     injury will be eligible to participate. All eligible patients will have urodynamic studies~     performed within 4 weeks of trial enrollment, and at the end of study (week 9-10). Adverse~     events and study outcomes will be assessed at predefined study time points.~   "
116355|NCT02044497|"~     Oxycodone is an oral opioid analgesic that is most commonly prescribed for the management of~     pain in post-operative patients at Boston Children's Hospital. Oxycodone has been widely used~     in adults and children to relieve post-operative pain. However, its pharmacokinetics (what it~     does in the body) and pharmacodynamics (how it works) have not been well established in~     children. Some children, because of their specific genetic make-up, may metabolize the drug~     more quickly and therefore may be at risk for more side effects in the commonly prescribed~     dose. We would like to find out more about how this drug is absorbed, metabolized and~     excreted in children. In order to study these aspects, we would like to give oxycodone to~     surgical patients at Boston Children's Hospital then measure its metabolic activity and also~     perform a genetic analysis. The genetic testing is specifically to analyze the following~     genotypes only: cytochrome P450 2D6 (CYP2D6) and cytochrome P450 3A4 (CYP3A4), which~     represent the differences in cytochrome P450 metabolism of oxycodone.~   "
116356|NCT02044484|"~     This research, co-sponsored by the Centers for Disease Control and Prevention and the~     National Institute of Mental health, is conducted at six HIV clinics in the U.S. The research~     examines the effect of a clinic-based multi-component intervention delivered to HIV patients~     when they attend clinic for primary care. The study tests the hypothesis that the~     intervention will improve the viral load status of patients and improve attendance for HIV~     primary care.~   "
116357|NCT02044471|"~     Continuous-flow (CF) left ventricular assist devices (LVADs) are an important tool in the~     treatment of end-stage heart failure, affording patients significantly improved quantity and~     quality of life. In recent years, tens of thousands of LVADs have been implanted worldwide,~     with nearly 1,000 at the Texas Heart Institute (THI). Despite the benefits from LVAD therapy,~     one major weakness is the high frequency of late strokes, reported up to 19%. CF LVADs~     minimize or remove the pulsatility within the blood system, introducing a new and~     incompletely understood physiology.~      Increased sympathetic (fight or flight nervous system) tone secondary to lack of pulse in~     the blood system can cause high blood pressure, with subsequent hemorrhaging strokes~     (bleeding into the brain) are one possible explanation for this high adverse event rate in CF~     LVAD patients. A simple intervention to decrease the increased sympathetic tone is called~     ischemic conditioning; a sphygmomanometer (blood pressure cuff) is placed on the patient's~     arm to compress a major artery (ischemia) with subsequent release of the cuff (reperfusion)~     for set periods of time. This has been shown to reduce blood pressure and major adverse~     cardiovascular events in other patient populations.~      We plan to conduct a trial to evaluate this intervention, ischemic conditioning, in patients~     with CF LVADs. We hypothesize that IC will cause a reduction in blood pressure and strokes in~     this patient population.~   "
116358|NCT02044458|"~     Study Design:~      Allocation: 2 arms Intervention Model: Single Group Assignment Masking: Open Label Primary~     Purpose: Treatment~      Detailed Description~      The utilization of a Foley catheter for induction of labor is well established. There are two~     techniques readily used for placing a Foley catheter. The most common method is under direct~     visualization of the cervix during a sterile speculum examination and the other method is to~     place a catheter during a digital cervical examination.~      Studies have reported the use of a rigid stylette (a thin wire inserted into a catheter to~     maintain rigidity) to guide the insertion of the Foley catheter decreases failure rate. The~     Foley catheter plus rigid stylette technique seems to be an efficient and safe method for~     labor induction. However, to our knowledge there is no study that assesses the difference~     between the standard digital placement of a Foley catheter versus the digital placement of a~     Foley catheter with stylette.~   "
116359|NCT02044445|"~     During controlled ovarian hyperstimulation (COH), human chorionic gonadotrophin (hCG) is~     administered to trigger the final follicular maturation before oocyte retrieval, in an~     attempt to mimic the physiologic effects of LH. The hCG is administered when more than three~     follicles ≥17mm in mean diameter have developed.~      The time interval between hCG administration and oocyte retrieval is of critical importance~     since the time after luteinizing stimulus is a period of intense processes including the~     start of luteinization, expansion of cumulus cells and oocyte meiotic maturation.~      The commonly practiced hCG administration time of 33 to 36 h in most IVF cycles aims to~     avoiding spontaneous ovulation before oocyte retrieval. However, several studies have shown~     that significantly more high quality embryos have been obtained with a prolonged~     hCG-to-oocyte interval of 38 h. It has been hypothesized that longer interval would be~     beneficial in improving oocyte quality and achieving optimal maturation.~      Currently there are no data on the effect of the time interval between hCG administration and~     oocyte retrieval on IVF outcome in GnRH antagonist cycles. The aim of this study is to~     determine whether there is any difference in in vitro fertilization outcome when oocyte~     retrieval takes place at 36 h or 38 h following hCG administration~   "
116360|NCT02044432|"~     The investigators hypothesize that by a 5-week treatment with ginger kidney compresses at~     least 2 of 3 main symptoms of the WOMAC (pain, stiffness, functionality) will be reduced at~     least 30% at the time of the post-measurement (after 5 weeks of therapy) in comparison to the~     respective control group (waitlist).~   "
116366|NCT02044354|"~     Taxotere is the current standard first-line chemotherapy for mCRPC and may be used as~     second-line therapy in good responders in first-line (Taxotere rechallenge). Jevtana has~     demonstrated a survival benefit versus mitoxantrone in patients progressing during or after~     Taxotere and is now the standard second-line chemotherapy. Taxotere and Jevtana have~     different toxicity profiles.~      Many patients who are receiving Jevtana for second-line treatment indicate they prefer this~     agent over Taxotere with regards to the general tolerance (namely peripheral neuropathy, nail~     changes, asthenia). This was not expected since Jevtana in post-Taxotere setting was~     associated with more grade 3-4 adverse events such as febrile neutropenia and diarrhea than~     Taxotere in first-line setting.~      The study design of CABA-DOC is similar to that of the PISCES trial which evaluated the~     patient preference between two standard treatments for first-line metastatic kidney cancer.~     Despite similar PFS improvements over placebo in phase III trials, results clearly showed~     that patients preferred pazopanib over sunitinib.~      A randomized phase III study is currently comparing the efficacy of Taxotere and Jevtana in~     first-line setting with overall survival as a primary end-point. Assessing patient preference~     between Jevtana and Taxotere would contribute to further identify differences between these~     two taxanes and clarify which one of these two taxanes should be used for second-line~     chemotherapy and perhaps for first-line chemotherapy in the future.~      Assessing patient preference between the two taxanes might be less biased in the first-line~     setting where patients have no previous experience with a taxane.~   "
116367|NCT02044341|"~     Children ages 2 months to less than 19 years old, who have been diagnosed with a middle ear~     infection may receive either medicated ear drops (AR01) or glycerin (placebo) ear drops. The~     patient or caregiver will measure the amount of ear pain before and after the ear drops to~     establish if the medicated ear drops decrease the amount of pain more than the placebo ear~     drops. The subject may leave the clinic 60 minutes after the first dose. The ear drops can be~     used up to 4 days, as needed for ear pain.~   "
116368|NCT02044328|"~     Adjuvant therapy has been proved effective in treating earlier stage or less advanced~     non-small-cell lung cancer. This study is designed to evaluate the efficacy of icotinib as~     adjuvant therapy in treating stage IIA-IIIA adenocarcinoma patients with EGFR mutation. The~     primary endpoint is disease-free survival.~   "
116369|NCT02044315|"~     The aim of the present study is to investigate whether increasing detection zones can~     effectively reduce inappropriate ICD therapies in primary prevention patients.~   "
116370|NCT02044302|"~     The investigators hypothesize that in mastectomy patients with breast reconstruction, the~     addition of bupivacaine and botulinum toxin (BT) will result in better pain control in the~     acute and chronic setting, compared to traditional pain management techniques which rely~     almost exclusively on opioid analgesics and sedatives like diazepam (valium). This~     expectation is based on the fact that bupivacaine produces pre-emptive analgesia and BT will~     produce muscle relaxation, the combination of which will target different sites of pain~     generation, thus producing better analgesia. We also hypothesize that additional benefits may~     accrue from this regimen including decreased nausea and vomiting, sedation and constipation~     as a result of diminished opioid use1.~   "
116371|NCT02044289|"~     The purpose of this study is to (a) measure how brain structure, metabolism (how the brain~     uses energy), and function predict response to electroconvulsive therapy (ECT) for treatment~     of depression; and (b) measure how ECT changes brain metabolism and function. We will ask you~     to undergo magnetic resonance imaging (MRI) at three sessions: (1) prior to your first ECT~     therapy session, (2) after having 4-6 ECT therapy sessions, and (3) approximately two months~     following your first ECT therapy sessions.~   "
116372|NCT02044276|"~     The primary objective of the study is to demonstrate non-inferiority of lipegfilgrastim to~     pegfilgrastim for the duration of severe neutropenia in the first cycle of chemotherapy.~   "
116373|NCT02044263|"~     Background: Insomnia is a highly prevalent and disabling disorder where Cognitive Behavior~     Therapy for Insomnia (CBT-I) is established as the best available treatment. Still, only a~     negligible number of patients with insomnia receive this treatment. One potential way of~     improving the dissemination of CBT-I is by using online adaptations of CBT-I. This is a new~     method for delivering CBT-I and it is not known how effective online treatment is compared to~     face-to-face CBT-I. This trial's purpose is to compare face-to-face CBT-I with online CBT-I.~     Because of the great advantage of online treatment in both availability and cost, the trial~     is designed as a noninferiority trial.~      Aim: To test if online CBT-I is noninferior in reducing insomnia complaints compared with~     CBT-I as delivered face-to-face by a therapist.~   "
116374|NCT02044250|"~     Objectives :~      To compare the efficacy and safety of clopidogrel monotherapy with aspirin monotherapy in~     patients who received dual or triple antiplatelet therapy for 1 year (± 6 months) after~     drug-eluting stent implantation for coronary artery disease~      Patient Enrollment :~      5530 patients enrolled at 55 centers in Korea~      Patient Follow-up :~      Clinical follow-up will occur at 1, 12 and 24 months.~      Primary Endpoint :~      Composite endpoint of MACE and major bleeding~      Secondary Endpoint :~      Device-oriented composite outcome including TLR (target lesion revascularization), TVR~     (target vessel revascularization), stent thrombosis, and minor GI (gastrointestinal)~     complications~   "
116375|NCT02044237|"~     Online study for patients with trichotillomania. 4 main hypothesis.~        1. Alexithymia and Trichotillomania correlated and regression analyses find association~          between them~        2. we will be able to find patient who have never been treated before. Those will suffer to~          the same amount as previously treated patients~        3. Decoupling will be more helpful than progressive muscle relaxation~        4. different constructs of emotion regulation will show different trait and state~          characteristics in patients with trichotillomania~   "
116376|NCT02044224|"~     The purpose of the study is to evaluate effects of dexmedetomidine on anaesthesia during IRE~     procedures for solid tumours~   "
116399|NCT02043925|"~     Observational study in 6 psychiatric hospitals in Flanders. Patients are included when a~     QT-prolonging drug is added to a medication profile that already contains a potential~     QT-prolonging drug. An ECG is taken before the administration of the new drug and a week~     after starting the new drug to investigate the change in duration of the QTc-interval. Risk~     factors for developing QT-prolongation and blood concentrations of potassium and creatinine~     are documented.~   "
116377|NCT02044211|"~     Depression is highly prevalent among patients with heart failure (HF) and associated with~     lower levels of health-related quality of life and physical functioning, and higher risk of~     rehospitalization and mortality, and higher health costs. This Project will compare the~     effectiveness of a blended telephone-delivered collaborative care intervention for treating~     both HF and depression to: (1) collaborative care for HF-alone (enhanced usual care; eUC);~     and (2) doctors' usual care for depression (UC). If proven effective and cost-effective,~     the potentially more powerful, scalable, efficient blended care approach for treating HF~     and co-morbid depression could have profound implications for improving chronic illness care~     and stimulate development of blended interventions for treating other clusters of related~     medical conditions.~   "
116378|NCT02044198|"~     The purpose of this study is to evaluate an experimental malaria vaccine for its ability to~     prevent malaria infection or disease in a blood-stage challenge model (when volunteers are~     infected with malaria parasites using malaria-infected red blood cells). The vaccine being~     testing is a protein called FMP2.1, which is given with an adjuvant (a substance to improve~     the body's response to a vaccination) called AS01B.~      The aim is to use this protein and adjuvant to help the body make an immune response against~     parts of the malaria parasite. This study will enable assessment of:~        1. The ability of the vaccine to prevent malaria infection.~        2. The safety of the vaccine in healthy participants.~        3. The response of the human immune system to the vaccine.~      This will be done by giving participants three vaccinations and then exposing them to malaria~     infection by transfusing a small number of red blood cells infected with malaria under~     carefully regulated conditions. Participants will be followed closely to observe if and when~     they develop malaria. If the vaccine provides some protection against malaria, participants~     will take longer to develop malaria than usual or will not develop malaria at all.~      The study will enrol 15 participants to be vaccinated and then challenged with malaria in~     addition to recruit 15 individuals to be control subjects.~   "
116379|NCT02044185|"~     Acute Graft-versus-host disease(aGVDH) after allogeneic hematopoietic stem cell~     transplantation is one of the meaningful issues in aspect of patient's recovery and survival.~     in recent years, the understanding of the pathology of GVHD is much important to prevent or~     treat aGVHD. additionally, (oral) mucositis is one of the problems in patients with high dose~     chemotherapy, and mucositis by high-dose chemotherapy is related to HMGB-1 as proinflamtory~     cytokines. HMGB1 is a nuclear protein acts as a transcription factor, but, if it was released~     to the outside of cells by damaged cell or necrotic tissues, it works as cytokines for~     promoter of inflammation and cancers. at this point, there are no reported articles about~     correlation of HMGB1 and aGVHD in human. recently, we have seen excessive secretion of serum~     HMGB1 in mouse model, then base on this results, we will check correlation of HMGB1 and~     aGVHD/ oral mucositis in human.~   "
116380|NCT02044172|"~     RATIONALE: Radical prostatectomy is surgery to remove the entire prostate. Radiation therapy~     uses high-energy x-rays or other types of radiation to kill tumor cells. Sometimes the tumor~     may not need treatment until it progresses. In this case, active surveillance may be~     sufficient. It is not yet known which treatment regimen is more effective for localized~     prostate cancer.~      PURPOSE: This randomized phase III trial is studying active monitoring to see how well it~     works compared with radical prostatectomy or radiation therapy in treating patients with~     localized prostate cancer.~   "
116381|NCT02044159|"~     Approximately 20,000 children per year in North America present to the hospital with severe~     shock. Children who develop this condition have very low blood pressures and as a result may~     suffer damage to their internal organs and may even die. Some children with this condition~     may significantly benefit from the use of steroids but steroids in such patients may also~     have potential side effects. Therefore it is important to study the use of steroids carefully~     in these children. The STRIPES research program will examine the effectiveness and safety of~     steroids in children. Before conducting a large, randomized controlled trial (RCT), a pilot~     study (STRIPES Pilot Study) will be conducted in multiple sites across Canada. The STRIPES~     Pilot Study will allow testing of the STRIPES study protocol in a smaller group of patients.~   "
116382|NCT02044146|"~     In patients with heart attacks, the treatment of choice is to restore blood flow with~     percutaneous coronary intervention (PCI) (use of stents (metal meshes) to open blockages).~     After PCI, the standard drug treatment includes aspirin and clopidogrel. These medications~     block full function of the platelet cells, which are responsible for clotting. Despite their~     use, patients after PCI are at risk for heart attacks, sudden clotting of stents or death. A~     major contributor may be resistance to clopidogrel. New more potent drugs, which can overcome~     the resistance, are now available; however, they come with an increase chance of severe~     bleeding and costs. An ideal solution would be to identify at-risk patients and selectively~     treat them with more potent drugs, while lower-risk patients continue with clopidogrel. This~     type of strategy (personalized strategy) would decrease heart attacks and death (compared to~     clopidogrel), while also preventing bleeding complications (compared to treating all patients~     with the new drugs).~      Of resistant patients, many carry genes (inherited units) that prevent proper absorption of~     clopidogrel. Our group has developed and tested a new bedside genetic test, which identifies~     carriers of at-risk genes. However, this technique alone does not identify all at-risk~     patients. Consequently, we have now devised a novel tool, which combines genetics with~     patient characteristics to identify high-risk patients.~      The present study combines this new tool into a strategy for personalized treatment. Patients~     with heart attacks who undergo PCI will be randomly assigned to 1 of 3 strategies: a) new~     personalized strategy, b) clopidogrel strategy (previous standard drug) or c) ticagrelor~     strategy (stronger approved drug). The function of the platelet cells will be measured at 1~     month to determine potential benefits. Evaluation of this new personalized strategy is~     important for improving patient outcomes after PCI. The hypothesis is that patients receiving~     a personalized strategy will have decrease risk for future heart attacks and bleeding.~   "
116383|NCT02044133|"~     The study will be proposed to man entering the prison of La Roche sur Yon. Participants will~     be randomized into two arms: one arm realize a dosage of vitamin D at the entrance and 6~     months after the entry and the second arm will carry only a dosage six months after entry.~      the purpose of the study is to determine the interest of dosage of vitamin D in biological~     assessment of entry into prison house.~   "
116384|NCT02044120|"~     The purpose of this study is to define the dose-limiting toxicities and maximum tolerated~     dose of the poly ADP-ribose polymerase inhibitor niraparib and escalating doses of~     temozolomide in patients with pre-treated incurable Ewing sarcoma.~   "
116400|NCT02043912|"~     In this epidemiological point prevalence study, medication profiles of patients with~     haloperidol treatment will be checked for drug interactions with risk of QT-prolongation.~     Additional clinical risk factors for developing QT-prolongation and safety measurements will~     be documented.~   "
116401|NCT02043899|"~     This study aims to show that 3-dimensional PET/CT imaging with a new novel PET tracer (called~     [124I]mIBG) can detect as many or more sites of neuroblastoma (a type of childhood cancer)~     compared to the recommended 1-dimensional routine scans (called [123I]mIBG planar~     scintigraphy).~   "
116385|NCT02044107|"~     This project applies a randomized community design to test the effectiveness of health center~     level co-packaging and counseling messages to improve provider and caregiver behavior in the~     treatment of diarrhea with zinc & oral rehydration salts (ORS) and treatment of pneumonia~     with zinc & antibiotics in children aged 2-59 mo old. We will evaluate the adherence of~     caregivers in 10 health posts in 5 municipalities randomly assigned to receive the health~     center level co-packaging and counseling messages in addition to current standard care, by~     comparing them with the caregivers in 10 health posts in 5 municipalities randomly assigned~     to the receive only the current standard of care. Cost-effectiveness of co-packaging at the~     health-center level, as a means of improving provider treatment and counseling practices and~     caregiver adherence, will be evaluated.~      The main objective is to establish the effectiveness of a facility level co-packaging and~     counseling messages for increasing the adherence by caregivers of children aged 2-59 mo old~     to the prescribed 10 day treatment with zinc to complement ORS for the treatment of diarrhea~     and zinc to complement the antibiotics for the treatment of pneumonia diagnosed and treated~     in public health posts.~      Specific Quantitative Objectives:~      • To determine if visible co-packaging with pre-tested counseling messages:~        -  Improves adherence of caregivers of children towards the prescribed zinc treatment.~        -  Improves knowledge, awareness or attitudes of caregivers of children and health~          providers at public health care centers towards the prescribed zinc treatment.~        -  Results in overall increase in health care-seeking for the treatment of diarrhea and~          pneumonia at public health care centers.~      Specific Qualitative Objectives:~        -  To establish the perception, attitudes and experiences of caregivers towards the visible~          co-packaging with pre-tested counseling messages to promote the prescribed zinc~          treatment.~        -  To establish the perception, attitudes and experiences of health providers at public~          health care centers towards the visible co-packaging with pre-tested counseling messages~          to promote the prescribed zinc treatment.~        -  To establish the perception, attitudes and experiences of children aged 4 to 5 years old~          towards the visible co-packaging with pre-tested counseling messages to promote the~          prescribed zinc treatment.~   "
116386|NCT02044094|"~     This is a multiple-dose study in non-treatment seeking male and female subjects with moderate~     to severe opioid use disorder who meet criteria from the Diagnostic and Statistical Manual of~     Mental Disorders, 5th Edition (DSM-5) to evaluate the effectiveness of RBP-6000 to block the~     effects of exogenous opioids.~      The primary objective of this study was to demonstrate that the Drug Liking visual analog~     scale (VAS) measured after challenge with 6 mg (Dose 1) and 18 mg (Dose 2) hydromorphone was~     noninferior to the Drug Liking visual analog scale (VAS) measured after challenge with~     placebo at Weeks 1-4 post first injection of subcutaneous buprenorphine 300 mg (RBP-6000).~   "
116387|NCT02044081|"~     The focus of the study is to evaluate the safety of multiple study drug administrations and~     the study drug selectively reducing or eliminating a specific bacteria in the mouth. It will~     compare a liquid and gel product applied in different modes.~   "
116388|NCT02044068|"~     Vertical HIV transmission has been dramatically reduced by the use of combined antiretroviral~     therapy in HIV-infected pregnant women. Among the most often used drugs, several have dual~     activity, against HIV and HBV: lamivudine, emtricitabine, tenofovir. Studies about vertical~     HBV transmission from HIV-HBV co-infected pregnant women are rare in developed countries. The~     study hypothesis is a major reduction of the risk of HBV vertical transmission.~   "
116389|NCT02044055|"~     HBV can be transmitted from mother-to-child, with a risk increasing according to maternal HBV~     DNA during pregnancy. HDV is a defective virus using HBs Ag for its own replication.~     Nucleosides analogues have only a minor impact on quantitative HBs Ag level. Data about~     vertical HDV transmission are old, justifying a new study.~   "
116390|NCT02044042|"~     Vertical HCV Transmission has been extensively studied, with a risk around 5% (range: 3 to~     10%). Spontaneous viral clearance in infected children during childhood can occur, but data~     about this phenomenon are scarse, justifying the study.~   "
116391|NCT02044029|"~     This non-drug, single center, 24-week, longitudinal study in ambulant spinal muscular atrophy~     (SMA) patients and in age- and gender-matched healthy volunteers will assess the detection of~     disease progression by magnetic resonance imaging (MRI) and the Muscle Function Measure (MFM)~     test.~      Each participant will be evaluated in three testing sessions: at baseline, at Week 12 and at~     Week 24. Both patients and volunteers will undergo MRI scans. Patients will additionally~     undergo testing of motor function and have blood samples taken for Survival of the Motor~     Neuron (SMN) genes, proteins and mRNA analysis.~   "
116392|NCT02044016|"~     The purpose of this study is 1) to develop and validate a new measurement to assess the~     length of the Achilles tendon after rupture, and 2) to examine if goniometer measurement of~     the ankle joint is a better method.~   "
116393|NCT02044003|"~     The study is intended to evaluate the safety and feasibility of using the Intact Vascular~     (Innovasc) Tack-It Endovascular Dissection Repair System (Tack Intravascular Staple System)~     in patients with vascular flaps in the infrainguinal due post-angioplasty dissection.~   "
116394|NCT02043990|"~     Neurally Adjusted Ventilatory Assist (NAVA) is a new form of partial support wherein the~     machine applies positive pressure throughout inspiration in proportion to the electrical~     activity of the diaphragm (EAdi), as assessed by trans-esophageal electromyography. To test~     the hypothesis that NAVA could provide better patient-ventilator synchrony during NIV~     delivered by nasal-facial mask as compared to conventional flow-triggered PSV in infants with~     Acute Respiratory Failure.~   "
116395|NCT02043977|"~     Insomnia is a widespread condition in which approximately one-third of adults in the United~     States are symptomatic with 6% of the population meeting the diagnostic criteria for~     insomnia. There is an increased risk of insomnia in certain segments of the population~     including women, middle-aged and older adults, shift workers and individuals with medical or~     psychiatric disorders. Individuals with insomnia have a decreased quality of life compared to~     those who report other serious illnesses such as major depression and congestive heart~     failure. Chronic insomnia can be caused by medications, drug or alcohol abuse, psychiatric~     disorders, medical and neurologic disorders. It can impair cognitive and physical~     functioning.~      Propofol is an approved drug administered intravenously for use in the induction and~     maintenance of anesthesia or sedation. Some research suggests that propofol when administered~     as a two hour infusion may improve the ease of sleep onset, sleep quality, ease of awakening~     and the integrity of behavior following waking.~      This study will be conducted in the Broward Health Medical Center Sleep Lab, under the direct~     care of a Board Certified Anesthesiologist, dedicated to the study involving participants who~     have refractory chronic primary insomnia and have not responded to conventional pharmacologic~     therapies within the past 90 days. Each qualifying participant will receive an IV infusion of~     the study medication for 5 consecutive nights. Assessments including polysomnography with~     completion of questionnaires will occur at screening, Days 1 through 5 of study product~     administration, Day 6 and Day 90. Follow-up questionnaires will also be distributed on Day~     180.~   "
116396|NCT02043964|"~     This is a multicentric and prospective study for the validation of a diagnostic method in~     multiple sclerosis. Our hypothesis is that there is a characteristic profile of tears that~     can be recognized in order to help in the diagnosis of this pathology and that could possibly~     replace the lumbar punction which is an invasive method. Semi-automatic and automatic~     techniques of isoelectric focusing will be developed for analyzing data from tears. These~     results will help in the identification of markers of this disease.~   "
116402|NCT02043886|"~     Postprandial hypotension carries a risk of significant morbidity and morbidity including~     syncope, falls, dizziness, fatigue, stroke and myocardial infarction. Current therapy~     consists of dietary manipulation (smaller meals) caffeine and octreotide injections all of~     which are suboptimal and poorly studied.~      The study hypothesis is that administration of Acarbose will decrease the drop in blood~     pressure and increase in heart rate in response to food in people with Type 2 diabetes.~      Acarbose suppresses postprandial glycemia be slowing digestion in the small intestine and~     delaying gastric emptying.~      This is a placebo-controlled cross over study involving 2 - 4 hour Meal Tests. During the~     meal tests heart rate, blood pressure, cerebral artery velocity will be measured. During one~     meal test subjects will receive Acarbose 50 mg po and during the other will receive placebo.~     Order of treatment assignment will be done in randomized fashion. A total of approximately~     200 cc of blood will be drawn during each meal test.~   "
116403|NCT02043873|"~     Objectives: The aim of this prospective, randomized, triple-blind cohort study was to assess~     the longevity of repairs to localized clinical defects in composite restorations that were~     initially scheduled to be treated with a restoration replacement Methods: 28 patients aged 18~     to 80 years with 50 composite restorations were recruited.Restorations with clinically~     diagnosed secondary caries (Charlie) or undercontoured anatomical form defects (Bravo) were~     randomly assigned to the Repair (n = 25) or Replacement (n = 25) group, the quality of the~     restorations was scored according to the modified USPHS criteria. A Wilcoxon test was~     performed for comparisons between the same groups (CI=0.05). A Friedman test was utilized for~     multiple comparisons between different years of the same group.~   "
116404|NCT02043860|"~     In this phase I trial, patients with multiple myeloma will receive standard high dose~     melphalan with autologous stem cell rescue. In addition the pre-transplant conditioning will~     include targeted total marrow irradiation (TMI). This conventional 3+3 phase I trial will~     increase the dose of TMI until the maximum tolerated dose (MTD) is reached. Initial patients~     enrolled will receive the lowest possible dose of 3Gy. Maximum dose will be 12Gy.~   "
116405|NCT02043847|"~     In this phase I trial, patients with relapsed or refractory multiple myeloma will receive~     standard high dose melphalan with autologous stem cell rescue. In addition the pre-transplant~     conditioning will include targeted total marrow irradiation (TMI). This conventional 3+3~     phase I trial will increase the dose of TMI until the maximum tolerated dose (MTD) is~     reached. Initial patients enrolled will receive the lowest possible dose of 3Gy. Maximum dose~     will be 9Gy.~   "
116406|NCT02043834|"~     The aim of the present study is to evaluate an innovative virtual reality-based balance~     training intervention for improving clinically relevant motor performances (balance and gait)~     in older adults.~      We hypothesize that the virtual reality-based balance training intervention will improve~     balance and gait performances in older adults compared to a control group receiving usual~     care only.~   "
116407|NCT02043821|"~     Colorectal cancer patients with metastases (mCRC) at response under first-line chemotherapy~     are candidates for an convenient maintenance treatment.~   "
116408|NCT02043808|"~     The objective is to assess the safety and effectiveness of new dabigatran and warfarin~     patients diagnosed with NVAF in the US DoD population.~   "
116409|NCT02043795|"~     The aim of this study is to study the safety and clinical efficacy of a novel Bioabsorbable~     Everolimus Eluting Bioresorbable Vascular Scaffold System (BVS, Abbott Vascular) in subjects~     with critical limb ischemia (CLI) following percutaneous transluminal angioplasty (PTA) of~     the tibial arteries.~   "
116410|NCT02043782|"~     The aim of the investigation was to investigate the performance and safety of a new ostomy~     product~   "
116411|NCT02043769|"~     The Pediatric Enhanced Surveillance Study is a three part study of HIV-infected infants and~     children in South Africa to examine, clinical, immunologic, virologic, metabolic,~     psychosocial and behavioral outcomes. This study has two parts: (1) comprehensive~     de-identiﬁed records review of all HIV-infected children enrolled in at the pediatric~     Wellness and ART clinics at the ﬁve study sites; and (2) a prospective cohort surveillance~     study with active consented enrollment with 12-24 months of follow-up. As part of the~     prospective cohort, the study will aim to collect outcomes on children lost to follow-up,~     including causes of death through review of death certiﬁcates in the clinical chart and~     through verbal autopsy reports. The study will provide insights into overall outcomes for the~     larger pediatric patient populations in the province and South Africa. This work is designed~     in collaboration with the provincial health authorities of the Eastern Cape Department of~     Health (EC), The International Center for acquired immune deficiency syndrome (AIDS) Care and~     Treatment Programs (ICAP) South Africa and Center of Disease Control (CDC)-South Africa in~     support of the South African National ART Program for Children and aims to collect and~     analyze accurate, relevant and useful information that will be available on children seen at~     facilities. For the prospective cohort study, we will aim to enroll 400 children newly~     initiated on ART at 5 health facilities in the Eastern Cape of South Africa who will be~     actively followed for up to 24 months.~   "
116412|NCT02043756|"~     The purpose of the study is to examine the toxicity profile, maximum tolerated dose (MTD),~     and pharmacokinetics of Mitoxantrone Hydrochloride Liposome Injection.~   "
116413|NCT02043743|"~     Premature ovarian failure (POF), also known as premature ovarian insufficiency, primary~     ovarian insufficiency (this is the most accurate term as some women may still conceive),~     premature menopause, hypergonadotropic hypogonadism is defined as failure of the ovary to~     function adequately in a woman younger than 40 years, in its role either as an endocrine~     organ or as a reproductive organ, a condition characterized by amenorrhea, hypoestrogenism,~     and elevated serum gonadotropin levels (which demonstrate that the ovaries are no longer~     responding to circulating FSH by producing estrogen and developing fertile eggs) in women~     younger than 40 years. This condition occurs in approximately 1% of women and it has~     important physical and psychological consequences/impact in those patients.~      The purpose of this study is to investigate the role of the transplantation of bone marrow~     derived stem cells into ovarian tissue for treatment of premature ovarian failure and to~     assess their ability to differentiate into germ cells.~   "
116602|NCT02041260|"~     Phase II, non-randomized, open-label study to determine the efficacy of cabozantinib as a~     firstline treatment for patients with differentiated thyroid cancer (DTC). Subjects will~     receive drug at a starting dose of 60mg PO QD. Subjects can receive drug as long as they~     continue to derive clinical benefit or until they experience unacceptable drug-related~     toxicity.~   "
116414|NCT02043730|"~     Pancreatic cancer is the fourth cause of cancer mortality: there are different treatment~     approaches to locally advanced pancreatic cancer management.~      Generally, gemcitabine alone is considered a reasonable approach for advanced pancreatic~     cancer patients but we need a chemotherapeutic regimen able to prevent as much as possible a~     progression of the disease. Nab-paclitaxel (Abraxane) recently demonstrated an interesting~     activity profile in advanced pancreatic cancer. A combination of Nab-paclitaxel and~     gemcitabine has been demonstrated superior to gemcitabine alone in metastatic patients.~   "
116415|NCT02043717|"~     The investigators study is designed to test the hypothesis that correction of vitamin D in CF~     patients can increase their lung function and decrease the number of their pulmonary~     exacerbations.~   "
116416|NCT02043704|"~     This randomized controlled trial will evaluate the effects of perioperative intravenous (IV)~     acetaminophen on postoperative narcotic consumption and pain scores in subjects undergoing~     vaginal reconstructive surgery. One hundred subjects will be randomly assigned to receive~     either IV acetaminophen or IV placebo. Those in the IV acetaminophen group will receive~     1000mg IV every 6 hours for 24 hours beginning prior to anesthesia induction. The control~     group will receive placebo saline infusions at the same time intervals. All subjects will~     receive as needed (prn) IV narcotic for additional pain relief. Visual analog scales (VAS)~     regarding pain will be evaluated at 18 and 24 hours postoperative and immediately prior to~     discharge. We will also collect total IV narcotic consumption. We hypothesize that subjects~     receiving IV acetaminophen will have lower VAS scores and decreased total narcotic~     consumption in comparison to the control group.~   "
116417|NCT02043691|"~     This is a single-center study to evaluate the safety and effectiveness of three~     investigational devices, the Cook Custom Aortic Endograft, the Zenith t-Branch Endovascular~     Graft, and the Surgeon-Modified Endografts in the treatment of aortic pathologies involving~     the visceral vessels.~      The three investigational devices offer an endovascular approach to treat complex aortic~     pathologies that cannot be treated with commercially available devices. This customized,~     endovascular approach has the potential to decrease hospital length of stay, pulmonary~     complications, and in-hospital mortality.~   "
116418|NCT02043678|"~     To determine if the addition of radium-223 dichloride to standard treatment is able to~     prolong life and to delay events specific for prostate cancer which has spread to the bone,~     such as painful fractures or bone pain which needs to be treated with an X-ray machine.~   "
116419|NCT02043665|"~     The purpose of this trial is to assess the ability of CVA21, either alone (Part A) or in~     combination with pembrolizumab (Part B), to reach and to replicate in existing tumors (while~     sparing normal cells) and to establish a safe multi-dose schedule of the virus for the~     treatment of solid tumors where enhanced expression of ICAM-1 and/ or DAF receptor occurs.~      This trial consists of 2 sequential parts: VLA-009 (Part A) conducted only in the UK and~     employed CVA21 as a monotherapy in NSCLC, castrate-resistant prostate cancer, melanoma and~     bladder cancer. VLA-009 (Part B) conducted in the US, AUS and UK employs CVA21 with~     pembrolizumab in NSCLC and bladder cancer.~      Both VLA-009A and VLA-009B are open-label, multi-center, ascending dose escalation (3+3~     design) dose-finding and signal-seeking studies.~      Part A of the study is now complete and closed to enrolment. Part B is currently enrolling.~   "
116420|NCT02043652|"~     Background: The World Health Organization recommends that antimalarial treatment policies be~     evaluated every few years to check their efficacy. P. vivax malaria is the most common~     species in Brazil and cases are concentrated in the Amazon Region in Brazil.~      Objectives: Assess the efficacy of chloroquine and primaquine for the treatment of P. vivax~     infections in Cruzeiro do Sul, Acre, Brazil.~      Methods: An in vivo drug efficacy study will be conducted in Cruzeiro do Sul, Acre State,~     Brazil. At least 117 study participants ≥5 years of age with parasitologically confirmed P.~     vivax monoinfections will be treated under supervision with chloroquine (CQ) for three days~     at a daily dose of approximately 25 mg/Kg in accordance with the Brazilian National Malaria~     Control guidelines. For patients with normal glucose 6 phosphate dehydrogenase activity~     levels, investigators will add primaquine at dose of 0.5mg/Kg per day for 7 days. Clinical~     and parasitologic parameters will be monitored over a 28-day follow-up period to evaluate~     drug efficacy and for a total period of 168 days (6 months) to evaluate chances of~     recrudescence, relapse, or reinfection. Blood samples will be taken to measure the CQ levels~     in blood on Day 7 and day of failure, if occurring in the initial 28 days of follow up. In~     addition, a blood sample will be collected on filter paper on first day and on day of~     suspected failure to help differentiate parasite genotypes using techniques based on~     polymerase chain reaction. Results from this drug efficacy study will be used to assist the~     Brazilian Ministry of Health in assessing their national malaria treatment policy for P.~     vivax malaria.~   "
116421|NCT02043639|"~     In this study, the goal is to find out if the clinicCompanion™ is effective in measuring~     range of motion when compared to the goniometer. Currently, the goniometer is an approved~     device to measure range of motion by the FDA, but the clinicCompanion™ is not.~   "
116422|NCT02043626|"~     Our long-term objective is to reduce the rates and risk of childhood obesity via school-based~     nutrition and physical activity policies. Using a randomized design, we propose to monitor~     and evaluate how Connecticut's first-ranked District Wellness Policy, in the New Haven Public~     School district, is implemented and determine its impact on children's obesogenic behaviors,~     weight outcomes, and school performance. This study is designed to significantly advance~     empirical research on school wellness policies and to provide important evidence to guide~     future interventions in schools and communities - translating science to improved health of~     the public.~   "
116423|NCT02043613|"~     The study is designed to investigate the effect of physical surroundings on the effect of~     exercise therapy for knee and hip pain.~   "
116424|NCT02043600|"~     The aim of this randomized trial is to investigate the effects of a 12-week yoga intervention~     compared to self-care on quality of life, stress, psychological health, and physiological~     parameters in 77 patients with ulcerative colitis.~   "
116425|NCT02043587|"~     The objective of this protocol is to improve survival for adults with acute lymphoblastic~     leukemia or acute lymphoblastic lymphoma by reducing systemic and central nervous system~     (CNS) relapse with acceptable toxicity using intensive chemotherapy with liposomal cytarabine~     (Depocyt®) CNS prophylaxis.~   "
116603|NCT02041247|"~     The purpose of this study is to evaluate the protective effect of VAC-3S in controlled HIV~     patients receiving standard of care antiretroviral treatment.~   "
116426|NCT02043574|"~     Strokes are very common in the United States and occur more in the elderly. The number of~     strokes is likely to double in the next 50 years. Many stroke survivors are sedentary and~     have a poor dietary intake, which results in abnormalities in fuel utilization (eg~     carbohydrate versus fat). This study will examine the effects of dietary modification and~     treadmill training on fuel utilization and physical function. We will study skeletal muscle~     oxidative stress in chronic stroke patients and the ability to employ dietary modification~     and exercise training to reverse these abnormalities in this ethnically diverse population.~   "
116427|NCT02043561|"~     The aim of this study will be to investigate the effect of rectal distension, controlled by~     electronic barostat, on cognitive control ability in healthy subjects. We will use the Stroop~     task and an intertemporal choice task as standard instruments. Like bladder control and~     rectal control, both Stroop task performance and intertemporal choices - though very~     different tasks at the surface - are dependent on the conflict monitoring function of the~     anterior cingulate cortex. The Stroop task requires the naming of the print color of a series~     of visually presented color words, and reaction time and error rates are typically used as~     performance indicators. When word color and word meaning do not match, performance of the~     task (color naming) requires the inhibition of a (near) automatic response (word reading).~     The intertemporal choice task consists of a series of choices between a sooner smaller~     monetary reward and a larger but later reward. The choices are constructed such that they~     allow the estimation of a discount parameter, which is an index for the level of~     impulsiveness manifested by the participant at the time the choices are made.~      The hypothesis is that the inhibition induced by the urge generated during rectal distension~     will improve cognitive inhibitory performance, as has previously been shown for bladder~     filling.~   "
116428|NCT02043548|"~     The purpose of this multi-center pilot study is to determine if the drug tocilizumab~     (Actemra) is effective in the treatment of patients with refractory adult polymyositis (PM)~     and dermatomyositis (DM).~   "
116429|NCT02043535|"~     Myocardial perfusion imaging (MPI) is a nuclear scan using a radioisotope to see blood flow~     to the muscles of the heart when the heart is at rest and when it is under stress. The stress~     test in MPI can be done using medications, such as adenosine, that dilate coronary arteries~     and increase blood flow. Similarly, elevated carbon dioxide (CO2) levels in the blood, or~     hypercapnia, also dilates arteries and increases blood flow. Thornhill Research Inc. has~     developed the RespirAct ™ Gen4 sequential gas delivery system used to control CO2 levels in~     the blood. The RespirAct ™ Gen4 can deliver precise amounts of CO2 through a mouthpiece for~     inhalation to increase CO2 levels in the blood and thereby increasing blood flow like during~     stress.~      The objective of this study is to compare the differences in blood flow through the arteries~     of the heart during stress with hypercapnia and adenosine MPI. The imaging will be done using~     positron emission tomography (PET) with the radioisotope, or tracer, called Rubidium (Rb-82).~     The Rb-82 is given through a pump, or elution system.~      The investigators hypothesize that hypercapnia will induce a stress-to-rest increase in~     myocardial blood flow by a factor of 2 or more in myocardial regions supplied by non-stenotic~     arteries in normal volunteers and participants with coronary artery disease.~   "
116430|NCT02043522|"~     This study is being done with a radioisotope, 123I-mIBG (Adreview), to develop a nuclear~     diagnostic imaging test for patients with decreased heart function which can be used to~     predict the progression of the heart disease and provide the appropriate clinical treatment.~     The types of patients to be studied include patients who have had a heart attack where heart~     muscle may be damaged and patients diagnosed with heart failure who have enlarged hearts.~     Both conditions may cause poor muscle contraction and disturbances in electrical signal~     conduction. There will also be a control group of participants with no evidence of heart~     disease.~      123I-mIBG has been shown to be effective in assessing the areas of the heart being activated~     involuntarily by the sympathetic nervous system (SNS). 123I-mIBG is an iodine based~     radioisotope that is chemically similar to norepinephrine (NE) in the heart. NE is~     responsible for the way the SNS regulates heart functions such as heart rate and the force of~     heart contractions. NE acts automatically to maintain a homeostasis or balance within the~     SNS. The amount of 123I-mIBG, mimicking NE, that appears on the nuclear image using the~     heart-to-mediastinum ratio (H/M ratio), was predictive of the progression of heart failure,~     arrhythmias (irregular heartbeats) and cardiac death.~      Two different types of single photon emission computed tomography (SPECT) imaging will be~     used: standard SPECT and cadmium-zinc-telluride (CZT) SPECT. The investigators hypothesize~     that CZT SPECT will have greater H/M ratios than standard SPECT imaging.~   "
116431|NCT02043509|"~     The overall aim of the study is to estimate the likely impact of the MiQuit text message~     based smoking cessation service for pregnant smokers and to establish robust estimates for~     the key factors which would be required in order to design a larger definitive trial of this~     intervention(MiQuit).~      These key factors include: the range of recruitment rates in different centres; quit rates~     amongst participants; feasibility of assessing smoking status of participants in later~     pregnancy; and the likely effect of MiQuit when women are offered this in National Health~     Service (NHS) settings.~   "
116432|NCT02043496|"~     The purpose of the study is to test a newly developed individual psychotherapy treatment for~     binge eating disorder in adults. This treatment is a type of individual psychotherapy called~     Integrative Cognitive-Affective Therapy (ICAT) that focuses on helping people change their~     behaviors, feelings, thoughts about themselves, and relationships. This new treatment is~     being compared to an existing treatment called Cognitive-Behavior Therapy-Guided Self Help~     (CBTgsh), which focuses on changing behavior patterns through the use of reading and homework~     assignments along with sessions with a therapist. The primary hypothesis of this~     investigation is that ICAT will be associated with greater reductions in binge eating at end~     of treatment and follow-up compared to CBTgsh.~   "
116433|NCT02043483|"~     Untreated Obstructive Sleep Apnea Syndrome (OSAS) has long-term complications, namely~     metabolic imbalances (obesity, dislipidemia, type 2 diabetes mellitus). Until now, no~     molecular markers for this physiopathological connection have been identified.~      This project aims to determine non-invasive biomarkers that may allow better comprehension of~     the metabolic consequences of OSAS, as well as assess the effect of Continuous positive~     airway pressure (CPAP) on these metabolic parameters.~      This project will integrate the clinical, metabolic, genetic/proteomic and biologic systems~     to further explore the mechanisms behind OSAS, as well as the effect of the treatment with~     CPAP.~   "
116435|NCT02043457|"~     The Investigational Weight Management Clinic at the University of Michigan was created to~     identify strategies that will result in cost-effective, long term weight management for~     overweight and obese individuals. The driving hypothesis of the clinic is that the 'one size~     fits all' philosophy is untenable with a complex disease such as obesity. The clinic will~     serve as a portal for patients to choose standard clinical care or to explore alternatives~     from a variety of clinical studies offered through the clinic. These studies will include~     further investigations into nutrition, the biological basis of weight and weight management~     and protocols using approved and experimental pharmaceuticals.~   "
116436|NCT02043444|"~     Compare FDG PET-CT parameters between azoospermia patients having an extraction of sperm~     cells by positive testicular extraction and those with a negative extraction.~   "
116437|NCT02043431|"~     The purpose of this study is to develop a biobank containing samples of 2,000 patients~     treated in a tertiary cardiology hospital containing electronic medical records and genetic~     data in genome-wide scale for performing genetic association studies for validation and~     development of medical decision routines that help the clinical management of heart failure~     patients.~   "
116438|NCT02043418|"~     This study aims to assess the long-term outcomes of children infected with HIV, having~     participated in the ANRS 12140 PediacamI study, in terms of: clinical and immunovirological~     response to ARV therapy, long-term ARV tolerance, and the impact of family environment and~     lifestyle on adherence to ARV treatment.~   "
116439|NCT02043405|"~     The investigators will use exercise training and weight loss to discover localized lipid~     species related to diabetes risk in people.~   "
116440|NCT02043392|"~     Anastomosis of intestine or other viscera currently requires open or laparoscopic surgery and~     is often the most difficult, time-consuming, and expensive part of many operations. We have~     developed a device (Magnamosis) that may create compression anastomoses more easily,~     quickly, and less expensively than sutures or staples. The Magnamosis device consists of two~     23-mm diameter, convex-concave, radially symmetric ring magnets encased in polycarbonate. One~     magnet is placed in the lumen of each viscus to be joined, the magnets self-align, and a~     compression anastomosis is achieved by tissue remodeling. We have completed extensive~     pre-clinical studies in animals and have shown that Magnamosis can be used to accomplish~     gastrojejunostomy, jejunojejunostomy, duodenal-colostomy, and colo-colostomy safely and~     effectively using available endoscopic and minimally invasive surgery techniques. We are now~     conducting a small first-in-human study to obtain clinical data in support of the safety and~     early feasibility of the Magnamosis device.~   "
116441|NCT02043379|"~     The purpose of this study protocol is to determine if administering Intravenous~     Immunoglobulin (IVIG) for treatment of cardiopulmonary bypass (CPB) induced~     hypogammaglobulinemia in the early post-operative period can impact post-surgical outcomes~     (i.e., infection, fluid overload, and associated morbidities).~   "
116442|NCT02043366|"~     Purpose:~      To explore and compare antihyperalgesic effects of butorphanol, flurbiprofen axetil, and a~     combination of both received before anesthesia induction.~      To evaluate and examine the incidence of adverse effects with the purpose of selecting the~     optimum dose.~   "
116443|NCT02043353|"~     Sleep-disordered breathing in children is characterized by recurrent events of partial or~     complete upper airway obstruction during sleep, resulting in disruption of normal gas~     exchange (intermittent hypoxia and hypercapnia) and sleep fragmentation. The major symptom is~     snoring or noisy breathing. Sleep Disordered Breathing (SDB) is a wide spectrum of disorders~     that includes primary snoring, UARS and OSA. The main etiology for SDB in children is~     enlarged tonsils and adenoids and therefore the first line of treatment in pediatric SDB is~     adenotonsillectomy.~      The objectives of this study are:~        1. To investigate the natural history of primary snoring~        2. To investigate the effect of seasonality on SDB severity~        3. To compare the effect of adenoidectomy to adenotonsillectomy in the treatment of SDB in~          children~        4. To characterize the children referred for repeated PSG following adenoidectomy or~          adenotonsillectomy and the indications for second PSG evaluation.~   "
116444|NCT02043340|"~     In recent years, there has been a growing interest in the use of dental lasers for treatment~     of periodontal diseases. Commercially available photodynamic therapy for periodontal diseases~     utilizes methylene blue as a photosensitizer. In this study, the effects of a novel~     photosensitizer dye, indocyanine green (ICG), as an adjunct to nonsurgical treatment of~     chronic periodontitis will be evaluated.~   "
116445|NCT02043327|"~     The aim of this study is to create simulation-based tests with credible pass/fail-standards~     for two different fidelities of colonoscopy models~        1. virtual reality simulator~        2. physical model simulator To create pass/ fail standards for certification~   "
116446|NCT02043314|"~     The recommended treatment for latent tuberculosis infection for adults is a daily dose of~     isoniazid 300mg during 6 months. In Brazil, isoniazid was formulated as 100 mg tables. The~     treatment duration and the high pill burden compromised patient adherence to the treatment.~     The Brazilian National Programme for Tuberculosis requested the development of a new 300mg~     isoniazid formulation. The aim of the study is to compare the bioavailability of the~     isoniazid 300mg new formulation and three 100mg tablets of the reference formulation.~      The study is a randomized, single dose, open label, fasting, two-phase crossover~     bioequivalence study with a wash out period of 7 days (>7 half-life) in 28 healthy human~     volunteers. For the determination of isoniazid in human plasma, the investigators developed~     and validated a sensitive, simple and rapid HPLC-MS/MS method.~      This will support the strategy adopted by the Brazilian National Program for Tuberculosis for~     the treatment of latent tuberculosis. The new formulation will increase patients' adherence~     to the treatment and quality of life. Medical doctors in Brazil should become aware of the~     new formulation and the new treatment strategy in order to prescribe the right medication and~     avoid errors that could result in a high frequency of adverse events. Future research studies~     should evaluate pharmacovigilance, acceptability of the new tablet formulation and its impact~     on the cure rate.~   "
116447|NCT02043301|"~     This study aims to characterize the single dose pharmacokinetics of PF-04950616 following~     subcutaneous injection to the abdomen, upper arm or the thigh.~   "
116448|NCT02043288|"~     This clinical trial is designed to evaluate the impact of the addition of NC-6004 to~     gemcitabine in the treatment of patients with locally advanced or metastatic pancreatic~     cancer in Asian countires.~   "
116451|NCT02043249|"~     In the embry life there is a passage of IgG type, from the mother to tha embryoyo and only in~     the age of 3-5 month after birth the infant start to develop them by himself.~      In preterm infants the starting point of the level of the IgG's is lower from the level of~     term infants.~      Delayed cord clamping /milking it was prooved in many researches as benificial in terms of :~     levels of hemoglobin; hematocrit and feritin in the neonats. Also benefits were proved by~     means of less need for blood tranfusion, less intra ventricular hemorrhage; necrotzing entero~     colitis and iron deficiency anemia. The hypothesis is that delayed clamping /milking it will~     increse the level of IgG's in preterm infants. The end point hypothesis is that delayed cord~     clamping /milking cause to less fever disease or hospitalization it the neonats.~   "
116452|NCT02043236|"~     This is a phase II randomized controlled trial (RCT) of 2 strategies to improve bone health~     in men receiving androgen deprivation therapy (ADT).~   "
116453|NCT02043223|"~     The purpose of this study is to evaluate the effect of post-partum maternal vitamin A~     supplementation on breast milk bioactive compounds and immune status, growth and morbidity of~     children in the first four months of life.~   "
116454|NCT02043210|"~     The investigators are conducting a randomized clinical trial of our new web-based version of~     the CBT4CBT (Computer Based Training for Cognitive Behavioral Therapy) in Spanish. This~     program specifically designed for Spanish-speaking substance users to evaluate its~     effectiveness relative to standard outpatient counseling at the Hispanic Clinic. The~     computer-based training program (CBT4CBT) focuses on teaching basic coping skills, presenting~     examples of effective use of coping skills in a number of realistic situations in video form,~     and providing opportunities for patients to practice and review new skills while receiving~     substance use treatment.~   "
116455|NCT02043197|"~     Prospective, multicenter, non-comparative, observational program to describe prevalence of~     depressive symptoms in a variety of neurological disorders and effects of Fevarin® on the~     severity of anxiety and depression, sleep state, and cognitive function.~   "
116456|NCT02043184|"~     Improving Adherence to Oral Cancer Agents and Self Care of Symptoms Using an IVR The goals of~     this study are to improve adherence to oral chemotherapeutic medications and self-management~     of symptoms among cancer patients. More than 40 oral agents currently are on the market with~     projections that in three years 30% of the cancer treatment agents will be delivered in oral~     form. As a result, patients must assume responsibility for taking medications and~     self-management of associated side effects.~      This longitudinal randomized trial tests and compares 'two strategies' for improving patient~     adherence to their oral cancer medication prescriptions to standard care. Both strategies~     incorporate symptom management support using an interactive voice response system (IVR) for~     symptom assessment and a printed evidence-based Medication Management and Symptom Management~     Toolkit (Toolkit) with helpful strategies and information for symptom management.~      We will collaborate with NCI Comprehensive Cancer Centers to recruit patients into this~     study. Recruiters will identify patients as they are prescribed oral cancer medications,~     present the study to the patient, and ask them to consent to be part of the study.~      Study Aims Following are the Aims of the study.~        1. Cancer patients assigned to the intervention will have greater adherence to their~          prescribed regimen: a) at week 4 (immediate effect), and b) at weeks 8 and 12 (sustained~          effect).~        2. When compared with patients receiving weekly assessments only, patients receiving weekly~          assessments plus daily adherence reminders and printed symptom management strategies for~          4 weeks will report: lower symptom severity during weeks 2-4 that will be sustained at~          weeks 5-8, and at 12 weeks.~      Two exploratory aims are assessed:~        1. To test how patient characteristics (age, sex, depression), dose variation, symptom~          severity, and concurrent infusion therapy moderate the impact of the novel intervention~          on adherence at 4, 8, and 12 weeks.~        2. To test the impact of the novel intervention on dose alterations, emergency department~          visits and hospital admissions over the 12 weeks in order to support the translation of~          this system into oncology practices.~   "
116457|NCT02043171|"~     Men and women lose muscle mass and strength with age. Loss of muscle mass and strength is~     accompanied by a loss of muscle function which can lead to diminished quality of life and~     more importantly can lead to serious fall requiring medical treatment. The investigators~     hypothesize that the combined supplements of Calcium-HMB and Vitamin D will lead to decreased~     falls and to improved quality of life (QOL) for older adults. The investigators further~     hypothesize that the addition of a modest exercise regimen to these supplements will enhance~     the synergistic effects of both Calcium-HMB and Vitamin D.~      Subjects will consume the dietary supplement 2 times per day for 12 months. Tests will~     consist of the following: a) strength of subjects' legs and elbow by Isokinetic Dynamometer;~     b) body composition; c) hand-grip strength by hand-grip dynamometer; d) functional mobility,~     balance and agility (Get-Up and Get-Up-and-Go tests); e) filling out questionnaires; and g)~     having blood drawn for biochemical measurements. Testing will be performed at the baseline (0~     months) and at 3, 6, 9, and 12 months.~   "
116458|NCT02043158|"~     The goal of this research study is to learn about diet and exercise habits, emotions, and~     social support in the lives of women with ovarian cancer.~   "
116459|NCT02043145|"~     This post marketing surveillance study in Korea will evaluate the safety and efficacy of~     BOTOX (botulinum toxin Type A) in patients who receive treatment according to standard of~     care for primary axillary hyperhidrosis, focal spasticity or moderate to severe glabellar~     lines in clinical practice.~   "
116460|NCT02043132|"~     To the Investigators' knowledge, TXA has not been studied in the setting of reverse total~     shoulder arthroplasty. We propose a double-blinded, randomized, controlled trial comparing~     perioperative administration of TXA to placebo in the setting of RTSA. The purpose of this~     study is to examine the efficacy of TXA in reducing overall blood loss and transfusion rates~     in patients undergoing reverse total shoulder arthroplasty.~   "
116472|NCT02042976|"~     The purpose of the study is to determine the efficacy of mindfulness-based cognitive therapy~     (MBCT) as an add-on to pulmonary rehabilitation (treatment as usual, TAU) in chronic~     obstructive pulmonary disease (COPD).~      The investigators hypothesize that compared to treatment-as-usual, the add-on of MBCT will~     result in improved psychological (anxiety, depression) and physical outcomes (physical health~     status, activity level, inflammatory markers). Furthermore, the investigators will explore~     the possible moderating role of individual differences in sociodemographic and~     disease-related characteristics and the perceived quality of the therapeutic alliance, as~     well as the mediating role of mindfulness, breathlessness catastrophizing, self-efficacy, and~     self-compassion for the hypothesised effect.~   "
116473|NCT02042963|"~     KNOW-KT (KoreaN cohort study for Outcome in patients With KT: A 9-year Longitudinal cohort~     study of the Korean adult KT patients), funded by Korea Center for Disease Control and~     Prevention (KCDC) was established in 2012 by a group of transplant physicians, transplant~     surgeons, nephrologists, epidemiologists, and biostatisticians in Korea.~      We aimed to establish an adult KT cohort, to investigate the renal allograft outcomes,~     mortality, complications, and to explore traditional or nontraditional risk factors for~     morbidity and mortality. We established a bio-bank to integrate clinical and biological~     information. Here, we report design and method of the KNOW-KT.~   "
116461|NCT02043119|"~     Currently, healthy mothers willing to breastfeed their babies are discharged from the~     hospital on an average 2 days after a vaginal delivery or 3.5 days after a C-section, at a~     time where breastfeeding is far to be well established. Following discharge, women can access~     breastfeeding support from Public Health Units, lactation consultants, health care providers,~     and Internet (e.g. from breastfeeding associations). Despite the current support, duration~     and exclusivity rates of breastfeeding drop precipitously in the first weeks and months after~     birth.~      We have obtained funding from the Ontario Ministry of Health and Long Term Care to evaluate~     the efficacy and cost effectiveness of a post-partum clinic based in the community. This~     clinic, staffed by a family physician (in the morning), a registered nurse and a lactation~     consultant, will provide breastfeeding support during the first month after delivery as well~     as ensure a safe transition from hospital to the community for mothers and newborn babies.~     The clinic, affiliated with TOH, will be found at Harmony Medical Centre, 152 Cleopatra~     Drive, located south-west of downtown, a 15 minute drive from the Civic campus and 20 minutes~     from the General campus. The Harmony Clinic has abundant parking (free on the street or a~     small fee inside the associated lot) and is fully accessible.~      In its initial phase, the future clinic would enroll only women willing to participate in a~     research program to evaluate this new program. The clinic will be opening in November 2013~     and currently (July - October 2013) we are conducting a pilot study to test feasibility of~     recruitment and test the surveys and database for this project. Women will be recruited at~     the Ottawa Hospital (General and Civic campus) and randomized to either receive standard-care~     or to be given access to the post-partum clinic and be discharged within approximately 24~     hours following a vaginal delivery or 48 hours following a C-section. They will have an~     appointment booked at the breastfeeding clinic within 48 hours after discharge for maternal~     and neonatal care as well as breastfeeding support. Enrolled women will have access to~     additional clinic visits for one month after delivery. Information will be collected from~     their medical chart as well as through surveys that will be sent to them at 15 days, 30 days~     and 3 months after delivery. We will compare the data and information on the experience of~     women who attended the breastfeeding clinic and those who did not attend the clinic. With~     this data we will be able to determine if this type of breastfeeding clinic is beneficial to~     new mothers and their newborn babies and if it really does increase the exclusive~     breastfeeding rate at 3 months (primary outcome).~   "
116462|NCT02043106|"~     Participants will be asked to complete three different tests (standing, stepping and assisted~     walking) and will experience three different experimental conditions during each test. The~     three conditions are types of vibratory plantar cutaneous stimulation, which include no~     vibratory stimulation, submaximal vibratory stimulation and supramaximal vibratory~     stimulation. In the first condition, participants will experience no stimulation applied to~     any part of the body. In the second condition, a submaximal vibratory stimulus will be~     delivered at 90% of the participant's threshold to the surface of the foot. In the third~     condition, a supramaximal vibratory stimulus will be delivered at three times the~     participant's threshold. The hypothesis is that this plantar stimulation (90% threshold and~     supramaximal) will elicit increased muscle activity during these tests. If the hypothesis is~     positive then this protocol will also be presented in incomplete spinal cord injuried~     participants.~   "
116463|NCT02043093|"~     The purpose of this study is to evaluate the impact of the school-based Sources of Strength~     program in reducing suicidal behaviors in the population of high school students and~     determine how the program works (mechanisms of change). Sources of Strength trains diverse~     high school students as Peer Leaders, who conduct school-wide prevention messaging activities~     with ongoing adult mentoring designed to increase positive coping norms and practices,~     help-seeking and increase youth-adult connections. Sources of Strength is expected to enhance~     school coping practices, increase help-seeking among distressed and suicidal youth, and~     reduce the number of students in the population who attempt suicide. A total of 40 high~     schools in primarily rural and micropolitan regions of New York State and North Dakota will~     participate in this study that uses a randomized wait-listed design.~   "
116464|NCT02043080|"~     This is a study to evaluate Xpert MTB/RIF as the first-line TB diagnostic test in~     HIV-infected adults and pediatric patients as a means to obtain faster, more accurate TB~     diagnosis.~   "
116465|NCT02043067|"~     This study will examine an enhanced protocol to systematically screen a cohort of 400 new HIV~     clinic enrollees for prevalence and 1-year incidence of tuberculosis (TB).~   "
116466|NCT02043054|"~     There are recent advances in therapies for the treatment of Type 2 Diabetes Mellitus (T2DM)~     which include the GLP1 analogues and the DPP IV inhibitors. Both of these therapies target~     the incretin system using different methods to elevate/maintain circulating levels of GLP1 to~     subsequently achieve improved blood sugar control. Interestingly, GLP1 analogues have been~     reported not only to improve blood sugar control but to additionally induce weight-loss and~     emerging experimental evidence has shown it may have beneficial effects on the heart's~     structure and function. Due to the profile of this condition being a lot worse and younger~     patients having greater CVD risk, a therapy offering multiple positive effects, in particular~     the potential cardiometabolic effects, make this line of therapy attractive in this patient~     population.~      The aim of this research is to investigate the cardiometabolic effects of Liraglutide (GLP1~     analogue) compared to that of its clinically relevant comparator Sitagliptin (DPP IV~     inhibitor).~   "
116467|NCT02043041|"~     We will invite a convenience sample of up to 45 enrolled subjects to participate in an~     optional, self-administered blood specimen collection procedure to determine optimal~     procedures for collection.~   "
116468|NCT02043028|"~     To perform chest compression (CC) in the kneeling posture in hospital, we designed a stage~     with stairs, named the 'kneeling stool', on which a CC performer kneels beside a patient on a~     bed.This work is the validation study to demonstrate that the kneeling stool could be used~     for high quality hospital cardiopulmonary resuscitation (CPR) with the kneeling posture. We~     hypothesized that the quality of chest compression with a kneeling posture using the kneeling~     stool is equal to or superior to CC with a standing posture using the height adjustment~     mechanism of the bed.~   "
116469|NCT02043015|"~     The purpose of this study is to evaluate the acceptability and uptake of a combination~     package of biomedical, behavioral and community-level HIV prevention interventions and~     services for men who have sex with men (MSM) in South Africa.~   "
116470|NCT02043002|"~     Erlotinib, an anti-cancer agent targeting the epidermal growth factor receptor (EGFR), is an~     active treatment of patients with non-small cell lung cancer (NSCLC). Effect of treatment is~     primary seen in patients harboring a mutation in the EGFR. However, 10-15% of patients does~     not harbor a mutation but respond as well. Identifying these patients is a problem and~     methods are lacking.~      Studies have shown that an early 18F FDG-PET might can predict response and outcome in these~     patients, but further studies are needed to confirm these findings.~   "
116471|NCT02042989|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of MLN9708 and vorinostat that can be given to patients with advanced solid~     tumors. The safety of these drugs will also be studied.~   "
116474|NCT02042950|"~     The goal of this clinical research study is to learn if carfilzomib can help control relapsed~     or refractory MCL. The safety of this drug will also be studied.~   "
116476|NCT02042924|"~     This is a pilot sub-study of patients receiving myeloablative transplant using total body~     irradiation (TBI) or total marrow irradiation (TMI) in their preparative regimen. The~     objective of this stub-study is to estimate the heterogeneity in cellular proliferation~     (FLT-PET uptake) as well the heterogeneity in marrow composition distribution (measured using~     whole body water-fat MRI) using positron emission tomography imaging. This will be used to~     design future trials as well as to determine the feasibility of PET and MRI imaging.~   "
116477|NCT02042911|"~     The purpose of this study is to investigate safety and efficacy of SyB L-0501 after 2-day~     intravenous infusion at a dose of 100 mg/m2/day to patients with chronic lymphocytic~     leukemia.~   "
116478|NCT02042898|"~     TRICS-III is an international, multi-centre, open-label randomized controlled trial of two~     commonly used transfusion strategies in high risk patients having cardiac surgery using a~     non-inferiority trial design.~   "
116479|NCT02042885|"~     The purpose of this study is to determine the tolerability profile of OPB-111001 and to~     determine the most suitable dose of OPB-111001 in patients with advanced cancer~   "
116480|NCT02042872|"~     In subjects with acute SCI: To compare the effects of parenteral zoledronic acid therapy on~     preservation of regional and total skeletal mass (DXA).~      Hypothesis: Zoledronic acid will dramatically diminish bone loss in persons with acute SCI,~     as evidenced by serial densitometry determinations (DXA).~   "
116481|NCT02042859|"~     The purpose of this study is to determine whether the use of an FDA approved endoscopic~     bipolar catheter (EndoHPB) will ablate tissue in malignant tumors within the pancreatic~     ducts.~   "
116482|NCT02042846|"~     The SportWelding FijiAnchor is an absorbable suture anchor which is inserted by applying~     ultrasonic energy. This provides an intimate bond between implant and bone delivering~     immediate stability.~      The purpose of this study is to evaluate the surgical and clinical outcome of the~     SportWelding Fiji Anchor in ligament repair of the hand and hand wrist.~   "
116483|NCT02042833|"~     This observational study will evaluate patients' perception of treatment with~     erythropoiesis-stimulating agents in patients with chronic kidney disease not on dialysis.~     Eligible patients initiated on treatment with Mircera (methoxy polyethylene glycol-epoetin~     beta) will be followed for 6 months.~   "
116484|NCT02042820|"~     In vivo confocal microscopy (IVCM) is a sensitive imaging tool for detecting dry~     eye-associated subclinical inflammation. Studies have previously shown that IVCM provides an~     in vivo metric to measure inflammatory changes in the central cornea. The objective of the~     current study is to assess inflammatory response changes in the peripheral cornea and the~     conjunctiva by analyzing epithelial immune cell density and morphology in these areas and~     then correlating the IVCM findings to clinical signs and symptoms to establish novel~     objective imaging biomarkers.~   "
116485|NCT02042807|"~     To evaluate the effect of MCS® compared with placebo in reducing the risk of~     biopsy-detectable prostate cancer in high-risk subjects after 104 weeks (24 months) of~     treatment.~   "
116486|NCT02042794|"~     Liver resection is an operation to remove the diseased part of the liver. The liver is~     supplied by two vessels, the hepatic artery and the portal vein supplying 25% and 75%~     respectively of the total blood flow with 50% oxygen from each vessel. During liver resection~     it is standard practice to clamp both vessels(Pringle's manoeuvre), so as to avoid bleeding.~     Clamping both the vessels deprives the unaffected liver from nutrients required for survival.~     Reinstating the blood supply causes further damage by pouring harmful substances into the~     liver, which accumulate during the clamping. We hypothesize that not clamping the oxygen rich~     hepatic artery will cause less damage to the liver.~      Our aim is to compare the Pringle manoeuvre with portal vein clamping, to identify if the~     latter will result in less tissue injury and thereby fewer complications. Initially we aim to~     conduct a pilot study. The main objective is to ensure that patients can be successfully~     recruited and that data capture is complete. The secondary outcomes will be development of~     infective complications by 30 days following surgery, bleeding and blood transfusion~     requirements, heart/chest complications, recovery of liver functions, growth of remnant~     liver, death within 30 days following surgery, length of high dependency unit/hospital stay~     and quality of life at 3 months after surgery.~      There is published literature on the safety of this method and in the event of any~     intraoperative problems, the procedure will be converted to the standard Pringle manoeuvre.~     The Liver Unit at St James's University Hospital has four surgeons performing around 270~     liver cancer resections per year, of which nearly 160 are for bowel cancer spread.~     Considering the team's experience in research and liver surgery, we believe it is well placed~     to conduct the trial in a safe and efficient manner.~   "
116487|NCT02042781|"~     This Phase Ia study aims to establish the maximum tolerated dose of once-weekly IV infused~     PG545 and to evaluate its safety in subjects with advanced solid tumours. In addition, the~     study will explore whether PG545 exposure results in changes to chemicals produced by the~     body that are associated with cancer growth and spread.~   "
116488|NCT02042768|"~     Peritoneal Dialysis (PD) is a commonly used treatment for end stage renal failure, and the~     most commonly used dialysate contains unphysiological amounts of glucose, a high proportion~     of which is absorbed. Recent analysis of the Global Fluid Study, has established that in~     non-diabetic prevalent patients on PD a random glucose level is dependent on dialysate~     glucose load and is a predictor of death. By utilising clinical data and additional~     biosamples collected for the NIHR funded PD-CRAFT study, the investigators aim to confirm~     this finding, define the relationship between dialysate glucose exposure according to~     prescription regimes and glycaemia, define the most useful biomarker to monitor glycaemia ,~     and establish the role that impaired insulin sensitivity plays in blood glucose levels.~     Furthermore the investigators will explore the hypothesis that insulin resistance is~     associated with disturbance of the carnitine/acetyl-carnitine equilibrium that might benefit~     from intra-peritoneal carnitine supplementation.~      PD-CRAFT is an observational cohort study of 3000 prevalent PD patients collecting detailed~     clinical data, including glucose exposure and samples of dialysate. and blood which will be~     stored in the UK BioCentre. Follow up is for up to 2 years or endpoint (death, technique~     failure).~      Multivariate regression will be used to establish determinants of the non-fasting blood~     glucose and other measures of glycaemia, in particular different dialysis regimes, (e.g.~     modality, dwell lengths, fill volumes, and dialysate type and concentration specifically~     seeking to identify prescriptions that minimise the systemic effects) combined with measures~     of insulin resistance. The investigators will establish whether blood glucose predicts~     survival in an adjusted analysis (~300 endpoints needed) using Cox regression and explore the~     relationship of other biomarkers to survival.~   "
116489|NCT02042755|"~     The principal objective of the study is to determine the visual acuity at far, intermediate~     and near distances tested with optotypes at different distances from the eyes and tested with~     defocus addition lenses of patients implanted bilaterally with the POD 26P AY FineVision.~      Secondary objective will be to test the glare and contrast sensitivity.~   "
116604|NCT02041234|"~     Investigators aim to show that Roux-en-Y Gastric Bypass (RYGB) is superior to best medical~     treatment in reaching well-defined treatment end points in Asian subjects of BMI 27-32 with~     type 2 Diabetes (DM2). Investigators also hope to show that successful RYGB will reduce~     resource utilization in the near term with similar projected reduction over the medium to~     long term.~   "
116490|NCT02042742|"~     A crossover trial was carried out in healthy volunteers aged 45-70 years and BMI <30 kg/m2.~     Subjects consumed a Antioxidant Supplement (AS) containing 65 mg of punicalagin mixed with~     3.3 mg of hydroxytyrosol 3 times daily or a Control Supplement (CS) with maltodextrin for an~     8 wk each phase with 4-wk rest period. Supplementation order was randomly assigned and the~     consumption of derivative products of punicalagin and/or hydroxytyrosol restricted. The~     endothelial function parameters (brachial artery flow-mediated dilation (FMD), biochemical~     markers), inflammatory markers and nutritional status were evaluated before and after each~     phase. Previously a pilot study was completed with no placebo (n=30) to determinate the~     effective dose of Functional Supplement.~   "
116491|NCT02042729|"~     The purpose of this study is to investigate the safety and pharmacokinetics of new patch~     formulation (tape) of E2022 by conducting patch test.~   "
116492|NCT02042716|"~     Preterm birth and perinatal events related can interrupt microscopic maturation of the~     developing white matter leading to diffuse injury and subsequent neurocognitive impairments.~     Brain maturation can be studied using diffusion tensor imaging but is difficult to assess~     early after birth, repeatedly and at the bedside. Supersonic Shear wave Imaging (SSI) could~     be of interest in this clinical setting. This technique, already investigated in adults~     (breast, thyroid or liver fibrosis staging), has not been yet evaluated in neonates.~      Objective:~      To describe the feasibility and reproducibility of quantitative elasticity mapping in preterm~     infants and to correlate to gestational age.~      Methods:~      SSI is a quantitative stiffness imaging technique based on the combination of a remote~     palpation induced into tissues by the radiation force a focused ultrasonic beam and an~     ultrafast ultrasound imaging sequence. Such ultrafast frame rates permit to track in real~     time the displacements induced by the propagation of the resulting shear waves. For each~     pixel, the shear wave speed can be estimated locally and enables quantitative mapping of the~     local shear elasticity (characterizing the stiffness in kPa). In this study, we will use a~     new generation of ultrafast ultrasound scanners (Aixplorer®, Supersonic Imagine, Aix en~     Provence, France) with a linear L10-2 probe (256 elements, 6 MHz) in neonates born between 25~     and 40 weeks' gestation (n=100). Three separate acquisitions will be obtained for each area~     of interest both on right and left sides and stiffness was measured using a unique ROI of 2.5~     cm².~   "
116493|NCT02042703|"~     The purpose of this study is to use a special eye imaging technique, anterior segment optical~     coherence tomography (AS-OCT), to image the lens (the curved, transparent part of the eye~     that helps you to see clearly by directing images of light onto the back of your eye) and~     note any changes in exfoliation syndrome. Exfoliation syndrome is a common condition that has~     many ways of showing up in the eye, including the formation of deposits in the eye, shakiness~     of the lens that can complicate cataract surgery, and a higher chance of developing a type of~     glaucoma called exfoliation glaucoma. In this study we plan to collect images and measure~     exfoliation deposits on the lens with AS-OCT, which can take high resolution pictures of the~     eye without requiring contact with the eye. We will compare lens images of subjects with~     exfoliation syndrome to those of subjects with primary open angle glaucoma and cataracts.~     This type of imaging could be used in patients with known diagnosis of exfoliation syndrome~     to track disease progression and see how they respond to possible treatments. We also hope~     that with this imaging technology we can detect early changes in currently unaffected eyes,~     which could be useful for predicting which patients may develop the disease.~   "
116494|NCT02042690|"~     The survival of adult patients with standard-risk acute lymphoblastic leukemia(ALL) need to~     improve. We want to compare the efficacy of haplo-identical hematopoietic stem cell~     transplantation (HSCT) with chemotherapy for adult(age:18-39 years old) ALL patients in first~     phase of complete remission (CR1)~   "
116495|NCT02042677|"~     This evaluation is being conducted to determine user perception of a new flat one-piece skin~     barrier compared to their normal barrier.~   "
116496|NCT02042664|"~     Glucagon-like peptide-1 (GLP-1) receptor agonist are new treatment of type 2 diabetes, they~     lower blood glucose level (by enhancement of glucose-dependent insulin secretion and~     suppression of excess glucagon secretion) and reduce weight by inducing satiety and slowing~     of gastric emptying. Beneficial effects of GLP-1 and GLP-1 receptor (GLP-1R) agonists on~     cardiovascular function have been suggested. They improve biomarkers of CV risk, decrease~     systolic blood pressure, improve endothelial function and have beneficial effects on~     myocardium. Nevertheless, few studies have analysed the effect of GLP1 treatment on~     myocardial function in type 2 obese diabetic.~      Myocardial steatosis is an independent predictor of diastolic dysfunction in type 2 diabetes~     mellitus. It was recently shown that 16 weeks of caloric restriction in obese patients with~     diabetes decrease myocardial triglyceride content and improve myocardial function (cardiac~     output, normalized stroke volume, LV mass and normalized end diastolic volume), and diastolic~     function. However, no study has evaluated the impact of Glucagon-like peptide-1 (GLP-1)~     receptor agonist in obese diabetics on myocardial TG content.~      Recent studies have suggested that increased epicardial adipose tissue (EAT) could be an~     important risk factor for cardiac diseases. We and others have already evidenced a~     correlation between the volume of epicardial adipose tissue and the presence or the severity~     of coronaropathy. The impact of weight loss on the volume of EAT or the characteristics of~     EAT is mostly unknown.~   "
116505|NCT02042547|"~     Before la surgery:~      Transthoracic cardiac echography will be done systematically, to measure among other things~     the size of the left atrium.~      During surgery:~      Surgery under extracorporeal circulation: tissue samples will be harvested from the right~     atrium (one before clamping of the aorta (T0= pre-ischemia sample), immediately before~     declamping of the aorta (T1= post-ischemia sample).~      Surgery without extracorporeal circulation: tissue samples from the right atrium before CABG~     (T0) and a second sample after CABG (T1).~      In parallel with the harvesting of cardiac tissue, blood samples will be taken at different~     times (H0, H3, H24) to correlate tissue data with systemic data. These will be taken by the~     anesthetists.~      After the surgery:~      Holter ECG will be set up for 7 days of continuous recording. Each patient will fill in an~     observation notebook. The biological samples will be analysed immediately and the biological~     data obtained will be recorded in the observation notebook.~   "
117160|NCT02033980|"~     Recently, a new category classification (NICE classification) using non-magnified NBI has~     been proposed. We design this multicenter study to evaluate the reliability and validity of~     the NICE classification in diagnosing colorectal polyps by Chinese endoscopists during both~     image and real-time process.~   "
116497|NCT02042651|"~     Introduction:~      Chronic pelvic pain with unknown pathology is a condition that affects both men and women.~     the condition is defined as pelvic pain lasting for a minimum of 6 months without any known~     etiology eg. cancer, infection or inherent anatomical abnormalities. Low intensity~     extracorporeal shockwave therapy (LIESWT) enables the practitioner to deliver a small amount~     of energy approximately 5 cm under the skin of the patient without damaging the skin. This~     have been shown to increase blood flow and accelerate healing which could also be beneficial~     in chronic pelvic pain patients.The purpose of this study is to investigate the effects of~     LIESWT on chronic pelvic pain.~      Methods:~      All patients will be treated at the Birthe Bonde clinic, in Copenhagen, Denmark.~      The investigators anticipate to include 100 chronic pelvic pain patients in the study.~      included patients will be randomized into two groups: active treatment or sham treatment.~      All patients will be required to provide a urine sample and a semen sample prior to final~     inclusion. Samples will be analyzed for microbial growth. Furthermore, patients will undergo~     a digital rectal exploration and finally all patients is required to provide an informed~     consent in order to be included in the study.~      A Storz Doulith SD1 T-Top (CE1275) will be used to generate shockwaves. Patients will receive~     the treatment once a week until their symptoms have seized or for a maximum of 6 times. Each~     treatment consists of 3000 shockwaves applied to the perineum with a energy density of~     0.25-0.40 millijoule(mJ)/mm2 and a frequency of 3 hz.~      Participants will fill out a questionnaire one week before the treatment, one week, four~     weeks, and twelve weeks after the last treatment.~      Possible gains from this study:~      The investigators hope to provide further evidence for this treatment and consequently be~     able to offer the treatment as an alternative to the very limited array of treatments~     existing for this group of patients today.~      Ethics, funding, and publication:~      The study is performed in compliance with the Helsinki declaration. External funding have~     been applied for but not yet received. Participants will be informed of sources of external~     funding. The result of the study will be published as soon as possible, preferably in a~     peer-reviewed international journal.~   "
116498|NCT02042638|"~     Effects of hCG replacement therapy on metabolic syndrome parameters in hypogonadotrophic~     hypogonadism.~   "
116499|NCT02042625|"~     Low body temperature (hypothermia) is often observed in anesthetized patients. Mild~     hypothermia increases complications such as surgical blood loss, postanesthesia recovery and~     the duration of hospitalization. To assess body temperature and minimize hypothermia-related~     complications, it is important to have accurate and reliable methods of measuring~     intraoperative core temperature. Common practice is to insert a nasopharyngeal (back of the~     throat from the nose) probe through one of the nostrils. However, there is no consensus or~     guideline regarding how deep the nasopharyngeal probe needs to be inserted. This study is~     being done to determine the insertion depth (or range of depths) that best approximates core~     temperature, which is temperature of the vital organs, e.g. heart, liver and lungs.~      Participation in the trial will occur on the day of surgery. The subject will be asked to~     breathe through one nostril and then the other before receiving anesthesia. The less~     congested nostril will be selected for study. If there is no difference, then the~     investigator will use the right nostril.~      Once under anesthesia, an esophageal temperature probe will be inserted to serve as a~     reference core temperature, which is used routinely in surgery. Then the nasopharyngeal probe~     will be inserted into the nostril.~      Both nasopharyngeal and esophageal temperatures will initially be recorded 45 minutes after~     anesthetic induction. The nasopharyngeal probe will then be withdrawn 2 cm and after a~     3-minute equilibration period, nasopharyngeal and esophageal temperatures will again be~     recorded. The nasopharyngeal probe withdrawal sequence will be repeated, 2 cm at a time,~     until only 2 cm remains in the nostril. There will be a total of 10 sets of nasopharyngeal~     and esophageal temperatures obtained.~   "
116500|NCT02042612|"~     Describing a pharmacokinetic model of 48-h sevoflurane sedation in obese ICU patients~   "
116501|NCT02042599|"~     Describing a pharmacokinetic model of 48-h sevoflurane sedation in ICU patients with acute~     kidney failure~   "
116502|NCT02042586|"~     The investigators believe that the application of non-linear methods of analysis using the~     ganglion and neural network technique will make it possible to analyse all of the complex~     data obtained in patients with hip osteoarthritis before and then after total hip~     replacement, and should allow us to identify a combination of objective variables to classify~     the surgery as  successful  or  unsuccessful .~      To this end, the study will take place as follows:~      Step 1: Screening, and inclusion. Step 2: Evaluation of the hip osteoarthritis and analysis~     of locomotor activity Step 3: Total hip replacement Step 4: Clinical evaluation of locomotor~     activity carried out between 6 months and 1 year after the THR Step 5: Data analysis~   "
116503|NCT02042573|"~     Low frequency rTMS (repetitive Transcranial Magnetic Stimulation) for the treatment of~     patients with depression, is responsible for a decrease in the expression of the C-FOS and~     DUSP1 genes in peripheral blood leukocytes. The decrease in C-FOS expression could be~     explained by the inhibiting effect of low-frequency rTMS (in contrast, high-frequency rTMS~     causes activation of the cerebral cortex) [Rossi, 2009]. This genetic effect could correlate~     with the antidepressant effect [Hausmann, 2000].~      According to this hypothesis, the genetic effect related to medical antidepressant treatments~     deserves to be studied because we could observe:~        -  either a decrease in the expression of the C-FOS and DUSP1 genes related to the~          antidepressant effect of the medical antidepressant treatment,~        -  or an increase in the expression of the C-FOS and DUSP1 genes related to cerebral~          activation due to the medical antidepressant treatment.~      In summary, we wish to determine the validity of this hypothesis by comparing the genetic~     effect of rTMS with that of medical antidepressants to know if:~        -  this genetic effect is specific to rTMS or common rTMS and medical antidepressants~        -  this effect correlates with the clinical improvement induced by rTMS and by medical~          antidepressants~        -  this early modification in the C-FOS and DUSP1 genes may be predictor of the therapeutic~          response to rTMS and antidepressants (early decrease in gene expression)~        -  the absence of any decrease or increase in C-FOS and /or DUSP1 expression is a predictor~          of therapeutic resistance to rTMS and/or medical antidepressants.~   "
116504|NCT02042560|"~     Immune thrombocytopenia (ITP) is an autoimmune disease characterized by a low platelet count~     responsible for bleedings. The disease is mostly mediated by antiplatelet antibodies produced~     by specific B cells. However, T cells are also involved but their role is not completely~     understood.~      The aim of this study is to determine the implication of T cells in the pathogenesis of ITP,~     notably regulatory T cells (Treg, CD4+CD25highFoxp3+), cytotoxic T cells (CD3+CD8+) and T~     follicular helper cells (TFH, CD3+CD4+CXCR5+PD-1+ICOS+), in blood and in the spleen of~     primary ITP patients, compared to healthy controls.~   "
116571|NCT02041663|"~     Use of brain natriuretic peptide to evaluate the cardiac function in the course of~     meningococcal septic shock or severe sepsis.~   "
116572|NCT02041650|"~     This protocol describes a pilot study intended to test the hypothesis that patients with~     acute coronary syndrome (ACS) caused by plaque erosion can be stabilized by effective~     antithrombotic treatment without stent implantation, thereby avoiding both early and late~     complications related to percutaneous coronary intervention (PCI).~   "
116506|NCT02042534|"~     Rationale Acute ischemic stroke due to atrial fibrillation (AF) carries a high risk for early~     recurrence. In acute stage, guidelines recommend aspirin, but do not recommend~     anticoagulation due to the increased risk of intracranial bleeding. Since, aspirin has a~     limited efficacy of preventing recurrent stroke in AF, expert consensus suggests early~     anticoagulation in non-severe stroke with AF. The current practice for acute ischemic stroke~     patients with AF is delayed warfarin administration with aspirin use for non-minor stroke or~     immediate warfarin administration (sometimes with heparin bridging) for minor stroke.~     However, conventional anticoagulation with warfarin in acute ischemic stroke with AF has the~     following limitations: 1) risk of intracranial bleeding particularly in acute stage, 2)~     delayed action and transient paradoxical thrombogenic tendency due to the inhibition of~     protein C, resulting in the risk of early recurrent embolic stroke, and 3) prolongation of~     hospitalization waiting for full anticoagulation. In contrast, as compared to warfarin,~     rivaroxaban is advantageous for reduced risk of intracranial bleeding and immediate~     anticoagulation efficacy.~      Goal The current trial will examine whether early initiation (within 5 days from stroke~     onset) of rivaroxaban as compared to conventional warfarin would reduce intracranial~     bleeding, recurrent embolic stroke, and hospital stay in patients with acute ischemic stroke~     due to AF.~   "
116507|NCT02042521|"~     The purpose of this study is to determine whether a dietary supplement (DS) is effective in~     protecting against sad mood during early cigarette withdrawal. This study will also assess~     whether the dietary supplement will be well tolerated during early cigarette withdrawal.~   "
116508|NCT02042508|"~     This single-centre study was carried out in collaboration with the Cardiovascular Research~     Laboratory of Harvard University (Boston, USA). This preliminary study does not include a~     control group.~      The aim of this study was to investigate the effect of a hybrid reconditioning programme~     (electrostimulation of the lower limb muscles associated with voluntary strengthening of the~     upper limbs) on a specially developed rowing machine in patients presenting stabilized~     paraplegia of a traumatic origin. This study will bear on the increase in maximal aerobic~     capacity (VO2max) between the start and end of the 9-month reconditioning programme.~   "
116509|NCT02042495|"~     The investigators will explore the chemopreventive role of metformin. The purpose of this~     study is to determine whether, among patients with endometrial cancer, treatment with the~     currently approved insulin sensitizing drug metformin increases or decreases pathway~     activation distal to the insulin receptor in endometrial cancer tissue. This is a phase IIa~     study of metformin to be used to the pre-operative period of women diagnosed with endometrial~     cancer by comparing their endometrial biopsy specimens taken at their initial visit and after~     4-6 weeks of treatment of metformin on the day of their surgical staging.~   "
116510|NCT02042482|"~     The purpose of this study is determine whether combination Q10 , L-carnitine and multivitamin~     and mineral complex is effective in treatment of patients with low and intermidiate1-2 risk~     Myelodysplastic syndrome~   "
116511|NCT02042469|"~     Enrollment of patients in CR may be impacted by their levels of awareness and attitude toward~     participation. Our study aims at assessing the awareness and willingness to participate in CR~     and identifying the barriers and influencing factors for participation.~      A cross-sectional study was performed using an interview-based questionnaire composed of~     close-ended questions conducted by trained research coordinators. Descriptive statistics,~     univariate and multivariate analyses were applied.~   "
116512|NCT02042456|"~     This study is investigating whether automated whole breast ultrasound can improve detection~     of cancer in breast cancer screening when used as a supplement to mammography or as a~     supplement to digital breast tomosynthesis~   "
116513|NCT02042443|"~     This randomized phase II trial studies how well trametinib or combination chemotherapy works~     in treating patients with refractory or advanced biliary or gallbladder cancer or that cannot~     be removed by surgery. Trametinib may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil, leucovorin~     calcium, and capecitabine, work in different ways to stop the growth of tumor cells, either~     by killing the cells, by stopping them from dividing, or by stopping them from spreading. It~     is not yet known whether giving trametinib is more effective than combination chemotherapy in~     treating patients with biliary or gallbladder cancer.~   "
116514|NCT02042430|"~     This pilot clinical trial studies epacadostat before surgery in treating patients with newly~     diagnosed stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer.~     Epacadostat may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth.~   "
116515|NCT02042417|"~     We compare two POC-tests (INRario2 and CoaguChek) for the INR with the laboratory. Therefore,~     we take bloodsamples (capillary and venous blood) and put it on the tool. After the~     measuring, a number is shown = INR.~      We develop a Bland-Altman-plot for the correlation between the tool value and the laboratory~     value to illustrate the applicability in the clinical daily routine.~   "
116516|NCT02042404|"~     The EarLens System is an assistive hearing device that is intended to provide amplification~     for the treatment of patients with sensorineural hearing impairment. The purpose of this~     multi-center definitive study is to assess the safety and efficacy of the EarLens System for~     subjects with bilateral mild to severe sensorineural hearing impairments wearing the fully~     activated system in their daily lives for a 4 month period of time. This study is designed to~     support US and International marketing applications to commercialize the EarLens System. The~     main efficacy hypothesis is that the EarLens System will be shown to improve speech~     understanding in quiet.~   "
116517|NCT02042391|"~     Post-transplant lymphoproliferative disorders (PTLD) differ clinically from lymphoma in the~     general (immunocompetent) population due to their higher incidence and their frequent~     association with Epstein-Barr virus. Previous clinical trials have shown their remarkably~     good response to rituximab as well as to chemotherapy.~      The PTLD-1 trial demonstrated the efficacy and safety of sequential immunochemotherapy with 4~     courses of rituximab IV followed by 4 cycles of CHOP chemotherapy. Compared to trials of~     rituximab monotherapy in PTLD, median overall survival was extended from 2.4 to 6.5 years.~     Compared to previous trials of chemotherapy, complications were reduced. In addition, we~     noted that those patients who already had a good response to the first four cycles of~     rituximab did better overall than those who did not. As a consequence, the PTLD-1/3 trial~     introduced risk-stratification in sequential treatment according to the response to the first~     4 courses of rituximab monotherapy. Those patients with a complete remission went on to~     receive four further courses of rituximab whereas those who did not received rituximab and~     CHOP chemotherapy. Interim results have demonstrated that it is safe to restrict chemotherapy~     treatment in this manner and thus established the concept of treatment stratification based~     on the response to rituximab.~      The PTLD-2 trial is the next step in the development of this strategy. Compared to the~     PTLD-1/3 trial, the key difference is the use of subcutaneous instead of intravenous~     rituximab application. Interim results from an ongoing trial of patients with follicular~     lymphoma (NCT01200758) have shown that subcutaneous administration results in increased blood~     levels and in non-inferior remission rates. Furthermore, the stratification strategy is~     refined based on observations from the previous PTLD-1 and PTLD1/3 trials: Risk groups are~     now defined not only based on response to rituximab therapy but also on the international~     prognostic index (IPI, a well-established lymphoma risk score) and the transplanted organ.~     The major advantage of this new stratification is an extended low-risk group that is eligible~     for subcutaneous rituximab monotherapy: Patients with a low risk of disease progression,~     defined as those who achieve a complete remission after the first four courses of~     subcutaneous rituximab monotherapy and those with an IPI of 0 to 2 who achieve a partial~     remission at interim staging, will go on with rituximab monotherapy. Patients with high IPI~     who achieve a partial remission, patients with stable disease at interim staging and~     non-thoracic transplant recipients with progressive disease at interim staging will be~     considered high risk. These patients will go on with 4 cycles of rituximab plus CHOP~     chemotherapy similar to the PTLD-1/3 protocol. Thoracic transplant recipients refractory to~     rituximab will be considered very high risk and will go on with rituximab subcutaneous plus~     alternating chemotherapy with CHOP and DHAOx.~      The trial hypothesis is that the new protocol will improve the event-free survival, a measure~     integrating unfavorable events such as death, disease progression and treatment~     complications, particularly infections, in the low risk-group compared to the results of the~     PTLD-1 trial. In very high-risk patients data from the PTLD-1 and PTLD-1/3 trial have shown~     that the current treatment is not sufficient to control the disease. Death due to disease~     progression was observed in more than 80% of patients. Here, rituximab combined with~     alternating chemotherapy cycles of CHOP and DHAOx (+GCSF) may increase treatment efficacy~     with an acceptable toxicity profile.~      In summary, the PTLD-2 trials tests if the substitution of subcutaneous for intravenous~     rituximab and an updated stratification strategy that deescalates treatment for those at low~     risk and escalates treatment for those at very high risk can further improve the overall~     efficacy and safety of PTLD therapy.~   "
116518|NCT02042378|"~     The purpose of this study is to determine whether oral rucaparib is effective in the~     treatment of patients with locally advanced or metastatic pancreatic cancer and a known~     deleterious BRCA mutation.~   "
116519|NCT02042365|"~     The primary purpose of the study is to test the feasibility of a protocol of enhanced~     recovery after surgery for reducing the total length of hospital stay in a large scale~     setting~   "
116520|NCT02042352|"~     The primary aim of the present study is to investigate the vaginal microbiota of infertile~     women with two novel molecular based diagnostic tests for Bacterial Vaginosis, a PNA FISH and~     a PCR method supported with conventional Gram staining.~      We hypothesize that the molecular based tests will prove more efficient than conventional~     Gram staining and that they have a place in future IVF diagnostics.~   "
116521|NCT02042339|"~     Hyperbaric oxygenation (HBO) involves breathing of 100% oxygen under elevated ambient~     pressure. In correlation to the pressure level oxygen dissolves in the plasma resulting in an~     increase of total oxygen in the body. The elevated tissue levels of oxygen may persist for~     hours, instigating healing processes in wounds caused by disturbances in of perfusion in~     small vessels, a condition often found in patient with diabetes.~      We plan a prospective, double-blind randomized clinical study in 80 patients with chronic~     diabetic ulcer. All will have optimum treatment of diabetes. The HBO group will be given HBO~     at 2.4 bar, 90 min., 30 sessions, controls will have sham HBO. Routine wound care will be~     identical in both groups. Before, during and after treatment (3, 6 and 12 months), a number~     of monitoring and imaging procedures will be done, cells in the bloodstream indicating~     improved healing will be determined.~      Hypothesis: HBO will instigate the healing process in the majority of patients with chronic~     diabetic leg ulcer, provided the patency of the large vessels is given.~   "
116522|NCT02042326|"~     The aim of the study is to evaluate the efficacy and safety of sirolimus (oral form), to~     decrease the volume and symptoms due to superficial arteriovenous malformations (AVM).~      Sirolimus has properties that reduce the activity of the immune system (immunosuppressant),~     to fight against the proliferation of cancer cells (anti- tumor) and also reduce the~     proliferation of blood vessels (anti -vascular). Sirolimus is primarily used in transplant~     patients to prevent organ transplant rejection. Many animal and laboratory studies were~     carried out and demonstrate in particular the activity of sirolimus on vessels. It is this~     anti- vascular effect that could help treat arteriovenous malformations.~   "
116523|NCT02042313|"~     Esophagectomy is a major surgical procedure often associated with significant morbidity and~     mortality and significant level of postoperative pain. In contrast to open esophagectomy~     where epidural pain control has been considered as a gold standard and could be crucial in~     affecting outcome the analgesic scheme for minimally invasive esophagectomy (MIE) is yet to~     be established. We would like to compare continuous epidural analgesia and continuous~     paravertebral block combined with single shot subcostal transversus abdominis plane (TAP)~     block in the analgesic effects, levels of cytokines, and postoperative complications in~     patients receiving MIE.~   "
116524|NCT02042300|"~     The purpose of this study is to evaluate effectiveness and safety of XIENCE xpedition/Alpine~     in Routine Clinical Practice~   "
116525|NCT02042287|"~     Bacterial vaginosis (BV) is the most common cause of vaginitis in women of childbearing age.~     Women with symptomatic BV may present with malodorous discharge that is off-white, thin, and~     homogenous and has a fishy smell especially after intercourse. It is of importance to treat~     women with BV, as this condition is associated with serious risks, such as an increased risk~     of preterm birth in pregnant women, and particular vulnerability to the acquisition of~     sexually transmitted disease (STD). The pathophysiology of BV consists of changes in the~     microbiologic composition of the vaginal flora. The treatment of choice for BV is oral~     metronidazole for 7 days. Although the available antibiotic therapies produce good results in~     the short term, symptomatic BV persists or recurs at 3 months in up to 50% to 70% of~     patients, with long-term recurrence approaching 85%. An alternative treatment option may be a~     vaginal acid gel which aims to optimize the vaginal milieu. The aim of this pilot study is to~     assess the efficacy of Gynofit® vaginal gel (lactic acid and glycogen) compared to oral~     metronidazole in the treatment of BV.~   "
116526|NCT02042274|"~     Fish oil supplements (which are rich in omega-3 fatty acids) have been shown to provide~     cardiometabolic benefits to individuals of all ages. Specifically, the daily consumption of~     fish oil supplements has been reported to reduce blood triglyceride levels, and influence~     glucose homeostasis and whole-body inflammation. However, recent evidence highlights~     important gaps in our understanding with respect to the impact of fish oil supplements on~     health; specifically, not everyone responds to these supplements in the same manner. The goal~     of this research is to explore how an individual's genetic make-up may modify their response~     to fish oil supplements.~   "
116527|NCT02042261|"~     Drug resistant TB is increasing and in order to enchance the efficacy of the current drugs,~     individualized therapy using plasma drug concentrations and minimal inhibitory concentration~     (MIC) determination may be of importance. This concept is defined as therapeutic drug~     monitoring (TDM).~      In this pilot study our hypothesis is that the ratio between MIC and drug concentration data~     is correlated to the bacterial load measured as time to positive liquid culture (TTP).~      In two sites in Sweden (Linköping and Karolinska Hospital Solna, Stockholm), 25 patients with~     pulmonary tuberculosis will be recruited. MIC-determination of Mycobacterium tuberculosis~     will be performed in BACTEC 960 MGIT and drug concentration will be determined at 2, 4 and 12~     weeks after treatment initiation using LC-MS/MS methodology. Sputum cultures will be obtained~     at 0, 2 days, 7 days, 2 weeks, 4 weeks and 8 weeks and TTP will be measured in duplicate~     samples. Clinical follow up according to WHO criteria will be performed 1 year after~     completion of treatment.~   "
116528|NCT02042248|"~     The purpose of this study is to:~        -  find out the intensity and duration of the immune response after multiple injections of~          the investigational study product AGS-004 made from one's own dendritic cells and one's~          own strain of HIV;~        -  understand the changes in the body's HIV DNA , and HIV-1 RNA in peripheral and resting~          CD4+ cells prior to and following administration of AGS- 004.~        -  find out if low levels of HIV virus that are not detectable by standard HIV RNA assays~          will decrease following the administration of AGS-004.~        -  find out if it is safe to give individuals with HIV multiple injections of AGS-004 made~          from the person's own dendritic cells and their own strain of HIV.~        -  find out if administration of AGS-004 decreases the amount of latent HIV infection in~          resting CD4 cells~   "
116573|NCT02041637|"~     The purpose of the study is to evaluate the outcome and to determine predictive factors of~     patients admitted in a context of acute liver failure without identified cause.~   "
116574|NCT02041624|"~     The purpose of the present study is to describe patient's perception of quality of life and~     effectiveness of ORALAIR® over a follow-up period up to 5 years, in real-life settings.~   "
116575|NCT02041611|"~     The primary goal of this study is evaluate T cell immune status and immune reconstitution and~     the association with specific cytokines in patients with newly diagnosed HGGs undergoing the~     standard RT/TMZ and adjuvant TMZ.~   "
117174|NCT02033798|"~     The purpose of this study is to determine whether medical treatment for bladder outlet~     obstruction is effective in improvement of glomerular filtration rate and/or proteinuria.~   "
116529|NCT02042235|"~     In studies of children born at term, language delay at the age of 2 years exhibits a~     spontaneously favourable course in 30 to 50% by the age of 3 years. In France, there is no~     recommendation for speech therapy before the age of 3 years. However, for term-born children,~     parent-implemented language interventions conducted during the third year of life have~     already shown a positive short-term effect on language skills. In these interventions, a~     skilled interventionist, generally a speech therapist, teaches parents how to use specific~     language strategies with their child.~      The investigators' hypothesis is that such parent-implemented interventions would be~     particularly appropriate at short and medium term for the improvement of linguistic~     performances in very preterm children, a population with a high prevalence of early language~     delay. Currently, there is an opportunity to partly nest an intervention trial in a national~     prospective population-based cohort of very preterm children, the EPIPAGE (Etude~     EPIdémiologique sur les Petits Ages GEstationnels) 2 cohort, which has included 5 000 babies~     born alive in France in 2011. This situation provides considerable methodological advantages.~   "
116530|NCT02042222|"~     Sickle cell disease is a disorder in which red blood cells (RBCs) are abnormally shaped. This~     can result in painful episodes, serious infections, chronic anemia (a decrease in the number~     of red blood cells), and damage to body organs. Hydroxyurea therapy offers significant~     benefits for infants, children, and adolescents with sickle cell anemia. These include a~     reduction in the frequency of pain crises and acute chest syndrome (inflammation of the~     lungs) and an increase in hemoglobin (the oxygen-carrying protein) in the blood. Patients on~     hydroxyurea who receive a maximum tolerated dose (MTD) that is specific for them have greater~     clinical benefit than those who receive a standard lower dose. There is, however, no way~     currently to predict the MTD for individual patients. As such, MTD for each patient is~     currently determined by gradual increases in the dose over several months. This process is~     time-consuming, requires monthly clinic visits, and delays the benefits of hydroxyurea~     therapy.~      Our research group has come up with an equation that could be used to predict each patient's~     MTD using baseline clinical and laboratory measures before starting hydroxyurea treatment.~     The purpose of this research study is to compare the use of our equation for predicting MTD~     to the current standard practice of gradually increasing the hydroxyurea dose until MTD is~     reached. We want to see if the use of our predictive equation will allow us to achieve MTD~     faster and with no more side effects than with the standard practice.~   "
116531|NCT02042209|"~     Thoracic pain is the main symptom of acute coronary syndrome (ACS), urgent and serious~     illness. Whereas hospital mortality decreased until reaching 10%, out-of-hospital mortality~     remains high: half of the deaths occur during the first two hours. The benefit of an early~     diagnosis of ACS in term of morbidity and mortality is well established. Identification of~     the coronary origin of a thoracic pain by the telephone triage physician of the pre-hospital~     emergency service (SAMU) leads to the sending of a physician staffed ambulance (UMH) and is~     thus a key element of the prognosis.~      The aim of the study is to build a telephone predictive score of ACS at the triage of calls~     for non traumatic thoracic pain. The separate analysis of the questionnaires by sex will~     authorize the validation of a unique score or two distinct scores for men and women.~   "
116532|NCT02042196|"~     As women get older and go through menopause, levels of the female reproductive hormone~     estradiol decrease to low levels. Also with aging, the functioning of the arteries declines.~     Over time this vascular dysfunction can lead to health problems such as high blood pressure~     and heart disease. This study is being done to help determine what causes arteries to become~     unhealthy in postmenopausal women, who have low levels of the female reproductive hormone~     estradiol. In this study we will test whether low levels of tetrahydrobiopterin (BH4), a~     natural substance in the body that can cause the arteries to expand, explains why arteries~     become unhealthy in women with low levels of estradiol. To answer this question, we will~     study how vascular function changes with a medication that causes a short-term increase in~     BH4 levels when estradiol is lowered with a medication, compared to when estradiol is normal.~     We will also determine whether the administration of the antioxidant vitamin C, along with~     the medication to increase BH4 levels, will normalize vascular health in perimenopausal and~     postmenopausal women, and in women who have their estradiol levels lowered.~   "
116533|NCT02042183|"~     A study of the efficacy and safety of Lubiprostone in pediatric subjects aged ≥ 6 Years to <~     18 years diagnosed with Functional Constipation~   "
116534|NCT02042170|"~     The purpose of this study is to assess dosing requirements and establish the efficacy of~     SR-hGH in idiopathic short stature patients (ISS). This phase II study is designed as~     multi-center, randomized, active comparator-controlled, parallel, open-label.~      45 patients were randomized to three arms with 1:1:1 ratio, two arms of Sr-hGH and one of~     daily hGH. Two doses of Sr-hGH were administered, which are 0.5 and 0.7mg/kg/week. And the~     other arm received daily hGH at 0.37 mg/kg/week.~      Patients in Sr-hGH groups injected on a specific day of the every week for 26 weeks. And~     patients randomized to daily hGH group injected for 6 days a week.~      Patients visited study centers five times, firstly at screening (Visit 1), at randomization~     (Visit 2), after 13th dosing (Visit 3), after 26th dosing (Visit 4), and finally for~     follow-up (Visit5).~   "
116535|NCT02042157|"~     Our expectations (hypotheses) are:~      Primary outcome~        1. Regular bidet use will improve quality of life around elimination in adults with~          impaired functional status. Functional status will be measured by activities of daily~          living (ADL).~        2. Regular bidet use by adults with impaired functional status will improve the quality of~          life around toileting for their caregivers.~           Secondary~        3. Regular bidet use will reduce the incidence, frequency and severity of constipation (as~          measured by self-report) in adults with impaired functional status.~        4. Regular bidet use will reduce the incidence of urinary tract infection (UTI) in adult~          women with impaired functional status.~   "
116576|NCT02041598|"~     The DREAM (Diabetes Research, Education, and Action for Minorities) Project is a Community~     Health Worker (CHW) intervention to improve diabetic management and control among~     Bangladeshis with diabetes in New York City (NYC).~   "
116577|NCT02041585|"~     The DC PROMIS Study (also known as the Discharge Patient Reported Outcomes Measurement~     Information System Study) is a study to see the effect of patients' social, physical and~     mental function on their health after hospital discharge.~   "
116536|NCT02042144|"~     This study is a prospective observational cohort study. The study will be conducted in~     routine clinical practice settings. It is planned to enroll 1000 patients with metastatic~     Colorectal Cancer (mCRC) who have been previously treated with other approved treatments for~     metastatic disease and for whom a decision has been made by the physician to treat with~     regorafenib according to local health authority approved label. It is the aim of this~     observational cohort study to further characterize safety and effectiveness of regorafenib in~     routine clinical practice setting. Healthcare resource utilization in the routine provision~     of care is becoming increasingly important from a health economics and outcomes research~     perspective. Therefore, another aim of this observational cohort study is to capture~     healthcare resource associated with the management of treatment emergent adverse events in~     the real world setting. The primary objective of this study is to further characterize safety~     of regorafenib use in routine clinical practice settings. The secondary objective of this~     study is to assess the effectiveness of regorafenib in routine clinical practice settings as~     measured by Overall Survival (OS), Progression Free Survival (PFS) and Disease control rate~     (DCR). Health Related Quality of Life (HRQoL) Data will be collected in applicable countries.~   "
116537|NCT02042131|"~     The purpose of the proposed study is to identify the most effective brief interventions for~     reducing short-term risk for suicide attempts in real world military triage settings, and~     to identify potential mechanisms of change underlying the interventions' impact on subsequent~     suicide attempts. We will randomize 360 patients to one of three commonly-used crisis~     interventions delivered as routine care in the mental health triage system: (1) Treatment As~     Usual (TAU); (2) Standard Crisis Response Plan (S-CRP); or (3) Enhanced Crisis Response Plan~     with Reasons For Living (E-CRP). The following hypotheses will be tested:~        1. The enhanced crisis response plan (E-CRP) intervention will contribute to significantly~          decreased risk for suicide attempts and hospitalization during follow-up relative to the~          standard crisis response plan alone (S-CRP) and treatment as usual (TAU).~        2. The standard crisis response plan (S-CRP) intervention will contribute to significantly~          decreased risk for suicide attempts and hospitalization during follow-up relative to~          treatment as usual (TAU).~        3. Greater ambivalence about suicide and faster recall of reasons for living will mediate~          the relationship between intervention and reduced risk for suicide attempt during~          follow-up.~   "
116538|NCT02042118|"~     The purpose of this study is to compare the use of a laryngeal mask airway (LMA) vs.~     face-mask ventilation (FMV) during first-line neonatal resuscitation in Mulago Hospital,~     Kampala, Uganda.~   "
116539|NCT02042105|"~     This is a post-marketing, observational, non-interventional, multi-central study of patients~     with non-small cell lung cancer (NSCLC), with data collected prospectively from medical~     records at inclusion. The primary objective is to obtain the epidemiologic data of anaplastic~     lymphoma kinase (ALK)-positive in unselected Chinese patients with NSCLC.~   "
116540|NCT02042092|"~     This study is a cross sectional comparison of the Color Doppler Ultrasonography (CDUS) and~     Magnetic Resonance Angiography (MRA) in patients diagnosed with sLVV. The supraaortic large~     vessels (aorta, carotid, subclavian, vertebral, and axillary arteries) and the temporal~     arteries of fifty patients suffering of sLVV will be examined by CDUS and MRA. The images~     will be evaluated by 2 blinded experts (one for CDUS and one for MRA). In addition, the~     intima media complex (IMC) thickness of the large vessels and temporal arteries will be~     measured by CDUS in 100 sex and age matched controls to the sLVV patients. Blood samples from~     patients and controls will be collected in order to perform genetic and cytokine analyses.~   "
116541|NCT02042079|"~     The purpose of this study is to evaluate the feasibility of endoscopic full-thickness~     resection with laparoscopic assistance.~   "
116542|NCT02042066|"~     Low intensity shockwaves have been proven in animal and human studies to increase tissue~     perfusion, promote angiogenesis and tissue regeneration and improve neural function.~      The hypothesis of this study is that shockwave therapy could improve the symptoms of patients~     with resistant hypertension.~   "
116543|NCT02042053|"~     This study intents to provide an initial evaluation of the utility of positron emission~     tomography and magnetic resonance (PET/MR) imaging measures for the prediction of~     immunological response to Sipuleucel T (SipT) therapy.~   "
116544|NCT02042027|"~     The purpose of the study is to test the investigational drug Gamunex-C on the growth of blood~     vessels over the cornea. This study is being conducted by Dr. Balamurali Ambati at the Moran~     Eye Center at the University of Utah.~      The cornea is the clear outer front part of the eye. In corneal neovascularization, blood~     vessels grow over the cornea. Corneal neovascularization and ocular anterior segment~     inflammations are sight-threatening conditions. Lipid deposition and edema with subsequent~     scar formation can compromise corneal clarity irreversibly. Corneal neovascularization is~     also a well recognized risk factor for corneal graft failure. In its natural state, the~     cornea is a site of immune privilege well suited to tissue transplantation. Once~     vascularized, there is direct exposure of corneal antigens to circulating host immune~     mechanisms greatly increasing the chance of rejection [Collaborative Corneal Transplantation~     Study].~      Melting or inflammation in the anterior chamber, cornea, or ocular surface can cause~     irreversible scarring or destruction of the optical elements of the eye, which can compromise~     vision.~      Current standard of care for such conditions includes use of topical steroids and sometimes~     immunosuppressants (e.g., cyclosporine). These do not address a common underlying corneal~     neovascularization or melting.~      This is a Phase 1 clinical trial of subconjunctival IVIg (Gamunex-C) injection for treatment~     of corneal neovascularization in the setting of corneal transplantation with~     neovascularization. Candidates for corneal transplantation with corneal neovascularization in~     one or more quadrants crossing more than 0.5mm over the limbus will be identified for~     inclusion in our study.~   "
116545|NCT02042014|"~     To provide continued treatment to Pulmonary Arterial Hypertension (PAH) patients who are~     benefitting from treatment with QTI571.~   "
116578|NCT02041572|"~     The study has two goals. First to develop a computer-based intervention meant to alter~     cognitive biases that contribute to ongoing PTSD symptoms. Second, we sought to pilot test~     the intervention in a small sample of veterans for feasibility and acceptability.~   "
119321|NCT02005718|"~     Vitamin D deficiency is common in CKD and assciated with CV complications. Endothelial~     dysfucntion is common in CKD and is a harbinger of atherosclerosis. The study investigated~     the impact of Vitamin D on endothelial fucntion and blood biomarkers in CKD.~   "
116546|NCT02042001|"~     Despite long-term use in clinical practice, chronic treatment with efavirenz (EFV) has been~     associated with persistent central nervous system symptoms or mild or even asymptomatic~     neurocognitive impairment. Whether switching to rilpivirine (RPV) containing regimen is~     beneficial among patients who experience mild or asymptomatic neurocognitive/neuropsychiatric~     adverse events during EFV has not been explored yet.~      The proposed pilot study will examine whether switching from EFV-based regimen to single~     tablet regimen TDF/FTC/RPV is associated with neurocognitive/neuropsychiatric improvement~     among HIV-infected patients with mild/asymptomatic neurocognitive impairment or~     neuropsychiatric symptoms during EFV-containing antiretroviral treatment.~      Patients under stable treatment with EFV, confirmed HIV-1 RNA viral load < 50 copies/mL and~     altered scores in depression, quality of sleep or anxiety tests and/or alteration in 1 or~     more domains as assessed by neuropsychological assessment, will be randomized to immediate or~     deferred (12 weeks) switch to TDF/FTC/RPV. Neurocognitive and neuropsychiatric tests will be~     repeated after 12 and 24 weeks of follow-up and variations will be compared between groups.~   "
116547|NCT02041988|"~     In this study safety and efficacy of oral morphine sulphate is evaluated in order to reduce~     opioids administration during major urological surgery~   "
116548|NCT02041975|"~     To determine the effects of prebiotic 'snacks' on gut health and satisfaction between meals~   "
116549|NCT02041962|"~     This study will determine if a version of the chronic care model for individuals with mood~     disorders seen in small or solo practices can improve patient health.~   "
116550|NCT02041936|"~     The purpose of this study is to evaluate the short and intermediate term outcomes of the~     NanoKnife Irreversible Electroporation System when used to treat unresectable pancreatic~     cancer. In addition, the study will evaluate the efficacy of this device in treating symptoms~     of unresectable pancreatic cancer. The NanoKnife, System has been commercially available~     since 2009, and is FDA-approved to treat soft tissue tumors. The NanoKnife System has~     received FDA clearance for the surgical ablation of soft tissue. It has not received~     clearance for the therapy or treatment of any specific disease or condition.~      Irreversible electroporation (IRE) has the potential to dramatically widen the treatment~     options for patients with pancreatic cancer. It provides a minimally invasive procedure that~     could potentially avoid radical surgery for smaller lesions, and it could potentially offer~     palliation of symptoms such as pain, gastric outlet obstruction and jaundice in patients with~     locally advanced unresectable disease.~   "
116551|NCT02041923|"~     Premature infants are at high risk of suboptimal health and development. This randomized~     clinical trial evaluated the impact of a developmentally based intervention, H-HOPE~     (Hospital-home transition: optimizing prematures' environment), for infants born between~     29-34 weeks gestational age (GA) with at least two social-environmental risk factors. H-HOPE~     will improve infant behavior, mother care for the infants, mother-infant interaction and will~     reduce health care costs.~   "
116552|NCT02041910|"~     Azoospermia is defined as the complete lack of sperm in the ejaculate. In humans, Azoospermia~     affects about 1% of the male population and may be seen in up to 20% of male infertility~     situations. In testicular Azoospermia the testes are abnormal, atrophic, or absent, and sperm~     production severely disturbed to absent. FSH levels tend to be elevated (hypergonadotropic)~     as the feedback loop is interrupted. The condition is seen in 49-93% of men with Azoospermia.~     The purpose of this study is to assess the ability of bone marrow derived stem cells to~     differentiate into germ cells and their role in treatment of testicular Azoospermia~   "
116553|NCT02041897|"~     It is still controversial about the necessity of endoscopy ultrasound guide fine needle~     aspiration (EUS-FNA) on diagnosis of pancreatic cystic lesions(PCL).The aim of this study is~     to find the influence of EUS-FNA on diagnosis and suggestions of EUS specialists.~   "
116554|NCT02041884|"~     The purpose of this study is to further evaluate the treatment for adults with ADHD used in~     our previous study (clinicaltrials.gov ID NCT01659164). It will now be converted to therapist~     supported, internet-delivered cognitive behavioral therapy (iCBT) with an additional~     smartphone application and evaluated through a randomized controlled trial during 12 weeks.~     The patients will be randomized to one of three conditions~        -  an active treatment group where the intervention is based on cognitive - and dialectical~          behavioral therapy (CBT and DBT) and the mobile app.~        -  an active ICBT-treatment based on psychoeducation, a CBT stress-reduction program and~          Applied Relaxation, and~        -  treatment as usual (TAU) / waiting list.~      The main objective of the study is to evaluate if both of the treatment conditions will show~     better outcomes than TAU regarding decreased ADHD symptoms and increased functioning and life~     quality.~      Another objective is to evaluate if the group receiving the active iCBT treatment (based on~     CBT and DBT) will show better outcomes in comparison to the control group regarding ADHD~     symptoms, overall functioning and life quality.~   "
116555|NCT02041871|"~     To study the efficacy of preoperative immunonutrition in reducing postoperative morbidity~     after liver resection for cancer.~   "
116556|NCT02041858|"~     Alarm fatigue, a lack of response to an alarm due to desensitization, is a national problem.~     The problem of alarm desensitization is multifaceted and is related to a high false alarm~     rate, poor positive predictive value, lack of alarm standardization and the large number of~     medical devices with built in alarms in use today. Cardiac monitor alarms are intended to~     notify the healthcare practitioner that a clinical crisis is imminent. However, hundreds of~     physiologic monitor alarms occur on monitored units each day. As a result, practitioners are~     highly vulnerable to alarm fatigue which has resulted in serious harm to patients and death~     due to staff inattention from alarm signal desensitization. Research indicates that 80-99.4%~     of monitor alarms are false or clinically insignificant. Alarm hazards is the number one~     medical device technology hazard of 2012 and has been listed by ECRI (Emergency Care Research~     Institute) among the top 3 medical device hazards for the past three years (ECRI, 2011).~     Delivering actionable alarm information to care providers is challenging given the~     significant number of false alarms.~      Ideally, alarms should activate for events in greatest need of clinical attention without~     increasing the risk of adverse patient outcomes. This is not the case with current monitoring~     technology which is designed for high sensitivity and low specificity. Practitioners must use~     clinical intuition for determining how conservatively alarms should be set to be most useful.~     There is no research evidence to support how best to set alarms without affecting patient~     outcomes.~      Quality improvement studies performed at The Johns Hopkins Hospital have demonstrated that~     the frequency of alarm signals can be reduced by more than 50% through an altered set of~     alarm parameters. This reduction in alarm signals has lead to an increase awareness of alarms~     that do occur as well as create a quieter, healing environment for patients. Although this~     change was not associated with a noticeable increase in adverse patient events, this~     important outcome was not rigorously studied.~      The specific aims of this pilot study is to determine if decreasing the number of alarms by~     using an altered set of alarm parameters has an effect on patient outcomes in an intensive~     care unit.~      This project may have a significant impact on patient safety. A decrease in noise at the~     bedside may result in less distraction to caregivers and may have a positive effect on~     patient recovery. It is expected that the altered set of monitor default parameters will~     result in a decrease in audible alarms without increasing clinically significant adverse~     patient events.~   "
116557|NCT02041845|"~     The majority of patients with limited disease small cell lung cancer (SCLC) experience~     recurrent disease despite receiving concurrent chemoradiotherapy. New agents and~     dose-escalation of chemotherapy have not provided a survival benefit. Local failure accounts~     for high proportion of recurrences. Improved thoracic radiotherapy (TRT) might increase local~     control and thus reduce the recurrence rate and prolong survival. Positron emission~     tomography (PET CT) is better for staging of SCLC than computer tomography (CT) and bone~     scan. More precise localization of tumors leads to more accurate definition of target volumes~     for TRT and reduce the radiation dose to normal tissue. A large proportion of patients~     relapse and die within one and two year after therapy. Few patients survive longer than three~     years. Thus, two-year survival is considered a clinically highly relevant measure of~     efficacy.~      The aim of this study is to compare two schedules of TRT with respect to local control,~     progression free survival, overall survival, toxicity and health-related quality of life. In~     addition patients who have the best outcomes and tolerate chemoradiotherapy will be~     characterized (e.g. clinical characteristics, blood biomarkers, body composition).~   "
116558|NCT02041832|"~     Using implantable loop recorder the investigators wish to detect atrial fibrillation in high~     risk patients and compare it to the results using conventional Holter monitoring. The~     hypothesis is that 10-15% of high risk patients have subclinical atrial fibrillation. The~     investigators want to detect those people so they can receive appropriate anticoagulation~     treatment. The patients will get a comprehensive workup including ecg, echocardiography and~     blood tests.~   "
116559|NCT02041819|"~     Nimotuzumab, a humanized monoclonal antibody against epidermal growth factor receptor~     (EGFR),has been shown to be effective and safe in some studies with head-neck~     cancers.Nab-paclitaxel regimen in advanced NSCLC has a better tumor response rate and safety~     than solvent-based paclitaxel.However,the safety and efficacy of Nimotuzumab plus~     nab-paclitaxel regimen is uncertain in neoadjuvant therapy in esophageal cancer.The~     investigators then initiated a phase II clinical trial with Nimotuzumab plus~     Nab-paclitaxel/cisplatin as the neoadjuvant chemotherapy in patients with locally advanced~     esophageal squamous cell carcinoma to observe the efficacy and safety of the combination.~   "
116560|NCT02041806|"~     The purpose of this study is to determine if Peripheral Nerve Block scoring systems are~     effective in predicting the achievement of intra-operative anaesthesia and post-operative~     analgesia.~   "
116561|NCT02041793|"~     This study is a randomized controlled trial comparing Laparoscopic and endoscopic drainage~     for pseudocyst of the pancreas secondary to acute pancreatitis. The primary outcome measure~     will be resolution of the pseudocyst by the intended treatment within 4 weeks. The secondary~     outcomes will be complications, recurrence and cost analysis between the two methods.~   "
116562|NCT02041780|"~     The purpose of this study is to determine if SWE and Fibrotest®/ Fibromax®, alone or~     associated, are effective methods to assess liver fibrosis in children.~   "
116563|NCT02041767|"~     The purpose of this study is to demonstrate the prostatic diffusion in significant~     concentration of ertapenem achieved after a pre-operative single administration.~   "
116564|NCT02041754|"~     The individual ingredients in IQP-AK-102 have been widely used. Backed by data from several~     studies demonstrating their efficacy, we are conducting this study to look into the efficacy~     and safety of this novel combination of three fibres, in appetite regulation, aiming to~     reduce the appetite.~   "
116565|NCT02041741|"~     This study aims to assess the effects of two different types of interventions aimed at~     increasing happiness in the Flemish general population as compared to individuals that~     receive no intervention.~   "
116566|NCT02041728|"~     The investigators are going to test if it is possible to detect early dementia with the~     digital game memory. The investigators are going to test 15 healthy people and 15 patients~     with early dementia.~      The test consists of playing the game memory several times. While playing, several~     parameters are stored.~      The investigators are going to test if any correlation can be found between these parameters~     and the cognitive state of the person as tested by the Mini-Mental status examination.~   "
116567|NCT02041715|"~     Phase 1, single-center, placebo-controlled, single-blind, first-in-human, single ascending~     dose (SAD) study followed by a multiple-dose cohort in healthy male and female subjects.~   "
116568|NCT02041702|"~     The aim of this study is to assess the safety and efficacy of the SJM MRI conditional pacing~     system in subjects undergoing Cardiac Magnetic Resonance Imaging.The study hypothesis is that~     cardiac MRI scan will not affect the performance of the SJM MRI conditional pacing system~     when special conditions are met. Comparing with the control group,freedom from MRI~     scan-related complications and the electronic performances such as pacing threshold,sensing~     amplitude should be similar.~   "
116569|NCT02041689|"~     Thousands of children are diagnosed with cancer each year, many of whom will achieve long~     term survival due to advances in treatments and technologies. However, when a child is first~     diagnosed, they are confronted with a wealth of new and unfamiliar medical information that~     they must integrate in order to understand their diagnosis and treatment plan. Little is yet~     known about how children with cancer experience learning about their diagnosis and treatment~     in the hospital setting, or the individuals and materials that may help to facilitate the~     child's developing understanding. This information could help to identify or guide~     educational and supportive child life interventions to help children with cancer better~     understand their illness and its treatment.~      This observational study will collect data about how children currently learn about their~     cancer diagnosis and treatment in the hospital setting. The interventions used do not seek to~     change the health outcomes of the participants in this study. The observational data~     collected may serve to improve how future patients learn about their cancer-related~     diagnosis.~   "
116570|NCT02041676|"~     The main objective is to show by a randomised controled therapeutic trial comparing in two~     parallel open arms ( 50 infants x 2 = 100 infants) that the technique IIF decreases the~     duration of non invasive respiratory support in the group treated by chest physiotherapy as~     compared to the control group. The secondary objectives are to evaluate the duration of~     oxygen dependence, the duration of hospitalisation and the proportional advent of~     bronchopulmonary dysplasia.~      These study will be conducted in patients less than 32 weeks post menstrual age, eutrophic,~     treated by non invasive respiratory support after weaning off from mechanical endotracheal~     ventilation benefitting form a social security system and for whom the appropriate parental~     authority are non opposed.~   "
116579|NCT02041559|"~     Robot assisted prostatectomy reduces the patients' postoperative pain and leads to rapid~     rehabilitation. But pneumoperitoneum affects the kidney. The increase of stress hormone~     reduces the glomerular filtration and the vaso-contraction of renal vessels leads the renal~     ischemia. Remifentanil is analgesics coupled with μ opioid receptor. In high dose of~     remifentanil, it is associated with κ and δ receptors, which leads to renal protection effect~     in animal study. Also, remifentanil infusion during anesthesia showed a diuretic effect. The~     purpose of this study is to investigate the remifentanil effect on renal function during~     robot assisted prostatectomy.~   "
116580|NCT02041546|"~     Meconium aspiration syndrome (MAS) is an important cause of severe respiratory failure in~     newborn infants. Treatment for MAS is mainly supportive but surfactant therapy might change~     the course of the disease. Aim of the study to evaluate whether lung lavage with dilute or~     bolus poractant alfa changes the duration of mechanical respiratory support or other outcomes~     in MAS.~   "
116581|NCT02041533|"~     The purpose of this study is to show that Nivolumab will improve progression free survival in~     subjects with strongly Stage IV or Recurrent PD-L1+ non-small cell lung cancer when compared~     to chemotherapy~   "
116582|NCT02041520|"~     Introduction: Highly active antiretroviral therapy (HAART) has showed its effectiveness in~     the prevention of complications in seropositive for HIV patients. However, they develop some~     manifestations such as lipodystrophy, dyslipidemia, and glucose intolerance increasing~     cardiovascular risk.~      Clinical trials in general population and in patients on hemodialysis have demonstrated a~     significant reduction in cardiovascular events using fish oil. Omega-3 fatty acids are~     believed to be beneficial in prevention of atherosclerosis reducing lipids levels specially~     triglycerides. Also in general populations it has been described a benefit effect of omega 3~     acids on oxidative stress.~      Objective: to know the effect of omega 3 acids on different markers of oxidative stress in~     seropositive HIV patients.~      Methods: We will perform a randomized parallel controlled clinical trial in seropositive HIV~     patients from 20 to 55 years old on clinical score A1, A2, B1 or B2 who received HAART. They~     will be randomly assigned to receive omega 3 fatty acids 2.4 g (Zonelabs, Marblehead MA) or~     placebo for 6 months. At baseline anthropometric measurements, lipid profile, glucose and~     stress oxidative levels (nitric oxide, malondialdehyde, total glutathion, and lipid~     peroxidation products) will be evaluated.~      Sample size was calculated according to different variables. We selected the biggest one~     calculated for a difference in nitric oxide of 25% after treatment between groups and a~     standard deviation (SD) value of 10µmol/L. Whit this information we obtained a sample size of~     31 patients per group for an 80% statistical power with α= 0.05. Assuming a 15% patient lost,~     a sample size of 35 per group was considered.~   "
116583|NCT02041507|"~     The degree of protection afforded by colonoscopy against proximal colorectal cancer (CRC)~     appears to be related to the quality of the procedure, and the incomplete removal of lesions~     has been shown to increase the subsequent risk of developing a colon cancer.~      Some studies suggest that small polyps with advanced histology are more common in the right~     than in the left colon (right colon proximal to splenic flexure, left colon distal to the~     splenic flexure). The average size of polyps in the right colon with advanced pathology or~     containing adenocarcinoma was ≤9 mm, whereas in the left colon their average size was >9 mm,~     P<0.001. Inadequate prevention of right-sided CRC incidence and mortality may be due to~     right-sided polyps with advanced histology or that harbor malignancy. These presumptive~     precursors of cancer are smaller and possibly more easily obscured by residual feces, and~     more likely to be missed at colonoscopy.~      Water-aided colonoscopy (WAC) can be subdivided broadly into two major categories: water~     immersion (WI), characterized by suction removal of the infused water predominantly during~     the withdrawal phase of colonoscopy, and water exchange (WE), characterized by suction~     removal of infused water predominantly during the insertion phase of colonoscopy.~      In some reports WE appeared to be superior to both WI and air insufflation colonoscopy (AI)~     in terms of pain reduction and adenoma detection, particularly for <10 mm adenomas in the~     proximal colon.~      In this multicenter, double-blinded randomized controlled trial (RCT) we test the hypothesis~     that that WE, compared to AI and WI, will enhance overall Adenoma Detection Rate (ADR) in CRC~     screening patients. Confirmation of the primary hypothesis will provide evidence that WE~     enhances the quality of screening colonoscopy.~      We also hypothesize that WE may be more effective in detecting proximal colon adenomas than~     WI and AI, particularly <10 mm adenomas, thus increasing proximal colon ADR and proximal~     colon ADR <10 mm. Confirmation of secondary hypotheses will provide justification for further~     testing that WE may provide a strategy to improve prevention of colorectal cancer by~     increasing detection of adenomas in screening colonoscopy.~      Unlike previous reports of single colonoscopist studies, the insertion and withdrawal phases~     of colonoscopy will be done by different investigators. The second investigator will be~     blinded to the method used to insert the instrument, thus eliminating possible bias about~     procedure related issues.~      Several secondary outcomes will also be analysed.~   "
116584|NCT02041494|"~     Hernias are often treated using a prosthetic mesh to add support to the healing wound.~     Prosthetic meshes have been used for decades to repair ventral hernias, level 1 data~     regarding which type of mesh to use is limited. The purpose of this study is to compare the~     effects, good and/or bad, of two types of prosthetic meshes: one that is made from pig skin~     (called a biologic prosthetic), and one that is made in a laboratory (called a synthetic~     prosthetic). This study will include some patients who have an infection in/near the hernia,~     and other patients who do not have an infection. We expect the synthetic mesh to be~     associated with a higher rate of early post-operative surgical site infection and fluid~     collections (seromas), while we expect the biologic mesh to be associated with a higher rate~     of recurrence.~   "
116585|NCT02041481|"~     This phase I trial studies the side effects and best dose of MEK inhibitor MEK162 when given~     together with leucovorin calcium, fluorouracil, and oxaliplatin in treating patients with~     advanced metastatic colorectal cancer. MEK inhibitor MEK162 may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy,~     such as leucovorin calcium, fluorouracil, and oxaliplatin, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving~     MEK inhibitor MEK162 with leucovorin calcium, fluorouracil, and oxaliplatin may kill more~     tumor cells.~   "
116586|NCT02041468|"~     This is a phase IV multicenter trial to evaluate the mechanisms of resistance and~     pharmacoeconomic (PE) impact of crizotinib and its companion diagnostic test used in a~     real-life setting in advanced ALK-positive non-small cell lung cancer (NSCLC) patients.~      The study will address two anticipated issues surrounding personalized medicine and treatment~     with crizotinib:~        -  it will enable real-life Heath Economics and Outcome Research (HEOR)~        -  it will validate and/or identify new blood-based or tissue-based biomarkers of~          resistance to crizotinib.~      At least 30 patients will be recruited in Quebec and Ontario for the PE study. Patients will~     be asked to complete quality-of-life questionnaires at regular intervals in a real-life~     setting of treatment with crizotinib.~      Approximately 25 patients will be recruited to the biomarker sub-study in Quebec to~     understand resistance mechanisms of crizotinib. In these patients, a biopsy from any~     accessible metastatic lesion will be obtained when the patient is no longer responding to~     treatment, as well as blood sampling during regular treatment visits.~   "
116587|NCT02041455|"~     Fibromyalgia is a common condition in clinical medical practice, characterized by diffuse~     musculoskeletal pain. Sleep disorders, chronic fatigue, depression, intestinal disorders and~     headache are also commonly associated with the syndrome .~      Although the etiology of this syndrome is not well defined yet, it means involve multiple~     mechanisms, including low levels of serotonin, increased substance P in cerebrospinal fluid~     and altered circadian variation in sympathetic - parasympathetic balance, consistent with~     changes in sympathetic hyperactivity at night .~      The immune - pineal system, formed by the integration of the adrenergic and immune systems~     pineal gland, appears to be involved in the genesis of the dysfunctions found in~     fibromyalgia. Melatonin is secreted by the pineal gland and has promoter activity of sleep.~     Studies show that melatonin and its precursors , serotonin and tryptophan are reduced in~     patients with fibromyalgia.~      The present study aims to evaluate the relationship of immune - pineal system in the process~     of fibromyalgia , since dysfunction of this axis appears to govern the cascading events that~     participate in the pathophysiological process of this disease.~   "
116588|NCT02041442|"~     The hypothesis is that the intrinsic electrical activity of the urinary bladder in response~     to filling is detectable and can be mapped. This is a pilot study to evaluate the feasibility~     of using cardiac electrical mapping catheters to measure bladder voltage in patients at the~     time of routine urodynamic and cystoscopic evaluation.~   "
116589|NCT02041429|"~     This phase I/II research study is evaluating a combination of drugs called paclitaxel and~     ruxolitinib as a possible treatment for inflammatory breast cancer. Ruxolitinib is a newly~     discovered drug that has been shown to block a pathway (called the IL6/JAK/Stat pathway) that~     may be important in cancer, including breast cancer. Blocking this pathway may stop cancer~     cells from growing. Ruxolitinib has been approved by the FDA for patients with bone marrow~     disease, and this is the first study using this drug in combination with paclitaxel for~     breast cancer. Paclitaxel (also called Taxol) is an FDA drug approved for breast cancer~     patients. Paclitaxel works by blocking the small microtubules inside cancer cells and~     preventing cell growth. Information from laboratory experiments suggests that ruxolitinib~     might also have effects on breast cancer.These studies have shown that ruxolitinib may make~     paclitaxel more effective.~   "
116590|NCT02041416|"~     The goal of this study is to determine the feasibility, reliability, and validity of~     administering the Geriatric Assessment Tool using these two different computer based survey~     platforms, REDCap and Support Screen. The development of a computer based Geriatric~     Assessment Tool has the potential to improve research and clinical practice by providing an~     efficient user friendly means to collect and analyze data for geriatric oncology patients.~   "
116591|NCT02041403|"~     An observational trial aiming to verify whether does any relationship exist between renal~     resistive index and postoperative outcome in major high risk surgery~   "
116592|NCT02041390|"~     Endoscopic implantation of plastic or covered metal stents is widely used in a variety of~     benign pancreaticobiliary diseases, including duct stricture, large or difficult stones, bile~     or pancreatic juice leak, etc. There are some late-stage adverse events after stent~     insertion, such as stent occlusion, proximal or distal migration, secondary duct injury and~     failure of stent removal, etc. The longer the stents were inserted, more likely the adverse~     events would happen.~      Although the optimal time of stent placement has not been well established, it has been~     recommended that plastic stent should be removed/exchanged within 3-4 months and covered~     metal stent be removed within 6 months. However, it was not uncommon that patients with stent~     implantation did not follow the recommendation of further stent management by endoscopists.~      Many methods have been used to improve the adherence of patients in medical service. With the~     advance of mobile technology and popular use of mobile phones, it was believed that the~     patient-centered outcome could be improved by mobile telecommunication with the timely~     support of a patient by a health professional. Thus we hypothesize that mobile technology,~     reminding the patients the necessity of stent management in time by short message service~     (SMS), might increase the patient adherence in patients with benign pancreaticobiliary~     diseases after ERCP.~   "
116593|NCT02041377|"~     The purpose of this study was to determine if subjects who have diabetes can operate the~     Investigational Blood Glucose Monitoring System (BGMS) with no training and obtain valid~     glucose results.~   "
116594|NCT02041364|"~     Fatigue is common in cancer patients receiving adjuvant chemotherapy. To further understand~     the mechanism of fatigue and search for potential biomarkers, we will conduct a prospective~     study with breast cancer patients receiving adjuvant chemotherapy.~   "
116595|NCT02041351|"~     There is clinical benefit of docetaxel administered to patients who have progressed to 3 or~     more lines of chemotherapy including prior exposure to paclitaxel or docetaxel; using~     docetaxel in metastatic stage breast cancer previously exposed to taxanes equal therapeutic~     responses are obtained that it never received taxanes.~   "
116596|NCT02041338|"~     There are no standard neodjuvant regimens adapted according to the different subtypes of~     breast cancer. This is a phase 2, randomized study to evaluate several regimens in different~     subtypes of breast cancer.~   "
116597|NCT02041325|"~     This is a research study to determine if the study drug lenalidomide will increase the body's~     immune response, which is the body's response against infections or tumors, to hepatitis B~     vaccine in patients with plasma cell diseases which include multiple myeloma, monoclonal~     gammopathy of unknown significance (MGUS) and Waldenström's Macroglobulinemia. It is not a~     study to see if lenalidomide is an effective treatment for plasma cell disease.~      Participants in this study have multiple myeloma or other plasma cell disease and have never~     been vaccinated with hepatitis B vaccine. One of the effects of the drug lenalidomide is to~     alter the immune system and thereby increase immune response. It also has some effect against~     cancer cells; therefore, in theory, it may reduce or prevent the growth of cancer cells.~      In this study, one-half of the subjects will be chosen at random to receive the study drug~     and the other half will take a placebo pill (a sugar pill that looks the same as the real~     medication). This is a double blind study where neither the subjects nor the investigators~     know whether the patient receives the study drugs or placebo pills. The effects of the active~     drug lenalidomide will be compared to the effects of the placebo. The results from this study~     will be also be compared with a similar but separate study to be done on individuals without~     known disease.~      This study expects to enroll 64 subjects and will be carried out at the Boston VA Healthcare~     System and the Dana Farber Cancer Institute.~   "
116607|NCT02041195|"~     The purpose of this study is to evaluate the effects of a new daily subcutaneous (SC)~     injectable formulation of RM-493 in healthy obese subjects on mean percent body weight loss~     and other weight loss parameters, as well as Pharmacokinetic (PK) profile. The study is~     designed to evaluate the efficacy and tolerability of RM-493 administered once or twice~     daily. The study drug (RM-493 and placebo) will be administered in a blinded fashion.~   "
116608|NCT02041182|"~     Pediatricians are supposed to talk about youth violence at all heath supervision visits,~     however these types of conversations rarely occur. There have been no studies assessing tools~     to prompt these discussions. The goal of this study is to see if electronic pre-visit~     questionnaires (PVQs) prompt patient-provider discussion of youth violence (YV) in the~     primary care setting. Additionally, patient-provider characteristics are explored as~     mediators to youth violence discussions, as well as feasibility and acceptability of the PVQ~     by patients and providers.~      Adolescents ages 13 to 21 who come to the Hasbro Primary Care Clinics for annual physicals~     will be recruited. A baseline phase was conducted to look at how often providers ask about~     health-related teen behaviors, assessed by exit survey. The experimental period will involve~     adolescents completing health-related behavior PVQ, given to their doctor prior to the visit.~     Exit survey will assess topics discussed. Experimental group will differ from control group~     based on PVQ containing extra questions about youth violence.~   "
116609|NCT02041169|"~     Lower extremity peripheral arterial disease (LEPAD) is a highly prevalent chronic disease.~     Cardiovascular mortality of LEPAD patients at five years ranges between 18 to 30%. LEPAD is~     primarily caused by atherosclerosis that induces an inadequate blood flow to meet the tissues~     demand due to the narrowing of the arteries. An aggravation of the arterial lesions in LEPAD~     patients induces a worsening of patients' symptoms and a severe limitation of their walking~     capacity, contributing to an impairment of their quality of life. Despite maintaining a~     sufficient walking activity is essential for these patients, LEPAD patients lower their~     physical activity, which worsen the disease and potentially contribute to increase the risk~     of cardiovascular events and deaths.~      In a recent study in LEPAD patients, we showed, from a one hour GPS recording, a high~     variability of the patients' walking capacity (i.e., walking distances between two stops~     induced by lower limbs pain). Results suggested that in most patients previous stop duration~     before each walk was a predictor parameter of this walking variability. Whether there is an~     optimal or minimal recovery time influencing the walking capacity in LEPAD patients has never~     been studied.~      This study is a prospective, cross-sectional study in exercise pathophysiology.~      The main goal is to determine, following a walk that induces ischemia, the influence of the~     recovery duration on the subsequent walking performance in LEPAD patients.~      Secondary goals are :~        1. To determine the nature of the relationship between the recovery duration and subsequent~          walking performance.~        2. To study the relationship between exercise ischemia, pain evolution and previous~          recovery duration.~        3. To determine whether the experimental procedure influence the determination of an~          optimal of minimal recovery duration.~        4. To study the influence of recovery duration on walking capacity from community-based~          measurement.~      It is expected to determine for the first time an optimal recovery duration that would~     maximize the walking capacity of LEPAD patients.~      In the medium term :~        -  To give indications to the LEPAD patients to manage their pain in the community without~          lower their physical activity.~        -  To limit the functional decline of LEPAD patients.~        -  To influence the quality of life and cardiovascular mortality. This would deserve~          furthers studies.~   "
116610|NCT02041156|"~     The investigators' purpose is to study which exercise training modality: aerobic physical~     activity in conjunction with either resistance training or balance training, is most~     beneficial in patients with chronic kidney disease (CKD 4-5: GFR < 30 ml/min/1.73mUP[2]).~     Furthermore, our purpose is to evaluate the long-term effects of exercise training on~     functional status, cardiovascular morbidity, blood pressure control, heart rate variability,~     cardiac function, inflammation, body composition, nutritional status, progression of uraemia~     and health related quality of life. This interventional study is prospective, randomized and~     controlled comprising 150 prevalent and incident patients from our outpatient clinic.~     Patients are invited to participate in the study consecutively, irrespective of basic~     functional status. At start patients are randomised either to resistance or balance training~     and the programme is adapted and individualised to each patient's actual physical status and~     ability. The exercise prescription is to exercise for 30 minutes/day, 5 days/week, keeping~     the intensity constant at a level of somewhat strenuous to strenuous on the Borg scale~     rate of perceived exertion. The total observation period is 12 months with checks every four~     months. Although exercise training is a recommended therapy in CKD, there is a lack of~     medical and scientific evidence on optimal prescription. We hope that this study will provide~     evidence-based knowledge on exercise prescription and its effects on various risk factors in~     CKD patients. Finally, if patients achieve a higher degree of physical functional capacity~     they should be able to maintain an autonomous lifestyle, resulting in considerable reductions~     in societal costs for care and transportation.~   "
116611|NCT02041143|"~     This trial is an exploratory study in order to determine whether the ingestion of one type of~     protein (milk protein/CHO/Fat) vs.placebo (CHO/Fat) 2 hours before bed time results in the~     extension of the post-prandial window of anabolism during the night by increasing whole body~     protein balance as well as muscle protein fractional synthesis rate (FSR).~   "
116612|NCT02041130|"~     Investigators will test a new approach to a form of heart failure (HF) with no current~     treatment proven to reduce death rates or hospitalisations. Over a third of HF cases have~     preserved ejection fraction (HFPEF) often on a background of high blood pressure (BP). These~     stiff hearts pump strongly but fill inefficiently resulting in poor exercise capacity and~     high death rates. Treatments that help when heart pumping action is poor are of no benefit in~     HFPEF. Recently a simple catheter procedure removing excess nerve signals to and from the~     kidneys (renal denervation; RDN) has been able to reduce BP in patients with high BP~     resistant to multi-drug treatment. Through removing excess nervous drive to the kidneys,~     heart and circulation this treatment has promise in HF. The investigators will compare~     effects of RDN and standard medical treatment on heart function, exercise capacity and~     quality of life in 144 patients with HFPEF~   "
116613|NCT02041117|"~     1. It is a multicenter, open-label, sing arm study to evaluate the effects of treatment of~          Rosuvastatin 10-20mg in volume and morphology of atherosclerotic plague by reducing~          LDL-C level to or less than 70mg/dl.~        2. Ischemic stroke patients will be enrolled within 1 month after stroke onset.~        3. Patients will be visited at 0m, 1m, 3m, 6m, 9m, 12m, 18m and 24m.~   "
116676|NCT02040298|"~     The main purpose of this study is to assess clemastine as a remyelinating agent in patients~     with relapsing forms of multiple sclerosis. The study will also evaluate the tolerability of~     clemastine, originally approved as first-generation antihistamine, in patients with multiple~     sclerosis. Study procedures will include assessments for evidence of remyelination in the~     anterior visual pathway and in the brain using electrophysiologic techniques and magnetic~     resonance imaging. The study will also assess the robustness and stability of this clinical~     effect in patients taking clemastine for up to 3 months. Patients in this study can remain on~     their standard disease modifying treatment during the course of the study. However, patients~     cannot participate in any other investigational new drug research study concurrently.~   "
116614|NCT02041104|"~     The purpose of this study is to investigate if daily consumption of barley beta-glucans~     effect lipid and glucose metabolism and alter intestinal microbiota composition in~     participants with metabolic syndrome or with high risk for metabolic syndrome development. It~     is assumed that 4-week intervention with beta-glucans will improve some clinical signs of~     metabolic syndrome and alter composition of intestinal microbiota. Variation in microbiota~     composition will be investigated with emphasis on Bacteroidetes and Firmicutes ratio.~     Furthermore it is presupposed that consumption of beta-glucans will stimulate growth of~     beneficial intestinal bacteria from genus Lactobacillus and Bifidobacteria and consequently~     effect production of short chain fatty acids in population with metabolic syndrome. Moreover~     it is presupposed that 4-week consumption of beta-glucans will have influence on glucose~     metabolism and will consequently improve insulin resistance within people with metabolic~     syndrome or high risk for metabolic syndrome development. It is assumed that 4-week~     consumption of beta-glucans will improve specific plasma lipid content in population with~     metabolic syndrome.~   "
116615|NCT02041091|"~     The purpose of this study is to evaluate the amount of tabalumab in the blood after it is~     given by two different injection methods - A traditional syringe or a spring loaded syringe~     for 12 weeks. Participants may continue to receive study drug for up to 52 weeks.~   "
116616|NCT02041078|"~     Intrahepatic division of the hepatic vein is associated with less blood loss than~     extrahepatic dissection and division of the right hepatic vein.~   "
116617|NCT02041065|"~     Before liver transection patients are allocated to either waterjet or CUSA to divide the~     liver parenchyma.~   "
116618|NCT02041052|"~     A small gastric remnant after whipple resection improves gastric emptying and therefore~     prevents the development of delayed gastric emptying.~   "
116619|NCT02041039|"~     Food aromas are a part of foods' flavor, and can promote overeating. Alcohol consumption also~     stimulates appetite, and contributes to overeating while under alcohol's acute effects.~     Knowing the brain regions that respond to food aromas and alcohol, and how they are modified~     by the amount of body fat and alcohol exposure, will provide critical information about the~     neural systems that underlie loss of control of eating. Therefore, the main hypotheses of~     this study are that: A) Lean and obese subjects have different brain responses to food aromas~     that enhance desire to eat, and B) Acute alcohol intoxication i) enhances the brain's~     response to food odors, and ii) affects brain systems that inhibit or terminate eating. To~     test these hypotheses, we have modified functional magnetic resonance imaging (fMRI)~     paradigms successfully used to study alcoholic drink aromas in subjects at risk for~     alcoholism.~   "
116620|NCT02041026|"~     We hypothesis that intake of probiotic yogurt reduces absorption of AFB1 in the gut and~     subsequently reduce AFM1 and aflatoxins adduct, the biomarker in human urine and blood~     respectively. We have demonstrated that yogurt made using weisella cibiria NN20 isolated from~     fermented dough made from pearl millet in eastern part of Kenya sequestered upto 42% of~     aflatoxin available in our invitro texts.~   "
116621|NCT02041013|"~     The research goal is to explore the use and effects of a custom-recordable audio discharge~     instruction card (Talking Card) in the pediatric health care setting. This study will address~     a primary, experimental research question: can pediatric asthma control be improved through~     the distribution of a custom-recorded audio asthma instruction card to parents at the health~     provider's office? Secondary, descriptive objectives will be to evaluate feasibility of~     Talking Card delivery and to collect and summarize parental reactions to the design and use~     of the audio discharge instruction card.~      The specific aims of this study are:~        1. To compare the change in mean Childhood Asthma Control Test (C-ACT) scores for children~          aged 4 through 11 years with uncontrolled asthma receiving a custom-recorded asthma~          instruction card to the change in mean C-ACT scores for those receiving usual care.~        2. To measure the use and impressions of a custom-recordable audio asthma discharge~          instruction card among primary caregivers of children with uncontrolled asthma through~          quantitative and qualitative survey questions.~      The investigators hypothesize that:~      1) Asthma control in children 4 through 11 years of age with uncontrolled asthma, as measured~     by the C-ACT, will improve to a greater extent among those receiving a custom-recordable~     audio discharge instruction card than among those receiving usual care.~   "
116622|NCT02041000|"~     The intent of this clinical study is to answer the questions: 1) Is the proposed treatment~     safe and 2) Is treatment effective in improving the disease pathology of patients with~     diagnosed with chronic obstructive pulmonary disease (COPD).~   "
116623|NCT02040987|"~     A thorough QT study of AZD3293~   "
116624|NCT02040974|"~     Our aim was to evaluate the effectiveness of subcutaneous allergen immunotherapy with the~     symptom scores (RSS), visual analog scale (VAS) and medication scores (MS) and the impact on~     quality of life with rhinoconjunctivitis quality of life questionnaire (RQLQ) in allergic~     rhinitis patients sensitized to different allergens. Also the development of new~     sensitizations and asthma during the immunotherapy were determined.~   "
116625|NCT02040961|"~     The double tube ETView is particularly innovative as it includes an integrated optical fiber~     to visualize the carena. This study aims to verify if if its use avoids the requirement of a~     fibreoptic bronchoscopy.~   "
116626|NCT02040948|"~     The aim of this study is to compare the accuracy of Pleth Variability Index (Radical 7~     device) and of Pulse Pressure Variation (Nexfin device) with the Doppler measurement of~     stroke volume (esophageal Doppler) to detect the response to a fluid challenge.~   "
116627|NCT02040935|"~     This single-arm, open-label, local multicenter study will evaluate the safety and~     tolerability of trastuzumab administered subcutaneously (SC) by a single-use injection device~     (SID) in participants with human epidermal growth factor receptor 2 (HER2)-positive early~     breast cancer (EBC), following surgery and chemotherapy (neo-adjuvant or adjuvant).~   "
116628|NCT02040922|"~     The principal research objective is to determine the impact of antibiotic use on the risk of~     developing long term bowel symptoms after infection with the germ Campylobacter.~   "
116677|NCT02040285|"~     The aim of this study is to evaluate a low-dose of bowel preparation for Computed Tomography~     Colonography (CTC) versus free laxative CTC with regard to performance, feasibility, patient~     tolerability and acceptance.~   "
133888|NCT01814800|"~     This is a Phase III, multicenter, open-label study of RI-002 administered as an intravenous~     infusion of RI-002 (IGIV) every 21 or 28 days in approximately 60 subjects with Primary~     Immunodeficiency Diseases (PIDD).~   "
116629|NCT02040909|"~     Newborns admitted to an intensive care unit often require artificial ventilation. For that~     purpose an endotracheal tube needs to be placed into the trachea, a procedure named~     endotracheal intubation. The newborns need to be sedated to keep them comfortable, to stop~     moving and to relax in order to enable the success of the procedure. For this sedation an~     anesthetic agent named propofol is often used. The used dose of propofol has not been~     properly studied and as a consequence patients are under- or over -sedated and propofol leads~     to side effects such as hypotension.~      The current study aims to find the most appropriate dose of propofol for newborns of~     different gestational ages and of different post-natal ages. We will use propofol in~     different doses and after each 5 included patients per age group we will analyze whether the~     dose needs to be increased or decreased. The effect of the propofol will be extensively~     monitored and we will study the level of sedation, the quality of intubation, the stability~     of the patient en the occurrence of side effects.~      At the end we aim to have appropriate guidelines for propofol doses in newborns of all ages.~   "
116630|NCT02040896|"~     The primary objectives are:~        1. To investigate which healthcare workers and other individuals contribute to the decision~          to order computed tomography (CT) scans for emergency department (ED) patients.~        2. To investigate the specific reasons healthcare workers and other individuals order or~          request CT scans for ED patients.~        3. To determine the frequency of clinically important actions following CT scan results.~      Once the drivers of ED CT utilization are identified, interventions including education,~     incentives for compliance with evidence-based best practices, and interventions for~     noncompliance could be targeted appropriately.~   "
116631|NCT02040883|"~     Efficacy and safety of Tandospirone combined with Atypical Antipsychotic drugs to Improve~     Cognitive function in Schizophrenia~   "
116632|NCT02040870|"~     A single-Arm, open-label, multi-center, phase I/II study in which the pharmacokinetics,~     safety, tolerability and efficacy of LDK378 will be assessed in adult Chinese patients with~     locally advanced or metastatic NSCLC harboring a confirmed ALK rearrangement. Patients must~     have demonstrated progression during or after crizotinib treatment whether or not previously~     treated with cytotoxic chemotherapy. Approximately 100 patients will be enrolled. For the~     first 15 patients enrolled in this study, patients will have an additional 5-day PK run-in~     period before treatment period. The pharmacokinetics profile of LDK378 in Chinese adult~     patients with ALK-rearranged NSCLC will be evaluated.~   "
116633|NCT02040857|"~     This research study is evaluating a drug called Palbociclib in combination with endocrine~     therapy as a possible treatment for hormone receptor positive breast cancer.~        -  Palbociclib is a drug that may stop cancer cells from growing. Palbociclib blocks~          activity of two closely related enzymes (proteins that help chemical reactions in the~          body occur), called Cyclin D Kinases 4 and 6 (CDK 4/6). These proteins are part of a~          pathway, or a sequence of steps which is known to regulate cell growth. Laboratory~          testing has suggested palbociclib may stop the growth of hormone receptor positive~          breast cancer.~        -  Endocrine therapy prevents breast cancer cell growth by blocking estrogen stimulation.~          During this study endocrine therapy will either be tamoxifen or an aromatase inhibitor.~          It is standard of care for premenopausal women to take tamoxifen and for postmenopausal~          women to take either an aromatase inhibitor or tamoxifen after a diagnosis of hormone~          receptor positive breast cancer.~   "
116634|NCT02040844|"~     The purpose of this study is to evaluate the continued effectiveness and safety of Cat-PAD in~     cat allergic subjects for up to five years after the start of administration of treatment.~     The study is an optional follow-up study to a phase III double-blind, placebo controlled,~     Cat-PAD study; no further investigational product is administered.~   "
116635|NCT02040831|"~     Respiratory syncytial virus (RSV) is a common cause of illness in infants and children around~     the world. This study will evaluate the safety and immune response to an RSV vaccine in~     RSV-seronegative infants and children.~      This study is a companion study to IMPAACT 2000.~   "
116636|NCT02040818|"~     Patients who undergo hemodialysis via a tunneled catheter often develop bloodstream~     infections that arise from the catheter. There are several management options for treatment~     of such an infection, though the best option is not clearly delineated. Standard of care~     options include exchanging the catheter for a new one over a guide-wire and instilling a high~     concentration of an antibiotic directly into the catheter lumen. The investigators are~     planning to treat hemodialysis catheter bloodstream infections by one of two strategies: 1.~     Use of a novel antibiotic lock solution Or 2. Changing out the infected catheter for a new~     one. Both these options have comparable cure rates as shown in the medical literature. After~     obtaining informed consent, patients will be randomized to either treatment arm and will~     continue to receive all other standard medical care.~      Specific Aim: To conduct a randomized clinical trial to demonstrate that the use of a novel~     antibiotic lock solution (consisting of N-acetylcysteine, tigecycline and heparin) is~     non-inferior to guide-wire exchange in the treatment of hemodialysis catheter-related~     bacteremia.~   "
116637|NCT02040805|"~     This study proposes to compare two forms of treatment for Hoarding Disorder (HD), a common~     and impairing neuropsychiatric syndrome that has a profound impact on the lives and~     functioning of individuals, families, and society. Specifically, we will compare a novel~     community-based group treatment led by individuals from the community who are not mental~     health professionals to the current standard of care treatment for Hoarding Disorder,~     cognitive behavioral therapy, conducted by psychologists in a group setting. We hypothesized~     that both treatment types will be similarly effective in reducing hoarding severity.~   "
116638|NCT02040792|"~     This study evaluated the safety and efficacy of four doses of TD-4208 and a placebo product~     when administered once daily for 28 days using a jet nebulizer to patients with moderate to~     severe chronic obstructive pulmonary disease.~   "
116639|NCT02040779|"~     This is a randomized, double-blind, placebo-controlled parallel-group study. Participants~     will be randomly assigned to receive treatment with beclomethasone dipropionate at a dosage~     of 80 or 160 mcg/day delivered via a Breath-Actuated Inhaler (BAI); or a matching BAI~     placebo, in a 1:1:1 ratio after a 14- to 21-day run-in period. Participants and investigators~     will remain blinded to randomized treatment assignment during the study~   "
126726|NCT01908725|"~     The overall objective of this trial is to provide aftercare treatment with Lamazym and to~     evaluate the safety of repeated Lamazym i.v. treatment of subjects with alpha-Mannosidosis~     whom previously participated in Lamazym-trial.~   "
116641|NCT02040753|"~     In Denmark and the western world, there is an increasing prevalence of obesity probably due~     to a combination of inadequate daily physical activity and a high energy intake. One approach~     to achieve weight loss and change life style is to participate in an intensive supervised~     prolonged life style modification course. The immediate effect is often positive, but over~     time the overall effect is limited as the majority will not maintain weight loss and a~     changed life style.~      In this study we will analyse the results of the intensive lifestyle intervention as it has~     been practised at Ubberup Folk High School over the last 13 years. As some people have~     several stays at Ubberup Folk High School we want to we have a special interest in the effect~     of repeated lifestyle intervention.~      Research question:~      What is the effect of several lifestyle interventions on weight loss maintenance?~      The study design is retrospective and descriptive and will be based on a lifestyle~     intervention, as it has practiced in a real life setting at Ubberup folk high school.~   "
116642|NCT02040740|"~     An identified hormone linking bone and kidney function is Fibroblast Growth Factor-23~     (FGF23). Data on the variation of FGF23 levels for bone and mineral metabolism in children~     are scarce. Currently it is assumed that meeting mineral requirements for the skeleton serves~     the body's overall needs. However, it is not clear as to whether this is true, particularly~     with growth. The contribution of dietary factors directly linked with the bone/kidney axis~     through measurement of intake (via 24hr recall) and kidney nutrient clearance (via serum and~     urinary analysis) will be included in investigations. Findings will serve as a springboard~     for delineating more specific mechanisms by which these systems become disordered and are~     influenced by diet. It is expected that adequacy of nutrients known to have a central role in~     bone function will optimize the hormonal milieu through crosstalk with the kidney.~      This effort will allow ongoing investigation in detecting and treating disturbances in~     mineral metabolism related to kidney disease, specifically in the pediatric population and~     broaden the understanding of kidney disease itself, as well as that of chronic diseases in~     which kidney health is of importance, such as diabetes and osteoporosis. Findings of this~     research may stress the importance of achieving dietary adequacy essential for establishing~     optimal body composition trajectories, particularly puberty.~   "
116643|NCT02040727|"~     This project will evaluate the impact of resistance training on the synthesis and release of~     hormones and growth factors from the musculoskeletal system and the extent to which the~     communicative capacity influences glucose homeostasis In turn, the contribution of glucose~     regulation on the musculoskeletal system will also be evaluated. This small study will serve~     as a pilot/feasibility study to define a protocol for implementation of a resistance training~     intervention in the pediatric population. To establish feasibility, this study population is~     limited to overweight African American boys ages 7-11 years.~      In light of well-established accolades of resistance training, historical recommendations for~     avoidance among the pediatric population have deterred implementation of resistance training~     interventions in young adolescents. However, contemporary data indicating a profound benefit~     of resistance training to the skeletal system in pre-adolescents has led to the Academy of~     Sports Medicine, as well as various other pediatric health interest groups, to support~     supervised programs incorporating resistance training in young children, emphasizing large~     muscle and core strengthening. To date, such trials have not been conducted in the pediatric~     population~   "
116644|NCT02040714|"~     Legg-Calvé-Perthes disease is a childhood hip disorder which is common enough to be a~     significant public health problem (affects 1 in 740 boys between ages 0—14), but uncommon~     enough to have a sufficient number of patients from a single institution to perform a~     definitive prospective study comparing the results of current treatments. The present study~     will establish a database of prospectively identified patients with Legg-Calvé-Perthes (LCP)~     Disease and collect information regarding their presentation, treatment, and outcomes in the~     course of receiving currently available treatments.~      This study seeks to compare the outcomes of current treatments in the management of different~     age groups (ages 1-6, 6—8, 8—11, >11) of patients with Perthes disease at two- and five-year~     followup and at skeletal maturity. For each age group, two to three common treatment regimens~     currently used by practicing pediatric orthopaedic surgeons will be compared. The~     intervention a patient receives is determined through physician preference. Physicians pick~     an intervention for each age group and treat each patient with the same intervention.~   "
116645|NCT02040701|"~     The purpose of the study is to measure markers of inflammatory and oxidative stress known to~     be associated with cardiovascular morbidity in snoring children.~      In addition, to measure markers of local inflammation and to evaluate the response to~     treatment.~   "
116646|NCT02040688|"~     Behavioral insomnia of childhood is a prevalent condition, affecting 10-30% of children 6-36~     months of age. If left untreated, bedtime problems and night wakings can negatively impact~     the daytime functioning and behavior of the child, as well as the entire family.~      Feeding difficulties are common in pediatric practice and encompass a spectrum ranging from~     children with physiological difficulties in ingesting food, through picky eaters to full~     fledged infantile feeding disorders.~      We have recently shown that feeding and eating difficulties are more prevalent among children~     with behavioral insomnia of childhood and that sleep problems are more frequent in children~     with feeding disorders.~      We hypotesize that SPD is a common etiology for both sleep and feeding disorders and that~     children with sleep or feeding disorder have increased rate of Sensory intergration disorder~     (SID) compared with healthy controls.~   "
116647|NCT02040675|"~     The purpose of this study is to validate a novel method of diagnosing arrhythmias using the~     NAVA catheter-positioning screen in patients who have a NAVA catheter in place.~   "
116648|NCT02040662|"~     Thoracic surgery correlates with significant pain in postoperative period. In order to~     alleviate the pain various combinations of pharmaceuticals and administration methods are~     employed. So as to reduce the extent of surgical trauma and, consequently, correlated pain~     various operation techniques are used. In traditional thoracotomy epidural anesthesia remains~     a golden standard. Epidural anesthesia however demands high skills to be performed correctly~     and presents an increased risk of grave complications. In videothoracoscopic (VATS)~     operations paravertebral blockade can be employed, yet there is no certainty if its efficacy~     after lung lobectomy. We therefore designed a prospective, randomized, parallel group, single~     site study to test the hypothesis, that continuous paravertebral blockade is as efficient in~     postoperative pain reduction as continuous epidural blockade and possesses a higher safety~     profile.~   "
116649|NCT02040649|"~     Through many years, the standard care has been to use continuous sedation of critically ill~     patients during mechanical ventilation. However, preliminary randomised clinical trials~     indicate that it is beneficial to reduce the sedation level in these patients. The NONSEDA~     trial is an investigator-initiated, randomised, clinical, parallel-group, multinational,~     superiority trial designed to include 700 patients from at least six ICUs in Denmark, Norway~     and Sweden, comparing no sedation with sedation and a daily wake-up trial during mechanical~     ventilation. This is a substudy of the NONSEDA trial, concerning 250 patients included at~     trialsite Kolding, Denmark. The aim of the substudy is to assess the effects of no sedation~     on posttraumatic stress disorder after discharge from ICU.~      Our hypothesis is that critically ill patients who are not sedated during mechanical~     ventilation will have less posttraumatic stress disorder after discharge.~   "
116650|NCT02040636|"~     Primary objective:~        -  To determine the safety and immunogenicity of tetanus and diphtheria toxoids adsorbed~          combined with component pertussis and inactivated poliomyelitis vaccine grown on vero~          cells (TdcP-IPV) compared to tetanus and diphtheria toxoids adsorbed combined with~          component pertussis and inactivated poliomyelitis vaccine grown on vero cells (TdcP-IPV)~          and Hepatitis B vaccine administered concurrently in adolescents 11-14 years of age.~      Secondary objective:~        -  To determine whether concurrent administration of TdcP-IPV and Hepatitis B vaccines at~          11-14 years of age results in detectable immunologic interactions between components of~          the two vaccines.~   "
116651|NCT02040623|"~     -  To assess the efficacy of R348 Ophthalmic Solutions administered for 12 weeks to~          subjects evaluated by objective and subjective measures.~        -  To investigate the safety and tolerability of R348 Ophthalmic Solutions administered for~          12 weeks to subjects.~   "
116652|NCT02040610|"~     This study is being proposed to evaluate the use of moderate hypofractionated proton therapy~     in low and intermediate risk prostate cancer patients. Quality of life outcomes as well as~     gastrointestinal and genitourinary early and late toxicities will be analyzed and compared to~     conventional proton therapy regimens. It is thought that this regimen will produce comparable~     findings and would result in substantial health care cost savings, as well as, be more~     convenient for patients.~   "
116653|NCT02040597|"~     The study is performed to characterize the pharmacokinetics of glycopyrrolate bromide after~     single administration of CHF 5993 pressurised Metered Dose Inhaler (pMDI) in subjects with~     different level of renal impairment in comparison with matching healthy volunteers. Moreover,~     the safety and tolerability of the study drug will be also evaluated.~   "
116654|NCT02040584|"~     Assuming greater efficacy in the prevention of acute rejection in the EVR arm with~     minimisation of TAC levels, the hypothesis of the present trial is that the introduction of~     EVR in combination with the minimisation of TAC (rTAC) may offer improved kidney function~     compared with standard therapy with TAC-MMF.~   "
116655|NCT02040571|"~     The overall aim of the study is to evaluate the performance of Artificial Pancreas or Closed~     Loop Glucose-Sensing Insulin-Delivery system in comparison to current best available~     technology represented by Sensor Augmented Pump Therapy (SAPT) in patients with Type 1~     Diabetes.~   "
116656|NCT02040558|"~     This is a multicenter, open-label, dose escalation study of MNK-010 in subjects with advanced~     solid malignancies who have failed conventional therapy. The safety, tolerability,~     pharmacokinetic (PK) profile, and preliminary antitumor activity of ascending doses of~     MNK-010 will be evaluated in subjects with advanced solid tumors.~   "
116657|NCT02040545|"~     This study aims to determine the performance of a salivary hormone competitive immunoassay~     for monitoring patients during treatment for infertility.~   "
116658|NCT02040532|"~     The broad goal of this study is to obtain pilot data to determine the tolerability and~     preliminary efficacy of the non-hormonal agent gabapentin for insomnia symptoms and nighttime~     vasomotor Symptoms (VMS) when open-label gabapentin is administered at low dose and only at~     night in peri- and postmenopausal women. We hypothesize that the majority of participants~     will be able to increase and tolerate treatment, and insomnia symptoms and the frequency of~     nighttime VMS will improve on low-dose gabapentin dosed at bedtime.~   "
116659|NCT02040519|"~     Sacral neuromodulation (SNM) is a minimally invasive secondary treatment for overactive~     bladder syndrome (OAB) or for non-obstructive urinary retention (NOR), when refractory to~     conservative treatment. Success rates range from 70 to 80%, and good long-term results are~     reported. The working mechanism of SNM is not completely understood, and the only prognostic~     factor for good response to this treatment is a successful test stimulation period. There is~     no consensus on the duration of this test stimulation period. The experience in our clinic~     during test stimulation period is that for responders it takes up to one week to achieve~     maximal effect, after the system is turned 'on'. On the other hand the investigators notice~     that after turning the neuromodulation system 'off', it will take a few hours for symptoms to~     return to the baseline situation. The fact is: no information concerning the so called time~     of onset and time of offset (or popular called: wash-in / wash-out) of sacral~     neuromodulation is available in current literature.~   "
116660|NCT02040506|"~     This study will examine the safety and tolerability of IGN523 administered as an IV infusion.~     The main purpose of the study is to determine the maximum tolerated dose (MTD), which is the~     highest dose that does not cause unacceptable side effects of IGN523 in patients with acute~     myeloid leukemia (AML). The MTD will be determined by observing the dose-limiting toxicities~     (the side effects that prevent further increases in dose) of IGN523. In addition, the~     pharmacokinetic profile and anti-leukemia activity of IGN523 will be assessed. A recommended~     Phase 2 dose (RP2D) of IGN523 will be identified, on the basis of safety, pharmacokinetic~     (PK), and pharmacodynamic (PD) data.~   "
116661|NCT02040493|"~     This is a physician sponsored multi-center, non-randomized, prospectively enrolling data~     collection study of patients with early stage breast cancer treated with electronic~     brachytherapy at the time of surgical resection of the cancer in the operating room. The~     radiation therapy treatments will be administered with electronic brachytherapy using the FDA~     cleared Xoft Axxent System.~   "
116662|NCT02040480|"~     This study is being conducted to measure the relative bioavailability of the original gelatin~     capsule formulation and a new formulation, immediate release (IR) tablet of Afuresertib~     (GSK2110183). The study will be composed of Screening, Treatment, and Follow-up Periods. A~     subject's total time involved in the study will be approximately 9 weeks. The study will~     enroll approximately 18 healthy volunteers.~   "
116664|NCT02040454|"~     The objective of this study is to evaluate the safety and effectiveness of the use of~     intravascular paclitaxel, in addition to standard therapy, for the treatment of arteriovenous~     dialysis access fistula stenosis.~      A fistulogram will be performed in standard fashion. The diagnostic component will include~     evaluation of the inflow artery, arterial anastomosis and full length of the fistula vein or~     graft, plus venous return up to the heart. The location, vessel size, lesion diameter and~     percent stenosis for each lesion will be recorded. Enrollment and randomization will occur at~     this point.~      All patients will then receive standard therapy for their stenosis. This will include~     intravenous heparin administered in a standard dose of 70 units/kg. Lesions that respond~     poorly to angioplasty (>30% residual stenosis after angioplasty treatment with 2 inflations)~     will be stented. Stent selection will be based on clinical setting. Initial stent treatment~     will utilize an uncovered nitinol stent. Treatment of in-stent restenosis will include~     initial balloon angioplasty, and use of a covered stent (Viabahn, GORE, or Fluency, Bard).~     Documentation of location and type of treatment for each lesion treated will be recorded.~      Once standard treatment is completed, the operating surgeon will be informed of the results~     of randomization: treatment (paclitaxel) or control. For subjects assigned to treatment, the~     whole fistula vein outflow segment of the fistula will be treated with paclitaxel.~      The full length of the radial artery from 1 cm of its origin to fistula anatomosis will be~     treated with paclitaxel. In addition the anastomosis and first 4 cm of the fistula vein will~     be treated. Paclitaxel solution treatment of each lesion encountered will be attempted until~     the 20 mg Paclitaxel dose limit is met. The volume administered will depend on the diameter~     and length of the vessels treated. Maximization of the length of vessel and lesions treated~     will be undertaken when there are more lesions than can be accommodated by the 12 mg, 10 ml~     dose available.~      A 5 F sheath, 20 cm in length, will be used to administer the paclitaxel. This will be~     advanced from its distal position in the radial artery over the guidewire so that the tip of~     the sheath is in the proximal radial artery.~      Prior to removal of the sheath, a final angiographic study of all areas treated is performed~     to document patency and lesion appearance. Any additional lesions identified with this study~     are then treated appropriately following standard technique.~      For the control group, instead of paclitaxel administration, a sham treatment period of 10~     minutes is allowed to elapse followed by the performance of the final completion angiogram.~     Any additional lesions identified with this study are then treated appropriately following~     standard technique.~      All patients will follow the same follow up evaluation schedule~   "
116665|NCT02040441|"~     This is a prospective, multicenter, randomized, double blind, placebo-controlled and a~     prospective observational study.~      This study will be conducted at 15 study centers in various European countries. 1777~     participant between 18 to 75 years old with Type 2 diabetes mellitus and normoalbuminuria~     participate in the study. The study period is 2 - 4.5 years (excluding the 6 week screening~     period). Depending on the risk score of the urinary protein pattern, participants have been~     stratified into an observational group or an interventional group. Participants with the low~     risk pattern (observational group) attend visits annually after screening and baseline.~     Participants with the high risk pattern (interventional group) attend study visits every 13~     weeks after screening and baseline.~      The interventional group has been allocated into one treatment group either receiving~     spironolactone or placebo. A placebo is a medicine without a pharmaceutical substance. The~     allocation to one of the two treatment groups has been done by a random distribution~     procedure established before the study start.~      The results of the urine sample from the Screening visit has been analysed and the urine~     proteomic pattern is determined to be either low- or high risk pattern and will determine the~     further study program.~      Participants with a low-risk pattern (observational group):~      During the study period, participants attend an annual project visit, were regular diabetes~     care is performed and three urine samples are analysed for albuminuria.~      Participants with a high-risk pattern (intervention group):~      Participants with a high-risk pattern have been randomized to either spironolactone treatment~     or placebo. The treatment is one tablet for oral use to be taken once a day for the entire~     study period. Four times each year (every 13th week) a study visit is conducted including~     examination of three urine samples for albuminuria.~      This study aims to:~        1. Confirm in a prospective multicenter study of normoalbuminuric type 2 DM patients that~          the urinary proteome test identifies patients with a high risk for development of~          microalbuminuria.~        2. Demonstrate the clinical utility of the test by showing that aldosterone blockade in~          high-risk patients can reduce progression to microalbuminuria in comparison to placebo,~          on the top of standard treatment in a randomized double-blind, placebo-controlled~          multicenter study.~   "
116666|NCT02040428|"~     The objective of this study is to evaluate the safety and effectiveness of the EVARREST™~     Fibrin Sealant Patch as an adjunct to hemostasis during cardiovascular surgery.~   "
116667|NCT02040415|"~     The purpose of this clinical study is to determine whether or not DW-1030 is not inferior to~     eperisone HCl in efficacy and safety.~   "
116668|NCT02040402|"~     Pneumonia is one of the most prevalent diseases in infants and children. The incidence of~     pneumonia in children less than 5 years old is about 34-40 cases per 1000 in Europe and~     America and more than 2 million children die of pneumonia annually. It was reported that~     Streptococcus pneumoniae accounted for 13%-53% of lower respiratory tract infections in~     different age group of infants or children. In addition, 7%-9% of bacterial meningitis was~     due to Streptococcus pneumoniae infection. In addition, children infected with Streptococcus~     pneumoniae often transmit the pathogens to adult. As a result, it is evident that~     Streptococcus pneumoniae presents a heavy burden to paediatrics practice.~      Vaccination of 7-valent pneumococcal conjugate vaccines is effective in preventing~     Streptococcus pneumonia .Routine use of PCV7 in the US has rapidly reduced rates of invasive~     pneumococcal disease in children. The impact of the vaccine was noted within 1 year of~     introduction. According to Centre for Disease Control's (CDC) Active Bacterial Core~     Surveillance (ABCs) the incidence of invasive pneumococcal disease among children <5 years~     dropped 75% from 1998/1999 to 2005; disease caused by vaccine-type strains fell 94% from 80~     to 4.6 per 100,000. Currently there are two immunization schedules: manufacturer recommended~     the 3+1 schedule and many countries adopted a 3 dose schedule, either 3+0 or 2+1 schedules.~     In US, it is recommended to give three doses during infancy (scheduled at 2, 4, 6 month) plus~     one dose at 12-15 months (3+1 schedule). Since several studies have demonstrated that two~     doses may provide similar direct protection to three conjugate doses during infancy, it is~     recommended to give two doses during infancy plus a booster dose 12 months in some European~     countries including United Kingdom.~      In this trial, the immunogenicity of the 3+1 schedule and the 2+1 schedule of 7-valent~     pneumococcal conjugated vaccine in young infants will be compared.~   "
116669|NCT02040389|"~     The aim of this study is checking impact of visual guidelines (picture book) and tutoring in~     pediatric urologic surgery~   "
116670|NCT02040376|"~     A placebo controlled double blind crossover trial of metformin in 30 children treated with~     radiation for medulloblastoma - the most common malignant brain tumour. The investigators~     will use tests of thinking and learning and brain imaging techniques to examine whether~     metformin can enhance cognition or promote brain repair following radiation-induced brain~     injury.~   "
116671|NCT02040363|"~     COPD patients experiment a peripheral muscle dysfunction which impact their exercise~     tolerance and health-related quality of life. The capillary to fiber interface is reduced and~     impact the exercise capacity of the patients. While exercise training induce a physiological~     angiogenesis, we have recently observed that there was a blunted muscle angiogenesis after~     training in COPD patients. This could be the consequence a an inadequate training duration or~     intensity. Aim of the study: Compare the muscle micro-vascular response to training~     (capillary-to-fiber ratio) at 5 and 10 weeks, in sedentary healthy subject trained at the~     intensity of the ventilatory threshold (60-65% of VO2max), versus :- COPD patients trained at~     a similar intensity (60-65% of VO2max)- COPD patients trained at a similar absolute intensity~     (90% of VO2max).~   "
116672|NCT02040350|"~     To evaluate the effectiveness of Pralidoxime, a drug used for treatment of pesticide~     poisoning (Organophosphorous poisonings)~   "
116673|NCT02040337|"~     The purpose of this study is to investigate CD8 + T-cell receptor (TCR) repertoire~     differences between patients with type 1 diabetes mellitus and type 2 diabetes or healthy~     controls.~   "
116674|NCT02040324|"~     We measure in this study lung function of 100 patients immediately after major lower~     abdominal surgery. We compare lung function, when either endotracheal intubation, or~     laryngeal masks are used for airway protection during surgery. The hypothesis is that the use~     of laryngeal masks is associated with less impairment of lung function in the immediate~     postoperative phase.~   "
116675|NCT02040311|"~     The purpose of this study is to determine the efficacy and safety of topiramate (96 mg or 192~     mg daily) as compared to placebo in maintaining weight loss in obese subjects who~     participated in an eight week intensive non-pharmacologic weight loss program.~      The primary efficacy endpoint will be the percent change in body weight from enrollment visit~     to week 60.~   "
116678|NCT02040272|"~     Mesothelioma is a cancer of the thin membrane that lines the chest and abdomen. Around 2300~     people in the UK are diagnosed with mesothelioma each year and the average survival is~     approximately 17 months. Exposure to asbestos is the most common cause although the cancer~     does not usually become apparent until 30-40 years after exposure. Anti-cancer drugs~     (chemotherapy) are usually given to help treat mesothelioma and sometimes lung-sparing~     surgery (pleurectomy decortication) surgery is undertaken. However, it is not known if this~     surgery, in addition to chemotherapy, can increase survival and improve the quality of life~     for patients. The aim of the MARS2 study is to determine if it is feasible to enrol patients~     with mesothelioma into a study randomising them to chemotherapy only or chemotherapy and~     lung-sparing surgery. Patients will be followed up regularly at their usual clinic visits for~     to 5 years. Patients will be asked to complete a Quality of Life Questionnaire at these~     visits. Tissue samples will be taken at the time of diagnosis and at surgery (if they are~     randomised to surgery) for mesothelioma research central storage and blood samples will be~     taken at the clinic visits up to 12 months for mesothelioma research central storage. If we~     can show the feasibility of recruitment we will apply to continue the study to include more~     patients in order to determine if lung-sparing surgery improves survival and quality of life~     for mesothelioma patients.~   "
116679|NCT02040259|"~     The purpose of the Trevo® Retriever Registry is to collect real world performance data of the~     Trevo Retriever which is intended to restore blood flow in the neurovasculature by removing~     thrombus in patients experiencing ischemic stroke.~   "
116680|NCT02040246|"~     The prevalence of diabetes is up to 11.6% according to the data released in 2013 by the China~     Noncommunicable Disease Surveillance Group.Less than 40% of all diagnosed-diabetes were well~     controlled.Among all kinds of antidiabetic medications, metformin is recommended as the~     first-line antihyperglycemic management for type 2 diabetes. Insulin secretagogue,repaglinide~     is still one of the most widely used antidiabetic medications in China. However, there were~     few studies comparing the effects of these two medications on glycaemic control in Chinese~     patients with type 2 diabetes.~   "
116681|NCT02040233|"~     This is a study to investigate the safety, tolerability and early effects on cardiac function~     of the partial A1 agonist BAY1067197 in patients with chronic heart failure. BAY1067197 will~     be applied once daily over 7 days in addition to standard therapy including a beta-blocker.~     The aim of the study is to assess if a 7 day treatment with BAY1067197 is well tolerated when~     given on top of standard therapy for heart failure. Furthermore, the study aims to assess if~     cardiac function improves in the early course of therapy.~   "
116682|NCT02040220|"~     This is a prospective, non-interventional, multi center post-authorization safety study that~     includes patients with a diagnosis of CRVO. The investigator will have made the choice of~     treatment (EYLEA) as well as the decision to use EYLEA according the Japanese Package Insert~     prior to enrolling the patient in this study.~      The observation period for each patient starts when therapy with EYLEA is initiated. The~     enrollment period is 2 years. Patients will be followed for a time period of 2 years or until~     it is no longer possible (e.g. lost to follow-up) within the 2 years.~      For each patient, data are collected as defined in the case report form at the initial visit,~     follow-up visits and final visit, either by routine clinical visits (as per investigators~     routine practice).~      There will interim analysis of study data: 6 months after last patient first visit and~     J-PSUR(Japanese-Periodic Safety Update Report )~   "
116683|NCT02040207|"~     The purpose of this research study is to test the safety and local tolerance of repeated~     treatment with AM-101.~   "
116684|NCT02040194|"~     The purpose of this research study is to test the safety and effectiveness of the study drug,~     AM-101. AM-101 is tested for the treatment of tinnitus that started as the result of an~     injury to the inner ear or due to middle ear inflammation (otitis media). Subjects with~     tinnitus can take part in the study, if their tinnitus started within the last 3 months or~     within the last >3 to 6 months.~   "
116685|NCT02040181|"~     It's important to dose according to renal function in who has impaired kidney function. There~     are two common methods estimating renal function: one is creatinine clearance estimated by~     Cockcroft-Gault (CG) equation; another is glomerular filtration rate estimated by~     Modification of Diet in Renal Disease (MDRD) equation.~      The previous study (not published) showed that CG underestimated 24 hour measured urine~     creatinine clearance by our team. The difference may be due to ethnicity. Thus we want to~     establish a estimated creatinine clearance equation fitting in Taiwanese.~      Besides, there are lots of studies discussing difference between CG and MDRD. We have found~     that MDRD overestimated CG in patients who were older or thin. Therefore, we want to analysis~     which characteristics of patients the difference are largest or smallest.~   "
116686|NCT02040168|"~     Mechanical ventilation is a common procedure used in pediatric intensive care units (ICU).~     Its use requires almost always the establishment of a sedation. Sedation is a generic term~     for all procedures, pharmacological or not, ensuring physical and psychological comfort and~     the safety of patient admitted in intensive care units.~      An inadequate sedation, insufficient or excessive, has common side effects, as increase of~     the duration of mechanical ventilation and of hospital-acquired infections (in particular,~     ventilator associated pneumonia), of hemodynamic disorders, of extubation failure or~     accidental extubation, of withdrawal syndrome, and of post-traumatic stress disorder (PTSD).~     All these complications increase mechanical ventilation time and ICU length of stay. Several~     studies in adult's population have shown that the implementation of a sedation algorithm~     allowed to decrease the incidence of these complications.~      We hypothetized that the duration of mechanical ventilation would be reduced by a~     nurse-implemented sedative management protocol.~   "
116687|NCT02040155|"~     This is an observational study. The purpose is to determine the feasibility of using a novel~     nano-scintillator fiber-optic dosimeter (nanoFOD) for the real time dosimetric monitoring of~     brachytherapy treatment. Women with gynecologic cancers treated with brachytherapy as part of~     their standard therapeutic regimen will represent the study population.~   "
116696|NCT02040038|"~     The purpose of this study is to determine whether participation in virtual environment which~     incorporates real-time diabetes self management and support (DSMT/S) is associated with~     positive changes in behavior and metabolic outcomes as compared to traditional web-based~     DSMT/S.~   "
116688|NCT02040142|"~     This is a clinical study investigating the new treatment of surgery combined with~     intraperitoneal mitomycin-C for patients with gastrointestinal cancer that has spread to the~     peritoneal (abdominal cavity) surface. Mitomycin-C to be used in this procedure is approved~     by the U.S. Food and Drug Administration (FDA)for many different cancers including~     gastrointestinal cancer. Giving mitomycin C via the intraperitoneal route is not FDA approved~     and is an investigation therapy. Cytoreductive surgery plus intraperitoneal chemotherapy can~     be offered as standard of care outside of a clinical trial. However, since this is an~     unproven and potentially more effective but a more toxic approach, the investigators are~     performing this procedure under an IRB approved clinical trial in order to better evaluate~     the risks and benefits of this approach.~      A standardized, evidence-based approach is currently lacking for patients with peritoneal~     surface malignancy from gastrointestinal origin. A clinical trial with surgical quality~     assurance and modern hyperthermic intraperitoneal chemotherapy incorporating critical~     assessment of disease burden, determinants of complete cytoreduction, treatment-related~     toxicity, quality of life and survival is imperative. Theoretically, cytoreductive surgery is~     performed to treat macroscopic disease, and hyperthermic intraperitoneal chemotherapy is used~     to treat microscopic residual disease with the objective of removing disease completely in a~     single procedure.~   "
116689|NCT02040129|"~     This study was conducted to evaluate changes of reduction of corneal astigmatism with toric~     intraocular lens(IOL) in congenital cataract.~   "
116690|NCT02040116|"~     The purpose of this study is to evaluate the impact of rapid infusion rituximab on the~     incidence of infusion-related reactions in patients with Autoimmune Diseases.~   "
116691|NCT02040103|"~     Patients admitted to the intensive care unit are at high risk of developing clots in the~     veins of the lower extremities. The objective of this study is to examine whether the use of~     a device that provides intermittent compression to the legs in addition to the use of~     low-dose blood thinners, provides an additional protection when compared to the use of blood~     thinners alone. Patients who are admitted to the intensive care unit are receiving low-dose~     blood thinners to prevent clots are candidates for this study. Patients who are enrolled will~     continue to receive blood thinners but some will additionally receive the leg compression.~     The additional use of leg compression may provide protection from clots. The main side effect~     is possible skin abrasions but this is usually mild. The study is sponsored by King Abdullah~     International Medical Research Center(KAIMRC) and King Abdulaziz City for Science and~     Technology(KACST) and will be conducted in several hospitals in Saudi Arabia, Canada,~     Australia, Brazil and possibly other countries. The study started July 2014 and is to~     continue for 4 years.~   "
116692|NCT02040090|"~     The purpose of this study is to: 1. Evaluate the safety and tolerability of KamRAB in~     comparison with HRIG comparator product. 2. To assess whether KamRAB interferes with the~     development of self active antibodies when given simultaneously with active rabies vaccine,~     as compared to the HRIG comparator product, also given in conjunction with the active rabies~     vaccine.~   "
116693|NCT02040077|"~     Unintentional fatal drug overdose (OD) is now the 2nd leading cause of accidental death in~     the general population. Fatal OD from opioid analgesics specifically has increased over 400%~     between 1999 and 2008, and nonfatal overdose occurs at a rate 3-7 greater than fatal OD.~     Unintentional opioid OD is a public health crisis in several societal populations including~     drug users, patients being treated for chronic pain, elderly individuals, adolescents, and~     children. Educational interventions have been developed to increase knowledge regarding~     opioid OD risk factors, symptoms, and appropriate responses, however no randomized controlled~     evaluations of these interventions have been conducted. Within-subject evaluations report~     immediate and sustained increases in participant knowledge and behavior change, yet these~     programs suffer from limitations that may limit their widespread dissemination. Thus, there~     is an urgent, critical need to develop an opioid OD educational intervention that can be~     accessed by a broad audience, and produces immediate and sustained gains in knowledge in an~     easily administered and cost-effective way. This study will develop a web-based,~     computerized, interactive, opioid OD education training program that will incorporate~     multi-media learning components and fluency training to produce knowledge gains. This program~     will be evaluated using a randomized, controlled comparison of the active intervention~     against two control interventions. Participants will be recruited from a brief inpatient~     detoxification (n=75), will receive the intervention immediately upon completing the~     detoxification (post-treatment), and will complete 2 follow-up visits to evaluate sustained~     knowledge. The primary outcome will be percent change from baseline on a knowledge test that~     is administered immediately before and after the intervention, and at a 1 and 3-month~     follow-up visit. Secondary outcomes will include self-reported behavior change and~     participant acceptance of the intervention. The study hypothesis is that participants who~     receive the primary intervention will evidence the largest increase in knowledge gain and~     retention over time, compared to the control groups. The rationale and public health benefit~     of this research cannot be understated- this project will make available a brief,~     empirically-supported intervention that can be administered quickly and easily within~     hundreds of settings (e.g., treatment centers, prisons and jails, needle exchange centers,~     primary care offices, schools), and to diverse patient populations (e.g., drug users, chronic~     pain patients, elderly, student, children, parents). These outcomes are expected to have a~     positive impact because they will provide cheap, easily-administered intervention strategy~     that will help reduce the current national epidemic of opioid OD, and will expand the use of~     computerized interventions to address public health issues more broadly.~   "
116694|NCT02040064|"~     This is an open-label phase 1, safety, PK, and preliminary efficacy study of oral Gefitinib~     and IV Tremelimumab in previously treated NSCLC patients who have documented evidence of an~     activating mutation in the EGFR gene and have failed treatment with an EGFR inhibitor such as~     Erlotinib or Gefitinib. The primary objective of this phase I, is to determine the safety and~     tolerability of oral Gefitinib in combination with escalating doses of Tremelimumab and to~     establish a recommended phase 2 dose. Secondary objectives include evaluation of,~     pharmacokinetics, immunogenicity, antitumor activity of Gefitinib and Tremelimumab~     combination. The exploratory objectives are to evaluate biomarkers that may correlate with~     activity or prospectively identify patients likely to respond to Tremelimumab and Gefitinib.~      The biological rationale for such a study is that even though the disease is progressing it~     is likely that EGFR sensitive clones, although diminished under the pressure from the EGFR~     TKI, are still present. Therefore, withdrawing the inhibitory pressure of the EGFR TKI can~     potentially allow regrowth of the EGFR sensitive cells. On the other hand, the proliferation~     of EGFR resistant clones needs to be suppressed by another therapeutic approach. Until today~     no association of chemotherapy and TKI EGFR has demonstrated clinical benefit. Moreover,~     patients may have received chemotherapy and the likelihood of chemosensitivity is very low.~     So, the association of Gefitinib with immune checkpoint blockade is very attractive and may~     result in clinical benefit in NSCLC with EGFRmut.~   "
116695|NCT02040051|"~     The purpose of this study is to assess the effect of sound insulation and music therapy on~     the comfort of mechanically ventilated patients admitted to intensive care unit measured by~     the Bispectral Index (BIS), the Ramsay sedation scale and the Behaviour Pain Scale (BPS)~   "
116697|NCT02040025|"~     The purpose of this proposed Department of Defense study is to evaluate the effect of~     Enhanced External Counterpulsation (EECP) on circulation, blood glucose control and blood~     pressure of type 2 diabetic patients receiving EECP therapy.~   "
116698|NCT02040012|"~     Objectives:~      Primary Objectives~        -  To investigate the safety and tolerability of single ascending doses of AZP- 531 in~          healthy volunteers.~        -  To investigate the safety and tolerability of single and multiple ascending doses of~          AZP-531 in overweight/obese volunteers.~        -  To investigate the safety and tolerability of single and multiple ascending doses of~          AZP-531 in patients with type 2 diabetes mellitus.~      Secondary Objectives • To determine the plasma pharmacokinetic (PK) profile of AZP-531 after~     single and multiple doses.~      Exploratory Objectives~      • To obtain exploratory data on the effects of AZP-531 on the pharmacodynamic (PD) markers of~     blood glucose, interstitial glucose, insulin, and plasma acylated ghrelin (AG) and unacylated~     ghrelin (UAG)~   "
116699|NCT02039999|"~     Despite its commonplace use in respiratory medicine the mechanism whereby inhalation~     challenge with a variety of mild acid aerosols produces a dose related and predictable cough~     is unknown. In this proposal the investigators wish to use established cough challenge~     methodology to explore the mechanism of action of agents provoking cough both in health and~     disease.~      The hypotheses to be tested include:~        -  Intracellular changes in pH, rather than extracellular changes, are key in the~          activation of TRP receptors, the main sensor for provoking cough.~        -  ATP acting through P2X channels is the mechanism of increased nerve excitability~          underlying cough hypersensitivity.~   "
116700|NCT02039986|"~     This study is aimed at better understanding the impact of ivacaftor upon insulin and incretin~     secretion and glucose tolerance in patients with Cystic Fibrosis with a glycine (G551D)~     mutation. Investigators hypothesize that treatment with ivacaftor improves insulin secretion~     in individuals with CF.~   "
116701|NCT02039973|"~     Although there is a significant burden of depression among HIV-positive women in Tanzania,~     there is a critical gap between the needs of this population and the integration of mental~     health and PMTCT-plus services. The long-term intent of the research is to bridge this gap~     with the overall goal to examine the potential for successful integration of enhanced mental~     health care and brief group interventions among HIV-positive women receiving PMTCT-plus~     services and to evaluate a combination of evidence-based approaches for treatment of~     depression in this vulnerable population in Tanzania.~   "
116702|NCT02039960|"~     Bupropion hydrochloride was first approved on 30 December 1985 in United States for~     depression and is currently approved in 80 countries. Bupropion has also subsequently been~     approved for smoking cessation and for seasonal affective disorder.~      Cumulative exposure to bupropion is estimated at approximately 97.3 million patient exposures~     up to 31 December 2012.~      Bupropion hydrochloride is a weak catecholamine reuptake inhibitor predominantly affecting~     serotonin, norepinephrine and dopamine. Its mechanism of action and its structural~     similarities to diethylpropion, amphetamines, and cocaine, bupropion resembles stimulants in~     many respects, leading to concerns about potential abuse of the product.~      Abuse potential had been part of the Benefit Risk Management Plan for bupropion up until 2003~     and at that point, had no longer been regarded as a potential risk that required~     additional/further evaluation outside standard pharmacovigilance monitoring. The current~     European Risk Management Plan also states that standard pharmacovigilance monitoring applies~     to abuse potential. Monitoring has shown a recent increase in the number of spontaneous~     reports from the Adverse Event reporting System (AERS) of drug abuse.~      The bupropion team agreed that although the numbers of abuse reports was small relative to~     the total number of reports for bupropion in OCEANS, there was sufficient information in AERS~     to warrant investigation of the potential effect on public health.~      To investigate the degree of misuse and abuse of bupropion (including non-oral routes of~     administration) in the United States, the Drug Abuse Warning Network will be used to examine~     the study period 2004-2011.~   "
116703|NCT02039947|"~     This is a multi-cohort, open label, Phase II study with Dabrafenib (GSK2118436) and~     Trametinib (GSK1120212) combination therapy in subject with BRAF mutation-positive melanoma~     that has metastasized to the brain. This study will evaluate the safety and efficacy of 4~     cohorts. Cohorts will consist of; V600 E, D, K, R mutations, metastases to the brain,~     symptomatic and asymptomatic, with or without prior local (brain) therapy, with or without~     prior local (brain) therapy, and range of ECOG scores from 0-2.~   "
116704|NCT02039934|"~     High intensity interval training is applied for several diseases.~      Hypothesis: High intensity interval training improves insulin sensitivity in patients with~     type 2 diabetes.~   "
116705|NCT02039921|"~     The study aims to describe the changes of combination antiretroviral therapy and the causes~     that motivated them.~   "
116706|NCT02039908|"~     Although stimulant medication is a well-established treatment for ADHD, it is often necessary~     for doctors to increase the dose over time to maintain the benefits of the medication. While~     medication can be very effective for improving symptoms of ADHD during the first year of use,~     it has not been found to significantly improve the long term course of children with ADHD.~     For example, in large research studies, groups of children who take medication for ten years~     do not have consistently better academic grades than groups of children who never used~     medication (individual results will vary from child to child).~      In order to help children with ADHD achieve the best possible outcomes, it is important for~     doctors to study why this happens. One possible reason is development of tolerance to the~     medication. Tolerance means that a drug's effects decrease when it is taken consistently over~     time, so that an increased dose is needed to continue showing effects. Some doctors believe~     that children who take stimulant medication for ADHD develop tolerance to it which would~     explain why benefits may not persist over time, but no research studies have been done to~     measure whether this occurs. This study aims to see if children show a tolerance effect to~     stimulant medication and whether that tolerance can be prevented by taking short breaks from~     the medication called medication holidays.~   "
116739|NCT02039479|"~     The primary hypothesis of this confirmatory study is that lithium therapy will acutely~     decrease suicidal ideation and/or suicidal behaviour in inpatients with a major depressive~     episode (MDE, unipolar and bipolar disorder according to DSM IV criteria). The specific aim~     is to test the hypothesis that lithium plus treatment as usual (TAU), compared to placebo~     plus TAU, results in a significantly greater decrease in suicidal ideation and/or behaviour~     over 5 weeks in inpatients with MDE.~   "
126727|NCT01908712|"~     The overall objective of this trial is to provide aftercare treatment with Lamazym and to~     evaluate the safety of repeated Lamazym i.v. treatment of subjects with alpha-Mannosidosis~     whom previously participated in Lamazym-trial.~   "
116707|NCT02039895|"~     Radiation therapy, Total skin electron beam therapy (TSEBT), achieves a high response rate~     and is an effective treatment for cutaneous T-cell lymphoma affecting the superficial region.~     One the most widely used TSEBT techniques consists of six dual fields initially developed at~     Stanford University. However, deviations occur from the prescription dose up to 40% and the~     surface dose inhomogeneity as much as 90% in body areas such as the perineum and eyelid.~      Helical tomotherapy (HT) has advantages in irradiating extended volumes with treatment length~     of up to 160 cm, continuously in a helical pattern without the need for field junction. Using~     HT, an image-guided intensity-modulated radiotherapy, to replace conventional TSEBT technique~     to increase dose delivery and decrease toxicities possibly. Recently, we published the~     possibility of helical irradiation of the total skin (HITS) by physical proving and showed~     the clinical results of HITS successfully for a woman with T cell lymphoma failure by~     chemotherapy, topic UV irradiation and local radiotherapy (RT) to overcome the surface dose~     inhomogeneity by conventional RT.~      Here, investigators will enroll the stage I-IV cutaneous T-cell lymphoma (CTCL) of~     International Society Cutaneous Lymphomas (ISCL)/U.S. Cutaneous Lymphoma Consortium~     (USCLC)/European Organization for Research & Treatment of Cancer (EORTC), patients who are~     candidates for TSEBT by recommendation of National Comprehensive Cancer Network Guidelines~     (Version 4.2011, Mycosis fungoid/Sezary syndrome) or who are refractory or not feasible to~     the topic UV irradiation, Interferon alpha, psoralen plus ultraviolet A photochemotherapy,~     and Accutane® (Isotretinoin) or chemotherapy to receive HITS to replace TSEBT. Additionally,~     we will compare the advantages and disadvantages between the plan of HT and conventional RT~     for TSEBT.~   "
116708|NCT02039882|"~     Acute coronary syndrome is defined as myocardial infarction or ischemia as evidenced by~     significant coronary artery disease on cardiac catheterization/revascularization or~     reversible defect seen on stress test. Each year approximately 8-10 million patients undergo~     an emergency department evaluation for possible acute coronary syndrome (ACS) in the United~     States Up to 8%of patients who have myocardial infarction (MI) are inadvertently discharged.~     Unnecessary admissions for presumed myocardial disease result in health care costs that are~     estimated to exceed 5 billion dollars annually Currently, the cardiac biomarkers troponin and~     Creatine phosphokinase (CPK-MB), in conjunction with ECG changes are used to evaluate a~     patient routinely for ACS. However, these tests have limitations for identifying most~     patients who have ACS in a rapid fashion. Purine molecules such as inosine and hypoxanthine~     and have been shown to also be biomarkers of acute MI. High pressure liquid chromatography~     (HPLC) is the traditional method of analysis of these purines. The HPLC method however~     requires hours to assess biomarkers, as do the more traditionally used troponin and CK-MB~     methods.~      Recently, the investigator has developed a rapid chemo luminescence method for detecting~     purine biomarkers. This modality can provide an expeditious (requires less than 4 minutes to~     complete analysis), bedside method of analysis for ACS through routinely acquired blood~     samples. In this study the investigator will compare the results of the chemo luminescence~     method with the gold standard HPLC method, and results of the traditional cardiac markers~     troponin and Creatine phosphokinase (CK-MB) in patients undergoing an evaluation for ACS.~     Details of noninvasive and invasive cardiac assessments performed as part of the routine~     evaluation by the clinician for myocardial assessment and intervention in conjunction with~     biomarker assessment will be obtained. The investigator hypothesize that the rapid chemo~     luminescence biomarker assessment will identify patients with ACS faster than traditional~     diagnostic methods.~      The goal of this study is to assess the role of rapid assessment of purine biomarkers in~     identifying patients who may have ACS.~   "
116709|NCT02039869|"~     The purpose of this study is to find out if people who have non-erosive reflux disease (NERD)~     have changes the investigators can see with a microscope (called confocal endomicroscopy)~     that is used during endoscopy (a camera scope evaluation of the inside of your stomach and~     swallowing tube). Traditionally the investigators have used trials of acid blocking~     medications (PPIs), endoscopy and measurements of acid in the swallowing tube (the esophagus)~     to determine if the investigators think acid is causing troublesome symptoms. The medical~     community believes that these symptoms are due to increased spaces between the cells that~     make up the swallowing tube. The investigators can directly see those spaces with a new~     microscope that the investigators can pass through the camera scope.~      Participants will be assigned to take one of two medications omeprazole and sucralfate (both~     approved medications for stomach symptoms) to treat their symptoms and record how well the~     treatment works. The investigators then will look to see if the microscope can predict which~     medication will work best for patients in the future. The investigators also plan to measure~     the acid levels in your swallowing tube and do a camera evaluation of your swallowing tube~     and stomach as this is standard for patients with your symptoms. The investigators will~     compare the results of those studies to the microscope findings.~   "
116710|NCT02039856|"~     VA has undertaken a major initiative to transform care through implementation of Patient~     Aligned Care Teams (PACTs). Based on the patient-centered medical home (PCMH) concept, PACT~     aims to improve access, continuity, coordination and comprehensiveness using team-based care~     that is patient-driven and patient-centered. However, how VA should adapt PACT to meet the~     needs of special populations, such as women Veterans, is yet to be worked out. The main goal~     of this study is to develop and test an evidence-based quality improvement (EBQI) approach to~     adapting and implementing PACT for women Veterans, incorporating comprehensive women's health~     care in gender-sensitive care environments, thereby accelerating achievement of PACT tenets~     for women Veterans and reducing persistent gender disparities in VA quality of care.~   "
116711|NCT02039843|"~     Service Dogs are trained to assist people with disabilities to accomplish tasks which permit~     the individual to be more functional in their home and social environment. Often the dogs are~     trained to help in the completion of activities of daily living and instrumental activities~     of daily living. Service Dogs are efficacious for individuals with disabilities, such as~     vision limitations, spinal cord injury and hearing problems. In addition, some mental health~     outcomes have improved with the introduction of a Service Dog. A research study was mandated~     in the Department of Defense Bill of 2010, to examine the efficacy of service dogs for~     Veterans with Post Traumatic Stress Disorder (PTSD). Together with the Cooperative Studies~     Program, the proponents have designed a research study to effectively meet the demands of the~     Bill and to provide timely research into an evolving field.~   "
116712|NCT02039830|"~     The recommended treatment for urinary incontinence (UI) in women is individualised pelvic~     floor muscle (PFM) training, a costly and resource-intense approach; one Canada is currently~     unable to meet. This non-inferiority randomized control trial seeks to determine if~     group-based PFM training is as effective as individualised PFM training for treating UI in~     women 65 and over, and to establish the cost-effectiveness of both. Demonstrating that~     group-based treatment is at least as good as individualised one-on-one treatment and more~     cost-effective would warrant including group-based PFM training as a first-line UI treatment.~   "
116713|NCT02039817|"~     This is an open-label, parallel-group study to compare the pharmacokinetics and~     pharmacodynamics of IDN-6556 following a single 50 mg oral dose of IDN-6556 in subjects with~     severe renal impairment and matched healthy volunteers with normal renal function.~   "
116740|NCT02039466|"~     Postoperative pulmonary complications following abdominal surgery are frequent and associated~     with increased morbidity and mortality and hospital length of stay. Pressure controlled~     ventilation will improve oxygenation indices , hemodynamics during anesthesia for~     laparoscopic colectomy, decreasing postoperative pulmonary complications.~   "
116714|NCT02039804|"~     Trochanteric pain can be caused by osteoarthritis of the hip, fracture, tendinitis, nerve~     pathology and trochanteric bursitis. Trochanteric bursitis is often seen at the outpatient~     clinic and is characterized by chronic lateral hip pain in the vicinity of the trochanter~     major, overlying the lateral aspect of the hip. When pain is persistent after conventional~     therapies, anesthetic and corticosteroid (CS) injections can provide short term to~     intermediate relief of pain, but relapse is common. Only one retrospective study showed the~     efficacy of intra-bursal trochanteric injections with HA and CS. They concluded that the pain~     release is significant with large effect sizes for both treatment. However, the efficacy of~     CS appeared to be short lived and it was shown that the efficacy of HA at 6 and 12 months is~     significant compared to CS (p<0.05).~      In this study we want to compare the efficacy of corticosteroids and hyaluronic acid in the~     treatment of trochanteric bursitis.~   "
116715|NCT02039791|"~     Nimotuzumab is a humanized monoclonal antibody against epidermal growth factor receptor~     (EGFR). Clinical trials are ongoing globally to evaluate Nimotuzumab in different~     indications. Nimotuzumab has been approved to treat squamous cell carcinoma of head and neck~     (SCCHN), glioma and nasopharyngeal carcinoma in different countries. The clinical phaseⅡtrial~     is designed to assess the resection rate and pathological complete response of nimotuzumab~     plus carboplatin and paclitaxel in patients with cervical cancer.~   "
116716|NCT02039778|"~     There are preliminary studies that suggest that radiation therapy to areas of the brain~     containing cancer stem cells (in addition to the area where the tumor was surgically treated)~     may help patients with high-grade brain tumors live longer. The purpose of this study is to~     determine whether the addition of stem-cell radiation therapy to the standard chemoradiation~     will further improve the outcome. The investigators will collect information about the~     patient's clinical status, disease control, neurocognitive effects, and quality of life~     during follow-up in our department.~      The purpose of the study is to improve the overall survival patients with newly diagnosed~     malignant brain tumors treated with stem cell radiation therapy and chemotherapy. The~     investigators will also measure how patients treated with this novel method of radiation~     therapy do over time in terms of disease control, potential neurocognitive side effects,~     overall function, and quality of life.~   "
116717|NCT02039765|"~     To characterize the plasma pharmacokinetics and safety profile of brimonidine following a~     single dose and 4 times per day (QID) dosing of brimonidine tartrate ophthalmic solution~     0.025% for 7 days in healthy, adult subjects.~   "
116718|NCT02039752|"~     The purpose of this study is to evaluate long-term prognoses of patients with multivessel~     coronary disease treated medically or surgically or percutaneously in real world practice.~   "
116719|NCT02039739|"~     The purpose of this study is to evaluate effectiveness and safety of Orsiro™ Drug Eluting~     Stent in Routine Clinical Practice~   "
116720|NCT02039726|"~     The primary objective of the study is to determine whether quizartinib monotherapy prolongs~     overall survival (OS) compared to salvage chemotherapy in subjects with FMS-like tyrosine~     kinase 3 - Internal Tandem Duplication (FLT3-ITD) positive AML who are refractory to or have~     relapsed within 6 months, after first-line AML therapy.~   "
116721|NCT02039713|"~     The purpose of this study is to evaluate effectiveness and safety of DESyne in Routine~     Clinical Practice~   "
116722|NCT02039700|"~     This study will assess the absolute bioavailability of a single oral dose of lesinurad and~     evaluate the pharmacokinetic (PK) parameters of lesinurad and [14C]lesinurad in healthy adult~     male subjects.~   "
116723|NCT02039687|"~     The purpose of this study is to determine whether ARA 290, a new class of compound, is~     effective in the treatment of the neuropathic symptoms of sarcoidosis. Brief interaction of~     ARA 290 with the innate repair receptor results in anti-apoptotic and anti-inflammatory~     activities in myriad of cells, tissues and organs throughout the body to activate repair~     mechanisms and accelerate healing, including the nerve damage that can be associated with~     sarcoidosis. In this study, subjects with sarcoidosis and symptoms of small fiber neuropathy~     will administered ARA 290 or placebo by subcutaneous injection daily for 28 days. In addition~     to monitoring the safety of the treatment, the symptoms of the subjects will be assessed with~     several questionnaires, function tests, and measurement of nerve fibers in their cornea and~     skin (via a non-invasive test and a biopsy, respectively). The total participation time for~     each patient will be 16 weeks.~   "
116724|NCT02039674|"~     The purpose of this study is to determine the safety, tolerability, and efficacy of~     pembrolizumab (MK-3475) in combination with chemotherapy or immunotherapy in participants~     with unresectable or metastatic non-small cell lung cancer (NSCLC).~   "
116725|NCT02039661|"~     The effect of lidocaine spray on pain relief during endometrial sampling.~   "
116726|NCT02039648|"~     Periodontitis is a biofilm depended oral infection. It leads to inflammatory destruction of~     periodontal tissues and if left untreated to tooth loss. Porphyromonas gingivalis (P.g.) is~     one of the major pathogens associated with the onset and progression of periodontitis.~     Previous in vitro studies have shown that a proanthocyanidin-enriched extract from Rumex~     acetosa L. inhibits the adhesion of P.g. and acts in a cytoprotective manner. Since the the~     bacterial adhesion to oral mucosa cells is a pivotal step for the P.g. mediated tissue~     destruction, its inhibition may be helpful in preventing the colonization with P.g. or its~     eradication in P.g. infected patients. Therefore, the aim of this controlled, randomized and~     double blinded study was to analyze the effects of a Proanthocyanidin-enriched extract from~     Rumex acetosa L. on the intraoral colonization with Porphyromonas gingivalis in individuals~     harboring P.g. intramurally.~   "
116727|NCT02039635|"~     Korean Red Ginseng may improve fatigue in healthy subject. It is not yet known whether Korean~     Red Ginseng is effective compared with a placebo in chemotherapy.~      The purpose of this study is to determine whether Korean Red Ginseng is effective in the~     treatment of the fatigue from colorectal cancer with chemotherapy.(modified FOLFOX-6)~   "
116728|NCT02039622|"~     The study is multicenter, post-authorization, observational and ambispective~   "
116760|NCT02039206|"~     To test the effects of low frequency deep rTMS using the novel HCERMJD-coil on cerebellar~     deficits in patients with SCA3 and to establish its safety in this population.~      Investigator is anticipate that stimulation of the cerebellum with the novel HCERMJD-coil may~     induce significantly therapeutic effects in patients with SCA3 and will pave the way for~     establishing a novel and effective treatment for this disorder.~   "
116729|NCT02039609|"~     In the post-genomic era, a major challenge for health research is to understand the complex~     interactions among genetic, environmental and lifestyle factors including dietary intake.~     Unfortunately, such initiatives are hampered by the lack of accurate dietary intake~     assessment methods for large studies. The newly emerging field of metabolomics offers unique~     possibilities to characterize individual food intake, dietary patterns and effects of dietary~     intervention in large studies. The investigators propose to develop a platform to detect~     broad metabolomic responses to food intake in controlled trials as well as to use targeted~     metabolomics approaches to characterize dietary intake in longitudinal studies. Our~     laboratory has a long history of developing methodology for assessing nutritional status and~     effects of diet on metabolism. Here, the investigators team up with the Sahlgrenska Academy~     Core Facility and the Swedish NMR Centre at the University of Gothenburg, that offer modern~     metabolomics equipment and competence in bioinformatics, and use this in the context of~     nutrition research. To their knowledge, the investigators are among the first groups in the~     country to develop skills in metabolomics to assess dietary intake and effects of nutrition~     on metabolism, and probably the first to use two complementary platforms with both~     mass-spectrometry and nuclear magnetic spectroscopy. Hence, our methodological results should~     be useful to nutritional scientists nationally as well as internationally.~   "
116730|NCT02039596|"~     In the post-genomic era, a major challenge for health research is to understand the complex~     interactions among genetic, environmental and lifestyle factors including dietary intake.~     Unfortunately, such initiatives are hampered by the lack of accurate dietary intake~     assessment methods for large studies. The newly emerging field of metabolomics offers unique~     possibilities to characterize individual food intake, dietary patterns and effects of dietary~     intervention in large studies. The investigators propose to develop a platform to detect~     broad metabolomic responses to food intake in controlled trials as well as to use targeted~     metabolomics approaches to characterize dietary intake in longitudinal studies. Our~     laboratory has a long history of developing methodology for assessing nutritional status and~     effects of diet on metabolism. Here, the investigators team up with the Sahlgrenska Academy~     Core Facility and the Swedish NMR Centre at the University of Gothenburg, that offer modern~     metabolomics equipment and competence in bioinformatics, and use this in the context of~     nutrition research. To their knowledge, the investigators are among the first groups in the~     country to develop skills in metabolomics to assess dietary intake and effects of nutrition~     on metabolism, and probably the first to use two complementary platforms with both~     mass-spectrometry and nuclear magnetic spectroscopy. Hence, our methodological results should~     be useful to nutritional scientists nationally as well as internationally.~   "
116731|NCT02039583|"~     The purpose of this study is to investigate whether there has been a change in low birth~     weight and perinatal and infant mortality following the July 2007 introduction of a ban on~     smoking in public places and workplaces in England.~   "
116732|NCT02039570|"~     This case series aims to find out in a group of female patients suffering from haemorrhoids,~     how many of them have pelvic vein reflux that feeds into their haemorrhoids.~      This will be done by examining their ovarian and internal iliac veins for reflux, using a~     transvaginal scan.~   "
116733|NCT02039557|"~     This is an observational study that will monitor clinical outcomes of patients who have~     received a NiCord®/CordIn™ transplant as part of a GC clinical interventional study and meet~     the eligibility criteria for this Long Term Follow Up study.~   "
116734|NCT02039544|"~     A Randomized, Parallel-controlled, Clinical Study to Evaluate the Efficacy of Xuebi~     Prescription Compared With Placebo in the Treatment of Diabetic Peripheral Neuropathy(Qi~     Deficiency and Blood Stasis)~   "
116735|NCT02039531|"~     HYPOTHESIS:~      The application of plasma rich in growth factors (PRGF) will improve the quality of life and~     functional capacity of patients diagnosed with knee osteoarthritis, providing better~     functional results than conventional treatment with viscosupplementation.~      OPERATING ASSUMPTIONS~      Following the initial administration of three doses of PRGF interspersed every 15 days,~     applied via intraarticular, patients will present an improvement in functional test (WOMAC~     and Lequesne scales) of 15% or more after 6 and 12 months compared to the control group with~     patients treated with hyaluronic acid.~   "
116736|NCT02039518|"~     The purpose of this study is to Evaluate and compare safety and efficacy of Gemcitabine~     Maintenance Treatment in Patients With Extensive SCLC Patients Receiving Etoposide Combined~     With Platinum Based First-line Chemotherapy~   "
116737|NCT02039505|"~     This study is a phase 3, multicenter, randomized, double-blinded, placebo-controlled,~     parallel-group study to examine the efficacy, safety, and pharmacokinetics of MLN0002~     (Vedolizumab) in induction and maintenance therapy in Japanese patients with moderately or~     severely active ulcerative colitis.~   "
116738|NCT02039492|"~     Background: In hypertension, a highly prevalent disease, up to 10-15% of hypertensive~     patients have uncontrolled blood pressure despite a regimen of ≥ 3 drugs, which is known as~     resistant hypertension (RH). Cardiovascular prognosis in patients with RH is worse than in~     controlled hypertensives. Efferent renal sympathetic nerves play an important role in volume~     homeostasis and blood pressure. A novel minimally invasive technique based on the use of~     selective radiofrequency renal sympathetic denervation has shown promising preliminary~     results for the treatment of these patients. On the other hand, some patients with RH could~     improve their blood pressure control by adding spironolactone, an antagonist of aldosterone~     receptors.~      Objective: To evaluate the efficacy of radiofrequency renal sympathetic denervation in~     patients with RH, as compared with the addition of spironolactone to the therapeutic regimen~     at baseline.~      Method: interventional, prospective, randomized, open study, of a cohort of 50 patients with~     RH, with office systolic blood pressure ≥ 150 mmHg and also with 24h systolic blood pressure~     ≥ 140 mmHg, despite treatment with ≥ 3 drugs in adequate doses, one of them a diuretic, and~     whitout treatment with either spironolactone or eplerenone. Patients will be randomized (1:1)~     to renal sympathetic denervation treatment or spironolactone (50mg), performing determination~     of office blood pressure and 24h-ABPM at pre-randomization, 1, 3 and 6 months, as well as~     laboratory tests, echocardiography, measurement of carotid intima-media thickness and central~     blood pressure measurement at pre-randomization and after 6 months.~   "
126788|NCT01907906|"~     The purpose of this study is to evaluate radiolabeled recovery and survival of autologous red~     blood cells (RBC), derived from Mirasol-treated fresh whole blood (WB), stored as~     leukoreduced packed RBC (LR-pRBC), and re-infused in healthy adult subjects~   "
116741|NCT02039453|"~     During sedative colonoscopy, use of propofol have been increased world wide. The onset time~     of propofol is shorter than midazolam. However the most popular additive pain killer,~     pethidine show different pharmacodynamic feature. The pethidine has longer onset time than~     propofol (nearly 30 minutes) and require more time to recovery. For this reason, the use of~     fentanyl has been increased world widely. However, exact comparison of pethidine and fentanyl~     was not studied. Therefore, we designed this study to compare both drug to check satisfaction~     of this drug.~   "
116742|NCT02039440|"~     The purpose of this study is to determine whether there are persisting antibodies against~     Japanese Encephalitis 6 years after the last vaccination with IXIARO(R) and to adapt or~     confirm mathematical models accordingly.~   "
116743|NCT02039427|"~     Sore throat is one of most frequent complaints related to general anesthesia with tracheal~     intubation. Although sore throat is regarded as a minor and short-lasting discomfort after~     surgery, its incidence and intensity in high risk patients such as female gender, head and~     neck surgery and difficult laryngoscopy or intubation may attribute to prolong postoperative~     recovery and give patient dissatisfaction.~      Even though the pathophysiology of post-intubation airway symptoms is not completely~     clarified yet, the mucosal damage related inflammation at the cuff of endotracheal tube has~     been thought to be an essential trigger. Thus anti-inflammatory medication has been commonly~     used strategy to prevent postoperative airway discomfort after intubation. The preoperative~     administration of dexamethasone has been reported to reduce the incidence and severity of~     postoperative sore throat, but it is accompanied with the adverse effects such as~     hyperglycemia, delayed wound healing and increased infection in surgical patients. Ketorolac,~     non-steroidal anti-inflammatory drug (NSAID), is an analgesic that commonly used for~     postoperative pain control and has anti-inflammatory effect.~      Therefore, the investigator designed to evaluate the effect of ketorolac on sore throat in~     comparison to dexamethasone after thyroidectomy in female adult patients~   "
116744|NCT02039414|"~     Regular maternal physical activity leads to the delivery of lighter, leaner infants. Higher~     birth weights and childhood obesity are both strong predictors for adult obesity, suggesting~     that the impact of maternal physical activity on the future health of a child is substantial.~     However, the mechanisms underlying the relationships between maternal physical activity and~     improved infant outcomes are unclear. Thus, the purpose of this project is to measure two~     potential contributing factors: maternal fat metabolism and maternal oxidative stress~     profiles. The investigators believe that maternal physical activity leads to beneficial~     alterations in maternal fat metabolism and oxidative stress profiles. Further, the~     investigators believe that both maternal fat metabolism and oxidative stress levels are~     related to infant outcomes such as obesity and insulin resistance. Therefore, exercise will~     improve maternal metabolic factors that can lead to improvements in infant outcomes. The~     investigators will compare these factors between obese inactive pregnant women and obese~     active pregnant women. This study design will allow us not only to determine the effect of~     physical activity on maternal and neonatal pregnancy outcomes, but also to establish whether~     obesity or physical inactivity should be a primary area of focus when prescribing pregnancy~     interventions in clinical practice.~   "
116745|NCT02039401|"~     The purpose of this study is to determine the safety and tolerability of intramuscular~     injections of VM202 at different injection sites in people with amyotrophic lateral~     sclerosis.~   "
116746|NCT02039388|"~     The current study aims at answering the scientific question, whether exfoliated cells from~     STICs get transported into the uterine cavity via the fallopian tube, and whether it is~     possible to detect those cells in the lavage fluid from the uterine cavity and proximal~     fallopian tubes.~      To address this question, the investigators will study 20 lavage samples and their 20~     corresponding STIC-positive tissue samples in women who opt for risk-reducing bilateral~     salpingo-oophorectomy (rrBSO) because of increased risk of high grade serous carcinoma of the~     pelvis (HGSC) (mostly carrying a BRCA mutation), without a history of tubal occlusion for~     sterilization. Women who opt to have the fallopian tubes removed but the ovaries preserved~     are eligible for the study too, as are women who opt for rrBSO plus hysterectomy.~   "
116747|NCT02039375|"~     Intravenous (IV) tissue plasminogen activator (tPA) is the only FDA-approved therapy for~     treatment of acute ischemic stroke. In the United States, IV tPA is typically administered in~     the Emergency Department (ED) for patients presenting with acute ischemic stroke within 4.5~     hours of symptom onset. It is current practice that post-tPA patients are monitored in an~     intensive care unit or intensive care unit (ICU)-like setting for at least 24 hours, in part~     due to frequent vital sign and neurological monitoring that is currently the standard of~     care. However, rigorous evidence to support this practice is largely lacking. In a~     retrospective analysis of 153 patients receiving IV tPA at Johns Hopkins Hospital (JHH) and~     Johns Hopkins Bayview Medical Center (JHBMC), we have shown that most patients who have ICU~     needs in the first 24 hours after tPA administration develop such needs by the end of the tPA~     infusion. Patients without ICU needs by the end of the tPA infusion, do not require further~     ICU resources if their presenting NIH Stroke Scale (NIHSS) is below 10. This study is a~     prospective clinical trial that aims at establishing the first proof-of-concept and~     feasibility of whether patients with a low NIHSS (NIHSS 9 or less) and that do not need ICU~     care by the end of the tPA infusion, can be monitored safely in a non-ICU setting with a~     novel monitoring protocol. Identifying post-tPA patients who can be safely monitored in a~     non-ICU environment may improve cost-effective utilization of ICU resources and reduce the~     length of hospitalization for stroke patients.~   "
116748|NCT02039362|"~     The risk of vertical HBV transmission is related to HBV DNA level in pregnant women, around~     30% in women with HBV DNA above 1, 000 000 I.U/mL despite serovaccination of newborns. Using~     tenofovir DF during the last trimester of pregnancy allows to reduce the risk, but data from~     Western countries are needed.~   "
116842|NCT02038140|"~     The primary objective of this study is to obtain implant survivorship and clinical outcome~     data for commercially available Zimmer Trabecular Metal Total Ankle implants used in primary~     or revision total ankle arthroplasty. The assessment will include implant survivorship and~     clinical performance measured by pain and function, quality of life data, radiographic~     parameters and survivorship.~   "
120453|NCT01990885|"~     The purpose of this study is to evaluate the safety of different amounts of BL-7010 in single~     oral administration and in repeated oral administration to well-controlled celiac patients.~     Another purpose is to evaluate if BL-7010 is absorbed by the body or not.~   "
116749|NCT02039349|"~     Background:~      - Hormones are naturally occurring chemicals in your body. Ghrelin is a hormone that is~     mainly produced by the stomach and stimulates appetite. Some studies suggest it may stimulate~     alcohol craving and use. Drugs have been developed that block ghrelin. Researchers want to~     know if people can tolerate a particular drug that blocks ghrelin. It will be given at two~     dose levels, combined with alcohol.~      Objective:~      - To determine if a drug that may decrease alcohol consumption when given along with alcohol~     is safe and tolerable.~      Eligibility:~        -  Healthy adults 21-65 years old who have 14 (women) to 21 (men) drinks a week.~        -  No one of childbearing potential can participate.~      Design:~        -  Participants will have 3 inpatient clinic visits; each will last 4 days.~        -  They will have physical exam and blood and urine tests.~        -  They will have breath tests for alcohol and smoking.~        -  They will answer health and mood questions.~        -  Researchers will measure their reaction to smelling alcohol and tasting a sweet drink.~        -  They will eat only the food provided by the clinic. They will keep a food diary 1 day~          before each stay.~        -  They will be randomly assigned to take the study drug or placebo 5 times each stay.~        -  On Day 3, they will drink alcohol after taking the drug. They will give many blood~          samples that day through a tube inserted in their skin.~        -  Smokers can take smoke breaks. Once, they will smoke a cigarette through a device.~        -  One week after the last stay, participants will have a follow-up visit to answer~          questions.~   "
116750|NCT02039336|"~     This is a phase I/II multi-center open-label proof of concept study, consisting of two parts.~     Part A of this study is designed to identify the recommended phase 2 dose (RP2D) of the~     combination regimen of dacomitinib plus PD-0325901 in patients with advanced KRAS mutant~     (KRASm) non-small cell lung cancer (NSCLC). Part B is designed to perform a randomized~     comparison of the combination of dacomitinib and PD-0325901 versus standard of care therapy~     in patients with advanced KRASm NSCLC. It is hypothesized that with this combination strategy~     the progression free survival of patients with KRASm NSCLC will be doubled.~   "
116751|NCT02039323|"~     The purpose of this study is to determine the feasibility of a novel method to assess~     antiretroviral efficacy for protection against HIV-1 infection in vaginal and cervical tissue~     biopsies.~   "
116752|NCT02039310|"~     The investigators proposes a prospective cohort study in patients with high risk bladder~     cancer who have opted for radical cystectomy. The investigators aim to correlate~     pre-operative measures of body composition, cognitive and functional status with impaired~     survival at 6 months after cystectomy. Impairment in this context will be a compilation of~     several specific objective measures including: 1) death from any cause, 2) major complication~     (Clavien score7 ≥ 3), 3) loss of independent living status, 4) performance status, and 5)~     global well-being. The study team believes that Impairment Free Survival is an important~     endpoint as it accounts for many aspects of a patient's functional status that might alter a~     patient's choice to proceed with radical surgery.~   "
116753|NCT02039297|"~     In this multicenter project, we will introduce AWARE (electronic interface) Using a~     cloud-based technology . The goal of this project is to improve compliance with best practice~     through the use of a new acute care interface with built-in tools for error prevention,~     practice surveillance and reporting (ProCCESs AWARE - Patient Centered Cloud-based Electronic~     System: Ambient Warning and Response Evaluation).The goal of this project is to develop and~     test a novel acute care interface with built-in tools for error prevention, practice~     surveillance, decision support and reporting (ProCCESs AWARE - Patient Centered Cloud-based~     Electronic System: Ambient Warning and Response Evaluation). In preliminary studies, these~     novel informatics supports built on an advanced understanding of cognitive and organizational~     ergonomics, have significantly decreased the cognitive load of bedside providers and reduced~     medical errors. Using a cloud-based technology, AWARE will be uniformly available on either~     mobile or fixed computing devices and applied in a standardized manner in medical and~     surgical ICUs of five geographically diverse acute care hospitals predominantly serving~     Medicare and Medicaid patients. The impact of ProCCESs AWARE on processes of care and~     outcomes in study ICUs; expected to enroll more than 10,000 critically ill patients during~     the study period.~   "
116754|NCT02039284|"~     Cerebral palsy (CP) is the most common childhood motor disability. Weakness, spasticity, and~     loss of dexterity are the major problems in patients with CP. A novel virtual cycling~     training (VCT) program for lower limb was to enhance promising muscle strength through~     promoting the participant compliance and motivation. Sensory electrical stimulation(SES) of~     whole hand is a novel technique and is commonly used to treatment of spasticity for patients~     with stroke. Constraint-induced therapy (CIT) is a method for treating developmental~     disregard and learned non-use of affected limb and improving motor efficiency, functional~     performance, and activities of daily living for patients with CP.~   "
116755|NCT02039271|"~     The aim of the present study is to determine if the use of music as an intervention can be~     utilized, in conjunction with normal pharmacological treatment, in decreasing pain and~     increasing patient satisfaction, in male and female total knee replacement patients, from the~     age of 50 and 70, during the first 48 postoperative hours after surgery. It is the hope that~     this study can add to current research addressing the pain relief needs of orthopedic~     patients following total knee replacement surgery using music listening as an adjuvant~     therapy.~   "
116756|NCT02039258|"~     The purpose of this study is to assess the effect of coadministration of a high-fat meal on~     the oral bioavailability of a fixed dose combination of Canagliflozin/extended release~     Metformin (CANA/MET XR) tablet, containing 150 mg CANA and 1,000 mg extended release MET in~     healthy participants.~   "
116757|NCT02039245|"~     The purpose of this study is to evaluate the multiple dose pharmacokinetics of 2~     Canagliflozin/extended release Metformin (CANA/MET XR) fixed dose combination tablets (150~     mg/1,000 mg each) following once-daily oral dosing in healthy participants.~   "
116758|NCT02039232|"~     The purpose of this study is to evaluate the safety and efficacy of CarboFix' Pedicle Screw~     System in the lumbar spine.~   "
116759|NCT02039219|"~     The main purpose of this study is to test the effectiveness of Obeticholic Acid when used in~     patients with moderately severe alcoholic hepatitis. The researchers suspect that individuals~     with alcoholic hepatitis have certain abnormalities in how their body handles bile acids (a~     product made by the liver on a daily basis) produced by the liver. Obeticholic acid has been~     shown to affect bile acid abnormalities and thus it is possible that obeticholic acid may~     improve liver condition in individuals with alcoholic hepatitis.~   "
116761|NCT02039193|"~     Background: Psychotherapy is an effective treatment for generalized anxiety disorder in~     comparison to no-treatment controls. Instead of creating more and more new overall~     treatment-packets within a medical meta-model, a complementary approach to investigate~     clinical research designs may lie into the understanding of already effective~     psychotherapies. Treatment manuals and protocols allow a relatively high degree of freedom of~     therapists' behaviors on how to implement the overall treatment manuals. There is a lack of~     systematical knowledge of how therapists have to customize these overall protocols. The~     present design experimentally examines 3 types of conducting a 15 session time-limited~     cognitive-behavioral therapy (CBT) protocol and its relation to the therapists' protocol~     adherence and treatment efficacy.~      Methods/design: This trial investigates 3 different types of how to customize a~     well-introduced CBT-protocol using dyadic peer tutoring methodology (primings). The~     individuals with GAD are randomly assigned to 3 priming conditions (resource priming vs.~     supportive resource priming vs. adherence priming). Participants' treatment allocation is~     performed randomly, therapist's assignment to the peer tutoring partner and the priming~     condition is based on mutual agreement. Treatment outcomes are assessed at following levels:~     Observer based in-session outcomes, post-session outcomes from session 1 to 15, treatment~     outcome at post assessment and at 6-months follow-up assessments.~   "
116762|NCT02039180|"~     This is an open-label, randomized, 3-period crossover, single dose study. Three (3) single~     doses of AZD3293 (2 different tablet formulations, and an oral solution) will be administered~     with a washout period of at least 1 week between the doses to investigate the relative~     bioavailability of AZD3293 after administration via 2 tablet formulations compared with oral~     solution and to evaluate basic systemic pharmacokinetic parameters of the tablet formulations~     compared to the oral solution of AZD3293.~      The safety and tolerability of AZD3293 in healthy subjects will also be assessed in the~     study. AZD3293 is being developed for the treatment of Alzheimer's disease~   "
116763|NCT02039167|"~     The purpose of this study is to evaluate the superiority of left atrial appendage occlusion~     in comparison to oral anticoagulation with a vitamin K antagonist (INR 2-3) related to the~     frequency of occurrence of at least one bleeding classified as moderate or major within 24~     months.~   "
116764|NCT02039154|"~     The purpose of this study is to determine whether vigorous exercise training 4-5 days/week~     for 2 years in sedentary middle aged men and women (ages 45-64) will improve cardiac and~     vascular compliance to a degree equivalent to life-long exercisers and the sedentary young.~     Sedentary aging is associated with impaired diastolic function, which can lead to heart~     failure. However, if exercise training can be implemented early enough in life while~     cardiovascular plasticity still exists, then functional capacity can be maintained,~     preventing heart failure.~   "
116765|NCT02039141|"~     The purpose of this study is to examine the effects of 12 week lifestyle intervention on~     diabetes risk in obese Latino adolescents.~   "
116766|NCT02039128|"~     In this double blind, placebo controlled, parallel group study, the relative uptake of 1g/d~     krill oil in comparison to 1g/d fish oil in healthy female and male adults will be assessed.~      Primary objective is to determine if a 12 week supplementation with krill oil increases~     tissue levels in erythrocytes (omega-3 index) significantly more than fish oil after dose~     adjustments to EPA and DHA levels.~   "
116767|NCT02039115|"~     Complete endoscopic resection of early neoplastic Barrett's Esophagus (BE) is a curative~     procedure. However, a significant proportion of patients develop symptomatic esophageal~     strictures following Complete Barrett's Eradication (CBE), and this limits the technique,~     particularly for circumferential and longer segment disease. Oral steroid therapy may reduce~     stricture formation; thereby allowing CBE to be performed with minimal associated morbidity.~   "
116768|NCT02039102|"~     Studies examining the sex differences in the epidemiology and morbidity patterns of asthma~     show that the rates of disease severity, healthcare utilisation, and poor quality of life are~     considerably higher in women than in men, and this has been attributed to endogenous and~     exogenous sex hormonal factors. Studies examining the impact of use of hormonal~     contraceptives on the risk of asthma and asthma-related conditions are few, yet findings are~     conflicting.~      In the present study, the investigators utilize data from the Scottish Health Survey, a~     national representative sample, to investigate the associations between current use of~     hormonal contraceptives and the prevalence of self-reported doctor-diagnosed current asthma~     and wheezing symptoms in Scottish women. The investigators hypothesize that while current use~     of any hormonal contraceptives and combined oral pills are associated with higher prevalence~     of asthma and asthma outcomes, current use of progesterone-only contraceptives is not~     associated with asthma. A secondary aim of the current study is to examine whether there is~     evidence of any biological interaction between use of hormonal contraceptives and BMI in~     relation to the risk of asthma and asthma outcomes.~   "
116769|NCT02039089|"~     This study will be a single-center, multiple-dose, randomized, double-blind,~     placebo-controlled, parallel-group study in healthy male and female subjects. The study will~     consist of 2 parts: Part A (3 cohorts of healthy Japanese subjects dosed in the evening) and~     Part B (one cohort of healthy white subjects dosed in the evening). The cohorts will be~     conducted sequentially. Part A will be started first with the 2.5-mg dose cohort, followed by~     the 10-mg dose cohort and then the 25-mg dose cohort. Part B will be conducted in parallel~     with the 10-mg cohort of Part A, with the possibility of overlap.~   "
116770|NCT02039076|"~     This will be a randomized, open-label, 5-treatment-period study to evaluate the PK and PD of~     avatrombopag following a single administration of avatrombopag in the fed and fasted~     condition, or the fed condition, to healthy Japanese and white subjects. A standard high-fat,~     high calorie breakfast will be used to assess the fed condition.~   "
116771|NCT02039063|"~     This study is a multicenter, open-label, uncontrolled, multiple ascending dose (MAD) study to~     evaluate mainly the safety and tolerability of 12-week repeated intravenous administration of~     E6011. A total of 24 subjects will enroll into four cohorts. Six subjects per cohort will~     receive repeated intravenous administration of E6011.~   "
116843|NCT02038127|"~     Comparison of~        -  Biolimus-eluting stent, Biomatrix, or Biomatrix Flex stent, Biosensors, Singapore~        -  Everolimus-eluting stent, Xience V, or Xience Prime, or Xience Xpedition stent, Abbott,~          USA~        -  Zotarolimus-eluting stent, Endeavor Resolute, or Endeavor Resolute Integrity stent~          Medtronic, USA in patients with coronary artery disease treated with percutaneous~          coronary intervention~   "
116772|NCT02039050|"~     In chronic obstructive pulmonary disease (COPD), the airways of the lungs are narrowed or~     blocked. Bronchodilators are drugs usually delivered through inhalers which help open up the~     airways. Tiotropium is a type of bronchodilator drug known as a long-acting muscarinic~     antagonist (LAMA). For a long time tiotropium was the only available LAMA. More recently, a~     new LAMA called aclidinium has been approved for use in COPD. There are potentially important~     differences between these two medications that might have an impact on the treatment of COPD~     patients.~      In this study we aim to compare the effects of tiotropium and aclidinium in people with COPD.~     The main comparison will be done using a very sensitive breathing test called impulse~     oscillometry~   "
116773|NCT02039037|"~     Chronic nonspecific low back pain is a major health and socioeconomic responsible for a high~     rate of employee absenteeism and reduced functional performance. The use of acupuncture as an~     alternative therapy in the treatment of low back pain and electroacupuncture to enhance the~     treatment has been effective; however, there is little evidence of the effectiveness of one~     over the other.~   "
116774|NCT02039024|"~     The primary objective of this protocol is to investigate the monoaminergic~     (dopamine、serotonin、and norepinephrine ) nervous system and amyloid deposition in Parkinson's~     disease patients with non-motor symptoms (focus on impulse control disorders and dementia) by~     novel 18F-DTBZ and Florbetapir F-18 PET imaging.~      This study will compare the amyloid deposition of brain by florbetapir F-18 PET imaging and~     monoaminergic function by18F- DTBZ PET in NC group, PD group, PDD group, AD group.~      Investigators will also analyze monoaminergic function by18F- DTBZ PET in PDI group.~   "
116775|NCT02039011|"~     Asthma is a common condition which produces a significant workload for general practice,~     hospital outpatient clinics and inpatient admissions. Asthma is caused by inflammation of the~     airways which irritates the muscles around the airways causing them to constrict. The~     mainstay of asthma treatment is inhaled steroids. If the patients' symptoms are still not~     adequately controlled, then a long-acting beta agonist (LABA) inhaler which relaxes the~     muscles in the airways and opens it up is frequently added to the inhaled steroids. Despite~     this, a substantial proportion of asthmatic patients still do not achieve adequate control of~     their symptoms. Recent studies have shown when an alternative inhaler called a long-acting~     muscarinic antagonist (LAMA) is added to a LABA - it reduced the number of asthma~     exacerbations (flare-ups) and improved airway narrowing.~      The mannitol challenge is a test of airway 'twitchiness', an important feature of asthma.~     There have been no previous studies assessing the combined effects LABA and LAMA inhalers on~     mannitol challenge. The mannitol challenge is particularly relevant as it mimics stimuli~     encountered in real life which provoke an asthma attack.~      The investigators propose to directly compare indacaterol, a new once-daily LABA with~     indacaterol plus tiotropium, a once-daily LAMA, as add-on treatment to inhaled steroids in~     persistent asthmatics using the mannitol challenge. The investigators hope that this study~     will help us understand how the combination of a LABA and LAMA might help protect against~     flare-ups.~   "
116776|NCT02038998|"~     Stroke is one of the leading causes of death and disability worldwide. More than 85% of~     strokes are due to blood vessel occlusion resulting in partial destruction of the brain~     parenchyma. Current protocols try to re-establish blood circulation as soon as possible~     through chemical and/or mechanical interventions but new strategies are needed.~      Periodic acceleration (pGz) is a non-invasive method consisting in the application of a~     rocking movement to the patient that ultimately will induce the release of beneficial~     chemicals from the vascular endothelium (the cells lining the inside of the blood vessels).~     Application of pGz in an animal model of stroke resulted in a dramatic reduction of~     associated brain damage.~      This trial will investigate whether stroke patients exposed to pGz experiment significantly~     higher recovery than patients that remained static during their treatment.~   "
116777|NCT02038985|"~     The purpose of this study is to evaluate the use of fluorescence imaging + Indocyanine Green~     (ICG) dye (Firefly), compared to standard white light imaging in 2D and 3D, for accurate~     visual diagnosis of endometriosis during a da Vinci robotically guided endometriosis~     resection procedure.~   "
116778|NCT02038972|"~     To determine if autologous human umbilical cord blood infusion in children with acquired~     hearing loss is safe, feasible, improves inner ear function, audition and language~     development.~   "
116779|NCT02038959|"~     Connect.Parkinson is a randomized comparative effectiveness study, comparing usual care~     enhanced with educational materials to usual care, educational materials, and the delivery of~     specialty care via telemedicine into patient's homes. The study's specific aims are the~     following:~        1. To demonstrate the feasibility of using telemedicine to deliver specialty care into the~          homes of individuals with Parkinson disease who have limited access to care;~        2. To show that such an approach can improve quality of life;~        3. To establish that the telemedicine can enhance the quality of care; and~        4. To demonstrate that this remote approach to care saves time, reduces travel, and~          decreases care partner burden.~   "
116780|NCT02038946|"~     The purpose of this study is to assess the clinical benefit of Nivolumab, as measured by~     independent radiologic review committee (IRRC)-assessed objective response rate (ORR) in~     subjects with FL lymphoma who have failed therapy with both CD20 antibody and an alkylating~     agent.~   "
116781|NCT02038933|"~     The purpose of this study is to determine whether Nivolumab is effective in the treatment of~     DLBCL in patients that have failed or are ineligible for ASCT~   "
116782|NCT02038920|"~     This study is a phase 3, multicenter, randomized, double-blinded, placebo-controlled,~     parallel-group study to examine the efficacy, safety, and pharmacokinetics of MLN0002~     (Vedolizumab) in induction and maintenance therapy in Japanese patients with moderately or~     severely active Crohn's disease.~   "
116783|NCT02038907|"~     The purpose of this study is to select the optimal formulation of the norovirus vaccine from~     different concentrations of virus-like particles (VLP), Aluminum Hydroxide and MPL adjuvant~     (3-O-desacyl-4'-monophosphoryl lipid A) for further development.~   "
116784|NCT02038894|"~     The purpose of this research study is to compare the safety and effectiveness of three~     commonly used techniques for delivering anesthesia during a procedure known as~     esophagogastroduodenoscopy.~   "
117367|NCT02031276|"~     This study is a proof of concept, multi-center, randomized, double-blind, placebo-controlled,~     parallel-group phase 2 dose-ranging study of BI 655066/ABBV-066 (risankizumab), an IL-23 p19~     antagonist monoclonal antibody, in patients with moderately to severely active Crohn's~     disease.~   "
116785|NCT02038881|"~     The main purpose of this clinical trial is to generate additional safety data in a highly~     immunocompromised population. HIV-infected persons are considered excellent candidates to~     represent the highly immunocompromised population for enrolment in this trial. Additionally,~     the immune system's response (protection against smallpox as measured by the amount of~     antibodies produced) following injections of MVA-BN® smallpox vaccine will be evaluated. All~     participants in this trial will be randomly and evenly assigned to one of three groups to~     receive two, three or four injections. Group 1 will receive the standard regime consisting of~     one dose at each vaccination time point, Group 2 will receive two doses at each vaccination~     time point and Group 3 will receive a booster vaccination 12 weeks after the first dose of~     the standard vaccination schedule with MVA-BN® smallpox vaccine. Participation in the trial~     is scheduled to last up to 48 weeks.~   "
116786|NCT02038868|"~     The purpose of this study is to compare the efficacy of ASP4901 with placebo in patients with~     benign prostatic hyperplasia. The safety and tolerability of ASP4901 will also be evaluated.~   "
116787|NCT02038855|"~     Through a grant funded by the National Institute on Drug Abuse (NIDA) the Center for~     Multicultural Mental Health Research at Cambridge Health Alliance is testing a screening and~     intervention project designed to improve the quality of care for Latino patients with~     comorbid mental health and substance use problems. We will first test a screening of comorbid~     problems with patients identified in mental health as well as primary health care. Building~     on that work, we will test the feasibility, acceptability and efficacy of the Integrated~     Intervention for Dual Problems and Early Action (IIDEA) intervention addressing mental~     health, substance use, and prevention of HIV, as well as a smoking cessation supplement. The~     project is being conducted in Massachusetts as well as at two sites in Spain. As such, the~     proposed ILRP multi-site international project is a critical step towards developing models~     of integrated care for the large and diverse Latino migrant population and more broadly~     towards understanding how best to integrate evidence-based assessment and treatments for~     co-occurring substance and mental health problems and HIV risks.~   "
116788|NCT02038842|"~     The development of a safe and effective HIV-1 vaccine strategy would probably be the best~     solution for the ultimate control of the worldwide AIDS pandemic. Heterologous prime-boost~     immunisations are today considered promising HIV prophylactic vaccine strategies. It is thus~     relevant to pursue the development of different candidate vaccines in prime-boost vaccine~     strategies to identify the most promising prime-boost combinations and to integrate~     scientific inquiry into trial protocols from the beginning to maximize learning~     opportunities.~   "
116789|NCT02038829|"~     Study for subjects 40 to 65 years-old with a diagnosis of moderate to severe COPD. Aclidinium~     bromide 400 mcg 2x a day will be given as an active comparator.~   "
116790|NCT02038816|"~     Myelodysplastic syndromes are common blood disorders that can affect as many as one in 1000~     Canadians over the age of 65. They are characterized by low blood counts that require~     frequent blood transfusions. The development of iron overload in these patients is~     inevitable. The iron deposits in vital organs such as the heart and the liver and can lead to~     organ dysfunction. Deferasirox is a well-studied drug that helps remove iron from the body.~     Most people with this disorder die due to progression of their disease to acute leukemia~     through multiple mechanisms. Iron overload in patients with myelodysplastic syndromes has~     been shown to be associated with shorter survival, and potentially a higher chance of~     leukemia. In a certain sub-group of higher risk patients, the drug azacitidine has been shown~     to decrease the chance of progression to leukemia and death from it. Thus, it is presently~     the standard of care for these patients. However, 50% of higher risk patients are still~     unresponsive to this medication, leaving a large group of patients for which other treatment~     options are emergently needed. Given that a large proportion of higher risk MDS patients fail~     to respond to azacitidine, and the evidence that iron deposition may lead to increased~     leukemic transformation, we would like to study whether iron removal from the body with~     deferasirox potentiates azacitidine in its effects on overall survival, as well as the chance~     of leukemia transformation. This question needs to be addressed in a randomized controlled~     trial, and the first step is a preliminary study to determine if the combination of~     azacitidine and deferasirox has any biologic effect. This study will determine whether this~     combination leads to blood count improvement over azacitidine alone. If this drug combination~     ultimately proves more useful than azacitidine alone with respect to survival, this has the~     potential to impact the care of a large proportion of patients with myelodysplastic~     syndromes.~   "
116791|NCT02038803|"~     Inhaled tobramycin is a Cystic Fibrosis Foundation recommended effective treatment for~     individuals with cystic fibrosis for the management of Pseudomonas aeruginosa airway~     colonization and improves the FEV1 and reduces the number of acute pulmonary exacerbations of~     CF. Patients typically use the inhaled tobramycin for a period of 28 days. Unfortunately, the~     standard nebulizer method for delivering tobramycin inhaled solution (TIS) is time-consuming~     and may result in missed therapy doses and suboptimal care. A new inhaled formulation and~     delivery device, the TOBI Podhaler (TPI), is a quicker, more efficient method of~     administering inhaled Tobramycin. This new pocket-sized disposable inhaler is maintenance~     free, requires no refrigeration or power source, and should greatly increase patient mobility~     and improve time management.~   "
116792|NCT02038790|"~     The primary objective of this study is to compare overall patient preference for either~     Suboxone® sublingual film 8/2 or Zubsolv® sublingual tablets 5.7/1.4. Suboxone sublingual~     film 8/2 contains 8mg buprenorphine and 2mg naloxone. Zubsolv sublingual tablets contain 5.7~     mg buprenorphine and 1.4 mg naloxone. Both interventions act as a substitute for opiate drugs~     like heroin, morphine or oxycodone and help withdrawal from opiate drugs over a period of~     time.~   "
116793|NCT02038777|"~     This is an open-label, multi-center, Phase 1 study of PF-04449913 in Japanese patients.~     PF-04449913 will be administered orally as a single agent in patients with select advanced~     hematologic malignancies, or in combination with LDAC [Low-Dose Ara-C] or cytarabine and~     daunorubicin in previously untreated patients with AML [Acute Myeloid Leukemia] or high-risk~     MDS [Myelodysplastic Syndrome], or in combination with azacitidine in previously untreated~     patients with AML.~   "
116794|NCT02038764|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and~     immunogenicity of multiple doses of PF-06342674. Several dose levels will be evaluated.~   "
116806|NCT02038608|"~     Parkinson's disease is characterized by a large number of non motor, especially~     neuropsychiatric, signs. Their pathophysiology is complex but the role of dopaminergic and~     serotoninergic systems dysfunction is suggested by several studies. In addition, the~     serotoninergic system is involved in the pathophysiology of dyskinesias. Very few studies~     have analyzed the abnormalities of these two neurotransmission systems at disease onset, in~     de novo PD patients. Furthermore, the parallel evolution of the degeneration of the~     dopaminergic and serotoninergic systems with disease progression remains unknown. Thus the~     present study aims at determining, by using PET and 11C-PE2I and 11C-DASB the respective role~     of the serotoninergic and dopaminergic systems dysfunction in motor and non motor~     manifestations in PD, at different evolution stages.~   "
116795|NCT02038751|"~     The growing evidence showed that the OSA is a heritable complex genetic disease where the~     genetic basis contributed the development of OSA and its sequel. The phenotyping of OSA~     include high level and intermediate level. The former indicates the AHI, and later includes~     craniofacial morphology, ventilator control, obesity, and sleepiness vulnerability.~      Many studies tried to determine the association of candidate genes with OSA through~     association studies. However, the results were conflicting. We identified 37 candidate genes~     involved in six biologic pathways of OSA reported in previous literatures, including~     oxidative phosphorylation, cell signaling, apoptosis, cellular adhesion and motility, cell~     cycle, and cytokine/chemokine.~      To investigate the association between phenotype and genotype of OSA, we conducted this~     cross-sectional study by recruiting the patients of moderate-severe OSA (index proband) and~     their first and second-degree family members, and friends and their family members (control~     family) and using candidate genes reported in the literature and whole genome SNP array for~     genotype approach.~   "
116796|NCT02038738|"~     Neuroendocrine cancer is an unusual disease and often goes undetected by routine imaging. The~     68Ga-DOTATATE PET Scan is a novel scanning method that may have improved sensitivity and~     resolution specifically for neuroendocrine tumors. Patients with neuroendocrine tumors will~     be imaged with this agent and it will be compared to conventional imaging methods to~     determine the safety and efficacy of this radiopharmaceutical.~   "
116797|NCT02038725|"~     Patients with a transient ischemic attack (TIA) are at high risk of stroke. Rapid assessment~     and treatment can reduce the risk. Several international guidelines recommend a test, the~     ABCD2 score, to identify TIA patients with low and high risk for stroke. The main purpose of~     this study is to investigate stroke risk after TIA in both short (1 week) and long term (3~     months/1 year), and to assess whether the Age, Blood pressure, Clinical features, Duration of~     TIA, Diabetes (ABCD2) score is a sufficient tool for predicting stroke risk. Secondary aims~     are to explore whether adopting imaging modalities (ultrasound, MRI) and biological markers~     of blood into a risk score could improve the predictive value of the ABCD2 score and still be~     feasible in a daily clinical practice. Further on overall risk factors in TIA patients, and~     the incidence of other vascular events will be studied. A substudy designed as a randomised~     controlled trial evaluates pharmaceutical counseling in a subset of participants.~     Cost-benefit analysis, and a long-term follow-up (5 years) is planned.~   "
116798|NCT02038712|"~     Binge Eating Disorder (BED) may be associated with he development of obesity. However, the~     pathogenesis of BED is currently unclear, thus making the development of treatment and~     prevention strategies for BED difficult. Differences in the mechanisms regulating food intake~     may go some way to reveal potential mechanisms for BED.The purpose of this study is to~     investigate the responses of key gut-derived hormones that are associated with the regulation~     of food intake and functional brain activity to food cues using fMRI in BED patients and~     weight matched controls.~   "
116799|NCT02038699|"~     ONC201 is a new potential drug that kills cancer cells but not normal cells in laboratory~     studies. This clinical trial will be the first evaluation of ONC201 in humans and will enroll~     patients with advanced cancer. This trial includes a phase I portion that will evaluate the~     safety of ONC201 and the recommended dose for the phase II portion. The phase II portion will~     evaluate the initial efficacy profile of ONC201 in select types of cancer.~   "
116800|NCT02038686|"~     1. Introduction:~           Controversy exists with regard to whether to treat AO/OTA (Orthopaedic Trauma~          Association) 32.A2 - 32-A3 fractures of the proximal part of the femur with an~          intramedullary short PFN-A or long PFN-A. A prospective, randomized, controlled trial is~          performed to compare the outcome treatment of these unstable fractures of the proximal~          part of the femur with either a short PFN-A (170-240mm) or long PFN-A (300-420mm).~        2. Objectives and Hypothesis The hypothesis is that the Short PFN-A would have fewer~          complications than Long PFN-A~           Main Objective: Is defined as Total number of complications between PFN-A short and~          PFN-A long. Outcome measures were subdivided into preoperative, perioperative and~          post-operative. Follow up data at four weeks, three months and one year.~           Secondary objectives: Complete and uneventful radiological and clinical healing of the~          fracture. Revision operations (related to the failure of primary treatment) and~          mortality. Baseline characteristics were documented pre-operatively: Outcome measures~          were subdivided into intra-operative, post-operative and follow up data at four weeks,~          three months and one year.~        3. Methodology: One hundred and eighty eight patients presenting with an AO/OTA 31-A2 and~          31-A3 fracture of the proximal part of the femur will be randomized, at the time of the~          admission, to fixation with use either a short PFN-A or a long PFN-A.~   "
116801|NCT02038673|"~     The objectives of this study are to determine the tolerability, safety, pharmacokinetics~     (PK), pharmacodynamics (PD), and efficacy of oral ASP5878 in patients with solid tumors.~   "
116802|NCT02038660|"~     The purpose of this study is to evaluate long-term effectiveness and safety of patients with~     coronary disease treated with drug eluting balloon in real world practice.~   "
116803|NCT02038647|"~     This is a two-arm, randomized, double-blind, placebo-controlled, multicenter, phase 2 study~     designed to is to determine if the combination treatment can improve progression free~     survival (defined as the time from the date of randomization to the date of first~     documentation of disease progression or death, whichever occurs first) when compared with~     placebo + paclitaxel.~   "
116804|NCT02038634|"~     The investigators aim to perform a prospective study to evaluate the effectiveness of blind~     corticosteroid injections to US-guided injections for the treatment of de Quervain's disease.~     The results of the study will be used to validate current injection protocols or support the~     incorporation of ultrasonography to treat the disease.~   "
116805|NCT02038621|"~     To confirm the efficacy and safety of XELOX with capecitabine maintenance in treatment of~     advanced gastric cancer (AGC)~   "
116807|NCT02038595|"~     This study seeks to assess a novel imaging technique to image brown adipose tissue utilizing~     the norepinephrine transporter.~   "
116808|NCT02038582|"~     The purpose of this study is to determine efficient, scalable, evidence-based strategies to~     link HIV positive individuals to care and HIV negative individuals to prevention measures,~     such as voluntary male circumcision.~   "
116809|NCT02038569|"~     An international, multi-centre, prospective, non-controlled, open, single-group, 8-week trial~     in adolescent subjects (aged 12 to 16 years, 11 months) with scalp and body psoriasis.~   "
116811|NCT02038543|"~     Primary hyperoxaluria is an inborn error of metabolism that results in marked overproduction~     of oxalate by the liver. The excess oxalate causes kidney failure and can cause severe~     systemic disease due to oxalate deposition in multiple body tissues.~      Metabolic pathways that lead to oxalate are poorly understood, but recent evidence suggests~     that hydroxyproline may play a role. Sources of hydroxyproline include the diet and bone~     turnover. If hydroxyproline can be confirmed as a significant factor in primary~     hyperoxaluria, diet modification might be of value in reducing the severity of disease.~      This protocol, in which hydroxyproline labelled with a cold isotope is infused intravenously~     in patients with primary hyperoxaluria, will allow the researchers to measure the amount of~     oxalate produced from hydroxyproline. The contribution of hydroxyproline metabolism to the~     amount of oxalate excreted in urine in will be able to be determined for patients with each~     of the known types of primary hyperoxaluria.~   "
116812|NCT02038530|"~     This is a cohort study that will assess a new diagnostic management strategy for suspected~     Deep Vein Thrombosis in outpatients.The new diagnostic strategy is designed to reduce the use~     of ultrasound testing on the day of presentation, and reduce repeat ultrasound testing a week~     after an initial normal test.~   "
116813|NCT02038517|"~     This observational study is aimed at assessing insulin secretion and sensitivity by the use~     of a mathematical modeling from oral glucose tolerance test in subjects with liver cirrhosis~     undergoing orthotopic liver transplantation (OLT), before and at various time points after~     OLT.~   "
116814|NCT02038504|"~     The purpose of this study is to investigate whether enteral nutrition are effective in the~     treatment of nonthyroidal illness syndrome among fistula patients.~   "
116815|NCT02038491|"~     Regional anesthesia is the cornerstone of modern postoperative analgesia, but concerns remain~     about possible adverse effects and complication.~      RICALOR Group Investigators developed a national registry to register the incidence of~     regional anesthesia-associated complications and to identify possible risk factors.~   "
116816|NCT02038478|"~     The design of the study incorporates the following features:~        1. This is a phase II study to determine the safety and therapeutic potential of a new~          transplant approach (disease-free survival, graft versus myeloma effect) and to evaluate~          its toxicity profile (immediate toxicity, graft-versus-host disease, graft rejection,~          mortality) in a patient population with severe congenital anemias.~        2. The patient cohort to be studied: Those patients with severe sickle cell disease and~          thalassemia who have risk factors for high mortality and morbidity related to their~          disease~        3. Transplant Conditioning Regimen - Immunosuppression without myeloablation: Patients will~          receive conditioning sufficient to allow donor lympho-hematopoietic engraftment without~          complete marrow ablation. If the graft is rejected, the patient will reconstitute~          autologous marrow function. We will use a combination of low dose irradiation,~          Alemtuzumab (Campath®), and sirolimus.~        4. Peripheral blood hematopoietic progenitor cell (PBPC) transplant: An unmanipulated~          peripheral blood stem cell collection from a filgrastim (G-CSF) stimulated HLA-matched~          donor should improve the chance of engraftment because of the high stem cell dose (5 x~          106/kg CD34+ cells) and the presence of donor lymphocytes. To reduce the risk of GVHD,~          patients will receive sirolimus before and after the transplant. The sirolimus will be~          tapered as necessary to minimize any graft versus host disease while still maintaining~          adequate chimerism.~   "
116817|NCT02038465|"~     The aim of the study is to assess the efficiency of SenseCam® in patients with schizophrenia~     by comparing two cognitive remediation methods of autobiographical memory.Patients and~     control participants will be invited to carry SenseCam® during 7 hours per day minimum and~     for 4 successive days. Each ending day when carry SenseCam®, they will be asked to go to the~     laboratory where 4 types of interventions will be successively done according to the~     randomization: 1) a simple visual retrospective procedure (SVR), 2) a visual retrospective~     procedure coupled with a specific cueing intervention (VR-SC), 3) a verbal retrospective~     (VbR) and 4) no intervention (control condition).The testing phase will take place 14 days~     after the last day of data collection and will consist in a cued recall task and a~     recognition task using the pictures obtained by the SenseCam® of the participants.According~     to our hypotheses, the vividness of memories will be higher in events subjected to the VR-SC~     procedure than in events subjected to the SVR and VbR procedures. This effect is expected for~     both patients with schizophrenia and controls participants. Since strategies to enrich memory~     details will be explicitly given to the patients when using the VR-SC procedure, we assume~     that patients will be able to normalize their scores.~   "
116818|NCT02038452|"~     Carpal Tunnel Syndrome (CTS) is a common condition in which a nerve (known as the median~     nerve) is squeezed where it passes through the wrist. It can cause pain or aching, tingling~     or numbness in the affected hand. It may disturb sleep, or affect ability to do day to day~     things.~      There have been several studies into the best treatment of patients with severe symptoms of~     CTS who are referred to a hospital for treatment. However, little is known about the best~     treatments for patients with mild to moderate symptoms who visit their GP but do not require~     hospital treatment.~      The study will investigate whether a steroid injection is clinically effective in reducing~     symptoms and improving function in the short term (6 weeks) compared to a night splint in~     people consulting with mild to moderate CTS in primary care.We will study the effects of~     these 2 treatments over 6 weeks and at 6 months. Subject to further funding, the Study will~     also look at whether these 6 weeks of treatment are effective 1 year and 2 years later.~      The study will take place in up to 50 GP practices and hospital clinics across the UK.~     Patients aged 18 and over who have been diagnosed with mild to moderate CTS which has been~     present for at least 6 weeks will be eligible for inclusion.~      The steroid is a drug called DepoMedrone. This drug is already widely used to treat CTS. In~     this study, one injection will be given. The splint is made of elastic and has an aluminium~     bar which sits on the palm of the hand. In this study, the splint will be worn at night for 6~     weeks. Each participant will receive either a single steroid injection or a splint, and will~     be asked to complete up to 5 questionnaires over 2 years.~   "
116858|NCT02037932|"~     The objective of the GELATIN registry is to prospectively evaluate intracranial aneurysm~     occlusion and retreatment rates as well as adverse event rates in patients undergoing~     balloon-assisted coiling using the MicroVention Scepter Occlusion Balloon Catheter and~     second-generation MicroVention hydrogel coils for treatment of previously treated or~     untreated ruptured and unruptured intracranial aneurysms.~   "
116819|NCT02038439|"~     Translation of new knowledge from research into evidence-informed health care is a shared~     obligation of the clinical and the scientific communities. Unfortunately, studies of quality~     of care continue to show that this goal is substantially unrealized. One main barrier is lack~     of quick and easy identification, appraisal and synthesis of current best evidence.~     Clinicians' information have 5 to 8 questions about individual patients per daily shift, but~     face a large volume of 3000 articles published every day, accessible in many scattered~     resources.~      To address theses problems, McMaster's Health Information Research Unit (Hamilton, Ontario,~     Canada) has developed and implemented McMaster Premium LiteratUre Service Federated Search~     (MPFS), an online search engine that provides a unique 1-stop search and organized access to~     current best evidence in daily practice. However additional barriers need to be overcome for~     clinicians to actually search and use this evidence in their practice. Theses include~     logistical barriers (time constraints, forgotten questions), as well as educational barriers~     (eg, lack of awareness of the architecture of evidence, limited searching skills, and lack~     of reference standards among peers for finding best evidence).~      This randomized trial seeks to test 3 innovative online interventions among clinicians~     registered to MPFS to overcome these barriers and increase the quantity and quality of~     searching for current best evidence to answer clinical questions. These interventions build~     on effective models for the teaching of clinical skills at the point of care, so that~     clinicians are facilitated in using the search engine as a clinical tool, and perceive~     evidence retrieval skills as true clinical skills.~   "
116820|NCT02038426|"~     Purpose:~        -  Assessment of ultrasound MASEI index in axial spondyloarthritis and in healthy subjects,~          athletes or not~        -  Comparison of the ultrasound semiology of enthesitis in the 3 populations~        -  Comparison of the MASEI scores in the 3 populations~   "
116821|NCT02038413|"~     Compared to conventional radiotherapy with photons (CRT), particle therapy (PT) has the~     potential to inflict maximum damage on tumors with minimum collateral damage to neighboring~     healthy tissue. Given that the cost of particle therapy (PT) is considerably higher than that~     of conventional radiotherapy (RT) with photons, it is necessary to establish whether these~     higher costs are worthwhile in light of the expected advantages. Thus, clear evidence of the~     situations in which PT outperforms conventional photon treatment is needed.~      In a previous ROCOCO study (lung stage I-IIIB) an inhomogeneous group of patients with regard~     to tumor stage and size was included1. Conformal radiotherapy and Intensity Modulated~     Radiotherapy were used in the comparison. In this study patients with smaller tumors are~     included (stage I). A stereotactic treatment schedule and more advanced treatment techniques,~     such as CyberKnife, RapidArc, IMRT and Tomotherapy, are eligible for these kind of lesions.~     As a result the comparison as demonstrated in our previous study maybe invalid. We propose to~     investigate to what extend proton and 12C-ion therapy decrease the amount of irradiated~     normal tissue compared to state of the art photon modalities in stage I lung cancer patients.~   "
116822|NCT02038400|"~     Otitis media are the consequence of bacterial infection. They are characterized by middle ear~     inflammations with a collection of fluid behind the eardrum. The effusion stagnates in the~     middle ear, can increase acute infection and induce tympanic membrane and inner ear damages.~     Delay in language learning can be observed in affected children as well as hearing problems~     e.g. constant hearing loss. The two main forms of chronic otitis are otitis media with~     effusion (OME) and atelectasis with or without retraction pockets.~      To date, insertion of tympanic ventilation tubes (tympanostomy) is the most effective~     treatment for otitis media with effusion that has failed to respond to conservative drug~     treatments; and for delaying the progression of serious atelectasis. When a first tube did~     not allow complete recovery, recurrence is then observed and insertion of new tube is needed.~     The repeated tube insertions increase risks linked to general anesthesia and increase rate of~     sequelae/complications, such as tympanic membrane perforation.~      Kinetube® is a CE-marked medical device, marketed in France and Europe since April 2002. This~     device improves the neuronal control mechanism of the pharyngotympanic (Eustachian) tube,~     regulating middle ear pressure. This could be an alternative for patients having recurrence~     and needing repeated tube insertion, as studies had shown that Kinetube® improved the opening~     of the Eustachian tube in patients with otitis media with effusion (OME) and atelectasis.~      These previous clinical studies have shown the feasibility of the use of Kinetube® in~     clinical practice. A larger clinical study with a high level of evidence must be performed to~     show therapeutic efficacy of the Kinetube® in chronic otitis compared to ventilation tube~     insertion.~   "
116823|NCT02038387|"~     Chronic hepatitis C virus (HCV) infection and nonalcoholic fatty liver disease (NAFLD) are~     characterized by a spectrum of pathological conditions ranging from an early stage of~     inflammation and fibrosis up to more advanced disease conditions, such as hepatocellular~     carcinoma. The prevalence of NAFLD is between 10 and 25% of the population, with large~     differences in age and ethnic groups, while it is well known that HCV infection is a major~     cause of chronic liver disease in Western countries.~      For both diseases the progression of liver damage is in close correlation with the lifestyle~     of patients (eg., nutrition, physical activity, ingestion of alcohol, etc.). In fact, it was~     shown that feeding imbalances may have implications in altering the normal immune functions~     of the subjects, suggesting that the metabolic and the immune systems are closely related to~     each other. Although it is well known the negative role of obesity on the progression of~     NAFLD and HCV liver diseases, the pathogenic mechanism underlying the alterations related to~     the immune response is not yet fully understood. Insulin resistance, altered lipid~     metabolism, lipid peroxidation, oxidative stress and mitochondrial alterations are pathogenic~     mechanisms that induce liver damage and its progression, both in NAFLD and in HCV infection.~      Recent studies suggest that the evolution of viral infections and chronic inflammation in~     NAFLD are deeply influenced by CD4+ T helper cells expressing IL-17 , defined as T helper 17~     (Th17) cells. Broadening the knowledge on the role of diet in the course of NAFLD and HCV~     infection in the activation of Th17 cells and in the alteration of some of their functions,~     will allow to shed light on the pathogenic mechanisms underlying the progression of~     immune-mediated diseases. Moreover, this investigation will allow to understand whether Th17~     cells may have a role in the diminished response to therapy in patients who have high~     cholesterol levels.~      If the results will confirm our hypothesis, this study will provide useful informations for~     the clinical management of patients with both steatosis and chronic HCV infection. The data~     obtained can also be used for the development of new therapeutic strategies directed to~     modulate the antiviral immune response.~      All patients will undergo clinical and instrumental assessment depending on the type of~     pathology. Patients will be required to follow a normocaloric low cholesterol diet for a~     period of 30 days.~      The prospective clinical study does not present any form of additional risk for the patients~     and will be conducted in accordance with the principles established by the Declaration of~     Helsinki and with the standards of Good Clinical Practice (GCP). The study does not require~     any additional costs.~   "
116859|NCT02037919|"~     Women who receive Nexplanon immediately post abortion will be significantly more likely to be~     using the device 6 months after the procedure than those assigned to receive the device 2-4~     weeks after the procedure.~   "
126979|NCT01905397|"~     The purpose of this study is to compare the rate of surgical site infection between~     traditional wound care and negative pressure wound therapy. Wounds will be assessed 4-5 days~     after surgery and at the first clinic visit after surgery.~   "
116824|NCT02038374|"~     Asthma is the most common chronic respiratory disorder in children. Despite significant~     advances in understanding of asthma, available therapies fail to alter the natural history~     and progression of the disease. Airway epithelial cells are continuously exposed to and~     injured by environmental irritants, such as viruses and pollutants, and as such are ideally~     situated to orchestrate airway function in response to these stimuli.~      Severe or difficult-to-treat asthma in children is a complicated disorder characterized by~     ongoing symptoms and persistent airway inflammation and oxidant stress despite corticosteroid~     treatment. Although severe asthma is likely a heterogeneous disorder, affected children~     similar clinical features, including gas trapping, bronchial hyperresponsiveness, and~     aeroallergen sensitization. However, the molecular and cellular pattern of inflammation in~     children with severe asthma are not uniform : some investigators have found increased~     eosinophils and TH2 derived cytokines, others have noted noneosinophilic patterns with~     neutrophil activation.~      Given the heterogeneity of the inflammatory response in children with severe asthma,~     additional methods to distinguish severe asthma are needed.~   "
116825|NCT02038361|"~     Acute leukemias are a heterogeneous group of malignancies characterized by the abnormal~     proliferation of a cell clone in the bone marrow, having as origin lymphocytic or myeloid~     lineage. The repertoire of mutations that determine the leukemic transformation, complex and~     variable depending on the tumor type and progression of the disease, combined in the same~     cell of balanced and unbalanced chromosomal aberrations, point mutations and epigenetic~     abnormalities.~      The project presented here is part of a comprehensive approach to diagnosis of hematologic~     malignancies of children. Using comparative genomic hybridization on microarray (or array-~     CGH) and transcriptome analysis by microarray, two innovative techniques for a comprehensive~     analysis of the genome and transcriptome , offer new perspectives identifying molecular~     defects . These techniques provide new elements in the identification of acute leukemia at~     diagnosis may identify new prognostic factors to optimize the care of patients.~      This project involves both the Department of Medical Genetics (Prof. N. LEVY ) regarding the~     identification of genomic abnormalities associated with childhood leukemia , the Laboratory~     of Hematology of the Hospital de la Timone ( Prof. Pierre Morange ) in terms of the~     phenotypic characterization of tumor cells, and the Onco - Hematology Pediatric Department~     (Prof. Michel Gerard ) which provides diagnosis, treatment , monitoring and the bone marrow~     of children with hematologic malignancies . The following project is mainly focused on the~     identification of genomic abnormalities (deletions and duplications) and abnormalities in~     gene expression to identify a genetic profile ensuring a better classification within the~     different groups risk .~      The project we propose is centered on the identification of genomic abnormalities , changing~     the number of copies of certain regions of the genome or determining loss of heterozygosity ,~     and the identification of changes in the level of gene expression by using two analytical~     techniques, comparative genomic hybridization on microarray (or array- CGH) and expression~     studies with microarrays . The data generated will , for the identification of  molecular~     signatures  , the classification of patients according to prognosis , variations in~     treatment response and survival.~      The originality of this project lies in the use of these new tools in the diagnosis of~     hematological malignancies in children. This pilot study will be conducted with commercial~     Affymetrix , will develop the chips ' processing' , dedicated , enriched probes corresponding~     to genes involved in leukemogenesis , with high discriminatory power in identifying these~     signatures.~      The data published in the specialized literature from the study of large series of patients~     show that microarrays provide important information for the diagnosis and therapeutic~     management of patients. It is for this reason that in the end we hope to integrate these~     analyzes in routine diagnosis to complement other analyzes ( phenotyping , identification of~     fusion genes and sequencing) in order to further characterize the abnormal cells leukemia and~     establish an  identity card of leukemia .~   "
116826|NCT02038348|"~     Melanoma incidence is increasing in most developed countries. At the metastatic stage, the~     prognosis is usually poor. Major advances have been obtained over the last 3 years with the~     development of therapies targeting the MAP kinases pathway.~      Vemurafenib (zelboraf®) is approved in France since 2012 as first treatment of metastatic~     melanoma carrying a B-RAF mutation.~      For growth, the tumor needs an adequate supply of nutrients to allow the synthesis of~     macromolecules and a contribution in carbon elements to ensure the production of energy. The~     nutrition demand is met through greater availability of nutrients via tumor angiogenesis and~     through increased intracellular penetration of nutrients via specific upregulation of~     transport systems and metabolic pathways.~      Scanner is the imaging method most commonly used for the evaluation of therapeutic response.~     Such a method gives a morphological indication but does not evaluate the metabolic response.~      With the development of functional imaging techniques and the advent of positron emission~     tomography (PET), it is now possible to obtain an assessment of the metabolic activity of~     tumors. The use of 18F-FDG to assess therapeutic responses to targeted therapies is fairly~     recent. The advantage of this approach is well documented for GIST and non-small cell lung~     cancer. In melanoma, the metabolic response to 18F-FDG is much faster than the response to~     TAP scanner.~      18F-FDG tracer that targets glucose metabolism, is the most sensitive functional imaging in~     melanoma, which has hindered the development of other tracers such as 18F-FDOPA and 18F-FLT.~     The 18F-FDG TEP can thus be used in the initial staging and follow-up of the disease, a~     situation in which it can replace the TAP scanner, additional brain imaging remaining~     necessary.~      The use of metabolic imaging to study the response to targeted therapies in melanoma has been~     the subject of only one publications. There was a trend toward improved progression-free~     survival in patients with high metabolic response at day J15.~      For melanoma, the diagnostic sensitivity of PET 18F-FDOPA is lower than that of 18F-FDG (64%~     versus 95%). In contrast, the 18F-FDOPA tracer has the advantage of allowing a brain~     assessment, which is critical in melanoma that gives frequent metastases in the central~     nervous system. There has never been any evaluation of the metabolic response to targeted~     therapies such as BRAF inhibitors PET with 18F-FDOPA.~      The investigators propose to conduct a monocentric prospective preliminary study to explore~     the potential usefulness of the metabolic PET imaging with 18F-FDOPA in the evaluation of~     metabolic response of B-RAF mutated metastatic melanoma treated with vemurafenib.~   "
116827|NCT02038335|"~     This study is being done to understand if using birth control causes changes in the immune~     cells within the reproductive tract of healthy women. Immune cells are important because they~     help prevent infections from starting and help fight infections that have started. Immune~     cells are also the type of cells that HIV (human immunodeficiency virus) infects so~     understanding more about them will help to better understand how to prevent the spread of~     HIV.~      Immune cells will be studied from the reproductive tract of women who want to start using one~     of the following contraceptives: Depo-Provera (DMPA), NET-EN, MPA/E2 (Cyclofem®), the~     levonorgestrel subdermal implant (Jadelle® ), the etonogestrel subdermal implant (Implanon®~     or Nexplanon® ) and the copper IUD.~   "
116828|NCT02038322|"~     This is a clinical study designed to validate the usability and safety of the~     over-the-counter (OTC) device by obtaining feedback in a home use environment regarding ease~     of use of The Stork™ Conception System and the instructions for use. In addition to~     usability, results for safety, including vaginal~   "
116829|NCT02038309|"~     Study of persistent platelet reactivity during acute coronary syndrome. Patients are included~     at admission to the hospital. Platelet aggregation is evaluated by platelet function testing~     after blood sampling during hospitalization. No changes in treatment is planned.~   "
116830|NCT02038296|"~     To evaluate local tumor control and survival rate after repeated transarterial~     chemoembolization(TACE) using three different protocols in hepatocellular carcinoma (HCC)~     patients.~   "
116839|NCT02038179|"~     We propose a novel intervention for reducing BP that could have a preferential impact in~     patients with hyperuricemia and gout. There is a great need for new anti-hypertensives,~     particularly among those with gout. The proposed study is novel in its plans to investigate~     the physiologic mechanisms through which urate contributes to vascular disease and by which~     ULT may contribute to BP reduction. Also innovative, we will: 1) determine to what extent the~     described benefit of lowering serum urate extends beyond the adolescent population previously~     studied into young adults, 2) test whether a urate-lowering approach will benefit individuals~     that do not yet meet the current definition of hyperuricemia and do not have gout, and 3)~     begin to explore potential mechanisms for the higher prevalence of hypertension among~     African-Americans. If successful, this work could translate to the standard of clinical care~     and to health care recommendations for the population as a whole.~   "
116831|NCT02038283|"~     Introduction: Colorectal cancer (CRC) is the second most common cancer among Chinese in Hong~     Kong and the second leading cause of cancer death in this population. Several screening~     strategies has been associated with improved survival and may affect patients' health-related~     quality of life (HRQOL). HRQOL impact should be used to adjust for survival in terms of~     quality adjusted life years (QALY) in the evaluation of cost-effectiveness of any~     intervention including screening.~      Objectives: to determine the HRQOL and health preference of patients with different stages of~     colorectal neoplasm, and to determine the most cost-effective CRC screening strategy for~     increasing QALYs.~      Design and Subjects: A longitudinal survey to collect data on HRQOL associated with~     colorectal neoplasm for Markov modeling on cost-effectiveness of CRC screening. A stratified~     sample of 420 patients with colorectal polyps and different stages of CRC will be recruited~     from colorectal clinics of Queen Mary Hospital for health preference and HRQOL assessment.~     The HRQOL over time will be measured at baseline, 6 and 12 months later. Health preference~     data will be integrated with cost and effectiveness data obtained from the literature to~     determine the cost-effectiveness of currently recommended CRC screening strategies by Markov~     modeling.~      Main outcome measures: The primary outcome measure is the SF-6D health preference value and~     QALYs. Secondary outcomes are the SF-12v2 and FACT-C scores. The outcomes will be compared~     between patients with different stages of colorectal neoplasm. Markov modeling study will~     estimate the expected QALYs gained and incremental cost-effectiveness ratio for each CRC~     screening strategy.~      Results: The study will provide information on HRQOL of patients with colorectal neoplasm to~     guide health services. The Markov Model will identify the most cost-effective CRC screening~     strategy for Hong Kong Chinese, which can inform policy makers and the public for the~     prevention of CRC of the population.~   "
116832|NCT02038270|"~     The Nexfin monitoring device relies on noninvasive pressure measurement using a finger-cuff~     manometer, combined with NIRS technology. The accuracy of the signal is dependent on the~     degree of vascular unloading, which takes an period before optimal unloading is reached. The~     evolution of the degree of inaccuracy caused by inclomplete unloading is quantified, and the~     absolute and relative inaccuracy of the nexfin as a function of the time is determined~     compared to the invasive blood pressure (IBP).~      Secondly, the accuracy of the Nexfin to predict the IBP is compared with the accuracy of~     noninvasive blood pressure to predict the IBP.~   "
116833|NCT02038257|"~     The purpose of this study is to:~        1. Compare two different techniques in the melanocyte keratinocyte transplant procedure:~          Use of carbon dioxide laser versus use of dermabrasion~        2. Compare two different dressings in the melanocyte keratinocyte transplant procedure:~          vaseline impregnated gauze versus collagen dressing~   "
116834|NCT02038244|"~     In this study, the effects of a 14-day inpatient treatment in an internal medicine ward for~     integrative medicine on pain, disability, quality of life, satisfaction with life,~     depression, and anxiety will be investigated. Furthermore the influence of potential process~     variables will be evaluated.~      Effects will be measured after completion of the program (2 weeks), and at 6 months follow up~     after start of the program.~   "
116835|NCT02038231|"~     The goal of study is to develop and test a parenting-focused version of mindfulness~     intervention (Parenting Mindfully) to reduce parent stress and prevent adolescent substance~     use and HIV risk behaviors (e.g., risky sex). The investigators hypothesize that Parenting~     Mindfully (PM) will decrease prevent adolescent substance use and HIV risk behaviors and~     intentions. Secondarily, PM will improve parenting, and decrease adolescent stress responses.~   "
116836|NCT02038218|"~     DM-CHOC-PEN is a polychlorinated pyridine cholesteryl carbonate that has demonstrated~     antineoplastic activities in patients with advanced cancers - melanoma, lung, breast and~     glioblastoma multiforme (GBM) involving the CNS during a Phase I study. These findings~     support the preclinical responses seen in mice bearing intracerebrally implanted human breast~     and GBM tumor xenografts. Toxicity was acceptable - hyperbilirubinemia (in patients with~     liver disease and/or liver metastasis). No hematological, renal, cardiovascular, behavioral~     or cognitive impairment/neurotoxicities were noted during the Phase I human trial or in~     previous pre-clinical studies.~      The drug is available for use as a soy bean oil/egg yolk lecithin/glycerin water emulsion;~     the latter continues to be chemically and biologically stable and safe.~      Patients with advanced lung, breast and melanoma cancers spread to the CNS and primary CNS~     malignancies will be eligible for enrollment and treatment, providing the required blood and~     other eligibility requirements are met. The trial will be 2-tiered - patients with liver~     involvement vs. non-liver involvement will be treated with different doses of the drug.~      The trial is open and patients are currently being enrolled and treated with the protocol.~   "
116837|NCT02038205|"~     A prospective cohort follow-up study design is undertaken. Both males and females with mild~     to moderate carpal tunnel syndrome will receive standard-of-care wrist splint for 6 weeks and~     undergo follow up studies for data collection. Controls will also be seen for a one time~     visit.~   "
116838|NCT02038192|"~     Hope is important for family/friends of persons with dementia residing in Long Term Care~     Facilities. Our research team has developed a program (Living with Hope) to increase hope and~     quality of life of family caregivers. The Living with Hope Program involves a) viewing the~     Living with Hope film which features caregivers of persons with dementia describing their~     hope and b) a hope activity entitled Stories of the Present. A new Living with Hope film~     entitled Connecting with Hope has been produced and will be used in this pilot study. The~     purpose of this pilot study is to evaluate the feasibility and acceptability of the Living~     With Hope Program and collect preliminary data on the effectiveness of the Living with Hope~     Program for family members of persons with dementia residing in Long Term Care.~      30 participants will be recruited from St. Joseph's Auxiliary hospital, the Alzheimer's~     Society of Alberta, and the Alberta Caregivers Association in Edmonton based on inclusion~     criteria. Participants will be randomly assigned to one of three groups: treatment (Watching~     a film on hope and Stories of the Present for one month); low dose group (Stories of the~     Present only); or usual care group. In all groups measures of hope, quality of life,~     self-efficacy and guild will be collected at visit 1, day 7, day 14 and one month in addition~     to demographic information. Participants in group 1 and 2 (treatment group) will be asked to~     describe what they were thinking about when doing the hope activities on day 7, 14 and one~     month using qualitative interviews. At one month all participants will be interviewed using~     open ended audio-taped questions to help evaluate the study procedures~   "
116840|NCT02038166|"~     The purpose of this study is to determine if acquired (partial) Cystic Fibrosis Transmembrane~     Conductance Regulator (CFTR) deficiency contributes substantially to the pathogenic~     mechanisms underlying Chronic Rhinosinusitis (CRS), creating a localized environment that~     impairs mucociliary clearance (MCC).~   "
116841|NCT02038153|"~     This phase I/II trial studies the side effects and best dose of lenalidomide and how well it~     works in treating older patients with acute myeloid leukemia who have undergone stem cell~     transplant. Biological therapies, such as lenalidomide, may stimulate the immune system in~     different ways and stop cancer cells from growing.~   "
116844|NCT02038114|"~     This study will test the impact of newly created and available symptom management patient~     education brochures on symptom burden [measured via the Edmonton Symptom Assessment System~     (ESAS)], health-related quality of life [measured by the European Organisation for Research~     and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30)], patient satisfaction~     with care [measured by the Princess Margaret Hospital Patient Satisfaction Questionnaire~     (PMH/PSQ-MD 29) and the European Organisation for Research and Treatment of Cancer Patient~     Satisfaction with Radiation or Chemotherapy (EORTC PatSat35 RT/CT)], self-efficacy, and~     knowledge at Sunnybrook Health Sciences Centre in Toronto, Canada. These brochures are~     designed for oncology patients in order to provide a response to symptom screening and are~     now a standard part of care. Symptom screening occurs at each visit as patients are required~     to fill out ESAS, that asks about their experience with the occurence and severity of~     symptoms. The intent of the patient brochures are to acknowledge the screen, validate the~     symptom and provide knowledge of self-management strategies for symptoms. The brochures also~     provide information to patients about when and how to seek further help from their oncology~     team. The hope is that patients will experience a useful response to their screen with all~     levels of symptoms-from 0-10 in severity~      It is hypothesized that the addition of patient education symptom management pamphlets on 7~     of the symptoms measured by ESAS (appetite, nausea and vomiting, depression, anxiety,~     fatigue, dyspnea and pain) will provide new and meaningful information which will build~     knowledge, validate the patient's experience of the symptom, lead to increased satisfaction~     with care, improved self efficacy in managing and accessing help for the symptom and~     therefore improved health related quality of life.~   "
116845|NCT02038101|"~     This study is an international, prospective, multi-centred, investigator blinded, randomized~     control trial of an educational and feedback-based intervention vs. usual care to study the~     proportion of inappropriate TTEs ordered by clinicians in ambulatory care.~      The American College of Cardiology collaborated with the American Society of Echocardiography~     to develop its Appropriate Use Criteria (AUC) for Echocardiography in 2007, and were updated~     in 2011.~      We created an innovative education and feedback-based intervention that we hypothesize will~     reduce the proportion of inappropriate TTEs ordered in clinical practice. Our objective is to~     prospectively study the following intervention in a multicentre, randomized control trial~     format to determine if this intervention will reduce inappropriate TTEs and the number of~     TTEs ordered in practice.~      The study will take place at multiple hospitals in Canada the United States. Participants~     include cardiologists and primary care providers (both general internal medicine and family~     practice) who provide ambulatory care.~      Once cardiologists and primary care physicians are recruited for the study, they will be~     randomized into one of two arms: 1) Intervention group, 2) Control group.~      A physician's TTE ordering information will be ascertained by review of the individual TTE~     order and by review of the patient's medical record. Trained research coordinators at each~     site will review the TTE order for indication and review the patient record to ascertain~     clinical circumstances regarding the TTE order. The individual research coordinator will~     review this information using the 2011 AUC and classify the TTE as Appropriate (A),~     Inappropriate (I) or Uncertain (U), and assign the TTE order the most appropriate indication~     number accordingly. Research Coordinators will be blinded to which physicians are in the~     intervention or control group.~      Research Coordinators at each site will be responsible for individual physicians' TTE order~     classifications but will be blinded to study group. Once monthly TTE orders are classified~     and collated, this information will be transmitted to the central research laboratory, where~     a research coordinator will collate all of the results and transmit monthly feedback reports~     to individual physicians. The control group will order TTEs as is their usual practice.~   "
116846|NCT02038088|"~     The purpose of this study is to determine whether the general anesthesia immunosuppressive~     could effect hepatitis B Virus replication~   "
116847|NCT02038075|"~     The primary purpose of this study is to compare the effectiveness of brief~     cognitive-behavioral therapy (B-CBT) for the treatment of suicidality, including suicidal~     ideation and attempts (regardless of Axis I or II diagnosis) among active duty military~     personnel. The standard null hypothesis will involve tests conducted comparing improvement~     following B-CBT (treatment duration of 12 weeks) to treatment as usual (TAU). The primary~     outcome comparisons will include both direct markers of suicidality (i.e. suicide, suicide~     attempts) and indirect markers including associated symptomatology (i.e. suicidal ideation,~     intent, anxiety, depression, hopelessness, substance abuse, and sleep disturbance), along~     with remission of psychiatric diagnoses. Secondary purposes include the prospective~     investigation of suicide risk factors and warning signs to explore these variables' ability~     to predict subsequent suicidal behavior following an index attempt.~   "
116848|NCT02038062|"~     Ischemic preconditioning is defined as protection from cell damage induced by prolonged~     ischemia by preceding cycles of short ischemia. Hence, ischemic preconditioning could reduce~     ischemic lesion during clamping a femoral artery for vascular surgery. In this prospective,~     randomized pilot study is investigated if clamping of the femoral artery leads to ischemia of~     the calf measurable by near-infrared spectroscopy. In addition to this, the effect of~     sevoflurane preconditioning on ischemia of the calf is measured.~   "
116849|NCT02038049|"~     The aim of this study is to determine if a monoclonal antibody VAY736 can reduce disease~     activity in relapsing-remitting multiple sclerosis (RRMS) as compared to placebo. The study~     will also provide the first safety and tolerability information for VAY736 in RRMS patients.~   "
116850|NCT02038036|"~     This trial will compare the efficacy and safety of ruxolitinib to Best Available Therapy~     (BAT) in patients with polycythemia vera (PV) who are hyroxyurea (HU) resistant or intolerant~     and do not have a palpable spleen.~   "
116851|NCT02038023|"~     To determine the percentage of women who achieve anemia correction after a single dose of~     1000mg of low molecular weight iron dextran(infed).~   "
116852|NCT02038010|"~     The purpose of this study is to see whether a combination of two different drugs -~     trastuzumab-MCC-DM1 (T-DM1) and BYL719 is safe, and if it might be effective in treating~     metastatic breast cancer. T-DM1 is a type of drug that contains an antibody (trastuzumab)~     linked to chemotherapy. The antibody in T-DM1 targets a marker on breast cancer cells called~     HER2, which allows the drug to go directly to the cancer cells. The use of T-DM1 in this~     study is considered standard treatment for the type of cancer in this study. Participants in~     this study have already been treated with trastuzumab and chemotherapy in the past, and their~     cancer has gotten worse in spite of those treatments. BYL719 is an oral drug (taken by mouth)~     that the researchers think may help T-DM1 to work better.~   "
116853|NCT02037997|"~     The purpose of this study is to evaluate and compare safety and effectiveness of Chemotherapy~     in Combination With Erlotinib,or Sequential Erlotinib for Treatment in Patients With EGFR -~     TKI Resistance of EGFR Mutations~   "
116854|NCT02037984|"~     This study is designed to assess the effect of different dose levels of pneumococcal~     polysaccharide and adjuvant on the safety and immunogenicity of V114 in healthy adults and~     infants.~   "
116855|NCT02037971|"~     The purpose of this study is to determine the effectiveness of exercise training on improving~     sleep in patients with systemic lupus erythematosus.~   "
116856|NCT02037958|"~     We hypothesise that the use of the LMA-Supreme provides greater ease of insertion and reduced~     haemodynamic variability during insertion compared to the tracheal tube, whilst still~     maintaining a patent airway to facilitate elective laparoscopic cholecystectomy in selected~     patients.~   "
116857|NCT02037945|"~     The main purpose of this study is to determine the distribution of 18F Fluorocholine~     (18F-FCH) in the brain which can help distinguishing radiation-induced scarring from tumor~     regrowth. In addition, the study will measure levels of 18F-FCH in the blood and (if~     applicable) in the brain lesion tissue that is removed as part of the planned brain surgery.~   "
116860|NCT02037906|"~     Research Problem: Shock wave lithotripsy (SWL) dramatically changed the management of renal~     and ureteral calculus disease. In vitro studies suggest that progressive increase in~     lithotripter energy output voltage could produce the best overall stone comminution in~     comparison with constant or deescalating energy output. However, it is possible that the~     beneficial impact of slow rate SWL on comminution of stones and stone free rates has masked~     any marginal benefits for energy output escalation. The Escalating SW method adds the benefit~     of less renal tissue injury.~      Research Significance:The present study will signifies and evaluates the stone free rates of~     three groups of patients with renal stones treated with different SWL energy outputs~     (Escalating, Constant and Reduction energy output).~      Research Objectives: The aim of this research project is to study the effect of dose~     adjustment strategies on success rate of Shock Wave Lithotripsy in the clinical setting and~     to optimize the conditions for successful Shock Wave Lithotripsy.~      Research Methodology: This clinical trial will be conducted at a tertiary care university~     hospital. 150 patients referred to the Shock wave lithotripsy unit will be evaluated for~     eligibility to be randomized into three groups (Dose Escalation, Dose reduction and constant~     dose). Parameter of the three groups will be compared to detect the treatment difference.~   "
116861|NCT02037893|"~     The primary objective is to compare the effect of treatment with a combination of ear~     solutions on the reduction of pain symptoms at 1 hour after dosing in children with acute~     otitis media.~   "
116862|NCT02037880|"~     The purpose of this study is to assess rates of decline in motor and cognitive functional~     measures, and to assess potential biomarkers, in order to identify potential outcome measure~     appropriate for use in therapeutic clinical trials.~   "
116863|NCT02037867|"~     Deaths due to advanced liver scarring (liver cirrhosis) continue to increase, and liver~     disease is now the 3rd leading cause of premature death in the United Kingdom. The majority~     of liver disease is lifestyle related (alcohol, obesity and associated type 2 diabetes,~     injecting drug use) and therefore reversible if caught at a precirrhosis stage. However,~     current liver function blood tests are poor inadequate, and subsequently a large burden of~     liver disease is currently missed.~      A variety of noninvasive liver biomarkers (blood and imaging tests) have been developed which~     identify liver disease accurately at earlier stages of scarring. The identification of liver~     disease in the community, where previous studies have discovered a large burden of previously~     unidentified but significant liver disease, is therefore a feasible place to develop new~     liver disease investigation pathways using these noninvasive markers.~      In collaboration with the Department of Health, Nottingham University Hospitals have~     commenced a pilot community liver disease pathway in two General Practices in Nottingham in~     February 2012. Patients with liver risk factors (hazardous alcohol use, obesity or type 2~     diabetes)are invited to take part in the pathway. Patients undergo a simple blood test~     (AST:ALT ratio and BARD score), with a high test result requiring referral for a liver~     stiffness scan (Fibroscan)which is performed in the community setting. High threshold scan~     values are reviewed by a consultant liver specialist in a community liver clinic. Preliminary~     findings show that the pathway accurately identifies patients with early liver scarring and~     previously unidentified significant liver disease. The participating General Practitioners~     have also noted a striking number of patients finally engaging in important lifestyle changes~     following pathway implementation. A second phase of the pilot pathway, in 2 Inner City~     General Practices with a total practice population of c.14,000 patients commenced in June~     2013.~      We have subsequently designed this cohort study, where pilot participants will be consented~     for follow up over a long period. We will assess future liver-related and cardiovascular~     events (including death), and perform qualitative patient interviews to assess the reasons~     for and persistence of lifestyle changes after liver disease investigation. We hypothesize~     that stratification of liver disease in the community will unearth a significant amount of~     previously undetected but significant chronic liver disease. Moreover, we will evaluate~     whether stratification of liver disease using these tests predicts future liver and~     cardiovascular disease and death, and whether stratification has an impact on patient's~     future lifestyle choices.~   "
116864|NCT02037854|"~     The purpose of this study is to assess whether food ingredient(s) affect glycemic and~     insulinemic responses.~   "
116865|NCT02037841|"~     Asthma is the most common chronic disease of childhood and is responsible for large portion~     of pediatric admissions to Canadian hospitals. There is evidence that clinical pathways allow~     for optimal delivery of care and may result in decreased length of stay, leading to important~     economic benefits. Weaning of asthma medications prescribed for asthma exacerbation is not~     standardized in the current model of care. Currently, weaning is performed by ward~     physicians; in a teaching hospital, this most often done by residents staff. Differences in~     practice between different physicians, delays in patient assessment and adjustment of~     doctor's orders, likely prolong the hospital stay for children admitted with asthma.~      This study's main objective is to determine the effect of a nursing-driven clinical pathway~     on children's length of stay when admitted to hospital with a diagnosis of acute asthma~     exacerbation. The pathway will allow nurses to wean a specific type of~     medication(β2-agonist), as compared to the current standard of care, which dictates that a~     physician writes an order to wean the medication. Number of administered β2-agonist~     treatments will be compared between both groups, as well as asthma-related health care~     utilization within two weeks of hospital discharge. Nursing, physician, and patients'~     satisfaction with the pathway will be evaluated, and a cost minimization analysis will be~     performed.~      This study has the potential to improve resource use efficiency, increase patient safety by~     avoiding administration of unnecessary medications, and ameliorate quality of care by~     standardizing the care of children admitted to the hospital with a diagnosis of acute asthma~     exacerbation. The results of the study will be disseminated across the Canadian Health Care~     System with the goal of improving outcomes of children admitted to hospitals with acute~     asthma exacerbations.~   "
116866|NCT02037828|"~     Chronic obstructive lung disease (COPD) is a worldwide leading and still increasing cause of~     chronic morbidity and mortality. The important issue of COPD is its delayed diagnosis.~     Previous studies have found that accelerated loss of forced expiratory volume in 1 second~     (FEV1.0) in an individual is considered an indicator of developing COPD. This functional~     predictive system, due to lower sensitivity, is very difficult to discover high-risk~     population and earlier stage of the disease. The inflammation occurs earlier than the lung~     function impairment. Therefore, early detection of the inflammation may theoretically predict~     the occurrence of COPD and thus may guide early intervention.~      Proteomics techniques and protein chip techniques provides us high throughput screening~     method to figure out characteristic inflammatory or metabolic markers of a diseases. It can~     be used for searching the biomarkers relating to lung function loss. EBC is collected from~     exhaled gas and is a good non-invasive method for exploring the pathologic process of the~     airways.~      Thus we designed this study to identify potential biomarkers associated with rapid lung~     function decline. This study is divided into two parts: 1) screening potential biomarkers~     between stable COPD and healthy individuals; 2) verifying significant biomarkers of first~     part in a community-based nested case-control population for 2 years.~   "
116876|NCT02037698|"~     The revascularization of chronic total occlusion of coronary arteries (CTO) is the most~     challenging procedure for the coronary intervention. For the initial period for CTO~     intervention, percutaneous coronary artery intervention (PCI) of CTO lesions are associated~     with low procedural success rates about 70%. Recently, the success rate of the recanalization~     of CTOs has been raised in several studies.~      Coronary CT angiography (CCTA) is an effective noninvasive diagnostic modality for detecting~     coronary artery disease. CCTA can visualize the complete anatomy of coronary arteries in~     contrast to conventional coronary angiography, reducing the deferral rates from CTO~     intervention. Assessment of characteristics of CTO lesions by pre-procedural CCTA could help~     to determine revascularization strategy and estimate the procedure time, leading to lower~     procedural complications. We suggest that success rates and clinical outcome of intervention~     of CTO lesion can be improved by pre-procedural CCTA.~   "
116867|NCT02037815|"~     Osmotherapy has been used as the medical treatment for brain edema and intracranial~     hypertension in critically brain injured patients. Measurement of serum osmolality during~     osmotherapy is of clinical importance to determine clinical efficacy, adjust dosage and avoid~     side effect. Serum osmolality is often measured in laboratory by cryoscopic technique as the~     reference method. However, in clinical setting, routine measurement of serum osmolality is~     not feasible at bedside, either in intensive care unit (ICU) or neurosurgical ward.~     Therefore, clinicians usually estimate serum osmolality by using equations derived from serum~     osmoles that can be measured by bedside blood gas analysis or routine laboratory chemical~     analysis, such as sodium, potassium, urea, and glucose. In present study, mannitol or~     hypertonic saline will be used in patients after craniotomy, and serum osmolality will be~     measured before and during drug infusion. Investigators hypothesize that the correlation of~     measured and calculated serum osmolality is better during infusion of hypertonic saline than~     mannitol.~   "
116868|NCT02037802|"~     pain control in pediatric renal transplant is a major concern. the main goal during~     anesthesia of renal transplant in pediatrics is to maintain hemodynamics in a range close to~     that of the adult donor. epidural analgesia is thought to be very effective in pain control.~     this study emphasises the ease of application of epidural catheter via the caudal route to~     the lower thoracic level; avoiding possible complications that may arise from lumbar or~     thoracic routes, and its effects on hemodynamics when using analgesic doses of local~     anesthetics and narcotics.~   "
116869|NCT02037789|"~     Low back pain (LBP) is one of the most common medical problems encountered in daily life; it~     is related to disability and work absence and accounts for high economical costs in Western~     societies.~      Low-back pain is a diverse group of mixed pain syndromes (neuropathic and nociceptive) with~     different molecular pathologies at different structural levels displaying similar clinical~     manifestations. Currently, there are limited biomarkers (mostly imaging) or clinical findings~     that can be used objectively to help the physician in precise anatomic diagnosis leading to~     the safest and most cost-effective treatment for the patient (reduction of direct and~     indirect costs and improvement of treatment efficacy).~      The main aim of this trial is to identify all omics biomarkers associated with~     susceptibility to chronic/persistent LBP and its different pathophysiology.~   "
116870|NCT02037776|"~     The purpose of this study is to assess the efficacy and safety of Rikkunshito compared to~     placebo in Japanese subjects with Functional Dyspepsia (FD).~   "
116871|NCT02037763|"~     This is a prospective observational cohort multinational clinical study. There are no~     biomarkers to help predict in which patients acute low back pain (LBP) will transform into~     chronic low back pain (CLBP). Human variability and different common comorbidities complicate~     the picture and make stratification of patients into correct subgroups difficult. However,~     drugs act by targeting specific molecular pathways and are therefore efficient only in a~     subgroup of patients sharing common molecular pathology and common genetics. Both CLBP and~     disc degeneration are known to be heritable. Little investigation has taken place for genetic~     variants in CLBP. The main aim of this trial is to identify omics biomarkers associated~     with the transition from acute (single episode of low back pain) to persistent/chronic LBP~     (pain lasting more than 12 weeks).~   "
116872|NCT02037750|"~     The purpose of this study is to conduct a randomized effectiveness trial to determine whether~     adding a preventive intervention at the transition from elementary to middle school is~     effective and cost effective in terms of ameliorating outcomes such as drug and tobacco use,~     participation in HIV- risking sexual behavior, delinquency, mental health problems, and~     school failure for young adolescents in foster care. The proposed LINKS intervention marries~     the goals of child welfare and educational systems. The aims are: a) to determine the~     effectiveness of the LINKS intervention on key behavioral health and school adjustment~     outcomes, b) to examine mechanisms of action; specifically the mediating effects of placement~     failure on outcomes, c) to examine the moderating role of fidelity on outcomes, and d) to~     examine cost effectiveness and cost avoidance of LINKS.~   "
116873|NCT02037737|"~     The purpose of this study is to assess Abatacept Intravenous (IV) effectiveness in patients~     with inadequate response to one or more conventional Disease Modifying Against Rheumatism~     (DMARDs) including Methotrexate in France, through the estimation of Abatacept retention rate~     over 2 years and reasons of discontinuation~   "
116874|NCT02037724|"~     The consequences of iron deficiency anemia in women are enormous, and especially in~     developing countries, as the condition adversely affects both their productive and~     reproductive capabilities. The study seeks to: 1) compare changes in iron status indicators~     among women receiving an iron-rich organic food supplement versus ferrous sulfate supplement,~     and 2) determine the suitable level of food supplement needed to prevent/reduce iron~     deficiency anemia among women in developing country settings.~      A double-blind, randomized, controlled, intervention trial will be implemented in women of~     childbearing age, 60 women with iron deficiency anemia and 60 women with iron deficiency.~     After screening potential subjects (up to 500 expected), approximately 30 will be recruited~     into each of four study groups; assuming 30% dropout rate, to detect an increase of 30% in~     ferritin as significant between the two time points at 80% power and alpha value of 0.05.~     Subjects who meet the inclusion criteria will be randomized into the four groups consisting~     of: 2 control groups (daily 60mg ferrous sulfate (FS-60) or daily 10mg ferrous sulfate~     (FS-10)), and 2 test groups (daily 60mg iron-rich supplement (IRS-60) or 10mg iron-rich~     supplement (IRS-10)). Subjects will take daily FS-60 and IRS-60 under supervision for 8 weeks~     while subjects taking FS-10 and IRS-10 will take the supplement under supervision for 12~     consecutive weeks.~   "
116875|NCT02037711|"~     Pain after laparoscopic surgery has been associated with surgical manipulations, including~     intraperitoneal insufflation of carbon dioxide (CO2), resulting in peritoneal stretching,~     diaphragmatic irritation, changes in intra-abdominal pH, and retention of the insufflated gas~     in the abdominal cavity after surgery. These effects may result in the irritation of~     peritoneal nerves causing visceral pain, as commonly reported after laparoscopic procedures~     in pediatrics.~      The study hypothesis is that Intraperitoneal local anesthetic (levobupivacaine) instillation~     can provide pain relief after laparoscopic surgery, but local anesthetic distribution may not~     always be uniform throughout the peritoneal surface. Many methods were tried for~     intraperitoneal application of local anesthetics in laparoscopic surgery such as local~     anesthetic (LA) instillation and LA nebulization.~      -But these methods are not widely used in pediatrics upon our knowledge~   "
116877|NCT02037685|"~     Statins are cholesterol lowering medications that reduce the risk of cardiovascular events.~     However adherence to these medications has been found to be lower among minorities, a group~     particularly vulnerable for heart disease.~      The purpose of this study is to compare the efficacy of a phone based behavioral intervention~     to mailed educational materials regarding how to control cholesterol and other risk factors.~     We hypothesized that the behavioral intervention will improve adherence to statins by 15%.~   "
116878|NCT02037672|"~     The purpose of this study was to determine whether combined treatment with~     phosphodiesterase-4 (PDE-4) inhibitor roflumilast and metformin is more effective than~     metformin as monotherapy in the treatment of obese women with polycystic ovary syndrome~     (PCOS) who had been previously poor responders regarding weight reduction on metformin~     monotherapy. The investigators anticipated greater changes in body weight in patients on~     combined treatment than in those on monotherapy with metformin.~   "
116879|NCT02037659|"~     The purpose of having a database is to collect data related to endoscopic ultrasound~     procedures performed by Indiana University EUS physicians; specifically, for the treatment of~     gastric variceal bleeding This data will be used for research purposes only to determine the~     clinical impact of endoscopic ultrasound treatment of gastric variceal bleeding. The~     physicians will also be able to better understand the patient's condition and disease process~     that may lead to improved standard of care and improved patient management.~   "
116880|NCT02037646|"~     The main aim of this study is to determine whether there is a difference in time to diagnosis~     of advanced colorectal neoplasms using quantitative Fecal Immunochemical Tests (FIT) to~     prioritize referral for colonoscopy (intervention) compared to usual care (qualitative FIT~     and appointment-based referral).~   "
116881|NCT02037633|"~     The purpose of this study is to compare two analgesic methods performed preoperatively to~     assist positioning patients for performance of spinal anesthesia, namely fascia iliaca~     blockade and intravenous fentanyl.~   "
116882|NCT02037620|"~     We propose to demonstrate that epidural stimulation (ES) can be used to recover significant~     levels of autonomic control of cardiovascular and respiratory function as well as the ability~     to voluntarily control leg movements below the injury level. This intervention would provide~     an immediate therapeutic alternative to individuals who now have no recourse for treatment.~   "
116883|NCT02037607|"~     The purpose of this study is to determine how frequently children undergoing elective~     neurosurgical procedures develop blood clots in the deep veins of the legs while~     hospitalized. The information gained from this study will help us determine when children~     children need to receive therapy to help prevent this type of blood clot from forming.~   "
116884|NCT02037594|"~     This study identifies social and behavioral factors likely to influence PrEP acceptability~     and adherence among men who have sex with men (MSM), and collaborates with a community health~     center to evaluate a two-stage intervention to improve PrEP decision-making, as well as~     persistence and adherence for those who chose to take PrEP.~   "
116885|NCT02037581|"~     Improvement of clinical long-term outcome through the implementation of early detection and~     intervention within a specialized network of integrated care (ACT and hometreatment) for~     adolescents and young adults with a first episode of psychosis between 12 and 29 years.~   "
116886|NCT02037568|"~     PURPOSE: As this is a randomized controlled trial, all subjects receiving stress management~     psychoeducation will be expected to obtain a new set of coping skills that will allow them to~     better deal with the stressors of caregiving for an allogeneic HSCT patient. It is expected~     that improving caregiver status will improve patient quality of life.~   "
116887|NCT02037555|"~     This is a prospective, multicenter, randomized, double-blind, placebo-controlled study. The~     purpose of this study is to determine the safety and effectiveness of human-derived~     antithrombin III (AT-III [Human]) supplementation prior to high-risk, non-emergency, cardiac~     surgery with cardiopulmonary bypass (CPB). A total of 404 adult subjects undergoing CPB who~     meet the study eligibility criteria will be randomized to receive either AT-III (Human) or~     placebo.~   "
116888|NCT02037542|"~     The purpose of this study is to test the hypothesis that an intervention of lifestyle~     modification will positively impact women with breast cancer who are overweight and/or obese.~     To that end, our primary endpoint is to examine the effects of a practical lifestyle~     intervention that can be implemented by overweight or obese women (BMI greater or equal to~     25) with early stage breast cancer (I-III) on outcomes such as body weight and change in BMI~     over the course of the study.~   "
116889|NCT02037529|"~     This randomized phase III trial studies how well eribulin mesylate or paclitaxel work as~     first- or second-line therapy in treating patients with stage IIIC-IV breast cancer that has~     come back. Drugs used in chemotherapy, such as eribulin mesylate and paclitaxel, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading.~   "
116890|NCT02037516|"~     The purpose of this study is to determine if residual weakness after weight loss surgery~     leads to an increased risk of respiratory complications in the postoperative period.~   "
116891|NCT02037503|"~     Suicide attempts are a serious concern worldwide. Currently, existing drugs take about three~     weeks to show effect on suicidal thoughts and drives. Recent evidence suggests that~     intravenous Ketamine exerts a rapid effect in suicidal patients, even after a single~     injection. We aim to examine whether oral Ketamine is a safe and effective treatment in~     suicidal patients. Following a suicide attempt, patients will be randomized into a group that~     will be given Ketamine for 21 days and one that will receive placebo, and assessed using~     questionnaires and brain scans. We expect early improvements in suicide scales in the~     Ketamine group.~   "
116892|NCT02037490|"~     This is a randomized controlled pilot trial of a peer-based, social media intervention to~     prevent obesity in infants.~   "
116893|NCT02037477|"~     The purpose of this study is to investigate the acid-inhibitory effect of multiple oral doses~     of Vonoprazan (TAK-438) and the relative effect of vonoprazan versus two controls~     (esomeprazole and rabeprazole sodium) in healthy Japanese adult male participants with the~     CYP2C19 extensive metabolizer (EM) genotype.~   "
116894|NCT02037464|"~     The purpose of this study is to determine the chemopreventive properties of capsaicin, the~     active compound in chili peppers, in prostate cancer patients enrolled in the active~     surveillance program or patients scheduled to undergo radical prostatectomy.~   "
116895|NCT02037451|"~     Parkinson's disease (PD) is a progressive degenerative disease of central nervous systems~     deficit. The clinical symptoms of Parkinson's disease include the following motor tasks:~     difficult in initiating movement, performing rhythmic movement or serial movement, the~     ability of learning motor movement is also affected. The primary treatment for Parkinson's~     disease is medical treatment; surgery is used if in need. Rehabilitation such as physical~     therapy, which aims to improve patient's quality of life and functions, is a non-invasive~     treatment and value for PD patients. Auditory cue is a technique that widely applied on~     training patients with Parkinson's disease, and some researches revealed that auditory cueing~     could improve motor performance. However, the mechanism under this treatment technique is~     still unknown.~      This study is to investigate the effect of auditory cueing on rhythmic finger movement in~     patients with Parkinson's disease. To investigate the mechanism under auditory cueing,~     neurophysiological data such as motor cortex excitability and blood flow in cortical cortex~     will be obtained by using Transcranial magnetic stimulation (TMS) and near infrared~     spectroscopy (NIRS).~   "
116896|NCT02037438|"~     Sustainable Methods, Algorithms, and Research Tools for Delivering Optimal Care Study (SMART~     DOCS) will develop and evaluate a new approach (patient-centered outcomes and~     coordinated-care management [PCCM]) for the diagnosis and treatment of sleep disorders.~     Specialized and pertinent information and resources regarding sleep disorder management will~     be developed and made available through an online portal, allowing patients to make informed~     health care decisions, and providers to assist patients in achieving what they feel are the~     most important goals regarding their care. Half of participants will be randomized into the~     conventional diagnosis and treatment (CONV) arm and the other half into the patient-centered~     outcomes and coordinated-care management (PCCM) arm. Validated objective and subjective~     assessment measures will be administered at intervals throughout a 13 month participation~     period in both the CONV and PCCM arms to determine whether the new PCCM approach for sleep~     medicine results in increased patient satisfaction, quality of care, and improved health~     outcomes. Qualifying participant will be 18 years of age or older, presenting with a new~     sleep disorder. Patients will be enrolled for 13 months and will receive no monetary~     compensation.~   "
116897|NCT02037425|"~     To obtain a patient specific understanding of response to treatment with onabotulinumtoxinA~     by collecting and correlating pre and post treatment subject specific history, clinical~     outcomes, and histological changes.~   "
116898|NCT02037412|"~     The investigators hypothesized that ticagrelor may enhance endothelial healing after DES~     implantation by increasing adenosine concentrations by the inhibition of adenosine uptake~     into erythrocytes, compared to clopidogrel. Thus, the investigators will evaluate the extent~     of endothelialization (stent strut coverage) and neointimal hyperplasia (neointimal~     thickness) 3 months after DES implantation by optical coherence tomography (OCT)~   "
116899|NCT02037399|"~     Besides major ESD-related complications, minor adverse events after ESD are also commonly~     noticed. Pain is one of minor ESD-related complications. . The causes of pain associated with~     ESD or gastric polypectomy are thought to be associated with transmural burn or transmural~     air leak. How control localized pain for patients who suffered from pain after ESD is~     appearing as new medical interests. There are few studies about management strategy for pain~     after ESD. Glucocorticoids are used to reduce inflammation and tissue damage in various~     clinical settings including inflammatory disease, rheumatic disease, and so on. The efficacy~     of glucocorticoids for reducing pain after surgery has recently been investigated.~     Glucocorticoids are thought to locally inhibit collagen deposition and fibrosis and finally~     reduce scar-tissue formation. Especially systemic steroids are easy to achieve a continuous~     effect through stable serum concentrations. If pain was partially associated with acute~     inflammation, we assumed intravenous dexamethasone could be helpful to relieve pain after ESD~     based on previous studies. we aimed to assess the efficacy of single dose postoperative~     intravenous dexamethasone for pain relief after ESD.~   "
116900|NCT02037386|"~     Intervention for coronary bifurcation lesion is about 10~20% of entire percutaneous coronary~     intervention (PCI). Bifurcation lesion is difficult to be treated and prognosis of PCI at~     bifurcation lesion has been poorer compared to that at non-bifurcation lesion. Furthermore,~     occlusion of side branch frequently occurred during PCI. Several techniques to prevent~     occlusion of side branch have been developed, but outcomes are not to be satisfied. H-side~     branch stent is developed to treat coronary side branch lesion and composed of proximal,~     connecting and distal parts. In vivo study performed in pigs showed effective H-side branch~     stent. This study is to confirm safety and efficacy of H-side branch stent for treatment of~     coronary side branch lesion.~   "
116901|NCT02037373|"~     Post-Marketing Requirement study to evaluate the safety of octaplas™ versus plasma in~     patients undergoing orthotopic liver transplantation (OLT). The primary objective is to~     assess the incidence of hyperfibrinolysis in patients undergoing (OLT) receiving octaplas™~     versus regular plasma (e.g., fresh frozen plasma and other FDA and AABB approved plasma~     products).~   "
116902|NCT02037360|"~     The purpose of this study is to assess the effectiveness of a Mobile Mindfulness Training~     smartphone application on smoking cessation in smokers ages 18 to 65 years.~   "
116903|NCT02037347|"~     To test the ability of palifermin (a recombinant human keratinocyte growth factor) to~     decrease mucocutaneous injury and to promote epithelial repair in Toxic Epidermal Necrolysis~     and Stevens-Johnson Syndrome-Toxic Epidermal Necrolysis Overlap, diseases in which there is~     extensive sloughing of the skin and mucosa, including that of the eyes, gastrointestinal~     tract, respiratory and genitourinary systems.~   "
116904|NCT02037334|"~     Quantitative information on the biomechanical properties of the ecto-cervix in mid-pregnancy~     will be compared between women with term vs. preterm delivery. We aim to demonstrate that~     biomechanical data (ASP and CCI) might complement morphological data (CL) to improve~     prediction of preterm delivery. It is expected that women with preterm delivery will show~     stronger weakening of cervical tissue. Aspiration (ASP) and cervical CCI (cervical~     consistency index) measurements are performed at mid-pregnancy: detection at this time point~     is useful for therapy and biomechanical modifications are already significant so to enable~     differentiation by biomechanical measurements (ASP and CCI).~   "
117771|NCT02025985|"~     The primary trial objective is to determine the efficacy of KPT-330 (selinexor) in patients~     with advanced or metastatic gynaecological cancers by disease control rate (complete response~     (CR) or partial response (PR) or stable disease (SD) for at least 12 weeks, assessed~     according to RECIST 1.1 criteria).~   "
116905|NCT02037321|"~     Vegetarian diets have been associated with a reduced risk of preventable diseases such as~     type 2 diabetes and cardiovascular disease. These effects may be mediated through direct or~     indirect pathways. Although the high intakes of nuts, legumes, dietary fibre, whole grains,~     and unsaturated plant oils have each individually been associated with lower risk of type 2~     diabetes and cardiovascular disease, so too has the displacement of red meats, processed~     meats, and saturated animal fats. One of the most important considerations in moving from~     animal-based diets to more plant-based diets is the replacement of animal proteins (e.g.~     meat, fish, dairy, eggs) with vegetable proteins (e.g. legumes, nuts, and seeds). It is~     unclear whether this particular replacement alone results in advantages for metabolic and~     cardiovascular health. To improve evidence-based guidance for dietary guidelines and health~     claims development, we propose to conduct a series of systematic reviews and meta-analyses of~     the effect of plant-based protein in exchange for animal protein on blood lipids, glycemic~     control, blood pressure, body weight, uric acid, markers of non-alcoholic fatty liver disease~     (NAFLD), and kidney function and injury. The systematic review process allows the combining~     of the results from many small studies in order to arrive at a pooled estimate, similar to a~     weighted average, of the true effect. The investigators will be able to explore whether the~     effects of replacing animal-based protein for plant-based protein hold true across different~     sexes, age groups, and background disease states and whether the effect depends on the~     protein source, dose, or background diet. The findings of this proposed knowledge synthesis~     will help improve the health of Canadians through informing recommendations for the general~     public, as well as those at risk of heart disease and diabetes.~   "
116906|NCT02037308|"~     The Glu298Asp polymorphism has been linked to increased risk of cardiovascular events,~     proposed to be due to reduced nitric oxide production by eNOS reported in some but not all~     studies. We hypothesise that beetroot-enriched bread interacts with the Glu298Asp~     polymorphism of the eNOS gene to lower blood pressure and increase plasma nitrate/nitrite,~     particularly in carriers of the T allele, which have been associated with lower eNOS activity~     and increased risk of hypertension.~   "
116907|NCT02037295|"~     The prevalence of obesity has risen to epidemic proportions in the world, resulting from both~     excessive energy intake and low levels of energy expenditure. The effect of nutrient~     absorption on energy balance, that is, the relative amount of nutrients consumed vs. the~     amount excreted in stool, has been reported only in small studies in which energy waste in~     feces and urine between lean and obese individuals was not found to be different. New studies~     have shown that bacteria in the gut may play an important role in calorie absorption. We have~     recently shown that leaner individuals absorbed more calories when overfed compared to when~     they were given a diet with just enough calories to maintain their own weight. Our studies~     have also found that overfeeding also changes the kinds of bacteria found in the gut. In lean~     individuals, these changes in gut bacterial communities with overfeeding were associated with~     changes in how many calories were absorbed. Our results are similar to those seen in other~     studies in animals and humans that suggest a role for gut bacteria in weight gain and~     obesity. To try to better understand the role of gut bacteria in absorbing food, we propose~     to investigate 1) whether energy loss (as measured in stool and urine) changes following~     over- and underfeeding relative to body size and 2) whether changes in the gut bacteria,~     induced by an antibiotic medication, affect nutrient absorption and glucose tolerance. We~     plan to study 24 healthy non-smoking volunteers age 18 45 years old, not taking any~     medications (including medications for weight loss, antibiotics or probiotics) for the~     examination. All participants will be admitted to the Clinical Research Unit for 31 days.~     During their stay, subjects will be fed a weight maintaining diet for 3 days, followed by two~     experimental diets (150% and 50% of weight maintaining calories) in a random order. After~     this, volunteers will be randomly assigned to one of two groups: group 1 will take oral~     antibiotic medication; group 2 will receive pills that look the same but will not contain any~     active medication (placebos). Feces (stool) will be collected throughout the study.~     Additionally, twenty four-hour urine collections will take place each day of the experimental~     diet period and when stool is collected on the antibiotics. The energy content of these waste~     products as well as that of the diet (using duplicate plate analysis) will be measured by~     bomb calorimetry. Bacterial components in feces will be extracted by repeated fractional~     centrifugation to obtain bacterial mass and by using 16S rDNA-based oligonucleotide probes to~     obtain data on gut bacteria. Primary results will examine how many calories remain in stool~     during relative over- and underfeeding and whether changes in gut bacteria, induced by an~     antibiotic medication, affect nutrient absorption and glucose tolerance.~   "
116908|NCT02037282|"~     Despite currently available antivirals, influenza causes significant morbidity and mortality,~     with 226,000 excess hospitalizations and 30,000-50,000 deaths each year in the United States~     alone, and more therapies are needed in the armamentarium of anti-influenza medications~     including humoral immunity-based agents.~      This study will evaluate the pharmacokinetics of an anti-influenza hyperimmune intravenous~     immunoglobulin. Beginning with a low dose, subjects will receive anti-influenza intravenous~     immunoglobulin (FLU-IVIG) and evaluated on Study Days 0, 3, 7, 14, and 28. The safety and~     tolerability is evaluated using symptoms, clinical laboratory tests, and pharmacokinetics.~     Utilizing serum antibody responses as determined by hemagglutination inhibition (HAI) assays,~     the dose will be escalated as immunogenicity is established....~   "
116909|NCT02037269|"~     This study is a prospective, cross-sectional observational single centre study to assess the~     feasibility of intra-operative Cerenkov Luminescence Imaging (CLI) of breast cancer wide~     local excision (WLE) specimens and dissected lymph nodes. The samples will be imaged using~     the LightPathTM Imaging System. The LightPathTM Imaging System which consists of a~     light-tight box on which are mounted an ultra-sensitive lens and radiation-shielded camera.~     This study will measure the correlation between margin status of the WLE specimen and the~     metastatic status of dissected lymph nodes as determined by the LightPathTM Imaging System~     and by histopathology. This is a pilot study to assess feasibility before proceeding to a~     pivotal study to evaluate the benefits of the LightPathTM Imaging System in clinical~     practice.~   "
116910|NCT02037256|"~     This clinical trial studies peripheral blood hemapoietic stem cell mobilization with the~     combination of bortezomib and G-CSF (filgrastim) in multiple myeloma and non-Hodgkin lymphoma~     patients. Giving chemotherapy before a peripheral stem cell transplant stops the growth of~     cancer cells by stopping them from dividing or killing them. After treatment, stem cells are~     collected from the patient's blood and stored. The stem cells are then returned to the~     patient to replace the blood-forming cells that were destroyed by the chemotherapy.~   "
116911|NCT02037243|"~     An estimated 2.2 million children under the age of 5 years die from diarrheal disease each~     year. Most of the burden of diarrheal disease is thought to be preventable with improvements~     in sanitation, water quality, and hygiene. Large scale interventions promoting these~     behaviours have either not been rigorously tested or have not produced sufficient change to~     warrant being rolled out at scale.~      Research into the determinants of hand washing behaviour has identified disgust and shame as~     key motivators. Evidence supports the theory that disgust is a natural behavioural reaction~     to objects carrying disease risk, thus it may act as a key motivator for other health related~     behaviours such as water treatment. Whether this knowledge can be harnessed to increase the~     efficacy of hand washing and safe water campaigns in Bangladesh or elsewhere has yet to be~     rigorously tested.~      The investigators will develop an intervention that utilizes disgust and shame eliciting~     messages to promote hand washing with soap and point of use water treatment in low income~     housing compounds of urban Dhaka. The investigators will test the efficacy of this~     intervention against a more traditional public health intervention based on increasing~     knowledge of health risks and germ transmission using a randomized controlled trial. The~     study sample will be broken into the following four arms.~        1. Standard Public Health Intervention with Water Treatment~        2. Standard Public Health Intervention with Water Treatment & Hand Washing~        3. Disgust and Shame Based Intervention with Water Treatment~        4. Disgust and Shame Based Intervention with Water Treatment & Hand~      This design will allow us to compare outcomes for hand washing and water treatment between~     both standard public health interventions and disgust and shame based interventions as well~     as test the overall efficacy of the program comparing with the control. Data will be~     collected from all compounds at baseline, three month midline and at the six month endline~     giving us the practical and analytical benefits of a longitudinal dataset.~      Compounds will participate in interactive, educational safe water and/or hygiene promotion~     meetings. For the Disgust and Shame group, these meetings will emphasize disgust and shame~     related to unsafe water and/or hygiene practices, whereas the Standard group's meetings will~     resemble a more typical public health intervention explaining the risks and methods of~     contamination.~      At the first meeting, compounds will receive a one month free trial of the latest compound~     based chlorine dispenser model to treat their drinking water. A randomly selected half will~     also receive a one month free trial of the latest compound based handwashing station. At the~     end of the month, there will be a sales meeting in which the investigators will measure~     compound members' willingness to pay for the trialled products by giving them the opportunity~     purchase and keep the hardware in a Becker-DeGroot-Marschek (BDM) style auction.~      In assessing the impact of the interventions, the investigators are primarily interested in~     whether the prevalences of safe water and hygiene behaviours differ by treatment arm and over~     time. The best measurements for approximating behaviour prevalence are physical observations~     (presence of residual chlorine, hand cleanliness inspections), structured observation of~     behaviour, rapid physical observations (physical state of hardware/drinking water),~     self-report of water treatment and hand washing behaviour and willingness to pay for~     necessary products. The investigators will also attempt to measure and track changes in~     personal determinants of behaviour such as feelings of disgust and shame related to hand~     washing and water treatment behaviours.~   "
116912|NCT02037230|"~     The investigators' long-term goal is to improve the survival of patients with pancreatic~     cancer by enhancing the efficacy of gemcitabine-radiation by adding the Wee1 inhibitor~     MK-1775.~   "
116933|NCT02036957|"~     Capecitabine is a drug that produces dermatologic toxicity frequently (palmoplantar~     erythrodysesthesia, rash , alopecia , erythema , dryness, pruritus, hyperpigmentation , rash,~     peeling , dermatitis , abnormal pigmentation, and less often blistering, skin ulcers ,~     photosensitivity reactions, swelling of the face and purple) . The impact in patients'~     quality of life is great, so We had decided to conduct a randomized clinical trial to~     evaluate the effectiveness Mary D' uol balm preventing dermatologic toxicity in patient~     treated with capecitabine .~      Design: Randomized clinical trial phase II, in parallel and double-blind groups~      Target population : Patients with colon cancer stage II or III ( Dukes' C ) , who will~     initiate treatment with capecitabine monotherapy.~      Inclusion criteria: Over 18 years, II or III colon (Dukes' C) colon cancer, primary~     diagnosis, capecitabine monotherapy, sign the informed consent.~      Primary endpoint: Dermatologic toxicity (yes / no) Statistical analysis: The primary endpoint~     (percentage of patients that develop dermalogic toxocity in both groups) will be analyzed by~     a logistics regression model~   "
116913|NCT02037217|"~     A feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial~     MRI-guided focused ultrasound (MRgFUS) treatment of patients with medication-refractory~     movement disorders, namely Essential Tremor (ET).~      This study is designed as a prospective, single site, single arm, nonrandomized study.~     Assessments will be made before and three months after MRgFUS for clinical symptom relief,~     quality of life (QoL) improvements, and safety of MRgFUS in the treatment of ET. Similarly,~     QoL measures will be obtained using Quality of Life in Essential Tremor (QUEST)~     questionnaire. Relative Safety will be evaluated using a common description of Significant~     Clinical Complications for patients treated in this study. This study will be performed on~     the 3T MR scanners.~      The ExAblate system is a medical device that involves a focused ultrasound system and an MRI~     scanner. ExAblate delivers a pulse of focused ultrasound energy, or sonication, to the~     targeted tissue. In this particular study the targeted tissue is a unilateral thermal lesion~     created in the ventralis intermedius nucleus of the thalamus.~      The treatment begins with a series of standard diagnostic MR images to identify the location~     and shape of tumor to be treated. The ExAblate computer uses the physician's designation of~     the target volume to plan the best way to cover the target volume with small spots called~     sonications. These treatment spots are cylinder shaped. Their size depends on sonication~     power and duration. During the treatment, a specific MR scan, which can be processed to~     identify changes in tissue temperature, provides a thermal map of the treatment volume to~     confirm the therapeutic effect. The thermal map is used to monitor the treatment in progress,~     and confirm that the ablation is proceeding according to plan, thus closing the therapy loop.~      The ExAblate transcranial operates a helmet-shaped transducer (currently utilizing~     1000-element phased array transducer) positioned above the subject head. The ExAblate~     transcranial system also includes means to immobilize the subject head, cool the interface~     water, and software for CT analysis and phase correction computation.~      The ExAblate transcranial system is an experimental device and is being investigated in this~     study.~   "
116914|NCT02037204|"~     Articular cartilage defects in the knee have a poor intrinsic healing capacity and may lead~     to functional disability and osteoarthritis. Cartilage cell therapy using autologous~     chondrocyte implantation (ACI) has been established as the first advanced treatment therapy~     medicinal product. Although this technique has achieved good mid-term results, it is a costly~     and extensive two-stage procedure which is limited by the number of chondrocytes obtained by~     biopsy and the dedifferentiation resulting from the expansion phase. Therefore, there is a~     need for improvement. A new cartilage repair technique should aim at decreasing surgical~     trauma, lowering complexity, improving logistics and cost-effectiveness while retaining or~     improving clinical outcome. Direct contact between mesenchymal stromal cells (MSCs) and~     dedifferentiated articular chondrocytes in vitro showed improvement of the chondrogenic~     phenotype of dedifferentiated articular chondrocytes. In addition, preserving the~     pericellular matrix of chondrocytes improves cartilage formation. These chondrons~     (chondrocytes with their pericellular matrix) have shown improved cartilage formation when~     combined with allogeneic MSCs in extensive preclinical studies. The cells are mixed with~     fibrin cell carrier and applied to the cartilage lesion within one surgical procedure. This~     will reduce patient morbidity and improve patient care through immediate transplantation of a~     potent cell-based cartilage product. This is a phase I/II prospective monocenter study to~     evaluate the safety and feasibility of the IMPACT for treatment of focal articular cartilage~     lesions of the knee.~   "
116915|NCT02037191|"~     Alopecia areata (AA) is an auto immune disorder. Treatment of severe types remains difficult~     with a rate of hair regrowth which is lower than 10%. This RCT will assess the safety and~     efficacy of methotrexate alone or associated with low doses of prednisone versus placebo in~     the treatment of severe types of AA.~   "
116916|NCT02037178|"~     The main objective of this study is to evaluate the inter-observer concordance when measuring~     the maximum value of the external antero-posterior diameter of the sub-renal aorta (both~     cross-sectional and longitudinal ultrasound views are measured). The first measure is made by~     a general practitioner in private practice; second reading are made by an expert in vascular~     medicine.~   "
116917|NCT02037165|"~     -  To investigate the influence of different doses of BI 1026706 on the primary endpoint~          (PtP-amplitude LEP in UV skin) compared to placebo.~        -  The comparison of both doses of BI 1026706 to celecoxib in the UVB treatment.~        -  Comparison of both doses of BI 1026706 to placebo and pregabalin in the capsaicin~          treatment~        -  Exploration of the pharmacokinetics of BI 1026706~        -  Exploration of safety and tolerability of BI 1026706~   "
116918|NCT02037152|"~     The purpose of this study is to test a smartphone-based mindfulness training program for~     chronic pain. Research participants use a 20 minute app-guided audio program six days per~     week. The study hypothesis is that training in this technique over a period of four weeks~     will reduce pain interference with daily life activities. This study does not require any~     travel or in-person contact with research staff-- all elements of the study are completed on~     the participant's smartphone.~   "
116919|NCT02037139|"~     Hearing loss screening rates in for older persons in primary care clinics are very low even~     though hearing loss is relatively common for older persons. When diagnosed with hearing loss~     older persons are often reluctant to follow through. This study involves a prospective~     controlled trial comparing the effectiveness of three primary care based protocols for older~     adults ≥ 60 who screen positive for possible hearing loss in promoting subsequent access to~     and use of hearing health care services. The protocols will compare: 1) screening only~     (standard care control); 2) screening plus an illustrated educational brochure; and 3)~     screening plus an in-person educational intervention and an illustrated educational brochure.~     Screening will be done by primary care personnel. Participants will be tracked for 8 months~     to assess outcomes.~   "
116920|NCT02037126|"~     The primary purpose of this study is to evaluate the feasibility and estimate the efficacy of~     psilocybin-facilitated treatment for cocaine use. We also will monitor the impact of~     psilocybin-facilitated treatment on the use of other drugs and outcomes relevant to cocaine~     involvement (e.g., criminal involvement).~      MRI assessment is a unique aspect of this study. As a potential biological mechanism of~     psilocybin's effect includes changes in default mode network functional connectivity~     (Carhart-Harris et al., 2012), we will determine if psilocybin's therapeutic effects are~     mediated by such changes. Moreover, as Glx (a brain metabolite that reflects glutamate)~     abnormalities have been shown to play a role in cocaine addiction, we will determine if~     psilocybin impacts Glx in the anterior cingulate cortex and hippocampus.~   "
116934|NCT02036944|"~     The purpose of this study is to determine if patients with unexplained iron deficiency have~     underlying diseases processes such as celiac disease.~      It is hypothesized that selectively screening patients with unexplained iron deficiency will~     reveal previously undiagnosed etiologies, including celiac disease and other causes of iron~     malabsorption along with various sources of occult GI blood loss.~   "
116935|NCT02036931|"~     The primary purpose of this study is to evaluate the clinical and radiographic performance of~     the G7 Acetabular Cup System.~   "
116921|NCT02037113|"~     This is a prospective, single-center study. The patients with peripheral arterial disease who~     underwent abdominal aortograms with runoff (which are arteriograms of the lower abdominal~     aorta and arteries in the legs) and Intravascular Ultrasound after stent deployment will be~     enrolled in the study. All patients who participated in the study will be treated according~     to standard of care.~      HYPOTHESIS The higher degree of plaque burden on landing zone has an effect on restenosis on~     peripheral artery intervention.~      SPECIFIC AIMS~        1. To determine intravascular ultrasound parameters of stent deployment and outcomes of~          Femoro-popliteal Disease~        2. To determine clinical risk factors and outcomes of Femoro-popliteal Disease~        3. To obtain data that will eventually support development of a predictive model for ISR in~          Femoro-popliteal Disease~      METHODOLOGY Visit 1: After consent is given~      The subject will receive standard follow-up care. A member of the research team will collect~     information such as the subject's age, sex, ethnicity, and medical information from the~     subject's medical record.~      Visits 2-5: 1 day after enrollment, and at months 3 (+- 2 weeks), 6 (+- 2 weeks), and 12 (+-~     2 weeks)~      The subject will complete standard follow-up appointment at TTUHSC. This may include a~     Doppler ultrasound.~      A member of the research team will record information such as medications, ultrasounds, and~     need for additional care related to the subject's stent.~      The subject will complete the questionnaire on leg pain and mobility.~   "
116922|NCT02037100|"~     SDB has been identified as an important risk factor for insulin resistance and the metabolic~     syndrome.~      In a recent study in patients with SDB and T2DM it was shown that CPAP therapy can lead to~     improvements in postprandial glucose levels and in glycosylated hemoglobin levels (HbA1c).~      In children, there are only 3 studies that have examined the relations between SDB, obesity~     and the metabolic syndrome.~      In order to further understand the relative contribution of SDB to the development of~     impaired glucose homeostasis and metabolic abnormalities we aim to investigate the prevalence~     and severity of SDB in children with T2DM compared to obese children without T2DM. The~     investigators hypothesize that SDB will be more prevalent and more severe among obese~     children with T2DM compared with the general obese pediatric population.~   "
116923|NCT02037087|"~     It is hypothesized that delivering short messages (SMS) to pregnant women can improve~     maternal and newborn health outcomes. This pilot offers mothers-to-be in rural China free~     daily short messages (SMS) via cell phone. The aim is to advise them on (a) good household~     prenatal practices (GHPP) and (b) care seeking (CS) in order to improve the quality of life~     for mothers and newborns.~   "
116924|NCT02037074|"~     This is a randomized, double-blind, placebo-controlled, sequential cohort, ascending oral~     dose study of the safety, tolerability, pharmacokinetics, and pharmacodynamics of EVP-6308~     administered for 14 days in subjects with schizophrenia who are on a stable anti-psychotic~     regimen.~   "
116925|NCT02037061|"~     This is a randomized controlled trial to determine if intraoperative local analgesia~     administered at the level of the sacrospinous ligament can lessen the gluteal pain felt by~     patients postoperatively after SSL colpopexy.~      Hypothesis: Local analgesia administered at the level of the sacrospinous ligament can lessen~     the gluteal pain felt by patients postoperatively after SSL colpopexy.~   "
116926|NCT02037048|"~     This phase II trial studies how well oxaliplatin, leucovorin calcium, and fluorouracil~     followed by surgery and response based concurrent chemotherapy and radiation therapy works in~     treating patients with cancer of the esophagus, gastroesophageal junction, or gastric cardia.~     Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, fluorouracil,~     paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either~     by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x~     rays to kill tumor cells. Giving chemotherapy followed by surgery and response based~     chemotherapy and radiation therapy may kill more tumor cells.~   "
116927|NCT02037035|"~     This study is looking at the mechanisms underlying the behavioral effects of ketamine in~     healthy and depressed individuals.~   "
116928|NCT02037022|"~     This is a research study examining the effectiveness of a pivotal response treatment package~     (PRT-P) in targeting language skills in young children with autism.~   "
116929|NCT02037009|"~     In France, cataract surgery is the most frequent surgical procedure, performed with local~     anesthesia and most often very light techniques using eye-drops. Technical improvements of~     surgical and anesthesic procedures have led many countries to implement alternative~     surveillance procedures. In France, it is mandatory that the persons in charge of anesthetic~     surveillance (doctors or nurses) should be qualified in anesthesia.~      In this study, the investigators aim to assess the feasibility and safety of a centralised~     monitoring station outside of the operating rooms, as an alternative to the presence of 1~     anesthetic nurse in each operating room.~   "
116930|NCT02036996|"~     The objective of this study is to collect heart rate, respiration data and motion data of~     patients admitted to sleep lab and to determine the current accuracy level of the EarlySense~     system vs. the standard system, and predicate device for EarlySense (Embla) used in sleep lab~     in monitoring heart rate and respiration rates monitors (ECG, respiratory belts, oximeter)~     that are currently used in the sleep lab among different population (Obese, patients with or~     without apnea, patients with or without arrhythmia). It is emphasized that no interpretations~     or clinical decisions will be made based on data received from the ES study device.~   "
116931|NCT02036983|"~     Comparison of an ultrasound guided bilateral TAP (transversus abdominis plane) block with~     dexamethasone and preperitoneal instillation of local anesthetic with dexamethasone under~     direct visualization will be compared it to a standard anesthetic technique (control)~     following a TEP (total extraperitoneal) bilateral hernia repair. The investigators are~     hypothesizing that the bilateral TAP block and preperitoneal instillation of local~     anesthetics with the addition of dexamethasone are superior in terms of patient satisfaction~     and post-operative pain control when compared to a standard anesthetic technique (no regional~     technique).~   "
116932|NCT02036970|"~     This study assesses the safety and efficacy of bardoxolone methyl relative to placebo in~     patients with pulmonary hypertension to determine the recommended dose range, evaluate the~     change from baseline in 6-minute walk distance (6MWD) and determine the effect of Bardoxolone~     methyl in pulmonary hypertension associated with connective tissue disease, interstitial lung~     disease, and idiopathic etiologies, including subsets of patients with WHO Group III or WHO~     Group V PH following 16 weeks of study participation.~   "
116939|NCT02036879|"~     The objective of this study is to investigate the impact of hormones on lung disease in~     Cystic Fibrosis (CF) patients. Due to improved therapies, CF patients are living longer and~     healthier lives than they did 20 years ago. However, females have been shown to have a~     survival disadvantage. The median life expectancy is 33 in women and 37 in men with CF. The~     hypothesis is that estrogen and/or progesterone negatively impact lung health in CF.~     Therefore, understanding the impact of sex hormones (including the use of birth control~     pills) on the disease process is increasingly important. The purpose of this study is to~     determine if lung function, respiratory symptoms, or various markers of lung health change~     during different phases of the natural ovulatory cycle in order to understand if estrogen or~     progesterone hormones are impacting the disease relative to fluctuations in men with stable~     testosterone levels. The research objectives of this project are to:~        -  Determine if lung function, respiratory symptoms, or various markers of lung health~          change during different hormonal phases of the ovulatory cycle in women.~        -  Determine if men change lung function, respiratory symptoms, or various markers of lung~          health over time.~        -  Determine if oral contraceptive pills in women stabilize fluctuations in symptoms and~          improve lung health.~   "
116940|NCT02036866|"~     To determine differences in thigh muscle function in individuals with and without knee~     arthritis, and also determine the effectiveness of common physical therapy interventions on~     clinical and patient oriented outcomes.~   "
116941|NCT02036853|"~     This study is being done to assess the safety and long-term efficacy of triheptanoin in~     pediatric patients with Glut1 DS over a 5-year treatment period. Glut 1 is a protein that~     helps transport glucose to the brain. Glucose is the brain's primary source of energy. Glut 1~     DS prevents this protein from being effectively produced, causing deprivation of energy to~     the neurons of the of the brain.~      Glut1 DS is a severely debilitating disease characterized by seizures, developmental delay~     and movement disorder. There are currently no approved treatments specific to Glut1 DS.~     Treatment generally includes medications for control of seizures. The use of a ketogenic diet~     can be effective in controlling seizures when medications are ineffective or provide~     insufficient control. However, the ketogenic diet may be very difficult for patients to~     maintain for long periods of time, and there may be negative secondary long-term effects of~     ketogenic diet.. Triheptanoin is metabolized to molecules that can provide an alternative~     energy source to the brain, and appears to help in controlling seizures without many of the~     difficulties of the ketogenic diet.~      Eligible patients may be those who have been diagnosed with GLUT1 DS, and have discontinued~     or are not currently on ketogenic diet, or are able to tolerate triheptanoin if they have~     been treated or are currently being treated with triheptanoin and do not qualify for any~     other clinical trial.~   "
116942|NCT02036840|"~     The proposed research project will retrospectively review the anesthetic records over the~     past 5 years and identify patients who present with a history of penicillin allergy or~     allergy to an antibiotic in the penicillin family. The reason for that history and the facts~     on which that allergy are noted will be determined. Additionally, the choice of antibiotic~     prophylaxis will be recorded and any adverse effect to that antibiotic noted. We will also~     note whether appropriate timing of the antibiotic is achieved.~   "
116943|NCT02036827|"~     The purpose of this study was to investigate whether there is any difference in incidence of~     shoulder tip pain after laparoscopic cholecystectomy between the groups with moderate~     neuromuscular block and deep neuromuscular block.~   "
116944|NCT02036814|"~     The aim was to test if interpersonal relationships group strategies provided by nursing can~     promote an additional benefit on blood pressure (BP) control and quality of life (QoL) in~     hypertensive patients. Methods: 21 treated patients were randomized into two groups: Group A~     10 patients (8 women), underwent to a health educational orientation program~     (inter-relational strategy), with group meetings every 15 days during 4 months(8 meetings).~     Group B 11 patients (7 women), who underwent group orientation by the nurse every 40 days~     during 4 months (3 meetings). Both groups received the same content guidelines (healthy~     lifestyle and prevention of risk factors). The patients had 2 visits by nurses at baseline~     (15 days) and at the final study (120 days). BP was measured by auscultatory method and QoL~     questionnaire (WHOQoL-Brief)was applied. The dispensing and pill counts were done every 30~     days. Ambulatory blood pressure monitoring (ABPM) was performed at baseline and after 120~     days.~   "
116945|NCT02036801|"~     Aim of this study is to assess lung specific elastance in a population of pediatric patients~     with Acute Respiratory Distress Syndrome (ARDS) treated with mechanical ventilation, and in a~     pediatric population of ICU patients with healthy lung which are treated with mechanical~     ventilation for other clinical purposes.~   "
116946|NCT02036788|"~     Esophageal pressure measurement, obtained with the use of an esophageal balloon catheter, is~     fundamental to assess mechanical characteristics of the respiratory system during mechanical~     ventilation. The correct positioning of the catheter (usually at the medium third of the~     esophagus) is crucial for an accurate measurement of esophageal pressure. Usually the correct~     positioning of the catheter is verified with an occlusion test (If the patient is breathing~     spontaneously) or with thoraco-abdominal compressions (if the patient is sedated and~     paralyzed). Aim of this study is to compare the accuracy of these two methods at different~     PEEP and esophageal catheter positions.~   "
116947|NCT02036775|"~     To characterise pharmacokinetics and assess the relative bioavailability of two new oral~     formulations of ambroxol hydrochloride as Lasolvan® prolonged-release hard capsules 75 mg and~     Lasolvan® effervescent tablets 60 mg compared to Lasolvan® tablets 30 mg~   "
116948|NCT02036762|"~     THE AIM OF THIS STUDY IS TO TEST IF THE STRETCHING OF THE RESPIRATORY ACCESSORY MUSCLE~     PROVIDE SOME BENEFIT ON THORACOABDOMINAL MECHANICS, FUNCTIONAL CAPACITY, PSYCHOLOGICAL AND~     SOCIAL ASPECTS IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE~   "
116949|NCT02036749|"~     The Quadratus Lumborum (QL) Block is an ultrasound-guided technique described by Rafael~     Blanco in 2007. The nerves to the lower abdominal wall can be anesthetized by injecting local~     anesthetics close to the anterior border of the quadratus lumborum muscle. In our randomized,~     controlled, double-blinded study ultrasound-guided QL-blocks in 20 female patients after~     cesarean delivery will be compared with a placebo control group of 20 patients to investigate~     analgesic consumption, pain level, opioid related side effects and mobilization.~   "
117772|NCT02025972|"~     This open-label study aims to analyze cytokines related to clinical outcomes of allogeneic~     umbilical cord blood therapy for children with cerebral palsy.~   "
116950|NCT02036736|"~     The recovery of cognitive and psychomotor functions is best performed under anesthesia after~     desflurane when propofol in that obtaining a Aldrete score> 8/10 output of the allowing SSPI.~      The principal objective is to compare the cognitive and psychomotor status of patients~     recovered an Aldrete score> 8/10 according to the anesthetic agent (propofol or desflurane)~     using three tests (Stroop test, Digit Symbol Substitution task and a test of verbal memory~     (visual verbal learning test) made SSPI.~   "
116951|NCT02036723|"~     GALATIR is a double blind randomized clinical trial comparing efficacy and safety of BCD-021~     (bevacizumab) and Lucentis® (ranibizumab) in patients with neovascular wet age-related~     macular degeneration. The purpose of the study is to demonstrate the non-inferiority of~     efficacy and safety of BCD-021 compared to Lucentis®.~   "
116952|NCT02036710|"~     Background: Physicians do not have a unified, scientifically tested theory of causation for~     obesity and its comorbidities, nor do they have explanations for the mechanics of the~     metabolic/bariatric surgery procedures. Integral to proffered hypotheses are the actions of~     the hormones glucagon-like peptide (GLP-1), peptide YY (PYY), and leptin.~      Study objective: To obtain blood levels of GLP-1, PYY, and leptin after stimulation of the~     terminal ileum and cecum by a static infusion of a food hydrolysate in morbidly obese~     patients undergoing a duodenal switch procedure.~      Methods: Plasma levels of GLP-1, PYY, and leptin were obtained at 0, 30, 60, 90, and 120~     minutes after instillation of 240 ml of a food hydrolysate into the ileum or cecum.~   "
116953|NCT02036697|"~     We propose to study the effects on hemodynamics (blood pressure, cardiac output, and central~     venous pressure) of two doses of bupivacaine for spinal anesthesia during cesarean section: a~     higher dose of 12 mg to a lower dose of 4.5 mg. We will examine recovery times, incidence of~     hypotension, and compare pain control and maternal satisfaction during and after cesarean~     section.~      We hypothesize that low dose bupivacaine spinal anesthesia will provide equivalent anesthesia~     for cesarean section compared to conventional dose bupivacaine, with less hypotension, faster~     recovery time, and enhanced maternal satisfaction. Maternal satisfaction will be assessed by~     self-reported pain scores, incidence of nausea and vomiting, shivering, and ability to~     interact with baby in the OR.~   "
116954|NCT02036684|"~     Radical prostatectomy is the most common and effective treatment for localized prostate~     cancer. Unfortunately, radical prostatectomy is associated with significant adverse effects,~     such as urinary incontinence, sexual dysfunction, and reduced physical function that~     collectively diminish health-related quality of life which may persist for up to two years~     postoperatively. The primary objective of this trial is to assess the feasibility of~     conducting of a multi-site randomized controlled trial to test the effect of a comprehensive~     prehabilitation program versus standard care for men with prostate cancer undergoing radical~     prostatectomy. We hypothesize that men with prostate cancer undergoing radical prostatectomy~     in the comprehensive prehabilitation program (full-body exercises and pelvic floor muscle~     exercises) will report better health-related quality of life, urological symptoms, and~     physical fitness, physical activity, and pain, as well as a shorter postoperative length of~     stay than participants receiving standard preoperative care (pelvic floor muscle exercises~     alone). Our secondary objective is to report estimates of efficacy on several clinically~     important outcomes for this population that will be used for sample size calculations in an~     adequately powered trial.~   "
116955|NCT02036671|"~     The objective of this study is to evaluate the safety and efficacy of the FLEX System when~     used to create an arteriovenous fistula (AVF or AV fistula) percutaneously in patients with~     Chronic Kidney Disease (CKD) who require hemodialysis vascular access.~   "
116956|NCT02036658|"~     The purpose of the study is to investigate the immediate and longer-term impact of~     Cognitive-Behavioral Group Therapy (CBGT) versus Mindfulness-Based Stress Reduction (MBSR)~     for patients with Social Anxiety Disorder.~   "
116957|NCT02036645|"~     The purpose of this study is to assess the safety, drug levels and effects on the body of 1~     or 3 injections of MEDI1814, in people with mild to moderate Alzhiemer's Disease or healthy~     elderly people.~   "
116958|NCT02036632|"~     First, this study will investigate the viability of 24-hour eye patching as a potential~     treatment modality for CSR. Second, this study will assess a potential physiologic~     explanation for CSR, namely if inhibition of photic stimulation of the diseased retina will~     aid in ameliorating disease severity and disease duration.~   "
116959|NCT02036619|"~     The General hypothesis is that the IADPSG screening strategy for gestational diabetes (GDM)~     will lead to an important increase in the work load and the prevalence of GDM in Belgium but~     that this might not be cost effective concerning the prevention of adverse pregnancy~     outcomes. The risk to develop type 2 diabetes postpartum will probably be lower than for~     women diagnosed with the two-step screening strategy.~      In this prospective multicentric cohort study, women will be universally screened for~     pregestational diabetes and GDM at the first prenatal visit during the first trimester by~     measuring the fasting plasma glucose. In the second trimester, women without diagnosis of~     diabetes or GDM in the first trimester, will be universally screened for GDM using the 50g~     glucose challenge test (GCT) and the 75g oral glucose tolerance test (OGTT) with the IADPSG~     criteria for GDM. Diagnosis of GDM will be based on the 75g OGTT.~   "
116960|NCT02036606|"~     Racing thoughts relate to subjective acceleration of thinking which has been essentially~     associated with manic episodes in bipolar disorder. Qualitatively, the phenomenology of~     racing thoughts in major depression seems to differ from rumination and pure manic racing~     thoughts: thoughts of all kinds accumulate in the patient's head. Recent qualitative evidence~     is consistent with the existence of these two kinds of thought overactivity related to mood~     disorders. In order to evaluate this and better understand the psychopathological and~     cognitive mechanisms that underlie thought overactivity in mood disorders, we have created a~     34-item self-questionnaire - the Racing and Crowded Thoughts Questionnaire (RCTQ) and a~     number of neuropsychological tasks (time perception, cognitive flexibility). Also, given the~     relationship between mood disorders and creativity, it is likely that thought overactivity is~     related to increased creativity. We aim at evaluating this relationship through the French~     version of the Cognitive Processes Associated with Creativity scale (CPAC).~   "
117175|NCT02033785|"~     Holmium laser prostatectomy will enhance voiding function.~      Holmium laser prostatectomy will enhance sleep quality.~      Holmium laser prostatectomy will enhance renal function.~      Holmium laser prostatectomy will enhance erectile function.~      Holmium laser prostatectomy will enhance the health-related quality of life.~   "
116961|NCT02036593|"~     The Specific Aims for CATCH: PATH are:~      Specific Aim 1: To promote cardiovascular health through implementation and evaluation of a~     multilevel CBPR intervention (i.e., individual, family, organizational levels) to increase~     opportunities for active living, specifically walking groups, in three communities in~     Detroit.~      Specific Aim 2: To promote cardiovascular health through implementation and evaluation of a~     multilevel CBPR intervention (i.e., organization, community, policy levels) to promote~     leadership development, community action, and policy level change to enhance neighborhood~     environments that support and sustain active living.~      Specific Aim 3: To maintain and evaluate the HEP CBPR partnership engaging members of the~     partnership in providing scientific and community oversight for all aspects of the CATCH:~     PATH project.~      Specific Aim 4: To disseminate preliminary results and develop a comprehensive Dissemination~     Plan to share research findings through community and peer reviewed outlets to assure~     translation of results from this multilevel CBPR intervention into programmatic and policy~     efforts to improve heart health in eastside, northwest and southwest Detroit.~   "
116962|NCT02036580|"~     The purpose of the study is to evaluate the safety and tolerability of multiple-doses of~     tralokinumab in Japanese patients with Idiopathic Pulmonary Fibrosis.~   "
116963|NCT02036567|"~     This longitudinal observational study will attempt to objectively measure pain with an~     experimental, non-invasive device. Patients and volunteers will receive a baseline screening~     with psychophysical tests and questionnaires. Investigators will apply the device to measure~     pain during routine clinical care and correlate patients pain ratings and analgesia~     requirements to that measured by the device. A more standardized approach with experimental~     pain stimuli will be pursued in human volunteer studies.~   "
116964|NCT02036554|"~     To evaluate prevention effect of combination therapy of Everolimus and low-dose Tacrolimus in~     comparison with standard-dose Tacrolimus therapy with Mycophenolic acid on the New Onset~     Diabetes Mellitus after transplantation in the renal allograft recipients~   "
116965|NCT02036541|"~     To establish the safety and performance of the AqueSys XEN 45 Glaucoma Implant in eyes with~     refractory glaucoma.~   "
116966|NCT02036528|"~     The purpose of this study is to determine whether AppliGel-G (Gentamicin topical gel) plus~     oral Ciprofloxacin / Doxycycline are safe and effective in the treatment of mild to~     moderately infected foot ulcers in diabetic patients.~   "
116967|NCT02036515|"~     This is a safety and efficacy study of ertugliflozin (MK-8835/PF-04971729) in the treatment~     of participants with type 2 diabetes mellitus who have inadequate glycemic control on~     metformin and sitagliptin. The primary objective of the trial is to assess the hemoglobin A1C~     (A1C)-lowering efficacy of the addition of ertugliflozin compared to the addition of placebo~     with an underlying hypothesis that addition of treatment with ertugliflozin provides greater~     reduction in A1C compared with the addition of placebo; the primary objective will be tested~     for both 5-mg and 15-mg doses of ertugliflozin.~   "
116968|NCT02036502|"~     This is a study of pembrolizumab (MK-3475) in combination with lenalidomide and low-dose~     dexamethasone in participants with refractory or relapsed and refractory Multiple Myeloma~     (rrMM), and in combination with carfilzomib and low-dose dexamethasone in participants with~     relapsed or refractory Multiple Myeloma (rMM).~      This study is being done to find the maximum tolerated dose (MTD)/maximum administered dose~     (MAD) and recommended Phase 2 dose (RP2D), and to evaluate the safety and tolerability of~     pembrolizumab when given in combination with standard of care (SOC) treatments in~     participants with rrMM or rMM. Preliminary efficacy data will also be assessed. The primary~     study hypothesis is that these combinations are sufficiently well tolerated to permit further~     clinical investigation.~      On 03-Jul-2017, the United States Food and Drug Administration (US FDA) placed Cohort 1 of~     this protocol on clinical hold based on safety data from two other pembrolizumab protocols:~     MK-2375-183 (NCT02576977) and MK-3475-185 (NCT02579863) presented to the Data Monitoring~     Committee.~      On 15-Sep-2017, the US FDA placed Cohort 2 of this study on partial clinical hold. Enrollment~     has been stopped and will not be reopened. Participants who are deriving clinical benefit~     will be allowed to continue receiving study treatment until protocol-specific end of~     treatment, and then progress into long term safety and survival follow up. Participants who~     are not deriving clinical benefit, must stop study treatment and move into the long term~     safety and survival follow up.~   "
116969|NCT02036489|"~     Understand the dynamics of elimination of MRD in adult patients with standard-risk LAL~     treated with a pediatric protocol.~   "
116970|NCT02036476|"~     This is an open-label, non-randomized, phase 2 study to assess the feasibility of using~     cabozantinib in recurrent/metastatic Merkel Cell Carcinoma patients that progressed after~     platinum-based therapy.~   "
116971|NCT02036463|"~     Duchenne muscular dystrophy (DMD) is a progressive neuromuscular disease for which no~     curative treatment has yet been identified, making it important to slow progression and~     improve the quality of life among affected boys and young men. Treatment with corticosteroids~     is standard of care for patients with DMD five years old and older, due to the robust~     observation that this intervention lengthens the interval prior to loss of ambulation but is~     associated with many side effects. This clinical trial will be conducted in the youngest age~     group able to receive corticosteroids orally and on whom study outcomes are measurable, ages~     3 to 7 years. This is a randomized, double blinded, double masked, placebo-controlled~     clinical trial that will explore whether better synchronization of corticosteroid~     administration with the circadian rhythm will provide improved tolerability and at least~     comparable efficacy to current standards in which corticosteroids are always given in the~     morning. Furthermore, the trial provides a unique opportunity to rigorously evaluate~     corticosteroid effects in the young DMD patient, both for efficacy as compared to placebo and~     as a study of the impact of corticosteroid chronotherapy, or delayed release, on increased~     tolerability over standard therapy. The main hypothesis is that synchronization of the timing~     of corticosteroid dosing will improve medication tolerability in children, while maintaining~     (non-inferiority) the efficacy of corticosteroid. The study also offers a unique opportunity~     to measure several biomarkers as well as novel genetic modifiers that may further impact the~     response to corticosteroid in DMD.~   "
117176|NCT02033772|"~     The study is primarily a descriptive study examining the physiological, ventilatory,~     surgical, and recovery effects of patients ≤ 6 months of age who undergo thoracoscopic~     surgery and to determine the accuracy of transcutaneous CO2 (TC-CO2) and end-tidal CO2~     (ET-CO2) during high frequency oscillatory ventilation (HFOV) and thoracoscopic procedures.~   "
116972|NCT02036450|"~     The LOOP study aims to clarify whether stroke and peripheral emboli can be prevented by~     monitoring the heart rhythm with a small device (called a loop recorder). The recorder which~     is placed under the skin on the front of the chest wall allows monitoring of the heart rhythm~     24-hours a day 7 days a week.~      The study has 6,000 participants with risk factors for stroke (age >70 years, and at least~     one of the diseases: diabetes, hypertension, heart failure or previous stroke) but without a~     history of atrial fibrillation, of which 1,500 will have a loop recorder implanted and 4,500~     will be included in a control group. Participants are randomised to receive a loop recorder~     or not (control).~      If a participant has atrial fibrillation of more than 6 min duration the study participant~     will start oral anticoagulation therapy according to local guidelines.~   "
116973|NCT02036437|"~     To test the safety and efficacy of titrated oral misoprostol compared to vaginal dinoprostone~     for labor induction.~   "
116974|NCT02036424|"~     To determine if there is visual benefit with Ozurdex treatment every three months compared to~     monthly anti-VEGF alone, in subjects with persistent diabetic macular edema. The investigator~     hypothesizes more frequent administration of Ozurdex in patients that have persistent~     diabetic macular edema will result in a more rapid and sustained improvement of visual acuity~     and/or optical coherence topography (OCT) compared to the use of anti-VEGF alone.~   "
116975|NCT02036411|"~     100mg clomiphene citrate used for ovulation induction. The investigators take blood sample at~     3 and 10 days of menstruation and count AMH and inhibin B.~   "
116976|NCT02036398|"~     Comparison of complications between standard upper pole percutaneous nephrolithotomy (PCNL)~     with nephrostomy placement and double J stent and PCNL with double J placement only without~     nephrostomy.~   "
116977|NCT02036372|"~     The incidence of diabetes mellitus type II is increasing. More and more patients who need~     surgery have diabetes mellitus type II. Despite an enormous amount of glucose lowering~     protocols and the proven negative effects of hyperglycaemia. There is no evidence for the~     optimal glucose lowering protocol.~      This study investigates the optimal intraoperative treatment algorithm to lower glucose in~     patients with diabetes mellitus type 2 undergoing non-cardiac surgery, comparing~     intraoperative glucose-insulin-potassium infusion (GIK), insulin bolus regimen (BR) and GLP-1~     (liraglutide, LG) treatment.~   "
116978|NCT02036359|"~     To compare clinical response (complete response and partial response) by RECIST) rates by~     RECIST between erlotinib monotherapy and docetaxel plus cisplatin chemotherapy~   "
116979|NCT02036346|"~     One of the main reasons for hospital readmission in ileostomy patients is fluid and~     electrolyte abnormalities. Prospective observational studies have suggested an occurrence~     rate of around 20%. Due to colonic exclusion ileostomy patients lose large amounts of sodium~     and fluid through their stoma effluent. In addition studies have shown that ileostomy~     construction is a risk factor for renal impairment, occurring secondary to dehydration.~      Encouraging patients to increase total fluid intake seems to be a common mistake in clinical~     practice as this can dilute sodium levels even more, causing greater sodium depletion. In~     terms of addressing the problem a few small studies have used isotonic drinks of various~     compositions showing increased electrolyte absorption.~      Other dietary complications sometimes include hypomagnesaemia and decreased absorption of~     B-12 and folic acid, however due to the integrity of the small intestine other nutrient~     malabsorption is unlikely to occur. As far as body composition is concerned obesity has been~     shown to be a risk factor for peri- and postoperative complications in colorectal surgery~     (e.g. peristomal dermatitis, stoma stenosis and prolapse). A prospective trial examining~     measures that can prevent readmission for dehydration and other nutritional considerations~     related to this group of patients is definitely required.~      Hypothesis:~      The administration of an oral rehydration solution will allow a significant decrease in~     dehydration and electrolyte abnormality rates in patients with a temporary ileostomy.~   "
116980|NCT02036333|"~     The purpose of this study is to determine whether there is a difference in cerebral~     oxygenation as measured by near-infrared spectroscopy (NIRS) in children with concussion and~     healthy controls.~   "
116981|NCT02036320|"~     The purpose of this clinical trial is to compare the overall lens fit acceptance of two~     different soft contact lenses in an Asian population.~   "
116982|NCT02036307|"~     This is a trial of two marketed fish oil supplements, one with a high EPA:DHA ratio and the~     other with a high DHA:EPA ratio, to examine differential effects on platelet function, blood~     pressure, and fasting triglyceride levels.~   "
116983|NCT02036294|"~     This study involves development and testing of a patient and family-centered transitional~     care program for patients who are hospitalized with Chronic Obstructive Pulmonary Disease~     (COPD) exacerbations. The study intervention includes tailored services to address individual~     patients' biopsychosocial needs, starting early during hospital stay and continuing for 3~     months post hospital discharge.~      The study hypothesis is that compared to usual care, the study intervention will : a) Improve~     patient health- related quality of life and survival, and reduce use of hospital and~     emergency room visits; b) result in improved patient experience, self- confidence, and~     self-care behaviors; c) result in improved family caregivers coping skills, self-confidence,~     and problem solving skills to address patient barriers to care and treatment.~   "
116984|NCT02036281|"~     The subjects will be treated with a single dose of SP-SAP. They will receive the study drug~     SP-SAP via a percutaneous intraspinal catheter, they will be monitored for 4 hours and~     required to stay in the hospital for 24 hours for precautionary care. Their vital signs will~     be monitored and recorded immediately following the injection. After the catheter has been~     removed, the following assessments will be made physical exam including motor and sensory~     functions, and electrocardiogram. A neurologist will be available for consultation as needed.~      Beginning dose of SP-SAP will be 1 -mcg for the first cohort.~      Subsequent single patient dose cohorts as 2, 4, 8, 16, 32, 64 and 90 mcg intrathecally (into~     the spine). SP-SAP will be accrued and treated after four weeks observation for toxicities~     between cohorts.~      Study duration will be up to 6 months from the start of SP-SAP administration.~   "
116985|NCT02036268|"~     This is a randomized study of standard versus extra ostomy education.~   "
116986|NCT02036255|"~     The objective of our study is to investigate whether the substitution of the standard locking~     solution with a locking solution containing taurolidine and urokinase weekly (Taurolock ™ U~     25,000 - www.taurolock.com ) reduces the rate of catheter dysfunction in hemodialysis~     patients with a history of TCC dysfunction requiring urokinase therapy.~   "
116987|NCT02036242|"~     It is common for obstetric anesthesia using opioid supplement to local anesthetics for~     epidural labor pain control. Given the low doses of these epidural drugs, we never doubt the~     necessity of the supplement of opioid to lacal anesthetics during this process based on the~     concept that opioid addition can enhance and prolong the analgesic effect of local~     anesthetics. However, we unavoidably encounter many opioid-associated side effects during the~     labor delivery. In addition, usage of opioid increase the medical cost for each patient. We~     herein hypothesized that in the context of obstetric anesthesia, sole local anesthetics can~     produce as the same analgsic effect as opioid plus local anesthetics given for epidural labor~     pain control.~   "
116988|NCT02036229|"~     The purpose of this study is to determine whether 0.5% ivermectin cream is effective in the~     treatment of demodicidosis (including papulopustular rosacea)~   "
116989|NCT02036216|"~     Circulating free cell DNA (cfDNA) is extracellular fragmentation of nucleic acids that occurs~     both in plasma and serum. This kind of DNA which derived from the apoptotic/necrotic cells or~     the lysis of circulating tumor cells (CTCs) can be detectedin the patients with a variety of~     diseases. Emerging evidence suggests that cfDNA from patients exhibits characteristicchanges~     of tumors, suchas mutations, insertions/deletions, methylations,microsatellite aberrations,~     and copy number variations, etc. All of these reveal a visible difference between the benign~     conditions, and thus may be useful in the diagnosis of cancer, identification of targeted~     therapy, monitor responses to treatments, and early detection of relapse. The purpose for~     this study is to explore these characteristic changes in the patients withhepatocellular~     carcinoma (HCC) and expect to guide targeted therapy and identify non-invasive biomarkers of~     cancer diagnosis and prognosis which can be easily isolated from the circulation.~   "
116990|NCT02036203|"~     This study aims to evaluate the safety and efficacy of the IUB SCu300A spherical copper IUD~     compared to the standard T shaped copper IUD, the TCu380.~      Participants will be followed for one year and quality of life measurements will be measured~     during this period as well.~   "
116991|NCT02036190|"~     The long-term objectives of this ancillary application are to characterize a subpopulation of~     smokers with auto-reactive T cell response, to validate immunodiagnostic assays that could~     detect emphysema, and to find molecular signatures for pathogenic T cell development in a~     well-characterized cohort participating in SPIROMICS (UCSF center).~   "
116992|NCT02036177|"~     The SCu300A IUB™ (hereafter IUB™) will be evaluated for safety and effectiveness in~     comparison with a market approved standard T shaped IUD containing 380sq.mm. of copper:~      Comparison of objective parameters - Pregnancy rate, perforation, expulsion and malposition~     rates, changes in the endometrial thickness, rate of complications such as infection and~     anemia and discontinuation rates after 1 year.~      Comparison of Subjective parameters - pain during insertion, menstrual characteristics and~     pain, bleeding in correlation to the bleeding pattern prior to insertion.~      Physician opinion: ease of use in insertion and removal. Subject satisfaction.~      It is expected that subjects using the copper IUB will demonstrate less safety events, equal~     effectiveness and equal or improved menstrual bleeding and pain related profiles compared~     with users of the T shaped copper IUD.~   "
116993|NCT02036164|"~     Data of survival benefit from adjuvant chemotherapy (ACT) after concurrent chemoradiation~     (CCRT) for locally advanced cervical cancer (LACC) are still limited and inconsistent. We~     will investigate if ACT has survival benefit over CCRT alone.~   "
116994|NCT02036151|"~     The study was designed to determine whether maternal xylitol consumption through regular~     chewing of xylitol gums can affect the salivary mutans streptococci (MS), dental caries, and~     dental plaque levels of their children.~   "
116995|NCT02036138|"~     The growing incidence of obesity and type2 DM globally is widely recognized as one of the~     most challenging contemporary threats to public health. Uncontrolled diabetes leads to~     macrovascular and microvascular complications, including myocardial infarction, stroke,~     blindness, neuropathy, and renal failure in many patients. The current goal of medical~     treatment is to halt disease progression by reducing hyperglycemia, hypertension,~     dyslipidemia, and other cardiovascular risk factors. Despite improvements in pharmacotherapy,~     fewer than 50% of patients with moderate-to-severe type 2 diabetes actually achieve and~     maintain therapeutic thresholds, particularly for glycemic control. Observational studies~     have suggested that bariatric or metabolic surgery can rapidly improve glycemic control and~     cardiovascular risk factors in severely obese patients with type 2 diabetes Few randomized,~     controlled trials have compared bariatric surgery with intensive medical therapy,~     particularly in moderately obese patients (defined as those having a BMI of 30 to 34.9) with~     type2 DM. Accordingly, many unanswered questions remain regarding the relative efficacy of~     bariatric surgery in patients with uncontrolled diabetes. This randomized, controlled,~     prospective multicenter study was designed to compare intensive medical therapy with surgical~     treatment (LRYGB or LSG) as a means of improving glycemic control in moderately obese~     patients (BMI 30-34.9) with type- 2 DM.~   "
116996|NCT02036125|"~     The objective of this study is to evaluate the efficacy of ultrasound guided corticosteroid~     injection in reducing symptoms caused by carpal tunnel syndrome.~   "
116997|NCT02036112|"~     An alternative treatment for low rectal cancer is the extralevator abdominoperineal excision~     (ELAPE) technique. We aim to compare the outcomes of patients undergoing conventional ELAPE~     versus Individual ELAPE.~   "
117019|NCT02035826|"~     Cardiovascular disease (CVD) is the leading cause of death in the United States. Despite~     strong evidence that reducing low-density lipoproteins (LDL) with statins successfully lowers~     CVD risk, physicians under-prescribe statins, physicians fail to intensify treatment when~     indicated, and more than 50% of patients stop taking statins within one year of ﬁrst~     prescription though such therapy typically should be life-long. In this study, we will test~     the effectiveness of different financial incentives in increasing statin use and reducing LDL~     cholesterol among patients with poor cholesterol control who are at very high risk for CVD.~     The application of conceptual approaches from behavioral economics offers considerable~     promise in advancing health and health care. We will test these approaches among patients at~     very high risk of CVD at Harvard Vanguard Medical Associates. Using a 4-arm,~     cluster-randomized controlled trial, we aim to answer these questions: [1] How does the~     provision of patient incentives compare to no incentives at all? [2] Is success with patient~     incentives improved by increasing the financial amounts? [3] Are results sustained after~     incentives and other interventions are withdrawn?~      Study Objectives and Hypothesis~      Aim 1: To evaluate the effectiveness of varying patient incentives on improvement in LDL~     cholesterol relative to usual care during a 3-month intervention among patients at high risk~     of CVD. H1: Each of the incentives will be more effective than usual care in reducing LDL~     cholesterol.~      Aim 2: To evaluate the relative effectiveness of those intervention arms superior to control~     in reducing LDL cholesterol. H2: Higher incentive amounts for patients will be more effective~     than lower incentive amounts.~      Aim 3: To evaluate the impact of each effective intervention in sustaining adherence and~     reduced LDL after the 3-month intervention period.~      Aim 4: To conduct a rigorous process evaluation to examine why some incentives were more~     effective than others and to address other factors relevant to broader implementation.~   "
116998|NCT02036099|"~     Based on the literature on dementia and driving, and on knowledge tools available to date~     including one from our current work, a Driving in Mild Dementia Decision Tool (DMD-DT) will~     be adapted and tailored to guide physicians in their decisions to report a driver with mild~     dementia to the provincial licensing agency. The DMD-DT intervention will include a) an~     algorithm-based computerized clinical decision support system (CCDSS) for facilitating~     driving assessment and physicians' reporting to provincial transportation authorities, b) an~     individualized educational package for patients and caregivers about dementia and driving and~     driving cessation, and c) a modified reporting form to provincial driving regulatory~     authorities. Months 1 to 6: The DMD-DT will be tailored and adapted to practice with the~     input of the co-investigators and knowledge-users who represent the perspectives of~     physicians, patients and their caregivers, as well as transportation authorities. Pilot~     testing will be done, and input from focus groups of knowledge-users will refine the~     intervention. Physicians will be recruited to participate in a clinical trial of the DMD-DT.~     Months 7-18: A parallel-group cluster randomized controlled trial (RCT) will be conducted to~     compare the effects of the DMD-DT to a legislation reminder on recommendations for reporting~     to the licensing agency. The effects of the DMD-DT on the doctor-patient relationship will be~     further explored in focus groups and interviews with physicians. Months 19-24: The knowledge~     obtained from the study will be used to generalize and sustain use of the intervention beyond~     Ontario, Canada, and to disseminate the information to knowledge-users. The primary outcome~     measure is the filing of a report to the Ministry of Transportation of Ontario, indicating~     that the physician has a concern about the patient's health condition (i.e. mild dementia).~     The primary outcome of the study is the difference in reporting between the DMD-DT and~     control arms. Since the current reporting rate is low, approximately 13%, from a public~     health point of view, the primary outcome expected is that physicians in the DMD-DT group~     will report more patients with mild dementia than those in the control group.~   "
116999|NCT02036086|"~     This study will evaluate the clinical and pathological response to vemurafenib and~     cobimetinib in the neoadjuvant treatment of patients with histologically confirmed, BRAF V600~     mutation-positive Stage IIIB and C melanoma. 20 patients will be treated with vemurafenib and~     cobimetinib for 2 months. Then they will be assessed for surgery. Patients will undergo~     surgery and subsequently resume taking vemurafenib and cobimetinib after recovery from~     surgery. Patients will undergo radiation therapy if appropriate then continue vemurafenib and~     cobimetinib. The maximum treatment period is 12 months. After 12 months of treatment,~     patients will be followed for disease recurrence and survival during for a total of 5 years.~   "
117000|NCT02036073|"~     EPO has been safely used for prevent preterm anemia and recent studies have shown the~     neuroprotective effect. Our hypothesis is that EPO could prevent preterm brain injury. The~     aims of this study include: to investigate the safety and efficacy of EPO by using 500u/kg~     higher than the dose of anemia treatment (250u/kg); to evaluate the effect of EPO on~     neurodevelopment in preterm infants; to detect biological indicators and explore the~     neuroprotective mechanism of EPO.~   "
117001|NCT02036060|"~     Prostate cancer is the most frequently diagnosed non-skin cancer, and the second leading~     cause of men cancer death in the United States. Hormonal therapy remains a first-line~     treatment for metastatic prostate cancer. Initial responses to hormonal therapy with chemical~     or surgical castration are quite favorable, however, most patients will progress to a~     castration-resistant phase of the disease. Docetaxel is the primary chemotherapeutic option~     for patients with mCRPC.~      Abiraterone is a novel, selective, irreversible, and potent inhibitor of~     17-[alpha]-hydroxylase/17,20-lyase (CYP17) enzymatic activity that has recently been~     demonstrated to further reduce testosterone levels in the blood to undetectable range (< 1~     ng/dL) and is suggested to reduce de novo intratumor androgen synthesis. Abiraterone~     demonstrated activity in castration resistant prostate cancer patients previously treated~     with docetaxel chemotherapy. Recently, results of a phase III trial comparing abiraterone~     plus prednisone vs placebo plus prednisone in asymptomatic and without visceral metastasis,~     castration-resistant metastatic prostate cancer patients, demonstrated a better radiological~     progression free survival for abiraterone treated patients and a trend towards a better~     survival was clear for abiraterone treated patients.~      No clinical evidence exists about efficacy of chemotherapy and antiandrogen therapy~     combination. All trials have been performed in patients in which LHRH agonist treatment was~     continued although there is not clear evidence about efficacy of hormonal treatment. Some~     retrospective studies suggest that androgen deprivation treatment should be maintained in~     chemotherapy treated patients. Abiraterone has been proved to suppress androgen levels to~     negative values, and to add efficacy to castration hormonal therapy. Combination of~     abiraterone with docetaxel chemotherapy seems promising adding efficacy to only docetaxel~     chemotherapy. A randomized phase II study comparing docetaxel + prednisone + abiraterone to~     docetaxel + prednisone in mCRPC in patients treated previously with abiraterone, seems~     promising to explore addition of efficacy to taxotere after abiraterone hormonal treatment.~   "
117002|NCT02036047|"~     The use of an exclusive cold polypectomy snare enables a clean cut of diminutive colorectal~     polyps, resulting in an increase in the complete resection rate and a decrease in the adverse~     events.~   "
117003|NCT02036034|"~     The investigators hypothesize that this modified ophthalmic draping will reduce the~     accumulation and rebreathing of carbon dioxide during eye surgery.~   "
117004|NCT02036021|"~     Mortality related with cardiac arrest in anesthetized children has diminished over several~     decades from 2.9 per 10000 anesthesias in 1961 to 0.21 per 10000 anesthesias in 2007.(1) Even~     though the mortality rate related to pediatric anesthesia is much lower than before,~     respiratory complications related with peri-operative cardiac arrest are as high as 27%~     according to the Pediatric Peri-operative Cardiac Arrest (POCA) Registry.(2).Therefore,~     peri-operative respiratory event (PRE) in pediatric anesthesia such as laryngospasm, stridor,~     bronchospasm, desaturation and reintubation are crucial.~      Stridor and reintubation occur after the children are extubated, mostly in the PACU period.~     Laryngospasm, stridor, bronchospasm and wheezing can lead to desaturation and the need for~     reintubation. Those PRE, especially peri-operative desaturation, can prolong PACU stay~     especially if PRE develops in the PACU.(8,9) PRE occurring during the intraoperative period~     can also prolong PACU stay if children are observed at PACU and not transferred directly to~     the intensive care unit (ICU). Some children require oxygen therapy in the PACU and continue~     at the ward. Some need endotracheal tube intubation with spontaneous breathing or are placed~     on mechanical ventilator. Thai AIMS (10) reported that desaturation at PACU was associated~     with re-intubation, prolonged mechanical ventilation and unplanned ICU admission. Oxygen~     supplement need, prolonged mechanical ventilation or unplanned ICU admission can produce~     extra days of hospitalization or increase the cost of hospitalization from extra-cost payment~     eg; oxygen therapy, mechanical ventilator, cost of ICU stayed.~      Furthermore, the short-term sequelae regarding cost of hospitalization of children who~     develop PRE has never been evaluated or compared with the cost in children who do not develop~     PRE. Higher cost of hospitalization after occurrence of PRE in anesthetized children will~     have an impact to the hospital policy maker. Minimizing PRE can save on the cost of hospital~     care to the public hospital or other health sectors.~      Therefore, we would like to compare days of hospitalization and cost differences of~     hospitalization between children who develop PRE and children who do not develop PRE at a~     tertiary care hospital in southern Thailand~   "
117005|NCT02036008|"~     The purpose of this study is to determine if Gadofosveset Trisodium (Gdfos, Ablavar) is a~     useful magnetic resonance imaging (MRI) contrast agent in accurately diagnosing liver~     metastases compared to the standard agent gadobutrol (EcGd, Gadovist).~   "
117006|NCT02035995|"~     Gestational diabetes mellitus (GDM) is a risk factor for the development of type II diabetes~     and it is responsible for the morbidity of both mother and child. The aim of this study was~     to determine retinal findings of gestational diabetes mellitus (GDM).~   "
117020|NCT02035813|"~     Several studies have indicated that determining prevalence and number of circulating tumor~     cells (CTCs) at various time points during treatment may be an effective tool for assessing~     treatment efficacy in metastatic breast cancer (MBC). However, even if the prognostic value~     of CTCs in MBC is well understood, the role of both CTC prevalence and CTC phenotype in~     predicting treatment response needs further investigation. DETECT IV is a prospective,~     multicenter, open-label, phase II study in patients with HER2-negative metastatic breast~     cancer and persisting HER2-negative circulating tumor cells (CTCs). Additional research on~     CTC dynamics and characteristics will provide a better understanding of the prognostic and~     predictive value of CTCs and is one step into a more personalized therapy for MBC.~   "
117021|NCT02035800|"~     Broca II is the prolongation of the original study name BROCA. In BROCA study, only 25~     patients participated and it was not enough to concluded clearly our hypothesis.~   "
117007|NCT02035982|"~     There are few pharmacological treatments available for Alzheimer's disease, including drugs~     called cholinesterase inhibitors: donepezil, galantamine, and rivastigmine. In research~     trials, cholinesterase inhibitors have been shown to improve memory and problem behaviours in~     people with mild to moderate Alzheimer's disease. However, these benefits may not extend to~     the real-world when taking into account nursing home and health care costs. There is less~     information on the use of cholinesterase inhibitors in people with severe Alzheimer's~     disease. In Canada, only donepezil is recommended for the treatment of severe Alzheimer's~     disease. However, there is no information on whether the benefits that donepezil provides to~     people with severe Alzheimer's disease are sustained over the long term. Moreover, while the~     tolerability of cholinesterase inhibitors is generally acceptable, their use is not~     completely harmless. Common side effects include nausea, diarrhea, insomnia, vomiting, muscle~     cramping, fatigue and loss of appetite.~      In Ontario, cholinesterase inhibitor users tend to remain on these medications for two years~     or more and often until death. The current cholinesterase inhibitor guidelines provide~     details on what medication should be used, when it should be started and how it should be~     monitored, but there is less clarity on when it is safe and appropriate to stop treatment.~     The cessation of cholinesterase inhibitors in patients no longer appearing to display any~     clear benefits may help to lower the risk of unpleasant side effects, lower the use of~     multiple medications, and reduce the costs of caring for individuals with Alzheimer's~     disease. However, the cessation of cholinesterase inhibitor therapy may run the risk of~     deterioration in memory, worsening or development of behavioural symptoms and the placement~     of additional demands on professional and unpaid caregivers.~      There is a clear need for guidelines when to stop cholinesterase inhibitor treatment,~     especially for patients in whom the benefits of not be on the medication will outweigh the~     risks. The purpose of this study is to address this issue by collecting data which may be~     helpful in predicting which types of patients may benefit from stopping cholinesterase~     inhibitor treatment. Understanding when, and for whom, it is appropriate to stop~     cholinesterase inhibitor treatment will influence the field of pharmacology in the treatment~     of Alzheimer's disease.~   "
117008|NCT02035969|"~     This project aims to assess the effect of group peer support to children with HIV in relation~     to adherence, virological treatment failure as well as physical development. A randomised~     controlled trial (RCT) will be used where HIV+ children on antiretroviral treatment (ARV) and~     their caretakers are randomized into either enhanced treatment support (ETS) through peer~     supporters or the conventional treatment (CT) according to the guidelines of The National~     AIDS Control Program. The treatment strategies will be assessed and compared in relation to~     virological treatment failure as primary endpoint, immunological and clinical (AIDS events~     and mortality) as secondary endpoints as well as treatment adherence and physical~     development. The results from this project will lead to an increased knowledge in relation to~     the impact of enhanced treatment support on adherence, virological suppression and resistance~     development for children with HIV and have an impact on HIV treatment policies and guidelines~     for Pediatric HIV in low-income settings globally.~   "
117009|NCT02035956|"~     Clinical first-in-human study evaluating the safety, tolerability and immunogenicity of~     intra-nodal administration of a personalized vaccination with IVAC MUTANOME vaccine with or~     without initial treatment with RBL001/RBL002 vaccine in patients with advanced melanoma~   "
117010|NCT02035943|"~     In this study the investigators want to comare safety and efficacy of two different metods to~     administrate insulin during parenteral nutrition.~   "
117011|NCT02035930|"~     The study was done to evaluate the effects of the follicular and luteal phases of the~     menstrual cycle on sedation level at loss of consciousness and bispectral index reach to 50~     during propofol anesthesia, in patients with and without preoperative intravenous~     dexmedetomidine .~   "
117012|NCT02035917|"~     this study will perform to compare the results and functional outcomes of tibial plateau~     fractures treated with non-locking and locking plate fixation.~   "
117013|NCT02035904|"~     The aim of the study is to evaluate efficacy and safety of long term (14 days) wound infusion~     with levobupivacaine in patients with breast cancer undergoing mastectomy with immediate~     breast reconstruction: this is a double blind, randomized, parallel group study. The study~     moves from the concept that nociceptive stimulus last further than 48 hours after surgical~     intervention: long term analgesia is necessary to provide a real benefit to the patient and~     provide central sensitization. Intralesional catheter is placed at the end of surgery. In the~     first 24 postoperative hours we provide continuous wound infusion with levobupivacaine 0,25%~     5ml/h with morphine Patient Controlled Analgesia (PCA) when NRS >4. From the second~     postoperative day morphine PCA is removed and patients are randomized to receive~     levobupivacaine 0,25% or saline, released with 5 ml boluses and lock-out of 2 hours, with~     rescue analgesia with tramadol 37,5 mg + acetaminophen 325 mg oral fix combination (Patrol).~     Intralesional catheter is taken off 14 days after surgical intervention or after 36 hours of~     non-use.~      Pain evaluation (NRS at rest and movement) and oral rescue doses consumption are performed;~     pain physicians also care about any catheter-related or drug-related side effect, registering~     number of total boluses. Patients are provided with a home diary for pain scores to be filled~     and brought back when surgical visit is performed. A phone interview at 1 and 3 month is~     performed to investigate pain chronicization.~      Surgical evaluation is provided, also to establish any catheter-related infective or healing~     complication.~      Physiatric evaluation before the intervention and 1 and 3 months is provided to ensure~     rehabilitation process.~      A validated questionnaire (short form 36/ SF-36) must be filled by all patients, to~     understand differences in return to a normal quality of life and to social activities between~     the two groups.~   "
117014|NCT02035891|"~     The study aims to assess：~        1. whether low-dose colchicine could reduce microalbuminuria in patients with type 2~          diabetes and microalbuminuria who have been receiving stable treatment of~          angiotensin-converting enzyme inhibitor/angiotensin II receptor blocker (ACEI/ARB) for~          at least 3 months;~        2. whether low-dose colchicine decreases carotid intima-media thickness(IMT) in patients~          with type 2 diabetes and microalbuminuria;~        3. whether low-dose colchicine slows the progression of microvascular complications in~          patients with type 2 diabetes and microalbuminuria;~        4. whether low-dose colchicine reduces the risk of cardiovascular events in patients with~          type 2 diabetes and microalbuminuria.~   "
117015|NCT02035878|"~     The proposed project will investigate the effects of probiotics on anxiety and associated~     psychological and physiological factors in humans. The therapeutic potential of probiotics~     for reducing anxiety and other factors associated with a disrupted microbiome will be~     assessed in a double-blind placebo-crossover design. Based on the research findings to date,~     it is hypothesized that probiotics will reduce anxiety and depressive symptoms.~   "
117016|NCT02035865|"~     The investigators aim at characterizing neuropsychiatric consequences of heart~     transplantation (HTX) and at assessing the impact of depressive symptoms after HTX on~     mortality and cardiac allograft vasculopathy (CAV).~   "
117017|NCT02035852|"~     The study will compare two different size MRI's of a brain tumor.~   "
117018|NCT02035839|"~     To assess the fraction of subjects surviving with good neurological outcome at 90 days for 3~     different levels of hypothermia, in comatose survivors from out-of-hospital cardiac arrest.~   "
117062|NCT02035254|"~     In this project, individuals at risk for cardiovascular disease who are looking to lose~     weight or increase your level of activity, are offered access to an online lifestyle~     management program.~      Participants will use the website daily to improve their eating and exercise habits as well~     as other aspects of healthy living. They will be asked to participate in online challenges to~     motivate them to make lifestyle changes. Participants will meet with a health professional 3~     times within the 6 month time period as well as receive monthly guidance and support by phone~     or email for the website.~   "
117022|NCT02035787|"~     Purpose: This is an open label, single-arm, single-center study of the addition of metformin~     to standard levonorgestrel-releasing intrauterine device (LR-IUD) treatment of 30 evaluable~     non-surgical patients with either complex atypical hyperplasia (CAH; n=15) or grade 1~     endometrial adenocarcinoma (EC; n=15).~      Participants:Women, over the age of 18 years, with biopsy-proven CAH/EC who are not~     candidates for surgical management, and therefore are planned to start standard of care~     treatment with the LR-IUD~      Procedures (methods): subjects will be given oral metformin therapy for 12 months, or until~     disease progression occurs (whichever occurs first), in addition to LR-IUD treatment. Serial~     endometrial biopsies will be performed, as per standard of care, to assess disease status.~   "
117023|NCT02035774|"~     Patients who receive the lateral and sagittal infraclavicular block (LSIB) tend to supinate~     their hand and forearm which may hamper optimal positioning for surgery of the dorsal side of~     the hand. The investigators think that this supination is caused by lateral rotation in the~     shoulder. The main lateral rotator of the shoulder is the infraspinatus muscle, which is~     innervated by the suprascapular nerve (SSN).The investigators hypothesized that optimal~     positioning of the hand for surgery on the dorsal side of the hand may be achieved by~     performing a SSN block (SSNB) in addition to the LSIB.~   "
117024|NCT02035761|"~     Multiple system atrophy (MSA) is a disorder of the nervous system of unclear cause. In MSA~     there is degeneration (progressive loss) of nerve cells in several brain and spinal cord~     regions. The result is a variety of symptoms, from physical (parkinsonism, ataxia,~     incoordination, falls, slowness) to autonomic (fainting, bladder incontinence, sexual~     dysfunction) to sleep problems (dream enactment, sleep apnea).~      This research aims to help us better understand the patterns and timing of nerve degeneration~     relatively early in the disease, and how this affects symptoms and progression. For instance:~        1. Does MSA affect certain nerves that stimulate heart pumping? If so, does the severity of~          loss of heart nerves affect disease progression and survival?~        2. It is thought that MSA does not affect memory and thinking much, unlike other diseases~          (such as Parkinson's). Is this accurate? Is there loss of nerves that transmit~          acetylcholine (a neurochemical important in mental functioning)?~        3. What can we learn about mood and sleep in MSA, through visualizing the serotonin system~          in the brain? How does this relate to symptoms that subjects report in these often~          underappreciated areas?~      To answer these and other questions, investigators will take images of specific nerves in the~     brain and heart using Positron Emission Tomography (PET) scans. Such imaging gives us~     information that cannot be obtained from MRIs and CT scans. We will measure the levels of~     several nerve cell types: serotonin, acetylcholine, and norepinephrine. Subjects will also~     have many standardized assessments including quality-of-life and symptom assessments,~     neurological examination, autonomic assessments, neuropsychological assessments, coordination~     tests, and even assessments of vision and sense of smell. By pooling these results from many~     MSA patients, and comparing with other diseases (such as Parkinson's disease) we hope to gain~     a better understanding of what is happening early in MSA. Such knowledge could be very~     valuable in future efforts to develop better therapies in this rare disease.~   "
117025|NCT02035748|"~     The purpose of this study is to observe the anatomical and functional outcomes of ocriplasmin~     (JETREA®) over a 6-month follow-up period.~   "
117026|NCT02035735|"~     The aim of this study is to prospectively determine if the use of NBI endoscopy modifies the~     superficial extension of these tumors.~   "
117027|NCT02035722|"~     Intravitreal injection of Ranibizumab (Lucentis, Genentech) is clinically indicated for~     patients with wet age-related macular degeneration (AMD) An disadvantage of this technique is~     the anxiety and discomfort which patients often experience due to the idea of getting a~     needle in the eye. In addition, a recent case study indicated the importance of patient~     education in achieving positive outcomes from intravitreal injections of anti-vascular~     endothelial growth factor (VEGF) agents. The purpose of our study is to determine whether~     visual education on AMD and intravitreal injection can reduce patients' anxiety prior to the~     treatment, and lessen the impact of socioeconomical status on their understanding of the~     treatment and prognosis.~   "
117028|NCT02035709|"~     Treatment of postoperative pain with hydromorphone (a strong analgesic) using~     patient-controlled analgesia with target concentrations in blood compared to conventional~     patient-controlled analgesia after planed cardiac surgery~   "
117029|NCT02035696|"~     To evaluate the safety and immunogenicity of four influenza vaccines in children 6 months to~     < 48 months of age~   "
117030|NCT02035683|"~     The purpose of this study is to test whether an early metabolic response, measured by PET/CT~     scan after the first cycle of chemotherapy, is able to predict which patients with advanced~     NSCLC have a better prognosis.~   "
117031|NCT02035670|"~     The purpose of this study is to determine whether two-step method of diagnostic strategy is~     effective in the diagnosis and treatment of fever of unknown origin (FUO). (TSMD research, a~     pilot study) Fever of unknown origin (FUO) is a fever in excess of 38.3◦C continued for more~     than 3 weeks, and its cause could not be identified by tests during hospitalization for more~     than 1 week [1]. As diagnostic techniques such as imaging technology and clinical tests have~     been developed and outpatient access to diagnostic tests have improved, the FUO is defined as~     a shortened period where the cause could not be revealed despite diagnostic tests during~     three visits to the outpatient department or during 3 days of hospitalization [2]. FUO can be~     caused by many diseases, and causes can vary depending on region and time period. FUO was~     first reported in the medical literature 80 years ago. Since then, the causative diseases~     have greatly changed with changes in the social environment and widespread use of diagnostic~     imaging. The causes of FUO, according to traditional diagnosis and treatment, could be~     divided into four principal groups: infections, non-infectious inflammatory diseases (NIID,~     including rheumatic diseases and vasculitic diseases), neoplasms, and other diseases. Despite~     the development of various diagnostic techniques, 34-51% of FUO patients remain undiagnosed~     [3,4]. In China, over-reliance on antibiotics for disease therapy and infection prevention~     are common phenomena in traditional treatment of FUO[5].~      Two-step method of diagnostic strategy is a method to diagnose FUO disease. First step is to~     differentiate FUO according to the onset of disease and invasive pathogens. Second step is to~     further differentiate FUO according to trends of disease and inflammation scores. The~     diagnosis of FUO can be difficult for both patients and their physicians. Depending on the~     experience and qualifications of the treating physicians, time to reach a diagnosis can vary.~     Two-step method of diagnostic strategy would afford a standard method for physicians to~     diagnoses the FUO.~      So many reports of FUO have also been published in China, but have been limited to~     single-facility or limited-region studies; no nationwide studies have yet been conducted.~     Moreover, few assessments of tests used in the diagnostic evaluation of FUO have been~     reported. In particular, few studies have assessed the clinical usefulness of tests such as~     serum procalcitonin or positron emission tomography (PET) in China, although these tests are~     now frequently used.~      We therefore will conduct a multicenter collaborative retrospective and prospective~     （randomized and controlled ）study of patients with FUO at hospitals affiliated with China's~     Ministry of Health. This is the first nationwide study in China on diseases causing FUO and~     the diagnostic workup, and identified diseases that should be considered when evaluating FUO~     in China. In addition, we will investigate the rate of performing various tests in the~     current diagnostic workup of FUO.~      Classical FUO was diagnosed based on the definition by Durack et al[6] in patients meeting~     all of criteria 1-4 below.~      1. Fever with axillary temperature ≥38°C at least twice over a ≥3-week period. 2. Unknown~     cause after three outpatient visits or during 3 days of hospitalization.~      3. Not diagnosed with immunodeficiency before fever onset. 4. No confirmed HIV infection~     before fever onset. The data described below were collected. No additional testing was~     performed in this study due to insufficient data.~        1. Patient characteristics: sex, age, concomitant disease, medical history and medication~          history.~        2. Clinical findings: subjective symptoms and objective physical findings.~        3. Blood tests: blood count, biochemical examination and inflammatory markers (C reactive~          protein (CRP), erythrocyte sedimentation rate (ESR), procalcitonin, etc.).~        4. Results of blood cultures if performed.~        5. Results of imaging studies and endoscopy if performed.~        6. Results of cytology, histology, genetic testing or autopsy findings if performed.~        7. Final diagnosis, day of diagnosis and outcome. This study is safety for no drug involved~          to determine the effectiveness of two-step method of diagnostic strategy in the~          diagnosis and treatment of fever of unknown origin.~   "
117032|NCT02035657|"~     This is a single arm, open-label, single center study evaluating the safety, feasibility,~     clinical efficacy and immunogenicity of GLA-SE administration to patients with Merkel cell~     carcinoma. Ten patients will be treated. The goal is for GLA-SE to assist the patient's own~     immune system in attacking the cancer cells.~   "
117033|NCT02035644|"~     The aim of the present study is to evaluate the efficacy and safety of Jinlida granules in~     patients with inadequately controlled type-2 diabetes and dyslipidemia under life style~     intervention.~   "
117034|NCT02035631|"~     The main purpose of our study is to assess the effect of a lifestyle intervention combining~     weight control, diet and physical activity on the risk of recurrences among breast cancer~     patients with non-metastatic tumours in terms of 5-year cumulative incidence of recurences.~   "
117035|NCT02035618|"~     Manual therapy combined with a protocol of therapeutic exercises will increase the beneficial~     effects on scapular kinematics, myofascial pain and function in subjects with shoulder~     impingement when compared to exercises only.~   "
117036|NCT02035605|"~     The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of~     ALN-AT3SC in healthy volunteers and Hemophilia A or B patients.~   "
117037|NCT02035592|"~     The purpose of this study is to determine the dose-dependent impact of 6 month freeze-dried~     blueberry powder intake on insulin sensitivity and resistance, cardiovascular disease risk~     factors, and lung and cognitive function in overweight and obese participants with metabolic~     syndrome. We will also examine acute post-prandial effects of blueberry intake (at baseline~     and at 6-months).~   "
117038|NCT02035579|"~     Sports-related concussions are common in adolescent-athletes. Prolonged recovery after~     concussion or post-concussion syndrome (PCS) is a public health problem. This project will~     determine the effectiveness of an aerobic exercise program for management of PCS and it will~     evaluate the influence of exercise on biologic correlates of PCS.~   "
117355|NCT02031432|"~     The purpose of this trial is to find out how well cebranopadol is tolerated and how often,~     and which, adverse reactions occur when it is taken every day for a longer period of time. In~     addition information will be collected how cebranopadol affects pain and well-being in~     patients suffering from cancer-related pain.~   "
117039|NCT02035566|"~     People living in rural areas are at increased risk for poor health outcomes due to: long~     distance to health care facilities, less available health care resources such as primary care~     and specialty services, transportation problems, higher elderly population, poverty, high~     uninsured rates and the lack of timely access to new technologies. Called Telehome Care~     (THC), in the form of equipment in the home, may provide an innovative and potentially~     cost-effective solution to enhancing chronic disease management services using technology and~     may influence the reduction in emergency department (ED) visits and hospitalizations in rural~     areas. However, telehealth research is still in its infancy, it is not well understood, and~     is often done without an overarching scientific framework. The provision of in home health~     monitoring and health education also may be a potential population based health research tool~     for chronically ill patients. Demonstration of the possible benefits, patient acceptance and~     satisfaction with THC requires a scientific approach as is used in this study.~   "
117040|NCT02035553|"~     This study will evaluate the safety and efficacy of pimavanserin 40 mg compared to placebo in~     patients with Alzheimer's disease psychosis.~   "
117041|NCT02035540|"~     This is a prospective, non-randomized, single-arm, multicentre surveillance study to be~     conducted in Europe. The Surveillance is designed as a study, where~        -  ESPOIR PV (pulmonary valve) is prescribed in the usual manner in accordance with the~          terms of the approval.~        -  The assignment of the patient to a particular therapeutic strategy is not decided in~          advance by this Surveillance Protocol but falls within current practice and the~          prescription of ESPOIR PV is clearly separated from the decision to include the patient~          in the Surveillance.~        -  No additional diagnostic or monitoring procedures shall be applied to the patients~        -  and epidemiological methods shall be used for the analysis of collected data.~      Evaluation of decellularized human heart valves for pulmonary heart valve replacement in~     comparison to current valve substitutes. Safety endpoints include cardiovascular adverse~     events, time to re-operation, re-intervention and explantation. Efficacy endpoints include~     freedom from valve dysfunction and hemodynamic performance.~   "
117042|NCT02035527|"~     This phase I/II trial studies the side effects and the best dose of sorafenib tosylate and~     docetaxel when given together with cisplatin and to see how well they work in treating~     patients with recurrent or metastatic squamous cell carcinoma of the head and neck. Drugs~     used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Sorafenib tosylate may also help cisplatin and docetaxel work better by~     making tumor cells more sensitive to the drugs. Giving sorafenib tosylate, cisplatin, and~     docetaxel may be an effective treatment for squamous cell carcinoma of the head and neck.~   "
117043|NCT02035514|"~     Immunomodulatory therapies to treat the relapsing-remitting phase of multiple sclerosis (MS)~     are designed to ameliorate the inflammatory processes that mediate the damage to the central~     nervous system (CNS) and to delay progression of the disease. To date, there is no effective~     means to stop the progression of disease and induce remyelination. Adult stem cells therapy~     show great promise and is rapidly developing as alternative therapeutic strategy. We propose~     the use of bone marrow-derived autologous Mesenchymal (BM-MSC) Stem Cells transplantation to~     treat patients with relapsing-remitting MS (RRMS), despite immunomodulatory therapy. Taking~     advantage of the potential that MSC possess strong immunomodulatory properties thought to~     play a role in the maintenance of peripheral tolerance and in the control of autoimmunity and~     that may stimulate repair and regeneration of lesions, we plan a trial of a single injection~     of autologous BM-MSC into eight patients. First, we aim to assess the feasibility, safety and~     tolerability of autologous MSC therapy in RRMS. Second, we plan to evaluate the effects of~     BM-MSC transplantation on MS disease activity by clinical, neurophysiological, immunological~     and imaging assessments. Autologous MSC will be obtained from bone marrow aspirates, purified~     by culture and characterized by surface antigen expression. A single dose of autologous~     BM-MSC will be injected intravenously. Clinical, neurological and immunological assessments~     will be scheduled at baseline (before BM-MSC transplantation) at 1, 3, and 6 months after~     transplant. The imaging will be performed at 3 and 6 months after transplant. Proposed trial~     will enable us to ascertain whether autologous BM-MSC transplantation is a feasible and safe~     procedure, and whether BM-MSC can establish an environment of immune tolerance and through~     the local production of neurotrophic/growth factors, might induce neuroprotection and~     improvement in CNS function.~   "
117044|NCT02035501|"~     The purpose of the study is to investigate if treatment with L-Tyrosine improves selected~     outcome measures of TNNT1 myopathy.~   "
117045|NCT02035488|"~     Bronchiectasis is a persistent and frequently progressive condition characterized by dilated~     and thick-walled bronchi retaining sputum. The main symptoms of bronchiectasis are cough and~     chronic sputum production. Until now, most patients with non-CF bronchiectasis receive~     inhaled tobramycin every other month, by use of a nebulizer. However, this delivery system~     has several disadvantages, like a low lung deposition and pollution with tobramycin in the~     surrounding environment. With an efficient dry powder inhaler (DPI), a three to six fold~     higher lung deposition compared to a nebulizer can be obtained. Therapy with a DPI is also~     less time consuming compared to nebulisation. We will investigate dry powder tobramycin (DP~     tobramycin) in a novel device in patients with non-CF bronchiectasis. The main objectives of~     this study are to investigate the pharmacokinetic properties of DP tobramycin at different~     dosages together with the local tolerability of DP tobramycin via the Cyclops® at different~     dosages.~   "
117046|NCT02035475|"~     The EndoWrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da~     Vinci Si robotic surgical system. It is intended for bipolar coagulation and mechanical~     transection of vessels up to 7 mm in diameter and tissue bundles that fit within the jaws of~     the instrument. Their use in this study will be to perform tissue transection during PLND~     such that the intended use is within the FDA-approved domain for this instrument.~     Investigators intend to identify whether its use for PLND reduces lymphoceles given that the~     device is known to seal vessels up to 7 mm, which is much larger than lymphatic vessels~     encountered during PLND. Because the instrument is new and has been FDA approved for less~     than one year, there is no published literature regarding its use to date.~      Our hypothesis is that using the Vessel Sealer on a single side of the pelvis will reduce the~     incidence of screening detected lymphoceles on that side. Investigators propose a total~     sample size of 120 patients.~   "
117063|NCT02035241|"~     The purpose of the study was to investigate how herbs and spices affect acute/postprandial~     glucose and insulin responses, inflammatory markers, appetite control peptides, antioxidative~     capacity, as well as subjective appetite ratings (VAS-visual analogue scales) in healthy~     volunteers. We hypothesize that certain herbs and spices added to a standardized meal will~     improve postprandial glucose tolerance and other metabolic biomarkers in healthy volunteers,~     compared with a similar meal without the corresponding plant materials.~   "
117047|NCT02035449|"~     Difficult conditions and critically ill and injured patients may complicate endotracheal~     intubation in the pre-hospital setting. The incidence of complications increase when two or~     more endotracheal intubation attempts are needed.~      The aim of this study is to estimate the incidence of difficult pre-hospital endotracheal~     intubation after the introduction of the McGrath MAC Video laryngoscope as the primary airway~     device for pre-hospital endotracheal intubation.~      Hypothesis:~      • In our pre-hospital critical care teams, staffed with experienced anaesthesiologists, the~     rate of difficult PHETI (defined as more than one intubation attempt needed to secure a~     patent airway) is lower than 10 %, when using the McGrath MAC VL as primary choice in~     pre-hospital intubations.~   "
117048|NCT02035436|"~     Through many years, the standard care has been to use continuous sedation of critically ill~     patients during mechanical ventilation. However, preliminary randomised clinical trials~     indicate that it is beneficial to reduce the sedation level in these patients. The NONSEDA~     trial is an investigator-initiated, randomised, clinical, parallel-group, multinational,~     superiority trial designed to include 700 patients from at least six ICUs in Denmark, Norway~     and Sweden, comparing no sedation with sedation and a daily wake-up trial during mechanical~     ventilation. This is a substudy of the NONSEDA trial, concerning 250 patients included at~     trialsite Kolding, Denmark. The aim of the substudy is to assess the effects of no sedation~     on delirium during admission and cognitive function after discharge from ICU.~      Our hypothesis is that critically ill patients who are not sedated during mechanical~     ventilation will have better cognitive function after discharge.~   "
117049|NCT02035423|"~     The cluster randomized trial (CITFOMIST) was conducted on 15-19-year old guidance and high~     school students of both genders from different districts of Tehran, the Iranian capital, in~     winter 2011. The 36 schools enrolled in this study were randomly assigned to receive one of~     the three groups of milk -- whole milk, milk that contained 600 IU Vit D/1000cc, milk that~     contained 1000 IU Vit D /1000cc -- for a 30-day period. In order to study the effect of~     vitamin D-fortified milk on the circulating concentrations of 25(OH)D, a serum vitamin D~     levels were checked in a subgroup before and after the intervention.~   "
117050|NCT02035410|"~     Cardiovascular implantable electronic device (CIED) infections have been increasing out of~     proportion to the number of devices implanted We investigated recent trends and possible~     causes of the increasing numbers of Cardiovascular implantable electronic device infections.~   "
117051|NCT02035397|"~     One possible angle for treating obesity could be slowing down the gastric emptying time. By~     prolonging the gastric emptying time, the person would ideally experience increased sensation~     of satiety, and in the long run reduce food intake. If such a treatment provides a clinically~     significant weight loss, this could be an alternative for surgical procedures, avoiding the~     risk for perioperative complications as well as complications in the long run.~      There are now several pilot studies documenting that intragastric treatment with botulinum~     toxin A (BTA) can be effective, although the treatment perspective is short and do not~     include repeated injections. However, they demonstrate that BTA-injections are safe for the~     patient. The treatment is administered by endoscopy.~   "
117052|NCT02035384|"~     This study is conducted in Europe, and North and South America. The aim of this study is to~     provide additional documentation of the immunogenicity, and obtain additional clinical data,~     of turoctocog alfa in the setting of normal clinical practise in patients previously treated~     with a factor VIII agent (FVIII).~   "
117053|NCT02035371|"~     This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetic~     (the exposure of the trial drug in the body) properties of FIAsp (faster-acting insulin~     aspart) in children, adolescents and adults with type 1 diabetes.~   "
117054|NCT02035358|"~     In this Phase 1 Trial investigators plan to establish the MTD of HyperAcute®-Renal (HAR)~     immunotherapy in subjects with clinically metastatic renal cell carcinoma.~   "
117055|NCT02035345|"~     This is a research study to determine if administering carboplatin at a slower rate when~     re-treating recurrent ovarian cancer patients prior to the development of a hypersensitivity~     reaction will decrease the frequency and severity of future hypersensitivity reactions.~   "
117056|NCT02035332|"~     The primary objective of this study is to evaluate the use of the Aurora Ablation System in~     reducing menstrual blood loss at 12 months post-treatment. The occurrence of adverse events~     will be assessed along with an assessment of the reduction of uterine bleeding as measured by~     a pictorial blood loss assessment chart (PBLAC) or menstrual diary.~   "
117057|NCT02035319|"~     In this research study investigators want to learn more about capillary malformations which~     are also known as port wine stains.~      Investigators are asking children with capillary malformations (port wine stains) to be in~     the research, because investigators do not have a good idea of what to expect from the~     current treatments of these malformations. These malformations are treated with laser as~     clinically indicated and there are no standardized methods to assess improvement.~   "
117058|NCT02035306|"~     To answer the question whether a non-invasive haemaglobin measurement is clinically useful,~     reliable and accurate as compared to taking a blood sample and checking the haemaglobin level~     at the laboratory or in a blood gas analyser. This study will take place in a~     multi-disciplinary ICU of critically ill patients.~   "
117059|NCT02035293|"~     A standardized diagnostic strategy of pulmonary embolism will be applied to eligible~     patients, incorporating a clinical probability score (revised Geneva score), plasma D-dimer~     assay and if necessary, a multidetector-row CT angiography thoracic and venous ultrasound of~     the lower limbs. All the patient with a pulmonary embolism diagnosed or not, will be followed~     for 3 months.~   "
117060|NCT02035280|"~     As the population continues to age, the prevalence of spinal deformity surgery for older~     patients is increasing. Questions regarding the suitability of these patients to undergo~     large spinal procedures and whether the outcomes merit the risks involved are not well known.~   "
117061|NCT02035267|"~     The objectives of this study are to explore the safety and efficacy of subcutaneous~     injections of ATX-101 relative to placebo, in the submental area.~   "
117064|NCT02035228|"~     The purpose of this study is to determine whether transcutaneous electrical stimulation~     applied to the abdominal wall muscles synchronous with voluntary exhalation can be used to~     reduce hyperinflation in patients with chronic obstructive pulmonary disease.~   "
117066|NCT02035202|"~     The purpose of this study is to evaluate the effectiveness of a mobile real-time cognitive~     behavioral intervention for serious mental illness (SMI) and to identify the facilitators,~     barriers, and costs of implementation. We would like to determine whether the addition of a~     mobile phone monitoring software program to a brief behavioral intervention for bipolar~     disorder or schizophrenia improves symptoms arising from the disorders. In this study we will~     be assessing the feasibility, acceptability and short term effect of the mobile phone~     enhanced intervention for bipolar disorder and schizophrenia.~   "
117067|NCT02035189|"~     An observational study in evaluating the clinical impact of procalcitonin on the care of Stem~     cell transplant recipient and its performance as an adjunct in the diagnosis and~     prognostication of Infectious processes~   "
117068|NCT02035176|"~     Autism Spectrum Disorders (ASD) feature impairments in social interaction and communication.~     Drug and behavioral treatments for ASD are undergoing rapid development, yet our diagnostic~     tools are not suitable for efficacy assessment. The Autism-Diagnosis Observational Schedule~     (ADOS) is a clinical interview with the child and the gold standard for diagnosis. However,~     this test is subjective, course grained and costly, precluding repeated tests of the same~     child to assess treatment efficacy and large-scale control assessments of typically~     developing (TD) children. For these reasons, the ADOS can impede imaging and genetic~     research.~      In light of these concerns, the Oregon Animation Test for Social Reciprocity (OATS) will be~     developed to evaluate distinct autistic behavioral phenotypes, including joint attention,~     empathy, imitation, and lack of narrative coherence. The main idea of OATS is that animated~     characters and social scenarios are presented on a computer screen while the responses of the~     child are recorded by video camera, microphone, and eye-tracking equipment. Animations are~     used to test each behavioral phenotype of autism. The long-term vision for OATS is to~     evaluate behavioral and physiological responses of autistic children, including heart rate~     variability, pupil dilation, and EEG. Our first objective is to use existing animations to~     build an OATS Prototype that discriminates autistic from normal children (Aim 1). From~     these results, and use of a defined library of still frame posed images, we will design our~     own animation platform to assess differences between autistic and normal children (Aim 2).~   "
117069|NCT02035163|"~     Atrial fibrillation after coronary artery bypass graft is a common complication.~      The investigators have thought that the mechanism of temporarily postoperative atrial~     fibrillation is closely related to the autonomic nervous system imbalance.~      In a last several years, cryoablation was substituted for atrial incision in many reports to~     simplify the maze procedure.~      However, there has been no comparative study to delineate the feasibility of the use of~     cryoablation.~   "
117070|NCT02035150|"~     Regular breakfast consumption may help lower body weight reduce body fatness and improve~     cardiovascular disease risk factors. However, the best kind of breakfast to consume to~     achieve these effects is unclear. We hypothesized that a high fiber breakfast would suppress~     appetite, lower body weight and improve cardiovascular disease risk factors compared with a~     no-fiber breakfast.~   "
117071|NCT02035137|"~     This study will compare three treatment regimens containing metaiodobenzylguanidine (MIBG)~     and compare their effects on tumor response and associated side effects, to determine if one~     therapy is better than the other for people diagnosed with relapsed or persistent~     neuroblastoma.~   "
117072|NCT02035124|"~     Although there have been advances in the treatment of patients with metastatic~     castrate-resistant prostate cancer (mCRPC), all patients eventually develop resistance to~     available therapy. Docetaxel is the accepted first-line agent followed by cabazitaxel in the~     post-docetaxel phase. In this study the investigators propose to evaluate BKM120, a PI3K~     inhibitor, with cabazitaxel in the treatment of patients with advanced prostate cancer.~   "
117073|NCT02035111|"~     The purpose of this study is to evaluate the safety and the efficacy of Tianshu capsule~     treating Migraine Headache.~   "
117074|NCT02035098|"~     The objective of the study is to evaluate the efficacy of the Pac-IFicO programme in~     improving the quality of pain management in hospitalised cancer patients. This is a~     before-after cluster phase II study performed in medicine, oncology and respiratory disease~     hospital wards. The Pac-IFicO programme is a complex interventions with multiple components.~     The primary end-point of the study is the proportion of cancer patients with severe pain.~   "
117075|NCT02035085|"~     Six female patients (>18 years of age, pre-menopausal) who have had loco-regional (lumpectomy~     and radiation) therapy for breast carcinoma and have been at least one-year disease free will~     undergo liposuction, the autologous SVF cell fraction will be isolated and labeled with~     CS-1000 in the operating room without entering cell culture, which will then be returned to~     the patient at the site of breast grafting. Patients will receive a pre-screening MRI .~     Patients will have an MRI scans over a period of 1 month at Johns Hopkins. Follow-up MRIs at~     6,12, and 18 months will also be performed. Only at Johns Hopkins with fluorine being done as~     part of this investigational study. By performing fluorine MRI and quantification of 19F~     signal, we hypothesize that the engraftment of transplanted cells can be tracked in ways not~     possible before, using the total fluorine signal as surrogate marker for cell persistence and~     survival. We expect that a clinically successful outcome (maintenance of breast contour and~     volume) will be positively correlated with cell survival. The outcome of this study may pave~     the way for using 19F MRI cell tracking as a new tool for stem cell therapy in a variety of~     clinical applications.~   "
117087|NCT02034929|"~     The EndoCuff is novel flexible cuff that can be attached to the distal tip of the colonoscope~     and helps to flatten large mucosal folds during withdrawal.~      The study hypothesis is that the use of the Endocuff (EC) increases the adenoma detection~     rate during colonoscopy.~      The study purpose is to compare EC-assisted colonoscopy with standard colonoscopy for polyp~     detection.~   "
117088|NCT02034916|"~     The purpose of this 2-stage, 2-cohort Phase 2 trial is to evaluate the safety and efficacy of~     talazoparib (also known as BMN 673) in subjects with locally advanced or metastatic breast~     cancer with a deleterious germline BRCA 1 or BRCA 2 mutation. Subjects will be assigned to~     either Cohort 1 or 2 based on prior chemotherapy for metastatic disease:~        -  Cohort 1) Subjects with a documented PR or CR to a prior platinum-containing regimen for~          metastatic disease with disease progression > 8 weeks following the last dose of~          platinum; or~        -  Cohort 2) Subjects who have received > 2 prior chemotherapy regimens for metastatic~          disease and who have had no prior platinum therapy for metastatic disease~   "
117076|NCT02035072|"~     Title: Phase II study of hypofractionated radio-chemotherapy with gemcitabine plus~     oxaliplatin for unresectable nonmetastatic locally advanced pancreatic cancer.~      Protocol code: IRST157.01~      Phase: II~      Study Design: monocentric, prospective, open-label not randomized trial.~      Description of Study Treatment: radio-chemotherapy schedule~        -  GEMOX: Gemcitabine (GEM) 1000 mg/m2, day 1, and Oxaliplatin (OX) 100 mg/m2, day 2, every~          2 weeks for 4 cycles.~        -  Hypofractionated radiotherapy (35 Gy in 7 fractions in 9 consecutive days, one session~          per day excluding Saturday and Sunday) administered 15 days after the 4th chemotherapy~          cycle.~        -  Further 4 cycles of GEMOX, starting 7-15 days after the end of the radiotherapy.~      Objectives:~      Step A: primary objective = to evaluate the safety of radiotherapy treatment. Secondary~     objective = the control of IM (internal margin) intra-fraction.~      Step B: primary objective = to evaluate the proportion of the resectable patients after~     radio-chemotherapy. Secondary objectives = overall Response Rate (ORR); safety profile of~     combinated treatment;overall survival (OS); local progression free survival (LPFS) and~     progression free survival (PFS).~      Statistical Considerations:~      Step A:~      Assuming that the probability to observe a toxicity involving the radiotherapy treatment~     discontinuation with the new treatment is less than 20%, 11 patients are to be evaluated for~     toxicity. If no toxicity involving the radiotherapy treatment discontinuation will be~     observed in 11 patients, the treatment can be considered safe with a probability > 90%. If 1~     toxicity involving the radiotherapy treatment discontinuation will be observed, 7 more~     patients needs to be recruited. If no further toxicity involving the radiotherapy treatment~     discontinuation occurs, the treatment could be considered safe with a probability ≥ 90%.~      If 2 or more toxicity involving the radiotherapy treatment discontinuation on 11 patients or~     2 or more toxicity involving the radiotherapy treatment discontinuation on 18 patients will~     be observed, the study will be stopped because not safe and another kind of radiotherapy~     schedule must be designed.~      Step B:~      If the radiotherapy treatment will be considered no toxic, the study will continue in Step B~     : the goal of this phase II study is to increase the proportion of resectable patients of at~     least 15% with the new radio-chemotherapeutic treatment. By using the single-stage design~     (Gehan EA, J Chron Dis 1961) a total of 40 patients is required to be recruited in 2 years,~     and a further one-year period of follow-up is requested. If at least 7 patients out of 40~     enrolled will be resectable, the hypothesis that the proportion of resectable patients will~     be less or equal to P1 (P1=the proportion of resectable patients with the new~     radio-chemotherapeutic treatment) will be refused and the treatment could be considered~     active.~   "
117077|NCT02035059|"~     The objective of the study is, if an early oral glucose tolerance test combined with maternal~     history, condition and multiple biomarker analysis can be used to detect gestational diabetes~     mellitus in the first trimester (12-14 weeks of gestation).~   "
117078|NCT02035046|"~     Gitelman syndrome is a salt wasting tubulopathy caused by mutations in the SLC12A3 gene~     coding for the thiazide sensitive sodium chloride cotransporter. This disease mimics the~     chronic treatment with thiazide diuretics and is characterized by renal hypokalemia, low to~     normal blood pressure, hypocalciuria and hypomagnesemia. The purpose of this study is to~     determine whether the heterozygous carriers present the metabolic risks and/or the benefits~     of this disease.~   "
117079|NCT02035033|"~     Osteoporosis (op) is a disorder of bone characterized by reduced mineral density and bone~     mass. The first step in the prevention and treatment of Op is ensuring adequate intake of~     calcium and vitamin D . While calcium supplementations clearly slow bone loss in both~     sexes,their effects on fracture risk are less certain. In contrast to the above a recent~     randomized, placebo controlled trial in 1471 postmenopausal women (mean age 74) reported in~     the BMJ (2 February 2008) found an increased rate of vascular events in healthy older women~     receiving calcium supplementation. The mechanism is not clear .we are trying to identify a~     possible correlation between calcium intake and calcium cardiac scoring .~   "
117080|NCT02035020|"~     The primary objective of this study is to investigate whether the treatment with IFN gamma~     can induce significant accumulation of frataxin in FRDA patients, a possibility suggested by~     pre-clinical evidence in an animal model of the disease.~   "
117081|NCT02035007|"~     The purpose of this study is to examine the validation of the PiCCO (Pulse Contour Cardiac~     Output)-derived transpulmonary thermodilution technology in patients with heart diseases.~   "
117082|NCT02034994|"~     The main objective is to evaluate the effects of a multicomponent, school-based intervention~     combining change in nutritional behaviors with after school physical activity activities in~     reducing the excessive weight gain in schoolchildren.~   "
117083|NCT02034981|"~     This is a biology driven, trans-tumoral, multicentric phase II trial assessing the efficacy~     and the safety of the targeted agent crizotinib as a monotherapy in 23 cohorts of patients~     with identified activating molecular alterations in the crizotinib target genes. A cohort is~     defined by a pathology and a crizotinib-target alteration (eg gastric cancer with MET~     amplification).~      For each cohort a two-stage design will be implemented. In the situation where expected~     accrual allows for a sufficient number of patients to be accrued, the alpha and beta errors~     will be fixed at 10%. However, in very rare diseases, such as inflammatory myofibroblastic~     tumor (IMT), neuroblastoma, glioblastoma, and rhabdomyosarcoma (RMS), it is anticipated that~     the target number may not be achievable in a reasonable timeframe; for these cohorts, the~     alpha and beta errors will be fixed at 15%. Consequently three different statistical designs~     will be a priori considered according to the expected response rate and incidence.~   "
117084|NCT02034968|"~     There have been reports suggesting that anti-epidermal growth factor antibody nimotuzumab is~     advantageous for advanced esophageal cancer patients in combination with chemotherapy or~     radiotherapy.And,albumin-bound paclitaxel was characterized with high tolerated doses with~     greater efficacy,and with greater concentration in tumor tissue compared with normal~     tissues.So,The objective of this single-arm phase II trial was to evaluate the benefit of~     nimotuzumab plus nab-paclitaxel and cisplatin in patients with advanced esophageal carcinoma.~   "
117085|NCT02034955|"~     This study will ultimately aim to evaluate the side effects of treatment by asking 20~     subjects to receive post-operative radiotherapy for prostate cancer with the treatment plan~     adapted after the first week of treatment to account for changes in the target shape. These~     patients will be asked to complete toxicity scores and a quality of life questionnaire at the~     start and completion of treatment, and at 3 months 1, 2 and 5 years from the start of~     radiotherapy. These results will be used to determine the feasibility of the proposed~     approach, and obtain early estimates of improvements in uncertainty margin requirements for~     this population of patients.~   "
117086|NCT02034942|"~     Critically ill, ventilator-treated patients rapidly loose much of their muscle mass and~     strength. This can attribute to prolonged admission, prolonged mechanical ventilation,~     increased mortality and might have a negative impact on the physical function, degree of~     independence and quality of life. The pathophysiological background for the loss of muscle~     mass as well as possible effective treatment is still not well established. In the~     NONSEDA-trial we randomise critically ill patients to non-sedation or sedation with a daily~     wake-up trial during mechanical ventilation in the intensive care unit (ICU). It has never~     been assessed whether non-sedation reduces the loss of muscle mass and strength.~      Aim: To assess the effects of non-sedation versus sedation with a daily wake-up trial on~     physical function after discharge from ICU.~      Hypothesis: that non-sedation during ventilator-treatment will improve the physical function~     after ICU-discharge, compared with standard treatment of sedation with a daily wake-up.~   "
117110|NCT02034630|"~     To evaluate the outcome of hematopoietic stem cell transplantation using targeted busulfan,~     fludarabine conditioning regimen in genetic rare disease~   "
117089|NCT02034903|"~     The temperature of milk fed to infants in the Neonatal Intensive Care Unit (NICU) has been~     shown to vary greatly, and is influenced by individual provider practice. The clinical effect~     of varying milk temperatures on preterm infant feeding tolerance has not been well studied.~     The purpose of this study is to examine the effect of warming method, water bath versus~     commercial warmer and its impact on feeding tolerance. Sample population will include~     eighty-six infants born at 30-0/7 weeks or less, and admitted to the Neonatal Intensive Care~     Unit at Advocate Children's Hospital, Park Ridge within 48 hours of birth and remain in the~     study for a minimum of 28 days. After obtaining consent, eligible infants will be assigned to~     a control (water bath) or experimental (commercial warmer) group using a randomized sampling~     scheme. After warming, and just prior to feeding, milk temperatures will be taken and~     recorded by a trained data recorder. Feeding tolerance will be measured based on gastric~     residual volume and length of time required to achieve full feeds. Based upon the available~     evidence, the study investigators hypothesize that warming feeds to a consistent temperature~     range using commercially available milk warmer will improve feeding tolerance and decrease~     time to full feedings in preterm infants.~   "
117090|NCT02034890|"~     Prospective trial which includes instillation of intravesical hyaluronic acid in an attempt~     to reduce the incidence of urinary tract infections in patients after orthotopic neobladder~     reconstruction.~   "
117091|NCT02034877|"~     This study is to describe the safety and immunogenicity of 13vPnC in Indian adults 50 to 65~     years of age and in Indian children 6 to 17 years of age.~   "
117092|NCT02034864|"~     The purpose of this study is to determine whether a standardised osteopathic manipulative~     treatment is more effective than a placebo of osteopathic manipulative treatment, in~     sub-acute and chronic non-specific low back pain on functional recovery at 3 months.~   "
117093|NCT02034851|"~     Hypothesis: Administration of corticoids (dexamethasone) together with the conventional~     antibiotherapy in the acute phase of a febrile urinary tract infection could reduce the risk~     of renal scarring after 6 months of the primo-infection.~      Primary objectives:To evaluate the reduction in incidence of renal scarring after 6 months of~     a acute pyelonephritis between the control group (conventional therapy plus placebo) and~     intervention group (conventional therapy plus dexamethasone.~      Design: Multicentre randomized clinical trial,placebo controled, including children between 2~     months and 14 years with a acute pyelonephritis proven by a acute phase DMSA~     (dimethylsuccinic acid ). A total of 180 children in to parallel groups (intervention and~     placebo) will be included.~   "
117094|NCT02034838|"~     This is an open-label, single group study to determine the pharmacokinetic profile of~     atazanavir 300 mg daily boosted with ritonavir 100mg daily in HIV-infected patients over a~     period of 9 days.~      Ritonavir and atazanavir are protease inhibitors used to treat HIV. However, ritonavir, when~     used at low doses (up to 100mg) does not have HIV activity, but will enhance (boost) the~     blood concentrations of other drugs like atazanavir.~      Recently, a study showed that taking 50mg of ritonavir administered in an oral solution led~     to similar blood concentrations of atazanavir than when given with 100mg of ritonavir.~     Potential benefits associated with a lower dose of ritonavir may include a reduction of side~     effects such as upset stomach and an improvement in cholesterol level. This study will look~     at the amount of atazanavir into your blood when given with ritonavir in a tablet formulation~     at 50mg or 100mg with standard atazanavir dose (300mg).~   "
117095|NCT02034825|"~     This prospectively designed retrospective clinical utility study will evaluate urologists'~     treatment recommendations before and after reviewing Decipher results for selected patient~     cases.~   "
117096|NCT02034812|"~     This clinical utility study is based on a review of real but de-identified and randomized~     patient cases and aims to evaluate radiation oncologist's treatment recommendations before~     and after reviewing the results provided by the Decipher test. The primary intent is to help~     guide development and design of future clinical utility studies for Decipher.~   "
117097|NCT02034799|"~     The objective of this study is to observe the clinical utility and performance of Bioseal~     when used as an adjunct to hemostasis versus Standard of Care (SoC) in elective meningioma~     surgery.~   "
117098|NCT02034786|"~     Lipodystrophies are part of a clinically heterogeneous group of disorders characterized by~     loss (lipoatrophies) and / or accumulation of fat, which usually results in a change of~     normal tissue surface. Millions of plastic and reconstructive surgeries are performed~     annually to repair soft tissue defects due to trauma, tumor resection and congenital defects.~     Surgical options for lipoatrophy, the lipodystrophy type characterized by subcutaneous~     adipose tissue atrophy, include: Transfer of autologous fat, Dermis - fat graft, Skin flaps~     and Commercially available fillers.~      Currently, the most commonly filler agent used for the lipodystrophy treatment is~     polymethylmethacrylate, considered permanent and with a history of short- and medium-term~     adverse effects. Biocompatible and temporary filler agents such as hyaluronic acid,~     polylactic acid and collagen have been used for over 25 years for cosmetic purposes and in~     lipoatrophies. More recently, the use of autologous fibroblasts proved to be efficient~     solving acne scars and enabling dermis regeneration. Studies in mice showed that the~     combination of pre - adipocytes with a biomaterial is much more effective in tissue~     reconstitution than the injection of adipose tissue only, providing volume and also~     stimulating cell proliferation and differentiation with increased production of extracellular~     matrix.~      This project aims a phase I clinical trial of a filler agent, composed of mesenchymal stem~     cells derived from autologous adipose tissue associated with hyaluronic acid.~   "
117099|NCT02034773|"~     To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses~     of CC-220 in healthy subjects and to evaluate the relative bioavailability of a formulated~     CC-220 capsule~   "
117121|NCT02034487|"~     To evaluate the phenotype and biochemical characteristics of boys referred for delayed~     puberty, to describe the frequency of associated co-morbidities and diseases, to evaluate the~     diagnostic criteria and the effect of testosterone treatment.~   "
117122|NCT02034474|"~     Randomized, double-blind clinical trial of tocilizumab vs. placebo as add-on treatment for~     residual positive, negative, and cognitive symptoms in schizophrenia. The primary study~     hypothesis is that individuals receiving tocilizumab will show greater improvements in their~     PANSS total scores than those taking placebo.~   "
117100|NCT02034760|"~     Up to approximately 205 (dependent on drop-out rate) healthy elderly individuals (at least 65~     years old) are recruited as subjects.~      Upon inclusion, each individual will be randomized into one of the five groups stratified~     according to gender (M/F) and 30s chair stand (<16 OR ≥16). The five groups are: Heavy~     Resistance Training (N=30-35), Light Intensity Training (N=30-35), Protein Whey (N=40-50),~     Protein Collagen (N=40-50) and Carbohydrate (N=30-35). The individuals randomized into one of~     the supplementation groups (Protein Whey, Protein Collagen or Carbohydrate) will be blinded~     to the supplement content.~      Assessments will be performed at Baseline (before intervention start), and after 6 and 12~     months of intervention and again at 18 months (after 6 months of follow up).~      The primary outcome is change in quadriceps muscle cross sectional area from Baseline to 12~     months of intervention.~      The primary hypothesis is that by applying the intension-to-treat analysis, the Light~     Intensity Training group will increase quadriceps muscle cross sectional area just as much as~     the Heavy Resistance Training group. The two training groups will gain more muscle mass than~     the Protein Whey group, which will gain more than the Protein Collagen and the Carbohydrate~     groups that will loose quadriceps muscle cross sectional areas.~   "
117101|NCT02034747|"~     This study is a multicenter, randomized, comparison, open-label, phase IV study in kidney~     transplant recipients whose immunosuppressive regimen is converted from Cyclosporine with~     corticosteroid to Advagraf® with corticosteroid. The eligible patients will be randomized~     into either Arm 1 or Arm 2. The Arm 1 will be reduced corticosteroid slowly until 50% lower~     dose from 4 weeks to 12 weeks in the Advagraf®-based immunosuppressive regimen, and the Arm 2~     will receive the same corticosteroid dose for 24 weeks with Advagraf ®.~   "
117102|NCT02034734|"~     The purpose of this study is to evaluate the plasma and cerebrospinal fluid (CSF)~     pharmacokinetics (PK) of multiple doses of ASP3652 in healthy young Caucasian male subjects.~     Also to evaluate the plasma and CSF pharmacodynamics (PD) of multiple doses of ASP3652 in~     healthy young Caucasian male subjects and to assess the safety and tolerability of multiple~     doses of ASP3652 in healthy young Caucasian male subjects.~   "
117103|NCT02034721|"~     Intense, eccentric resistance exercise causes muscle damage, soreness, inflammation, and a~     loss of muscle function. Protein-amino acid supplementation before, during, and following~     damaging resistance exercise may reduce muscle damage and accelerate recovery. This study~     will determine if supplementation with Herbalife 24 Rebuild Strength (compared to placebo)~     before, during, and after a 90-minute bout of eccentric exercise attenuates exercise-induced~     muscle damage, inflammation, and delayed onset of muscle soreness (DOMS), speeds recovery of~     muscle function, and maintains immune function in NASCAR pit crew athletes (Hendrick Motor~     Sports).~   "
117104|NCT02034708|"~     The purpose of this study is to demonstrate non-inferiority of Dotarem®-enhanced MRI as~     compared to Gadovist®/ Gadavist®-enhanced MRI in the diagnosis of brain tumors in terms of~     overall lesion visualization and characterization (off-site assessment).~      270 patients will be randomized between 2 arms defining the sequence of administration of the~     contrast agents at the dose of 0.1mmol/kg, with a minimum of 48 hours and a maximum of 14~     days in between.~      Each patient will, therefore, receive two MRI during his/her participation in the study.~      The two arms consist in :~        -  Dotarem® in the first MRI, then Gadovist®/Gadavist® in the second MRI.~        -  Gadovist®/Gadavist® in the first MRI, then Dotarem® in the second MRI.~      Contrast-enhanced MRIs will be performed on 1.5 or 3 Tesla systems.~      MRI examinations will be evaluated centrally by blinded independent readers for the main~     evaluation criterion.~   "
117105|NCT02034695|"~     Diabetes mellitus (DM) is one of the major cause of morbidity and among the top 10 causes of~     deaths in Hong Kong in 2008 (Department of Health 2009). The Hospital Authority (HA) has~     initiated service improvement through introducing the risk assessment and management~     programme (RAMP) to improve the quality of care (QOC) for DM patients in general outpatient~     clinics (GOPC). The evaluation on the QOC is an essential part of the programme in order to~     inform future policy. The Department of Family Medicine and Primary Care (FMPC) of the~     University of Hong Kong (HKU) has been appointed by the HA to carry out the evaluation of the~     QOC of the programme.~      The Action Learning and Audit Spiral methodologies to measure whether the target standard of~     care intended by the RAMP programme is achieved. Each RAMP participating clinic and hospital~     will be invited to complete a structured evaluation questionnaire. The data of all patients~     who have enrolled into the RAMP for more than one year will be included in the evaluation on~     the process and outcomes of care.~      One thousand two hundred and forty-eight age and disease matched control patients who have~     not been enrolled into the RAMP programme will be selected for the comparison in the outcomes~     of care. A hundred and thirty participants will be followed up by telephone to evaluate the~     effect of the programme in quality of life (QOL), patient enablement, and global rating of~     change in health condition at baseline and 6 months after enrolment. Data on the process of~     care will be retrieved from the HA medical records.~      Main Outcome Measures: The primary outcomes are the proportion of participants who have~     received the criterion process of care, and achieved the target HbA1c and blood pressure~     levels.~      Data Analysis: Descriptive statistics on proportions of centers or subjects meeting the QOC~     criteria will be calculated. The changes in the clinical and patient reported outcomes of~     RAMP subjects will be compared at 12, 24, 36 and 48 months will be compared by paired sample~     t-test. The clinical outcomes between RAMP subjects and control group will be compared by~     independent sample t-test or Chi-square test.~      Results: The QOC of the RAMP programme will be determined. Areas of deficiency and possible~     areas for quality enhancement will be identified.~      Conclusion: The results of this study will provide empirical evidence on whether the HA's~     RAMP programme can achieve improvement in QOC for DM patients. The information will be used~     to guide service planning and policy decision making.~   "
117106|NCT02034682|"~     The aim of this study is to compare 6% hydroxyethyl starch (HES) 130/0.4 in a balanced~     electrolyte solution (Volulyte®) with modified fluid gelatin (Geloplasma®) as the priming~     solution for the cardiopulmonary bypass (CPB) circuit. The microvascular reactivity and the~     effects on tissue (StO2) and cerebral (ScO2) oxygen saturation will be examined using~     near-infrared spectroscopy (NIRS).~   "
117107|NCT02034669|"~     This study is designed to assess the safety and effect of autologous adipose derived stem~     cell (ADSCs) transplantation in acute spinal cord injury patients.~        1. To assess the safety of autologous ADSCs transplantation in acute spinal cord injury and~          the complication after ADSCs transplantation.~        2. To evaluate the effect of ADSCs isolation and expansion procedure.~        3. To determine if functional outcome is improved following ADSCs transplantation in acute~          spinal cord injury patient, using pre-transplantation spinal cord function as the~          control.~   "
117108|NCT02034656|"~     The purposes of this study are to investigate the patterns of BCR-ABL mutations in CML and Ph~     positive ALL patients with imatinib resistance during the year of 2001-2009 in Asian~     institutes.~   "
117109|NCT02034643|"~     Tracheal cuff overinflation is known to reduce tracheal mucosal blood flow and to increase~     tracheal morbidity. Transesophageal echocardiography (TEE) probe insertion may increase the~     tracheal cuff pressure. The aim of this study is to evaluate the effect of TEE probe~     insertion on tracheal cuff pressure and to compare the effects in single-lumen tube and~     double-lumen tube.~   "
117111|NCT02034617|"~     When becoming a parent of a preterm infant there is an increased risk of stress. There are a~     number of studies showing that parental stress has a negative impact on their engagement with~     their child. Other studies, on the other hand, show that different intervention programs with~     the aim to strengthen the relationship can decrease parental stress and hence affect the~     parent-infant interaction in a positive way. Structured intervention programs for preterm~     infants have also been successful in improving the infants' cognitive functions.~      The investigators have developed a program with the aim to strengthen the parent-infant~     interaction for late preterm infants. The observational program is called LiMoNid. Our~     hypothesis is that LiMoNid will strengthen the parents' own parental abilities and give them~     a deeper understanding of their child. They will hopefully develop more skills on how to~     communicate with their child; to see, interpret, understand and approach the child, which can~     lead to an improved parent-child interaction. Parental stress may also be reduced by~     increased understanding and control. Regarding the child itself, we hypothesize that the~     psychological development will be affected depending on the communication with the caregiver~     and depending on the support it has received in expressing its feelings and needs. The~     emotional regulation should be strengthened by such an intervention.~      The aim is to study if LiMoNid can have an impact on cognition, stress, parent-child~     interaction.~   "
117112|NCT02034604|"~     This study is designed to evaluate efficacy and safety of naftopidil in patient with~     neurogenic lower urinary tract dysfunction not caused by benign prostatic hyperplasia.~   "
117113|NCT02034591|"~     The purpose of this study is to assess the bioavailability of Apixaban oral solution~     administered through an Nasogastric Tube (NGT) in the presence of Boost® Plus and Apixaban~     administered as crushed tablet through a nasogastric tube relative to Apixaban solution~     administered orally in healthy subjects.~   "
117114|NCT02034578|"~     The purpose of this study is to assess the bioavailability of Apixaban solution administered~     through NGT and washed with Dextrose 5% in water (D5W) or infant formula relative to Apixaban~     solution administered orally in healthy subjects~   "
117115|NCT02034565|"~     The purpose of this study is to assess the oral bioavailability of Apixaban solution~     formulation (Treatment B, 10 mg as 25 mL x 0.4 mg/mL) relative to Apixaban tablets (Treatment~     A, 10 mg as 2 x 5 mg tablets) in healthy subjects.~   "
117116|NCT02034552|"~     The primary objective in this study is to evaluate bone scan response at Week 24 based on the~     quantified technetium-99 bone scan lesion area (BSLA). The safety of radium-223 dichloride in~     combination with abiraterone acetate or enzalutamide will be investigated. The study will~     evaluate radiological progression free survival, overall survival, and skeletal events. This~     study will also explore the clinical utility of different imaging modalities (whole body~     quantified technetium-99 bone scan, DW-MRI and NaF PET-CT scan) and will have a separate~     central radiological review for applicable secondary and exploratory imaging endpoints. All~     subjects will be randomized as assigned randomly by the IXRS system in a 1:1:1 ratio into one~     of the treatment arms: radium-223 dichloride alone, 50 kBq/kg (55 kBq/kg after implementation~     of NIST update) every 4 weeks for up to 6 doses; radium-223 dichloride, 50 kBq/kg (55 kBq/kg~     after implementation of NIST update) every 4 weeks up to 6 doses together with abiraterone~     acetate 1,000 mg daily and prednisone 5 mg bid; radium-223 dichloride 50 kBq/kg (55 kBq/kg~     after implementation of NIST update) every 4 weeks up to 6 doses together with enzalutamide~     160 mg daily.The study will consist of screening, treatment and follow-up periods. Study will~     continue until disease progression as determined by investigator, or when patient meets~     criteria for withdrawal from study. Subjects in treatment arms with abiraterone/prednisone or~     enzalutamide will have the option to continue taking oral study therapy until the end of the~     study (2 years from the last dose of radium-223 dichloride) if the investigator deems the~     subject may benefit and there is no clinical or radiological progression. Subjects who~     discontinue all study treatment prior to 2 years from last radium-223 dichloride treatment~     will enter active follow-up. During the active follow-up period, the subject will have a~     safety visit at the clinic every 12 weeks from the EOT for up to 2 years from the last dose~     of radium-223 dichloride. Beyond 2 years from last radium-223 dichloride treatment,subjects~     will enter long-term follow-up and will be followed via phone contact at intervals to assess~     for safety (hematological toxicity and new primary malignancies) and overall survival. A~     separate long-term safety follow-up study protocol is planned. Once implemented, the study~     subjects surviving after the end of the active follow-up will be transitioned to this~     separate long-term safety follow-up protocol.~   "
117117|NCT02034539|"~     In patients with critical limb ischemia (CLI) and foot ulcers wound healing is an important~     goal which can normally only be achieved after sufficient treatment of the underlying~     ischemia (revascularization either by an operation, e. g. bypass, or a catheter~     intervention). After successful revascularization everything should be done to improve wound~     healing because this regularly takes weeks up to several months. One possibility to speed up~     healing could be treatment with the VADOplex device which delivers an automatic intermittent~     painless compression of the sole of the foot thereby increasing perfusion of the leg. This~     system can be easily operated by patients themselves and at home.~      Our goal is to prove that the VADOPlex system accelerates healing up and improves quality of~     life.~   "
117118|NCT02034526|"~     Atrial fibrillation (AF) is prevalent in patients with sick sinus syndrome (SSS) and~     associated with an increased risk of stroke and death. Within the first two years after~     pacemaker implantation almost half of the patients are diagnosed with AF. Studies have~     indicated that an increased amount of stimulation from the pacemaker in the atria is~     associated with an increased amount of AF.~      The aim of the present study is to test the hypothesis that a reduction of stimulation from~     the pacemaker in the atria, and reducing the minimal heart rate, increases the time to AF.~   "
117119|NCT02034513|"~     This trial is conducted in Europe and the United States of America (USA). The aim of the~     trial is to compare the safety and efficacy of insulin degludec (IDeg) and insulin glargine~     (IGlar), both with insulin aspart (IAsp) as mealtime insulin in subjects with type 1~     diabetes.~   "
117120|NCT02034500|"~     This Phase 1 clinical trial is aimed to evaluate the safety and immunogenicity of 3 doses of~     a candidate vaccine against Shigella sonnei (1790GAHB vaccine) when administered at different~     dosages by different routes (intradermally, intranasally or intramuscularly) in healthy~     adults (18 to 45 years of age at enrollment). The safety profile of the 1790GAHB vaccine is~     evaluated in comparison to that of placebo (GAHB-Placebo), constituted by an aluminum~     hydroxide suspension having the same concentration as study vaccine formulations. A total of~     52 eligible subjects will be assigned to one of three sequential cohorts as follows:~      Cohort A) 0.1 μg ID and 5 μg IN Cohort B) 1 μg ID and 20 μg IN Cohort C) 10 μg ID, 80 μg IN~     and 5 μg IM Within each cohort, in an observer-blind fashion, subjects will be randomized to~     receive three vaccinations, four weeks apart, of either 1790GAHB vaccine (at five antigen~     concentrations) or GAHB placebo. Specifically for IN and ID administration routes, a Data~     Safety Monitoring Board will be in place to receive a summary of all safety data obtained~     during one week follow-up post-first vaccination with the lower dose. Based on evaluation of~     the safety data, the Data Safety Monitoring Board will make a recommendation, as to whether~     the next cohort should be vaccinated with higher antigen concentration or not.~      Expected duration of the study for an individual subject is 9 months. Each subject will be~     followed-up for 6 months after the 3rd vaccination~   "
117123|NCT02034461|"~     The investigators will study basic physiology of human peripheral nerves using high-count~     microelectrode arrays implanted into peripheral nerves of patients with limb amputations or~     peripheral nerve injury. These microelectrodes will be custom-made and are not available for~     commercial distribution. The investigators hypothesize that recording neural signals from a~     large number of microelectrodes will provide selective motor information in high enough~     numbers to allow control over future artificial devices with many moving parts, i.e.~     artificial limbs with shoulder, elbow, wrist, and/or individual fingers that move. These~     studies will also investigate to what extent microstimulation of nerve fibers can provide~     sensory feedback from a prosthetic limb.~      The investigators will also conduct up to three acute surgeries where a Utah slanted~     Electrode Array (USEA) will be implanted in volunteers who are about to undergo limb~     amputations. These acute implantations will provide Dr. Hutchinson with human surgical~     experience in implanting USEAs and evaluating the containment system we will be using to~     immobilize the implanted USEA in the nerve.~   "
117124|NCT02034448|"~     An observational registry to monitor the outcome of CRRT in adults with acute kidney injury.~   "
117125|NCT02034435|"~     Aim 1.Test the hypothesis that activation of the endogenous renin-angiotensin-aldosterone~     system impairs glycemic control via effects on insulin sensitivity and insulin secretion.~      Aim 2. Test the hypothesis that activation of the endogenous renin-angiotensin-aldosterone~     system impairs insulin secretion and insulin sensitivity via an mineralocorticoid-receptor~     dependent mechanism.~   "
117126|NCT02034422|"~     Hypertension affects 37% of the Veteran population, making it the most common medical~     condition treated by the VA Health Care System. Physical activity is the first line of~     defense in the treatment and management of hypertension. However, individuals with~     hypertension have impaired muscle blood flow and exhibit exaggerated increases in blood~     pressure during exercise (exercise pressor reflex or EPR) leading to exercise intolerance and~     increased risk of stroke and heart attack. The cause of these impairments is not known, but~     it is highly likely that free radical production and the subsequent increase in oxidative~     stress plays a significant role. Two aims are proposed; Aim 1 will identify the physiological~     consequences of elevated oxidative stress in hypertension, and Aim 2 will utilize an~     antioxidant treatment to ameliorate the effects of an exaggerated EPR allowing the safe~     performance of a clinical exercise rehabilitation program which will then, itself, attenuate~     the EPR and reduce hypertension.~   "
117127|NCT02034409|"~     The purpose of this exploratory trial is to investigate whether PLIUS is potentially~     effective as a disease and symptom modifying intervention in patients with early knee OA.~   "
117128|NCT02034396|"~     Currently, there is no standard approach for the treatment of patients with venous stasis~     ulcers, and no means of accounting for the genetic factors that may contribute to a patient's~     response to different therapeutic interventions. In order to determine whether, or to what~     extent, genetic profiling of venous stasis ulcers can stratify patients according to their~     potential for disease progression or healing, and guide preventive strategies and levels of~     therapeutic interventions, the study will involve retrospective genetic profiling of patients~     with a healed or persistent venous stasis ulcer as a means of determining the efficacy of~     current therapies, and to establish a future prospective evaluation of treatment algorithms~     based on genetic phenotype and variation. Results obtained from the 2 aforementioned groups~     of participants will be compared with those of a control group of participants who have no~     history of venous ulcer nor peripheral vascular disease.~   "
117129|NCT02034383|"~     The objective of this study is to measure the effect of processing (roasting, slicing, or~     grinding) on the energy value of almonds in the human diet and study molecular mechanisms~     that may help explain the beneficial health effects of almonds.~   "
117130|NCT02034370|"~     Obstructive Sleep Apnea (OSA) is when a person stops breathing repeatedly during sleep.~     Breathing stops because the airway collapses and prevents air from getting into the~     lungs.This airway closure results in a decrease in the amount of oxygen that is in the blood.~     Anesthetics given during surgery are known to increase the tendency for a patient's airway to~     close immediately after surgery in the recovery room and to reduce the amount of oxygen in a~     patient's blood immediately after surgery. These two factors combined could have a profound~     effect on a patient's well being after surgery.~      Recent advances in general anesthesia, pain medications, and surgical techniques have made~     outpatient surgery more common. Due to the increase in outpatient surgeries, pain management~     techniques that will work efficiently and for longer periods of time are necessary. One of~     these techniques is a nerve block, which coats the nerve with a numbing medication and blocks~     all pain from that area. Nerve blocks are routinely used along with general anesthesia for~     outpatient surgeries and help reduce or eliminate the need for IV or oral pain medicine after~     the surgery. Nerve blocks can provide good pain relief with early recovery and fewer side~     effects (nausea, vomiting, etc.) related to narcotic pain medicines.~      Unfortunately, there are no studies that look at the effect of anesthesia and nerve blocks on~     breathing patterns and oxygen saturation levels after discharge from outpatient surgery. We~     therefore propose to study the changes in lung function tests and blood oxygen levels after a~     nerve block and general anesthesia for outpatient shoulder surgery. We would like to conduct~     a home sleep study including measuring oxygen levels while subjects are sleeping, before,~     during and after surgery, and test lung function both before and after surgery to see if~     there are any differences.~      We will recruit 10 subjects with eligibility based on clinically indicated shoulder surgery~     and a nerve block. The study will be non-interventional during surgery.~      It is possible that future screening for out-patient shoulder surgery includes preoperative~     overnight oxygen saturation measurement to identify patients at high-risk of changes in~     oxygen levels. These patients may benefit from hospital admission after surgery for close~     observation. Thus, this study could have significant implications for patient safety and~     resource utilization.~   "
117131|NCT02034357|"~     The purpose of this study is to determine the impact of sleep and breathing problems during~     sleep on memory, attention, and general well being (quality of life) in people with Parkinson~     Disease.~   "
117132|NCT02034344|"~     The purpose of this study is to obtain skin, blood, and urine samples from patients with~     active cutaneous lupus lesions and from healthy participants.~   "
117145|NCT02034175|"~     The purpose of this study is to evaluate the accuracy of Somnarus diagnostic technology for~     diagnosis of sleep apnea in human subjects. This includes evaluation of Somnarus technology~     in Obstructive Sleep Apnea (OSA) and Central Sleep Apnea (CSA), including Cheyne - Stokes~     respiration (CSR).~   "
117146|NCT02034162|"~     The purpose of this study is to evaluate the efficacy and safety of mebendazole compared with~     placebo in pediatric participants with Helminth infections.~   "
117147|NCT02034149|"~     This study is being implemented for 3 aims. The first has been to conduct a systematic~     literatures review on CKD intervention models and their effectiveness. Findings have been~     adopted in our intervention program. The second purpose is to establish a practical~     management model or an intervention model for CKD patients and high risk population with the~     18-month of follow-up.In the third year, we will use social perspective point to evaluate the~     costs and the benefits of intervention.~   "
117133|NCT02034331|"~     Persons with spinal cord injury (SCI) are at an increased risk for metabolic disorders,~     including that of insulin resistance. As a result of neurological injury, they often have~     impaired mechanisms that regulate blood vessel function below the level of injury. Insulin,~     which facilitates the transport of glucose into muscle cells, is also capable of regulating~     skin blood flow, with insulin resistance reducing perfusion. Although beyond the scope of~     this proposal, the possibility exists that impaired microvascular skin blood flow responses~     due to insulin may further predispose to ischemia of the skin at pressure points of bony~     prominence. This perturbed cutaneous vascular response may place persons with SCI at risk for~     the development and poor healing of pressure ulcers due to microvascular dysfunction~     secondary to neurologic and metabolic disorders.~      Primary Aim: To determine the association between systemic insulin sensitivity and~     insulin-mediated vasodilatation below the neurological level of injury.~      We hypothesize that individuals with systemic insulin sensitivity compared to those with~     insulin resistance will have greater insulin-mediated vasodilatation and an associated~     proportional increase in cutaneous blood perfusion. Thus, intact and appropriate~     endothelial-mediated regulation by insulin will be operative despite sub-lesional~     neurological impairment in insulin sensitive individuals with SCI. However, because of the~     absence of the SNS-mediated insulin action on the microvasculature (i.e., insulin-mediated~     sympathetic withdrawal), it is being hypothesized that the vasodilatory response to~     iontophoresis with insulin in insulin sensitive subjects with SCI will be less than that~     observed in neurologically intact controls with insulin sensitivity.~      Secondary Aim: To compare peak microvascular perfusion responses to endothelial-dependent~     vasodilatation by iontophoresis with acetylcholine to insulin.~      We hypothesize that the peak blood perfusion responses to iontophoresis with insulin will be~     comparable in magnitude to that of acetylcholine in individuals with greater systemic insulin~     sensitivity. This will be in contrast to individuals with systemic insulin resistance who~     will demonstrate a diminished response to iontophoresis with insulin when compared to that of~     acetylcholine. Because of SNS impairment, the peak vasodilatory response observed to these~     interventions will be lower in the group with SCI.~   "
117134|NCT02034318|"~     The purpose of this research study is to learn about a possible association between cardiac~     denervation (the breaking down of nerves in the heart) and the development of fatigue in~     Parkinson's disease (PD).~   "
117135|NCT02034305|"~     This study is to determine whether physiologic measures (peak cough flow, measures of~     respiratory muscle strength including MIP, MEP ,SNIP, and spirometry) can predict spontaneous~     cough clearance (as measured by a nuclear medicine study) in children with neuromuscular~     disease. It will also determine whether airway clearance is augmented by high frequency chest~     wall oscillation.~   "
117136|NCT02034292|"~     Evaluating safety and PK parameter of APD-791 when co-administered with aspirin and~     clopidogrel.~   "
117137|NCT02034279|"~     The aim of this study is to evaluate whether albumin administration improves short-term~     survival in patients with advanced cirrhosis and bacterial infections other than Spontaneous~     Bacterial Peritonitis (SBP).~   "
117138|NCT02034266|"~     Nerves are made of different fats including omega-3s and omega-6s; however, dietary intakes~     of omega-6s are very high and omega-3 intakes are very low. We hypothesize that omega-3~     supplementation will stop diabetes related changes in cornea nerve structure in patients with~     type 1 diabetes to stop the development of nerve injury associated with future risk of~     neuropathy, and reflect changes in the degree of nerve injury over time. As such, we~     anticipate that patients in the study will maintain Corneal Nerve Fiber Length (CNFL), the~     primary outcome measure.~   "
117139|NCT02034253|"~     The early stages of schizophrenia are associated with significant decreases in social and~     intellectual abilities, with more declines in chronic disease. Studies have identified~     relationships between duration of untreated psychosis (the duration between the onset of~     positive symptoms and treatment) and worse long term outcomes. However, the neurobiology of~     this phenomenon and its implications for response to antipsychotic medications remain poorly~     understood.~      Glutamatergic excess altering brain connectivity might provide an explanation for why those~     with longer duration of untreated psychosis have worse clinical outcomes. The investigators~     propose to use neuroimaging to study 67 first episode psychosis subjects before and after~     sixteen weeks of treatment with risperidone, a common antipsychotic. We will measure (1)~     glutamate and (2) structural and functional brain connectivity and test the hypotheses that~     glutamatergic abnormalities are present in first episode patients and that longer duration of~     untreated psychosis is associated with greater connectivity abnormalities that set the stage~     for poor response to treatment. 67 demographic-matched controls will also be recruited as a~     comparison group - healthy controls will not receive antipsychotic medication.~      The investigator's previous studies have made progress in the understanding of abnormalities~     in the glutamate system and brain connectivity in unmedicated patients with schizophrenia and~     modulation of these by antipsychotic medication. Two indices of glutamatergic dysfunction~     have been identified. While antipsychotic medications appear to modulate glutamate, the~     disturbance in the relationship between metabolites is not restored with treatment. In~     addition, the investigators found that both structural and functional connectivity~     abnormalities in unmedicated patients with schizophrenia predict patients' response to~     treatment.~      To the investigator's knowledge, no other group has performed a study that uses a combination~     of complementary neuroimaging techniques that will allow generating a broad characterization~     of glutamatergic function and brain connectivity in first episode psychosis and change with~     treatment. The results of the proposed studies could suggest a mechanism by which the~     duration of untreated psychosis is associated with poor treatment response which might lead~     to new interventions to target the illness.~   "
117140|NCT02034240|"~     Patients with severe infection and sepsis are in high risk of hypo perfusion and therefore~     organ affection. Temporary or permanent kidney failure is a common complication in these~     patients. Today's golden standard for kidney failure detection is creatinine levels rising~     and / or oliguria. The investigators hypothesize that an even more sensitive biomarker;~     neutrophil gelatinase associated lipocalin(NGAL) in urine can predict kidney injury before~     creatinine levels rise. In recent studies NGAL in urine seem to be a sensitive biomarker in~     these patient to predict kidney injury, but the time factor for sampling optimally is not~     known. In this pilot study the investigators sample the urine at admission within the first~     hour of hospitalization to investigate if NGAL can be used as a predictor in an emergency~     setting.~   "
117141|NCT02034227|"~     The purpose of this study is to determine if the experimental drug, SG2000 is safe and~     tolerable in the treatment of participants with advanced chronic lymphocytic leukemia and~     acute myeloid leukemia whose standard treatment did not work, whose cancer came back or who~     are not candidates for other types of standard therapy.~   "
117142|NCT02034214|"~     The SHAZ! study was a randomized trial that compared a package of life skills education,~     reproductive health care services, and economic livelihood development to a control package~     of life skills education and reproductive health care services alone. SHAZ! enrolled young~     women 16 to 19 years old who had been orphaned and who were currently out of school and not~     infected with HIV. Individuals participated in the project for up to two years.~   "
117143|NCT02034201|"~     Methamphetamine dependence is a serious public health problem, with methamphetamine abusers~     being at risk for significant morbidity and mortality, including HIV. To date, no medication~     or psychotherapeutic strategy has shown robust, long-term efficacy in treating this disorder.~     This clinical trial will examine whether lisdexamfetamine shows promise in alleviating~     withdrawal symptoms and preventing relapse relative to placebo in recently-abstinent~     methamphetamine dependent individuals. Findings of this study will not only shed light on~     whether lisdexamfetamine may improve upon treatment for this disorder but also inform future~     medication development strategies for improving treatment for drug dependence disorders.~     Discovering efficacious limited risk interventions that show more robust, longer-term~     outcomes would be beneficial both to the individual and society.~   "
117144|NCT02034188|"~     Allogeneic human umbilical cord tissue-derived stem cells injected intravenously (IV) once~     per day for 7 days is a safe and will induce a therapeutic effect in multiple sclerosis (MS)~     patients.~   "
117149|NCT02034123|"~     GSK2879552 is a potent, selective, mechanism-based inactivator of Lysine Specific Demethylase~     1 (LSD1)/ CoRepressor for Element-1-Silencing Transcription factor (CoREST) activity. This is~     a phase I, open-label, multi-center, non-randomized, 2-part first time in human (FTIH) study~     for GSK2879552. Part 1 is a dose escalation phase to determine the recommended phase 2 dose~     (RP2D) for GSK2879552 based on the safety, tolerability, pharmacokinetics (PK) and~     pharmacodynamics (PD) profiles observed after oral administration of GSK2879552. Any dose~     level(s) may be expanded up to 12 subjects in order to collect additional data on PK and~     PD.The safety and PK/PD data will be reviewed prior to the dose decision, and the dose~     escalation will be guided by the Neuenschwander -continuous reassessment method (N-CRM).~     Built-in safety constraints are in place to prevent exposing subjects to undue risk of~     toxicity. Once RP2D is identified, an expansion cohort (Part 2) of up to 30 subjects will be~     enrolled to further evaluate the clinical activity and tolerability of GSK2879552 in subjects~     with relapsed/refractory SCLC.~   "
117150|NCT02034110|"~     This is a Phase II, open-label, non-randomized, multi-center study of oral Dabrafenib in~     combination with oral Trametinib in subjects with rare cancers including anaplastic thyroid~     cancer, biliary tract cancer, gastrointestinal stromal tumor, non-seminomatous germ cell~     tumor/non-geminomatous germ cell tumor, hairy cell leukemia, World Health Organization (WHO)~     Grade 1 or 2 glioma, WHO Grade 3 or 4 (high-grade) glioma, multiple myeloma, and~     adenocarcinoma of the small intestine, with BRAF V600E positive-mutations. This study is~     designed to determine the overall response rate (ORR) of oral Dabrafenib in combination with~     oral Trametinib in subjects with rare BRAF V600E mutated cancers. Subjects will need to have~     a fresh or frozen tumor tissue sample provided to confirm the BRAF V600E mutation status.~     Only subjects with histologically confirmed advanced disease and no available standard~     treatment options will be eligible for enrollment. Subjects will undergo screening~     assessments within 14 days (up to 35 days for ophthalmology exam, echocardiogram or disease~     assessments) prior to the start of treatment to determine their eligibility for enrollment in~     the study.~   "
117151|NCT02034097|"~     Foretinib (GSK1363089) is an investigational, oral, multikinase inhibitor involved in~     invasion, migration, and angiogenesis. This is a phase II, open label, uncontrolled,~     parallel, multi-cohort, multicenter 2-stage study to assess the safety and efficacy of~     foretinib and erlotinib combination therapy and foretinib monotherapy in genomic~     subpopulations of Non-Small-Cell Lung Cancer (NSCLC) subjects.~   "
117152|NCT02034084|"~     Previous studies have shown that the transradial cardiac catheterization has decreased not~     only bleeding complications related to the access site and procedural discomfort but also~     morbidity and hospitalization as compared to transfemoral approach. At present, the right~     radial approach (RRA) is the first choice routinely for coronary angiography and~     interventions in daily clinical practice despite more marked subclavian artery tortuosity~     than left radial approach (LRA). Although LRA has been thought to be more direct access to~     the ascending aorta similar to transfemoral approach and may reduce fluoroscopy time and~     cerebrovascular complications compared with RRA, the application of LRA for coronary~     intervention is still low. Moreover, several studies have also obtained conflicting results~     showing no difference in procedural success rate compared LRA and RRA using Judkins~     catheters. To date, it remains unclear whether LRA is superior to RRA in term of safety and~     feasibility for coronary angiography and interventions in real world practice and few data of~     randomized control trial are available.~      The aim of this study was to randomly investigate and compare the safety and feasibility of~     LRA compared with RRA for coronary diagnostic angiography in Chinese subjects.~      The investigators will enroll consecutively for 2 years all patients undergoing coronary~     diagnostic procedures through trans radial approach.~      The primary outcome was total procedural duration. Secondary outcomes included fluoroscopy~     time, dose of radiation including cumulative air kerma and dose area product, contrast volume~     and the incidence of vascular complications.~   "
117153|NCT02034071|"~     • This is a single-center, open-label, single-arm study with a double-blind,~     placebo-controlled, randomized withdrawal extension. Patients are initiated on a DCCR dose of~     about 1.5 mg/kg (maximum starting dose of 145 mg) and are titrated every 14 days to about 2.4~     mg/kg, 3.3 mg/kg, 4.2 mg/kg, and 5.1 mg/kg (maximum dose of 507.5 mg). These DCCR doses are~     equivalent to diazoxide doses of 1.03, 1.66, 2.28, 2.9, and 3.52 mg/kg. The administered dose~     will be as close to the mg/kg dosing as can be achieved by the available dose strengths of~     DCCR. Patients will be up-titrated at each visit at the discretion of the investigator. All~     patients will be continued in the double-blind, placebo-controlled, randomized withdrawal~     extension. Any patient who showed an increase in resting energy expenditure and/or a~     reduction in hyperphagia from Baseline through Day 55 or Day 69 will be designated a~     responder, whereas all others will be designated non-responders. Responders will be~     randomized in a 1:1 ratio either to continue on active treatment at the dose they were~     treated with on Day 69 or to the placebo equivalent of that dose for an additional 4 weeks.~     Non-responders will continue open label treatment during the extension.~   "
117154|NCT02034058|"~     The primary objective of this study is to evaluate the rate of stroke and/or death in~     patients treated with the Wingspan Stent System, according to the Indications for Use, within~     72 hours post procedure.~   "
117155|NCT02034045|"~     Initiatives aimed at reducing Emergency Department (ED) wait times and improved community~     health initiatives are major priorities in Canada. Three of the most common chronic diseases~     worldwide are Diabetes Mellitus (DM), Congestive Heart Failure (CHF) and Chronic Obstructive~     Pulmonary Disease (COPD). These diseases are on the rise and currently cost the Canadian~     health care system billions of dollars every year including the cost of hospitalizations and~     ED visits. The existing health care system does not have the resources and manpower to~     effectively care for these patients in the future.~      Paramedics are currently employed to provide Emergency Medical Services in remote, rural and~     urban settings in Canada.~      They are highly trained health care practitioners that are mobile in the community and~     currently work in a physician medically delegated act model and therefore are positioned to~     take on new collaborative roles to deliver patient care in the community setting. Increased~     community paramedic care could decrease the utilization of the health care system resources~     for patients with chronic disease. Using a randomized control trial design we will attempt to~     answer the question of whether whether non-emergency community paramedics conducting home~     visits to undertake assessments and evidence-based treatments of patients in partnership with~     family doctors will decrease the rate of patient hospitalization.~   "
117161|NCT02033967|"~     Induced hypovolemia is known to improve surgical field during living donor hepatectomy. This~     procedure is conventionally guided by monitoring the central venous pressure (CVP). Stroke~     volume variation (SVV) is a novel method to substitute with CVP to monitor cardiac preload.~     The investigators try to evaluate the relationship between CVP and SVV during CVP-guided~     vasodilator induced hypovolemia (validation study). Then, feasibility of vasodilator induced~     hypovolemia using the SVV calculated from the validation study will be tested (feasibility~     study).~   "
117162|NCT02033954|"~     To collect confirmatory data in support of the safety and performance of the ArtVentive~     Medical Group Endoluminal Occlusion System.~   "
117163|NCT02033941|"~     Alzheimer Disease (AD) is a progressive brain disease generally known as senile dementia. Our~     proposed study will establish safety and pharmacokinetics of Meganatural-AZ GSPE in AD~     subjects. As secondary measures, we will also provide the essential human data to guide the~     design of future studies to test the efficacy of GSPE in mitigating cognitive deterioration~     in AD patients.~   "
117164|NCT02033928|"~     The purpose of this research study is to describe a patients' fitness before and after~     treatment (whether that treatment be chemotherapy or a transplant). Fitness is a way of~     measuring a patient's current quality of health. With surveys, questionnaires and blood~     tests, we hope to create a tool that will give a good picture of patients' ability to~     tolerate treatment. In the future, we hope to devise the best treatment for a patient based~     on their fitness.~   "
117165|NCT02033915|"~     Suicide attempters or people with self-harm have a high percentage in seeking medical~     services before and after their suicidal or self-harm behaviour compared to general~     population. Studies revealed that apart from psychiatric services, they were more likely to~     seek help from doctors of various units (e.g. emergency departments, general medicine,~     medical-surgical units) across different healthcare systems (i.e. hospitals or district~     clinics). Besides, suicide event was possibly heard on in-patients of psychiatric or~     non-psychiatric units. People with self-harm experienced poor communication with healthcare~     personnel, and they perceived staff's lacking knowledge about suicide as serious problems. In~     Taiwan it was also found that emergency nurses and general practitioners were in need of~     improving negative attitudes and enhancing knowledge towards suicidal behaviour. From the~     point that nurses are the healthcare personnel that spend the most time with in-patients~     compared to others in the hospital, suicide risk assessment training may enhance nurses'~     attitudes and ability of risk awareness and assessment towards people with self-harm, which~     may in turn significantly increase the identification rate of the high risk group for~     suicide. Currently there is a lack of suicide training program as a reference for nursing~     education in Taiwan. The study therefore aims to strengthen suicide risk assessment ability~     among clinical nurses through interactive discussion groups. Using quasi-experimental design~     with randomized cluster sampling strategy, a case vignettes will be used for suicide risk~     assessment together with other measurements regarding suicide knowledge and attitudes for~     both experiment and control groups before and after the training course.~   "
117166|NCT02033902|"~     The purpose of this study is to evaluate the safety and tolerability of Fycompa (Perampanel)~     as an add-on therapy in epilepsy patients aged greater than or equal to 12 years.~   "
117167|NCT02033889|"~     This is an efficacy and safety study of ertugliflozin in participants with type 2 diabetes~     mellitus and inadequate glycemic control on metformin monotherapy. The primary study~     hypothesis is that at Week 26, the mean reduction from baseline in hemoglobin A1c (HbA1c) for~     ertugliflozin is greater than that for placebo.~   "
117168|NCT02033876|"~     This study will evaluate whether bile acids are able to increase insulin sensitivity and~     enhance glycemic control in T2DM patients, as well as exploring the mechanisms that enhance~     glycemic control. These observations will provide the preliminary data for proposing future~     therapeutic as well as further mechanistic studies of the role of bile acids in the control~     of glycemia in T2DM.~   "
117169|NCT02033863|"~     To collect confirmatory data in support of the safety and performance of the ArtVentive~     Medical Group Endoluminal Occlusion System.~   "
117170|NCT02033850|"~     Background: Subcortical Vascular Dementia (VaD), consequent to deep brain small vessel~     disease (SVD), is the most frequent form of VaD. The term vascular mild cognitive impairment~     (VMCI) defines a transitional state between normal ageing and VaD. Attentional deficits are a~     common finding in patients affected by VMCI or subcortical VaD. At present, no drug treatment~     is available to prevent vascular dementia in patients with VMCI or to improve cognitive~     performances of this large group of patients. Cognitive rehabilitation is directed to achieve~     functional changes by reinforcing, strengthening, or reestablishing previously learned~     patterns of behavior, or establishing new patterns of cognitive activity or compensatory~     mechanisms.~      A hierarchical model of attention has been used to build the Attention Process Training-II~     (APT-II) programme.~      The APT-II programme effectiveness have been demonstrated in traumatic brain injury and~     post-stroke rehabilitation, but there is an increasing interest in the study of cognitive~     rehabilitation in pathological processes that evolve over time, such as chronic~     cerebrovascular diseases (CVD).~      Aims: The purpose of this study is to investigate whether the APT-II programme could be a~     useful tool in the rehabilitation of attention in individuals affected by VMCI with SVD, and~     if so, whether the improvement in performance is generalized to functionality in daily~     activities and quality of life.~      Main Expected Results and Impact: Considering that the APT-II contains specific exercises to~     facilitate generalization to daily life, the skills that are learned by each patient during~     the rehabilitation programme should be generalized to daily activities.~      Furthermore, the improvement of cognitive skills should also improve patient's overall~     quality of life because these learned skills are applicable to real-life situations. The main~     expected results are: 1) an impact of APT-II on disability, everyday cognition, quality of~     life, and performance on attention tests at short and long term after rehabilitation~     programme ending as compared with standard care; 2) a reduction of the risk of transition to~     dementia at 1 year follow-up as compared with control group.~   "
117171|NCT02033837|"~     The influence of the second-generation 320-row area-detector CT (ADCT) on the clinical~     indications and appropriateness of cardiac CT has not been adequately investigated. The~     purpose of the survey is to assess the distribution of appropriateness ratings and test~     outcomes of cardiac CT with second-generation ADCT.~   "
117172|NCT02033824|"~     The purpose of this study is to evaluate the effectiveness of dHACM in reducing scar tissue~     formation in craniectomy patients as well as facilitating reoperation and repair.~     Specifically this study compares craniectomy without dHACM application to craniectomy with~     placement of dHACM between the galea and dura over dural suture line and/or exposed~     parenchyma.~   "
117173|NCT02033811|"~     Percutaneous mitral valve repair with the MitraClip® system has emerged as a therapeutic~     alternative to surgical valve repair (PMVR) in high risk patients.~      The aim of this registry is to collect prospectively and systematically clinical research~     data from patients undergoing PMVR with the MitraClip® system. This registry is an open-end~     observational study to assess the characteristics and outcomes patients with severe mitral~     regurgitation undergoing PMVR.~   "
117177|NCT02033759|"~     We propose to study the impact of BIA screening on anxiety and primary prevention strategies~     for lymphedema development among patients with recent surgery for breast cancer. Currently,~     professional societies recommend scheduled follow-up visits to screen for lymphedema after~     recovery from breast cancer (e.g., 6-week, 3-month, 6-month visits with a certified~     lymphedema therapist). Screening involves a discussion of lymphedema symptoms and risk~     reduction strategies, measurement of the affected limb with a tape measure, and physical~     inspection for physical changes consistent with lymphedema. In the proposed study, patients~     will be randomly assigned to the addition of BIA screening vs. usual care. At each screening~     visit, all patients will be assessed for their current lymphedema risk behaviors, as outlined~     by the National Lymphedema Network (7). To evaluate anxiety levels, all patients will be~     asked to fill out the Beck Anxiety Inventory, a validated screening tool used in prior~     studies of patients with breast cancer (8,9). This questionnaire will be administered at each~     follow-up lymphedema screening visit, and the baseline will be administered at the~     preoperative visit. For patients randomly assigned to BIA screening, this involves the~     placement of adhesive electrodes on the each wrist and an ankle, followed by connection of~     the electrodes to the BIA machine, which then uses a painless electrical impulse to measure~     impedance of flow and thus asymmetry in the extracellular lymphedema volume between the 2~     upper limbs (6,10). Statistical analysis will involve comparison of lymphedema risk behaviors~     and anxiety levels between those patients with vs. without BIA screening.~   "
117178|NCT02033746|"~     Pilot study of 12 outpatients in early recovery from illicit drug use,post-detox and on~     buprenorphine-naloxone maintenance will be offered 12 TEAS adjunct treatments over 6~     weeks(X2/week) to ascertain if they experience any improvement in mood,sleep,overall quality~     of life and decrease drug cravings ultimately while facing everyday life stressors.~   "
117179|NCT02033733|"~     After successful resuscitation from cardiac arrest, cooling the whole body is a well~     established treatment that improves the chances of the brain recovering. This however, has to~     be done within a certain time-frame from the arrest. The purpose of this study is to explore~     the best way of dosing the muscle relaxing medications that are given during the cooling~     process.~      Hypothesis: In the context of our institutional therapeutic hypothermia protocol,~     cisatracurium infusions lead to faster drops in core temperature when compared to~     cisatracurium prn boluses alone.~   "
117180|NCT02033720|"~     After successful resuscitation from certain types of cardiac arrest, total body cooling is~     now a well established treatment that improves the chances of the brain recovering. This~     however, has only been definitively proven after a certain type of cardiac arrest that is~     ventricular fibrillation / ventricular tachycardia. The purpose of this study is to explore~     if total body cooling is beneficial for patients recovering from another type of cardiac~     arrest that is pulseless electrical activity.~      HYPOTHESIS:~      Patients undergoing post-cardiac arrest therapeutic hypothermia have better neurological~     outcomes if their initial arrest rhythm is pulseless electrical activity (PEA) in comparison~     to asystole.~   "
117181|NCT02033707|"~     This non-treatment study will investigate the effects on mood and performance caused by~     hallucinogens and other psychoactive compounds.~   "
117182|NCT02033694|"~     The purpose of this study is to enhance medical knowledge of the causes of future coronary~     problems. Many studies in patients who have already experienced a coronary problem point to~     the danger associated with plaques that are rich in cholesterol. This study determines if the~     near-infrared method of detection of these fatty plaques can predict future events. If~     dangerous plaques can be identified, there are many treatments already available that could~     be tested for their ability to prevent coronary events.~   "
117183|NCT02033681|"~     The aim of this study is to know the characteristic of one-per-mil tumescent solution in~     regards of the optimal time delay to achieve optimal visualization of operation field in hand~     and digit surgery.~      Hypothesis:~        1. Epinephine in one-per-mil concentration by tumescent injection technique will provide~          faster decrease in oxygen saturation compared to normal saline solution injected by~          tumescent technique.~        2. Epinephrine in one-per-mil concentration by tumescent injection technique will provide~          effectiveness in vasoconstriction longer than 10 minutes as the optimal time delay.~        3. Epinephine in one-per-mil concentration by tumescent injection technique causes no~          finger necrosis as normal saline solution injected by tumescent technique.~   "
117184|NCT02033668|"~     This study is intended to enable a possible transition to intramuscular (IM) or subcutaneous~     (SQ) administration for subsequent studies with GSK933776 by characterizing the safety,~     tolerability, PK and pharmacodynamic profiles, and immunogenicity of GSK933776 following IM~     and SQ administration in healthy volunteers. Such alternate routes of administration may~     provide more options in the selection of an efficacious dose for subsequent development in~     patients with geographic atrophy. There will be four treatment arms in the study and~     participants will be assigned to 1 of 4 possible treatment arms in a 1:1:1:1 ratio. The~     planned number of evaluable participants for this study is 24 with 6 participants completing~     all critical assessments in each of the four treatment arms. The total duration of~     participation from screening to follow-up for Treatment Arms A, B and D (single dose of~     GSK933776), will be approximately 113 days and total duration for Treatment Arm C (repeat~     dose of GSK933776) will be approximately 134 days.~   "
117185|NCT02033655|"~     The purpose of the trial is to assess the effects of combining regular, generous intakes of~     high quality protein (primarily from lean pork and other animal source proteins) with calorie~     restriction on functional status and lean muscle mass in frail, obese, women who participate~     in a 6 month intervention and 9 month intervention.~   "
117203|NCT02033421|"~     The recommended length of antibiotic treatment to patients with infective endocarditis is 4-6~     weeks. All patients receive the same dosis except for those with renal impairment who receive~     a smaller dose. For Beta-lactam antibiotics, a plasma concentration above the minimal~     inhibitory concentration (MIC) for at least 50% of the time in a dosing interval maximize~     bactericidal activity. To estimate the time for which the antibiotic concentration is above~     the MIC (T>MIC) and to see if there might be a relationship between the concentration of~     antibiotics and possible side-effects, toxicity and treatment failure, all patients admitted~     with infective endocarditis will be followed and have two blood tests withdrawn once a week~     during antibiotic treatment, an expected average of 5 weeks.~   "
117186|NCT02033642|"~     The first purpose of this randomized controlled trial is to test the efficacy of a~     24-session, 6-month family-based behavioral intervention (FBBI) - as compared to a delayed~     treatment group which later receives the same FBBI - that targets weight loss in~     adolescents/young adults with intellectual disability aged 15-22 years. The second purpose of~     this randomized controlled trial is to examine the efficacy of a 12-session, 6-month~     Maintenance intervention that targets maintenance of weight loss in the same population of~     adolescents/young adults with intellectual disability. The Maintenance condition follows the~     completion of each FBBI group and involves a re-randomization to either the Maintenance~     intervention or no further intervention. Outcome measures include Body Mass Index (BMI),~     waist circumference, physical activity/sedentary behavior (measured via accelerometry),~     dietary patterns (3-Day Food Records), self-efficacy and psychosocial characteristics~     (Adolescent Depression and Anxiety Scale). Hypotheses are that (1) participants in the FBBI~     condition will lose more weight (reduced BMI) than participants in the delayed treatment~     condition, and that (2) participants in the Maintenance condition will maintain weight lost~     (reductions in BMI) or experience less weight regain, as compared with participants who~     receive no further intervention following FBBI.~   "
117187|NCT02033629|"~     The development of target effect-site controlled concentrations (TCI) of remifentanil have~     gained increasing acceptance during cardiac surgery as regarding the resulting of hemodynamic~     stability and early extubation. The use of low-dose opioid technique has been progressively~     used nowadays because of its ceiling effect to attenuate cardiovascular responses to noxious~     stimuli. We hypothesize that the use of low target remifentanil effect site concentrations~     may provide comparable shorter times to tracheal extubation and hemodynamic stability to the~     use of high remifentanil Ce during target-controlled propofol anesthesia for cardiac surgery.~   "
117188|NCT02033616|"~     This is a double-blind study in which approximately 99 study patients will be randomized in a~     2:1 ratio to receive either AVOVA-1 or MC. Patients eligible for randomization and treatment~     will be those (1) who have undergone debulking surgery, (2) for whom a cell line has been~     established, (3) who have undergone leukapheresis from which sufficient PMBC were obtained,~     and (4) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%).~      The primary endpoint of this trial is death from any cause with the metric of OS from the~     date of randomization. PFS will be a secondary endpoint and will be calculated as the time~     from the date of randomization for treatment until subjective tumor progression or death.~     Progression will be subjectively defined by the treating physician, and is expected to be~     based on tumor marker levels (e.g. CA-125) and/or imaging. Secondarily, we will also define~     PFS and OS from the date of debulking surgery.~      Patients will be stratified into (1) no evidence of disease (NED) (no measurable or~     non-measurable disease per RECIST and normal CA-125 levels) or (2) non-NED (measurable or~     non-measurable disease per RECIST or elevated CA-125 levels).~   "
117189|NCT02033603|"~     Total knee arthroplasty or replacement (TKA) is a surgery performed for osteoarthritis of the~     knee which is increasingly performed as the population ages. It is a painful surgery and one~     of the methods to reduce post-operative pain is performing a regional anaesthesia technique.~     The current practice is to perform a femoral nerve block (FNB) which blocks the nerves~     supplying the knee joint and the thigh muscles (quadriceps). This provides effective~     analgesia. However, it also results in weakness of the quadriceps and may result in falls~     post-operatively.~      Adductor canal block (ACB) is a new, alternative regional anaesthesia technique which is~     hypothesised to provide as effective analgesia, with less quadriceps weakness compared to~     FNB, hence potentially reducing the risk of falls post-operatively.~      Investigators aim to study if the analgesia provided by ACB is as good as FNB while~     preserving quadriceps strength.~   "
117190|NCT02033590|"~     The objective of this study is to prospectively observe clinical and economic outcomes with~     the use of SERI® in direct-to-implant breast reconstruction.~   "
117191|NCT02033577|"~     Surgical bypassing of a longer section of the small bowel (when doing a gastric bypass~     operation) gives better results on body weight in the superobese. We do not yet know whether~     it is beneficial to exclude more of the proximal small bowel or more of the distal. Side~     effects of bypassing can also be different.~      Study aims at clarifying possible differences in effects and side-effects of these two~     surgical-technical variations.~   "
117192|NCT02033564|"~     The purpose in this study is to determine whether there is a difference in the incidence of~     postoperative sore throat when using the GlideScope™ versus a traditional intubation blade~     involving patients that are not anticipated to have a difficult airway.~   "
117193|NCT02033551|"~     This is an extension study to evaluate the safety of Veliparib monotherapy or in combination~     with Carboplatin plus Paclitaxel or modified Folinic Acid/Fluorouracil/Irinotecan (FOLFIRI)~     in subjects with solid tumors.~   "
117194|NCT02033538|"~     Albumin-bound paclitaxel regimen in advanced NSCLC has a better tumor response rate and~     safety than solvent-based paclitaxel. However, the safety and efficacy is uncertain in~     neoadjuvant therapy in esophageal cancer. The objective of this single-arm phase II trial was~     to evaluate the benefit of neoadjuvant chemotherapy with nanoparticle albumin-bound~     paclitaxel plus 5-fluorouracil in patients with locally advanced esophageal squamous cell~     carcinoma.~   "
117195|NCT02033525|"~     The present proposal has the objective to assess whether the addition of autologous ex vivo~     expanded mesenchymal stromal cells (XCEL-M-ALPHA) to the conventional meniscal injury~     rehabilitation program is contributing in creating the proper healing environment for the~     meniscus repair. For this purpose, 20 patients will be randomized (10 per group) to one of~     the two treatment arms (rehabilitation + xcel-m-alpha or rehabilitation alone) . The~     conduction of this clinical trial will, in addition of having the aim of improving the~     patient's quality of life, contribute to consolidate an emerging new type of therapy which is~     still under development.~   "
117196|NCT02033512|"~     There is a dilemma and a permanent debate about side effects on drugs administered orally.~     The first-pass metabolism is related with many side effects, since the metabolites of these~     compounds affect the course of human physiology. Conventional hormone therapy by oral route~     has been used for relieving menopausal symptoms. Transdermal estrogens have not been used~     extensively in Brazilian women with menopausal symptomatology, however; recently a previous~     long term study has indicated no increased risk breast cancer or vasomotor disorders in~     menopausal women, using transdermal HRT.~   "
117197|NCT02033499|"~     For the nearly 75% of patients living with type 2 diabetes (T2DM) that do not use insulin,~     decisions regarding self-monitoring of blood glucose (SMBG) are unclear. SMBG testing is a~     resource intensive activity without firmly established patient benefits. While SMBG holds~     great promise for sparking favorable behavior change, the potential for no benefit or even~     patient harm must be acknowledged. Possible negative effects on patient quality of life must~     be more closely examined along with the speculative benefits of SMBG in non-insulin treated~     T2DM. Among studies examining this issue a general consensus is evolving; while SMBG may or~     may not be useful, its value can only be fully appreciated when the SMBG results are provided~     to patients in a useful manner. The overarching goal of this proposal is to assess the impact~     of three different SMBG testing approaches on patient-centered outcomes in patients with~     non-insulin treated T2DM within the real-world, clinic setting. In this pragmatic trial, 450~     patients will be randomized to one of the following three SMBG testing regimens: 1) no SMBG~     testing, 2) once daily SMBG testing with standard patient feedback consisting of glucose~     values being immediately reported to the patient through the glucose meter, and 3) once daily~     SMBG testing with enhanced patient feedback consisting of glucose values being immediately~     reported to the patient plus automated, tailored feedback messaging. The first two arms~     represent common SMBG testing approaches. The third arm is an enhanced, patient-centered~     approach to SMBG testing. SMBG values will be evaluated at routine clinic visits over 52~     weeks.~   "
117198|NCT02033486|"~     Screening for breast cancer improves early detection of aggressive cancers and has been shown~     to reduce breast cancer related mortality. Currently, mammography is the most effective way~     of detecting early stage, non palpable breast cancers. However, mammography only reveals the~     breast structure, and cannot say much about the breast physiological state. We propose~     Tomographic Optical Breast Imaging (TOBI) as an inexpensive, patient friendly technique that~     is non-invasive and does not use non-ionizing radiation. TOBI uses near infrared light and by~     measuring how such light passes through the breast, images of blood volume and hemoglobin~     oxygenation can be obtained. In this study, TOBI is combined with digital breast~     tomosynthesis (DBT, a form of 3D mammography) and our hypothesis is that the TOBI-DBT~     combined images can be used to diagnose breast cancer with significantly improved sensitivity~     and specificity compared to DBT alone.~   "
117199|NCT02033473|"~     The (PYR1)-apelin-13 is an endogenous peptide discovered relatively recently (1998). The~     apelin and its receptor, which is named apj, are expressed in many tissues including~     sensitive to the action of insulin, such as skeletal muscle, adipose tissue and heart tissue.~      Recent work by the team of Prof. P.Valet (INSERM U1048, Toulouse) opened a new field of~     investigation, demonstrating for the first time in mouse models that apelin exerts a~     glucose-regulating in vivo action. The investigators propose a translational clinical~     research project whose goal is to provide the proof of concept of the favorable influence of~     apelin on insulin sensitivity in humans.~   "
117200|NCT02033460|"~     The purpose of this study is to know which combination of treatments are the most effective~     in patients with non-specific neck pain. Study design: This is a single-blind randomized~     controlled trial. (outcomes assessor). Study population: Men and women aged 18 to 60 years~     old with neck pain for at least 12 weeks. Interventions: 3 groups will be treated for a~     period of 4 weeks (8 sessions total; 2 per week).~   "
117201|NCT02033447|"~     Men with early prostate cancer face a number of options which lie at the extremes of care. On~     one hand, active surveillance involves monitoring the disease and on the other, immediate~     treatment involves surgery or radiotherapy. The difference between these two strategies in~     terms of reducing the chance of a man dying from his disease is small. Not only is the~     benefit small, surgery or radiotherapy carry significant side-effects. These occur because of~     damage to surrounding tissue resulting in incontinence of urine (1 in 5), erectile~     dysfunction (1 in 2) and back-passage bleeding, diarrhoea or discomfort (1 in 10).~      The investigators have been working on new forms of treatment that use heat, light or cold to~     destroy tissue and minimise treatment-related harms. The investigators have not yet found one~     that delivers the ideal treatment. The ideal treatment is one that can be done under local~     anaesthetic, can effectively destroy areas of cancer, limit damage to surrounding tissues, is~     repeatable, and adaptable to future discoveries such as molecular targeting of cancer cells.~      The investigators think magnetic thermoablation may be able to deliver on these ideal~     attributes. Magnetic thermoablation involves injecting magnetic iron nanoparticles directly~     into the cancer. When a magnetic field is applied close to them, these nanoparticles heat up~     to very high temperatures that kill cells. Magnetic thermoablation does not use x-rays or~     surgical incisions. The investigators have done a lot of the preclinical work already to~     develop this type of treatment. The investigators now need to develop a system that can be~     used to treat prostate cancer. However, before the investigators can do this, they need to~     test whether the magnetic nanoparticles actually stay where they are injected. The~     consequences of them moving to areas that they should not can be serious. First, the~     nanoparticles could move away from the cancer which means the cancer will not be heated~     effectively. Second, the nanoparticles could move to sensitive structures around the prostate~     (back-passage, bladder, sphincter muscle controlling urine flow, nerves controlling~     erections). If this happens, damage of those sensitive structures could occur leading to~     side-effects.~      The investigators propose a study to try and find out what happens to those nanoparticles.~     The study will involve approaching men who are having their prostates removed by radical~     surgery. If these patients agree to participate, the investigators will inject their prostate~     with varying amounts of nanoparticles. The investigators will NOT heat them up. The~     investigators will use special scans and, once they have had their surgery, to look at the~     pathology specimens to see where the nanoparticles have gone. The actual nanoparticles are~     not harmful but the process of injection can carry a small amount of harm. If the~     nanoparticles stay where they are injected, the investigators will then be able to run~     another study in which we treat men who have prostate cancer with magnetic thermoablation.~   "
117202|NCT02033434|"~     The investigators hypothesize that intra-nasal ketamine, for analgesia of patients with~     moderate to severe pain in an alpine setting, will provide a clinically significant reduction~     in pain and provide an effective and feasible alternative to intravenous opioids.~      The investigators wish to know:~        1. Is our study protocol feasible to study INK in a mountain, prehospital care environment?~        2. What estimate can be made of recruitment rates?~        3. Does studying the use of INK interfere with or delay care at Whistler/Blackcomb?~        4. Is intra-nasal ketamine an effective and safe method for controlling pain in our study~          population and setting?~        5. Does intranasal ketamine provide a clinically significant reduction in pain or do~          patients require additional IV narcotics for extraction?~        6. Are there any significant changes in vital signs after administration of intra-nasal~          ketamine~        7. Does the use of intra-nasal ketamine reduce time of patient extraction and transport in~          the alpine pre-hospital setting?~        8. Are there any long term sequelae of INK at one week?~   "
117204|NCT02033408|"~     the etiology of Inflammatory Bowel Diseases (IBD) is closely associated with the gut~     microbiome. The results of previous studies on the effectiveness of antibiotics and fecal~     macrobiota transplantation (FMT) are contradicting.~      Aims: to evaluate the effectiveness of wide-spectrum antibiotic regimens in acute severe~     colitis in an addition to standard corticosteroid therapy (UC and isolated UC-like Crohn's~     colitis). The secondary aim is to assess the outcome of FMT in those not responding to five~     days of therapy (in either arm). As an exploratory aim, any IBD patient with a resistant~     disease to at least two immunosuppressive medications, may be treated with either~     interventions.~   "
117205|NCT02033395|"~     This observational study follows subjects who have been exposed to a traumatic event and are~     at risk of developing PTSD symptoms. Participants are recruited within six hours of a~     traumatic event, and, starting from the recruitment session, are then examined on six set~     points of time within a period of thirteen months. The examinations include both biological~     studies of cortisol in hair, blood and saliva, and psychological examinations and~     questionaires that assess the development and severity of PTSD symptoms.~      The novel method of sampling hair cortisol allows investigators to retroactively estimate the~     mean levels of blood cortisol during the tree months prior to the sampling.~      The study aims at further illuminating the correlation between cortisol levels both prior and~     following a traumatic event, and the development and severity of PTSD symptoms~   "
117206|NCT02033382|"~     This study will identify and evaluate relevant biomarkers and structural brain imaging for~     understanding potential biological illness related mechanisms in medication-naïve subjects~     with early psychosis before and after initiation of antipsychotic medication~   "
117207|NCT02033369|"~     This study aims to determine whether ventral striatal dopamine release is a mechanism of~     reward motivation in major depression, whether dopamine release is low in depression, and~     whether DA release and reward motivation predict response to dopamine-targeted treatment with~     pramipexole.~   "
117208|NCT02033356|"~     The aim of this prospective dose finding study is to estimate the minimal effective volume~     (ED95) for lidocaine 1.0% for filling the adductor canal when placing an adductor canal~     block. We will apply the Continual Reassessment Method (CRM) for estimating the ED95 and use~     an MRI scan to evaluate the main objective and ensure spread to the distal part of the~     adductor canal.~   "
117209|NCT02033343|"~     The purpose of this study is to monitor movement of the prostate during radiotherapy and~     adjust the radiation beam to account for any motion seen. This will increase the radiation~     dose to the prostate and decrease the dose to the rectum and bladder.~   "
117210|NCT02033330|"~     In this study, the bioavailability of a specific orange peel extract is tested. The~     composition and morphology of the test product is altered compared to the generic product,~     which is used as a control. Due to intellectual property issues, more information cannot be~     given at this moment. Also the difference in bioavailability between a capsule and a lozenge~     is tested. The hypothesis is that the bioavailability of the altered extract will be improved~     compared to the control.~   "
117211|NCT02033317|"~     This study assessed the pharmacodynamic effects of patiromer on serum potassium in~     participants on hemodialysis.~   "
117212|NCT02033304|"~     In spite of identical analgesic protocols, parturients suffer different levels of pain~     postoperative lay. In this study we hope to identify factors which influence the perception~     of pain including preoperative anxiety, sleep quality and local anesthesia injection pain.~   "
117213|NCT02033291|"~     Cerebral small vessel disease (cSVD) encompasses all pathological processes that affect the~     small vessels of the brain. On brain-MRI cSVD is characterized by structural brain~     abnormalities such as white matter lesions (WMLs). Clinically, cSVD is related to acute~     syndromes as lacunar stroke but also to more chronic health problems such as cognitive~     decline. Recent literature suggests that a disrupted blood brain barrier (BBB), leading to~     elevated BBB permeability, may play a pivotal role in the aetiology of cSVD and lacunar~     stroke. The BBB is a complex system of neuronal, glial and vascular cells which main function~     is to shield the brain from toxic components and regulate the homeostasis. Elucidating the~     role of the BBB may have far reaching consequences for the treatment of cSVD patients and the~     reduction of recurrence rate of the disease. This could lead to a better quality of life~     among cSVD patients and reduce the economic burden on society. Currently the exact~     contribution and extent of a possibly defective BBB in cSVD remains largely unclear, due to~     the lack of a reliable method to accurately quantify the BBB permeability in cSVD patients.~     As a result, the current treatment consists of treating the cardiovascular risk factors,~     often with poor results.~      Quantification of the BBB permeability provides an objective measure of the integrity of the~     BBB and as such aids the study of the role of the BBB. The aim of this study is to realize a~     clinically applicable MRI-method to quantify the BBB permeability. Moreover, the method can~     be used to study the involvement of BBB disruption in other neuropathologies including~     Alzheimer's disease, vascular dementia, hypertension and diabetes.~      Primary Study Objective:~      To realize a clinically applicable quantification of BBB permeability using DCE-MRI by~     determining the reproducibility of the DCE-MRI method~      Secondary Study Objective:~      To achieve the shortest scan duration without compromising the reliability of the BBB~     permeability quantification.~      Hypotheses:~        1. Using an optimized DCE-MRI method to quantify the BBB permeability, the BBB permeability~          can be reliably determined in cSVD patients.~        2. The scan duration can be shortened without compromising the reliability of the BBB~          permeability quantification.~   "
117214|NCT02033278|"~     Clinical trial phase IIb, double-blind, randomized, controlled with placebo. There is~     sufficient preliminary evidence to consider intracoronary injection of bone marrow progenitor~     cells as a viable, safe and beneficial treatment in patients with dilated cardiomyopathy,~     although the biological mechanism of action of bone marrow cells in the myocardium is not~     known. In this project we propose to investigate comparatively and from a biological and~     clinical point of view the applicability of regenerative therapy with autologous bone marrow~     cells in patients with dilated cardiomyopathy.~   "
117215|NCT02033265|"~     Axillary brachial plexus block (freezing the nerves in armpit) is commonly performed as a~     primary anesthetic technique for the elbow/ forearm or hand surgery. These nerves are~     identified using ultrasound and nerve stimulator (by stimulating the nerves using a small~     current through the needle). Axillary brachial plexus block has been shown to result in~     better pain relief, less nausea, vomiting and early discharge from hospital. The use of these~     nerve blocks have also shown to decrease the duration of hospital stay, decreased side~     effects of opioids painkillers and better satisfaction scores over the conventional use of~     intravenous and oral pain medications. These beneficial effects are particularly useful for~     patients who are overweight or obese. A study by Hauouz et al published in Anesthesia and~     Analgesia in July 2010 suggests that the success rate of brachial plexus block is lower for~     obese and overweight patients. However, ultrasound guidance was not used for performing~     axillary brachial plexus block in this study. We propose that with usage of ultrasound~     guidance the success rate of brachial plexus block will be similar in obese and non-obese~     patients.~      In this study, we want to compare the success rate of axillary brachial plexus block for~     obese and non-obese patient groups. We would also like to look at performance time,~     complications and patient satisfaction for our study population.~   "
117216|NCT02033252|"~     This randomized controlled study aimed to evaluate the efficacy and safety of acupuncture~     therapy on persistent allergic rhinitis patients complicated with asthma.~   "
117217|NCT02033239|"~     This trial is conducted in Europe. The aim of this trial is to investigate the~     pharmacodynamic (the effect of the investigated drug on the body) response of Faster acting~     insulin aspart (FIAsp) in subjects with type 1 diabetes.~   "
117221|NCT02033187|"~     Healthcare-associated infections are a major cause of morbidity among critically ill~     patients. Bathing critically ill patients with cloths impregnated with the broad-spectrum~     antimicrobial agent chlorhexidine-gluconate may decrease healthcare-associated infections.~     The purpose of this study is to evaluate the effect of daily bathing with disposable~     chlorhexidine-impregnated bathing cloths, as compared to daily bathing with disposable~     standard non-chlorhexidine-impregnated bathing cloths, on the rates of healthcare-associated~     infections in critically-ill patients.~      Hypothesis: Daily bathing of the skin with chlorhexidine-impregnated bathing cloths will~     result in reduced rates of healthcare-associated infections in patients admitted to intensive~     care units (ICU).~   "
117222|NCT02033174|"~     Hypothesis: Red wine intake but not other alcoholic beverages together with a fat diet will~     decrease inflammatory factors and lipid peroxidation and decrease antioxidant capacity in~     healthy people after a five days period.~   "
117223|NCT02033161|"~     This pilot-study aims to evaluate the treatment effects and feasibility of an~     internet-delivered CBT-program for adolescents with functional gastrointestinal disorders.~   "
117224|NCT02033148|"~     This phase I trial studies the side effects and best dose of icotinib hydrochloride in~     treating patients with advanced cancers. Icotinib hydrochloride may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth.~   "
117225|NCT02033135|"~     This randomized clinical study is intended to evaluate the use of Zilver PTX stents for~     treatment of thigh atherosclerosis.~      Research question: Is there an adjuvant benefit of angioplasty and stenting using the new~     paclitaxel eluting stent, Zilver-PTX, over risk factor modification and medical therapy alone~     in patients with stable, mild to moderate intermittent claudication caused by femoropopliteal~     lesions suitable for endovascular management.~   "
117226|NCT02033122|"~     Exercise training has been proposed as adjunctive therapy in asthma to improve many clinical~     outcomes; however its effects on bronchial hyperresponsiveness (BHR) and inflammation,~     characteristic features in asthma, remains poorly understood. We aim to investigate the~     effects of aerobic training on BHR (primary aim) and systemic inflammation (secondary aim).~     In addition, clinical control and health related quality of life (HRQoL) will be also~     assessed.~   "
117227|NCT02033109|"~     This Phase 1 clinical trial will evaluate MIV-150, a third generation non-nucleoside reverse~     transcriptase inhibitor, co-formulated with a potentially potent agent, zinc acetate for the~     prevention of HIV infection in women. This is the first in-human of PC-1005 (MIV-150/zinc~     acetate in a carrageenan gel), the first study in which females will be exposed to MIV-150,~     the first time MIV-150 will be administered topically, and the first time MIV-150 will be~     administered intravaginally.~   "
117228|NCT02033096|"~     Follow-up, Having Received Stannsoporfin or Placebo in Clinical Trial 64,185-202~   "
117229|NCT02033083|"~     Primary objective: To study the difference in dilation and evacuation (D&E) procedure time~     following overnight cervical preparation with laminaria or Dilapan-S™. The investigators~     hypothesize procedure time will be less with Dilapan-S™.~      Secondary objectives: To compare the use of laminaria and Dilapan-S™ for differences in: (1)~     initial cervical dilation before D&E; (2) need for mechanical dilation to accomplish D&E and~     ease of dilation if required; (3) number of osmotic dilators placed; (4) ability to complete~     the D&E procedure without further cervical preparation; (5) complications; (6) pain and other~     side effects; (7) patient acceptability; and (8) provider acceptability.~   "
117230|NCT02033070|"~     The purpose of this study is to provide a tool for physicians to compare outcome data related~     to the use of the HALO Ablation Systems. This study is a single-center patient registry which~     will contribute to a framework for treatment and follow-up of patients with Barrett's~     Esophagus.~   "
117231|NCT02033057|"~     Even 20-50% of patients under sedation and mechanical ventilation develops myopathy and / or~     neuropathy which difficulties both the process of extubation and the functional recovery. The~     objective of this project is to analyze the effect of muscle electrostimulation (ESM) on~     muscle weakness acquired in Intensive Care Unit (ICU) and its consequences. Study design: a~     single center, prospective, randomized trial to be held in the ICU of  Universitarian~     hospital La Fe in collaboration with the service of Neurophysiology of the hospital. All~     patients undergoing sedation and mechanical ventilation (with an expected duration longer~     than 48h) and without any of the exclusion criteria detailed in the Methodology section will~     be included in the study. The intervention will consist of a muscular electrostimulation with~     the Super Pro Excel 70,UltratoneTM. The stimulation will be performed in 10 muscle groups (5~     per side) following established protocols, at least 5 days a week. We will evaluate muscle~     strength by Medical Research Council scale, functional capacity by Barthel scale and~     Neurophaty Disability Scale, all clinical events will be collected and electrophysiologic,~     echographic and histologic parameters will be measured. The process of extubation will be~     performed following an established protocol, the duration will be collected as the same~     manner as ICU.~   "
117232|NCT02033044|"~     Study design was a multicenter, randomized, rater-blind clinical trial. There were~     two-parallel arms (1:1) to evaluate functional, clinical and cognitive efficacy of a specific~     cognitive rehabilitation group intervention (CR) compared with a psychoeducational group~     intervention (PE) in subjects with Borderline Personality Disorder (BPD).~   "
117252|NCT02032771|"~     Up to 40 healthy subjects at 2 sites, age 30-65 year old with Fitzpatrick-Elastosis score of~     3-6 and mild to moderate age/sun-related facial pigmentation that wish to improve their~     facial skin appearance.~      Hypothesis: The SST will improve the appearance of the wrinkles/elastosis and/or pigmentation~     by at least 1 on the FES scale or ≥50% in category scale at 3 months follow-ups in at least~     50% of the study population.~   "
117253|NCT02032758|"~     The investigators will investigate golfers with visual evidence of an involuntary movement~     while putting before and after treatment with a low dose of propranolol.~   "
117254|NCT02032745|"~     A genomic test was developed to predict chemo-sensitivity to taxane-anthracycline-based~     chemotherapy as neoadjuvant treatment. The primary aim of this study is to prospectively~     evaluate the microarray-based, genomic test as a predictor of axillary lymph node response.~     Also, to determine whether the probability of achieving negative axillary nodes, is~     sufficiently high for patients whose breast cancer is predicted to be chemo-sensitive to~     support omitting axillary dissection.~   "
117233|NCT02033031|"~     Retinal vein occlusion (RVO) is the second leading cause of retinal vascular disease in~     patients older than 50 years.The prevalence varies from 0.7% to 1.6% in the literature.~      Visual recovery depends on ischemic damage of the retina, the occurence of macular edema (ME)~     and the development of neovascular glaucoma. The occurence of ME is the main reason for~     visual loss and frustrates visual recovery among patients with both central or branch RVO.~      Therapeutic options that have been used and discussed over the years are the treatment with~     anticoagulants, fibrinolytics, corticosteroids, acetazolamide and isovolemic haemodilution.~     Furthermore, surgical options like vitrectomy and radial optic neurotomy were used.~     Panretinal photocoagulation and grid pattern photocoagulation had established as additional~     tool to induce chorioretinal anastomosis. Nevertheless, the effectiveness and the evidence of~     these different treatment options could not be verified and remains mostly unknown.~      Nowadays, intravitreal anti-VEGF application had become the treatment of choice for ME~     secondary to RVO. Multi-center studies have already shown the effectiveness of anti-VEGF~     treatment to reduce intraretinal fluid and retinal hemorrhages (BRAVO, CRUISE).~     Unfortunately, often high numbers of re-treatments become necessary over the years. In our~     knowledge, there are no reports showing more than 3 years treatment effects of antiangiogenic~     drugs in patients with BRVO. However, the results of treatment effect longer than 3 years are~     important, as the mean age < 70 years with an onset of BRVO has been estimated in about 60%~     of all cases. In addition, most patients with regard to the application of anti-VEGF~     treatment in real clinical setting, there is only rare experience concerning need of optimum~     time duration for follow-up at the departments. Hence, the present study aimed to evaluate~     the long-term clinical outcomes, safety and therapeutic benefit of a flexible dosing regimen~     of intravitreal anti-VEGF therapy in patients with ME secondary to BRVO.~   "
117234|NCT02033018|"~     The purpose of this study is to evaluate the clinical results of anti-VEGF intra-vitreal~     injections (IVT) in CNV secondary~   "
117235|NCT02033005|"~     Breast feeding is believed to be beneficial to long-term health but how these effects are~     mediated is unknown. I suggest that this may be through effects on body composition and~     metabolism.~      I will compare adipose tissue and liver fat deposition in healthy, full term breast and~     formula fed infants babies shortly after birth and around 12 weeks.~   "
117236|NCT02032979|"~     The investigators propose to conduct a comparative pilot cognitive and psychiatric profiles~     of 10 patients Facio-Scapulo-Humeral Dystrophy (= FHSD) type 1 and 10 patients with type 2~     FSHD study. For this, the investigators relied on observational components: FSHD2 patients~     appear more often present with psychiatric comorbidities and seem to have lower cognitive~     performance compared to FSHD1 patients. This was confirmed by a preliminary study on a small~     sample population of patients. It seems to exist mainly executive dysfunction associated with~     attention disorders in patients FSHD2. Moreover, their performance in IQ tests would be low~     in relation to their socio-educational and compared with patients FSHD1 level.~   "
117237|NCT02032966|"~     Isolated surgical repair of the inside portion of the tibia may be enough to stabilize an~     ankle fracture in which both the tibia and the fibula are broken. This would alleviate the~     need for another incision, plate, and screws to repair the fibula. The purpose of this study~     is to help determine if surgically repairing only the tibia fracture will lead to equivalent~     clinical outcomes when compared with surgical repair of both bones.~      The hypothesis of this study is that operative stabilization of the medial malleolus fracture~     only, in otherwise ligamentously stable bimalleolar and/or trimalleolar fractures of the~     ankle, will lead to equivalent clinical outcomes and functional scores as those treated with~     operative stabilization of both malleoli and/or all malleoli.~   "
117238|NCT02032953|"~     The purpose of this study is to find out whether adding insulin after current colorectal~     cancer surgery promotes making and keeping proteins in the body, and to find out whether or~     not this effect can be further increased by increasing the amount of protein given.~   "
117239|NCT02032940|"~     The purpose of the study is to create MR images using an investigative technique called pulse~     sequences with new computer software programs. The sequence will allow us to image vessels~     without injecting contrast agents.~   "
117240|NCT02032927|"~     Osteoarthritis is a common joint disorder in the elder population.The current treatment~     options include both a non-pharmacological approach (physiokinesitherapy, diet) or if this~     fails, a pharmacological approach that relies in the first instance on drugs such as~     paracetamol, non-steroidal anti-inflammatory (including inhibitors of cyclo-oxygenase).~     However, the use of these drugs is limited, by the roof effect concerning analgesia, and by~     the potential side effects. When pharmacological treatments with non-opioid medications fail,~     and a moderate-to-severe pain reduces the quality of life of the patient, international~     guidelines suggest the use of opioid drugs.~   "
117241|NCT02032914|"~     Although a proportion of pyogenic liver abscess may originated from colonic mucosal lesions,~     the prevalence of colonic neoplasm in the patients with pyogenic liver abscess are still not~     evaluated yet. Thus, our group will find the prevalence of colonic neoplasm in the group of~     cryptogenic pyogenic liver abscess by colonoscopic examination.~   "
117242|NCT02032901|"~     To study the combination of Daclatasvir and Sofosbuvir for the treatment of hepatitis C virus~     (HCV) Genotype 3 infection~   "
117243|NCT02032888|"~     A study of the efficacy and safety of the combination of daclatasvir and sofosbuvir in the~     treatment of hepatitis C virus and HIV coinfection.~   "
117244|NCT02032875|"~     This trial was open to participants who had received a liver transplant or had cirrhosis due~     to chronic HCV. All subjects were treated with daclatasvir+sofosbuvir+ribavirin and were~     followed for 24 weeks post treatment. Under certain conditions, the treatment duration could~     have been extended for cirrhotic participants. The study tested the efficacy and safety of~     this combination for treatment of HCV in cirrhotic and post transplant patients.~   "
117245|NCT02032862|"~     Sage tablets ( 3400 mg extract from fresh sage leaves, DER 1:17) in a once daily application~     over 12 treatment weeks are compared against placebo in 200 menopausal patients with ≥ 5 hot~     flushes daily and a Hyperhidrosis Scale score ≥ 2~   "
117246|NCT02032849|"~     This is a randomized controlled trial compared two methods to drainage subglottic secretion~     in prolonged intubated patients.After enrolled, patients are randomized assigned to~     intermittent subglottic secretion drainage group and air-impingement manipulation group.~   "
117247|NCT02032836|"~     Administration of iloprost aerosol comparing two nebulizers: FOX and I-Neb~   "
117248|NCT02032823|"~     Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative~     primary breast cancer who have completed definitive local treatment and neoadjuvant or~     adjuvant chemotherapy~   "
117249|NCT02032810|"~     The purpose of this study is to find out if an investigational drug called panobinostat can~     be given safely with another drug called ipilimumab. Investigators want to learn more about~     the side effects of this combination of drugs using different doses of panobinostat and the~     same dose of ipilimumab.~   "
117255|NCT02032732|"~     Pediatric joint infections are a common diagnostic dilemma encountered by treating~     orthopaedic surgeons. No single test is sensitive or specific enough to stand alone in~     determining the presence of joint infection.~      The purpose of this study is to test the usefulness of a chemical test strip to detect~     infection in fluid that is removed from a joint (intra-articular aspiration) in pediatric~     patients. The test strip measures an enzyme called leukocyte esterase, which has been shown~     to be useful in detecting the presence of infection in fluids from other parts of the body.~     This study will assess the efficacy of the leukocyte esterase test as a diagnostic tool for~     evaluating pediatric joint infections. The hypothesis of the study is that a positive~     leukocyte esterase test identifies a septic joint in pediatric patients undergoing~     intraoperative joint aspiration.~   "
117256|NCT02032719|"~     Patients who receive smartphone-assisted health coaching will have a significantly lower 24~     hour ambulatory blood pressure mean than patients who receive just health coaching~   "
117257|NCT02032706|"~     The purpose of this study is to assess the accuracy of Night Shift in the detection of supine~     sleep and efficacy of vibro-tactile feedback in restricting supine sleep.~   "
117258|NCT02032693|"~     The investigators are conducting this research because they want to determine if a dietary~     supplement, called Everycell™, has an effect on the functioning of the study participants'~     cells. The results of this research will be used to help develop additional strategies for~     trying to fight the effects of aging. The primary purpose of this study is to determine the~     effectiveness of Everycell™ compared to placebo (a pill that does nothing) on DNA damage,~     inflammation, stress, and related factors. Taking Everycell™ is not a medical prescription,~     treatment, or cure for any known disease or condition.~      Helping patients' nutritional status is important to prevent the continued worsening of~     chronic diseases and also to counteract the effects of aging. Americans also have~     difficulties with compliance to prescription medications due to their toxicity and side~     effects. This study aims to learn more about how a dietary supplement may improve nutritional~     status and enable the body to normalize cellular functioning, which may improve quality of~     life. The results of this research will be used to determine if Everycell™ is beneficial for~     overall cellular health and to counteract the effects of aging.~   "
117259|NCT02032680|"~     As specified in the VA Uniform Services Handbook, Family Psycho-Education (FPE) treatment~     must be available to all Veterans with schizophrenia who could benefit, and their family~     members. This includes those receiving care at Community Based Outpatient Clinics (CBOCs),~     and at Psychosocial Rehabilitation and Recovery Centers (PRRCs), whether provided on site, by~     referral, or by telemental health. However, less than 5% of VA medical centers offer FPE.~     Clearly, a major challenge is to devise ways to deliver mental health treatments and services~     to Veterans who need them in ways that meet their needs and preferences. The proposed project~     will compare the use of a website to deliver FPE to that of in-person delivered FPE. The~     findings could have profound implications for the VA's ability to improve the reach, use,~     appeal, and effectiveness of FPE for Veterans with schizophrenia, by using an e-health model~     that facilitates family involvement.~   "
117260|NCT02032667|"~     This study will be investigating an innovative and exciting way to increase physical activity~     in children between the ages of 9 and 12 years old. Families will be provided with a~     state-of-the-art exercise bike and video game console to have in their homes. The video games~     will provide a variety of play including racing, puzzle solving, collaborative play, team~     play and competitive play. We will be comparing whether a 'multi-player' condition has a~     greater adherence compared to a 'single-player' condition.~   "
117261|NCT02032654|"~     Cellulitis is among the most common infections leading to hospitalization, yet the optimal~     duration of therapy remains ill defined. Pragmatically, Dutch guidelines advise 10-14 days of~     antibiotics, which is the current standard of care. Recently it has been shown that~     antibiotic treatment for pneumonia and urinary tract infections can safely and significantly~     be shortened. Importantly, in an outpatient setting, treatment of uncomplicated cellulitis~     with 5 days of antibiotics was as effective as 10 days. We hypothesize that there is no~     difference in outcomes when patients hospitalized with cellulitis are treated with either a~     short-course (6 days) or standard-course (12 days) of antibiotics.~   "
117262|NCT02032641|"~     The purpose of this study is to determine the efficacy of the 1064nm Neodymium yttrium~     aluminum garnet (Nd:YAG) laser (Laser Genesis, Cutera TM) in the treatment of surgical scar~     after direct brow lift.~   "
117263|NCT02032628|"~     Specific aim 1. Using a fully crossed 2 (intensity) X 2 (duration) design, the investigators~     will demonstrate a dose-response relationship between volume of aerobic exercise and changes~     in DNA methylation over four months among previously sedentary women.~      Specific aim 2. There are no published data on the extent to which positive effects of~     exercise on methylation might decay if exercise is not continued. The investigators will~     gather data on the natural history of methylation decay after training.~   "
117264|NCT02032615|"~     To test the efficacy of Gudness Bars in improving the hemoglobin and hematocrit levels of~     anemic subjects longitudinally.~      To quantify the demographics of subjects attending anemia testing camps through LBWR and to~     explore correlations with the demographics data.~   "
117265|NCT02032602|"~     Background: Non-specific shoulder pain has a high prevalence in older adults and provokes~     functional alterations. Besides, there are difficulties for its clinical diagnosis, lack of~     effectiveness in the treatment and not much evidence is found regarding invasive physical~     therapy techniques in this population.~      Purpose: To determine the efficacy of a single physical therapy intervention with deep dry~     needling on latent and active myofascial trigger points in older adults with non-specific~     shoulder pain.~      Methods: Pilot Study, Single Blind Randomized Controlled Clinical Trial on 60 subjects aged~     65 and over, will be diagnosed with nonspecific shoulder pain. The study will be approved by~     the Clinical Research Ethics Committee of the area. Sample will be recruited at their home~     and at a care center, and randomly will be distributed in Experimental Group (n=30), which~     will be received a session of Deep Dry Needling on an active and a latent Myofascial Trigger~     Points of the infraspinatus muscle; and Control Group (n=30), receiving a session of Deep Dry~     Needling only on an active Myofascial Trigger Point. A blind examiner will be evaluated Pain~     Intensity, Pain Pressure Threshold (anterior deltoid; extensor carpi radialis brevis) and~     Grip Strength, before, immediately after intervention and after a week of treatment.~   "
117266|NCT02032589|"~     Past research has shown that items self-generated by an individual, such as words or~     concepts, are remembered better than items that are simply read or heard. The current study~     seeks to demonstrate the effectiveness of using the principles of the generation effect in a~     treatment intervention to improve memory and functional performance in individuals with~     Multiple Sclerosis who have learning and memory difficulties.The main purpose of the study is~     to conduct an experimental investigation on the effects of a self-generation strategy~     treatment, embedded within practice of various activities ranging from laboratory tasks (e.g.~     words and concepts) to functional tasks (e.g. activities of daily living). The treatment to~     be tested is geared toward helping patients selfdiscover their own strengths and abilities~     while using self-generation to be able to utilize it independently in everyday life~     situations.~      Design: The proposed pilot study is a randomized clinical trial. Participants: Participants~     will include forty (40) persons with MS, between the ages of 18 and 65, who demonstrate~     memory impairments. Half of the participants will receive the self-generation training while~     learning different types of tasks (experimental group) and half of the participants (control~     group) will be asked to learn the same information but will receive a conventional practice~     (e.g. repetitions).~      Expected results: We expect that participants undergoing the self-generation-training~     intervention will show better memory performance, functional performance, quality of life,~     and satisfaction with treatment and life compared to participants in the control condition.~   "
117267|NCT02032576|"~     Objective: Psychiatrists have long sought a quantifiable biomarker of electroconvulsive~     therapy (ECT) response. Although ECT is highly effective for treatment of patients with major~     depressive episode, a high rate of relapse/recurrence is a major problem after~     discontinuation of ECT. The purpose of this study is to examine the factors related to the~     response of ECT, to predict ECT response early, and to investigate the clinical predictors~     affecting the time to relapse/recurrence after ECT.~      Methods: Patients with major depressive episode who require ECT treatment will be enrolled.~     ECT will be performed regularly. The 17-item Hamilton Rating Scale for Depression (HAMD-17)~     and other scales will be assessed before ECT, after every 10 days, till to an expected~     average of 50 days, and monthly during the 6-month follow-up period. Other measures also will~     be performed before the first ECT, at an expected average of 50 days, and at the end of~     follow-up period. Predictors of the response and relapse/recurrence after ECT and early~     prediction of ECT response will be obtained by statistic methods.~   "
117268|NCT02032563|"~     We will verify if IV injected ICG may colour breast tumors and axillary lymph nodes after~     neoadjuvant therapy (chemo- or hormonotherapy)~   "
117269|NCT02032550|"~     The purpose of this study is to develop a preference based decision aid to assess the~     treatment preferences of prostate cancer patients, and to analyze the interaction of~     treatment preferences, type of treatment received and their relationship with health related~     quality of life, satisfaction with care, decision regret, and psychological health of men~     with localized prostate cancer.~   "
117270|NCT02032537|"~     Uraemic pruritus (UP) remains a frequent and distressing problem in patients with advanced~     chronic kidney disease (CKD) and end-stage renal disease (ESRD).~      Calmmax is a new topical cream that was introduced recently by Calmmax Pharma, an Israeli~     pharmaceutical company developed a topical cream based on active plant extracts for treatment~     of skin inflammation. We intend to conduct a prospective, double blind, placebo controlled,~     randomized trial that will assess the therapeutic effect of Calmmax cream on UP in a cohort~     of CKD and ESRD patients.~   "
117271|NCT02032524|"~     Primary Objective:~      Long-term safety and pharmacokinetics (PK) of neoGAA~      Secondary Objective:~      Long-term effect of neo-GAA on pharmacodynamic and exploratory efficacy variables~   "
117272|NCT02032511|"~     This study is designed to compare the effectiveness and ease of use of two commonly used~     NCPAP interfaces: the RAM NC and the Infant Flow prongs and nasal mask.~   "
117273|NCT02032498|"~     The revision of our data shows that since its introduction in our institution (Jules Bordet~     Institute) in 1998 (until 2010, the year of the last review of cases), 53 patients underwent~     neoadjuvant therapy before selective sentinel lymph node dissection followed by conventional~     axillary dissection.~      The analysis of these cases shows that:~        -  The lack of demonstration of sentinel lymph nodes observed in 8 cases (6 cN0) is~          associated in 75% of them with a pN+ status~        -  If scintigraphic imaging is positive (demonstration of the sentinel lymph nodes: 35~          cN0 and 10 cN+), our results appear favorable with a single false negative SLN result~          (False Negative Rate = 1/20 or 5%).~      Therefore we propose additional technique for LN detection by indocyanine green, we~     hypothesize that the combination of two different injections improves the technique of~     sentinel lymph node biopsy.~   "
117274|NCT02032485|"~     The purpose of this study is to determine if Near-Infrared fluorescence imaging is an~     effective approach to detect the colorectal tumoral tissues and peritoneal implants in~     colorectal cancer patients.~   "
117275|NCT02032472|"~     Background: Hypertension in adults is the factor most prevalent cardiovascular risk and~     motivates further inquiries, generating a very high cost of medical care.~      Objective: To evaluate the monitoring of well-controlled hypertensive patients Pharmacy~     Offices. Hypothesis: the monitoring of these patients through the Office of Pharmacy will be~     as effective in obtaining good control of blood pressure as it is to obtained through health~     centers. Design: Multicenter randomized controlled trial along one year of follow up.~     Location: the city of Cerdanyola del Vallès (Barcelona). Participants: All patients diagnosed~     with hypertension and good control criteria in the past year. Arms: Health centers (control)~     and Pharmacy Offices (intervention). Outcome variable: blood pressure under good control~     along the monitoring~   "
117287|NCT02032316|"~     A prospective, single-center, single-arm, trial to demonstrate safety and device performance~     of the ADVA-Tec Uriprene™ Degradable Temporary Ureteral Stent. This is a first-in-man~     clinical study in a small human population.~   "
117356|NCT02031419|"~     First study, at multiple clinical centers, exploring the effects of different combinations of~     compounds (CC-122, CC-223 ,CC-292 and rituximab) to treat Diffuse Large B Cell Lymphoma~     (DLBCL) and Follicular Lymphoma~   "
117912|NCT02024152|"~     This study is to investigate the pharmacokinetics (PK) together with the safety and~     tolerability of JDP-205 at 5 mg and 10 mg intravenous doses and 10 mg intramuscular dose, in~     comparison to the marketed cetirizine oral product Zyrtec® 10 mg tablets (an OTC product) in~     healthy male and female volunteers after a single dose administration.~   "
117276|NCT02032459|"~     Vitamin D is present in food either naturally or by fortification and included in nutritional~     supplements. It is also synthesized photochemically by the skin from ultraviolet B radiation.~     Vitamin D synthesis varies by season and with latitude as well as according to intensity of~     skin pigmentation. Recent research in the United States found lower circulating levels of 25~     (OH) D, the primary indicator of vitamin D status, among minority women who were either~     pregnant or in their reproductive years. The extent to which maternal vitamin D has an~     influence on the course and outcome of human pregnancy remains to be more completely studied.~     We propose to use the HPLC method to assay cholecaliferol (vitamin D3) and ergocalciferol~     (vitamin D2) to assess maternal vitamin D status. This will be accomplished by analyzing~     existing fasting samples and data derived from the 2001-2006 cohort (N=1141) of young, low~     income minority gravidae from Camden, New Jersey to determine:~        1. The prognostic importance of maternal vitamin D status for birth weight, gestation~          duration and poor pregnancy outcomes (low birth weight, preterm delivery, fetal growth~          restriction).~        2. The relation of maternal vitamin D status to important complications of pregnancy~          (gestational diabetes and pre-eclampsia).~        3. The relationship of maternal vitamin D status to maternal diet and supplement use,~          season of year, ethnicity, overweight/obesity, and other maternal characteristics.~   "
117277|NCT02032446|"~     MESENCHYMAL STROMAL CELLS (MSC) have shown promising albeit not always consistent therapeutic~     effects in the treatment of severe steroid-resistant acute Graf versus Host Disease.~     Remarkably, in all reported clinical studies the toxicity of Mesenchymal stromal cells~     administration has been found consistently negligible. The investigators believe that~     Umbilical Cord (UC) derived Mesenchymal stromal cells may represent a stronger~     immunosuppressive tool for such clinical emergency and no data suggest any change in the~     safety profile of these cells. For this reason, and in the best interest of the patient, the~     investigators plan to test the safety and activity of Umbilical Cord Mesenchymal stromal~     cells when given sequentially to another partially effective treatment of steroid resistant~     acute graf versus host disease such as Pentostatin.~   "
117278|NCT02032433|"~     CTN-0051 assesses the comparative effectiveness of extended release injectable naltrexone~     (XR-NTX, Vivitrol®), an opioid antagonist recently approved and indicated for the prevention~     of relapse to opioid dependence, versus buprenorphine-naloxone (BUP-NX, Suboxone®), a high~     affinity partial agonist indicated for maintenance treatment of opioid dependence, as~     pharmacotherapeutic aids to recovery.~      The study is conducted in 8 NIDA Clinical Trials Network affiliated community based treatment~     programs. Up to 600 eligible participants will be randomized to treatment with XR-NTX or~     BUP-NX for 24 weeks (sufficient to include 350 participants who are randomized more than 72~     hours after their last opioid).~      The primary goal of the study is to estimate the difference, if one exists, between XR-NTX~     and BUP-NX in the distribution of the time to relapse (i.e.., loss of persistent abstinence)~     during the 6-month trial. Secondary objectives are to: (1) compare outcome on XR-NTX versus~     BUP-NX across a range of clinical safety and secondary efficacy domains, and (2) explore~     demographic and, clinical, and genetic predictors of successful treatment and moderators of~     differential effectiveness (i.e., what variables may help clinicians choose which of these~     treatments is best for a given patient).), and (3) collect a limited dataset to permit~     analyses of economic costs and benefits of the two treatments.~   "
117279|NCT02032420|"~     Volunteers will watch a training video demonstrating how to place a needle in the correct~     position while keeping it visible. Later the volunteers will be placed in front of a set up~     identical to the video, and asked to demonstrate how to direct an 80 mm echogenic Pajunk~     needle into 3 targets in a standardized homemade phantom a total of three times.~   "
117280|NCT02032407|"~     This study will evaluate the effect of dapsone gel in female subjects with skin of color~     (Fitzpatrick Skin Types IV, V, and VI) with acne vulgaris.~   "
117281|NCT02032394|"~     This study is conducted to determine and compare the effect of applying Povidone-iodine and~     Chlorhexidine solutions for perinea washing on bacteriuria rate and type in patients with~     urinary catheter in intensive care unit.~   "
117282|NCT02032381|"~     Hematopoietic stem cell transplantation (HSCT) is used to treat an expanding array of~     malignant and non-malignant disorders. This is a prospective multicenter study, in pediatric~     allo-BMT recipients to analyze the spectrum of noninfectious pulmonary complications (PC), to~     evaluate the prevalence and course of PFT abnormalities before and after transplant, and to~     detect risk factor for PC.~   "
117283|NCT02032368|"~     Circulating tumour cell (CTC) count could reflect the effect of postoperative transarterial~     chemoembolization (TACE) on hepatocellular carcinoma (HCC) recurrence.~   "
117284|NCT02032355|"~     Maternal hypotension is a common side effect after spinal anesthesia for cesarean~     delivery.Decreased vascular resistance and cardiac output, due to sympathetic blockade1and~     blood pooling in blocked areas of the body respectively, are main causes of spinal~     anaesthesia-induced hypotension during Caesarean delivery.~      Cardiac output, which has shown to be a better predictor of organ and placental perfusion~     than arterial blood pressure.Few studies have measured CO after spinal anesthesia in the~     maternal population.This is largely because of the lack of availability of accurate and~     reproducible noninvasive measurement techniques. Up to now, preventing hypotension has~     continued to focus on arterial blood pressure variables, fluid, and ephedrine requirements as~     markers of cardiovascular status, because these are more easily measured.~      Investgators hypothesized that CO and PetCO2, in parturients with the degree of hypotension~     during spinal anaesthesia, would also have a positive and significant association.~   "
117285|NCT02032342|"~     Selective lobar blockade (SLB) is a specific technique that allows collapse of the operated~     lobe during thoracic surgery while the other lobes are ventilated. It is associated with the~     improvement of arterial oxygenation during one lung ventilation (OLV) for thoracic with~     providing adequate surgical access. The purpose of this study is to compare the efficacy of~     three bronchial blockers, namely an Arndt® wire-guided endobronchial blocker, a Cohen~     Flexi-tip endobronchial blocker or a Fuji Uni-blocker, for achieving selective lobar~     collapse.~   "
117286|NCT02032329|"~     The purpose of this study is to assess efficacy of a pre-commercial device capable of~     activating both the ankle plantarflexor and dorsiflexor muscles using electrical stimulating~     during treadmill-based gait training for stroke patients.~   "
117288|NCT02032303|"~     Study design Investigators aim to perform a prospective, single-center,~     investigator-initiated, randomized study to compare the Adenosine-induced coronary~     vasodilatation after the loading dose of Ticagrelor either Prasugrel during the Percutaneous~     Coronary Intervention. Patients with acute coronary syndrome undergoing Percutaneous Coronary~     Intervention will be enrolled in the study and will be randomized, in a 1:1 ratio, to receive~     a loading dose of Ticagrelor (180 mg) or Prasugrel (60 mg). In patients with non-ST elevation~     myocardial infarction these drugs will be administered only when the coronary anatomy will be~     known, to avoid bleeding due to prasugrel, in patients suitable for coronary artery bypass~     grafting as recommended by European Society of Cardiology guidelines (Class IB) (10). In~     patients with ST elevation myocardial infarction, instead, prasugrel and ticagrelor will be~     administrated before the procedure, according to the European Society of Cardiology~     guidelines (Class IB) (11). Coronary Flow Reserve will be recorded by intracoronary Doppler~     Flow Wire before the stent implantation and after the procedure at baseline and 2-minute~     later adenosine intravenous administration at incremental doses of 50, 80, 110 and 140~     ug/Kg/min with 2 minutes interval between infusions.~      Coronary Flow Reserve is the ability of the myocardium to increase blood flow in response to~     maximal exercise. Doppler Flow Wire allows to measure this increase expressing it as a ratio~     between maximal vasodilation and flow at rest. Coronary Flow Reserve is routinely measured in~     patients with acute coronary syndrome, without an increased risk of adverse events for~     patients neither adjunctive costs for the National Health System.~      Furthermore, Plasma concentrations of Ticagrelor and its main metabolite (AR-C124910XX) will~     be measured in venous blood collected at the end of the procedure. . In patients requiring a~     second Percutaneous Coronary Intervention, for example for multivessel disease, all these~     measures will be repeated in the same manner.~   "
117289|NCT02032290|"~     The administration of these drugs is realized according to the European Society of Cardiology~     guidelines.~      All patients will be pretreated with aspirin 300 mg orally, heparin iv to maintain an~     activated clotting time of >250 sec, and a loading dose of ticagrelor (180 mg) or clopidogrel~     (600 mg) immediately before the revascularization. The list of assignment to ticagrelor or~     clopidogrel will be generated by a computer according to a 1:1 randomization. Primary~     Percutaneous Coronary Intervention will be performed according to standard clinical practice~     using femoral or radial artery Judkins approach via six or seven French heath insertion.~     After crossing the target occlusive Lesion, coronary stenting will be performed based on~     standard practice. Patients subsequently will receive heparin for 48 hr, aspirin 100 mg~     daily, and clopidogrel (75 mg/day) or ticagrelor (90 mg twice daily) for at least 12 months.~     Other adjunctive pharmacotherapy in Intensive Care Unit will be administered according to~     operator discretion. All patients will provide written informed consent before entering the~     study.~      Before and after the procedure a 12-leads ECG and an echocardiogram will be performed as~     standard practice. Then, all the pre-, intra-, and post-procedure data patients will be~     collected in a database.~      Investigators aim to perform a prospective, single-center, investigator-initiated, randomized~     study to compare the Adenosine-induced coronary vasodilatation after the loading dose of~     Ticagrelor either Clopidogrel during the Percutaneous Coronary Intervention. Patients with~     Acute Coronary Syndrome undergoing Percutaneous Coronary Intervention will be enrolled in the~     study and will be randomized, in a 1:1 ratio, to receive a loading dose of Ticagrelor (180~     mg) or Clopidogrel (600 mg). Coronary Flow Reserve will be recorded by intracoronary Doppler~     Flow Wire before the stent implantation and after the procedure at baseline and 2-minute~     later adenosine intravenous administration at incremental doses of 50, 80, 110 and 140~     ug/Kg/min with 2 minutes interval between infusions.~      Coronary Flow Reserve is the ability of the myocardium to increase blood flow in response to~     maximal exercise. Doppler Flow Wire allows to measure this increase expressing it as a ratio~     between maximal vasodilation and flow at rest. Coronary Flow Reserve is routinely measured in~     patients with Acute Coronary Syndrome, without an increased risk of adverse events for~     patients neither adjunctive costs for the National Health System.~      Furthermore, Plasma concentrations of Ticagrelor and its main metabolite (AR-C124910XX) will~     be measured in venous blood collected at the end of the procedure. In patients requiring a~     second Percutaneous Coronary Intervention, for example for multivessel disease, all these~     measures will be repeated in the same manner.~   "
117290|NCT02032277|"~     This is a 3 arm Phase 3 study to evaluate the safety and efficacy of the addition of~     veliparib plus carboplatin versus the addition of carboplatin to standard neoadjuvant~     chemotherapy versus standard neoadjuvant chemotherapy in subjects with early stage TNBC.~   "
117291|NCT02032264|"~     To evaluate the benefits of using next generation sequencing to assess embryonic aneuploidy.~     All viable blastocysts will be biopsied and cryopreserved for future transfer. After the~     final embryo is cryopreserved, patients will be randomized to either the intervention group~     or the control group. Patients and doctors are blinded to the randomization until study~     completion. A Double Embryo Transfer (DET) will be performed with either screened or~     unscreened embryos depending on randomization. A Single Embryo Transfer (SET) may occur in~     cases where only one embryo is available for transfer.~   "
117292|NCT02032251|"~     This study is a randomized, double blind, controlled clinical trials assess the efficacy of~     the ginger oral treatment on sperm DNA fragmentation, sperm parameters and male hormones.~   "
117293|NCT02032238|"~     Asses efficacy of navigated laser in reducing the number of anti-VEGF injections as a~     prospective study using Bevacizumab.~   "
117294|NCT02032225|"~     Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leucoencephalopathy~     (CADASIL) is an archetypal small vessel disease of the brain caused by dominant mutations in~     the NOTCH3 receptor. Cardinal vascular lesions include deposition of granular osmiophilic~     material (GOM) within the basal lamina of smooth muscle cells, progressive smooth muscle cell~     loss, and fibrosis of the media. Pathogenic mutations alter the number of cysteine residues~     in the extracellular domain of NOTCH3 (Notch3 ECD), leading to its abnormal accumulation in~     the GOM deposits. Vascular smooth muscle cell has been identified as the primary target cell~     in this disease. Pathophysiological processes leading from NOTCH3 mutations to smooth muscle~     cell loss remain poorly understood.~      The investigators propose to study these mechanisms by reprogramming skin cells to become~     stem cells and then differentiating them to vascular smooth muscle cells.~      The hypothesis of this study is that the differentiated smooth muscle cells will display the~     characteristic features of CADASIL, ie, Notch3 ECD accumulation and GOM deposits.~   "
117295|NCT02032212|"~     Electronic Vapour Products (EVPs) are a relatively new class of consumer products that are~     otherwise known as electronic cigarettes. These may look like conventional cigarettes but do~     not contain tobacco.~      The 'vapour' produced by such devices typically consists of humectants (propylene glycol or~     glycerol), nicotine, water, and flavours.~      This trial is to evaluate the pharmacokinetic profile of an EVP.~   "
117296|NCT02032199|"~     A central goal of health care is to maximize patient functioning and well-being. This has~     prompted measurement of health-related quality of life (HRQOL) that encompasses physical,~     psychological, and social functioning. While obese people have generally impaired HRQOL,~     people seeking bariatric surgery for obesity appear to have poorer HRQOL than obese~     individuals seeking non-surgical treatment or obese individuals not seeking weight-loss~     treatment. HRQOL improves significantly after bariatric surgery, but often with large~     individual variations in outcome. As gastric bypass is an invasive procedure with~     irreversible influences on eating behaviour and possible serious adverse events, it is~     important to identify potential risk factors for a poorer long-term result. In Denmark,~     bariatric surgery is free of charge for patients fulfilling the Danish Health and Medicines~     Authority guidelines, which until 2011 were in line with international guidelines. However,~     in 2011 access to surgery was dramatically restricted and the annual number of operations~     reduced from 0.9 per 1000 inhabitants (2010) to 0.2 per 1000 inhabitants (2012). The~     restrictions involved a tightening of the criteria for patients without manifest obesity~     comorbidities, raising lower body mass index (BMI) threshold from 40 to 50 and increasing the~     lower age limit from 18 to 25 years (11). It is not known whether patients fulfilling the~     tighter criteria benefit more from surgery than patients who only met the previous criteria.~      This study assessed HRQOL changes associated with Roux-en-Y gastric bypass with follow-up~     over an average of 22 months. The aim was to explore whether postoperative HRQOL variations~     were associated with identifiable socio-demographic or clinical characteristics. In~     particular, whether HRQOL changes differed for patients fulfilling the current Danish~     criteria and patients only fulfilling the previous criteria.~   "
117297|NCT02032186|"~     The investigators propose a preventive strategy that may reduce the risk of placental~     vascular disease and its negative consequences for both the fetus (e.g., poor fetal growth or~     stillbirth)and mother (e.g., the hypertensive disorders of pregnancy), and which, in turn,~     should reduce the need for indicated preterm delivery. This strategy is a multicenter,~     randomized double-blind, placebo-controlled clinical trial (RCT) comparing magnesium citrate~     supplementation with placebo, each starting at 12 to 20 weeks gestation and continued until~     delivery. Magnesium citrate is a safe and inexpensive compound that is easily absorbed by the~     intestinal tract. The results of this RCT may be especially relevant in low and middle income~     countries that have high rates of prematurity, and limited resources for acute newborn and~     maternal care.~   "
117298|NCT02032173|"~     To evaluate a new treatment regimen with a spaced out follow-up after an initial intensive~     treatment phase in patients with reduced visual acuity due to diabetic macular edema (DME).~   "
117299|NCT02032160|"~     The purpose of this study is to generate an exploratory training set of data and to identify~     predictive biomarkers (a measurable biological response that predicts something) of innate~     and adaptive responses to immunisation of two vaccines utilizing different adjuvant~     technology given according to approved schedules to healthy adult volunteers. The vaccines~     are model agents selected as they match antigens but have discordant adjuvants, have a known~     immunogenicity profile, assays are freely available to measure responses, and they are safe~     to administer to healthy adults at the doses and schedules proposed. This study will strive~     to correlate biomarker activity with observed immunological responses to vaccination and if~     successful, these biomarkers could be used in early stage clinical trials to optimize~     selection of vaccine candidates with a profile that will be most likely to be effective once~     they are in generalized use.~   "
117300|NCT02032147|"~     Cerebral radiation necrosis (CRN) is a well-documented late complication of radiation therapy~     for cancers, and may have a devastating effect on the patient's quality of life (QOL).~     However,CRN was once regarded as a progressive and irreversible disease, no standard therapy~     has been suggested for CRN. In our clinical practice, we have used nerve growth factor(NGF)~     to treat CRN, and found that GM1 can successfully reverse CRN. A case report has been~     published in Journal of Clinical Oncology (JCO) in 2011. So we carried out this prospective~     study to test the efficacy of NGF for CRN.~   "
117301|NCT02032134|"~     The increasing need for blood components and the increasingly careful donor selection~     procedures, make the availability of blood components very reduced, in particular for~     platelets that are currently administered preferably fresh or cryopreserved, only in~     emergency conditions.~      Exceeding this limit through the spread of use of cryopreserved platelets in the common~     clinical practice, might help clinicians to avoid wasting valuable products and face periods~     of particular shortage of donors Some studies already published in the literature over the~     last decade (1,2) have demonstrated the safety and efficacy of autologous cryopreserved~     platelets .~      The main objective of the proposed study is to evaluate the efficacy and safety of platelets,~     cryopreserved with DMSO using a a new method, in patients with severe thrombocytopenia.~      This is the in vivo phase of a study where availability and efficacy of cryopreserved~     platelets has been assessed in vitro.~   "
117302|NCT02032121|"~     Survivors of childhood cancer have an increased risk of death from cardiovascular disease due~     to both the therapies they received while undergoing treatment and diet and lifestyle~     factors. The nature of cardiovascular risk and the interaction between treatment affects and~     cardiovascular risk factors is unknown. We propose to study vascular inflammatory markers as~     well as measure of blood vessel stiffness (both of which are predictive of early heart~     disease) in 100 pediatric cancer survivors and 100 control children. Characterization of~     vascular inflammation and stiffness in long-term survivors will allow for the development of~     future interventions to decrease inflammation through both pharmacologic and lifestyle~     modifications.~   "
117303|NCT02032108|"~     Strategies to reduce the burden of diabetes in Rwanda, like in other resource poor settings,~     include involving diabetic patients in their own care and targeting modifiable risk factors~     through adopting appropriate dietary and lifestyle habits. According to previous research~     carried out in developed countries, lifestyle modifications may have effect on the~     development of diabetes and prevention of its complications.~      However, direct evidence to show whether lifestyle intervention is beneficial for diabetic~     patients in resources limited countries like Rwanda is an open question. Though in these~     countries, access to healthy diet is claimed to be the barrier of implementation of~     therapeutic lifestyle based initiatives, we hypothesize that knowledge gaps are more~     important barriers than access to healthier diets and other lifestyle habits. We therefore~     would like to carry out this intervention to assess the effects of lifestyle education~     programs on glycemic control among people with diabetes followed up at CHUK.~   "
117304|NCT02032095|"~     It is intended to examine the safety and efficacy of desensitization therapy by GB-0998~     (intravenous immunoglobulin) for the anti-donor antibody positive recipient in need of~     pre-transplant desensitization. Patients with positive FCXM-T after performing twice double~     filtration plasmapheresis (DFPP) therapy will receive GB-0998 1g/kg/day for four days.~   "
117313|NCT02031978|"~     The goal of the study is to be a current examination of infant and toddler feeding practices~     among families receiving WIC services. It has been more than 10 years since the last study of~     such feeding practices, and in the interim important changes have taken place in the WIC~     program, in society, and in the science of nutrition. The study will include exploration of~     breastfeeding practices and support, more general feeding practices, nutritional intake of~     infants and toddlers, transitions in infant and toddler feeding practices, early precursors~     of obesity, and family factors that may influence all of these nutrition-related issues. It~     will also explore characteristics of the WIC program in selected sites, and how these relate~     to infant and toddler feeding decisions and practices. This study is important both to update~     knowledge about the WIC population, and to uncover possible new avenues of inquiry regarding~     early childhood obesity.~   "
117314|NCT02031965|"~     This phase I trial studies the side effects and the safety of injecting HSV1716 (a new~     experimental therapy) into or near the tumor resection cavity. The injection will be done at~     the time of surgery. HSV1716 is a virus that has a gene which has been changed or removed~     (mutated) in such a way that lets the virus multiply in dividing cells of the tumor and kills~     the tumor cells.~   "
117305|NCT02032082|"~     Ex vivo lung perfusion (EVLP) is not a new concept and has been widely used to study lung~     function in small animals. It also has been shown to be a useful technique to evaluate lungs~     from donation after cardiac death (DCD) (Yeung, Thorac Surg Clin, 2009). It has been recently~     demonstrated successful application of an acellular EVLP technique in optimalizing lung~     function ex vivo for an extended period of time. Following 12 h of normothermic EVLP,~     patients were transplanted and demonstrated immediate life-sustaining function with promising~     short-term evolution (Aigner, Am J Transplant, 2012; Sanchez, J Heart Lung Transplant, 2012;~     Cypel, N Engl J Med, 2011).~      Lung donation obtained after carbon monoxide intoxication has been recognized as excellent~     organs because of less general inflammation and less primary graft dysfunction after~     procedure. In a murine model of brain dead, carbon monoxide inhalation at a low concentration~     (50 to 500 parts per million (ppm)) exerts significant cytoprotection in several lung injury~     models via its vasodilatation, anti-inflammatory, and anti-apoptotic properties (Dong, J~     Heart Lung transplant, 2010). The carbon monoxide inhalation down-regulates pro-inflammatory~     cytokines (TNF-alpha, IL-6) along with the increase of anti-inflammatory cytokine (IL-10) in~     recipient serum. The inhalation significantly decreases cell apoptosis in lung grafts,~     inhibiting mRNA and protein expression of intercellular adhesion molecule-1 (ICAM-1) and~     caspase-3 in lung grafts (Zhou, Chin Med J, 2008).~      Apoptotis and inflammatory processes may, in part, concern alveolar tissue. Research in the~     field of biomarkers is now opening new perspectives with the development of non-invasive~     tests allowing for monitoring inflammation and damage in the deep lung. Blood tests (Bernard,~     Toxicol Appl Pharmacol, 2005) measuring lung-specific proteins (pneumoproteins) such as Clara~     cell protein (CC16) and surfactant-associated proteins (A, B or D) are now available to~     evaluate the permeability and/or the cellular integrity of the pulmonary epithelium. These~     dosages may constitute an interesting way for monitoring the quality of the lung before~     implantation.~   "
117306|NCT02032069|"~     Primary graft dysfunction, a form of reperfusion pulmonary edema that occurs early after lung~     transplantation, shares key clinical and pathological features with acute lung injury and its~     more severe form, the acute respiratory distress syndrome. However, in contrast to acute lung~     injury/acute respiratory distress syndrome, in which biomarkers in plasma, urine and lung~     edema fluid have prognostic and pathogenetic value, the role of biomarkers in primary graft~     dysfunction has been less thoroughly explored. We will try in this study de determine the~     rule of pneumoproteins in the donor organ on the pulmonary edema in the recipient.~   "
117307|NCT02032056|"~     The aim of the intervention is to examine the effect of the bacterial strain BB-12, provided~     for 6 mo, on the prevalence of infections and allergic manifestations in small children, and~     how BB-12 affects the immune system, the gastrointestinal tract and the microbiota. Children~     are enrolled during 2 winter seasons.~   "
117308|NCT02032043|"~     Approximately 4,000 people will participate per year. The study population will include~     females and males over 5 years of age who live in filariasis and onchocerciasis endemic~     areas. Subject selection will not be based on health status.~      Two sites will be studied, and each study will last for 4 years. Participants will be studied~     only once in cross-sectional surveys. Some subjects may be included in more than one annual~     population survey, but this is not a longitudinal study.~      Investigators will compare annual and semiannual mass drug administration (MDA) for lymphatic~     filariasis and onchocerciasis, and investigators will compare the impact of these MDA~     schedules on soil transmitted helminth infections. MDA will be administered by others~     (Ivorian Ministry of Health).~      The investigators will test the hypothesis that semiannual mass drug administration (MDA) is~     superior to annual MDA for elimination of lymphatic filariasis, onchocerciasis and for~     control of soil transmitted helminth (STH) infections.~        1. Compare the relative impact and cost effectiveness of annual vs. twice yearly mass drug~          administration (MDA) for elimination of lymphatic filariasis (LF) in these populations.~        2. Compare the relative impact and cost effectiveness of annual vs. twice yearly mass drug~          administration (MDA) for elimination of onchocerciasis in these populations.~        3. Study the impact of annual vs. semiannual MDA on soil transmitted helminth (STH)~          infection in these populations.~   "
117309|NCT02032030|"~     Based on limited published epidemiological data, up to an alarming 1 in 50 surgical~     inpatients die within 30 postoperative days. Based on our own data from the B-Unaware~     (NCT00281489) and BAG-RECALL (NCT00682825) clinical trials, 30-day postoperative mortality~     among high-risk surgical patients is comparable to this at Barnes-Jewish Hospital, and 1-year~     mortality among high-risk surgical patients may be as high as 10%. Short- and~     intermediate-term postoperative mortality is therefore a pressing public health concern.~     Similarly, postoperative major morbidity - including delirium, stroke, myocardial infarction,~     atrial fibrillation, blood clots, renal dysfunction, wound infection, pneumonia, respiratory~     failure, loss of functionality, and chronic pain - occurs commonly and affects a substantial~     proportion of surgical patients, critically ill patients and patients undergoing procedures~     for chronic pain. Many factors associate strongly and independently with postoperative~     mortality and major morbidity: patient age, functional status, comorbid medical conditions,~     and duration and invasiveness of surgery, among others. It is a strategic priority to~     identify pre- and intraoperative risk factors that are subject to modification.~   "
117310|NCT02032017|"~     The purpose of this study is to investigate whether revalidation following total hip~     replacement through the percutaneous approach is faster or better than following the~     anterolateral approach. We assume this would be the case since it is possible to spare a~     large part of the gluteus medius muscle with the percutaneous approach.~   "
117311|NCT02032004|"~     The primary objective of this study is to determine whether transendocardial delivery of~     allogeneic human bone marrow-derived MPCs (rexlemestrocel-L) is effective in the treatment of~     chronic heart failure due to LV systolic dysfunction.~   "
117312|NCT02031991|"~     This study is to prove that the handling (also referred to as pharmacokinetics) of the~     following drugs PF-06439535, Avastin® (bevacizumab) that is licensed for use in the United~     States (bevacizumab-US) and Avastin® (bevacizumab) obtained from Europe (bevacizumab-EU) is~     similar in healthy male volunteers after receiving a single intravenous dose of either drugs.~      During the course of the study, the similarity in pharmacokinetics will be assessed by~     sampling the levels of drug in the blood, and by comparing these levels among the different~     administration arms of PF-06439535, bevacizumab-US and bevacizumab-EU. Safety, tolerability,~     and immunologic response to the administered drugs will also be evaluated throughout.~   "
117338|NCT02031653|"~     To provide evidence of promising tests to noninvasively diagnose bladder outlet obstruction~     (BOO) in men with benign prostatic hyperplasia.~        1. Penile cuff test provides a means of obtaining a urodynamic diagnosis with a high level~          of accuracy without the morbidity and expense of invasive Pressure flow study.~        2. Penile cuff test may be particularly useful in the counseling of patients prior to~          benign prostatic hyperplasia operation. Patients diagnosed as obstructed following a~          penile cuff test can be reassured that surgery has a high chance of resulting in~          symptomatic benefit~   "
117315|NCT02031952|"~     The preventive lymphadenectomy is not performed routinely for hepatocellular carcinoma (HCC)~     patients in clinical practice. While many patients suffered the recurrence without the~     evidence of portal or hepatic vascular invasion or multiple loci, it lead to reconsider the~     value of preventive resection of regional lymph node for those patients. Recently, more and~     more studies had found the incidence of lymph node metastasis was higher in autopsy specimen~     than those in operable patients.~      This project is a prospective randomized controlled trial, planning to compare hepatectomy~     with hepatectomy combined lymphadenectomy regarding of the safety and efficacy in HCC~     patients, to reach a further understanding of the role of lymphadenectomy.~   "
117316|NCT02031939|"~     Although neoadjuvant chemoradiotherapy has significantly reduced the risk of local recurrence~     in locally advanced rectal cancer, systemic failure remains a predominant issue probably due~     to the insufficient control of systemic micro-metastasis in the neoadjuvant treatment.~     Induction chemotherapy is one of the most studied strategies. However, the efficacy of~     induction chemotherapy prior to neoadjuvant chemotherapy remains controversial. In our~     previous study, induction chemotherapy, gap chemotherapy combined with neoadjuvant~     chemoradiotherapy can improve response rate of rectal cancer patients, but the results have~     not been confirmed in clinical trial. Whether this new kind of treatment can optimize~     neoadjuvant therapy for locally advanced rectal cancer or not is still a big problem in~     clinical practice. This study will focus on how to optimize neoadjuvant chemotherapy.~   "
117317|NCT02031926|"~     Healthy subjects will be trained to used correctly a positive expiratory pressure device. The~     aim of the study is to evaluate te reproductibility of the correct used of the device after~     training~   "
117318|NCT02031913|"~     Hepatic steatosis and insulin resistance are associated with severity of fibrosis in~     non-alcoholic fatty liver disease (NAFLD) and chronic hepatitis C. However, clinical~     significance of steatosis and insulin resistance on fibrosis in chronic hepatitis B (CHB) is~     not well established. The aim was to investigate the relationship between insulin resistance,~     hepatic steatosis, and fibrosis in patients with CHB.~   "
117319|NCT02031900|"~     This is a single center, single arm, open label observational trial of patients undergoing~     EGD. The primary objective of this clinical trial is to evaluate the ability of physicians to~     position the NvisionVLE Optical Probe to acquire an image of an area of the esophagus to~     identify and discriminate abnormal areas of tissue from normal.~   "
117320|NCT02031887|"~     The primary objectives of this trial are:~        -  to show differences in the colonization of the gastrointestinal tract with the bacteria~          Bifidobacterium sp. between infants born by normal or caesarean delivery, fed with the~          test or a control product~        -  to investigate whether there is equivalence in growth between the four different groups~          of infant described above.~   "
117321|NCT02031874|"~     Immunosuppressed patients are at increased risk for complications of influenza infection,~     including secondary pneumonia and are recommended for annual influenza vaccination. Thus, the~     appearance of a novel subtype of influenza A virus designated as 2009 swine H1N1 virus has~     added an extra layer of complexity in the immunization regimen in this population. In~     general, susceptibility to swine H1N1 infection among young population is higher as young~     adults and children completely lack protective titers. According to the Center for Disease~     Control (CDC), 70 percent of people hospitalized with H1N1 have been high risk cases,~     including persons 65 years of age or older, or people with compromised immune systems as~     observed during HIV infection. This has prompted CDC to include HIV infected children to be~     one of the five groups to be vaccinated with the new H1N1 vaccine (National Center for~     Immunization). Currently no information exists about the nature of the immune response to the~     vaccine against H1N1 swine-origin influenza virus (S-OIV) in HIV infected children. It is~     unknown whether HIV impairs the immunogenicity of the vaccine predisposing this population to~     infection with S-OIV. Thus, a pilot proposal is being undertaken to study the mechanism of~     H1N1 vaccine protection in HIV infected children, by investigating the correlation of~     infection status with seroresponse, duration of response and development of influenza-like~     illness following vaccine. Additionally we will establish whether we can identify immune~     signatures by characteristic gene expression patterns correlating with the vaccine~     immunogenicity that can be predictive of efficacy for good and suboptimal vaccination~     regimen. Data generated will be used to initiate a comprehensive study on the immunogenicity~     of the influenza vaccines in HIV-infected children and youth, which is critically important~     to address the health care needs of this vulnerable population.~   "
117322|NCT02031861|"~     The purpose of this study is to compare nifedipine controlled-release (CR) tablets (Xin Ran)~     with nifedipine controlled-release tablets (Adalat）in the treatment of mild to moderate~     essential hypertension.~   "
117323|NCT02031848|"~     By doing this study, researchers hope to learn whether a person's motivation for food is~     different after he or she loses weight, and if imaging techniques such as fMRI can be used to~     predict whether the person will maintain that weight loss over time.~   "
117324|NCT02031835|"~     The purpose of this current prospective study is to assess the effects of body weight support~     treadmill training (BWSTT) in individuals with spinal cord injury (SCI). Training~     intervention aim at improving: quality of life, walking capability, spasticity, functions in~     every day life, bone mass density and related hematological factors. The examination~     consisted of (1) neurological classification by ASIA standard neurological classification of~     spinal cord injury working sheet, (2) spasticity evaluation of lower limbs by Modified~     Ashworth Scale, (3) walking independence evaluation by Walking Index for Spinal Cord Injury~     II (WISCI II), (4) patient's quality of life perspective by World Health Quality of Life-~     BREF (WHOQOL-BREF), (5) the functional status by 10-item Modified Barthel Index, (6) bone~     mass density (BMD) by Dual-energy X-ray absorptiometry (DXA) scan, (7) body tissue~     consistency by full body DXA scan, (8) skeletal system health associated blood factors~     (calcitonin, osteocalcin, 25 OH vitamin D, 1,25- (OH)2 vitamin D, ostase and parathyroid~     hormone) by hematological tests. The results will be collected and evaluated using~     statistical software (i.e. SPSS).~   "
117325|NCT02031822|"~     Headache is one of the most common reasons for patients to access healthcare. Greater~     occipital nerve (GON) block with local anesthetic and steroid has been described for the~     management of primary headache refractory to conventional treatment. Two ultrasound~     (US)-guided techniques for greater occipital nerve (GON) block have been described for the~     management of refractory headache syndromes: a proximal technique performed at the level of~     the second cervical vertebra and a distal technique performed at the level of the superior~     nuchal line. Our airm is to compare the accuracy, efficacy and safety of these two techniques~     in patients with refractory headaches.~   "
117326|NCT02031809|"~     This study investigates the most common major complications that result in unplanned~     additional surgery in patients undergoing vats anatomical resections. Several high-volume~     European centres participate. The purpose is to quantify these major complications, discuss~     the steps that can be taken to prevent these events, how they can be dealt with, be it by~     vats or conversion~   "
117327|NCT02031796|"~     The purpose of this work is to evaluate the feasibility of a new Cardiac Vascular~     Reconstruction (CAVAREC, Siemens Medical Systems, Germany) image reconstruction algorithm for~     use during transcatheter aortic valve implant (TAVI) procedures. CAVAREC utilizes the same~     x-ray projection images as currently acquired for clinical DynaCT. X-ray image acquisition to~     allow CAVAREC will occur during the TAVI procedure and after the TAVI device is implanted. If~     you already have a surgically-implanted TAVI device and are having a cardiac catheterization,~     then an extra set of images will be acquired after your clinical care is complete, but before~     you leave the procedure room. The CAVAREC image processing algorithm will be implemented on~     an off-line workstation after the TAVI procedure is complete. After the TAVI procedure,~     CAVAREC images will be quantitatively and qualitatively compared to Siemens DynaCT and~     cardiac CT images from Radiology. The results of this study will be used to direct further~     development of CAVAREC toward the end goal of providing improved imaging capabilities to~     guide TAVI procedures.~   "
117328|NCT02031783|"~     The primary objective is to show that multiple transportable carbohydrate ingestion is more~     effective in improving endurance performance compared to single transportable carbohydrate~     ingestion.~   "
117329|NCT02031770|"~     Cardiovascular disease (CVD) is the leading cause of death in patients with chronic kidney~     disease (CKD) and large artery damage is a major factor that contributes to death. Metabolic~     acidosis is a common complication of CKD resulting from an inability of the diseased kidney~     to excrete the daily dietary acid load and it is associated with all-cause mortality in~     patients with CKD. However, the effect of treatment of metabolic acidosis with oral sodium~     bicarbonate on endothelial dysfunction and arterial stiffness in patients with CKD has not~     been evaluated. The investigators propose a prospective, randomized, controlled, open-label~     14-week crossover pilot study examining the effect of treatment of metabolic acidosis with~     oral sodium bicarbonate on vascular endothelial function in 20 patients with CKD stage IV~     with metabolic acidosis.~   "
117330|NCT02031757|"~     Gait dysfunction often occurs following stroke, neurological or musculoskeletal disease,~     injury and surgery. One of the consequences of such deficit is an increased risk of fall and~     injury. A gait training regime that incorporates controlled perturbation has been found to~     reduce falls in elderly population but the effectiveness of such training has yet to be~     studied.~      The aim of this study is to evaluate the effectiveness of specific controlled dynamic~     perturbation training, during gait, on gait rehabilitation, fear of falling and falling with~     gait impaired individuals. Perturbation will be performed using a specifically designed~     system that provides small, controlled and unpredictable perturbations during treadmill~     walking.~   "
117331|NCT02031744|"~     This randomized, Phase III, double-blind, placebo-controlled study will evaluate the safety~     and efficacy of MetMAb (onartuzumab) in combination with Tarceva (erlotinib) compared with~     treatment with Tarceva alone in patients with incurable Met-positive non-small cell lung~     cancer (NSCLC). Patients will be randomized in a 2:1 ratio to receive either MetMAb + Tarceva~     or placebo + Tarceva. Tarceva (150 mg) will be given orally once daily, and MetMAb (15 mg/kg)~     will be given intravenously every 3 weeks. Treatment will continue until disease progression,~     unacceptable toxicity, a decision to discontinue, or death occurs. Total study length is~     expected to be around 36 months.~   "
117332|NCT02031731|"~     This phase I study will examine the pharmacokinetics and safety of Onartuzumab (MetMAb) in~     chinese patients with locally advanced or metastatic solid tumors. Patients will be divided~     into 3 cohorts, which will each be given a different dose of MetMAb. The cohorts will be~     treated sequentially, starting with the lowest dose. MetMAb will be administered~     intravenously every 3 weeks. Patients may be treated for up to 16 cycles (21 days each) or 1~     year, whichever occurs first, in the absence of disease progression.~   "
117333|NCT02031718|"~     This study will develop and evaluate the efficacy of an Internet-based education program~     incorporating virtual coaching. For this study, the virtual coach will consist of online~     videos aimed at providing acne education and promoting behaviors that support healthy skin.~     The use of Web-based technologies and virtual coaching in acne-related patient education is~     novel, and may significantly improve clinical outcomes and quality of life in acne patients.~     We hypothesize that an interactive Internet-based education and counseling program will be~     more effective than Internet-based education alone in improving clinical outcomes and quality~     of life in acne patients.~   "
117334|NCT02031705|"~     It has been demonstrated that successful cavotricuspid isthmus ablation may be effective in~     preventing paroxysmal atrial fibrillation. However, the effectiveness of only isthmus~     ablation on atrial fibrillation itself is unclear.~   "
117335|NCT02031692|"~     The purpose of this study is to determine whether the supplementation of vitamin D and~     calcium prevents recurrences of benign paroxysmal positional vertigo in patients with vitamin~     D deficiency/insufficiency.~   "
117336|NCT02031679|"~     The investigators are recruiting for a chronic hives study. This research is being done to~     test whether an investigational drug called AstraZeneca drug (AZD)1981 may be helpful for~     treating people with Chronic Idiopathic Urticaria who continue to have symptoms despite~     taking antihistamines. The word investigational means that AZD1981 is not approved for~     marketing by the Food and Drug Administration (FDA). The FDA is allowing the use of AZD1981~     in this study.~      People with chronic hives lasting for at least 6 months and without a known cause may join.~     The study involves 6 visits over 8 weeks. Approximately 48 participants expected to take part~     in this study at the Johns Hopkins Asthma and Allergy Clinic. All participants will be~     treated with the study medication and/or placebo for 8 weeks.~      The results of this trial may have a benefit others with Chronic Idiopathic Urticaria who~     don't respond well to antihistamines by generating experience and data to support the design~     of a larger, multicenter trial investigating the efficacy of AZD1981 in treating~     antihistamine refractory CIU.~   "
117337|NCT02031666|"~     The purpose of this study is to evaluate the pharmacokinetics (what the body does to the~     medication) and relative bioavailability (the extent to which a medication or other substance~     becomes available to the body) of JNJ-56021927 when administered as 7 test tablet~     formulations of JNJ-56021927 compared with the softgel capsule formulation of JNJ-56021927 in~     healthy male participants under fasted conditions at a single dose of 240 mg.~   "
117339|NCT02031640|"~     This is a Phase 3, randomized, placebo-controlled, double-blind,double-dummy, parallel-group,~     12-week study in male and female patients, 12 years of age and older, with persistent asthma.~   "
117341|NCT02031614|"~     Although phlebotomy is routinely performed in blood donors, and seemingly does not have~     significant health risks, it is highly relevant to know what the effect of phlebotomy is on~     immunity. Alterations in immunity due to phlebotomy could have beneficial effects, like the~     suppression of the low grade inflammatory process that contributes to atherosclerosis, but in~     theory could also contribute to a suppressed innate immune response that could increase the~     risk of infection. This is not only relevant for blood donors, but also for patients~     suffering from blood loss and for daily clinical practice in which blood is routinely drawn~     of patients for laboratory determinations.~   "
117342|NCT02031601|"~     Objective: To compare the efficacy and safety of chemotherapy plus intercalated EGFR-tyrosine~     kinase inhibitors (TKI) combination therapy with TKI alone therapy as first-line treatment~     for patients with non-small-cell lung cancer (NSCLC).~      Methods: Patients with untreated, stage IIIB/IV, EGFR mutation-positive NSCLC will be~     randomly assigned to combination therapy group (receiving four cycles of docetaxel or~     pemetrexed (on day 1) plus platinum (on day 1) with intercalated TKI (gefitinib, erlotinib or~     Icotinib, on day 2-15) every 3 weeks) or TKI alone therapy (gefitinib, erlotinib or Icotinib,~     daily). All patients were continued to receive TKI until progression or unacceptable to~     toxicity or death. The primary endpoint was progression-free survivial (PFS).~      Expected results: PFS of combination therapy group will be prolonged to nineteen months while~     PFS of TKI alone therapy group is ten months. Overall survival (OS) of combination therapy~     group will be prolonged to 36 months while OS of TKI alone therapy group is 26 months.~      Hypothesis: Platinum-based chemotherapy plus intercalated TKI combination therapy as~     first-line treatment will prolong PFS and OS for patients with NSCLC.~   "
117343|NCT02031588|"~     Observational study of the effects of antibiotics on commensal flora. Realization of stool~     samples and nasal swabs before and after antibiotic therapy.~   "
117344|NCT02031575|"~     The purpose of the Study on Mhealth and Reproductive Health in Teens (SMART) is to evaluate~     the effectiveness of using text messages to improve the knowledge, communication, and~     attitudes about reproductive health among female adolescents in Greater Accra senior high~     schools. Previous research as well as qualitative work conducted by the Investigators shows~     that there are significant gaps in knowledge about reproductive health including on topics of~     pregnancy, sexually transmitted diseases, and contraception among secondary school students~     in Greater Accra. These gaps contribute to unwanted pregnancy and spread of sexually~     transmitted diseases. At the same time, phone ownership and use among young people has spread~     rapidly, especially in urban areas such as Accra. The Study on Mhealth and Reproductive~     Health (SMART) will seek to use mobile phone messages to increase awareness of these~     reproductive health issues among female adolescents in Accra. The objectives of SMART are to~     evaluate whether the messages can increase knowledge, increase communication, and improve~     attitudes towards reproductive health among adolescents in Greater Accra. By conducting a~     randomized controlled trial, we will be able to statistically evaluate if the messages have~     had any effect on improving outcomes for adolescents in the areas of knowledge,~     communication, and attitudes. This work can help guide future programs that can scale up this~     intervention and ultimately improve the health and wellbeing of adolescents across Ghana.~   "
117345|NCT02031562|"~     This study evaluates the effect of standard of care treatments (physical therapy versus~     manual therapy) in older adult patients who have balance problems with or without low back~     pain.~   "
117346|NCT02031549|"~     We will investigate potential correlation between SpermComet DNA fragmentation assay results~     and IVF cycle outcome.~   "
117347|NCT02031536|"~     This randomized phase II trial studies how well everolimus works in treating patients with~     pancreatic neuroendocrine tumors metastatic to the liver previously treated with surgery.~     Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Giving everolimus after surgery may kill any tumors cells that remain.~   "
117348|NCT02031523|"~     It is a multi-center, double -blind, placebo -controlled, randomized post-marketing study in~     Chinese subjects with endometriosis-associated pain to assess treatment effect and safety in~     the subjects treated with Sanjie Analgesic Capsule versus subjects treated with placebo.~   "
117349|NCT02031510|"~     The use of dexmedetomidine as an adjunct to bupivacaine in transversus abdominis plane block~     will reduce the cumulative morphine consumption after laparoscopic cholecystectomy.~   "
117350|NCT02031497|"~     The purpose of this study is to determine whether consumption of carbonated drinks containing~     sweeteners affect insulin sensitivity.~   "
117351|NCT02031484|"~     This study is intended to compare the new Carnation patch monitoring system with the Zio~     patch, which represents the current standard for continuous recording of the ECG over~     extended periods.~   "
117352|NCT02031471|"~     This open-label, single-arm study will evaluate the efficacy, safety and tolerability of~     subcutaneously administered tocilizumab in monotherapy and/or in combination with~     methotrexate and other non-biologic disease modifying anti-rheumatic drug (DMARDs) in~     participants with active rheumatoid arthritis (RA) who are naïve to tocilizumab. Participants~     will receive tocilizumab 162 milligram (mg) subcutaneously weekly for 24 weeks. Participants~     who complete the core study achieving at least a moderate European League Against Rheumatism~     (EULAR) response at Week 24 may enter the extension phase and receive for a further 28 weeks~     at the most.~   "
117353|NCT02031458|"~     This multicenter, single-arm study will evaluate the efficacy and safety of Atezolizumab in~     participants with PD-L1-positive locally advanced or metastatic non-small cell lung cancer~     (NSCLC). Participants will receive Atezolizumab 1200 milligrams (mg) intravenously every 3~     weeks as long as participants are experiencing clinical benefit as assessed by the~     investigator, that is , in the absence of unacceptable toxicity or symptomatic deterioration~     attributed to disease progression.~   "
117354|NCT02031445|"~     Randomized, double-blind, parallel group, placebo-controlled, multicenter, efficacy and~     safety study in subjects with mild to moderate atopic dermatitis.~      Following the double blind period, subjects will be allowed to continue treatment with~     topical MRX-6 Cream 2% in an open-label extension. Demonstrate the efficacy of MRX-6 Cream 2%~     compared to Vehicle for the treatment of the signs and symptoms of atopic dermatitis and~     demonstrate the safety of MRX-6 Cream 2% for the treatment of the signs and symptoms of~     atopic dermatitis.~   "
117357|NCT02031406|"~     A significant portion of avoidable healthcare expenditures has been attributed to preventable~     hospital readmissions; thus, reducing hospital readmission rates has become a national~     healthcare agenda item. Despite much study of this topic, efforts to date have not been~     especially fruitful in either predicting which patients will require hospital readmission.~     Preventing readmissions has been even more difficult.~      We recently examined a pharmacist intervention that assessed patients' medication literacy~     and adherence at hospital admission. In this retrospective data, low medication adherence~     levels were predictive of hospital readmission. There was a non-significant trend between low~     medication literacy and increased hospital readmissions.~      We have now decided to prospectively study this intervention. Prospective study will allow~     for several improvements on our prior work.~        1. We have consulted the literature to more carefully examine existing instruments to~          measure medication adherence and literacy. Based on this review, and based on our prior~          results, we have made adjustments to these instruments which should improve reliability,~          validity, and granularity.~        2. In our retrospective work, our intervention of pharmacist counseling was not randomized.~          Although there were large differences in readmission rates between the patients selected~          to receive counseling and those who were not thought to require it, there may have been~          unmeasured confounding variables. Randomizing this intervention will greatly enhance the~          likelihood that we are comparing two similar groups of patients.~   "
117358|NCT02031393|"~     The purpose of this study is to determine whether we can establish different markers suc as~     mean arterial pressure , flow in the uterine arteries, biochemical markers in maternal blood~     and more un the first trimester, in order to screen for twin pregnancies that are more likely~     to develop adverse pregnancy outcome: early delivery, pre eclampsia or small fetuses.~   "
117359|NCT02031380|"~     The purpose of this study is to evaluate the usability of a medication management support~     system for glaucoma patients self-administering eye drops named iDropper. The iDropper system~     is a home-based ocular medication management system that reminds, instructs, dispenses, and~     records eye drop medication usage. The iDropper system will be evaluated among a cohort of~     glaucoma subjects self-administering eye drops for 4-weeks.~   "
117360|NCT02031367|"~     The object of this study is to compare the effect of PRP versus Corticosteroid injection on~     pain in patients with Greater Trochanteric Pain Syndrome up to 12 months after treatment. It~     is believed that PRP will be as good as corticosteroids for short term pain relief, and will~     produce longer lasting pain reduction.~   "
117361|NCT02031354|"~     The purpose of this study is to determine if administration of supplemental chloride in the~     form of lysine chloride to patients with congestive heart failure will affect their~     neurohormonal profile as well as response to diuretics.~   "
117362|NCT02031341|"~     Impaired uptake of glucose by skeletal muscle is a key feature of type 2 diabetes mellitus.~     It is unclear to what extent impaired insulin uptake from capillaries into skeletal muscle~     interstitium plays a role in this process.~      We hypothesize that impaired uptake of insulin from capillaries into skeletal muscle~     interstitium is involved in impaired glucose uptake by skeletal muscle in type 2 diabetes~     mellitus.~   "
117363|NCT02031328|"~     You have been asked to consider participating in the study because you have a cancer of the~     prostate, which is to be treated with external beam radiation. You have chosen or felt not to~     be a good candidate for just watching your cancer. As your doctor has informed you, this~     involves delivering small amounts of radiation daily over several weeks. Normally, a small~     field directed to the prostate gland is given for 7.5 - 8 weeks. In total, 39 days of~     radiation are delivered. There is now growing evidence that prostate cancer cells may be~     killed more effectively if higher doses of radiation are delivered everyday (known as~     hypofractionation). However, the downside to such a strategy is the potential to cause more~     side effects because normal organs (such as the rectum and bladder) are also exposed to the~     higher doses. Stereotactic ablative radiotherapy (SABR) is a high-precision technique which~     has the ability to deliver radiation in a more focused manor, meaning that the radiation dose~     can be sculpted to the prostate gland, while minimizing the amount of radiation to the~     bladder and rectum.~      A certain amount of movement of the prostate normally occurs within the body. To make sure~     that the prostate will not be missed, a margin of tissue around the prostate also needs to be~     treated. Although a wide margin will ensure that the prostate is included, it will also cause~     more normal tissue to receive high doses of radiation. This, in turn, would result in more~     side effects. To reduce the margin needed around the prostate, and side effects, tiny gold~     seeds measuring 3.0 x 1.2mm will be inserted into the prostate which can be seen using a~     special type of X-Ray camera called a portal imager during treatment. This will allow for~     targeting of the prostate gland more precisely so that a significantly smaller margin of~     normal tissue will need to be treated. By using gold seeds in conjunction with SABR, there is~     the potential to safely deliver a more intensive dose of radiation to the prostate gland~     without increasing the amount of side effects.~      In other studies where shorter and more intense courses of radiation have been given using~     similar high-precision techniques, the side effects of treatment have indeed been no worse~     than the usual techniques. Over the last 7 years, Sunnybrook researchers have treated over~     three hundred prostate cancer patients on various research protocols with SABR. In those~     protocols, patients received 5 SBRT treatments over 29 days and this is currently being~     compared to 5 SBRT treatments over 11 days in an ongoing randomized study. In the United~     States, several groups have investigated the 5 SBRT approach in 11 days or less and early~     findings suggest a good tolerance.~      The study is being done to determine the side effects, quality of life and efficacy of~     2-fraction adaptive SBRT technique (2STAR) in the treatment of low and intermediate risk~     prostate cancer. All participants will receive the same dose and fractionation scheme.~   "
117364|NCT02031315|"~     Background The burden of sudden death (SD) in sub-Saharan Africa is unknown. The aim is to~     assess the incidence, etiology and patient characteristics of SD in a sub-Saharan country.~     Methods The Douala-SD study is a prospective, multicenter, community-based registry~     monitoring all cases of SD occurring in index areas of Douala city. Investigators will use~     the definition of SD as natural death occurring within 24h at the onset of symptoms.~     Demographic, clinical, electrocardiographic and biological variables (when available) of~     victims will be recorded. All deaths occurring in residents of health areas of interest will~     be checked for past medical history, circumstances of death, and autopsy (if possible).~     Conclusion This maiden Douala-SD study will provide comprehensive, contemporary data on the~     epidemiology of SD in a sub-Saharan African country and will help in the development of~     strategies to prevent and manage SD in Africa.~   "
117365|NCT02031302|"~     The purpose of the RESPOND post market study is to collect real world clinical and device~     performance outcomes data with the Lotus Valve System used in routine clinical practice to~     demonstrate that the commercially available Lotus Valve System is a safe and effective~     treatment for patients with severe calcific aortic stenosis.~   "
117366|NCT02031289|"~     We are performing the above prospective randomized trial in 1'000 patients undergoing cardiac~     surgery. The study will answer the question of whether preoperative treatment of anemia or~     iron deficiency indeed improves transfusion needs (primary outcome) and important clinical~     outcomes (secondary outcome) in a large group of cardiac surgical patients. The list of~     inclusion and exclusion criteria was deliberately chosen short so that this patient group~     largely reflects today's clinical practice .~        -  Trial with medical product~   "
117368|NCT02031263|"~     The investigators will find out if bronchial thermoplasty shows efficacy in reducing acute~     exacerbation and improving quality of life for uncontrolled asthma in Korea through this~     research. US FDA approved this procedure and CE mark was taken in Europe. Many procedure was~     performed in Western countries.~      Korean FDA have approved this procedure in 2013. However, no procedure was performed in~     Korea, and the data is rare in Asian countries. In this study, investigators will examine the~     efficacy of this procedure in Korean asthmatics.~   "
117369|NCT02031250|"~     This study aims to improve locoregional control of poor prognosis Head and Neck Cancer (HNC)~     patients by selectively escalating the radiotherapy dose to subvolumes of tumor likely to be~     resistant to standard Radiation Therapy (RT) using DCE-MRI (Dynamic Contrast Enhanced~     Magnetic Resonance Imaging). Standard doses of radiotherapy to the rest of the tissues and~     surrounding normal tissues will be maintained.~   "
117370|NCT02031237|"~     This study aims to assess changes in vascular permeability in the brain tumor, and in the~     surrounding brain, due to radiation therapy, using Magnetic Resonance Imaging (MRI).~   "
117371|NCT02031224|"~     This is a prospective single center randomized controlled trial with a total duration of 18~     months aiming to evaluate the effectiveness and the safety of a very low protein diet~     supplemented with ketoanalogues of essential aminoacids in reducing the progression of~     chronic kidney disease (CKD) in patients with advanced CKD.~   "
117372|NCT02031211|"~     Studying the effects of Etanercept (an anti-Tumor Necrosis Factor alpha) on early Chronic~     Regional Pain Syndrome (CRPS). Our hypothesis is that Etanercept will improve patient~     symptoms if given in early CRPS.~   "
117373|NCT02031198|"~     This follow-up study continues to observe patients who have completed the phase 1 trial of~     AADvac1, for another 18 months.~      Long-term safety and behavior of the immune response to AADvac1 over time are the main points~     of interest.~      AADvac1 is a vaccine directed against pathologically modified Alzheimer tau protein that is~     the main constituent of neurofibrillary tangles (NFTs), and is intended to be a~     disease-modifying treatment for Alzheimer's disease, i.e. to halt its progress.~      As this study is a Phase I study focused on tolerability and safety, efficacy will be~     assessed in an exploratory manner.~   "
117374|NCT02031185|"~     Due to disparities in childhood obesity, interventions for physical activity promotion and~     obesity prevention for low socioeconomic and racial/ethnic minority children and adolescents~     are vital to address disparities across the lifespan. Mobile health applications (mHealth~     apps) are a rapidly growing and promising approach for interactive and individualized~     interventions for disease prevention. Smart phones are a promising platform to reach~     racial/ethnic minority and lower income groups due to high rates of adoption of smart phone~     usage among these groups When paired with wearable sensing devices, mHealth apps for smart~     phones can collect data and provide feedback to users in real time. In a study among~     university students regarding mHealth apps, participants expressed interest in the ability~     to record and track behaviors and goals and the ability to acquire advice and information 'on~     the go'. For physical activity in particular, wearable physical activity monitors designed~     for consumers that objectively measure and display data related to an individual's physical~     activity on smart phones through mHealth apps have become widely available and affordable.~     These wearable devices wirelessly upload data and provide users with physical activity data~     visualization and goal setting features that can be customized for each user via~     internet-based applications for smart phones, tablets, and/or computers. While several~     internet-based behavioral programs to promote pediatric physical activity have been reported~     in a recent review, none examined wearable sensing devices coupled with mHealth apps.~     Similarly, a 2013 review on mHealth technologies for physical activity assessment and~     promotion reported no studies that used wearable sensing devices for intervention delivery~     and called for research to evaluate feasibility.~      The Primary Goal is to conduct a pilot randomized controlled trial (RCT) of the FitBit Flex,~     a popular wearable physical activity sensing device that allows data visualization and goal~     setting on smart phones. The target population will be adolescents ages 14-18 years old in~     the Seattle-metro area (n=40) with approximately 50% from low income households or belonging~     to a racial/ethnic minority. We will target this older age group since they have the lowest~     levels of physical activity among the pediatric population. This pilot study will provide~     feasibility and preliminary data for a future R01-funded RCT of the Flex mHealth device and~     app.~   "
117375|NCT02031172|"~     This research is being done to to see if changes in visual reading function correlate with~     changes in optical and retinal image quality. We hypothesize that changes and deterioration~     in tear film quality and dynamics may have a negative effect on reading function.~      People with or without dry eye syndrome may enroll.~   "
117376|NCT02031159|"~     Hypothermia is common in patients undergoing general anesthesia. There have been several~     negative outcomes reported. Zero heat flux is a non-invasive method for measurement of body~     core temperature. The aim of this study is to see if this method is comparable in terms of~     correlation, accuracy, precision and practicability to commonly used sublingual and~     nasopharyngeal temperature monitoring.~   "
117377|NCT02031146|"~     Treponema pallidum, the bacterium that causes syphilis, invades the central nervous system in~     about 40% of patients with syphilis. This happens early after infection. Patients with~     neuroinvasion are at risk of developing serious neurological complications, including vision~     or hearing loss, stroke and dementia. Because neuroinvasion can happen without symptoms, the~     only way to identify it is by performing a lumbar puncture (LP) to examine cerebrospinal~     fluid (CSF).The overall hypothesis to be tested in this study is that a strategy of immediate~     LP, followed by therapy based on CSF evaluation, results in better serological and functional~     outcomes in patients with syphilis who are at high risk for neuroinvasion.~   "
117378|NCT02031120|"~     The aim of this study is (1) to assess the incidence of suspected drug allergies in a~     pediatric hospital and the proportion in which these reactions are confirmed to be allergic;~     (2) to evaluate the diagnostic values of the different allergy tests available; (3) to~     investigate the pathophysiology of drug allergies, particularly by investigating the role of~     viruses, and by performing HLA typing and a gene expression profile both in the acute phase~     of the reaction and 2 months later.~   "
117398|NCT02030860|"~     This study is a randomized pilot/pharmacodynamic/genomic study of neoadjuvant paricalcitol to~     target the microenvironment in resectable pancreatic cancer to determine the effect of~     targeting the vitamin D metabolic program in the tumors of patients treated with one cycle of~     gemcitabine/abraxane with or without paricalcitol prior to surgery for resectable pancreatic~     cancer through an assessment of cellular and imaging markers.~   "
117408|NCT02030730|"~     This study investigates the impact of a Triple P Seminar Series on positive parenting for~     universal prevention of behavioural and emotional difficulties in a general Greek sample of~     parents with children aged 2 to 12. It is predicted that, compared to an attention control~     condition, parents randomised to the Seminar Series will report lower levels of children's~     disruptive and emotional difficulties at post-intervention. At the same time, it is~     postulated that parents will show a decrease in dysfunctional discipline styles, greater~     feelings of self-efficacy as well as lower levels of distress. Lastly, it is hypothesized~     that the effects observed at post-intervention will remain at the 6-month follow-up.~   "
117379|NCT02031107|"~     Background: Stroke is a leading cause of adult disability. Non-invasive brain stimulation can~     induce significant and sustained improvements in functional outcome. However the effect is~     inconsistent and difficult to predict, in particular in the subacute phase after stroke.~     Although several different stimulation techniques are available, it is unknown which is~     suitable for which patient.~      Objectives: This study has three main objectives:~        1. To compare the effects of two techniques of non-invasive brain stimulation (cTBC,~          continuous theta-burst stimulation; tDCS, direct current transcranial stimulation) on~          clinical recovery in patients with subacute stroke.~        2. To assess the effect of these brain stimulation techniques on brain organization with~          non-invasive imaging.~        3. To find clinical and neural predictors of responsiveness to brain stimulation therapy.~      Method: 45 patients with ischemic or hemorrhagic stroke will be randomly assigned to one of 3~     groups: cTBS, tDCS, or sham stimulation. Each group will receive the corresponding~     stimulation therapy 3 times per week for 3 weeks, immediately before intensive physical~     therapy. Before and after the treatment period, standardized assessments of sensorimotor~     function areas are obtained together with electroencephalography and functional magnetic~     resonance recordings. These recordings will be used to analyze and compare the neural effects~     of each treatment modality.~      Clinical Implication: The results of this study might help optimize and individualize~     stimulation treatment for patients with subacute stroke. It may hence facilitate the transfer~     of brain stimulation therapy to routine clinical practice.~   "
117380|NCT02031094|"~     This observational study will measure resting energy expenditure in patients who have~     undergone liver resection and compare methods of measuring resting energy expenditure.~   "
117381|NCT02031081|"~     The incidence of gastroparesis has been increasing among Canadians. Symptoms of discomfort~     include early satiety, stomach pain, nausea and vomiting. In addition, because gastroparesis~     slows digestion, it can lead to malnutrition and make controlling blood sugar even more~     challenging for diabetics. Mild cases of gastroparesis can be helped with dietary and~     lifestyle modifications but treatments for more severe symptoms are limited. There are~     several drugs called pro-kinetics available in Canada though results vary among patients and~     these often cause significant side effects. Recently, a drug called Prucalopride was approved~     for use in Canada to treat constipation. It has pro-kinetic properties and has been shown to~     cause few side effects. The investigators propose to test prucalopride as a treatment for~     gastroparesis by recruiting 30 patients from the Calgary area who have gastroparesis. The~     investigators will test the effects of this treatment by alternating 28 days of active~     treatment with prucalopride with 28 days of treatment with a non active placebo adding a two~     week break in between treatments. The order of the treatment will be randomized and neither~     the patients nor the investigators will know whether they are receiving the active treatment~     or the placebo until the study has been completely finished. The investigators will measure~     the effects using questionnaires that assess patient symptoms such as nausea and pain as well~     as quality of life during two gastric emptying tests and throughout the treatment periods.~     The effectiveness of the active treatment will be evaluated by comparing the extent of the~     change in symptoms before and after treatments and the difference in gastric emptying times~     as compared to the placebo treatment. The investigators will also monitor and track all~     possible side effects that patients experience during the study.~      Study Hypotheses~      In patients with gastroparesis:~        1. Prucalopride 4 mg daily improves meal-related symptoms compared to placebo as defined by~          the change in cumulative meal-related symptoms. (primary endpoint).~        2. Prucalopride 4 mg daily accelerates gastric emptying rate compared to placebo.~          (secondary endpoint).~        3. A correlation exists between the effect of prucalopride on gastric emptying rate and~          symptom improvement.~   "
117382|NCT02031068|"~     To test the safety and feasibility of a new treatment for adolescents who are slow to recover~     from a sport-related concussion, the investigators are conducting a randomised controlled~     trial comparing treatment as usual with an active rehabilitation program that involves~     sub-symptom threshold cardiac exertion, sport-specific coordination activities, and positive~     visualisation techniques.~   "
117383|NCT02031055|"~     The purpose of this study is to evaluate, in patients with advanced solid tumors, the mass~     balance of FTD and TPI after a single dose of TAS-102 with a light tracer dose of [14C]FTD or~     [14C]TPI.~   "
117384|NCT02031042|"~     The purpose of this study is to investigate if sentinel lymph node biopsy is a reliable~     staging tool for breast cancer patients planned for neoadjuvant chemotherapy (=before breast~     surgery) and if, in that case, it is safe to omit axillary lymph node dissection if the~     sentinel lymph node is free of metastasis.~   "
117385|NCT02031029|"~     It has previously been reported that men with prostate cancer are 1 ) reduced quality of life~     after diagnosis and treatment, 2 ) neuroticism increases the reduction in QoL related to~     treatment side effects, and 3) often have very involved and active spouses who seems to have~     been handed over / taken over parts of the men's responsibility for their own health. We~     postulate herein a new hypothesis that the stress level is elevated when harbouring~     undetected prostate cancer. We will investigate whether those who are diagnosed with prostate~     cancer already in beforehand have an increased degree of masculine stress ( experience of not~     living up to their own perception of the ideal man ) and neuroticism in the typology. We will~     examine different personality and QoL questionnaires for patients with elevated PSA, and~     compare those whose clinical assessment later reveals prostate cancer, with three control~     groups: 1) men with elevated PSA who are not diagnosed with prostate cancer, 2) men with~     normal PSA treated for benign prostate enlargement and 3) patient with substantial risk of~     colorectal cancer (CRC) who undergo colonoscopy, with regard to increased level of masculine~     stress and the personality trait neuroticism.~   "
117386|NCT02031016|"~     This study will investigate the influence of intra-operative use of remifentanil versus~     fentanyl on the percentage of patients with chronic thoracic after cardiac surgery via~     sternotomy. Secondary quantitative sensory testing is performed to determine thermal and~     electrical detection and pain threshold and the difference in pain variability scoring.~     Postoperative pain scores, analgesic use, genetic variances and costs are measured.~   "
117387|NCT02031003|"~     -  The primary objective of the study was to compare stool composition (stool soap and~          non-soap fatty acids, total fatty acids, minerals, and other stool constituents) of~          infants randomized to receive either standard formula, or 1 of 2 innovative formulas~          containing a new fat blend or the new fat blend plus fiber.~        -  The secondary objectives were to evaluate among the feeding groups, stool~          characteristics (stool consistency and frequency), GI tolerance assessed by the Infant~          Gastrointestinal Symptom Questionnaire (IGSQ), and urinary markers (F2-isoprostanes and~          8-hydroxy-2'-deoxyguanosine [8-OHdG], and urine osmolality and specific gravity).~        -  The primary safety objective was to describe the frequency of adverse events (AEs) among~          the formula-fed (FF) groups.~        -  The secondary safety objective was to describe anthropometric measures (weight, length,~          and head circumference) among the feeding groups.~   "
117913|NCT02024139|"~     This study investigates whether chewing sugar-free chewing gum can reduce pain associated~     with braces treatment. The study collects pain scale records for 10 consecutive days after~     placement of braces. No changes to patients routine braces treatment is done. All materials~     used are available over the counter.~   "
117388|NCT02030990|"~     1. Purpose To evaluate the use of mitomycin-C (MMC) as an intraoperative adjunct during~          photorefractive keratectomy (PRK), its effect on postoperative healing and its ability~          to reduce the postoperative topical steroid course after the surgery.~        2. Research Design This is a single-center, prospective, comparative cohort study.~        3. Hypothesis There will not be a significant difference in the refractive corrections~          amongst the treatment groups, 12 months after surgery.~        4. Objectives The primary study objective is to compare the effect of intraoperative MMC~          and a postoperative short topical steroid taper of 3 weeks, intraoperative MMC and a~          rapid topical steroid taper of 1 week, and a more commonly accepted postoperative~          regimen of a 2 month long topical steroid taper without any intraoperative MMC. The~          primary endpoint evaluated will be objective estimates of refractive error (WaveScan~          WaveFront™ System) at 12 months post-surgery. Secondarily, the extent of haze formation~          will be evaluated objectively using densitometry maps generated by automated Scheimpflug~          imaging of the cornea (Pentacam®). Furthermore, the subjective vision from the patients'~          perspective will be evaluated by questionnaires.~   "
117389|NCT02030977|"~     To study the effects of Resveratrol supplement on lipid profile, liver enzymes, inflammatory~     factors and hepatic fibrosis in patients with Nonalcoholic Fatty Liver (NAfLD), 50 patients~     who referred to Gastrointestinal (GI) clinic with steatosis grade 1 or more will be randomly~     allocated to receive 1 Resveratrol capsules or placebos for 12 weeks; both groups will be~     advised to adherence our diet and exercise program too. At the first and the end of the~     intervention, lipid profiles, liver enzymes, some inflammatory cytokines, and liver fibrosis~     will be assessed and compared between groups.~   "
117390|NCT02030964|"~     This study will combine an oral drug called DFMO with celecoxib (also oral) and two IV~     chemotherapy medicines called cyclophosphamide and topotecan.~        -  To find the highest dose of DFMO that can be given with celecoxib, cyclophosphamide and~          topotecan without causing severe side effects.~        -  To find out the side effects seen by giving DFMO at different dose levels with~          celecoxib, cyclophosphamide and topotecan.~        -  To measure the levels of DFMO in the blood at different dose levels.~        -  To determine if your tumor gets smaller after treatment with DFMO, celecoxib,~          cyclophosphamide and topotecan.~        -  To determine if specific gene changes in you or your tumor makes you more prone to side~          effects or affects your tumor's response to the combination of DFMO, celecoxib,~          cyclophosphamide and topotecan.~        -  To determine if the amount of normal chemicals in your body called polyamines go down in~          response to DFMO, celecoxib, cyclophosphamide and topotecan, and whether you are more~          likely to have a good response to the treatment if they do.~   "
117391|NCT02030951|"~     Feeding that circumvents the oral cavity drastically alters the infant's feeding experience~     (pre, intra and post feeding) and may lead to oral feeding difficulty. It is estimated that~     35 - 40% of infants exhibit oral feeding difficulty. Consequences include delayed oral~     feeding, growth failure, and inadequate mother-infant interaction. Behaviors related to the~     feeding experience include behavioral state transitions, orally directed behaviors, hunger~     and satiation cues, and social interactive behaviors. It is unknown whether these early~     behaviors differ for hospitalized infants who receive long term tube feedings when compared~     with infants fed orally or whether alterations in these behaviors can be early indicators of~     later oral feeding difficulty. Documentation of these missing or altered behaviors is needed~     prior to the development and testing of interventions to prevent oral feeding difficulty.~      For 75 hospitalized infants with long term tube feedings, this research will: 1) describe the~     range of early feeding behaviors encompassing the feeding experience; 2) identify the change~     in early feeding behaviors throughout hospitalization; 3) compare the early feeding behaviors~     of infants with and without oral feeding difficulty at 12 months corrected age (CA); and 4)~     compare parent perception and provider assessment of feeding, for infants with and without~     oral feeding difficulty.~      We will document infant behaviors surrounding the feeding experience during tube feedings~     weekly during hospital stay. Throughout the first year of life, infant growth, parent~     perception and clinician assessment of infant feeding and infant and maternal behavior during~     feeding will be evaluated to document the occurrence of oral feeding difficulty, allowing for~     a comparison with early in hospital feeding behaviors. To analyze for changes over time, we~     will use Generalized Linear Mixed Models (GLMM) for repeated count (Poisson) and~     frequency/categorical (logistic and multinomial logistic) outcomes (e.g., frequency of infant~     behaviors). Understanding the constellation of these behaviors and when they begin, will~     guide the development of interventions whose goal will be to alleviate the long term~     consequences of oral feeding difficulty, inform clinical practice, and reduce cost.~   "
117392|NCT02030938|"~     An evaluation of the clinical performance of SERI® Surgical Scaffold for soft tissue support~     in subjects undergoing revision augmentation surgery for increased nipple to inframammary~     fold distance.~   "
117393|NCT02030925|"~     This study is meant to assess the effect of IW-3718 as an added treatment to ongoing~     once-daily protocol pump inhibitor (PPI) treatment for patients who continue to experience~     symptoms of their gastroesophageal reflux disease (GERD).~   "
117394|NCT02030912|"~     A randomised, open labelled study design is selected in order to determine the emergence and~     persistence of antibiotic resistant bacteria in humans and on the composition of the~     indigenous microbiotas at various body sites. These will involve the administration to~     volunteers of minocycline and amoxicillin- a control group will receive a placebo.~     Microbiology of the skin, saliva, faecal, skin and nasal micro flora, safety and adverse~     events, vital signs, will be evaluated. The objectives of metagenomic analysis are:~        -  To identify the in vivo molecular mechanisms responsible for antibiotic resistance and~          its transfer in the indigenous oral and faecal microbiotas using metagenomics resistome~          analysis.~        -  To determine the impact of the use of antimicrobial agents on the oral resistome~        -  To determine the impact of the use of antimicrobial agents on the faecal resistome~        -  To determine the ecological impact of the use of antimicrobial agents on the relative~          abundance of phylotypes of the indigenous oral microbiota~        -  To determine the ecological impact of the use of antimicrobial agents on the relative~          abundance of phylotypes of the indigenous faecal microbiotas~   "
117395|NCT02030899|"~     The use of plate in addition to autologous bone is better then stand alone cage fusion~     regarding fusion rate and segmental lordosis.~   "
117396|NCT02030886|"~     The purpose of the study is to assess the relationship between IOP pattern as recorded over~     24 hours by using Triggerfish and quantified by acrophase scored dichotomously, and~     conversion to glaucoma in OHT patients (conversion status). Elevation of IOP above normal~     range is called ocular hypertension (OHT). In a previous study, it has been shown that OHT~     patients who progress to glaucoma (converters) have at baseline and prior to any conversion,~     IOP patterns that more closely resemble those of established early primary open-angle~     glaucoma (POAG) patients, while stable OHT patients (non-converters) have IOP patterns closer~     to those of healthy control subjects. The study has been planned to recruit at least 48~     eligible patients (24 converters and 24 non-converters).~   "
117397|NCT02030873|"~     The purpose of this study is to investigate the effect of virtual simulation training on~     mastoidectomy dissection performance of otorhinolaryngology trainees, to explore performance~     assessment using a final-product analysis approach and to explore the role of cognitive load.~   "
117399|NCT02030847|"~     This is a single center, single arm, open-label phase II study to determine the efficacy and~     safety of a single infusion of autologous T cells expressing CD19 chimeric antigen receptors~     expressing tandem TCR and 4-1BB (TCR/4-1BB) co-stimulatory domains (referred to as CART-19~     cells) in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia.~     Inclusion criteria are designed to include adult patients aged greater than 18 with B cell~     ALL, relapsed or refractory, with no available curative treatment options (such as autologous~     or allogeneic stem cell transplantation) who have limited prognosis (greater than 12 weeks~     survival expectancy) with currently available therapies. The study product is CART-19 cells~     transduced with a lentiviral vector to express anti-CD19 scFv TCR:41BB administered by a~     single i.v. infusion of 1 to 5 x 108 transduced CAR T cells.~   "
117400|NCT02030834|"~     Phase IIa study to estimate the efficacy of a single infusion of autologous T cells~     expressing CD19 chimeric antigen receptors expressing tandem TCR and 4-1BB (TCR /4-1BB)~     costimulatory domains (referred to as CART-19 or CTL019 cells) in non-Hodgkins Lymphoma (NHL)~     patients. The duration of active protocol intervention is approximately 24 months from~     screening visit. The protocol will require approximately 48 months to complete.~   "
117401|NCT02030821|"~     The purpose of this study is to determine the relative effectiveness of two drug agents,~     Tranexamic acid (TXA) and aminocaproic acid (Amicar), that act through a similar mechanism of~     action. These agents are used to decrease blood loss that is a result of major surgery, like~     total joint arthroplasty. A secondary goal will be investigate the cost-analysis of total~     hospitalization. Both TXA and Amicar are both currently used in the care of patients~     undergoing total joint arthroplasty.~      Subjects will be randomly assigned to the TXA or Amicar arm. All data needed for this study~     including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit~     and hemoglobin, and complications will be collected during the hospitalization stay.~      Our Hypothesis is that TXA and Amicar will have similar effectiveness in preventing~     intraoperative blood loss and the need for transfusion post-op than Amicar.~      A detailed cost analysis will show that the overall cost of performing the operative~     procedure, including transfusions, OR time, and total costs associated with admission cost~     will be more decreased with Amicar as compared to TXA.~   "
117402|NCT02030808|"~     Although the administration of muscle relaxation is essential standard of care for thoracic~     procedures, it could cause long-reversal times and postoperative residual curarization (PORC)~     increasing length of post-anesthesia care unit (PACU) stay and hospital costs. Sugammadex~     offers new perspectives to reduce the incidence of PORC. Unfortunately it is not available in~     many countries because of its significantly high cost. We hypothesized that the use of~     target-controlled remifentanil infusion (TCI) with the non-muscle relaxant (NMR) would be~     associated with comparable surgical conditions and reduced total costs compared with the use~     of neuromuscular blockers during thoracotomy.~      After ethical approval, 66 patients scheduled for elective thoracotomy under sevoflurane~     anesthesia with TCI remifentanil will be included in this prospective, randomized,~     single-blind, controlled study.~      Patients will be randomly assigned to receive cisatracurium or saline (n = 33 for each group)~     throughout the procedure. Laryngoscopy and intubating conditions, intraoperative modified~     thoracic surgery rating scale (Table below), incidence of light anesthesia, and use of~     vasopressors and anesthetics, clinical recovery, incidence of PORC, PACU and hospital stays,~     and total costs will be recorded.~   "
117403|NCT02030795|"~     The use of wire-guided Arndt® endobronchial blocker does not gain widespread acceptance~     during video-assisted thoracoscopy (VATS) because it takes longer time to collapse the~     operative lung especially in patients with chronic obstructive lung disease (COPD). The use~     of a disconnection technique for deflation of Arndt® blocker had a comparable degree of lung~     collapse with the use of double-lumen tubes. However, it carries a risk of blood or infected~     secretions contaminating the dependent lung.~      We hypothesise that the use bronchial suction of through a barrel part of a 1-mL insulin~     syringe attached to the suction port of the bronchial blocker would be associated with~     comparable time to optimum lung collapse with the disconnection technique.~      After ethical approval, 58 patients with spontaneous pneumothorax scheduled for elective VATS~     using Arndt blocker® for lung separation will be included in this prospective, randomized,~     double-blind study.~      Patients will be randomly assigned to deflate the blocker with either disconnecting the~     endotracheal tube from the ventilator for 60 s. prior to inflation of the bronchial blocker~     allowing both lungs to collapse, or attaching -20 cm H2O of suction to the suction port of~     the blocker through the barrel part of a 1-mL insulin syringe (n = 29 for each group).~   "
117404|NCT02030782|"~     This randomized effectiveness trial evaluates a quality improvement intervention aimed at~     providing access to evidence-based depression treatments (particularly cognitive-behavior~     therapy for depression and or pharmacotherapy) through primary care for youth ages 13-21, as~     compared to enhanced usual care. The major hypothesis is that the quality improvement~     intervention will be associated with improved outcomes, relative to enhanced usual care.~   "
117405|NCT02030769|"~     Lugol's solution staining was regarded as a gold standard to detect early superficial lesion~     during esophageal cancer screening using endoscopy. However, the sensitivity and specificity~     were influenced by mucus and food debris of esophagus. Pronase, a kind of protease, was~     previously shown to improve the visibility of gastrointestinal tract. It's unknown if the~     pre-treatment with pronase would also improve the quality of iodine staining in esophagus.A~     randomized double-blind clinical trial was designed to investigate whether or not pronase~     might improve detection rate of early esophageal lesion, especially high grade dysplasia and~     early cancer by improving the esophageal visibility.~   "
117406|NCT02030756|"~     This is a study intended to evaluate the efficacy and safety of the vibrating capsule versus~     sham non-vibrating capsule on spontaneous bowel movement, in aiding reliving Constipated~     Individuals~   "
117407|NCT02030743|"~     The purpose of this study is to determine if training visual attention improves balance and~     mobility, and reduces falls in older adults.~   "
117409|NCT02030717|"~     The study aim to study whether spinal anesthesia (using: bupivacain, morfin och klonidin) can~     be better than epidural anesthesia during and after open surgery for renal cell carcinoma.~     Per- and postoperative pain after spinal anesthesia with klonidin can be reduced and, thus,~     shorten the hospital stay and rehabilitation of the patients.~   "
117411|NCT02030691|"~     Respiratory distress is the main cause of morbimortality in preterm and term neonates. In~     most of the case, these babies required the use of positive end expiratory pressure (PEEP)~     delivered by a non invasive device. Nasal continuous airway positive pressure (nCPAP) is~     widely used in neonatal intensive care unit. Nasal high frequency percussive ventilation~     (nHFPV) can be used as non invasive device to deliver PEEP, and improved lung clearance.~      We hypothesized that nHFPV can be used to deliver PEEP in preterm and term newborn with~     respiratory distress with the same tolerance as nCPAP. To compare the tolerance of these~     devices we used cerebral tissue oxygenation (rSO2c) measured by near infrared spectroscopy~     (NIRS).~   "
117412|NCT02030678|"~     A phase II study of irinotecan in 3 line or more therapy in local recurrence or metastatic~     breast cancer. Evaluate the effect and safety of irinotecan in local recurrence or Metastatic~     breast cancer patients who recieved anthracycline or taxane drugs. The primary endpoint is~     Disease Control Rate and Progression free survival. The second endpoint is 3 or 4 grade~     Adverse Events 、overall survival.All the patients will recieve this therapy till disease~     progress or other occurrence of withdrawal standards.~   "
117413|NCT02030665|"~     Marijuana is the most commonly used illicit drug in the US, but treatment for marijuana~     dependence is not fully effective. In the current proposal we are exploring the idea that~     more tailored teaching of coping skills may result in improved outcomes for~     marijuana-dependence than those seen thus far. Participants will be 275 men and women meeting~     criteria for marijuana dependence and randomly assigned to 9 sessions of treatment in one of~     4 treatment conditions: Standardized MET plus CB (SMET-CB); SMET+ CM (SMET-CB-CM); IATP; or~     IATP + CM (IATP-CM). Patients in all treatments will engage in ES via cell-phone for two~     weeks prior to treatment, for a weekly period during treatment, for another week after~     treatment has ended, and for two weekly periods at months 8 and 14. In the IATP conditions,~     the information gathered from the pretreatment and during-treatment ES periods will provide~     data for a functional analysis of patients' drug use and urges to use. It is hypothesized~     that IATP conditions will yield significantly better coping skills acquisition than SMET-CB~     conditions, both at posttreatment and at extended follow-ups, and that change in coping~     skills will predict better outcomes for the IATP conditions~   "
117414|NCT02030652|"~     The nasal CPAP (continuous positive airway pressure), is a technique of noninvasive~     ventilation commonly used in neonatal intensive care units, and has recently been used in~     association with nasal intermittent mandatory ventilation (NIPPV - intermittent Nasal~     Positive Pressure Ventilation), which consists of the application of respiratory positive~     pressure cycles during the application of nasal CPAP, resulting in high pharyngeal pressures.~     The NIPPV has advantages over traditional CPAP, including the prevention of atelectasis,~     improved respiratory mechanics and decreased work of breathing in premature infants. A~     refinement of this technique is the use of positive pressure breaths associated with nasal~     CPAP synchronously in relation to the newborn's inspiratory effort (SNIPPV - Synchronized~     Nasal Positive Pressure Ventilation).~      Synchronization allows that the cycles of inspiratory positive pressure provided by the~     ventilator coincide with the inspiratory effort, increasing the system efficacy. The Neurally~     Adjusted Ventilatory Assist (NAVA) is a mode of partial ventilatory support based on the use~     of electrical activity of the diaphragm (Edi) to control the mechanical ventilator. The~     ventilatory assistance starts according to respiratory needs of the patient, its use in very~     low birth weight infants showed an improvement in patient-ventilator interaction, even in the~     presence of leak around the endotracheal tube. This prospective randomized, clinical trial~     aims to evaluate, in preterm infants with gestational age lower than 34 weeks with~     respiratory failure treated with noninvasive ventilatory support, the impact of SNIPPV with~     neural adjustment (NAVA) on success ventilation and the need for endotracheal intubation when~     compared to treatment with traditional CPAP.~   "
117415|NCT02030639|"~     The purpose of this study is to gain an understanding of how the experimental anti-cancer~     drug, rigosertib, is metabolized in the body and excreted in the urine and feces after it is~     given as an intravenous infusion. In addition, the study will be carefully monitored to see~     if any side effects occur.~      A radioactive drug is used in this study because it is easier and more accurate to measure~     radioactivity than to use more complicated and less sensitive chemical tests for the drug.~   "
117416|NCT02030626|"~     The present study aims to compare directly the efficacy of two noninvasive neurostimulation~     techniques : repetitive transcranial magnetic stimulation and transcranial direct electrical~     current of the motor cortex in patients with chronic lumbar radiculopathy on pain intensity.~   "
117417|NCT02030613|"~     The purpose of this study is to determine the optimal dosage of etanercept in patients~     treated for idiopathic juvenile arthritis~   "
117418|NCT02030600|"~     This trial is conducted in the United States of America (USA). The aim of the trial is to~     compare the safety and efficacy of insulin degludec (IDeg) and insulin glargine (IGlar) with~     or without OADs (oral anti-diabetic drugs) excluding SUs (sulfonylureas)/glinides in subjects~     with type 2 diabetes.~   "
117419|NCT02030587|"~     This is a prospective randomized controlled study comparing laparoscopic adrenalectomy (LA)~     versus image-guided percutaneous radiofrequency ablation (RFA) in treating~     aldosterone-producing adenoma.~      The objectives of this study are to~        1. compare the short-term outcomes of LA and RFA in treating aldosterone-producing adenoma.~        2. compare the treatment success rates of LA and RFA during follow-up for primary~          aldosteronism.~   "
117420|NCT02030574|"~     The standard treatment of muscle invasive bladder cancer is to administer chemotherapy for~     approximately 3 months then to have surgery to remove the bladder. Chemotherapy may reduce~     the size of the cancer in your bladder before surgery and can also help to reduce the chance~     that your bladder cancer will come back (metastasize) in other parts of your body after~     bladder surgery.~      This study will involve testing cisplatin in lower weekly doses with gemcitabine.The purpose~     of this study is to test the effects, good and bad, of low dose weekly cisplatin and~     gemcitabine.~   "
117421|NCT02030561|"~     This study will determine the safety and efficacy of expanded activated autologous NK cells~     administered after Trastuzumab in patients with HER2-positive breast or gastric cancer. It~     will also provide valuable insights of the role of NK cell infusions in adult solid tumors.~   "
134810|NCT01802762|"~     To assess the feasibility of a new neuromonitoring system (NeMoSystem including NeMo Probe~     and NeMo Patch) and the accuracy of the measurement values (cerebral blood flow (CBF);~     cerebral blood volume (CBV)) obtained.~   "
117424|NCT02030522|"~     This is a prospective cohort treatment intervention study (n=200) whereby U.S. service~     members and veterans with symptoms of PTSD will undergo 2-5 sessions of ART delivered by~     Florida licensed mental health professionals trained in ART. The 3 study aims are to: (i)~     evaluate among U.S. service members and veterans overall, and within specific subgroups, the~     magnitude of change in symptoms of PTSD following treatment with ART; (ii) evaluate the~     sustainability of treatment response with ART; and (iii) evaluate the cost effectiveness of~     ART compared to prolonged exposure (PE) therapy in the treatment of symptoms of PTSD.~   "
117425|NCT02030509|"~     Head and neck cancer would be suitable for quick diagnostic programs because their initial~     symptoms are easy detectable and the curation rates in the initial stages are very high.~      Actually the stages at diagnosis are about 30% in initial stages and 70% in advanced stages.~      The hypothesis of this study is that a program for quick referral of patients with symptoms~     of head and neck cancer would help early diagnosis.~   "
117426|NCT02030496|"~     BACKGROUND:~      Fractures of the distal radius are common and account for an estimated 17% of all fractures~     diagnosed. Two-thirds of these fractures are displaced and require reduction. Although distal~     radius fractures are considered to be relatively harmless, inadequate treatment may result in~     impaired function of the wrist. The consequences of post-traumatic loss of function are~     comprehensive, both on an individual and a social level, and have long been underestimated.~     Despite the substantial implications, no evidence-based treatment method yet exists. Good~     results have been described both in patients treated conservatively and surgically.~     Nevertheless, 60% of all fractures redislocate after conservative treatment at which point~     surgical reduction and fixation is the treatment of choice. Recently, the use of volar~     locking plates has become more popular. This type of osteosynthesis employs a volar approach~     to the wrist and provides immediate stable fixation of the reduced fracture. This stability~     allows for early mobilisation and may therefore result in an improved regain of function. The~     aim of this study is to compare the functional outcome following surgical reduction and~     fixation with a volar locking plate with the functional outcome following closed reduction~     and plaster immobilisation at one year follow-up in patients with displaced extra-articular~     distal radius fractures.~      DESIGN:~      This single blinded randomised controlled trial will randomise between open reduction and~     internal fixation with a volar locking plate (intervention group) and closed reduction~     followed by plaster immobilisation (control group). The study population will consist of all~     consecutive adult patients who are diagnosed with a displaced extra-articular distal radius~     fracture which has been adequately reduced at the Emergency Department. The primary outcome~     (functional outcome) will be assessed by means of the Disability Arm Shoulder Hand Score~     (DASH). Since the treatment allocated involves a surgical procedure, randomisation status~     will not be blinded. However, the researcher assessing the outcome at one year will be~     unaware of the treatment allocation. In total, 90 patients will be included in this trial~     which will be conducted in the Academic Medical Centre Amsterdam and its partners of the~     regional trauma care network.~   "
117427|NCT02030483|"~     Our hypothesis is that treating relapsed or refractory multiple myeloma with PD 0332991~     (Palbociclib) in combination with lenalidomide will result will be both effectively inducing~     myeloma plasma cell death as well maintaining a favorable side effect profile.~   "
117428|NCT02030470|"~     Periodontitis are infectious and inflammatory diseases of gum and tooth supporting tissues~     leading to tooth loss and oral disability. Twenty to 30 percents of patients treated for~     periodontal diseases display more or less pronounced persistence of periodontal tissue~     infection, inflammation, and destruction. The therapeutic additional value of photodynamic~     anti-infectious treatment remains controversial. The objective of this study is to evaluate~     the mid-term effect of the photodynamic device Fotosan®630 on severe periodontitis treatment~     outcomes and to define its specific therapeutic indications.~   "
117429|NCT02030457|"~     This study is designed to compare the systemic exposure of orally inhaled beclomethasone~     dipropionate inhalation aerosol delivered via BAI to that delivered via MDI.~   "
117430|NCT02030444|"~     The overall aim of this study is to compare standard staging of lung cancer (which includes~     clinical examination, CT, MRI, bone scan and PET-CT) with comprehensive staging - which~     includes the new staging methods (PET-MRI and systematic mapping of mediastinal and hilar~     lymph nodes using endobronchial ultrasound) with respect to disease stage and outcomes of~     therapy.~   "
117431|NCT02030431|"~     A prospective, randomized study comparing the effectiveness of a new system, Dynaloc compared~     with three cancellous screws, for osteosynthesis of femoral neck fractures~   "
117432|NCT02030418|"~     Prospective, non-randomized, single-arm, international multicenter, clinical safety and~     effectiveness of a leadless pacemaker system in patients who are indicated for a VVIR~     pacemaker.~      Following completion of enrollments in the IDE, patients will continue to be enrolled in the~     continued access phase of the study under the same protocol.~   "
117433|NCT02030405|"~     This phase 2 trial studies how well ixazomib(MLN9708) works in treating patients with~     relapsed or refractory acute myeloid leukemia. Ixazomib may stop the growth of cancer cells~     by blocking some of the enzymes needed for cell growth.~   "
117434|NCT02030392|"~     This trial aims to compare two training programs for children suffering functional abdominal~     pain. These two programs are comparable in number of sessions and group sizes, but show~     differences in content (very focused on pain management vs. more general information and~     support). Focus of the trial is the evaluation of Stop the pain, which has shown high~     effectiveness in one first trial. This time, five clinics, experienced in diagnosis and~     treatment of childhood chronic abdominal pain, will take part. Children aged 7-12 years are~     eligible. The programs imply six weekly group sessions for the children and 2 parent~     evenings. The study group assumes that participation in Stop the pain will reduce pain~     experience and will improve the children's quality of life and coping strategies - up to 12~     months after training.~   "
117435|NCT02030379|"~     The investigators will leverage e-technologies to provide an online version of the Question~     Prompt LIst (QPL-CT), that patients access via available iPads, enabling both the real-time~     prioritizing of patient questions as well as the seamless delivery of these questions to~     their treating physician (and other members of their clinical team) via the VCU Health System~     (VCUHS) patient portal, and the electronic medical record (EMR) prior to a consultation to~     discuss a clinical trial~   "
117436|NCT02030366|"~     Traumatic Brain Injury (TBI) is a common injury in combat, terrorist attacks and sports such~     as football and hockey. Unnecessary delays in the diagnosis and treatment of brain damage in~     patients who can benefit from evacuation procedures can lead to worse brain injury, worse~     outcome and, sometimes, unnecessary death. However, there is no reliable and sensitive method~     for diagnosis of TBI severity in the field. In this study we will examine the feasibility of~     using this a multifocal chromatic pupillometer for monitoring TBI, by examining the pupillary~     response to multifocal chromatic stimuli in intracranial pressure (ICP)-monitored severe TBI~     patients. As control, normal subjects will be tested for pupillary responses using this~     device.~   "
135089|NCT01799083|"~     Determine alone or in combination with chemotherapy or autologous cytokine induced killer~     cells are effective and safe in the treatment of patients with relapsed and/or refractory~     solid tumors or B Cell lymphomas.~   "
117437|NCT02030353|"~     The purpose of this study is to test the feasibility of two 6-month behavioral interventions~     for weight gain prevention (self-regulation plus activity monitoring or self-regulation)~     among African American breast cancer survivors along with a delayed control group.~     Participants will be 45 African American post-treatment breast cancer survivors. Intervention~     content will be delivered online with one face-to-face individual meeting. Weight, clinical~     and psychosocial measures will be assessed at baseline, 3 and 6 months. It is hypothesized~     that it is feasible to deliver the two weight gain prevention interventions among African~     American breast cancer survivors, and participants in the two intervention groups will have a~     lower magnitude of weight gain at 6-month follow-up relative to those in the delayed control~     group.~   "
117438|NCT02030340|"~     Various systems to measure intravesical and intrarectal pressure during urodynamic testing;~     especially cystometry, exist. Water filled tube -systems are the most commonly used and~     should be regarded as the contemporary standard. A water filled system is however sensitive~     to tube and or patient movement artefacts and prone to erroneous calibration. Air charged~     catheters are less sensitive to patient and especially tubing- movements, and calibrate~     easier. However, in vitro tests have demonstrated that air charged catheters respond somewhat~     slower and relatively damped, especially to rapid pressure changes as in (simulated)~     coughing, in comparison with water filled systems. The clinical relevance of these~     observations is unknown.~      This is a study to compare the technical reliability and clinical applicability of the two~     types of catheter systems for cystometry in a synchronous double catheter testing procedure~     in a prospective group or patients scheduled for urodynamic investigation.~   "
117439|NCT02030327|"~     To analyse differences in protein expression in multiple trauma patients for identification~     of potential biomarkers to predict organ dysfunction.~   "
117440|NCT02030314|"~     Chlorthalidone might offer an effective, safe and inexpensive anti-hypertensive treatment for~     kidney transplant patients who have resistant hypertension on multi-drug therapy. We will~     collect initial data on the safety and efficacy of Chlorthalidone in the treatment of~     patients with resistant hypertension.~      To Examine the efficacy of chlorthalidone as an anti-hypertensive agent in the treatment of~     resistant hypertension among stable kidney transplant recipients~   "
117441|NCT02030301|"~     The purpose of this study is to test the safety and effectiveness of two experimental~     therapeutic vaccines against herpes simplex virus, type 2 (HSV-2).~   "
117442|NCT02030288|"~     This project will involve the development and initial evaluation of a promising~     computer-based intervention to improve the primary care management of risky alcohol use among~     Veterans. The intervention uses a Relational Agent, an on-screen person that establishes a~     relationship with the Veteran to promote positive health behaviors. This study will determine~     how Veterans interact with this system, how it can be tailored to Veterans' preferences, and~     its potential effect on risky drinking. If ultimately proven effective, the Relational Agent~     will have several impacts on Veterans and their health care, including:~        -  (1) lower rates of risky drinking in Veterans~        -  (2) improved rates of brief counseling for Veterans with excessive alcohol use~        -  (3) increased proportion of Veterans referred to Mental Health for alcohol disorders~        -  (4) improved care for Veterans with low levels of health literacy.~      This study directly supports Secretary Shinseki's Transformational Initiative to employ~     state-of-the-art information technology to improve quality and access of Veterans' health~     care.~   "
117443|NCT02030275|"~     The purpose of this study is to determine the effectiveness of RXI-109 in reducing the~     recurrence of hypertrophic scar formation following elective revision of a pre-existing~     hypertrophic abdominal scar.~   "
117444|NCT02030262|"~     The purpose of this study is to determine if one of these gaz (air and sulfur hexafluoride)~     is better than the other in epiretinal membrane peeling surgery. Both are already used for~     this surgery and this study will tell us if one is better than the other.~   "
117445|NCT02030249|"~     The aim of this study is to investigate possible enduring effects of a standard 2-month~     weight loss program on appetite regulation, bone homeostasis and muscle strength in younger~     and older adults, as well as the impact of differences in dietary composition during weight~     maintenance.~   "
117446|NCT02030236|"~     Cooling the whole body to 32-34 degrees Centigrade from the normal of around 37 degrees~     Centigrade for 24 hours has been shown to be an effective way of reducing damage to brain~     function after return of spontaneous circulation when someone has been resuscitated from~     cardiac arrest. Cardiac arrest is a form of heart attack where the heart stops pumping.~      The device is a prototype cooling vest. The investigators anticipate that this will be useful~     in ambulances, helicopters and emergency departments where there is a need for a portable,~     safe, easy-to-use, inexpensive, external, effective, readily-controlled and single-patient~     use device able to reduce body temperature by at least 1 degree Centigrade an hour to~     initiate cooling. What the investigators are doing in these trials is to demonstrate that the~     investigators can cool people and to get the best design possible for patient use. That means~     some of the initial prototypes will not resemble what we expect the eventual device to look~     like. The investigators will be undertaking the initial trials on 30 normal volunteers.~   "
117447|NCT02030223|"~     This prospective, randomized, double blinded, placebo-controlled study is designed to~     evaluate the postoperative analgesic efficacy of the ultrasound-guided transversus abdominis~     plane block with ropivacaine 0,75 %, in patients undergoing unilateral inguinal hernia repair~     with a mesh under general anaesthesia, and how the efficiency of early postoperative~     analgesia achieved correlates with the risk of developing a chronic pain state, a not~     uncommon condition after this type of surgery.~   "
117448|NCT02030210|"~     RAND/UCLA modified Delphi study on quality indicators for STEMI to determine the~     appropriateness of quality indicators retrieved from literature and guideline review. We aim~     to engage 20 cardiologists and 20 nurses with relevant experience in the care for STEMI~     patients.~   "
117449|NCT02030197|"~     The purpose of this study is to examine the effects of an innovative program, entitled CRISP~     (Community Integration for Socially Isolated Patients), on improving self-efficacy and~     assessing whether improved self-efficacy helps to reduce depression and loneliness of people~     with MS.~   "
119236|NCT02006836|"~     Food intake has a great influence on blood glucose of patients with diabetes. This study was~     designed to determine the glycemic index (GI) of a particular pomelo named Majia pomelo and~     its effects on postprandial glucose (PPG) excursions in both healthy subjects and patients~     with type 2 diabetes (T2DM).~   "
117450|NCT02030184|"~     There are two parts to this trial. The first study will evaluate increasing doses of Re188~     P2045 in patients with advanced small cell lung cancer that has recurred after initial~     therapy or in patients with other advanced neuroendocrine cancers that have progressed after~     therapy.~      Re188 P2045 is designed to attach to type 2 somatostatin receptors that are frequently~     expressed in those cancers and then the radioactivity from Re188 will kill the cancer cell.~     Only patients who have cancers that can be seen when Tc99 P2045 is administered (also seeks~     out the SSTR2, but Tc99 images, but does not treat the cells) will be treated.~      Therefore, this approach maximizes the possibility that patients will benefit from treatment~     in that only those who have cancers that have the target will undergo treatment. The primary~     purpose of this study will be to determine the highest dose of Re188 P2045 that can be safely~     administered.~      The second study will open after the conclusion of the first. Patients will first undergo the~     scan with Tc99 P2045 and then be treated with topotecan for three days. Topotecan is a~     standard chemotherapy drug that is approved for second line therapy for small cell and~     frequently used for other neuroendocrine cancers. Following that, patients will then be~     re-evaluated with the Tc99 P2045 scan and if it demonstrates that the tumor is positive for~     SSTR2, then patients will receive Re188 P2045. The goal of this study is to determine the~     highest dose of Re188 P2045 that can be safely administered after topotecan as well as to~     determine if topotecan will increase the chance that the tumor will express SSTR2.~   "
117451|NCT02030171|"~     Effect of three therapeutics strategies on the restriction of the participation of patients~     with a chronic back pain : multidisciplinary is it the key component ?~   "
117452|NCT02030158|"~     This is the statistical analysis plan for an individual patient data meta-analysis (IPDMA) of~     three EGDT clinical trials.~   "
117453|NCT02030145|"~     The primary goal of this line of research is to see if realistic manipulative protocols can~     be developed to produce sustained reductions in residual volume and improve pulmonary~     function parameters in people with Chronic Obstructive Pulmonary Disease (COPD).~   "
117454|NCT02030132|"~     Employers are increasingly looking for opportunities to motivate sedentary employees to~     become more physically active. Workplace walking programs have had mixed success and~     typically show most improvement among participants that are already fairly active at a~     baseline. The goal of this study is to determine whether a financial incentive program can~     motivate sedentary employees to increase the number of steps they walk per day to meet a~     minimum threshold.~      The primary outcome measure is the proportion of days a minimum activity of 7000 steps or~     more is achieved. Outcomes will be assessed each week for 3 months using incentives followed~     by 3 months of follow-up without incentives. Secondary outcomes will include the average~     steps walked per day.~   "
117455|NCT02030119|"~     Employers are increasingly looking for opportunities to motivate sedentary employees to~     become more physically active. Workplace walking programs have had mixed success and~     typically show most improvement among participants that are already fairly active at a~     baseline. The goal of this study is to determine whether a financial incentive program can~     motivate sedentary employees to increase the number of steps they walk per day to meet a~     minimum threshold.~      The primary outcome measure is the proportion of days a minimum activity of 7000 steps or~     more is achieved. Outcomes will be assessed each week for 3 months using incentives followed~     by 3 months of follow-up without incentives. Secondary outcomes will include the average~     steps walked per day.~   "
117456|NCT02030106|"~     This is a prospective cohort, enriched with women with a prior term birth, of singleton~     pregnancies who will be followed for the outcome of preterm birth. The main exposure of~     interest is the characterization of the cervico-vaginal microbiota. Women will be recruited~     from a population seeking routine obstetrical care at obstetrical practices at Penn. They~     will have three research visits during pregnancy to complete questionnaires and collect~     samples of cervico-vaginal fluid and cervical cells. Outcome data will be collected about the~     prenatal events and timing of delivery.~   "
117457|NCT02030093|"~     Alcohol dependency is the second most common psychiatric disorder and a major public health~     concern. As addictive disorders and now thought to be chronic disorders for many patients~     there is a need for the development of expanded treatment approaches. Because relapse is more~     often the rule than the exception the importance of continuing care after an initial phase of~     treatment is evident. Studies investigating telephone-based continuing care for patients with~     alcohol dependence have shown to be an effective form of step-down treatment after a previous~     stabilisation treatment program and provide extended recovery support. Therefore, the~     investigators hypothesize that alcohol abstinent patients who received high-frequency~     telephone-based or sms-based continuing care show significantly less relapses respectively~     more abstinent days six and twelve months after in-patient treatment compared to patients who~     receive low-frequency or no telephone-based continuing care.~   "
117458|NCT02030080|"~     Employers are increasingly looking for opportunities to motivate sedentary employees to~     become more physically active. Workplace walking programs have had mixed success and~     typically show most improvement among participants that are already fairly active at a~     baseline. The goal of this study is to determine whether a financial incentive program can~     motivate sedentary employees to increase the number of steps they walk per day to meet a~     minimum threshold.~      The primary outcome measure is the proportion of days a minimum activity of 7000 steps or~     more is achieved. Outcomes will be assessed each week for 3 months using incentives followed~     by 3 months of follow-up without incentives. Secondary outcomes will include the average~     steps walked per day.~   "
117459|NCT02030067|"~     The purpose of this study is to determine the maximum tolerated dose of RX-3117 in subjects~     with advanced or metastatic solid tumors (Phase 1). The purpose of the Phase 2 portion is to~     estimate anti-tumor activity in subjects with advanced malignancies (relapsed or refractory~     pancreatic or advanced bladder cancer).~   "
117468|NCT02029950|"~     This phase I trial studies the side effects and best dose of pomalidomide after combination~     chemotherapy in treating patients with newly diagnosed acute myeloid leukemia or high-risk~     myelodysplastic syndrome. Drugs used in chemotherapy, such as cytarabine, daunorubicin~     hydrochloride, and etoposide, work in different ways to stop the growth of cancer cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Pomalidomide may kill cancer cells by stopping blood flow to the cancer and by~     stimulating white blood cells to kill cancer cells. Giving more than one drug (combination~     chemotherapy) and pomalidomide may kill more cancer cells.~   "
117460|NCT02030054|"~     Statin interference has been suggested among the mechanisms of reduction of the antiplatelet~     effect of clopidogrel. The purpose of this study is to evaluate pharmacodynamic effects of~     rosuvastatin and atorvastatin on platelet reactivity in patients with coronary artery disease~     undergone double antiplatelet therapy with new P2Y12 inhibitors. This is a single-center,~     prospective, randomized, crossover study conducted in the Department of Heart and Great~     Vessels Attilio Reale, Sapienza University, Rome, Italy. All consecutive patients undergone~     PTCA in our institution in the period between July 2013 and December 2013 will be eligible to~     be enrolled.~      Patients will be offered to participate to the trial at time of 1-month post-angioplasty~     follow-up visit.patients receiving dual antiplatelet therapy (prasugrel 10 mg or brilique 90~     mg x 2 plus aspirin 100 mg) after percutaneous coronary intervention. Patients were randomly~     assigned to rosuvastatin (20 mg day) or atorvastatin (40 mg day) for 30 days. After 1-week~     wash-out period to avoid any carryover effect, cross-over was performed, and patients were~     switched to the other drug which was continued for 30 days.~      Platelet function will be evaluated using a validated method: the VerifyNow System~     (Accumetrics Inc., San Diego, CA), which is a point-of-care turbidimetry-based optical~     detection system that measures platelet-induced aggregation. Platelet function will be~     measured with the VerifyNow P2Y12 test at baseline and after 30 days from rosuvastatin or~     atorvastatin administration.~      Platelet reactivity will be expressed in P2Y12 reaction units (PRU). PRU values >208 are~     suggestive of high platelet reactivity.~   "
117461|NCT02030041|"~     Statins along with lifestyle modifications including exercise are commonly prescribed to~     patients with type 2 diabetes. American diabetes association recommends using~     moderate-intensity statin and lifestyle therapy for patients with diabetes aged ≥40 years,~     even without additional cardiovascular disease(CVD) risk factors.. Myopathy is a well known~     adverse effect of statins, which occurs in 1-7% of patients. The spectrum of statin-related~     myopathy ranges from common benign myalgia to rare but life threatening rhabdomyolysis. Being~     lipophilic, simvastatin diffuses nonselectively into extrahepatic tissues such as muscle,~     leading to higher incidence of myopathy among statin users.~      In addition, simvastatin attenuates the exercise-induced increase in cardiorespiratory~     fitness, and reduces the skeletal muscle mitochondrial content and oxidative capacity in~     humans. Impaired cardiorespiratory fitness and mitochondrial function is possibly due to~     reduction in Coenzyme Q10, which is a component of the electron transport chain and is~     indispensable for generation of adenosine triphosphate (ATP) during oxidative phosphorylation~     in mitochondria. Statins or hydroxyl-methylglutaryl coenzyme A (HMA CoA) reductase inhibitors~     interfere with the production of mevalonic acid, which is a precursor in the synthesis of~     coenzyme Q10.~      Mitochondrial dysfunction has also been reported in vitamin D deficient individuals which has~     been attributed to intra-mitochondrial calcium deficiency or deficient enzyme function of the~     oxidative pathway ( by direct effect of vitamin D on enzyme gene or protein expression).~     Thus, vitamin D may improve the statin-mediated changes in cardiorespiratory fitness and~     mitochondrial function by improving the enzymatic machinery involved in oxidative~     phosphorylation which is blocked by statin. This study is being done to look for the effect~     of vitamin D supplementation on simvastatin-mediated change in exercise-mediated~     cardiorespiratory fitness and skeletal muscle mitochondrial content in adults with type 2~     diabetes~   "
117462|NCT02030028|"~     The purpose of this research study is to evaluate if the study drug, ACTH Gel helps decrease~     the disease symptoms in people with Rheumatoid Arthritis (RA) who are already taking~     medications prescribed by their physician and are still experiencing disease symptoms.~      ACTH gel has been a Food and Drug Administration-approved treatment for Rheumatoid Arthritis~     since 1952, and in 2010 the FDA retained RA as a disease approved for ACTH gel use. Despite~     its FDA approval there is very limited data on its how well ACTH gel works in improving the~     symptoms of people with RA.~   "
117463|NCT02030015|"~     The investigators hypothesize that a combination therapy using miglustat and the ketogenic~     diet for infantile and juvenile patients with gangliosidoses will create a synergy that 1)~     improves overall survival for patients with infantile or juvenile gangliosidoses, and 2)~     improves neurodevelopmental clinical outcomes of therapy, compared to data reported in~     previous natural history studies. The ketogenic diet is indicated for management of seizures~     in patients with seizure disorders. In this study, the ketogenic diet will be used to~     minimize or prevent gastrointestinal side-effects of miglustat. A Sandhoff disease mouse~     study has shown that the ketogenic diet may also improve central nervous system response to~     miglustat therapy (see Denny in Citations list below). Patients with infantile and juvenile~     gangliosidoses commonly suffer from seizure disorders, and use of the ketogenic diet in these~     patients may therefore also improve seizure management.~   "
117464|NCT02030002|"~     The purpose of this study is to compare bonding time, bond survival, amount of adhesive~     remaining on the tooth surface after bracket debonding, and time required for adhesive~     remnant cleanup between a new flash-free and a conventional adhesive resin for orthodontic~     bracket bonding.~   "
117465|NCT02029989|"~     The study was a 12-month, multi-centered, quasi-experimental design to assess point-of-care~     (POCT) screening/monitoring of subjects on antipsychotic agents for metabolic syndrome.~     Subjects were also randomized to either an Extended Treatment Group (ETG) defined by~     receiving comprehensive medication management (CMM) pharmacist interventions or a Usual~     Treatment Group (UTG) receiving no CMM interventions. All subjects were recruited from three~     community mental health clinic settings in Minnesota.~   "
117466|NCT02029976|"~     Primary Aim: To test the efficacy of an elementary school-based, school nurse-led weight~     management program to reduce excess weight gain among children, 8 to 12 years old who are~     overweight and at risk of overweight by increasing healthy dietary practices and physical~     activity levels and decreasing sedentary practices.~      Primary Hypothesis: Relative to the control condition, the children receiving the~     intervention will have a significantly lower body mass index (BMI), following implementation~     of the 9-month intervention, controlling for baseline values.~   "
117467|NCT02029963|"~     The purpose of this study is to investigate the use of repetitive transcranial magnetic~     stimulation (rTMS) in helping to prevent relapse in major depressive disorder. rTMS is known~     to be an effective treatment for major depressive disorder, but there is also evidence that~     it may be effective in the maintenance of remission following treatment. However, it is not~     yet clear what maintenance strategy will yield the best outcome in preventing relapse.~      In this study, eligible patients who have finished one full course of rTMS for treatment of~     major depression will be randomized into three groups: (i) cluster rTMS, (ii) taper rTMS, and~     (iii) treatment as usual. The 'cluster rTMS' group will receive two weeks to daily rTMS six~     months after the completion of their regular rTMS treatment, the 'taper rTMS' group will~     receive three sessions a week for two weeks followed by two sessions a week for two weeks~     immediately following their regular rTMS treatment, while the 'treatment as usual' group will~     receive standard follow-up care from their own psychiatrist and/or primary care doctor.~      The investigators hypothesize that the group with cluster treatment will show significantly~     lower relapse rates in depressive symptoms as compared to the other groups.~   "
117469|NCT02029937|"~     The overall objective of this multicenter trial is to determine whether the use of a~     low-cost, high-resolution microendoscope during diagnostic upper endoscopy can improve the~     efficiency and accuracy of endoscopic screening for esophageal squamous cell neoplasia. This~     is a multicenter clinical trial of a novel technology, a miniaturized, lower cost (< $3, 500)~     microscope device which can be used during upper endoscopy to image the gastrointestinal~     epithelium. This high-resolution microendoscope (HRME) was developed by our collaborators at~     RICE University and provides >1000X magnified images of the esophageal mucosa.~   "
117470|NCT02029924|"~     The addition of Biochaperone to insulin lispro may accelerate the onset and shorten the~     duration of action of insulin lispro due to a facilitation of the absorption of the insulin~     after subcutaneous injection.~      The aim of the trial is to assess the efficacy and safety of BioChaperone insulin lispro in~     subjects with Type 1 diabetes under a dose of 0.2 U/Kg.~      This trial is a single-center, randomised, double-blinded, two-treatment, two-period~     cross-over, 6-hour euglycaemic glucose clamp trial in subjects with Type 1 diabetes mellitus.~     Each subject will be randomly allocated to a single dose of BioChaperone insulin lispro 0.2~     U/Kg and a single dose of Humalog® 0.2 U/Kg on 2 separate dosing visits.~   "
117471|NCT02029911|"~     This is a multi-center, single-arm, non-randomized, prospective clinical study. The clinical~     study is designed as a non-inferiority study to assess the effectiveness of the Aurora~     Endometrial Ablation System compared to an objective standard. Safety will be evaluated by~     determining the number and percentage of subjects who experience one or more of serious~     adverse events.~   "
117472|NCT02029898|"~     One of the problems during general anesthesia (GA) for caesarean section is the place of~     opioid agents. Indeed, the literature does not provide so far a clear answer regarding the~     use of opioids prior to extraction of the newborn. Indeed, if the opioid administration at~     induction is beneficial for the mother (better control of autonomic responses to noxious~     stimuli), the impact on the newborn can be unfavorable in terms of adaptation to extrauterine~     life . This is especially true if the birth takes place in a context of prematurity and / or~     acute fetal distress.~      The pharmacokinetics of remifentanil make it the only opioid which is consistent with a rapid~     sequence induction. Its short period of action avoids the manual ventilation of patients~     before intubation, while providing a peak of action concomitant to the nociceptive~     stimulation. Patients at high risk of aspiration, including pregnant women, may benefit from~     this type of morphine at induction. In addition, the fact that remifentanil seems to be~     associated with relative fetal safety in obstetrical or neonatal context legitimized the~     development of protocols to study maternal-fetal consequences of the use of remifentanil at~     induction of AG for emergency caesarean section.~      While cesarean section under general anesthesia mainly concern premature newborns in France,~     no work has focused on the use of remifentanil for caesarean section in a context of preterm~     without preeclampsia.~      The main hypothesis of this study is to evaluate the safety of the use of remifentanil in~     terms of adaptation to extrauterine life in children born prematurely by caesarean section~     under general anesthesia outside the context of preeclampsia.~      To do this, we will compare two groups of children, one consisting of children born by~     cesarean section under general anesthesia with maternal remifentanil infusion, the other made~     up of children born by cesarean section under general anesthesia without maternal infusion of~     remifentanil. This study is prospective, single-center, randomized, double-blinded.~      The primary endpoint is formed by the value of the Apgar score less than 7 at 5 minutes,~     calculated in the delivery room by the team supporting the child (midwives and~     pediatricians).~      The secondary endpoints are formed by maternal hemodynamic parameters (SBP, DBP, MAP, HR),~     the rate of complications during induction (difficult intubation, aspiration), the onset of~     respiratory distress requiring ventilation mask in the newborn, the rate of intubation in~     neonates, and the rate of use of adjuvant anesthetic agents.~   "
117473|NCT02029885|"~     To demonstrate that non-invasive renal denervation is safe and shows a net difference in~     blood pressure reduction when compared to sham in subjects with uncontrolled hypertension.~   "
117474|NCT02029872|"~     This research is being done to learn more about an approach to remove Methicillin resistant~     Staphylococcus aureus (MRSA) in patients who are carriers of the bacteria in outpatient~     settings and among their household members and sexual partners.~      MRSA is a type of bacteria or germ that can cause bad infections of the skin that can make~     people very sick. The bacteria have been seen in a high number of persons in the Baltimore~     area and in hospitals throughout the country. MRSA can be spread from person to person,~     particularly in homes and among family members and sexual partners.~      There are three things the investigators hope to learn from this research study:~      First, the investigators want to find a way to prevent MRSA infections in outpatient~     settings. By asking questions, the investigators want to look at the things that may increase~     the risk of having this type of bacteria in you and your family members.~      Second, the investigators have soaps and oral rinses (Chlorhexidine) and medications~     (antibiotics; Mupirocin ointment) that have been shown to be effective at removing MRSA. The~     investigators want to determine if these antibiotics and soaps are best used for everyone in~     the household or only the individual with known MRSA.~      Third, as the investigators, we want to learn more about the bacteria by looking at it on the~     inside. The investigators will do laboratory tests on samples we collect, to learn how MRSA~     bacteria grow, reproduce and how it develops to behave differently than other types of MRSA~     bacteria.~   "
117475|NCT02029859|"~     Main objective:~      Determine the prevalence of obstructive sleep apnea syndrome (OSA) in late pregnancy in a~     population of obese patients .~      Secondary objectives :~        -  Identify risk factors for OSA during pregnancy (age, parity, high blood pressure,~          snoring , weight, neck circumference, scores on symptoms of sleep apnea, ... ) .~        -  Compare perinatal morbidity among obese patients with OSA in late pregnancy with~          case-controls.~        -  Evaluate the evolution of a moderate or severe OSA 6 months after pregnancy.~      Material and methods~      Characteristics of the study:~        -  Interventional biomedical research~        -  Prospective Multicenter nonrandomized study~      Flow chart~        -  Patients will be included between 30 and 36 weeks of amenorrhea (WA) .~        -  Will rated from inclusion: age, parity, weight, height, BMI in early pregnancy, neck~          circumferrence, treated high blood pressure.~        -  As recommended in France, the main test results during the pregnancy follow-up will be~          recorded.~        -  At the inclusion visit will be conducted a Berlin Questionnaire and Epworth Score.~        -  Screening for OSA by nocturnal polysomnography will be performed between 30 and 36WA.~          This screening can be performed as an outpatient.~        -  In case of proven OSA patients will be offered an appropriate care by today's standards.~        -  Whatever the outcome of pregnancy, a second polysomnography will be performed 6 months~          after childbirth in case of OSA during pregnancy.~   "
117476|NCT02029846|"~     This study is a pilot randomized controlled trial of 30 elderly type 2 diabetes patients~     conducted at the MODEL Clinical Research (MODEL), Research Division of Bay West Endocrinology~     Associates in Baltimore, Maryland. The investigators hypothesized that compared to a regimen~     base solely on traditional drugs, a regimen including newer drugs will achieve glycemic~     target faster and induce less hypoglycemia, weight gain, and other side effects, over the~     short run.~   "
117576|NCT02028546|"~     The purpose of this study is to determine the hydration effect of various regimens of skin~     bathing and moisturizer application on atopic dermatitis~   "
117477|NCT02029833|"~     The objectives of the study are to examine the health benefits of dietary canola oils on body~     composition, specifically on android fat, and weight management. COMIT II will also include~     analysis of FAEs to elucidate the mechanisms by which canola oil may be modifying body~     composition. Measurement of endothelial function, inflammatory, adiposity, and insulin~     sensitivity biomarkers will be done to determine the positive health impact of the changes in~     body composition achieved through canola oil consumption.~   "
117478|NCT02029820|"~     The purpose of this study is to determine whether hydration with intravenous saline matched~     with urine output, using the device RenalGuard is superior to standard hydration with saline~     to prevent contrast-induced nephropathy.~   "
117479|NCT02029807|"~     The investigators have developed a system based on a pulse oximeter, a tablet, and an~     algorithm running on the tablet that analyzes the pulse oximeter waveform.~      The algorithm that runs on this system should be able to accurately keep track of blood loss~     during blood donation. The investigators will compare the algorithm with the blood loss~     tracked by a device called a flow meter.~      The algorithm that runs on this system should be able to accurately keep track of stroke~     volume changes. The investigators will compare the algorithm with the stroke volume changes~     tracked by a device called a CCNexfin.~      The algorithm that runs on this system should work whether it's in place for the whole blood~     donation, or if it's placed after the blood donation has started. The investigators will use~     two pulse oximeters for the system on each hand and compare one that is used for the whole~     blood donation versus one that is not used for the whole blood donation.~   "
117480|NCT02029794|"~     Cervical cancer remains a public health burden, particularly in developing countries such as~     sub-saharan Africa where the infrastructure for organized screening programs does not exist.~     As a result, other screening modalities (visual inspection with acetic acid) are the standard~     of care in such regions. It is now known, persistent infection with an oncogenic Human~     papillomavirus (HPV) type is a necessary precursor of cervical cancer and evidence is showing~     HPV testing is a potential, safe and effective alternative to cytology testing (The Pap~     smear). This study is evaluating the feasibility and acceptance of HPV self-collection vs.~     VIA in a cohort of women from Kisenyi, Uganda.~   "
117481|NCT02029781|"~     SUMMARY~      Rationale: A diagnostic laparoscopy is a frequently used method to confirm the diagnosis~     appendicitis. However until recently evidence-based laparoscopic criteria for determining~     appendicitis were not defined. If there is any doubt about the presence of appendicitis the~     appendix is usually removed. In a single centre prospective pilot study on 134 patients the~     investigators were able to define the Laparoscopic APPendicitis (LAPP) score. In the current~     study the investigators will validate the LAPP score in order to decrease the negative~     appendectomy rate by 50%. Eventually the score should lead to a decrease in morbidity.~      Objective: To decrease the negative appendectomy rate by 50%.~      Study design: A multicenter prospective validation study~      Study population: All patients, ≥18 years, operated with a diagnostic laparoscopy for the~     clinical suspicion appendicitis. Sample size calculation, performed by a statistician/~     epidemiologist of the Trial Coordination Centre, showed the need to analyse 778 patients.~      Intervention (if applicable): Patients operated on appendicitis in 2008 and 2009 (n=843),~     were retrospectively analysed for negative appendectomies. This cohort will serve as the~     control group. In this control group no intervention was given, as the LAPP score was not yet~     defined.~      In the 778 prospective analysed patients, the LAPP score will be used during a diagnostic~     laparoscopy. With the LAPP score the investigators intend to halve the number of negative~     appendectomies.~      Main study parameters/endpoints: A decrease in the negative appendectomy rate from 9% to 5%.~     This decrease should not lead to an increase in missed appendicitis (occurring within 30~     days), defined as requiring a surgical re-intervention or as an appendicitis or appendicular~     infiltrate on an ultrasound or CT-scan.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: The risk of implementation of the LAPP score is minimal. In theory, the use of~     the LAPP score might lead to an increase risk in missed appendicitis. This might lead to an~     increase in morbidity.~   "
117482|NCT02029768|"~     Hypothesis 1: A quantifiable difference in inflammatory cytokines exist in women with burn~     injury and this correlates with clinical markers of outcome~      Hypothesis 2: The amount of adipose tissue contributes to the severity of cellular immune~     response (CMI) dysregulation in response to burn injury~      Skin-fold caliper measurements will be taken on consented patients (both male and female) to~     determine body fat percentage. Serum samples will be obtained from these patients. The level~     of inflammatory cytokines in the serum will be measured to determine if there is a link~     between body fat percentage, pro-inflammatory cytokines and the ability of women to survive~     burn injury.~   "
117483|NCT02029755|"~     Postoperative analgesia is an important part of the anesthetic care. According to the recent~     studies, multimodal analgesia can provide better analgesia & patient satisfaction with fewer~     side effect. For example, combining intravenous, intramuscular or oral analgesics with~     transversus abdominis plane (TAP) block or local anesthetic (LA) infiltration as the~     multimodal analgesia, can furnish a more effective pain control after the abdominal surgery.~      For abdominal surgery, both local infiltration and TAP block target on relieving somatic~     pain. Local anesthetic wound infiltration is easy to perform with low risk. As the~     advancement of ultrasound technology, performing the TAP block also becomes easier, safer and~     more accurate. But whether LA infiltration or TAP block is better for the multimodal~     analgesia regimen remains unclear.~      This study is to compare the postoperative pain score, opioid consumption, side effects, and~     quality of recovery between these two analgesic methods in patients undergoing abdominal~     surgery. The investigators hypothesized that TAP block may be more effective than LA~     infiltration as a part of the multimodal analgesia, and can improve the recovery after the~     abdominal surgery.~   "
117484|NCT02029742|"~     The investigators propose that culturally aligned community-based interventions in our~     multi-ethnic sickle cell disease (SCD) population, augmented by task-focused communication~     technology, can improve self-managed adherence to hydroxyurea (HU) by decreasing barriers to~     use, supporting parent-youth partnerships for chronic disease self-management and reinforcing~     the behavior of daily medication use. Culturally aligned community health workers (CHW) are a~     well-established means to support chronic disease self-management by underserved families, in~     partnership with medical homes. CHWs can identify and address multiple barriers and reinforce~     developmentally appropriate self-management to help youth reach and maintain their best fetal~     hemoglobin (HbF) levels. However, this strategy alone may be insufficient to achieve daily HU~     adherence. The investigators therefore propose a feasibility trial to test the feasibility~     and acceptability of a structured intervention of CHW support to address existing barriers to~     improve HU use, augmented by daily cue-based parent and youth text message reminders, to~     efficiently extend CHW family support and reinforce family partnerships for self-management.~   "
117485|NCT02029729|"~     This proposed first-in-human study (408-C-1303) is designed to assess the safety, maximum~     tolerated dose, pharmacodynamics, and pharmacokinetics of omaveloxolone (RTA 408) in patients~     with advanced solid tumors that are refractory after standard of care therapy for the~     disease. The results of this study will help provide clinical information for the design and~     conduct of further clinical studies with RTA 408 in cancer patients.~   "
117486|NCT02029716|"~     This study is a first-in-human study of a topical dermal lotion formulation of RTA 408, a~     novel small molecule which suppresses oxidative stress and inflammation. In this study, the~     safety, local pharmacodynamics (PD), and systemic pharmacokinetics (PK) of RTA 408 will be~     evaluated following topical application of RTA 408 Lotion to healthy volunteers. This study~     will be conducted in three parts. In Part A of the study, healthy volunteers will have RTA~     408 Lotion Vehicle and RTA 408 Lotion (0.5%, 1%, and 3%) applied to a small skin surface area~     (four individual 4-cm2 sites; 16 cm2 total area) twice daily for 14 days to assess the local~     skin tolerability, local PD, and systemic PK of these treatments. Part B will be conducted~     after completion of Part A and will assess the safety, tolerability, local PD, and systemic~     PK of RTA 408 Lotion applied topically twice daily for 14 days to a larger skin surface area~     (~100 cm2). Part C will be conducted after completion of Part B and will assess the safety,~     tolerability, local PD, and systemic PK of RTA 408 Lotion applied topically twice daily for~     28 days to a larger skin surface area (~500 cm2). The maximum tolerated drug concentration in~     Part A will be used in Part B and Part C.~      Approximately 32 healthy adult volunteers will be enrolled in this study with 12 volunteers~     in Part A and 10 volunteers each, in Parts B and C.~   "
117487|NCT02029703|"~     The study hypothesis is that the use of Synvisc-One will improve physical therapy compliance~     and performance, resulting in improved knee function and pain when compared to a group that~     receives a sham injection (an injection that does not have medicine) only before a~     standardized physical therapy regimen over 10 weeks.~   "
117488|NCT02029690|"~     A study of ADI-PEG 20 (pegylated arginine deiminase), an arginine degrading enzyme in~     patients with histologically proven advanced malignant pleural mesothelioma (MPM), advanced~     peritoneal mesothelioma (in dose escalation cohort only), non-squamous non-small cell lung~     carcinoma stage IIIB/IV (NSCLC), metastatic uveal melanoma, hepatocellular carcinoma (HCC),~     glioma and sarcomatoid cancers~   "
117489|NCT02029677|"~     The purpose of this research study is to determine how changes in levels of obesity-related~     hormones in the gastrointestinal tract following Laparoscopic Adjustable Gastric Banding~     (LAGB) surgery may lead to a decrease in appetite and weight loss. Learning exactly how the~     Lap Band works may help us to develop new, less invasive treatments for morbid obesity. This~     knowledge may also lead to the development of preventive, cost-effective treatment~     strategies. As a control subject, participants will provide a comparison for changes in these~     hormones with medical weight loss compared to weight loss after LAGB surgery.~   "
117490|NCT02029664|"~     The purpose of this study is to determine the possibility of gait pattern change via visual~     feedback among patients with stroke. Also, the optimal visual feedback would be chosen from~     this study.~   "
117491|NCT02029651|"~     The purpose of this study is to determine whether novel upper extremity rehabilitation system~     for patients with stroke(e-glove system) are effective in the rehabilitation compared to~     conventional occupational therapy~   "
117492|NCT02029638|"~     The purpose of this study is to find out if the study treatment will allow people to accept~     their new kidney and be able to stop taking anti-rejection medications.~   "
117493|NCT02029625|"~     The purpose of this study is to compare the pharmacokinetics of NVP-1205 and coadministration~     of rosuvastatin and ezetimibe.~   "
117494|NCT02029612|"~     The goal of this research study is to compare 2 different phone-based programs for quitting~     smoking for people with HIV/AIDS.~   "
117495|NCT02029599|"~     The aim of this study is to evaluate the efficacy and safety of Fang yi qing Feng shi~     granules in subjects with Rheumatoid Arthritis.~   "
117496|NCT02029586|"~     This is a controlled study to determine the effectiveness and safety of MB12066 in the~     treatment of adult patients with Nonalcoholic Fatty Liver Disease(NAFLD) except cirrhosis.~   "
117497|NCT02029573|"~     The purpose of this study is to explore the efficacy and safety of Atorvastatin in~     combination with multimodality therapy of concurrent radiotherapy plus temozolomide followed~     by adjuvant temozolomide in patients with newly diagnosed glioblastoma multiforme (GBM).The~     anticipated time on study treatment is until disease progression, and the target sample size~     is 32 individuals.~   "
117498|NCT02029560|"~     To evaluate effect on cardiovascular system(blood pressure) when Thrupas® capsule is~     administered every day for 12 weeks in patients with Lower Urinary Tract Symptoms suggestive~     of Benign Prostatic Hyperplasia~   "
117499|NCT02029547|"~     This study is designed to validate the Japanese electronic florbetapir (18F) interpretation~     training program intended for post-approval implementation in Japan.~   "
117500|NCT02029534|"~     This study will compare the effects of 20 mg of atorvastatin to 80 mg of atorvastatin for the~     prevention of atrial fibrillation after cardiothoracic surgery. The study hypothesis is that~     80 mg of atorvastatin will be more effective at preventing atrial fibrillation compared to 20~     mg.~   "
117501|NCT02029521|"~     Many individuals with cystic fibrosis experience growth failure. The reasons are not clear,~     but inflammation of the gut in these patients seems to be one important reason. Glutathione~     is important to normal function of the intestine and lungs. Glutathione functions to decrease~     inflammation and to thin mucus. However, in cystic fibrosis, glutathione gets trapped inside~     of cells, so it cannot travel to the surface of the cells and perform its proper function.~     Moreover, glutathione has been shown to improve nutritional status in patients with AIDS and~     cancer.~      Investigators hypothesize that supplementation of oral glutathione to pediatric individuals~     with cystic fibrosis could improve growth failure.~   "
117502|NCT02029508|"~     The purpose of this study was to compare the treatment effectiveness of three different~     methods for posterior semicircular canal benign paroxysmal positional vertigo. The included~     methods are Modified Epley maneuver, Semont maneuver and Sham maneuver.~   "
117503|NCT02029495|"~     The primary objective of this study is to evaluate the efficacy of brodalumab, compared to~     placebo, in subjects with psoriatic arthritis.~   "
117504|NCT02029482|"~     This was a single-center, randomized, double-blind, placebo-controlled, up-titration Phase 1~     study. Sixteen subjects in two groups (at least 40% of subjects of either male or female~     sex), with 12 subjects in the active treatment group with an up-titration scheme from 10 to~     100 mg, and 4 subjects in the placebo treatment group. Subjects were administered ascending~     doses of ACT-128800/placebo once daily for 3 days at each dose level: 10 mg, 20 mg, 40 mg, 60~     mg, 80 mg, and 100 mg.~   "
117505|NCT02029469|"~     It is a non-randomized, consecutive enrollment, 10-year follow-up study of patients who are~     treated with the Ascension® HRA. Its purpose is to measure and document the outcomes~     associated with implanting the Ascension HRA prosthesis. Patients will be periodically~     assessed to collect data related to safety and effectiveness endpoints at the following~     intervals: preoperative, surgery/immediate post-op, 3 months, 6 months, 1 year, 2 year, 5~     year, and 10 years.~   "
117506|NCT02029456|"~     The aim of the present study was to assess the effects of low-dose (25mg) prolonged~     administration (in 6 hours) of tissue type plasminogen activator (tPA) on in-hospital~     mortality and outcomes in patients with massive PE.~   "
117507|NCT02029443|"~     This study is evaluating the safety and efficacy of a new Bruton tyrosine kinase (Btk)~     inhibitor, acalabrutinib, for the treatment of chronic lymphocytic leukemia (CLL)/small~     lymphocytic lymphoma (SLL)~   "
117508|NCT02029430|"~     This is a pilot study to determine the efficacy, kinetics and safety of aldoxorubicin in HIV~     positive subjects with Kaposi's sarcoma.~   "
117509|NCT02029417|"~     This phase II trial studies the side effects and how well omacetaxine mepesuccinate,~     cytarabine, and decitabine work in treating older patients with newly diagnosed acute myeloid~     leukemia. Omacetaxine mepesuccinate, cytarabine, and decitabine may stop the growth of cancer~     cells by blocking some of the enzymes needed for cell growth.~   "
117510|NCT02029404|"~     We will enroll patients submitted to feet elective orthopaedic surgery that require analgesia~     through continuous peripheral nerve block (CNPB) of the sciatic nerve. All catheters will be~     placed by anaesthesiologists experienced in ultrasound in prone positioning. The patients~     will be randomized in two groups with technique of sealed envelopes.~      In the tibial -peroneal nerve (TPN) group we will position the catheter within the confluence~     of peroneal and tibial nerve.~      In the tibial nerve (TN) group we will proceed , previous local anaesthesia, to insert a~     catheter medially to tibial branch of the sciatic nerve according to in plane approach.~      We will analyze A: the difference in consumption of local anesthetic in the two different~     groups B: the difference of insensate limb in the post-operative home as described by~     Ilfeld(inability to perceive the sense of touch throughout the area of distribution of the~     sciatic nerve) C: rate of foot drop D: numeric rate scale (NRS) for pain assessment, rate of~     dislodgment of the catheters, patient satisfaction, need for intervention by the~     anesthesiologist after discharge.~   "
117511|NCT02029391|"~     Musculoskeletal dysfunction is considered as a major public health problem affecting about~     one third of the adult population. Myofascial pain syndrome (MPS) characterized by myofacial~     trigger points as well as fascia tenderness are thought to be the main cause of~     musculoskeletal dysfunction. The aim of the treatment for musculoskeletal dysfunction is to~     reduce pain and restore normal function. Clinically, some evidence supports the application~     of kinesio tape in these patients. The underlying mechanism, however, is not clear. The~     investigators goal was to validate proposed mechanism of kinesio tape in these patients. The~     primary outcome are muscle stiffness, pain intensity and sensitivity.~   "
117512|NCT02029378|"~     Guillian-Barre Syndrome (GBS) is the most frequent cause of acute neuromuscular weakness in~     the Western World and can occur at any age. GBS is a rpadily progressive 'inflammatory'~     disorder of the perihperal nerves often leading to sever paresis of the limbs. Most GBS~     patients also have sensory disturbances (tingling or dull feeling) and pain. Some patients~     also have double vision or problems with swallowing. GBS mau also involve the respiratory~     muscles, leading to insufficient ventilation and admission to an intensive care unit. GBS~     pateints have a vairable prognosis; 20-30% require mechnical ventilation for a period ranging~     from weeks to months, 20% are unable to walk after 6 months nad 3-5% dies. Progression of~     weakness in GBS is usually rapid and reaches its peak within 4 weeks in the majority of~     patients, but many develop their maximum deficit within 2 weeks. Thereafter, the patients~     have a variable prognosis.~      GBS is a treatable disorder. Intravenous immunoglobulin (IVIg) 2g/kg administered in 5 days~     was shown to be effective when administered within the first two weeks after onset of~     symptoms, and is considered the treatment of choice by most experts in the field. Although~     the standard treatment for GBS is a single course of IVIg (2g/kg administered in 5 days),~     many patients fails to recover abd remain with substantial disability. Patients with GBS and~     especially those with a poor prognosis potentially may benefit from more powerful abd when~     possible a more mechanistically rational therapy.~      Recent experimental evidence suggests that complement activation palys a crucial role in the~     development of neuromuscular weakness in GBS making complement inhibitors and regulators~     attracive therapeutic targets. Our hypothesis is that Eculizumab, with its function as a~     complement inhibitor, will be very effective in preventing progression of weakness in~     patients with GBS.~   "
117513|NCT02029365|"~     In France , 15% of couples seek help for problems conceiving . In 10% of cases, infertility~     remains  unexplained . Among the causes of female infertility , there are the eating~     disorders, as well as sexual disorders , these two cases may be linked. In addition, data~     from the literature seem to suggest that beyond a diagnosis of eating disorders, the feeding~     behavior of infertile women is more often disturbed than the general population. Moreover,~     the notions of desire for a child and maternal representations seem essential to address in~     the comprehensive care of women with infertility but also TCA integrating all conflicting~     issues reactivated at the time of motherhood. However, little work has been done on this~     subject. Thus, we propose a study on the desire for children and the eating disorders to~     infertile women, to update epidemiological data, but also to better characterize this~     particular patient population. Perspectives of this work are to improve screening measures~     and support through a joint work of doctors reproductive and psychiatrists.~   "
117514|NCT02029352|"~     Basal cell carcinoma (BCC) is the most frequently occurring nonmelanoma skin cancer in~     Caucasians, representing approximately 80% of cases. Incidence rates for men and women in the~     Netherlands are 165 and 157 per 100,000 person-years respectively and are still rising 3-10%~     annually. In 2009, the lifetime risk for developing a first histologically confirmed BCC for~     men was approximately 1 in 5 (21%) and for women it was 1 in 6 (18%).~      A simplified classification of BCC includes the following three histological subtypes:~     nodular (40,6), superficial (30,7%) and infiltrative BCC (28,7%). Superficial BCCs (sBCCs)~     differ from the other subtypes as they tend to appear at a younger age, usually occur on the~     trunk and are often multiple. This subtype has the fastest growing incidence.~      A characteristic feature of BCCs is their low risk to metastasize, though if untreated they~     may induce considerable functional and cosmetic morbidity as they are locally invasive.~     Surgery is the first treatment of choice for BCC. However due to the rising incidence and the~     extensive workload this entails, a non-invasive topical treatment is often chosen for sBCC as~     they grow down from the epidermis into the superficial dermis and therefore are easily~     accessible for topical treatment. Photodynamic therapy (PDT), imiquimod cream or~     5-fluorouracil cream are available topical treatments for sBCC however their tumour free~     survival rates are not equal to the higher tumour free survival rates of surgical treatment.~     Next to the efficacy, the now available topical treatments are associated with local skin~     reactions at the treatment site, mainly erythema and erosion (imiquimod cream and~     5-fluorouracil cream) or pain and burning sensation (PDT). This creates the need for~     additional or alternative non-invasive topical treatments.~      The active constituents of green tea are promising as they are supported to have~     anti-BCC-carcinogenesis effects by several epidemiological, cell culture and animal studies.~     The so-called polyphenols known as catechins are the active constituents of green tea and the~     catechin epigallocatechin-3-gallate (EGCG) is the major and most active catechin. EGCG is~     thought to have a cytotoxic effect on skin cancer cells and has the availability of~     inhibition of cell growth and induction of apoptosis. It is also suggested that EGCG plays a~     role in inactivation of β-catenin signalling, an important component of the WNT pathway.~      Sinecatechins 10% ointment (Veregen®) is a standardized extract of green tea leaves of the~     species Camellia sinensis, containing mainly green tea polyphenols, particularly catechins~     (more than 85%). The lead catechin in sinecatechins ointment is EGCG. It is approved by the~     US Food and Drug Administration (FDA) for genital warts in adults.~      There are no clinical trials on human subjects with topical EGCG on sBCC yet. With this trial~     we are the first to try to validate the anti-carcinogenic potentials of topical EGCG in~     humans with sBCC. We assess the effectiveness of sinecatechins 10% (Veregen®) versus placebo~     for the topical treatment of sBCCs.~   "
117515|NCT02029339|"~     The closed systems, such as conventional negative pressure wound therapy (NPWT), were usually~     avoided in infected or critical colonized wounds. To our observation, the additional~     continuous irrigation tube attached beside the suction tube in the NPWT system could provide~     the effective drainage by reducing the occlusion of suction tube, enable effective~     debridement by diluting infected/necrotized tissues and decrease the incidence of fistula by~     providing relatively moist ambient. At our institutions, the modified system combined with a~     triple-tube device to allow a continuous instillation became more active and efficient. The~     study is to investigate if a continuous triple-tube instillation and suction could improve~     the outcomes of acute severely infected open abdomen.~   "
117577|NCT02028533|"~     This is a pilot feasibility study assessing the tolerability of chronic administration of~     intranasal oxytocin to patients receiving methadone at an opioid replacement clinic who are~     actively using cocaine.~   "
119263|NCT02006485|"~     The purpose of this study is to evaluate the safety and effectiveness of Ublituximab in~     combination with TGR-1202, with or without ibrutinib or bendamustine, in patients with~     advanced hematologic malignancies~   "
117516|NCT02029326|"~     Prometheus's Onco dX assay platform provides technological breakthrough for immunoassay by~     obtaining a level of sensitivity down to single tumor cells without compromising specificity.~     This allows assessment of multiple TKI treatment targets, their activation status, as well as~     down stream signaling proteins using very tiny amount of tissue that can be obtained by FNA~     or CTCs.~      We planned this study to explore biomarkers predictive of clinical response to~     cetuximab-based treatment in metastatic colorectal cancer using the Prometheus Platform. We~     will also elucidate signal transduction pathway attributable to cetuximab resistance, monitor~     changes in the RTK activation status during cetuximab treatment using circulating tumor cells~     and analyze correlation between the quantity of circulating tumor cells and treatment~     response to cetuximab.~   "
117517|NCT02029313|"~     The Purpose of A center, Randomized, Open label, single dose, Placebo-controlled,~     2-Treatment, 2-Way, 2-Period Crossover Study to Compare the Safety and the Pharmacokinetic~     Characteristics of MKT-N2 (Montelukast) and Singulair® (montelukast sodium) tablet 10mg in~     Healthy Male Korean Subjects~   "
117518|NCT02029300|"~     There are two routes in which a fiberoptic intubation can be performed - oral and nasal. In~     general, nasal intubation by any conventional method may be the preferred choice for certain~     procedures such as intra-oral surgeries, or for anatomical reasons such as limited mouth~     opening. If nasal intubation is not indicated or preferred, then oral intubation is usually~     performed.~      This study is looking to explore whether or not the nasal route significantly improves the~     ease and time for successful fiberoptic intubation compared to the oral route in children~     less than or equal to 2 years of age. This study will also examine if operator experience~     influence time to tracheal intubation with either route?~      The investigators hypothesize that the nasal route of fiberoptic intubation will be faster~     than the oral route, for both the trainee and the expert, and that there will be minimal~     differences between experts and trainees with nasal fiberoptic intubation.~   "
117519|NCT02029287|"~     The purpose of this study is to determine whether the Hospital-Community-Family-Care~     Management Platform for Chronic Heart Failure reduces the mortality, readmission rates and~     costs of the subjects with CHF.~   "
117520|NCT02029274|"~     This study investigates the dose response relationship for the efficacy and safety of BAF312~     compared to placebo in active DM patients over a treatment period of 6+6 months and to~     determine the minimum dose required for a maximal clinical effect. The study is composed of 2~     periods: a double-blind period I with BAF312 administered at different daily doses (0.5, 2,~     10 mg and placebo) and a fixed-dose Period II in which BAF312 will be administered at the~     dose of 2 mg daily .~   "
117521|NCT02029261|"~     The purpose of this study is to examine important and significant problems, that of insulin~     resistance and muscle wasting after burn injury.~   "
117522|NCT02029248|"~     Anorectal malformations, occurring approximately 1 in 5000 live births, mainly involve the~     distal anus and rectum, but also sometimes the urinary and genital tracts. Defects range from~     the minor and easily treated with an excellent functional prognosis, to those that are~     complex and often associated with a poor functional prognosis.~      Despite the better knowledge of the anatomy and physiology and the improvement of surgical~     management after birth, fecal and urinary incontinence can occur, due mainly to deficient~     nerve supply.~      The quality of life of such patients is largely unknown in this country. The aim of the~     investigators study is to propose specific and generic questionnaires to the patients~     registered in the national database, correlated to their anatomical and functional status. A~     better understanding of such correlations should allow improvements in their medical and~     social management.~   "
117523|NCT02029235|"~     The purpose of this research study is to find out which combination of pain medications~     following surgery work the best and result in the fewest side effects.~   "
117524|NCT02029222|"~     Patients with lung cancer may develop a second primary tumor or recurrent disease after~     previous radiotherapy. Surgical salvage therapy is the mainstay of therapeutic options.~     However, in case of irresectable disease, re-irradiation should be considered. Also in the~     postoperative setting, re-irradiation is considered after surgical salvage in case of~     features in the pathology specimen indicating a high risk for subsequent recurrence. However~     after re-irradiation, there is a high risk of 43% grade 3 (late) toxicity at 5 years~     (including possible fatal complications) and a relatively low chance of locoregional control~     of 50% at 5 years. One out of three patients survives re-irradiation without recurrence and~     severe complications. Improvements in both the risk of radiation-induced complications and~     the oncological outcome are thus warranted.~      Compared to conventional radiotherapy with photons (CRT), particle therapy (PT) has the~     potential to inflict maximum damage on tumors with minimum collateral damage to neighboring~     healthy tissue. Given that the cost of particle therapy (PT) is considerably higher than that~     of conventional radiotherapy (RT) with photons, it is necessary to establish whether these~     higher costs are worthwhile in light of the expected advantages. Thus, clear evidence of the~     situations in which PT outperforms conventional photon treatment is needed. Publications on~     this topic are rare. The only recent publication has analyzed the results of 37 NSCLC~     patients of whom 9 were re-irradiated with at least 50 Gy using helical tomotherapy [Kruser~     in press].~      We propose an in silico trial to investigate to what extend proton and 12C-ion therapy~     decrease the amount of irradiated normal tissue in lung cancer patients treated with~     radiotherapy after an initial radiotherapy treatment.~   "
117525|NCT02029209|"~     1. To reveal changes of peripheral markers and blood perfusion parameters in vivo tumor in~          the phase II study of anlotinib in patients with advanced non-small cell lung cancer.~        2. To clarify the meaning of peripheral markers and blood perfusion parameters in vivo~          tumor in predicting the effect of anti-angiogenic therapy.~   "
117526|NCT02029196|"~     Electronic Vapour Products (EVPs) is a relatively new class of consumer products that are~     otherwise known as electronic cigarettes or electronic nicotine delivery devices/systems.~     These may look like conventional cigarettes but do not contain tobacco.~      The 'vapour' produced by such devices typically consists of humectants (propylene glycol or~     glycerol), nicotine, water, and flavours.~      This trial is to evaluate the safety of an e-vapour product.~   "
117527|NCT02029183|"~     Ischemic stroke is a kind of common disease with great harm. In acute stage of stroke there~     is sharply increasing morbidity of sleep apnea hypopnea syndrome. Our suppose that treatment~     with noninvasive ventilation for patients with acute ischemic stroke should improve the~     functional prognosis（measuring with 90d modified Rankin score）.~   "
117528|NCT02029170|"~     Unstable ankle fractures are commonly treated operatively. After operative reduction and~     fixation of the fractures, there are varying rehabilitation regimes that include~     non-weightbearing for 6 weeks with active range of motion exercise in a removal cast or~     brace, or early protected weightbearing in a rigid cast. Several papers reported that early~     weightbearing may decrease ankle stiffness, muscle and bone atrophy, and aids in early return~     to activities. However, early weightbearing may have the risk of displacement of the fixed~     fractures. Rehabilitation after operative treatment of an ankle fracture is still not clear.~     We hypothesized that the ankle function assessed on 12 months after operation of an ankle~     fracture with early weightbearing is not inferior to non-weightbearing but is superior to~     non-weightbearing with respect to time to return to normal daily life and time to full~     weightbearing.~   "
117529|NCT02029157|"~     The present clinical trial is aiming to evaluate efficacy of ARQ 197 in patients with~     hepatocellular carcinoma (HCC), who were resistant or intolerable to one systemic~     chemotherapy regimen including sorafenib.~   "
117530|NCT02029144|"~     Dydrogesterone has been widely used worldwide for various gynecological and obstetric~     indications:~        -  Dydrogesterone is effective in cycle regulation treatment.~        -  Dydrogesterone is recognized as none interference to hypothalamus pituitary ovary (HPO)~          axis in the recommended dosage.~        -  Dydrogesterone might have non-negative effect on glucose and lipid metabolic.~   "
117531|NCT02029131|"~     Evaluation of the effectiveness of an individually educated exercise program for the lower~     back at home in employees over a period of 20 weeks.~      We hypothesize that regular exercise for the lower back results in greater improvements of~     low back strengths compared to controls.~   "
117532|NCT02029118|"~     Hypothesis: acupoint application is effective for managing chronic stable angina pectoris.~     Aim: to evaluate the efficacy and safety of acupoint application on the specific acupoints~     for chronic stable angina pectoris. Design: A Randomized, Controlled,Double Blind trial. 200~     participants will be included. Four arms: herbal medicine application on acupoint group ,~     placebo application on acupoint group , herbal medicine application on non-acupoint group and~     placebo application on non-acupoint group.~   "
117533|NCT02029105|"~     In this study, the investigators analyzed the efficiencies of hyaluronan, osteopontin,~     C-ERC/mesothelin, N-ERC/mesothelin and syndecan-1 serum levels, both individually and in~     combination, in distinguishing malignant pleural mesothelioma patients from patients with~     metastatic malignant pleural diseases, benign pleural diseases, and benign asbestos pleurisy.~   "
117534|NCT02029092|"~     This registry is a clinical evaluation of the Orsiro LESS in subjects requiring coronary~     revascularization with Drug Eluting Stents (DES). It is designed to investigate and collect~     clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting Stent~     System in an all-comers patient population in daily clinical practice.~   "
117535|NCT02029079|"~     Malnutrition increases the risk of complications and predisposes ti infections through~     impaired immune response and wound healing. Healthcare costs related to the management of~     malnourished patients is estimated to be more than double the amount spent managing non-~     malnourished~      The objective of this study is to examine the effect of newly developed energy and~     nutrients-dense beverage product on the nutritional status among patients at risk of~     malnutrition.~   "
117536|NCT02029066|"~     This study is designed to evaluate the pharmacokinetics of solamargine of SR-T100 gel. As~     safety parameters, adverse events, and vital signs (blood pressure, heart rate, and body~     temperature) will be recorded.~   "
117537|NCT02029053|"~     This is a pilot study, assessing the ability and safety of the use of VR101 intravaginal ring~     to relieve the symptoms of vaginal dryness, in peri and post-menopausal women. VR1010 is~     designed to release glycerol. The study will assess the duration of lubrication/~     moisturization of the vagina with the VR101 intravaginal ring in place (up to 7 days) and~     participant satisfaction of the device.~      Study participants will insert the intravaginal ring and leave it in place for an initial 7~     days and then repeat this process a 2nd time. Participants will respond to questionnaires,~     complete a daily diary and come in for 4 separate study visits. Each study visit will involve~     a brief vaginal exam.~      Upon removal of the initially inserted device (7 days after first study visit), participants~     will insert a second device for an additional 7 days and undergo the same evaluation.~   "
117538|NCT02029040|"~     This is a randomized, double-blind, controlled trial in the Pediatric Emergency Department.~     The primary objective is to determine whether nebulized 3% hypertonic saline is more~     effective than nebulized 0.9% saline in the treatment of bronchiolitis in the emergency~     department.~   "
117539|NCT02029027|"~     The aim of this study is to assess the benefit of GYNEFFIK®, a perineal electro-stimulator,~     during this home-care phase. Women with stress urinary incontinence (UI) or with mixed UI~     (composed predominantly of stress UI), that responded to physiotherapy were included in this~     study in two parallel groups. The groups followed a self-reeducation program, with or without~     GYNEFFIK® electro-stimulation sessions. The comparison of the two groups was based on the~     rate of women for whom the benefit of the initial perineal reeducation was maintained.~   "
117540|NCT02029014|"~     The aim of this study is to assess the efficacy, safety and performance of LAmbre left atrial~     appendage closure system in patients with non-valvular atrial fibrillation who cannot be~     treated with Warfarin.~   "
117541|NCT02029001|"~     MOST is a phase II trial conducted in adult patients with an advanced solid tumor in~     progression after at least 1 prior treatment regimen. The study aims to assess whether a~     12-week treatment with a targeted therapy selected based on the alteration(s) detected in the~     tumor is sufficient to stabilize the disease compared with a longer treatment, for all~     patients presenting this alteration, regardless of the primary disease site or cancer type.~     All the targeted therapies administered in MOST study already obtained a marketing~     authorization (MA) but will be evaluated in indications other than those defined in their MA.~      Each patient enrolled will receive the matching targeted therapy during 12 weeks (induction~     treatment). At the end of this period:~        -  patients with a tumor response will continue the targeted therapy,~        -  patients in progression will discontinue the targeted therapy and will be withdrawn from~          study and oriented towards standard treatments~        -  patients with a stable disease at 12 weeks will be randomized in order to determine if~          they continue or stop the targeted therapy.~      About 80 patients will be treated in each of the 5 treatment groups opened to enrollment,~     each group corresponding to an available targeted therapy.~   "
117542|NCT02028988|"~     This research study is evaluating a drug called enzalutamide in combination with external~     beam radiation therapy as a possible treatment for prostate cancer. Presently, when~     participants receive hormonal therapy with radiation therapy for prostate cancer, medications~     are given to reduce testosterone levels in the blood stream. This leads to side effects such~     as loss of sex drive, erectile dysfunction (ED) and decrease in muscle strength. The purpose~     of this study is test another form of hormonal therapy with radiation therapy. The medication~     called enzalutamide will be used with radiation therapy. Instead of lowering testosterone,~     enzalutamide blocks testosterone in cells. This study will test if enzalutamide when used~     with radiation will lower the PSA without causing the side effects associated with~     medications that lower testosterone in the blood stream.~   "
117543|NCT02028975|"~     Animal studies have shown that stimulation of the lingual lipid-receptor, CD 36, is~     accompanied by the rapid secretion of hormones in the digestive tract (incretines). We aim to~     determine in healthy humans whether the orosensory perception of fatty acids is followed by a~     modification in plasma levels of digestive tract hormones (cholecystokinin, GIP, GLP-1,~     secretin, pancreatic peptide, peptide YY, insulin) and metabolic markers from adipose tissue~     (leptin, ghrelin, adiponectin).~      We also aim to determine whether the hormonal response induced by orosensory stimulation by~     lipids is modified:~        -  in patients with type 2 diabetes~        -  in obese non-diabetic patients We expect to show an increase in biological markers~          biological, and more particularly in certain digestive hormones such as Pancreatic~          polypeptide, GIP, GLP-1…after stimulation of the lingual lipid receptor, CD36. We will~          also determine whether or not this response is modified in patients with type 2 diabetes~          and in obese non-diabetic patients.~      We also wish to measure the subjects' gustatory detection threshold for a fatty acid~     (linoleic acid), and to determine whether there is a relationship between the orosensory~     perception threshold for linoleic acid and the physiological status of the subjects. In order~     to achieve this, the thresholds for healthy subjects will be compared with thresholds for~     obese and diabetic subjects. Expected results: the threshold of detection for linoleic acid~     in healthy subjects will be lower than that in obese or diabetic patients.~   "
117544|NCT02028962|"~     The research aim is the development, implementation and evaluation of the first computer~     tailored smoking cessation progam for Romanian adult smokers. It will be implemented among~     smokers from Romania aged 20-60 years. The participants will beneficiate of tailored~     information received in letters generated by using sophisticated computer algorithms,~     allowing the creation of highly individualized messages that address each individual's unique~     needs, motivations and beliefs related to smoking .~      Program implementation will comprise of :~        1. ''diagnosis'' by means of questionnaires at the individual level of characteristics that~          are relevant for a person's smoking behavior~        2. development of the ''message library'' that contains all education messages that may be~          needed~        3. development of an ''algorithm'', a set of decision rules that evaluates the diagnosis,~          selects and generates messages tailored to the specific needs of the individual user~        4. generating of personalized letters for each participant~        5. sending of theses personalized letters to the participants. The participants will~          receive three personalized letters during a period of six months after registration into~          the program.~      The effects of the program will be evaluated with a randomized controlled trial which will~     assess the changes in smoking behaviour as well as smoking related attitudes, self-efficacy~     and quiting attempts at 6 months after the enrolment into the program.~      A process evaluation will assess participants' opinion about the program.~   "
117545|NCT02028949|"~     Unresectable, non-metastatic cirrhosis-related hepatocellular carcinoma (HCC) has a poor~     prognosis as there are no recommended curative treatments. Chemoembolisation is the most~     widely used treatment in these patients, but this technique can prove to be toxic.~     intrahepatic arterial chemotherapy with lipiodol and idarubicin could be an effective~     therapeutic approach, without deteriorating liver function.~      The rationale for this treatment can be resumed as follows:~        -  HCC are vascularised via the hepatic artery system~        -  The IHA perfusion of anthracyclines leads to high elimination via the liver with low~          systemic concentrations~        -  The absence of embolisation reduces toxicity~        -  the toxiciity profile of idarubicin is well known and the drug is widely used for the IV~          treatment of leukemia~        -  idarubicin is the most cytotoxic drug for tumor cell lines.~        -  The in vitro cytotoxicity of idarubicin is 100% at low concentrations~        -  Lipiodol can stay in contact with tumor tissue for several weeks after injection and act~          as a vector for the drug~        -  The idarubicin-lipiodol is more stable than lipidol emulsions usually given by~          intraarterial injection~        -  The emulsion is more stable with idarubicin than with other anticancer molecules~        -  Sequential inclusion in accordance with the continual reassessment method makes it~          possible to increase inclusions at a target toxicity level while reducing inclusions at~          doses that are too low or too toxic The aim of the treatment is to improve survival.~   "
117546|NCT02028936|"~     Many epidemiological and clinical studies have suggested the negative effect of oxidative~     stress ( = attack of cell components by free radicals) on the cardiovascular risk, notably in~     patients with metabolic syndrome, insulin resistance, diabetes or obesity and smokers.~      Polyphenols, notably those present in red grapes, have a certain antioxidant effect. Dietary~     supplementation with polyphenols in high-risk patients could diminish the harmful~     consequences of oxidative stress.~      The aim of this study is to show that the daily consumption of grape juice rich in~     polyphenols  R@isol , has a positive impact on the oxidation/antioxidation balance in~     healthy volunteers.~   "
117547|NCT02028923|"~     This phase III study aims to show that topical morphine low doses treats localized pain in~     chronic wounds, intense and rebellious to systemic analgesics included or not opioids.~   "
117613|NCT02028052|"~     The objective of this study is comparing the attributable procedural time of Endobronchial~     Ultrasound - Transbronchial Needle Aspiration (EBUS-TBNA) when sampling mediastinal and hilar~     lymph nodes with or without Rapid On-Site Evaluation (ROSE). The primary outcome will be the~     time elapsed from EBUS bronchoscope insertion to bronchoscope withdrawal. Secondary outcomes~     will include total number of sampled lymph nodes, average number of needle aspirations per~     lymph node sampled, overall diagnostic yield, and procedural time of the cytopathologist.~   "
117614|NCT02028039|"~     The goal of this clinical research study is to learn if IPI-145 can help to control the~     disease in patients with ALL. The safety of the study drug will also be studied.~   "
117548|NCT02028910|"~     Acute gastroenteritis is a common disease especially in children. With bronchiolitis and~     influenza, she participated widely in weight of winter epidemics that causes problems every~     year our health care system, particularly in the pediatric emergency and inpatient since they~     are the second leading cause of hospitalization in children. The main symptoms of viral acute~     gastroenteritis are diarrhea and vomiting which exposes children to the risk of sometimes~     severe dehydration, the most common cause of hospitalization. There is no specific treatment~     for these infections. At most, there is a vaccine against severe rotavirus diarrhea (Rotarix~     ® and RotaTeq ®), but does not yet official recommendations to use in France. The treatment~     of acute gastroenteritis virus is symptomatic and is generally based on the use of oral~     rehydration solutions (ORS) whose administration is limited by the frequent presence of~     vomiting. Until now, no treatment has demonstrated its effectiveness on vomiting due to acute~     gastroenteritis virus in children. Conventional anti-emetics, widely prescribed, are~     ineffective in practice, very few studies in this indication and encumbered side effects.~     Several drugs have long been used in children to fight against severe vomiting associated~     with the administration of anti-cancer chemotherapy, such as granisetron (Kytril ®) and~     ondansetron (Zofren ®). The mechanism of action of these molecules is well known. They act~     both on the enteric nervous system by blocking serotonin receptors. Several~     placebo-controlled trials suggest that ondansetron is effective in reducing the number of~     vomiting in children emergency consultant for acute gastroenteritis. However, the method used~     in these tests and the number of children enrolled has not yet demonstrated the efficacy of~     ondansetron on the number of admissions, the number of emergency and return the cost /~     benefit ratio of this treatment. In addition, several studies reported the occurrence of~     watery stools more frequently in children treated with the placebo group.~      Evidence that ondansetron is well tolerated and effective for reducing the severity of~     vomiting during acute gastroenteritis pediatrics winter could support the use of this~     treatment in routine pediatric emergencies.~      This study is a clinical trial, multicenter, controlled versus placebo whose main objective~     is to evaluate the efficacy of ondansetron to decrease the intensity of vomiting in children~     with acute gastroenteritis during winter emergencies Upon arrival to the emergency room after~     signing. Consent, an ECG is performed in eligible patients. Children meet all the criteria~     for inclusion and non-inclusion receive, at random, one of two treatments: ondansetron~     (active) or placebo. The study does not alter the usual care of the child to the emergency~     room. After passing emergency, patients will be followed in the study for 8 days, through a~     phone call home to J3 and J7. The total duration of patient participation in the study is 8~     days, including 4 hours emergencies (usual transit time to emergencies).~   "
117549|NCT02028897|"~     This study will compare two alternative embryo culture systems. Embryos from each patient~     will be randomly assigned to one of two systems. One group will be cultured conventionally in~     oil-covered droplets in dishes. The other group will be assigned to an enclosed system.~   "
117550|NCT02028884|"~     The objective of this study is to evaluate the efficacy, safety, pharmacodynamic,~     pharmacokinetic and immunogenic profiles of SA237 in patients with NMO and NMOSD~   "
117551|NCT02028871|"~     This FDA-approved (IND# 120700) study will evaluate efficacy of intranasal insulin in~     reducing snack intake and reducing postprandial free fatty acid levels in abstinent smokers.~   "
117552|NCT02028858|"~     This is a prospective, observational study designed to describe the effects of Cannabis on~     Parkinson's Disease tremor.~   "
117553|NCT02028845|"~     1. Background~             -  Advanced guidewires with a U-shaped tip could effectively cross the long or~               multi-occlusive segment smoothly and go into the distal outflow vessel.~             -  The guidewire looping technique is a safe and effective method for the~               recanalization of the occluded lesions in infrapopliteal vessels.~        2. Objective - To compare the performance a loop-tipped guidewire with a straight-tipped~          guidewire in achieving successful deep biliary cannulation.~        3. Design~           - Prospective randomized trial.~        4. Setting:~           - Tertiary-care medical center~        5. Patients~           - This study will involve 192 patients with biliary diseases which require endoscopic~          retrograde cholangiopancreatography.~        6. Intervention - Cannulation of bile duct by using a loop-tipped guidewire or a~          straight-tipped guidewire~        7. Main outcome measurements - Compare the cannulation success rate, the duration of the~          cannulation, immediate and late complications.~   "
117554|NCT02028832|"~     This study will investigate if adding complementary therapies such as acupuncture, massage~     and reiki to inpatient pediatric care is feasible and what the effects are on outcomes such~     as patient symptoms, cost, safety, satisfaction and length of stay.~   "
117555|NCT02028819|"~     Ibalizumab is a humanized immunoglobulin G monoclonal antibody directed against a human~     T-cell receptor (CD4) and thus suppresses HIV replication by blocking entry of HIV into CD4+~     lymphocytes. Ibalizumab has completed phase I and II clinical studies in HIV-negative and~     HIV-infected individuals showing safety and efficacy for suppressing HIV replication.~   "
117556|NCT02028806|"~     This phase Ⅱ study was designed to evaluate the efficacy and safety of mFOLFIRINOX as~     first-line treatment for metastatic pancreatic cancer in China.~   "
117557|NCT02028793|"~     National Health Insurance Administration, Taiwan has provided a protocol for community~     pharmacist to offer home pharmaceutical care for the patients with high health expenditures.~     Since community pharmacists need to visit patients for consultation and check their~     medications, it has been thought to have pressure for them in various areas. This study~     intends to investigate the factors related to the pressure and intention for leaving this~     protocol. The hypothesis are that community pharmacist who works longer, has economic~     pressure, and longer year of practice will have higher pressure and strong intention for~     leaving.~   "
117558|NCT02028780|"~     The primary objective is to investigate the safety, tolerability and pharmacokinetics of BI~     655075 following intravenous administration of single rising doses of BI 655075 when~     administered alone and after administration of dabigatran.~   "
117559|NCT02028767|"~     The trial is being conducted to establish the bioequivalence of emp/met (12.5mg/500mg) fixed~     dose combination tablets compared to tablets administered together in healthy male and female~     volunteers under fed conditions.~   "
117560|NCT02028754|"~     This study will evaluate the effect of sodium carboxymethylcellulose eye drops in the~     treatment of dry eye after cataract surgery.~   "
117561|NCT02028741|"~     The purpose of this study was to explore the immediate effects of transversrse vertebral~     pressures (TVP) to the thoracic spine on cervical range of motion and pain in subjects with~     neck pain,~   "
117562|NCT02028728|"~     Clinical evaluation of the Orsiro LESS in subjects requiring coronary revascularization with~     Drug Eluting Stents (DES). 500 subjects will be enrolled in this registry. The sample size~     maybe increased in order to reach the subgroup sizes (Diabetes, small vessel, AMI and CTO).~   "
117615|NCT02028026|"~     The purpose of this study is to determine whether vilazodone is more effective than~     citalopram for the treatment of anxious depression. We will use neuroimaging to see whether~     there are changes in the brains of patients receiving the drug vilazodone that are different~     from those of citalopram. These changes may show that vilazodone affects the brain~     differently than most other kinds of standard antidepressant medications.~   "
126980|NCT01905384|"~     The purpose of this study is to compare the rate of long-term stent failure, defined as need~     for repeat biliary intervention following placement of C-SEMS vs U-SEMS for palliation of~     inoperable malignant distal bile duct obstruction.~   "
117563|NCT02028715|"~     The investigators' goal in this planned prospective, randomized, patient blinded study is to~     compare our standard of care as the control group to an experimental group in which patients~     receive preemptive IV acetaminophen dosing that is continued every 6 hours for a total of 8~     doses in patients who have undergone major gynecologic surgery. The outcomes analyzed will~     include amount of rescue opioids required, time to return of bowel function, length of~     hospital stay, cost effectiveness, and patient satisfaction. The hypothesis is that the~     addition of IV acetaminophen will decrease the need for opioid rescue and thereby decrease~     the incidence of associated gastrointestinal side effects including nausea, vomiting,~     bloating, and constipation. The hope is that it will affect the final outcome of quicker~     return of bowel function, increased patient satisfaction, shortened hospital stay and prove~     to be an overall more cost effective postoperative pain management approach.~   "
117564|NCT02028702|"~     To investigate the reported health benefits (lipid profile, inflammatory factors,~     cardiovascular status and bone density) of a novel, phytoestrogen rich, Red Clover treatment~     on women suffering from both menopause related primary (hot flushes, night sweats, sleep~     disturbance and weight gain) and secondary (osteoporosis, cardiovascular and changes in lipid~     metabolism) symptoms.~   "
117565|NCT02028689|"~     This study will assess the potential effects of lesinurad on the pharmacokinetics (PK) of~     metformin and furosemide in healthy, adult male subjects.~   "
117566|NCT02028676|"~     The two original objectives were to determine in HIV-infected children initiating~     antiretroviral therapy (ART):~        1. Whether clinically driven monitoring (CDM) will have a similar outcome in terms of~          disease progression or death as routine laboratory and clinical monitoring (LCM) for~          toxicity (haematology/biochemistry) and efficacy (CD4)?~        2. Whether induction with four drugs from two ART classes followed by maintenance with~          three drugs after 36 weeks be more effective than a continuous non-nucleoside reverse~          transcriptase inhibitors (NNRTI)-based triple drug regimen in terms of CD4 and clinical~          outcome?~           Two secondary objectives were to determine~        3. Whether changing from twice daily lamivudine+abacavir to once daily lamivudine+abacavir~          after 48 weeks on ART will have a similar outcome in terms of virological suppression~          and will result in improvements in adherence to ART?~        4. Whether stopping daily cotrimoxazole prophylaxis in children over 3 years of age who~          have been on ART for at least 96 weeks has a similar outcome in terms of hospitalisation~          or death as continuing daily cotrimoxazole?~   "
117567|NCT02028663|"~     The purpose of this study is to investigate the optimal dose and administration methods of~     CJ-12420 in patients with erosive esophagitis by comparing the safety and efficacy of orally~     administered CJ-12420 to esomeprazole 40mg.~   "
117568|NCT02028650|"~     The relapse leukemia patients after transplantation were divided into two groups randomly.~     Group D1: patients received first-donor stem cells infusion(DSI) treatment with or without~     chemotherapy; group D2: patients received second-donor DSI treatment with or without~     chemotherapy. The second donors were preferably donors who were genetically related and had~     more HLA-match locus. The re-induction chemotherapy regimen was primarily MAT(mitoxantrone,~     cytarabine, Teniposide ) for acute myeloid leukemia (AML) and VMCLD(vincristine, Teniposide,~     cyclophosphamide, L-Asparaginase, Dexamethasone) for acute lymphocytic leukemia (ALL), and no~     graft versus host disease(GVHD) prevention was conducted pre- and post- therapy.~   "
117569|NCT02028637|"~     Introduction: Recently it has involved the role of TLR (toll-like receptors) in the~     pathogenesis of asthma. TLRs are a family of proteins responsible for the recognition of~     Pathogen-Associated Molecular Patters (PAMPs). The possible role that TLRs play in~     IgE-dependent asthma (not eosinophilic) and its recognition as a new endotype asthma, could~     open new therapeutic expectations.~      Objective: To analyze the expression of TLR 2 and 4 in monocytes/ macrophages and neutrophils~     in peripheral blood and induced sputum from asthmatic patients~   "
117570|NCT02028624|"~     Aim of the present study was to evaluate the effect of different lifestyle intervention~     administrations, in increasing adherence to the Mediterranean diet in a group of patients~     with RA living in the Mediterranean basin, and, thus, in improving parameters related to~     subjective and objective disease markers, including plasma adiponectin concentrations.~   "
117571|NCT02028611|"~     There were many studies which examined the availability of inverted gray-scale chest X-ray~     for increasing the detection of lung nodules. In emergency medicine, rib fracture is an~     important part for patient's disposition, so investigators designed this study to evaluate~     the availability of inverted gray-scale chest X-ray for the detection of rib fracture.~   "
117572|NCT02028598|"~     The purpose of this study is to evaluate the safety and pharmacokinetics/pharmacodynamics of~     co-administration of Clomipramine HCl 15mg and Sildenafil citrate 100mg compared to the~     effects after single oral administration in Korean healthy male volunteers.~   "
117573|NCT02028585|"~     This study aimed to investigate the effects of low-fat milk consumption on metabolic~     parameters and biomarkers related to inflammation, oxidative stress, and endothelial function~     in Korean adults with metabolic syndrome.~   "
117574|NCT02028572|"~     Glaucoma is an optic neuropathy characterised by progressive degeneration of retinal ganglion~     cells and axons that leads to nerve fibre loss, optic disc cupping, and consecutive~     glaucomatous visual field defects. It is considered to be one of the major causes of~     blindness worldwide.~      It is a well accepted fact least 25 - 40% of retinal ganglion cells need to be lost before~     statistically detectable visual field defects appear on automated visual field testing, which~     is also consistent with post-mortem histologic findings in glaucomatous eyes. Since the~     damage associated with glaucoma is irreversible, and retinal nerve fibre layer loss is~     considered as an early sign of glaucomatous damage, its early detection and prevention is~     warranted. Retinal nerve fibre layer studies can be undertaken through non - invasive,~     reproducible technologies such as optical coherence tomography, scanning laser polarimetry~     etc.~      The purpose of the study is to evaluate the relationship between visual fields and retinal~     nerve fibre layer thickness as measured by Cirrus spectral domain optical coherence~     tomography with visual fields by Humphrey Field Analyser (HFA) in early and moderate primary~     open - angle glaucoma.~   "
117575|NCT02028559|"~     A feasibility study to test the ability to move kidney stones using a modified ultrasound~     system. It is the goal of our technology to move the stone fragments to a location within the~     kidney to improve their chances of passage, and thus reduce the occurrence of additional~     symptomatic events and retreatment.~   "
117578|NCT02028507|"~     This is an international (4 countries) randomized phase III study with 2 cohorts, patients~     will be randomized 1:1 to endocrine therapy (cohort 1: exemestane 25 mg daily, cohort 2:~     fulvestrant 500mg days 1 and 15 cycle 1 and then day 1 every 4 weeks) plus palbociclib (125~     mg daily x3 weeks every 4 weeks) vs. capecitabine (1,250 mg/m2 twice daily x2 weeks every 3~     weeks). Postmenopausal patients with HR+/HER2 MBC are eligible if resistant to previous NSAI~     (letrozole or anastrozole) in cohort 1 or pevious AI (letrozole, anastrozole or exemestane)~     in cohort 2 defined as: recurrence while on or within 12 months after the end of adjuvant~     treatment with NSAI/AI or progression while on or within 1 month after the end of treatment~     with NSAI/AI for MBC. Previous chemotherapy is permitted either in the (neo)adjuvant setting~     and/or as first line for MBC. Patients must have measurable disease according to RECIST 1.1~     or bone lesions, lytic or mixed, in the absence of measurable disease.~   "
117579|NCT02028494|"~     The purpose of this study is to compare the efficacy of a novel schedule of an oral~     anticancer drug, capecitabine, in patients with metastatic breast cancer.~      Mathematical models have predicted that 7 days of capecitabine followed by 7 days of rest is~     an optimal dosing schedule for this drug and previous studies done al Memorial Sloan~     Kettering Cancer Center support the tolerability of this scheme.~      This definitive, randomized trial comparing the efficacy of the new dosage with the~     conventional dosing schedule in patients with metastatic breast cancer is necessary and we~     hypothesize it will be superior in terms of efficacy.~      Dosing schedules based on mathematical predictions for optimal drug delivery based on~     efficacy rather than toxicity could facilitate more rapid and economical drug development.~     This trial is a proof of principle trial of the highest priority.~   "
117580|NCT02028481|"~     Macular hole is a hole formation which takes place in the center of the retina. Such a hole~     needs surgical steps in order to close. Closure of the macular hole will lead to a~     substantially improvement of vision in most cases. Following macular hole surgery a tamponade~     of intraocular gas is normally injected in order to keep the macula dry for the postoperative~     period. Postoperative face down position for a week was earlier standard. Several authors~     report of good closure rates with both air tamponade or lack of face down positioning. In~     this study standard pars plana vitrectomy with peeling of the internal limiting membrane~     (ILM) will be performed. The gas tamponade will be replaced by air. Postoperative face down~     positioning will not be used. Only macular holes less than 400 μm will be included.~   "
117581|NCT02028468|"~     Hemiarthroplasty is a well established treatment of Femoral Neck Fractures in the Elderly.~     During the last decade the use of Minimal Invasive Surgical( MIS) approaches have been~     increasing. Our hypothesis is that Patients with a Femoral Neck Fracture may benefit from a~     MIS approach.~   "
117582|NCT02028455|"~     Patients with relapsed or refractory leukemia often develop resistance to chemotherapy. For~     this reason, we are attempting to use T cells obtained directly from the patient, which can~     be genetically modified to express a chimeric antigen receptor (CAR). The CAR enables the T~     cell to recognize and kill the leukemic cell through the recognition of CD19, a protein~     expressed of the surface of the leukemic cell in patients with CD19+ leukemia. This is a~     phase 1/2 study designed to determine the maximum tolerated dose of the CAR+ T cells as well~     as to determine the efficacy. The phase 1 cohort is restricted to those patients who have~     already had an allogeneic hematopoietic cell transplant (HCT). The phase 2 is open to all~     patients regardless of having a history of HCT.~   "
117583|NCT02028442|"~     This is a multicentre, open-label, Phase I/II study of enadenotucirev in patients with either~     solid tumour of epithelial origin not responding to standard therapy or for whom no standard~     treatment exists (Phase I dose escalation stage Single cycle), mCRC not responding to~     standard therapy (Phase I dose escalation Repeat cycle cohort expansion stage ), mCRC not~     responding to standard therapy or advanced or metastatic bladder cancer not candidate for~     chemotherapy (Phase Ib) or mCRC in stable disease or partial response after 3-4 months of~     first line standard of care chemotherapy (Phase II).~   "
117584|NCT02028429|"~     The study is being conducted to evaluate the efficacy of Sildenafil (a 5-phosphodiesterase~     inhibitor) as a means to improve the cognitive impairment encountered in patients of minimal~     hepatic encephalopathy (MHE) as proposed in different studies.~      This study would also assess the role of improvement of cognition as a means of improvement~     in quality of life.The patients will receive Sildenafil or no treatment for 4 weeks.~      This study may prove and provide important therapeutic strategy for cognition impairment in~     patients with MHE.~   "
117585|NCT02028416|"~     Acquired Aplastic anemia is one of the most frequent reason of bone marrow failure in East~     (Pakistan).~        -  The first treatment option is Allogenic Bone Marrow transplantation which is an~          expansive treatment option and also require a full matched HLA identical donor, hence~          hardly 25% of our affected patients get opportunity for BMT.~        -  The second line treatment option caters a large chunk of patients (severe and non-severe~          AA) along with those who lack HLA identical donor.~      Previously many protocols had been used in past for ATG+CsA Treatment, this treatment~     protocol especially addresses the two different regimens of ATG to study its efficacy,~     durability and long-term effects. Following doses would be used:~        -  CsA+ATG @ 10mg/kg for 3 days~        -  CsA+ATG @ 10mg/kg for 5 days~   "
117586|NCT02028403|"~     People infected with HIV may have low levels of the virus in their body, even if they are~     taking HIV medications. This study will evaluate the safety, pharmacokinetics (PK) (which is~     how the body interacts with drugs), and immune response to BMS-936559, a drug that will be~     administered by an intravenous (IV) infusion, in HIV-infected people receiving combination~     antiretroviral therapy (cART) who have viral load levels below the limit of detection.~   "
117587|NCT02028390|"~     The purpose of this study is to test and evaluate how well a medical imaging device that~     takes both visual and thermal pictures of wounds or body surface areas of interest can help~     collect added information about the wounds or body surface areas of interest in a wound~     clinic.~   "
117588|NCT02028377|"~     This study will use PET/MRI in patients with adenocarcinoma of the pancreas to identify~     hidden metastatic disease or identify patients with borderline or locally advanced disease.~   "
117651|NCT02027558|"~     The purpose of this study is to determine whether a novel intervention combining cognitive~     behavioral therapy for insomnia plus a positive airway pressure (PAP) behavioral adherence~     program provided by allied health personnel for older Veterans with obstructive sleep apnea~     and comorbid insomnia improves nighttime sleep, PAP adherence, mood and health-related~     quality of life.~   "
117589|NCT02028364|"~     This is a prospective, single arm trial in which patients with locally advanced or metastatic~     endocrine receptor positive and HER2 negative breast cancer refractory to non-steroidal~     aromatase inhibitors (NSAI) will receive Everolimus 10mg orally daily given in conjunction~     with exemestane 25mg orally daily until disease progression or treatment discontinuation for~     any other reasons. The main objectives are to evaluate if early metabolic response (MR) using~     FDG-PET/CT is associated with progression free survival (PFS) and overall survival (OS) in~     this population.~      Tumour, metastatic lesions and blood samples will be collected during the treatment period in~     order to identify biomarkers predicting resistance to study treatment. Results will be~     correlated with the results of early FDG PET/CT data in order to better characterise the~     non-responders.~   "
117590|NCT02028351|"~     Purpose of The Study:~      The purpose of this study is the following:~      A)To gather age-related normative visual acuity data for the Vimetrics Central Vision~     Analyzer (CVA, Vimetrics, LLC, Media, Pa) B)To gather visual acuity data for patients with~     known ocular problems, including cataract and maculopathy.~      C)To correlate and compare the CVA visual acuity findings with the acuity measured with~     standard LogMAR acuity charts viewed under similar conditions of contrast and lighting~   "
117591|NCT02028338|"~     To assess the safety of dapivirine (25 mg) administered via a silicone vaginal ring in~     HIV-uninfected adolescent females, when inserted once every 4 weeks during 12 weeks of study~     product use~   "
117592|NCT02028325|"~     The purpose of this study is to evaluate the effectiveness of using Fluorescein Sodium and~     the Yellow 560 microscope to aid in treatment of intracranial tumors and vascular lesions.~   "
117593|NCT02028312|"~     A pilot study to evaluate the impact of Lotemax® Gel (loteprednol etabonate ophthalmic gel~     0.5%) on the initiation of Restasis® (cyclosporine ophthalmic emulsion 0.05%) therapy in~     subjects with dry eye.~   "
117594|NCT02028299|"~     An echocardiogram using Definity contrast can provide the same information as the standard~     right heart catheterization.~   "
117595|NCT02028286|"~     The purpose of this study is to characterize the pharmacokinetics of once daily topical gel~     and confirm that steady state conditions are reached under maximal use conditions following 3~     weeks of daily applications.~   "
117596|NCT02028273|"~     This study is being done to measure the number of brain cells that grow in the brain~     throughout our lives while determining an effective way to complete this with an MRI~     (Magnetic Resonance Imaging) scanner. The number of these brain cells may be affected by~     cocaine use. Researchers are trying to understand the long-term effects of cocaine use on the~     brain.~   "
117597|NCT02028260|"~     This is a randomized, double-blind, placebo controlled study of 30 patients. Patients who~     qualify, as per the inclusion criteria (RASS greater than -3, less then +1, CAM positive,~     present gastric access) will either be given 200mg of modafinil or an identical,~     indistinguishable placebo. The placebo and study drug will be distributed by the hospital~     pharmacy. Once enrolled, each patient will be reassessed every morning to determine~     appropriateness for drug administration. If the RASS is less than -3 (i.e. comatose) or~     greater then 0 modafinil will not be given. He/she will then be assessed each morning~     thereafter. Due to the stimulant-like actions of modafinil, the drug will be administered~     only in the morning. Patients will be assessed for delirium at least twice a day; trained~     personnel using the Confusion Assessment Method (CAM) will do the assessment. Qualification~     for a delirium free day will be no positive CAM screens for 24 hours following drug~     administration. Additional data such as days on mechanical ventilation and progression to~     tracheotomy will also be collected hypothesizing that patients who take modafinil will have a~     shorter time to extubation therefore avoiding the need for a tracheotomy. Post-discharge from~     the unit, but within 48 hours, patients will be asked to participate in a survey (The~     Richards-Campbell Sleep Questionnaire (RCSQ) assessing their perception of daytime and~     nighttime sleepiness in the intensive care unit as well as their overall perception of rest.~     Their functional capacity will also be evaluated at this time and compared to their~     pre-morbid baseline. The hypothesis tested is that Modafinil restores sleep cycle synchrony~     in the ICU therefore increasing delirium free days and improving ICU outcomes.~   "
117598|NCT02028247|"~     Anxiety disorders affect 40 to 50% of children with autism spectrum disorders (ASD),~     contributing to substantial distress and impairment. The goal of this study is to examine the~     effectiveness of a personalized type of psychotherapy against standard-care psychotherapy for~     addressing anxiety in youth with ASD.~   "
117599|NCT02028234|"~     Clopidogrel and Prasugrel are pro-drug necessitating conversion in active metabolites through~     CYP 450 system (CYP), particularly CYP3A and CYP2C19 isoforms.~      These drugs are platelet purinergic receptor antagonists, known as P2Y12. The link between~     active metabolite of Clopidogrel and Prasugrel to P2Y12 receptor prevents ADP receptor~     activation and inhibits several events leading to conformational change of platelets,~     therefore facilitating their activation and aggregation, that is the basis of acute coronary~     syndromes. Proton pump inhibitors (PPI) are actually considered principal agents reducing~     gastroenteric bleeding risk associated to antiplatelet therapy. Nevertheless the interaction~     between PPI and antiplatelet therapy has been object of interest. Several studies~     demonstrated PPI reduce efficacy of clopidogrel on platelet reactivity. Only few data about~     Prasugrel are available showing a minor effect of PPI on its antiplatelet activity than~     clopidogrel. Differing from prasugrel and clopidogrel, ticagrelor is a direct inhibitor of~     P2Y12, not necessitating biotransformation in the liver; therefore its interaction with PPI~     remains unclear. Interaction between omeprazole and clopidogrel seems related to high~     inhibitory activity of PPI on CYP2C19, interfering with the conversion of clopidogrel in its~     active metabolite.~   "
117616|NCT02028013|"~     Bioresonance is the big promise of the medical technology of the future because it stimulates~     the self-regenerating system of the body by affecting the body`s most essential procedures.~     The big advantage is that its multiple and there are no harmful side effects. This therapy~     teaches something to the body what in a younger and healthier state it had already~     Bioresonance is based on the scientific principle that metabolism within cells is influenced~     by one's electromagnetic field.~      We start to use bioresonance technology in management of erectile dysfunction , premature~     ejaculation, decreased libido.~   "
117706|NCT02026843|"~     This study was conducted to investigate the levels of angiogenic factors and anti-angiogenic~     factors in the aqueous humor of patients with diabetic retinopathy.~   "
117600|NCT02028221|"~     Overweight and obesity are well established risk factors for breast cancer that develop after~     menopause. The increased postmenopausal breast cancer risk in women who are overweight or~     obese is likely to be attributed to multiple metabolic disturbances. Metformin is a commonly~     used medication in diabetics to stabilize blood sugar. Association studies and laboratory~     studies have shown its potential to reduce the risk for development of cancer, including~     breast cancer. Recent pilot clinical studies in breast cancer patients suggest that metformin~     may only be effective in overweight or obese women with metabolic disturbances. We propose to~     conduct a clinical study of metformin in overweight or obese premenopausal women with~     metabolic disturbances. Study participants will be randomly assigned to receive metformin or~     placebo for 12 months. The study will evaluate whether metformin can result in favorable~     changes in risk features that have been associated with increased breast cancer risk. The~     risk features that will be examined in our study include breast density, certain proteins and~     hormones, products of body metabolism, and body weight and composition. The study should help~     determine the potential breast cancer preventive activity of metformin in a growing~     population at risk for multiple diseases.~   "
117601|NCT02028208|"~     The purpose of this study is to compare ascending doses of investigational T.R.U.E. Test~     allergens to the marketed petrolatum reference allergen.~   "
117602|NCT02028195|"~     Check your health is a prevention intervention designed to create awareness and action on~     health condition with focus at physical activity at a population-level to 30-49 years of age.~     It consists of a behavioural and clinical examination followed by either (I) referral to a~     health promoting consultation in general practice (II) targeted behavioural programmes at the~     local Health Centre or (III ) no need for follow-up; stratified after risk-profile. The CORE~     trial (Check your health) aim to investigate effectiveness on health and social outcomes of~     the preventive health check and to establish the cost-effectiveness according to life years~     gained; direct costs and total health costs. A pragmatic cluster randomised controlled trial~     has been established to meet the aims and in total 10.600 individuals from 35 practices have~     been randomized in to two groups that will be invited in 2013-14 and 2017-18 respectively.~     The group offered the preventive health check in 2013-14 will constitute the intervention~     group and the group examined in 2017 - 18 the control group. A follow up of the intervention~     group in 2017 - 18 will provide data for the intention to treat analysis revealing the~     effect. Outcome measures are level of physical activity, risk of getting cardiovascular~     disease, sick leave and labor market attachment.~   "
117603|NCT02028182|"~     The purpose of this study is to compare ascending doses of investigational T.R.U.E. Test~     allergens to the marketed petrolatum reference allergen.~   "
117604|NCT02028169|"~     This post marketing observational study is designed to provide the initial data on work~     impairment of PsA patients in Turkey, as well as changes in work impairment, life quality and~     clinical response during treatment with anti-TNF agents.~   "
117605|NCT02028156|"~     This is a non-randomized, single-group, multi-center, two phased study to evaluate formula~     intolerance.~   "
117606|NCT02028143|"~     Imaging Real Time within the Left atrial chamber Enhances safety and efficacy of~     Radiofrequency Ablation of Atrial Fibrillation~   "
117607|NCT02028130|"~     Atrial fibrillation (AF) affects as many as 1 in 16 people over the age of 65 and reduces the~     quality of life of large numbers of people in the UK and around the world. Catheter ablation~     is a minimally invasive treatment that has been developed to help eliminate AF. Recent~     studies have identified that a particular area of the heart, namely the left atrial appendage~     (LAA), which is a pouch in the left atrium (small collecting chamber of the heart), may be~     the main source of AF in many cases. There is a clear lack of knowledge about the structure,~     anatomy, function and electrical properties of the LAA, which is fundamental to furthering~     our understanding and management of AF.~      In addition, it is well known that AF significantly increases the risk of stroke. The~     majority of strokes occur due to blood clots forming in the LAA. Traditionally, the most~     effective treatment to minimise the risk of stroke has been to thin the blood with agents~     such as warfarin. This therapy requires regular blood tests at much inconvenience to patients~     and increases the risk of bleeding complications. Recently, a large study demonstrated that~     use of an implanted device (Watchman®) to occlude the LAA is as effective as warfarin in~     preventing stroke and confers a lower mortality rate.~      We aim to investigate whether it is safe and feasible to ablate the LAA and to implant a~     Watchman® device during the same procedure in patients who are in atrial fibrillation all of~     the time.~   "
117608|NCT02028117|"~     This study is a phase I/II open label clinical study in patients with platinum-resistant~     epithelial ovarian cancer. The Phase I part of the study will determine the dose of~     enadenotucirev to be recommended for further studies and will examine primarily the safety~     and tolerability but also the pharmacokinetics of administering enadenotucirev~     intraperitoneally. Once the dose of IP enadenotucirev to be used in combination with IV~     weekly paclitaxel has been determined, the phase II stage will begin as an open label dose~     expansion of that regimen. The phase II stage aims to determine whether intraperitoneal~     enadenotucirev has a risk benefit profile that supports further investigation in the~     treatment of patients with platinum-resistant epithelial ovarian Cancer.~   "
117609|NCT02028104|"~     The purpose of this study was to study the effect of stem cell therapy on common symptoms in~     patients with Traumatic Brain Injury~   "
117610|NCT02028091|"~     Vascular damage caused by diabetes mellitus, cigarette smoking, age and arterial hypertension~     theoretically changes pulse wave velocity.~   "
117611|NCT02028078|"~     Primary objective is to investigate the feasibility and stability of determining the~     endogenous glucose production during a hypoglycaemic clamp in type 1 diabetes mellitus~     subjects by a stable tracer to tracee ratio with an enrichment of 4% and a variation below~     +/-30%.~      Population: twenty type 1 diabetic subjects~      Study design: Single-center, open, non- randomized, pilot-study~   "
117612|NCT02028065|"~     The purpose of this study is to assess the potential for hypersensitivity symptoms upon~     repeat exposure to sugammadex. Healthy participants will be randomized to one of three~     treatment arms: sugammadex 4 mg/kg, sugammadex 16 mg/kg or placebo. Participants will receive~     3 single intravenous (IV) doses of their randomized treatment, with an approximately 5-week~     washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3. Participants will be~     confined at the study center from the day before each dose until completion of the 24-hour~     post dose assessments.~   "
117617|NCT02028000|"~     The study is looking at women undergoing cesarean section delivery of their baby. The purpose~     of this research study is to determine what type of skin closure after cesarean section helps~     decrease pain level the most and improves the appearance of the incision site.~      The study hypothesis is to determine if skin closure with absorbable subcuticular staples~     leads to improved cosmesis and/or decreased post-operative pain.~      Participants in the study will already be scheduled for a cesarean section for delivery of~     their baby. They will be randomized into one of three groups, 1) Insorb (absorbable~     subcuticular stapes), 2) Vicryl suture or 3) Monocryl suture for the skin closure of their~     cesarean section. Information that will be recorded includes amount of pain medication usage~     while in the hospital after cesarean section, daily patient rated pain score until discharge~     from hospital, pain score 6 weeks after surgery and cesarean section cosmetic scar 6 weeks~     after surgery.~   "
117618|NCT02027987|"~     1. Background:~           Preliminary studies have suggested that valproate acid (VPA) may promote neuron~          survival, inhibit apoptosis, decrease the neuron function deficit in cerebral ischemia,~          and promote the brain functional recovery after traumatic brain injury (TBI). Besides,~          in the guide of prevention and treatment of epilepsy in 2007, VPA was one of the~          antiepileptic drugs which were suggested to prevent early epilepsy after TBI (less than~          7 days).~        2. Objectives:~           Our main objective was to evaluate whether VPA could protect brain and improve recovery~          of brain function after severe TBI. The secondary objective was to explore whether VPA~          could prevent late epilepsy after severe TBI (more than 7 days).~        3. Methods:~      We would enroll 160 patients who were in a vegetative or minimally conscious state 4 to 16~     weeks after TBI and who were receiving inpatient rehabilitation. Patients were randomly~     assigned to receive VPA or placebo for 4 weeks and were followed for 2 weeks after the~     treatment was discontinued. The rate of functional recovery on the Disability Rating Scale~     (DRS; range, 0 to 29, with higher scores indicating greater disability) was compared over the~     4 weeks of treatment (primary outcome) and during the 2-week washout period with the use of~     mixed-effects regression models.~   "
117619|NCT02027974|"~     The purpose of this study is to evaluate the use and efficacy of the Iconacy Hip System for~     total hip replacement surgery.~   "
117620|NCT02027961|"~     The purpose of this study is to determine the maximum tolerated dose and the safety profile~     of MEDI4736 in combination with dabrafenib and trametinib or with trametinib alone in~     subjects with metastatic or unresectable melanoma with BRAF-mutation positive or Wild Type~     BRAF, respectively.~   "
117621|NCT02027948|"~     Patients with esophageal and gastroesophageal junction (GEJ) cancer often have weight loss,~     swallowing problems, and poor appetite. This may affect their ability to tolerate cancer~     treatment.~      The purpose of this study is to see if the researchers can apply a set of nutrition~     guidelines designed specifically for patients with cancer who are older than 65 years of age.~     The questions will allow them to assess the nutritional status and make appropriate~     referrals. If the patients are having swallowing problems or losing weight, the researchers~     want to address the nutritional problems early in the course of their treatment.~   "
117622|NCT02027935|"~     The goal of this clinical research study is to learn about the safety of giving CD8+T cells~     with ipilimumab, cyclophosphamide, and IL-2 (aldesleukin). Researchers also want to learn if~     this combination can help to control metastatic melanoma (melanoma that has spread).~      This study is divided into 2 parts: leukapheresis and treatment. In the leukapheresis part,~     blood cells will be collected from you to be made into modified CD8+T cells and given back to~     you in the treatment part.~      CD8+T cells are a type of white blood cell. Researchers grow the T cells in the laboratory,~     and they are designed to find melanoma cancer cells and may kill them.~      Ipilimumab and aldesleukin are designed to increase the immune system's ability to fight~     cancer.~      Cyclophosphamide will be used at a very low dose to weaken the body's natural defense against~     the T-cell transplant, so that the transplanted T-cells have a chance to grow and multiply.~   "
117623|NCT02027922|"~     The study is to compare the prophylactic and therapeutic clinical effectiveness of two~     fluoride varnishes in children at high caries risk.~      It was hypothesized, the use of Fluor Protector S (I) fluoride varnish in children with~     deciduous teeth at high risk of caries (P) reduces caries and the activity/remineralisation~     of carious enamel spots (transformation of White Spot Lesion into D (decay)) (O), similarly~     to what occurs after the use of Duraphat varnish (C).~   "
117624|NCT02027909|"~     Providing ideal rate response to patients should improve their quality of life and ability to~     execute activities of daily living.~      Medtronic pacemakers provide rate response pacing by utilizing dual zone programming to~     specify an activities of daily living (ADL) response rate and an exertion response rate.~     There is much data to support the target heart rate for an exercise response but the data to~     support the programming of the ADL rate is lacking.~   "
117625|NCT02027896|"~     HIP ATTACK is an international randomized controlled trial of 3000 patients with a hip~     fracture that requires a surgical intervention. This trial will determine the effect of~     accelerated medical clearance and accelerated surgery compared to standard care on the 90-day~     risk of mortality and major perioperative complication (i.e., a composite of mortality,~     nonfatal myocardial infarction, nonfatal pulmonary embolism, nonfatal pneumonia, nonfatal~     sepsis, nonfatal stroke, and nonfatal life-threatening and major bleeding).~   "
117626|NCT02027883|"~     As the indications for Implantable Cardioverter Defibrillator implantation expand, minimizing~     implant time is critical. Also, patients receiving biventricular ICDs are sometimes more~     unstable and minimization of sedation time is crucial. Multiple induction attempts, with a~     1-Joule shock, can cause disruption in lead position. Therefore limiting the number of~     attempts will allow for better lead stability throughout the procedure and a more~     straightforward implant process.~      Investigator proposes a detailed documentation of success rates from various Ventriculart~     Fibrillation induction methods during implant of Medtronic defibrillation capable devices.~   "
117627|NCT02027870|"~     The study aims to further assess the safety, efficacy and the performance of its delivery~     system of the new generation Sirolimus-eluting stent of JWMS up to five years.~   "
117707|NCT02026830|"~     To determine the causative microorganisms and their antibiotic sensitivity patterns in~     diabetic patients with a foot infection in Turkey.~   "
117708|NCT02026817|"~     To compare the pharmacokinetic characteristics between HCP1201 tablet 750/10 mg and~     co-administration of metformin 750 mg plus rosuvastatin 10 mg under fed state condition.~   "
117628|NCT02027857|"~     Brain edema is the main reason for the disability and lethality in traumatic brain injury,~     which is the most difficult part of emergency rescue. Recently, there is no medical equipment~     to monitor the early brain edema in clinic. We have found that Electrical impedance~     tomography (EIT) can perform the real-time and bedside monitoring of brain electrical~     impedance after single-dose mannitol treatment, which may be a new strategy for the~     surveillance of brain edema. In this study, we would like to compare the application in~     traumatic brain edema between EIT and Noninvasive intracranial pressure (ICP) monitoring,~     including the progress of brain edema, the relationship between impedance and ICP, and the~     improvement for the patients' prognosis. EIT would probably be a new image strategy for the~     treatment of traumatic brain injury.~   "
117629|NCT02027844|"~     Nearly 50% of young children undergoing surgery exhibit high level of anxiety during~     induction of anesthesia because of exposure to unfamiliar environment and people and~     separation from parents. Increased preoperative anxiety may impact postoperative behavior~     changes such as emergence agitation, separation anxiety and sleep disturbance. Although some~     pediatric anesthesiologists routinely permit parental presence to reduce the anxiety during~     induction of anesthesia, previous studies have reported conflicting results. Recently the~     distraction using video game or animated cartoon has been reported to reduce anxiety of young~     children during induction of anesthesia. However, it was still undetermined whether~     distraction has its own ability to reduce children's anxiety separated from parental presence~     because they evaluated the effect of video method in the parental presence. The investigators~     design to investigated the efficacy of distraction with watching cartoon, parental presence~     and combined with watching cartoon and parental presence on reduction of anxiety during~     inhalational induction of anesthesia using sevoflurane. In addition this study includes~     long-term effect of each intervention such as postoperative emergence agitation and~     postoperative behavior change in children.~   "
117630|NCT02027831|"~     The purpose of this study is to determine if NIR fluorescent imaging is an effective approach~     to detect the margins of head and neck tumours or lymph nodes draining the tumour~   "
117631|NCT02027818|"~     We will observe if ICG fluorescence correlates with margins of breast tumours after iv~     injection of the contrast agent~   "
117632|NCT02027805|"~     In this study, a combination of two antibodies both conjugated to a cell-killing toxin~     (so-called immunotoxins) will be evaluated. The antibodies are directed against T-cell~     antigens 'cluster of differentiation 3 antigen' (CD3) and CD7. Previous in vitro studies have~     demonstrated that this particular immunotoxin-combination, named T-Guard, acts~     synergistically in eliminating T cells with a preference for killing activated T-cells. In a~     subsequent clinical pilot-study, T-Guard has generated encouraging results when applied as~     third-line therapy for patients suffering form steroid-resistant acute Graft-versus-Host~     Disease (GVHD). Extensive biological and clinical responses could be noted in the absence of~     severe acute toxicities. Building on these results, the current study aims at evaluating the~     safety and efficacy of T-Guard for treating steroid-resistant GVHD when administered in an~     earlier phase of the disease process, i.e. as second-line instead of as third-line therapy.~   "
117633|NCT02027792|"~     This randomised controlled trial aims to investigate the efficacy of cabbage leaf cataplasms~     in the treatment of primary symptomatic osteoarthritis of the knee. 81 patients will be~     randomised into one of 3 groups and apply either cabbage leaf cataplasm or diclofenac gel~     daily for 4 weeks or receive only usual care. Efficacy will be measured using questionnaire~     on pain, disability, quality of life and pressure pain sensitivity.~   "
117634|NCT02027779|"~     This study primarily will address the safety and secondarily will assess efficacy of~     GreenGene™ F in subjects with severe hemophilia A previously treated ≥50 exposure days with a~     GreenGene™ F, and without presence inhibitor to FVIII (Factor VIII).~   "
117635|NCT02027766|"~     Stretching is frequently used in clinical practice to manage musculoskeletal discomfort and~     to prevent sports injuries. It is not known if stretching affects pain sensitivity. The~     purpose of this study is to investigate if a 4 week daily stretching protocol alters pain~     sensitivity.~      The investigators hypothesize that stretching reduces pain sensitivity.~   "
117636|NCT02027753|"~     Primary Objective:~      To investigate the efficacy(HbA1c) at 6 months after adding basal insulin therapy (insulin~     glargine) to dipeptidyl peptidase-IV (DPP-IV) and metformin plus or minus sulphonylurea~      Secondary Objectives:~        1. To assess the efficacy by adding insulin glargine~        2. To assess insulin dose~        3. Safety~   "
117637|NCT02027740|"~     This prospective cohort study of an almond-enriched diet (within the overall context of Asian~     Indian dietary guidelines) was conducted to test the hypothesis that in patients with T2DM~     almond-enriched balanced diet improves glycemic measures and CVD risk factors.~   "
117638|NCT02027727|"~     The purpose of this study is to determine which early infliximab pharmacokinetic level is~     most associated with clinical remission at weeks 30 and 54 in pediatric IBD patients.~   "
117639|NCT02027714|"~     The purpose of this study is to gather information needed to develop a large prevention trial~     to decrease the risk for HIV transmission among HIV-discordant couples (where one person is~     HIV-positive and the other is HIVnegative) in Lesotho. The protocol team would like to learn~     more about men, women and couples in Lesotho and what they think about various topics related~     to HIV, including HIV testing and counseling, male circumcision and HIV treatment.~      There will be three parts to the study including 1) a survey 2) focus group discussions; and~     3) in-depth interviews. Two hundred pregnant or recently postpartum women will be recruited~     to participate in the survey. Women who answer the questionnaire will also be asked to~     participate in the focus groups. A total of 6-8 groups consisting of 6-12 women each will be~     conducted. Thirty men from the community will be recruited to participate in an in-depth~     individual interview.~   "
117650|NCT02027571|"~     The reasons for the epidemics of diabetes and prediabetes, and why individuals from certain~     populations suffer at higher rates are not well known. In the Pathobiology and Reversibility~     of Prediabetes in a Biracial Cohort (PROP-ABC) study, nearly 400 African Americans and~     Caucasians whose parents have type 2 diabetes will undergo repeated testing to determine what~     factors lead to the occurrence of prediabetes, and whether race still plays a major role in a~     setting where everyone being studied has one or both parents with diabetes. The PROP-ABC~     Study also will test the hypothesis that the ability of intensive lifestyle intervention to~     reverse prediabetes and return people's metabolism back to normal is dependent on how long~     people have had prediabetes.~   "
117640|NCT02027701|"~     This study is an extension study to the pivotal study IgPro20_3003 (NCT01545076). The purpose~     of this extension study is to investigate the long-term treatment of CIDP with IgPro20, with~     regard to safety and efficacy.~      Subjects who have completed subcutaneous (SC) Week 25 or were successfully rescued from a~     CIDP relapse during the SC Treatment Period of pivotal study IgPro20_3003 (NCT01545076) will~     have the option to receive open-label low-dose IgPro20 (0.2 g/kg bodyweight [bw]) weekly for~     up to 48 weeks. Subjects relapsing on low-dose IgPro20 will either return to high-dose~     IgPro20 (0.4 g/kg) immediately or be discontinued, depending on investigator's judgment.~     Subjects returning to high-dose IgPro20 will continue on high-dose until they have completed~     a total of 48 weeks of IgPro20 treatment. If subjects do not successfully recover from CIDP~     relapse within 4 weeks, they will be withdrawn.~      The treatment duration will be up to 48 weeks, followed by a completion visit (week 49).~   "
117641|NCT02027688|"~     Preterm infants face many feeding challenges during hospitalization which can prolong~     hospitalization, raise parental anxiety and can lead to medical instability. The Feeding~     Progression study will randomize preterm infants to one of two currently accepted oral~     feeding schedules; oral feed attempts every 3 hours or every 6 hours. The study will collect~     data on oral feeding success, milk transfer, sucking strength, growth and medical~     complications.~   "
117642|NCT02027675|"~     In a society where exercise is prescribed by physicians to increase physical condition,~     improve dietary habits and reduce cardiovascular risk, the impact of exercise, acute or~     chronic, and diet in inflammation and immunity is unknown. Specific populations can have~     different responses towards acute and chronic exercise. Moreover specific conditions, like~     the type of meal ingested, can interfere with these responses. The true effect of~     pre-competitive meal exercise in the immunity and inflammatory response is unknown. Acute~     physical inactivity periods, commonly happens during daily life, related to work or acute~     illness. New evidence points out that it induces immediate metabolic and endocrinological~     changes, these can might also be associated with changes in immune response.~      Aims of this project are:~        1. to assess the effect of the precompetitive meal on the inflammatory, neuro-immune and~          metabolic response to exercise;~        2. to assess the effects of sedentary behaviour on inflammatory, neuro-immune and metabolic~          response;~        3. to assess differences in changes between healthy, asthmatic and obese subjects~   "
117643|NCT02027662|"~     Phosphate binders are crucial to the control of elevated phosphate levels in patients with~     chronic kidney disease. With the new formulation of granules the pill burden of patients is~     sought to be reduced.~      This study is about efficacy and safety of the new drug formulation and compares it to the~     old formulation which are film-coated tablets.~   "
117644|NCT02027649|"~     By an invasive technique keratin 14 has been identified as a prognostic factor in bladder~     cancer. This study aims to analyze whether through a non-invasive technique keratin 14 can be~     used as a diagnostic and prognostic marker for this cancer.~   "
117645|NCT02027636|"~     Our study tested the effectiveness of a combined cognitive behavioral therapy (CBT) and care~     manager intervention offered either by telephone or face-to-face with depressed Latinos~     identified in primary care. Eligible patients were randomized after baseline to one of three~     conditions; 1) ECLA-T (telephone) intervention, 2) ECLA-F (face to face) intervention, and 3)~     usual care. Usual care was considered care as usual in the participating clinic for a patient~     screening or depression. The ECLA-T intervention was based on a~     telephone-plus-care-management intervention that has been shown to be effective in decreasing~     depressive symptoms and increasing client satisfaction and self-perceived global improvement,~     as compared to usual care in depressed patients in primary care settings.~   "
117646|NCT02027623|"~     Exercise is one of the primary interventions used with people with chronic, mechanical low~     back pain. It is unknown, however, which exercise is best for which person, which exercises a~     person will adhere to and for how long, and the effect of adhering to a specific type of~     exercise on how the person functions, particularly in the long run. The purpose of this study~     is to examine if the short- and long-term effects are different between 1) commonly~     prescribed strength and flexibility exercises for the trunk and limbs, and 2) individualized~     practice in daily functional activities that are difficult or painful to perform. Adherence~     to the different interventions, the relationship between adherence and outcomes,as well as~     the effect of a booster intervention also will be examined.~   "
117647|NCT02027610|"~     Vitamin A deficiency (VAD) increases the risk of death from infections in infants and young~     children. The World Health Organization (WHO) recommends high-dose vitamin A supplementation~     (VAS) from 6-59 months of age to reduce the risk of death in countries where VAD is common.~     Such countries include Bangladesh, where this study is being conducted. While providing VAS~     at 6 months is recommended, providing VAS at birth may also decrease the risk of death since~     newborn infants are also at risk of VAD. VAS presumably reduces infant mortality by improving~     the immune response to infection and immunization. Vitamin A particularly affects the~     development and function of T cells, which develop in the thymus and are a key component of~     the memory response to infection and immunization. Vitamin A is important for development of~     an important class of T cells, regulatory T-cells, in the intestine. Regulatory T-cells~     prevent over-reaction of the immune system to substances the immune system might otherwise~     treat as harmful such as food or the healthy bacteria in the intestine. VAD could disrupt the~     normal colonization of the infant's intestinal tract and cause a condition called dysbiosis~     where abnormal bacteria flourish and adversely affect the infant's immune system. Dysbiosis~     may disrupt the immune response to injectable and oral vaccines. VAS at birth may prevent~     dysbiosis and thus improve immune function, response to vaccines, and child survival. The~     investigators recently completed an intervention trial in Bangladeshi infants (NCT01583972)~     examining the effect of VAS at birth on immune function and response to vaccines administered~     from birth to 14 wk of age. The present study will recruit infants who completed NCT01583972~     when they are from 12 to 24 m of age to determine if VAS at birth affects the responses to~     these same vaccines when they are measured during the second year of life. The investigators~     will examine the effect of VAS at birth on gut microbiota measured early in infancy and~     during the second year of life, and explore the association of the gut microbiota with~     vaccine response. Mothers of study infants will participate in the study because the breast~     milk oligosaccharide content strongly affects gut microbiota composition and the secretor~     status of the mother, which can be determined from maternal FUT2 genotype, strongly affects~     breast milk oligosaccharide content.~   "
117648|NCT02027597|"~     This study investigated if computer games can be effective at changing the way children take~     care of their teeth. We a museum exhibit with 3D virtual reality games called Attack of the~     S. Mutans! Our hypothesis was that children who played the games and visited the exhibit~     would show improved attitudes about oral health, which would translate into improved brushing~     and self-care habits.~      In this randomized controlled study with school children aged 8-12, we compared the outcomes~     for three groups: Group 1) Visited Attack of the S. Mutans!; Group 2) Experienced a hands-on~     classroom presentation about virtual reality being used for healthcare; Group 3) Received~     no-treatment.~   "
117649|NCT02027584|"~     To study concentrations of choline, its metabolites, and phospholipids in cord blood and~     remnants of clinically indicated blood samples~   "
117652|NCT02027545|"~     Systematic efforts to improve colorectal cancer screening use in the VA Healthcare System~     have resulted in an increase in not only appropriate, but also inappropriate use of~     screening. The purpose of this study is to test a new, more patient-centered approach to~     colon cancer screening. In older individuals (ages 70 to 75) who are due for screening, the~     investigators will provide education on the benefits and harms of colon cancer screening. But~     instead of simply providing these patients with average information about these benefits,~     the investigators will give them information that takes into account their personal~     characteristics (e.g., age, gender), overall health, and screening history and therefore~     applies to them more personally. The investigators will also work with the health system to~     create time and space for patient and doctor to discuss whether screening is the right choice~     for each individual. This way, patients can make an informed choice about what is right for~     them, with the help of their doctor. In the future, the results of this study will help~     patients make more informed screening decisions, especially when the benefits of screening~     may be uncertain for them personally.~   "
117653|NCT02027532|"~     The purpose of this study is to compare the incidence rate of infection in surgical patients~     with closed fractures treated prophylactically with Cefazolin versus Vancomycin in the~     peri-operative period.~      The hypothesis of this study is that patients undergoing surgical treatment for closed~     fractures who are treated prophylactically with Vancomycin will have a lower incidence rate~     of infection than patients who are treated prophylactically with Cefazolin.~   "
117654|NCT02027519|"~     The purpose of this study is to gather information needed to develop a large prevention trial~     to decrease risk for Human Immunodeficiency Virus (HIV) transmission among HIV-discordant~     couples (where one person is HIV-positive and the other is HIV-negative) in Lesotho. The~     protocol team would like to explore new strategies for increasing the number of partners who~     receive an HIV test and whether this increase in testing also results in identifying~     HIV-discordant couples. These couples would be the focus of the future large prevention~     trial, therefore it is critical that the protocol team explore effective strategies for~     identifying and recruiting these couples. Men and women (index participants) who are~     attending Antenatal Care (ANC),Tuberculosis (TB) and antiretroviral therapy (ART) clinics~     will be recruited for this study. If they agree to take part, a testing team will visit their~     household and offer all adults staying in the house the opportunity to conduct a self-test~     for HIV. Seventy-ﬁve index participants will be enrolled into the study and have their homes~     visited by the testing team. The number of household members tested will depend on the number~     of people living in each household.~   "
117655|NCT02027506|"~     The electrocardiogram (ECG) is a simple and non-invasive bedside diagnostic tool with a~     well-established role in the diagnosis of (CAD). Many studies have found that the admission~     of ECG provides important prognostic information in patients admitted with chest pain. For~     instance, T wave inversion in anterior or inferior location and or ST-segment depression has~     been associated with high incidence of CAD.~   "
117656|NCT02027493|"~     Egypt has the highest prevalence of hepatitis C virus infection in adults (up to 20%) and~     children (up to 5.5%). The major genotype (90%) is type 4. Pegylated interferon-alpha-2a or~     -2b and ribavirin have been used in small numbers of hepatitis C virus-infected children with~     sustained virological response being higher in genotypes 2 and 3 than in genotypes 1 and 4.~     Genotype 4 is has been described as difficult-to-treat genotype. Several attempts to modify~     treatment protocols have been tried in adults in an attempt to achieve higher rates of~     sustained virological response. Shortening injection interval and/or treatment duration~     prolongation have been tried with variable outcome reports.~      A novel Hansenula- derived pegylated interferon alpha 2a: 20 Kilo dalton (Reiferon Retard)~     has been used over the last 4 years in the Egyptian market.~      We aimed to investigate the safety and efficacy of Reiferon retard plus ribavirin customized~     regimen in hepatitis C virus-RNA seropositive Egyptian children. Forty six children with~     chronic hepatitis C virus aged 3-19 years were selected from 3 hepatic tertiary centers.~      Clinical and laboratory evaluation were undertaken. Quantitative polymerase chain reaction~     (PCR) for HCV-RNA was done before starting treatment, at 4, 12, 24, 48, 72 weeks during~     treatment and 6 months after stoppage of treatment. All patients were assigned to receive a~     weekly subcutaneous injection of pegylated interferon alpha 2-a ( Reiferon Retard) plus oral~     Ribavirin daily for 12 weeks ,then cases were divided according to PCR results into 2 groups.~      Group I: Patients who continued treatment on weekly basis: this group included patients who~     had negative PCR at week 12 as well those who had positive PCR without any change in viremia.~     Group II: Patients who continued treatment on a 5- days schedule: this group included~     patients who had any decrease in viremia at week 12.~      Patients who were PCR-negative at week 48 and had at least one PCR-positive test during~     therapy were assigned to have an extended treatment course of 6 months duration.~      The occurrence of adverse effects was assessed during treatment and follow up~   "
117657|NCT02027480|"~     The aim of this study is to develop and follow a cohort of human immunodeficiency virus~     (HIV)-infected adults who are starting HIV drugs at health facilities in Kenya. Blood and~     urine samples will be collected from all participants in order to establish a sample bank of~     samples in order to further the understanding of the levels of inﬂammatory biomarkers and~     coagulation biomarkers in African patients and the effect of taking HIV drugs on these~     biomarkers. This study will enroll and follow 685 men and women who are starting HIV drugs~     and collect blood and urine specimens from them at 4 study visits. These samples will be~     frozen and stored for future testing related to inﬂammatory and coagulation biomarkers.~   "
117658|NCT02027467|"~     Combination of various herbs is known to promote mobilization of hematopoietic stem cells.~     Hence the current study has been intended to study the effect of Stem Alive® on mobilization~     of stem cells. Stem Alive® include ingredients like green tea, ashwagandha, etc which are~     known to be used as traditional medicine. They are also tested qualitatively in academic and~     nutritional science research centers throughout the world and which substantially according~     to those studies stimulate the augmented availability of circulating hematopoietic cells.~     This study is projected to investigate the mobilization of stem cells on healthy human~     volunteers.~   "
117659|NCT02027454|"~     This study is being conducted to comply with the Food and Drug Administration (FDA)~     recommendation that all new non anti-arrhythmic drugs be assessed for cardiac repolarization~     effects through electrocardiographic evaluation. Therefore, this study will evaluate the~     effect of GSK1265744 on cardiac conduction as assessed by collection of twelve-lead~     continuous digital data in healthy adults. This study will evaluate the effect of three doses~     of GSK1265744 on the QT duration corrected for heart rate (QTc) interval as compared to~     placebo. Moxifloxacin will be used as a positive control in order to validate the sensitivity~     of the study in detecting QTc change. This study consists of three treatment periods (each~     separated by 21 day washout period) followed by follow-up visit 10 to 14 days post last~     dosing. The total duration of study including follow-up visit will be approximately 62 days.~     Approximately 42 subjects will be enrolled such that 34 subjects complete dosing and critical~     assessments.~   "
117660|NCT02027441|"~     The purpose of this study is to gather information needed to develop a large prevention trial~     to decrease risk for Human immunodeficiency virus (HIV) transmission among HIV-discordant~     couples (where one person is HIV-positive and the other is HIV-negative) in Lesotho.~      The protocol team would like to explore new strategies for increasing the number of partners~     who receive an HIV test and whether this increase in testing also results in identifying~     HIV-discordant couples. These couples would be the focus of the future large prevention trial~     therefore it is critical that the protocol team explore effective strategies for identifying~     and recruiting these couples.~      Men and women (index participants) who are attending antenatal (ANC) and Tuberculosis (TB)~     clinics will be recruited for this study. If they agree to take part, a testing team will~     visit their household and offer all adults staying in the house the opportunity to receive an~     HIV test.~      Three hundred index participants will be enrolled into the study and have their homes visited~     by the testing team. The number of household members tested will depend on the number of~     people living in each household.~   "
117661|NCT02027428|"~     Maintenance treatment of advanced stage squamous cell NSCLC~   "
117662|NCT02027415|"~     The study hypothesis is that drinking different juices will affect the body's responses to~     air pollution. Subjects will be exposed to air pollution during a 2-hour car ride on the NJ~     (New Jersey) Turnpike. Each subject will be asked to do this twice. Before one car ride, the~     subject will be asked to drink orange juice. Before the other car ride, the subject will be~     asked to drink beet juice. Samples of blood and exhaled breath will be collected before,~     immediately after, and 24 hours after each car ride. Levels of nitrites/nitrates will be~     measured in the blood and breath.~   "
117663|NCT02027402|"~     During laparoscopic surgery for an acutely inflamed gallbladder, most surgeons routinely~     insert a drain. However, no consensus has been reached regarding the need for drainage in~     these cases, and the use of a drain remains controversial. This study is coordinated to find~     out the surgical outcomes and perioperative morbidity according to the insertion of drain~     after laparoscopic cholecystectomy. Investigators expect that the routine use of a drain~     after laparoscopic cholecystectomy for an acutely inflamed gallbladder will have no effects~     on the postoperative morbidity.~   "
117664|NCT02027389|"~     The objective of this study is to evaluate the impact of the Alere&#8482; PBP2a test combined~     with pharmacist review of antimicrobial therapy, on clinical outcomes and cost in~     hospitalized patients with sterile site S. aureus infection.~   "
117665|NCT02027376|"~     This is a single-arm, open-label, phase Ib study. In this trial, patients with Triple~     Negative (TN) Advanced Breast Cancer (ABC) will be treated with increasing doses of LDE225~     and docetaxel to determine the MTD (Maximum Tolerated Dose), DLT (Dose Limiting Toxicity) and~     RP2D (Recommended Phase II Dose) of the combination.~      Eligible patients with hormonal receptors negative and HER2 negative ABC will be included and~     treated with docetaxel intravenously in every three weeks cycles. LDE225 will be administered~     orally at three dose levels 400, 600 and 800mg QD (a -1 dose level is included just in case~     dose de-escalation is needed). Treatment will be repeated on day 1 of a 21-day cycle until~     radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.~      The investigators propose to develop a phase Ib trial with the combination of docetaxel with~     LDE225 in TN ABC patients to define the safety, tolerability and RP2D, as well as to have~     some information about the efficacy of the combination.~      Primary Objective:~      To determine the MTD and RP2D of LDE225 administered orally in combination with docetaxel in~     TN ABC patients.~      Primary End-point:~      To determine the incidence rate of DLT within the first two cycles of LDE225 in combination~     with docetaxel at each dose level.~      Secondary Objectives:~        -  To determine the safety and tolerability of LDE225 given in combination with docetaxel.~        -  To characterize the effects of LDE225 in combination with docetaxel on QTc intervals and~          their correlation with systemic drug exposure.~        -  To evaluate the efficacy of the combination of docetaxel with LDE225 in TN ABC patients.~        -  To evaluate the Pharmacokinetics (PK) of the combination of docetaxel with LDE225.~      Secondary End-points:~        -  Safety will be assessed by standard clinical and laboratory tests (hematology, serum~          chemistry). Adverse events grade will be defined by the NCI CTCAE v4.0.~        -  Changes in QT/QTc from baseline ECG values and correlation with systemic drug exposure.~        -  The efficacy endpoints are Time To Progression (TTP) and Objective Response Rate (ORR).~          TTP is measured from the initiation of treatment till disease progression and ORR is~          defined by RECIST 1.1 criteria as complete response rate + partial response rate.~        -  The PK will determine whether LDE225 influences the pharmacology of docetaxel. Blood~          samples will be taken at the times defined in the protocol.~      Exploratory Objectives:~        -  To study potential predictive biomarkers of efficacy by evaluating activation of Hh~          signaling pathway and related pathways.~        -  To analyze the pharmacodynamic (PD) treatment effects on the expression of Smo related~          biomarkers and Hg target genes in correlative samples.~        -  To correlate biomarker, PD and PK findings with efficacy and toxicity data.~      Exploratory End-points:~        -  Hh gene expression signature associated to pathway activation (at least Shh, Smo, Ptch1,~          Ptch2, Gli1, Gli2), analyzed in tumor samples.~        -  Changes in Smo related pathway biomarkers (at least Gli1) in skin and blood correlative~          samples.~        -  Pharmacodynamic and biomarker analysis results will be correlated with PK findings,~          efficacy and toxicity data.~      Demographics and Baseline Characteristics:~      Standard descriptive statistics, such as the mean, median, range and proportion, will be used~     to summarize the patient sample and to estimate parameters of interest. Ninety-five percent~     confidence intervals will be provided for estimates of interest wherever possible.~      Safety Analyses:~      Adverse events data and serious adverse events will be reported in frequency tables (overall~     and by intensity). The safety analysis will be performed in the population that has received~     at least one dose of the drugs.~      Efficacy Analyses:~      Response will be analyzed in patients with measurable disease that have received at least one~     dose of the drugs.~      TTP will be evaluated in all patients that have received at least one dose of the drugs.~      Study population:~      Patient with hormonal receptors negative and HER2 negative ABC.~   "
117666|NCT02027363|"~     Colorectal cancer is one of the most common malignant tumors, with the morbidity of~     approximate 100 million cases per year. About 40% of patients present with metastatic (stage~     IV) colorectal cancer at the time of diagnosis, and about 25% of patients with local lesion~     will ultimately develop metastatic disease.~      5-Fluorouracil（5-FU) was the only efficacious treatment for metastatic colorectal cancer~     before the nineties of the 20th century, and afterwards as the discovery of chemotherapy such~     as oxaliplatin, irinotecan and capecitabine, response rate as well as survival had been~     improved greatly.~      Most of advanced colorectal cancer will progress after first-line treatment; therefore,~     seeking an efficient and low toxic maintaining regimen to prolong PFS becomes a hot topic in~     oncologic field. Some clinical researches demonstrated that maintaining treatment followed~     first-line treating advanced NSCLC could extend PFS and OS. In metastatic colorectal cancer,~     patients receiving 5-FU/leucovorin(LV) maintaining therapy experienced significantly longer~     PFS than that stopped chemotherapy after six cycles of FOLFOX4 in OPTIMOX2 study. One phase~     II study shown that median PFS was 13.9 months, and median OS was 31 months in 30 patients~     receiving first-line treatment of six- month FOLFOX4 followed by UFT as maintaining treatment~     . A non-randomized small sample study conducted in department of medical oncology of Sun~     Yat-Sen University Cancer Center indicated that patients receiving first-line treatment of~     XELOX followed by capecitabine as maintaining therapy has significantly prolonged median TTP,~     comparing with the non-maintaining treatment patients,(14months vs. 9 month, respectively).~      Above all, so far, there is no data to demonstrate that regular 4-6 month chemotherapy~     followed by maintaining treatment could prolong TTP and OS for advanced colorectal cancer.~     Capecitabine is effective for colorectal cancer, and was approved as palliative treatment for~     advanced colorectal cancer and adjuvant chemotherapy; in addition, with its relative less~     frequency of side effects and convenient oral administration, capecitabine as maintaining~     regimen could be prone to be accepted by patients. Therefore, our study is designed to~     investigate that capecitabine as maintaining treatment after first-line palliative~     chemotherapy could improve TTP and OS for patients with advanced colorectal cancer through a~     perspective randomized clinical study.~   "
117667|NCT02027350|"~     Until now, diagnosis of constriction was based on pressure changes of ventricle by~     conventional pressure-wide hemodynamic evaluation but not on ventricular volume change. This~     study will provide answers to persisting questions about volume changes during respiration in~     patients with constrictive pericarditis by directly measuring both right and left ventricular~     volume.~   "
117668|NCT02027337|"~     We investigate parameters of hemocoagulation and lipoperoxidation in women using combined~     oral contraceptives with antiandrogenic activity (containing drospirenone with 20 or 30 mcg~     ethinylestradiol; or cyproterone acetate); correction of these changes by antioxidants~   "
117669|NCT02027324|"~     There are approximately 1.4 million cesarean deliveries in the United States each year, and~     an average of 1250 elective cesarean deliveries each year at the Brigham and Women's Hospital~     (BWH) in Boston, Massachusetts. Among cesarean deliveries performed at BWH, approximately 2%~     of patients are diagnosed with a surgical site infection (SSI). Because SSI is associated~     with significant morbidity and increased cost of care, numerous guidelines exist to guide~     preoperative administration of prophylactic antibiotics. However, there are no~     recommendations for the choice of antiseptic solution for prevention of SSI. Among the~     currently popular antisepsis preparations, chlorhexidine-alcohol (CA) is known to decrease~     SSI in non-obstetric surgeries. However, the time required for CA to dry (~ 3 min) to~     minimize flammability risk is disadvantageous in the setting of emergent cesarean delivery.~     Many institutions use povidone-iodine, another antisepsis preparation that does not require~     the mandatory drying time. Our randomized study aims to compare the incidence of SSI in~     patients receiving either CA or PI during elective cesarean delivery, and we hypothesize that~     CA would be associated with a lower incidence of SSI.~   "
117670|NCT02027311|"~     Recently up-coming drug, etomidate which is a modulator of GABA(gamma-Aminobutyric acid)-A~     receptor has been known that it maintains the appropriate sedative levels and affects little~     effects on respiratory system.~      The investigators are now trying to investigate that etomidate with meperidine combination~     regimen is superior to the midazolam with meperidine more effective and less harm on sedation~     during the ERCP procedure.~   "
117671|NCT02027298|"~     The primary purpose of this pilot study is to evaluate the efficacy and safety of Abatacept~     in subjects with Sjogren's Syndrome (SS). This clinical trial study will enroll and treat 15~     subjects with active moderate and severe inflammatory arthritis associated with primary~     Sjogren's syndrome (pSS) and secondary Sjogren's sybdrine (sSS) with Rheumatoid Arthrits~     (RA). All subjects will receive Abatacept weekly by Subcutaneous (SC) dosing. Subjects will~     receive Abatacept by SC injection of 125 mg on day 1 and followed by 125 mg SC weekly~     thereafter.~   "
117672|NCT02027285|"~     The study Nutritional trial with fortified milk in 65+ years old subjects is a part of a~     complex research project and multi-sectoral development (MIAO 50) with the participation of~     University Research Institutes and small and medium Italian enterprises.~      The general objective of the call is to promote the collaboration between the best scientific~     knowledge, both epidemiological and experimental, and the most advanced technologies to~     develop foods with a nutritional profile adequate to the needs of consumers with an age over~     50 years old, which are easy to use and make it possible to eat in a healthy manner, complete~     and balanced and also meets the quality and flavors of traditional Italian.~   "
117673|NCT02027272|"~     This is a double blinded, placebo-controlled trial to determine if IV dexamethasone more~     quickly than placebo assists resolution of Posterior Reversible Encephalopathy Syndrome~     (PRES) encountered in eclamptic patients. All patients regardless of assignment to placebo or~     steroid will receive standard therapy to include magnesium sulfate, blood pressure~     medications and diuretics. We hypothesize that the addition of dexamethasone to standard~     therapy will accelerate CNS recovery more quickly than standard management without~     dexamethasone.~   "
117674|NCT02027259|"~     The purpose of this study is to determine whether group visits with added behavioral~     activation (BA) for depression will have a greater clinical impact than our standard group~     visits without BA for depression in reducing the risk of future coronary events as measured~     by the United Kingdom Prospective Diabetes Study (UKPDS) risk engine and depression symptoms~     as measured by Patient Health Questionnaire-9 (PHQ-9) after 6 months.~   "
117675|NCT02027246|"~     The aim of this study was to study the effect of stem cell therapy on common symptoms of~     spinal cord injury patients.~   "
117676|NCT02027233|"~     This study assesses the seasonal of influenza vaccine effectiveness in adults hospitalised~     with laboratory-confirmed influenza through a network of hospitals in France.~   "
117677|NCT02027220|"~     RATIONALE: Bortezomib may stop the growth of myeloma cells by blocking proteasome activity.~     Cyclophosphamide and dexamethasone may work in different ways to stop the growth of myeloma~     cells by stopping them from dividing or by killing the cells. Granulocyte Clone Stimulating~     Factor (G-CSF) possesses the ability to mobilize the plasma cells to detach from myeloma~     niche, so as to promote drug sensitivity.~      PURPOSE: This phase Ⅱ trial is to study how well combination of G-CSF, bortezomib,~     cyclophosphamide and dexamethasone works in treating patients with multiple myeloma.~   "
117678|NCT02027207|"~     Bangladesh remains endemic for cholera, which experiences biannual outbreaks with additional~     epidemics seen during times of floods, cyclones or any natural disaster. It affects all age~     groups with the majority of fatal cases occurring in children . Therefore, immunization~     against cholera remains an important public health component in the prevention and control of~     the disease .The current two-dose regimen of the internationally available oral cholera~     vaccines (OCV) create a logistical and programmatic challenge for use in national programs or~     during epidemics ,so it is important to determine if a single dose vaccine will be protective~     in regions where cholera is endemic. If the vaccine is found to be efficacious following a~     single dose, this will have profound implications for the use of the vaccine in areas with~     limited resources particularly in complex emergencies where a multiple dose regimen is~     difficult to deploy. A single-dose regimen of this vaccine will improve its 'field ability'~     and allow the vaccine to be used for outbreak control, especially in difficult settings where~     the risk of cholera is extremely high and provisions for clean water and sanitation are not~     available. With low OCV production rates, larger populations could be immunized against~     cholera if a single dose is found to be efficacious. A single-dose schedule could facilitate~     the inclusion of a global stockpile strategy.~      The study design is a two-arm individually randomized double-blind placebo-controlled trial.~     The primary outcome of the study is the proportion of persons receiving 1 dose of vaccine or~     placebo who are detected with diarrhea with faecal excretion of V. cholera O1 in the study~     treatment centres from 7 days to 6 months after dosage and whose identity is confirmed~     through home visit.~   "
117679|NCT02027194|"~     The aim of this study is to test and compare the effectiveness between three groups -~     Cure-Allergic Rhinitis Syrup (CS), Yuk ping fung San (YS) and placebo groups - of adolescents~     (nursing students) with Allergic Rhinitis (AR) in improving their symptoms of AR, body~     constitution pattern and health-related quality of life.~      • The hypothesis are to test the effectiveness of the CS treatment on these students' AR~     symptoms and quality of life at immediately, one month and two months after completion of the~     4-week intervention, when compared with the YS treatment and placebo group.~        1. Cure-Allergic Rhinitis Syrup (CS) group will show significantly reduction of AR symptoms~          over the 2-month follow-up, when compared to those in YS and placebo groups.~        2. CS group will indicate a healthier body constitution pattern over the follow-up, when~          compared to those with YS and placebo group.~        3. CS group will indicate significantly greater improvement of their quality of life over~          2-month follow-up, when compared to those with YS and placebo group.~   "
117680|NCT02027181|"~     Aim: The purpose of this study is to evaluate the use feasibility of FreeO2 so as to deliver~     automatically oxygen in the emergency department in a patient population admitted for acute~     respiratory failure.~      Hypothesis: The principal hypothesis is that FreeO2 is possible and well-accepted by nurses~     and medical personnel and there are advantages to use this system. In comparison with the~     common oxygen delivery (the rotameter), the hypothesis is that FreeO2 system will make for a~     better control of the oxygen saturation in function of designed target, reducing the~     desaturation time and hyperoxia. We think that oxygen weaning will be faster than classical~     way if it is automated. In addition, FreeO2 could reduce the number of intervention by nurse~     personnel.~   "
117681|NCT02027168|"~     This study will examine the impact of manual physical therapy on endocrine function in women~     diagnosed as being infertile due to elevated follicle stimulating hormone (FSH) levels (10~     mIU/mL or higher) on days 2-5 of their menstrual cycle. It is hypothesized that the manual~     physical therapy will decrease FSH levels.~   "
117682|NCT02027155|"~     This will be a randomized, double-blind, placebo-controlled, rising-dose study of single IV~     doses of AR09 in healthy subjects. Each infusion will occur over 10 minutes.~   "
117709|NCT02026804|"~     The purpose of this study is to find the incidence of mental disorders during different~     periods of pregnancy and its associated factors and consequences.~   "
117710|NCT02026791|"~     Since the laryngeal mask airway (LMA) was designed and introduced into a clinical setting, a~     supraglottic airway device is widely used because it has advantages such as manipulation of~     the device when inserting it is easier than that of an endotracheal tube and it causes less~     postoperative sore throats. Insertion of an LMA can be performed relatively easily and safety~     at an appropriate depth of anesthesia when compared with the insertion of an endotracheal~     tube because an LMA is inserted without using a laryngoscope and without causing stimulus to~     the vocal cords and the trachea. Hence, an LMA may be useful in cases of coronary artery~     disease and a carotid endarectomy where stabilization of the cardiopulmonary function is~     important. In addition, an LMA is hemodynamically stable not only in the induction of~     anesthesia but also in the arousal of anesthesia and thus less dangerous to a cardiovascular~     disease patient. LMA may be useful also to patients having chronic obstructive lung disease~     because the patients have an excessively sensitive airway and ventilation is difficult to~     perform in them. Therefore, in elderly patients having a prevalence for cardiovascular~     disease or chronic obstructive lung disease, use of an LMA, which stimulates the airway less,~     may provide hemodynamical stability and reduce relevant complications or side effects. LMA~     Supreme which is newly designed in such ways has been proven to be superior to the~     conventional LMA Classic in terms of easy insertion and oropharyngeal sealing. A study which~     compared LMA Classic and LMA Supreme with adult subjects showed that LMA Supreme had a~     superior insertion success rate and better oropharyngeal leak pressure (OLP) than those of~     LMA Classic. Another newly developed supraglottic airway device is I-gel. In I-gel, which is~     a disposable, latex-free LMA, a soft, gel-type cuff made of a thermoplastic elastomer~     replaces the inflatable cuff of other LMAs. Thus, I-gel has an advantage that, once it is~     installed, it requires no additional clinical manipulation such as cuff inflation or cuff~     pressure monitoring. A comparison of I-gel with LMA Classic and other disposable supraglottic~     airway devices produced by various manufactures in adult subjects showed that the clinical~     properties were similar with respect to easy insertion, time required for installation,~     laryngopharynx leak pressure, and degree of glottis exposure observed with a fiberoptic~     bronchoscope. Thus, I-gel is expected to be a supraglottic airway device which may replace~     the conventional LMA Classic. The elderly are known to have an upper airway anatomically~     different from that of younger adults depending on age. A study conducted with CT showed that~     normal elderly people had a wider upper airway than that of younger males or middle-aged~     males and that elderly with accompanying sleep apnea had a wider upper airway than that of~     younger males in all regions including the nasopharynx, oropharynx, and hypopharynx.~     Therefore, because the upper airway of the elderly is wider and longer, a different~     supraglottic airway device guide may be necessary. Our previous studies showed that the~     single time success rate was significantly lower, the insertion was more difficult, and the~     insertion took a longer time when the LMA classic was used in elderly patients than in~     younger adult patients. However, there is no available guide for the use of a supraglottic~     airway device or for a supraglottic airway device more appropriate for elderly patients.~     Moreover, no study has been ever conducted with regard to such a guide.~      Therefore, in this study, the clinical usefulness of I-gel and LMA Supreme, which are the~     newest supraglottic airway devices, was verified in elderly patients. It was also verified~     which of the two devices is better to use as a supraglottic airway device.~   "
117683|NCT02027142|"~     This study included women referred to two academic centres for the diagnosis and treatment of~     endometriosis (cases) and women referred to our Institutions because of routine gynaecologic~     consultations (controls). In this age-matched case-control study, the aimdy was to assess~     quality of sleep, the average daytime sleepiness and insomnia in patients with endometriosis~     by using three different self-reported questionnaires.~   "
117684|NCT02027129|"~     Recent data from large trials of high-frequency high frequency oscillation (HFO) without a~     cuff leak vs, lung-protective conventional ventialtion (CMV) failed to show any HFO-related~     benefit with respect to outcome. A possible explanation is that HFO increases the probability~     of right ventricular dysfunction due to the combination of high mean airway pressures (mPaws)~     and hypercapnia. In contrast, available preliminary data on low-frequency HFO-tracheal gas~     insufflation (TGI) with cuff leak vs. CMV are suggestive of an HFO-TGI related benefit.~     Low-frequency HFO-TGI with a cuff leak is associated with relatively low mean tracheal~     pressures and adequate control of PaCO2. Thus, the investigators intend to test the~     hypothesis that low frequency HFO +/- TGI with a cuff leak is associated with better right~     ventricular function relative to high-frequency HFO without a cuff leak.~   "
117685|NCT02027116|"~     To evaluate the safety, tolerability and immunogenicity of VGX-6150 as second-line therapy in~     chronic hepatitis C patients~   "
117686|NCT02027103|"~     Oral hypoglycemic agents, along with dietary modification and exercise encompass the mainstay~     of treatment in early stages of T2DM. Biguanides and thiazolidinediones are two major groups~     of hypoglycemic medications that while function via different pathways, mare both effective~     in short- and long-term glucose control. These medications diminish or delay long term micro-~     and macrovascular complications associated with T2DM although at different rates. Excessive~     insulin resistance accounts for a sustained increase in cardiovascular incidents in T2DM~     subjects. Given the shared pathway of insulin resistance/fetuin-A/OPG in atherosclerosis~     formation, it is conceivable that insulin sensitizing anti-diabetes medications are able to~     modify successive CAD risk via direct and indirect amelioration of insulin~     resistance/fetuin-A/OPG. The present study is therefore designed to investigate the effects~     of metformin and pioglitazone monotherapy on serum concentrations of fetuin-A and OPG in a~     group of Iranian adults with newly diagnosed T2DM.~   "
117687|NCT02027090|"~     We hypothesize that higher dose icotinib is related with better efficacy. The primary~     objective is to compare the progression-free survival of higher dose and routine dose of~     icotinib in treating pretreated advanced non-small cell lung cancer patients with stable~     disease after 8-week routine dose icotinib treatment.~   "
117688|NCT02027077|"~     Obesity is a major risk factor for disease and a public health problem. Recent information~     suggests that while it is possible for most overweight adults to lose a substantial amount of~     weight, maintaining the weight loss for any extended time (2 to 3 years) is very difficult.~     This is because trying to maintain big changes in exercise and/or eating behaviour is very~     difficult in today's environment that makes sustain big changes in behaviour (Example: eat~     allot less or exercise allot more) very hard. In fact at this time health professionals are~     unsure of how best to help overweight adults maintain big behavioral changes for long periods~     of time. In response, we propose that making smaller changes in eating and exercise habits~     every day may be possible in today's environment and if so, small weight changes may be~     possible to maintain for long periods of time. This study is designed to assess whether~     making small changes in eating and exercise behavior will be associated with sustained weight~     loss over three (3) years. The results of the study may have important implications for~     development of public health messages and clinical guidelines for prevention and treatment of~     obesity through small changes in both exercise and eating habits.~   "
117689|NCT02027064|"~     molecular relapse in t (8; 21) acute myeloid leukemia (AML) after allogeneic stem cell~     transplantation (allo-SCT) is still a problem even after donor lymphocyte infusion.~      Interferon seemed to augment graft-versus-leukemia (GVL) effect in this part of patients.~      the study is to evaluate the safety and efficacy of interferon for the intervention of~     molecular relapse in t (8; 21) acute myeloid leukemia (AML) after allogeneic stem cell~     transplantation (allo-SCT)~   "
117690|NCT02027051|"~     This study aims at better understanding the genetic structure of the Armenians, an old~     population whose genetics has not been the subject of many studies. We will study 500~     individuals whom grandparents originate from different regions of Armenia. Each individual~     will be genotyped using a large panel of genetic markers. Principal component analysis will~     be used to analyze the genetic structure of this population.~   "
117691|NCT02027038|"~     Hypothesis I: The anatomic alignment of the pelvic bones, the electromuscular activation of~     limb muscles and ground reaction forces are different in patients with sacroiliac joint pain,~     as compared to healthy controls.~      Hypothesis II: The application of pelvic belts alters the alignment of the pelvic bones, the~     electromuscular activation of the limb muscles or ground reaction forces.~      Hypothesis III: The effects proposed in hypothesis II are different in patients with~     sacroiliac joint pain, as compared to healthy controls.~   "
117692|NCT02027025|"~     Study of SPARC1103 in subjects wirth spasticity~   "
117693|NCT02027012|"~     REDUCE-HTN-China study is a prospective, multi-center, single cohort study for the~     percutaneous therapeutic treatment of medication-resistant hypertension in China.The primary~     objective is to assess the efficacy performance of the Vessix™ Renal Denervation System for~     the treatment of medication resistant hypertension on the basis of the hypothesis that the~     percutaneous therapeutic renal denervation for the treatment of medication-resistant~     hypertension using the Vessix™ Renal Denervation System will reduce systolic (SBP) and~     diastolic blood pressure (DBP) at 6- month compared to baseline as accessed by office-based~     blood pressure measurements.~   "
117694|NCT02026999|"~     The purpose of this study to determine the effectiveness of sugammadex in septoplasty~     patients whose mask ventilation would be difficult after extubation.~   "
117735|NCT02026466|"~     This is an observational registry, sponsored by Saint Luke's Hospital. This study is to be~     conducted according to DHHS Guidelines, applicable state regulations, and local IRB policies~     and procedures. The overall objective is to address current gaps in knowledge regarding~     CTO-PCI, as a prospective, multi-center, single-arm study of 1,000 participants.~   "
136512|NCT01780402|"~     The purpose of this study is to test three hand feeding techniques that can be used to~     provide feeding assistance to persons with dementia - direct hand feeding, hand-over-hand~     feeding, and hand-under-hand feeding.~   "
117695|NCT02026986|"~     Tear film consists of three layers including outer lipid layer, aqueous layer and inner mucin~     layer.1,2 Lipid layer protects the aqueous layer of tear film from evaporation and mucin~     layer adhere the tear film to ocular surface. Aqueous layer, which is produced in lacrimal~     glands, is the most important in the health of ocular surface. Reduction of aqueous tear~     secretion results in the disruption of homeostasis at ocular surface and leads to dry eye~     syndrome.2 Dry eye syndrome is a common ocular surface disease associated with symptoms of~     eye discomfort, grittness and visual disturbance.1,2 Dry eye syndrome disrupts normal~     homeostasis at the ocular surface resulting in epithelial damage, epithelial cell apoptosis,~     loss of goblet cells, and squamous metaplasia.1-3 The changes and inflammation of ocular~     surface subsequently lead to tear instability, which causes an increased tear osmolarity and~     aggravates the inflammatory cascades. This leads to a vicious cycle.2 The regulation of tear~     film secretion is under neural and hormonal control.4 Dry eye syndrome has been associated~     with diverse and multiple causes, including depressive disorder, drugs, hormonal status, and~     systemic diseases.2 Sleep deprivation (SD) is known to cause profound impair¬ments in~     executive function and vigilant attention.5,6 It is also reportedly associated with autonomic~     and endocrine functioning7-9 and has been shown to increase blood pressure and stress hormone~     levels and decrease parasympathetic tone.10,11 Tear secretion is regulated by neurological~     factors and hormones,12 and so SD may have an effect on the tear film and ocular surface.~     However, only a few studies have evaluated the effect of sleep on the tear film and ocular~     surface.~      In this study, we investigated the effect of SD on the tear film and ocular surface.~   "
117696|NCT02026973|"~     Endogenous estrogens maintain growth hormone (GH) secretion in postmenopausal women by~     potentiating endogenous GH-releasing hormone (GHRH) drive and restraining somatostatin~     inhibition of GH release.~   "
117697|NCT02026960|"~     The primary objective is to evaluate methods for AGS-003 production from surgical (stage I)~     and metastatic biopsy (stage II) Renal Cell Carcinoma (RCC) and a small subset of other GU~     cancers (expansion cohort) specimens using core needle biopsy in subjects with RCC or other~     GU cancers. Specifically, this study will evaluate the feasibility of RNA amplification from~     total tumor RNA isolated from tissues obtained by core needle tumor biopsy.~   "
117698|NCT02026947|"~     The aim of this study is to investigate whether sodium benzoate is superior to placebo in~     decreasing symptoms among patients with attenuated/transient psychosis. A total of 140~     patients will be randomized in 1:1 ratio to receive sodium benzoate 1 g/day or placebo for 12~     weeks. Concerning statistical power, the number of patients is sufficient to obtain~     statistical significance for a clinically meaningful effect size of 0.40 (Cohen's d). The~     primary outcome measure is change in PANSS sum score of delusions, hallucinations,~     suspiciousness and conceptual disorganization (the PANSS items that are inclusion criteria)~     at week 12. Change in CGI score at week 12 is the other primary outcome measure. The~     secondary outcome measures are change in PANSS total score at week 12, CGI score at week 24,~     and GAF at weeks 12 and 24.~   "
117699|NCT02026934|"~     CliniMACs is an investigational device used to select and enrich stem cells. The device will~     select the stem cells with CD34+ protein. The participant will be infused with the CD34+~     selected cells in the hopes that it will help the participant engraft. Engraftment is when~     transplanted stem cells resume production of healthy blood cells.~   "
117700|NCT02026921|"~     A phase II single arm study of carboplatin and docetaxel in treatment of first sensitive~     relapse of epithelial ovarian, peritoneal or tubal cancer.~      Hypothesis: Treatment with this combination in second line is safe and with a low frequency~     of neurologic side effect.~   "
117701|NCT02026908|"~     This is an open-labeled, non-randomized feasibility study to evaluate the safety of prostate~     artery embolization (PAE) for the treatment of lower urinary tract symptoms attributed to~     benign prostatic hyperplasia (BPH).~   "
117702|NCT02026895|"~     The main objective is to identify new virulence factors produced by Staphylococcus~     lugdunensis that can be associated with clinical sign of severe infections and identified~     symptoms. The methodological approach is based on the comparison between the production of~     toxins by a given S. lugdunensis isolate classified in patients groups according to the~     infection clinically defined. Each group will be compared to the presence or not of studied~     virulence factors. Clinical features associated with toxin activity are not known for S.~     lugdunensis. This comparative approach is based on the hypotheses that drove to the~     definition of patient groups and their clinical criteria. However, in the absence of the~     evident correlation between production of toxins and kind of infection, the statistical~     evaluation will be completed by a multi-varied analysis. This approach has not been choosen~     first because of the multiple parameters that undergo during infection that may reveal~     relationships without true correlation. About the number of included patients in each defined~     group, if one of them does not reach the expected count, we still might extend inclusions to~     3-6 months more. The presence of severe infections without usually defined risk is~     intriguing. For these last patients, we have planned, after their individual consent to~     achieve an exome sequencing. The obtained data will be compared to available resources for~     the human genome. By filtering data through usual protocols, we hope to able to focus onto~     few genes that evoke specific sensitivity to infections, e.g. severe endocarditis due to S.~     lugdunensis without defined risk.~   "
117703|NCT02026882|"~     The Supreme Laryngeal Mask Airway (SLMA) is a single use supraglottic device that provides a~     good seal for positive pressure ventilation and good first attempt insertion rate of 98% in~     low risk patients undergoing elective Caesarean section. It has a double aperture design that~     facilitates the introduction of an orogastric tube to aspirate gastric contents.~      The primary study hypothesis is the first attempt insertion success rate of SLMA use in~     urgent Caesarean section.~   "
117704|NCT02026869|"~     Polycystic ovary syndrome is a common cause of irregular periods, poor ovulation and delay in~     achieving pregnancy. Certain drugs may help improve ovarian activity in such women as~     metformin. Oral administration of metformin is accompanied by undesirable side effects. The~     vagina proved to be a good alternative to the oral route for other drugs. Using metformin~     through the vagina and avoidance of such side effects, while maintaining its effectiveness,~     would help women to better tolerate this drug.~   "
117705|NCT02026856|"~     This study looked at parenteral administration of selenium to septic patients and~     subsequently monitored dynamic changes of selected activities of antioxidant enzymes and the~     development of clinical status.~   "
117711|NCT02026778|"~     Many patients undergoing gynecologic laparoscopic surgery experience postoperative nausea and~     vomiting (PONV) despite prophylaxis and treatment with HT3 receptor antagonists such as~     ondansetron. Involvement of multiple types of receptors and factors may be a reason for~     inadequate control of PONV with a single agent. Betahistine, a histamine antagonist at H1~     receptor and antagonist at H3 receptor, is widely used as a treatment of dizziness. Dizziness~     is one of the cause of nausea and vomiting. This study is to compare the effects of~     ondansetron and combined ondansetron and betahistine in preventing PONV in high-risk patients~     receiving intravenous opioid-based patient-controlled analgesia (IV-PCA) after gynecological~     laparoscopic surgery.~   "
117712|NCT02026765|"~     The purpose of this study is to obverse the effect of this type lens in the same as~     traditional aspheric intraocular lens at the same time, whether can further improve the~     effects of operation.~   "
117713|NCT02026752|"~     The objective is to obtain plasma samples from Human Immunodeficiency Virus Type 1 (HIV-1)~     infected individuals that have viral loads across the dynamic range of the Aptima HIV-1~     assay. The plasma samples will be tested in a method comparison study to support the approval~     of the Aptima HIV-1 assay on Gen-Probe's Panther testing system. The objective of the method~     comparison study is to evaluate the clinical utility of the Aptima HIV-1 assay by comparing~     the results to the FDA-licensed COBAS assay (Roche Molecular Systems, Inc., Branchburg, New~     Jersey) in plasma samples that have viral loads across the dynamic range of the Aptima HIV-1~     assay.~   "
117714|NCT02026739|"~     The study hypothesized that a relative low oxygen concentration (40%) supplemental would be~     advantageous to protect the pulmonary function of patients, comparied with conventional high~     oxygen concentration (80%). Therefore we raise this prospective randomized controlled~     research.~   "
117715|NCT02026726|"~     The purpose of this observational study is to show whether a standard oral steroid dose pack~     can be used as a screening tool to assess the effectiveness of a subsequent epidural steroid~     injection (ESI). If an oral steroid does not give a patient significant temporary relief of~     pain from a herniated lumbar disc then an epidural steroid injection will not either.~     Therefore the risk and expense associated from the interventional pain management procedure~     for those patients could be avoided and other treatment modalities pursued.~   "
117716|NCT02026713|"~     All consecutive patients undergone PTCA in the period between July 2013 and December 2013 are~     eligible to be enrolled. Study population are divided in :~      Group 1: smokers on dual antiplatelet therapy with ASA (100 mg once a day) and Prasugrel (10~     mg die); Group 2: smokers on dual antiplatelet therapy with ASA(100 mg once a day) and~     Ticagrelor (90 mg twice a day); Control group: smokers on dual antiplatelet therapy with~     ASA(100 mg once a day) and Clopidogrel (75 mg once a day).~      Platelet function is evaluated using a validated method: the VerifyNow System (Accumetrics~     Inc., San Diego, CA), which is a point-of-care turbidimetry-based optical detection system~     that measures platelet-induced aggregation. These value are measured Platelet function,~     measured with the VerifyNow P2Y12. All patients on chronic dual antiplatelet therapy (>1~     month) quit smoking for a 2 weeks period. Therefore PRU values are obtained at baseline (at~     the enrollment time) and after 2 weeks after smoking cessation. Platelet reactivity are~     expressed in P2Y12 reaction units (PRU). PRU values >240 are suggestive of high platelet~     reactivity.~      Primary outcomes: P2Y12 reaction units (PRU) at baseline and two weeks after quitting~     smoking.~   "
117717|NCT02026700|"~     We intend to evaluate the efficiency and tolerability of a barrier cream (bariederm) in~     protecting hands of individuals with hand dermatitis, either due to allergy or irritation. We~     believe that the use of the cream would benefit with the skin.~   "
117718|NCT02026687|"~     The purpose of the study is to compare epidural analgesia and intrathecal analgesia for~     explorative laparotomy through a middle-line incision for gynecological cancer in a fast~     track program to se if there is any difference in recovery. Length of stay is analyzed~     together with self-rate quality of life.~   "
117719|NCT02026674|"~     The FloRite™ device is a disposable urine flow meter, indicated for use in a home setting.~      The device provides Urofowmetry measurements, similar to clinic's measurements. Clinic-based~     uroflowmetry has some flaws; the setting is artificial and often it is difficult to void at~     the desired moment. Moreover, a single measurement of the voided parameters is a poor~     representative of the patient condition due to high variability of the measured parameters.~     Performing multiple Urofowmetry measurements provides representative and more accurate~     results, in a more patient-friendly, cost effective method.~   "
117720|NCT02026661|"~     To determine the association of factors affecting the clinical pregnancy and live birth rates~     in patients undergoing in vitro fertilization (IVF) who received intracytoplasmic sperm~     injection (ICSI) and/or laser assisted hatching (LAH) or neither.~      After applying the inclusion and exclusion criteria, a total of 400 women who underwent IVF~     between January 2007 and December 2010 were included in the analysis. Patients were divided~     into 4 groups; 1) those that did not receive ICSI or LAH, 2) those that received ICSI only,~     3) those that received LAH only, and 4) those that received both ICSI and LAH. Univariate and~     multivariate analyses were performed.~   "
117721|NCT02026648|"~     Squamous cell carcinoma (SCC) of the cervix has showed a marked decline in developed~     countries over the past 40 years, however, there has also been an increase in relative and~     absolute incidence of adenocarcinoma and adenosquamous carcinoma (AC) of the uterine cervix~     over the same period.~      Our understanding of the natural history and optimal management of AC is limited. It appears~     that AC and SCC of the cervix behave differently. They are different in epidemiology,~     prognostic factors, and patterns of failure after similar treatments. Available data suggest~     that they may also differ in their response to treatment. We postulate that new treatment~     strategies specifically tailored to AC should be explored.~      However, there is few data about outcome of cervical cancer in Taiwan. So we propose this~     proposal for retrospective analysis of clinicopathological parameters and outcomes in~     patients of cervical cancer, especially for cervical adenocarcinoma and adenosquamous~     carcinoma.~   "
117722|NCT02026635|"~     A research study to determine if heart failure can be medically managed using data collected~     from cardiac monitoring devices~   "
117723|NCT02026622|"~     The main objective is to compare the physiological reactivity (heart and respiratory rates,~     galvanic skin response, cerebral perfusion, and startle) in the three phases of emotion~     between depressive subjects, subjects remitted from depression and control subjects.~   "
117724|NCT02026609|"~     Transjugular intrahepatic portosystemic shunt (TIPS) is the first-line therapy for patients~     with cirrhosis and refractory ascites. However, mental changes known as hepatic~     encephalopathy (HE) frequently occur after TIPS. There is no effective method to predict HE~     after TIPS. Oral glutamine challenge (OGC) and psychometric tests have been used to assess~     the risk for HE, but never in patients undergoing TIPS. Severe muscle loss may also~     predispose patients to HE. The aim of the present study is to assess if both the OGC and~     psychometric tests can accurately predict the development of overt HE after TIPS. Patients~     will be studied before TIPS and followed after TIPS for the development of HE. The role of~     muscle loss in favoring HE, as well as is possible reversibility after TIPS will also be~     investigated.~   "
117725|NCT02026596|"~     Subarachnoidal hemorrhage (SAH) is a cause of long-term disability and death. Annually about~     1000 people in Finland suffer from SAH, their average age being under 50 years. SAH has a~     mortality rate of 12 % acutely and 40 % of patients die within a month from admission to~     hospital. In addition, 30 % of the surviving patients remain with neurological deficits. Most~     survivors of the primary insult suffer from secondary injury during the first 2-3 weeks from~     the insult.~      Despite the advances in neurosurgical and -radiological techniques and intensive care, the~     mortality and morbidity rates in SAH have not changed in recent years. There is still only~     limited understanding of the mechanisms of secondary insults causing brain injury after SAH.~      In this study the investigators are aiming to clarify the timescale and mechanisms~     contributing to the secondary insults. The investigators also explore usability of novel~     biomarkers to guide treatment of the patients suffering from SAH.~   "
117726|NCT02026583|"~     1. Study Objectives 1) Primary Objective: Progression-free survival 2) Secondary~          Objectives:~             1. overall survival~             2. response rate~             3. incidence, nature and severity of all adverse events~             4. lipid lowering effect of simvastatin~             5. exploratory biomarker analysis : angiopoietin 2, BiP (Binding protein), Hsp (Heat~               shck protein) 90α~        2. Study hypothesis In our recent in vitro study, addition of simvastatin to bevacizumab~          reduced proliferation, migration, invasion and tumor formation of endothelial cell.~          Moreover, colorectal cancer cell media which was treated with simvastatin combined with~          bevacizumab inhibited endothelial cell invasion and it was associated with decreased~          mediator of angiogenesis, such as angiopoietin 2, BiP and HSP 90α.. Treatment with~          bevacizumab and simvastatin more reduced the growth of xenograft tumors compared with~          bevacizumab alone.~        3. Assessments 1) Safety : physical examination, vital signs, body weight, ECOG (Eastern~          Cooperative Oncology Group) performance status, clinical laboratory evaluation~          (chemistry, blood cell count) and any AE (adverse effect) graded by using CTCAE (Common~          Toxicity Criteria for Adverse Effects ) v 4.0 2) Efficacy : progression-free survival~          and overall survival will be collected. Response rate according to RECIST (Response~          Evaluation Criteria in Solid Tumors) 1,1 guideline will also be evaluated 3) PFS~          (Progression free survival): time from randomization to tumor progression or death 4) OS~          (Overall survival) : time from randomization to death or last follow-up 5) Biomarker~          analysis; The correlation between blood level, protein expression of angiopoietin 2,~          BiP, Hsp90α and clinical response will be explored.~   "
117727|NCT02026570|"~     Objectives: The purpose of this study is to investigate attentional (internal vs. external)~     focus effects on persons with amputation to perform a defined compensatory movement to reduce~     the likelihood of a fall. An internal focus of attention directs a person's conscious~     attention to their body's movements, whereas an external focus of attention directs a~     person's conscious attention to the effects of their movements or specific features in the~     environment. Numerous experiments have investigated the effects of an internal and external~     focus of attention on motor performance and the findings are in favor of an external focus of~     attention. In our work, we propose a motor learning research experiment to evaluate~     attentional focus strategies on the rehabilitation outcomes of learning and adaptation to the~     new proprioceptive information for persons with a recent transtibial amputation.~      Research Design and Methodology: For this pilot study, six participants with recent~     unilateral transtibial amputation will be recruited. Four participants will receive internal~     and external focus of attention training methods while the other two (control group) will~     receive standard prosthetic training instructions. The experiment will be conducted in three~     phases: Phase 1 -- Baseline Performance Test, Phase 2 -- Training sessions, and Phase 3 -~     Learning Test. The training will utilize a vibrotactile device designed to generate tactile~     sensations at the skin-socket interface simulating contact of the prosthesis with the~     environment. The sensation simulates a perturbation that signals a potential fall event.~     During the experiment the augmented sensory information will be introduced randomly while~     participants walk at a preferred pace on a level surface. Movement kinematics and kinetics of~     the body will be recorded for analyses using a motion capture system with force plates.~      Finding: It is hypothesized that the external focus of attention condition will outperform~     the internal focus of attention condition when responding to perturbations. The external~     focus of attention condition will yield faster response time and show improved compensatory~     responses compared to the internal focus of attention group by producing a greater lateral~     displacement of the artificial limb relative to the line of progression. In addition, the~     external condition will demonstrate a greater step length and step height than the internal~     focus of attention condition when provided with a perturbation.~      Clinical Significance: Current practices within the field of Physical Therapy reveal that~     there is little therapeutic intervention for fall prevention. Instructions are traditionally~     provided on how to reduce the risk of falling through preparation of a room or obstacle~     avoidance or on the proper way to fall to decrease injury. However, there are no protocols~     for providing a prosthetic user with compensatory strategies to avoid a fall after a~     perturbation occurs. The research findings can result in improved training protocols, which~     can improve rehabilitative outcome.~      Impact/Significance: The growing number of prosthetic users presents a need for improved~     patient care and effective prosthetic training and rehabilitation methods. Complimentary to~     the mission of the VA, the results of this research could enhance the quality of patient care~     and further assist these patients toward becoming prosthetically rehabilitated.~   "
117728|NCT02026557|"~     To describe mortality among children with congenital heart defects in Norway~   "
117729|NCT02026544|"~     The purpose of this study is to find out what effect, if any, Low Frequency Therapeutic~     Ultrasound (LOTUS) has on kidney function in patients with chronic kidney disease.~   "
117730|NCT02026531|"~     The diagnosis of a patient with pulmonary hypertension (PH) requires many investigations. At~     present cardiac catheterisation is the cornerstone investigation in these patients where it~     is used to establish disease severity and estimate prognosis. It is an invasive procedure~     which is expensive and not without risk to the patient. Despite the multitude of tests~     performed, identifying those patients with PH who have a poor diagnosis can be difficult. The~     aim of this study is to improve the assessment of patients with PH using novel magnetic~     resonance techniques.~   "
117731|NCT02026518|"~     Fasting blood specimens will be taken from the patients with IBS that have inclusion~     criteria. First, the objectives and method of study will be explained to the patients and~     informed consent form will be taken from them. They will be divided into 4 groups by an~     adjusted randomized blocking and the clinical outcomes, quality of life, emotional stress~     questionnaires will be completed before and after intervention. During 6 weeks, they will~     receive 2 capsules of soy isoflavones per day, 50000IU vitamin D biweekly in addition to the~     other placebo form, both of them and placebo of both. At the end, body mass index ( BMI),~     serum TNF-Alpha, TAC, gene expression of GATA3, ROR gamma, FOXP3 in lymphocytes and gut~     permeability will be measured. The quantity of polymorphisms of vitamin D and estrogen~     receptors will be determined.~   "
117732|NCT02026505|"~     The purpose of this study is to learn more about how a drug commonly used to treat multiple~     myeloma can affect the heart.~      In this study, the investigators will learn whether a drug called how a drug (called~     bortezomib, or Velcade) receive for multiple myeloma affects the heart. Bortezomib is part of~     the standard treatment and its effects on multiple myeloma is not being studied here.~      The investigators want to learn whether damage occurs to the heart after taking bortezomib~     for multiple myeloma, whether it is reversible, and we can predict damage to the heart before~     it occurs.~   "
117733|NCT02026492|"~     The purpose of this study is to compare the exercise-challenge in a cold chamber at 2-4°C to~     the gold standard the metacholine challenge in subjects showing symptoms of exercise-induced~     bronchoconstriction. The sensitivity and repeatability of the exercise test will be measured.~   "
117734|NCT02026479|"~     The incidence of sudden hearing loss is rising obviously resent year, Glucocorticoids have~     obtained obvious effect in the treatment of sudden deafness. Postauricular hypodermic~     injection is the latest findings in clinical work and a new noninvasive way of administration~     which is gradually expanding research. The aim of this experiment is to verify and explore~     the efficacy and safety of the postauricular injection treatment with different doses of~     Glucocorticoids.~   "
118710|NCT02013739|"~     The purpose of this study is to describe insulin resistance in a general chronic heart~     failure population, in combination with muscle strength, body composition and cardiac~     function.~      It is assumed that insulin resistance is increased in CHF patient, and that this is related~     to decreased muscle strength and decreased lean tissue mass.~   "
117736|NCT02026453|"~     We tested two interventions to improve the accuracy of medication histories obtained at~     hospital admission. The interventions target elderly and chronically ill patients prone to~     erroneous medication histories and resultant medication errors. For targeted patients, we~     tested the effect of using pharmacists and pharmacy technicians to obtain an initial~     medication history. This was studied using a randomized controlled trial of usual care (which~     involves nurses and physicians) vs usual care + pharmacists vs usual care + pharmacy~     technicians to obtain an admission medication history.~      The overarching hypothesis was that by leveraging pharmacists and pharmacy technicians we can~     minimize admission medication history errors and related downstream events.~   "
117737|NCT02026440|"~     The VioOne Oral Fluid Sample Collection Device can be used to collect human oral fluid~     samples for detection of cotinine using an ELISA cotinine assay.~   "
117738|NCT02026427|"~     The participants were hospitalized in Orthopedic and Traumatology Departments in Military~     Institute of Medicine, Warsaw, Poland.~      The inclusion criteria were (1) age to 40 year-old, (2) no history of urologic problems, and~     (3) surgery under spinal anesthesia. All the patients where (1) opioids were administered~     during the surgery, (2) general anesthesia was necessary, and (3) the urinary bladder~     catheterization was perform during the surgery were excluded from the study.~      The participants were randomly divided into the study and control groups. No oral~     premedication was administered. All the patients were asked to empty their urinary bladders~     before arrival to the operating theatre. When the standard monitoring (continuous~     electrocardiogram, noninvasive blood pressure, pulse oximetry) was started, intravenous~     premedication with midazolam was administered and lumbar spinal anesthesia with hyperbaric~     0.5% solution of bupivacaine hydrochloride was performed.~      In the study group, but not in the the control one, the 40 mg of drotaverine hydrochloride~     was administered intramuscularly. The decresed intravascular volume was corrected with~     cristalloids. During the surgery the adequate, not deeper than II grade according to Ramsay~     scale, level of sedationt was obtained with midazolam and/or propofol. All the participants~     received a questionaire in which we asked the questions about (1) the duration of anesthesia,~     (2) the time of micturition, (3) the time when discomfort or pain appeared in the lower~     abdomen, (4) the incidence of the urinary bladder catheterization and time to~     catheterization. On the next day after the surgery the questionaires were collected. In~     cases, when the patient's dischaged from the hospital was planned during the weekend, he or~     she was asked to pass on the questionaire to the nurses.~   "
117739|NCT02026414|"~     PrimaVie (Natreon Inc), is a a purified and standardized shilajit extract for nutraceutical~     use. Research indicates that PrimaVie® has targeted action for increasing energy,~     revitalization and anti-aging. Findings on a recent murine study revealed that PrimaVie (PV)~     significantly changed the expression of genes related to muscle function (unpublished data).~     Based on these facts, it was thought of interest to study the effect of PrimaVie and exercise~     training on human skeletal muscle adaptation.~      The objective of the study is to determine effect of PrimaVie supplementation and combined~     PrimaVie supplementation and exercise on changes in muscle gene expression related to muscle~     function. Two hypothesizes have been made, oral supplementation of PrimaVie twice a day for~     12 weeks will influence gene expression in the skeletal muscle of pre-obese to obese humans,~     oral supplementation of PV will act with treadmill exercise training to favorably impact~     skeletal muscle gene expression. The participants will have a total of 3 visits over 12~     weeks. During each visit will include measurement of height, weight and vital signs, 2~     tablespoons of blood will be draw from left or right arm, and muscle biopsies (using biopsy~     needle) will be collected under the use of local anesthetics. The blood and muscle biopsies~     will be used for all lab related procedure.~   "
117740|NCT02026401|"~     The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in~     patients with Primary Biliary Cirrhosis.~   "
117741|NCT02026388|"~     This study is being done to obtain samples from patients with primary hyperoxaluria,~     cystinuria, adenine phosphoribosyl transferase (APRT) deficiency, and Dent disease, and from~     their family members, for use in future research.~   "
117742|NCT02026362|"~     To prove that the efficacy and safety of 'MASCT group' is superior to 'non-treatment group'~     in patient undergone curative resection (RFA or operation) for hepatocellular carcinoma in~     China.~   "
117743|NCT02026349|"~     The purpose of this study is to determine if favipiravir is effective in reducing the time to~     resolution of influenza symptoms.~   "
117744|NCT02026336|"~     Patients with persistent asthma have different inflammatory phenotypes. The electronic nose~     is a new technology capable of distinguishing volatile organic compound breath-prints in~     exhaled breath among different pulmonary diseases.~      Question of the study. Is the electronic nose breath-print analysis able to discriminate~     among different inflammatory asthma phenotypes?~   "
117745|NCT02026323|"~     Hyperinsulinemia and insulin resistance play a key role in the pathogenesis of polycystic~     ovary syndrome (PCOS). Insulin resistance is significantly associated with the long-term~     risks of metabolic syndrome and cardiovascular disease. Acupuncture with electrical~     stimulation has in rats with dihydrotestosterone (DHT)-induced PCOS been shown to improve~     insulin sensitivity. Whether these findings can be translated into women with PCOS has not~     been investigated. Therefore, this study aims to evaluate whether acupuncture improves~     insulin sensitivity, ovulation rate and quality of life in women with PCOS. Our hypothesis is~     that acupuncture with combined manual and low-frequency electrical stimulation of the needles~     improves insulin resistance, induces ovulation and improves quality of life.~   "
117746|NCT02026310|"~     All the guidelines suggest that metformin as the basis of type 2 diabetes medication, and~     evidence is sufficient.At the same time the basal insulin injection once a day are more and~     more widely used in diabetes patients in China.~      This study aims to evaluate the efficacy and safety of adding glimepiride to type 2 diabetes~     patients with inadequate glycemic control with combined therapy of metformin and basal~     insulin.~   "
117797|NCT02025647|"~     Innerview can address some of the challenges of integrating mental health and primary care by~     accurately and reliably collecting mental health evidence and activities directly from~     patients, and then organizing and automating that evidence and activity into reports for~     providers and care teams that support diagnosis, treatment planning and monitoring of the~     mental health issues within a practice population.~   "
117747|NCT02026297|"~     The aim of this study is to characterize the coagulation changes, using thromboelastography~     (TEG), after prophylactic tranexamic administration during cesarean delivery. Specifically,~     TEG values will be compared in patients who receive prophylactic tranexamic acid or placebo~     before surgery, during elective cesarean delivery, and 2 hours postpartum.~      Postpartum hemorrhage (PPH) is increasing in incidence in the United States, renewing~     interest in multimodal approaches to blood conservation during cesarean delivery.~     Pharmacologic therapy with the antifibrinolytic agent, tranexamic acid (TA), has been shown~     to reduce estimated blood loss (EBL) during cesarean delivery, but its effect on global~     coagulation as assessed by TEG, and how this correlates with lowering blood loss, has not~     been elucidated.~      This study will be conducted as a randomized, double-blind, controlled trial with two study~     arms: control (60 patients); and treatment (60 patients).~      Subjects will be pre-medicated with routine pre-cesarean delivery medications including oral~     sodium citrate 30 mL and intravenous (IV) metoclopramide 10 mg. A peripheral IV and~     noninvasive hemoglobin monitor will be placed, and baseline labs sent: type and screen, serum~     hemoglobin, platelet count, fibrinogen, activated partial thromboplastin time (aPTT),~     prothrombin time (PT), and baseline TEG values (r time, k time, alpha angle, and maximum~     amplitude). Patients will have blood pressure, heart rate, and pulse oximetry measured~     throughout surgery as per standard of care. Patients will all receive IV lactated Ringers'~     (LR) solution prior to surgery and throughout surgery, with volume recorded and a goal of~     less than 2 L unless more IV fluid is clinically indicated. All patients will have a spinal~     anesthetic as per standard of care, with hyperbaric bupivacaine 12 mg, fentanyl 10 μg, and~     hydromorphone 100 μg. If the anesthetic plan is altered (combined spinal-epidural, general~     anesthesia conversion, general anesthesia planned), indications and medication doses used~     will be noted for analysis.~      Immediately following induction of anesthesia and prior to skin incision, infusion of study~     solution will be initiated.~      Study solutions will consist of:~        1. Control group: 100 mL 0.9% normal saline (NS).~        2. Treatment group: 100 mL 0.9% NS containing 1g tranexamic acid (TA). Study solution will~          be infused via an infusion pump over 10 minutes. Blood loss will be measured by visual~          estimate and weight of surgical sponges. Noninvasive hemoglobin will be measured~          throughout the study. All routine care lab values will be noted. At minimum, one lab~          panel will be sent one hour after study solution initiation (hemoglobin, fibrinogen,~          platelet count, aPTT, PT, and TEG).~   "
117748|NCT02026284|"~     The investigators aim to evaluate the preferences for anaesthesia methods of gravid women who~     are to deliver baby by caesarean section, the rates of general anaesthesia and regional~     anaesthesia, the reasons for preferences of general anaesthesia and regional anaesthesia and~     the factors affecting these preferences.~      A questionnaire consisting of 20 questions were applied to gravid women applying for delivery~     by elective caesarean operation, at Ankara University Faculty of Medicine Hospital for~     Gynaecology and Obstetrics between February 2010 and February 2011, in order to study the~     anaesthesia technique the patients prefer and the reason behind their preferences. Those~     gravid women who accepted to take part in the study were provided information about the~     questionnaire and their oral and written approvals were obtained.~   "
117749|NCT02026271|"~     This research study involves an investigational product: Ad-RTS-hIL-12 given with veledimex~     for production of human IL-12. IL-12 is a protein that can improve the body's natural~     response to disease by enhancing the ability of the immune system to kill tumor cells and may~     interfere with blood flow to the tumor.~      The main purpose of this study is to evaluate the safety and tolerability of a single tumor~     injection of Ad-RTS-hIL-12 given with oral veledimex.~   "
117750|NCT02026258|"~     The aim of this study is to evaluate the hypothesis that a piezotome-corticision procedure~     will have a transient acceleratory effect on the rate of tooth alignment and the overall~     treatment time. In addition, the subjects in the piezotome-corticision orthodontics group~     will experience a different level of pain, comfort, and satisfaction as opposed to the~     conventional orthodontics group.~   "
117751|NCT02026245|"~     In this study we will compare two electronic goniometric gloves to see if they can be used in~     research on joint movement in arthritis.~      One of the gloves we will use is the commercially available '5DT Ultra 14 glove', the other~     is a glove that we have specially designed and developed for use in people with arthritis.~     Both gloves are 'high-end' gloves with sensors for all of the finger and thumb joints.~      We aim to find out if the gloves are accurate and if they can be worn and used without too~     much discomfort by people with arthritis.~   "
117752|NCT02026232|"~     The basic plan of the study is to randomize otherwise healthy subjects with type 2 diabetes~     to hydroxychloroquine, 200 mg twice daily or placebo.~   "
117753|NCT02026219|"~     Ticagrelor is a non-thienophyridine, direct P2Y12 blocker that is more potent than~     clopidogrel and is associated with less interindividual variability. In the PLATO trial, it~     was found to be superior to clopidogrel with respect to cardiovascular outcomes and total~     mortality without increasing the risk of bleedings.~      More potent and reversible receptor bindings are possible explanation for the superior~     outcomes. Beside the potent effect on inhibition of antiplatelet function, ticagrelor has~     previously been demonstrated to increase adenosine levels by inhibiting adenosine re-uptake~     in tissue level and can induce adenosine triphosphate (ATP) release from human red cells,~     which both stimulate vasodilation of in red blood cells.~   "
117754|NCT02026206|"~     The purpose of this study was to evaluate the effectiveness of a self-therapeutic approach of~     skin adhesive low-level light therapy (LLLT) in females with primary dysmenorrhea (PD).~   "
117755|NCT02026193|"~     The chances to achieve pregnancy after retrieving >15 oocytes are not good, probably because~     of bad effect on the endometrium (uterine inner lining). Therefore, in most such cases the~     investigators prefer to freeze all embryos, and transfer in a thaw cycle. With the~     introduction of oocyte vitrification (very fast cooling) technology, a new option emerged: to~     freeze un-fertilized eggs, to be fertilized and used later in a thaw cycle.~      The purpose of this study is to compare the outcome of these two approaches.~   "
117767|NCT02026037|"~     The investigators propose to develop and pilot-test a short-term cognitive-behavioral~     treatment (CBT) for hospitalized survivors of acute burns, in order to reduce posttraumatic~     symptoms before they consolidate into long-term posttraumatic stress disorder (PTSD). This is~     important because approximately one third of burn survivors develop PTSD after discharge.~     PTSD is associated with extended psychological suffering and a greater need for medical~     services in the future. Although there are treatments for chronic PTSD, there are far fewer~     interventions available to treat acute posttraumatic symptoms before they develop into this~     disorder, and none to date has focused on adult burn survivors. The little research available~     on other forms of trauma suggests that interventions developed to treat PTSD may be helpful~     in preventing PTSD when used in the first weeks following a trauma.~      The investigators will develop a six-session intervention package for use with patients at~     the Los Angeles County + University of Southern California Burn Center. The intervention will~     translate CBT principles that have been validated with trauma survivors, but will be adapted~     to hospitalized burn patients. After manual development, we will pilot-test this treatment on~     15 patients who are medically stable, and not critically ill, intubated, or delirious.~     Treatment will consist of three 50-minute CBT sessions per week, involving~     mindfulness-focused relaxation training, graduated exposure to memories of the burn,~     psychoeducation, and cognitive restructuring. Assessment will include standardized tests of~     posttraumatic stress, anxiety, and depression, administered at the initiation and termination~     of treatment, and at one-month follow-up. Also assessed will be number of hospital days to~     discharge and participant satisfaction with treatment. We will evaluate the overall~     feasibility of conducting a study on PTSD prevention in burn survivors, as measured by~     initial recruitment success, subsequent dropout rates at the end of treatment and at the~     one-month follow-up, and participant satisfaction. These data will then be used to support a~     subsequent application for funding of a larger-scale randomized clinical trial (RCT) study.~   "
117756|NCT02026180|"~     Vascular access complications can occur during or after cardiac or peripheral arterial~     catheterization. These complications increase patient morbidity and mortality, as well as~     healthcare costs. Several strategies and devices have been employed to decrease the risk for~     vascular access complications, such as fluoroscopy-guided access, ultrasound-guided access~     and vascular closure devices. Randomized trial data has failed to demonstrate that~     fluoroscopic guidance reduces common femoral artery access complications. While meta-analysis~     data has demonstrated that vascular closure devices decrease time to arterial hemostasis,~     increase patient mobilization and facilitate earlier patient discharge, they do not reduce~     the incidence of vascular complications as compared to hemostasis achieved with manual~     pressure. Ultrasound guidance has been shown to facilitate femoral artery access and reduce~     femoral artery vascular complications. A new device, the Micropuncture Kit (Cook Medical,~     Bloomington, IN) allows vascular access with a small 21gauge needle as opposed to the~     standard method, which requires an 18 gauge needle. The use of the Micropuncture Kit for the~     purpose of decreasing vascular access complications has not been examined in a randomized~     study to date.~      The present study is a 552 patient randomized controlled clinical trial that will help~     determine whether femoral arterial access obtained using the Micropuncture Kit will reduce~     the incidence of vascular access complications compared to the standard 18 gauge needle.~      The specific aim of this proposal is to compare the rate of femoral artery access~     complications using the Micropuncture Kit vs. standard femoral artery access.~      It is our hypothesis that the incidence of femoral artery access complications will be lower~     among patients in whom the Micropuncture Kit is used.~   "
117757|NCT02026167|"~     The objective of this study is to test the effectiveness of a collaborative care approach to~     improving outpatient treatment for inactivity, chronic pain and depression as a way of~     improving overall Quality of Life for patients with SCI.~   "
117758|NCT02026154|"~     The study objective is to clarify the grounds of heart exertional dyspnoea stenocardia in~     patients with well-controlled stage I or II hypertension according to European Society of~     Hypertension, without changes in epicardial coronary arteries in CT coronary angiography and~     normal resting echocardiography result, and to assess of potential early markers of heart~     hypertrophy and failure in patients with hypertension.~   "
117759|NCT02026141|"~     Dexmedetomidine has been often used for procedural sedation. It has also has been shown to~     have a pain sparing effect. Therefore the investigators propose that if Dexmedetomidine is~     used for sedation in total knee replacements done under spinal anesthetic, the patients will~     have less pain up to 24 hours after the procedure.~   "
117760|NCT02026128|"~     Optical Coherence Tomography (OCT) machines are non-contact instruments that can provide~     micrometer (one one-thousandths) scale imaging of biological tissue. This allows excellent~     assessment of the white blood and inflammatory cells seen in uveitis, an inflammation of any~     or all parts of the uvea (iris, ciliary body, choroid).~   "
117761|NCT02026115|"~     The study purpose is to compare usual hospice care and PAINRelieveIt groups for effects on:~     (1) patient outcomes (analgesic adherence; worst pain intensity, satisfaction, and~     misconceptions) and lay caregiver outcome (pain misconceptions) in a diverse sample of 250~     cancer patient-caregiver dyads receiving hospice care; and (2) nurse outcomes (obtained~     appropriate analgesics for patient) in a sample of hospice nurses. The investigators~     hypothesize that at posttest, controlling for pretest data and compared to the usual care~     group, the PAINRelieveIt group will: a) report decreased scores for worst pain intensity and~     pain misconceptions; b) have increased analgesic adherence (primary outcome); and c) have a~     larger proportion who report satisfaction with pain intensity and whose nurses obtained~     appropriate analgesics for the patients' pain.~   "
117762|NCT02026102|"~     The purpose of this study is to test the acceptability and feasibility of a toolkit of~     patient decision aids (PtDAs) for heart failure patients who are considering an ICD implant.~   "
117763|NCT02026089|"~     The purpose of the study is to learn more abou how the immune system responds to the~     chickenpox vaccine in adults who had never had chickenpox as a child and were then vaccinated~     as an adult. The study aims to learn more about the strength and duration of the protection~     provided by the vaccine in adults, and to observe the immune response to an additional dose~     of chickenpox vaccine in adults who had received the vaccine at least 5 years earlier. This~     is especially relevant to workers in a hospital who may be exposed to chickenpox.~   "
117764|NCT02026076|"~     This study will seek to determine if 1) the manual unloading test is reliable, and 2)if the~     immediate response to traction can be determined by using a simple unloading test in~     standing. The study wil be completed in two parts: 1) a small pilot sample (n=10) to asses~     both intra and inter tester reliability, and 2) a consecutive sample of 30 patients with low~     back pain which does not travel below the knee. All subjects will rate their pain on a 100 mm~     line both at rest and in their most painful direction of movement. A therapist will then~     unload the patients spine to determine if they feel any relief. All subjects will then~     undergo a 15 minute bout of intermittent lumbar traction, 30 sec on, 10 sec off at up to 50%~     body weight. Following traction, all subjects will again rate their pain on a 100 mm line.~     Subjects will be grouped by response to the initial manual unloading test and assessed for~     within and between group differences. The study hypothesis is that the manual unloading test~     is reliable, and that responders to mechanical traction can be accurately identified using a~     manual unloading test.~   "
117765|NCT02026063|"~     The primary objective of this study is to evaluate the long-term safety and tolerability of~     orally administered telotristat etiprate.~   "
117766|NCT02026050|"~     the aim of this study was to investigate the analgesic efficacy of intra articular~     dexamethasone administration for arthroscopic shoulder surgery.~   "
117768|NCT02026024|"~     Type 2 diabetes patients have been proved to have decreased of glucagon-like peptide-1~     (GLP-1) levels. Incretin based therapy is associated with improved glycemic control by~     boosting GLP-1 levels . Nevertheless, the clinical effects are in great diversity for poorly~     controlled Type 2 diabetes patients. This study is designed to understand the pharmacological~     effects and genetic variation of incretin based therapy on type 2 diabetes.~   "
117769|NCT02026011|"~     This study will elucidate the pharmacogenetic effects of the Asn40Asp SNP of the OPRM1 gene~     on biobehavioral and neural markers of response to naltrexone in individuals of East Asian~     descent, an ethnic group most likely to express the positive predictive allele.~   "
117773|NCT02025959|"~     Getting better sleep in the hospital is especially important due to a variety of adverse~     health effects that can potentially worsen patient recovery.~      To address these concerns and improve sleep in US hospitals, we aim to develop the SIESTA~     (Sleep for Inpatients: Empowering Staff to Act) program as an educational intervention~     designed to prepare hospital staff to assist patients in obtaining better sleep in hospitals~     and recognize the importance of screening for sleep disorders. The major educational goals of~     this proposal is to develop and pilot test an online educational program (SIESTA) which aims~     to train and motivate medical professionals to provide better sleep for hospitalized~     patients.~      We will utilize data from an ongoing sleep study, performed by the research team at the~     University of Chicago that looks at how adult patients are able to sleep while they are in~     the hospital, as a means of education for the participating medical staff.~   "
117774|NCT02025946|"~     In case of severe ankle arthritis, the two common surgical treatments are tibiotalar~     arthrodesis and total ankle arthroplasty. Few studies have compared these treatments and it~     remains difficult to determine which operation is the better solution for end stage ankle~     arthritis.~      The purpose of the present study is to analyze patient's outcome after each type of ankle~     surgery and to describe the decision making process.~   "
117775|NCT02025933|"~     It has previously been seen that increased fish intake improves the metabolic health of~     overweight and obese adults, and animal protein improved metabolic health of obese rats. In~     this project the investigators will investigate whether increased intake of fish or meat~     improve metabolic health in children aged 9-12 years as well when replacing processed food.~     The hypothesis is that increased intake of unprocessed fish or meat will improve metabolic~     health in children as measured by glucose tolerance, lipid metabolism and inflammatory~     markers.~   "
117776|NCT02025920|"~     It has previously been observed that increased fish intake improves the metabolic health of~     overweight and obese adults, and animal protein improved metabolic health of obese rats. In~     this project the investigators will investigate whether increased intake of fish or meat~     improves metabolic health in overweight/obese adults aged 20-55 years when replacing~     processed food. The hypothesis is that increased intake of unprocessed fish or meat will~     improve metabolic health in adults as measured by glucose tolerance, lipid metabolism and~     inflammatory markers.~   "
117777|NCT02025907|"~     The purpose of this study is to assess the effect of canagliflozin (JNJ-28431754) compared to~     placebo in the treatment of participants with Type 2 Diabetes Mellitus (T2DM), who have~     inadequate glycemic control on maximally or near-maximally effective doses of metformin and~     sitagliptin.~   "
117778|NCT02025894|"~     The purpose of this study is to identify risk factors for thromboembolic and /or infectious~     complications in 3,000 patients with solid tumor and receiving a Percutaneous Central Venous~     Catheter (PCVC). A better understanding of the risk factors for these complications in this~     population would then allow interventional studies to be proposed to assess the benefit of~     prophylactic procedures in a sub-group of patients at most risk.~   "
117779|NCT02025881|"~     The trial includes i) the evaluation of the efficacy of a treatment strategy, designed as a~     phase II trial, and ii) a dose-finding part.~      The Phase II trial is an open label, non-randomized, multicentre trial without control group.~     A Bayesian approach will be used to analyse the EFS, assuming a cure model. We will use three~     prior distributions of the EFS; (1) an enthusiastic prior distribution, (2) a pessimistic~     prior distribution, and (3) a non-informative prior distribution. As the patient outcomes in~     the trial will be recorded, the subsequent distribution of the outcome probability under~     experimental treatment will be computed by applying Bayes' theorem, which yields an estimated~     EFS probability with a 95% credibility interval (measure of Bayesian precision). Two interim~     analyses are planned to monitor the efficacy data (early stopping rules for futility or~     inefficacy).~      The final analysis of efficacy will be made on an intention to treat basis, including all~     recruited patients, 3 years after recruitment of the last patient.~      Due to the uncertainty on the dose of cyclophosphamide that can be given in combination with~     Busilvex for the last chemotherapy course in patients in complete response after~     intensification chemotherapy treatment, a dose-finding subtrial will be performed to address~     this issue (Phase I part). The dose escalation of cyclophosphamide will be performed using~     the Continual Reassessment Method in a Bayesian framework.~   "
117780|NCT02025868|"~     Thilao is a multi-country, phase 2b, non-randomized study, in Burkina Faso, Cote d'Ivoire,~     Mali and Senegal, West Africa.~      HIV-1 adults with 2nd-line ART virologic failure (plasma HIV-1 RNA >1000 copies/ml) will be~     recruited and followed in two phases:~        -  First, a 12-week intentive adherence reinforcement phase, during which patients will~          continue 2nd-line ART, be seen repeatidly for counseling and educational training on~          adherence, and be offered the possibility of phone, SMS and home visit contacts with~          social workers;~        -  Second, a 48-week phase, during which:~             -  Patients successfully resuppressed at the end of the first phase will continue~               2nd-line ART and adherence reinforcement;~             -  Patients with persitent virologic failure will switch to a darunavir/r +~               raltegravir-based 3rd-line ART.~      Genotype resistance tests will be performed retrospectively on frozen samples. The main~     outcome will be the percentage of patients with plasma HIV-1 viral RNA <50 copies/ml at 64~     weeks.~   "
117796|NCT02025660|"~     Study Hypothesis Enhancement of Th-1 response with the help of a poly TLR agonist (Mw) is~     likely to increase survival in patients with severe sepsis.~      Objectives To study whether immunomodulation with Mycobacterium Mw helps in improving~     survival and the recovery of organ function in patients with severe sepsis. This will be~     assessed with the help of the following~        -  Mortality in the two arms~        -  Daily SOFA scores~        -  Ventilator free days~        -  Time-to-vasopressor withdrawal~        -  ICU length of stay~        -  Hospital length of stay METHODS This will be a proof of the concept study to assess the~          effect of Mycobacterium w in combination with standard therapy versus standard therapy~          alone on the inflammatory profile in sepsis due to gram negative infection. A total of~          25 patients will be enrolled in each group. The patients will be randomized in balance~          to receive either test drug or its placebo along with the standard of care~   "
117834|NCT02025166|"~     To compare between the efficacy of Paracetamol IV vs. Lornoxicam IV in pain relief following~     surgical abortion.~      The medication will be given at the time of the procedure. Following the abortion, pain level~     will be evaluated.~   "
117781|NCT02025855|"~     The purpose of this study is to determine if administering methadone to mechanically~     ventilated patients in the medical intensive care unit (ICU) requiring continuous infusions~     of sedatives and analgesics will decrease the time of mechanical ventilation, when initiated~     within 48 hours of their admission. Patients meeting enrollment criteria will be randomly~     assigned to receive methadone or placebo in addition to standard care. Methadone is a long~     acting pain medication that is approved by the Food and Drug Administration (FDA) to manage~     withdrawal from opioids and moderate to severe pain. Both of these indications are a frequent~     concern for critically ill patients that require mechanical ventilation. These patients often~     require intravenous (IV) opioids to manage the pain they experience due to their illness,~     procedures, and mechanical ventilation. During this time patients can develop physical~     dependence, which leads to withdrawal symptoms when the opioids are stopped or the dose is~     reduced. These symptoms can include agitation, pain, diarrhea and several others. Currently~     this is managed by a slow reduction in the dose of the IV opioid, but this can lead to~     prolonged time on mechanical ventilation, which has been associated with increased morbidity.~     Administering oral methadone to patients experiencing withdrawal symptoms has been shown to~     reduce and even eliminate these symptoms in the outpatient setting. This should also benefit~     patients in the ICU experiencing withdrawal from intravenous opioids required during their~     stay. It may allow for the other opioids to be discontinued more quickly, allowing for a~     shorter duration of mechanical ventilation.~      The level of pain and sedation will be assessed between groups randomized to either methadone~     or placebo in addition to current intravenous sedative and analgesic agents. The duration of~     mechanical ventilation will be assessed between both groups. Opioid withdrawal symptoms may~     manifest or be mistaken for delirium symptoms. ICU delirium is often managed with~     antipsychotic medications. To assess if methadone can reduce the need for antipsychotic~     medication, all administered antipsychotic doses will be recorded and total consumption will~     be compared between the two groups. Methadone has been associated with abnormal heart rhythms~     in rare instances. To ensure patient safety, data from the heart monitor will be collected~     and compared between the two groups to assess for QT interval prolongation.~   "
117782|NCT02025842|"~     To evaluate the impact of liver fibrosis and other variables [e.g., age, sex, virological~     response (VR), and previous resistance to nucleoside/nucleotide analogue (NUC) therapy] on~     Hepatocellular carcinoma incidence in an Italian population of genotype D HBeAg-negative CHB~     patients treated with long-term NUC therapy.~   "
117783|NCT02025829|"~     The purpose of this study is to determine whether IL-17 polymorphonuclear leukocytes (PMNs)~     are central to the disease pathology in CF. This will be determined by demonstrating that~     IL-17 PMNs are present in the CF airway, correlate with lung function measures, and decrease~     in patients being treated with IV antibiotics for a pulmonary exacerbation.~   "
117784|NCT02025816|"~     Hypothesis: We hypothesize that RNAseq will allow us to learn more about the causative agents~     of necrotizing soft tissue infections (NSTI) and risk factors involved in acquiring these~     devastating infections~      Tissue biopsies will be obtained from consented patients admitted with NSTI. Biopsies will be~     used for standard clinical analysis of bacterial species present or stored for later RNA~     sequencing. RNA sequencing will identify bacteria that are present within the infection site~     that may not be detected using standard culture techniques as well as reveal bacterial gene~     expression profiles within the NSTI site. Medical charts will also be reviewed for basic~     patient information as well as wound care management practices. We hope to identify bacterial~     species commonly present in these types of infections as well as risk factors predisposing~     individuals to NSTI's.~   "
117785|NCT02025803|"~     The purpose of this exploratory study is to investigate the safety and determine the maximum~     tolerated dose (MTD) of TAS-114 in combination with capecitabine in patients with advanced~     solid tumors for which the patients have no available therapy likely to convey clinical~     benefit.~   "
117786|NCT02025790|"~     The aim of this study is to compare efficacy of POEM and pneumatic dilatation in treatment of~     achalasia cardia.~   "
117787|NCT02025777|"~     Study Hypothesis UC Disease affects the colon. PillCam IBD may be used for visualization of~     the colon mucosa in UC Disease patients. This study is designed to evaluate the yield and~     clinical impact of IBD capsule in detecting lesions associated with UC Disease and to~     determine the agreement between PillCam Platform with the IBD capsule and optical colonoscopy~     in the evaluation of UC disease extent.~      Primary Scientific Objective To evaluate the agreement between PillCam IBD system and optical~     colonoscopy in the evaluation of UC disease extent (Non-active disease, Proctitis, Left-sided~     colitis, Pancolitis)~      Proposed Design Established UC disease patients whose clinical condition suggests ongoing~     disease activity, aged 18 years and up, who have no evidence of symptomatic stricture or~     other obstruction that would prevent capsule passage will be enrolled in this study.~      Patients will undergo bowel prep, followed by a PillCam IBD capsule examination and~     colonoscopy examination.~      The Rapid videos will be evaluated by two readers, each from a different site, the~     colonoscopy videos will be evaluated by two other physicians, at the sites~      INCLUSION CRITERIA~      All subjects must fulfill all of the following inclusion criteria:~        -  Patients ages 18 years and up~        -  Patient has known UC according to physician discretion~        -  Patient has at least one positive inflammatory marker from the following:~             -  ESR~             -  CRP~             -  CBC~        -  Patient is indicated and eligible for a standard of care colonoscopy examination~        -  Patient agrees to sign consent form~      EXCLUSION CRITERIA~      The presence of any of the following will exclude a patient from study enrollment:~        -  Crohn's Disease~        -  Antibiotic Associated Colitis~        -  Stool positive for O&P (C&S within 3 months of enrollment)~        -  Other known infectious cause of increased symptoms~        -  Known intestinal obstruction or current obstructive symptoms, such as severe abdominal~          pain with accompanying nausea or vomiting.~        -  Definite long stricture seen on radiological exam.~        -  Non-steroidal anti-inflammatory drugs including Aspirin, (twice weekly or more) during~          the 4 weeks preceding enrollment~        -  Suspected GI stricture, followed by patency capsule study or other imaging study that~          could not prove patency of the GI tract.~        -  Patient has had prior abdominal surgery of the gastrointestinal tract in the last 6~          months, other than uncomplicated procedures that would be unlikely to lead to bowel~          obstruction based on the clinical judgment of the investigator.~        -  Patient is expected to undergo MRI examination within 7 days after ingestion of the~          capsule.~        -  Patient with known gastrointestinal motility disorders.~        -  Subjects with known or suspected delayed gastric emptying~        -  Patient suffers from any condition, such as swallowing problems, which precludes~          compliance with study and/or device instructions.~        -  Patient has Type 1 or Type II Diabetes.~        -  Patient has any allergy or other known contraindication to the medications used in the~          study.~        -  Patient has any condition, which precludes compliance with study and/or device~          instructions.~        -  Women who are either pregnant or nursing at the time of screening, or are of~          child-bearing potential and do not practice medically acceptable methods of~          contraception.~        -  Concurrent participation in another clinical trial using any investigational drug or~          device.~        -  Patient suffers from a life threatening condition~        -  Patients with history or clinical evidence of renal disease and/or previous clinically~          significant laboratory abnormalities of renal function parameters.~   "
117788|NCT02025764|"~     The prophylactic APC right after colonic EMR doesn't mean the complete coagulation of visible~     vessel because of injection material.~      The aim of this study was to evaluate the clinical feature of the visible vessels in ulcer~     base over time after prophylactic APC in colonic EMR.~   "
117789|NCT02025751|"~     The purpose of this study is evaluate the safety and efficacy of Metoclopramide Nasal Spray~     compared to placebo in reducing the symptoms of diabetic gastroparesis in adult men.~   "
117790|NCT02025738|"~     Data on the perioperative management of patients cardiac implantable electronic devices~     (CIEDs) is limited and published guidelines rely mainly on the experience of the~     cardiologists and anesthesiologists who manage these patients. Depending on the device type~     and patient's dependency, these guidelines recommend the intraoperative magnet use,~     reprogramming of devices or no action. Magnet placement on a CIED (very simple and applicable~     method) has become the standard approach in many centers, while CIED reprograming by trained~     personnel is required in most centers. Therefore, our objective is to compare in a~     prospective randomized clinical trial the safety of intraoperative magnet use vs. CIEDS~     reprogramming vs. no intervention (in the appropriate subjects)~   "
117791|NCT02025725|"~     The purpose of this study is provide confirmation of the safety and efficacy of~     Metoclopramide Nasal Spray compared to placebo in reducing the symptoms of diabetic~     gastroparesis in adult women.~   "
117792|NCT02025712|"~     The purpose of this study is to determine whether exemestane plus everolimus are effective in~     the treatment of patients who have achieved disease stabilization after induction~     chemotherapy for hormone-receptor positive metastatic breast cancer.~   "
117793|NCT02025699|"~     The TAILORED-Treatment consortium was established to develop new tools aimed to increase the~     effectiveness of antibiotic and antifungal therapy, reduce adverse events, and help limit the~     emergence of antimicrobial resistance in children and adults.~   "
117794|NCT02025686|"~     The hypothesis of this investigation is to observe if HBO have an anti-inflammatory effect in~     humans induced by tonic heat stimulation. It has been shown in animal studies with rats that~     HBO could reduce the paw edema induced by carrageenan as an inflammatory agent. The authors~     are not aware of similar studies in human subjects investigating this effect of HBO. Aim: To~     investigate the anti-inflammatory effect of HBO by reducing the hyperalgesia induced by heat~     stimulation in healthy subjects and promote future research and understanding of the~     anti-inflammatory processes in humans. The primary endpoint is a reduced area of secondary~     hyperalgesia after HBO.~   "
117795|NCT02025673|"~     Betatrophin is a newly identified hormone that promotes pancreatic beta cell proliferation,~     improves glucose tolerance and regulates lipids metabolism. A recent study showed that~     circulating concentrations of betatrophin doubled in type 1 diabetes. The objective of this~     study is to investigate the association of serum betatrophin levels with the progression of~     diabetic retinopathy in patients with type 2 diabetes and the level of betatrophin in~     gestational diabetes patients and pregnant women.~   "
118726|NCT02013531|"~     The purpose of this study is to investigate the efficacy and safety of flexibly dosed~     adjunctive brexpiprazole treatment in subjects with major depressive disorder and anxiety~     symptoms, who are experiencing an inadequate selective serotonin reuptake inhibitor~     (SSRI)/serotonin norepinephrine reuptake inhibitor (SNRI) response.~   "
117798|NCT02025634|"~     The purpose of this randomized, placebo controlled, single blind study is to determine if~     postoperative pain levels, as measured by a verbal numeric pain rating scale (VNRS), are~     reduced with the administration of IV acetaminophen when compared to a control group.~     Particular focus will be on the postoperative opioid consumption. In addition, we will~     ascertain if the total time the participant is in the PACU differs in those who receive the~     IV acetaminophen versus those who do not.~   "
117799|NCT02025621|"~     A study to evaluate levosimendan compared with placebo in reducing the composite event rate~     of all-cause death, perioperative MI, need for new dialysis, or use of mechanical assist~     (IABP, LVAD or ECMO) in subjects with reduced ejection fraction undergoing cardiac surgery on~     cardiopulmonary bypass (CPB).~   "
117800|NCT02025608|"~     The purpose of this study is to explore whether patients with restless legs syndrome (RLS)~     differ from healthy subjects in daytime and night time autonomic function and cardiovascular~     risk markers and whether 4 week treatment with pramipexole affects autonomic function and~     cardiovascular risk markers in patients with RLS.~   "
117801|NCT02025595|"~     The aim of this study is to investigate the effects of genetic and environmental risk factors~     on central nervous system (CNS) reward and satiety circuits in the etiology of obesity. The~     investigators will also investigate to what extent the alterations in CNS reward and satiety~     circuits are a cause or a consequence of the development of obesity.~   "
117802|NCT02025582|"~     Idiopathic Toe Walking (ITW) is a diagnosis normally of exclusion and likely, consequently,~     is approached in vastly varying ways of intervention, including serial casting, Botox~     injections and physical therapy. There is some evidence in the literature that children with~     ITW can somewhat correct their lack of heel-strike gait pattern at least temporarily. Kinesio~     Taping (KT) method is an intervention that is used in the outpatient physical therapy setting~     for various conditions such as post-operative edema, muscle facilitation of weakened rotator~     cuff muscles, and functional corrections in children with torticollis. This pilot study will~     strive to determine if KT may be effective by providing proprioceptive and neuromuscular~     re-education through thermal and mechanical fascial impositions, thereby improving passive~     joint range of motion (ROM) through reduction of passive muscle stiffness and improving~     ambulation through neuromuscular re-education in children with idiopathic toe walking. We~     will quantify passive muscle stiffness of the gastrocnemius and opposing anterior tibialis~     using non-invasive Shear Wave Elastography (SWE). Further we look at the kinematics and~     kinetics of the child's ankle during the gait cycle to further determine any effect(s) of KT~     on functional walking outcome measures. The intent is that the results from this study will~     serve as a platform from which to expound look at the long-term, if any, effects of KT on the~     muscle property and gait cycle pattern in children with ITW.~   "
117803|NCT02025569|"~     This study seeks to determine the effectiveness of Strain Counterstrain in the treatment of~     chronic ankle instability.~   "
117804|NCT02025556|"~     The purpose of this study is to determine whether monthly subcutaneous administration of~     LBR-101 is safe and provides migraine prevention in subjects with high frequency episodic~     migraine.~   "
117805|NCT02025543|"~     The purpose of this multi-site research is to validate a rapid magnetic resonance based~     confounder-corrected R-2 mapping method as a quantitative imaging biomarker of liver iron~     concentrations.~   "
117806|NCT02025530|"~     The United Kingdom has one of the highest rates of stillbirth in Europe, with more than 4,000~     stillbirths every year; which equates to more than 11 deaths every day. Furthermore, this~     rate has changed very little over the last 20 years. This loss of life and the adverse~     psychological consequences urgently needs addressing.~      A recent New Zealand study investigating modifiable factors associated with stillbirth (the~     Auckland Stillbirth Study) found that mothers who did not go to sleep on their left side had~     a twofold risk of late stillbirth (≥28 weeks gestation) compared to mothers who did go to~     sleep on their left side. These novel findings need urgent confirmation.~      This proposed study aims to confirm or refute these findings and to ascertain whether a~     preventative programme should be introduced. This proposed study aims to confirm or refute~     the findings of the Auckland Stillbirth Study.~      Participants will be recruited from maternity units in the Midlands and North of England (led~     by centres in Liverpool, Manchester, West Yorkshire and Birmingham). 291 women with a~     singleton late stillbirth without congenital abnormality will be interviewed by research~     midwives shortly after the birth. A control group of 580 women with ongoing pregnancies will~     be interviewed at a gestation group matched to that at which stillbirths occurred. These data~     will determine whether an intervention study should be considered. If there is a causal~     relationship between maternal sleep position and late stillbirth we estimate that upto 37% of~     late stillbirths might be prevented.~   "
117807|NCT02025517|"~     Treadmill gait training combined with cognitive tasks in Parkinson's disease.~   "
117808|NCT02025504|"~     Colonoscopy is the gold-standard for colorectal cancer screening in the US. However, complete~     colonoscopy can be a challenging technical procedure, even for expert gastroenterologists due~     to variations in patient anatomy, tortuous colons, and looping of the endoscope. Such~     obstacles can prolong colonoscopy, lead to complications, decrease polyp detection, and~     impact patient experience and tolerance. The investigators propose to evaluate the efficacy~     of a new non-invasive abdominal binder (ColoWrap®) in improving the performance and tolerance~     of colonoscopy by way of a randomized, blinded clinical trial. Eligible participants~     undergoing colonoscopy at University of North Carolina Hospitals (UNCH) will be recruited for~     the study and randomized to either the ColoWrap intervention or sham arm. Colonoscopy will be~     performed per usual operating procedures. The primary outcome will be time to distal extent~     (cecal intubation time). Secondary outcomes include colonoscopy completion rate, use of~     ancillary maneuvers, medication usage, procedural difficulty, patient comfort, and operator~     and assistant fatigue and pain. Efficacy will be assessed on the basis of pairwise~     comparisons between groups with respect to primary and secondary outcomes.~   "
117835|NCT02025153|"~     To determine whether central sensitization is a mechanism of CPSP (chronic postsurgical pain)~     in women who will develop CPSP compared to women with no CPSP after hysterectomy. This~     mechanism is illustrated by a higher pain score in experimental pain models such as tonic~     heat stimulation, increased evoked mechanical temporal summation and increased wound~     hyperalgesia.~   "
117809|NCT02025491|"~     Disseminated leishmaniasis (DL) is an emerging and severe form of leishmaniasis, with~     increasing prevalence in Bahia, Brasil. It is characterized by multiple acneiform, papular~     and ulcerated lesions localized on the face, chest, abdomen and extremities. The number of~     lesions ranges from 10 to hundreds, and mucosal disease has been documented in more than 40%~     of the cases.~      DL is a hard to cure disease and therapeutic failure with pentavalent antimony has been~     documented in up to 70% of the cases caused by L. braziliensis in the endemic area of Corte~     de Pedra, Bahia. The majority of DL patients need several courses of antimony or the use of~     high dose of Amphotericin B desoxicolate to cure. Therefore DL patients are exposed to~     relevant drug toxicity, high morbidity due to a long lasting disease, with an important~     socio-economic impact. Our hypothesis is that liposomal Amphotericin B has a higher cure rate~     than historic cure rates of pentavalent antimony in the treatment of disseminated~     leishmaniasis.~   "
117810|NCT02025478|"~     The investigators hypothesize that children receiving human milk will maintain a greater~     diversity of helpful bacteria in their gut and have lower levels of inflammatory proteins in~     the blood compared with children not receiving human milk.~   "
117811|NCT02025465|"~     Atrial Fibrillation and atrial flutter (AF/FL) is the usually irregular beating of the heart~     and is a rapidly growing cause of hospitalization. Between 1993 to 2007 AF/FL~     hospitalizations have increased 203% compared to a 71% increase for all hospitalizations.~     Changing procedure management such as ablation, transesophageal have had a minimal impact on~     the trends and there is a need to evaluate Emergency Department (ED) management options of~     AF/FL that may decrease hospitalizations.~      The most commonly used medications to control heart rate are metoprolol (MET), a beta~     blocker, or diltiazem (DT), a calcium channel blocker. Beta blockers are medications that~     cause the heart to beat more slowly and with less force. DT also helps blood vessels open up~     to improve blood flow. Both DT and MET are used alone or together with other medicines to~     treat severe chest pain (angina), high blood pressure (hypertension) or rapid heartbeat. Both~     are equally acceptable according to recent guidelines for AF/FL. There are limited studies~     comparing MET to DT for rate control for AF/FL.~      The initial goal for AF/FL management in the Emergency Department is usually rate control.~      The most commonly used rate control medications are metoprolol (MET), a beta blocker, or~     diltiazem (DT) a calcium blocker. Three major guidelines, including the American College of~     Cardiology (ACC) and the American Heart Association (AHA) indicate beta blockers and DT are~     equally acceptable medications for rate control in AF (3,4,5) assuming no contraindications.~      There are limited studies comparing beta blockers (BB) to DT for rate control for AF:~        1. Demircan, et. al., compared bolus intravenous BB and DT in 40 patients over a 20 minute~          period. No follow-up information after 20 minutes was reported. No attempt was made to~          look at intermediate or long term results. No patients converted to normal sinus rhythm~          over this short treatment period and there was slightly more rate decrease at 20~          minutes, with DT versus BB (6).~        2. Time from medication administration to heart rate and rhythm control. Additionally,~          currently guidelines consider BB or DT medications to slow AF/FL; however, there are~          some suggestions that BB may not only slow heart rate in AF/FL (as does DT) but also~          increase all AF/FL conversion from AF/FL to normal sinus rhythm(2), and aid in~          maintaining normal sinus rhythm (NSR) after cardioversion (10). With recent onset AF/FL~          occurring within 48 hours prior to the arrival to the ED, approximately 50% of AF/FL~          patients convert to normal rhythm spontaneously within 24 hours after arrival to the ED~          (6), making evaluation of current limited studies difficult. Thus, the investigators~          wish to examine the effect of initial medication strategy on time to NSR in a larger~          sample than has been previously performed.~        3. A randomized study of 48 patients in China reported significantly slower heart rate up~          to 20 minutes with DT 10mg IV versus metoprolol 5mg IV but not after 30 minutes (7).~        4. A retrospective study of post-operative coronary bypass patients showed the intravenous~          administration of the BB, esmolol, to be more effective than DT for rate control and~          conversion of AF/FL (8).~        5. Hassan et al reported no difference in conversion to regular rhythm with esmolol verses~          DT in a small, under powered, randomized study of fifty ED patients (9). Conversion to~          sinus rhythm occurred in 10 patients (42%) in the DT group compared with 10 patients~          (39%) in the esmolol group (P = 1.0). There were no statistically significant~          differences in heart rate between the two medications at 1, 6, 12, and 24 hours after~          initiation of esmolol or DT infusion.~      Examples of such well quoted strategy trials are the COURAGE trial published in the New~     England Journal of Medicine and the PROMISE Trial, a worldwide multi-centered study that is~     nearing completion goal of 10,000 patients of which, Charleston Area Medical Center (CAMC)~     has enrolled approximately 100 patients. In this trial, patients being evaluated for chest~     pain will be randomized to two treatment strategies and subsequent outcomes will be recorded.~      Strategy trials do not attempt to manage treatment after an initial management strategy has~     been determined by randomization, but, whether the initial treatment affects long-term~     outcomes.~      This will be a prospective, randomized study comparing the outcomes of a strategy using~     either MET or DT in patients with AF presenting to the Charleston Area Medical Center (CAMC)~     ED. After presentation and receiving consent, the patient will be randomized to receive~     either MET or DT.~   "
117812|NCT02025452|"~     Many children admitted to hospital in Botswana without bloody diarrhoea are presumed to have~     viral gastroenteritis and so not treated with antibiotics - but they may indeed have a~     treatable cause for their illness. We will conduct a randomized trial to see if rapid testing~     using novel methods to identify potentially treatable causes of diarrhoea leads to improved~     outcomes. We will also be randomizing children to probiotic therapy versus placebo (the~     standard of care) to see if this treatment decreases the duration of diarrhoea. The proposed~     study is a pilot trial, necessary before embarking on a large multi-centre trial.~   "
117813|NCT02025439|"~     The purpose of this study is to examine the safety and efficacy of repetitive transcranial~     magnetic stimulation (rTMS) combined with Amantadine relative to rTMS Alone and Amantadine~     Alone for persons in chronic states of seriously impaired consciousness. The hypothesis is~     that provision of rTMS+Amantadine will provide a safe yet synergistic effect that induces or~     accelerates functional recovery.~   "
117814|NCT02025426|"~     Phenylephrine administration is associated with reductions in CO and SctO2 compared with~     ephedrine when used for blood pressure management in women with pre-eclampsia undergoing~     cesarean delivery under spinal anesthesia.~   "
117815|NCT02025413|"~     The primary objective of the preliminary lead-in study is to determine whether circulating~     tumor cells in patients with metastatic progressive castration-resistant prostate cancer or~     metastatic progressive breast cancer can be captured using a novel mesenchymal-marker based~     ferrofluid (N-cadherin or O-cadherin based).~      The primary objective of each comparative cohort (second stage, prostate cancer) is to~     compare the non-detection rate of circulating tumor cells between the standard and novel~     methods.~   "
117816|NCT02025400|"~     The investigators have previously reported on patient utilization of an eRehab patient~     education web portal that utilizes streaming, clinician prescribed video instruction to~     motivate and inform patients in self-care of their orthopedic condition, focusing on the~     importance of a home exercise program. The greatest barrier to patient use of this web-based~     home exercise treatment plan was the initial access to the program. The purpose of this study~     is to compare an Internet-based patient education rehab portal (eRehab) to formal physical~     therapy (PT) in terms of patient costs and outcomes.~   "
117817|NCT02025387|"~     Examine whether the measurement and feedback of physical activity increase the physical~     activity in women who underwent midline incision, gynecological surgery~   "
117818|NCT02025374|"~     Aim of the Study To compare the effects of hyperbaric bupivacaine plus fentanyl with~     hyperbaric levobupivacaine plus fentanyl on spinal block quality, haemodynamics and need for~     analgesics in patients undergoing elective cesarean section. Our hypothesis is that~     hyperbaric levobupivacaine will provide equal block quality, but better haemodynamic~     conditions compared to hyperbaric bupivacaine.~   "
117819|NCT02025361|"~     Transrectal ultrasound guided prostate biopsy (TRUS-Bx) is the gold standard method for~     prostat cancer diagnosis. Cancer detection rate is an important issue in TRUS-Bx. Effective~     biopsy protocol is necessary to enhance cancer detection rate during the procedure. Patient~     tolerance may improve the protocol effectiveness and quality.~      Adequate patient tolerance with optimal local anesthesia may enhance cancer detection rate in~     TRUS-Bx.~   "
117820|NCT02025348|"~     This is an open-label, randomised, 4-way crossover study in twelve healthy male volunteers.~      The study will characterise the performance of IntelliCap® by evaluating the plasma~     concentration and pharmacokinetic profile of a probe drug (IMP; metoprolol) released from~     IntelliCap® with three different release profiles and the plasma concentration and~     pharmacokinetic profile of the same probe drug after a single dose of an oral solution.~   "
117821|NCT02025335|"~     CMV is one of the most important opportunistic infection in transplant recipients. In South~     Korea, more than 95% of adults reveal sero-positivity for CMV IgG. Until now, sero-positivity~     for CMV IgG before solid organ transplantation is a laboratory test of choice to stratify the~     risk of CMV reactivation after solid organ transplantation. Theoretically, CMV-specific~     cell-mediate immune response before solid organ transplantation will further categorize the~     patients into high or low risk of CMV development after solid organ transplantation. The~     investigators thus evaluate the usefulness of CMV-specific ELISPOT assay in kidney transplant~     candidates to predict the development of CMV infection after kidney transplantation.~   "
117822|NCT02025322|"~     This study aims to investigate the effectiveness of an in-person peer mentoring and health~     literacy intervention on improving medication adherence, HIV-1 viral load, CD4+ T lymphocyte~     counts, and HIV medical appointment attendance among newly-diagnosed and/or medication~     non-adherent HIV-positive individuals, compared to standard of care provider/staff-delivered~     education.~   "
117846|NCT02025010|"~     This study is comparing the safety and effectiveness of abiraterone acetate alone, followed~     by the addition of prednisone (when the participant's disease worsens or the physician feels~     it would lessen symptoms of toxicity) versus the current approved treatment regimen which~     involves the concomitant use of prednisone in conjunction with abiraterone acetate.~     Additionally, this study is also examining why participants stop responding to treatment with~     abiraterone acetate by evaluating blood and tissue.~   "
117823|NCT02025309|"~     Sugammadex, a modified γ-cyclodextrin is a selective relaxant-binding agent that reverses the~     effects of steroidal neuromuscular blocking agents, rocuronium and vecuronium. It shows its~     activity by encapsulating these. Likewise, some other steroid hormones and drugs like~     flucloxacillin, toremifene, fusidic acid can also be effected. Thus, assuming that~     methylprednisolone would also be encapsulated by sugammadex and decrease its efficiency, in~     this study we aimed to compare the recovery times from recuronium-induced muscle relaxation~     after reversal with sugammadex between patients who receive intraoperative methylprednisolone~     or not.~      After institutional review board (IRB) approval and informed consent, 100 patients will be~     enrolled in this prospective, single center, controlled study. Anaesthesia will be induced~     with propofol (3mg/kg) and rocuronium (0.6 mg/kg), followed by sevoflurane maintenance.~     Patients will be divided into two groups (Group M, n: 53 and group C, n: 47,~     methylprednisolone administered group and control group respectively) according to the~     requirement of methylprednisolone administration which is dictated by the type of the~     surgical procedure. Neuromuscular blockade will be monitored using calibrated train-of-four~     (TOF-Carescape B 650 NMT, GE, Connecticut, USA). Once rocuronium-induced neuromuscular~     blockade recovers spontaneously to TOF-count-two, all patients will receive 2.0 mg/kg of~     sugammadex. Neuromuscular monitoring will be continued until recovery of the TOF ratio to 0.9~     at the ulnar nerve. The time to recovery of TOF to 0.7 and 0.9 will be compared in both~     groups. The statistical analyses will be performed using Student T Test and Mann-Whitney U~     test.~   "
117824|NCT02025296|"~     Recently, we generated a new multidisciplinary ubiquitous healthcare system by upgrading our~     clinical decision supporting system (CDSS) rule engine, and integrating a physical~     activity-monitoring device and dietary feedback into a comprehensive package. We hypothesize~     that individualized multidisciplinary u-healthcare service combined with exercise monitoring~     and dietary feedback will result in better glucose control with less hypoglycemia in an~     elderly population.~   "
117825|NCT02025283|"~     The aim of this study is to compare early and long term efficacy of lumbar radiofrequency~     nucleoplasty and targeted disc decompression in patients with lumbar radiculopathy who failed~     previous conventional therapy. Medical records of 37 patients undergoing targeted disc~     decompression, 36 patients undergoing lumbar radiofrequency nucleoplasty were retrospectively~     examined.Visual Analogue Scale (VAS), Numerical Rating Scale (NRS), Functional Rating Index,~     Backache index, Oswestry Lumbar Back Pain Disability Index, Rolland-Morris Lumbar Back Pain~     Questionnaire scales were used before treatment and 1,6,12 months after the procedure. North~     American Spine Society Satisfaction Scale was used at 12th month after the procedure.~   "
117826|NCT02025270|"~     In this study, we performed autologous BMDMSC transplantation to the testis of Azoospermic~     patients in a trial to enhance and activate the spermatogonial stem cells of the testis and~     aiming to produce motile sperm.~   "
117827|NCT02025257|"~     The purpose of this study is to investigate the effects of exercise for patients with~     coronary artery disease (CAD) aged 80 years and older, with special reference to maximum~     aerobic capacity, muscle endurance, physical functioning, level of physical activity, health~     related quality of life, anxiety, depression and endothelial function, compared to a control~     group.~   "
117828|NCT02025244|"~     Upper Gastrointestinal Submucosal Tumors are tumors arising from subepithelial layers of~     esophageal, gastric or duodenal wall. They usually have an intact mucosa lining on the inner~     surface. The prognosis and treatment of these tumors depend on their correct diagnostics and~     mitotic activity in case of Gastrointestinal Stromal Tumors (GIST). A standard forceps biopsy~     of mucosa is usually not helpful. Therefore, biopsy techniques capable of reaching deeper~     layer of Upper GUT are needed. The investigators compare KHB and EUS-FNA in the diagnostics~     of Upper gastrointestinal Submucosal Tumors.~   "
117829|NCT02025231|"~     The purpose of the study is to evaluate the short- and long term toxicity of radiotherapy to~     patients with recurrent high-grade glioma who have previously received radiotherapy and to~     determine the best dose and treatment regimen. Positron emission tomography (PET) using an~     amino acid tracer, 18-fluoro-ethyltyrosine (18F-FET), is used for target delineation.The~     study examines, in four sequential treatment groups, the effect of dose, hypofractionation~     and treatment volume on toxicity. Upon completion of the phase I part, the study progresses~     to phase II where the best dose- and treatment regimen will be chosen for treatment.~   "
117830|NCT02025218|"~     To evaluate the effect of re-administration of gefitinib to EGFR-mutated NSCLC patients who~     had been treated with at least one line of TKIs followed by another line of treatment~     (non-TKI)~   "
117831|NCT02025205|"~     The aim of this prospective, randomized, controlled, one-way crossover study is to assess and~     compare the efficacy of the Zephyr endobronchial valves vs. Standard of Care (SoC) in~     patients suffering from COPD with Homogeneous Emphysema. Patients will be followed up for 12~     months after randomization. Patients in the SoC arm will crossover to the EBV treatment arm~     after the 6-month visit and will be followed up for 6 additional months.The primary objective~     is the variation of FEV1 between baseline and 3-month follow-up visit. The secondary~     objectives will evaluate quality of life, exercise capacity, dyspnea (including BODE index)~     changes, target lobe volume reduction, as well as safety outcomes.~   "
117832|NCT02025192|"~     The purpose of this study is to determine the maximal tolerated dose (MTD) or recommended~     phase 2 dose (RP2D) of tucatinib (ONT-380) and to assess the safety and tolerability of~     tucatinib (ONT-380) combined with capecitabine alone, trastuzumab alone and with both~     capecitabine and trastuzumab in patients with HER2+ metastatic breast cancer.~   "
117833|NCT02025179|"~     This extension study will only enroll individuals who have completed one year of treatment in~     the parent protocol Effect of Teriparatide, Vibration and the Combination on Bone Mass and~     Bone Architecture in Chronic Spinal Cord Injury (NCT01225055). This study will allow those~     individuals who received Teriparatide (20ug/day) and vibration (10 min/day) during the parent~     study to be treated for a second year and will allow those individuals who received~     teriparatide-placebo to have the opportunity to have a full year of teriparatide therapy.~     This study will determine if two years of exposure to teriparatide will result in a greater~     increase in Bone Mass Density (BMD) than that seen after a single year's treatment. Subjects~     will be evaluated at 6 and 12 months after initiating treatment with measurement of bone~     density as well as bone markers of formation and resorption.~   "
117836|NCT02025140|"~     • Introduction: Effective pain control is critical in pediatric dentistry. The effectiveness~     of pain control in children can be influenced by child characteristics .~      Objectives: The Purpose of the study is to compare the pain perception and the effectiveness~     of anesthesia between the computer-controlled local anesthetic delivery system (CCLAD) and~     the traditional inferior alveolar nerve block (IANB) in pulptomies of the mandibular second~     primary molars.~      Materials and Methodology: The study sample includes 90 healthy children who are selected~     randomly from the R4 electronic filing system in King Abdulaziz University Hospital (KAUH)~     with age range from 5-9 years. The child is required local anesthesia for pulpotomies in the~     mandibular second molars. The sample will be divided randomly to one of these 3 groups: group~     A is composed of 30 patients who will be anesthetized by the traditional IANB. Group B~     includes 30 patients will be anesthetized by the IANB using CCLAD. While, the remaining 30~     patients will be assigned in group C and will be anesthetized by periodontal ligament~     injection anesthesia using the CCLAD. The pain perception levels after the injection is~     assessed by a Wing-Baker faces pain scale. Effectiveness of the anesthesia during each step~     in pulpotomy is measured using Sounds, eyes and motor (SEM) scale. After the treatment by 24~     hours parents will be contacted by the telephone to ask about the presence of postoperative~     pain or lip biting. Statistical analysis is carried out using SPSS version 16.00.~   "
117837|NCT02025127|"~     Septic shock represents the body's dysregulated response to an infection, manifesting as~     persistent hypotension (mean arterial pressure < 70 mmHg) despite intravenous (IV) fluid~     resuscitation. Severe sepsis and septic shock are major healthcare problems, affecting~     millions of people around the world each year In critically ill patients without shock,~     provision of enteral nutrition within 24-48 hours has shown to preserve intestinal~     epithelium, maintain brush border enzyme activity, maintenance of barrier function to enhance~     immune function, and preservation of tight cell junctions to reduce permeability. These~     benefits of enteral nutrition are postulated to prevent downstream complications of~     nosocomial infections and the multiple organ dysfunction syndrome (MODS), though direct data~     addressing this question are lacking.~      There is a paucity of data on the timing and role of enteral nutrition in septic shock.~      Specific aim 1: To examine the effect of enteral nutrition of >50 kcal/day but <600 kcal/day~     compared to no enteral nutrition initiated with 24 hours of admission on the number of~     intensive care unit free days' in patients with septic shock.~      Hypothesis 1: The investigators hypothesize that amongst mechanically ventilated patients~     with a diagnosis of septic shock, the initiation of early enteral nutrition of >50 kcal/day~     but <600 kcal/day, as compared to no enteral nutrition, improves the primary outcome of~     number of intensive care unit free days'.~      Specific aim 2: To examine the effect of enteral nutrition of >50 kcal/day but< 600 kcal/day~     initiated with 24 hours of admission on in-hospital mortality, mechanical ventilator free~     days, time to 50% reduction in vasopressor dose, and time to initiation of physical therapy~     in patients with septic shock.~      Hypothesis 2: The investigators hypothesize that amongst mechanically ventilated patients~     with a diagnosis of septic shock, the initiation of early enteral nutrition of >50 kcal/day~     but <600 kcal/day, as compared to no enteral nutrition, decreases mortality, duration of~     mechanical ventilation, time to 50% reduction in vasopressor dose, and time to initiation of~     physical therapy.~   "
117838|NCT02025114|"~     This is an open-label, non-randomized, multicenter phase Ib/II study, which is composed of a~     phase Ib dose escalation part and a phase II dose expansion part. Patients will receive~     selumetinib in combination with gefitinib 250mg daily. This study will enroll EGFR-mutated~     NSCLC patients who have developed acquired resistance to EGFR TKI treatment.~   "
117839|NCT02025101|"~     Description of the phenomena Slow Coronary Flow (SCF), according to the data that has been~     collected from patients hospitalized with specific criteria. Clinical follow-up of these~     patients to determine whether they suffered from any cardial or psychological disorders that~     might be a result of SCF.~   "
117840|NCT02025088|"~     Acne scars have high prevalence, significant impact on quality of life and are a therapeutic~     challenge for dermatologists. Previous studies have shown promising results for the treatment~     of acne scars with non-ablative fractional laser and microneedling, however there are no~     studies comparing the these techniques. Therefore, the objective of this study is to compare~     the effectiveness of treatment of atrophic acne scars on the face with non-ablative~     fractional erbium laser and microneedling.~   "
117841|NCT02025075|"~     The goal of this study is to investigate the effect of depth of neuromuscular block (NMB) on~     global and regional (dependent versus nondependent) respiratory mechanics during laparoscopic~     surgery. Furthermore, we will investigate if the level of NMB influences intraoperative~     hemodynamic and cerebral oxygenation.~   "
117842|NCT02025062|"~     The intervention tested in this research project aims to reduce this inequality by improving~     the management of elderly head and neck cancer patients with a specific management. Indeed,~     the treatment of elderly head and neck cancer patients has specificities concerning treatment~     options, their tolerance, psychological management, nutritional and functional status, and~     support needed at home. To assess the overall needs of the elderly patients, an assessment~     known as comprehensive geriatric assessment (CGA) can be performed by a geriatrician with~     extensive testing and questionnaires. This assessment is long and requires an experienced~     geriatrician. It leads to the development of an individualized treatment plan (physiotherapy,~     psychological follow-up, support at home, nutritional management ...) and follow-up to adapt~     the necessary cares for the duration of the cancer treatment. The CGA utility has been~     studied in elderly patients with nonmalignant diseases. Studies have shown that CGA allowed~     improving survival and maintaining the elderly at home.~   "
117843|NCT02025049|"~     Inflammation of the pancreas often leads to severe damage not only to the pancreas but also~     to other organs in the abdomen as well as to complications in organs further away like the~     lung and the kidney. This trial will examine if DP-b99, given to patients with non-severe~     inflammation of the pancreas, can mitigate the development of processes that can lead to~     serious complications of this disease.~   "
117844|NCT02025036|"~     A three-arm Phase III trial was started in Oct. 2014. Definitive chemoradiotherapy with~     cisplatin plus 5-fluorouracil is the standard in Western countries in esophagus cancer. But~     in China because of its toxic reaction, most of patients stop the halfway. Because low~     toxicity, the chemotherapy regimen of capecitabine with or without oxaliplatin are widely~     used in clinical.~      The purpose of this study is to confirm the difference of Capecitabine plus with or without~     oxaliplatin over cisplatin plus 5-fluorouracil with definitive chemoradiotherapy for~     esophagus squamous cell carcinoma. A total of 630 patients will be accrued from China within~     2 years. The primary endpoint is overall survival and the secondary endpoints include~     progression-free survival, response rate, pathologic complete response rate and adverse~     events.~   "
117845|NCT02025023|"~     Local injection of 5-fluorouracil into a chalazion (stye) is as effective as local injection~     of triamcinolone (steroid) and incision and curettage for treatment of chalazia.~   "
117910|NCT02024178|"~     This pilot clinical trial studies ultrasound imaging in finding prostate cancer in patients~     undergoing surgery. Diagnostic procedures, such as ultrasound imaging, may help find and~     diagnose prostate cancer. This study will serve as an analysis of the Histo-Scanning~     technology for the purpose of determining its ability to identify sites of prostate cancer at~     the time of prostate ultrasound.~   "
117847|NCT02024997|"~     The overall aim of this study is to investigate a novel dual instance planning method to~     make use of the respiratory motion to improve pancreatic radiation therapy (RT) treatment~     planning.~      Specific Aim 1: Acquire patient abdominal MRI and CT at both deep inspiration (INSP) and~     expiration (EXP) positions and characterize the changes in geometric relationships between~     the INSP and EXP instances for tumor and normal tissues including stomach, duodenum and~     bowel. We hypothesize that INSP and EXP MRI and CT characterization will allow identification~     of patients who may benefit from the dual instance planning method.~      Specific Aim 2: Develop, investigate and evaluate plans based on free breathing, single~     instance breath hold, and the novel dual instance anatomical information. We hypothesize that~     use of the dual instance method will lead to improved plans, demonstrated by the ability to~     increase dose to the target, while maintaining the clinically-accepted normal tissue dose~     constraints.~   "
117848|NCT02024984|"~     INTRODUCTION Polycystic ovary syndrome (PCOS) is one of the most common female endocrine~     disorders (Fauser et al., 2011). It is a complex, heterogeneous disorder of uncertain~     aetiology, but there is strong evidence that it can, to a large degree, be classified as a~     genetic disease (Fauser et al., 2011). Genetic and environmental contributors to hormonal~     disturbances combine with other factors, including obesity (Diamanti-Kandarakis et al.,~     2006). Ovarian dysfunction and hypothalamic pituitary abnormalities contribute to the~     etiology of PCOS (Doi et al., 2005).~      It produces symptoms in approximately 5% to 10% of women of reproductive age (12-45 years~     old). It is thought to be one of the leading causes of female subfertility (Goldenberg and~     Glueck, 2008).~      Its prevalence has increased with the use of different diagnostic criteria and has recently~     been shown to be 18% (17.8 ± 2.8%) in the first community-based prevalence study based on~     current Rotterdam diagnostic criteria (March et al., 2010).~      AIM OF THE WORK The study will compare the luteal phase (early) administration of clomiphene~     citrate to the conventional (late) administration of the same drug in the follicular phase as~     regards ovarian response in PCOS.~      Research Question What is the difference between administration of clomiphene citrate in the~     luteal phase and the follicular phase for ovulation induction in women with PCOS? Research~     Hypothesis Luteal phase administration of clomiphene citrate protocol gives better results~     than conventional administration of clomiphene citrate in the follicular phase as regards~     ovarian response in PCOS.~   "
117849|NCT02024971|"~     The purpose of this study is to investigate the safety and efficacy of long-term use of~     pioglitazone/metformin hydrochloride combination tablets in the routine clinical setting in~     patients with type 2 diabetes mellitus for whom therapy with pioglitazone hydrochloride~     combined with metformin hydrochloride is considered suitable.~   "
117850|NCT02024958|"~     Energy expenditure (EE) in critically ill patients is highly variable depending on the~     initial severity of the disease and treatments. Clinicians need to measure EE by indirect~     calorimetry (IC) to optimize nutritional support. IC devices available on the market have~     insufficient accuracy for clinical and research use. A new IC is being developed to meet~     these needs.~      Objectives: Validation of a reliable and easy-to-use IC device.~      Primary objective:~      • Accuracy of EE measurements (kcal/d measured over 30 min) of the new and the reference IC~     devices in intubated ICU patients on mechanical ventilation~      Secondary objectives:~        -  Accuracy of EE measurements in ICU patients of spontaneous breathing~        -  Accuracy of EE measurement during ~30 min. vs. the sum of 6 periods of 60 min/12 hrs~        -  Accuracy of EE measurements in ICU patients on non-invasive mechanical ventilation~      Design: Prospective, controlled, observational multicenter study.~      Subjects: 182 ICU patients.~   "
117851|NCT02024945|"~     The purposes of this study were to assess Quality of Life (QoL) and urination urge,~     incontinence, and micturition frequency including nocturia after 4 and 12 weeks treatment~     with propiverine.~   "
117852|NCT02024932|"~     The purpose of this study was to determine if BVS857 is safe, tolerable and increases thigh~     muscle thickness in patients with spinal bulbar and muscular atrophy (SBMA).~   "
117853|NCT02024919|"~     Coronary artery ectasia (CAE) has been defined as localized or diffuse dilatation of~     epicardial coronary arteries more than 1.5 fold of adjacent normal segments. Isolated CAE~     constitutes minor portion of the total CAE cases, with an incidence of 0.1% to 0.79% in which~     coronary artery stenosis or severe valvular heart diseases are not present. CAE represents~     not only an anatomical variant but also a clinical constellation of coronary artery disease~     (CAD) like association with myocardial ischemia and acute coronary syndromes. Patients with~     CAE without significant coronary narrowing may still present with angina pectoris, positive~     stress tests, or acute coronary syndromes. Impaired epicardial and microvascular perfusion~     were demonstrated in ectatic coronary arteries.~      Myocardial blush grading (MBG) technique has been utilized in various conditions such as~     acute myocardial infarction, coronary artery ectasia, syndrome X and idiopathic dilated~     cardiomyopathy to evaluate myocardial perfusion.~      There is still no consensus for management of CAE. Previously improvement of coronary flow~     has been demonstrated by mibefradil in patients with slow coronary flow. A new trial is~     needed to explore the effect of calcium channel blockers (CCB) in isolated CAE. Diltiazem~     improves myocardial perfusion by blocking calcium channels in coronary arteries. This agent~     has been widely used in coronary catheter labs to prevent and treat no-reflow.~      The current study with prospective design was therefore set up to assess whether epicardial~     flow and tissue level perfusion would be improved by diltiazem in myocardial regions~     subtended by the ectatic coronary arteries among patients with isolated CAE.~   "
117854|NCT02024906|"~     The purpose of this study is to help the researchers understand if using a soy supplement~     impacts cardiovascular disease risk factors in patients with subclinical hypothyroidism.~   "
117855|NCT02024893|"~     -  Shoulder pain and dysfunction are common problems in overhead sports, due to extreme~          ranges of motion and repetitive loading. Predisposing factors include inadequate range~          of motion (ROM), such as a reduction in total ROM or a shift of balance between internal~          and external rotation. Such a shift may be the result of soft tissue adaptations to the~          activity demands, or reflect a structural outcome of Humeral retroversion. A shift in~          the range of motion may be detrimental to the rotator muscle function, which may create~          another risk factor for shoulder injury.~        -  The purpose of this study is to document shoulder range of motion, humeral retroversion,~          rotator muscle strength and fatigue in several groups of overhead athletes undergoing a~          routine pre season screening once a year, and investigate the interaction between those~          factors in the different groups.~   "
117856|NCT02024880|"~     In-vitro fertilization (IVF) treatment involves development of multiple follicles following~     ovarian stimulation, oocyte retrieval and embryo transfer (ET). ET is the final and most~     crucial step of IVF treatment.~      The ET catheter has to pass through the endocervical canal to go into the uterine cavity~     through the internal os. The endocervical canal may be filled up with mucus or blood. Embryos~     trapped in the mucus or blood after the passage of the endocervical canal may not be able to~     implant into the endometrium. Guardia™ Pro Protective ET catheter is designed to allow the~     safe passage of embryos through cervical mucus and blood as its outer sheath protects the~     embryo through entry and then opens in petals to further advance the inner catheter and~     gently place the embryo.~      The hypothesis of this study is that the pregnancy rate is significantly higher after ET~     using protective ET catheters.~   "
117857|NCT02024867|"~     The objective of this study is to determine if there is a difference in treatment failures~     and recurrent skin infections when patients are given 3 or 10 days of antibiotics for~     uncomplicated skin abscesses after they have been surgically drained.~   "
117858|NCT02024854|"~     The aim of the study is to investigate physiological response, social/emotional response and~     general movements in preterm infants when they are given skin-to-skin contact with the mother~     (intervention) or standard care (incubator) right after delivery. Preterm infants will be~     randomized to either intervention or standard care group. Data on body temperature, blood~     glucose, hart rate, respiration rate and oxygen saturation will be obtained. In addition the~     infant will be video-recorded during the first 24 hours and at three months of age for~     analysis of the general movements.~   "
117859|NCT02024841|"~     Phase I study on the maximum tolerated dose (MTD) and the recommended dose (RD) of~     intraperitoneal docetaxel combined with intravenous cisplatin and oral TS-ONE in gastric~     cancer patients with peritoneal carcinomatosis~   "
117860|NCT02024828|"~     The purpose of this study was to test the effect of four randomly assigned approaches to oral~     feeding transition on feeding outcomes in preterm infants.~   "
117861|NCT02024815|"~     Radiotherapy is required to overcome pain and to evoke recalcification in multiple myeloma~     (MM) patients. Approximately 70% of all MM patients receive one or more radiotherapies in the~     course of their illness. The relief of pain is obtained in 75 - 100%. Recalcification is~     achieved in 40 - 50% of the irradiated bone destructions.There were a lot of randomized~     trials showed the same effect of single (SF) and multiple fractions (MF) in pain relief and~     recalcification for patients with painful bone metastases from solid tumors. The role of~     different palliative radiotherapeutic regimens for MM is not well established due to lack of~     clinical trials. Our prospective study analyzed the effect of two different radiotherapeutic~     regimens in the treatment of MM on pain relief, analgesics consumption and recalcification.~   "
117862|NCT02024802|"~     There has been a significant increase in the number of prescriptions being filled for Custom~     Compounded Pain Creams. This study serves to evaluate the patient perception and satisfaction~     with this type of pain therapy allowing us to identify any statistically relevant~     relationships that may exist between this type of therapy and patient pain perception. A~     secondary goal would be to identify any significantly relevant relationships that may exist~     between this change in pain perception (if any) and the patients overall sense of well-being.~     The investigators' null hypothesis is that greater that 85% of people will see an significant~     decrease in perceived pain levels and greater than 85% increase in patient overall sense of~     well being.~   "
117863|NCT02024789|"~     This multi-center, randomized, double-blind, 3-arm, parallel-group, placebo-controlled study~     will evaluate the efficacy and safety of RG1662 in adults and adolescents with Down syndrome.~     Subjects will be randomized to receive RG1662 either at low or high dose or placebo orally~     twice daily for 26 weeks.~   "
117864|NCT02024776|"~     Despite recent advances, morbidity and mortality associated to major abdominal surgery is~     significant. A poor physical condition and functional status reduces the ability of a person~     to cope, mentally and physically, with hospitalization and surgery and may compromise~     functional recovery, potentially leading to postoperative complications and death.~     Prehabilitation aims to enhance functional capacity preoperatively for better toleration of~     surgery and to facilitate recovery and eventually the prognosis of the surgical patient.~     Whereas the benefits of cardiopulmonary fitness programs are well established, the~     accessibility, sustainability of effects, and impact on the surgical outcome of these~     programs are unsolved issues. Wellness programs based on integrated care services supported~     by Information and Communication Technology (ICT) can overcome such limitations. The~     investigators hypothesized that a prehabilitation program, inducing beneficial effects on~     exercise capacity, may improve the surgical outcome in high-risk patients. Moreover, ICT~     support may contribute to increase the adherence and sustainability of this intervention.~   "
117865|NCT02024763|"~     The aim of this study was to evaluate the impact of a classroom teachers' educational~     intervention on 1st and 2nd grades children's physical activity level and energy expenditure~     during physical education classes in elementary public schools, in São Paulo, Brazil.~   "
117880|NCT02024568|"~     Paclitaxel is chemotherapeutic agent used in many of the most common anti-cancer regimens.~     Its use is frequently associated with moderate to severe muscle and joint pain that may~     persist for several days after the treatment. This side effect, known as Arthralgia-Myalgia~     Syndrome, has a significant impact on the quality of life and functional abilities of those~     receiving the treatment, and is not alleviated by many of the interventions attempted for~     that purpose.~      Sporadic reports suggest that a drug called gabapentin may be effective in the management of~     this adverse effect. Observations from our practice indicate that pregabalin, which possesses~     similar biological activity to that of gabapentin, may also be useful in preventing and~     treating paclitaxel associated myalgia - arthralgia.~      The current study represents an initial evaluation of the hypothesis that pregabalin may be~     beneficial in the management of the symptoms due to the Arthralgia-Myalgia Syndrome. The~     investigation will be carried out in the format of a small scale, randomized, placebo~     controlled trial with patients receiving paclitaxel in the course of standard treatment for~     breast cancer.~   "
117881|NCT02024555|"~     The primary purpose of this study is to investigate the efficacy and safety of oral~     antimycobacterial therapy in patients with confirmed progressive pulmonary sarcoidosis. We~     suspect that the CLEAR regimen will improve the absolute FVC percent predicted in chronic~     pulmonary sarcoidosis participants.~   "
117866|NCT02024750|"~     Children with type 1 diabetes face complex self-management regimens which make adherence~     challenging and ultimately result in poor blood sugar control. Several common barriers~     interfere with diabetes control such as limited knowledge or challenges with staying~     motivated. Efficacious strategies exist to improve diabetes self-management including, but~     not limited to, diabetes education or family therapy. Patients and families often do not~     access these strategies, in part due to healthcare systems-based issues such as~     accessibility, provider availability, or insurance coverage.~      A family-centered approach has been suggested to tailor diabetes care to provide improved~     outcomes for each child. Family-centered care engages the family in the decision-making about~     the child's health and well-being. In this study we will take a family-centered approach to~     providing diabetes self-management by identifying families' unique self-management barriers~     through a 10-minute survey tool called PRISM (Problem Recognition in Illness~     Self-Management). Based upon the results of PRISM, we will provide tailored self-management~     resources (interventions) to meet the family's needs. We will coordinate group-based delivery~     of the resources with routine diabetes clinic visits. These group-based resources will be~     delivered in four 75-minute sessions over a year.~      The primary goal of this study is to compare the effectiveness of family-centered tailoring~     of diabetes self-management resources with the untailored approach of usual care. We~     hypothesize that the family-centered model of care with tailored resources will improve the~     outcomes of glycemic control and quality of life among children with type 1 diabetes and~     their parents.~   "
117867|NCT02024737|"~     Chronic Obstructive Pulmonary Disease (COPD) is a leading and still increasing cause of~     disease and death worldwide, affecting those in both developed and developing countries. This~     imparts a massive burden of ill health, in turn imposing huge healthcare costs to society.~      For effective treatment of COPD (as opposed to providing short term relief) early disease~     must be targeted. The small airways of the lung (those less than 2mm) are the first affected~     in COPD, but current methods to assess their function are relatively insensitive. There is~     therefore a need for new, accurate methods for detection of small airway dysfunction with~     sensitivity to shortterm change and regional discrimination.~      In previous studies with hyperpolarised (HP) 3He MRI in smokers with normal pirometry and~     patients with early stage COPD, we showed sensitivity to early changes in lung ventilation~     and structure. The hyperpolarised gas MRI technique is safe. In particular, the lack of~     ionizing radiation permits patients to be imaged on multiple occasions. This and its inherent~     sensitivity to regional lung ventilation and function make it an ideal imaging tool for the~     assessment of novel lung therapies for diseases of the small airways.~      The purpose of this pilot study is to determine short and long term reproducibility of a~     comprehensive set of functional imaging data; using hyperpolarised gas MRI, conventional MRI~     and lung physiology measurements in patients with moderate to severe COPD.~      In addition,how sensitive the imaging techniques are to changes in lung function after~     treatment with a standard (bronchodilator) inhaler will also be assessed.~      This pilot study will serve as a platform for future larger scale studies, aimed at better~     understanding of and intervention in early COPD.~   "
117868|NCT02024724|"~     Trigeminal neuralgia is a craniofacial pain syndrome that is typically characterized by~     unilateral severe, recurrent, electrical pain in one or more distributions of the trigeminal~     nerve. Current treatment strategies include oral medications as first line therapy with~     surgical interventions reserved for those patients who are refractory to medications or~     unable to tolerate medication side effects. Despite these current treatment options, many~     patients continue to have symptoms. Ultrasound-guided trigeminal nerve block allows for fine~     adjustment of the needle tip and direct observation of the medicine.~      Local anesthetic and steroids have been successfully used for diagnostic and or therapeutic~     nerve pain with great success. Steroids can be short or long acting in duration with varying~     side effects. If there exists a difference in duration of action, using the longer acting~     drug will provide a greater period of symptom relief for the patient and may allow the~     patient to undergo fewer interventional procedures.~   "
117869|NCT02024711|"~     The purpose of this multicenter, prospective, randomized clinical study is to determine the~     safety and effectiveness of the EYEFILL® C.-US Viscoelastic in patients undergoing cataract~     extraction and intraocular lens (IOL) implantation surgery.~      EYEFILL® C.-US Viscoelastic is designed to create and maintain space, to protect the corneal~     endothelium and other intraocular tissues, and to manipulate tissues during surgery.~      EYEFILL® C.-US Viscoelastic may also be used to coat intraocular lenses and instruments~     during cataract extraction and intraocular lens insertion.~   "
117870|NCT02024698|"~     The objective of this study is to compare the clinical performance of ProClear 1-Day versus~     1-Day Acuvue Moist each for one week of daily disposable wear.~   "
117871|NCT02024685|"~     This is a psychosocial/behavioral study and does not involve administration of any treatment~     or diagnostic procedures. We will use a randomized trial to test the hypothesis that a~     decision analysis model that provides individualized estimates of quality-adjusted~     disease-free survival for each of the treatment options for clinically localized prostate~     cancer will lead to higher quality treatment decisions congruent with a patient's values~     leading to improved decisional regret and treatment satisfaction. In this trial, all patients~     would be evaluated at baseline for their utilities for various clinically important health~     states. The control arm will receive counseling regarding treatment options using standard~     patient-physician interactions and nomogram-predicted probabilities of treatment outcome for~     the various treatment options and they will be unaware of the decision analysis~     recommendation. The treatment arm would be counseled using standard patient-physician~     interactions and they would also be provided with a personalized treatment recommendations~     based on the decision analysis model prior to treatment selection. The primary endpoint of~     this study will be regret-free survival at 2 years after treatment. There will be a 1:1~     randomization. A random permuted design will be used to assure approximate balanced number of~     patients in the two groups over time.~   "
117882|NCT02024542|"~     Research the genetic and biomechanical markers of human adipose tissue on patients with~     morbid obesity. Additional tissue/fluid collection is also gathered during the time of~     surgery.~   "
117911|NCT02024165|"~     The specific goal of the proposed research is to develop a reliable, non-invasive fetal and~     maternal heart rate and contraction monitor that is unaffected by obesity and requires less~     nursing intervention than the tocodynamometer and Doppler ultrasound.~   "
117872|NCT02024672|"~     Intrauterine devices (IUDs) are one of the most effective reversible forms of contraception,~     and are a good option in the postpartum period for women to avoid a rapid repeat pregnancy.~     IUDs can be placed immediately postpartum, after delivery of the placenta by either vaginal~     or cesarean birth. This practice has been shown to be safe, and is recommended by the~     American College of Obstetricians & Gynecologists, the World Health Organization and the U.S.~     Center for Disease Control. Immediate postpartum IUD placement has the advantage of providing~     contraception at a time that the woman is already accessing medical care, avoiding potential~     loss to follow up or risk of unintended pregnancy. Additionally, women who have anesthesia~     for delivery have reduced pain at the time of IUD placement compared to having the IUD placed~     at the postpartum follow up appointment. Immediate postpartum IUD placement is a relatively~     new practice in the US and little is known about the expected appearance of IUDs inside the~     uterus taken with an ultrasound when they have been placed at the time of delivery. It is~     less likely that IUD strings will be visible at the cervix after immediate postpartum IUD~     placement due to subsequent uterine involution, which makes it important to monitor correct~     positioning of the IUD via ultrasound. This study will document normal changes in the~     positioning of the IUD visualized via ultrasound, and determine if a correlation exists~     between IUD position and risk of expulsion. Ultrasound surveillance to document IUD position~     and distance from the fundus, will be performed at 6 weeks, 3 months and 12 months after~     placement. Symptoms of menstrual bleeding and pain will also be recorded in order to~     determine if they are correlated with IUD position.~   "
117873|NCT02024659|"~     This randomized, double-blind, placebo-controlled clinical trial enrolled subjects with~     eosinophilic CRSwNP. Subjects were randomized to receive either budesonide inhalation~     suspension or placebo for 14 days. Visual analogue scales (VAS）of nasal symptoms, endoscopic~     polyp scores and morning serum cortical levels were assessed pre- and post-treatment. Polyp~     samples were evaluated for inflammatory cytokines, matrix metalloproteinases (MMPs) and~     tissue inhibitors of metalloproteinases (TIMPs) by immunoassay; collagen by histochemistry;~     and frequencies of different inflammatory T cell infiltration by flow cytometry. this study~     is undertaken to evaluate the efficacy of short-term prescription of budesonide inhalation~     suspension via transnasal nebulization by clinical and immunologic assessments. As outcome~     parameters for remodeling, differences in the expression of collagen and albumin were~     investigated before and after budesonide treatment. Meanwhile, TGF-β, MMPs and TIMPs~     expression differences in nasal polyps were investigated to explore underlying mechanisms of~     tissue reconstitution.~   "
117874|NCT02024646|"~     The primary objective of this study is to evaluate the efficacy of brodalumab, compared to~     placebo, in subjects with psoriatic arthritis. The key secondary objective is to evaluate the~     efficacy of brodalumab compared to placebo at week 16. The safety objective of this study is~     to evaluate the safety profile of brodalumab in subjects with psoriatic arthritis.~   "
117875|NCT02024633|"~     Research Hypothesis: icotinib administered in combination with gemcitabine has an acceptable~     safety profile in subjects with locally advanced, unresectable or metastatic pancreatic~     adenocarcinoma.The primary objective is to determine the safety profile of icotinib in~     combination with gemcitabine in subjects with locally advanced, unresectable or metastatic~     pancreatic adenocarcinoma.~   "
117876|NCT02024620|"~     Smartphone applications (apps) may be well-suited as a low cost adjunctive tool for~     increasing the adherence of individuals to psychotherapy treatments which may subsequently~     increase symptom reduction and improve clinical outcomes. Apps offer the opportunity for~     real-time tracking of behavior and have the ability to provide prompt feedback and reminders~     in a convenient, readily available technology. The immediacy and convenience of apps may be~     responsible for the observed improvements in adherence on the part of the patients relative~     to traditional paper-and-pencil tracking and practice of skills taught in psychotherapy.~     These features are relevant to behavioral activation (BA) protocols, the effects of which are~     often attenuated by failure to adhere to regular practice and tracking of behavior. The Mood~     Coach app is a BA protocol developed to provide a convenient means of planning and tracking~     activity, and monitoring mood responses to scheduled increases in activity. This project~     evaluates the utility of this app as an adjunct to standard BA treatment. The investigators~     predict that participants assigned to the BA+app condition will demonstrate greater adherence~     to the BA treatment compared to the standard BA condition. The investigators also predict~     that the participants in the BA+app condition will report greater satisfaction with the app~     compared to the standard BA protocol that utilizes paper and pencil materials.~   "
117877|NCT02024607|"~     This is an open label, multi-center, Phase 1/2 dose escalation study of BBI608 administered~     in combination with either FOLFOX6 with and without bevacizumab, or CAPOX, or FOLFIRI with~     and without bevacizumab, or regorafenib, or irinotecan.~   "
117878|NCT02024594|"~     Visiting anxious and fearful children is an inevitable prospect of the daily work of every~     dentist who treats pediatric patients. Dentists have been using a wide variety of~     non-pharmacological and some pharmacologic techniques to assist them in the management of~     children with anxiety. One strategy which seems promising for pain control in stressful~     medical situations is teaching the child to use behavioral and cognitive coping skills or a~     combination of both techniques. An alternative technique to non-pharmacologic approaches in~     children being anxious and lacking in cooperative ability is sedative technique such as~     nitrous oxide conscious sedation. As there is lack of studies comparing conscious sedation~     and combinations of cognitive-behavioral strategies in eliminating children's uncooperative~     behaviors and dental anxiety, the aim of this study was to compare the effectiveness of~     inhalation sedation with Nitrous Oxide-Oxygen conscious sedation and cognitive-behavioral~     therapy to reduce dental anxiety in preschool children.~   "
117879|NCT02024581|"~     This trial will examine the safety, tolerability and efficacy of one strength of East Indian~     sandalwood oil (EISO) in a cream base compared to a placebo for treatment of molluscum~     contagiosum in pediatric subjects. Trial participants will be asked to apply study medication~     twice a day for sixty (60) days. Efficacy will be evaluated by clinical staff and patients~     will be asked to assess tolerability as well as any improvement experienced during the trial.~   "
117909|NCT02024191|"~     Oxaliplatin is a chemotherapeutic agent, which is generally used in treatment of colorectal~     cancer. The dose limiting side effect of oxaliplatin is neurotoxicity. In this study we aimed~     to determine whether glutamine has role in prevention of oxaliplatin induced neuropathy.~   "
117883|NCT02024529|"~     This is a randomized, placebo-controlled, double-blind study in which 500 patients with~     osteoarthritis (OA) knee pain will be randomized to Ampion or placebo and followed for 20~     weeks. The clinical effects of treatment on OA pain will be evaluated during clinic visits at~     6, 12, and 20 weeks using WOMAC® osteoarthritis Index and the Patient's Global Assessment of~     disease severity (PGA). Safety will be assessed by recording adverse events, concomitant~     medications, physical examination, vital signs and clinical laboratory tests.~   "
117884|NCT02024516|"~     The aim of this study is to examine the effects of concentrated pomegranate juice on serum~     lipid profile and some inflammatory factors in patients with type 2 diabetes. Forty patients~     aged between 25-60 years old from both sexes are recruited. Patients consume 50gr/day~     concentrated pomegranate juice for 4 weeks. Anthropometric and blood pressure measurements,~     3-days food-record questionnaire ,physical activity and fasting blood samples were collected~     at the beginning and at the end of the study. Fasting blood sugar, lipid profile, TNF- a,~     IL-6,hs -CRP and adiponectin levels are measured. LDL are calculated by formula. The~     participants are asked not to change their regular diet, medicine and activity during the~     study.~   "
117885|NCT02024503|"~     Imaging of the ischaemic penumbra with a particular diffusion-weighted imaging (DWI)/~     perfusion-weighted imaging (PWI) mismatch is a promising approach to the selection of~     patients with acute ischaemic stroke for trials of intervention. The investigators want to~     apply multimodal resonance imaging methods such as functional magnetic resonance imaging (~     fMRI), diffusion tensor imaging (DTI), arterial spin labeling (ASL) to guide treatment and~     predict the prognosis of stroke.~   "
117886|NCT02024490|"~     Respiratory distress syndrome (RDS) of the newborn, also called as hyaline membrane disease,~     is the most common cause of respiratory distress in premature infants, correlating with~     structural and functional lung immaturity. The pathophysiology of RDS is complex. Immature~     type II alveolar cells produce less surfactant that causes an increase in alveolar surface~     tension and a decrease in compliance. This resultant atelectasis lead to pulmonary vascular~     constriction, hypoperfusion, and lung tissue ischemia. RDS and prolonged ventilation and~     associated systemic/lung injury may also contribute to long term oxygen dependency and may~     result in bronchopulmonary dysplasia (BPD). Vitamin D is a fat-soluble steroid hormone that~     primarily contributes to the maintenance of normal calcium homeostasis and skeletal~     mineralization. In addition to its classical role in bone metabolism, vitamin D deficiency~     has been associated with impaired pulmonary function, increased incidence of viral and~     bacterial infections and inflammatory lung diseases. Although exact mechanisms are not fully~     understood, vitamin D appears to impact on a variety of inflammatory and structural cells~     within the lung including macrophages, lymphocytes and epithelial cells. To our best of~     knowledge, no study has evaluated the effect of vitamin D levels on the severity and presence~     of RDS in preterm infants. Therefore, the aim of this study is to evaluate the possible role~     of maternal/neonatal vitamin D levels on RDS development in preterm infants. We also aim to~     determine the possible association between maternal/neonatal vitamin D levels and the~     incidence of BPD and other neonatal morbidities.~   "
117887|NCT02024477|"~     Type 2 diabetes is a national epidemic. Diabetes has undesirable effects on blood vessels~     which may contribute to heart disease. Endothelial Progenitor Cells(EPCs) are found in the~     blood . Research has shown that improving the survival of these special blood cells may~     decrease the harmful effects of diabetes on blood vessels and reduce or reverse heart~     disease. Saxagliptin is an FDA(Food and Drug Administration) approved prescription medicine~     used along with diet and exercise to lower blood sugar in people with Type 2 diabetes. It is~     in a class of diabetes medication called DPP-4 inhibitors. DPP-4 inhibitors have been shown~     to increase EPCs in patients with Type 2 diabetes.~      Hypothesis: We believe poor viability and function of EPCs in early diabetes ultimately~     affects the repair and regeneration of the endothelium and that prompt intervention using~     saxagliptin with another oral hypoglycemic agent, Metformin, may reduce or reverse~     cardiovascular risk by improving EPC survival and function above and beyond adequate glucose~     metabolism control.~   "
117888|NCT02024464|"~     This clinical trial compares two implantable devices intended to lower the pressure inside~     the eye of glaucoma patients. One of the two devices will be implanted immediately following~     cataract surgery and the placement of a posterior chamber intra-ocular lens.~   "
117889|NCT02024451|"~     Myofascial pain syndrome is common in Rehabilitation clinic. The pain occurs asymmetrically~     in isolated or regional muscles, and is associated with acute muscle strain or chronic muscle~     overuse. Myofascial pain is characteristics with localized muscle tenderness, palpable~     intramuscular taut band, typical referred pain, and local twitch response.~      Treatment of myofascial pain syndrome includes physical therapy, stretch exercise, dry needle~     insertion and trigger point injection. Acupuncture originated from ancient Chinese medicine~     which involves the insertion of fine needle to stimulate specific points of the body along~     the 12 meridians. The mechanism of pain relief may be initiated by activation of both spinal~     segmental and supraspinal centers. Acupuncture is commonly used for pain relief.~      Recently, radial shock wave has been shown to be effective in the treatment of chronic~     musculoskeletal pain, including calcific tendinitis, epicondylitis, and plantar fasciitis.~     The energy and pressure produced by radial shock wave is focused on the treated~     musculoskeletal tissue. The mechanism of action has been hypothesized that the energy could~     result in analgesic effect and stimulation of angiogenesis and healing response and then~     relief of the symptoms. The effectiveness of radial shock wave on treatment of myofascial~     pain was reported by Jeon and colleagues in 2012.~      The aim of this study is to compare the efficacy of acupuncture and radial shock wave therapy~     in patients with myofascial pain syndrome.~   "
117890|NCT02024438|"~     For gastric patients of Karnofsky scores between 60-80 scores, mFolfox6 is an option for~     chemotherapy. Neutropenia and oxaliplatin-induced neurotoxicity are the most common adverse~     effects which even result in discontinue of chemotherapy, especially for patients suffered~     from heavily acute neurotoxicity. Monosialotetrahexosylganglioside is a component of membrane~     of nerve cells. Previous phase II clinical trial showed, it can reduce oxaliplatin-induced~     neurotoxicity(OIN). But it did not certificated by phase III trial. A phase III trial is~     needed to investigate the effect and safety of monosialotetrahexosylganglioside Sodium~     Injection for prevention OIN at gastric cancer.~   "
117891|NCT02024425|"~     The purpose this study is to evaluate the therapeutic effect of a functional bioactive~     supplement associated with a hypocaloric equilibrated diet to treat obese and overweight~     individuals. The functional bioactive supplement, containing antioxidant extracted from~     rosemary, oligosaccharides derived from lactulose and bioactive peptides, was developed to~     satiety control, improves of anti-inflammatory response and antioxidant defense mechanisms as~     well as to weight loss.~   "
117892|NCT02024412|"~     The morbidity of colorectal cancer(CRC) is 10%～15% in China.mFolfox6 has become one of the~     standard regimes for metastatic colorectal cancer (mCRC). Neutropenia and oxaliplatin-induced~     neurotoxicity are the most common adverse effects which even result in discontinue of~     chemotherapy, especially for patients suffered from heavily acute neurotoxicity.~     Monosialotetrahexosylganglioside is a component of membrane of nerve cells. Previous phase II~     clinical trial showed, it can reduce oxaliplatin-induced neurotoxicity(OIN). But it did not~     certificated by phase III trial. Investigators designed the phase III trial to investigate~     the effect and safety of monosialotetrahexosylganglioside Sodium Injection for prevention OIN~     at colorectal cancer.~   "
117893|NCT02024399|"~     This project will address the important area of childhood obesity and the risk of~     cardiovascular disease associated with obesity. This is a serious health concern since~     children who are overweight or obese are prone to other medical conditions including high~     blood pressure, abnormal lipid profiles,and type 2 diabetes. Although exercise and nutrition~     programs are recommended, evidence for the efficacy of these programs in improving~     cardiovascular health is lacking.~      Specific Aims: a) improve cardiovascular risk factors, b) increase physical fitness levels,~     c) improve lean body mass, d) enhance QOL of the child e) influence adherence rates to~     exercise and a healthy lifestyle change both during and beyond the conclusion of the program.~      Hypothesis 1a: Compared to baseline and matched controls, children randomized to a 10 week~     multidisciplinary fitness and nutrition program will show significant improved levels of~     cardiovascular risk factors.~      Specific Aim 2: To determine if a multidisciplinary fitness and nutrition program, when~     compared with a matched, WLC group will show a change in whole body assessment including a~     decrease in fat mass, an increase in percent lean body mass, and a decrease in percent body~     fat, as measured utilizing dual-energy X-ray absorptiometry Hypothesis 2a: Compared to~     baseline and matched controls, children randomized to a 10 week multidisciplinary fitness and~     nutrition program will show improved whole body assessments including.~      Specific Aim 3:To determine if a multidisciplinary fitness and nutrition program, when~     compared with a WLC group will show improved levels of fitness. Hypothesis 3a: Compared to~     baseline and matched controls, children randomized to a 10 week multidisciplinary fitness and~     nutrition program will show significant improvements in fitness including.~   "
117894|NCT02024386|"~     During ascent to high altitude there is a physiologic response to hypoxia that results in an~     elevated pulmonary arterial pressure associated with decreased exercise performance,~     altitude-induced pulmonary hypertension, and high altitude pulmonary edema (HAPE). Riociguat~     is a novel agent from Bayer Pharmaceuticals that has already demonstrated effectiveness in~     the treatment of pulmonary hypertension, and it may prove to be beneficial in cases of~     altitude-induced pulmonary hypertension or HAPE. This research study, composed of 20 healthy~     volunteers ages 18-40 years, will attempt to mimic the decreased oxygen supply and elevated~     pulmonary artery pressures found in conditions of high altitude, allowing observation of the~     effects of riociguat and exercise on pulmonary arterial pressure, arterial oxygenation, and~     exercise performance. Prior to entering the hypobaric chamber, subjects will have radial~     arterial lines and pulmonary artery catheters placed to obtain arterial and pulmonary artery~     pressure measurements. Subjects will then enter the hypobaric chamber and perform exercise~     tolerance tests at a simulated altitude of 15,000 feet on an electrically braked ergometer~     (exercise bike) before and after administration of riociguat. If, after administration of~     riociguat and exposure to a simulated altitude of 15,000 feet, the exercise performance is~     improved and observed pulmonary artery pressures are lower than those measurements seen prior~     to administration of riociguat, this could lead to development of a prophylactic and/or~     treatment strategy for HAPE and high-altitude pulmonary hypertension. Statistical analysis~     will compare the variables of pulmonary artery pressure, radial arterial pressure,~     ventilation rate, cardiac output, PaO2, and work rate at exhaustion before and after~     administration of the drug riociguat. The investigator's hypothesis is that riociguat will~     decrease pulmonary artery pressure and improve gas exchange and exercise performance at~     altitude.~   "
117895|NCT02024373|"~     To evaluate the clinic effects and security of oral administration of Atorvastatin on chronic~     subdural hematoma (CSDH).~   "
117896|NCT02024360|"~     The purpose of this research is to investigate the effectiveness of a community health~     worker-based program as an adjunct to clinical services regarding childhood obesity~     management. This family-centered program will be delivered in the community and homes of~     enrolled families. The primary outcome will compare change in age-gender specific~     body-mass-index (BMI) z-score (zBMI) over time. All Denver Health children and families will~     be enrolled at study inception and receive the intervention in 1 of 5 defined 6-month stepped~     wedge engagements. The intervention lasts for 6 months and the time prior to engagement in~     the intervention will serve as the control period. Intervention construct validity will be~     evaluated using data on diet, activity, and fitness. The primary goal is to examine the~     effect of the intervention in reducing the zBMI in the index patient and secondarily on any~     participating family members. We will test effectiveness among demographic groups~     under-represented in prior studies, including very young children and Latinos. Results from~     this study will inform future intervention modifications and permit effect size estimation~     and power calculations for future randomized trials that include a community health~     worker-based obesity prevention and treatment program. During the course of the study, an~     obesity registry will be designed and implemented within an integrated safety-net healthcare~     system to measure primary obesity outcomes in a low-income population and conduct analyses.~     The community health worker will be using several new technologies (e.g., text messaging and~     patient relationship manager [PRM]) as an adjunct when working with an obese child and~     his/her family. Targeted training for clients, providers and CHW will be part of the~     prevention strategies implemented during the grant period, these will include motivational~     interviewing. All of these (i.e., obesity registry, technologies and training) will have an~     evaluative component.~   "
117897|NCT02024347|"~     Liver cirrhosis is an advanced stage of chronic liver diseases, which is often associated~     with various complications, namely esophageal and/or gastric varices, ascites, hepatocellular~     carcinoma (HCC). It is well known that the risk of complications varies even among cirrhotic~     patients, as those with more advanced disease would have more complications and poorer~     survival rates. Liver stiffness measurement (LSM) with transient elastography is found useful~     to identify cirrhotic patients with higher risk of portal hypertension and presence of~     varices . Recently, spleen stiffness measurement (SSM) with the same machine was found~     accurate to predict portal hypertension and esophageal varices.~      Investigators hypothesized that a new screening strategy guided by LSM and SSM (LSSM) values~     (LSSM-guided) is non-inferior to conventional strategy in terms of detection rate of~     clinically significant esophageal and/or gastric varices for patients with liver cirrhosis in~     an open-labeled randomized controlled trial.~      Consecutive patients with compensated liver cirrhosis will be invited for the study. Patients~     fulfilling the study criteria will be randomized into LSSM arm (upper endoscopy only~     performed to patients with high LSM or SSM values), and control arm (upper endoscopy~     performed to all patients). Patients randomized into LSSM arm will undergo transient~     elastography examination; those with high LSM or SSM results will be referred for upper~     endoscopy examination for to screen varices. Patients randomized into control arm will be~     directly referred for upper endoscopy examination.~   "
117898|NCT02024334|"~     A randomized double blind clinical trial to assess efficacy of leflunomide in treatment of~     refractory juvenile idiopathic arthritis.~      Patients are randomly divided into two groups. In group 1 leflunomide and in group 2 placebos~     will be added to conventional treatment for three months. therapeutic responses will be~     evaluated by ACRpedi (American College of Rheumatology Pediatric) scores every 4 weeks.~   "
117899|NCT02024321|"~     The purpose of this study is to determine the relationship among TPN, tumor and blood~     glucose.~   "
117900|NCT02024308|"~     The purpose of the study is to determine whether Fludarabine in combination with cytarabine~     is more effective than high-dose cytarabine in post-remission therapy for patients with~     AML1-ETO acute myeloid leukemia.~   "
117901|NCT02024295|"~     To determine the efficacy and safety S-adenosyl-l-methionine in alcoholic hepatitis with~     cholestasis.~   "
117902|NCT02024282|"~     Acute illness is the most common presentation of children attending ambulatory care settings.~     Serious infections (e.g. meningitis, sepsis, pyelonephritis, pneumonia) are rare, but their~     impact is quite large (increased morbidity, mortality, induced fear in parents and defensive~     behaviour in clinicians). Early recognition and adequate referral of serious infections are~     essential to avoid complications (e.g. hearing loss after bacterial meningitis) and their~     accompanied mortality. Secondly, we aim to reduce the number of investigations, referrals,~     treatments and hospitalisations in children who are diagnosed with a non-serious infection.~     Apart from the cost-effectiveness, this could lead to less traumatic experiences for the~     child and less fear induction for the concerned parent. Finally, we aim to support the~     clinicians to rationalise their antibiotic prescribing behaviour, resulting in a reduction of~     antibiotic resistance in the long run.~   "
117903|NCT02024269|"~     This will be an open-label, non-randomized multi-center study of adipose stem cell (ASC)~     implantation. ASCs will be derived from the patient's adipose or fat. Liposuction using local~     anesthesia and syringe collection will be performed to collect the adipose tissue specimen~     for subsequent processing to isolate the stem cells. The cells will be delivered via needle~     injection into the eye.~   "
117904|NCT02024256|"~     The purpose of this study is to compare the impact of treatment with cooled magnesium sulfate~     and cold water-soaked pads on perineal pain and swelling following vaginal delivery.~      Assessment of appropriateness for each patient to take part in the study will be performed~     approximately 2 hours following delivery. Those patients who consent to participate in the~     trial will be allocated to treatment groups in a double-blinded, randomized manner. Women in~     the study group will receive treatment with pads soaked in a cold aqueous solution of~     magnesium sulfate at 33% (w/v) concentration, while those in the control group will receive~     treatment with pads soaked in cold water.~      Nurses will initiate treatment according to the group to which the patient was randomized.~     Said pads will be given the patients routinely 5 times a day at regular times.~      A physician will assess the perineal swelling according to visual (photographed) scale in~     which severe, moderate, light and no swelling will be defined. Measurement of swelling in~     centimeters (maximal length and breadth); photography, by a medical photographer or the~     examining doctor, of the perineal area with a centimeter ruler, before, during and after~     treatment (photography is dependent on patient approval and is not a precondition to~     participation in the trial.); and additional examination, on the above basis, will be~     performed regarding hemorrhoids in the event that a patient has complained of such.~      A nurse will assess the perineal pain and swelling on a scale ranging from 0 to 10 prior to~     the patient being given the pad and an hour following treatment. An additional assessment by~     the same method will be performed regarding hemorrhoid pain. Any analgesia administered will~     also be recorded.~      Likewise, for follow-up purposes a blood test for serum magnesium concentration will be taken~     before and after treatment.~      Period of follow-up will be 48-72 hours from childbirth.~   "
117905|NCT02024243|"~     Hypothesis: Elevated miR210 in the epidermis (outer layer of skin) of ischemic human wound~     edge tissue (tissue that has a lack of blood flow to it) is associated with poor healing~     outcome in a setting of standard clinical care.~      Aim of the study: To determine whether elevated miR-210 in the epidermis of ischemic human~     wound edge tissue is associated with poor healing outcome in a setting of standard clinical~     care.~      This study will last 14 weeks. Adult patients, who are non-diabetic or tightly controlled~     diabetic, and, who have chronic venous leg ulcers, that are not infected and have been~     open/not healed for at least 12 weeks, will be enrolled in this study. Patients will be~     recruited from the OSU Wexner Medical Center Comprehensive Wound Center (CWC). On days 0, 14~     and 28, patients will have the following performed: measurements and photographs taken of~     their wound; TCOM (transcutaneous oxygen measurement) or ABI to measure the amount of oxygen~     in the wound tissue; and two 3-mm punch biopsies from the same wound/ulcer. Biopsies will not~     be taken if the wound has closed by day 14 or day 28. Additionally, patients' medical records~     will be reviewed throughout the study to obtain information about the patient (age, sex,~     race/ethnicity, current medications, TCOM, would location and type, other illness/diagnoses,~     wound care treatment and instructions, nutritional status based on albumin levels), and at 14~     weeks after enrollment to determine the final status of the wound (healed or not healed).~      There will be a total of 5 visits for this study (6 total visits for patients with open~     wounds on day 28 of the study). Visits will occur on days 0, 7, 14, 21 and 28.~   "
117906|NCT02024230|"~     Antiplatelet therapy is indispensable for the prevention of stent thrombosis in patients who~     underwent coronary artery stenting. Similarly, anticoagulant therapy is essential for the~     prevention of cardiogenic embolism including cerebral infarction in AF patients. However, the~     combined antithrombotic therapy has been reported to increase the risk of major bleeding for~     AF patients after coronary stenting, New anticoagulant drugs that hardly interact with other~     drugs and do not need frequent blood tests have become commonly used. The purpose of this~     study is to assess the hypothesis that Rivaroxaban is non-inferior to Warfarin in the~     efficacy and safety for AF patients after coronary stenting.~   "
117907|NCT02024217|"~     To investigate the feasibility, safety and tolerability of Preoperative Chemoradiation in~     Patients With Localized Gastric Cancer. Primary endpoint: R0 resection rate. Secondary~     endpoint: resection rate, pathological complete regression (pCR), effectiveness and safety of~     regime, disease free survival(DFS) and overall survival(OS).~   "
117908|NCT02024204|"~     The purpose of this study is to understand why patients in the World Trade Center program~     have continuing breathing problems. This study will improve investigators understanding of~     breathing problems among individuals with World Trade Center exposure by allowing them to~     review and monitor medication use, lung function, and examine other conditions that can~     contribute to problems with breathing. The findings from the study will help investigators~     understand why some people have persistent lower respiratory symptoms (breathing problems)~     after their exposure to World Trade Center dust and fumes, and may help guide better~     management and treatment of these symptoms.~   "
118741|NCT02013323|"~     The present clinical trial was designed to investigate the clinical and microbiological~     effectiveness of systemic ayurvedic immunomodulator Septilin as an adjunct to scaling and~     root planing (SRP) in the treatment of chronic periodontitis (CP)~   "
117914|NCT02024126|"~     Osteoarthritis (OA) is one of the most common form of chronic diseases in the adult~     population, and approximately 800 000 people in Sweden (population of 9 million people)~     suffer from this disease, which causes joint pain, stiffness, swelling, loss of function and~     sick leave. There is increasing evidence that exercise therapy is effective for patients with~     knee OA. However, there is little knowledge on long-term effects and what type of exercises~     dosage is most effective. In this present clinical trial, which is a Nordic collaborative~     project with researchers from different research groups in Sweden and Norway, we intend to~     investigate short and long-term effects comparing high dosage exercise therapy (each~     treatment lasting 80 to 90 min) vs. a relatively low dosage exercise program (25 to 30 min)~     in patients diagnosed with knee OA. Patients in both intervention groups receive three~     treatments a week for 12 weeks making a total of 36 treatments. Primary outcome is~     pain-ratings and function (The Knee Injury and Osteoarthritis Outcome Score (KOOS)).~     Secondary outcome concerns various health-ratings and objective functional tests. Regarding~     predictors for outcome, we plan also to investigate different psychosocial variables as well~     as patient's beliefs regarding exercise.~      Patients are being assessed by blinded assessor at inclusion, at end of intervention (3 mo),~     and at six and 12 mo after end of treatment. We plan to include a total of 200 subjects from~     primary health care settings, two in Norway and two in Sweden, with radiographic-verified~     knee OA with knee pain and decreased function. The patients have to be within the 45 to 85~     age group. Patients are excluded if they have been scheduled for knee surgery or have some~     other form of illness/disease that limits the exercise tolerance (e.g. heart disease or~     systemic/metabolic diseases or chronic obstructive airways disease). A major goal is to grade~     exercises so that they are performed pain-free or close to pain-free in both intervention~     groups. The principle of deloading is used to meet this goal using a high number of~     repetitions in sets as pain modulation. The results from this study will give new information~     about the effectiveness of graded exercise therapy in patients with knee OA, and new~     knowledge if outcome can be related to the exercise dosage performed.~   "
117915|NCT02024113|"~     Lung cancer is the most common cancer in men and the fourth most common cancer in women~     worldwide. Until today no effective method permits the early detection of lung cancer.~     Consequently, lung cancer is often diagnosed owing to symptoms of advanced disease. To~     address this problem, detection methods with an improved sensitivity and specificity are~     urgently needed.~      Over the past decade, accumulating evidence shows that the metabolism of cancer cells differs~     from that of normal cells. More specifically, the entire metabolism of cancer cells is~     reorganized or reprogrammed to increase anabolic reactions that induce cell growth and~     survival. Metabolic reprogramming during the development of cancer is driven by aberrant~     signaling pathways due to the activation of oncogenes and the loss of tumor suppressor genes.~     Furthermore, the microenvironment of the tumor plays a role in metabolic reprogramming. The~     altered cancer metabolism is characterized by an increased glycolysis, the production of~     lactate and the biosynthesis of macromolecules, such as proteins, lipids and nucleotides.~     Cancer cells have a high glycolytic rate and eliminate most of the glucose-derived carbon as~     lactate rather than oxidizing it completely via oxidative phosphorylation, a phenomenon known~     as the Warburg effect. The breakdown of glucose and other nutrients leads to a high energy~     production and provides the Krebs cycle with intermediates, which consequently are allocated~     to metabolic pathways that support biosynthesis. Metabolites are the end products of cellular~     metabolism and are therefore closely related to the observed phenotype. Disturbances in~     biochemical pathways which occur during the development of cancer consequently provoke~     changes in the metabolic phenotype. As a result, low-molecular weight metabolites are very~     attractive biomarkers for different cancer types. Nuclear magnetic resonance (NMR)~     spectroscopy enables the identification and quantitative analysis of complex mixtures of~     metabolites, as in plasma and serum, without an extended sample preparation.~      The present study aims to determine the metabolic phenotype of lung cancer by means of proton~     (1H)-NMR spectroscopy. Once the phenotype determined (training cohort), this has to be~     validated by an independent cohort.~   "
117916|NCT02024100|"~     The study is to identify the effectiveness of Eprosartan on pulse pressure in hypertensive~     patients with metabolic syndrome~      -Definition of pulse pressure (PP): Difference between systolic and diastolic blood pressure~     produced one heart beat.~   "
117917|NCT02024087|"~     The purpose of this study is to evaluate the safety and tolerability of dalantercept plus~     sorafenib in patients with advanced hepatocellular carcinoma (HCC) to determine the~     recommended dose level of dalantercept in combination with sorafenib.~   "
117918|NCT02024074|"~     The objective of this study is to evaluate the usefulness of Tc-99m Sestamibi Molecular~     Breast Imaging as an imaging modality for breast cancer screening.~      Tc-MBI has shown significantly higher sensitivity and equivalent specificity in the detection~     of breast cancer among high risk women when compared to mammography. However, there is little~     published data comparing Tc-MBI to MRI for evaluating extent of disease in women with known~     breast cancer.~      The study will target twenty (20) women with newly diagnosed breast cancer who are scheduled~     to undergo biopsy of additional suspicious lesions that were identified on standard of care~     contrast- enhanced breast MRI. Prior to the biopsy, these subjects will receive a Tc-MBI scan~     of the breast. The results from both imaging methods will be compared to histological~     findings. These results may be used to design larger and more comprehensive studies with an~     overarching goal to determine if there is a role for Tc-MBI in the pre-operative evaluation~     of patients with known breast cancer.~   "
117919|NCT02024061|"~     The purpose of this study is to analyse if a multidisciplinary approach including peers is~     effective in the treatment of obesity in adolescence.~   "
117920|NCT02024048|"~     The purpose of this study is to evaluate choroidal thickness and volume during the third~     trimester of pregnancy by comparison with a group of age-matched non-pregnant healthy group~     of women~   "
117921|NCT02024035|"~     The purpose of this study is to do health economic evaluation of tomotherapy and dynamic~     arctherapy (2 techniques exist: RapidArc and Vmat).~      This study evaluate also local disease control after 18 months in patients with an ENT~     epidermoid carcinoma and treated by tomotherapy orarctherapy .~      The number of patients required in this study is: 300:~        -  Number of patients treated with tomotherapy: 120~        -  Number of patients treated with dynamic arctherapy RapidArc: 120~        -  Number of patients treated with dynamic arctherapy Vmat: 60~      This is a prospective; multicentric and non randomized study.~   "
117922|NCT02024022|"~     This study aims to compare a standard approach to bowel preparation for colonoscopy (using~     sodium picosulphate/magnesium citrate or 4lPEG) to an individualized approach where patients~     are assigned a specific regimen of either sodium picosulphate/magnesium citrate or 4lPEG~     depending on patient-related factors. The study aims to compare patient-related outcomes such~     as comfort levels during bowel cleansing and physician-related outcomes such as bowel prep~     quality in the two study groups.~   "
117939|NCT02023801|"~     This is a clinical study without a formal hypothesis. The primary objective of the study is~     to evaluate the use of the Aurora Endometrial Ablation System in achieving a return to normal~     menstrual blood loss at 12 months post-treatment, in premenopausal women with menorrhagia due~     to benign causes for whom childbearing is complete or no longer wish to retain fertility.~   "
117940|NCT02023788|"~     This is a 5-year long-term follow-up study of open label, single-center, phase I clinical~     trial to evaluate the safety and efficacy of PNEUMOSTEM® in premature infants with~     bronchopulmonary dysplasia.~   "
117941|NCT02023775|"~     Prospective, longitudinal, open-label, multicentre, observational, non-comparative national~     study using an exhaustive registry of implantations over a given period.~      This study is requested by French Health Authorities for reimbursement renewal, to maintain~     reimbursement for pulmonary valvular replacement by bioprothesis in approved indication in~     France.~   "
117923|NCT02024009|"~     This study will evaluate the role of increasing radiotherapy dose and addition of nelfinavir~     to chemoradiotherapy (CRT) in patients with inoperable pancreatic cancer that has not spread~     beyond the pancreas.~      Currently in the United Kingdom (UK), either chemotherapy alone or chemotherapy followed by~     CRT can be used in the management of inoperable pancreatic cancer that has not spread. CRT~     consists of 25-30 radiotherapy treatments in combination with chemotherapy. Although this~     treatment is effective in controlling local symptoms and slowing down the pace of cancer, in~     most cases it is unable to shrink it enough to make it operable. Some of the reasons for this~     could be the lack of oxygen and lack of blood flow within the tumour making it resistant to~     the effects of CRT. This study will investigate whether increasing the dose of radiotherapy,~     or increasing the oxygen and blood supply to the tumour by giving nelfinavir, or a~     combination of both, can improve outcomes. We also want to know what the additional~     toxicities from such intensive approaches are.~      All participants will initially receive 12 weeks of chemotherapy, and those with stable or~     responding disease will receive further study treatment. The treatment allocation to 1 of the~     5 options outlined below will be done at random by computer and neither the doctor nor the~     patient can choose the treatment option. The process of randomisation ensures that all~     treatment arms are equally balanced in terms of patient and tumour characteristics, and to~     reduce the possibility of bias.~      The study will consist of 2 stages. In the 1st stage we aim to find the right dose of~     nelfinavir to combine with CRT, and this will require around 27 participants of whom up to 18~     will receive nelfinavir together with CRT. In the 2nd stage, we want to find out the benefits~     of this approach over and above standard treatments and therefore we will recruit the order~     of 262 participants and allocate 170 to 1 of the 5 following treatment arms:~      Arm A: Nelfinavir together with CRT Arm B: CRT (without nelfinavir) Arm C: Nelfinavir~     together with CRT (but using a higher than conventional dose of radiotherapy) Arm D: CRT~     without nelfinavir (but using a higher than conventional dose of radiotherapy) Arm E:~     Chemotherapy alone (without radiotherapy) Participants who are ineligible or refuse~     randomisation will be treated as per local standard but will remain in the study for follow~     up at 26, 39 and 52 weeks. Their data will contribute to an Overall Survival (OS) analysis.~   "
117924|NCT02023996|"~     This study is divided into two groups. The purpose of the first group (Group 1) was to find~     the optimal time for taking pictures after injection of 89Zr-DFO-trastuzumab, to see how long~     it stayed in the blood, and to see how well it was tolerated. From what the investigators~     have learned from Group 1, patients in Group 2 no longer need serial scans or serial blood~     draws.~      For Group 2, the patient will receive the injection of 89Zr-DFO-trastuzumab and will be~     monitored following the injection. The patient will be asked to return for a picture 5-8 days~     after injection to determine how well the study drug attaches to your tumor and how well it~     is tolerated~   "
117925|NCT02023983|"~     The aim of the study is to prove that early discharge (within 72 hours) in selected group of~     patients after myocardial infarction with elevations of ST-segment is feasible and safe~   "
117926|NCT02023970|"~     Cardiac valve disorders are widely spread in the general population and represents the third~     most frequent cardiovascular illness after coronary disease and arterial hypertension. In~     this context, aortic valve stenosis (the central pathology in this project) is the most~     common form of valve disease. Cardiac valve replacement is in the vast majority of cases the~     first line therapy for degenerative heart-valve diseases. These are represented by mechanical~     and bioprosthetic valve (BHV). In the vast majority of cases, BHV are derived from animals~     and from a biological standpoint are classified as xenografts. BHV are severely penalised by~     a premature structural damage, with ultimate valve failure occurring around 10 years after~     surgery in 5 to 30% of cases, depending on the type of BHV used. Several factors [including~     dyslipidaemia, gender, valve position] may contribute to the ultimate failure of the BHV and~     there has been increasing evidence recently of a substantial immune reaction elicited by the~     implanted BHV. This immune response is still poorly understood. It may lead to adverse immune~     reactions and this will be thoroughly investigated by the TRANSLINK team. In this light, the~     TRANSLINK project aims to provide the necessary data to demonstrate beyond any reasonable~     doubt the central role of the anti-BHV immune response in the premature failure of BHV and to~     provide efficient strategies to enable safe implantation of BHV valves in currently~     unsuitable candidates~   "
117927|NCT02023957|"~     The current protocol pertains to the evaluation of the interactive computer-assisted~     screening (iCAS) tool through a pilot randomized control trial. The purpose of this~     evaluation is to determine the efficacy of the iCAS tool in improving clinician's detection~     of common mental health conditions (i.e. major depression/generalized anxiety/post-traumatic~     stress disorder/alcohol dependence), and patients' discussion on mental health.~   "
117928|NCT02023944|"~     Interventions aimed at disseminating information about cognitive aging and lifestyle factors~     that contribute to successful cognitive aging, in addition to providing broad cognitive~     skills training, may improve the psychological wellness and day-to-day functioning of the~     aging Veteran population. This 12-week course aims to teach older Veterans (age 50+) about~     brain aging, lifestyle factors that contribute to successful aging, and techniques that can~     boost cognition in daily life.~   "
117929|NCT02023931|"~     A pilot study has been designed to determine (primary objective) if three brief interventions~     with three oral BSE regimens will alter mRNA biomarkers of Nrf2 pathway signaling, including~     NQO1, GSTs and AKRs, in the oral mucosa of healthy subjects. Quantitative distribution data~     and preliminary effect size for specific Nrf2 targets, as measured in serial buccal cell~     scrapings, will be determined during the course of 3-day exposures to three BSE regimens.~     These data will inform the design of a randomized, phase II chemoprevention trial in patients~     with HPV-negative HNSCC.~      Ten healthy volunteers will be recruited for this pilot study, Age ≥ 18 years, both male and~     female: 1) The non-cancer population presenting to the University of Pittsburgh Eye and Ear~     Institute or the Hillman Cancer Center. This may include patients with benign disease or~     their friends/family members, or friends/family members of patients with cancer; 2)~     Professionals, staff, or students at the University of Pittsburgh.~   "
117930|NCT02023918|"~     Growth hormone is well known to cause changes in glucose regulation. People with Laron~     syndrome are born without the growth hormone receptor and are protected from diabetes. Mice~     who are engineered without the growth hormone receptor are similarly protected from diabetes.~     Conversely, people who have excessive amounts of growth hormone, such as patients with~     acromegaly, have an increased risk for type 2 diabetes. In acromegaly patients, treatment~     with pegvisomant, a medication that reduces insulin like growth factor-1 by blocking the~     growth hormone receptor, significantly improves insulin resistance. Pegvisomant has not been~     explored as a possibility for the treatment of type 2 diabetes or insulin resistance in~     people without acromegaly. In this study, the investigators hope to study the metabolic~     effects of pegvisomant on people who have insulin resistance but not diabetes. Pegivosmant is~     expected to improve insulin resistance in the liver, fat and muscle as well as decrease serum~     free fatty acids.~   "
117951|NCT02023645|"~     Past research suggests that retinal lutein levels are related to cognitive function as~     measured via behavioral tests. The goal of the present study is to investigate the~     relationship between lutein and cognitive function in a wider variety of the population~     (young, healthy adults and older adults), using a wider variety of methods (behavioral~     testing and neuroimaging).~   "
117931|NCT02023905|"~     The purpose of this study is to find out what effects, good and/or bad, everolimus (RAD001,~     also known as Afinitor®) alone or with temozolomide has on the patient and the patient's~     low-grade glioma. Everolimus is being investigated as an anticancer agent based on its~     potential to prevent tumor cells from growing and multiplying. Specifically, there is a~     protein called mTOR that we think helps many tumors to grow, and everolimus blocks the effect~     of mTOR. Temozolomide is also an anticancer agent that prevents tumor cells from growing and~     multiplying. About 159 people total will take part in this study. Patients will be assigned~     to one of three treatment groups depending on the results of some tests done on their tumor.~     Each group will have 53 patients in it. 2 groups will receive treatment with everolimus~     alone, while the third group will receive treatment with both everolimus and temozolomide. In~     this study, patients will be assigned to one of 3 treatment arms based on two characteristics~     of their tumor, called 1p/19q (this is a test of the tumor chromosomes) and p-PRAS40~     (this is a test of a pathway in the tumor called mTOR). If the patient's tumor is 1p/19q~     intact and p-PRAS40 positive, the patient will be assigned to Treatment Arm 1, and the~     patient will receive everolimus alone. If the patient's tumor is 1p/19q intact and p-PRAS40~     negative, the patient will be assigned to Treatment Arm 2 and the patient will receive~     everolimus and temozolomide. If the patient's tumor is 1p/19q co-deleted, regardless of the~     p-PRAS40 result, the patient will be assigned to Treatment Arm 3, and the patient will~     receive everolimus alone.~   "
117932|NCT02023892|"~     Healthy subjects take single dose of 80mg atorvastatin, then measured their circulating~     endothelial microparticles and flow-mediated vasodilation in the brachial artery by~     ultrasound at different time points.~   "
117933|NCT02023879|"~     Primary Objective:~      To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by a regimen of~     alirocumab including a starting dose of 150 mg every 4 weeks (Q4W) as add-on to non-statin~     lipid modifying background therapy or as monotherapy in comparison with placebo in~     participants with primary hypercholesterolemia not treated with a statin.~      Secondary Objective:~        -  To evaluate the effects on other lipid parameters of alirocumab 150 mg Q4W versus~          placebo.~        -  To evaluate the safety and tolerability of alirocumab 150 mg Q4W.~      Alirocumab 75 mg Q2W was added as a calibrator arm.~   "
117934|NCT02023866|"~     To evaluate safety, tolerability and efficacy of cysteamine bitartrate delayed-release~     capsules (RP103) administered up to 1.3 g/m²/day in two divided doses, every 12 hours, for up~     to 6 months in patients with inherited mitochondrial disease.~   "
117935|NCT02023853|"~     20 consecutive adult implant patients, presenting the signs of peri-implant mucositis~     (probing depth ≥4 mm combined with bleeding and/or pus on probing) or initial~     peri-implantitis (probing depth ≥4 mm, bleeding and suppuration plus radiographic loss of~     supporting bone ≤30% compared with the situation after implant placement) will be included.~      Sites will be treated by ultrasonic debridement of the pocket, performed using a piezoceramic~     ultrasonic device. For the purpose, a Tip will be connected to the Handpiece Led (5~     minutes/pocket) . Then, it will be followed by the subgingival use of erythritol powder~     applied by the use of Handpiece connected to an airflow unit 2x5 seconds/pocket. At this time~     the subgingival delivery of metronidazole gel will be provided. After instrumentation,~     patients will rinse with chlorhexidine 0.20% 3 times/day for 2 weeks.~      At baseline, 1 month, 3 months and 6 months the following parameters will be evaluated:~     Probing Pocket depth (PPD), Bleeding on Probing (BoP), Clinical Attachment Level (CAL).~   "
117936|NCT02023840|"~     Aim of the present study is evaluate the use of erythritol powder with/without the adjunct of~     local metronidazole in the treatment of periodontal pockets.~      20 consecutive adult periodontal patients, requiring cause-related therapy as phase 1 of~     their treatment plan, and presenting ≥4 sites with probing pocket depth ≥4mm will be~     enrolled. For each patients four sites will be considered for the study, and two sites will~     be allocated in the test group and two sites will be allocated in the control group. In the~     test group, ultrasonic debridement of the pocket will be performed using a piezoceramic~     ultrasonic device with the a tip connected to the handpiece for 5 minutes/pocket. Then, it~     will be followed by the subgingival use of erythritol powder 2x5 seconds/pocket. At this time~     the subgingival delivery of metronidazole gel will be provided. In the control group, the~     same protocol will be used except for the use of a placebo instead of metronidazole. After~     instrumentation, patients will rinse with chlorhexidine 0.20% 3 times/day for 2 weeks.~      At baseline, 1 month, 3 months and 6 months the following parameters will be evaluated:~     Probing Pocket depth (PPD), Bleeding on Probing (BoP), Clinical Attachment Level (CAL).~   "
117937|NCT02023827|"~     Juvenile crime imposes enormous costs on victims, on society, and on juvenile offenders~     themselves. However, research assessing the efficacy of interventions for young offenders~     show, on average, only small effects on recidivism, substance abuse, and other behavioral~     outcomes. A major problem with existing interventions is that they tend to neglect individual~     differences in motivation and readiness to make positive changes. In earlier research, we~     used an empirically validated model of behavior change, the Transtheoretical Model (TTM, the~     stage model), and expert system technology to develop the Rise Above Your Situation program~     (RAYS), a prototype of a multimedia computerized tailored intervention designed as an adjunct~     to traditional juvenile justice programs. The intervention delivers assessments and~     individualized feedback matched to readiness to stay out of trouble with the law and quit~     alcohol and drugs. At the end each session the program also generates a helpgiver report that~     summarizes the youth's feedback and presents concrete, easy-to-implement strategies~     helpgivers can use to reinforce stage-matched concepts. In the current research, the goals~     are to complete development of the computerized tailored intervention; develop training and~     other support materials for helpgivers; and assess the efficacy of the intervention package~     in a randomized clinical trial involving 700 medium- to high-risk court-involved juveniles~     aged 13-17 recruited by 54 probation officers randomly assigned to treatment or standard~     care. Primary outcomes will be criminal recidivism and substance abuse abstinence at 6 and 12~     months follow-up.~   "
117938|NCT02023814|"~     Stem cell mobilization procedures after chemotherapy and G-CSf performed at our Institution~     between 2002 and 2013 were reviewed in order to define prognostic factors for optimal harvest~   "
118742|NCT02013310|"~     This is a Phase 2 randomized, multicenter, double-blind, placebo-controlled, parallel-group~     study to evaluate the efficacy of HT-0712 in improving memory and cognitive performance in~     subjects with Age-Associated Memory Impairment (AAMI)~   "
117942|NCT02023762|"~     Percutaneous mitral valve repair (PMVR) with the MitraClip® system has emerged as a~     therapeutic alternative to surgical valve repair in patients who are at high risk and~     unsuitable for surgery. The PMVR procedure is typically performed under general anaesthesia,~     but the MitraClip® is also feasible in deep sedation.~      The aim of this study is to investigate the safety of deep sedation in patients undergoing~     the PMVR procedure and to evaluate how deep sedation in comparison to general anaesthesia~     influences procedural time and in-hospital stay.~   "
117943|NCT02023749|"~     This study aimed to investigate the effects of nut consumption on metabolic parameters and~     biomarkers related to inflammation, oxidative stress, and endothelial function in Korean~     adults with metabolic syndrome.~   "
117944|NCT02023736|"~     This study is a comparison of client outcomes in two different types of psychotherapy~     treatment. In one condition clients will receive treatment-as-usual (TAU); the therapy that~     they would normally receive. In the other condition clients will receive treatment-as-usual~     but in addition their therapist will have access to empirical feedback on client progress.~     Clients in the feedback condition will fill out weekly online questionnaires, and their~     therapists will have access to a website that feeds back the results of these questionnaires.~     The purpose of the study is to understand the impact of providing such feedback to~     therapists. Participating therapists at 4 sites will offer all of their clients the~     opportunity to participate, and participating clients will be randomly assigned to either~     condition. This should result in a representative sample of client seeking treatment at these~     4 Chicago-area clinics.~   "
117945|NCT02023723|"~     This study is designed as a safety assessment to determine the cardiac and hemodynamic~     effects of overuse of energy drinks in healthy individuals through ECG, heart rate (HR) and~     blood pressure measurements. It will evaluate the use of a consumer available product that is~     classified as a dietary supplement by the FDA.~   "
117946|NCT02023710|"~     Mucosal melanoma is rare and associated with extremely poor prognosis.No effective treatment~     for advanced mucosal melanoma patients.Investigators conducted a randomized phase II study in~     patients with previously untreated metastatic mucosal melanoma to characterize the efficacy~     and safety of bevacizumab when combined with carboplatin plus paclitaxel.~   "
117947|NCT02023697|"~     This study will assess different doses and regimens of radium-223 dichloride on the incidence~     of symptomatic skeletal events. Eligible subjects must have castration resistant prostate~     cancer with 2 or more skeletal metastases documented within 8 weeks of randomization.~     Subjects will be randomized to one of 3 treatment arms in a 1:1:1 fashion: a standard regimen~     of radium-223 dichloride of 50 kBq/kg (55 kBq/kg after implementation of NIST update)~     injections every month for 6 months, a high dose regimen of 80 kBq/kg (88 kBq/kg after~     implementation of NIST update)injections every month for 6 months or an extended duration~     regimen of 50 kBq/kg (55 kBq/kg after implementation of NIST update) injections every month~     for 12 months. Following the treatment phase, subjects will be followed up every 12 weeks for~     a minimum of 2 years, at which point they will enter a long term follow-up period during~     which they are seen every 6 months for up to 7 years after the last dose of radium~     dichloride. Symptomatic skeletal event and safety endpoints will be assessed at each clinic~     visit. Pain and analgesic use data will be collected every 4 weeks through Week 48.~     Additionally, radiological assessments including MRI/CT of the abdomen and pelvis and chest~     CT, as well as technetium-99 bone scans will be performed at Weeks 8, 16, and 24 and continue~     every 12 weeks thereafter until disease progression is documented in either the bone or in~     soft tissue. Radiological imaging will be evaluated by blinded central review.~   "
117948|NCT02023684|"~     The aim of this study is to evaluate the effect of ropivacaine and lidocaine irrigation at~     the surgical bed on postoperative pain relief and breathing parameters in laparoscopic sleeve~     gastrectomy.~   "
117949|NCT02023671|"~     The study proposed by SSCVD Allogeneic Stem Cells of this Hospital provides for the~     collection of a series composed of patients with multiple myeloma undergoing allogeneic stem~     cell transplants at our center in the period 2000-2011.~      This collection is carried out with retrospective investigation , through the review of paper~     and electronic records and data cards already collected as part of clinical trials conducted~     by our own Division and approved by the Ethics Committee of Management.~      The purpose of data collection is particularly retrospective analysis of the incidence of~     extramedullary relapse , the response in flow cytometry immunophenotypic and clinical~     response of the disease , will also be taken into consideration for overall survival ( OS) ,~     event-free survival (EFS) , the cumulative incidence of treatment-related mortality and~     graft- versus-host disease ( GVHD ), acute and chronic.~      The data were processed in a completely anonymous and as provided by law. The results of the~     study will not result in any diagnostic or therapeutic intervention on patients still alive.~   "
117950|NCT02023658|"~     Despite significant increases in global health investment and the availability of low-cost,~     efficacious interventions designed to reduce mother to child HIV transmission in low and~     middle income countries with high HIV burden, the translation of these scientific advances~     into effective delivery strategies has been slow, uneven and incomplete. As a result,~     pediatric HIV infection remains largely uncontrolled. Enhancing the implementation of pMTCT~     interventions through contextually appropriate systems analysis and improvement approaches~     can potentially reduce drop-offs along the pMTCT cascade, leading to dramatic improvements in~     infant and maternal outcomes. The goal of this proposal is to develop a model for systematic~     assessment and improvement of pMTCT services in sub-Saharan Africa. In specific aim 1, we~     will identify health system factors and service delivery approaches associated with high and~     low performing pMTCT services in Côte d'Ivoire, Kenya and Mozambique. In specific aim 2 we~     will adapt evaluate the feasibility and impact of a systems analysis tool and associated~     performance enhancement approach for pMTCT services in Côte d'Ivoire, Kenya and Mozambique.~     This systems analysis tool and associated performance enhancement approach is currently being~     developed and piloted for pMTCT services in Mozambique. The results of this implementation~     research are expected to generate knowledge of global health significance, and by~     disseminating the study results and intervention tools through the broad PEPFAR network, can~     rapidly impact pMTCT service delivery enhancements across the highest need countries.~   "
118743|NCT02013297|"~     The purpose of this study is to evaluate the efficacy of hypofractionated stereotactic~     radiation treatments (SBRT) on children, teenagers and young adults malignant tumors.~   "
117952|NCT02023632|"~     Regular physical activity is associated with a diverse range of physical and mental health~     outcomes, with the effects being particularly pronounced among older adults. Despite these~     health benefits, involvement in physical activity has been found to decline over the course~     of adulthood with older adults in particular risk of inactivity. A growing body of evidence,~     however, suggests that group-based settings that are sensitive to both the age-composition~     and gender-composition of their constituent members may represent an opportune means of~     supporting the improved adoption and maintenance of older adults in physical activity~     programs. The overall purpose of this feasibility trial is to test the effectiveness of a~     group-based physical activity program for older adults that is sensitive to both~     age-congruent and gender-congruent contextual factors, in supporting their sustained~     involvement in physical activity.~   "
117953|NCT02023619|"~     The purpose of the study was to identify corneal epithelial- and stromal-thickness~     distribution patterns in keratoconic eyes using spectral-domain-optical coherence tomography~     (SD-OCT).~      Study Hypothesis: SD-OCT provides necessary details about the distribution of corneal~     epithelial and stromal thicknesses for identification of a pattern characteristic for early~     keratoconus.~   "
117954|NCT02023606|"~     An Open-Label, Single-Dose, Mass-Balance Study to Assess the Absorption, Metabolism, and~     Excretion of Radio Labeled SPN-810M in Healthy Adult Male Volunteers~   "
117955|NCT02023593|"~     This phase Ⅱ study was designed to evaluate the efficacy and safety of FOLFIRI as second-line~     treatment for metastatic esophageal carcinoma.~   "
117956|NCT02023580|"~     Although HIV testing and highly effective antiretroviral therapy (ART) have improved survival~     with HIV, the relatively low level of ART adherence presents a significant public health~     challenge in terms of the potential to transmit HIV. Preventing transmission in virally~     unsuppressed HIV+ MSM who have condomless anal sex (CAS) with serodiscordant partners can~     have a great public health impact. As new HIV infections in MSM have been attributed in part~     to increased access to sex partners online, it is critical to deliver behavioral~     interventions to HIV+ MSM online to reach many high-risk men at a relatively low cost.~      The investigators' theoretically-grounded HIV prevention videos about CAS, HIV disclosure,~     and testing in MSM were rigorously evaluated among MSM recruited online. Findings indicated~     significant reductions in CAS and significant increases in HIV status disclosure at 3-month~     follow-up, compared to baseline. In a subsequent online, randomized controlled trial (RCT)~     for MSM, investigators found significant reductions in CAS among MSM in the video arm at~     60-day follow-up, compared to baseline; HIV+ MSM in the video arm reduced UAI, including~     serodiscordant CAS (SDCAS) at 60-day follow-up, compared to baseline. Based on these~     findings, investigators worked with POZ.com (POZ), the largest website for HIV+ individuals,~     to test whether they could recruit ethnically diverse HIV+ MSM and were very successful. The~     investigators have identified a potentially highly effective and feasible risk reduction~     intervention approach for HIV+ MSM.~      With the commitment of POZ and a strong team of experts, the investigators propose to reshoot~     the videos to show the perspective of an HIV-positive man's experience with relationships and~     struggle ART adherence. The intervention videos will provide short doses for 10 online~     sessions (including boosters). We will target HIV+ MSM who are virally unsuppressed and~     monitor self-reported clinical indicators (i.e., viral load). Further, we will target online~     recruitment by race/ethnicity to enroll equal numbers of HIV+ White, Black and Hispanic MSM~     for balanced representation; improving retention with incentives and a proven online~     platform; including educational information about ART adherence; and cost and~     cost-effectiveness analyses for potentially averted HIV infections to determine~     health-related cost savings. Online, the investigators will recruit and follow a national~     sample of 1,500 high-risk, virally unsuppressed HIV+ MSM for 12 months.~   "
117957|NCT02023567|"~     Major depressive disorder (MDD) is one of the most common psychiatric disorders, with high~     recurrence rate, suicide rate and disability rate. It's reported that the global burden~     caused by MDD will be up to the second rank among all the disease burdens by 2020. China is~     also confronted with the daunting challenges against MDD. It's assessed that the monthly~     incidence of MDD is 6.1%, non-hospitalizing rate reaches up to 92% and the non-treatment rate~     is approximate 95%. However, to date, the pathogenesis of MDD is obscure and the current~     therapies don't work well. Therefore, it's urgent and critical to elucidate the pathogenesis~     of MDD, to develop early diagnostic criteria and effective intervention in MDD. Considering~     the diversity of weights on genetic factor and environmental factor in MDD, in this project,~     the investigators aim firstly to explore the effect of genetic-environmental interactionon~     the pathogeny of MDD for classifying MDD into genetic type, environmental type and~     others based on a case-control study. We next conduct the neurobiological, neurocognitive~     and psycho-behavioral assessments among MDD, schizophrenia and healthy groups to screen the~     salient endophenotypes for establishing the diagnostic models of MDD . The investigators~     further analyse the changes of these indicators after 8 weeks'medication to select the~     potential predictors for therapeutic evaluations and interventional options in MDD patients.~     Finally, the investigators continue a 2-year follow-up study to test and verify the~     predictors of prognosis in MDD patients.~   "
117958|NCT02023554|"~     Macrolides are potent inhibitors of cytochrome P450 isoenzyme 3A4（CYP3A4）and thus interfere~     with the pharmacokinetics of many other drugs that are metabolised by this enzyme like~     theophylline.The aim of this study is to determine whether azithromycin can effect~     theophylline metabolism in patients.~   "
117959|NCT02023541|"~     Assess progression-free survival and overall survival of proton beam therapy (PBT) for~     patients with resectable vs. unresectable esophageal cancer, and to assess patient-reported~     outcomes of PBT for esophageal cancer at 6 months following chemoradiation and~     physician-reported toxicity of PBT for esophageal cancer.~   "
117960|NCT02023528|"~     Based on the Medicare data, the 5-year survival of dialysis patients is only 39%. This is~     lower than that of stage IIIB breast cancer (54% 5-year survival). The annual mortality of~     dialysis patients is ~ 23% compared to <0.1% in the United States general population. Even~     kidney transplant recipients have a substantially higher mortality (~7%) compared to the~     general population. Consequently, the life-expectancy of dialysis and transplant populations~     is much lower than that of the general population. Cardiovascular events are the leading~     cause of death in dialysis patients and malnutrition is also a strong risk factor for death.~     The current proposal is to develop a prospective registry of incident dialysis patients at~     the University of Utah dialysis program to examine cardiovascular and nutritional factors in~     dialysis patients. This registry will include clinical and administrative data. In addition,~     blood samples will be stored for future analyses.~   "
117961|NCT02023515|"~     The purpose of this study is to learn the impact stress may have on weight management and~     emotional eating.~   "
118209|NCT02020265|"~     EEG protocols exist for reducing stress and improve PTSD symptoms (A/T EEG protocols,~     Peniston, 1993, Hammond, 2005) however; our innovative EEG-NF LMI approach intends to be more~     amygdala/stress specific and therefore more efficient. Three groups of soldiers, while in~     operational activity will go through 24 sessions of 3 different methods of EEG-NF; our newly~     developed NF via MLI, a standard procedure for NF via A/T and a placebo NF. Difference~     between the groups in regard to their emotion regulation capability will be tested by fMRI~     with regard to amygdala activation following EEG-NF LMI as well as two stress challenge~     tests.~   "
117962|NCT02023502|"~     Objective: The primary objective of the study is the comparison of protein concentrations~     between patients with stress urinary incontinence (SUI) and healthy controls.~      Aim: This pilot study aims to determine a possible altered protein profile in women suffering~     from SUI, compared to healthy women and therefore to discriminate a potential protein~     biomarker for SUI.~      Main outcome measure: mass spectrometric measuring of urinary proteomic secretome in diseased~     and healthy subjects (sequence coverage and number of identified proteins)~      Trial design: Prospective case- control study~      Setting: Department of Gynecology and Obstetrics of the Medical University of Vienna in co-~     operation with the Core Facilities Proteomics of the Medical University of Vienna~      Population: Twenty female patients with SUI and twenty healthy patients who attend the~     outpatient clinic of the Department of Obstetrics and Gynaecology, Medical University of~     Vienna (sample size calculation FDR 0.05, power of 80%, assumed proportion of true H0 0.95,~     assumed standardized effect size of 1)~      Methods: Examinations to be carried out: patient history, provocative stress test, ICIQ short~     form questionnaire, residual urine volume (ultrasound) and urine analysis (dipstick testing).~     A urine sample is obtained from the patient after spontaneous micturition, to which protease~     inhibitor will be added immediately. Two serum blood vials (each 9ml) are taken from a~     peripheral vein of the patient for routine laboratory and further research.~      Proteomics analysis will be performed using chromatographic separation (LC) with mass~     spectrometric detection (MS).~   "
117963|NCT02023489|"~     Background:~      Type 2 diabetes mellitus is a main risk factor for cardiovascular disease and heart failure,~     in part due to diabetic cardiomyopathy. However, the association between intracellular lipid~     accumulation and (myocardial) functional impairment is likely more complex than originally~     imagined. Recent studies suggest that not fat per se, but the content of saturated or~     unsaturated fatty acids might predict the development of cardiac steatosis and myocardial~     dysfunction.~      In addition skeletal muscle and hepatic glycogen metabolism is impaired in patients with~     diabetes mellitus. Data from animal experiments suggest a relevant role of myocardial~     glycogen stores in ischemic preconditioning. Due to methodological limitations so far data on~     myocardial glycogen stores and myocardial lipid composition in humans are missing.~      Hypothesis:~      In addition to total ectopic lipid deposition in the myocardium, myocardial lipid~     composition, i.e. the relative abundance of saturated and unsaturated fatty acids, and~     impaired myocardial glycogen metabolism may play an important role in the development cardiac~     lipotoxicity leading to diabetic cardiomyopathy.~      Pancreatic endocrine function and myocardial morphology and function is altered in patients~     with heterozygote inactivating mutations of the CaSR-gene / FHH.~      Aims:~        -  Metabolic virtual biopsy of the myocardium for identification of specific patterns of~          intracellular lipid composition and myocardial glycogen metabolism as possible critical~          determinants of metabolic cardiomyopathy~        -  Characterization of the metabolic interplay between the myocardium, skeletal muscle,~          liver and adipose tissues in different stages of development of type 2 diabetes compared~          to patients with calcium sensing receptor mutation~      Methods:~        -  1H/13C and 31P magnetic resonance spectroscopy and imaging for measurements of~          myocardial, skeletal and liver lipid and glycogen content, abdominal adipose tissue~          distribution and composition, ATP synthesis and myocardial functional parameters~        -  Mixed meal tolerance tests to trace the postprandial partitioning of substrates between~          insulin sensitive tissues (myocardium, skeletal muscle, liver, adipose tissue).~        -  Hyperinsulinemic-hyperglycemic glucose clamp (HHC) with enrichment of the infused~          glucose with the stable isotope [1-13C]glucose to trace the incorporation of circulating~          glucose into myocardial glycogen~      in healthy insulin sensitive volunteers, prediabetic insulin resistant volunteers with~     impaired glucose tolerance, healthy subjects, patients suffering from type 2 diabetes~     mellitus, patients suffering from type 1 diabetes and patients with heterozygote mutation in~     calcium sensing receptor.~   "
117964|NCT02023476|"~     Nerve injury is a serious potential complication associated with the clinical use of~     exsanguinating tourniquets in surgery. Recently, a novel narrow tourniquet has been proposed,~     with the claim that it may cause less compression of the nerves. We performed an in vivo~     comparison of a standard wide tourniquet with the new, narrow tourniquet. Our study~     specifically looked at neurologic markers in the upper extremity.~   "
117965|NCT02023463|"~     This phase I trial studies the side effects and best way to give enzalutamide, radiation~     therapy, and hormone therapy in treating patients with intermediate or high-risk prostate~     cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as~     enzalutamide, may lessen the amount of androgens made by the body. Radiation therapy uses~     high energy x rays to kill tumor cells. Giving enzalutamide, radiation therapy, and hormone~     therapy may be an effective treatment for prostate cancer.~   "
117966|NCT02023450|"~     Study Rationale:There is recent evidence that HIV protease inhibitors (HIV-PI) can improve~     pulmonary hemodynamics in experimental models of pulmonary arterial hypertension (PAH). There~     is also experimental evidence that both TLR4 and high mobility group box 1 (HMGB1)~     participate in the pathogenesis of experimental pulmonary hypertension. A recent high~     throughput screen for inhibitors of HMGB1 induced macrophage activation yielded HIV-protease~     inhibitors (PIs) as potent inhibitors of HMGB1 induced cytokine production. Based on the~     experimental evidence we propose a trial to determine whether HIV-PIs will alter the~     pathobiology of PAH.~      Study Objectives:The main objective of this study is to determine whether saquinavir and~     ritonavir (SQV+RIT) which have a well-characterized safety profile in humans will reduce bio~     markers of inflammation and pulmonary artery pressures in patients with PAH.~      Study Hypothesis:We hypothesize that the HIV-PI, SQV+RIT, will reduce circulating parameters~     of inflammation including HMGB1, IL1-beta, IL-6, IL-8, IL-10, TNF-alpha and CRP. Our end~     points will be changes in these parameters from baseline over the duration of the study.We~     hypothesize that treatment with SQV+RIT will reduce pulmonary artery(PA) pressure of patients~     with PAH as measured by echocardiography.~      Study Design:This is a single center open label phase 0 study to evaluate the effect of SQV~     +RIT in patients with IPAH. Subjects with IPAH(N=20) will be enrolled into a study, which~     will be divided into 3 cohorts and entail the administration of HIV protease inhibitors in~     three doses. The first cohort (n=3) will receive a starting dose of SQV 0.3 mg/kg twice daily~     in combination with RIT 0.03 mg/kg twice daily. If the first dose is well-tolerated, the~     second cohort (n= 3 ) with IPAH will be given doses of SQV 3 mg/kg and RIT 0.3 mg/kg twice~     daily. If the second dose is well-tolerated, the last cohort (n= 14 ) with IPAH will be given~     doses of SQV 15 mg/kg and RIT 1.5 mg/kg twice daily.~   "
117967|NCT02023437|"~     This clinical study is a prospective, post-market-clinical-follow-up study to investigate the~     long-term (3 months) safety of femtosecond laser assisted cataract surgery as a study~     follow-up extension to the Study #1304 titled as A Multi-centre, Multi-surgeon, Randomized,~     Controlled, Prospective, Post-Market-Clinical-Follow-Up Study to Investigate the Impact of~     Cataract Grade on the Efficacy and Safety of Femtosecond-laser Assisted Lens Fragmentation~     Procedure.~   "
117979|NCT02023281|"~     The purpose of this study is to examine the effects of exercise on the symptoms of depression~     using serum levels of serotonin, catecholamine's, Alpha EEG asymmetry, and self-report of~     symptoms as markers.~      In an attempt to further understand the mechanisms of improved mood through exercise; this~     study will examine the known factors that contribute to depressed mood in a single study~     using serotonin and catecholamine levels via blood serum and EEG slow wave asymmetry. Such~     information can be useful in understanding the overall neurological components of depression~     and the effects of exercise on the brain in depressed individuals that would make the~     prescription of exercise a viable treatment option.~   "
117980|NCT02023268|"~     Comparison of the efficacy and safety of T2762 and Vismed® in the treatment of moderate to~     severe Dry Eye Syndrome~   "
117981|NCT02023255|"~     The purpose of the study is to evaluate the safety and tolerability of multiple dose~     administration of JNJ-39393406 in young healthy participants, and subsequently in healthy~     elderly participants.~   "
117982|NCT02023242|"~     This clinical trial compares two implantable devices intended to lower the pressure inside~     the eye of glaucoma patients.~   "
117968|NCT02023424|"~     Primary Objective: To test the hypothesis that 6 months treatment with glatiramer acetate~     (GA) decreases epileptiform activity in young girls with Rett syndrome.~      Primary Safety Objective:To evaluate the safety and tolerability of 6 months treatment with~     GA in these patients.~      Secondary Objectives:~        1. To test the hypothesis that 6 months treatment with glatiramer acetate (GA) improves~          respiratory dysfunction.~        2. To evaluate the effect of GA treatment on general behaviour communication, hand~          stereotyping, feeding, sleep and other autonomic symptoms: gastrointestinal and cardiac.~        3. To assess the effect of GA treatment on bodily development.~      Primary Endpoint:Improvement of epileptiform activity as recorded in a 24-hours EEG.~      Primary Safety Endpoint:Frequency and severity of treatment-related AEs (including safety lab~     parameters).~      Secondary Endpoints:~        1. Improvement in the scoring of breath holds and hyperventilation, as measured with~          non-invasive respiratory inductance plethysmography (NoxT3 device) and parents' diaries.~        2. Changes in general behaviour, communication, feeding and motor skills as assessed by the~          investigator (based on Kerr and Naidu validated severity scores) and recorded in~          parents' diary.~        3. Decrease in seizure frequency as reported in parents' diary.~        4. Improvement in sleep schedule as recorded in a sleep diary.~        5. Change in height and weight. Population:Ten girls, 6 to 15 years old, diagnosed with~          Rett syndrome (RTT) Study Design:This is a single - center, exploratory, open-label,~          study in 10 girls diagnosed with RTT. The study will consist of four parts: Screening~          and baseline assessments, initial and final dose-setting period, treatment period and~          end-of study follow-up.~      Investigational Product:Glatiramer Acetate (Copaxone® , Teva Pharmaceutical Industries Ltd.)~     Sample Size Consideration: The planned sample size of 10 patients was considered adequate by~     the investigator for this phase I exploratory proof-of-concept study. The study is not~     expected to show statistical significance or statistical power, only a trend for the study~     endpoints. Each patient will serve as her own control.~      Duration of Study: Approximately 8 months per patient (including up to 2 weeks pre-treatment~     assessment, 6 months initial dose and treatment periods and end-of study visit).~      Overall study duration: the study is expected to be completed within 12 months (dependent on~     rate of recruitment).~   "
117969|NCT02023411|"~     Diabetic foot represents a major medical , social and economic problem worldwide.~      Charcot's neuroarthropathy, being a common cause of diabetic foot, has been an intriguing~     topic of research for endocrinologists, podiatrists and surgeons. After its first description~     by JEAN-MARTIN CHARCOT in 1868, many theories have been put forward regarding its~     pathophysiology , but not much research has been done for its prevention and treatment ,~     specially the inactive stage.~      The course of Charcot 's neuroarthropathy is triphasic , with the diagnosis being usually~     missed in the active stage, henceforth the patients often come to us with a deformed foot. As~     a consequence , the osteoclastic activity in active stage renders the foot bones~     demineralized and weak, thus being susceptible to fracture and fragmentation.~      Teriparatide is recombinant human (1-34) parathyroid molecule that has been approved for~     post-menopausal osteoporosis and in men with primary or secondary osteoporosis. It acts by~     preferentially stimulating osteoblast over osteoclast activity resulting in new bone~     formation and an increase in the rate of bone remodeling which manifest as an increase in~     skeletal mass and bone mineral density .~      Keeping the pathophysiology of Charcot's foot in mind, teriparatide may be used as potential~     treatment for inactive Charcot's neuroarthropathy but there are no studies or randomized~     trials in this setting, till date. We hypothesize that teriparatide may increase the~     remodeling of foot bones in Charcot's neuroarthropathy, improve bone mineral density,~     subsequently leading to a reduction in the risk of fractures and progression of deformities.~     This study plans to compare the effects of teriparatide in diabetes patients with inactive~     Charcot's foot in a placebo controlled design.~   "
117970|NCT02023398|"~     Prospective, two-arm, randomized study of the effectiveness of the BTL-9000 HFT in achieving~     3 cm or greater average waist circumferential reduction in HFT group of subjects relative to~     the base line and 1 cm or greater reduction relative to the average waist circumferential~     reduction of the Placebo group.~   "
117971|NCT02023385|"~     Prospective, two-arm, randomized study of the effectiveness of the BTL-9000 LLLT in achieving~     3 cm or greater average waist circumferential reduction in LLLT group of subjects relative to~     the base line and 1 cm or greater reduction relative to the average waist circumferential~     reduction of the Placebo group.~   "
117972|NCT02023372|"~     The purpose of this study is to determine whether NuCel is effective in promoting spinal~     fusion in degenerative disease of the lumbar spine.~   "
117973|NCT02023359|"~     An observational study in patients with advanced ER+, HER2 negative breast cancer, who are~     treated with everolimus and exemestane in combination. The objective of the study is to~     assess the safety pattern of everolimus in a real world setting.~   "
117974|NCT02023346|"~     The purpose of this study is to learn more about the understanding patients with brain tumors~     have of their disease and their communication with their physician. Ultimately, we hope to~     use these findings to improve communication between patients and their doctors.~   "
117975|NCT02023333|"~     The purpose of this study is to evaluate the good and bad effects when regorafenib is used~     instead of standard combination chemotherapy. It is not known if taking regorafenib versus~     standard chemotherapy will have better, worse or the same results.~   "
117976|NCT02023320|"~     The purpose of the present study is to evaluate the effect of blueberry dry powder on~     glycemic status (fasting plasma glucose, 2h glucose concentration after the oral glucose~     tolerance test (OGTT), or HbA1c) in subjects with prediabetes.~   "
117977|NCT02023307|"~     This study will evaluate and measure the Vloc suture's ability to elevate the mid-face when~     using a short flap, short incision technique in during a traditional face-lift. The objective~     of this study is to assess the suture's potential in elevating the mid-face when a~     traditional Lifestyle facelift is performed. We hypothesize that the Vloc suture will elevate~     the mid-face more effectively when using a short flap, short incision technique on a~     traditional facelift.~   "
117978|NCT02023294|"~     Bariatric surgery has been established as the best treatment for morbid obesity, compared~     with diet or medical treatment. Laparoscopic approach have improved the results of this~     surgery in terms of postoperative pain, reduction in the number of complications and hospital~     stay, as well as better cosmetic results. Conventional laparoscopic technique requires five~     to seven abdominal incisions to facilitate placement of the multiple trocars. New Single~     Incision Laparoscopic Surgery (SILS)has been developed as a new technique where only one~     incision is needed for the introduction of all trocars. Altough this technique can be~     performed with conventional laparoscopic instruments, new devides have been developed for~     facilitate this operations by SILS. The investigators think that reducing the number of~     incision would decrease the postoperative pain and improve cosmetic results in our patients,~     being a safe and technically feasible intervention supported by these special devices.~   "
117983|NCT02023229|"~     Malnutrition is a frequent complication in patients with liver cirrhosis. Most patients have~     decreased dietary intake due to ascites, hepatic encephalopathy and pro-inflammatory~     cytokines.~      We hypothesized that branched chain aminoacids can improve nutritional status and delay~     episodes of hepatic encephalopathy~   "
117984|NCT02023216|"~     Gastro-esophageal reflux (GER) is a common condition among preterm infants, due to several~     physiological promoting factors. To limit the potentially harmful widespread of~     pharmacological treatment, a step-wise approach, which firstly applies conservative~     strategies, is currently considered the best choice to manage GER in the preterm population.~     Among the most common conservative strategies, postural measures seem to represent an~     effective measure to reduce GER features in symptomatic preterm babies, whereas feed~     thickening is almost ineffective. Non-nutritive sucking (NNS) is a care strategy largely~     applied in the Neonatal Intensive Care Unit (NICU) settings. The act of swallowing is both~     reported to trigger the onset of transient lower esophageal sphincter relaxations (TLESRs),~     thereby eliciting to GER episodes, and to promote the esophageal clearance of refluxate.~     Hence, a possible effect of NNS on GER features might be hypothesized.~      This observational, prospective and explorative study primarily aims to explore the effect of~     NNS, applied by means of a pacifier, on acid and non-acid GER features, evaluated in~     symptomatic preterm infants (gestational age ≤32 weeks) undergoing a diagnostic combined pH~     and multiple intraluminal impedance (pH-MII). The secondary aim of this study is to evaluate,~     in the subgroup of patients with recurrent GER-related apneas, the effect of NNS on~     cardiorespiratory events, defined as bradycardias and total, central, obstructive, mixed~     apneas and detected by a simultaneous polysomnographic monitoring.~   "
117985|NCT02023203|"~     Inguinal hernia repair is one of the most commonly performed surgeries around the world. It~     accounts for approximately 75% of all abdominal wall hernias and presents a lifetime risk of~     27% in males and 3% in females. Since the modern concept of surgical hernia repair described~     by Bassini in 1887, with the technique that bears his name, several techniques have been~     developed in the last century in order to improve surgical outcomes after inguinal hernia~     repair.~      Different open repairs, such as anterior (Shouldice, McVay) or posterior (Stoppa) approach~     were described and developed, until Lichtenstein described the tension-free hernioplasty~     concept supported by the use of a prosthetic mesh to repair the hernia defect. Notable~     Improvements were observed with this technique in terms of recurrence, pain, and discomfort~     in comparison with previous tension repairs. Considerable advantages over open repair have~     been obtained with the introduction of minimally invasive surgery to inguinal hernia repair,~     in terms of patient comfort and recurrence rates.~      Regarding prosthetic material, meshes have evolved since the first Dacron mesh used by~     Lichtenstein. First generation meshes were manufactured using more material and for this~     reason they have been described as heavyweight meshes. New generation meshes have been~     designed with less material in order to diminish the inflammatory response and foreign body~     reaction, providing less chronic pain with similar recurrence rates than heavyweight meshes.~     The density (or weight) of the mesh, measured in g/m2, is inversely proportional to the size~     of the pore and lately it has been reported that one of the main aspects related to~     prosthetic materials is pore size. Large pore meshes use less material, consequently they~     have been associated with a better tissue ingrowth. The large pore of lightweight meshes is~     conditioned by the less amount of material used.~      All previous studies compare both light and heavyweight polypropylene meshes But in order to~     get a proper comparison of the behavior of meshes in the inguinal region it is important to~     include the material and the pore size. The aim of our study is to compare patient-reported~     outcomes with the use of either a Polytetrafluoroethylene (PTFE) large pore mesh (LP-PTFE) vs~     a small pore polypropylene mesh (SP-PPL).~   "
117986|NCT02023190|"~     Liver transplant is the goal treatment for every patient with end-stage chronic liver~     disease.~      Quality of life improves after transplant because the main complications of end-stage liver~     disease disappear, but due to immunosuppression other alterations appear such as metabolic~     alterations, weight gain, among others.~      Body composition and nutritional status can be affected do to post-transplant pharmacologic~     therapy.~   "
117987|NCT02023177|"~     A few PhA cut-off points have been proposed to define malnutrition in cirrhosis, and they~     have proven to be useful in prognosticating severity of the disease and mortality. However,~     PhA needs specific validation in different ethnic groups. The aim of this study was to~     evaluate the PhA cut-off value that would best define malnutrition and predict mortality in~     patients with liver cirrhosis.~   "
117988|NCT02023164|"~     This is a multicenter, parallel group, randomized, double-blind pilot Phase III clinical~     study of JDP-205 injection, versus diphenhydramine injection, 50 mg/mL (Benadryl or generic~     equivalent), in approximately 36 patients with acute urticaria requiring treatment in~     Hospital Emergency Departments, Urgent Care Centers and Allergy Clinics.~   "
117989|NCT02023151|"~     This research is being done to test whether differences in blood cells at baseline (start of~     the study) can be used to predict how well omalizumab will work in a patient. Omalizumab~     (Xolair) is a drug approved by the U.S. Food and Drug Administration (FDA) to treat asthma.~     Studies show that omalizumab improves the symptoms of asthma but some people experience~     better improvement than others.~   "
117990|NCT02023138|"~     There is a lack of evidence about the best method to involve the patient and population (IPP)~     into clinical practice guidelines (CPG) development. The goal of this pilot study is to~     document the acceptability, feasibility and effectiveness of two methods for the implication~     of patients with a traumatic brain injury (TBI) in CPG development. Method: A single blind,~     randomized crossover trial will be performed with patients having a TBI. Participants: A~     convenience sample of 20 patients a) with a moderate-to-severe TBI (Glascow Coma Scale <13),~     b) living with a TBI for two to four years, c) French-speaking, d) able to use a computer and~     e) able to participate in a two-hour group meeting will be recruited among the members of the~     Associations TCC Des Deux Rives. Procedures: The patients will first receive a in-person~     training on guidelines and IPP. They will be randomized into Group 1 or Group 2 by a~     researcher blinded to experimentation. They will experiment either group discussion (control~     intervention) or a Wiki (experimental intervention). Phase 1: A week after the training,~     Group 1 participants will be invited to a discussion group animated by an experimented~     moderator, where they will be asked to discuss a CPG recommendation chosen by the research~     team in an existing CPG. The participants will be asked : 1) about their opinion of the~     recommendation; 2) if they have a preference in regard to the recommendation ; 3) if they~     have some modification, correction or addition to bring to this recommendation. In the mean~     time, Group 2 participants will receive an email presenting a link to a Wiki. They will be~     invited to answer the same three questions as Group 1, but using a Wiki platform. The~     patients will have a week to interact and answer the questions; recalls could be sent by~     email if required. At the end of Phase 1, participants of both groups will fill a~     questionnaire documenting the acceptability of the method experimented. Phase 2: As per the~     crossover design, the Group 1 participants will then be assigned to the Wiki intervention and~     the Group 2 participants will be assigned to the discussion group intervention. The procedure~     will be repeated with a second recommendation. At the end of Phase 2, the patients will be~     asked to answer a short survey to validate their preferences about the two methods. Tools:~     The acceptability of the methods will be evaluated with a questionnaire adapted from Sidani~     and al. and validated with three TBI individuals. The feasibility of the intervention will be~     evaluated using a) the number of participants who reached the group or the Wiki, b) the~     number of participants who completed the intervention c) the number of support interventions~     required in the group and in the Wiki. The effectiveness of the two methods will be evaluated~     by submitting the adapted recommendations to a panel of expert clinicians evaluators blinded~     to the methodologies of recommendations adaptation. They will be invited to rate the clarity,~     accuracy, appropriateness and usefulness of the recommendations. Analysis: Feasibility~     indicators will be reported using descriptive statistics. Within-subject analysis using~     non-parametric statistics will be performed to assess the acceptability of the two methods.~     AC1 coefficient of raters' agreement will be calculated on the expert evaluation scores, and~     the effectiveness of the methods will be compared using appropriate non parametric statistics~     to. Impact: This pilot trial will be the first one to evaluate methodologies for involving~     disabled individuals into CPG development.~   "
117991|NCT02023125|"~     This two-group study will investigate the effect of food (Group 1) and esomeprazole (Group 2)~     on the single oral dose pharmacokinetics of alectinib in healthy volunteers.~      Participants in Group 1 will be randomly assigned to a two period treatment sequence (AB or~     BA) in which they will receive a single, oral dose of alectinib per period separated by at~     least 10 days. Each participant will receive single, oral doses alectinib given under fasted~     conditions (Treatment A) or following the ingestion of a high fat, high calorie meal~     (Treatment B) as determined by their assigned sequence.~      Participants in Group 2 will be given a single, oral dose of alectinib following a standard~     meal. After a washout period of at least 10 days, they will receive an oral dose of~     esomeprazole (40 mg) once daily for 6 days. On the 6th day of esomeprazole administration, a~     single, oral dose alectinib will be given after ingestion of a standard meal.~      In all groups, pharmacokinetics will be assessed in the 4 days following alectinib~     administration.~   "
117992|NCT02023112|"~     This is a Phase 3, randomized, open-label, multicenter study, enrolling non-cirrhotic and~     cirrhotic subjects. The purpose of this study is to evaluate the efficacy and safety of~     ABT-450/r/ABT-267 co-administered with weight-based RBV for 12 or 16 weeks in adult chronic~     HCV genotype 2-infected treatment-naïve and interferon (IFN) treatment-experienced subjects~     with and without compensated cirrhosis.~   "
117993|NCT02023099|"~     This is a phase 3, double-blinded, multicenter study. The study will consist of 2 substudies:~     Substudy 1 (SS1) will be double-blinded and enroll non-cirrhotic subjects and Substudy 2~     (SS2) will be open label and enroll subjects with compensated cirrhosis.~   "
118048|NCT02022384|"~     In this explorative study immunological changes during tumor therapy will be analyzed in~     patients with malignant glioma. Immunophenotyping before and during therapy is used as~     analysis method. Thereby immune cells are quantitatively and qualitatively detected from~     patient's blood at continuous time points. Additionally relevant mediators like cytokines,~     danger signals and chemokines are analyzed by other methods. Obtained results may give~     information about the effects of therapy on immunological processes and immune cells and may~     help to find immunological based predictive or prognostic tumor markers and to define time~     points for including additional immune therapy in the future.~   "
117994|NCT02023086|"~     This study aims to evaluate blood oxygenation at the optic nerve head in relation with visual~     field losses observed in many Fabry patients. Data collected will allow to evaluate if there~     is a link between these two entities.~      Study will last up to 2 years during which a limited number of Fabry patients will be~     compared to a control group to confirm any relationship between blood flow and field losses,~     and to see if these results vary over time.~      HYPOTHESIS~      1. Fabry patients will present significant differences in visual fields compared to control 2~     There will be variability of the visual field defects on the long term but not on the short~     term 3 Blood oxygenation will be higher for Fabry patients 4 Blood volume at the optic nerve~     head will be the same for both groups.~   "
117995|NCT02023073|"~     The use of lasers in medicine in general, and diagnosis and treatment in ophthalmology in~     particular, increased significantly. Making retinal surgery using lasers have become~     increasingly common. The goal: to diagnose eye diseases safely~   "
117996|NCT02023060|"~     The objective is to observe trends in patient characteristics and outcomes after aortic or~     mitral transcatheter heart valve replacement over time.~   "
117997|NCT02023047|"~     This is an open label study. The study will consist of 2 treatment group: coated Nifedipine~     suppository containing 12 mg of Nifedipine applied twice daily (group 1) and coated~     Nifedipine suppository containing 12 mg of Nifedipine applied once daily (group 2).~     Approximately 30 subjects will participate into this 8-week study. The primary objective is~     to examine the dose effect of coated Nifedipine suppository on Anal fissure pain and healing.~   "
117998|NCT02023034|"~     Introduction: Although the motor changes are well determined in Parkinson's disease (PD), few~     studies describe the effects the virtual exercises on the clinical and functional outcomes in~     this disease.~      Objectives: To analyze the effectiveness of virtual exercises on functional exercise~     capacity, fatigue and quality of life in patients with PD.~      Methods: 20 subjects, 60 years old will be included, who will be randomized into 2 groups:~     group of virtual exercises associated with conventional exercises (n = 10) and control group~     with conventional exercise group (n = 10).~      The following variables are evaluated: functional exercise through walking test in 6 minutes,~     fatigue by the Fatigue Severity Scale and Quality of Life through Quality of Life~     Questionnaire-PDQ-39.~   "
117999|NCT02023021|"~     Pancreatic cancer has an extremely poor prognosis with a 5-year survival rate of less than~     5%. About 25% of patients have the opportunity for radically surgical resection when~     diagnosis. However, the recurrence rate is up to 85% within 2 years. Data from clinical~     trials indicated that gemcitabine-based adjuvant chemotherapy reduced recurrence and enhanced~     overall survival for patients who have undergone surgery to remove their tumor.~     Nab-paclitaxel could enhance the intratumoral concentration of gemcitabine; recent studies~     showed that nab-paclitaxel plus gemcitabine significantly improved progression-free survival~     and overall survival of metastatic pancreatic cancer patients. The present study is intended~     to investigate the activity and safety of the combination of gemcitabine and nab-paclitaxel~     as adjuvant chemotherapy in treating patients with pancreatic cancer after curative~     resection.~   "
118000|NCT02023008|"~     This pilot clinical trial studies interactive gentle yoga in improving quality of life in~     patients with stage I-III breast cancer undergoing radiation therapy. Interactive gentle yoga~     may improve the quality of life in patients with breast cancer undergoing radiation therapy.~   "
118001|NCT02022995|"~     Protein arginine methylation is an important process, which regulates diverse cellular~     functions including cell proliferation, RNA stability, DNA repair and gene transcription.~     Based on literature search, protein arginine methyltransferase (PRMT) indeed plays important~     roles in colon cancer pathophysiology. The PRMT expression level is involved in colon cancer~     patient's survival and has been suggested to be a prognostic marker in colon cancer patients.~     Recently, our group found a novel methylation on epidermal growth factor receptor (EGFR),~     which affected EGFR downstream signaling. investigators further observed the methylation~     event on EGFR not only regulated tumor growth in mouse xenograft model but also influenced~     cetuximab response in colon cancer cell lines. To further study the clinical correlation~     between EGFR methylation and cetuximab response, we propose to detect EGFR methylation level~     in paraffin embedded tissue samples from colorectal cancer patients with or without cetuximab~     treatment by IHC staining and analyze its correlation with cetuximab response. This study~     will provide an insight to the strategy of colorectal cancer therapy.~   "
118002|NCT02022982|"~     This research study is evaluating the experimental drug palbociclib in combination with~     another experimental drug PD-0325901 as a possible treatment for cancers with KRAS mutations,~     particularly for those which started in the lung.~   "
118003|NCT02022969|"~     Even though experimental lung injury in animal experiments is the best analogy for the~     changes in the patients, it has to be considered that kinetics may vary between species. An~     important question to answer is how common PaO2-oscillations occur in patients and how~     injurious they might be. A limitation to the detection of PaO2-oscillations is a sensing~     device that detects the oscillations at very high temporal resolution. In previous studies a~     fiberoptic probe was used, which was measuring PaO2 based on oxygen-sensitive fluorescence~     quenching with a time resolution up to 10 Hz (8, 13, 14). This method is not feasible in~     patients. Previous studies have shown that PaO2-oscillations are translated into the~     peripheral hemoglobin oxygen saturation (SpO2). Given a technology that has a time resolution~     that is high enough (i.e. >1 Hz), measurement of SpO2-oscillations would be a valid approach~     to detecting and quantifying cyclical recruitment and derecruitment in a non-invasive fashion~     in patients on the ICU. The Masimo Rad-8 pulse-oxymeter provides such a method. In the~     current study it is planned to deteted SpO2-oscillations in the post-operative patients on~     the ICU.~   "
118004|NCT02022956|"~     The purpose of this study is to evaluate the PK properties, tolerability, and safety of~     lorcaserin HCL (BELVIQ) in obese adolescent subjects between the ages of 12 to 17 years old~   "
118109|NCT02021578|"~     The primary aim is to prevent depression in youth and parents in a single, integrated family~     intervention.~      Hypothesis 1a: Children in the Family Depression Prevention (FDP) program will have~     significantly fewer onsets of depressive episodes and lower levels of anxious/depressive~     symptoms as compared to children in the Written Information (WI) condition.~      Hypothesis 1b: In parents, the amount of time in a depressive episode will be significantly~     lower for those in the FDP program as compared to those in the WI condition.~   "
118005|NCT02022943|"~     The Alzheimer's Prevention Registry (www.endALZnow.org) will collect contact and demographic~     information on individuals. The objective is to provide information the latest news and~     advances in Alzheimer's prevention research, and to inform enrollees about research studies~     in their community. Enrolled individuals will receive regular email communications. As~     research studies become available, individuals will be notified via email with information as~     to how proceed should they be interested. Registry enrollees are under no obligation to~     participate in a research study. Study opportunities may include surveys, healthy lifestyle~     interventions (e.g., diet, exercise), memory & thinking tests, brain scans, and~     investigational drug trials. To join the Registry, please visit www.endALZnow.org~   "
118006|NCT02022930|"~     The purpose of this study is to evaluate the safety and efficacy of Hydros-TA Joint Therapy~     for relief of pain due to OA of the knee. Hydros-TA is designed to provide fast acting and~     long lasting pain relief for up to six months with a single IA injection.~   "
118007|NCT02022917|"~     This study is to determine the feasibility of postoperative platinum-based chemotherapy plus~     adjuvant and maintenance bevacizumab after neoadjuvant chemotherapy followed by interval~     surgery in patients with extensive stage IIIC or IV ovarian, tubal, and peritoneal cancer.~   "
118008|NCT02022904|"~     This is a minimal risk correlative clinical blood-drawing protocol. The objective of this~     lead in pilot component is to determine whether Circulating Tumor Cells (CTC's) can be~     captured using the novel mesenchymal-marker based Near Infrared-Emissive Polymersomes~     (NIR-EPs), the PSMA-based NIR-EP, and the epithelial EpCAM-based NIR-EP. If successful, the~     capture method will be evaluated further in the larger comparative study.~   "
118009|NCT02022891|"~     Sickle cell disease (SCD), a genetically transmitted blood disease, necessitates life-long~     care. In children, the disease may cause intense pain and other severe complications. Studies~     show that sources of stress, as well as complex psychological and intercultural issues~     associated with SCD, often aggravate symptoms. At Louis Mourier hospital, the treatment model~     used is systematic psychological and medical care. Our hypothesis is that this care is~     beneficial for both the children and their families as seen in improved quality of life and~     positive impact on medical symptoms.~   "
118010|NCT02022878|"~     Chronic total occlusions (CTO) are encountered in almost one-fourth of patients undergoing~     coronary angiography. The presence of an untreated CTO has been related to adverse clinical~     prognosis, both in stable angina and acute myocardial infarction, and is often associated~     with persistent symptomatic angina. Depending on their symptomatic and functional status as~     well as anatomical complexity, CTO can be treated by optimal medical therapy only or therapy~     combined with coronary revascularization.~      The potential benefits of percutaneous coronary intervention (PCI) in CTO include symptom~     relief, improved left ventricular function, and potentially a survival advantage associated~     with success when compared with failed revascularization. Of note, marked advances in~     endovascular techniques and device technology have resulted in substantial improvements of~     procedural success rates of PCI in CTO.~      In spite of these advances, the vast majority of patients with CTO are still being managed~     medically or referred for coronary bypass surgery rather than PCI. The most common reason for~     deferring PCI in patients with CTO appears to be the uncertainty of predicting the procedural~     outcome of percutaneous revascularization. Further barriers to attempting CTO by PCI include~     the difficulty of gauging the time required for the procedure and the use of resources.~      The CT-RECTOR (Computed Tomography REgistry of Chronic Total Occlusion Revascularization)~     study was designed to evaluate the application of coronary computed tomography angiography~     (CTA) for the prediction of procedural outcome of PCI in CTO in an international patient~     population. The main purpose of this multicenter registry is to develop a noninvasive~     CTA-based prediction tool (CT-RECTOR Score) for grading CTO suitability for PCI.~   "
118011|NCT02022865|"~     The main causes of adverse pregnancy outcome(s) are reported to be maternal infection and~     placental, foetal, or uterine pathosis. Maternal infection and placental pathosis appear to~     be the most important causal factors, possibly causing pre-term labour, premature pre-term~     membrane rupture, or result in medically induced pregnancy interruption. There are reports of~     a link between poor maternal periodontal health and composite adverse pregnancy outcome of~     pre-term low birth weight (PLBW). however, the reason for such correlation is still not~     clear.~      In the current study the investigators will try to follow a possible path between periodontal~     infection and uterus physiology, by signaling out inflammatory markers that may leak from the~     gingival fluid into the serum and from there to the amniotic fluid.~      the investigators will collect GCF, serum and amniotic fluid from patients undergoing~     elective amniocentesis and analyse inflammatory markers in the collected samples.~   "
118012|NCT02022852|"~     Compared curative effect，safety and compliance between concurrent chemoradiotherapy and~     chemo-chemoradio-chemo sequential therapy in locally advanced mid/low rectal cancer.~   "
118013|NCT02022839|"~     We aimed to verify the potencial role of bedside lung ultrasound findings of critically ill~     patients candidates to liberation from mechanical ventilation in predicting weaning outcomes.~     The analysis will be taken in two times: immediately before and at the and spontaneous~     breathing trial.~   "
118014|NCT02022826|"~     This protocol is designed to validate use of the SPM for diagnosis of delayed gastric~     emptying in patients with symptoms of gastroparesis and assess impact of a SmartPill study on~     patient management in the gastroparetic populations. Patients with symptoms of gastroparesis~     will be recruited.~      Patients will undergo concurrent gastric scintigraphy and SPM testing to determine the~     presence or absence of delayed gastric emptying based on predetermined diagnostic cutoffs for~     each technique.~   "
118015|NCT02022813|"~     Having previously demonstrated that supplemental parenteral nutrition to complete an~     insufficient enteral nutrition (EN) between D4 and D8 improves outcome after critical~     illness, by reducing infectious complications, the present trial aims at investigating the~     underlying carbohydrate and protein metabolism changes, as well as the immune and~     inflammatory modulations associated with this improvement.~   "
118210|NCT02020252|"~     The purpose of this research study is to test a touchscreen computer program, which allows~     patients to see information on a computer screen regarding cancer care, and specifically~     clinical trials. The purpose of this research is to help the investigators learn more about~     how to use technology in the medical setting to improve health outcomes.~   "
118016|NCT02022800|"~     In standard care for patients diagnosed with a primary or secondary (metastasis) cerebral~     tumor, there is currently complex clinical situations in which the clinic and Magnetic~     Resonance Imagery (MRI) do not allow for the medical team to arrive at a conclusive~     diagnosis. The therapeutic proposition requires then a delay in additional follow-up of at~     least 3 months in order to clarify the situation, with a potential delay in diagnosis and~     therefore therapeutic care. The contribution of cerebral molecular imagery could allow for~     new additional information to be brought in or to increase the confidence index in the~     diagnosis in order to comfort the therapeutic collective attitude proposed in the~     multidisciplinary meeting (MM).~      3.4-dihydroxy-6-18F-fluoro-L-phenylalanine (18F-FD0PA), dopamine precursor amino-acid,~     Position Emission Tomography (PET), allows for the studying in vivo of the proteic~     transmembrane transport in gliomatous tissue; active transport happens through a~     sodic-independent canal, increased in malicious transformations, and in which kinetics can~     give an indication regarding the development of the primary tumor.~      In MRIs, tumor tissue growth after injecting the contrast product translates to a rupture in~     the Blood-Brain Barrier (BBB), while tumor extraction from the radiopharmaceutical is~     independent of the state of integrity of the BBB and whose only function is metabolic tissue~     activity. This method of imagery thus appears as a promising contribution to conventional~     imagery.~      Furthermore, different to 18F-FDG (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose),~     similar to the largely used glucose in oncologic molecular imagery, exploration of harmful~     glioma in 18F-FDOPA, is not compromised by background noise activity, and is almost useless~     in a healthy cerebral cortex, with the exception of striatal physiological fixation used as a~     level of reference. The best performances in terms of positive and negative predictive value~     were defined in the literature with a tumor/striatum threshold of 1.~      According to the latest and current European recommendations, turning to PET when caring for~     high-level gliomas patients can be proposed in the evaluation of therapeutic responses.~     However, very few studies have evaluated the in-practice current clinical contributions of~     PET and put it into perspective with classic clinical radiological data.~   "
118017|NCT02022787|"~     This study was designed as a pilot study to try and find a Chemokine that may be specific for~     renal cell carcinoma~   "
118018|NCT02022774|"~     The purpose of this study is to evaluate the effects of fimasartan on arterial stiffness in~     patients with hypertension~   "
118019|NCT02022761|"~     This is a single centre, randomized, double-blind, placebo-controlled, single ascending dose~     study, in which the safety and pharmacokinetics of laninamivir octanoate administered by~     inhalation via the TwinCaps® DPI will be assessed in adults with mild or moderate chronic~     asthma.~   "
118020|NCT02022748|"~     A phase I, open-label study comparing the pharmacokinetics, pharmacodynamics, safety and~     tolerability of ticagrelor in hemodialysis patients to healthy subjects with normal renal~     function.~   "
118021|NCT02022735|"~     The purpose of this study is to evaluate the effect of Deep Brain stimulation (DBS) on~     walking in patients with Parkinson's disease that have had DBS. While DBS improves~     Parkinson's disease (PD) symptoms and walking in many patients in some of the patients~     walking problems persist. This study aims to find out what are the best stimulation~     parameters of the DBS in order to improve walking.~   "
118022|NCT02022722|"~     The purpose of this study is to evaluate which treatment option for pelvic floor pain allows~     for improved sexual function.~   "
118023|NCT02022709|"~     The purpose of this study is to evaluate the efficiency of SSRIs（Selective Serotonin Reuptake~     Inhibitor） ,ERP（Exposure and Response Prevention） and the combination of the two therapies~     for OCD(Obsessive-Compulsive Disorder) patients ,at the same time, to find out the biological~     or psychological predictors of treatment response in Chinese population.~   "
118024|NCT02022696|"~     This is a clinical gene transfer study that aims to verify the safety and efficacy of the use~     of the EFS-ADA lentiviral vector to introduce the human adenosine deaminase (ADA) gene into~     the hematopoietic progenitors of patients affected with severe combined immunodeficiency due~     to ADA deficiency. The EFS-ADA vector expresses the human ADA cDNA under the control of the~     elongation factor alpha short promoter (EFS). In addition, this protocol will examine the~     effects of the ADA gene transfer on the immune system of treated patients. Patients with ADA~     deficiency and ineligible for matched sibling allogeneic bone marrow transplantation are~     eligible to participate in the study. To increase engraftment and selected advantage or~     gene-corrected cells, busulfan will be used as a cytoreductive agent. Enzyme replacement~     (PEG-ADA) will be discontinued 30 days after infusion of gene-corrected cells. CD34+~     hematopoietic progenitors will be isolated from the patient bone marrow, peripheral blood or~     cord blood, exposed to lentiviral vector-mediated gene transfer and re-infused into the~     patient through a peripheral vein. Clinical, immunological and molecular follow-up studies~     will assess safety, toxicity, and efficacy of the procedure.~   "
118025|NCT02022683|"~     To compare the clinical outcomes of Endoscopic Lung Volume Reduction using Pulmonx Zephyr~     Endobronchial Valve (EBV) vs. Standard of Care (SoC) in the treatment of heterogeneous~     emphysema patients in a controlled trial design setting.~   "
118026|NCT02022670|"~     The proposed research will determine the effectiveness of nitrite, a naturally occurring~     compound in the body, for improving the health and function of arteries in middle-aged and~     older adults. The study also will provide insight into how sodium nitrite therapy improves~     artery health by determining the physiological mechanisms (biological reasons) involved.~     Overall, the proposed research will provide important new scientific evidence on the~     effectiveness of sodium nitrite for decreasing the risk of developing cardiovascular diseases~     with aging.~   "
118027|NCT02022657|"~     The primary objective of this study is to define the mean, variance, and dose proportionality~     for tenofovir-diphosphate(TFV-DP) in dried blood spots resulting from 33%, 67%, and 100% of~     daily dosing with 200mg emtricitabine and 300mg of tenofovir disoproxil fumarate (as~     Truvada®). With this information, a model will be established to predict adherence rates to~     TFV-DP using DBS. Forty-eight healthy HIV-uninfected adult participants who are at low risk~     for HIV infection will be randomized to one of 6 sequences consisting of two directly~     observed dosing regimens, 33%/67%, 33%/100%, 67%/33%, 67%/100%, 100%/33%, and 100%/67% with~     each dose regimen lasting approximately 12 weeks, separated by an approximately 12 week~     washout period. DBS will be collected at regular intervals, including during the washout. The~     hypothesis of the study is that levels of TFV-DP in DBS will predict adherence rates in the~     preceding 1-3 months.~   "
118028|NCT02022644|"~     This is a dose-toleration study designed to investigate and determine the maximum tolerated~     dose of nanoliposomal irinotecan in adults with recurrent high-grade glioma when administered~     directly into the tumor using a process called convection-enhanced delivery. (CED)~   "
118221|NCT02020109|"~     Retrospective evaluation on the effect of splenic irradiation on clinical and hematological~     response and toxicity in patients with chronic lymphatic leukaemia (CLL).~   "
136513|NCT01780389|"~     The current study examines the effects of milnacipran in patients who have chronic persistent~     knee pain one year or longer after total knee arthroplasty (TKA) to evaluate for a~     pain-relieving effect.~   "
118029|NCT02022631|"~     The investigators will conduct a parallel two-armed, non-inferiority randomized trial~     comparing new alternative formats of summary of findings tables (SoF) tables with current~     formats. The investigators will contact Cochrane review users by email and will ask them to~     fill a questionnaire developed using the Survey Monkey online system. The survey will~     include questions about baseline information (demographic characteristics, background, number~     of visits to the Cochrane Library, familiarity with the GRADE system, etc.). Then,~     participants will be stratified (health professional, guideline developer, researcher) and~     randomly assigned to one of the two SoF table formats, either the alternative (Table A) or~     the current one (Table C). Participants will be asked to answer questions to determine~     understanding, accessibility, and satisfaction with the formats to which they were~     randomized. Finally, the investigators will show them the table format to which they were not~     initially allocated in order to test their preference for either one.~   "
118030|NCT02022618|"~     Objectives: To analyze the influence on the presence of target organ damage renal, cardiac~     and vascular of peripheral and central blood pressure, retinal vessels caliber, oxidative~     stress and polymorphisms of genes VAV-2-3 in hypertensive subjects.~      Methodology: A cross- sectional design we will performed . Population: 486 hypertensive~     patients. Target organ damage will be assessed by tests recommended in 2013 European~     guidelines of hypertension. Blood pressure office and ambulatory, retinal caliber~     vassels,oxidative stress and polymorphisms VAL -2-3 will be measurement.~   "
118031|NCT02022605|"~     Previous studies have demonstrated that coached EMS practice at the beginning of ERCP~     training could improve the trainees' skill. However, it is not known whether continuously~     coached practice using EMS can provide additional benefit.~   "
118032|NCT02022592|"~     A goal directed , demand-driven administration of sedative drugs is an integral part of every~     intensive care treatment. During long-term application of sedatives, Midazolam is the most~     commonly used sedative in Europe.~      One major objective is the problem of oversedation and agitation during an intensive care~     treatment due to the lack of controllability of available substances.~      The Love-Mi RCT investigates the clinical controllability of Midazolam versus the newly~     available intravenous drug Lormetazepam.~   "
118033|NCT02022579|"~     A type of magnetic resonance imaging called diffusion weighted imaging (DWI) will be tested~     to define cancerous from non-cancerous lesions in the breast.~   "
118034|NCT02022566|"~     Physical activity level is measured at baseline and after 3 and 12 months after structured~     information and individually adapted exercise for patients with osteoarthritis in hip or~     knee.~      The hypothesis of this study is that a supported self management of osteoarthritis program~     will increase the level of physical activity in patients with osteoarthritis in hip or knee.~     The second hypothesis is that patients with osteoarthritis in knee will increase their level~     of physical activity more than patients with osteoarthritis in hip.~   "
118035|NCT02022553|"~     AIM OF RESEARCH. The aim of our research is to improve the results of the combined treatment~     of patients with locally advanced rectal cancer using endovascular methods and reservoir and~     plastic surgery.~      TASKS OF RESEARCH.~        1. To assess the immediate and long-term results of combined (chemoradiation and surgical)~          treatment for locally advanced rectal cancer.~        2. To make a comparative evaluation of the results of independent surgical and combined~          (chemoradiation and surgery) treatment of patients with locally advanced rectal cancer.~        3. To examine functional results of surgical treatment with the formation of neosphincter~          and neorectum in patients with colorectal cancer..~        4. To study features of blood supply to the rectum from the pools of the inferior~          mesenteric and internal iliac arteries, using the method of selective angiography, in~          connection with the development of endovascular treatment of rectal cancer.~        5. To develop and introduce into clinical practice method of one-stage selective~          intra-arterial oil chemoembolization of upper, middle and lower rectal arteries in~          patients with locally advanced rectal cancer, who have a contraindication to~          preoperative radiotherapy.~        6. To assess the immediate and long-term results of combined (endovascular and surgical)~          treatment for locally advanced rectal cancer.~        7. To optimize tactics of combined treatment of locally advanced rectal cancer by~          developing an algorithm of using chemoradiotherapy and endovascular interventions in the~          preoperative period.~      NOVELTY OF RESEARCH.~        1. As a result of research will be designed and implemented a new method of selective~          intra-arterial chemoembolization in rectal arteries preoperatively in patients with~          locally advanced rectal cancer.~        2. Substantiated high effectiveness of the proposed technique for the removal of colonic~          obstruction and, as a consequence perform radical surgical treatment of these patients.~        3. First developed dosage and concentration of chemotherapeutic agent and embolic agent for~          safe injection when performing selective intra-arterial chemoembolization of rectal~          arteries.~        4. Developed complex techniques of selective intra-arterial chemoembolization of rectal~          arteries preoperatively in patients with locally advanced rectal cancer.~        5. Will be made a comparative analysis of the postoperative period and the evaluation of~          the quality of life of operated patients Obtained data will be presented for use in~          clinical practice. POSSIBLE APPLICATION AREAS. Results of the research designed for use~          in the treatment process of departments of Coloproctology, oncology, as well as the~          educational process of higher and secondary medical institutions.~      EXPECTED EFFECTIVENESS.~      It is expected that the use of this method of treatment of patients with locally advanced~     rectal cancer in clinical practice will provide pronounced effect:~        1. Medical and social - improving the quality of care, preservation of social activity of~          patients, reducing mortality;~        2. Economic - reducing the time of patients' treatment and reducing the number of~          therapeutic manipulation;~        3. Science and Technology - improving of the training level of medicine workers in the~          treatment of patients with rectal cancer.~   "
118036|NCT02022540|"~     The objective of this study is to assess the safety and tolerability of topical ocular~     PAN-90806 in patients with active, subfoveal choroidal neovascularization associated with~     neovascular Age-Related Macular Degeneration (AMD).~   "
118037|NCT02022527|"~     The combined Antiplatelet and Anticoagulant treatment decreased thrombus formation and~     overall mortality. Also the initiation of an efficacious early anticoagulation protocol is~     important because of its potential impact on the rate of early thromboembolic complications~     after mechanical valve implantation. An important question that remains to be answered is~     whether the combination would be cost effective than Warfarin alone, with a reduction in~     major bleeding. In addition, the knowledge about its cost-effectiveness has not yet been~     established in Egypt. The aim of this trial based economic evaluation is to conduct a~     cost-effectiveness analysis for combination of low-dose Aspirin and Warfarin versus Warfarin~     alone in prosthetic valve patients from the medical provider perspective specially that a~     misconception is still existed between the physicians in Egypt that the cost of complications~     is not worthy so our main aim is to test the cost of complications.~   "
118038|NCT02022514|"~     Clinical trial phase III, prospective, controlled, randomized, open.~      We hypothesize work that patients with chronic coronary occlusion and poor myocardial~     viability who failed to recover ventricular function after subjecting coronary~     revascularization with new techniques of recanalization, could achieve an improvement of~     ventricular function if given further regenerative treatment with mononuclear cells from~     autologous bone marrow.~      To test this hypothesis we designed a prospective, randomized clinical trial in patients with~     recanalized chronic occlusions and ventricular dysfunction.~   "
118039|NCT02022501|"~     The purpose of this study is to assess the safety, tolerability, bioactivity and~     pharmacokinetics of three concentrations of DE-120 after a single intravitreal injection in~     subjects with late stage exudative age-related macular degeneration.~   "
118744|NCT02013284|"~     The purpose of this study is to determine a relationship between a person's flora/bacteria in~     their gut (the intestinal microbiome) and their risk of cardiovascular disease. Investigators~     will look at inflammatory markers in the blood and also look at the genome of the bacteria in~     the gut.~   "
118040|NCT02022488|"~     Investigators evaluated the effect of intranasal ketamine or alfentanil addition to oral~     midazolam for prevention of emergence agitation.Seventy-eight, 1-8 year-old children,~     undergoing urological surgery with sevoflurane anesthesia was included in the study. All the~     children received oral midazolam 0.5 mg/kg 40 minutes before anesthesia induction then~     enrolled to one of the study groups, randomly. Ketamine group (Group MK; n=26) patients were~     given 2mg/kg intranasal ketamine whereas, alfentanil group (Group MA; n=25) were given~     10microgram/kg intranasal alfentanil 8-10 min before the induction of anesthesia. Saline~     group (Group MS; n=27) received intranasal isotonic saline.Parental separation, mask~     acceptance were evaluated with a 4- point scale. Emergence agitation was evaluated with~     Pediatric Anesthesia Emergence Delirium score.~   "
118041|NCT02022475|"~     Primary objective~      -Change in Fatigue Assesment Score (FAS) between the first visit (baseline) and 28 (+maximum~     7) days after oral administration of 100 000 E vitamin D (Cholecalciferol).~      Secondary objectives~        -  Effect of oral administration of vitamin D on serum vitamin D levels (25-Hydroxy-Vitamin~          D = Colecalciferol), PTH, Calcium, and Phosphate as compared to placebo.~        -  Efficacy of vitamin D (Colecalciferol) administration on fatigue using the short~          self-developed FCA-Test~        -  Safety of 100 000 E oral vitamin D (Colecalciferol) administration as compared to oral~          placebo. Laboratoty parameters such as serum calzium and phosphate levels and the number~          of adverse events compared to placebo will be used for safety monitoring.~        -  Efficacy of oral administration of vitamin D (Cholecalciferol) on plasma FGF-23,~          Sclerostin and Klotho levels compared to placebo.~   "
118042|NCT02022462|"~     The mortality rate among people with Serious Mental Illness (SMI) is 2 to 3 times that of the~     general population, meaning that those with a serious mental illness die, on average, 25~     years earlier than those without an SMI. These deaths are largely attributed to preventable~     medical conditions, many of which are more common in the SMI population.~      The Bridge intervention is a peer navigator model that was developed to target factors that~     negatively impact healthcare access, utilization, and outcomes among individuals with serious~     mental illness (e.g., severe mood disorders and psychotic disorders). This intervention~     targets male and female, adult consumers across races/ethnicities and has been utilized by~     Pacific Clinics (Southern California's largest behavioral healthcare agency) and the~     Department of Mental Health of Los Angeles County to improve the health and quality of life~     for their consumers.~      Investigators will test the comparative effectiveness of a peer navigator intervention (the~     Bridge) to treatment as usual. The Bridge navigator intervention is designed to teach SMI~     consumers the skills to engage health care providers and to overcome motivational deficits in~     order to improve their health and healthcare use. The specific aims of this application are:~        1. To use randomized methods to examine the effectiveness of the Bridge intervention on the~          health care utilization, satisfaction with care, health status, and health care~          self-management for a sample of individuals with severe mental illness receiving public~          mental health services in the community;~        2. To use randomized methods to examine the effectiveness of the Bridge intervention on~          psychological and social well-being for a sample of individuals with severe mental~          illness receiving public mental health services in the community.~      Up to 146 participants in an Full Service Partnership (FSP) clinic operated by Pacific~     Clinics will be recruited to participate in an approximately 24 month long study of Bridge~     navigation. Participants will be randomly assigned to either treatment as usual (waitlist) or~     immediate intervention with the Bridge.~      Participants in both groups will complete three assessments (baseline, 6 months, 12 months)~     and statistically compared over time. Staff stakeholders (n = 20) will also be interviewed at~     baseline and every three months of the study in order to ensure that the intervention is~     being implemented appropriately.~   "
118043|NCT02022449|"~     To explore maternal biological (activation of the hypothalamic-pituitary-adrenal axis) and~     behavioral (smoking, sleep behavior, exercise and alcohol use) pathways of~     intervention-related decreases in inflammation. Hypothesis: The intervention group will show~     decreased levels of cortisol and improved health behaviors from pre- to post-intervention~     when compared with the control group. We will also explore whether intervention-related~     changes in these parameters predict symptoms of illness. Exploratory Aim 2. To explore~     psychological pathways of intervention-related decreases in distress among mothers, including~     the perception of social support and the use of behavioral coping strategies that are~     components of the intervention. Hypothesis: Increases in perceived social support and use of~     active behavioral coping strategies will be associated with intervention-related decreases in~     symptoms of depression, anxiety and psychological stress.~   "
118044|NCT02022436|"~     The goal is to non-invasively study the metabolic processes within the aortic wall that are~     thought to explain progression to clinical manifestations of an aortic aneurysm.~      Hypothesis is that the non-invasive imaging of Abdominal Aortic Aneurysm (AAA) with contrast~     ultrasound, coupled with serum biomarker measurements will allow the identification of the~     vulnerable aortic wall and patients who are at risk of AAA growth or rupture.~   "
118045|NCT02022423|"~     With the aging of the American population, the numbers of adults with peripheral arterial~     disease (PAD) will increase significantly over the next several decades. Patients with PAD~     are at increased risk for morbidity and mortality including both cardiovascular and all-cause~     mortality. While regular physical activity reduces risk for vascular events and is~     recommended for treatment of PAD patients, few patients meet recommended goals. Exercise~     programs which increase long-term adherence to walking can be an important contribution to~     PAD treatment. Our Internet-based intervention, with an online community builds on a walking~     enhancement program developed by members of our team and is shown to improve adherence among~     patients with vascular disease such as coronary artery disease (CAD). Using a randomized,~     controlled trial study design, we propose to test an automated Internet-based walking program~     with a social media component, to improve long-term adherence to walking while increasing~     walking distance, and health-related quality of life, among patients with PAD. Participants~     will be randomized to 1 of four study groups: 1) weekly telephone counseling, 2) an~     Internet-based walking program, 3) a combination of telephone counseling and Internet-based~     walking program, or 4) a usual care group. The Internet-based walking program with a social~     media component has been shown to increase both adherence to walking and overall walking~     duration in populations with chronic complex conditions such as CAD and diabetes. There is a~     strong need to develop interventions, easily generalizable to a real-world population, to~     improve the reach of lifestyle interventions which result in improved physical function and~     adherence to regular exercise among complex medical patients. High risk patients such as~     those with PAD (a CAD risk equivalent) stand to benefit the most from such programs.~   "
118046|NCT02022410|"~     The purpose of the study is to prospectively evaluate patients who underwent total knee~     arthroplasty (TKA) using the Cumulated Ambulation Score (CAS)~   "
118047|NCT02022397|"~     General anaesthesia mandates artificial ventilation and tracheal intubation in order to~     provide patients with artificial breathing. Difficulties related to ventilation and~     intubation remain the leading cause of morbidity and mortality in general anaesthesia,~     essentially due to inaccuracies in pre-operative detection of anatomical factors predisposing~     to difficult airways. In this project investigators will develop image and video-processing~     technologies software solutions to allow automatic recognition of anatomical features playing~     a key role in identification of difficult ventilation and intubation, leading to~     modifications in pre-operative anaesthesia management assessment and therefore increase~     patients' safety.~   "
118236|NCT02019914|"~     The purpose of this study is to evaluate the effects of treating Obstructive Sleep Apnea~     (OSA) with continuous positive airway pressure (CPAP) therapy on symptoms of post traumatic~     stress disorder (PTSD). The study hypotheses are that CPAP use will improve PTSD symptoms~     overall and that CPAP use will improve sleep quality and duration, nocturnal symptoms related~     to PTSD, mood, daytime sleepiness, sleep-related quality of life, and general health~     perception.~   "
118049|NCT02022371|"~     The purpose of this study is to carry out very detailed genetic testing on prostate cancer~     cells. The reason to do this is because researchers do not fully understand~        -  How prostate cancer develops~        -  Why some cancer cells spread and others do not~        -  Why some cancer cells respond to treatment and others do not~      Researchers and doctors know that 1 in 3 of the male population over the age of 50 has cancer~     cells in their prostate. However, most of these men will never know they have it and it will~     not affect their quality of life or their life expectancy. However, some cancers can be~     aggressive. These are more likely to spread outside of the prostate and cause problems.~     Doctors do not have an accurate way to tell the difference between aggressive cancer and~     those which will not cause any problems. Even within one prostate some tumours are aggressive~     and others do not cause a problem during the lifetime of a patient. In fact, even within one~     tumour, different cells may behave differently. In other words, one part of the tumour may be~     aggressive and spread, whilst another part of the same tumour does not. This project will try~     to find out more about what makes different tumours and different parts of the same tumour~     aggressive or harmless.~      It is important to find out what makes some cancer cells spread and others stay where they~     are. For the investigators to do this they need to collect fresh samples of cancer tissue~     from the prostate and from different areas of a tumour within the prostate. This is because~     biopsies used to diagnose or exclude cancer by the hospital laboratory are not good enough to~     give investigators detailed genetic information. These biopsies have been put into a chemical~     called formalin which reduces the quality of the genetic information.~      Investigators are therefore asking patients who are undergoing prostate biopsies as part of~     their normal care to allow them to take additional biopsies for the purpose of this study.~     This may be the first time patients are having biopsies. Or, patients may be having biopsies~     after treatment that has been given for the cancer and the doctors are concerned the~     treatment is not working.~   "
118050|NCT02022358|"~     Methotrexate is one of the most effective chemotherapy drugs in the treatment of osteosarcoma~     and some other types of bone sarcoma which are treated the same way as osteosarcoma. However,~     it frequently leads to sore mouth, tummy pain and increased risk of developing infections.~      The investigators try to save or rescue normal cells from the side effects of methotrexate~     by giving a drug called folinic acid. Folinic acid is started 24 hours after methotrexate and~     given regularly until methotrexate levels are really low and not dangerous to normal cells~     anymore. Despite this rescue, side effects are still a problem and many patients are not well~     enough to receive subsequent chemotherapy on time. Almost half of the planned chemotherapy~     cycles are not given on time due to methotrexate side effects.~      In this study the investigators will examine if adding a drug called glucarpidase to folinic~     acid is helpful. Glucarpidase is an enzyme that inactivates methotrexate in the blood stream.~     Lower methotrexate concentration in the blood stream leads to fewer side effects. The~     investigators would like to see if glucarpidase helps patients to have their chemotherapy on~     time, by reducing the side effects of methotrexate.~   "
118051|NCT02022345|"~     To evaluate the introduction of Percutaneous Coronary Intervention without Onsite Surgery in~     the largest state, California (CA) began a pilot PCI program in 6 hospitals without onsite~     cardiac surgery and then compared the PCI results in the pilot hospitals with results in 120~     non-pilot hospitals. The pilot program qualification incorporated appropriate planning and~     rigorous hospital, operator, patient, and lesion selection criteria.~   "
118052|NCT02022319|"~     Background: The main goal of diagnosing thyroid nodules is to differentiate the few malignant~     from the large background of benign lesion. Currently available pre-operative tests are~     unable to rule out malignancy in a subset of patients and diagnostic surgery is necessary.~     Therefore there is a need to develope the available diagnostic tools for the pre-operative~     diagnostic work-up of thyroid nodules.~      The study will investigate a novel ultrasonographic technique called Shear Wave Elastography~     (SWE) in the pre-operative evaluation of thyroid nodules.~      Hypothesis:~      1) SWE is a precise tool for evaluation of thyroid nodules in terms of inter- and~     intra-observer reliability and day-to-day variation.~      The study will be conducted as part of a larger PhD study, and an evaluation of the~     diagnostic value of thyroid SWE will be evaluated in a larger study.~      Perspectives:~      An optimization of the pre-operative risk-stratification and diagnosis of thyroid nodules can~     reduce unnecessary thyroid surgery, with a reduction in morbidity and better use of the~     economic and surgical resources.~   "
118053|NCT02022306|"~     This study consists of two parts, Parts A and B. Part A is a single ascending dose (SAD)~     study in healthy subjects. Part B is a multiple ascending dose (MAD) study in healthy~     subjects.~   "
118054|NCT02022293|"~     Patients with head and neck cancer who underwent irradiation have a higher risk of developing~     severe carotid stenosis, and eventually develop to transient ischemic attack or stroke.~     However, it's still not clear whether early intervene in vascular risk factors is benefit for~     patients after radiotherapy.~      Our study aimed to evaluate the feasibility and safety of atorvastatin for preventing NPC~     patients after radiotherapy from severe carotid stenosis. In a randomized, double-blind,~     placebo-controlled trial, about 324 nasopharyngeal carcinoma (NPC) patients will be enrolled~     from six centers in Guangdong Province and randomized 1:1 to atorvastatin group or placebo~     group.~   "
118055|NCT02022280|"~     In this randomized controlled crossover study, the investigators propose to test the~     hypothesis that proton pump inhibitors (PPIs) increase plasma levels of asymmetric~     dimethylarginine (ADMA), which is a marker of endothelial dysfunction. The authors propose to~     evaluate ADMA concentrations and vascular function analysis in healthy volunteers and adults~     with a history of cardiovascular disease given PPI vs placebo for four weeks each.~   "
118056|NCT02022267|"~     Patients with clubfoot treated with the Ponseti method from a prospective database are~     evaluated using gait analysis including a foot model and a disease specific instrument score~     and compared to a group of healthy children.~   "
118057|NCT02022254|"~     This trial is conducted in Europe and Asia. The aim of the trial is to investigate the~     influence of semaglutide on pharmacokinetics (the exposure of the trial drug in the body) and~     pharmacodynamics (the effect of the investigated drug on the body) of warfarin and~     pharmacokinetics of metformin in healthy subjects.~   "
118058|NCT02022241|"~     Gonadotropin releasing hormone (GnRH) agonist is sufficient for triggering final oocyte~     maturation in GnRH antagonist protocol and can significantly reduce incidence of ovarian~     hyperstimulation syndrome (OHSS) in high-risk patients.~      However, lower oocyte yield was reported in patients with lower luteinizing hormone (LH)~     level post trigger with single injection of GnRH agonist, which might be related to the~     shorter duration and lower amount of LH induced by GnRH agonist.~      Our aim is to study repeated injection of GnRH agonist for preventing OHSS and maintaining~     clinical outcome in high risk patients who receive controlled ovarian stimulation in GnRH~     antagonist protocol.~   "
118130|NCT02021305|"~     Purpose So far anatomical abnormalities (mostly congenital) were, in the majority of the~     patients, associated with urinary track infections. In this study the researchers will try to~     investigate the role of TLRs as molecular interactions between bacterial virulence and host~     response.~      TLRs are important mediators in the development of the natural immunity against bacteria.~     They recognize microbial pathogen associated molecular patterns and alert the host's immune~     system to the presence of invading microbes~   "
118059|NCT02022228|"~     Gonadotropin releasing hormone (GnRH) agonist is sufficient for triggering final oocyte~     maturation in GnRH antagonist protocol and can significantly reduce incidence of ovarian~     hyperstimulation syndrome (OHSS) in high-risk patients.~      However, lower oocyte yield was reported in patients with lower luteinizing hormone (LH)~     level post trigger with single injection of GnRH agonist, which might be related to the~     shorter duration and lower amount of LH induced by GnRH agonist.~      Our aim is to study dual trigger with GnRH agonist and human chorionic gonadotropin (hCG) for~     preventing OHSS and maintaining clinical outcome in high risk patients who receive controlled~     ovarian stimulation in GnRH antagonist protocol.~   "
118060|NCT02022215|"~     The purpose of the study is to determine the safety and efficacy of high and low strength of~     ME1111 solutions compared to the vehicle in the treatment of onychomycosis of the toenail.~   "
118061|NCT02022202|"~     The purpose of this research study is to better understand the reasons why or why not breast~     cancers are destroyed by standard chemotherapy. This information will be used to develop new~     and better cancer therapies.~   "
118062|NCT02022189|"~     This study is being done to obtain pathology reports from all patients in the Dent disease~     registry who have had a kidney biopsy. The investigator will collect the biopsy slides and~     reports in an attempt to determine if they have any common findings.~   "
118063|NCT02022176|"~     The purpose of this study is to determine the effects of sodium nitrate on resting metabolic~     rate, glucose uptake and formation of reactive oxygen species in humans.~   "
118064|NCT02022163|"~     A phase I trial conducted in a single centre, observer-blind, randomized, dose-ranging,~     placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of 2~     intramuscular injections of plant-based H7 VLP Influenza Vaccine administered to healthy~     adults, 18-60 years of age.~   "
118065|NCT02022150|"~     Ascites is a frequent complication of liver cirrhosis, initial treatment consists on~     diuretics intake, however, as the disease progresses this complication becomes more severe,~     consequently other therapeutic options are used.~      Paracentesis is indicated when severe ascites is present and it should be accompanied by~     albumin infusion.~      Nutritional status is generally affected in patients with liver cirrhosis, even more patients~     with severe ascites show decreased energy intake due to gastric compression.~   "
118066|NCT02022137|"~     As an alternative for the treatment of Minimal Hepatic Encephalopathy (MHE) Agave fructans~     have shown prebiotic effects, and have shown to improve function of the digestive system,~     control and induce glycemic effect satiety. Therefore the impact of the fermentation of such~     prebiotic in the gut may contribute to improving health and quality of life of patients with~     MHE.~   "
118067|NCT02022124|"~     Patients will be randomized to receive open-label (honestly described placebo) immediately at~     baseline or be eligible to receive the open-label treatment three weeks after the baseline~     measurements. Therefore all patients will be eligible to receive open-label placebo treatment~     for their chronic low back pain during the course of the study.~   "
118068|NCT02022111|"~     To provide better care and preventive services for people with both depression and diabetes,~     the investigators propose to develop and test whether interventions to reduce depressive~     symptoms can be integrated into routine diabetes clinics in India. The investigators will~     gather feedback from patients in India through focus group discussions and individual~     interviews so they can culturally-adapt a model of combined depression and diabetes care. The~     investigators will then evaluate the effectiveness and costs of this care model in a trial at~     three diabetes clinics in India. It is expected that results from this study can guide how to~     incorporate mental health care into routine diabetes clinics in low-resource settings.~   "
118069|NCT02022098|"~     The use of multiple drugs in a single clinical trial or as a therapeutic strategy has become~     common, particularly in the treatment of cancer. Because traditional trials are designed to~     evaluate one agent at a time, the evaluation of therapies in combination requires specialized~     trial designs. In place of the traditional separate phase I and II trials, this trial uses a~     single phase I/II clinical trial to evaluate simultaneously the safety and efficacy of~     combination dose levels, and select the optimal combination dose.~      Therefore, this is a two part trial of Debio 1143 combined with concurrent cisplatin and~     radiotherapy (CRT) in participants with previously untreated stage III, IVa or IVb head and~     neck cancer. The trial begins with an initial period of dose escalation (Phase I) to~     investigate the maximum tolerated dose (MTD) of Debio 1143 that can safely be given in~     combination with CRT.~      Using the MTD determined in the Phase I portion, the randomized phase II trial in 94~     participants compares Debio 1143 to placebo, both with concomitant CRT. The aim is to~     evaluate the efficacy and safety of Debio 1143.~   "
118070|NCT02022085|"~     The rationale behind this post-market clinical follow-up investigation is to collect data~     regarding the usability and clinical performance of the Baha Attract System in subjects with~     hearing impairment that are candidates for Baha surgery:~        -  to evaluate the efficacy of the Baha Attract System in terms of hearing performance~          compared to the unaided situation and compared to a pre-operative test situation using~          the sound processor on a Baha Softband;~        -  to evaluate the mid- and long-term safety of the Baha Attract System.~   "
118071|NCT02022072|"~     Respiratory failure is the most common cause of death in neuromuscular diseases. The aim of~     this research is to evaluate the thoracopulmonary recruitment by comparison of inspiratory~     vital capacity (VC ins)and inspiratory/expiratory vital capacity (VC ins-ex) with the vital~     capacity (VC) according to pathology and severity of pulmonary damage of patients with~     neuromuscular diseases. The methodology consists in realize VC by support of~     inspiratory/expiratory pressures, while the patient is passive and realizing a maximal~     inspiratory/expiratory effort simultaneously, with the aid of mechanical~     insufflation/exsufflation device (Cough Assist®). The evaluation will last for 30 minutes and~     the non-inclusion criteria are those for an insufflation. The study hypothesis is that long~     term insufflation/exsufflation device use could improve thoracopulmonary mobility.~   "
118131|NCT02021292|"~     Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for~     treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH).~   "
118132|NCT02021279|"~     The primary objective of this study is to assess the safety and effectiveness of MatriStem~     Pelvic Floor Matrix as compared to native tissue repair for the treatment of pelvic organ~     prolapse. Patients are evaluated throughout a 3 year follow-up period.~   "
118072|NCT02022059|"~     Enteral nutrition is the treatment of choice for malnourish patient. Nasogastric tube (NGT)~     is although a common act. Unfortunately, this procedure can be painful. Also, many patients~     will need many NGT re-insertion. Therefore, the investigators need to increase the~     acceptability of this procedure by increasing comfort during NGT passage. Professionals~     guidelines of HAS (recommendations professionnelles de bonne pratiques de soins) and SFNEP~     (Société Française de Nutrition Clinique et Métabolisme) talk about the possibility of using~     local anesthesic without ordering their use. However, NGT tube insertion is often put without~     pre-medication in the face of an accumulating body of evidence indicating that local~     anesthetic prior NGT insertion decrease discomfort of the procedure. On the other hand, these~     studies have been done in the emergency room with NGT of a bigger gauge and for many reasons~     except enteral nutrition.~      The investigators primary objective of this prospective monocentric study is to evaluate the~     efficacy (patient comfort) of lidocaine 5 % spray versus placebo (physiologic serum) before~     NGT insertion in patient needing enteral nutrition, using visual analogue scale. Secondary~     objectives are to evaluate nurse and patient satisfaction using questionnaires, facility of~     NGT insertion using Likert scale, numbers of try, time of procedure, complications like~     tracheal insertion and success of the insertion using thorax x-ray.~      The study will be held in CHU Nice at nutrition unit support. After signed consentment,~     patients will be separate in two groups : group A (lidocaïne spray 5 %) and group B~     (physiologic serum). There will be 2 spray in nostril and 2 in orophagyngeal cavity 2 minutes~     before NGT insertion, which will be done by a competent nurse. Vital signs will be noted at~     the beginning of the procedure and 10 minutes after. At the end, the nurse and the patient~     will have to answer a questionnaire. Pain will be grade using visual analogue scale~     immediately after the procedure. Demographic data and complications will be note by the~     investigator. Finally, thorax X-ray will be done at the end of the procedure. There will be~     34 patients by group. If the investigators find a benefit, this can change their practice and~     guidelines.~   "
118073|NCT02022046|"~     Chronic kidney disease (CKD) and end-stage renal disease are highly prevalent in Taiwan.~     Cardiovascular disease (CVD) is the most common cause of death in children with CKD. Nitric~     oxide (NO) deficiency links CKD and CVD. Asymmetric dimethylarginine (ADMA), a NO synthase~     inhibitor, its level is increased in kidney disease and cardiovascular disease and serves as~     a methylation biomarker.~      In addition to ADMA, uremic environment, hyperhomocysteinemia (Hcy) and oxidative stress may~     affect DNA methylation. S-adenosylmethionine (SAM) is an important human methyl donor.~     S-adenosylhomocysteine (SAH) is demethylated product. Methylenetetrahydrofolate reductase~     (MTHFR), a folate metabolism enzyme can regulate methylation pathway.~      The investigators intend to examine whether ADMA, SAM/SAH ratio, Hcy, and MTHFR gene~     methylation can serve as biosignature to predict CVD in children with CKD children.~   "
118074|NCT02022033|"~     The investigators preliminary data suggests that FOLFOX-A may have equal or superior activity~     as compared to FOLFIRINOX and appears to be better tolerated. Therefore, FOLFOX-A may be a~     better regimen in the adjuvant setting for patients with resected pancreatic cancer. This~     protocol will obtain preliminary data on safety and disease-free and overall survival~     following administration of FOLFOX-A for patients with resected pancreatic cancer.~   "
118075|NCT02022020|"~     This study is being conducted to collect data on the management of gastrointestinal and~     urogenital bleeding events occurring in patients with atrial fibrillation taking dabigatran~     etexilate.~   "
118076|NCT02022007|"~     The objective of the present proposal is to compare the clinical, endocrine and metabolic~     effects of therapy with combination saxagliptin and metformin to saxagliptin and metformin~     monotherapy in women with PCOS and prediabetic hyperglycemia (IFG, IGT or IFG/IGT).~     Saxagliptin is an oral dipeptidyl peptidase IV (DPP-4) inhibitor whose mechanism of action is~     to prolong the duration of blood glucagon-like peptide (GLP-1) and glucose-dependent~     insulinotropic polypeptide (GIP) levels by inhibiting their degradation and thereby~     augmenting insulin secretion. This study will serve as a pilot investigation to open~     perspectives for future studies to explore the potential of combining anti-diabetic drugs~     with different mechanisms of action in in patients with PCOS and impaired glucose regulation~     (IGR), especially ones for whom standard treatment with metformin is less effective.~   "
118077|NCT02021994|"~     The purpose of this study is to verify the accuracy of the 5 blood pressure cuffs, with blood~     pressure monitor device.~      The cuff range is as follows:~      15cm-24cm, 20cm-34cm, 30cm-44cm, 40cm-48cm, and 22cm-42cm~   "
118078|NCT02021981|"~     This quality improvement project is focused on improving hypertension care delivery processes~     in ambulatory clinical practices, 5 in Illinois and 5 in Maryland for a total of 10 practice~     sites.The primary aim of this quality improvement project is to improve blood pressure~     control among patients receiving routine care for hypertension in a diverse group of~     ambulatory clinical practices. A secondary aim is for American Medical Association (AMA) and~     Johns Hopkins Medicine (JHM) quality improvement staff to figure out the best way to help~     clinical practices in achieving improved blood pressure control, including working to~     increase the use of home blood pressure monitoring.~   "
118079|NCT02021968|"~     Dengue viruses can cause dengue illness ranging from a mild illness to life-threatening~     disease. The purpose of this study is to evaluate the protective effectiveness of a dengue~     virus vaccine in healthy adults.~   "
118080|NCT02021955|"~     This clinical trial is designed to determine whether an intervention that provides~     information to primary care providers about gaps in care for their patients recently~     discharged from hospital for COPD can reduce hospital re-admissions and mortality and improve~     their patients' quality-of-life.~   "
118081|NCT02021942|"~     This is a monocenter, single-arm, open label phase II trial evaluating the effect of SOM230~     LAR in adult patients with inoperable primary thymoma and thymoma metastasis (Masaoka~     II-IVa). SOM230 LAR in a dosage of 60 mg is administered i.m. once every 4 weeks. The purpose~     of this trial is a proof of concept.~   "
118082|NCT02021929|"~     The main purpose of this clinical trial is to determine the safety and effects of the study~     drug, sorafenib, in adults diagnosed with hepatopulmonary syndrome (HPS). The study will~     evaluate how well the drug is tolerated and its effect on the level of oxygen in the blood~     and the function of the lung vessels.~   "
118083|NCT02021916|"~     To provide appropriate collection, storage, and distribution of specimens and medical data to~     local investigators who have approved IRB protocols for their specific research purposes.~   "
118133|NCT02021266|"~     This is a single patient expanded access protocol to investigate the effects of a second dose~     of facilitating cell-enhanced hematopoietic stem cell product.~   "
118349|NCT02018445|"~     The objective of this study is to prospectively evaluate the performance of Integra Accell~     Evo3 Demineralized Bone Matrix as an adjunct for instrumented posterolateral spine fusion, as~     compared to local autograft.~   "
118745|NCT02013271|"~     To demonstrate efficacy and safety of the Lutonix® Drug Coated Balloon for treatment of long~     TASC II Class C and D lesions (≥ 14 cm) lesions in the SFA~   "
118084|NCT02021903|"~     Excessive daytime sleepiness (EDS) is observed in 30 to 50 % of patients with Parkinson's~     disease (PD) patients, Dementia with Lewy Bodies (DLB) and Multiple System Atrophy (MSA). It~     is a major complain and represents a socially relevant problem as unintended episodes of~     sleep can also occur while driving for example. Arterial hypotension is frequently observed~     in patients with PD, DLB and MSA and considered as a marker of autonomic failure. Sleepiness~     is known to occur preferentially when patients are having arterial hypotension whatever the~     cause (i.e. postprandial period, administration of hypotensive medication such as dopamine~     agonists). We hypothesize that arterial hypotension is associated with abnormal sleepiness.~     We have observed this association in an on-going epidemiological survey Hyperglycaemia~     induced by oral glucose load - a standardized model simulating food intake during a meal -~     provokes arterial hypotension in the majority of Parkinson's disease patients with~     dysautonomia. It can be hypothesised that sleep attacks in these patients could be mediated~     by this fall in blood pressure.~   "
118085|NCT02021890|"~     to test the metabolic and clinical effects of a 6-month program of dancing in subjects with~     type 2 diabetes and/or obesity, chronically cared for in two diabetes/metabolic units.~     Self-selection of the leisure time activity program was allowed to increase adherence to the~     physical activity programs.~   "
118086|NCT02021877|"~     Adult patients, age ≥ 18 years, with clinically diagnosed mild, moderate or severe brain~     trauma will be asked to participate in the study. This prospective database will consist of~     400 subjects with TBI, 200 from both TUCH and Cambridge Addenbrooke's Hospital. In addition,~     100 controls will be recruited, with 50 from both centres.This study is a prospective~     clinical observational study with detailed data collecting. All patients will be treated~     according to the accepted, standardized, existing guidelines that are based on national and~     international recommendations. New treatment interventions will NOT be evaluated during the~     data acquisition for this study.~   "
118087|NCT02021864|"~     -  Pregnant women in 24-26 gestational week will be recruited.Serum calcium and 25(OH)D~          will be evaluated and women with mild hypocalcemia (serum calcium 8-8.6 mg/dl) and~          25(OH)D less than 30ng/ml will be entered to study. .~        -  Excluding criteria are: gestational diabetes or diabetes before pregnancy, severe~          preeclampsia, chronic hypertension, fetal anomaly, oligohydramnios or polyhydramnios,~          parathyroid disorders, hepatic or renal diseases, malnutrition , use of anti- convulsive~          and immunosuppressive drugs.~        -  Participants will randomly assigned in to two groups of intervention and control groups~          .Randomization will be done by random number generator. Intervention group will receive~          weekly vitamin D3, 50,000 unit for 8 weeks plus daily prenatal multivitamin containing~          elemental calcium 250 mg/day and vitamin D3 400 unit , control group will receive daily~          prenatal multivitamin.~        -  At the time of delivery, serum calcium, 25(OH)D of mothers, maternal weight gain during~          study , Serum calcium and 25(OH)D of newborns and neonatal growth indices ( length,~          weight, head circumference ) will be compared between two groups.~   "
118088|NCT02021851|"~     Postoperative nausea and vomiting (PONV) is a common problem after general anesthesia. The~     incidence can be as high as 80 percent in high-risk patients. Investigators designed this~     randomized, double- blind, single-center study to compare the efficacy of the combination of~     dexamethasone with ondansetron and dexamethasone with aprepitant undergoing laparoscopic~     surgery.~      Seventy American Society of Anesthesiologist (ASA) physical class I-II, age 18-60 years~     patients scheduled for laparoscopic surgery were included in this study. Anesthesia was~     induced with propofol, fentanyl, and rocuronium, and maintained with sevoflurane in oxygen /~     air mixture in all patients. Remifentanil was continuously infused during surgery. Patients~     were randomly divided into two groups. Patients in the dexamethasone and aprepitant group~     (group DA, n=35) received 40 mg aprepitant orally 1 to 2 hours before induction of anesthesia~     and 2 ml saline intravenous (iv) within the last 30 minutes of surgery. Patients in the~     dexamethasone and ondansetron group (group DO, n=35) received an oral placebo identical to~     aprepitant 1 to 2 hours before induction of anesthesia and 4 mg ondansetron iv within the~     last 30 minutes of surgery. All patient received iv 8 mg dexamethasone after induction of~     anesthesia.~      PONV and postoperative opioid consumption were assessed for 24 hours postoperatively. The~     blindly evaluated primary outcome was complete response. The secondary outcomes were~     incidence of nausea, retching or vomiting, the need of rescue antiemetic and opioid~     consumption within 24 hours after surgery. Statistical analyses were performed using~     Mann-Whitney U test, Chi-square test, and Fisher's Exact test. P<0.05 was considered~     statistically significant.Investigators hypothesized that the antiemetic efficacy of the~     aprepitant and dexamethasone combination is superior compared with ondansetron and~     dexamethasone combination following the laparoscopic surgery.~   "
118089|NCT02021838|"~     In collaboration with the National Institute of Justice (NIJ) and the Office for Violence~     Against Women (OVW) the Yale University team will evaluate the implementation process and~     impact of the U.S. Department of Justice's Domestic Violence Homicide Prevention~     Demonstration Initiative. This evaluation seeks to draw critical findings and potential~     lessons from the combined experience of the sites including: 1) how the models work in~     different communities; 2) the barriers and facilitators to implementing the models; and 3)~     outcomes of the model delivery. The evaluation team will also disseminate the findings with~     the goal of informing replication.~   "
118090|NCT02021825|"~     The treatment protocol consisted of 12 mg/m2 MITO intravenous infusions every 3 months for 2~     years. Dosage was adjusted according to side effects. Neurological assessment including the~     determination of the Expanded Disability Status Scale (EDSS) score and ophthalmologic~     evaluations were performed every 3 months and during relapses. Flow cytometric analysis,~     brain and spinal cord MRI was performed at baseline, 6, 12, 18, and 24 months.~   "
118091|NCT02021812|"~     The purpose of this study is to assess the feasibility of the use of the GORE® TAG® Thoracic~     Branch Endoprosthesis to treat aneurysms involving the proximal Descending Thoracic Aorta~     (DTA)~   "
118092|NCT02021799|"~     The purpose of this study is to determine whether a difference exists in the gut, oral,~     vaginal and human milk microbiome of under-nourished pregnant women as compared to healthy~     and obese pregnant women. In addition, the investigators are setting out to determine if a~     micronutrient enriched probiotic yogurt can improve the microbiome and pregnancy outcomes of~     under-nourished pregnant women.~   "
118093|NCT02021786|"~     This study aims to evaluate the effects of a mobile phone-based dietary and physical activity~     intervention on body fatness, dietary intake and physical activity of preschoolers~   "
118094|NCT02021773|"~     The purpose of the study is to determine whether monthly subcutaneous administration of~     LBR-101 is safe and provides migraine prevention in patients with chronic migraine.~   "
118158|NCT02020941|"~     This phase II trial studies how well carfilzomib works in treating patients with multiple~     myeloma in first relapse or refractory to first-line therapy. Carfilzomib may stop the growth~     of cancer cells by blocking some of the enzymes needed for cell growth.~   "
118095|NCT02021760|"~     -  Trial objective: To test the hypothesis that remote per-postconditioning in connection~          with primary PCI will reduce myocardial infarct size patients with STEMI.~        -  Trial Design: Placebo controlled randomized study with parallel groups~        -  Primary Endpoint: Myocardial infarct size expressed as a percentage of the myocardium at~          risk determined by Cardiac Magnetic Resonance (CMR) day 4-7~        -  Efficacy Parameters: Myocardial infarct size expressed as a percentage to the myocardium~          at risk determined by CMR at 6 months.~        -  Global left ventricular function determined by left ventricular ejection fraction~          determined by CMR.~        -  Microvascular obstruction determined by CMR day 4-7. Quantified ECV (extracellular~          volume) in left ventricular as myocardium at risk day 4-7 and remodelling parameters day~          180.~        -  Safety Parameters: Major adverse cardiovascular events.~   "
118096|NCT02021747|"~     Identify a biologic (molecular) basis for the increased susceptibility of cigarette smokers~     to pulmonary TB (Mtb) by testing the hypothesis that smoking reprograms AM polarization~     towards a distinct phenotype associated with impaired host defense function against Mtb and~     that normalization of that phenotype via therapeutic modulation of the Alveolar Macrophage~     (AM) polarization or smoking cessation can restore the anti-Mtb host defense function of AM.~   "
118097|NCT02021734|"~     There are certain categories of diseases which are more prevalent in the Arab world due to~     increased rates of consanguinity in relatively isolated populations. The goal is to discover~     these mutations by using next-generation human genetics tools.~   "
118098|NCT02021721|"~     Hypothesis: To identify new gene mutations that can be related to patients with idiopathic~     male factor infertility.~      Primary Objective: To detect possible genetic abnormalities in families with more than one~     sibling with male infertility.~      Secondary Objective: To evaluate using next generation DNA sequencing in cases of infertility~   "
118099|NCT02021708|"~     The purpose of this study is to learn about the effects of smoking shisha on the lungs, when~     compared to the effects of smoking cigarettes or of not smoking. The investigators hope to~     learn more about how shisha smokers should be monitored and treated once diseased.~   "
118100|NCT02021695|"~     With the assessment of the healthy vs. diabetic and pre-diabetic Qatari population the~     investigators intend to measure the changes in DNA methylation and gene expression in blood~     monocytes and lymphocytes attributed to diabetes, and to evaluate whether theses changes are~     persistent or can be reversed by improving diabetes control.~   "
118101|NCT02021682|"~     Alzheimer's disease (AD) is the most common cause of dementia and currently has no disease~     modifying treatments or simple accurate diagnostic tests. The goal of this project is to~     study how amyloid-beta (a protein thought to cause AD) is made, transported and cleared in~     the human body. Better understanding of these processes may lead to improved understanding of~     AD, earlier diagnosis and a way to evaluate treatment.~   "
118102|NCT02021669|"~     The purpose of this 10 week randomized, placebo-controlled, double-blind clinical trial is to~     determine whether antidepressant augmentation with two grams of EPA omega-3 per day is~     superior to antidepressant therapy alone for major depression in patients with coronary heart~     disease (CHD).~   "
118103|NCT02021656|"~     The primary objectives of this study are to evaluate the efficacy, safety and tolerability of~     treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in~     treatment-naive and treatment-experienced participants with chronic genotype 1 Hepatitis C~     Virus (HCV) infection.~   "
118104|NCT02021643|"~     The primary objectives of this study are to evaluate the efficacy, safety and tolerability of~     treatment with sofosbuvir (SOF)+ ribavirin (RBV), with or without Pegylated interferon alfa~     (Peg-IFNα-2a/ PEG)) in participants with chronic genotype (GT)-1, 2, 3, and 6 Hepatitis C~     virus (HCV) infection.~   "
118105|NCT02021630|"~     This proposal is designed to examine the impact of bariatric surgery on the health of~     patients and their families. The shared environment of spouses/cohabitating partners suggests~     that patients' families are exposed to the extensive diet and lifestyle changes required of~     patients following bariatric surgery.~   "
118106|NCT02021617|"~     -  To evaluate infusion flow rates attainable when using the proximal humerus and proximal~          tibia IO vascular access sites.~        -  To evaluate the intraosseous infusion physiology when using the proximal humerus and~          proximal tibia IO infusion sites.~        -  To further evaluate the relationship between IO and venous blood when used for~          laboratory testing.~        -  To determine the time from IO needle insertion to IO access established.~   "
118107|NCT02021604|"~     Low blood sugars are known to cause brain damage in newborn babies. One of the most common~     causes of low blood sugars persisting beyond the new born period is a condition called~     congenital hyperinsulinism (HI). This is a disease whereby the pancreas secretes too much~     insulin and causes low blood sugars. Twenty to forty percent of these babies will have brain~     damage. There are two forms of this disease. In one form only a small part of the pancreas~     makes too much insulin (focal HI) and in the other, the whole pancreas make too much insulin~     (diffuse HI). If a surgeon could know which part of the pancreas has the focal lesion he~     could remove it and cure the patient.~      The purpose of this study is to investigate whether a new investigational drug called~     Fluorodopa F 18, when used with a PET scan, can find the focal lesion and guide the surgeon~     to remove it, thus curing the patient and preventing further brain damage~   "
118108|NCT02021591|"~     The main hypothesis of this research is that use of an informatics intervention for~     problem-solving in diabetes management, Mobile Diabetes Detective (MoDD), by individuals with~     type 2 diabetes will lead to positive improvements on a number of primary and secondary~     outcomes related to their health and their management of diabetes. The primary outcomes are a~     reduction in individuals' glycolated hemoglobin (HbA1c), improvement in their problem-solving~     abilities, and self-care behaviors. Secondary outcomes include a reduction in individuals'~     fasting blood glucose (BG); improvement in individuals' self-efficacy, and in emotional~     aspect of living with diabetes. We hypothesize that primary and secondary outcome effects~     will be sustained at three months and twelve months. Exploratory outcomes include a decrease~     in individuals' Cardiovascular Risk (Body Mass Index, Blood Pressure, Total, low-density~     lipoprotein (LDL) and high-density lipoprotein (HDL) Cholesterol levels, and Framingham~     Cardiovascular Risk Score). We also hypothesize that improvements in clinical outcomes~     (HbA1c, fasting BG and Cardiovascular Risk) will be mediated by the improvements in~     problem-solving abilities and self-efficacy.~   "
118110|NCT02021565|"~     The CG ASSIST Project is a four-year study for older Veterans with transfer impairments and~     informal caregivers. CG ASSIST is an in-home training program for dyads designed to teach~     Veterans how to safely, skillfully, and (when possible) independently perform Activities of~     Daily Living involving transfers. Experts (OTs) who provide this training will also~     recommend, provide, and install assistive technology devices such as grab bars, bed rails,~     and toileting aids as needed. Research assistants conduct home visits with the dyads pre and~     post intervention to determine the effects of the program on Veteran and caregiver quality of~     life measures (burden, depression, task efficacy, lifespace).~      Half of the couples in this study will receive the training from the expert remotely through~     a tele-video conferencing device. Research assistants will bring the device to participants'~     homes and assist in the training session.~   "
118111|NCT02021552|"~     The specific aim of this is to establish a cohort of severely injured patients admitted to~     our trauma center. Investigators will collect DNA, utilizing discarded blood samples, from~     3000 injury victims in an effort to identify perhaps 50 - 100 single-nucleotide polymorphisms~     (SNP) (out of 1000s) that can be used, when taken together, to identify patients at highest~     risk for developing complicated sepsis and death.~   "
118112|NCT02021539|"~     The hypothesis tested is that the physical changes associated with cervical ripening result~     in a detectable decrease in rigidity. The main objective of this study is therefore to~     determine whether the measured elastographic rigidity of cervical tissues in addition to~     cervix size can be used to predict delivery within the next 48 hours (creation of a~     prognostic score).~   "
118113|NCT02021526|"~     This is a single-site, open-label, phase II trial of C7, a food supplement or medical food,~     for the development of treatment outcome measures for glucose transporter type I deficiency~     (G1D). The primary outcome measures are: 1. Safety and tolerability of C7 as measured by~     changes in comprehensive blood work, including lipid and free fatty acid panels,~     self-reported side effects and clinical exam; 2. Changes in brain metabolic rate by MRI and~     EEG measurements during C7 treatment; and 3. Maintenance of ketosis in G1D patients on~     ketogenic diet, as measured by serial ketone levels during treatment initiation.~   "
118114|NCT02021513|"~     This is a single blind placebo-controlled pilot study involving Systemic Lupus Erythematosus~     and lupus nephritis patients. We propose to recruit and consent SLE patients who will be~     randomized to either receive the study drug, an over the counter fish oil supplement, or a~     placebo that contains olive oil. They will have a baseline metabolomic profile (blood test),~     nutritional assessment, fatigue severity scale, quality of life assessment, and SELENA-SLEDAI~     lupus disease activity assessments completed at the time of study medication distribution.~     Once 6 months of either the study drug or placebo is completed, then pill counts, assessments~     of experience/adherence (including side-effects, adverse effects, complaints, and~     un-blinding), and repeat nutritional assessment, fatigue severity scale, SELENA-SLEDAI, and~     metabolomic profile will be assessed. The study duration for each patient will be 6 months~     from initiation of the study drug. It is hypothesized that patients receiving the fish oil~     supplement will have improvement in their metabolomic profile. Additionally it is~     hypothesized that patients receiving the fish oil supplement will have improvement in disease~     activity, fatigue, and quality of life assessments.~   "
118115|NCT02021500|"~     A study to collect survival data on patients previously enrolled in Abraxane pancreatic~     cancer study CA046.~   "
118116|NCT02021487|"~     The study aims to investigate the presence of a substance in the blood called prokinecitine,~     which is released by the heart when a heart attack occurs. Several venous blood samples at~     the arm are withdrawn at admission, H6, H12, H24, H48 and H72 in order to measure the~     concentration of this substance in the blood. The usefulness of this new blood marker is~     going to be determsined to seek if it would be of help to better diagnose or estimate the~     gravity of heart infarction after a heart attack.~   "
118117|NCT02021474|"~     This is a prospective multi-center, randomized, double-blind, two treatment period,~     placebo-controlled study in subjects with migraine headache requiring prophylactic treatment.~     The patients will be randomized to receive either histamine dihydrochloride sc or placebo~     (matching vehicle only) sc for 16 weeks. The safety and efficacy outcome measures will be~     assessed at selected dosing segments during the 16 week treatment phase and 4 weeks (week~     20), 8 weeks (week 24) after the last Injection.~   "
118118|NCT02021461|"~     The purpose of this study is to investigate the taste preference in children of 3 different~     flavours of the ESL oral suspension.~   "
118119|NCT02021448|"~     Investigate whether the course of an isolated nocturnal alveolar hypoventilation can predict~     the future occurrence of obesity-hypoventilation syndrome (OHS) in obese subjects~   "
118120|NCT02021435|"~     1. Research background~           - High blood pressure is one of the most important risk factors to cardiovascular~          diseases (CVDs). Reducing population blood pressure can control CVD incidence and lower~          mortality effectively. Much research has proven that adjusting for Na and K intake level~          can reduce blood pressure. According to the China Salt Substitute Study, the systolic~          blood pressure of intervention group which used salt substitute is 5.4 mmHg lower than~          that of control group. Life expectancy in Tibet is 67 years old. It is estimated that~          the use of salt substitute among population in Tibet can reduce total mortality in Tibet~          by 20%. China Salt Substitute Study in Tibet (CSSS-Tibet), found that salt substitute is~          effective in lowering both systolic and diastolic blood pressure and offers a simple,~          low-cost approach for hypertension control among Tibetans in China (unpublished~          results). However, the study focused on hypertensive patients, the effectiveness of~          hypertension control by providing free salt substitute to the entire population remains~          unknown, and a large-scale trial is needed.~        2. Objectives~           - Primary objective is to observe the effect of providing salt substitute on population~          blood pressure in Tibet. Secondary objective is to observe the effect of such~          intervention on population mortality, cardiovascular mortality and life expectancy. In~          addition, the data collected from high-risk population (sub-group) in the study will be~          used in China Salt Substitute and Stroke Study (SSaSS). Also, serum cholesterol and~          random blood glucose of people over 60 in Tibet will be collected.~        3. Method~             -  The study is a open, cluster-randomized, controlled trial.~             -  30 villages with 15 to 35 households each and a distance of at least five~               kilometers in between will be selected from Damxung county and Maizhokunggar~               county. The two counties have an average altitude of over 4000 meters in Tibet~               Autonomous Region.~             -  All selected villages will be randomly assigned to intervention group or control~               group on a 1:1 ratio.~             -  All household in the selected villages will be recruited if they meet the~               eligibility criteria. Approximately 4,500 participants will be enrolled~             -  Intervention group receives free salt substitute. Control group will continue to~               buy their own normal salt. Both group will receive the same health education on~               salt reduction.~        4. Outcome - Primary outcome is blood pressure. Secondary outcomes include total mortality,~          cardiovascular disease mortality, life expectancy, serum cholesterol level of people~          over 60, and random blood glucose level of people over 60.~   "
118121|NCT02021422|"~     The study's overall objectives are to evaluate the safety of anakinra in combination with~     standard chemotherapy regimens in patients with pancreatic ductal adenocarinoma, as well as~     to collect preliminary immune modulation and clinical activity information, overall survival,~     and serious adverse events related to the study drug.~   "
118122|NCT02021409|"~     Anaemia is a condition in which blood has a lower than normal number of red blood cells. It~     can also occur if red blood cells do not contain enough haemoglobin, an oxygen carrying part~     of blood. Anaemia is common in patients with chronic kidney disease. Healthy kidneys produce~     a hormone called erythropoietin, which stimulates the bone marrow to produce the proper~     number of red blood cells needed to carry oxygen to vital organs. Chronic kidney disease is a~     general term that means that the kidneys are not functioning to their full potential. The~     study drug, BAY85-3934, is being evaluated as a drug to increase the body's ability to~     produce erythropoietin.~      The purpose of this study is to find out if the study drug, a tablet taken orally, is safe~     and effective for the treatment of anaemia associated with chronic kidney disease.~      The study will enroll 120 patients at multiple locations in Europe, Asia and Australia.~     Participation will involve a screening visit and between 12 and 15 study visits scheduled~     over a period of approximately 5 to 7 months. The estimated total duration of study treatment~     will be 16 weeks. During these scheduled visits patients will undergo a number of procedures~     to confirm efficacy and safety of the study drug, including measurement of heart rate and~     blood pressure, physical examination, Electrocardiogram and blood/urine sample collection for~     laboratory tests.~      The study will be conducted at 3 hospitals in the UK. Bayer HealthCare AG is funding this~     research.~   "
118123|NCT02021396|"~     The main objective is to show that splenic embolization improves salvage rate one month in a~     population of splenic trauma patients closed with a high risk of hemostasis of splenectomy~   "
118124|NCT02021383|"~     Investigators are conducting a randomized controlled trial with overweight and obese college~     students on the University of Minnesota campus. The primary outcome will be weight loss~     measured 12 months after study enrollment (corresponds to 10 months after the end of~     treatment).~   "
118125|NCT02021370|"~     Anaemia is a condition in which blood has a lower than normal number of red blood cells. It~     can also occur if red blood cells do not contain enough haemoglobin, an oxygen carrying part~     of blood. Anaemia is common in patients with chronic kidney disease. Healthy kidneys produce~     a hormone called erythropoietin, which stimulates the bone marrow to produce the proper~     number of red blood cells needed to carry oxygen to vital organs. Chronic kidney disease is a~     general term that means that the kidneys are not functioning to their full potential. The~     study drug, BAY85-3934, is being evaluated as a drug to increase the body's ability to~     produce erythropoietin.~      The purpose of this study is to find out if the study drug, a tablet taken orally, is safe~     and effective for the treatment of anaemia associated with chronic kidney disease.~      The study will enroll 120 patients at multiple locations in Europe, Asia and Australia.~     Participation will involve a screening visit and between 12 and 14 study visits scheduled~     over a period of approximately 5 to 7 months. The estimated total duration of study treatment~     will be 16 weeks. During these scheduled visits patients will undergo a number of procedures~     to confirm efficacy and safety of the study drug, including measurement of heart rate and~     blood pressure, physical examination, Electrocardiogram and blood/urine sample collection for~     laboratory tests.~      The study will be conducted at 5 hospitals in the UK. Bayer HealthCare AG is funding this~     research.~   "
118126|NCT02021357|"~     The project aims to assess the effects of treatment proprioceptive through the use of~     hyperboloid on the intensity of pain, muscle activity, severity and joint mobility in~     subjects with TMD. Treat will be a blind randomized clinical trial. Will be recruited~     volunteers aged between 18 and 40 years, with myofascial pain and arthralgia according to the~     Research Diagnostic Criteria for Temporomandibular Disorders (RDC / TMD), being randomly~     divided in two different groups, the first group constituted by treatment with hyperboloid~     associated with the exercise of proprioceptive tongue on the hard palate and the second~     group consists of treatment with hyperboloid. The Treatment protocols will be applied for 12~     sessions, the volunteers will be evaluated in three stages: before applying the treatment,~     immediately after the first session and after the last session~   "
118127|NCT02021344|"~     Most college students with mental disorders do not receive treatment, and over 80% of those~     who die by suicide have never made contact with campus mental health services. Knowledge,~     stigma, and other health beliefs represent significant barriers to help-seeking for many of~     these students. However, there have been no large-scale intervention studies for reducing~     these barriers to mental health treatment on college campuses. This project will fill this~     gap by determining whether a community mental health education program, Mental Health First~     Aid (MHFA), is an effective method to increase number of students who seek mental health~     services on college campuses. MHFA is an international, 12-hour training program that has~     been shown to increase knowledge of mental illnesses and their treatments, decrease stigma,~     and increase helping behaviors in community members. However, it has not been tested in a~     college setting in the United States. To determine the effectiveness of MHFA in US colleges,~     the proposed project will involve a randomized control trial of the MHFA training program on~     32 campuses representing a range of higher education institutions, from community colleges in~     rural areas to research universities in large, urban areas. The MHFA training program will be~     administered to peer supports such as residential advisors. Administrative data from campus~     mental health services and pre- and post-intervention surveys will be used to collect outcome~     data on service utilization, knowledge, attitudes, and other measures. Data analyses will~     focus on identifying changes in students' behaviors, knowledge, and attitudes toward mental~     illnesses that can be attributed to the MHFA training. In addition to testing a novel and~     timely mental health intervention for college students, this project will result in improved~     data collection measures for college populations, and will lay the foundation for stronger~     connections and future collaborations between diverse campus communities. If the MHFA program~     is successful in reducing stigma and increasing general on-campus awareness and early~     treatment of emerging mental health problems, then it may provide a cost-effective means for~     enabling more students to seek early treatments for developing mental health problems.~   "
118128|NCT02021331|"~     The purpose of this study is to compare two different techniques of placing dental implants:~     1) removing the tooth and placing the implant immediately and 2) removing the tooth and~     placing both the implant and a temporary crown immediately. Both procedures currently are~     accepted methods for replacing missing teeth but direct comparisons of the two procedures are~     lacking. The results of this study should aid clinicians in selecting the best implant~     placement technique for their patients.~   "
118129|NCT02021318|"~     This study is conducted to explore a new therapy for anemia in patients with chronic kidney~     disease. Anemia is a reduced number of red blood cells or hemoglobin. Hemoglobin (which~     contains iron) is important for the transport of oxygen in your blood. The purpose of the~     study is to see if Roxadustat is effective and safe to treat anemia in patients with chronic~     kidney disease. Roxadustat will in this study be compared to darbepoetin alfa, a commercially~     available medicine for treatment of anemia (tradename Aranesp).~   "
118561|NCT02015689|"~     The purpose of this study is to examine the impact of different message framing (i.e.,~     communication strategies) on parents' intentions to vaccinate their infants for measles,~     mumps, and rubella. We hypothesize that information specifically emphasizing various benefits~     of MMR vaccination will have different impacts on parents' reported levels of intention.~   "
118134|NCT02021253|"~     Surgical resection is one of the curative treatment modalities for HCC. Limits are~     postoperative septic and liver functional complications related to an increase in bacterial~     translocation and systemic endotoxemia. Bacterial translocation is a passage of bacteria and~     bacterial degradation products from the intestine to the portal circulation. The endotoxemia~     secondary to bacterial translocation, stimulates endothelial production of nitric oxide (NO).~     NO is also a potent inducer of membrane instability, responsible for an increase in the~     permeability of the vascular endothelium and intestinal mucosa, possibly contributing to a~     worsening of bacterial translocation.~      Probiotics are live microorganisms which when administered in adequate amounts, provide a~     health benefit on the host ((Health and Nutritional Properties of Probiotics in Food~     Including Powder Milk with Live Lactic Acid Bacteria - Cordoba Argentina October 2001). Data~     from experimental and clinical literature show a significant effect of probiotics on the~     improvement of liver function and a decrease in infectious complications in patients with~     chronic liver disease. The proposed study would evaluate the effect preventive and~     therapeutic in a population of surgical patients, in whom the intestinal portal and hepatic~     inflammation promotes postoperative complications.~   "
118135|NCT02021240|"~     Low dose sub-anaesthetic dose of ketamine has been shown to reduce postoperative pain and~     analgesic consumption. However, due to the heterogeneous results, the standard dosing regimen~     has not been available. Recently, its effect in postoperative outcomes and the development of~     post-operative surgical pain has also been suggested.~      Ketamine has been shown to reduce post-operative early inflammation especially serum IL-6.~     Therefore, study in its effects in post- operative pain and outcomes due to inflammation is~     suggested. Only few clinical studies assessed post-operative pain are related to~     inflammation.~      Pain after third molar surgery is a good model of postoperative acute inflammatory pain.~      A previous study showed that there was no benefit to administer ketamine before or after oral~     surgery for pain relief. However, other studies demonstrated that ketamine used as sedative~     or local ketamine in third molar surgery could reduce postoperative dental pain, swelling and~     trismus.~      Postsurgical facial oedema is difficult to quantify accurately as it is three dimensional.~     Over the years, various measurement techniques have been tried to measure oedema objectively.~     These include direct linear measurement using tape or flexible rulers across fixed soft~     tissue landmarks, standardized stereophotographic measurements, computerized tomography (CT),~     magnetic resonance imaging (MRI), ultrasonography (US) and three - dimensional (3D) laser~     scanning. Recently, three dimensional image reconstructions using a reversed engineering~     technique has been developed and is used in the manufacturing industry. This technology could~     be applied in a clinical setting for monitoring soft tissue changes.~      In this study, the investigators will aim to study the use of sub-anaesthetic dose of~     ketamine in post-operative dental pain and recovery outcomes.~      The investigators hypothesise that post-operative pain after Bilateral Third Molar under~     General Anaesthesia is less in patients receiving sub-anaesthetic does of ketamine before~     incision. The magnitude of this effect will be compared with a positive control group~     (dexamethasone) as well as a placebo group (normal saline). Further, the investigators aim to~     demonstrate whether ketamine can reduce post-operative facial oedema and other post-operative~     outcomes.~   "
118136|NCT02021227|"~     The occurrence of an acute respiratory failure necessitates mostly admission to ICU and~     mechanical ventilation (MV). Rapid and safe discontinuation of MV should be the objective for~     the majority of patients. Many reasons may contribute to weaning , extubation failure and~     prolongation of MV. Critical illness myopathy, induced by immobilisation and prolonged MV,~     may represent a main factor and early rehabilitation may reverse these conditions and improve~     the success of weaning from MV.The objective of this study is to evaluate the effect of an~     early chair sitting (while the patient is awake but still mechanically ventilated) on weaning~     from mechanical ventilation and ICU mortality.~      Methods: Chronic respiratory failure patients with an acute decompensation and requiring MV~     for more than 48 hours will be randomized to 2 groups at the initiation of weaning schedule:~     the studied group (20 patients): chair-sitting group will be transferred from bed to arm~     chair for at least 1 hour and once a day; the control group will stay in bed until~     extubation. Ventilator free days, extubation failure, nosocomial infections, ICU mortality,~     ICU length of stay are assessed and compared between groups. Expected results: Early chair~     sitting would decrease MV duration, number of extubation failure, nosocomial infections and~     ICU mortality. Feasibility and safety of this intervention will also be evaluated and also~     the related work load.~   "
118137|NCT02021214|"~     In the present study, investigator will investigate the effects of methylphenidate (40 mg) on~     mPFC activity in healthy male volunteers during fear extinction using functional magnetic~     resonance imaging (fMRI). Additionally, investigators will examine the effects of~     methylphenidate during aversive interoceptve arousal. The present study will help to identify~     brain structures and networks involved in anxiety and will give insights for methylphenidate~     as a possible adjunct to behavioral therapy for patients with anxiety disorders. Further,~     this study may provide important information about the possible use of fMRI to help the~     development of drugs for the treatment of anxiety disorders.~   "
118138|NCT02021201|"~     This comparison is made between the effects of sertindole and risperidone on vulnerability~     indicators in schizophrenia. More specifically: the effects of these two antipsychotic~     compounds on basic processing of incoming information is studied. The investigators expect~     that the newer antipsychotic sertindole to be more effective in restoring information~     processing in schizophrenia patients than risperidone.~   "
118139|NCT02021188|"~     This VISION study aims to investigate the role of inflammation in atherosclerosis using 68Ga-~     DOTATATE PET, and to validate 68Ga-DOTATATE PET imaging for the detection and quantification~     of vascular inflammation in the aorta, coronary and carotid arteries. This study will test~     the hypothesis that in subjects undergoing carotid endarterectomy for symptomatic plaques,~     there will be a positive correlation between carotid artery 68Ga-DOTATATE PET signal and the~     underlying degree of carotid inflammation measured by immunohistochemical analysis.~   "
118159|NCT02020928|"~     Setting: Oral mucositis is a very common complication of cancer treatment, accounting, often~     at increased risk for infections and even the interruption of treatment, interfering with the~     prognosis of the disease. The low intensity laser therapy has been proposed as an alternative~     for the treatment and prevention of this side effect, with good results in terms of clinical~     and functional, speeding up the process of wound healing and reducing pain.~      Objective: To evaluate the effectiveness of using low power laser in the prevention of oral~     mucositis in patients with hematological cancer, undergoing chemotherapy for bone marrow~     transplantation.~      Methods: There will be a Clinical Trial Randomized, double-blind study to evaluate the~     effectiveness of using low power laser in the prevention of oral mucositis in patients with~     hematological cancer, undergoing chemotherapy for bone marrow transplantation. Participate in~     the study, patients who are in the condition mentioned above accepting participate and have~     aged over 18. Will be excluded from the study patients who have autoimmune disease, which~     present sensitivity to laser or who have already started treatment for oral mucositis prior~     to this study.The study variables are:-independent variable: whether or not the red laser of~     low power-dependent variables: oral mucositis, degree of mucositis, chemotherapy regimen,~     type of blood cancer. For determining the association between the independent variable and~     the dependent will be used chi-square tests of association (Pearson) and Fisher's exact test,~     if necessary. Will calculate the risk ratio (RR) as a measure of relative risk, with the~     confidence interval at 95% (IC95%).Also be calculated NNT (number needed to treat to obtain~     benefit) and NNH (number needed to harm getting). Will be adopted a significance level of 5%.~     The project was approved by the Ethics and Research iMIP. All patients will be appropriately~     informed about the objectives of the project and will only be included if they voluntarily~     agree to participate by signing the consent form.~      Keywords: laser, prevention and control; oral mucositis, bone marrow transplant.~   "
118140|NCT02021175|"~     Cigarette smoking remains the leading preventable cause of morbidity and mortality in the~     United States. In Los Angeles, rates of morbidities due to cigarette smoking follow~     prevalence. While the rate of cigarette smoking in Los Angeles County among youth is at~     historic lows, prevalence is not uniform: Cigarette smoking is pervasive among residents who~     have significant economic disparities. Prevalence is also among the highest in the world for~     Korean school-aged youth and substantially higher numbers of Korean American youth smoke~     cigarettes. To date, smoking prevention efforts in Korea have had mixed results as they are~     not interesting to youth and are not interactive.~      This project will assess an interactive, culturally adapted, tailored smoking cessation~     intervention delivered through the internet and cell phone. Using technology, the~     investigators seek to increase the reach and access of our intervention and facilitate~     cessation without in-person sessions, a factor that limits smoking cessation interventions~     for youth. Youth are energetic users of electronic media, lending support to the delivery of~     treatment through technology.~      The investigators predict that subjects assigned to the intervention will demonstrate~     statistically higher rates of smoking abstinence and longer retention in the cessation~     program compared to those assigned to the standard of care condition. Subjects reporting~     higher levels of smoking exposure, lower motivation, poor mental health, disadvantaged~     neighborhoods, and lower levels of acculturation to American culture will also have lower~     quit rates at each follow-up visit.~   "
118141|NCT02021162|"~     This study aims to assess the effect of Gilenya on brain pathology and cognitive impairment~     over 6, 12, and 24 months in patients with relapsing MS using MRI, clinical data, and~     neurological assessments. Healthy controls will also be followed over 6, 12, and 24 months~     using the same measures.~   "
118142|NCT02021149|"~     According to the 2005 National Comorbidity Survey-Replication study, approximately 20.9~     million American adults, or 9.5 percent of the population over the age of 18 suffer from mood~     disorders including major depressive disorder, chronic, mild depression and bipolar disorder.~     Major depressive disorder (MDD) is predicted to be the second leading cause of disability~     worldwide by the year 2020; sub-clinical mood disturbances impact many additional people and~     are a major reason people seek psychotherapy services. The economic burden of depression in~     the United States is significant: $83.1 billion in 2000 and increasing. Much of this burden~     comes from the high rate of sub-optimal treatment outcomes associated with the disorder.~     Indeed, only 50% of MDD patients recover in less than 12 weeks with adequate treatment, and~     up to 20% of patients will fail to adequately respond to all currently available~     interventions. Moreover, current treatments come at the cost of significant central nervous~     system (CNS) side effects, further highlighting the need for more effective treatments with~     fewer side effects. To address these pressing clinical issues, the investigators will conduct~     a placebo controlled, clinical trial to determine if Whole Body Hyperthermia (WBH) enhances~     the effects of psychotherapy compared to psychotherapy alone in medically healthy patients~     with moderate to severe mood disorders. The investigators plan to recruit a sample of 24~     medically healthy individuals with mood problems who will be randomized to examine whether~     WBH enhances the effects of psychotherapy. To determine acute and sustained effects of WBH~     +psychotherapy on mood disorders, the study will include basic psychiatric~     questionnaire-based assessments at three therapy sessions prior to a single session conducted~     while receiving one of two intensities of WBH treatment. Subjects who elect not to conduct a~     therapy session in the WBH chamber will still be able to complete study questionnaires at all~     therapy sessions. This study challenges the existing paradigm by determining if peripheral~     afferent sensory pathways can be accessed to enhance the treatment of mood disorders and thus~     avoid problems of exposing all of the brain to non-selective drugs.~   "
118143|NCT02021136|"~     The purpose of the study is to evaluate the superiority of Rebel Reliever® knee brace +~     standard treatment versus standard treatment alone in terms of last 24-hour pain relief after~     6 weeks. in patients with medial knee osteoarthritis.~   "
118144|NCT02021123|"~     Because anidulafungin is generally well tolerated and appears to have limited interaction~     with other drugs, it is a potential important agent in the treatment of invasive fungal~     infections. Although anidulafungin is approved for the treatment of invasive candidiasis in~     adult non-neutropenic patients, dosing guidelines for anidulafungin in (morbidly) obese~     patients are not available. Subsequently, the pharmacokinetic profile of anidulafungin (as~     well as other echinocandins) in this specific patient population is still largely unknown.~     During endoscopic gastric bypass surgery, patients are more prone to various kinds of~     infection, justifying the prophylactic use of anidulafungin in this specific cohort of~     patients.~      To build a valid pharmacokinetic model, obese patients with a BMI ≥ 40 undergoing endoscopic~     gastric bypass surgery will receive a single dose of 100 mg anidulafungin (besides standard~     anti-bacterial prophylaxis) and a PK-curve will be drawn. These PK-values can then be~     compared to the pharmacokinetics in a normal-weight group.~   "
118145|NCT02021110|"~     Rationale: Polycystic liver disease (PLD) is a rare disorder characterized by >20~     fluid-filled hepatic cysts. Polycystic livers are present in the combination with renal cysts~     as a manifestation of autosomal dominant polycystic kidney disease (ADPKD), or isolated in~     the absence of renal cysts as autosomal dominant polycystic liver disease (ADPLD or PCLD).~     PLD patients are confronted with symptoms caused by the mass effect of their polycystic liver~     every day for the rest of their life. There is no standard therapeutic option for symptomatic~     PLD patients. Current options are fairly invasive or their efficacy is only moderate.~      Preliminary data in our research lab have shown that ursodeoxycholic acid (UDCA) inhibited~     the proliferation of polycystic human cholangiocytes in vitro through the normalization of~     the intracellular calcium levels in cystic cholangiocytes. The investigators also found that~     daily oral administration of UDCA for 5 months to PCK rats, an animal model of ARPKD that~     spontaneously develops hepato-renal cystogenesis, resulted in inhibition of hepatic~     cystogenesis.~      The investigators hypothesize that UDCA is an effective therapeutic tool in reducing liver~     volume in PLD.~      Objective: First, to demonstrate whether UDCA-therapy is effective in reducing total liver~     volume in PLD patients. Second, the investigators want to assess if UDCA modifies quality of~     life. Finally, the investigators want to assess safety and tolerability.~      Study design: International, multicenter, randomized, controlled trial Study population: 34~     subjects (18 ≤age ≤ 80 years) suffering from symptomatic polycystic liver disease with~     underlying diagnosis of (PCLD or ADPKD), defined as ≥ 20 liver cysts on CT-scan and liver~     volume of ≥ 2500. Symptomatic is defined as ECOG-PS ≥ 1 and having at least three out of ten~     PLD symptoms.~      Intervention: The patients will be randomized (1:1) into two groups. One group of patients~     will receive 15-20mg/kg/day UDCA for 24 weeks. The other group will receive standard care.~      Main study endpoint: Proportional change of total liver volume in UDCA treated patients~     versus non treated patients, as assessed by CT at baseline and 6 months.~      Main secondary outcome variables:~        -  To demonstrate whether UDCA-therapy changes absolute total liver volume~        -  To demonstrate whether UDCA-therapy changes gastro-intestinal symptoms measured by a~          GI-questionnaire~        -  To demonstrate whether UDCA-therapy changes quality of life as measured by SF-36~        -  To demonstrate which proportion of patients has any reduction in total liver volume~          after 24 weeks~        -  To demonstrate whether UDCA is well tolerated~        -  To demonstrate whether UDCA-therapy changes absolute total kidney volume (TKV).~   "
118146|NCT02021097|"~     The purpose of this study is to evaluate the contraceptive efficacy and safety of an oral~     contraceptive containing a combination of LNG 100mcg/EE 20mcg compared to LNG 150mcg/EE 30~     mcg.~   "
118160|NCT02020915|"~     Ultrasound guided placement of the knife intersphincteric increases accuracy and safety~     during sphincterotomy. Secondly 3-D ultrasound visualizes that the internal anal sphincter is~     divided.~   "
118161|NCT02020902|"~     This is a post-marketing surveillance study on a marketed cetrizine hydrochloride~     formulation.~   "
119264|NCT02006472|"~     This is a multicenter, multinational, randomized, parallel-group, double-blind,~     placebo-controlled, does range finding study to compare the efficacy and safety of different~     doses of pridopidine versus placebo in the treatment of motor impairment in Huntington's~     Disease (HD).~   "
118147|NCT02021084|"~     Colchicine is the drug of choice to treat patients with Familial Mediterranean Fever (FMF ),~     some of the patients treated with colchicine may suffer from gastrointestinal (GIT) adverse~     effect such as diarrhea and abdominal pain especially in the higher dose.~      5-10% of the patients with FMF that have been treated with colchicine may have partial or no~     response to this therapy.~      Aim of our study: the aim of our study is :.1to evaluate the efficacy of probiotics in~     reducing the number of adverse effect in patients with FMF that are being treated with~     colchicine and suffering from GIT adverse effect.~      .2 To evaluate the efficacy of probiotics in reducing the number of FMF attacks in children~     with FMF that has been treated with colchicine with only partial response.~      Methods: the study will be done among children (5-17 years old) with FMF that are currently~     followed in the pediatric rheumatology clinic at Mayer children hospital Israel Haifa that~     are being treated with colchicine and suffering from either GIT adverse effect or partial~     response to colchicine.~      The study is design to be double blind placebo control, in the first 3 month patients will be~     with no therapy and will be required to record all there FMF episodes and their GIT adverse~     effect, in the second period the patients will be randomly divided into two groups 1.patients~     that will received placebo (group 1) and the 2. Probiotics group - patients will received~     probiotics (Bio -25 including 11 types of bacteria L.acidophilus, B.bifidum , L.rhamnosus,~     L.lactis, L.casei, B.breve, B.thermophilus, B.longum, L.paracseis, L.plantarum, B.infantis),~     both for three month, during this period patient will be required to record their~     gastrointestinal symptoms and other symptoms that may be related to FMF.~   "
118148|NCT02021071|"~     Philips Healthcare has added a virtual path planner to the current commercially available~     XperGuide software platform and that has the potential to significantly reduce dose during~     image-guided needle interventions.~   "
118149|NCT02021058|"~     Multinational, multicenter, clinical trial. To evaluate the effect of an experimental formula~     on GI symptoms and associated behaviors in unsettled infants with parent-reported feeding~     intolerance~   "
118150|NCT02021045|"~     There is increasing evidence that renal replacement therapy (= continuous veno-venous~     hemodialysis) generates cerebral microembolism which is detectable on transcranial Doppler~     ultrasound.~      The aim of this study is to monitor patients with transcranial Doppler under two conditions:~     during hemodialysis and in a hemodialysis-free interval (in each period cerebral embolic load~     is detected during 30 minutes).~      The study hypothesis is that during hemodialysis the cerebral embolic load is significantly~     higher than in the hemodialysis-free interval.~   "
118151|NCT02021032|"~     The primary objective of the post-marketing study is to collect safety and effectiveness data~     for 5 years on subjects treated with Prolieve®. The collection of 5-year safety information~     will be used to evaluate the occurrence of any long-term side effects from the treatment. The~     collection of long-term effectiveness data on subjects treated with Prolieve® will provide~     information on the long-term effects of treatment and time to re- treatment (any treatment~     initiated for BPH since Prolieve' treatment, including a second treatment with Prolieve).~   "
118152|NCT02021019|"~     Sympathetic activation is a hallmark of end-stage renal disease and adversely affects~     cardiovascular prognosis. Hypertension is present in the vast majority of these patients and~     plays a key role in the progressive deterioration of renal function and in the exceedingly~     high rate of cardiovascular events. Selective catheter-based renal denervation has been shown~     to be safe and effective in attaining improved and sustained blood pressure control in~     patients with resistant hypertension and normal renal function. The investigators hypothesize~     that catheter-based renal denervation is a safe and effective intervention to achieve~     sustained reduction in sympathetic nerve activity, BP and target organ damage in hypertensive~     End-Stage Renal Disease (ESRD) patients, which will result in improved cardiovascular~     outcomes.~   "
118153|NCT02021006|"~     The exact role of urinary tract infection in the appearance of chronic kidney disease is~     unclear. Children with congenital malformations of kidney and urinary tract have the higher~     risk of impairment of renal function. To understand if the use of antibiotic prophylaxis can~     reduce the risk of urinary tract infection in children with these malformations, this study~     will randomize children in two groups. Group A will not take antibiotic prophylaxis, Group B~     will take antibiotic prophylaxis for 2 years. This study will assess if antibiotic~     prophylaxis reduce the risk of urinary tract infections in these children and if urinary~     tract infections influence the appearance of renal damage.~      Our hypothesis is that prophylaxis reduce the risk of infection in severe vesicoureteral~     reflux and that urinary tract infections, in morphologically normal kidneys, will not result~     in chronic renal failure.~   "
118154|NCT02020993|"~     There is a need for a biochemical marker in addition to clinical condition which will help~     the physician to understand the clinical progress of the disease.~      Urine Nt-proBNP, which does not need any blood sampling and can be collected easily, has not~     been evaluated for respiratory distress in newborn.~      The investigators aim to evaluate the prognostic value of urine NT-proBNP in respiratory~     diseases in newborns by a controlled trial.~   "
118155|NCT02020980|"~     The objective of this study is to demonstrate the effect of intramuscular BoNT-A injections~     in relieving pain, in a broad population of patients who suffer pain as the primary problem~     associated with spasticity. Thus, this study will help to expand the information that is~     available regarding the impact of BoNT-A treatment in routine clinical practice conditions.~      Treatment goals can vary greatly from one patient to another and there is no unique, single~     outcome that reflects the treatment benefits in all the cases. Therefore, this study with~     special focus on the achievement of therapeutic goals, will allow the identification of each~     patient's specific goals regarding the improvement of the functional outcomes, the quality of~     life and patient well-being.~   "
118156|NCT02020967|"~     The primary objective of the protocol is to define percentage of patients with acromegaly in~     relation to the total number of screened patients with confirmed clinically significant set~     of associated somatic disorders with the help of laboratory (Insulin-like Growth Factor I,~     Growth Hormone, Oral Glucose-Tolerance Test [IGF-1, GH, OGTT]) and instrumental examination~     methods (Magnetic Resonance Imaging [MRI]).~   "
118157|NCT02020954|"~     The purpose of this study is to determine whether electrocardiogram, echocardiography,~     cardiac MRI, sera biomarkers can improve early detection of myocardial involvement and~     clinical outcome.~   "
118162|NCT02020889|"~     The purpose of this randomized, double-blind study is to investigate the efficacy and safety~     of mepolizumab (300 milligram [mg] administered subcutaneously [SC] every 4 weeks) compared~     with placebo over a 52-week study treatment period in subjects with relapsing or refractory~     Eosinophilic Granulomatosis with Polyangiitis (EGPA) receiving standard of care therapy~     including background corticosteroid therapy with or without immunosuppressive therapy. During~     the treatment period, in accordance with standard of care, corticosteroid dose will be~     tapered. The key outcomes in the study focus on evaluation of clinical remission, defined as~     Birmingham Vasculitis Activity Score (BVAS)=0 with a corticosteroid dose of <=4 mg/day~     prednisolone/prednisone, reduction in disease relapse and reduction in corticosteroid~     requirement.~   "
118163|NCT02020876|"~     This clinical utility study pilot is based on a review of real but de-identified and~     randomized patient cases and aims to evaluate Urologists' treatment recommendations before~     and after reviewing the results provided by the Decipher test. This is a pilot study and the~     primary intent is to help guide development and design of future clinical utility studies for~     Decipher~   "
118164|NCT02020863|"~     The purpose of this study is to evaluate the feasibility of a closed-loop (automated) fluid~     administration system to deliver fluids using feedback from standard operating room~     hemodynamic monitors. In standard anesthesia care the rate of IV fluid administration to the~     patient is determined by the anesthesiologist caring for the patient. In this study protocol,~     the rate of fluid administration will be determined instead by the closed-loop (automated)~     control system under the supervision of the anesthesiologist. The system will independently~     decide when to give fluid and at what rate; the supervising anesthesiologist will monitor the~     system to ensure appropriate volumes are being delivered and to intervene if necessary.~   "
118165|NCT02020850|"~     The Toe-Brachial Index (TBI) that has been using in our laboratory is 0.6, but the average~     value we measured in normal individuals is about 1.0, furthermore, we can not find out the~     reference of TBI that is currently being used. The purpose of this study is to determine the~     more accurate value of TBI and Ankle-Brachial Index (ABI). In this study, all participants~     will be required to fill out a demographic questionnaire before the blood pressures test. All~     participants will have their toe, ankle and brachial systolic blood pressure measurements to~     obtain the TBI and ABI.~   "
118166|NCT02020837|"~     This study will assess the impact of lymphaticovenous microanastomosis in volume reduction of~     postmastectomy upper extremity lymphedema. We hypothesize that multiple lymphaticovenous~     micro-anastomosis in the distal arm will result in the reduction of volume and improvement in~     quality of life of patients with post-mastectomy lymphedema~   "
118167|NCT02020824|"~     Virtual reality is currently used as a therapeutic strategy in common phobia as agoraphobia~     or acrophobia, since it permits to have a better control (on occurrence of events or on the~     environment) during the therapy than in in vivo therapy. Our hypothesis here is that we can~     improves the therapeutic effects of the virtual exposure by giving control to acrophobic~     patients during their exposure.~   "
118168|NCT02020811|"~     The study will evaluate the functionality of IMMAGES , an intravenous infusion device system,~     in patients hospitalized in Bait Balev hospital. The study will aim to determine how the~     IMMAGES system integrates within IV infusion therapy regime and what are the advantages and~     disadvantages, if any, of using this system within the prescribed setting.~   "
118169|NCT02020798|"~     The purpose of this study is to assess whether food ingredient(s) affect glycemic responses.~   "
118170|NCT02020785|"~     Phosphorus-based food additives are commonly used by food manufacturers for many~     applications, such as enhancing flavor, in ready-to-eat foods and beverages. While these~     additives can significantly increase an individual's daily phosphorus intake, little is known~     about the effect of dietary phosphorus on kidney health. In this study, the investigators~     will first lower baseline phosphorus intake to about 1000mg/d by educating participants to~     avoid foods with phosphorus additives. Then, participants will be randomized to a higher~     phosphorus period (~2gm/d) and a lower phosphorus period (~1gm/d) by providing unaltered,~     commercially-available food/beverage products with and without phosphorus additives.~      The investigators hypothesize that participants will have higher urine albumin excretion and~     fibroblast growth factor-23 during the higher phosphorus period compared to the lower~     phosphorus period.~   "
118171|NCT02020772|"~     Patients who suffer from musculoskeletal pain often have more than one diagnosis. These~     patients mostly have to wait a long time for the doctor's examination and treatment, and they~     also often have a sick leave for a long period of time. The investigators expect that~     treatment and follow-up by an coordinating interdisciplinary team can improve these patients~     opportunity to function, increase their quality of life, and decrease their pain. The purpose~     of this study is to investigate if use of a coordinating interdisciplinary team in primary~     health care will result in reduced sick leave compared with practice as usual, and give fewer~     referrals to specialized health services and private rehabilitation centers. Research data~     will be obtained from the patients journals, questionnaires, and clinical examinations..~   "
118172|NCT02020759|"~     Neurological complications are frequent during extracorporeal membrane oxygenation (ECMO)~     representing a crucial factor for patient outcome. However, to date there is no consensus~     with regard to optimal neurological monitoring of patients undergoing ECMO.~      The aim of this study is to monitor patients using transcranial Doppler (TCD) ultrasound and~     near-infrared spectroscopy (NIRS) during ECMO therapy.~      The study hypothesis is that TCD and NIRS technology are sufficient tools to detect cerebral~     embolism and hypoperfusion during ECMO therapy.~   "
118208|NCT02020278|"~     The objective of this trial is to provide 6 months of safety follow-up for children and~     adolescents with dilutional (euvolemic or hypervolemic) hyponatremia who have previously~     participated in a tolvaptan hyponatremia trial, and to assess the efficacy of tolvaptan in~     increasing serum sodium for those subjects who receive optional continuing tolvaptan~     treatment of variable duration (up to 6 months).~   "
118359|NCT02018315|"~     The purpose of this trial is to determine if an alternative energy source will impact brain~     metabolism in a disorder characterized by glucose metabolism failure in the brain.~      The central hypothesis tested in this investigation is whether circumventing impaired glucose~     metabolism is feasible, safe and potentially promising by supplying anaplerotic precursors~     through metabolism of odd-carbon fatty acids that can enter the citric acid cycle (CAC)~     through alternative metabolic pathways.~   "
118173|NCT02020746|"~     The main objective of this study is to assess the safety and the efficacy of EscharEx in~     preparing the wound's bed in patients with hard to heal venous leg ulcers, diabetic lower~     extremity ulcers and traumatic/post operative wounds.~      This study will be a multi-center, assessor blinded, randomized, controlled study intended to~     demonstrate superiority of EscharEx debriding treatment over the Gel Vehicle control~     treatment in patients with hard to heal wounds.~      72 + 24 adults with >50% necrotic/slough/fibrin non-viable tissue on a hard to heal wound~     (venous leg ulcer, diabetic lower extremity ulcer or traumatic/ post operative wound) between~     5 cm2 and 200 cm2 (surface area in stage 1) or 3 cm2 - 150 cm2 (in stage 2), will be enrolled~     into the study.~      Patients will undergo a 1 week screening period (2 visits) which will include: record of~     demographics, medical history and concomitant medications, vital signs, physical examination,~     clinical laboratory tests, wound photography and assessments and questionnaires (wound status~     and quality of life). During this period wounds will be treated by standard treatment per the~     decision of the physician. During this screening period, subjects whose study wound size~     (surface area) decreases by more than 20 percent will be excluded. Following completion of~     the screening process, eligible patients will be randomized to either EscharEx or Gel vehicle~     debridement treatments. In stage 1 (72 patients): Treatment will be performed for up to 10~     applications or until complete debridement is achieved, whichever occurs first. In stage 2~     (24 patients): Treatment will be performed for up to 8 applications or until complete~     debridement is achieved, whichever occurs first. Following each application the wound will be~     washed, photographed and assessed for wound size, removal of nonviable tissue and change in~     granulation tissue (by digital planimetry software), wound status, and safety parameters.~     Subsequent to each debridement treatment the wound will be dressed with moist-to-moist saline~     gauze (except when successive 24h or 48h treatments are performed, in the second stage).~     Following completion of the debridement treatment period, patients will be treated according~     to standard procedures and evaluated (wound assessments) once a week until complete wound~     closure for up to 12 weeks from last application (up to 12 visits). Only during the first~     stage of the study, for patients who achieved wound closure, additional 3 monthly (3 visits)~     follow- up visits of wound closure recurrence will be conducted. Quality of life (QoL) will~     be evaluated at the last follow-up visit - 3 months post wound closure follow-up period. For~     patients who didn't achieve wound closure only the 3 months FU visit will be conducted. For~     patients enrolled at the second stage, if wound closure was achieved at the 12 weeks~     follow-up, additional visit will be performed 2 weeks later to confirm wound closure.~   "
118174|NCT02020733|"~     The aim of this study is to compare the metal cannula routinely used in our clinical practice~     with intrauterine hysterosalpingography catheter as a probable alternative device in a~     prospective, single-blinded, randomized study.~   "
118175|NCT02020720|"~     This pilot clinical trial studies fluorine F 18 fluorodopa (18F-DOPA)-positron emission~     tomography (PET) in planning surgery in patients with gliomas. New imaging procedures, such~     as 18F-DOPA-PET scan, may help find gliomas and may help in planning surgery.~   "
118176|NCT02020707|"~     This phase I trial studies the side effects and best dose of paclitaxel albumin-stabilized~     nanoparticle formulation and bevacizumab in treating patients with stage IV melanoma that~     cannot be removed by surgery or with cancer of the cervix, endometrium, ovary, fallopian tube~     or peritoneal cavity. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized~     nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by~     killing the cells, by stopping them from dividing, or by stopping them from spreading.~     Monoclonal antibodies, such as bevacizumab, may block tumor growth in different ways by~     targeting certain cells. Giving paclitaxel albumin-stabilized nanoparticle formulation and~     bevacizumab may kill more tumor cells.~   "
118177|NCT02020694|"~     Hypovitaminosis D is highly prevalent in the general population, particularly in obese~     individuals. Besides being associated with obesity, vitamin D deficiency seems to be involved~     in the pathogenesis of insulin resistance and low-grade chronic inflammation. In addition, it~     has been reported that individuals with low vitamin D levels are at increased risk for~     cardiovascular diseases. A healthy diet and weight loss are cornerstones in the prevention of~     cardiovascular diseases. Vitamin D supplementation could increase the beneficial effects of~     these lifestyle interventions. The purpose of this study is to assess whether vitamin D~     supplementation in conjunction with a hypocaloric diet improves the cardiometabolic profile~     of overweight/obese subjects to a greater extent than diet alone.~   "
118178|NCT02020681|"~     The purpose of this study is to evaluate the therapeutic benefit of Curodont Repair for the~     treatment of early buccal carious lesions compared to placebo.~   "
118179|NCT02020668|"~     Despite leading cause of morbidity, treatment strategies for Rheumatic diseases are geared~     almost exclusively toward medical-pharmacological area away from offering the patient the~     possibility of an interdisciplinary approach to their disease.~      Present study test whether treatment of physiotherapy reduces stiffness and pain inherent in~     rheumatic disease and improve their quality of life related to health.~   "
118180|NCT02020655|"~     Background: A pressure ulcer is localized tissue injury to the superficial layer of the skin~     and/ or the underlying tissue. Pressure ulcers are most likely to develop in skin areas~     exposed to pressure, shear and friction. Shear- force is an important contributing factor and~     wound dressing are possibly capable to reduce shear force at the skin. At this moment there's~     no good marker to detect the effect of shear- force at the skin. A potential marker could be~     cytokines (IL-1α) which are released after mechanical loading of the skin. A previous study~     have shown a significant increased level of IL-1α after the application of pressure. We want~     to investigate if these cytokines are significant increased after the application of shear-~     force at the skin.~      Objective: The objective of this study is to gather knowledge about cytokine concentrations~     (IL-1 α) in the skin of healthy volunteers after the application of shear- force. We want to~     use this knowledge in the future to investigate if different prophylactic wound dressings are~     capable to reduce shear force at the skin. This could be interesting in the prevention of~     pressure ulcers.~      Study design: With the use of a special developed shear- force model are we going to~     administer 20 Newton (2 kg) shear at the palmar side of the under arm in 10 healthy~     volunteers for 30 minutes. As a control we ware going to put the shear- force model at the~     other arm without the application of shear- force. Before the use of the shear- force model~     we will perform cytokine measurements with the use of Sebutape. Sebutape is capable to absorb~     cytokines from the skin. After the use of the shear force- model we will perform cytokine~     measurements again. Then we will extract the cytokines from the Sebutape with the use of~     ELISA.~      Study population: 10 Healthy volunteers Age 18- 30 years~      Primary outcome: IL-1 α concentration (pg/ml)~   "
118181|NCT02020642|"~     The purpose of this study is to investigate the effect of renal transplantation on fluid~     overload and its consequence on the severity of obstructive sleep apnea, in patients with end~     stage chronic kidney disease. It aims further to investigate the relationship between~     overhydration, nocturnal rostral fluid shift and the severity of sleep apnea.~   "
118182|NCT02020629|"~     In hypoglycemia, there is a counterregulation to restore glucose levels. An important part of~     this counterregulation is the release of the hormone glucagon. Since the GLP-1 receptor~     agonist lixisenatide has been shown to be associated with a low risk of hypoglycemia, this~     study examines whether lixisenatide affects the glucagon response to hypoglycemia.~   "
118183|NCT02020616|"~     The purpose of this study is to investigate the safety and effectiveness of the study drug~     known as LY3053102 in participants with Type 2 diabetes mellitus. The study drug will be~     given in different doses as an injection under the skin. The study is expected to last up to~     6 months for each participant. Participants may remain on stable-dose metformin as prescribed~     by their personal physician.~   "
118184|NCT02020603|"~     Endoscopic high-frequency soft coagulation is available for the management of bleeding or~     nonbleeding visible vessels during endoscopic submucosal dissection. However, its efficacy on~     peptic ulcer bleeding has not been elucidated so far. The aim of this study was to evaluate~     the efficacy of hemostasis with soft coagulation using hemostatic forceps by comparing it~     with argon plasma coagulation (APC) in a prospective, randomized trial.~   "
118185|NCT02020590|"~     Fracture healing is a complex physiological process caused by interaction of cellular~     elements, cytokines and signaling proteins, which results in the formation of new bone. There~     is for now no universally accepted approach to evaluate the progression of fracture healing.~     Typically, a fracture is considered as a delayed-union when the bone has not united within a~     period of time that would be considered adequate for bone healing. Delayed-union suggests~     that union is slow but will eventually occur without additional surgical or non-surgical~     intervention, whereas non-union is defined as the cessation of all reparative process of~     healing.~      The incidence of impaired healing is estimated to range from 5 to 10% of all long bone~     fractures, depending on the fracture site, the type and degree of injury, among other~     factors. Currently the treatment of choice remains bone allograft or autograft. This~     procedure shows in general good results but requires an invasive surgery of several hours~     under general anesthesia, followed by a few days of hospitalization. Because of this, major~     complications have been reported in up to 20-30% of patients.~      The present Phase 1/2a study aims at demonstrating the safety and efficacy of ALLOB®, a~     proprietary population of allogeneic osteoblastic cells, in the treatment of delayed-union~     fractures of long bones. In this study, delayed-union is defined at the time of screening as~     an absence of healing of minimum 3 months and maximum 7 months (+/- 2 weeks) after the onset~     of the fracture.~   "
118186|NCT02020577|"~     The trial is divided in two parts, Part A and Part B. Part A will involve dose-finding of~     dose-limiting toxicity (DLT) and MTD in patients with advanced solid tumours. Part B will~     involve expansion of the MTD to 3 cohorts including non-small cell lung cancer squamous~     histology, recurrent/ metastatic squamous cell carcinoma of head and neck and other advanced~     solid tumours (except sarcomas).~   "
118187|NCT02020564|"~     The purpose of this research study is to investigate the effectiveness of a technique~     designed to improve processing speed (i.e. the amount of time it takes to process~     information) in a Traumatic Brain Injury (TBI) population. The study is designed to study how~     well this technique can help people with TBI increase their processing speed and their~     ability to function better in everyday life.~   "
118188|NCT02020551|"~     Pain during intrauterine device (IUD) insertion can be a barrier to initiation. Misoprostol~     and nonsteroidal drugs have found to be ineffective by clinical trials.Investigators tested~     whether intracervical 2% lidocaine gel decreased insertion pain compared to placebo.~   "
118189|NCT02020538|"~     This primary aim of this study is to test the impact of a strategy of perioperative~     chloride-restriction through intravenous (IV) fluid therapy on the incidence of acute kidney~     injury after cardiac surgery.~      A prospective, open-label, single-centre 4-period sequential study of varying strategies of~     perioperative IV fluid composition will test the hypothesis that a perioperative protocol for~     the administration of chloride-poor intravenous fluids compared to chloride-rich intravenous~     fluids will reduce the incidence of AKI after adult cardiothoracic surgery.~   "
118190|NCT02020525|"~     -  We have previously reported the results of the primary and secondary outcomes of a~          randomized study aiming to investigate the impact of a restrictive transfusion protocol~          on the magnitude of reduction in blood transfusion in a typically mixed general surgery~          population subjected to major abdominal surgery.~        -  The main finding of that study was a reduction in red blood cell usage with the~          implementation of a restrictive transfusion regimen. This was achieved without adversely~          affecting clinical outcome in the population studied.~        -  The aim of this secondary analysis performed on a subgroup of 20 patients from the~          original study was to determine whether there are any differences in the postoperative~          immunologic response, as expressed by the production of inflammatory mediators, between~          a restrictive approach to red cell transfusion and a more liberal strategy.~   "
118191|NCT02020512|"~     This study will evaluate 0.03% bimatoprost in the treatment of primary open angle glaucoma~     and ocular hypertension.~   "
118192|NCT02020499|"~     This is a long term study to evaluate common therapeutic algorithms and possible predictive~     parameters for Somatuline Autogel treatment in patients with Acromegaly.~   "
118193|NCT02020486|"~     This study will consist of 2 phases: Pretreatment Phase and Treatment Phase. The Pretreatment~     Phase will have 2 time points: Screening and Baseline. Subjects will be admitted to the~     clinical study ward the day before starting the study drug administration (Day -1) for PK and~     safety assessments during Treatment Phase, and discharged at Day 33 (group A) and Day 47~     (group B). Post-test will be done at Day 37 (+/-1), Day 42 (+3) (group A) and Day 51 (+/-1),~     Day 56 (+3) (group B). Study medication will be administered with 240 mL of room temperature~     water~   "
118194|NCT02020473|"~     End-of- life care is a major issue in medical ethics with life support technology progress.~     Intensive care may prolong the dying process in patients who have been unresponsive to the~     treatment already provided. Withholding or withdrawing of life support (WLS) care was~     introduced to avoid the suffering of critically ill patients. Decision to WLS is a difficult~     and affected by several factors including not only disease severity but also ethics,~     religion, culture, and legal background. In western countries, advance directives had an~     important role to WLS for dying patients and honor patient autonomy. However, the illegality~     of advance directives in Korea and Korean culture under Confucianism, requiring children to~     do the best to treat their parents in the name of filial piety make physicians and family~     members difficult to WLS in terminally ill patients.~      Additionally, WLS in intensive care unit had been usually decided without official~     documentation before the final legal decision by Supreme Court in Korea. Scanty information~     exists about end-of-life practices because informed consents of WLS were taken after the~     legal decision.~      Thus, we aimed to investigate the current status of informed consent at the time of decision~     to WLS and difference between WLS group and non-WLS group in Korea.~   "
118195|NCT02020460|"~     The study will examine the feasibility of Direct Dorsal Column Stimulation using existing~     Stimulation Leads (Ad-Tech). Secondary endpoints will include pain relief, somatosensory~     evoked potentials (SSEPs), stimulator settings required, improvement in quality of life and~     use of pain medications.~   "
118196|NCT02020434|"~     RPX7009(beta-lactamase inhibitor) is being studied in combination with carbapenem (RPX2014)to~     treat bacterial infections, including those due to multi-drug resistant bacteria.~   "
118360|NCT02018302|"~     This protocol provides ongoing access to triheptanoin for patients who did complete an~     initial pilot protocol, and provides the opportunity to collect long-term safety data from~     patients treated with triheptanoin.~   "
118197|NCT02020421|"~     The current standard of care for rehabilitation of patients with aphasia after stroke is~     conventional speech and language therapy (SLT). Due to economic realities on most stroke~     units, SLT can often not be given with optimal intensity in the first weeks after the stroke.~     Developing new adjuvant therapies which may render SLT sessions more effective is thus one~     approach to improve rehabilitation outcome. Recent functional imaging studies in post-stroke~     aphasia have shown that the recruitment of brain regions in the unaffected hemisphere seems~     to be an inferior strategy for recovery of language function as compared to re-activation of~     brain regions in the vicinity of the infarct. Non-invasive brain stimulation techniques, such~     as repetitive transcranial magnetic stimulation (rTMS) or transcranial direct current~     stimulation (tDCS) are new methods to modulate brain activity. Evidence from our own~     feasibility study in sub-acute stroke suggests that these new techniques, when applied in~     conjunction with conventional SLT, may help to normalize brain activation patterns and might~     yield better rehabilitation outcome than SLT alone. With NORTHSTAR, we propose a multicenter~     proof-of-concept study to investigate the safety, feasibility and efficacy of these new~     non-invasive brain stimulation methods as adjuvant therapies for subacute post-stroke~     aphasia.~      Our goal is to determine the most effective brain stimulation modality to decrease inhibition~     onto the left side of the brain. We will assess if a combination of brain stimulation and~     speech and language therapy will improve language recovery. We will quantify language~     recovery (expressive and comprehensive skills) using specific tests, commonly used by speech~     and language therapists.~      We will invite patients recently admitted to the stroke unit of the study centers to~     participate in our research project. Once patients consent to our study we will randomly~     assign them to one of three experimental groups. For 12 days, all groups of patients will be~     setup with brain stimulation during their usual rehabilitation sessions. Two of those groups~     (treatment groups) will each receive a different type of brain stimulation (rTMS and tDCS),~     in the third group, patients will not receive real stimulation (placebo group). By comparing~     the extent of aphasia recovery between groups, we will determine the benefits attributable to~     brain stimulation relative to SLT alone.~   "
118198|NCT02020408|"~     This study will use brain imaging technologies to measure several neurotransmitters~     (serotonin and dopamine) that contribute to our abilities to respond to reward or inhibit our~     impulses, and which are known to be altered in the brain of people with anorexia nervosa (AN)~     and bulimia nervosa (BN). Because palatable food stimulates dopamine secretion, we propose to~     use a challenge with brain imaging that will stimulate dopamine release which we hypothesize~     will generate anxiety rather than pleasure in AN, and will help explain why AN restrict~     eating in order to reduce anxiety. This study will help to understand the unique puzzling~     symptoms in eating disorders and contribute to finding better methods for identifying~     effective treatments for these often relapsing and sometimes chronic disorders.~   "
118199|NCT02020395|"~     The objective of this study is to examine ghrelin, amylin, glucagon and glucagon-like peptide~     (GLP)-1 responses to a test meal in lean and obese individuals.~   "
118200|NCT02020382|"~     The purpose of this study is to assess the diagnostic value of microRNAs in IBD colon~     (ulcerative colitis or Crohn's disease) in adults as compared to healthy controls (and~     non-IBD colitis)~   "
118201|NCT02020369|"~     The purpose of the study is to assess the safety, efficacy and pharmacokinetics of 2 separate~     dose regimens (75µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for the~     treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor~     VIII/IX~   "
118202|NCT02020356|"~     The primary purpose of the protocol is to demonstrate that the use of music therapy may make~     it possible to discontinue at least one of neuroleptic treatment in patients with AD or~     related symptoms complicated by behavioral disorders such as agitation and aggressiveness~     evaluated using the Neuropsychiatric Inventory (NPI).~      The study hypothesis is that music therapy may have a positive impact on patients with AD~     complicated by behavioral disorders by reducing the intensity of oppositional behaviour and~     aggressiveness and allowing a diminution of neuroleptic treatment.~   "
118203|NCT02020343|"~     America's preferential consumption of high-fat/high-sugar foods is a driving force in the~     current epidemic of obesity and insulin resistance. Recent scientific observations suggest~     that the taste of food may play a role in how the body processes the food eaten in a meal.~     The intestine may play a central role in all aspects of dietary fat metabolism, from initial~     encounter with taste buds in the mouth to eventual triglyceride (TG) storage in the body.~      The investigators hypothesize that elevated blood fats in insulin resistance are a result of~     elevated intestinal-TG secretion and poor communication of this organ to the rest of the body~     after meals.~      In this study, meal feeding and sensory studies will be performed to determine whether the~     mechanism of taste-associated intestinal signaling leads to higher levels of blood fats after~     meals in 24 healthy, insulin resistant and type 2 diabetic subjects. Individuals will consume~     special meals the night before the tests and participate in sensory tests in the morning to~     analyze the effect of taste.~      The goal of this work is to understand how insulin resistance may cause impaired signaling~     between the taste buds and the intestine to result in an elevation in blood lipids, which~     increases the risk for other chronic diseases. This study will generate data for a future~     study to understand how diabetes treatment affects this process.~   "
118204|NCT02020330|"~     This is a randomised two arm study, comparing artemether-lumefantrine 3 days and 5 days~     treatment. Patients will be randomised in blocks of ten to one of the two treatment arms. The~     standard regimen is twice daily for three days with a delay of at least eight hours between~     the first and second doses. A single of primaquine will be given to all patients on the first~     day of treatment for gametocytocidal activity. The initial treatment will be given under~     supervision, all other subsequent doses will be given to the patient to the taken at home.~     Patients will be followed up for nine visits over forty two days.~   "
118205|NCT02020317|"~     To investigate the impact of reminders for serum potassium monitoring and of hyperkalemia~     alerts during potassium-increasing drug-drug-interactions.~   "
118206|NCT02020304|"~     The hypothesis is that a combined spinal-epidural drug at refrigerated temperature will have~     a shorter period of pain relief than that maintained at room temperature. The temperature of~     the dose of medication will be measure with an infrared thermometer immediately prior (within~     5 minutes) to administration.~   "
118207|NCT02020291|"~     The Wnt proteins belong to a family of proteins that have been demonstrated to play a role in~     the formation and dissemination of tumours. The present project focuses on the critical role~     of the Wnt-5a protein in the pathobiological processes that lead to metastatic cancer~     disease.~      WntResearch has identified a formylated 6 amino acid peptide fragment, named Foxy-5, which~     mimick the effects of Wnt-5a to impair migration of epithelial cancer cells and thereby~     acting anti-metastatic. The aim of the present clinical phase 1 trial is to establish the~     recommended dose for a clinical phase 2 study and thereby further develop Foxy-5 as a first~     in class anti-metastatic cancer drug. Foxy-5 is designed to inhibit the development of~     metastasis by reducing the motility of cancer cells and should thereby increase the survival~     rates of patients with solid malignant tumours.~   "
118211|NCT02020239|"~     The investigators goal is to optimise physical activity interventions to help previously~     inactive women improve their body shape and composition. Many people seeking to lose weight~     or improve body composition initiate an exercise programme. The most common recommendation of~     an exercise intervention for someone attempting to manage their weight, has been to~     'prescribe' the recommended 150 minutes of exercise per week (World Health Organisation),~     often using one mode of exercise. An alternative approach might be to offer a portfolio of~     activities, from which the exerciser can pick and choose, to facilitate greater amounts of~     physical activity. The problem with this is how do you account for the different intensities~     of walking, washing the car, playing badminton, cycling, jogging, etc? In this study, the~     investigators will try to overcome this barrier by allocating a number of physical activity~     points to each activity. Using this physical activity points system, participants will be~     provided with a points target that they can meet using any combination of activities.~      The investigators research aim is therefore to compare this points-based system against the~     traditional 5x30minute prescription (and sedentary control) for their ability to help~     previously inactive women to drop a dress size, increase fat burning, positively change their~     body composition and tone their tummy.~   "
118212|NCT02020226|"~     The Primary objective of this study is:~      1. To determine the cardiac safety of TH-302 in patients with advanced solid tumors~      The Secondary objectives are:~        1. To assess the pharmacokinetics (PK) of TH-302~        2. To evaluate whether there is an association between plasma exposure to TH-302 and its~          active metabolite, Br-IPM, and effects on cardiac repolarization~        3. To assess the safety and antitumor activity of TH-302 in patients with advanced solid~          tumors~   "
118213|NCT02020213|"~     Invasive Aspergillus infection (IAI) occasionally occurs in immunocompromised people. Except~     administrating empirical anti-fungal agent, using objective parameters to support the~     tentative diagnosis of an IAI in order to make the anti-fungal treatment more specifically is~     also important. At present, serum galactomannan (GM) test is the less-invasive, non-cultural,~     and time-saving examination for augmenting a diagnosis of Aspergillosis. It was suggested by~     Infectious Disease Society of America (IDSA) 2008 as a screening and monitoring tool for~     Aspergillosis , and the cut-off value was adjusted to 0.5 by USA FDA . However, in clinical~     practice, GM seems not to have good predicted value even the sensitivity and specificity are~     declaimed more than 80% . Other controversial issues include the reproducibility of GM5 and~     the effect of piperacillin-tazobactam or other antibiotics on the accuracy of GM baseline In~     this study, serum GMs are examined in two conditions, one is collected for establishing a~     baseline and the other is collected after piperacillin-tazobactam administration. We hope to~     confirm the validity of GM baseline and the effect of piperacillin-tazobactam on GM value in~     Taiwan.~   "
118214|NCT02020200|"~     The purpose of the study is to explore the effect of MPH on working memory, attention and~     decision making in adults with BD in remission or in depressed state. The results will be~     compared to findings in healthy adults and adults with ADHD. The investigators hypothesize~     that MPH will incur improved performance in all measures.~   "
118215|NCT02020187|"~     Congenital myopathies are clinical and genetic heterogeneous disorders characterized by~     skeletal muscle weakness. Most patients experience muscle weakness and fatigue throughout~     their life. However, progression of symptoms is rare. There are no specific treatments for~     congenital myopathies. Training has been shown to benefit several other muscle diseases with~     weakness, but the defect in congenital myopathies involves contractile proteins of the~     sarcomere, why the effect of training is uncertain in these conditions. The investigators~     will therefore investigate the effect cycle-ergometer training for 30 minutes, three times~     weakly, for ten weeks in 15 patients with congenital myopathy. Another 5-10 congenital~     myopathy patients, who do not train, will serve as controls for the trained patients. The~     study starts and ends with a test day, where efficacy based on VO2max, performance in~     functional tests and a questionnaire will be assessed.~   "
118216|NCT02020174|"~     The purpose of The Preeclampsia Registry is to collect and store medical and other~     information from women who have been medically diagnosed with preeclampsia or a related~     hypertensive (high blood pressure) disorder of pregnancy such as eclampsia or HELLP syndrome,~     their family members, and women who have not had preeclampsia to serve as controls.~     Information from participants will be used for medical research to try to understand why~     preeclampsia occurs, how to predict it better, and to develop experimental clinical trials of~     new treatments.~   "
118217|NCT02020161|"~     Therapeutic guidelines for treatment of patients with de novo APL to be used by every~     institution that wants to follow them. All patients who are reported may be retrospectively~     analyzed~   "
118218|NCT02020148|"~     The goal of this research study is to understand the relationship between the hormone~     oxytocin and postpartum mood. Based on previous research, the investigators hypothesize that~     lower plasma oxytocin concentration during pregnancy will predict a greater likelihood of~     postpartum depression. Second, it is expected that oxytocin concentration in the third~     trimester will show an inverse relationship with the severity of depressive symptoms at 4 - 6~     weeks postpartum.~      Potential participants in the study will be screened for eligibility during their third~     trimester of pregnancy, using a combination of questionnaires. Those who are eligible for~     participation will have one blood sample drawn at this time, and then be asked to complete a~     follow up questionnaire at 4-6 weeks postpartum to assess for depressive mood symptoms. This~     follow up questionnaire can be completed either in person or on the telephone. Anyone who is~     interested in receiving help for their mood at any point in the study will receive referrals.~   "
118219|NCT02020135|"~     PSMA ADC 2301EXT is an open-label study to further assess the anti-tumor activity as measured~     by radiographic imaging and biomarkers, safety and tolerability of Prostate Specific Membrane~     Antigen Antibody Drug Conjugate (PSMA ADC) in subjects with mCRPC. Subjects who have~     participated in the PSMA ADC 2301 study and who, in the opinion of the Principal Investigator~     are likely to benefit from continued treatment with PSMA ADC are eligible for the PSMA ADC~     2301 extension study. Subjects who are benefiting from treatment may be able to receive up to~     an additional eight to sixteen doses (every 3 weeks) of PSMA ADC.~   "
118220|NCT02020122|"~     To utilize the plasticity of the central pain pathways in order to (i) shift individuals with~     a pro-nociceptive pain modulation profile towards an anti-nociceptive one, and (ii) assess~     its relevance in minimizing pain-derived morbidity.~   "
118222|NCT02020096|"~     Ultrasound imaging, an effective tool to localize peripheral nerves, may facilitate block~     performance. It allows direct visualization of nerve structures, needle guidance in real-time~     to the target, and observation of local anesthetic diffusion. Some case series have~     demonstrated significantly faster onset time for interscalene blocks, supraclavicular blocks~     and axillary brachial plexus blocks under ultrasound than with conventional techniques.~     Ultrasound guidance also enhances the quality of popliteal sciatic nerve block at the~     popliteal fossa compared with single injection, nerve stimulator-guided block using either a~     tibial or peroneal endpoint. Despite this impressive profile, the application of the~     ultrasound for lumbar plexus blocks has not been studied extensively. It is likely that~     lumbar plexus block (LPB) combined with either a sciatic nerve block or sedation or both is~     equivalent to general anesthesia and neuraxial anesthesia for knee arthroscopy. The lumbar~     plexus block is traditionally performed using surface anatomical landmarks and nerve~     stimulation. Ultrasound imaging of the anatomy relevant for LPB is challenging because of its~     deep anatomic location and the acoustic shadow of the overlying transverse processes.~     Recently, Karmakar M.K. etc. has demonstrated that a paramedian transverse scan (PMTS) of the~     lumbar paravertebral region with the ultrasound beam being insonated through the~     intertransverse space (ITS) and directed medially toward the intervertebral foramen~     (PMTS-ITS) may overcome the problem of the acoustic shadow and allow clear visualization of~     the anatomy relevant for LPB. However, the application of a PMTS-ITS used for lumbar plexus~     blocks has not been studied extensively and its advantages are not validated in a clinical~     study. Thus, we designed this prospective, randomized, subject and assessor blinded,~     parallel-group, active-controlled study to compare a PMTS ultrasound-guided lumbar plexus~     block combined with nerve stimulation and a conventional technique on time required to~     readiness for surgery in patients undergo knee arthroscopy surgery.~   "
118223|NCT02020083|"~     The purposes of this study are to determine whether transporters expression levels and drug~     interaction between TDF and FTC could contribute to modulate the placental transfer of this~     drug or. To test this hypothesis, an ex vivo model known as the perfused ex vivo cotyledon~     model allows to reproduce the conditions of the third trimester of pregnancy~   "
118224|NCT02020070|"~     The purpose of this study is to find out what effects, good and/or bad, taking ipilimumab~     with degarelix before surgery to remove the prostate, followed by more degarelix and~     ipilimumab after the surgery, will have on prostate cancer.~      The goal of this trial is to assess the safety and efficacy of a multimodality approach~     combining hormones and immunotherapy in prostate cancer populations that are considered~     incurable and standardly treated with hormones alone, and represent clinical states prior to~     development of castration-resistant disease. There are 2 cohorts. The first will use~     ipilimumab and degarelix prior to and following radical prostatectomy in men with newly~     diagnosed, oligometastatic, castration-sensitive disease. The second cohort will include men~     who have already received definitive local therapy with radical prostatectomy but have since~     experienced biochemical and/or metastatic recurrence.~   "
118225|NCT02020057|"~     To our knowledge, there has been no information on in vivo clinical results of posterior~     cruciate-substituting arthroplasties using highly cross-linked polyethylene. We evaluated~     whether the clinical and radiographic results, incidence of post fracture of the tibial~     polyethylene insert, failure of the locking mechanism of the tibial polyethylene insert, and~     the incidence of osteolysis would be similar between posterior cruciate-substituting total~     knee prostheses using conventional and highly cross-linked polyethylene.~   "
118226|NCT02020044|"~     The purpose of this study is evaluate the outcome after posterior lamellar keratoplasty (DMEK~     and Ultra-thin DSAEK) for corneal transplantation.~   "
118227|NCT02020031|"~     The purpose of this study is to determine whether or not giving a lower dose of antibiotics~     (Vancomycin) in the area where it is needed (the knee joint) is more effective at preventing~     infection than the current standard dose which is given intravenously (IV) through a wrist~     vein.~   "
118228|NCT02020018|"~     Does a wound vac dressing prevent wound infection after heart surgery?~   "
118229|NCT02020005|"~     The primary aim of this study is to determine menthol smokers' perception, product~     preference, and pattern of use across six products including, mint-flavored nicotine gum;~     non-flavored nicotine gum; mentholated nicotine inhaler; and non-menthol nicotine inhaler.~     Participants will undergo an orientation and baseline assessment followed by a 2-week product~     sampling phase. At the end of the 2 weeks of sampling, subjects will select a product to use~     during the following 2-week smoking cessation phase. This 2-week abstinence phase is followed~     by one week of abrupt withdrawal of the product. This study design was successfully used in a~     study we conducted that examined the smokers' preference for a variety or oral tobacco~     products.~   "
118230|NCT02019992|"~     To determine the plasma levels of mtDNA in ICU department patients with and without sepsis~     and evaluate their association with severity, systemic inflammation and outcomes. Plasma from~     control, septic and severe septic patients will be collected. The level of mtDNA and systemic~     cytokine will be measured.~   "
118231|NCT02019979|"~     Metformin is thought to activate AMP-activated protein kinase (AMPK), a major sensor of~     cellular energy levels and a key enzyme limiting cellular growth during times of cellular~     stress. Once activated, this enzyme restricts anabolic processes such as protein, cholesterol~     and fatty acid synthesis and inhibits mTOR, a protein kinase responsible for unregulated~     growth. MTOR is upregulated in a variety of tumors, including NSCLC providing rationale to~     take advantage of this pathway with metformin.~   "
118232|NCT02019966|"~     Antiviral resistance remains an important issue for long-term NA therapy. For lamivudine~     (LAM), the rtM204V/I and rtL180M mutations occur in more than 70% after 5 years of therapy.~     In Korea, primarily owing to limited subsidization policy in the health insurance system,~     many patients with LMV-resistance had been treated with either rescue ADV or ETV 1.0 mg~     monotherapy, ultimately leading to the higher prevalence of MDR strain. For those patients,~     rescue therapies of combining ADV with either ETV or LAM had been tried, but frequently with~     suboptimal responses. Rescue TDF monotherapy or TDF-based combination therapy are available~     in Korea for patients who had difficult-to-treat antiviral resistance owing to prior~     treatment failures. However, which is the better has not been evaluated yet. A long-term~     efficacy and safety of TDF-based rescue therapies in real practice for those patients should~     be necessary to revise the Korean guideline for the treatment of chronic hepatitis B in near~     future.~   "
118233|NCT02019953|"~     The overall approach to the study is to assess the feasibility of recruiting African~     Americans to participate in several health-promoting programs and to compare health outcomes~     among the three interventions.~   "
118234|NCT02019940|"~     This open label study will evaluate the safety and efficacy of riluzole in patients with~     PTSD. Patients will receive riluzole 50mg twice per day orally for 12 weeks as outpatient,~     with a one month follow up at week 16.~   "
118235|NCT02019927|"~     Transcorneal Electrical Stimulation (TES) using the OkuStim® device delivers electrical~     impulses to damaged and/or diseased photoreceptor cells. This electric stimulation of the~     retina may help to preserve visual acuity and/or the visual field.~   "
118237|NCT02019901|"~     Purpose: To compare a nurse-led clinic including person-centered care and tight control with~     care as usual in patients with rheumatoid arthritis (RA) and moderate/ high disease~     activity.~      Project description: Study population: Patients with RA, 18-80 yrs old, with moderate/ high~     Disease Activity Score of 28 joints (DAS28 > 3.8) and disease duration > 2 yrs in a 6-month~     randomized controlled study with a 6 month open follow-up. Intervention group (N=60):~     Nurse-led visits every 6th week, with structured person-centered care and evaluation of~     disease activity. If disease remission is not reached, pharmacological treatment including~     both short-term (intra-articular and oral steroids) and long-term alterations (DMARDs and~     biologics) is modified according to a predefined algorithm. The control group (N=60) is~     treated according to care as usual with visits to physician every 6th month. Outcome~     measures: Primary outcome measure is change in Diseases Activity Score (DAS). Secondary~     outcomes are quality of life, self-efficacy, disability, emotional well-being, pain, fatigue,~     sleep and satisfaction.~   "
118238|NCT02019888|"~     The accurate assessment of auditory status is critical for planning treatment for Veterans~     with hearing loss to include medical and audiological management. Current physiologic tests~     of auditory function in the standard clinical audiological test battery for Veterans have~     limited sensitivity in detecting some middle-ear disorders, and do not include a direct test~     of cochlear function. Recent studies have shown promise for new wide-bandwidth (WB) tests of~     absorbance for improved sensitivity in the assessment of middle-ear function including~     acoustic reflex testing. The addition of WB tests of cochlear function included in the WB~     test battery provides an opportunity to improve audiological diagnosis of a range of hearing~     disorders in Veterans. The automation provided by the WB test battery could provide~     additional benefits in reducing the duration of the evaluation, leaving more time for~     evaluation of test findings and counseling. Results from this study may lead to the~     improvement of audiological care for Veterans with hearing loss.~   "
118239|NCT02019875|"~     The purpose of this study is to determine whether changes in the activity of the enzyme~     CYP3A4 can change the Vitamin D and bone mineral homeostasis.~   "
118240|NCT02019862|"~     Clinical and radiological 2 years results of TRJ® Hip Stem.~   "
118241|NCT02019849|"~     Twelve months follow-up of implant survival and clinical and radiological follow-up of~     Plasmafit® Cup.~   "
118242|NCT02019836|"~     Neonatal sepsis is a clinical syndrome characterized by signs and symptoms of infection with~     or without accompanying bacteremia in the first month of life which is still an important~     cause of morbidity and mortality. Vitamin D is a fat-soluble steroid hormone that primarily~     contributes to the maintenance of normal calcium homeostasis and skeletal mineralization. In~     addition to its classical role in bone metabolism, vitamin D also has immunomodulatory~     effects on immune function. Although some studies reported a link between vitamin D~     deficiency and critical illness in adults, a direct relationship has not been directly shown~     yet. However, to the best of our knowledge, no study evaluated the association between EOS~     and maternal/neonatal vitamin D levels. The objective of this prospective study is to~     determine the possible role of maternal and neonatal plasma vitamin D levels on EOS~     development in term infants. We also aim to evaluate possible effect of the severity of~     vitamin D deficiency on EOS development in the study population.~   "
118243|NCT02019823|"~     General synopsis for SMS-text Adherence Support (*StAR) Study and associated preparatory and~     pilot work~      Background: High blood pressure is an important risk factor for heart disease, stroke and~     chronic kidney disease. Clear evidence exists that for individuals with high blood pressure~     (hypertension) lowering blood pressure really reduces this risk. One of the critical factors~     in the long term control of blood pressure is the regular use of effective antihypertensive~     medications. In South Africa, poor treatment adherence (attending clinic, re-filling~     prescriptions, and regularly taking hypertension tablets) is known to be an important and~     alterable risk factor for uncontrolled high blood pressure and its complications (heart~     disease, stroke and chronic kidney disease). SMS-text messages have been shown to improve~     clinic attendance and medication adherence for some diseases (like HIV and TB) in other~     low-resource settings. It is not clear whether SMS-text messages to support treatment~     adherence have an effect on long-term blood pressure control. The acceptability,~     sustainability and scalability such technology also remains to be determined.~      Aim: To investigate if a system of SMS-text messages to support treatment adherence is more~     effective than usual care for controlling high blood-pressure.~      Objectives: The main objective is to test whether advice and support given by SMS-text,~     either by providing information (informational) or by allowing a two-way communication~     (interactive) improves control of blood pressure at one year compared to usual care.~      Additional objectives include assessing whether the interventions have an effect on,~        -  Clinic attendance~        -  Prescription refill adherence~        -  Self-reported medication adherence~        -  Hypertension related illness or death~        -  Patient empowerment~      Study design: Single centre randomized three-arm parallel group trial As it is not clear how~     best to support treatment adherence for people with hypertension we need to compare the~     different ways this might be done. Eligible patients who provide written consent will be put~     into one of three groups and then compared. The groups are selected by a computer which has~     no information about the individual (i.e. by chance). Participants in each group will get~     different types of SMS-text messages and these are compared.~      Study interventions:~        -  Enhanced usual care In addition to their usual clinical care participants will receive~          the pre-randomisation Welcome to the *StAR Study SMS-text, a Happy Birthday SMS-text~          on their date of birth and up to six additional SMS-text messages containing study~          specific information and thanking the participant for taking part in the study.~        -  Informational SMS-text messages In addition to enhanced usual care, participants~          allocated to the informational SMS-text support group will receive semi-tailored~          structured adherence-support (including clinic appointment and medication pick-up~          reminders, medication adherence support and hypertension-related education.)~        -  Interactive SMS-text messages In addition to enhanced usual care and informational~          SMS-text messages, SMS-text messages sent to participants in the interactive SMS-text~          group will contain a prompt to respond which will guide participants to additional~          SMS-text based resources.~      Outcome measures: The main outcome measure is mean blood pressure measured at one year.~     Additional outcomes include the proportion of participants with controlled blood pressure~     as well as measures of clinic attendance, prescription refill adherence, self-reported~     medication adherence, hypertension related illness or death, and patient empowerment.~   "
118244|NCT02019810|"~     Severe traumatic brain injury with increased intracranial pressure can lead to decreased~     cerebral blood flow. Low cerebral blood flow is responsible for secondary lesions, leading to~     bad prognosis. It is not yet established whether increasing cardiac output in these patients~     can lead to an increase in cerebral blood flow, although there are some arguments in favor of~     this hypothesis. The aim of this study is to demonstrate that increasing cardiac output will~     improve cerebral blood flow in patients with severe traumatic injury and high cerebral~     pressure.~   "
118245|NCT02019797|"~     This study examines pharmacological preconditioning and post conditioning of desflurane by~     comparing cardiac troponin release in patients receiving either desflurane or propofol for~     the aortic valve surgery.~   "
118246|NCT02019784|"~     Patients with cirrhosis are particularly prone to infection which is frequently a precipitant~     of hepatic encephalopathy, renal failure and circulatory collapse. Bacterial infections are~     of particular concern in patients with cirrhosis because they are poorly tolerated. Sepsis~     and associated endotoxaemia whereby bacteria produce inflammatory particles occur in~     approximately 40% of hospitalized patients with cirrhosis and is a major cause of death.~      Gut-derived and blood-borne pathogens can induce an inflammatory response within the liver~     and spleen, which are the major organs that remove bacteria and their endotoxin (such as~     lipopolysaccharide - LPS and bacterial DNA itself) from the bloodstream. Several mechanisms~     have been identified and proposed in this process which depends upon a balance between the~     barrier functions of the gut and the 'detoxifying' capacity of the liver. People with~     established liver cirrhosis have been shown to have escape of endotoxin into the bloodstream~     produced by bacteria that reside in their intestines, which becomes more permeable or~     'leaky'.~      Gut dysfunction is defined by changes in the types of bacteria within the gut and in overall~     permeability allowing bacterial products which would otherwise be contained within the gut to~     travel into the bloodstream and lymphatic system with detrimental effects elsewhere in the~     body. This passage of bacterial products is termed bacterial translocation, and it's effects~     on the liver and general immune system can be then be measured.~      It has now become recognised that certain types of white blood cells such as neutrophils and~     monocytes become dysfunctional and this predisposes to infection and may also have a more~     direct pathogenic role in hepatic encephalopathy. Thus neutrophil and monocytes may be a~     novel pharmacotherapeutic target in a condition where current therapies such as bowel~     aperients (e.g. lactulose) are inadequate. A therapeutic strategy utilising Rifaximin, a~     non-absorbable antibiotic, to modulate gut bacterial which produce ammonia, a chemical known~     to be important in the cause of hepatic encephalopathy, could potentially lower gut-derived~     systemic inflammation, endotoxaemia, infection and organ dysfunction in this population~     improving outcomes and prolonging transplant-free survival.~      We therefore plan to test if Rifaximin positively affects markers of immune dysfunction in~     patients with liver cirrhosis experiencing chronic hepatic encephalopathy after 30 days of~     treatment, as our primary research question.~      Positive results from this study would support further trials into the potential benefit of~     using Rifaximin to improve immune function, as well as reduce the recurrence of hepatic~     encephalopathy, in patients with liver cirrhosis.~   "
118247|NCT02019771|"~     Hypothesis: Men who have sex with men (MSM) are at higher risk for sexually transmitted~     diseases. Currently, free testing for sexually transmitted diseases is only being performed~     in urine samples. Investigators hypothesize that the rates of both gonorrhea and chlamydia~     will be higher when testing includes more than one anatomical site (rectum and oropharynx).~      The aim of the study is to estimate the rates of asymptomatic Chlamydia and/or Gonorrhea in~     the oropharynx, rectum and urethra (urine) of HIV infected men who have sex with men at the~     specialty care center of the University of Nebraska Medical Center and compare to the rates~     in Douglas County, using nucleic acid amplification tests.~   "
118361|NCT02018289|"~     The abdominal closure with triclosan coated suture will reduce superficial surgical site~     infection.~   "
118248|NCT02019758|"~     Purpose: To determine whether oral viscous budesonide (OVB) or fluticasone metered dose~     inhaler (MDI) most effectively treats EoE by improving histologic findings and symptoms,~     which medication provides a more durable treatment response, and whether biomarkers can~     predict treatment response.~      Participants: A total of up to 200 16-80 year old patients with a new diagnosis of~     eosinophilic esophagitis (EoE) who are referred for upper endoscopy will be consented with a~     target of 122 randomized.~      Procedures: This will be a prospective, randomized, double-blind, double-dummy, clinical~     trial comparing OVB to fluticasone MDI for treatment of EoE. This overall study design will~     generate data for all three Aims~   "
118249|NCT02019745|"~     Chronic exposure to (cigarette smoke) CS causes biological changes, including airway~     remodeling and changes in baseline gene expression profiles at the level of the epithelium.~     Our own data indicate that chronic exposure to CS suppresses the ability of epithelial cells~     to enhance antiviral gene expression in response to influenza infection and activate host~     defense responses. While there is a large body of evidence supporting the notion that~     exposure to CS causes significant changes in host defense responses, which may be linked to~     permanent changes in epithelial cells at the genomic level, it is not known whether new and~     emerging tobacco products have similar or distinct effects.~      Using live attenuated influenza virus (LAIV) inoculation in human volunteers, this study will~     compare influenza-induced responses in non-smokers (NS), cigarette smokers (CS), e-cigarette~     smokers (EC), hookah smokers (HS), and Little Cigar smokers (LCS) in vivo. This will be done~     by analyzing nasal viral titers, antiviral defense responses, inflammatory mediator~     production, and markers of immune responses for LAIV-induced responses between the different~     groups of volunteers.~   "
118250|NCT02019732|"~     This is a database study to quantify the burden of multiple mild outcomes (i.e., those that~     result in visits to a physician's office) attributable to influenza in the United States,~     stratified by age group, geographic region and influenza subtype for selected influenza~     seasons.~   "
118251|NCT02019719|"~     This study aims to characterize the relationship between dose of GSK1278863 and hemoglobin~     (Hgb) response in hemodialysis-dependent (HDD) subjects with anemia associated with chronic~     kidney disease (CKD). It is anticipated that the data generated will enable selection of the~     starting dose(s) and optimize dose adjustment regimen(s) for Phase 3 clinical trials. This~     study will consist of a screening phase of 3-9 weeks, a 4-week treatment phase and a~     follow-up visit approximately 4 weeks after completing treatment.~   "
118252|NCT02019706|"~     Between 10% and 15% of patients with endogenous hypercortisolism (Cushing syndrome) have~     ectopic (non-pituitary) production of adrenocorticotropin hormone (ACTH) that causes cortisol~     excess. In approximately 50% of these patients, the tumoral source of ACTH cannot be found~     initially despite very detailed and extensive imaging, including studies such as computed~     tomography, magnetic resonance imaging, and octreotide scan (Octreoscan) using the standard~     dose of indium-111 pentetreotide ([(111)In-DTPA-D-Phe]-pentetreotide). The sensitivity and~     specificity of structurally based imaging studies depends on anatomic alterations and the~     size of the tumor. In contrast, positron emission tomography (PET) and somatostatin ligand~     (like octreotide) imaging detect pathologic tissue based on physiologic and biochemical~     processes within the abnormal tissue. This protocol tests the ability of~     [(18)F]-L-3,4-dihydroxyphenylalanine ((18)F-DOPA) PET, Octreoscan and another somatostatin~     imaging analogue, (68)Ga-DOTATATE-PET, to localize the source of ectopic ACTH production. The~     study also examines whether administration of the glucocorticoid antagonist mifepristone can~     improve the sensitivity of the (68)Ga-DOTATATE PET/CT.~   "
118253|NCT02019693|"~     Background:~        -  Papillary RCC is the second most common histologic subtype of kidney cancer, accounting~          for approximately 10-15% of cases~        -  Type 1 papillary RCC occurs in both sporadic and hereditary forms, which are~          histologically identical. Non familial type 1 papillary RCC can present as both solitary~          renal tumors and as bilateral, multifocal disease~        -  There are no standard agents of proven efficacy for patients with advanced papillary~      RCC.~        -  Patients with disease localized to the kidney are managed surgically while patients with~          advanced/unresectable disease are usually managed in the community with VEGF pathway~          antagonists or mTOR inhibitors.~        -  Activating mutations of MET were identified in the germline of affected HPRC patients,~          who have a predilection for the development of bilateral, multifocal type 1 papillary~          RCC. Somatic MET mutations have been found in a subset of patients with non-inherited,~          sporadic papillary renal carcinoma~        -  The investigational agent INC280 is a selective MET inhibitor lacking activity against~          the VEGF pathway~        -  This is a proof-of-concept study using INC280 in patients with papillary RCC to test the~          idea that effectively blocking the HGF/MET pathway will lead to clinical activity in~          patients with papillary renal cell cancer~      Objectives:~      Primary Objective:~      -To determine the overall response rate (RECIST 1.1) in patients with papillary renal cell~     carcinoma treated with single agent INC280~      Eligibility:~        -  Diagnosis of hereditary papillary renal carcinoma (HPRC) or sporadic papillary renal~          cell carcinoma (RCC)~             -  Patients with bilateral multifocal disease can have tumors localized to the kidney~               or have metastatic disease~             -  Patients with sporadic papillary RCC (but without multifocal disease) should have~               advanced disease that is considered unresectable~        -  ECOG 0-2~        -  Measurable disease~        -  Adequate organ function~        -  No active brain metastases~        -  Prior therapy~             -  No more than 3 prior lines of systemic therapy~             -  Prior therapy with a MET inhibitor is allowed as long as the patient has not had~               progressive disease while receiving the agent~      Design:~        -  This is a phase 2 single center non-randomized trial.~        -  The study will be conducted using a Simon 2 stage minimax design. Initially 13 evaluable~          subjects will be recruited. If there are no responses to therapy, the study will be~          terminated. If there is at least 1 response an additional 7 evaluable subjects will be~          accrued.~        -  The two-stage minimax design is based on assuming an ineffective response rate of 5% and~          a targeted effective response rate of 25%. We also assume that the probability of~          accepting an ineffective treatment and the probability of rejecting an effective~          treatment are each 10%.~        -  Subjects will be dosed orally at a starting dose of 600 mg twice daily.~        -  The overall response rate (complete response + partial response) will be determined.~   "
118254|NCT02019680|"~     Background:~      - Heart disease is the leading cause of death in the United States. Eating fruits and~     vegetables with chemicals called flavonoids may protect against heart disease and improve~     blood flow to the heart. They are found in blackcurrant berries. Oils found in fish and~     mussels called omega-3 fats have also been shown to protect the heart. Researchers want to~     know if blackcurrant extract and omega-3 fats can improve blood flow, which may increase~     blood to the heart. They also want to learn about the health of blood vessels and how the~     heart works.~      Objective:~      - To learn if blackcurrant extract and omega-3 fats will improve blood flow and make the~     heart beat stronger.~      Eligibility:~      - Healthy adults 55 to 75 years old.~      Design:~        -  Participants will be screened with medical history, physical exam, and blood tests.~        -  Visit 1 will take 6 7 hours.~        -  Participants will have physical exam and blood and urine tests.~        -  A small device like a microphone will be placed on their arm to take pictures of blood~          vessels. A blood pressure cuff will be tightened on their arm and more pictures will be~          taken.~        -  Blood pressure cuffs will be placed on their arms and legs. They will be tightened at~          the same time and blood pressure will be measured.~        -  Participants will answer questions about their eating and exercise.~        -  Every 8 weeks, participants switch from taking blackcurrant and/or omega-3 tablets to a~          placebo to no tablets. <TAB>~        -  Every 8 weeks, they will have another shorter clinic visit that will repeat most of~          visit 1.~   "
118255|NCT02019667|"~     Objective:~      To perform a clinical trial assessing the safety, tolerability and efficacy of the GABA(B)~     receptor antagonist SGS-742 in patients with SSADH deficiency.~      Study Population:~      Twenty-two children and adults with SSADH deficiency.~      Design:~      Double-blind, cross-over, phase II clinical trial. SGS-742 is a GABA (B) receptor antagonist~     that has shown to be safe and well-tolerated in clinical trials in adults with cognitive~     impairment. In addition, preliminary data in the SSADH knockout mouse model suggest efficacy~     in this specific syndrome. The primary outcome measure will be a change in the Auditory~     Comprehension subtest of the Neuropsychological Assessment Battery Language Module score; the~     secondary outcome measure will be a change in cortical excitation and inhibition measured by~     transcranial magnetic stimulation (TMS). Additional evaluations will include neurological and~     neuropsychological examinations, magnetic resonance spectroscopy and CSF collection to~     measure GABA levels. The trial will have a baseline phase in which each patient will undergo~     a neurological examination and a neuropsychological evaluation. During the subsequent~     treatment phase, patients will be randomized to SGS-742, supplied by IRIX Pharmaceuticals,~     and based on weight given a maximum tolerated dose not to exceed 600 mg t.i.d. orally, or~     placebo, each for 6 months. Patients will then have repeat TMS, neurological and~     neuropsychological evaluations, followed by cross-over to the alternate treatment arm, and~     re-evaluation after 6 months.~      Outcome Measures:~      The primary outcome measures for drug efficacy will be performance on neuropsychological~     testing and responses to parent questionnaire. The secondary outcome measure will be TMS~     parameters of cortical excitation and inhibition. The outcome measures for safety will~     include clinical examination and neuropsychological tests.~   "
118256|NCT02019654|"~     Objective: A traumatic brain injury (TBI) places individuals at high risk for developing~     posttraumatic stress disorder (PTSD). TBIs account for the onset of PTSD in approximately~     700,000 Americans each year. Depression and post-concussive syndrome (PCS) are also common~     and often comorbid with PTSD. However, even in this group, there is a high-level of~     inter-individual response to traumatic brain injuries, suggesting that a better understanding~     of the mechanisms underlying this risk would be of great value in directing preventive~     interventions. The reasons for this heterogeneity are undoubtedly multi-factorial, and~     involve a complex interplay between genetic and environmental factors, that we may be able to~     understand through peripheral biomarkers and central examination of neuronal functioning. We~     suggest that DNA methylation may be a putative biomarker of psychiatric risk, as it reflects~     long-term changes in the function of the gene and may shape the recovery ability of the TBI~     patient through changes in cell function. In addition, differential proteomic response,~     including the function of the neuroendocrine system, likely relates to changes from~     epigenetic modification in both neurons and immune cells, which may contribute to the risk~     for the onset of PTSD as well as depression and PCS. We have previously shown that both PTSD~     and depression are associated with endocrine alterations, leading us to question if this~     biological change may underlie vulnerability for the onset of PTSD as well as depression and~     PCS following a TBI. In support of the idea of shared vulnerability, patients with a TBI also~     often display endocrine function alterations. In addition, sleep disturbance is common~     following TBI and is a core symptom of PTSD depression and PCS, suggesting that sleep may~     contribute to psychiatric and neurological recovery from a TBI. This line of research is~     essential, as current treatments to prevent or treat psychiatric risk following TBI are often~     ineffective, and even treatment of PCS is limited. This poor understanding results in our~     limited ability to reduce the risk for compromises in the health and well-being of patients~     who sustain a TBI.~      Study population: Participants with a moderate or mild TBI (n=100) will be followed for a~     period of one year.~      Design: This is a natural history study that will recruit patients within 30 days of a~     mild/moderate TBI, and will follow them over a one year period, with follow-up at 1, 3, 6 and~     12 months following the TBI. Biological profiles including the concentration of inflammatory~     proteins and neuropeptides, and DNA methylation will be examined. An optional structural and~     functional magnetic resonance imaging (fMRI), and a hydrocortisone stimulation test will be~     used to evaluate the role of neuronal and neuroendocrine functioning following TBI.~      Outcome measures: The primary outcomes of interest are the biological changes that occur~     following TBI which are associated with the onset of psychiatric disorders of PTSD, and~     depression, as well as the onset of PCS. The secondary aim is to examine neuronal mechanisms~     that underlie the risks for these disorders through the use of fMRI. Additional aims will~     determine the role of psychological resilience traits in recovery and also how sleep relates~     to recovery and psychiatric risk.~   "
118257|NCT02019641|"~     Interstitial lung disease (ILD) is the result of over 200 etiological pathways arising from~     several different insults to the lung parenchyma: inhaled substances, drug side effects,~     connective tissue disease, infection, and malignancy. The disease can also be of idiopathic~     origin. If prolonged, the resulting inflammation causes permanent and progressive fibrotic~     reorganization of the parenchyma and small airways, which reduces the distensibility of the~     lung and impedes O2 and CO2 exchange.~      This study is a randomized controlled trial to determine the safety and efficacy of aerobic~     exercise for patients who have interstitial lung disease (ILD) uncomplicated by pulmonary~     hypertension. In an uncontrolled study, we observed more efficient cardiorespiratory~     function, increased physical work capacity, and improved health-related quality of life~     following aerobic exercise in this study population. Serious adverse events resulting from~     aerobic exercise training were not observed and our work to date has established plausibility~     for the efficacy of aerobic exercise training and its safety for patients with ILD.~   "
118258|NCT02019628|"~     The present study investigated the effect of RBAC on natural killer cell activity (NKCA) and~     the production of cytokines and growth factors over 4 weeks among healthy adults.~   "
118259|NCT02019615|"~     In this study researchers will apply transcranial direct current stimulation (tDCS) for 5~     consecutive days in chronic patients in minimally conscious state (MCS).~      2 sessions of 5 days of stimulation will be realized, one anodal and one sham. After each~     stimulation, behavioral improvement will be assessed with the Coma Recovery Scale Revised~     (CRS-R). A final assessment will be done one week after the end of the sessions to assess the~     long term effect of the tDCS.~   "
118260|NCT02019602|"~     The primary purpose is to assess whether there is transfer of Certolizumab Pegol (CZP) from~     pregnant women receiving treatment with Cimzia® across the placenta to infants by evaluating~     the concentration of CZP in the plasma of infants at birth.~   "
118261|NCT02019589|"~     This study will be a Phase 3, randomized, three-cycle, double-blind, placebo-controlled,~     parallel group, multiple-dose design.~      The study design has four phases: Screening Period; Open-Label Estrogen-Priming Period~     (Run-In Period); Blinded Treatment Period; and Follow-Up. The Open Label Priming Period and~     Blinded Treatment Period cover a total of three 28-day cycles. Clinical evaluations will be~     performed at the following time points:~      Screening Period:~      • Screening Period (approximately 42 Days)~      Open-Label Estrogen Priming Period (Run In Period):~        -  Visit 1 Baseline (Cycle 1, Day 1)~        -  Telephone Interview (Cycle 1, Day 28 [- 3 d to ±1d])~      Blinded Treatment Period:~        -  Visit 2 Randomization (Cycle 2, Day 12 [±2d])~        -  Visit 3 Interim (Cycle 3, Day 12 [±2d])~        -  Visit 4 End of treatment (Cycle 3, Day 24 [±1d])~      Follow-Up Period:~        -  Visit 5 Follow-Up (Approximately 10 days after the last treatment)~        -  Telephone Interview (Approximately 2-4 weeks after completion of progestin course) (Only~          applies to subjects receiving an approved progestin therapy for proliferative~          endometrium, as determined by biopsy.)~   "
118262|NCT02019576|"~     Stereotactic radiotherapy (SRT) is a newer type of focused radiation therapy that precisely~     and accurately delivers high dose radiation to a tumour, while sparing much of the nearby~     normal organs. The use of stereotactic radiotherapy results in high rates of tumour~     destruction with minimal side effects which are very well tolerated. Often stereotactic~     radiotherapy has been used to try to cure patients who have an early stage cancer which has~     not spread, but there is less experience with using it in patients with cancer which has~     spread.~      The purpose of this study is to measure how well stereotactic radiotherapy can destroy kidney~     cancer tumours which are no longer being controlled by Sunitinib and to measure how much~     longer such an approach will allow patients to stay on Sunitinib before needing to switch to~     another medication. Stereotactic radiotherapy will be used to treat only the growing tumours~     and then patients will continue with Sunitinib.~   "
118263|NCT02019563|"~     To compare radiographic and clinical outcomes and survival of mineral trioxide~     aggregate/ferric sulfate (MTA/FS) pulpotomy and root canal therapy (RCT) in carious vital~     primary maxillary incisors.~   "
118264|NCT02019550|"~     This is a Phase 4, prospective, open-label, randomized, cross-over, multicenter trial to~     evaluate ease-of-use with Rebif® Rebidose® and Rebiject II® autoinjectors in subjects with~     relapsing remitting multiple sclerosis (RRMS). Subjects will participate in the study for up~     to 10 weeks (including screening and treatment periods). The treatment period will last 8~     weeks and include 12 self-injections using the Rebif® Rebidose® device and 12 self-injections~     using the Rebiject II® device.~   "
118265|NCT02019537|"~     The purpose of this study is to investigate the efficacy of allogeneic PRP in patients with~     subacromial impingement disease~   "
118266|NCT02019524|"~     This is a single-center, randomized, single-blinded, three-arm phase Ib study of the folate~     binding protein vaccines E39 and J65. The study target population are patients with breast or~     ovarian cancer diagnosis who have been treated and are without evidence of disease.~     Disease-free subjects after standard of care multi-modality therapy will be screened and HLA~     typed. E39 and J65 are cytotoxic T-lymphocyte-eliciting peptide vaccines that are restricted~     to HLA-A2+ patients (approximately 50% of the U.S. population).~   "
136988|NCT01774175|"~     The investigators will compare with PEG+ascorbic acid and picosulfate+magnesium citrate about~     bowel preparation, patient's satisfaction, side effects to identify effectiveness of new~     bowel preparation drug.~   "
118267|NCT02019511|"~     It has been shown that a single high dose of steroid before surgery may reduce pain the first~     48 hours after insertion of a new joint in the knee, a so called total knee arthroplasty~     (TKA). Consequently, this has been introduced as standard treatment of most patients at~     several Danish orthopedic departments. Although there are some concerns about the possibility~     of increased risk of prosthesis infections, this has not been proved in previous studies.~     However the studies are few, have limited number of patients and are not done using a~     standardized perioperative set-up.~      This study is made to monitor the safety of a single high dose steroid injection before TKA,~     with regards to prosthesis infection within one year of surgery.~      We hypothesize that there will be no increase in infections in patients receiving steroid~     injection before TKA compared to a historical cohort of patents who did not receive a steroid~     injection before their TKA.~   "
118268|NCT02019498|"~     The aim of the pragmatic randomized study is to evaluate whether additional relaxation~     technique is more effective in the reduction of chronic low back pain compared to usual care~     alone.~   "
118269|NCT02019485|"~     The purpose of this study is to evaluate bioequivalence (biological equivalence of two~     formulations of a study medication) of a new tapentadol Extended release (ER) 100 mg~     tamper-resistant formulation (TRF) tablet, to the current tapentadol ER 100 mg,~     prolonged-release formulation 2 (PR2) tablet used in healthy participants under fasted~     (without food) conditions.~   "
118270|NCT02019472|"~     The primary objective is to investigate the efficacy of sirukumab monotherapy compared with~     adalimumab monotherapy in biologic naïve subjects with active rheumatoid arthritis who are~     intolerant to methotrexate, who are considered inappropriate for treatment with methotrexate~     or who are inadequate responders to methotrexate.~   "
118271|NCT02019459|"~     Smokers with serious mental illness including those with schizophrenia and bipolar disorder~     infrequently attempt and attain sustained smoking abstinence and have a 25-year shorter~     lifespan due to smoking-related illness. This study will examine whether reducing the~     nicotine content of cigarettes to non-addicting levels is a viable method of reducing smoking~     in smokers with serious mental illness. Smokers will be randomized to one of two experimental~     conditions: 1) very low nicotine content (VLNC) cigarettes or 2) normal nicotine content~     (NNC) cigarettes. Participants will be assessed for patterns of tobacco use, biomarkers of~     exposure, subjective responses (e.g., satisfaction, craving, withdrawal symptoms),~     psychiatric symptoms, cognitive performance, smoking cue reactivity and smoking topography.~   "
118272|NCT02019446|"~     Fungal infections of the toe affect one in three people with diabetes. Current treatments for~     fungal toe infections include oral medications, but these drugs often interact with other~     common medications. We are studying a new treatment for fungal toe infections involving the~     use of a laser device. We will compare to the standard treatment which is a type of~     antifungal medication. This laser has been tested in small numbers of patients with minimal~     side effects. There will be 60 participants selected for our study, of which 30 will receive~     standard treatment and the rest will receive laser treatment.~   "
118273|NCT02019433|"~     Implant Survival as well as clinical and radiological Follow-Up of acetabular Titan-Augment~     Structan®~   "
118274|NCT02019420|"~     This is a 1:1 ratio, randomized, double-blind, double-dummy, multicenter, global Phase 3~     study of tedizolid phosphate (TR-701 FA) 200 mg intravenous (IV) once daily for 7 days versus~     linezolid (Zyvox®, Zyvoxid®, etc) 600 mg IV every 12 hours for 10 days for the treatment of~     ventilated participants with presumed gram-positive hospital-acquired bacterial pneumonia~     (HABP) or ventilator-associated bacterial pneumonia (VABP). Participants with concurrent~     gram-positive bacteremia are to receive 14 days of active therapy in either treatment arm.~      Approximately 300 sites will participate. Ventilated participants with HABP/VABP caused by~     presumed gram-positive pathogen(s) at baseline, as determined by positive Gram stain, will be~     randomized 1:1 to study drug treatment.~   "
118275|NCT02019407|"~     Prospective Randomized Study on Clinical Effectiveness of Carvo-Tricuspid Isthmus (CTI) Block~     in Patients with Paroxysmal Atrial Fibrillation (PAF) will be performed. Study will be~     composed with two arms including 4 pulmonary vein isolation and pulmonary vein isolation with~     CTI block. After that all patients will be followed up by HRS(Heart Rhythm Society) 2010~     expert consensus guideline.~   "
118276|NCT02019394|"~     To determine the absolute bioavailability of the Lu AE58054 tablet formulation at steady~     state~   "
118277|NCT02019381|"~     Recently two distinguished committees, Institute of Medicine (IOM) and The Endocrine Society~     have proposed different intake guidelines for Calcium and Vitamin D. We wish to compare the~     effects of both of them on calcium metabolism and bone turnover. We propose a one year~     randomized double blinded study for the same.~   "
118278|NCT02019368|"~     This is a randomized, double-blind, placebo controlled, crossover study to determine the~     antioxidant effect of aged garlic extract. This study will also compare the oxidative status~     in heavy smokers with that in non-smokers.~   "
118279|NCT02019355|"~     The main purpose of this study is to determine the effectiveness of a new combination therapy~     for actinic keratosis. This study investigates a new indication for an FDA-approved topical~     medication, calcipotriol, for treatment of actinic keratosis, including how well it works and~     how safe it is when used in combination with the standard of care medication (5-fluorouracil)~     for the skin condition.~   "
118280|NCT02019342|"~     The purpose of this study is to determine~        1. whether intraoperative hypotension or hypertension is independently associated with~          postoperative mortality and morbidity~        2. whether quality improvement interventions implemented at the University of Michigan and~          at Washington University:~             1. decrease the extent and duration of intraoperative hypotension and hypertension.~             2. are associated with decreased postoperative mortality and morbidity.~   "
118281|NCT02019329|"~     This randomized, double-blinded, placebo-controlled study will investigate the safety,~     tolerability, and pharmacokinetics of multiple doses of RO5545965 administered orally to~     psychiatrically stable patients with schizophrenia receiving risperidone.~   "
118381|NCT02018029|"~     Cardiac resynchronization therapy (CRT) is one of the lastest recommended treatments in~     patients with refractory symptomatic chronic heart failure with reduced ejection fraction~     (HFREF). Despite clear guidelines 20 to 40 % of implanted patients are not clinically~     ameliorated. They are called the non responders. Patient selection seams to be one of the~     key to improve the efficiency of CRT. This protocol try to assess positive predictive factors~     to CRT by a multimodal approach.~   "
118282|NCT02019316|"~     BioSteel Sports Drink (BSD), a proprietary blend of branched chain amino acids, taurine, and~     B vitamins, has increased its popularity among professional and amateur athletes. BioSteel~     claims that BSD attenuates muscular and mental fatigue, and enhances recovery when consumed~     before and during intense exercise. To date, the efficacy of BSD on attenuating muscular and~     mental fatigue, and enhancing recovery during repeated bouts of intense exercise is unknown.~     In a blind crossover study, participants will be subjected to sprint interval exercise~     followed by muscular and cognitive function testing under two conditions: BSD and~     isoenergetic control.~   "
118283|NCT02019303|"~     To compare accuracy of ultrasound guided fine needle aspiration (FNA) to core needle biopsy~     (CNB) of ultrasound detected abnormal axillary lymph nodes in patients with newly diagnosed~     invasive breast cancer or suspected invasive breast cancer.~      Hypothesis: FNA and CNB have equivalent diagnostic accuracies~      In order to prove our hypothesis, we will perform FNA and CNB on the same lymph node in each~     consented patient. The two samples will be evaluated separately by different pathologists~     blinded to the material in the other sample.~      The results of the biopsies will be compared to the gold standard (lymph node excision).~   "
118284|NCT02019290|"~     This will be a single-center, open-label, inpatient/outpatient, fixed-sequence study~     examining the effect of multiple doses of bitopertin on single doses of Midazolam in healthy~     volunteers.~      A single oral dose on Midazolam (7.5 mg) will be administered on Day 1 after an overnight~     fast. Daily oral doses of bitopertin will be given under fed conditions from Days 2-13 and~     after fasting on Day 14. Oral doses of bitopertin and Midazolam (7.5 mg) will be~     co-administered on Day 15, after an overnight fast.~      Pharmacokinetics will be assessed throughout. Total time on treatment is expected to be 15~     days.~   "
118285|NCT02019277|"~     This open-label, multicenter, phase IIIb study will assess the safety, tolerability and~     efficacy of a combination therapy of intravenous (IV) pertuzumab (Perjeta), subcutaneous (SC)~     trastuzumab (Herceptin), and taxane chemotherapy (docetaxel, paclitaxel or nab-paclitaxel) as~     first-line therapy in participants with HER2-positive metastatic breast cancer (mBC). All~     participants will be treated with 3-week cycles of pertuzumab IV (840 milligrams [mg] first~     dose; subsequent doses of 420 mg) and trastuzumab SC (600 milligrams per 5 milliliter [mg/5~     mL]). The taxane treatment regimen will be determined by the investigator. Participants will~     continue therapy until disease progression, unacceptable toxicity, or the participant~     withdraws consent, whichever occurs first. Time on study treatment is up to 2 years.~   "
118286|NCT02019264|"~     This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study in~     overweight and obese subjects with CV disease and/or multiple CV risk factors.~   "
118287|NCT02019251|"~     The goal of this study is to evaluate the utilization of conventional 'thermally' polarized~     perfluorinated gases mixed with oxygen as inhaled inert contrast agents to image the airway~     spaces in subjects who have undergone single or double lung transplantation. This is an open~     label study expanding on current work here at Duke. Images will be obtained using 19F MRI~     during wash-in and washout for evaluation of ventilation efficiency.~   "
118288|NCT02019238|"~     Pulmonary vein isolation (PVI) combined with empiric ablation of either common sites of~     non-PV triggers of Atrial Fibrillation (AF) and locations that may sustain stable AF sources~     should be more efficacious than PVI combined with ablation of only documented non-PV triggers~     of AF in achieving long-term arrhythmia control in patients with persistent or long standing~     persistent AF.~   "
118289|NCT02019225|"~     The purpose of the TiME Trial is to determine whether dialysis facility implementation of a~     minimum hemodialysis session duration of 4.25 hours (versus usual care) for patients with~     end-stage renal disease initiating treatment with thrice weekly maintenance hemodialysis has~     benefits on mortality, hospitalizations and health-related quality of life.~      The trial also aims to demonstrate the capacity to conduct a large, pragmatic clinical trial~     in partnership with two large dialysis provider organizations.~   "
118290|NCT02019212|"~     The purpose of this study is to evaluate the quality and prognostic ability of low dose~     99mTc-tetrofosmin Myocardial Perfusion SPECT Imaging.~   "
118291|NCT02019199|"~     This study is a research initiative established to explore the use of magnetic resonance~     imaging (MRI) as a tool for detecting organ motion as it pertains to planning radiation~     therapy.~   "
118292|NCT02019186|"~     The endothelium is the lining of the blood vessels that helps prevent damage to the vessels.~     The endothelium does not function as well as it should in adolescents with type 1 diabetes.~     This causes future diabetes complications. Adolescents with diabetes also have abnormalities~     of the cells that repair the endothelium. These abnormalities may be due to damage caused by~     intermittent hyperglycemia. This studied is designed to study whether low dose, combined~     Vitamin C and E supplementation improves endothelial function and repair in adolescents with~     type 1 diabetes.~   "
118293|NCT02019173|"~     The purpose of this study is to determine~        1. if it is practical to treat moderately to severely brain injured patients who have~          problems with their balance and mobility in a group boot camp (3 days a week, 6~          hours/day for 4 weeks) exercise class.~        2. If they show improvements compared to 4 weeks of not receiving this treatment~        3. If electronic daily monitoring of their center of foot pressure during a standardized~          balance task will allow us to see small changes in ability.~      A baseline assessment of all outcome measures will be performed. This will be repeated 4~     weeks later. The intervention will be delivered (4 weeks) and a follow up assessment of all~     outcome measures will be performed one week later. A follow up of the Primary outcome~     measure, the PART-O participation questionnaire will be done 12 weeks later.~      Participants will attend group therapy consisting of a variety of exercises designed~     specifically to target balance and mobility deficits and based on the concept that through~     Repetitive Functional Task Practice (RFTP), recovery of function can occur as the result of~     neural adaptation. Exercises will be both individualized (delivered in a circuit) and group~     activities. Supervision and guidance will be provided by a registered Physical Therapist and~     a Rehabilitation Assistant. During the intervention, the amount and type of RFTP, any adverse~     events, and any need for extra staff will be recorded on a daily basis. As well, a~     standardized individualized task will be performed with center of foot pressure recording on~     a daily basis.~      Analysis: changes in outcome measures immediately after the non-intervention compared to the~     after the intervention period will be statistically determined to estimate efficacy of this~     treatment model. Descriptive measures of RFTP time/day, staffing levels/day and adverse~     events will be used to support feasibility and safety of this model.~   "
118421|NCT02017509|"~     This is an observational study of tumor samples and MRI imaging in patients with colorectal,~     melanoma, breast, renal cell, lung, bladder, head and neck, ovarian and thyroid cancers. A~     tumor sample, MRI scans, and treatment outcome data will be used for research purposes to see~     if it is possible to predict patients' response to treatment.~   "
118422|NCT02017496|"~     The study explores the safety of breast conserving treatment (BCT)(defined as complete~     removal of tumor deposits) after neoadjuvant treatment for locally advanced breast cancer.~   "
118294|NCT02019160|"~     -  Aim: This randomised controlled trial will systematically compare the efficacy of a 25%~          AgNO3 solution followed by 5% NaF varnish with that of a 38% SDF solution in arresting~          caries teeth among preschool children when applied at half-yearly intervals over a~          30-month period.~        -  Method: The extension of the Consolidated Standards of Reporting Trials 2010 Statement~          will be followed for this 30-month, randomised, double-blinded, non-inferiority clinical~          trial. Approximately 2,400 kindergarten children will be screened and at least 826~          children with caries will be recruited. This sample size is sufficient for an~          appropriate statistical analysis (power at 90% [β=0.10] with a 2-sided type-I error of~          α=0.05), allowing for a 18% drop-out rate. The children will be randomly allocated into~          2 groups to treat their caries over a 30-month period: Group A - biannual application of~          a 25% AgNO3 solution followed by a 5% NaF varnish, and Group B - biannual application of~          a 38% SDF solution followed by a placebo varnish.Clinical examinations will be conducted~          at 6-month intervals to assess whether the caries are arrested. Information on~          confounding factors such as oral hygiene habits will be collected through a parental~          questionnaire.~        -  Possible results and implications: As the first of its kind, this study would help to~          determine whether AgNO3 followed by NaF is at least as effective as SDF in arresting~          childhood caries. If so, because 25% AgNO3 and 5% NaF contain less silver and fluoride,~          respectively, than 38% SDF, their use would be more favourable than SDF in young~          children.~   "
118295|NCT02019147|"~     Despite recent advances in the care of mothers and newborn infants, many infants~     (approximately 20 per 1000 live births) continue to need resuscitation at birth. A proportion~     of these infants will have sustained significant injury through interruption of their blood~     and oxygen supply prior to delivery (perinatal asphyxia). In 2-3 babies per 1000 this will~     lead to brain swelling and the risk of long term brain injury called neonatal~     hypoxic-ischaemic encephalopathy (HIE). HIE remains a cause of neonatal death and long term~     disability. Early and accurate prediction of outcome would allow us to intervene during the~     window of the first 6 hours following birth, prior to secondary reperfusion and secondary~     brain injury. Estimating severity of injury can be difficult in newborn infants. Condition at~     birth does not predict neonatal, or longer term outcome. Biomarkers which could be measured~     at the time of birth and analysed at the bedside would offer these infants the best chance of~     timely and effective intervention. Through the BIHIVE study we have identified a number of~     predictive biomarkers in hypoxic-ischaemic encephalopathy. These markers are present in~     umbilical cord blood and have been identified through proteomic and metabolomic analysis of a~     stored biobank of samples from a recruited cohort of infants with perinatal asphyxia and~     hypoxic-ischaemic encephalopathy. We now wish to validate these biomarkers in an additional~     cohort, and will continue to explore new biomarkers in our stored biobank of umbilical cord~     samples. In addition we wish to assess our ability to predict neurodevelopmental and~     behavioural outcome in these infants. In this way we will determine the most robust~     biochemical and clinical markers for the prediction of early and medium term outcome in HIE.~     This study will establish the evidence base and validation of these biomarkers to the point~     where they can be developed into a bedside diagnostic algorithm which can be used in the~     labour ward to immediately identify those infants at risk of HIE in time to prevent secondary~     damage.~   "
118296|NCT02019134|"~     The aim of the pragmatic randomized study is to evaluate whether additional relaxation~     technique is more effective in the reduction of chronic neck pain compared to usual care~     alone.~   "
118297|NCT02019121|"~     Investigators aim to retrospectively research patients undergoing renal transplants that~     received dexmedetomidine perioperatively to see if dexmedetomidine use protects renal~     function. Investigators hope to elucidate any association between renal transplant patients~     and perioperative dexmedetomidine administration, these include (but are not limited to) UOP,~     Cr/GFR, morbidity, mortality, in hospital complications and failure rate. Investigators will~     research both living and cadaveric renal transplants.~   "
118298|NCT02019108|"~     Knee osteoarthritis (OA) is a costly health condition affecting more than 10% of Canadian~     adults. Excessive and unbalanced loads passing through the knee joint have been implicated in~     the progression of OA. Typical conservative treatment of OA has focused on increasing daily~     activity, without consideration for the underlying joint loading. This study aims to compare~     a 4-month walking program that aims to increase the angle of the foot (toe-out angle) during~     walking - a measure shown to reduce joint loading and OA disease progression - while~     increasing walking time/distance, with a standard walking program that aims to increase~     walking time/distance. It is predicted that the walking program focusing on increasing~     toe-out will provide greater reductions in self-reported knee pain and a greater reduction in~     unfavorable knee joint loading.~   "
118299|NCT02019095|"~     In a recent experimental study, the investigators showed that the growth factor Activin A is~     expressed in the lungs of rats with the acute respiratory distress syndrome (ARDS) at levels~     that are comparable with those determined in the bronchoalveolar (BAL) lavage fluid from~     patients with ARDS. In the same study, the administration of the Activin A inhibitor~     Folistatin resulted in attenuation of the histological damage of the ARDS-afflicted rat lung.~      The precise role of Activin A/Folistatin in acute respiratory failure associated with acute~     lung inflammatory pathology has not been elucidated yet. Therefore, the purpose of the~     present, observational study is to investigate the role of Activin A/Folistatin in~     respiratory failure due to ARDS and/or ventilator-associated pneumonia (VAP), also in~     relation with other biochemical markers, such as cytokines and surfactant-related proteins.~   "
118300|NCT02019082|"~     This study aimed to investigate the effect of low intensity cathodal direct current on the~     release of plasma vascular endothelial growth factor (VEGF) and nitric oxide (NO) in diabetic~     foot ulceration.~   "
118301|NCT02019069|"~     This phase II clinical trial studies how well liposomal cytarabine-daunorubicin CPX-351~     (CPX-351) works in treating patients with relapsed or refractory acute myeloid leukemia or~     myelodysplastic syndrome. Drugs used in chemotherapy, such as liposomal~     cytarabine-daunorubicin CPX-35, work in different ways to stop the growth of cancer cells,~     either by killing the cells or by stopping them from dividing.~   "
118302|NCT02019056|"~     The Purpose of A Multicenter, Randomized, Double-blind, Placebo-controlled to Evaluate the~     Efficacy, Safety and Pharmacokinetics of MG in Patients With alcoholic Fatty Liver Disease~     and Alcoholic Hepatitis.~   "
118303|NCT02019043|"~     This study aims to enhance syphilis testing among HIV-positive men who have sex with men~     (MSM), so that more men will undergo testing, they will test more often, and more cases will~     be treated early. The intervention will combine syphilis tests with the standard HIV blood~     tests that are routinely done every 3-6 months for persons in care at hospital-based HIV~     clinics in Toronto and Ottawa, Canada.~   "
118304|NCT02019030|"~     The purpose of this observational study is to evaluate the outcomes of using the PlasmaButton~     electrode in the treatment on Benign Prostatic Hyperplasia (BPH) while on anticoagulation~     medication.~   "
118305|NCT02019017|"~     Cluster headache is an intense and powerful, one-sided headache accompanied by involuntary~     symptoms such as red eye, droopy eyelids, flow of tears, small pupils and one-sided facial~     sweating. The headache is believed to be the most intense of all headaches and among many is~     totally disabling and of great personal and social consequences. For a small group of~     patients with episodic and most chronic form, drug therapy has little effect. For them,~     surgery can be a solution.~      Neuroradiology has found evidence of a possible original activation of cluster headache from~     the portion of the brain called hypothalamus. Furthermore, an activation of the~     parasympathetic nervous system through the sphenopalatine ganglion, which may also explain~     some of the one-sided involuntary symptoms, is suspected in cluster headache. Injection of~     Botulinum toxin type A (BTA) inhibits secretion of synaptic acetylcholine resulting in nerve~     signals being blocked. The duration of such a blockade is believed to be 3-9 months.~      The purpose of the present study is to develop and evaluate a new surgical procedure with~     injection of BTA for blocking of the sphenopalatine ganglion. The goal is to relieve the~     symptoms of refractory cluster headache with a minimal invasive procedure.~      The main objective of the project is to determine the safety of BTA injection in the area of~     the sphenopalatine ganglion of refractory cluster headache and detect the adverse events.~     Secondary objectives are to identify the changes of headache attacks by the method used.~   "
118306|NCT02019004|"~     The purpose of this study is to compare the effectiveness of Botox® (Onabotulinum Toxin A)~     versus Xeomin® (incobotulinum toxin A) for the treatment of forehead and glabellar (vertical~     lines between the eyebrows) wrinkles.~   "
118307|NCT02018991|"~     The polymers releasing the drug of first-generation drug-eluting stents (DES) may induce~     allergic reactions and inflammation, resulting in late-acquired stent malaposition (LASM)~     with uncoverage of struts, and risk of stent thrombosis. The incidence and predictors of LASM~     in DES with newer-generation polymers designed to improve biocompatibility are unknown.~   "
118308|NCT02018978|"~     This is a 3-year Phase II trial of a HIV prevention strategy designed to significantly reduce~     population-level HIV incidence. The study design is a two-arm community randomized controlled~     trial of Comprehensive Triaged HIV Prevention (CTHP) which includes: (a) Access to an HIV~     center which will provide free HIV testing and counseling, (b) Educational activities related~     to HIV risk behavior, (c) Special counseling sessions for HIV-infected clients, (d) A onetime~     provision of a small amount of food or health products for sex partners of persons testing~     positive for HIV or reporting HIV risk behaviors when they come to receive HIV testing, (e) A~     post test support club for persons infected with HIV, (f) An income generation training~     program for people testing positive for HIV, (g) Transportation assistance in visiting the~     HIV Care and Treatment Clinic in the area for those who test positive for HIV, and, (h)~     Counseling and transportation support for those on medical treatment for HIV to assist them~     in attending scheduled appointments, and receiving and taking their medications as~     recommended by the clinic staff. The study will take place within two communities located in~     Kisarawe district, Tanzania. The intervention will occur over an 18-month period with~     outcomes assessed at baseline and post-intervention. The study hypothesis is that individuals~     in the intervention community will have a lower incidence of sexually transmitted infections~     (STIs) than those in the control community.~   "
118309|NCT02018965|"~     There are a number of powerful anti-HIV drugs, which keep the virus at undetectable levels~     and enable HIV-infected individuals to live longer. However, some participants taking~     anti-HIV drugs do not achieve an adequate CD4 recovery and remain at risk for developing AIDS~     and non-AIDS-related complications.~      ER niacin (PrNiaspanFCT®) is an extended-released form of niacin, also known as vitamin B3.~     Niacin is effective in reducing cholesterol levels in the blood. This drug has been known for~     a long-time to treat dyslipidemia and it is used to improve favourably all the lipoprotein~     risk factors for artherosclerotic disease, particularly in HIV-infected patients. Recent~     scientific research shows that regular consumption of niacin-rich foods may also provide~     protection against Alzheimer's disease and age-related cognitive decline.~      The purpose of this study is to find out:~        1. If ER niacin combined with anti-HIV drugs, compared with anti-HIV drugs alone, could~          reduce T cell immune activation and enhance CD4 recovery;~        2. If ER niacin can improve your quality of life and your neurocognitive functions~   "
118310|NCT02018952|"~     The aim of this trial is to study the interest of ultrasonography among patients with septic~     arthritis.~      Currently, ultrasonography is useful for detecting small fluid effusions, for examining~     otherwise inaccessible joints, such as the hip and for helping the joint aspiration.~      Accurate assessment of disease activity and joint damage in septic arthritis is important for~     monitoring treatment efficiency and for prediction of the outcome of the disease.~      Nowadays, magnetic resonance imaging (MRI) provides better resolution than radiography or~     tomography for the detection of joint effusion and for differentiation between bone and soft~     tissue infectious. The sensibility is reported to be nearly 100% with a specificity of more~     than 75%.~      However, MRI is expensive and not rapidly accessible.~      Therefore, ultrasonography, a non invasive, painless, inexpensive, and non radiating exam can~     be used to assess the presence and extent of inflammation, destruction, and tissue response.~      The objective is to describe, using ultrasonography, the abnormalities joint structure~     influenced the septic arthritis evolution and prognosis.~      The investigators hope, at the end of this study, to evaluate ultrasonography interest in~     septic arthritis and to establish ultrasonography prognosis factors to predict treatment~     efficiency and functional outcome.~   "
118311|NCT02018939|"~     The study is conducted to investigate the pharmacokinetics of Doripenem during CVVHDF~     (Continuous venovenous hemodiafiltration), MARS (Molecular Adsorbent Recirculating System)~     and intermittent hemodialysis.~   "
118312|NCT02018926|"~     Mocetinostat is an orally administered histone deacetylase (HDAC) inhibitor. Azacitidine is a~     hypomethylating agent (HMA) used to treat MDS. In this study, patients with intermediate- or~     high-risk MDS will receive treatment with mocetinostat and azacitidine to evaluate the safety~     of the study treatment. Safety assessments will include echocardiograms, electrocardiograms~     and routine safety laboratory studies (hematology and serum chemistry). In addition, clinical~     response to treatment will be monitored using bone marrow aspirates or biopsies, and other~     routine methods.~   "
126993|NCT01905202|"~     Secretrol administered over a 6 month period to patients with Barrett's Esophagus will be~     safe and well tolerated. Further, pH control will be evaluated in the distal esophageal~     mucosa and just below the squamocolumnar junction.~   "
118313|NCT02018913|"~     Alzheimer's disease (AD) and vascular dementia (VaD) are the most common forms of dementia.~     Yet, the cause of these diseases is still unknown. A potentially important initiating factor~     is a disrupted blood-brain barrier. This can initiate cerebral microangiopathy, which has~     frequently been associated with VaD. Nevertheless, also in most AD patients a substantial~     increase of vascular damage has been observed. The present study investigates the correlation~     between blood-brain-barrier breakdown and cognitive decline in AD and VaD. An innovative~     dynamic contrast-enhanced MRI scan that has recently been developed and tested at our~     institute, will be used to measure blood-brain barrier permeability.~      Objective: We will investigate the relationship between this permeability measure and (i)~     cognitive performance and (ii) the status of MRI visible cerebrovascular pathology (i.e.~     white matter hyperintensities, lacunar infarctions, microbleeds) in the most common forms of~     dementia.~   "
118314|NCT02018900|"~     In the present pilot study, the investigators will study the effects of a novel synbiotic,~     which is a mix of probiotics (Ecologic 825) in the presence of a prebiotic (short chain~     fructo-oligosaccharide (scFOS)), on mucosal integrity, overall microbiota changes along the~     gastrointestinal-tract and the mucosal immune response. The investigators hypothesize that~     the synbiotic Ecologic 825/scFOS will significantly affect the intestinal permeability and~     modulate the immune system in humans.~   "
118315|NCT02018887|"~     The purpose of this study is to evaluate how safe LY2969822 (study drug) is and whether it~     causes any side effects. The study will also measure how much of the study drug gets into the~     blood stream and how long it takes the body to get rid of the study drug. This is the first~     time that this study drug is being given to participants. This study is for research purposes~     only and is not intended to treat any medical condition.~   "
118316|NCT02018874|"~     In the First-in-Human, JWAA trial, the LY2780301 displayed a favourable safety profile, a~     high pharmacokinetic exposure and the ability to decrease pS6. LY2780301 has shown~     synergistic activity in combination with targeted agents or chemotherapy including~     gemcitabine. We propose herein to combine LY2780301 with gemcitabine and to treat different~     tumor types with molecular alterations. This may validate the anti-tumor activity of the~     LY2780301 and it will increase our knowledge regarding molecular predictors of its efficacy.~   "
118317|NCT02018861|"~     Open-label, dose-escalation study in subjects with previously treated B-cell malignancies to~     find maximum tolerated dose (MTD) or pharmacologic active dose of a PI3Kδ inhibitor,~     INCB050465, as monotherapy and in combination with: itacitinib (INCB039110), a JAK1~     inhibitor; rituximab; and rituximab, ifosfamide, carboplatin, and etoposide. INCB050465~     inhibits PI3Kδ, a protein involved in growth and survival of B-cell cancer cells.~   "
118318|NCT02018848|"~     The goal of this study is to investigate an attention training program for participants with~     Obsessive-Compulsive Disorder. The attention training consists of a modified dot probe task~     with picture stimuli related to washing and checking paired with neutral pictures.~      Participants are randomly assigned to an experimental and a placebo-control group. After a~     minimum of 4 weeks of attention training we expect to find differences between participants~     of the experimental and the control group in terms of attention bias, OCD symptoms, anxiety~     and depression.~   "
118319|NCT02018835|"~     Detecting abnormalities in the left ventricular mechanical and hemodynamic response to the~     stress of exercise may offer early diagnostic indicators in patients suffering from valvular~     disease such as mitral regurgitation. Ultrasound-based imaging methods have been gaining~     importance in providing prognosis among those patients. However, decreased signal to noise~     ratio in the images and increased motion-related artifacts during exercise stress~     echocardiography have been reported, with a lack of reproducibility of results and a the~     limitation of its availability only in reference centers. In our laboratory, we are able to~     perform supine bicycle exercise MRI (1.5 T) using the Lode ergometer mounted on the far end~     of the patient table, previously described in healthy volunteers.~      The first aim of our study is to demonstrate the safety and the feasibility of our MRI~     protocol in selected patients with asymptomatic severe organic mitral regurgitation, to~     assess left ventricular volumes and function, and regurgitant volume in comparison to~     exercise cardiac echography.~      Besides, few recent studies sustain the relevance of novel markers of central aortic function~     (compliance, distensibility and pulse wave velocity) assessed by noninvasive MRI to explore~     vascular aging. In monogenic connective tissue diseases, altered arterial stiffness is the~     premature signature of the disease in asymptomatic patients. Noninvasive evaluation of aortic~     stiffness would be useful for risk assessment and preventive follow-up strategies in young~     asymptomatic relatives of subjects with aortic inherited diseases, such as syndromic and~     non-syndromic familial forms of thoracic aortic aneurysm and /or dissection. Furthermore,~     this technique should be able to evaluate the effect of drugs on aortic stiffness change in~     trials, before and after drug therapy, more relevant than the classic change in aortic~     diameter measurement.~      The second aim of our study is 1) to provide the sensibility of our MRI protocol to estimate~     local and regional heterogeneity in aortic functional parameters (distensibility, compliance~     and PWV) 2) to evaluate the predictive value of these regional aortic parameters assessed by~     MRI to diagnose and to stratify the aortopathy related to presymptomatic Marfan patients and~     to bicuspid aortic valve in young adults, in comparison to carotids-femoral pulse wave~     velocity estimation by applanation tonometry.~   "
118320|NCT02018822|"~     This double blind randomized controlled prospective clinical trial will compare the clinical~     success of two tooth colored resin composite dental filling materials - TPH3 (Dentsply Caulk)~     and an experimental urethane dimethacrylate resin based composite resin (Dentsply Caulk) for~     wear resistance, staining and marginal seal using modified Ryge criteria to evaluate the~     posterior restorations for 24 months in duration~   "
118321|NCT02018809|"~     To assess the effectiveness of reporting statin adherence patterns to a Medication Adherence~     Partner (MAP) in improving the outcome of statin adherence versus usual care as measured by~     an electronic pill bottle.~      Hypothesis: Subjects with a MAP receiving daily adherence feedback will have the highest~     statin adherence of any arm, as measured by pill bottle data.~   "
118322|NCT02018796|"~     The study will be conducted in 4 sites and will examine how a simplified outpatient medical~     abortion procedure using mifepristone and misoprostol, with the option to take mifepristone~     at a place of woman's choosing, works in Kazakhstan. The investigators intend to demonstrate~     the efficacy of oral administration of 200 mg mifepristone and sublingual administration of~     600 µg misoprostol with gestations through 70 days, as well as the acceptability of this~     method. Research questions include:~        1. What is the efficacy of regimen of 200 mg mifepristone, followed 24 to 48 hours later by~          600 µg sublingual misoprostol and used in gestations of up to 70 days?~        2. Is medical abortion procedure consisting of two visits acceptable to women in~          Kazakhstan?~        3. Are the side effects associated with sublingual use of misoprostol acceptable to women?~        4. When given a choice, do women prefer to take mifepristone in the clinic or at a place of~          their choosing?~   "
127077|NCT01904084|"~     The purpose of this study is to evaluate function, pain and radiographic evaluation in~     patients treated with volar locked plating versus Hoffman II bridging external fixation in~     patients with extraarticular distal radius fractures, AO/OTA type A~   "
118323|NCT02018783|"~     The aim of this study was to evaluate the efficacy of three desensitizing toothpastes for~     immediate and intermediate-term relief of CDH, when compared with a control toothpaste. One~     hundred and thirty-eight hypersensitive teeth were diagnosed and randomized into four groups~     according to the therapeutic agent of each desensitizing cream tested: 1) strontium acetate~     and calcium carbonate, 2) calcium carbonate and arginine 8%, 3) calcium phosphate~     nanoparticles and 4) a control toothpaste. The desensitizing creams were applied according to~     the manufacturer's instructions. Cervical dentin hypersensitivity was assessed at baseline,~     immediately, 24 hours and 30 days after the treatment. Cold and evaporative tests were used~     to assess the sensitivity level.~   "
118324|NCT02018770|"~     The present study aims to evaluate the effect of phototherapy with the combination of~     different sources of light on pain, activity of temporal and masseter muscles, bilateral and~     joint mobility in subjects with TMD. It will be made a randomized, placebo-controlled and~     double-blind clinical trial. Individuals participate with myogenic temporomandibular~     disorder, being allocated into 4 groups randomly and stratified by the method of sealed~     envelopes. The results will be evaluated using: RDC/TMD, digital caliper, electromyography,~     and visual analog scale and algometry. The protocols will be used in a single session and~     will be evaluated in four different moments. The variables that will be investigated are~     pain, muscle activity and joint mobility. The analyses of the data will be performed by~     adopting a significance level of 5%.~   "
118325|NCT02018757|"~     The purpose of the study is to determine whether transarterial chemoembolization containing~     arsenic trioxide is safe and effective in the treatment of intermediate-stage hepatocellular~     carcinoma.~   "
118326|NCT02018744|"~     This registry has been designed as a multicenter, single arm, open label, post-market~     registry study with consecutive, eligible patient enrollment at each site. All subjects~     undergoing the Endovascular Aneurysm Sealing System (EVAS) with the Nellix®-System. Subjects~     will be followed up to discharge discharge, and as per institutional standard of care~     thereafter through to 5 years (total follow-up commitment). This registry of the Nellix~     System, which has received the market authorization of the European Union (Conformité~     Européenne, CE-certification) in a real world patient population treated in a multicenter~     setting will provide an assessment of the generalizability of the approach and System.~      Up to 300 patients diagnosed with abdominal aortic aneurysm (AAA) who are considered~     candidates for Endovascular Repair, in up to 30 international centers will be enrolled in the~     study.~   "
118327|NCT02018731|"~     The purpose of the study is to compare the effects of L-citrulline and metformin and their~     combination therapy on muscle function and force in patients with Becker muscular dystrophy~     (BMD).~   "
118328|NCT02018718|"~     The aim of this study is to demonstrate and quantify the micro architecture and micro~     vascular changes within skeletal muscles after marathon using 3T MRI (diffusion tensor and~     arterial spin labeling). Apparent diffusion coefficient, fractional anisotropy and flow~     parameters will be registered before and after the long-distance run on the lower leg. Axial~     T1 and axial SPAIR sequences will also be applied at the same time.Stress ox and inflammatory~     markers will be collected in blood and urine samples and compare with both MRI and~     Near-infrared spectroscopy (NIRS).~   "
118329|NCT02018705|"~     For the treatment of Achalasia, LHM has been the only surgical therapy. Recently, an~     endoscopic approach for this therapy has been developed (peroral endoscopic Myotomy POEM).~     Studies show promising short and mid term results for POEM. At present, POEM is considered a~     promising new technique with the potential to become a standard achalasia treatment. For this~     to happen, long-term comparative data with LHM is required. Therefore,the intention for this~     study is to investigate the short and long-term efficacy of POEM for the treatment of~     achalasia as it was performed in international centers and compare outcomes with database~     assessment of LHM.~   "
118330|NCT02018692|"~     The aim of this study is to determine whether 9-cis-beta Caroten rich D. Brdawiil extract is~     effective in the treatment of retinitis pigmentosa in adolescent patients.~   "
118331|NCT02018679|"~     Topical photodynamic therapy with methyl-aminolaevulinate (MAL-PDT) has been introduced as an~     alternatively attractive procedure for BCC. Er:YAG ablative fractional laser (AFL) treatment~     removes the stratum corneum to increase MAL uptake and may improve efficacy. However, no~     studies have directly compared the efficacy of Er:YAG AFL-PDT and MAL-PDT in treating nodular~     BCC in Asians.~   "
118332|NCT02018666|"~     This is a multicenter, prospective, randomized, open-label study which compared two~     ventilation modes: spontaneous NAVA mode and spontaneous breathing with IPS mode (the latter~     is considered as the reference ventilatory mode) in patients admitted to the ICU for acute~     respiratory failure and ventilated with an endotracheal tube. NAVA mode allows to minimize~     patient-ventilator disharmony with acceptable tolerance and to preserve spontaneous~     ventilation.~   "
118333|NCT02018653|"~     The goal of this clinical research study is to learn if calcium alumina-silicate (CASAD) can~     help to stop your diarrhea. Researchers also want to know if this drug can help decrease the~     duration of your diarrhea.~      In this study, CASAD will be compared to a placebo. A placebo is not a drug. It looks like~     the study drug but it is not designed to treat any disease or illness. It is designed in this~     study to be compared with the study drug to learn if the study drug has any real effect.~   "
118334|NCT02018640|"~     Use of tobacco is very high among Alaska Native pregnant women. The investigators are~     conducting a three phase study. The first study is nearly completed and involved measuring~     biomarkers of tobacco exposure in mothers and infants. The second phase of the research is a~     qualitative study to translate the biomarker findings to an intervention.~   "
118335|NCT02018627|"~     This study will test the hypothesis that micro-doses of Xerisol Glucagon (Xeris~     Pharmaceuticals) will be non-inferior by pharmacokinetic and pharmacodynamic criteria vs.~     micro-doses of Glucagon for Injection (Eli Lilly).~   "
118423|NCT02017483|"~     Lots of studies suggest that children with ADHD have deficits in facial emotion recognition,~     especially for the negative emotion. But there were arguments for this deficit is a secondary~     problem due to the general attention impairment in ADHD, or a specific social cognitive~     processing to ADHD. The objectives of this study are to investigate that association between~     the deficits in facial emotion recognition and the emotional attention processing in ADHD. In~     this study, the investigators use the emotion attentional bias and emotional go / no go~     paradigm to answer this question.~   "
118336|NCT02018614|"~     Acute pain is responsible for unnecessary suffering. Among elderly patients, acute pain is~     frequent and underestimated, especially when these patients have cognitive disorders. The~     expression of pain is then modified and the conventional tools for evaluating pain cannot be~     used. Thus the existence of pain must be detected on the basis of a behavioural assessment.~      It is nonetheless necessary to have the assistance of standardised and validated tools. In~     France, the Doloplus Group has proposed a scale called Doloplus, validated in January 1999,~     and is now proposing a new scale for acute pain, Algoplus that has been validated in French~     (4). Doloplus has been recently translated and validated in 5 languages and an identical~     methodology will be used in this protocol.~      Internationally, although several teams are working on the development of scales that can be~     used for non-communicating elderly subjects, there is as yet no validated tool for acute pain~     assessment.~      Considering 1- the lack of tools at an international level and 2- the frequent request from~     many practitioners worldwide, the Doloplus group has offered to validate the Algoplus® scale~     in 5 foreign languages, English, German, Spanish, Italian, Portuguese. A rigorous methodology~     with the help of a statistician will be used in this validation process.~   "
118337|NCT02018601|"~     The main objectives of the trial are the efficacy and safety of intercostal nerve block in~     the midaxillary line versus paravertebral block, both guided by ultrasound in patients~     scheduled for not reconstructive breast surgery.~   "
118338|NCT02018588|"~     Our objective is to determine the requirement for the amino acid tryptophan in school age~     children using the indicator amino acid technique.~   "
118339|NCT02018575|"~     Our objective is to determine the metabolic availability of Lysine in white maize using the~     indicator amino acid oxidation (IAAO) technique in adult men.~   "
118340|NCT02018562|"~     Verbal communication is vital to critically ill mechanically ventilated patient's quality of~     life (Hess, 2005). Patients who have a tracheostomy tube may be able to communicate using a~     speaking valve, however, some patients may not be able to tolerate cuff deflation for use of~     speaking valve. There are talking tracheostomy tubes that do not require cuff deflation to~     facilitate speech in this population. Unfortunately, not all candidates are offered these~     options due to lack of awareness. Recently, at our institution, there has been an increase in~     the use of these tubes to facilitate speech. One of the talking tracheotomy tubes that has~     proven to be effective is the Portex Blueline Ultra Suctionaid (BLUSA).~      In 2010, we conducted a retrospective review of 4 cases and found that BLUSA tracheostomy~     helped facilitate communication in this unique population (IRB #: NA_00041547). We would now~     like to formally conduct a prospective pilot study to evaluate the feasibility of measuring~     outcomes of patients with a BLUSA using a pretest-posttest research design.~      Communication empowers patients and allows healthcare staff to obtain a more accurate~     assessment of patients' condition and tailor care accordingly. Identifying the predictors of~     speech intelligibility and the impact of BLUSA on quality of life will promote communication~     between patients and healthcare providers.~      Study Hypothesis: Determine the impact of a talking tracheostomy tube on quality of life in~     patients requiring prolonged mechanical ventilation in the hospital.~   "
118341|NCT02018549|"~     Phase IIa, single center, open-label, single-arm study, to evaluate the inspiration profile~     through the NEXThaler device in adult COPD patients with varying degrees of airflow~     limitation~   "
118342|NCT02018536|"~     The purpose of the study is to investigate the safety, tolerability, and pharmacokinetic~     (what the body does to a medication) of GSK2336805 alone and with the co-administration of~     TMC435 in healthy Japanese participants.~   "
118343|NCT02018523|"~     The purpose of this study is to investigate the safety and efficacy of maintenance therapy~     with daily low dose lenalidomide in patients with stage IIIB/IV non-small cell lung cancer~     (NSCLC) after first line chemotherapy. Investigators expect this treatment approach will~     delay disease progression by boosting the patient's anti-tumor immune response. Investigators~     hypothesize that 10 mg/day of lenalidomide can be administered safely as maintenance therapy~     and improve progression free survival time.~   "
118344|NCT02018510|"~     The proposed study is a first-in-man phase I study that aims to evaluate the safety,~     tolerability and pharmacokinetics of 3BNC117 in HIV-infected and HIV-uninfected subjects, and~     its antiretroviral activity in HIV-infected subjects.~   "
118345|NCT02018497|"~     The essential arterial hypotension and allostasis registry is a prospective, observational~     research that has the purpose of demonstrating that essential blood pressure (BP) disorders~     and the associated comorbidities are a result of the inappropriate allostatic response to~     daily life stress. This required a functioning brain orchestrating the evaluation of the~     threat and choosing the response, this is a mind-mediated phenomenon. If the response is~     excessive it contributes to high BP, if deficient to low BP, and the BP itself will identify~     the allostatic pattern, which in turn will play an important role in the development of the~     comorbidities.~      To do so, consecutive patients of any age and gender that visit a cardiologist's office in~     Medellin, Colombia, are recruited. Individuals are classified according to their arterial BP~     and allostasis and follow them in time to see what kind of diseases develops the most~     (including BP) in the follow up according to the categorization of the characteristic chosen~     and after adjustment for confounder's variables. In addition, stress events with their date~     are registered.~      HYPOTHESIS~      The causes of the diseases are multifactorial.~      Physical, biochemical, psychological, social, and cultural dimensions of development~     dynamically interact to shape the health development process.~      A person´s health depends on their:~        1. Biological and physiologic systems~        2. External and internal environment (a) physical, b) internal behavioural and arousal~          state as registered by the brain.~        3. Their interaction.~      The allostatic mechanisms to the internal and external stressors (allostatic load) involves a~     network composed by:~        1. Functional systems; mediated by:~             1. The Autonomic Nervous System~             2. The endocrine system~             3. The immune system~        2. Structural changes: whenever the internal and/or external stressors are long lasting~          and/or strength enough, they may induce changes in:~             1. Epigenetic, endophenotypes, polyphenism.~             2. Plasticity~        3. The interaction between a) and b).~      The network response do not affect exclusively the BP, propitiating the development of~     comorbidities, which may prompt strategies for prevention, recognition and ultimately,~     treatment.~      The allostatic model defines health as a state of responsiveness.~      The concept of psycho-biotype: The allostasis is the result of both: biological (allostasis)~     and psychological (psychostasis) abilities. It is proposed that both components behave in~     similar direction and magnitude.~      Immune disorders may be associated with the development of cancer. High BP population has a~     higher sympathetic and lower vagal tone, this has been associated with a decrease in the~     immune´s system function.~      Resources and energy depletion: Terms like weathering have been used to describe how~     exposures to different allostatic loads gradually scrape away at the protective coating that~     keeps people healthy. It is postulated that High BP individuals have more resources and~     energy.~   "
118346|NCT02018484|"~     Unicompartmental knee replacements are performed to treat osteoarthritis or osteonecrosis of~     the knee especially when it affects only the medial femoro-tibial compartment. To place the~     prosthesis, bone removal is necessary. The orientations of the bony cuts directly influence~     the position of the different elements of the prosthesis and the limb alignment. It is known~     that good positioning of the prosthesis is the key of a good survival of the implants. To~     guide the blade of the saw, cutting guides are used. The position of these guides gives the~     final position of the cuts. At present, two main techniques are used to position the guides:~     the conventional one, not very costly but not very accurate, and the navigated procedure,~     which is more accurate but also more expensive and more invasive. Since few years, patient~     specific cutting guides are used in total knee replacement with encouraging results and more~     recently in uni compartmental knee replacement with no scientific proof of efficiency.~      This study aims to validate the procedure of patient specific cutting guides.~   "
118347|NCT02018471|"~     Diagnostic tests have a deep emotional impact on oncology patients. Anxiety and worries can~     lead people to avoid screening tests, with high risks for health. A single arm, pilot study~     was organized to evaluate the feasibility and efficacy of psychological counselling for~     cancer patients who demonstrated anxiety for diagnostic tests. The hypothesis was that taking~     part in Psychoeducative Training could offer a new modality to reduce anxiety, before and~     during tests, and also the possibility to reinforce coping strategies.~   "
118348|NCT02018458|"~     The primary objective of this study is to determine the safety and feasibility of combining~     cyclin B1/WT-1/CEF (antigen)-loaded DC vaccination with preoperative chemotherapy.~      The secondary objectives of this trial are to determine pathologic complete response rates;~     disease-free survival; to assess immune biomarkers of immunity (antigen-specific CD8+ T cell~     immunity and TH2 T cells) in breast cancer biopsy specimens and blood samples in patients~     receiving DC vaccinations; and to assess the feasibility of immunizing LA TNBC and ER+/HER2-~     BC patients with patient-specific tumor antigens.~   "
118350|NCT02018432|"~     Main adverse events of Roflumilast are weight loss, loss of appetite, insomnia, headache,~     diarrhea, vomiting, and nausea. Although the majority of these adverse reactions were mild or~     moderate. They occurred mainly at the beginning of therapy and mostly resolved with continued~     treatment around for two weeks according to experiences of clinicians. These adverse events~     occur more often in Roflumilast 500 μg than 250 μg, having negative impact on compliance of~     patients at the early stage of treatments.~      Thus, investigators aim to compare the drop-out rates between the usual dosage (Roflumilast~     500 μg once daily) and the dose escalation (Roflumilast 250 μg once daily for 4 weeks and~     then escalating dose of 500 μg once daily).~   "
118351|NCT02018419|"~     This phase I/II study is designed to compare different treatment schedules of a personalized~     anti-cancer vaccine protocol which combines the cryoablation of a selected metastatic lesion~     with intra-tumor immunotherapy. The cryoablation causes the tumor to release tumor-specific~     antigens into the surrounding environment. The injection of bioengineered allogeneic immune~     cells, AlloStim(TM), into the lesion is designed to modulate the immune response and educate~     the immune system to kill other tumor cells.~   "
118352|NCT02018406|"~     The purpose of our study is to determine the safety and efficacy of the combination of~     erythropoietin (EPO) and granulocyte-colony stimulating factors (G-CSF) in patients with~     neurological diseases. To be specific, our clinical study is expected that the combination~     injection of EPO and G-CSF shows neurotrophic and neuroprotective effects by facilitating~     endogenous repair process in patients with neurological diseases including stroke, cerebral~     palsy, or atypical parkinsonism. Therefore, we will apply our original treatment technique in~     patients with neurological diseases, which is expected to overcome current ethical and~     technical limitations of less evidenced functional recovery, hematological changes, and side~     effects. Eventually, We will establish a comprehensive clinical background about neurotrophic~     and neuroprotective effects of this hematopoietic growth factors therapy.~   "
118353|NCT02018393|"~     This study aims to evaluate the immunomodulatory effect of FEIBA® in patients with severe~     haemophilia A and inhibitors.~   "
118354|NCT02018380|"~     Osteoarthritis (OA) is a progressive, chronic disease affecting more than 20 million~     Americans. There is no known cure for OA and management includes pain control and prevention~     of functional decline.~      Purpose: To investigate the immediate effects of a shock absorbing insole (SAI) placed in the~     shoe on knee pain, functional mobility and lower extremity biomechanics.~   "
118355|NCT02018367|"~     The overall goal of the study is to determine whether imaging with the low-cost High~     Resolution Microendoscope(HRME) will increase the efficiency and yield of the current~     standard of endoscopic surveillance of Barrett's esophagus. We believe the HRME will provide~     an in-vivo optical biopsy that will be comparable to gold standard histopathology and allow~     the endoscopist to make a more informed decision about whether to obtain a biopsy or even~     perform endoscopic therapy (i.e. endoscopic mucosal resection, EMR).~   "
118356|NCT02018354|"~     The purpose of this study is to compare outcomes (failure, function, strength, range of~     motion and quality of life) between patients who receive the usual anterior cruciate ligament~     (ACL) reconstructive surgery and patients who receive anterior cruciate ligament~     reconstructive surgery with a lateral extra-articular tenodesis (extra tendon repair on the~     outside of the knee). Some studies have shown high graft failure rates (ACL re-tear) in young~     individuals who return to pivoting contact sports following ACL reconstruction. This study is~     designed to look at whether or not adding this extra tendon repair reduces the risk of graft~     failure in this population.~   "
118357|NCT02018341|"~     A randomized double-blind placebo controlled homeopathic pathogenetic trial (HPT) will be~     carried out on 30 healthy adult volunteers. The remedy used for the proving will be~     administered in a potency of 30C. The remedy being used is a common homeopathic remedy~     commercially available in the US, but the exact remedy is not disclosed to participants.The~     purpose of the proving is twofold: 1) to determine if there is a difference in symptoms~     between those receiving an active versus placebo medicine, and 2) to see if there is a~     difference in gene expression between those who receive the homeopathic remedy or placebo. It~     is hypothesized that participants receiving the active medication will have more symptoms~     characteristic of the remedy and have specific patterns of gene expression in whole blood~     that are different from those in placebo recipients. Participants will record symptoms in a~     diary for 3 days prior to administration of study medications, during 3 day of its~     administration and for 3 days following completion of the study medication. Blood will be~     drawn for gene expression studies on the day that the study medication is started and again~     after taking the study medication for approximately 48 hours. An additional, optional blood~     draw for possible future analysis of gene expression will be done at the end of the study~     period.~   "
118358|NCT02018328|"~     Background and Aims~        -  H.pylori is a common human pathogen by which almost 50% of the world population is~          infected. According to the accepted guidelines, once H.pylori infection has been~          diagnosed,first line therapy with three drugs should be given. The triple treatment~          includes proton-pump-inhibitor-clarithromycin-amoxicillin but its eradication rate is~          only 70-80%.~        -  Curcumin has many beneficial merits and it was also been demonstrated to be efficient in~          inhibition of H.pylori infection, in vitro.Therefore we aim to investigate whether~          addition of Curcumin to the standard triple therapy will increase the eradication rate~          of H.pylori infection.~      Methods~        -  150 consecutive patients that will undergo esophagogastroscopy in our Gastroenterology~          department and will be positive for H.pylori according to urease test and then by~          gastric biopsy, will be included. The patients will be randomized to two different~          treatments, according to binomial distribution. 75 patients will be treated with the~          standard triple therapy for 10 days and the other 75, will be treated for 10 days, with~          triple therapy combined with Curcumin that will be given three times a day.~        -  During the treatment the patients will complete an adverse effect's questionnaires. 6~          weeks after the completion of the treatment the patients will undergo urea breath test~          to confirm eradication. Patients will be asked to avoid antibiotics, bismuth compounds~          or proton-pump-inhibitor until the second urea-breath-test.~        -  We will compare the eradication rate and the adverse effects between the two groups by~          using SPSS~   "
137002|NCT01773993|"~     To collect the efficacy and safety information of Pregabalin on Fibromyalgia patients related~     to their appropriate use in daily practice.~   "
118362|NCT02018276|"~     Studies have attempted to control pain and increase patients' recovery satisfaction following~     many kinds of operations by using as small an opioid analgesic dose as possible and adding a~     nonopioid analgesic to reduce the side effects of narcotic analgesics. Among nonopioid~     analgesics, lidocaine and magnesium are drawing attention, having been shown to be helpful in~     controlling postoperative pain by lowering pain hypersensitivity to surgical stimuli.~     Lidocaine acts as an antagonist of the N-methyl-D-aspartate (NMDA) receptor. An~     intraoperative intravenous injection of lidocaine has been reported to improve postoperative~     pain control by reducing postoperative pain and opioid consumption. Another report showed~     that an intraoperative intravenous injection of lidocaine improved the quality of~     postoperative functional recovery after general anesthesia in a laparoscopic cholecystectomy~     patient. In addition, a review article on the effect of intraoperative intravenous injection~     of magnesium found it to be an effective analgesic that may be added to conventional~     opioid-based therapy because it generally reduces opioid consumption, decreases pain~     assessment for 24 hours after surgery, and lacks severe side effects in relation to magnesium~     administration. However, there has been insufficient research comparing the intraoperative~     intravenous injection of lidocaine or magnesium in terms of which is more helpful for general~     functional recovery and decreased postoperative pain. Recently, the scope of research on~     anesthesia has come to embrace postanesthetic recovery; to help patients return to daily~     life, the research trend is now shifting from the improvement or resolution of a specific~     symptom to the measurement of general recovery. Postoperative recovery is a complicated~     process related to such catamnestic factors as physiological end-points, the incidence of~     adverse events, and changes in psychological status. A widely used method to measure~     postoperative recovery is the Quality of Recovery 40 (QoR-40) survey. The QoR-40 includes a~     total of 40 questions that may be divided into five sub-categories: emotional state, physical~     comfort, psychological support, physical independence, and pain. The respondent answers each~     question on a 5-point scale, with one being worst and five being best. The QoR-40 takes 6.3~     minutes on average to complete and is known to have good test-retest reliability, internal~     consistency, and split-half reliability. With respect to anesthetic recovery, the QoR-40 has~     been used in various studies to investigate how the surgery type, anesthesia method,~     administration of an additional drug, and gender affect anesthesia and surgery. The validity~     of the QoR-40 for research purposes has already been established.~      Therefore, in this study, we investigated the intraoperative intravenous injection of~     lidocaine and the intravenous injection of magnesium to compare these drugs' helpfulness in~     the functional recovery of thyroidectomy patients after general anesthesia.~   "
118363|NCT02018263|"~     This study looks to explore the feasibility, sensitivity, validity, and specificity of a~     Remote Wireless Sensor Network (RWSN) approach to the detection of cocaine use/intoxication~     in the inpatient human laboratory, as well as in the outpatient setting (real world).~     Lastly, we look to design an algorithm for reliably detecting cocaine use in real-world~     settings and inference techniques for understanding the relationship between cocaine use and~     user contexts.~   "
118364|NCT02018250|"~     This clinical study will evaluate escalating dosages of MMB4 DMS to determine its safety when~     delivered intramuscularly (i.m.) to the anterior thigh.~   "
118365|NCT02018237|"~     The purpose of this research study is to learn more about how high fructose corn syrup, a~     sugar used to sweeten drinks and foods, affects metabolism in obese persons with and without~     nonalcoholic fatty liver disease. Eligible participants will be studied before and after~     eating a diet high in high fructose corn syrup or a standard diet (low in high fructose corn~     syrup) for four weeks.~   "
118366|NCT02018224|"~     The intention is to compare 60 patients with Achilles tendon rupture, who where randomized in~     1998-2001 preoperatively to receive end-to-end suturation by the Krackow locking loop~     technique either without augmentation or with one central down-turned gastrocnemius fascia~     flap (Silfverskjöld). Postoperative care was identical for both groups; A brace allowed free~     active plantar flexion of the ankle postoperatively, whereas dorsiflexion was restricted to~     neutral for the first three weeks. Weight bearing was limited for six weeks. To compare these~     treatments, we use 1998 published Leppilahti-score, Rand-36 quality of life-questionnaire and~     MRI. Mean follow-up time is 14 years.~      Hypothesis; Augmentation with a down-turned gastrocnemius fascia flap does not provide better~     result than would end-to-end suture repair with use of the Krackow locking loop surgical~     technique in long-term follow up.~   "
118367|NCT02018211|"~     Numerous techniques are reported to enhance recovery following intense exercise, however~     there is equivocal support for such claims. A novel technique of neuromuscular electrical~     stimulation (NMES) via the peroneal nerve has been shown to augment limb blood flow which~     could enhance recovery following exercise. The present study examined the effects of NMES,~     compared to graduated compression socks on muscle soreness, strength, and markers of muscle~     damage and inflammation following intense intermittent exercise.~   "
118368|NCT02018198|"~     The purpose of this study is to investigate FebriDx, a point-of-care, non-invasive, rapid~     diagnostic test, at identifying an immune response to viral and bacterial infection related~     to an acute community acquired febrile upper respiratory infection, as compared to expert~     clinical reviewers' evaluation in conjunction with the results of clinical standardized~     microbiologic and laboratory testing.~   "
118369|NCT02018185|"~     In a preliminary pilot study, the investigators tested the efficacy of rTMS over the medial~     prefrontal cortex in symptom profiles of obsessive compulsive disorder (OCD) patients. This~     study revealed considerable benefit in using rTMS for the treatment of OCD.~      In the current proposal, in a randomized clinical trial, the investigators aim to further~     evaluate the efficacy of rTMS in OCD in a larger sample size and for a longer period. Studies~     into the efficacy of rTMS in other psychiatric disorders such as depression have consistently~     shown that extension of the treatment to four weeks significantly increased the effect size.~     In the pilot study, the investigators applied rTMS for only two weeks. Although all patients~     consistently showed improvement in their symptoms, none of them showed complete remission of~     their OCD. Here, the investigators hypothesize that longer duration of rTMS treatment will~     have greater benefit in OCD symptom reduction.~   "
118370|NCT02018172|"~     The study is performed to collect long-term data on the treatment adherence and patient's~     acceptability when Zomacton®10 mg is administered with the Zomajet® Vision X device in~     patients with a growth hormone deficiency or Turner's syndrome.~   "
118371|NCT02018159|"~     This post-marketing, multi-center prospective study will be conducted in a open-label,~     non-interventional setting, for women seeking fertility treatment and will describe~     morphokinetic de-selection parameters in human embryos.~   "
118372|NCT02018146|"~     Failed mask ventilation poses an increased risk of de-oxygenation to the patient undergoing~     general anesthesia. Nasopharyngeal ventilation may be a valid alternative for mask~     ventilation allowing for better oxygenation during the induction phase of general anesthesia.~     Oxygenation may be maintained better in case of difficult mask ventilation. This study~     evaluates this alternative method in comparison with the standard method of mask ventilation.~      General Design This is a randomized, controlled, cross over study. Patients will be~     randomized to mask ventilation followed by nasopharyngeal airway placement and ventilation or~     vice versa.~      Primary Study Endpoints We will test the hypothesis that ventilation via a nasally placed ETT~     is superior in its efficacy (as measured by tidal volume) to routine facemask ventilation in~     patients undergoing general anesthesia and endotracheal intubation for their surgery.~   "
118373|NCT02018133|"~     The purpose of this study is to identify genes that are responsive to paricalcitol (active~     vitamin D) therapy. Scientists have found that over 30 different types of cells in the body~     respond to vitamin D therapy, including blood vessels. Low levels of vitamin D may reduce the~     amount of calcium in the blood, increase the amount of parathyroid hormone (PTH) and cause~     the parathyroid gland (small gland located in the neck) to get bigger which is called~     secondary hyperparathyroidism (SHPT). Also, low levels of vitamin D may worsen the heart~     disease seen in dialysis patients. Paricalcitol, a man-made active vitamin D, is a~     replacement for vitamin D for preventing and treating SHPT. Studies that followed patients on~     dialysis have found: (1) differences in death rates between those who received active vitamin~     D compared with no activated vitamin D, and (2) a survival benefit in chronic kidney disease~     (CKD) patients receiving paricalcitol, over calcitriol (natural active vitamin D).~     Researchers have considered that giving paricalcitol to people with (CKD) may also prevent or~     slow the progression of heart disease.~      Currently, physicians can only tell how well the vitamin D is working by measuring PTH~     concentrations. This study aims to identify markers in the blood that can be used to~     determine the efficacy of Vitamin D therapy.~   "
118374|NCT02018120|"~     The aim of this randomized controlled clinical study is to evaluate and compare the~     effectiveness of platelet rich fibrin (PRF) and connective tissue grafts in the treatment of~     multiple gingival recessions.~   "
118375|NCT02018107|"~     In this research study, the investigators are evaluating whether ammonia PET scans or FDG PET~     perfusion scans are more useful in helping radiologists determine whether liver tumors were~     successfully destroyed by the heating or freezing procedures (ablations) than other scans~     currently available to radiologists, such as CT scans and MRI scans.~      The currently available scan (usually a CT scan with contrast dye) is not always effective in~     showing how completely the tumor has been destroyed. The ammonia PET scan is a different way~     of looking at how much tumor has been destroyed. This study will compare the standard scan~     (CT scan) with the ammonia PET scan.~   "
118376|NCT02018094|"~     -  Lower limb amputations are performed usually as a last resort in patients with acute and~          chronic limb ischaemia (CLI) caused by vascular disease, poorly controlled diabetes or,~          infection.~        -  In the period 2003-2008 there were approximately 5,000 amputations per year in the UK.~        -  The Centre for Disease Control defines a Surgical Site Infection (SSI) as an infection~          within 30 days of an operation or up to one year if an implant is left in place and the~          infection is related to an operative procedure.~        -  Figures from the Surgical Site Infection Surveillance reported that the highest rate of~          surgical site infection was reported in association with lower limb amputation at 13.1%.~        -  There is a clear under-representation and the infection rate within our institution is~          approximately 25% which reflects the infection rate reported in a recent trial by Sadat~          et al (22.5%)~        -  Prevention of surgical site infections is of paramount importance to patients,~          healthcare providers and policy-makers, as they impact on morbidity and mortality and~          have significant time and cost implications.~        -  Currently there is NO CONSENSUS as to what the best practice is towards antibiotic~          administration in such patients. From a questionnaire-based audit we performed including~          vascular departments across the entire country, practice varies in both course duration~          (single dose → 5 days antibiotic course) as well as choice of antibiotics.~        -  The guideline at our institution suggests the 5-day course of antibiotic prophylaxis.~          The course duration varies depending on the clinical picture as well as microbiology~          results and recommendations.~        -  There are no randomised control trials that have investigated this aspect of patient~          care. We have set up one such trial and through it, we are looking to establish a~          standard practice which will hopefully be as beneficial as possible to the patient but~          also cost-effective for NHS.~   "
118377|NCT02018081|"~     The aim of this study is 1. to describe levofloxacin pharmacokinetics in ICU patients~     suffering from pneumonia with taking into account physio-pathological parameters. 2. to~     verify clinical and bacteriological efficiency and to know if the peak/Minimum Inhibitory~     Concentration (MIC) ratio > 5 and Area Under Curve (AUC) /Minimum Inhibitory~     Concentration(MIC) ratio > 125. No therapeutic drug monitoring will be performed in this~     study.~   "
118378|NCT02018068|"~     Perineural injection of local anesthesic is currently the reference method for the treatment~     of post operative pain in a patient undergoing major orthopedic surgery. Postoperative pain~     is a dynamic phenomena in every patient. It is classified as intense during the first~     postoperative hours after surgery, and decreases in a non-linear manner over the days~     following the procedure. PCA (patient control analgesia) infusion of local anesthesic allows~     an adaptation of the local analgesia doses to the evaluated pain scores, as well as permit a~     decrease in adverse events related to the continuous infusion technique (motor or sensory~     blockade, paresthesia, etc.). The physician can also modify the pump settings according to~     the postoperative rehabilitation plan.The use of new communication techniques such as~     telemedecine may be of interest in reducing treatment onset time and optimizing pain~     management. The remote control consists to change the settings of the pump after if the~     anesthesiologist was informed in real time (via a smartphone or a tablet) on patient pain~     level, sensory and motor blockades. The physician goes to a dedicated website (Micrel~     CareTM). and makes the necessary changes by remote control via a GPRS (General Packet Radio~     Service) connexion. The aim of this prospective, comparative, multicentric trial is to~     compare the effectiveness of patient management through two communication modalities: remote~     control versus bedside care.~   "
118379|NCT02018055|"~     The purpose of this study is to evaluate the efficacy and safety of clopidogrel in stabilized~     patients with acute myocardial infarction (AMI) who performed percutaneous coronary~     intervention (PCI) with drug-eluting stents (DES) compared with ticagrelor.~      In this study, 3,288 patients with AMI who underwent PCI with DES and took dual antiplatelet~     therapy as aspirin and ticagrelor during 1 month from index PCI will be randomized to aspirin~     and ticagrelor versus aspirin and clopidogrel during 11 months.~   "
118380|NCT02018042|"~     Alopecia areata (AA) is a common disease of the immune system, known as an autoimmune~     disease. In this disease, the immune system mistakenly destroys the hair follicle, causing~     hair to fall out. Despite many people having this disease, research into its cause and into~     new, better ways to treat Alopecia Areata has lagged far behind other similar diseases of the~     immune system. Currently, there are no Federal Drug Administration approved drugs for~     Alopecia Areata.~      Abatacept (made by Bristol-Myers Squibb) is a safe intervention known to effectively treat~     rheumatoid arthritis, another autoimmune disease, by fighting inflammation. There are some~     genetic and chemical similarities between those with active rheumatoid arthritis and Alopecia~     Areata, suggesting that treatment with the same drug is likely to be effective. In mice~     specially designed for testing drugs for the treatment of human alopecia, this medication~     worked to prevent the disease Alopecia Areata from starting.~      To test Abatacept, we are going to treat 15 patients with moderate to severe Alopecia Areata~     for 6 months. Each person enrolling into this study will receive the active study drug. The~     effectiveness of the medication will be measured by changes in hair re-growth as determined~     by physical exam and photography, as well as by patient and physician scoring. Patients will~     be followed for another 6 months off of the drug to see if the effects of treatment last and~     if there is delayed response. We have recently changed the study to allow testing of~     abatacept in a few patients with alopecia totalis and universalis.~      Small scalp biopsies and peripheral blood will be taken at the beginning of the study before~     treatment and then after 4,12 and 24 weeks. The chemical analysis of these skin samples and~     blood will help us to understand how the disease happens, how the treatment works, and~     perhaps even guide us to better treatments in the future.~   "
118382|NCT02018016|"~     Background~      Appendicitis is a common condition which represents a significant resource burden for the~     Scottish National Health Service (NHS). It is unknown whether there are significant~     differences in Scottish appendicectomy (appendectomy) outcomes which may be explained by~     hospital volume. In many studies, hospital procedural volume has been shown to be predictive~     of surgical outcomes.~      Aims~      The aim of this study is to compare appendicectomy outcomes in Scotland as they vary by~     hospital procedural volume.~      Methods~      This research study is a retrospective observational enquiry which will utilise~     administrative data from the Information Services Division (ISD) of NHS National Services~     Scotland. Patient episodes will be identified by a procedure codes for appendicectomy. A 10~     year period will be studied, from January 2001 to December 2010.~      Primary outcome measures will be risk-adjusted 30 day/inpatient mortality, 30 day readmission~     rate, 30 day re-operation rate, length of stay and negative appendicectomy rate.~   "
118383|NCT02018003|"~     The purpose of this study is to assess the women's quality of life, who accepted~     chemotherapy,radiotherapy, concurrent radiochemotherapy or who didn't accept therapy, after~     operation.~   "
118384|NCT02017990|"~     This study will evaluate the association between n-3 polyunsaturated fatty acids and patient~     and graft survival. The association between other fatty acids and mortality and graft loss~     endpoints will also be evaluated.~   "
118385|NCT02017977|"~     Introduction~      'Emergency Laparotomy' is an umbrella term for a set of commonly performed procedures which~     are known to carry a significant risk of mortality and morbidity. Previous work has shown~     considerable inter-hospital variation in emergency laparotomy outcomes within the United~     Kingdom. It is unknown whether there are significant differences in outcomes following~     laparotomy which may be explained by geographic factors.~      Aims~      The aim of this study is to describe emergency laparotomy outcomes in Scotland as they vary~     by the urban-rural nature of the patient's home location and travel time from hospital.~      Methods~      This research study is a retrospective observational enquiry which will utilise~     administrative data from the Information Services Division (ISD) of NHS National Services~     Scotland. Patient episodes will be identified by a set of procedure codes for emergency~     laparotomy, and the urban-rural classification of patients will be derived from postcode~     data. Travel time from hospital will also be derived from postcode data. The investigators~     will study a 10 year period from January 2001 to December 2010.~      The primary outcome measure will be risk-adjusted 30 day/inpatient mortality, and secondary~     outcome measures will be 30 day readmission rate, 30 day re-operation rate and post-operative~     length of stay.~   "
118386|NCT02017964|"~     This phase II trial studies how well combination chemotherapy works in treating younger~     patients with newly diagnosed, non-metastatic desmoplastic medulloblastoma. Drugs used in~     chemotherapy, such as vincristine sulfate, cyclophosphamide, methotrexate, etoposide, and~     carboplatin, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing.~   "
118387|NCT02017951|"~     Introduction~      Appendicitis is a common condition which represents a significant resource burden for the~     Scottish National Health Service (NHS). It is unknown whether there are significant~     differences in outcomes following appendicectomy which may be explained by geographic~     factors.~      Aims~      The aim of this study is to describe appendicectomy outcomes in Scotland as they vary by the~     urban-rural nature of the patient's home location and travel time from hospital.~      Methods~      This research study is a retrospective observational enquiry which will utilise~     administrative data from the Information Services Division (ISD) of NHS National Services~     Scotland. Patient episodes will be identified by a procedure code for appendicectomy, and the~     urban-rural classification of patients will be derived from postcode data. Travel time from~     hospital will also be estimated through postcode data. The investigators will study a 10 year~     period from January 2001 to December 2010.~      Primary outcome measures will be risk-adjusted 30 day/inpatient mortality, 30 day readmission~     rate, 30 day re-operation rate, length of stay and negative appendicectomy rates.~   "
118388|NCT02017938|"~     Fatigue is one of the most common symptoms in individuals with Parkinson's Disease (PD). Past~     researches indicated that more than half of the individuals with PD demonstrated fatigue~     symptom. The severity of fatigue was also correlated to the quality of life in individuals~     with PD. Finding the contributions of the central and the peripheral factors to fatigue,~     building reliable fatigue indexes, and developing an effective training program for~     individuals with PD are very important.~      The purpose of this project is to develop non-invasive method to monitor central and~     peripheral fatigue, to establish Virtual Reality(VR) anti-fatigue ergo cycling training~     paradigm, and to evaluate the long term training effect in individuals with PD.~   "
118389|NCT02017925|"~     This randomized clinical trial studies pulmonary rehabilitation in improving lung function in~     patients with locally advanced non-small cell lung cancer undergoing chemoradiation.~     Individualized exercise rehabilitation programs may reduce breathing problems and improve~     quality of life in patients with non-small cell lung cancer. It is not yet known whether~     pulmonary rehabilitation is more effective when started during or after cancer treatment.~   "
118390|NCT02017912|"~     This is a multi-center, randomized, double blind, placebo controlled study to evaluate the~     safety and efficacy of autologous (self) transplantation of Neurotrophic factors-secreting~     Mesenchymal Stromal Cells (MSC-NTF, NurOwn™) in patients with ALS .~      MSC-NTF cells are a novel cell-therapeutic approach which is expected to effectively deliver~     Neurotrophic factors, which are potent survival factors for neurons, directly to the site of~     damage.~   "
118475|NCT02016807|"~     RATIONALE: Polymerized (cross-linked) sucralfate malate paste (ProThelial) may be an~     effective single therapy approach for the management of chemoradiation mucositis, treating~     and preventing its occurrence in the oral cavity, esophagus, stomach, small and large~     intestine.~      PURPOSE: This observational multi-phase trial is studying how well polymerized (cross-linked)~     sucralfate malate paste (ProThelial) works to prevent and treat mucositis in adult patients~     who are to receive or have received chemo/radiation therapy that have caused or is~     anticipated to cause mucositis in the oral cavity, esophagus, stomach, small or large~     intestine. The Phase IV study addresses prevention and treatment in the oral cavity. The~     Phase I study addresses prevention and treatment in the esophagus, stomach, small and large~     intestine.~   "
118391|NCT02017899|"~     This Phase 1 clinical trial is aimed to evaluate the safety and immunogenicity of 3 doses of~     5 sequentially escalating dosages of a candidate vaccine against Shigella sonnei (1790GAHB~     vaccine) administered by intramuscular route in healthy adults (18 to 45 years of age at~     enrollment). The safety profile of the 1790GAHB vaccine is evaluated in comparison to that of~     placebo (GAHB-Placebo), constituted by an aluminum hydroxide suspension having the same~     concentration as study vaccine formulations. A total of 50 eligible subjects will be assigned~     to one of five sequential cohorts of 10 subjects each.~      Within each cohort, in an observer-blind fashion, subjects will be randomized to receive~     three vaccinations, four weeks apart, of either 1790GAHB vaccine (at five antigen~     concentrations) or GAHB placebo. A Data Safety Monitoring Board will be in place to receive a~     summary of all safety data obtained during one week follow-up post-first vaccination with the~     lower dose. Based on evaluation of the safety data, the Data Safety Monitoring Board will~     make a recommendation, as to whether the next cohort should be vaccinated with higher antigen~     concentration or not.~      Expected duration of the study for an individual subject is 9 months. Each subject will be~     followed-up for 6 months after the 3rd vaccination.~   "
118392|NCT02017886|"~     To evaluate the effect of daily ingestion of the probiotic Lactobacillus reuteri on the~     levels of secretory IgA and the cytokines Il1-beta, IL-6, IL-8 and IL-10 in saliva of healthy~     young adults.~   "
118393|NCT02017873|"~     The main objective of this study is to evaluate the effectiveness and longevity of color and~     Tooth sensitivity of patients undergoing home whitening peroxide 10% carbamide ( Whiteness~     Perfect , FGM , Joinville , Santa Catarina , Brazil) , and the relationship with the~     cigarette use for tooth whitening. They will be selected 120 patients with incisors darker~     than A2, higher plants will be divided into 2 groups per center (n = 30 ) , GE - Group~     Experimental ( smoking) and GC - Group Control ( non-smoking) . For the two groups will be~     used Carbamide peroxide 10% for 3 hours daily for a period of 3 weeks. Color will evaluated~     through the Vita Classical scale and Vita Easyshade Spectrophotometer in the periods: Home ,~     for tooth whitening (1st , 2nd and 3rd week) and post- whitening ( 1 week and 1 month , 2 and~     3 months). Patients recorded the perceived sensitivity through Numerical Analogue Scale (NRS~     ) with values from 0 to 4, where 0 = no sensation, 1 = mild, 2 = moderate, 3 = severe and 4 =~     significant , also in the Visual Analogue Scale (VAS ), with values from 0 to 10 where 0 = 10~     = severe tenderness and sensitivity. for color analysis will be made two-way ANOVA (group vs.~     treatment time ), being Over time the repeated measure ( α = 0.05). Test will be held on~     Tukey to contrast the average ( α = 0.05). The sensitivity will be evaluated by the Fisher~     exact test . It is expected that there is no difference on the effectiveness of home~     whitening and tooth sensitivity between smokers and nonsmokers.~   "
118394|NCT02017860|"~     The purpose of this study is to collect and assess long-term safety of everolimus in patients~     who are currently receiving everolimus treatment in a Novartis-sponsored, Oncology CD&MA~     study that has reached its study objectives, are not progressing on the current study~     treatment as defined by the parent protocol and are unable to access everolimus treatment~     outside of a clinical study. Parent studies eligible to participate in the roll-over study~     will be decided by Novartis. Investigator initiated trials (IITs) will not be included. The~     primary objective of the parent study must have been reached and the parent study must be in~     the process of being completed and reported.~   "
118395|NCT02017847|"~     Aim of this study is to identify intensity cut off points for physical activity in a~     population over the age of 70.~   "
118396|NCT02017834|"~     The harmonic scalpel is a tool that may reduce operative blood loss. Some studies also~     indicate it may result in faster surgery. A recently published randomized study from our~     group shows the harmonic scalpel reduces blood loss in neck dissection but it did not offer~     any reduction in OR time. The present study investigates the utility of the harmonic scalpel~     in resections involving removal of oral cavity tissues as well as the neck. Oral cavity~     resections are especially prone to blood loss and we believe the harmonic scalpel will confer~     benefits in this type of surgery, potentially reducing the need for blood transfusion.~   "
118397|NCT02017821|"~     Physical health does not have a high priority in today's treatment of patients with substance~     use disorder (SUD) patients have a poor physical health not only due to injuries related to~     the substance abuse, but also because of the lifestyle that addiction causes. There are today~     few studies that provide information about SUD patients' physical health. One of the~     project's aims is to document the physical health of SUD patients in treatment, using~     objective measures. After completion of various physical tests, an 8 week period of high~     intensity aerobic training intervention will follow. It will be investigated if the SUD~     patients are able to engage and participate throughout the whole training intervention, to~     what degree the participants improve their physical health and the effect of physical health~     improvement on substance abuse treatment.~   "
118398|NCT02017808|"~     This is a prospective, observational, single-blinded, longitudinal, 24-month OCT study of the~     evolution of axonal loss, as evidenced by loss of RNFLT and TMV, in RRMS patients treated~     with GA and in healthy controls.~   "
118399|NCT02017795|"~     Objectives:~      The disease being studied is asthma. The main objective of this study is to assess the~     feasibility of the recruitment goals and also the logistical issues related to use of~     tele-health technology in developing electronic asthma action plan (eAAP) and communicate~     with asthma patients in a time period of 24 months. The goals are: 1) enable asthma patients~     to self-manage their asthma symptoms. The secondary, 2) help care providers to intervene~     appropriately based on the patient's health status. The secondary objective is to explore the~     cost-benefit and cost-effectiveness of the proposed technology. Our research group proposes~     to complete a feasibility study, with an interim analysis for a formal power calculation and~     then acquire ethics to report these results and study design with anticipated publication~     prior to proceeding with a full randomized controlled trial to assess the efficacy of this~     intervention. The outcome measure will be assessed and data will be presented in a 24-month~     time frame.~      Aims and goals:~      The main aim of our proposed study is to assist asthma patients to practice asthma~     self-management at home that will eventually enable them to control their asthma, and~     specifically, prevent asthma exacerbation. Therefore, the ultimate goal of our proposed study~     is to improve patient health outcome via enhancing patient-physician interaction and using a~     more practical asthma action plan model (eAAP) that could be followed easily by the patient~     and their doctor.~      Our hypothesis is that asthma patients who have access to the electronic online action plan~     complimented by weekly text messages to reinforce adherence will have a reduced rate of~     asthma exacerbation. We further hypothesize that these subjects will have an improvement in~     secondary measures including quality of life, better asthma control and patient satisfaction.~     We also anticipate that such an approach in asthma management will be cost-effective as~     outlined below.~   "
118476|NCT02016794|"~     Degenerative cervical spine conditions lead to chronic neck and arm pain. Surgical treatment~     may require anterior decompression and fusion, which usually is established with a cage~     implant. The Anterior Cervical Interbody Spacer (ACIS) is such a cage.~   "
118400|NCT02017782|"~     The aim of the study is to provide information which may help to improve the quality of the~     life of persons exposed to indoor environments in Danish dwellings.~      The experiment will document if dust and ozone contribute to deterioration of indoor air~     quality and to the occurrence of symptoms and health effects.~      The study is aimed at testing the hypothesis that the presence of ozone potentiate the health~     and comfort effects of dust exposure in the indoor environment.~      Testing this hypothesis will be based on the following questions:~      Does house dust and ozone in concentrations frequently encountered in Danish dwellings cause~     unwanted health effects either by themselves or by interaction?~      If so, does the presence of ozone potentiate the expected irritative effects of dust?~      The challenge of these hypotheses will be made as a controlled experiment on humans in a~     climate chamber under controlled exposure conditions.~      This controlled human experiment should be able to substantiate the findings from the~     intervention studies.~      Furthermore, they ideally reflect something relevant to the general public and therefore~     should have maximum public appeal and application possibilities.~   "
118401|NCT02017769|"~     We want to study whether MRI can be useful in diagnosing and monitoring patients with CIDP in~     maintenance treatment with immunoglobulin~   "
118402|NCT02017756|"~     Stroke is the first and the fourth leading cause of death in the United States and China,~     respectively. Disruption of cerebrovascular vulnerable atherosclerotic plaque is the major~     etiology of ischemic stroke. Therefore, early detection and treatment of vulnerable plaques~     occurring at the feeding arteries to brain (cerebral arteries) will be helpful for prevention~     of stroke.~      Atherosclerosis is a systemic disease that usually affects multiple vascular beds. Previous~     studies have shown that these high risk lesions in different segments of cerebral arteries~     (intracranial and extracranial arteries) might be racially specific. It is reported that, in~     stroke patients, intracranial vulnerable plaques are prevalent in Asian populations whereas~     atherosclerosis more frequently involves extracranial carotid arteries in American subjects.~     However, these findings are based on angiographic imaging approaches via measuring arterial~     luminal stenosis. Because the atherosclerotic plaque often appears as outward expansion,~     namely positive remodeling during progression, measuring luminal stenosis will underestimate~     the disease severity. Hence, directly viewing the plaque in the vessel wall is strongly~     suggested in order to objectively evaluate the cerebrovascular vulnerable plaque.~      High resolution, black-blood magnetic resonance (MR) imaging has been widely used to~     accurately characterize carotid vulnerable plaque in the last two decades. The aim of using~     MR black-blood techniques is to suppress the blood signal (black) to enhance the signal~     contrast between the vessel wall and blood in the arterial lumen. Excellent agreement has~     been achieved between MR imaging and histology in identification of plaque components, such~     as intraplaque hemorrhage and lipid core. For assessing carotid plaque, MR imaging is~     superior to computed tomography and ultrasound imaging techniques due to its advantages~     including noninvasive imaging, lack of ionizing radiation, excellent soft tissue resolution,~     and multi-parametric image acquisition.~      The Investigators hypothesize that there are specific characteristics in carotid vulnerable~     plaques in Chinese patients with ischemic cerebrovascular events such as ischemic stroke and~     transient ischemic attack (TIA). This study seeks to investigate the characteristics of~     vulnerable plaque in carotid arteries using high resolution, black-blood MR imaging in~     patients with recent TIA or ischemic stroke.~      This is a cross-sectional, multicenter study. A total of 1000 patients will be recruited from~     more than 10 different hospitals across China within 3 years. All patients will undergo MR~     imaging for brain and carotid arteries within two weeks after symptom onset. The prevalence~     of carotid vulnerable plaque and its correlations with brain ischemic lesions, traditional~     risk factors, and regional distribution of China will be determined.~   "
118403|NCT02017743|"~     This study is a multicenter post authorization observational study. Cancer patients diagnosed~     with non high risk VTE and are followed up in an outpatient setting will be treated with LMWH~     and the data will be recorded. Since this is an observational study there are no specific~     treatment protocols, i.e., patients will be treated according to the best investigator's~     criteria. Treatment protocol will be based on the routine treatment practice of the involved~     investigator. Patients to enroll will be cancer patients diagnosed for VTE and who are able~     to receive outpatient LMWH treatment. There will be no specific hypothesis to be tested.~   "
118404|NCT02017730|"~     The purpose of this study is to assess the safety and tolerability of a novel positron~     emission tomography (PET) tracer [11C]BMT-136088 in healthy adult subjects for measurement of~     availability of Lysophosphatidic Acid (LPA1) receptors in the human lung and to use this~     tracer to assess LPA1 receptor occupancy using [11C]BMT-136088 in the human lung following~     oral administration of Bristol Myers Squibb (BMS)-986020.~   "
118405|NCT02017717|"~     The purpose of the study is to compare the efficacy and safety of nivolumab administered~     alone versus bevacizumab in patients diagnosed with recurrent glioblastoma (a type of brain~     cancer, also known as GBM), and to evaluate the safety and tolerability of nivolumab~     administered alone or in combination with ipilimumab in patients with different lines of GBM~     therapy.~   "
118406|NCT02017704|"~     This research is being done to compare the effectiveness of high dose endorectal~     brachytherapy (END-HDR) and the standard treatment option of chemoradiation with Capecitabine~     in the treatment of cancer of the lowest part of the bowel (rectum).~   "
118407|NCT02017691|"~     Objective: Objective of this pilot feasibility study is to monitor crSO2 using NIRS INVOS~     5100 (Somanetics, USA) in addition to SpO2 monitoring to guide supplemental oxygen delivery~     and respiratory support based on both measurements in preterm neonates during the first 15~     minutes after birth.~      Patients: Preterm neonates <34+0 weeks of gestation born via caesarean section and/or who~     require respiratory support will be eligible for the study.~      Design: A prospective two-centre randomized controlled pilot feasibility study~      Methods: Study group: Pulse oximetry will be used to measure SpO2 and heart rate as routine~     non-invasive monitoring in the first minutes of resuscitation. In addition during the first~     15 minutes NIRS measurements will be recorded. crSO2 measurements in addition SpO2~     measurements will be used to guide supplemental oxygen support and respiratory support during~     the first 15 minutes after birth. Control group: Only SpO2 measurements will be used to guide~     supplemental oxygen support and respiratory support during the first 15 minutes after birth.~      Hypothesis: Supplemental oxygen support and respiratory support guided by crSO2 and SpO2~     measurements will reduce the time in % minutes of crSO2 <10th or >90th centile in preterm~     neonates during the first 15 minutes after birth~      Outcome Parameter: Primary outcome parameter will be duration in % minute of crSO2 <10th or~     >90th centile.~   "
118408|NCT02017678|"~     This is a single-arm open-label Phase 2 study in patients with peritoneal carcinomatosis of~     ovarian origin that are not eligible for curative treatments. Patients will receive 5 weekly~     IV infusions of JX-594 until radiographically determined progressive disease. Patients will~     be allotted in a 1:1 ratio to undergo a laparoscopy and tumor biopsy 10 days after dose 1 or~     10 days after Dose 5. Patients will be monitored on study until evidence of progression or~     death or for 12 months post treatment.~   "
118477|NCT02016781|"~     This study is designed as a multicenter trial, with biological assignment to one of two study~     arms; Arm 1: Reduced intensity conditioning allogeneic hematopoietic cell transplantation~     (RIC-alloHCT), Arm 2: Non-Transplant Therapy/Best Supportive Care.~   "
118409|NCT02017665|"~     Worldwide, central nervous system infections such as inflammation of brain (encephalitis),~     inflammation of meninges (meningitis) and sudden onset of weakness of muscles which maybe~     infectious in origin result in significant illness and death and healthcare costs. Vast~     majority of central nervous system infections remain without an identifiable cause. There is~     also concern about new and emerging infections.~      This study thus intends to fill in the gaps in knowledge with regards to central nervous~     system infections in Singapore to give a thorough description of burden of causes of central~     nervous system infections and detection of outbreaks of new pathogens. Patients suspected of~     central nervous system infection will be recruited from 5 restructured Singapore hospitals~     and their blood and other clinical specimens will be sent for testing. Patients will also be~     followed up to assess long term outcomes and socio-economic costs of these infections. This~     will help clinicians, policymakers and public health officials in estimating financial and~     societal costs of CNs infections in Singapore.~   "
118410|NCT02017652|"~     CASMED, INC. wishes to validate the next generation FORE-SIGHT-II (FS-II) NIRS tissue~     oximeter monitor for neonatal brain and somatic tissue oxygen saturation (StO2) measurements.~     This monitor was recently FDA cleared for use on adult subjects.~   "
118411|NCT02017639|"~     Primary Objective:~      To evaluate the effect of a single 200 mg subcutaneous injection of sarilumab on the~     pharmacokinetics of simvastatin in patients with rheumatoid arthritis~      Secondary Objective:~      To describe the safety and efficacy (exploratory) of sarilumab~   "
118412|NCT02017626|"~     The aim of this study is to investigate the safety and tolerability of Subcutaneous~     Immunotherapy treatment (SCIT) with incremental doses of a modified recombinant fish~     parvalbumin (mCyp c 1) quantified in mass units:~      To establish a safe dose of the candidate hypo-allergen in human subjects and To study the~     pharmaco-dynamics of the hypo-allergen administered to human subjects.~      The study is performed as a placebo-controlled double-blinded randomized trial with 24 fish~     allergic patients allocated into three different groups of eight.~   "
118413|NCT02017613|"~     The objective of this study is to evaluate the safety and efficacy of RP6530, a dual PI3K~     delta/gamma inhibitor in patients with hematologic malignancies.~   "
118414|NCT02017600|"~     Investigator will assign 53 patients who had been histologically proven localized squamous~     cell carcinoma of esophagus to receive the induction chemotherapy regimen of ND-420 50 mg/m2~     on day 1, cisplatin 70 mg/m2 on day1, plus fluorouracil 700 mg/m2 daily, day1 to day4, every~     3 weeks for 2 cycles and then followed by surgical resection. The successful rate of complete~     treatment per protocol and complete resection will be the primary variant to evaluate in our~     study.~   "
118415|NCT02017587|"~     The objective of the study is to procure blood (plasma, serum, RNA and PBMC samples) from~     approximately 40 chronic HBV for biomedical research program led by VGTI Florida.~   "
118416|NCT02017574|"~     Stroke is one of the leading causes of chronic disability in Veterans. Stroke is associated~     with significant loss of mobility, increased risk of falling, cardiovascular disease,~     depression and neuro-cognitive impairment. These deficits negatively impact the independent~     completion of the Activities of Daily Living (ADLs). Task-oriented training has emerged as~     the dominant therapeutic intervention in the rehabilitation of chronic stroke victims. The~     effectiveness of these interventions may be enhanced through facilitation of implicit~     knowledge rather than explicit knowledge. Specifically, implicit learning increases retention~     and improves transfer of the improved motor function outside of the lab environment.~     Moreover, implicit motor control reduces the burden imposed on cognitive resources as the~     skill is performed automatically (i.e. do not have to 'think' about it). The amount and type~     of feedback individuals receive while learning a new task (or relearning in the case of~     rehabilitation) has been shown to influence the type of learning (i.e. implicit or explicit).~     Thus the purpose of the current study is to determine the effect of different types of~     feedback during motor learning on the learning type and the resultant impact on functional~     outcomes (i.e. motor performance, retention, and cognitive workload) in chronic stroke~     patients.~   "
118417|NCT02017561|"~     Metabolic syndrome (MS) is a cluster of risk factors for cardiovascular disease with~     increasing prevalence worldwide and insulin resistance is central to its pathophysiology and~     multi-organ deleterious effects. One of the most affected organs, the heart, undergoes a~     remodeling process with an increase in fibrous tissue that impairs global cardiac function.~     Considering that myocardial fibrosis increases myocardial stiffness, one important~     determinant of diastolic function, it probably contributes decisively to subclinical left~     ventricular diastolic dysfunction (DD) and heart failure with preserved ejection fraction in~     patients with MS.~      Since insulin resistance is a dominant player in the pathophysiology of MS, improvement of~     the metabolic profile of these patients with metformin might be associated with favorable~     remodeling of myocardial structure and an improvement in myocardial function. Metformin is a~     widely used drug to treat type 2 diabetes mellitus and is considered an option in the~     treatment of high-risk non-diabetic patients with MS, in addition to lifestyle counseling~     including a healthy diet and physical activity.~      In this way, we aim to: i) assess if treating non-diabetic patients with MS and DD with~     metformin in addition to lifestyle counseling decreases cardiac fibrosis and improves~     diastolic function and assess its impact in functional capacity and health-related quality of~     life (HRQoL); ii) evaluate if biomarkers of cardiac remodeling and inflammation are~     predictive factors of response to metformin treatment in these patients.~      This is a prospective, randomized, open-label, blinded-endpoint (PROBE) trial (scheduled~     follow-up of 24 months) with 2 arms: lifestyle counseling only and lifestyle counseling plus~     metformin (maximum dose of 1000mg twice daily).~      The primary endpoint will be change in change in mean of septal and lateral early diastolic~     mitral annular velocities (E') (at the end of the 24 months of follow-up).~      The secondary endpoints will include a composite of major cardiovascular events; diastolic~     function parameters at rest; plasma levels of insulin, glucose, insulin resistance index,~     NTproBNP, high-sensitivity C-reactive protein, tumor necrosis factor-α (TNFα), tissue~     inhibitor of matrix metalloproteinase type 1 (TIMP1) and growth differentiation factor-15~     (GDF-15); functional capacity; epicardial, pericardial and abdominal adipose tissue volumes,~     and coronary calcium score; HRQoL.~   "
118418|NCT02017548|"~     In a multicenter, randomized clinical trial of default options in advance directives among~     patients with incurable diseases, we will determine whether this simple and readily scalable~     intervention can improve patients quality of life and reduce resource utilization without~     reducing the number of days that patients are alive and living outside of an acute-care~     hospital.~   "
118419|NCT02017535|"~     The purpose of the study is:~        1. To find out how long teenagers getting talk therapy (interpersonal psychotherapy) for~          depression should get therapy before the therapist decides whether or not the teenager~          is improving enough, and~        2. To compare two ways of providing treatment to teenagers who have not improved enough.~   "
118420|NCT02017522|"~     In a study of Cardiac sarcoidosis, a serious heart condition, a radiotracer is being used to~     examine inflammation.~   "
118424|NCT02017470|"~     This research focuses on health needs, constructed meanings of health, and meaningful health~     promotion tactics among women who are heart disease patients. Women with heart disease are~     considered as a highly vulnerable group for cardiovascular disease-related deaths in~     Singapore. Because the culture-centered approach has previously demonstrated that~     community-driven participatory processes of the Culture-Centered Approach (CCA) foster~     positive changes in health outcomes, this project highlights involvement of community members~     in developing effective health promotion regarding heart health. Rather than relying solely~     on interventions created by outside experts, The investigators aim to engage in Heart Health~     promotion that is meaningful through the involvement of these community members in processes~     of change.~      Thus, the investigators seek to engage these women who are heart disease patients in~     developing a heart health intervention that is beneficial to them. Through in-depth~     interviews, focus groups, the formation of advisory boards, and community-wide dialogue~     workshops led by these women, the investigators seek to identify specific heart health~     promoting strategies and tactics that are meaningful to the lived experiences of the women.~     As part of the overall solution, this project will work alongside the Women's Heart Health~     Clinic to create training materials and disseminate findings based on our analysis.~      Methodology:~      As far as the methodology, the investigators are using the Culture-Centered Approach (CCA) as~     well as using biomedical measures for evaluation. First, an advisory board will be formed to~     inform each step of our methodology and data analysis. First, the investigators will~     randomize one group of patients into the control group and one group into the experimental~     group. The investigators will conduct baseline measures for both groups. For the control~     group, the investigators will measure biomedical data at 3 times (3 months, 6 months, and 12~     months). For the experimental group, the investigators will create advisory board that will~     consist of approx. 4 physicians and 6 patients. In-depth interviews will be conducted with~     women who have experienced CVD and who live in Singapore. Each interview will last a maximum~     of 90 minutes. Interviewees will be asked questions about how they understand health, their~     health experiences, and the obstacles they face in accessing health care in Singapore. Data~     from the interviews will be analyzed with the advisory board and will be used to guide~     discussion for the focus groups of women in the experimental group.~      Focus group sessions, each lasting a maximum of 90 minutes, will be conducted with the~     patients in the experimental group. In each session, the participants will collectively~     develop potential solutions for the issues that emerged during the earlier interviews.During~     the one-year period of study, a participant in the experimental group can participate in one~     or many of the one-on-one interviews, focus groups, or other activities planned based on the~     feedback of the participants. Based on the information given in the interviews, advisory~     board meetings, and focus groups, an intervention will be designed and carried out for the~     experimental group. This group will also be evaluated at 3 time points (3 months, 6 months,~     and 12 months) in addition to baseline.~   "
118425|NCT02017457|"~     The present project is a multicenter, phase II trial which aims at evaluating if the~     administration of azacytidine (Vidaza®) combined to donor lymphocyte infusion (DLI) could~     improve the response rate to DLI in the population of patients with relapsed acute myeloid~     leukemia (AML) and myelodysplastic syndrome (MDS) after allogeneic hematopoietic stem cell~     transplantation.~   "
118426|NCT02017444|"~     Assessing the safety and effectiveness of a 11-βhydroxysteroid dehydrogenase type 1 inhibitor~     (AZD4017), in a placebo controlled trial, in acute idiopathic intracranial hypertension (IIH)~     IIH is a condition of young, overweight women with characteristic raised intracranial~     pressure (pressure around the brain) leading to papilloedema (swelling of the nerve supplying~     the eye), visual loss and headaches. Medical literature (Cochrane review) demonstrates there~     is little evidence for the treatments used for IIH. Weight control appears the most effective~     method of improving symptoms but weight loss is difficult to maintain. 11β-hydroxysteroid~     dehydrogenase type 1 (11β-HSD1) is an enzyme which regulates local steroid levels and our~     previous research suggests it may influence the production of brain fluid(cerebrospinal fluid~     or CSF). 11β-HSD1 levels fall with weight loss and this is associated with with decreased~     intracranial pressure.~      Our primary outcome is to determine whether AZD4017, an inhibitor of 11β-HSD1, will reduce~     the pressure in the brain and as a consequence improve IIH. Patients are eligible to enter~     the study if they are between 18-55 years old with acute (<6 months) IIH, signs of active~     disease (papilloedema and raised CSF pressure (>25 cmH20)), no other major illnesses and have~     no plans for pregnancy during the study period.~      This is an MRC funded single centre, phase II, double-blinded, randomised control drug trial.~     It will be conducted at the University Hospital Birmingham and the University of Birmingham~     will act as Sponsor. Eligible participants will be randomly assigned to AZD4017 or a placebo~     ('dummy' with no active drug) for 3 months with a follow up a month later. Investigations~     during the study will include bloods, urine samples, pregnancy tests, lumbar punctures, DXA~     scans and small fat/skin biopsies. Participants will benefit from increased monitoring and a~     potential improvement in their condition.~      We hypothesise that specific inhibition of 11β-HSD1 will decrease intracranial pressure and~     consequently treat patients with IIH, thus opening a new and entirely novel therapeutic~     avenue.~   "
118427|NCT02017431|"~     The study probes the effects of combined exposures to diesel exhaust and allergens on lung~     function and on the immune system, specifically focusing on the ability of a particle~     depletion technique to attenuate effects we and others have seen previously. Individuals are~     exposed to either filtered air (FA), carefully controlled levels of diesel exhaust (DE) or~     particle-depleted diesel exhaust (PDDE) in our exposure chamber, after which the~     investigators will administer an inhaled allergen challenge. 48h later, a procedure called~     bronchoscopy is used to collect samples from the lungs. After 1 month, the entire procedure~     is to be repeated with one of the alternate exposures. This will be repeated 4 times (4~     exposures; 2 filtered air, 1 diesel exhaust, 1 particle-depleted diesel exhaust)~   "
118428|NCT02017418|"~     This study was designed to test whether two zeaxanthin formulations (supplements containing~     different nutritional compounds with zeaxanthin and omega fatty acids being the primary~     ingredients of interest) influenced visual motor function. Visual motor function refers to~     the processing speed of the visual system and how individuals respond behavioral to visual~     stimuli (e.g., reaction time).~   "
118429|NCT02017405|"~     The purpose of this study is to determine the digestibility of serum-derived bovine~     immunoglobulin protein isolate in healthy adults. The information generated may help~     elucidate SBI's mechanism of action.~   "
118430|NCT02017392|"~     The purpose of this study is to determine whether the compound lidocaine cream is effective~     in preventing postoperative agitation in patients with endotracheal intubation for general~     anesthesia.~   "
118431|NCT02017379|"~     This is a study comparing the effect of erythromycin or metoclopramide, 2 prokinetic drugs~     (Drugs which are known to speed up the emptying of the stomach or in other words to move the~     blood out of the stomach faster) given before endoscopy to patients with upper~     Gastrointestinal bleeding compared to patients who will not receive either of these~     medications before their endoscopy.~   "
118432|NCT02017366|"~     It is well known that there is a considerable postoperative weight loss in patients~     undergoing esophageal resection for cancer.~      We believe that this weigh loss can be limited by administering postoperative enteral feeding~     (target: 1000 kCal/ day) via feeding jejunostomy for at least 6 weeks postoperatively.~      We hypothesize that patients undergoing esophageal resection for cancer will have a better~     overall survival with postoperative additional enteral feeding than when on regular oral diet~     alone.~   "
118433|NCT02017353|"~     This therapy aims to determine whether curcumin can inhibit tumor induced inflammation in~     patients with endometrial carcinoma. In addition, curcumin could possibly induce a better~     functioning of chemotherapy and a decrease in toxicity from chemotherapy. Various studies~     have demonstrated that curcumin can have an effect on tumor growth and the development of~     metastases.~   "
118562|NCT02015676|"~     This study will define an optimal chemotherapy dose regimen of Myocet in combination with~     paclitaxel and intravenous Herceptin and will evaluate the efficacy and safety of this dose~     regimen in patients with metastatic or locally advanced breast cancer and HER2~     overexpression. The anticipated time on study treatment is 3-12 months.~   "
118434|NCT02017340|"~     Alzheimer's disease (AD) is an ever-increasing public health concern among the aging~     population and is the most common form of dementia affecting more than 15 million individuals~     worldwide and around 5 million Europeans. The direct and indirect costs of AD and other~     dementias amount to more than €440,000 million each year (www.alz.org, 2010).~      Even modest therapeutic advances that delay disease onset and progression could significantly~     reduce the global burden of the disease and the level of care required by patients. While~     there are symptomatic-based drug therapies available for AD, these medications do not prevent~     the disease process itself. There is therefore an imperative to develop new treatments for AD~     that have disease modifying effects. This double-blind placebo controlled study will test the~     efficacy and safety of nilvadipine in 500 subjects with mild to moderate AD over a treatment~     period of 18 months. There is a strong scientific rationale for this study: Nilvadipine, a~     licensed calcium channel enhances Aß clearance from brain and restores cortical perfusion in~     mouse models of AD. Nilvadipine is safe and well tolerated in AD patients and clinical~     studies with this medication have shown stabilization of cognitive decline and reduced~     incidence of AD, pointing to both symptomatic and disease modifying benefits. Male and female~     patients with mild to moderate AD aged between 50 and 90 with a range of medical morbidities~     and frailty will be included in the study. If this trial is successful, nilvadipine would~     represent an advance in the treatment of AD patients and would have a major impact on the~     health and social care costs incurred in Europe by this neurodegenerative disorder.~     Furthermore, the creation of the NILVAD network will support future clinical trials and~     research innovation in AD across Europe.~   "
118435|NCT02017327|"~     Primary objective:~      The primary objective is to demonstrate the superiority of Monoprost® versus Lumigan® 0.01%~     and Lumigan® 0.03% Unit Dose in term of safety with respect to the assessment of conjunctival~     hyperaemia in the worse eye at Day 84.~      The conjunctival hyperaemia will be scored using the MacMonnies photographic scale (0 to 5).~   "
118436|NCT02017314|"~     The aim of the study is to observe if any correlation between Body mass index and VAS values~     exists in patients who has gone under abdominal surgery.~      Group I : Patients with BMI<30 Group II: Patients with BMI between 30 and 34.9 Group III:~     Patients with BMI between 35 and 39.9 Group IV: Patients with BMI between 40 and 49.9 Group V~     : Patients with BMI >50~      After the end of surgery patients will be extubated and in the recovery room morphine PCA~     (patient-controlled analgesia) treatment will be started according to their adjusted body~     weight. When VAS values over 4,10 mg/kg Paracetamol IV will be used as an escape treatment.~     VAS values and Delivery and Demand of the PCA and additional need for analgesics will be~     recorded in the first 48 hours.~   "
118437|NCT02017301|"~     Patients with acute decompensation of cirrhosis, or acute on chronic liver failure often~     present with malnutrition, and due to the in-hospital stay, their nutritional intake can vary~     widely, with several periods of fasting, and sometimes insufficient nutritional support.~     Therefore patients are prone to develop malnutrition or, the already present malnutrition~     worsens its status.~      Our aim is to evaluate the daily changes in nutritional status in patients with acute~     decompensation of cirrhosis and evaluate the changes in plasma and serum biomarkers.~   "
118438|NCT02017288|"~     Background:~      - Cancer of the mouth and throat is one of the most common cancers in Taiwan. This cancer~     develops over several years, beginning as white or red patches in the mouth or throat that~     become growths. It can also cause a condition that leads to rigidity of the cheeks. The~     growths can be identified when a doctor looks into a person s mouth. It is currently not~     clear why some people with abnormal growths progress to cancer while others do not.~     Researchers want to better understand why some patients with early abnormal growths get late~     abnormal growths. They also want to understand why some people get abnormal growths again,~     even after they receive treatment.~      Objectives:~      - To understand why some people with precancerous lesions in their mouth develop cancer while~     others do not.~      Eligibility:~      - Adults 21 years and older, some with abnormal growths in the mouth, some without any, and~     some with head and neck cancer.~      Design:~        -  Participants will visit a hospital in Taiwan 2 times.~        -  At the first visit, participants will answer questions about their health, lifestyle,~          and family medical history. A doctor will examine the participant s mouth and take a~          small piece of any growth they see. They will do this with a brush. They will also~          photograph the participant s mouth. Participants will also give blood and saliva~          samples, plus a small sample of a mouth rinse.~        -  Participants who are diagnosed with a late abnormal growth that is not cancer will~          return for a second visit. They will answer the same questions and undergo the same~          procedures as at the first study.~   "
118439|NCT02017275|"~     PANDA III is sought to investigate the safety and efficacy of a PLGA-polymer with~     electro-grafting base layer sirolimus-eluting stent (SES) versus a PLA-polymer SES at 12~     months follow-up.~   "
118440|NCT02017262|"~     This project addresses the important public health need to reduce ethnic disparities in~     depression care by pilot testing and refining a culturally tailored, low-cost intervention~     for improving both depression and general medical outcomes among Latinos in safety net~     primary care settings. Cuerpo Sano, Mente Sana is a newly developed, lay-led, group~     self-management intervention that educates and empowers patients in their own health care and~     has the potential for widespread implementation and sustainability in primary care because it~     is responsive to patient, provider, and system preferences and needs. After completing an~     assessment of study clinic sites, we will conduct a pilot test of Cuerpo Sano, Mente Sana~     with 30 low-income, Spanish-speaking primary care patients. After reviewing pilot findings,~     we will revise the intervention and study plan, and will conduct a second pilot trial. After~     reviewing findings from this second trial, we will finalize the intervention and study plan~     in preparation for larger studies to test Cuerpo Sano, Mente Sana versus other interventions~     for addressing depression among Latinos in safety net primary care.~   "
118478|NCT02016768|"~     There is a relationship between CSM and hypertension, probably a cause/effect relationship,~     and investigators term this type of hypertension cervicogenic hypertension. Abnormally~     functioning serotonergic pacemaker cells in the dorsal raphe nucleus inappropriately activate~     and inhibit parts of the central and autonomic nervous systems as part of a chronic stress~     response, which causes hypertension and migraine. This theory is now being expanded to~     encompass both CSM and essential hypertension, the idea being that these two conditions are~     intimately related.~   "
118441|NCT02017249|"~     The purpose of this study is to learn more about the ability of a substance called arginine~     to improve the functioning of the immune system in people with a certain type of brain tumor.~     This could lead to improvements in a type of treatment for brain tumors called immunotherapy.~     The immune system includes organs, cells, and substances in the body that fight infection and~     disease. Immunotherapy is a type of treatment that uses the immune system as a tool to seek~     out and destroy abnormal cells. Immunotherapy requires that the immune system be working~     properly. Arginine is a normal component of protein (an amino acid) that we all consume in~     foods such as red meat, poultry, fish, and dairy products and that our bodies can make.~     Arginine helps the immune system function normally. Recent research has shown that certain~     types of brain tumors decrease the amount of arginine in the body leading to impaired immune~     system function. This may interfere with the ability of immunotherapy to fight abnormal~     cells. We would like to see if giving people with brain tumors arginine in powder form will~     make their immune systems work better.~   "
118442|NCT02017236|"~     The purpose of this study is to evaluate to determine the effect of food on the PK of a~     single dose of 600 mg Volitinib and its two major metabolites in healthy subjects.~   "
118443|NCT02017223|"~     This project proposes to use mobile devices to develop new tools for pediatric obesity~     prevention and treatment targeting underserved minority adolescent populations at high risk~     for obesity and related diseases. We will use off the shelf, validated and wearable wireless~     sensors to measure physical activity, blood pressure, sleep, heart rate, galvanic skin~     response and blood glucose levels and communicate the measured information to a mobile phone~     using a wireless interface. This will deliver a record of behavior and health data that is~     time-stamped, synchronized, and geographically localized using GPS to a secure server. Data~     will then be analyzed and displayed to participating health professionals to provide them~     with readily interpretable records of continuously monitored energy expenditure, recorded and~     synchronized with other essential biological, behavioral and geographical data. To accomplish~     this project, 50 African American and Hispanic youth (50% female, ages 12-17) will be~     recruited into the research in advisory capacities, to test the sensors during development,~     and to wear the sensors for three non-contiguous weeks. To test the sensors prior to use with~     minority youth, 30 college students age 18 and above will be recruited to try out the sensors~     in and outside of the laboratory in order to make sure that all sensors are in perfect~     working order before testing them in minority youth populations. An advisory group of medical~     professionals will be assembled to guide us through the process of developing a web interface~     that will ensure that the right information will be displayed in an easily interpretable~     fashion. The advisory group will participate in regular meetings to develop and test the web~     interface. Using the data acquired, health professionals will be able to visualize average~     amounts of physical activity, sleep, sedentary behaviors (daily or weekly) as well as daily~     patterns. Average blood glucose, heart rate, and stress levels (daily or weekly) as well as~     daily patterns will also be available. Practitioners will be able to see when and where~     activity and metabolic events are occurring, enabling preemptive and preventive strategies as~     well as targeted interventions to prevent and treat pediatric obesity in underserved and~     at-risk minority youth.~   "
118444|NCT02017210|"~     People who are overweight and/or obese usually are insulin resistant and so are at risk of~     type 2 diabetes. However, research has shown that some overweight and/or obese people remain~     insulin sensitive and healthy despite their weight.~      The investigators hypothesise that insulin-sensitive overweight and/or obese people maintain~     their insulin sensitivity and metabolic health over time. The investigators also hypothesise~     that the preservation of insulin sensitivity will be determined by key metabolic factors.~   "
118445|NCT02017197|"~     The purpose of this study is to assess whether the switch from branded to generic warfarin or~     between different generic warfarin tablets may cause fluctuation in the results of~     coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing~     them to unnecessary risks.~   "
118446|NCT02017184|"~     Soldiers are required to perform and maintain alertness in difficult environmental~     conditions. The sensor examined in this trail may indicate body core temperature elevation~     during exertion. 12 male volunteers will arrive to our lab and perform a protocol of sitting~     and walking in thermoneutral and hot environments with two core temperature sensors. The~     results obtained from them will be compared.~   "
118447|NCT02017171|"~     Despite improvements during the past 20 years in blood glucose and blood pressure control,~     diabetic kidney disease remains one of the most important causes of health problems in~     patients with diabetes. Novel treatments to complement blood glucose and blood pressure~     control are urgently needed. The goal of this study is to see whether a medication called~     allopurinol may help prevent loss of kidney function among people with type 1 diabetes.~     Allopurinol has been used for many years to decrease high blood uric acid and treat gout - a~     disease characterized by arthritis, especially of the foot joints. There is evidence~     suggesting that allopurinol might also be useful in people with diabetes who have normal or~     moderately impaired kidney function to decrease the risk of developing advanced kidney~     disease in the future. To prove this beneficial effect of allopurinol, we will be conducting~     an international clinical trial at eight diabetes centers, enrolling approximately 480~     patients with type 1 diabetes who are at increased risk of developing kidney disease.~     Participants will be randomly assigned to take allopurinol or placebo (inactive pill) for~     three years, during which they will be followed through periodical visits. To prevent any~     possible bias, neither the participants nor the clinical staff knows who is taking~     allopurinol and who is taking the placebo. Kidney function will be measured at the beginning~     and at the end of the treatment period to see whether patients taking allopurinol experience~     a slower loss of kidney function over time as compared to those taking the inactive pill. If~     this trial is successful, the reduction in health problems resulting from the prevention or~     delay of kidney function loss due to the use of allopurinol would have a major impact on the~     lives of type 1 diabetic patients as well as on society at large, significantly reducing the~     human and financial costs associated with diabetic kidney disease. Because of the emphasis on~     early intervention, the proposed trial, if successful, will establish a new paradigm in~     treatments to slow or prevent progression towards end stage kidney disease in type 1 diabetes~     far beyond anything achieved to date.~   "
118448|NCT02017158|"~     The purpose of this study is to develop, disseminate, and evaluate a web-based nutrition and~     gardening game using interactive, multiplatform and mobile gaming, rich narrative, a~     pedagogical agent, meaningful play, and experiential learning to prevent/treat obesity in~     minority 3-5th grade youth and their families.~   "
118449|NCT02017145|"~     The purpose of the current work is to determine the efficacy of the re-application of~     surgical prep solution in decreasing surgical site bacterial contamination following lower~     extremity surgery. Decreasing the extent of bacterial colonization of the skin surrounding~     the surgical site during the initial healing phases would theoretically decrease the rate of~     infection in high-risk persons.~   "
118479|NCT02016755|"~     The purpose of the study is to confirm the feasibility of study procedures and the~     tolerability of a new dose regimen of AMG0001 in subjects with Critical Limb Ischemia (CLI)~   "
118480|NCT02016742|"~     The purpose of this study is to characterise the pharmacokinetics, safety and tolerability of~     RDC5 given as a single dose to healthy volunteers at a number of different dose levels~   "
118481|NCT02016729|"~     Open-label, sequential dose escalation and expansion study of AMG 232 in subjects with acute~     myeloid leukemia.~   "
118482|NCT02016716|"~     The purpose of this study is to compare 2 formulations of romosozumab (AMG 785) on bone~     mineral density (BMD) in postmenopausal women with osteoporosis.~   "
118483|NCT02016703|"~     Purpose of this study: assess the maximum tolerated bolus dose of erythritol, delivered in a~     clear beverage, compared with placebo (saccharose) in 4-6 year old children.~   "
118450|NCT02017132|"~     Pomegranate has gained widespread popularity since the health effects of the whole fruit, as~     well as its juices and extracts, have been studied in relation to a variety of chronic~     conditions such as hypertension, diabetes, obesity, cancer and cardiovascular disease.~      The fruit consists of peel, seeds and berries or arils. The peel is rich in minerals and~     compounds such as polyphenols, but is not an edible part of the plant. In order to harness~     the benefits of all parts of the fruit, the whole fruit can be crushed and powdered and then~     easily consumed as pomegranate extract capsules.~      Pomegranate has been shown to be effective at reducing cardiovascular disease risk factors,~     particularly with respect to decreasing blood pressure and increasing insulin sensitivity.~     Dietary polyphenols may also suppress body fat growth. Recently, positive effects on fat~     reduction have been shown using pomegranate and its extracts. In animal models it has been~     shown for both extract and leaf that there were significant decrease in food consumption and~     body weight, inhibiting the development of obesity. In the few human studies, there appeared~     to be a trend towards a reduction in waist circumference and fat mass, plus a halt in body~     weight increase, for both juice and seed oil.~      This parallel, double blinded, randomised, placebo controlled trial aims to confirm previous~     results concerning the effect of whole pomegranate fruit on biochemical and physiological~     markers using a new pomegranate extract and to conduct original work to explore its effect on~     body weight, measurements and fat mass. Any similar interventions have not been double~     blinded or used pomegranate in extract form. Changes in physiological and biochemical markers~     will also be investigated.~      The study hypothesis is that pomegranate extract will reduce BMI and body weight, fat mass,~     body measurements and blood pressure.~   "
118451|NCT02017119|"~     Hepatic encephalopathy (HE) is an important complication of liver cirrhosis. Lactulose is a~     first line treatment for HE, but the adherence to this treatment is relatively low, due to~     side effects such as diarrhea, distention, etc.~   "
118452|NCT02017106|"~     Varicose veins of the leg often have superficial tributaries, which are often symptomatic and~     a major reason for coming to the doctor. When treating the main varicose vein inside the leg,~     some doctors prefer to remove these tributaries while others prefer to leave them. This trial~     aims to see if it is better to remove these veins at the time of the first laser procedure or~     better to leave them and only remove them when asked.~   "
118453|NCT02017093|"~     The purpose of this pilot study was to explore the impact of enhancement of the velocity~     component error in the course of reaching movements of the impaired/hemiparetic limb in an~     acute stroke subject. We hypothesized that the method would shift velocity profiles toward~     the optimal, resulting in a reduction in error. A prototype robot. This robotic device system~     has a two-dimensional motor, basic measurement capacities, and a robotic arm which is engaged~     to the subject's upper-limb in a sitting position.~      The enhancement of the velocity component error would shift velocity profiles toward the~     optimal, resulting in a reduction in error.~   "
118454|NCT02017080|"~     Non invasive methods: maternal antithyroid antibodies and ultrasound measurement of the fetal~     thyroid gland could be an important tool for detecting fetal thyroid dysfunction in mothers~     with autoimmune thyroid disease.~   "
118455|NCT02017067|"~     Previous studies have demonstrated that resistance training (RT) is beneficial to increase~     muscle strength, improve functional ability and the ability to rapidly produce force, known~     as the contractile rate of force development (RFD) in older adults. However, much less~     research has focused on the effect of RT on the lower extremity muscle strength, contractile~     RFD and impulse in middle-aged and older people with musculoskeletal conditions, especially~     for osteoporosis (OP) (or osteopenia) or knee osteoarthritis (KOA). Therefore, the purpose of~     this study was to investigate the effect of RT on the lower extremity muscle strength, RFD~     and impulse in middle-aged and older people with musculoskeletal conditions, especially for~     OP and knee OA (KOA). The investigators hypothesized that such a training program would lead~     to induce not only specific muscle strength enhancement but also an increment in contractile~     RFD and impulse.~   "
118456|NCT02017054|"~     The purpose of this study is to assess the feasibility of performing repetitive coronary~     angiograms via the radial approach~   "
118457|NCT02017041|"~     The purpose of this study is to evaluate the usability of an interactive smartphone~     application (app) designed to engage and support patients receiving bup/nal.~   "
118458|NCT02017028|"~     The aim of this study is to investigate the relation between the previous presence of~     endothelial dysfunction and the development of radial artery vasospasm during the~     trans-radial coronary evaluation.~   "
118459|NCT02017015|"~     The purpose of this study is to determine the safety and efficacy of nab-paclitaxel combined~     with gemcitabine in Chinese patients with metastatic pancreatic cancer.~   "
118460|NCT02017002|"~     Esophagectomy for esophageal cancer is a technically complex procedure which is associated~     with high perioperative mortality, even in high volume centers[1]. To facilitate the~     postoperative recovery of esophagectomies patients by reducing surgical trauma, an increasing~     number of surgeons have attempted minimally invasive esophagectomy (MIE) to treat patients~     with esophageal cancer.[2-10] However, there is no consensus regarding the optimal method for~     performing an esophagectomy with the minimally invasive surgical technique. In addition, the~     benefit of this approach has not been well confirmed based on the limited retrospective~     comparative studies at the present time [3, 11-12], although its potential benefit improving~     the immediate postoperative including the total morbidity and pulmonary complication has been~     demonstrated by meta-analyses[13]. Especially it is unclear whether adding laparoscopic~     procedures in MIE can contribute to further improvement of the perioperative outcome of the~     patients.[3] Previously, the investigators have found that adding of laparoscopic procedure~     in performing the esophageal reconstruction procedure after VATS esophagectomy can provide~     further benefit in reducing the postoperative major complications and fasten the~     postoperative recovery16. For the most cases, the patients was receiving tri-incision~     esophagectomy, i.e. VATS esophagectomy in the chest, laparoscopic gastric mobilization in the~     abdomen and left cervical esophagogastrostomy. In such circumstances, a cervical incision was~     required for esophagogastrostomy after esophagectomy and gastric mobilization. However, for~     the patients with lower-to mid third esophageal cancer, some surgeon performed Ivor Lewis~     esophagectomy, which performing the esophagogastrostomy in the chest after gastric~     mobilization without cervical incision wound. Although both of these procedures have been~     demonstrated to be feasible and safe, there is much debate about the advantage and~     disadvantage of these two approaches. For tri-incision esophagectomy, patients have the~     chance to have cervical lymph node dissection and the esophagus can be resected up to the~     neck. However, it is more time-consuming and associated with more surgical trauma by adding a~     cervical incisional wound and more tissue dissection around the cervical trachea as compared~     to that done by Ivor Lewis esophagectomy. In contrast, for the Ivor Lewis esophagectomy, the~     resection of esophagus was limited to the level of thoracic inlet and cervical lymph node~     dissection was impossible unless a neck incision was further created. However, it takes less~     time in performing the whole procedure by saving a neck incision.~   "
118461|NCT02016989|"~     The purpose of this study is to evaluate efficiency of CACICOL20 for bacterial keratitis. It~     is a double blinded comparison of epithelial defect in two groups of patients randomized~     between CACICOL20 and physiological salt solution.~   "
118462|NCT02016976|"~     The investigators believe that the local anesthetic EMLA (Lidocaine 2.5% and Prilocaine 2.5%)~     cream will lessen pain and reduce the need for anesthesia and analgesia, when implanting a~     permanent pacemaker.~   "
118496|NCT02016534|"~     This is a multi-centre Phase 2 study. The study will evaluate the activity and safety of AMG~     337 in patients who have MET amplified gastric, gastroesophageal junction or esophageal~     adenocarcinoma or other MET amplified solid tumors. The study is designed to estimate the~     objective response rate of AMG 337 by tumor type.~   "
118463|NCT02016963|"~     This is an open-label study to evaluate the immunogenicity and safety of raxibacumab in~     healthy adult male and female subjects. Subjects who have received raxibacumab >= 4 months~     ago will be enrolled and dosed as follows: A maximum of 25 subjects (to include 3 evaluable~     female subjects) will receive a second dose of raxibacumab equal to that of the previous dose~     >= 4 months following the first dose. Subjects will remain in house from Day 0 until Day 1~     and will be followed for 70 days after receiving the second dose of raxibacumab. Raxibacumab~     has been shown to provide improved survival in rabbit and monkey anthrax spore challenge~     studies. Preliminary data from our rabbit pivotal efficacy study showed significant survival~     benefit for raxibacumab over placebo. Exposure to anthrax and resulting clinical disease can~     occur more than once, especially in individuals who do not develop protective immunity.~     Hence, if clinically indicated for the treatment of anthrax, there may be a requirement for~     the repeat administration of raxibacumab. The rationale of the study is to evaluate the~     immunogenicity and safety of repeat administration of raxibacumab with a >= 4 month interval~     between dosing.~   "
118464|NCT02016950|"~     Investigators seek to observe the long term patterns of arrhythmias detected by permanent~     pacemakers.~   "
118465|NCT02016937|"~     In our study we aimed to compare the lactation process by mothers who were undergoing~     elective Caesarian section under general anesthesia, spinal anesthesia, epidural anesthesia~     and normal vaginal birth.~   "
118466|NCT02016924|"~     The primary objectives of this study are to evaluate the steady-state pharmacokinetics (PK)~     and confirm the dose of cobicistat-boosted atazanavir (ATV/co) or cobicistat-boosted~     darunavir (DRV/co) in HIV-1 infected antiretroviral treatment-experienced, virologically~     suppressed, pediatric participants between the ages of 3 months to < 18 years of age.~      This study will also evaluate the safety, tolerability, and efficacy of ATV/co or DRV/co each~     co-administered with a background regimen (BR) through 48 weeks and during the 5 year~     long-term treatment.~      There will be 2 parts to the study.~        -  Part A: Participants will be enrolled sequentially by age cohort to evaluate the steady~          state PK and confirm dose of ATV/co and DRV/co. Following screening, enrolled~          participants will continue their suppressive regimen of either ATV/r or DRV/r once-daily~          plus their BR. On Day 1, participants will discontinue ritonavir and initiate once daily~          cobicistat (COBI) to be taken with their ATV or DRV plus their BR. All participants~          enrolled in Part A will participate in an intensive PK evaluation of COBI and ATV or DRV~          on Day 10. Following completion of the intensive PK visit, participants will continue to~          receive COBI coadministered with DRV or ATV each with a BR and return for scheduled~          study visits.~        -  Part B: Participants will be enrolled to evaluate the safety, tolerability, and efficacy~          of the ATV/co or DRV/co regimen. For all cohorts in Part B, participants will be~          screened and initiated sequentially by each age cohort following confirmation of~          appropriate COBI exposure and PI exposures from the corresponding age cohort in Part A.~   "
118467|NCT02016911|"~     This trial is conducted in Europe. The aim of the trial is to investigate the~     pharmacokinetics (the exposure of the trial drug in the body), safety and tolerability of~     oral semaglutide (NNC0113-0217) in subjects with mild, moderate and severe degrees of hepatic~     impairment compared to subjects with normal hepatic function.~   "
118468|NCT02016898|"~     The primary focus of this study is to assess intraocular pressure and complication rates~     between patients who receive mitomycin-C using a sponge versus no-sponge.~   "
118469|NCT02016885|"~     The purpose of this study is to evaluate the safety and efficacy of DRM04B compared to~     vehicle for the treatment of axillary hyperhidrosis.~   "
118470|NCT02016872|"~     The purpose of this study is to help researchers investigate if a new imaging agent named~     18F-FMISO can predict if patients with lung cancer will respond to standard therapy, as well~     as whether disease will reoccur in the future. The study will also investigate whether a~     18F-FDG PET scan in the middle of radiation treatment can predict if lung cancer will respond~     to standard therapy. Information obtained from this study may help doctors design future~     studies in which they may target tumor areas that do not respond to therapy or may likely~     reoccur in the future.~   "
118471|NCT02016859|"~     Immature Platelet Fraction (IPF) is a new value in CBC blood tests Recent Studies showed that~     this value may be another prognostic factor in critically ill patients such as those admitted~     to ICU, or those with neutropenic Fever.~      The purpose of the study is to check if the IPF may be used as a prognostic Factor in these~     patients~   "
118472|NCT02016846|"~     Glucocorticoids therapy exposes the patient to an increased risk for diabetes morbidity.~     However, there is no proven preventive therapy. GLP-1-RA has shown to improve glucose~     metabolism in healthy volunteers treated with glucocorticoids. We assume that GLP-1-RA will~     improve glucose metabolism in patients with high risk for diabetes morbidity, treated with~     glucocorticoids.~   "
118473|NCT02016833|"~     This study is a clinical study aiming at establishing immunological assays for the~     qualitative and quantitative evaluation of WT-1, Survivin and HPV16 E7-specific immune~     responses in cancer patients. Such a study will allow the development of suitable~     immunological tools to be used in assessing response in a subsequent phase I study aiming at~     evaluating therapeutic vaccine candidates targeting WT-1, Survivin and/or HPV16 E7-expressing~     tumors. In addition, this study will help defining the baseline cancer-associated immune~     responses in the selected patient population.~      Cervical and ovarian cancer patients, as well as leukemia patients, will be included in this~     study.~      WT-1, Survivin and HPV-specific immune responses will be monitored in these patients by ex~     vivo and cultured IFNg ELISpot as well as tetramer staining.~   "
118474|NCT02016820|"~     The colonic microbiome is essential in health and disease, and is highly dynamic during the~     first several years of life. Proton pump inhibitors (PPIs) and histamine-2 receptor~     antagonists (H2RAs) are widely used in children, but the effects of PPIs and H2RAs on the~     pediatric colonic microbiome are unknown. This study will determine whether acid suppression~     with these medications affects the microbiome of otherwise healthy children who are~     prescribed acid suppression for gastroesophageal reflux disease (GERD), and determine the~     duration and magnitude of microbiome changes.~   "
118525|NCT02016157|"~     In this Randomized clinical trial locally delivered moxifloxacin in situ gel was evaluated as~     an adjunct to scaling and root planing for efficacy in the treatment of chronic periodontitis~     and for short-term effects on the periodontal microflora.~   "
118484|NCT02016690|"~     This post marketing observational study (PMOS) was conducted in Japan during the 2013-2014~     and 2014-2015 Respiratory Syncytial Virus (RSV) seasons to assess the safety and~     effectiveness of palivizumab for the prevention of serious lower respiratory tract infection~     caused by RSV in participants 24 months of age and under, who have an immunocompromised~     medical condition (e.g., combined immunodeficiency disease, antibody deficiency, or other~     types of immunodeficiency; HIV infection; recovering from organ or bone marrow~     transplantation; on chemotherapy; on high-dose corticosteroid therapy; on immunosuppressants)~     or who have Down syndrome.~   "
118485|NCT02016677|"~     The purpose of the study is to collect data regarding the aesthetic outcomes of patients who~     had breast reduction surgery and /or mastopexy in terms such as scaring, patient~     satisfaction, breast ptosis assessment including taking photographs and filling~     questionnaires.~   "
118486|NCT02016664|"~     Oral ketamine is increasingly used by doctors to both reduce the amount of narcotic pain~     medication consumed and to improve chronic pain management in difficult cases. How much is~     absorbed when taken orally, as opposed to intravenously ,is unknown. Ketamine may cause~     sedation, and occasionally cognitive impairment. Therefore, there are safety concerns~     associated with its usage as an out-patient may engage in activities where cognitive~     impairment is dangerous,such as driving. This study is designed to measure the plasma~     concentrations of ketamine and its active metabolite, norketamine, in people taking low dose~     oral ketamine for chronic pain. The goal of the study is to verify that low dose oral~     ketamine produces plasma concentrations below the level associated with toxic symptoms,and~     thus can be safely used long-term for the treatment of chronic pain .~   "
118487|NCT02016651|"~     Gastro-esophageal reflux and aspiration is a common problem in premature infants receiving~     mechanical ventilation. Pepsin measured in tracheal aspirate (TA) emerged as a specific~     marker for aspiration. The objective of this study is to examine if TA pepsin will change~     when ventilated premature infants are positioned in two different positions; on their back~     vs. on their right side.~   "
118488|NCT02016638|"~     Hypothesis:Sleep Disorders are very common during pregnancy but the their exact role in~     causation of pregnancy related disorders is yet to be determined. OSA can complicate~     pregnancy given the risk factors of weight gain, upper displacement of the diaphragm, and~     hormonal-induced hyperaemia of the nasopharyngeal passages. SDB confers the risk of~     hypertensive disorders of pregnancy and is associated with adverse maternal and foetal~     outcomes.~      The study would involve pregnant females which would be prospectively followed in pregnancy~     and post partum to know the prevalence of sleep disorders in pregnancy. Diagnosis of sleep~     disorders would be confirmed by overnight polysomnography and ambulatory blood pressure~     monitoring. Pregnancy outcomes, both maternal and fetal would be recorded and its relation~     with sleep disorders in pregnancy would be analysed.~   "
118489|NCT02016625|"~     The primary objective of this trial is to investigate the effect of multiple-dose faldaprevir~     (FDV) on the single-dose pharmacokinetics of cyclosporine or tacrolimus~   "
118490|NCT02016612|"~     Will the use of an FDA approved highly purified silk scaffold; Seri Surgical Scaffold help~     shape and hold the breast up on the chest preventing re-stretching and bottoming out of the~     breast in breast reduction or augmentation-mastopexy patients? The amount of stretch will be~     measured manually as well as percent of breast tissue measured with the Canfield Vectra 3-D~     Imaging system reporting the amount of breast tissue above and below the nipple level.~   "
118491|NCT02016599|"~     Prematurity is a very important problem in this country. Prematurity can cause problems with~     organ (such as the brain, heart, kidneys) growth and development. A very important part of~     keeping premature babies healthy is ensuring good blood flow to all of these organs.~      Some premature babies have problems with their hearts and getting enough blood out to the~     rest of their bodies. This problem is referred to as hypotension (low blood pressure) and is~     found by looking at blood test values and while examining the baby. These babies will need~     medications to help their heart deliver blood to all of the important areas in their bodies.~      Babies who have hypotension requiring medications tend to have more problems than premature~     babies that don't need hypotension medication. Some of these problems include a higher risk~     of bleeding into their brain, kidney problems, liver problems, intestinal (gut) problems~     causing difficulty tolerating feeds, and a very dangerous infection of their intestines. Some~     long term effects include hearing loss, developmental delay, and learning problems in the~     future that are worse than other premature babies who did not have hypotension. Hypotensive~     premature babies also have a higher risk of death.~      The cause of hypotension in the first week of life is still not known. We know that babies~     have to get used to being in the outside world instead of in the womb. A lot of changes with~     the heart and lungs have to happen for them to not be affected by that transition. If we~     could gain a better understanding of those changes, we might be able to prevent some of these~     issues from happening.~      This study will look closely at premature babies with and without hypotension to assess the~     heart and lung changes in the first week of life. To do this, we will use monitoring machines~     and tests to get a better idea of all the changes that happen. This information will help all~     neonatologists who care for premature babies.~   "
118492|NCT02016586|"~     To evaluate the benefits of a lactation support intervention, in conjunction with maternal~     nutritional supplementation.~   "
118493|NCT02016573|"~     This is a study investigating the safety and usefulness of the Renal Denervation Procedure in~     reducing high blood pressure in people whose blood pressure is not adequately controlled~     despite already being treated with 2 blood pressure lowering drugs. This study is designed to~     compare the effects renal denervation to a usual care group.~   "
118494|NCT02016560|"~     This is a cross-sectional and longitudinal study that will evaluate imaging characteristics~     of 18F-AV-1451 in cognitively healthy volunteers, mild cognitive impairment (MCI) and~     Alzheimer's disease (AD) subjects.~   "
118495|NCT02016547|"~     Intravenous (IV) Alteplase (rt-PA) is the gold standard for brain infarction within 4 h 30 of~     symptoms onset. Efficacy of this therapy is limited in the setting of large artery~     occlusions. For middle cerebral artery occlusions (MCA)or internal carotid artery occlusions~     (ICA), recanalization rates will drop as low as 10%. This element is critical as prognosis is~     linked to recanalization. Arterial re-occlusions are frequent and may reach 30%, which limits~     IV thrombolysis efficacy.With the endovascular approach, recanalization rates may reach 90%~     with last generation devices. A recent meta-analysis has shown that the best candidates for~     thrombectomy are MCA occlusions. In the coronary literature, endovascular therapy efficacy is~     increased in association with antiplatelets such as abciximab. The aim of the study was to~     assess the feasibility of thrombectomy associated with abciximab on revascularisation (TICI~     score), as well as safety (symptomatic intracranial bleeding), in order to design a clinical~     trial versus the gold standard for acute ischemic stroke revascularization strategies using~     IV rt-PA.This is a controlled, pilot study, evaluating feasibility and safety of thrombectomy~     with abciximab versus IV rt-PA in acute ischemic stroke patients within 4h30 of symptoms~     onset.~   "
118526|NCT02016144|"~     This study is intended to find the optimal length of pre-inserted ETT for nasal fiberoptic~     intubation and the equation to predict it.~   "
118497|NCT02016521|"~     In humans, the primary means of cooling the body during exercise is through the evaporation~     of sweat from the skin surface. Clothing represents a layer of insulation that hinders the~     evaporation of sweat from the surface of the skin. It follows that clothing that imposes the~     least amount of resistance to evaporative heat loss may prove beneficial to the~     thermoregulatory, physiological and perceptual response to exercise, particularly in elite~     endurance-trained athletes. Thus, the purpose on this study is to examine the influence of~     wearing a sportswear garment made of a fabric (100% nylon) with superior evaporative~     characteristics on detailed thermoregulatory, cardiorespiratory, metabolic and perceptual~     responses to maximal exercise testing at normal room temperature and relatively humidity in a~     group of 25 endurance-trained cyclists and triathletes aged 20-60 years. It is hypothesized~     that wearing a garment made of 100% nylon will improve exercise performance (e.g., exercise~     endurance time) and that this improvement will reflect improvements in thermoregulatory,~     cardiorespiratory, metabolic and perceptual responses to exercise. Athletes will be recruited~     via contact with coaches of the McGill University Cycling and Triathlon teams as well as~     through contact with coaches of competitive cycling and triathlon teams/training groups in~     the Montreal and surrounding area. Initial contact will consist of a thorough explanation of~     the study procedures and pre-screening for the inclusion/exclusion criteria prior to study~     consent by the Principal Investigator and/or his delegate, either in person or by telephone~     or email. Eligible participants will visit McGill's Clinical Exercise & Respiratory~     Physiology Laboratory on 3 separate occasions over a period of 10-14 days. Visit 1 will~     include a maximal incremental bicycle exercise test for familiarization purposes and to~     determine maximal power output (MPO). Visits 2 and 3 will include a constant-power-output~     bicycle exercise test at 85% MPO under one of two conditions, in randomized order: (1) while~     wearing a garment made of 100% polyester, i.e., placebo; and (2) while wearing a garment made~     of 100% nylon, i.e., cooling fabric. At rest and during exercise at visits 2 and 3, detailed~     assessments of core body temperature will be made using a temperature sensor placed into the~     esophagus, while skin temperature and other physiological and perceptual parameters will be~     measured using standard techniques.~   "
118498|NCT02016508|"~     The purpose of this Phase I/II study is to investigate the safety and preliminary efficacy of~     unilateral intravitreally transplantation of adult bone marrow stem cells in subjects with~     geographic atrophy secondary to age-related macular degeneration.~   "
118499|NCT02016495|"~     To evaluate whether a combined supplementation of magnesium and lipoic acid is able to~     significantly reduce the incidence of uterine contractions and related episodes of~     hospitalization in pregnant women.~   "
118500|NCT02016482|"~     This study is being conducted to assess the safety and efficacy of adalimumab in participants~     with nail psoriasis.~   "
118501|NCT02016469|"~     The purpose of this study is to evaluate the effect and safety of pectin and fecal microbiota~     transplantation on patients with inflammatory bowel disease. The investigators hypothesize~     that patients who take pectin can promote the migration of probiotics in intestine~     engraftment, reduce pathogenic agents'adhesion to intestinal mucosa, cut down the~     inflammation, and to maintain intestinal flora diversity and steady state in a long time.~   "
118502|NCT02016456|"~     This research programme purports to test the effectiveness of two Transcranial Magnetic~     Stimulation (TMS) protocols (Repetitive high frequency protocol and Theta Burst protocol) in~     reducing the symptoms of depression. The study also uses Magnetic Resonance Imaging (MRI)~     scans to improve the localization of TMS targets.~   "
118503|NCT02016443|"~     Herniorrhaphy is the most frequent general surgical procedure. There are moderate pain~     complaints after herniorrhaphy. Besides causing discomfort to the patients, pain, can delay~     recovery and discharge and cause cognitive dysfunction and difficulty with returning to~     normal daily activity.~      A combination of analgesics with different effect sites can reduce the doses needed and~     analgesic related side effects which is called multimodal analgesia .~      Opioids, acetaminophen, nonsteroid anti-inflammatory drugs and cox-2 inhibitors, alfa-2~     receptor agonists, steroids, gabapentin and pregabalin have been used for this purpose(4).~      Tizanidine is an alfa-2 receptor agonist, and is used for musculoskeletal pain conditions.~     Tizanidine reduced the local anesthetic requirement in spinal anesthesia.~      The aim of this study is to investigate the hypothesis that: Tizanidine can reduce the pain~     scores, analgesic consumption, analgesic related side effects and provide early return to~     normal daily activity compared to placebo after inguinal herniorrhaphy.~   "
118504|NCT02016430|"~     Our group has recently identified the association between gut-flora-mediated carnitine and~     phosphatidylcholine metabolism, specifically trimethylamine-N-oxide (TMAO), and~     cardiovascular risk. This study investigates the ability for dietary intervention to modulate~     TMAO levels.~   "
118505|NCT02016417|"~     The present study is a randomized, control, phase II study of locally advanced nasopharyngeal~     carcinoma (NPC) treated with Gemcitabine plus cisplatin regimen (GP) or Docetaxel，cisplatin~     regimen plus 5-Fluorouracil (TPF) induction chemotherapy followed by concurrent~     chemoradiotherapy.~   "
118506|NCT02016404|"~     The purpose of this study was to investigate the effects of low-sodium, high-potassium~     condiments and salt on blood pressure in untreated (pre)hypertensive Vietnamese adults.~   "
118507|NCT02016391|"~     The purpose of he study is to evaluate effects of dexmedetomidine on pain during~     radiofrequency ablation of liver and kidney tumours.~   "
118508|NCT02016378|"~     This study investigates the effect of a computerized approach/avoidance retraining (aka~     cognitive bias modification) over and above treatment as usual for patients in treatment for~     substance use disorders. The computerized training entails viewing pictures of drug and~     non-drug related stimuli, and then using the computer to make the drug pictures smaller and~     the non-drug pictures larger. Participants will also take part in an EEG/event-related brain~     potential assessment at the beginning and end of treatment to identify brain measures that~     are associated with treatment response.~   "
118509|NCT02016365|"~     The primary objective for this study is to evaluate the efficacy of doxycycline +~     ursodeoxycholic acid (UDCA) on disease progression in Transthyretin Amyloidosis (ATTR)~     subjects with cardiomyopathy with or without neuropathy.~   "
118510|NCT02016352|"~     PROLIPHYC is a collaborative prospective study that aims at discovering deep cerebrospinal~     fluid (CSF) proteome with a new clinically-compatible proteomics strategy, in a cohort of 100~     patients suspected of neurodegenerative diseases and/or normal pressure hydrocephalus.~   "
118511|NCT02016339|"~     The purpose of this study was to compare the effects on sleepiness, quality of life,~     depression, hospitalization and deaths rate, of intensive vs standard interventions, on CPAP~     adherence, 2 years after CPAP initiation.~   "
118545|NCT02015897|"~     The objective of this study is to investigate if Complete Decongestive Therapy is equally~     effective whether it includes manual lymphatic drainage or not in the treatment of~     lymphoedema among patients with breast cancer.~   "
118563|NCT02015663|"~     To provide efficacy and safety data comparing two dosing schedules of Tobramycin Inhalation~     Powder (TIP) for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic~     fibrosis.~   "
118512|NCT02016326|"~     The purpose of this study is to assess whether the use of I-Scan during colonoscopy leads to~     an increased yield of adenomas in the colon among a population at increased risk for CRC.~      Primary Outcome:~      Adenoma Detection Rate (ADR — No. of colonoscopies at which one or more histologically~     confirmed adenomas were found divided by the total no. of colonoscopies performed in the same~     time period) in the right colon using High Definition White Light Colonoscopy Versus I-Scan~     enhanced Colonoscopy.~      Secondary Outcomes:~        -  Adenoma Detection Rate (ADR) of High Definition White Light Colonoscopy Versus I-Scan~          colonoscopy through out the entire colon.~        -  Adenoma Detection Rate (ADR) in the right colon during the Second look, irrespective~          of imaging modality.~        -  Polyp Detection Rate (PDR - No. of colonoscopies at which one or more polyps were~          found(regardless of the histological type) divided by the total no. of colonoscopies~          performed in the Same time period) for each arm of the study in Right colon and~          throughout the entire colon.~        -  Mean number of adenomas per procedure for each arm of the study in right colon and~          throughout the entire colon.~        -  Mean number of polyps per procedure for each arm of the study in right colon and~          throughout the entire colon.~        -  Number of neoplastic lesions for each arm of the study in the right colon and throughout~          the entire colon and number of neoplastic lesions missed on 1st pass of right colon.~        -  Proportion of patients with diminutive lesions (< 5 mm) in each arm of the study~        -  Proportion of patients with Flat lesions (height < 1/2 diameter) in each arm of the~          study~        -  Proportion of patients with Sessile Serrated Adenoma in each arm of the study~        -  Proportion of patients with invasive cancer in each arm of the study~        -  Presence or absence of learning effect while using this technology given that use of~          I-Scan may train the human eye to better identify adenomas even without image~          enhancement.~   "
118513|NCT02016313|"~     The purpose of this study is to determine whether physiotherapy is effective in the treatment~     of a group of tinnitus patients with neck complaints.~   "
118514|NCT02016300|"~     The study will examine clinical and radiographic outcomes of microfracture surgery (a common~     technique to address isolated areas of cartilage loss) in the knee used with or without~     unloader bracing. Randomly selected patients will wear an unloader brace, which is designed~     to take pressure off the area of the knee which underwent repair, for several weeks after~     surgery. Our hypothesis is that bracing may improve clinical and or radiographic outcomes.~      The surgery performed will be the same for all patients~      The length of follow up and schedule of post-operative MRI will be the same for all patients.~      The only difference in groups will be presence of absence of brace wear.~   "
118515|NCT02016287|"~     Elderly patients with metastatic esophageal squamous cell carcinomas have poor prognosis and~     majority of them were intolerable to combined chemotherapy in China. In the investigators~     phase II clinical trial proceeded before, the paclitaxel treatment showed good tolerance and~     efficacy to esophageal squamous cell carcinomas. Radiotherapy has been indicated as a~     definitive treatment for unresectable or medically inoperable tumors in ESCC patients.~     However, not only the combination with chemotherapy, but also the boundaries of the clinical~     target volume (CTV) are not internationally defined. The investigators then initiated a~     prospective phase II clinical trial with sequential paclitaxel/cisplatin and radiotherapy as~     the 1st line treatment in elderly metastatic esophageal carcinoma to observe the efficacy and~     safety of the combination.~   "
118516|NCT02016274|"~     Metastatic esophageal squamous cell carcinomas have poor prognosis and majority of patients~     resistant to chemotherapy in China. In the investigators phase II clinical trial proceeded~     before, the combination of paclitaxel with cisplatin showed good tolerance and efficacy to~     esophageal squamous cell carcinomas. Radiotherapy has been indicated as a definitive~     treatment for unresectable or medically inoperable tumors in ESCC patients. However, not only~     the combination with chemotherapy, but also the boundaries of the clinical target volume~     (CTV) are not internationally defined. The investigators then initiated a prospective phase~     II clinical trial with sequential paclitaxel/cisplatin and radiotherapy as the 1st line~     treatment in metastatic esophageal carcinoma to observe the efficacy and safety of the~     combination.~   "
118517|NCT02016261|"~     Open label, non-comparative, prospective study to evaluate cognitive functioning in remitted~     depression outpatients during long-term preventive treatment with Fluvoxamine (Fevarin®)~   "
118518|NCT02016248|"~     The purpose of this study is to determine the side effects and how effective CyberKnife~     stereotactic ablative body radiation (SABR) is in patients with prostate cancer. The~     CyberKnife system is a new type of radiation machine that uses a special system to precisely~     focus large doses of x-rays on the tumor. The device is designed to concentrate large doses~     of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be~     minimal. The purpose of this evaluation is to see if this treatment will help patients with~     your condition and to evaluate the effect of this treatment on your quality of life over~     time.~   "
118519|NCT02016235|"~     Patients with Dent disease have suppressed levels of FGF 23 which contributes to~     hypercalciuria, kidney stones, nephrocalcinosis and renal failure. Supplementation with~     phosphorus may reduce hypercalciuria.~   "
118520|NCT02016222|"~     In the primary progressive multiple sclerosis, the detection of oligoclonal bands in~     cerebrospinal fluid is critical for the diagnosis. However, lumbar puncture for cerebrospinal~     fluid collection is considered relatively invasive. Our hypothesis is that oligoclonal bands~     detection in tears is possible and useful for the diagnosis of multiple sclerosis.~   "
118521|NCT02016209|"~     platinum-based albumin-bound paclitaxel regimen in advanced non-small cell lung cancer~     (NSCLC) especially in lung squamous cell carcinoma has a better tumor response rate and~     safety than solvent-based paclitaxel.However, the safety and efficacy is uncertain in~     neoadjuvant therapy.~   "
118522|NCT02016196|"~     TIPS has been used for 20 years, as a means of reducing portal pressure in patients with~     cirrhosis and portal hypertension related complications. TIPS proved more effective than~     alternative treatments in controlling or preventing variceal bleeding and refractory ascites.~     The main drawback of the TIPS procedure is progressive overt hepatic encephalopathy (OHE).~     Three risk factors for post-TIPS OHE have been identified: age over 65 years, history of~     previous episodes of OHE, and Child-Pugh score equal to or over 10. However, the incidence of~     post-TIPS OHE in patients fulfilling these criteria remains close to 35 %.~   "
118523|NCT02016183|"~     To evaluate the safety and efficacy of long-term use of candesartan cilexetil /~     hydrochlorothiazide combination tablets (ECARD) Combination Tablets LD&HD in hypertensive~     patients in the routine clinical setting~   "
118524|NCT02016170|"~     Recently, two new oral P2Y12 antagonists have been approved for clinical use: prasugrel, a~     third generation thienopyridine, and ticagrelor, a first in class~     cyclopentyltriazolopyrimidine (CPTP). These agents have been shown to be associated with more~     potent platelet inhibitory effects compared with clopidogrel. In addition, both agents have~     shown to be superior to clopidogrel in preventing recurrent ischemic events in the setting of~     acute coronary syndromes (ACS). Understanding how to switch patients from prasugrel to~     ticagrelor is an unmet need of clinical interest. The proposed PD investigation will have a~     prospective, randomized, parallel design aimed to show that switching patients from prasugrel~     to ticagrelor provides similar levels of platelet inhibition.~   "
118628|NCT02014805|"~     The purpose of this study is to determine whether postoperative conformal radiotherapy are~     effective in the treatment of Masaoka stage II-III B type thymoma.~   "
118527|NCT02016131|"~     Re-hospitalization or re-intervention is sometimes necessary to treat type I and type III~     endoleaks after EVAR for its persistent increasing of pressure in aneurysm lumen. Color-coded~     quantitative digital subtraction angiography (CQDSA) provides an easy and quick way to~     post-process the traditional digital subtraction angiography (DSA) which converts the peak~     time of the maximal contrast medium intensity into a single polychromatic image. With the~     help of CQDSA, a quantitative evaluation of the endoleak hemodynamics and a risk analysis of~     the type I or type III endoleak could be performed during the EVAR procedure. This approach~     may offer an objective assessment of the needs for immediate re-intervention, conservative~     therapy or treatment endpoint in the future.~   "
118528|NCT02016118|"~     The purpose of this study is to assess the effectiveness and costs associated with the~     intravesical administration of combined hyaluronic acid (HA) and chondroitin sulphate (CS)~     compared to the current standard management of recurrent urinary tract infections in adult~     women diagnosed with recurrent urinary tract infections (RUTI).~   "
118529|NCT02016105|"~     The aim of the study is to demonstrate equivalent efficacy and similarity in the safety~     profile of GP2017 and Humira® in patients with moderate to severe chronic plaque-type~     psoriasis.~   "
118530|NCT02016092|"~     There are approximately one million Americans who live with Parkinson's disease with 50,000~     new cases per year and this rate is expected to rise with an aging population. The underlying~     pathophysiology and disease understanding of PD still remains elusive due to a combination of~     disease complexity and lack of predictive capability of existing models.~      The Berg Interrogative Biology™ discovery platform has demonstrated a unique capability in~     producing drug targets and biomarkers that truly represent a disease phenotype. It has been~     able to catalyze molecules now in late stage clinical trials in cancer and many pre-clinical~     candidate therapeutics and biomarkers in endocrinology and central nervous system (CNS)~     diseases. The platform is able to decipher normal versus disease signatures by integration of~     data sets from the genome, metabolome, proteome, and lipidome in an agnostic manner that is~     subjected to Bayesian Artificial Intelligence informatics. The resulting nodes are then put~     back into wet-lab validation before proceeding to proof-of-principle pre-clinical testing.~      By utilizing clinical data and specimens obtained by the medical specialists at The~     Parkinson's Institute, along with Berg's Interrogative Biology™, this study aims to discover~     a disease biomarker enabling the creation of a diagnostic test for Parkinson's disease.~   "
118531|NCT02016079|"~     The primary purpose of this study was to assess the effectiveness of omega-3 supplementation~     on behavior problems in children.~   "
118532|NCT02016066|"~     The purpose of the study is to assess the safety, pharmacokinetics (what the body does to the~     drug) and immunogenicity (ability of a particular substance to provoke an immune response in~     the human body) of CR6261 in Japanese healthy participants~   "
118533|NCT02016053|"~     500 patients with normal renal function will be prospectively studied and incidence, spectrum~     and natural history of AKI (Acute Kidney Injury) will be observed in them and in 200 patients~     with abnormal renal function fulfilling AKI (Acute Kidney Injury) criteria will be~     prospectively studied for 1 year. Also biomarkers will be studied and validated as early~     predictors of AKI (Acute Kidney Injury).~   "
118534|NCT02016040|"~     To evaluate the rate of patients without cancer detected by biopsies performed six months~     after hemi-ablation with high intensity focused ultrasound (HIFU) (Ablatherm ®).~      Evaluate the impact of the HIFU treatment on continence, sexuality and quality of life at one~     year. Evaluate the cost of hemi-ablation HIFU treatment.~      A prospective single -centre phase II, single arm, cohort study (therapeutic confirmatory)~     offering focal therapy using HIFU (Ablatherm ®) to 25 men with histologically proven~     localised low to intermediate risk prostate cancer (PSA ≤10ng/ml, Gleason score ≤ 7 ,T1c or~     T2b ). Precise mapping and characterisation of the disease will be established using~     multi-parametric (mp)-MRI and prostate biopsies. Only the lobe with disease will be treated.~   "
118535|NCT02016027|"~     AIMS & OBJECTIVES To evaluate the effectiveness of administering of Carica folia mother~     tincture to healthy individual's Platelet count.~      Sample Details:- Students, Doctors and non-teaching staffs of Father Muller Homoeopathic~     Medical College are taken up for the study. A minimum of 60 persons will be selected and will~     be divided into two groups, Control & Experiment by lottery method.~      Voluntary participation in the study is expected. 30 persons in each group. One group will~     receive Carica folia mother tincture and other group will receive placebo.~      Complete Blood count including platelet count will be measured for all 60 subjects before~     commencing the study.~      The drug namely Carica Folia mother tincture will be procured from Father Muller Homoeopathic~     Pharmaceutical Division which compiles with the standards of Homoeopathic Pharmacopeia of~     India.~      Daily dosage -30 drops of Carica Folia mother tincture in 30 ml of distilled water morning~     and night for 3days.~      On 4th day complete blood count including platelet count will be estimated for all 60~     subjects.~      Research Methodology and Statistics:~      Pre &Post with Control Design is done. Data from the sample is collected and is subjected to~     Paired 't' test and unpaired 't' test.~      HYPOTHESIS:-~      Null hypothesis:~      No significant changes in complete blood count and platelet count before and after the~     intervention.~      Alternate hypothesis:~      There is significant variation in complete blood count and platelet count before and the~     intervention.~   "
118546|NCT02015884|"~     At the hospital, the attacks against health professionals are becoming commonplace, making~     working conditions difficult. The ophthalmological emergencies are a perfect testing ground~     to evaluate the effectiveness of a series of original actions to prevent the occurrence of~     violence against healthcare workers. The main objective is to measure the impact of an~     integrated prevention of the occurrence of antisocial behavior or attacks against the~     healthcare workers.~      The prevention program combines five interventions (steps): 1) a computer sorting algorithm~     and specific screens for calling patients in waiting rooms, 2) a clear signage to direct~     patients between waiting rooms, treatment rooms and administrative et medical offices, 3)~     Posts information on the activity of emergency services displayed on screens, in the waiting~     rooms, 4) a mediator/go-between/conciliator, 5) and a dummy surveillance camera.~      This is an interrupted time series study. All patients admitted to the ophthalmological~     emergency unit of a university hospital located in Lyon, France, are included in the study,~     from June 2013 to Sept 2015~   "
118536|NCT02016014|"~     Objectives: To develop and validate a mobile tool for use in Smartphone supports as a first~     step, and to evaluate the effect of adding this new tool of information and communication~     technologies (ICT), to a standardized intervention to increase adherence to nutritional~     recommendations of the Mediterranean diet and increase physical activity as primary endpoint.~     Analyze adherence and intervention results from a gender perspective. Methodology:~     Multicenter, randomized double-blind, clinical trial with two parallel group, aimed at~     assessing the effects of adding an TIC tool, developed for the Smartphone application~     (intervention), in support of behavioral and educational recommendations (control) in the~     increased physical activity and adaptation to the Mediterranean dietary pattern. Population:~     1215 included subjects younger than 70 years from the project EVIDENT who agree to~     participate. Measurement and interventions: Physical activity will be assessed with the~     accelerometer and the 7-PAR day and adaptation to the Mediterranean diet with a questionnaire~     of adherence and a food frequency survey. It will also assess vascular structure and~     function, central blood pressure, Augmentation index, pulse rate and of carotid intima-media~     thickness. The counsel to adaptation the Mediterranean diet (based on the project PREDIMED)~     and exercise (based on PEPAF project), will be common to both groups. The intervention group~     will be added training and use of an application on a Smartphone designed to promote healthy~     eating and increased physical activity.~   "
118537|NCT02016001|"~     to identify the Effective Fluoride Concentration In Toothpaste For Dental Caries Prevention~     after 18 months of randomized controlled trial.~   "
118538|NCT02015988|"~     To test the hypothesis that early (within 5-21 days after index event) administration of~     combined lipid-lowering therapy in extremely high risk population of patients with type 2~     diabetes mellitus (T2DM) and hypertriglyceridemia (HTG) who experienced acute coronary~     syndrome (ACS) will be effective and well tolerated in achievement of contemporary strict~     requirements for triglyceride (TG) levels as an independent risk factor in the case of HTG~     with diabetes.~   "
118539|NCT02015975|"~     Depending on the fracture pattern of patellar fractures tension band wiring, interfragmentary~     screw fixation or combinations are common treatments. But there are several problems~     associated with these techniques as fracture dislocation or loosening and perforation of the~     wire. Furthermore an anatomic reduction with stable fixation in comminuted fractures is~     almost impossible to achieve.~      A new option in the treatment of patellar fractures is the locking plate osteosynthesis,~     which provides a more stable fixation and higher mechanical strength in biomechanical tests~     compared to classic tension band wiring. Due to various screw positioning a stable fixation~     in comminuted fractures can be achieved and an early functional treatment with full weight~     bearing reduces the loss of knee-motion. Furthermore a removal of the osteosynthesis seems~     not to be essential anymore and the blood supply is not to be compromised.~      Because of the absent of clinical evidence investigators want to evaluate the clinical~     outcome after locking plate osteosyntheses in patellar fractures and compare patient~     satisfaction, functional motion, complications and number of revisions with common~     treatments.~   "
118540|NCT02015962|"~     Null hypothesis: There is no difference in the efficacy of IVPR and EPR during an episode of~     hypokalemia.~      Alternate Hypothesis: There is a mean difference of 15% in Serum Potassium levels between the~     two groups.~      Objective: To compare the efficacy EPR and IVPR for treatment of hypokalemia (measured as~     change in serum potassium levels in milliequivalent/L after potassium replacement)~   "
118541|NCT02015949|"~     Traumatic brain injury (TBI) is the most common cause of death and disability in young~     adults. Patients can experience significant problems with concentration, attention, and~     memory (so called 'cognitive impairments') following TBI. These cognitive impairments can~     drastically impact on a patient's well-being, and can lead to significant economic and social~     consequences. Roughly a quarter of TBI patients improve but an equal number deteriorate over~     time. The investigators know little about why patients vary so much in how they recover.~     Crucially, the investigators have no treatments to improve brain functioning or recovery~     after TBI.~      Trials investigating ways of protecting the brain just after injury have been disappointing.~     An alternative strategy, however, is to improve the function of brain regions that remain~     intact, but that function inefficiently after TBI. The investigators know that dopamine (a~     chemical in the brain) is known to influence many brain functions and the investigators know~     that pathways in the brain that use dopamine are affected by TBI.~      In humans, drugs that increase dopamine in the brain, such as methylphenidate, are sometimes~     used to enhance cognitive function after TBI, but the response to treatment can be highly~     variable between patients. Therefore, what is needed in the clinic is a way to target the use~     of these drugs to patients who are likely to respond.~      In a single centre study, the investigators will use SPECT (Single Photon Emission~     Tomography) imaging to measure dopamine levels in the brain. MRI (Magnetic Resonance Imaging)~     scans will assess brain structure and function. The investigators will test whether treatment~     with methylphenidate improves cognitive functions in TBI patients who have ongoing cognitive~     problems, whether the mechanism involves a normalisation of brain functioning and whether~     brain dopamine levels can predict the magnitude of any improvement in symptoms.~   "
118542|NCT02015936|"~     The purpose of this study is to understand if a home-based physical activity program can~     improve symptoms and physical function among patients with advanced stage cancer.~   "
118543|NCT02015923|"~     Main outcome: Assess the impact of cancer-related survival at 2 years in patients with~     unresectable metastatic colorectal cancer treated with chemotherapy alone versus surgery~     followed by chemotherapy. To assess overall survival. To evaluate postoperative morbidity and~     mortality in patients treated with resection of the primary tumor. Assess complications and~     meed for surgery in patients treated with systemic chemotherapy only during the course of the~     disease. Identify and describe the complications related to chemotherapy and toxicity in the~     short and medium term systemic treatment. Assessing the quality of life questionnaire QLQ-C30~     and QLQ-CR29. To study prognostic survival factors.~      Method: multicenter randomized clinical trail (22 hospitals). Two parallel group in which to~     evaluate two therapeutic strategies for colorectal cancer metastasis unresectable stage IV:~     chemotherapy alone versus primary tumor resection plus chemotherapy.~      Subjects: patients with unresectable nonmetastatic colorectal cancer. Hypothesis:Surgical~     resection of the primary tumor in stage IV colorectal patients with unresectable synchronous~     metastases increases by 14% overall survival compared to patients receiving systemic~     treatment with chemotherapy without resection of the primary tumor (survival of 34% vs 20%).~   "
118544|NCT02015910|"~     The primary objective of this study is to compare the rate of healing as well as percent of~     wounds healed in Type II diabetic patients with chronic foot ulcerations receiving~     sitagliptin versus placebo.~      The hypothesis for this study is that subjects receiving daily doses of sitagliptin in~     combination with their regular antihyperglycemic medications will result in increased healing~     rates as well as a greater number of healed wounds as compared to subjects receiving placebo~     and their regular antihyperglycemic medications.~   "
118547|NCT02015871|"~     This trial is an open-label, multi-centre, single arm extension for the 000006 trial in~     Chinese patients with prostate cancer. Eligible patients will receive monthly (28-day~     intervals) maintenance doses of 80 mg (20 mg/mL) degarelix administered by subcutaneous~     (s.c.) injection for a period of 2 years from first visit in this extension trial. Patients,~     who received goserelin treatment in the main trial, will get a degarelix starting dose (240~     mg; 40 mg/mL) at the first visit and continue on degarelix treatment. The purpose of this~     2-year extension trial is to collect long-term safety and tolerability data for the one-month~     dosing regimen.~   "
118548|NCT02015858|"~     Pain evaluation remains a clinical problem. Pain Monitor allows pain evaluation using the~     measurement of skin conductance.~      Withdrawal of chest tube can be painful and the purpose of the study was to compare~     auto-evaluation of pain (visual analogic scale) and the index measured by the Pain Monitor.~   "
118549|NCT02015845|"~     The objective of this study is to evaluate the effectiveness of Accuvein to facilitate~     placement of peripheral intravenous catheters in obese patients. This clinical protocol is~     designed to determine whether using Accuvein increases the ease and efficiency of venous~     cannulation (as perceived by the operator), decreases the time to effective cannulation, and~     decreases the patient's perception of the pain.~   "
118550|NCT02015832|"~     Clinical study that aims to evaluate a new strategy using the SYNTAX II Score calculator in~     the functional assessment of patients with new coronary 3-vessel-disease who undergo~     percutaneous coronary intervention (PCI)~   "
118551|NCT02015819|"~     This phase I trial studies the side effects and determines the best dose of genetically~     modified neural stem cells and flucytosine when given together with leucovorin for treating~     patients with recurrent high-grade gliomas. Neural stem cells can travel to sites of tumor in~     the brain. The neural stem cells that are being used in this study were genetically modified~     express the enzyme cytosine deaminase (CD), which converts the prodrug flucytosine (5-FC)~     into the chemotherapy agent 5-fluorouracil (5-FU). Leucovorin may help 5-FU kill more tumor~     cells. The CD-expressing neural stem cells are administered directly into the brain. After~     giving the neural stem cells a few days to spread out and migrate to tumor cells, research~     participants take a 7 day course of oral 5-FC. (Depending on when a research participant~     enters the study, s/he may also be given leucovorin to take with the 5-FC.) When the 5-FC~     crosses into brain, the neural stem cells convert it into 5-FU, which diffuses out of the~     neural stem cells to preferentially kill rapidly dividing tumor cells while minimizing~     toxicity to healthy tissues. A Rickham catheter, placed at the time of surgery, will be used~     to administer additional doses of NSCs every two weeks, followed each time by a 7 day course~     of oral 5-FC (and possibly leucovorin). This neural stem cell-based anti-cancer strategy may~     be an effective treatment for high-grade gliomas.~      Funding Source - FDA OOPD~   "
118552|NCT02015806|"~     The aim of this study is to determine whether adherence to oral maintenance medications~     differs for patients randomized to receive a RxTimerCap, a Take-N-Slide, a standard pillbox,~     or none of these devices, with the hypothesis that low-touch devices improve adherence over~     control and that the increase in adherence is agnostic across devices.~   "
118553|NCT02015793|"~     The purpose of this study is to investigate the efficacy, safety, and pharmacokinetics of~     adalimumab following subcutaneous (SC) administration of 2 dosing regimens in Chinese~     subjects with Crohn's disease.~   "
118554|NCT02015780|"~     To evaluate the efficacy of fasiglifam 50 mg once daily compared to placebo on glycemic~     control as measured by glycosilated haemoglobin (HbA1c) over a 16-week treatment period in~     participants with Type 2 Diabetes Mellitus (T2DM) and chronic kidney disease (CKD) stage 4 or~     5 on dialysis.~   "
118555|NCT02015767|"~     A patient registry to capture real life data and demonstrate the performance of roflumilast~     (Daxas®) in a standard clinical practice.~   "
118556|NCT02015754|"~     Purpose:~      The purpose of this study is to determine the feasibility and safety of using small beads~     (70-150 micron in place of 100-300 micron) to deliver chemotherapy into the liver to treat~     patients with liver lesions from colorectal cancer. The beads (LC-Bead M1) will be loaded~     with irinotecan (DEBIRI-M1), and used to administer transarterial chemoembolization (TACE).~      Eligibility:~      Patients with liver cancer from colorectal cancer.~      Study Overview/ Treatment:~      DEBIRI, loaded with irinotecan, is a device that utilizes tiny beads (70-150 microns) to~     deliver chemotherapy agents into liver tumor(s) via the hepatic artery. This device allows~     for continuous release of irinotecan into the liver tumor tissue(s) causing necrosis of the~     targeted tumor(s). The potential advantages of the smaller beads are deeper penetration into~     the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and~     more consistent dosing. Response to therapy will be evaluated monthly by clinic visits and~     blood tests (to include assessment of liver function and tumor markers) and by imaging~     (usually MRIs) every 1-2 months. Patients will be on study for 6 months after which they will~     be exited from the study and followed for survival. Once exited from the study they will~     continue to be eligible to receive DEBIRI, should it be recommended.~   "
118557|NCT02015741|"~     The assessment of anesthesia depth was based, until recently, on the evolution of hemodynamic~     parameters. Nowadays it can be evaluated by several monitoring methods, derived from~     electroencephalogram analysis, namely the Bispectral Index (Aspect Medical Systems, Newton,~     USA). A new modality is currently under development: the NeuroSENSE (Cleveland Medical~     Devices Inc., Cleveland, OH 44103, USA).~      Use of such devices is discussed in aged patients. The purpose of this study is to compare~     Bispectral Index and NeuroSENSE during awake periods and during natural sleep.~   "
118558|NCT02015728|"~     This research study is a Feasibility clinical trial. In this trial, researchers are trying to~     figure out whether a medication can be chosen based on rapid testing done on tumor tissue.~     Information from a feasibility or pilot trial will hopefully help researchers plan larger~     trials in the future to determine the effect of this therapy.~   "
118559|NCT02015715|"~     This randomized, double-blind, placebo-controlled, single ascending dose study will assess~     the safety, pharmacokinetics, and pharmacodynamics of RO6864018 in healthy, male, Asian and~     Caucasian participants. Participants will be enrolled in cohorts and randomized 8:2 to~     receive a single oral administration of RO6864018 or placebo. Total study duration for each~     participant is up to 9 weeks.~   "
118564|NCT02015650|"~     Concomitant radio-chemotherapy has become a standard therapy for advanced squamous cell~     carcinomas of head and neck. Local side effects caused by chemotherapy, like mucositis,~     increase in combination with radiotherapy. Mucositis, as a painful inflammation and~     ulceration of the oral mucosa, limits patient´s treatment plan. Studies showed that one third~     of the patients discontinued Chemotherapy because of the side effects. Accordingly to these~     side effects, patients eating habits get limited. This requires an increase of pain~     medication, mostly an opioid derivate, which causes side effects too, which requires other~     symptomatic medication. This requires a change of nutrition from hard to pappy food and at~     further impairing, liquid food is needed. A central vein catheter has to be done for parental~     nutrition and a gastrostomy for enteral nutrition, which means risk of haemorrhage and~     increased risk of bacteraemias and sepsis for the patient. This would mean a decrease of~     general condition and a dose reduction or treatment stop is needed. Accordingly, the results~     are treatment delay and prolongation of hospital stay.~      Risk of the study will be the known side effects of the products: Mitomycin-C,~     5-Fluorouracile, Cetuximab and radiation therapy. These are listed in the particular product~     description and the description of radiation thera-py. Another risk would be that the primary~     objective cannot be fulfilled. So the patients would have a lower quality of life than~     expected. Following benefits are expected.~      Benefit for patient:~        -  Decrease of mucositis and side effects caused by mucositis, also xerostomia, taste~          disturbances, dietary restrictions, dysphagia~        -  Decrease of pain medication and side effects caused by pain medication~        -  Decrease of surgical intervention (gastric tube, central venous catheter) and risks~          caused by the interventions (sepsis, bacteraemia, bleeding, injury of heart and stomach,~          etc.)~        -  Improving of patients social functioning, social eating, social contact~        -  No interruptions of therapy~        -  Increase of life quality~        -  Weight stabilization~      Benefit for clinical practice:~        -  Increase of compliance~        -  Fulfilling of complete therapy~        -  Hospital stays as planned~   "
118565|NCT02015637|"~     The purpose of this study is to evaluate the effects of a single oral dose of delafloxacin~     versus a single intramuscular injection of ceftriaxone in subjects with uncomplicated~     cervical, urethral, rectal, or pharyngeal gonorrhea.~   "
118566|NCT02015624|"~     This register will evaluate the use of different antithrombotic therapies, combinations of~     different drugs routinely used during any stage of hospital admission, with their timing,~     dosage and mode of administration, in patients with a diagnosis of Acute Coronary Syndrome in~     the Italian Coronary Care Unit during a study period of three weeks~   "
118567|NCT02015611|"~     The purpose of this study is to see if vitamin D supplementation improves muscle function.~   "
118568|NCT02015598|"~     Obstructive sleep apnoea syndrome (OSAS) is characterised by repeated episodes of upper~     airway occlusion during sleep.It can cause cycles of hypoxia reoxygenation. And it was~     postulated that intermittent hypoxia seems to resemble ischemia-reperfusion.Many study~     suggest that ischemia-reperfusion represents an oxidative stress causing increased generation~     of reactive oxygen species, especially superoxide anions.It is one of the most important~     mechanisms of cardiovascular diseases, including hypertension, coronary artery disease and~     cerebrovascular accident complication with OSAS.So many individuals approve OSAS is an~     Oxidative Stress disease.~      Continuous positive airway pressure (CPAP) is the first-line of treatment method in~     moderate/severe OSA.But poor adherence to CPAP treatment is very common.The failure rate with~     CPAP treatment is more than 50%.So we are searching a new treatment for that patients.~     Carbocysteine is a antioxidant.It can not only scavenges the free radicals but also~     replenishes glutathione(GSH)which is has double antioxidant capacity. However, Carbocysteine~     is cheaper than other which has double antioxidant capacity drugs,such as~     N-acetylcysteine.The purpose is to evaluate efficacy of oral intake of Antioxidant~     Carbocysteine witch can reduce oxidative stress and improve the symptom of OSAS.It recover~     the imbalance in the oxidant-anti-oxidant status may reduce cardiovascular abnormalities in~     Patients with OSAS.~   "
118569|NCT02015585|"~     The edentulism and use of inadequate dentures, unstable and with teeth worn because long~     period of usage can lead to an disharmony of the stomatognathic system due to gradual loss of~     occlusion vertical dimension resulting in inadequate mandibular movements and condyle-fossa~     relation. The reline of the denture base and the use of interocclusal appliance prior to~     definitive rehabilitation could have influence on these functional aspects. However, there~     are not Randomized Controlled clinical Trials (RCTs) testing the combined use of these two~     treatments in reestablishing these functional aspects. The, aim of this study is to evaluate~     whether the denture base reline and the use of interocclusal appliance prior to final~     rehabilitation have influence on mandibular movements and condyle-fossa relation, incomplete~     denture wearers. For this controlled, crossover, randomized and blinded clinical trial, 30~     volunteers, totally edentulous, complete denture wearer over a period of five year, will be~     selected. The volunteers will be randomly allocated into three subgroups (n= 10) and will~     receive the following treatments: Control (C)Volunteers will receive new complete denture~     without any previous intervention in their old complete denture; Relining Denture~     (RD)Volunteers will be submitted to the relining of the base of the their old complete~     denture and after 30 days of usage and before the replacement of the new complete denture, an~     evaluation will be performed; Interocclusal Appliance (IA) Volunteers will be submitted to~     the treatment with interocclusal appliance and after 30 days of usage and before the~     replacement of the new complete denture, an evaluation will be performed. Volunteers will be~     evaluated regarding the extent of mandibular movement by intraoral record of Gothic Gysi~     arch; condyle-fossa relation by cone-bean computed tomographic scan; occlusion vertical~     dimension by Willis compass and photographic record. These evaluations will be performed at~     three periods, T0 baseline; T1 after application of randomized treatment, reline denture and~     interocclusal appliance); T3 after final rehabilitation. The control group will be evaluated~     only at periods T0 and T3.~   "
118570|NCT02015572|"~     Low back pain (LBP) is a recognized public health problem with high life time prevalence.~     Medical treatment may reduce the physical and mental discomfort, while it has not been able~     to improve the possibilities for retaining or return patients with LBP to work.~      This is an occupational intervention study for patients with LBP and physically demanding~     work, who are at risk of drop out of labour; a randomized controlled trial designed to test~     the effectiveness of an early intervention for retaining subjects with LBP attached to the~     labour marked. A work place modification intervention combined with moderate physical~     activity is given in the intervention group additional to LBP treatments according to best~     practice recommendations for general practice.~      The study population consists of patients in self-reported physically demanding, who are sick~     listed or at risk of sick leave due to LBP. Outcome will continually be collected during the~     intervention as well as 6 and additionally at 12 months follow up.~      The primary aim is to evaluate if an occupational intervention with focus on early workplace~     orientated counselling and work place intervention can retain subjects with physically~     demanding work and LBP in gainful employment to prevent/reduce the sick leave due to LBP.~      The secondary aims are to identify prognostic factors of an occupational intervention using~     the baseline and follow-up participant-rated outcomes: pain, physically function, generic~     health status, fear avoidance behaviours, job satisfaction, work-ability, satisfaction with~     intervention, clinical examination and MRI findings. Among these variables, we also aim to~     identify subjects, who will benefit from such an occupational intervention, and the subjects,~     who already have a good prognosis and therefore have no need for a larger scale intervention.~   "
118571|NCT02015559|"~     This randomized phase II trial studies how well mucoadhesive oral wound rinse works in~     preventing and treating stomatitis in patients with estrogen receptor (ER)- or progesterone~     receptor (PR)-positive metastatic or locally recurrent breast cancer that cannot be removed~     by surgery receiving everolimus. Mucoadhesive oral wound rinse may help prevent symptoms of~     stomatitis, or mouth sores, in patients receiving everolimus.~   "
137736|NCT01764399|"~     Older adults caring for others often neglect their own health. This research is being done to~     see if helping caregivers focus on their own needs can improve their health and ability to~     care for others~   "
118572|NCT02015546|"~     This is an 8-week, randomized, double blind, parallel group, 3-arm trial to compare 10~     mg/day, 20 mg/day and 40 mg/day as starting doses of vilazodone following a switch from~     generic SSRIs and SNRIs. Vilazodone HCl under the trade name Viibryd™ is approved by the U.S.~     FDA for the treatment of major depressive disorder in adults. The purpose of this study is to~     evaluate the efficacy (how well the drug works), safety (the side effects), and tolerability~     (how well tolerated) of Vilazodone in preventing relapse or recurrence of depression. As~     vilazodone is not approved by the United States Food and Drug Administration (FDA) to prevent~     the recurrence of depression, for the purposes of this study it is considered~     investigational. The word investigational means that the study drug is still being tested~     in research studies and has not been approved for this use by the FDA.~   "
118573|NCT02015533|"~     The purpose of the study is to assess the safety, pharmacokinetics (what the body does to the~     drug) and immunogenicity (ability of a particular substance to provoke an immune response in~     the human body) of CR8020 in japanese healthy participants~   "
118574|NCT02015520|"~     The primary purpose of this study is to identify an appropriate dose of study medication.~   "
118575|NCT02015507|"~     To evaluate the effect of ciprofloxacin on the pharmacokinetics (PK) of ivacaftor and on the~     pharmacokinetics of VX-661 when administered in combination with ivacaftor~   "
118576|NCT02015494|"~     One dose of escalating strengths of an investigational influenza vaccine VAX2012Q~     (Quadrivalent Recombinant Hemagglutinin Seasonal Influenza Vaccine) will be evaluated for~     tolerability and immunogenicity in healthy adults 18-40 years of age.~   "
118577|NCT02015481|"~     The Purpose of this study is to assess the Safety, Tolerability and Efficacy of Intravenous~     Cabaletta® in Oculopharyngeal Muscular Dystrophy (OPMD) Patients.~   "
118578|NCT02015468|"~     A prospective, randomized study investigating the possible benefits of immediate mobilization~     and frequent physiotherapy following a wrist fracture treated by volar plating.~      The current study will test the following null hypothesis:~      There is no significant difference between patients who receive a cast for the first 2 weeks~     postoperatively and then instructions in home exercises and patients who receive a cast for~     2-3 days postoperatively and then have frequent sessions with a physiotherapist following~     volar locked plating for a extraarticular distal radius fracture, as evaluated by~     self-reported satisfaction after 3 months.~   "
118579|NCT02015455|"~     The overall goal of the Lumbar Image Reporting with Epidemiology (LIRE) is to perform a~     large, pragmatic, cluster randomized controlled trial to determine the effectiveness of a~     simple, inexpensive and easy to deploy intervention - insertion of epidemiological benchmarks~     into lumbar spine imaging reports - at reducing subsequent tests and treatments. The~     investigator's main hypothesis is that for patients referred from primary care providers,~     inserting epidemiological evidence in lumbar spine imaging reports will reduce subsequent~     diagnostic and therapeutic interventions, including cross-sectional imaging (MR/CT), opioid~     prescriptions, spinal injections and surgery.~   "
118580|NCT02015442|"~     AIMS To determine the effect of high and low sucrose diets on liver fat in healthy adult men~     with liver fat levels below 5%~      DESIGN Randomized, cross-over design with two 7-day dietary interventions separated by a 4~     week wash-out period. Dietary intervention will be based on iso-energetic substitution of~     sucrose for starch in a weight-maintaining diet. The two experimental conditions are: high~     sucrose diet at 25% of total energy intake (this is approximately the 95th percentile for UK~     intake of non-milk extrinsic sugars (NMES)); and low sucrose diet at 10% of total energy~     intake. Otherwise the macronutrient balance in both conditions will be based on UK average~     habitual intake.~      POPULATION 10 healthy males aged between 20 and 40 years, with a BMI between 20-25kg/m2, with~     normal liver fat levels (<5%) and fasting plasma glucose and no evidence of insulin~     resistance will be recruited. No pre-existing morbidity including cardiac, hepatic or renal~     disease, history of diabetes, hypertension or hyperlipidemia. Usual physical activity of~     subjects to range from sedentary to a maximum of meeting the UK minimum activity~     recommendations (30 min moderate exercise 5 d/week). Habitual alcohol intake of less than 2~     units per day.~      TREATMENT Pre-intervention: Participants will be asked to record habitual dietary intake by~     completion of a 7-day food diary and be asked to wear an accelerometer armband to assess~     physical activity before each intervention week. Resting energy expenditure will also be~     assessed by indirect calorimetry.~      7 day dietary interventions: Participants will be resident at the clinical research facility~     at Hammersmith Hospital during each intervention week for 5 out of the 7 days and all food~     will be provided at the facility. At the weekends, participants will have to leave the unit~     but food will be provided for those two days so that the diet can be continued at home.~      At the start and end of each 7 day intervention: Weight, height and waist circumference will~     be taken; percentage liver fat and total and regional body composition will be measured by~     MRI. Fasting and post prandial plasma glucose, insulin and lipids will be measured and blood~     pressure.~   "
118581|NCT02015429|"~     The investigators hypothesized that consuming isolated yellow pea fibre or protein, alone to~     together, as part of a high-carbohydrate pasta meal, would reduce the blood glucose response~     to the meal compared to a meal without yellow pea components and reduce food intake at a meal~     served 2 hours later.~   "
118582|NCT02015416|"~     This is a Phase I, multi-center, multiple ascending dose study to evaluate the clinical~     safety and immune response of IDC-G305 when injected intramuscularly in patients with~     unresectable or metastatic cancer. IDC-G305 is an immunotherapy consisting of recombinant~     NY-ESO-1 antigen and the adjuvant, GLA-SE. The goal is for IDC-G305 to stimulate the body's~     immune system to fight the spread and growth of cancer for patients whose tumors include the~     NY-ESO-1 protein. Patients with melanoma, ovarian, renal cell or non-small cell lung cancer~     may be considered for the trial.~   "
118583|NCT02015403|"~     Patient presenting with upper GI bleed in ILBS (Institute of Liver and Biliary Sciences)~     emergency admitted to ICU (Intensive Care Unit) or shifted from ward to ICU (Intensive Care~     Unit) in view of upper GI bleed randomized to two groups~      GROUP A : 70 Patients will receive standard care + NAC infusion for 72 hours~      GROUP B : 70 Patients will receive standard care only~      NAC will be given at following rate :~      Initial loading of 150 mg/kg/hr over 1 hour Followed by 12.5mg/kg/hr for 4 hrs Then~     continuous infusion of 6.25 mg/kg for the remaining 67 hrs~   "
118629|NCT02014792|"~     Studies suggest that dietary omega-3 fatty acids influence the extent to which the time~     interval between each heart beat varies (heart rate variability; HRV). Low HRV is associated~     with increased risk of sudden cardiac death (SCD). The purpose of this research is to~     investigate the relationship between 24 hour parameters of HRV and blood omega-3 fatty acid~     levels in patients who have recently commenced haemodialysis.~   "
118953|NCT02010541|"~     The first purpose of this study is to is to compare metabolic control of type 1 diabetes~     among children under the age of 7 years who use an insulin pump and a real-time (RT) glucose~     sensor, and children who use only insulin pump; the investigators will also determine dietary~     habits, their knowledge of type 1 diabetes management and emotional aspects of experiencing~     illness in the family, in both groups of children.~   "
118584|NCT02015390|"~     The United States Department of Defense (DoD) is funding exciting new research at the~     University of Texas Medical Branch (UTMB) Department of Orthopaedic Surgery and~     Rehabilitation that can be a major improvement in the treatment of extremity trauma involving~     segmental bone loss. These devastating injuries occur frequently in both civilians and the~     military. They typically result from motor vehicle accidents, high-energy fractures, gunshot~     injuries, and blast injuries, but also from the surgical removal of a bone segment because of~     infection or tumor. Despite many modern medical advances in this area, bone healing that can~     adequately replace bone loss and restore pre-injury limb function is extremely difficult to~     achieve. Existing standard treatment procedures are exceedingly complicated, require highly~     specialized equipment and clinical skills, and usually require many surgical procedures over~     many months or years. Despite these effort and costs, major complications usually occur with~     all the standard treatment options, the patient's ability to return to an acceptable~     functional status is typically low, and, therefore, many of these patients have their limbs~     amputated.~      The UTMB Department of Orthopaedic Surgery and Rehabilitation will conduct a DoD-funded~     clinical trial to determine and compare the advantages of two new and innovative surgical~     bone defect treatment techniques that can be significantly more effective for wounded~     warriors or civilian patients and with these conditions. One treatment method, called the~     Masquelet Technique, involves two-stage surgery: the first one to create a biomembrane~     around the defect by applying a cement spacer, and then the second one for cement spacer~     removal and defect bone grafting. The other method, developed by UTMB physicians, is the~     Cage Technique and it comprises one-stage surgery in which a special hollow, fenestrated,~     titanium cage filled with bone graft is implanted in the defect. Initial clinical experience~     with both of these techniques has been very promising, but to date, there has been no~     prospective clinical study comparing the two new methods of defect treatment. Identifying an~     optimal surgical bone defect reconstructive technique would significantly improve the~     clinical outcomes of patients with these challenging conditions.~   "
118585|NCT02015377|"~     The overall objective of FAME is to examine the metabolic and behavioral links between~     dietary intake and its subsequent effects on circulating appetite regulating hormones and~     physical activity levels in Hispanic and African American adolescents.~   "
118586|NCT02015364|"~     Study objectives To investigate if early controlled mobilization of the ankle in week 3 to 8~     affects the functional outcome and patient reported outcome after treatment of acute Achilles~     tendon rupture.~      Type of study~      Randomized, controlled trial (RCT). 130 patients will be included.~      Time schedule~      Begins January 2014. Study period is 4-5 years; recruitment is expected to span 2 years~      Setup At Copenhagen University Hospital Hvidovre the majority of patients with acute ATR are~     treated non-operatively. A cast is applied in the emergency room. After 2 weeks the bandage~     is changed to a removable orthosis and full weight bearing is allowed.~      Patients who choose to participate in the trial will - through randomisation - be placed in~     one of the two groups:~        1. The intervention group: Must perform controlled mobilization-exercises from the~          beginning of week 3.~        2. The control group: In line with the current treatment regimen the patients must keep the~          boot on at all times and they are not allowed to move the ankle.~      Treatment protocol for the two groups is similar concerning orthose, removal of wedges and~     weight-bearing. The only difference is that patients in the intervention group are instructed~     to do ankle exercise.~      Post-examinations in relation to the study Follow-up is done at 8 and 16 weeks plus 6 and 12~     months. The study's primary endpoint is at the 12 month mark.~      Population Patients who are treated for acute Achilles tendon rupture at Copenhagen~     University Hospital Hvidovre. Patients who fulfil the inclusion criteria but do not wish to~     participate are treated according the standard regimen (non-operatively without early~     controlled movement of the ankle joint).~      Number of patients 65 patients will be included in each group (a 130 patients in total).~   "
118587|NCT02015351|"~     Efficacy of monthly intravitreal anti-vascular endothelial growth factor (VEGF) associated to~     systemic immunosuppression in patients with Vogt-Koyanagi-Harada Disease and choroidal~     neovascularization. Minimum follow-up 12 months. Endpoints: 6 and 12 months of follow-up.~     Outcome measures: improvement of VA, decrease in central foveal thickness as measured by~     Optical Coherence Tomography (OCT) and absence of intra/subretinal fluid.~   "
118588|NCT02015338|"~     Hypothesis: In typically developing children (TDC), use of conventional EEG landmarks to~     determine the brain area that controls hand function will not differ from TMS-guided~     determination of individual motor hotspots. In children with hemiparesis, however, those two~     locations will diverge. The prediction is that TMS will best guide tDCS interventions~   "
118589|NCT02015325|"~     The objective of the study is to evaluate the impact of the Planet Water Foundation's~     intervention to improve Water, Sanitation and Hygiene related illness for reducing~     absenteeism and diarrheal episodes among school children resulting in improvement of their~     learning performance and ultimately long term economic prosperity.~   "
118590|NCT02015312|"~     Efficacy and safety of epigallocatechin-3-gallate (EGCG) in patients with cardiac amyloid~     light-chain (AL) amyloidosis. Evaluation of clinical efficacy of EGCG intake using a pretest~     posttest comparison of left ventricular amyloid mass (g/m2) measured by cardiac MRI.~   "
118591|NCT02015299|"~     Diabetes is associated with an increased risk for developing premature macrovascular~     complications. The process of irreversible subclinical damage to the vasculature already~     starts during its preceding stages. Dipeptidyl peptidase (DPP)-4 inhibitors have been shown~     to attenuate vascular damage in preclinical studies. Off-target effects on adipose tissue~     inflammation, liver steatosis and atherosclerotic plaques have been extensively documented in~     animal studies.~      Based on these considerations the investigators hypothesize that early therapy with the DPP4~     inhibitor linagliptin in subjects with treatment naive type 2 diabetes will lead to~     beneficial effects on arterial stiffness as measured by pulse wave velocity.~   "
118592|NCT02015286|"~     This is a Middle East, Multicenter, Observational Study to evaluate Adherence and Long Term~     Outcomes of Therapy in pediatric subjects using easypod™ electromechanical device for growth~     hormone treatment and to assess the level of adherence of subject receiving SAIZEN® via~     easypod™.~   "
118593|NCT02015273|"~     This is an Multinational, Multicenter, Observational Study to evaluate Adherence and Long~     Term Outcomes of Therapy in pediatric subjects using easypod™ electromechanical device for~     growth hormone treatment and to assess the level of adherence of subject receiving SAIZEN®~     via easypod™.~   "
118691|NCT02013986|"~     Etomidate is an unique drug used for induction of general anesthesia and sedation. Adrenal~     cortical inhibition by etomidate has received much attention. However wether the circadian~     rhythm and pulse secretion pattern of cortisol in children are the same as that in adults is~     not known. Moreover, the effect of etomidate on circadian rhythm changes and clinical~     outcomes has never been carefully studied in children undergoing surgery. Our hypothesis is~     that etomidate can relieve the changes of circadian rhythm of salivary cortisol in children~     for 24-48 hours，and this does not make clinical outcomes worse postoperatively.~   "
118594|NCT02015260|"~     Objective To assess the efficacy of the topical application of Nitric Oxide, delivered using~     acidified nitrite.~      Design Multicentre, randomized, controlled, dose ranging trial. A control arm and three doses~     of acidified nitrite applied topically for 12 weeks with a further 12 weeks of follow up.~      Setting The trial setting was in European genitourinary medicine clinics~      Participants Male and female volunteers over 18 years of age with between 2 and 50~     ano-genital warts, 328 were screened for eligibility and 299 subjects from 40 centres were~     randomised.~      Exclusions Pregnancy; concomitant Sexually Transmitted Disease; internal warts requiring~     treatment other than surgery /laser; diabetes ; Human Immunodeficiency Virus-positive,~     immunosuppressed and/or using immunosuppressive therapies; drug abuse.~      interventions compared~        -  Control Placebo nitrite cream and placebo citric acid cream twice daily~        -  A) 3% sodium nitrite + 4.5% citric acid creams twice daily~        -  B) 6% sodium nitrite + 9% citric acid creams once daily~        -  C) 6% sodium nitrite + 9% citric acid creams twice daily~      Outcomes~        -  Primary proportion of patients with complete clearance of target warts Secondary~        -  Time to clearance~        -  Wart area~        -  Wart count~        -  Patient and investigator assessment of efficacy~        -  Safety~        -  Tolerability~        -  Adherence~   "
118595|NCT02015247|"~     Pathogenesis of hip dysplasia Hip dysplasia is multifactorial in origin influenced by genetic~     and intrauterine factors, such as mechanical (rump presentation and oligohydramnios) and~     hormonal factors1. To ease the passage through the birth canal, the hip joint is quite mobile~     perinatally. Postnatally, the laxity of the ligaments will subside and the femoral head will~     normally position itself deeply in the acetabulum2. The theory is that if the femoral head~     does not migrate sufficiently into the acetabulum, dysplasia may develop because the matrice~     to stimulate acetabular growth is not correctly positioned. Normally, at birth the femoral~     head sits deep in the acetabulum held by surface tension of the synovial liquid. The growth~     and the hemispherical morphology of acetabulum are dependent on the presence of a normally~     growing and correctly placed spherical femoral head that works as a convex matrice. If for~     some reason the normal development is disturbed pre- or postnatally, pathologic relations may~     develop between the femoral head and the acetabulum3, leading to hip dysplasia.~      Purpose of this research project is to investigate if the correction of the acetabulum is~     accurately performed when the surgeon use navigation equipment during PAO.~   "
118596|NCT02015234|"~     This was an open-label, extension trial designed to evaluate the long-term safety over 12~     months of TNX-102 SL tablets taken daily at bedtime for the treatment of fibromyalgia.~     Patients recruited into this trial were those who had successfully completed the double-blind~     study, TNX-CY-F202 (F202) (NCT01903265). Patients were not made aware of the therapy they~     received during the double-blind study.~   "
118597|NCT02015221|"~     The purpose of this study is to determine the ease of use and comfort of the ACTitouch dual~     action pneumatic compression device in patients with unilateral or bilateral chronic venous~     insufficiency (CVI) with or without venous leg ulcers, as compared to standard compression.~   "
118598|NCT02015208|"~     The purpose of this study is to determine if Ruxolitinib, an inhibitor of cytokine-signaling,~     is effective in the treatment of patients with Chronic Lymphocytic Leukemia for whom~     conventional chemotherapy is either too toxic or ineffective.~   "
118599|NCT02015195|"~     The purpose of the study is to attempt to determine which treatment from commonly used~     treatments is the best at reducing pain and redness of the skin after a sting from a~     Portuguese Man of War, Chrysaora chinensis, or Chrysaora fuscescens.~      Jellyfish stings are a common occurrence in many parts of the world causing significant~     morbidity to persons stung by jellyfish while participating in marine activities whether~     commercial or recreational. Much debate and confusion exist both in the medical literature~     and the common recommendations regarding how to treat persons stung by jellyfish.~     Specifically concerning what topical treatments are most efficacious at decreasing~     envenomation by nematocyst on skin, preventing the firing of un-discharged nematocyst,~     decreasing inflammation and pain resulting from envenomation by nematocyst. Antidotal~     recommendations and past studies have referenced numerous different topical treatments for~     jellyfish stings including but not limited to vinegar, urine, alcohol, distilled spirits,~     ammonia, bleach, acetone, bicarbonate slurry, lidocaine, meat tenderizer, Coca Cola, old~     wine, salt water, cold packs, hot water, and commercial products such as Stingose and~     Stingaid. Conflicting data exists regarding what works and what does not for nematocysts~     discharge, skin erythema, and pain reaction.~      The investigators would like to investigate which treatment is best out of some of the more~     commonly studied treatments for reducing pain and erythema.~      The investigators would like to complete a research study to try to bring some reasonable~     evidence to the field treatment of jellyfish stings, namely, the decontamination process~     (e.g., what can you put on a jellyfish sting that will be helpful, based on real data?).~      The questions asked are as follows:~        -  What topical treatments for jellyfish stings actually decrease the amount of~          inflammation seen on a macroscopic level on the skin of humans?~        -  What topical treatments for jellyfish stings actually decrease the sensation of pain in~          humans?~        -  Do topical chemical treatments cause different outcomes when exposed to the above~          parameters?~        -  Do different species of jellyfish nematocysts react differently based on the type of~          topical chemical treatment used? What is the variation of effects of topical treatments~          based on the species of jellyfish sting?~      Specifically, the investigators will be stinging human subject on both arms with a segment of~     tentacle for approximately 2 minutes. This will be followed by no treatment on one arm~     (control arm) and by treatment on the other arm with either: acetic acid (5%), sodium~     bicarbonate slurry (50%), papain slurry (70%), ammonia (10%), viscous lidocaine (4%),~     isopropyl alcohol (70%), or hot tap water (40 degrees Celsius). Outcomes measured will~     include pain and erythema.~   "
118600|NCT02015182|"~     The aims of this study are to determine population PK parameters of bupivacaine in children~     following TAP block using a population-based PK approach, and to evaluate the influence of~     patient covariates on drug disposition.~   "
118601|NCT02015169|"~     We planned this study to investigate the efficacy and safety of XELOX (capecitabine and~     oxaliplatin) plus lapatinib treatment in HER2-positive gastric cancer patients with liver~     metastasis.~   "
118602|NCT02015156|"~     This study is to prove that there is no difference in the number of healthy male volunteers~     that will experience pyrexia (i.e. fever with body temperature of 38°C or higher) within a 24~     hour period after administration of a single dose of 6mg/kg of PF-05280014 or trastuzumab~     sourced from the United States (trastuzumab-US). The study will also compare the safety of~     both drugs.~   "
118603|NCT02015143|"~     The purpose of this study was to investigate the reliability and validity of the bipolar~     index (BPX) to diagnosis bipolar disorder, and to verify the stability of it in identifying~     bipolar disorder; the secondary purpose was to understand the dynamic changes of bipolar~     disorder in natural status.~   "
118692|NCT02013973|"~     The primary aim of this trial is to compare two groups of women undergoing IVF (IVF=in vitro~     fertilisation ) treatment, to investigate if assessment of AMH (AMH=Anti-Müllerian hormone ),~     in addition to assessment of maternal age, AFC (AFC=antral follicle count ) and BMI (BMI=body~     mass index ) gives a more optimal COH (COH=controlled ovarian stimulation than does~     assessment of only age, AFC and BMI, measured as number of patients obtaining 5-12 oocytes~     during COH.~   "
118604|NCT02015130|"~     The prevalence of Type 2 diabetes (T2D) is rising rapidly worldwide. In Denmark approximately~     8% of adults have T2D and more than 25.000 are diagnosed each year. This has vast~     consequences for society and the patient.~      Standardized treatment aiming at normalizing blood glucose and hypertension comparable to~     healthy individuals, have been tested in large studies. The effect on cardiovascular disease~     and other complications have been modest at best and one study showed an increased mortality~     with intensive treatment. The standardized treatment often results in polypharmacy, which~     increases the risk of patients discontinuing treatment.~      We propose a new approach to treatment of T2D, where the patients' individual characteristics~     are considered. The aetiology of the diabetes can be different, which warrants different~     treatment. Many patients have concomitant illness which can affect the way the patient is~     treated. A tight regulation of blood glucose can in some patient constitute a risk of adverse~     effects, especially hypoglycemia. In that sense individual targets for the treatment are~     important. Effective lifestyle treatment has importance for a successful outcome and we~     therefore offer an application that can help the patient and the physician organizing~     activity individually.~      The objective of individual treatment is to choose the most effective medication. If a~     prescribed drug does not have the desired effect it should be replaced with a different drug.~     The overall goal is to reduce the number of substances and side-effects, but simultaneous~     improve treatment and reduce the incidence of cardiovascular and other diabetes-related~     complications. This will in turn result in improved quality of life and improved adherence to~     treatment.~      The potential effect of individual tailored treatment of T2D is to improve the guidelines of~     treatment, not only to improve the patients' health, but also to reduce the socioeconomic~     consequences of the growing T2D prevalence~   "
118605|NCT02015117|"~     This phase I trial studies the side effects and best dose of trametinib with or without whole~     brain radiation therapy in treating patients with brain metastases. Trametinib may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation~     therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs, such as~     trametinib, may make tumor cells more sensitive to radiation therapy. Giving trametinib with~     whole brain radiation therapy may be a better treatment for brain metastases.~   "
118606|NCT02015104|"~     Background:~      - Many cancers produce two particular proteins. The immune system can target these to attack~     the cancer. The PANVAC vaccine puts genes for these proteins inside a virus vaccine so the~     body sees the proteins as foreign invaders and attacks them. Researchers will test PANVAC on~     people with high grade non-muscle invasive bladder cancer. They will give it to people who~     have not responded to the usual treatment, bacillus Calmette-Guerin (BCG) over several weeks.~     They want to see if PANVAC plus BCG is better than BCG alone.~      Objective:~      - To compare the effects of PANVAC plus BCG therapy, to BCG therapy alone.~      Eligibility:~      - Adults 18 and older with high grade non-muscle invasive bladder cancer who failed at least~     1 course of BCG.~      Design:~        -  Participants will be screened with blood and urine tests and abdominal scans.~        -  Participants will be randomly assigned to get BCG only or BCG plus PANVAC.~        -  They will have up to 10 visits over 15 weeks. Most of these are part of usual cancer~          care.~        -  They will have blood and urine tests.~        -  All participants will get BCG in 6 weekly injections.~        -  One group will also get PANVAC in 5 injections over 15 weeks.~        -  Between weeks 17 and 20, participants will undergo tests of the tumor area as part of~          their usual care. They will have cystoscopy, exam under anesthesia, and bladder biopsy.~          Results will be used to evaluate the different treatments.~        -  Participants will have quarterly follow-up visits for up to 2 years.~   "
118607|NCT02015091|"~     Background:~      - People bitten by mosquitoes carrying weakened malaria parasites could fight off the disease~     if later exposed to normal malaria parasites. Scientists have discovered how to make the~     weakened parasites, which can be injected by the PfSPZ vaccine. Researchers want to see if~     people who receive the vaccine get malaria after being bitten in a controlled setting (a~     controlled human malaria infection, CHMI).~      Objective:~      - To see if the PfSPZ malaria vaccine is safe and prevents malaria in a controlled setting.~      Eligibility:~      - Healthy adults 18 45 years old.~      Design:~        -  Participants will be screened with medical history, physical exam, blood and lab tests,~          and EKG.~        -  Participants will be split into 8 groups, to be in the study for 3 12 months.~        -  Participants will receive 3 5 vaccinations, injected by a needle in an arm vein or~          muscle.~        -  Participants will keep a health diary and be contacted by phone.~        -  For CHMI, a cup with mosquitoes carrying malaria is applied to participants arm for 5~          minutes. Five mosquitoes at a time are used, until 5 have bitten. Some groups will be~          exposed to malaria more than once.~        -  After CHMI, participants will visit the clinic very frequently (including daily visits~          for 12 days) for 28 days.~        -  Blood will be drawn at most visits, from 1 to 20 tubes. Physical exam and medical~          history may also be repeated~        -  Participants who develop malaria will be treated immediately at the clinic. Standard~          treatment takes 72 hours. Malaria symptoms may last up to 3 days.~   "
118608|NCT02015078|"~     Despite broad awareness of the role that diet plays in increasing obesity risk, adherence to~     public health recommendations for maintaining healthy eating is low. Insights gained from~     weight loss intervention trials find that trial participants report difficulty in restricting~     calories, dissatisfaction with the pace of weight loss, inability to control eating, low~     palatability of recommended foods and strong food cravings. Indeed, recent systematic reviews~     provide empirical support that these subjective experiences that trial participants describe~     likely represent eating-related traits or phenotypes . While amassing evidence supports~     individual variation in these eating-related traits, to date there has been no systematic~     effort to characterize robust eating-related phenotypes. Proposed is a Sub-study initially~     planned to be piggy-backed on a planned Study being conducted by investigators at the~     University of North Carolina (UNC-- Linnan, Dilworth- Anderson & Evans). The UNC Parent Study~     was a feasibility study using community-based participatory research (CBPR) approaches to~     explore possible intervention strategies aimed to reduce the burden of chronic disease and~     cancer among African American families. The NHGRI-led eating behavior Sub-study is proposed~     to be integrated with the UNC Parent Study (hereafter referred to as Phase 1). The additional~     aims of the Sub-study (hereafter referred to as Phase 2) are to gain understanding of whether~     we can characterize clusters of eating-related behaviors that may be associated with~     adherence to weight management and weight outcomes. This current protocol lays out the~     specific qualitative activities planned for Phase 1 which include conducting structured~     interviews with Black Family Reunion organizers (N=8) and a sample of reunion participants~     (N=40). We also describe the larger quantitative survey proposed for Phase 2. Pending the~     feasibility of the sub-study with the African-American community, we will collect information~     on eating-related behaviors in a large sample of individuals (N=350). If the initial~     assessments (Phase1) prove that this is not a viable study to be conducted in that setting,~     we will consider other population groups and other settings.~      We are also considering Phase 3 activities if we identify clusters of eating-related~     phenotypes within individuals. Amended IRB applications will be submitted prior to launching~     Phase 3.~   "
118693|NCT02013960|"~     1. Comparison between the duration of time from the beginning of cervical preparation until~          abortion, between sublingual misoprostol and the combination of sublingual misoprostol~          with laminaria for second trimester medical termination of pregnancy (TOP).~        2. Comparison between the adverse event rate following Sublingual misoprostol only vs.~          Sublingual misoprostol and laminaria given for pregnancy termination.~        3. Comparison between the levels of satisfaction rate of women who underwent pregnancy~          termination with sublingual misoprostol vs. sublingual misoprostol with laminaria.~   "
118609|NCT02015065|"~     Background:~      -Some people with wild-type gastrointestinal stromal tumors (WT-GIST) have a deficiency in~     one of their proteins called SDH. Vandetanib is a cancer drug that has been approved to treat~     thyroid cancer and has been used with some success in other tumors that have a similar loss~     of SDH. Researchers want to see if this drug can also decrease tumor growth in people with~     WT-GIST.~      Objectives:~      -To test whether the study drug will benefit people with WT-GIST.~      Eligibility:~      -Adults and children 3 years old and older with WT-GIST.~      Design:~        -  Researchers will test participants tumor tissue to confirm it is the wild type of GIST.~        -  Participants will be screened with a medical history, physical exam, and blood tests.~          They will also have electrical recording of the heart (ECOG) and scans of the tumor.~        -  Participants will take the study drug in 28-day cycles. Their doctor will decide how~          many cycles they can complete.~             -  They will take the study drug once every day and record it in a diary.~             -  On Day 14, they will also visit their doctor to look for side effects.~        -  Before cycles 2, 3 and 4, participants will have a physical exam, urine tests, blood~          pressure check, and blood tests. These tests will then be done periodically for as long~          as they are in the study.~        -  Before cycle 4, scans will be done to check the size of the cancer. Most of these will~          be repeated every 3-6 cycles.~        -  When they stop taking the study drug, participants will return to the clinic for a~          physicial exam and blood tests.~   "
118610|NCT02015039|"~     Objective: Writer s cramp (WC) is a form of focal hand dystonia (FHD). Focal injections of~     botulinum toxin (BoNT) are the current best therapy. Past studies showed that some types of~     rehabilitative therapy can be useful. The hypothesis of this study is that BoNT together with~     a specific type of occupational therapy will be better than BoNT alone for treating these~     patients. Additionally, studies on WC were hampered by the lack of objective, validated~     rating scales. In this pilot study, we will assess the value of a new scale compared with~     older scales.~      Study population: The study population will consist of 12 WC patients (accrual ceiling of~     16).~      Design: Patients will be randomized so that 6 patients will receive just BoNT therapy and 6~     patients will receive BoNT therapy plus occupational therapy. The physical therapy will~     involve specific exercises of finger movements in the direction opposite to the patient s own~     dystonic movements, during the writing task. The movements will be isometric against splints~     made to suit the individual patient. The final outcome will be assessed after 20 weeks of~     treatment. Patients will be evaluated on several scales, including the writer s cramp rating~     scale (WCRS) and writer s cramp impairment scale (WCIS), and will also be videotaped. The~     primary outcome will be based on patient reported subjective scale and the secondary outcomes~     will be assessed by four blinded raters of the videotapes, done both before and after~     treatment.~      Outcome measures: The primary outcome is to show additional improvement from baseline with~     BoNT therapy plus occupational therapy compared to BoNT alone at 20 weeks using a~     patient-rated subjective scale. The secondary outcomes are to show improvement in scores of~     WCRS, WCIS, WCDS, and writing parameters with a new handwriting analysis program.~     Additionally, the scores obtained from WCRS and WCIS will be compared.~   "
118611|NCT02015026|"~     Background:~        -  Adrenocortical carcinoma (ACC) is a rare tumor with an incidence of 1.5 to 2 per million~          people per year. It has a very poor prognosis with an overall 5-year mortality rate of~          75 - 90% and an average survival from the time of diagnosis of 14.5 months.~        -  The treatment of choice for a localized primary or recurrent tumor is surgical~          resection.~      Patients with recurrent or metastatic disease are infrequently curable by surgery alone.~        -  As with most solid tumors, chemotherapy options have limited benefit, although~          platinumbased therapies have response rates of 25 to 30%. To date no targeted therapy~          has been shown to be of any value in this disease.~        -  The natural history of ACC can vary greatly with some patients surviving only months~          while others can live with disease for years. The basis for these differing clinical~          presentations is not known. While one cannot exclude an immune or other host component~          as responsible for the diverse clinical courses, it is also possible that there may be a~          genetic basis for this phenomenon. A bio-specimen repository will be a major step~          towards more comprehensive studies of this very rare and unusual tumor, and allow us to~          begin to characterize subgroups within the disease.~        -  Patients with rare tumors seek expert advice in the management of their care. Dr. Fojo~          has such expertise and is frequently asked to consult in the care of ACC patients~          throughout the world. A natural history study would establish a more formal mechanism~          for such referrals, while allowing the systematic collection of epidemiologic data as~          well as much needed tumor samples.~      Objective:~      -To characterize the natural history of adrenocortical cancer, and in the process, collect~     blood, and tissue samples to study genetic/biochemical pathways involved in the development~     and progression of adrenocortical cancer (ACC).~      Eligibility:~        -  Patients greater than or equal to 12 years of age with biopsy-proven ACC~        -  Patients greater than or equal to 12 years of age suspected of having ACC~      Design/Schema:~        -  Patients will be offered clinical consultation with treatment recommendations, including~          standard of care and clinical trial options. Computed tomography scans of the thorax,~          abdomen and pelvis will be performed for staging purposes as indicated; occasionally,~          magnetic resonance imaging will be performed for the visualization of lesions in the~          liver, spine, or other anatomic sites.~        -  Medical histories will be documented and patients followed throughout the course of~          their illnesses, with particular attention to patterns of disease recurrence and~          progression, response to therapies, duration of responses and hormone production in~          patients with hormone production as a manifestation of their disease. Tumor growth rates~          will also be calculated throughout the course of the disease.~        -  Blood and tumor samples will be obtained at baseline and at follow-up intervals when~          surgery is indicated. Tumor samples may include samples harvested at other facilities~          during or prior to enrollment on this trial.~        -  Genetic and epigenetic analysis of tumors and in selected cases expression array~          analysis will be performed.~   "
118612|NCT02015013|"~     Idiopathic CD4 lymphocytopenia (ICL) is a rare syndrome defined by consistently low CD4 T~     cell counts (<300/mm3) without evidence of HIV infection or other known immunodeficiency.~     Patients with ICL are at risk for opportunistic infections typically associated with HIV/AIDS~     such as disseminated cryptococcal infection and severe human papillomavirus-related~     dysplasia. More than 20 years since the description of ICL, its etiology, pathogenesis, and~     management remain unclear. In this study we propose to administer the combination of~     granulocyte colony stimulating factor (G-CSF) and plerixafor to ICL patients and healthy~     volunteers with the objective of harvesting mobilized CD34+ hematopoietic progenitor cells~     (HPCs) by apheresis for transfer into immunocompromised mice and for study with in vitro~     assays. The mice studies would serve to investigate thymic development, survival, and~     trafficking of the mobilized human cells within murine lymphoid and non-lymphoid organs.~      HPCs are used for various therapies and there is an increasing use of agents that stimulate~     the bone marrow to produce progenitor cells and move them into the bloodstream where they may~     be harvested by apheresis. Not all patients respond to GCSF with vigorous HPC mobilization.~     The binding of chemokine receptor CXCR4 to stromal cell derived factor (SDF-1 or CXCL12) is~     an important interaction between a hematopoietic progenitor cell and its marrow environment.~     Plerixafor is a CXCR4 inhibitor which blocks binding to SDF-1 resulting in the release of~     hematopoietic progenitor cells (CD34+) into peripheral circulation. In pharmacodynamic~     studies of plerixafor in conjunction with G-CSF compared to G-CSF and placebo, a two-fold~     increase in CD34+ cell count was observed.~      Due to the important role CXCR4 plays in immune cell trafficking and its potential role in~     the pathogenesis of ICL, we propose as a secondary objective to assess peripheral CD4 T cell~     and CD34+ hematopoietic progenitor cell numbers and functions in ICL patients compared to~     controls following G-CSF and plerixafor administration.~      Study participants will be screened within 12 weeks prior to the study period. Eligible~     participants will receive G-CSF for 5 days with hospitalization on Day 4 for plerixafor~     injection followed by apheresis on Day 5. Participants will return for examinations and blood~     draws on Days 8 and 12.~   "
118613|NCT02015000|"~     The treatment of pterygium is still quite controversial. Previous studies using a large~     incision for pterygium excision and a large graft and has reported a very low recurrence rate~     with the P.E.R.F.E.C.T. technique. However, the P.E.R.F.E.C.T. technique is a relatively~     lengthy procedure and may not be suitable for patient with limited conjunctival reserve.~     Thus, we try to evaluate the final outcome of a sutureless amniotic membrane transplant~     technique combining the extended pterygium excision in hope to avoid the complication of the~     P.E.R.F.E.C.T. for PTERYGIUM technique.~   "
118614|NCT02014987|"~     About 31% of the Danish population participates regularly in running. The positive health~     benefits of running have been well documented in the literature. Unfortunately, running has~     been connected with a high risk of injuries.~      Running related injuries can cause a long rehabilitation and may even force the runner to~     quit running permanently. To ensure that running can be practiced as a safe exercise activity~     prevention must be considered.~   "
118615|NCT02014974|"~     Background: Worldwide injuries from trauma accidents represents a major population problem.~     The World Health Organization (WHO) has deemed this problem as one of the most important~     global priorities, calling 2011-2021 the Global Road Traffic Safety Decade. Despite this,~     there is little empirical data in low and middle-income countries quantifying the burden of~     fractures and the current practice of care.~      Methods: The investigators conducted a multicenter, prospective observational study of~     patients sustaining fractures or dislocations who presented to an orthopaedic fracture unit~     at 14 hospitals in India. A representative sample of patients were recruited during an 8-week~     period starting on October 1, 2012. Patients were followed up to 30-days in hospital or until~     discharge to determine if they suffered any outcomes. Primary outcomes included total~     mortality, reoperation, and infection.~   "
118616|NCT02014961|"~     Quest for modifier genes associated with ventricular arrhythmias in presence of a cardiac~     sodium channel gene (SCN5A-delPhe1617) mutation.~   "
118706|NCT02013791|"~     This study will evaluate a new ophthalmic formulation of cyclosporine (Restasis® X) in~     patients with moderate to severe dry eye disease in two stages. Up to 3 doses will be studied~     in Stage 2 based on results from Stage 1. No patients participating in Stage 1 will~     participate in Stage 2 of this study. This study was terminated and Stage 2 of the study was~     cancelled.~   "
119265|NCT02006459|"~     We want to investigate the mechanisms of extrapancreatic effects on gastrointestinal-mediated~     glucose disposal. In order to do so we will perform oral glucose tolerance tests and~     isoglycemic intravenous glucose infusions in total pancreatectomised patients and in healthy~     controls.~   "
118617|NCT02014948|"~     The lumbar spine is currently one of the most affected areas by nociceptive processes ,~     referred back pain, which can be provided from a herniated intervertebral disc . Such~     conditions are considered a public health problem , since considerably affect the population~     , mainly young adults , which may lead to functional disability and absenteeism . Soon , his~     treatment involves high costs and rehabilitation time indefinite , generating great~     scientific interest focused on the search for new techniques that can provide an acceleration~     of functional recovery of these individuals .~      Thus , the establishment of evaluation protocols that provide quantitative data concerning~     the functional capacity is of utmost importance . From the electromyographic analysis , one~     can measure the electrical activity of muscle and identify abnormal patterns of response. For~     the identification of kinematic changes becomes useful equipment capable of recording the~     speed and angle of movement, as the accelerometer . Another evaluation method applicable to~     cases of herniated disc and back pain is the force platform to quantify the ground reaction~     force during the stance phase of the movement . Also , the quality of life should be taken~     into account as routinely observed psychological impairment involving issues related to~     vitality, emotional and social aspects , which can be identified through the questionnaire of~     quality of life ( SF -36 ) .~      With regard to physical therapy intervention , we seek to use resources to compose promising~     treatment program along with conventionalexercises. A novel therapy in the treatment of back~     pain is the whole body vibration , as it promotes increased range of muscle spindles via~     increasing the tonic vibration reflex and consequently improving the mechanism of involuntary~     muscle control . Thus , the association between an accurate assessment , exercises and~     therapy vibratory seeks early rehabilitate individuals affected by back pain or herniated~     disc , delaying or even avoiding surgery .~   "
118618|NCT02014935|"~     The poor eating habits and sedentary lifestyle of young people can reflect on structural~     changes in adult life, leading to vascular brain diseases. The cerebrovascular accident (AVC)~     represents the second cause of death throughout the country. Presents rapid development of~     clinical signs, providing focal disorders or brain function. It is necessary to the knowledge~     and development of new treatment techniques that may minimize the sequelae caused by the AVC,~     which is a common disease and of great impact on public health, represents the main cause of~     adult neurological disability, affecting the basic functions of the limbs, motor control and~     balance, strength and mobility, which involves changes in daily life and low self-esteemIn~     addition to the high cost of treatment and in the long run.~      Thus, this study aims to analyze the response of low intensity laser on the prevention of~     pain and fatigue induced in rectus femoris, vastus of patients with sequelae of spasticity~     associated with effects on the laser promotes on muscle performance and muscle activity.~      It is believed that this study get positive results as regards the increase of time~     antecedent to muscular fatigue associated with the skeletal muscle performance, so that the~     normotonics muscles gain strength and overcome the resistance of hypertonic muscles. In this~     way, it is expected that after the application of low intensity Laser Therapy (LILT) occurs~     to the adequacy of spasticity, muscle function the gain that had provided the highest quality~     of physiotherapy care.~      It is known that treatment with the laser on the skeletal musculature, presents positive~     results and on the peak torque, by means of the skeletal muscle performance and consequently~     gain increase muscle performance (LEAL JUNIOR et al, 2010; ALMEIDA et al, 2011).~      Armed with this information you can infer that the low intensity laser therapy on the spastic~     muscle, would result in improving muscle performance, with an increase of pre-stressing,~     improving the functional capacity of individuals under the exercises imposed by physical~     therapy. In this way, the sessions will take more satisfactory results which jointly provided~     better quality of life for these patients.~   "
118619|NCT02014922|"~     Dry eye is a very common condition that most often affects women and the elderly, and can be~     caused when the eyes do not produce enough tears, or when the tears evaporate too quickly.~     Although there isn't a simple cure for dry eye, there are numerous products on the market~     that attempt to help relieve some of the discomfort caused by this condition. Some of these~     products include artificial tears, omega-3 supplements, and/or anti-inflammatory medications.~     The purpose of this study is to evaluate the performance of a combination of TheraTears®~     products, and to compare them with the product(s) you have been using.~   "
118620|NCT02014909|"~     Part I will evaluate the pharmacokinetic profile and safety of KTN3379 over several doses~     with the objective of defining a Phase 2 dose in patients with advanced malignancies. Part II~     will evaluate the pharmacokinetic profile and safety of KTN3379 in combination with other~     targeted agents and obtain preliminary evidence of anti tumor activity in specific types of~     cancer. Patients will continue receiving KTN3379 alone or in combination until disease~     progression or toxicity that necessitates discontinuation (whichever comes first).~   "
118621|NCT02014896|"~     The proposed study will validate the clinical use of new biomarker blood tests to identify~     blood components that may differentiate between diverse stroke etiologies and clinical~     outcomes as listed below:~        1. Differentiate between cardioembolic and large artery atherosclerotic ischemic strokes,~          when hemorrhagic stroke is ruled out.~        2. In cases of ischemic strokes of unknown or cryptogenic etiology, determine the ability~          of biomarker blood tests to predict etiology between cardioembolic and large artery~          atherosclerotic.~        3. In cases of cardioembolic ischemic stroke, further differentiation of cardioembolic~          ischemic strokes into those caused by atrial fibrillation (AF) and those not caused by~          AF.~        4. Differentiate transient ischemic attacks (TIAs) from acute ischemic strokes.~        5. Differentiate TIAs from non-ischemic transient neurological events (TNE) with similar~          symptoms.~   "
118622|NCT02014883|"~     The purpose of this project is to study the efficacy of triheptanoin oil in patients with~     GLUT1 deficiency syndrome.~   "
118623|NCT02014870|"~     The primary objective is to determine the dose level of live, wild-type A/California/ H1N1~     2009 virus that has an appropriate safety and illness/infectivity profile to be used as an~     influenza virus, challenge strain in future intervention studies.~      Illness parameters were collected by subject symptom scores as well as by physical~     examination. Virus parameters were measured by PCR and cell culture assay (performed by~     VisMederi srl).~   "
118624|NCT02014857|"~     Increased levels of cytokines in GCF have been demonstrated in smoker subjects with chronic~     periodontitis. It is not surprising that increased levels of inflammation associated~     molecules in GCF has been observed in smokers with periodontitis. However, it is not clear if~     smoking has an influence on these parameters in periodontally healthy individuals. In the~     present study, it has been hypothesized that smoking might affect the levels of GCF MMPs and~     growth factors in young adults with periodontal health.~   "
118625|NCT02014844|"~     This is a pilot study to determine the efficacy and safety of aldoxorubicin in subjects with~     glioblastoma who have progressed following surgery and prior treatments.~   "
118626|NCT02014831|"~     The purpose of this study is to evaluate the efficacy and safety of Cetuximab in metastatic~     penile carcinoma~   "
118627|NCT02014818|"~     To treat patients with stable coronary artery disease, elective percutaneous coronary~     intervention (PCI) will be performed with the use of an everolimus-eluting cobalt- chromium~     stent (everolimus-eluting stent: EES, Xience Prime, Xpedition), which is the current standard~     drug-eluting stent (DES). Vascular responses at the site of stent placement will be evaluated~     by optical coherence tomography (OCT) at 1 or 3 months and at 12 months after stent~     placement, along with observation of changes over time in the target vessel. The~     relationships between OCT findings and the time course of platelet aggregation and between~     OCT findings and the occurrence of major cardio- cerebrovascular events will also be~     elucidated.~   "
118630|NCT02014779|"~     Objectives: This study will evaluate the efficacy of internet-based relapse prevention with~     therapist support, as compared to face-to-face therapy at an employee assistance program. The~     design is a two-armed randomized controlled design, and outcomes are measured in terms of~     changes in problematic alcohol use, as well as depression and quality of life.~      Method: Participants with problematic alcohol use who, after an initial evaluation consisting~     of five face-to-face sessions with a licensed psychologist where alcohol and collateral~     problems are extensively assessed, are recommended treatment for problematic alcohol use.~     Consenting participants will be randomized into one of two groups: 1. Internet delivered~     relapse prevention with therapist support or 2. Face-to-face therapy. Outcomes on alcohol~     use, depression and quality of life as well as information on user satisfaction will be~     gathered post treatment. Follow up will be at 3, 6 and 12 months after completion.~      Our hypothesis is that the internet-based program with therapist support and the face-to-face~     therapy will be equally effective in reducing alcohol use (non-inferiority).~   "
118631|NCT02014766|"~     We hypothesize that both ultrasound-guided supraclavicular and interscalene block provide~     similar analgesia after shoulder surgery.~   "
118632|NCT02014753|"~     To treat patients with acute myocardial infarction, primary percutaneous coronary~     intervention (PCI) will be performed with the use of an everolimus-eluting cobalt- chromium~     stent (everolimus-eluting stent: EES, Xience Prime, Xpedition), which is the current standard~     drug-eluting stent (DES). Vascular responses at the site of stent placement will be evaluated~     by optical coherence tomography (OCT) at 2 weeks or 3 months and at 12 months after stent~     placement, along with observation of changes over time in the target vessel. The~     relationships between OCT findings and the time course of platelet aggregation and between~     OCT findings and the occurrence of major cardio- cerebrovascular events will also be~     elucidated.~   "
118633|NCT02014740|"~     The purpose of this research study is to learn about the effect of Liraglutide, (Victoza®),~     on the fat surrounding the heart.Excessive amount of the fat around the heart is common in~     people with type 2 diabetes and can be associated with poor sugar control. Liraglutide is an~     injectable prescription medicine that can improve blood sugar control in adults with type 2~     diabetes.~   "
118634|NCT02014727|"~     The primary objective is to evaluate the safety of 3 doses given at D0, W4, and W26 of 50 µg~     dosage of AMA1-DiCo adjuvanted either with GLA-SE or Alhydrogel® in healthy European adults~     not previously exposed to the parasite P.falciparum and in healthy African adults exposed to~     the parasite. The safety and the tolerability of the vaccine will be assessed on the rate of~     solicited and unsolicited events/reactions. The safety profile will include local and~     systemic reactions/events as well as the biological safety, based on a clinically significant~     change of the baseline value of the main biological criteria.~   "
118635|NCT02014714|"~     Obstructive Sleep Apnea (OSA) is a common clinical problem with a reported prevalence of 2%~     to 4% in the general population. The incidence was double on patients who had a diagnosis of~     OSA going for orthopedics surgery.~      Little literature composed mostly of case reports or small retrospective case-control studies~     exist examining the use of intrathecal opioids on outcomes in OSA patients is inconclusive.~     The primary objective of this study is to compare the post operative respiratory effect after~     single dose intrathecal morphine and intrathecal fentanyl on orthopedics patients who~     suspected or undiagnosed obstructive sleep apnea.~      Hypotheses~      Undiagnosed OSA patients who received intrathecal morphine are more likely to have~     respiratory events post-operatively.~   "
118636|NCT02014701|"~     The goal of this study will be to assess the incremental benefit of myocardial contrast~     echocardiography for the assessment of regional wall motion abnormalities and infarct-related~     artery in patients presenting with their first NSTEMI.~   "
118637|NCT02014688|"~     This study is being initiated to create a normal database including measures of optic nerve~     head (ONH), peripapillary retinal nerve fiber layer (RNFL), and macula using the Heidelberg~     Spectralis OCT device.~   "
118638|NCT02014675|"~     This registry is designed to gather further evidence, in addition to the SD01 Master Study,~     for the safety and efficacy of the SD01 ICD lead.~   "
118639|NCT02014662|"~     An isolated bout of unaccustomed maximal eccentric exercise is associated with muscle force~     loss for 2-4 days, mild reversible muscle tenderness, and ultra-structural damage to the~     muscle fibers, elevation of muscle proteins in serum, and a detriment in range of motion.~     This single center, pilot study is designed to optimize conditions for the robust measurement~     of functional deficits after muscle damage and to identify markers of repair over 22 days to~     inform future intervention studies. The primary measure will be limb force (assessed~     electronically from the ergometer), previous studies have demonstrated that functional~     measures return fairly rapidly, usually between 2-4 days. Additionally, several biomarkers of~     muscle function will be measured over 22 days, as well as changes in protein synthesis in~     biopsy samples Deuterium-labelled water (D2O) will be consumed by all study participants from~     Day-3 through Day 22 to aid in quantifying newly synthesized proteins.~   "
118640|NCT02014649|"~     This Phase 1/2 protocol is designed to collect safety, tolerability and pharmacokinetic data~     of two doses of Laninamivir Octanoate in children and adolescents. The protocol will also~     explore virology and efficacy endpoints.~   "
118641|NCT02014636|"~     This is an open-label, 2 part study of pazopanib and/or MK 3475 in treatment naïve subjects~     with advanced RCC. Part 1 consists of a Phase I dose escalation of pazopanib + MK 3475~     followed by an expansion cohort to determine the maximum tolerated regimen and the~     recommended Phase II dose. Part 2 is a randomized 3-arm Phase II study to evaluate the~     clinical efficacy and safety of pazopanib + MK 3475 as compared to single-agent pazopanib and~     single-agent MK 3475. The objectives of this Phase I/II study are to test the safety and~     tolerability of pazopanib in combination with MK 3475, and study the clinical efficacy of~     pazopanib in combination with MK 3475 in subjects with advanced RCC as compared with~     single-agent pazopanib and single-agent MK 3475.~      Following the Urgent Safety Measure (USM) released on February 09, 2017, the phase II (Part~     2) portion of this study will not commence.~   "
118707|NCT02013778|"~     Primary Phase I:To determine dose limiting toxicities and maximum tolerated dose (MTD) of the~     oral administration of hydroxychloroquine (HCQ) in conjunction with transarterial~     chemoembolization (TACE) in treating hepatocellular carcinoma (HCC). A conventional 3+3~     design will be utilized. Primary Phase II: To evaluate the complete response rate in a cohort~     of patients treated at the MTD, A Simon's Optimal Two-stage design will be utilized.~   "
118642|NCT02014623|"~     Allergic diseases represent a major health issue worldwide and epidemiological studies in~     Melbourne, Australia, have reported a high prevalence of rhinitis (hayfever) and atopy~     (genetic tendency to make allergy antibody) in Asian and Caucasian subjects. Mainstay~     treatment of allergic rhinitis is allergen avoidance and pharmacotherapy for symptom relief.~     Allergen immunotherapy offers the advantages of specific treatment with long lasting~     efficacy, and can modify the course of disease. However, use of this treatment is restricted~     by the high risk of adverse events especially in asthmatics. Other, better tolerated, routes~     of allergen administration than the current conventional subcutaneous route (SCIT) have been~     investigated including the sublingual route (SLIT) and recently sublingual tablets for pollen~     allergy immunotherapy became available. The tablets are safe and easy to use and contain~     pollen extracts from 5 of the most common allergy-causing European grasses but include~     ryegrass (Lolium perenne), the major seasonal pollen for allergy in Melbourne and~     south-eastern Australia. The immunological mechanisms of sublingual immunotherapy are not~     fully understood. The investigators propose conducting a longitudinal open label study to~     investigate the immunological changes that occur with the 5 grass pollen sublingual~     immunotherapy tablet (Oralair®) in a cohort of Chinese and non-Chinese background subjects.~     The investigators will investigate the induction of relevant T cell regulatory immune~     mechanisms and changes in serum allergen-specific immunoglobulin (Ig) E and IgG4.~     Immunoregulatory cytokine synthesis and T cell phenotype (Bio-plex and flow cytometry) will~     be examined. This project will provide important fundamental knowledge on which to inform~     decisions for the greater application of this treatment for subjects with moderate and severe~     allergic rhinitis.~   "
118643|NCT02014610|"~     The complete blood count is a commonly performed blood test, and previous small studies have~     suggested that the counts of some types of white blood cell in the complete blood count may~     be related to the onset of cardiovascular diseases such as stroke and heart attack. This is~     of interest because this information may help to predict strokes or heart attacks and may~     guide new therapies which act on white blood cells to reduce the risk of cardiovascular~     disease.~      The hypothesis is that counts of particular types of white blood cell are associated with a~     range of cardiovascular diseases.~   "
118644|NCT02014597|"~     The purpose of this study is to determine if an optokinetic contrast detection device is~     sufficient to measure contrast sensitivity and to distinguish between patients with and~     without glaucoma.~   "
118645|NCT02014584|"~     Treatment of male pattern hair loss (MPHL) or androgenetic alopecia (AGA) with 5α-reductase~     inhibitor (5-ARIs) has been associated with sexual dysfunction including erectile dysfunction~     and loss of libido. This will be a multicenter, randomized, double-blind, placebo-controlled,~     parallel-group study to assess the impact of dutasteride treatment on sexual function as well~     as subject satisfaction with hair growth and quality of life in men with AGA. This study will~     consist of a Screening Visit, a 4-week Placebo Run-in Phase, a Treatment Phase of 48 weeks,~     and a subsequent Follow-up Visit after 4 weeks. The treatment phase will include 24 weeks of~     double-blind, placebo controlled treatment and 24 weeks of open-label treatment with~     dutasteride. An extended 6-month Follow-up Visit will be conducted for any individuals with a~     change in erectile function at the end of treatment.~   "
118646|NCT02014571|"~     GSK2878175 is a site IV NS5B non-nucleoside inhibitor (NNI) being developed for the treatment~     of chronic hepatitis C virus (HCV) infection. The purpose of this study is to investigate the~     effects of GSK2878175, at different doses in men and women infected with chronic hepatitis C~     virus. The study will investigate how much of the drug gets into the blood stream and how~     long the body takes to get rid of it. The study will also investigate if GSK2878175 has any~     important side effects. The study will also measure what effect GSK2878175 has on the~     hepatitis C virus infection after taking the study medication for 2 days. Approximately 44~     people will take part in this study. Depending on the type of chronic hepatitis C infection a~     subject will be enrolled into 1 of 4 groups randomly. Each group will participate in one~     dosing session. One dosing session consists of GSK2878175 or a placebo (sugar pill) given~     once per day for 2 days.~      Group A, B, and C is made up of 8 participants per group. In each of these groups 6~     participants will receive GSK2878175 and 2 participants will receive placebo. Group D is made~     up of 20 participants. 15 participants will receive GSK2878175 and 5 participants will~     receive placebo. The treatment groups will be dosed in sequence. Group A will be the first to~     take the study medication, then Group B, and so on. The plan is to dose subjects in Group A~     with 10 mg, Group B with 30 mg, Group C with 60 mg, and Group D with 60 mg of GSK2878175 or~     placebo. The next treatment group's actual dose will be decided after looking at the results~     from the previous group. The doses may therefore be higher or lower than planned depending on~     the previous group's results. The number of participants enrolled in the next group may also~     change depending on the results from the previous group.~   "
118647|NCT02014558|"~     The objective of this study is to assess the safety and tolerability, including the maximum~     tolerated dose, of ASP2215 in subjects with relapsed or treatment-refractory acute myeloid~     leukemia (AML). This study will also determine the pharmacokinetic (PK) parameters of~     ASP2215.~   "
118648|NCT02014545|"~     This is a randomized, double blind placebo controlled study to evaluate safety and efficacy~     of lucanthone administered as an adjunct to patients receiving whole brain radiation therapy~     (WBRT) as primary treatment for brain metastases secondary to non-small cell lung cancer.~   "
118649|NCT02014532|"~     The adjunctive use of Leukotriene Receptor Antagonist (Montelukast) along with scaling and~     root planing in patients with chronic periodontitis leads to host inflammatory response~     modulation and decrease in serum C reactive protein (CRP) levels. If proven this will open~     new vistas in treatment of chronic periodontitis.~   "
118650|NCT02014519|"~     The purpose of this study is to perform a epidemiological survey of the adult population in~     Hungary to calculate the seroprevalence of pertussis.~   "
118651|NCT02014506|"~     Purpose of study: This phase I/II trial is to evaluate the safety and feasibility of~     TCRαβ-depleted graft from haploidentical family donors in treating children and adolescents~     with malignant or non-malignant diseases.~   "
118675|NCT02014194|"~     Obsessive-compulsive disorder is a chronic condition. Even with proper treatment, no~     significant improvement is reached in about 30% to 40% of patients. Thus, the development of~     new treatment strategies is necessary. The attentional bias - ability to aversive stimuli in~     capturing the attention of an individual compared to a neutral stimulus - has been~     extensively studied. Already training attentional bias modification has been shown effective~     in reducing anxiety present in other anxiety disorders.This project aims to: 1 - generate~     knowledge on attentional bias in individuals with OCD through the use of a standardized~     protocol developed for OCD; 2 - available to the scientific community the first specific~     paradigm for the study of attentional bias in OCD patients, 3 - test the effectiveness of a~     training protocol for reversing attentional bias in individuals with OCD.~   "
118652|NCT02014493|"~     Continuous Positive Airway Pressure (CPAP) is used to treat preterm infants with an immature~     respiratory center and having respiratory distress. CPAP requires intensive care monitoring~     and special qualified staff. Continuous positive pressure makes a constant noise around the~     child and can lead to an uncomfortable environment.The fixture of the binasal prongs can~     cause nasal trauma after to tight attachment.Minimizing the time on CPAP is considered~     important for the child.~      Recently High-Flow Nasal Cannula (HFNC) has become widely used in modern newborn intensive~     care units.HFNC is considered to be easy to apply and a more comfortable respiratory support~     for the preterm infant with mild and moderate respiratory distress. HFNC gives warm humified~     air with high flow through a nasal cannulae. HFNC is used as part of withdrawal from~     intensive respiratory support, to prevent respiratory distress and as a respiratory support~     after extubation.~      There is still uncertainty about safety and effectiveness of HFNC. The aim of this study is~     to investigate the preterm infants respiratory effort by measuring electrical activity in~     diaphragm (Edi max and Edi min), respiratory parameters and a clinical observation using a~     scoring system inspired by Silverman- Andersen retraction score. It is expected that measured~     electrical activity in the diaphragm, measured respiratory parameters combined with bedside~     observations provide applicable knowledge about preterm infants respiratory effort in~     transition from CPAP to HFNC.~   "
118653|NCT02014480|"~     This is a multicenter, randomized, double-blind, 3-way crossover study to evaluate the lung~     function response to UMEC 62.5 mcg, VI 25 mcg, and UMEC/VI 62.525 mcg, administered~     once-daily via a novel dry powder inhaler (NDPI) over 14 days in subjects with COPD.~      The study consisted of Run in Phase (5 to 7 days), Treatment Phase (made up of 3 treatment~     periods of 14 days each separated by 10 to 14 days Washout Period) and Follow-up Phase (7 to~     9 days after completion of final visit or premature discontinuation). Eligible subjects will~     be randomized to a sequence of UMEC 62.5 mcg, VI 25 mcg, and UMEC/VI 62.5/25 mcg such that~     all subjects will receive each treatment.~      Serial spirometry assessments will be conducted on Day 1 and Day 14 and trough spirometry~     will be conducted on Day 2 and Day 15 of each treatment period. On Day 1 and 14 of each~     treatment period vital signs will be assessed and adverse event (AE)s will be recorded~     throughout the total duration of the study (approximately 12 weeks).~   "
118654|NCT02014467|"~     This study is to evaluate the efficacy and safety of denosumab 60 milligrams (mg) for 12~     month treatment in Chinese postmenopausal women with osteoporosis at increased risk of~     fracture.~   "
118655|NCT02014454|"~     The aim of the present study is to evaluate the safety and efficacy of propranolol eye drops~     in preterm newborns with a precocious stage of retinopathy of prematurity (ROP). Preterm~     newborns (gestational age 23-32 weeks) with a stage 2 ROP (zone II without plus) will receive~     propranolol eye drops treatment until retinal vascularization will be completed.~      Propranolol concentrations will be measured on dried blood spots during the first 3 days of~     treatment and at the steady state. Cardiovascular and respiratory parameters will be~     continuously monitored. Blood samplings checking metabolic, renal and liver functions will be~     performed periodically, as well as cardiac function, in order to verify the treatment safety.~     Serial ophthalmological evaluations will be planned to monitor the efficacy of the treatment,~     the ROP progression and the possible complications.~   "
118656|NCT02014441|"~     The primary objective was to estimate the proportion of participants with detectable~     talimogene laherparepvec deoxyribonucleic acid (DNA) in the blood and urine at any time after~     administration of talimogene laherparepvec within the first 3 cycles.~   "
118657|NCT02014428|"~     To evaluate the effectiveness of low molecular weight hyaluronic acid oral tablets for the~     treatment of atrophic vaginitis.~   "
118658|NCT02014415|"~     The investigators hypothesize that there is liver injury (inflammation, fibrosis, cirrhosis)~     in adults with Alpha-1 Antitrypsin Deficiency (AATD), which is asymptomatic,~     under-recognized, and undiagnosed. In addition, the investigators believe that the genetic~     and environmental factors that play an important role in the development of alpha-1~     antitrypsin (AAT) liver disease, can be identified by comparing a cohort database of clinical~     disease information to linked biospecimen and DNA samples.~   "
118659|NCT02014402|"~     This purpose of this clinical trial was to study the safety and efficacy of Topical Thrombin~     (Human) Grifols as an add-on treatment to help stop bleeding during vascular, liver, soft~     tissue, and spinal surgical procedures.~   "
118660|NCT02014389|"~     Objective perimetry can better monitor visual field defects in retinal dystrophy and Glaucoma~     patients than conventional subjective perimetry. The PLR ( Pupil Light Reflex to short and~     long wavelength stimuli should be significantly lower compared to healthy participants in~     areas of visual field defects in retinal dystrophy and Glaucoma patients.~   "
118661|NCT02014376|"~     The purpose of this study is to assess whether SD-101 cream (3% or 6%) is effective in~     treating the lesions in subjects with Simplex, Recessive Dystrophic, or Junctional~     Epidermolysis Bullosa.~   "
118662|NCT02014363|"~     To demonstrate that the antidepressant activity of ETS6103 is not inferior to amitriptyline~     in subjects who have an unsatisfactory response to / are resistant to treatment with SSRIs.~   "
118663|NCT02014350|"~     To collect medium to long-term survivorship implant outcomes on the DePuy Delta Xtend Reverse~     Shoulder Stystem.~   "
118664|NCT02014337|"~     This is a study to assess the safety of the combination of mifepristone and eribulin in~     patients with metastatic or locally advanced unresectable breast or other specified solid~     tumors, and determine preliminary efficacy of the combination of mifepristone and eribulin in~     patients with metastatic or locally advanced unresectable Triple Negative Breast Cancer~     (TNBC). The structure for the study is a single arm, non-randomized, open-label, multicenter~     trial with no control group. The study will be conducted at up to 11 sites, with up to 40~     evaluable patients~   "
118689|NCT02014012|"~     Arterial stiffness has been suggested as an independent risk factor for the development of~     coronary artery disease and stroke. Pulse wave velocity (PWV) is an noninvasive established~     index to quantify arterial stiffness. Therefore, we try to investigate the correlation~     between PWV values and cardiovascular complications like stroke, acute renal failure, or~     perioperative myocardial infarction after cardiac surgery.~   "
118690|NCT02013999|"~     Using the upper extremity rehabilitation program developed by virtual reality would help the~     recovery upper extremity function in patients with stroke.~   "
118665|NCT02014324|"~     Rationale: Lung cancer is the most commonly diagnosed cancer worldwide and is the most~     frequent cause of cancer death. Accurate staging is important because it directs treatment~     and prognosis. Mediastinal staging can be done by both EBUS-TBNA and EUS-FNA. These two~     techniques have a complementary diagnostic range and the combined procedure is suited for~     assessment of almost the entire mediastinum. In practice, when mediastinal tissue staging is~     indicated, endoscopists often perform either an EBUS or an EUS investigation (instead of the~     combined procedure). Second, frequently only one or two, by imaging suspected lymph node~     stations, are sampled (ie. targeted approach).~      Objectives: main and secondary:~        1. Complete endosonographic (combined endobronchial and esophageal) staging using a single~          EBUS scope improves locoregional staging (N2, N3, T4) versus EBUS staging alone.~        2. Systematic mediastinal staging results in improved locoregional staging compared to~          PET-CT directed assessment of the mediastinum (ie targeted approach).~      Study population: Patients with potentially operable and resectable NSCLC are eligible if~     there is an indication for mediastinal nodal sampling. Patients have an indication for~     EBUS-TBNA.~      Intervention: Patients will undergo an EBUS investigation followed by EUS-B in the same~     session. During this single scope procedure, lymph nodes that are suspected on prior CT-PET~     imaging and on subsequent ultrasound are sampled.~      Main study endpoint: The main study parameter is the sensitivity for locoregional disease~     (N2, N3, T4 disease) of complete endosonographic staging (by EBUS-TBNA and EUS-B-FNA) in~     comparison with EBUS staging alone.~   "
118666|NCT02014311|"~     The aim of this study is to assess whether the clinical management of patients with recent~     acute-onset chest pain without acute coronary syndrome may be optimized by a combined~     coronary CT angiography (CTA) + CT myocardial perfusion (CTP) guided, rapid diagnostic~     strategy as compared to CTA alone. CT diagnostic evaluation and potential referral for~     invasive testing will be performed within 2 weeks after hospital discharge.~      The following main hypothesis will be tested:~      - Combined assessment of coronary anatomy and myocardial perfusion using 320 MDCT results in~     a safe and optimized, cost-effective invasive treatment strategy~   "
118667|NCT02014298|"~     BACKGROUND: Increasing evidence appears for non-ablative fractional laser (NAFL) to remodel~     mature burn scars.~      OBJECTIVES: To investigate long-term clinical and histological appearance of mature burn~     scars after NAFL-treatment.~      HYPOTHESIS: That NAFL can modulate mature burn scars with subsequently improved cosmetic and~     functional appearance.~      METHODS: Study patients with burn scars at trunk or extremities. Side-by-side test areas are~     randomized to three monthly 1,540 nm NAFL-treatments or control, followed by blinded~     evaluations at 1, 3, and 6 months using mPOSAS (modified Patient and Observer Scar Assessment~     Scale; 1 = normal skin, 10 = worst imaginable scar).~   "
118668|NCT02014285|"~     Examination of serial muscle ultrasounds and muscle sampling within the population of ICU~     patients who require mechanical ventilation for acute respiratory failure, will lead to the~     ability of investigators to link specific baseline comorbidities, drugs, or fluid~     administrations, to the onset and duration of architectural changes within muscle and~     correlate ultimately with muscle function. With this study, we will be better able to~     understand the relationships between the pattern of resolution of the muscle architectural~     abnormalities within the context of multiple other clinical abnormalities and therapies~     present and rendered to ICU patients.~   "
118669|NCT02014272|"~     This is a bioequivalence study to evaluate the bioequivalence of RIN 150 against individual~     reference drugs in healthy volunteers.~   "
118670|NCT02014259|"~     This trial is conducted in Europe. The aim of the trial is to investigate the~     pharmacokinetics (the exposure of the trial drug in the body), safety and tolerability of~     oral semaglutide in subjects with various degrees of impaired renal function compared to~     subjects with normal renal function.~   "
118671|NCT02014246|"~     Background:~      There are two basic types of movement disorders. Some cause excessive movement, some cause~     slowness or lack of movement. Some of these are caused by mutations in genes. On the other~     hand, dementia is a condition of declining mental abilities, especially memory. Dementia can~     occur at any age but becomes more frequent with age. Researchers want to study the genes of~     families with a history of movement disorders or dementia. They hope to find a genetic cause~     of these disorders. This can help them better understand and treat the diseases. This study~     will not be limited to a particular disorder, but will study all movement disorders or~     dementias in general. This study will perform genetic testing to identify the genetic causes~     of movement disorders and dementia. Today, genetic testing can be done to analyze multiple~     genes at the same time. This increases the chances of finding the genetic cause of movement~     disorders and dementias.~      Objectives:~      To learn more about movement disorders and dementia, their causes, and treatments.~      Eligibility:~      Adults and children with a movement disorder or dementia, and their family members.~      Healthy volunteers.~      Design:~      Participants will be screened with medical history and blood tests. Some will have physical~     exam.~      Participants will give a blood sample by a needle in the arm. This can be done at the clinic,~     by their own doctor, or at home. Alternatively, a saliva sample may be provided if a blood~     sample cannot be obtained.~      Participants can opt to send an extra blood sample to a repository for future study. Genetic~     test will be done on these samples. The samples will be coded. The key to the code will~     remain at NIA. Only NIA investigators will have access to the code key. Participants can~     request to receive results of the tests.~      Participation is generally a single visit. Participants may be called back for extra~   "
118672|NCT02014233|"~     Nerves are the rate limiting factor that control muscle function. However, it is unknown if a~     nutritional supplement can change the nerve-muscle interaction, and therefore alter human~     performance. This study will be the first to examine the effects of omega-3 supplementation~     on neuromuscular function in trained individuals.~   "
118673|NCT02014220|"~     Potato is one of the world's most popular foods and is widely accepted as a staple food. The~     objective of this study is to determine the effect of consuming potato chips from different~     cultivars on blood glucose, subjective appetite and food intake. It is hypothesized that the~     chips produced from various potato cultivars will differ in their effect on blood glucose,~     satiety and food intake.~   "
118674|NCT02014207|"~     Potato is one of the world's most popular foods and is widely accepted as a staple food. The~     objective of this study is to determine the effect of altering commercial blanching and~     cooling times during manufacture of frozen fries produced by the on blood glucose, satiety~     and appetite. It hypothesized that the processing regime predetermines the physiologic~     responses to ingested product and therefore it is possible to produce healthier product lines~     of potato fries.~   "
118708|NCT02013765|"~     This study will evaluate the efficacy and safety of intravenous Herceptin in patients with~     metastatic urothelial cancer with disease progression during platinum-based chemotherapy. The~     anticipated time on study treatment is until disease progression.~   "
118709|NCT02013752|"~     The purpose of this study is to determine whether a modified perineum protection device can~     reduce tearing during delivery.~   "
118676|NCT02014181|"~     Flaxseed (FS) is a safe and well tolerated supplement with an ability to fight inflammation~     and oxidative stress - a byproduct of daily stress the human body faces everyday and~     especially with chronic diseases. Cystic fibrosis (CF) is a genetic disease resulting from a~     mutation in sodium and chloride transport channels that results in pancreatic insufficiency,~     chronic sinusitis and chronic lung infections. The investigators hypothesize that chronic~     inflammation and oxidative stress are a part of the chronic exacerbations that are a part of~     cystic fibrosis. The investigators believe that flaxseed with its anti-inflammatory and~     antioxidative properties can help dampen these stressors on the CF lung and potentially~     result in fewer exacerbations of CF, fewer antibiotics, fewer hospitalizations, and improved~     well-being.~   "
118677|NCT02014168|"~     This is a single blinded placebo controlled phase I study, to assess the safety and~     immunogenicity of co-administration of the candidate influenza vaccine MVA-NP+M1 with the~     Viroflu® seasonal influenza vaccine. All volunteers recruited will be healthy adults aged 18~     and over.~   "
118678|NCT02014155|"~     Intended to treat disorders of the respiratory muscles can use the device Threshold IMT ®~     through an inspiratory muscle training (IMT) that allows training of the inspiratory muscles,~     the chief of these being the diaphragm which is which objectified the improvement of its~     function . To monitor the action of the respiratory muscles can be used several tools such as~     manometer that aims to assess respiratory pressures, ie, the strength of respiratory muscles,~     or the Surface Electromyography (sEMG) that allow evaluating the electromyographic activity~     of muscles analyzed. From a quantitative clinical trial, randomized and blinded, composed of~     45 individuals obtained by random convenience and divided into three groups, COPD~     participating in a pulmonary rehabilitation program (RP) which will make TMI (TGR - Trained~     Group Rehabilitated), COPD does not participant in a PR program (TGNR - Trained Group not~     Rehabilitated) and a control group composed of healthy individuals (CG) that seek to analyze~     the electromyographic activity of sternocleidomastoid (SCM) and diaphragm muscle strength,~     lung volumes and breathing patterns before and after a period of eight weeks of TMI. Manual~     will also be held dynamometry to compare the grip strength of the CG, TGR and TGNR only at~     baseline.~      Hypothesis:~        1. The Inspiratory Muscle Training (IMT) increases the maximal inspiratory pressure (MIP)~          in COPD patients regardless of whether they are enrolled in a program of pulmonary~          rehabilitation (PR).~        2. TMI alters the breathing pattern in COPD patients regardless of whether they were~          entered into a PR program.~        3. Patients with COPD who do not participate in a PR program have higher handgrip strength~          compared to patients who did not participate in a PR program.~        4. There is decreased activity of the sternocleidomastoid muscle due to increased activity~          in the diaphragmatic muscle fibers after a period of TMI.~        5. TMI in COPD patients participating in a program RP produces greater increase in MIP, the~          handgrip strength, improves breathing pattern and a greater reduction in the activity of~          the SCM muscle and diaphragm than in those who did not participate in a program RP.~        6. There will be a reduction in respiratory rate, heart rate, systolic and diastolic blood~          pressure and increased oxygen saturation at the end of the TMI.~        7. TMI reduce the degree of dyspnea reported by patients as MRC scale at the end of the~          training period.~   "
118679|NCT02014142|"~     Determine efficacy of the latanoprost punctal plug. Effect of configuration of L-PPDS~     placement on efficacy will also be examined.~   "
118680|NCT02014129|"~     The main purpose of this study is to evaluate safety and side effects of LY2835219 in~     Japanese participants with advanced cancer.~   "
118681|NCT02014116|"~     The main purpose of this study is to see how safe the investigational drug known as LY3009120~     is and whether it will work to help people with advanced cancer or cancer that has spread to~     other parts of the body.~   "
118682|NCT02014103|"~     Conduct a retrospective study to evaluate the impact of generic conversion in adult~     transplant recipients on post transplant outcomes one year prior to conversion to one year~     post conversion. Variables for analysis will include but not limited to incidence of~     rejection, hospital admission, changes in renal function, changes in transplanted organ~     function. All tacrolimus levels and dose changes during this period will be collected and~     compared. Additional pharmacokinetic modeling of this data will be performed for comparison.~      The prospective study will compare othe relative bioavailability and steady-state~     pharmacokinetics of 6 tacrolimus formulations in a prospective, 6-way cross-over study~     including CYP3A5 expressors (n=30) and non-expressor (n=30) transplant patients.~   "
118683|NCT02014090|"~     The purpose of this study in humans with stable coronary artery disease (CAD) treatable by~     percutaneous intervention (PCI) is to evaluate the efficacy of Enhanced External~     Counterpulsation (EECP) with regard to coronary collateral growth.~   "
118684|NCT02014077|"~     This is a prospective, randomized study comparing VATS( Video-Assisted Thoracoscopy ) to~     reinsertion of a Thoracostomy Tube in patients with retained haemothorax. The hypothesis is~     that early VATS as opposed to reinsertion of a thoracostomy tube , will lead to less~     complications and shorter hospital stay.~   "
118685|NCT02014064|"~     Methamphetamine (MA) abuse is a national public health concern. People who are dependent on~     MA have problems with mental functions (e.g., learning, remembering, focusing attention,~     solving problems). Such problems can interfere with their treatment for MA abuse, and thereby~     may promote continued drug use. While the effects of MA have been studied in rodents and~     non-human primates, its effects on the human brain have not been well characterized.~      This is a study of nontreatment seeking individuals who use MA compared to individuals who do~     not use MA(control participants). The study has three goals: 1. it aims to identify the brain~     regions and pathways that may contribute to the problems of MA abusers in performing mental~     tasks; 2. it will serve as a double-blind, placebocontrolled,within-subjects study to~     determine the safety and tolerability, and positive effects of MA in MA-abusing volunteers~     treated with atomoxetine or placebo; 3. It aims to compare the brain activity as measured by~     structuraland functional magnetic resonance imaging (fMRI). These are noninvasive brain~     imaging procedures, that will be used to study brain function while control and MA using~     participants take atomoxetine or placebo and perform tests of memory and concentration.~      MA abusing participants will undergo a 1-day outpatient screening and if it is safe for the~     participants to proceed with the study they will participate in two inpatient phases of the~     study that will occur in the UCLA research setting, the General Clinical Research Center. The~     first inpatient stay will be 15 days, and the second will be a 9 days stay that includes drug~     administration and assessments. There will be at least a two week interval between inpatient~     phases. During the inpatient phases participants will receive alternating study drugs;~     atomoxetine or placebo and four sessions of IV MA administration or placebo.~      The study schedule for control participants will include a 1-day outpatient screening and two~     phases of outpatient administration of atomoxotime or placebo with a two week study drug free~     interval between the phases. Four to five of the outpatient study visits will involve~     cognitive tests and brain imaging studies.~   "
118686|NCT02014051|"~     The purpose of this study is to investigate tolerability when SyB C-1101 is orally~     administered twice daily for 14 consecutive days to the patients with recurrent/relapsed or~     refractory myelodysplastic syndrome, to determine the dose-limiting toxicity and maximum~     tolerated dose, and to estimate the recommended dose for phase II studies. Pharmacokinetics~     and antitumor effects will also be investigated.~   "
118687|NCT02014038|"~     Health status information and physical activity level will be collected longitudinally on a~     large group of individuals who are ultramarathon runners at the time of enrollment to~     determine if very high levels of physical activity alter health risks compared with sedentary~     or moderately active lifestyles.~   "
118688|NCT02014025|"~     The purpose of this study is to compare short-term and long-term efficacy of laparoscope~     hepatectomy and open hepatectomy, evaluate the safety and efficacy of laparoscope hepatectomy~     the PHC with a tumor size of 5～10㎝,and provide class B evidence based medicine for~     laparoscope hepatectomy for PHC with a tumor size of 5～10㎝.~   "
118694|NCT02013947|"~     The metabolic syndrome is a cluster of metabolic disorders (obesity, hyperglycemia,~     dyslipidemia and hypertension) and it is a risk factor for the development of type 2 diabetes~     and atherosclerotic cardiovascular disease. There are several definitions for the metabolic~     syndrome. The AHA/NHLBI (American Heart association/National Heart Lung Blood Institution)and~     IDF (International Diabetes Federation)2009 criteria are frequently used to comparing data~     from studies. Prevention or reduction of obesity and lifestyle modification with physical~     activity is the main therapeutic goal in patients with metabolic syndrome. Recent studies~     have shown that exercise in moderate altitude or in moderate hypoxia improved glycemic~     parameters. The influence of training in moderate altitude on circulating metabolites and~     hormones in terms of substrate utilization is unclear. The adiponectin seems to play an~     important role in the homeostasis of adipose tissue and in the pathogenesis of the metabolic~     syndrome and physical activity seems to have a positive effect on adiponectin concentrations.~     In this study with randomized controlled pretest-posttest-design we want to investigate the~     effects of physical activity in moderate hypoxia on biomarkers of metabolic syndrome.~   "
118695|NCT02013934|"~     The objective of this study is to assess the benefit and tolerability of a probiotic product~     in subjects with increased susceptibility to common cold.~   "
118696|NCT02013921|"~     Many studies have demonstrated the beneficial effects of Adapted Physical Activity (APA) in~     different cancer types.~      It therefore seems necessary to assess spontaneous Physical Activity in order to integrate it~     to the overall calculation of physical activity in clinical practice.~      To assess the AP, two types of methods are validated : the subjective method using a~     questionnaries and objective method using a pedometer , accelerometer or measures calorimetry~     .~      Subjective method shows , good acceptability by patients and low cost but can sometimes lead~     to poor estimation of the level of activity.~      Objective methods obviously increase the accuracy of assessments but are more difficult to~     use for epidemiological studies , less accepted by the patient and more expensive.~      In this study the investigators will measure the spontaneous Daily Physical Activity by both~     methods andd evaluate the correclation.~   "
118697|NCT02013908|"~     Acupuncture is widely used for managing acute and chronic pain conditions. In the context of~     an emergency department (ED), patients often present with non-emergent acute pain symptoms.~     This may result in a delayed triage process and inefficient emergent management. An~     integrative patient-care approach in emergency departments has been explored that may improve~     patient satisfaction and promote efficient use of healthcare resources for non-emergent~     patients in the ED. This implies there is a potential role for acupuncture in such contexts.~     The aim of this pilot study is to assess the effectiveness and safety of acupuncture as an~     add-on intervention for patients with non-emergent acute musculoskeletal pain and primary~     headaches in an ED setting.~      Hypotheses of this study are as follows:~        1. A single session of add-on acupuncture, with standard ED management, can reduce pain~          levels in non-emergent acute pain, compared to standard ED management alone.~        2. A single session of add-on acupuncture to standard ED management can reduce additional~          consumption of healthcare resources for management of non-emergent acute pain, compared~          to standard ED management alone.~      This study aimed to include 40 participants, 20 in the acupuncture plus standard ED~     management group and 20 in the standard ED management alone group.~   "
118698|NCT02013895|"~     Preoperative evaluation of future remnant liver function is critical for patients undergoing~     hepatic surgery. Overestimation of the remnant liver function can lead to life-threatening~     postoperative hepatic failure, and its underestimation can lead to a lost opportunity for~     potentially curative surgery. Conventionally, post-hepatectomy remnant liver function has~     been estimated preoperatively using computed tomography (CT) volumetry. CT can provide~     precise anatomical information, and the remnant liver volume, measured by CT volumetry, has~     been reported to be an effective predictor of hepatic dysfunction after hepatectomy. However,~     the indirect estimation of liver function by CT volumetry is reliable only when the function~     is assumed to be homogenous over the whole liver.~   "
118699|NCT02013882|"~     We propose a new wash-in technique for desflurane low flow anesthesia with fresh gas flow of~     O2:N2O 1:1 L/min with desfluraene 12%.~      The objective of this study is to identify time to achieve alveolar concentration of~     desflurane at1, 2, 3, 4, 5 and 6%.~   "
118700|NCT02013869|"~     To study the Flow-I breathing circle during low flow general anaesthesia, whether this~     non-below system has advantages reduced time to reach Et 1MAC (minimal alveolar~     concentration) and lower consumption of inhaled agent~   "
118701|NCT02013856|"~     Fruit and vegetable rich diets are associated with a reduced risk of cardiovascular disease~     (CVD). The protective effect may be ascribed to compounds contained within these foods,~     called flavonoids. Flavanols (epicatechin and procyanidins) are a particular group of~     flavonoids and are found mostly in apples, berry fruits, dark chocolate, tea and red wine.~     There is evidence to suggest that ingestion of flavanol rich foods and beverages beneficially~     alter 'markers' of CVD risk (e.g. blood pressure). The aim of this study is to determine the~     acute and chronic effects of apple derived flavanols on some risk markers for CVD.~   "
118702|NCT02013843|"~     In the present study the effect of a community-based treatment of overweight and obese~     children is analyzed. The treatment-method is based on the principals and the method used in~     the Children Obesity Clinic in the Pediatric department i Holbaek. The effect is evaluated by~     the change in body mass index standard deviation score, change in blood pressure standard~     deviation score, quality of life and concentration of fasting blood lipids and glucose during~     one year of treatment.~   "
118703|NCT02013830|"~     This study will evaluate the efficacy and safety of oral Xeloda (capecitabine) plus~     intravenous Avastin (bevacizumab) in patients with advanced or metastatic liver cancer. The~     anticipated time on study treatment is 3-12 months.~   "
118704|NCT02013817|"~     This study will evaluate the efficacy and safety of intense combination treatment including~     MabThera/Rituxan (rituximab), followed by MabThera/Rituxan maintenance therapy in patients~     with B-cell CLL who are naive to chemotherapy. The anticipated time on study treatment is 2.5~     years.~   "
118705|NCT02013804|"~     This is a multicenter, open label, first-in-human dose-escalation study of MEDI0680 (AMP-514)~     to evaluate the safety, tolerability, PK, immunogenicity (IM), and antitumor activity in~     adult subjects with solid tumors.~   "
118711|NCT02013726|"~     Primary:~      In women with heterogeneous or dense breast tissue (mammographic types 3 and 4), MBI~     (Molecular Breast Imaging) will detect more breast cancers and have greater sensitivity in~     detecting breast cancer than breast tomosynthesis.~      Secondary:~        1. In women with heterogeneous or dense breast tissue, the specificity of MBI in correctly~          classifying subjects without breast cancer will be non-inferior to breast tomosynthesis.~        2. In women with heterogeneous or dense breast tissue, the area under the receiver~          operating characteristic (ROC) curve for MBI will be non-inferior or superior to breast~          tomosynthesis.~        3. Combining the use of MBI and breast tomosynthesis will provide performance superior to~          either technology alone, as manifest by a superior ROC curve area.~   "
118712|NCT02013713|"~     The Family Hypercholesterolemia remains poorly diagnosed disease with an outlet sometimes~     suboptimal care. However, the Family Hypercholesterolemia exposes patients concerned at~     increased cardiovascular risk.~      The frequency of familial hypercholesterolemia in cardiologic is little studied and remains~     unknown, and there is little data on the profile of patients, diagnostic methods and~     management.~      Main objectives:~        -  Establish a monitoring patients with hypercholesterolemia Family cardiology in France~        -  Characterize the Family hypercholesterolemia in cardiology, including assessing the~          frequency of the most severe forms, which are at higher cardiovascular risk.~   "
118713|NCT02013700|"~     This is a phase I, randomized, blinded, placebo-controlled 9 subjects pilot safety run-in~     followed by an additional 16 randomized subjects for a total of 25 subjects. In the pilot~     phase subjects will be randomized into three treatment groups of allogenic mesenchymal stem~     cells and in the randomized phase subjects will receive either allogenic mesenchymal stem~     cells or matched placebo.~   "
118714|NCT02013687|"~     This study is a Phase 1, dose escalation, first-in-human study designed primarily to evaluate~     the safety of the purified plant-derived Pfs25 VLP combined with Alhydrogel adjuvant~   "
118715|NCT02013674|"~     Thirty (30) patients with chronic ischemic left ventricular dysfunction secondary to MI~     scheduled to undergo cardiac catheterization will be enrolled in the study. This is a phase~     II study intended to gain additional safety and efficacy assessments among two dose levels~     previously studied in a phase I setting.~   "
118716|NCT02013661|"~     The aims of this study were to evaluate and compare tissue erythema, edema and knot loosening~     among four types of suture one week after periodontal surgery.~   "
118717|NCT02013648|"~     This is a randomized phase III open-label, multicenter trial evaluating standard induction~     therapy (daunorubicin [DNR] and cytarabine [Ara-C]) and consolidation therapy (high-dose~     cytarabine [HDAC]) with or without dasatinib in adult patients with newly diagnosed CBF-AML~   "
118718|NCT02013635|"~     Cerebral venous thrombosis is considered as a rare type of stroke with an annual incidence of~     3 to 4 per million people. It occurs generally in young patients (mean age of occurrence = 40~     years) and principally in young females (75%) generally in pregnancy or oral contraceptive~     use situations.~      The onset may be acute (less than 2 days), subacute (between 2 and 30 days) or chronic (more~     than 30 days). The clinical presentation is highly variable and includes patients with only a~     mild headache, others with focal neurological deficits and a few with a dramatic syndrome and~     a coma. Moreover the evolution can be very different with unpredictable outcome: more often~     it is favorable with a low mortality rate, but in some cases it can be a worse course. The~     aim of this study is to evaluate the correlation of some biological markers: thrombin~     generation test and D-Dimers (marker of fibrin generation and degradation) with the type of~     onset or the wide spectrum of clinical presentations or the different modes of evolution.~      All patients over 16 years ago may be included in the program when CVT diagnosis is proved by~     magnetic resonance angiography (MRA). For each included patient, there are four blood assays:~     the first just at the time of diagnosis and before the beginning of treatment, the second~     before the beginning of the oral anticoagulant treatment. The third assay is done in the~     third month at the time of a MRA. The last assay is made one month after the end of the~     anticoagulant treatment or in 12th month after the beginning of the disease if the treatment~     goes on.~      For each sample, the investigators perform a thrombin generation test and a D-Dimers~     measurement.~   "
118719|NCT02013622|"~     The purpose of this study is to investigate the effects of flexibly dosed Brexpiprazole~     monotherapy in the improvement of early-episode schizophrenia through the assessment of~     social functioning, efficacy, and tolerability. Early-episode schizophrenia is defined as~     episodes occurring ≤ 5 years after the onset of the first episode.~   "
118720|NCT02013609|"~     To investigate the efficacy and safety of flexibly dosed adjunctive brexpiprazole treatment~     in active adults with MDD, 18 to 35 years old, who are experiencing an inadequate selective~     serotonin reuptake inhibitor (SSRI)/serotonin norepinephrine reuptake inhibitor (SNRI)~     response in a school or work environment.~   "
118721|NCT02013596|"~     The purpose of this study is to compare the effect of TEAS pretreatment and treatment on~     hepatic and renal dysfunction induced by pneumoperitoneum in patients undergoing laparoscopic~     surgeries.~   "
118722|NCT02013583|"~     The purpose of this protocol is to create a registry for patients diagnosed with Glucose~     Transporter Type 1 Deficiency (G1D), or patients experiencing symptoms consistent with G1D~     but not yet diagnosed, to enter medical information for physicians and other health~     researchers to analyze to increase the understanding of G1D and any sub-diagnoses.~   "
118723|NCT02013570|"~     The purpose of the present study is the clinical assessment of the efficacy of preincisional~     peritonsillar infiltration of dexmedetomidine on postoperative pain relief in children~     undergoing adenotonsillectomy.~   "
118724|NCT02013557|"~     Purpose: The purpose of this study is to see whether a text-message reminder system will~     increase the number of women who complete their diabetes screening after delivery.~      Study Design: Prospective randomized control trial~      Hypothesis: Gestational diabetics will be significantly more likely to follow up with their~     postpartum screening for diabetes if they receive text-message reminders to set up their lab~     appointment compared to those who receive usual care.~   "
118725|NCT02013544|"~     The purpose of this study is to confirm the efficacy of intravaginal prasterone (DHEA) on~     symptoms of vulvovaginal atrophy due to menopause and to collect further data on subjects~     exposed to intravaginal DHEA in order to meet the ICH E1 guideline requirements.~   "
118727|NCT02013518|"~     A total of 200 home dwelling participants, who fulfil the inclusion criteria, Alzheimer's~     disease, will be recruited from three hospitals in Norway.~      The intervention is based on a standardized manual, and consists of 11 weekly one-hour~     sessions, which are organized into six thematic modules.~      The content of each session is specified by a treatment manual, which additionally consists~     of worksheets, suggestions for homework in between sessions and letters to the caregivers~     (the German manual: Werheid & Thöne-Otto, 2010; the Norwegian manual: Ulstein, Gordner &~     Tonga, not published). The treatment will be conducted by experienced health staff (nurses,~     psychologist, doctors) with formal training in Cognitive Behavioural Therapy, and knowledge~     about Alzheimer's Disease. Furthermore, the health staff will be familiarised with the manual~     before study inception, participate in a two-day training seminar and will regularly be~     supervised.~      The control condition will be offered treatment as usual at the participating the memory~     clinics.~      The hypothesis is that the participants in the intervention group will report less depression~     and increased self efficacy as compared with the control group.~      We conducted a pilot study with 10 patients, 5 in each group, from March to June 2013 to~     examine the feasibility of the study protocol and do want to include these patients in the~     study population.~   "
118728|NCT02013505|"~     The investigators hypothesised that a video based patient education will help patients~     understand the process of colon cleansing prior to a colonoscopy procedure and hence will~     result in clean colons that will may help physician perform a better quality examination.~   "
118729|NCT02013492|"~     This pilot trial studies propranolol hydrochloride in treating patients with locally~     recurrent or metastatic solid tumors that cannot be removed by surgery. Propranolol~     hydrochloride may slow the growth of tumor cells by blocking the use of hormones by the tumor~     cells.~   "
118730|NCT02013479|"~     Our aim is to investigate if selenium supplementation versus placebo adjuvant to the standard~     treatment with levothyroxine (LT4) in patients with autoimmune thyroiditis will lead to~     improved thyroid specific quality of life, and reduced autoimmune activity. The trial will~     include 472 participants (2 X 236) from four clinical trial sites.~   "
118731|NCT02013466|"~     In this study healthy older adults are requested to consume 4 different high-protein~     nutritional supplements. Each subject will visit the site 4 times and at every visit they~     will consume 1 of the 4 products after which a series of blood samples will be taken. The~     blood samples will be analyzed for amino acid bioavailability in the blood up to 4 hours~     after consumption.~   "
118732|NCT02013453|"~     The purpose of this study is to determine if the addition of proton pump inhibitors (PPIs) to~     standard chemotherapy can improve progression free survival in patients with head and neck~     cancer.~   "
118733|NCT02013427|"~     This study is designed to examine brain properties for placebo response in chronic back pain~     patients. The investigators have preliminary data indicating that, in blinded clinical trial~     studies with neutral instructions regarding treatment, chronic back pain (CBP) patients can~     be subdivided into placebo responders and non-responders, and these differences are~     PREDICTABLE a priori, by brain activity. The results imply that CBP placebo may have clinical~     utility and that its properties can be studied by human brain imaging techniques. In Phase I~     of the study, the investigators seek to identify brain imaging parameters that predict the~     propensity for the placebo response in an independent CBP cohort. In Phase II, the~     investigators will evaluate the interaction between placebo response and medication treatment~     in individuals stratified as placebo responders versus non-responders. This research is~     designed to critically assess the neurobiology of placebo analgesia for chronic pain in a~     partially-blind clinical trial.~   "
118734|NCT02013414|"~     The objective of the proposed study is to evaluate a new, molecular image directed,~     three-dimensional (3D) ultrasound guided biopsy system in human patients. The current biopsy~     uses ultrasound imaging as guidance. However, the procedure uses two-dimensional (2D)~     ultrasound images and has sampling errors thus some cancers can be missed from the standard~     2D image-guided biopsy. In this study, an FDA-approved ultrasound device will be used to~     obtain three-dimensional (3D) images of the prostate from a commercially available ultrasound~     scanner. The clinician can use the 3D images to guide biopsy, record the core location of the~     biopsy sites, and perform re-biopsy to the same sites in a patient follow-up examination.~     This system can also use images from magnetic resonance imaging (MRI) or positron emission~     tomography (PET) and then fuse PET or MR images with 3D ultrasound images to guide the needle~     to a suspicious tumor target as seen on MRI or PET. We think that this fusion targeted biopsy~     technology will help to improve the accuracy of the current systematic biopsy approach for~     prostate cancer detection.~   "
118735|NCT02013401|"~     The central aim of this study is to assess mother-infant communication via behavioral,~     physiological, and affective indices under conditions where distal stressors may not be~     directly detectable by the infant.~   "
118736|NCT02013388|"~     A study in healthy subjects to assess the safety, tolerability, and pharmacokinetics of~     N91115.~   "
118737|NCT02013375|"~     Related donor stem cell transplantation using the alemtuzumab/ TBI platform has been shown to~     be a safe strategy to cure severe sickle cell disease. However, due to a lack of suitable~     donors, many patients cannot benefit from this strategy. Alternative donor sources are~     desperately needed to fill this gap. Nearly all patients will have a haploidentical family~     member who would be able to donate. The use of post transplantation cyclophosphamide has~     greatly improved the outcome of haploidentical stem cell transplantation. The investigators~     propose to combine this with alemtuzumab/TBI conditioning.~   "
118738|NCT02013362|"~     Phase I portion:~      To evaluate the safety and tolerability of pralatrexate with concurrent vitamin B12 and folic~     acid supplementation in Japanese patients with relapsed or refractory PTCL and to determine~     the recommended dosage. Also, to evaluate pharmacokinetics.~      Phase II portion:~      To evaluate the efficacy, safety, and pharmacokinetics of the recommended dosage regimen~     determined in the phase I portion. The primary efficacy endpoint shall be objective response~     rate (ORR).~   "
118739|NCT02013349|"~     To evaluate the long-term safety and performance of the DESolve Novolimus Eluting~     Bioresorbable Coronary Scaffold System~   "
118740|NCT02013336|"~     This is a Phase 1 study of the combination of two drugs: MM-398 and Cyclophosphamide. The~     goal is to find the highest dose of MM-398 that can be given safely when it is used together~     with the chemotherapy drug Cyclophosphamide.~   "
118746|NCT02013258|"~     Individuals with Prader-Willi syndrome (PWS) have been found to have a deficit of~     oxytocin-producing neurons and decreased oxytocin receptor gene function, so the purpose of~     this study is to determine if oxytocin (OT) administration will improve some of the aspects~     of Prader-Willi syndrome that are particularly troublesome for children and their families~     (the insatiable appetite and social behaviors).~      The research questions are:~        1. Does intranasal oxytocin cause any side effects in children with PWS?~        2. Does intranasal oxytocin administration alter appetite or behaviors in PWS?~   "
118747|NCT02013245|"~     The purpose of this study is to test the safety and immunogenicity of MTBVAC as a potential~     substitute for BCG vaccination. BCG vaccination has indeed demonstrated its major limitation~     in inducing protection against tuberculosis (TB). Novel vaccines are essential to fight~     against the current world epidemics in tuberculosis and resistance to anti-TB drugs.~   "
118748|NCT02013232|"~     Hyperprolactinemia is a frequent consequence of treatment with typical antipsychotic agents~     and atypical antipsychotics such as risperidone. Recent studies have suggested that~     aripiprazole, a partial dopamine agonist, reduces the prolactin response to antipsychotics.~     Thus, we conducted this study to evaluate the dose effects of adjunctive treatment with~     aripiprazole on hyperprolactinemia in stable schizophrenic patients maintained with~     risperidone.~   "
118749|NCT02013219|"~     This open-label, multicenter study will assess the safety, tolerability, and pharmacokinetics~     of intravenous (IV) dosing of atezolizumab in combination with oral erlotinib or alectinib in~     participants with NSCLC.~      This study has two stages. In the erlotinib group, the combination treatment will be given to~     participants with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor~     (TKI)-treatment-naive, advanced (nonresectable) NSCLC in a safety-evaluation stage and to~     participants with previously untreated EGFR mutation-positive, advanced NSCLC in an expansion~     stage (Stage 2). In the alectinib group, for both the safety-evaluation and expansion stages~     (Stages 1 and 2), the combination will be given to participants who are treatment-naive with~     anaplastic lymphoma kinase (ALK)-positive advanced NSCLC.~      In Stage 1, erlotinib will be given at a starting dose of 150 milligrams (mg) by mouth (PO)~     once daily (QD) and the starting dose of alectinib will be 600 mg twice daily (BID), for 28~     consecutive days during Cycle 1 and on Days 1 through 21 of each cycle thereafter. The~     starting dose of atezolizumab will be 1200 mg, administered every 3 weeks (q3W) starting on~     Day 8 of Cycle 1. If the starting regimen for a combination treatment is not tolerated,~     alternative doses and/or schedules of erlotinib and atezolizumab or alectinib and~     atezolizumab may be tested to determine potential recommended Phase 2 dose (RP2D) for that~     combination treatment. In Stage 2, a potential RP2D and schedule for each combination~     treatment will be investigated in an expansion cohort.~      For both stages, continuation of treatment beyond Cycle 1 will be at the discretion of the~     treating investigator. Study treatment will be discontinued in participants who experience~     disease progression or unacceptable toxicity, are not compliant with the study protocol, or,~     in their opinion or in the opinion of the investigator, are not benefiting from study~     treatment. However, in the absence of unacceptable toxicity, participants with second-line or~     greater NSCLC who are still receiving atezolizumab at the time of radiographic disease~     progression may be permitted to continue study treatment. Time in the study is expected to be~     approximately 15 months.~   "
118750|NCT02013206|"~     This study will evaluate the efficacy and safety of Tarceva in two groups of patients with~     non-small cell lung cancer who have not been pre-treated with chemotherapy. One group,~     consisting of patients who have never smoked, will receive Tarceva 150 mg/day, and the other~     group, consisting of current/former smokers, will receive Tarceva 150 mg/day increasing to a~     maximum of 300 mg/day. The anticipated time on study treatment is 1-2 years.~   "
118751|NCT02013193|"~     The primary objective of this study is to prove the superior performance of the Ranger™~     paclitaxel-coated PTA balloon catheter for angioplasty for femoropopliteal artery lesions~     when compared to non-coated balloons at six months post-procedure when comparing Late Lumen~     Loss (LLL). Study statistical hypothesis: The %-mean loss of luminal diameter as assessed by~     angiography at six months follow-up after treatment of the femoropopliteal artery with Ranger~     DCB study devices is lower than the %-mean loss of luminal diameter after treatment with~     uncoated PTA balloon control devices.~   "
118752|NCT02013180|"~     Although Prostate Specific Antigen (PSA) is a useful marker for early detection of the~     prostate cancer, its specivity is not sufficient. Several PSA variations were defined in~     order to increase the specivity of the test, but they aren't much more effective than the PSA~     alone for detection of disease.~      In older studies reported that, serum and prostatic tissue zinc levels decreased in prostat~     cancer disease.~      In our study we aimed to establish the utility of serum zinc, PSA, free PSA/PSA (fPSA/tPSA),~     zinc/PSA, levels for early detection of the prostate cancer.~   "
118753|NCT02013167|"~     The primary objective was to evaluate the effect of blinatumomab on overall survival when~     compared to standard of care (SOC) chemotherapy.~   "
118754|NCT02013154|"~     A study to evaluate the safety and tolerability of DKN-01 in combination with weekly~     paclitaxel or pembrolizumab in participants with relapsed or refractory Esophagogastric~     Malignancies~   "
118755|NCT02013141|"~     This is a multicenter, open-label, single-dose pharmacokinetic (PK) study. Infants, children,~     and adolescents will receive a single 10 mg/kg dose of telavancin infused intravenously (IV)~     over 60 minutes~   "
118756|NCT02013128|"~     The purpose of this study is to evaluate the safety and effectiveness of Ublituximab in~     combination with Ibrutinib in patients with advanced hematologic malignancies.~   "
118757|NCT02013115|"~     Infants showing high local pulmonary inflammation diagnosted by respiratory distress syndrome~     usually need the second or more pulmonary surfactant and is easier to developing to~     Brochopulmonary. Cursurf is used worldwide in infants with respiratory distress syndrome,~     Budesonide is a glucocorticoid with a high local anti-inflammatory effect.Our hypothesis is~     Cursurf combined with Budesonide could reduced the need of Cursurf and incidence of~     Brochopulmonary dysplasia.~   "
118758|NCT02013102|"~     The purpose of this study is to evaluate of the safety and efficacy of decitabine treatment~     of Myelodysplastic Syndrome.~   "
118759|NCT02013089|"~     Hypothesis: Different patients have different biomarkers, if doctors know about the~     biomarkers of patients; they may be able to prescribe a regimen that is better suited to the~     patient's specific needs. This is a pilot study. Here, we used whole exon sequencing and~     Integrated genomic network analysis to identify the biomarker or gene. We aimed to learn if~     the drug chosen based on biomarkers can help to control metastatic gastrointestinal cancer~     who had failed from all standard and available regimens.~   "
118760|NCT02013076|"~     The aim of the prospective cohort study is to: (1) document the magnitude of response to oral~     corticosteroids administered to children presenting to the emergency department with moderate~     or severe asthma and (2) quantify clinically available potential determinants of the response~     to corticosteroids, such as age, gender, triggers of the index exacerbation, environmental~     tobacco smoke (ETS), gene polymorphisms, and their interactions.~   "
137916|NCT01762059|"~     This study will test the hypothesis that a wearable automated bionic pancreas system that~     automatically delivers both insulin and glucagon can improved glycemic control vs. usual in~     the outpatient environment.~   "
118761|NCT02013063|"~     A small proportion of patients with lung cancer present with a solitary pulmonary nodule~     (SPN). This is an important group of patients because if it is lung cancer, presentation as a~     SPN represents early disease, which following surgery has a high 5 year survival rate.~     However as not all SPNs are lung cancer it would be unethical to biopsy every case. Clinical~     guidelines recommend that SPNs should undergo an initial (FDG)-PET/CT scan, which may give~     more information about the SPN and may indicate if it is likely to be lung cancer. However in~     many cases it does not and current practice is to monitor the SPN with a series of CT scans~     over 2 years to look for changes or growth which may/ but not always indicate lung cancer. If~     no changes are observed over 2 years the SPN is considered not lung cancer. This is both~     expensive for the National Health Service (NHS) and worrying for the patient in terms of~     monitoring CT costs and delayed treatment due to length of time to diagnosis.~      This study examines the diagnostic capacity of using a different CT scan. Dynamic Contrast~     Enhanced -CT(DCE-CT). DCE-CT and FDG-PET/CT scans give different information about the SPN~     and the investigators will look to see if information from either scan or combined~     information from both scans may be better in the diagnosis of early stage lung cancer. The~     investigators will also undertake a review of previous studies that have used these scans and~     use data from both the review and the trial to look at the cost effectiveness of using DCE-CT~     in the diagnosis of SPN.~      The trial will recruit 375 people who have a SPN detected by a normal CT scan which requires~     a FDG-PET/CT scan. In addition they will receive a DCE-CT scan either on the same day or~     within three weeks of the FDG-PET/CT scan. This is the only extra procedure that will take~     place to normal NHS care, however we will collect clinical and outcome data over the next two~     years.~      The study is coordinated by Southampton University clinical trials unit. Recruitment between~     January 2013 - April 2016, from up to 14 UK sites. Data analysis and conclusions are expected~     by the end of 2018.~      The study is funded by the NIHR-HTA~   "
118762|NCT02013050|"~     To evaluate the safety and efficacy of SGX942 in patients receiving chemoradiation treatment~     for the treatment of head and neck cancer.~   "
118763|NCT02013037|"~     All individuals who receive a heart transplant are at risk for developing antibody-mediated~     rejection (AMR). An antibody is a protein produced by the body's immune system when it~     detects a foreign substance, called an antigen. The mechanism of an antibody is to attack an~     antigen. In antibody mediated rejection, antibodies will attack the transplanted heart,~     causing injury to the heart. The purpose of this investigation is to determine if a study~     drug, called Eculizumab (Soliris), prevents antibody-mediated rejection in patients with high~     antibody production and prolongs long-term cardiac transplant survival.~   "
118764|NCT02013024|"~     Randomized controlled trial (RCT) testing the hypothesis that vitrification is superior to~     slow freezing.~   "
118765|NCT02013011|"~     This study is to evaluate effects of recruitment maneuver in patients undergoing robotic~     assisted radical prostatectomy.~   "
118766|NCT02012998|"~     To evaluate the immune response to Hepatitis B virus in children who have been primed with~     HEXAVAC or INFANRIX HEXA 10 years ago.~   "
118767|NCT02012985|"~     The purpose of this study is to determine if Oxalobacter formigenes is effective at lowering~     urinary oxalate levels in patients with primary hyperoxaluria.~   "
118768|NCT02012972|"~     For national antiretroviral therapy (ART) programs, the most important health system goals in~     reducing morbidity and mortality among HIV-infection patients are to initiate treatment as~     early as eligibility criteria allow and to achieve the highest possible long-term retention~     of patients on ART. In South Africa, cohort data have consistently found high attrition among~     ART patients, with the combined cumulative outcomes of death and loss to follow up averaging~     25-40% over the first five years after ART initiation. Like many other middle income~     countries, South Africa also faces very high rates of non-communicable diseases (NCDs) and~     NCD risks. Despite this, there are virtually no studies looking at interactions between ART~     and NCDs, and none that have considered the effect of NCDs and NCD risk factors on achieving~     the second health system goal mentioned above: long term retention on ART.~   "
118769|NCT02012959|"~     The purpose of this trial is to demonstrate that tolvaptan effectively and safely increases~     and maintains serum sodium concentrations in children and adolescent subjects with euvolemic~     or hypervolemic hyponatremia.~   "
118770|NCT02012946|"~     This study wants to investigate the hemodynamic changes in cardiopatic patients undergoing~     major non cardiac surgery, during and after the continuous infusion of levosimendan or~     dobutamine.~   "
118771|NCT02012933|"~     Lambert-Eaton Myasthenic Syndrome (LEMS) is a rare autoimmune disorder which affects the~     nerve-muscle junction. The major symptoms of LEMS are progressive muscle weakness. Many~     patients experience other symptoms like dry mouth or impotence. Congenital Myasthenia (CM) is~     an inherited disorder with similar affects and symptoms.~      3,4-Diaminopyridine (DAP) is an experimental drug that has improved strength in some subjects~     with (LEMS). There are no other accepted treatments for LEMS and DAP has relatively few side~     effects.~   "
118772|NCT02012920|"~     The goal of this clinical study is to determine the safety, tolerability, pharmacokinetics~     and activity of Seviteronel, a lyase-selective inhibitor of CYP17, in patients with~     castration-resistant prostate cancer (CRPC).~   "
118773|NCT02012894|"~     Symptomatic Gastroesophageal Reflux (GER) is considered by many a contraindication to~     laparoscopic sleeve gastrectomy (LSG). However, of the few studies that have investigated the~     relationship between LSG and GER the majority reported only changes in symptoms and~     manometric data, while assessment of GER using 24-hour pH monitoring is lacking.~      The aim of this study is to evaluate the effect of LSG on GER in morbidly obese patients.~   "
118774|NCT02012881|"~     The purpose of this study is to determine the effect of a four months school-based physical~     activity intervention on cognition, academic achievement, physical activity and aerobic~     fitness in 12-15 year old adolescents.~   "
118775|NCT02012868|"~     Studies have shown high prevalence (60-94%) of obstructive sleep apnoea (OSA) among patients~     undergoing bariatric surgery.~      Fifteen studies are published investigating the effect of bariatric surgery on OSA. All of~     them conclude a highly positive effect on OSA by bariatric surgery and weight loss. However~     these studies are biased by a huge number of drop outs. The drop out rate in the studies are~     around 60 percent.~      The Investigators state that the prevalence of OSA among patients undergoing bariatric~     surgery in Denmark is high. The Investigators state that the effect of bariatric surgery is~     significant on severity of OSA. The Investigators state that we can perform a study without a~     huge number of dropouts.~   "
118783|NCT02012764|"~     This is a 12-month, prospective, observational cohort trial involving Primary Care Trusts~     (PCTs) wishing to take part in the study and the Early Arthritis Clinic (Anti-CCP sub-clinic)~     at Chapel Allerton Hospital. The approximate duration of subject participation will be 12~     months and the approximate total duration of the study will be 10 years. Patients who have~     not developed inflammatory arthritis within the 12 month period will have the opportunity to~     continue follow up within the clinic on an annual basis with additional visits as clinically~     indicated until the development of IA.~   "
118776|NCT02012855|"~     The increase in fat (i.e. triglyceride) in the blood after a meal is a well-established risk~     factor for heart disease (Nordestgaard et al. 2007). Endurance exercise is beneficial for~     improving the blood lipid response to a subsequent meal; that is, the appearance of fat~     (triglyceride) in the blood is less after a meal if endurance exercise was performed shortly~     before (i.e. within half a day) of the meal (Petit et al. 2003). This benefit of exercise is~     unfortunately negated if the after-exercise food choice to replace the calories expended~     during exercise is one containing high glycemic index carbohydrates. For example, if a high~     glycemic index carbohydrate is consumed after an evening exercise session, the exercise no~     longer has an effect of lowering triglyceride in the blood after a meal consumed the next~     morning (Harrison et al. 2009; Burton et al. 2008). Very rarely do people perform an exercise~     session and then fast until their next meal hours later. The more common practice is to~     consume food immediately after the exercise to enhance recovery and because hunger is~     stimulated with exercise. Consuming carbohydrate with a low glycemic index has been shown to~     reduce the level of fat in the blood following a subsequent meal (Gruendel et al. 2007). To~     date, no studies have examined the effects of consuming a low-glycemic index meal after~     exercise on the blood fat response to a subsequent meal. The specific objective of our~     research is to determine the effect of consuming low glycemic index lentils after an~     endurance exercise session on the blood fat (triglyceride) response to a subsequent meal.~     Twenty-five overweight or obese men will have their blood triglycerides measured four times~     over six hours after a high-fat morning meal following four different conditions, in a~     randomized, counterbalanced, cross-over design (i.e. the 25 subjects will each participate in~     all four conditions, where the order of conditions for each person is randomized): 1) After~     exercise (90 minutes of moderate intensity walking) is performed the evening before, followed~     by caloric replacement with a high-glycemic index meal (i.e. white bread and instant mashed~     potatoes); 2) After the same exercise is performed the evening before, followed by caloric~     replacement with a lentil-based meal; 3) After the same exercise is performed the evening~     before, followed by fasting; 4) After a no exercise/ no meal condition (i.e. control~     condition). In addition to measuring blood triglycerides we will measure blood insulin, free~     fatty acid, high density lipoproteins, low density lipoproteins, and glucose levels as these~     are also related to cardiovascular disease risk and may be altered with exercise and lentil~     consumption. We will also measure the muscle's ability to burn fat (i.e. fat oxidation) by~     assessing respiratory gases (oxygen consumption and carbon dioxide output) after the high-fat~     meal because we expect exercise and lentils to increase fat oxidation. Our expected results~     are that consuming lentils after endurance exercise will lower the blood triglyceride~     response to a subsequent meal compared to exercise alone or when high-glycemic index~     carbohydrates are consumed after the exercise.~   "
118777|NCT02012842|"~     The aim of this study is to evaluate the effect of periodontal treatment on systemic~     inflammation and quality of life of individuals with metabolic syndrome. There will be a~     randomized clinical trial with patients from the clinic of Endocrinology - Prediabetes~     (Hospital de Clinicas de Porto Alegre) and outpatient dental clinic of the Faculty of~     Dentistry, Federal University of Rio Grande do Sul (UFRGS), who have a diagnosis of metabolic~     syndrome and diagnosis of periodontitis. The clinical trial will consist of an arm where it~     will be immediately periodontal treatment (test group) and another arm which will be held~     later periodontal treatment (control group). The study will last six months , and after this~     period, the control group will receive the same treatment to the test group . A~     socio-demographic questionnaire will be applied by a trained interviewer , so that data on~     income, education , behavioral habits , medical and dental history . Complete periodontal~     examination will be conducted at 6 sites per tooth for all teeth present at baseline and 3~     and 6 months after periodontal treatment . In addition to the tests required for the~     diagnosis of metabolic syndrome , will be asked the same blood tests at 3 and 6 months after~     periodontal treatment (total cholesterol , LDL and HDL , fasting glucose , triglycerides ,~     C-reactive protein). Aliquots of plasma from blood collected in each experimental point are~     stored at -80 ° C for analysis of interleukin- 6, Tumor Necrosis Factor- α (TNF-α) , Glucagon~     Like Peptide-1 (GLP-1) and adiponectin. At each clinical examination will be collected~     gingival crevicular fluid , supra and subgingival biofilm . Versions of the questionnaires~     validated in Brazil (OHIP-14)and WHOQoL Bref will be applied to assess quality of life at~     baseline and after 6 months of the study . The primary outcome will be change in glycated~     hemoglobin and secondary outcomes will be changes in serum fibrinogen and C-reactive~     protein.The hypothesis of this study considers that periodontal treatment can alter the serum~     levels of C-reactive protein, fibrinogen and glycosylated hemoglobin in patients with~     metabolic syndrome and thereby contribute to improved quality of life. The objective of this~     study is to evaluate the effect of periodontal treatment on systemic inflammation and quality~     of life of individuals with metabolic syndrome.~   "
118778|NCT02012829|"~     Qualitative data were collected from 5 General Practionners (GPs) focus groups, 24 patient~     interviews and 35 recorded consultations from 9 GPs to explore colorectal cancer (CRC)~     screening in France The qualitative data indicated that improvement was needed in~     patient-centered communication. Educational material was developed based on these~     triangulated data with two different scenarios to improve communication with patients: one~     for a compliant patient, another for a non compliant patient The hypothesis is that a brief~     intervention on GPs can improve the patients' participation rate to colorectal screening~      Method : cluster randomized control trial (cluster unit : GPs practices) With a brief~     intervention on a randomized population of GPs in the district of Val d'Oise Inclusion~     criteria: GPs with a practice in the district of Val d'Oise and active in the colorectal mass~     screening~   "
118779|NCT02012816|"~     The Centre for Infectious Disease Research in Zambia (CIDRZ) and researchers from the~     University of North Carolina at Chapel Hill (UNC) have partnered to pilot an peer-referral~     incentive program to increase voluntary medical male circumcision (VMMC) uptake in Zambia.~     The program allows each man coming for circumcision to refer up to 5 uncircumcised men in~     their social network for VMMC services and receive a monetary reward for each successful~     referral. The peer-referral program offers several advantages over traditional~     demand-creation approaches that rely on employing mobilizers or community health workers~     (CHWs). The amount of the monetary incentive will be analogous to the amount of incentive~     that CHWs might receive for comparable effort, making the program suitable for large-scale~     expansion. The effect of the peer-referral program on uptake of VMMC services will be~     evaluated using a rigorous methodology proposed by UNC researchers.~   "
118780|NCT02012803|"~     The intention is to compare prospectively operative and conservative early functional~     rehabilitation protocol in treatment of total achilles tendon rupture. To compare these~     treatments, the investigators use 1998 published Leppilahti-score, Rand-36 quality of~     life-questionnaire and MRI. The Leppilahti-score includes both subjective and objective items~     (pain, stiffness, subjective calf muscle weakness, footwear restrictions, active range of~     motion between ankles, subjective result, isokinetic calf muscle strength). The investigators~     also study MRI-imaging for both legs and compare including achilles tendon elongation and~     muscle volume correlations to Leppilahti-score results between these two treatments.~     Follow-up time is 18 months.~      Hypothesis is that operative treatment offers no benefit in comparison conservative~     treatment, with identical rehabilitation protocol.~   "
118781|NCT02012790|"~     Migraine is a widespread, debilitating, chronic pain disorder and a major public health~     challenge. Most conventional, pharmaceutical treatments fail to give satisfactory long-term~     relief and their repeated use can have important side effects. This project involves~     implementation of substantial dietary changes in adults with migraine. Our goal is to test~     the hypothesis that a causal relationship exists between migraine symptoms and the amount and~     proportions of foods consumed containing defined amounts of polyunsaturated fatty acids.~      Significant findings supporting the hypothesis will lead to a major shift in both prevention~     and management of migraine and other chronic pain disorders. Emphasis is on low-cost, health~     improvement strategies utilizing specific dietary modifications for pain management, based on~     solid clinical research evidence.~   "
118782|NCT02012777|"~     Propanolol is a beta blocker which has been found to inhibit the ability of epinephrine to~     upregulate sickle red cell adhesion to laminin and endothelial cells in vitro. The purpose of~     this pilot study is to administer one dose of propanolol to children with sickle cell disease~     and to measure pre and post dose red cell adhesion. The hypothesis is that a single dose of~     propanolol will decrease red cell adhesion to laminin and endothelial cells as compared to~     baseline.~   "
118784|NCT02012751|"~     The Nevus doctor is a dermatoscopy based computer decision support tool to assist general~     practitioners (GPs) in the classification of pigmented skin lesions (PSLs). The aim of the~     program Nevus doctor is to help GPs increase their diagnostic accuracy, in particular~     regarding the selection of suspicious PSLs that need biopsy or referral to specialist health~     care for further assessment. The aim of this study is to investigate the diagnostic~     performance of the decision support tool in a primary care setting in Norway. We hypothesize~     that the diagnostic accuracy of the computer program Nevus doctor is better than the~     performance of the GPs.~   "
118785|NCT02012738|"~     Escalating violence is omnipresent in South African townships and can be traced back to two~     core mechanisms: a trauma-related hyper-arousal and a positive rewarding perception of~     violence. In the past, there was no therapeutic intervention available addressing both,~     trauma and the so-called appetitive aggression. The University of Konstanz has developed a~     culturally sensitive and scientifically based short-term intervention for the treatment of~     traumatized patients, the Narrative Exposure Therapy (NET), that has proven its effectiveness~     in various randomized clinical studies in different war-affected populations. Recently, the~     NET has been adapted for the forensic offender rehabilitation (FORNET) by also addressing the~     perpetration of violence related to a self-rewarding perception of the exposure with~     violence. It has shown to be effective in reducing the number of committed offenses in a~     perpetrator sample in Burundi and to reduce PTSD symptoms in a perpetrator sample in the~     Democratic Republic of the Congo. In this study, we investigated the therapeutic efficiency~     of FORNET in a randomized clinical control trial with a sample of former offenders of the~     townships of Cape Town. In addition to the previous studies, we specifically addressed the~     context of ongoing stress and linked our findings to epigenetic markers of stress and~     violence. Participants were followed over a period of up to 25-months post-treatment. The~     FORNET was also disseminated to local staff of our collaboration partners from the South~     African Universities and an organization working in the townships to warrant sustainability~     of the therapeutic intervention.~   "
118786|NCT02012725|"~     This study is a feasibility study to validate magnetizatin transfer (MT)-weighted balanced~     steady state free precession (bSSFP) cine cardiac magnetic resonance (CMR) against current~     clinical gold standard diagnostics, and to determine the applicability of MT-weighted bSSFP~     cine CMR for diagnosis of fibrotic remodeling in chronic kidney disease (CKD5) patients.~     Participants will not receive a study drug or placebo and will not be randomized. A total of~     250 participants will be enrolled into this study.~   "
118787|NCT02012712|"~     Purpose: To examine the impact of a personal health record (PHR) on medication use safety~     among older adults.~      Background: Online PHRs have potential as tools to manage health information. We know little~     about how to make PHRs accessible for older adults and what effects this will have.~      Methods: A PHR was designed and pretested with older adults and tested in a six-month~     randomized controlled trial. After completing mailed baseline questionnaires, eligible~     computer users aged 65 and over were randomized 3:1 to be given access to a PHR (n=802) or~     serve as a standard care control group (n=273). Follow-up questionnaires measured change from~     baseline medication use, medication reconciliation behaviors, and medication management~     problems.~   "
118788|NCT02012699|"~     The objectives of this project at UNMC and other IRB approved sites is to implement and~     maintain a comprehensive data and biospecimen bank known as the Integrated Cancer Repository~     for Cancer Research (iCaRe2). The data registry and biospecimen bank will provide core~     support services for future IRB approved multidisciplinary research on cancer and other~     chronic diseases carried out by members of the Fred and Pamela Buffett Cancer Center as well~     as internal and external research collaborators from different participating~     institutions/centers.~   "
118789|NCT02012686|"~     The purpose of tihs study is to determine whether transcutaneous electric nerve stimulation~     (TENS) during thyroidectomy is effective in the reduction of posterior neck pain after~     thyroidectomy.~   "
118790|NCT02012673|"~     Rationale:~      The combined data from 3 studies outside the Unites States investigating the Lung Volume~     Reduction Coil system (RePneu LVRC) showed statistically significant improvements in~     pulmonary function, exercise capacity and quality of life at both 6-Months and 12-Months post~     treatment. 24 months post treatment the improved pulmonary function and exercise capacity are~     slightly decreasing. Retreating the patient with the LVR coil system in other parts of the~     lung could potentially lead to new improvements in lung function, dyspnea, exercise capacity~     and quality of life and may reduce the rate of decline.~      Objective:~      To investigate the safety and feasibility of re-treating patients with severe Chronic~     Obstructive Pulmonary Disease (COPD) with the RePneu LVRC system.~   "
118791|NCT02012660|"~     The objective of this study is to explore the relationship between moderate to severe~     hyponatremia and heat.~   "
118792|NCT02012647|"~     The purpose of this study is to examine the brain changes in people with Parkinson's Disease~     (PD) after they get deep brain stimulation (DBS) surgery, compared with people who do not~     have Parkinson's Disease. Treatment of Parkinson's disease is often difficult and~     challenging. Deep brain stimulation is an established surgical treatment that is effective~     for the treatment of PD, but the details of why it helps are not known. In order to achieve~     maximum benefits from this treatment, it is important to understand how it changes the brain.~     Specifically, the investigators will study electrophysiology, which is the study of how the~     brain conducts electrical messages to the rest of the body. To do this, the investigators~     will use transcranial magnetic stimulation (TMS), which is a painless and non-invasive~     procedure. They will also conduct motor physiology experiments of the upper and lower limbs~     to collect data about skeletal muscle movement. The data from this study will help explain~     whether the electrical changes in the brain have any relation to the physical benefits~     patients with Parkinson's Disease sometimes receive from DBS surgery.~   "
118793|NCT02012634|"~     A Multi-center, III Phase,Randomized Controlled Clinical Study of Capecitabine Metronomic~     Chemotherapy After Standard Adjuvant Chemotherapy in Operable Triple Negative Breast Cancer~   "
118794|NCT02012621|"~     The purpose of this study is to evaluate cumulative exposure to tenofovir diphosphate~     (TFV-DP) using dried blood spots (DBS) in treated HIV-infected patients who are receiving a~     TFV-based regimen. Using DBS will allow the investigators to assess this simple method to~     measure drug exposure in the clinical setting. The investigators hypothesize that TFV-DP~     levels will be lowest in individuals with a detectable viral load and highest in those with~     viral suppression.~   "
118796|NCT02012595|"~     AIM: Investigate wether there are differences in the parasympathetic nervous system in~     Parkinsons patients compared to controls.~      MATERIALS AND METHODS: We use the tracer [11C]donepezil to image the parasympathetic nervous~     system. The Investigators will include 20 Parkinsons patients and 20 healthy controls aged~     40-80 in our study. The participants will receive a careful medical examination, including a~     neurological examination, as part of the inclusion process. The subjects also have an MRI~     scan of the brain. Then PET/CT scans with [11C]donepezil are conducted - once for the upper~     abdominal region and once for the head region. For evaluating the function of the~     parasympathetic nervous system gastric emptying time, heart rate variability and salivary~     flow will be measured. These measureless will be correlated to the PET findings.~      PERSPECTIVES: The study will potentially result in the development of a PET ligand for~     imaging the parasympathetic nervous system. This will have applications for research in~     Parkinson's disease, diabetes, heart disease and other disorders, in which the autonomic~     nervous system is involved~   "
118797|NCT02012582|"~     In the exploratory multi-center Phase 2 a study safety, tolerability, pharmacodynamics and~     pharmacokinetics of the Nitric Oxide Synthase inhibitor VAS203 is assessed in patients with~     moderate and severe traumatic brain injury. Traumatic brain injury patients (32 males)~     receive 15, 20 and 30 mg/kg VAS203, respectively, by continuous infusion in three cohorts~     (Cohort 1 open; Cohorts 2 and 3 double blind, randomised placebo-controlled). End of Study~     for all patients will be Day 14; adverse events and concomitant medications will be~     documented throughout the study.~      Objectives are to assess safety and tolerability of VAS203, to evaluate concentrations of~     metabolites of VAS203 in plasma and microdialysate and to assess pharmacodynamic effects of~     VAS203 on surrogate parameters. Safety parameter will include vital signs (blood pressure~     heart rate, respiration rate, oxygen saturation and blood gases), fluid balance, ECG,~     laboratory examinations (clinical chemistry, liver function, haematology/coagulation,~     urinalysis, renal parameters) and adverse events. Concentration of VAS203 will be determined~     in plasma and microdialysate. Pharmacodynamic parameters will include intracranial pressure~     (ICP), biochemical parameters in microdialysate (nitrite/nitrate, arginine, citrulline,~     pyruvate, lactate, glucose), Partial Oxygen Pressure in brain parenchyma and Therapy~     Intensity Level (TIL).~   "
118798|NCT02012569|"~     The purpose of this study is to determine the haemostatic efficacy of TT-173, reducing the~     bleeding time in the donor site of skin grafting.~   "
118799|NCT02012556|"~     The primary objective of the study is to determine the PK (tesamorelin) and PD (IGF-1)~     profiles of tesamorelin after a single 2 mg subcutaneous administration and after repeated~     administration once daily for 14 consecutive days. Secondary objectives include the~     evaluation of the safety and tolerability of tesamorelin following multiple subcutaneous~     injections.~   "
118800|NCT02012543|"~     The administration of agar jelly may increase the number of defecation and the volume of~     feces, and then may improve fecal condition in chronic constipated patients.~   "
118801|NCT02012530|"~     Study Title: A cohort comparison study Comparing Platelet Rich Plasma vs Hyaluronic Acid~     Intra-articular Knee Injections for Early Cartilage Defects in the knee.~      Study hypothesis: We start with the hypothesis that both treatments are equally effective.~      Trial Design: The participating patients will be divided into two groups, each group~     receiving either one of the treatment modalities. This study will be randomised. Both~     procedures will be done at the Spire Alexandra Hospital by Professor A. A Shetty. The~     post-operative rehabilitation process will be the same for both groups.~      Trial Participants: All participants will be from patients attending Professor Shetty's~     clinic at the Spire Alexandra Hospital.~      Planned Sample Size: 50 patients in each group~      Follow-up duration: The participating patients will be followed up at 2 weeks, 6 weeks, 3~     months following the surgery by visits to the clinic and assessed clinically. The surgical~     outcomes will be measured by by IKDC, KOOS and Lysholm scores.~      Planned Trial Period: Two to three years~      Primary Objective: To establish superiority, if any, of either procedure over the other by~     studying pain relief, improvement in function.~      Primary Endpoint: At the end of the 2 year follow up for all participating patients.~   "
118802|NCT02012517|"~     The added benefit of prolonged antibiotic prophylactic treatment in patients undergoing~     breast reconstruction who have drains placed for several days after surgery is controversial.~     In this study we aim to compare two prophylactic regimens: 1. 24 hour antibiotic treatment~     prior to surgery with cefazolin 2. a prolonged antibiotic regimen consisting of 48 hours~     cefazolin treatment followed by oral therapy with cephalexin until the removal of the drains.~     Patients will sign an informed consent form prior to the surgery and will be randomized to~     one of the antibiotic regimens. Patients will be closely followed up to one year after~     surgery. The number of surgical site infections according to the NNIS criteria and loss of~     breast implants will be compared between the two groups.~   "
118803|NCT02012504|"~     The primary objective is to evaluate the improvement of antidepressant monotherapy on~     depressive and anxiety symptom in Chinese patients who meet Diagnostic and Statistical Manual~     of Mental Disorders, Fifth Edition (DSM-5) criteria for the comorbidity of major depressive~     disorder (MDD) and generalized anxiety disorder (GAD)~   "
118804|NCT02012491|"~     The purpose of the study is to compare the effectiveness of combination treatment~     (mifepristone premedication plus single-dose misoprostol) to single-dose misoprostol~     (standard of care) for the management of early pregnancy failure.~   "
118830|NCT02012153|"~     The general aim of the present study is to test a cell therapy with autologous ex-vivo~     expanded mesenchymal stromal cells (MSCs) as a strategy to induce tolerance in living-donor~     kidney transplant recipients. MSCs will be prepared accordingly to established protocols,~     starting from bone marrow explants of living-donor kidney transplant recipients obtained 3-4~     months before kidney transplant. From these samples, MSCs will be expanded in Good~     Manufacturing Practice (GMP) approved facilities and used for the present study in patients~     undergoing kidney transplantation.~   "
118831|NCT02012140|"~     Ticagrelor therapy has been shown to reduce the rates of cardiovascular events and all-cause~     mortality compared to clopidogrel therapy in patients with acute coronary syndromes (ACS).~     The benefit of this study would be to demonstrate that ticagrelor therapy is associated with~     equivalent platelet inhibition irrespective of the disease status in patients undergoing PCI.~   "
118832|NCT02012127|"~     The purpose of this study is to describe most characteristic association of signs and~     symptoms present at the time of acromegaly diagnosis.~   "
118805|NCT02012478|"~     Despite advances in medical therapy for diabetes, significant numbers of patients fail to~     achieve adequate blood glucose control. Diabetic patients who engage in more self-care~     behaviors have better glycemic control, as measured by HbA1C. Patient activation, defined~     as the knowledge, skills, beliefs, and behaviors to manage a chronic disease, is key to the~     performance of these self-care behaviors.~      There is a growing literature on diabetes behavioral change interventions; however~     interventions are often developed and implemented without consideration of patients readiness~     to engage in lifestyle changes. Additionally, patient-tailored interventions require~     intensive clinical and financial resources, making them difficult to integrate into clinical~     practice. Mobile text messaging (SMS) programs have been successfully used to promote smoking~     cessation, alcohol cessation, and weight loss in diverse patient populations. SMS~     interventions for diabetes have also been developed, but they have been designed primarily to~     provide feedback on blood glucose management, rather than to motivate behavioral change. The~     few studies that included motivational content as a primary feature, did not tailor their~     intervention to a patient's readiness for change or rigorously describe their motivational~     intervention, and show limited efficacy.~      To address these concerns, we will perform a three-month randomized controlled pilot study to~     develop and test a Motivational Interviewing (MI)-informed SMS intervention tailored to~     patient level of activation for patients with poorly controlled type II diabetes.~   "
118806|NCT02012465|"~     There are no guidelines for the management of glucocorticoid- (henceforth steroid) induced~     elevated blood sugars (henceforth hyperglycemia). Oncology ward patients have particularly~     high rates of hyperglycemia and are frequently exposed to high dose steroid therapy. A prior~     study by Muthala et al. (unpublished data) found a relationship between insulin requirements~     needed to maintain normal blood sugars, patient weight, and mg of steroid administered. In~     this pilot study, through an endocrine consult team, a weight-based, steroid dose-based~     insulin protocol will be implemented for the management of hyperglycemia in lymphoma patients~     requiring high dose steroid therapy, with the goal of reducing hyperglycemia incidence.~   "
118807|NCT02012452|"~     The purpose of this study is to examine whether tobacco affects recovery from PTSD. There are~     3 goals of the study; (1) to test if quitting tobacco prior to PTSD treatment affects~     treatment success, (2) to test how PTSD symptoms change in those who have quit tobacco~     compared to those who continue to use and (3) to explore how tobacco use and tobacco~     withdrawal symptoms change during PTSD treatment.~   "
118808|NCT02012439|"~     Chronic pain is a pervasive, serious problem for many individuals with multiple sclerosis~     (MS) that is typically inadequately treated by medications alone. There is a critical need to~     develop and evaluate innovative psychosocial interventions that have the capacity to~     effectively target the multidimensional nature of MS pain. Cognitive Therapy (CT) is one~     psychosocial treatment that has been found to be a potentially beneficial treatment for~     chronic MS pain. This approach teaches patients to identify and replace unhelpful thoughts~     about pain with helpful, more adaptive thoughts. In addition, over the past decade there has~     been a steady upsurge of research examining mindfulness meditation-based therapies for the~     treatment of medical conditions, including symptoms associated with MS. Mindfulness mediation~     involves training the mind to disengage from automatic thinking patterns to mindfully~     perceive, in a non-judgmental manner, one's moment-to-moment experiences. This meditation~     technique teaches patients to become aware of thoughts, emotions, and physical sensations and~     to recognize that these are transient experiences that can be mindfully perceived, accepted~     and let go. A promising, more recent trend in treatment development research is the~     integration of tradition CT with mindfulness-based meditation, an approach referred to as~     Mindfulness-Based Cognitive Therapy (MBCT). To date, we are the only research group that has~     adapted and tested a manualized MBCT approach for the treatment of painful medical~     conditions. Thus, the proposed pilot randomized controlled trial aims to utilize~     state-of-the-art research methodology to evaluate traditional Cognitive Therapy (CT) compared~     to an innovative, newly developed Mindfulness-Based Cognitive Therapy (MBCT) protocol for the~     treatment of chronic pain in individuals with multiple sclerosis. This study will answer~     three primary questions: (1) Do these treatments work to improve chronic pain for individuals~     with MS and do these treatment also improve associated symptoms such as depression, fatigue,~     and engagement in daily activities?; (2) How do these treatments work in individuals with MS,~     i.e., what factors underlie improvement in outcomes during treatment?; and (3) What are the~     individual person characteristics that best predict outcome? This will be the first study to~     examine MBCT within an MS population. The results will lead to the emergence of a novel, much~     needed additional psychosocial treatment option for patients with chronic MS pain.~   "
118809|NCT02012426|"~     The aim of the current study is to demonstrate that a commercial weight management diet (i.e.~     low energy density) influences satiation, hunger and satiety and leads to lower energy intake~     during ad-libitum meals and over a full day. We further seek to demonstrate the~     sustainability of this effect following 12- week weight loss on the weight management~     program.~        -  We hypothesise that formulated (low energy) meals will lead to decreased hunger, greater~          fullness and reduced desire to eat compared to standard meals.~        -  We hypothesise that the commercial weight management program will lead to greater weight~          loss compared to control program.~        -  We hypothesise that formulated meals (high consumer acceptance) will improve hedonic~          control over eating (lower wanting for high fat food)~        -  We hypothesise that the commercial weight management program will improve hedonic~          control over eating (reduced experience food cravings)~   "
118810|NCT02012413|"~     PST (pulsed signal therapy) is a unique form of pulsed electromagnetic field therapy (PEMF)~     for stimulating healing of damaged structures such as cartilage, bones and soft tissues. The~     physical effect of the pulsed electromagnetic field (PEMF) has been focus of research in~     various studies, with cartilage being the most studied, and which has demonstrated an~     increase in the synthesis of proteoglican and collagen in vitro. This is an randomized,~     controlled and double blind clinical trial. The main objective is to evaluate clinical~     improvement regarding anterior knee pain after PST intervention in patients with patellar~     condropathy.~   "
118811|NCT02012400|"~     The purpose of this study is to assess the effects of regular exercise on physical fitness,~     asthma control, and quality of life among adult asthmatics.~   "
118812|NCT02012387|"~     To demonstrate the efficacy and safety of Omalizumab in a new indication, that is cholinergic~     urticaria.~   "
118851|NCT02011880|"~     The purpose of this clinical research study is to learn if the clinical effects of combined~     Chinese herbal medicine with endocrine therapy is better than endocrine therapy alone in~     improving the quality of life and shrinking and slowing the growth of the cancer in women~     with breast cancer bone metastasis.~   "
118971|NCT02010307|"~     aggressive periodontitis is an inflammatory disease which damage the teeth supporting~     structures mostly in young patients. and has genetic basis.~      a specific bacteria: Aggregatibacter actinomycetemcomitans (Aa) is associated with this~     disease, and found to damage leukocytes by using a specific leukotoxin.~      in the research the investigators are aiming to find molecular and immunological basis to~     aggressive periodontitis.~   "
118813|NCT02012374|"~     In this study the investigators are examining the effectiveness of intensive speech therapy~     in chronic moderate-to-severe stroke-induced aphasia under two conditions - responses~     constrained or unconstrained to speech. Both treatments involve massed practice~     communicating, using intensive language action therapy 3 hours/day, 5 days/week for two~     weeks, followed by six months of a home practice program. One treatment stresses spoken~     responses as the preferred expressive modality during intensive therapy. Before and after~     treatment, and following the home practice program and a period of no practice, the~     investigators will administer several tests and discourse samples to examine changes~     associated with the treatments. Participants will also undergo structural and functional MRI~     testing at these time points. The investigators will also attempt to quantify the degree to~     which improvements following intensive language therapy and home practice correlate with~     changes in Quality of Life measures as perceived by both participants with aphasia and their~     significant others. It is hypothesized that, whereas both treatments will lead to~     improvements in naming practiced words and communicating, outcomes will be enhanced for the~     group randomly assigned to the constraint condition. Moreover, performance will be enhanced~     on words practiced during the home practice program, including those that were not practiced~     during intensive therapy. Improved naming will correlate with modulation of 'signature'~     language and attentional networks, whose variability will depend on remaining viable brain~     structures. Initial severity and site/extent of lesion should predict patients' ability to~     transfer gains in naming to improvements in discourse.~   "
118814|NCT02012361|"~     The purpose of this study is to determine whether breathing in helium reduces indications of~     injury to the skeletal muscle seen in blood tests after knee replacement surgery.~      The ability to reduce the risk of skeletal muscle injury may help improve patient safety by~     providing protection to the area of the body having its blood supply interrupted during a~     particular surgery.~   "
118815|NCT02012348|"~     This study will recruit up to 10 healthy volunteers. An avirulent strain of S. pyogenes will~     be applied to their forearms after washing each of their forearms with different types of~     soap, one with an antimicrobial compound, and the other without an antimicrobial compound.~     After several hours of incubation, the subject's forearms will be swabbed for bacteria. The~     forearms will then be cleansed with antibacterial soap and water followed by 70% ethanol. The~     bacterial swabs will be analyzed and compared between the different soaps that were used to~     cleanse each digit prior to the application of S. pyogenes. The investigator expects the~     number of bacteria surviving on the skin of forearms washed with antimicrobial soaps will be~     fewer than with control soap.~   "
118816|NCT02012335|"~     The purpose of this study is to determine whether combination of ketamine plus~     electroconvulsive therapy improves depressive symptoms decreasing cognitive side effects.~   "
118817|NCT02012322|"~     Goal: The investigators propose to test the feasibility of giving the supplement coenzyme Q10~     (Q10) improves symptoms and subjective health in an aging population.~      Rationale: Direct empirical evidence has supported benefit of Q10 to many symptoms such as~     fatigue, muscle pain, and cognition. In addition, Q10 has also been reported to benefit other~     symptoms including headaches, sleep disturbances, and breathing problems. This provides a~     strong rationale for testing whether Q10 will have similar benefit to these symptoms in an~     aging population.~      Method: 44 aging subjects will participate. The design is a 9 month, randomized,~     double-blind, placebo-controlled crossover study. Each subject will be crossed over between~     high dose Q10 (300mg), low dose Q10 (100mg), and placebo, receiving each agent for 3 month~     periods. Neither subjects nor investigators will know which substance each subject is~     receiving in which phase. Subjects will be randomly assigned to one of six arms.~      Assessments: Assessments will include feasibility of study, subjective quality of life,~     energy, and metabolic and lipid panels. Analyses will show whether Q10 led to improvements~     when compared to placebo; whether higher Q10 doses improved outcomes more than lower doses;~     and whether people with certain symptoms or characteristics get more benefit than people with~     other symptoms or characteristics.~   "
118818|NCT02012309|"~     HIV infection is complicated by high rates of infections and cancers which are often the~     cause of death rather than the HIV/AIDS virus itself. Treatment of HIV with antiretroviral~     medications has decreased the frequency of many complications by over 90%, but bacterial~     pneumonia remains extremely high. Current vaccines are not very effective in preventing these~     infections in patients with HIV infection. The investigators are studying the cells (B cells)~     that make antibodies to fight infection by binding to and killing bacteria. The goal is to~     understand how HIV impairs the ability of B cells to make antibodies in sufficient quantity~     and of sufficient quality to protect patients with HIV to learn how to enhance protection~     against these infections. The investigators also seek to understand the role of the bacteria~     (specifically Streptococcus pneumoniae) that normally live in the nose and throat in the~     development of pneumonia and other infections.~   "
118819|NCT02012296|"~     This partially randomized phase I/II trial studies the side effects and best dose of~     enzalutamide and mifepristone when given together and to see how well they work in treating~     patients with metastatic hormone resistant prostate cancer. Androgens can cause the growth of~     prostate cancer cells. Antihormone therapy, such as enzalutamide and mifepristone, may lessen~     the amount of androgens made by the body. It is not yet known whether enzalutamide is more~     effective with or without mifepristone in treating patients with prostate cancer.~   "
118820|NCT02012283|"~     This study is being done to determine the differences in liking of vegetables between~     individuals based on a variety of variables, and to see if flavoring various vegetables~     differently with spices changes the intake of those vegetables.~   "
118866|NCT02011685|"~     This study will assess the comparative effectiveness, cost-effectiveness and sustainability~     of two telemonitoring interventions in reducing blood pressure and recurrent stroke among 450~     high-risk Black and Hispanic stroke patients. The primary hypothesis is that home blood~     pressure telemonitoring supplemented with individualized, culturally tailored telephone-based~     nurse case management will have greater effects on blood pressure reduction and stroke~     recurrence and, while it will be more costly, it will also be more cost-effective than home~     blood pressure telemonitoring alone. Results of this study will provide strong empirical~     evidence to inform clinical guidelines and practice, which may lead to reductions in stroke~     disparities in the United States.~   "
118821|NCT02012270|"~     Principles= Prevention of incision hernias by primary closure of mid line laparotomies with~     the best-evidenced suture techniques.~      Background:~      Surgical practice of abdominal wall closure continues to rely largely on tradition rather~     than high-quality level I evidence. Incisional hernia after laparotomy for treatment of~     abdominal aortic aneurysm (AAA) has a high incidence.~      At this moment the best results in a prospective randomised clinical trial considering~     incision hernia rates and wound infections, have been reported by the surgeons from the~     Sundsvall clinic in Sweden. Their technique using a suture to wound length ratio of at least~     4/1 and using many small stitches will be described in the protocol as the Principles~     Technique. We want to explore if these results can indeed prevent incision hernias~     significantly if implemented with training and tutoring.~      Methodology:Vascular surgeons,who are not using the principles yet, but show an interest to~     learn the Principles, will be asked to monitor a cohort of AAA patients using their current~     sutures and surgical techniques. Some of the vascular surgeons will undergo training and if~     wanted, proctoring during the first procedures using the Principles. A cohort of 120 AAA~     patients will be closed according to the Principles and monitored. The results of these 120~     patients will be compared to the control group consisting of patients closed with the~     conventional technique by non--‐trained surgeons. Primary endpoint:The incidence of incision~     hernias at 12 months will be determined by clinical examination.~      Data management and ownership:~      The data will be collected on a paper form and will be introduced is a database (SPSS~     Statistics, IBM) from which statistical analysis will be made.~   "
118822|NCT02012257|"~     AMSA nerve block injection is targeted anterior superior alveolar nerve and middle superior~     alveolar nerve branches of infraorbital nerve through nutrient canals. Therefore, central to~     second premolar teeth of one quadrant can be anesthetized. The aim of the present study was~     to evaluate the efficacy of AMSA nerve block injection at an anterior and a posterior~     positions compared to commonly administrated site.~   "
118823|NCT02012244|"~     The purpose of this study is to compare postoperative immune function (e.g. NK cell activity)~     of fentanyl-based analgesic regimen versus local anesthetic wound infiltration-based~     anlagesic regimen after laparoscopic colorectal surgery~   "
118824|NCT02012231|"~     The study objective is to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics~     (PD) of orally administered PLX8394 in patients with advanced solid tumors. An additional~     objective is to identify a Recommended Phase 2 (RP2D) for further evaluation in the Extension~     Cohorts (Phase IIa portion).~      The study objective of the Extension Cohorts (PART 2 portion) is to assess the objective~     tumor response and the PK, PD, and safety of PLX8394 when the RP2D is used in patients with~     advanced BRAF-mutated cancers.~   "
118825|NCT02012218|"~     The objectives of this exploratory trial are to evaluate the efficacy, safety, and subjects'~     subjective satisfaction when switching to adjunctive brexpiprazole in subjects with MDD who~     have responded inadequately to preceding adjunctive drug therapy.~   "
118826|NCT02012205|"~     Background: Persistent nonspecific low back pain (PNSLBP) is one of the most common low back~     pains worldwide. Many interventions were tried including wet cupping which is commonly used~     for pain conditions in Saudi Arabia and other parts in the world but without solid scientific~     evidence.~      Aims: This study aims at determining safety and efficacy of wet cupping for treating PNSLBP.~      Methods: This is a randomized wait-listed controlled clinical trial. Eligible patients with~     history of at least 3 months of PNSLBP will be randomized in to two groups, 45 patients each.~     The first group will be given wet-cupping treatment at two acupuncture points of urinary~     Bladder (BL) meridians among the BL23, BL24 and BL25, 6 times within 2 weeks. The second~     group will serve as a control group. Usual care, including providing brochures for exercise,~     general advice for PNSLBP and acetaminophen, will be allowed in both groups. Separate~     assessors participated in the outcome assessment. Investigators will use the 0 to100~     numerical rating scale (NRS) for pain, the McGill Pain questionnaire for pain intensity (PPI)~     and the Oswestry Disability Questionnaire (ODQ), and to assess acetaminophen use and safety~     issues.~      Expected Results: To provide data on the safety and effectiveness of wet cupping in treating~     PNSLBP and open the way for integrative medicine in Saudi Arabia~   "
118827|NCT02012192|"~     Epithelial ovarian cancer (EOC) is the most lethal gynaecological malignancy causing 41900~     deaths annually in Europe. The predominance of aggressive Type II tumours, which are~     characterised by a high frequency of p53 mutations, and primary or acquired resistance to~     platinum-based chemotherapy profoundly contribute to the high mortality rate. With current~     standard therapy the median overall survival of metastatic platinum-resistant (Pt-R) ovarian~     cancer patients is only 14 month. There is a pressing need for more effective, innovative~     treatment strategies to particularly improve survival in this subgroup of EOC patients. This~     is a drug strategy targeting a central driver of tumour aggressiveness and metastatic~     ability, namely mutant p53, via an innovative new Hsp90 (heat shock protein 90) inhibition~     mechanism. The most advanced, second-generation Hsp90 inhibitor will be used, Ganetespib. The~     first part (Phase I) of the GANNET53 trial will test the safety of Ganetespib in a new~     combination with standard chemotherapy (Paclitaxel weekly) in Pt-R EOC patients. The second~     part (randomised Phase II) will examine the efficacy of Ganetespib in combination with~     standard chemotherapy versus standard chemotherapy alone in EOC patients with Pt-R tumours.~   "
118828|NCT02012179|"~     SODIUM-HF is a multicenter clinical trial in ambulatory patients with chronic HF to evaluate~     the efficacy of a low sodium containing diet on a composite clinical outcome composed of of~     all-cause mortality, cardiovascular hospitalizations and cardiovascular emergency department~     visits. The hypothesis of this study is that patients following a low-sodium containing diet~     will have fewer clinical events (fewer hospital readmissions or emergency department visits,~     longer survival) than those randomized to Usual Care.~   "
118829|NCT02012166|"~     This is a study to assess the pharmacokinetics, safety, and tolerability of sequential single~     oral doses of MK-8093 10 mg, 40 mg, 200 mg, or placebo to MK-8093 (Part 1) depending on~     treatment assignment in young healthy male participants. In Part 2 of this study, sequential~     single oral doses of MK-8093 200 mg, 1000 mg or placebo to MK-8093 depending on treatment~     assignment will be evaluated. The primary hypothesis of the study is that at least one dose~     of MK-0893 will produce greater reduction of glucagon-induced glycemia as compared to placebo~     following the infusion of glucagon, Sandostatine®, and basal insulin.~   "
118833|NCT02012114|"~     Preventing late onset of Cystinosis such as neurological complications and improving~     compliance to cysteamine treatment remain major challenges in management of subjects with~     cystinosis.~      This study is designed to describe the relationship between compliance of patients with~     cystinosis treated with cysteamine and treatment efficacy and to understand the~     pathophysiologic mechanism of neurological disorders. Is cysteamine crossing the blood brain~     barrier? What is the impact of cystine accumulation in Cerebro Spinal Fluid and Central~     Nervous System? Our Primary objective is to study the relationship between compliance of~     patients treated with cysteamine and the WBC cystine level.~      Secondary, the study will assess relationship between compliance to cysteamine and its~     neurological consequences.~      The expected duration of the study is 48 months. The enrolment period is 24 months and the~     study participation of each subject is 24 months. Eligible participants are male and female~     (age > 4 years) with confirmed diagnosis of cystinosis and receiving any oral cysteamine~     treatment: Cystagon or RP103.~      The compliance under cysteamine is measured using electronic devices, accountability of study~     treatment, and information in patients' diary. Specific memory and visuoperceptual tests are~     performed at the beginning and at the end of patients'participation. Nuclear Magnetic~     Resonance spectroscopy is used to detect possible sites of cystine accumulation in the CNS~     and their relationship with compliance to cysteamine treatment. NMRS is also used to~     establish a relationship with the neuropsychological status of the subject.~      To describe absorption, distribution and elimination of cysteamine, and its metabolic~     pathways, and to determine the concentration effect and dose effect relationship, blood~     samples are performed at each study visit. A lumbar puncture is also proposed to participants~     to verify if cysteamine is crossing the blood brain barrier. New tools are used to compare~     metabonomic networks in patients with cystinosis and their controls.~   "
118834|NCT02012101|"~     The purpose of this study is to determine whether non-invasive mechanical ventilation(NIV),~     playing the role as a rescue therapy , are effective in relieving exertional dyspnea in~     stable severe COPD patients.~   "
118835|NCT02012088|"~     The Phase II study proposed here assesses the hypothesis that replacing doxorubicin by~     Myocet® in the R-CHOP regimen would yield comparable antitumour efficacy with a lower~     cardiotoxicity for first-line treatment in elderly patients with non-localised~     DLBCL/Follicular lymphoma grade IIIb~   "
118836|NCT02012075|"~     The aim of present study is to evaluate the efficacy and safety of Extended-Release~     Carvedilol Sulfate versus Sustained-release Metoprolol Succinate in Patients With Mild or~     Moderate Chronic Heart Failure.~   "
118837|NCT02012062|"~     The study is to evaluate whether concurrent nimotuzumab could decrease the severe acute~     treatment-related toxicities compared with concurrent chemoradiotherapy for locoregionally~     advanced NPC. Three hundreds and twenty patients will be recruited into this study.~   "
118838|NCT02012049|"~     The purpose of this study was to conduct the bioequivalence (biological equivalence of two~     preparations of a drug) test in healthy adults with Risperdal OD Tab. 2mg of Janssen Korea~     as the investigational drug and Risperdal Quicklet Tab. 2mg as the control drug.~   "
118839|NCT02012036|"~     The purpose of the study is to assess additional detection of Non-Muscle-Invasive Bladder~     Cancer (NMIBC) with hexyl aminolevulinate (HAL) cystoscopy based on lesions in patients~     undergoing TUR-B compared to white-light cystoscopy under the conditions of daily clinical~     practice.~   "
118840|NCT02012023|"~     Most surgeons suggest the use of fecal diverting to address the high morbidity and mortality~     associated with anastomotic leakage (AL) in patients with high risk factors on AL who are~     undergoing low anterior resections(LAR). This exploratory study was conducted to evaluate the~     efficacy and safety of one kind of controllable tube ileostomy(CTI), which was designed to~     protect rectal anastomosis in patients with high risk factors on AL. Results of SCCI were~     compared to those of the loop ileostomy (LI) method.~      In fact when we told the patients about the tube ileustomy's effect and risk, almost all the~     almost all of my patients like to choose tube ileustomy(I have study this method for long~     time and have good expeience, and my patients either choose tube ileostomy directly or let me~     do the choice.) So I gave all the patients who meet the requirenments all tube ileustomy and~     have no control group.~   "
118841|NCT02012010|"~     This study is to perform a randomized controlled trial of comparing the manual syringe~     infusion method with the conventional pump infusion method to clarify if the manual syringe~     infusion method really needs less amount of distension medium.~   "
118842|NCT02011997|"~     This is a Prospective, open-label, parallel, multi-center, Phase III randomized trial to~     evaluate the efficacy and safety of video-assisted thoracoscopic segmentectomy versus~     Lobectomy in treating patients with Lung adenocarcinoma in situ or with microinvasion.~   "
118843|NCT02011984|"~     Non-randomized multicenter post-market study to confirm the long-term safety and~     effectiveness of the CE-approved Camouflage-coated self-expandable RESISTANT Camouflage stent~     system for revascularization of de novo stenotic lesions in the superficial femoral artery in~     100 compliant patients suitable for stent angioplasty.~      The CE-approved device will be used according to its intended use. Beyond the standard of~     care no further interventions are scheduled. Therefore, this trial is subject to the~     exception to the rule §23b of the German Medical Device Act (MPG), which includes the~     national implementation of EC directive 93/42/EEC.~   "
118844|NCT02011971|"~     Pilot studies in healthy volunteers and in patients with epilepsy to assess the potential~     efficacy and safety of different dosages of vinpocetine in improving cognition.~   "
118845|NCT02011958|"~     The overall objective of this trial is to identify a safe and effective treatment for~     visceral leishmaniasis (VL) in HIV co-infected Ethiopian patients.~      Patients will receive either Ambisome alone or Ambisome in combination with Miltefosine.~      Patients who do not undergo treatment failure will be given a VL prophylactic treatment with~     Pentamidine one month after the end of the study treatment.~   "
118846|NCT02011945|"~     The purpose of this study is to find a dose of Nivolumab that can be safely added to~     Dasatinib in patients with Chronic Myeloid Leukemia.~   "
118847|NCT02011932|"~     The purpose of this study is to determine the progression of chronic hepatitis C patients~     infected by paid plasma donation,and explore the possible pathogenic mechanisms of disease~     progression in chronic hepatitis C.~   "
118848|NCT02011919|"~     This is a monocenter, open-label, uncontrolled study in accordance with §23b MPG to evaluate~     the efficacy of the HIFU-treatment of fibroadenoma using the TH-One device~      Objectives Primary objective: To evaluate the efficacy of HIFU in the treatment of the breast~     fibroadenoma using the TH-One device Secondary objective: To evaluate the tolerability of the~     HIFU using the TH-One device~   "
118849|NCT02011906|"~     The aim of this study is to determine the effects of omega 3 supplementation and its~     concurrent supplementation with vitamin E on the serum levels of antioxidant enzymes and the~     expressions of the PGC-1a, h TERT, FOXO1, FOXO3a , SIRT1,SIRT3, SIRT6 genes in PBMC cells in~     the patients with coronary artery disease~   "
118850|NCT02011893|"~     The purpose of the study is to demonstrate the safety and efficacy of the Prodigy system for~     the treatment of chronic intractable pain of the trunk and/or limbs.~   "
118852|NCT02011867|"~     The custom made device was produced by Med-El Company. It has a cork like stopper instead~     of the usual silicon ring to prevent gusher. There are two types of electrodes consisting of~     different length. Standard one is 25 mm (contact space 1.7 mm) and the short one is 20 mm~     (contact space 1.3 mm). It was used in 50 patients with different inner ear malformations.~     Thirteen patients had gusher, and 11 patients oozing during cochleostomy. One patient with~     initial prototype of the cork electrode had to be revised because of persistent oozing around~     the electrode. Another patient had slow extrusion of the electrode most probably due to CSF~     (cerebrospinal fluid) pulsation and had to be revised. Both patients had no more CSF fistula.~      CSF fistula in inner ear malformations is a serious situation which may lead to recurrent~     meningitis. The new cochlear implant electrode with cork stopper looks promising in~     preventing the postoperative CSF leak around the electrode.~   "
118853|NCT02011854|"~     Shoulder-hand syndrome，a common complication of stroke patient，which is an important factor~     of limb function recovery.This research aims to observe the effect and safety of Acupuncture~     and Traditional Chinese medicine Combined with Rehabilitation Therapy for Post-stroke~     Shoulder-hand Syndrome.Furthermore, the investigators will promote the treatment in community~     hospital.~   "
118854|NCT02011841|"~     The aim of this study is to evaluate whether long-term rifaximin administration reduces~     spontaneous bacterial peritonitis recurrence rate in cirrhotic patients.~   "
118855|NCT02011828|"~     The objective of this study is to determine the effects of cholecalciferol treatment on~     inflammation and insulin resistance, in patients on hemodialysis that are previously treated~     with paricalcitol.~      Cholecalciferol is produced by the action of sunlight on a cholesterol precursor in the skin.~     This compound is then converted to calcidiol (25(OH) D3) in the liver, whereupon calcidiol is~     converted in the kidney to calcitriol (1,25(OH)2D3), the active form of vitamin D. However,~     recently it has been shown that deficiency of either calcidiol or calcitriol is associated~     with inflammation, insulin resistance and increased mortality in the general population.~     Furthermore, when both calcidiol and calcitriol were deficient, the mortality risk was much~     higher than the deficiency of either alone. A possible explanation is that some of the~     non-renal tissues might critically depend on the endogenous conversion of calcidiol to~     calcitriol and not on circulating levels of calcitriol. Thus, low circulating levels of~     calcidiol might be associated with tissue level functional calcitriol deficiency despite~     adequate circulating levels of calcitriol.~      Therefore, the hypothesis is that:~        1. In non-diabetic hemodialysis (HD) patients treated with therapeutic doses of~          paricalcitol (an analog of calcitriol), calcidiol deficiency is associated with~          inflammation and insulin resistance and~        2. In calcidiol deficient, non-diabetic HD patients with inflammation and treated with~          therapeutic doses of paricalcitol, cholecalciferol will reverse the calcidiol deficiency~          and thereby, reduce inflammation and insulin resistance.~      Interleulin-6 (IL-6) is thought to play a central role in insulin resistance by~     down-regulating glucose transporter-4 messenger RNA. Furthermore, IL-6 levels are~     significantly negatively associated with calcidiol levels, therefore will be measured as the~     primary outcome.~   "
118856|NCT02011815|"~     The purpose of this study is to explore the possible association between the circadian~     disruption and cancer progression.~   "
118857|NCT02011802|"~     Sinus pilonidal concern 26/100 000 young adults. It manifests after puberty, presenting as an~     acute abscess in approximately 50% of patients or as a discharging painful sinus. Patients~     may experience lengthy healing times resulting in considerable morbidity and disruption to a~     young adult's life. Eradication of pilonidal sinus is based on a wide surgical excision and~     at the end of the procedure, the wound is dressed with an alginate dressing (Algosteril®).~      The objective is to show a better efficiency of Sorbact TM (trademark) dressings compared to~     Alginates that are standardized dressings after pilonidal sinus excision during a period of~     75 days. The main objective is to show a difference of 20% of wounds completely healed in 75~     days between the two types of dressing: 50% of wounds healed with Algosteril TM compared to~     70% of wounds healed with Sorbact TM.~   "
118858|NCT02011789|"~     Limonoids are compounds found in citrus juices, seeds and peel. Some research shows that they~     reduce blood cholesterol and also reduce the incidence of several forms of cancer. Although~     these compounds are part of the natural human diet, the dose required to provide health~     benefits and the risks associated with the intake of high doses by humans have not been~     studied. This study will examine metabolism, safety, lipid-lowering and anti-inflammatory~     effects of limonoids. The dose of limonoids in this study is equivalent to that found in six~     8 oz glasses of orange juice per day. The investigators hypothesize that limonin glucoside~     supplementation will reduce total cholesterol, LDL cholesterol, ratio of LDL and HDL~     cholesterol, number of LDL particles, and serum markers of inflammation.~   "
118859|NCT02011776|"~     The purpose of this study is to evaluate the effectiveness of fluorometholone combined with~     sodium hyaluronate eye drops in the treatment of Sjögren syndrome.~   "
118860|NCT02011763|"~     The aim of this study is to describe the safety profile of Avaxim 80U Pediatric, in order to~     confirm the good safety profile of the vaccine.~      Primary objective:~        -  To describe the safety of Avaxim 80U Pediatric after each dose of vaccine administered 6~          months apart, in subjects aged 12 months to 15 years.~   "
118861|NCT02011750|"~     This is an exploratory study in Egypt that will combine a treatment trial among early course~     schizophrenia (ECSZ) patients with key analyses suggested by rodent studies. Specifically,~     the study will test the provocative results from animal studies indicating an impact of~     Toxoplasma Gondii (TOX) exposure on novelty seeking. The study will also test whether~     exposure to TOX is associated with other cognitive and behavioral changes, as well as changes~     in overall social function. We will also explore the relative efficacy of Sodium Valproate~     (Depakote, DEP) in improving clinical and overall social function among TOX exposed and~     unexposed patients.~      Hypotheses~        1. At baseline, TOX exposure is associated with increased novelty seeking, clinical~          severity, and impaired cognitive and overall social function in patients with SZ.~        2. Adjunctive DEP treatment improves clinical symptoms, cognitive and social function in~          SZ, particularly among TOX exposed SZ patients.~        3. Exploratory hypothesis: adjunctive DEP reduces serological indices of TOX infection (VIP~          and TH levels).~   "
118862|NCT02011737|"~     The purpose of this study is to evaluate Efficacy and Safety of oral intake of Naftopidil~     75mg once daily for the improving clearance of ureteral or renal stones.~   "
118863|NCT02011724|"~     The objective of the study is to demonstrate that treatment with Apligraf reduces venous leg~     ulcer (VLU)-related pain and improves the quality of life (QOL) of patients with a painful~     VLU.~   "
118864|NCT02011711|"~     Clinical study to determine if hormonal contraceptive use effects cells that fight infection~     (i.e., immune cells).~   "
118865|NCT02011698|"~     this study has the aim to analize the correlation between three different methods of mesh~     fixation ( using absorbable or non absorbable sutures or fibrin biological glue) and~     recurrance and chronic pain ,in the Lichtenstein anterior inguinal erniorrhaphy~   "
118867|NCT02011672|"~     Background: Recent advances in science have established a fundamental role for low grade~     chronic inflammation in mediating all stages of most of the non-communicable diseases~     associated with ageing. Pro-inflammatory effects of hyperglycemia have been described. Dairy~     and its components are known to exert beneficial effects on postprandial hyperglycemia. This~     study investigates if dairy, normal and enriched, can reduce chronic inflammation via~     improvement in glucose regulation.~      Objective: To compare the effect of a nutrient-enriched dairy drink on parameters of glucose~     regulation and postprandial inflammation with the effect of a standard milk drink, within a~     population of overweight, apparently healthy subjects.~      Study design: The study is designed as a double-blind randomized placebo-controlled parallel~     trial during 7 weeks, during which the test and reference products will be consumed at home.~      Main study parameters/endpoints: The difference in absolute change in fasting blood plasma~     concentration of glucose, insulin and IL-6, from baseline to endpoint, and the difference in~     postprandial response of plasma concentration of glucose, insulin and IL-6 at the end of the~     treatment period, between subjects consuming the test and reference product.~   "
118868|NCT02011659|"~     To compare postoperative nausea and vomiting (PONV) and perioperative outcomes of gynecologic~     patients undergoing laparoscopic surgery after scheduled administration of intravenous~     Ramosetron during hospital stays.~        -  Randomized controlled arm : Placebo versus Ramosetron injection~        -  Administration schedule : immediate postoperative status, 12 hrs after surgery, 36hrs~          after surgery~   "
118869|NCT02011646|"~     Few obesity prevention programs have produced weight gain prevention effects that persist~     over long-term follow-up and those that have are extremely lengthy, averaging 52 hr in~     duration, making implementation difficult and costly. The 2010 US Preventative Services Task~     Force (USPSTF) recommendations for treating child & adolescent obesity state that programs~     should have ≥ 25 hr of comprehensive treatment including dietary, physical activity and~     behavioral counseling, and that programs with < 25 hr usually do not produce improvements.~     The implication is that, if centers cannot provide this level of service (as most cannot), it~     is not worth providing any kind of treatment at all. In extreme exception to this, an~     intensive 3-hr non-restrictive obesity prevention program involving participant-driven~     healthy lifestyle improvement plans designed to bring caloric intake and output into balance~     (Healthy Weight) has been found to significantly reduce increases in BMI and obesity onset~     relative to alternative interventions and assessment-only controls through 3-yr follow-up. We~     propose to test an extended 6-hr version of the Healthy Weight intervention in a sample of~     primarily low SES, minority adolescents and young adults who are overweight and report body~     dissatisfaction and subthreshold eating disorder symptoms, as these are prevalent risk~     factors for obesity. We will test the hypothesis that participants assigned to the Healthy~     Weight vs. control intervention will have significantly lower BMI and % body fat during~     follow-up. Secondary outcomes will include body dissatisfaction, depressive symptoms, and~     eating disorder symptoms. 300 adolescents and young adults at high risk for future weight~     gain by virtue of their age, BMI percentile, body dissatisfaction and eating disorder~     symptomatology will be randomized to Healthy Weight or weight control educational video.~     Participants will complete assessments of BMI, body composition, potential mediators, and~     other outcomes at pretest, posttest and 6--mo follow-ups (in yr 1). Thus, to refute the~     USPSTF recommendations statement, we propose to show that a 6-hr intervention led by graduate~     students can produce significant reductions in risk for both obesity and eating disorders,~     suggesting this inexpensive and brief intervention could and should be rolled out nationwide.~      Primary Aim: To test the hypothesis that Healthy Weight will significantly reduce increases~     in BMI, % body fat, and risk for onset of obesity during follow-up.~      Secondary Aim: To test the hypothesis that Healthy Weight will significantly reduce body~     dissatisfaction, depressive symptoms, and eating disorder symptoms.~      NOTE: THIS STUDY IS ONLY OPEN TO PATIENTS AT THE MOUNT SINAI ADOLESCENT HEALTH CENTER~   "
118870|NCT02011633|"~     To compare the pharmacokinetic characteristics between HCP1201 tablet 500/10 mg and~     co-administration of metformin 500 mg plus rosuvastatin 10 mg under fasted and fed state,~     respectively.~   "
118871|NCT02011620|"~     Type 2 diabetes mellitus (DM) is becoming a leading global epidemic. DM affects several~     systems in the body. Most of the complications encountered in DM are attributed to~     uncontrolled hyperglycemia or poor glycemic control. Hyperglycemic stress tends to damage the~     inner lining of the small blood vessels (endothelium). Normally, the endothelium releases a~     chemical substance called nitric oxide (NO) which relaxes the blood vessels and also prevents~     blockade of these vessels. Therefore damage to the endothelium (endothelial dysfunction)~     results in diminished levels of NO which ultimately leads to occlusion of these small blood~     vessels (microvascular occlusion). Microvascular occlusion of vessels supplying the eyes,~     kidneys and nerves leads to serious complications like diabetic retinopathy, nephropathy and~     neuropathy.~      Of late, the skeletal system has emerged as another vulnerable target of diabetic~     microvascular disease. Patients with DM have an increased risk of developing fractures.~     Certain predisposing factors like diabetic neuropathy and visual disturbances (retinopathy~     and cataract) increases the likelihood of fractures in DM. More recently, evolving research~     has demonstrated NO's prospective role in bone preservation. Earlier studies have also~     validated the use of nitrates (donor of NO) in improving bone strength and reducing the risk~     of fractures.~      So far no study has investigated the effect of nitrates on endothelial function and bone~     microarchitecture in patients with diabetes. The investigators therefore propose to~     investigate the influence of nitrates on endothelial dysfunction and bone integrity in~     patients with type 2 diabetes. 40 patients with type 2 DM will be recruited into the study;~     20 patients will receive 20 mg of oral isosorbide mononitrate daily and the other 20 will not~     receive the study drug. The investigators hope to demonstrate an improvement in endothelial~     function (by measuring skin blood flow) and bone integrity (by measuring markers of bone~     formation and bone resorption and bone mineral density - BMD) following 6 months of nitrate~     therapy.~   "
118872|NCT02011607|"~     We propose to collect the data of vital signs and anesthesia medications administered in a~     subcategory of patients coming for anesthesia for upper GI endoscopy. This data will be~     analyzed to see any relation between the preoperative risk factors, procedure, type of~     anesthesia and the airway intervention. The adverse events that will be automatically~     recorded and later analyzed will be number of apnea episodes (described as no respiration for~     at least 30 seconds) duration of each apnea, number and duration of each desaturation event~     (oxygen saturation as measured by the pulse oximeter). A pulse oximeter saturation of less~     than 93 percent and lasting 30 seconds will be considered as a desaturation event. The airway~     interventions that will be recorded will be anything other than considered being routine.~     This includes LMA insertion, endotracheal intubation and the need to withdraw gastroscope to~     facilitate face mask ventilation. We also propose to monitor their awareness/depth of~     sedation/depth of anesthesia levels. This will be done using a monitor that analyses brain~     waves and gives an idea of sleep (anesthesia) depth. We can then see any correlation between~     any unwanted events and the sleep depth.~   "
118873|NCT02011594|"~     There have been reports suggesting that anti-epidermal growth factor antibody nimotuzumab is~     advantageous for advanced esophageal cancer patients in combination with chemotherapy or~     radiotherapy. However, whether maintenance therapy of nimotuzumab provides benefit to~     advanced esophageal cancer patients is not known.~   "
118874|NCT02011581|"~     The purpose of this research study is to learn more about how our body produces sugar, breaks~     down fat for fuel, and makes insulin (the major hormone that controls the production of blood~     sugar and fat breakdown) during a 24-hour day and how body fat and muscle are involved in~     these processes.~   "
118922|NCT02010944|"~     This study compares the pharmacokinetics (PK), safety and tolerability of fixed dose~     combination (FDC) tablets containing solifenacin succinate and mirabegron with the~     co-administration of single entity tablets (SET), at three dose strengths.~   "
118923|NCT02010931|"~     A retrospective analysis of historical data looking at relapse free survival and overall~     survival rates in adult philadelphia negative B-pre-cursor acute lymphoblastic leukemia~     patients.~   "
118875|NCT02011568|"~     This trial is currently a single-center, randomized, double-blind investigator initiated~     prospective clinical trial initiated at the University of Ottawa Heart Institute (UOHI). The~     plan is to expand the trial shortly as a multi-center project. The patients for this study~     will be recruited amongst comatose survivors of out-of-hospital cardiac arrest (OHCA). The~     aim of this study is to determine whether neurologic outcomes at six months are improved with~     moderate (31 degrees Celsius) versus mild (34 degrees Celsius) therapeutic hypothermia (TH)~     following return of spontaneous circulation (ROSC) in patients suffering OHCA, with ROSC~     defined as the resumption of sustained perfusing cardiac activity.~      The primary outcome will be the proportion of patients experiencing death or a poor~     neurologic outcome at six months after out of hospital cardiac arrest.~   "
118876|NCT02011542|"~     The overall objective is to determine whether VSL #3 will improve 1) intestinal symptoms of~     Irritable Bowel Syndrome (IBS) and 2) non-intestinal symptoms (fatigue, joint pain, insomnia,~     general stiffness and headache) associated with IBS. All of these symptoms are part of the~     Gulf War (GW) illness.~   "
118877|NCT02011529|"~     This proposal aims to demonstrate the feasibility and acceptability of adapting TEAMcare for~     patients with schizophrenia. The aim of this innovative mental health center-based team~     intervention is to improve diabetes, cardiovascular and psychiatric outcomes among patients~     with poorly controlled type 2 diabetes. The study will be conducted in two phases over the~     2-year grant period.~      Phase 1. Development of the adapted TEAMcare intervention and training of team members.~      Phase 2. During year 2, we will implement the intervention on the caseload of 40 outpatients~     at Harborview Mental Health Services with schizophrenia and poorly controlled type 2~     diabetes. The intervention involves the management of subjects' diabetes, hypertension, and~     hyperlipidemia by a CMHC diabetes team for 6 months (advanced nurse specialist on-site at~     supervised in weekly meetings by a psychiatrist and a UW Diabetes Center endocrinologist).~      The primary aim of this pilot research grant is to evaluate the feasibility of implementing~     this complex intervention, in order to guide the design of a larger scale efficacy study~     (R01). Both process and outcome measures will be evaluated at baseline, and at 3- and 6-month~     follow-up visits for the 40 subjects enrolled in this feasibility trial.~   "
118878|NCT02011516|"~     Studies show that certain reminders of drug use such as the sight of someone using marijuana,~     pictures of blunts, particular moments throughout the day, prompt marijuana users to smoke~     marijuana. We are measuring the brain and behavioral responses of marijuana dependent~     individuals to these reminders (cues) We will examine brain responses during cue exposure and~     determine whether these responses are associated with treatment outcome.~      We are testing the hypothesis that the medication baclofen reduces brain responses during~     marijuana cue exposure and/or craving in marijuana dependent individuals. Baclofen is~     FDA-approved for other uses, but not for the treatment of marijuana dependence. Functional~     magnetic resonance imaging (fMRI) will be used to measure the brain's response to marijuana~     cues. fMRI is a painless technique that takes special pictures of the brain (or other parts~     of your body). It does not involve radiation or injections.~      Eligible participants will have a 50% chance of receiving placebo (sugar pill) and a 50%~     chance of receiving baclofen. Neither the participant nor study personnel will know whether~     participants are receiving baclofen or placebo. Participants will also receive twice weekly~     psychosocial treatment with a certified clinician. Twelve weeks of treatment will be followed~     by a 12 week follow up.~   "
118879|NCT02011503|"~     The overall objective of this study is to evaluate the effectiveness of dehydrated human~     amnion/ chorion membrane (dHACM) in reducing time to complete wound closure in patients with~     venous leg ulcers (VLUs).~   "
118880|NCT02011490|"~     The purpose of this study is to evaluate the plasma pharmacokinetics of a single 4 mg/kg~     intravenous (IV) dose of sugammadex in participants with moderate and severe renal~     insufficiency compared to that in participants with normal renal function. The study consists~     of two parts. In Part 1, participants with renal insufficiency and healthy participants will~     be administered study drug by IV bolus injection into a peripheral vein. In Part 2,~     participants with renal insufficiency and healthy participants will be administered study~     drug as an IV bolus into a peripheral vein, through an IV catheter connected to IV tubing~     with injection port. Subjects who participate in Part 1 of study may be enrolled in Part 2,~     which would reduce the overall number of participants enrolled for the study.~   "
118881|NCT02011477|"~     The purpose of this study was to evaluate the immediate mechanical hypoalgesic effect of~     neural mobilization in asymptomatic subjects. We also compared neural gliding versus neural~     stretching to see which produced greater hypoalgesic effects in asymptomatic subjects.~   "
118882|NCT02011464|"~     Pain control after knee replacement requires analgesia to both the top (anterior) and bottom~     (posterior) portion of the the knee. Presently we use a nerve block for the anterior portion.~     The investigators want to to examine if giving Exparel into the posterior portion will give~     better pain relief.~      Hypothesis: There is no difference in, the use of analgesics or the length and quality of~     analgesia and no decrease in the time to be able to accomplish simple to complex knee~     movements using Exparel infiltration when compared to controls.~   "
118883|NCT02011451|"~     The hypothesis is that 95% pure EGCG can protect brain cells in patients with Multiple~     Sclerosis. To test this hypothesis we are going to compare the changes in n-Acetyl-Aspartate~     (a chemical that reflects the number of neurons and their metabolism) over one six between~     people with MS treated with EGCG at a dose of 400mg twice a day and people with MS treated~     with a matching sugar pill.~   "
118924|NCT02010918|"~     The purpose of this study is to determine whether 500 mg Glucosamine Sulfate / 400 mg~     Chondroitin Sulfate Capsules and 1500 mg Glucosamine Sulfate / 1200 mg Chondroitin Sulfate~     Sachet is effective and safe compared Cosamin DS ® Capsule in Treatment of Knee~     Osteoarthritis.~   "
118925|NCT02010905|"~     Rationale: The prevalence of adult patients with congenital heart disease (CHD) has steadily~     increased over the last decades, due to the advances in cardiac surgery. A large number of~     these patients cope with right ventricular (RV) volume or pressure overload, largely caused~     by residual lesions after cardiac surgery in childhood. Previous RV overload due to pulmonary~     regurgitation in Tetralogy of Fallot (TOF) can lead to RV dysfunction. These findings warrant~     close surveillance of RV function, and adequate and evidence-based pharmacological therapy to~     reduce both morbidity and mortality in this young patient group. The~     renin-angiotensin-aldosterone system (RAAS) is activated in patients with ventricular~     failure, irrespective of the effected (left or right) ventricle. Angiotensin converting~     enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARB's) are drugs which act as~     inhibitors of RAAS. Previously, large trials have demonstrated the beneficial effect of~     angiotensin converting enzyme (ACE) inhibitors on morbidity and mortality in patients with~     acquired left ventricular (LV) dysfunction. ARB's have a similar effect as ACE inhibitors in~     patients with acquired LV dysfunction but discontinuation because of side effects such as~     cough is less frequent. In TOF patients with RV overload due to pulmonary regurgitation,~     pulmonary valve replacement leads to a decrease in RV size and pulmonary regurgitation.~     Current guidelines advise empiric use of RAAS inhibitors for right ventricular dysfunction in~     adult patients with congenital heart disease. However, the actual effect of RAAS inhibition~     on right ventricular dysfunction in adult TOF patients without severe valvular lesions has~     not been sufficiently investigated. Therefore, we set-up the proposed study, and hypothesize~     that ARB's have a beneficial effect on RV ejection fraction in adult TOF patients with RV~     dysfunction without severe valvular lesions.~      Objective: to improve RV ejection fraction in adult TOF patients with RV dysfunction without~     severe valvular lesions.~      Study design: a prospective, multicenter, double-blind, randomized, placebo-controlled trial.~     Follow up two years Study population: adult patients with Tetralogy of Fallot with right~     ventricular dysfunction, defined as right ventricular ejection fraction < 50% and without~     severe valvular lesions Intervention: patients are randomized to receive either losartan 150~     mg once daily, or placebo in the same regimen. Main study parameters/endpoints: the primary~     endpoint is difference in change in RV ejection fraction, determined by cardiovascular~     magnetic resonance imaging (CMR), between the treatment and the control group at two years~     follow-up.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: All investigations, except blood analysis, are non-invasive and free of risk.~     The burden for the patients mainly consists of the time that is consumed by the visits to the~     clinic. At these visits time will be consumed by: history taking and physical investigation~     (15 minutes); quality of life score (15 minutes); laboratory tests (6 times venopuncture,~     total amount of blood withdrawn approximately 90ml). Cardiopulmonary exercise testing~     (1hour), echocardiography (15 minutes) and CMR (45 minutes) are part of regular medical care.~     Adverse effects from losartan are usually limited and consist of dizziness due to~     hypotension, renal impairment, hyperkalemia and liver impairment. We expect no change or an~     increase in RV function in the intervention group compared to the control group over the~     two-year follow up period, which would be a great benefit for this young study population.~   "
118951|NCT02010567|"~     This trial will enroll patients with locally advanced rectal cancer (resectable and~     non-resectable).The phase Ib dose escalation portion of trial is designed to determine the~     maximum tolerated dose (MTD) of CRLX101 when combined with standard neoadjuvant therapies~     capecitabine (Cape) and radiation therapy (XRT). CRLX101 is a nanopharmaceutical (NP)~     formulation of camptothecin. These results will determine the recommended phase II dose~     (RP2D) for CRLX101 in this setting. The phase II portion of the trial is designed to evaluate~     the efficacy and safety of CRLX101 at the RP2D, when combined with capecitabine and radiation~     therapy prior to surgery.~   "
118884|NCT02011438|"~     Among adolescents, SAD and depression are prevalent, highly comorbid, and can be chronic and~     impairing. Interpersonal peer victimization (IPV) is a key stressor that contributes to both~     social anxiety and depression in adolescents; it includes relational (e.g., social exclusion)~     and reputational (e.g., spreading rumors) forms of peer victimization. Currently, there are~     no preventive interventions for adolescent SAD. Also, effective preventive interventions for~     adolescents have not yet integrated a focus on both social anxiety and depression or targeted~     specific peer risk factors. Interventions for depression and for bullying have not addressed~     IPV, which is less observable than overt victimization (e.g., threats, physical acts).~      Thus, the Peers Emotions and Relationships (PEERS/UTalk) intervention, will take an~     integrated approach to reducing risk for SAD and depression by modifying and adapting an~     evidence-based intervention for depression, Interpersonal Psychotherapy- Adolescents Skills~     Training (IPT-AST), that focuses on improving interpersonal skills and managing conflict. We~     will add a) elements of anxiety-based treatments (e.g., exposures) and b) strategies for~     handling challenging peer experiences. PEERS/UTalk will have a positive focus and will target~     adolescents who report elevated symptoms of social anxiety and/or depression and high levels~     of IPV.~      Following are the aims and hypotheses of the Pilot-Randomized Controlled Trial:~      Aim: Evaluate PEERS/UTalk. We will screen adolescents and conduct a pilot randomized trial of~     PEERS (U Talk) versus an Education/Support (ES) condition with up to 60 high-risk~     adolescents.~      Hypothesis 1: Both PEERS/UTalk and ES conditions will demonstrate: (a) feasibility via rates~     of participation and study completion, (b) intervention credibility via adolescents' ratings~     of acceptability and satisfaction, and (c) high rates of clinician fidelity to the respective~     manuals.~      Hypothesis 2: Adolescents randomized to PEERS/UTalk will show improvements in primary~     outcomes (less IPV, fewer symptoms of social anxiety and depression, improved clinician~     ratings) relative to those in the ES condition.~      Hypothesis 3: The benefits of PEERS/UTalk over ES will be apparent on the secondary outcomes~     of increased quality of close friendships, increased peer support.~      Exploratory Aims: We will examine: (1) the durability and persistence of PEERS/UTalk~     intervention effects versus ES on primary outcomes at 6-month follow-up and (2) potential~     moderators of response to the PEERS/UTalk intervention, recognizing that there are power~     limitations in doing so.~   "
118885|NCT02011425|"~     Previous studies have shown that contractions of the jaw-closing masseter muscle (MAS) often~     occur shortly after respiratory events during sleep in obstructive sleep apnea (OSA)~     patients. Although it has been hypothesized that such non-specific motor activations may~     contribute to restoration of a compromised upper airway during respiratory events, proper~     physiological understanding of MAS contractions in patients with OSA is lacking. MAS~     contractions are usually associated with the termination of respiratory events, but these~     contractions do not always occur after respiratory events. Therefore, the above-stated~     hypothesis that non-specific motor activations of the jaw-closing masseter muscle (MAS) may~     contribute to restoration of a compromised upper airway during respiratory events is not~     accepted yet. Further, Kato et al. concluded from a recent study that MAS contraction is an~     orofacial manifestation of a general motor reaction to arousal occurring during sleep in OSA~     patients. This suggests that MAS contraction after a respiratory event is dependent on the~     arousal response rather than on the respiratory events per se.~   "
118886|NCT02011412|"~     The investigators hypothesize that a risk score composed of age, sex, and the components of~     commonly ordered laboratory panels will be predictive of mortality in trauma patients, and~     will help improve clinicians' ability to make more accurate mortality predictions at the time~     of admission.~   "
118887|NCT02011399|"~     Sensorimotor (also know as mu) rhythm based brain-computer interfaces (BCIs) are a tool for~     controlling electronic devices using only brain signals.~      The Mu rhythm is a naturally occuring wave produced by the brain. This research project will~     determine how to best train subjects to use the Mu rhythm for computer control.~   "
118888|NCT02011386|"~     The study investigates different criteria for remission based on MRI and circulating~     biomarkers for inflammation, cartilage, connective tissue and bone turnover in patients with~     axial spondyloarthritis treated with Golimumab. Furthermore, the study also investigates~     factors that affect disease activity, function and participation by use of different~     questionnaires.~   "
118889|NCT02011373|"~     Laparoscopic sacrocolpopexy is the consensual attitude of choice in genital prolapse but~     incurs problems of tolerance of implanted material. As an alternative to stapling and~     suturing, which cause vaginal erosion, we present a fixation technique using a sterile~     synthetic liquid tissue glue: IFABOND™. A non-randomised prospective multicenter study will~     assess efficacy in terms of 12-month failure of prolapse correction.~   "
118890|NCT02011360|"~     The overall objective is to explore the mechanisms by which macronutrients regulate food~     intake and weight gain in Prader Willi Syndrome (PWS).~      Previous studies from the investigators' labs suggest that the increased appetite of PWS may~     be triggered or maintained by an increase in the levels of ghrelin, an appetite-stimulating~     hormone produced primarily by the stomach. This study will compare the effects of low~     carbohydrate diet versus low fat diet on levels of ghrelin, appetite suppressing hormones and~     markers of insulin sensitivity in patients with PWS.~      The investigators hypothesize that the low carbohydrate diet will suppress plasma active~     ghrelin and increase appetite-suppressing hormones to a greater degree and for longer~     duration than the low fat diet and will thereby reduce hyperphagia and increase satiety. The~     investigators also hypothesize that the low carb diet will improve hormonal and metabolic~     markers (fatty acids, amino acids and organic acids) of insulin sensitivity and inflammatory~     cytokine profiles of children with PWS.~   "
118891|NCT02011347|"~     The objective is to evaluate the sparing effect of ketamine on the dose of propofol.~   "
118892|NCT02011334|"~     This multi-center, open-label, single-arm, Phase IIIb study will evaluate the safety and~     efficacy of subcutaneous RoActemra/Actemra alone or in combination with non-biologic disease~     modifying antirheumatic drugs (DMARDs) in rheumatoid arthritis patients in Latin America with~     an inadequate response to non-biologic DMARDs.~   "
118893|NCT02011321|"~     Vasospasm occurs frequently after aneurysmal subarachnoid hemorrhage and can lead to strokes.~     The investigators will investigate if infusion of a novel drug, clevidipine, will decrease~     vasospasm during the infusion and post infusion period using transcranial doppler monitoring~     of patients with subarachnoid hemorrhage and moderate severity vasospasm~   "
118894|NCT02011308|"~     The purpose of this study is to compare safety and efficacy of Green Light PVP~     (Photoselective Vaporisation of the Prostate) compared to TUR-P.~   "
118895|NCT02011295|"~     The purpose of this study is to determine the clinical efficacy of the application of bone~     marrow aspirate concentrate (BMAC) as a supplement to microfracture in the treatment of~     osteochondral lesions of the talus (OLTs).~   "
118944|NCT02010658|"~     The objective of this prospective randomized trial is to ascertain whether the use of a~     cognitive aid improves adherence to best published practices for the management of simulated~     patients regarding perioperative cardiac evaluation and management.~   "
118945|NCT02010645|"~     The goal of this clinical research study is to learn if eltrombopag given in combination with~     decitabine can help to control advanced MDS. The safety of this study drug combination will~     also be studied.~   "
118896|NCT02011282|"~     We will examine whether the application of electro-neuro-muscular stimulation (ENMS) in~     critical care patients, can decrease the impact or severity of the critical illness myopathy~     (CIM) or neuropathy. We will also assess whether electro-neuro-muscular stimulation affect~     the incidence density rate of nosocomial pneumonia in the ICU.~      Patients will be divided into two groups, Group A and Group B chosen at random. In Group A~     conventional physiotherapy will be applied while in Group B, ENMS will also be applied~     additional to physiotherapy, in the quadriceps muscles. The total time of applying ENMS will~     be 1 hour, it will be applied before the start of the physiotherapy per day of~     hospitalization and for 10 days in each patient.~      The definition of CIM will be based on pathology muscular biopsy (quadriceps). Patients will~     undergo biopsy on the 1st and 11th day after entering the study. The technique of Gomori~     Trichrome will be used to determine the existence or absence of myopathy. In addition the~     ATPase technique will be applied at different prices of PH (PH: 9,4, PH: 4,6 and PH : 4.3),~     thus achieving a separation of myopathy and neuropathy.~      The primary outcome of the study will be the incidence of myopathy in both groups, at day~     12th. Considering that the incidence of myopathy in critically ill patients is 80% reducing~     this rate by 50% in the intervention group using statistical power equal to 0.80 up to a~     level of p <0.05, 12 number of patients will be required in each group.~   "
118897|NCT02011269|"~     This is a randomized, blinded, multicenter study to assess the safety and treatment effect of~     12 weeks of Trichuris suis ova in subjects diagnosed with moderate to severe chronic plaque~     psoriasis.~   "
118898|NCT02011256|"~     The purpose of this study is to determine the frequency of atrial fibrillation in patients~     with transient ischemic attack (TIA). Patients suffering TIA will have their heart rhythm~     extensively monitored with 72-hour Holter-monitoring and an implantable loop-recorder.~     Furthermore, the patients will be examined with echocardiography, coronary calcium-score and~     biomarkers with the purpose to predict which subjects at risk for developing atrial~     fibrillation.~   "
118899|NCT02011243|"~     The main objective of this study is to estimate the incidence and prevalence of Internal~     Rotation Deficit (IRD) defined by a measure of IRD 2 (Internal Rotation Deficit in position~     2) strictly greater than 20 ° in a population of advanced-level handball players over a~     training season.~   "
118900|NCT02011230|"~     Pain after tonsillectomy remains a key barrier during the post operative period. The~     published return rate to the emergency department for hydration and pain control is~     approximately 4%. If we can demonstrate decreased pain or decreased visits to the emergency~     department post tonsillectomy, patient experiences will be improved and health care dollars~     spent will be decreased. We will attempt to improve hydration status by encouraging~     consumption of a novel isotonic hydration solution that is currently commercially available.~      Our study hypothesis is that patients provided an isotonic hydration solution and~     instructions on avoiding dehydration post operatively will have improved pain control and~     decreased emergency department visits.~      Improvement in hydration status has the potential of decreasing emergency room visits and~     subsequent decrease in spending of healthcare dollars. Additional benefits of post-operative~     hydration may include decrease in pain and decrease in post-operative bleeding rates.~      A new isotonic hydration solution with an improved flavor profile (Hoist®) has recently~     become commercially available. Itis very similar to that of Pedialyte, a commonly used~     rehydration solution. Pedialyte was designed for rehydration of infants and small children.~     It has a taste that is not acceptable to many adults and older children.~      This study will implement the use of Hoist as suitable rehydration solution. This study is~     designed to define the relationship between improvement of patient's hydration through~     provision of a rehydration solution during the post operative period and decrease in~     complications requiring return to the emergency room, including dehydration and bleeding, as~     well as improvement in overall pain control.~   "
118901|NCT02011217|"~     The aim of this study is to contribute to a better understanding of how dietary fibre in rye~     affects appetite and metabolic processes. We will evaluate how the intake of rye crisp breads~     affects appetite, insulin secretion and glucose levels in the blood in healthy humans. We~     will also investigate microstructural properties of the crisp breads with microscopy, as well~     as to characterize the food products with respect to the content of dietary fibre and certain~     bioactive compounds. The aim is also to try to elucidate how observed effects on appetite are~     related to changes in insulin and glucose levels, appetite related hormonal signals and~     microstructural properties to verify findings from previous studies.~   "
118902|NCT02011204|"~     This trial is studying Electrical Impedance Myography (EIM) for measuring muscle health. The~     trial is studying people with Amyotrophic Lateral Sclerosis (ALS), other neuromuscular~     diseases, and healthy volunteers to see if the EIM device can measure disease in muscle~     tissue.~   "
118903|NCT02011191|"~     Restless Leg Syndrome (RLS) is a common neuropathic disorder in patients with end stage renal~     disease (ESRD). Study Design: Because micronutrient depletion has been associated with RLS in~     ESRD and because the vitamin biotin is dialyzable, the investigators examined the~     relationship between biotin status and RLS in ESRD. Objectives: To assess the prevalence of~     biotin deficiency in those with and without RLS (Study 1) and to determine the effect of~     biotin supplementation on RLS symptoms (Study 2) in patients receiving chronic dialysis due~     to ESRD.~   "
118946|NCT02010632|"~     The purpose of this study is to compare the pharmacodynamic effect of clopidogrel on the~     platelet inhibition and the pharmacokinetic profiles of clopidogrel carboxylic acid~     metabolite between generic and reference clopidogrel products in Thai healthy volunteers~   "
118947|NCT02010619|"~     To evaluate if Internet delivered cognitive behavior therapy is an efficacious treatment when~     compared to a control group consisting of supportive therapy.~   "
118952|NCT02010554|"~     Between 15-20% of MS patients decide not to initiate disease modifying therapies after being~     diagnosed with MS. For this study, we will develop a telephone-based talk therapy~     intervention and then conduct a randomized controlled trial. Patients will be assigned to~     either 5 weekly 20 minute telephone sessions of psychotherapy or a brief education control~     condition. We hypothesize that patients undergoing phone therapy will be more likely to~     indicate they are interested in initiating disease modifying medications than patients given~     brief education and treatment as usual.~   "
118972|NCT02010294|"~     The main objective of the study is to characterize the virulence factors of SGA and identify~     immunological and / or genetic factors predisposing to infections in children hospitalized~     with invasive GAS infection.~   "
118904|NCT02011178|"~     Background: Diabetic kidney disease (DKD) is chronic and often progresses to kidney~     failure,heart disease and premature death. Unfortunately, the best medical therapies~     available for DKD today are ultimately unable to prevent its progression, especially in obese~     patients.Surgical rerouting of food within the gut with a gastric bypass operation (RYGB),~     improves diabetes and some of its complications.~      The investigators propose to investigate whether RYGB in combination with best medical~     therapy in patients with DKD and obesity prevent further deterioration of kidney function~     over a 3 years follow up period.~      Study design: This is an international collaboration with leading centres in Sweden and~     Switzerland in which100 obese type 2 diabetic patients with established DKD will volunteer to~     be randomly assigned to receive best medical therapy with RYGB or best medical therapy~     without surgery. Participants will be 18-65 years with type 2 diabetes and impaired kidney~     function. Yearly measurements of kidney function will then be done over a period of 3 years~     as a primary outcome to determine whether differences in DKD can be detectable. The study~     will also examine and compare a) safety of the interventions, b) the health economic impact~     on direct healthcare costs and Quality of Life in patients as well as c) the value of a new~     marker of DKD in determining which patients are most likely to benefit from surgery.~      Overall the study will strengthen the evidence base guiding clinical decisions about the~     usefulness of RYGB as an add on therapy to best medical therapy in stopping progressive DKD~     in patients with obesity and diabetes.~   "
118905|NCT02011165|"~     The macular hole formation takes place in the centre of the retina. A closure of the macular~     hole is believed to take place if the central retinal area is kept dry in the postoperative~     period. Therefore the eye is filled with a gas mix and the patients are urged to avoid the~     supine position in the first postoperative days. The investigators use the tennis ball~     technique where a tennis ball is fastened in the back of the night shirt in order to help~     patients compliance in avoiding the supine sleeping position. The investigators have~     developed a positioning measuring device which can measure the extent of supine positioning~     time. Patients are to sleep two nights with the positioning measuring device, one night with~     a tennis ball in the back of the night shirt and one night without. Hereby the investigators~     search new knowledge concerning patients compliance and verification of the tennis ball~     technique.~   "
118906|NCT02011152|"~     The aim of this study was to investigate the effect of i.v. infusion of magnesium sulphate~     during spinal anesthesia on duration of spinal block and postoperative pain.~   "
118907|NCT02011139|"~     Depression is common in end-stage renal disease (ESRD) patients and has a negative effect on~     the quality of life, functional ability, and mortality, with a prevalence rate as high as~     20-25%. However, it is hard to use anti-depressant due to the safety issue, and there has~     been little data so far particularly in terms of randomized clinical trials. Here, we~     investigate the effect of cognitive-behavioral group therapy for enhancing mental health and~     quality of life in patients with ESRD.~   "
118908|NCT02011126|"~     This phase II trial studies the side effects and how well imetelstat sodium works in treating~     younger patients with relapsed or refractory solid tumors. Imetelstat sodium may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
118909|NCT02011113|"~     The purpose of this study is to evaluate the efficacy and safety of pomalidomide in~     combination with dexamethasone in subjects with relapsed and refractory multiple myeloma.~   "
118910|NCT02011100|"~     Carnosine is a naturally occurring compound with a potential health benefits. In animal~     studies, carnosine supplementation reduces manifestation of chronic civilization diseases,~     regulates subclinical inflammation, protein glycation and lipid & glucose metabolism. Our~     preliminary data showed the relationship between insulin resistance and carnosine content in~     human skeletal muscle. Based on these unique results we plan to perform intervention study~     aimed at identifying effects of carnosine on insulin sensitivity and secretion, which might~     reduce the development of T2D in obese. Similar metabolic effects of vitamin D3 were~     associated with expression of specific miRNAs. Circulating miRNAs related to carnosine action~     are unknown. The putative positive effects of carnosine on insulin sensitivity and secretion~     in obese patients might have a tremendous impact in prevention of type 2 diabetes.~     Identification of miRNAs associated with carnosine action could provide predictors of~     successful therapy.~   "
118911|NCT02011087|"~     This clinical trial studies bioelectrical impedance phase angle in predicting treatment~     outcome in patients with extensive stage small cell lung cancer receiving first-line~     chemotherapy. Diagnostic procedures, such as bioelectrical impedance analysis, may help~     predict a patient's response to treatment for small cell lung cancer.~   "
118912|NCT02011074|"~     Preoperative anxiety can be detected via structured and standardised screening by the State -~     Trait Anxiety Inventory (STAI) and Self rating Depression Scale (SDS) questionnaire. The~     investigators evaluate the relation of perioperative anxiety and heart rate variability, also~     the impact of general anesthesia on the change of heart rate variability.~   "
118913|NCT02011061|"~     Coronary calcium hampers accurate evaluation of the coronary arteries with coronary computed~     tomography angiography (CCTA). A novel approach to potentially overcome this limitation is~     coronary calcium subtraction.~      The primary hypothesis of the study is:~      - Coronary calcium subtraction CCTA will improve diagnostic accuracy as compared to~     conventional CCTA on a per-patient basis~   "
118948|NCT02010606|"~     The purpose of this study is to test the safety and effects of a special type of a cancer~     vaccine called a 'dendritic cell vaccine' in patients with either newly diagnosed or~     recurrent glioblastoma. The goal of this dendritic cell vaccine is to activate a patient's~     own immune system against their tumor. This study utilizes a patient's own immune-stimulating~     dendritic cells that are isolated in a procedure called leukapheresis. In a laboratory, these~     dendritic cells are treated in a way that is designed to promote an immune response against~     cancer stem cells. Then the dendritic cells are injected under the skin in a series of~     vaccinations, with the goal of activating an immune response against cancer stem cells in the~     tumor.~      To qualify for this study, patients must have very little to no residual tumor visible on a~     recent MRI. In addition to the vaccines, patients with newly diagnosed glioblastoma will~     receive standard temozolomide chemotherapy and radiation therapy. Patients with recurrent~     glioblastoma will not receive any treatment other than the vaccines as long as they are~     participating in this study, unless they were previously treated with bevacizumab, in which~     case they will be allowed to continue receiving bevacizumab.~   "
118914|NCT02011048|"~     One of five patients undergoing open abdominal surgery develops an abdominal wall defect~     (incisional hernia) as a late complication. A fraction of these are giant hernia with a~     fascial defect beyond 10 cm. These patients are physically severely impaired, and surgical~     treatment is complex.~      Correction of giant incisional hernias including a relatively new and minimally invasive~     technique, (endoscopic components separation) offers promising results. This procedure allows~     the abdominal muscles to be joined centrally restoring the integrity of the abdominal wall.~      The treatment of patients with giant hernia is now centralized at Bispebjerg Hospital~     allowing for a joint study between surgeons, pulmonologists, and sports medicine researchers~     to define the functional and biophysical outcome from hernia repair. We hypothesize that the~     abdominal muscle function is significantly optimized after restoration of the abdominal wall~     using this technique, and that muscular function is crucial for the postoperative quality of~     life. Moreover, we want to assess whether this operation specifically optimizes the function~     and protein synthesis of the abdominal wall muscles, and exerts a beneficial effect on lung~     function. Finally, we will investigate if the patients with giant incisional hernia may be~     identified by an altered composition of their connective tissue as compared with patients who~     do not develop incisional hernia.~      This is a prospective study of two patient groups: 1) Patients with a giant incisional hernia~     and 2) controls undergoing open surgery on other indications. Assessment is done pre- and~     perioperatively and after 1 year including muscular function, lung function, abdominal wall~     anatomy as provided by CT-scan, and quality of life. Specified biopsies from muscles and~     connective tissue are examined for muscle fiber size/type and structure by various methods,~     including electron microscopy and atomic force microscopy. Lung function is monitored by~     blood gas concentrations, Chronic Obstructive Pulmonary Disease Assessment Test~     questionnaire, and regular spirometry analyses. The studies are carried out by Ph.D. student~     Kristian Kiim Jensen, and supervised by professor in surgery Lars Nannestad Jørgensen,~     professor in sports medicine Michael Kjær and professor in pulmonary medicine Vibeke Backer.~   "
118915|NCT02011035|"~     This study is designed to test the safety and efficacy of Colflex, an oral spray created by~     Innotech Nutrition, on human subjects to measure changes on frequency/duration of colds and~     sore throats, as well as dental and oral health changes.~   "
118916|NCT02011022|"~     * The pharmacokinetics of MTX were assessed with regards to the relevance of several~     different patient specific factors in 291 pediatric patients, who were administered with high~     dose of MTX. Population pharmacokinetics of MTX analysis was performed by using nonlinear~     mixed effects modeling.~   "
118917|NCT02011009|"~     Bacterial resistance to antibiotics is a major public health problem. The epidemiology of~     enteric bacteria including E. coli is changing rapidly with the global spread of a resistance~     mechanism type beta-lactamase extended spectrum (ESBL), responsible for resistance to almost~     all penicillins and cephalosporins. The resistance is up to 75% for Quinolones, 67% for~     Cotrimoxazole and 30-50% for Aminoglycosides.~      The main phenomena causing this problem are:~        -  The selection pressure by antibiotics, in their use in humans or animals~        -  The hand transmission via the digestive reservoir (faeces)~        -  Easy spread of resistance mechanism in Enterobacteriaceae due to transferable genetic~          support (plasmid)~      In this context, we decided to implement a cross-border study to improve and accelerate the~     management, diagnosis and treatment of patients with ESBL in close collaboration between~     medical and paramedical staff in hospitals, laboratories and private medical offices.~      The objective of this study is to standardize diagnostic and therapeutic measures allowing a~     better and rapid treatment of patients and thus prevent the appearence of ESBL bacteria in~     the PACA region and Liguria by providing a tool : The Kit ESBL.~      The  ESBL ToolKIT (also translated into Italian) includes:~        -  Information on epidemiological data~        -  A checklist edited for extra-hospital use (private practitioners, health care units~          other than hospitals)~        -  A checklist edited for hospital use~        -  A leaflet BMR for the patient explaining the problematic as well as hygiene measures~        -  Therapeutical protocols for hospital use and extra hospital use~        -  An sample letter for the attending physician~      The objective of this prospective multicenter cohort study is to evaluate the use of this~     kit, and to measure its impact on:~        -  The prescription of appropriate antibiotics~        -  The measures taken to prevent man to man transmission~        -  The quality of information provided to the patient~      In this context we are also performing a multicentre prospective interventional cohort of~     HIV+ patients searching for possible sexual transmission factors in ESBL (extended-spectrum~     ß-lacatamase-producing bacteria) carriers.~      We will also try to determine if other sexually transmitted infections associated (syphilis,~     gonorrhea and chlamydia) are contributing factors to ESBL carriage.~      So far there is no data documented on ESBL-carriage in a population of HIV-positive patients.~   "
118918|NCT02010996|"~     The great saphenous vein is the most commonly used material in coronary vascular bridging~     operation. Coronary bypass operation to obtain the great saphenous vein is mainly through the~     incision open groin to ankle. This operation may damage the lymphatic, cause lymph~     circumfluence obstacle, cause fat liquefaction, scar formation, wound dehiscence, around~     hematoma and other a series of symptoms.Based on some studies and our experience that vacuum~     assisted closure （VAC）is effective in complex wound failures following Stripping saphenous~     vein, we use VAC to prevent seroma formation after Stripping saphenous vein in Coronary~     bypass. This study is aimed to evaluate the efficacy and economics benefits of early VAC~     application on postoperative complications and wound healing after Stripping saphenous vein~     in Coronary bypass in comparison to conventional suction drain.~   "
118919|NCT02010983|"~     Patient with achalasia have a 10-50 fold increased risk to develop esophageal squamous cell~     carcinoma (ESCC). Early diagnosis of ESCC is essential, and detection of an earlier~     dysplastic stage is preferred. Endoscopic detection is however difficult and often delayed.~     Chromoendoscopy with Lugol dye increases detection rates dysplasia and ESCC to 91-100%. The~     aim of this study was therefore to evaluate a screening program using chromoendoscopy with~     Lugol to detect dysplasia in patients with idiopathic achalasia.~      A second objective is to study the relationship between foodstasis and the development op~     dysplasia~   "
118920|NCT02010970|"~     This study is a single-center, open-label, 3-group, fixed-sequence drug-drug interaction~     study to assess the effect of coadministration of multiple-dose itraconazole or diltiazem on~     the single-dose PK of AZD3293 and the effects of coadministration of single- and~     multiple-dose AZD3293 on the single-dose PK of midazolam. The study will also evaluate the~     safety and tolerability of single and multiple oral doses of AZD3293, alone and in~     combination with itraconazole, diltiazem, and midazolam in healthy young subjects.AZD3293 is~     being developed for the treatment of Alzheimer's disease~   "
118921|NCT02010957|"~     Adrenal masses are highly prevalent and detected with high frequency by conventional imaging.~     Conventional imaging often fails to rule out a malignant lesion. Accordingly, most hormonally~     inactive adrenal masses removed by surgery are benign adenomas for which surgical removal is~     unnecessary and poses an avoidable risk to the patients. We hypothesize that the combination~     of FDG-PET and 123I-Iodometomidate imaging has the potential to noninvasively identify benign~     adrenocortical adenomas with high accuracy, thereby avoiding unnecessary surgery. Uptake of~     123I-Iodometomidate by the adrenal mass demonstrates the presence of CYP 11B enzymes which~     specifically bind metomidate with high avidity establishing the adrenocortical origin of the~     lesion, while low uptake of FDG-PET in an adrenocortical lesion establishes its benign nature~     and excludes the presence of adrenocortical cancer (ACC). The proposed trial will assess the~     sensitivity, specificity, positive and negative predictive value of the combined imaging for~     the diagnosis of adrenocortical adenoma. A secondary focus is on the performance of the~     combined test for differentiating ACC from non-ACC lesions. We expect that the results of our~     trial will help to greatly reduce the need for surgery in hormonally inactive adrenal masses.~   "
118949|NCT02010593|"~     This study will evaluate the safety of the dapivirine vaginal ring when inserts once every 4~     weeks in postmenopausal women over 12 weeks of product use.~   "
118926|NCT02010892|"~     This is a prospective observational cohort study that will collect data from the point of~     referral through to secondary care, aiming for 3 years median follow-up (range 1-5 years).~     The data collected will allow estimation of the success of any intervention (in terms of~     reducing rate of aneurysm growth, rupture or dissection) as well as estimation of the risks~     associated with the three procedures. Clinical outcomes in the three treatment groups will be~     described.~      Aims~      We aim to answer the following questions:~        1. Without procedural intervention for chronic thoracic aortic aneurysm (CTAA), what is the~          risk of aneurysm growth, dissection, rupture, permanent neurological injury or death?~          What is the effect on quality of life (QoL)?~        2. If a patient has endovascular stent grafting (ESG) or open surgical repair (OSR), what~          is the risk of growth, dissection, rupture, permanent neurological injury or death?~        3. How does QoL change from pre- to post intervention?~        4. Can aneurysm or patient related predictors of good/poor treatment outcomes be~          determined?~        5. What is the most cost-effective strategy in:~             1. Patients eligible for either ESG or OSR?~             2. Patients eligible for either ESG or best medical therapy (BMT)?~             3. Patients eligible for either watchful waiting (WW) or intervention (ESG/ OSR)?~        6. What further research is required? What would be the most important research to pursue?~   "
118927|NCT02010879|"~     Although thrombocytopenia has been reported as a risk factor for patent ductus arterioses,~     there is lack of data on the function of platelets in ductal closure. Information on~     functions of platelets in ductal closure may change the known model for ductus arterioses and~     may affect the treatment modalities.~   "
118928|NCT02010866|"~     The purpose of this study is to study whether distressed medical residents, fellows, and~     faculty health professionals benefit from completing online an anonymous and interactive~     screening of stress, depression, substance use, and suicidal thoughts. The screening and~     ability to interact online with a clinician anonymously are hypothesized to increase~     willingness to come for counseling in person. Suicide risk factors are expected to be lower~     once the distressed medical trainee or faculty member receives treatment.~   "
118929|NCT02010853|"~     The transient global amnesia, in which the memory disorder is massive, transient and pure,~     offers a unique model for exploring episodic memory. Topographic MRI can reveal a focal and~     selective lesion located on the CA1 region of the hippocampus better visible between 48h and~     72h after onset of the episode.~      There is therefore a real dissociation between structural lesions witch are minimal or~     non-existent and the massive memory disorder. This suggests that functional impairment goes~     far beyond the structural damage in this condition. To our knowledge, no study has been~     performed to identify this functional impairment using resting state fMRI.~      Thus, investigators wish to study the neural networks involved in memory impairment during~     the acute phase of transient global amnesia using resting state imaging. This technique~     appears to be modern and adapted to these patients population. Investigators hypothesize that~     despite limited structural lesions, a large functional network is impaired compared to that~     observed in a group of healthy subjects. investigators believe that the alteration of the~     functional network will explain the depth of memory impairment observed.~      The main aim of this study will be to identify functional impairment in the patient group vs.~     control group during the acute phase of transient global amnesia (TGA) using resting state~     imaging.~      Patients potentially eligible will be informed during their arrival to the emergency unit. If~     the patient is eligible and would like to participate, information will be given. For the~     patients willing to participate, inclusion and exclusion criteria will be verified. Two~     imaging exams (topographic MRI and resting state fMRI) and neuropsychological assessment will~     be performed during three visits.~   "
118930|NCT02010840|"~     Study hypothesis: Childbearing couples who receive the father inclusive psychoeducation~     program will have: (a) a lower level of depressive symptoms, (b) a higher level of marital~     relationship, and (c) a higher level of quality of life at 6 weeks, 6 months and one year~     postpartum than those who receive the usual perinatal care.~   "
118931|NCT02010827|"~     We want to investigate how lack of glucagon suppression during an oral glucose tolerance test~     in patients with type 2 diabetes contributes to patients postprandial hyperglycemia.~   "
118932|NCT02010814|"~     Polycystic ovary syndrome (PCOS) is a common endocrine disorder in premenopausal women. PCOS~     is characterized by increase levels of testosterone, unwanted hair growth, adiposity,~     irregular menstrual cycle, and infertility. PCOS is associated with diabetes mellitus and~     cardiovascular diseases. Women with PCOS are reported to have increased levels of stress~     hormones, which may be associated with decreased quality of life. Increased testosterone~     levels in women may decrease the risk of osteoporosis. The aim of the present study is to~     measure levels of stress hormones in urine and describe quality of life using questionnaires.~     In addition we aim to characterize body composition and bone architecture using DXA and~     ExtremeCT.~      As part of the project, a Biobank with fasting blood samples from participants is~     established.~   "
118950|NCT02010580|"~     Subjects will be randomized in a ratio of 1:1 to receive either 60 mg of ospemifene (Osphena,~     Shionogi, Florham, NJ) or placebo tablet. Placebo tablets will be identical in appearance and~     packaging will be identical for the two pills. The participants will be instructed to take~     one tablet in the morning with food for twelve weeks. Basic demographic information will be~     obtained on all participants. All women will undergo a pelvic examination, and questionnaires~     regarding pelvic floor dysfunction and sexual function before and three months after~     treatment. 3-D ultrasound with Doppler blood flow analysis will be performed before the~     patient is started on the treatment. 3 months after treatment, the 3-D ultrasound with~     Doppler blood flow analysis will be repeated. Four areas will be measured:~        1. The urethra in exactly the same section at the same level with the same setups.~        2. 3 and 9 O'clock position~        3. 6 o'clock position~        4. Clitoral blood flow Doppler blood flow will be visualized using the Doppler color mode~          of the ultrasound machine and will be applied for the assessment of the vascularity~          pattern. Additionally, we will record a film with the use of Color Doppler in a video~          file. The transducer will be immobilized at one selected section and record a ten~          seconds of film. This film will be further analyzed in special software called Pixel~          flux after the examination. Dr. Pawel Wieczorek and Dr. Magdalena Wozniak will read~          these deidentified video files in a randomized fashion based on their previous research~          experience with similar video interpretations of pelvic color Doppler imaging [8-11].~   "
118933|NCT02010801|"~     Liver cancer including primary hepatocellular carcinoma (HCC) and metastatic liver cancers is~     one the most common malignancies in the world. Over 10000 new cases per year are diagnosed in~     Taiwan. Despite the many treatment options, the prognosis of HCC remains dismal. More than~     8000 people died of this cancer every year in Taiwan. A majority (70%to 85%) of patients~     present with advanced or unresectable disease. In contrast, small liver cancers can be cured~     with an appreciable frequency. Five-year disease-free survival exceeding 50% has been~     reported for surgical resection, and for the inoperable patients who do not have vascular~     invasion or extrahepatic spread. Radiofrequency ablation (RFA) is recommended as an~     alternative curative therapy. However, the main drawback of RFA is its limitation to tumor~     size and location. The tumors larger than 5 cm in diameter or located adjacent to vessels,~     could not be ablated completely.~      Irreversible electroporation (IRE), developed and manufactured by AngioDynamics US Ltd, can~     ablate tumor by fenestrating the cancer cell membrane by electric pulse. The anti-tumor~     effect does not result from thermotherapy, so is also not diminished by adjacent vessels.~     Several pre-clinical studies have already demonstrated IRE is a safe and effective treatment~     for live cancers. The system has received CE mark approval in 2008 and FDA approval in 2010.~     However, there is no experience in using IRE fro tumor ablation in Taiwan. In this study, the~     investigators will perform intraoperative IRE for the patients with liver cancers who are~     scheduled to receive hepatectomy in our hospital, and the investigators will evaluate the~     ablate effect of tumors on specimens, and the effect of adjacent vessels. The investigators~     will appraisal the clinical feasibility and advantage of the system by this study.~   "
118934|NCT02010788|"~     This study is a Post-Marketing Surveillance study in Korea to evaluate the safety and~     efficacy of botulinum toxin Type A to treat urinary incontinence in patients with neurogenic~     detrusor overactivity (NDO) or overactive bladder (OAB) not adequately controlled by~     anticholinergic drugs.~   "
118935|NCT02010775|"~     This study will evaluate the safety and efficacy of a range of doses of botulinum toxin Type~     A (BOTOX®) for the treatment of patients with bilateral Masseter Muscle Hypertrophy (MMH).~   "
118936|NCT02010762|"~     The majority of patients with Crohn's disease (CD) need to undergo surgical bowel resection.~     Postoperative recurrence of the disease is virtually inevitable and continues to be one of~     the most challenging therapeutic problems in inflammatory bowel diseases. Medical treatments~     to prevent recurrence have had limited effect. Anti-tumor necrosis factor (TNF) agents appear~     promising but are hampered by immunogenicity, side effects and high cost.~      Vitamin D has recently received a lot of scientific attention and was found to have strong~     anti-inflammatory and antifibrotic effects in gut and liver inflammation. Many CD patients~     appear to have deficiency in Vitamin D. A controlled trial to prevent relapse of CD in~     medical (not surgical) remission suggested a preventive effect for Vitamin D but marginally~     missed its endpoint because of lack of power.~      The ultimate proof of the anti-inflammatory effect of Vitamin D in CD can best be studied in~     the prevention of postoperative recurrence.~   "
118937|NCT02010749|"~     The primary objective of the study was to compare the growth parameters of children~     approximately 2* years of age, who as infants were randomized to receive either a~     lower-protein formula (experimental formula; EF) with 12.8 g/L protein or a standard~     formula (SF) with 14.1 g/L protein or who were human milk (HM) fed for the first 4 months of~     life. The secondary objective was to describe diet and nutrient intake in this cohort of~     children. The exploratory objectives were to describe stool microbiota in a subset of this~     cohort and stool composition (stool soap and nonsoap fatty acids, total fatty acids, and~     minerals) in a second subset of this cohort.~      (* The mean age of subjects was 33.0 months due to a delay in the study start-up.)~   "
118938|NCT02010736|"~     The purpose of this study is to observe the behavior of kinematic variables in children with~     spastic hemiparetic cerebral palsy (SHCP), immediately after treadmill gait training with~     ankle loading.~      The children underwent a single treadmill training session with ankle loading. The kinematic~     parameters were assessed in three phases: before training (PRE); immediately after training~     (POST); and 5 minutes after the end of training (FOLLOW UP).~      The investigators hypothesized that the treadmill gait training with additional lower limb~     loading would be a disturbance capable of modifying the locomotor strategy of children with~     SHCP, by the increase in kinematic parameters in the swing phase of gait.~   "
118939|NCT02010723|"~     The purpose of this study is to compare two therapeutic procedures in the treatment of~     isolated varicosis of the anterior accessory great saphenous vein (AAGSV): crossectomy and~     avulsion of the varicose AAGSV versus foam sclerotherapy of the AAGSV.~   "
118940|NCT02010710|"~     In women judged to require continuous electronic fetal heart rate monitoring (EFM) during~     their labour, does the addition of decision support software to aid the interpretation of the~     intrapartum cardiotocogram (CTG) reduce the number of 'poor neonatal outcomes'? This study is~     not introducing a new form of labour monitoring; it is evaluating the addition of~     decision-support to CTGs displayed on the Guardian™ system. Specifically comparing: No~     decision-support - CTGs with no additional interpretation (UK standard care), compared with:~     Decision-support - CTGs with the decision support software running that will alert~     clinicians to the presence of abnormalities in the CTG in real time. How the labour is~     managed is entirely up to the recruiting unit and the woman; however the allocation of~     decision-support or no decision-support is determined randomly by the Guardian™ system.~   "
118941|NCT02010697|"~     This study examines whether nonsmokers can be mobilized to help smokers quit. We will test,~     via mail campaign, whether targeting nonsmokers can be equally effective in increasing~     smokers' quit rate as targeting smokers directly. The hypothesis is that both targeted~     interventions will lead to a higher quit rate than a control group, which receives one set of~     self-help materials. Each of the targeted intervention groups receives 10 mailings. Smoking~     status of all three groups will be measured at 3 and 7 months post randomization.~   "
118942|NCT02010684|"~     In this project, investigators examine the impact of a mood treatment enhanced diabetes~     self-care intervention for depressed, low-income Latino diabetics. The investigators~     hypothesize that the mood treatment enhancement will lead to significant improvement in both~     diabetes and depression outcomes as compared with the self-care intervention alone.~   "
118943|NCT02010671|"~     We are surveying women who have had a previous cesarean section at the time of entry into~     prenatal care for their next pregnancy about their thoughts related to a trial of labor after~     cesarean (TOLAC) or repeat c-section.~   "
118954|NCT02010528|"~     Parents have an important role in child's diabetes management. Many studies show that~     parental psychological stress and family dynamics are associated with parental~     diabetes-related distress and treatment outcomes among children and adolescents with type 1~     diabetes.~      The aim of this study is to analyze diabetes distress (diabetes-related parenting burden and~     fear of hypoglycemia), parental psychological well-being (anxiety, satisfaction with life,~     positive and negative affect and adult attachment relationship pattern), family hardiness and~     characteristics of children with type 1 diabetes in a sample of mothers and fathers of~     children and adolescents with type 1 diabetes of ages up to 18 years.~      In this study it is hypothesized that:~        1. greater parental fear of hypoglycemia and diabetes-related burden are associated with~          lower family hardiness and worse psychological well-being parents and higher HbA1c~          levels in children and adolescents with type 1 diabetes;~        2. mothers will report greater fear of hypoglycemia, diabetes-related burden and lower~          psychological well-being comparing to fathers.~        3. parents of children and adolescents with type 1diabetes will report greater anxiety,~          lower psychological well-being and family hardiness comparing to parents of children~          without diabetes.~      Standardized and validated questionnaires will be used to determine: parental fear of~     hypoglycemia, diabetes-related burden, parent level of anxiety, psychological well-being,~     adult attachment relationship pattern and family hardiness.~      The investigators will also measure parent daily involvement in child's diabetes management,~     frequency of blood glucose monitoring and parent general satisfaction with glycemic control.~     Objective measures such as child's HbA1c level and experience of severe hypoglycemia episode~     will also be obtained. These measures will be correlated with other research variables.~   "
118955|NCT02010515|"~     This prospective single-center study is an observational risk stratification trial in about~     250 patients with standard indications for ICD treatment.~      Implantable cardioverter defibrillators (ICD) have been shown to improve survival and current~     guidelines recommend their use for primary and secondary prevention of sudden cardiac death~     (SCD). However, a large number of patients never receive an appropriate therapy from their~     device. In contrast, electrical sorm and multiple ICD shocks occur in other patients.~      Thus, identification of predictors for survival or ICD shocks is necessary for improved~     patient selection and optimized therapeutic strategies.~      Risk stratification with electrocardiogram (ECG) and signal averaged ECG (SAECG), T-wave~     alternans (TWA) and Holter ECG including premature ventricular contractions (PVC),~     non-sustained VT (nsVT), heart rate variability (HRV), heart rate turbulence (HRT) and~     deceleration capacity, as well as clinical variables is possible, but not implemented in~     clinical routine in patients with ischemic or dilated cardiomyopathy and newly implanted ICD~     for primary or secondary prevention of SCD following current guidelines.~      Patients will be prospectively followed and the predictive value of the risk markers~     mentioned above to predict all-cause mortality or appropriate ICD shocks will be~     investigated.~   "
118956|NCT02010502|"~     To examine the effects of two forms of beetroot juice supplementation on exercise performance~     in trained cyclists.~   "
118957|NCT02010489|"~     BACKGROUND: Obesity is a global epidemic and Canada has one of the highest obesity rates in~     westernized countries. Obesity has many health related complications, including high blood~     pressure, high cholesterol, diabetes, sleep apnea and osteoarthritis. Bariatric surgery is~     the most effective way of achieving long-term weight loss and treating the complications of~     obesity. There is good evidence to support the relationship between physical activity and~     weight loss following bariatric surgery. While the period leading up to surgery is considered~     an important opportunity for lifestyle modification, evidence to support recommendations for~     a supervised preoperative exercise intervention is lacking.~      OBJECTIVES: The objective of this study is to measure the short and intermediate-term~     benefits of a preoperative exercise intervention on patients awaiting publicly funded~     bariatric surgery in Manitoba. The primary outcome will be improvement in general exercise~     capacity as measured by change in 6-minute walk test (how far a person can walk on a flat~     surface in 6 minutes). Other outcomes will include excess weight loss, change in body~     composition, strength testing and irisin bloodwork & muscle biopsy.~      HYPOTHESIS: It is hypothesized that preoperative exercise will result in improved exercise~     capacity and general fitness in the short and intermediate-term post-bariatric surgery.~      METHODS: Patients who are awaiting publicly funded bariatric surgery in Manitoba will be~     offered the opportunity to participate in a randomized study between usual preoperative care~     (n=35) and usual care plus a supervised exercise program (n=35). Usual care will involve~     multidisciplinary evaluation and preoperative counseling with a kinesiologist. In the~     intervention group, patients will participate in a 12-week supervised exercise program at the~     Reh-fit Centre.~      RESULTS: The study will determine the short and intermediate-term benefits of a preoperative~     exercise intervention on general fitness and exercise capacity as well as weight loss~     post-bariatric surgery. It is an important opportunity for collaboration between a~     multidisciplinary health care team and a medically-certified community fitness centre.~     Currently there are approximately 200 patients undergoing public bariatric surgery annually~     in Manitoba. If this study demonstrates a benefit to preoperative exercise, the results will~     be used to support an application to Manitoba Health for routine implementation of a similar~     intervention for all patients awaiting publicly funded bariatric surgery. It will also be~     used to support an application for a larger multi-institutional study of preoperative~     exercise at several Canadian bariatric centres.~   "
118958|NCT02010476|"~     Type 2 diabetes mellitus has been associated with an about 2-fold increase in risk of~     Alzheimer's disease (AD). Patients with AD have been reported to have reduced insulin~     sensitivity. It may be hypothesized that, compared to insulin sensitive subjects otherwise~     similar in general health and body habitus, insulin resistant subjects are more likely to~     have cerebrospinal fluid (CSF) indicators of incipient AD pathology, abnormalities in CSF~     peptides related to insulin signaling and glucose homeostasis, and possibly other metabolites~     that are associated with a risk of AD. The objective of this study is to examine the relation~     of insulin resistance and the concentrations of CSF biomarkers. The results of this study may~     be useful in the detection of the subjects who are at risk for cognitive decline and AD.~   "
118959|NCT02010463|"~     This study aims to support the hypothesis that brain processes underlying reward processing~     and impulse control contribute to obesity and to adherence in a new exercise regimen.~   "
118960|NCT02010450|"~     This study is a pilot study to test the effectiveness of incentive items to increase~     compliance of infant safe sleep practices among caregivers.~   "
118961|NCT02010437|"~     Leaking valves in the veins of the legs causes veins to become large and bloated. These~     swollen veins are called varicose veins and are a very common problem, affecting more than~     a third of all adults in the UK. Varicose veins reduce people's quality of life by causing~     problems such as pain, itching and restless legs. Varicose veins may also damage the skin~     over time causing problems such as bleeding, skin colour changes, eczema and even break-down~     in the skin which is called an ulcer. Newer, key-hole methods of treating leaky veins have~     been developed as an alternative to surgery and can be performed under local anaesthetic with~     the patient awake. Rather than cuts in the skin, these minimally invasive techniques are~     performed through tiny stab wounds; little larger than needle holes. The varicose vein is~     then destroyed from within, usually using heat to burn the inside of the vein. These~     procedures are popular; with a rapid recovery and a very high success rate. However these~     methods also require the vein to be surrounded by a large volume of dilute local anaesthetic~     which can to be slightly painful to administer. A technique called Foam sclerotherapy~     involves the injection of a drug which has been mixed into a foam. This goes into the vein~     and causes it to stick shut. This procedure is near painless to perform as very few, small~     local anaesthetic injections are required; however the chance for a successful treatment~     first time are lower and patients may need to return for repeat treatments to successfully~     treat the vein.~      The aim of this study is to see whether the success rates for this technique can be improved.~     One method catheter directed foam sclerotherapy involves the delivery of the foam through a~     catheter (a long very thin tube), so that large lengths of vein can be treated through a~     single hole. The final method ClariVein again uses a catheter; but this time the catheter~     has a small wire on the end which spins around inside the vein; similar to an edge strimmer~     in the garden; except it irritates the vein: rather than cutting it. This irritation makes~     the vein more susceptible to the drug which can again be applied directly to the vein wall~     whilst it is still active. Early results show that this final method is very successful;~     however the equipment is more expensive than for the other two.~      This study will randomly allocate willing participants with varicose veins to receive one of~     these three treatments to see whether the two newer treatments can improve the success rates~     and quality of life improvements seen with foam sclerotherapy, whilst also allowing near~     painless treatment, without significant complications, at an appropriate cost.~   "
118973|NCT02010281|"~     This study aims to evaluate the long term efficacy over 25 weeks of repeated sessions of~     magnetic transcranial stimulation of the motor cortex or prefrontal cortex on average pain~     intensity, quality of life, sleep, neuropathic symptoms, return to work, in patients with~     peripheral neuropathic pain.~      The medical device of study: transcranial magnetic stimulator (TMS).~   "
118962|NCT02010424|"~     In cattle less than 10% of the embryos develop to the blastocyst stage when embryos are~     cultured individually, however when bovine embryos are cultured in groups a typical 25-35% of~     blastocysts can be observed. This tendency, i.e. improved embryo development in group~     culture, has also been demonstrated in other mammalian species, such as mouse, cat and human.~     The main reason for this beneficial outcome of group culture has been ascribed to the~     presence of autocrine factors, which are factors secreted by preimplantation embryos that act~     upon the embryo itself or the neighboring embryos .~      Although group culture systems are common in in vitro production systems for animal embryos,~     it is rarely done in human settings, where individual follow-up of the embryo during the~     whole culture period is of utmost importance. Recently a CE-labelled culture device has been~     designed for human embryos, that allow to combine the benefits of both group culture~     approaches and individual culture. The WOW dish is commercially available by Primo Vision and~     consists of 9 small microwells on the bottom of the plate, so that the embryos can be~     cultivated individually in a microwell, but covered by the same drop of culture medium.~      In this clinical randomized trial, 158 patients will be included of which half of the~     fertilized oocytes will be cultured individually (standard culture system) and half of the~     fertilized oocytes will be cultured in group in a WOW dish, both during five days of culture.~     The aim of this study is to increase the number of blastocysts suitable for transfer or~     cryopreservation by culturing the embryos in WOW dishes.~   "
118963|NCT02010411|"~     The hypothesis being tested is that inhibition of the enzyme known as elastase in the airways~     of patients with cystic fibrosis will help decrease the number of bacteria. Alpha1~     antitrypsin, an elastase inhibitor, will be given to patients with cystic fibrosis by aerosol~     therapy twice in 1 day and sputum will be collected to measure the density of bacteria~   "
118964|NCT02010398|"~     The purpose of this study is to determine whether, in patients with multiple sclerosis~     presenting with marked asymmetry of strength, training the less-affected limb with a~     Cross-Training approach may induce a meaningful transfer of strength with neurophysiological,~     functional and clinical correlates, to the contralateral, more-impaired limb.~   "
118965|NCT02010385|"~     Among all the existing ways to treat obesity (lifestyle, pharmacological), Roux-en-Y gastric~     bypass (RYGB) surgery is currently the most effective. It results in long term weight loss~     maintenance, significant remission of obesity-related comorbidities and decreased overall~     mortality. It also induces changes in gastrointestinal hormones responses, with an increase~     of anorexigenic hormones GLP-1, and PYY.~      Although successful, the mechanisms for RYGB-induced weight loss are not completely~     understood. The RYGB does result in increased satiation, decreased calorie intake and~     decreased preferences for sweet and fatty foods. Previous work from our lab has shown using~     progressive ratio task (PRT) that RYGB specifically decreases the appetitive behaviour for~     sweet and fat stimuli but not for vegetables. The reasons for this change in appetitive~     behaviour after the surgery remain unknown. They may be triggered by changes in gut hormones,~     conditioned taste aversion (negative post-ingestive effects) or changes in serum bile acids~     levels.~      This study aims to assess whether RGYB-induced gut hormone changes contribute to the decrease~     in appetitive behaviour for sweet and fatty foods observed after the surgery.~      This is a double blind controlled study comparing the effect of blocking gut hormones with~     somatostatin analogue (octreotide) on the appetitive behaviour for sweet-fat candies will be~     carried out. Appetitive behaviour will be measured using the progressive ratio task.~      The investigators hypothesize that blocking the gut hormones in obese patients with RYGB will~     increase their appetitive behaviour for sweet-fat candies.~   "
118966|NCT02010372|"~     The overall purpose of this study is to evaluate the use of features of the New York State~     Immunization Information System (NYSIIS) by various types of primary care practices and~     determine how best to promote the use of IIS features and functionality. The primary goal is~     to promote the use of NYSIIS for immunization quality improvement (QI) in the practice~     setting. Customized training sessions will be conducted by study staff to educate practices~     on NYSIIS' enhanced features.~   "
118967|NCT02010359|"~     This study is a clinical trial designed to assess whether fish oil treatments are effective~     in the prevention of obesity-related fat tissue (adipose) inflammation. Specifically it~     addresses the hypothesis that fish oils treatments will reduce signaling by chemokine~     pathways (fractalkine and MCP-1) important in adipose tissue for the recruitment and~     activation of certain white blood cells (macrophages). The study is a double-blind~     placebo-controlled trial of the fish oil Lovaza from GlaxoSmithKline (omega-3-acid ethyl~     esters; a combination of ethyl esters of eicosapentaenoic acid (EPA) and docosahexaenoic acid~     (DHA)) in obese non-diabetic adults, to determine if Lovaza decreases markers of inflammation~     and macrophage activation in adipose and blood and understand the mechanism by which fish~     oils affect inflammation.~   "
118968|NCT02010346|"~     The aim of this longitudinal randomized investigation is to determine the long-term effects~     of early headgear treatment on craniofacial structures and dental arches, compared to~     treatment started later, during the most active growth period in Class II patients.~      The aim was further to find out the possible benefits and the burden of early treatment to~     the patients and parents of these common malocclusions, when compared to groups treated~     later, but with the same methods as much as possible.~      The hypothesis is that the timing of treatment has significant effects on orthodontic~     treatment total time, the general outcome of the treatment, and the compliance of the~     patient.~   "
118969|NCT02010333|"~     The primary purpose of the study is to evaluate safety and tolerability of a single~     application of Ha44 Gel 0.74% w/w for the treatment of head lice. Secondary purpose is to~     evaluate PK of Ha44 and benzyl alcohol under conditions of maximal exposure in pediatric~     population.~   "
118970|NCT02010320|"~     Dosing of tacrolimus is challenging due to the large inter-individual variation in its~     pharmacokinetics. The investigators have developed a pharmacokinetics population model that~     can be used to estimate individual doses of tacrolimus in renal transplant recipients. The~     model will be prospective tested in a randomized clinical trial.~      The hypothesis is that the computer model is superior to experienced transplant physicians in~     reaching and keeping the patients in the target range of tacrolimus.~   "
118974|NCT02010268|"~     This study aims to evaluate a clinico-biological predictive score, associating the faecal~     calprotectin, for the diagnosis of enterocolitis and enteropathy of the preterm neonates.~   "
118975|NCT02010255|"~     This study will evaluate ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus~     ribavirin (RBV) in participants with advanced liver disease or posttransplant and chronic~     genotype 1 or 4 hepatitis C virus (HCV) infection.~        -  Cohort A: decompensated cirrhosis (advanced liver disease), no prior liver transplant;~        -  Cohort B: post-liver transplant, with or without cirrhosis;~        -  Group assignment within cohorts is based on severity of liver impairment at screening~          (Child-Pugh-Turcotte (CPT) score for participants with cirrhosis; fibrosis; or presence~          of disease for fibrosing cholestatic hepatitis (FCH) groups)~        -  Randomization is 1:1 within groups to 12 or 24 weeks of LDV/SOF+RBV treatment.~   "
118976|NCT02010242|"~     NADPH oxidase enzymes (NOX) have been implicated in the development of several diabetic~     complications including diabetic nephropathy. GKT137831 is the first in class NOX1/4~     inhibitor.~      The primary objective of this study is to evaluate the efficacy of oral GKT137831 in patients~     with residual albuminuria despite maximal inhibition of the renin angiotensin aldosterone~     system.~   "
118977|NCT02010229|"~     The purpose of this study is to identify what factors -either individual or related to the~     type of management received- influence the maternal outcomes in pregnant women at high risk~     for placenta accreta i.e , women with placenta praevia and previous caesarean.~      This population-based study conducted in 8 French regions will also provide valid estimation~     of the incidence of placenta accreta among all parturients and among at risk women.~     Finally, a psychological evaluation of these women up to 1 year after delivery will provide~     information on the impact of these conditions on women, beyond somatic complications.~   "
118978|NCT02010216|"~     This open-label, single arm study evaluated the efficacy and safety of RoActemra/Actemra~     (tocilizumab) in patients with rheumatoid arthritis. Patients received RoActemra/Actemra 8~     mg/kg intravenously every 4 weeks, alone or in combination with standard anti-rheumatic~     therapy, for 12 weeks.~   "
118979|NCT02010203|"~     This study is a two part study: Phase I and Phase II. The Phase 1 portion is an open-label,~     safety study. Patients will have previously received 3-6 instillations of weekly intravesical~     Bacillus Calmette-Guerin (BCG) induction therapy (as standard of care) followed by low dose~     intradermal (1*10^6 cells) HS-410 monotherapy. In Phase 2, patients will be assigned to~     treatment groups based on whether they will receive induction BCG in the typical post-TURBT~     window. If the investigator plans to administer BCG, patients will be randomized to one of~     three blinded (physician-patient), placebo-controlled groups and receive either intradermal~     placebo or low dose (1*10^6 cells) or high dose (1*10^7 cells) vesigenurtacel-L in~     combination with induction and maintenance intravesical BCG. If patients will not receive~     BCG, they will be enrolled into an open-label, non-randomized group and receive high dose~     (1*10^7 cells) intradermal HS-410 monotherapy.~   "
118980|NCT02010190|"~     This is an observational study that will collect data from adult survivors of childhood~     cancer and compare it to data collected from age- and gender-matched controls for the purpose~     of assessing vascular risk among cancer survivors.~      Advances in cancer therapies have led to increasing numbers of adults previously treated for~     a pediatric malignancy, many of whom experience late adverse health-related sequelae and are~     at risk for developing chronic conditions related to their prior therapy. The epidemiology of~     many end-organ toxicities has been described, yet the pathophysiologic mechanisms of injury~     are incompletely understood. One mechanism may be damage to the circulatory system, in~     particular the endothelial layer, initiating an inflammatory state leading to dysfunction and~     premature atherosclerotic disease. This process may begin and significantly progress in a~     sub-clinical nature for many years prior to manifesting as a cardio- or cerebrovascular~     event. Using established and novel biomarkers predictive of atherosclerotic disease combined~     with unique measurements of vascular function, this study will assess pre-clinical vascular~     disease in a population of childhood and adolescent cancer survivors. The goals of this~     project are to investigate the effects of cancer therapy on the vascular system and acquire~     new knowledge with which to risk-stratify survivors and plan interventional studies to~     prevent or reduce premature vascular morbidity and mortality.~   "
118981|NCT02010177|"~     To assess the ability of baseline clinical parameters and imaging modalities to predict short~     and long term left ventricular function and clinical outcome of subjects with low-gradient,~     severe aortic stenosis.~      To assess the impact of aortic valve replacement as compared to medical therapy on clinical~     outcome of patients with low-gradient, severe aortic stenosis.~      To assess possible impact of aortic annulus assessment using 3-dimensional imaging modalities~     on the assessment of AS severity and definition of low gradient severe aortic stenosis.~   "
118982|NCT02010164|"~     Delaying first childbirth is a progressive trend in the developed societies. Several theories~     tried to explain the reproductive aging, in purpose to hasten it. One of the theories include~     mitochondrial dysfunction with aging. In this study we will investigate the potential of~     treating elderly IVF patients with CoQ10, a mitochondrial stimulator, to improve follicle~     cells' properties.~   "
118983|NCT02010151|"~     The hypothesis of this study is Dispatcher-Activated Neighborhood Access Defibrillation and~     Cardiopulmonary Resuscitation (NAD-CPR) would improve survival of out-of-hospital cardiac~     arrest (OHCA).~   "
118984|NCT02010138|"~     Eligible patients who were scheduled for surgery for idiopathic macular hole (MH) were~     equally randomized to small extent group or large extent group depending on the extent of~     internal limiting membrane (ILM) to be removed. The ILM was peeled in round shape with the~     radius of either 0.75-disc diameter or 1.5-disc diameter according to the group. The primary~     analysis was conducted to identify the difference of functional and anatomical outcomes~     between the two groups. Subsequent analysis was performed to reveal the relationship between~     the functional and anatomical outcomes.~   "
119001|NCT02009917|"~     Protein is a major structural component of all cells in the body. The nutritional importance~     of protein is because of their amino acids. 9 are called essential and 11 are called~     non-essential, based on whether we need to get them from diet. This classification is based~     on studies done using older techniques. Recent studies suggest that these so called~     non-essential amino acids play important roles in our body's health. For the first time, this~     proposal defines an experimental design to examine non- essential amino acid/nitrogen~     requirements and metabolism in humans using the Indicator Amino Acid Oxidation (IAAO)~     technique.~      The objective of the current study is to examine the application of IAAO technique to~     determine the non-essential amino acid/nitrogen requirement in adult humans.~   "
118985|NCT02010125|"~     This study will evaluate the bio-mechanical and biochemical abnormalities in acute~     ACL-injured knees over time. Data will be collected through advanced quantitative MR imaging,~     functional testing, and bio-specimen collection. Researchers will collect this data from the~     time of baseline visit, which is within 28 days of injury, through the temporal sequence of~     post-operative or post-injury recovery and return to activity.~      The hypotheses for this study are (1) that T1ρ and T2 will be significantly elevated in the~     lateral side of ACL-injured knees immediately after injury (indicating damage caused by~     initial injury), and will not fully recover at 6-month, 1-year follow ups; (2) that T1ρ and~     T2 will be significantly elevated in the medial side of ACL-injured knees at 1-year~     follow-up; and (3) that differences in the bio-marker expression patterns can be correlated~     with the initial MRI findings, which would provide information regarding the full spectrum of~     intra-articular pathology and the subsequent clinical outcomes.~   "
118986|NCT02010112|"~     A new method of breath collection for testing for Helicobacter Pylori infection has been~     developed by Exalenz. In this study, it will be compared to the gold standard- endoscopy~     results to prove its accuracy.~   "
118987|NCT02010099|"~     Eligible patients with bleeding hemorrhoids of grade 2-3 are randomized to test-1 product~     (PP110 Gel), test-2 product (PP-110 medicated wipes) or control (Preparation-H cream).~      Test product usage: once daily, about 1-5 minutes prior to first bowel movement. Control~     product usage: according to label, 3-4 times daily application to rectal region.~      At the end of each day, subject fills a questionnaire regarding bleeding, pain, discharge,~     swelling, itching, discomfort and painkiller usage.~      Treatment is for two weeks, after which subjects fill a feedback questionnaire addressing~     treatment efficacy and subject satisfaction. Also, at the end of two weeks, subjects are~     examined by study physician who assesses hemorrhoid severity.~   "
118988|NCT02010086|"~     The study is a randomized controlled trial to examine the efficacy of individual cognitive~     behavioral therapy (CBT) relative to a standard community treatment, in youngsters with~     autism spectrum disorder (ASD). The individual CBT program has been tailored over the last~     five years to the clinical needs of high-functioning youth with ASD.~   "
118989|NCT02010073|"~     We wish to prospectively assess the burden of, management and therapeutic approaches to, and~     outcomes from acute hypoxaemic respiratory failure requiring ventilatory support, during the~     winter months in both the northern and southern hemispheres. We wish to specifically examine~     the contribution of ARDS as defined by the Berlin Definition to the burden of hypoxaemic~     respiratory failure.~      Why?~      The purpose of this study is to provide new and current data on the disease burden of acute~     hypoxemic respiratory failure and ARDS. It will answer the following questions:~        -  What is the frequency and disease burden of acute hypoxaemic respiratory failure in~          winter?~        -  What are the aetiologies of acute hypoxaemic respiratory failure requiring ventilatory~          support?~        -  What is the incidence of ARDS based on the Berlin definition within this patient cohort?~        -  What is the mortality from ARDS within this cohort, and how does this vary based on ARDS~          severity?~        -  What is the natural history of ARDS?~        -  What are the key patterns of therapeutic resource utilization, particularly approaches~          to sustain gas exchange, in these patients?~      When?~      The study is performed over a 4 week period between February 1st and March 31st 2014 in the~     Northern Hemisphere and June 1st to August 31st in the Southern Hemisphere.~      What data is required?~      A basic dataset is collected on all patients admitted with acute acute hypoxaemic respiratory~     failure requiring ventilatory support, with a more detailed dataset collected on patients~     diagnosed with ARDS.~   "
118990|NCT02010060|"~     This study will determine the health benefits of combining exercise training and increasing~     the amount of physical activity in daily life on the fat around the abdomen, weight, fitness~     and sensitivity to insulin. Volunteers will participate in one of three groups for 6 months:~     1) a control group, 2) exercise training only, or 3) exercise training and increasing~     physical activity outside of training. The exercise training will follow the public health~     recommendations for exercise (150 minutes/week of moderate exercise). The group increasing~     physical activity along with exercise training will be asked to increase physical activity in~     their daily life (up to 3,000 step/day above their current levels through the use of step~     counters), and meetings focused on behavior modification. The investigators hypothesize that~     combining aerobic training and additional physical activity after training will have the most~     profound reduction on waist circumference and body composition.~   "
118991|NCT02010047|"~     The anaplastic lymphoma kinase gene(ALK) is mutated approximately 5% of non-small cell lung~     cancers. Testing for this gene is important because there are drugs known as ALK inhibitors~     that have been shown to significantly delay the progression of ALK-mutated lung cancers.~     There are a number of ways to test for the presence of the ALK gene in lung cancer biopsy~     tissue. One method involves making slides and staining them to detect the ALK protein. This~     is called immunohistochemistry. Another method called fluorescence in situ~     hybridization(FISH)is used to detect rearrangements of the ALK gene associated with lung~     cancer. Although both these tests are widely used to test for ALK gene abnormalities, the~     techniques may not always find the ALK gene mutation because they are not sensitive enough or~     not enough cancer cells are present in the lung biopsy.~      This study is being performed to determine if a technique called quantitation polymerase~     chain reaction (qPCR) is as accurate or better at finding the ALK gene mutation in lung~     cancer biopsy tissue.~   "
118992|NCT02010034|"~     This study is being done to determine if an investigational study drug called Omegaven can~     help to improve liver disease thought to be caused by Total Parenteral Nutrition (TPN). TPN~     is intravenous feeding (IV feeding tube) that provides patients the nutrients when they are~     unable to drink fluid or eat food by mouth.~   "
119013|NCT02009761|"~     BI 655064 will be administered subcutaneously once weekly in patients with immune~     thrombocytopenic purpura (ITP) for up to 12 weeks.~   "
119014|NCT02009748|"~     Previous studies suggested that vitamin D deficiency is highly prevalent in cirrhotic~     patients and is related to the degree of liver dysfunction as well as mortality. In~     gastrointestinal disorders, vitamin D absorption can be highly reduced.~      We herein aim to investigate the efficacy of oral vitamin D supplementation in cirrhotic~     patients with vitamin D insufficiency.~   "
139605|NCT01740024|"~     The primary objective of this clinical trial is to quantify the loss of in vivo biological~     potency of a depigmented polymerized (DPP) allergenic cat epithelial extract versus the~     native allergenic extract (N).~   "
118993|NCT02010021|"~     Some tumors use estrogen in the body to assist with growth. Letrozole is a drug that is~     prevents cells from producing estrogens. This should assist with the slowing of growth of~     tumor cells. Letrozole also promotes cell destruction by inhibiting a cellular destruction~     pathway.~      The objectives of this study will look at the differences between the cellular destruction~     pathway before and after letrozole use, and the differences in the cellular destruction~     pathway in participants that have received letrozole versus those who did not. The study will~     also look at a gene in all participants called Ki67. This gene is associated with the rate of~     tumor cell growth. The study will measure the levels of Ki67 and compare them to the amount~     of activation of the cellular destruction pathway.~      Participants in this study will have undergone a diagnostic biopsy of their breast tissue.~      In order to meet these objectives, one group of participants (Arm A) will not receive~     letrozole. Tissue leftover from their diagnostic biopsy will be treated with RAD001~     (Everolimus) in the laboratory and the effects of this drug on the cellular destruction~     pathway will be studied.~      The other group of participants (Arm B) will take letrozole for a minimum of 10 and maximum~     of 21 days. They will have a second tumor sample taken as part of their surgical procedure~     completed to remove the tumor tissue. Any differences in the cellular destruction pathway~     before and after exposure to letrozole will be measured.~   "
118994|NCT02010008|"~     ¡Fortaleza Latina! is a multi-level randomized trial to increase participation in mammography~     screening among Latinas who seek care at a community health center in Western Washington.~      In partnership with the partnering community health center, we have obtained lists of women~     patients aged 42 to 74 years old who had not had a mammogram in the last two years and~     resided within defined radii of the four clinics. Baseline and one year follow-up surveys~     will be obtained by in person home interview. Participants are randomized within clinic to~     intervention or comparison group. The intervention consist of two motivational interviewing~     sessions, one in person in the home, and one telephone follow-up. The study hypothesis is~     that a higher proportion of participants in the motivational interviewing arm will obtain a~     screening mammogram within the study period than those in the comparison arm.~   "
118995|NCT02009995|"~     BACKGROUND Resistance exercise training with free weights or weight machines clearly improves~     glucose (sugar) control in type 2 diabetes (T2D). However, many patients with T2D would~     prefer not to attend an exercise facility, for reasons of cost and/or convenience.~     Coinvestigator Jonathon Fowles has developed and pilot-tested a home-based exercise program~     for people with T2D using resistance bands. However, the effects of resistance-bands training~     (on glucose control in T2D have not been evaluated in a high-quality randomized trial.~      SPECIFIC AIMS To determine the effects of six months of progressive home-based resistance~     bands training (RBT) versus no RBT in people with T2D on blood glucose control (HbA1c,~     primary outcome), waist circumference, heart disease risk factors, and quality of life.~      METHODS A total of 100 T2D participants will be randomized to 2 arms: home-based RBT (RBT-H)~     or aerobic training only (ATO). Both groups will accumulate 150 minutes per week of aerobic~     exercise such as walking. The resistance exercise workout includes 12 exercises, targeting~     all major muscle groups. RBT-H subjects will complete most exercise at home with periodic~     supervision.~      SIGNIFICANCE The global burden of type 2 diabetes is increasing, and complications of the~     illness occur primarily in those whose glucose control is fair or poor. If exercise training~     with resistance bands improves glucose control, it could be beneficial to the large numbers~     of patients who cannot travel to a gym or cannot afford gym membership. If resistance~     exercise is then adopted by more patients, it is likely that the morbidity associated with~     type 2 diabetes will be decreased. This is particularly true if such training also improves~     quality of life, and more people are thus inclined to continue exercising in the long term.~   "
118996|NCT02009982|"~     The purpose of this study is to evaluate the effectiveness of cardioneuroablation for the~     treatment of neurocardiogenic syncope (NCS), also known as vaso-vagal syncope. Syncope is a~     general term for passing out spells and neurocardiogenic syncope is a specific form of~     passing out spells caused by sudden drops in heart rate or blood pressure. Although the~     specific mechanisms of NCS are not well understood, it is believed that some people are prone~     to developing passing out spells in specific situations such as standing up for a long period~     of time, pain or nausea. In these situations, the body reacts with a paradoxical reflex which~     leads to a drop in blood pressure and heart rate and causes passing out. Certain types of~     medications are used to treat NCS including beta-blockers, midodrine and florinef, among~     others. However, none of these medications are particularly effective at preventing passing~     out spells and many people continue to have episodes despite trying different medications.~      Cardioneuroablation is a new form of treatment for NCS. The term ablation means using a wire~     to make small electrical burns in the heart. Ablation has been used for many years to treat~     other electrical disturbances in the heart but the use of ablation to treat NCS is a new~     application. The goal of cardioneuroablation is to identify areas within the heart which are~     believed to initiate the reflex which triggers the drop in heart rate and blood pressure that~     leads to passing out. In preliminary studies, it has been suggested that cardioneuroablation~     may be significantly more effective than medications at preventing passing out spells for~     people with NCS.~      Hypothesis: Cardioneuroablation of vagal inputs in the left atrium may serve as an effective~     treatment modality for the prevention of NCS by blunting the initial trigger of the cascade~     that leads to symptoms and syncope.~   "
118997|NCT02009969|"~     The purpose of this study is to compare abdominal weight gain and fat distribution to changes~     in brain morphology in people taking antipsychotic medications.~   "
118998|NCT02009956|"~     To evaluate long-term safety and performance of the DESyne Novolimus Eluting Coronary Stent~     System and the DESyne BD Novolimus Eluting Coronary Stent System~   "
118999|NCT02009943|"~     Critically ill surgical patients are observed to have a functional iron deficiency which~     contributes to anemia, iron-deficient erythropoiesis, and an increased red blood cell~     transfusion requirement. Previously, iron supplementation has been studied in this population~     with the administration of enteral ferrous sulfate and intravenous iron sucrose but without~     robust results in resolving serum and bone marrow iron debts.~      Ferric carboxymaltose (FCM) is novel iron-containing complex that allows for the~     administration of a large dose of iron over a short infusion period to allow for sustained~     delivery of iron to target tissues with minimal hypersensitivity reactions. While there has~     been reported increased efficacy and comparable safety of FCM when compared to iron sucrose~     in the outpatient setting, there is no data comparing these two medications in surgical~     critical illness.~      The aim of this pilot trial is to compare two novel dosing schemes of these medications for~     treatment of functional iron deficiency in surgical ICU patients. The investigators~     hypothesize that iron supplementation with FCM, as compared to both iron sucrose and placebo,~     is more effective and equally safe for replacing the serum iron debt.~   "
119000|NCT02009930|"~     Hypothesis: Enlisted military members with 10 or more years of service and at least one~     cardiovascular risk factor will demonstrate a higher risk of future cardiac events as~     assessed by coronary artery calcium scoring than the risk calculated by the Framingham Risk~     Score.~   "
119002|NCT02009904|"~     Phenylketonuria(PKU)is a rare condition caused by the body's inability to properly breakdown~     an amino acid called phenylalanine(PHE), due to a missing enzyme, phenylalanine~     hydroxylase(PAH). When the enzyme is missing and/or not functioning properly, it increases~     the level of PHE in the body. High levels of PHE can cause severe brain damage or nerve~     damage unless the children are on a strict low PHE diet. A low PHE diet restricts the intake~     of protein rich foods and can pose a significant burden to both the patient and the family.~      Investigators at the University of British Columbia and British Columbia Children's Hospital~     will examine the phenylalanine metabolism in children with PKU using a simple breath test.~      Patients (5-18y) receiving standard clinical care at the BC Children's Hospital's Biochemical~     Diseases Clinic will be enrolled.The study will be conducted twice on each patient. Baseline~     measurements will be performed at the beginning of each study for each patient.The Physician~     in charge will then prescribe the standard dose of sapropterin dihydrochloride (Kuvan®)~     (20mg/kg/d) or otherwise as deemed appropriate by the physician-in-charge. The test will be~     repeated a week (minimum) after the beginning of treatment with the prescribed dose.~      The investigators propose that children who are responsive to sapropterin dihydrochloride~     (Kuvan®) will have increased 13CO2 in breath after treatment, and those who do not respond~     will have no change in the 13CO2 in the breath before and after treatment.~      As a comparison to the experimental group, age and gender matched healthy controls will also~     be studied. The test in healthy controls will be performed once without any intervention, and~     is only used as a comparative value.~   "
119003|NCT02009891|"~     To determine in women undergoing IVF who are at high risk of multiple births (>35%), as~     calculated by the application of a predictive model - IVFsingleTM, if single embryo transfer~     will lead to both comparable clinical pregnancy rate (CPR) and other secondary outcomes such~     as live birth rate (LBR) and cumulative live birth rate (cLBR) in comparison to DET while~     reducing the incidence of multiple births (a secondary outcome measure).~   "
119004|NCT02009878|"~     This is a study to evaluate how the body handles and metabolizes (PK) the various doses of~     the drug Tolvaptan, and what the effect (PD) of the various doses of Tolvaptan are on the~     content of salt in blood and urine~   "
119005|NCT02009865|"~     This is a double-blind, randomized, olive oil-controlled study to investigate the efficacy~     and safety of Epanova as an adjunct therapy to diet for reduction of TG levels in subjects~     with severe hypertriglyceridemia. The study consists of an approximately 8-week screening~     period that includes a diet and lifestyle stabilization and washout period and a 12-week~     treatment period.~   "
119006|NCT02009852|"~     The Role of microRNA-29b in the Oral Squamous Cell Carcinoma~   "
119007|NCT02009839|"~     The main aim of this study is to examine the effectiveness of a web-based CBT protocol~     (entitled Meeky Mouse) in the treatment of children with Selective Mutism in Singapore. The~     researchers hypothesized that the Meeky Mouse program would be associated with higher~     frequency of speaking behaviors, lower levels of anxiety, greater improvements in~     clinician-rated severity of mental illness, and higher clinician-rated improvement scores at~     post-treatment.~   "
119008|NCT02009826|"~     Previous research has suggested central nervous system inflammatory activity to be critically~     involved in disease development and progression in schizophrenia, with a complex interplay of~     inflammatory mechanisms leading to the development of brain abnormalities and medical~     symptoms related to schizophrenia. However, the mutual interactions of different inflammatory~     pathways and their relation to disease course have not been sufficiently studied. This study~     therefore aims to explore the interaction of neuroinflammatory mechanisms in patients with~     schizophrenia and to assess whether the inflammatory activity in schizophrenia is~     state-dependent and occurs mainly during psychotic episodes.~   "
119009|NCT02009813|"~     Obesity is an epidemic in Western society and is the biggest risk factor for insulin~     resistance and type 2 diabetes. The investigators have recently shown that exposure to~     hyperbaric oxygen (HBO) leads to an increase insulin sensitivity in males ubjects and that~     this improvement can be measured in all men, not just those with diabetes. The aim of this~     study is to investigate the time course of this effect and explore the mechanisms involved.~     The investigators suspect that insulin sensitivity as measured by~     hyperinsulinaemic-euglycaemic clamp will be increased within the time-frame of one 2-hour~     hyperbaric oxygen exposure, and that the improvement will be measurable in females as well as~     males.~   "
119010|NCT02009800|"~     This randomised clinical trial aims to determine whether an immunization schedule comprising~     two doses of Gardasil administered six months apart is non-inferior to a schedule comprising~     three doses administered at 0, 6 and 60 months for the prevention of HPV-16 and HPV-18~     infections that persist for at least six months, up to ten years after the initial~     vaccination.~      The study hypothesis is that the two-dose schedule would offer similar protection as that of~     a three-dose schedule against persistent HPV-16/18 infections.~   "
119011|NCT02009787|"~     The investigators planned to research the effect of vitamin D supplementation as an adjuvant~     therapy for patients with hypercholesterolemia.~   "
119012|NCT02009774|"~     Adenomas and hyperplastic polyps are polypoid lesion and may occur at any location in the~     colon. At the present moment, all polyps should be resected endoscopically, although only~     adenomas, but not hyperplastic polyps have the potential to develop colorectal cancer. This~     approach enables the conduction of microscopic investigations of the lesions. By today, only~     the pathological diagnosis can distinguish exactly between adenomas and hyperplastic polyps.~     Some studies have investigated the value of the socalled optical biopsy method. Optical~     biopsy means the visual assessment of the polyp and the determination of a diagnosis solely~     on behalf of optical criteria. This method is conducted in real time during colonoscopy. If~     it can be shown, that endoscopist using optical biopsy are able to predict histopathological~     diagnoses of colonic polyps sufficiently this would possibly lead to simplification of~     diagnostic procedures. For instance, it would be conceivable to resect hyperplastic polyps~     and small adenomas and discard them without further assessment by a pathologist.~     Gastroenterological societies demand for a 90 percent accordance between diagnoses set by~     endoscopists and pathologists as a prerequisite for the implementation of the optical biopsy~     method.~      In this study we want to proof that the use of a new narrow-band imaging (NBI) tool (Exera~     III, Olmpus) is capable to rise accuracy of optically ascertained diagnoses of colonic~     polyps. NBI is a light filter tool which can be activated by pressing a button at the~     endoscope. NBI function leads to an endoscopic picture which appears blue and enables~     endoscopists to better assess surface structures and vascular patterns.~      In a prospective randomised multicenter setting we plan to conduct colonoscopy in 380~     patients. Half of the patients will be examined without use of NBI (control arm). In these~     cases colonoscopists will assess optical diagnosis of polyps without turning on the NBI tool.~     If polyps are detected in patients belonging to the intervention arm NBI will be used and~     optical diagnosis will be determined using the NICE (NBI International Colorectal Endoscopic)~     classification. All polyps will be resected and send to pathology for further microscopic~     assessment. After completing the trial we aim to compare accuracy of the optical diagnosis in~     both groups. Our hypothesis is, that by using the new NBI tool accuracy (accordance between~     optical and histopathological diagnosis) can be increased from 78% to 90%.~   "
119015|NCT02009735|"~     To develop a real-time diagnostic technique with Virosensor for Enterovirus 71 and Influenza~     Virus detection, the investigators conduct a prospective clinical study. In comparison with~     results from direct sequencing of Enterovirus 71 and Influenza Virus, the investigators~     evaluate the performance of virosensor , including reproducibility, sensitivity, specificity,~     and cross-reaction. The potential factors which may interfere with the results would be~     investigated. With such technique, the investigators hope to make early diagnosis and give~     Enterovirus 71 and Influenza Virus patients early treatment to reduce the complications and~     case-fatality rate.~   "
119016|NCT02009722|"~     Both hydromorphone and morphine are administered as part of spinal anesthesia to help improve~     pain control after cesarean delivery. In this study, the investigators are going to determine~     the doses of each of those medicines that provides optimal pain control to women undergoing~     cesarean delivery while limiting side effects related to those medicines. The investigators~     hypothesize that the doses of hydromorphone and morphine that provide optimal pain control~     without significant side effects will be 100 micrograms and 150 micrograms, respectively. The~     investigators further hypothesize that at each respective optimal dose, side effects will be~     less in the hydromorphone group.~   "
119017|NCT02009709|"~     The primary objective of this study is to determine the effectiveness and safety of corneal~     collagen cross-linking at irradiance levels of 9 and 18 mW/cm2.~   "
119018|NCT02009696|"~     The objective of the ProMRI Study (Phase B) is to demonstrate the clinical safety of the~     ProMRI Pacemaker System when used under specific MRI conditions without scan exclusion zone.~   "
119019|NCT02009683|"~     In this study the investigators aim to build a model to predict the maintenance of sinus~     rhythm (SR) after successful direct current cardioversion (DCC) incorporating standard~     predictors such as echocardiographic parameters, clinical parameter and 12-lead ECG~     parameters and new parameters, including 17-lead ECG, Oesophageal-ECG and single nucleotide~     polymorphisms (SNPs). Using this novel integrated prediction model will help in the~     identification of patients who will maintain SR after cardioversion. Another innovative~     aspect of our study is the use of daily rhythm monitoring using a versatile device~     (MyDiagnostick®). The clinical impact this study will have is that it helps the cardiologist~     to make a patient tailored strategy in the treatment of AF as advocated by the guidelines and~     to prevent exposing patients not likely to maintain SR to the potentially harmful side-effect~     of a rhythm-control strategy.~      Primary objectives To show that a model incorporating the novel predictors 17-lead ECG,~     Oesophageal-ECG and SNPs is superior to existing models in predicting maintenance of sinus~     rhythm after successful DCC in patients with persistent AF.~      Secondary objectives To assess the predictive value of new predictors (the Oesophageal-ECG,~     17-lead ECG and SNPs) for maintenance of SR after successful DCC separately.~      To assess the predictive value of new predictors (the Oesophageal-ECG, 17-lead ECG and SNPs)~     for time to recurrence of AF.~      To assess the predictive value of predictors with respect to complete failure of~     cardioversion.~      To assess the predictive value of predictors with respect to cardiovascular morbidity.~      Hypothesis The investigators hypothesise that a model incorporating the novel predictors the~     17-leads ECG, Oesophageal-ECG and SNPs performs significantly better than existing models~     using only clinical, echocardiographic and ECG parameters on a standard 12-lead ECG in~     predicting maintenance of SR after successful DCC. In addition the investigators hypothesise~     that Oesophageal-ECG is the best single predictor for maintenance of SR after successful DCC.~   "
119020|NCT02009670|"~     In this placebo controlled, double-blind, randomized crossover study the investigators will~     investigate in overweight/obese healthy male volunteers whether inulin administration will~     increase intestinal SCFA production, thereby investigating whether this will lead to acute~     metabolic effects.~   "
119021|NCT02009644|"~     The purpose of this clinical trial is to assess and evaluate the safety and efficacy of the~     Treovance Stent-Graft with Navitel Delivery System in subjects with Abdominal Aortic~     Aneurysms (AAA).~   "
119022|NCT02009631|"~     This is a randomized Phase 1 study to evaluate the effects of Veliparib on cardiac~     repolarization in patients with solid tumors who's cancer has recurred or is no longer~     responding to current treatment.~   "
119023|NCT02009618|"~     To evaluate the efficacy of Rifaximin therapy started prior to completion of advanced~     examination procedure (before colonoscopy) of patients pre-diagnosed with irritable bowel~     syndrome, and implement it into clinical practice.~   "
119024|NCT02009605|"~     This study is designed to evaluate the efficacy of icotinib at routine dose in previously~     treated non/light-smoking patients with advanced squamous cell lung cancer.~   "
119025|NCT02009592|"~     Non alcoholic fatty liver disease (NAFLD) is a common cause of chronic liver disease, it~     encompasses from simple steatosis to non alcoholic steatohepatitis (NASH) and, eventually~     leads to cirrhosis and hepatocellular carcinoma (HCC). Dysbiosis, over nutrition, life style,~     type 2 diabetes (T2DM) and metabolic syndrome are main causes in the disease progression.~     Research on the role of gut-liver axis in the pathogenesis of NAFLD has been slowly~     accumulating over the past few years. Endotoxemia resulting from intestinal bacterial~     overgrowth may contribute to the pathogenesis of NAFLD. So, intestinal microbiota (IM) serve~     as a potential therapeutic target in NASH. In this regard, we have aimed to test the efficacy~     of rifaximin against simple steatosis (NAFLD) and steatohepatitis (NASH) subjects in relation~     to serum endotoxins and related pro-inflammatory cytokine levels. We hypothesis that~     Rifaximin treatment may influence the endotoxin levels by modulating gut microbiota and~     partial alleviate from NAFLD/NASH.~   "
119026|NCT02009579|"~     Indication:~      Treatment of subjects with advanced (FIGO stage IVB) or recurrent cervical cancer, prior~     radiochemotherapy or neo-adjuvant chemotherapy is allowed.~      Study design:~      This is a phase II randomized, double blind and placebo controlled trial evaluating the~     efficacy of Nintedanib/placebo in combination with the standard carboplatin and paclitaxel~     followed by Nintedanib/placebo maintenance in the treatment of patients with advanced or~     recurrent cervical cancer.~      A total of 120 patients will be randomized between the experimental and control arm in a 1:1~     ratio. Randomization will be stratified for 1previous chemotherapy for metastatic disease~     (yes/no) and 2disease status (Stage IVB primary versus recurrent disease).~      Experimental arm: Subjects will receive 6 cycles of 3-weekly carboplatin (AUC 5) + paclitaxel~     (175 mg/m2) and Nintedanib 200 mg BID followed by Nintedanib maintenance until progression or~     for a total maximum duration of 120 weeks.~      Control arm: Subjects will receive 6 cycles of 3-weekly carboplatin (AUC 5) + paclitaxel (175~     mg/m2) and placebo 200 mg BID followed by placebo maintenance until progression or for a~     total maximum duration of 120 weeks.~      Subjects without evidence of disease progression after completion or discontinuation of the~     study treatment will be followed until radiographic disease progression, withdrawal of~     consent or death.~   "
119027|NCT02009566|"~     Surgical sponges can be accidentally left inside patient's bodies. We are working on special~     tags (called microfabricated tags) that surgeons can put on their sponges. Then, if the~     surgeons forget to remove a sponge from a patient, they'll be able to detect these special~     tags in an x-ray.~   "
119028|NCT02009553|"~     Urodynamic study may lead to significant anxiety. Our hypothesis is that Urodynamic study is~     that pre-procedural explanation note about the test may reduce the anxiety level of the~     patients.~   "
119029|NCT02009540|"~     Overactive Bladder (OAB) is a chronic condition caused by instability of the detrusor or~     bladder muscle, which gives rise to symptoms of urinary urgency and often urinary~     incontinence. Idiopathic Detrusor Overactivity (IDO) is a subset of OAB where the cause for~     the bladder muscle instability is unknown.~      OAB is usually treated by conservative measures or with oral medications eg.~     anticholinergics. Injection of onabotulinum toxin A (onaBoNT-A) into the bladder wall is~     licenced in the treatment of refractory IDO where oral medications fail. The injected toxin~     paralyses the bladder by blocking the ability of certain (motor) nerves to communicate with~     the bladder muscle. As these nerves are mainly concentrated in what is known as the body of~     the bladder this is traditionally where the injections are given.~      In addition to its action on motor nerves, onaBoNT-A also affects sensory nerve pathways.~     Recent studies show that IDO is caused by both motor and sensory nerve dysfunction, therefore~     injecting the trigone, a part of the bladder where sensory nerves are particularly dense,~     may be of clinical benefit. Three studies comparing trigone versus trigone-sparing injection~     of botulinum toxin in the treatment of IDO have been carried out. One of these indicated a~     significant benefit in targeting the trigone and the other two did not show any difference.~      Our study aims to examine if injection of onaBoNT-A into the trigone alone will provide~     symptom and functional improvement in patients with IDO by comparing peritrigonal injection~     of onaBoNT-A with the traditional method of injection which spares the trigone.~   "
119030|NCT02009527|"~     The present project is designed to test the hypothesis that arginase contributes to~     endothelial dysfunction induced by ischemia-reperfusion in patients with coronary artery~     disease.~   "
119031|NCT02009514|"~     The purpose of this study is to investigate differences in glycemia~        -  during the whole hemodialysis day and the whole freeday~        -  during hemodialysis, during the evening and the night after hemodialysis and at the same~          time intervals during the freeday in an unselected type 2 diabetic patient group using~          both glucose-containing and glucose-free dialysate.~   "
119032|NCT02009501|"~     This study would like to determine if using negative pressure wound therapy with an~     instillation of .125% Dakins is more effective than using negative pressure wound therapy~     alone on biofilm removal, disruption and elimination in chronically infected lower extremity~     wounds.~   "
119033|NCT02009488|"~     The purpose of this study is to assess changes from baseline in insulin sensitivity, hepatic~     fat content and beta cell function after approximately 24-25 weeks of treatment with~     canagliflozin compared to placebo in participants with type 2 diabetes mellitus (T2DM) with~     inadequate glycemic (blood sugar) control on metformin monotherapy or on combination therapy~     with metformin and a dipeptidyl peptidase-4 (DPP-4) inhibitor.~   "
119034|NCT02009475|"~     The aim of the present study is to evaluate differential lactate removal kinetics in heart~     failure patients that are trained according to 2 different exercise protocols:~      (A) High intensity intervals training (HIT); (B) Continuous moderate aerobic training (MAT)~   "
119035|NCT02009462|"~     Artefill is an injectable facial filler device that is currently approved by the FDA for the~     correction of nasolabial folds. This study seeks to examine the use of Artefill in the~     treatment of HIV associated facial lipoatrophy. Facial lipoatrophy (facial fat loss) related~     to HIV is a stigmatizing condition characterized by loss of facial fat, most notably in the~     cheeks and temples.~   "
119036|NCT02009449|"~     This is a first-in-human, open-label, dose escalation study to evaluate the safety and~     tolerability of AM0010 in patients with advanced solid tumors, dosed daily subcutaneously as~     a monotherapy or in combination with chemotherapy or immunotherapy.~   "
119037|NCT02009436|"~     This pilot phase I trial studies the side effects and best dose of azacitidine in treating~     patients with lung cancer that is stage IV or has returned after previous treatments~     (recurrent). Azacitidine is a drug used in chemotherapy that may stop tumor cells from~     growing or spreading by activating genes that help prevent cancer growth, called tumor~     suppressor genes. As people age, these genes are silenced by a chemical reaction that occurs~     naturally in the body, or by exposure to environmental factors such as smoking. Azacitidine~     may help reverse this process and restore the function of the tumor suppressor genes.~     Delivering azacitidine directly into the lungs by inhalation may work better in treating lung~     cancer.~   "
119038|NCT02009423|"~     The objective is to compare the efficacy and safety of masitinib at 4.5 mg/kg/day to placebo.~   "
119039|NCT02009410|"~     maldigestion of dietary macronutrients (pancreas not producing enough enzymes for digestion~     of fat, sugars and proteins) in diabetes type II~   "
119040|NCT02009397|"~     The purpose of this study is to test the combination of Ipilimumab and GM-CSF. Both~     ipilimumab and GM-CSF are intended to work with the body's own immune system to attack~     melanoma cells in the body. This study will also demostrate how safe the combined drugs are~     when used to treat patients with Stage 3 or Stage 4 melanoma (metastatic melanoma), which~     cannot be removed by surgery.~   "
119041|NCT02009384|"~     This is an open-label, clinical efficacy study of Ipilimumab in patients with Stage IIIC and~     Stage IV melanoma who have recently been treated with Denileukin Diftitox. Approximately 42~     patients with radiographically measurable melanoma who have received at least one cycle of~     Denileukin Diftitox will be enrolled and treated in the study.~   "
119042|NCT02009371|"~     The purpose of this study is to investigate the efficacy and safety of light-emitting~     diode(LED) light therapy on Chinese patients with Depressive Episodes of Bipolar Disorder and~     to gather prime research data and application parameters of LED light source which is not~     currently available in China.~   "
119043|NCT02009358|"~     The goals of this research were to conduct a mental health intervention study for reducing~     self-reported depression and anxiety among migrant workers in a labor-intensive industry in~     China and to assess the effectiveness of the integrated mental health interventions aimed at~     promoting the mental health of migrant workers in labor-intensive industries in China.~   "
119073|NCT02008968|"~     Several studies showed that hyperuricemia is an independent risk factor for development of~     diabetes mellitus. However none of the previous studies have investigated the effect of~     lowering serum uric acid levels on insulin resistance of which is also named as prediabetes.~     With this background in mind, we aimed to test the effect of lowering serum uric acid level~     with allopurinol on insulin resistance.~   "
119074|NCT02008955|"~     The lysine requirement of elderly female subjects 65-75 years old will be 40-45 mg/kg/day.~   "
119044|NCT02009345|"~     Familial hypercholesterolemia (FH) is the most frequent genetic lipoprotein disorder~     associated with premature CAD. In Canada, the burden of disease is estimated to be~     approximately 83,500 patients. The goal of this initiative is to create a registry of~     subjects with FH across Canada. Rare diseases of lipoprotein metabolism will also be~     included. Using a hub and spoke model, the registry will be extended in various communities~     to link primary care physicians with provincial academic centers. The registry will include~     clinical, biochemical and demographic information. Specimens (plasma/serum and DNA) will be~     collected for biobanking. We propose a three-tier registry: local, provincial and~     Canada-wide, which will be completely anonymized. The registry will be made available for~     clinicians to manage patient care, identify relatives for screening and treatment (cascade~     screening), to provide advice to general practitioners and to support collaborative studies~     in biomedical, clinical, health outcomes and health economics research. The data extracted~     for the provincial portion of the database will allow administrative database research that~     will provide important information to key stakeholders and permit allocation of resources. It~     will also allow a sound and uniform rationale for the use of novel therapeutic agents and~     provide expert advice to regulatory agencies. At the Canadian level, the database will allow~     clinicians and researchers to determine the burden of disease and the long-term effects of~     treatment. Through the creation of a Canada-wide network of academic clinics, integrating~     lipid specialists, endocrinologists and cardiologists, the Canadian FH registry will lead to~     significant benefits for FH patients, clinicians and researchers, biopharmaceutical industry~     and government.~   "
119045|NCT02009332|"~     Purpose of this study is to determine appropriate dosing of ABI-009 and evaluate the safety~     and anti-tumor activity of ABI-009 in treatment of non-muscle invasive bladder cancer~   "
119046|NCT02009319|"~     The aim of this pilot study is to evaluate EBUS elastography strain ratio in assessment of~     mediastinal lymph nodes in patients with suspicion for lung cancer for the first time. Strain~     ratios of mediastinal lymph nodes will be compared with EBUS B-mode features and with tissue~     diagnosis as a gold standard.~   "
119047|NCT02009306|"~     When patients are dying they become unable to take oral medication and if they develop~     symptoms (e.g. pain or agitation) they need to be given a subcutaneous injection of~     medication. If they are at home this requires that a District Nurse is called and it can take~     a long time (sometimes hours) for the Nurse to arrive. This can be a very stressful time for~     the patient and family.~      There are 2 drug preparations which could potentially be given by family members in the home:~      Nasal fentanyl (PecFent) Buccal midazolam (Epistatus) If these preparations helped symptoms~     this would give much quicker symptom control for patients and might mean the District Nurse~     visit was not needed.~      In advance of a community based randomised trial of these modes of administration, it is~     important to assess the feasibility of such an approach in terms of carer acceptability and~     patient tolerability as well as determine appropriate sample sizes and sampling methods.~     There are 2 work packages which would help assess feasibility of a community trial:~        1. An open label randomised controlled trial comparing the use of PecFent with or without~          Epistatus versus standard subcutaneous breakthrough medication for the management of~          breakthrough pain (with or without agitation) in dying hospice patients who either~          remain in the hospice or go home.~        2. A qualitative interview study to capture the thoughts of relatives of these patients~          about the use of these preparations.~   "
119048|NCT02009293|"~     In this study we evaluate the effect of Pirfenidone on cough and quality of life in patients~     with idiopathic pulmonary fibrosis (IPF) that are treated with Pirfenidone in daily practice.~     The hypothesis is that Pirfenidone will decrease cough and increase quality of life.~   "
119049|NCT02009280|"~     The aim of this study is to investigate whether propofol based total intravenous anesthesia~     reduces incidence of acute kidney injury following the lung transplantation under~     extracorporeal membrane oxygenation~   "
119050|NCT02009267|"~     A retrospective chart review study analyzing the benefits of patient controlled analgesia,~     thoracic epidural analgesia, and paravertebral nerve block catheters in patients having~     surgical repair of pectus excavatum using the Nuss procedure.~   "
119051|NCT02009254|"~     Potato is one of the world's most popular foods and is widely accepted as a staple food. The~     objective of this study is to determine the effect of consuming instant mashed potatoes with~     and without fat on glycemic response, subjective appetite and food intake. It is hypothesized~     that mashed potato with added fat (as it is usually consumed) will result in lower glycaemic~     response and subjective appetite, and reduced subsequent food intake.~   "
119052|NCT02009241|"~     Lymphangioleiomyomatosis (LAM) is a rare disease in which reduced exercise capacity is~     frequently present. The mechanisms applied are airflow obstruction, abnormal diffusion~     capacity and dynamic hyperinflation (DH).~      Pulmonary rehabilitation (PR) has proved benefit in improving exercise tolerance, dyspnea,~     and quality of life in chronic obstructive pulmonary disease. There are no studies evaluating~     the impact of PR in patients with LAM.~      The hypothesis under study is that PR determine improvement in exercise capacity, dyspnea,~     quality of life, muscle force, functional limitation and DH in these patients.~   "
119053|NCT02009228|"~     Minimally invasive surgery has become the standard treatment for many gynecologic disease~     processes. In the last decade, numerous studies have demonstrated that laparoscopic~     approaches to various gynecologic oncology conditions-particularly for early-stage~     endometrial and cervical cancers as well as select pelvic masses-is feasible and results in~     shorter hospital stays, improved quality of life and comparable surgical and oncologic~     outcomes to abdominal staging.For instance, the typical gynecologic robotic surgical~     procedure will require Two to three 5-mm ports and one 12-mm laparoscopic ports. Recently, an~     even less invasive alternative to conventional laparoscopy surgery has been developed:~     laparoendoscopic single-site surgery (LESS), also known as single-port surgery. Single port~     laparoscopy is an attempt to further enhance the cosmetic benefits of minimally invasive~     surgery while minimizing the potential morbidity associated with multiple incisions.~     Preliminary advances in LESS as applied to urologic and gastrointestinal surgery demonstrate~     that the techniques are feasible provided that both optimal surgical technical expertise with~     advanced skills and optimal instrumentation are available. Recently, several publication~     showed the single port laparoscopic surgery is feasibility in gynecologic surgery including~     oophorectomy, cystecomty, and myomecomty. To our knowledge, the sample size of recent~     publication about single port surgery including cystectomy and myomecomty is small.~     Furthermore, these studies lack the comparison of single port and convectional laparoscopic~     surgery. Base on our recent study demonstrated that either the single-port or the~     conventional approach can be used for LAVH, but the single-port LAVH technique yielded less~     postoperative pain (Chen et al., Obestet Gynecol, 2011). The purpose of this study was to~     assess the feasibility of single port laparoscopic surgery in the treatment of benign~     gynecologic disease.~   "
139648|NCT01739465|"~     The purpose of this study is to compare endoscopic radiofrequency ablation with photodynamic~     therapy for inoperable cholangiocarcinoma~   "
119054|NCT02009215|"~     We propose to evaluate the community-level impact of intermittent preventive treatment (IPT)~     for malaria in schoolchildren on clinical outcomes and malaria transmission, using a~     cluster-randomised design in Jinja, Uganda. Dihydroartemisinin-piperaquine (DP) will be~     administered to schoolchildren monthly for up to six rounds of treatment during one school~     year. Outcomes will be measured using surveys of communities, schoolchildren, and mosquito~     vectors. Our proposal also includes health service research to evaluate the potential~     feasibility of taking the programme to scale, which will guide future research and~     implementation of the intervention, and help shape policies in Uganda and elsewhere in~     Africa.~   "
119055|NCT02009202|"~     Colonoscopy is a routinely performed examination of children and adolescents in the~     diagnostic process of inflammatory bowel disease (IBD). It is necessary that the bowel is~     clean so the colonoscopy can be optimally performed. The cleansing of the bowel by means of~     laxatives prior to the examination is, however, considered difficult by many children.~     Getting smaller children to cooperate and to drink a substantial volume of laxative fluid~     prior to the examination can be particularly difficult. There are several possible cleansing~     procedures and combinations of procedures for the cleansing of the colon, for example by~     means of polyethylene glycol and sodium picosulphate, which are the two most commonly used~     methods. Cleansing by means of polyethylene glycol can, due to the necessary intake of a~     substantial quantity of fluid, be particularly frustrating for patients. Often the only way~     to carry out the preparation is with the insertion of a nasogastric tube, which can cause~     discomfort for some children. Cleansing the colon by means of sodium picosulphate, which~     involves an intake of a small quantity of fluid, has been suggested to be a good sufficient~     method resulting with a satisfactory result in terms of bowel cleanliness. However, studies~     have so far encompassed only a smaller number of children and further studies are needed to~     confirm that there is no difference between the two methods in terms of resultant bowel~     cleanliness.~      The purpose of this randomized controlled study is to compare preparation by means of~     polyethylene glycol and preparation with sodium picosulphate prior to colonoscopy in~     children.~      One hundred children scheduled for colonoscopy in southern Sweden will be randomized into~     either patient group 1 (for preparation with polyethylene glycol) or patient group 2 (for~     preparation with sodium picosulphate). For the random sampling, data-driven selection will be~     implemented. A CONSORT Flowchart (2012) will be encompassed by the study. To assess the~     cleanliness of the intestinal tract (and volume of fluid in the intestine), the Ottawa Scale~     will be used (Rostom & Jolicoeur, 2009). All colonoscopy examinations will be performed by~     the same paediatric gastroenterologist, to whom no information about which preparation method~     was used by each child will be disclosed. Furthermore, the gastroenterologist will, meet with~     the children first after the investigation has been completed. All information regarding the~     investigation will be given to the patient by the admitting physician. During the colonoscopy~     the gastroenterologist will evaluate the intestinal cleanliness and submit the reports in~     sealed coded envelopes to the nurse in charge of the patient.~   "
119056|NCT02009189|"~     Taurolidine alone or in combination with citrate have been proposed for locking the catheter~     to reduce the number of catheter infections. As there is not enough evidence to give~     recommendations in this regard, the study tested the hipothesis that taurolidine improves the~     outcome of long term paretneral nutrition.~   "
119057|NCT02009176|"~     The purpose of this study is to compare short-term and long-term efficacy of two surgical~     methods by laparoscopic hepatectomy, and provide the evidence for the choice of surgical~     method from the pathology and cytology.~   "
119058|NCT02009163|"~     To evaluate maintenance of efficacy based on time to relapse between SPD489 (50 or 70mg) and~     placebo, as measured by the number of binge days (defined as days during which at least 1~     binge episode occurs) per week as assessed by clinical interview based on subject diary and~     Clinical Global Impression - Severity (CGI-S) scores for patients who responded to SPD489 by~     the end of the Open-label Treatment Phase.~   "
119059|NCT02009150|"~     Three-dimensional functional Metabolic Imaging (3D MIRA) is a new infrared imaging technology~     using the Real Imager 4(RI4) developed by Real Imaging. This technology generates 3D~     metabolic maps and based on sophisticated machine learning technology, provides objective~     risk assessment for the presence of malignant tumor. The procedure is non-invasive,~     comfortable and does not involve ionizing radiation. Moreover, Real Imaging's 3D Functional~     MIRA is unaffected by breast density and is therefore ideal for evaluating patients with~     mammographically dense breasts.~      The purpose of this clinical study is to assess the ability of this novel technology to~     detect clinically occult breast cancer in a cohort of women that are at high risk for breast~     cancer.~      We hypothesize that the combination of screening mammography and metabolic screening (3D~     MIRA) will result in significantly higher breast cancer detection rates.~   "
119060|NCT02009137|"~     Expected Total Number of Subjects~        -  Level of significance, alfa 0.05~        -  Power 0.80~        -  Mean difference between two treatments is assumed 35~        -  Standard Deviation is assumed 35.~        -  Follow-up loss is assumed 20%~        -  N=34(each group:17)~   "
119061|NCT02009124|"~     The purpose of this study is to study the effect of stem cell therapy on common symptoms in~     patients with spinal cord injury.~   "
119062|NCT02009111|"~     Couple CARE for Parents is a couple-focused intervention that addresses interpersonal~     processes within relationships and promotes relationship and parenting skills among couples~     with a newborn. Couple CARE for Parents uses an approach developed in Australia that was~     designed to be fairly easy and cost-effective to disseminate widely (i.e., home-visitation~     and video- and telephone-assisted skills training). It has demonstrated efficacy for~     significantly enhancing couples' relationship satisfaction in three Australian randomized~     trials.~      Arresting the normal decline of satisfaction of new parents to near-clinical levels is~     noteworthy because relationship dissatisfaction is one of the strongest predictors of partner~     physical assault. Managing relationship conflict is critical to the health and well-being of~     both parents and their children. Given the high prevalence of partner physical and emotional~     aggression (a precursor to the more serious form labeled intimate partner violence [IPV])~     in new parents) among perinatal parents, the need for efficacious prevention services is~     acute.~      This randomized, controlled trial will test if couples with a newborn who receive Couple CARE~     for Parents report significantly less IPV than control couples who do not receive the~     program. This is a prevention trial. No couple will report ever having experienced IPV. All~     couples will have three empirically documented risk factors for the development of IPV: youth~     (each couple will have at least one partner under 30 years of age), parenting a newborn, and~     psychological aggression in the past year.~      The project has the following aims: (1) Determine the outcomes of Couple CARE for Parents.~     The investigators hypothesize that, among other positive outcomes, couples who receive Couple~     CARE for Parents, compared with those who do not, will report at follow-up (a) less IPV; and~     (b) less partner physical and emotional aggression. (2) Identify factors that may contribute~     to reduction in IPV and in physical and emotional aggression (e.g., communication skills,~     conflict behaviors, parenting expectations, , quality of adult attachment, partner~     attributions, child abuse potential, family income, marital status, parenting stress, infant~     difficultness).~   "
119075|NCT02008942|"~     This study will determine if aspirin from PL2200, an investigational product, gets into the~     blood stream as quickly as enteric coated aspirin, and to test whether PL2200 is able to~     prevent blood clots as effectively as enteric coated aspirin, when administered to patients~     with diabetes~   "
119076|NCT02008929|"~     To see the safety and efficacy of injecting MG4101 as a secondary treatment after curative~     liver resection on the patient with advanced HCC who has high risk of recurrence.~   "
119077|NCT02008916|"~     The purpose of this study is to generate 16-week efficacy data, as well as up to 3-year~     efficacy, safety and tolerability data in subjects with active AS despite current or previous~     NSAID, DMARD and/or anti-TNF therapy.~   "
119266|NCT02006446|"~     In men presenting sperm alterations, the selection of genetically undamaged spermatozoa need~     to be improved in order to increase the success of assisted reproduction treatments.~      The aim of this study is to determine whether the presence of sperm head vacuoles is~     associated with sperm DNA alterations.~   "
119063|NCT02009098|"~     Background Women undergoing Caesarean Section (CS) have an increased risk of postpartum~     infections compared to women undergoing vaginal delivery. In Denmark the incidence of post-CS~     infections is 7-10%. The most common infections are endometritis, Urinary tract infections~     (UTI) and wound infections (WI).~      Prophylactic antibiotics are effective in preventing postoperative infections and national~     guidelines recommend that antibiotics should be administered as a single dose immediately~     before surgical incision. CS is an exception to this pre-incision administration approach.~     National guidelines recommend administration of antibiotics after umbilical cord clamping to~     avoid exposure of the child to antibiotics before birth. Recent studies of antibiotic~     prophylaxis for CS suggest that prophylactic antibiotics administered before incision~     compared to after umbilical cord clamping may reduce post-CS infections by up to 50%. Two~     Cochrane reviews from 2012 criticize these types of studies for lack of data for outcomes on~     the baby and on late infection in the mother.~      This study is a double-blinded randomized controlled trial with a concurrent Health Economic~     Assessment. The study will examine the effect of change in timing of prophylactic antibiotics~     on the rate of post-CS infections (endometritis, UTI and WI). The study will be performed at~     the obstetric departments at Odense University Hospital (OUH), Hvidovre Hospital (HH) and~     Hospital South West Jutland (HSWJ) in collaboration with the Department of Clinical~     Microbiology, OUH, to ensure that the most appropriate antibiotic regime is used.~     Furthermore, collaboration with a neonatologist will ensure appropriate assessment of~     neonatal outcome.~      The investigators plan to enroll the first patient at OUH February 2013. HH and HSWJ will~     follow with a couple of months delay. The inclusion period is scheduled to last until the~     investigators have 2844 participants, who have answered the questionnaire. The investigators~     expect to complete the inclusion period in October 2014 (last patient last visit, LPLV).~     Microbiological analyzes and data processing is expected to be completed one year after the~     LPLV. The study population is all women delivering a child by CS during the project period,~     at Department of Gynaecology and Obstetrics of OUH, HH and HSWJ.~      Objective: Investigate whether and by how much antibiotics administered 15-60 minutes before~     incision versus after umbilical cord clamping reduces the rate of postpartum infections in a~     Danish population of women undergoing CS.~      Hypothesis: Antibiotics administered pre-incision will result in fewer postoperative~     infections than antibiotics administered after the umbilical cord is cut.~      Hypothesis: Antibiotics administered before incision are cost-effective, compared to~     administration after umbilical cord clamping, measured by post-CS infection and as cost per~     Quality Adjusted Life Year (QALY).~   "
119064|NCT02009085|"~     In this study a fluorescent contrast dye is applied to a suspicious skin lesion.~      Images are acquired and processed. The information is used to develop a prediction model for~     the presence of malignant transformation in the skin.~   "
119065|NCT02009072|"~     Pterygium is a common ocular pathology facing ophthalmologists that has varied surgical~     management techniques and high rate of post-operative recurrence. The investigators aim was~     to compare and evaluate the safety and efficacy outcomes of those two surgical procedures in~     management of primary pterygium.~   "
119066|NCT02009059|"~     In pre-hospital care, there are few non-invasive thermometers that are proved both robust and~     accurate. The aim of this study is to investigate the accuracy of a certain ear-canal based~     thermometer on patients undergoing thoracic surgery in deep hypothermia.~   "
119067|NCT02009046|"~     This study examines the effectiveness of the Sexuality Education Initiative (SEI), a~     comprehensive, multi-component, rights-based sexuality education program developed and~     implemented by Planned Parenthood Los Angeles for high school students. The primary goal of~     the SEI is to improve the sexual and reproductive health of youth attending Los Angeles high~     schools. The SEI consists of four intervention components: (1) a 12-session gender-sensitive,~     rights-based, comprehensive sexuality education curriculum, (2) a peer education and advocacy~     component, (3) a parent education component, and (4) clinical services linkages. It is~     hypothesized that the 12-session classroom curriculum is more effective than a 3-session~     control sex education curriculum. It is also hypothesized that the full SEI package (all four~     components) is more effective than the control condition (control curriculum and clinical~     services only).~   "
119068|NCT02009033|"~     The purpose of this study is to investigate the effect of thin fluid with starch versus thin~     fluid without starch on coagulation in elective surgery when the patient is normovolæmic~     during operation.~   "
119069|NCT02009020|"~     Dynamic parameters like pulse pressure Variation (PPV) , synonymous: difference in pulse~     pressure (dPP), can predict fluid responsiveness reliably (Marik PE et al, Crit Care Med~     2009; 37:2642-7). An arterial line is required for assessment of dPP. On a modified Penaz~     technique, a non-invasive measurement device is now available commercially. In this study,~     the reference technique based on arterial measurement and a respiratory variation monitor~     (Pestel G et al, Anesth Analg 2009; 108:1823-9) was compared to the non-invasive device a~     clinical setting. At defined time points, systolic, diastolic, mean arterial blood pressure~     and dPP were compared using Bland-Altmann Analysis (Bland JM, Altman DG, Lancet 1986; 1:~     307-10)~   "
119070|NCT02009007|"~     Liberal fluid administration is one of risk factors of developing acute lung injury (ALI) in~     thoracic surgery. Therefore, the investigators try to restrain fluid administration, and in~     the case of intraoperative hypotension, the investigators often administer vasoactive agents~     or inotropes. One lung ventilation (OLV) which is routinely employed for thoracic surgery~     decrease arterial oxygenation and oxygen delivery to brain can be also decreased. In this~     study, the investigators compared dopamine and phenylephrine in respect to maintaining~     cerebral oxygen saturation in major thoracic surgery. The investigators hypothesis is that~     dopamine is better than phenylephrine to maintain cerebral oxygen saturation in thoracic~     surgery.~   "
119071|NCT02008994|"~     Genes are the basic instruction book for the cells that make up our bodies and are made out~     of DNA. Many research studies are done to find the best possible way to treat patients with~     cancer. Recently there has been a great deal of interest in developing new anticancer agents~     that are more targeted to a patient's individual genetic information, as well as diseases~     caused by defects in a person's genes.~      Identification of precisely which treatments to use against a specific patient's tumor is~     challenging. In this study, four cutting-edge technologies will be used to identify genomic~     (information we get from DNA and RNA) and proteomic (information we get from proteins)~     targets for the treatment of your tumor. These four tests will be used together to gather~     information about your tumor giving doctors and scientists a better understanding of the~     structure of your tumor and what the best treatment or combination of treatments may be for~     you. The therapy you receive to treat your tumor will be based on your medical history,~     previous treatments for your disease if applicable, current state of health, and the findings~     from these four tests. The therapy you ultimately receive will be selected by your doctor in~     consultation with a panel of experts in cancer and cancer genomics (the Treatment Selection~     Committee).~   "
119072|NCT02008981|"~     This is a research study on the effect of some commonly used blood activating herbal~     products on platelet function and coagulation profile, ie whether it causes an increase in~     bleeding tendency, either used alone or in combination with Aspirin which is a commonly used~     anti-platelet drug.~   "
119112|NCT02008461|"~     The investigators have conducted a prospective, double-blind, randomized study to assess the~     comparative safety and efficacy of two different ablation strategies, RFA versus RFA plus~     botulinum toxin injection, in patients with supra-ventricular tachyarrhythmias. Results were~     assessed with the use of an implanted monitoring device (IMD).~   "
119078|NCT02008903|"~     The overall goal of this study is to develop a novel minimally invasive device, the~     Esophageal String Test (EST) to monitor esophageal inflammation during treatment of the rare~     disease Eosinophilic Esophagitis (EoE) in a safe and efficacious manner.~      This study is broken down into 2 specific aims:~      Specific Aim 1: Identify the EoE Biomarker Panel (EBP) that will improve the sensitivity and~     specificity of the EST for documenting esophageal inflammation in a 1-hour time point.~      Specific Aim 2: Validate the ability of the EST EBP to monitor therapeutic efficacy in a~     1-hour sampling time.~      Funding Source - FDA OOPD~   "
119079|NCT02008890|"~     Was to demonstrate superiority of secukinumab compared to placebo in patients with moderate~     to severe chronic palmoplantar pustular psoriasis with respect to the palmoplantar pustulosis~     Psoriasis Area and Severity Index 75 response rate~   "
119080|NCT02008877|"~     Phase 1: To assess the safety, tolerability, and maximum tolerated dose (MTD)/ recommended~     dose of ganetespib when administered in combination with sirolimus in patients with~     refractory or relapsed sarcomas including unresectable or metastatic sporadic or~     neurofibromatosis type 1 (NF1) associated MPNST. Phase I enrollment has been closed.~      Phase 2: To determine the clinical benefit of ganetespib in combination with sirolimus for~     patients with unresectable or metastatic sporadic or NF1 associated MPNST.~   "
119081|NCT02008864|"~     Uremic pruritus remains one of the most frustrating and potentially disabling symptoms in~     patients with end stage renal disease. It affect up to 90 percent of patients with end stage~     renal disease. Several hypotheses have been postulated for the possible underlying etiology,~     but none is conclusive. Aside from kidney transplantation, which is only definitive~     treatment, therapeutic approaches have largely been empirical, and no firm evident‐base~     treatments are available. The main goal of therapy remains to minimize severity of pruritus.~     In Iranian traditional medicine Cassia senna L. is used for healing uremic pruritus . In this~     study investigators considered to evaluate effect of Cassia senna L. in uremic pruritus by a~     double blind placebo control clinical trial. It is hypothesized that oral Cassia senna L. may~     attenuate uremic pruritus by decreasing serum IL‐2, IFN-γ and TNF‐α.~   "
119082|NCT02008851|"~     The purpose of this study is to determine if selected renal cells, obtained by biopsy from a~     patient with chronic kidney disease (CKD) and Type 2 Diabetes (i.e., autologous cells) can be~     safely implanted back into the patient.~   "
119083|NCT02008838|"~     To evaluate the effects of synbiotic supplementation on insulin resistance, and lipid profile~     in subjects with metabolic syndrome, in a randomized, double-blind, placebo-controlled pilot~     study, 38 subjects with metabolic syndrome will be supplemented with either synbiotic or~     placebo capsules twice/day for 28 weeks. Both the synbiotic (G1) and the placebo (G2) groups~     will be advised to follow an energy balanced diet and physical activity recommendations.~     Parameters related to metabolic syndrome and insulin resistance will be measured every 7~     weeks during the study course.~   "
119084|NCT02008825|"~     We hypothesize that using the ViSiGi™ Calibration Tube System in patients undergoing LSG~     will:~        1. enhance delineation of the stomach anatomy and the surgeon's appreciation of the extent~          of gastric volume to be removed;~        2. increase the safety profile of the patient (i.e., reduce the likelihood of accidental~          stapling of the orogastric tube or bougie);~        3. reduce the incidence of OR contamination/infection transmission;~        4. streamline OR workflow, resulting in reduced OR time; and~        5. ensure consistent and reproducible staple lines.~   "
119085|NCT02008812|"~     To develop a real-time diagnostic technique with Ad sensor for Adenovirus detection, the~     investigators conduct a prospective clinical study. In comparison with results from direct~     sequencing of Adenovirus, the investigators evaluate the performance of Ad sensor , including~     reproducibility, sensitivity, specificity, and cross-reaction. The potential factors which~     may interfere with the results would be investigated. With such technique, the investigators~     hope to make early diagnosis and give Adenovirus patients early treatment to reduce the~     complications and case-fatality rate.~   "
119086|NCT02008799|"~     Azoospermia due to low sperm production (non-obstructive azoospermia) affects approximately~     1% of the male population and 10% of men who seek fertility evaluation. Testis biopsy reveals~     that these men have Sertoli cell-only pattern, maturation arrest, or hypospermatogenesis.~     Until recently, it was assumed that men with non-obstructive azoospermia were untreatable.~     Indeed, these patients were often referred to as being sterile or having testicular~     failure. We start to use stem cell in treatment of such patients by injecting the stem cell~     at the testis and the testicular artery in one group and at the testis only in other group~   "
119087|NCT02008786|"~     An emerging cause of heart attack in young women is a dissection (or tear) in the coronary~     arteries. Many of these young women continue to have chest pain long after the tear has~     healed and this is thought to be due to problems with their small blood vessels of the heart~     (or microcirculation). We want to determine whether commonly used medications for coronary~     artery disease including statins (for cholesterol) and angiotensin-converting enzyme~     inhibitors (for blood pressure) reduce chest pain and improve small vessel function in these~     patients.~   "
119088|NCT02008773|"~     The primary aim of the study is to determine the efficacy of adjunctive valacyclovir, in~     comparison to placebo, to improve visual (Brief Visuospatial Memory Test) and working~     (composite score of the Spatial Span and Letter Number Span tests) memory in individuals who~     are HSV-1 positive and early in the course of schizophrenia.~      We hypothesize that individuals who are HSV-1 positive, but not those who are HSV-1 negative,~     will demonstrate significant valacyclovir efficacy for visual and working memory.~   "
119089|NCT02008760|"~     The aim of this project is investigation of patients' with chronic pain self-rated quality of~     life, ADL function and level of pain before and after 3 months of intervention with N-3 fatty~     acids from krill in combination with vitamin D3. Furthermore, the compliance of the patients~     and the effect of the intervention on the patients' vitamin D status and cardiovascular risk~     factors are studied.~   "
119090|NCT02008747|"~     Atrial fibrillation and chronic neuropathic pain are adverse events occurring after~     posterolateral thoracotomy for lung resection. The continuous application of magnesium~     sulphate may have a prophylactic effect. The investigators record the incidence of atrial~     fibrillation during a seven day period after thoracotomy as well as the incidence of chronic~     neuropathic pain during a three months period, comparing one group with a continuous~     application of magnesium sulphate against one group without magnesium sulphate.~   "
119091|NCT02008734|"~     This is a Phase II study trying to identify whether short term treatment with PD0332991~     yields anti-proliferative response -defined by a low level of Ki67 expression (IHC) at~     surgery- or induces senescence as determined by SABG expression (IHC) in tumors from patients~     with early breast cancer non-candidates for neoadjuvant hormonotherapy or chemotherapy, as~     compared to no treatment.~   "
119092|NCT02008721|"~     MSA is a rapidly progressive disorder with an average survival time of about 7 years after~     the first clinical manifestation. No potent symptomatic treatment is currently available. A~     disease-modifying therapy does not exist either. The growing understanding in recent years of~     the underlying pathological mechanisms of the disease allows the development of new treatment~     options that have a modifying effect on the disease progression. Therefore, treatments are~     urgently required that effect the central underlying pathological mechanism, which appears to~     be the intracellular aggregation of toxic oligomers of α-synuclein.~      EGCG, a polyphenol found in green tea, has shown to inhibit the formation of toxic~     α-synuclein oligomers in vitro and has shown to transform α-synuclein-oligomers in non-toxic~     oligomer species. There is also evidence for a neuroprotective effect in MPTP-mouse models of~     PD and is an antioxidant and iron chelator. There are currently 63 clinical studies~     (http://clinicaltrial.gov) in which EGCG was applied for various indications, such as~     Multiple Sclerosis, various forms of cancer and Huntington's disease. All of which have shown~     good tolerability and safety with the applied doses of EGCG of up to 1200 mg per day,~     demonstrating the safety of the drug under controlled clinical conditions (see 5.3.1 for~     hepatotoxicity in uncontrolled conditions).~      These data provide a solid rationale for testing in a clinical trial if supplementation of~     EGCG can interfere with the core disease mechanism in MSA and consequently retard the~     clinical progression of the MSA-related disability.~   "
119093|NCT02008708|"~     The objective is to test the effectiveness of a village-led microfinance program, Pigs for~     Peace, on health, household economic stability, and reintegration of trauma survivors to~     family and community.~      The five-year experimental trial will use mixed-methods to address the following aims:~        1. Determine the effectiveness of a village-led microfinance program on participants health~          and reintegration in intervention households compared to participants in delayed control~          households. Health and reintegration will be measured at baseline and six, twelve, and~          18-months post-baseline using self-report in both intervention and delayed control~          groups. We hypothesize that at six, twelve and 18 months post-baseline participants in~          intervention households will have improved health and increased reintegration to~          families in comparison to participants in control households.~        2. Determine the effectiveness of a village-led microfinance program on household economic~          stability in intervention households compared to delayed control villages. Household~          economic stability will be measured at baseline and six, twelve and 18 months post-~          baseline using self-report in both intervention and control households. We hypothesize~          that at six, twelve and 18-months post-baseline the intervention households will have~          improved household economic stability in comparison to control households.~        3. Examine the role of a village-led microfinance program on village-level health,~          economics, stigma and reintegration of survivors and their families in intervention and~          delayed control villages. Village members (n=5 in each village, n=50 total) will~          complete a baseline and 18 month post-baseline qualitative interview to examine the role~          of microfinance on village-level health, economics, stigma and reintegration in both~          intervention and control households.~   "
119094|NCT02008695|"~     The investigators will test the effectiveness of a youth-led animal husbandry microfinance~     program, Rabbits for Resilience, combined with the adult microfinance, Pigs for Peace (PFP),~     program on youth, family and community resilience outcomes. The following aims will be~     completed over the five-year longitudinal, mixed-method, cluster randomized community trial:~      Specific Aim 1: Determine the relative effectiveness of a youth-led microfinance combined~     with the adult microfinance on youth and family resilience outcomes (reduced mental health~     distress, increased economic stability, improved family functioning) compared to a youth-led~     microfinance only and adult microfinance only approaches.~        -  We hypothesize that at six, twelve and 18-months post-baseline youth and adults in~          households in the youth-led and adult microfinance approach will report improved~          individual and family resilience outcomes compared to households in the youth-led~          microfinance only and adult microfinance only approaches.~      Specific Aim 2: Determine the relative effectiveness of a youth-led microfinance combined~     with PFP microfinance on community resilience (e.g. social capital and participation in~     community groups by youth and adults) compared to youth-led microfinance only and adult~     microfinance only approaches.~        -  We hypothesize that at 18-months post baseline in households in the youth-led and adult~          microfinance will report improved community resilience compared to households in the~          youth-led microfinance only and adult microfinance only approaches~      Specific Aim 3: Determine if changes in youth resilience (caregiving ability, empathy and~     outlook for the future) mediate the relationship between youth engagement in microfinance and~     outcomes, as measured by reduced mental health distress, improved family functioning and~     improved social capital.~      Specific Aim 4: Examine youth perspectives on resilience in the context of multiple~     adversities (war, poverty, loss of family, displacement, victimization). Youth participants~     (N=50, ages 10-15 years) will be invited (with parent/caregiver consent) to complete at~     baseline and 18 month post-baseline qualitative interview/group discussion to examine~     individual, family and community resilience and what that they perceive as key to buffering~     the negative health and social consequences of prolonged conflict and other adversities.~   "
119095|NCT02008682|"~     This trial is conducted in Asia. The aim of this trial is to investigate the efficacy and~     safety of liraglutide compared to sitagliptin, both as add-on to metformin in Chinese~     subjects with type 2 diabetes inadequately controlled on metformin monotherapy. Eligible~     subjects will continue their metformin background treatment during the trial.~   "
119096|NCT02008669|"~     Multiple sclerosis (MS) is a chronic progressive neurological disease, the leading cause of~     disability after injury accidents in young adults. Among the many symptoms, fatigue is very~     common with a significant impact on quality of life. Also, the disability caused by multiple~     sclerosis can alter food intake and can cause nutritional deficiencies. Nutrients such as~     proteins, minerals (iron, calcium, magnesium), some vitamins (B12, 25 OHD) are often~     deficient in this population with consequences in physical performance such as endurance and~     muscle strength. We propose to study the link between fatigue and shortcomings encountered in~     a defined population of MS patients.~   "
119097|NCT02008656|"~     The study is designed to test the hypothesis that patients with Locally advanced rectal~     cancer ( LARC) treated with Total neoadjuvant therapy (TNT) and Total mesorectal excision~     (TME) or Non-operative management (NOM) will have an improved 3-year disease-free survival~     (DFS) compared to patients with similar tumors treated with Chemoradiation therapy (CRT),~     Total mesorectal excision (TME) and Adjuvant chemotherapy (ACT).~   "
119098|NCT02008643|"~     The number of studies concerning health related quality of life (HRQL) in children with food~     allergy is very limited.~      Only one study to date has compared HRQL of a group of children with food allergy to data~     published on general population and other chronic diseases. This study concluded to lowest~     HRQL scores in food allergic children compared to type 1 diabetes mellitus with important~     impact on scores concerning social activities.~   "
119113|NCT02008448|"~     The investigators have conducted a prospective, double-blind, randomized study to assess the~     comparative safety and efficacy of two different ablation strategies, PVI plus linear lesions~     (LL) plus botulinum toxin injection versus PVI plus linear lesions (LL), in patients with~     persistent or longstanding persistent AF. Results were assessed with the use of an implanted~     monitoring device (IMD).~   "
119114|NCT02008435|"~     The Diabetes Prevention Program (DPP) is highly effective in promoting weight loss in~     overweight and obese individuals (e.g., 7% average loss of body weight), and thereby reducing~     the risk of developing weight-related health consequences. One-on-one DPP sessions, however,~     are costly and the group-delivered DPP version, the Group Lifestyle Balance program (GLB), is~     less effective (4% average loss of body weight). The aim of this two-arm parallel randomized~     controlled trial is to increase the effectiveness of the GLB by integrating habit formation~     techniques, namely if-then plans and their mental practice, into the program. The study will~     provide evidence-based data on the effectiveness of an enhanced GLB intervention in promoting~     weight loss and in reducing weight-related risk factors for chronic health problems.~   "
119099|NCT02008630|"~     The overall research aim of this study is to investigate changes in measures related to the~     risk of falls among elderly with dementia participating in animal-assisted interventions.~     Also relatives' experience of own and the elderly's situation during and after the~     intervention will be examined. The design will be a prospective and cluster randomized~     multicenter trial, but mixed-methods will be used to target different outcomes. The study~     population will be elderly (age above 65) at day care centers diagnosed with dementia, or~     having a cognitive deficit. The intervention will consist of 30 minutes sessions with~     animal-assisted activity or animal-assisted therapy two times a week for 12 weeks in groups~     of 4-6 participants. Control groups will receive treatment as usual. Research questions:~        1. Is there an effect in use of ordinary and optional medication among elderly persons with~          dementia at day care centers participating in animal-assisted interventions compared to~          a control group?~        2. Is there an effect on social interaction, quality of life, activeness and wellbeing~          among elderly persons with dementia at day care centers participating in animal-assisted~          interventions compared to a control group?~        3. Is there an effect on balance among elderly persons with dementia at day care centers~          participating in animal-assisted therapy compared to animal-assisted activity or a~          control group?~        4. Do relatives of elderly persons with dementia at day care centers experience a change in~          their own and the elderly's situation after the intervention compared with before the~          intervention started?~   "
119100|NCT02008617|"~     Outpatients scheduled to have ACL surgery typically receive a femoral nerve block to provide~     analgesia for the front of the knee. Postoperatively, these patients will often report pain~     in the back of the knee. Local anesthetic infiltration of the posterior aspect of the knee~     results in blockade of the genicular nerves of the posterior knee. These nerves originate off~     of the tibial and common peroneal nerves and their blockade will result in improved posterior~     knee pain relief and may decrease narcotic consumption compared to patients who receive the~     same infiltration with normal saline.~   "
119101|NCT02008604|"~     The aim of the study is to verify the hypothesis that the microbial colonisation of the gut~     is changed in patients after stroke and that the gut microbiome of severely affected stroke~     patients differs from that of patients with only a short disruption of blood circulation in~     the brain (transient ischemic attack, TIA). For this, the composition of gut microbiota in~     stool samples will be analyzed by 454 pyrosequencing. Further, the correlation of~     stroke-associated changes in the microbiome with immunological parameters will be analyzed.~   "
119102|NCT02008591|"~     The primary objective of this study is to compare the onset and duration of the initial dose~     of medications given through three different epidural (conventional epidural, combined spinal~     epidural and dural puncture epidural) techniques for labor pain relief.~      The secondary objective of this study is to compare the fetal effects of these three epidural~     labor analgesia techniques.~   "
119103|NCT02008578|"~     The purpose of this randomized, double-blind, placebo-controlled trial of intravenous~     hyperimmune immunoglobulin (Flu-IVIG) in individuals with influenza A or B is to determine~     the pharmacokinetic (PK) profile of Flu-IVIG and assess whether antibody levels observed~     following Flu-IVIG transfusion are similar to those predicted. This pilot study will inform a~     larger study that will be powered to compare Flu-IVIG with placebo for efficacy.~   "
119104|NCT02008565|"~     The study is a multi-center, randomized, placebo controlled trial with participants~     randomized into one of four groups:~        1. placebo/usual care (educational pamphlet)~        2. loperamide/usual care (educational pamphlet)~        3. placebo/anal exercises with biofeedback~        4. loperamide/anal exercises with biofeedback~      The primary outcome, change from baseline in St. Marks (Vaizey) Score at 24 weeks, will be~     compared between treatment groups using linear regression.~   "
119105|NCT02008552|"~     More than 5 million persons in France exposed, in last years, to the taking of the~     Benfluorex.~      Arisen, at certain patients, of a valvulopathy characterized by mitrals and/or aortic leaks~     Withdrawal of the French market: nov. 2009 Only a percentage limited by exposed patients~     developed a severe valvulopathy (1/1000), whereas on the contrary, many patients were exposed~     during years without developing the slightest anomaly.~      The hypothesis is the existence of a particular genetic susceptibility at the patients having~     developed a valvulopathy continuation in the exposure in this medicine.~      Existence of one varying genetics with strong effect. The purpose is to identify involved~     genetic factors.~   "
119106|NCT02008539|"~     To evaluate the safety and tolerability of MSC_apceth_101.~   "
119107|NCT02008526|"~     Participants receive culturally relevant and specifically tailored text messages based on the~     behavioral change theoretical constructs of Social Support Theory, Health Belief Model, and~     Social Cognitive Theory. Participants are randomized into one of three conditions for an~     8-week intervention period: Group 1: culturally relevant theory-based text messages~     interactively transmitted by peer health educators (TXT-PHE); or, Group 2: the same~     culturally relevant theory-based text messages transmitted by automation (TXT-Auto); or,~     Group 3: assessment-only (AO) control with no theoretically based text messages.~   "
119108|NCT02008513|"~     This is a follow-up study to assess safety and clinical activity of continued AFFITOPE® AD02~     vaccinations in patients with Alzheimer's disease. Patients, who have already participated in~     AFF006 will be involved in 27 study sites in Europe. Duration of patient's participation in~     the clinical trial is 19 months.~   "
119109|NCT02008500|"~     Aim of this study was to assess and compare the efficacy of a commercially available novel~     herbal mouthwash containing potassium nitrate on Dentinal Hypersensitivity (DH) compared to a~     placebo and non herbal potassium nitrate over a period of 12 weeks.~   "
119110|NCT02008487|"~     This study will test a special powder for ulcers caused by a variety of conditions such as~     pressure that sometimes happen when a person is at the end of life. The powder will be~     applied to these ulcers to see if it helps with pain, odor and drainage (leakage). People who~     are being cared for by hospice or palliative care organizations will be invited to be in the~     study. The study will also find out if the powder is easy to use by caregivers as well as~     improving the comfort and quality of life of the person who has the ulcer.~   "
119111|NCT02008474|"~     The purpose of this study is to examine different types of monetary incentive paradigms for~     weight loss.~   "
119115|NCT02008422|"~     The primary objectives of this control, single-center clinical study of EndostarTM Injection~     with/without SOX protocols to treat advanced gastric cancer were to evaluate the clinical~     response rate of Endostar injection concomitant with SOX on patients with advanced gastric~     cancer, observe the progression-free survival time (PFS) of tumor and evaluate the safety and~     tolerance of Endostar injection, while the secondary objectives were to observe the influence~     of Endostar injection on chemotherapy-induced adverse reactions and evaluate the overall~     survival time of EndostarTM injection concomitant with SOX on patients with advanced gastric~     cancer by evaluating the response rate (RR) clinical benefit rate (CBR), progression-free~     survival (PFS) and overall survival (OS).~   "
119116|NCT02008409|"~     The primary goal of the study is to evaluate the safety of the EndoLift Liver Retractor as an~     internal laparoscopic liver retraction device. The secondary goals of the study are to~     evaluate the efficacy of the EndoLift Liver Retractor as an internal laparoscopic liver~     retraction device and to identify 'best practices' for device utilization.~      This study evaluates the use of a specific type of liver retractor (EndoLift). Liver~     retractors are often necessary during MIS procedures, but this retractor is the only device~     which is deployed internally (NOT requiring additional skin punctures/incisions for placement~     of the liver retractor device). All patients undergoing minimally invasive surgery (MIS) at~     Duke Regional Hospital will be approached.~      The new device is expected to have a minimal risk safety profile. The investigators believe~     that these risks are no more than would be encountered by using any other commercially~     available retraction device available on the market today. Data will be collected and~     analyzed by the identified investigators. Continuous variables will be analyzed via T-test~     and Chi-square analysis will be applied to discontinuous variables. Statistical analysis~     software such as SPSS® will be utilized when necessary.~   "
119117|NCT02008396|"~     This randomized, double-blind study is intended to test the safety and feasibility of using~     3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy, compared with placebo, to treat~     social anxiety in autistic adults. Subjects will be randomly (by chance) assigned to receive~     placebo or MDMA during two experimental sessions. The first six subjects in the study will be~     randomized to placebo (2) or 75 mg MDMA on the first session and 100 mg MDMA on the second~     session (4). The next six subjects will be randomized to placebo (2) or 100 mg MDMA on the~     first session and 125 mg MDMA on the second session (4). The study will explore whether two~     doses of MDMA, combined with selected therapeutic activities, can reduce social anxiety. The~     study takes place in Los Angeles, California and requires about 15 visits to the study~     location over several months. Study subjects will meet with the investigators three times to~     prepare for the MDMA sessions, and they will meet with them on three occasions and receive~     daily phone calls for safety monitoring for a week after each session. Blood samples will be~     collected at baseline, two hours after drug administration during the second experimental~     session, one month and six months after the second experimental session to measure amounts of~     the hormones oxytocin, arginine vasopressin and cortisol in plasma. Subjects will return six~     months after their second experimental session for measurements of and social anxiety and~     other symptoms and an interview. Subjects will learn what they received at this visit.~     Subjects who received placebo can go through treatment again to have two sessions with MDMA,~     the first with 75 mg and the second with 125mg MDMA. Social anxiety, anxiety, depression,~     stress, self-esteem, empathy, and quality of life will be measured before and after~     experimental sessions.~   "
119118|NCT02008383|"~     There will be three parts to this phase I study: 1) the Combination Dose Finding cohort; 2)~     the Combination Expansion cohort; and 3) the Monotherapy MET Amplified cohort. In the~     Combination Dose Finding cohort and the Combination Expansion cohort, we will combine~     cabozantinib and panitumumab in patients with KRAS wild-type metastatic colorectal cancer~     (CRC). In the Monotherapy MET Amplified cohort, we will screen at least 50 patients for MET~     gene amplification (MET amplification). Patients with MET amplification will receive~     cabozantinib only (monotherapy).~      The primary objective of this open-label phase Ib trial are:~        1. To determine the maximum tolerated dose and the recommended phase II dose for the~          combination of cabozantinib and panitumumab in patients with KRAS wild-type metastatic~          colorectal cancer and~        2. To identify the objective response rate (ORR) of cabozantinib monotherapy in patients~          with prospectively identified MET amplified metastatic colorectal cancer.~      The secondary objectives are:~        1. To describe the non-dose limiting toxicities of cabozantinib and panitumumab.~        2. To describe the clinical activity (ORR, PFS, OS) of cabozantinib and panitumumab.~        3. To describe the safety and tolerability of cabozantinib monotherapy in patients with MET~          amplified colorectal cancer.~        4. To describe the clinical activity (PFS, OS) of cabozantinib monotherapy in patients with~          MET amplified colorectal cancer.~   "
119119|NCT02008370|"~     The investigators are presently using Exparel, a slow released local anesthestic, in patients~     undergoing minimally invasive cardiac surgery. The primary objective of this study is to~     assess the efficacy of EXPAREL when delivered into the thoracotomy and chest tube sites to~     provide prolonged postoperative analgesia in patients undergoing minimally invasive cardiac~     surgery. Efficacy will be assessed by: the effectiveness of analgesia as measured by the~     subject's overall postoperative pain scores and postsurgical analgesic use.~   "
119120|NCT02008357|"~     The purpose of this study is to test whether an investigational drug called solanezumab can~     slow the progression of memory problems associated with brain amyloid (protein that forms~     plaques in the brains of people with Alzheimer Disease [AD]).~   "
119121|NCT02008344|"~     The purpose of this study is to determine if favipiravir is effective in reducing the time to~     resolution of influenza symptoms.~   "
119122|NCT02008331|"~     The interest on gastrointestinal (GI) dysfunction in CKD has been growing in the last years.~     it is now accepted that GI dysfunction in dialyzed patients may contribute to systemic~     microinflammation by promoting gut dysbiosis and bacterial translocation in the blood.~     Another mechanism by which GI dysfunction contributes to systemic symptoms in CKD is related~     to metabolic activity of the dysbiotic microflora growing in the gut of these patients to~     generate toxic compounds such as phenols, indoles, and amines. Epidemiological evidence has~     strongly linked one of these compounds, p-Cresol, to cardiovascular risk and mortality in~     CKD. In the present paper the investigators investigated the effect of a probiotic/prebiotic~     mixture on plasma p-cresol concentrations and GI symptoms and in CKD patients not on dialysis~     yet.~   "
119123|NCT02008318|"~     The purpose of this study is to investigate the effect of the study drug known as LY2157299~     on red blood cells in participants with myelodysplastic syndromes (MDS). Participants with~     different degrees of disease (very low, low, and intermediate risk) will be studied. The~     study treatment is expected to last about 6 months for each participant.~   "
119124|NCT02008305|"~     Interventional Neuroradiology replaces surgery. This technology requires various exposition~     to X rays : number of X rays photographs, radioscopy, distance between patient and detector,~     speed of acquisition of X-rays photographs, high tension and intensity.~      The manipulator must find the right balance between quality of photographs and dose delivered~     to the patient (optimization).~      Children are particularly exposed to these risks of irradiation (sensitivity to X-rays and~     long life expectancy with risks. So, it is fundamental to optimize the dose delivered during~     the procedures.~      The investigators propose to analyse a study comparing two protocols of optimization of~     doses. The investigators' hypothesis is that the protocol experimented in this trial allows~     less radiation of the children, compared to the usual protocol.~   "
119125|NCT02008292|"~     The purpose of the study is to measure the sensitivity of NCFHEB binding to changes in~     endogenous acetylcholine levels in healthy smoking and nonsmoking subjects, and in~     schizophrenic smoking and nonsmoking subjects. We hypothesize that physostigmine-induced~     elevated ACh levels will lead to a reduction in the availability of nicotinic receptors for~     the binding of the radioligand. We hypothesize there will be greater increase in ACh level~     (or greater reduction in radio tracer binding) in smoking as compared to nonsmoking subjects.~     We hypothesize there will be greater increase in ACh level (or greater reduction in radio~     tracer binding) in smoking as compared to nonsmoking subjects with schizophrenia, but the~     extent of this change will be different than in controls.~      We are also measuring the sensitivity of PHNO binding to changes in dopamine levels in~     healthy smoking and nonsmoking subjects before and after amphetamine challenge.~   "
119126|NCT02008279|"~     The purpose of this study is to find out if different doses of CNTO 3157 are well tolerated~     in both Japanese and Caucasian men as well as to understand how the body absorbs and removes~     the study drug after being injected or infused into the body.~   "
119127|NCT02008266|"~     This non-interventional, descriptive, cross-sectional and multicenter study will examine the~     treatment of rheumatoid arthritis progressing for less than two years in the Algerian~     population. Current drug therapy as well as disease status and patient function will be~     assessed.~   "
119128|NCT02008253|"~     To evaluate the clinical outcomes of intrastromal corneal ring segment (ICRS) implantation to~     correct keratoconus on eyes with prior refractive surgery.~   "
119129|NCT02008240|"~     The aim of this randomized controlled trial is to compare the efficacy of ultrasound guided~     aspiration of hydrosalpingeal fluid with salpingectomy in the management patients with~     ultrasound visible hydrosalpinges undergoing IVF-ET.~   "
119130|NCT02008227|"~     This global, multicenter, open-label, randomized, controlled study will evaluate the efficacy~     and safety of atezolizumab (an anti-programmed death−ligand 1 [anti-PD-L1] antibody)compared~     with docetaxel in participants with locally advanced or metastatic non-small cell lung cancer~     (NSCLC) after failure with platinum-containing chemotherapy. Participants will be randomized~     1:1 to receive either docetaxel or atezolizumab. Treatment may continue as long as~     participants are experiencing clinical benefit as assessed by the investigator, i.e., in the~     absence of unacceptable toxicity or symptomatic deterioration attributed to disease~     progression.~   "
119131|NCT02008214|"~     Current Hepatitis C virus (HCV) treatment consists of the combination of interferon alpha 2a~     (IFN-alpha 2a) plus ribavirin (RBV) and it provides sustained virologic responses (SVR) on 54~     to 56% on HCV monoinfected patients and this response is even lower on HIV-HCV coinfected~     patients. A previous study on HCV monoinfected patients showed that the addition of~     pentoxyfylline (PTX) to a treatment scheme based on interferon-alfa and ribavirin increased~     SVR on 25%, although it is not known if the same effect is to be obtained in HCV-HIV~     coinfected patients.~      On the other hand, other factors such as host genetics, have proved to influence treatment~     response on HCV infected patients. The best described genetic factor so far is the~     interleukin 28B (IL28B) polymorphism rs12979860, where a cytosine-cytosine (CC) genotype~     provides an almost twice increase on SVR than the rest of the genotypes.~      Therefore, this is a randomized, double blind study to assess the efficacy of pentoxyfylline~     addition to a treatment scheme based on interferon-alfa and ribavirin in chronic HCV genotype~     1, co-infected HIV-1 positive subjects, considering the IL28B polymorphism rs12979860.~      HIV-HCV coinfected subjects currently receiving Highly active antiretroviral therapy (HAART),~     with at least 8 months on undetectable HIV viral load and T helper cells count of 200 or~     higher will be included. Patients will be randomized on one of two groups:~        -  Group A: IFN alpha 2a + RBV + PTX~        -  Group B: IFN alpha 2a + RBV + placebo~      Patients will be followed for primary outcome during 72 (for rapid responders) or 96 weeks~     (for non rapid responses). Outcome measures will be the following:~        -  SVR rate 24 weeks after the end of treatment~        -  Grade of Hepatic fibrosis from baseline to the end of treatment, measured by transient~          elastography and the AST to platelet ratio index (APRI index)~        -  IL28B rs12979860 genotype~      The study hypothesis is that the addition of PTX to a treatment scheme based on IFN-alfa2a~     and RBV in chronic HCV genotype 1, co-infected HIV-1 positive subjects will improve SVR rate~     and fibrosis progression irrespectively of IL28B rs12979860 genotype.~   "
119132|NCT02008201|"~     The objectives of this study are 1) to assess the prevalence of vitamin D deficiency in a~     group of sub elite athletes and 2) to identify seasonal changes in vitamin D status and the~     effect that supplementation may have during the course of a year.~      The study is a double blinded parallel study design.~   "
119133|NCT02008188|"~     The purpose of this study is to use an Advisory/Automated Adaptive (AAA) Control system for~     insulin delivery in adults with Type 1 Diabetes (T1DM) in an outpatient setting to evaluate~     the system's ability to significantly improve blood glucose levels. This protocol represents~     a culmination of prior clinical trials in development of this AAA control system and benefits~     from the synthesis of those components.~   "
119134|NCT02008175|"~     Keratoconus is a chronic progressive non - inflammatory disorder characterised by progressive~     steepening and thinning of cornea and high myopic astigmatism, accounting for poor visual~     acuity in such individuals. Keratoconus seems to be more advanced on presentation, in young~     patients.~      The investigators intend to evaluate the effectiveness of conventional collagen cross linking~     in young patients diagnosed with keratoconus.~   "
119135|NCT02008162|"~     To assess response to bronchodilation with tiotropium plus salbutamol in patients with severe~     emphysema and analyze relationships between bronchoreversibility response and~     semiquantitative computed-tomography based emphysema severity measures.~   "
119147|NCT02008006|"~     The purpose of this study is to evaluate the efficacy and safety of BeEAM (bendamustine,~     etoposide, cytarabine and melphalan) regimen prior to autologous stem cell transplant for~     first and second chemosensitive relapses in patients with follicular lymphoma (World Health~     Organisation (WHO) grade 1, 2, 3a).~   "
119136|NCT02008149|"~     Following a complete spinal cord injury (SCI), individuals experience progressive bone loss,~     especially in the legs, with up to 70% of persons with SCI sustaining a fracture at some~     point during their lifetime. Fractures following SCI are costly to treat and more than half~     of patients experience a medical complication, requiring extended hospitalization, resulting~     in a substantial impact on their quality of life. To reduce the incidence of fractures, more~     effective rehabilitation strategies to prevent bone loss are needed. The goal of this~     research is to determine if bone health can be preserved using an indoor rowing exercise~     program in which the leg muscles are electrically stimulated using several, small surface~     electrode pads that are placed on the skin on the front and back thigh muscles. An~     encouraging case study has recently shown remarkable bone preservation in one individual with~     SCI who participated in an electrical stimulation rowing program, however, whether other~     individuals with SCI can achieve the same benefit is currently unknown.~   "
119137|NCT02008136|"~     This protocol is a prospective, open label, pilot study examining the utility of three~     established pain questionnaires (the Visual Analogue Scale (VAS), Neck Disability Index~     (NDI), the Oswestry Low Back Pain Questionnaire and two novel pain scale devised by the PI)~     as well as their relationship to three novel quantitative tools to measure the effect of~     botulinum toxin injections for neck pain and back pain. The three novel methods for measuring~     neurotoxin effect are: muscle twitch patterns using surface electromyography (sEMG), cervical~     and lumbar range of motion using a neck and low back inclinometer, and skin surface~     temperature readings using an infrared imaging camera.~   "
119138|NCT02008123|"~     The purpose of this study is to determine whether adding primidone will improve the~     metabolism of clopidogrel thereby increasing metabolite levels within the blood stream and~     platelet response to clopidogrel in patients who were previously found to lack adequate~     response to clopidogrel. This information could help overcome clopidogrel resistance in~     patients who are at risk for stroke or transient ischemic attack (TIA).~   "
119139|NCT02008110|"~     Preliminary data suggest a potential role for monitoring and up-titrate pharmacological~     therapy of plasma levels of antigen carbohydrate 125 (CA125) following and admission for~     acute heart failure (AHF).~      This study will evaluate the effect of a CA125-guided management strategy versus standard~     therapy on the composite endpoint of 1-year all-cause mortality or readmission for AHF in~     patients recently discharged for AHF.~   "
119140|NCT02008097|"~     The goals of this study are to evaluate the efficacy of the B-flow capability on the LOGIQ E9~     system in three clinical focus areas.~        1. Liver transplant patients: Improved real-time visualization of liver vessels is needed~          to improve diagnosis and assessment following stenting or angioplasty.~        2. Renal artery disease: Improved real-time visualization of the renal arteries would~          enable a more rapid and accurate assessment of renal artery disease (stenosis,~          dissection, occlusion, aneurysm) and facilitate follow-up evaluations after renal artery~          interventions.~        3. Pregnancy: We are proposing to use B-flow ultrasound as a way to evaluate placenta~          perfusion and assay for potential ischemia.~   "
119141|NCT02008084|"~     The purpose of this pilot study is to learn what study factors are important in designing a~     large, full-scale study of the effects of TRIA-662 on serum triglycerides (TG) and~     high-density lipoprotein cholesterol (HDL-C) levels. In this study, patients will first enter~     a Single-blind, dietary-controlled baseline period and receive 1000 mg placebo or active drug~     three times daily with meals (i.e., breakfast, lunch, and dinner) for 6 - 8 weeks. If the~     qualify to continue, they will then receive up to 2000 mg of active or placebo drug for an~     additional 14 weeks. Active drug will be given to 48 patients and placebo drug will be given~     to 16 patients. However, neither the patients not the clinic staff will know which patients~     are on active or placebo drug until the end of the study.~   "
119142|NCT02008071|"~     The purpose of this study is to conduct a pilot randomized controlled trial, to determine~     whether providing financial incentives for meeting daily step goals (a) increases the daily~     step counts of participants, (b) increases compliance with the overall program (including~     diet recommendations), and (c) increases weight loss.~   "
119143|NCT02008058|"~     This is a single-arm observational longitudinal study in of patients with metastatic~     castrate-resistant prostate cancer designed to assess the longitudinal trajectory of pain and~     other symptoms.~   "
119144|NCT02008045|"~     The purpose of this study is to collect and compare information from cranial ultrasounds,~     magnetic resonance imaging scans, neurological exam and neuropsychological assessments of~     children. The investigators hope that the information collected in this study will help with~     early screening, diagnosis and treatment of brain injury in newborns as well as identify a~     connection between MR imaging (MRI-magnetic resonance imaging, MRS-magnetic resonance~     spectroscopy) and neurodevelopmental outcome.~   "
119145|NCT02008032|"~     Purpose:The aim of this research is to compare the 3D s-DBT (stationary digital breast~     tomosynthesis) and conventional 2-D digital mammography devices with regards to patient~     comfort and radiologist preference in women with breast implants.~      Participants: Women with breast implants undergoing routine 2-D digital mammography.~      Procedures (methods): 50 female subjects with breast implants undergoing conventional~     screening mammography will be recruited to have a single view s-DBT in the mediolateral~     projection. We will perform a patient preference study and radiologist reader study composed~     of radiologists who have experience evaluating tomosynthesis images. A short survey will be~     given to each patient about their preference in modality with respect to comfort. Each reader~     will review the images and score the ease of interpretation, and their confidence of~     interpretation.~   "
119146|NCT02008019|"~     The mainstay of chondrosarcoma treatment is a wide surgical resection. Unfortunately, this is~     a rare occurrence, and patients with incomplete resection have very poor therapeutic options.~     In this context, it becomes important to find new therapeutic strategies to slow down tumor~     progression and to reduce tumor size before resection.~      Pre-clinical and clinical data suggest that EVEROLIMUS should be efficient as adjuvant and~     neo-adjuvant therapy in chondrosarcoma.~      Then, investigators propose a phase II, randomized, open label study compounded by 3 arms~     (1:1:1) to assess efficiency of EVEROLIMUS as neo-adjuvant therapy in patients with primary~     or relapsed chondrosarcomas :~      ARM 1 = No treatment; ARM 2 = 2,5 mg Everolimus/day; ARM 3 = 10 mg Everolimus/day.~      The treatments will be taken for 4 weeks before surgery, apart from any premature withdrawn~   "
119148|NCT02007993|"~     The aim of the proposed controlled clinical trial is to evaluate the effect of photodynamic~     therapy (PDT) on the formation of volatile sulfur compounds (VSCs) from coated tongue and its~     action on the severity of halitosis in adolescents using different treatment protocols.~      HYPOTHESIS~        1. - Null hypothesis: There is no change in halitosis following the use of photodynamic~          therapy.~        2. - Experimental hypothesis: There is a reduction in halitosis following the use of~          photodynamic therapy alone or in combination with a tongue scraper.~   "
119149|NCT02007980|"~     The aim of this study is to identify the root cause for the significant discolouration of~     Boston Scientific Percuflex based stents.~   "
119150|NCT02007967|"~     The overall objective of this proposal is to examine the feasibility and accuracy of~     non-contrast magnetic resonance angiography (MRA) to comprehensively evaluate individuals~     referred for transcatheter aortic valve implantation (TAVI).~   "
119151|NCT02007954|"~     The purpose of this study is to determine the feasibility and safety of using small beads~     (70-150 micron in place of 100-300 micron) to deliver chemotherapy into the liver to treat~     patients with hepatocellular carcinoma (HCC). The beads (LC-Bead M1) will be loaded with~     doxorubicin (DEBDOX-M1), and used to administer transarterial chemoembolization (TACE)~     DEBDOX, loaded with doxorubicin, is a device that utilizes tiny beads (70-150 microns) to~     deliver chemotherapy agents into liver tumor(s) via the hepatic artery. This device allows~     for continuous release of doxorubicin into the liver tumor tissue(s) causing necrosis of the~     targeted tumor(s). The potential advantages of the smaller beads are deeper penetration into~     the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and~     more consistent dosing. Response to therapy will be evaluated monthly by clinic visits and~     blood tests (to include assessment of liver function and tumor markers) and by imaging~     (usually MRIs) every 1-2 months. Patients will be on study for 6 months after which they will~     be exited from the study and followed for survival. Once exited from the study they will~     continue to be eligible to receive the smaller beads (DEBDOX), should it be recommended.~   "
119152|NCT02007941|"~     The purpose of this study is to assess between the renal impaired patients and normal renal~     function subjects comparetive evaluation to Pharmacokinetics after CKD-501 Future, When~     prescription CKD-501 to renal impaired patient, It will be guidelines to provide a basis of~     instructions.~   "
119153|NCT02007928|"~     We propose a prospective multicenter study, whose originality lies in the inclusion of the~     naive child and adolescent population. Its purpose is to evaluate the incidence of adverse~     events related to the use of l antipsychotic drugs in children and adolescents with no~     history of taking such drugs.~      The inclusion criteria will be: (1) male or female inpatients, (2) aged from 6 to 18 years,~     (3) requiring antipsychotic treatment, (4) receiving antipsychotic drug for less than 28 days~     without taking antipsychotic before or with a history of antipsychotic over a maximum period~     of three consecutive months and discontinued for at least 6 months.~      Therapeutic monitoring during the 12 month study period will include clinical assessments and~     laboratory testing. These assessments will be performed before treatment (at inclusion), and~     at 1, 3, 6, 9, 12 months after the introduction of the antipsychotic drug.~   "
119154|NCT02007915|"~     To determine the safety and effectiveness of pamidronate in patients with radiographically~     proven avascular necrosis which are the result of unstable (acute) slipped capital femoral~     epiphysis, traumatic proximal femur fractures, traumatic hip dislocations, or idiopathic in~     nature.~   "
119155|NCT02007902|"~     The primary aim of this study is to investigate the relationship between early plasma protein~     levels and hemodynamics in very preterm infants during postnatal transition. Secondary aims~     are the following: i) to evaluate maternal and neonatal factors affecting plasma protein~     level at birth; ii) to evaluate the relationship between plasma protein level and albumin~     level on the first day of life; iii) to evaluate the association between early~     hypoproteinemia and neonatal mortality and morbidity in very preterm infants.~   "
119156|NCT02007889|"~     Risk factors for parenchymal damage in urinary tract infection are vesicoureteral reflux~     (VUR),obstructive uropathy,the number of flares of acute pyelonephritis(APN) and delay in~     treatment of acute infection.The pathogenesis of APN is related to bacterial~     virulenece,immune response,tissue factors,apoptosis and production of free radicals that lead~     to fibrosis and renal scarring. Oxidative stress in renal cells may be a critical factor in~     the pathogenesis of pyelonephritis whereas pharmacological management of the oxidative stress~     response may provide a therapeutic effect in preventing renal pathologies. Animal model show~     that L-carnitine alleviated oxidative stress, and acute renal inflammatory injury can be~     prevented much more effectively by carnitine in addition to conventional antibiotic treatment~     in pyelonephritis.This study is a simple randomized clinical trial (RCT) evaluating the~     effect of L-carnitine in addition to antibiotic on preventing renal scaring after acute~     pyelonephritis in children. Simple non- blind randomized clinical trial on 78 patients in 2~     groups (intervention & control) is conducted.Children aged 1 month to 10 years with positive~     urine culture, clinical findings, and 99mTc-dimercaptosuccinic acid (DMSA) scintigraphy-based~     evidence in favor of acute pyelonephritis were enrolled into a clinical trial. Patients were~     excluded if they had neurogenic bladder, systemic hypertension, obstructive uropathy.~     Patients in Intervention group are administered 50 mg/kg/day carnitine in divided 2-3~     times/day (maximum 3 g/day) in addition to antibiotic regimens and patients in control group~     received antibiotic regimens. Primary outcome is the development of renal scar by doing DMSA~     renal scan on the 7th day of admission and six months after the intervention and compared~     between groups and secondary outcome is the incidence and severity of pyelonephritis and~     response to treatment.~   "
119157|NCT02007876|"~     In this pilot study a group of older adults undergoing midline laparotomy for~     gastrointestinal malignancy will participate in a mobility and activity training (MAT)~     program. MAT is designed to advance functional mobility and physical activity and spans the~     pre-operative, inpatient, and post-operative period. Patients undergoing abdominal surgery~     will be randomized to MAT versus control usual care and evaluated at their first appointment~     4 weeks preoperatively (baseline), immediately prior to surgery, on hospital discharge, and 6~     weeks post operatively. We hope to prove that abdominal surgery patients undergoing MAT will~     show less decline and earlier recovery in functional activity, and trunk and thigh muscle~     strength mass. This study is uniquely innovative in that it links functional activity~     assessment and training and analysis of trunk morphomics (muscle mass) in exploring~     mechanisms of post-operative recovery. Results from this pilot will be used to determine an~     effect size for the recruitment of a larger cohort and to study key surgical outcomes,~     including surgical complications, operative symptoms, hospital length of stay, and cost of~     care.~   "
119334|NCT02005549|"~     This study will evaluate the effect of Avastin (15mg/kg iv) in combination with Docetaxel and~     Xeloda, given as pre-operative therapy to patients with primary breast cancer. Avastin will~     be administered every 3 weeks, for the first 5 cycles of chemotherapy. The anticipated time~     on study treatment is 3-12 months.~   "
119158|NCT02007863|"~     Unrelated Cord Blood (UCB) transplant in children is a viable stem cell transplant modality~     for patients with leukemia and myelodysplasia. UCB is now considered Standard Of Care in~     cases where a suitable living bone marrow donor is not available. The survival of UCB is~     similar to Matched Unrelated Marrow Transplant. This study is considered Research since UCB~     is not a licensed product and requires investigational new drug (IND). THERE ARE NO SPECIFIC~     RESEARCH QUESTIONS IN THIS PROTOCOL. This protocol merely provides UCB as a stem cell~     treatment modality to pediatric patients who may require it after a conditioning regimen that~     excludes Total Body Irradiation.~   "
119159|NCT02007850|"~     Quadriceps muscle strength is an important determinant of quality of recovery in elderly~     patients after total knee arthroplasty. We try to compare the quadriceps muscle strength~     change between 0.2 % ropivacaine continuous fixed femoral infusion and patient controlled~     femoral analgesia group.~   "
119160|NCT02007837|"~     Hypertensive disorders of pregnancy (HDP) are with 50.000 deaths every year one of the major~     causes of maternal mortality worldwide, especially in low and middle income countries. This~     trial aims to determine whether a daily dose of combined low-dose aspirin, calcium, vitamin~     D3, folic acid and vitamin B12 in pregnancy reduces the incidence of pregnancy-induced~     hypertension in women at risk. Secondary and tertiary objectives include other maternal and~     neonatal outcomes.~   "
119161|NCT02007824|"~     Study objective The purpose of this trial is to evaluate the efficacy and safety of the~     investigational device, ULSD-12D, as Compared to the comparator, SONOCA-180, in chronic~     wound.~   "
119162|NCT02007811|"~     The reconstitution of a functioning immune system after allogeneic stem cell transplantation~     takes months to years. Particularly memory B-lymphocytes reconstitute poorly with the current~     conditioning regimes. During the period of intense immune suppression the patients are~     extremely susceptible to bacterial, fungal and, most importantly, viral infections.The~     adoptive transfer of B-lymphocytes from the stem-cell donor might significantly enhance~     humoral immunity for the patient. Aim of the study is to evaluate a new cellular therapy with~     B-lymphocytes regarding safety. A booster vaccination after B-lymphocyte transfer will~     evaluate the functionality of the transferred B-lymphocytes in the patient.~   "
119163|NCT02007798|"~     An excellent recovery profile is critical for neurosurgical anesthesia. Rapid awakening,~     smooth blood pressure and heart rate (HR), a higher degree of coordination, painless or mild~     pain, as well as better tolerance to endotracheal intubation can avoid can increased~     intracranial pressure, elevated blood pressure and rapid HR caused by emergency choking,~     suffocation and agitation, and can reduce postoperative cerebral edema and the risk of~     bleeding. In addition, it is easy for surgeons to timely evaluate postoperative patients'~     neurologic function based on the excellent recovery from anesthesia. Up to now, there are~     many methods and drugs to improve the quality of recovery period, but each of them has some~     flaws. Dexmedetomidine, an emerging anesthetic adjuvant, exhibits a stable hemodynamic~     recovery period, and cannot affect evaluation of neurological function with both the sedative~     and analgesic effects. We propose the following hypotheses: (1) A small dose of~     dexmedetomidine can be intravenously injected into patients subjected to craniotomy under~     general anesthesia, in order to improve the recovery profiles and reduce the incidence of~     emergence agitation. (2) Dexmedetomidine can reduce postoperative pain.~   "
119164|NCT02007785|"~     The purpose of the study will be to determine the effects of the Cognitive Orientation to~     daily Occupational Performance (CO-OP) as a treatment program for individuals with~     Parkinson's disease-related cognitive impairment. The potential effects of the CO-OP on~     successful engagement in meaningful activities will be examined from participants' and~     live-in caregivers' perspectives. Effects of the CO-OP on participant-perceived~     health-related quality of life and caregiver burden will also be evaluated.~      Hypotheses:~        1. Training with the CO-OP will have an effect or multiple effects on participation in~          meaningful activities and health-related quality of life for individuals with~          Parkinson's-related cognitive impairment.~        2. Training with the CO-OP will have an effect or multiple effects on caregiver burden and~          health-related quality of life for caregivers of individuals with Parkinson's-related~          cognitive impairment.~   "
119165|NCT02007772|"~     The purpose of this trial ist to investigate the difference of the efficacy of two systems~     for breath support in patients with COPD.~   "
119166|NCT02007759|"~     The purpose of this study is to evaluate if the use of Neuromuscular Electrical Stimulation~     (NMES) will provide a more efficient method of treating neonates with dysfunctional oral~     feeding such as dysphagia. This study will attempt to determine if NMES applied to neonates~     at 36-42 weeks post-conception age (PCA) will decrease the need for nasogastric tubes (NG)~     and gastrostomy tubes (G-TUBE). Increase the rate at which these neonates complete full oral~     feeds, improve their swallowing skills, increase oral intake of calories, and gain weight.~   "
119167|NCT02007746|"~     Patients with sickle cell disease many have a number of systemic complications, including~     liver problems. Some of these liver problems lead to liver fibrosis/cirrhosis, secondary to~     chronic blood transfusions. The purpose of this study is to investigate FibroScan readings in~     patients with sickle cell disease and iron overload secondary to blood transfusions, and to~     correlate the FibroScan results with Ferriscan. A comparison with the results of FibroScan to~     patients with Sickle cell without known liver disease, who have never been on chronic~     transfusions and with normal liver function profiles will also be made.The primary hypothesis~     is that the results of FibroScan will correlate with the results of Ferriscan and liver~     biopsy.~   "
119183|NCT02007538|"~     In the diagnosis of lung cancer, the cytological sample obtained during Bronchoscopy (FBS),~     has an increasingly important role in the characterization of malignancy. The cytological~     sample can be harvested during bronchoscopy by bronchial brushing, bronchial lavages or fine~     needle aspiration. Immunocytochemical staining allows not only to discriminate between small~     cell lung cancer versus non-small cell lung cancer (NSCLC), but also to identify the~     expression of specific markers such as TTF-1, CK7, CK20, 4A4, 34βE12 and p63. Thin Prep is a~     technique for cytological assay already validated and largely used in the immunocytochemical~     determination of gynaecologic specimens. Further Studies are required to asses the accuracy~     of this technique compared to conventional smear in cytological airway samples obtained by~     fine needle aspiration.~   "
119168|NCT02007733|"~     Diarrhea is the second leading cause of death in children worldwide, and accurately assessing~     dehydration status remains a crucial step in preventing morbidity and mortality from this~     disease. While children with severe dehydration require immediate treatment with intravenous~     fluids, children with mild to moderate dehydration have a significant reduction in hospital~     length of stay and fewer adverse events when treated with relatively inexpensive oral~     rehydration solution (ORS). While several clinical scales have been developed for assessing~     dehydration in children, these scales have never been prospectively validated in a low-income~     country setting, where the vast majority of diarrhea morbidity and mortality occurs in~     children.~      The investigators hypothesize that new clinical and ultrasound-based tools will improve the~     diagnosis of severe dehydration in children with diarrhea in low-income countries, reducing~     the morbidity and mortality that occurs as a result of under-diagnosis of severe dehydration~     as well as the adverse events and inappropriate utilization of scarce resources that occurs~     as a result of over-diagnosis of severe dehydration.~   "
119169|NCT02007720|"~     The purpose of the study is to evaluate the efficacy, safety and tolerability of intravenous~     infusion of serelaxin, when added to standard therapy, in acute heart failure (AHF) patients.~   "
119170|NCT02007707|"~     The goals of the study are to develop smoking cessation intervention using lay health worker~     (LHW) outreach and family involvement targeting Vietnamese Americans ages 18 and above in~     Santa Clara County, CA, to evaluate efficacy of the proposed intervention. The study is a~     two-arm randomized controlled trial targeting a total of 18 lay health workers (LHW) and 108~     dyads of a smoker and a family member from the same household. The hypotheses are:~      H. At 6-month post initiation of the intervention, Vietnamese male daily smokers who receive~     the proposed ―Quit Smoking For a Healthy Family Intervention, a Family-based Intervention~     (FI), will be more likely to achieve biochemically verified 7-day point prevalence of smoking~     abstinence when compared to those receiving an attention control intervention (CI).~      H2. At 6-month, FI participants we be more likely to report making at least one 24-hour quit~     attempt than those in CI.~      H3. At 6-month, FI participants will be more likely to report using a recommended~     evidence-based smoking cessation resource (quitline, FDA-approved smoking cessation~     medications, advice from health professionals) than those in CI~   "
119171|NCT02007694|"~     Recent advances in animal research have identified pharmacological agents that appear to both~     accelerate and consolidate extinction learning. One cognitive enhancers is Yohimbine~     hydrochloride (YOH). A finding in animal literature is that the administration of YOH during~     extinction trials accelerates fear reduction and may convert ineffective exposures in to~     successful ones. It is thought that the mechanism of enhanced emotional memory is through~     elevated norepinephrine. However, recent findings demonstrate mixed results. In a randomized~     controlled trial claustrophobic participants underwent exposure in combination with YOH or~     placebo. The YOH group showed significantly better results on anxiety improvement than the~     placebo group. In a more recent study with participants with fear of flying no additional~     benefits of YOH were demonstrated. Therefore, we intend to replicate and extend these studies~     by enhancing the dose of YOH in combination with VRET and by extending our experimental~     design with another group which receives propranolol in combination with VRET. Propranolol is~     β-adrenergic receptor antagonist, which has proven to disrupt reconsolidation in healthy~     humans. In this randomized controlled trial a between groups design is chosen to further~     characterize the differential within and between trial extinction and to enhance possible~     between groups effects. Sixty participants with fear of flying or fear of heights will be~     randomly assigned to one of the following three conditions 1) VRET plus YOH, 2) VRET plus~     Propranolol, or 3) VRET plus placebo. Participants in all conditions will be offered three~     sessions of VRET over a period of two weeks.~   "
119172|NCT02007681|"~     The main purposes of this randomized cross-over trial are to test if a 3h/day reduction of~     time spent in sedentary behaviour (SB) through breaking up hourly and shifting it for~     standing and walking behaviours would substantially increase total (TEE) and PA energy~     expenditure (PAEE) compared to a week of habitual prolonged SB, in male and female~     overweight/obese inactive (which do not attained MVPA recommendations) and sedentary desk~     workers. Specifically using an experiment design our main aims are: a) to determine the~     impact of reducing SB on TEE and PAEE; b) to analyse the independent effects of interrupting~     SB through breaks and the overall reduction in SB on TEE and PAEE; c) To analyse the~     determinants for the overall reduction in SB; d) If the changes occurred in TEE and PAEE were~     dependent on specific covariates.~   "
119173|NCT02007668|"~     Sixty patients will be randomized into three groups to receive the Kinesio taping, placebo~     Kinesio taping (medical adhesive tape) and control group. The group Kinesio taping receive~     the correct application of the method described. The placebo group will receive a medical~     adhesive tape. The control group will not receive any form of intervention.~   "
119174|NCT02007655|"~     The primary objectives of this study are:~        -  To estimate the incidence rate of unexpected adverse events~        -  To characterize the bleeding events and assess risk factors of bleeding~        -  To identify ancillary baseline variables that may also be associated with adverse~          outcomes~   "
119175|NCT02007642|"~     The study patients are patients suffering from primary or secondary immunodeficiencies~     investigated in the Hospital Necker for a suspected infectious disease.~      The study purpose is to assess the performance of a High Throughput Sequencing method, the~     PATHOQUEST method (from sample preparation to bio informatic analysis), versus the classic~     diagnostic approach.~      The study will evaluate the capacity of the PATHOQUEST method to detect pathogens responsible~     for an infectious disease episode and will also evaluate the delay of obtention of results~     compared to the classic diagnostic approach.~   "
119208|NCT02007200|"~     This phase II clinical trial studies how well soy isoflavones work in preventing head and~     neck cancer in patients with stage I-IV head and neck cancer undergoing surgery.~     Chemoprevention is the use of certain drugs to keep cancer from forming. The use of soy~     isoflavones may prevent head and neck cancer recurrence.~   "
119209|NCT02007187|"~     The purpose of this study is to determine the efficacy and safety of Danhong injection in the~     treatment of unstable angina pectoris.~   "
119388|NCT02004847|"~     The purpose of this study is to determine the efficacy and safety of a blue light device for~     treating Psoriasis vulgaris. The study will compare a blue light treated plaque with an~     untreated control plaque. Additionally, two intensities of blue light are compared.~   "
119389|NCT02004834|"~     The purpose and the goal of this paper is to show whether the application of a combination of~     two local anesthetics, as opposed to the application of one local anesthetic at paravertebral~     block changes the hemodynamic variable. It is therefore a prospective randomized double-~     blind study, where we do a clinical trial in patients ASA(American Society of~     Anesthesiologists) 1 and 2 statuses between 18 and 80 years of age, using the ultrasound in~     plane technology.Upon arrival of patients in the unit for preparation procedures for~     anesthesia we set the ECG(electrocardiograph), noninvasive blood pressure, oxygen saturation,~     and arterial cannula in the radial artery After sterile washing of the dorsal surface,~     paravertebral space was identified with ultrasound using 8 Hz(hertz) linear transducer probe~     then needle position was confirmed with neurostimulation at the level of 2.0 - 5.0~     mA(milliampere). When muscle contraction persisted at 0.4mA(milliampere), the anesthetic was~     applied in levels of Th 2, Th3, and Th 4 (7,0 milliliters per level). We applied the 0.5 %~     levobupivacaine and 2 % lidocaine, 7,0 milliliters of mixture per level in one group, while~     only 0.5 % levobupivacaine also 7,0 milliliters. by level in the second one. After that, the~     invasive hemodynamic monitoring was placed on patients and the induction with 1 % propofol~     2-2.5 mg/kg.and Vecuronium 0,08 mg/kg. was performed with the application of supraglottic~     airway gel of appropriate size. The maintenance of anesthesia and sedation will be conducted~     with Propofol 1 % continuously ( 25-150 mcg / kg / min.)The measurements will be taken every~     5 minutes during the first hour of the application of paravertebral block, then every 15~     minutes during the second hour and if the operation takes more than two hours, the~     measurements are performed every 30 minutes. Postoperatively, invasive hemodynamic monitoring~     will be removed in post-anesthesia recovery room together with the arterial cannula and the~     patient will be sent to the hospital ward with non-invasive hemodynamic monitoring (blood~     pressure, pulse, saturation) until the termination of the blocks.Statistical methods, By~     comparing two target groups, we analysed the strength of the test with following assumptions:~     X2 difference test, the expected difference in variances in stroke volume between groups of~     60%, α significance level of 0.05, and the minimum statistical test strength of 85%. The~     required total sample should include at least 80 patients, that is, 40 per group.Data will be~     presented in tables and graphs. Descriptive statistics of examined variables with appropriate~     measures of central tendency will be made. Smirnov -Kolmogorov test will assess the normality~     of data distribution. According to the received results, the appropriate parametric and / or~     nonparametric tests will be used. Comparisons of quantitative values between the two groups~     will be analyzed using the independent t-test or Mann-Whitney U test. Dependent values within~     each group will be analyzed using analysis of variance for repeated measures or Friedman~     test. Differences in categorical values will be analyzed by X2 test. The appropriate~     regression model will be made in order to predict the variability of stroke volume in which~     the dependent variable will be a variation of the stroke volume, while relevant clinical~     values will be taken as predictor variables. All P values smaller than 0.05 will be~     considered significant.~      This research is to present the main results - the existence of the significant change in~     Stroke Volume Variation (SVV) between groups using invasive hemodynamic monitoring, the~     changes of Stroke Volume Variation(SVV) depending on the time from the application within~     groups, differences in volume compensation of crystalloids and colloids and the need for the~     application of vasoactive drugs. Furthermore, as a secondary results we will present the time~     to maximal block development, the duration of post operative analgesia, patient satisfaction~     and time needed for the full recovery from the block.~   "
119176|NCT02007629|"~     BAY63-2521 Riociguat leads to the relaxation of smooth muscle cells in pulmonary arteria and~     may also inhibit abnormal remodeling of lung blood vessels. In patients with pulmonary~     arterial hypertension Riociguat showed to reduce the pulmonary blood pressure and improved~     the right heart function without unacceptable side effects. Here dose of Riociguat will be~     adjusted over 8 weeks then a Maintenance Phase of 16 weeks follows. Patients with Pulmonary~     Arterial Hypertension treated with stable doses of Phosphodiesterase Type-5 Inhibitors (Eg~     Sildenafil, Tadalafil) not appropriately responding to therapy will be included. Based on~     previous evidence and on the different modes of action an improvement of exercise capacity,~     heart function and quality of life may be expected if PDE5i treatment is transitioned to~     riociguat.~      Where Riociguat is pending market approval or reimbursement once the treatment phase is~     completed drug can be made available for another 18 months (Extended Drug Supply Phase -~     EDSP) under study conditions. Patients may also transition at the end of the maintenance~     period or any time during the EDSP to any program that is intended to provide riociguat until~     drug approval/reimbursement, e.g. a long-term extension study, compassionate use or named~     patient program. Study termination is also possible at any time.~   "
119177|NCT02007616|"~     The ageing of the population will inevitably lead to a growing number of older people living~     alone and in need of care. Given the high cost of geriatric care, a critical research issue~     is exploring ways to improve or maintain cognitive and functional status in old age.~     Unfortunately, it has been shown that training those specific cognitive processes most~     sensitive to ageing (such as speed of processing or working memory), produces only limited~     beneficial effects. However, research also suggests that factors such as cognitive~     engagement, physical activity and social context may act as more general modulators of~     cognitive decline. This project is a longitudinal study with experimental and control groups.~     It is inspired from the engagement model of cognitive optimization suggesting that a~     lifestyle marked by social and intellectual engagement may mitigate age-related declines on~     cognitive functioning. It uses new cutting-edge information computing technology (ICT)~     solutions to improve or simply maintain cognitive functions in the elderly. This research~     investigates how the treatment reduces the effects of cognitive age-related decline in~     executive control processes and episodic (explicit) memory using behavioral and imaging~     measures. The results will provide significant knowledge on the potential of new ICT~     technologies to delay, compensate, and even prevent common chronic problems experienced by~     the elderly population. The hypothesis is that cognitive training with video-games through~     ICT solutions will promote brain and mental health and independence. Ultimately, the~     objective is to contribute to the understanding of factors that help avoiding the (personal~     and economic) consequences of long-term care in geriatric institutions.~   "
119178|NCT02007603|"~     The study will be conducted to investigate the pharmacokinetics of ampicillin / sulbactam and~     amoxicillin/clavulanic acid during intermittent haemodialysis.~   "
119179|NCT02007590|"~     To investigate whether high frequency airflow oscillation (HFAO), delivered using Aerosure,~     increases six minute walk distance (6MWD) and reduces exertional breathlessness in patients~     with severe chronic obstructive pulmonary disease (COPD).~   "
119180|NCT02007577|"~     The possibility that obesity-associated inflammatory changes may play a role in the~     pathogenesis of type 2 diabetes (2DM) has led to increased interest in the possibility that~     salicylates might represent a useful treatment to improve glucose tolerance. Several studies,~     performed in patients with 2DM, as well as in nondiabetic, obese individuals, have~     demonstrated that salicylates have beneficial effects on glucose and insulin metabolism, but~     have not led to a coherent view as to the mechanism(s) involved.~      In this research proposal we will use specific methods to quantify insulin mediated glucose~     uptake (IMGU), glucose-stimulated insulin secretion rate (GS-ISR), and insulin clearance~     (I-Cl) in overweight/obese, nondiabetic, insulin resistant individuals. We will use the~     insulin suppression test (IST) to quantify IMGU in nondiabetic, overweight/obese volunteers~     to identify those individuals who are sufficiently insulin resistant to be enrolled in this~     study. We will then use the graded glucose infusion technique in these insulin resistant~     subjects to generate specific measures of both GS-IS and I-Cl. Following these baseline~     measurements, salsalate or placebo will be administered for one month to the participants,~     after which time the IST and the graded glucose infusion will be repeated to quantify and~     compare the changes in IMGU, GS-ISR, and I-Cl that have resulted from salsalate versus~     placebo. These results will provide for the first time quantitative data of the effect of~     salicylates on IMGU, GS-ISR, and I-Cl in overweight/obese, insulin resistant, nondiabetic~     individuals.~   "
119181|NCT02007564|"~     The research activities funded through PAR Dissemination and Implementation Research in~     Health in grant R21NR011112 Legacy Intervention Family Enactment (LIFE) have been varied~     and highly successful. The LIFE project was designed with three primary objectives. Aim 1 was~     to assess the efficacy of LIFE as delivered by Retired Senior Volunteers (RSVs) on palliative~     care patients': (a) mood and emotional experience; (b) physical symptom burden; and (c)~     experience of meaning. Aim 2 was to assess the efficacy of LIFE as delivered by RSVs on one~     primary family caregiver's: (a) caregiving stress; (b) mood and emotional experience; and (c)~     experience of positive aspects of caregiving. Aim 3 was to assess the ability of RSVs to~     deliver LIFE effectively.~      Although hospice and palliative care social workers frequently use reminiscence and creative~     activities with their patients 16, such interventions need to be more accessible to patients~     and families transitioning from community, hospital, and palliative care settings. If hospice~     or palliative care is not chosen as a treatment option, few means of delivering therapeutic~     reminiscence-based interventions exist. This represents a significant gap in practice and in~     the psychosocial palliative care intervention literature. Kazdin and Blase (2011) argue~     cogently that the community need for mental health services far outstrips the number of~     providers available to assist those in distress. They call strongly for new intervention~     delivery modes targeting prevention and treatment to alleviate suffering. Hence, the purpose~     of the present study was to evaluate the effectiveness of retired senior volunteers (RSVs),~     who are available nationally through the National Senior Corp Program, to deliver a~     three-session reminiscence and creative activity intervention previously found effective in~     improving palliative care patient and caregiver outcomes (Allen, 2009; Allen, Hilgeman, Ege,~     Shuster, & Burgio, 2008). We hypothesized that palliative care patients and their caregivers~     in the RSV-delivered intervention group would demonstrate improved emotional and spiritual~     functioning relative to a supportive contact control group. If successful, this mode of~     treatment delivery (e.g., RSV intervention) would represent a significant step toward~     translation and greater access at earlier disease stages of therapeutic psychosocial~     interventions for individuals near the end of life and their family members.~   "
119182|NCT02007551|"~     The purpose of this study is to evaluate the impact of a psychosocial and nutritional~     intervention, entitled RelAte, on cooking and mealtime behaviours of older adults who are~     living alone and at risk of social isolation. The intervention will be delivered in the home~     of participants by a trained volunteer of a similar age.~   "
119390|NCT02004821|"~     The purpose of this study is to evaluate the molecular differences between a group of~     Constitutionally Thin (CT) subjects and a group of controls.~   "
119184|NCT02007525|"~     The investigators propose to pilot test a six-week yoga program among adults with peripheral~     arterial disease (PAD). Participants (n=50) will be randomized to a six-week yoga~     intervention (n=25) or wait-list control (n=25). The yoga intervention will include a weekly~     yoga class currently used among cardiac rehab patients at the University of Michigan Health~     System, together with home-based practice sessions. Participants will perform treadmill~     testing at baseline and 6 weeks to assess walking capacity. The primary outcomes of interest~     include 1) acceptability of the program by participants, 2) feasibility of recruitment, 3)~     change in maximal walking distance, 4) change in claudication symptoms, and 5) change in~     health-related quality of life (HRQOL). The investigators expect this will inform us on the~     acceptability and feasibility of a larger proposal examining yoga in PAD patients. These data~     will also inform on the effect size in maximal walking, and HRQOL, which will be used to~     estimate the sample size needed for a larger R01 level proposal.~      Study hypotheses:~      Hypothesis 1: Participants will find the yoga program acceptable with low drop-out rates~     (<15%), excellent attendance (>80% classes attended), and good completion of the home-based~     practice sessions (self-report >80% completed).~      Hypothesis 2: The yoga intervention will be feasible for a larger study based on numbers of~     potential participants approached, and those who consent to participate vs. those who do not.~      Hypothesis 3: Increases in maximal walking distance and pain-free walking distance (from~     baseline to 6 weeks) will be greater in the participants randomized to the yoga intervention~     compared to the control group.~      Hypothesis 4: Self-reported claudication symptoms will be reduced to a greater degree (at 6~     weeks) among participants randomized to the yoga intervention compared to the control group.~      Hypothesis 5: Increases in HRQOL (from baseline to 6 weeks) will be greater in the~     participants randomized to the yoga intervention compared to the control group.~   "
119185|NCT02007512|"~     The purpose of this study is to determine if enzalutamide given in combination with~     exemestane is safe and effective in patients with advanced breast cancer.~   "
119186|NCT02007499|"~     The investigators hypothesized that pre-arrival instructions would increase the likelihood of~     bystanders performing Cardiopulmonary Resuscitation (CPR).~   "
119187|NCT02007486|"~     Dyspnea (breathlessness) on exertion is the most prevalent and distressing symptom of heart~     failure (HF). Nevertheless, the mechanisms of dyspnea in HF remain poorly understood. Thus,~     the general aim of this pilot study is to advance our understanding of the mechanisms of~     activity-related dyspnea in patients with HF. Studies will be performed in patients with~     mild, moderate and severe HF (n=24) as well as in healthy, age- and sex-matched control~     subjects (n=8). We will test the hypothesis that the increased prevalence and severity of~     activity-related dyspnea in HF reflects the interaction between an exaggerated drive to~     breathe and the inability of the respiratory system to meet this increased demand. Detailed~     physiological and perceptual responses to bicycle exercise will be examined and compared,~     first, between HF patients and healthy control subjects and, second, across patients with~     varying degrees of HF severity. The results from this preliminary study will be used to help~     design future studies in this patient population.~   "
119188|NCT02007473|"~     The objective of this non-interventional study is to gather data on adverse reactions~     occurring with Methylene Blue plasma administered in a routine clinical practice environment;~     to know more about their characteristics and behaviour and the possible factors that may~     influence their presentation and evolution.~   "
119189|NCT02007460|"~     Osteoporotic fractures are an extremely common and serious public health issue which~     contribute substantially to pain, impaired mobility and morbidity in the elderly. Declines in~     bone strength combined with an increase risk of falls (associated with decline in muscular~     function with age) are the main determinants of fracture risk. Exercise that is novel and~     involves impact loading has the potential to improve bone strength and neuromuscular function~     (strength, power and balance). It is thus imperative to evaluate potential benefits of~     exercise in older people. The musculoskeletal responses to exercise may also be influenced by~     vitamin D status. It is the purpose of this study to consider the influence of a one year~     unilateral (one limb) high impact exercise programme on musculoskeletal health, specifically~     bone structure, muscle strength and power in older caucasian men. It is also the purpose of~     this study to determine whether this differs according to vitamin D status. The findings will~     reveal whether exercise can improve bone health and/or neuromuscular function, and whether~     improvements are dependent upon vitamin D status.~   "
119190|NCT02007447|"~     This study is design to evaluate the influence of oxytocin in some aspects of Autism Spectrum~     Disorder (ASD), such as, repetitive and stereotyped behavior, social skills, quality of life~     and disruptive behaviors.~      Null hypothesis: social skills, quality of life, disruptive behaviors and repetitive~     behaviors do not improve with the use of oxytocin. Experimental Hypothesis: social skills,~     quality of life, disruptive behaviors and repetitive and stereotyped behaviors improve with~     the use of oxytocin.~   "
119191|NCT02007434|"~     The objectives of this study are to determine the safety of deoxycholic acid subcutaneous~     (SC) injections in the submental area and to evaluate the effects of four interventions,~     relative to placebo in the submental area, particularly with regard to assessment and~     management of pain, bruising, and swelling/edema.~   "
119192|NCT02007421|"~     SPANC stands for Study of the Prevention of Anal Cancer. There are more than 100 types of~     human papillomavirus (HPV). Some HPV types cause genital warts and other types cause more~     than 90% of anal cancer.~      Gay men are over 20 times more likely than others to develop anal cancer.~      SPANC is a study of anal (HPV) infection and related anal disease in gay men. The study will~     provide important information to guide the possible future introduction of anal cancer~     screening programs for gay men.~   "
119193|NCT02007408|"~     Objective: The investigators sought to investigate the analgesic efficiency of lidocaine~     spray, paracervical block (PCB) with lidocaine and PCB with lidocaine plus lidocaine spray~     combination in patients undergoing first-trimester surgical abortion.~      Methods: A randomized, double-blind, placebo-controlled clinical trial was conducted on 108~     women with the request of pregnancy termination.The subjects were randomly assigned into four~     groups: PCB (n=27), lidocaine spray (n=27), PCB plus lidocaine spray (n=27) and~     placebo(n=27).Intraoperative and postoperative pain scores were measured with a standard~     Visual Analog Scale (VAS).~   "
119194|NCT02007395|"~     Colonoscopy has been shown to reduce both the colo-rectal cancer incidence and mortality, due~     to its capability to detect and remove precancerous lesions. However, polypectomy is~     associated with complications, such as bleeding and perforation, with an estimated overall~     incidence of about 10%, with polyp size and right-sided location considered as major risk~     factors. Aim of present study was to prospectively evaluate the early and delayed (30-days~     follow-up) complications of polypectomy in a multicenter regional Italian real practice~     setting~   "
119220|NCT02007044|"~     You are being asked to take part in this study because you have chronic lymphocytic leukemia~     (CLL) with a chromosomal abnormality (17p/TP53 deletion) or CLL that has come back after~     treatment.~      The goal of this clinical research study is to learn if the combination of ibrutinib and~     rituximab can help to control CLL better than ibrutinib alone. The safety of these treatments~     will be also studied.~   "
119195|NCT02007369|"~     According to the Census & Statistics Department, there are still 659,300 daily smokers~     (11.1%) in Hong Kong. Smoking is addictive, and it is difficult for some motivated smokers to~     quit without assistance. About 33.2% daily smokers in Hong Kong had tried quitting but they~     could not maintain abstinence. Relapse prevention is aimed at providing interventions to~     prevent relapse after starting the abstinence status. This pilot single-blind randomized~     controlled trial (proof of concept study) will test the effectiveness of social networking~     services for relapse prevention. The study will first recruit 6 quitters and 6 relapsers for~     a qualitative interview for the design of intervention. Then, the pilot-RCT trial will~     recruit 120 participants who have recently quitted smoking, and they will be randomly~     allocated to 2 intervention groups and one control group. The 2 intervention groups will be~     arranged to join a WhatsApp or Facebook group for receiving quitting advices from the group~     moderators and sharing quitting experience with other participants. All participants will~     receive a self-help booklet of relapse prevention, and will be followed up at 6 weeks, 3~     months and 6 months. The primary outcome is the self-report relapse rate (Relapse is~     tentatively defined as smoking 5 cigarettes in 3 consecutive days since joining the RCT among~     the 3 study arms.~   "
119196|NCT02007356|"~     To assess the feasibility of donor-derived interferon (IFN)-γ positive select-ed~     virus-specific T-cells using the cytokine capture system® (CCS) and the safety of subsequent~     infusion in recipients of hematopoietic stem cell transplantation (HSCT) with treatment~     refractory post-transplant viral infections. The CCS has already been successfully used in~     clinical studies in Germany and United Kingdom (UK).~   "
119197|NCT02007343|"~     This study aims to assess how large an additional disease burden and what extra costs are~     generated by antibiotic resistance in patients suffering from infections caused by~     gram-negative bacteria, such as Escherichia coli and Pseudomonas aeruginosa, in hospitals in~     the Netherlands.~   "
119198|NCT02007330|"~     Systemic lidocaine administration may improve postoperative pain and recovery after~     laparoscopic inguinal hernia repair in pediatric patients~   "
119199|NCT02007317|"~     This study is single-arm, none randomized, open label, two-dose-cohorts, single center~     clinical trial for evaluation of the safety and efficacy of Oshadi D and Oshadi R in patients~     with BCC. Patients will receive Oshadi D and Oshadi R for 60 -90 days until the planned~     surgical excision of the lesion.~   "
119200|NCT02007304|"~     The purpose of is to determine the preventive effects of Chinese herb supplement with panax~     ginseng and salvia miltiorrhiza prior to eccentric resistance exercise on arterial stiffness~     and vascular reactivity by using a double-blind randomized control design and to examine the~     effects of a 12-week progressive eccentric resistance exercise training on arterial~     elasticity and vascular reactivity, and whether a long-term supplementation would ameliorate~     arterial stiffening effects elicited by exercise-induced inflammation and improve endothelial~     function.~   "
119201|NCT02007291|"~     Life expectancy in Brazil has increased markedly over the last 30 years. Hence, age-related~     disorders, such as Alzheimer's disease (AD), warrant special attention due to their high~     prevalence in the elderly. Pharmacologic treatment of AD is based on cholinesterase~     inhibitors (ChEI) and memantine, leading to modest clinical benefits both in the short and~     long-term.~      However, clinical response is heterogeneous and needs further investigation. Objective: To~     investigate the rate of response to ChEI in AD after three months of treatment. Methods:~     Patients with mild or moderate dementia due to probable AD or to AD associated with~     cerebrovascular disease were included in the study.~   "
119202|NCT02007278|"~     The purpose of this study was to compare the effect of a fixed dose combination of~     vildagliptin plus metformin versus combination therapy of glimepiride plus metformin in~     glycemic variability in patients with type 2 diabetes who have not achieved adequate control~     of their disease prior to treatment with metformin monotherapy in optimal doses.~   "
119203|NCT02007265|"~     The purpose of this study is to determine whether simple, evidence-based clinical screening~     be quickly and feasibly implemented (>85% of patients in an average of <6 minutes) in~     large-volume urgent transient ischemic attack (TIA)/stroke clinics to identify individuals at~     high risk for the three most common and devastating post-stroke co-morbidities (depression,~     obstructive sleep apnea and cognitive disorders).~   "
119204|NCT02007252|"~     This study was designed to assess the safety, tolerability and efficacy of ACZ885 on~     aneurysmal growth rate in subjects with abdominal aortic aneurysms (AAA). The purpose of the~     study was to provide data to enable decisions regarding the further development of ACZ885 for~     subjects with abdominal aortic aneurysms. The design of this study addressed the primary~     objective of evaluating the change in aneurysmal size in subjects with AAA as a result of~     treatment with ACZ885.~   "
119205|NCT02007239|"~     This study seeks to determine the efficacy of tocilizumab (TCZ) in patients with~     hemophagocytic lymphohistiocytosis (HLH) and high cytokine levels (proteins involved in~     inflammation) in an attempt to decrease the damage caused by these proteins; and secondarily~     to assess its safety and impact on disease activity.~   "
119206|NCT02007226|"~     Although conventional risk factors for coronary heart disease (CHD) have been identified and~     routinely used to determine risk for CHD in the general population, a systematic approach to~     determine population-specific risk for CHD has not been performed prospectively in those with~     SCI. CHD is a leading cause of death in spinal cord injury, occurring at younger ages than in~     the able-bodied population. Conventional risk factors for CHD are high serum concentrations~     of low-density lipoprotein (LDL), low serum concentrations of high-density lipoprotein (HDL),~     diabetes mellitus (DM), positive smoking history, and positive family history of premature~     CHD.~      Coronary Artery calcification (CAC) is a commonly occurring phenomenon that does not~     necessarily indicate significant obstructive disease. Studies have shown that a strong~     association exists between coronary calcification and coronary heart disease. The purpose of~     this study is to compare the CAC scores in persons with SCI with a historical control group~     of able-bodied persons from a national data base who will be matched for conventional risk~     factors for coronary artery disease (CAD) and to determine the relationship between CAC~     scores and conventional and emerging risk factors for CAD. Additionally, postprandial lipemic~     (elevated levels of lipids following ingestion of food) responses among individuals with SCI~     and control subjects will be compared, as well as the response of inflammatory markers~     following a high fat meal. Participants will only be tested once for these parameters.~   "
119207|NCT02007213|"~     Patient reported outcomes (PROs) instruments are often used to measure meaningful treatment~     benefit or risk in clinical trials. PROs allow patients voices to be heard in ways that~     assist healthcare clinicians to address treatment effects and individual patient preferences.~     Unfortunately, infants and young children, especially those with a debilitating disease, such~     as neuromuscular disorders (NMD), may be less able to provide clear and concise information~     about treatment effects. In this case, we often defer to parents and guardians (to be~     referred to collectively as parents throughout protocol) to provide their perception of their~     child s overall health and wellbeing. Including parents in the assessment process recognizes~     the unique knowledge parents have of their child s development, reinforces their central role~     in implementing interventions, and aids in their ability to make better-informed healthcare~     decisions [1]. Yet, most parent-reports for young children are confined to overall quality of~     life (QoL). While QoL is an important area of assessment, its meaning varies among different~     ages and populations, and its results are often not precise enough to reveal small~     differences within samples [2]. A more specific area of concern in children with NMD is~     early-onset muscle weakness leading to difficulties in motor function.~      The current lack of patient-centered, sensitive measures (based on motor function and item~     difficulty hierarchy) that are suited for repeated assessments in infants and young children~     with NMD represents a major obstacle to the rapid translation of promising therapeutic~     interventions from preclinical models to clinical research studies. Multiple clinical outcome~     measures used at a single time-point for capturing a child s functional status are~     burdensome, difficult to interpret and do not provide us with comprehensive, meaningful~     information to detect changes following an intervention [3]. Psychometric measures that can~     be completed by parents make it possible to collect a considerable amount of data over many~     time-points rather than being limited to a single clinical observation. Moreover, a~     parent-observational measure that focuses on their child s functional performance in their~     real-life will maximize the ecological validity of measures of motor development used for~     clinical trials.~      Objective: To develop a parent reported observational measure of motor development in infants~     and young children, which will serve as a complimentary tool to clinical observation by~     reporting motor function as observed in the home setting and which will be used in clinical~     trials.~      Study population: Parents of children aged 0-5 with neuromuscular disease and neuromuscular~     experts in pediatrics.~      Design: Qualitative (parent interviews, focus groups) and quantitative study (analysis of~     newly developed questionnaire)~      Outcome Measures: parental responses to phone interviews, neuromuscular expert responses to~     focus groups, parental responses to cognitive interviews, validity and reliability of newly~     developed questionnaire~   "
119210|NCT02007174|"~     Blockade of vascular endothelial growth factor (VEGF) with bevacizumab has been used to treat~     abnormal vascular conditions of the anterior segment of the eye. In pterygium, anti-VEGF~     agents have been recently proposed as primary treatments, such as perioperative adjuvants, as~     well as treatments for pterygia recurrences after surgery. The aim of the present study was~     to prospectively evaluate the effect of three subconjunctival bevacizumab injections in~     patients with an early pterygium recurrence. Materials and Methods: The current study was a~     non-randomized single central trial. The method of ensuring allocation concealment was~     sequentially numbered. Patients with an early pterygium recurrence were selected and invited~     to participate in the study. Recurrence was defined as the presence of corneal vessels with~     concomitant conjunctival hyperemia within the first trimester after primary pterygium~     removal, and only patients with primary pterygium recurrence were included. Patient related~     factors such as pregnancy, women seeking to become pregnant, and lactating women were~     excluded from the study. All patients received three subconjunctival bevacizumab (2.5 mg/0.05~     ml) injections (basal, 2 and 4 weeks) in the recurrence area of the pterygium, and were~     photographed at the third, sixth and twelfth months after the last bevacizumab injection.~     Photographic analyses were performed taking into account two pterygium areas: the first~     measure included only the vessel area in the corneal surface, while the second measure~     included, both, conjunctival and corneal vessel area (corneal-conjunctival area of~     hyperemia). Neovascularization area of each pterygium was determined using digital slit lam~     pictures, which were analyzed using Photoshop CS4, in order to get pixels measurements of the~     lesion.~   "
119211|NCT02007161|"~     Investigate the supersaturation and precipitation behaviour of diclofenac in the stomach of~     healthy volunteers.~   "
119212|NCT02007148|"~     Second-line chemotherapy represents an option in gastric cancer, especially for patients with~     adequate performance status. Two randomized phase III trials comparing 2nd-line docetaxel~     with best-supportive care have reported a benefit in favor of chemotherapy. Capecitabine is a~     fluoropyrimidine carbamate, which has a broader spectrum of antitumor activity than other~     fluoropyrimidines. In gastric cancer xenografts. metronomic capecitabine inhibited~     angiogenesis, growth of gastric cancer and improved survival with less toxicity. Given its~     potential low toxicity, the combination of docetaxel and metronomic capecitabine needs to be~     evaluated to assess efficacy and tolerability in patients with advanced gastric cancer~     previously treated with a fluoropyrimidine-based and platinum-based chemotherapy.~   "
119213|NCT02007135|"~     The purpose of this study is to determine the concurrent validity of a newly developed~     pneumatic, fMRI compatible muscle vibrator as compared to a electromagnetic muscle vibrator~     in the stimulation of muscle proprioceptors.~   "
119214|NCT02007122|"~     The study will be conducted to investigate the pharmacokinetics of ceftaroline during~     continuous and intermittent renal replacement therapy.~   "
119215|NCT02007109|"~     Pediatric research in the management of nausea has been limited by the absence of a reliable~     method to quantify the intensity of this subjective symptom. In adults, the visual analog~     scale (VAS) is an accurate tool, but this has not been shown to be reliable in young~     children. A scale is a series of points made on a line that will be used for measurement; a~     mark on the far left of the line shows little pain and the mark on the far right means alot~     of pain.~   "
119216|NCT02007096|"~     The purpose of this study is to determine if a Transabdominal Plane Block will decrease~     patient pain and pain medication use after a laparoscopic ventral (ventral, umbilical,~     incisional) hernia repair with mesh.~   "
119217|NCT02007083|"~     Lumbar Spinal Stenosis (LSS) is a clinical entity were narrowing of the spinal canal gives a~     compression of the the neural and vascular structures in the spinal canal. This often gives~     neurogenic claudication and sometimes severe Low Back Pain (LBP). Surgery for LSS is today~     the most often performed procedure in the adult lumbar spine. Beneficial effect of surgical~     treatment is well documented by several clinical trials, and a Cochrane review article from~     2005 concludes that surgical treatment is superior to non-surgical treatment. The surgical~     solution is to decompress the stenotic part of the lumbar spine. There is no consensus in the~     literature of which surgical method that gives best long term clinical results. The~     investigators are therefore planning a Randomized Controlled Trial, where they will compare~     clinical and radiological results of three different surgical methods for LSS. The main~     outcome of this study is to answer which surgical method that gives the best long term~     clinical results. And, secondary outcome is to find out how much increase of the Dural Sac~     Cross Sectional Area is needed to give a long time relief of the patients` symptoms.~   "
119218|NCT02007070|"~     This study is being done to evaluate the safety and efficacy of pembrolizumab (MK-3475) in~     participants with advanced non-small cell lung cancer (NSCLC) tumors that are positive for~     programmed cell death ligand 1 (PD-L1): the hypothesis is that treatment with pembrolizumab~     will result in a clinically meaningful Overall Response Rate (ORR).~   "
119219|NCT02007057|"~     Most arthroscopic surgeries of the shoulder are currently performed as an outpatient. The~     postoperative analgesia should be optimal. General anesthesia allows for any arthroscopic~     surgery but does not provide a satisfactory postoperative analgesia . The locoregional~     anesthesia is recommended and includes several techniques: the interscalene nerve block, the~     suprascapular nerve block, intra-articular injection of local anesthetic and subacromial~     infiltration. The interscalene nerve block is currently the gold standard for anesthesia and~     postoperative analgesia for arthroscopic shoulder surgery with a success rate above 80% .~     However it must be carried out by teams experienced in the locoregional anesthesia because it~     is operator -dependent. The suprascapular nerve block is a simple technique that can be~     performed by the surgeon after surgery , effective in arthroscopic shoulder surgery , less~     invasive than the interscalene nerve block and exposing the patient to fewer complications.~     However, his interest was not assessed in the repair of tendons of the rotator cuff. The main~     hypothesis of this study is that the suprascapular nerve block is as effective as the~     interscalene nerve block in the prevention of early postoperative pain after arthroscopic~     repair of the infra and / or the supraspinatus rotator cuff tendons, without increasing the~     analgesic consumption while reducing the risk of complications related to regional~     anesthesia.~   "
119235|NCT02006849|"~     The purpose of this research study is to determine if the study drug H.C. Acthar gel slows~     the progression of your kidney disease. This drug is a steroid-based medicine with fewer side~     effects than other steroids used for treatment of kidney diseases similar to APOL1~     nephropathy.~   "
119221|NCT02007031|"~     Wintertime is associated with increased morbidity and mortality and a majority is related to~     cardiovascular causes, such as myocardial infarctions, heart failures, and strokes. It is~     also known, that both acute and long-term cold exposure increase blood pressure and cardiac~     workload, and this may contribute to the observed excess morbidity and mortality during the~     cold season.~      Although the effects of cold on blood pressure are known among healthy people, these~     responses among risk groups, such as hypertensive people, are not established. In addition,~     changes in cardiac electrical activity or autonomic regulation are largely unknown. The~     cardiovascular responses in the cold could be different among hypertensive people because of~     disturbances in the circulatory regulation or function, such as aortic stiffening and~     increased vasomotor tone of peripheral arteries due to endothelial dysfunction associated~     with the disease. To assess this, a controlled experiment employing a cold exposure similar~     to everyday winter circumstances in a subarctic climate was performed.~   "
119222|NCT02007018|"~     The purpose of this study is to determine, in patients who undergo an elective colorectal~     resection through a midline laparotomy incision, whether the use of negative pressure wound~     therapy (NPWT) applied to the site of the laparotomy compared to standard care alone, reduces~     the incidence of surgical site infection (SSI) in the first 30 days postoperatively. The~     investigators hypothesize that the use of NPWT will reduce the rate of postoperative SSI, as~     well as decrease the need for Nursing Home Care for SSI, length of hospital stay and return~     visits related to SSI.~   "
119223|NCT02007005|"~     The aim of this phase Ib/IIa study is to investigate the maximum tolerable concentration of~     abnobaVISCUM® Fraxini for intravesical instillation in patients with superficial bladder~     cancer. Secondary objectives are the local and systemic tolerability, the influence on tumor~     remission and the influence on the one-year recurrence rate.~   "
119224|NCT02006992|"~     Effects on weight and weight gain will be monitored in healthy term infants fed assigned~     infant formulas.~   "
119225|NCT02006979|"~     In rodents, a single bout of exercise prior to injection of a chemotherapy agent used to~     treat breast cancer prevents or attenuates a number of markers of cardiac injury. This study~     will investigate whether this finding translates to human breast cancer patients.~     Participants scheduled to receive chemotherapy for breast cancer will be randomized to~     exercise or no exercise 24 hours prior to every chemotherapy treatment. The effect on cardiac~     function will be compared between groups noninvasively by echocardiography and~     electrocardiography and a venous blood draw at baseline before chemotherapy, after the first~     treatment and at the end of chemotherapy.~   "
119226|NCT02006966|"~     Systemic lidocaine infusion may improve the patients' chronic post surgical pain after~     video-assisted thoracic surgery~   "
119227|NCT02006953|"~     The purpose of this study is to determine the best way to feed children after they have a~     gastrostomy tube placed. The study compares bolus feeding to continuous feeding.~   "
119228|NCT02006940|"~     The study is devoted to the comparative analysis of the data received in patients with lung~     pathology using new method of probe-based confocal laser endoscopy of distal airways and two~     reference methods: high resolution computed tomography and morphology.~   "
119229|NCT02006927|"~     The goal of this study is to evaluate electrical stimulation of nerves responsible for~     erectile function after surgery to remove the prostate (prostatectomy). Electrical~     stimulation of the nerves responsible for erectile function is experimental. The~     investigators hypothesize that the subjects can tolerate nerve stimulation.~   "
119230|NCT02006914|"~     This research is to investigate the nutritional supplement chromium picolinate. The~     investigators are testing to see how effective this supplement is in treating insulin~     resistance associated with HIV disease.~   "
119231|NCT02006901|"~     Introduction: This observational study is designed to test the equivalence between the~     clinical effectiveness of microdecompression and laminectomy in the surgical treatment of~     central lumbar spinal stenosis. Lumbar spinal stenosis is the most frequent indication for~     spinal surgery in the elderly, and as the oldest segment of the population continues to grow~     its prevalence is likely to increase. However, data on surgical outcomes are limited. Open or~     wide decompressive laminectomy, often combined with medial facetectomy and foraminotomy, was~     formerly the standard treatment. In recent years a growing tendency towards less invasive~     decompressive procedures has emerged. Many spine surgeons today perform microdecompression~     for central lumbar spinal stenosis.~      Prospectively registered treatment and outcome data are obtained from the Norwegian Registry~     for Spine Surgery (NORspine).~   "
119232|NCT02006888|"~     The purpose of this study is to determine whether IBI-10090 injection is effective in the~     treatment of inflammation associated with cataract surgery.~   "
119233|NCT02006875|"~     To use repetitive transcranial magnetic stimulation (rTMS) to treat stroke patients is~     getting a popular idea. Previous studies seemed to support its effects on facilitating motor~     recovery after stroke. This study focuses on the motor recovery of lower extremities.~     Investigators conducted the study to evaluate the treatment effect of rTMS on the functional~     performance of lower extremities in terms of postural control, balance, and mobility in~     stroke patients. Investigators hypothesized that these performances could be improved through~     the better motor control of lower extremities caused by rTMS.~   "
119234|NCT02006862|"~     This clinical observational study aims to investigate the efficacy of olanzapine (Villamos ®)~     in accordance with the instructions attached thereto in standard clinical practice, followed~     by the physician to the patient.~      This is a multicenter, non- interventional observational study , 6-month period without~     preparing the patient to take the usual his medication . A total of 3 scheduled visits :~     Visit 1 to Day 0 ( integration , base ) , Visit 2 at month 3 and Visit 3 at month 6 ( = end~     of treatment) .~      The purpose of the study is to demonstrate the efficacy and safety of olanzapine in patients~     who are indicated . Will be monitored and recorded all the different concomitant therapy .~     The treatment of each patient is an individual designated by the physician , according to~     standard clinical practice and without any intervention research purpose .~      During the six months of observation patients visit the clinic at the beginning (day 0 ),~     intermediate ( 3 months ) and end (month 6). The purpose of these visits is regularly~     monitored by their doctor for senile dementia and their behavior .~   "
139649|NCT01739452|"~     Reviewing Spanish record of myelodysplastic syndromes (RESMD) data base in the group of~     patients with MDS. The information will be collected retrospectively from diagnosis of MDS,~     until the date of December 31, 2011.~   "
119237|NCT02006823|"~     This study will explore ways to improve the effectiveness of patient Self Management at a~     time when genetic test results guide new treatments that will dramatically increase the~     possibility of cure of the hepatitis C virus.The study will also focus on the interactions~     between provider and patients and the ways that technical work, adaptive work and adaptive~     leadership foster patient self-management.This proposed 2 year exploratory mixed-methods 12~     longitudinal case study will explore patients' and providers' explanations for how and why~     they engage in technical work, adaptive work, and adaptive leadership and the ways in which~     these strategies promote or pose barriers to patients' self-management of Chronic Hepatitis C~     in the context of the new genetic test results and treatments. Specific aims are to:~      1: Examine how technical work, adaptive work and adaptive leadership influence patients'~     perceptions of their likelihood of cure and how this work relates to self-management during~     12 to 24 weeks of treatment for Chronic Hepatitis C. Research questions are: 1.1) How do~     patients describe their interactions with the providers? 1.2) How do these interactions shape~     patients' perceptions of the likelihood of cure? 1.3) How do patients' understanding of their~     interactions with the provider promote the use of or pose barriers to self-management during~     treatment?~      AIM 2: Describe providers' use of technical work, and adaptive leadership approaches during~     clinical encounters,to include nurse education visits. Research questions are:~      2.1) What technical work, and adaptive leadership approaches do providers use when sharing~     treatment information with patients during the clinical encounters. 2.2) What explanations do~     providers give for how and why they use technical work and adaptive leadership approaches?~     AIM 3: Describe the trajectories of illness perceptions(Control/Cure sub-scale - Illness~     Perception Scale), symptoms (M.D. Anderson Symptom Inventory) , viral load, and~     self-management (Patient Activation Measure) in relation to patient and provider reports of~     technical work, adaptive work, and adaptive leadership from the index clinical encounter to~     the follow-up treatment response encounter (ranging from 12 to 24 weeks).~   "
119238|NCT02006810|"~     The main objective is to develop and validate new endothelial function markers discriminating~     and reproducible by assessing the ability to reveal changes in endothelial function in~     response to positive and negative nutritional stimuli.~   "
119239|NCT02006797|"~     This study will evaluate the impact of a communication between hospital pharmacist and~     community pharmacists in addition to drugs reconciliation procedure at discharge. It will be~     conducted in 21 french public hospitals.~   "
119240|NCT02006784|"~     This is an open label, pilot, observational, prospective study of the safety of inactivated~     influenza vaccine (IIV) in children with systemic lupus erythematosus (SLE) to be conducted~     during the 2013-2014 influenza season. The study will test conventional and novel biomarkers~     to assess disease flare and vaccine response and will also collect self-reported~     signs/symptoms in reactogenicity diaries during the 14 days after vaccination.~   "
119241|NCT02006771|"~     This one-year randomized crossover study is proposed to compare the changes of postprandial~     oxidative stress (POS) after consumption of meals from different cultures in healthy Chinese~     adults, using a 'real-life, cultural meal' approach. It is hypothesized that the changes of~     POS differ with meals from different cultures. Four cultural meals are chosen, namely~     Southern Chinese, Northern Chinese, American, and South Indian, based on the known prevalence~     of chronic diseases between Caucasians, Chinese and Indians, and within the Southern and~     Northern Chinese population.~   "
119242|NCT02006758|"~     The purpose of this observational study is to further evaluate the safety and performance of~     the EnligHTN™ Renal Denervation System in the treatment of patients with uncontrolled~     hypertension in clinical routine practice.~   "
119243|NCT02006745|"~     The purpose of the study is to explore the treatment of patients with acute hepatitis C~     infection (infection acquired within the last 6 months) who are also infected with human~     immunodeficiency virus (HIV).~   "
119244|NCT02006732|"~     The objective of this study is to assess the efficacy and safety of 12 weeks once daily~     treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the Respimat inhaler)~     compared with tiotropium and placebo in patients with COPD.~   "
119245|NCT02006719|"~     The objectives of this study are to assess the safety, effectiveness, and immunogenicity of~     AA4500 in the treatment of adhesive capsulitis.~   "
119246|NCT02006706|"~     This study will evaluate the efficacy and safety of MabThera/Rituxan plus methotrexate in~     patients with active rheumatoid arthritis who have had an inadequate response to at least 1~     DMARD treatment. All patients will receive MabThera (1000mg iv infusion) on days 1 and 15,~     and methotrexate (10-25mg po) weekly. The anticipated time on study treatment is 3-12 months.~   "
119247|NCT02006693|"~     The objective of this study is to evaluate the AqueSys XEN Implant for the treatment of~     moderate primary open angle glaucoma patients when medications have failed to control~     intraocular pressure (IOP). Effectiveness will be evaluated by comparing medicated~     preoperative, intraocular pressure to postoperative values. Additionally, the number of IOP~     lowering medications subjects are on at each study visit will be compared to preoperative~     medication.~   "
119248|NCT02006680|"~     The best way to measure whether treatment of children with central precocious puberty is~     working is to do a hormone stimulation test (leuprolide stimulation test) that requires~     injection of a medication and multiple blood draws to see if the hormonal response is~     suppressed (blocked). The hypothesis of this study is that random measurement of the free~     alpha subunit of pituitary glycoprotein, a protein related to the pituitary hormones that~     stimulate puberty, will provide an adequate alternative to the leuprolide stimulation testfor~     monitoring efficacy of pubertal suppression with Supprelin LA®.~   "
119249|NCT02006667|"~     This study will evaluate the efficacy and safety of a chemotherapy regimen of intravenous~     Herceptin, cisplatin and gemcitabine in patients with metastatic urothelial cancer. The~     anticipated time on study treatment is until disease progression.~   "
119250|NCT02006654|"~     To establish efficacy of idalopirdine as adjunctive therapy to acetylcholinesterase~     inhibitors (AChEIs) for symptomatic treatment of patients with mild-moderate Alzheimer's~     disease (AD).~   "
119251|NCT02006641|"~     To establish efficacy of Idalopirdine as adjunctive therapy to donepezil for symptomatic~     treatment of patients with mild-to-moderate Alzheimer's disease (AD).~   "
119252|NCT02006628|"~     A study to compare the change in symptom severity in patients with schizophrenia or related~     psychotic disorder when treated with GWP42003 or placebo, added to existing anti-psychotic~     therapy over a period of six weeks. Secondary objectives are to evaluate the effect of~     GWP42003 on quality of life and cognition and to assess the safety and tolerability of~     GWP42003.~   "
119253|NCT02006615|"~     We hypothesize that ten sessions of repetitive transcranial magnetic stimulation yield~     ability to upregulate the function of primary motor cortex and prefrontal cortex that play~     key roles in motor and frontal memory processing.~   "
119311|NCT02005848|"~     A Phase II, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Study Evaluating the~     Efficacy and Safety of Human, Alpha-1 Antitrypsin (AAT) [Glassia®] in the Treatment of New~     Onset Type-1 Diabetes.~      The study objectives are:~        -  To assess the efficacy of intravenous AAT in treatment of new onset Type 1 Diabetes~        -  To assess the safety and tolerability of intravenous AAT in new onset Type 1 Diabetes~          pediatric and young adult population.~   "
119254|NCT02006602|"~     This will be an open-label, randomized, single dose, two-way crossover study. Each subject~     will participate in both treatment periods and will receive single oral doses of candesartan~     cilexetil (GW615775) and reference candesartan cilexetil (ATACAND™); the treatment periods~     will be separated by a washout period of at least 7 days and no greater than 14 days. This~     study aims to determine the relative bioavailability of a 16mg test formulation tablet of~     candesartan cilexetil (GW615775) compared to an 16mg reference tablet of candesartan~     cilexetil in healthy adult subjects. ATACAND is a registered trademark of the Astra/Zeneca~     group of companies.~   "
119255|NCT02006589|"~     This will be an open-label, randomized, single dose, two-way crossover study. Each subject~     will participate in both treatment periods and will receive single oral doses of candesartan~     cilexetil (GW615775) and reference candesartan cilexetil (ATACAND™); the treatment periods~     will be separated by a washout period of at least 7 days and no greater than 14 days. This~     study aims to determine the relative bioavailability of an 8mg test formulation tablet of~     candesartan cilexetil (GW615775) compared to an 8mg reference tablet of candesartan cilexetil~     in healthy adult subjects. ATACAND is a registered trademark of the AstraZeneca group of~     companies.~   "
119256|NCT02006576|"~     The Prostaglandin Inhibition for Emphysema (PIE) study will determine if a currently~     available therapy, ibuprofen 600 mg three times daily, can block PGE production in the lower~     respiratory tract and if this results in improvement in measures of lung repair function.~   "
119257|NCT02006563|"~     -  Metabolic Tumor Volume (MTV), identified by Magnetic Resonance Spectroscopic Imaging~          (MRSI) is different from the Clinical Target Volume (CTV) used for radiation dose~          delivery in the treatment of brain tumors.~        -  If MTV > CTV, the investigators hypothesize that the difference in volumes (cc) is~          related to worse clinical outcome. Furthermore, in case of local recurrence, the lesion~          is located in the MTV area that is outside of the CTV.~        -  Alternatively, if CTV > MTV, then the difference in volumes is related to higher~          treatment toxicity.~   "
119258|NCT02006550|"~     Cancer results when undifferentiated cells grow in an uncontrolled manner, crowding out~     normal cells, causing morbidity and ultimately mortality. The cancer stem cell theory~     suggests that most tumors undergo a process of differentiation through which a relatively~     rare cancer stem or progenitor cell (CSC) gives rise to more differentiated populations of~     cells (including transiently amplifying cells) comprising the bulk of the tumor. As a result~     of this cellular diversity, one or more cells within the tumor are likely to be resistant to~     therapy. Among cells resistant to a given therapy, only CSCs can repopulate the tumor. A key~     feature of this resistant subset of CSCs is that they repopulate a tumor resistant to the~     original intervention. The cellular programs driving the uncontrolled proliferation of many~     solid tumors result from aberrant activity of Wnt, Shh, and/or Notch signaling pathways in~     CSC. Thus, therapies that down-regulate the activity of these fundamental pathways in CSCs~     will be effective in the treatment of cancer. The investigators' research program focuses on~     the elucidation of signaling mechanisms, control of cellular processes and discovery of small~     molecules that selectively target Wnt, Shh, and Notch signaling pathways that are fundamental~     to CSCs. Our preliminary results identified a novel Notch associated protein NACK that~     functions as a transcriptional co-activator of Notch. Moreover, Nack is expressed in human~     solid tumors and is required for cell survival and tumor growth in notch -dependent tumor~     cells. The investigators' aim is to further interrogate the link between Notch and Nack.~   "
119259|NCT02006537|"~     This study will investigate the safety and pharmacokinetics (PK) of a single dose of~     GSK2256294 in healthy young and elderly subjects to explore the effects of food, gender and~     age on drug exposure. The biliary metabolites in healthy young males will be investigated~     using the Entero-test after a single oral dose of GSK2256294. This study will be conducted in~     two cohorts (Cohort 1 and Cohort 2). Cohort 1 is open label in order to characterise the PK~     profile of GSK2256294 in healthy young males and also to investigate the biliary metabolites~     of GSK2256294. Cohort 2 uses a crossover design to allow comparison of the PK parameters of~     GSK2256294 between in the fed and fasted state within subject and also to compare the PK~     parameters of GSK2256294 between male and female subjects. A washout period of a minimum of 2~     weeks has been chosen to allow and adequate washout of GSK2256294.~   "
119260|NCT02006524|"~     Silent atrial fibrillation is an important cause of unnecessary strokes. If diagnosed and~     treated in time with anticoagulants, many disabling strokes can be prevented. In order to~     improve the diagnosis of atrial fibrillation the MyDiagnostick is developed; a user friendly~     and easy to use stick that diagnoses atrial fibrillation in one minute. During influenza~     vaccination, many patients who are also at risk for atrial fibrillation visit the general~     practice. This offers an ideal opportunity for screening for atrial fibrillation. The study~     investigates the yield of screening for atrial fibrillation with the MyDiagnostick during~     influenza vaccination (newly detected atrial fibrillation with corresponding CHA2DS2-Vasc~     score).~   "
119261|NCT02006511|"~     Wound complications associated with surgical incisions range from minor to life threatening.~     Surgical site infections occurring usually occur within 30 days and are one of the most~     common surgical complications. Perigraft infections in groin wounds can be devastating. Even~     superficial wounds can progress to deep wounds resulting in graft infection, need for~     explantation, and sepsis or amputation requirement. Negative pressure wound therapy has had~     favorable results on closed wounds in trauma populations. Similarly, negative pressure wound~     therapy has had positive benefits in closed incisions such as sternal wounds following~     cardiac surgery. As a result, the PrevenaTM Incision Management System(IMS) was developed to~     allow easier application of negative pressure therapy to closed wounds. Application of the~     PrevenaTM IMS dressing would portend the aforementioned benefits of Vacuum Assisted Closure~     (VAC®) therapy with the added benefits of protecting the wound from contamination and~     bolstering the wound edges for better approximation and consequently better aesthetic~     outcome. However, no comparison between negative pressure therapy as a dressing and standard~     wound dressings exists.~      The purpose of this study is to assess the efficacy and safety of topical negative pressure~     therapy application with Prevena™ versus standard of care wound therapy on closed groin~     incisions in high risk patients undergoing vascular surgery.~   "
119262|NCT02006498|"~     This is a randomised study to examine whether high dose Sillymarin will be able to help~     improve fat-induced liver damage in the liver. The study hypothesis is that high dose~     Sillymarin will be able to reduce steato-hepatitis (fat-related liver inflammation) better~     than placebo.~   "
119267|NCT02006433|"~     The Investigators propose an investigation of the safety of deep brain stimulation (DBS) for~     the alleviation of chronic neuropathic pain in patients with spinal cord injury (SCI).~      Aim 1 is to determine whether DBS in the periaqueductal/periventricular gray region (PAG/PVG)~     of the brain at analgesic intensities produces any systemic or neurological adverse effects~     in patients with longstanding SCI (>1 year), either immediately or as a result of prolonged~     application for up 40 weeks.~      Aim 2 is to determine whether acute application of DBS in the PAG/PVG influences the severity~     of spontaneous ongoing pain caused by longstanding SCI.~      Aim 3 is to determine whether DBS in the PAG/PVG affects stimulus-evoked or persistent~     hypertension (a major sign of autonomic dysreflexia) in chronic SCI patients.~      Aim 4 is to determine whether prolonged PAG/PVG stimulation (for 40 weeks) leads to~     cumulative changes in chronic pain severity or in the motor or autonomic symptoms of chronic~     SCI patients.~   "
119268|NCT02006420|"~     Scleroderma as well as numerous other rheumatologic conditions can affect the skin.~     Scleroderma in particular involves skin thickening and hardening. Currently, evaluation of~     skin involvement by scleroderma is assessed based on a combination of physical examination~     and histologic assessment after biopsy. The investigators propose to measure skin hardness~     using ultrasound elasticity imaging, in the form of acoustic radiation force impulse/shear~     wave velocity imaging (ARFI/SVI). The investigators hypothesize that ARFI/SVI may be able to~     distinguish normal skin from skin affected by scleroderma (and other rheumatologic~     conditions) as well as perhaps quantify the amount of fibrosis in the dermis. Such a~     radiologic biomarker could be used to help confirm the diagnosis of scleroderma as well as to~     follow patients over time and assess response to therapy and progression of disease.~   "
119269|NCT02006407|"~     This is a pilot study to assess the changes in white matter, in the brain, in response to~     radiation therapy and correlate these changes with later declines in cognitive function.~   "
119270|NCT02006394|"~     Clinical and rodent studies have demonstrated the impact of specific dietary factors in~     modulating inflammation-related diseases including insulin resistance, type 2 diabetes, and~     cardiovascular disease. Such dietary factors include polyunsaturated fats, polyphenols, and~     glycemic index. The investigators know from previous studies in the literature that reducing~     the glycemic index and increasing the omega-3 fat and polyphenol content of the diet results~     in improved metabolic indices and reduced inflammation. These improvements can be observed~     even within the context of persistent obesity. The investigators will implement a~     reduced-calorie, multi-pronged dietary approach for improving insulin sensitivity and~     reducing inflammation in obese subjects with the metabolic syndrome. The active diet will~     include reduced glycemic index foods together with omega-3 fats and polyphenol supplements.~     The primary hypothesis is that the dietary combination of reduced glycemic index foods,~     omega-3 fats and polyphenols will work to reduce insulin resistance and inflammation more~     efficiently than a placebo-controlled, calorie- and macronutrient-matched diet in obese~     subjects with the metabolic syndrome.~   "
119271|NCT02006381|"~     Measuring basal levels of plasma oxytocin in individuals with typical development across~     childhood and adolescence using both extracted and unextracted EIA methods.~   "
119272|NCT02006368|"~     The purpose of this study is to determine the life span and functional characteristics of~     platelets derived from whole blood that has been stored in a refrigerator for up to 21 days.~     Currently, platelets are separated from red cells shortly after donation and stored at room~     temperature for no longer than 5 days. This study is considered experimental because; 1) we~     will be keeping platelets in the original whole blood donor unit in the refrigerator, and 2)~     we will be reinfusing a small portion of that donation back into the study-subject-donor and~     tracking how many of the transfused platelets from that unit circulate in the~     study-subject-donor in the hours and days after transfusion.~   "
119273|NCT02006355|"~     This study aims at comparing continuous local anesthesia and femoral nerve bloc for total~     knee arthroplasty in terms of post-operative recovery.~   "
119274|NCT02006342|"~     To determine if co-administration of subcutaneous (SQ)Insulin glargine in combination with~     intravenous (IV) insulin decreases the time to resolution of ketoacidosis and requirement for~     ICU admission compared to IV insulin with delayed administration of SQ glargine for the~     treatment of diabetic ketoacidosis (DKA).~   "
119275|NCT02006329|"~     Nonalcoholic fatty liver disease (NAFLD) is the most common cause of liver dysfunction~     worldwide. NAFLD may progress to nonalcoholic steatohepatitis (NASH) and in turn to~     cirrhosis. To date, the detailed pathogenic mechanism of NAFLD including steatosis and NASH~     is not fully characterized, although it is regarded as a hepatic manifestation of the~     metabolic syndrome, sometimes it occurs in the absence of a metabolic syndrome. Based on~     conventional models of two-hit and multi- hit hypothesis of NAFLD, the dysregulated lipid~     metabolism and insulin resistance are considered as the first hit of the liver and the~     following second hit or multi-hit likely involves oxidative stress, lipid peroxidation,~     increased inflammatory responses, induced hepatic fibrosis and apoptosis. This emphasizes the~     multi-factorial pathogenesis of NAFLD and the necessity to treat NAFLD with diabetes-like and~     multimodal strategy. Several changes in dietary intake have occurred in the past few years,~     including increased energy intake (24%), and increases in added sugars, flour and cereal~     products, fruit, added fats and total fat intake. The increasing prevalence of NAFLD is~     probably directly affected by the contemporary epidemics of obesity, unhealthy dietary~     pattern, and sedentary lifestyle. Currently, there are two major categories of NAFLD therapy:~     lifestyle interventions and pharmaceutical therapies, lifestyle interventions in terms of~     diet and physical activity are regarded as safe and effective, while pharmaceutical~     interventions showed limited efficacy with unknown safety in the long term ,therefore, the~     first line of treatment is lifestyle modification. Although lifestyle intervention dose~     positively affects NAFLD, it has limitations. Patients adherence to dietary intervention is~     50%, while those who do adhere, find it difficult to maintain after 12 months. ).~     Mediterranean diet has been shown to be effective in reducing NAFLD, liver steatosis and~     improve insulin sensitivity. Acupuncture has been found as an effective treatment for~     improving quality of life in various medical conditions , including hepatitis . Acupuncture~     combined with life style intervention has been found effective in the treatment of obesity,~     metabolic syndrome in terms of weight, lipid regulation, glucose levels and various markers~     of inflammation. Acupuncture's effect on NAFLD has yet to be studied.~      We suggest that acupuncture combined with life style intervention can be an effective~     treatment for NAFLD.~   "
119276|NCT02006316|"~     The purpose of this study is to evaluate whether clinical varicoceles are associated with~     abnormal semen parameters and whether varicocelectomy could improve the semen parameter in~     patients unrelated with infertility.~   "
119312|NCT02005835|"~     The purpose of this study is to determine if enhanced support for women and their families~     within facilities and/or through community outreach will result in improved retention in the~     continuum of PMTCT care.~   "
119313|NCT02005822|"~     The objective of the trial is to investigate whether early treatment with oral valganciclovir~     of infants with both congenital cytomegalovirus infection and sensorineural hearing loss can~     prevent progression of hearing loss.~   "
119277|NCT02006303|"~     The primary objective is to assess whether prostatic artery embolization has a similar~     efficacy and safety profile as GreenLight PVP in treating patients with urinary retention~     secondary to benign prostate hyperplasia (BPH). Subjects who consent will be randomized to~     either the Prostate embolization (PAE) arm or to the GreenLight PVP arm.~      The primary endpoint of efficacy of the procedure is measured by the ability of the patient~     to void. The secondary endpoints recorded will include patients' satisfaction measured by~     International Prostate Symptom Score (IPSS), peak flow rate (Qmax) and post-void residual~     urine volume (PVR) and prostate specific antigen (PSA) will be measured at 3, 6, and 12~     months post treatment. Also, reduction in prostate volume is considered by MRI~     preoperatively, 3 months and 12 months.~   "
119278|NCT02006290|"~     The B7441003 study will assess PF-06412562 for motor benefit in Parkinson's disease subjects.~     Safety, tolerability and PK of PF-06412562 in Parkinson's disease subjects will also be~     evaluated.~   "
119279|NCT02006277|"~     This study is intended to evaluate the sensory attributes and estimate the relative~     bioavailability of three prototype oral formulations. Subjects will either taste 75-mg doses~     by swirl and spit (Cohort 1) or will receive five oral single 250-mg doses with a washout~     period of at least 14 days (Cohort 2).~   "
119280|NCT02006264|"~     This prospective, randomized, single-blinded, placebo controlled trial will examine the~     safety and pharmacokinetics (PK) of a polyurethane tenofovir disoproxil fumarate (TDF)~     vaginal ring when used continuously for 14 consecutive days.~      The primary objective is to assess the safety of TDF vaginal rings when used continuously for~     14 days by healthy, HIV-uninfected, sexually abstinent women, as compared with a placebo~     vaginal ring.~   "
119281|NCT02006238|"~     This is a prospective, randomized, double-blind, crossover study. The purpose of this study~     is to determine whether Farabloc fabric is effective in alleviation of hot flash symptoms in~     menopausal women. This study will require all prospective participants to fill out a week of~     Hot Flash Diary to determine eligibility before beginning the study. All prospective~     participants will be assessed for hot flash frequency, hot flash distress and hot flash~     severity according to their perception in the Hot Flash Diary during the experimental period.~   "
119282|NCT02006225|"~     Plerixafor has been intensively used in recent years for harvesting autologous stem cells~     from lymphoma and myeloma adult patients. Its use is indicated after failure to harvest with~     GCSF alone. Nevertheless, in the pediatric population its appliance is less well established~     and the indications are less well confirmed .Several disease states and diagnoses may prompt~     the anticipation of difficulties in harvesting stem cells using GCSF only. Such patients may~     benefit utilizing plerixafor in first-line rather than exhausting the stem cell niche with~     GCSF alone and only than go for plerixafor as second-line rescue procedure.~      In this study we propose to examine the applicability and feasibility of harvesting~     autologous stem cells by means of GCSF + plerixafor in first-line measure for pediatric~     patients with specific indications.~   "
119283|NCT02006212|"~     Neurologic complications after cardiac surgery range over a wide spectrum including~     postoperative delirium (PD), postoperative cognitive dysfunction (POCD) and cerebrovascular~     accidents (CVA). The incidence of these neurologic events varies depending on the type of~     surgery and the population studied. The incidence of PD and/or POCD is further influenced by~     the type of the neurologic tests used. Moreover, the timing of these tests seems to influence~     the results. Intraoperative cerebral monitoring is gaining importance in the anesthesia~     field. Recent findings have pointed out that cerebral hypoperfusion on one hand and deep~     levels of anesthesia on the other hand are major sources of adverse neurological outcomes,~     both of which can be detected with different non-invasive cerebral monitors.The present~     investigators are currently using the NeuroSENSE®, a processed electroencephalogram (pEEG)~     monitor together with cerebral near-infrared spectroscopy (NIRS) on a daily basis in every~     cardiac patient.~      This large, prospective, observational study will investigate whether the short- and mid-term~     neurologic outcome of adult patients undergoing cardiac surgery are in line with observations~     made on the basis of the pEEG monitor NeuroSENSE® and cerebral NIRS.~   "
119284|NCT02006199|"~     Hypothesis of this study is that mindfulness meditation would decrease the severity of~     obsessive-compulsive symptoms.~   "
119285|NCT02006186|"~     US children's active commuting to school (ACS; walking or cycling to school), previously~     common (48% in 1969) is now uncommon (13% in 2009). This decline coincided with the obesity~     epidemic, which disproportionately affects low-income and ethnic minority children. Programs~     to increase children's moderate-to-vigorous physical activity (MVPA) and lower obesity and~     related chronic disease risk are necessary. The Bicycle Train is an innovative program in~     which children cycle to and from school led by adults. Bicycle Trains provide another option~     for ACS, especially for children who live too far to walk to school. No randomized controlled~     trials (RCT) have evaluated Bicycle Trains and children's ACS or MVPA. Increasing the percent~     of children who cycle to school is sub-objective PA-14 of US Healthy People 2020.~      The Primary Goals are to (a) conduct a pilot cluster RCT of a Bicycle Train program among~     low-income, ethnic minority 4th and 5th grade children and (b) collect concurrent~     accelerometer and GPS data and validate algorithms to identify and measure physical activity~     intensity and duration for children's cycling compared to heart rate monitors.~      Our Specific Aims will be to:~      SA1) evaluate among 80 4th and 5th grade ethnic minority children the feasibility of a pilot~     cluster RCT of a Bicycle Train program for (a) recruiting participants for a planned~     full-scale cluster RCT (b) promoting their participation, and (c) identifying~     barriers/facilitators to their participation; and SA2) validate algorithms examining~     concurrent accelerometry and global positioning system (GPS) data to identify and measure~     children's physical activity intensity and duration while cycling compared to the criterion~     standards of heart rate monitoring and direct observation~      Feasibility Criteria (FC): As recommended for pilot studies, in which the main goal is to~     test feasibility of a research protocol, a fully powered R01-funded cluster RCT will be~     determined to be feasible if:~      FC 1) We successfully recruit 80 low-income 4th and 5th grade children for the pilot Bicycle~     Train cluster RCT FC 2) The intervention children participate in the Bicycle Train program on~     average twice/week or more FC 3) Algorithms analyzing concurrent GPS and accelerometer data~     have high agreement, i.e. >90% agreement, with heart rate data/direct observation in~     distinguishing children's cycling-related physical activity duration and intensity from other~     physical activities and riding in a motor vehicle~   "
119314|NCT02005809|"~     Gastroenterologists often follow up second look endoscopy after endoscopic submucosal~     dissection(ESD) of gastric neoplasms because they want to prevent bleeding of procedure~     sites. But Goto suggested in his retrospective analysis that a second-look endoscopy after~     endoscopic submucosal dissection for gastric epithelial neoplasm may be unnecessary. So, the~     investigators try to identify the hypothesis prospectively in this study.~   "
119315|NCT02005796|"~     In this study, the postprandial glycemia and insulinemia caused by boiled potato with~     blue-fleshed or yellow-fleshed tubers, or a gel prepared with bilberries and potato starch,~     is studied in healthy males. Additionally, the appearance and metabolism of the flavonoids~     and their metabolites is studied in plasma and urine.~   "
139935|NCT01735721|"~     The aim of this study was the radiographic and clinical comparison of Algipore with~     decalcified freeze-dried bone allograft (DFDBA) in the open maxillary sinus lift technique~     using piezoelectric instruments.~   "
119286|NCT02006173|"~     This clinical trial is a double-blind, randomized, within-subject controlled, 2-armed,~     single-center study sponsored by SciVision Biotech Inc. and approved by National Taiwan~     University Hospital Research Ethics Committee. The aim of this post-marketing study is to~     evaluate the safety and efficacy of Hya-Dermis mixed with lidocaine, as well as the~     effectiveness of corrections of Hya-Dermis mixed with lidocaine. Accounting for potential~     loss to follow-up, the minimum enrollment was statistically determined to be 40 patients.~      The study was estimated to be held one and half year including a 0-2 weeks screening period,~     a day of treatment, and follow-up at month 1, 3, 6, 9, 12. Patient informed consent forms~     will be obtained before the treatment. A pre-treatment photograph, nasolabial folds (NLF)~     severity scale scores, and individual aesthetic satisfaction will be the baseline. Two sets~     of randomized numbers are used, patient numbers and treatment numbers. Participants with odd~     patient numbers will be assigned to nasolabial group and those with even patient numbers will~     be assigned to nasolabial&cheekbone group. Participants receive experiment treatment~     (Hya-Dermis mixed with lidocaine) in one side and control treatment (Hya-Dermis mixed with~     normal saline) in the other side of the face randomly depending on the treatment numbers.~     Both physicians and participants are only blind to the treatment assignment. 30 minutes after~     the injection, a post-photograph will be used to evaluate NLF severity scale scores and~     global aesthetic improvement scale (GAIS) by physicians. A questionnaire including the Visual~     Analog Scale (VAS) of pain during the treatment and individual aesthetic satisfaction will be~     collected from patients. The effectiveness analyses compare NLF severity scale scores and~     GAIS based on photograph records from physicians, as well as participant questionnaires for~     each group on every visit. The safety assessment evaluates any recorded adverse events~     following the device treatment.~   "
119287|NCT02006160|"~     Cognitive impairment is common in multiple sclerosis (MS) and has devastating impact on~     functional activities. There is great demand for medications that will enhance cognitive~     capacity in MS patients. To date, there is no evidence for improvement in cognition following~     treatment with aminopyridines, but the few studies on the topic included neuropsychological~     (NP) tests as secondary or tertiary outcomes, and were methodologically flawed. Dalfampridine~     may enhance cognition by direct pharmacological mechanisms, and should have effects on motor~     outcomes as in prior studies. By combining cognition and motor outcomes in the proposed~     study, the investigators will evaluate if the same patients with positive effects show~     beneficial responses on motor outcomes including physical activity and if such motor outcomes~     mediate and/or moderate cognitive improvements with dalfampridine~   "
119288|NCT02006147|"~     The purpose of this study is to determine whether ProDex provides an ideal, safe,~     long-acting, dexamethasone sodium phosphate (DSP) delivery system for the treatment of~     macular edema due to retinal vein occlusion (RVO).~   "
119289|NCT02006134|"~     Childhood chronic vasculitis describes a group of rare life-threatening diseases that have in~     common inflammation of blood vessels in vital organs such as kidneys, lungs and brain. Most~     knowledge about them comes from adult patients. Severe disease requires aggressive~     life-saving treatments with steroids and some cancer drugs which can themselves cause damage,~     and increase risks of cancer and severe infections. Conversely, milder disease can be treated~     with less toxic drugs. Different classification and scoring tools are used to define the~     types and severity of vasculitis and to measure damage caused by disease or drugs. These in~     turn help direct how aggressively to treat a patient and to measure outcome. None of these~     tools however have been assessed in children and the best balance of disease and treatment~     risks against outcome for children is not known. Although causes of these diseases in~     children and adults are probably the same, the effects of the disease and the response (good~     and bad) to drugs will differ in growing children. Because specialists may see only one new~     child with vasculitis each year, obtaining enough information to learn about childhood~     vasculitis requires cooperation. We will use an international web-based registry to which~     doctors from 50 or more centers can contribute patient data. We will determine the features~     which help better classify and diagnose children compared to adults. Through the web we will~     collect and analyze information on patients similarly classified and scored so that most~     successful treatments can be identified. Children with vasculitis are less likely to have~     diseases associated with aging, alcohol and smoking etc., and therefore may be a better group~     in whom to study the underlying biology of vasculitis. We will use this opportunity and~     collect spit, blood and tissue from registry patients for laboratory study with an aim to~     find biomarkers to better classify, define and direct optimal treatment and outcomes.~   "
119290|NCT02006121|"~     The main purpose of this study is to investigate the efficacy of apomorphine subcutaneous~     infusion compared to placebo in advanced Parkinson's Disease patients.~      The secondary purpose of this study is to investigate the safety and tolerability of~     apomorphine subcutaneous therapy.~   "
119291|NCT02006108|"~     The goal of this study is to develop a non-invasive imaging test for in vivo detection of~     kidney transplant rejection. The hypotheses are that 1) Ferumoxytol-MRI can generate accurate~     estimates of tissue iron concentrations and tissue macrophages. 2) The signal given by a~     renal allograft on Ferumoxytol-MRI demonstrates significant differences between rejected and~     non-rejected transplants.~   "
119292|NCT02006095|"~     Carotid revascularization can significantly reduce the risk of stroke in patients with severe~     carotid stenosis; however, it has been associated with cognitive decline in 25% of the older~     adults who undergo the procedure. Characterizing risk factors for cognitive decline following~     carotid interventions and individualizing treatment strategy based on those risks can~     minimize procedure-associated cognitive dysfunction. Neuroimaging techniques that~     characterize white matter integrity and regional hypoperfusion have the potential to provide~     sensitive brain structure indicators that may be associated with memory decline following~     revascularization procedures. In this protocol, we hope to determine how cerebral blood flow~     and baseline white matter abnormality in the vulnerable region modify the frequency and~     cognitive effect of microembolization following carotid revascularization procedures.~   "
119293|NCT02006082|"~     The purpose of this study was to evaluate the effects of telemedicine video-consultation~     (TVC) on the frequency of hospital re-admissions during 12 months follow-up after TVC among~     patients with chronic obstructive pulmonary disease (COPD). Our secondary aims were to assess~     the impact of TVC on the length of recurrent hospital stays and time to re-admission within~     12 months follow-up after TVC. We also wanted to evaluate the patient satisfaction related to~     TVC.~   "
119294|NCT02006069|"~     The purpose of this Clinical investigation is to assess the impact of the Multi Point Pacing~     (MPP) feature at 12 months in the treatment of patients not responding to standard Cardiac~     Resynchronization Therapy (CRT) after 6 months.~   "
119316|NCT02005783|"~     To evaluate EC/TC (epirubicin and cyclophosphomide or docetaxel and cyclophosphomide) with~     EC/TC plus DBD (Danggui Buxue Decoction) in adjuvant treatment of breast cancer patients. The~     aim is to evaluate whether DBD can decrease the incidence of grade 3/4 neutropenia induced by~     EC/TC regimen during chemotherapy.~   "
119317|NCT02005770|"~     Serious concern about the role of anesthesia in tumor recurrence has considerably risen over~     years, but the lack of surrogate markers for tumor spreading made trials addressing this~     issue difficult to realize. In breast cancer patients CTC positivity has been recently~     recognized as an independent prognostic factor. In this respect, we postulated that in a~     first step changes in the number of CTC after general anesthesia would help to determine the~     effect of anesthesia on this tumor marker.~   "
119318|NCT02005757|"~     The purpose of this study is to access the efficacy and safety of Mizoribine 150mg qid and~     50mg tid in active rheumatoid arthritis patients unsuccessfully treated with~     disease-modifying antirheumatic drug.~   "
119295|NCT02006056|"~     The primary objective of the study is to examine the efficacy of Ondissolve for the~     prevention/rescue of Acute and Delayed Phase radiation induced nausea and vomiting (RINV) in~     patients undergoing single or multiple fraction, emetogenic palliative radiation therapy for~     painful bone metastases. The study population will be 30 patients seen in the RRRP at the~     Sunnybrook Odette Cancer Centre receiving palliative radiation therapy considered emetogenic~     for bone metastases. Patients will take the study medication (Ondissolve 8 mg) twice on each~     day of radiation therapy, at least one hour prior to treatment and repeat approximately 6-8~     hours later the same day. Patients undergoing multiple fraction radiation therapy will take~     Ondissolve on weekends or holidays in between treatment. Secondary objectives include to~     evaluate key secondary endpoints related to RINV, and to investigate the ease and length of~     administration of protocol medicine. We hypothesize that Ondissolve will be effective in the~     prophylaxis of RINV, and the ease of use and administration will provide an appropriate~     delivery method for those unable to tolerate the oral form of ondansetron.~   "
119296|NCT02006043|"~     evaluate Erlotinib efficacy and safety as the 2nd/3rd line treatment in advanced or recurrent~     NSCLC with EGFR wild type and without c-met expression~   "
119297|NCT02006030|"~     Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from~     microbes that degrade arginine. ADI has been formulated with polyethylene glycol and has been~     used to treat patients that have cancers that require arginine. In this study, the~     investigators will evaluate the response rate, as determined by the revised International~     Working Group recommendations.~   "
119298|NCT02006017|"~     The use of the best evidence available for decision-making is nowadays an undisputed goal in~     health care. However, this is not always achieved in the context of clinical practice. Two of~     the potential solutions to bridge the gap between evidence and the clinical practice are the~     evidence summaries and the evidence based recommendations. However, it is not clear, and~     frequently controversial, to what extent clinicians consider helpful recommendations~     accompanying evidence summaries. The investigators will explore this question by conducting a~     study where clinicians will be randomized to receive a clinical scenario accompanied by an~     evidence summary plus a recommendation and a second clinical scenario accompanied by only for~     an evidence summary (group A) or vice versa (Group B). The outcome will be clinicians'~     preferences.~   "
119299|NCT02006004|"~     Epidemiologic and retrospective multicenter registry of all patients diagnosed with de novo~     or secondary AML in the PETHEMA Group institutions. This study is a non-interventional~     research regarding diagnosis and therapeutic approach~   "
119300|NCT02005991|"~     This study will see how PF-05212377, an experimental drug to treat symptoms from Alzheimer's~     Disease, distributes in the brain after one dose of PF-05212377 is administered orally to~     healthy volunteer subjects. The study will also evaluate the safety and tolerability of~     PF-05212377 in these subjects and will measure the level of PF-05212377 in the blood.~   "
119301|NCT02005978|"~     Acromegaly is caused by increased production of growth hormone (GH) from a usually benign~     pituitary tumor. The disease causes a number of complications including disturbances in~     glucose metabolism and about 25% of the patients develop diabetes. Most patients are cured~     upon surgery alone, but many require additional medical treatment, and in rare cases~     radiotherapy. A disadvantage of radiotherapy is a risk of radiation damage to nearby areas~     such as the hypothalamus. The true extent of irradiation induced hypothalamic dysfunction,~     however, remains uncertain.~      Data have shown significant improvement and often normalization of glucose metabolism upon~     surgical cure from acromegaly, whereas data suggest that such improvement is less likely in~     patients receiving additional radiotherapy.~      The hypothalamus is part of the so-called 'gut-brain axis', where gastrointestinal hormones~     through interaction with the hypothalamus plays a significant role in the regulation of~     appetite and glucose metabolism. Incretins are the most prominent gastrointestinal hormones~     involved, with the incretin-effect referring to food-induced insulin secretion, which in~     healthy subjects is responsible for up to 70% of the insulin response after oral glucose~     intake. The investigators hypothesize that radiation conditional influence of the~     hypothalamus may compromise the gut-brain activity and thereby affect the incretin-effect and~     gastrointestinal-mediated glucose disposal (GIGD; i.e. sum of all gastrointestinal-derived~     factors that contribute to glucose metabolism) in patients with acromegaly. The aim of the~     study is to investigate the long term effect of surgery with or without additional~     fractionated radiation therapy on glucose metabolism as assessed by incretin-effect and GIGD~     in acromegaly, in order to identify possible associations with treatment modality.~      The study population include 24 acromegalic patients who have previously received (N=12) or~     did not receive (N=12) pituitary irradiation as part of their treatment, and 12 matched~     healthy controls.~   "
119302|NCT02005965|"~     The MERCURY Study demonstrated the accuracy, feasibility and reproducibility of Magnetic~     Resonance Imaging (MRI) to stage rectal cancer in a prospective, multidisciplinary,~     multi-centre study. However, there were differences in patient outcome, dependent upon the~     position of the tumour in the rectum and its height above the anal verge. Whilst the outcome~     was excellent for patients who underwent an anterior resection, the outcome, based upon~     margin involvement and quality of the specimen, was poor for patients who underwent an~     abdomino-perineal excision for low rectal cancer.~      It is proposed that accurate MRI staging pre-operatively will allow the correct patients to~     receive neo-adjuvant chemoradiotherapy (CRT), and also pre-warn the surgeons if the resection~     margins appear threatened so that the operation can be modified to take this into account.~     The primary aims of the Low Rectal Cancer Study (MERCURY II) are to assess the rate of CRM~     positivity rate in low rectal cancer and to assess the difference in global quality of life~     at two years post surgery in patients according to plane of surgery with or without sphincter~     preservation.~   "
119303|NCT02005952|"~     Still not well resolved access, execution and interpretation of spirometry in primary care~     medicine. This seriously affects the quality of care of chronic respiratory diseases.~      OBJECTIVE: To compare the effectiveness of two methods for quality control in performing~     spirometry in primary care teams (EAP) participating in the Healthcare Process Chronic~     Obstructive Pulmonary Disease (COPD ) (multidisciplinary program between primary care~     medicine and hospital for improved care COPD).~      METHODS: Randomized controlled trial of clusters of EAP participants ( n = 17 ). The quality~     control of spirometry in each EAP randomize into three branches:~        1. Supervision from the pulmonary function laboratory of the Hospital ; computer.~        2. Program incorporated into automated spirometer.~        3. Spirometric usual practice (control group without any support on the quality ).~          Spirometry EAP participants include year follow-up study . All sites use the same model~          spirometer and have received the same previous training . In a 2nd phase results~          implementing the most effective method shown in the 1st phase was studied.~      EXPECTED RESULTS : The method for quality control more effective to obtain and maintain the~     quality spirometry.~      POTENTIAL IMPACT EXPECTED : performing spirometry quality in the EAP , improve early~     detection (secondary prevention ) , the diagnosis of the severity and developmental control~     of COPD.~   "
119304|NCT02005939|"~     Biophenols can act as powerful antioxidants. Pomegranate (Punica granatum) provides a rich~     and varied source of biophenols with the most abundant being ellagitannins, tannins,~     anthocyanins, ellagic and gallic acids. Interest in antioxidant polyphenol-rich pomegranate~     products has increased in recent years with growing reports of potential health benefits.~     Pomegranate biophenols have been noted to lower systolic blood pressure, salivary stress~     hormones and increase insulin sensitivity in previous trials involving participants who have~     cardiovascular disease, but few studies have been conducted recruiting healthy volunteers,~     and those have made use of pomegranate juice rather than extract.~      The aim of this parallel study is to investigate the effect of pomegranate extract~     supplementation on blood pressure, lipid profiles, salivary stress hormones, insulin~     sensitivity, body composition and the perceived quality of life in healthy volunteers over 4~     weeks.~      It hypothesizes that consumption of biophenol-rich Pomegranate extract could increase insulin~     sensitivity and perceived quality of life while decreasing blood pressure, body measurements~     and stress hormones in healthy individuals.~   "
119305|NCT02005926|"~     -  This is a phase II, prospective, single-center, non-randomized, non-controlled study.~        -  Sentinel lymph node biopsy (SNB) is a standard staging procedure in early breast cancer.~          The potentially increasing false negative rate of SNB was concerned if the sonographic~          abnormal node was not excised. The aim of this study was to evaluate the accuracy of SNB~          in breast cancer with sonographic abnormal axillary lymph nodes.~   "
119306|NCT02005913|"~     The best strategy to prevent colorectal cancer (CRC) death lies in early detection and early~     treatment at the local disease status of tumor. After curative resection of tumor, there are~     about 5~10% of stage I, 20~30% of stage II and 40~50% of stage III patients suffering~     metastasis during subsequent follow-up periods. Although carcinoembryonic antigen (CEA) is~     the most widely used biomarker for postoperative monitoring of recurrence on asymptomatic~     patients, it is difficult to use CEA as biological marker to identify the population with~     high recurrent risk in patients with early-stage cancer because lower than half of patients~     with early-stage cancer do not have CEA elevation. For improving the survival of patients~     with early-stage CRC, we need effort to search more useful biological markers to predict the~     risk of tumor recurrence and to select out patients with high recurrent risk to receive~     preventive adjuvant therapy.~      Circulating tumor cells (CTCs) in the blood play an essential role in cancer metastasis.~     Hence, the detection of CTCs and subsequent analysis can potentially revolutionize the cancer~     care ranging from screening, diagnosis, monitoring, to drug selection and so on. In the past~     decade, many methods using magnetic beads (CellSearch), filtration (RareCelletc), or flow~     cytometry have been developed but all of them have the shortcomings from low sensitivity, low~     purity, to unable to retrieve cells for downstream molecular analysis and cell culture.~     Recently, a biomimetic affinity based microfluidic platform has overcome abovementioned~     technical challenges. Importantly, by using only 2 ml of peripheral blood, Sinica's team has~     shown that the enumeration of CTCs increases with the CRC disease progression, where the mean~     CTC counts are 3, 15, 29 and 60 per ml for the stages I, II, III and IV, respectively. The~     results imply that monitoring CTC enumeration serially may serve as a prediction marker to~     identify the CRC patients with high probability of recurrence. The aims of this study are~     toestablishing CTC platform standard operation protocol (SOP) that leads to certification of~     ISO 13485 and to establish CTC criteria and evaluate its prediction power of early detection~     of colorectal cancer recurrence.~   "
119307|NCT02005900|"~     Highly active antiretroviral therapy (HAART) is able to cause lipid metabolism and glucose~     homeostasis alterations, which are associated to the redistribution of body fat. Alterations~     in lipid and carbohydrate metabolism contribute to the development of a highly atherogenic~     profile, which together with altered fibrinolysis markers and increased presence of~     proinflammatory cytokines in blood (especially tumor necrosis factor alpha) that comes~     associated to the success of HAART can cause the development of accelerated atherosclerosis.~     Docosahexaenoic acid (DHA) is a polyunsaturated fatty acid that has demonstrated its ability~     to reduce triglyceride levels; modify cholesterol fractions and increase the size of LDL~     particles thereby configuring less atherogenic plasma profile. Additionally, administration~     of DHA has shown antiinflammatory and hypotensive activity, which contributes to reduce the~     risk of cardiovascular complications in these patients. At a molecular level, DHA acts as a~     stimulator of the nuclear receptor PPAR-gamma, which has been described to induce an increase~     in adipocyte differentiation. Furthermore, the anti-inflammatory effects induced by DHA, can~     decrease the elevated levels of TNF-alpha, which has been implicated in the pathogenesis of~     body fat redistribution in HIV infected patients undergoing HAART. Therefore, the hypothesis~     of this project is that DHA will be able to produce lipid-lowering, anti-inflammatory,~     hypotensive and profibrinolytic effects, which all together should improve atherogenic~     profile of patients with HIV-1 infection receiving HAART. In addition, their proprieties as~     PPAR agonist can improve the redistribution of body fat present in many of these patients.~     The study of the activity of DHA on dendritic cells and monocytes should indicate the absence~     of immunosuppressive effect of DHA in the context of HIV-1 infection.~      In summary, DHA is a natural product, from the omega 3 polyunsaturated fatty acids, the~     therapeutic properties of which have been described in recent years and has shown~     cardio-vascular and metabolic beneficial effects, without recognized side effects. The highly~     purified DHA administration at high doses could be able to reverse, at least partially, lipid~     abnormalities associated with HAART and to exert a beneficial effect on fat redistribution in~     HIV-infected patients treated with HAART. To ensure non deleterious immunological treat in~     these sensitive poly-medicated patients, substantial changes in the functionality of~     dendritic cells and monocytic will be studied.~   "
119308|NCT02005887|"~     The purpose of the this study is to investigate the anti-tumor activity and tolerability of~     the study medications Degarelix and Triptorelin in premenopausal women receiving preoperative~     treatment with Letrozole.~   "
119309|NCT02005874|"~     The purpose of the study is to collect valuable data on the role of controlled humidity,~     temperature, airflow, and visual tasking in altering the tear film protein composition. The~     results from this preliminary study will help to explore the role of tear film markers in~     inflammatory and disease conditions. This can also be extended to understand the role of the~     tear film in protecting the ocular surface when individuals are exposed to low humidity~     environments which may incite discomfort symptoms.~   "
119310|NCT02005861|"~     BACKGROUND Osteochondral lesions are defects of the cartilaginous surface and underlying~     subchondral bone of the talar dome.~      The use of concentrated bone marrow derived cells has been gaining successful results with~     arthroscopic implantation, since it is possible to transplant not only mesenchymal stem cells~     but also accessory cells that support angiogenesis and vasculogenesis by producing several~     growth factors.~      OBJECTIVES Objective of this project is to identify the critical points of the regenerative~     treatment of osteochondral lesions of the ankle, in order to develop a standard and~     predictable procedure able to overcome the drawbacks of the previous techniques.~      METHODS Our program is to evaluate and follow 140 new patients with focal osteochondral~     lesion of the talus. The surgical procedure will be executed as following: the day before the~     surgery the platelet gel will be produced. The day of the surgery bone marrow will be~     aspirate from the posterior iliac crest and concentrated directly in the operating room by~     centrifugation, in order to obtain 6 mL of concentrate containing nucleated cells.~      Then a standard ankle arthroscopy will be performed. The scaffold will be loaded with 2 ml of~     bone marrow concentrate and cut into an appropriate shape.~      After the scaffold implantation platelet gel will be sprayed on the top of implant, in order~     to provide extra growth factors and to improve the stability of the implant.~      All patients will be examined clinically preoperatively, at 3, 6, 12, 24 and 36 months and at~     maximum follow-up. Different score scales will be used to objectivate the clinical results~     (AOFAS, SF-36, VAS). X-rays and MRI scan will be also taken preoperatively, and MRI will be~     executed at 12, 24 and 36 months of follow-up. In particular, a new qualitative MRI called T2~     mapping will be performed at 24 months.~      EXPECTED RESULTS We expect to highlight the effectiveness of the arthroscopic bone marrow~     derived cells (BMDCs) transplantation in a long term follow up study, with particular~     attention to identify the patient population that can gain the maximum benefit from this~     treatment, avoiding expensive and unnecessary procedures that too often are performed.~   "
119319|NCT02005744|"~     The purpose of this study is to evaluate pharmacokinetics of CKD-501 in patients with~     impaired hepatic function compared with normal hepatic function.~   "
119322|NCT02005705|"~     Patients presenting to the emergency room with upper gastrointestinal bleeding and a Glasgow~     Blatchford score of zero will be randomly assigned to further care in the inpatient vs.~     outpatient setting. The hypothesis of this study is that patients who are managed as~     outpatients will require interventions at a rate not higher than those managed as inpatients~     and will have lower direct healthcare costs.~   "
119323|NCT02005692|"~     The study is designed to test the DynaSense system, which is a patient movement and~     orientation monitoring system. The study is intended to determine that:~        -  the DynaSense system identifies patients that are not turning adequately on their own~          and therefore require caregiver-assisted turns.~        -  the DynaSense system identifies patients that are turning adequately on their own and~          therefore do not require a caregiver-assisted turn.~        -  the DynaSense system helps ensure compliance with an institution's established patient~          turning protocol.~   "
119324|NCT02005679|"~     In France the prevalence of pre-lingual deafness is between 1 and 1.4 per 1000 habitants, and~     according to very conservative estimates, about 44 000 deaf persons use the sign language.~     Additionally, the prevalence of dementia in France is close to 1% (850 000 dements for a~     total population of 65 millions). The prevalence of dementia in pre-lingual deaf adults has~     also been described and is between 1 and 1.4 /100 000 habitants.~      The Mini Mental State Examination (MMSE) of Folstein is a test recommended to perform the~     cognitive evaluation for the detection of mental disorders including dementia, and a~     consensual French version exists prepared by GRECO (Group of Research and Cognitive~     Assessments). However, to date, there are no simple, rapid and validated screening tests to~     study cognitive disorders in deaf persons who use the sign language. The only tests available~     allow a late diagnosis avoiding an optimal treatment of the patients.~   "
119325|NCT02005666|"~     This is an Randomized, Double-blind, Multicentric, Parallel-group, Active and Placebo~     Controlled, Three Arm Clinical Study.~      The main objective is to evaluate bioequivalence of Test formulation (Clindamycin Phosphate~     1.2%/Benzoyl peroxide 5% gel) of Cadila Healthcare with Reference formulation (DUAC® Gel of~     Stiefel Laboratories)in the ratio of 2:2:1 of Test drug, Reference drug and Placebo~     respectively.~      Total study duration will be for a period of 78 days which includes treatment duration of 77~     days.~      850 subjects will be enrolled (randomized)as per the inclusion and exclusion criteria~     mentioned in the protocol.~   "
119326|NCT02005653|"~     Diethylcarbamazine (DEC) essentially a micro-filaricidal drug is given for 12 days as~     standard treatment for the clearance of W. bancrofti infection. It takes about one year for~     the individuals to completely clear the microfilaria from the blood. It takes another two to~     four years to clear the antigen. The aim of the present study is to shorten the time taken~     for clearing the Mf and antigen from the blood either by co-administration or sequential~     administration of a macrofilaricidal drug, Albendazole or doxycycline. This study is a~     randomized, double blind, controlled clinical trial to study the efficacy of these drug~     combinations in complete clearance the Mf and antigen from the blood in shorter span of 180~     days and 365 days respectively.~   "
119327|NCT02005640|"~     The objective of this study is to evaluate the effect of annular sizing strategy (MDCT versus~     TEE) in transcatheter aortic valve implantation on the prevalence and severity of~     paravalvular regurgitation.~   "
119328|NCT02005627|"~     About 45 million people in Europe have allergic rhinitis (hay fever) - inflammation of the~     nasal passages causing sneezing, runny nose, nasal congestion, itching and tearing of the~     eyes. In the United Kingdom (UK), seasonal hay fever due to grass pollen allergy accounts for~     approximately 7 times more doctors' appointments than asthma. The standard treatment for hay~     fever consists of treating the symptoms with a nasal spray and an antihistamine. However, in~     a survey taken in a UK general practice less than 40% of patients with hay fever reported~     good symptom control with this standard treatment. For those patients with hay fever whose~     symptoms are not well controlled by treatment with antihistamines and nasal sprays,~     subcutaneous immunotherapy (SCIT) - (monthly injections of a grass allergen extract for a~     period of 3-5 years) is an effective alternative, and is approved in the UK on a named~     patient basis. More recently, allergen immunotherapy tablets (AITs) have been developed,~     including grass pollen allergen tablets. These have been shown to be highly effective in the~     treatment of hay fever, with the additional benefit of being convenient for patients, given~     that they may be taken at home. Grazax® (manufactured by Allergologisk Laboratorium København~     (ALK)-Abello, Denmark) has UK and European Union (EU) license for use in the treatment of~     troublesome grass pollen induced hay fever. The aim of this research is to investigate the~     effects of the AIT treatment on the immune system over time - which changes are taking place~     and when in the course of treatment. This will provide insight into the complexities of the~     development of allergen-specific immune tolerance - how harmful allergic responses against~     innocuous substances such as grass pollen can be overridden.~   "
119329|NCT02005614|"~     The purpose of this study is to collect prospective data for use as a comparator for future~     subsequent studies attempting to increase the efficacy or reduce the toxicity of gamma knife~     radiosurgery.~   "
119330|NCT02005601|"~     We are investigating the impact of duloxetine (Cymbalta), a serotonin and norepinephrine~     reuptake inhibitor, on pain after total knee arthroplasty (TKA). Specifically, the~     investigators will determine whether duloxetine, 60 mg daily for 2 weeks, reduces pain scores~     2 weeks after TKA.~   "
119331|NCT02005588|"~     Iron deficiency anemia is a very common problem accompanying pregnancy. in this study, the~     investigators are going to compare the efficacy and tolerability of two preparations of oral~     iron in treatment of iron deficiency anemia with pregnancy.~   "
119332|NCT02005575|"~     The proposed study is a randomized, double-blinded, non-placebo-controlled evaluation of the~     effect of the addition of dexamethasone to intraoperative intercostal nerve block bupivicaine~     solutions on the duration of pain relief and post operative pulmonary function.~   "
119333|NCT02005562|"~     This study will compare the incidence of acute clinical or subclinical rejection between~     immunosuppression with CellCept at a starting dose of 3mg po daily with therapeutic drug~     monitoring and standard immunosuppression with CellCept and a fixed dose of 2g po daily, in~     kidney transplant recipients receiving induction by anti-IRL2, cyclosporine therapy, and~     early discontinuation of steroids. Patients will be randomized to one of the two treatment~     arms. The anticipated time on study treatment is 52 weeks.~   "
119335|NCT02005536|"~     The aim of the study is to assess the immunogenicity of SP059 (IMOVAX POLIO®: Inactive~     Poliovirus Vaccine) vaccine against poliovirus and safety after fifth dose.~      Primary Objective:~        -  To investigate the booster vaccine response rate against poliovirus types 1, 2 and 3 one~          month following the vaccination dose with SP059 as 2nd booster~      Secondary Objectives:~        -  To investigate seroprotection rates (percentage of subjects presenting poliovirus~          neutralizing antibody titers above 1:8 (1/dil.) at pre- and post-booster time points,~          Geometric mean titers (GMT) at pre- and post-booster time points and geometric mean of~          individual titer ratio (GMTR).~        -  To investigate the safety after dosing of SP059 as 2nd booster.~   "
119336|NCT02005523|"~     The purpose of this study is to see if use of RNS60 during hip labral repair surgery~     decreases pain and improves functional capacity post-operation.~   "
119337|NCT02005510|"~     The purpose of this trial is to determine whether mailing in-home human papillomavirus (HPV)~     screening kits is effective in increasing uptake of cervical cancer screening and early~     detection and treatment of cervical neoplasia in underscreened women.~   "
119338|NCT02005497|"~     The proposed project will answer key questions about implementing evidence-based health~     promotion interventions at small and low-wage worksites. Small, low-wage worksites will be~     randomized to receive HealthLinks (a free American Cancer Society program to disseminate~     evidence-based interventions), HealthLinks+ (which will include creating worksite wellness~     committees as part of the program), or to serve in a delayed control group. This approach~     will identify successful strategies for implementing evidence-based interventions at low-wage~     worksites to improve workers' cancer screening, healthy eating, physical activity, and~     tobacco cessation.~   "
119339|NCT02005484|"~     This study will evaluate the efficacy and safety of Herceptin in patients with metastatic or~     advanced gastric cancer with disease progression during platinum-based or~     5-fluoropyrimidine-based chemotherapy. The anticipated time on study treatment is until~     disease progression.~   "
119340|NCT02005471|"~     The purpose of this open-label, multicenter, randomized, Phase III study is to evaluate the~     benefit of venetoclax in combination with rituximab compared with bendamustine in combination~     with rituximab in participants with relapsed or refractory CLL. Participants will be randomly~     assigned in 1:1 ratio to receive either venetoclax + rituximab (Arm A) or bendamustine +~     rituximab (Arm B).~   "
119341|NCT02005458|"~     This study is to examine which dose of YPEG-rhG-CSF, once-per-cycle, has similar efficacy and~     safety, comparing to PEG-rhG-CSF, once-per-cycle, in chemotherapy-induced neutropenia~   "
119342|NCT02005445|"~     This is a randomized clinical trial in U.S. Veterans to evaluate the impact of treatment for~     obstructive sleep apnea (OSA) on the effectiveness of cardiac rehabilitation, including~     impact on exercise capacity, disability, and quality of life.~   "
119343|NCT02005432|"~     Objectives:~      Primary objective:~      To evaluate the effects on retinal morphophysiology of full scatter single target panretinal~     photocoagulation (PRP) versus full scatter multiple target panretinal photocoagulation (both~     combined with intravitreous injections of ranibizumab) versus intravitreous ranibizumab (IVR)~     alone in patients with proliferative diabetic retinopathy (PDR).~      Primary outcome:~      The primary endpoint for this study is the mean change in the total area of active retinal~     neovessels, as measured by fluorescein angiography leakage area, in mm2, from baseline to~     week 48.~      Secondary objectives:~        -  To assess the mean changes in best corrected visual acuity (BCVA), the mean changes in~          central subfield foveal thickness (CSFT), the mean changes in wave B amplitude and~          oscillatory potentials on a full-field electroretinogram (ERG), and the mean changes on~          the peripheral visual field by static perimetry (30:2 strategy), from baseline to week~          48.~        -  To assess the incidence of adverse events during the study.~      Strategic goal:~      In the era of anti-VEGF treatment for retinal neovascularization 1, 2, 3, 4 , it is time to~     determine what would be the best association of PRP + anti-VEGF for proliferative diabetic~     retinopathy (PDR), or still, if just intravitreal anti-VEGF treatment would be even better~     regarding morphologic (new vessels area and CSFT) and functional parameters (BCVA, ERG~     response and visual field).~   "
119344|NCT02005419|"~     Pancreatic cancer represents the most lethal of the common malignancies with a 5-year~     survival rate of less than 5%. For patients who are eligible for potentially curative~     resection, despite mortality and morbidity rates after surgery have improved, the recurrence~     rate is up to 85% within 2 years. Data from clinical trials indicate that adjuvant~     chemotherapy enhances 5-year survival to ~25% for patients who have undergone surgery to~     remove their tumor; and gemcitabine is the standard regimen of chemotherapy. Metformin is the~     first-line treatment for type 2 diabetes mellitus. Literatures reported that metformin might~     inhibit tumor growth by blocking some enzymes needed for cell growth. Some retrospective~     studies have revealed that diabetic patients taking metformin were less likely to develop~     pancreatic cancer. Additionally, pancreatic cancer patients treated with metformin showed a~     better survival than those without metformin. In this study, the researchers intend to~     investigate the activity and safety of the combination of gemcitabine and metformin in~     treating patients with pancreatic cancer that have removed by surgery.~   "
119345|NCT02005406|"~     Testing the efficacy and safety of the WEI Nasal Jet.~   "
119346|NCT02005393|"~     The study is intended to test the image quality of the FICE system to the predicate device,~     Narrow Band Imaging (NBI). The hypothesis is the images are of equal quality.~   "
119347|NCT02005380|"~     The focus of this work is to explore the use of modern mobile technology to enable people~     with Alzheimer's disease to improve their abilities to perform activities of daily living and~     hence to promote independence and participation in social activities. This work also aims at~     reducing the burden on caregivers by increasing the AD patients' sense of competence and~     ability to handle behavior problems.~   "
119348|NCT02005367|"~     A person-centered substance use treatment component, the Natural Recovery Program, was~     developed in a residential substance use treatment setting. The Natural Recovery Program is~     comprised of small group therapy combined with pursuit of hobbies. The study examined~     treatment retention, treatment completion and satisfaction of participants of Natural~     Recovery compared to those who participated in core residential treatment activities alone.~   "
140430|NCT01729208|"~     The purpose of this study is to determine whether a new type of soft contact lens with a~     unique optical design (dual focus) is effective at slowing the progression of myopia~     (near-sightedness) in children.~   "
119349|NCT02005354|"~     The approach of this study will be to answer the question does high-frequency stimulation~     Trans-Cutaneous Electrical Nerve Stimulation (TENS) alleviate the pain experienced during the~     bone marrow sampling procedure in addition to the standard analgesia given (ie. local~     anaesthetic with or without inhaled nitrous oxide).~      Null hypothesis: TENS does not alleviate the pain experienced during the bone marrow sampling~     procedure in addition to the standard analgesia given~   "
119350|NCT02005341|"~     The purpose of this study is to assess lumbar fusion using nanOss Bioactive bone void filler~   "
119351|NCT02005328|"~     The purpose of this study is to evaluate the clinical efficacy, the safety and acceptability~     of three new oral sprays with a reference oral spray in the relief of drug-induced xerostomia~     associated with hyposialia, i.e. dryness of the mouth induced by a decrease of salivation~     (hyposialia) induced by chronic drug intake.~   "
119352|NCT02005315|"~     This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and~     PK of vantictumab when combined with nab-paclitaxel and gemcitabine.~   "
119353|NCT02005302|"~     Multi-center, prospective, randomized, controlled study to verify the clinical effectiveness~     of K / DOQI guidelines. The efficiency and safety of Vitamin D2 and low protein diet~     treatment for prevention and treatment of CKD-MBD and malnutrition in CKD3-5 (ND) patients.~   "
119354|NCT02005289|"~     This phase II trial studies how well anti-cluster of differentiation (CD)19 monoclonal~     antibody MOR00208 and lenalidomide work in treating patients with relapsed, refractory, or~     previously untreated chronic lymphocytic leukemia, small lymphocytic lymphoma, or~     prolymphocytic leukemia. Monoclonal antibodies, such as anti-CD19 monoclonal antibody~     MOR00208, can block cancer growth in different ways. Some block the ability of cancer to grow~     and spread. Others find cancer cells and help kill them or carry cancer-killing substances to~     them. Biological therapies, such as lenalidomide, may stimulate the immune system in~     different ways and stop cancer cells from growing. Giving anti-CD19 monoclonal antibody~     MOR00208 and lenalidomide may kill more cancer cells.~   "
119355|NCT02005276|"~     Employers are increasingly looking for opportunities to motivate sedentary employees to~     become more physically active. Workplace walking programs have had mixed success and~     typically show most improvement among participants that are already fairly active at a~     baseline. The goal of this study is to determine whether a financial incentive program can~     motivate sedentary employees to increase the number of steps they walk per day to meet a~     minimum threshold.~      Our primary outcome measure is the proportion of days a minimum activity of 7000 steps or~     more is achieved. We will assess outcomes each week for 3 months using incentives followed by~     3 months of follow-up without incentives. Secondary outcomes will include the average steps~     walked per day.~   "
119356|NCT02005263|"~     Disease of the fallopian tubes is one of the most common reasons for infertility. The most~     common test, a hysterosalpingogram, tends to be painful,inconvenient, and frequently misses~     concurrent uterine disease. We propose using a less painful technique (through modified~     office hysteroscopy) for tubal assessment that can be performed in the office rather than~     hospital radiology and that uses gold standard technology for identifying coexisting uterine~     conditions.~   "
119357|NCT02005250|"~     The aim to evaluate the bone structure by Dexa-scan, extreme CT and bone markers before and~     one year after treatment for a thyroid functional disorder~   "
119358|NCT02005237|"~     Cognitive dysfunction is frequent in patients with multiple sclerosis (MS) and to date, there~     are no available treatments to improve cognition in this patient population. Some evidence~     from animal studies and small clinical trials suggest that aerobic exercise might~     beneficially affect cognitive function in MS. The aim of this randomized-controlled trial is~     to explore if an aerobic exercise training program can enhance cognition in MS. In addition,~     we will employ neuroimaging markers to determine if exercise alters measures of brain~     structure and function.~      Patients will be randomly assigned to either a 3-months exercise program (bicycle ergometry,~     2-3 session per week) or a waitlist control group. The primary endpoint of the study is a~     test of verbal learning and memory. Secondary endpoints include neuroimaging markers of~     functional and structural connectivity in the brain. We hypothesize that exercise will~     improve verbal learning and memory and beneficially affect measures of brain connectivity.~   "
119359|NCT02005224|"~     Intervention studying the effect of a low-carbohydrate/high-fat (LCHF) diet as well as on~     bout of exercise in combination with either a normal diet or a LCHF diet, in relation to~     glucose metabolism, insulin sensitivity, lipid profile and body composition.~   "
119360|NCT02005211|"~     This study consists of two parts, ie, single dose part with young healthy subjects (Part 1)~     and single and multiple dose part with elderly healthy subjects (Part 2), to assess the~     safety, tolerability, pharmacokinetics and pharmacodynamics of AZD3293 following single and~     multiple ascending dose administration to healthy subjects.~   "
119361|NCT02005198|"~     This study is conducted in the United States of America (USA). The aim of the study is to~     assess the minimal important difference (MID) of the TRIM-AGHD.~   "
119362|NCT02005185|"~     Anesthesia for more than 120 minutes given to children less than 2 years of age without~     coexisting diseases of the central nervous system or the heart cause long-term impairment of~     recognition memory.~   "
119363|NCT02005172|"~     In this study, we will evaluate the diagnostic yield of the new AliveCor device versus a 14~     day event monitor with the use of both devices simultaneously. We will also examine by means~     of a questionnaire the compliance, ease of use and patient satisfaction for each device.~      Hypothesis:~        1. The AliveCor monitor will be non-inferior to the 14 day event monitor with respect to~          diagnosis of the arrhythmia responsible for a patient's symptoms.~        2. The AliveCor monitor will have better compliance and acceptability compared to the 14~          day event monitor, and thus there will be a greater number of days with recordings from~          the AliveCor monitor.~   "
119364|NCT02005159|"~     Provide scientific and validated data to help International Authorities to set susceptible to~     antibiotics cut-off points in bacteremia by Enterobacteriaceae~   "
119365|NCT02005146|"~     Define the patients who lost HBsAg, studying the loss predictive factors and if there was~     suspension of treatment, study the evolution after that~   "
119366|NCT02005133|"~     To assess the use of aflibercept over a 2 year period in VEGF inhibitor naive and prior~     treated wet AMD patients managed in 'real wold' clinic settings.~   "
119367|NCT02005120|"~     Malignant pleural effusion (MPE) is a common complication of advanced non-small cell lung~     cancer (NSCLC). Bevacizumab, a humanized monoclonal antibody against vascular endothelial~     growth factor (VEGF), has been shown to be efficient in suppressing the accumulation of~     pleural fluid. The other widely used treatment for MPE is recombinant human endostatin.~   "
119368|NCT02005107|"~     This study is being conducted to evaluate how the body absorbs and processes the immediate~     release (IR) and sustained release (XR) medication venlafaxine (Effexor®). Subject who are~     1-3 years post gastric bypass or sleeve gastrectomy surgery will be invited to participate.~     Non-surgical controls will also be enrolled based on a matching criteria to post gastric~     bypass subjects. Participants will be asked to complete two 12-hour study days approximately~     11 days apart. This study will enroll up to 30 participants.~   "
119369|NCT02005094|"~     1. To investigate the inflammasome response of inflammatory and resting macrophage derived~          from healthy human participants by stimulation using MAC or MAB bacilli.~        2. To compare the difference of inflammasome response of inflammatory macrophage by MAC/MAB~          bacilli stimulation between MAC/MAB-LD patients and the colonizers.~        3. To study the diagnostic aid from immunological markers in inflammasome response in~          inflammatory macrophage stimulated by MAC/MAB.~   "
119370|NCT02005081|"~     The purpose of this single-center, prospective, randomized study is to determine the fusion~     rates along with the clinical outcomes of commercially available bone graft substitutes~     Actifuse mixed with bone marrow aspirate (BMA) versus autograft mixed with demineralized bone~     matrix (DBM), in subjects who require anterior cervical corpectomy (ACC) spinal fusion in~     patients experiencing cervical spondylotic myelopathy (CSM).~   "
119371|NCT02005068|"~     This is a study to evaluate the efficacy of Ceftaroline in the treatment of bone and joint~     infections.~   "
119372|NCT02005055|"~     This prospective study evaluates the outcome of surgical excision with adjuvant~     high-dose-rate brachytherapy for the treatment of recalcitrant keloids. Main outcomes are~     recurrence rate, scar quality and physical complaints.~   "
119373|NCT02005042|"~     Lack of physical activity is associated with negative health outcomes, including obesity,~     diabetes, and cardiovascular disease. There are calls from NIH and medical organizations to~     integrate the use mobile devices, such as smartphones, to provide e-health interventions to~     patients in their daily life. Referred to as Ecological Momentary Interventions [EMI], these~     innovative mobile methods provide an opportunity for researchers and clinicians to offer~     tailored intervention material to people at specific times and in specific settings when they~     may be most in need of such support. To our knowledge no study has used objective ambulatory~     assessment data to deliver EMI. This preliminary work is to demonstrate the feasibility, and~     test preliminary efficacy, of using a Bluetooth accelerometer to provide real-time feedback~     on a smartphone to increase objectively measured steps (i.e., increase activity). A~     within-person design will be used, including assessment, intervention, and follow-up phases.~     During the assessment phase objective physical activity (using accelerometers) will be~     collected. In the intervention phase participants will also receive real-time feedback~     throughout the day regarding their total steps and personalized step goals. Objectively~     measured steps and disease status measures will be used to evaluate efficacy.~   "
119374|NCT02005029|"~     Gastroparesis (slow stomach emptying) is a common feature of Parkinson's Disease. Levodopa~     (Sinemet), a common medication for Parkinson's Disease, can make gastroparesis worse.~     Gastroparesis effects how the levodopa is absorbed and used by the body. This study will~     explore the possibility of using Erythromycin, a drug commonly used (off label) for~     gastroparesis, along with levodopa to determine if there is improved levodopa absorption and~     motor function.~   "
119375|NCT02005016|"~     This study examines aphasia treatment response among Veterans and non-Veterans living with~     aphasia. It seeks to identify cognitive and neural factors which are predictive of positive~     response to treatment targeting naming impairments in aphasia. It also examines the~     dose-response relationship for naming treatment. More broadly, it seeks to determine who~     aphasia therapy works best for, and how much aphasia therapy is sufficient to achieve~     positive treatment response.~   "
119376|NCT02005003|"~     To examine the cognitive and metabolic effects of a probiotic supplement that is readily and~     already available for purchase in public drug stores. This study is a double-blinded~     randomized cross-over placebo-controlled intervention study. Participants will be randomized~     to receive either the probiotic supplement or the placebo during the first intervention~     period which will last 2 weeks. This will be followed by a washout period, after which they~     will proceed to the second intervention period, also lasting 2 weeks and also followed by a~     washout period.~   "
119377|NCT02004990|"~     The overall goal of this study is to improve the standard of care in treating young children~     who often suffer from chronic caries (dental decay). Current standard of care for children~     under 12 years old includes a dental cleaning and fluoride treatment. Often this dental~     cleaning includes a 'dental prophylaxis' with a pumice based paste delivered by a small~     rubber-like cup that rotates on a slow-speed dental handpiece. The procedure of this dental~     prophylaxis removes the gross levels of plaque around the supragingival tooth surfaces. After~     this prophylaxis, a fluoride treatment is delivered. The National Maternal and Child Oral~     Health Resource Center at Georgetown University has published (Bertness J, Holt K) an~     extensive publication proving that 5% sodium fluoride varnish has become the 'standard of~     care' for fluoride treatment in children. This study includes this fluoride standard of care.~      Prior to the administration of this standard of care fluoride treatment, a separate step of~     cleansing the tooth after the dental prophylaxis is added. This study uses a cleansing~     procedure of 10% povidone iodine (PI) cleansing prior to fluoride varnish (FV) application.~      The primary aims of this study are:~        1. to measure the changes in overall plaque levels after using a 10% povidone iodine (PI)~          cleansing prior to fluoride varnish (FV) application.~        2. to measure the short term changes in the oral microbial ecology of dental plaque after~          10% povidone iodine (PI) cleansing prior to fluoride varnish (FV) application.~   "
119399|NCT02004704|"~     The primary objective of this study is to obtain data regarding the safety of olipudase alfa~     in patients with acid sphingomyelinase deficiency (ASMD) who are exposed to long term~     treatment with olipudase alfa.~      The secondary objectives of this study are to obtain data regarding the efficacy of olipudase~     alfa and to characterize olipudase alfa pharmacodynamics (PD) and pharmacokinetics (PK)~     following long-term administration.~   "
119378|NCT02004977|"~     The goals of this intervention study are to implement best practice strategies to expand and~     promote the school breakfast program and test the impact upon student participation rates~     among a) all 10th and 11th grade students and among a randomly selected cohort of 800~     students b) total diet and body mass index and percent body fat inin 16 rural Minnesota~     school districts.~      School-wide Primary Aim: Improve participation in the school breakfast program among high~     school students. Hypothesis: School-wide school breakfast program participation will be~     higher in the intervention versus comparison group.~   "
119379|NCT02004964|"~     Protocol to screen potential subjects for islet transplantation~   "
119380|NCT02004951|"~     Over the past years, endovascular interventions have become an important part of treatment in~     patients with peripheral arterial disease.1 Indication for endovascular repair of~     femoropopliteal lesions has been considerably enlarged as shown in the TASC classification.1~     Enlargement of endovascular therapy indication was based on patient choice for a less~     invasive technique and evidence based medicine. Consequently, TASC classification of lesions~     has been modified to reflect increased evidence for endovascular treatment of more extensive~     femoropopliteal lesions, and indication for endovascular repair has been enlarged to more~     severe TASC types. In summary, endovascular treatment is indicated for TASC A and B lesions~     which correspond to femoropopliteal lesions ≤15-cm. To treat these lesions, the~     interventionalists have at their disposal a huge tool box. Evaluation of these tools is~     crucial to determine the right treatment strategy to avoid further reinterventions and~     overcosts.~      The objective of the BATTLE trial is to compare a bare metal self expandable nitinol stent~     (Misago RX) versus a paclitaxel eluting stent (Zilver PTX) in the treatment of above-the-knee~     intermediate length femoropopliteal lesions.~      From hospitals in Europe (France, Switzerland) we will randomly assign patients with~     symptomatic atherosclerotic femoropopliteal lesions to be treated either by bare metal stent~     or paclitaxel eluting stent. In total, 186 patients will be randomized (93 per group).~   "
119381|NCT02004938|"~     Project Aims: The purpose of this study is to determine the size of the right internal~     jugular vein (RIJV) in children with normal respiratory physiology during the respiratory~     cycle and evaluate the reliability of those measurements.~      Hypothesis: Ultrasound measurements of internal jugular vein collapse of children can be~     reliably measured in the respiratory cycle.~      Intervention: We will ensure that the patient is not having any respiratory symptoms or signs~     of dehydration. A clinical asthma score will be assigned using the Modified Woods pulmonary~     index scoring system. The Gorelick Dehydration Scale with also be calculated.~      Using bedside ultrasonography with the Sonosite Titan ultrasound machine, each measurement~     will be taken with the subject lying in bed with the head of the bed elevated at 45 degrees~     with the subject's head in the neutral position and then turned 45 degrees leftward.~     Measurements of the internal jugular vein at maximal inhalation and exhalation will be~     recorded. Reliability calculations will be assessed.~   "
119382|NCT02004925|"~     Pneumoperitoneum could be due to life threatening conditions and its quickly diagnosis is~     important in the emergency department (ED). Signs and symptoms are non-specific and~     radiography has low accuracy in the acute setting. Computed tomography (CT) is considered the~     gold standard, however it is not a cost-effective option in the vast population of patients~     with abdominal pain. Ultrasonography is able to detect as little as 2 ml of free air, however~     diagnostic accuracy of ultrasonography remains unclear. This study evaluates the accuracy of~     ultrasonography for the diagnosis of pneumoperitoneum, the most accurate abdominal scan and~     the most accurate echographic sign for the detection of free air.~      Methods Consecutive patients presenting to ED for acute abdominal pain and with a diagnosis~     of pneumoperitoneum at CT or at surgery (study group) and a similar number of patients~     without a diagnosis of pneumoperitoneum (control group) undergo abdominal ultrasonography in~     a standardized protocol that include 10 scans for each patient registered on a video of 5~     seconds. The videos are randomly reviewed by 4 sonographers and by 2 physicians with no~     experience in ultrasonography blind to final diagnosis and to all clinical data with the aim~     of detecting for each scan pneumoperitoneum. Accuracy of ultrasonography for the diagnosis of~     pneumoperitoneum will be calculated considering CT or surgery as gold standard. Furthermore~     intra and interobserver agreement and the accuracy of each ultrasonographic sign and scan~     will be calculated.~   "
119383|NCT02004912|"~     Our hypothesis is that an on-site mentoring program for staff at primary health care centers~     in northern Karnataka, will improve the quality of maternal, neonatal and child health care,~     and improve clinical outcomes.~   "
119384|NCT02004899|"~     Epidural analgesia is the most effective form of labor pain relief. Low doses of local~     anesthetic (freezing solutions) in combination with opioids (narcotics) are commonly used as~     epidural solutions to provide pain relief. Low dose local anesthetic solutions with opioids~     for labor have been shown to decrease motor block (leg weakness or temporary paralysis),~     without affecting labor pain relief. However, onset of pain relief can be delayed with these~     low dose solutions. The standard epidural solution used at Victoria Hospital is a low dose of~     local anesthetic called bupivacaine mixed with fentanyl, an opioid, for labor epidural pain~     relief.~      There is some evidence that the addition of more fentanyl to the epidural bolus dose of~     bupivacaine at the start of labor epidural analgesia can speed onset of pain relief. Both~     medications are safe for you and your baby.~      This study will investigate whether the addition of different doses of fentanyl (20 mcg, 50~     mcg and 100 mcg) to the epidural bolus dose speeds onset of pain relief.~      The study hypothesis is that the onset of epidural labor analgesia will be shortest with the~     larger fentanyl epidural bolus.~   "
119385|NCT02004886|"~     This study will assess the safety, tolerability and glucose-lowering efficacy of MK-0893 in~     participants with type 2 diabetes mellitus. The primary hypothesis is that MK-0893 will~     reduce 24-hour weighted mean glucose (WMG) significantly more than placebo.~   "
119386|NCT02004873|"~     The purpose of this clinical study is to evaluate the safety and efficacy of the Micra~     Transcatheter Pacing System and to assess long term performance.~   "
119387|NCT02004860|"~     Seborrheic dermatitis is a chronic inflammatory dermatological disease, evolving by relapses,~     affecting mainly the face and scalp. It would be important to have a maintenance treatment~     for severe forms of seborrheic dermatitis witch is both effective and relatively well~     tolerated to reduce the frequency of relapses, prolong remissions obtained after attack~     treatment and reduce the use of topical steroids.~   "
119391|NCT02004808|"~     NETs formation in vaso-occlusive events in sickle cell disease and the role of hydroxyurea~     treatment.The study hypothesis is that NETs formation by neutrophils has a role in the~     induction of vaso occlusive disease in blood vessels. It is possible that high leukocyte~     count in children with sickle cell anemia is a bad prognostic sign due to NETs formation~     supporting occlusion of peripheral and central blood vessels.Hydroxyurea treatment might~     prevent vaso occlusive syndrome not only by increasing HbF but also by decreasing neutrophil~     count and inhibiting NETs formation.~   "
119392|NCT02004795|"~     This is a boron neutron capture therapy (BNCT) combined with image-guided intensity~     modulation radiotherapy (IG-IMRT) for patients with previously irradiated and locally~     recurrent head and neck cancer. The primary end points are treatment toxicities and response~     rate. The secondary endpoints are time to tumor progression, progression-free survival,~     overall survival and change quality of life.~      Head and neck(H & N) carcinomas that recur locally after conventional irradiation pose a~     therapeutic challenge. Boron neutron capture therapy (BNCT) is based on the nuclear capture~     reaction that occurs when non-radioactive boron is irradiated with neutrons of thermal energy~     to yield high energy alpha particles and recoiling lithium nuclei. The effect of alpha and~     7Li is primarily limited to boron-containing cells. Preferential uptake of boron into~     cancerous tissue is achieved using boron carriers such as a derivative of phenylalanine,~     boronophenylalanine (BPA). After administration of BPA by intravenous infusion, the tumor~     site is irradiated with neutrons, the source of which is currently a nuclear reactor, like~     the Tsing Hua Open-Pool Reactor (THOR), a 2MW research reactor at National Tsing Hua~     University (NTHU) in Taiwan. Since it is a target radiotherapy, low complication rate after~     BNCT can be obtained. However, further local recurrence after BNCT for recurrent H & N cancer~     was reported in several publications.~      Image-guided radiation therapy (IGRT) is the process of frequent two and three-dimensional~     imaging, during a course of radiation treatment, used to direct radiation therapy utilizing~     the imaging coordinates of the approved radiation treatment plan. IGRT such as Cone-Beam CT~     (CBCT) using an On-Board Imager (OBI) enhance delivery and further improve outcomes as the~     treatments create a higher level of precision. By combining BNCT and IG-IMRT, we expect to~     procure high control rate of recurrent H & N cancer with acceptable toxicity. This study will~     be the first BNCT plus IG-IMRT trial to treat head and neck cancer in Taiwan.~   "
119393|NCT02004782|"~     Barretts mucosa is a premalignant condition of the oesophagus, which can progress to cancer.~     Oesophageal cancer is aggressive, with a 5 year survival of only ~15%. High risk Barretts~     mucosa, containing high grade dysplasia or early cancer, can be removed by endoscopic mucosal~     resection (EMR) during gastroscopy. If patients can be effectively treated by EMR while they~     have premalignant or early malignant disease, it is a curative procedure.~      Currently, the major limitation of Complete Barretts Excision (CBE) by EMR, is scar tissue~     development in the oesophagus, leading to stricture formation and difficulty swallowing~     (dysphagia). If a safe and effective method could be found to reduce this risk, the treatment~     options for early oesophageal cancer would be greatly improved. CBE is performed as a two~     stage procedure, with 2 gastroscopies 8 weeks apart. In this randomised, doubleblind study,~     eligible and enrolled patients are randomised after the 1st stage CBE to receive either~     prednisolone tablets or placebo. Inclusion criteria are patients with short segment (<3cm~     circumferential disease) Barretts oesophagus with high grade dysplasia or early cancer. The~     treatment period is for 6 weeks after both CBE sessions. Prednisolone is given in a reducing~     dose over the 6 weeks, starting at 40mg daily.~      The primary outcome is symptomatic dysphagia development. Endoscopic dilation will be~     performed as required for dysphagia secondary to symptomatic oesophageal stricture formation~     persisting for ≥2 days, or complete dysphagia for any time period. Endoscopic surveillance~     with biopsies will occur at a 3 month, 6 month then 12 month interval following CBE, to~     assess for complete removal of Barretts mucosa.~      Following two stage CBE, stricture rates without preemptive therapy in noncircumferential,~     circumferential <2cm, and circumferential <3cm disease, are estimated to be 30%, 50% and 70%~     respectively. The investigators predict a 50% reduction in stricture rate with oral steroid~     therapy. With a primary analyses of oral steroid versus placebo tested at a 5% level of~     significance in a two tailed test, 58 patients are needed per group. Allowing for a 5% drop~     out rate, a total of 126 patients are required. The study will be performed at five~     Australian Tertiary Hospitals, and the recruitment period is estimated to be 2 years.~   "
119394|NCT02004769|"~     Patients with inoperable, locally advanced or recurrent and/or HER2-positive metastatic~     gastric or gastro-esophageal junction cancer, with no prior treatment for metastatic disease~     are to be recruited in the study. In the current study, the efficacy and safety of~     Trastuzumab in combination with Capecitabine/Docetaxel will be evaluated in Chinese patients~     with HER2 positive advanced or recurrent gastric cancer.60 patients could provide adequate~     precision rather than controlling type I&II error. Assuming the target PFS is 6.7m, 60~     patients will give 90% CI of (5.5, 8.4). Considering the 5% drop out rate, 65 patients will~     be enrolled.~   "
119395|NCT02004756|"~     Primary Objective: To determine if impairments in cardiac and musculoskeletal function and~     metabolism exist in Fontan children.~      Secondary Objectives:~        1. To determine if impairments do exist, are they related to exercise capacity.~        2. To determine if a 12-week exercise training intervention improves cardiac and/or~          musculoskeletal metabolism.~      Hypothesis: The investigators hypothesize that abnormalities in cardiac and skeletal function~     are evident, influence exercise capacity, and can be improved with exercise training.~   "
119396|NCT02004743|"~     Sunnybrook Health Sciences Centre is Canada's largest trauma centre, treating 1,100 patients~     annually. A traumatic experience can lead to post-traumatic stress disorder, which increases~     hospital stays, emergency visits and disability. Despite developing leadership to manage a~     Code Orange mass trauma, Sunnybrook lacks guidelines in the psychological management of~     patients who have experienced trauma. The department of psychiatry currently holds a~     Traumatic Brain Injury clinic and PTSD services for youth but lacks both immediate~     intervention, prevention and adult services. This research will enable us to gain best~     evidence expertise to develop guidelines as well as a sustainable PTSD treatment program,~     with clear outcomes to assess effectiveness, psychiatric morbidity, use of healthcare,~     disability and substance abuse.~      The five world-expert-consensus intervention resilience based principles will be~     operationalized in guidelines for the management of trauma patients, their caregivers and in~     routine nursing and trauma team care from the Emergency to the ward, and discharge, through~     to outpatient care. It is hypothesized that this will improve the psychological recovery of~     patients at risk of developing PTSD after a traumatic injury. In addition, early screening~     and intervention for increased risk of PTSD will be implemented one month after the trauma.~     It is hypothesized that such trauma informed psychological management, early screening and~     expert treatment using prolonged exposure will reduce hospital stays, functional disability,~     as well as longer-term psychiatric morbidity, including substance abuse.~   "
119397|NCT02004730|"~     The purpose of this study is to determine whether patients with diffuse or multivessel~     coronary artery disease may benefit from the percutaneous implantation of the device ABSORB~     in larger extent with respect to the general population of patients undergoing percutaneous~     treatment of coronary artery disease.~   "
119398|NCT02004717|"~     This is an open-label, sequential dose escalation and expansion study to evaluate the safety,~     tolerability, and pharmacokinetics of DS-8895a in Japanese subjects with advanced solid~     tumors.~   "
119695|NCT02000830|"~     The objectives of this follow up study are to evaluate the long-term effects of stannsoporfin~     (Stanate) on the health, growth, and development of patients who received a single dose of~     stannsoporfin with PT used to treat hyperbilirubinemia compared with patients in the control~     (placebo plus PT) group in clinical trial 64,185-204.~   "
119400|NCT02004691|"~     Primary Objective:~      The primary objective of this phase 2/3 study is to evaluate the efficacy of olipudase alfa~     (recombinant human acid sphingomyelinase) administered intravenously once every 2 weeks for~     52 weeks in adult patients with acid sphingomyelinase deficiency (ASMD) by assessing changes~     in: 1) spleen volume as measured by abdominal magnetic resonance imaging (MRI) (and, for the~     United States [US] only, in association with patient perception related to spleen volume as~     measured by splenomegaly related score [SRS]); and 2) infiltrative lung disease as measured~     by the pulmonary function test, diffusing capacity of the lung for carbon monoxide (DLCO).~      Secondary Objectives:~        -  To confirm the safety of olipudase alfa administered intravenously once every 2 weeks~          for 52 weeks.~        -  To characterize the effect of olipudase alfa on the patient perception related to spleen~          volume as measured by the SRS after 52 weeks of study drug administration. (For the US,~          the effect of olipudase alfa on the splenomegaly related score is part of the primary~          objective).~        -  To characterize the effect of olipudase alfa after 52 weeks of study drug administration~          on the following endpoints assessed sequentially:~        -  The effect of olipudase alfa on liver volume;~        -  The effect of olipudase alfa on platelet count;~        -  The effect of olipudase alfa on fatigue;~        -  The effect of olipudase alfa on pain;~        -  The effect of olipudase alfa on dyspnea.~   "
119401|NCT02004678|"~     DS-1150b is being developed by Daiichi Sankyo for the treatment of Type 2 Diabetes Mellitus.~     This is a Phase I, single-blind (subjects and principal investigator blinded, Sponsor~     unblinded), placebo‑controlled, randomized, 2‑part, sequential, single ascending dose, single~     center study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of~     single oral dose of DS‑1150b in healthy subjects and subjects with Type 2 Diabetes Mellitus.~   "
119402|NCT02004665|"~     to evaluate the incidence of delirium in patients with acute coronary syndrome and its~     correlation with adverse events~   "
119403|NCT02004652|"~     The purpose of this study is to evaluate the effect and safety of prucalopride on recovery of~     gastrointestinal function in patient undergoing major gastrointestinal surgery. The~     investigators hypothesize that patients who take prucalopride after major gastrointestinal~     surgery will have shorter duration of postoperative ileus.~   "
119404|NCT02004639|"~     Trismus Prevention, Diagnosis and Management: Radiotherapy Planning, Early detection, and~     Physical Therapy Intervention~   "
119405|NCT02004626|"~     This is a Clinical study Phase III, Prospective, Randomized, Controlled, Double-blind,~     Multicenter, National, Non-inferiority.~      Its purpose is to determine the noninferiority in efficacy of an investigational product in~     relation to the product available in the market intended of treating pressure ulcers.~   "
119406|NCT02004613|"~     Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery~   "
119407|NCT02004600|"~     The hereditary dystrophic epidermolysis bullosa are genodermatosis responsible of a poor~     adhesion of the epidermis to the dermis pulling a large mucocutaneous fragility and recurrent~     spontaneous or posttraumatic bullous detachment. They are caused by mutations in the COL7A1~     gene encoding for the collagen VII.~      No curative treatment is avaible. The main cause of patients death is the development of~     squamous cell carcinoma, sometimes multiple and paticularly aggressive in repeated healing~     part. The photodynamic therapy (PDT) is one of technical reference of multiple actinic~     keratoses lesions for adults, which are also pre-epithelioma lesions. The PDT is well~     tolerated even by the elderly and requires only a single session.~      The main objective of this study is to determine the efficiency of the photodynamic therapy~     in the treatment of epidermic dysplasies for patients affected by dystrophic epidermolysis~     bullosa (DEB). The secondary objectives are to evaluate the tolerance of this treatment in~     terms of pain and healing, and to evaluate the contribution of confocal microscopy in the~     diagnosis of epidermal dysplasia for patients affected by hereditary dystrophic epidermolysis~     bullosa. The main evaluation criterion is the cutaneous biopsy before and after (M2) a PDT~     session of an epidermal dysplasia area. The secondary criteria are the evaluation of the pain~     during the PDT session and the healing of the cutaneous lesion at M0, M2 and M4 (lesion area~     and healing time) and correlation histology / MC. Each patient with a suspicious lesion will~     be biopsied. In case of agreement for this protocol, there will be 1 PDT session followed by~     a consultation of control at 2 and 4 months after the end of treatment.~   "
119408|NCT02004587|"~     The trial will investigate the influence of hepatic function on the PK of gemigliptin. In an~     additional treatment period, the PK and safety of multiple dosing of gemigliptin in healthy~     White subjects will be investigated.~   "
119409|NCT02004574|"~     The combination of calcipotriol and betamethasone dipropionate used in an ointment~     formulation (Daivobet® ointment) has shown to have an excellent efficacy and safety in the~     short-term and long-term management of psoriasis vulgaris. A newly developed gel formulation~     (Xamiol® gel) of calcipotriol and betamethasone dipropionate has recently been approved and~     marketed in Korea as a topical treatment of moderate to severe scalp psoriasis and non-scalp~     psoriasis vulgaris.~      Xamiol® gel, the investigational product (IP) used in this study, prevents keratinization by~     normalizing the reproduction cycle of skin cells. It also relieves itching associated with~     psoriasis. Xamiol® gel was initially approved for treatment of moderate to severe scalp~     psoriasis and its label was extended to non-scalp psoriasis vulgaris in October 2012.~      Since patient compliance is one of the important factors in achieving effective outcomes in~     the treatment of psoriasis, the once daily dosing of Xamiol® gel is expected to enhance~     compliance and treatment outcomes as well as to provide a safe and effective therapeutic~     option.~   "
119410|NCT02004561|"~     Determine the short and long term safety and efficacy of the Gastric bypass , laparoscopic~     sleeve gastrectomy, and Gastric banding (LAGB) on severely obese adolescents. The procedure~     selection is made by the patient or patient and guardian. This is not a randomized trial.~   "
119411|NCT02004548|"~     Primary Objective: To evaluate the safety, tolerability and maximum tolerated dose (MTD) of~     daily oral administration of metatinib tromethamine in subjects with solid tumors;~     Investigate the influence of food on pharmacokinetic parameters.~      Secondary Objective: To evaluate the plasma pharmacokinetics (PK) of daily oral~     administration of metatinib tromethamine in subjects with solid tumors; To observe~     preliminary anti-tumor efficacy; To evaluate potential pharmacodynamic and predictive~     biomarkers at MTD.~   "
119412|NCT02004535|"~     The objective of this study is to investigate benefits of binaural hearing for~     non-traditional cochlear implant candidates (with Asymmetric Hearing Loss). Asymmetric~     candidates are patients with severe to profound hearing loss in one ear and better hearing in~     the other ear. (One ear is deaf and the other ear has better hearing and in most cases uses a~     hearing aid.) The investigators hypothesize that cochlear implantation of the poorer ear~     provides a functional increase in word and sentence understanding in quiet or noise,~     perceived benefit, localization ability, and other measures of auditory performance relative~     to use of the better hearing ear alone.~   "
119413|NCT02004522|"~     A Phase 3 clinical trial to examine the efficacy of IPI-145 monotherapy versus ofatumumab~     monotherapy in subjects with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or~     Small Lymphocytic Lymphoma (SLL).~   "
119414|NCT02004509|"~     Introduction: Patients with atrial fibrillation (AF) have a substantial risk of stroke and~     systemic embolism. Subclinical AF is often suspected to be the cause of stroke in these~     patients. The detection of asymptomatic AF episodes is a challenge and the real rate of~     occurrence of these episodes remains unknown. The rate of stroke is high among patients who~     have received a pacemaker and this device can detect subclinical episodes of rapid atrial~     rate, which correlate with electrocardiographically documented AF. The net benefit of~     anticoagulant treatment is well established in patients with clinical AF but data about~     anticoagulation in subclinical AF setting is unknown. The aim of this study is to assess the~     impact of anticoagulant therapy on subclinical AF, directed by cardiac implantable electronic~     device (CIED) intensive monitoring, on the incidence of stroke and systemic embolism and~     correlate the AF episodes detected by CIED with thromboembolic events. Methods: This is a~     prospective, randomized, unicentric, parallel clinical study in patients with~     atrioventricular pacemaker, defibrillator or cardiac resynchronization therapy devices in~     sinus rhythm and CHADS2 score (an index of the risk of stroke in patients with atrial~     fibrillation, range from 0 to 6) ≥ 2 . Patients will be randomized to the intervention group~     - intensive monitoring arm (Group I) or control group - routine schedule arm (Group II) in a~     1:1 ratio. Time to inclusion will be 24 months and all patients will be followed up for a~     period of 36 months. Group I patients will be submitted to device data collection every 2~     months, while the Group II patients will be managed conventionally. Patients from Group I~     with episodes of subclinical AF will receive anticoagulant therapy, as well as patients with~     clinical AF of both arms. Device data from Group II patients will not be analyzed until they~     achieve the primary endpoint. Primary endpoint: stroke or systemic embolism. Secondary~     endpoints: subclinical AF rate, total mortality, cardiovascular mortality, myocardial~     infarction, cardiovascular hospitalization and bleeding rates. Expected outcome: It is~     expected that anticoagulation therapy of subclinical AF directed by CIED intensive monitoring~     will reduce the incidence of stroke and systemic embolism comparing to patients with~     non-diagnosed subclinical AF.~   "
119415|NCT02004496|"~     Health care has an increasingly demand for mobile applications (App), but studies are rare,~     which explore the added value and benefits for patient and physician. Patients in different~     disease groups or physicians from different specialties are likely to have different demands.~     Research should focus on selected groups to better understand their individual demands. Our~     study intends to identify the added value of mobile symptom tracking in a selected subgroup~     of patients. We designed an App for breast cancer patients, who receive ambulant chemotherapy~     in a breast center. The patients track regularly their well-being and adverse events (AE)~     with the smartphone- or web-app and share it with the physician in the medical consultation.~     The data entry was designed to meet patient needs based on previous usability testing.~      The reporting of AE and well-being are standardized according to the definitions by CTCAE 4.0~     and ECOG-Index to ensure the reliability of patient self-reporting.~      The primary outcomes are the number of reported AE, the influence on their subjective~     well-being and the acceptance of context specific information. We will include 150~     participants in this study. The calculated power is 91% respectively 80% for a 10 %~     improvement of well-being and a 2.2 increase of detected AEs.~      The results will be compared to patients without App and to patients with App but without~     shared information.~        -  Trial with medical device~   "
119416|NCT02004483|"~     Investigators will analyzed systolic and diastolic function during and after ischemia induced~     by percutaneous coronary intervention.Also will be analyzed a local work index during acute~     ischemia induced by percutaneous coronary intervention.~   "
119417|NCT02004470|"~     The use of laparoscopy in gynecologic surgery has been well established to decrease~     morbidity, blood loss, hospital stay, and post-operative pain when compared to traditional~     open abdominal surgery. However, the laparoscopic technique is associated with post-operative~     shoulder pain.~      We hypothesize that a combination of intraperitoneal saline lavage and active suction removal~     of carbon dioxide gas from the right upper quadrant of the abdomen will decrease incidence of~     post-laparoscopic shoulder pain when compared to passive exsufflation of carbon dioxide gas.~   "
119418|NCT02004457|"~     Engagement in primary care for People Living with HIV/AIDS (PLWHA) is a significant public~     health concern because reduced commitment to care puts PLWHA at risk for illness progression,~     death, and transmission of HIV to others. This project will develop a novel treatment, brief~     acceptance-based behavior therapy (ABBT), to promote self-acceptance of HIV status as a~     pathway to reducing engagement barriers. The clinical and public health impact of this~     project will be the development of a simple, low-cost, disseminable intervention that~     enhances longitudinal commitment to care so PLWHA can obtain effective medical treatments~     that will prolong survival and improve quality of life. We hypothesize that individuals~     randomized to brief ABBT will showed increased longitudinal attendance of primary care~     appointments.~   "
119419|NCT02004444|"~     JC virus is a benign virus which infects approximately up to 90% of the normal adult~     population. However, it may be reactivated in people who have a decreased immune function as~     in HIV infection, cancer, chemotherapy, transplant recipients, or in MS patients treated with~     natalizumab (Tysabri). In these patients, JC virus can cause a severe brain disease called~     Progressive Multifocal Leukoencephalopathy (PML), for which there is no cure.~      As of September 2013, 400 MS patients in the world, who have been treated with natalizumab,~     have developed PML. The risk of PML is approximately 5 patients in 1000 after 24 months on~     the drug. Researchers do not know exactly in which cells of the body the virus lives but it~     has been isolated from the blood, urine, cerebrospinal fluid (CSF), and from the brains of~     patients with immunosuppression.~      In this study, the investigators wish to determine precisely where the virus lives, and how~     the body prevents it from causing brain disease.~      Because of the association of PML with natalizumab, the investigators would like to see if~     there is a difference in the amounts of virus in blood, urine, and CSF found in MS patients~     treated with natalizumab or those treated with different medications for MS, or those not~     treated at all. The investigators hope that this knowledge will allow us to find better ways~     of preventing the development of PML as well as treatments for patients with PML.~   "
119705|NCT02000700|"~     The purpose of this study is to evaluate the pharmacokinetics (blood levels) and~     pharmacodynamics (the action or effects a drug has on the body) of canagliflozin in children~     and adolescents with type 2 diabetes mellitus aged 10 to 17 years (inclusive). Other purposes~     are to investigate safety and assess the ease of swallowing the tablets.~   "
119420|NCT02004431|"~     The experience of pain is common among hospital inpatients. Orthopaedic surgery often results~     in significant pain, which may last for some time. About one in eight people will experience~     long-term or chronic pain after surgery, which can impact on quality of life and mood. Some~     risk factors are known for chronic post surgical pain (CPSP) and these include patient~     factors, surgical factors and anaesthetic factors. We know that mood problems (anxiety and~     depression) increase the risk of CPSP. What is not known is how short term changes in mood~     are related to the experience of pain after surgery and how this impacts on CPSP. This study~     is designed to investigate the relationship between both short and long-term mood problems~     and short and long-term pain and quality of life after orthopaedic surgery. The study will~     provide valuable information to allow us to design a psychological intervention, which might~     reduce the risk of short-term post surgical pain and CPSP.~      This study also aims to measure a number of other variables, which may be related to CPSP~     including medication use, other medically unexplained symptoms and catastrophic thinking in~     response to pain.~      All patients having planned orthopaedic surgery will be asked to enter the trial. Those~     consenting to involvement will complete a questionnaire assessing the variables described~     above. They will be divided into two groups depending on whether they have significant pain~     on the day after their surgery. As the primary aim of the study, the rates of significant~     anxiety or depression will then be compared between these two groups.~      Secondary outcomes will be assessed by a questionnaire sent to the patients at 6 months after~     their surgery. Descriptive statistics will be produced for all the variables and use to model~     a future study, which would assess the effect of a psychological intervention on acute and~     chronic post surgical pain.~      Our hypothesis is that patients are more likely to experience acute anxiety and depression or~     display catastrophic thinking if they suffer significant post-surgical pain. The study is~     powered to reliably detect a three-fold difference in the prevalence of psychopathology~     between patients with and without acute pain on day 1 after elective orthopaedic surgery.~   "
119421|NCT02004418|"~     Patients with localized prostate cancer are routinely treated with radiation therapy to the~     entire prostate gland. The investigators can identify where the cancer is concentrated in the~     prostate gland using a newer specialized imaging technique called 11C Choline PET (stands for~     choline positron emission tomography). This is different from the older type of PET scan that~     has been used in the past (called FDG PET) which has not been as accurate as the new PET scan~     for identifying where the cancer is in the prostate gland. It has also been shown that~     delivering higher doses of radiation to prostate cancer cells in the prostate have resulted~     in better cure rates in patients with prostate cancer. Therefore for goal number one the~     investigators want to give higher radiation dose to the prostate cancer cells. But the~     challenge has been that delivering higher doses of radiation to the prostate gland may also~     increase the chance of complications from the higher doses of radiation to the rectum,~     bladder and surrounding area. Therefore for goal number two the investigators want to~     minimize radiation dose to the rectum, bladder and surrounding area. 3-Tesla Magnetic~     Resonance Imaging (3T MRI) is a new kink of scan that will be used in this study to identify~     the urethra in the prostate so that the investigators can minimize the radiation dose to the~     urethra. The investigators believe the 3T MRI scan is able to point to the areas of cancer~     that may be able to predict how well the treatments may work, as well as which areas of the~     tumor appear to be responding to failing.~      In this study, the investigators will keep the dose of radiation to the rectum and bladder as~     low as possible while increasing radiation dose to parts of the prostate with more cancer~     cells. The investigators will compare the cure rates in this study with the cure rates of~     other patients receiving the standard treatment in which the same dose of radiation is~     delivered throughout the prostate gland. The investigators will also compare the rates of~     complications in this study with the rates of complications in patients receiving the~     standard treatment in which the same dose of radiation is delivered throughout the prostate~     gland.~   "
119422|NCT02004405|"~     Abstract Objective: Autonomic dysfunction is an important mechanism that could explain many~     symptoms observed in fibromyalgia (FM). Exercise is an effective treatment, with benefits~     potentially mediated through changes in autonomic modulation. Strengthening is one of the~     less studied exercises in FM, and the acute and chronic effects of strengthening on the~     autonomic system remain unknown. The objective of this study is to assess the effects of~     strengthening exercises (STRE) on autonomic modulation, pain perception and the quality of~     life (QOL) of FM patients. Methods: Sedentary women with FM (ACR 1990) will be randomly~     selected to STRE or flexibility (FLEX) exercises in a blind controlled trial. The intensity~     of STRE will be set at 45% of the estimated load of 1 Repetition Maximum (RM) in 12 different~     exercises. The primary outcomes will be pain measured using the Visual Analog Scale (VAS) and~     the Heart Rate Variability (HRV) analysis. Other outcomes will be assess: fitness measured by~     treadmill test, the sit and reach test (Wells and Dillon's Bench), handgrip dynamometry; and~     quality of life by the Fibromyalgia Impact Questionnaire (FIQ), the Beck and Idate~     Trait-State Inventory (IDATE), a short-form health survey (SF-36). Statistical analyses and~     ethical procedures: The visual analog scale (VAS) for pain will be the primary measure used~     to determine sample size. Statistical significance will be set at 5% and power of 80%. These~     led to at least 58 participants to be randomized. The main hypothesis is that strengthening~     exercise is a better treatment than flexibility exercise to improve pain, HRV and quality of~     life. In all measures tested we will consider the null hypothesis (H0) as being the point of~     equality between groups tested and H1 the point of difference. Bilateral tests were carried~     out adopting a 5% level of significance. The normality of the results will be tested using~     the Shapiro-Wilk test. Student's t-test for paired samples will be used to perform~     intra-group comparisons at different times, when the data were normally distributed, and the~     nonparametric equivalent of Student's t-test (Wilcoxon test) will be used when the data show~     an asymmetrical distribution. To compare the data between the STRE and FLEX groups, ANOVA for~     repeated measures will be used, followed by post-hoc Bonferroni's test.~   "
119423|NCT02004392|"~     This is a 26-week, randomized extension of the Phase 3 double-blind placebo-controlled~     studies, EVP-6124-024 and EVP-6124-025. In this extension study, subjects who complete study~     EVP-6124-024 or EVP-6124-025 and fulfill all entry criteria will be randomized to receive~     EVP-6124 for an additional 26 weeks.~   "
119424|NCT02004379|"~     Know through routine clinical practice the effectiveness and safety of current treatment of~     hepatitis C virus, genotype 1, for patients who have never been treated and for patients who~     have been previously treated~   "
119425|NCT02004366|"~     A total of 280 patients with type 2 diabetes (T2DM) who have undergone surgical procedure~     will be enrolled in the study. These patients could be on diet, oral hypoglycemia medication~     or low dose insulin prior to their admission.~      This study is a prospective, randomized, open label trial to compare the safety and efficacy~     of linagliptin (an oral anti diabetic medication) given orally once daily to an insulin~     regimen of glargine once daily plus rapid-acting insulin before meals. Both of these~     treatment groups will be given corrective doses of rapid-acting insulin analogs (aspart,~     lispro or glulisine) before meals if their blood sugars are > 140 mg/dl.~      The patients will be monitored for their blood sugars while the hospital.~      If patients are agreeable to participate in the discharge part of the study, the~     investigators will randomized them to a treatment group based on their admission HbA1c. The~     investigators will follow these patients for 3 months with phone calls and clinic visits, and~     will monitor their blood sugars. This is to compare the efficacy of linagliptin and our~     discharge treatment algorithm in controlling blood sugars as out patients.~   "
119426|NCT02004353|"~     The purpose of this study is to collect patient related benefit data following treatment for~     permanent hearing loss with a hearing implant from the company Cochlear over a period of 2~     years post treatment.~      Assessment of benefits is based on standard questionnaires of hearing ability and quality of~     life in general.~   "
119427|NCT02004340|"~     The purpose of this study is to determine whether transcutaneous auricular vagus nerve~     stimulation as a complementary therapy is effective in the treatment of pediatric epilepsy.~   "
119428|NCT02004327|"~     1. Objective After single dose in healthy adults the capacity of the Group for DW1029M~          evaluate the pharmacokinetic characteristics.~        2. Indication Diabetic kidney disease~        3. Efficacy~             1. Primary~                  -  AUClast, AUCinf, AUClast/D, AUCinf/D~                  -  Cmax, Cmax/D~             2. Secondary~                  -  Tmax, t1/2, CL/F, Vz/F~        4. Safety~             1. Adverse Event Monitoring~             2. V/S, EKG, Laboratory Test, P/E~   "
119706|NCT02000687|"~     This is a single-center, prospective, open label study in islet transplant recipients~     following islet graft loss.~   "
141654|NCT01713153|"~     This is a large, community-based, cluster-randomized trial to compare routine prophylactic~     use of 600 mcg oral misoprostol and 10 IU oxytocin delivered by UnijectTM intramuscularly~     during the third stage of labor~   "
119429|NCT02004314|"~     This study will evaluate the effect of chloroquine in individuals infected with HIV.~     Researchers will aim to determine if chloroquine treatment in participants whose viral loads~     are suppressed on combination antiretroviral therapy (ART), results in improved immune~     activation and CD4 cell recovery.~      The study will recruit 20 individuals and will last approximately 44 weeks. Eligible~     participants will receive an oral dose of chloroquine (250 mg) once daily from week 8 through~     week 32. All participants will be asked to have rectal biopsy samples (week 0 and week 32) to~     study T cell immune activation in the mucosa rectal site.~   "
119430|NCT02004301|"~     This is a single-centre, open-label, non-randomised, two-arm study in 12 healthy male~     volunteers. This study is designed to correlate the gastrointestinal transit behaviour of~     delayed-release diclofenac potassium tablets with their pharmacokinetic (PK) absorption~     profiles.~      We will be looking at:~        1. The behaviour of the tablets (when, where and how quickly they break up)~        2. The gastric emptying time of the tablets (when they leave the stomach)~        3. The gastrointestinal transit of the tablets (how long they take to travel through the~          gut)~        4. Blood levels of the drug (diclofenac)~   "
119431|NCT02004288|"~     The aim of this study is to investigate whether Lactobacillus reuteri could have a beneficial~     role in treatment of children and adolescents with Anorexia nervosa who develop motility~     disorder due to the malnutrition regarding the normalization of the motility, as well as the~     possible role of probiotics on nutritional recovery, especially on bone health.~   "
119432|NCT02004275|"~     This randomized phase I/II trial studies the side effects and best dose of pomalidomide and~     ixazomib when given together with dexamethasone and to see how well pomalidomide and~     dexamethasone with or without ixazomib works in treating patients with refractory multiple~     myeloma. Biological therapies, such as pomalidomide and dexamethasone, may stimulate the~     immune system in different ways and stop tumor cells from growing. Ixazomib may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet~     known whether pomalidomide and dexamethasone are more effective with or without ixazomib in~     treating multiple myeloma.~   "
119433|NCT02004262|"~     Test the safety, immune response and efficacy of GVAX pancreas vaccine (with~     cyclophosphamide) and CRS-207 compared to chemotherapy or CRS-207 alone in adults with~     previously treated metastatic pancreatic adenocarcinoma~   "
119434|NCT02004236|"~     Interventional, prospective, randomized, double-blind, placebo-controlled and parallel~     assignment study, in which patients with Autism Spectrum Disorder (ASD) are two types of~     intervention by transcranial random noise stimulation (tRNS), to improve verbal fluency and~     empathy.~   "
119435|NCT02004223|"~     Current standard treatment for prostate cancer involves giving patients approximately 40~     doses of radiotherapy, one dose per day over an 8 week period. The purpose of this study is~     to assess the effects of giving two separate high doses of a special type of precision~     radiotherapy to the prostate and then 5 weeks (instead of 8 weeks) of standard radiotherapy.~      Hypothesis: It is safe to give patients an extra two doses of high-precision radiotherapy~     prior to commencing a shorter period of standard radiotherapy for prostate cancer.~   "
119436|NCT02004210|"~     The aim of this study is to compare the efficacy of conventional transarterial~     chemoembolization(TACE) and transarterial radioembolization in patients with unilobar~     advanced hepatocellular carcinoma.~   "
119437|NCT02004197|"~     Helicobacter pylori is strongly associated to the development of gastrointestinal disorders.~     Emerging antibiotic resistance and poor patient compliance of modern therapies has resulted~     in significant eradication failure. Clinical trial was conducted to see the efficacy of~     current quadruple and phytomedicine-based therapies for the eradication of H. pylori~     infection and relief in its associated symptoms in Pakistan.~   "
119438|NCT02004184|"~     Non-small-cell lung cancer (NSCLC) accounts for a majority (approximately 85%) of lung cancer~     cases. Patients with localized disease can be cured through surgery, but only 20 % are~     operable.For the majority of patients with advanced disease, palliative cytotoxic~     chemotherapy remains the recommended therapy. Chemotherapy prolongs survival and improves~     quality of life.~      The recommended first-line therapy is 4-6 courses of a platinum in combination with a third~     generation compound (e.g. gemcitabine, vinorelbine, docetaxel, pemetrexed, paclitaxel). After~     first-line therapy, it has been recommended to observe the patients and offer second-line~     chemotherapy at disease progression.~      Regimens for second-line therapy include docetaxel or pemetrexed monotherapy. Pemetrexed is~     less toxic and superior to gemcitabine in non-squamous NSCLC, whereas docetaxel is the~     recommended second-line therapy in squamous cell carcinoma.~      The results of the studies of maintenance pemetrexed therapy are encouraging; the observed~     survival benefit is clinically relevant and relatively large considering the poor survival in~     patients with advanced NSCLC. Furthermore, pemetrexed appears to be well tolerated. There~     are, however, several limitations to the studies that have been conducted: Relatively few~     elderly patients and no PS 2 patients were enrolled - and not all patients on the~     control-arms received pemetrexed at progression.~      The overall aim of this study is to investigate whether immediate maintenance pemetrexed~     therapy prolongs survival compared to observation and pemetrexed therapy at progression in~     patients with advanced NSCLC. Furthermore, it will be explored whether patients with~     'performance status' 2 and elderly ≥ 70 years tolerate and benefit from maintenance therapy;~     and what characteristics and blood biomarkers are associated with sensitivity and~     tolerability of such therapy.~   "
119439|NCT02004171|"~     Electronic cigarettes have shown promise but have yet to proven effective for smoking~     cessation. This trial will evaluate the effectiveness of electronic cigarettes in smokers who~     are trying to quit smoking compared with a standard therapy, the nicotine inhaler. The~     investigators hypothesize that electronic cigarettes will be comparable to the nicotine~     inhaler in terms of smoking cessation.~   "
119440|NCT02004158|"~     In this proof-of-concept study, the investigators will assess the ease and usefulness of a~     positive psychology program in patients with acute coronary syndrome and less-than-optimal~     adherence to health behaviors. The investigators believe that positive psychology (a field~     that studies boosting positive emotions rather than simply reducing negative emotions) will~     help this cardiac population to be more healthy. The investigators want to determine whether~     this positive psychology program has the potential to be an adjunctive treatment for cardiac~     populations.~   "
119466|NCT02003820|"~     We hypothesize that oral hygiene habits in children 8-12 years of age can be improved using~     video format Social Story intervention techniques. The purpose of this study is to~     investigate the effectiveness of video format social stories used to inform and educate~     children and parents about proper dental hygiene technique over a 6 week intervention period.~     We will measure the success of intervention using data collected from clinical exams and~     caregiver/participant surveys. Evaluation of data collected will be used to determine the~     effectiveness of the intervention.~   "
119707|NCT02000674|"~     All adult patients with spontaneous cardiac activity and requiring tracheal intubation in the~     pre hospital emergency context will be included in order to compare the use of~     succinylcholine vs Rocuronium for prehospital emergency intubation.~   "
119441|NCT02004145|"~     In this study, the investigators will perform an exploratory randomized trial of Positive~     Psychology (PP). The trial will consist of 50 participants and will compare the impact of a~     phone-based PP intervention vs. an attentional control condition, in Major Depressive~     Disorder (MDD) patients who are hospitalized for SI or following a suicide attempt. This is a~     12 week trial with 6 weeks of intervention and two blinded follow-up assessments at 6 and 12~     weeks.~      Specific Aim #1: To assess the feasibility and acceptability of the phone-based PP~     intervention in this high-risk population.~      Hypotheses: The intervention will be feasible (with most patients completing at least 4/6 PP~     and with follow-up data from at least 80% of subjects). The ratings of ease and subjective~     helpfulness of the exercise and other mental states as measured before and after each PP~     exercise will be more than 6 out of 10 and higher than the same ratings obtained from~     subjects in the control condition.~      Specific Aim #2: To examine the impact of the six-session PP intervention on positive~     psychological well-being.~      Hypothesis: Compared to control subjects, subjects randomized to PP will have greater scores~     on scales of optimism (measured via the Life Orientation Test-Revised [LOT-R]), gratitude~     (Gratitude Questionnaire-6 [GQ-6]), and positive affect (Positive Affect Negative Affect~     Schedule [PANAS]) at 6 and 12 weeks.~      Specific Aim #3 (primary aim): To assess the impact of the PP intervention on key suicide~     risk factors.~      Hypothesis: PP subjects will have greater scores on scales of hopelessness (Beck Hopelessness~     Scale [BHS]; primary study outcome measure), suicidal ideation (SI) (Concise Health Risk~     Tracking scale [CHRT]), and depression (Quick Inventory of Depressive Symptomatology—Self~     Report [QIDS-SR]) at 6 and 12 weeks.~      We will also measure impact on readmission and suicide attempts to assess these key outcomes.~   "
119442|NCT02004132|"~     The study involves application of Axiron to each underarm. The study will evaluate the~     transfer of testosterone from underarms to the clothing items that the participant is wearing~     and other fabric items washed with participant's' clothes. The study is approximately 6 days,~     not including screening. Screening is required within 28 days prior to the start of the~     study.~   "
119443|NCT02004119|"~     This study is an randomized double-blind placebo-controlled study to evaluate the efficacy~     and the safety of oral KHK4577 for 6 weeks in patients with atopic dermatitis.~     Pharmacokinetics of KHK4577 will also be assessed.~   "
119444|NCT02004106|"~     This open-label, multi-center, dose-escalation study will evaluate the safety,~     pharmacokinetics, and therapeutic activity of RO6895882 in participants with Carcinoembryonic~     Antigen (CEA)-positive solid tumors who have progressed on the standard of care therapy. The~     study will be conducted in 3 parts. Part 1 will be a single ascending dose study in single~     participant cohort at low RO6895882 dose (less than or equal to [</=] 6 milligrams [mg]).~     Part 2 will be a dose-escalation study of RO6895882 monotherapy given every week (qw), every~     2 weeks (q2w), and possibly every 3 weeks (q3w). Part 3 will be an expansion phase of the qw,~     q2w, and possibly q3w at maximum tolerated dose (MTD) (as determined in Part 2). Part 3 will~     only be conducted if the risk/benefit assessment, as evaluated by the Sponsor and the~     investigators, is in favor of the participants. Participants will be treated until disease~     progression, unacceptable toxicity or withdrawal from treatment for other reasons or death~     for a maximum duration of 24 months.~   "
119445|NCT02004093|"~     This study will evaluate the efficacy and safety of pertuzumab in combination with~     carboplatin-based standard chemotherapy in patients with platinum-sensitive recurrent ovarian~     cancer. The anticipated time on study treatment is 3-12 months.~   "
119446|NCT02004080|"~     CREACTIVE is a large-scale observational cohort study concerning Traumatic Brain Injury (TBI)~     care in the ICU setting~   "
119447|NCT02004067|"~     In the present study the investigators aim to determine the efficacy of an immunomodulating~     topical medication, compared with a topical lubricant, on the treatment of dry eye disease~     (DED) due to primary or secondary Sjögren's syndrome (aqueous deficient DED) and evaporative~     DED.~   "
119448|NCT02004054|"~     The investigators' hypothesis is that measuring the PCTdynamics would be an easy and reliable~     symptom to evaluate in pathologies affecting the optic nerve~   "
119449|NCT02004041|"~     The purpose of this study is to test whether VLY-686 can reduce chronic pruritus in subjects~     with treatment-resistant pruritus associated with atopic dermatitis in comparison with~     placebo.~   "
119450|NCT02004028|"~     This is an open label neoadjuvant (treatment with VS-6063 prior to mesothelioma surgery)~     study in subjects with malignant pleural mesothelioma who are eligible for surgery. Subjects~     will receive VS-6063 (defactinib) 400 mg twice daily for 12, 21, or 35 days. Pre- and~     post-treatment biopsies and blood samples will be collected. The purpose of this study is to~     assess biomarker responses from tumor tissue. The safety, pharmacokinetics, and tumor~     response rate to VS-6063 (defactinib) will be also be assessed.~   "
119451|NCT02004015|"~     Phase III prospective randomised study : curare vs placebo, comparing bowel peristalsis~     (abdominal echography) in the first minutes of after general anesthesia induction.~      Primary End Point: proportion of patients with a score of motion = 0~   "
119452|NCT02004002|"~     The purpose of this proposal is to determine whether dietary protein restriction has~     beneficial effects on skeletal muscle insulin sensitivity and β-cell function in obese men~     and women.~   "
119453|NCT02003989|"~     HIV patients may suffer sooner from aging than average population, including brain aging. Our~     hypothesis is that if brain dysfunctions are explained by a quicker loss of neurons in HIV~     patients, this loss could be detected earlier by a thinning down of retinal nerve fiber layer~     (RNFL), compared to non HIV patients of the same age.~   "
119454|NCT02003976|"~     The purpose of this study is to compare patients with knee osteoarthritis (OA) receiving~     optimized non-surgical treatment plus surgical realignment of the tibia, or optimized~     non-surgical treatment only. We hypothesize that outcomes assessed at 12 and 24 months~     follow-up will suggest favourable changes in patients undergoing surgical realignment when~     compared to patients receiving non-surgical treatment only.~   "
119455|NCT02003963|"~     The purpose is to evaluate the feasibility of a 12-week exergaming dance program for~     adolescent girls. This study combines dancing, video games, and a full body work-out to test~     if video games can increase physical activity and promote healthy weight in adolescent girls.~     We hypothesize that girls who play the dance exergames, versus those in the control group,~     will lose weight, decrease body fat and visceral fat, improve cardiovascular health, increase~     physical activity, and improve psychosocial health including self-confidence and quality of~     life.~   "
119467|NCT02003807|"~     The pathogenesis of irritable bowel syndrome (IBS) is considered immune reaction of~     gastrointestinal tract. Therefore there is growing evidence that IBS could occur after~     gastroenteritis. However, little is known about the incidence of IBS after acute~     diverticulitis. We thought that post diverticulitis status could induce IBS because~     diverticulitis was also bowel inflammatory disorder. This survey was designed to identify~     incidence of post-diverticulitis IBS and risk factor in Korea.~   "
119468|NCT02003794|"~     To study the result of intravenous fluid in patients with acute ischemic stroke within 72~     hours.~   "
119456|NCT02003950|"~     Craving differs from hunger because it occurs even when a person is in a satiated state and~     in the absence of an energy deficit. Craving is usually triggered by specific foods and may~     be attributable to certain sensory properties of foods. Foods that are craved are often~     regarded as less healthy choices, and are higher in energy content. Chocolate is one of the~     most commonly reported foods craved by people in this country. Together, craving for~     chocolate has been suggested to be a possible cause of weight gain and access to chocolate~     therefore needs to be restricted.~      However, it remains unknown if restriction may induce maladaptive eating behaviors of~     chocolate cravers. The anticipation of going on a diet has been shown to cause restrained and~     disinhibited eaters to react by consuming more chocolate. In this study, we will examine if~     this response is also found in chocolate cravers when they are asked to undergo three weeks~     of chocolate restriction. This study will also examine chocolate cravers' response after the~     chocolate restriction is lifted. We hypothesize that chocolate consumption of cravers will~     increase both before and after chocolate restriction is imposed. We also hypothesize that~     chocolate craving is specific to the food rather than its sweet taste, and that chocolate~     cravers are less willing to substitute chocolate for salty snacks, natural snacks, and sweet~     non-chocolate snacks during the restriction.~   "
119457|NCT02003937|"~     Spinal muscular atrophy type III, (SMAIII) is a disease in the nerve cells in the spinal cord~     which leads to to progressive muscle weakness and atrophy. No effective treatment is~     available for SMA. We have previously shown that patients with muscular dystrophies improve~     oxidative capacity (VO2max), muscle strength and daily function by aerobic conditioning.~     Patients with SMAIII share many clinical features with these conditions, although the~     mechanism of muscle weakness is different. In this study, we investigated how patients with~     SMAIII respond to aerobic training.~      6 patients and 9 healthy age- and sex-matched controls completed a 12 weeks training program.~     Subjects performed a total of 42 training session of 30 min on a stationary cycle ergometer~     at home. The work intensity was moderate and set to match a target heart rate.~      Training induced an increase without inducing muscle damage. However, training-induced~     fatigue was a major complaint in all patients, and caused one patient to drop out, increased~     the need for sleep in three patients and two had to modify the training program.~      The fatigue limits the use of this therapy. The training-induced fatigue, which is not~     encountered in muscle diseases, warrants investigations into alternative training methods to~     improve quality of life in patients with SMAIII.~   "
119458|NCT02003924|"~     The purpose of this study is to assess the safety and efficacy of enzalutamide in patients~     with non metastatic prostate cancer.~   "
119459|NCT02003911|"~     Asthma is a chronic lung condition in children, and often requires hospitalization for acute~     exacerbations. Azithromycin has been used successfully in other chronic lung diseases,~     including cystic fibrosis. Despite limited clinical evidence, some pediatricians use~     azithromycin in children hospitalized with asthma, citing either treatment of atypical~     pathogens or its proposed anti-inflammatory properties. We propose a clinical trial to~     determine if azithromycin will shorten length of stay in children hospitalized with acute~     asthma exacerabations.~   "
119460|NCT02003898|"~     The purpose of this study is to evaluate the Threshold Suspend (TS) feature of the Medtronic~     MiniMed® 530G insulin pump in patients 16 and older with insulin requiring diabetes.~   "
119461|NCT02003885|"~     The purpose of this study is to determine desflurane's dose-dependent effect on left~     ventricular (LV) function in cardiac surgery. The change of tissue Doppler imaging (TDI) of~     lateral mitral valve annular velocity at three different desflurane concentrations would be~     analyzed by using intraoperative transesophageal echocardiography (TEE) in cardiac surgery~     patients~   "
119462|NCT02003872|"~     This is an open-label trial investigating the effect of Spatz 3 intragastric balloon on~     weight loss on obesity and associated co- morbidities.~      The study aim is to evaluate the effect of the intra gastric balloon on weight reduction and~     on related co- morbidities during 1 year of balloon implantation and a year following~     explantation.~   "
119463|NCT02003859|"~     Studies over the past two decades have convincingly demonstrated the role of barrier~     dysfunction in the pathogenesis of inflammatory bowel disease. It previously shown that~     optical biopsy with probe-based confocal laser endomicroscopy (pCLE) could be used to assess~     mucosal barrier function. Furthermore, mucosal barrier dysfunction on pCLE was shown to be~     predictive of disease relapse in adult IBD patients. The purpose of the current study is to~     determine the predictive value of pCLE findings in pediatric IBD patients.~   "
119464|NCT02003846|"~     There are various methods to generate the pressure needed for Nasal CPAP. Some neonatal~     intensive care units (NICU) use an underwater bubbling system and others use a ventilator to~     generate the pressure. There is no right or wrong way to generate the pressure and both~     methods are approved and accepted.~      The aim of this study is to compare the two systems of Nasal CPAP by placing the baby on each~     for a defined time period and reviewing the infant's vital signs. The investigators expect~     that the pressure generated by bubble CPAP will be better and lead to improved vital signs.~   "
119465|NCT02003833|"~     Anecdotal evidence suggests that patients' skin quality may improve as a result of~     poly-L-lactic acid injection. While this is not the primary goal of such treatments it is~     often seen and described as so called Sculptra glow.~      The aim of this study is to evaluate the effect of repeated subcutaneous injections of~     poly-L-lactic acid (Sculptra Aesthetic) on skin quality.~      Participating subjects will be part of the study for about 15 months. There will be an~     initial treatment period of up to 12 weeks, followed by a 12-month follow-up period. There~     will be a total of 7 scheduled visits.~      This study is a double-blind, randomized study. Double-blind means that neither the~     subjects nor the study doctor will know who is receiving Sculptra Aesthetic or placebo.~     Randomized means that the group subjects will be placed in is decided by chance, similar to~     drawing numbers out of a hat or flipping a coin. Subjects will have a 1 out of 2 chance of~     receiving the active study drug. After the completion of the study, if subjects are assigned~     to the control (placebo) group they will receive free injections with Sculptra Aesthetic same~     as the treatment group.~   "
119469|NCT02003781|"~     Set the prospective cohort (CMERC-HI) to study the known and novel etiologies and related~     factors for predicting clinical outcomes in Korean patients with high risk cardiovascular~     disease.~   "
119470|NCT02003768|"~     The pneumoperitoneum during laparoscopic surgery have the potential to cause an increase of~     intracranial pressure (ICP). Previous studies have proposed that ultrasonographic~     measurements of the optic nerve sheath diameter (ONSD) correlate with signs of increased ICP.~     The aim of this study is to compare the effect of pnemoperitoneum on intracranial pressure~     and cerebral oxygenation during laparoscopic surgery according to anesthesia agents, propofol~     based total intravenous anesthesia (TIVA group) and desflurane anesthesia (Des group).~   "
119471|NCT02003755|"~     Cerebral palsy (CP) is a group of disorders of the development of movement and posture but~     often changing motor impairment syndromes. The spastic subtypes are the most common~     manifestations of cerebral palsy who perform movement difficultly due to hypertonia. Decease~     of spinal cord pathway, hyperactivity of alpha and gamma motoneuron and reduction of~     presynaptic inhibition may cause tendon reflex increase and hypertonia in individuals with~     CP. There are many ways to improve the hypertonia. In the past studies, the fast repeated~     range of motion could reduce muscle's activation effectively. The polyarticular movement~     training might increase joint range of motion and reduce the muscle activation. But the~     polyarticular movement training is difficulty for some individuals with CP. The single joint~     movement training may achieve the same effect as the polyarticular movement training. The~     purpose of this study was to investigate the effects of continuation passive range of motion~     (CPM) training whether could get the improvement of soleus hypertonia in individuals with CP.~   "
119472|NCT02003742|"~     The purpose of the this international, multicenter, randomised, single-blind, parallel group,~     Phase III study is to demonstrate that a single transrectal ultrasound (TRUS)-guided~     intraprostatic injection of NX-1207 provides a long lasting therapeutic improvement of Lower~     Urinary Tract Symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH) in patients~     not adequately controlled by medical therapy with α-blockers, as assessed by a change from~     baseline in the International Prostate Symptom Score (IPSS) total score.~   "
119473|NCT02003729|"~     The SIESTA Home Sleep Study is a pragmatic, multi-centre randomized single-blinded two arm~     trial, assisted by a Decision Analytic Model, primarily designed to assess the accuracy,~     effectiveness and cost-effectiveness of diagnosing OSA assisted by ApneaDx™ as compared to~     PSG as a reference standard.~   "
119474|NCT02003716|"~     The DeFRA questionnaire is a new validated algorithm derived from FRAX. Here we use the DeFRA~     as a primary anamnestic from to identify subjects at risk of osteoporosis in a population~     never screened before and never treated for this disease.~   "
119475|NCT02003703|"~     Hepatitis B virus infection is a common occurrence among patients with HIV. Effective~     vaccines are available, but there's some uncertainty regarding specific dosages, specially~     among those who have not responded to an initial vaccination. The purpose of this study is to~     determine the effectiveness of a simplified immunization schedule compared to a high-dose~     one.~   "
119476|NCT02003690|"~     Of all psychiatric diagnoses, bipolar disorder imparts the greatest risk for completed~     suicide in adolescence, and is further associated with poor psychosocial functioning,~     substance abuse and legal difficulties, and exorbitant healthcare costs exceeding those for~     other adolescent psychiatric conditions. Treatment guidelines indicate optimal management of~     pediatric bipolar disorder includes a combination of medication and psychotherapy. Yet,~     little is known about effective psychotherapy approaches for this population, and none~     expressly target suicidality. An efficacious, cost-effective psychosocial intervention for~     adolescents with bipolar disorder has great potential to decrease the substantial morbidity,~     mortality and costs associated with adolescent bipolar disorder.~   "
119477|NCT02003677|"~     This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetic~     (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the~     investigated drug on the body)properties of FIAsp (faster-acting insulin aspart) in geriatric~     and younger adult subjects with type 1 diabetes.~   "
119478|NCT02003664|"~     This is a Phase II, randomized, double-blind, placebo-controlled study that will examine the~     efficacy of extended-release baclofen (Baclofen ER) for the treatment of cocaine dependence.~     The primary study outcome will be urines positive for benzoylecgonine (BE), a metabolite of~     cocaine, submitted during outpatient treatment (12-week) and follow-up (12-week). To examine~     brain mechanisms of relapse/recovery, participants will complete fMRI sessions before,~     during, and after treatment. Brain responses to specific probes of reward and inhibition will~     be used as biomarkers predicting drug use during and after the treatment.~   "
119479|NCT02003651|"~     The primary objective of this study is to evaluate the effectiveness of ingesting an~     alkylamide-rich echinacea root product (Quick Defense, Gaia Herbs) for 2 days immediately~     following each onset of acute respiratory illness (ARI) symptomatology during a 12-week~     period in the winter and early spring in women.~      Hypothesis: Subjects randomized to Quick Defense compared to placebo over a 12-week period~     will experience reduced ARI symptomatology, both acutely during each ARI episode and~     collectively over the entire 12-week study period.~   "
119480|NCT02003638|"~     This study is looking to see if niacin will lessen atherosclerotic plaque inflammation and~     favorably affect circulating levels of endothelial progenitor cells and microparticles in~     people with atherosclerotic disease on chronic statin therapy.~   "
119494|NCT02003456|"~     Positron emission tomography (PET) scans can be used to evaluate whether parts of the heart~     muscle are alive but receiving inadequate blood supply. This study involves the use of two~     radiotracers that will measure whether heart muscle cell are alive and quantify the blood~     supply to the heart muscle.~   "
119495|NCT02003443|"~     The primary objective of this project is to determine whether self-administered acupressure~     is an effective and feasible self-management strategy for older adults with symptomatic KOA.~     Participants will be randomized to three treatment groups: pain-relief acupressure, sham~     acupressure, and usual care (UC). The two acupressure groups will be taught to administer~     pain-relief and sham acupressure, respectively, on themselves 5 days/week for 8 weeks. The~     usual care group will not be required to change any of their treatment practice. Outcome data~     will be collected at baseline, and the 4th and 8th week after baseline.~   "
119496|NCT02003430|"~     The purpose of this study is to investigate the association between the Independent~     Activities of Daily Living (I-ADL) component of the Comprehensive Geriatric Assessment (CGA)~     and poor tolerance to radiation treatment in older and younger patients with non-ovarian~     gynecological cancers.~   "
119481|NCT02003625|"~     This research study is evaluating a drug called meloxicam to see if it provides a benefit to~     people receiving Autologous Hematopoietic Stem Cell Transplantation (AHSCT).~      The participant is currently scheduled to receive an AHSCT, which is a procedure that removes~     blood-forming stem cells (cells from which all blood cells develop) from the body. These stem~     cells are stored and later given back to the participant by a process called apheresis. This~     is a standard procedure to treat certain blood diseases such as lymphoma and multiple~     myeloma. However the use of meloxicam with this procedure is considered investigational.~      Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) which is given to decrease fever,~     swelling and pain that may come with inflammation. It has been approved by the FDA for the~     treatment of arthritis however it has not been approved for use in people receiving AHSCT.~      This study will compare the combination of meloxicam with a drug called G-CSF (also called~     neupogen), to the combination of G-CSF with an agent that has no medicine (placebo). G-CSF is~     a substance that causes blood stem cells to change or increase in number when given to people~     undergoing AHSCT. The researchers would like to learn if giving meloxicam in combination with~     G-CSF to people before they undergo AHSCT will increase the number of stem cells available in~     the blood to collect and make the collection process easier.~   "
119482|NCT02003612|"~     A retrospective analysis of historical data looking at hematological remission and survival~     in adult relapsed / refractory B-precursor acute lymphoblastic leukemia patients.~   "
119483|NCT02003599|"~     Breast neoplasm is the second most common type in the world. Radiation therapy is a key~     component in the treatment of breast cancer. Acute skin reaction is one of the most common~     side effects of radiation therapy. Several studies were performed for prophylaxis of this~     adverse event, however, until this moment there is no consensus for clinical practice .~     Second meta-analysis , the ideal candidate for the radiodermatitis prevention would be an~     agent capable of repairing damage to DNA or agents that promote cell proliferation . The low~     power laser promotes tissue repair ( reduces inflammatory phase and induces collagen~     synthesis ) . Its use in the treatment of adverse events of cancer treatment is well~     established in two situations : in the prophylaxis and treatment of mucositis and in the~     treatment of lymphedema . The purpose of this study is to use the low power laser in patients~     with breast cancer undergoing radiotherapy treatment to evaluate the effects of Laser InGaAIP~     660Nm in preventing radiodermatitis.~   "
119484|NCT02003586|"~     The study is designed to determine the extent to which foods containing a plant-based~     ingredient affect blood glucose and hormonal response in healthy subjects.~   "
119485|NCT02003573|"~     Dose Escalation (MTD Finding) Phase: To investigate the maximum tolerated dose (MTD), safety~     and pharmacokinetics of different volasertib administration schedules in combination with~     decitabine in previously untreated AML patients >= 65 years of age who are considered~     ineligible for standard intensive therapy, or patients with relapsed or refractory AML~     regardless of prior treatment status.~      MTD Extension Phase: To collect additional data on safety, efficacy and pharmacokinetics of~     volasertib in combination with decitabine in previously untreated patients with AML >= 65~     years of age and considered ineligible for standard intensive therapy.~   "
119486|NCT02003560|"~     The purpose of this study is to determine in a phase II clinical trial whether accelerated~     partial breast irradiation after breast conserving surgery using 3 dimensional external beam~     radiotherapy (3D-CRT) and intensity modulated radiotherapy (IMRT) for low-risk invasive~     breast cancer patients is safe without causing serious late radiation side-effects.~   "
119487|NCT02003547|"~     A Single Centre, Placebo-Controlled, Double-Masked, Sequential Designed Study to Evaluate 3~     Ophthalmic Formulations of AMA0076 in Healthy Subjects~   "
119488|NCT02003534|"~     This study will evaluate 0.15% brimonidine tartrate in patients with primary open angle~     glaucoma and ocular hypertension.~   "
119489|NCT02003521|"~     We hypothesized that the ability of the Lung Flute to enhance mucus clearance from the lower~     airways could be used to improve asthma control, if the device is used on a chronic basis.~     The primary end point of the study is the comparison of Asthma Control Test (ACT) - a~     validated questionnaire for asthma control and exhaled NO before, during and after using the~     lung flute. Several secondary end points were assessed for efficacy and safety, including~     health status, spirometric lung function, stepping down controller therapy and daily~     albuterol use.~   "
119490|NCT02003508|"~     This study will examine how common HPV infection is in teenage males in Australia before and~     after the introduction of universal school based vaccination of males in Australia.~   "
119491|NCT02003495|"~     The purpose of this observer-blind study is to evaluate the safety, reactogenicity and~     immunogenicity of Meninggococcal (A,C,Y and W135) Conjugate Vaccine in 2 months to 6~     years-old children.~   "
119492|NCT02003482|"~     Anatomical changes that take place during Intensity modulated radiation therapy (IMRT)~     treatments for cancers of the head and neck cause significant dosimetric changes.~   "
119493|NCT02003469|"~     Background and Rationale Cardiovascular disease is highly prevalent in the kidney transplant~     population, accounting for approximately 40% of all deaths and significant morbidity. The~     morbidity and mortality experienced by kidney transplant recipient's results from an excess~     of pre-transplant risk factors that are exacerbated by kidney transplantation along with the~     development of novel risk factors. Hypertension (HTN) is the most consistent cardiovascuar~     disease risk factor in transplant recipients..~      A large number of studies have been done in the general population comparing ambulatory blood~     pressure monitoring (ABPM) to casual, office based and home measures of blood pressure (BP).~     The results have clearly demonstrated that ABPM gives a more accurate representation of BP~     and arguably should be used as part of routine patient care. ABPM has been shown to reveal~     patients both with white-coat and with masked HTN, nocturnal HTN and lack of nocturnal~     dipping. Ambulatory BP measures afford us a non-invasive, highly accurate way to evaluate and~     treat kidney transplant recipients.~      Live kidney donors (LKD) have significantly expanded the supply of critical organs. Of~     paramount importance of course has always been donor safety. As a result, candidates are~     known to be healthy at the time of donation. Ambulatory blood pressure monitoring allows a~     unique opportunity to examine the effects of live kidney donation on the blood pressure~     profiles of LKD.~      Methods Study Design: Prospective, 5-year, single center study of ABPM, cardiovascular and~     graft outcomes in incident and prevalent live kidney donors, kidney and kidney-pancreas~     transplant candidates and recipients.~   "
119497|NCT02003417|"~     This study will evaluate the proportion of prostate cancer patients receiving external beam~     radiation therapy (EBRT) and androgen deprivation therapy (ADT) with controlled blood sugars~     (fasting glucose and hemoglobin A1c), blood pressure, and cholesterol profile (total~     cholesterol, LDL, HDL, triglycerides) at baseline, 3 months, and 12 months after completing~     radiation treatment. In addition, receipt of guideline-recommended cardiovascular, primary~     and preventive care as well as patient-reported quality of life and satisfaction with care~     among these patients will be evaluated at baseline and 12 months.~   "
119498|NCT02003404|"~     This purpose of this study is to look at three commercially available ostomy barriers on~     peristomal (around the stoma) skin. Repeated barrier application and removal over years~     causes changes to the skin that the investigators wish to investigate. The primary objective~     is to measure peel force on normal skin and peel force on peristomal skin, with the intent of~     determining if differences occur. The study hypotheses is that no differences exist.~   "
119499|NCT02003391|"~     The purpose of this study is to demonstrate superior intraocular pressure (IOP) control with~     travoprost 0.004% / timolol 0.5% compared to beta-blocker monotherapy in participants with~     open-angle glaucoma or ocular hypertension.~   "
119500|NCT02003378|"~     Some patients' heart rates do not increase as needed during activities and exercise, which~     can make them feel tired and fatigued easily. The patients in this study have a pacemaker~     with a FDA approved rate response sensor, which senses activity level by sensing motion~     (through a component known as an accelerometer) and/or breathing changes (known as minute~     ventilation). These changes in motion or breathing make the pacemaker increase the patient's~     heart rate. This study is being conducted to see which rate response sensor is better (motion~     driven or breathing driven). The study is also investigating whether optimizing the sensor~     based on the individual patient will give better results in terms of increasing the patient's~     exercise capacity. The hypothesis is that rate responsive pacing driven by the minute~     ventilation sensor results in improved functional capacity compared to accelerometer in~     chronotropically incompetent patients.~   "
119501|NCT02003365|"~     The purpose of this study was to characterize the local duration of exposure of TCA for 2~     doses of FX006 relative to 40 mg of TCA IR in patients with OA of the knee.~   "
119502|NCT02003352|"~     Treatment for veterans who have had a traumatic brain injury (TBI) and who are suffering from~     post traumatic stress syndrome (PTSD) is varied with varied outcomes. Investigators will~     study PTSD treatment in military Veterans who have suffered traumatic brain injuries.~     Investigators will use 1 independent specialty treatment centers that utilize a specific~     novel methodology of PTSD treatments and study the clinical outcomes of veterans who have~     suffered a TBI with associated post-concussive symptoms and other comorbidities such as PTSD.~     Investigators hypothesize that the treatment of PTSD will have a significant outcome with~     neurological physical and vestibular rehabilitation when compared to psychological or~     psychiatric therapy. This study will use gold standard measurement scales and compare changes~     in the scales after treatment to evaluate the treatments.~   "
119503|NCT02003339|"~     For patients who are suffering from hepatocellular carcinoma and are treated with~     radioembolization, the purpose of this study is to analyse parameters of functional MRIs that~     are modified early and to detect parameters that vary significantly after treatment.~   "
119504|NCT02003326|"~     The objective is determine the strain measured at the bedside could be a dynamic prognostic~     marker of during Acute respiratory Distress Syndrome (ARDS).~   "
119505|NCT02003313|"~     The purpose of this double-blind study is to evaluate the safety, reactogenicity and~     immunogenicity of Group A,C,Y and W135 Meningococcal Polysaccharide Vaccine in 2 to 30~     years-old Children and Adults. All subjects will receive 1 dose of Group A,C,Y and W135~     Meningococcal Polysaccharide Vaccine.~   "
119506|NCT02003300|"~     The primary aim is to confirm the efficacy of a new non-invasive method for measuring the~     oxygen uptake during general anesthesia of patients undergoing surgery under cardiopulmonary~     bypass. The method has already been successfully tested in the laboratory under controlled~     conditions. In the patient group chosen, oxygen uptake is simultaneously calculated, for~     comparison purposes, from monitoring measurements made routinely as part of normal patient~     care in these cases, using a pulmonary artery catheter - an invasive technique from which~     severe complications occasionally arise, including death.~      A secondary aim is to elucidate the time course of uptake of the anaesthetic vapor,~     isoflurane, during this kind of surgery.~   "
119507|NCT02003287|"~     The main purpose of the study is to determine whether the Fiberoptic Endoscopic Evaluation of~     Swallowing (FEES) is effective in detecting laryngeal penetration and tracheal aspiration~     when compared with the Videofluoroscopic Swallowing Study (VFSS) in bottle-feeding infants in~     the NICU. A secondary objective is to determine whether FEES can be used to detect laryngeal~     penetration and tracheal aspiration in breastfeeding NICU infants.~   "
119508|NCT02003274|"~     BACKGROUND. Optimal glucose control can prevent/relent tissue damage in patients with type 1~     diabetes mellitus (T1DM). Ongoing efforts aim at developing closed loop control (CLC)~     algorithms linking subcutaneous continuous glucose monitoring (CGM) and insulin delivery~     (CSII). Substantial improvement towards an effective artificial pancreas system is still~     needed, especially in the regulation of post-meal glucose. Application of metabolic control~     analysis (MCA) can unveil and quantify distortions in the system properties of the~     glucose-insulin (pump) system (GIS), by measuring the coefficients of control (CCs) of~     glucose. Our approach rely on previous experience with our previous pilot protocol~     (NCT01800734).~      AIM. We will outline and compare features of GIS in T1DM patients and in healthy controls~     during differently sized breakfast meals and during 24-hour periods. The reproducibility of~     our approach will also be assessed.~      METHODOLOGY. Three protocols will be carried out. All T1DM patients will be on CGM/CSII~     therapy. In all three protocols, study 1 will be an euglycemic insulin clamp in T1DM patients~     and a frequently sampled intravenous glucose tolerance test (IVGTT) in healthy controls.~        -  Protocol 1: 10 T1DM patients on CGM/CSII and 10 control subjects will ingest a mixed~          meal of different size (320 and 640 kcal) on two separate occasions.~        -  Protocol 2: 5 T1DM patients will ingest two repeat 320 kcal meals, whereas other 5 T1DM~          patients will ingest two 640 kcal meals on two separate occasions.~        -  Protocol 3: 10 T1DM patients and 10 controls will be monitored for 24 hours, during~          which they will ingest 3 mixed meals.~      Substrate (including CGM)/hormone responses will be measured in all studies. Comprehensive~     single meal and 24-hour models of GIS will be built, MCA will be applied and the CCs of~     glucose assessed, thereby allowing to outline and to compare the CCs of glucose between~     patients and controls.~      EXPECTED RESULTS. Our data will be of use in devising novel clinical strategies in T1DM,~     including, but not limited to, development and refinement of CLC algorithms along the path~     towards an effective artificial pancreas system.~   "
119509|NCT02003261|"~     This study is to examine the superiority of the combined treatments of transdiagnostic~     cognitive-behavior therapy (Unified Protocol; UP) and Treatment-As-Usual in comparison with~     the waiting-list with Treatment-As-Usual in the reduction of depressive and anxiety symptoms~     among depressive and anxiety disorders.~   "
119510|NCT02003248|"~     The proposed study is to evaluate the safety and initial effectiveness of the ExAblate~     Transcranial MRI-guided focused ultrasound (MRgFUS) treatment of patients with dyskinesia of~     Parkinson's Disease (PD)~        -  Safety: To evaluate the incidence and severity of adverse events (AE/AEs) associated~          with ExAblate Transcranial MRgFUS treatment of dyskinesia of PD~        -  Effectiveness: To determine the level of effectiveness of the ExAblate Transcranial~          MRgFUS treatment of dyskinesia of PD.Efficacy will be determined utilizing the UPDRS-IV~          for dyskinesia in PD from examinations at baseline and every 3-Months post-ExAblate~          treatment.~      This study is designed as a prospective, single-site, single arm, nonrandomized study.~     Assessments will be made before and three months after MRgFUS for clinical symptom relief,~     quality of life (QoL) improvements, and safety of MRgFUS in the treatment of LID. Relative~     Safety will be evaluated using a common description of Significant Clinical Complications for~     patients treated in this study. This study will be performed on the 3T MR scanners.~   "
119511|NCT02003235|"~     The study will evaluate the effect of Reviview™, a dichoptic video display device for~     administrating a novel treatment protocol for Amblyopia (lazy eye) in kids.~      The effect of the treatment will be measured by the change from baseline in Visual acuity and~     in Stereoscopic Vision; and to assess the ease of use of and compliance by the patients.~   "
119512|NCT02003222|"~     This randomized phase III trial studies combination chemotherapy with blinatumomab to see how~     well it works compared to induction chemotherapy alone in treating patients with newly~     diagnosed breakpoint cluster region (BCR)-c-abl oncogene 1, non-receptor tyrosine kinase~     (ABL)-negative B lineage acute lymphoblastic leukemia. Drugs used in chemotherapy work in~     different ways to stop the growth of cancer cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as~     blinatumomab, may block cancer growth in different ways by targeting certain cells. It is not~     yet known whether combination chemotherapy is more effective with or without blinatumomab in~     treating newly diagnosed acute lymphoblastic leukemia.~   "
119513|NCT02003209|"~     This randomized phase III trial studies docetaxel, carboplatin, trastuzumab, and pertuzumab~     with estrogen deprivation to see how they work compared to docetaxel, carboplatin,~     trastuzumab, and pertuzumab without estrogen deprivation in treating patients with hormone~     receptor-positive, human epidermal growth factor receptor 2 (HER2)-positive breast cancer~     that is operable or has spread from where it started to nearby tissue or lymph nodes (locally~     advanced). Drugs used in chemotherapy, such as docetaxel, carboplatin, trastuzumab, and~     pertuzumab, work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Giving more than~     one drug (combination chemotherapy) may kill more tumor cells. Estrogen can cause the growth~     of breast cancer cells. Hormone therapy using goserelin acetate and aromatase inhibition~     therapy may fight breast cancer by blocking the use of estrogen by the tumor cells. Radiation~     therapy uses high energy x rays to kill tumor cells. Giving combination chemotherapy and~     radiation therapy with or without hormone therapy may be an effective treatment for hormone~     receptor-positive, HER2-positive, operable or locally advanced breast cancer.~   "
119514|NCT02003196|"~     Morbidity and mortality of ICU patients is increased by the development of a~     immunosuppression systemic (IS). This IS develops in the early hours of hospitalization and~     is responsible for severe infections, including viral reactivations (Cytomegalovirus or~     Herpes Simplex Virus). Viral reactivation was associated with increased morbidity and~     mortality in intensive care units. In clinical practice, they are searched at the onset of~     organ failure or unexplained fever. The investigators wish to conduct this research in the~     stroke patients to assess the predictive power of these viral reactivations on the duration~     of mechanical ventilation.~   "
119515|NCT02003183|"~     The project is designed to assess early diagnosis of Chronic Traumatic Encephalopathy (CTE),~     a neurobehavioral syndrome manifested by failed relationships, marriages, and businesses,~     emotional disturbances, depression, alcohol and substance abuse, and suicide attempts and~     completions. CTE typically begins after a latency period of several years following single or~     repeated Traumatic Brain Injuries (TBIs). A history of cerebral concussion may or may not be~     present.~      This study builds upon prior work at UCLA using Positron Emission Tomography (PET) to~     identify normal and abnormal functional patterns in the brain by studying persons with a~     history of TBI including but not limited to: amateur and professional athletes, active and~     veteran members of the armed forces, as well as victims of motor vehicle and work accidents,~     and physical battery/domestic violence.~      This project aims to expand these findings to the population at large. Identification of the~     syndrome is critical for identifying potential individuals who are most likely to benefit~     from potential prevention and treatment.~   "
119516|NCT02003170|"~     The purpose of this study is to systematically evaluate the results of medical investigations~     to identify symptom and biological patterns and common etiologies of neurodevelopmental~     disorders.~   "
119517|NCT02003157|"~     The purpose of this study is to compare the clinical benefits that can be expected by the~     Embryo transfert procedure with hypnosis to the usual embryo transfer procedure~   "
119518|NCT02003144|"~     The purpose of this study is to determine whether eculizumab long-term use is safe and~     effective in patients with relapsing NMO.~   "
119519|NCT02003131|"~     Allogeneic mesenchymal trophic factors (MTF) from human umbilical cord tissue-derived~     mesenchymal stem cells (UC-MSC) injected into the knee joints of 20 patients (group 1) or~     injected subcutaneously into 20 patients (group 2) is a safe and useful procedure for~     inducing joint function improvements in osteoarthritis (OA) patients with grade 2, 3, or 4~     radiographic OA severity.~   "
119520|NCT02003118|"~     This proof of concept study will be a placebo controlled, randomised, double blind, parallel~     study. The purpose of the study is to determine efficacy for AKR 202 in the treatment of~     osteoarthritis (OA) pain in the knee.~   "
119521|NCT02003092|"~     The purpose of this Phase 2 portion of the study is to use the dose and schedule of RX-5902~     identified in the phase 1 to treat subjects with triple negative breast cancer.~   "
119553|NCT02002676|"~     Patients in critical illness frequently present hypermetabolism， which can extremely increase~     the rest energy expenditure（REE）. We hypothesize that if we alleviate the extremely increased~     REE will improve ICU patients' outcome~   "
119554|NCT02002663|"~     The aim of the study is the identification, comparing continuous infusion of local~     anesthetics and steroids intralesionally with the current gold standard therapy (PCA), of the~     effective dose of local anesthetics and steroids within 7 days following abdominal surgery in~     order to halve the consumption of opioids and give the best pain control with a lower~     incidence of side effects and persistent chronic pain (at 1 and 3 months) We also plan to~     measure the peripheral inflammation and oxidative stress by analyzing the pro-inflammatory~     cytokines and anti-inflammatory properties.~      Another objective is to investigate the combined effect of polymorphisms of genes related to~     pain sensitivity, and the correlation with the development of the inflammatory response and~     the incidence of chronic post-surgical pain (CPSP), which will be considered to validate the~     genotype-phenotype correlations.~      The intralesional catheter will be placed within the operating field by the surgeon at the~     end of the procedure.~        -  first postoperative 24 hours: ropivacaine 0.2%-methylprednisolone 1 mg/kg/die infusion~          (10ml/h) in the wound. Rescue dose with morphine via intravenous PCA (0.5 mg/ml, bolus 1~          mg, lock-out 5 min, max 20 mg in 4 hours)~        -  from 24 hs to 48 hs: ropivacaine 0.2%-methylprednisolone 1 mg/kg/die infusion (10ml/h)~          or saline 0.9% 10 ml/h in the wound. Rescue dose with morphine via intravenous PCA (0.5~          mg/ml, bolus 1 mg, lock-out 5 min, max 20 mg in 4 hours) . from 48 hs to 7th day:~          ropivacaine 0.2% or saline 0.9% via patient controlled intralesional analgesia (PCIA) (2~          mg/ml, bolus 20 mg, lock-out 60 min, max 80 mg in 4 hours). Rescue dose Tramadol 100 mg.~      The first assessment will be by the anesthetist pre-operatively, to verify the patient~     eligibility.~      All patients will be evaluated at the end of surgery (T0) and after 3-6-12-24-36-48 hours~     after surgery. Further evaluations are scheduled every 24 hours until the seventh~     postoperative day. At each assessment will be recorded: Numeric Rating Scale (NRS) at rest,~     NRS at movement (NRSm) - defined as pain at deep inspiration and cough - ; blood pressure,~     heart rate, respiratory rate, nausea (PONV scale), need of rescue analgesics and presence of~     any complications.~      On the 7th postoperative day, the patient will be reassessed by both pain clinicians and~     surgeon; the surgeon will remove the catheter.~      At 1 month and 3 months after surgery, the patient will be evaluated through phone interview~     to investigate pain persistence.~      Inflammatory response analysis will be performed on the first 15 patients in each group (for~     a total of 30 patients). Before awakening of the patient the surgeon will insert a~     microdialysis catheter in the fat adjacent to the surgical wound with sterile technique. The~     microdialysed liquid will be collected in dedicated tubes directly in the infusion pump. The~     sample of the first hour will be discarded to avoid that microtrauma of catheter positioning~     influences the study. Sampling will be performed every 6 hours the first day, and every 12~     hours in the second and third day. Serum samples will be collected to compare systemic with~     regional samples. All samples will be stored at -80 ° C until sampling. Concentrations~     quantification of different cytokines will be analyzed by ELISA Parma Unit will analyze VNTR~     (variable number of tandem repeats) polymorphism of the ADRB2 gene, directly related to the~     risk of chronic persistent postoperative pain development; Pavia Unit will take care of~     genotyping of polymorphic sites in the following genes: OPRM1 (mu-opioid receptor 1), COMT~     (catecholamine O-methyl transferase), UGT2B7 (UDP-glucuronyl transferase), IL1Ra (interleukin~     1receptor alpha). From the blood samples will be extracted DNA and RNA using standard~     procedures. RNA will be retained for possible future studies on the expression of genes of~     interest. The DNA will be used instead for the study of genetic polymorphisms.~      In this study the formation of free radicals, particularly superoxide will be assessed~     together with lipid peroxidation in both serum and urine, The 8- deoxyguanosine and~     Poly-ADP-ribose polymerase (PARP), the presence of nitrotyrosine.~      Blood samples and urine tests will be carried out before the start of surgery , before the~     bolus of morphine and local anesthetic , at 24 h after the end of the intervention and 48 h~     after end of the intervention~   "
119522|NCT02003079|"~     Individuals with Cystic Fibrosis (CF) have a defective protein, which is known as the~     cystic-fibrosis transmembrane regulator (CFTR). The CFTR transports salt and hydrates mucous.~     CFTR defects may result in the accumulation of thick mucous in the sinus cavities. As a~     result, the tiny hair-like structures that sweep mucous out of the sinuses cannot function~     properly, which can lead to recurrent infection and swelling of the sinus walls. When~     symptoms are persistent for more than 12 weeks, this is known as chronic rhinosinusitis~     (CRS). The symptoms that are associated with CRS are nasal discharge, congestion, facial pain~     or pressure and reduced sense of smell. CRS in non-CF patients affects a large number of~     individuals in Canada and has been found to be associated with poor quality of life. In the~     CF population the life expectancy is increasing but chronic disease like CRS is becoming~     increasingly prevalent. Investigators currently do not know the impact that CRS has on the~     health-related quality of life in adults with CF and how many suffer from symptoms. The~     investigators aim to determine the impact of CRS among adults with CF, in order to gain a~     better understanding of chronic disease among these individuals. The investigators strongly~     feel this research will improve the referral processes between Respirologists and~     Otolaryngologists, thereby improving treatment and quality of life for patients.~   "
119523|NCT02003066|"~     Investigators hypothesized that goal-directed fluid therapy using stroke volume variation~     will improve postoperative recovery in patients undergoing free flap reconstruction after~     head and neck cancer resection. Investigators will compare the effect of goal-directed fluid~     therapy using stroke volume variation on recovery in patients undergoing free flap~     reconstruction after head and neck cancer resection.~   "
119524|NCT02003053|"~     Inspiratory muscle training (IMT) is an intervention used with success in the outpatient~     setting within the COPD population. Use of IMT is also theoretically possible during~     mechanical ventilation. This study will will assess the feasibility and safety of the study~     of IMT in the patient population.~   "
119525|NCT02003040|"~     The purpose of this study is to investigate the utility of Venus 1000 in predicting 30-day~     hospital readmissions for acute decompensated heart failure. Secondary outcomes will include~     correlation with NT-proBNP and weight both at admission and discharge from hospital~   "
119526|NCT02003027|"~     The aim of this prospective non-randomized study was to assess the efficacy and safety of~     endomyocardial botulinum toxin injection in left ventricle for preventing episodes of VT~     Storm.~   "
119527|NCT02003014|"~     To investigate the safety and efficacy of long-term treatment with pioglitazone (Actos~     tablets) in combination with biguanides (for 12 months after the start of pioglitazone~     tablets treatment) in patients with type 2 diabetes mellitus.~   "
119528|NCT02003001|"~     The aim of this prospective non-randomized study was to assess the efficacy and safety of~     endomyocardial botulinum toxin injection in left ventricle for preventing ventricular~     arrhythmias.~   "
119529|NCT02002988|"~     The aim of this prospective non-randomized study was to assess the efficacy and safety of~     endomyocardial botulinum toxin injection in projections of main ganglionated plexuses of left~     atrium for preventing drug-resistant paroxysmal atrial fibrillation.~   "
119530|NCT02002975|"~     This study is designed to determine the onset of new cerebral and cardiovascular events and~     changes in metabolic syndrome parameters in patients with type 2 diabetes mellitus on~     long-term pioglitazone (Actos Tablets) treatment.~   "
119531|NCT02002962|"~     The aim of this randomized study was to assess the effectiveness of endomyocardial botulinum~     toxin injection for preventing post-procedural atrial fibrillation in patients undergoing the~     radiofrequency ablation of atrial flutter.~   "
119532|NCT02002949|"~     The purpose of this randomized study is to determine if the home SDHD is a suitable~     alternative to conventional dialysis performed in a dialysis center for patients suffering~     from chronic kidney disease from Peritoneal Dialysis (HAPD/CAPD).~      The adequacy of this alternative dialysis technique confirms that the SDHD at home is a~     viable option for patients coming from HAPD/CAPD and indeed support the clinical benefits of~     home SDHD compared with those of conventional dialysis: lowering blood pressure and lower use~     of antihypertensive drugs , improving the quality of life, maintenance of residual renal~     function related to a reduced risk of death and reduction in operating costs of dialysis and~     patient transport.~   "
119533|NCT02002936|"~     This is an extension study to investigate long term safety and efficacy of SyB C-1101 when~     orally administered every 3 weeks, twice daily for 14 consecutive days to the patients who~     have completed 6 cycles in the study 2012002 whose purpose is to investigate tolerability of~     SyB C-1101 when administered orally in patients with recurrent/relapsed or refractory~     myelodysplastic syndrome.~   "
119534|NCT02002923|"~     The investigators have conducted a prospective, double-blind, randomized study to assess the~     comparative safety and efficacy of two different treatment strategies, PVI only versus PVI~     plus BT injection, in patients with persistent and paroxysmal AF. Results were assessed after~     follow-up of at least 1 years with the use of an implanted monitoring device (IMD).~   "
119535|NCT02002910|"~     To investigate whether instantaneous wave-Free Ratio(iFR)/Fractional Flow Reserve(FFR) guided~     treatment strategy makes the postulated treatment strategy by Coronary Angiogram(CAG) guide~     change and to analyze the cost-effectiveness of its dual diagnosis.~      To investigate difference between SYNTAX score evaluated CAG and functional SYNTAX score~     evaluated physiological assessment of coronary stenosis and its clinical effectiveness.~   "
119536|NCT02002897|"~     The study aims at evaluating the efficacy of the fractional carbon dioxide laser as a new~     modality for treatment of localized scleroderma and to compare its results with the well~     established method of UVA 1 phototherapy.~   "
119537|NCT02002884|"~     The purpose of this study is to determine whether injections of Botulinum toxin type A into~     muscles of one or both arms alone or in combination with injections into one or both legs are~     effective and safe in treating children/adolescents (age 2-17 years) with increased muscle~     tension/uncontrollable muscle stiffness (spasticity) due to cerebral palsy.~   "
119587|NCT02002234|"~     A single-centered, randomized, controlled clinical trial comparing standardized medical care~     alone with standardized medical care and decompressive hemicraniectomy to determine the~     effectiveness of decompressive surgery more definitively in patients with clinical signs of~     infarction of the Middle Carotid Artery (MCA) territory.~   "
119538|NCT02002871|"~     Monocenter, randomized, intraindividual, open label, exploratory study comparing 4 weeks of~     treatment with 453nm blue light with no treatment in patients with Eczema. Patients will be~     screened up to 28 days before start of treatment. During the screening visit, the purpose and~     procedures of the study will be explained to potential patients and informed consent will be~     obtained. In addition, fungal superinfection of the target area will be examined using direct~     preparations and mycology cultures. At the baseline visit, patients with Eczema will be~     determined and all inclusion and exclusion criteria will be assessed. For eligible patients,~     two comparable treatment areas will be randomized to treatment with blue light (target area)~     or to serve as untreated control area. After randomization, patients will receive treatment~     of the target area with 3 applications per week at the investigational site for a total~     treatment period of 4 weeks. During those 4 weeks, safety and effectiveness assessments will~     be performed at weekly intervals. After end of treatment, the patients will be followed-up~     for another 2 weeks. In case no full resolution of adverse events occurred at the 2 week~     follow-up visit, a follow-up call will be performed after another 2 weeks. Treatment~     responses will be photo documented~   "
119539|NCT02002858|"~     The primary aim of this research study is to enhance smoking cessation outcome among smokers~     with elevated anxiety and depression. We are comparing two group treatment approaches: (1) An~     educational-supportive psychotherapy and standard smoking cessation treatment, and (2) An~     integrated smoking cessation, and anxiety and depression management treatment program (SDAT).~     Both treatments also utilize nicotine replacement therapy.~   "
119540|NCT02002845|"~     A retrospective multicenter investigation of the use of the da Vinci® Surgical System in~     Non-Tumor Based TORS Procedures. The study objectives are to evaluate the safety and~     effectiveness of the da Vinci Surgical System in subjects undergoing Benign Non-tumor~     procedures.~   "
119541|NCT02002832|"~     A randomized, double-blind, double-dummy, parallel-group and multicenter study to investigate~     lurasidone in treatment of schizophrenia compared with risperidone~   "
119542|NCT02002819|"~     Patients with Alzheimer's disease (AD) can have seizures in addition to losing their memory~     and other mental functions (referred to as cognitive functions). The seizures, and other~     examples of overactive electrical activity in the brain that is not noticeable, contribute to~     the loss of cognitive function. Studies in animal models of AD suggest that a drug that~     prevents seizures called levetiracetam may reduce neuronal over-excitation and improve~     cognition. Based on this evidence, the investigators propose to determine if levetiracetam~     can be used to treat patients with AD. The investigators developed novel instruments for this~     population that will also be used in future large-scale clinical trials.~      The current study will last for 12 weeks and will involve people with AD. Participants will~     be initially examined with an overnight brain wave study to assess for silent epileptic~     (seizure-like) activity. Presence of epileptic activity on the screening exam is not required~     to enter the trial. Participants will then be assigned to groups in a randomized manner. One~     group will receive levetiracetam for 4 weeks, then no drug for 4 weeks, and then placebo for~     4 weeks. For another group, the order of treatments will be reversed. The cognitive abilities~     of participants will be retested every 4 weeks and compared to those at the beginning. The~     cognitive tests include a virtual-reality navigation test of memory and computerized tests of~     mental flexibility and problem solving. The participants will be monitored with a~     magnetoencephalogram (MEG) with simultaneous EEG (M/EEG) at each visit. M/EEG is a highly~     effective non-invasive method for identifying brain regions of epileptic activity. The~     investigators will need to recruit 36 randomized participants to test the study hypotheses.~     This study will take place at the University of California, San Francisco (UCSF) Memory and~     Aging Center, which is a large referral site for dementias, and the Department of Radiology.~     The overall goal of the study is to demonstrate that levetiracetam provides cognitive benefit~     in AD, particularly in patients who have silent epileptic activity.~   "
119543|NCT02002806|"~     This is a randomized study of surgery plus chemical nerve block versus surgery plus placebo~     for pain control in subjects with pancreatic cancer.~   "
119544|NCT02002793|"~     This study aims to standardized the process of mini-invasive abdominal draniage of SAP in~     early stage.To determine the indications and occasion.~   "
119545|NCT02002780|"~     This research project has two goals. The first goal is to find one or more questionnaires~     that can accurately identify children who are experiencing high levels of stress or emotional~     health issues during a regular clinic visit. The second goal is to find out whether children~     who are experiencing stress or emotional health problems are able to attend a day camp~     programme and complete activities at home that are designed to help them cope better with~     stress. We also want to find out if the day camp and home activities are helpful.~   "
119546|NCT02002767|"~     This study is to evaluate the single-dose pharmacokinetics (PK), safety, and tolerability of~     GS-5816 in participants with severe renal impairment using matched healthy participants as a~     control group.~   "
119547|NCT02002754|"~     This study aim is to observe the response to Bambuterol Hydrochloride tablets treatment in~     subjects with eosinophilic bronchitis .~      The investigators hypothesize:~      A few of subjects with EB have some responses to Bambuterol Hydrochloride tablets therapy.~      Most of subjects with CVA respond well to Bambuterol Hydrochloride tablets therapy~   "
119548|NCT02002741|"~     The purpose of this study is to determine if adding paracetamol to ibuprofen is superior to~     ibuprofen only for treatment of patent ductus arteriosus (PDA) in preterm infants.~   "
119549|NCT02002728|"~     The purpose of this study is to evaluate a methodology for detecting early forming cavities~     in children that is more accurate and reliable than the gold standard used by dentists around~     the world. The new method uses an electrical current device to detect early enamel mineral~     loss before it can develop into a cavity. The manual gold standard is for a dentist to probe~     the surfaces of the teeth with a fine pick, searching for areas of defect.~   "
119550|NCT02002715|"~     This study aims to observe the therapeutic effect of different treatment course with inhaled~     corticosteroids in eosinophilic bronchitis patients.~      The investigators hypothesize:~        1. Cough score will be improved after treatment with longer treatment course with inhaled~          corticosteroids in EB patients.~        2. The sputum eosinophil percentage will be decreased and recovered to normal level~          (Eos%<2.5%) with longer treatment course with inhaled corticosteroids in EB patients.~        3. The rate of recurrence after treatment will be decrease with longer treatment course~          with inhaled corticosteroids in EB patients~   "
119551|NCT02002702|"~     This is a multicenter, randomized, double-blind, placebo-controlled study to assess safety,~     tolerability and pharmacokinetics and to explore efficacy of IV infusion of 10 µg/kg/day and~     30 µg/kg/day serelaxin for 48 hours compared to placebo, when added to the standard therapy,~     in approximately 45 Japanese AHF patients.~   "
119552|NCT02002689|"~     The purpose of this signal seeking study is to determine whether treatment with LDE225~     demonstrates sufficient efficacy in hedgehog pathway-mutated solid tumors and/or hematologic~     malignancies to warrant further study~   "
119555|NCT02002650|"~     Acute pancreatitis is the most common and feared complication of ERCP, occurring after 1% to~     30% of procedures. Since 2012, a multicenter RCT was published in NEJM, indomethacin use in~     high risk patients was considered a standard method to prevent PEP. However, the risk~     factors of PEP is not fully clear. Rectal indomethacin before ERCP for all patients, not just~     for selected high-risk patients, may preventing PEP maximum. The purpose of this study is to~     determine whether routine using of rectal indomethacin is more effective than the conditional~     strategy.~   "
119556|NCT02002637|"~     The objective of this study is to evaluate the safety and technical feasibility of implanting~     the Latella Implant System in the treatment of patients with medial osteoarthritis of the~     knee.~   "
119557|NCT02002624|"~     The aim of this prospective multicenter randomized clinical trial (RCT) is to compare the~     clinical and radiologic results of primary total knee arthroplasty (TKA) using~     patient-specific versus conventional instrumentation.~   "
119558|NCT02002611|"~     The purpose of this study is to evaluate a pharmacokinetic drug interaction between~     lobeglitazone and warfarin in healthy subjects.~   "
119559|NCT02002598|"~     This study is designed to define dose-limiting toxicity and determine preliminary evidence of~     efficacy of Carfilzomib (CFZ) in combination with bendamustine and dexamethasone for patients~     with newly diagnosed multiple myeloma (MM).~   "
119560|NCT02002585|"~     Kidney protection study (KPS 1) is a prospective randomized clinical study comparing the use~     of renal denervation (RDN) and optimal medical therapy in subjects with chronic kidney~     disease stage 3-4 and resistant arterial hypertension to optimal medical therapy alone. Renal~     denervation is a modern endovascular method used to treat resistant hypertension. The method~     is being extended to other groups of patients, where the sympathetic tone is increased beyond~     resistant hypertension. Because of the character of the disease, we hypothesize that renal~     denervation can reduce or prevent progressive deterioration of kidney functions in this~     patient population. The aim of this clinical study is to show that renal denervation has~     protective effects on the progression of chronic renal insufficiency.~   "
119561|NCT02002572|"~     The SIMOVI project is a collaboration between our Department of Maxillofacial Surgery (CHU~     Amiens) and the Biomechanical bioengineer Research Department and Roberval Labs~     (Technological University of Compiègne). The question raised is the extent to which a facial~     mimic can be evaluated objectively. In today's clinical practice, the investigators use~     grading systems based on muscular scale or testing, in order to evaluate a facial muscular~     disorder. This assessment remains subjective because the investigators are deducing from~     surfacing cutaneous deformations the movement quality of the solicited muscle.~      This qualitative approach is therefore an approximate approach and deserves to be better~     thought to plan a surgical treatment which involves mimic facial muscle (as rehabilitation of~     facial palsy, cleft palate for example), to monitor the results, and to follow the recovery~     and progress in physiotherapy care.~      The aim of this study is to correlate external soft tissue movement (essentially cutaneous)~     during facial mimic with internal movement (essentially facial mimic muscle) using~     qualitative and QUANTITATIVE indicators, and to perform a biomechanical model of selected~     mimic face's movement using the precedent data.~   "
119562|NCT02002559|"~     This study aimed to compare Narrow Band Imaging (NBI) against Lugol chromoendoscopy for~     diagnosis of early esophageal cancers among high risk patients.~   "
119563|NCT02002546|"~     1. In chest pain patients with suspected acute coronary syndrome, a 2-hr delta Troponin-I~          as measured by the i-STAT immunoassay reliably identifies and excludes an acute~          myocardial infarction.~        2. In chest pain patients with suspected acute coronary syndrome whose baseline troponin is~          above the 99th percentile but less than 0.2ng/ml, a 2hr delta Troponin-I as measured by~          the i-STAT immunoassay accurately discriminates between acute myocardial infarction and~          non-acute myocardial infarction troponin elevations.~   "
119564|NCT02002533|"~     This randomized phase II trial studies how well brief behavioral therapy works in improving~     sleep disorders in patients with stage I-III breast cancer undergoing chemotherapy. Sleep~     disorder counseling may reduce fatigue and insomnia as well as improve the well-being and~     quality of life in patients with breast cancer who are undergoing chemotherapy.~   "
119565|NCT02002520|"~     Pain is the way our brain interprets certain bodily sensations. It is very difficult to~     describe or to put into words as perception and tolerance of pain varies widely between~     individuals. It is known that age, gender and past experience and memory of past experience~     all contribute to patients' feelings of discomfort and tolerance of pain, but the reason why~     some patients actually do not experience any pain at all post surgery is still unknown.~      Because pain affects every person at some point in their lives, it is of utmost importance~     that we can find more effective analgesic methods, and provide analgesia tailored to an~     individual's need as well as discovering new methods which may be able to identify those~     individuals who are more prone to suffering serious, or chronic pain. It has been proposed~     that epigenetic modifications may play a role in sensitivity to analgesia and response to~     trauma, such as post surgery. The effects of epigenetic changes on key genes and the role~     this plays in analgesia sensitivity and pain perception is deserving of further research.~      Epigenetics is a growing field of study in which there are genetic modifications that do not~     involve changes to base sequences in a gene, but that result nonetheless in changes to gene~     expression. It has long been known that changes in gene expression play an important role in~     the establishment of pain states. But it is not known whether a priming injury can induce~     lasting epigenetic marks which would result in an increase in both postoperative acute pain~     and the risk for chronic pain. Only by fully understanding these epigenetic mechanisms will~     we be able to offer better drugs for the treatment of pain, and to identify those at high~     risk of postoperative pain and postsurgical chronic pain.~      The purpose of this study is to determine whether severity of pain following surgical~     procedures, such as third molar surgery is related to baseline methylation status of the~     promoter region of IL-6 and TNF-α and changes in methylation status post surgery.~   "
119566|NCT02002507|"~     Our hypothesis is that there will be a decrease in internal jugular venous flow in the park~     bench position when compared to the supine position. There will also be a change in blood~     flow between the right and left internal jugular veins in the park bench position. In~     particular, there will be a greater reduction of flow on the dependent side. However, the~     internal jugular venous flow will be the same in both the prone and supine positions.~   "
119567|NCT02002494|"~     Our hypothesis is that there will be a decrease in internal jugular venous flow in the park~     bench position when compared to the supine position. There will also be a change in blood~     flow in the between right and left internal jugular veins in park bench position,~     particularly there will be a greater reduction of flow on the dependent side. However, the~     internal jugular venous flow will be the same in both the prone and supine position.~   "
119568|NCT02002481|"~     Investigation of the influence of narrowness and unusual circumstances on the CPR-quality~   "
119569|NCT02002468|"~     Denmark has a higher incidence of cervical cancer than other Nordic countries, although all~     Danish women (aged 23-65) are screened regularly to identify possible cervical dysplasia or~     asymptomatic invasive cancer.~      Annually 40 000 women receives an abnormal or inadequate test result and a follow-up~     recommendation.~      However problems with delayed follow-up may threaten the effectiveness of the Danish Cervical~     Cancer Screening Program, as 20% of women are delayed and dysplasia potentially can progress~     into cancer.~      Delayed follow-up is found in situations where women either consciously or unconsciously~     postpone follow-up, or because of organizational aspects of the screening program, where~     communication regarding test results can fail either in content or with delay.This study will~     evaluate two interventions designed to increase follow-up:~        1. A letter with the test result and potential recommendation for follow up will be sent to~          the women (RCT). The intention is to ensure that all women will be notified about the~          test result, quickly, homogenously and in layman's written language, still with the~          opportunity to contact or be contacted by the general practitioner, if there is special~          needs. Furthermore, it is assumed that general practitioner consultations regarding~          delivery of normal test results will decrease, so that cost savings is a potential side~          benefit~        2. Electronic reminder to the general practitioner if women have not had the recommended~          follow up, giving the general practioner´s an opportunity to remind the women (retro~          perspective cohort study).~      The results will be of great importance to the future organisation of cervical and colorectal~     cancer screening programmes in Denmark, but will also have international interest because of~     their similar challenges.~   "
119570|NCT02002455|"~     Prostate cancer (PCa) is currently the most common neoplastic disease among men in~     well-developed countries with 350 000 new cases diagnosed annually in Europe and 4 800 in~     Finland. Due to widespread use of serum prostate specific antigen (PSA) in asymptomatic men,~     most patients present initially with localized disease. Radical prostatectomy, radiotherapy~     (RT) and active surveillance are the most common management options for patients with~     localized PCa. Proper preoperative staging for patients with adverse features on biopsy who~     are candidates for radical prostatectomy is urgently needed. For elderly men external beam RT~     is the preferred modality which can be safely performed utilizing modern techniques such as~     intensity modulated and image guided radiotherapy (IMRT and IGRT). Since randomized studies~     suggest a dose response effect beyond 78-80 Gy newer techniques aim at dose escalation~     provided that toxicity can be controlled. Therefore, ultra high dose IMRT/IGRT requires~     visualization of intracapsular disease which will receive the highest dose. Taken together,~     the use of accurate anatomical and functional imaging modalities are essential for planning~     both nerve sparing radical prostatectomy and ultra high dose IMRT/IGRT Fluorine-18 labeled~     L-leucine analogue 1-amino-3-fluorocyclobutane-1-carboxylic acid (FACBC) has shown to~     preferentially accumulate in PCa and its nodal metastases. By assisting in localization of~     intraprostatic and pelvic disease FACBC with hybrid positron emission tomography/computed~     tomography (PET/CT) or magnetic resonance imaging (PET/MRI) has potential to improve~     selection of patients for robot-assisted radical prostatectomy and IMRT/IGRT.~      Anatomical MRI at 1.5 Tesla (T) compared with transrectal ultrasound has demonstrated a~     higher sensitivity for tumor detection but almost the same specificity, stressing the need~     for additional metabolic MRI. Advanced application of MRI such as proton magnetic resonance~     spectroscopy (1H MRS), diffusion weighted imaging (DWI) and dynamic contrast enhanced imaging~     (DCE-MRI) are increasingly being used for detection and characterization of PCa. The use of~     3T scanners and multiparametric MRI (mpMRI), consisting of anatomical MRI, DWI, 1H MRS and~     DCE-MRI, demonstrated very promising result for staging and detection of PCa.~   "
119571|NCT02002442|"~     The primary aim of this study is to evaluate and compare the efficacy of a 60 second rinse~     with chlorhexidine, essential oil-based mouthwash, cetylpyridinium chloride mouthwash, or~     saline solution on bacterial contamination in the buccal vestibule when used preoperatively~     using the real-time Polymerase Chain Reaction (qPCR).~      We hypothesize that preoperative rinse with chlorhexidine mouthwash will result in greater~     reduction of bacterial counts than with essential oil-based, cetylpyridinium chloride, or~     saline mouthwashes.~      The secondary aim of this study is to evaluate the effect of the tested mouthwashes in~     reducing the bacterial counts over time.~      We hypothesize that preoperative rinse with chlorhexidine mouthwash will result in a~     reduction of bacterial counts for longer duration than with essential oil-based,~     cetylpyridinium chloride, or saline mouthwashes.~   "
119572|NCT02002429|"~     Background: Facet interventions are the second most commonly performed procedure in pain~     clinics throughout the U.S, including in the military. Currently, there is no clear consensus~     regarding whether intra-articular (IA) blocks or medial branch blocks (facet joint nerve;~     MBB) are the best way to diagnose and treat facetogenic pain, or even whether or not to~     perform diagnostic/ prognostic blocks.~      Hypothesis: IA blocks will provide better relief than MBB, but MBB may better select patients~     for radiofrequency denervation.~      Purpose: Objective 1: Determine which prognostic block is the best predictor for RF~     denervation outcome; Objective 2: To determine whether adding steroids to IA or MBB may~     provide intermediate or long-term benefit to a subset of individuals.~      Research Design: Randomized, comparative-effectiveness study~      Methodology /Technical Approach: A total of 225 patients with non-radicular chronic low back~     pain (LBP) with suspected facetogenic etiology will be randomized in a 2:2:1 ratio to one of~     3 groups:~      Group 1 will receive IA blocks with steroids and LA Group 2 will receive MBB with steroids~     and LA Group 3 will receive MBB with only saline~      Those individuals who obtain significant (≥ 50% in groups 1 and 2,3) but temporary (<~     1-month) relief will undergo radiofrequency (RF) denervation at their 1-month follow-up. In~     group 3, those patients who do not experience pain relief at 1-month will undergo RF~     denervation regardless of the pain relief they experience (as many practitioners in the~     military and civilian practices do without diagnostic blocks).1-3 Participants in Groups 1~     and 2 who experience prolonged relief from their diagnostic/ therapeutic blocks with LA and~     steroids will not undergo RF denervation until their pain returns. Those individuals who~     experience prolonged relief lasting > 6 months will be given the option of repeating the~     diagnostic/ therapeutic block. In Groups 1, 2 and 3 patients who experience prolonged relief~     from the diagnostic blocks, follow-up visits will be at 1-month, 3-months and 6-months after~     the block, or until their pain relief wears off. In those who undergo denervation based on a~     positive block, follow-ups will be performed 1, 3 and 6-months after the denervation provided~     they continue to experience significant (> 50%) relief at each follow-up. Those individuals~     who fail to experience significant relief after denervation will be unblinded and exit the~     study per protocol.~   "
119573|NCT02002416|"~     The MET oncogene encodes the receptor tyrosine kinase (RTK) for hepatocyte growth factor~     (HGF) and controls genetic programs leading to cell growth, invasion and protec¬tion from~     apoptosis. Although the definitive role of MET oncogene is yet to be determined in~     carcinogenesis of gastric cancer, overexpression and amplification of c-Met has been~     demonstrated in gastric cancer cell lines. In addition, approximately 10-20% of gastric~     cancer tissues and up to 40% of the scirrhous histological subtype were shown to harbor~     increased MET gene copy numbers. Importantly, PHA-665,752, a selective c-Met kinase inhibitor~     showed significant reduction of established tumor mass in mouse xenografts with GTL16, a~     gastric cancer cell line with >10-fold MET amplification. Another pivotal study showed that~     gastric cancer cells with MET amplification were extremely sensitive to PHA-665,752 and~     implicated a potential role of c-Met protein in developing theranostics in gastric cancer.~     More and more data indicated that c-Met was an important prognostic factor in gastric cancer.~      Gastric cancer is a heterogeneous disease. Does the expression and amplification of c-Met in~     the primary lesion differ from the metastatic disease? Does the expression and amplification~     of c-Met in the early disease differ from advanced disease? Till now there is no related~     report.~      Purposes:~        -  Compare the expression and amplification of c-Met between primary lesion and metastatic~          lesion together with clinical characteristic, to explore the relationship of c-Met~          expression and metastatic pattern~        -  Compare the expression and amplification of c-Met between early stage and metastatic~          stage, and to explore the role of c-MET in the development of carcinoma~   "
119792|NCT01999569|"~     The purpose of the study is to establish that sustained estrogen levels are the driving force~     for the LH surge, and are thereby necessary for ovulation to occur. We predict that by~     reducing levels of circulating estrogen, letrozole, an aromatase inhibitor, will inhibit~     ovulation from occurring.~   "
119574|NCT02002403|"~     The drug being tested in this study is low doses of Optina (formerly known as Danazol)~     (DMI-5207) that may be an effective treatment for diabetic retinopathy and diabetic macular~     edema (DME). Laboratory studies have demonstrated that low doses of this drug may treat~     diabetic retinopathy and diabetic macular edema by two important ways, decreasing blood~     vessel permeability (related to leaking and edema) and by decreasing the formation of new~     leaky blood vessels. Optina is not approved by Health Canada for the treatment of diabetic~     macular edema but higher doses of Optina are approved by Health Canada for treatment of~     endometriosis (growth of cells similar to those that form inside of the womb that grows~     outside of the womb) and fibrocystic breast disease (a condition of the breast tissue).~     Higher doses of Optina have also been approved in the United States and many other countries~     since the mid-1970s in the treatment of men and women with hereditary angioedema (a disease~     which causes swelling in parts of the body) in addition to endometriosis and fibrocystic~     breast disease in women.~      All of the Optina doses that will be used in the current study are less than half of the~     typical starting doses for the approved indications. This can be compared to high-dose~     aspirin that is used to treat, for example, headache, while low-dose baby aspirin is used~     to reduce blood clotting. Similarly, Optina has two different effects at high and low dose.~     The low doses for this study have been selected based on the laboratory studies mentioned~     above.~      The purpose of this study is to investigate the safety and effectiveness of low doses of~     Optina in the treatment of macular edema due to diabetes, and also to test if it helps to~     slow the development of macular edema.~   "
119575|NCT02002390|"~     Stroke is one of the main severe disease of public health importance. Increasing evidence~     suggests that inflammatory mechanisms plays a significant role in stroke. So, immune targets~     are supposed to be an effective one. The sphingosine-1-phosphate receptor regulator~     Fingolimod(FTY720)is an effective immunology modulator which has been widely used in~     autoimmune disease and has been testified effective on stoke animal models.~   "
119576|NCT02002377|"~     SHIFT-2 is a national, multi-center, non-randomized, open label trial of aflibercept in~     patients with wet age related macular degeneration who have incomplete response with~     routineranibizumab treatment.~   "
119577|NCT02002364|"~     In patient who are predicted to be difficult to intubate with a standard direct laryngoscope~     well use flexible optical intubation via a supraglottic airway devise (the Ambu Aura-i).~     Patients are randomly assigner to a single- or a multiple- use flexible optical scope.~      We hypothesize that intubation is obtained equally effective with both types of flexible~     scopes~   "
119578|NCT02002351|"~     This monocentric registry should provide information on the extent how patients with~     pulmonary diseases such as pulmonary hypertension will benefit from rehabilitation treatment.~     The data may provide a basis for further prospective studies showing the treatment of~     patients with pulmonary diseases especially by physical activation.~   "
119579|NCT02002338|"~     A study to research the post-operative results according to the chosen surgical technique and~     evaluate the refractive changes before and after the excision of pterygium.~   "
119580|NCT02002325|"~     The purpose of this study is to clarify efficacy and safety of MRI-based intravenous~     thrombolysis with alteplase for patients with acute wake-up ischemic stroke and those having~     acute ischemic stroke with unknown time of symptom onset.~   "
119581|NCT02002312|"~     To determine the efficacy of multiple doses Lutetium-177-DOTA-girentuximab in patients with~     advanced clear cell renal cell carcinoma using RECIST criteria.~   "
119582|NCT02002299|"~     The purpose of this study is to investigate the invasive front in growth mode (expanding or~     infiltrative) and dedifferentiation (tumor budding) and comparing these with the tumor~     surface (polypose or flat) + / - ulceration in surgical specimens at colorectal cancer.~   "
119583|NCT02002286|"~     This study is a pilot study to evaluate impact of Tripterygium Wilfordii Hook F (TwHF) on T~     cell immune activation and immune activation in HIV-infected immunological non-responders.~     The investigators aim to evaluate the safety and efficacy profiles of TwHF in HIV~     immunological non-responders.~   "
119584|NCT02002273|"~     The objective of this randomized study is to compare the effect of two controlled chest tube~     protocols on the duration of air leak and fluid drainage following pulmonary lobectomy or~     segmentectomy by using an electronic regulated chest drainage system (Thopaz). Previous~     studies have suggested that the amount of negative pressure used at the level of the chest~     drainage device may affect the duration of air leak, but the results have been inconsistent,~     however as revealed in more recent studies understanding of the physics of chest drainage~     devices may have been confounded by lack of regulation of the pleural pressure.~      In addition, experimental studies have shown that fluid drainage may be affected by the~     degree of negative pleural pressure applied.~   "
119585|NCT02002260|"~     This study is a randomized clinical trial comparing the levonorgestrel intrauterine system~     (LNG-IUS) to combined oral contraceptives (COCs) for treatment of heavy menstrual bleeding.~     This study is designed to be conducted within the context of a patient's~     standard/usual/typical care from their primary gynecologic care provider. We hypothesize~     that, compared to COCs, the LNG-IUS will be more effective at improving bleeding-related~     quality of life and will be associated with fewer treatment failures and greater~     cost-effectiveness at one year. To test these hypotheses, we plan to enroll 59 women from~     several sites who present for gynecologic care and self-report heavy menstrual bleeding into~     a RCT comparing LNG-IUS to COCs. The eligible study population includes women with heavy~     menstrual bleeding secondary to ovulatory disorders (AUB-O) or endometrial hemostatic~     disorders (AUB-E). Women meeting study eligibility will be randomized to receive LNG-IUS or~     COCs. Main study outcomes will be obtained at 6 weeks, 3 months, 6 months, and 1 year.~   "
119586|NCT02002247|"~     The aim of the investigators' research program is to investigate the effects of perioperative~     high dose selenium supplementation in high-risk cardiac surgical patients undergoing~     complicated open heart surgery. The investigators hypothesize that the therapeutic strategy~     tested in this randomized trial may contribute to a fewer complications, less organ injury~     and fewer deaths. Before the investigators conducted the large definitive trial, they~     conducted a pilot study to assess the feasibility of the protocol, and are rolling the pilot~     patients into the definitive trial.~   "
127316|NCT01900938|"~     The aim of this study is to compare sedation efficiency, safety and satisfaction by both~     endoscopist, assistants, and the patients between continuous infusion and intermittent bolus~     injection of propofol for deep sedation during ERCP.~   "
119588|NCT02002221|"~     The purpose of this study was to assess the efficacy and safety of vildagliptin 50 mg bid~     add-on therapy to improve overall glycemic control in patients with T2DM inadequately~     controlled by insulin, with or without concomitant metformin treatment. It was agreed with~     PMDA to conduct a postmarketing clinical trial to further collect the efficacy and safety~     data of vildagliptin especially in Japanese patients when it iwas used on top of insulin.~   "
119589|NCT02002208|"~     The purpose of this study is to determine whether OC000459 is in reducing disease severity~     and preventing flares in people with moderate to severe atopic dermatitis (AD).~   "
119590|NCT02002195|"~     Elderly patients are generally underrepresented in the study populations of combination~     chemotherapy trials. In gastric cancer patients, oxaliplatin has shown a more favorable~     toxicity profile than cisplatin. A combination chemotherapy of 5-fluorouracil (5-FU) with~     oxaliplatin, mainly FOLFOX regimens, has been investigated in numerous phase II studies,~     using different doses and schedules, and has shown considerable antitumor activity. Insofar~     as toxicity is concerned, significant toxicities, including myelo-suppression and peripheral~     neuropathy, are a major issue for elderly patients. A modified FOLFOX regimen by omitting the~     administration of bolus 5-fluorouracil have shown a good profile of activity and tolerability~     in the elder population. This study evaluates the efficacy and safety of a modified FOLFOX (m~     FOLFOX) regimen for up to 8 cycles followed by capecitabine maintenance in elderly patients~     with metastatic gastric cancer and presenting associated disease(s)~   "
119591|NCT02002182|"~     Some cancers may be related to an infection with a virus, such as the Human Papilloma Virus~     (HPV). HPV related Oropharyngeal cancer (HPVOPC) accounts for 80% of oropharynx cancer cases~     in the United States. HPVOPC has better prognosis than patients with HPV negative oropharynx~     cancer. In many hospitals, the standard of care treatment for oropharyngeal cancer is surgery~     and/or radiotherapy with or without chemotherapy. While chances of survival for most patients~     with HPVOPC is very good, current treatments are associated with short- and long-term side~     effects which can be severe. In pre-clinical research using animal models of cancer,~     vaccination targeting the HPV virus has been found to cause tumor regression. Thus,~     approaches which target the unique characteristics of HPV-infected cancer cells, such as~     therapeutic vaccination, are attractive strategies for potentially reducing radiotherapy and~     chemo radiotherapy regimens (and thus decreasing toxicity) and enhancing long-term disease~     control.~      The purpose of this study is to see if an experimental vaccine, ADXS11-001, is effective in~     stimulating the body's defense system against HPV-positive oropharyngeal squamous cell~     carcinoma before transoral (through the mouth) surgery. The experimental product ADXS11-001~     uses a live strain of the Listeria monocytogenes (Lm) bacteria that has been genetically~     modified such that the risk of getting an infection is significantly reduced. Several~     research studies have already been conducted with ADXS11-001 in men and women with cancer. So~     far, approximately 722 doses of ADXS11-001 have been given to 290 patients with HPV~     associated cancers.~   "
119592|NCT02002169|"~     Background: The investigators developed a Shower Technique protocol (STP) for hemodialysis~     (HD) patients with healed central venous catheter (CVC) exit sites, designed to permit~     showering but not increase infection risk.~      Research question: Is it feasible to conduct a randomized control trial comparing the rate of~     CVC related bacteremia (CRB) in adult satellite HD patients using STP versus standard CVC~     care alone with 6 month follow up? Study Design: This pilot study is a multi-centre~     randomized control trial. Eligible participants will be randomized to STP versus standard~     care after meeting predefined criteria to confirm healed tunneled CVC exit site.~      Primary Outcome: Feasibility will be determined based on 5 outcome measures: accuracy of the~     CRB rate documentation in the satellite setting, percentage of patients screened, recruited,~     educated successfully in the STP (intervention arm), and aspects of STP (% of contaminated~     patients in the control arm).~      Study Setting: In satellite units affiliated with 2 academic and 3 community centres in south~     central Ontario, Canada.~      Patient Population: Adult satellite HD patients dialyzing via CVC with healed CVC exit sites.~      Intervention: STP and standard CVC care; or Control: standard CVC care; Analysis: Each~     measure of feasibility has its statistical threshold for success. If the threshold is reached~     in 4 of the 5 measures, the full HIPPO SAT study will be deemed feasible.~      Discussion: A pilot feasibility study of the larger study is critical due to the potential~     challenges associated with recruitment, compliance and contamination.~   "
119593|NCT02002156|"~     The Bacille Calmette-Guérin (BCG) vaccine is the only vaccine licenced to prevent~     tuberculosis (TB). The stimulus it gives to the immune system allows it to respond more~     effectively to a subsequent infection with TB.~      Many studies have shown that BCG is effective in reducing deaths from TB disease,~     particularly in children. However, there is also evidence that in countries with a relatively~     high death rate, BCG reduces this death rate but by more than would be expected by its effect~     on TB alone. This controversial but important finding warrants further and serious~     consideration. One possibility is that BCG, in addition to stimulating the immune system~     against TB, also has a positive effect on the way the immune system works more generally.~     This might mean a more effective response to serious infections that are completely unrelated~     to TB, or the ability to respond better to other routine childhood vaccines, or to maintain~     such responses for longer. In these examples, the timing of BCG administration in relation to~     other vaccines could be crucial.~      This study will recruit 30 healthy babies who would not routinely be offered the BCG vaccine~     in the UK within the first week of life. Babies will be assigned at random to one of three~     groups of ten babies each. BCG will be given to one group of babies around birth, one at~     three months old and the last group will not get BCG during the study. Babies will stay in~     the study until 13 months old and have five blood tests over this period.~      This preliminary study will look at the participants' blood to see if there are differences~     in the immune system, or its response to the MenC childhood meningitis vaccine or the pattern~     of genes activated after BCG has been given.~   "
119643|NCT02001506|"~     Various regimens and schedule as neoadjuvant chemotherapy regimens were investigated and~     sequential treatment of anthracyclines followed by taxanes, which has shown superior~     pathologic complete respone (pCR) rate (NSABP-B27 study) is widely used until now.~     Considering the proven efficacy and tolerable toxicity of 3 cycles of FEC followed by 3~     cycles of Docetaxel (FEC3-D3) compared to FEC 6 cycles in adjuvant chemotherapy (PACS 01~     trial), use of FEC3-D3 regimen in neoadjuvant setting will be feasible with acceptable~     efficacy and further reduce the duration of neoadjuvant chemotherapy.~   "
119594|NCT02002143|"~     Type 2 diabetes is a major problem of older people; its prevalence is greater than 20% in~     those aged over 65 years. Treatment such as medication, healthy nutritional choices & body~     weight management, as well as physical activity can reduce the impact of diabetes.~      Older patients with type 2 diabetes can potentially benefit from Group Appointments, in which~     8-12 patients share one appointment of about 60-120 minutes with a team of health~     professionals.~      The team of investigators (3 people) will see the 'Group' 4 times/yr for two years. Their key~     measure of success will be control of glycosylated hemoglobin - HbA1C.~      To address their primary and secondary research objectives the investigators will focus upon~     patients aged 65 years or older who have T2DM and who are being treated with oral~     hypoglycemic agents and diet, or diet alone.~      The investigators will compare patients randomized to (A) eight Group Appointments over a 24~     month period (i.e., 4 per year), led by a primary care physician [Intervention] with, (B)~     patients randomized to eight traditional one-to-one usual care appointments also provided by~     a primary care physician (Individual Appointment; [Control]). The investigators will compare~     (A) and (B) on selected clinical, patient-rated, and economic outcome measures.~      SIGNIFICANCE: Seven Canadian provinces already have Group Appointment billing codes for~     physicians who lead Group Appointments. If the study's proposed health care innovation~     demonstrates benefits, it would be possible to 'roll out' / 'scale up' the model province- or~     nation-wide in Primary Care settings.~   "
119595|NCT02002130|"~     Type I Diabetes is an auto immune disease in which the body's immune system attacks and~     destroys the insulin-producing beta cells of the pancreas. Therefore, children affected by~     this condition present with high blood sugars. This condition affects 1:400/500 persons~     worldwide.Type I Diabetes, previously known as Juvenile Diabetes,usually strikes in~     childhood, adolescence, or young adulthood, but lasts for a lifetime. To date, there has been~     no treatments that can arrest, or reverse the ongoing beta cell destruction. We hypothesize~     that GABA, a naturally occurring substance, has the potential to reduce the inflammation and~     protect the pancreatic beta cells from autoimmune destruction. GAD-alum may contribute to the~     preservation of residual insulin secretion in patients with recent onset, Type I Diabetes.~   "
119596|NCT02002117|"~     The logical next step is to integrate molecular profiling into the care of all patients with~     NSCLC.~   "
119597|NCT02002104|"~     The replacement of autologous blood vessels by artificial grafts is urgently needed in~     clinical applications. Expanded polytetrafluoroethylene (ePTFE) grafts are the most~     clinically used artificial blood vessels because of its chemical and mechanical stability.~     But, when used as arteriovenous (AV) grafts for haemodialysis, small diameter ePTFE grafts~     have a high failure rate of 40% in three years in vivo because of the functional lack of an~     intact endothelial cell layer. Here we developed a two-step modification including chemical~     etching and plasma activation to enhance the hydrophilicity of ePTFE. Peptide motifs (eg.~     cyclic RRE, RGD) known to bind integrins on the endothelial cells were immobilized on ePTFE~     grafts. Functional peptide immobilization significantly increased the adherence and growth of~     HUVEC cells on ePTFEs. Patch ePTFE implantation in the pig's descending aorta was used to~     evaluate the in vivo endothelialization of these modified ePTFE grafts. At 28 days~     implantation, newly formed endothelial layers on peptide-immobilized ePTFE grafts were~     demonstrated by SEM and histological analysis. These preliminary data showed the potential to~     grow an intact endothelial layer to improve the patency rate of the modified ePTFE grafts.~   "
119598|NCT02002091|"~     -  It is a prospective,observational, cohort study~        -  The main purpose of the study is to assess the prevalence of diabetic chronic~          complications in newly diagnosed type 2 diabetics in suburban area of Algiers.~        -  The secondary purpose is to study the impact of diabetic renal complications as a risk~          factor on the atherothrombotic events.~   "
119599|NCT02002078|"~     Corrosive substance ingestion in childhood is a public health issue in developing countries~     and several management protocols were proposed to prevent esophageal strictures. The role of~     corticosteroids in preventing corrosive-induced strictures is controversial. The~     investigators' aim is to study the influence of high doses of corticosteroids to prevent~     esophageal strictures.~   "
119600|NCT02002065|"~     The purpose of this follow-up study is to evaluate the five-year immune persistence of one~     injection of inactivated and attenuated alive hepatitis A vaccine in healthy children.~   "
119601|NCT02002052|"~     Concurrent chemoradiotherapy is the standard treatment for locally advanced, unresectable~     non-small cell lung cancer, but carries a risk of radiation pneumonitis of approximately 30%,~     and is associated with a decline in pulmonary quality of life.~      Standard radiation planning aims to optimize dose to the anatomic lung volume, without~     consideration of the differences in regional lung function. Functional lung avoidance~     radiotherapy aims to reduce radiotherapy dose to regions of functioning lung, instead~     depositing dose in areas of lung that are not well-ventilated. Functional lung regions are~     determined using noble-gas MRI and co-registered to the radiotherapy planning CT scans.~     Functional lung avoidance radiotherapy has been demonstrated to be feasible, and this trial~     aims to compare outcomes between standard radiotherapy (with concurrent chemotherapy) vs.~     functional lung avoidance radiotherapy (with concurrent chemotherapy).~   "
119602|NCT02002039|"~     Whether Erythropoietin improves the neurological outcomes of neonates with perinatal~     asphyxia.~   "
119603|NCT02002026|"~     This trial will address the effect of uterine artery ligation during Cesarean section in~     cases with placenta previa to decrease blood loss.~   "
119604|NCT02002013|"~     Translating reliable evidence on fluid resuscitation of intensive care patients into clinical~     practice - Improving patient outcomes and containing public health costs~   "
119628|NCT02001701|"~     Vitreomacular adhesion causes symptoms of blurry vision, distortion, and double vision. It is~     due to an abnormal separation of the vitreous gel from the surface of the retina and macula.~     The current, gold-standard treatment for this condition involves surgery performed in the~     operating room that involves risk such as bleeding, infection, cataract, and retinal~     detachment. It has been previously shown that a less invasive intravitreal injection of a gas~     bubble performed in the office may also treat vitreomacular adhesion with less risk than~     surgery.~      The purpose of this study is to determine the effect of an office-based injection of an~     intravitreal gas bubble as a treatment for symptomatic vitreomacular adhesion.~   "
119605|NCT02002000|"~     Non-systematized chronic musculoskeletal pains are a frequent reason for consulting in~     general practice. The possible causes are numerous and sometimes nonspecific. In some cases,~     the etiologic investigation of patients with non-systematized and chronic musculoskeletal~     pain can not highlight any organic cause. Several studies have shown a link between these~     symptoms and vitamin D deficiency, characterized by a blood level of 25 (OH) vitamin D <~     20.8ng/ml. This deficit is easy to identify and to correct through proper vitamin D~     supplementation with few side effects. Nevertheless, it remains unknown and vitamin D~     deficiency is rarely considered as a possible etiology in patients with chronic pain. We~     hypothesize that vitamin D supplementation in patients with non-systematized musculoskeletal~     pain and deficient in vitamin D could improve painful symptoms. We aim to perform a~     double-blind randomized controlled trial, vitamin D versus placebo, to assess the pain~     improvement after vitamin D supplementation.~   "
119606|NCT02001987|"~     This two part, multi-center, open-label, single-arm study will evaluate the efficacy and~     safety of RoActemra/Actemra as a monotherapy or in combination with non-biologic disease~     modifying antirheumatic drugs (DMARDs) in patients with moderate to severe rheumatoid~     arthritis who have an inadequate response or are intolerant to non-biologic DMARDs or~     biologic therapy. 162 mg RoActemra/Actemra will be administered once a week by subcutaneous~     injection for up to 76 weeks.~   "
119607|NCT02001974|"~     This is a phase I study to evaluate the safety and define the pharmacokinetic (PK) profile of~     orally administered reparixin in combination with paclitaxel in HER 2 (Human epidermal growth~     factor receptor-2) negative metastatic breast cancer patients.~   "
119608|NCT02001961|"~     This will be a cross-sectional, observational study.~      Null hypothesis:~      There is no difference in the amount of extracellular volume (ECV or scarring) in the hearts~     of patients with heart failure as compared to control subjects.~      Heart failure occurs when the heart muscle has become too weak to work properly. It is~     associated with an increase in the amount of connective tissue (collagen) which replaces dead~     heart muscle cells (scarring). Currently a biopsy of the muscle is the only way to measure~     the amount of scarring. This is invasive and rarely done in children. Because of this, it is~     difficult to measure the amount of scarring in a particular patient or disease process, which~     is important for improving our understanding and treatment of the disease.~      Cardiac magnetic resonance imaging (MRI) is a non-invasive imaging tool which is routinely~     used to look at areas of local scarring in heart muscle. Because the scarring is so~     widespread in paediatric patients, we have not been able to use this method previously. Now~     new imaging techniques allow us to look at widespread scarring but these have not yet been~     validated in children.~      We plan to use late gadolinium enhancement (T1 mapping) to measure the amount of scarring in~     patients with heart failure (we have evidence that their heart biopsies show increased~     amounts of scar tissue) and children having MRI scans for other reasons. We will use measures~     of function including echocardiography and 6 minute walk test to compare to the amount of~     scarring. This will help us to know whether the amount of scarring will be clinically useful.~      We will look at the amount of various proteins in the blood of patients and control subjects~     which are related to the scarring and cell death processes. We already use blood tests to~     monitor heart failure and these tests may help us to refine our testing and improve timing of~     treatment (e.g. transplantation).~      This study will help us to design further research in this field.~   "
119609|NCT02001948|"~     The aim of this study was to compare the effects of two different doses of intrathecal~     morphine (0.1 mg and 0.4 mg) combined with 7.5 mg of heavy bupivacaine on postoperative block~     regression times, postoperative analgesia and the severity of side effects, for inguinal~     hernia repairs.~   "
119610|NCT02001935|"~     The aim of this study is to determine whether common CYP1A2 and CYP2E1 gene polymorphisms~     effect metabolism of theophylline in chronic obstructive pulmonary disease patients.~   "
119611|NCT02001922|"~     Background: Chronic obstructive pulmonary disease (COPD) is a progressive respiratory~     disorder characterized by acute exacerbations that contribute to physical impairment and~     increased healthcare use and costs. Given the increasing burden of this disease in terms of~     morbidity, disability, mortality and costs, innovative care models centered on patients and~     aiming at improving quality and comprehensiveness of care are needed. Effective~     implementation and evaluation of chronic disease management - integrated care(CDM-IC)~     programs, in the real world context is of great importance.~      Aim of the pilot study: To conduct a pilot study assessing the acceptability, feasibility and~     effectiveness of a community-based CDM-IC program for COPD patients residing in the canton of~     Valais.~      Design: The evaluation plan of this study will combine both quantitative (controlled~     before-after study design) and qualitative methods (focus groups with COPD patients and~     practicing healthcare professionals).~      Setting: French-speaking part of the canton of Valais.~      Patients: 50 adult (>35 years) COPD patients GOLD stage I (symptomatic) - IV of the disease,~     non-institutionalized and residing in the canton of Valais. The control group of patients~     will be constituted of age and gender-matched COPD patients from the Swiss COPD cohort study.~      Measures:~      Quantitative part:~      Primary outcomes: Generic and disease-specific health-related quality-of-life and all-cause~     hospitalizations (past 12 months)~      Other outcomes:~        1. Processes of care~        2. Patients' assessment of how care is congruent with the Chronic Care Model (PACIC~          instrument)~        3. Measure of self-efficacy (intermediary outcome)~        4. 6-minutes walking test, nb of COPD exacerbations, % of current smokers~        5. Healthcare utilization: unscheduled ambulatory care visits~        6. Care satisfaction~        7. Measures of the process of implementation of the intervention~      Qualitative part: At 12 months: conduct of two focus groups of participating COPD patients,~     and of two focus groups of participating healthcare professionals.~   "
119612|NCT02001909|"~     To investigate the effect of neomycin on the pharmacokinetics (PK) of regorafenib in healthy~     male subjects~   "
119613|NCT02001896|"~     This 2 arm study will compare the efficacy and safety of treatment with erlotinib~     intercalated with platinum-based therapy or erlotinib along, as first line treatment in Stage~     IIIB/IV Non-Small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor (EGFR)~     Mutation. Patients will be randomized to receive gemcitabine (1000mg/m2 iv) on days 1 , and~     cisplatin (75mg/m2) or carboplatin (5xAUC)on day 1, followed by erlotinib 150mg/day from day~     15 to day 28 of each 4 week cycle for a total of 6 cycles,then followed by erlotinib~     monotherapy, or erlotinib 150mg/day .The anticipated time on study treatment is until disease~     progression, and the target sample size is 60 individuals.~   "
119614|NCT02001883|"~     The primary objective of this study is to compare the efficacy and tolerability of low-dose~     statin therapy vs. the association between a low-dose statin and a nutraceutical-based~     protocol in high-dose statin-intolerant patients with coronary artery disease deemed to be at~     high-risk.~   "
119615|NCT02001870|"~     As age increases the chances for a woman to become pregnant decrease as well spontaneously as~     through assisted reproductive technologies (ART). For the treatment of unexplained~     infertilities two techniques can be used: intra-uterine insemination (IUI) and in vitro~     fertilization (IVF). The aim of the present study is to compare the efficiency in term of~     delivery rate of IUI and IVF in couples in whom the female age is over 37 years.~   "
119629|NCT02001688|"~     To evaluate different doses of Kamada-API for Inhalation on the levels of alpha~     1-proteinase inhibitor and other analytes in epithelial lining fluid (ELF) and serum and to~     assess the safety of the treatment in subjects with Alpha-1 Antitrypsin Deficiency.~   "
119981|NCT01997073|"~     Specific Aims: 1) Measure exhalation enthalpy in patients receiving conventional positive~     pressure ventilation during stable hemodynamic conditions. 2) Measure exhalation enthalpy in~     patients following change from two-lung ventilation to one-lung ventilation while minute~     ventilation remains constant.~   "
119616|NCT02001857|"~     Pelvic lymph node dissection (PLND) is the most accurate staging tool to determine lymph node~     involvement in prostate and bladder cancer. The main complication of PLND is development of a~     lymphocele, which can cause symptoms including lower abdominal pain, leg or penile/scrotal~     edema, bladder outlet obstruction, deep venous thrombosis or infection/sepsis. The incidence~     of radiographic (asymptomatic) and symptomatic lymphoceles following PLND varies between~     12,6-63% and 1,6-33% respectively. Medicated sponges such as Tachosil® are indicated in~     surgery for improvement of haemostasis and to promote tissue sealing. They could reduce~     lymphocele development by increased tissue sealing, due to a mechanical effect of the sponge~     itself and a lymphostatic effect of the included thrombin and fibrinogen. Our goal is to~     prospectively assess the lymphostatic effect of Tachosil(r) in patients undergoing~     transperitoneal PLND with or without radical prostatectomy or PLND with bladder cancer~     surgery.~   "
119617|NCT02001844|"~     Modern modular foot-orthoses systems allow an integration of the cost and efficiency benefits~     afforded by the use of pre-formed semi-rigid FOs components, while simultaneously allowing a~     high degree of individualisation of prescription. Such systems, while popular, still remain~     unproven. Recent studies in paediatric rheumatology have made a contribution in developing~     guidelines with regards to pharmacological intervention in arthritic children. In addition,~     specific drug therapy protocols have been published to effectively help general~     practitioners, physiotherapists and ophthalmologists to successfully treat children with JIA~     patients (BSPAR 2006; Hull 2001; NICE guidelines 2002). A Cochrane systematic review on~     treatment of pes planus, highlighted that children with JIA were excluded as a group from~     most of the studies (Ashford et al. 2005). At present little evidence exists for the~     podiatric management of children affected by this disabling pathology, especially for~     orthotic management. This research has provided evidence to support the use of readily~     available off-the-shelf FOs in treating JIA children.~   "
119618|NCT02001831|"~     The aims of the present study are:~      i. To conduct a population study of body composition, muscle function and ability to~     undertake activities of daily living in elderly Irish individuals~      ii. To investigate the effect of a six month period of nutrition supplement support on lean~     tissue mass, and muscle and cognitive function in individuals aged 70 to 80 years.~   "
119619|NCT02001818|"~     The treatment of CML and the expected survival has been revolutionised since the introduction~     of tyrosine kinase inhibitors (TKIs) such as nilotinib. Despite their effectiveness, these~     drugs will never totally remove CML affected cells from the body. In order to achieve this~     goal, and potentially enable CML patients to live without the daily need for TKIs, other~     features of the patient's immune system may need to be harnessed. One possibility is using~     externally administered interferon (IFN) to augment the response induced by the TKI.~      This study will assess the response in terms of length of survival, detection of minimal~     disease levels and time until disease worsens in patients with chronic phase CML who are~     taking nilotinib and pegylated Interferon. Patients will commence taking nilotinib for 3~     months, and once tolerated, will simultaneously be treated with injected pegIFN for up to 2~     years. Patients can continue taking nilotinib beyond this time providing they are receiving~     benefit. Options are available for patients to decrease or increase their dose or to switch~     to another TKI, imatinib, to ensure a balance between drug effectiveness and minimal side~     effects is achieved.~   "
119620|NCT02001805|"~     The investigators wish to compare very active runners in healthy untrained control subjects~     on a number of parameters.~      The project aims to understand the underlying mechanisms by which physical inactivity causes~     diseases. This the investigators will study the full spectrum of physical activity, from the~     most inert of the most active people. The investigators have already collected muscle~     biopsies and established stem cells from people with Type 2 diabetes, obese healthy and~     normal weight healthy. In this study, the investigators will establish a cohort of highly~     physically active marathon runners. In a case-control design, the investigators compare~     muscle stem cell function across the entire spectrum of physical activity / inactivity.~   "
119621|NCT02001792|"~     The purpose of this study is to determine the effects of patient positioning during~     colonoscopy on patient safety and diagnostic outcome.~   "
119622|NCT02001779|"~     Stenting the malignant biliary obstruction is considered to be the preferred palliation~     modality to relieve pruritus,cholangitis,pain and jaundice in patients without surgical~     indications of malignant biliary obstruction.An unicentral clinical trial has demonstrated~     the safety and technical feasibility of an irradiation biliary stent insertion in patients~     with biliary obstruction caused by adenocarcinomas, such a treatment seems have benefits in~     relieving jaundice and extending survival when compared to a conventional biliary~     stent.However,the small sample size,the population distribution of two groups will influence~     the final results in obtaining a powerful statistical conclusion.Therefore,a multicentric~     study was designed to prospectively compared the responses to the treatment with this~     irradiation biliary stent versus the conventional biliary self-expandable stent in patients~     with inoperable malignant biliary obstruction.~   "
119641|NCT02001532|"~     Background~      The prevalence and incidence of type 2 diabetes is increasing globally. A common complication~     of diabetes is the disease of the blood vessels, vascular diseases, which can cause disorders~     like myocardial infarction, stroke and kidney failure. Methods to detect early subclinical~     stages of macro-vascular disease are not yet available in a clinical setting.~      Hypothesis~      Arterial stiffness, an easy accessible vascular parameter, may provide additional prognostic~     information when evaluating risk profile for patients with diabetes type 2.~      Aim~      The aim of the project is to investigate the association between arterial stiffness and the~     occurrence and development of vascular complications in patients with type 2 diabetes.~     Specifically we want to investigate:~        1. in a cross-sectional study, the association between arterial stiffness and subclinical~          atherosclerotic changes in the coronary arteries assessed by computed tomography (CT)~          and~        2. in a longitudinal study, the predictive value of arterial stiffness on the development~          of subclinical cerebrovascular changes assessed by magnetic resonance imaging (MRI) and~          nephropathy assessed by urine analysis.~      Methods~      The study population consists of 100 patients with newly diagnosed type 2 diabetes and 100~     age- and sex matched controls. The study participants were enrolled between 2008-2011 and~     extensively characterized i.a. with arterial stiffness (pulse wave velocity), MRI (white~     matter lesions and cerebral infarctions) and urine analysis (albuminuria). In this study we~     will enrol the same patients in a 5 year follow-up study in order to repeat above mentioned~     measurements. Furthermore, CT is used to investigate the coronary plaque burden of the~     participants (Agatston Score and Segment Involvement Score).~      Results and Perspective~      This project adds new insight into arterial stiffness as a predictor of the progression of~     micro- and macrovascular complications in patients with type 2 diabetes, and can potentially~     improve risk stratification and early strategies of intervention in this patient group.~   "
121274|NCT01980095|"~     The test and treat strategy for treating dyspeptic patients who are H. pylori positive is~     rapidly becoming the standard of care. This study will test the effectiveness of RHB-105, a~     new triple therapy to treat H. pylori infection in dyspeptic patients.~   "
119623|NCT02001766|"~     Type II diabetes (T2D) is characterized by endothelial dysfunction, resulting in a poor~     tissue perfusion and function as well as an increased risk of cardiovascular events. ATP,~     which is released from the red blood cells, contributes to the regulation of the blood flow~     and studies have shown that red blood cells taken from T2D patients have an impaired ability~     to release ATP. However, it is not known whether the changes in the ATP system is an~     underlying cause of the poor tissue perfusion observed in T2D. The purpose of project 1 is to~     test the hypothesis that the deterioration in blood flow in T2D is caused by a reduced~     release ATP from red blood cells, and to test if pharmacological manipulation of cAMP will~     normalize ATP release, plasma ATP levels and thereby blood flow.~      Furthermore, epidemiological studies show a clear link between regular exercise and a reduced~     risk of serious cardiovascular disease. The extent to which a physically active lifestyle may~     improve endothelial function in T2D is unknown. Regular physical activity improves~     vascularization and induces an anti-inflammatory environment. Both the angiogenic and~     anti-inflammatory effects of physical activity is in part mediated by substances released~     from the active muscle. These muscle-derived substances are classified as myokines and have~     paracrine, autocrine and endocrine effects and may thereby affect distant tissues. The~     purpose of the project 2 is to investigate whether high intensity interval training may~     reverse endothelial dysfunction in T2D through increased release of ATP and myokines. In~     individuals with T2D we will determined blood flow in the muscle tissue using advanced~     ultrasound. In addition, using intravascular and intramuscular microdialysis we will~     determine ATP levels in blood and in the muscle interstitium.~   "
119624|NCT02001753|"~     Magnetic resonance (MR) imaging is a widely used and well-established noninvasive medical~     diagnostic imaging tool. By using a static and a gradient magnetic field in combination with~     a radiofrequency field (RF), MR provides excellent contrast among different tissues of the~     body. Although long-term effects on human health from exposure to strong static magnetic~     fields seem unlikely, acute effects such as vertigo, nausea, change in blood pressure,~     reversible arrhythmia, and neurobehavioural effects have been documented from occupational~     exposition to 1.5 T. Cardiac MR (CMR) imaging requires some of the strongest and fastest~     switching electromagnetic gradients available in MR exposing the patients to the highest~     administered energy levels accepted by the controlling authorities. Studies focusing on~     experimental teratogenic or carcinogenic effects of MR revealed conflicting results. Since~     CMR is emerging as one of the fastest growing new fields of broad MR application, it is of~     particular concern that a recent in vitro study with CMR sequences has reported on~     CMR-induced DNA damages in white blood cells up to 24 h after exposure to 1.5 T CMR.~     Therefore, we hypothesized that CMR can induce the damage of endothelium and endothelial~     progenitor cells in type 2 diabetes~   "
119625|NCT02001740|"~     Frozen shoulder or adhesive capsulitis is a common cause of shoulder pain, estimated to~     affect 25% of the general population. Many forms of treatment have been advocated for frozen~     shoulder including physiotherapy, injection with steroid, distension arthrogram with steroid,~     manipulation under anesthetic and arthroscopic releases. There is no general agreement in~     favour of one form of treatment, and the response to a particular treatment varies in~     different series. A few randomized controlled trials appear in the literature. Most of these~     showed improvements with steroid use, but the results were not always statistically~     significant. One randomized control trial reported superior results in favor of arthrographic~     joint distension with steroid compared to a saline placebo. To our knowledge there have been~     no other similar randomized trials to support these results. The objective of this study is~     to determine if arthrographic distension of the shoulder joint with steriods is an effective~     treatment modality for adhesive capsulitis as compared to injection with local anesthetic and~     contrast alone. The study design is a placebo-controlled, double blind clinical trial where~     participants will undergo distension arthrogram of the shoulder and be randomized to receive~     either Triamcinalone (steroid), lidocaine and contrast or injection with lidocaine and~     contrast alone.~   "
119626|NCT02001727|"~     Aims:~        1. Evaluate the long-term effect of screening and eradication of Helicobacter Pylori on the~          prevalence of dyspepsia, and, as secondary outcomes, to assess the effect on dyspepsia~          related health-care consumption and quality of life.~        2. To investigate symptoms of gastroesophageal reflux (GER), dyspepsia and the combination~          of these conditions and the effect on quality of life, prognosis and dyspepsia-related~          health care expenditure.~      Methods:~      In 1998-99 20.000 individuals, age 40-65 years, identified by their civil registration~     number, were allocated by a computerized randomized procedure to HP-screening group and~     control group. All participants received a questionnaire at inclusion, 1-year and 5-year and~     now again at 12 year follow-up assessing the prevalence of dyspepsia and quality of life. In~     addition we will obtain information from registers on, comorbidity, use of endoscopies and~     prescription medication. An economic evaluation is done alongside the randomized trial.~      The primary unscreened group is invited to HP test (13C-urea breath-test) in order to analyze~     the effect of HP-screening according to HP-status~      Expected results:~      The study will provide information on the long-term effect of HP-screening and eradication in~     a population. The study will provide information about the long-term effect on incidence of~     peptic ulcer in an aging population that is likely to have an increased consumption of ASA~     and NSAID. Furthermore the study will generate knowledge about the long-term prognosis of~     dyspepsia and reflux in the population (dyspepsia and reflux. Preliminary results from the~     5-yr follow-up (13) showed that is has a great influence on quality of life and the~     dyspepsia-related health care consumption, whether the individual has solely reflux, solely~     dyspepsia or a combination of both symptoms.~      Long-term follow-up and further analyses of these findings could have great impact on~     management and treatment of individuals with symptoms. It is important to focus on groups; in~     which the symptoms have the greatest influence on quality of life of the individual. This~     finding has not been displayed in other studies.~   "
119627|NCT02001714|"~     This three-site randomized controlled trial compares the effectiveness and cost-effectiveness~     of a group-administered behavioral treatment program to no treatment. Women with stress,~     urgency, or mixed urinary incontinence will be recruited and screened centrally, evaluated~     clinically at each of three study sites, and random assigned to one of two treatment arms: 1.~     Group behavioral treatment or 2. No treatment. Group treatment modalities have the potential~     to reach a larger population of older women with urinary incontinence, not only in the~     traditional medical settings, but also in community settings. The investigators hypothesize~     that group behavioral treatment will be more effective than no treatment. The investigators~     hypothesize that the group treatment will be cost-effective compared to no treatment.~   "
119642|NCT02001519|"~     Achievement of pathologic complete response is important prognosticator to predict long term~     outcome in triple negative cancer. The efficacy of adding 4 cycles of cisplatin (CDDP4) is to~     be investigated whether addtional pathologic complete response is achieved for those triple~     negative breast cancer patients who recieved 4 cycles of adriamycin with~     cyclophosphamide(AC4) but did not reach clinical complete response during the course of~     neoadjuvant therapy.~   "
121275|NCT01980082|"~     We hypothesized that revision clean head & neck surgery may have a higher rate of wound~     infection that may be lowered with prophylactic antibiotic treatment.~   "
119630|NCT02001675|"~     Neuromuscular electrical stimulation (NMES) has emerged as a suitable tool for restoring,~     maintaining and/or enhancing muscular performance. From a practical point of view, NMES can~     elicit contractions either by direct activation of motor axons (i.e. peripheral mechanism) or~     by the recruitment of motoneurons in the spinal cord through the depolarization of sensory~     axons (central mechanism). It is noteworthy that NMES parameters widely affect the balance~     between transmission along these two pathways. Conventional NMES is usually delivered using~     short pulse duration (0.05-0.4 ms), low stimulation frequency (15-40 Hz) and high stimulus~     intensities so that the large antidromic volley in motor axons ensures that the evoked~     contraction will be driven largely by the direct depolarization of motor axons beneath the~     stimulation site with no or little involvement of central nervous system. On the contrary,~     when NMES is delivered using wide pulse widths (1 ms) and high frequency (up to 100 Hz)~     (WP-HF NMES), a portion of the evoked contraction arises from a central mechanism and the~     corresponding force (recently referred to as extra force) is significantly (three times)~     larger than the conventional NMES-induced force. This extra force is supposed to represent~     the central contribution from the recruitment of spinal motoneurons by the evoked afferent~     volley given that no additional force was observed during a complete anesthetic block of the~     nerve proximal to the stimulation site. Despite the obvious differences in terms of~     activation of the neuromuscular system between conventional and WP-HF NMES, the functional,~     metabolic and cortical responses associated to both protocols remain to be determined~   "
119631|NCT02001662|"~     The investigators want to explore the analgesic effect of Adductor Canal Blockade (a~     peripheral nerve block) in high pain responding patients after arthroscopic knee surgery. The~     investigators hypothesize that the nerve block will have an abrupt analgesic effect.~   "
119632|NCT02001649|"~     Suicidal behaviors is known to aggregate in families. The purpose of this study is to~     evaluate association between common polymorphisms in genes important for neurobiological~     pathways linked to suicidal behaviors and suicide attempt among adolescents patient.~   "
119633|NCT02001636|"~     Obese patients, who underwent bariatric surgery, are at risk to develop protein malnutrition.~     The aim of this study is to evaluate the influence of postoperative protein supplementation~     on weight reduction, body composition and protein status.~   "
119634|NCT02001623|"~     The purpose of the trial is to establish the tolerability of HuMax-TF-ADC in a mixed~     population of patients with specified solid tumors.~   "
119635|NCT02001610|"~     Commercial probiotics can be delivered in numerous forms. The two most common delivery forms~     are similar to the two product formats to be tested. It has been demonstrated using in vitro~     testing that probiotic organisms that are unprotected from gastric exposure may not survive~     that exposure and therefore may not remain viable throughout the rest of the GIT.~     (Unpublished studies conducted at SNA research facility, February, 2010.) Similar in vitro~     testing of Acidophilus Pearls has demonstrated the probiotic organisms in an enteric capsule~     will survive gastric exposure. It is anticipated that this difference in in vitro gastric~     survivability will translate to improved digestive tract survivability that can be~     demonstrated using fecal recovery techniques.~      The commercial product to be tested in this clinical trial has been in the market for over 17~     years. However, it is not known what effect this commercial product has on the commensal~     probiotic population in the gut and particularly in the lower bowel where much of probiotic~     benefits are believed to be largely realized. Also, it is not known what effect the~     commercial product has on the total commensal microbiota or fecal pH. While commercial~     probiotic products have been largely aimed at benefits related to improved health, they also~     have the potential to change overall gut microbiota (probiotics as well as all others)~     composition and activities. Learning what happens to the overall gut microbiota can be a~     helpful step in establishing the potential health benefits of the probiotic class of~     organisms in the test products.~   "
119636|NCT02001597|"~     Radical prostatectomy, or the surgical extirpation of the prostate, is a standard treatment~     for prostate cancer. The state of the art radical prostatectomy involves a robotic~     laparoscopic surgery system (the da Vinci) which provides the surgeon with excellent 3D~     visualization of the surgical site and improved dexterity over standard laparoscopic~     instruments. While the long term prognosis of prostate cancer patients who undergo radical~     prostatectomy has improved significantly over the past two decades, there remain significant~     rates of disease recurrence and complications.~      The investigators hypothesis is that advanced trans-rectal ultrasound (TRUS) imaging can be~     deployed and used easily during surgery, can be registered to the robot coordinate systems~     with high accuracy, and can be controlled from the surgeon's console, in order to improve the~     visualization of the prostate and peri-prostatic anatomy, and in order to produce a cancer~     probability map that can be used to make decisions on surgical margins.~      The investigators objectives are~        1. To demonstrate that TRUS imaging can be integrated with the da Vinci radical~          prostatectomy~        2. To determine the ability of TRUS imaging to intra-operatively visualize the prostate and~          peri-prostatic tissue from the surgical console~      This is an observational study; trans-rectal ultrasound will be used to visualize the~     prostate and periprostatic structures during surgery but the standard of care will not be~     affected by this ultrasound imaging.~   "
119637|NCT02001584|"~     The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of~     a predefined dose range of co-administered Baclofen and Memantine in non-obese (Part A) and~     obese (Part B), otherwise healthy subjects.~   "
119638|NCT02001571|"~     The purpose of this study is to evaluate the safety and pharmacokinetics (study of what the~     body does to a drug) of 1000 mg oral dose of abiraterone acetate and its major metabolite(s)~     with mild or moderate hepatic impairment and matched control Participants with normal hepatic~     function.~   "
119639|NCT02001558|"~     The purpose of this study is to test how well Microcyn™ works on Stage 3 and Stage 4 pressure~     ulcers compared to sterile saline among persons with spinal cord injury.~   "
119640|NCT02001545|"~     RE-ACT is a national, multi-centre, observational, prospective, longitudinal cohort study~     which will include patients hospitalized for ACS within 24 hours of symptom onset and who~     have a final diagnosis of ST-segment elevation myocardial infarction (STEMI) or~     non-ST-segment elevation myocardial infarction (NSTEMI). This study aims to describe the~     short-term (at the end of the first month after index event) antithrombotic management~     patterns in a real-life setting for patients hospitalized with an acute coronary syndrome.~   "
119644|NCT02001493|"~     Antiangiogenics are the mainstay of treatment in patients with metastatic renal cell~     carcinoma. Conventional clinical end-points, used to measure efficacy with chemotherapeutic~     agents, have not been helpful in monitoring the efficacy of antiangiogenic therapy.~     Increasing numbers of predictive and pharmacodynamic biomarkers are being investigated that~     are useful surrogates for clinical response and also to identify patients early on who will~     benefit from this class of agents. This is valuable in avoiding unnecessary toxicity in~     patients and also in reducing cost implications of this expensive group of drugs.~      The investigators wish to explore the variability of baseline metabolomic profile in the~     blood and urine of patients with mRCC and characterise the inter-subject and intra-subject~     variability. The study of the baseline levels has not been performed in this cohort~     previously. This is extremely important in interpreting the emerging data of changes in the~     levels of the various biomarkers from various trials. This will in turn help in the~     development of future targeted therapies, especially Phase I/II studies where an early~     demonstration of target modulation is vital. This study will also help to identify the number~     of patients required for appropriate statistical evaluation in pharmacodynamic studies to~     assess biological activity, optimisation of dosing, and investigation of potential mechanisms~     of resistance. Study of the urinary and blood metabolomic profile in conjunction will give us~     an insight into the potential use of urine as a diagnostic and prognostic tool.~      OBJECTIVES GOAL The main objective of the study is to determine the change from baseline in~     metabolomic profiling in patients with clear cell renal cell carcinoma 1 month after~     nephrectomy or antiangiogenic treatment during 2 months~   "
119645|NCT02001480|"~     Aim: Patients with type 2 diabetes mellitus (T2DM) and hemodialysis due to diabetic~     nephropathy exhibit a high risk for sudden cardiac death (SCD). Preliminary data suggest that~     beta-blocker treatment may reduce arrhythmias and mortality in this high-risk population.~     However, no results from large-scale clinical outcome trials with beta-blockers exist in this~     patient group and a broad, scientifically unapproved use of beta-blocker treatment may not be~     justified due to potential harmful side-effects such as AV-block or hypotension. In addition,~     we are lacking identified ECG surrogate parameters for SCD in this high-risk population and~     on the occurrence of arrhythmias in temporary relationship to hemodialysis sessions.~      Therefore, the present study will identify surrogate parameters of SCD in hemodialysis~     patients with T2DM and in an interventional trial investigate the suppressive effect of~     beta-blockers on these identified ECG markers.~   "
119646|NCT02001467|"~     Simulation-based training lead to improvements in learning compared to no intervention but~     little is known of the effects on organizational improvements that are relevant to patient~     care. This study focused on the effects of training midwives in performing cervical~     ultrasound scans on continuity of care when managing pregnant women with symptoms of~     premature onset of labor. Our hypothesis is that simulation-based training can be used to~     decrease the number of shifts in primary responsible health care practitioner as midwives~     that are trained in cervical ultrasound scans may manage the patient encounter without~     engaging a second practitioner (i.e. an obstetrician).~   "
119647|NCT02001454|"~     The purpose of this study is to compare attitudes and knowledge of the staff of various~     departments in our Medical Center in regards to pain treatment. With the results of our~     survey we will then draw up a protocol on pain management.~   "
119648|NCT02001441|"~     This project will examine the relationship between physical activity levels, brain structure~     and memory function in adults with Mild Cognitive Impairment (MCI) aged 60 to 75. The study~     will follow 30 adults with age-associated memory impairment or MCI over the course of 18~     months. During this time, subjects' physical activity levels will be measured regularly and~     related to both the thickness their hippocampus and to their memory performance. Subjects~     will be recruited and screened for major health problems at UCLA. Physical activity will be~     tracked for two weeks using accelerometers at baseline and every 6 months during the study.~     At baseline and at the end of the study, subjects will undergo a structural MRI brain scan to~     measure hippocampal thickness, as well as a neuropsychological evaluation to measure memory~     function. The study will seek to determine the relationship between physical activity level,~     hippocampal thickness and memory performance in older adults with age-associated memory~     impairment.~   "
119649|NCT02001428|"~     The purpose of this study is to assess the effectiveness of different malaria control~     strategies in the first year of life.~      The effectiveness of delivering an intermittent screening and treatment programme with~     dihydroartemisinin-piperaquine (DHP), linked to local immunization programmes, will be~     compared to the current practice of passive case detection of malaria.~      This study has two objectives:~        1. To assess the effectiveness of intermittent screening and treatment with~          dihydroartemisinin-piperaquine (DHP) administered at 2, 3, 4 and 9 months of age~          compared with the current practice of passive detection and treatment for malaria in an~          area with high drug resistance levels to both P. falciparum and P. vivax.~        2. To evaluate the safety, efficacy and population pharmacokinetics of DHP in children~          under 1 year of age.~   "
119650|NCT02001415|"~     The purpose of this study is to determine the efficacy of different lens treatments (normal~     spectacle lens, ortho-K, & Myovision) on myopia control in Chinese adolescent patients.~   "
119651|NCT02001402|"~     A follow-up intervention for the climacteric symptoms of nurses in Peking~   "
119652|NCT02001389|"~     This is an open-label, single-arm, multiple ascending dose Phase I study to assess the dose-~     and concentration-dependent displacement of [18F]MNI-659 [a PET tracer targeting~     phosphodiesterase 10 (PDE10)] by EVP-6308.~   "
119666|NCT02001207|"~     In critical illness, patients are highly stressed and should have elevated cortisol (stress~     hormone) secretion to adapt to stress. Dysfunction of this system is referred to as critical~     illness-related corticosteroid insufficiency. Free cortisol (unbound form) which is mainly~     responsible for its physiologic function is difficult to measure. We hypothesized that the~     salivary cortisol, which can be obtained by noninvasive methods, can more accurately evaluate~     adrenal function of critically ill patients.~   "
119793|NCT01999556|"~     The purpose of this study is to obtain high quality specimens for molecular studies for the~     identification and characterization of genetic mutations involved in the pathogenesis of~     familial myeloid malignancies. Specimens obtained will be de-identified, linked to basic~     clinical data, and sent to Washington University (Division of Oncology, St. Louis, MO) for~     molecular analyses. Some specimens sent to Washington University may also be used for quality~     control analyses.~   "
119653|NCT02001376|"~     Background and Purpose: Fitness is the foundation for health and quality of life for~     individuals. Recent changes in lifestyle and eating habit in Taiwan have significantly~     increased the prevalence of metabolic syndrome that may lead to poor fitness and subsequent~     coronary artery disease, cardiovascular disease and diabetes. Although workers at the~     National Taiwan University Hospital (NTUH) have undertaken regular health fitness~     examination, the examination did not include the posture and movement analysis and no~     exercise intervention was provided to those with metabolic syndrome. This study is therefore~     aimed to conduct comprehensive health fitness examination for workers at NTUH and to examine~     whether exercise intervention could decrease the risk factors and enhance fitness in those at~     risk or with metabolic syndrome. Methods: This study will consist of two parts. In the first~     part, 1102 workers at NTUH will be administered comprehensive fitness examination (body mass~     index, waist circumference, muscle strength, flexibility, balance, cardiopulmonary test, and~     posture and movement analysis) and will be assessed with the Physical Activity Readiness and~     the Perceived Musculoskeletal Pain Scale and the International Physical Activity~     Questionnaire. Those workers who are at risk or have metabolic syndrome (N=240) will be~     assigned into the control, home-based exercise, and intensive exercise group with 80 in each~     group with their will. The home-based exercise group will receive exercise instruction~     biweekly for three months; the intensive exercise group will receive moderate aerobic~     exercise and strengthening exercise three times a week for three months. The other workers~     who are insufficient fitness status (N=240) will be assigned into the control, home-based~     exercise, and intensive exercise group with their will. The home-based exercise group will~     receive exercise instruction biweekly for a month; the intensive exercise group with 80 in~     each group will receive moderate aerobic exercise and strengthening exercise three times a~     week for a month. Descriptive statistics will be used to estimate the prevalence of 1, 2 and~     ≧3 metabolic risk factors, and poor fitness. One-way analysis of variance (ANOVA) will be~     used to examine the relation between metabolic syndrome risk factors and fitness. One-way~     ANOVA will be used to compare the demographic characteristics of the control, home-based~     exercise, and intensive exercise group. Two-way ANOVA repeated measures will be used to~     examine the metabolic syndrome risk factors and fitness in the three groups across time.~     Clinical relevance: Our results will help understand the health fitness of workers at NTUH~     and will assist in establishing effective exercise program for those at risk or with~     metabolic syndrome.~   "
119654|NCT02001363|"~     The investigators planned to research the cardioprotective effects of intravenous liraglutide~     on reperfusion injury.~   "
119655|NCT02001350|"~     To use carotid ultrasound to screen 20-30 patients with longstanding or resistant~     hypertension for carotid atherosclerotic disease and bifurcation anatomy. This will establish~     a screening protocol for Cibiem's eventual endovascular carotid body modulation trial and~     will give insight into the prevalence and specific location of carotid plaque at the~     bifurcation in this patient population.~   "
119656|NCT02001337|"~     The purpose of this study is to create a prospective cohort of subjects with increased~     probability of being diagnosed with pancreatic cancer and then screen this cohort for~     pancreatic cancer~   "
119657|NCT02001324|"~     This is an observational study to determine the effect of various treatments prescribed by~     healthcare providers for heavy menstrual bleeding on bleeding related quality of life (as~     measured by the Menstrual Bleeding Questionnaire) and to compare electronic and paper-based~     modes of data collection.~   "
119658|NCT02001311|"~     This study investigates the benefit of using chlorhexidine gel as an antimicrobial agent in~     orthodontic patient to reduce caries risk and the possible consequential effect of this use~     on the orthodontic brackets used for the treatment.~      The investigators hypothesis is that chlorhexidine gel use can reduce caries risk in~     orthodontic patients with out causing damage to the bonded ceramic or metal orthodontic~     brackets.~   "
119659|NCT02001298|"~     The purpose of this study is the comparison of the cardiovascular effects of remifentanil and~     nitroprusside for controlled hypotension~   "
119660|NCT02001285|"~     The purpose of this study is the comparison of the effect-site concentration of remifentanil~     for blunting hemodynamic responses to ordinary tracheal and double-lumen endobronchial~     intubation during propofol-remifentanil total intravenous anesthesia.~   "
119661|NCT02001272|"~     The current standard of first-line chemotherapy in advanced ovarian cancer is the combination~     of carboplatin AUC 5mg/mL/min and paclitaxel 175 mg.m-². This combination is feasible in~     selected elderly patients such as those included in prospective trials. These trials,~     however, include a minority of the elderly population. In wider selection of patients >70~     years old, the standard carboplatin-paclitaxel regimen has been shown to induce an excess of~     toxicity and premature treatment stopping. For elderly patients thought to be vulnerable and~     at high risk of toxicity with the standard 3-weekly carboplatin-paclitaxel regimen, other~     options are used in routine practice. One option is to delete paclitaxel and treat elderly~     patients with carboplatin as a single agent. An alternative is to use the~     carboplatin-paclitaxel regimen in a weekly schedule for both drugs such as reported by the~     MITO (Multicentre Italian Trial in Ovarian Cancer).~      To date, there is no randomized trial which could give us some evidence of how to select~     patients who could benefit most of one or the other regimen described above. The 4th Ovarian~     Cancer Consensus Conference has indeed recognised the medical unmet need of adapted therapy~     for elderly patients with ovarian cancer and the necessity of additional research in this~     population.~      Recently, GINECO has described a Geriatric Vulnerability Score (GVS) in a population of~     elderly patients with advanced ovarian cancer included in a specific multicenter phase II~     trial. The best proportional hazard model fitting for overall survival identified the~     following geriatric covariates score as being poor survival risk factors: ADL score <6, IADL~     score <25, HADS score >14, albuminemia <35g/L and , lymphopenia <1G/L. GVS is the sum of~     these risk factors for each patient. Using a cut off of 3, the GVS identified a group of~     patients at high risk of severe toxicity, early cessation of treatment, unplanned~     hospitalization and adverse outcomes.~      This international multicentre randomized phase II trial will compare the success rate of~     delivering 6 courses of chemotherapy with evidence of efficacy and without premature~     termination for progression, death or unacceptable toxicity of three different chemotherapy~     regimens in a selected population of elderly patients with a GVS ≥ 3:~        -  Arm A: Paclitaxel 175mg/m²/3 hours, I.V. and carboplatin AUC 5, I.V. every 3 weeks~        -  Arm B: Carboplatin monotherapy AUC 5 or 6 every 3 weeks~        -  Arm C: Weekly paclitaxel 60 mg/m²/1 hour and weekly carboplatin AUC 2 (d1, d8, d15 every~          4 weeks)~      The total number of patients to be enrolled is 240, ie 22 in each arm (total = 66) at the~     first step, then 58 more by arm (total=174) after interim analysis.~   "
119662|NCT02001259|"~     The purpose of this study is to determine efficacy of epidural steroid for postoperative pain~     control after TKA~   "
119663|NCT02001246|"~     The general aim of the proposed pilot study is to evaluate the the efficacy of mind-body~     bridging (MBB) for anger management compared with the Real Deal anger management program, in~     helping adolescents control or reduce their anger.~   "
119664|NCT02001233|"~     The purpose of this follow-up study is to evaluate the two-year efficacy, immunogenicity and~     safety of EV71 Vaccines in preventing Hand, Foot and Mouth disease caused by EV71 in a total~     10,000 healthy infants volunteers aged from 6 to 35months old.~   "
119665|NCT02001220|"~     During weaning the work of breathing is transferred from the ventilator back to the patient.~     Approximately 40% of the time on ventilators is spent weaning. Studies support the use of~     screening protocols and tests of patient's ability to breathe spontaneously (SBTs) to~     identify weaning candidates. Once daily screening is the current standard of care. With~     respiratory therapists (RTs) in Canadian intensive care units (ICUs), a significant~     opportunity exists to screen patients more frequently, conduct more SBTs, and reduce the time~     spent on ventilators and in the ICU.~      The study is seeking to identify the optimal screening frequency to minimize patients'~     exposure to invasive ventilation. The RELEASE Trial will evaluate a simple a simple~     construct: more frequent screening will result In earlier identification of weaning~     candidates, more frequent SBT's, and less time spent on ventilators and in the ICU. More~     frequent screening is an appealing intervention because it is sensible, low risk, and~     represents a cost effective use of current resources. This simple intervention holds promise~     as a strategy that could change clinical practice, enhance the care delivered to critically~     ill adults, and improve clinically important outcomes.~   "
119667|NCT02001194|"~     Employers are increasingly looking for opportunities to motivate sedentary employees to~     become more physically active. Workplace walking programs have had mixed success and~     typically show most improvement among participants that are already fairly active at a~     baseline. The goal of this study is to determine whether a financial incentive program can~     motivate sedentary employees to increase the number of steps they walk per day to meet a~     minimum threshold.~      Our primary outcome measure is the proportion of days a minimum activity of 7000 steps or~     more is achieved. We will assess outcomes each week for 3 months using incentives followed by~     3 months of follow-up without incentives. Secondary outcomes will include the average steps~     walked per day.~   "
119668|NCT02001181|"~     The study is being conducted to evaluate the efficacy, safety and tolerability of 2%~     tofacitinib ointment (20 mg/g) BID (twice daily) in subjects with mild to moderate atopic~     dermatitis compared to placebo (vehicle) BID for 4 weeks.~   "
119669|NCT02001168|"~     -  Lung cancer is one of causes of the malignant tumor-associated death on a global scale,~          in which the surgery is the only effective approach in patients with non-small cell lung~          cancer (NSCLC). As present, the total postoperative 5-year survival rate of NSCLC is~          40%, while only 4%～15% patients can benefit from adjuvant chemotherapy[1]. American~          National Comprehensive Cancer Network (NCCN) manual recommends that adjuvant~          chemotherapy can be performed on NSCLC patients in phase Ⅱ～ⅢA.~        -  In order to assure the necessity of adjuvant chemotherapy on NSCLC patients in phase ⅠB~          or which kind of patients would benefit from it after the establishment of new staging,~          a multi-subject group of lung cancer set up a perspective, randomized, open clinical~          trial to explore whether adjuvant chemotherapy was effective on NSCLC patients in phase~          ⅠB under new staging policy, and to collect the characteristics of patients who could~          benefit from the treatment and the better adjuvant drugs after operation.~   "
119670|NCT02001155|"~     A test that was common in the 1960's and was used to detect primary open angle glaucoma was~     the water drinking test (patients drank 1 quart of water to stress the fluid drainage~     mechanism of the eyes. Intraocular pressure was then measured over the next hour). Recently~     this test has been demonstrated as a predictor of peak eye pressure during the day. The~     purpose of this study is to compare the results of the water drinking test between eyes that~     have undergone trabeculectomy and eyes that have undergone tube shunt surgery.~   "
119671|NCT02001142|"~     One of the main objectives of this study will be to assess potential differences in important~     risk factors associated with Metabolic Syndrome in overweight adults who do not participate~     in a regular exercise program compared with overweight individuals who do exercise regularly.~     In addition, we will determine the effects of a single, modest session of exercise on the~     body's ability to control blood sugar and regulate fat metabolism in obese sedentary adults~     vs. obese adults who live a physically active lifestyle. Our study focuses on identifying~     mechanisms responsible for improved insulin action related to regular exercise and to provide~     novel targets for preventing and treating type 2 diabetes.~   "
119672|NCT02001129|"~     This study aims to examine the effectiveness of three different ways of helping patients~     attend their recommended eye care appointments.~   "
119673|NCT02001116|"~     A cooperation agreement between the Ministry of Health (MOH) of Kyrgyz Republic and WHO-EURO~     was established, for the implementation of a WHO Project to improve the quality of pediatric~     care in the referral hospitals. The pilot regions selected for this intervention are the~     three northern regions of Thalas, Chiu and Issik-Kul Region in Kyrgyz Republic. The MOH~     project will be implemented at a first stage in a group of 10 pilot hospitals, randomly~     selected among the existing hospitals in the above cited regions. Pilot Hospitals will be~     compared to control hospitals, which are the hospitals in the region not receiving the~     intervention, using a pre-defined set of indicators of quality of care. The results of the~     present evaluation on the pilot hospitals will provide data that will inform the MOH on how~     better to scale up this project at a national scale.~   "
119674|NCT02001103|"~     The specific aim of this project is to test if memantine add-on therapy will be helpful for~     patients with first episode schizophrenia who present with or without cognitive impairments~     and negative symptoms, to examine the efficacy and safety of memantine as an adjuvant agent~     to their ongoing maintenance therapy with atypical antipsychotics. Our objectives include:~        1. Test memantine add-on by 2 different dosages comparing to a placebo-controlled group of~          clinically stable first episode schizophrenic patients who are under second-generation~          antipsychotic maintenance therapy. The results will give us information regarding~          effective dosage and the profile of adverse drug reactions while using on this~          population.~        2. Examine whether the effect of memantine add-on will be affected by any significant~          baseline clinical variables or predisposed cognitive deficits. That is to say, if~          memantine will only demonstrate adjunctive effect on those who are cognitively impaired~          or its effect is independent from baseline cognitive functioning or the severity of~          baseline psychopathology.~        3. Examine the changes in negative symptoms as the secondary outcomes to see if such a~          cognitive enhancing effect to be concurrent with an improvement in negative symptoms or~          independent from changes in negative symptoms.~        4. Treat the changes in positive symptoms and other clinical outcomes, such as readmission,~          being employed/going back to school, and psycho-social functioning scores as the~          tertiary outcomes to examine the effectiveness of memantine add-on.~   "
119675|NCT02001090|"~     This study examines the flow mediated dilation (FMD) of the brachial artery before and after~     cardiac surgery. FMD is measured with ultrasound technique. Increased flow is achieved trough~     obstructing blood flow with a cuff around the forearm for five minutes. FMD is measured~     before surgery and on the first morning after the operation.~   "
119676|NCT02001077|"~     This is a single-center, randomized controlled trial study design. Enrolled participants had~     comorbid fibromyalgia and chronic insomnia. Participants were randomized to a behavioral~     intervention for pain, a behavioral intervention for insomnia, or a waitlist control. The~     study intervention period lasted eight weeks. The objective of the study is to examine the~     impact of two behavioral treatments on sleep and pain and to better understand what causes~     chronic pain and chronic sleep disturbance.~   "
119684|NCT02000973|"~     The investigators designed a prospective, randomized, placebo-controlled study to determine~     whether thoracic epidural anesthesia(TEA) with different local anesthetics has different~     influences on the propofol dose during induction.~   "
119677|NCT02001064|"~     Although poor antiretroviral (ART) adherence in HIV does not mean a complete lack of~     therapeutic results, the benefit of ART increases as adherence improves. Consequences of~     suboptimal ART adherence are viral rebound, development of drug-resistant HIV strains, and~     more rapid progression to AIDS. Moreover, HIV-infected persons tend to have numerous~     co-occurring conditions and therefore take many medications making adherence to multiple drug~     regimens more difficult. A mobile application capable of improving medication adherence among~     HIV-infected persons would be highly useful.~      The investigators propose an intervention study designed to address these potential~     mechanisms of nonadherence by utilizing the Care4Today v2.0 smartphone application (app). The~     current study is a small pilot Randomized Controlled Trial (RCT) comparing the smart phone~     application titled Care4Today v2.0 versus standard of care to improve medication adherence~     to ART over a 4-week period with 60 HIV+ participants.~      The pilot RCT consists of 60 HIV+ persons who are at risk for ART medication nonadherence.~     Using random assignment, 30 HIV+ participants will be assigned to medication adherence~     improvement via Care4Today app as compared to 30 HIV+ participants assigned standard of~     care.~      The investigators will assess the effectiveness and acceptability of the app in improving~     objectively measured ART adherence (i.e., via medication event monitoring system caps) over a~     4-week period via a pilot RCT with 30 HIV+ persons assigned to the Care4Today intervention~     and 30 HIV+ persons assigned to standard of care.~   "
119678|NCT02001051|"~     Background:~      - Adrenal tumors are a common kind of tumor. Some of these secrete extra cortisol into the~     body, which can lead to diabetes, obesity, and other diseases. Some people with extra~     cortisol will show symptoms like bruising and muscle weakness. Others will show no signs.~     This is called subclinical hypercortisolism. Some of these adrenal tumors become malignant.~     Researchers want to know the best way to treat people with subclinical hypercortisolism. They~     want to know if removing the tumor by surgery reduces the long-term effects of the disease.~      Objectives:~      - To see if removing an adrenal tumor by surgery improves blood pressure, diabetes, obesity,~     osteoporosis, or cholesterol, and cancer detection.~      Eligibility:~      - Adults 18 and older with an adrenal tumor and high cortisol levels.~      Design:~        -  Participants will be screened with medical history, blood tests, and a computed~          tomography (CT) scan.~        -  Participants will have a baseline visit. They will have blood and urine tests and 7~          scans. For most scans, a substance is injected through a tube in the arm. Participants~          will lie still on a table in a machine that takes images.~        -  Participants will have surgery to remove their tumor. Some will have surgery right away.~          Some will have surgery 6 months later, after 2 follow-up appointments.~        -  Participants will have 4 follow-up visits in the first year after surgery. They will~          have 2 visits the second year, then yearly visits for 3 years. At each follow-up visit,~          they will have scans and blood tests.~   "
119679|NCT02001038|"~     Charcot-Marie-Tooth (CMT) disease is the most common inherited peripheral neuropathy. Foot~     deformities are frequent complications in CMT patients and orthopaedic surgery is often~     required. As yet there are no systematic studies on the management of orthopaedic~     complications in CMT patients and the current approach varies between centres. This study is~     a survey with the aim of understanding the current surgical approach to orthopaedic~     complications in CMT.~      The target population includes orthopaedic surgeons who perform surgical procedures for foot~     deformities in CMT patients attending centres participating in the Inherited Neuropathies~     Consortium (INC).~   "
119680|NCT02001025|"~     The biodegradable ABSORB scaffold is characterized by a greater strut thickness, but it has a~     greater flexibility compared to the XIENCE stent. Due to its fragility the inflating pressure~     of the ABSORB scaffold is limited and suitable lesions have to be well prepared. This study~     assesses the incidence of malapposed stent-struts, and the frequency of stent-underexpansion~     and edge dissection after ABSORB implantation compared to the XIENCE stent.~   "
119681|NCT02001012|"~     Preliminary studies have supported the background efficacy of local standard anti-malarial~     medications in the treatment of uncomplicated knowlesi malaria, however there are no current~     WHO treatment guidelines for this infection. There are both health cost benefits to a more~     rapidly acting agent, and due to difficulties with microscopic identification there may be~     more effective treatment for all malaria species if an aligned treatment guideline could be~     supported. We are currently conducting a separate RCT using a similar protocol evaluating~     artesunate-mefloquine versus chloroquine for uncomplicated P. knowlesi malaria. However~     artemether-lumefantrine should also be compared against chloroquine due to the fact it is~     also a first line anti-malarial recommended in Malaysia, and there are potential differences~     in efficacy due to the different administration, absorption and half-life of~     artemether-lumefantrine.~      The investigators aim to test whether the fixed combination of artesunate-mefloquine is~     superior to chloroquine in order to define the optimal treatment for both uncomplicated P.~     knowlesi infection in both adults and children in this region.~   "
119682|NCT02000999|"~     The purpose of this prospective study is to compare the diagnostic utility of two techniques~     (brush cytology + FISH and brush cytology + free DNA analysis) in the diagnosis of biliary~     strictures. Histologic diagnosis (biopsies) in conjunction with clinical and/or imaging~     follow-up will serve as the gold standard for diagnosis of malignancy. In order to do this~     the investigators will ask study participants to have a small volume of fluid obtained from~     the bile duct sent for additional testing at RedPATH. In some patients additional brushings~     will be obtained for FISH testing (this adds <2 minutes to ERCP and only associated risk is~     increased procedure duration).~      The investigators hypothesize that the use of cytology +DNA analysis has a higher sensitivity~     and accuracy when compared to cytology +FISH in patients with biliary strictures.~      Primary aim:~      To compare the sensitivity and accuracy of the two techniques (brush cytology + FISH and~     brush cytology + free DNA analysis). Histologic diagnosis (histology from biopsy or cytology~     for fine needle aspiration) in conjunction with clinical and/or imaging follow-up will serve~     as the gold standard for diagnosis of malignancy.~      Secondary aims:~        1. To evaluate the diagnostic yield of malignancy when all three techniques (cytology, FISH~          and DNA analysis) are used.~        2. To evaluate the added value of biliary forceps biopsies, when used in conjunction with~          cytology, FISH and DNA analysis.~   "
119683|NCT02000986|"~     This clinical trial studies dietary and exercise interventions in preventing cardiovascular~     disease in younger survivors of childhood cancer. Eating a healthy diet and exercising~     regularly may reduce the risk of cardiovascular disease in younger survivors of childhood~     cancer.~   "
119685|NCT02000960|"~     Glucose transporter deficiency syndrome (Glut1-DS) is a form of pediatric epilepsy caused by~     a genetic mutation that disrupts the body's ability to process food from the child's diet~     into sugar (energy) needed to support brain function. Children with Glut1-DS experience~     seizures that are not controlled by anticonvulsant medications, as well as delays in~     cognitive and motor development. Currently, Glut1-DS is treated with the ketogenic diet, a~     high-fat, low-sugar diet that provides the brain with an alternate source of energy. Despite~     the significant improvement of seizures upon this diet, seizure control is incomplete in a~     majority of children, and they continue to experience problems with brain development. Our~     team of researchers and clinicians with expertise in metabolic diseases, neurology,~     pediatrics, biochemistry, and genetics believes that there is an opportunity to achieve~     CURE's goal of No Seizures/No Side Effects for children with Glut1-DS by investigating the~     use of a new treatment option that is designed to compensate for the underlying biochemical~     deficiency thought to contribute both to the seizures and to the impaired brain development~     associated with Glut1-DS. The proposed treatment involves incorporating a special type of~     oil, called triheptanoin, into the ketogenic diet as a way to make up for a specific~     biochemical deficit affecting kids with Glut1-DS that the standard ketogenic diet fails to~     address. Our goal is to do a pilot study to test the safety and effectiveness of this~     promising new treatment option in a small group of children with Glut1-DS.~   "
119686|NCT02000947|"~     The purpose of this study is to determine if MEDI4736 will be adequately tolerated in~     combination with tremelimumab in subjects with advanced non-small cell lung cancer (NSCLC).~   "
119687|NCT02000934|"~     This study is an open-label, multicenter, phase 1, dose escalation study of TAK-659 in adult~     participants with advanced solid tumor and lymphoma malignancies. This study will be the~     first to administer TAK-659 to humans. The participants population during dose escalation~     (Part A) will consist of adults previously diagnosed with any form of a solid tumor or~     lymphoma for which standard, curative, or life-prolonging treatment does not exist or is no~     longer effective. This first-in-human (FIH) study will include 5 dose expansion cohorts in~     refractory and/or relapsed Chronic Lymphocytic Leukemia (CLL), Diffuse Large B Cell Lymphoma~     (DLBCL), indolent Non Hodgkin Lymphoma (iNHL), Mantle Cell Lymphoma (MCL), Post Transplant~     Lymphoproliferative Disorder (PTLD) (Part B) following completion of dose escalation (Part~     A).~   "
119688|NCT02000921|"~     The main focus of this study is to determine the use of nicotine-containing products across~     the three experimental conditions. Subjects will be monitored to determine their continued~     use of assigned cigarettes, switching to other combusted and/or non-combusted tobacco, or~     cessation of all tobacco containing products.~   "
119689|NCT02000908|"~     This is a 2-armed, randomized, sham-controlled, double-blinded clinical trial of~     photobiomodulation therapy using the Realief Therapy system. The patients will be randomized~     in a 3:4 ratio to treatment or sham arms.~   "
119690|NCT02000895|"~     Infants born preterm and of low birth weight are known to be at increased risk for early~     onset of cardiovascular and renal disease in adult life. This has been related to low nephron~     mass due to inadequate or early termination of glomerulogenesis in utero and during the~     perinatal period. Risks for subsequent development of hypertension and kidney disease include~     proteinuria, excessive weight gain during early life with insulin resistance and supplemental~     high calorie feedings. The long-term goal is for early diagnosis of those infants who are at~     risk for future development of hypertension and kidney disease so that the investigators~     might intervene to potentially avert progression to adult disease. The objective of this~     clinical trial is to acquire data on the natural history of neonatal kidney function and size~     in infants born preterm during the first 2 years of life. This will be done through the use~     of standard serum and urine markers as well as non-invasive ultrasound technology. The~     central hypothesis of this clinical trial is that a subgroup of patients born preterm and of~     low birth weight will demonstrate early markers of kidney injury including elevated serum~     cystatin C, proteinuria and low kidney size. This hypothesis has been formulated on the basis~     of preliminary data from our group studying this question retrospectively in older children~     born prematurely who have developed overt kidney disease. The rationale for the proposed~     research is to develop early serum and demographic markers of pre-clinical kidney disease so~     that early intervention can occur. The proposed clinical trial is innovative because it will~     investigate the risk factors for kidney dysfunction at a pre-clinical stage with the idea of~     gaining more knowledge regarding therapeutic interventions. In addition, the study will~     assess serum cystatin C as a surrogate test for glomerular filtration rate which could~     indicate worsening kidney function at an earlier stage than serum creatinine.~      The proposed research is significant because it is expected to identify at-risk patients for~     future renal impairment and to prospectively monitor the persistence of proteinuria and its~     effect on kidney function in the short term.~   "
119691|NCT02000882|"~     This is a study to determine the safety and effectiveness of BKM120 plus capecitabine in~     breast cancer patients with brain metastases.~      Both capecitabine and BMK120 have previously shown activity in patients with breast cancer.~     Like capecitabine, BMK120 is also effective in crossing the blood brain barrier making it a~     preferred candidate for its evaluation in patients with metastatic breast cancer (MBC).~   "
119692|NCT02000869|"~     People with CKD have higher prevalence of cardiovascular disease. The mechanism behind this~     increased risk is complex but there is strong evidence that changes in arterial stiffness~     play a central role. Arterial stiffness as measured by aortic pulse wave velocity (aPWV) and~     augmentation index (AIx), is a surrogate marker of cardiovascular organ damage, and is~     signiﬁcantly associated with the future risk of clinical events. In addition, aPWV is an~     independent and powerful predictor of all-cause and cardiovascular mortality in patients on~     dialysis. Reduction of aPWV, mainly by use of an ACE-inhibitor results in an improved~     survival in dialysis patients. These findings suggest that arterial stiffness is not merely a~     marker of arterial damage but a potentially reversible factor contributing to mortality in~     dialysis patients. There is strong evidence that arterial stiffness increases as glomerular~     filtration rate (GFR) falls. Conversely, arterial stiffness has also been established in a~     number of studies as a significant risk factor for CKD progression.~      In addition to arterial stiffness, elevated central aortic blood pressure and central pulse~     pressure have been shown to increase the risk of progression of CKD to ESRD. Central blood~     pressure is more strongly related than standard BP measured at the brachial arteries~     (brachial blood pressure) to concentric left ventricular hypertrophy and carotid artery~     hypertrophy as well as to future cardiovascular events.~      Cardiovascular disease remains the foremost cause of death post-kidney transplant. Although,~     successful kidney transplant has been shown to improve arterial stiffness post-transplant, we~     do not know to what extent the pre-transplant arterial stiffness and central aortic blood~     pressure and their improvement post-transplant impact the cardiovascular and allograft~     outcomes. In addition, it is unclear what transplant related factors are associated with~     improvement in arterial stiffness and central aortic blood pressure post-transplant.~      The goals of our study are:~        1. To determine if pre-transplant central blood pressure and aortic stiffness impact~          post-transplant cardiovascular and kidney allograft outcomes.~        2. To determine whether the changes in central blood pressure and aortic stiffness~          post-transplant impact cardiovascular and kidney allograft outcomes.~        3. To determine the factors associated with improved central aortic blood pressure and~          arterial stiffness post-transplant.~   "
119693|NCT02000856|"~     The study is a single center randomised, double-blind, placebo-controlled crossover study to~     assess the effects of beetroot juice in patients with pulmonary arterial hypertension.~   "
119694|NCT02000843|"~     Tympanoplasty -- conchal cavum approach is a modification of Heermann endural approach to~     repair broken eardrums. The Heermann approach is a well recognized procedure, in common~     clinical practise for years.~      The new approach has been used in patients after informed consent was obtained from each~     patient.~   "
119794|NCT01999543|"~     The study is designed to determine the extent to which a plant-based ingredient on different~     food formats affect blood glucose responses in healthy subjects~   "
119696|NCT02000817|"~     The aim of this Phase I/IIa study is to identify a safe and tolerable dosage regimen of~     intravenously administered otelixizumab. In addition, the C-peptide decline in new onset type~     1 diabetes mellitus (NOT1DM) patients and possible immunological mechanisms will be~     investigated with a view to identifying trends and early immunological biomarkers which could~     predict response in halting/slowing Beta-cell destruction in this patient population.~      This exploratory study will explore the safety and tolerability between the well tolerated~     but non-efficacious cumulative dose of 3.1 mg and a cumulative dose of 48 mg at which~     efficacy based on C-peptide analysis was demonstrated, albeit with evidence of Epstein Barr~     Virus (EBV) reactivation and Cytokine Release Syndrome (CRS). Exploration of the tolerability~     dose response is considered a necessary first step to determining the therapeutic index of~     otelixizumab.~   "
119697|NCT02000804|"~     This study is to evaluate pharmacokinetics (PK), pharmacodynamics (PD) and safety of 160 mg~     enteric-coated micronised free base darapladib in healthy Chinese subjects.~   "
119698|NCT02000791|"~     it is compared that laryngeal mask insertion with standard technique and laryngoscopic~     technique~   "
119699|NCT02000778|"~     The overall prevalence of Ovarian Cancer in the United States according to the US SEER~     Registry is 182,710 women. Ovarian cancer also has the highest mortality rate of the~     gynecological cancers. The overall five-year survival rate is 45% and for Stages III and IV~     it is only 20-25%. The majority of these are aged 50 years or older, but a few girls less~     than 10 years of age have been diagnosed with ovarian cancer. This risk increases with age~     and decreases with numbers of pregnancies.~      The prognosis for many carcinomas is dependent on the extent of surgical resection. At~     present, the ability to perform a complete resection with negative margins is limited by the~     investigator's ability to palpate and visualize the tumor and its borders. In many cases, a~     more radical resection than necessary is performed in order to provide assurance that~     negative margins are achieved. This approach may also increase complication rates, as well as~     short- and long-term morbidity. It is desirable to improve visualization of primary tumors~     and occult metastases in real time, during surgery. The use of fluorescent probes that~     recognize cancer-specific antigens, in conjunction with a clinical imaging system, is under~     investigation.~      Ovarian cancer is a prototypic disease for this type of clinical imaging system called~     intra-operative imaging. Except in Stage IV, the tumors are confined to the pelvis or abdomen~     and typically involve extensions or implants onto pelvic or abdominal organs or membranes.~     Tumor debulking surgery is common early in the disease process as many of the tumors can be~     identified by appearance or feel in the skilled surgeon's hands. The major problems are that~     tumors can be diffuse and numerous, of various sizes, and often not readily visible in the~     surgical field.~      Over 90-95% of serous ovarian cancers express folate receptor (FR)-alpha, making this~     receptor an ideal target for marking most ovarian cancers. Folate is the prototypic agonist~     at the FR-alpha with potential uses for imaging and targeted therapeutic~     strategies.Chemotherapy does not affect FR-alpha expression in ovarian cancer specimens~     examined by immunohistochemistry, so prior treatment is unlikely to affect utility of~     FR-alpha agonists as imaging or therapeutic agents.~   "
119700|NCT02000765|"~     This is an open-label, non-randomized, two-period, cross-over, mass balance study that will~     evaluate the recovery, excretion, and pharmacokinetics of a single intravenous (IV) dose of~     [14C]-GSK2140944 (Period 1) and a single oral dose of [14C]-GSK2140944 ( Period 2) in 6~     healthy male subjects. The results from this study will aid in the design of future clinical~     pharmacology studies such as the thorough corrected QT interval study, special population~     studies (renal, hepatic, critically ill patients), potential drug interaction studies, and~     will help to establish safe and efficacious intravenous and oral dosing regimens.~   "
119701|NCT02000752|"~     In this study, a single blind randomized trial is carried out in order to compare placental~     detachment times when Ren Mai 6 is stimulated and when a different placebo point is used. So,~     a lower detachment time is assumed to be related to a higher uterine contraction, and,~     therefore, a decrease in the hemorrhage postpartum. We focus on measuring the time it takes~     to placental delivery due to the fact that, if this point promotes the uterine contraction,~     then the placental delivery will be produced in a short time. Thus, this technique could~     decrease the hemorrhage postpartum.~      The principal outcome of the study is the placental expulsion time. This time is measured by~     the midwife who is responsible of the birth, and it considers the time passed between the~     delivery of the newborn and the complete expulsion of the placenta.~      Concerning the secondary outcomes, the application of real acupuncture in Ren Mai 6 point,~     and sham acupuncture in the placebo point are considered. Their study is derived from the~     statistical analysis of the results of the principal outcome. The existence of pain related~     to the treatment and the degree of satisfaction of the mother is also a secondary outcome,~     analyzed by the survey that the midwife carries out no more than 2 hours after the labor. At~     last, it is important to highlight that the degree of satisfaction of the midwife is also~     considered as a secondary outcome, since it is registered in the same survey.~   "
119702|NCT02000739|"~     Genetic mutations associated with cancer are being discovered and new treatments are being~     created to treat people whose cancer tumors have certain genetic mutations. Genetic~     sequencing of a tumor can be done, and in this study that information is sent to a company~     called N-of-One. They will match each patient's tumor's genetic profile to targeted~     therapies. The targeted therapies may be use of FDA-approved drugs, off-label use of~     FDA-approved drugs, or use of experimental drugs in clinical research studies open at various~     locations in the region.~      The purpose of the study is to compare the length of time it takes for a tumor to grow in~     people who receive the standard treatment for metastatic cancer to the length of time it~     takes for a tumor to grow in people who receive a drug specifically targeted for their~     cancer's genetic mutation.~      Investigators will do a kind of genetic testing called DNA sequencing. Everyone who takes~     part in this trial will have genetic testing done on their cancer tumor tissue here at~     Dartmouth. The results of the DNA sequencing will be sent to N-of-One as noted above.~      The treatment participants get will depend on the results of the DNA sequencing and the~     availability of targeted therapies that match the genetic profile of the tumor identified by~     the DNA sequencing.~      If there is no genetic mutation that can be identified with current DNA sequencing,~     participants will receive the standard treatment for metastatic cancer.~      If there is a genetic mutation that can be identified with current DNA sequencing and a drug~     has been developed for this mutation, participants may be able to receive that drug. If there~     is more than one drug available, the participant and his/her oncologist will decide which is~     the best one for the participant.~      Because there are many drugs that may be used in this study, the investigator cannot advise~     in advance whether or not the drug a participant might receive has been approved by the U.S.~     Food and Drug Administration (FDA).~   "
119703|NCT02000726|"~     Current medical therapies for depression take weeks to achieve full efficacy, and are~     ineffective in many patients or cause intolerable side effects, emphasizing the need for a~     deeper understanding of depression and its treatment. Identifying early brain biomarkers of~     treatments responses seems necessary to improve antidepressant treatment outcome. In this~     study we aim to detect early brain responses to a fast acting antidepressant-like treatment~     administered intravenously during a Real-Time Neurofeedback functional magnetic resonance~     imaging (MRI) Task to predict antidepressant treatment outcome in depression. At completion~     of the neuroimaging task, participants will enter a placebo-controlled clinical trial with a~     selective serotonin reuptake inhibitor (SSRI).~   "
119704|NCT02000713|"~     The investigators want to know if magnetic resonance imaging can accurately provide an early~     diagnosis of amyotrophic lateral sclerosis (ALS).~   "
121276|NCT01980069|"~     Investigators hypothesized that the surgical condition will be improved with the use of~     sugammadex in patients undergoing laryngeal microsurgery. Investigators will compare the~     effect of sugammadex and neostigmine on the surgical condition during laryngeal microsurgery.~   "
119708|NCT02000661|"~     Fractional flow reserve (FFR) is a test that can be performed at the time of heart~     catheterization. It measures the change in pressure across a narrowing in the heart artery~     during high flow situation, and provides reliable information about the functional severity~     of the narrowing. FFR measurements accurately predict whether a stent is needed, and is~     considered an excellent test before placement of stents to treat narrowed heart arteries.~     However, FFR is not used in every case because of the extra time needed and the associated~     device costs. Cardiac Services BC (an agency of Provincial Health Services Authority) is~     sponsoring this study to find out if FFR should be used in most cases (routine), rather than~     the current selective approach.~   "
119709|NCT02000648|"~     Observation study of patients with chronic rhinitis or chronic urticaria in Thailand~   "
119710|NCT02000635|"~     The leptospirosis evolves on an endemic mode in French West Indies and its incidence in 2011~     was de 61/100 000 inhabitants, 100 times more than the metropolitan France's incidence~     (0,47/100 000). If cases can arise all year long, periods of heavy rainfall are associated~     with the arisen of epidemic peaks Clinical presentation of leptospirosis include a wide range~     of symptoms: the most frequent form is a flu-like syndrome but more severe forms are~     described as meningitis, uveitis and classical severe presentation such as lung bleedings and~     liver-kidneys infringement (syndrome of Weil) which constitute the most severe forms of the~     disease.~      Currently , Polymerase chain reaction (PCR) is the only test who can provide a diagnostic~     confirmation during the first week of development and before the appearance of the first~     antibody.~      If the microagglutination test (MAT) is considered the gold standard test for diagnosis of~     leptospirosis. However it requires rending samples to the referent National center for the~     leptospirosis at Pasteur Institute in Paris while the antibodies do not appears until the~     second week of illness. A second sample is required 15 days after the first one, to confirm~     the diagnosis.~      In clinical practice , the technique of real-time PCR for the detection and quantification of~     pathogenic Leptospira during the first week of illness . The technique of diagnosis of~     leptospirosis by real-time PCR has been implemented and tested in 2007 at the University~     Hospital of Martinique and providing to the clinicians from 2008. The optimal duration of~     antibiotic therapy has not been studied and experts now recommend for a 7 to 10 days,~     regardless of the severity of the disease. The evolution of leptospiremia treated patients~     has not been studied to date.~   "
119711|NCT02000622|"~     This open label, randomised, controlled, multi-centre phase III study will assess the~     efficacy and safety of single agent olaparib vs standard of care based on physician's choice~     of capecitabine, vinorelbine or eribulin in metastatic breast cancer patients with gBRCA 1/2~     mutations.~   "
119712|NCT02000609|"~     The study aim is to compare the pharmacodynamic effects (cardiovascular effects- primary~     variable: Heart rate over 4 hours post dosing- ) after administration of BDP and formoterol~     administered as CHF 1535 100/6 NEXThaler DPI or CHF1535 pMDI at two different dose levels.~   "
119713|NCT02000596|"~     This is a phase II study that combines Trastuzumab with Pertuzumab to see how it works in~     women age greater than 60 who have been diagnosed with HER2/neu overexpressed locally~     advanced and/or metastatic breast carcinoma.~   "
119714|NCT02000583|"~     The purpose of this study is to learn about the possible benefits of aerobic exercise in~     controlling or reducing the amount of amyloid present in the brain, reducing changes in brain~     structure that may lead to Alzheimer's Disease (AD), and increasing cognitive ability in~     individuals that have amyloid deposits and are at risk to develop AD.~   "
119715|NCT02000570|"~     Intraoperative optimization of cardiac output using goal directed fluid challenge is~     associated with better outcome. Dynamic preload dependence indicators are well validated~     during surgery in supine position. Positioning from supine to sitting position under~     anesthesia is responsible of several hemodynamic changes. Predictability and cut-off values~     of dynamic preload dependence indicators during surgery in sitting position are unknown. The~     objective of this prospective study is to evaluate ability of three dynamic preload~     dependence indicators, i.e. PPV (Pulse Pressure Variation), SVV (Stroke Volume Variation) and~     PVI (Plethysmographic Variability Index), during neurosurgery in sitting position.~   "
119716|NCT02000557|"~     The present day social setup considers facial charisma as an important physical~     characteristic. The facial characteristics of an individual are measured through~     anthropometry, photogrammetry, computer imaging and cephalometric radiographs. Cephalometric~     radiographs offer significant diagnostic information regarding the association between the~     dental and skeletal structures. By means of photogrammetric measurements, a fresh diagnostic~     resource is accessible to the orthodontist which permits an intangible, radiation free~     attainment of measure points of soft tissue with no instrumental expense and radiation to the~     patient.~      Orthodontic patients range from adolescents to senior citizens and originate from an~     assortment of populations, thus an extensive series of representative norms will be ideal.~     Knowledge of the normal dentofacial outline of every group will make certain better success~     of treatment to set up the best possible facial agreement. Hence, it is extremely important~     to assess the soft tissue profile of a patient as it is one of the most vital components of~     orthodontic diagnosis and treatment planning.~      The purpose of the present study is to evaluate the photographic characteristics of soft~     tissue facial profile of patients with class II malocclusion as ethnic differences have been~     found to be reported in the literature. It is hypothesized that soft tissue facial~     characteristics on lateral profile photographs and lateral cephalometric radiographs in a~     sample of local population with class II malocclusion are closely related.~   "
119717|NCT02000544|"~     The purpose of this clinical research study is the design of a novel modular hybrid system~     extracorporeal circulation circuit for open heart procedures that could easily be converted~     from a closed to a semi-closed circuit according to the indication. This could expand the~     potential of minimal extracorporeal circulation and could ultimately become the new standard~     circuit in performing every type of cardiac surgery.~   "
119795|NCT01999530|"~     The purpose of this study is to find out whether short term treatment with a antihypertensive~     medication prazosin, can influence the levels of a dopamine in the brain. We will examine the~     levels of dopamine in the the brain using Positron Emission Tomography (PET) and Magnetic~     Resonance Imaging (MRI). We hypothesize that there will be no significant changes in dopamine~     levels in healthy individuals taking prazosin.~   "
119718|NCT02000531|"~     This trial is an extension to ENSURE, a study of erlotinib versus gemcitabine/cisplatin~     combination chemotherapy as the first-line treatment for patients with non-small-cell lung~     cancer (NSCLC) with mutations in the tyrosine kinase domain of EGFR.~      This study is designed to examine the efficacy of erlotinib versus gemcitabine/cisplatin as a~     second-line treatment in NSCLC patients from the ENSURE trial (NCT01342965). Patients~     previously treated with gemcitabine/cisplatin will be given erlotinib daily until disease~     progression or unacceptable toxicity occurs. Patients previously treated with erlotinib will~     be given cisplatin on Day 1 and gemcitabine on Days 1 and 8 of 3-week chemotherapy cycles~     until disease progression, unacceptable toxicity or up to 4 cycles (whichever comes first).~   "
119719|NCT02000518|"~     Acute neurological deficit in metastatic spinal cord compression is an emergency condition in~     radiation oncology. Despite some reports about the high efficacy of radiation treatment for~     oncological emergencies, a standard of care is not well defined, especially the time interval~     of immediate RT after deficit, and neurological outcome with respect to poor survival in~     non-small cell lung cancer patients. The objective of this trial is to investigate~     neurological outcome after emergency radiotherapy in metastatic spinal cord compression of~     non-small cell lung cancer patients with acute neurological deficit.~   "
119720|NCT02000505|"~     Comparison of various methods to improve the quality of CPR~   "
119721|NCT02000492|"~     Inactivity among schoolchildren is a challenge to public health and for the municipality in~     particular. This study´s aim is to evaluate the cognitive and physical as well as social and~     fitness adaptations, and learning outcomes of short- and long term ball training for 9-11~     years old girls and boys, and to determine to what extend the organisation (5x12 minutes og~     3x40 minute a week) and type of training (ball games, circuit training or running) influence~     the magnitude of response.~   "
119722|NCT02000479|"~     The purpose of this study is to investigate the effects of a combined training programme on~     insulin resistance, exercise tolerance, muscle strength, body composition and cardiac~     function in chronic heart failure patients.~      It is assumed that the above mentioned clinical parameters will improve due to physical~     exercise.~   "
119723|NCT02000466|"~     The purpose of this pregnancy registry study is to detect and describe any abnormal pregnancy~     outcomes in women intentionally or unintentionally vaccinated with FluLaval Quadrivalent. The~     Registry requires voluntary, prospective reporting of eligible pregnancies by patients and~     health care providers (HCPs). Data such as vaccination with FluLaval Quadrivalent during~     pregnancy or within 28 days preceding conception, potential confounding factors (such as~     exposure to other medications) and information related to the outcome of the pregnancy will~     be collected prospectively.~   "
119724|NCT02000453|"~     This is an open label exploratory study to investigate the safety of 400 milligram (mg )~     twice a day (b.i.d.) GSK2586184 in patients with moderate to severe, active ulcerative~     colitis (UC). Study medication will be administered orally (as tablets), twice daily, for up~     to 8 weeks (56 days). Study medication will be taken with food. Each subject will have 6~     out-patient visits: Screening (Day -30 to -1); Baseline and Start of treatment (Day 1); Week~     2 (Day 14); Week 4 (Day 28); Week 8 (Day 56); and Follow-up (Week 12; Day 84). Visit windows~     for weeks 2, 4 and 8 will be + 2 days. The primary objective of this study is to assess the~     safety and tolerability of GSK2586184. The primary endpoints to measure safety are laboratory~     tests (including haematology, clinical chemistry and serum creatinine), vital signs, 12-lead~     electrocardiogram (ECG), physical examination, and adverse event reporting. These are~     standard measurements to evaluate safety.~   "
119725|NCT02000440|"~     This is a single-arm, multicenter, open-label Phase II, proof-of-mechanism study to evaluate~     the efficacy, safety, tolerability and pharmacokinetics of losmapimod in approximately 21~     subjects with primary (idiopathic) focal segmental glomerulosclerosis (FSGS) and substantive~     proteinuria as indicated by a Urinary protein/creatinine Up/c ratio >=2 gram/gram (g/g) or 24~     hr urine protein >=2 g/day. Losmapimod will be orally administered twice daily over a 24-week~     treatment phase followed by a 12-week follow-up for safety and relapse assessments.~   "
119726|NCT02000427|"~     The primary objective is to evaluate the rate of complete remission/complete remission with~     partial hematological recovery (CRh*) in adults with relapsed/refractory Philadelphia~     chromosome positive (Ph+) B-precursor acute lymphoblastic leukemia (ALL) who receive~     blinatumomab.~   "
119727|NCT02000414|"~     Peritoneal infection is still a frequent complication in peritoneal dialysis patients . In~     France, It contributes to the technique failure, responsible for about 20% of cases of~     transfer in hemodialysis. The risk of direct mortality is estimated at 1 to 6% according to~     studies. Peritoneal infection is involved in the dysfunction of the peritoneal membrane.~      Based on the recommendations of the International Society for Peritoneal Dialysis, the~     intraperitoneal route is preferentially recommended. For many antibiotics, pharmacokinetics~     (intravenous and intraperitoneal) was studied and protocols for IP administration were~     validated.~      Daptomycin, is a cyclic lipopeptide natural, active only on Gram-positive bacteria. It is~     presented as an alternative to vancomycin in infections resistant pathogens. The stability of~     daptomycin in peritoneal dialysis fluids (PDF) has been tested, and antimicrobial activity as~     well.~      Seven patients were treated with daptomycin intraperitoneally successfully. But no study has~     reported pharmacokinetics of daptomycin via the IP route. We propose a pharmacokinetic study~     of daptomycin administered intraperitoneally in 12 patients on CAPD and with Gram-positive~     peritoneal infection.~   "
119728|NCT02000401|"~     Intranasal Ketorolac tromethamine has a potential role as a short term pain management tool~     for Interstitial Cystitis without the risk and undesirable effects of narcotics.~   "
119729|NCT02000388|"~     To evaluate the efficacy, tolerability and safety of intranasal ketorolac tromethamine~     (SPRIX) as an option for pain management in post vasectomy patients.~   "
119763|NCT01999946|"~     The purpose of this study is to compare the effectiveness of extended-release naltrexone~     (XR-NTX) vs. enhanced treatment-as-usual (TAU) among opioid dependent adults leaving NYC~     jails. In parallel, we propose to recruit a matched, quasi-experimental methadone cohort,~     which will result in a naturalistic comparison of XR-NTX vs. an established jail-based~     methadone treatment program standard-of-care. Our primary aim is to compare time-to-relapse~     among participants treated with XR-NTX vs. randomized TAU controls and time-to-relapse among~     XR-NTX arm vs. jail-based MTP participants, following release from jail. Secondary aims will~     compare related opioid treatment outcomes post-release across all arms.~   "
119730|NCT02000375|"~     A phase II non randomized study evaluating the role of Androgen Receptors as Targets for~     therapy of pre-treated postmenopausal patients with ER/PgR-negative/AR-positive or ER and/or~     PgR-positive/AR-positive metastatic breast cancer.~      Study Design: Multicentric, Open-label not randomized trial.~      Description of Study Treatment:~      Daily oral administration of DHEA (Dehydroepiandrosterone) at the dosage of 100 mg/die in~     combination with a daily oral administration of anastrozole at dosage of 1 mg/die or~     letrozole at the dosage of 2.5 mg/die or exemestane at the dosage of 25 mg/die without~     interruption until discontinuation for progression of disease, unacceptable toxicity or~     discontinuation/withdrawal of participants from study treatment.~      Number of Subjects:~      12 patients per group in the first step; if the number of responders is greater or equal to~     2, recruitment will continue up to a total of 35 patients (per group).~      For the biological part, we will evaluate:~        1. Correlation between AR expression and clinical and biological features (tumor size,~          nodal status, histotype, grading, proliferative index, ER, PgR, HER2)~        2. Evaluation of AR expression on primitive and/or metastatic site in the two distinct~          populations of patients: ER/PgR- negative/ARpositive and ER-positive and/or~          PgR-positive/AR-positive~        3. Evaluation of ER, PgR, HER2 expression on tumor cells of metastatic site (when it is~          possible) and comparison with the same features of primitive tumor.~        4. CTCs analysis in term of molecular characteristics (gene expression and mutations) and~          functionality (vitality and tumorigenicity).~        5. Prognostic and predictive role of Circulating Tumor Cells (CTC) evaluated at baseline~          before study treatment and at the moment of discontinuation of treatment.~   "
119731|NCT02000362|"~     The purpose of phase I clinical trial is to evaluate safety and efficacy in subjects with~     moderately active Crohn's disease after injection for 28days.~      The purpose of phase IIa clinical trial is to determine therapeutic safety and efficacy of~     FURESTEM-CD Inj. which is based on Crohn's disease activity index(CDAI)<150 after injection.~   "
119732|NCT02000349|"~     The investigators propose to perform a clinical randomized trial to evaluate the effect of a~     frozen-thawed embryo transfer and a fresh embryo transfer on pregnancy and implantation~     rates; with the added benefit of a blastocyst biopsy and whole chromosome analysis by Next~     Generation Sequencing (NGS).~   "
119733|NCT02000336|"~     Although cortisone is widely used in the treatment of patients with early rheumatoid~     arthritis, the best dosage is not known. Therefore we will compare two standard prednisolon~     starting dosages and placebo in the treatment of patients with early active rheumatoid~     arthritis on the background of the established therapy with methotrexate. In total 450~     patients will be included into the study. Two different treatment arms starting with 10 or 60~     mg of prednisolone, and one placebo arm. Duration of intervention is 12 weeks. In parallel,~     all patients start medication with methotrexate, usual dosage 15 mg/week. Primary efficacy~     endpoint is progression of radiographic damage after one year compared to baseline. Safety~     monitoring is performed.~   "
119734|NCT02000323|"~     to compare different time points for enteral nutrition in SAP patients~   "
119735|NCT02000310|"~     The lysosome is a specialized part of the cell that functions to degrade metabolic wastes in~     the cell. Defects in the functioning of the lysosome result in accumulation and subsequent~     storage of such metabolic wastes. These defects lead to conditions known as lysosomal storage~     diseases (LSD). LSDs are caused by inherited genetic mutations and there are over 40~     genetically distinct lysosomal storage diseases. Within each specific lysosomal storage~     disease there are variances in severity of disease, age of onset, and clinical presentation.~     Though the genetic mutations contributing to the disease have been largely clarified, the~     molecular and cellular mechanisms that contribute to variations in each distinct LSD remain~     unclear. With this study we intend to better understand at the cellular and molecular level~     how the accumulation and storage of metabolic wastes in the lysosome affect the clinical~     manifestation of LSDs, to detect changes in these mechanisms upon treatment administration,~     and to correlate these results to genetic information. The knowledge obtained from this~     research study could lead to better ways to diagnose and treat lysosomal storage diseases.~   "
119736|NCT02000297|"~     This study is conducted to determine whether a new synthetic bone substitute is better than~     allogenic bone graft for addressing bone defect in medial open wedge high tibial osteotomy in~     terms of postoperative pain, postoperative bleeding, operation time and bone healing. The~     investigators hypothesized the new synthetic bone substitute would bring better outcomes in~     the outcome variables mentioned above.~   "
119737|NCT02000284|"~     Researchers at Arkansas Children's Hospital Research Institute are conducting a study about~     mitochondrial function in children. The study involves 2 visits to Arkansas Children's~     Hospital with fasting blood draws and behavioral assessments.~      ENROLLMENT IS LIMITED AT THIS TIME TO MITOCHONDRIAL DISEASE AND TYPICALLY DEVELOPING~     POPULATIONS~      Patients may be eligible to participate if he or she is between the ages of 0‐17 years~      And falls into one of the following groups:~        -  Is Typically Developing with no known problems OR~        -  Has a history of Developmental Delay OR~        -  Has been diagnosed with an Autism Spectrum Disorder OR~        -  Has a history of a Mitochondrial Disease.~      There is no cost for visits or study‐related exams. Participants will receive gift cards as~     compensation for their time.~      For further information, please contact the program manager, Leanna Delhey, at~     ldelhey@uams.edu or 501-364-4519~   "
119738|NCT02000271|"~     Vaginal packing is used routinely following vaginal reconstructive surgery. Despite little~     data to support the practice, purported benefits include reduced pelvic fluid accumulation or~     blood loss. Patients often complain of discomfort associated with the packing or its removal.~      This randomized controlled trial seeks to document differences in subjective impressions of~     pain in women undergoing vaginal repairs treated with and without packing. The investigators~     also aim to assess differences in postoperative fluid collection in those with and without~     packing.~   "
119796|NCT01999517|"~     Contrast-induced nephropathy (CIN) is a complication of percutaneous coronary angiography~     that occurs in about 10 to 20% of patients exposed to contrast media. Iodinated contrast is~     used during coronary angiography to see the coronary arteries. It has been shown that~     exposure to this agent may cause kidney injury. CIN usually goes away on its own but in some~     high risk patients it progresses into renal failure.~      This research study offers a new possible option to prevent CIN. We propose that if~     intravenous nitroglycerin is given before the procedure it may lower the chances of~     developing contrast-induced nephropathy.~   "
119739|NCT02000258|"~     Purpose: To find out whether the clinical and MRI findings two years after anterior cruciate~     ligament (ACL) reconstruction were associated with each other so that MRI-based graft~     invisibility in the anteromedial (AM) graft would have an impact on anteroposterior stability~     of the knee, and MRI-based posterolateral (PL) graft invisibility on rotational stability of~     the knee.~      Methods: 75 patients. One experienced orthopaedic surgeon performed all double-bundle (DB)~     ACL reconstructions. Two independent examiners made the clinical examinations at the two-year~     follow-up: clinical examination of the knee, KT-1000, International Knee Documentation~     Committee (IKDC) and Lysholm knee evaluation scores and IKDC functional score. The MRI~     evaluations were made by two musculoskeletal radiologists separately and the means of these~     measurements were used.~   "
119740|NCT02000245|"~     The purpose of this study is to evaluate the effect of verbal expression of sympathy and~     touch on anxiety of patients undergoing fiberoptic bronchoscopy~   "
119741|NCT02000232|"~     Measure if FDA regulation of Colchicne in 2009 has resulted in safer use in clinical~     settings.~      Our study will assess the impact of this Initiative on colchicine use and will provide data~     that supports its continuation and expansion.~   "
119742|NCT02000219|"~     The purpose of this study is to determine if Oxalobacter formigenes is effective at lowering~     plasma oxalate levels in patients with primary hyperoxaluria who are on dialysis.~   "
119743|NCT02000206|"~     A prospective, randomized, patient-blinded comparison of the safety and efficacy of conscious~     sedation by propofol/alfentanil with propofol/ketamine in patients undergoing flexible~     fiberoptic bronchoscopy.~   "
119744|NCT02000193|"~     This is a prospective, single arm phase II study to evaluate the efficacy and safety of~     fulvestrant as a maintenance hormone therapy after first-line chemotherapy for postmenopausal~     HR positive advanced breast cancer.~   "
119745|NCT02000180|"~     It is hypothesized that a progressive simulated learning strategy will result in better~     global clinical performance (e.g., technical, communication) and transfer of endoscopic~     skill, as compared with a high-fidelity simulation strategy.~   "
119746|NCT02000167|"~     The purpose of this study is to determine whether a relationship exists between gene~     deletion(s) specific to the mitochondrial electron transport chain and presentation of~     clinical characteristics in patients with Phelan-McDermid Syndrome (PMS).~   "
119747|NCT02000154|"~     This is an extension study study to investigate long term safety of SyB L-1101 when~     administered intravenously every 4 weeks to the patients who have completed 8 cycles in the~     study 2011005 whose purpose is to investigate tolerability of SyB L-1101 when administered~     intravenously in patients with recurrent/relapsed or refractory myelodysplastic syndrome.~     Antitumor effects will also be investigated in this study.~   "
119748|NCT02000141|"~     To enhance understanding of the risk factors for AMN, improve lesion assessment and~     prediction of submucosal invasive cancer, improve endoscopic resection efficacy, reduce~     complications of WF-EMR and improve the understanding of the progression of large lesions to~     cancer~   "
119749|NCT02000128|"~     1. Purpose: to investigate the effect of bioimpedance analysis(BIA) guided fluid management~          versus experiential way on clinical outcome in peritoneal dialysis patients.~        2. Design: prospective,randomized,controlled,single center study~        3. Study hypothesis: Patients on peritoneal dialysis are frequently hypervolemic, which is~          associated with increasing hazard of death and cardiovascular events. Bioimpedance~          analysis is a safe, and easy way, which appears to be more useful and sensitive than~          other techniques for assessing volume status in dialysis patients. Therefore we~          hypothesize that more concise and strict fluid management guided by BIA may help to~          improve patients' survival, decrease cardiovascular events and hospitalization rate.~        4. Objects: incident and prevalent patients with overhydration status.~             1. anticipated cases:240~             2. arms: all the patients are randomized into two arms.(BIA group/clinical group)~             3. observational time:12 months~        5. Primary Outcome: all cause mortality. Secondary Outcomes: technique survival,~          cardiovascular events, peritonitis, residual renal function.~   "
119750|NCT02000115|"~     The PORTICO clinical trial is a prospective, multi-center, randomized, controlled clinical~     study, designed to evaluate the safety and effectiveness of the SJM Portico Transcatheter~     Heart Valve and Delivery Systems (Portico) via transfemoral and alternative delivery methods.~   "
119751|NCT02000102|"~     Patients with diabetic macular edema who were switched to aflibercept after having been~     treated with bevacizumab or ranibizumab were retrospectively reviewed to assess for visual~     acuity and anatomic outcomes.~   "
119752|NCT02000089|"~     Johns Hopkins clinical research office quality assurance group will monitor and audit this~     study at Johns Hopkins. The Sub Investigator at each site will be responsible for internal~     monitoring at their site.~   "
119753|NCT02000076|"~     The main purpose of this study is to investigate the effects of partial sleep deprivation~     (PSD) on resting state brain connectivity, emotional contagion, empathy, and emotional~     regulation.~   "
119754|NCT02000063|"~     A single long-term follow up assessment of an established multi-centre, prospective~     longitudinal cohort study of patients for clinical, psychosocial, immunovirological outcomes~     4 to 8 years after previous treatment for recently acquired hepatitis C virus infection.~   "
119764|NCT01999933|"~     The present study is a randomized, control, phase II/III study of early stage (FIGO Ia2-IIb)~     cervical cancer after radical hysterectomy in Northwest China treated with radiotherapy or~     concurrent chemoradiotherapy based on the surgical-pathological risk factors. All the~     patients received whole pelvis radiation and were divided into three groups according to~     adjuvant chemotherapy: concurrent chemotherapy with cisplatin weekly (40mg/m2) , concurrent~     chemotherapy with docetaxel plus cisplatin tri-weekly (75mg/m2), or concurrent and adjuvant~     chemotherapy with docetaxel plus cisplatin tri-weekly (75mg/m2). The effectiveness, and side~     effects will be evaluated according to Standard WHO response criteria, and NCI common~     toxicity criteria for adverse events(NCI-CTC-AE) V3.0.~   "
119765|NCT01999920|"~     The purpose of this study is to determine whether Vilazodone (Viibryd), an SSRI and 5HT1a~     receptor agonist, is effective in treating Adult Separation Anxiety Disorder over a 12-week~     treatment course.~   "
119797|NCT01999504|"~     The effects of two palaeolithic-type meals will be assessed with respect to a panel of gut~     hormones, satiety, blood glucose and insulin levels as compared to a meal constructed along~     the lines of the world Health Organisation dietary recommendations~   "
119755|NCT02000050|"~     Phase II study of up-front chemotherapy and neo-adjuvant shortcourse radiotherapy for~     resectable rectal carcinoma.~      Study Design: Phase II, open-label, single-arm, multi-centre study.~      STUDY PRODUCT,DOSE,ROUTE,REGIMEN AND DURATION OF ADMINISTRATION:~        1. Neoadjuvant Treatment (pre-operative chemo-radiotherapy regimen):~           FOLFOX4* 2 cycles (WK1+WK3) - Tomotherapy** (WK5) - FOLFOX4* 2 cycles (WK7+WK9)~           * Oxaliplatin 85 mg/m2 iv: day 1 Levofolinate 100 mg/m2 iv: day 1-2 5-fluorouracil 400~          mg/m2 iv in bolus and 600 mg/m2 iv infusion over 22h: day 1-2 Every cycle will last 2~          weeks (approximately 48 hours of treatment infusion and 12 days of rest).~           ** 25 Gy in 5 consecutive fractions, one fraction per day in 5 days on CTV (Clinical~          Target Volume) at the isodose of the 95% of the total dose. The treatment plan will be~          elaborated at the work-station dedicated to the Helicoidal Tomotherapy. The treatment~          could be planned also with linear accelerator with IGRT-IMRT technique or VMAT~          technique.~        2. Restaging (week 11)~        3. Surgery (week 12-16) with Total Mesorectal Excision (TME)~        4. End Of Treatment (week 16-32)~        5. Adjuvant therapy (The maximum interval between surgery and start of adjuvant therapy~          should be 8 weeks):~        6. FOLFOX4* 8 cycles (every 2 weeks)~      Study Duration: about 5 years. Enrollment period: 36 months. Treatment period: about 8~     months. Follow-up: 1 year.~      NUMBER OF SUBJECTs:~      · Step A: a maximum of 6 patients. 6 evaluable patients are needed to assess toxicity. If 1~     toxicity resulting in discontinuation of treatment will be observed in 6 patients, the~     treatment can be considered safe (with a confidence > 90%).~      If 2 or more toxicity resulting in discontinuation of treatment on 6 patients, the study will~     be stopped because not safe and another type of radiotherapy schedule must be designed.~      · Step B: a total of 50 patients is required to be recruited in 2 years (including patients~     enrolled in Step A).~      The goal is to achieve a proportion of at least 15% of patients with a complete pathological~     response with the new radiochemotherapeutic treatment.~   "
119756|NCT02000037|"~     It is known that the care that is offered to overweigh of class I obese people leads to an~     initial weight loss.~      However, after 12 months, people start to gain their weight back. French National Authority~     for Health suggests that physicians warn their patients against restrictive diets that can~     are the origin of weight's fluctuation can be health threatening. This weight regain is~     linked to numerous factors, mainly dietary compensation phenomenon tied to cravings (Lecerf,~     2013. Obésité : pourquoi les regimes échouent-ils ? Nutr Clin Metab (in press)).~      Due to the difficulties to keep the weight loss, it seems interesting to consider~     alternatives like reflexotherapy. This method seems to act in reducing the dietary urges~     causes by stress, by cravings or by frustration.~      This technique would allow to re-establish normal hormones' or neurotransmitters'~     concentrations mainly involved in the food intake.~      This could be a complementary response to the limits of the classic treatments for weight~     maintenance management, but it needs to be confirmed by a specific study.~   "
119757|NCT02000024|"~     This study is a randomized pilot study to assess the applicability of the Weight Watchers~     model for lifestyle modification to the primary prevention of type 2 diabetes. The approach~     developed by Weight Watchers to achieve weight loss is based on similar nutritional~     principals and techniques used in the Diabetes Prevention Program (DPP) lifestyle~     intervention; monitoring food intake, exercising calorie control, setting modest weight loss~     goals and using physical activity.~   "
119758|NCT02000011|"~     The curative treatment of thoracic (lung and oesophagus), digestive (gastric, pancreatic,~     hepatic, colorectal), and urologic (renal, bladder, prostatic) cancers needs a surgical~     resection. For patients aged of 70 years old and more, this surgery is associated to an~     increased morbid-mortality especially because of more frequent co-morbidities. Comprehensive~     geriatric assessment (CGA) allows distinguishing patients for whom a resection surgery can be~     complicated by high morbid-mortality or a loss of autonomy. It has been proved that for old~     patient population without cancer, CGA associated with a geriatric intervention plan (GIP)~     allows autonomy preservation, decrease of institution admission, and survival improvement.~     The reference study showed that a CGA associated to a GIP improves survival of old patients~     who had a cancer surgery. However this study included patients from 60 years old and the GIP~     consisted in 3 home visits and 5 phone calls during the 4 weeks following hospital discharge.~      We propose to perform a prospective and randomized study to evaluate the impact of a CGA with~     GIP in 70 years old and more patients with a thoracic, digestive or urologic cancer~     resection, respectively 1, 3, 6 and 12 months after discharge. CGA and GIP will focus on 8~     distinct fields: autonomy, co-morbidities, co-medication, mobility, nutritional status,~     depression, cognitive function and social status. The impact of such a strategy on autonomy~     and survival has never been studied.~   "
119759|NCT01999998|"~     Chemotherapy followed by radiotherapy is used to treat early stage lymphomas with excellent~     cure rates. However, a significant proportion of these patients develop cancers and heart~     diseases years later as a result of the radiotherapy. Therefore, there is a move to reduce~     radiation exposure without compromising cure rates. Radiotherapy is planned using a CT scan~     taken following chemotherapy when many of the original sites of the lymphoma are no longer~     visible using a CT scan taken following chemotherapy when many of the original sites of the~     lymphoma are no longer visible.~      In order to safely minimise the volume treated with radiotherapy it is necessary to~     accurately reconstruct the extent of the lymphoma prior to chemotherapy on this 'planning' CT~     scan. A PETCT prior to chemotherapy is the best way of demonstrating the original extent of~     the lymphoma, but is taken in a different position to the radiotherapy treatment position.~     This aim of this study is to explore whether a PETCT scan taken prior to chemotherapy in the~     radiotherapy treatment position, in conjunction with advanced software to combine this scan~     with the subsequent radiotherapy planning CT, can be used to more accurately identify the~     lymphoma target. The study aims to recruit up to 20 patients with early stage Hodgkin~     lymphoma or high grade nonHodgkin lymphoma. A routine staging PETCT will be followed at the~     same session by a PETCT in the radiotherapy treatment position appropriate radiotherapy~     immobilisation devices. Participation in the study will not affect treatment decisions or the~     radiotherapy planning process. The PETCT in the radiotherapy planning position will be made~     available to the treating clinicians. The process of planning radiotherapy will not be~     systematically altered by the study. The study is aimed at determining how to improve the~     radiotherapy planning process in the future, in the hope of a reducing in the long term side~     effects of treatment whilst retaining high cure rates.~   "
119760|NCT01999985|"~     The purpose of this study is to:~        -  Find out if the study drugs Afatinib and Dasatinib can be safely given together to~          patients with lung cancer~        -  Learn how these two drugs work in cancer cells when they are combined~        -  Learn more about the side effects of these two drugs when combined~        -  Find the highest doses of the study drugs Afatinib and Dasatinib that can be given~          safely without causing serious side effects~   "
119761|NCT01999972|"~     Despite the success of anti-angiogenic therapy in multiple treatment settings, a fraction of~     patients are refractory to vascular endothelial growth factor (VEGF) inhibitor treatment,~     while the majority of patients will eventually develop evasive resistance. It is proposed~     that mesenchymal-epithelial transition factor (c-MET) and its ligand hepatocyte growth factor~     (HGF or scatter factor) contribute to VEGF inhibitor resistance, such that combining a c-MET~     inhibitor with a VEGF inhibitor will provide additional clinical activity compared to VEGF~     inhibitor alone. This hypothesis will be tested using the cMET/ALK inhibitor, crizotinib, in~     combination with the VEGF inhibitor, axitinib.Since this will be the first study of axitinib~     given in combination with crizotinib, the study will primarily assess the safety and~     tolerability of the combination regimen.~   "
119762|NCT01999959|"~     To demonstrate a possible beneficial impact of pertubation we designed a randomized~     prospective study, in which uterine washing was administered prior to insemination in~     patients diagnosed with unexplained infertility.~   "
119766|NCT01999907|"~     Viral infections are the main cause of asthma attacks in preschoolers, an age group with the~     highest rate of emergency visits due to asthma. While high doses of inhaled or oral~     corticosteroids provide benefits, these have been associated with adverse outcomes. Most~     asthmatic children have lower blood levels of vitamin D compared to non-asthmatic children.~     Low vitamin D level has been linked to more frequent and more severe asthma attacks as well~     as with higher dose requirement of inhaled corticosteroid. Recent studies show that vitamin D~     supplements can reduce the number of asthma attacks triggered by viral infections in~     children. Unfortunately, most people forget to take vitamin D every day during the fall and~     winter season as recommended in Canada. A solution is to give a vitamin D bolus by mouth.~     This has been shown to safely and effectively increase vitamin D levels in children. The~     investigators hypothesise that a vitamin D bolus given in clinic will sufficiently increase~     the blood level of vitamin D to prevent the expected winter decline in vitamin D, compared~     with placebo in preschool-aged children with asthma. This six-month pilot randomized~     controlled trial aims to: (1) show that a vitamin D bolus is superior to placebo in raising~     vitamin D levels; (2) record the number of asthma attacks and viral infections in enrolled~     participants; and (3) identify problems that may call for protocol changes.~   "
119767|NCT01999894|"~     The purpose of this study is to evaluate the long-term safety and tolerability of memantine~     in the treatment of autism in pediatric patients.~   "
119768|NCT01999881|"~     This randomized pilot clinical trial studies exercise intervention in improving quality of~     life and exercise capacity and reducing inflammation and oxidative stress in patients with~     lung cancer and their support persons. Exercise therapy may help improve quality of life, may~     increase exercise capacity, and may reduce inflammation and oxidative stress in patients with~     lung cancer and their supporters.~   "
119769|NCT01999868|"~     The purpose of this study is to determine if the use of ustekinumab, followed by abatacept,~     will prevent relapse in people with moderate to severe plaque psoriasis.~   "
119770|NCT01999855|"~     For many years, it is known that asthmatics have more often dysphonia. However, no study has~     so far analyzed the reality of dysphonia in asthmatic by making phoniatric tests.~      The etiology of dysphonia in asthmatic remains controversial. Indeed, for a long time,~     inhaled corticosteroids have been considered as responsible for organic abnormalities of the~     vocal cords. We hypothesized that women with asthma have more often dysphonia, and that~     dysphonia is rather functional origin.~   "
119771|NCT01999842|"~     The purpose of this study is to evaluate the safety and immunogenicity of different~     formulations of GSK Biologicals' H7N9 influenza vaccine in subjects 18 to 64 years of age.~   "
119772|NCT01999829|"~     Atrial fibrillation remains a major cause of morbidity following cardiac surgery with~     cardiopulmonary bypass. Many mechanisms have been implicated. Among then, adenosine, a strong~     endogenous vasodilating agent has been involved in cardiac surgery-induced atrial~     fibrillation, via A2A receptors modulation.~      The effects of caffeine on the inducibility of atrial fibrillation are actually well-known,~     leading then to a significant reduction of atrial fibrillation. Moreover, a recent clinical~     study has demonstrated that coffee drinking was inversely associated with total and~     cause-specific mortality.~      The investigators therefore examined the preventive effects of oral caffeine on valvular~     surgery with cardiopulmonary bypass-induced atrial fibrillation. The investigators also~     evaluated prospectively the influence of caffeine on adenosine plasma levels and A2A~     adenosine receptors modulation.~   "
119773|NCT01999816|"~     The purpose of this study is to conduct a randomized controlled trial of a lifestyle redesign~     intervention's ability to (1)reduce the incidence of medically serious pressure ulcers and~     associated surgeries in adults with spinal cord injury, and (2)assess the intervention's~     cost-effectiveness and potential cost savings and its effects on participants' quality of~     life.~   "
119774|NCT01999803|"~     This is a phase I, multicentre randomised, double-blind, placebo-controlled trial to assess~     the safety and tolerability of continuous i.c.v. administration of sNN0029 infusion solution~     at a dose of 4µg/day in patients with Amyotrophic Lateral Sclerosis (ALS).~   "
119775|NCT01999790|"~     Grave's ophthalmopathy is the most common cause of orbital disease in adults. The clinical~     presentation may vary between sub clinic symptoms to severe ones. The eyelid retraction is~     one of the most important signs of Grave's ophthalmopathy and can lead to cosmetic and~     functional problems.~      The eyelid retraction can be found in the inflammatory stage and in the chronic disease, when~     it is stable. It can be described when the upper lid is contouring the superior limbus or~     positioned above that. This condition can lead to dry eye symptoms, exposure keratitis and~     cosmetic issues. The treatment can may be surgical or medical.~      The medical treatment are usually based on controlling thyroid function and in the use of~     steroids, both are not specific for the lid retraction, but for the inflammation that is~     common in the disease.~      In the longstanding disease, surgery is the most efficient treatment. There are several~     described techniques, they are based on the concept of weakening the muscles that act on lid~     elevation (levator and Muller Muscle).~      Basically the techniques can be divided in two groups: the first with an anterior approach~     (with skin scar in the lid sulcus) and the second using a posterior approach (through the~     conjunctiva).~      In the literature there is no consensus in deciding the best technique, regarding cosmetic~     results, incidence of complications, hypo or hypercorrection.~      In this trial we propose to compare two distinct techniques that are already in clinical use.~     The blepharotomy uses a cutaneous approach and the other a conjunctival approach.~      The patients will be divided in two randomized groups and surgical expected outcomes,~     cosmetics outcomes and complications occurrence will be compared.~   "
119776|NCT01999777|"~     This study is designed to evaluate the efficacy, safety, and tolerability of USL261 compared~     with that of intranasal (IN) placebo for the treatment of intermittent bouts of increased~     seizure activity.~   "
119777|NCT01999764|"~     This is a Phase IIa proof-of-concept study to evaluate the effects of oral QLT091001 on~     adults with impaired dark adaptation.~   "
119791|NCT01999582|"~     To determine the optimal route of administration, dose level, and safety of intravenous and~     subcutaneous dosing of sotatercept for maintaining hemoglobin levels in subjects who are on~     hemodialysis.~   "
119886|NCT01998321|"~     the Purpose of this study was to evaluate the short term outcome of patient specific~     instrument (PSI) in cases of bilateral simultaneous total knee arthroplasty (TKA) for knee~     osteoarthritis with sever varus~   "
119778|NCT01999751|"~     This study is a prospective, non-randomized, unblinded case series of patients with permanent~     pacemakers and implantable cardioverter-defibrillators undergoing medically-required magnetic~     resonance imaging (MRI) scanning, at St. Mary's Medical Center, Essentia Health. Patients~     will be enrolled over a 60-month period and followed for 12 months, with data collected to~     evaluate the study's primary endpoint, change in pacing thresholds over time, as well as a~     series of secondary endpoints, including: adverse events, symptoms, need to make pacemaker~     programming changes, and possible artifacts created by the pacemaker systems on the MRI~     scans. This study will allow for carefully monitoring of the safety MRI scanning in this~     population and improve practice models and protocols in the future.~   "
119779|NCT01999738|"~     Phase 1A/B, multicenter, open-label, non-randomized, dose-escalation oncology study to~     evaluate the administration of EC1456 in advanced solid tumors. In part A, EC1456 will be~     dose escalated on 4 concurrently enrolling schedules. FR-positive expression on a~     99mTc-etarfolatide scan is not required for inclusion in Part A.~      Part B of the study will confirm the maximum tolerated dose (MTD) and the recommended Phase 2~     (RP2) dose of EC1456, and evaluate the efficacy of EC1456 in NSCLC all subtype patient~     populations with FR-positive cancer in up to three schedules (i.e., twice weekly, once~     weekly, and four times weekly). FR-positive expression on a 99mTc-etarfolatide scan is~     required for inclusion in Part B.~      Minimum length of patient participation is anticipated to be 10 weeks (two 3-week cycles~     followed by a 30 day follow-up period).~   "
119780|NCT01999725|"~     The primary objective of the study is to determine the safety of single doses of orally~     administered EDP-788.~      Secondary objectives of the study are:~        -  To describe the pharmacokinetics of EDP-788 (and its metabolite EDP-322) after single~          doses of orally administered drug~        -  To estimate the bioavailability of EDP-788 capsules relative to an oral liquid~          suspension~        -  To estimate the effect of co-administration of food on the absorption of EDP-788~   "
119781|NCT01999712|"~     The left ventricular assist device (LVAD) is a portable mechanical pump that helps the left~     side of the heart of patients with severe heart failure that are awaiting heart~     transplantation or are not transplant candidates. However, while LVAD supports the left side~     of the heart, the right side must work on its own. Sometimes the right side does not recover,~     a condition called right ventricular failure (RVF). This complication increases mortality,~     prolongs hospitalization, requires additional procedures, and increases costs. Several risk~     factors and scores have been proposed to identify patients at risk for RVF. However, these~     methods have proven inadequate; one out of three patients is still experiencing right~     ventricular failure after LVAD surgery.~      Echocardiography, an established noninvasive method to see the heart without radiation or~     risk, has a lot of potential to identify patients at risk for RVF. The questions we will tray~     to answer with this American Heart Association funded project are:~        1. Can echocardiography before scheduled LVAD surgery predict who is going to develop RVF~          and poor quality of life so we can better select patients for LVAD surgery?~        2. Can echocardiography before scheduled LVAD surgery tell us the course of right~          ventricular function after implantation so we can potentially take additional measures~          and prevent RVF?~      To answer these questions, we will record images of the heart with echocardiography before~     LVAD surgery in 120 LVAD recipients at Emory University. We will then follow the patients for~     90 days to detect any symptoms and signs of clinical RVF and poor quality of life and record~     the course of right ventricular function with echocardiography.~      Currently, it is estimated that 150,000 to 250,000 patients in US are potential LVAD~     recipients with 2,000 devices implanted in 2012. LVAD can improve survival and quality of~     life in suitable patients. However, implantation requires a major surgical procedure with~     associated risks and considerable resources. Thus, careful patient selection is necessary to~     minimize risk for patients and maximize benefit for patients and society. Our long-term goal~     is to use echocardiography as a tool to (1) optimally select patients for LVAD and offer~     alternatives to patients at increased risk for complications and (2) potentially, inform~     earlier LVAD implantation in patients with weakening right ventricular function.~   "
119782|NCT01999699|"~     This study will investigate the response of the immune system to a hepatitis B (HB) vaccine~     in healthy adults 50 to 70 years of age. This study is partially funded by the National~     Institute of Allergy and Infectious Diseases.~   "
119783|NCT01999686|"~     This is a 3-arm, randomized, double-blind, double-dummy, and controlled clinical study over 6~     months of treatment to evaluate the metabolic and clinical efficacy as well as the safety of~     DLBS3233 alone, metformin and combination of both, in improving metabolic and reproductive~     parameters.~   "
119784|NCT01999673|"~     The primary purpose of this research study is to see whether adding bavituximab (an~     investigational drug) to the standard chemotherapy drug docetaxel, will improve the results~     of the treatment for non-small-cell lung cancer.~   "
119785|NCT01999660|"~     A treatment with SpaceOAR™ hydrogel does reduce late toxicity Grad 2 and Grad 3 of radiation~     therapy in prostate cancer patients~   "
119786|NCT01999647|"~     This study was designed to assess whether the injection of local anesthetic into the nerve~     (intraneural), as opposed to around it (perineural), requires a shorter time to develop~     surgical anesthesia of the lower leg.~      The investigators will compare the two types of injection using the same drug, so as to~     determine if there is an actual difference onset time. They will also examine the overall~     success rate of either kind of sciatic nerve blocks as the sole anesthetic for non-emergent~     orthopedic surgery.~      The safety of these procedures will be examined by in-hospital and phone-call follow-up~     contacts.~   "
119787|NCT01999634|"~     The aim of this study is to monitor by microdialysis the postoperative outcomes in order to~     identify anastomotic leaks after rectal surgery.~   "
119788|NCT01999621|"~     Investigators will evaluate determinants of the patients' care type : palliative, medical or~     intensive care. The place of patient or family on care's decision will be noticed.~     Investigators will evaluate 3 month-survival and patients' feelings (visit with a~     psychologist) according to type of care they benefited.~   "
119789|NCT01999608|"~     The role of vitamin D deficiency in female reproduction remains controversial. Early~     retrospective studies were inconsistent regarding the effect of serum 25-OH vitamin D levels~     on pregnancy rates in women undergoing in vitro fertilization (IVF), whereas two~     retrospective studies postulated that vitamin D deficiency may negatively affect pregnancy~     rates with an effect mediated through the endometrium.~      Taking into account that knock-out experiments have shown that vitamin D receptor null mice~     not only experience uterine hypoplasia but also impaired folliculogenesis, it might be~     hypothesized that vitamin D deficiency may have a detrimental effect on female ovarian~     reserve. This may be further supported by previous reports demonstrating that serum 25-OH~     Vitamin D levels correlates with antimullerian hormone (AMH) levels in women of advanced~     reproductive age.~      The aim of this study is to examine through a large set of prospectively recruited infertile~     women whether serum 25-OH-Vitamin D levels is related with the 2 most widely accepted~     biomarkers of ovarian reserve: serum AMH levels and antral follicle count (AFC).~   "
119790|NCT01999595|"~     The purpose of this study is to determine the antalgic of surface electrical stimulation with~     pulse frequencies and pad sizes on blunting pressure pain on healthy human due to various~     temporal and spatial summations of the stimulation.~   "
119798|NCT01999478|"~     The study is testing a new, safe and effective way for the early detection of colon cancer.~     The method uses Low-coherence Enhanced Backscattering Spectroscopy (LEBS). This is an optic~     probe which is a small device that uses light (not laser) to assess the colon lining. This~     probe will be used before colonoscopy to identify subjects who do and do not have~     precancerous changes in the colon by capturing the light reflected back from the rectal wall~     and that will be assessed without the need for colonoscopy and bowel preparation (colon~     cleaning). This device may detect early cancerous changes in colon tissue with higher~     accuracy than current tests.~   "
119799|NCT01999465|"~     Neonatal Brachial Plexus Palsy (NBPP), characterized by weakness and sensory loss in the~     affected arm, results from damage in the prenatal period to the nerves extending from the~     spine to the arm. Proper stretching and exercise of the joints and affected arm from the time~     of diagnosis can greatly assist in the development of healthy movement of the limb.~     Additionally, neuromuscular electrical stimulation has been shown to be an effective~     treatment in other neural disorders and therefore its effectiveness in NBPP is worth~     studying.~      In the case of NBPP patients, the loss in normal arm function can be observed very early.~     Young patients will often neglect using the affected arm or modify motions to avoid the use~     of the biceps muscle, specifically in hand to mouth actions such as gripping a bottle or~     placing toys or other objects in the mouth. A goal of this study is to test the effectiveness~     of NMES on the biceps muscle in improving the participant's ability to perform normal hand to~     mouth actions. Additionally, biceps muscle Medical Research Council (MRC) strength and active~     range of motion (AROM) will be tested to examine the increase of useful arm movement.~      The subjects of this study are newborns between the ages of 3-6 months who are already a part~     of the University of Michigan Brachial Plexus program. Parents of the children will be~     trained to perform the neuromuscular electrical stimulation therapy at home using the EMPI~     Continuum unit for 30 minutes each day and monthly follow up appointments will be performed~     be the research occupational therapists throughout three month study period.~      Parents of the participants will complete a questionnaire before and during the study period~     to help analyze for confounders and gather data regarding parent compliance and NMES~     effectiveness. To detect the effectiveness of NMES, two cohort groups using standard units~     and sham units will be recruited and compare with data analysis.~      The investigators predict that the NMES will effectively improve the ability of the neonate~     to increase use of the affected arm, specifically in hand to mouth movements and other~     aspects of biceps MRC score and AROM.~   "
119800|NCT01999452|"~     Background Paleolithic diet is a modern dietary regimen based on food eaten during the~     Paleolithic (2.5 million-10.000 years before present); lean meats, fish, shellfish, fruits,~     vegetables, root vegetables, eggs and nuts. Food that was not eaten during the Paleolithic is~     avoided; cereals, dairy products, salt, refined sugar and fat. The rationale for Paleolithic~     diet is based on the lack of type 2 diabetes and associated diseases among hunter-gatherer~     populations. Our group have previously studied effects of Paleolithic diet in an~     observational study in humans, an intervention study in animals and two intervention studies~     in patients with type 2 diabetes or lowered glucose tolerance and ischaemic heart disease.~     Our intervention studies showed significant improvement of glucose tolerance, HbA1c, blood~     lipids, blood pressure, weight, waist circumference and satiety on Paleolithic diet compared~     with a Mediterranean-type diet and diabetes diet. Studies by other research groups on healthy~     individuals found that Paleolithic diet lowered weight, waist circumference, blood pressure,~     PAI-1, blood lipids and ectopic lipid deposition, and also improved glucose tolerance and~     insulin sensitivity.~      Purpose and aims Our goal is to study effects of Paleolithic diet compared to recommended~     diet on risk factors, morbidity and mortality from type 2 diabetes and associated diseases in~     a sufficiently large and well executed study to be included in basis for future dietary~     recommendations.~      Project descriptions SwePaD is a study with an initial 18 month long randomized cross-over~     dietary intervention on 150 patients with type 2 diabetes where the whole study population~     upon finishing the initial dietary intervention is studied as a cohort for another 5 years.~     The initial 18 month long dietary intervention compares 6 months on Paleolithic diet with 6~     months on recommended diabetes diet separated by 6 months wash-out period. After the initial~     18 month long dietary intervention the study participants are recommended to follow~     recommended diabetes diet with implementation of optional elements from a Paleolithic diet~     for the remaining 5 years of the study.~      The intervention, in the form of diet information, will be given orally and written by the~     study participant's own diabetes nurse or doctor, based on similarly designed written~     information on the two diets. The same intervention was successfully used in our pilot study.~     The study participants will otherwise receive usual treatment.~      Power calculations show that 126 participants are needed to obtain significant results with~     80% power at the 95% significance level for the primary outcome HbA1c. The pilot study with~     the same intervention but slightly healthier participants than the average patient in~     Diabetesregistret showed significant results on HbA1C with only 13 participants.~      Secondary outcomes are fasting glucose levels, weight, waist circumference, blood pressure,~     blood lipids, urinary albumin, diabetes retinopathy, smoking, physical activity,~     monofilaments (detection of peripheral neuropathy) and health related quality of life~     assessed by the health survey questionnaire SF-36. Primary and secondary outcomes as well as~     medication will be registered before and after each intervention diet. Data on primary and~     secondary outcomes, morbidity and mortality from type 2 diabetes and associated diseases will~     be retrieved for up to five years after participants' completion of the dietary intervention~     from the Diabetes register, Cause of Death Register (Dödsorsaksregistret) and the Hospital~     Discharge Register (Patientregistret) and compared to expected outcome from a statistical~     model based on the Diabetes register (A new model for 5-year risk of cardiovascular disease~     Cederholm et al 2011) and/or a matched control group from the Diabetes register.~      Participants will be recruited nationwide through information to health care personnel in~     primary health care and hospital diabetes clinics and to patient organisations. Participants'~     registration, intervention and data gathering will be administered by the participants' own~     diabetes nurse or doctor via REDCap, a web based tool for secure electronic data capture~     hosted on secure servers with daily back-up by the Library and IKT department of the medical~     faculty at Lund University.~      Dietary evaluation will be made using four day weighed food records on paperforms before and~     after each intervention diet and 6 months after the last intervention.~   "
119801|NCT01999439|"~     To evaluate quantitative magnetic resonance imaging(MRI) as a potential non-invasive,~     radiation-free diagnostic tool for evaluating esophageal wall remodeling (thickness and~     stiffness) and response to treatment in children and adolescents with newly diagnosed~     eosinophilic esophagitis (EoE) presenting with dysphagia (difficulty swallowing) and food~     impaction.~   "
119802|NCT01999426|"~     Emergency on-call respiratory physiotherapy cover for children in intensive care is~     frequently provided by physiotherapists who ordinarily work in non-respiratory areas. This~     has produced concerns about the safety and efficacy of on-call treatments and is widely~     recognised as an important clinical governance issue affecting services throughout the~     National Health Service (NHS).~      The aim of this study is to investigate whether emergency on-call respiratory physiotherapy~     services provided in the paediatric intensive care unit (ICU) are safe and effective. Further~     it will explore whether there are any quantifiable differences between specialist and on-call~     physiotherapy treatments.~      The study is a randomised, cross-over study design. Infants and children who are likely to~     require at least 2 physiotherapy treatments in one day are recruited to the study. Both~     physiotherapy airway clearance treatments are administered during a 12 hour period, with at~     least 2 hours between treatments. One is administered by a respiratory physiotherapist who~     works regularly in the ICU and one by a physiotherapist on the on-call rota, who normally~     practises in a non-respiratory clinical area. Treatments are performed in a randomised order~     and outcomes measured before, during and after treatments.~      Physiotherapy staff who consent to participate in the study include:~      Specialist respiratory physiotherapists who regularly work in the ICU Non-respiratory~     physiotherapists on the on-call rota who normally work in a non-respiratory areas but cover~     the ICU overnight and at weekends.~      Patients include:~      the study aims to recruit 80 infants and children (ages 0 to 16 years), who are in the~     paediatric intensive care unit and~        1. Require full mechanical ventilation and are well sedated~        2. Are likely to require at least two physiotherapy treatments within the day of the study~          (assessed by an independent senior respiratory physiotherapist) and~        3. Whose parents or carers consent for them to participate in the study. Respiratory~          mechanics, arterial blood gases, oxygen saturation and peak pressures are recorded~          before and after each intervention Forces applied during manual techniques, flow,~          pressure and volume during manual lung inflations, volume of saline and selection and~          order of treatment components are recorded during treatments Adverse events occurring~          during or up to 30 minutes after physiotherapy are also recorded.~   "
119803|NCT01999413|"~     Pilot study of the efficacy and tolerance of the adjunction of a Fish oil emulsion to~     daunorubicin and cytarabine chemotherapy for the treatment of Acute MYeloblastic Leukemia of~     Younger patients (under 61 years) with high-risk cytogenetics.~   "
119804|NCT01999400|"~     This study is designed to provide data to the FDA correlating pharmacokinetics with local~     availability of medications within the gastrointestinal tract. This study will support the~     establishment of scientifically based standards for evaluating drugs which act locally within~     the gastrointestinal tract. Specific objectives of this study are to: (1) quantify how the~     plasma concentrations of mesalamine, an agent used to treat inflammatory bowel disease, are~     correlated with the concentrations in gastrointestinal fluids; and (2) improve the~     physiologically based models for drug absorption from the intestine. Information from this~     study in concert with in vitro dissolution data will be used to evaluate in vivo-in vitro~     correlation (IVIVC) for concentrations in plasma and intestinal lumen and dissolution of~     mesalamine products.~   "
119805|NCT01999387|"~     Food allergy is a potentially life threatening condition. The current practice consists of~     elimination diet and injectable epinephrine in case of a reaction.~      Recently, oral immunotherapy has emerged as a treatment for food allergy in milk eggs and~     peanuts.~      We conduct an oral immunotherapy program with ~500 patients so far. In this study we intent~     to follow patients who completed the program and assess their allergy status and quality of~     life.~   "
119806|NCT01999374|"~     Since its inception, the Diabetes Research Institute (DRI) has made significant contributions~     to the field of diabetes, pioneering many of the techniques used in diabetes centers around~     the world. Through several clinical trials, DRI has demonstrated that diabetes can be~     successfully reversed as a result of islet cell transplant.~      Over the years the following protocols in islet cell transplantation have been initiated:~     2000/0329; 2000/0196; 2004/0205; 2000/024; 2006/0200; 2006/0508; 2006/0210.~      All of the studies listed above will be source of study subjects for this study.~     Approximately 30 subjects are expected to be enrolled and followed in this trial.~      After islet-cell transplantation in the parent studies, each subject receives maintenance~     immunosuppressive medications.~      The purpose of this protocol is to collect additional follow-up for safety and efficacy from~     subjects with graft function after their completion in their parent study. It is expected~     that most subjects will retain measurable islet function and, in the islet-alone studies,~     continue to receive immunosuppressive medications at the time of completing their parent~     study.~   "
119807|NCT01999361|"~     This is a single-center, prospective, open label study in islet transplant recipients after~     complete islet graft rejection/loss, defined as stimulated c-peptide ≤0.3 ng/mL.~   "
119808|NCT01999348|"~     The study will evaluate patients diagnosed with POAG or OHT who are switched to GANFORT® UD~     (unit dose of fixed combination bimatoprost and timolol) therapy for medical reasons in~     accordance with physician standard clinical practice. All treatment decisions lie with the~     physician.~   "
119809|NCT01999335|"~     The purpose of Phase 1 of the study is to determine the maximum tolerated dose and assess the~     safety, tolerability and activity of oprozomib in combination with pomalidomide and~     dexamethasone in subjects with primary refractory or relapsed and refractory multiple~     myeloma.~      The purpose of Phase 3 of the study is to compare the key outcome measures for subjects with~     primary refractory or relapsed and refractory multiple myeloma who are randomized to either~     oprozomib or placebo in combination with pomalidomide and dexamethasone.~   "
119810|NCT01999322|"~     This trial is conducted in Europe and the United States of America (USA). The aim of this~     trial is to evaluate compatibility and safety of FIAsp (faster-acting insulin aspart) and~     insulin aspart (NovoRapid®) with an external continuous subcutaneous insulin infusion (CSII)~     system in adult subjects with type 1 diabetes.~   "
119811|NCT01999309|"~     Rationale: There is ample evidence that inflammatory processes play a role in the~     pathophysiology of schizophrenia. Although Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)~     have been shown to be able to reduce symptoms in these patients, these drugs either have~     unfavourable cardiovascular side effects or are otherwise not well tolerated. Moreover,~     patients with schizophrenia already tend to have an increased cardiovascular risk. The~     combination of well-established vascular protection and reduction of inflammation by~     simvastatin offers a highly attractive potential to further improve the treatment of~     schizophrenia and related disorders.~      Hypotheses: Daily treatment with 40mg simvastatin in addition to antipsychotic treatment~     reduces psychotic symptoms, improves cognition, attenuates brain volume loss, and decreases~     the risk for metabolic syndrome as well as for movement disorders, when compared to placebo.~      Objective: The primary objective of this trial is to investigate the proposed beneficial~     effect of simvastatin as compared to placebo when given for one year in addition to~     antipsychotic medication to patients with psychotic disorder. We expect lower symptom~     severity as measured with the PANSS (Positive and Negative Syndrome Scale) and less cognitive~     decline as measured with the BACS (Brief Assessment of Cognition in Schizophrenia).Secondary~     objectives are assessment of general functioning, presence and severity of metabolic syndrome~     and degree of movement disorders, and assessments of brain volume. Lastly, we examine various~     immunological parameters in serum and peripheral blood mononuclear cells and the experience~     of childhood trauma.~      Study design: Randomized placebo-controlled double-blind trial.~      Study population: 150 men and women, between 18 and 50 years of age, diagnosed with~     schizophrenia, schizoaffective or schizophreniform disorder (DSM-IV 295.*) or psychosis NOS~     (not otherwise specified) (298.9). Onset of first psychosis no longer than 3 years ago.~      Intervention: Patients will be randomized 1:1 to either 40 mg simvastatin or placebo daily,~     in the form of identical tablets.~   "
119812|NCT01999296|"~     All patients undergoing laparoscopic visceral and gynecologic procedures using the combined~     bipolar and ultrasonic vessel sealing and dissection device Thunderbeat are entered in a~     prospective registry. Data will be analysed concerning the safe use of the instrument and~     perioperative blood loss.~   "
119813|NCT01999283|"~     Exercise has been found to be effective in alleviating back and neck pain. Two exercise~     methods which are available in the community in a group format are Yoga and Pilates. While~     there is some research on the efficacy of these exercise methods for low back pain, there is~     no definitive research on the use of Yoga or Pilates group exercise for individuals with~     chronic cervical pain.This study investigated the effect of group Yoga and Pilates exercise~     compared to a wait-listed control group on impairments and function related to neck pain for~     individuals with chronic cervical pain.~   "
119814|NCT01999270|"~     To determine if FDOPA-PET/MRI imaging can predict response to treatment of bevacizumab.~   "
119815|NCT01999257|"~     The investigators have developed a new website to educate persons of Ashkenazi Jewish~     ancestry about their increased risk for having children with certain genetic conditions, and~     the genetic testing the investigators offer. This study aims to pilot the website to find out~     whether it is effective and to learn what the investigators can improve.~      Participants in the study will be assigned to one of two conditions:~        1. Standard in-person genetic counselling session to learn about inheritance of Ashkenazi~          Jewish genetic conditions and genetic testing. Participants will fill out two short~          questionnaires, one before and one after the genetic counselling session. They will then~          be given a requisition form to undergo blood draw for genetic testing at the Montreal~          General Hospital test centre.~        2. Use of a web-based pre-test genetic counselling tool to learn about inheritance of~          Ashkenazi Jewish genetic conditions and genetic testing. They will fill out two short~          questionnaires, one before, and one after using the web-based tool. They will then be~          electronically sent a requisition form to undergo blood draw for genetic testing at the~          Montreal General Hospital test centre.~      In both conditions, genetic test results will be communicated by telephone once they are~     available. Participants' genetic test results will not be used in any way for the study.~   "
119816|NCT01999244|"~     Despite continued research on effective interventions, obesity remains a major public health~     issue in the United States. Current treatments, including behavioral weight management~     programs, weight loss surgery, and pharmacotherapy, tend to be high in cost and have limited~     reach, reducing the ability of these treatments to address the population-wide scope of the~     obesity epidemic. Recent advances in technology that improve the ease of self-monitoring and~     provide targeted feedback offer promise to help larger groups of individuals to lose weight.~     Despite the commercial popularity of these products, however, little research has been~     conducted to evaluate their impact on excess body weight or to determine how they should~     ideally be implemented. Two key questions need to be addressed. First, is use of~     self-monitoring technology sufficient to produce weight loss, or must this technology be~     combined with interventionist contact? Second, how cost-effective is a technology-based~     intervention, with and without interventionist contact? The current study is small~     prospective, randomized pilot study comparing a self-guided self-monitoring condition (SC) to~     a technology only condition (TECH) and a technology plus interventionist support condition~     (TECH+INT). All participants will all be given basic weight management information knowledge~     and randomized to one of three conditions. Participants in the self-guided self-monitoring~     condition (SC) will receive traditional paper self-monitoring logs, a standard body weight~     scale, and a pedometer and calorie book; participants in the technology-based condition~     (TECH) will receive an electronic activity monitor and WiFi-enabled body weight scale, and~     will track caloric intake via an associated website; and participants in the interventionist~     contact condition (TECH+INT) will receive the same technology as in the TECH condition,~     combined with weekly interventionist contact delivered via telephone. We will compare the~     impact of each condition on weight loss and investigate preliminary cost-effectiveness.~   "
119817|NCT01999231|"~     In the tests, small sample of clinical study about Recombinant Mycobacterium Tuberculosis~     Allergen ESAT6-CFP10 ( Recombination EC Allergen） healthy adults was carried out.~      24 healthy adults were included as study objects, they were randomly divided into four groups~     of different Recombinant Allergen EC dose (1, 5, 10μg/mL, maximum tolerated dose 20μg/mL, 6~     person/dose) for single arm intradermal injection.~      The main examination items :vital signs (breathing, heart rate, blood pressure, body~     temperature ) of each volunteer at 15min, 30min, 1h, 2h, 4h, 8h, 24h, 48h, 72h, 96h after~     injection, skin reactivity (redness and/or induration) diameter of injection sites,local~     reaction ( rash, pain, itching, and skin and mucous membranes ) ,a variety of adverse~     events,routine blood,routine urine, liver and kidney function, ECG and chest X-ray films~     before and 7 days after intradermal injection .~      Preliminary evaluation of safety and tolerability of Recombinant Allergen EC applied in~     humans, which can provide a safe dosage range for phase II clinical study.~   "
119818|NCT01999218|"~     This study will evaluate the efficacy and safety of the addition of ertugliflozin~     (MK-8835/PF-04971729) compared with the addition of glimepiride in participants with T2DM who~     have inadequate glycemic control on metformin. The primary hypothesis of this study is that~     after 52 weeks, the change from baseline in hemoglobin A1c (A1C) in participants treated with~     the addition of ertugliflozin 15 mg once daily is non-inferior compared with that in~     participants treated with the addition of glimepiride.~   "
119819|NCT01999205|"~     The participants are twelve small or middle-sized companies. Baseline information about the~     company's practices and employees' physical activity is collected in November 2013 with~     questionnaires and accelerometers. A team is nominated in each company to develop company's~     practices in relation to promoting physical activity and reducing sedentary behavior among~     employees. The teams are supported with materials and meetings and the opportunity to obtain~     physical activity services from the regional offices of the Finnish Sports Confederation. The~     development process is carried out in Fall 2013 and the actions to promote physical activity~     and to reduce sedentary behavior are implemented in the companies during spring and fall~     2014. The follow-up evaluation with the same measures as at baseline will be conducted in~     November 2014 and depending on financing possibly also in November to assess the maintenance~     of the actions.~   "
119820|NCT01999192|"~     The purpose of this study is to determine the efficacy and safety of three different~     Tregalizumab doses in combination with Methotrexate (MTX) in subjects who have active~     rheumatoid arthritis and an inadequate response to MTX alone.~      The overall study duration is 24 weeks followed by a 24 week extension phase.~   "
119821|NCT01999179|"~     The goal of the pilot study is to determine if a multicenter prospective cohort study of~     cancer patients with blood clots associated with catheters is feasible. Cancer patients with~     catheter-related thrombosis treated with one month of anticoagulation will be evaluated for~     for post-thrombotic syndrome. Laboratory biomarkers will be evaluated as predictors of~     recurrent thrombosis.~   "
119822|NCT01999166|"~     This study will investigate the genes responsible for osteoarthritis. Individuals with~     osteoarthritis known or suspected to be caused by a gene mutation (change) may be eligible~     for this study. Family members may also participate.~      Patients will talk with investigators who will explain the study and its possible~     implications for the patient and family and answer questions. The patient's medical records~     will be reviewed, a personal and family history will be taken, and a physical examination~     will be done. Two procedures may be done including blood sampling (which will be used for DNA~     (genetic) studies) and X-rays (to define osteoarthritis grade).~      If no known mutations responsible for osteoarthritis will be detected, participating family~     members will be interviewed by telephone about their personal and family health history and~     will have a blood sample drawn for DNA testing, and X-rays.~   "
119823|NCT01999153|"~     The aim of the study is to Evaluate of the analgesic effect of ropivacaine in topical use at~     the thin skin graft donor site.~      For Patient needing a thin skin graft < 320 cm2, randomization will be done in 2 groups, one~     receiving the standard treatment (20 mL of physiologic serum) during the surgical~     intervention in topical use to recover an alginate dressing (Algosteril)and the other receive~     20 mL of Naropein during the surgical intervention on alginate dressing.~      The hypothesis of the study is the administration of ropivacaine will decrease the~     post-operative pain compared to physiologic serum~   "
119824|NCT01999140|"~     The ICD Registry™ is a nationwide quality program that helps participating hospitals measure~     and improve care for patients receiving implantable cardioverter defibrillators (ICDs) and~     cardiac resynchronization therapy devices with defibrillator (CRT-Ds). The ICD Registry~     captures the characteristics, treatments, and outcomes of patients receiving (ICDs).~     Patient-level data is submitted by participating hospitals on a quarterly basis to the~     American College of Cardiology Foundation's (ACCF) National Cardiovascular Data Registry~     (NCDR) which then produces an Outcomes Report of the hospital's data, with comparison to both~     a volume peer group (number of ICD patients submitted annually) and the entire ICD registry~     data set.~   "
119825|NCT01999114|"~     The purpose of this study is to evaluate the ECG effects of 10, 40, and 80 mcg/hr~     buprenorphine delivered by BTDS alone, or by BTDS dosed with naltrexone, relative to placebo~     in healthy male and female subjects.~   "
119826|NCT01999101|"~     The primary aim of the study is to evaluate the safety and tolerability of Px-104 in NAFLD~     patients and to assess the influence of Px-104 on hepatic fat.~   "
119827|NCT01999088|"~     Volunteers were randomly assigned by gender to follow of two 12 weeks experimental periods:~     intervention (I) and control (C) in different order (I/C or C/I). Both periods were separated~     by a 4 weeks wash-out interval during which subjects returned to their usual diet:~      During the I period, volunteers weekly consumed three 150g/serving Functional Meat (FM)~     products (cooked Ham and Turkey breast). It was firmly recommended that all other meats and~     meat derivatives had to be excluded from the diet.~      During the C period, volunteers consumed identical amounts of meat products that did not~     include functional ingredients (Control Meat (CM)).~      Functional meat (FM) products (Functional cooked Ham (FH) and Functional cooked Turkey breast~     (FT)), were manufactured mixing the meats with the patented formula® (P200402755.2004). The~     amount of supercritical rosemary extract, deodorized salmon oil and vitamin E used was~     respectively, 0.02% w/w, 0.6% w/w, and 0.001% w/w.~      Control meat (CM) products (Control cooked Ham (CH) and Control cooked Turkey (CT), were~     prepared without addition of the functional ingredients.~   "
119828|NCT01999075|"~     Duchenne Muscular Dystrophy is complicated by weak breathing muscles and lung infections.~     Lung volume recruitment is a technique performed using a face mask or mouthpiece and a~     hand-held resuscitation bag to stack breaths, inflate the lungs and help clear the airways of~     secretions by increasing the forcefulness of a cough. We believe this will slow down the~     steady loss of lung function, prevent lung infection, and improve quality of life. Our aim is~     to compare the outcome of a group of individuals with DMD treated with standard care to~     another group that also receives lung volume recruitment. If effective, this study will~     change clinical practice by including twice-daily treatment as part of the standard of care~     for individuals with DMD, in order to improve their lung health and quality of life.~   "
121307|NCT01979666|"~     The pathogenesis of AVN includes a defective blood supply to the knee joint. Local nitrates~     induce peripheral vasodilation and may improve blood supply to the affected tissue.~      This study aims to test whether the use of a nicotine patch may accelerate the healing~     process from AVN of the knee.~   "
119829|NCT01999062|"~     In the proposed research study, we are investigating the feasibility of integrating automated~     planning tools to MR images acquired using a novel MR-guided linac, for on-line adaptive~     radiation treatment. However, these on-line automation tools require further technical~     refinement and clinical validation. The goal of this research proposal is to develop an~     on-line MR-guided radiation therapy process for adapting breast IMRT treatment. Such an~     approach will provide early stage breast cancer patients timely access to high-quality~     adaptive treatments without exposure to additional ionizing radiation.~   "
119830|NCT01999049|"~     The Argus II Retinal Implant is a revolutionary new device, which offers vision to patients~     who are blind from retinal degeneration - retinitis pigmentosa. These patients have no~     alternatives. Patients typically can achieve ambulatory vision.~   "
119831|NCT01999036|"~     Evaluation of the impact of bystander CPR, prehospital resuscitation protocols, and hospital~     post-resuscitation protocols for out-of-hospital cardiac arrest patients in the state of~     Arizona.~   "
119832|NCT01999023|"~     Chronic renal disease is now the tenth leading cause of mortality Taiwan. It is worth to~     study the effect of low protein formula on the retardation of failing renal function,~     decrease plasma homocysteine and oxidative stress and further increase antioxidant capacities~     in patients with chronic kidney disease. The purpose of this study is going to investigate~     the effects of protein formula on renal function, homocysteine , oxidative stress and~     antioxidant capacities in patients with chronic kidney disease. One hundred and twenty~     patients with end stage renal disease (stage 2~4) who meet the inclusion criteria will be~     recruited from Taichung General Veterans Hospital, Taichung. Participant patients will be~     blinded and randomly assigned to either the placebo (n = 60) or low protein formula (n = 60)~     for 12 weeks. Data on demography, anthropometry and medical history will be collected, and~     fasting blood samples and 24 h urine samples will be obtained at week 0, 12 and 24 during~     intervention period. The levels of hematological, plasma and erythrocyte PLP, plasma~     pyridoxal and 4-pyridoxic acid, serum and erythrocyte folate, serum vitamin B-12,~     homocysteine, lipid peroxidation indicators, glutathione, total antioxidant capacity and~     antioxidant enzymatic will be measured. Twenty-four hour urine volume will be recorded and~     urine creatinine and urea nitrogen will be analyzed. Creatinine clearance rate will be~     measured. Hopefully, the results of this study could provide more pictures on beneficial~     effects of low protein formula on renal function, plasma homocysteine, oxidative stress and~     antioxidant capacities in patients with chronic kidney disease.~   "
119833|NCT01999010|"~     Mood journaling is a cornerstone of self-management in major depressive disorder (MDD).~     Research over the last decade has shown that electronic mood journals are superior to paper~     ones. One potential advantage of mental health telemetry (MHT), which use cell phones to~     collect mood journal data, is that electronic journal data can easily be converted into~     graphical records, allowing people living with MDD to readily spot trends, correlations, or~     patterns in ways that would be quite challenging using paper diaries. This information should~     make it easier to recognize and evaluate changes in mental health status -- the first two~     steps in the process of self-management. The investigators will develop and deploy a~     visualization module for patients with which to explore their own MHT data sets on the same~     cell phones which they record their journals, and test the investigators hypotheses that~     their enhanced MHT system will (i) improve patients' ability to self-manage MDD and (ii)~     enhance their quality-of-life.~      The study is a non-randomized, un-blinded, A-B-A' (modified single-subject withdrawal design,~     with user choice of treatment or withdrawal in the A' stage) study, to explore the utility of~     MHT as a tool for enhancing self-management and QoL for persons living with MDD. The aims of~     this study are to explore the impact of MHT on subjects' self-management and QoL, and to~     gauge participants' perceptions of MHT's utility.~   "
119834|NCT01998997|"~     To address the feasibility of implementing a randomized, educational intervention to prevent~     delirium, directed at family members of hospitalized older (70 years of age or older) medical~     in-patients. Specifically rates of recruitment and acceptance rates of such an intervention~     to family members will be assessed. An estimate of the effect size of this intervention will~     also be calculated. This is a pilot study. The investigators hypothesize that this~     intervention will be feasible and agreeable to family members to perform, with acceptance~     rates exceeding 80%.~   "
119835|NCT01998984|"~     This is a randomised, double-blind, parallel groups, vehicle controlled, 8-week phase 2~     trial. The objective is to evaluate efficacy of ingenol mebutate gel 0.06 % after once daily~     treatment for 2, 3 or 4 consecutive days compared to vehicle gel~   "
119836|NCT01998971|"~     The purpose of this study is to evaluate the safety, tolerability, and dose regimen of~     daratumumab when administered in combination with various treatment regimens for the~     treatment of multiple myeloma.~   "
119837|NCT01998958|"~     The purpose of this study is to assess the efficacy and dose response of intranasal~     esketamine (Panel A: 28 mg, 56 mg, and 84 mg and Panel B: 14 mg and 56 mg) compared with~     placebo in improving depressive symptoms in participants with treatment-resistant depression~     (TRD).~   "
119838|NCT01998945|"~     We will compare two programs that are designed to help older adults who have had fall~     injuries manage anxiety and improve their level of functioning. We expect that both programs~     will provide some benefit, but that one will promote better management.~   "
119839|NCT01998932|"~     Chronic venous ulceration of the lower limb poses a significant problem to patients and~     healthcare providers alike. 1% of the population of Western countries have either an open or~     healed chronic venous ulcer.~      However, the pathophysiological abnormalities are not entirely clear in how raised venous~     pressure translates into the changes seen in the skin culminating in an open ulcer. The~     standard treatment of this condition in the United Kingdom is to undertaken compression~     bandaging of the lower limb.~      In order to further their knowledge of venous ulceration, the investigators seek to determine~     the biological profile of venous ulcers over a maximum of twenty-eight weeks and by dividing~     the groups into healing and non-healing wounds, the investigators may be able to demonstrate~     a difference in the biological profile.~      This work may provide insights into predicting who will respond to treatment and targets for~     treatment in the future.~   "
120978|NCT01983969|"~     The goal of this clinical research study is to find the highest tolerable dose of azacitidine~     that can be given with vorinostat, gemcitabine, busulfan, and melphalan, with a stem cell~     transplant, and with or without rituximab. Researchers also want to learn about the safety~     and level of effectiveness of this combination.~   "
119840|NCT01998919|"~     This study will evaluate the efficacy and safety of sequential administration of Tarceva and~     gemcitabine/platinum chemotherapy in patients with stage IIIb/IV non-small cell lung cancer.~     Patients will be randomized to receive Tarceva (150 mg po) or placebo on days 15-28 of a 4~     week cycle of intravenous platinum-based chemotherapy, for a total of 6 cycles. The~     anticipated time on study treatment is until disease progression or unacceptable toxicity.~   "
119841|NCT01998906|"~     This study will assess the efficacy and safety of adding Herceptin to a paclitaxel-containing~     regimen followed by cyclophosphamide/methotrexate/fluorouracil (CMF) chemotherapy in women~     with locally advanced breast cancer and HER2/c-erbB-2 gene amplification. In a parallel~     observational study patients with HER2-negative disease will receive the same chemotherapy~     without Herceptin.~   "
119842|NCT01998893|"~     This study will evaluate the efficacy and safety of MabThera/Rituxan in patients with~     relapsed low-grade centroblastic centrocytic non-Hodgkin`s lymphoma. Patients will receive~     once-weekly intravenous MabThera/Rituxan for 4 weeks; responding patients will be treated a~     second time in case of relapse (defined as progression after complete or partial response).~     The anticipated time on study treatment is <3 months.~   "
119843|NCT01998880|"~     This open-label, randomized, 3-arm study will evaluate the efficacy and safety of~     obinutuzumab (RO5072759) in combination with chlorambucil as compared to rituximab plus~     chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic~     leukemia (CLL). Patients will be randomized 2:2:1 to receive a maximum of six 28-day cycles~     of either RO5072759 (1000mg iv infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles~     2-6) plus chlorambucil (0.5 mg/kg orally, days 1 and 15 of cycles 1-6), or rituximab (iv~     infusion day 1, 375 mg/m^2 cycle 1, 500 mg/m^2 cycles 2-6) plus chlorambucil, or chlorambucil~     alone. Anticipated time on study treatment is >6 months and follow-up for disease-progression~     and safety will be at least 5 years. In the US, this trial is sponsored/managed by Genentech.~   "
119844|NCT01998867|"~     1. To develop a database containing matched information from dynamic tests of postprandial~          glycemic control (OGTT or MMTT), results of a broad panel of fasting biomarkers, and~          clinical information related to diabetes risk obtain through subject interview.~        2. To use the database to identify fasting biomarkers and associated algorithms to best~          predict parameters derived from dynamic tests (OGTT or MMTT) such as Insulin Glucose~          Tolerance (IGT), impaired first phase insulin response, etc., controlling for clinical~          information such as current medication use.~   "
119845|NCT01998854|"~     Study is intended to evaluate the one-year safety and clinical status of patients treated for~     symptomatic uterine fibroids with the VizAblate Intrauterine-ultrasound guided radio~     frequency (RF) ablation system. Particular attention will be directed to recording safety~     outcomes including incidence of uterine cavity synechiae. In addition, information on quality~     of life will be collected.~      Overall study duration (first patient enrolled through last patient exit) will be comprised~     of approximately 12 months of patient enrollment up to 1 month for scheduling of treatment,~     and 12 months of follow-up, for a total duration of up to 25 months. Study duration for an~     individual patient, once enrolled, will be approximately 1 month for baseline observations~     and treatment scheduling, and 12 months for follow up after treatment for a total duration of~     approximately 13 months.~   "
119846|NCT01998841|"~     This randomized, double-blind, placebo-controlled, parallel group, adaptive study will~     evaluate the efficacy and safety of crenezumab versus placebo in individuals who carry the~     PSEN1 E280A autosomal-dominant mutation and do not meet the criteria for mild cognitive~     impairment due to AD or dementia due to AD and are, thus, in a preclinical phase of AD.~     Participants will be randomized in a 1:1 ratio to receive either crenezumab or placebo~     subcutaneously (every 2 weeks) or intravenously (every 4 weeks) for at least 260 weeks. The~     switch to the intravenous (IV) dose will be optional (as per participant decision). The study~     will also include a cohort of PSEN1 E280A mutation non-carriers who will be dosed with~     placebo only.~   "
119847|NCT01998828|"~     This open-label study is to determine the safety and efficacy of momelotinib in participants~     with either polycythemia vera (PV) or essential thrombocythemia (ET) who have not yet~     received treatment with a Janus kinase (JAK) inhibitor.~   "
119848|NCT01998815|"~     The purpose of this study is to examine how physical activity and lifestyle factors influence~     postoperative recovery and postoperative complications after bariatric surgery.~      The hypothesis is that physically active people, with a healthy alcohol consumption and non~     smokers have shorter lengths of hospital stay, shorter sick-leave, fewer re-hospitalizations~     and fewer re-operations, fewer complications as well as a faster recovery after a surgical~     procedure.~      The investigators also hypothesize that possible risk factors for non-surgical postoperative~     complications e g abdominal discomfort are also life-style related factors such as smoking,~     high alcohol consumption, low level of physical activity, as well as other risk factors such~     as prior frequent abdominal pains (e g irritable bowel syndrome symptoms), high levels of~     anxiety and/or depression, difficulties with coping with the changed food intake regimen~     after obesity surgery, and generally high sensitivity for painful-sensations and nausea.~      First aim of this study is to investigate how life style factors prior to obesity surgery are~     related to hospital stay, sick-leave, immediate postoperative complication rates and the rate~     of resumption of QoL and normal physical function.~      The second aim of the study is to identify risk factors for the development of chronic~     abdominal discomfort and dumping symptoms after obesity surgery.~   "
119849|NCT01998802|"~     This is a phase III double-masked, randomized, controlled study evaluating the efficacy of~     EBI-005 as compared to vehicle given as a topical ophthalmic solution in each eye to subjects~     with moderate to severe DED three times daily for 12 weeks. Approximately 730 subjects at up~     to approximately 50 centers in the United States will be screened, enrolled into the study.~   "
119850|NCT01998789|"~     The purpose of this study is to evaluate the efficacy of an everolimus conversion (EVR)~     protocol as compared to the standard tacrolimus (TAC) based protocol in liver transplant~     recipients, as determined by renal function, rejection rates, and progression to fibrosis (in~     HCV positive subjects). Additionally, safety profile and tolerability of these regimens will~     be assessed.~   "
121229|NCT01980680|"~     After hCG trigger a large amount of exogenous progesterone is used for luteal phase support~     in many countries until 10th week of gestation. Instead we suggest the use of two small doses~     of hCG after the trigger during the early luteal phase after GnRHa trigger, promoting the~     endogenous progesterone production from the corpora lutea (CL).~   "
119851|NCT01998776|"~     ASA is the most commonly drug used worldwide for prevention of cardiovascular diseases.~     However, ASA is increasingly recognized as a culprit for small bowel bleeding. Small bowel~     bleeding is notoriously difficult to diagnose because it is beyond the reach of conventional~     endoscopy. The advent of wireless, video capsule endoscopy has revolutionized the~     visualization of small bowel. Capsule endoscopy is a pill that contains a tiny camera for~     capturing pictures of the small bowel after being swallowed. Currently, capsule endoscopy is~     a recommended noninvasive approach of identifying the source of small bowel bleeding.~      Management of ASA-associated small bowel bleeding is a major clinical challenge since there~     is not a single effective treatment for small bowel ulcer, and continuation of ASA increases~     the risk of recurrent small bowel bleeding. However, discontinuation of ASA exposes patients~     to thrombotic complications. Suppression of prostaglandin synthesis is an important mechanism~     of ASA-induced small injury. Consistent with this theory, preliminary data from a case series~     showed that misoprostol, a prostaglandin analog, healed small bowel ulcers in ASA users.~     However, the efficacy of misoprostol in healing ASA-associated small bowel ulcers has not yet~     been confirmed by prospective randomized trials.~      This double-blind clinical trial tests the hypothesis that misoprostol can heal small bowel~     ulcers in Aspirin users complicated by small bowel bleeding.~   "
119852|NCT01998763|"~     This is a double-blind, randomized, placebo-controlled trial. Based on inclusion and~     exclusion criteria, 400 eligible volunteers, who were 20-45 years, with 25-hydroxyvitamin D~     between 12.5-50 nmol/L and BMI between 18.5-28 kg/m2, were enrolled and randomly assigned to~     placebo or 2000 IU/d vitamin D3 arm, after taking placebo for one week. The study protocol~     was approved by the Ethics Committee of Huadong Hospital Affiliated to Fudan University,~     Shanghai and all participants provided written informed consents.In this 2-arm RCT we aimed~     to systematically investigate the effect of:~        1. vitamin D3 supplement on serum 25(OH)D levels and the modifying factors;~        2. genetic and non-genetic variants on vitamin D bioavailability;~        3. vitamin D3 supplementation on metabolic profiles and circulating bone-turnover markers~   "
119853|NCT01998750|"~     This study aims to investigate genetic causes of early childhood obesity.~      The investigators will enroll children and young adults with severe early onset obesity (BMI~     > 99th percentile) diagnosed prior to 6 years of age. The investigators will ask questions~     about the health and eating behavior of the participants, and perform a brief physical~     examination. The investigators will collect saliva or blood to perform genetic testing from~     the participants and invite family members to enroll in the study.~   "
119854|NCT01998737|"~     Osteoporosis is a disease that leads to impaired skeletal strength and increased fracture~     risk. Among 200 million osteoporotic patients (Tarantino, Cannata et al. 2007) most are~     diagnosed only after several fractures. Furthermore, the progressively aging population will~     increase the prevalence of osteoporosis. It is estimated that over 75% of osteoporotic~     patients are not diagnosed and does not receive treatment for their condition.~      In this study we aim to investigate the strength of Density Index (DI) for prediction of~     proximal femur and lumbar spine BMD as well as determining the diagnostic thresholds for DI~     for osteoporosis diagnostics by using the International Society for Clinical Densitometry~     guidelines. In addition we aim to investigate how many additional women would be identified~     for osteoporosis diagnosis/ treatment based on adding FRAX to Bindex versus adding FRAX to~     DXA.~      The investigators will start and organize a multicenter study in 5 osteoporosis clinics in~     Suomen Terveystalo Healthcare Service Company in Finland. A total of 1100 postmenopausal~     women (age 50 -79 years) will be measured with both axial DXA and Bindex. In addition, the~     FRAX questioinnaire will be asked from everybody attending the study.~      Clinical hypotheses:~        1. Cortical bone thickness is decreased in osteoporosis.~        2. Patient age, weight and height are related to BMD status and therefore are needed in BMD~          estimation (Density Index).~        3. Ultrasound is a safe method in osteoporosis screening and diagnostics for osteoporosis.~        4. Fracture risk factors (FRAX) and point-of-care bone density measurement together have~          significantly higher sensitivity and specificity for osteoporosis/treatment decisions~          than one method alone.~   "
119855|NCT01998724|"~     The main purpose of this study is to determine the feasibility and effects of a 6-month tai~     chi exercise program as compared to a 6-month group walking program and standard care for~     patients with COPD that have recently completed a pulmonary rehabilitation program.~   "
119856|NCT01998711|"~     Aims:~      To evaluate the efficacy of a brief intensive intervention for persons with mild cognitive~     impairment, assisted by family members or friends. To equip persons with mild cognitive~     impairment with specific skills to prevent memory failures and improve the capacity of~     patients and families to cope with everyday memory difficulties.~   "
119857|NCT01998698|"~     The investigators would like to assess whether monovision correction of multifocal lens~     insertion provides more satisfaction to cataract patients following an uncomplicated~     phacoemulsification surgery.~   "
119858|NCT01998685|"~     This study aims to assess if different anesthetic techniques can affect coagulant factors in~     patients with prostate cancer undergoing elective laparoscopic radical prostatectomy (LRP).~   "
119859|NCT01998672|"~     The purpose of this study is to assess the safety and tolerability of the FXR agonist Px-102~     in healthy subjects after 7 days multiple oral dosing.~   "
119860|NCT01998659|"~     The purpose of this study is to assess the safety and tolerability of the FXR agonist Px-102~     in healthy subjects after single oral dosing.~   "
119861|NCT01998646|"~     The purpose of this study is to explore the safety, tolerability and pharmacokinetics (PK) of~     single ascending oral doses of ASP4058 in non-elderly, healthy male and female subjects. This~     study will also explore the effect of food on the PK of ASP4058.The food-effect crossover~     group was open-label treatment with no placebo control.~   "
119887|NCT01998308|"~     Study design:~      Allocation: Randomized. Endpoint Classification: Comparative Study. Intervention model:~     Parallel Assignment. Masking: Double Blind (Subject, Assessed) Primary purpose: Comparison.~      Official Title: Intra-articular hyaluronic acid knee injection: randomized control trail.~      Primary outcome measures:~        -  Lower extremity functional scale~        -  Visual analogue scale~        -  Range of motion~        -  Kellgren and Lawrence class grade Estimated enrollment: 100 Study start date: December~          2012 Estimated study completion date: June 2013 Estimated primary completion date:~          December 2013~   "
119862|NCT01998633|"~     HLH, HLH-related disorders, Chronic Granulomatous (CGD), HIGM1, Immune dysregulation,~     polyendocrinopathy, enteropathy, and X-linked inheritance (IPEX) and severe LAD-I represent~     primary immune disorders that are typically fatal without Hematopoietic Cell Transplant~     (HCT). However, transplant is often complicated by inflammation, infection and other~     co-morbidities. In addition, these disorders have been shown to be cured with partial~     chimerism, making them an ideal target for the use of reduced intensity approaches, where a~     portion of patients may not achieve full donor chimerism, but instead achieve stable mixed~     chimerism. Reduced-intensity conditioning strategies have demonstrated improved survival with~     decreased Treatment Related Mortality (TRM) in institutional series for patients with HLH~     (Cooper et al., 2006; Marsh et al., 2010; Marsh et al., 2011). However, graft loss and~     unstable chimerism remain challenges. An institutional case series from Cincinnati Children's~     Hospital demonstrated full or high-level chimerism and improved durable engraftment using~     intermediate (Day -14) timing alemtuzumab (Marsh et al., 2013b). This study aims to test the~     efficacy of the Intermediate RIC strategy in a prospective multi-center study including HLH~     as well as other primary immunodeficiencies where allogeneic transplant with RIC has been~     shown to be feasible and stable chimerism is curative.~   "
119863|NCT01998620|"~     This is an evaluation of adenosine methionine for treatment of chronic hepatitis b patients~     with cholestasis efficacy and safety of multicenter, randomized, open label clinical trial.~   "
119864|NCT01998607|"~     Osteonecrosis of the Jaw (ONJ) is an adverse effect of antiresorptive therapy that is~     well-recognized in patients with advanced cancer. Detailed information regarding this risk is~     specified in the Summary of Product Characteristics (SPC). The statements in the SPC are the~     most important mechanism for minimizing the risk for ONJ. The study objective is to measure~     the knowledge of oncology practitioners prescribing XGEVA® regarding the content pertaining~     to ONJ in the SPC after commercial availability.~   "
119865|NCT01998594|"~     The objective of this study is to show that using FlexHD® (or HADM) to fill the empty space~     created by removal of the trapezium improves the subject's outcome and subsequent~     functionality of the basilar joint arthroplasty procedure.~   "
119866|NCT01998581|"~     This is a multicenter, double-blind, randomized, controlled study of the safety and~     effectiveness of JUVÉDERM VOLBELLA® XC Injectable Gel versus Restylane-L® for lip and~     perioral enhancement.~   "
119867|NCT01998568|"~     The investigators conduct this study to access the effect of corneal edema (the investigators~     are particularly interested in those who have the clinical central corneal edema) on the~     variation of intraocular pressure values measured by 3 commercial-available tonometers~     compare to the current gold standard tonometer; Goldmann applanation tonometer.~   "
119868|NCT01998555|"~     The purpose of this study is to evaluate medical cost-effectiveness, reduce the psychological~     risk factors( including hostility, anxiety, depression, and perceived stress) in coronary~     artery disease (CAD) patients and enhance the regulation of the autonomic nervous system~     (including respiration rate, heart rate, distal blood vessel pulse, and finger temperament)~     through web-based cognitive -behavioral group therapy.~   "
119869|NCT01998542|"~     The purpose of this study is to determine the safety and tolerability of personalized~     anti-cancer vaccine AlloVax(TM) in Subjects with confirmed recurrent or metastatic squamous~     cell carcinoma of the head and neck (SCCHN) who cannot be treated with surgery, chemotherapy~     or radiation. AlloVax(TM) is a personalized anti-cancer vaccine combining Chaperone Rich Cell~     Lysate (CRCL) as a source of tumor antigen prepared from patient's tumor and AlloStim(TM) as~     an adjuvant. The combination of CRCL and AlloStim(TM) is designed to provide all the key~     components necessary to develop tumor-specific immunity creating the inflammatory environment~     necessary to overcome the HNC immunosuppressive environment, breaking tumor immune tolerance,~     and provision of specific HNC antigens for generation of a specific adaptive anti-tumor~     response.~   "
119870|NCT01998529|"~     The goal of this clinical research study is to find the highest tolerated dose of heated~     cisplatin that can be given to patients with lung tumors. The safety of this drug will also~     be studied.~   "
119871|NCT01998516|"~     Scientific Background~      Emotional Intelligence (EI) as a part of social cognition is a rather new area of interest~     which focuses on personality traits and abilities enabling people to cope with both their own~     feelings as well as those of others. The Mayer-Salovey-Caruso-Emotional-Intelligence-Test~     (MSCEIT) (1) represents a valid and reliable instrument which exclusively covers the~     emotional components of social cognition. Recent findings indicate, that social cognitive~     impairments are useful vulnerability indicators and that EI could be an endophenotype for~     schizophrenia and bipolar I disorder (BD I). To confirm the endophenotype theory, studies~     concerning EI in relatives of schizophrenia and bipolar patients are needed. To date, studies~     on EI in BD patients as well as in first degree relatives of patients with schizophrenia or~     BD haven`t been conducted yet. Accordingly, the current study focuses on the four categories~     assessed by the MSCEIT and aims to compare the task performance of patients, their first~     degree relatives and healthy control subjects. We assume that the task performance of~     relatives lies between that of patients and controls. The confirmation of this assumption~     would verify the trait marker hypothesis and could be a next step to identify a heritable~     endophenotype for schizophrenia and BD.~      Hypotheses~      Compared to healthy control subjects patients suffering from schizophrenia or BD I show~     deficits in EI. Siblings of patients with schizophrenia or BD I show deficits in EI and their~     task performance lies between that of patients and healthy controls. Deficits in EI are more~     pronounced in schizophrenia patients than in patients with BD I and are more pronounced in~     siblings of schizophrenia patients than in siblings of patients with BD I. Independently of~     diagnosis, deficits in EI affect patients' functional and subjective outcomes.~      Methods~      Emotional Intelligence will be examined using the MSCEIT in patients with schizophrenia,~     siblings of schizophrenia patients, patients with BD I, siblings of BD I patients and healthy~     volunteers matched for age, sex, and educational level. Structured clinical interviews~     according to DSM-IV (M.I.N.I. + SCID II) will be carried out to assure the diagnosis of~     schizophrenia or bipolar disorder as well as to detect (comorbid) Axis I and Axis II~     psychiatric disorders (patients, siblings, control subjects). Functional outcome will be~     assessed by using the GAF (Global Assessment of Functioning Scale) and the PSP (Personal and~     Social Performance Scale), subjective quality of life will be examined using the BELP~     (Berliner Lebensqualiätsprofil). The MWT-B (Multiple choice vocabulary test) will be used to~     assess premorbid intelligence.~   "
119872|NCT01998503|"~     This randomized phase III trial is studying the side effects and how well giving induction~     therapy with bortezomib and dexamethasone followed by autologous stem cell transplantation~     (ASCT) compared with ASCT alone in treating patients with newly diagnosed renal AL~     amyloidosis. In this prospective, randomized control study, patients with newly diagnosed AL~     amyloidosis who met the criteria for ASCT were randomized to receive 2 cycles of BD as~     induction therapy followed by ASCT (BD+ASCT) (arm 1) or to receive ASCT alone as an initial~     treatment (arm 2). Hematologic and organ responses were evaluated every 3 months after ASCT.~     All the patients should be followed up for 12 months.~   "
119888|NCT01998295|"~     Plasmodium falciparum resistance against artemisinins has been confirmed in South-East Asia~     and it is expressed phenotypically as a slow rate of parasite clearance. Nonetheless, it is~     not known whether the problem exist in Tanzania. This study assessed parasite clearance time~     and time to recurrent infection following treatment with Artemether/Lumefantrine (AL) among~     children with uncomplicated malaria.~   "
119873|NCT01998490|"~     The overall research aim of this study is to investigate changes in measures related to the~     risk of falls among elderly with dementia participating in animal-assisted or robot-assisted~     interventions. In addition the study will investigate how knowledge transfer occurs among~     involved health personnel, and how knowledge is refined and transformed as practical~     competence. The design will be a prospective and cluster randomized multicenter trial, but~     mixed-methods will be used to target different outcomes. The study population will be elderly~     (age above 65) at nursing homes diagnosed with dementia, or having a cognitive deficit. The~     intervention will consist of 30 minutes sessions with animal-assisted activity or~     robot-assisted activity two times a week for 12 weeks in groups of 4-6 participants. Control~     groups will receive treatment as usual. Research questions:~        1. Is there an effect in use of ordinary and optional medication among elderly persons with~          dementia at nursing homes participating in animal-assisted or robot-assisted~          interventions compared to a control group?~        2. Is there an effect on agitation, restlessness and depression among elderly persons with~          dementia at nursing homes participating in animal-assisted or robot-assisted~          interventions compared to a control group?~        3. Is there an effect on social interaction, activeness and wellbeing among elderly persons~          with dementia at nursing homes participating in animal-assisted or robot-assisted~          interventions compared to a control group?~   "
119874|NCT01998477|"~     The study is designed to evaluate the safety of TIVc or TIV vaccine in children 3 to < 18~     years of age who are at risk of complications of influenza disease due to underlying~     diseases.~   "
119875|NCT01998464|"~     Retinal vasculitis is a sight-threatening inflammation that involves the blood vessels of the~     retina, the tissue that lines the inside of the eye. This inflammation may occur on its own~     or as a result of an infectious, cancerous, or inflammatory disorder.~      Optical coherence tomography (OCT) is an imaging technology that can perform non-contact~     cross-sectional imaging of retinal and choroidal tissue structure in real time. It is similar~     to ultrasound imaging, except that OCT measures the intensity of reflected light rather than~     sound waves.~      The purpose of this study is to see if non-invasive OCT technology can diagnose retinal~     vasculitis as well as the more invasive fluorescein angiography, which requires an injection~     of dye into the vein of an arm of a patient. The study will also compare the mapping of blood~     vessels (angiography) and loss of blood flow (ischemia) by fluorescein angiography and OCT.~   "
119876|NCT01998451|"~     We found a new Double sphincter which located in the neck of gallbladder，we supposed it may~     be related to control pressure of bile duct.Its formation is related to genetic factors.~   "
119877|NCT01998438|"~     Tranexamic acid, an antifibrinolytic drug, is wildly used in cardiac surgeries to decrease~     perioperative bleeding and allogenic transfusion. But the optimum dose of tranexamic acid is~     still unknown. We use three different doses to find which is the optimum dose of tranexamic~     acid in cardiopulmonary bypass cardiac surgery.~   "
119878|NCT01998425|"~     The investigators will collect fibrocytes (CD45+Col-1+) in patients with non-small cell lung~     cancer (NSCLC). The investigators hypothesize that patients with NSCLC experience expansion~     of immunosuppressive fibrocytes, which are predicted to augment tumor growth by mediating~     immune escape in NSCLC patients.~   "
119879|NCT01998412|"~     The study will include any patient treated with Iluvien at designated sites in European~     countries where marketing authorization has been granted in order to obtain broader safety~     and usage information.~   "
119880|NCT01998399|"~     The purpose of this study is to determine if the drug ticagrelor will be an effective~     treatment for patients with severe community acquired pneumonia. The primary objective is to~     reduce all-cause mortality in the ticagrelor group compared to the placebo group.~   "
119881|NCT01998386|"~     The specific objective of this study is:~        -  Evaluate and quantify colorimetric changes in young permanent anterior teeth;~        -  Compare the efficiency and efficacy of three gels used for self-administered home~          whitening and an over the counter whitening strip;~        -  Analyze the increase in dental sensitivity in adolescent patients submitted to home~          whitening with 6% and 7.5% hydrogen peroxide with and without the addition of calcium~          (whitening strips);~        -  Assess sensitivity, comfort and acceptance of whitening strips by patients;~        -  Assess patient satisfaction with the method and material used for home whitening.~   "
119882|NCT01998373|"~     Abstract~      Background:~      It is documented that some patient education interventions, preferably with a behavioral~     component included, may improve pain, disability and moods Purpose of the study: the purpose~     of this study was to improve the quality of life and reduce pain in rheumatoid arthritis~     patients.~      Methods:~      Patients were allocated to a patient training intervention group and patient without training~     intervention group. Both groups received routine treatments while the patient training~     intervention group, in addition to the routine treatments received training booklets and~     participated in the training workshop. All the extracted data from the written questionnaire~     were collected and analyzed using SPSS software.~   "
119883|NCT01998360|"~     This study will evaluate a new, minimally-invasive surgical circumcision technique for men,~     which is easy to learn and perform, is safe, and is associated with high patient satisfaction~     and excellent cosmetic results.~   "
119884|NCT01998347|"~     There are no standard chemotherapy regimens for metastatic esophageal cancer. Cisplatin plus~     5-fluorouracil is widely used as first-line treatment with a response rate ranged from 30% to~     40%. Combination of paclitaxel and cisplatin has been investigated in small size clinical~     trial, producing promising outcome.Liposome capsuled paclitaxel has been proved to be as~     effective as paclitaxel.The usefulness of the the regimen of paclitaxel liposome with~     cisplatin is evaluated by median survival time, progression free survival,and response rate.~   "
119885|NCT01998334|"~     Systemic Inflammatory response syndrome(SIRS) is common in patients with severe acute~     pancreatitis (SAP) in early stage. Continuous Blood Purification (CBP), especially Continuous~     Veno-Venous Hemofiltration(CVVH) is proved to have an important role in SAP patients to~     control SIRS. But the detail treatment for this is controversial. In this study, the~     investigators aim to evaluate the different effects of three kinds of treatment protocols~     which is CVVH 6h,continuous venovenous hemodiafiltration(CVVHDF) 6h,CVVH 10h for first three~     days in SAP patients. Compare the vital sign, SIRS parameters, and others between these three~     groups. This study will try to find a better way for CBP in patients with SAP~   "
119889|NCT01998282|"~     DelAgua Health and Development, Manna Energy and the Rwanda Ministry of Health are~     collaborating on a project financed by carbon credits that will distribute household-based~     water filters and high-efficiency cook stoves to approximately 600,000 households in Rwanda.~     Prior to the full roll out of the campaign, the implementers are conducting research in~     connection with a distribution among 2000 households in western Rwanda. The objective of this~     matched cohort study (Phase 1B)are to investigate whether the filters and stoves delivered in~     October 2012 are still performing and in use, to determine whether they are associated with~     reductions in exposure to pathogens from drinking water and stoves, and to assembly~     information on health and other conditions necessary for the design of a large scale health~     impact evaluation.~   "
119890|NCT01998269|"~     The study objective is to develop and test a Measure of Drug Self-Management for use in~     clinical settings among patients with hypertension and diabetes.~      While medication non-adherence is a highly recognized public health and patient safety~     concern, it is rarely assessed in a routine and consistent manner in clinical settings. With~     the aging of the US population and rising rates of chronic disease, an increasing number of~     adults are being prescribed multi-drug regimens that require greater self-management skills.~     Despite the complexity of medication use, adherence has most commonly been measured as a~     limited set of behaviors (i.e., filling a prescription, taking doses). This emphasis has,~     over time, simplified how we think of prescription (Rx) medication use and directed attention~     away from the full range of tasks associated with effective Rx self-management. The field of~     health literacy research has deconstructed these tasks in considerable detail in recent~     years, and can offer insight into a more comprehensive measurement of patients' outpatient Rx~     use.~      There is a clear need for a brief, yet inclusive, measure of adherence that can be used in~     clinical settings to routinely assess patients' use of complex Rx regimens. Such an~     assessment could be used to guide clinicians in addressing specific patient challenges to~     safe and appropriate medication use. In response to this need, our study proposes to develop~     a new assessment of medication self-management. This unique measure will utilize health~     literacy best practices to promote patient comprehension and ease-of-use; it will also be~     tailored to patients' actual regimens via electronic health record (EHR) data. Finally, the~     tool will be available in both English and Spanish to support use among diverse patient~     populations. Our study aims are to:~        1. Develop and refine a Measure of Drug Self-Management (MeDS) prototype.~        2. Inform the content, structure and delivery of the MeDS through targeted discussions with~          patients, providers and information technology specialists.~        3. Test the reliability and validity of the MeDS among patients with diabetes and~          hypertension~      H1: The MeDS will strongly correlate with other self-report adherence measures.~   "
119891|NCT01998256|"~     Though AV optimization has become a cornerstone in optimization of patients with a cardiac~     resynchronization therapy (CRT) device, surprisingly the use of AV optimization in patients~     with a dual chamber (bicameral (BIC)) pacemaker is not fully implemented in daily clinical~     practice. Some patients with a BIC pacemaker have a too short AV delay (AVD), secondary to an~     important interatrial conduction delay (IACD), which can lead to an atrial dyssynchrony~     syndrome. Others have a too long AV delay, also leading to a suboptimal diastolic filling~     time. Some patients may not need an optimization. Our aim was to evaluate the effect of AV~     optimization in all comer ambulatory patients with a BIC pacemaker on clinical outcomes, with~     a correlation to atrial pathophysiology, since until now existing evidence only emphasizes a~     possible hemodynamic benefit of this non invasive intervention.~   "
119892|NCT01998243|"~     Introduction: bariatric surgery shows an important morbidity and there are some reports that~     have used preoperative intragastric-balloons (IGB-BIB®) to decrease surgical morbidity.~      Patients Methods: Since 2009 we are performing a randomized and prospective study to assess~     the usefulness of (IGB-BIB®) before bariatric surgery [sleeve resection (SR) or gastric~     bypass (GB)] group A vs a control group B with the same type of surgical procedures but~     without preoperative IGB-BIB. All patients coming for both groups were followed at 4-week~     intervals by a nurse practitioner and dietitian for 6 months, Nurse practitioner made the~     dietetics adjustments (750-1500 Kcal) , provide advice and assess the evolution of weight~     loss The hypothesis was that preoperative IGB-BIB helps the patients to lose weight ( more~     than 10%) ,and the weight loss will contribute to decrease surgical morbidity by at least~     30%, and also will decrease hospital stay Objective: to check if morbidity, mortality and~     hospital stay decreased in the IGB-BIB ® group, and secondly if the weight before surgery was~     associated with surgical morbidity. secondary objective : Assess the rate of IGB-BIB~     failure.Intragastric balloon failure was considered when the weight loss is less than 10%~     from the initial weight. We defined severe complication whenever the patient had to be~     admitted in the hospital after discharge, new surgeries or transfusions were required or the~     hospital stay was longer than 7-10 days.~   "
119893|NCT01998230|"~     The purpose of this study is to determine the feasibility of early oral food intake~     postoperatively in patients with thoracolaparoscopic esophagectomy. More and more evidence~     confirmed the role of early early enteral nutrition (NE) after esophagectomy in patients with~     esophageal cancer. Although enteral catheter feeding has been shown to be beneficial in~     patients with esophagectomy, the preference for this modality also rests on the traditional~     but undocumented reluctance to allow food at will. These assumed hazards of allowing normal~     food in the immediate postoperative period have not been scientifically tested and should be~     viewed against both the benefits and side effects of any artificial feeding modality. Whether~     early oral feeding after esophagectomy affects the incidence of life-threatening surgical~     complications, shortens the recovery time of bowel function and the postoperative hospital~     stay, improves postoperative quality of life in comparison with artificial feeding modality~     remains unclear. The investigators compared a routine of allowing liquid food at will from~     the first day after surgery with a routine of nil-by-mouth and enteral nutrition for the~     first 7 postoperative days. The main endpoint is the incidence rate of complications.~   "
119894|NCT01998217|"~     Extracorporeal shock wave lithotripsy (ESWL) of pancreatic stones has been described as an~     effective approach for stone drainage and pain relief, and general or epidural anesthesia has~     been reported for such procedure. Single infusion of remifentanil has been described in ESWL~     of urinary stones, but it has never been described in ESWL of pancreatic stones. Moreover,~     single infusion of remifentanil might induce several complications, such as postoperative~     nausea and vomiting. The investigators attended to investigated whether combination of~     flurbiprofen with remifentanil reduced remifentanil dose and attenuated the complications.~   "
119895|NCT01998204|"~     Parkinson's disease (PD) is the second most prevalent neurodegenerative disease. The~     investigators clinical experience showed a trend of delayed emergence among patients~     undergoing deep brain stimulator (DBS) implantation and pulse generator placement under~     general anesthesia. Abnormal pharmacodynamics might be present among these patients, which~     had never been investigated.~   "
121308|NCT01979653|"~     The purpose of this study is to compare midazolam-dexmedetomidine with dexmedetomidine alone~     for hemodynamic stability and quality of sedation in elderly patients under spinal~     anesthesia.~   "
119896|NCT01998191|"~     TITLE A randomized controlled trial to assess the best method for evaluating avoidable~     mortality in hospitals using medical record review.~      DESIGN Randomised controlled trial This trial will be conducted in concordance with the~     CONSORT guidelines for randomised controlled trials.~      AIMS Compare explicit versus implicit case review methods for detecting avoidable mortality~     in patients who have died in hospital Assess the accuracy and efficiency of physicians versus~     nurses in detecting avoidable mortality in patients who have died in hospital~      OUTCOME MEASURES Rate of adverse event detection between explicit and implicit review methods~     Type of adverse event detection between explicit and implicit review methods~      Kappa score of agreement for inter-rater reliability for the above outcomes:~        -  Between individual reviewers within using the same review method~        -  Between different reviewer types.~      PARTICIPANTS Physician reviewers and nurses No patient participation. Case records of~     patients who had inpatient hospital mortality will be reviewed.~      ELIGIBILITY Over 18, Able to consent, English Language Speaking, Able to participate in case~     note review training, appropriate level of clinical experience.~      DURATION 2 years with extension if required and reviewed.~   "
119897|NCT01998165|"~     The purpose of this study is to evaluate the efficacy and safety of JNJ-268229 (Ultiva~     /Remifentanil Hydrochloride) in pediatric participants between 1 and 15 years of age during~     maintenance of general anesthesia.~   "
119898|NCT01998152|"~     The purpose is to study the effect of individualized nutritional counselling compared to~     usual nutritional care on cross-sectional muscle area in patients with stage IV colorectal~     cancer during first line chemotherapy. Secondary, effect on total lean body mass, treatment~     intensity, physical functioning, quality of life and survival will be studied.We hypothesize~     that patients in the intervention arm benefit from individualized nutritional counseling.~   "
119899|NCT01998139|"~     Sepsis is a major global health problem, leading to substantial morbidity and mortality~     despite medical care. The initial diagnosis of sepsis is a clinical challenge, as it is based~     on nonspecific systemic criteria. Excessive endothelial activation is a cardinal feature of~     sepsis and contributes to microvascular leak, edema, circulatory shock and organ failure.~     Activated endothelial cells shed endothelial microparticles (EMPs) which can be measured in~     plasma and are found at low levels in healthy subjects. Elevated EMPs have been reported in~     sepsis, but whether their effect is beneficial or deleterious is unclear. In this context, we~     hypothesize that circulating EMP levels can be assessed as a biomarker differentiating sepsis~     from non-sepsis critical illness. This may also suggest that EMP levels correlate with 30-day~     mortality. We propose to measure circulating EMPs at ICU admission in subjects with suspected~     sepsis. Final diagnoses will be adjudicated using standard criteria and 30-day mortality~     ascertained. Subjects determined not to have sepsis will serve as the control group. EMP~     levels will be correlated with diagnosis to ascertain the utility of EMP levels as a~     diagnostic biomarker for sepsis. For those subjects with proven sepsis, EMP levels will be~     correlated to 30-day mortality to assess EMP level as a prognostic marker in sepsis.~   "
119900|NCT01998126|"~     The goals of the overall study are to evaluate a recommended phase 2 dose and the short and~     long term toxicities of the combinations. This is a modified phase I trial of immune~     checkpoint inhibitors in combination with mutation - specific targeted therapy (crizotinib or~     erlotinib) at conventional doses stratified for presence of ALK (Anaplastic lymphoma kinase)~     or EGFR (epidermal growth factor receptor) mutation.~      The goals of the overall study are to evaluate a recommended phase 2 dose and the short and~     long term toxicities of the combinations.~   "
119901|NCT01998113|"~     Since the publication in the New England Journal of Medicine (NEJM) in 2000 of the Langer's~     trial comparing glyburide vs insulin in the treatment of gestational diabetes mellitus (GDM),~     additional studies of oral agents for the treatment of GDM have been published~     (observational, randomized controlled trials (RCT), and trials using other drugs like~     metformin).~      Some meta-analysis to summarize the evidence have been published: Nicholson 2009 (including 4~     RCT addressing different drugs), Dhulkotia 2010 (including 6 RCT addressing different drugs,~     the meta-analysis combining all drugs altogether), Gui 2013 (including 5 RCT addressing~     metformin vs insulin).~      Oral agents are increasingly used for the treatment of GDM. Investigators aim to update the~     evidence on RCTs comparing glyburide and metformin vs insulin or between them and summarize~     this evidence using meta-analysis tools. Specifically, investigators aim at producing~     distinct meta-analyses for each one of the three drug comparisons. This information is not~     available in the literature since the most recent systematic reviews specifically dealing on~     oral agents for the treatment of GDM have addressed a single drug comparison (Gui 2013) or~     have combined different drug comparisons into a single meta-analysis (Dhulkotia 2010)~   "
119902|NCT01998100|"~     The purpose of this study is to examine the efficacy of exercise + therapy to therapy alone~     to determine if they can improve the effects of prolonged exposure therapy (PE) in reducing~     symptoms of anxiety associated with Post-traumatic Stress Disorder (PTSD). In addition the~     two strategies (i.e., exercise + therapy and therapy alone condition) will be compared in~     terms of levels of brain-derived neurotrophic factor (BDNF). BDNF is a protein that helps to~     support the survival of existing neurons and stimulate the growth of new neurons and~     synapses. BDNF is important to learning and memory in general and therefore may be associated~     with the learning and memory as it relates to PE and corresponding symptoms PTSD improvement.~   "
119933|NCT01997697|"~     Recent studies show that overweight people have a greater sensitivity to the rewarding aspect~     of food due to the disturbance of the dopaminergic system. These perturbations lead to a~     greater amount of food to satisfy this rewarding aspect. Then, this rewarding aspect to food~     would also facilitate food intake related to emotions, whether they are positive or negative.~     However, the food intake in response to emotions can be modulated by physical activity. But,~     there are no interventional studies in the literature examining the behavioral and biological~     factors related to emotional eating together with the fact, there are few data on the~     explanatory mechanisms. The purpose of the study is to evaluate the predictive factors of~     emotional eating 6 months after a behavior change program adapted to the motivational state~     and to identify the its underlying mechanisms~   "
120091|NCT01995630|"~     The purpose of this study is to evaluate differences in the depth of focus after implantation~     of a spherical or aspheric IOL in hypermetropic and emmetropic patients. After implantation~     of a spherical IOL hypermetropic patients may achieve a better depth of focus compared to~     emmetropic patients due to a larger amount of spherical aberrations.~   "
119903|NCT01998087|"~     In Croatia, between 95% and 99% of mothers initiate breastfeeding, but by 3 months a third~     have stopped, and by six months only half are still providing any human milk for their~     babies. Exclusive breastfeeding rates are even lower, with only about 9% of Croatian mothers~     exclusively breastfeeding at 6 months, despite the WHO recommendation of 6 months of~     exclusive breastfeeding. Currently, in Croatia, no breastfeeding information or other~     pregnancy and parenting related written information is routinely provided to expectant~     couples. In our study we would like to find out whether providing written breastfeeding~     information in pregnancy and breastfeeding focused support phone calls during pregnancy and~     after the birth of the baby result in better outcomes than providing general~     pregnancy/parenting information and support phone calls. This will be tested by randomising~     women, attending their primary health care provider for routine antenatal visits between 20~     and 32 weeks, to an intervention focused on promoting and supporting breastfeeding, to an~     intervention focused on general pregnancy and parenting issues, and to a non-intervention~     control group. Women will be followed-up for 6 months after the birth of their baby and data~     will be collected at 3 and 6 months on breastfeeding rates, breastfeeding self-efficacy,~     breastfeeding difficulties, social support and attitudes toward infant feeding.~   "
119904|NCT01998074|"~     The aim of the study is to show the efficacy, tolerance and nutritional adequacy of a newly~     developed hydrolyzed rice formula in infants with a proven cow's milk protein allergy.~   "
119905|NCT01998061|"~     There have been reports suggesting that continuous administration of epidermal growth factor~     receptor-tyrosine kinase inhibitors (EGFR-TKIs) is advantageous for patients in which gradual~     disease progression was observed after the establishment of clinical benefit from EGFR-TKIs.~     However, whether EGFR TKI with or without chemotherapy provides more survival benefit has not~     been formally evaluated.~   "
119906|NCT01998048|"~     Glenohumeral joint is prone to instability, i.e. the humeral head may dislocate off the~     scapular glenoid plate especially in the anteroinferior direction. Surgical treatment of~     shoulder instability aims at restoration of shoulder stability. The purpose of this trial is~     to investigate the difference in outcome after arthroscopic Bankart operation compared with~     open Latarjet operation in the treatment of a residual instability after a traumatic primary~     dislocation in young males.~   "
119907|NCT01998035|"~     This is an open label, phase I/IIa, 3 x 3 dose escalation study with an initial phase I~     followed by a disease focused phase II.~      The primary objective of the phase I is to determine the maximum tolerated dose (MTD) and~     dose limiting toxicity (DLT) of the combinations of oral 5-azacitidine and romidepsin in~     patients with lymphoma. The safety and toxicity of this combination will be evaluated~     throughout the entire study.~      If the combination of oral 5-azacitidine and romidepsin is found to be feasible and an MTD is~     established, the phase II part of the study will be initiated.~      Phase II will consist of a 2 stage design of the combination of oral 5-azacitidine and~     romidepsin for patients with relapsed or refractory T-cell lymphomas.~   "
119908|NCT01998022|"~     Numerous studies highlight the insufficiency of blood pressure control in treated~     hypertensive population [1].~      As shown in the MONICA study, increased cardiovascular mortality is found in Alsace compared~     to other french regions. The incidence and prevalence of diabetes and obesity are likely~     explanatory factors leading to this excess mortality [2].~      Furthermore, the incidence and prevalence of alsacian patients with end-stage renal failure~     (ESRD) is also higher than the national average. The high prevalence of diabetes,~     hypertension and obesity in this population is also probably responsible for the high~     prevalence of ESRD [3].~      Opportunities to prevent the progression of kidney disease involve an optimal control of~     treatable evolutionary factors.~      Beyond control of diabetes and obesity, optimization of blood pressure control are an~     important factor to consider, as national and international guidelines recommend lower blood~     pressure targets in this population [4]. Knowledge of the disease and treatment goals are a~     key component of hypertensive patient management. Studies have shown that the knowledge of~     hypertensive disease and therapeutic targets were correlated with treatment compliance and~     with the rate of blood pressure control [5]. Patient education and participation of~     non-medical actors (nurses, pharmacists, …) are likely to improve the management and~     treatment compliance of these patients [6]. To our knowledge, no investigation has been~     performed in our region to determine the epidemiological characteristics, the knowledge level~     and blood pressure control in the population of hypertensive patients. The main objectives of~     this observational study are to evaluate, in a treated hypertensive population:~      the knowledge level of the blood pressure treatment goals, the impact of patient knowledge on~     this blood pressure control, the potential impact of the patient's comorbidities on his blood~     pressure control.~      Such a study should provide the basis for the feasibility of a large survey.~   "
119909|NCT01998009|"~     The objective of this study is to compare the performance characteristics or accuracy of~     different in-home screening tests for colorectal cancer (fecal occult blood tests), among~     patients without symptoms of colorectal cancer. Patients who meet study eligibility criteria~     and agree to participate in the study are asked to perform one guaiac and two immunochemical~     fecal occult blood tests at home prior to their colonoscopy. After the patient has completed~     and sent in the test kits, the patient then undergoes their previously scheduled colonoscopy.~     Accuracy and performance characteristics for each type of fecal occult blood test, including~     sensitivity, specificity, test positivity rate and positive predictive value for advanced~     colorectal neoplasia (advanced colorectal polyps) or colorectal cancer, will be estimated by~     comparing the fecal occult blood test results with the results of the colonoscopy.~   "
119910|NCT01997996|"~     Transvaginal meshes (TVM) are indicated for the treatment of pelvic organ prolapse (POP)~     where surgical intervention is necessary. Due to a potential risk of de novo dyspareunia, TVM~     are mainly used in postmenopausal women and in case of recurrent POP. PROLIFT+M (Trademark)~     is based on a highly flexible material which is partially absorbable. We suggest that~     PROLIFT+M has less impact on the vita sexualis than conventional TVM and could also be used~     for the treatment of younger and/or sexually active women. This study observes women who are~     routinely treated with PROLIFT+M with regard to their sexual function before and after the~     surgery. The hypothesis is that there is no worsening in vita sexualis with PROLIFT+M.~   "
119911|NCT01997983|"~     The investigators believe that this study is of importance of several aspects:~        1. It evaluates a new mode of bladder instillation that may bypass the drawbacks of the~          current instillation mode.~        2. It will demonstrating safety of intravesical instillations of BTX mixed with TC-3 gel in~          IC patients~        3. If proved effective or partially effective, this mode of treatment will serve as a basis~          for large feasibility study exploring its safety and efficacy aspects.~   "
119912|NCT01997970|"~     This study will investigate the effect on Non-exercise Activity Thermogenesis (NEAT) when~     implementing active workstation at offices compared to conventional office work. The primary~     hypothesis is that this implementation will lead to a significant increase in time spent~     walking per day.~   "
121309|NCT01979640|"~     The purpose of this study is to find the adequate additional bronchial cuff volume after~     achievement of air-tight seal, that can achieve blood-tight seal(preventing leakage of blood~     through cuff) in double lumen tube~   "
119913|NCT01997957|"~     Hepatocellular carcinoma (HCC) is one of the most commonly malignant tumors around the world~     and causes death of about 600000~1000000 people each year. Since 1990s, hepatic carcinoma has~     become the second carcinoma killer in China. Surgical resection or liver transplantation is~     the only method possibly able to cure hepatic carcinoma. However, due to multiple tumors or~     poor hepatic function reserve in cirrhosis, surgical treatment is suitable for only a small~     portion of patients (11.9%-30.1%). Therefore, in clinical practice, transarterial~     chemoembolization (TACE) or transarterial embolization (TAE) is a preferential and standard~     treatment of unresectable advanced hepatic carcinoma and has notable advantages in~     controlling local tumors of the liver. Hepatic arterial infusion of oxaliplatin after TACE~     can significantly increase the local doses of chemotherapeutic agents in the liver, kill~     micrometastases and residual foci after embolization and demonstrate outstanding efficacy for~     treating concomitant portal and hepatic vein tumor thrombi. S-1 is a chemotherapeutic agent~     with convenient use and definite efficacy and, when used concomitantly with TACE,~     theoretically can not only effectively control intrahepatic foci but also prevent and control~     extrahepatic metastatic foci. However, this hasn't been verified in clinical application.~     This study is intended to investigate efficacy and safety of the combination treatment so as~     to provide a more effective and safety way for treating patients with advanced hepatic~     carcinoma (Barcelona stage-C patients with concomitant portal vein tumor thrombi or~     extrahepatic metastasis).~   "
119914|NCT01997944|"~     This is an open label study that will be conducted at a single site in China to evaluate the~     safety,tolerability and PK/PD profile of multiple dose of recombinant human serum~     albumin/interferon alpha2a fusion protein in chronic hepatitis B patients.The total duration~     of study participation is up to 22 weeks for each subject,including 4 weeks screening period.~   "
119915|NCT01997931|"~     This prospective randomised controlled trial was designed to assess the effectiveness of the~     Bispectral Index Sedation (BIS) monitor in supporting clinical, sedation management decisions~     in mechanically ventilated ICU patients.~      The primary hypothesis for the study is that patients with Bispectral Index Sedation (BIS)~     monitoring will receive less sedation then those receiving standard sedation management.~      The secondary hypotheses are:~        1. Patients with BIS have fewer ventilation days than those receiving standard sedation~          management.~        2. Level of sedation administered will differ according to the critical care experience and~          qualification of the nurse.~   "
119916|NCT01997918|"~     Relapse of underlying hematologic malignancies after allogeneic hematopoietic stem cell~     transplantation (HSCT) is frequently treated by a second allogeneic HSCT (HSCT2). Choosing an~     alternative donor is often advocated to maximize chances of a graft versus tumour (GVT)~     effect. We and others published that success of this strategy when using an alternative human~     leukocyte antigen (HLA) identical donor is limited, at least when acute leukemia is the~     underlying disease. The aggressivity of the rapidly proliferating leukemia seems to prevail~     over GVT effects. A more potent alloimmune response is observed following haploidentical~     HSCT, especially early after haploidentical HSCT. This might be related to a fast and large~     expansion of natural killer (NK)-cells. Their alloreactive effect might translate into higher~     rates of tumor control. On the other hand, non-relapse complications (treatment related~     mortality, TRM) might be high in advanced relapsed tumour patients with heavy pretreatment~     and due to delayed immune reconstitution after haploidentical HSCT. The use of a~     haploidentical donor for HSCT2 following a first allogeneic HSCT from an HLA identical donor~     has been so far only systematically evaluated in small retrospective single center reports.~     Thus, in this multicenter study we aim to collect data on the extent to which participating~     centers employ haploidentical transplantation in the situation of relapse after HSCT2.~   "
119917|NCT01997905|"~     This is a feasibility study to assess the safety and efficacy of the AtriCure AtriClip when~     placed via Minimally Invasive Surgical Deployment to the Left Atrial Appendage. The purpose~     is for evaluation of Stroke Prevention in Patients with Non-Valvular Atrial Fibrillation who~     are unable to take Oral Anticoagulants.~   "
119918|NCT01997892|"~     To describe the time course of hemoglobin concentration in EU hemodialysis patients switched~     from methoxy polyethylene glycol-epoetin beta (PEG epoetin beta; Mircera) to darbepoetin alfa~     (Aranesp).~   "
119919|NCT01997879|"~     The purpose of this study is to assess systemic safety and absorption of AR-13324 in healthy~     volunteers.~   "
119920|NCT01997866|"~     Patients with Congestive Heart Failure (CHF) on non-Intensive Care Unit medical services~     and/or visiting our outpatient Congestive Heart Failure Clinic will be screened using the~     STOP-BANG Scoring Model. (STOP-BANG stands for Snoring, Tiredness, Observed Apnea, Blood~     Pressure, Body Mass Index, Age, Neck Circumference, Gender.) Patients with high risk of~     Obstructive Sleep Apnea (OSA) will be referred for evaluation and treatment of Sleep Apnea.~     They will be followed to determine if treatment of Sleep Apnea improves their quality of life~     and decreases their utilization of the Hospital and Emergency Department (ED).~   "
119921|NCT01997853|"~     Omega 3 fatty acids is one such dietary supplement, known to modulate the host response in~     chronic conditions like cardiovascular diseases, rheumatoid arthritis, ischemic~     cerebrovascular diseases, osteoporosis by producing Resolvins and protectins without showing~     any inadvertent effects.Addition of systemic Omega 3 Fatty Acids with SRP may enhance the~     therapeutic result of Chronic Periodontitis owing to host modulation & anti-inflammatory~     properties. If proven, this can be used as a routine treatment modality.~   "
119922|NCT01997840|"~     Phase 1b: To evaluate the side effects and determine the best dose of ACY-1215 in combination~     with Pomalidomide and low-dose dexamethasone in patients with relapsed-and-refractory~     multiple myeloma.~      Phase 2: To determine the overall response rate of ACY-1215 in combination with Pomolidomide~     and low-dose dexamethasone in patients with relapsed-and-refractory multiple myeloma~   "
119934|NCT01997684|"~     The use of colonic stenting with elective surgery has been suggested as an alternative~     management for acute malignant colonic obstruction, as emergency surgery has a high risk of~     morbidity and mortality.~      However, the available body of literature addressing their benefit in this setting is~     contradictory.~      The purpose of this study is to determine the efficacy and safety of colonic stenting with~     elective surgery versus emergency surgery in the management of acute malignant colonic~     obstruction.~   "
121345|NCT01979172|"~     The study aims at determining the best biometry calculation formula to be used in IOL~     calculation of cataract patients how previously underwent laser refractive correction surgery~   "
119923|NCT01997827|"~     Tooth loss can be addressed by different rehabilitative strategies. Implant-supported crowns~     and conventional bridges (fixed dental prostheses [FDPs]) are well established treatment~     alternatives. Implant therapy is sometimes impossible, however, because of patient-related~     risk factors or economic issues. In such cases therapy with an FDP requires extensive removal~     of tooth structure to provide enough space for the restoration and to ensure mechanical~     retention if the abutment teeth are sound. Alternatives for rehabilitation requiring minor or~     no preparation of the anchoring teeth are desirable. Resin-bonded bridges meet this demand~     for minimal invasiveness and have been used clinically successfully. Sometimes, however,~     patients choose a conventional FDP over a resin-bonded one (RBFDP) for esthetic reasons since~     the adhesive wings, which are traditionally made of a cobalt-chromium alloy, might be exposed~     while speaking or smiling or account for a colour change of the abutment teeth. Such patients~     profit from an all-ceramic RBFDP. Today, the clinical performance of metal-based and~     all-ceramic RBFDPs has not yet been evaluated under randomized controlled conditions. The aim~     of this pilot study is to calculate the sample size that allows us to accept the hypothesis~     that metal- and all-ceramic RBFDPs are similar regarding their clinical performance with~     adequate statistical power.~   "
119924|NCT01997814|"~     Addition of systemic herbal immunomodulators with scaling & root planing (SRP) may enhance~     the therapeutic result of Chronic Periodontitis owing to host modulation & anti-inflammatory~     properties. If proven, herbal immunomodulators can be used as an adjunct to SRP.~   "
119925|NCT01997801|"~     In this prospective double-blinded study, The investigators compared acute postoperative pain~     and rescue analgesic demand during postoperative period after robot thyroidectomy between~     ketamine and placebo groups.~   "
119926|NCT01997788|"~     To evaluate the efficacy and the safety of the intrathecal morphine injection in the open~     nephrectomy.~   "
119927|NCT01997775|"~     The purpose of this study is to determine whether metformin is effective in lowering plasma~     IL-6 level and improving the treatment response in patients with non-small cell lung cancer~   "
119928|NCT01997762|"~     The purpose of this study is to determine if resveratrol supplementation preserves beta cell~     function and insulin sensitivity in post-partum women following a first diagnosis of~     gestational diabetes. We hypothesize that daily supplementation with resveratrol will~     preserve beta cell function and insulin sensitivity.~   "
119929|NCT01997749|"~     The purpose of this controlled, randomized intervention is to investigate whether a fat-based~     (ketogenic) diet given for a week has a positive effect on blood sugar, mortality and~     function in patients hospitalized with acute stroke compared to the effect of a usual diet.~      The study hypothesis is that a ketogenic diet and reduced availability of glucose to the~     brain cells will reduce the volume of neuronal damage in the brain and improve function.~      The intervention will take place at the neurological units of Glostrup and Bispebjerg~     Hospital in Denmark.~   "
119930|NCT01997736|"~     The purpose of this study is to collect preliminary safety and effectiveness data evaluating~     the Toray Satake Balloon Thermal Ablation System (TSB)to treat subjects with symptomatic~     paroxysmal atrial fibrillation that is resistant to antiarrhythmic drug therapy.~   "
119931|NCT01997723|"~     Obstructive Sleep Apnea (OSA) is under-diagnosed and is associated with increased~     cardiovascular morbidity and mortality. Laboratory-based overnight polysomnography (PSG) is~     the gold standard in clinical practice to diagnose OSA but has availability, cost, and~     resource limitations. In the last decade, an alternative diagnostic strategy, Portable~     Monitoring (PM) has emerged with the goal of reducing expense and delays in clinical~     management. In contrast to PSG, PM maybe performed unattended in homes, utilize different~     neurophysiologic and cardiorespiratory parameters, and may synthesize these data differently.~     PM is feasible and is approved by Centers for Medicare and Medicaid Services (CMS) in the~     United States. However, the diagnostic utility of PM in minority and underserved populations~     is not defined.~      African-Americans are more severely affected by hypertension and cardiovascular disease (CVD)~     than other ethnic groups and OSA is more common in this population. OSA is a treatable cause~     of hypertension. Despite this the impact of timely interventions for OSA on health outcomes~     and risk reduction specific to African Americans is unknown.~      Purpose of this research: In view of the vulnerability of this population and the potential~     for improvement in healthcare access for OSA with home-based diagnosis, this study aims to~     establish the feasibility and identify the potential advantages and limitations of home-based~     diagnosis of OSA in a high-risk urban African-American population including veterans with~     frequently limited access to healthcare.~      Hypothesis: The investigators hypothesize that home-based PM is not inferior to standard~     laboratory-based PSG in effectively diagnosing OSA in urban African Americans.~   "
119932|NCT01997710|"~     Tooth loss can be addressed by different rehabilitative strategies. Implant-supported crowns~     and conventional bridges (fixed dental prostheses [FDPs]) are well established treatment~     alternatives. Implant therapy is sometimes impossible, however, because of patient-related~     risk factors or economic issues. In such cases therapy with an FDP requires extensive removal~     of tooth structure to provide enough space for the restoration and to ensure mechanical~     retention if the abutment teeth are sound. Alternatives for rehabilitation requiring minor or~     no preparation of the anchoring teeth are desirable. Resin-bonded bridges meet this demand~     for minimal invasiveness and have been used clinically successfully. Sometimes, however,~     patients choose a conventional FDP over a resin-bonded one (RBFDP) for esthetic reasons since~     the adhesive wings, which are traditionally made of a cobalt-chromium alloy, might be exposed~     while speaking or smiling or account for a colour change of the abutment teeth. Such patients~     profit from an all-ceramic RBFDP. Today, the clinical performance of different all-ceramic~     RBFDP designs has not yet been evaluated under randomized controlled conditions. The aim of~     this pilot study is to calculate the sample size that allows us to accept the hypothesis that~     the two designs tested are similar regarding their clinical performance with adequate~     statistical power.~   "
119974|NCT01997164|"~     The primary objective of the study is to investigate the safety and tolerability of~     intravitreal (IVT) REGN910-3 and IVT REGN910 in patients with neovascular age-related macular~     degeneration (AMD), and separately in patients with diabetic macular edema (DME).~   "
121837|NCT01972737|"~     The purpose of this study is to determine the safety, tolerability and ability to stimulate~     hGCC-specific antibody and killer T cell immune responses of an Ad5-hGCC-PADRE vaccine in~     stage I and stage II Caucasian and African American colon cancer patients.~   "
119935|NCT01997671|"~     OBJECTIVE: To evaluate the impact of an intervention addressed to health professionals to~     improve the adequacy of lipid-lowering prescription in primary prevention of cardiovascular~     disease and reducing expenditure in this respect.~      DESIGN: a cluster randomized clinical trial, not blind; Data were obtained from medical~     records and other primary care databases.~      SETTING: 279 primary health care teams in Catalonia (Spain), centers managed by Catalan~     Health Institute (ICS)~      SUBJECTS: Population from 35 to 74 years, free of cardiovascular disease, who have been~     started on lipid-lowering therapy during 2 consecutive years of study.~      INTERVENTION: Practitioners in the intervention group may have access, whenever they want and~     through the computerized medical record program, to personalized information on their~     assigned patients who have started treatment of cardiovascular primary prevention with~     lipid-lowering. This information is updated monthly for 12 consecutive months.Information~     will be presented in two different and complementary ways to each practitioner: asynchronous~     information (the patient is not present when the practitioner receives the information) and~     synchronous information (the patient is present when the practitioner receives the~     information).~      VARIABLES:~        1. Primary Outcomes are:~             -  Variable RETIRA: new lipid-lowering treatments initiated during the year prior to~               the intervention, seen as inadequate and withdrawn during the intervention period.~             -  Variable EVITA: New lipid-lowering treatments started during the intervention~               period and considered as inadequate.~        2. Secondary Outcomes are:~             -  Variable COST: total cost of the inadequate new lipid-lowering treatments.~             -  Variable RECORD: recording of the cardiovascular risk.~      2.Other variables:~        -  Principal: intervention/control group assignment of health professional.~        -  Patient variables: demographic and clinical.~        -  Professional variables: quality of care indicators.~      STATISTICAL ANALYSIS: Descriptive analysis, agreggated at health professional level, will be~     performed and subsequently multilevel analysis techniques will be used to estimate the effect~     of intervention according to hierarchic data structure and, in particular, patient variables~     effect.~   "
119936|NCT01997658|"~     Background: Reducing postoperative complications remains a dominant challenge for all~     clinicians. By minimizing the incidence of adverse outcomes, health care costs and patient~     recovery can be improved. A number of studies have documented that fewer postoperative~     adverse events occur with the preoperative use of glucocorticoids (GC). Two small manuscripts~     support the use of GC with particular reference to liver resection.~      Major hepatectomy can be associated with numerous adverse outcomes (hemorrhage, bile leak,~     liver failure, wound infection other infectious complications). This rate approaches 54% in~     some trials. Additionally, the liver is responsible for numerous metabolic functions and~     actively participates in the acute phase response via the generation of inflammatory~     mediators and cytokines. Glucocorticoids play an important role in suppressing the~     over-synthesis of pro-inflammatory cytokines and therefore may assist in reducing~     postoperative complications. These pro-inflammatory cytokines recruit leukocytes at the site~     of injury, leading to hepatic parenchymal cell damage. Decreasing pro-inflammatory cytokine~     ratio may therefore reduce hepatic damage.~      Methods: The investigators will complete a randomized controlled trial evaluating the~     incidence of postoperative complications and overall hospital length of stay in adult~     patients following preoperative vs. no administration of 500 mg of methylprednisolone (MP)~     within 30 minutes of starting a hepatectomy. This trial will employ block randomization and~     intention to treat protocols. Four HPB surgeons at University of Calgary will participate in~     the trial with a planned inclusion of all patients scheduled to undergo hepatectomy in a~     period of 2 years.~      Analysis: Standard statistical analysis will include normally or near-normally distributed~     variables reported as means and non-normally distributed variables as medians. Means will be~     compared using the student's t test and medians using the Mann-Whitney U test. Differences in~     proportions among categorical data will be assessed using Fischer's exact test. A p value <~     0.05 will represent statistical significance for all comparisons.~      Hypothesis: Preoperative GC administration will decrease the incidence of postoperative~     complications and overall hospital length of stay following hepatectomy.~      Potential Impact: Health care utilization and economics are an expanding area of importance.~     Reducing post-hepatectomy complications are crucial to this end.~   "
119937|NCT01997645|"~     Perianal fistula is a chronic phase of anorectal infection that occurs predominantly in the~     third and fourth decade of life. According to Parks classification fistulas have been divided~     into intersphincteric, transsphincteric, suprasphincteric and extrasphincteric. Simple~     fistulotomy can be performed with satisfactory outcomes in low fistula tracts but in high~     (transsphincteric) fistulas it may affect anal continence seriously.~      Therefore sphincter preserving procedures should be preferred in these cases. Rectal~     advancement mucosal flap (RAF) is one of the methods used in surgical fistula eradication~     with high success rate in cryptoglandular fistulas. However, this technique is technically~     demanding and results can be expert depended with wide spread of healing rates (24-100%) in~     individual studies as referred in recent systematic review.~      Ligation of the intersphincteric fistula tract (LIFT) has been presented in 2007 as a simple~     sphincter preserving technique. The success rate varies between 40-95% with low overall~     incontinence rate (6%).~      The aim of the study is to compare the efficacy of the LIFT and RAF procedure for treatment~     of high perianal fistulas.~   "
119938|NCT01997632|"~     The purpose of this study is to investigate if the study vaccine, m-IPV2 HD (vaccine that~     only contains polio serotype 2 in high dose), is as safe as the standard IPV Imovax (that~     contains the 3 serotypes of polio). This safety evaluation will be done in young adults.~      If the study vaccine appears to be safe, it will be tested at a later stage in the target~     group (infants and children) to evaluate the immunogenicity of the vaccine. After all, the~     purpose is to use the study vaccine in the future to protect young children against Polio~     serotype 2. Disease with Polio type 2 indeed recently re-appeared, so vaccination of young~     children to come to a complete eradication of Polio is needed. The standard use of Imovax to~     protect against Polio serotype 2 would be too expensive. Therefore, a monovalent Polio~     vaccine containing only serotype 2 (= the vaccine that will be evaluated in this study), has~     been developed.~      The duration of the study will be approximately 6 months. 120 subjects between 18 and 45~     years of age will participate in Belgium.~      During the study there will be 2 groups of subjects. Subjects will be assigned by chance to~     one of these groups. One group will receive one single injection of the study vaccine m-IPV2~     HD (which contains only serotype 2), the other group will receive one single injection of the~     standard polio vaccine IPV, Imovax (which contains the 3 serotypes).~      After this vaccination, there will be a follow-up period of 6 months. Subjects will be asked~     to come to the study centre one more time for the second visit (on Day 8, which is 7 days~     after the first visit). They will also receive 2 follow-up phone calls for approximately one~     month and 6 months after vaccination.~   "
119939|NCT01997619|"~     Complex ventral hernia repair is a significant surgical challenge with high frequencies of~     both wound complications and recurrence. The Ventral Hernia Working Group (VHWG) described in~     2010 recommendations regarding grading and technique of repair, which we have followed since~     November 2011.The purpose of the this study was to evaluate our results after biologic mesh~     repair of complex hernias.~   "
119975|NCT01997151|"~     This program of research tested the effectiveness of an iPad delivered multiple behavior~     intervention grounded in the Transtheoretical Model of Behavior Change for pregnant women. It~     was hypothesized that the intervention would reduce the number of health behavior risks~     reported by pregnant women in the treatment group. The target behaviors of the intervention~     are smoking cessation and relapse prevention, stress management, and fruit and vegetable~     consumption.~   "
119976|NCT01997138|"~     This project investigates the relation between acute pain and local inflammation. Pain~     reported by the patients for knee arthroscopy are compared with local changes in inflammatory~     mediators by using microdialysis technique. Patients with moderate-to-severe pain are~     included in a randomized placebo-controlled trial of anakinra given intra-articularly.~   "
119940|NCT01997606|"~     Product information:~      Purotex is a textile treatment that uses five 100% natural bacteria or probiotics, selected~     for their ability to clean up house dust mite allergen along with other allergen types.~      Study design:~        -  Placebo-controlled: the effect of the Purotex impregnated mattress and pillow covers~          will be compared to untreated, classical bedding covers (placebo).~        -  Cross-over design: There will be 2 'treatment' arms. One arm (Arm 1) in which the~          subjects will first use the Purotex impregnated covers (Set A=Purotex) during 2 months~          (=period A) and, after a wash out period of 1 month, the untreated covers (set~          B=placebo) during 2 months (=period B). In the second arm (Arm 2), the subjects will~          first use the untreated set (set A=placebo) and, after a wash out period the Purotex~          impregnated covers (set B=Purotex).~        -  Randomized: The subjects will be randomly assigned to one of the 2 treatment arms.~        -  Double blind: both the subjects and the investigators will not know to which treatment~          arm the subjects are assigned.~      Study hypothesis:~      We want to investigate:~        -  if there is a reduced concentration of HDM allergen in Purotex covers compared to~          untreated covers in real life~        -  if patients with allergic rhinitis to house dust mite use the Purotex covers, they~          experience an improvement of their quality of life and sleep, and an improvement of~          their allergic symptoms and global discomfort~   "
119941|NCT01997593|"~     The aim of this study was to evaluate the analgesic effect of intraperitoneal infiltration of~     ropivacaine in children undergoing laparoscopic surgery.~   "
119942|NCT01997580|"~     To explore electrophysiologic parameters and biomarkers predicting treatment response of~     patients with major depressive disorder To explore electrophysiologic parameters and~     biomarkers predicting suicide risk of patients with major depressive disorder~   "
119943|NCT01997567|"~     The goal of the study is to evaluate via a prospective, blinded, randomized clinical trial,~     whether ultrasound-guided single femoral and lateral femoral cutaneous nerve blocks with~     ropivacaine 0.5% with epinephrine (1:200,000) as a tracer for intravascular injection (total~     30 ml) vs. saline with epinephrine (1:200,000) (total 30 ml), given just prior to same day~     elective hip arthroscopy, is effective in reducing acute postoperative pain (NRS scores),~     postoperative opiate consumption, and time to discharge from the postanesthesia care unit.~     Differences between groups with respect to postoperative quality of life and functional~     scores will also be evaluated.~   "
119944|NCT01997554|"~     The aim of this research project, which is realised with the partnership of the enterprise~     Siamed'Xpress (Marseille), is to validate a new TSH diagnostic test in vitro, to allow an~     earlier screening of hypothyroidism. A serum bank will be conserved in the Centre de~     Biologie Sud (Groupement Hospitalier Lyon Sud).~      The serum samples will be assayed locally for the usual medical support to patients and after~     they will be sent to Siamed'Xpress (Marseille), where they will be assayed with the new~     diagnostic test. The results obtained from the two techniques will be compared.~      The validation of this new TSH test represents a major advancement, since it could bring in~     the future to a therapeutic index which will allow clinicians to treat earlier asymptomatic~     patients with subclinical hypothyroidism.~   "
119945|NCT01997541|"~     There will be a difference of the insertion depth between the types of the endotracheal tube.~   "
119946|NCT01997528|"~     Oxygenatuion and decarboxylation during different settings (steps of blood flow and sweep gas~     flow) of extracorporeal gas exchange by ILA Activve using a jugular 22French double lumen~     cannula are measured.~   "
119947|NCT01997515|"~     Laparoscopic surgery for gastric reduction is frequently associated with high levels of~     postoperative pain. Postoperative pain is very often treated with opioids. However large~     doses of opioids can result in respiratory depression with hypoxemia especially in high risk~     patients with obstructive sleep apnea. since a large group of patients undergoing surgery for~     gastric reduction surgery also have obstructive sleep apnea, it is expected that these~     patients are also at high risk for postoperative respiratory depression and hypoxemia.~      Intraoperative ketamine has been used as an effective multimodal agent to reduce~     postoperative pain. However, ketamine alone has not been examined to improve postoperative~     pain outcomes in patients undergoing gastric reduction surgery. More importantly, it is~     unknown if the use of intraoperative ketamine can lead to better overall quality of recovery~     in the same patient population. In addition, ketamine has been shown to improve ventilation~     but it remains to be determined if the intraoperative use of ketamine will result in less~     postoperative hypoxemic events.~      The main objective of the current investigation is to examine the effect of intraoperative~     ketamine on postoperative quality of recovery after gastric reduction surgery. The~     investigators hypothesize that subjects receiving ketamine will have a greater global quality~     of recovery score than the ones receiving saline. The investigators also seek to determine if~     intraoperative ketamine would decrease the incidence of postoperative hypoxemic events in the~     same patient population.~   "
119948|NCT01997502|"~     This protocol is a request from Masimo to assist in the collection of data to be used to~     further refine the accuracy of the monitor's algorithm.~   "
119949|NCT01997489|"~     Fabry disease is a recessively inherited disorder due to systemic storage of abnormal~     metabolites (ceramide trihexocide, in particular) caused by lack of the lysosomal enzyme~     α-galactosidase. Though X-linked, in patient series there are often equal numbers of males~     (hemizygotes ) and females (heterozygotes, probably caused by a mutation in one allele and an~     inactivation on the other allele in the X chromosomes), and many clinical features are~     shared.~      Abnormal storage in endothelial and smooth muscle cells explains morbidity, including a~     shortened life expectancy. This is due to age dependent ischaemic manifestations that affect~     heart, kidney and brain. Angiofibroma is an early cutaneous manifestation, and painful~     acro-paresthesias express juvenile neuropathy.~      Cornea verticillata is an almost obligate ophthalmic finding. The brown-yellow Bowman~     membrane related corneal deposits and teleangiectatic conjunctival vessels are early~     ophthalmic slit-lamp markers of the disorder; further there can be subtle lens opacities.~     Fundus vessel tortuosity is observed in many patients, in particular of the retinal venules,~     but best corrected visual acuity (BCVA) is usually normal.~      After the introduction of enzyme substitution therapy in 2001, ophthalmic examinations were~     scheduled as regular part of the general evaluation of the Fabry patients at Rigshospitalet,~     Denmark. A 10-year ophthalmic state of arts was part of oral presentations at a Copenhagen~     conference in December 2011. In contrast to the common occurrence of systemic vascular~     sequels, only one patient in the series had suffered severe visual loss; this was unilateral~     and occurred years before institution of the enzyme therapy. In 2013, however, another young~     male presented a similar retinal event. Sporadic cases of visual loss are reported in the~     literature, but in larger Fabry series ocular vascular catastrophes appear the exception to~     the rule.~      Following the introduction of enzyme substitution, we found it of interest to present our~     nationwide Danish experience. We focused on retinal vessel morphology and the relation to~     systemic morbidity.~   "
119950|NCT01997476|"~     The purpose of this study is, to develop a standard of care protocol using the combination of~     EUS, ePFT, and sEUS during one endoscopic session (instead of the three separate endoscopic~     sessions). The desired outcome is to diagnose CP and to establish an acceptable protocol for~     performing this combined technique. It is expected that combining these procedures will~     eliminate redundant portions of the procedures, reduce repeat visits to the hospital, reduce~     total recovery time for the patient, and will decrease the associated costs of separate~     procedures. Chronic pancreatitis (CP) is an irreversible, disease in which the pancreas~     becomes fibrotic ( thickened and scarred). Symptoms almost always include pain, and as the~     pancreas becomes progressively more fibrosed (thickened), pancreatic hormonal function is~     compromised with diarrhea and weight loss. However, while most physicians can readily~     diagnose patients with severe CP, early CP or minimal-change CP is difficult to detect,~     often due to the lack of radiologic findings, laboratory tests and classic symptoms. As a~     result, clinicians are searching for diagnostic tools which will allow for earlier, accurate~     detection of this disease, with the hope that appropriate therapy can be initiated before~     extensive thickening and scarring of the pancreas occurs.~      Diagnostic tools to evaluate the pancreas include Endoscopic Ultrasound (EUS),~     hormone-stimulated endoscopic pancreatic function tests (ePFT) and Secretin stimulated~     Endoscopic Pancreas Function Test (sPFT) using pancreatic fluid (containing bicarbonate)~     obtained from the duodenum (the part of the intestine where the stomach opens into the small~     bowel). EUS is increasingly being used as a diagnostic and treatment tool in pancreatic~     disease. Currently, hormone-stimulated ePFT is considered the best way to diagnose chronic~     pancreatitis (long-lasting inflammation and scarring of the pancreas), and removes the need~     for biopsy or surgery. It is also sensitive in detecting mild disease.~      These procedures are standard of care (the normal care you would receive) for the evaluation~     of CP. The purpose of this study, is to develop a standard of care protocol using the~     combination of EUS, ePFT, and sEUS during one endoscopic session, instead of three separate~     endoscopic procedures.~   "
119951|NCT01997463|"~     The investigators hypothesize that school-based, direct supervision of daily controller~     therapy will result in more effective asthma control, as assessed by the Asthma Control~     Questionnaire than usual care. Additionally, as the result of enhanced asthma control and~     resulting decrease in health care utilization, school-based, direct supervision of daily~     controller therapy will result in lower cost per quality-adjusted life year (QALY) gained~     than usual care.~   "
119952|NCT01997450|"~     This is a post-marketing case-controlled study of the effectiveness of a quadrivalent live~     attenuated influenza vaccine (Q/LAIV/FluMist® Quadrivalent) versus Inactivated Influenza~     Vaccine (IIV) and No Vaccine in subjects 2-17 years of age.~   "
119953|NCT01997437|"~     The proposed protocol will involve the replacement of the trachea using a synthetic~     bioengineered scaffold seeded with autologous mononuclear cells as an intraoperative solution~     for patients with with benign and malignant laryngo-tracheal diseases or other terminal~     conditions of the trachea.~      Tracheal transplant is indicated as the only therapeutic alternative in cases where~     instrumental, endoscopic and other evaluations show that the length of residual healthy~     airways (about 6 cm or longer than 50% of the airway length) and the localization and~     extension of the obstruction make it impossible to perform a surgical resection of the~     pathological segment.~      In addition to tracheal surgical transplant techniques, this protocol requires knowledge and~     experience with autologous cell preparation as well as scaffold seeding procedures.~   "
119954|NCT01997424|"~     This study will evaluate the association of non-alcoholic fatty liver disease and diabetes~     mellitus. Patients presenting in our clinic with Diabetes mellitus type 1 or 2 will receive~     the following examination:~        -  Transient Elastography and Controlled Attenuation Parameter using the FibroScan~        -  blood examination including biochemical markers The statistically calculated sample size~          needed is 340 patients.~   "
119955|NCT01997411|"~     The purpose of this study was to assess how glucagon administered as a puff into the nose~     (AMG504-1) works in children and adolescents compared with commercially-available glucagon~     given by injection. In addition, the safety and tolerability of glucagon given as a puff into~     the nose was evaluated.~   "
119956|NCT01997398|"~     There is a growing trend in functional neurosurgery toward direct anatomical targeting for~     deep brain stimulation (DBS). This study describes a method and reports the initial~     experience placing DBS electrodes under general anesthesia without the use of microelectrode~     recordings (MER), using a portable head CT scanner to verify accuracy intra-operatively.~   "
119957|NCT01997385|"~     The aim of this study is to assess the impact of adapted Automated Peritoneal Dialysis(APD)~     sequentially prescribed shorter and longer dwell exchanges with smaller and larger fill~     volumes in comparison with conventional APD prescribed a standard continuous cycling~     peritoneal dialysis on the efficacy of dialysis.~   "
119958|NCT01997372|"~     Severe acquired aplastic anaemia (SAA) is a life-threatening disease characterized by~     pancytopenia and hypoplastic bone marrow. Immunosuppressive treatment with antithymocyte~     globulin (ATG)and cyclosporine remain the standard regimen with response rates of 70% or more~     and excellent overall survival. However ,there are no clinical trials to illustrate the~     response and complete remission rate with different doses of ATG.And there are no data~     reported on children with SAA so far.~   "
119959|NCT01997359|"~     The availability of HIV care and treatment programs is increasing in sub-Saharan Africa.~     However more than half the patients who need HIV treatment are still not receiving~     antiretroviral therapy (ART). This can lead to early death from AIDS. Additionally, many~     patients start ART late after the HIV disease is very advanced. This results in high death~     rates soon after starting ART. The factors that contribute to late ART initiation are still~     unclear. This study will identify factors that help patients to enroll or prevent them from~     enrolling into HIV care and starting ART on time. We will examine the characteristics of all~     patients initiating ART at study sites. We will also look at potential risk factors among~     patients who initiate ART late (cases) compared to patients who initiate earlier (controls)~     at 6 HIV care and treatment clinics in Ethiopia. Data will be collected using 2 methods:~        1. Face-to-face interviews with participants using questionnaires~        2. Obtaining clinical data from the electronic patient-level database~      Identifying factors that help patients to start or prevent them from starting ART on time~     will help to direct interventions, programs and policies to reduce early death.~   "
119977|NCT01997125|"~     The purpose of this clinical study is to allow the investigation of the Neural Bridging~     System for participants with tetraplegia to assess if the investigational device can~     reanimate a paralyzed limb under voluntary control by the participant's thoughts.~   "
119978|NCT01997112|"~     The purpose of this study is to examine if chronic paracetamol dosing increases blood~     pressure in patients with known high blood pressure.~   "
119979|NCT01997099|"~     The purpose of this study is to describe the home healthcare organization ambulatory infusion~     pump programming workflow and the process that was followed to introduce the new CADD®-Solis~     VIP System to each home healthcare organization or facility. In addition, this study will~     characterize the overall clinician (Phase 1) and patient (Phase 2) ease of use and~     satisfaction with the CADD®-Solis VIP System.~   "
119960|NCT01997346|"~     The availability of HIV care and treatment programs is increasing in sub-Saharan Africa.~     However more than half the patients who need HIV medicines are still not receiving this~     antiretroviral therapy (ART), and this can lead to early death from AIDS. One of the problems~     in this region is that patients start ART late, after the HIV disease is very advanced. This~     results in high death rates soon after ART initiation. The way clinic-level factors, such as~     the way services and referrals are organized, how referrals are regarded, counseling messages~     and record-keeping, contribute to late ART initiation is unclear. As the second phase of a~     3-phase NIH-sponsored project, this study will identify clinic-level enablers and barriers to~     timely enrollment into HIV care and ART initiation. A cross-sectional qualitative study will~     be conducted at 4 selected HIV care and treatment clinics and the health facilities in which~     they are located in Ethiopia. Data will be collected using 4 methods:~        1. Data abstraction~        2. Key informant interviews with clinic personnel~        3. Observation of post-test counseling sessions in the VCT clinic~        4. Observation of provider-patient interactions in the care and treatment clinic~          Identifying modiﬁable health facility-level predictors of late ART initiation will~          facilitate implementation of interventions, programs and policies that will increase the~          number of patients who enroll in HIV care and initiate ART early. Additionally, results~          will inform the design of the third phase of the NIH-project referenced above.~   "
119961|NCT01997333|"~     The main purpose of this study is to see whether CDX-011 (glembatumumab vedotin, an~     antibody-drug conjugate) is effective in treating patients who have advanced Triple-Negative~     Breast Cancer (TNBC), and whose tumor cells make a protein called glycoprotein NMB (gpNMB),~     which CDX-011 binds to. The study will also further characterize the safety of CDX-011~     treatment in this patient population.~   "
119962|NCT01997320|"~     Three months intervention study, investigating the effect of nutrient supplementation~     (including 20g of milk protein) twice daily with or without additional heavy resistance~     exercise three times weekly on muscle size, structure and function in 30 subjects at least 83~     years of age.~      Primary hypothesis is that the group conducting exercise improves muscle size, structure and~     function.~   "
119963|NCT01997307|"~     The Ladies ACS study will investigate the relation between age at menopause and severity of~     coronary artery disease in menopausal women with acute coronary syndromes and clinical~     indication to coronary angiography.~   "
119964|NCT01997294|"~     Statins have been approved to benefit patients underwent percutaneous coronary intervention~     (PCI). The current study is designed to evaluate the effectiveness and safety of Sequential~     Therapy of Atorvastatin in patients with ST-elevated myocardial infarction and receive PCI~     treatment.~   "
119965|NCT01997281|"~     The aim of this study is to assess whether dietary fiber-enriched cereals effect on~     postprandial glucose levels and plasma glucagon-like peptide 1 (GLP-1) and/or~     glucose-dependent insulinotropic polypeptide (GIP) concentration in patients with type 2~     diabetes mellitus.~   "
119966|NCT01997268|"~     The purpose of this study is to investigate the effects of SC401B (ethyl esters of~     eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA] 2 (~1260 mg EPA+DHA), 4 (~2520 mg~     EPA+DHA) or 6 (~3780 mg EPA+DHA) capsules per day in subjects with hypertriglyceridemia~     (triglyceride [TG] ≥500 mg/dL and ≤ 2,000 mg/dL). SC401B capsules also contain certain~     surfactants that may aid in the absorption of EPA and DHA. Based on the results of~     pharmacokinetic studies of healthy human subjects, unlike Lovaza®, EPA and DHA in SC401B are~     bioavailable in both the fasted and fed states.~      The protocol specified primary endpoint is the difference from the placebo group in the~     percent change in TG concentration from baseline to week 12 for groups receiving 2, 4, or 6~     capsules of SC401B per day. The protocol specified secondary endpoints include percent~     changes from baseline to week 12 for total cholesterol (TC), LDL-cholesterol (LDL-C),~     HDL-cholesterol (HDL-C), and non-HDL-cholesterol (non-HDL-C). Additional exploratory~     variables include VLDL-cholesterol (VLDL-C), LDL-cholesterol particle size, apolipoprotein~     (Apo) A1, Apo B, Apo C-III, and lipoprotein-associated phospholipase A2 (Lp-PLA2).~      An additional objective is to determine the tolerability and safety of SC401B 2, 4 and 6~     capsules per day for 12 weeks. Adverse events for SC401B and placebo including burping, fishy~     taste, upset stomach, loose stools, stools with fishy smell or any other self-reported~     observations will be evaluated. Additional safety measures will include changes in liver~     enzymes (AST/ALT) occurring from baseline to week 12 for groups receiving 2, 4, and 6~     capsules of SC401B and placebo.~   "
119967|NCT01997255|"~     Sturge Weber Syndrome (SWS) is a rare disease that affects the patient's brain and causes~     benign (non-cancerous) tumors to grow in the brain. One of the symptoms of SWS is epilepsy.~     People with epilepsy have seizures. Some patients may also have eye problems and a red mark~     on their facial skin.~      This study is being done to find out if the study drug, everolimus, is safe and has helpful~     effects in patients with SWS who have seizures and are not responding to their current~     anti-epileptic medication.~      The study drug, everolimus (Afinitor®), is supplied by Novartis Pharmaceuticals Corporation.~   "
119968|NCT01997242|"~     The SAS registry will include any patient with previous coronary stenting undergoing any type~     of surgery or operative endoscopic/endovascular procedure at the participating Centers. The~     relevant clinical, procedural and outcome data (within index surgical admission and at 30~     days) will be entered in a specifically designed electronic case record form (eCRF).~   "
119969|NCT01997229|"~     The purpose of this study is to determine if eculizumab is safe and effective for the~     treatment of refractory generalized Myasthenia Gravis.~   "
119970|NCT01997216|"~     The purpose of this study was to compare binocular high contrast, high illumination (HC/HI)~     visual acuity at near (40 centimeters) of new multifocal contact lenses against AIR OPTIX®~     AQUA MULTIFOCAL contact lenses when worn for 9 hours.~   "
119971|NCT01997203|"~     Treatment of hepatitis C virus (HCV) infection was carried out using pegylated interferon~     (PEG-IFN), ribavirin (RBV) and vitamin D (vit D) for 48 weeks in HCV genotypes 4a subjects.~     The purpose of this study is to determine the effect of vitamin D on liver affection in such~     patients.~   "
119972|NCT01997190|"~     This is a phase I study of intrapleural AdV-tk therapy in patients with malignant pleural~     effusion (MPE). The primary objective is to test the safety of intrapleural AdV-tk therapy.~     Secondary objectives are to evaluate clinical efficacy and biologic activity~   "
119973|NCT01997177|"~     Aim: To study the basic technical skills of colonoscopy using a MS Kinect for motion~     analysis. In order to develop a non-biased tool to monitor competence.~   "
119982|NCT01997060|"~     In Denmark and the western world, there is an increasing prevalence of obesity probably due~     to a combination of inadequate daily physical activity and a high energy intake. One approach~     to achieve weight loss and change life style is to participate in an intensive supervised~     prolonged life style modification course. The immediate effect is often positive, but over~     time the overall effect is limited as the majority will not maintain weight loss and a~     changed life style.~      The purpose of this study is therefore to characterize the physiological factors that~     determine/influence the capacity to maintain weight loss and a healthy lifestyle after a~     prolonged lifestyle intervention.~      We have the following research questions:~        1. Are there physiological traits and characteristics that mediate better adherence to~          lifestyle changes and weight loss?~        2. Does the adaptation in muscle oxidative capacity after lifestyle intervention predict~          success in maintaining weight loss and lifestyle changes 3, 12 and 39 months after~          intervention?~        3. How does gender and age influence the capacity to maintain the lifestyle induced~          adaptation in muscle and adipose tissue and maintaining weight loss?~      The study design is a longitudinal intervention and will be based on a lifestyle~     intervention, as it is practiced in a real life setting at Ubberup folk high school.~   "
119983|NCT01997047|"~     Pneumonia is the commonest cause of death in children worldwide, killing 1.5 million children~     under the age of 5 years, every year. This is more than the number of children dying from~     AIDS, malaria and tuberculosis combined. The current diagnostic and management protocols for~     managing serious respiratory diseases in children are 30 years old and are greatly in need of~     updating. The successful establishment of useful clinical management criteria for children~     with respiratory diseases will have benefits for children in low resource regions around the~     world. The goals of the study are:~        -  To determine if children with respiratory distress can be reliably diagnosed under~          low-resource conditions.~        -  To identify the clinical tests that best differentiate pneumonia from wheezy diseases.~          These will be used to establish updated diagnostic criteria for common pediatric lung~          diseases that broaden the current pneumonia algorithm by adding another for wheezy~          illnesses.~        -  The ultimate objective is to improve the management and outcome of acute respiratory~          conditions in children.~        -  Investigators also wish to test the efficacy of a locally developed cell phone oximeter~          probe in a low resource setting.~   "
119984|NCT01997034|"~     In Denmark and the western world, there is an increasing prevalence of obesity probably due~     to a combination of inadequate daily physical activity and a high energy intake. One approach~     to achieve weight loss and change life style is to participate in an intensive supervised~     prolonged life style modification course. The immediate effect is often positive, but over~     time the overall effect is limited as the majority will not maintain weight loss and a~     changed life style.~      The purpose of this study is therefore to characterize the physiological factors that~     determine/influence the capacity to maintain weight loss and a healthy lifestyle after a~     prolonged lifestyle intervention.~      The investigators have the following research questions:~        1. Are there physiological traits and characteristics that mediate better adherence to~          lifestyle changes and weight loss?~        2. Does the adaptation in muscle oxidative capacity after lifestyle intervention predict~          success in maintaining weight loss and lifestyle changes?~        3. How does gender and age influence the capacity to maintain the lifestyle induced~          adaptation in muscle and adipose tissue and maintaining weight loss?~      The study design is cross-sectional and will be based on a lifestyle intervention, as it is~     practiced in a real life setting at Ubberup folk high school. The investigators will recruit~     former participants of this lifestyle style intervention. 50 % who maintained a weight loss~     and a healthy life style and 50 % who did not.~   "
119985|NCT01997021|"~     Increasing physical activity in older adults has important implications for treating obesity~     related metabolic conditions, however the interaction of aging- and obesity-related declines~     in physical function may make adding structured exercise particularly challenging for this~     group. Given these challenges, an alternative prescription to traditional structured~     exercise, may be short bouts of intermittent walking scattered throughout the day - this may~     be an effective strategy to increase physical activity, reduce sedentary behavior, and~     improve glycemic control in overweight/obese older adults. The purpose of this project is to~     determine how interrupting sedentary time with short bouts of moderate intensity walking~     affects important metabolic outcomes in older, overweight adults. It would also be of~     interest to compare the effects of short, frequent interruptions in sedentary behavior to a~     traditional exercise prescription (continuous 30 min walking bout) on metabolic outcomes~     (e.g., glycemic control, insulin sensitivity, and 24 h fat oxidation). Thus, the overall aims~     of the proposed research are to 1) Determine the effect of performing short bouts of~     moderate-intensity intermittent walking (IW) on glucose and insulin metabolism compared to~     uninterrupted sitting (US) in older overweight and obese adults. 2) To compare the effects of~     interrupting sedentary time (IW) vs. a traditional exercise prescription (continuous 30 m~     walk (CW)) on metabolism.~      The investigators hypothesize that interrupting sedentary time with intermittent walking will~     improve glucose and insulin metabolism compared to uninterrupted sitting and it will be as~     effective at improving metabolism as a single continuous 30 min walk.~   "
119986|NCT01997008|"~     This is a feasibility/pilot test of a set of positive affect skills provided online to HIV~     positive people with elevated depressive symptoms - a Center for Epidemiological Studies~     Depression Scale D (CES-D) score > 10. The investigators will test the feasibility of~     recruitment, retention and acceptability of these skills in an online delivery format,~     determine feasibility and acceptability of daily emotion assessments via text messaging and~     assess efficacy of these skills for improving psychological well-being this population.~   "
119997|NCT01996865|"~     Follicular lymphoma (FL), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL) are~     distinct histologic types of B-cell NHL. Lenalidomide is an immunomodulatory agent with~     direct and immune-mediated mechanisms of action, as well as clinical activity in NHL. Recent~     studies in frontline and relapsed/refractory NHL show high activity for lenalidomide plus~     rituximab (R2), supporting further study of this combination.~   "
120107|NCT01995422|"~     The main objective of this study is to evaluate the effect of a 12 weeks adapted physical~     activity program (active walking) on depression by analyzing the dynamics of emotional and~     cognitive functioning. The secondary objectives are to test the effects of a physical~     activity on functional performance and to highlight psychological mechanisms.~   "
119987|NCT01996995|"~     In a sham controlled double-blind trial we aim to establish the efficacy and safety of local~     application of laser therapy in patients with diabetes with onychomycosis and risk factors~     for diabetes related foot complications. Onychomycosis leads to thickened and distorted~     nails, which in turn leads to increased local pressure. The combination of onychomycosis and~     neuropathy or peripheral arterial disease (PAD) increases the risk of developing diabetes~     related foot complications. Usual care for high-risk patients with diabetes and onychomycosis~     is completely symptomatic with frequent skiving and clipping of the nails. No effective~     curative local therapies exist and systemic agents are often withheld due to concerns for~     side effects and interactions.~      Aim: The primary aim is to evaluate the efficacy of 4 sessions N-YAG 1064nM laser application~     on the one-year clinical and microbiological cure rate in a randomised, double-blinded~     sham-controlled design with blinded outcome assessment.~      Study population: Patients with diabetes mellitus, with an increased risk for diabetic foot~     ulcers.~      Intervention: local laser treatment from a podiatrist and the other group receives treatment~     according to a control procedure. The laser procedure will be performed as a sham procedure~     by a second podiatrist.~      Main study parameters/endpoints: The effect of 4 sessions of laser therapy on cure rate~     (clinical and microbiological) after one year.~   "
119988|NCT01996982|"~     This is a descriptive, nonrandomized, noninvasive, single-group, single-center pilot study of~     a Core Cooling System (CCS) device for reducing core body temperature in ICU patients at~     University Medical Center Brackenridge (UMCB) and Seton Medical Center Austin (SMCA). The~     proposed research on human subjects will provide data that will be used to improve a~     specialized human heat transfer technique/device. By stimulating specialized blood vessels~     (arteriovenous anastomoses) AVAs in the palm of the hand, it is possible to greatly increase~     local blood flow and thus greatly increase the potential for effective heat transfer between~     the environment and body.~      The hypothesis of this trial is that the Core Cooling System (CCS) will prove to be a~     practical, safe, and effective method to raise or lower body temperature in critically ill~     patients.~   "
119989|NCT01996969|"~     Regorafenib is a valuable treatment option for metastatic colorectal cancer patients who have~     progressed after prior standard treatments. Prior progression-free survival data suggest that~     there could be a distinct subgroup of patients that may benefit from regorafenib. The aim of~     this study is to identify predictive biomarker of regorafenib in terms of its efficacy.~   "
119990|NCT01996956|"~     The purpose of this study is to evaluate the ability of fluid responsiveness by stroke volume~     variation value of NICOM(Noninvasive cardiac output monitor)system during congenital cardiac~     surgery.~   "
119991|NCT01996943|"~     Atrial fibrillation (AF) is the most common sustained arrhythmia in the United States and it~     has been associated with ethanol use. Understanding how ethanol affects the electrical~     properties of the heart and induces AF has important public health implications. The~     objective of this research is to investigate the mechanistic relationship between ethanol and~     atrial fibrillation in humans by performing a placebo controlled study looking at the~     electrical properties of the heart in patients receiving intravenous ethanol or placebo. The~     investigators hypothesize that ethanol increases the susceptibility of human myocardium to~     atrial fibrillation through electrophysiologic changes in the atrial myocardium in the acute~     setting.~   "
119992|NCT01996930|"~     Kidney failure is a devastating illness requiring treatment with dialysis or transplantation~     to preserve life. Individuals unable to have transplants are managed by peritoneal dialysis~     (PD)or haemodialysis (HD). PD involves the placement of a soft, flexible plastic tube~     (catheter) into the abdomen, allowing dialysis fluid to be drained in and out of the~     peritoneal cavity. This catheter exits from a hole in the abdomen and occasionally patients~     can have complications at this exit site. One possible complication is over-granulation.~     Over-granulation occurs as the wound attempts to heal and the skin around the exit site~     becomes red,'wet','bumpy' and stands 'proud' of the surrounding skin. An over-granulating~     exit site can lead to discomfort, pain, bleeding and harbour infection. More serious~     complications include dialysis failure, sepsis and death. There are several ways to treat~     over-granulation but there is limited research evidence to demonstrate which treatment is~     best. The study aims to compare current standard treatment which involves the application of~     silver nitrate by qualified nursing staff to chemically burn the tissue away, with an~     alternative treatment which involves the application of steroid impregnated tape to the area~     of over-granulating tissue by the patient themselves.~   "
119993|NCT01996917|"~     This is a prospective, randomized, controlled, single-blinded study to compare Prineo™ with~     subcuticular sutures in 20 women undergoing bilateral breast reduction. For each patient, the~     final skin layer of one breast will be closed with subcuticular suture while the other breast~     will be closed with Prineo™. The treatment will be randomized to left or right breast.~     Therefore, the investigators will have 20 breasts in the suture group and 20 in the Prineo™~     group, with each patient serving as her own control. For this study, the resident will close~     one side with suture and Dr. Rohde will apply the Prineo. The investigators will perform this~     study of incision closure under conditions as similar to normal conditions of closure.~   "
119994|NCT01996904|"~     The purpose of this study was to report actual percentage of subscapularis tear in~     concomitant with supraspinatus tendon tear (with or without infraspinatus tear) and~     investigate the amount of contribution of subscapularis repair as to the outcome of whole~     rotator cuff repair in terms of its clinical and radiologic aspects.~   "
119995|NCT01996891|"~     The purpose of this study is to evaluate the effects of a diet that is low in glycemic load~     and abundant in fiber, fruits, vegetables, legumes and omega-3 fatty acids~     (anti-inflammatory diet) on pulmonary function in pediatric patients with asthma. The~     primary endpoint will be change in forced expiratory volume in one second in response to the~     diet intervention. Secondary outcomes will include additional spirometry measures, fraction~     of exhaled nitric oxide, and assessment of symptomatic asthma control. In addition, we will~     identify potential physiological mechanisms relating diet with lung function, including~     changes in systemic inflammation, insulin sensitivity, and intestinal microbiome composition.~   "
119996|NCT01996878|"~     To observe and analyze the correlation between Single Nucleotide polymorphisms (SNPs) and the~     incidence of Parkinson's disease in Taiwanese.~   "
119998|NCT01996852|"~     This is a research study of erectile dysfunction (ED) in men diagnosed with prostate cancer.~     144 patients and partners will participate in the study. The purpose of this study is to test~     a new treatment that combines a cognitive-behavioral intervention with medication and a~     vacuum constrictive device to treat ED. This new treatment consists of multiple therapeutic~     elements that enhance compliance with medical treatment and increase sexual activity through~     enhancement of the sensual pleasure of sex and partner support.~   "
119999|NCT01996839|"~     The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate~     ophthalmic gel~   "
120000|NCT01996826|"~     The goal of this study is to investigate whether using bevacizumab (Avastin®) is both safe~     and effective at decreasing the likelihood of a high-risk corneal graft rejection. Patients~     who are high-risk for rejection have blood vessels growing from the white of the eye into~     the cornea (clear, front region of the eye). The medication is used at the time of surgery~     and in the weeks following surgery. Participants have a 50/50 chance at receiving the active~     study medication or a placebo medication.~   "
120001|NCT01996813|"~     Shoulder arthroscopy is one of the most commonly performed orthopaedic procedures and it is~     often done with the patient in the upright, or beach chair position (BCP).~      There have been multiple reported complications associated with the BCP, including cerebral~     ischemia, loss of vision, ophthalmoplegia, stroke, and even death. It has been reported that~     patients with a body mass index (BMI) of 34 or greater are as much as 12 times more likely to~     experience cerebral desaturation events (CDEs) compared to non-obese patients. CDEs in the~     upright position are hypothesized to be partially related to reduced cardiac preload due to~     venous pooling in the lower extremities which is exaggerated in obese patients. This~     prospective observational study aims to determine if the use of compression stockings in~     obese patients undergoing shoulder arthroscopy in the BCP can reduce the incidence,~     frequency, or magnitude of CDEs experienced by the patient. We predict that compression hose~     will help to reduce cerebral desaturation events.~   "
120002|NCT01996800|"~     This study explores the effectiveness of chiropractic and neuromuscular reeducation as~     complementary and alternative medicine treatment approaches for autism. Our investigation~     maintains the following three hypotheses:~        1. Spinal manipulative therapy (SMT) will reduce the presentation of autistic symptoms in~          children.~        2. Spinal manipulative therapy (SMT) in conjunction with neuromuscular reeducation will~          reduce the presentation of autistic symptoms in children.~        3. The presentation of autistic symptoms in children will significantly differ between the~          treatment groups of spinal manipulative therapy and spinal manipulative therapy in~          unification with neuromuscular reeducation.~   "
120003|NCT01996787|"~     The purpose of this study was to investigate the safety and efficacy of the Sauflon Clariti~     Monthly silicone hydrogel contact lenses with handling tint (Sauflon Pharmaceuticals Limited)~     by comparison with Air Optix Aqua silicone hydrogel lenses (Alcon Inc.)~      Subjects used OptiFree Replenish solution (Alcon Lboratories Inc.) for daily lens~     maintenance, care and storage.~   "
120004|NCT01996774|"~     Many authors propose the strict avoidance of allergenic food as the only treatment for~     children known to be allergic to certain food. However, it has been observed an increase of~     the frequency and severity of the allergic accidents in these children in the long term.~     Other teams have suggested treating these allergies (in particular peanut allergies) by~     controlled and progressive reintroduction of the allergenic food. A good tolerance and a~     prevention of allergic reactions consecutive to the ingestion of the same allergenic food~     were observed. The immunological mechanisms of this type of treatment are not well known.~      A decrease of specific IgE and an increase of IgG4 have been observed in the case of egg~     allergies after this kind of treatment. Certain experiments realized in mice models testing~     the allergenic stimulation challenge showed an increase of lymphocytes T regulators (foxp3+ ,~     CD4+, CD25+), stimulated by dendritic cells, and also an increase of interleukin 10, leading~     to the modification of the balance between Th1 and Th2.Our hypothesis is that after treating~     allergies by the reintroduction of the allergenic food, the immunological mechanism of~     acquisition of tolerance is associated to variations in populations of lymphocytes and in the~     activation or decrease of pro and anti-inflammatory cytokines. This reaction will be studied~     in two groups: 1. Children with a confirmed allergy to peanuts or nuts and 2. Children~     without antecedents of allergy or familiar atopy.~   "
120005|NCT01996761|"~     This study, E-COMPASS is a phase IV clinical trial designed as a multicenter, randomized,~     double-blind, placebo-controlled, parallel-group study. This study will enroll 75 subacute~     stroke patients with unilateral motor dysfunction. Primary objective is to demonstrate the~     efficacy of porcine brain peptide to improve motor recovery measured by the improvement ratio~     of Fugl-Meyer assessment ((score of FMA after 3 weeks - score of FMA at baseline) / score of~     FMA at baseline) in patients with subacute stroke.~   "
120006|NCT01996748|"~     The purpose of this study is to evaluate the safety and efficacy of DF277 for the treatment~     of otic eczema.~   "
120007|NCT01996735|"~     Preclinical studies have shown that the P2Y12 receptor antagonist ticagrelor can increase the~     extracellular concentration of the endogenous nucleoside adenosine by inhibiting the cellular~     uptake of adenosine via the equilibrative nucleoside transporter (ENT). This mechanism can~     contribute to the beneficial effects and to the side effects (dyspnea) of ticagrelor in~     patients with an acute myocardial infarction. In the current research proposal, we aim to~     investigate whether ticagrelor increases adenosine receptor stimulation in humans in vivo by~     ENT inhibition.~   "
120008|NCT01996709|"~     The purpose of this study is to assess improvement of palpebral roughness and associated~     symptoms with 3 months use of Clear Care®.~   "
120033|NCT01996384|"~     The investigators research project is a randomized, controlled, single-blinded, feasibility~     pilot study. The investigators will study the feasibility of a novel treatment for women with~     Provoked Localized Vulvodynia (PLV) with acupuncture and 5% lidocaine cream. Lidocaine is a~     numbing agent and common first treatment for this disorder. Acupuncture is a treatment~     commonly used for other pain disorders. The investigators will compare two types of~     acupuncture (classical and non-classical) as a treatment for PLV, in addition to 5% lidocaine~     cream. Researchers want to determine if acupuncture is acceptable and convenient to women~     with PLV. The investigators hypothesize that classical acupuncture and 5% lidocaine cream~     will be better than non-classical acupuncture and 5% lidocaine cream to decrease PLV pain.~   "
120009|NCT01996696|"~     In current clinical practice, an acceptable standard treatment for locally advanced prostate~     cancer is radiation therapy in combination with hormone therapy (called Treatment B or Group~     B in this study). However, despite our best treatments, there is a risk that the prostate~     cancer may eventually return. As well, the hormonal therapy that is given to treat the~     prostate cancer is known to cause some harmful effects, with some patients using the hormones~     gaining weight, developing diabetes, having increased cholesterol levels, having increased~     blood pressure, and/or heart problems.~      This study is looking at whether Metformin, a drug that is commonly used to treat diabetes,~     can prevent patients from developing some of the harmful effects of the hormonal therapy. In~     treating diabetes, Metformin is known to decrease patients' sugar levels and also prevents~     patients from gaining weight, decreases their cholesterol levels, decreases the number of~     heart problems and allows patients to live longer. As a result, the researchers in this study~     are hopeful that Metformin will also be beneficial for men with prostate cancer on hormonal~     therapy by preventing them from developing these problems.~   "
120010|NCT01996683|"~     safety and efficacy of different iron chelation therapy in transfusion dependent~     beta-thalaasemia patients with low serum ferritin and continued regular transfusion regimen.~   "
120011|NCT01996670|"~     We hypothesis a period of early NCPAP before surfactant treatment is effective for treating~     RDS and preventing BPD in very premature infants.~   "
120012|NCT01996657|"~     The optimal intensity of oral anticoagulation in China patients undergoing mechanical valve~     replacements is still controversial due to the different risk profiles of thrombophilia and~     bleeding in Chinese patients. Elevated D-dimer could reflect a pro-thrombogenic or~     prothrombotic state, and thus might be used to decide the intensity of oral anticoagulation.~      This study was to evaluate whether elevated D-dimer levels could help to determine the~     intensity of oral anticoagulation in patients with mechanical heart valve prostheses.~   "
120013|NCT01996644|"~     This is a pilot study investigating if cycloserine (DCS; a learning enhancement medication)~     augments exposure therapy for food anxiety in patients with anorexia and bulimia nervosa. The~     investigators expect that (a) exposure therapy will reduce anxiety (b) anxiety will be~     reduced more in the DCS relative to placebo condition (c) participants in the DCS condition~     will have a greater increase in Body Mass Index.~   "
120014|NCT01996631|"~     Oxidative stress(OS), inflammation, and endocrine-disrupting chemicals(EDC) were all thought~     as important markers that will impact on female reproductive function. However, the~     cause-result correlations between above parameters were still unclear. Investigator plans to~     design a study to evaluate the OS, inflammation, and EDC and their impact on the menstrual~     cycle and reproductive hormone in Taiwanese women. Ferritin is a ubiquitous intracellular~     protein that is essential for the regulation of iron homeostasis. Serum ferritin level is a~     widely available clinical biomarker used to estimate body iron status. Iron is a strong~     pro-oxidant, and high body iron levels are associated with an increased level of OS that may~     elevate the risk of type 2 diabetes. Mildly elevated body iron stores are associated with~     statistically significant elevations in glucose homeostasis indexes. Furthermore, patients~     with elevated iron stores present not only insulin resistance but also metabolic alterations~     that put them at increased risk of cardiovascular disease. Increased serum ferritin levels~     have been found in women with Polycystic Ovary Syndrome(PCOS). Serum ferritin were highly~     correlated with menstrual cycle and androgens level in women. Homocysteine, a~     sulfur-containing amino acid formed during the metabolism of methionine, exerts cytotoxic~     effects on the vascular endothelium. Hyperhomocysteinemia has been established as an~     independent risk factor for thrombosis and cardiovascular disease, and it may partially~     account for the increased risk of cardiovascular disease associated with insulin resistance.~     Elevated total plasma homocysteine levels have been established as an independent risk factor~     for thrombosis and cardiovascular disease. Studies related to homocysteine and PCOS have~     reported inconsistent results.~      Chronic low-grade inflammation has emerged as a key contributor to the pathogenesis of PCOS~     and obesity. A dietary trigger such as glucose is capable of inciting OS and an inflammatory~     response from mononuclear cells of women with PCOS, and this phenomenon is independent of~     obesity. The correlation between inflammatory markers and reproductive endocrine disturbance~     and consequent complications should be important.Both OS and EDC had been associated with~     PCOS.~      BPA, one of EDC, is an environmental estrogen used in the synthesis of plastics, is a~     high-volume production chemical with widespread human exposure. BPA was been reported in~     several female reproductive disturbance. However, the pathological pathway of BPA impact on~     female reproductive system had not been well-understood. Reactive oxygen species have a role~     in the modulation of gamete quality and gamete interaction. Persistent and elevated~     generation of ROS leads to a disturbance of redox potential that in turn causes OS. The first~     part of our study is aim to evaluate the OS impact on the biochemical parameters in women~     with PCOS; the secondary part of our study is to investigate the BPA on the clinical and~     biochemical of women with PCOS; finally, investigator plans to test the hypothesis that BPA~     might increase OS and then elevated ROS in women with menstrual disturbance, furthermore, the~     role of OS and BPA impact on insulin resistance and metabolic disturbance will be also~     investigated.~      OS, inflammation, and EDCs are all important factors impact on the reproductive competence in~     women. To clarify above problems are critical importance. Investigator then conduct this~     study to demonstrate those problems. Study and control cases will be included. Serum total~     oxidant status, inflammatory biomarkers, total antioxidant status, BPA, and~     clinical/biochemical parameters will be obtained for all cases. OS and BPA will be evaluated~     with all clinical/biochemical parameters for all subjects.~   "
120015|NCT01996618|"~     Investigate whether ranolazine, a novel anti-anginal agent with antiarrhythmic properties,~     has a role in the management of symptomatic ventricular premature beats.~   "
120016|NCT01996605|"~     The purpose of this study is to determine the effect of intrathecal oxytocin on areas and~     intensity of hyperalgesia and allodynia induced by topical capsaicin.~   "
120017|NCT01996592|"~     Many factors influence the development of persistent pain after CS (chronic pain) as well as~     post-partum depression. We are attempting to use trajectory pain methods in an attempt to~     identify those at risk for the development of persistent pain post delivery using a daily~     method of contact for the determination of pain scores. Assessments are also done evaluating~     satisfaction of pain management and maternal/infant bonding opportunities. Physical activity~     is monitored by subject's wearing a Fitbit with correlation being done with pain scores~     obtained over 60 days postop with eligible subjects..~   "
120018|NCT01996579|"~     Lactoferrin is a protein that is a component of the immune system. It has many properties~     that could make it the ideal agent for the prevention of hospital-acquired infections.~     Lactoferrin has antibacterial properties (is able to kill or stop the growth of disease~     causing bacteria and fungal organisms), it improves immune function, and can increase the~     growth of beneficial bacteria in the bowel. Lactoferrin has been approved by Health Canada as~     a Natural Health product and is sold in health food stores as a supplement. However, given~     the potential beneficial effects of Lactoferrin, it requires further study as to its effects~     in acutely and seriously ill patients. One potential use which has not been studied is for~     the prevention of infections in critically adult ill patients. The aim of this study is to~     determine the utility of Lactoferrin in this patient population.~      The Lactoferrin that the investigators will be using in this study is extracted from cow's~     milk, where it naturally occurs. Cow lactoferrin has similar properties as that normally~     produced in the human body. This study is being conducted to determine how well a solution of~     Lactoferrin given orally and through a feeding tube helps to prevent infections and~     inflammation in critically ill patients in addition to usual care and other measures that are~     known to be partially effective for the prevention of infections.~   "
120019|NCT01996566|"~     Differences in human oral sensitivity for caproic, lauric, oleic, linoleic, and linolenic~     acids will be explored. Prior work indicates that there may be a learning effect in measuring~     detection thresholds for free fatty acids. This study is designed to determine the number of~     visits necessary to attenuate this learning effect and also to test whether this effect~     continues across different types of fatty acids or is specific to each fatty acid. This will~     aid in understanding how many visits are required to obtain reliable data and if less~     expensive fatty acids can be used to attenuate learning before testing thresholds for more~     expensive fatty acids.~   "
120020|NCT01996553|"~     The purpose of this study is to establish the rate of radial artery occlusion post~     transradial cardiac catheterization through different modalities.~      The study hypothesis is that specialized imaging can provide specific information to help~     identify hand complications after cardiac catheterization through the wrist.~   "
120034|NCT01996371|"~     The purpose of this study is to compare the healing of the patients spine at 24-months~     following surgery and screw placement among 3 groups. The doctor will also compare clinical~     outcomes and the immediate and delayed medical and surgical complications among the 3 study~     groups. The goal of this study is to determine if treating patients with one of the 3 groups~     is better than the others.~   "
120035|NCT01996358|"~     Succinylcholine is commonly used for neuromuscular relaxation for short procedures such as~     rigid bronchoscopy. A more modern alternative is the application aof rocuronium, reversed by~     sugammadex. The investigators compare the intubating conditions, incidence of postoperative~     myalgia (POM) as well as patient satisfaction for these two muscle relaxants.~   "
121838|NCT01972724|"~     The purpose of this study is to evaluate the efficacy of pioglitazone 30 mg on glycemic~     control as when used in patients with inadequately controlled type 2 diabetes mellitus~     treated with fixed combinations of metformin and sulfonylurea.~   "
120021|NCT01996540|"~     Title: The role of early systematic best palliative care versus on request palliative care~     consultation during standard oncologic treatment for patients with advanced gastric or~     pancreatic cancers: a randomized, controlled, multicenter trial.~      Description of Study Treatment:~        1. Interventional arm Patients will receive standard oncologic care and will be assigned to~          early systematic best palliative care. They will meet a member of the palliative care~          team within 2 weeks after enrolment. Thereafter, they shall be visited by a palliative~          care team member every 2 weeks until death. Patients assigned to this experimental arm~          will be evaluated if the total of palliative care visits between T0 (day of enrollment)~          and T1 (12±3 weeks) is ≥3. Palliative care visits and intervention has to be oriented by~          the General guidelines for palliative care: specific attention will be paid to assessing~          physical and psychosocial symptoms, establishing goals of care, assisting decision~          making regarding treatment, and coordinating care on the basis of the individual needs~          of the patients.~           The doctor expert in palliative care, with regular visits in the experimental arm, must~          be a physician dedicated full time to palliative care, that can directly prescribe drugs~          and other interventions, and with a particular attention to physical, psychological, and~          spiritual needs.~           Palliative care doctor must have the possibility to decide about organizational~          arrangements.~           He has to perform the palliative care visit according to Temel indications.~        2. Standard arm Patients will receive standard oncologic care and will be assigned to on~          request palliative care consultation. They will be not scheduled to meet with the~          palliative care service unless a meeting will be requested by the patients, the family,~          or the oncologist. After the time of evaluation (T1) patients will be followed by the~          palliative care services as needed.~      Patient completes QoL (Quality of Life) and mood questionnaires at baseline and at 12 weeks ±~     3.~      Patients will receive standard antineoplastic treatment in both arms of the study according~     to best clinical practice in each participating centre.~   "
120022|NCT01996527|"~     This pilot clinical trial studies advanced magnetic resonance imaging (MRI) techniques in~     measuring treatment response in patients with high-grade glioma. New diagnostic procedures,~     such as advanced MRI techniques at 3 Tesla, may be more effective than standard MRI in~     measuring treatment response in patients receiving treatment for high-grade gliomas.~   "
120023|NCT01996514|"~     We hypothesized that FA in a TV program watched during a meal, would block satiety responses~     to pre-meal energy consumption and delay satiation in OW/OB but not in NW boys and girls.~     Food intake was measured at 30 min following a glucose (1 g of glucose/kg body weight) or~     sweetened noncaloric beverage with or without the presence of food advertisements. Subjective~     appetite will be measured as well.~   "
120024|NCT01996501|"~     Objective:~      Primary objective of the present study was to compare the single dose bioavailability of~     Torrent's Olanzapine Orally Disintegrating 5 mg Tablets versus Zyprexa® Zydis® 5 mg Tablets~     (Reference formulation; Eli Lilly and Company, USA). Dosing periods were separated by a~     washout period during fed study.~      Study Design:~      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence~     Study~   "
120025|NCT01996488|"~     Objective:~      Primary objective of the present study was to compare the single dose bioavailability of~     Torrent's Olanzapine Orally Disintegrating 5 mg Tablets versus Zyprexa® Zydis® 5 mg Tablets~     (Reference formulation; Eli Lilly and Company, USA). Dosing periods were separated by a~     washout period during fasted study.~      Study Design:~      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence~     Study~   "
120026|NCT01996475|"~     Objective:~      Primary objective of the present study was to compare the single dose bioavailability of~     Torrent's Escitalopram Oxalate Tablet 20 mg [Test formulation, Torrent Pharmaceuticals Ltd.,~     India] Versus Lexapro® (Escitalopram Oxalate Tablet 20 mg) [Reference formulation, Forest~     Laboratories Inc, USA] . Dosing periods were separated by a washout period during fed study.~      Study Design:~      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence~     Study~   "
120027|NCT01996462|"~     Objective:~      Primary objective of the present study was to compare the single dose bioavailability of~     Torrent's Escitalopram Oxalate Tablet 20 mg [Test formulation, Torrent Pharmaceuticals Ltd.,~     India] Versus Lexapro® (Escitalopram Oxalate Tablet 20 mg) [Reference formulation, Forest~     Laboratories Inc, USA] . Dosing periods were separated by a washout period during fasted~     study.~      Study Design:~      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence~     Study~   "
120028|NCT01996449|"~     Hypertensive patients often show an exaggerated rise in blood pressure during exercise~     through overactivity of the exercise pressor reflex. An increasing body of evidence suggests~     a role for aldosterone in augmenting the exercise pressor reflex in hypertensive humans. We~     hypothesize that this effect of aldosterone is mediated by its direct action on the central~     nervous system and that administration of mineralocorticoid receptor antagonists constitute~     an effective treatment for EPR overactivity in hypertension, independent of reductions in~     resting BP.~   "
120029|NCT01996436|"~     The primary objective of the study is to determine the optimal intra-arterial drug treatment~     regimen for arterial lumen restoration post cerebral vasospasm following aneurysmal~     subarachnoid hemorrhage. The secondary objective is to evaluate clinical outcome at 90 days~     post discharge following optimal intra-arterial drug treatment for cerebral vasospasm.~      We hypothesize that Intra-arterial (IA) infusion of a combination of multiple vasodilators is~     more efficacious than single agent treatment cerebral vasospasm therapy.~      All procedures done as a part of this study are standard hospital care procedures done to~     treat cerebral vasospasm and all drugs to be used are FDA approved.~   "
120030|NCT01996423|"~     The purpose of this study is to determine whether oral vitamin D supplementation improves the~     clinical severity of atopic dermatitis in children. In addition, this study plans to evaluate~     the effects of vitamin D supplementation on several key aspects of the immune system of~     children with atopic dermatitis.~   "
120031|NCT01996410|"~     The goal of this study is to determine if acupuncture improves multiple symptoms associated~     with chemotherapy on the MD Anderson Symptom Inventory (MDASI): nausea, vomiting, fatigue,~     anxiety, anorexia, pain, disturbed sleep, shortness of breath, dry mouth, depression, and~     peripheral neuropathy (see statistical section). The investigators hypothesis is that~     acupuncture will result in lower MDASI scores over the course of chemotherapy for the~     acupuncture group vs. control group.~   "
120032|NCT01996397|"~     Exploratory, prospective, interventional, non-randomized single-center research study to~     compare metrics derived from 2 or 3-D reconstructions of lead movement, bioimpedance and VCG~     to augmentation of left ventricular contractility (LV dP/dt max) at different pacing~     configurations in patients undergoing a CRT-implant. Pacing sites and contractility data will~     be compared to pre operative cardiac ultrasound and MRI metrics.~   "
120121|NCT01995240|"~     Novel predictive markers are needed to determine treatment efficacy in pancreatic cancer at~     an early stage. Preferably, these markers could be determined non-invasively and provide~     insight into the biology of pancreatic cancer. Several MR techniques can serve for this~     purpose. However, optimalisation of these techniques is needed and their reproducibility~     should be assessed.~   "
120036|NCT01996345|"~     The purpose of this study is to perform a large multi-center randomized trial comparing the~     role of vaginal pessary versus expectant management in women with placenta previa between~     22w0d and 32w0d of gestation in prolonging gestation until ≥36 weeks. Secondary outcomes will~     assess duration of antepartum admission, total blood loss, gestational age at delivery, type~     of cesarean delivery, and a composite neonatal outcome. The hypothesis is that the use of a~     vaginal pessary in patients presenting with placenta previa between 22-32 weeks will decrease~     delivery prior to 36 weeks as compared to expectantly managing these patients.~   "
120037|NCT01996332|"~     This study will evaluate the efficacy and safety of oral Tarceva in patients with advanced~     NSCLC for whom Tarceva monotherapy is considered the best therapeutic option. The anticipated~     time on study treatment is 3-12 months.~   "
120038|NCT01996319|"~     This study is designed to assess the effect of QVA149 (110/50 ug q.d.) versus placebo on~     pulmonary function and average physical activity levels in patients with moderate to severe~     Chronic Obstructive Pulmonary Disease (COPD).~   "
120039|NCT01996306|"~     The primary purpose of this study is to determine the non-inferiority of overall survival~     XELIRI with or without Bevacizumab compared with FOLFIRI with or without Bevacizumab as~     Second-line therapy in Patient with Metastatic Colorectal Cancer.~   "
120040|NCT01996293|"~     This study seeks to examine how the dose of lamotrigine (Lamictal) should be adjusted during~     pregnancy for women with Bipolar Disorder. The investigators predict that the concentration~     of Lamictal in women's blood will decrease during pregnancy, and increase after postpartum.~     Because the concentration of the medication is likely to decrease during pregnancy, it is~     important for doctors to know how much they should increase a patient's dose in order to~     prevent worsening of Bipolar symptoms. In this study, the investigators will ask that~     participants complete up to five overnight visits to our clinical research unit where their~     blood will be drawn every couple of hours, through an IV catheter, to measure how the~     concentration of lamotrigine (Lamictal) changes over time. Participants will be compensated~     for their time.~   "
120041|NCT01996280|"~     Culturally-tailored empirically-based interventions are needed because Latinos suffer a~     greater burden of alcohol-related health disparities and negative social consequences~     compared to other racial/ethnic groups, are less likely to initiate and to remain in~     treatment, and are more likely to live in communities with a high density of alcohol outlets.~     Pilot data from the PI's (New Investigator) K award (AA014905), which will serve as the basis~     for the current proposed larger-scale study, demonstrated that culturally tailored~     motivational interviewing (CTMI) outperformed motivational interviewing (MI) that was not~     tailored to the needs of Latino heavy drinkers. The public health impact of this study will~     be to develop a program of early screening and brief intervention to reduce hazardous~     drinking among Latinos, to minimize the burden of illness and social consequences that~     disproportionately affect Latino communities.~   "
120042|NCT01996267|"~     This study compares two schedules of upfront chemotherapy in HER positive breast cancer.~   "
120043|NCT01996254|"~     The purpose of this study is to determine if electrical stimulation (small levels of~     electricity) can safely and effectively reduce post-amputation pain. This study involves a~     device called the SPRINT System. The SPRINT System delivers mild electrical stimulation to~     nerves in the residual limb. The SPRINT System includes a small wire (called a lead) that~     is placed through the skin in the upper leg. It also includes a device worn on the body that~     delivers stimulation (called the SPRINT Stimulator).~   "
120044|NCT01996241|"~     This cluster Randomised Control Trial is evaluating an intervention to support adolescent~     girls from marginalised communities in northern Karnataka State, South India to complete~     secondary school, thereby reducing their vulnerability to HIV infection from early marriage~     and entry into sex work at young ages. The intervention will test innovations to address both~     supply and demand side barriers to girls' completion of secondary school, and will have~     long-term educational and livelihood benefits, in addition to reducing vulnerability to HIV.~      School-based constraints will be addressed by improving academic outcomes through teacher~     training and academic support to students; addressing gender-related and skill-based gaps~     among teachers; training of local female teachers; and increasing the content knowledge of~     secondary school teachers. Demand side barriers will be addressed by reducing economic~     pressures that households face to withdraw girls' from school; building appreciation and~     value of girls' education; building family and community accountability for school~     attendance; creating safe spaces for girls and strengthening their agency; and engaging boys~     in promoting and supporting girls' education.~      Primary stakeholders will include teachers and students, especially adolescent girls in the~     school (7th to 10 the standard) from marginalized communities. Secondary stakeholders will~     include school development and management committees (SDMCs), families, boys and the~     communities that are served by the schools. 80 village clusters (40 intervention; 40 control)~     were randomly selected from 125 village clusters in Bagalkot and Bijapur districts. The~     intervention will be implemented with village communities and high schools in 40 village~     clusters in Bagalkot and Bijapur districts. The intervention will be implemented in~     collaboration with the Department of State Educational Research and Training (DSERT),~     Karnataka; the Adolescent Education Cell, Government College of Teachers' Education (CTE),~     Jamkhandi; and the Institute for Advanced Studies in Education (IASE), Gulbarga.~   "
120045|NCT01996228|"~     Type 1 diabetes (T1D) is an autoimmune disease that usually occurs in children and reduces~     their pancreatic islet beta cells and thereby limits insulin production. Millions of~     individuals worldwide have T1D, and the number of children with diagnosed or undiagnosed T1D~     is increasing annually. Insulin supplementation is not a cure. It does not halt the~     persistent autoimmune response, nor can it reliably prevent devastating complications such as~     neuronal and cardiovascular diseases, blindness, and kidney failure. A true cure has proven~     elusive despite intensive research pressure over the past 25 years. Notably, Dr.Zhao and his~     team have successfully developed a groundbreaking technology Stem Cell Educator therapy (Zhao~     Y, et al.BMC Medicine 2011, 2012). To date, clinical trials in adult patients have~     demonstrated the safety and efficacy of Stem Cell Educator therapy for the treatment of T1D~     and other autoimmune-associated diseases. Here, the investigators will evaluate the safety~     and efficacy of Stem Cell Educator therapy in children with type 1 diabetes.~   "
120046|NCT01996215|"~     This study is to determine how cognitive deficits (e.g.,verbal fluency deficit) in patients~     with Age-Related Macular Degeneration (AMD) relate to specific aspects of brain and function.~     The study team will assess whether the brain signatures associated with specific cognitive~     deficits differ in older adults with and without AMD.~   "
120047|NCT01996202|"~     This is a pilot study assessing the safety of the combination of ipilimumab administered~     concurrently with radiotherapy for patients with locally advanced or unresectable melanoma~     and patients at high risk for recurrence after resection.~   "
120048|NCT01996189|"~     The primary objective is to compare the difference in the pain score in radial arterial~     puncture using the insulin needle versus the standard 23G hypodermic needle.~   "
120049|NCT01996176|"~     The purpose of the study is to test an intervention aiming to reduce sitting time during work~     hours among office workers.~      Expectations according to outcome measures: Sitting time reduced by 1 hour pr. day (primary).~     Number of prolonged periods reduced by 1 pr. day (primary). Number of breaks increased by 3~     pr. day (primary). 20 % of participants report a reduction of musculoskeletal pain~     (secondary). A reduction in waist circumference of 1 cm (secondary). A reduction of 0.5 % in~     bodyfat (secondary).~   "
120050|NCT01996163|"~     Postoperative pain is a major concern in routine management of children admitted to pediatric~     intensive care treatment. There are significant negative physiological and psychological~     ramifications of postoperative pain such as impairment of cardiac function due to~     tachycardia, restlessness in an intubated patient requiring increase dosage of sedative and~     paralytic drugs and reduced patient cooperation in the healing process.~      The main body of evidence dealing with gender differences in pain perception and treatment~     stems from studies in the adult and adolescent population as the gonadal hormones have a~     central role in the way one experiences pain The hypothesis of this study is that there is a~     difference in the perception of pain, the amount of analgesia used and the response to pain~     medication between male and female infants undergoing craniosynostosis repair or untethering~     of cord.~   "
120051|NCT01996150|"~     This is pilot, mechanistic study to address whether bleach baths given to adult subjects with~     atopic dermatitis or eczema, who are colonized with the bacteria Staphylococcus aureus, will~     significantly alter their skin microbiome and in so doing improve their skin barrier,~     diminish expression of inflammatory proteins in the skin and improve itch. To answer these~     questions the investigators will perform a 3-month, pilot, investigator-initiated,~     single-center, open-label clinical study. This study will allow us to test the following~     hypothesis: 1) that bleach baths will normalize skin barrier function, 2) that bleach baths~     will diminish the local inflammatory response in the skin, and 3) that bleach baths will~     improve validated measures of itch (also called pruritus).~   "
120052|NCT01996137|"~     An exploratory clinical study on a Variable Speed and Sensing Treadmill system(VASST) for~     hemiparetic gait rehabilitation after stroke.~      Building upon the positive results of VASST I conducted in 2012, VASST II will be an open~     label pilot trial of 11 subjects screened for eligibility by TTSH medical and rehabilitation~     team Study hypotheses : Training on VASST may result in a gain of +40% - 50% for distance~     walked and +10-20% of gait speed compared to baseline and response rate of 85% and serious~     adverse event rate of <10%.~   "
120053|NCT01996124|"~     Chronic Obstructive Pulmonary disease (COPD) is one of the major clinical entities that~     causes thousands of deaths every year all over the world and weights a lot on the health care~     system of every country in terms of direct and indirect costs. The physiopathological~     modifications that characterise COPD are represented by irreversible (sometimes partially~     reversible) airflow obstruction, and bronchiolar inflammation. Lungs that develop emphysema~     lack of elastic recoil and imply increased resistances and airflow obstruction due to loss of~     lung parenchyma and supporting elastic structures. All these modifications produce air~     trapping and so lung hyperinflation. The latter is precisely the cause of the symptoms and~     particularly dyspnoea which is often heavily perceived by COPD patients and that drives to~     the limitation of daily activities. Lung hyperinflation and the other alterations that occur~     in COPD imply gas retention and increase in pulmonary vascular resistances. Considering that~     the rib cage has limited elastic properties, the effects of gas trapping and lung parenchymal~     damage on mediastinum and particularly on heart mechanics is indisputable. Together with~     alveolar hypoxia, lung hyperinflation is responsible for the development, as the disease~     progresses, of the cor pulmonale. Tha latter causes pulmonary hypertension and increased~     mechanic load during right heart chambers contraction and relaxation. Those alterations may~     effect left heart chambers too.~      Airflow obstruction in COPD is usually treated by inhaled bronchodilators and~     corticosteroids. The main and most used bronchodilators are represented by beta 2 agonists~     (short, long and ultra-long acting) and anticholinergic inhalatory drugs, which can be also~     short, long and ultra long acting. Among ultra long acting beta 2 agonists, indacaterol is~     characterised by quick onset of action (5 minutes), and guarantees an effective~     bronchodilation duration of 24 hours. It is also known that it has an important effect on~     reducing lung hyperinflation decreasing residual volume and consequently allowing an increase~     of inspiratory capacity. The purpose of our study is to evaluate the effects of indacaterol~     on lung hyperinflation in COPD subjects of any stage and with lung air trapping, and the~     consequent potential effects on heart performance evaluated by cardiac trans thoracic echo~     color doppler.~   "
120054|NCT01996111|"~     This is a prospective, controlled, randomized, blinded and comparative, single-center~     clinical trial comparing the improvement of patients with recalcitrant plantar fasciitis~     symptoms that have received standard of care versus treatment with differing amounts of~     injectable dehydrated human amnion/chorion membrane micrografts(dHACM).~   "
120055|NCT01996098|"~     The purpose of this study is studying icotinib following chemotherapy to see how well it~     works compared to chemotherapy in treating patients with resected stage IIA-IIIA NSCLC~     harboring EGFR mutation.~   "
120056|NCT01996085|"~     Arterial hypertension (AH) is an important clinical social and economic problem. In the~     pathogenesis of AH increased BP is a result of complex mechanisms i. e. fluid retention,~     increased vascular resistance and hyperkinetic heart function. Impedance cardiography (ICG)~     is a simple and safe, non-invasive method of hemodynamic monitoring which allows simultaneous~     assessment of i. e. BP, cardiac index, heart rate, the fluid content in the chest and~     systemic vascular resistance.~      The detailed effect of treatment based on ICG has not been evaluated so far in the long-term~     observation and for other clinically relevant parameters, such as central blood pressure,~     left ventricular hypertrophy, metabolic disturbances, parameters of antioxidative-oxidative~     balance and endothelial function. Therefore, the following main objectives of the study were~     defined:~        -  Evaluation of usefulness of impedance cardiography in optimizing treatment of patients~          with hypertension in the area of reduction and control of blood pressure, hemodynamic~          parameters, biochemical markers and quality of life.~        -  Evaluation of complex pathophysiological mechanisms associated with hypertension~          including hemodynamic, anthropometric, psychological and biochemical parameters as well~          as the effect of antihypertensive treatment on these phenomena.~      The study will be randomized (1:1), prospective and controlled in parallel with conventional~     treatment. The subjects will be divided into groups according to the pre-established random~     order:~        1. empiric group (GE), in which treatment choice will be based on clinical data and current~          guidelines~        2. hemodynamic group (HD), in which treatment choice will be based on clinical data and~          current guidelines considering hemodynamic parameters established with ICG method.~      All patients will undergo a detailed examination three times: before treatment, then after 3~     and 12 months of treatment.~      The authors expect that the study will consolidate the importance of ICG in the diagnosis of~     patients with AH. Simultaneous multiparametric evaluation of the subjects guarantees a unique~     and innovative results which can enhance our knowledge in pathophysiology of AH and~     reversibility of adverse mechanisms associated with this disease.~   "
120088|NCT01995669|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of GA101 (obinutuzumab) and lenalidomide that can be given to patients with~     indolent NHL. The study will also look at how well the two drugs work together to control the~     disease.~      This is an investigational study. Lenalidomide is FDA approved for the treatment of multiple~     myeloma (MM) and myelodysplastic syndrome (MDS). Obinutuzumab is FDA approved and~     commercially available for the treatment of chronic lymphocytic leukemia (CLL). Its use in~     this study is investigational. The combination of lenalidomide and obinutuzumab is~     investigational.~      Up to 72 participants will be enrolled on this study. All will be enrolled at MD Anderson.~   "
121839|NCT01972711|"~     This study is designed to evaluate the effects of a single dose of SEP-363856 in healthy male~     and female volunteers with high or low schizotype characteristics.~   "
120057|NCT01996072|"~     Primary hyperparathyroidism is a significant medical and public health problem in the world~     and affects approximately 100,000 new patients in the United States alone. If left untreated~     this can lead to renal stones, osteoporosis, fatigue, and depression. The best treatment for~     primary hyperparathyroidism is surgical parathyroidectomy. However surgical parathyroidectomy~     can be difficult due to the variant location of the parathyroid glands. Up to 5% of patients~     leave the operating room without surgical cure.~      Primary hyperparathyroidism is an ideal disease to investigate intraoperative fluorescent~     imaging. This would allow surgeons to identify the parathyroid glands and resect the~     suspicious parathyroid glands. Folate receptor (FR) has been found to be over-expressed in~     parathyroid tissue and not thyroid issues. An ideal surgical treatment would combine~     FR-specific fluorescent tracers with intraoperative imaging. It is important to note that FR~     is expressed only in the proximal tubules of the kidneys, activated macrophages, and in the~     choroidal plexus. Thus, the false positive detection rate is expected to be extremely low.~      A group well known to us in the Netherlands has completed a pilot study utilizing a~     folate-FITC conjugate in 12 patients with ovarian cancer. Another group of investigators in~     Mayo have subsequently performed this study on 20 more patients without any serious adverse~     events (personal communication). They report excellent sensitivity and specificity with this~     technique with only grade 1 side effects (allergic reaction). All side effects reversed when~     the injection was halted. Patients with a history of allergic reactions to insect bites~     should not participate (fluorescein is derived from the firefly insect, folate is an~     essential vitamin).~      A fluorescent contrast agent (folate-FITC or EC17) will be used to determine if it will~     localize to the primary tumor nodule(s) or mass(es) of patients undergoing parathyroid~     surgery.~   "
120058|NCT01996059|"~     The purpose of this study is to find out whether the nutritional status of patients~     undergoing Functional Jejunal Interposition is better than those with Roux-en-Y After Total~     Gastrectomy for Gastric Cancer. To find a better reconstruction for patients who received~     total gastrectomy.~   "
120059|NCT01996046|"~     This study will evaluate baseline uptake on a FDG PET/CT scan in patients with breast cancer~     that has spread to the bones. A repeat FDG PET/CT scan will be done 4 weeks after the start~     of new breast cancer hormone treatment and again at 12 weeks after treatment start. The~     baseline uptake and change in uptake after the repeat scans will be compared to clinical long~     term outcomes such as time to progression and overall survival. In addition the uptake will~     be compared to the incidence of skeletal related events that are common occurrences in~     patients with cancer that has spread to the bones.~   "
120060|NCT01996033|"~     The purpose of this observational study is to further evaluate the safety and performance of~     the EnligHTN™ Renal Denervation System in the treatment of patients with uncontrolled~     hypertension in clinical routine practice.~   "
120061|NCT01996020|"~     Transfontanellar Doppler can measure the velocity at both the carotid artery and the anterior~     cerebral artery during cardiopulmonary bypass in congenital heart disease patients. This~     study can provide reference value of appropriate cerebral blood flow velocity during~     pediatric cardiac surgery.~   "
120062|NCT01996007|"~     Pneumococcus is a bacteria that causes disease of the respiratory tract (pneumonia and middle~     ear infections), blood poisoning, and meningitis. It is frequently carried by people in back~     of the throat without symptoms. Pneumococcal carriage in the Thames Valley region has been~     studied over the last 12 years with carriage rates having been shown to be reflective of~     disease potential and hence vaccine effect. During this time pneumococcal vaccines have been~     introduced into the routine immunisation schedules of this community. The PCV7 (A vaccine~     against 7 types of pneumococcus) vaccine has subsequently been noted to have had a~     significant impact in reducing vaccine serotype carriage and disease. Herd protection~     (indirect protection of unvaccinated individuals) has also been implicated with vaccine~     serotypes not being carried in parents of vaccinated children. The most common serotype~     carried since the introduction of PCV7 is 19A, which is included in the PCV13 vaccine (A~     vaccine against 13 types of pneumococcus). PCV13 has superseded PCV7 in the routine~     immunisation schedule, however its impact on carriage and disease in this community is yet to~     be evaluated.~   "
120063|NCT01995994|"~     To assess the accuracy, safety, and influence of sampling site of Real-time continuous~     glucose monitoring system (Medtronic Guardian).~   "
120064|NCT01995981|"~     This study is a phase IV post registration prospective observational feasibility study in~     patients with metastatic soft tissue sarcoma. Pazopanib is the registered treatment for~     patients with advanced soft tissue sarcoma after chemotherapy with doxorubicin or ifosfamide.~        -  This study looks at the possibility of using 18F-2-fluoro-2-deoxy-D-glucose~          fluorodeoxyglucose (FDG) positron emission tomography PET scans as an early biomarker of~          pazopanib treatment effect in patients.~        -  It also studies pazopanib pharmacokinetics to see if there are differences between~          elderly and younger patients.~      The primary objectives are:~        -  To evaluate whether early metabolic response is correlated to clinical benefit.~        -  To evaluate the effect of age (≥ 70 years) on pazopanib pharmacokinetics.~      The secondary objectives are:~        -  To evaluate whether early metabolic response (% decrease in FDG uptake due to pazopanib~          therapy) is correlated with pazopanib exposure.~        -  To evaluate whether early metabolic response (% decrease in FDG uptake due to pazopanib~          therapy) is correlated with the histological subtypes.~   "
120065|NCT01995968|"~     The main objective is to assess the role of antenatal detection of fetal growth restriction~     (FGR) on stillbirth, by a case-control study in a population-based sample of small for~     gestational age (SGA) livebirths and stillbirths in 3 French counties (Isère, Savoie and~     Haute-Savoie). SGA births will be defined as a birthweight below the 10th percentile of~     French customised birth weight curves.~      Our secondary objectives are~        -  to identify determinants of antenatal detection of FGR among a representative sample of~          SGA births, with a special interest in the definition of FGR. Our hypothesis is that~          births who are SGA by customised birthweight curves and non-SGA by population~          birthweight curves, are not detected antenatally, despite the current strategy including~          the use of umbilical Doppler.~        -  to analyse prenatal care of a subsample of SGA stillbirths with and without detection of~          FGR by a confidential enquiry.~   "
120066|NCT01995955|"~     The proposed study is to validate a new non-invasive imaging technique for evaluation of~     cardiac microciculation in coronary artery disease with a comparison with validated technique~     invasive, which is measure of index of myocardial resistance.~   "
120067|NCT01995942|"~     Extramural venous invasion (EMVI) is the spread of microscopic tumour cells into the veins~     around the tumour. Rectal cancer treatment has improved greatly over recent years. However,~     it is important for us to learn as much about the tumours as possible in order to develop~     newer therapies. Current treatments may benefit from new genetic information relating to the~     cancer. We hope to identify genetic differences in certain types of rectal cancer which will~     allow future treatments.~   "
120068|NCT01995929|"~     The esophago-gastro-duodenoscopy is an endoscopic examination technique of the upper GI-tract~     which was founded by the German surgeon Johann Freiherr von Mikuliicz-Radecki at the end of~     19th century. By this means, the luminal site of the esophagus, stomach and duodenum may be~     visualized after inserting a flexible endoscope through the mouth (transoral access). By the~     rapid technical development in the last years smaller flexible video endoscopes have been~     developed allowing also an alternative access to the upper GI-tract via the nose (transnasal~     access).~      Patients with dysphagia are referred to physicians of different disciplines~     (gastroenterology, surgery, ear, nose, and throat (ENT) medicine, radiology, neurology)~     performing a variety of endoscopic and non-endoscopic techniques. Mostly, the endoscopic~     examination of the esophagus is done in sedated patients in left lateral examination. Typical~     findings during esophagoscopy might be tumors, strictures, achalasia or diverticula.~      Patients suffering from neurogenic dysphagia often get caught in the trap: they find~     themselves somewhere in the space between gastroenterologist, neurologist, ENT-specialist and~     radiologist. This dilemma might be due to a lack of pathophysiological knowledge among many~     physicians and an inability to directly visualize the esophageal phase of deglutition. In~     sedated patients lying in left lateral position, endoscopists may receive a very limited~     impression of the function of the different phases of swallowing since this endoscopic access~     is a rather static one.~      The focus of our observational study are patients with suspected neurogenic dysphagia. These~     patients shall be examined by transnasal endoscopy applying an ultrathin video endoscope with~     an outer diameter of 3.8 mm (BF-3C160, Olympus Europe). Patients are examined in sitting~     position while ingesting water and food of different consistencies (functional endoscopy).~     Diagnostic shall be completed and correlated by videofluoroscopy, high-resolution manometry~     and assessment of the clinical signs. Beside feasibility and safety as primary endpoints,~     secondary endpoints shall be the assessment of pathologic endoscopic findings in patients~     suffering from neurogenic dysphagia. The study is approved by the local Ethics Committee (AZ~     2010-214-f-S).~   "
120069|NCT01995916|"~     This study has been funded by National Institute of Mental Health (NIMH) to compare two~     behavioral interventions for Menstrual Mood Disorders, including premenstrual dysphoric~     disorder (PMDD). Both of these interventions will be run in a group format, meaning that you~     will be part of a group of other women who have a menstrual mood disorder. Both of these~     interventions will be run by experienced mental health professionals and both interventions~     have been shown to be effective in reducing mood symptoms, increasing a sense of well-being,~     and helping individuals cope with stress. While it is expected that both interventions to be~     associated with some benefit, this study is designed to see which is better for women with a~     menstrual mood disorder.~   "
120070|NCT01995903|"~     To combine several brain imaging techniques to develop a new diagnostic test to help with~     earlier diagnosis of amyotrophic lateral sclerosis.~   "
120071|NCT01995890|"~     The Nevanac product information insert says that it can cause increase in eye pressure in~     5-10% of patients. There is very little published literature on the effect of topical~     Nepafenac eye drops on eye pressure in normal people. The purpose of our study is to report~     this effect with a working hypothesis that there is no increase in eye pressure following use~     of Nepafenac eye drops.~   "
120072|NCT01995877|"~     To determine if laying down or standing up changes the diameter of the inferior vena cava.~   "
120073|NCT01995864|"~     The study represents the research component of a broader initiative entitled RedeAmericas.~     RedeAmericas (RA) is a collaborative effort of investigators from six cities across Latin~     America (Buenos Aires, Cordoba, Medellin, Neuquen, Rio de Janeiro, and Santiago) and Columbia~     University in New York.~      This is a pilot Randomized Controlled Trial (RCT) of Critical Time Intervention—Task Shifting~     (CTI-TS). It is designed to address a fundamental gap in the services offered by mental~     health clinics. These clinics are the primary locale for outpatient treatment of individuals~     with severe mental disorders in the urban areas of Latin America, and they offer some basic~     and important clinical care such as pharmacologic treatment onsite. Generally these clinics~     also have a major limitation; they have inadequate resources and training for the provision~     of in vivo community-based services, that is, services delivered outside of the clinic~     facility in homes or elsewhere in the community. In most urban areas, they also have weak~     links to primary health care and are not easily accessible to much of the population.~      CTI-TS, is a task shifting intervention that at the service user level provides support for~     better community living and promotes social integration, and at the system level strengthens~     the connections between mental health and primary care clinics. CTI-TS is a time-limited~     9-month intervention provided at the critical time when a person is first offered services at~     a mental health clinic. During this period CTI-TS workers forge relationships that will shape~     the continuing use of services and enhance the potential for recovery over the subsequent~     course of time. The overall goal of CTI-TS is to improve the lives of those with severe~     mental disorders who receive community-based mental health care.~   "
120074|NCT01995851|"~     Overall, this study will determine (1) the effect of vaccine type (FluMist vs. TIV) on~     immunization rates, (2) assess the feasibility of school immunization clinics, and (3) inform~     a larger study to understand the effects of these two vaccines on reducing influenza.~   "
120075|NCT01995838|"~     This is a multicenter, multiple dose, randomized, double-blind, placebo-controlled,~     parallel-group, Bayesian adaptive, dose response study in subjects with chronic insomnia.~     Subjects will be randomized to 1 of 6 doses of E2006 (1 mg, 2.5 mg, 5 mg, 10 mg, 15 mg, or 25~     mg) or placebo.~   "
120076|NCT01995825|"~     In this study, brand name lamotrigine (LAMICTAL) and generic lamotrigine will be compared in~     patients with epilepsy. Both the brand name and generic lamotrigine are approved by the Food~     and Drug Administration (FDA) and are commonly used to treat epilepsy. Some physicians and~     patients with epilepsy have believed that brand and generic lamotrigine have had clinically~     significant differences in efficacy and tolerability. The brand name and generic tablets have~     been shown to be the same when blood levels were measured in healthy volunteers without~     epilepsy, but these drugs have not yet been compared in patients with epilepsy. This study~     will do this comparison, by switching patients between brand and generic in a very structured~     manner, and seeing if the drugs are the same, primarily in terms of blood levels. Other~     comparisons will also be made secondarily, looking for any differences in adverse effects and~     seizure control.~   "
120089|NCT01995656|"~     The main purpose of this study is to evaluate the safety and tolerability of the study drug~     known as LY3108743 in healthy participants and in participants with type 2 diabetes.~      The study will also investigate how LY3108743 affects the levels of blood sugar and other~     naturally occurring substances (e.g. hormones that control the way sugar is used) in the~     body, how much of the study drug gets into the blood stream, and how long it takes the body~     to get rid of it.~      Information about any side effects that may occur will be collected. The study is expected to~     last approximately 7 to 8 weeks for each participant.~      The study will have up to 3 parts. Participants may enroll in only one part.~   "
120077|NCT01995812|"~     Physical activity is an important lifestyle modification for individuals with high blood~     pressure. It is part of national cardiac care guidelines for hypertension management that~     recommends, along with prescribing medication, lifestyle modification be promoted for~     improved dietary intake, and participation in about 150 minutes of moderate exercise a week.~     Native Hawaiians and other Pacific peoples (NHPP) have among the highest risk for the heart~     disease, with mortality rates twice other ethnic groups. In many minority populations,~     including NHPP, hypertension develops at an early age, is more severe and is less likely to~     be controlled. Despite the ability of physical activity to reduce blood pressure, the~     majority of U.S. population, do not meet physical activity recommendations and new~     interventions that can improve accessibility and adherence, particularly among at-risk~     minority populations are needed.~      In this research, Hypertension and Hula: Ola Hou Pilot Study, we plan to evaluate a~     culturally relevant intervention that uses hula and is consistent with the goals of~     recommended physical activity for improved lifestyle - moderate-intensity, prolonged physical~     activity cumulatively at about 150 minutes per week. Hula, the traditional dance form of~     Native Hawaiians, is commonly practiced in Hawai'i as a cultural practice, form of creative~     expression, and exercise that is structured on controlled, rhythmic movements. Combining~     aspects of meditation, music, self-awareness with low-impact aerobic exercise, traditional~     hula may be particularly suitable to individuals with limited mobility and fitness and within~     the recommended paradigm for exercise training and secondary prevention of coronary artery~     disease (CAD). We anticipate a hula and heart health education program will be particularly~     appealing to Native Hawaiians and other Pacific people (NHPP) including Pacific Islanders and~     Filipino who suffer from a significant disparity in cardiovascular health.~      Specifically, we will determine if individuals with poorly managed hypertension and~     randomized to a 12-week hula and heart health education intervention will demonstrate better~     blood pressure levels, functional capacity, and exercise tolerance (6-minute walk test) than~     individuals randomized to a usual care group. We will also assess if the individuals in the~     hula intervention report better health-related quality of life, stress management,~     perceptions of discrimination, and exercise self efficacy.~   "
120078|NCT01995799|"~     Ferumoxytol is an example of a 'smart' magnetic resonance contrast agent that consists of~     ultrasmall superparamagnetic particles of iron oxide (USPIOs) and is avidly taken up by~     macrophages. Through a previous work, the investigators have established that USPIOs can~     identify inflammation in the wall of abdominal aortic aneurysms and that this is associated~     with a three-fold increase in the rate of aneurysm growth. The utility of ferumoxytol for~     imaging cardiovascular inflammation in other areas of the body has yet to be established but~     Dr Alam has established uptake of USPIOs in the penumbra and infarct zone of the myocardium~     in patients with a recent myocardial infarction. The investigators wish to assess USPIO~     uptake in patients with recent acute myocardial infarction and identify the time course and~     determinants of cellular tissue inflammation. This will be the first clinical study to~     examine the ability of USPIOs to image myocardial inflammation following acute myocardial~     infarction.~   "
120079|NCT01995786|"~     The aim of the study is to evaluate clinical and economic impact of Goal Directed Fluid~     Therapy according to NICE haemodynamic protocol. Haemodynamic parameters were assessed using~     automated pulse contour analysis (Flotrac/Vigileo®). A specific dedicated software has been~     developed to perform clinical and expenditures data collection, both retrospective and~     prospective data are archived.~   "
120080|NCT01995773|"~     Polycystic ovary syndrome (PCOS) is a common endocrine disorder in premenopausal women. Women~     with PCOS often have problems with fertility, unwanted hair growth, and irregular menstrual~     cycle. PCOS is associated with obesity, changes in glucose metabolism and low quality of~     life.~      In the present study, hormonal profile, glucose metabolism, adrenal functon, androgen levels,~     cortisol metabolism, anflammatory response, ovarian morphology, body composition, pfysical~     activity and quality of life is studied in 40 healthy women. The results will be compared~     with results from studies on women with PCOS in order to investigate any differences in these~     parametres.~   "
120081|NCT01995760|"~     The purpose of this study is to evaluate which is the most appropriate parameter correlates~     with clinical effectiveness of vancomycin: trough drug level or AUC/MIC.~   "
120082|NCT01995747|"~     Despite the success of Omalizumab that neutralizes free IgE in blood and interstitial fluids,~     treatment of many allergic disorders remains an unmet medical need. Omalizumab was approved~     for patients having serum IgE levels in the range of 30-700 IU/ml. Omalizumab may not be~     effective for patients with much higher serum IgE levels, such as those with atopic~     dermatitis. Therefore, an alternative approach that targets IgE-committed B cells directly~     and inhibits the synthesis of IgE without binding to free IgE will be attractive. Anti-CεmX~     mAb, developed by Dr. TW Chang in Academia Sinica, binds human mIgE+ cells, including~     IgE-committed lymphoblasts and memory B cells. Such anti-CεmX mAbs should be able to activate~     B cell receptor (BCR) signaling, which leads to anergy or apoptosis of mIgE+ B lymphoblasts,~     and induces ADCC through their Fc portion. Depletion of mIgE+ B cells by anti-CεmX treatment~     would inhibit the formation of IgE-producing plasma cells, resulting in a long-term~     attenuation of IgE synthesis that would eventually lead to a desensitized state in allergic~     patients.~   "
120083|NCT01995734|"~     The present study is planned as an expanded treatment protocol to provide acromegalic~     patients for whom medical therapy is appropriate access to pasireotide LAR while regulatory~     approval for pasireotide is sought.~   "
120084|NCT01995721|"~     Recurrent respiratory papillomatosis in children caused by HPV 6,11 can be a life threatening~     condition resulting in surgical interventions. The maturing and disintegrating papillomas are~     the sources for the subsequent HPV relapses and immunization might slow down or even prevent~     this ongoing process.~      After an initial immunological and ear-nose-throat (ENT) assessment children with at least 3~     relapses in their patient history will be vaccinated with 4-valent HPV vaccine according to~     the following schedule: 0., 2., 6. months. It will be followed by an immunological and 3 ENT~     examinations to assess response to vaccination.~   "
120085|NCT01995708|"~     The purpose of this study is to see if the investigator can help the immune system to work~     against myeloma.~      This study will see if a vaccine made with altered dendritic cells will make T cells work~     against tumor cells. The stem cells collected for the transplant will also be used to grow~     dendritic cells in the lab. The dendritic cells will carry the antigens. These cells then~     will be injected under the skin. The investigators will do lab studies before and after the~     vaccination to find out if the vaccine is working.~   "
120086|NCT01995695|"~     H7N9 avian influenza (AI) viruses have caused a recent outbreak of severe respiratory disease~     in humans in China. The purpose of this study is to evaluate the safety and immunogenicity of~     a live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine in healthy adults. A single dose~     of inactivated subvirion H7N9 influenza vaccine will be administered 3 months later.~   "
120087|NCT01995682|"~     The study is to evaluate the feasibility of the NLA tool, a combined assessment of~     nutritional and physical functional status, to provide personalized advice for the~     independence and mobility of elderly.~   "
120092|NCT01995617|"~     GEN-004 is a combination of 3 conserved proteins from Streptococcus pneumoniae. This is a~     randomized, double-blind, placebo-controlled, dose escalation study. Eligible subjects (male~     and non-pregnant female) will be assigned sequentially to 1 of 3 dose cohorts and randomized~     in a 3:1:1 ratio to receive GEN-004 with adjuvant, GEN-004 without adjuvant, or placebo,~     respectively. Each subject will receive up to 3 doses at 4 week intervals.~      Subjects will be followed for safety, tolerability, and immunogenicity for 12 months after~     their last dose.~   "
120093|NCT01995604|"~     The purpose of this study is to evaluate the efficacy of dHACM (Dehydrated Human Amnion~     Chorion Membrane) for reducing time to healing when used in post-laser recovery following~     ActiveFX™ and DeepFx™ fractionated ablative CO2 laser resurfacing of the face.~   "
120094|NCT01995591|"~     Evaluation of the possibility to detect sentinel lymph node(s) after ex vivo Indocyanine~     Green injections around the tumour in pieces of colectomy from patients with colon cancer.~   "
120095|NCT01995578|"~     The purpose of this study is to learn if 5'-Azacitidine will help to lower the risk of the~     disease coming back after a stem cell transplant in patients with MDS and AML. This study~     will also be looking at the side effects of this medicine.~      5'-Azacitidine is an FDA approved drug for treatment of MDS and AML, as well as patients~     whose disease came back after transplant, where it helped going into remission. It is unclear~     if 5'-Azacitidine can prevent the disease from coming back after transplant. This study will~     help show if getting 5'-Azacitidine soon after transplant can lower the risk of your disease~     coming back.~   "
120096|NCT01995565|"~     This prospective investigation studies changes in regional cerebral hemodynamics and~     oxygenation as a function of cardiac output and blood pressure in intensive care patients.~   "
120097|NCT01995552|"~     The purpose of the INSPIRE-ELR study is to characterize arrhythmias in post MI low EF (≤35%)~     patients in the acute phase (at discharge from hospital after index MI) and chronic phase (at~     8-10 weeks after index MI) and to correlate with patients at high risk of all-cause mortality~     or sudden cardiac death (SCD) at 1 year.~   "
120098|NCT01995539|"~     The purpose of the India iPro2 study is to demonstrate that iPro2 Continuous Glucose~     Monitoring System (CGMS) evaluation enables Health Care Professional (HCP)s treating patients~     in India with type 2 diabetes to get a better understanding of their patient's metabolic~     fluctuations, and support appropriate therapeutic intervention.~   "
120099|NCT01995526|"~     The main purpose of this study is to evaluate how the body processes the study drug known as~     insulin peglispro and how the study drug affects blood sugar in healthy male Japanese~     participants. This study will also evaluate safety of the study drug. The study will last up~     to 46 days for each participant, not including screening.~   "
120100|NCT01995513|"~     The purpose of this study is to determine if continued treatment with Enzalutamide is~     effective in patients with metastatic prostate cancer.~   "
120101|NCT01995500|"~     The NIREUS study aims to demonstrate angiographic non-inferiority for the BioNIR~     Ridaforolimus Eluting Coronary Stent System (hereafter referred to as BioNIR) in comparison~     to the Resolute zotarolimus-eluting stent (hereafter referred to as Resolute).~      The trial hypothesis is that the BioNIR is non-inferior to the Resolute for the primary~     endpoint of angiographic in-stent late loss at 6 months.~   "
120102|NCT01995487|"~     The BioNIR study aims to show that the BioNIR ridaforolimus eluting stent is non-inferior to~     the Resolute zotarolimus-eluting stent for the primary clinical endpoint of target lesion~     failure (TLF) at 12 months; that it is non-inferior to the Resolute for the secondary~     endpoint of angiographic in-stent late loss at 13 months; and that it is more cost-effective.~   "
120103|NCT01995474|"~     Endoscopic ultrasound and fine needle aspiration are useful tools for the diagnosis and~     staging of pancreatic cancer. One potential limitation is contamination when needle traverses~     the gastrointestinal tract under continuous negative pressure. Gastrointestinal tract~     contamination can lead to misinterpretation of FNA specimens. We propose a technique to~     eliminate any remaining negative pressure during EUS-FNA and therefore decrease~     gastrointestinal tract contamination. Our hypothesis is that briefly untwisting the syringe~     from the biopsy channel after a specimen is obtained eliminates any remaining negative~     pressure in the FNA needle and therefore reduces GI tract contamination of EUS-FNA specimens,~     and will lead to improved diagnostic accuracy of this important clinical technique.~   "
120104|NCT01995461|"~     The most common forms of injection used for the treatment of degenerative lumbar spinal~     stenosis (DLSS) patients with neurogenic claudication (NC) are the caudal and inter-laminar~     epidural injections of anesthetic and steroid. Unilateral transforaminal epidural steroid~     injections (TESI) are also used to alleviate patients' symptoms of NC from DLSS, particularly~     in patients whose level of stenosis is L4-5 or higher. However, these unilateral injections~     do not cross the midline, so in cases of lower extremity pain and symptoms on both sides, a~     bilateral TESI would probably be more beneficial.~      To date, there have not been any well designed prospective studies to determine the~     effectiveness of bilateral TESI below the level of stenosis in DLSS patients with NC.~     Therefore, the goal of this prospective, non-randomized case-series outcome study is to~     evaluate the effectiveness of BTESI in alleviating symptoms of NC, as well as improving~     function in patients with DLSS. The hypothesis is that BTESI at the level below the most~     stenotic segment of the central canal of the lumbar spine decreases symptoms of NC and~     improves function in patients with DLSS.~   "
120105|NCT01995448|"~     Septic shock is still a major cause of death in ICU. Sepsis diagnosis is linked with many~     clinical, hemodynamic and biological criteria which have a low sensitivity and specificity if~     they are considered separately. The extensive experimental data which have been published~     contrast with the hematological data collected by the physician at patient's bedside~     especially regarding neutrophils and platelets levels. When there is no obvious clinical~     sign, a biological tool reflecting the patient's immune status could be useful to understand~     the physiopathology of Sepsis and to predict the progression of the disease in the patient.~     On the long-term it could also help to define management strategies.~   "
120106|NCT01995435|"~     Correlating the accuracy of a refraction done over telemedicine to that of a standard~     refraction, with a study hypothesis that the results will be equivalent.~   "
122042|NCT01970046|"~     SP2086 is a new dipeptidy1 peptidase(DPP)-4 inhibitors. This study aims to evaluate the~     efficacy and safety of SP2086 in combination therapy with Metformin in patients with Type 2~     Diabetes Mellitus in Metformin monotherapy Who Have Inadequate Glycemic Control~   "
120108|NCT01995409|"~     Exposure to second-hand smoke during pregnancy and early infancy leads to low birth weight~     and childhood illnesses. 50% of all newborns in the UK are exposed to tobacco smoke due to~     maternal smoking or contact with second-hand smoke.~      The purpose of this study is to test the feasibility of delivering and evaluating the~     effectiveness of a Smoke Free Homes (SFH) health education intervention with pregnant women~     and mothers with newborns to reduce unborn and newborn babies exposure to second-hand smoke.~     The intervention will be delivered through routine antenatal and postnatal healthcare~     settings provided by midwifery and health visiting services.~      The intervention consists of educational materials to be given to the woman and a~     conversation held between the woman and midwife/health visitor about protecting the baby from~     second-hand smoke. The development of the intervention has been informed by the views of~     health professionals and service users, incorporates behaviour change theory and has drawn on~     other SFH materials developed for other settings. Different parts of the intervention will be~     delivered at different points along the antenatal and postnatal care pathway. 200 pregnant~     women and their newborns will be recruited.~      We will measure salivary cotinine levels to assess the level of exposure to SHS in women and~     urinary cotinine levels in newborns. We plan to conduct a before-and-after study of the~     delivery of the intervention to test the feasibility of delivering, and methods to evaluate~     the effectiveness of the intervention.~      Feasibility study outputs:~        -  A standardised, acceptable, feasible and appropriate health education intervention to~          protect unborn and newborn babies exposure to second-hand smoke at home, capable of~          being integrated into routine midwifery and health visiting practice~        -  A trial protocol to evaluate the effectiveness of the intervention on unborn and newborn~          babies' exposure to secondhand smoke.~   "
120109|NCT01995396|"~     In patients with rectal cancer, an anterior resection with a colo-rectal or colo-anal~     anastomoses is the gold standard. However, in patients with a weak sphincter and fecal~     incontinence or in patients with severe co-morbidity and reduced general condition, this~     operation is not suitable.~      In these situations there are two other radical surgical options, Hartmanns procedure and the~     Abdominoperineal excision that can be performed with intersphincteric dissection to minimise~     perineal complications.There are no data on which of these procedures that are best suited~     for these patients with fecal incontinence or severe co-morbidity( at risk for~     life-threatening anastomotic leak). In this randomized study we intend to compare~     postoperative complications within 30 days after these two procedures and also late~     complications and quality of life after one year postoperatively.~   "
120110|NCT01995383|"~     This single-center, randomized, placebo-controlled, double-blind study will assess the~     safety, pharmacokinetics and pharmacodynamics of RO6836191 in healthy male volunteers in two~     parts. Part 1 will assess the safety of oral single ascending doses of RO6836191 compared to~     placebo in fasted volunteers. In Part 2, participants will be given two single oral doses of~     RO6836191 or placebo under low or normal-salt diet conditions. A subset of these participants~     will subsequently receive a single IV dose of RO6836191 for further analysis.~   "
120111|NCT01995370|"~     To examine the efficacy and safety of dual antiplatelet therapy (DAPT) including cilostazol~     (Pletaal OD Tablet ®) in comparison with antiplatelet monotherapy (excluding cilostazol) for~     secondary prevention of ischemic stroke in high-risk patients for stroke~   "
120112|NCT01995357|"~     The influence of the baseplate adhesive type, shape and application is investigated with~     regard to the degree of leakage.~   "
120113|NCT01995344|"~     This is a two arm, open-labelled phase II randomised trial of Tumour Infiltrating Lymphocytes~     (TIL) in metastatic melanoma patients given with preconditioning chemotherapy and~     Interleukin-2 (IL2). Eligible patients will undergo surgical tumour excision from which TIL~     will be derived, cultured and expanded. Patients will receive preconditioning chemotherapy~     with cyclophosphamide (60mg/kg) day -7 and day -6, followed by fludarabine (25mg/m2) day -5~     to day -1. The autologous TILs will be re-infused on day 0 and the patients will receive up~     to 12 doses of intravenous High Dose Interleukin-2 (HD-IL2) or Low Dose Interleukin-2~     (LD-IL2) depending on the randomised arm.~      The primary objectives are response rate assessed and compared by CT scans carried out at~     week 6, week 12 and at 12 weekly intervals thereafter and the evaluation of feasibility and~     tolerability of TIL therapy with HD-IL2 versus LD-IL2.~   "
120114|NCT01995331|"~     Severe aplastic anemia (SAA)is characterized by the depletion of hematopoietic precursors~     associated with life-threatening complications. High-dose cyclophosphamide has been found to~     yield a complete response (CR) in adults and children with SAA.However, the optimal dosage of~     cyclophosphamide for patients in childhood remains unclear. So we explore the ideal dosage of~     cyclophosphamide for the treatment of children with SAA.~   "
120115|NCT01995318|"~     Study hypothesis: Kinesiotaping is effective in treatment of acute ankle sprains in emergency~     department. It enhances Karlsson score more than elastic bandage.~   "
120116|NCT01995305|"~     Fanconi anemia is a rare autosomal or sex linked recessive genetic disease. The disease is~     characterized by bone marrow hematopoiesis failure, multiple congenital abnormalities, and~     susceptibility to neoplastic diseases. The cells of FA patients are extremely sensitive to~     MMC and DEB. The symptoms and ages of FA patients are different, so by comparing the exome of~     FA patients and their parents, the mutations that were accumulated in FA patients could be~     found, and these genes might be sensitive to repairment and be important for hematopoiesis~     maintainance.~   "
120117|NCT01995292|"~     The purpose of this study is to determine whether modified spray as you go technique using~     the Enk Fiberoptic Atomizer Set during awake fiberoptic intubation is more comfortable for~     the patient.~   "
120118|NCT01995279|"~     The aim of the present project is to examine the effects of single session of French ear~     acupuncture on pain sensation and on postural control in individuals with chronic low back~     pain.~      We hypothesize that:~      I) The application of French ear acupuncture at specific points to reduce low back pain would~     decrease pain intensity in patients with chronic low back pain.~      II) The pain reduction would be greater for those individuals with low back pain who receive~     application of French ear acupuncture at specific points to reduce low back pain compared~     with patients who receive placebo treatment.~      III) The application of French ear acupuncture at specific points to reduce back pain will~     have positive effect on the performance of the postural control system.~   "
120119|NCT01995266|"~     Patients with chronic hepatitis genotype 1b, who are intolerant or ineligible to Interferon~     alfa therapy with or without Ribavirin, will be treated for 24 weeks with Daclatasvir (DCV)~     Dual regimen (= Daclatasvir + Asunaprevir) and followed for an additional 24 weeks~     post-treatment in order to determine the safety and efficacy of the DCV DUAL regimen~   "
120120|NCT01995253|"~     The aim of this study was to find functions for estimating energy expenditure in free-living~     conditions. This method was based on accelerometry data acquired from a smartphone worn in a~     trouser pocket. The developed functions have been compared to the estimations provided by two~     research devices named Armband and Actiheart.~   "
124663|NCT01935700|"~     This trial is to evaluate the potential of colchicine for the palliative management of~     hepatocellular carcinoma patients with distant metastasis or large vessel invasion using the~     Department of Health R.O.C. approved doses and methods of administration.~   "
120122|NCT01995227|"~     The purpose of this study is to determine the safety and the immunological, radiological, and~     pathological response of the personalized anti-cancer vaccine AlloVax(TM) in patients with~     refractory Hepatocellular Carcinoma (HCC) and who are not eligible for any approved HCC~     treatments or have failed all approved HCC treatments. AlloVax(TM) is a personalized~     anti-cancer vaccine combining Chaperone Rich Cell Lysate (CRCL) as a source of tumor antigen~     prepared from patient's tumor and AlloStim(TM) as an adjuvant. The combination of these two~     components provides a vaccine designed to bring out an immune response capable of finding and~     killing the tumor cells.~   "
120123|NCT01995214|"~     Delirium is defined as an acute onset and fluctuating course of mental status change with~     inattention and an altered level of consciousness. Delirium in the postoperative period can~     be divided into emergence delirium and postoperative delirium, based on the time of onset~     (Silverstein et al., 2007).Postanaesthesia delirium is a frequent and potentially serious~     problem affecting the safety of patients and medical personnel. Clinical studies demonstrated~     that postoperative delirium is associated with worse outcomes such as prolonged hospital~     stay, postdischarge institutionalization, and increased mortality (Ely et al., 2004a;~     Thomason et al., 2005; Robinson et al., 2009). Multiple factors may contribute to the~     development of postoperative delirium, including patient's medical condition, administration~     of anesthetics or analgesics and degree of operative stress (Yildizeli et al., 2005; Robinson~     & Eiseman, 2008; Deiner & Silverstein, 2009). Sevoflurane anesthesia have been reported to be~     associated with more emergence delirium in pediatric patients, when compared with propofol~     anesthesia. It is not clear if propofol anesthesia will benefit the geriatric patients on~     postoperative delirium, when compared with sevoflurane anesthesia. We hypothesize that~     propofol anesthesia will reduce the rate of postoperative delirium by 50% when compared with~     sevoflurane anesthesia.~   "
120124|NCT01995201|"~     This multicenter, open-label study will evaluate the efficacy and safety of subcutaneously~     administered RoActemra/Actemra (tocilizumab) as monotherapy or in combination with~     methotrexate or other non-biologic DMARDs in patients with active rheumatoid arthritis and an~     inadequate response to non-biologic DMARDs or to one anti-TNF. In Phase 1, all patients will~     receive RoActemra/Actemra 162 mg subcutaneously (sc) weekly for Weeks 1 to 24, with or~     without methotrexate or other non-biologic DMARDs. For Part 2, patients who achieve sustained~     clinical DAS28-ESR remission at Weeks 20 and 24 will be randomized to receive~     RoActemra/Actemra 162 mg sc either weekly or every 2 weeks for Weeks 24 to 48, with or~     without methotrexate or other non-biologic DMARDs. Patients who do not achieve sustained~     clinical remission but achieve low disease activity (DAS-ESR </= 3.2) will continue the~     initial treatment of RoActemra/Actemra 162 mg sc weekly for Weeks 24 to 48, with or without~     methotrexate or other non-biologic DMARDs.~   "
120125|NCT01995188|"~     This open-label, multicenter, phase 1b study will evaluate the safety and pharmacokinetics of~     DNIB0600A in participants with platinum-sensitive ovarian cancer (PSOC) or Non-Squamous~     Non-small Cell Lung Cancer (NSCLC). The maximum tolerated dose of intravenously infused~     DNIB0600A in combination with carboplatin will be determined in escalating dose cohorts. The~     combination of DNIB0600A and carboplatin will then be evaluated with and without bevacizumab~     [Avastin] in three dose expansion cohorts.~   "
120126|NCT01995175|"~     The purpose of this study is to assess the incidence and associated healthcare utilization of~     RSV-associated, suspected LRTI in a general population of infants from birth up to 2 years of~     age, and also to assess the accuracy of a newly developed LRTI case definition and severity~     scale compared to two existing definitions. The study will also assess the population~     attributable risk percent of RSV LRTI on the development of wheeze and asthma from 0 to 6~     years of age.~   "
120127|NCT01995162|"~     The aim of this study was to validate functions for estimating energy expenditure in~     free-living conditions. This method was based on accelerometry data acquired from a~     smartphone worn in a trouser pocket. The developed functions have been compared to the~     estimations provided by two research devices named Armband and Actiheart.~   "
120128|NCT01995149|"~     Background: Lipid lowering response to weight loss in subjects with genetic hyperlipidemias~     and overweight or obesity and its effect on cholesterol metabolism has not been studied.~      Objective: To explore the effects of weight loss on lipid values and cholesterol metabolism,~     by measuring circulating non-cholesterol sterols, in overweight or obese subjects with~     genetic hypercholesterolemias.~      Design: The investigators conducted a 6-months weight loss intervention in subjects with the~     diagnosis of familial hypercholesterolemia (FH) or familial combined hyperlipidemia (FCHL),~     body mass index >25 kg/m2, steady weight (±3 kg in the last 3 months) and absence of lipid~     lowering drugs in the previous 5 weeks. They were advised to follow a hypocaloric diet with a~     deficit of 600 kcal (30% fat, 15% protein, and 55% carbohydrates) per day as calculated from~     the person's resting energy expenditure and activity level. Anthropometric data, biochemical~     analysis including lipids, apolipoproteins and non-cholesterol sterols were evaluated at~     baseline, 3 months and 6 months.~   "
120129|NCT01995136|"~     The purpose of this study is to investigate IOP reduction efficacy of travoprost 0.004%~     ophthalmic solution (TRAVATAN Z®) in subjects with normal tension glaucoma.~   "
120130|NCT01995123|"~     The purpose of this study is to examine whether behavioral activation as an adjuvant to~     standard smoking cessation treatment improves smoking cessation outcomes among veterans with~     PTSD relative to a comparably intense combination of standard smoking cessation treatment +~     health and smoking education. It is expected that behavioral activation will produce more~     successful results than health and smoking education when paired with standard smoking~     cessation treatment.~   "
120131|NCT01995110|"~     The study will quantitatively evaluate the metabolic response of normal weight and obese~     subjects to three high-fat meals differing in caloric dose by analysing the postprandial~     blood transcriptome.~   "
120132|NCT01995097|"~     Primary Aim: To test the efficacy of a SMS text-based scheduled gradual reduction (SGR) and~     counseling intervention to promote smoking cessation in the late third trimester.~      Hypothesis: The rate of smoking cessation in the late third trimester among women in the SGR~     Support Messages arm will be higher than among women in the Support Messages arm.~      Secondary Aim 1: To assess the effect of the SGR intervention on biochemically validated~     prolonged abstinence and smoking reduction during pregnancy.~      Secondary Aim 2: To assess the effect of the SGR intervention on smoking abstinence at three~     months postpartum.~      Secondary Aim 3: To assess the effect of the SGR intervention on the rate of preterm birth.~   "
120133|NCT01995084|"~     Several studies have shown that tumour hypoxia may have a negative impact on the outcome of~     anticancer treatment. Assessment of tumor hypoxia at baseline or shortly after start of~     treatment may serve as a predictive marker to determine treatment efficacy at an early stage.~     Preferably, such an assessment is performed in vivo and non-invasively.Non-invasive imaging~     with positron emission tomography (PET) using the 2-nitroimidazole nucleoside analogue,~     3-18F-fluoro-2-(4-((2-nitro-1H-imidazol-1-yl)methyl)-1H-1,2,3-triazol-1- yl)propan-1-ol~     (18F-HX4), was tested as a new marker of tumor hypoxia. Before hypoxia-measurements can be~     clinically implemented for response prediction, the reproducibility of the technique should~     be assessed for each specific tumor type. Knowledge of reproducibility is needed to determine~     what change in parameters between two examinations can be considered relevant in an~     individual patient. Assessment of reproducibility becomes even more important in early~     response monitoring since the changes in the tumor induced by the treatment may be smaller~     during the treatment compared to response monitoring after completion of treatment. Also, as~     image quality of 18F-HX4-PET increases with increasing time intervals after injection,~     determination of the optimal time point for measurement of hypoxia is warranted.~   "
120134|NCT01995071|"~     The purpose of this study is to evaluate the safety and antiviral effect of multiple doses of~     ABT-493 and ABT-530 in adults with genotype 1 HCV.~   "
120135|NCT01995058|"~     This study is designed to evaluate the safety and efficacy of combining abiraterone (with~     prednisone) with cabozantinib in chemotherapy-naïve subjects with bone-metastatic~     castration-resistant prostate cancer (CRPC).~   "
120136|NCT01995045|"~     The aim of this study is to evaluate if patients receiving a steroid (triamcinolone~     acetonide) combined with local anesthesia and antibiotic following retina surgery have better~     postoperative pain control those receiving local anesthesia and antibiotic alone.~   "
120137|NCT01995032|"~     The purpose of the study is to show that the intake of L-citrulline and metformin improves~     muscle function and delay of progression in patients with Duchenne's muscular dystrophy.~   "
120138|NCT01995019|"~     The hypothesis is that a single dose intra-articular injection of corticosteroids are~     effective in relieving temporomandibular arthralgia pain.~      The purpose of the study is therefore to evaluate the effect of a single dose intra-articular~     methylprednisolone vs. placebo in a month perspective on subjects with unilateral arthralgia~     of the TMJ.~   "
120139|NCT01995006|"~     The planned study is a single-center, randomized, open-label parallel group study in 16~     healthy male subjects. Study subjects will be randomly allocated either to the metamizole~     group (1) or to the naproxen group (2). All participants will start with a low sodium diet~     (approximately 50 mmol Na+ per day) 7 days before the first drug intake and maintain the diet~     until the end of the study (14 days in total). Salt-depletion is an accepted model to enhance~     production of vasodilatory prostaglandins and to increase renal sensitivity to prostaglandin~     inhibition. On the first day of treatment (Day 1), a single dose of metamizole or naproxen~     will be administered to investigate the effects after a single dose and to collect single~     dose pharmacokinetic profiles. Starting on Day 2, all participants will receive therapeutic~     doses, i.e. 1000 mg metamizole 'ter in die' (TID, three times a day) or 500 mg naproxen 'bis~     in die' (BID, twice a day) for one week and on Day 7 pharmacokinetics and pharmacodynamics~     effects will be assessed under near steady-state conditions.~      The primary objective is the characterization of the renal effects of metamizole by~     determination of the glomerular filtration rate (GFR) using the inulin clearance. Secondary~     objectives are the characterization of the urinary excretion of prostaglandin E2 (PGE2) and~     the prostaglandin I2 (PGI2) metabolite 6-keto-prostaglandin F1 (PGF1)alpha as well as the~     urinary excretion of sodium and potassium.~      Overall, clinical experience suggests better renal tolerability of metamizole possibly due to~     less potent COX-inhibition compared to classical nonsteroidal antiinflammatory drugs~     (NSAIDs). If this could be confirmed, metamizole would be a valuable alternative for~     treatment of painful conditions in patients with impaired renal function. Therefore, the aim~     of this study is to examine the effects of metamizole on renal function in comparison with~     the non-specific COX-inhibitor naproxen.~   "
120140|NCT01994993|"~     The main purpose of this study is evaluate whether it is safe or not to use various~     combination of antibiotics (ampicillin, metronidazole, clindamycin, piperacillin-tazobactam,~     gentamicin) in treating infants with complicated intra-abdominal infections~   "
120141|NCT01994980|"~     Hypothesis: 4 days of antibiotic therapy, as compared to 8 days, is equally effective and~     results in decreased antibiotic exposure among surgical ICU patients with early VAP.~   "
120142|NCT01994967|"~     Clinical trial phase III, noninferiority, controlled, double-blind, randomized. The purpose~     of this study is to evaluate the noninferiority between Levobupivacaine and Bupivacaine in~     spinal anesthesia.~   "
120143|NCT01994954|"~     The investigators hypothesize that Recorded Home Oximetry (RHO) utilization will not increase~     rates of respiratory-related re-hospitalizations and ED visits, and will not impair growth~     compared to standard oxygen management protocols.~      Evidence-based specific consensus guidelines for home regulated oxygen management do not~     currently exist. Current strategies for infants requiring outpatient supplemental home oxygen~     include brief checks of oxygen status during monthly clinic visits. Although the infants stay~     on monitors, no data in between visits is obtained to ensure that infants can maintain oxygen~     levels after weans are made. Before finally allowing oxygen to be removed, many centers also~     require an overnight sleep study in the hospital, to make sure that the infant's oxygen~     levels stay safe when the infant is in deep sleep. Because these methods rely solely on~     assumptions rather than individually recorded data, an infant's time on supplemental oxygen~     may be prolonged or insufficient. This study will evaluate both the currently used accepted~     therapy and a method of weaning that involves recording and sending oxygen data for analysis~     in between clinic visits.~      Premature infants who require home oxygen therapy at time of discharge who meet eligibility~     criteria will be randomized into two arms:~      Arm A (Standard therapy): Infants' oxygen will be increased, decreased, or maintained based~     on brief structured assessments during monthly clinic visits.~      Arm B (Recorded Home Oximetry (RHO)): Infants will have the same monthly clinic assessments~     as in Arm A, but also will utilize Recorded Home Oximetry (RHO) to potentially increase,~     decrease or maintain oxygen between monthly visits.~      Parents of all infants will be interviewed using structured quality-of-life questionnaires at~     the beginning and ending of the oxygen management process. Health care utilization (emergency~     department visits and rehospitalizations) and growth will be assessed 6 months after~     discontinuation of oxygen.~      The investigators overall objective is to determine whether Recorded Home Oximetry (RHO) can~     improve caregiver quality of life, and can shorten Home Oxygen Therapy (HOT) duration and~     eliminate need for polysomnogram, without compromising safety. The investigators will~     determine respiratory-related re-hospitalizations, emergency department (ED) visits, and~     growth parameters to confirm safety of the proposed weaning strategies.~   "
120144|NCT01994941|"~     This study aims to compare the outcome between genotype guided versus clinical guided~     approach in selection of oral P2Y12 receptor blocker in Chinese patients suffering from acute~     coronary syndrome.~   "
120145|NCT01994928|"~     Preoxygenation is routinely performed before endotracheal intubation. In the intensive care~     unit, preoxygenation is often accomplished using a nose-mouth mask. It seems probable that~     high flow nasal cannula oxygen, which is used in the treatment of patients with hypoxemic~     respiratory failure, is equally effective in preventing the development of hypoxemia during~     intubation. In this prospective randomized study preoxygenation using high flow nasal cannula~     oxygen is compared with preoxygenation via nose-mouth mask in patients with hypoxemic~     respiratory failure.~   "
120146|NCT01994915|"~     Chronic obstructive pulmonary disease is a chronic condition involving an impairment in~     functionality and in the execution of activities of daily life. The hypothesis of this study~     is that an occupational therapy intervention added to a physiotherapy program and a medical~     treatment increase the functionality and the quality of life of patients with chronic~     obstructive pulmonary disease.~   "
120147|NCT01994902|"~     The aim of the investigation was to investigate the performance and safety of a new ostomy~     product.~   "
120148|NCT01994889|"~     This Phase 3 study will investigate the efficacy, safety and tolerability of an oral daily~     dose of 20 mg or 80 mg tafamidis meglumine capsules compared to placebo in subjects with~     either transthyretin genetic variants or wild-type transthyretin resulting in amyloid~     cardiomyopathy.~   "
120149|NCT01994876|"~     To investigate the performance and safety of two newly developed convex 1-piece ostomy~     appliances~   "
120150|NCT01994863|"~     The objective of the investigation is to document New Mio 1-piece is non-inferior (no worse)~     in reducing leakage (4-point scale) compared to Standard of Care.~   "
120151|NCT01994850|"~     This is a Phase I/II multicenter single arm non-randomized open label study of the~     investigational drug, brentuximab vedotin, given in combination with routine chemotherapy~     (rituximab, cyclophosphamide, doxorubicin and prednisone) every 3 weeks for a total of 6~     cycles.~   "
120152|NCT01994837|"~     This was a Phase 2, open-label, multicenter study evaluating the preliminary efficacy and~     safety of venetoclax (ABT-199) administered orally in participants with acute myelogenous~     leukemia (AML).~   "
120153|NCT01994824|"~     Graft-vs-host disease (GVHD) causes substantial mortality, morbidity and poor quality of life~     after blood or marrow transplantation (BMT). In Alberta, we use antithymocyte globulin (ATG,~     given on days -2, -1 and 0) in addition to methotrexate and cyclosporine for GVHD~     prophylaxis. In spite of that, ~40% patients develop significant GVHD (grade 2-4 acute GVHD~     or chronic GVHD needing systemic immunosuppressive therapy). ATG at the dose we typically use~     (4.5 mg/kg) is relatively non-toxic. At higher doses, ATG could increase the likelihood of~     posttransplant infections or relapse. Thus an extra dose of ATG (on top of the routine 4.5~     mg/kg) might be justified only for patients at high risk of developing significant GVHD. In~     our experience, low serum level of interleukin-15 (IL15) and high serum level of~     interleukin-2 receptor alpha (IL2Ra) on day 7 predict development of significant GVHD. Here~     we will test whether, compared to historical/concurrent controls, an extra dose of ATG (3~     mg/kg on day 8) given to patients with low IL15 or high IL2Ra on day 7 reduces the incidence~     of significant GVHD, and improves survival free of relapse and GVHD, and quality of life.~   "
120154|NCT01994811|"~     The Eastern Caribbean Health Outcomes Research Network (ECHORN) is a collaborative research~     study that examines the lifestyles, eating habits, and health behaviors associated with~     cancer, diabetes and heart disease in adult men and women living in the Eastern Caribbean.~   "
120155|NCT01994798|"~     This registry is designed to assess the clinically relevant benefits of balloon angioplasty~     and stenting in superficial femoral and popliteal artery, using rapid exchange technology.~   "
120156|NCT01994785|"~     This study will provide capnography monitoring during routine upper endoscopy and colonoscopy~     with moderate sedation in order to see if it improves safety.~   "
120157|NCT01994772|"~     Cardiac arrest is at present a major cause of mortality as well as a cause of disability for~     the surviving victims.In Europe, every year counts as 300,000 cardiac arrests responsible for~     250,000 deaths. Thus, less than 20 % of patients discharged home with impaired quality of~     life associated with symptoms of tiredness, stress, anxiety. The prognosis is related to the~     initial cardiac rhythm present during the initiation of resuscitation. Recent progress in the~     improvement of mortality and neurological outcome has been achieved over the last decade~     thanks to the systematic implementation of a period of targeted temperature control between~     32 and 34 ° C in patients who benefited from the realization of at least one electrical~     external shock.~      There are theoretical and clinical arguments to think that achieving the same way a period of~     targeted temperature control between 32 and 34 ° C in patients treated for cardiac arrest~     with a non- shockable rhythm on arrival can also benefit from this procedure. However other~     arguments are against this hypothesis including an increase in the risk of infection ,~     worsening of the patient's hemodynamic status with no benefit to him. To answer this~     question, we conduce a randomized multicenter study testing the potential improvement of~     neurological outcome through this procedure targeted temperature control between 32.5 and~     33.5 ° C in these patients.~   "
120158|NCT01994759|"~     The purpose of this study is to determine whether reduced load to patients with plantar~     fasciitis (reduced standing, walking, landing) together with either controlled heavy~     resistance training or glucocorticosteroid injection or a combination thereof is the best~     treatment.~   "
120159|NCT01994746|"~     The primary objective of this study is to assess the effectiveness and safety of 3 mg~     glucagon (AMG504-1) administered as a puff into the nose compared with commercially-available~     glucagon given by injection.~   "
120160|NCT01994733|"~     Patients with end-stage renal disease (ESRD) who have elevated serum phosphate (P) levels~     have significantly higher mortality rates compared to those with normal P. In patients~     receiving conventional dialysis regimens, serum P may be lowered through dietary intervention~     and use of P binders, though these have potentially important side effects and may adversely~     impact quality of life. Whether lowering P, and / or targeting specific P levels improve~     survival and clinical outcomes is unknown. Despite this uncertainty, over 90% of patients~     with ESRD receive P lowering therapy and guidelines for the care of patients with ESRD are~     increasingly calling for more aggressive phosphate lowering. This intensive P lowering~     results in extra medications (and their associated side-effects), and higher health care~     costs. We are uncertain whether the intensification of P control results in measurable~     benefits to patients with ESRD. The overall goal of this pilot trial is to evaluate the~     feasibility of conducting a randomized controlled trial of intensive vs liberalized phosphate~     control among hemodialysis recipients.~   "
120175|NCT01994525|"~     This study is to assess the safety, tolerability, and biomarkers of protection in healthy~     malaria-naïve adults, who will receive bites from Anopheles stephensi mosquitoes either~     infected with Plasmodium falciparum Sporozoites (PfRAS) (true-immunization) or noninfected~     (mock-immunization).~   "
120161|NCT01994720|"~     The primary objective of the study is to compare the effect of 90-day treatment with~     ticagrelor (180 mg [two 90 mg tablets] loading dose on Day 1 followed by 90 mg twice daily~     maintenance dose for the remainder of the study) vs acetylsalicylic acid (ASA)-aspirin (300~     mg [three 100 mg tablets] loading dose on Day 1 followed by 100 mg once daily maintenance~     dose for the remainder of the study) for the prevention of major vascular events (composite~     of stroke, myocardial infarction [MI], and death) in patients with acute ischaemic stroke or~     transient ischaemic attack (TIA).~   "
120162|NCT01994707|"~     The investigators aim to definitively show if human myocardium can be remotely~     preconditioned. In the writings there are no experiments that would prove that the remote~     preconditioning protocol effects on the higher protection of the human myocardial cells,~     against the ischemia-reperfusion injury.~      120 patients referred for coronary artery bypass grafting (CABG) procedure with use of~     cardiopulmonary bypass are planned will be included to the research. Patients will be~     randomized (1:1) to one of two groups: remote preconditioning or placebo intervention. On~     the day of surgery, after induction of anesthesia remote preconditioning will be elicited by~     3 cycles of 5min inflation (ischemia) and 5 min deflation (reperfusion) of blood pressure~     cuff on the right arm. In the control group the blood pressure cuff is going to be placed on~     the upper limb but the preconditioning protocol will not be carried out. On cannulation for~     CPB, right atrial appendage and myocardial biopsies of the left ventricular will be~     harvested. The investigators will study: (1) resistance of myocardium to hypoxia/reperfusion~     injury in in vitro experiments, assessed in isolated right atrial pectinate muscle trabeculae~     (2) induction of apoptosis and status of mitochondria in myocardium after the period of~     ischemia, and reperfusion in vitro (3) amount of myocardial necrosis in-vivo induced by~     period of ischemia and reperfusion during CABG as assessed by postoperative myocardial~     necrosis markers release (4) the systolic function of the myocardium at the postoperative and~     the kidney function in the postoperative period evaluated by the creatinine clearance; (5)~     induction of apoptosis and status of mitochondria in myocardium after the period of ischemia,~     and reperfusion during coronary artery bypass grafting, assessed in myocardial.~      There is going to be an ability to define does the remote preconditioning influence on the~     occurrence of apoptosis in the human myocardium in the in vivo conditions and does it~     influence on the postoperative course in patients undergoing cardiac surgery procedures. The~     investigators will try to study if remote preconditioning modify induction of apoptosis and~     its structure in response to injury. In case the effect of remote preconditioning is not~     measurable in ex-vivo assessment, the future attempt at implementing this phenomenon in~     clinical practice may be futile and should not be continued until the effect can be confirmed~     in controlled experimental setting.~   "
120163|NCT01994694|"~     People with ADHD often engage in risky behaviors, such as dangerous driving, substance abuse~     and gambling. Current behavioral economy theories differentiate between risk perception and~     risk attitude. This study aims to measure both risk taking and risk perception in adults with~     and without ADHD. It is hypothesized that people with ADHD show decreased risk perception,~     accounting for their risky behavior. In contrast, it is hypothesized that people with ADHD do~     not show increased risk attitude, namely, they are not risk seeking.~   "
120164|NCT01994681|"~     Volatile Organic Compounds (VOC) in human breath are captured and analyzed by the~     Spectrosense EVA system, which is combination of a gas chromatography (GC) and software~     algorithm. The objective is to obtain a set or sets of VOC bio-markers that will provide the~     best discrimination between Pancreatic Cancer sick population and healthy population. The~     gold standard for identifying sick/healthy population is biopsy proven Pancreatic cancer.~   "
120165|NCT01994668|"~     The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of 2-mg~     lorazepam intravenous administration in healthy Japanese adult subjects.~   "
120166|NCT01994655|"~     Climacteric symptoms can be treated by doing exercise,not hormone replacement therapy.~   "
120167|NCT01994642|"~     The objective of this study is to compare the relative efficacy and safety of the test~     formulation of ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension (Par) to the~     already-marketed formulation CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%) sterile otic~     suspension (Alcon) in the treatment of acute bacterial otitis media in children with patent~     tympanostomy tubes.~   "
120168|NCT01994629|"~     Evaluate the immune response and reactogenicity of one dose of Meningococcal ACWY-cross~     reactive material (CRM) and Meningococcal ACWY-tetanus toxoid (TT) in 12-15 months old~     healthy toddlers.~   "
120169|NCT01994616|"~     This prospective evaluation studies the effectiveness of IL cryotherapy in treating keloids~     and hypertrophic scars in a large population of mixed Fitzpatrick skin types.~   "
120170|NCT01994603|"~     This trial will pilot test intervention strategies to increase utilization of HIV testing and~     gain knowledge for designing a clinical trial to evaluate prevention strategies to reduce HIV~     sexual transmission in the general population in Russia. The study will assess whether~     external (cost, convenience) or internal factors (low perception of own risk, reluctance to~     identify a partner as at-risk, fear of stigma) drive Russian women's reluctance to be tested~     and if peer support impacts their decision. A randomized experimental manipulation, comparing~     opt-in vs. bundled opt-out testing approaches, followed by focus group discussions, followed~     by a second-chance testing offer will be used to inform these questions. The answers will~     enable the international research team to engineer and then test an HIV testing promotion~     strategy in Russia. The project will collect preliminary data for a larger study to develop~     an evidence-based program to reduce the HIV transmission in this high risk population.~   "
120171|NCT01994590|"~     The goal of this clinical research study is to learn if adding dovitinib to the combination~     of abiraterone acetate and prednisone may help to control metastatic CRPC. The safety of this~     drug combination will also be studied.~   "
120172|NCT01994577|"~     Blood tests may be able to quickly identify and exclude patients that are having a heart~     attack. Using these tests in the Emergency Department (ED) may lead to faster treatment, a~     reduced wait time, and quicker discharge for patients presenting with symptoms suggestive of~     a heart attack.~   "
120173|NCT01994564|"~     Glaucoma is a progressive disease resulting in loss of retinal nerve cells and their axons~     (retinal nerve fibers). Retinal nerve fibers are ordered in a special manner when they enter~     the optic nerve. Hence, damage to the retinal nerve fibers by glaucoma results in visual~     field defects at certain locations. Furthermore, the retinal nerve fiber layers from~     different receptors for different colors are ordered in a special manner as well. Thus, it is~     possible that glaucomatous damage causes color vision dysfunction (dyschromatopsia).~      At the moment there is disagreement whether dyschromatopsia occurs at early- to mid-stage or~     only in end-stage glaucoma.~      By testing color vision in glaucoma patients the prevalence of dyschromatopsia in glaucoma~     and in different stages of the disease will be investigated.~   "
120174|NCT01994538|"~     This study will investigate the treatment of urinary tract infection in men. Specifically,~     the investigators are looking to see if shorter duration of antibiotics (7 days) is any worse~     than longer duration of antibiotics (14 days). The investigators will also study whether~     longer treatment leads to an increase in antibiotic resistant bacteria in the large intestine~     (colon), or an increase in drug side effects.~   "
120176|NCT01994512|"~     A national randomized multicentre trial (RCT) where decompression is compared with~     decompression with simultaneous fusion in 245 patients with spinal stenosis on one or two~     adjacent lumbar levels with or without degenerative olisthesis. The material is stratified~     for the existence of degenerative olisthesis >3mm. Monitoring is performed with clinical~     results from patient surveys after 2 and five years, and with radiological follow-up (MRI, CT~     and plain X-ray) and an objective function test (6 min walking test) after 2 years. The null~     hypothesis is that there is no difference in results between the two interventions.~   "
120177|NCT01994499|"~     Infectious pleural effusion is a classic complication of pneumonia and often require pleural~     drainage.~      There is no consensus between surgical drainage and medical drainage indication in first~     intention to treat an empyema.~      Usually surgery is proposed in second intention after failure of medical drainage.~      Videothoracoscopy is well accepted in diagnosis and treatment of pleural pathologies. The~     morbidity of this approach is very low with good results and become the gold standard in~     different pleural diseases. The medical drainage can be also very efficient but its results~     depends of the evolution of the pleural effusion. The rate of failure is estimated around~     25%.~      Then, the aim of our study is to compare surgical drainage and medical drainage in first~     intention. The first end-point will be the hospital stay (day). Hospital discharge will be~     strict, following different objective criteria of healing allowing comparison between these~     two approaches of drainage.~      To answer this question we will randomized 50 patients in 2 years with a multicenter~     recruitment.~   "
120178|NCT01994486|"~     This is an open-label, multi center study of treatment-naive non-cirrhotic subjects with~     genotype 1 chronic Hepatitis C Virus. All subjects will receive telaprevir (TVR) in~     combination with sofosbuvir (SOF) for 12 weeks.~   "
120179|NCT01994473|"~     This is a study designed to evaluate the safety, tolerability, and PK of SEP-363856 and its~     metabolite SEP-363854 in male and female subjects with schizophrenia.~   "
120180|NCT01994460|"~     The current standard short-course treatment for pulmonary TB requires 6 months to complete.~     This long duration of treatment increases the likelihood of side effects while decreasing~     patients' adherence to anti-TB drugs. Linezolid showed considerable efficacy against~     refractory multidrug-resistant TB. Considering the marked anti-TB effects of linezolid as~     well as the possible adverse effects of its long-term use, it is rational to use linezolid~     instead of ethambutol for the first 4 weeks of treatment for drug-susceptible pulmonary TB.~     Through randomized controlled trial, the investigators will evaluate the hypothesis that the~     use of linezolid instead of ethambutol will increase the sputum culture conversion rate by~     15% after 2 months of treatment. Patients with TB without resistance to rifampicin will be~     randomized to the following three arms at a 1:1:1 ratio: Arma 1 (control arm), Arm 2~     (linezolid for 2 weeks instead of ethambutol), Arm 3 (linezolid for 4 weeks instead of~     ethambutol)Primary outcome will be sputum culture conversion rate after 2 months of treatment~     (liquid media).~   "
120181|NCT01994447|"~     Project Summary: One of the challenges facing pediatric researchers is the need to balance~     decreasing funding with the time and human resource costs associated with enrolling children.~     In order to address this, the Emergency Department (ED) research team developed an innovative~     model for subject enrollment and consent using highly trained and supervised undergraduate~     students. From a human resources perspective, utilizing students is more cost effective than~     the traditional research nurse model. However, a concern with this method is the adequacy of~     parental understanding of study information for informed consent. The aim of this project is~     to determine if the use of students is at least as good as the more costly gold standard of~     experienced research nurses. The validation of this innovative student model will enable~     child health investigators to better meet parent's needs and increase the efficiency of~     pediatric research.~      The primary objective of this study is to measure parental comprehension of informed consent~     information using an innovative undergraduate research assistant program compared to consent~     using the traditional research nurse model. We hypothesize that parental comprehension of the~     informed consent information process when approached by undergraduate students will be~     comparable (or not worse) than when consent is obtained by a research nurse.~   "
120182|NCT01994434|"~     Ulnar nerve compression is common at the elbow, but less common at the wrist. The purposes of~     this study are to report a series of 9 patients with pure ulnar nerve deep branch compression~     by a ganglion and to evaluate the outcome following a surgical treatment. According modified~     Bishop's scoring system, the investigators would evaluate postoperative results of this~     uncommon nerve lesion.~   "
120183|NCT01994421|"~     Background: Kinesiotaping (KT) is an elastic therapeutic tape developed in the 70's by Dr~     Kenso Kase for prevention and treatment of sports injuries. Research shows that through~     activation of skin receptors KT improves blood and lymph flow, increases proprioception,~     helps relieve pain, facilitates joint and muscle alignment, and enhances muscle function.~     Despite the increasing popularity of KT, uncertainty remains regarding, in particular, its~     effectiveness in improving strength.~      Purpose: The purpose of the current study was to investigate the short-term effects of KT on~     muscle strength when applied to the quadriceps muscles of healthy subjects.~      Methods: A randomized controlled trial with 52 healthy subjects was conducted. Subjects were~     tested under four different conditions: a) facilitating Kinesiotape, b) inhibiting~     Kinesiotape, c) classical tape with no elastic properties, and d) no-taping across four~     different sessions. The parameters of interest were: quadriceps and hamstrings maximal~     strength and power using vertical jump tests (squat jump and countermovement jump), and peak~     concentric and eccentric knee torque (using isokinetic test protocol).~   "
120184|NCT01994408|"~     High blood pressure leads to heart attacks and strokes which can be prevented by blood~     pressure-lowering medication. However, the current office-based prescription of one pill and~     one dose at a time is ineffective. the investigators want to pilot-test a more effective~     patient-centered treatment approach, where patients will receive a prescription with gradual~     but automatic weekly increases of dose and number of pills. Patients will measure their blood~     pressure with an iPhone compatible cuff, which transmits readings to the doctor or~     pharmacist, who will stop escalation when the desired blood pressure level is reached. The~     investigators hypothesize that the intervention will decrease the time to control blood~     pressure and increase the overall rate of blood pressure control. Therefore, this new~     treatment model could prevent heart attacks and strokes, and reduce healthcare costs.~   "
120185|NCT01994395|"~     Hypothesis/Specific Aims:~      The purpose of this study is to determine the effect of training with the Stride Management~     Assist (SMA) device vs. Impairment based physical therapy (IPT) on descending corticospinal~     drive to the lower limb muscles in patients post stroke. The investigators hypothesize that~     long-term SMA use would strengthen the connections between the motor areas of the brain and~     the lower limbs. Specifically, individuals in the SMA group will show higher corticospinal~     excitability of the lower limb muscles compared to those in the IPT group.~   "
120186|NCT01994382|"~     This study will identify the highest dose, and assess the safety, of cerdulatinib (PRT062070)~     that may be given in patients with relapsed/refractory chronic lymphocytic leukemia or~     non-hodgkin lymphoma~   "
120187|NCT01994369|"~     Breast cancer is the most common cancer and the second cause of cancer mortality in women.~     There are approximately 200,000 new cases of breast cancer a year. Classically, breast~     cancers are divided into two groups, invasive and non-invasive. A mainstay of the treatment~     of both of these types is surgical resection not only for therapeutic purposes but also for~     diagnostic purposes. Breast conserving therapy includes surgical lumpectomy and~     post-operative radiation. However, despite best surgical practices, when patients undergo BCT~     anywhere from 20 - 40% of these patients have margins positive for cancer. This leads to~     increased rates of reoperation which are quoted to be as high as 30% and increased local~     recurrences.~      There is an over expression of folate receptors located on the surface of many human~     carcinoma nodules.Specifically for breast cancer up to 33% of all breast cancers over express~     the folate receptor.~      Folate-fluorescein isothiocyanate, or folate-FITC, also identified as EC-17, targets folate~     receptors over expressed in certain cancers such as breast cancer, and could help in better~     identifying the margins of the cancer thereby achieving negative margins.~   "
120188|NCT01994356|"~     As many as one-third of female healthcare providers use intrauterine contraception (IUC), but~     only about 8 percent of US women overall do. This begs the question: Might physician~     self-disclosure of personal IUC use increase IUC use among patients? However, the positive or~     negative impact of physician self disclosure on IUC uptake or patient satisfaction is~     generally unknown. The purpose of this study was to evaluate if physician self-disclosure of~     personal IUC use increases patient use of IUC or impacts patients' satisfaction with their~     clinical encounter.~   "
120189|NCT01994343|"~     Chronic pelvis pain is very common between adult women. Significant progress is made in~     clarifying the multifactorial model of chronic pain pathogenesis, but a more complete~     assessment is important in order to improve the therapeutic approach. The purpose of this~     study is stablish a clinical and symptomatological profile of women with chronic pelvic pain.~   "
120190|NCT01994330|"~     Acquired Von Willebrand disease (type 2A) has been described in patients with severe aortic~     stenosis, the association of aortic stenosis and Digestive bleeding due to this phenomena has~     received the name of Heye´s syndrome.~      We propose that administering Desmopressin (DDAVP) in patients scheduled to aortic valve~     replacement surgery will reduce blood loss and transfusion rate.~      this was a pilot study~   "
120191|NCT01994317|"~     This study aims to compare an algorithm for IV sedation dosing to the current standard of~     care in patients undergoing first trimester surgical abortion. The primary outcome is~     subjects' pain score with suction curettage on a 0-100 21-point scale. Secondary outcomes~     include pain scores with cervical dilation and 15 minutes post-procedure, subjective pain~     ratings, incidents of side effects and adverse events, the frequency of additional doses of~     medication, recovery room time, and physician assessment of and satisfaction with pain~     control. Investigators hypothesize that this algorithm will result in improved pain control,~     decreased frequency of additional medication doses, improved patient and physician~     satisfaction, without differences in side effects, adverse events or recovery room time.~   "
120192|NCT01994304|"~     PHFI independently evaluated the effectiveness of the Safe Childbirth Checklist program in~     preventing stillbirths and early neonatal deaths. Evaluation used a quasi-experimental design~     with data collection from 34 facilities across six intervention districts and four control~     districts. The study with a sample of 137,000 births has 88% power to detect 15% reduction in~     intrapartum mortality. Data on this was collected over a period of 17 months (November 2013~     to April 2015).~   "
120193|NCT01994291|"~     The study hypothesis under test is that administration of the CCR2/5 antagonist has the~     potential to be as effective as the current treatment options for subjects with diabetic~     macular edema. The current treatment option for these subjects is an injection directly into~     the eye, while this CCR2/5 antagonist would be an oral drug which has the potential to be~     just as effective. This CCR2/5 antagonist also has a broader anti-inflammatory potential and~     might be able to provide an alternative mechanism to treat Diabetic Macular Edema.~   "
120194|NCT01994278|"~     The aim of this study is to observe whether a brushless cleaning device can be equally as~     effective in removing plaque from the teeth as a soft toothbrush. The goal is to give people~     an alternative to bristle brush cleaning if they find they are brushing too hard. The~     hypothesis is that it is possible to maintain healthy teeth and gingiva by using brushless~     methods in conjunction with flossing.~   "
120195|NCT01994265|"~     Cognitive and functional decline observed in atrial fibrillation (AF) patients are related to~     thrombotic and/or cardioembolic events. Use of warfarin for the prevention of stroke in AF~     patients, despite effective, remains beyond desired levels because of interactions with food~     and fluctuations in blood levels. Because of a more stable anticoagulation state, Dabigatran~     may offer better protection against thrombotic phenomenon and, consequently, mitigate the~     process of cognitive and functional compromise.~   "
120228|NCT01993836|"~     This study will examine the hypothesis that changes in the cognition (i.e. thinking and~     memory) after anesthesia and surgery are correlated with changes in markers of Alzheimers~     Disease in the fluid around the brain and spinal cord (i.e. cerebrospinal fluid, or CSF),~     and/or changes in brain connectivity. The investigators will also examine whether different~     types of anesthesia have different effects on these CSF markers of Alzheimers disease, or~     different effects on thinking and memory after anesthesia and surgery, or differential~     effects on the correlation between cognitive changes and CSF marker changes.~   "
120229|NCT01993823|"~     The purpose of this study is to evaluate the safety and efficacy of G238 for the treatment of~     otomycosis~   "
120196|NCT01994252|"~     Atrial fibrillation (AF) and heart failure (HF) are two common heart conditions that are~     encountered with an increase in death and suffering. When both these two conditions occur in~     a patient, the patient's prognosis is poor with a reduced quality of life and impaired heart~     function. These patients have enlarged hearts, specifically the left ventricle (major pumping~     chamber), which impairs the heart's pumping capacity, leading to symptoms such as fatigue,~     shortness of breath from any type of exertion, and swelling, usually of the feet and ankles.~      In these HF patients who are in AF all of the time, who would otherwise be a suitable~     candidate for an implantable defibrillator to prevent sudden cardiac death, we would like to~     determine whether adding pacing of both ventricles will reduce heart size (left ventricular~     end systolic volume index LVESVi) as measured by ultrasound, which can improve its function~     and help the heart pump more efficiently.~      Other studies have shown that adding pacing to both ventricles is of benefit in HF patients~     with mild to moderate symptoms and have a regular heart rhythm. The Investigators now want to~     explore if this therapy will benefit those patients with a permanent irregular heart rhythm~     (AF).~   "
120197|NCT01994239|"~     The purpose of this study is to select the best therapeutic strategy in studying the~     effectiveness of the association of a short duration hormonal therapy and radiotherapy~     compared with radiotherapy alone, in patients with a detectable PSA after radical~     prostatectomy.~   "
120198|NCT01994226|"~     Gout is the most common cause of inflamed joints affecting 1.4% of adults in the UK. Most~     patients are treated entirely in general practice yet primary care management is frequently~     suboptimal. Acute attacks of gout are excruciatingly painful and require urgent drug~     treatment to reduce inflammation, most commonly with antiinflammatory drugs(NSAIDs) or~     colchicine. In primary care, NSAIDs are most commonly used but can cause serious side effects~     such as stomach ulcers and heart disease, particularly in the elderly. Patients frequently~     require repeat prescriptions for recurrent attacks of acute gout increasing the risk of~     drug-related side-effects. Low-dose colchicine is popular amongst rheumatologists as it is~     effective and well tolerated. However, general practitioners (GPs) prescribe colchicine~     infrequently, probably because in the past the recommendation was for high doses to be~     prescribed which commonly caused severe diarrhoea. Recently, prescribing recommendations for~     colchicine have changed, advocating a lower dose regime.~      Currently there is no evidence regarding whether NSAIDs or low-dose colchicine is the best~     treatment for acute gout. This trial will be the first direct comparison of the effectiveness~     and side effects of a NSAID (naproxen) and low-dose colchicine to treat acute gout in primary~     care. Naproxen will be used in this trial because it has been shown to be as effective as~     oral prednisolone for the treatment of acute gout, is safer than other commonly used NSAIDs~     such as diclofenac and indomethacin, and is inexpensive.~      Patients consulting their GP with an acute attack of gout in up to 100 general practices will~     be invited to participate. Treatment success will be assessed by comparing pain reduction~     between the two drugs. The trial will also monitor side effects, quality of life, and cost~     effectiveness.~   "
120199|NCT01994213|"~     Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and~     Flt3. Phase I study has shown that the toxicity is manageable.~      The purpose of this study is to evaluate the efficacy and safety profile of Famitinib in~     patients with advanced or metastatic Gastroenteropancreatic Neuroendocrine Tumor.~   "
120200|NCT01994200|"~     While thyroid cancer is generally associated with a favourable prognosis, there is a~     discrepancy with how important if not traumatic its impact can be on patients. Quality of~     life (QoL) decreases in the year following a thyroid cancer diagnosis, constituting an~     optimal period for a preventive intervention. The goal of this study is to evaluate the~     impact of offering an interdisciplinary team-based care approach for newly diagnosed thyroid~     cancer patients, including a dedicated nurse who will provide important psychoeducational~     elements identified in previous focus group studies of thyroid cancer patients, i.e.,~     information on: the physical illness; the emotional impact of being newly diagnosed with~     thyroid cancer; surgery and its' short- and long-term consequences; radioactive iodine~     treatments and its associated safety precautions, nutrition and dietary considerations; and~     how the cancer diagnosis can be an opportunity to make important lifestyle changes and~     establish new life-priorities.~   "
120201|NCT01994187|"~     Investigate the current situation of carotid stenosis therapy in China. Establish the data~     bank of carotid stenosis revascularization (CAS and CEA) in China ,in order to get best~     quality control of the therapy, as well as confirm the standard treatment for carotid~     stenosis.~      Understand situation about the adverse events occurs after the revascularization (CAS and~     CEA), evaluate the health economics .~   "
120202|NCT01994174|"~     The objective of this research is to determine the effects of anti-VEGF drugs (bevacizumab,~     ranibizumab or aflibercept) on aqueous humor dynamics (AHD) in patients with retinal vascular~     disease. The underlying hypothesis is that anti-VEGF drugs increase intraocular pressure~     (IOP) by increasing aqueous inflow, decreasing uveoscleral outflow or both. The specific aim~     is to evaluate the changes produced in AHD after 1 baseline and a subsequent 1 monthly~     injection of anti VEGF agents.~   "
120203|NCT01994161|"~     This trial is an prospective, government-funded registration study that will observe the~     safety and effectiveness of intracranial stenting for preventing stroke during a mean~     follow-up of 12 months in patients with symptomatic stenosis of a major intracranial artery~     (MCA, carotid, vertebral, basilar). This trial will be launched by Xuanwu Hospital, Capital~     University of Medical Science, with 20 collaborators participating. Enrollment will begin in~     2013, and it aims to have a sample size of 840 subjects in 2 years. The trial is scheduled to~     complete in 2015.~      As we know, SAMMPRIS is flawed with defect in design, heterogeneity in experience and~     credentials of operators and high rate of complication; Whether the interventional therapy~     for symtomatic intracranial artery stenosis is effective or not remained resolved. This trial~     has been modified based on SAMMPRIS in order to acquire the data for China: Technique,~     experience, and credential of the operators are closely related with perioperative~     complications in PTAS. The investigators select 50 large-scale medical centers for~     participation on the basis of geographical distribution. All the participants are ranked as~     top in China. They have the most experienced surgeons or interventionist in China, and are~     fully qualified for this trial. This will guarantee the success and safety of technique,~     maintain the continuity of operator's experience, and make the complication rate as low as~     possible.~   "
120204|NCT01994148|"~     laparoscopy has been increasingly applied in patients with abdominal trauma , as an~     diagnostic and therapeutic modality. However, its clinical benefits are still under~     evaluation. The aim of this study is to prospectively assess the feasibility and safety of~     this technique in the management of traumatic gastrointestinal injury.~   "
121549|NCT01976507|"~     The purpose of this study is to evaluate major adverse bleeding risks, and thromboembolic~     event rates post radiofrequency (RF) ablation. The primary goal is to establish safety of~     dabigatran use for peri-procedural anti-coagulation after left atrial catheter radiofrequency~     ablation, or cryoablation procedures.~   "
120205|NCT01994135|"~     Consumption of carbohydrate containing foods or sugary drinks brings about changes to the~     blood glucose levels. After a meal or drink, blood glucose levels rise until it reaches a~     peak concentration usually after 30 minutes. When the body senses the increase in blood~     glucose, a hormonal process involving insulin takes place to ensure that the glucose is taken~     up from the blood for storage and where it is needed for energy in the body. This process~     then brings about a decrease in the concentration of glucose until it reaches approximately~     the starting concentration. The original concentration of glucose is attained approximately 2~     hours after eating or drinking a carbohydrate food or sugary drink respectively.~      Different carbohydrates and sugary drinks have different effects on blood glucose response~     depending on the amount as well as the type of carbohydrate. Those that give rise to a high~     glucose response compared to a reference carbohydrate (usually glucose) are said to be high~     glycaemic index (GI) foods and those with a lower glucose response compared to a reference~     carbohydrate (usually glucose) are said to be low glycaemic index (GI) foods.(1)~      Research has shown that diets that give rise to a high glucose response are associated with a~     number of abnormalities like increased metabolic syndrome (2). Metabolic syndrome mostly~     comprises of insulin resistance and glucose intolerance which gives an increased risk of type~     2 diabetes. (3) It also gives rise to other conditions like high blood pressure (arterial~     hypertension), elevated blood insulin levels (hyper-insulinemia), elevated amounts of fat in~     the liver (fatty hepatosis) and elevated amounts of lipids in the blood (dyslipidemia). After~     type 2 diabetes become clinically apparent, the risk of cardiovascular disease also rises.~     (4) Research has also shown that foods/drinks which raise blood glucose levels gradually (low~     GI) rather than rapidly (high GI) have health benefits which include reducing the risk of~     metabolic syndrome (5). In vitro studies have shown that polyphenols found in fruits,~     vegetables and plant based foods have a positive effect on carbohydrate metabolism and can~     lower the blood glucose levels. (6)~      This research will determine whether the presence of polyphenols in the diet has any lowering~     effect on the blood glucose levels and hence the glycaemic index of foods. This will be~     determined by asking volunteers to consume polyphenol rich drink/food together with white~     bread and determine the glycaemic response. The GI of bread will be determined initially as a~     reference.~      Analysis will be done by measuring blood glucose response to white bread alone as reference~     and then to white bread with test sample containing polyphenols and then determine GI and see~     how the GI of bread will be affected. Other analyses to be done are plasma insulin, glucagon,~     gastric inhibitory polypeptide (GIP) and glucagon like peptides-1 (GLP-1) as they all relate~     to glycaemic response.~      Study hypothesis is that glucose metabolism will be affected.~      NOTE:~        1. Only healthy participants undertook the study (Hence metabolic syndrome participants not~          part of the study)~        2. Only glucose and insulin were analysed in the plasma (hence GIP, GLP-1 and glucagon not~          part of end points)~   "
120206|NCT01994122|"~     The purpose of this study is to examine differences in selected psychiatric/psychological~     variables between a sample of unemployed young adults who have dropped out of high school and~     a sample of college students.~   "
120207|NCT01994109|"~     This study will evaluate the efficacy and safety of MYOBLOC in the treatment of Sialorrhea~     (drooling), which can be a symptom of many disease conditions. MYOBLOC will be injected~     directly into the salivary glands. MYOBLOC has been shown in previous trials to safely~     decrease saliva production, thereby demonstrating its potential as a safe and effective~     treatment for troublesome sialorrhea.~   "
120208|NCT01994096|"~     Intensive care unit (ICU) patients are especially at risk for invasive candidiasis due to the~     presence of risk factors. It is known that in critically ill patients, alterations in~     function of various organs and body systems can influence the pharmacokinetics and hence the~     plasma concentration of a drug. A study of caspofungin in ICU patients has found a high~     inter- and intra-individual variability in caspofungin concentration. Factors that caused~     subtherapeutic caspofungin plasma concentrations were body weight > 75 kg and~     hypoalbuminemia. Furthermore, an efficacy study showed a lower response rate for caspofungin~     among patients with a higher disease severity score.~      As a result of the altered pharmacokinetics, under- or over-exposure of caspofungin can occur~     in critically ill patients and an adjusted dosage might be necessary in these patients.~   "
120209|NCT01994083|"~     The purpose of this study is to investigate the safety and tolerability of IX-01 after~     multiple doses, and to determine how the body handles IX-01.~   "
120210|NCT01994070|"~     Atrial fibrillation (AF) is the most common type of irregular heartbeat in emergency~     department (ED) patients. If the irregular heartbeat has been present for less than 48 hours,~     there is a chance that emergency treatment can convert the heartbeat into normal rhythm.~      There are currently two options for accomplishing this; both are widely and safely used in~     EDs. Each has its advantages and disadvantages. This study will compare the two methods. (1)~     Patients are given an intravenous medication called procainamide; this converts patients into~     a normal heart rhythm around 50% of the time. (2) Patients are sedated (put to sleep with a~     general anesthetic) for about ten minutes, while an electrical current is conducted across~     the chest; this converts patients into a normal heart rhythm around 90% of the time.~      Procainamide can cause low blood pressure in about 10% of patients; this is usually corrected~     by administering intravenous fluids. Sedation can cause low blood pressure in about 10% of~     patients, and breathing trouble in about 10% of patients; this is usually corrected by~     administering intravenous fluids, and administering more oxygen, respectively. In thousands~     of patients studied around the world, there does not appear to have been a reported stroke or~     death as a result of these procedures.~      A physician will choose one method, but if it fails, will move to the next method. There are~     thus two options. (1) Chemical conversion, followed by electrical conversion; and (2)~     Electrical cardioversion, followed by chemical cardioversion. These options both have a 90%+~     chance of converting AF into a normal heart rhythm. However, the investigators believe that~     an electrical-chemical sequence will be faster than a chemical-electrical sequence, while~     both will be equally safe.~      If patients agree to take part in the study, they will be randomized to one of the two~     options. They will have their breathing, oxygen levels, blood pressure, and heartbeat~     monitored for their entire ED stay.~      The investigators plan to enrol 86 patients at five hospitals over the course of about one~     year. The primary outcome of ED length-of-stay, as well as secondary outcomes, such as~     conversion to normal rhythm, and adverse events (such as trouble breathing or low blood~     pressure) will be documented. In addition, an investigator will contact you at three and~     thirty days after your visit to make sure that there are no problems. Importantly, although~     the principal and site investigators will be aware of the primary outcome, attending~     emergency physicians who actually provide patient care will NOT be aware of the primary~     outcome--otherwise this could bias patient management.~      When the study is finished, the results will be given to the writing committee merely as the~     A and B arms, and not specified as either the chemical-first or electrical-first~     arms. The writing committee will compose two manuscripts, (1) assuming that A is the~     chemical-first arm and B the electrical-first arm, and (2) assuming that A is the~     electrical-firstarm, and B the chemical-first arm. After both manuscripts have been~     approved by all authors, the blinding will be removed and only the correct manuscript~     submitted for publication.~   "
120211|NCT01994057|"~     For patients of advanced NSCLC (non small cell lung cancer) , Individualized cancer therapy~     has been widely accepted since the success of crizotinib administration based on EML4-ALK~     fusion gene detection and gefitinib and erlotinib administration based on EGFR-TKIs sensitive~     mutations.From clinical points of view ,individual differences often occur between different~     patients, leading diverse effect in ADR and drug effect.Meanwhile ,the drug effect and~     adverse drug reaction was significantly influenced by the pharmacokinetic factors and~     pharmacodynamic factors.In this research ,we try to establish a more sensitive method to~     detect sensitive mutations in plasma and discover the correlation between somatic and~     germline mutations , trough concentration and EGFR-TKI drug effect, the association between~     ADME-associated SNP ,trough concentration and EGFR-TKI adverse effect .Furthermore, in vivo~     and in vitro research is also crucial for rational explanation for these clinical phenomenon.~   "
120230|NCT01993810|"~     This randomized phase III trial studies proton chemoradiotherapy to see how well it works~     compared to photon chemoradiotherapy in treating patients with stage II-III non-small cell~     lung cancer that cannot be removed by surgery. Specialized radiation therapy that delivers a~     high dose of radiation directly to the tumor, such as photon or proton beam radiation~     therapy, may kill more tumor cells and cause less damage to normal tissue. Drugs used in~     chemotherapy, such as paclitaxel, carboplatin, etoposide, and cisplatin, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. It is not yet known whether proton chemoradiotherapy is more effective than photon~     chemoradiotherapy in treating non-small cell lung cancer.~   "
121550|NCT01976494|"~     Acute post-operative pain causes not only discomfort for the patient, but delays recovery by~     increasing the morbidity of the circulatory system, respiratory system, and immune system, so~     pain control is one of the important objectives in peri-operative patient management. Patient~     controlled analgesia (PCA) is a piece of equipment for which the patient can personally~     control the administration of an analgesic. It is generally used in postoperative pain~     management because it is a method which can heighten patient satisfaction by reducing~     complications and obtaining the appropriate level of pain relief. Usually, it is designed to~     administer an analgesic at a steady speed, and the patient can administer additional~     medication by pressing a button when the pain is severe. Here, to prevent complications from~     excessive administration of an analgesic, repeated administration is not allowed within a~     certain time interval. The PCA equipment can be categorized as electronic and physical~     according to the force which operates the drug injection pump. Electronic equipment uses~     electrical energy to apply vermicular movement to the fluid tube to administer the analgesic.~     Physical equipment is disposable equipment designed to fill an elastomer reservoir bag~     expanding the material, and its elasticity returns to the original length used to administer~     the analgesic. The physical equipment is easy to carry and movement is comfortable because~     there is no need for additional electronic equipment or devices. There is also no need for~     special training to operate the equipment, and the action mechanism is simple so there is~     less opportunity for malfunction. The disposable physical equipment accounts for~     approximately 70% of the domestic market share and it is preferred over the electronic~     equipment. On the other hand, contrary to the electronic equipment, the physical PCA~     equipment has the disadvantage of not providing information regarding the history of the~     equipment's use. The early physical PCA equipment was very simple and only had the function~     of continually administering medication at a set speed. Hence, it was not sufficient to~     function as 'patient controlled' pain control equipment. Then, the function of an additional~     administration button was added so that the patient can personally decide whether to~     administer an additional amount of analgesic. At the same time, the physical PCA equipment~     has improved to prevent excessive administration by setting a lock-out time as a safety~     measure. The following development was Accufuser Selectuss®, where a function was added to~     select the administration speed from three options. In this way, the physical PCA equipment~     has continued to evolve in the direction of enhancing safety, convenience, and clinical~     effectiveness. The advantage of pain control using PCA equipment is that the patient can~     personally control additional the administration of an analgesic by pressing a button. In the~     case of existing or imported products, it is designed to administer a bolus by pressing the~     button, and the pressure presses the PVC bag filled with medication under the button to~     administer the bolus. Compared to the intravenous route, using an epidural as a PCA~     administration route has superior analgesic effect, so it can reduce the amount of opioid~     analgesic administered. On the other hand, the disadvantage is that it has to pass through a~     narrow and long epidural catheter to deliver the medication to the epidural space which has a~     relatively higher resistance. Woo Young Medical experimented with their own product Accufuser~     plus® (Woo Young Medical, Korea), and the results showed that the time taken to empty the~     bolus bag was approximately 40-80 seconds depending on the dosage. The pressure when a person~     presses the bolus button on the PCA equipment was repeatedly measured to obtain a mean value,~     and this pressure was constantly maintained by a machine to measure the time taken to empty~     the bolus bag. Clinically, it is not easy to continually press the button for 40-80 seconds,~     so it is difficult to exclude the possibility that the bolus was not administered properly.~     In addition, when excessive pressure is applied, there is the possibility that the bolus bag~     may burst. The domestically developed products and Accufuser Omnibus® (Woo Young Medical,~     Korea) was developed for the purpose of supplementing bolus failure which can occur when~     using epidural PCA. Within the bolus module, a second elastomeric balloon is installed behind~     the first bolus bag so the patient does not have to press the bolus button for a long time.~      Therefore, this research focused on the effectiveness and safety of the domestic product~     Accufuser Omnibus® (Woo Young Medical, Korea) regarding whether the bolus is sufficiently~     delivered when it is administered through the epidural route, and compared the results~     through a comparative clinical trial with imported physical PCA equipment (Infusor SV®,~     Baxter, USA).~   "
120212|NCT01994044|"~     Background: The majority of patients suffering a whiplash injury (WAD) will recover, but some~     may have symptoms for years despite all kinds of conservative treatment. The Neck Pain Task~     Force (2008) found no existing evidence for positive effects of fusion operations in such~     patients. Some of them, however, present with symptoms that might indicate pain from a motion~     segment, possibly the disc. Our aim was therefore to test this possibility by performing a~     randomized study comparing cervical fusion and multimodal rehabilitation in chronic WAD~     patients.~      Methods: Patients with a specified symptomatology, all with pronounced symptoms for long~     periods of time, were recruited and randomized to surgery (25 pat.) or to multimodal~     rehabilitation (24 pat.). All patients were investigated before start of the study and at~     follow-up approximately two years after treatment by four independent examiners from~     disciplines usually involved in treating WAD patients. The patients also gave their own~     assessments of the treatment results. Seven patients in each group did not undergo the~     allocated treatment for various reasons.~   "
120213|NCT01994031|"~     The purpose of this study is to determine the maximum tolerated dose (MTD)of paclitaxel~     liposome injection and to compare the pharmacokinetic characters between paclitaxel liposome~     injection and paclitaxel injection and to value the effectiveness for cancer treatment.~   "
120214|NCT01994018|"~     The correlation between relapses in MS and vitamin D intake will be examined.~   "
120215|NCT01994005|"~     The scope of this project was to provide evidence that better contraceptive choices are made~     with more effective counseling as well as improvement in patients' contraceptive knowledge.~     Specifically we wanted to evaluate the use of social media as a means for effective patient~     counseling.~   "
120216|NCT01993992|"~     Post-operative delirium had multiple risk factors, such as pre-operative anxiety status,~     post-operative pain, and anesthetic method. We currently decrease pre-operative anxiety by~     parental accompanying until the children put to sleep. However, references indicate that~     parental anxiety can increase the post-operative delirium. Heart rate variability was used to~     measure the anxiety status of parents. We think sympathetic tone elevation measured by heart~     rate variability may not induce by anxiety alone, thus we want to explore this question by~     using Stat-Trait Anxiety Inventory questionnaire.~   "
120217|NCT01993979|"~     POUT is a multi-centred randomised controlled phase III trial. 345 patients who have~     undergone nephro-ureterectomy, are surgically staged pT2-pT4, N0-3 or are pT1 and node~     positive, and who are fit for adjuvant chemotherapy, will be randomised to four cycles of~     adjuvant platinum based chemotherapy (experimental group) or surveillance (control group).~     Participants will be followed up according to routine practice.~      Primary endpoint: Disease-free survival (DFS)~      Secondary endpoints:~        -  Overall Survival~        -  Metastasis free survival~        -  Incidence of bladder second primary tumours~        -  Incidence of contralateral primary tumours~        -  Acute and late toxicity~        -  Treatment compliance~        -  Quality of life~   "
120218|NCT01993966|"~     Urothelial carcinoma (UC) is the most common cancer of urinary tract. Patients with~     metastatic UC are usually treated with systemic chemotherapy. There still existed 30% to 50%~     of advanced UC not responsive to cisplatin-based chemotherapy; the prognosis for patients~     with metastatic UC remains poor.~   "
120219|NCT01993953|"~     This study is a four armed randomized controlled trial (RCT) where the main purpose is to~     investigate the effect on muscle strength and changes in body composition in overweight (BMI~     ˂ 25) not regularly exercising women aged 18-65, after 12 weeks of Body Pump (BP), compared~     with an inactive control group. The study will also measure energy expenditure during one~     session of BP. At the same time, the project will investigate the effect on muscle strength~     and changes in body composition in group training with, respective without, a personal~     trainer (PT).~      H0: There`s no different between the groups after 12 weeks of Body Pump and traditional~     strength training with and without a personal trainer on muscle strength and muscle mass in~     adult overweight females.~      H1: There is a different between the groups after 12 weeks of Body Pump and traditional~     strength training with and without a personal trainer on muscle strength and muscle mass in~     adult overweight females.~   "
120220|NCT01993940|"~     The purpose of this study is to evaluate the efficacy and safety of naldemedine in the~     treatment of opioid-induced constipation (OIC) in adults with non-malignant chronic pain who~     are not using laxatives.~   "
120221|NCT01993927|"~     To determine the safety and efficacy of long-term use of Voglibose (Basen) to prevent~     progression to type 2 diabetes mellitus in patients with impaired glucose tolerance in the~     routine clinical setting.~   "
120222|NCT01993914|"~     The etiologies of varicose veins and the progression to more serious forms of chronic venous~     disease and identification of appropriate diagnostic tests to better aid patient management~     by identifying individuals who may benefit from more aggressive treatment and/ or~     prophylactic measures.~   "
120223|NCT01993901|"~     The principal aim of this study is to prospectively assess if Clinical Specialist Radiation~     Therapist (CSRT) led telephone follow up after treatment with lung Stereotactic Body~     Radiation Therapy (SBRT) has an impact on patient symptom burden as assessed by Edmonton~     Symptom Assessment Scale (ESAS) scores.~   "
120224|NCT01993888|"~     To evaluate the safety and hemostatic effectiveness of EVARREST® Fibrin Sealant Patch~     (EVARREST) versus standard of care treatment (SoC) in controlling parenchymal bleeding during~     hepatic surgery.~   "
120225|NCT01993875|"~     To evaluate the pharmacodynamics and tolerability of a liquid formulation of lubiprostone, as~     compared to matching placebo, when administered orally to subjects with chronic idiopathic~     constipation. Additionally, liquid formulation pharmacokinetics, including a comparison of~     fed and fasted pharmacokinetics, of the liquid formulation will be performed in a subset of~     subjects.~   "
120226|NCT01993862|"~     The purpose of this study is to determine whether it is safe to send patients home from the~     hospital on the same day following an implantable cardioverter defibrillator (ICD) implant.~   "
120227|NCT01993849|"~     To conduct a pilot randomized placebo-controlled feasibility trial of N-acetylcysteine (NAC)~     in onychophagia, preliminarily assessing the tolerability and effects of this pharmacotherapy~     on young adults who bite their fingernails. It is proposed that NAC will help decrease~     fingernail biting.~   "
120231|NCT01993797|"~     To evaluate the correlation between clinical and ultrasound findings in children presented~     with signs suggestive of bronchiolitis and to validate an ultrasound score for bronchiolitis~     that will correlate with specific clinical outcomes.~   "
120232|NCT01993784|"~     Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in~     the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical~     efficacy has been shown in adult with head and neck cancer. The study assessed the safety and~     efficacy of different dosage of Nimotuzumab in second or late- line treatment of patients~     with locally advanced or metastatic esophageal squamous cell carcinomas.~   "
120233|NCT01993771|"~     This is a prospective, observational study, aimed to establish changes of bispectral~     bilateral system in both cerebral hemispheres during a total intravenous anaesthesia during~     breast surgery in the woman. By placing two Bispectral bilateral sensors (BIS), one on both~     frontal lobes, and another on both parietal lobes, we wanted to evaluate differences between~     frontal and parietal areas, when the patient is awake and during the anaesthetic procedure.~   "
120234|NCT01993758|"~     This study aims to determine whether the lower tourniquet pressure, which is set by adding~     120mmHg (millimeter of mercury) on the systolic blood pressure just before tourniquet~     inflation, are efficient and safe during total knee arthroplasty, compared with the~     conventional tourniquet pressure: 150mmHg above the systolic blood pressure before tourniquet~     inflation.~   "
120235|NCT01993745|"~     The study is to show the prognostic factor of HRV parameter and cardiac fibrosis markers in~     critical illness patients~   "
120236|NCT01993732|"~     The purpose of this study is to retrieve and cryopreserve ovarian tissue from females~     undergoing a treatment that may lead to irreversible loss of ovarian function.~   "
120237|NCT01993719|"~     Background:~        -  The NCI Surgery Branch has developed an experimental therapy that involves taking white~          blood cells from patients' tumors, growing them in the laboratory in large numbers, and~          then giving the cells back to the patient. These cells are called Tumor Infiltrating~          Lymphocytes, or TIL and we have given this type of treatment to over 400 patients with~          melanoma.~        -  In this trial, we are determining if there is a difference in the response between~          patients who have received prior anti-PD1 treatment to those who have not received this~          prior ant-PD1 treatment.~      Objectives:~      - To determine if there is a difference in the rate of response between patients who have~     received prior anti-PD1 and those who have not.~      Eligibility:~      - Individuals at least 18 years and less than or equal to 70 years of age who have metastatic~     melanoma.~      Design:~        -  Work up stage: Participants will be screened with a physical exam and medical history.~          Blood and urine samples will be collected.~        -  Surgery: Surgery or biopsy will be performed to obtain tumor from which to grow white~          blood cells. White blood cells will be grown from the tumor in the laboratory.~        -  Leukapheresis: Participants will have leukapheresis to collect additional white blood~          cells. (Leukapheresis is a common procedure which removes only the white blood cells~          from the patient.)~        -  Treatment: Participants will receive standard dose chemotherapy to prepare their immune~          system to accept the white blood cells. Participants will receive an infusion of their~          own white blood cells grown from tumor. They will also receive aldesleukin for up to~          five days to boost the immune system s response to the white blood cells. They will stay~          in the hospital for about 4 weeks for the treatment.~        -  Follow up: Patients will return to the clinic for a physical exam, review of side~          effects, lab tests, and scans about every 1-3 months for the first year, and then every~          6 months to 1 year as long as their tumors are shrinking. Follow up visits take up to 2~          days.~   "
120238|NCT01993706|"~     Background:~      - VRC01 is a manmade antibody directed against the human immunodeficiency virus (HIV).~     Antibodies fight infection. Researchers eventually want to know if VRC01 helps prevent or~     treat HIV infection. In this study they want to know if the study drug is safe if taken in a~     vein or under the skin. Taking VRC01 in this study will not protect against HIV infection.~      Objectives:~      - To see if VRC01 and placebo are safe and well tolerated.~      Eligibility:~      - Healthy adults 18 to 50 years old.~      Design:~        -  Participants will be screened with medical history, physical exam, and lab tests.~        -  Participants will be randomly divided into 4 groups. VRC01 or the placebo will be given~          in weeks 1 and 4. Blood samples will be taken several times after each VRC01 or placebo~          dose.~        -  Three groups will receive VRC01 by needle into a vein with an IV pump. It will take~          about 1 hour and it is done in the hospital.~        -  One group will receive either VRC01 or the placebo by needle into the fatty tissue under~          the skin, usually the belly. It will take up to 20 minutes and it is done in the~          hospital.~        -  Participants will stay in the hospital overnight after receiving the medication and have~          about 14 clinic visits over 4 months. Most clinic visits last about 2 hours.~        -  Participants will keep a symptom diary after receiving the medicatino.~        -  Participants can volunteer to have mouth, rectal, and genital samples taken throughout~          the study.~        -  The study will last 8 months.~   "
120239|NCT01993693|"~     The purpose of this study is to evaluate the ability of a wearable therapeutic ultrasound~     device to reduce pain and increase mobility for subjects with knee osteoarthritis.~   "
120240|NCT01993680|"~     Disabling symptoms of blood pressure dysregulation, impaired swallowing and digestion are~     common amongst Parkinson`s patients. So far the exact pathophysiology for this is not fully~     understood. There are results from pathological analyses that the autonomic nervous system is~     also affected by the accumulation of alpha-Synuclein and that this might even happen in very~     early stages of the disease process (Qualman et al., 1984; Wakabayashi et al., 1989;~     Wakabayashi et al., 1990; Bloch et al., 2006).~      Blood pressure dysregulation is a common autonomic symptom in Parkinson`s patients and~     treatment - currently most often achieved with Fludrocortisone - often leads to supine~     hypertension (Plaschke et al., 1998; Braune et al., 1999; Magerkurth et al., 2005).~      There are studies in patients with autonomic failure that indicate that Pyridostigmine~     bromide might be an alternative treatment option without causing disabling supine~     hypertension (Singer et al., 2003; Sandroni et al., 2005; Singer et al., 2006; Yamamoto et~     al., 2006).~      Delayed gastric emptying is also an autonomic symptom associated with Parkinson`s disease. By~     the elevation of the cholinergic tone with Pyridostigmine bromide the investigators also~     expect to alleviate symptoms of delayed gastric emptying and obstipation, possibly even~     facilitating the uptake of dopaminergic medication through the gut (Sadjadpour, 1983;~     Bharucha et al., 2008).~      Therefore the investigators designed a monocentric randomized, controlled, double blind,~     crossover phase II trial to show non-inferiority of the effect of pyridostigmine bromide vs.~     fludrocortisone on symptoms of autonomic dysregulation in Parkinson`s disease.~   "
120251|NCT01993537|"~     Patients will undergo at baseline and regular intervals:~        -  clinically indicated bloodwork/urine and echocardiogram testing~        -  biomarker studies~      Upon enrolment in the study patients will be divided into 4 groups normal, mildly deficient~     and severely deficient. Normal and mild vitamin D levels will receive no treatment while~     severe Vitamin D deficiency will be randomized (50/50) to receive no treatment or vitamin D~     treatment. They will be seen in the heart failure clinic every 6 months. The patients will be~     followed for 26 months.~   "
120252|NCT01993524|"~     The purpose of this study was to determine whether supplementation of standard antibiotic~     therapy with oral probiotic preparation prOVag containing lactic acid bacteria influences~     recurrence of bacterial vaginosis/vaginitis.~   "
120241|NCT01993667|"~     Acetazolamide, or Diamox, is the standard medical prophylaxis agent for high altitude~     illness. The medication is effective in preventing acute mountain sickness (AMS), high~     altitude pulmonary edema (HAPE), and high altitude cerebral edema (HACE). Its mechanism is~     via inhibition of the carbonic anhydrase enzyme which counteracts the respiratory alkalosis~     which occurs during ascent to altitude. It facilitates the excretion of bicarbonate in the~     urine. As a result, acetazolamide hastens acclimatization and helps prevent high altitude~     disorders.~      Current recommended dosing is 125 mg, orally twice daily, started 24 hours prior to ascending~     in elevation. Side effects include tingling of the fingers and toes and perioral numbness~     which may be erroneously interpreted as stroke symptoms. Since acetazolamide is a mild~     diuretic, frequent micturition may occur leading to interruption of daytime activities as~     well as broken sleep. These effects can affect safety at high altitude. Acetazolamide is~     normally discontinued 2 days after the user has reached their highest elevation or a plateau~     in elevation.~      A lower dose may be just as effective in preventing high altitude illnesses while preventing~     the disconcerting side effects resulting from its use. A smaller dose has not been studied,~     however. We will compare the common dose of 125 mg twice daily with a lower dose of 62.5 mg~     twice daily.~   "
120242|NCT01993654|"~     This study aims to validate the use of laser in vivo confocal microscopy as an early~     diagnostic and differentiation tool of pigmented conjunctival lesions, evaluate the efficacy~     of in vivo confocal microscopy for follow-up (as a visualizing tool) after tumor resection~     for early detection of tumor recurrence, and to evaluate the use of in vivo confocal~     microscopy in evaluation of response to treatment. The modified technique with Heidelberg~     Retina Tomography (HRT) confocal microscopy and anterior segment optical coherence tomography~     (OCT) are non-invasive, no-touch, imaging techniques that may help in differentiation of~     benign lesions like nevi or racial melanosis, from malignant lesions like primary acquired~     melanosis and malignant melanomas. The OCT will potentially allow to estimate tumor depth in~     vivo as preliminary studies have shown.~   "
120243|NCT01993641|"~     The purpose of this open label study is to determine whether combining pracinostat (study~     drug) with Vidaza (azacitidine) or Dacogen (decitabine) will improve clinical responses in~     Myelodysplastic Syndrome (MDS) patients who have failed an initial single agent~     hypomethylating agent (HMA), and to provide additional safety and efficacy data.~   "
120244|NCT01993628|"~     Alzheimer's disease (AD) and Lewy body's dementia (LBD) are two frequent neurodegenerative~     pathologies. They differ in their expression, their evolution but share same features which~     make their diagnosis uneasy.~      Constructional apraxia has been described in both disease.The underlying mechanisms have been~     less studied and could be different in AD and LBD.~      The definition of the constructional apraxia is purely descriptive and few models are~     inconclusive.~      It is admitted that drawing tasks involve visuo-perceptive and visuo-spatial abilities,~     executive functions and working memory as well as purely constructive skills.~      Regarding to different studies, visuo-perceptive abilities are more severely impaired in LBD~     than in AD and are considered as an early onset sign of the disease.~      Executive functions deficits are documented in AD and LDB and could contribute to the drawing~     impairment.~      It is possible to compensate the planning disorders in giving patient the best strategy to~     use.~      If drawing impairment persists, they should result of others mechanisms like~     visuo-perception, visuo-spatial or constructive deficits.~      The investigators suggest that giving the best planning strategy will help more AD patients~     who are supposed to fail in raison of an executive impairment, than the LDB group who is~     supposed to present visuo-perceptive deficits. An MRI will be proposed to study the cerebral~     areas involved in constructional apraxia.~   "
120245|NCT01993615|"~     The purpose of this study is to compare the outcomes for patients that receive two different~     treatments used for FAI (Femoroacetabular Impingement). The programs are 1) a 6-week~     supervised physical therapy program and 2) arthroscopic surgery. Enrollment is limited to~     patients that have already been determined surgical candidates. The study is following~     patients for a 2-year period.~   "
120246|NCT01993602|"~     The lung expansion techniques are widely used to prevent postoperative pulmonary~     complications. However, the effect of each technique on thoracoabdominal mechanics after~     abdominal surgery and if it influences the rate of postoperative pulmonary complications~     remains unknown. The investigators hypothesis is that the lung expansion technique that more~     increases lung volume after abdominal surgery, will be the most efficient in preventing~     postoperative pulmonary complication after abdominal surgery. The investigators objectives~     will be to compare the effect of different lung expansion techniques on lung volumes and~     activation of inspiratory muscle, and prevention of pulmonary complications in patients~     undergoing upper abdominal surgery. This study will involve 171 patients undergoing elective~     abdominal surgery. Patients will be randomly divided into 5 groups: no therapy group (n=35),~     continuous positive airway pressure (CPAP, n=34); volumetric incentive spirometry (VIS,~     n=34); flow oriented incentive spirometry (FIS, n=33) and deep breathing (DB, n=35). The~     thoracoabdominal mechanics will be assessed before and 3 days after surgery. Complications~     will be evaluated by a researcher who did not know to which group each patient belongs.~   "
120247|NCT01993589|"~     Patients frequently experience pain from moderate to severe during gynecologic procedures.~     This study is a prospective, randomized, placebo-controlled trial and aimed to investigate~     the analgesic efficacy of preoperative oral dexketoprofen trometamol, intravenous~     paracetamol, lidocaine spray, pethidine and diclofenac sodium on fractional curettage~     procedure.~   "
120248|NCT01993576|"~     The purpose of this study is to determine if NIF fluoresent imaging is an effctive approch to~     detect the margine of the breast tumoral tissue.~   "
120249|NCT01993563|"~     The aim of the study is to evaluate whether a graded rehabilitation approach including~     Implicit and explicit motor imagery training and mirror therapy is more effective than other~     treatments commonly provided in a neuro-rehabilitation department.~   "
120250|NCT01993550|"~     The goal of this project is to examine the physical and psychological health benefits of a~     novel, telephone-delivered symptom management intervention for advanced lung cancer patients~     and their family caregivers.~   "
121568|NCT01976260|"~     The purpose of this study is to compare the effectiveness of the ePrime fractional~     radiofrequency system to the 1550-nm fractional photothermolysis system (Fraxel) in the~     ability to improve acne scar appearance.~   "
120253|NCT01993511|"~     Besides causing weight loss Roux-en-Y gastric bypass (RYGB) has profound effect on glucose~     metabolism leading to remission of type 2 diabetes early after surgery. However the~     mechanisms for this improvement remain uncertain. The aim of this study is to investigate the~     changes in insulin sensitivity and beta-cell function 1 week and 3 months following RYGB~     using oral and intravenous test.~   "
120254|NCT01993498|"~     The aims of the cohort will be to quantify impact of cancer treatments toxicities , and to~     generate predictors of chronic toxicity in patients with non-metastatic breast cancer.~      The project will include four specific aims :~        1. To develop a database of chronic treatment related toxicity in a cohort of 20 000 women~          with stage I-III breast cancer (= non metastatic), whatever these treatments are~          (surgery; radiation therapy; chemotherapy …)~        2. To describe incidence, clinical presentation, and outcome of chronic toxicities over a~          maximum of 8 years.~        3. To describe the psychological, the social and the economic impacts of chronic~          toxicities.~        4. To generate predictors for chronic toxicities in order to prevent them, based upon~          biological criteria.~      The expected impact of these toxicities, when identified, will be to improve quality of life~     and to decrease health cost, by the early identification of patients at high risk of~     toxicity. Such early identification could lead to prevent toxic effect by: a. developing~     prevention strategies, b. substituting toxic treatment by a non (less) toxic one.~      Also, such cohort will offer a quantification of the impact of treatment toxicity, that could~     be further used to quantify medical usefulness of strategies that aim at decreasing treatment~     toxicities (implementation of predictive biomarker for resistance, cytotoxic-free regimen~     etc…)~   "
120255|NCT01993485|"~     Degenerative aortic valve stenosis (AVS) is the leading cause of aortic valve morbidity with~     a prevalence of 2-7% at ages above 65 years, with ever-increasing incidence especially in the~     8th decades. AVS is independently associated with atheroclerosis risk factors and clinically~     apparent CV disease indicating that the degeneration of the aortic valve may represent an~     atheroclerosis-like process involving both, the aortic valve as well as the vascular system,~     respectivel. It is still unknown whether the endothelial function is affected as an~     manifestation of the atherosclerotic process, changes in the driving mechanical forces as WSS~     downstream of the valve, or other factors beyond physical pressure effects.~      The investigators hypothesized that altered haemodynamics may at least partly be responsible~     for observed endothelial dysfunction in patients with AVS. Therefore, the aim of this study~     is to investigate whether the resolution of AVS by transaortic valve implacement (TAVI)~     affects WSS, improves endothelial dysfunction and decreases levels of circulating EMPs as~     markers of endothelial integrity.~   "
120256|NCT01993472|"~     The purpose of this study is to determine the efficacy and safety of Andrographolides~     combined with Capecitabine in treatment of elderly patients with locally advanced or~     recurrent or metastasis inoperable colorectal cancer~   "
120257|NCT01993459|"~     The purpose of this study is to determine whether Midazolam given pre-operatively to patients~     undergoing abdominal surgery improves the quality of recovery.~   "
120258|NCT01993446|"~     The purpose of this study is to determine whether DRM02 is safe and effective in the~     treatment of rosacea when applied twice daily for 6 weeks.~   "
120259|NCT01993433|"~     The purpose of this study is to determine whether DRM02 is safe and effective in the~     treatment of plaque psoriasis when applied twice daily for 6 weeks.~   "
120260|NCT01993420|"~     The purpose of this study is to determine whether DRM02 is safe and effective in the~     treatment of atopic dermatitis when applied twice daily for 6 weeks.~   "
120261|NCT01993407|"~     The purpose of this research study is to investigate different types of task training to~     determine if training improves thinking processes following traumatic brain injury.~   "
120262|NCT01993394|"~     The primary aim of this project is to get further knowledge on the effects of + Gz~     accelerations and hyperoxia on lung ventilation in humans. The secondary aim is to study lung~     perfusion and cardiovascular function in these conditions.~   "
120263|NCT01993381|"~     The most common toxicity of chemotherapy is nausea and vomiting, and appropriate management~     of these toxicities can help patients improve tolerance for chemotherapy. Anti-emetics~     including dopamine antagonist, serotonin antagonist, and substance P antagonist administered~     to patients according to emetogenic risk of chemotherapeutic drugs. However, patients don't~     always experience same nausea and vomiting for the same drugs. Therefore, it is important to~     determine the biomarker to predict chemotherapy-induced nausea and vomiting. Some biomarkers~     studies were done during the chemotherapy. However it is not definite evidence of relations~     between biomarkers and chemotherapy. We will hope to find any predictive biomarker of CINV.~   "
120264|NCT01993368|"~     Periodontitis are inflammatory diseases characterized by the destruction of the~     tooth-supporting bone due to increased bone resorption by osteoclasts (OCLs). Two forms are~     described: chronic periodontitis (CP) and aggressive periodontitis (AP) that differ by the~     severity and rapidity of bone loss, much more important for AP than CP. In both forms, the~     link with uncontrolled activation of the immune system is largely admitted. Despite the~     physiopathology of CP is fairly well studied, very few data are available regarding AP. The~     investigators aim is to understand the severity of AP by analyzing the proportion and action~     of immune and mesnchymal cells potentially involved in bone destruction, on biopsies of~     periodontal granulation tissue (surgical waste) and blood. Three groups of 20 patients will~     be included: affected with AP, CP or controls (necessitating an extraction of wisdom teeth).~   "
120296|NCT01992952|"~     This is a two stage study, with an initial dose escalation phase I study and subsequent~     double blind randomised phase II controlled trial. Eligible patients are post-menopausal~     women with metastatic ER+ breast cancer not suitable for surgical resection. Patients should~     be suitable for endocrine treatment, but have received no more than 3 previous lines of~     endocrine treatment and up to 1 line of chemotherapy for metastatic disease. They will also~     have had progressive disease during treatment with an aromatase inhibitor. Following the~     dose-escalation in stage 1, patients will be randomised to receive fulvestrant plus either~     placebo or 480mg (or maximum tolerated dose) of AZD5363 oral capsules or tablets taken once~     daily.~      Patients will receive fulvestrant in combination with either placebo or AZD5363 until disease~     progression. Patients may continue to receive fulvestrant and AZD5363/placebo treatment even~     after the last trial visit.~   "
120265|NCT01993355|"~     Introduction: Non-specific chronic low back pain (CLBP) is one of the most frequent causes~     for patient disability and a general recurrent cause for medical consultation with high costs~     to public health. From rehabilitative medicine, physiotherapy is commonly offered. Although~     this treatment is aimed to reduce disability, pain severity and pain-related~     anxiety-depressive symptoms, many patients report partial improvement and recurrent intensive~     and disabling pain episodes. Therefore, a new approach in the treatment and rehabilitation of~     this pathology that takes into account psychosocial aspects that might be modulating pain is~     necessary.~      Material and methods: This project aims to assess the efficacy of two complementary~     interventions to standard physical therapy, such as relaxation techniques and~     cognitive-behavioral intervention, to improve health-related quality of life (HRQoL) among~     patients with CLBP. It is hypothesized that groups receiving these complementary~     interventions will significantly improve their adherence to physiotherapy and the control of~     their pain and, ultimately, these aspects will facilitate a decreasing of pain intensity and~     better HRQoL.~      For these purposes, a pre-post longitudinal design will be carried out, with follow-up~     assessments at 6 and 12 months in a sample of 66 participants. This sample will be divided~     into: control group (physiotherapy), intervention group 1 (physiotherapy and relaxation~     techniques-sophrology) and intervention group 2 (physiotherapy and cognitive-behavioral~     intervention).~      Expected impact: Study results are not available yet. However, if working hypotheses are~     confirmed, a multidisciplinary model of care for CLBP will be empirically justified. This~     approach is expected to benefit HRQoL among these patients implying a significant short-mid~     term reduction of public health costs.~   "
120266|NCT01993342|"~     The purpose of this study is to determine the concentration of different adipocytokine~     (adiponectin, leptin, resistin, visfatin, osteopontin) and an inflammation classic markers as~     Interleukine 1 beta, tumor necrosis alfa, interleukine 6 and high sensibility reactive c~     protein in the synovial fluid of knee osteoarthritis patients, and compare with the~     inflammation detected with ultrasonography evaluation of the joint. In last years, some~     studies appeared focusing on the role of adipocytokines in osteoarthritis and they correlated~     adipocytokines with cartilage degradation and x-ray degree; in our study we will focused in~     the importance of adipocytokines in the inflammatory changes more than in joint destruction.~   "
120267|NCT01993329|"~     This is a randomised, double blind, double-dummy, placebo-controlled, three way crossover,~     single centre study in subjects with asthma undergoing inhalation of methacholine and ATP to~     assess the PC20 response of two dose levels of gefapixant (AF-219) compared with placebo.~   "
120268|NCT01993316|"~     Neurofeedback can be described as a form of biofeedback which is based on recording brain~     activity; usually by using scalp EEG. Neurofeedback has been used for 40 years as a~     therapeutic treatment for many neurological conditions including epilepsy, attention deficit~     hyperactivity disorder and also to improve mental performance in healthy subjects.~     Participants can see their brain activity via the EEG readings and receive positive~     feedback (visual or auditory) to help them consciously shape their brain waves into the~     desired patterns.~      sLORETA, which is speciliazed computer program to analyze EEG results, will be used in~     conjuntion with EEG to study the effect of neurofeedback on the brain activity of healthy~     subjects.~      In this study we will investigate the effect of neurofeedback training using sLORETA, which~     is a specific method to measure brain waves. We will measure the effect on both brain~     hemispheres both before and after neurofeedback training.~   "
120269|NCT01993303|"~     Lowering the per-infusion dose of Rb-82 offers advantages of lessening radiation exposure and~     extending useable generator life. Prior studies have not shown equivalence of 3D vs 2D Rb-82~     PET. The investigators therefore compare 3D PET after a lower Rb-82 dose (~20 mCi) processed~     using a Monte-Carlo driven scatter correction algorithm against conventional higher dosage~     (~50 mCi) 2D Rb-82 PET MPI.~   "
120270|NCT01993290|"~     Ultrasound-guided (USG) brachial plexus (BP) block efficacy at the Supraclavicular (SCL),~     Lateral- Infraclavicular (LIC) and Axillary (AX) level: Randomized, observer-blinded study of~     the single-penetration multiple-injection-technique.~   "
120271|NCT01993277|"~     The study is an open-label comparative effectiveness clinical trial evaluating the impact of~     three neuromodulation treatment devices to improve the mental health and sobriety status of~     recovering substance abuse patients. We intend to enroll 200 patients to give us a sufficient~     number of subjects for the planned comparisons. Following informed consent and baseline~     assessment, patients will be randomly assigned to receive either 1) 15 40-minute sessions of~     Nexalin Brain Stimulator, a cranial electrical stimulation (CES) device, once-per-day within~     a 3-week time-frame; 2) 30 20-minute sessions of the Fischer Wallace Stimulator, another CES~     device, twice-per-day within a 3-week time-frame; 3) 15 40-minute sessions of the DAVID~     Delight, an audio-visual stimulation device (AVS), once-per-day within a 3-week time-frame;~     OR 4) the control-group condition of 15 40-minute relaxation therapy sessions once-per-day~     within a 3-week time-frame. All subjects will then be reassessed at the end of the 3 weeks of~     treatment and again 1, 3, and 6 months later. In addition to the assigned treatments, all~     patients will also receive the standard array of services that are provided by Behavioral~     Health of the Palm Beaches (BHOPB) including as clinically appropriate, psychiatric~     medication management and Eye Movement Desensitization Response (EMDR) therapy. Patients~     diagnosed with Post Traumatic Stress Disorder (PTSD) are assessed to determine their~     suitability for EMDR and if suitable, will receive 2 or more EMDR sessions. Patients without~     PTSD do not receive EMDR therapy.~   "
120272|NCT01993264|"~     Cardiac disease in children may start early in life and evidence of cardiac disease can be~     seen during prenatal life. A variety of diseases diagnosed during fetal life can put children~     at risk for cardiac disease. The accurate assessment of cardiac function is important in~     these patients. A type of imaging scan called fetal echocardiogram is used to measure the~     contractility or squeeze of the heart. The fetal echocardiogram is a painless test and~     completely non-invasive.~      This study aims to recruit women and fetuses to determine if this imaging scan can be used~     throughout the pregnancy to measure heart squeeze and develop normal values to help doctors~     better diagnose fetuses who may have cardiac disease before they are born.~   "
120305|NCT01992835|"~     After an allergen challenge, the allergic inflammatory response disappears spontaneously. The~     initiation of the resolution of the inflammatory response is now recognized as a dynamic~     process, involving active biochemical programs that enable inflamed tissues to return to~     homeostasis. Recent data established key roles of different specific lipid mediators in the~     endogenous counter-regulation of inflammation and activation of resolution. Only little is~     known about kinetics of these specialized pro-resolving lipid mediators during acute allergic~     inflammation. Therefore, the primary propose of our study is to characterize the temporal~     evolution of cellular inflammation and specific lipid mediators after allergen challenge.~   "
121569|NCT01976247|"~     The purpose of this study is to compare the safety and effectiveness of the Zeltiq System and~     LipoSonix System for fat reduction and improving body shape.~   "
120273|NCT01993251|"~     Although behavioral disorders origins in autistic children are still unclear, they seem to be~     influenced by sleep disorders. Results of studies performed on sleep quality in autistic~     children showed a high prevalence of sleep disorders in these children, estimated between 50~     and 80% compared to children with typical development and insomnia is one of the sleep~     disorders most frequently reported by autistic children's parents. Others studies showed~     circadian rhythm disorder in autistic children which could be the consequence of genetic~     abnormalities in the melatonin synthesis and the melatonin role in the synaptic transmission~     modulation.~      Melatonin by its sedative effects and its action on circadian pacemaker is a promoter of~     sleep proposed for insomnia treatment and circadian rhythm disorders.~      Two major recent studies (not yet published) in the United States and in England seek to show~     the effectiveness of melatonin by testing the effects of three doses of melatonin on reducing~     sleep disorders.~      It is therefore interesting and important to conduct a parallel study to assess the melatonin~     effect not only on the reduction of sleep disorders (sleep onset latency, total sleep time…),~     but on sleep quality (number of nocturnal awakenings).~      The strength of this study lies in the combination of several measurement tools to assess the~     melatonin dose-effect on all parameters in both physiological (actimetrics, polysomnography),~     biological (dosage 24h sulfatoxymelatonin), behavioral (sleep questionnaire, index of~     insomnia severity, rating scale autistic disorder) as well as possible side effects.~      The primary objective is to determine the most effective dose of melatonin to improve sleep~     quality in autistic children.~   "
120274|NCT01993238|"~     The objectives of this study are to evaluate the safety and effectiveness of procedural~     analgesia for improvements in tolerability of treatment with the Liposonix System.~   "
120275|NCT01993225|"~     This is a Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men~     with Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm~     Concentration Following Treatment with 12.5 mg or 25 mg Androxal or AndroGel 1.62%.~   "
120276|NCT01993212|"~     This is a Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men~     with Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm~     Concentration Following Treatment with the 12.5 mg or 25 mg Androxal or AndroGel 1.62%.~   "
120277|NCT01993199|"~     Upper gastrointestinal subepithelial tumors are frequently encountered during~     esophagogastroduodenoscopy. Treatment plans for subepithelial tumors are determined by~     algorithms based on endoscopic ultrasonography images. However, endoscopic ultrasonography~     alone may not be able to diagnose and evaluate upper gastrointestinal SETs with sufficient~     accuracy. Adequate tissue samples are required to increase the diagnostic accuracy of~     subepithelial tumors.~      Deep biopsy is method that normal mucosa was dissected using enodsocpi submucosal dissection~     technique and multiple endoscopic biopsies were performed.~      The investigators will perform deep biopsy in subepithelial tumor.~   "
120278|NCT01993186|"~     UX007 is more effective than placebo for the reduction of seizures in patients with Glut1 DS,~     as measured by the reduction from baseline in frequency of generalized or partial-onset~     seizures, including: Generalized Tonic-Clonic, Generalized Tonic, Generalized Clonic,~     Generalized Atonic, Partial/Focal with Secondary Generalization, Myoclonic, Myoclonic Atonic,~     Myoclonic Tonic, Complex Partial/Focal, Absence and Simple Partial/Focal Motor seizures~   "
120279|NCT01993173|"~     The aim of the study is to assess the immunogenicity and safety profile of ADACEL compared to~     local adsorbed diphtheria and tetanus combined vaccine (local DT or local Td vaccine in~     participants in China.~      Primary objective:~        -  To describe diphtheria and tetanus seroprotection rates and pertussis booster response~          rates induced by each of the study vaccines: ADACEL vaccine (in all study age groups),~          local DT vaccine (in children), and local Td vaccine (in adolescents and adults).~      Secondary Objectives:~        -  To further describe in each group the immunogenicity of the study vaccines at baseline~          and 1 month after vaccination.~        -  To describe the safety of the study vaccines~   "
120280|NCT01993160|"~     This is a single centre, single arm feasibility study of 18FCH PET-MR imaging for staging~     patients with high risk prostate cancer.~      Study Hypothesis:~      FCH-PET/MR will enable more accurate staging of patients with high risk prostate cancer as~     compared to conventional imaging.~   "
120281|NCT01993147|"~     The purpose of this study is to learn more about the brain circuits involved with effortful~     control in healthy adult participants. Study participants will be given either~     methylphenidate (also known as 'Ritalin')which is an FDA approved, most widely-used~     medication given to those diagnosed with Attention Deficit Hyperactivity Disorder (ADHD)or a~     placebo, which is a sugar pill. Each participant will also perform some computer tasks that~     have been shown in previous studies to require effortful control while undergoing an fMRI~     (functional Magnetic Resonance Imaging) which takes a special kind of picture of the brain.~     Our goal is to learn more about the brain mechanisms by which methylphenidate improves~     effortful control.~   "
120282|NCT01993134|"~     The study set out to evaluate the efficacy of two antibiotic prophylaxis regimens in patients~     with facial fractures admitted to the Oral and Maxillofacial Surgery and Traumatology~     services of the Onofre Lopes University Hospital attached to the Federal University of Rio~     Grande do Norte.~   "
120283|NCT01993121|"~     The objective of the current proposal is to evaluate the importance of blood vessel~     dysfunction and heart dysfunction to overall exercise impairments in type 2 diabetes and~     their contribution to the gender differences observed in exercise capacity. Importantly,~     treatments that improve blood vessel function in persons with type 2 diabetes can be used to~     directly assess whether impairment in blood vessel function and ultimately exercise~     performance, can be improved and whether the degree of improvement differs between the sexes.~      Hypothesis 1. Uncomplicated type 2 diabetes more adversely affects exercise capacity in women~     than men.~      Hypothesis 2. Blood vessel function and cardiac function are more significantly impaired in~     women with type 2 diabetes than men and contribute to the gender differences in exercise~     capacity.~      Hypothesis 3. Restoration of blood vessel function will improve exercise capacity more in~     women than men with type 2 diabetes.~   "
120324|NCT01992588|"~     This trial is conducted in Europe. The aim of the trial is to compare the pharmacokinetic~     (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the~     investigated drug on the body) properties of FIAsp (faster-acting insulin aspart) and insulin~     aspart (NovoRapid®) given as a bolus on top of a basal continuous subcutaneous insulin~     infusion (CSII).~   "
120284|NCT01993108|"~     The goal of this research is to understand the functioning of 'regulatory circuits' in the~     brain. These are brain circuits which allow a person to regulate their attention, regulate~     their behavioral responses, and regulate their decision-making. We are also interested in how~     the stimulant medications methylphenidate and naltrexone affect these regulatory circuits.~     Methylphenidate is a widely-used, FDA approved medication used to treat Attention Deficit~     Hyperactivity Disorder (ADHD) and is also known as Ritalin. Naltrexone is an FDA approved~     medication used to help treat alcohol and substance abuse.~      This research study will use a scanning technique known as functional magnetic resonance~     imaging (fMRI)which takes a special kind of picture of the brain that enables us to see the~     brain at work. Adult participants will be given a one-time dose of either methylphenidate,~     naltrexone,or placebo before each fMRI scan session. There are three total fMRI scan~     sessions. Therefore, each participant will receive each possible medication/placebo only~     once.~      Thus, using the fMRI technique, our main purpose for this research is to better understand~     the functioning of regulatory circuits in conditions such as ADHD and alcohol dependence.~     This research may one day help us develop better treatments for these disorders.~   "
120285|NCT01993095|"~     The purpose of this study is to test the effectiveness of a DVD-delivered, home-based~     six-month physical activity intervention for people with Multiple Sclerosis.~   "
120286|NCT01993082|"~     The purpose of this study is to determine whether an aerobic training intervention will alter~     markers of immune cell aging, improve exercise capacity and blood pressure and decrease~     psychological distress over 24 weeks in 32 caregivers compared to 32 age-matched wait list~     control caregivers.~   "
120287|NCT01993069|"~     The objective of the study is to evaluate the efficacy of a yoga treatment for veterans with~     mild post-traumatic and chronic tension-type headaches.~      Study Aims:~        -  Does this yoga treatment, targeted toward specific symptoms veterans with mild~          post-traumatic and chronic tension-type headaches experience, assist in decreasing~          headaches and associated symptoms?~        -  Does this yoga treatment, targeted toward specific symptoms veterans with mild~          post-traumatic and chronic tensions-type headaches experience, assist in improving~          quality of life?~        -  Does this yoga treatment, targeted toward specific symptoms veterans with mild~          post-traumatic and chronic tension-type headaches experience, improve mood?~        -  Do the effects of yoga on symptoms, mood, and quality of life maintain 2 months post~          completion of treatment?~   "
120288|NCT01993056|"~     According to available data the injury rate in male veteran soccer is high. Interventions to~     prevent injuries are requested. The 11+ warm-up program was developed by FIFA-experts and~     consists of several exercises with an overall-length of about 20 min. This study shall~     investigate the influence of 11+ on injury incidence and Functional Movement Screen~     (FMS)-Score in male veteran soccer players. Additionally it is to be examined if there is a~     relationship between FMS-Score and injury incidence. For this purpose the 11+-program is~     accomplished under supervised conditions over one regular season in a randomized-controlled~     study design. Injuries are documented via questionnaires in accordance with the~     FIFA-consensus-statement. FMS-Score is evaluated before and after the interventional period.~   "
120289|NCT01993043|"~     Retinopathy of prematurity (ROP) is a leading cause of childhood blindness. Vascular~     endothelium growth factor (VEGF) is an important component of this disease. The goal of~     treatment is to reduce the production of VEGF in the immature retina and to eliminate the~     abnormal growth of new vessels. Currently, laser photocoagulation of the peripheral avascular~     retina is the treatment standard. Intravitreal injection of anti-VEGF antibody Bevacizumab~     (IVB) has been used clinically off-label as an alternative therapy. However, VEGF is~     important for the development of neurons and vessels in the systemic organs in premature~     infants. Pharmaceutical study showed that IVB was absorbed into the bloodstream. It is~     unclear if the systemic absorption of Bevacizumab is dose related, and the short and longterm~     effects on ocular and systemic systems, especially neurological development. In this study,~     our goals are to establish the pharmacokinetics of Bevacizumab in the premature infant and to~     compare the short and long-term vision and neurodevelopmental outcomes of infants treated~     with IVB compared to laser ROP.~   "
120290|NCT01993030|"~     The purpose of the study is to evaluate the safety and effectiveness of HQ® Matrix Medical~     Wound Dressing for repair of donor site wounds. Half of participants will receive HQ® Matrix~     Medical Wound Dressing, while the other half will receive Sidaiyi® wound dressing.~   "
120291|NCT01993017|"~     The purpose of this study is to examine, in a randomized controlled trial, the benefits and~     costs of the American Heart Association's (AHA) advisory for depression screen and treatment~     of post-acute coronary syndrome patients.~   "
120292|NCT01993004|"~     MicroRNAs regulate gene expression. The abnormal expression of microRNAs has been reported in~     many human diseases. The purpose of this pilot study is to determine if microRNA expression~     is changed in untreated and glatiramer acetate-treated patients with multiple sclerosis.~   "
120293|NCT01992991|"~     The purpose of this study is to investigate the effect of transcranial stimulation for upper~     limb training of patients with sequelae from an intracranial hemorrhage.~      Patients receive five days of upper limb occupational therapy training in combination with~     real or sham stimulation. Patients complete the Jebsen Taylor Hand Function Test before,~     after and 7 days later. The intervention takes place at patients' home address.~   "
120294|NCT01992978|"~     Surgical resection is the most effective treatment of primary and secondary liver tumors.~     Technical innovations have mainly focused on minimizing bleeding during transection of the~     hepatic parenchyma because excessive hemorrhage and the need for blood transfusion are~     associated with increased postoperative morbidity and mortality.~     Recently,radiofrequency-assisted（RFA）hepatectomy has developed rapidly and gained widespread~     acceptance for the treatment of hepatocellular carcinomas（HCC），but its influence on the~     prognosis of HCC patients，especially for those with cirrhosis，is still controversial.~     Therefore, we design this prospective clinical trial to explore the effect of RFA hepatectomy~     versus the conventional hepatectomy on the outcomes of perioperative period and prognosis of~     HCC patients with cirrhosis.~   "
120295|NCT01992965|"~     The purpose of the study is to evaluate the effect of real-time continuous glucose monitoring~     system on glucose control and outcomes of critically ill patients.~   "
120297|NCT01992939|"~     This is the second part of a research study in order to determine if using a specialized~     pulse oximetry probe with external heat pack will help obtain oxygen saturation (SaO2) and~     heart rate (HR) during monitoring for patients with peripheral vascular disease (PVD),~     vasoconstriction, and hypothermic extremities. The inability to obtain accurate SaO2 and~     pulse readings can lead to misdiagnosis, incorrect treatment, or procedures to be canceled.~     SaO2 and pulse readings are important to maintain patient stability during diagnostic~     testing, surgical procedures and monitoring while in critical care areas. Changes in SaO2 and~     pulse are important to monitor in order to be able to compensate for any decrease in patient~     oxygen saturations during hemodynamic monitoring.~      The primary aim of this study is to determine if using a specialized pulse oximetry probe~     with external heat pack will improve oxygenation readings in order to obtain SaO2 and pulse~     readings in patients with PVD, vasoconstriction, and hypothermic extremities as compared to~     readings obtained from an arterial blood gas.~      The hypothesis is using a specialized pulse oximetry probe with external heat pack will help~     obtain more accurate pulse oximetry readings consistent with values obtained with an arterial~     blood gas.~   "
120298|NCT01992926|"~     Anemia is a common complication of chronic kidney disease (CKD). In anemia of chronic kidney~     disease, patients suffer from low hemoglobin levels, which contribute to feelings of malaise~     and fatigue. The current accepted practice is often to administer erythropoietin-stimulating~     agents (ESAs), which act like the body's natural hormones to stimulate the production of red~     blood cells from bone marrow. Although ESAs are widely used in CKD, recent evidence suggests~     that they are not as safe as previously thought. In this study, we seek to test a decision~     aid to be used when a patient visits his or her nephrologist at Vanderbilt. The objective of~     the decision aid is to reduce patient confusion, improve their satisfaction with their care,~     improve their knowledge of kidney disease, and ultimately bring more clarity to patients~     about a controversial but ubiquitous drug.~      The decision aid will be about 1 page long and will include questions and information that~     might help the patient be more active and informed regarding the choice of a course of ESA~     therapy. We will ask patients to answer questions before and after their clinic visits~     regarding their satisfaction and confidence in their treatment and their knowledge of kidney~     disease; we will ask some of the same questions 3 months after the clinic visit. We will~     compare patients who are counseled using the decision aid to patients who are not. We~     anticipate total experiment running time to be approximately 5 months to recruit and follow~     up on all patients.~   "
120299|NCT01992913|"~     Schizophrenia/Schizoaffective Disorder is associated with serious problems with cognitive~     skills, social skills, and functional skills (like employment). There is a new form of~     cognitive behavioral therapy called integrated cognitive behavioral therapy (iCBT) that~     specifically addresses the cognitive, social, and functional deficits of~     schizophrenia/schizoaffective disorder. This study is to compare iCBT to the usual care (UC)~     that Veteran's receive. The investigators will compare iCBT to UC in subjects with~     schizophrenia/schizoaffective disorder who are enrolled in a Supported Employment (SE)~     program, and evaluate whether iCBT is more helpful in improving job performance, and other~     areas of functioning, both right after treatment, and 6 months after the end of treatment.~   "
120300|NCT01992900|"~     There is a need for paediatric formulations that permit accurate dosing and enhance patient~     compliance. However, for the treatment of malaria, scarce paediatric-friendly formulations~     are available on the market. Thus, a new water dispersible formulation of eurartesim has been~     developed for oral administration.~      Aim of this study is to provide data on pharmacokinetic profile, safety and efficacy of this~     new paediatric formulation and compare it with the crushed film coated tablet in infant~     patients (6 to ≤12 months of age) suffering from uncomplicated Plasmodium falciparum malaria.~      Furthermore, a Pharmacokinetic/Pharmacodynamic(PK/PD) modelling will be built up to establish~     PK/PD relationship in adult and paediatric populations.~   "
120301|NCT01992887|"~     Retention of patients in HIV care following diagnosis and enrollment is critical to the~     long-term success of HIV care and treatment scale-up. The goal of this study is to better~     understand the factors that influence retention and engagement in HIV care among adult~     patients who are enrolled in HIV care and are not yet eligible for antiretroviral therapy~     (ART). The study will be conducted at four HIV care and treatment clinics (CTCs) in Kagera~     Region, Tanzania. This is a mixed-methods study with both qualitative (interviews) and~     quantitative (surveys) data collection. Our findings will be important towards designing~     programs that help patients remain in HIV care.~   "
120302|NCT01992874|"~     This is a Phase 1, multi-center, open-label, single-dose, 2 period, 2 sequence cross-over~     trial to investigate the relative bioavailability of 2 solid oral pimasertib formulations in~     cancer subjects (Part A), followed by open-label pimasertib administration (Part B and trial~     extension phase).~   "
120303|NCT01992861|"~     This clinical trial studies magnetic resonance imaging (MRI) and positron emission tomography~     (PET) imaging in predictive treatment response in patients with stage IB-IVA cervical cancer.~     MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used~     to create detailed pictures of areas inside the body. PET is a procedure in which a small~     amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make~     detailed, computerized pictures of areas inside the body where the glucose is taken up.~     Comparing results of diagnostic procedures, such as MRI and PET, done before, during and~     after radiation and chemotherapy may help doctors predict a patient's response to treatment~     and help plan the best treatment.~   "
120304|NCT01992848|"~     Coronary artery disease (CAD) remains the leading cause of mortality in the UK with an~     estimated 80,000 fatalities in 2010. Coronary artery calcification (CAC) is associated with~     atherosclerotic plaque burden and cardiovascular mortality. Mechanisms underlying isolated~     CAC have not been as yet been fully explained. MicroRNAs (miRNAs), known to act as regulators~     of gene expression, have also emerged as powerful biomarkers in the diagnosis and prognosis~     of cardiovascular disorders and may be used in the detection of CAC. We aim to investigate~     the potential for a microRNA-signature in patients with CAC by performing a prospective,~     case-controlled study to identify pathways associated with CAC in humans. Previous research~     has demonstrated an inverse relationship between CAC and bone mineral density (BMD),~     suggesting that these processes may be linked. In a further substudy we plan to define the~     relationship between CAC and BMD as well as a number of markers of bone metabolism.~   "
120306|NCT01992822|"~     The principal study aims at evaluating the efficiency of rTMS maintenance sessions on the~     clinical effect of a rTMS cure in fibromyalgic subjects. This complementary study consists in~     the evaluation of the experimental sensitivity to mechanical pain (pressure application on~     the forearm) of subjects presenting fibromyalgia before and after rTMS treatment (21 days),~     and to put the results in relation to the clinical improvement and the psychometric~     evaluations (depression,fibromyalgia impact questionnaire, catastrophism).~   "
120307|NCT01992809|"~     Nonalcoholic fatty liver disease (NAFLD) is a clinical and pathological condition, whose~     spectrum can range from steatosis to steatohepatitis and cirrhosis, in patients without a~     history of alcohol abuse. Nonalcoholic steatohepatitis (NASH), the severe form of (NAFLD),~     has emerged as a clinically important type of chronic liver disease in industrialized~     countries and is characterized pathologically by hepatocellular ballooning, Mallory's~     hyaline, scattered inflammation and perisinusoidal fibrosis. NASH associated with cirrhosis~     can decompensate into subacute liver failure, progress to hepatocellular cancer and reoccur~     post transplantation.In the absence of established treatment, therapy is generally directed~     to treatment of risk factors for metabolic syndrome. Recently, some studies have been~     demonstrated that Polyunsaturated fatty acids (PUFAs), omega3 type, could reduced TNFalfa,~     IL6, aminotransferases, insulin resistance and steatosis verified by ultrasound. Neverthless,~     this is the first study that evaluate liver histology after six months of PUFA (omega3) in~     the treatment of patients with NASH.~   "
120308|NCT01992796|"~     The investigators propose a clinical study of irbersartan for the early treatment of severe~     sepsis patients with elevated predicted risk of death between. This study will evaluate~     whether early administration of the the angiotensin receptor blocker irbersartan provides~     significant reduction of 28 days mortality and multi organ failure incidence to patients with~     severe sepsis.~   "
120309|NCT01992783|"~     The aim of this study is to evaluate whether supplementation with resistant starch improves~     biomarkers associated with antioxidant status and insulin resistance in subjects with~     overweight and obesity.~   "
120310|NCT01992770|"~     Background:~      This study is based on an innovative stepped-care protocol for the management of~     musculoskeletal pain in primary care, which is evaluated in a RCT. The intervention have two~     core features: it is theory-driven and include systematic tailoring of treatment content. The~     tailoring is based on a combination of empirically supported behavioural and medical~     determinants of pain-related disability and patients' individual perceptions on personal~     goals, facilitators and barriers for health behavior change. In this application, the~     intervention is labelled tailored behavioural medicine intervention (TBM).~      Objectives:~      The aim is to compare effects and cost-effectiveness of a stepped care model including advice~     and tailored behavioral medicine pain treatment (experimental condition) with a stepped care~     model including advice and physical exercises (comparison condition) for patients with low~     back and neck pain and/or widespread pain including fibromyalgia in primary care. A further~     aim is to characterize patients who benefit/do not benefit from the respective steps i.e.~     treatments varying in dose and content.~      Methods:~      A stratified randomized stepped care design is applied. Stratification is based on primary~     care center and patient risk profile. A consecutive selection is performed at primary care~     centers in southern, central and northern Sweden. According to power analysis, 364~     participants should be recruited to allow for sub-group analyses. After having received a~     minimal intervention (step 1) comprising 'stay-active advice', participants scoring >90 on~     the Örebro Musculoskeletal Pain Questionnaire (ÖMPQ) are randomly allocated to an eight-week~     treatment in step 2. The experimental condition includes supervised physical exercises~     integrated with either (a) graded activity, or (b) hierarchical graded exposure depending on~     risk profile, i.e. absence or presence of pain catastrophizing and fear-avoidance beliefs.~     The comparison condition includes supervised physical exercises irrespective of risk profile.~     Primary outcome is pain-related disability complemented with a comprehensive set of secondary~     outcomes adhering to the IMMPACT recommendations. Assessments will be made by personnel~     blinded for treatment condition at baseline, after step 1 and 2 respectively, and at 12- and~     24-month follow-ups.~   "
120311|NCT01992757|"~     This study hopes to determine if thromboelastography-derived functional fibrinogen (TEG-FF)~     levels on cardiopulmary bypass during cardiac surgery can provide information on coagulation~     status sooner, allowing for anticipation of post-bypass bleeding and transfusion requirements~   "
120312|NCT01992744|"~     The purpose of this study is to evaluate the correlation between varying levels of~     neuropeptides and birth outcomes. Neuropeptides are substances (proteins) produced in the~     body in very small amounts but without which the nervous system cannot function properly, and~     which might have a role in the health of a newborn. As part of this study, we are collecting~     blood samples from pregnant women.~      Neuropeptides and hormones can be measured in blood. This study will involve three blood~     draws from the participants arm. Demographic information will also be requested, and~     participants will be asked to complete questionnaires about their mood and personal~     experiences at each visit.~      Our hypothesis is that participants with lower levels of brain-derived neurotrophic factor~     (BDNF) will be at increased risk for poor birth outcomes.~   "
120313|NCT01992731|"~     Prospective randomised controlled trial: 3 IUI cycles versus 1 IVF/ICSI cycle in women aged~     38-42 years.~   "
120314|NCT01992718|"~     To improve the clinical care of women with pelvic pain and abnormal uterine bleeding due to~     benign uterine conditions including leiomyomas (uterine fibroids) and adenomyosis by~     evaluating the accuracy of radiology diagnostic exams (MRI(magnetic resonance imaging),~     ultrasound and ultrasound with elastography).~   "
120315|NCT01992705|"~     Primary Objective: To determine the rate of downstaging to resectability in patients with~     borderline resectable pancreatic cancer receiving FOLFIRINOX and SBRT as preoperative~     therapy.~      Secondary Objective(s):~        1. To assess the disease-free-survival, overall survival, time to recurrence and site of~          recurrence in patients with borderline resectable pancreatic cancer receiving~          preoperative FOLFIRINOX followed by SBRT~        2. To investigate the safety and tolerability of FOLFIRINOX and SBRT in patients with~          resectable pancreatic cancer~        3. To determine the radiologic and pathological response associated with preoperative SBRT~          and FOLFIRINOX therapy~        4. To assess quality of life through and after treatment using the FACT-Hep questionnaire~   "
120337|NCT01992419|"~     The purpose of this study is to measure an improvement in the detection rate of cardiac~     arrest (CA) in the Dispatch Center as a result of debriefings and repeated trainings for~     non-medical operators who receive emergency calls.~   "
120454|NCT01990872|"~     This winter-based placebo-controlled, single-dose vitamin D randomized controlled trial (RCT)~     aims to examine the impact of various levels of habitual calcium intake on dietary vitamin D~     requirements in older adults stratified by calcium intake. This will provide new data on the~     impact of different levels of calcium intake, ranging from low/moderate to high, on winter~     serum 25(OH)D levels, and their utilization and catabolism in adults.~   "
120455|NCT01990859|"~     The purpose of this study is to assess the safety of Ipilimumab monotherapy in Japanese~     subjects with advanced melanoma~   "
120316|NCT01992692|"~     Parkinson's disease (PD) is one the main neurodegenerative disease with an incidence of about~     3% in patients older than 65 years. Anesthesia in PD patients has been focused by several~     studies for concerning the interactive reaction between anesthetics and anti-Parkinsonian~     medication or Parkinsonian symptoms. However, our previous experience showed that the~     patients undergoing pulse generator placement were more prone to be involved in delayed~     emergence in the recovery room, which had been not reported yet. We speculated that PD~     patients might be a special population with abnormal pharmacodynamic characters of~     anesthetics, though no related evidence could be found to support this hypothesis. Therefore,~     in this project we investigated whether remifentanl requirement to inhibit patients' response~     to trachea intubation and skin insertion in PD patients undergoing DBS and pulse generator~     placement was different from non-PD patients undergoing intracranial surgery for reasons~     other than PD.~   "
120317|NCT01992679|"~     There is growing evidence that exercise-based rehabilitation results in improvements in~     mobility and participation in persons with multiple sclerosis (MS). However, the vast~     majority of the scientific evidence in support of this view is based on persons with MS who~     have minimal mobility impairment. This is partially due to the lack of accessible exercise~     equipment and facilities available to persons with severe mobility limitations.~      One option available to persons with severe mobility limitations is body weight supported~     treadmill training. Indeed, this rehabilitation approach has been utilized with some success~     in various clinical populations, such as stroke and spinal cord injury, and is believed to~     target neuroplasticity. Specific to persons with MS, body weight supported treadmill training~     has shown great promise in improving quality of life, symptoms and functional mobility in two~     small (n=4 and n=6) pilot investigations. However, previous research has been hampered by~     methodological limitations including small sample size, lack of a control group and limited~     training sessions. Consequently, no firm conclusion regarding the benefit of body weighted~     supported treadmill training in persons with MS can be drawn. The proposed project seeks to~     determine if twenty-weeks of body weight supported treadmill training leads to improvements~     in physiological function, mobility and quality of life in persons with MS with severe~     mobility limitations. The outcomes of this project have the potential to lead to new~     rehabilitation approaches capable of improving function and quality of life in persons with~     advanced MS.~   "
120318|NCT01992666|"~     Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease for which the aetiology~     includes genet-ic and environmental factors. It is rare in children as compared to adults.~     The severity may be related to greater involvement of genetic factors in children. The impact~     of genetics in the development of SLE is important, and the risk of recurrence in siblings~     evaluated by lambda S ratio is 30 in SLE, while it is 15 for type-1 diabetes and 8 rheumatoid~     arthritis, thereby indicating high impact of genetics in SLE.~      Recently, the group of Professor Yanick Crow in Manchester and other teams has identified new~     forms of lupus Mendelian genetics. The TREX1 and genes involved in the SAMHD1 frostbite~     lupus.~      Nearly 2 % of all adult subjects with SLE have a heterozygous mutation in the TREX1 gene,~     which therefore represents the first genetic cause of SLE. The team of Professor Crow also~     identified the ACP5 gene that is responsible for SLE associated with Spondylo-epiphyseal~     enchondro-epiphyseal dysplasia (syndromic lupus). Other groups have identified mutations in~     two genes encoding a DNAse (DNAse1 and DNAse1L3) responsible for familial monogenic forms of~     SLE. These new genes SLE were identified through research of germ-line mutations in cases of~     lupus syndromic or family. In collaboration with Professor Crow, we are currently undergoing~     characterization of a novel gene of SLE in a family and we have identified a second locus~     identified in another family. The identification of these genes provides a better~     understanding of the mechanisms regulating immune tolerance in humans. The frequency of these~     genetic forms is not known. There is very little data on the immunological phenotype of these~     patients.~      This is a clinical study to investigate the genetic and immunological abnormalities~     associated with pediatric SLE. The aim are to:~        -  study the genetics of pediatric SLE (or syndromic or family) and to search for mutations~          in the known genetic lupus or new genes in collaboration with Professor Yanick Crow.~        -  study the lymphocyte subpopulations and serum cytokines in pediatric patients with SLE~          (or syndromic or family) in the large Rhône- Alpes- Auvergne area.~   "
120319|NCT01992653|"~     This multicenter, open-label, dose-escalation study will evaluate the safety, tolerability,~     pharmacokinetics, and anti-tumor activity of polatuzumab vedotin in combination with~     rituximab or obinutuzumab, cyclophosphamide, doxorubicin, and prednisone (CHP chemotherapy)~     in participants with non-Hodgkin's lymphoma (NHL). Participants will receive escalating doses~     of polatuzumab vedotin intravenously (IV) every 3 weeks in combination with standard doses of~     rituximab plus CHP chemotherapy (R-CHP) or obinutuzumab plus CHP chemotherapy (G-CHP).~     Participants will be treated for a total of six or eight cycles in accordance with local~     institutional practice. Two parallel treatment arms will explore doses of polatuzumab vedotin~     in combination with R-CHP or G-CHP. The maximum tolerated dose (MTD) or recommended Phase 2~     dose (RP2D) of polatuzumab vedotin in combination with R-CHP will be identified before it is~     combined with G-CHP. Once the MTD or RP2D is determined, polatuzumab vedotin will be dosed at~     MTD or RP2D -1 in combination with G-CHP to start the dose escalation of this combination.~   "
120320|NCT01992640|"~     During laparoscopic surgery, muscle relaxants are often administrated in order to ensure~     acceptable surgical conditions. These drugs bind to receptors in the neuromuscular junction.~      The degree of muscle relaxation is monitored by use of an acceleromyography and at the end of~     surgery another drug - Neostigmine- is given to reverse the muscle relaxation. However,there~     may still be a blockade of up to 70% of the receptors.~      This partial muscle relaxation may result in muscle weakness, reduced balance and prolonged~     hospitalization.~      This study will describe changes in balance and subjective muscle weakness after laparoscopic~     surgery.~      The primary hypothesis is that sway area is increased 30 min after extubation compared to the~     preoperative value.~   "
120321|NCT01992627|"~     This study will determine the efficacy of High Intensity Laser Therapy (HILT) for the~     treatment of elbow epicondylosis~   "
120322|NCT01992614|"~     PF-06678552 is a new compound proposed for the treatment of hypercholesteremia. The primary~     purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and~     pharmacodynamics of single oral doses of PF-06678552 in healthy subjects.~   "
120323|NCT01992601|"~     This clinical trial is designed to compare the pharmacokinetic characteristics of combination~     and separate administration of Crestor(Rosuvastatin) and Micardis(Telmisartan). Also~     investigate drug interaction between separate and combination administration.~      Total number of subjects is 48. 4 group(12 for 1 group), 2 period, consecutive 6 day~     administration, 16 days washout after 6th day of administration.~      The subjects of Part 1 take Crestor alone and Crestor+Micardis combination by a cross-over~     design during 2 each period.~      The other subjects of Part 2 take Micardis alone and Crestor+Micardis combination by a~     cross-over design during 2 each period.~   "
120456|NCT01990846|"~     To evaluate the safety, tolerability and pharmacokinetics (PK) of single,and repeat~     escalating doses of FF-3 dry powder administered via inhalation in healthy adult subjects~   "
120325|NCT01992575|"~     Retinal blood vessel disease encompasses a wide variety of vision-threatening conditions. Of~     these conditions, retinal vein occlusions are the most common. Vision loss can occur as a~     result of macular ischemia (loss of blood flow to the macula) or macular edema (fluid~     build-up at the macula).~      OCT is an imaging technology that can perform non-contact cross-sectional imaging of retinal~     and choroidal tissue structures in real time. It is similar to ultrasound imaging, except~     that OCT measures the intensity of reflected light rather than sound waves.~      The purpose of this study is to see if non-invasive OCT technology can changes due to retinal~     vein occlusions as well as the more invasive fluorescein angiography, which requires an~     injection of dye into the vein of an arm of a patient. The study will also compare the~     mapping of blood vessels (angiography) and loss of blood flow (ischemia) by fluorescein~     angiography and OCT. These studies will be evaluated to see how they relate to vision loss.~   "
120326|NCT01992562|"~     This is a phase 4 study being conducted at the Ohio State University Department of Neurology~     Multiple Sclerosis Research Program. The purposes of the study is to administer a single shot~     of intrathecal (injection into the space surrounding the spinal cord via a lumbar puncture or~     spinal tap) ziconotide as a test dose to patients who have chronic painful myelopathy (pain~     from spinal cord damage) or painful peripheral neuropathy (pain from nerve damage) that has~     not responded to other pain medicines. Study Hypothesis: We intend to determine if a single~     shot trial (SST) of intrathecal (IT) ziconotide will temporarily reduce pain in these~     patients. In the proposed study, patients will receive two injections, one of which is the~     ziconotide and one which is a placebo. They will be blinded and not know which order they~     receive the treatment versus placebo. The results of this clinical trial will provide a~     focused examination of ziconotide efficacy and safety in patients with painful neuropathies~     or myelopathies that have not been effectively treated with other pain medications. Moreover,~     the use of a single shot trial (SST) IT injection in the outpatient setting will provide~     evidence for application of this technique in outpatient neurological clinical practice,~     thereby improving access to this specific patient population. Ziconotide is currently FDA~     approved for this indication and route of administration. Therefore, a study design that~     improves the feasibility of ziconotide trialing specifically in the neurology clinic (that~     is, single shot administration) is being used in order to ensure its broader use by~     neurologists who routinely care for neuropathy and myelopathy patients. Information from this~     study will also inform future studies of predictors for long term efficacy after pump~     placement.~   "
120327|NCT01992549|"~     The purpose of the study is to collect long-term data on the inhibitor development rate of~     Human-cl rhFVIII in previously untreated patients with severe Hemophilia A.~   "
120328|NCT01992536|"~     The purpose of this extension study is to evaluate the immunogenicity and safety of a booster~     dose of a MenABCWY vaccine, administered 24 months after completion of the primary~     vaccination series, in subjects who previously received the same vaccine formulation in study~     V102_03 (NCT01272180) (Groups I and II). Antibody persistence at 24 and 36 months after the~     primary vaccination and 12 months after the booster dose will also be evaluated in these~     subjects.~      In addition, safety and immunogenicity of two investigational MenABCWY vaccine formulations~     (either a MenABCWY+ OMV or a MenABCWY+¼ OMV) will be assessed in subjects who previously~     received two doses of MenB vaccine (Group III) or one dose of Menveo vaccine (Group IV).~     These subjects will be followed for safety and immunogenicity for 12 months after vaccination~     in study V102_03E1.~   "
120329|NCT01992523|"~     The aim of the Mashed Or Just Integral pill of TicagrelOr (MOJITO) study is to evaluate the~     superiority of Ticagrelor 180 mg LD mashed pill versus Ticagrelor 180 mg LD integral pill~     both orally administrated in decreasing residual platelet reactivity 1 hour after the~     administration among 70 patients with STEMI (ST segment elevation myocardial infarction)~     undergoing PPCI (primary percutaneous coronary intervention) with bivalirudin monotherapy.~   "
120330|NCT01992510|"~     The study was conducted to investigate how postural changes including sitting, supine, and~     LDP(lateral decubitus position) affect the IOP(intraocular pressure) of SO(silicone~     oil-filled eyes. In addition, this study compared the IOP changes between the SO-filled eyes~     and the fellow eyes in each body position.~   "
120331|NCT01992497|"~     Effect, tolerance and safety of a supplementation with a probiotic on the risk of~     gastrointestinal infections, on growth, and on gut microbiota in healthy newborn term infants~     born by Cesarean section. Exploratory comparison between a probiotic vs. placebo in the~     formula-fed and in the breastfed feeding groups.~   "
120332|NCT01992484|"~     The aims of the study are to:~        -  explore whether platelet reactivity in patients treated wih novel platelet inhibitors is~          associated with clinical outcome~        -  investigate whether a therapeutic window exist for novel platelet inhibitors~        -  investigate the incidence of adverse events under treatment with novel platelet~          inhibitors in the real life clinical scenario~        -  investigate the association between genetic polymorphisms, inflammation, platelet~          reactivity and clinical outcome~        -  investigate synergistic effects between aspirin and novel platelet inhibitors~   "
120333|NCT01992471|"~     The purpose of this study is to find out what kinds of information people would like to~     receive from a new kind of genetic testing, and how they respond to this new kind of testing.~   "
120334|NCT01992458|"~     The indication of implantable cardioverter defibrillator (ICD) therapy for primary prevention~     of sudden cardiac death has been introduced later in France than in other parts of the World.~     Overall, we aimed to assess the risk-benefit ratio of this strategy over a 10 year period.~   "
120335|NCT01992445|"~     Thought Markers (Tm) and Biomarkers(Bm) to accurately predict the likelihood of a repeated~     suicide attempt.~   "
120336|NCT01992432|"~     This study will use advanced MRI techniques to characterize the changes that occur to the~     structure and functionality of the brain in older breast cancer patients receiving adjuvant~     chemotherapy, and determine the relationship between the brain changes and severity of~     chemotherapy toxicity. Our results will be an early step towards identifying neuroimaging~     markers of aging, breast cancer and chemotherapy treatment, and will contribute to our~     understanding of the underlying pathophysiology of cognitive changes and chemotherapy~     toxicity in vulnerable, older adults with cancer. Furthermore, the work will lay the~     foundation for future, larger scale clinical studies of cognitive changes and chemotherapy~     toxicity in the aging cancer population.~   "
120338|NCT01992406|"~     Natural orifice transluminal endoscopic surgery has become an important topic. NOTES access~     routes give the opportunity to reduce surgical access trauma leading to a more painless~     surgery and enhancing a fast postoperative recovery. Experience with transvaginal~     laparoscopic cholecystectomy and transvaginal anterior resection for diverticulitis show that~     such NOTES procedures are feasible and safe. The complication rate to conventional~     laparoscopic procedures is similar. Since transvaginal access is impossible in men, an~     alternative route is missing. There are experimental studies and small case series reporting~     the feasibility of transrectal anterior resection. However any prospective feasibility study~     demonstrating the safety of the procedure and functional outcomes (sphincter function) are~     missing. This study investigates the feasibility, practicability, safety and subjective as~     well as functional outcome of transrectal hybrid-NOTES anterior resection.~   "
120339|NCT01992393|"~     For this project we propose to refine the psychosocial intervention developed in phase one,~     based on input from key stakeholders, and to test the feasibility, acceptability and~     preliminary efficacy of the intervention. The proposed project addresses unmet public health~     needs for a historically hard-to-reach group of individuals with epilepsy and comorbid~     serious mental illnesses, and as the intervention is an adjunct to care that individuals with~     serious mental illness are already receiving, and uses staff already likely to be present in~     a care system, it is ideally suited for real-world implementation in people with epilepsy~     and serious mental illness (E-SMI).~      The purpose of this study is to try and engage individuals with E-SMI to actively participate~     in illness self-management and treatment adherence that are crucial in minimizing the~     morbidity and mortality associated with both chronic mental disorders and chronic~     neurological conditions.~   "
120340|NCT01992380|"~     This study will test if two 18F-AV-1451 PET scans up to 4 weeks apart in healthy volunteers,~     MCI and AD subjects provide the same results.~   "
120341|NCT01992367|"~     This is a single-centre, placebo-controlled, randomised, double-blind study to evaluate the~     safety and tolerability of single ascending doses (SAD) and multiple ascending doses (MAD) of~     ASLAN003 in healthy subjects~   "
120342|NCT01992354|"~     The PET/MR device components and accessories are under development in order to optimize,~     validate and improve the design including improving the quality of images. The purpose of~     this study is:~        -  Aim 1: Perform iterative evaluations of the device (including features and components)~          to optimize device performance and assess feasibility of new features;~        -  Aim 2: Perform activities in support of design validation as needed for regulatory~          submission;~        -  Aim 3: Evaluate device complaints and analyze potential causes.~   "
120343|NCT01992341|"~     The purpose of this study is to evaluate the pharmacokinetics of paclitaxel when given alone~     and in combination with AMG 386 to determine whether AMG 386 alters the pharmacokinetics of~     paclitaxel~   "
120344|NCT01992328|"~     Immunoglobulin G deficiency subtypes in patients with asthma six months once a month~     intravenous immunoglobulin (400mg/kg/4weeks) infection in treatment-related effect on~     reducing the frequency of asthma exacerbations appreciate.~   "
120345|NCT01992315|"~     Soft tissue injury leads to significant deformity in size, shape and body contour. Adipose~     tissue, continues to be the tissue of choice in repairing soft tissue defects due to~     traumatic or other defects. Current autologous fat transfer techniques, however, have a~     number of limitations including significant donor site morbidity, unpredictable resorption,~     and the potential for requiring revision. Thus, an off-the-shelf material that retains the~     mechanical and biological properties of adipose tissue would be ideal for the reconstruction.~      Extracellular matrix (ECM)-based biomaterials have the potential to be a non-immunogenic~     biological scaffold for adipose tissue engineering for repair of soft tissue defects. Our~     collaborators have recently generated a novel tissue-derived material to improve soft tissue~     reconstruction. The final, processed adipose tissue does not contain cellular components, yet~     retains the native architecture and bioactivity of the original adipose tissue. The tissue is~     then further processed into particles to create an injectable implant. In preclinical models,~     we have demonstrated that human adipose tissue can be decellularized by mechanical processing~     with preservation of matrix ultrastructure. Histologic analysis two-weeks after implantation~     into rats showed minimal inflammatory reaction and good tissue integration of the~     decellularized, dilipidized, adipose derived-ECM.~      The goal of the study is to 1) evaluate the safety and compatibility of the soft tissue~     implant, and 2) determine the efficacy of this ECM replacement in soft tissue injuries after~     6 weeks. Specifically, the volume of the soft tissue defect will be determined before~     implantation and at multiple time points over the following 6 weeks. We hypothesize that the~     decellularized adipose ECM will retain at least 50% volume and surface area after 6 weeks. If~     our results are promising, decellularized adipose derived-ECM may be a viable alternative to~     autologous tissue transplantation for correction of soft tissue deformity.~   "
120346|NCT01992302|"~     In this study we tried to elucidate the factors associated with the development of a rapid~     cycling course in bipolar disorder patients, in a prospective and longitudinal design, and~     the role of antidepressants. The identification of risk factors is extremely relevant from~     the clinical point of view. We hypothesized that rapid cycling bipolar disorder is associated~     with more chronicity, poor outcome, and more antidepressant prescription.~   "
120347|NCT01992289|"~     The goal of the ECP-002e extension study is to continue the evaluation of all EDI200-treated~     ECP-002 subjects up to age 10 yrs. No additional study drug administration is planned. The~     efficacy evaluations will incorporate growth and development parameters, frequency of~     infections and hospitalizations, and age-appropriate assessments of ectoderm-derived organ~     function. The safety evaluations will include physical examinations, adverse events and~     concomitant medication documentation, and laboratory testing. Funding Source - FDA OOPD~   "
120348|NCT01992276|"~     The purpose of this study is to evaluate the rate of decline in quantitative viral load~     measured in hospitalized patients with Influenza A infection~   "
120349|NCT01992263|"~     The goal of this study is to understand the effects of vitamin D supplementation on~     immunological outcomes among patients with tuberculosis.~   "
120350|NCT01992250|"~     This study examines the use of cryoablation as an alternative to surgery in the treatment of~     early stage invasive breast cancer. The hypothesis is that cryoablation will complete~     ablation and destroy the tumor in a selected population of women who may otherwise be~     adequately treated with surgery.~   "
120409|NCT01991457|"~     The goal of this research is to test if the conditioning regimen, fludarabine and total body~     irradiation (FluTBI), can lead to a safer and more effective stem cell transplant treatment~     regimen for ALL patients older than 40 years of age and/or younger patients with high risk~     medical conditions. The primary objective is to establish the efficacy of allo HCT in older~     ALL patients using myeloablative FluTBI conditioning regimen. The investigators are also~     assessing the safety and toxicity of allo HCT in older ALL patients using myeloablative~     FluTBI conditioning regimen.~   "
120351|NCT01992237|"~     With the perception that lung protective ventilation with regard to low tidal volume~     ventilation and limiting airway pressures improves outcome in ARDS (acute respiratory~     distress syndrome) and that the development of new technical devices of extracorporeal lung~     assist systems with lower complication rates support establishment of lung protective~     ventilation strategies these systems are more and more frequently used. All critically ill~     patients with and without ECLA (extracorporeal lung assist)/ECMO (extracorporeal membrane~     oxygenation) treatment are on high risk for muscle wasting, leading to more comorbidity and~     higher mortality risk. Besides inflammation malnutrition is known as one of the main risk~     factors. Over and underfeeding should be prevented. However nutritional aspects of patients~     on extracorporeal lung assist are hardly investigated. Up to now changes in metabolic rates~     induced by ECLA/ECMO are poorly described. Factors like work of breathing, changes in cardiac~     output and septic state are influencing energy metabolism but until now there is no tool for~     measuring energy expenditure in clinical routine for patients on ECLA/ECMO. Indirect~     calorimetry is a simple device only for patients without ECLA/ECMO system. Oxygenation and~     CO2 (carbon dioxide) elimination by the lung assist system can be calculated but is not~     implemented to clinical routine. The combination of indirect calorimetry and calculation of~     lung assist function at the same time would give us the chance to adapt nutrition rates to~     energy expenditure. This may prevent muscle wasting and weakness. This pilot study will~     include 40 participating patients during 8 month investigating nutritional therapy adapted to~     energy expenditure calculated by O2 and CO2 turnover rates in patients on ECLA or ECMO~     systems. The investigators aim is to describe a calculation to set nutrition targets in ECMO~     patients. Second the investigators will describe level of nutritional needs under~     consideration of different mechanical ventilation states. Third O2 consumption and CO2~     elimination will be used to estimate cardiac output.~   "
120352|NCT01992224|"~     Acute lung injury (ALI) and acute respiratory distress syndrome(ARDS) represent the most~     common and earliest organ dysfunction in acute pancreatitis, presenting as dyspnea and~     intractable hypoxemia, with secondary bilateral pulmonary infiltrates on radiograph. And~     mechanical ventilation (MV) is the essential intervention to improve oxygenation. When to~     initiate MV remains uncertain. In this study, we aim to compare the effect of early MV and~     conventional MV, and we hypothesize that early MV may be a better treatment option.~   "
120353|NCT01992211|"~     The purpose of this study is to evaluate the pharmacokinetic Profile and Safety/Tolerability~     of BCWP_C003 compared to Co-Administration of Crestor 10mg and Glucophage XR 1000mg, and to~     evaluate the food effect of Pharmacokinetic profile of BCWP_C003 after administration.~   "
120354|NCT01992198|"~     Strategy of antibiotic therapy in SAP,De-escalate (cefoperazone+metronidazole) or Escalate~     (meropenem) therapy,which one is better.~   "
120355|NCT01992185|"~     Photocil is a topical drug (cream) that selectively delivers Narrow Band - Ultraviolet B~     (NB-UVB) therapy when exposed to sunlight. Photocil is intended to help protect users from~     non-therapeutic Ultraviolet B (UVB) radiation while selectively passing wavelengths of light~     in the NB-UVB range with peak transmission of 308nm. The aim of the study is to assess the~     safety and efficacy of Photocil in the treatment of vitiligo.~   "
120356|NCT01992172|"~     Photocil is a topical drug (cream) that selectively delivers Narrow Band - Ultraviolet B~     (NB-UVB) therapy when exposed to sunlight. Photocil is intended to help protect users from~     non-therapeutic Ultraviolet B (UVB) radiation while selectively passing wavelengths of light~     in the NB-UVB range with peak transmission of 308nm. The aim of the study is to assess the~     safety and efficacy of Photocil in the treatment of atopic dermatitis.~   "
120357|NCT01992159|"~     The purpose of this study is to determine if treatment with romosozumab increases bone~     mineral density in Japanese women with postmenopausal osteoporosis.~   "
120358|NCT01992146|"~     Recent studies have focused on the role of endogenous opioids on central sensitization.~     Central sensitization is known to be impaired or altered in chronic pain conditions, as~     fibromyalgia or chronic tension headache.~      Animal studies have shown reinstatement of mechanical hypersensitivity following naloxone~     administration after resolution of an injury. This suggests latent sensitization.~      In the present study, investigators hypothesize that a high-dose target-controlled naloxone~     infusion (total dose: 3.25 mg/kg) can reinstate pain and hyperalgesia 6-8 weeks after a~     unilateral primary open groin hernia repair procedure. Investigators aim to show that latent~     sensitization is present in humans and is modulated by endogenous opioids.~   "
120359|NCT01992133|"~     Gestational Diabetes Mellitus (GDM) and vitamin D deficiency are related to insulin~     resistance and impaired beta-cell function, with heightened risk for future development of~     diabetes. The investigators hypothesize that vitamin D supplementation to women with previous~     gestational diabetes may improve glucose metabolism.~   "
120360|NCT01992120|"~     The primary objective of the proposed study will be to determine if a multi-modality teaching~     curriculum utilizing high-fidelity simulation and didactic lecture will result in sustained~     improvement by internal medicine residents in written knowledge and clinical performance when~     compared to residents receiving a curriculum utilizing only didactic lecture. The~     investigators hypothesis is that the addition of high-fidelity simulation to a traditional~     didactic lecture curriculum will result in sustained and superior written knowledge and~     practical performance when compared to a group receiving only didactic lecture on the same~     topic. Specifically, the investigators will be assessing internal medicine resident knowledge~     and performance in the area of sepsis in the hospitalized patient, and will shape the~     investigators teaching curriculum around this focus.~   "
120361|NCT01992107|"~     Evaluate safety and immunogenicity of three influenza vaccines in children ages greater than~     4 years old to less than 18 years old.~   "
120362|NCT01992094|"~     Evaluate safety and immunogenicity of three influenza vaccines in adults 18 years of age and~     above.~   "
120363|NCT01992081|"~     This study will test two instruments to measure physical activity in COPD patients: A~     questionnaire and two small physical activity monitors .Patients will be randomized to either~     receive the telecoaching program in addition to usual care or only the usual care. Study will~     include around 510 patients in 5 countries in Europe.~   "
120364|NCT01992068|"~     The purpose of this study is to prospectively assess the feasibility of high-resolution~     manometry to identify radiation-induced changes in esophageal motility and contractility or~     function in patients undergoing radiation therapy for the treatment of locally advanced~     lung cancer.~   "
120410|NCT01991444|"~     Registry study to evaluate the predictive value of a comprehensive geriatric assessment with~     regard to the outcome of a transcatheter aortic valve Implantation.~      It will be evaluated which parts of the comprehensive geriatric assessment (CGA) are best~     suited to predict the therapeutic success of a heart valve Implantation in elderly ( > 80~     years) Patient. Possible participants are all Patient of 80 years or above for whom the~     implantation of a Edwards Sapien XT aortic valve is planned~   "
120411|NCT01991431|"~     This is an international multi-center, prospective, observational registry with consecutive~     patient enrollment intended to determine outcome Parameters within 30 days after transaortic~     transcatheter aortic valve replacement.~   "
120365|NCT01992055|"~     This Clinical Trial is a pilot study being conducted to study the impact of a specific~     cognitive rehabilitation program, Goal Management Training (GMT), in adult patients with~     executive dysfunction and associated problems in everyday functioning. The intervention~     program will also include relaxation training and psychoeducation regarding brain injury on~     everyday functioning, emotional status, and executive functioning. Goal Management Training~     focuses on teaching individuals strategies to compensate for executive functioning deficits~     and is based on a theory of goal neglect resulting in disorganized behavior following frontal~     lobe injury. It emphasizes strategies for self-monitoring and self-evaluation in everyday~     life. Given its goal-oriented emphasis, focus on individual everyday difficulties, and~     reports of improvements in self-reported executive failures and mood, GMT appears to be an~     ideal intervention treatment for individuals with executive and functional deficits.~      Given the emphasis of goal-oriented rehabilitation on reducing the impact of cognitive~     impairment on daily functioning, rather than attempting to restore cognitive abilities, a~     reduction in subjective reports of psychological distress is anticipated. This hypothesis is~     consistent with existing literature revealing reduced reports of annoyance and executive~     difficulties on self-report inventories. Improvements on tests of sustained attention and~     visuospatial problem-solving, as well as small effects on additional measures of planning,~     are also anticipated.~   "
120366|NCT01992042|"~     This research study provides a novel opportunity to examine the intra-prostatic tumour~     inhibitory effects of statins in men with prostate cancer undergoing surgery.~   "
120367|NCT01992029|"~     The principal goal is to demonstrate that a specific pattern of microRNA (miRNA) expression~     can be correlated with the definite diagnostic of Amyotrophic Lateral Sclerosis (ALS). The~     investigators will use biological sample (from muscle biopsy, Cerebrospinal Fluid (CSF) and~     blood sample) collected in three control populations: definite ALS patients according to El~     Escorial diagnostic criterion, control patients without any neurological disease having an~     orthopedic surgery for shoulder disease, and control patient explored for peripheral~     neuropathy and myopathy. A second goal will correlate the miRNA pattern to the severity~     and/or progression rate of the motor neurons define as the progression rate of the~     Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) score/year.~   "
120368|NCT01992016|"~     This pilot clinical trial studies fludeoxyglucose F18 (FDG)-positron emission tomography~     (PET) in imaging patients with prostate cancer treated with ranolazine. Diagnostic~     procedures, such as FDG-PET, may help find prostate cancer and find out how far the disease~     has spread. Giving ranolazine may enhance FDG-PET imaging by increasing the amount of glucose~     available for uptake by the scan.~   "
120369|NCT01992003|"~     The primary purpose of this study is to assess the accuracy of the newly released Masimo SpHb~     Butterfly Sensor with RevK version and compare the results to a blood hemoglobin level~     analyzed in the UCSF Clinical Laboratories. A secondary purpose is to assess the blood~     hemoglobin using the Masimo Pronto-7 hand-held device immediately prior to surgery.~   "
120370|NCT01991990|"~     This Phase IV, single-blind , randomized, two-arm study will explore the pharmacodynamics~     effects of RoActemra/Actemra (tocilizumab) on neutrophil redistribution, function and~     survival in healthy subjects. Subjects will receive either a single dose of intravenous (IV)~     RoActemra/Actemra at a dose of 8 mg/kg over one hour on study Day 0 or placebo. Neutrophil~     kinetics data will be collected for all subjects up to Day 10 of the study. Following the~     last study visit on Day 10, all subjects will attend two further safety follow-up visits on~     Day 28 and Day 56.~   "
120371|NCT01991977|"~     This phase II trial studies how well fluorine F 18 fluorodopa (18F-DOPA)-positron emission~     tomography (PET) works in finding tumors in patients with newly diagnosed gliomas undergoing~     radiation therapy. Comparing results of diagnostic procedures done before and during~     radiation therapy may help doctors predict a patient's response to treatment and help plan~     the best treatment.~   "
120372|NCT01991964|"~     The hypothesis of the study is that laryngeal US can accurately and reliably diagnose~     laryngomalacia in infants with congenital stridor.~      Stridor is a respiratory noise caused by partial obstruction of the large airways at the~     level of the pharynx, larynx and/or trachea. The most prevalent congenital cause of stridor~     is laryngomalacia. Flexible laryngobronchoscopy (FLB) under sedation is regarded as the gold~     standard. However, FLB under sedation has some drawbacks as it requires venous access, use of~     sedative agents, may cause discomfort for the patient and is costly.~      Ultrasound (US) is a noninvasive, painless, radiation free, well tolerated imaging technique.~     It allows for dynamic assessment of moving structures in an awake patient and the results can~     be easily displayed and recorded.~   "
120373|NCT01991951|"~     We hypothesized that in patients with low CHADS-VASc score (2 or < 2), there is no difference~     in thromboembolic or bleeding events between patients with short term warfarin therapy (2~     weeks after catheter ablation) and conventional therapy (3 weeks before and 8 weeks after~     procedure).~   "
120374|NCT01991938|"~     This is a Phase I, open-label, multicenter, dose-escalation trial of VS-5584, a PI3K/mTOR~     kinase inhibitor, in subjects with advanced non-hematologic malignancies or lymphoma. This~     clinical study is comprised of 2 sequential parts: Part 1 (Dose Escalation) and Part 2~     (Expansion). The purpose of this study is to evaluate the safety (including the recommended~     Phase II dose), pharmacokinetics (the amount of VS-5584 in subject's blood) and the~     anti-cancer activity of VS-5584. Biomarkers (genes or proteins that may predict or show how~     subject's body may respond to VS-5584) will also be assessed in archival tumor tissue, tumor~     biopsies (in consenting subjects), and blood samples.~   "
120375|NCT01991925|"~     Patients with hereditary haemochromatosis will be interviewed/questioned about their Quality~     of life and the delivered quality of care in the hospital.~   "
120376|NCT01991912|"~     The classic laminectomy for surgical treatment of spinal stenosis has considerable morbidity~     .This is further magnified by the disease being more common in elderly with associated~     medical comorbidities and being usually global involving multiple levels.The purpose of this~     study is to present and to evaluate a new endoscopic technique named Irrigation Endoscopic~     Decompressive Laminotomy (IEDL) for lumbar spinal canal decompression.~   "
120412|NCT01991418|"~     In pre-clinical study, we found that serum thioredoxin reductase activity harbours huge~     difference after any kind of treatments, so we hypothesis that serum activity of thioredoxin~     reductase may be a warning markers in excised non-small lung cancers, serum activity of this~     enzyme may elevated before CT scan~   "
120377|NCT01991899|"~     It is a clinicaltrial Phase III , randomized, double -blind , 4-arm (390 each one):~      This study will include 1560 children and will use 3 batches of vaccine produced by Bio -~     Manguinhos with viral bulk of GSK combined measles , mumps and rubella applied in healthy~     children 12-15 months of age, and 01 batch of MMR to reference( GSK ), applied in healthy~     children aged 12-15 months old . The vaccine is administered as MMR 1st dose.~      Two hypotheses are tested :~        1. Consistency of production ( equivalence between batches )of 3 batches of vacines(TV1,~          TV2 , TV3 Bio- Manguinhos). Noninferiority vaccine Bio TV (Fiocruz, Rio de Janeiro), ie,~          the measles, mumps and rubella in Brazil is as immunogenic and safe as the measles,~          mumps and rubella reference, already used in routine NIP (production~          Bio-Manguinhos/FIOCRUZ with viral concentrate, bulk, GSK).~           The MMR vaccine (Bio-TV) will have the same composition (vaccine strains) and the same~          method of production of MMR (TV-GSK): Wistar RA27 / 3 rubella, Schwarz strain of measles~          vaccine, and strain RIT 4385 - derived from the Jeryl Lynn strain of mumps vaccine.~           As 2nd dose, children receive the vaccine tetraviral measles-mumps-rubella-varicella,~          aged 15-18 months, according to the guidance of the National Immunization Program.~        2. Noninferiority vaccine Bio TV (Fiocruz, Rio de Janeiro):the measles, mumps and rubella~          vaccine in Brazil is as immunogenic and safe as the measles, mumps and rubella~          reference, already used in routine NIP (production Bio-Manguinhos/FIOCRUZ with viral~          concentrate, bulk, GSK).~      Returns for blood sampling will be scheduled for 51 days, ranging from 42 to 60 days after~     dose of MMR vaccine dose and after tetraviral. We will colect the firt blood sample before~     the first vaccination too.~      It will describe the major adverse events observed after vaccination , comparing their~     frequency in groups of MMR vaccine with the Brazilian reference vaccine .~   "
120378|NCT01991886|"~     Recent large studies have shown that not all premature babies need to be intubated (have a~     breathing tube inserted) and ventilated, nor do they all need to be given lung surfactant~     routinely. Those studies showed that even very small babies can be safely supported using~     nasal Continuous Positive Airway Pressure (nCPAP) which is applied tightly to the nose using~     nasal prongs. This is a type of noninvasive ventilation (NIV) so that the babies continue to~     breath, albeit with additional support to reduce their work of breathing. However nCPAP has~     some drawbacks, including that it can cause skin damage to the nose, and that the heating and~     humidification of the gas is not always sufficient. We have been using, for over 5 years, a~     different system to support babies after routine intubation. This is another type of~     noninvasive ventilation called nasal High Flow (nHF) for which we use a Vapotherm Precision~     Flow device. Published trials show that it is at least as effective as nCPAP to provide NIV~     and to prevent the subsequent need for intubation and/or surfactant. However nHF is superior~     to nCPAP in respect it does not cause nose damage and its heating and humidification is~     excellent. This pilot study aims to describe and evaluate the use of nHF, using a standard~     commercially available system (Precision Flow, Vapotherm Inc.), from birth, in babies born~     less than 30 completed weeks gestation, with a view to avoiding intubation and ventilation.~     This study is important to establish the feasibility of using nHF immediately after birth.~   "
120379|NCT01991873|"~     This is a phase II, randomized, multi-center, open-label, parallel-group study to evaluate~     the progression-free survival during maintenance therapy.~      Eligible patients will be treated within a 12-week induction therapy. Those patients~     achieving CR/PR or SD at 12 weeks and qualifying for maintenance treatment and re-induction~     treatment with all potential drug components, will be randomized in a ratio of 1:1 to receive~     chemotherapy plus panitumumab or chemotherapy alone during maintenance. In case of~     progression, re-induction treatment will be started.~   "
120380|NCT01991860|"~     A comparison of the efficacy of APD421 and placebo in the prevention of PONV in patients at~     moderate-to-high risk of PONV.~   "
120381|NCT01991847|"~     The purpose of this study is to determine the feasibility of a one year exercise training~     program in post-surgical patients with colorectal cancer.~   "
120382|NCT01991834|"~     Laparoscopy is a surgical procedure indicated for most gynecological pathologies and presents~     numerous advantages over laparotomy, among them lower rates of surgical site infection and~     less comorbidity feverish. Despite this, the use of antibiotic prophylaxis is widely accepted~     and performed by most gynecologists. However, there isn't literature evidence to support the~     routine use of antibiotics in the prophylaxis of wound infection on laparoscopic pelvic~     surgery .Therefore, this study will evaluate the need for the use of antibiotic prophylaxis~     in gynecological laparoscopies not including opening hollow viscera.~   "
120383|NCT01991821|"~     A comparison of the efficacy of APD421 and placebo in the prevention of PONV in patients at~     moderate-to-high risk of PONV.~   "
120384|NCT01991808|"~     This is a pilot study of DCE MR imaging to detect vascular changes in the vagina during and~     after radiotherapy n patients receiving adjuvant brachytherapyfor cervical or endometrial~     cancer.~   "
120385|NCT01991795|"~     The purpose of this study is to compare the effect of ticagrelor versus placebo in patients~     with Type 2 Diabetes Mellitus.~   "
120386|NCT01991782|"~     The purpose of this study is to determine whether telemedicine video calls for follow-up~     visits between patients and their orthopaedic trauma surgeons has an impact on patient~     satisfaction, quality of life, and treatment adherence. This study will also assess the~     feasibility of telemedicine as a medium for follow-up visits.~   "
120387|NCT01991769|"~     The purpose of this study is to examine whether exercise reduces the postprandial effects of~     an unhealthy meal on heart function and endothelial function.~      Both healthy people and type 2 diabetes subjects will during three days either carry out two~     different sessions of exercise training or not before ingesting an unhealthy meal high in~     saturated fat and fast carbohydrates. The two different exercise training modes used are high~     intensity interval training (HIIT) and moderate intensity training (MIT) Hypothesis: Exercise~     training in advance of an unhealthy meal will improve endothelial- and cardiac function in~     healthy and type 2 diabetes individuals. HIIT will reduce the negative postprandial effects~     on the endothelium more than MIT.~   "
120388|NCT01991756|"~     The primary objective of the study is to evaluate the acute safety of deploying and~     implanting the Altura Endograft in the treatment of AAA in subjects who are candidates for~     endovascular repair.~      Secondary objectives are to evaluate the acute and longer-term safety and performance of the~     Altura Endograft through 5 years.~   "
120389|NCT01991743|"~     We plan to conduct a prospective, single blinded, randomized clinical trial to assess the~     impact of combined spinal-epidural dosing on the success rate of, and patient satisfaction~     during, external version for breech fetal position and the incidence of vaginal vs. Cesarean~     delivery.~      The research aim of this project is to determine the ideal neuraxial dosing strategy to~     maximize success of external cephalic version (ECV).~      The research questions, does a combined spinal-epidural (CSE) of a higher dose result in~     greater success in converting a breech presentation to vertex during external cephalic~     version (ECV).~      The hypotheses of this project is that CSE at higher dose will result in greater ECV success~     than analgesic dosing.~      The research significance:Increasing the success and comfort of ECV for fetal malpresentation~     may help decrease the cesarean section rate.~   "
120390|NCT01991717|"~     Cataract surgery is among the world's most frequently performed operations. It involves~     removal of an opaque lens from the human eye and implantation of an artificial lens. The~     operation is performed under local anaesthesia using ultrasound technology, by which the lens~     is emulsified and removed by suction.~      Femtosecond laser-assisted cataract surgery is a new innovative surgical procedure that can~     improve the quality of cataract surgery and provide a new best possible standard of quality.~     In contrast to the conventional method the capsulotomy and the fragemntation are fully~     automatically performed with a femtosecond laser. In addition, the lens is fragmented by the~     laser, which substantially facilitates its removal and reduces the operation time.~      Study to investigate whether the femtosecond laser cataract surgery causes any significant~     differences in clinical outcomes as compared to the conventional, manual continuous~     curvilinear capsulorhexis (CCC).~      Effective phako time (EPT) is defined as duration of phakoemulsifikation of the crystalline~     lens.~      EPT of conventional surgery at intraoperative visit > EPT oflaser-assisted surgery at~     intraoperative visit~   "
120391|NCT01991704|"~     In order to determine whether the 'incubation of craving' phenomenon also occurred in~     alcoholics, investigators employed an experimental approach to investigate the time course of~     cue-induced craving in alcoholism. Eighty male participants were randomly divided into Four~     groups, and they were assessed at 7, 14, 30, and 60 days of abstinence for cue-induced~     alcohol craving . Another group including 19 patients was repeatedly tested for the~     cue-induced alcohol craving at the above abstinence days. Other psychological and~     physiological measures were administered at the four abstinence time points.~   "
120392|NCT01991691|"~     This study is a single arm feasibility study. Patients that have been diagnosed with~     carcinoma and are undergoing chemotherapy have to document chemotherapy associated side~     effects on a regular basis by means of a tablet-based online questionnaire. Goal of the study~     is to find out if patients that are undergoing chemotherapy are willing to document~     chemotherapy associated side effects by means of a tablet-based online questionnaire.~   "
120393|NCT01991678|"~     The purpose of this study is to investigate the PK and safety of NKTR-102 in patients with~     mild, moderate, or severe hepatic impairment.~   "
120394|NCT01991665|"~     A failed operative vaginal delivery is associated with increased risk of maternal and~     perinatal complications. It is very important the determination of the fetal head position~     prior to instrumental delivery.~      Generally,diagnosis of the fetal head position is made on transvaginal digital examination by~     delineating the suture lines of the fetal skull and the fontanelles. There is a paucity of~     studies on the accuracy of digital examination but the general consensus is that~     reproducibility is low and diagnostic uncertainty remains high even for operators with much~     experience.~      As the traditional clinical evaluation has many limitations, a new tool capable of increasing~     diagnostic objectivity and accuracy would be of great interest.~      The aim of our study was to evaluate, in a prospective study, if the complementary use of~     ultrasound scan, to diagnose the fetal head position prior to instrumental delivery, may play~     a role in labor outcome.~   "
120395|NCT01991652|"~     Significant progress has been made in the treatment of Wilms tumor in high income countries,~     where survival is now around 85% - 90%. Survival in low income countries is much lower;~     specific challenges include late presentation, malnutrition, less intense supportive care~     facilities and failure to complete treatment.~      A comprehensive treatment guideline was introduced in Malawi in 2006 which included~     nutritional support and social support to enable parents to complete treatment. Survival has~     increased to around 50%; 95% of children completed their treatment. A multi-disciplinary~     group of African clinicians and 'state of the art' experts produced a consensus treatment~     guideline for children with Wilms tumor in sub-Saharan Africa. This guideline will be~     implemented as a multi-center prospective clinical trial in 2014 in six - eight institutes,~     expecting about 200 new patients per year.~      The hypothesis is that 2 year event free survival will be 50%, with <10% failure to complete~     treatment and <10% treatment related mortality. Other research questions include efficacy and~     toxicity of preoperative chemotherapy and the comparison of surgical staging, local pathology~     and central review pathology in stratifying postoperative chemotherapy.~   "
120396|NCT01991639|"~     Background: In elderly subjects frailty and malnutrition are very common and can lead to~     serious health hazards, increase mortality, morbidity, dependency, institutionalization and a~     reduced quality of life. In Austria, the prevalence of frailty and malnutrition are~     increasing steadily and are becoming a challenge for our social system. Physical training and~     adequate nutrition can invert it.~      Methods/Design: In this randomized, controlled trial 80 malnourished, frail,~     community-dwelling patients (≥ 65 years) are recruited. Additionally, 80 lay volunteers (≥ 50~     years) named buddies are recruited and subsequently trained regarding health enhancing~     physical activity and nutrition in three standardized training sessions. These buddies visit~     the malnourished, frail subjects at home twice a week for about one hour during an initial~     period of 10-12 weeks. While participants allocated to the intervention group (n=40) conduct~     intervention to improve their fluid intake, their protein and energy intake, perform strength~     training and try to increase their baseline activities, the control group (n=40) only gets~     home visits without any special intervention. After 10-12 weeks, both, the intervention and~     the control group, receive the nutrition intervention and the physical training. Health,~     nutrition and frailty status, physical fitness and body composition and chronic inflammation~     of buddies and frails are recorded before the intervention, after 10-12 weeks, and after 6~     and 12 months.~      Discussion: To the investigators knowledge this trial is the first of its kind to provide~     nutrition and physical activity intervention to malnourished, frail, community-dwelling~     subjects by trained lay buddies, in which the health status of buddies is also expected to~     improve. This study assesses the effectiveness of such an intervention. If successful, the~     intervention offers new perspectives for the management of frailty and malnutrition.~   "
120397|NCT01991626|"~     Previous studies on iron absorption have focused on the effects on the addition of iron~     absorption enhancers like ascorbic acid and EDTA to a meal and more recently the enzymatic~     phytic acid removal through phytase. The investigators want here to investigate the effects~     of fat on iron absorption with and without the addition of exogenous phytase as a potential~     iron absorption enhancer in lipid nutrient supplements (LNS) products compared to~     micronutrient powder(MNP) products.~      Furthermore the investigators will evaluate the effects of Lipids- on iron absorption to~     induce the ileal brake by ingestion of a fat emulsion prior to a meal. Increasing the caloric~     density of a meal by increasing its fat content might enhance iron absorption by delaying~     gastric emptying, gastric acid secretion and increasing Fe stomach residence time.~   "
120398|NCT01991613|"~     We hypothesize that premature infants who receive their mothers' expressed breast milk~     supplemented with liquid protein early in their hospitalization will have a growth velocity~     in the first 28 days of life that is 20% greater than the growth velocity of premature~     infants that do not receive protein fortification.~   "
120469|NCT01990677|"~     To test the effect oral eplerenone versus placebo in patients with central serious~     chorioretinopathy .~   "
120399|NCT01991600|"~     Iron deficiency is the most common micronutrient deficiency in the world today, affecting~     more than 60% of the global population (www.who.int/nut/ida.htm). The two main strategies for~     the prevention and treatment of iron deficiency involve fortification of food with iron, or~     direct supplementation with iron tablets. Simple iron salts (e.g. ferrous sulphate) are well~     absorbed but at supplemental levels (and potentially at lower levels, as used in food~     fortificants) can induce free radical activity resulting in gastrointestinal side effects and~     systematic oxidative stress. As a result, supplementation has poor compliance and improvement~     in iron status is compromised. Ferric salts are less inclined to produce side effects and~     although they are relatively well absorbed at fortification levels in food, they are poorly~     absorbed at the higher supplemental doses. Because certain components of food, such as~     organic acids, can facilitate ferric iron absorption, we now wish to determine whether~     dietary organic acids may similarly enable efficient absorption of supplemental ferric iron~     while preventing the formation of non-transferrin-bound iron (NTBI) which is a proxy for free~     radical activity. Our strategy is to use an iterative process between in vitro and in vivo~     experimentation, aimed at identifying the best choice of organic acid and the optimal ratio~     of iron:organic acid. The study was a cross-over, single-dose comparison against~     standard-of-care therapy (namely ferrous sulphate) in mildly iron deficient anaemic women.~     Both the investigational products and the active comparator were administered as a single~     dose on 2 different occasions, i.e. the investigational products on the first study visit and~     the active comparator 14 days later on the second study visit.~   "
120400|NCT01991587|"~     A phase I/II trial conducted in a single centre, observer-blind, randomized, dose-ranging,~     placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of a single~     intramuscular injection of plant-based Seasonal Quadrivalent VLP Influenza Vaccine~     administered to healthy adults 18-49 years of age.~      A total of one hundred and twenty (120) subjects will be randomized in four (4) groups of 30~     subjects to receive one injection of either a low, a medium, or a high dose level of VLP of~     the quadrivalent VLP influenza vaccine or the placebo preparation (100 millimolar (mM)~     phosphate buffer + 150 mM sodium chloride (NaCl) + 0.01% Tween 80).~   "
120401|NCT01991574|"~     Ferric hydroxide adipate is a ferric iron supplement containing iron hydroxide and a dietary~     organic acid that was developed at MRC Human Nutrition Research. We aim to determine if the~     ingestion of ferric hydroxide adipate with food induces a reduction in urinary phosphate~     concentration, compared with the administration of placebo plus the same food on a different~     occasion. We hypothesise that ferric hydroxide adipate binds some phosphate ions in the~     gastrointestinal tract, which prevents part of the phosphate load in a meal from being~     absorbed. On another visit, calcium will be given with the same food, as a positive control,~     since this element is well known to restrict dietary phosphate absorption through the~     formation of insoluble calcium phosphates in the gut lumen. We will compare urinary phosphate~     concentrations after co-ingestion of the calcium salt and food versus urinary phosphate~     following ferric hydroxide adipate and the same food. Additionally, the calcium data will be~     compared with placebo data, since a significant reduction in urinary phosphate concentrations~     after calcium treatment will confirm the suitability of the study design.~      Finally, iron absorption from the ferric hydroxide adipate treatment will be determined by~     labelling this preparation with 58Fe and measuring day 14 erythrocyte 57Fe:58Fe.~      The study design is: Three-way cross-over volunteer absorption study. Volunteers will not be~     told which treatment they receive (placebo, ferric hydroxide adipate, or supplemental~     calcium). Researchers co-ordinating the study on a day to day basis will be aware of~     treatment allocation, but analysts will not be told which samples correspond to which~     treatments.~   "
120402|NCT01991561|"~     A phase 2, Randomized, Observer-blind, Multicenter, Dose-Ranging Study to Evaluate the~     Immunogenicity, Safety, and Tolerability of the plant-made H5 VLP Influenza vaccine~     adjuvanted with Alhydrogel or Glucopyranosyl-lipid adjuvant in squalene emulsion (GLA-SE), in~     healthy adults 18-60 years of age.~   "
120403|NCT01991548|"~     This four center international study will include two United Kingdom National Health Service~     centers, and two centers in Melbourne, Australia. The objective of the study is to evaluate~     subject acceptance of a new insulin pump and transmitter together with the accompanying~     training materials. Descriptive data from participant questionnaires and device uploads will~     be evaluated.~      Pediatric subjects between the ages of 7 - 18 years and adults from the age of 19 years of~     age upwards, who currently use an insulin pump in the management of their type 1 or type 2~     diabetes, will be invited to participate. Each subject will be trained on the study device~     and then use it for approximately four weeks. During this time there will be three in-clinic~     visits and four follow-up phone calls, scheduled at the subjects' convenience. At the end of~     this period, they will revert back to their original insulin pump and complete a~     questionnaire on the study pump training materials, features and usability.~   "
120404|NCT01991535|"~     The purpose of this study is to determine whether breathing pattern (specifically the~     inspiratory time/total respiratory cycle value) has an influence over the response to the~     noninvasive mechanical ventilation.~   "
120405|NCT01991522|"~     Colonoscopy is a commonly used medical procedure. Medical and surgical residents learning~     colonoscopy typically learn the procedure experientially but simulation based teaching is~     increasingly being integrated into training programs. The optimal manner to teach colonoscopy~     on virtual-reality simulators is uncertain. We aim to test a curriculum in simulation-based~     colonoscopy with self-directed learning on simulators.~   "
120406|NCT01991509|"~     The purpose of this study is to assess the safety, tolerability and blood levels of LBR-101~     when administered intravenously or subcutaneously to healthy volunteers.~   "
120407|NCT01991483|"~     This study will evaluate the safety of LY2928057 and how LY2928057 affects hemoglobin in~     hemodialysis participants. This study will involve multiple doses of LY2928057 given during a~     6 week period either after a participant discontinues or reduces treatment to stimulate red~     blood cells. This study will last up to 26 weeks for each participant.~   "
120408|NCT01991470|"~     The purpose of this study is to evaluate the Enlite Sensor™ and Enlite 3 Sensor performance~     in pediatric patients with insulin requiring diabetes at the beginning, middle and end of~     sensor wear.~   "
120519|NCT01990027|"~     The SKSC is a continuous database with the objective of a standardized diagnosis and~     monitoring of patients with kidney stones as well as the establishment of a Biobank.~   "
120413|NCT01991405|"~     Background:~      Mild Cognitive Impairment (MCI) is a condition characterized by memory problems more severe~     than normal cognitive changes due to old age, and less severe than dementia. Reduced working~     memory (WM) is regarded as one of the core symptoms of an MCI-condition. Recent studies have~     indicated that WM can be improved trough computer based training.~      Objectives:~      The objective of the study is to evaluate if working memory training is effective in~     improving working memory in elderly MCI-patients. Further, to evaluate if cognitive training~     relates to structural changes in the white and gray matter of the brain, assessed by~     structural Magnetic Resonance Imaging. Cognitive phenotypes related to memory impairment and~     progression to dementia will also be investigated.~      Patients and Methods:~      The proposed study is a blinded, randomized and controlled trail that will include 90 elderly~     patients from a Memory Clinic diagnosed with MCI. The groups will be randomized to either~     training or a placebo version. The intervention is computerized working memory training~     performed for 45 minutes over 25 sessions. Neuropsychological assessment and structural MRI~     will be performed before, 6 and 12 months after training.~      Relevance:~      Currently there is no known treatment available for mild memory impairment/MCI, and few~     studies on specific cognitive training in MCI-patients have been performed. The proposed~     study has received funding from a Norwegian Health Region. If computer based training results~     in positive changes to memory functions in MCI patients this may represent a new,~     cost-effective treatment. Secondly, evaluation of training induced structural changes to grey~     or white matter may improve our understanding of the mechanisms behind effective cognitive~     interventions in MCI patients.~   "
120414|NCT01991392|"~     Nasogastric decompression was routinely used in most major intra-abdominal operations.~     Nasogastric tube intubation was thought to decrease postoperative ileus (nausea, vomiting,~     and gastric distension). Would and respiratory complications, and to reduce the incidence of~     anastomotic leaks after gastrointestinal surgery. However, the necessity of nasogastric~     decompression following elective abdominal surgery has been increasingly questioned over the~     last several years. Many clinical studies have suggested that this practice does not provide~     any benefit but could increase patient discomfort and respiratory complications. Furthermore,~     meta-analyses have concluded that routine nasogastric decompression is no longer warranted~     after elective abdominal surgery.~      Elective abdominal surgery without nasogastric decompression was initially tested and then~     widely used on patients with colorectal surgery.However, after upper gastrointestinal~     operations such as gastrectomy, nasogastric has been considered necessary to prevent the~     consequences of postoperative ileus (anastomotic leakage or leaking from the duodenal stump.~     Therefore, studies of gastrectomy without nasogastric tube emerged later than those of~     colectomy. In spite more and more studies reported of no need of nasogastric tube after~     abdominal operation, no papers reported after pancreaticoduodenectomy. Postulated causes of~     lack in studies to assess the need of a nasogastric tube after pancreaticoduodenectomy~     include anticipated prolonged postoperative paralytic ileus caused by PD-related extensive~     destruction and potential risk of gastric stasis after PD. However, our pilot study of~     retrospective analysis of postoperative NG drainage amount in 100 patients recently having PD~     at our hospital showed more than 90% of patients had less than 200cc/day NG drainage amount~     within postoperative day three. Theoretically, these patients might not need a nasogastric~     tube after pancreaticoduodenectomy. Therefore, investigators propose a prospective~     multicenter randomized trial to assess the need of a nasogastric tube after PD.~   "
120415|NCT01991379|"~     The purpose of this study is to evaluate the effects, good and/or bad, of MEK162 and imatinib~     on the patient and on Gastrointestinal Stromal Tumor (GIST).~      Funding Source - FDA OOPD~   "
120416|NCT01991366|"~     The aim of this observational study is to evaluate the in hospital and 6 month outcomes of~     the use of Glycoprotein IIb/IIIa inhibitor eptifibatide as adjunctive therapy in patients~     undergoing primary Percutaneous Coronary Intervention for ST-elevation myocardial infarction~     in a large tertiary referral center.~      It is hypothesized that Glycoprotein IIb/IIIa inhibitor use during primary Percutaneous~     Coronary Intervention for ST-elevation myocardial infarction/ acute myocardial infarction is~     superior to unfractionated heparin alone or bivalirudin alone. Additionally, after propensity~     matching this superiority remains.~   "
120417|NCT01991353|"~     This study will compare meniscal healing with or without platelet rich plasma. The~     assessments will include validated, disease specific, patient oriented outcome measures, MRI~     arthrogram (MRA). Results of this study will help ascertain whether PRP improves meniscal~     healing rates.~      Null Hypothesis: There is no difference in meniscal healing with or without the use of PRP.~   "
120418|NCT01991340|"~     This observational study will assess the safety of Herceptin (trastuzumab) in patients with~     HER2-positive breast cancer in routine clinical practice. Eligible patients will be followed~     for up to 4 years.~   "
120419|NCT01991327|"~     The primary objective of this study is to assess the drug-drug interactions of Androxal with~     cytochrome P450 isoenzymes, CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4 in healthy~     male subjects administered 25 mg Androxal once daily for 3 days. Secondly, the safety and~     tolerability of Androxal will be determined in healthy male subjects administered Androxal 25~     mg daily for 3 days.~   "
120420|NCT01991314|"~     Iron deficiency anaemia is common in inflammatory bowel disease (IBD), affecting at least 20%~     patients at any one time. Hepcidin, a recently described anti-microbial peptide synthesized~     by the liver, is a key regulator of iron homeostasis. It interferes with absorption of iron~     into enterocytes, macrophages and hepatocytes by binding to ferroportin. Hepcidin levels rise~     when total body iron levels rise and protect against iron overload; conversely, in iron~     deficiency, levels are low. Hepcidin levels also rise under the influence of interleukins~     (IL)-6 and -1, a factor likely to contribute to iron deficient erythropoesis in active IBD.~     Whether hepcidin levels predict resistance to oral iron therapy in IBD is unknown, though it~     may impair its immediate oral absorption. Adult IBD patients who are anaemic report quality~     of life and fatigue scores comparable to those seen in malignancy.~      IBD diagnosed in adolescence interferes with growth, education and employment as well as~     psychosocial and sexual development. Not surprisingly, adolescents with IBD have a high~     prevalence of psychological distress, particular depression. Limited historical, and our own~     data suggest that children and adolescents with IBD are more anaemic than adults, and less~     often treated with oral iron. What is not clear is whether the apparent under-utilisation of~     oral iron in paediatric care is because of a perceived lack of benefit or doctors' concerns~     about possible side effects including worsening disease activity.~      To address these questions, the investigators propose a comparative study of 6 weeks of oral~     iron supplementation in adolescents and adults with iron deficiency anaemia in IBD. Patients~     will be given oral iron supplementation. Before and after iron therapy, the investigators~     shall assess haemoglobin concentrations; IBD activity; quality of life (QOL), perceived~     stress, mood and fatigue; iron metabolism, including serum hepcidin.~   "
120421|NCT01991301|"~     The aim of this study is to evaluate the safety and efficacy of Carfilzumib, which is a novel~     biological agent used in the treatment of multiple myeloma in preventing graft-versus-host~     disease, after stem cells transplantation from unrelated donors.~   "
120422|NCT01991288|"~     We hypothesize that preoperative saphenous nerve block (SNB) in combination with~     periarticular local infiltration provides better post operative pain relief (POPR) profile as~     compared to local infiltration alone~   "
120423|NCT01991275|"~     This study will investigate the efficacy and safety of intrathecal morphine for the patients~     undergoing robot-assisted prostatectomy~   "
120424|NCT01991262|"~     Protocol Title: A Nationwide Epidemiological, Non-Interventional Study Evaluating an~     Educational Support Program for Improving Treatment Adherence in Patients with Hepatitis B~     Viral Infection~      Objective(s): The primary objectives of the study are to assess:~        -  HBV treatment adherence rate in patients enrolled in the Support Program~        -  Adherence rates at 6m, 12m.~      The secondary objectives are to assess:~        -  Adverse events rate and profile.~        -  Actual treatment duration and dose taken vs. prescribed.~        -  The impact of SMS reminders.~      Study Design: Eligible patients will be randomized into one of four groups: Group 1 shall~     receive both a weekly phone call from a supporter and a daily SMS reminder. Group 2 will~     receive a weekly phone call only. Group 3 will receive a daily SMS reminder only and group 4~     (Control) shall receive no support.~      Study Population: Adult newly diagnosed with Hep B patients, eligible to begin treatment with~     first line therapy.~      Data Collection Methods:~        1. Supporter's documentations of patient's self assessment.~        2. Drugs dispense data from pharmacies~        3. Pills count.~   "
120425|NCT01991249|"~     Acute leukemias are a heterogeneous group of hematologic malignancies. They result from~     clonal expansion of immature cells whose number is greater than 20% in bone marrow. Childhood~     acute leukemias are the most common pediatric malignancies. In Europe and the United states,~     they represent about 35% of childhood cancers. 80% of them are acute lymphoblastic leukemia~     (ALL) and 15-20% of acute myeloid leukemia (AML). Current treatments allow a cure in about~     80% of ALL, while this level is only 50% in AML.Acute leukemia diagnosis is based on the~     multidisciplinary exploration of leukemia cells by different techniques:~        -  Cellular: cytology, immunophenotyping and cytochemistry~        -  Cytogenetic: conventional (karyotype) and molecular (FISH) cytogenetic~        -  Molecular: RT-PCR and RQ-PCR~      Cytogenetic studies are performed at time of acute leukemia diagnosis. Indeed, the WHO 2008~     classification of acute leukemia is based largely on the presence of recurrent cytogenetic~     and molecular abnormalities. The most frequent chromosomal aberrations have been associated~     with specific clinical and biological characteristics and are now used as diagnosis and~     prognostic markers. These chromosomal abnormalities affect genes involving in the~     leukemogenesis process. These rearrangements are of several types:~        -  Fusion genes causing :~             -  Repression of transcriptional activity of genes involved in differentiation of~               hematopoietic cells (AML1-ETO, PML-RARA…)~             -  Deregulation of signal transduction pathway (eg BCR-ABL chimeric protein with~               constitutive tyrosine kinase activity)~             -  Changing in the state of chromatin condensation resulting changes of transcription~               (MLL gene rearrangements in 11q23, MOZ en 8p11…)~        -  Deregulation of genes expression: chromosomal rearrangements can sometimes induce~          deregulation of adjacent genes to the breakpoint. For example, inv(3)(q21q26) or~          t(3;3)(q21;q26) induce over expression of transcriptional factor EVI-1.~        -  Loss of function due to deletion of variable size in genomic regions containing genes~          with a role in the differentiation, apoptosis, or cell proliferation (eg IKZF1, PAX5…)~      In addition to the karyotype, which allows to have a global view of the genome; FISH, a~     targeted technique, is used to highlight invisible abnormalities on karyotype (cryptic~     abnormalities) or the time of karyotype failure. However, conventional and molecular~     cytogenetic techniques do not highlight any abnormalities (eg different partners involved in~     the formation of fusion genes in particular for MLL gene rearrangement, mutations) hence our~     interest in next generation sequencing.Indeed, the high throughput targeted sequencing~     messenger RNAs (RNA-seq) has the avantage of allow identification of different types of~     mutations in a single test, with exception of epigenetic mutations. The importance of RNAs~     sequencing rather than DNA genomic is the one hand, a very significant decrease in the volume~     of sequences to analyze because transcribed mRNA genes represent about 5% of the genome size~     and secondly, a better identification of chimeric genes. The RNA-seq has used as a research~     tool in hematologic malignancies. The purpose of this project is to use innovative technology~     to develop a new diagnostic and prognostic new tool in hematological malignancies. 50 acute~     leukemias will be tested and results will be analyzed according to three criteria:~        -  Quantity, quality and relevance of information provided for the diagnosis, monitoring~          and therapeutic management compared to a conventional strategy~        -  Period required to obtain results and methods to decrease the analysis time so that~          results can be integrated into therapeutic decisions.~        -  Economic evaluation, which will calculate the cost of this diagnosis option and assess~          the cost/benefit ratio In future, other innovative approaches will be implemented (study~          of imbalances genomic abnormalities by array-CGH, transcriptome analysis with~          micro-array, and study of methylome) to identify the molecular signature of each~          leukemia and set of informative abnormalities for diagnosis, prognosis and treatment of~          disease and monitoring of residual disease.~   "
120426|NCT01991236|"~     1.0 Title: The Efficiency and Effectiveness of Video-Based Education for Dermatology~     Patients Qualifying for Chronic Treatment with Systemic Corticosteroids~      2.0 Background: Past studies have shown that the use of educational videos has been effective~     in increasing patient education and satisfaction. These studies suggest that such video tools~     may enable an office to be significantly more efficient.~      3.0 Objective: The Emory University Department of Dermatology has created an educational~     video as part of clinical care. The objective for Phase I of the study is to collect~     information about dermatology patients' baseline knowledge about corticosteroid and/or~     corticosteroid sparing medication treatment using an online (or written copy) questionnaire.~     The objective for Phase II of the study is to determine the effect of a video on dermatology~     patient knowledge. The objective for Phase III of the study is to determine the office~     efficiency of the video in patients requiring long-term oral corticosteroid and/or~     corticosteroid sparing medications. Secondary objectives of the study are to determine~     patient and physician satisfaction with the video as an educational tool.~      4.0 Patient Selection: Phase I and Phase II: Patients who arrive to clinic during a~     participating physician's clinic day at the Emory Dermatology Department. Phase III: Patients~     who require treatment with long term oral corticosteroids at the Emory University Department~     of Dermatology Clinic as determined by their treatment physician.~      5.0 Recruitment: All patients arriving to clinic on a study day will be given an~     informational opt-out sheet. All patients will be eligible to complete Phase I and Phase II:~     (steroid questionnaire only and steroid video or verbal education plus questionnaires). Only~     patients who require long term oral corticosteroid treatment will proceed to Phase III: of~     the study. Physicians will be recruited from the Emory Dermatology Department.~      6.0 Assessment: Patients in Phase I will complete to the pre-education questionnaire online~     (or a written copy). Their results will be compared with baseline results from patients in~     Phase III: who undergo treatment with steroids. Patients in Phase II or III will be~     randomized to two groups. Control patients will receive verbal discussion of corticosteroid~     treatment. Phase II control patient education will be using a script developed by study~     physicians and delivered by study personnel. Phase III patients who qualify for long term~     systemic steroid will have verbal education by their doctor as usual. Video patients will~     receive an educational video instead, and will write down any remaining questions after~     viewing for their doctor to address as soon as possible. After verbal or video education,~     both groups will take a post-education questionnaire and patient satisfaction surveys online.~     Phase II is then complete. In Phase III, both groups will follow-up at least 1, 3, and 6~     months after beginning treatment. At follow-up, their doctor will ask about current~     corticosteroid dose and frequency, willingness to transition to a steroid-sparing method, and~     compliance with preventative measures during treatment. Patients will complete the same~     post-education questionnaire online again at these visits. Physicians will also complete~     satisfaction surveys online at 1, 3, and 6 months from study start, and then every 6 months.~      6.1 Sample size: The sample size for Phase I is unlimited until the last Phase II patient~     completes enrollment. Emory plans to recruit a total of 80 patients to participate in Phase~     II of this study (40 per group).~      6.2 Participant time burden: Phase I only: 5-10 minutes Phase II and III: 30-35 minutes~     Physicians: 20 minutes~   "
120427|NCT01991223|"~     To evaluate the efficacy of dexmedetomidine for the prevention of catheter-related bladder~     discomfort~   "
120428|NCT01991210|"~     This randomized, multicenter, open-label study will evaluate the safety and efficacy of~     DNIB0600A (RO5541081) in comparison with PLD in participants with PROC, primary peritoneal~     cancer or fallopian tube cancer. Participants will be randomized to receive either DNIB0600A~     2.4 milligrams per kilogram (mg/kg) intravenously (IV) every 3 weeks or PLD 40 milligrams per~     meter-squared (mg/m^2) IV every 4 weeks.~   "
120429|NCT01991197|"~     The primary purpose of this study is to determine if sitagliptin (Januvia®) improves~     psoriasis severity after 16 weeks of treatment in 20 participants with both psoriasis and~     type 2 diabetes mellitus. We will compare the change in psoriasis severity in 20 participants~     treated with Januvia® to 20 participants treated with 16 weeks of a comparator drug~     (gliclazide, Diamicron®). Participants will be recruited from two centres and after a 4 week~     washout period will be followed prospectively for 36 weeks. Participants will be stratified~     by centre, psoriasis severity and obesity status after which they will be randomly allocated~     to Arm A or Arm B. Participants will be treated with either Januvia® and Diamicron® matched~     placebo capsules (Arm A), or Diamicron® and Januvia® matched placebo tablets (Arm B) for 16~     weeks and then proceed to an open-label phase where all participants will receive Januvia®~     for a further 16 weeks.~      Both the research participants and the investigators will be unaware of the trial arm to~     which the research participant has been allocated (double-blind study). Research participants~     will be prohibited from making any changes to the dose of medications used to treat~     psoriasis. If a participant's plasma glycated haemoglobin level (HbA1c) (reflects a~     participant's glucose control over the previous 3 months) is above 64mmol/mol eight weeks~     after commencing one of the study investigational medicinal products (IMPs) insulin therapy~     will be used to improve glycaemic control.~      Participants will be assessed at 9 study visits over 40 weeks. Participants will complete~     questionnaires, have a medical history recorded and physical examination, blood sampling and~     skin biopsies taken (in a small number of willing participants at 3 visits).~      The following endpoints will be analysed:~      Changes in psoriasis severity at 16 and 32 weeks; changes in validated quality of life~     scores; incidence of adverse events; incidence of discontinuation of one of the study IMPs,~     time to relapse of psoriasis; changes in cardiovascular disease risk factor profiles; changes~     in cytokines, hormones, expression of immune proteins in blood and skin biopsies; and genetic~     profiles that predicts best response to sitagliptin therapy.~      We hypothesize that sitagliptin therapy decreases psoriasis severity.~   "
120430|NCT01991184|"~     This open-label, Phase I study will evaluate the safety, tolerability, and pharmacokinetics~     of increasing doses of GDC-0853 in patients with relapsed or refractory B-cell non-Hodgkin's~     lymphoma or chronic lymphocytic leukemia. In a dose-expansion part, GDC-0853 will be assessed~     in subsets of patients.~   "
120431|NCT01991171|"~     Forty-eight female patients will be randomized into three groups to receive the Kinesio~     taping, placebo Kinesio taping and control group. The group Kinesio taping receive the~     correct application of the method described. The placebo group will receive a placement~     without tension. The control group did not receive any form of intervention.~   "
120432|NCT01991158|"~     The purpose of this study is to evaluate the efficacy and safety of High dose of Methotrexate~     combined with gemcitabine, pegaspargase and dexamethasone (GAD-M regimen) as first-line~     treatment in patients with de novo extranodal NK/T cell lymphoma.~   "
120433|NCT01991145|"~     This randomized controlled study aims to evaluate the efficacy and safety of allogeneic~     umbilical cord blood therapy combined with erythropoietin for children with cerebral palsy.~   "
120441|NCT01991041|"~     This is a registry study, where sites will enter patients with LGS who require a modification~     in anti-epileptic therapy (either the addition of another anti-epileptic drug, or the change~     of one drug to another). This will include patients who are started on rufinamide. Patients~     will be reviewed according to local practice, but it is envisaged that review will occur at~     approximately one month, three months and six months, and then every six months. Upon entry~     to the registry baseline details concerning disease severity, diagnosis, prior therapy, and~     developmental assessment will be recorded. On each subsequent visit the patient (usually~     through their caregiver) will be asked about current medication, general seizure profile, any~     seizures deemed to be of medical significance, tolerability, AEs (including suicidal-related~     events), and healthcare resource utilisation.~   "
120434|NCT01991132|"~     Non-contact meibography is a useful tool in assessing the health of meibomian glands in~     patients. Instead of using normal light in contact meibography, non-contact meibography~     utilises infra-red (IR) light. IR light is shined on patients' inverted eyelids and a special~     camera then allows visualisation of the structure of the meibomian glands, including the~     ducts and acini. Currently, images taken via non-contact meibography are manually analysed by~     a skilled clinician.~      Knowledge of the health of meibomian glands is useful, especially in the diagnosis of~     Meibomian Gland Dysfunction (MGD). Studies have shown that MGD is one of the most common~     causes of evaporative dry eye.~      Mediview 2.0 is a software that has been programmed to semi-automatically classify meibograph~     images taken via non-contact meibography. This software is collaboration with Shanghai~     MediWorks Precision Instruments Co., Ltd. The algorithm used was developed by a collaboration~     between Agency for Science, Technology and Research (A*STAR) and Singapore Eye Research~     Institute (SERI).~      This current study aims to validate the diagnostic accuracy of Mediview 2.0 in assessing the~     health of meibomian glands of patients, against a trained clinician. We aim to recruit 100~     participants for this study.~      Once this software is found to be valid, a trained technician could be taught how to capture~     the images and hence leaving the doctors with more time to focus on clinical assessment and~     treatment instead. Therefore, this study has the potential to increase efficiency in the~     clinics.~   "
120435|NCT01991119|"~     the purpose of this study is to compare the ability of propafenone and dronedarone to~     maintain sinus rhythm after DC cardioversion~   "
120436|NCT01991106|"~     The prevalence of paediatric obesity has increased over the last two decades and with it, an~     increased diagnosis of lifestyle-related diseases in children and adolescents. High intensity~     interval training has recently been explored as an alternate to traditional aerobic exercise~     in adults with chronic disease and has potential to induce rapid reversal of subclinical~     disease markers in obese children and adolescents.~      High intensity interval training has recently been explored as an alternate to traditional~     aerobic exercise in adults with chronic disease and has potential to induce rapid reversal of~     subclinical disease markers in obese children and adolescents.~      Goal: The primary aim of this randomised controlled trial is to evaluate the effectiveness of~     a high intensity interval training intervention on myocardial function, vascular function and~     visceral adipose tissue in obese children and adolescents at baseline, three and twelve~     months.~      Method: Multi-centre randomised controlled trial of 100 obese children and adolescents in the~     cities of Trondheim (Norway) and Brisbane (Australia). Participants will be randomised to (1)~     high intensity interval training, (2) moderate intensity continuous training or (3) nutrition~     advise. Participants will partake in supervised exercise training and/or nutrition~     consultations for 3 months. Measurements for all study endpoints will occur at baseline, 3~     months (post intervention) and 12 months (follow up).~      Scientific Significance : This randomised controlled trial will general substantial~     information regarding the effects of exercise intensity on paediatric obesity, specifically~     the cardio-metabolic health of this at-risk population. It is expected that communication of~     results will allow for more robust and realistic guidelines regarding exercise prescription~     in this population to be formed while outlining the benefits of high intensity interval~     training on subclinical markers of disease.~   "
120437|NCT01991093|"~     Antiplatelet therapy with aspirin-clopidogrel reduces the risk of cardiovascular episodes~     after percutaneous coronary intervention (PCI) in patients with acute coronary syndromes.~     However, a significant number of patients experience recurrent events while on such therapy.~     The individual response to dual antiplatelet therapy is not uniform, and consistent findings~     across multiple investigations support the association between a lower degree of platelet~     inhibition, high on-treatment platelet reactivity, and the occurrence of atherothrombotic~     events [1, 2]. Particularly in diabetic patients, clopidogrel resistance is more prevalent~     compared with non-diabetics [3,4], which seems to contribute to the increased~     atherothrombotic risk in these patients compared with those without diabetes mellitus (DM)~     [5]. A number of platelet function instruments have now become available that are simple to~     use and can be utilized as point-of-care (POC) instruments in order to monitor antiplatelet~     therapy and potentially assess the risk of a recurrent event [6].~   "
120438|NCT01991080|"~     The immune system plays an important role in the fight against cancer. According to certain~     studies, Levels of cytokines secreted by the immune cells were found as predictors of~     prognosis and survival among cancer patients, as well as disease recurrence. Previous~     studies, including meta-analyses, reported that chronic emotional stress or depression were~     associated with higher levels of pro-inflammatory cytokines. Practicing relaxation was found~     to decrease psychological symptoms among cancer patients, such as depression, anger,~     hostility and anxiety symptoms, as well as physical symptoms.~      Wheatgrass juice is an extract squeezed from the mature sprouts of wheat seeds (Triticum~     aestivum). Currently, there are only a few laboratory and medical studies that examine the~     beneficial effects of wheatgrass consumption. Controlled clinical trials have found that~     wheatgrass juice may reduce chemotherapy-induced myelotoxicity, accompanied by fever and~     infection without harming the chemotherapy effectiveness among breast cancer patients6.~      Aims~        1. To examine the differences in immune measures (serum and micro-particles levels of the~          cytokines IL-6, IL-8, IL-10 and IL-12), and in physical and psychological well-being~          measures (anxiety, depression, pain, fatigue, nausea) at three time points and between~          two intervention methods (biofeedback-assisted relaxation and wheatgrass consumption)~          and between the intervention groups vs. a control group, among colorectal cancer~          patients.~        2. To assess the mediating role of optimism, perceived control and well-being measures~          (anxiety, depression, pain, fatigue, nausea) among colorectal cancer patients in the~          relations between the interventions (biofeedback-assisted relaxation and wheatgrass~          consumption) and the immune measures (serum and micro-particles levels of cytokines~          IL-6, IL-8 IL-10 and IL-12 ), and the mediating role of well-being measures on the~          relations between optimism and perceived control with immune measures.~      Methods Participants will include 120 colorectal cancer patients aged 18+, with Eastern~     performance status of ≤ 2 and disease stage II or III, who receive adjuvant chemotherapy of~     Capcitabine or FU-5 treatment, conjoined with Oxaliplatin, or Capcitabine alone following~     curative surgery at Rambam Health Care Campus. The estimated number of participants was~     calculated based on Green's equation (1991): 50+8X 7 A comparison between the two treatment~     groups, as well as a comparison between each treatment group and the control group (80~     subjects) will allow inclusion of up to four background parameters in each of the~     regressions, according to Green's equation.~   "
120439|NCT01991067|"~     Patients undergoing allogeneic blood and marrow transplantation (HSCT) experience a prolonged~     period of dysfunctional immunity. Systematic reimmunization is necessary at appropriate time~     intervals following transplantation to re-establish immunity. Vaccination practices after~     HSCT remain varied and data sparse. Tick-borne encephalitis (TBE) is one of the most severe~     infections of the central nervous system caused by a tick-borne flavivirus. There is no~     specific treatment, and prevention with the vaccine is the only intervention available. To~     assess the efficacy of TBE vaccination in adult allogeneic HSCT recipients compared to an~     age-matched and sex-matched control group of healthy volunteers without previous TBE~     vaccination, a prospective open-label phase II pilot study on humoral and cellular immune~     responses after use of TBE vaccine (FSME Immun) will be performed. As primary end point the~     outcome of the neutralization test (NT) against TBE will be assessed in a total of 26 HSCT~     patients one year after HSCT and in 26 healthy volunteers, namely four weeks after the second~     vaccination. Therefore, the number of subjects with NT titres against TBE virus >10, assumed~     to be the threshold for antibody-mediated protection will be evaluated. As secondary~     endpoints, antibody concentrations of TBE enzyme-linked immunosorbent assay before and four~     weeks after the second and third vaccination and antibody concentrations of NT against TBE~     four weeks after primary immunization. To evaluate cellular immune responses, lymphocyte~     proliferations assays and cytokine detection assays will be performed. In a subgroup~     analysis, these secondary endpoints will be compared between healthy volunteers, HSCT~     patients without immunosuppressive treatment and HSCT patients receiving immunosuppressive~     agents. Additionally, immune reconstitution by analysis of peripheral blood lymphocyte~     subsets and serum immunoglobulin levels will be evaluated prior to vaccination, after twelve~     weeks and prior to the third vaccination in HSCT patients only.~   "
120440|NCT01991054|"~     Vitamin D plays a key role in keeping normal mineral balance and maintaining bone health.~     There is accumulating evidence linking deficient vitamin D status with both type 1 and type 2~     diabetes.~      The purpose of this study is to evaluate the effect of high dose vitamin D supplementation~     (120000 units per month)for 6 months on glucose homeostasis and glycemic control,in vitamin D~     deficient patients with non-optimally controlled type 2 diabetes mellitus.~   "
120442|NCT01991028|"~     OligoG is a new potential treatment which is being developed by AlgiPharma AS (a~     Norwegian-based company) with an aim to help people with cystic fibrosis in the future.~      OligoG, derived from marine algae, is expected to act locally in the lungs once inhaled to~     reduce mucus thickness and improve mucus clearance. It could also have the benefit of~     reducing the incidence of infections.~      Nebulised doses of up to 540 mg/day have been administered to healthy volunteers for three~     consecutive days and to cystic fibrosis patients for 28 consecutive days. Both groups~     tolerated the medication well, with no treatment related issues reported. The dose~     administered in this study is lower; patients who complete the study will receive, in total,~     186 mg of OligoG in two divided doses.~      A new dry powder formulation of OligoG has been developed so that patients can use an~     inhaler, rather than a nebuliser. Administration from an inhaler compared to a nebuliser is~     much quicker and more practical for the patient.~      In this study, we will use gamma scintigraphy to see where in the lungs the dry powder and~     nebulised solution go after being inhaled by cystic fibrosis patients. Gamma scintigraphy is~     a well-established medical imaging technique. A small amount of radioactive material will be~     added to both the dry powder and nebulised solution. The radiation emitted will then be~     detected by taking images using a device known as a gamma camera. The procedure is relatively~     easy and non-invasive.~      The purpose of this study is to help answer the following research questions:~        -  How do the OligoG dry powder and nebulised solution distribute in the lungs of patients~          with cystic fibrosis?~        -  How much of the formulation gets to the deep lung?~        -  How much of the formulation remains in the devices used for administration?~   "
120443|NCT01991015|"~     The goal of this study is to better understand gender differences in end-of-life~     communication between physicians and patients with advanced cancer in the hospital.~   "
120444|NCT01991002|"~     The scientific literature shows a quantitative relationship between diet combined with~     physical activity as a long term weight reduction modality and an important factor in weight~     maintenance.~      Primary assumption - the 14/21 diet will have an impact on BMI values, and their long-term~     maintenance.~      Secondary assumption - the 14/21 diet will have a positive impact on anthropomorphic and~     biochemical markers, on blood pressure, resting heart rate, RMR, and life quality.~   "
120445|NCT01990989|"~     The aim of the present study is to evaluate candidate variables,including Cytochrome P450~     2C19(CYP2C19) genotypes, clinical and demographic variables,to establish a simple risk score~     that can be easily adopted by clinicians to identify patients who are at risk for HPR and~     composite cardiovascular outcomes in Chinese Han patients treated with dual antiplatelet~     therapy.~   "
120446|NCT01990976|"~     The safety of guided practice of physical activity in myopathies is increasingly accepted,~     including muscular dystrophies. In facioscapulohumeral dystrophy (FSHD), one of the most~     common muscular dystrophy, the aerobic training showed its physiological and functional~     efficiency without affecting the quality of life of patients. The issue of exercise therapy~     extended to all neuromuscular diseases, as has been rigorously analyzed, shows that the use~     of a training program combining endurance exercise targeted exercises and strength is even~     more relevant.~      To complete the multidimensional assessments be managed by each team ( physiological~     assessments, functional tissue and quality of life) it is relevant to continue , for a~     descriptive study quantitative and qualitative analyzes by muscle imaging and spectroscopy~     (MRI and Nuclear Resonance Imaging (NMR) spectroscopy ).~   "
120447|NCT01990963|"~     Processing the Digital Imaging and COmmunications in Medicine (DICOM) of tomographic using~     Mannheim Lung Analyzing software (MALUNA®) , to obtain volumetrical and densitometric data of~     brain tissue after patients with severe brain trauma~   "
120448|NCT01990950|"~     This post-market study is approved by the US FDA to evaluate the long-term safety and~     performance of the Zenith® Fenestrated AAA Endovascular Graft.~   "
120449|NCT01990937|"~     Can oral midazolam used for sedation in patients undergoing upper gastrointestinal endoscopy~     ?~   "
120450|NCT01990924|"~     Objectives: To determine the efficacy of low rate fluoroscopy at 7.5 frames per second (FPS)~     vs. conventional 15 FPS for reduction of operator and patient radiation dose during~     diagnostic coronary angiography and percutaneous coronary intervention via the transradial~     approach.~      Background: Transradial approach for cardiac catheterization is potentially associated with~     increased radiation exposure. Low rate fluoroscopy has potential to reduce radiation~     exposure.~   "
120451|NCT01990911|"~     The autonomic nervous system plays an important role in the precipitation of AF in~     structurally-abnormal hearts. Restoration of autonomic imbalance may therefore prevent~     new-onset AF.~      Renal artery denervation (RDN) is a novel percutaneous procedure that uses radio-frequency~     energy to destroy the sympathetic renal nerves. Symplicity 1 and -2 studies have shown that~     RDN effectively reduces blood pressure in up to 80% of treated patients. LVH regression and~     improvement of diastolic dysfunction follow as a consequence of afterload reduction and~     renin-angiotensin-aldosterone system modulation. RDN may thus also reduce intra-atrial~     pressure resulting in less stretch of the pulmonary venous ostia where most ectopic AF-foci~     originate.~      Hypothesis: RDN restores autonomic imbalance in HTHD and lowers intra-atrial pressure by~     reducing afterload. These synergistic mechanisms may prevent new-onset AF.~   "
120452|NCT01990898|"~     This is a study for patients that have a condition called Interstitial Cystitis, also known~     as Painful Bladder Syndrome. Patients would have tried at least two different therapies,~     unsuccessfully,(eg. medications, pelvic floor physical therapy)~      The purpose of this research project is to study the immunosuppressive drug Cyclosporine in~     patients with Interstitial Cystitis to assess how well it works, what the side effects are~     and what is its mechanism of action. Cyclosporine is a drug that is FDA-approved to prevent~     organ rejection after kidney, liver, and heart transplant but is not approved by the FDA for~     Interstitial Cystitis. Several research studies have been published showing that Cyclosporine~     can improve the symptoms of Interstitial Cystitis, that it works better than a placebo~     (sugar pill or inert treatment) and that it works more effectively than Pentosan~     Polysulfate (Elmiron), which is an FDA approved therapy. The dose of Cyclosporine used in~     these studies on Interstitial Cystitis are much lower that the doses used to prevent~     rejection in transplant patients.~      Based on these studies, the American Urological Association has recently published treatment~     guidelines that recommend Cyclosporine therapy for Interstitial Cystitis after the failure of~     other more conservative therapies and medications. Nevertheless, much is not known about~     using Cyclosporine therapy for Interstitial Cystitis including the mechanism of action, the~     ideal dose, how best to monitor for side effects and in particular whether kidney damage can~     occur at the low doses used in these studies. In this study, to examine the mechanism of~     action, blood and urine samples will be collected before, during and after therapy to look at~     biomarkers, chemical substances that can be associated with inflammation and tissue injury.~     We will also test effects of therapy on skin sensation and pain perception because the~     molecule which Cyclosporine binds to (calcineurin) is also found in nerves that conduct pain~     signals.~      This study is only being done at the Cleveland Clinic and will involve about 30 patients with~     Interstitial Cystitis.~   "
120457|NCT01990833|"~     For non-healing ulcers, abnormal periods of wound healing processes: inflammation,~     proliferation and remodelling, are believed to lead to chronic wounds. As a chronic stalled~     wound, investigators hypothesized that these glue-assisted closure (GAC)-failed~     enterocutaneous fistula (ECF) might have a prolonged inflammatory phase modulated by~     excessive pro-inflammatory cytokines or proteases. The aim of this study was to analyze the~     chemicals in ECF wounds in order to determine patients' condition and fitness for GAC.~   "
120458|NCT01990820|"~     Chronic rhinosinusitis, a common diagnosis in children, remains a poorly understood disease.~     Adenoidectomy (surgery to take out the adenoid pads- infection fighting glands in the back of~     the throat) is performed since the adenoid pad may trap germs that enter a child's body and~     can get so swollen with bacteria that they become infected themselves. Functional endoscopic~     sinus surgery (FESS) and adenoidectomy are currently the most common surgeries performed on~     children with this disease. Another treatment is adenoidectomy and irrigation of the~     maxillary sinus without FESS. New technology has emerged using a balloon catheter to dilate~     (open) the sinus passage in addition to the adenoidectomy and irrigation. This study seeks to~     answer if children with chronic rhinosinusitis who undergo adenoidectomy with balloon~     dilation of the maxillary sinus passage and irrigation experience improved quality of life~     outcomes compared to children with chronic rhinosinusitis who undergo an adenoidectomy with~     maxillary sinus irrigation without dilation of the sinus passage.~   "
120459|NCT01990807|"~     The cure rate for childhood acute lymphoblastic leukemia (ALL) has increased significantly in~     recent decades and expected cure rates now exceed 85%. In recent years, Tyrosine Kinase~     Inhibitor(TKI) has improved outcome of Philadelphia chromosome positive (Ph+)ALL . But in~     some high risk groups, The prognosis of patients is still very bad and the relapse rate is~     high. Clearly, new therapies are urgently needed to prevent and /or treat relapsed ALL.~   "
120460|NCT01990794|"~     The purpose of this study is to investigate steady-state cobalt levels following dietary~     supplementation for 90 days with 1 mg cobalt/day (as cobalt chloride in solution) in healthy~     adult volunteers.~   "
120461|NCT01990781|"~     Post operative sore throat (POST) following tracheal intubation is a common problem causing~     dissatisfaction and discomfort to the patients. Prophylactic use of both lidocaine and~     dexamethasone has been used independently for this purpose. However, there is no study~     assessing the synergistic analgesic effects of lidocaine and dexamethasone for POST. The~     purpose of this study is to compare the effect of lidocaine, dexamethasone and lidocaine~     dexamethasone combination on the incidence and severity of POST.~   "
120462|NCT01990768|"~     Primary aim: To determine the efficacy of two dosing regimens of TXA initiated in the~     prehospital setting in patients with moderate to severe TBI (GCS score ≤12).~      Primary hypothesis: The null hypothesis is that prehospital administration either of two~     dosing regimens of TXA in patients with moderate to severe TBI will not increase the~     proportion of patients with a favorable long-term neurologic outcome compared to placebo,~     based on the GOS-E at 6 months.~      Secondary aims: To determine differences between TXA and placebo in the following outcomes~     for patients with moderate to severe TBI treated in the prehospital setting with 2 dosing~     regimens of TXA:~        -  Clinical outcomes: ICH progression, DRS at discharge and 6 months, GOS-E at discharge,~          28-day survival, frequency of neurosurgical interventions, and ventilator-free,~          ICU-free, and hospital-free days.~        -  Safety outcomes: Development of seizures, cerebral ischemic events, myocardial~          infarction, deep venous thrombosis, and pulmonary thromboembolism.~        -  Mechanistic outcomes: Alterations in fibrinolysis based on fibrinolytic pathway~          mediators and degree of clot lysis based on TEG.~      Inclusion: Blunt and penetrating traumatic mechanism consistent with TBI with prehospital GCS~     ≤ 12 prior to administration of sedative and/or paralytic agents, prehospital SBP ≥ 90 mmHg,~     prehospital IV or intraosseous (IO) access, age ≥ 15yrs (or weight ≥ 50kg if age is unknown),~     EMS transport to a participating trauma center.~      Exclusion: GCS=3 with no reactive pupil, estimated time from injury to hospital arrival >2~     hours, unknown time of injury, clinical suspicion by EMS of seizure activity or known history~     of seizures, acute MI or stroke, CPR by EMS prior to randomization, burns > 20% TBSA,~     suspected or known prisoners, suspected or known pregnancy, prehospital TXA given prior to~     randomization, subjects who have activated the opt-out process when required by the local~     regulatory board.~      A multi-center double-blind randomized controlled trial with 3 treatment arms:~        -  Bolus/maintenance: 1 gram IV TXA bolus in the prehospital setting followed by a 1 gram~          IV maintenance infusion initiated on hospital arrival and infused over 8 hours.~        -  Bolus only: 2 grams IV TXA bolus in the prehospital setting followed by a placebo~          maintenance infusion initiated on hospital arrival and infused over 8 hours.~        -  Placebo: Placebo IV bolus in the prehospital setting followed by a placebo maintenance~          infusion initiated on hospital arrival and infused over 8 hours.~   "
120463|NCT01990755|"~     Background. Treatments of eating disorders result too often in partial psychological and~     physical remission, chronic course, dropout, relapse and death, with no fully known~     explanations for this failure. In order to clarify this problem, we conducted a three~     branches study to identify the biochemical background of cognitive-behavioral psychotherapy~     (CBT), individual psychology brief psychotherapy (IBPP), and psychotherapy-pharmacotherapy~     with CBT+olanzapine in anorexics (AN) and bulimics (BN) by measuring the levels of plasma~     homovanillic acid (HVA) for dopamine secretion, plasma 3-methoxy-4-hydroxy-phenylglycol~     (MHPG) for noradrenalin secretion, and platelet [3 Hydrogen]-Paroxetine-binding Bmax and Kd~     for serotonin transporter function. The data were then compared with psychopathological and~     physical alterations. Methods. Branch 1 investigated the effects of 4 months of CBT on plasma~     HVA, MHPG and [3 Hydrogen]-Par-binding in 14 AN-restricted, 14 AN-bingeing/purging, and 22 BN~     inpatients. Branch 2 investigated the effects of 4 months of IBPP on plasma HVA in 15 AN and~     17 BN outpatients. Branch 3 investigated the effect of 3 months of CBT+olanzapine (5 mg/day)~     in 30 AN outpatients. The data are analyzed using one-way ANOVA for repeated measures for the~     changes between basal and post-treatment biological and psychological parameters, two-way~     ANOVA for repeated measures for the differences in the psychobiological data in the 3 groups,~     Spearman's test for the correlations between basal and final changes in the psychological and~     biological scores.~   "
120464|NCT01990742|"~     One in three Americans dies in a nursing home (NH) or in a hospital, shortly following~     transfer from a long-term care facility. The proportion of deaths occurring in NHs is~     projected to increase to 40% by 2020. Excellence in palliative and end-of-life (EOL) care~     must become a priority for these long-term care institutions. However, findings from NHs~     point to high incidence of pain and poor management of other symptoms and excessive reliance~     on hospitalizations, indicating inadequate EOL care quality. Expert opinion and research have~     suggested that poor EOL quality in NHs may be due to lack of palliative care training among~     staff and absence of EOL care protocols or guidelines, but research demonstrating that~     attention to these factors improves outcomes is absent. While dedicated care teams have been~     shown to improve outcomes for NH residents in need of specialized care, the impact of~     palliative care teams in improving resident outcomes has remained largely unstudied and~     untested. This will be the first randomized controlled trial to evaluate the impact of~     palliative care teams (PCTeam) on resident and staff outcomes, and care processes, in NHs.~      Our objective is to demonstrate, using a randomized controlled trial design and a difference~     in difference analytic approach, that nursing home-based palliative care practice guidelines~     implemented through PCTeams will improve quality of care processes and outcomes for residents~     at the end of life.~      We will adapt existing palliative care guidelines for EOL care, endorsed by the National~     Quality Forum (NQF), to the NH environment, deploy the adapted practice guidelines through a~     PCTeam model, and evaluate the effectiveness of this intervention on resident EOL outcomes~     and staff care processes and outcomes. The specific aims (SA) will address the following~     questions:~      SA 1: Is PCTeam intervention effective in improving NH residents' EOL outcomes?~      SA 2: Is PCTeam intervention effective in improving NH staff EOL care processes and outcomes?~      In the context of these specific aims we will test the following hypotheses:~      H1: Residents in NHs in the intervention arm, compared to the control, will achieve better~     EOL risk-adjusted outcomes and care processes with regard to:~        -  Pain~        -  Dyspnea~        -  Depression~        -  In-hospital deaths~        -  Hospitalizations~        -  Advance directives~      H2: Direct care staff in NHs in the intervention arm, compared to the control, will achieve~     better EOL processes and outcomes measured by:~        -  Assessment of EOL symptoms~        -  Delivery of EOL care~        -  Communication/coordination among providers~        -  Communication with residents/families~        -  Teamwork effectiveness~        -  Staff satisfaction~      H3: Family caregivers of decedent residents in the intervention NHs, compared to the control,~     will report receiving more patient and family centered care as measured by higher levels of~     satisfaction with:~        -  Shared decision making between providers, the patient and the family~        -  Care that is respectful of the patient wishes and dignity~        -  Attention to the emotional and spiritual needs of the family.~           31 NHs in upstate New York have been recruited for the study (letters of support).~          Stakeholders include residents, family members, staff, policy makers, and others. The~          intervention will deploy theTeamSTEPPS, a team development model created by the~          Department of Defense and the Agency for Healthcare Research and Quality.~   "
120465|NCT01990729|"~     To study the safety and efficacy of ARTRA (glucosamine chondroitin sulfate) in the treatment~     of non-specific low-back pain of lumbosacral localization in ambulatory care.~   "
120466|NCT01990716|"~     We will quantify one of the lipid compounds (5,6 epoxy eicosatrienoic acid (5,6 EET), 5,6-~     EpoxyEicosaTrienoic acid) in colonic biopsies of Inflammatory Bowel Disease patients. We will~     evaluate its possible use as a pathological activity biomarker and its potential as a~     therapeutic target.~      We hypothesized that 5,6-EET is present in human colonic tissues in varying quantities~     depending on the pathological state of the IBD patient.~   "
120467|NCT01990703|"~     We are studying the effect of placing the levonorgestrel IUD (Mirena) immediately after birth~     on breastfeeding. Women who wish to have a levonorgestrel IUD placed after their birth, wish~     to breastfeed, and are willing to participate in the study will be randomly assigned to~     either get the IUD placed immediately after delivery of the baby and placenta or 4-6 weeks~     later. We do not believe there will be a difference in breastfeeding 8 weeks after delivery~     between those who get the IUD placed early or later.~   "
120468|NCT01990690|"~     To predict the effect of antioxidants in cases of oligohydramnios~   "
120470|NCT01990664|"~     This study is an open-label, multi-site study. The total number of subjects was 200. The~     duration of this study was approximately four weeks. The primary objective was to assess what~     percentage of lapsed contact wearers, who have discontinued use of their contact lenses for~     greater than six months can be successfully re-fit with senofilcon A, reusable 2-weekly~     replacement daily wear lenses (spherical and toric designs).~   "
120471|NCT01990651|"~     The purpose of this study is to assess whether the detection of circulating tumor cells (CTC)~     could be used as a tool to earlier diagnose, more accurately predict treatment response /~     failure and predict overall survival in non-small cell lung cancer (NSCLC) patients~   "
120472|NCT01990638|"~     The purpose of this study was (1) to compare the peak exercise capacity and left ventricular~     diastolic function between patients with and without diabetes and (2) to investigate the~     interrelation among peak oxygen consumption, left ventricular diastolic function, blood~     sugar, and lipid profile.~   "
120473|NCT01990625|"~     In many low-income countries, the use of ultrasound by medical officers and non-physician~     health care staff (e.g., midwives) for antenatal identification of high risk pregnancies is a~     new intervention requiring authoritative investigation. The primary hypothesis to be assessed~     in this study is that antenatal ultrasound screenings performed by medical officers and~     non-physician health care staff will significantly reduce a composite outcome consisting of~     maternal mortality and maternal near miss, stillbirth and neonatal mortality in low-resource~     settings. Underpinning this hypothesis are two assumptions. The first assumption is that~     antenatal detection of complicated pregnancies will lead to appropriate referral at the right~     time for complicated pregnancies to comprehensive emergency obstetric and neonatal care~     (EmONC) facilities. The second assumption is that ultrasound's introduction will increase~     antenatal attendance leading to greater rates of institutional delivery. To assess these~     underlying assumptions beyond the composite end point, this study will investigate the health~     system impact of compact ultrasound. Secondary outcomes include antenatal attendance rates,~     institutional delivery rates at basic EmONC facilities, referral rates to comprehensive EmONC~     facilities, cesarean section rates (both planned and emergent) and an assessment of medical~     officers and non-physician health care provider ultrasound competence and training quality.~   "
120474|NCT01990612|"~     A randomized clinical trial to assess whether elective induction of labor at 39 weeks of~     gestation compared with expectant management will improve outcomes.~   "
120475|NCT01990599|"~     Airway management of patients undergoing thermal coagulation of the Gasserian ganglion is~     very delicate. This is because of the specific operation site and moreover patients should~     recover quickly from anesthesia to follow verbal intraoperative commands of the surgeon.~     Endotracheal intubation or laryngeal mask of course hinders the patient from speaking. An~     obvious alternative airway management, as performed in this preliminary study, is a~     nasopharyngeal placed tube.~      The purpose of the present study is to objectify the gas exchange in patients during this new~     ventilation technique.~   "
120476|NCT01990586|"~     Objective:~      Primary objective of the present study was to compare the single dose bioavailability of~     Torrent's Rabeprazole Sodium Delayed Release Tablets 20 mg and Aciphex® Delayed Release~     Tablets 20 mg (Reference, Eisai Inc., USA). Dosing periods were separated by a washout period~     during fed study.~      Study Design:~      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence~     Study~   "
120477|NCT01990573|"~     Three arm randomized controlled trial to evaluate the efficacy of a single dose of~     intraoperative methadone in reducing post-operative pain and opioid consumption in~     adolescents undergoing posterior spinal fusion. Our secondary goal is to determine the~     pharmacokinetics of IV methadone in children (0.4 and 0.5 mg/kg).~   "
120478|NCT01990560|"~     The purpose of this study is to determine whether mifepristone is an effective treatment for~     hyperglycemia due to mild hypercortisolism.~        -  To test the hypothesis that GR blockade with mifepristone will decrease the severity of~          metabolic syndrome features as measured by waist circumference, lipid profile, body mass~          index, blood pressure and insulin resistance, measured by HOMA-IR score.~        -  To test the hypothesis that GR blockade with mifepristone will improve QoL, depression~          and anxiety scores, measured by validated assessments, in patients with mild~          hypercortisolism.~   "
120479|NCT01990547|"~     The main purpose of this study is to determine whether functional magnetic resonance imaging~     (fMRI), can distinguish between service members with and without traumatic brain injury~     (TBI), as well as those with posttraumatic stress disorder (PTSD) who receive either virtual~     reality exposure therapy (VRET) or PTSD treatment other than exposure therapy. The~     investigators and other investigators have previously identified changes in function in~     multiple regions of the brain in combat veterans with PTSD, and the investigators have also~     seen that structural changes in the white matter associated with combat TBI are also linked~     with changes in function, and in turn with PTSD symptoms. However, the investigators need to~     confirm these findings in larger numbers, and also need to discern whether fMRI can~     distinguish if there is something significantly different about those who have PTSD after TBI~     vs. those in whom it does not follow a TBI. Finally, the investigators have previously~     demonstrated that exposure therapy ameliorates the functional changes in the brain induced by~     PTSD, but the investigators do not know if similar changes occur with other forms of therapy,~     so the investigators seek to compare the two directly. It is our expectation that the~     findings will better inform the choice of therapy for service members with combat-related~     PTSD, with or without TBI.~   "
120480|NCT01990534|"~     This phase 4, single-arm, open-label, multicenter study is designed to evaluate the efficacy~     and safety of brentuximab vedotin as a single agent in adult participants with histologically~     confirmed CD30+ relapsed or refractory classical Hodgkin Lymphoma who have not received a~     prior stem cell transplantation (SCT) and are considered to be not suitable for SCT or~     multiagent chemotherapy at the time of study entry.~   "
120481|NCT01990521|"~     Men with a BRCA1 or BRCA2 mutation are at increased risk for early onset, aggressive prostate~     cancer compared to men in the general population.~      Standard of care screening for men with a BRCA mutation includes PSA testing and digital~     rectal examination (DRE), the same as with men in the general population.~      This study is being done to assess whether there is value in using MRI as a screening tool to~     detect prostate cancer at an earlier stage than may otherwise be detected using standard of~     care screening (PSA, DRE). It is unclear whether MRI has utility as a screening tool in this~     specific population at high risk for aggressive disease.~   "
120482|NCT01990508|"~     Approximately 15% of the US population is enrolled in the Supplemental Nutrition Assistance~     Program (SNAP), and 50% are children. Although the goal is to improve nutritional health,~     preliminary data suggest that enrollment in SNAP is associated with obesity and metabolic~     risks and that SNAP reimburses $4 billion annually for sugar-sweetened beverages (SSBs). This~     pilot project tests an innovative strategy to reduce purchase of non-nutritive, SSBs by~     low-income families with children by combining targeted point-of-purchase education with a~     randomized trial of financial incentives to discourage purchase of unhealthy beverages. The~     study will take place at a mid-size grocery store that is located in a low-income, Latino~     community and where 30% of purchases are made with SNAP. Targeted beverage education will be~     provided to all study subjects with a traffic-light system to identify healthy and unhealthy~     beverages at the point-of-purchase. Individual beverage purchases will be tracked by~     electronically stored cash register sales. Supplementary validation of beverage consumption~     will be assessed by 24 hour dietary recall. Aim 1 is to conduct a randomized controlled trial~     to compare purchase and consumption of SSBs by families assigned to a financial incentive to~     reduce purchase of SSBs with families assigned to control (no incentives). Aim 2 is to~     compare the purchase of SSBs by families in both arms during the study period when they are~     exposed to the traffic-light system to a baseline period prior to traffic-light education.~     Results of this project will provide pilot data for larger scale interventions to promote~     healthy choices among low-income families.~   "
120483|NCT01990495|"~     The majority of individuals with advanced ESRD have reduced exercise capacity in part due to~     decreased muscle mass. This leads to a reduced ability to perform daily activities, a greater~     incidence of falls, and a reduced quality of life. The mechanisms responsible for the loss of~     muscle mass in ESRD are not understood very well. This study is designed to determine the~     effectiveness of an exercise program on improving muscle mass, exercise capacity and quality~     of life in persons with ESRD. In addition, the study will attempt to better understand why~     muscle loss occurs in people with ESRD, the influence exercise has on these mechanisms, and~     whether the response to exercise can be enhanced with nutrient supplementation.~   "
120484|NCT01990482|"~     A delay in the return of normal bowel function with the passage of flatus and feces is one of~     the most important factors affecting early recovery and discharge in patients undergoing open~     complete staging surgery for gynecological malignancies. A prolonged hospital stay increases~     the risk of hospital-acquired infections, deep vein thrombosis, pulmonary compromise and~     total hospital costs.~      The aim of this study was to assess the effectiveness of coffee intake on postoperative bowel~     function in patients undergoing abdominal complete staging surgery for gynecological~     malignancies.~   "
120485|NCT01990469|"~     After a screening, a 2-week, single-blind placebo run-in, 174 patients will be randomized in~     a 1 : 1 ratio to the addition of either once-daily Gemigliptin 50 mg or placebo to ongoing~     stable doses of glimepiride in combination with metformin for 24 weeks.~   "
120486|NCT01990456|"~     Due to lack of studies on mechanical ventilation strategies in patients with severe Acute~     Respiratory Distress Syndrome (ARDS) supported with Veno-Venous Extra-Corporeal Membrane~     Oxygenation (VV ECMO), ventilator settings in this patient population are set arbitrarily.~      In this two-phases prospective, interventional, pilot study we hope to gain physiologically~     relevant data on two aspects of mechanical ventilation in patients with severe ARDS supported~     with VV ECMO: (1) the use of tidal ventilation and (2) the level of Positive End-Expiratory~     Pressure (PEEP).~        1. PHASE 1: impact of tidal ventilation on VILI (10 patients) We hypothesized that a CPAP~          strategy that minimizes end-tidal pulmonary stress and strain mitigates VILI compared to~          the current mechanical ventilation practice that employs tidal ventilation in patients~          with severe ARDS on ECMO.~           In this first phase we will test whether administering a distending inspiratory pressure~          to produce tidal ventilation is superior to a strategy where only continuous positive~          airway pressure (CPAP) is applied for ventilation induced lung injury (VILI) mitigation,~          as assessed by its impact on biotrauma (serum cytokines) and physiologic measurements.~        2. PHASE 2: impact of PEEP on VILI (10 patients) We also hypothesized that adjusting PEEP~          to maximize respiratory system compliance reduces VILI in patients with severe ARDS on~          ECMO.~      In the second phase we will therefore gain more insight as to whether a strategy that~     utilizes a PEEP level that correspond to best compliance is beneficial over Zero~     End-Expiratory Pressure (ZEEP). We will test the impact of both strategies on biotrauma~     (serum cytokines), physiologic parameters, and right ventricular function (transesophageal~     echocardiographic assessment).~      Because ARDS patients supported with VV ECMO can be hemodynamically unstable, the use of~     imaging techniques that require transport, such as computed tomography, is limited.~     Therefore, bedside imaging techniques, such as pleural and lung ultrasound (PLUS) and focused~     bedside cardiac ultrasonography, are important tools for clinicians who care for these~     patients. This study will allow us to learn whether these techniques are feasible and valid~     in this patient population.~      Furthermore, the knowledge gained from this study will allow us to assess the rationale and~     feasibility of performing a similar larger, randomized study in the future.~   "
120487|NCT01990443|"~     The primary objective of this study is to assess the absolute bioavailability of reslizumab~     following administration of a single subcutaneous (sc) dose to healthy non-Japanese~     participants~   "
120488|NCT01990430|"~     Exercise training has been established as a feasible and safe intervention during or after~     neoplastic treatment in breast cancer patients. Numerous studies have shown that exercise can~     prevent and control various treatment-related side effects including functional limitation,~     physical capacity, anxiety and sleep disturbance. In the long-term, an active life style has~     been demonstrated to increase survival in women, who maintain a moderate level of exercise~     per week (30 or 75 minutes of brisk walking 5 days per week).~      Specifically, active breast cancer survivors have a 51-85% lower cancer specific mortality~     and 33-82% lower all cause of mortality. But despite this, most breast cancer patients reduce~     their physical activity levels during and after cancer treatment. In 2010, a roundtable~     meeting of American College of Sport Medicine published guidelines for cancer survivors,~     defining that the recommended amount of exercise was 150 minutes per week of aerobic exercise~     of moderate-intensity and 2 or 3 days per week of strength training that included exercise~     for major muscle groups. But only 30-47% of breast cancer survivors follow these exercise~     recommendations.~      In most clinical settings, information by the oncologist to keep physical active is part of~     the recommendation. Yet some breast cancer patients find it difficult to begin or maintain~     the minimal activity levels recommended by the experts. A typical obstacle includes lack of~     directions from experts, which can assure the safety and feasibility of the exercise that~     they perform. Moreover, important personal aspects can have major influence on the exercise~     preference, including certain food choice and dietary intakes, education level or the~     preference of a face-to-face exercise counseling by a professional.~      A cancer diagnosis is recognized as teachable moment, where patients are particularly~     motivated for lifestyle changes. So it is important to approach the patients with adequate~     interventions that consider the different needs in order to get a healthier behavior among~     the breast cancer patients.~      Taking this into account, the hypothesis of this pilot project is that a guided integrated~     group exercise program, which includes an educational program on healthy life style, will~     increase the adherence of breast cancer survivors to exercise and a healthy diet. Therefore~     the aim of this pilot study was to investigate if a comprehensive and specific group exercise~     program, which includes dietary and exercise information, could increase leisure-time~     exercise in women with breast cancer.~   "
120489|NCT01990417|"~     The present study aimed to analyze the influence of passive stretching before and after~     strength training on flexibility of the hamstrings in people who work out~   "
120539|NCT01989767|"~     The hypothesis was that education of rehabilitation officers who were responsible for~     rehabilitation back to work for sick-listed individuals in screening for mental disorders and~     psychiatric topics would increase the rate of return to work and reduce the number of~     sicklisted days~   "
120490|NCT01990404|"~     Pain in the elderly is poorly evaluated and clearly under treated. Premixed nitrous oxide and~     oxygen is used in the emergency medical care of the trauma, burns, during transport of~     patient with pain. None randomized study has validated the use of premixed nitrous oxide and~     oxygen in the emergency department in the elderly. The aim of the study is to demonstrate the~     efficacy of premixed nitrous oxide and oxygen compared to medical air in elderly patient with~     out-of-hospital severe acute pain~   "
120491|NCT01990391|"~     The purpose this research is to check the effect of Brazil Nuts consumption in oxidative~     stress, metabolic abnormalities and microvascular endothelial function dyslipidemic and~     hypertensive patients.~   "
120492|NCT01990378|"~     Objective:~      Primary objective of the present study was to compare the single dose bioavailability of~     Torrent's Rabeprazole Sodium Delayed Release Tablets 20 mg and Aciphex® Delayed Release~     Tablets 20 mg (Reference, Eisai Inc., USA). Dosing periods were separated by a washout period~     during fasted study.~      Study Design:~      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence~     Study~   "
120493|NCT01990365|"~     Many patients with acute osteoporotic vertebral fracture (acute OVFs) admitted because of low~     back pain. But there are only part of patients with acute OVFs, because some patients do not~     have low back pain although OVFs occurred.~   "
120494|NCT01990352|"~     Primary Objective: To evaluate if low BRCA1 protein expression has a preferential effect on~     response when metastatic breast cancer patients are treated with DNA damaging chemotherapy~     agent, compared to historical controls~      Secondary Objective: To evaluate if low BRCA1 protein expression has a preferential effect on~     tumor progression when metastatic breast cancer patients are treated with DNA damaging~     chemotherapy agent, compared to historical controls~   "
120495|NCT01990339|"~     To evaluate the efficacy of 4-week lansoprazole (Takepron) therapy for subjective symptomatic~     improvement in gastroesophageal reflux disease patients with dyspepsia symptoms~   "
120496|NCT01990326|"~     This study will test the effects of XAF5 Gel (applied to skin each night for 6 weeks) on~     excess submental fat, also known as double chin. The study will also assess the safety and~     tolerability of XAF5 Gel.~   "
120497|NCT01990313|"~     The purpose of this study is to provide objective measurements of abnormal movements of the~     body in correlation with neural activity of the brain and track how these change over time.~     This may allow for the development of objective evaluation of the neural activity causing~     abnormal movements, which may lead to the ability of the DBS system to stimulate the brain by~     sensing the abnormal neural activity that is causing abnormal movements.~   "
120498|NCT01990300|"~     The purpose of this study is to examine the safety and efficacy of long-term use of~     alogliptin/pioglitazone(Liovel) combination tablets in patients with type 2 diabetes mellitus~     determined as warranting combination therapy with alogliptin benzoate and pioglitazone~     hydrochloride~   "
120499|NCT01990287|"~     The purpose of the study is to demonstrate safety and efficacy of spinal cord stimulation~     with peripheral nerve field stimulation for the treatment of chronic low back and leg pain.~   "
120500|NCT01990274|"~     The purpose of this study is to compare two different methods of intensified tuberculosis~     (TB) case finding in the community. These methods all involve the use of a mobile clinic to~     reach people with TB symptoms who are not able to readily access clinic services. A standard~     diagnostics package consisting of smear microscopy and culture (with smear result available~     the next day) will be compared with a novel diagnostics package involving point-of-care~     sputum GeneXpert MTB/RIF performed at a mobile or conventional clinic (with same day result),~     sputum culture, and lateral flow urinary lipoarabinomannan (LAM) testing (in HIV +ve subjects~     only). The primary outcome is a comparison between the number of culture +ve subjects on TB~     treatment in each group at the end of two months. A secondary aim is an evaluation of the~     accuracy and feasibility of GeneXpert performed in a mobile clinic. Additional study aims~     include using chest X-rays obtained during the study to develop and validate of an~     computer-aided diagnosis (CAD) software package for TB (together with collaborators in the~     Netherlands), as well as establishing whether LAM is detectable at sub-ELISA concentrations~     in the urine of those with TB.~   "
120501|NCT01990261|"~     This study will evaluate the survival of non-small cell lung cancer (wild-type EGFR)~     participants treated with Tarceva after at least one failed chemotherapy treatment, and the~     impact of prior chemotherapy treatments.~   "
120502|NCT01990248|"~     This multi-center, prospective, observational safety study will evaluate the safety and~     effectiveness of Zelboraf (vemurafenib) in a real world setting. Data from Zelboraf-treated~     patients with BRAF-V600 mutation-positive unresectable or metastatic melanoma will be~     collected for 2 years.~   "
120503|NCT01990235|"~     The objective of this proposal is to test whether a multi-media website~     (www.prepareforyourcare.org) that is focused on preparing older adults for communication and~     medical decision making can help people engage in advance care planning.~   "
120504|NCT01990222|"~     The goal of this study is to develop and test a mobile web application to optimize early~     stimulant medication treatment for children receiving care for Attention/Deficit~     Hyperactivity Disorder (ADHD) in a publicly-funded mental health clinic.~   "
120505|NCT01990209|"~     The androgen receptor (AR) is expressed in 70-90 percent of primary breast tumors and in 75~     percent of breast metastases. There is evidence to suggest that Androgen Receptor (AR) may be~     a target in patients with advanced breast cancer. Breast cancer patients whose tumors do not~     express the ER, PR or HER2 (triple negative) have very few options for treatment. Orteronel~     is being developed as an endocrine therapy for relevant hormone-sensitive cancers such as~     prostrate cancer and breast cancer. Triple-negative metastatic breast cancer patients with AR~     expression could potentially benefit from anti-androgen therapy like orteronel.~   "
120506|NCT01990196|"~     Prostate cancer is the most common cancer in men and the second leading cause of cancer death~     in men. The purpose of this research study is to compare prostate cancers treated with~     hormone therapy versus prostate cancers treated with hormone therapy plus drugs that directly~     target cancer cells.~   "
120540|NCT01989754|"~     The purpose of this study is to assess the effect of canagliflozin compared to placebo on~     progression of albuminuria in participants with Type 2 Diabetes Mellitus receiving standard~     care but with inadequate glycemic control and at elevated risk of cardiovascular events.~   "
120507|NCT01990183|"~     Stroke and other neurological conditions affect the population of infants in percentages that~     cannot be considered marginal. Preterm infants are the highest infants at risk for~     neurological damage. Currently, infants have rehabilitation sessions few times a week in~     rehabilitation centres but according to basic neuroscience it would be necessary to provide~     them with an early, intensive and multiaxial intervention. One option to reduce the cost of~     the entire European Healthcare System while increasing the practice of rehabilitation is to~     devise therapies and technologies that can be administered at home by caregivers and~     telemonitored by rehabilitation staff. The aim of this proposal is to promote early~     intervention in the first year of life and to reinforce therapy by CareToy: a portable low~     cost smart system telemonitored thus augmenting the clinical effectiveness of the therapy~     while reducing the cost. The smart system is based on a common baby gym, composed of~     different modules: a) an instrumented baby gym with mechatronic hanging toys, so that the~     infants' actions on the gym can be measured and stimulated, b) a vision module, for measuring~     and promoting infants' attention and gaze movements and c) a sensorized mat for measuring and~     promoting postural control. Each module will also incorporate built-in signal processor,~     memory and wireless communication. A fourth telerehabilitation module completes the system~     that allows the system to remotely communicate with the rehabilitation staff for monitoring~     and assessing the rehabilitation techniques. CareToy and the effectiveness of home~     rehabilitation based on this system will be validated by clinical trials on at least 50~     preterm infants. The result of this project could have a large impact. CareToy may become a~     commercial product, manufactured on a large scale and distributed not only in rehabilitation~     centres but also at homes, sold or rented by the Health Care System to families as a~     therapeutic tool for care intensity.~   "
120508|NCT01990170|"~     The purpose of this study is to determine long term healing rates of chronic venous ulcers~     (CVU) after ultrasound-guided foam sclerotherapy (UGFS) of superficial venous reflux (SVR)~     and to relate recurrence of CVU to evidence of recanalisation and the presence of superficial~     or deep venous reflux~   "
120509|NCT01990157|"~     This study is in two stages:~      Stage 1 purpose is to assess safety, tolerability, and efficacy of multiple TAB08 doses in~     patients with active Rheumatoid Arthritis in which methotrexate (MTX) treatment is not enough~     effective.~      Stage 2 purpose is to assess efficacy parameters (ACR criteria) of at least one selected~     TAB08 dose in extended patient population with active Rheumatoid Arthritis in which~     methotrexate (MTX) treatment with at least 10 mg/week is not enough effective.~   "
120510|NCT01990144|"~     The purpose of the study is to evaluate feasibility and efficacy of rituximab-bendamustine~     (R-B)combination in elderly patients affected by diffuse large B-cell lymphoma and defined as~     frail according to CGA.~   "
120511|NCT01990131|"~     The purpose of this study is to test the effectiveness and usability of multiple~     computer-based treatments for mood and anxiety relevant risk factors. The target of the~     treatment is related to cognitive stress, which has been shown to be associated with a~     variety of negative mental health outcomes such as Post-Traumatic Stress Disorder, suicidal~     ideation, and substance use disorders.~   "
120512|NCT01990118|"~     The purpose of this study is to establish the therapeutic equivalence of Gengraf® with the~     standard treatment Neoral® for a treatment period of 6 months in stable renal allograft~     transplant recipients with respect to drug levels, dosage, and acute graft rejection and~     other adverse events.~   "
120513|NCT01990105|"~     FINFIB 2 is an observational investigator-driven study that seeks to examine current~     treatment practice for atrial fibrillation in Finland. The investigators hypothesis is that~     the treatment of atrial fibrillation has improved since the introduction of new~     antiarrhythmic drugs and anticoagulants.~   "
120514|NCT01990092|"~     The objectives of the MEDIAN study are to evaluate the short-term and long-term safety and~     nutritional benefits of Metanx® versus placebo in subjects with mild to moderate diabetic~     peripheral neuropathy (DPN). Short-term effects will be evaluated during the first 16 weeks~     of treatment, and long-term effects will be evaluated over the duration of a 48 week~     treatment period.~   "
120515|NCT01990079|"~     The primary goal of the study is to evaluate the use of a new smart phone application in~     preventing relapse to smoking among people with PTSD. The technology intervention will~     combine a mobile system to reward non-smoking, smoking cessation counseling, smoking~     cessation medications, and use of the smart phone app. The primary aim is to evaluate how~     effective this intervention is in preventing smoking relapse compared to another intervention~     that does not include the app.~   "
120516|NCT01990066|"~     Implementation of a home based exercise program to reduce functional decline, cancer related~     fatigue (CRF) and improve quality of life in the elderly gynecologic oncology patient~      Problem:~      Can prevention of CRF and loss of function improve QOL in the elderly gynecologic oncology~     patient undergoing chemotherapy?~      Support:~      Fatigue and its impact on QOL is a major concern with the elderly patient receiving~     chemotherapy. When compared to younger adults QOL is more important than gain in survival for~     elderly patients. (Eyigor, et al., 2010).~      The National Comprehensive Cancer Network recommends exercise as the most effective~     intervention for cancer related fatigue.~      Methods:~      This is a single institution randomized controlled study to evaluate a home based exercise~     program in elderly gynecologic oncology patients undergoing chemotherapy. Subjects will be~     randomized to the intervention group or to the control group receiving usual care.~      Intervention group will receive a home exercise program 3 days weekly consisting of 30mins of~     strength and aerobic activity, utilizing a follow along exercise DVD and patient log to~     assist with compliance.~      The two groups will be compared by 1) objective PT assessment with the Berg Balance and 6~     minute walk test (before or after) Cycle 1 and 6, 2) subjective nursing assessment with the~     NHANES (National Health and Nutrition Examination Survey) and FACIT- F (Functional Assessment~     of Chronic Illness Therapy: Fatigue) prior to Cycle 1 (baseline),4 (midpoint), and following~     cycle 6 (completion).~      Conclusion:~      PT directed home exercise program may improve CRF, functional decline, and QOL in elderly~     gynecologic oncology patients undergoing chemotherapy.~   "
120517|NCT01990053|"~     Standard treatments for depression in specialty care settings are effective but resources for~     delivering empirically supported psychotherapies are often limited. Computerized cognitive~     behavioral therapy (cCBT) is an effective and highly scalable treatment for depression that~     might help expand services in psychiatric settings, however, little is known about its~     efficacy in this population. The present study aims to establish the efficacy of a~     internet-delivered cCBT program (Beating the Blues) plus email and telephone support for~     depression in a psychiatric outpatient clinic setting. The secondary aim is to pilot an~     assessment procedure designed to identify moderators of treatment effectiveness.~   "
120518|NCT01990040|"~     This is a global prospective, observational, multi-center registry to evaluate the long-term~     safety profile for patients with short bowel syndrome (SBS) who are treated with teduglutide~     in a routine clinical setting. The registry will also evaluate the long-term clinical~     outcomes in patients with SBS. SBS patients treated and not treated with teduglutide will be~     enrolled.~   "
120520|NCT01990014|"~     The objective of this protocol is to evaluate the quality of life and functional disability~     in the long term (2 years after craniectomy) in subject's victims of malignant Sylvien stroke~     who received a decompressive craniotomy in the acute phase. Patients who have given their~     consent to be evaluated at least two years after their stroke and their operation in a single~     visit by clinical examination and procurement of standardized scales. Will be measured the~     quality of life through scale SIS3.0, residual disability by the Rankin scale. The quality of~     life of the carer will be assessed through scales and Zarit carer version of SIS3.0. The~     existence of predictive parameters of long-term evolution will be searched in determining the~     existence of a correlation between demographic data and baseline characteristics of the~     stroke on and the evolution of the quality of life.~   "
120521|NCT01990001|"~     The broad objective of this research is to determine whether a quick, simple intervention~     will increase utilization of contraceptive reminders and adherence to short‐term~     contraceptive regimens. Such an intervention could be implemented easily with no additional~     resources into a busy clinical practice.~   "
120522|NCT01989988|"~     The investigators would like to conduct a randomized clinical trial to compare the efficacy~     of diabetes treatment between different gastric bypass procedures involving type 2 diabetics~     patients with BMI from 27.5 to 35 kg/m2~   "
120523|NCT01989975|"~     The purpose of this study is to evaluate the performance, patient satisfaction and safety of~     connectivity gateway device CareLink Connect, transferring CGM data from a VEO insulin pump~     to CareLink online (every 5th minute) and thereby making it available for patients or Care~     Partners individual web connected devices such as smartphones, tablets and PCs.~   "
120524|NCT01989962|"~     Education for Equity (E4E)intervention intends to improve care delivery through a well~     designed educational program that address not only the issues of diabetes care delivery to~     Aboriginal patients with diabetes, but also the issues of effective cross-cultural and~     culturally safe communication between healthcare providers and Aboriginal patients, and the~     issues related to effective implementation of appropriate chronic disease management programs~     for Aboriginal patients in a range of practice settings. The purpose of this study is to~     evaluate the effectiveness of the E4E education program through measuring patient clinical~     outcomes, patient experience with their doctors, and the changes in physicians' approaches to~     care perceived by Aboriginal diabetic patients.~   "
120525|NCT01989949|"~     This is a phase 1, open-label, randomized pharmacokinetic and safety study in healthy adult~     subjects, who will undergo bronchoscopy and bronchoalveolar lavage (BAL) after receiving~     seven (7) doses of 1.0 mg/kg IV TP-434.~   "
120526|NCT01989936|"~     To determine the tolerability and efficacy of eletriptan in patients who had discontinued~     oral sumatriptan due to lack of efficacy or intolerable adverse events (AEs) during previous~     clinical treatment (not a controlled trial).~   "
120527|NCT01989923|"~     This feasibility study will compare two smoking cessation methods, traditional nicotine~     replacement therapy and Electronic Nicotine Delivery Systems (electronic cigarettes) in~     patients with gynecological conditions.~   "
120528|NCT01989910|"~     A pilot study to compare the efficacy and safety of raltegravir-based versus efavirenz-based~     combination therapy in treatment-naïve patients with HIV-1 infection.~   "
120529|NCT01989897|"~     This is a double-blind study with respect to the diluents used, with patients known to be~     allergic to the specific allergen tested. Three study sites will be involved, each testing~     one allergen (Cat, Mite, Timothy grass pollen). Subjects who are known to be allergic to the~     allergen in question will be tested with serial three-fold dilutions to determine the ID 50~     and relative extract potency using the method described by Turkeltaub.~   "
120530|NCT01989884|"~     Italian Study On The Efficacy Of Ortataxel In Recurrent Glioblastoma~   "
120531|NCT01989871|"~     The authors hypothesize that adjusted individual feeding (AIF) for preterm infant starting~     from transition to oral feeding (33 weeks corrected age) will result in less episodes of~     apnea/bradycardia, early achievement of full oral feeding, improved weight gain and shorten~     hospitalization duration in the short term.~      In the long term AIF will result in higher scores on the Griffith's developmental scales,~     decreasing parental anxiety and feeding disorders .~   "
120532|NCT01989858|"~     The study addresses two primary questions, according to its factorial design:~        -  to compare the efficacy in terms of overall survival (OS) of a peri-operative vs. a~          post-operative chemotherapy (CHT) treatment, irrespectively of the presence of a~          post-surgical chemo-radiotherapy (CHT-RTX) (Timing Study);~        -  to compare the efficacy in terms of relapse free survival (l-RFS) of a post-surgical~          CHT-RTX treatment vs. no other treatment, irrespectively of the timing of CHT (RTX~          Study).~      The study has a 2x2 factorial design, thus consisting of two independent, following specific~     eligibility criteria and with different randomization scheme studies, the Timing Study and~     the RTX Study.~      Both studies are Italian, multicentre, open-label, randomized, superiority, phase III trials~     conducted in patients with histologically confirmed, localized gastric adenocarcinoma, which~     is considered operable.~      In the Timing Study patients fulfilling the eligibility criteria will be randomized with a~     1:1 ratio to receive:~        -  peri-operative CHT (Arm A) or~        -  post-operative CHT (Arm B) Once randomized in the Timing Study, patients may also be~          randomized in the RTX~      Study to receive in addition to CHT a post-operative CHT-RTX treatment or no other treatment.~     This is possible since the randomization will be done in two steps: the first for the Timing~     Study for all the participating centres (peri-operative CHT vs. post-operative CHT) and the~     second one for the RTX Study, only for those centres with the radiotherapist willing and able~     to participate (post- surgical CHT-RTX vs. no other treatment). Thus the following four arms~     will be generated:~        -  peri-operative CHT (Arm A)~        -  post-operative CHT (Arm B)~        -  peri-operative CHT + post-operative CHT-RTX (Arm C)~        -  post-operative CHT + post-operative CHT-RTX (Arm D) The study will be conducted in more~          than one hundred experimental centres. Follow-up F(-up) procedures and timing of the~          visits will be consistent with current clinical practice.~      Based on case-mix of sample 1000-1180 patients are needed in the Timing study and 420-520 in~     the RTX study.~   "
120541|NCT01989741|"~     -  hypothesis: sleep restriction in healthy subject trigger alteration of decision making~          associated with immuno-inflammatory changes~        -  inclusion criterias: healthy subjects, men, under 35 years, BMI<26, no sleep troubles,~          intermediate chronotype~        -  design: 12 subjects, longitudinal study 2 days of baseline, 7 night of sleep restriction~          (4h sleep/night), recovery (1, 2, 3 and 9 normal sleep nights).~        -  parameters: decision making tests, reaction time, wakefulness test, biological~          parameters (cathecholamines, pro-inflammatory cytokines...), heart rate, blood pressure~        -  control of sleep restriction: continuous polysomnographic survey~   "
120542|NCT01989728|"~     The hypothesis was that a large fraction of individuals with common mental disorders were~     undetected in long-term sickness and that detection of the disorders by screening, a~     psychiatric diagnostic examination and feedback to the individuals, primary care, and~     rehabilitation officers improved return to work, improved quality of life and reduced~     psychological distress.~   "
120533|NCT01989845|"~     Rivaroxaban has been developed in the various clinical settings, prevention of venous~     thromboembolism (VTE)after major orthopedic surgery, prevention of stroke in atrial~     fibrillation, and in the treatment of acute coronary syndromes. And, in the~     EINSTEIN-pulmonary embolism (PE) and EINSTEIN-deep venous thrombosis (DVT) programs,~     rivaroxaban showed non-inferior to standard therapy for the treatment of PE and DVT. However,~     there has been limited experience of rivaroxaban with secondary VTE prophylaxis in cancer~     patients. Although cancer-associated DVT or PE was included in previously mentioned EINSTEIN~     programs, only approximately 5% of the total populations were cancer patients in these~     studies. Thus, investigators could not automatically translate the results of these studies~     into the real practice management of cancer-associated VTE patients. Moreover, until now, new~     oral anticoagulants, including dabigatran and rivaroxaban, have been compared to long-term~     warfarin therapy, which were well-known inferior agent, but not low molecular weight heparin.~     In this sense, investigators feel that new oral anticoagulants, particularly rivaroxaban,~     should be re-investigated in this highly specific patients group. Therefore, investigators~     are planning to conduct a prospective study evaluating the efficacy and safety of rivaroxaban~     in Korean patients with cancer-associated VTE.~   "
120534|NCT01989832|"~     The prevalence of renal acute rejection in transplantation is reduced thanks to the optimized~     use of immunosuppressive drugs. However, graft survival at ten years has not improved since~     then; this may be explained in part by the toxicity of these drugs, viral infections, and~     other comorbidities (diabetes, cardiovascular diseases …).~      According to transplant center, strategies for the combination of immunosuppressive drugs are~     different, and probably involve a difference in the global cost of patient management. There~     is no recommendation in France to establish similar practices.~      EPHEGREN is an observational, prospective, multicentric, pharmacoeconomic study for the renal~     transplant patients.~   "
120535|NCT01989819|"~     Primary Sjögren syndrome (pSS) is an inflammatory, autoimmune, multiorgan disease often~     involving the central and peripheral nervous systems. Fifteen to twenty percent of patients~     with the primary Sjögren's syndrome have neurological complications involving the peripheral~     nervous system. Although some patients have large fiber neuropathy, around forty percent of~     patients with Sjögren's syndrome experience neuropathic pain with normal electrodiagnostic~     studies. Although these patients may be diagnosed with fibromyalgia or depressive symptoms,~     some have been shown to have small fiber neuropathy (SFN). A recent study proved that more~     than 90% of pSS patients with such neuropathic pain have SFN {Fauchais, 2010 #188}.~      The aim of this study will be to investigate the occurrence of small fiber neuropathy in~     patients with pSS and neuropathic pain with normal electromyographic studies and to determine~     the existence of a conjoint local inflammatory process mediated by cellular, cytokinic or~     auto-antibody response. Quantification of epidermal nerve fiber density after skin biopsy is~     a valuable tool to diagnose small fiber neuropathy and the method has been widely validated.~     A skin biopsy will be performed in patients and control and will allow quantification of~     small fiber density in skin sample along with measurement of sweat gland innervation.~     Moreover, pathophysiological studies will be carried on in order to evaluate the causal~     relationship between cellular and humoral inflammation and small fiberneuropathy.~      Recent studies have pointed out the inconstant efficacy of both corticosteroid and~     immunosuppressive drugs in pSS-related SFN. Dissecting the molecular mechanisms of small~     fiber neuropathy in these patients may help designing new therapeutic strategies.~   "
120536|NCT01989806|"~     Evidences showed that patients suffering from spinal cord injury (SCI) have poor mobility and~     higher chance to develop cardiopulmonary diseases, which leads to poor quality of life and~     shorter life expectancy. Different modalities were developed aiming at mobility restoration~     in SCI patients and robotic assisted body weight supported treadmill training is one of the~     latest technique in recent years. Yet there are scarce studies to investigate its~     effectiveness. The purpose of this study is to investigate the effectiveness of~     robotic-assisted body weight supported treadmill training on mobility and cardiopulmonary~     function of patients suffering from SCI by a randomized controlled trial.~      80 patients suffering from incomplete SCI will be recruited for an 8-week training program.~     They will be randomized into either robotic assisted body weight supported treadmill training~     group or passive lower limb mobilization training group. The training effects will be~     measured by Walking Index for Spinal Cord Injury version II, lower extremity motor score,~     lower limb Modified Ashworth Scale, robotic gait system, gait analysis and gas analysis under~     sub maximal exercise stress test.~      Through the study, we intent to find the effectiveness of robotic-assisted body weight~     support treadmill training on walking and cardiopulmonary recovery with patients suffering~     from incomplete spinal cord injury.~      The hypothesis of the study is:~      Compared to the control group, robotic-assisted body weight supported treadmill training~     leads to a greater improvement in walking ability and cardiopulmonary functioning.~   "
120537|NCT01989793|"~     This research study is being done to see whether losartan can prevent the decrease in~     strength associated with aging.~      Muscle loss is associated with aging and has multiple symptoms such as weakness, slowness,~     and fatigue (tiredness). Older adults with muscle weakness have a higher risk of falls and~     disability. In addition, the loss of independence for older adults can lead to a poorer~     quality of life.~      Recently, it was discovered that losartan, a medication commonly used to treat high blood~     pressure, had slowed the strength decline seen in older mice. In addition, it allowed injured~     mice skeletal muscle to heal faster. Therefore, we would like to see if losartan can do the~     same for older adults.~      Losartan is approved by the Food and Drug Administration (FDA) for the treatment of high~     blood pressure, heart failure, and to protect the kidneys in diabetic patients. Losartan is~     not FDA-approved to prevent the decrease in strength associated with aging.~      In this study, participants age 70 and older will be asked to take losartan or a placebo to~     see if losartan can help prevent loss of muscle strength. A placebo is a substance that looks~     like the study drug but that contains no active ingredients.~   "
120538|NCT01989780|"~     To evaluate optimal usage of bevacizumab to compare which is better, continuing bevacizumab~     and paclitaxel or switching to hormonal maintenance therapy followed by~     bevacizumab+paclitaxel after induction therapy of bevacizumab+paclitaxel.~      To examine biomarkers such as monitoring markers of study treatment as exploratory analysis.~   "
141951|NCT01709240|"~     The purpose of this study is to assess the safety and performance of the BioWeld1 System~     procedure for surgical incision closure of the skin in women scheduled for elective C-section~     procedure.~   "
120543|NCT01989715|"~     Postural balance on both feet, characteristic of the human species, is possible by the~     tension of muscle of the whole body from toes to head.~      Body position depends on many inputs such as vision, vestibule, skin receptors, states of~     muscle tension receptors. Information is integrated in a complex nervous system via the~     ascending and descending pathways. The information is then analyzed to provide feedback on~     body position. Any variation of body position, induces a variation of the center of pressure.~     Impaired body positioncan cause pain (back pain, neck pain) or long-term deformation~     (including scoliosis or kyphosis).~      Maxillas position, via the activity of masseter and temporal muscles, acts on the muscle~     chain that controls posture. Incorrect positioning of the jaw in the three directions of~     space seems to create an asymmetric masticatory muscles activity and thus destabilize the~     muscle chain responsible for body position. Repositioning maxillas by orthognathic surgery~     could alter the body posture via changing the activity of the masticatory muscles.~      However, nowadays no clear link has been demonstrated between maxillas repositioning and body~     posture modification.~      The purpose of this study is to highlight the link between posture and jaws position, by~     analyzing the variation of the masticatory muscles activity and, the changes in body center~     of pressure before and after orthognathic surgery of jaws standardization.~      In this study each patient will be evaluated in terms of occlusion and body posture before~     surgery and after surgery (2 months) by the same protocol. The surgery will be performed in~     the Maxillofacial Surgery service - Pr BLANC and assessment will take place in the dentistry~     department - Prof. Salvadori La Timone Hospital, Marseille.~      The assessment includes the body posture study with a stabilometric platform (eyes open /~     eyes closed and with / without tooth contact), and analysis of the head orientation relative~     to the vertical. Electromyographic muscle masseter assessment (jaw with/without contact ) are~     devoted to check the evolution of the developed forces, and hand strength will be recorded~     using a dynamometer.~      All these data will be recorded for all the patients. Patients will be divided into four~     subgroups: (1) maxillary endognathia, (2) mandibular prognathism , (3) mandibular~     retrognathia and (4 mandible repositioning.~      Statistical analysis is aimed at validating or not the hypothesis of changes in body posture~     caused by surgical maxillas repositioning.~   "
120544|NCT01989702|"~     The aim of the present study was to examine the efficacy of a probiotic-based product on~     either reducing hypertension or preventing a high normal blood pressure from reaching~     hypertensive levels.~   "
120545|NCT01989689|"~     The investigators plan to measure the health of the vascular system of subjects taking~     Etanercept for the treatment of plaque psoriasis.~   "
120546|NCT01989676|"~     The current study will compare the efficacy, safety, pharmacokinetics and immunogenicity of~     PF-05280014 in combination with paclitaxel versus trastuzumab sourced from the European Union~     (trastuzumab-EU) with paclitaxel in female patients with HER2-positive, metastatic breast~     cancer in the first-line treatment setting. The hypothesis to be tested in this study is that~     the efficacy (ORR) of PF-05280014 is similar to trastuzumab-EU.~   "
120547|NCT01989663|"~     This is a Phase I, five arm, single site, randomized, double blind placebo-controlled trial~     assessing the safety of tenofovir vaginal gel and film formulations. HIV negative women will~     be randomized to gel or film, tenofovir or placebo. This study will provide additional~     information in the evaluation of vaginal films containing microbial agents in humans. In~     addition to safety, the efficacy of these formulations against HIV in an ex vivo biopsy~     challenge model will be compared.~      This study is the first study assessing the safety of tenofovir film in humans. Tenofovir~     film is formulated in a cellulose based vaginal film containing hydroxypropyl methyl~     cellulose (HPMC) E5 (5 cp), hydroxyethyl cellulose (HEC), Sodium Carboxymethylcellulose~     (NaCMC), and glycerin. The excipients of the film have documented safety in other clinical~     settings.~      While the tenofovir film has not been studied extensively in preclinical studies, there are~     favorable safety data from the macaque study and a substantial body of research with~     tenofovir gel. It is appropriate to advance the tenofovir film products into a clinical trial~     for the following reasons:~        -  No safety concerns were note in the tenofovir film macaque trial.~        -  The toxicity of tenofovir administered vaginally has been studied extensively. No~          clinically significant toxicity associated with this route of administration has been~          observed to date.~        -  All of the active ingredients of the tenofovir film have been tested in pre-clinical~          toxicity studies; therefore, the influence of these ingredients on the toxicity profile~          of tenofovir has been adequately evaluated and has been shown to result in no local or~          systemic effects.~        -  The individual components of the tenofovir film have been adequately evaluated and have~          been shown to be safe.~   "
120548|NCT01989650|"~     Recent research has suggested that endoscopist fatigue may significantly affect the polyp~     detection rate. There have been no studies on interventions that may reduce endoscopist~     fatigue and therefore improve colonoscopy performance.~      We want to determine whether a break in the middle of colonoscopy session would maintain a~     more stable adenoma detection rate~   "
120549|NCT01989637|"~     It is important to identify and evaluate foods, such as strawberries, that can improve~     established and emerging cardiovascular risk factors, such as postprandial lipid and glycemic~     responses, and vascular health. Postprandial derangements may affect multiple metabolic~     pathways that lead to increased arterial stiffness. Research has demonstrated the potential~     of strawberries to ameliorate postprandial responses to a high fat/high glucose meal. Further~     research is needed to demonstrate this effect in better controlled clinical studies and~     explore whether metabolic effects lead to improved arterial health.~      The investigators propose to examine the effects of adding 40 g of freeze-dried strawberry~     powder to a high fat/high glucose meal on postprandial cardiovascular risk factor including~     lipids, insulin, glucose, and arterial stiffness and central blood pressure. The~     investigators hypothesize that the bioactive components of strawberry powder will attenuate~     postprandial lipemic and glycemic responses, as well as improve measures of arterial health.~   "
120550|NCT01989624|"~     Few data are currently available in the literature on pancreatic adenocarcinoma in France.~     About 8,000 new cases each year in France. The 5-year survival for all stages combined is~     <5%. This is the only digestive cancer in which mortality / incidence ratio is 98%.~      Epidemiological characteristics at diagnosis, the impact on the survival of recent advances~     related to surgery, adjuvant chemotherapy and new standard forms of adjuvant chemotherapy~     (FOLFIRINOX) are mispriced in real life.~      The development of new drugs and the development of Phase II and III require a better~     understanding of the state of this disease in the country.~      The main objective is to describe the characteristics of the pancreatic adenocarcinoma at~     diagnosis in France and make an inventory of diagnostic practices and support.~   "
120551|NCT01989611|"~     A prospective, open, multicenter,demonstrative of PrEP, which aims to assess the~     acceptability, feasibility and safety from chemoprophylaxis co-formulated emtricitabine /~     tenofovir disoproxil fumarate (FTC / TDF) administered orally, once daily, to MSM and~     transgender women . The demonstration project aims to include 400 participants over 12~     months, with 200 at IPEC-Fiocruz, 100 at CRT-SP and 100 at USP.~   "
120552|NCT01989598|"~     This phase II trial studies how well trametinib and Akt inhibitor GSK2141795 work in treating~     patients with multiple myeloma that has come back (relapsed) or that does not respond to~     treatment (refractory). Trametinib and Akt inhibitor GSK2141795 may stop the growth of cancer~     cells by blocking some of the enzymes needed for cell growth.~   "
120553|NCT01989585|"~     This partially randomized phase I/II trial studies the side effects and best dose of~     dabrafenib, trametinib, and navitoclax and to see how well they work in treating patients~     with v-raf murine sarcoma viral oncogene homolog B (BRAF) mutant melanoma or solid tumors~     that have spread to other parts of the body or cannot be removed by surgery. Dabrafenib,~     trametinib, and navitoclax may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~   "
120554|NCT01989572|"~     This randomized phase III trial studies sargramostim (Granulocyte-macrophage~     colony-stimulating factor, GM-CSF) or vaccine therapy alone to see how well they work~     compared to sargramostim and vaccine therapy together in preventing disease recurrence in~     patients with locally advanced or stage IV melanoma that has been removed by surgery.~     Sargramostim may stimulate the immune system in different ways and stop tumor cells from~     growing. Vaccines made from peptides may help the body build an effective immune response to~     kill tumor cells. It is not yet known whether yeast derived sargramostim and vaccine therapy~     are more effective alone or together in preventing recurrence of melanoma.~   "
120555|NCT01989559|"~     This pilot clinical trial studies booster vaccination in preventing disease recurrence in~     previously vaccinated patients with melanoma that has been removed by surgery. Vaccines made~     from peptides may help the body build an effective immune response to kill tumor cells.~     Giving booster vaccinations may make a stronger immune response and prevent or delay the~     recurrence of cancer.~   "
120556|NCT01989546|"~     Background:~        -  The poly (ADP-ribose) polymerase (PARP) family of enzymes is critical for maintaining~          genomic stability by regulating a variety of DNA damage repair mechanisms.~        -  BMN 673 is a PARP inhibitor with greater in vitro activity than any other PARP inhibitor~          currently in development. BMN 673 has been shown to cause single-agent synthetic~          lethality in BRCA1/2- and PTEN-deficient cell lines, and has potent antitumor activity~          in animal models of tumors harboring mutations in DNA repair pathways.~        -  BMN 673 is showing promising single-agent activity in patients with advanced ovarian and~          breast cancer harboring deleterious BRCA mutations.~        -  This pilot study will evaluate the pharmacodynamic effects of BMN 673 on DNA damage and~          apoptosis markers in tumor biopsy tissue.~      Primary Objective:~      -Determine the pharmacodynamic effect of BMN 673 in tumor biopsies from patients with~     advanced ovarian, breast, or other solid tumor and deleterious BRCA mutations.~      Secondary Objectives:~        -  Determine the response rate (CR + PR) of treatment with BMN 673 in patients with~          advanced ovarian or primary peritoneal carcinoma and deleterious BRCA mutations.~        -  Determine the response rate (CR + PR) of treatment with BMN 673 in patients with~          advanced breast carcinoma and deleterious BRCA mutations.~        -  Determine the response rate (CR + PR) of treatment with BMN 673 in patients with~          advanced solid tumor (other than breast or ovarian) and deleterious BRCA mutations.~      Eligibility:~        -  Adult patients with documented deleterious BRCA 1 or 2 mutations with histologically~          confirmed ovarian, primary peritoneal, breast, prostate, pancreas, gastric or other~          solid tumor whose disease has progressed following at least one standard therapy or who~          have no acceptable standard treatment options.~        -  No major surgery, radiation, or chemotherapy within 4 weeks prior to study enrollment,~          and recovered from toxicities of prior therapies to at least eligibility levels.~        -  Age greater than or equal to 18 years of age; ECOG performance status less than equal to~          2~        -  Adequate organ function.~        -  Willingness to undergo tumor biopsies.~      Study Design:~        -  BMN 673 will be administered orally each day in 28-day cycles.~        -  Dosing will be at the established recommended Phase II dose of 1000 mcg/day each day for~           28 days.~        -  We plan to accrue a total of 12 evaluable patients per cohort for a total of 36~          patients. To allow for some patients who will not be evaluable, the accrual ceiling is~          42 patients.~        -  Tumor biopsies will be mandatory at baseline (pre-dose), and then approximately 3-6~          hours post BMN 673 on day 8. An optional tumor biopsy may also be collected at time of~          disease progression.~      SCHEMA~        -  BMN 673 is administered orally each day in 28-day cycles~        -  Tumor biopsies will be performed at baseline (pre-treatment) and 3-6 hrs post dose on~          cycle 1 day 8. An optional tumor biopsy may also be collected at time of disease~          progression. Tumor biopsies will be evaluated for PAR levels, DNA damage response~          markers such as >=H2AX, cleaved caspase 3, ERCC1, pNbs1, XPF, RAD51, and pT1989ATR, and,~          as indicators of ATR/ATM activation, chk1 and chk2~        -  Blood samples for CTC analyses will be collected at baseline (pre-treatment), on cycle 1~          day 1(3-6 hours post dose), on cycle 1 day 8 (3-6 hours post dose), and on cycle 2 day 1~          (3-6 hours post dose)~        -  Blood samples for PK analysis will be collected on cycle 1 day 1 pre-dose and 0.5, 1, 2,~          3, 4, 6,8, and 24 hours post-dose, on cycle 1 day 8 (3-6 hours post dose), and on cycle~          2 day 1 predose and 3-6 hours post dose.~   "
120557|NCT01989533|"~     Background:~      - Vaccines create resistance to disease. This study tests experimental human immunodeficiency~     virus (HIV) vaccines that use an adenovirus as a transporter. Transporters may help vaccines~     stimulate an immune response against HIV. This means the body works to fight infection.~     Researchers want to see if different ways of giving the vaccines cause different immune~     responses. They also want to see if the vaccines adenovirus is contagious. Adenoviruses cause~     cold symptoms or mild eye infections.~      Participants cannot get HIV from these vaccines. But they can get the adenovirus, so their~     entire household and intimate contacts must participate.~      Objective:~      - To test the safety of experimental HIV vaccines.~      Eligibility:~      - Healthy adults 18-49 years old.~      Design:~        -  Participants will be screened with medical history, physical exam, and blood and urine~          tests.~        -  Participants will receive the vaccine 3 times over 6 months. Each time, they will have a~          physical exam and blood and urine tests. Samples will be taken from their nose, rectum,~          and cervix.~        -  Some participants will receive the vaccine by swallowing 11 capsules with water. Clinic~          staff will observe them for 1 hour.~        -  Some participants will receive the vaccine swabbed in their throat. They will get dose 1~          at the hospital and stay there for 1 week. They will have medical tests and nose swabs.~          Doses 2 and 3 will not require a hospital stay.~        -  Participants will have 7 follow-up visits over 6 months, with a physical exam and blood~          tests. Samples will be taken from their nose, throat, and rectum.~        -  Household and intimate contacts will have 4 clinic visits over 8 months, with a physical~          exam and blood tests.~   "
120558|NCT01989520|"~     Study to investigate relative bioavailability of up to five different formulations of AZD5069~   "
120559|NCT01989507|"~     The purpose of this study is to determine the efficacy, acceptability and unintended~     consequences of very low nicotine content cigarettes (VLNCC) in smokers with current or past~     year substance use disorders (SUD). The primary aim of this study is to determine whether 6~     weeks of VLNCC compared to normal nicotine content cigarettes (NNCC) will result in more~     smoking cessation over 6 months and reduce cigarette use, cotinine, and biomarkers of~     toxicity. We will also assess the effects of VLNCC versus NNCC cigarettes on frequency of~     substance use and substance cravings (drugs and alcohol) because this is relevant to the~     safety of these products among smokers with SUD. Secondary aims are to study effects on~     cigarette craving, nicotine withdrawal and dependence, and depressed mood. Methods: Random~     assignment to VLNCC versus NNCC of up to 312 smokers with SUD will be balanced by gender,~     degree of tobacco dependence, and recent drug and alcohol use. All smokers will be provided~     with smoking counseling. Assessments over 6 months will assess effects both during the 6~     weeks of using research cigarettes and after return to usual cigarettes. The importance is in~     determining the viability and safety of this public health strategy in terms of effects on~     both smoking and other substance use in a highly addicted population, which is essential to~     determine before the FDA implements this policy.~   "
120560|NCT01989494|"~     This study will measure and compare the physical activity of the anesthesiologists during~     routine daily work in the operating room as determined by the pedometer-counted steps and to~     estimate the average daily physical activity by using a seven day exercise recall survey.~   "
120561|NCT01989481|"~     The purpose of this observational study is to investigate the preoperative and operative~     factor of pain and functional outcome at one years following total knee arthroplasty and~     spinal surgeon.~   "
120562|NCT01989468|"~     The purpose of this study is to provide 24 - 52 week efficacy, safety and tolerability data,~     as well as up to 3-year efficacy, safety and tolerability data in subjects with active~     Psoriatic Arthritis despite current or previous nonsteroidal anti-inflammatory drug (NSAID),~     disease-modifying antirheumatic drug (DMARD) therapy and/or previous anti-tumor necrosis~     factor alpha (TNFα) therapy.~   "
120563|NCT01989455|"~     Single center, randomized, double-blind, placebo-controlled, adaptive sequential~     ascending-dose study for the evaluation of the safety, tolerability, and pharmacokinetics of~     single doses of deferiprone administered by intravenous infusion to healthy males and~     females. A bioavailability comparison will be included.~   "
120564|NCT01989442|"~     The study aims to investigate efficacy and safety of nasal mask and prongs used in~     non-invasive ventilation in newborns by using esophageal pressure transducer.~      The parameters including ventilation duration, hospitalization duration, pulmonary outcomes~     and side effects will be evaluated.~   "
120565|NCT01989429|"~     M5181 - a novel vitamin D3 analogue - is currently under development for the treatment of~     plaque psoriasis and is being developed as a topical ointment formulation (M518101)~      Clinical and non-clinical studies indicate that M5181 is an effective treatment for plaque~     psoriasis.~      Based on the results of previous phase II trials the phase III trial has been designed to~     evaluate efficacy and safety of an 8-week treatment period with 50 μg/g M518101 in a larger~     population of patients with stable plaque psoriasis.~   "
120566|NCT01989416|"~     The purpose of this study is to determine 2% chlorhexidine wipes are effective in preventing~     of colonization of multi-drug resistant bacteria in intensive care unit patients.~   "
120567|NCT01989403|"~     The investigators report management of lumbar disc herniation with severe sciatic pain using~     an integrative complementary and alternative medicine approach with a 5 year follow-up.~   "
120568|NCT01989364|"~     Background: The Apparent Diffusion Coefficient (ADC) acquired by Diffusion Weighted Imaging~     (DWI-MR) has been shown to correlate with cellular density. The ADC is indicative of Gross~     Tumour Volume (GTV), and preliminary data shows that the dynamics of DWI volumes during~     treatment (shrinkage) as well as dose to DWI volumes has impact on treatment outcome.~      Hypoxic tumour cells within the primary tumour have been identified to have prognostic~     importance for local control Tumour hypoxia is caused by insufficiency of the tumour~     vasculature leading to both chronic diffusion limited and acute flow limited hypoxia.~     Radioresistant hypoxic cells diminish the rate of local control, and the hypoxia driven~     increase in metastatic potential of the tumour and lowers the rate of distant disease~     control. Functional imaging has the potential to visualise radioresistant tumour subvolumes.~     PET scanning (18F-FAZA) is hypothesized to visualise hypoxic tumour subvolumes, and dynamic~     contrast enhanced (DCE) MR imaging has been used to quantify the extent of poor perfusion~     regions within cervical tumours.~      Objectives:~      Primary:~      Sensitivity and specificity of functional imaging (18F-FAZA PET (optional), T1w, T2w, DWI-MRI~     and DCE-MRI) to identify tumours with good and bad response to radio-chemotherapy~      Secondary:~      Determining whether there are differences in bias between centre. The difference in bias will~     be assessed for the T1 and T2 scans and the Ktrans and ADC maps.~   "
120569|NCT01989351|"~     The study purpose is to examine polymorphism of genes associated to post-operative persistent~     pain and to verify the possible association between genotype phenotype and ADRB2 polymorphism~     in orthopaedic surgery. The primary aim is to evaluate the expression of ADBR2 in VAS>4~     patients and to compare it to those with VAS<4.~   "
120570|NCT01989338|"~     To investigate relationship between HV deformity and position of rearfoot joints, and its~     effects on the quality of life, pain, and related functional status in women with bilateral~     hallux valgus (HV).~   "
120571|NCT01989325|"~     This is a Phase 2 study during which patients with advanced multiple myeloma will receive~     either carfilzomib alone (single-agent) or carfilzomib in combination with investigational~     study drug filanesib (ARRY-520). Patients will be followed to determine the effectiveness of~     both single-agent carfilzomib and carfilzomib + filanesib in treating myeloma. Patients will~     be allowed to crossover from single-agent carfilzomib to carfilzomib + filanesib if disease~     progression occurs. Approximately 75 patients from the US will be enrolled in this study.~   "
120572|NCT01989312|"~     The aim of this study is to compare the combined ultrasound-guided supraclavicular brachial~     plexus block and distal median, radial, and ulnar nerve blocks, with supraclavicular block~     alone.~      Sixty two patients undergoing upper extremity surgery will be randomized to supraclavicular~     only (Group S, n=31) or supraclavicular + distal (Group SD, n=31) group. Patients in group S~     will receive 32 mL of lidocaine 1.5% + epinephrine 5µg/mL and in group SD receive 20 mL of~     lidocaine 1.5% + epinephrine 5µg/mL followed by a distal median, radial, and ulnar nerve~     blocks using 50:50 mixture of lidocaine 2% + levobupivacaine 0.5% (4 mL/nerve). Sensory and~     motor block of the ulnar, median, radial and musculocutaneous nerves will be assessed every 5~     minutes starting at the 10th minutes. The imaging, needling and performance times will be~     recorded. Also the onset and anesthesia related times, need for analgesic and first analgesic~     time will be noted.~   "
120573|NCT01989299|"~     Heart failure with preserved ejection fraction (HFPEF) is a large medical problem, for which~     no drug or device has a recommendation in current heart failure guidelines. Sudden cardiac~     death is suggested as the most common cause of death in HFPEF patients, although data is~     sparse. Use of an Implantable Loop Recorder (ILR) may be useful in patients with HFPEF to~     evaluate the incidence of sustained ventricular tachyarrhythmias. If ventricular~     tachyarrhythmias are seem frequently, treatment with an Implantable Cardioverter~     Defibrillator (ICD) may be an option in the future.~   "
120574|NCT01989286|"~     The positional plagiocephaly is a condition involving craniofacial asymmetry. The purpose of~     this study is to evaluate the spine, the posture and the psychomotor state in children who~     were diagnosed with infant plagiocephaly.~   "
120575|NCT01989273|"~     This is a study of patients admitted with major traumatic injuries. Such patients may develop~     inadequate circulation to the organs as a result of internal blood loss. Early detection of~     internal blood loss can be difficult as physical examination alone may miss patients with~     significant blood loss. Some patients with internal bleeding will arrive with low blood~     pressure; these patients are usually given 2 liters of intravenous fluid to determine if~     their blood pressure will recover. If the blood pressure does not rise or if it drops again~     later, the blood loss can be assumed to be severe, and the patient will likely need~     transfusions, surgery and other interventions. However, this fluid treatment method can lead~     to delays and complications as some patients may initially respond but then continue to~     bleed. The inferior vena cava (IVC) is the large vein draining blood from the lower body to~     the heart. The inferior vena cava is known to empty when the patient has had significant~     blood loss. The vena cava diameter can be seen using ultrasound. This study intends to~     perform ultrasound to examine the vena cava diameter on patients just after arriving with~     major trauma. The hypothesis of the proposed study is that an ultrasound assessment protocol~     of inferior vena cava diameter and collapsibility can detect and aid management of~     non-compressible hemorrhage in major trauma victims. After the patient has been given the 2~     liter intravenous fluid treatment, the inferior vena cava diameter will be measured again. A~     third examination 8-24 hours after admission will determine if the inferior vena cava~     diameter has returned to normal. We propose that measuring the inferior vena cava in this~     manner can predict those patients who are likely to continue bleeding and require~     interventions such as surgery. Early detection in these patients may avoid delays in~     treatment, complications and excess mortality. Because this examination is done with handheld~     ultrasound machines, it could be done outside hospitals and in military combat casualty care.~   "
120576|NCT01989260|"~     Endometriosis is a common gynaecological condition which typically present with pelvic pain~     and fertility problems. It is caused by tissues which are similar to the lining of the womb~     growing inside the women's pelvis. Severe endometriosis is most effectively treated using~     keyhole surgery. During the operation, endometriosis tissue is removed. However, following~     successful removal of endometriosis, women may still experience pain because the ovaries~     sometimes become stuck to the bottom of the pelvis due to post-operative scarring. We want to~     see if coating one of the ovaries in an anti-scar tissue gel stops the post-operative~     scarring.~   "
120577|NCT01989247|"~     The purpose of this study is to investigate whether citizens experiencing symptoms of anxiety~     and depression will benefit from a self-management training program with respect to: 1)~     Self-efficacy, and 2) Symptoms of anxiety and depression, and 3) Self reported measures of~     Health Related Quality of Life (HRQoL)~   "
120605|NCT01988883|"~     A common complaint among patients with Postural Tachycardia Syndrome (POTS) is brain fog or~     difficulty concentrating. This problem is poorly understood.~      The purpose of this study is to better understand the cognitive dysfunction associated POTS,~     and to determine optimal treatment strategies for this condition. In this study, the~     investigators will test the hypothesis that acute administration of the psychostimulant drug~     modafinil can improve seated measures of cognitive function in patients with POTS.~   "
120578|NCT01989234|"~     This will be a multi-center, randomized, double-blind, placebo-controlled study of YKP10811~     capsules in patients with chronic idiopathic constipation. Following a 2-week baseline~     period, approximately 320 eligible patients with <3 complete spontaneous bowel movements~     (CSBM) and ≤ 5 SBMs per week will be randomly assigned equally to receive one of the~     following oral treatments; placebo or YKP10811 capsules once daily for 12 weeks followed by a~     2 week follow-up period.~      The objectives of this study are:~        -  To assess the efficacy of YKP10811 once daily at relieving constipation and associated~          symptoms in subjects with chronic idiopathic constipation.~        -  To determine the safety and tolerability of YKP10811 once daily in subjects with chronic~          idiopathic constipation.~   "
120579|NCT01989221|"~     The aim of this study is to determine the efficacy of Sancuso® (granisetron transdermal~     system) 3.1 mg/24 hours in improving symptoms of nausea and vomiting in patients with~     gastroparesis. This will be a prospective open-label study using Sancuso® to treat symptoms~     of nausea and/or vomiting in patients diagnosed with gastroparesis. Symptomatic patients with~     diabetic or idiopathic gastroparesis with nausea and/or vomiting will be enrolled. The~     Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) will be used to capture the~     severity of symptoms, including nausea and vomiting, at baseline for one week. Patients will~     then be treated with Sancuso®. Patients will continue to fill out the GCSI-DD on a daily~     basis while undergoing treatment with Sancuso® for two weeks. To determine if Sancuso®~     treatment helps improve symptoms of nausea and vomiting, the symptoms at baseline will be~     compared to symptoms after the first week and the second week of treatment. Thirty patients~     diagnosed with gastroparesis (approximately 15 with diabetic and 15 with idiopathic~     gastroparesis) will be treated on an open label basis with Sancuso®. The goal of this study~     is to demonstrate the efficacy of Sancuso® in treating nausea and/or vomiting in~     gastroparesis patients. Safety information will also be collected regarding any adverse~     effects. If the results are encouraging, as we expect them to be based on personal~     experience, a larger double blind study would be appropriate.~   "
120580|NCT01989208|"~     Patients with heart failure are reported to have lower levels of hydrogen sulfide in their~     blood, even though sulfur is available naturally in the diet. Hydrogen sulfide is a molecule~     that has been shown to have a number of beneficial effects and thus the low levels may~     contribute to the disease. This trial is testing whether a medical food product of synthetic~     sulfur molecules, SG1002, can overcome this deficit in blood levels of hydrogen sulfide.~   "
120581|NCT01989195|"~     The investigator hopes to introduce a novel MRI contrast agent with SeeMore ™ that directly~     defines viable myocardium. Identifying viable myocardium non-invasively using cardiac MRI is~     still a moving target and a question we plan to answer more definitively with the SeeMore ™~     contrast. Though well tested in small and large animals and Phase I & II clinical trials, the~     investigators would like to determine the efficacy of the SeeMore contrast further in a~     clinical setting.~      SeeMore is a new manganese (Mn)-based intravenous imaging agent being developed to enhance~     magnetic resonance imaging (MRI). While Mn has long been known to have desirable magnetic and~     kinetic properties for MRI, use in humans was not initially possible due to cardiovascular~     depression and electrocardiogram (ECG) changes, including prolongation of PR and QTc~     intervals, associated with intravenous administration [1-5]. SeeMore provides Mn in a form~     that maintains the desired magnetic and kinetic properties while overcoming the~     cardiovascular toxicity of Mn. SeeMore is taken up into heart cells (primarily via addition~     of calcium to avoid cardiotoxic effects; please refer to US patent #5,980,863). The potential~     to distinguish healthy heart tissue from unhealthy heart tissue based on a specific sustained~     pattern of enhancement provides a basis for evaluating the performance of SeeMore in heart~     patients. It may be possible to enhance the utility of MRI for heart disease through the use~     of an imaging agent that is specifically taken up into heart cells. SeeMore is the only~     cardiac-specific agent being developed for this purpose. Unlike nuclear perfusion agents,~     SeeMore is not radioactive and does not require special handling, shielding, transport or~     storage. In addition, the specific pattern of enhancement achieved in the heart muscle~     persists over time, offering potential benefits over the nonspecific extracellular agents~     currently available for MRI or X-ray/CT procedures. This feature allows full use of the high~     resolution of MRI, since there is not a trade-off of high spatial resolution for temporal~     (first-pass) resolution. It is anticipated the features offered by SeeMore along with the~     high resolution, three dimensional attributes of MRI will result in higher accuracy than is~     available with other current modalities in practice, including stress echocardiograms,~     cardiac MRI using gadolinium contrast and nuclear studies such as SPECT and PET. This will be~     evaluated in this study and serve as the basis for pivotal registration studies.~      All components of SeeMore™ are USP and are approved for use as drugs in man, orally and/or~     intravenously.~   "
120582|NCT01989182|"~     This is a multicenter, prospective, randomized, controlled study being conducted in China to~     evaluate improvement of lung function after treatment with the Spiration Valve System as~     compared to medical management in the control group. The control group will be evaluated in~     the same manner as the treatment group.~      The Spiration Valve is a small, umbrella-shaped, one-way valve that is placed inside the~     airways of one lung. It is used to redirect air from the less healthy to the more healthy~     parts of the lung. This helps to reduce over-inflation and may improve overall lung function~     and quality of life for people living with emphysema.~   "
120583|NCT01989169|"~     A Study to Evaluate the Pharmacokinetic Interaction Between SSP-004184 and Midazolam in~     Healthy Adult Subjects~   "
120584|NCT01989156|"~     Evaluate if the ad libitum use of the THS 2.2 Menthol (mTHS), a candidate Modified Risk~     Tobacco Product, for 5 days in confinement, and after 86 days in an ambulatory setting, by~     apparently adult healthy smokers results in a reduction in the levels of biomarkers of~     exposure (BoExp) to selected harmful and potentially harmful constituents (HPHCs).~   "
120585|NCT01989143|"~     This single and multiple ascending dose study is a first in human assessment of PF-06480605.~     The goal is to study the safety, tolerability, pharmacokinetics and pharmacodynamics.~   "
120586|NCT01989130|"~     The purpose of this study is to determine if immediate availability of GeneXpert® CT/NG test~     results reduces the overtreatment rate for ED patients with suspected gonorrhea or chlamydia~     and to assess changes in clinician management decisions with real-time test results.~   "
120587|NCT01989117|"~     Osteopathy is an alternative healthcare that seems effective in relieving the pain of~     patients. The main purpose of this study is to evaluate the efficacy of preoperative~     osteopathic care in patients undergoing total knee arthroplasty (TKA) for osteoarthritis. The~     secondary objectives are to assess pain during the first postoperative month on a VAS and~     knee function and quality of life at 6 months and 1 year. Our hypothesis is that osteopathy~     will decrease postoperative pain and increase knee function.~   "
120588|NCT01989104|"~     The purpose of this study is to measure and link cadence (number of steps taken in a minute)~     to intensity of physical activity (e.g., low-intensity, moderate-intensity,~     vigorous-intensity) in children and adolescents (6-20 years-old), and to identify the cadence~     values corresponding to children's and adolescent's behavior during simulated free-living~     activities.~   "
120589|NCT01989091|"~     Hypothesis: B-Lock is a safe and effective catheter lock solution that will maintain catheter~     patency and reduce Central Line Associated Blood Stream Infections (CLABSI) in dialysis~     patients using a central venous catheter (CVC) for vascular access.~      The study is a prospective, randomized, site unblinded/sponsor blinded, clinical study of a~     minimum of 300 dialysis patients using a central venous catheter (CVC) for vascular access.~     Patients will be randomized 1:1 to receive either the investigational medical device (B-Lock~     or IMD) or active control heparin (5000 U/mL) (ACH) and observed for a minimum of 45 days or~     a maximum of 273 (expected average 160 days). IMD or ACH will be instilled into the catheter~     lumens (dual lumen catheters) at the end of each dialysis session and removed prior to the~     initiation of the next dialysis session.~      The primary objectives of this study are:~        -  To demonstrate the safety of B-Lock in dialysis patients~        -  To demonstrate the non-inferiority or, if proven to be non-inferior, superiority of~          B-Lock relative to ACH with respect to maintaining catheter patency as defined by the~          use of recombinant tissue plasminogen activator for maintaining adequate blood flow~          through the dialysis catheter~        -  To demonstrate the superiority of B-Lock relative to ACH with respect to the incidence~          of CLABSI~   "
120590|NCT01989078|"~     Sickle cell nephropathy (SCN) is a progressive complication of sickle cell disease (SCD) that~     begins in childhood and results in renal (kidney) failure and early mortality in nearly 12%~     of adults with hemoglobin SS (HbSS). The potential for prevention and reversal of kidney~     damage in SCD is not known. Albuminuria is a commonly used biomarker of glomerular damage;~     however the correlations of albuminuria with specific measurements of glomerular function and~     pathophysiology have not been determined. The investigators hypothesize that in patients with~     persistent albuminuria despite treatment of SCD with hydroxyurea, losartan will reverse~     kidney dysfunction in early stage nephropathy and ameliorate progressive kidney dysfunction~     in more advanced nephropathy. The primary aim is to study the acute and longer-term effects~     of losartan (study drug) on specific glomerular functions in children and adults with SCD who~     have persistent albuminuria. Research glomerular function tests will be done at study entry~     (prior to taking losartan), 1 month, and 1 to 2 years after starting losartan therapy~     (participants may take losartan for up to 24 months). In addition, participants are seen each~     month in clinic and assessed by their regular clinical team. The second aim is to assess the~     correlation of changes in albuminuria after 1 month of losartan with changes in direct~     measurements of glomerular function at 12-24 months, thus determining if the magnitude of the~     initial decrease in albuminuria in response to losartan predicts sustained improvements in~     renal function.~   "
120591|NCT01989065|"~     Outpatient childhood obesity treatment has limited efficacy. This study aims to improve the~     health habits of parents of obese 5-12 year old children enrolled in the Duke Healthy~     Lifestyles Program by delivering educational and supportive text messages to the parent's~     mobile device.~   "
120592|NCT01989052|"~     This is a Phase 1/2 study of the combination of CTO with lomustine in patients with recurrent~     malignant glioma to be treated at the Preston Robert Tisch Brain Tumor Center (PRTBTC) at~     Duke. The Primary Objectives are:~        -  Phase 1: To determine the maximum tolerated dose (MTD) of CTO when combined with~          lomustine among patients with recurrent malignant glioma (World Health Organization~          (WHO) grade III or IV) who have not been previously treated with bevacizumab.~        -  Phase 2: To assess the efficacy of CTO (either in monotherapy or in combination with~          lomustine) compared to lomustine alone in patients with recurrent WHO grade IV malignant~          gliomas that have not been previously treated with bevacizumab based upon 6-month~          progression free survival (PFS6).~      Note: This study was terminated early due to funding issues. At the time of termination, the~     study was still in Phase 1 and no MTD for the combination of CTO and lomustine had been~     determined for this population. Phase 2 will not proceed.~   "
120593|NCT01989039|"~     FPCOS is associated with an adverse cardiometabolic profile, consisting of increased total or~     central adiposity, increased insulin resistance and abnormal glucose metabolism. Low-grade~     chronic inflammation predicts cardiovascular outcomes and is observed in women with PCOS.~     However, obesity is also associated with increased inflammatory markers. Obesity is per se~     associated with increased adipose expression and plasma levels of leptin, lower expression of~     adiponectin, and elevated inflammatory markers. To study the insulin resistance、inflammatory~     markers and cardiovascular risk in women with PCOS, body weight status should be considered.~     Investigator therefore conduct this retrospective study to evaluate the insulin~     resistance、inflammatory and cardiovascular markers between PCOS and non-PCOS among obese and~     non-obese women.~   "
120594|NCT01989026|"~     Recent studies show that BCG vaccination reduces neonatal mortality by more than 40%. This~     effect cannot be explained by prevention of tuberculosis, which is very rare among infants.~     The protective effect of BCG vaccination is seen already within the first week. It seems that~     BCG provides a non-specific beneficial immune modulation - thereby reducing overall~     mortality. Mortality is very high among newborns admitted to the neonatal intensive care~     unit. If BCG has immediate beneficial effects on the immune system, vaccinating children with~     BCG as early as possible may save lives. The investigators will test this hypothesis in a~     randomized trial among newborns in Guinea-Bissau, randomizing newborns admitted to the~     neonatal intensive care unit at the National Hospital 1:1 to BCG immediately or at discharge~     (usual practice).~   "
120595|NCT01989013|"~     We are studying & researching the effect of CranioSacral Integrative therapy on Parkinson's~     Diseased Patients for 3 months. With a therapeutic induction via manual CranioSacral~     integrative therapy for 90 minutes per session with a total of 2 session divided equally in a~     month (biweekly intervention). At the end of 3 months each patient will have total of 9 hours~     of CranioSacral Integrative therapy induced, we will document the symptoms and shortcomings~     of the patients at evaluation, before and after therapeutic treatment on a measured scale~     ranging from 1-10. Finally graphically and statistically measure the quality of change in the~     symptoms at the end of 3 months and provide executive summary of the research finding, which~     the investigators expect to be a positive one.~   "
121021|NCT01983410|"~     The purpose of this study is to better understand why pancreatic cancer develops in some~     people who are known carriers of the gene mutation (an abnormality) called BRCA, or its close~     relative PALB2. The investigators hope to do this by establishing a BRCA/PALB2 mutation~     carriers Pancreatic Ductal Adenocarcinoma (the common form of pancreatic cancer) Registry. A~     registry is a database of information.~   "
120596|NCT01989000|"~     Pancreatic cancer is a highly lethal disease. Patients with resectable or borderline~     resectable disease may benefit from preoperative radiochemotherapy. However, only a subset of~     patients will respond to this potentially toxic and expensive treatment. Therefore, novel~     predictive markers are needed to determine treatment efficacy at an early stage. Preferably,~     these markers could be determined non-invasively and provide insight into the biology of~     pancreatic cancer. Pancreatic cancers are heterogeneous tumors. The tumor microenvironment is~     often characterized by large amounts of stroma, hypovascularization, and hypoxia. As these~     three factors can all contribute to treatment resistance, a quantitative assessment of these~     markers may aid in the prediction of response to preoperative radiochemotherapy. Moreover,~     these assessments may have prognostic value. Finally, further insight into the interrelation~     of these aspects of the tumor microenvironment can contribute to the evaluation of new~     targeted treatment options. Tumor cellularity and extracellular matrix composition can be~     assessed non-invasively in vivo by diffusion weighted magnetic resonance imaging (DWI) and~     tumor vascularity can be assessed by dynamic contrast enhanced magnetic resonance imaging~     (DCE-MRI). Finally, tumor hypoxia can be evaluated by T2* MRI and PET-CT, using the~     18F-labeled hypoxic marker HX4.~      Objective of the study:~      The primary aim of the study is to assess whether DWI, DCE-MRI, T2*, and 18F-HX4-PET/CT~     predict overall survival in patients with pancreatic cancer treated with surgery and adjuvant~     chemotherapy or with neoadjuvant radiochemotherapy, surgery and adjuvant chemotherapy.~     Secondary aims of the study include the assessment of the predictive value of DWI, DCE-MRI,~     T2*, and 18F-HX4-PET/CT for pathological response to neoadjuvant chemoradiation, the~     correlation of DWI, DCE-MRI, T2*, and 18F-HX4-PET/CT with histopathological assessment of~     tumor stroma, vascularization, and hypoxia, and the assessment of the predictive value of~     these histopathological markers for overall survival.~   "
120597|NCT01988987|"~     Pregnancy-associated diabetes, known as gestational diabetes mellitus (GDM), is associated~     with an increased lifetime risk of developing diabetes mellitus (DM) or pre-diabetes. Up to~     30% of women with GDM will continue have abnormal blood glucose tests 6 or more weeks after~     delivery. Early diagnosis and treatment of continued impaired glucose metabolism or DM is~     essential because serious health problems can result.~      Current guidelines recommend a 75-gram, 2-hour glucose tolerance test (GTT) 6 or more weeks~     after delivery for women diagnosed with GDM in order to identify those with continued DM or~     impaired glucose metabolism. However, approximately half of these women do not get glucose~     testing after delivery. The ability to test women while they are still hospitalized after~     having a baby could greatly increase diagnosis, care and treatment of women with abnormal~     glucose metabolism.~      Our objective is to determine if a 75-gram, 2-hour GTT administered to women with GDM two to~     four days after delivery can identify those who will have an abnormal GTT at 6-12 weeks after~     delivery.~   "
120598|NCT01988974|"~     The purpose of this study is to determine the psychometric properties of the Knowledge,~     Attitudes, and Beliefs about Atrial Fibrillation Survey (KABAFS) and to generate critical,~     practical knowledge about the feasibility of conducting a randomized trial to test the effect~     of the Alert for Atrial Fibrillation program on treatment-seeking for symptoms of Atrial~     Fibrillation (AF).~   "
120599|NCT01988961|"~     The purpose of this study is to evaluate the accuracy of a subset of the length-109 probe set~     panel (a genetic test) in predicting response to golimumab treatment in participants with~     moderately to severely active ulcerative colitis (UC).~   "
120600|NCT01988948|"~     Human papillomavirus (HPV) infection is the most common sexually transmitted infection. The~     high risk oncogenic types, HPV-16 and -18 are responsible for 70% of cervical cancers. The~     introduction of vaccination against two major oncogenic genotypes of HPV raises questions~     about genotype replacement because of the existence of other oncogenic types not targeted by~     the vaccine. A better understanding of natural history of HPV infection and interaction~     (competition, synergy) between genotypes are required in order to anticipate this phenomenon.~      The aims of this study are to characterize HPV infection in young female students and to~     follow up HPV infection and co-infection dynamics with different genotypes, taking into~     account both vaccination status and immunity to HPV 16 and 18. The study also focuses on the~     determination of factors influencing the development of persistent cervical HPV infections.~      The DyPAVIR-ISHARE study is based on the participation of 5000 young female students, from 18~     to 20 years-old, all registered at the Universities of Bordeaux or Versailles Saint-Quentin~     (UVSQ). The 3-years follow-up includes completion of a self-administrated questionnaire~     regarding sexual behaviour, socio-demographic characteristics, access to health-care services~     and, for a sub-group of 1000 students, the taking of genital and oral self-taken samples for~     the detection and genotyping of HPV (every 3 months). Previously, a pilot phase study (2~     visits in 3 months of interval) is set up on 50 young female students from UVSQ in order to~     test feasibility.~      This study will provide data to gain insight into the possibility of type replacement.~     Moreover, this study would provide an overview of HPV vaccine coverage and effectiveness HPV~     incidence and factors associated with HPV infection and co-infection ; Partners recruitment~     would allow us to follow HPV transmission dynamics among couples, and in particular, HPV~     exposure in young adult women. The HPV research won't be limited to virus detection in~     samples but will indicate the presence or absence of HPV infection.~      Finally, additional genetic studies could be conducted in order to study genetic~     susceptibility to HPV infection, to chronic HPV infection and to co-infection.~      This research project is part of the i-Share program funded by the Investissement d'Avenir~     cohort call.~   "
120601|NCT01988935|"~     Research shows that people with PTSD are more likely to smoke than people without PTSD. It~     also shows that people with PTSD have more difficulty at attempts to quit smoking. This study~     is part of a program aimed at finding out how best to help smokers quit who also have PTSD.~     One option is to give patients standard smoking cessation treatment including nicotine~     replacement and cognitive behavioral therapy. Another option is to give patients the standard~     smoking cessation treatment in addition to treatment for their PTSD symptoms (called~     prolonged exposure). However, it is not known which method works better. In order to answer~     this question, patients will be assigned by chance to one of two groups. One group will be~     given standard smoking cessation treatment to help quit smoking. A second group will be given~     the standard smoking cessation intervention to help quit smoking in addition to a form of~     psychotherapy called Prolonged Exposure to reduce symptoms of PTSD. The patients will be~     randomly assigned (by chance) to one of these groups. If the patient is assigned to the~     smoking cessation only condition and the patient still has PTSD symptoms after the last study~     visit (week 30) the patient will be offered treatment for your PTSD symptoms (Prolonged~     Exposure) at no cost. The patient's participation will help the investigators determine if~     treating PTSD symptoms enhances the ability of standard smoking cessation to help people quit~     smoking.~   "
120602|NCT01988922|"~     This research study will determine if genetic variation in CYP2B6 affects how the body~     metabolizes ketamine.~   "
120603|NCT01988909|"~     The objectives of the study are to evaluate the safety and efficacy of open label treatment~     with WR 279,396 (topical paromomycin & gentamicin) in patients with non-complicated,~     non-severe cutaneous leishmaniasis (CL).~   "
120604|NCT01988896|"~     This is a Phase Ib, open-label, multicenter study designed to assess the safety,~     tolerability, and pharmacokinetics of coadministration of intravenous (IV) dosing of~     atezolizumab (an engineered anti-programmed death-ligand 1 [anti-PD-L1] antibody) and oral~     dosing of cobimetinib in participants with metastatic or locally advanced cancer for which no~     standard therapy exists.~   "
121022|NCT01983397|"~     The purpose of this study is to compare the effects of different trainings on cognition and~     physical performances in elderly over 80 years.~   "
128860|NCT01880736|"~     This trial is conducted in Asia. The aim of the trial is to investigate the efficacy and~     safety of flexible versus fixed dosing and simple versus stepwise titration with OD insulin~     degludec in inadequately treated subjects with type 2 diabetes.~   "
120606|NCT01988870|"~     The purpose of this study is to evaluate an investigational way to provide radiation therapy~     to treat breast cancer at the time of surgery.~      Traditionally, the recommended treatment for early stage breast cancer is surgery to remove~     the tumor, followed by whole breast radiation therapy to decrease the chance of recurrence of~     the cancer. Whole breast radiation involves daily radiation treatments for 4-6 weeks and can~     be associated with damage to other tissues including the skin. Recent technological advances~     have made it possible to provide radiation treatment during the breast cancer surgical~     procedure. This procedure is called intraoperative radiation therapy (IORT). The University~     of Virginia has a unique IORT system which allows for the inclusion of cutting edge imaging~     technology into the IORT procedure in order to provide delivery of radiation directly to the~     needed areas and to avoid radiation to other tissues.~   "
120607|NCT01988857|"~     This study will evaluate the safety and reactogenicity of GSK Biologicals' combined~     reduced-antigen-content diphtheria-tetanus-acellular pertussis (dTpa) vaccine, Boostrix™ when~     given as a single injection to 6-10 year old children. Data that are available globally on~     the age group from four to six years of age will be used to bridge the age gap in this study~     and aid in the registration of the vaccine for children from the age of four years.~   "
120608|NCT01988844|"~     Cerebral palsy is the leading cause of physical disability among children. Manual dexterity~     and upper limbs functionality is limited between these children. The purpose of this study is~     to stablish a specific profile of school children with cerebral palsy based on the upper~     limbs assessment.~   "
120609|NCT01988831|"~     Melanoma's incidence is increasing worldwide. The efforts made in melanoma screening led to~     an earlier detection of the primary tumour and a better prognosis, but melanoma remains an~     aggressive cancer when it comes to its metastatic stage. Three recent retrospective studies~     compared groups of patients diagnosed with primary melanoma and treated with betablockers for~     another indication to patients who never received betablockers. In these three studies, the~     outcome of the disease is significantly better for people under betablocker treatment with a~     decreased rate of recurrence and a better 5 years survival rate. Here we want to investigate~     the efficacy and the tolerability of an adjuvant treatment with propranolol for patients~     suffering from a primary melanoma with a high risk of recurrence.~   "
120610|NCT01988818|"~     The primary objective of this investigation is to evaluate the performance of a self-adhesive~     absorbent post-operative dressing coated with a soft silicone layer in minimize the risk of~     the development of blistering in subjects after hip or knee arthroplasty or spinal surgery in~     comparison to a standard wound dressing The secondary objectives are to evaluate:~        -  the performance of the dressing~        -  the comfort, conformability and the acceptability of the dressing~        -  pain before, during and after dressing removal~        -  the overall cost regarding dressing wear time, time to do dressing change and personal~          resources needed~   "
120611|NCT01988805|"~     This study is intended to collect blood from healthy individuals to investigate whether~     variations in immune-related (inflammasome) genes affect how the immune cells found in the~     blood can help fight infections and prevent diseases.~   "
120612|NCT01988792|"~     The purpose of this study to find out how safely we can add extra nutrients to human milk at~     different feeding volume.~   "
120613|NCT01988779|"~     The purpose of this study is to treat patients with a diagnosis of chronic rhinosinusitis~     (CRS) and a history of bilateral endoscopic sinus surgery during times of worsening symptoms~     and signs of acute infection on nasal endoscopy with one of two treatments: (1) oral~     antibiotics and twice daily intranasal saline irrigations or (2) oral placebo and twice daily~     intranasal antibiotic irrigations. The two treatments will be compared to see if there is any~     difference in patient outcomes. This will help guide treatment strategies for patients with~     CRS in the future.~   "
120614|NCT01988766|"~     The purpose of this study is to compare the difference in thrombosis as a result of internal~     jugular (IJ) catheters versus peripherally inserted central catheter (PICC) lines. It is~     hypothesized that there will be a decreased rate of thrombosis in patients as a result of IJ~     catheters verses PICC lines.~   "
120615|NCT01988753|"~     This study is being conducted to develop new techniques for early diagnosis of liver disease.~     These techniques are: Shearwave Elastography (SWE) ultrasound and blood biomarkers.~      SWE ultrasound uses high-frequency sound waves to view soft tissues such as muscles and~     internal organs and measure stiffness. An ultrasound creates computer images that show~     internal body organs, such as the liver or kidneys, more clearly than regular x-ray images.~      Biomarkers are biological molecules found in the blood that provide important information~     about liver disease.~   "
120616|NCT01988740|"~     The finding that ischemia-modified albumin (IMA) is increased in pre-eclamptic pregnancy~     suggests a role for IMA as a potential biomarker for abnormal placental development related~     to miscarriage.This study was undertaken to evaluate IMA levels in women with recurrent~     pregnancy loss (RPL).~   "
120617|NCT01988714|"~     The purpose of this study is to investigate the usefulness of neuroscience-guided cognitive~     training combined with community-based supported employment for people with schizophrenia.~     The investigators will examine the effectiveness of moving our study of neuroplasticity-based~     restorative targeted cognitive training out of the laboratory and into the community setting;~     and the investigators will also investigate its utility in enhancing functional outcome in~     chronically mentally ill adults who are participating in supported employment.~   "
120618|NCT01988701|"~     This research trial studies lymphocyte profiles and activation status in patients with~     graft-versus-host disease. Studying samples of blood in the laboratory from patients with~     cancer may help doctors identify and learn more about biomarkers related to graft-versus-host~     disease.~   "
120619|NCT01988688|"~     This study will test the safety and effectiveness of deep brain stimulation (DBS) for~     patients with a big or very big problem with tinnitus (a sensation of noise in the head).~   "
120620|NCT01988675|"~     This is a study to determine if Magnetic Resonance Imaging (MRI) techniques can detect early~     changes in white matter (in the brain) and the blood-brain barrier resulting from radiation~     therapy.~   "
120621|NCT01988662|"~     This study assessed systemic vascular endothelial growth factor (VEGF) level in patients with~     neovascular Age-related Macular Degeneration following treatment with Ranibizumab or~     Aflibercept.~      Free plasma VEGF-A level was measured in this study .~   "
120622|NCT01988649|"~     Oxytocin is neurohypophysial peptide that acts mainly as a neuromodulator in the brain. In~     addition,oxytocin have an important roles in sexual reproduction , in particular during and~     after childbirth. It facilitates birth, maternal bonding, and, breastfeeding. Nasal oxytocin~     has been commonly used to improve breastfeeding in lactating women. A review of safety , side~     effects and subjective reaction to intranasal oxytocin in human research in 1529 subjects did~     not review any differences from placebo. The vast majority of basic science studies suggested~     a large effect of oxytocin in minimizing acute pain.4 Few studies have demonstrated an~     association between plasma levels of oxytocin and pain in humans. No studies have examined~     the effect of intranasal oxytocin on pain sensitivity and threshold. Since addictive~     properties of oxytocin have not been described, the drug may have important application in~     the management of acute and chronic pain.~      The main objective of the current investigation was to evaluate the effect of intranasal~     oxytocin on pain sensitivity and threshold in human volunteers. We hypothesized that~     intranasal oxytocin, in human volunteers ,would decrease sensitivity and and increase pain~     threshold compared to intranasal saline .~      Significance: Intranasal oxytocin may become a viable treatment for acute and chronic pain in~     humans.~   "
120623|NCT01988636|"~     Background:~      - Malaria is caused by small germs carried by mosquitoes. People can get malaria if an~     infected mosquito bites them. Malaria destroys red blood cells and reduces oxygen in the~     blood. Most malaria is mild, but severe malaria kills at least 660,000 people each year.~     About 75% of these are children in Sub-Saharan Africa, most under age 5. Researchers want to~     find a safe vaccine that helps prevent malaria.~      Objectives:~      - To see if a new malaria vaccine is well tolerated and effective.~      Eligibility:~      - Healthy adults 18 35 years old who are not pregnant and live in Mali.~      Design:~        -  Participants will be screened with medical history, physical exam, and blood test. They~          will also have an ECG. Soft electrodes will be stuck to the skin. A machine will record~          the heart s electrical signals.~        -  Study participation will last about 1 year.~        -  Participants will be randomly placed in 5 groups. Some will get 2 doses of the PfSPZ~          vaccine weeks apart; some will get 3 or 5 doses of vaccine; some will get 3 or 5 doses~          of placebo.~        -  Doses will be given through a needle in the arm directly into the bloodstream. Then~          participants must stay at the clinic for 2 hours.~        -  After each dose, participants will return to the clinic several times for blood tests~          and physical exam.~        -  A week before the first dose and 2 weeks after the last, participants will take a full~          course of anti-malaria drugs.~        -  If a participant gets malaria during the study, they will take another course of~          anti-malaria drugs.~   "
120624|NCT01988623|"~     The investigators will assess the efficacy of Pivotal Response Treatment (PRT) in the~     treatment of communication deficits in children with intellectual disabilities. By collecting~     information about parent and child functioning before and after PRT, The investigators will~     be able to determine whether the intervention is effective in improving child communication~     and reducing parent stress.~   "
120625|NCT01988610|"~     The purpose of this study is to study the effect of cortisol,a stress hormone in the body, on~     memory and attention in people with a history of depression, but who are not in the midst of~     a current depressive episode.~      Cortisol may affect parts of the brain associated with memory and attention directly. It may~     also indirectly affect the brain by controlling how much insulin the body makes. Insulin is~     thought to impact cognition by changing the amount of sugar available in certain parts of the~     brain.~      The investigators are studying this question by giving patients a medication, called~     Mifepristone, which reduces cortisol's effect on the brain. The investigators will compare~     results from several groups of people, including differences between men and women, and~     between those with and without insulin resistance.~   "
120626|NCT01988597|"~     Dry eye syndrome is a very common condition with multiple etiologies that includes systemic~     and ocular disease that causes reduction in the production of tears, as well as increase in~     tears evaporation. As a result of the various etiologies and large variability of dry eye's~     clinical sign, it has been a challenge for practitioners to have a consistent system to~     classify dry eyes and to have an appropriate and accurate measurement to quantify the~     severity of dry eyes and its impact on patients' quality of life.6 To date, no study which~     evaluates the extent of questionnaires correlates with changes in quality of life. With this~     cross sectional interview study, we aim to determine the efficacy of the questionnaires as a~     practical tool in our future clinical trials at our center.~   "
120627|NCT01988584|"~     The purpose of this study is to compare the safety and effectiveness of two types of stem~     cells,(either banked cord blood or bone marrow), in children between the ages of 2 to 10~     years with CP. 15 children with banked cord blood at CBR and 15 children without banked cord~     blood will be enrolled into the study. The study involves one baseline/treatment visit and 3~     follow-up visits at 6 months, 12 months, and 2 years. Five children in each group will be~     randomized to a placebo control group at the baseline/treatment visit. Parents will not be~     told if their child received stem cells or a placebo until the 12 month follow-up visit. At~     that time parents may elect to have their child receive the stem cell treatment; either bone~     morrow harvest or umbilical cord blood if banked with CBR. All study visits will be conducted~     at the UTHealth Medical School and Children's Memorial Hermann Hospital in Houston, Texas.~      As of 1/21/2014 we have met our enrollment limit for children without banked cord blood~     undergoing bone marrow harvest for stem cells.~   "
120628|NCT01988571|"~     The purpose of this research study is to see if Atorvastatin(Lipitor) 40 mg by mouth daily~     decreases the chance of developing heart problems in women receiving adjuvant~     anthracycline-based chemotherapy for breast cancer.~   "
120629|NCT01988558|"~     The study objectives are to evaluate Tonsitin™ (10% Lactic Acid) safety, tolerability and~     preliminary efficacy, as a potent treatment for Recurrent Tonsillitis in children.~   "
120630|NCT01988545|"~     to investigate the effect of the human incretin hormone GLP-1 on mesenteric blood flow and~     cardiac parameters~   "
120631|NCT01988532|"~     This study is conducted in the United States of America (USA). The aim of the study is to~     assess the impact of pain on functional impairment and quality of life in adult persons with~     hemophilia (PWH) with and without inhibitors with joint bleeding.~   "
129125|NCT01877252|"~     The principal research question is which treatment modality between open surgical,~     endovascular and conservative therapy is the most effective in terms of limb salvage,~     survival and reinterventions in patients with critical limb ischemia~   "
120632|NCT01988519|"~     Pancreatic resection is the only potentially curative modality of treatment for pancreatic~     neoplasm. The mortality associated with this procedure decreased rapidly in the past decades.~     However, the morbidity associated with pancreatic resection remains high. The main reason for~     postoperative morbidity is postoperative pancreatic fistula (POPF), which is regarded as the~     most ominous complication following pancreatic resection. Its reported incidence varies in~     the surgical literature from 10% to >30%.~      Recently published studies showed that the placement of intraoperative drains, manipulation~     with the drains, timing of removal of the drain, and especially the type of drain, have~     significant effect on the postoperative complications, and especially POPF.~      Controversy exists regarding the type of intraoperatively placed drain. Nowadays, the two~     most commonly used systems are closed suction drainage and closed gravity drainage. Open~     systems have been abandoned in most centers as they are obsolete.~      Our hypothesis is that the closed suction drain will have better results as it is more~     effective than the gravity drainage. However, some surgeons claim that the suction system can~     actively suck the pancreatic juice through the anastomosis or suture and thus promote the~     development of POPF.~      The aim of this study is to compare closed suction drains and closed gravity drains after~     pancreatic resection in a randomized controlled study.~      The primary end-point is the postoperative pancreatic fistula rate. The secondary end-point~     is the postoperative morbidity.~   "
120633|NCT01988506|"~     TRANSREG will assess the safety and biological efficacy of low-dose IL2 as a Treg inducer in~     a set of 14 autoimmune and auto-inflammatory diseases, with the aim to select diseases in~     which further therapeutic development will be performed. Extensive biological- and~     immune-monitoring pre- and post-IL2 will contribute (i) to define the common or distinct~     processes responsible for the breakdown of immunological tolerance in these pathologies and~     (ii) to discover potential biomarkers of the IL2 response.~   "
120634|NCT01988493|"~     This is an open-label, integrated, Phase 1b/2 trial to determine the recommended Phase 2 dose~     (RP2D) and to evaluate the efficacy, safety, and pharmacokinetic of MSC2156119J as first-line~     treatment versus sorafenib in subjects with MET+, Barcelona Clinic Liver Cancer (BCLC) Stage~     C, systemic treatment naive advanced hepatocellular carcinoma (HCC) and Child-Pugh class A~     liver function.~   "
120635|NCT01988480|"~     The objective of this study is to compare two surgical procedure to place implant in severely~     resorbed posterioir part of the maxilla.~   "
120636|NCT01988467|"~     The aim of this study was to compare the acute effects of second hand smoke exposure between~     nasal and oral breathing and to assess the potential protective role of the nose during acute~     exposure, in exposure conditions similar to those within a bar where smoking is permitted.~   "
120637|NCT01988454|"~     The primary objective of this pilot study is to characterize the profile of lipoprotein,~     inflammatory, and metabolic markers of cardiovascular disease in obese adolescents as~     compared to normal-weight age-matched controls.~   "
120638|NCT01988441|"~     Non-alcoholic fatty liver disease (NAFLD) is one of the most common causes of chronic liver~     disease worldwide. It is not known why only some obese subjects develop NAFLD. In recent~     years, a growing body of evidence showed a crucial role of autophagy in in the regulation of~     liver fat storage. The purpose of this study is to determine whether autophagy~     pathway-related genetic polymorphisms affect NAFLD.~   "
120639|NCT01988428|"~     Sepsis is one of the most frequent reasons for referral to emergency departments (EDs)~     worldwide. The incidence of sepsis is likely to rise in the upcoming years. Sepsis has a~     tendency to become more serious when left untreated with a high mortality rate, exceeding~     even those of myocardial infarction and stroke. Therefore, much effort has been put in to~     start with appropriate therapy as early as possible. Early goal-directed therapy (EGDT) in~     the emergency department with fluid resuscitation, administration of~     vasopressors/vasodilators and intravenous antibiotics in patients with severe sepsis and~     septic shock has indeed decreased mortality substantially. Emergency medical services (EMS)~     personnel have already made a significant difference in improving care for patients with~     acute coronary syndrome, multiple trauma and stroke. Patients with severe sepsis or septic~     shock could also benefit greatly from timely pre-hospital care. Earlier recognition and~     initiation of treatment by EMS personnel may improve survival even more.~      Interestingly, the first hour of ED presentation seems to be the most critical hour.~     Administration of antibiotics and fluid resuscitation in the pre-hospital setting will reduce~     the time to administration substantially. In adults, to the best of our knowledge, no studies~     on the effect of pre-hospital administration of antibiotics have been performed. In children~     with meningitis, some uncontrolled studies show contradictory results, most probably due to~     bias by severity. We propose a non-blinded randomised multicentre clinical trial study on the~     efficacy of early, pre-hospital intravenous administration of broad spectrum antibiotics~     (ceftriaxone), which are effective against a wide variety of infectious pathogens that cause~     most common community-acquired infections) in patients referred to the ED with suspected~     severe sepsis or septic shock.~      Objective: To evaluate whether early, pre-hospital administration of antibiotics, together~     with training of ambulance personnel in recognizing and initiating treatment reduces 28-day~     mortality in patients referred to the ED with suspected severe sepsis or septic shock~      Study design: Non-blinded randomized multicentre clinical trial nested within a stepped wedge~     design~      Study population: All patients above the age of 18 years, with suspected severe sepsis or~     septic shock and transferred to the ED by ambulance, are eligible for study inclusion~      Intervention: prehospital antibiotics (ceftriaxone 2000 mg intravenously)~      Main study parameters/endpoints: 28-day mortality, hospital length of stay, admission to~     intensive or medium care unit (ICU/MC), time to administration of antibiotics. Follow up of~     one year. QoL after one month after discharge.~   "
120640|NCT01988415|"~     The purpose of this clinical trial is to demonstrate that treatments generated by an~     investigational algorithm reduces spherical aberration compared to currently available~     iDesign treatments.~   "
120641|NCT01988402|"~     This is a double blind placebo controlled study to determine whether starting allopurinol~     during a treated acute gout attack will have any effect on the duration of the attack.~   "
120642|NCT01988389|"~     There is now considerable scientific evidence that a diet rich in fruits and vegetables could~     improve human health. Apples are among the most frequently consumed fruits in the world.~     Epidemiological studies have linked frequent apple consumption with several health benefits~     including a reduced risk of cardiovascular disease. Apples are an important source of~     polyphenols and fiber and their beneficial effects could be attributed to this content;~     however, their impact on our health is not clear. Although, there are some studies that have~     reported cholesterol lowering effects the results are inconsistent. Furthermore, few studies~     have explored the impact on vascular function and gut microbiota. The objective of the~     current study is to assess whether a regular apple consumption, reduces total cholesterol~     levels, improves vascular function and gut microbiota profile in mildly hypercholesterolemic~     subjects compared with a control, sugar matched commercial clear apple juice squash.~   "
121043|NCT01983124|"~     The purpose of this study is to evaluate the activity of Vemurafenib in combination with~     Fotemustine in Patients with unresectable Stage IV melanoma harboring V600 BRAF mutation who~     recurred while in treatment with Vemurafenib. In addition the feasibility and safety profile~     of prolonging treatment of this drugs combination will be assessed.~   "
120643|NCT01988376|"~     Background/Purpose: This is a large scale, multicenter randomized clinical trial to assess~     the feasibility of using SurePath® in cervical cancer patients after radiation therapy by~     comparing the incidence of unsatisfactory smear and the accuracy of detecting cervicovaginal~     lesions between the SurePath® and the conventional smear.~      Patients and Methods: The investigators will invite all women who had received radiotherapy~     for cervical cancer in the investigators outpatient clinics. All enrolled cases will ask to~     receive randomly the SurePath® or the conventional smear.~      Expected Results: The investigators will get the incidence of unsatisfactory smear and the~     accuracy of detecting cervicovaginal lesions between the SurePath® and the conventional smear~     in patients who underwent radiotherapy.~   "
120644|NCT01988363|"~     This study is designed to answer the question of whether injection of the greater occipital~     nerve at its proximal origin, near the C2 vertebrae, using ultrasound guidance is effective~     in improving pain in human subjects.~      HYPOTHESES~        1. Ultrasound (US) guided greater occipital nerve (GON) injections are effective at a~          novel, proximal C2 location in live, human subjects, measured by improvement in visual~          analog scale (VAS) pain scores pre-injection compared to VAS scores 30 minutes~          post-injection, 2-weeks post-injection, and 1-month post-injection .~        2. Ultrasound (US) guided injection of the greater occipital nerve (GON) at a novel, C2~          location is effective at improvement of both occipital neuralgia and cervicogenic~          headache demonstrated by improvement in visual analog scale (VAS) pain scores~          pre-injection compared to VAS scores 30 minutes post-injection, 2-weeks post-injection,~          and 1-month post-injection. We further hypothesize that the mean improvement in VAS~          scores at 1-month post injection will be greater than 2 units.~        3. Ultrasound (US) guided injection of the greater occipital nerve (GON) at novel, proximal~          C2 location in live, human subjects appears safe.~   "
120645|NCT01988350|"~     Pancreatic insufficiency is a condition in which there is a decrease in the production and~     release of enzymes made in the pancreas, which causes nutrient malabsorption. There are many~     chronic diseases that can lead to pancreatic insufficiency. In the early stages of this~     disease, a patient may not experience any symptoms, and the prevalence of pancreatic~     insufficiency may be underestimated. Smoking has long been recognized as a cause of disease~     in many organs in the body. Cigarette smoke causes inflammation and damages tissue, including~     the pancreas. Studies have shown that smoking is an independent risk factor for pancreatic~     cancer and chronic pancreatitis. It has also been shown that the more a person smokes, the~     worse his disease will be. Additionally, there are studies that show that smokers have~     nutritional deficiencies. There are observational and retrospective studies that suggest that~     pancreatic insufficiency may also be caused by smoking. However, this has not been~     established, and the relationship has not been examined in a controlled manner. This study~     examines the relationship between smoking and pancreatic insufficiency in patients who do not~     have other pancreatic diseases.~   "
120646|NCT01988337|"~     This is a three year single site clinical evaluation of a FDA approved (510(k):K100062)~     lesion penetrating resin used to infiltrate and hamper progression of proximal carious~     lesions. The purpose of this study is to compare lesion progression infiltrated with (Icon,~     Hamburg, Germany) to a similar sized lesion in the same patient treated with a placebo. The~     study is designed as a randomized, controlled, prospective clinical trial with a three year~     follow-up evaluation period.~      The clinical site will enroll 150 subjects (in the age range of 19 years or older) with 2~     study lesions. The patients will be evaluated at six time points over a period of 3 years.~     Lesion status and caries risk will be monitored at 6-month intervals, while radiographic~     evaluation will be conducted at 12-month intervals at 1-, 2- and 3-year recall visits.~   "
120647|NCT01988324|"~     Knowledge of breast cancer estrogen receptor (ER) expression is of major importance in~     treatment-decision making. Patients with ER-positive tumors can be treated with~     anti-oestrogen therapy, which has relatively few side effects compared to chemotherapy.~     Whole-body tumor ER-expression can be visualized by 18F-fluoroestradiol PET imaging~     (FES-PET). In addition to ER, the androgen receptor (AR) is a potential new target in breast~     cancer. PET imaging with 18F-fluorodihydrotestosterone (18F-FDHT) may allow visualization of~     tumor AR-expression. In the current study we will perform FES-PET and FDHT-PET in metastatic~     breast cancer patients and evaluate the concordance with concurrent biopsies. Molecular~     imaging of tumor AR- and ER-expression may well be of value for future treatment~     decision-making.~   "
120648|NCT01988311|"~     This is a pilot study to finalize methods for a larger study being planned for the future.~     This research is being done to characterize performance of tasks, brain functioning, and the~     effects of psilocybin in individuals with a long-term meditation practice.~      There are three different parts of the pilot study:~        1. Effects of psilocybin on psychological function: This version of the pilot study will~          involve 1 or 2 day-long psilocybin sessions, and several meetings and data assessment~          visits. You will make a total of about 5 to 10 visits to our research unit (the BPRU on~          the Johns Hopkins Bayview Campus).~        2. Performance on behavioral and cognitive tasks: This version of the pilot study will~          involve completing various behavioral and cognitive tasks at our research unit. You will~          make a total of about 1-10 visits to our research unit (the BPRU on the Johns Hopkins~          Bayview Campus).~        3. Brain functioning: This version of the study will involve 1 to 3 brain imaging (MRI)~          measurements. You will make a total of about 2 to 5 visits to our research unit (the~          BPRU on the Johns Hopkins Bayview Campus). The MRI measurements will be taken at the~          F.M. Kirby Research Center at the Kennedy Krieger Institute (across the street from the~          Johns Hopkins Hospital).~      People who are between the ages of 25 and 80 years old, who have a current, regular~     meditation practice, and who meet the medical requirements may join.~   "
120708|NCT01987505|"~     This open-label, single-arm, phase IIIb study will evaluate the safety of switching from~     intravenous (IV) to subcutaneous (SC) administration of MabThera/Rituxan during first-line~     treatment for patients with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large~     B-cell lymphoma (DLBCL) who have already received at least one full dose of MabThera/Rituxan~     IV. Patients with FL will be given 1400 mg MabThera/Rituxan SC during induction therapy (once~     monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). 1400~     mg SC of MabThera/Rituxan will be given to patients with DLBCL once monthly for 4-7 cycles.~     Treatment duration is expected to last up to 7 months for patients with DLBCL and up to 32~     months for patients with FL.~   "
120649|NCT01988298|"~     Hypertensive disorders of pregnancy are a major cause of maternal mortality and morbidity,~     especially in developing countries. Postpartum hypertension can be related to persistence of~     gestational hypertension, preeclampsia, or preexisting chronic hypertension, or it could~     develop de novo secondary to other causes. The available data in the medical literature have~     primarily focused on antenatal and peripartum management. There are few data regarding the~     evaluation in women who are diagnosis with postpartum hypertension. Some medications that~     cause vasoconstriction are often used for pain relief, in women having perineal lacerations,~     episiotomy, or cesarean delivery. Such women usually require large doses of nonsteroidal~     antiinflammatory drugs that are associated with vasoconstriction and sodium and water~     retention, this drugs can result in severe hypertension.~      The purpose of this study is to evaluate maternal postpartum hypertension in women with~     severe preeclampsia treated with nonsteroidal antiinflammatory drugs or acetaminophen.~   "
120650|NCT01988285|"~     Purpose: To validate our previously developed model of risk factors for diagnosis of~     eosinophilic esophagitis (EoE), and to assess the utility of serum levels of biomarkers in~     diagnosis and monitoring of treatment of EoE. Participants: Up to a total of 800 participants~     (approximately 400 with EoE and 400 without EoE) who are referred for upper endoscopy.~     Procedures: This is a prospective cohort study. Patients will be compared with newly~     diagnosed EoE to non-EoE controls, obtain baseline measures, reassess EoE patients after~     treatment, and also reassess untreated controls. Data collection will include questionnaire~     results, blood collection, and tissue collection (esophageal biopsies performed during upper~     endoscopy per pre-specified protocol). Blood will be analyzed for the presence of the~     candidate biomarkers. Patients will be compared with newly diagnosed EoE to non-EoE controls,~     obtain baseline measures, reassess EoE patients after treatment, and also reassess untreated~     controls. Data collection will include questionnaire results, blood collection, possible~     saliva collection, possible urine collection, and tissue collection (esophageal biopsies~     performed during upper endoscopy per pre-specified protocol). Blood will be analyzed for the~     presence of the candidate biomarkers, including eotaxin-3 and IL-13.~   "
120651|NCT01988272|"~     The goal of this study is to develop imaging based methods to accurately determine the energy~     absorbed (absorbed dose) by tumor tissue and bone marrow after radioimmunotherapy with I-131~     tositumomab . The administration of the radioactive, iodine-131 labeled, monoclonal antibody~     I-131 tositumomab, (also known as Bexxar) is part of the patient's clinical treatment~     protocol. For the absorbed dose measurement, investigators at the University of Michigan are~     evaluating a new Nuclear Medicine SPECT/CT imaging system . This new camera combines a CT~     imaging system in addition to a Nuclear Medicine SPECT scanner. CT scans allow the doctors to~     see a high quality picture of your internal organs. The Nuclear Medicine SPECT scanner allows~     the doctors to see the uptake of the radioactive I-131 including the tumor sites. The~     improved imaging using the SPECT/CT enables more accurate calculation of the energy absorbed~     by tumor tissue and bone marrow. Using the results from these calculations and clinical~     follow up data, the researchers will investigate the relationship between the absorbed dose~     to the tumor and the patient's tumor response as well as the relationship between the~     absorbed dose to the bone marrow and the bone marrow toxicity. These relationships can~     potentially be used in the future by doctors to help determine how much radioactive I-131 to~     administer to each patient to get optimal results.~   "
120652|NCT01988259|"~     To proof patients' benefit of minimally invasive surgery in the dorsal cervical spine an~     apparatus to examine head-neck-coordination was constructed.~      Two different surgical techniques will be compared:~      Laminoplasty: open approach vs minimally invasive surgery (MIS)-approach; Foraminotomy: open~     approach vs MIS-approach. Each patient will be tested before surgery, postoperative as well~     as 3 and 12 month follow-up.~      Hypothesis is that patients after MIS-approaches perform better in their~     head-neck-coordination as patients with open approaches.~   "
120653|NCT01988246|"~     To determine the safety and efficacy of intravitreal Aflibercept (Eylea) injection in~     patients with diabetic retinopathy in the prevention of macular edema following cataract~     surgery.~   "
120654|NCT01988233|"~     Investigators propose a randomized controlled trial (RCT) to test the efficacy of the revised~     4-month BAILAMOS© program for improving lifestyle PA and health outcomes (physical and~     cognitive function, self-reported functional limitations, disability) in sedentary older~     Latinos at risk for disability relative to an attention control group.~   "
120655|NCT01988220|"~     Background: It is estimated that 50%-85% of individuals post stroke demonstrate sensory~     deficits. Sensory impairments are often overlooked in the therapeutic setting, although they~     lead to slower motor recovery.~      Working hypothesis: The overall goal of this study is to examine the effectiveness of a~     sensory discrimination reeducation oriented therapeutic program to the lower limb of stroke~     patients with sensory impairments. We assume that subjects to both groups will make progress,~     which will be more significant in the experimental group.~      Methods: Study population and design: Sixty individuals with chronic sensory impairment~     following a stroke will be recruited. Patients will be randomly assigned to sensory~     retraining treatment or to sensory stimulation treatment. Treatment will consist of ten 45~     minute long intervention sessions, carried out within a 6 weeks period, and a home exercise~     program. The person conducting the assessments will be blind to the treatment allocation of~     the subjects. Outcome measures: The efficacy of the intervention will be determined in~     relation to the International Classification of Functionality (ICF) developed by the World~     Health Organization and will include assessments at the three domains defined by this model:~     1. Body structure and function - determined by measures of the sensory capacity of the lower~     more affected limb; 2. Activities - determined by measures of balance and gait; 3.~     Participation - determined by measures of well-being and social reintegration.~      Two new outcome measures, for ankle and knee position sense and for texture discrimination of~     the foot, will be developed within this study. Data reliability measures on healthy~     population, and test - retest measures in post stroke population with be collected.~      Intervention: The experimental group will be treated by a perception learning oriented~     protocol for sensory reeducation, to improve identification, localization and discrimination~     of sensory stimuli, including electrical stimulation, texture and hardness discrimination and~     position sense training. The control group will receive the same stimuli without the~     attentive learning and discriminating component.~      Importance: Scientific proof and focused recommendations for a potent therapeutic method for~     the post-stroke population, allowing them better participation and quality of life.~      Key words: Stroke, sensory impairment, perceptual learning, lower limb, clinical trial.~   "
120753|NCT01986907|"~     The purpose of this study is to evaluate the safety and efficacy of ranibizumab in patients~     affected by wet age related macular degeneration (wAMD).~   "
120871|NCT01985373|"~     Intravenous immunoglobulin (IVIG) is used for treatment of a heterogeneous group of immune~     related disorders both as immune-replacement and immune-modulating therapy. Sanquin developed~     a 100 mg/ml IVIg product (Nanogam 100 mg/ml). Patient will receive one infusion with Nanogam~     50 mg/ml as they used to (same dose) and subsequently 4 infusions with Nanogam 100 mg/ml~     (same dose). Aim is to show bioequivalency between the 50 mg/ml and the 100 mg/ml product of~     Sanquin.~   "
121044|NCT01983111|"~     The purpose of this study is to compare the efficacy and safety of buprenorphine transdermal~     system to tramadol/acetaminophen.~   "
120656|NCT01988207|"~     The purposes of the proposed study are: a) to determine whether Flow Phonation can decrease~     Laryngeal Resistance (Rlaw) in patients with Muscle Tension Dysphonia (MTD); and b)establish~     the relationship between changes in measures of Rlaw and phonatory airflow to endoscopic,~     perceptual, acoustic, and handicap assessment ratings. MTD can have a debilitating effect on~     individuals who rely on their voices the most—teachers, preachers,salespeople,~     singers—costing them time, money, and even their jobs. It can lead to vocal fatigue, pain,~     and complete loss of voice. While treatments have emerged with some promising effects, no~     treatments have proven to have long-term benefits to all patients. Our preliminary data~     demonstrate Flow Phonation training resulted in significant decreases in Laryngeal Resistance~     to phonatory airflow with associated improvements in voice quality and voice handicap~     ratings. Sample size for our pilot study was small; no control group was utilized; and~     outcome measures were limited. In the proposed investigation, a larger sample will be~     obtained, a control group of participants receiving only Vocal Hygiene Training will be used~     for comparison during the first 3 weeks, and a wider range of outcome measures will be~     included over a longer period of time (1 year).~   "
120657|NCT01988194|"~     Many hospitalized patients experience pain during their hospital stay, and less than half~     report adequate pain relief. Common treatments for pain include opioid medications, which~     have associated side effects and complications. Research has shown that acupuncture is~     effective for surgical, postoperative and cancer-related pain, nausea, and vomiting. More~     research is needed on the effectiveness of adding acupuncture to routine care for~     hospitalized patients. The objective of this study is to examine the effectiveness of~     acupuncture delivered in a real-world setting according to the principles of traditional~     Chinese medicine among hospitalized patients to manage pain and other symptoms. 250~     hospitalized participants will be randomized in a 1 to 1 ratio to receive either 1) usual~     care or 2) usual care with acupuncture offered (125 in each group). The primary outcome~     measure will be change in daily pain intensity. Data on other symptoms, such as nausea,~     vomiting, anxiety, and depression, as well as functionality and quality of life will be~     collected in person, on a web-based survey, or via telephone follow-up. The aims of the study~     are to examine the effectiveness of acupuncture to manage pain and other symptoms among~     hospitalized patients; to evaluate the impact of acupuncture on patient satisfaction among~     hospitalized patients; and to estimate costs and cost-effectiveness of acupuncture among a~     subset of hospitalized patients.~      The investigators hypothesize that compared to hospitalized patients receiving usual care~     alone, hospitalized patients receiving acupuncture will have:~        1. decreased pain severity~        2. higher patient satisfaction~   "
120658|NCT01988181|"~     As kidney function declines, the ability to maintain water balance is impaired and is most~     often treated with hemodialysis. The removal of excess water in hemodialysis often leads to a~     sudden drop of blood pressure and causes symptoms of dizziness, light-headedness, cramping,~     and chest pain. This sudden drop in blood pressure has been linked with complications of~     heart attacks, strokes and even death. Research has focused on different ways to prevent~     dangerous drops in blood pressure during hemodialysis. One way is the use of blood volume~     monitoring biofeedback technology to monitor the patient's relative blood volume and~     automatically reduce the amount of fluid that is being removed when the blood volume is low~     to prevent the drop in blood pressure from occurring. This type of biofeedback device is~     currently available on some hemodialysis machines and while this approach appealing, it is~     not clear how effective this form of biofeedback is in preventing the drops in blood~     pressure.~      We plan to determine if the use of biofeedback based on the changes in the patient's blood~     volume will reduce the number of sudden drops in blood pressure that occur during~     hemodialysis. To do this, we will compare patients treated with this technology to current~     hemodialysis practices and follow them for important adverse outcomes. The result of interest~     will be the frequency of hemodialysis sessions complicated by a sudden symptomatic drop in~     blood pressure. We also plan to monitor the amount of water in the different body~     compartments, blood pressure, blood pressure medication use, markers of heart function, and~     patient symptoms and quality of life.~      We hope that by providing information on this technology we can reduce the sudden drops in~     blood pressure in hemodialysis, the associated rates of serious disease or death, and improve~     patient quality of life.~   "
120659|NCT01988168|"~     The purpose of the CSCAR pilot study is to improve the design of a full-scale trial by~     determining the patient recruitment rate and participation rate. The objective of the~     full-scale trial is to determine the optimal method of skin closure after Caesarean delivery~     in women with chorioamnionitis, which is an acute inflammation of the membranes and chorion~     of the placenta, seen typically after rupture of membranes with ascending polymicrobial~     bacterial infection. Women in labour with chorioamnionitis will be randomized at the time of~     Caesarean delivery to skin closure with either staples or sutures. The women will be followed~     at 6 weeks and 6 months post-partum in order to establish the occurrence of surgical site~     infection and wound disruption, as well as evaluation of the scar and other secondary~     questions.~      The investigators hypothesis is that closure of skin with sutures will have a rate of wound~     infection that is no higher than the rate of wound infection when closing skin with staples.~     The investigators also hypothesize that closure with sutures will have a decreased rate of~     wound disruption, increased patient satisfaction and decreased length of hospital stay~     compared to skin closure with staples.~   "
120660|NCT01988155|"~     The purpose of this research study is to determine if Astym® treatment is an effective~     treatment for patients with Achilles pain. The usual treatment for this condition is a~     specific exercise program that has been previously shown to be effective. The research team~     is trying to determine if combining Astym with the exercise program is more effective than~     exercise program only.~      The main hypothesis for this study is that Astym plus eccentric exercise will be more~     effective than eccentric exercise alone at improving pain and function in patients with~     insertional Achilles tendinopathy.~   "
120661|NCT01988142|"~     After spinal cord injury (SCI), the muscular property altered due to the immobilization~     adaptation. The purpose of this study was to investigate the effect of remobilization with~     continuous passive exercise on the adapted paralyzed muscle properties after SCI.~   "
120662|NCT01988129|"~     Firefighters work some of the most demanding schedules known under highly stressful and~     demanding conditions. The need to work frequent extended shifts and long work weeks leads to~     acute and chronic partial sleep deprivation as well as misalignment of circadian phase. Sleep~     disorders are common, costly, and treatable, but often remain undiagnosed and untreated and~     it is likely that a significant proportion of firefighters suffer from undiagnosed sleep~     disorders which will further impair their sleep and exacerbate fatigue.In the current~     proposal, we aim to address the health, performance and safety issues related to fatigue in~     firefighters and test the effectiveness of a Comprehensive Firefighter Fatigue Management~     Program (CFFMP) that we have termed 'Operation Healthy Sleep.'~   "
124925|NCT01932281|"~     The purpose of this study is to examine whether supplementation with SierraSil can improve~     anaerobic power and reduce muscle fatigue in a group of well-trained athletes.~      A secondary purpose is to examine the effect of SierraSil on the severity of delayed onset~     muscle soreness.~   "
120663|NCT01988116|"~     The purpose of the study is to learn more about how treatment with vitamin D can affect iron~     metabolism and blood levels of two hormones that control iron levels, hepcidin and~     hemojuvelin in people with chronic kidney disease (CKD).~      Iron is an essential mineral which is a major component of proteins that carry oxygen in the~     blood. Problems with iron metabolism can lead to low blood levels (anemia), which can~     commonly happen in people with CKD.~      New research over the last decade has uncovered a new hormone called `hepcidin', which is~     made in the liver and released into the blood. Hepcidin controls how much iron is in the~     blood by preventing the absorption of iron from food. Blood levels of hepcidin C are found to~     be high in people with CKD, and a recent small study in people with normal kidney function~     showed that treatment with vitamin D decreased hepcidin levels.~      Another protein, known as `hemojuvelin', has been recently discovered and is also thought to~     control the amount of iron in the blood. The relationship between vitamin D and hemojuvelin~     has never been studied before.~      In this study, investigators would like to examine the effects of vitamin D on iron~     metabolism and blood levels of hepcidin C and hemojuvelin in individuals with CKD.~   "
120664|NCT01988103|"~     This study will test the clinical effectiveness and safety of two orally administered doses~     of apremilast compared to placebo in Japanese patients with moderate-to-severe plaque-type~     psoriasis.~      Apremilast (CC-10004) is a new oral agent that is under clinical development for the~     treatment of inflammatory autoimmune disorders such as psoriasis, psoriatic arthritis,~     ankylosing spondylitis, rheumatoid arthritis, and Behçet disease.~   "
120665|NCT01988090|"~     This study is being done to look at the difference, if there is a difference between two~     different doses of Vitamin D and the reduction of joint/muscle pain (arthralgia)that is~     caused by taking anti-estrogen medications (aromatase inhibitors) by breast cancer patients.~     The investigators hope to learn if taking a higher dose of Vitamin D is a good way to prevent~     aromatase inhibitor arthralgia (AIA).~   "
120666|NCT01988077|"~     A rationally designed combination of adoptive T cell therapy and ipilimumab could strongly~     increase the proportion of CR patients, as well as the durability of response, as compared to~     ipilimumab or TIL alone. The investigators hypothesize that the combination of those two~     important modalities could result in a durable (≥ 1 year) complete response rate of 30% in~     stage IV melanoma patients.~   "
120667|NCT01988064|"~     The aim of this study is to compare the efficacy of group training using a tutorial film and~     one-to-one face-to-face training in calculating the pulse rate and detecting irregularity in~     the pulse rhythm in patients with cardiovascular diseases.~   "
120668|NCT01988038|"~     The design and establishment of the Polycystic Kidney Disease (PKD) Data Repository does not~     require, and may be constrained by, a narrowly conceived hypothesis. However, the PKD~     Repository has been designed to include demographic, clinical, biochemical, and genetic data~     that will further explore the natural history of the disorder and assess the factors that are~     likely to be associated with the progression of disease and the incidence of complications~     including renal failure, cardiovascular disease, and stroke.~   "
120669|NCT01988012|"~     A multi-center, open-label single-arm study to evaluate the efficacy and safety of~     tocilizumab administered as a single, weekly injection in adults with rheumatoid arthritis.~     Combination therapy with methotrexate or other non-biologic disease modifying anti-rheumatic~     drugs (DMARDs) was permitted.~   "
120670|NCT01987999|"~     The purpose of this study is to confirm the findings of an early study with prostate cancer~     and to expand our knowledge of treating prostate cancer using an~     Adenosine-5'-triphosphate(ATP)inhibitor.~   "
120671|NCT01987986|"~     To assess the safety and effectiveness of repeat doses of AA4500 in the treatment of~     edematous fibrosclerotic panniculopathy (EFP) commonly known as cellulite in adult women.~   "
120672|NCT01987973|"~     The investigators hypothesize that the use of an allograft adjuvant to partial repair will~     lead to improved shoulder outcome measure scores compared to partial repair alone in massive~     rotator cuff tears.~   "
120673|NCT01987960|"~     To evaluate the efficacy of brexpiprazole as adjunctive treatment to paroxetine (PAR) or~     sertraline (SER) on PTSD symptoms.~   "
120674|NCT01987947|"~     This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will~     assess the efficacy and safety of additional quilizumab therapy in adult patients with~     Chronic Spontaneous Urticaria resistant to antihistamine treatment.~   "
120675|NCT01987934|"~     Oral cancer represents the sixth most common cancer worldwide whilst in Pakistan it ranks the~     second most common cancer in either gender. Histologically, over 90% of oral cancer lesions~     are squamous cell carcinomas which are diagnosed on the basis of histopathological analysis.~     However, proliferation kinetics and nucleolar status are not clearly delineated by routine~     H&E examination; thus making use of various proliferation markers imperative for the purpose.~      Nuclear organizer regions (AgNORs) are associated with proliferative activity and represents~     as a diagnostic aid in oral malignancies. Similarly, methyl green pyronin (MGP) stain has~     also been valuable as a complement in routine histopathological studies of several neoplastic~     entities.~      Morphometric techniques offer an opportunity to quantify nuclear changes associated with~     malignancy and may provide an objective basis for grading the tumors. The present study is~     planned to analyze the morphometric parameters of the MGP stain in oral squamous cell~     carcinoma, and in their various histological grades, and to assess if the MGP staining~     parameters could give information on the aggressiveness of the malignant lesions of oral~     cavity.~      Sections from thirty cases of squamous cell carcinoma along with thirty cases of normal oral~     mucosa will be evaluated for methyl green pyronin (MGP) and AgNOR staining. Morphometric~     analysis of various MGP staining and AgNOR parameters would be performed using micrometer.~     Statistical analysis of the results will be carried out using SPSS. Quantitative variables~     will be expressed as mean ± Standard Deviation. Frequencies and percentages will be given for~     qualitative variables.~      It is hypothesized that oral squamous cell carcinoma will exhibit significantly higher MGP~     staining and AgNOR staining parameters than normal mucosa of the oral cavity.~   "
120676|NCT01987921|"~     Pediatric acute kidney injury (AKI) is associated with increased morbidity and mortality in~     critically ill patients. Currently, understanding of the epidemiology and diagnosis of AKI in~     children is limited by single center retrospective data and inconsistent diagnostic and~     stratification criteria. The hypotheses of the AWARE study is that 1) renal angina, a~     composite of early injury signs and risk of disease, will predict severe subsequent AKI in~     critically ill children and 2) the incorporation of urinary biomarkers into the renal angina~     scoring system will improve the prediction of the severe injury. The AWARE study is conducted~     to describe AKI epidemiology in a heterogeneous multinational cohort of critically ill~     children, characterize AKI risk factors and associated morbidity, and validate the KDIGO AKI~     criteria as a predictor of pediatric AKI outcomes. The multi-center, multi-national registry~     will create the largest ever repository of information available on AKI in children.~   "
120677|NCT01987908|"~     Sickle cell disease (SCD) is a genetic blood disorder characterized by the presence of~     sickle-shaped red blood cells. In the U.S. and the U.K. this occurs primarily in persons of~     African origin. There is only one drug (hydroxyurea) approved to manage SCD, but it is not~     fully efficacious and can produce medically significant side effects. Aes-103 is being~     evaluated as a novel agent for the long term management of SCD. By directly reducing the~     sickling process, Aes-103 has a different mechanism of action than hydoxyurea. The active~     ingredient in Aes-103 is 5-hydroxymethyl furfural, a naturally occurring small molecule that~     is chemically related to glucose.~      This study will evaluate the safety and pharmacokinetic profile of two dosing regimens of~     Aes-103 for up to 28 days in up to 50 adult subjects with stable SCD compared with subjects~     receiving placebo.~   "
120678|NCT01987895|"~     This clinical study is conducted to assess the efficacy of cadazolid compared to vancomycin~     in subjects with Clostridium difficile-associated diarrhea (CDAD).~   "
120679|NCT01987882|"~     The primary purpose of the project is to evaluate the effectiveness of different intervention~     strategies to prevent or relieve symptoms associated with hip instability in children with~     severe cerebral palsy, using the validated Caregiver Priorities and Child Health Index of~     Life with Disabilities (CPCHILD©) questionnaire as the primary outcome measure of~     health-related quality of life for this population.~   "
120680|NCT01987869|"~     Serotonin excretion was investigated in the nausea and vomiting associated with hiperemezis~     gravid arum.~   "
120681|NCT01987856|"~     Single embryo transfer (SET) has been advocated as a means of reducing the risk of multiple~     pregnancies, but has meant a reduction in pregnancy risk per embryo transfer. Embryo~     aneuploidy has been cited as the primary reason for the low embryo implantation achieved in~     human IVF. In the majority of IVF programs embryo selection has mainly been based on the~     microscopic assessments embryo. Culturing embryos to the blastocyst stage as a selection~     mechanism has seen an increase in implantation rates, presumably indicating that~     morphologically normal blastocysts formed by day 5 of culture may have a reduced aneuploidy~     rate. Morphological normality does, however, not completely preclude aneuploidy, with many~     transferred and cryopreserved embryo bearing factors that may hold an increased risk for~     implantation failure and miscarriage.~      To select the conditions for single blastocyst transfer that will significantly improve~     reproductive outcomes; increased implantation, reduced pregnancy loss and increased live~     birth rates.~   "
120682|NCT01987843|"~     The primary objectives of the study are:~        -  To evaluate the safety and tolerability of three dose levels of MT-1303 in subjects with~          moderate to severe chronic plaque psoriasis.~        -  To evaluate the efficacy of three doses levels of MT-1303 in subjects with moderate to~          severe chronic plaque psoriasis compared to placebo after 16 weeks of treatment on~          Psoriasis Area and Severity Index (PASI).~   "
120683|NCT01987830|"~     This research study is exploring how the blood vessels in the participant's tumor change from~     treatment with bevacizumab, and how these changes affect the way their tumor absorbs~     temozolomide (TMZ).~      The pilot part of this study is to evaluate the use of [11C] temozolomide PET (TMZ-PET) scans~     and MRI scans to tell investigators more about how standard treatment with bevacizumab~     affects the blood vessels in the participant's tumor, and how these changes affect the way~     the participant's tumor absorbs temozolomide. Investigational means that the role of~     TMZ-PET scans is still being studied and that research doctors are trying to find out more~     about it.~      Bevacizumab is approved by the U.S. Food and Drug Administration for use in people with the~     participant's type of cancer. It works by blocking signals on a specific protein called~     vascular endothelial growth hormone (VEGF), which plays a role in promoting the growth of~     spread of tumor blood vessels. Bevacizumab is an anti-VEGF' agent because it is designed to~     slow the growth of the participant's cancer.~      Since anti-VEGF agents also affect normal blood vessels in the brain, they can inhibit the~     way other drugs used in combination with bevacizumab are delivered to the tumor. Researchers~     are looking for how bevacizumab affects delivery of chemotherapy, in this case temozolomide.~      In PET scans, a radioactive substance is injected into the body. The scanning machine finds~     the radioactive substance, which tends to go to cancer cells.~      For the PET scans in this research study, the investigators are using a radioactive substance~     called [11C] temozolomide, which is chemically identical to the prescription drug TMZ. TMZ is~     FDA approved as a chemotherapeutic agent in cancer but [11C] temozolomide is an~     investigational agent.~      In this research study, participants will receive standard treatment with bevacizumab and~     oral temozolomide as well as standard MRI scans. In addition, participants will undergo~     TMZ-PET scans before and after treatment with bevacizumab. The first TMZ-PET scan will occur~     7-13 days after starting treatment with oral temozolomide but before beginning treatment with~     bevacizumab, day 1 after starting treatment with bevacizumab and 1 month after starting~     bevacizumab. TMZ-PET scans will be given at the same time as a vascular MRI, which will~     evaluate the changes in tumor blood flow, blood volume, and how receptive blood vessels are~     while also measuring how much TMZ is in the brain.~   "
120684|NCT01987817|"~     This is a multi-center, randomized, double-blind placebo controlled study of efficacy and~     safety of characterized peanut oral immunotherapy in peanut allergic individuals.~   "
120685|NCT01987804|"~     Up to 50% of all postmenopausal women, experience vaginal drynes, i.e. vaginal atrophy is a~     consequence due to the lack of estrogen. In addition, vaginal atrophy is associated with an~     increased pH, which creates an environment more susceptible to infections . The mucosal~     epithelium shows signs of severe senile atrophy and cytological examination demonstrate~     increased number of the basal and parabasal cells and reduced number of superficial cells .~     Unlike some other menopausal symptoms (for instance hot flushes), vaginal symptoms generally~     persist or worsen with aging.Oxytocin is a peptide hormone and it is released systemically~     via the posterior pituitary. The most well known effects of oxytocin are its roles in female~     reproduction such as facilitation of birth and breast feeding. Oxytocin has also shown to~     exert positive effects on the proliferation of human vaginal mucosal cells from~     postmenopausal women, an effect which could be attributed either to the direct stimulation of~     new cell formation or to an increased production of other growth factors. The primary~     objective is to investigate the dose relationsship of topical administrated Vagitocin on the~     vaginal mucosal membrane, measured in the change (%)of superficial cells up to 7 weeks after~     baseline.~   "
120686|NCT01987791|"~     To compare the safety and efficacy of 12 months of low dose prednisone with low dose~     cyclosporine combined with entecavir in patients with thrombocytopenia associated with~     HBV-related cirrhosis.~   "
120699|NCT01987622|"~     Acupuncture is widely used to manage chronic low back pain. Mounting evidence suggests the~     beneficial effects of acupuncture for mitigating chronic low back pain with acceptable minor~     adverse events. However, little information exists regarding the effects and safety of~     acupuncture for degenerative lumbar spinal stenosis, one of the spinal disorders that present~     chronic low back and leg pain.~      The investigators aimed to assess the overall effectiveness, safety, and feasibility of~     acupuncture in combination with usual care (as opposed to usual care alone) for patients with~     symptomatic degenerative lumbar spinal stenosis.~      The hypotheses of this study are as follows:~        1. A set of acupuncture sessions in combination with usual care can provide greater~          functional improvements than usual care alone .~        2. A set of acupuncture sessions in combination with usual care can provide greater pain~          reduction than usual care alone .~      The study aims to include 50 participants (25 in the acupuncture group and 25 in the usual~     care group).~   "
120687|NCT01987778|"~     Today's women will live more than a third of their lives after menopause, i.e. with a changed~     hormonal and metabolic state. Vasomotor symptoms like hot flushes and sweating are reported~     by about 75% of all women around menopause and may impair well-being, mental state, daily~     activities and night sleep. Vasomotor symptoms are less prevalent in women who participate in~     regular physical exercise. It is, however, still uncertain if physical exercise reduces~     vasomotor symptoms.~      The purpose of this randomized controlled study is to establish possible beneficial health~     effects from 15 weeks of supervised resistance training (RT) on postmenopausal women.~     End-points include effects from RT in postmenopausal women on~        1. clinical outcomes (number and severity of vasomotor symptoms, Health-Related quality of~          Life (HRQoL), Body Mass Index (BMI), abdominal height, muscle strength and mass,~          browning of fat),~        2. diagnostic variables (production of myokines as irisin, immunological markers) and~        3. genetic variables (length of telomeres).~      The control group will be offered resistance training after the intervention period.~   "
120688|NCT01987765|"~     This study is a Post-Marketing Surveillance study in Korea to evaluate the safety and~     efficacy of Relestat Ophthalmic Solution 0.05% in patients with allergic conjunctivitis who~     are treated with Relestat as standard of care in clinical practice.~   "
120689|NCT01987752|"~     This study is a Post-Marketing Surveillance study in Korea to evaluate the safety and~     efficacy of Combigan® (brimonidine tartrate/timolol maleate) Ophthalmic Solution in patients~     with Open Angle Glaucoma or Ocular hypertension with insufficient response to local beta~     blockers treated as per standard of care in clinical practice.~   "
120690|NCT01987739|"~     This was a six-way crossover study with six single-dose treatment sessions. The profile of~     acute effects on abuse potential measures of different almorexant doses was compared to that~     of placebo and two doses of zolpidem~   "
120691|NCT01987726|"~     This pilot clinical trial studies comprehensive gene sequencing in guiding treatment~     recommendations in patients with metastatic or recurrent solid tumors. Studying samples of~     blood and tissue from patients with cancer in the laboratory may improve the ability to plan~     treatment.~   "
120692|NCT01987713|"~     Methods: This study will be a three-year mixed methods study, including the identification of~     obesity issues among children with chronic conditions in the first phase study~     (2013/10/01-2014/07/31), development of an intervention protocol in the second phase study~     (2014/08/01-2015/07/31), and conduction/evaluation of an intervention of lifestyle~     intervention in the third phase study (2015/08/01-2016/07/31). Firstly, anthropometry,~     healthy lifestyles questionnaire survey on children aged 7-12 and school environment audit~     will be conducted. By using the literature review, meta-analysis and focus-research~     approaches to develop a healthy lifestyle intervention protocol in the second year program.~     The protocol will be tested on a sample of school-age children with asthma, to develop a~     school-based and family-involved healthy lifestyle intervention. Finally, the protocol will~     be undertaken on children with asthma aged 10-15, by using an experimental (pretest-posttest)~     design with repeated follow-ups. The research subjects will be randomly assign to condition~     of receiving intervention or control; the measurement of the outcome across 4 observations,~     to assess both group differences (experimental comparison), and changes within groups. The~     interventions consist of healthy diet (X1), regular exercise (X2), and booster energy~     balance-related behaviors (BEBRB) (X3). The observations start from baseline (O1), then have~     three observations (O2, O3, O4) at 3-month interval respectively. Outcome indicators include~     height, body weight, waist circumference as well as healthy life style modification present~     by diet record, exercise diary, healthy life environments. The research subjects will consist~     of randomly sampled school-age children and their fathers (or mothers), school teachers and~     school nurses. The approximate sample size is estimated by power analysis and dropout rate,~     the eligible sample size will be 200 and 160 pairs of children with their parents, school~     teachers and nurses in the first and third year respectively.~   "
120693|NCT01987700|"~     The primary objective of this study is to examine and compare the outcomes associated with~     the use of Flex HD®, a human acellular dermal matrix (HADM), and Strattice™, a porcine~     acellular dermal matrix, (PADM) when used as a reinforcing material in the repair of large~     complicated abdominal wall hernias.~   "
120694|NCT01987687|"~     Postprandial glycaemic control is an important risk factor for the development of type 2~     diabetes, cardiovascular disease and all-cause mortality.~      Previous research has demonstrated that exercise performed in the postprandial state~     paradoxically results in a deterioration in glucose tolerance in the immediate post-exercise~     period (Gonzalez et a. 2013; Gonzalez and Stevenson 2013). This study aims to assess the~     timecourse of this post-exercise effect.~   "
120695|NCT01987674|"~     The purpose of this study is to investigate if a pre-meal drink containing proteins can~     positively influence glycaemic control in patients with type 2 diabetes mellitus. Comparison~     with a placebo is included.~   "
120696|NCT01987661|"~     15 COPD patients will be surveyed in this prospective randomized crossover pilot study~     concerning non invasive ventilation. Patients will be treated over 2 nights in randomized~     order with Ventimotion2 (Weinmann) with and without Airtrap Control under Polysomnography~     (PSG) surveillance including transcutaneous pCO2 measurement. The sleep quality is judged by~     evaluating the PSG and pCO2 values over night.~      Target parameters are respiratory rate, sleep quality and influence of Airtrap Control on~     pCO2 values over night.~   "
120697|NCT01987648|"~     Regarding the postoperative care strategies following elective craniotomy procedures there is~     little evidence. Many neurosurgical departments prefer these patients to remain intubated and~     sedated for many hours postoperatively to minimize hemodynamic and respiratory distress in~     fear of early postoperative complications such as rebleeding or seizures. In this prospective~     observational study the investigators aim to show that early tracheal extubation following~     elective brain surgery is feasible and safe.~   "
120698|NCT01987635|"~     Mitral valve reconstruction commonly requires the use of an anuloplasty device to assure~     long-term durability of the repair. Among mitral anuloplasty devices, varying from rigid to~     complete flexible ring substitutes, the most recent ones are aimed to restore the natural~     saddle shape of the mitral annulus, in order to decrease the stress tension on both mitral~     leaflets and chordal attachments. So far, even for flexible ring devices, the sustained~     flexibility of the device remained unproven, probably by cicatricial fibrotic tissue ingrowth~     after implantation.~      Due to specific structural characteristics based on a nitinolstent with carbofilm-coating,~     the MEMO 3D ring device of SORIN claims preservation of the ring flexibility during the~     cardiac cyclus. Consequently, mitral anuloplasty with this device is expected to decrease the~     stress during the systolo-diastolic movements of the valve, and so, improve the late~     durability of the repair.~      Echocardiography is the first-line technique for mitral valve assessment after surgical~     repair, for both intra-operative evaluation and serial follow-up of valve function. Recently,~     three-dimensional echocardiography has been introduced into clinical practice, affording~     qualitative and quantitative measurement of mitral valve function and size during the cardiac~     cycle.This method allows to quantify precisely the excursion of the mitral annulus between~     systole and diastole.~      The aim of this study is to analyse the systolo-diastolic movement of the mitral annulus~     after the use of an anuloplasty with the SORIN MEMO 3D device, after surgical implantation~     and its sustainability, 1 year after implantation.~      This hypothesis is tested in a case-controlled comparison with a standard used rigid ring~     device.~      Therefore, 3-D echocardiography will be performed at the time of surgical repair, and after 1~     year, to define the size and surface change of the mitral anuloplasty device during the~     cardiac cycle.~      Based on a sample size calculation, 10 patients in each comparison group will be included,~     suggesting a study cohort of 20 patients eligible for mitral valve repair.~   "
120700|NCT01987609|"~     Dendritic cells are a key component of the inflammatory response seen in psoriasis. Several~     current psoriasis therapies have been shown to reduce the number of dendritic cells in~     patients with psoriasis, leading researchers to believe that therapies specifically targeting~     dendritic cells may lead to improvement in psoriasis. Research recently conducted in Dr.~     Gallo's lab at the University of California San Diego has shown that transgenic mice~     overexpressing the enzyme hyaluronidase have a significant decrease in the number of~     dendritic cells in the dermal component of their skin compared to wild type mice. If~     hyaluronidase overexpression in humans also decreases the number of dendritic cells in the~     dermis, then hyaluronidase therapy may improve the clinical presentation of psoriasis. In~     order to test this hypothesis, recombinant human hyaluronidase (Hylenex®) will be injected~     subcutaneously below a psoriatic plaque in human psoriasis patients every week for a total of~     4 weeks. Each week the clinical appearance of the plaque will be documented. At the final~     visit skin biopsies of the treated plaque will be taken to visualize the histology of the~     plaque and look for changes in expression of different inflammatory markers.~   "
120701|NCT01987596|"~     This randomized phase III trial studies flexible administration of filgrastim after~     combination chemotherapy to see how well it works compared to fixed administration of~     filgrastim in decreasing side effects of chemotherapy in younger patients with cancer. Cancer~     chemotherapy frequently results in neutropenia (low blood counts) when patients are~     susceptible to severe infections. A medicine called G-CSF (filgrastim) stimulates bone marrow~     and daily filgrastim shots are commonly used to shorten neutropenic periods and decrease~     infections after chemotherapy. Since filgrastim is customarily used on a fixed schedule~     starting early after chemotherapy and there are data that early doses may not be needed, this~     study tests new flexible schedule of filgrastim to optimize its use by reducing the number of~     painful shots, cost of treatment, and filgrastim side effects in children with cancer~     receiving chemotherapy.~   "
120702|NCT01987583|"~     This research proposal is submitted to fulfill the requirement of the PHD degree of Community~     Medicine Saudi Board at the Joint Program of Family and Community Medicine in Jeddah, Saudi~     Arabia.~      Background: Cupping is an ancient treatment remedy that has been used for many centuries in~     many parts of the world. In the Middle East, Wet cupping Hijama is still a popular~     treatment because of its religious background. Despite of that, it still has little~     scientific evidence that proves its efficacy. Many hijama healers claim that they have~     observed dramatic improvement in Blood pressure control of hypertension patients. Not many~     studies support that. This study should help to prove or disprove this hypothesis.~      Objectives:~        -  To determine the efficacy of wet cupping on blood pressure among high blood pressure~          patients.~        -  To assess the incidence of wet cupping side effects in the intervention group.~      Methods: The study design is a randomised controlled trial. There will be an intervention~     group of high blood pressure patients who will perform hijama in addition to their usual~     management, and a control group of high blood pressure patients who will receive their usual~     anti-hypertension management only. There will be 8 weeks follow up period. After that, data~     entry, analysis and interpretation will take place.~      Hypothesis: Wet cupping has an effect on blood pressure in adult hypertension patients~   "
120703|NCT01987570|"~     Generating critical levels of power is a prerequisite for performing simple daily activities,~     such as rising from a chair or climbing stairs. For a young healthy person these activities~     can be performed easily, however after a prolonged period of forced inactivity (such as~     during the recovery from a sports injury, prolonged bed rest or spaceflight) a loss of muscle~     mass occurs. It has been suggested that this loss may be triggered by oxidative stress. An~     enzyme involved in the production of free radicals in various experimental models, including~     immobilization, is xanthine oxidase (XO). Although allopurinol is an inhibitor of XO widely~     used in clinical practice, its effect on the maintenance of muscle mass after an~     immobilization protocol is unknown. Thus, the major aim of this clinical trial is to~     determine the effect of allopurinol administration on the prevention of muscle mass loss in~     immobilized subjects.~      This is a prospective, randomized study in which fifty young male subjects (aged between 25~     and 40 years) diagnosed with grade II ankle sprain will be recruited. After immobilization~     the patients will be assigned randomly to one of two experimental groups, one treated with~     allopurinol (n=25) and the other with placebo (n=25). The dosage of allopurinol will be the~     same as recommended for gout patients, i.e. 300 mg/day orally, during all the immobilization~     period, which will last fifteen days. This medication will be delivered to the patients when~     they agree to participate in the clinical trial. They will be immobilized by posterior knee~     splint, preventing use of that leg.~      We will determine muscle mass loss by performing two magnetic resonances of both legs before~     and after the immobilization period. We will also take two blood samples (before and after~     immobilization) to measure oxidative stress parameters (malondialdehyde, protein carbonyls,~     and XO activity), inflammatory parameters (IL-6, C-reactive protein and 1-antichymotrypsin),~     as well as vitamin D levels.~   "
120704|NCT01987557|"~     Treadmill training has been shown to be beneficial for reducing motor symptoms of Parkinson's~     disease (PD). The mechanisms for the therapeutic effects of treadmill training remain~     unknown. However, specific types of intrinsic feedback generated from muscle spindles (detect~     changes in length of muscle) and golgi tendon organs (detect muscle force) seem to be an~     important factor for achieving the reductions in motor scores. This study will compare a~     treadmill program that generates a high rate of intrinsic feedback to a treadmill program~     focused on generating a high magnitude of intrinsic feedback.~   "
120705|NCT01987544|"~     Home ergometer training combined with online monitoring and regular telephone support could~     prove to be a cost-effective method to improve physical performance and quality of life in~     COPD patients.~      The primary objective of the study is to demonstrate a significantly higher daily workout~     time in patients that are monitored during home ergometer training with telephone support~     compared to conventional home ergometer training. Consequently we expect an increased quality~     of life related to the illness and a decreasing BODE-Index. A post-interventional lower~     BODE-Index correlates with a reduced risk of hospitalisation and mortality.~   "
120706|NCT01987531|"~     The hypothesis of this study is that temporary biventricular pacing will improve hemodynamic~     performance in patients with right ventricular dysfunction after open cardiac chamber cardiac~     surgery.~   "
120707|NCT01987518|"~     French cohorte about polyposis digestive diseases~   "
120754|NCT01986894|"~     This is a single-center, randomized, double-blind crossover study with four treatments, four~     periods and four sequences to investigate the effects of orally administered pomalidomide on~     QT interval. The study will be conducted in healthy male subjects. Pomalidomide (clinically~     indicated dose for multiple myeloma [MM] as per the United States Package Insert [USPI] of 4~     mg and supratherapeutic dose of 20 mg) and placebo treatments will be double-blinded.~     Moxifloxacin (positive control) will be administered in an open-label fashion to determine~     the sensitivity of the assay. The core electrocardiogram (ECG) laboratory and ECG readers~     will be blinded to all study treatments and sequences.~   "
120709|NCT01987492|"~     This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will~     evaluate the efficacy of lebrikizumab compared with placebo, as measured by the ability of~     participants to achieve lower daily doses of OCS, among those with severe~     corticosteroid-dependent asthma. Prednisone/prednisolone will be the OCS therapy prescribed.~     Participants will be randomized to receive lebrikizumab or matching placebo for 44 weeks in a~     double-blind, placebo-controlled (DBPC) period. Those who complete the 44-week period may~     continue into a 32-week active treatment extension (ATE) period, during which all~     participants will receive lebrikizumab treatment. Following completion of the ATE period,~     participants who have both tolerated and derived benefit from treatment with lebrikizumab may~     continue their lebrikizumab treatment into a long-term extension (LTE) period. Participants~     will transition to 24 weeks of safety follow-up upon discontinuation of study drug.~   "
120710|NCT01987479|"~     This multi-center, open-label single arm Phase IIIb study will evaluate the safety and~     efficacy of subcutaneous (SC) tocilizumab administered as monotherapy and/or in combination~     with methotrexate or other non-biologic disease modifying antirheumatic drugs (DMARDs) in~     participants with rheumatoid arthritis (RA) with an inadequate response to non-biologic~     DMARDs.~   "
120711|NCT01987466|"~     Postresuscitation disease is a constellation of disorders related to whole-body ischemia and~     reperfusion syndrome. It includes hypoxic damage in brain, liver, kidney, heart and other~     organ. In previous study more than one-third of patients resuscitation from out of hospital~     cardiac arrest developed renal dysfunction. In acute kidney injury, NGAL is an earlier marker~     compared with serum creatinine.~      Cardiac arrest and severe asphyxia result in global brain ischemia. In previous study serum~     NGAL correlated with hypoxic ischemic encephalopathy in asphyxiated neonate.~      This study was designed to assess serum NGAL level in postresuscitative patients to evaluate~     its relation to hypoxic brain injury severity, and its clinical utility for early detection~     of acute kidney injury in these patients.~   "
120712|NCT01987453|"~     The primary objectives of this study are to evaluate the efficacy, safety, and tolerability~     of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin~     (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV) infection who have~     participated in a prior Gilead-sponsored HCV treatment study, and who did not achieve~     sustained virologic response (SVR24), defined as HCV RNA < lower limit of quantification~     (LLOQ) 24 weeks after last dose of study drug (SVR24).~   "
120713|NCT01987440|"~     Pelvic examination, an important part of gynecologic oncology patients to help detect cancers~     recurrence or infections.Despite its importance, many women are reluctant and anxious about~     the procedure because of fear, as well as discomfort and pain. The objective of this study is~     to estimate whether using lubricating gel decreases patient pain during speculum insertion~     compared with using water in gynecologic oncology patients~   "
120714|NCT01987427|"~     APD356-A001-402 is a multicenter, double-blind, randomized, parallel-group pilot study of~     12-week duration in overweight and obese adults. Approximately 225 subjects will be~     randomized to one of three treatment arms in a ratio 1:1:1 and will receive the combinations~     of lorcaserin 10 mg twice daily (BID) plus immediate-release phentermine-HCl 15 mg BID or 15~     mg once daily (QD), or lorcaserin alone.~   "
120715|NCT01987414|"~     The purpose of this study is to examine the efficacy of a forearm rotation orthosis combined~     with the occupational therapy task-oriented approach on functional performance for persons~     with a hemiparetic arm.~      Hypotheses of this study are:~        1. participants who wear the forearm rotation orthosis will demonstrate significantly~          greater improvement in functional performance and active range of motion of forearm~          rotators compared to those who do not;~        2. all participants who receive the occupational therapy task-oriented approach~          intervention will demonstrate significant improvement in functional performance; and~        3. all participants who receive the occupational therapy task-oriented approach~          intervention will demonstrate improvement in motor function of the upper extremity.~   "
120716|NCT01987401|"~     The primary objective of CSP #595, Service and Health During the Iraq and Afghanistan Era,~     is to characterize the impact of deployment to Iraq and Afghanistan on the respiratory health~     of Veterans. The purpose of the pilot study is to determine the willingness of Veterans who~     served during the Iraq and Afghanistan Era to provide health and military service~     information. This information will help us design a larger national study.~   "
120717|NCT01987388|"~     The objective is to develop a new metabolic flexibility biomarker, which has application in~     the study of changes diet and exercise on fuel management in humans. The new biomarker~     involves the characterization of an individual's metabolic flexibility utilizing room~     calorimeters rather than the current method, which is based on glucose clamp data. It is~     hypothesized that this new metabolic flexibility method will be a useful and noninvasive~     biomarker for measuring adaptation to exercise and diet challenges.~   "
120718|NCT01987375|"~     This study is an open label, single institution, Phase 1 dose-escalation study to determine~     the safety profile of cetuximab-IRDye800 used in subjects with head and neck squamous cell~     carcinoma (HNSCC) that undergo surgery with curative intent. Participants will be given a~     dose of an approved head and neck cancer drug (Cetuximab) along with an investigational study~     drug called Cetuximab-IRDye800. Cetuximab-IRDye800 is a drug that is given prior to surgery~     that attaches to cancer cells and appears to make them visible to the doctor when he uses a~     special camera during the operation. The investigators are evaluating whether or not the use~     of the study drug along with the special camera will better identify the cancer while~     patients are in the operating room.~   "
120755|NCT01986881|"~     A study of the cardiovascular outcomes following treatment with ertugliflozin in participants~     with type 2 diabetes mellitus (T2DM) and established vascular disease. The main objective of~     this study is to assess the cardiovascular safety of ertugliflozin. This trial includes a~     pre-defined glycemic sub-study in participants receiving background insulin with or without~     metformin, a pre-defined glycemic sub-study in participants receiving background sulfonylurea~     monotherapy, and a pre-defined sub-study in participants receiving background metformin with~     sulfonylurea (all fully-enrolled).~   "
121570|NCT01976234|"~     Transfusion of RBC is associated with post operative infections. Our hypothesis is that~     stored blood could be related with increased post operative infection risk. Surgical patients~     transfused during the operation or immediately after will be included in our study. Patients~     will receive fresh or old blood during the whole recovery.~   "
120719|NCT01987362|"~     This is a Phase 1, non-randomized, dose-escalating, open label, multi-center study to be~     conducted in two parts (Part A and Part B). RO6870810 is a small molecule, non-covalent~     inhibitor of bromodomain and extra-terminal (BET) family of bromodomains. This study is~     designed to characterize the safety, tolerability, pharmacokinetics and anti-tumor activity~     of RO6870810 in participants with histologically confirmed solid tumors with progressive~     disease (PD) which is refractory or intolerant to standard/approved therapies. In Part A,~     RO6870810 will be administered by subcutaneous (SC) injection daily for either 21 consecutive~     days in a 28-day cycle or for 14 consecutive days in a 21-day treatment cycle in participants~     with advanced solid tumor malignancies to determine the maximum tolerated dose (MTD) and~     dose-limiting toxicities (DLT). In Part B, RO6870810 will be administered at a dose up to the~     MTD to further characterize the safety profile and biological effect in a subset of~     participants with advanced solid tumor malignancies. It is anticipated that a total of 84~     participants will be enrolled in to this study (54 in Part A and 30 in Part B). In addition,~     it is expected that up to 20 participants with histologically confirmed nuclear protein in~     testis (NUT)-midline carcinoma (NMC) with progressive disease requiring therapy will be~     enrolled in the sub-study of Parts A and B. In addition, up to 20 participants with diffuse~     large B-cell lymphoma (DLBCL) may be enrolled at selected study sites.~   "
120720|NCT01987349|"~     This study will compare influenza vaccine responses in monozygotic and dizygotic twins.~   "
120721|NCT01987336|"~     To analyze biofilm obtained from at least 10 Subjects who have an indwelling catheter. A 30cc~     urine sample would also be collected from the same subject, and analyzed.~   "
120722|NCT01987323|"~     Aim: Evaluation of a single subconjunctival injection of liposomal EggPC formulation of~     latanoprost in treating glaucoma.~      Hypothesis: The investigators have already evaluated carrier stability, drug partitioning, in~     vitro drug release, tolerance, and efficacy of latanoprost-incorporated EggPC liposomes upon~     subconjunctival administration in both rabbit and monkey eyes. Therefore, the investigators~     hypothesize that this would be safe and efficacious in humans as well.~      Methodology: A pilot study to assess a liposome formulation containing latanoprost. The~     investigators will recruit 6 study subjects with eyes that have raised IOP, for~     subconjunctival injection of this liposome formulation. The recruited eye will be injected~     and monitored for inflammation, toxicity and pain as primary end-points. Monitoring of the~     eye will be for the first 24 hours post-injection, week 2, months 1, 2 and 3 thereafter.~      Importance: If proven safe, this method of drug delivery could potentially be used for~     treatment of raised intraocular pressures in blinding conditions such as glaucoma.~   "
120723|NCT01987310|"~     The aim of the current study is to evaluate the association of fatty liver severity and~     endothelial function in Non-Alcoholic Fatty Liver Disease (NAFLD) patients and to find the~     impact of statin treatment compared to usual care or life style modification on endothelial~     function, liver steatosis and fibrosis.~   "
120724|NCT01987297|"~     In this prospective randomized study for patients with newly diagnosed acute promyelocytic~     leukemia, patients will be randomized into two groups which received retinoic acid and~     arsenic trioxide based treatment versus retinoic acid and chemotherapy based regimen.~   "
120725|NCT01987284|"~     Isolated Systolic Hypertension (ISH)is the dominating hypertensive disease in elderly people.~     Much attention has recently been drawn to the strong relationship between the systolic blood~     pressure and cardiovascular morbidity.~      In previous clinical studies carried out in individuals with normal blood pressure at~     baseline SER100 decreased primarily the systolic blood pressure. It is hypothesized that the~     effect on systolic blood pressure in hypertensive patients will be larger or equal to the~     fall seen in normotensive patients.~   "
120726|NCT01987271|"~     The purpose of this study is to evaluate the effect of noninvasive ventilation (NIV) in~     functional capacity of children and adolescents with cystic fibrosis.~   "
120727|NCT01987258|"~     Four months of interval walking training (IWT) is superior to energy-expenditure matched~     continuous walking training (CWT) with regards to weight loss and improvements in glycemic~     control. The reason for this is unclear. One potential explanation for the differential~     outcome in weight loss is excess post-exercise oxygen consumption (EPOC), which is defined as~     the elevated oxygen consumption measured during the hours following an exercise bout. A large~     EPOC means greater energy expenditure which, if energy intake does not change, leads to a~     greater weight loss. This weight loss may subsequently improve glycemic control~        -  Aim 1: To assess the effect of an acute bout of IWT vs. an acute bout of CWT on glycemic~          control in type 2 diabetics and to assess mechanisms responsible for differences (if~          any). It is hypothesised that IWT will be more advantageous for improving glycemic~          control.~        -  Aim 2: To examine the effect of an acute bout of IWT vs. an acute bout of CWT on EPOC.~          It is hypothesised that IWT will produce an EPOC of larger magnitude than CWT.~   "
120728|NCT01987245|"~     Cardiopulmonary resuscitation(CPR) is the key to success for high-quality early~     cardiopulmonary resuscitation, and its success in the restoration of spontaneous circulation~     (ROSC), therefore, monitoring the quality of cardiopulmonary resuscitation and early~     identification ROSC is very important. Now there is no an easy, non-invasive and real-time~     method to monitor the quality of CPR. In this study the investigators hypothesis the pulse~     oximeter waveform can real-time monitor the quality of CPR ,and feedback the quality of CPR~     to the physicians.~   "
120729|NCT01987232|"~     The purpose of this study is to determine the maximum tolerated dose and assess the safety,~     tolerability and activity of carfilzomib given in combination with carboplatin and etoposide~     as initial therapy for patients with extensive-stage small-cell lung cancer (ES SCLC).~   "
120756|NCT01986868|"~     This is a pilot study to determine whether coronary magnetic resonance angiography(CMRA)can~     identify adverse plaque characteristics (buildup of fat, cholesterol, calcium, and other~     substances found in the blood) seen on coronary computed tomography angiography(CCTA) and~     evaluate whether there is a relationship between the adverse plaque characteristics and the~     presence of coronary artery wall inflammation.~   "
121131|NCT01981967|"~     The aim of this study is to further characterize the safety profile of IMOJEV®.~      Primary Objective:~        -  To describe serious adverse events (SAEs, including adverse events of special interest~          [AESIs]) up to 60 days after administration of one dose of IMOJEV®.~      Secondary Objective:~        -  To describe Grade 3 (severe) systemic Adverse Events (AEs) up to 30 minutes after~          administration of one dose of IMOJEV®.~   "
120730|NCT01987219|"~     Evaluate the effects of bronchodilator therapy on respiratory function. Our overall goal is~     to determine whether, in patients with familial dysautonomia (FD), there is a component of~     airway obstruction that is reversible. To this end, we will evaluate airway resistance before~     and after receiving the anti-cholinergic ipratropium (Atrovent ®) and the beta-2-agonist~     albuterol (ProVentil®/Ventolin®). We predict that the response to either drug will depend on~     the underlying level of sympathetic and parasympathetic activity and airway tone. We will~     then determine the cardiovascular effects of inhaled ipratropium and albuterol in patients~     with FD. Because patients with FD have fewer sympathetic neurons and denervation~     supersenstivity, we predict that following albuterol inhalation, there will be non-selective~     activation of alpha-1-adrenergic receptors. Furthermore, because of a congenital defect in~     the afferent baroreceptor neurons that sense blood pressure, we suspect that the resulting~     vasoconstriction will be unopposed leading to a pressor effect. We hypothesize that~     inhalation of the anti-cholinergic ipratopium will produce little rise in heart rate, due to~     the extent of parasympathetic denervation to the heart.~   "
120731|NCT01987206|"~     The goal of this proposed study is to explore the feasibility of using a PID~     (Proportional-Integral-Derivative) controller versus an MPC (Model Predictive Control)~     controller algorithm in an artificial pancreas system, all other components and study design~     being equal.~      The study consists of an evaluation of either type of control algorithm as a part of the~     Artificial Pancreas (AP) device during two periods of 27.5-hour closed-loop control in a~     clinic environment (Sansum Diabetes Research Institute, Santa Barbara, CA) separated by a~     minimum of 5 days and a maximum of 2 weeks. The 27.5-hour period includes: 2 announced meals~     (dinner and breakfast of 65g and 50g CHO respectively) preceded with a dose of rapid-acting~     insulin equivalent to 100% bolus based on each subject's Insulin to Carbohydrate (I:C) ratio~     and 1 unannounced meal (lunch of 65g carbohydrates, same meal content as dinner); complete~     night from 12:00 am to 7:00 am. The goal is to demonstrate that the AP device is able to~     maintain the subject blood glucose within a safe range at all times.~   "
120732|NCT01987193|"~     The purpose of this study is the development of noninvasive (having no direct contact)~     detector and electronic system that will directly measure tumor blood flow rate.~   "
120733|NCT01987180|"~     The goal of this research is to develop and pilot the NICU-2-Home service, a health~     information technology (IT) concept centered on a smart phone app. NICU-2-Home will provide~     support to parents of very low birth weight (VLBW) infants as they transition from the NICU~     to their homes and eventually establish a medical home with the infant's pediatrician. Once~     the app is developed, we will conduct a feasibility study with randomization to pilot test~     the ability of NICU-2-Home app to (a) improve parent's self-efficacy and confidence in caring~     for their VLBW infant, (b) decrease parental stress, and (c) enhance involvement with their~     VLBW infants compared to controls.~   "
120734|NCT01987167|"~     The goal of the study is to determine the earliest structural changes in the optic nerve~     during the acute event and during the twelve months of recovery following Acthar treatment.~   "
120735|NCT01987154|"~     To evaluate the use of a hypoallergenic infant formula containing an extensively hydrolyzed~     protein source for routine nutrition.~   "
120736|NCT01987141|"~     Less than one third of pregnant women actually achieve the Institute of Medicine's (IOM)~     recommended weight gain. To date, there are no randomized controlled trials studying the use~     of the electronic medical record to alert providers to initiate the counseling of patients on~     the IOM gestational weight gain recommendations.~      In the investigator's planned study intervention, using the EPIC EMR system, an electronic~     alert (Best Practice Advisory) will appear for providers at each prenatal care visit. This~     alert will remind providers to counsel patients on the recommendations for gestational weight~     gain. The control group will receive standard prenatal care, without electronic alerts~     generated regarding BMI and gestational weight gain.~      The investigators hypothesize that a higher percentage of patients who receive the~     intervention will meet the IOM guidelines for weight gain.~   "
120737|NCT01987128|"~     Aim of this study is to demonstrate the advantages of intraneural injection over extraneural~     injection in terms of onset and duration on peripheral block. In addition we will evaluate~     the frequency of possible adverse effects.~   "
120738|NCT01987115|"~     Trigger finger is a relatively common disorder affecting the hand. There is limited evidence~     on the efficiency of traditional physiotherapy in treating this condition. Fascial~     manipulation is a gaining momentum manual therapy method. To our knowledge the efficiency of~     fascial manipulation techniques in the treatment of trigger finger was not reported. The~     purpose of this study is to investigate the efficiency of the technique and to compare it~     with the traditional physiotherapy treatment.~   "
120739|NCT01987102|"~     An Open-Label, Multicenter, Phase I/II Clinical Trial to Identify the [6R]~     5,10-methylenetetrahydrofolate Dose with Most Favorable Safety Prospect and Confirmed Ability~     to Mitigate High-Dose Methotrexate Induced Toxicity during Treatment of Osteosarcoma Patients~   "
120740|NCT01987089|"~     Insomnia is a highly prevalent disorder in those recovering from alcoholism. It has been~     associated with anxiety and depressive symptoms, as well as an increased risk of relapse back~     to the drinking.~      Cognitive Behavioral Therapy for Insomnia (CBT-I), a non-pharmacologic approach is the~     recommended standard of care for insomnia. Some preliminary studies have shown that CBT-I may~     be efficacious for insomnia during recovery.~      The current study proposes to use a standard 8-week CBT-I to treat the insomnia with a~     post-treatment follow-up at 3- and 6-months (after treatment). Further, it will evaluate if~     an improvement in the insomnia is associated with an improvement in the underling alcoholism~     and the daytime functioning. On an exploratory basis, the association of a first-degree~     family history of alcoholism with the insomnia severity and treatment response will also be~     evaluated.~   "
120823|NCT01985997|"~     This is an observational post-marketing study conducted in children and adults immunized with~     Q/LAIV as part of routine clinical practice at Kaiser Permanente Northern California (NCKP)~     sites.~   "
120990|NCT01983813|"~     The trial will examine whether a centralized Prevention Health & Cardiovascular Risk Service~     (PHCVRS) run by clinical pharmacists at the University of Iowa can be implemented in primary~     care offices and whether it can improve the care delivered to patients at risk for developing~     cardiovascular disease. The study will be conducted in 12 medical practices in Iowa that are~     either a Federally Qualified Health Center or part of the IRENE practice-based research~     network.~   "
120741|NCT01987076|"~     Drug reaction with eosinophilia and systemic symptoms (DRESS) is a rare and severe multiorgan~     adverse drug reaction occurring within 2 to 6-8 weeks after a new drug intake. DRESS syndrome~     is defined by the combination of clinical manifestations, cutaneous, visceral and biological~     disturbances. Its prognosis is directly linked to severity of visceral involvement, with a~     mortality evaluated above 10%.~      Considering curative treatment, there is no consensus. Until now, no controlled trial has~     been performed. Systemic steroids are mainly used in first intention, in particular for~     management of visceral involvements, whatever their severity. From clinical practice, topical~     steroids are often used and could be helpful in the therapeutic management of DRESS.~      We propose to evaluate systemic steroids versus very potent topical steroids in a~     multicentric randomized controlled trial including defined moderate DRESS, ie the~     non-inferiority of very potent topical steroids in terms of remission of visceral involvement~     at Day30 and the superiority of very potent topical steroids in terms of delay to remission~     of skin involvement.~   "
120742|NCT01987063|"~     The purpose of this study is to determine the best obstetrical practices for twin delivery.~   "
120743|NCT01987037|"~     The aim of the study is to describe the feasibility of the passation of the assessment~     battery of psychomotor functions tests (NP-MOT) in children aged 4 to 11 years with a~     diagnosis of autism spectrum disorder: number and type of evaluable events, number and type~     of tests with a deficit compared to the standard results.~   "
120744|NCT01987024|"~     It consists of evaluating the advantage of routine detection of phIGFBP-1 to reduce the total~     duration of hospitalization for patients with a risk of preterm labor before 32 weeks of~     gestation without increasing the number of preterm labour.~      Methods Patient with a risk of preterm labor (ultrasound cervical length < 25 mm +/-~     described or recorded uterine contractions) before 32 weeks of gestation will be hospitalized~     to receive tocolytic drugs and antenatal corticosteroid therapy according to our gold~     standard protocol. After 48 hours, they will be assessed by examination, external~     tocodynamometry and the measure of cervical length by ultrasound. Stabilized patients will be~     included and randomized into 2 groups of 210 patients each. The first group A will benefit~     from the standard protocol (extended hospitalization of 2 or 4 days according to the clinical~     and ultrasound assessment); whereas the second group, B, will have the benefit of the~     detection of phIGFBP-1.If the result proves negative, patients could be discharged early at~     day 2. In the case of a positive result, patients will follow the standard procedure because~     of the low positive predictive value of the test. The main outcome is the total duration of~     hospitalization.~      Study duration The trial period will be 36 months.~      Expected results The use of detection of IGFBP-1 would enable us to select patients at risk~     and to decrease the duration of hospitalization in the case of a negative result.~      Perspectives The negative predictive value of phIGFBP-1 test could be useful to select~     patients with stabilized risk of preterm labor, who could be discharged early. Moreover it~     could be used, in the Perinat Sud network, to decide if patients with a risk of preterm labor~     would benefit from hospitalization in a level II or III maternity ward.~   "
120745|NCT01987011|"~     The purpose of this study is to evaluate the immunogenicity and safety of the investigational~     vaccine in the subjects during their participation in the study.~   "
120746|NCT01986998|"~     The investigators plan to carry out a multicenter randomized clinical trial and MRI study of~     high-dose oMP (1250mg/day for 3 days) versus lower-high dose oMP (625mg/day for 3 days) and~     demonstrated that lower-high dose of oMP is as effective as a higher-high dose of oMP in~     acute relapse of multiple sclerosis (MS). If it is shown, our purpose is to promote this~     therapeutic regimen because it is safer for the patient (less adverse effects) and less~     costly to the healthcare system.~   "
120747|NCT01986985|"~     The objective of this study is to gather image and associated data to of a pre-market PET/MRI~     scanner and to use the data for regulatory submission and future product development and~     marketing. Clinical data is required in order to test the MR attenuation correction of PET~     data. These aims can only be accomplished through a clinical study.~   "
120748|NCT01986972|"~     Purpose: The aim of this study was to compare the efficacy of dental biofilm removal by~     brushing with and without conventional toothpaste. Settings and Design: Twenty-four students~     aged 17 to 28 years old participated in this randomized clinical trial.~      Materials and Methods: Quadrants 1-3 or 2-4 were randomly allocated to the test group~     (brushing without dentifrice) or control group (brushing with dentifrice). After 72 hours of~     cessation of oral hygiene, Quigley & Hein (Turesky) plaque index was assessed before and~     after brushing by a calibrated and blind examiner. Overtime and intergroup comparisons were~     performed by paired sample t test.~   "
120749|NCT01986959|"~     Background: There is controversy regarding the postoperative effects of periodontal dressing~     on the periodontium, pain and discomfort. The aim of the present study was to compare~     postoperative pain following surgical crown lengthening with and without the use of~     periodontal dressing.~      Material and Methods: A blind, randomized, clinical trial was carried out with 36 patients.~     Following surgical crown lengthening, the individuals were randomly allocated to the~     periodontal dressing group (PDG) and control group (CG - non-placement of periodontal~     dressing). Pain and discomfort were analyzed using a visual analog scale (VAS), verbal scale~     (VS) and the number of analgesics consumed in seven days postoperatively. Postoperative~     infection, stability of the gingival margin and type of healing were also evaluated.~   "
120750|NCT01986946|"~     1. Protocol Title - A Comparison of Epidural Analgesia with Standard Care Following Lumbar~          Spinal Fusion: A Prospective Randomized Study~        2. Purpose of the Study - This prospective randomized study will enroll 200 patients~          undergoing elective Lumbar Spinal Fusion at Duke University Hospital. The primary~          objective is to determine the effect of epidural analgesia, as compared with standard~          care, on post-operative analgesia.~      Hypothesis:~      The investigators hypothesize that patients undergoing Lumbar Spinal Fusion surgery with~     epidural catheter placement will have superior post-operative analgesia compared to patients~     undergoing standard care.~   "
120751|NCT01986933|"~     To assess the safety, tolerability and efficacy of CIM331, compared to placebo, in atopic~     dermatitis patients who are inadequately controlled by or intolerant to topical therapy~   "
120752|NCT01986920|"~     Evaluate the safety, tolerability of A-101 when applied to seborrheic keratosis lesions on~     the back of subjects.~   "
124926|NCT01932268|"~     The purpose of this study is to examine the colchicine concentration before and after the~     administration of rifampicin.~   "
120757|NCT01986855|"~     This study will evaluate the efficacy and safety of ertugliflozin (MK-8835/PF-04971729) in~     participants with Type 2 diabetes mellitus with Stage 3 Chronic Kidney Disease (CKD) who have~     inadequate glycemic control on background antihyperglycemic therapy. The duration of this~     trial will be up to 67 weeks. This study will consist of a 1-week Screening Period, a 10-week~     wash-off period from metformin, if needed, and a 2-week placebo run-in period, a 52-week~     double-blind treatment period, and a 14-day post-treatment follow-up period. The primary~     objective of this trial is to assess the hemoglobin A1C (A1C)-lowering efficacy of the~     addition of ertugliflozin compared to the addition of placebo with an underlying hypothesis~     that addition of treatment with ertugliflozin provides greater reduction in A1C compared to~     the addition of placebo; the primary objective will be tested for both 5-mg and 15-mg doses~     of ertugliflozin.~   "
120758|NCT01986842|"~     Protein intake stimulates muscle protein synthesis. From the standpoint of maintaining~     skeletal muscle mass with aging, it is important to optimize the adaptive response to food~     intake. However, a paucity of information is available describing the effects of habitual~     dietary protein intake (i.e. either high or low amounts of dietary protein consumed on a~     regular basis), on the subsequent meal-induced stimulation of muscle protein synthesis. An~     adaptation to a diet of several days or weeks may involve splanchnic and/or skeletal muscle~     adaptations that may further enhance, or decrease, the amino acid sensitivity of muscle~     protein synthesis after protein ingestion.~      The aim of this study is to investigate the effect of a habitual (14 days) high protein diet~     when compared with low protein diet on digestion and absorption kinetics and the subsequent~     muscle protein synthetic response to dietary protein ingestion.~   "
120759|NCT01986829|"~     This phase II trial studies how well cryoablation, radiofrequency ablation, or microwave~     ablation works in treating patients with metastatic sarcoma stable on chemotherapy.~     Cryoablation kills tumor cells by freezing them. Radiofrequency ablation uses a~     high-frequency, electric current to kill tumor cells. Microwave ablation kills tumor cells by~     heating them to several degrees above body temperature.~   "
120760|NCT01986816|"~     The purpose of this study is to investigate the cost of treatment and adverse efffects therof~     corresponds to quality of life improvements and expected wheightloss.~   "
120761|NCT01986803|"~     This is a Prospective, randomized (1:1), active control, single-blind, non-inferiority,~     European multicenter clinical trial.~      The primary objective of this study is to assess the neointimal healing score (as evaluated~     by intra-coronary OFDI) in patients with ST-elevation Myocardial Infarction (STEMI) and~     treated with Abbott Vascular ABSORB everolimus eluting bioresorbable vascular scaffold (BVS)~     at 6 months follow-up by comparing with a metallic drug eluting stent (XIENCE). Furthermore,~     the safety and feasibility of implanting ABSORB BVS in patients with STEMI is assessed.~      It is hypothesized that acutely and at 6 months follow-up implantation of the ABSORB fully~     bioresorbable everolimus-eluting scaffold is at least as safe as implantation of metallic~     drug-eluting stent, and that at late follow-up the ABSORB scaffold could improve the arterial~     healing process and potentially reduce late stent thrombosis in patients presenting with~     STEMI.~      This is a preparatory trial in anticipation of a major outcome study.~   "
120762|NCT01986790|"~     The overall goal of the study is to better understand how communication strategies can help~     people make decisions about health insurance plans.~      This study aims to:~        -  (Aim 1) Examine currently uninsured individuals' understanding of terminology and~          details of health insurance plans;~        -  (Aim 2) Apply three recommended strategies for communicating information about health~          insurance plans;~        -  (Aim 3) Test the effects of these strategies in a randomized experiment.~   "
120763|NCT01986777|"~     This is a double-blind, placebo-controlled, study testing whether LDX improves cognitive~     function and EF in 20 postmenopausal women who report onset of cognitive difficulties after~     oophorectomy (with or without subsequent chemo/adjunctive therapy). Brain imaging is included~     at critical time points to obtain objective data regarding effects of LDX as well as~     potential predictors of resilience in the face of oophorectomy.~   "
120764|NCT01986764|"~     This project seeks to address cognitive disturbance, which is a frequent adverse sequelae of~     riskreducing bilateral salpingo-oophorectomy (RRSO) with or without post-procedure~     chemotherapy and adjunctive treatments. RRSO after completion of childbearing is recommended~     for prevention of ovarian and breast cancer in women with BRCA1/BRCA2 mutations and standard~     of care for women with some forms of hormone-responsive cancer. Knowledge regarding the~     impact of this procedure, with or without chemotherapy, and subsequent hypogonadism on brain~     health is less than adequate. Premenopausal women who undergo an acute surgical menopause are~     at greater risk for verbal memory decline and executive function (EF) complaints, but as of~     yet, we cannot predict who is going to experience these adverse sequelae, nor do we have~     targeted prevention or treatment strategies other than hormone therapy, which is not an~     option in many cases and not always effective. An idealized sample as women who are planning~     for a RRSO will undergo brain imaging and behavioral assessments pre- and post-surgery as~     well as pre-/post-treatment with E2 or the psychostimulant, lisdexamphetamine (LDX;~     Vyvanse®).~   "
120765|NCT01986751|"~     Nerve blocks are used to decrease the amount of pain you have after surgery. We are asking~     you to take part in a research study. This research study will test whether adding a medicine~     called clonidine to nerve blocks helps to improve them. Nerve blocks typically last less than~     a day after surgery. We are looking for ways to make them work better and last longer.~     Clonidine is approved for use as a blood pressure medicine. Its use in nerve blocks is~     investigational, but it may help nerve blocks to last longer. Adding clonidine to nerve~     blocks may also decrease the amount of pain medicine a person has after surgery. All people~     who enter this study will receive a nerve block with the normal medicine, but half of people~     will also have clonidine added to their nerve block. This study will enroll 60 participants~     from UAB hospitals.~   "
120766|NCT01986738|"~     This is a study to assess the motion of pancreatic tumors during radiation therapy using~     Computed Tomography (CT) Scans and an Active Breathing Control (ABC) Device.~   "
121003|NCT01983644|"~     Endovascular therapy is increasingly used for patients with moderate-to-severe acute ischemic~     stroke.This study will compare the efficacy and safety of RECO(a novel, self-expanding stent~     retriever) with Solitaire FR within 8 hours of stroke onset caused by the large vessel~     occlusion.~   "
120767|NCT01986725|"~     In vulvar neoplasia, even minor surgical interventions cause multiple symptoms, symptom~     distress and complications, which have an impact on a woman's quality of life and contribute~     to high health care costs. For the majority of the patients, symptom and distress can be~     reduced if adequate treatment is provided. This study aims to test possible differences~     between the impact of standardized care and the WOMAN-PRO II program on symptom prevalence in~     women with vulvar neoplasia after surgical treatment.~      In a sequential explanatory mixed-methods project, a randomized phase II study will be~     followed by a qualitative sub-study. Ninety patients with vulvar neoplasia treated surgically~     will participate in the randomized trial in four Swiss hospitals and one Austrian hospital.~     After stratification by precancer/cancer, women will be randomly assigned (1:2 ratio) to~     standardized care and the WOMAN-PRO II program. The standardized care group will receive a~     set of information leaflets about supportive care options in the clinic. The WOMAN-PRO II~     program group will obtain counseling sessions by specially trained gynecology-oncology nurse~     specialists at the moment of diagnosis, 7 days post-surgery, in week two after discharge,~     week twelve and week 24 after surgery. The primary outcome of this study is symptom~     prevalence. Secondary outcomes will be collected for explorative reasons and include symptom~     distress, uncertainty, quality of life, social support, resilience, quality of care,~     sociodemographic and medical characteristics, post-surgical complications, functional status,~     cost evaluation and process outcomes. Quantitative data will be collected at the counseling~     points of time and analyzed by using mixed linear regression analysis. Twenty interviews will~     be conducted with women of the WOMAN-PRO II program group. A focus-group interview will be~     conducted with twelve gynecology-oncology nurse specialists in order to better understand to~     which degree the interventions meet individual needs as well as to identify remaining~     barriers and enablers for the implementation of symptom self-management. Qualitative data~     will be analyzed by using thematic analysis and a critical hermeneutic reflection.~      This study will evaluate the impact of the WOMAN-PRO II program on symptom prevalence,~     patient-reported outcomes and clinical parameters, and inform the design of a possible phase~     III study on the clinical efficacy of the program.~   "
120768|NCT01986712|"~     To evaluate the compliance with and perceptions of treatment, as well as health-related~     quality of life (HRQOL) in surgically resected melanoma patients undergoing HDI or PEG IFN~     therapy.~   "
120769|NCT01986699|"~     Study Objective: To compare the hospital costs between the standard surgical procedure and~     the Laparascopic Assisted Colonoscopic Polypectomy (LACP) technique for patients with~     advanced polyps in the colon.~   "
120770|NCT01986686|"~     Patients will agree to be randomized to either surgery or observation following nonoperative~     management of a first episode of Hinchey II diverticulitis. Information will be collected on~     recurrence rates and major complications in both groups.~   "
120771|NCT01986673|"~     The purpose of this study is to evaluate how a single dose of sildenafil cream (SST-6006) is~     absorbed and eliminated by the body, with and without the use of a condom, compared to a~     single oral sildenafil dose and to evaluate the safety of sildenafil cream.~   "
120772|NCT01986660|"~     The purpose of this study is to evaluate how Ibuprofen Cream (SST-0225) is absorbed and~     eliminated by the body under defined maximum dosing conditions and to evaluate the safety~     under these conditions.~   "
120773|NCT01986647|"~     Community-dwelling older adults fear loss of independence and nursing home placement more~     than death. Walking difficulty often leads to loss of independence. Exercise is beneficial to~     physical and mental health and may prevent walking difficulty and promote independence.~     Recognizing the importance of exercise, senior housing facilities offer exercise programs to~     their residents. The exercise programs are often group-based, seated range of motion~     exercises that do not challenge the older adult; consequently participation rates and~     resident satisfaction are low.~      If the goal is to improve walking to promote independence than the exercise program should~     specifically target walking. Therefore, we developed a challenging, group exercise program~     entitled On the Move which focuses on the fundamentals of walking. In this research study~     we will determine if the On the Move program is better than a standard program at improving~     walking and promoting independence and if the same benefits can be obtained if the On the~     Move program is delivered by staff of the senior living facilities instead of an exercise~     leader. To answer these questions, 400 community-dwelling older adults living in 32 different~     Independent Living Facilities and Senior High Rises or living in the community and attending~     senior community centers will be randomly assigned to either the 12 week On the Move group~     exercise program or the standard group exercise program delivered by either an exercise~     leader or staff activity personnel. Participants' walking and reported ability to carry out~     everyday activities (functional ability) will be assessed before and after the 12 week~     program. We will also assess participant safety and satisfaction with the exercise program~     and instructor.~      The findings from this research study will provide evidence for the value of the On the Move~     group exercise program and will better inform patient choices regarding participation in~     exercise programs. If successful in improving walking and promoting independence and~     acceptable to the older adult, the On the Move program could be incorporated into exercise~     programming for older adults in community centers, health clubs, and senior residences across~     the country.~   "
120774|NCT01986634|"~     Perioral rhytides present a difficult problem in facial rejuvenation. They cannot be~     addressed with rhytidectomy (face lift) and direct excision can leave visible unfavorable~     scars. Currently, fine static wrinkles are most effectively treated with facial resurfacing,~     usually with laser treatment. Often the peri-oral area is treated with additional spot~     treatments with an ablative laser to cause a more robust healing response and better aesthtic~     result. To date, no studies have specifically shown efficacy of additional spot treatment~     over full facial laser alone.~      This study is designed as a split-face study, to compare the aesthetic results of full field~     laser resurfacing on one half of the face with that of spot treatment of perioral rhytides on~     the other half.~      To clarify further to the IRB board, this is not an experimental treatment. Spot treatment is~     used by many surgeons/laser proceduralists for addressing specific areas of the face. This is~     an FDA indicated use of the laser for facial resurfacing. Due to the many genetic and~     enviromental factors that can effect the results the best design for the study to is have~     each patient serve as their own control with a split-face study.~   "
120775|NCT01986621|"~     This pilot study aims to identify patients at moderate to high risk for peri-procedural (type~     4) myocardial infarction or injury after after undergoing an elective coronary intervention~     (PCI) as measured by high sensitivity troponin T, who might benefit from more potent~     antiplatelet therapy.~   "
120776|NCT01986608|"~     This study will be conducted to compare the pharmacokinetics of Lacosamide (LCM) following a~     single 30-minute or 60-minute iv infusion of LCM 200 mg with those following a single oral~     dose of LCM 200 mg in healthy Japanese subjects.~   "
120777|NCT01986595|"~     Neuroblastoma (NB) originates from the sympathetic nervous system and is one of the most~     common cancers in infants and children. In our hospital, nearly 70% of patients are diagnosed~     with stage 4, metastatic disease with a poor prognosis, despite the use of multimodal therapy~     including chemotherapy, surgery, autologous stem cell transplantation, radiation therapy, and~     differentiation therapy. To improve the survival rate and patient care, our NB Study Group~     has devoted to the research on NB-specific molecular imaging, biomarkers, and target therapy.~     We have confirmed studies in cancer genetics by showing that N-myc gene (MYCN) amplification~     and segmental abnormalities on overall genomic profiling both have an adverse effect on~     treatment outcome. Therefore, there is an unmet need for the development of novel molecular~     target therapy in NB. Recently, the anaplastic lymphoma kinase (ALK) oncogene has been found~     to play an important role in the pathogenesis of NB, as well as serving as the driver~     mutations in approximately 10% of high-risk NB. The availability of ALK inhibitors also~     enables ALK as a treatment target in NB. In this proposal, we plan to utilize gene~     sequencing, array-comparative hybridization, and multiplex ligation-dependent probe~     amplification methods to evaluate the frequencies and characteristics of ALK mutations and~     amplifications in patients with NB. The gene and protein expression of ALK will also be~     evaluated by quantitative polymerase chain reaction(PCR) and immunohistochemistry,~     respectively, and compared with ALK genotype. The overall genomic pattern, clinical~     characteristics, histopathology, and treatment outcome of ALK-mutated NB patients will be~     analyzed. The results from this study may serve as the first report on ALK mutations of NB in~     Taiwan and will be used for the development of standardized genetic diagnosis protocols, as~     well as the design of future clinical trials targeting ALK.~   "
120778|NCT01986582|"~     Allergic rhinitis is treated with a variety of systemic and locally applied drugs. The~     effectiveness of the intranasally applied formulations is diminished by the cleaning~     mechanisms of the nose, rhinorrhea in particular. Slowing down of the clearance of the nasal~     mucosa and prolonging the contact time of locally applied drugs with the nasal mucosa would~     improve their efficacy. One method is creating dosage forms containing mucoadhesive polymers.~     We have demonstrated that a mucoadhesive solution containing HPMC enhances the clinical~     efficacy of oxymetazoline. However, the industrial development of fixed combinations of~     pharmaceutical compound and mucoadhesive carrier requires substantial investments, escalating~     manifold if different pharmaceutical compounds have to be rendered mucoadhesive.~      NoAl is a cellulose derivative powder, which forms a gel layer on contact with the mucosal~     surface of the nose blocking the contact of the pollen grains with the nasal mucosa in~     seasonal allergic rhinitis. However, there is another potential benefit of applying NoAl~     (HPMC) along with other commercially available drugs for local treatment of rhinitis, as the~     formation of a gel layer can substantially delay their clearance from the nose and thus~     increase their effectiveness. This hypothesis needs to be substantiated clinically.~   "
120779|NCT01986569|"~     The standard diagnostic workup for recurrent or metastatic breast cancer includes biopsy and~     determination of tumor estrogen status according to National Comprehensive Cancer Network and~     European Society for Medical Oncology. Immunohistochemistry (IHC) is currently the most~     commonly used method for determining ER status. A investigational imaging tracer named~     16-alpha-[18F]-fluoro-17-beta-estradiol, or [18F]fluoroestradiol ([18F]FES) acts similarly in~     vivo to estradiol and binds to estrogen receptors (ERs). Previous studies in human have shown~     the efficacy of [18F]FES PET in detecting ER positive breast cancer without any observed~     toxicity. The investigators hypothesized that [18F]FES PET imaging can noninvasively assess~     ER status in recurrent or metastatic breast cancer lesion . In this study, a positive and~     negative percent agreement between IHC and [18F]FES will be determined.~   "
120780|NCT01986556|"~     This study will assess the relative bioavailability of lesinurad tablets, manufactured at two~     different sites.~   "
120781|NCT01986543|"~     We propose a first interaction study between efavirenz (EFV) and R20mg/Kg taking into~     consideration the absence of data about R induction at this dose. Due to an important~     inter-patient variability of the CYP2B6 polymorphism, the EFV pharmacokinetic (Pk) will be~     compared in same patients with and without TB treatment.~      The main objective is to compare the Pk parameters of EFV in HIV-TB co-infected patients,~     with and without TB treatment, using R at 10 and 20mg/Kg/day and EFV at 600 and 800mg/day.~   "
120782|NCT01986530|"~     Irisin, a newly discovered myokine induced in exercise, has potential effects in stimulating~     adipose tissue browning, fighting obesity and diabetes. No prior study has reported on the~     role of circulating irisin in healthy individuals in correlation with lean and fat body mass.~     Furthermore, the circadian and seasonal variation of irisin is largely unknown.~   "
120783|NCT01986517|"~     The purpose of the current study is to examine the influence of feedback on psychotherapeutic~     competency. The present randomized controlled study compares a feedback condition with a~     non-feedback condition. Therapists in the feedback condition receive feedback after every~     fourth session. The feedback is given by two trained and independent raters. The raters are~     licenced and experienced psychotherapists. Therapists in the non-feedback condition receive~     no feedback during the psychotherapy.~   "
120784|NCT01986504|"~     The Transplant Infectious Diseases Prospective Cohort Study facilitates the prospective~     identification and collection of data of infectious disease complications in order to~     determine the epidemiology, risk factors, and outcomes of patients who receive solid organ or~     stem cell or plastic surgery transplants at Johns Hopkins and other transplant centers. It is~     essential for the care and treatment of this population to employ a mechanism for~     investigators to centralize these datasets, using standardized definitions of infectious~     complications. This protocol outlines the procedures to be utilized in order to prospectively~     follow the diagnosis and treatment of infectious complications in transplant patients.~   "
120785|NCT01986491|"~     The purpose of the study is to compare the pharmacokinetics (what a medication does to the~     body), dose-proportionality, safety and tolerability of JNJ 39393406 following single dose~     oral administration of two solid oral formulations in Part 1; based on the profile in Part 1,~     one of the formulations assessed will be selected to investigate the pharmacokinetics in~     fasting condition in Part 2 and after repeated dosing in Part 3.~   "
120786|NCT01986478|"~     To collect data for a reference database.~   "
120787|NCT01986465|"~     The aim of this study is to evaluate the effectiveness of steroid injection and~     immobilization versus no immobilization in treating patients with lateral epicondylitis.~   "
120788|NCT01986452|"~     Apoplexy patients with OSA are often not receiving a CPAP therapy due to generally poor~     acceptance and adherence. There is a great potential to significantly improve the treatment~     and care of these patients in a time economic way by telemonitoring the therapy in home~     environment.~      This study is planned to prove that telephone consultancy and motivation in times of recorded~     decreasing CPAP therapy usage can improve adherence, neurological function and quality of~     life.~   "
120789|NCT01986439|"~     The purpose of this project is to remove barriers to obtaining contraceptive methods,~     including the most effective and expensive methods. The study seeks to remove the financial~     and knowledge barriers and promote the most effective contraceptive methods to reduce~     unintended pregnancy rates at the population level.~   "
120790|NCT01986426|"~     The study will assess the safety, tolerability, PK and efficacy of different intra-tumoral~     dosing regimens of LTX-315; a lytic-peptide that induces long-term anti-cancer immune~     responses, as monotherapy or in combination with ipilimumab or pembrolizumab.~   "
120853|NCT01985607|"~     Cow Milk Allergy (CMA) occurs in 2 to 5 % of all infants. Reflux, regurgitation and vomiting~     are well recognised symptoms of CMA. The recommended treatment of CMA is an extensive~     hydrolysate. The North American Society of Pediatric Gastroenterology Hepatology and~     Nutrition (NASPGHAN) & the European Society of Pediatric Gastroenterology Hepatology and~     Nutrition (ESPGHAN) reflux guidelines have no strict recommendations for the treatment of~     distressed infants with reflux, suspected of CMA. One of the preferred proposed options is to~     thicken an extensive hydrolysate .~      This study aims at evaluating the additional value of a thickened extensive hydrolysate in~     children suspected of CMA and presenting with frequent regurgitation.~   "
120791|NCT01986413|"~     Aim of this prospective randomized trial is to compare non invasive ventilation (NIV) with~     pressure control (BiPAP-ST) to volume assured pressure support (iVAPS) with regards to sleep~     quality and alveolar ventilation in patients with routine NIV initiation after COPD~     exacerbation.~      20 patients with COPD and chronic hypercapnic respiratory failure will spent two nights on~     NIV, one with spontaneous timed pressure controlled bilevel ventilation (BiPAP-ST) and one~     with the advanced mode of intelligent volume assured pressure support (iVAPS). Patients will~     spend the treatment nights in randomized order under polysomnographic surveillance, including~     transcutaneous PCO2 measurement. Besides the number of arousals and PCO2 values over night~     the sleep quality will be judged with regards to especially adjusted respiratory event~     criteria like unintentional leaks, patient ventilator asynchrony, and decrease of ventilatory~     drive.~   "
120792|NCT01986400|"~     Study Hypothesis: A virtual peer-to-peer support intervention will improve health outcomes~     and quality of life in adolescents with Juvenile Idiopathic Arthritis~   "
120793|NCT01986387|"~     Study Hypothesis: A virtual peer-to-peer support intervention will improve health outcomes~     and quality of life in adolescents with chronic pain.~   "
120794|NCT01986374|"~     The endometrium is deprived of signals form the embryo in IVF conditions. Studies suggest~     that placing HCG into the uterus prior to embryo transfer can enhance implantation.~   "
120795|NCT01986361|"~     The study's purpose is to demonstrate the onset of action, i.e., time to meaningful pain~     relief in patients with pharyngitis, of flurbiprofen 8.75 mg lozenge using the~     Double-Stopwatch Method (DSW).~   "
120796|NCT01986348|"~     This is an open-label, multicenter, Phase 2 study to evaluate the efficacy and safety of oral~     Selinexor in patients with recurrent gliomas. Patients have been enrolled in Arms A, B and C,~     but Arm D is the only arm currently open to recruiting patients.~   "
120797|NCT01986335|"~     The objectives of this study were to analyze the immunogenicity and reactogenicity of~     DTP/HB/Hib (Bio Farma) combination vaccine.~   "
120798|NCT01986322|"~     The main objective of this study was to evaluate the protectivity and safety of DTP/HB/Hib~     (Bio Farma) vaccine compared to DTP/HB and Hib vaccine given simultaneously.~   "
120799|NCT01986309|"~     There some evidence regarding the effect of lidocaine for the prevention of nausea and~     vomiting in adults.~   "
120800|NCT01986296|"~     The goal of this prospective, non-randomized, single-arm, single site, feasibility study is~     to develop and collect data to evaluate the safety and initial effectiveness of this~     treatment using this ExAblate transcranial System in the treatment of Medication-Refractory~     OCD.~   "
120801|NCT01986283|"~     This study will determine the relative abuse potential of intact and chewed PF-00345439~     (Oxycodone Extended-Release Capsules) compared to crushed oxycodone HCL immediate release~     (IR) tablets and placebo administered orally to non-dependent, recreational opioid users.~   "
120802|NCT01986270|"~     The objective of this study was to compare the efficacy, toleration and safety of eletriptan~     40mg and 80mg, with sumatriptan 25mg and 50mg, and placebo when given orally to subjects with~     an acute migraine.~   "
120803|NCT01986257|"~     The primary aim is to investigate the effectiveness of Emotion Regulation Group Therapy~     (ERGT) for women who self-harm in ordinary psychiatric outpatient health care.~   "
120804|NCT01986244|"~     The purpose of this study is to prospectively evaluate the functional outcome and patient~     satisfaction of total ankle replacement for tibio-talar osteoarthritis.~   "
120805|NCT01986231|"~     The purpose of this study is to learn if giving multiple doses of a hormone called glucagon~     can cause a major decrease in liver glycogen (animal starch). Glucagon is currently approved~     by the Food and Drug Administration to be given as a large dose to treat severe low blood~     sugar. Our group is studying whether glucagon can be given in repeated small doses to prevent~     hypoglycemia.~   "
120806|NCT01986218|"~     The primary purpose of this study is to evaluate the safety and effectiveness of daily doses~     of BMS-986115 in subjects with advanced solid tumors~   "
120807|NCT01986205|"~     The purpose of this study is to examine whether 40 hyperbaric oxygen sessions has effect on~     long-term symptoms after concussion. This study will enroll 90 individuals with persistent~     problems 1-5 years after a mild traumatic brain injury. These individuals will be randomized~     to receive either oxygen or air in a pressurized hyperbaric chamber. Participants will~     receive 40 daily hyperbaric chamber sessions.~      Participants will have a series of tests and questionnaires before they begin their chamber~     sessions, after they complete 40 sessions, and 6 months after they joined the study. These~     tests include computer-based and pencil-and-paper questionnaires and thinking tests, brain~     imaging, a neurological examination, and an eye exam. Participants will also be asked to~     provide blood for future research.~   "
120808|NCT01986192|"~     The EINSTEIN program showed that oral rivaroxaban is effective and safe treatment for~     prevention of recurrent venous thrombosis and pulmonary embolism in deep vein thrombosis~     patients and FDA approved the rivaroxaban for prevention and treatment of deep vein~     thrombosis (Nov 2 2012).~      Recently, catheter-directed thrombolysis can significantly reduce post-thrombotic syndrome,~     and more and more centers introduce catheter-directed thrombolysis to treat proximal (i.e,~     iliofemoral) DVT. However, the EINSTEIN program excluded patients with deep vein thrombosis~     if they had been treated with a vena cava filter or a fibrinolytic agent for the current~     episode of thrombosis.~      Although catheter-directed thrombolysis (CDT) or pharmacomechanical thrombolysis has now been~     accepted as a treatment of choice in iliofemoral DVT, thrombolysis has an inherent risk of~     bleeding. Therefore, patients who have completed CDT and have been stabilized at least 24~     hours after thrombolysis will be included in this study.~      Also, the investigators want to explore the efficacy and safety of rivaroxaban in patients~     with iliofemoral DVT after catheter-directed thrombolysis and/or a vena cava filter insertion~     and/or venous stent insertion and compare these outcomes with warfarin treatment alone.~      This study will be a pilot study to establish the safety and efficacy parameters for further~     studies.~   "
120854|NCT01985594|"~     RESEARCH HYPOTHESIS~      -Incidence of preterm delivery is lower in women treated with oral micronized progesterone~     (Utrogestan) as acute tocolysis agent compare to Nifedipine group with fewer maternal side~     effect~   "
124951|NCT01931943|"~     Brief Description:~      This study is designed to evaluate the safety and tolerability of oral Selatinib Ditosilate~     Tablets, and explore the maximum tolerated dose (MTD) and dose-limiting toxicity in patients~     with advanced breast cancer.~   "
120809|NCT01986179|"~     Professional interpretation improves quality of care for patients with limited English~     proficiency (LEP). However, many health care settings lack access to professional~     interpreters, and even in locations with good access, logistical factors and perceived~     barriers have limited their widespread use. Remote methods of professional interpretation,~     including telephone and video, hold great promise for expanding access, but only limited data~     exist on the relative impacts of these modalities on patient care and provider uptake.~     Comparing how these modalities impact multiple aspects of health care quality, including~     family comprehension, provider communication, and consistency of provider interpreter use~     will inform dissemination of strategies for delivery of safe, efficient, and equitable care~     to LEP families.~      Aim 1: To determine whether randomly assigned remote interpreter modality (telephone versus~     video) impacts parent-reported quality of communication and interpretation, diagnosis~     comprehension, and length of stay (LOS) among LEP Spanish-speaking families seen in a~     pediatric Emergency Department (ED).~      Hypothesis 1: Parent-reported quality of communication and interpretation and parent~     diagnosis comprehension will be higher among families assigned to video interpretation~     compared to telephone interpretation.~      Hypothesis 2: LOS will not differ between families assigned to video and telephone~     interpretation.~      Aim 2: To determine whether assigned interpreter modality is associated with provider~     decision to communicate without professional interpretation.~      Hypothesis 3: Parent-reported provider communication without professional interpretation~     (e.g. using the patient or a family member to interpret for some part of the visit) will be~     lower for families assigned to video interpretation compared to telephone interpretation.~   "
120810|NCT01986166|"~     This open-label, multicenter, global Phase Ib study will evaluate the safety, tolerability~     and pharmacokinetics of intravenous (IV) dosing of MEHD7945A in combination with oral dosing~     of cobimetinib in patients with locally advanced or metastatic solid tumors that carry a~     Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) mutation and for which standard therapies~     do not exist, have proven ineffective or intolerable or are considered inappropriate. The~     study comprises a dose-escalation (Stage 1) and an indication-specific cohort expansion stage~     (Stage 2).~   "
120811|NCT01986153|"~     The purpose of this study is to determine if patients on long-term olive oil-based parenteral~     nutrition have an adequate essential fatty acid status and immune status, compared to age-~     and sex-matched healthy controls.~   "
120812|NCT01986140|"~     Determine that the Orbis Paxman Hair Loss Prevention System is safe and effective in reducing~     chemotherapy-induced alopecia in woman with breast cancer undergoing neoadjuvant or adjuvant~     chemotherapy.~   "
120813|NCT01986127|"~     We study if the administration of intralesional Adalimumab (directly injected in the~     stricture) associated to endoscopic dilatation has a higher success rate at week 8 compared~     with placebo in patients with Crohn's disease who had confirmed intestinal stenosis (3~     stenosis as maximum)~   "
120814|NCT01986114|"~     The study evaluates the long-term efficacy and safety of SM-13496 in patients with bipolar I~     disorder.~   "
120815|NCT01986101|"~     The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients~     with Bipolar I Depression.~   "
120816|NCT01986088|"~     A previously published, placebo-controlled, head-to-head comparator study found eletriptan to~     have superior efficacy to oral sumatriptan 100 mg in treating a single acute migraine attack.~     The goal of the current study was to extend the findings of that study by examining the~     efficacy of eletriptan compared with both 50- and 100-mg doses of sumatriptan; and to~     evaluate the comparative efficacy of eletriptan and sumatriptan across additional important~     clinical outcomes. In particular, early response (at 1 hour), sustained response (without~     need for additional treatment) at 24 hours, and consistency of response across multiple~     attacks were examined.~   "
120817|NCT01986075|"~     This study will investigate a treatment strategy in which a computer-assisted behavioral~     intervention will be used to help individuals stop their use of cocaine. A medication will be~     combined with the behavioral treatment among those individuals who do not respond to the~     behavioral intervention alone. The primary hypothesis of the study is that among cocaine~     dependent individuals who fail to respond to an initial trial of behavioral therapy, a~     greater proportion of individuals will benefit from the combined treatment (behavior therapy~     plus medication) compared to individuals in the comparison group.~   "
120818|NCT01986062|"~     This is a dose-optimized, randomized, double-blind, placebo-controlled crossover study in~     approximately 100 pediatric patients (aged 6 to 12 years) with ADHD. Eligible patients will~     enroll in the study to take open-label AR11 twice daily and undergo dose optimization~     activities for 8 weeks. Patients who achieve a stable dose during the dose optimization~     period will continue participation and will be randomized to take double-blind medication~     (AR11 or placebo) orally twice daily for 1 week. At the end of the first double-blind~     treatment period, patients will be evaluated for ADHD symptoms in a laboratory classroom~     setting utilizing SKAMP and PERMP assessments. At the end of the second double blind~     treatment period, patients will be evaluated for ADHD symptoms in a second laboratory~     classroom setting utilizing SKAMP and PERMP assessments.~   "
120819|NCT01986049|"~     Adding TAP block with Bupivacaine may decrease the use of PCA bolus use after caesarean~     section for pain relief.~   "
120820|NCT01986036|"~     High-protein meals have previously been shown to acutely reduce appetite and energy intake.~     More recently, meals higher in calcium have also been shown to increase feelings of fullness,~     circulating insulin and intestinal peptide concentrations and reduce appetite sensations.~      This study aims to assess whether calcium and protein act synergistically to acutely~     influence appetite and energy intake.~   "
120821|NCT01986023|"~     The impact of medications used for secondary stroke prevention relies heavily upon patient~     adherence. Adherence is defined as the extent to which a person's behavior - taking~     medication, following a diet, and/or executing lifestyle changes, corresponds with agreed~     recommendations from a health care provider. It is said that optimal adherence to~     medications may reduce the risk of a poor outcome by 26%.~      The purpose of this study which is a non-pharmacologic behavioral study is to encourage~     adherence to medications in stroke survivors by tailored and specific SMS reminders. (Short~     Text Messages). These SMS reminders will support and assist stroke patients to take~     medications as prescribed and on time. We hypothesise that SMS will improve the adherence of~     patients to stroke medications by 2 points on the Morisky Medication Adherence Scale.~   "
120822|NCT01986010|"~     This study will evaluate the safety, tolerability, and immunogenicity of various doses,~     formulations, and routes of administration of Human Cytomegalovirus (HCMV) vaccine V160~     administered in a 3-dose regimen in healthy adults. Each treatment arm of 10 participants~     will be accompanied by a placebo arm of 4 participants. The initial treatment arm of HCMV~     seropositive participants will receive V160 Low Dose without adjuvant by intramuscular~     injection. Escalation of the V160 dose, inclusion of adjuvant, administration by intradermal~     injection, and vaccination of HCMV seronegative participants will be performed only after~     review of safety data of previous treatment arms. The purpose of the study is to identify~     vaccine formulations associated with optimal safety profile and HCMV-specific immune response~     for evaluation in subsequent clinical studies of V160.~   "
120824|NCT01985984|"~     The primary and general objective of the clinical introduction of the Standard Follow-up~     Program (SFP) as the current standard of care is to improve the quality of radiotherapy for~     head and neck cancer patients by reducing radiation-induced side effects without hampering~     treatment efficacy in terms of locoregional tumour control and overall survival and to~     systematically evaluate the beneficial effect of newly introduced radiation technology for~     this particular group of patients. The clinical introduction of the SFP will allow for a~     systematic and broad scale quality improvement cycle for head and neck cancer patients~     treated with radiotherapy. In fact, this methodology can be considered a kind of quality~     circle for the clinical introduction of new radiation techniques, aiming at continuous~     efforts for further improvement.~   "
120825|NCT01985971|"~     To estimate the presence of hypoxia in individual lesions after radiotherapy in patients with~     brain metastases from breast cancer as identified by F18 EF5 PET/CT imaging.~   "
120826|NCT01985958|"~     Primary Objective: To estimate the rate at which radiotherapy to the primary or a metastatic~     lesion produces an immune response in patients with metastatic carcinoma of the pancreas.~      Secondary Objectives: To characterize the kinetics of an immune response induced by~     radiotherapy. To characterize the dependency of the immune response on prior exposure to~     chemotherapy.~   "
120827|NCT01985945|"~     The purpose of this study is to examine the use of Eischens yoga for 8 weeks in one cohort of~     20 women with stage I and II breast cancer receiving radiation therapy treatment, while a~     second cohort of the same type of and number of patients who, instead of yoga will receive~     standard supportive therapy, Questionnaire measuring cancer-related quality of life (FACT-G~     instrument) and fatigue (Brief Fatique Inventory) will be given to patients at several~     points.~   "
120828|NCT01985932|"~     This study is being done to evaluate the use of MRI during radiation treatment planning to~     identify areas of tumor within the prostate to aid in future treatment planning and targeting~     of prostate cancer. This study will be conducted at the University of Pennsylvania Health~     System. The study is projected to run for 18 months. Subjects will be male 18 or older with a~     prostate cancer diagnosis and treatment plansat the Department of Radiation Oncology.~   "
120829|NCT01985919|"~     This clinical research protocol is intended to allow for bone marrow aspirate/biopsy and~     blood specimens to be collected for research purposes, specifically allowing subjects the~     option of sedation during the bone marrow procedure. Samples will be banked for future~     research related to cancer and other diseases. Researchers hope this protocol will improve~     the collection of research correlative and translational biopsy specimens for clinical~     research.~   "
120830|NCT01985906|"~     Complex aortic aneurysms involving major branches have been difficult endovascularly. The~     primary purposes of this study is to evaluate the safety, feasibility, and efficacy of~     multiple overlapping uncovered stents in treating aortic aneurysm while preserving major~     visceral branches, including the celiac artery (CA), superior mesenteric artery (SMA) and~     renal artery (RA).~   "
120831|NCT01985893|"~     The purpose of this study is to estimate the clinical benefit of lapatinib plus trastuzumab~     compared to lapatinib plus capecitabine as measured by investigator-assessed progression-free~     survival, tumour response and overall survival.~   "
120832|NCT01985880|"~     The purpose of this study is to evaluate efficacy of biomarker in patient with interstitial~     cystitis/painful bladder syndrome~   "
120833|NCT01985867|"~     The aim of this study is to assess the effectiveness of Lactobacillus casei rhamnosus Lcr35~     administration for the treatment of functional constipation in children.~   "
120834|NCT01985854|"~     Since neurological testing during neurosurgery, such as somato-sensory evoked potentials,~     motor-evoked potentials, auditory evoked potentials and visual evoked potentials are well~     maintained their wave-form reactivity with total intravenous anaesthesia technique better~     than inhalational anesthetic techniques, the standard anesthesia method for neurosurgery is~     usually total intravenous anaesthesia technique. Nonetheless, after finishing recording the~     evoked potential responses during surgery, facilitation of recovery from general anesthesia~     is getting important, because the real neurological physical examination is much more~     sensitive than above electrical evoked potentials to evaluate the results of surgical~     operation.~      We propose to evaluate the recovery parameters after conversion from total intravenous~     anaesthesia technique to Desflurane anesthesia during long term neurosurgery procedures. The~     conversion will be initiated upon completion of the neurophysiological electric evoked~     potentials assessment. Based on the pharmacological properties of desflurane, we hypothesize~     that recovery after conversion to Desflurane will be faster compared to recovery after total~     intravenous anaesthesia alone.~   "
120835|NCT01985841|"~     Investigators propose to study the efficacy of Bevacizumab plus systemic chemotherapy prior~     to surgery in order to make a locally advanced tumor operable. Treatment is thus expected to~     induce a maximum tumor shrinkage within a short period (usually 3-6 months). In addition~     Bevacizumab (Avastin) is to be administered as early as possible during the disease stages.~     The primary aim of this study is to evaluate the preliminary antitumor activity in terms of~     pathological complete responses (pCR) of bevacizumab in combination with chemotherapy.~   "
120855|NCT01985581|"~     This study looks to examine whether or not INTUNIV extended release can help children aged~     6-12 years diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) in improving~     Executive Function when added to their usual care stimulant therapy. Executive functions are~     a set of mental processes that include emotional control, planning, organization, working~     memory, inhibition of behaviors, and managing time and space. As children with ADHD usually~     have difficulties with Executive Function, and Executive function difficulties lead to more~     difficulties in school and behaviour, it is anticipated that adding INTUNIV extended release~     to usual stimulant therapy will improve Executive Function scores as rated by parents and~     teachers. Improvements in quality of life will also be measured.~   "
120891|NCT01985113|"~     In pre-clinical study the investigators found that the thioredoxin reductase activity of~     serum harbours huge difference between cancer patients and non-cancer patients, the enzyme~     activity elevated remarkably among cancer patients, so the investigators hypothesis that this~     is due to tumor cells loading of the patients, the enzyme activity may harbours huge~     difference between carcinoma tissues and para-carcinoma tissues in early staged non-small~     cell lung cancers, and after surgery, the enzyme activity may fall down to a normal level~     because of removing of tumor.~   "
120836|NCT01985828|"~     The primary objective of this study is to document the effectiveness of Cyberknife~     stereotactic body radiotherapy (SBRT) in the treatment of intermediate and high-risk~     localized prostate cancer defined by biochemical Disease-Free Survival (bDFS), using Phoenix~     and American Society of Therapeutic Radiation and Oncology (ASTRO) definitions, at 5 years.~      During the prostate-specific antigen era, an ever-increasing percentage of men with prostate~     cancer have presented with clinically localized, potentially curable disease. Although~     conventional treatment options are potentially curative in selected patients, these~     treatments also have drawbacks, including the risk of negative long-term quality of life~     consequences and serious complications.~      The CyberKnife® system is a type of radiation machine that uses a special system to precisely~     focus large doses of x-rays on the tumor. The device is designed to concentrate large doses~     of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be~     minimal.~      Intermediate risk patients will be treated with either CyberKnife® Stereotactic Body~     Radiation Therapy (SBRT) monotherapy or CyberKnife® SBRT boost followed by Intensity~     Modulated Radiation Therapy (IMRT). High risk patients will be treated with CyberKnife® SBRT~     boost followed by IMRT. Treatment will last 4-7 days. Patients will complete the QOL~     questionnaires before treatment. Questionnaires will also be completed during follow-up~     visits at 1, 3 , 6, 12, 18, 24, 30 and 36 months then every 12 months until year 5.~   "
120837|NCT01985815|"~     In select, therapy resistent patients with Obsessive Compulsive Disorder (OCD) Deep Brain~     Stimulation (DBS) has been used as a treatment. DBS is a therapy modality in which electrodes~     are implanted within specific sub-structures of the brain in order to modulate the activity~     in targeted neural circuits associated with different neurological disorders. The results of~     this novel approach to psychiatric disorders have been optimistic. This study aims to~     investigate wether or not the distance to target location has an influence on the outcome.~      In order to deliver DBS, leads containing four electrodes are implanted into the brain target~     in the ventral capsule/ventral striatum (VC/VS). After an optimization period, patients enter~     a triple blind randomised two fazed crossover design of two periods of three months. In both~     crossover branches, patients, evaluating psychiatrist and psychologist are blinded for the~     stimulation conditions. These conditions are stimulation ON (at optimal parameters) and~     stimulation OFF. Stimulation parameters are constant during the entire period. During the~     second crossover branch, stimulation conditions are reversed for all patients.~   "
120838|NCT01985802|"~     The purpose of this study is to explore if there is a less harmful way to pace patients with~     first-degree AV-block to ensure that the negative effects inferred by the pacing do not~     outweigh the positive effects of AV-synchrony. The main hypothesis of the study is that~     His-bundle pacing will offer a more physiological mode of pacing in patients with~     first-degree AV-block than conventional pacing.~      Patients scheduled for catheter ablation of atrial fibrillation (AF) in sinus rhythm, with~     first degree AV-block, normal QRS duration less than 120 ms and normal left ventricular~     ejection fraction will be included. During the AF ablation three different pacing modes~     (atrial, AV-synchronous and His-bundle pacing) at two different rates (5 to10 bpm above the~     basal rate and at 100 bpm) will be performed and evaluated using echocardiography. After the~     completion of all six pacing protocols (i.e., three modes at two different rates) the~     experimental part of the procedure ends.~      The primary end-point will be echocardiographic evidence of dyssynchrony. Secondary~     end-points will include left ventricular ejection fraction, left ventricular volume, mitral~     regurgitation, septal to posterior wall motion delay and inter-ventricular wall motion delay.~     Since the research study is conducted in parallel with the standard catheter ablation, we do~     not anticipate any additional side effects as a result of the study.~   "
120839|NCT01985789|"~     The asthmatic airway is identified and studied using inhaled agents such as histamine and~     methacholine. The use of antihistamines prior to the test will inhibit the test result if~     histamine is used to cause airway constriction. If using methacholine, this may also be true~     depending on whether old (e.g. benadryl) or new (e.g. desloratadine) antihistamines are used.~     This study will look at the effect of old and new antihistamines on inhaled methacholine~     challenge response in individuals with mild asthma.~   "
120840|NCT01985776|"~     The first purpose of this study is to define parameters of the trunk neuromuscular functions~     that are pathologically altered in patients with low back pain due to spondylolytic~     spondylolisthesis. The second and also the main purpose of the study is to examine the~     effects of exercise intervention on patients with low back pain due to spondylolytic~     spondylolisthesis. Our overall hypothesis is that specific exercise intervention will improve~     neuromuscular functions of the trunk in patients with low back pain due to spondylolytic~     spondylolisthesis.~   "
120841|NCT01985763|"~     Colorectal neoplasms are the third most common malignancies in the United States. Patients~     with metastatic (stage IV) colorectal cancer have a median life expectancy of 2 years. The~     response rates to chemotherapy range from 35-40%.~      Epidemiologic evidence suggests that soy compounds may reduce the incidence of colorectal~     cancers. Laboratory analyses demonstrate that genistein, a soy-derived compound, may inhibit~     Wnt signaling, a pathway activated in majority of colorectal cancers. Laboratory observations~     also demonstrate that genistein may augment growth inhibition when combined with~     chemotherapeutic agents of 5-Fluorouracil and platinum compounds.~      Based on pre-clinical data the investigators hypothesize that combining genistein with the~     standard of care chemotherapeutic regimens will reduce chemotherapy resistance and improve~     response rates in patients. The aim of the study is to add genistein to the regimens of~     FOLFOX or FOLFOX-Avastin in patients with newly diagnosed stage IV colon or rectal neoplasms.~   "
120867|NCT01985425|"~     The purpose of this pilot study is to determine the feasibility of comparing colchicine to~     placebo for the prevention of new onset atrial fibrillation in patients undergoing general~     thoracic surgery and establish the foundation for a large, multi-centre, clinical trial.~   "
120868|NCT01985412|"~     The purpose of this study is to determine whether shotgun sequencing technology, which can be~     used to detect donor DNA in recipient plasma, can be used as a rapid, accurate, non-invasive~     method to detect Acute Cellular Rejection (ACR) after heart transplantation. Currently, all~     heart transplant recipients undergo invasive heart biopsies to diagnose ACR. Thus, there is~     an ongoing need to monitor patients for the development of acute and chronic rejection, with~     the primary goal of non-invasive early detection and treatment to prevent organ damage.~   "
120842|NCT01985750|"~     Dyspnoea is the uncomfortable shortness of breath that debilitates millions of patients with~     lung disease, heart failure and cancer. It is often very difficult to treat. The sensations~     of dyspnoea are processed in the brain, and we believe that psychological factors modify and~     amplify these sensations, frequently exacerbating symptoms.~      This study aims to identify the importance of learning in the brain mechanisms of dyspnoea by~     investigating a cohort of patients with chronic breathlessness undergoing pulmonary~     rehabilitation . Pulmonary rehabilitation is a six-week course of exercise, education and~     group therapy that improves dyspnoea but does not improve lung function. This leads us to~     hypothesise that some of the beneficial effects of PR maybe due to changes in brain~     processing, potentially relating to a learning effect.~      Therefore to probe whether learning is important in the beneficial effects of pulmonary~     rehabilitation, we intend to modify learning with the drug d-cycloserine. D-cycloserine is an~     antibiotic that enhances learning due to its effects at N-methyl D-aspartate (NMDA) receptors~     in the hippocampus. Our previous study in a similar group of patients demonstrated the~     importance of the hippocampus in breathlessness perception, and we now wish to investigate~     this in more depth.~      The study involves collecting physiological, psychological and clinical measures on in~     conjunction with brain scanning, before, during and once after pulmonary rehabilitation.~     Subjects will either receive d-cyloserine or placebo before the first four pulmonary~     rehabilitation sessions.~   "
120843|NCT01985737|"~     Percutaneously Inserted Central Catheters (PICCs) are special tubes that are inserted into~     blood vessels of premature babies (neonates) to give them nutrition and medications.~     Sometimes these tubes get infected and they need to be removed. Also, the babies need to be~     given medications to treat these infections (antibiotics). PICC infections in neonates are a~     serious problem and we need to find new ways of detecting infections early so that we can~     treat them promptly to avoid complications.~      The purpose of this study is to understand what causes tube infections in neonates and to~     develop a test to detect tube infections early to avoid complications.~   "
120844|NCT01985724|"~     In this trial investigators propose to assess the dose dense, G-CSF supported sequential~     administration of 4 cycles of FEC followed by 4 cycles of docetaxel versus 6 cycles of~     docetaxel/cyclophosphamide as adjuvant chemotherapy in women with HER-2 negative, axillary~     lymph node positive breast cancer~   "
120845|NCT01985711|"~     The goal of this proposal is to integrate depression services and diabetes care methods into~     a web-based collaborative care system so that a single program can assist patients with~     diabetes and co-morbid depression. The investigators hypothesized that the effect of the~     intervention program on (a) decreasing depressive symptomatology; (b) improving biomedical~     outcomes (e.g., blood lipid profiles,blood glucose, glycosylated hemoglobin, and blood~     pressure). (c) Increasing healthful behavior (medicine compliance, physical activity,~     diabetic diet);(d)decreasing unhealthful behavior( sedentary activities, smoking, alcohol~     addiction); (e) improving quality of life.~   "
120846|NCT01985698|"~     In this study, the investigators assessed the difference in efficacy and safety among~     robotic-assisted versus laparoscopic versus open abdominoperineal resection for patients with~     low rectal cancer.~   "
120847|NCT01985685|"~     The objective of this study is to determine the effect of thiamine therapy on oxygen~     consumption (VO2) in critically-ill patients. We will evaluate this by measuring VO2 before~     and after thiamine or placebo administration in patients admitted to the ICU and requiring~     mechanical ventilation. A secondary aim is to evaluate the effect of thiamine vs. placebo on~     the metabolic profile of the patients.~   "
120848|NCT01985672|"~     Vitamin D receptors are present and differently expressed in murine endometrium and ovary~     throughout the estrous cycle , whereas knock-out experiments have shown that vitamin D~     receptor null mice experience uterine hypoplasia and impaired folliculogenesis.~      Only few retrospective studies examining the role of vitamin D levels in infertile patients~     have been published up to date, whereas results are strongly contradictory, with some~     supporting that maternal vitamin D deficiency is associated with lower pregnancy rates and~     others demonstrating that vitamin D deficiency does not affect final reproductive outcome.~      Finally, a recent retrospective study postulated that vitamin D deficiency may negatively~     affect pregnancy rates with an effect mediated through the endometrium, given that vitamin D~     deficiency was not correlated with ovarian stimulation characteristics or with markers of~     embryo quality in this study.~      In order to examine a potential negative effect of vitamin D deficiency on pregnancy rates,~     mediated through the endometrium, the aim of the current study was to examine the impact of~     vitamin D levels on pregnancy rates only in an infertile population undergoing embryo~     transfer of frozen-thawed embryos.~   "
120849|NCT01985659|"~     This study investigates peropeative nodal upstaging during anatomical resections for~     non-small-cell-lung-cancer in an era of rising numbers of VATS anatomical resections. In case~     of comparable study groups, unchanged pretreatment staging and equal quality of pathologic~     examination, lymph node upstaging is a marker of surgical quality and can be used to study~     the quality of a new surgical technique.~   "
120850|NCT01985646|"~     The present study was designed to compare the efficacy of conservative treatment to operative~     treatment for improvement of constipation symptoms in infants with short or normal-segment~     Hirschsprung disease.~   "
120851|NCT01985633|"~     Osteoarthritis (OA) is one of the most common joint diseases.This disease commonly develops~     in the weight bearing joints of the lower limbs, such as the knee and hip joints.~     Osteoarthritis is considered a chronic degenerative disorder that is characterized by a loss~     of articular cartilage. Pathogenesis can involve all of the major articular tissues including~     cartilage, synovial membrane, subchondral bone and other connective tissues such as ligaments~     and tendons3. There is no effective therapy available today that alters the pathobiologic~     course of the disease.In view of vast role of platelet derived growth factors, mesenchymal~     cells and its safety, this prospective clinical trial is designed in an attempt to compare~     the efficacy of mesenchymal stem cells enhanced with platelet rich plasma in early stages of~     knee osteoarthritis.~   "
120852|NCT01985620|"~     Premature infants (born before 34 wk) are routinely vaccinated against RSV but vaccination~     rate against influenza are low in spite of national programs. Study goal is to evaluate the~     effectiveness of short intervention during RSV prophylaxis visit, planned to educate parents~     about the importance of influenza vaccination.~   "
120856|NCT01985568|"~     The primary aim of this study is to evaluate the extent to which an exercise intervention~     timed after diet-induced weight loss (rather than initiated at the same time) improves~     exercise adherence and long-term weight loss. An 18 month randomized trial will be used to~     compare two behavioral weight loss programs; standard behavioral therapy (Standard BT) and~     sequential behavioral therapy (Sequential BT). The Standard BT group will receive a~     traditional behavioral weight loss program where diet and exercise changes are initiated at~     the same time. The Sequential BT group will receive a program that focuses solely on dietary~     changes in the initial 6 months, and then incorporates exercise in the ensuing 6 months. Both~     groups will be followed for 18 months to assess long-term weight loss. The hypothesis is that~     delivery of diet and exercise interventions in sequence will result in improved adherence to~     exercise and weight loss at 18 months when compared to a traditional program in which~     identical diet and exercise interventions are initiated at the same time. This study could~     identify a strategy that could aid in the development of more effective obesity treatment~     programs and help more people achieve and sustain a weight loss.~   "
120857|NCT01985555|"~     The purpose of this study is to evaluate the safety and tolerability of single and multiple~     doses of volitinib administered to patients with locally advanced or metastatic solid tumors~     and determine MTD (Maximum Tolerated Dose) or RPTD(recommended Phase 2 dose).~   "
120858|NCT01985542|"~     Allergic rhinitis might be caused by decreased resistance of nasal barrier to allergens and~     other environmental insults. About 20 % of the European population suffers from pollen~     allergies. Birch pollen allergic rhinitis is the most common allergic disease in the~     Scandinavia and it exists widely also in the Central Europe. Suffering and high costs of~     pollen allergies may be reduced by understanding the molecular biology of the nasal barriers~     during allergic response. Our aim is to observe the effect of season and birch pollen~     immunotherapy on the molecular biology of nasal epithelium and the microbiome.~   "
120859|NCT01985529|"~     The effectiveness of clinic-based pulmonary rehabilitation in advanced Chronic Obstructive~     Pulmonary Disease (COPD) is well established, but few data exist for less severe patients~     treated in alternative settings. The purpose of this study was to investigate whether a~     novel, community-based exercise program was feasible and effective for patients with moderate~     COPD.~   "
120860|NCT01985516|"~     Currently, there are no specific guidelines or best practice suggestions for female~     catheterization. However, there is a consensus that an anesthetic lubricating gel should be~     routinely used in women as well.~      Urethral lubrication can be performed in two different techniques: instillation of the gel~     directly into the urethra or pouring the gel on the catheter's tip. In this study, we will~     evaluate the pain level during female urethral catheterization in each technique.~      Our hypothesis is that the level of pain will be much less if the lubrication agent will be~     instilled directely to the urethra.~   "
120861|NCT01985503|"~     In Turku PET Centre, there have been 3 positron emission tomography studies on brown adipose~     tissue (BAT) activity in healthy adults. BATPET was performed between 2008 and 2009. FATBAT~     started in 2011 and Dixon-BAT in 2012 and they are both currently ongoing. In the current~     study, participants of BATPET, FATBAT and Dixon-BAT studies are recruited for a follow-up~     study to examine associations between obesity, cardiovascular risk factors, serum metabolic~     profile and BAT structure at baseline and during follow-up several years later. 43 BATPET~     participants will be called for follow-up in 2013 with a follow-up period of 5 years and 52~     FATBAT and Dixon-BAT participants in years 2014 and 2015 with a follow-up period of 3 years.~     The aim of this study is to examine longitudinal associations between BAT function and~     structure, liver adiposity and cardiovascular risk factors at baseline and during follow-up.~   "
120862|NCT01985490|"~     Fovea is characterized by its vessel-free zone, called foveal avascular zone and it can be~     visualized by fluorescein angiography. Removal of epiretinal membrane and internal limiting~     membrane is frequently performed procedure and we suspected that these procedures may affect~     integrity of foveal avascular zone.~      The purpose of the present study is to evaluate the change of foveal avascular zone after~     removal of epiretinal membrane and internal limiting membrane~   "
120863|NCT01985477|"~     The goal of the Phase I portion of this clinical research study is to find the highest~     tolerated dose of the combination of lenalidomide, all-trans retinoic acid (ATRA), and~     dexamethasone that can be given to patients with relapsed or refractory multiple myeloma~     (MM).~      The goal of the Phase II portion of this study is to learn if ATRA when given in combination~     with lenalidomide alone or with lenalidomide and dexamethasone can help to control multiple~     myeloma.~      In September 2015, the study was terminated due to slow accrual while still a Phase I study,~     no additional registration or research performed under the Phase II portion of the study.~   "
120864|NCT01985464|"~     Allogeneic human umbilical cord tissue-derived stem cells will be injected intravenously once~     per day for 5 days is a safe and useful procedure in inducing remission of RA in patients~     resistant to standard DMARD therapy.~   "
120865|NCT01985451|"~     In this trial, we will treat relapsed PCNSL with temozolomide, pemetrexed. Our objective was~     to assess our treatment strategies' availability based on response rates, progression-free~     survival (PFS), median PFS, and toxicity.~   "
120866|NCT01985438|"~     Purpose:~      To compare the effect of prophylactic enteral feeding tube placement (either percutaneous~     endoscopic gastrostomy (PEG) tube or nasogastric (NG) tube) in patients undergoing treatment~     for head and neck cancer (HNC) on nutritional status, quality of life, mental and emotional~     health, rates of clinical complications, and cost of care.~      Study Design:~      Prospective randomized controlled trial with 2 arms and equal allocation ratio~      Study Objectives:~        1. The primary objective is to assess, among HNC patients randomized to receive either~          prophylactic PEG tube or NG tube for enteral support and who are undergoing~          chemo-radiation at SKMCH&RC, the change from baseline in nutritional status at the end~          of 24 weeks after treatment initiation.~        2. The secondary objectives are to assess, among HNC patients randomized to receive either~          prophylactic PEG tube or NG tube for enteral support and who are undergoing~          chemo-radiation at SKMCH&RC, the change from baseline in nutritional status at the end~          of 12 weeks; the rates of complications; quality of life including symptoms of~          depression and anxiety; and cost of care (all related to enteral feeding tube placement~          only) at baseline and at the end of 12 weeks and 24 weeks after treatment initiation.~      Patients and methods:~      Eligible patients will be enrolled consecutively from the gastroenterology outpatient clinics~     at Shaukat Khanum Memorial Cancer Hospital and Research Center (SKMCH&RC), Lahore and~     randomly assigned to receive either PEG tube or NG tube placement prior to commencement of~     treatment. Patients will receive counseling from a trained nutritionist regarding adequate~     nutrition during treatment and enteral feeding tube care. Detailed information regarding~     demographics, cancer location, type and staging, clinical status, nutritional status, quality~     of life, mental and emotional health, and cost of care will be obtained at baseline (time at~     which cancer treatment is initiated) and on 21st day (3 weeks), 42nd day (6 weeks), 84th day~     (12 weeks) and 168th day (24 weeks) after initiating chemoradiation. The primary endpoint~     will be to compare the nutritional status between the two treatment groups on an~     intent-to-treat basis on 168th day (24 weeks) after initiating chemoradiation.~   "
120869|NCT01985399|"~     Investigators hypothesize that older HIV-infected individuals (i.e., >50 years old) on~     efavirenz (EFV)-containing antiretroviral therapy (ART) will have significantly worse~     neurocognitive function than older individuals on non-EFV-containing ART.~   "
120872|NCT01985360|"~     The purpose of the ISCHEMIA-CKD trial is to determine the best management strategy for~     patients with stable ischemic heart disease (SIHD), at least moderate ischemia and advanced~     chronic kidney disease (CKD; estimated glomerular filtration rate [eGFR] <30 or on dialysis).~     This is a multicenter randomized controlled trial with 777 randomized participants with~     advanced CKD. Participants were assigned at random to a routine invasive strategy (INV) with~     cardiac catheterization (cath) followed by revascularization (if suitable) plus optimal~     medical therapy (OMT) or to a conservative strategy (CON) of OMT, with cath and~     revascularization reserved for those who fail OMT. The trial is designed to run seamlessly in~     parallel to the main ISCHEMIA trial as a companion trial.~      SPECIFIC AIMS~      A. Primary Aim. The primary aim of the ISCHEMIA-CKD trial is to determine whether an invasive~     strategy of cardiac catheterization followed by optimal revascularization, in addition to~     OMT, will reduce the primary composite endpoint of death or nonfatal myocardial infarction in~     participants with SIHD and advanced CKD over an average follow-up of approximately 2.8 years~     compared with an initial conservative strategy of OMT alone with catheterization reserved for~     those who fail OMT. The primary endpoint is time to centrally adjudicated death or nonfatal~     myocardial infarction (MI).~      B. Secondary Aims. Major: To compare the incident of the composite of death, nonfatal MI,~     resuscitated cardiac arrest, or hospitalization for unstable angina or heart failure; angina~     control per SAQ Angina Frequency Scale; disease specific quality of life per SAQ Quality of~     Life Scale between the INV and CON strategies. Other secondary aims include: comparing the~     incidence of the composite of death, nonfatal MI, hospitalization for unstable angina,~     hospitalization for heart failure, resuscitated cardiac arrest, or stroke; composite of~     death, nonfatal MI, or stroke; composite endpoints incorporating cardiovascular death;~     composite endpoints incorporating other definitions of MI as defined in the clinical event~     charter; individual components of the primary and major secondary endpoints; stroke and~     health resource utilization, costs, and cost effectiveness.~      Condition: Coronary Disease Procedure: Cardiac catheterization Phase: Phase III Condition:~     Cardiovascular Diseases Procedure: Angioplasty, Transluminal, Percutaneous Coronary, other~     catheter-based interventions Phase: Phase III Condition: Heart Diseases Procedure: Coronary~     Artery Bypass Surgery Phase: Phase III~   "
120873|NCT01985347|"~     The prevalence of anxiety and depression in our OSA population is more than in COPD and the~     general population of North West Adelaide. (principal hypothesis).~      CPAP therapy in OSA population produces a positive effect on the anxiety and depression~     scale.~      The Investigators intend to study the prevalence of anxiety and depression in patients with~     sleep disorders in comparison to patients with COPD and subsequently, to assess whether CPAP~     has a role in controlling anxiety and depression in depressed and anxious patients with sleep~     apnoea.~      This is a two phase study, in first phase; investigator will assess the prevalence of anxiety~     and depression, in a population with sleep disorders to check whether it is different to the~     prevalence in the COPD population. The prevalence of depression in Sleep Disorder population~     will also be compared with the Adelaide North Western general population, which was reported~     in The North West Adelaide Health Study. According to this epidemiological survey, which was~     conducted from 2008 to 2010, the prevalence of depression in Adelaide North Western general~     population was 20%.During the second phase of the study investigator will evaluate the effect~     of CPAP on anxiety and depression scores in the depressed and anxious patients with sleep~     apnoea by comparing the pre and post CPAP anxiety and depression status. The Hospital Anxiety~     and Depression (HAD) scale will be used to assess Anxiety and Depression, which is a~     well-documented tool for assessing symptoms of anxiety and depression in patients with~     somatic diseases.~   "
120874|NCT01985334|"~     The main goal of this study is to evaluate the efficacy and safety of glycopyrronium bromide~     and indacaterol maleate and glycopyrronium bromide fixed dose combination (FDC) in patients~     with moderate COPD who switch from their current COPD therapy. This study aims to provide~     data on how non-exacerbating, but still symptomatic patients with moderate COPD switching~     from their current COPD treatment to glycopyrronium bromide or indacaterol maleate and~     glycopyrronium bromide FDC maintain or improve their symptoms. Another purpose of this study~     is to increase awareness and usage of validated COPD symptoms tools and dyspnea~     questionnaires in order to facilitate clinical assessment and improve early diagnosis of~     symptomatic patients.~   "
120875|NCT01985321|"~     The purpose of this study is to determine if Merlin, a mixture of ethanol and glycolic acid,~     is safe and effective in the treatment of cold sores.~      Subjects who meet the requirements to participate in the study will be put randomly, and~     equally, into one of two groups: 1) a group receiving Merlin to treat their cold sore; or 2)a~     group receiving a placebo of just ethanol to treat their cold sore. Neither the subject nor~     the site will know which treatment they will be getting. Once the subject has been assigned~     to a treatment group, they will be given a kit containing a bottle of the treatment and~     special swabs to apply the liquid. The subject will be told to take the kit home and wait~     until they think they are starting to get a cold sore.~      Once a subject begins to feel something or see something that they think is the start of a~     cold sore, they are to immediately call the clinic. Once the clinic confirms that the subject~     is in fact starting to get a cold sore, the subject will be told to open the kit and begin~     treatment. From the start of treatment, there will be twelve (12) treatments, with either~     Merlin or placebo, applied six (6) hours apart, up to 3 per day, over the next 96 hours (4~     days). Each treatment of Merlin or placebo is made up of three (3) applications given twenty~     (20) minutes apart, for a total of thirty-six (36) applications. FOr each application, the~     subject will use the special swab to put the Merlin or placebo solution on their cold sore.~      Subjects will need to report daily to the clinic for a minimum of 3 consecutive days, until~     either the cold sore is completely healed or 14 days from the start of treatment, whichever~     comes first. At each clinic visit the cold sore will be observed to determine at what stage~     it is at or if it has healed. The subject will also be asked how they are feeling.~      Subjects will also be told to record in a diary the time of each application of Merlin or~     placebo. They will also be asked to record how much pain, if any, related to the cold sore,~     that they are feeling.~   "
120876|NCT01985308|"~     The purpose of this study is to show that a magnetic field applied to the front part of the~     brain of children suffering from Autism Spectrum Disorder(ASD) can improve function and~     ameliorate symptoms.~   "
120877|NCT01985295|"~     In this study, we aim to define the recommended dose of a VEGFR-TKI (pazopanib) in~     combination with RT pre-operatively given.~   "
120878|NCT01985282|"~     The study is to evaluate the feasibility of the NLA tool, a combined assessment of~     nutritional and physical functional status, to provide personalized advice for the~     independence and mobility of elderly.~   "
120879|NCT01985269|"~     M-DART Study is a randomized clinical trial comparing the effectiveness of a home-based~     modified directly observed antiretroviral (ART) treatment strategy to clinic-based standard~     of care in patients with HIV/AIDS in Port Victoria, Busia, Kitale, Chulaimbo and Khunyangu,~     Kenya.~      Hypothesis 1a: It is feasible to implement M-DART in remote, poverty stricken, high-HIV~     prevalence rural communities in western Kenya.~      Hypothesis 1b: M-DART will be a more effective strategy than standard of care (High-Risk~     Express Care) in reducing mortality and LTFU in patients at the highest risk of dying~     following ART initiation.~      Hypothesis 2: M-DART will be cost effective over the 48-week study period~      Hypothesis 3a: Patients enrolled in M-DART will have higher quality of life scores at 24 and~     48 weeks as compared to the control patients.~      Hypothesis 3b: Patients enrolled in M-DART will have lower HIV related stigma scores at 24~     and 48-weeks as compared to the control patients.~   "
120892|NCT01985100|"~     To confirm or refute recently published data regarding the reduction in post-stroke ischemic~     penumbra, that used SPECT/CT, by using the more precise tools of PET/MRI.~   "
120893|NCT01985087|"~     In this study we propose to determine outcomes of patients age 70 or older treated with~     radiation over 2 weeks given with temozolomide 75 mg/m2 daily during radiotherapy and as a~     post radiation treatment of 150 mg/m2 - 200 mg /m2 for 6 cycles or until the disease~     progresses.~   "
120880|NCT01985256|"~     This is a multicenter study evaluating the safety and tolerability of Toca 511 administered~     intravenously to patients with recurrent or progressive Grade III or Grade IV Gliomas who~     have elected to undergo surgical removal of their tumor. Patients meeting all of the~     inclusion and none of the exclusion criteria will receive an initial dose of Toca 511~     administered as an intravenous, bolus injection, followed approximately 11 days later by an~     additional dose injected into the walls of the resection cavity at the time of planned tumor~     resection. Approximately 6 weeks later, patients will begin treatment with oral Toca FC, an~     antifungal agent, and repeated every 4 weeks. All patients enrolled in this study will be~     encouraged to participate in a continuation protocol that enables additional Toca FC~     administration and the collection of long-term safety and response data.~   "
120881|NCT01985243|"~     Despite recent economic growth in Ghana, the prevalence of childhood malnutrition remains~     high. Wasting prevalence affected 29% among 6- to 8-months-old infants in 2008. Poor~     nutrition contributes to about one-third of child mortality, diminishes cognitive~     development, and is a major determinant of maternal mortality. The specific objectives of the~     5-year project are to: (1) enhance human capacity of government, civil, and private~     institutions through improvement of knowledge and skills of personnel in agriculture,~     nutrition and health, entrepreneurship, and pedagogy; (2) identify information needs of local~     institutions that are not presently met and develop a representative and sustainable~     longitudinal data system to support evidence-based decision-making in programs; (3) increase~     vulnerable households' access to quality services in agriculture/fisheries, nutrition and~     health, and finance; (4) implement integrated intervention activities to improve infant and~     young child and adolescent nutrition outcomes; and (5) examine differential benefits of the~     interventions for diverse vulnerable populations. The project comprises two major activities:~     part I - the creation of a longitudinal data system to support evidence-based decision-making~     in programs, and part II - the implementation of intervention activities to improve nutrition~     outcomes.~      The survey will include demographic, socioeconomic, health, diet, and nutritional status~     information collected annually from a representative same of 1500 households with infants~     (0-12 mo) and 1500 households with adolescents (9-12 y). The data will be analyzed and~     presented rapidly each year to district program and policy leaders to assist them in~     developing their activity plans for the following year.~   "
120882|NCT01985230|"~     The purpose of this Clinical Study is to investigate the effect of electrical stimulation for~     chronic low back pain.~   "
120883|NCT01985217|"~     Bacterial resistance to antimicrobials is an increasing problem. Doctors occasionally face~     genuine therapeutic dead-ends, when attempting to cure nosocomial infections and, more and~     more frequently, community-acquired infections. Mastering antimicrobial resistance diffusion~     is nowadays a major Public Health issue.~   "
120884|NCT01985204|"~     The study hypothesis is that iodine supplementation will lower serum TSH and leptin~     concentrations and thereby improve the lipid and glucose profile.~   "
120885|NCT01985191|"~     Primary Objectives:~      To determine the recommended Phase 2 dose of SAR405838 / pimasertib combination therapy in~     patients with solid tumors.~      To assess the anti-tumor activities of SAR405838 / pimasertib in patients with solid tumors.~      Secondary Objectives:~      To characterize the pharmacokinetic profile of SAR405838 and pimasertib.~      To evaluate the pharmacodynamic effect of the SAR405838 and pimasertib.~      To characterize genetic status in tumor tissue and circulating tumor DNA.~   "
120886|NCT01985178|"~     Eating disorders are conditions that are defined by abnormal eating habits that involve~     insufficient or excessive food intake. With regards to treating these disorders, there is an~     increasing interest in fat deprivation due to a lack of proper diet, particularly dietary~     fats such as polyunsaturated fatty acids. These fatty acids are essential components of the~     brain and are important for normal functioning of the body. Since the body cannot synthesize~     these fats, it has to rely completely on diet to obtain a sufficient amount. Hence, diets~     that lack sufficient fats or under fasting conditions, the imbalance of these fats can~     severely alter brain functions. The investigators want to see if these supplements are well~     tolerated and accepted by adolescent patients with eating disorders.~   "
120887|NCT01985165|"~     The purpose of this study is to evaluate the efficacy and safety of Imrecoxib in the~     treatment of patients with knee osteoarthritis.~   "
120888|NCT01985152|"~     The purpose of this study is to evaluate the Pharmacokinetics and safety of Azilsartan~     Trimethylethanolamine in healthy volunteers~   "
120889|NCT01985139|"~     Disturbances in hedonic and motivational processes play a major role in the pathophysiology~     of obesity. To date, experimental approaches for the study of emotional and motivational~     processing rely on subjective assessment scales. We have therefore developed two novel~     computer-generated tasks challenging respectively visual and temporal discrimination~     capacities for a quantitative and objective measurement of the hedonic and motivational state~     in humans. According to the task, the subjects are asked to view and to compare two stimuli,~     an appetitive one (food pictures) and its devalued counterpart (food pictures in greyscale),~     at each trial, assessing either the size (task A) or the duration of presentation (task B).~     From these considerations, the present project aims at using our novel tool to: i) assess the~     hedonic and motivational state in subjects with obesity, ii) compare their responses with~     healthy volunteers, and iii) establish relationships with biological markers known to be~     highly involved in the regulation of both emotional and motivational processes, such as~     endocannabinoids. The present project should demonstrate that the behavioral tests validated~     in our laboratory are relevant experimental tools for the diagnostic/clinical assessment and~     for the phenotypic characterization of obese patients. The application of the test in the~     therapeutic context could add further information about the efficacy and relevance of the~     chosen therapy. Finally, our project will provide information on the biological substrates of~     hedonic and motivational impairments that might become target of therapy in obesity.~   "
120890|NCT01985126|"~     The purpose of this study is to evaluate the efficacy and safety of 2 daratumumab treatment~     regimens in participants with multiple myeloma who have received at least 3 prior lines of~     therapy (including a proteasome inhibitor [PI] and immunomodulatory drug [IMiD]) or are~     double refractory to a PI and an IMiD.~   "
120894|NCT01985074|"~     The aim of the study is to determine whether a nurse-managed telephone-based case-management~     intervention can reduce healthcare utilization and improve self-assessed health status in~     frequent emergency department users.~   "
120895|NCT01985061|"~     Albeit the safety of the stem cell transplantation procedure has been greatly improved,~     further refining the intensity of the conditioning is an important issue to explore,~     especially in patients with poor prognosis, the goal being to maintain the very favorable~     safety profile and improve the disease control. This is the goal our prospective trial; we~     aim to prospectively evaluate in a prospective multicenter trial the efficacy of different~     conditioning regimens in patients with high-risk myeloid malignancies.~      The study is a phase II trial randomizing patients between a prospective active control arm~     (BX2) and two experimental arms (BX3 and BX4). A standard group was kept in this clinical~     trial in order to avoid the limitations induced by the comparison with historical controls in~     the context of continuously improving practice. Each experimental arm will be conducted in~     parallel according to a standard phase II trial design.~      In addition, this trial will associate four ancillary studies to the main clinical objective:~     1/ a prospective assessment of the quality of life of the patients over a period of 2 years~     2/ an analysis of the cost effectiveness of the procedure, assessed over a period of 2 years~     3/ an observational busulfan pharmacokinetic study 4/ a busulfan pharmacogenomic study~   "
120896|NCT01985048|"~     1. Primary Objectives:~             -  To characterize cardiometabolic risk factor profiles of patients entering cardiac~               rehab using traditional approaches (eg LDL-C) as well as a more comprehensive panel~               of cardiovascular and metabolic biomarkers. It is hypothesized that the~               comprehensive panel will identify further increased risk that would not have been~               detected using only traditional approaches. Specifically, it is hypothesized that a~               greater percentage of the cohort will be identified with high risk levels of~               LDL-P (>1100 nmol/L) and/or apoB (>80 mg/dL) than of LDL-C (>100 mg/dL). It is~               further hypothesized that the prevalence of elevated Lp(a) and elevated levels of~               inflammatory and insulin resistance markers will be higher in this cohort when~               compared to population norms (HDL, inc reference data).~             -  To assess improvements in laboratory and lifestyle risk factors and rate of goal~               attainment at completion of rehab (eg 3 months). This objective is primarily~               descriptive, and improvements in traditional risk factors (eg LDL-C) will be~               compared to existing published data. Improvements in non-traditional risk factors~               (eg LDL-P, insulin resistance markers) in a cardiac rehab population have not been~               extensively investigated.~             -  To determine which attributes at baseline best predicted recurrent events and~               re-hospitalizations assessed one year later.~        2. Secondary/Developmental Objective:~             -  To inform and guide development of a subsequent study protocol designed to compare~               outcomes associated with biomarker-guided personalized treatment plans vs. standard~               of care in the cardiac rehab setting.~   "
120897|NCT01985035|"~     Obstructive sleep apnea (OSA) can impars body weight reduction by changes in body composition~     and energy expenditure. The objective of this study is to evaluate the influence of OSA in~     energy metabolism and body mass loss in obese subjects. Ninety obese volunteers of both~     genders, 45 diagnosed with OSA and 45 without OSA, will be submitted to a dietary~     intervention of one months. Volunteers will be distributed into four groups: obese OSA PTN~     with moderate protein diet (1.6 g / kg protein / day), obese OSA CHO diet (0.8 g / kg protein~     / day) with standard composition diet, obese NSAOS PTN diet moderate in protein and CHO NSAOS~     obese standard diet. All groups will be instructed to perform a restricted energy diet (less~     30% of daily energy expenditure). At baseline and one month after the beginning of the~     program the following evaluations will be conducted: total energy expenditure measured by~     doubly labeled water method, resting energy expenditure and thermic effect of food by~     calorimetry, polysomnography analysis, body composition by pletysmography, food consumption~     by three days of food diary, blood collection for analysis of lipid profile, visceral~     proteins, hormones related to control of body weight and inflammation. As hypothesis we~     believe that apneic obese individuals have greater difficult in weight loss and loss more~     free fat mass than the obese no apneic and that diets with more protein can contribute to~     greater weight loss, better body composition and energy expenditure in these population.~   "
120898|NCT01985022|"~     The major purpose of this study is to directly compare two parent intervention conditions for~     children diagnosed with autism spectrum disorders at 18 months of age to document the~     effectiveness.~   "
120899|NCT01985009|"~     The non-alcoholic fatty liver disease (NAFLD) represents the most common cause of liver~     disease in the western world. It can progress from steatosis to non-alcoholic steatohepatitis~     (NASH), and then onto cirrhosis where there is a concomitant risk of developing~     hepatocellular carcinoma (HCC). The prevalence of hepatic steatosis is high, ranging from 16~     to 31% in the general population, up to 80% in the obese populationand up to 96% in severely~     obese patients.~      Liver biopsy (LB) has traditionally been regarded as the gold standard for the assessment of~     patients with NAFLD, although it has several limitations. LB has a potential sampling error,~     is an invasive and often painful procedure.~      The natural history of patients with NAFLD is generally determined by the extent of liver~     fibrosis, hence non-invasive assessment of fibrosis with FibroScan® is often sufficient. For~     patients with proven NASH, changes in hepatic steatosis and serum ALT levels may provide~     information on the patient's course and/or response to treatment.~      Several clinical studies have shown the benefit of measuring hepatic stiffness with the~     FibroScan® machine using the M+ probe. The ability to identify significant fibrosis and~     cirrhosis has been demonstrated in normal and overweight patients affected with chronic~     hepatitis B and C, biliary diseases, alcohol related liver disease (ALD) and NAFLD.~      Recently, Echosens has also developed a novel ultrasonic controlled attenuation parameter~     (CAP) designed to quantify hepatic steatosis using a process based on vibration controlled~     transient elastography (VCTE™). Studies comparing CAP with liver biopsies in multi-aetiology~     cases and patients with Hepatitis C Virus (HCV) have shown that there is a good correlation~     between steatosis assessed histologically and using CAP.~      The main objective of this prospective study is to evaluate the diagnosis accuracy of the~     Controlled attenuation Parameter (CAP) measured by FibroScan® (either with M+ or XL+)in~     patients with NAFLD to assess liver steatosis using biopsy as a reference.~      The study involves adults' patients with suspected NAFLD scheduled to have a liver biopsy~     within 2 weeks of fibroscan examination and followed by the Hepatology service of four~     centers in United Kingdom.~      Approximately 450 patients (of which 350 will be evaluable) will be enrolled in this study:~     Around 100 patients will be measured with the M+ probe and around 250 with the XL+ probe.~      The inclusion period is from 18 to 24 months. Starting date: January 2014. End of~     recruitment: June 2017. The duration of the study for a patient is from 1 to 7 days,~     depending to the exams calendar.~   "
120900|NCT01984996|"~     The primary objective of this study is to evaluate patient quality-of-life (QOL) after~     inguinal hernia repair. Carolinas Comfort Scale (CCS) assessments will be held at regular~     intervals.~      The secondary objective of the study is to follow short-term and long-term study-related~     complications/adverse events.~   "
120924|NCT01984684|"~     The purpose of this study is to evaluate the effects of Delafloxacin versus Vancomycin plus~     Aztreonam in the treatment of patients with acute bacterial skin and soft tissue infections.~   "
120901|NCT01984983|"~     The Phase I study will assess the basic safety, tolerability, and immunogenicity of a~     DNA-based Venezuelan equine encephalitis virus (VEEV)vaccine candidate delivered by~     electroporation . The study will enroll 40 healthy adult volunteers ages 18-49 and will~     comprise evaluation of intradermal or intramuscular administration by electroporation.~     Administration of the vaccine candidate will be at two DNA dose levels (0.5 mg/ml and 2.0~     mg/ml) for each route of administration. Electroporation will be administered using the~     TriGrid Delivery System devices for intramuscular and intradermal delivery. An additional~     group of subjects will serve as a placebo control, receiving injections of saline with~     electroporation. The overall goal of this study will be to determine if further human~     clinical studies of the vaccine candidate are warranted and, if so, to aid in the selection~     of dose and route of administration for future studies.~   "
120902|NCT01984970|"~     1. Double-lumen tube intubation is difficult, compared with single lume tube.~        2. McGrath Series 5 videolaryngoscope hase been used in difficult airway management, both~          in anesthetized and awake patients.~        3. But there was little information about McGrath Series 5 videolaryngoscope for~          double-lumen tube intubation.~   "
120903|NCT01984957|"~     To isolate biomarkers of ALS in muscle~   "
120904|NCT01984944|"~     Autism spectrum disorders (ASDs) are complex neurodevelopmental conditions characterized by~     deficits in social communication, delay in language and repetitive behaviors. Results from~     genetic studies reveal one pathway associated with susceptibility to ASDs, which includes~     synaptic cell adhesion molecules. Among the factors that could modulate this pathway are the~     genes controlling circadian rhythms. Sleep disorders and low melatonin levels are frequently~     observed in ASDs. Thus investigator will characterize the circadian rhythms of patients with~     ASD and search for circadian rhythms genes polymorphisms.~   "
120905|NCT01984931|"~     This study will determine if giving Trimebutine Maleate (NEWBUTIN SR 300 mg Tab)orally will~     be effective as a prophylactic anti-emetic drug for patients who underwent arthroscopic~     rotator cuff repair under general anesthesia.~   "
120906|NCT01984918|"~     To conduct a prospective randomized controlled study to identify predictors for colonoscopy~     non-attendance and examine the efficacy of SMS reminder to improve the non-attendance rate.~   "
120907|NCT01984905|"~     Clinical outcomes of chronic type B aortic dissections are unknown, especially in case of~     false lumen expansion and risk of rupture. Data of literature give us some indications about~     prognosis. The 1-year survival rate is about 80%, but we deplore the 25% rate of mortality at~     3 years despite follow-up.The only known predictive factors are the initial diameter of more~     than 4 cm and the persistence of a false lumen patent.However, actual means of follow-up do~     not allow to predict severe complications. The aim of the sudy is to propose a diagnostic and~     preventive strategy for the follow-up of chronic type B aortic dissections treated medically.~      The primary objective is then to evaluate the prognostic role of 18-FDG-PET Scan in such~     patients in order to predict the risk of aortic diameter growth of more than 5 mm in 1 year~     and/or of an aortic dissections extension at 1 year. The secondary objectives are to evaluate~     the link between fibrosis biomarkers MMP et TIMP) and the results of imaging results~     (evolution of diameter and extension and results of PET-Scan imaging) Methods: 100 patients~     to be included in 3 years History of chronic type B aortic dissection, treated medically,~     evolving since more than 1 month and less than 5 years.~      Expected results: Prognostic contribution of 18FDG-PET-Scan and biomarkers for the~     identification of patients at high risk of evolution. Elaboration of a decisional algorithm~     about follow-up modalities of chronic aortic dissections. Demonstration of a correlation~     between aortic diameter growth or aortic dissection extension and intensity of marker~     fixation with 18-FDG-PET-Scan.~   "
120908|NCT01984892|"~     The purpose of this study is to test the safety of a course of injections containing~     Poly-ICLC in patients with advanced solid tumors that can be easily and safely reached with a~     needle.~      Poly-ICLC is a compound that has been used to help the body in its fight against cancer.~   "
120909|NCT01984879|"~     The purpose of this study is to investigate the vaccination status, knowledge about~     vaccination, and attitude to vaccination of the Korean patients with inflammatory bowel~     diseases~   "
120910|NCT01984866|"~     This project aims to determine whether biopsy using radiofrequency is a procedure suitable~     for this patient selection. Findings from biopsy will be correlated with the conventional~     surgery ones. If the technique is validated to predict the presence or absence of residual~     tumor, breast surgery could be avoided in cases of absence of tumor.~   "
120911|NCT01984853|"~     This is an OBSERVATIONAL Specimen procurement and data collections trial for acute coronary~     syndrome that will be conducted in the Emergency Department at Henry Ford Hospital.~      The standard protocol for evaluating patients in the Emergency Department for possible acute~     myocardial infarction includes the measurement of cardiac troponin over 3 hours. Subjects~     presenting to the ED with chest discomfort or ischemic symptoms will be eligible for blood~     draw protocol. The study is blinded to treating physicians and does not change current~     standard of care. After informed consent patients will have blood samples drawn at 0, 30~     minutes, 1 hour and 3 hours.~      Serum from the samples will be stored in a -80 research freezer to be evaluated at a later~     time as new cardiac markers for acute coronary syndrome are developed.~   "
120912|NCT01984840|"~     There are two main aims in this study. The first objective is to evaluate whether a~     particular telehealth solution, in addition to standard treatment and care, lead to a~     significant decrease in the mortality and an increase in health related quality of life for~     patients suffering from COPD that may benefit from telehealth compared with only standard~     treatment and care. The second objective is to examine the additional costs of the telehealth~     solution and assess whether this solution is a cost-effective way to care for patients with~     COPD across patients and municipality districts.~      It is hypothesized that telehealth care will increase patients quality adjusted life years at~     both the cluster and individual level compared to usual practice, since no difference in~     mortality and a higher health related quality of life is expected. Furthermore, it is hoped~     that there will be a 30% reduction in the number of admissions and readmissions to hospitals~     and a 30% reduction in the number of outpatient visits resulting in fewer costs for~     hospitals. However, it is uncertain as to whether these savings are offset by other costs~     such as more visits to general practitioners, community care or the implementation costs.~   "
120913|NCT01984827|"~     High blood glucose levels (hyperglycaemia) and Moxifloxacin (a commonly used antibiotic) have~     both been shown independently to affect heart activity in healthy volunteers as recorded by~     ECG. i.e. Both cause prolongation of the QTc interval which is a measure of the time between~     the start of the Qwave and the end of the Twave during a heartbeat cycle. In this study, the~     investigators want to find out whether moxifloxacin and hyperglycaemia cause QTc prolongation~     in Type 1 diabetic patients. The investigators also want to assess whether C-peptide (a~     fragment if insulin normally found in the blood but not present in not present in the blood~     of Type 1 diabetics) which has the opposite effect on heart activity i.e it shortens the QTc~     interval will reverse the effect of QTc prolongation in Type 1 diabetes as this may be useful~     for preventing 'dead in bed' syndrome also known as 'Sudden Cardiac Death' which is more~     common in diabetic patients compared to healthy volunteers.~   "
120914|NCT01984814|"~     The effect of autologous bone marrow mononuclear cells on duration of survival in Amyotrophic~     Lateral Sclerosis patients.~   "
120915|NCT01984801|"~     The proposed indication for GSK1940029 is topical treatment of acne, the early clinical plan~     will evaluate the irritation potential of GSK1940029 (Study SCD117225 - 3 Part study); and~     safety, tolerability and pharmacokinetics of GSK1940029 (Study SCD117226 - 2 Part study),~     after topical administration on healthy subjects and acne patients. Study SCD117225 will be a~     randomized, single-blind, three part study, to evaluate the primary irritation potential~     (Part 1), cumulative irritation potential (Part 2) of two concentrations of GSK1940029 gel~     applied to the intact skin of healthy subjects, and the facial irritation potential of one or~     two concentrations of GSK1940029 applied to the face of acne patients (Part3). In Part 1 and~     Part 2 the following 6 treatments will be applied using individual patches: (A) 200~     milligrams (mg) of 0.3% GSK1940029 gel, (B) 200 mg of 1% GSK1940029 gel, (C) 200 mg of~     0.3%/1% vehicle gel only (vehicle control), (D) 200 microliters (µL) of sterile distilled~     water (negative irritant control), (E) 200 µL of - 0.5% sodium lauryl sulfate (SLS) in~     sterile distilled water for Part 1/0.1% SLS in sterile distilled water for Part 2 (positive~     irritant control), and (F) Patch only (patch control). Each treatment will be randomized to~     one of six designated locations on either upper arm or other locations, such as the lower or~     upper back, within each subject. The same treatment will be reapplied to the same location on~     subsequent days. Each treatment will be applied daily for 2 days in Part 1, and daily for 21~     days in Part 2. In Part 3, each patient will apply a thin coat of one or two concentration of~     GSK1940029 gel or vehicle to acne affected facial/neck skin by hand, once daily for 28 days.~     Parts within Study SCD117225 and Study SCD117226 will have interdependencies. No significant~     primary irritation signal in Study SCD117225 Part 1 would allow initiation of Study SCD117226~     Part 1 (single dose application). Once safety, tolerability and exposure information are~     determined in Study SCD117226 Part 1, Part 2 of Study SCD117225 may be initiated along with~     Part 2 (14-day repeat dose application). No significant cumulative irritation signal (study~     SCD117225 Part 2) in combination with adequate 14-day safety (study SCD117226 Part 2) would~     allow initiation of Part 3 of Study SCD117225.~   "
120916|NCT01984788|"~     The purpose of this study is to determine whether BCX4161 given as a daily oral prophylactic~     treatment is safe and effective in reducing the number of acute attacks in patients with~     hereditary angioedema.~   "
120917|NCT01984775|"~     This study is conducted to assess the potential of topically-applied GSK2894512 cream at 3~     concentrations (0.5%, 1%, and 2%) to induce skin irritation at the site of application in~     healthy subjects. Results from this study will be considered when selecting the~     concentration(s) of GSK2894512 to evaluate in the Phase II and Phase III clinical safety and~     efficacy studies. Approximately 40 subjects will be enrolled in order to have at least 30~     evaluable subjects complete the study. The total duration of subject participation may be up~     to 50 days.~   "
120918|NCT01984762|"~     Obesity is a growing epidemic throughout the world and is followed by increasing incidence of~     type 2 diabetes that accounts for 90-95% of all cases of diabetes. Weight loss is a major~     objective, although difficult to achieve with medical treatments. Many recent studies~     demonstrated that bariatric surgery has the potency to achieve marked and sustained weight~     loss, and is also associated with a significant improvement in control of type 2 diabetes.~     The principal aim of this study is to compare two types of bariatric procedures, the~     Roux-en-Y gastric bypass (RYGBP) and sleeve gastrectomy (SG). The study hypothesis is that~     these procedures have equal efficacy with regard to resolution of type 2 diabetes.~   "
120919|NCT01984749|"~     The purpose of this study is to demonstrate the effect of febuxostat in preventing cerebral~     and cardiorenovascular events in elderly patients with hyperuricemia who are at risk for~     cerebral and cardiorenovascular disease.~   "
120920|NCT01984736|"~     The purpose of this study is to assess the pharmacokinetics of EVP-6124 and metabolites after~     a single oral dose in subjects with mild, moderate and severe hepatic impairment compared~     with subjects with normal hepatic function.~   "
120921|NCT01984723|"~     The purpose of this study is to assess the pharmacokinetics of EVP-6124 and metabolites after~     a single oral dose in subjects with mild, moderate and severe renal impairment compared with~     subjects with normal renal function.~   "
120922|NCT01984710|"~     Major depressive disorder is a common disease. For many people, conventional treatments such~     as antidepressants are very helpful in relieving the symptoms of this condition. But as many~     as 30% of patients with depression have less than a full response or become resistant to~     conventional treatments. When treatment resistance develops, the depression becomes a chronic~     disease with a very significant burden of morbidity and mortality. The reasons that some~     patients develop Treatment Resistant Depression (TRD) are not known. One current theory for~     depression is that it results from the dysfunction of a network of regions in the brain and~     that in treatment resistant patients the network is permanently stuck in the dysfunctional~     state. We have been investigating an experimental treatment for treatment resistant~     depression (TRD), based on this network theory known as subcallosal deep brain stimulation~     (SCC DBS). This treatment involves placement of electrodes in a specific region of the brain~     (subcallosal cingulate cortex, area 25) and then stimulating that area with electricity,~     which resets the regulation of the network resulting in a significant antidepressant~     response. While still experimental our results suggest this may eventually be a useful~     treatment for some patients with TRD. The experiment described in this application is to use~     a new DBS device that can record the electrical activity in the brain around the site of~     stimulation. The electrical activity is known as Latent Field Potential (LFP) and is a~     reflection of the activity if the neural network. The new DBS device is an experimental~     device that has not been approved by the Food and Drug Administration (FDA), but allows for~     simultaneous recording of LFP while stimulation is being delivered. The device is~     manufactured by Medtronics and is known as Activa Primary Cell + Sensing(PC+S), but because~     it can be used to record the brain electrical activity it is also known as the Brain Radio.~     The Brain Radio is based on an approved device commonly used for DBS for other conditions~     that has the added sensor capacity. The stimulation system is identical to that in the~     approved device. The goal of this investigation is to use the Brain Radio to study LFP in the~     brains of people with TRD before and during active stimulation. The ultimate goal is to~     understand the neural network that causes TRD and the changes that DBS cause in that network~     that results in the antidepressant effects. We will recruit 10 patients with advanced TRD and~     implant them with the Brain Radio system. The recording system will be to record LFP over 3~     years, while patients receive stimulation. A brief discontinuation study will be conducted~     after 6 months of stimulation when the device will be turned off and patterns of LFP changes~     will be recorded. All LFP measures will be correlated with the primary clinical response~     outcome metric, the Hamilton Depression Rating Scale. The knowledge gained with this~     experiment will be invaluable to understanding the basic pathology of depression and the~     antidepressant response. This is a unique, first in humans test of this device and as such~     the results are expected to impact our understanding of depression at a fundamental basis.~   "
120923|NCT01984697|"~     This study is a 37-month safety and immunogenicity study conducted in boys and girls 9 to 14~     years of age and in young women 16 to 26 years of age. From this study, the goal is to~     establish that the investigational 2-dose regimens (0, 6 months and 0, 12 months) studied in~     boys and girls 9 to 14 years of age are generally safe and immunogenic, with an antibody~     response that is not inferior to that observed in young women 16 to 26 years of age who~     received the standard 3-dose regimen of V503 (i.e., the population and dose regimen used to~     establish V503 efficacy).~   "
120925|NCT01984671|"~     Persistent pain is a major challenge for patients who undergo hematopoietic stem cell~     transplant (HSCT) and is related to more fatigue, more physical disability, poorer quality of~     life, and poorer medical adherence. There is a need to examine strategies for managing pain~     in HSCT patients that can complement existing analgesic regimens. Strong evidence suggests~     that cognitive and behavioral factors play an important role in HSCT patients' ability to~     manage their pain. The investigator has found that HSCT patients having low levels of~     confidence (i.e., self-efficacy) in their ability to control pain and high use of maladaptive~     coping strategies (i.e., pain catastrophizing) experience increased pain and disability. A~     psychosocial intervention that modifies patients' cognitive and behavioral pain coping~     strategies may benefit HSCT patients. Protocols, particularly Pain Coping Skills Training~     (PCST), have been developed for reducing pain and improving quality of life in patients with~     persistent pain. However, HSCT patients with persistent pain face a number of unique~     challenges that must be considered when applying a PCST protocol. The investigator proposes~     to develop and test a Mobile Health Pain Coping Skills (mPCST) protocol for HSCT patients~     with persistent pain to meet the challenges of HSCT patients with pain as they transition~     from hospital based care to their home environment. The first aim of this study is to use an~     iterative development model to design a mPCST intervention protocol for HSCT patients that~     targets increasing self-efficacy for pain control and decreasing pain catastrophizing. The~     study team will use focus groups with patients and HSCT providers to guide development along~     with user testing with HSCT patients having pain. The second aim of this study is to use a~     small randomized controlled trial to examine the feasibility, acceptability, and engagement~     in the developed mPCST protocol. The third aim is to obtain an estimate of the effect size of~     the developed mPCST protocol on decreased pain, pain disability, physical disability, and~     adherence to post-transplant lifestyle recommendations impacted by pain when compared to a~     standard care control condition. Proposed innovative features of the mPCST protocol that will~     be developed include: extensive input from PCST and HSCT experts and HSCT patients with pain;~     an initial session prior to discharge with subsequent sessions occurring at home via~     video-conferencing; incorporation of strategies to decrease the impact of pain on adherence~     to critical post-transplant lifestyle recommendations; a real-time daily assessment system~     with subsequent tailored feedback. If the developed mPCST protocol demonstrates feasibility,~     acceptability, engagement, and promising effect sizes to influence pain and other indices of~     quality of life, a larger NIH grant will be sought to examine this protocol in a larger~     sample of patients, test the protocol against an active treatment, and investigate a broader~     array of outcomes (e.g., medication adherence). This mPCST protocol could also be examined in~     other patient populations with pain facing similar challenges (e.g., live far from medical~     center, travel limitations).~   "
120926|NCT01984658|"~     This study is a prospective open phase-I study to investigate the safety and tolerability for~     administration of repeated doses of ALECSAT.~      Each patient will be followed up to 24 weeks from the initial blood donation to the last~     visit. However, the actual treatment starts on day 26, when the first single dose of ALECSAT~     is administered. The following administrations are given with 3 weeks intervals, i.e. at week~     7 and 10. The patients are attending Kirurgisk afdeling K, Bispebjerg Hospital, and are~     followed by close examinations during the study period and at regular visits after completing~     the study as advised by the patient's responsible physician.~   "
120927|NCT01984645|"~     New York-Presbyterian Hospital has created a system that notifies its primary care providers~     whenever their patients are admitted to the hospital. In this study, the investigators want~     to evaluate how accurate this system is and how it is affecting the primary providers and~     their health care delivery.~   "
120928|NCT01984632|"~     The aim of this study is to test our hypothesis that the use of unidirectional knotless~     barbed suture in single-port laparoscopic myomectomy could facilitate the suture of uterine~     wall defect after myoma enucleation as multi-port laparoscopic myomectomy did.~   "
120929|NCT01984619|"~     To evaluate the safety and effectiveness of the iovera° device with the blunt tip cannula for~     the treatment of forehead wrinkles.~   "
120930|NCT01984606|"~     The purpose of this study is to assess safety and efficacy of empagliflozin compared to~     sitagliptin in patients with type 2 diabetes mellitus who are treatment-naive or on treatment~     with metformin and have insufficient glycaemic control. The study will assess non-inferiority~     of empagliflozin to sitagliptin with regards to HbA1c.~   "
120931|NCT01984593|"~     The purpose of this study is to determine the effects of a short yoga program practiced daily~     at home on blood pressure, quality of Life and stress. The subjects of the study are primary~     health care patients diagnosed with hypertension, with or without current medication.~   "
120932|NCT01984580|"~     Using orally administered zinc to patients already diagnosed with the pre-cancerous~     condition, Barrett's Esophagus, this study is asking two questions:~        1. can this zinc administration cause molecular-level changes in the Barrett's tissue?~        2. are the changes measured indicative of chemopreventive action by zinc regarding cancer~          progression?~   "
120933|NCT01984567|"~     Background of the study:~      We now know that plant sterols can oxidize, which results in the formation of~     oxyphytosterols. Animal studies have suggested that oxyphytosterols are atherogenic~     components, however this relation has not yet been studied in humans. In our previous study~     (METC 09-3-088) we have shown in healthy volunteers that serum oxyphytosterol concentrations~     are linked to oxidative stress status (i.e. we were able to identify high and low sterol~     oxidizers). From the literature is known that especially type II diabetics and IGT subjects~     are characterized by increased oxidative stress markers and reduced antioxidant capacity. For~     this reason we also want to evaluate the oxyphytosterol concentrations in this population.~     Moreover, we know propose to evaluate the effect of antioxidant supplementation, i.e. vitamin~     E or lipoic acid, on serum oxyphytosterol concentrations in type II diabetic patients. If~     possible to lower oxyphytosterol concentrations in these populations this is obviously~     beneficial in case oxyphytosterols turn out to be atherogenic. The major objective of the~     present study is to examine the effect of consuming vitamin E (804 mg) or lipoic acid (600~     mg) for 4 weeks on fasting oxyphytosterol concentrations in subjects with impaired glucose~     tolerance or type 2 diabetes.~   "
120934|NCT01984554|"~     The primary objective of this study is to compare the total costs to sites and payers of~     administering IV iron over the 30-day observation period for subjects with IDA who receive~     Ferric Carboxymaltose (FCM) relative to those who receive iron sucrose, iron dextran, and~     ferumoxytol.~   "
120935|NCT01984541|"~     The objective of this study is to determine the biological activity of Artemisia vulgaris~     allergen extract in histamine equivalent units (HEP) units, in order to be used as in-house~     reference preparation (IHRP).~   "
120936|NCT01984528|"~     The objetive of this study is to determine the minimum amount of Alternaria alternata~     allergen extract producing in a positive skin reaction.~   "
120937|NCT01984515|"~     The purpose of this study is to implement an evidence-based Referral Management System that~     will address patient and system-level barriers to the uptake of evidence-based psychotherapy~     for PTSD by Veterans Affairs primary care patients.~   "
120938|NCT01984502|"~     The feasibility of reducing fractions in early-stage laryngeal cancer has not previously been~     prospectively studied, and we will therefore conduct a careful phase I bio-equivalent dose~     fraction reduction study.~   "
120939|NCT01984489|"~     SHR117887 is a new dipeptidyl peptidase(DPP)-4 inhibitor. This study aims to evaluate the~     efficacy and safety of SHR117887 in combination therapy with Metformin in patients with Type~     2 Diabetes in Metformin monotherapy Who have Inadequate Glycemic Control~   "
120940|NCT01984476|"~     As the spinal cord injured population ages, these individuals are being exposed to an~     increased prevalence of age-associated diseases, which coupled with the secondary~     complications of the injury may contribute to the reduced life expectancies. Decentralized~     autonomic regulation in persons with SCI results in a multitude of cardiovascular changes,~     which may contribute to accelerated aging. Adverse cardiovascular changes may have~     deleterious effects on cerebral blood flow dynamics and an increase in cerebral vascular~     resistance index in individuals with SCI during cognitive testing. Deficits in memory and~     processing speed in individuals with SCI may relate to cardiovascular and cerebrovascular~     dysfunction. Identifying the associations between healthy aging versus premature or~     accelerated aging in organ system function in the SCI population is an important first step~     towards prevention and amelioration of these changes. Therefore the study objectives are to~     compare, among individuals with SCI, age-matched non-SCI and older non-SCI individuals~     arterial stiffness and cerebral vascular resistance index; memory, processing speed, and~     executive function; and volume of white matter hyperintensities. 60 individuals with SCI, 30~     age-matched non-SCI controls, and 20 older non-SCI controls will be recruited for this study.~     All potential subjects will undergo a two-part screening process which consists of an initial~     screening via telephone and a detailed, in-person screening. Eligible subjects will be~     invited to participate in a 4 hour laboratory visit during which their arterial stiffness,~     blood pressure, heart rate, respiration rate and, blood flow to the brain will be monitored~     at rest and during a comprehensive series of cognitive tests. A subset of the participants~     will be asked to take part in an MRI brain imaging session: 40 persons with SCI, 10~     age-matched non-SCI and 10 older non-SCI. Eligible subjects will be asked to participate in a~     1 hour MRI/functional magnetic resonance imaging(fMRI) session.~      We hypothesize that arterial stiffness and cerebral vascular resistance index will be~     increased in the SCI group compared to the age-matched non-SCI but will be comparable to the~     older non-SCI groups. In addition, we hypothesize that the prevalence of mild to moderate~     cognitive impairments in memory, processing speed, and executive function will be increased~     in the SCI individuals compared to the age-matched non-SCI but will be comparable to the~     older non-SCI individuals.~   "
120941|NCT01984463|"~     This study is designed to assess the impact of epidural morphine on:~        -  The incidence and severity of shoulder pain following a thoracotomy.~        -  The need for additional analgesics, such as opioids for the relief of shoulder pain.~        -  Its safety profile compared to epidural fentanyl following a thoracotomy.~      The basic hypothesis of this study is that an infusion of epidural bupivacaine and morphine~     initiated after the induction of anesthesia and continued until 72 hours postoperatively will~     reduce the incidence and severity of shoulder pain following a thoracotomy when compared to~     an epidural infusion of bupivacaine and fentanyl.~   "
120942|NCT01984450|"~     Study Title: A study to compare two articular cartilage repair techniques in the knee joint:~     Autologous Collagen Induced Chondrogenesis (ACIC) Vs. Mesenchymal Cell Induced Chondrogenesis~     (MCIC).~      Study hypothesis: We start with the hypothesis that both treatments are equally effective.~      Trial Design: This is a prospective study. The participating patients will be divided into~     two groups, each group receiving either one of the treatment modalities. This study will not~     be randomised or blinded. Both procedures will be done at the Spire Alexandra Hospital by~     Professor A. A Shetty, who is one half of the team that devised both techniques.~      Trial Participants: All participants will be from patients attending Professor Shetty's~     clinic at the Spire Alexandra Hospital.~      Planned Sample Size: 50 patients in each arm.~      Follow-up duration: The participating patients will be followed up at 2 weeks, 6 weeks, 3~     months, 6 months, 1 year and 2 years following the surgery by visits to the clinic and~     assessed clinically. The surgical outcomes will be measured by by IKDC, KOOS and Lysholm~     scores; cartilage growth will be measured by the MOCART score.~      Planned Trial Period: Two to three years~      Primary Objective: To establish superiority, if any, of either procedure over the other.~      Primary Endpoint: At the end of the 2 year follow up for all participating patients.~   "
120943|NCT01984437|"~     The purpose of the registry is to gather both retrospective and prospective case data on the~     use of the commercially available Magellan Robotic System and Magellan Robotic Catheters in~     accordance with the approved intended use. For prospective cases, follow-up patient data will~     be collected at 14 days (± 5 days) post procedure to assess treatment success, primary~     patency of intended targeted vessel region, and adverse events.~      The data will be analyzed for medical education, societal presentation, and/or publication by~     the investigators.~      Over the next 2+ years, physicians who meet the selection criteria will be invited to~     participate in the registry.~   "
120944|NCT01984424|"~     The primary objective of this study was to evaluate the effect of 24 weeks of evolocumab~     administered subcutaneously (SC) every month, compared with ezetimibe, on low-density~     lipoprotein cholesterol (LDL-C) levels in adults with high cholesterol who are unable to~     tolerate an effective dose of a statin due to muscle-related side effects (MRSE).~   "
120945|NCT01984411|"~     Cardiac catheterization is the most important test for the evaluation of cardiac patients.~     Since the beginning of the cardiac catheterization procedure, we have used the femoral artery~     puncture as a gateway for those procedures. Recently it is used more often the path for the~     radial. Using this approach has gained many followers worldwide and has been used almost~     routinely in our country but has not gained popularity because many interventional~     cardiologists argue that the transradial procedure is much more time-consuming and difficult.~      Research question: Are there differences in the total procedure time path between radial and~     femoral vascular to perform cardiac catheterizations?.~      This research focuses on the search for information to determine whether there are~     significant differences when the variables under study. This research is justified by the~     need to evaluate the two techniques in use and the lack of studies evaluating and comparing~     the radial arterial access in comparison with femoral access route which is widely used in~     all services hemodynamics national and international. The lack of research on the subject has~     made the use of the transradial procedure routinely not being done, because they have the~     idea that it is much more time-consuming and technically more difficult than the procedure~     performed by the femoral approach, hence Hemodynamics specialists, not everyone wants to~     start implementing the systematic use of the radial approach for cardiac catheterization~     studies.The main objective of this project is to determine the non-inferiority in terms of~     total procedure time path between radial and femoral vascular to perform cardiac~     catheterizations. Secondary objectives: the difference in time of puncture, duration of the~     procedure and recovery. Incidence of vascular complications and techniques between radial and~     femoral, presence of complications at 8 days of follow-up. Our aims to check through the~     results, if the difference in each of the variables favoring either of the two techniques and~     to determine the non-inferiority of one technique over the other in terms of ease and~     effectiveness of both procedures. The type of study is a controlled clinical trial open,~     randomized, non-inferiority. The study population will consist of patients who have been told~     the diagnostic cardiac catheterization, they are sent to the General Clinic Northern~     institution.~   "
120946|NCT01984398|"~     To determine and compare the pharmacokinetics (PK) of a single dose of each of two~     formulations of 12.5 mg and 25 mg Androxal administered to healthy male volunteers, and to~     determine and compare the safety of a single dose each of two formulations of 12.5 mg and 25~     mg Androxal administered to healthy male volunteers.~   "
120947|NCT01984385|"~     Hip VISION (Pilot Study) is a Prospective Observational Cohort Study to evaluate the~     incidence of overall and cause-specific mortality among consecutive patients aged ≥ 18 years~     presenting with hip fracture to the Juravinski Hospital of the Hamilton Health Sciences. This~     pilot study will assess the feasibility of a larger prospective international cohort study.~     After eligibility has been confirmed and informed consent has been obtained, participants~     will be registered in the study. Troponin level, complete blood counts and serum creatinine~     level will be collected at day 1 through day 10 post admission. CAM instrument will be~     employed at admission and once daily post admission day 1 through day 10. FIM Instrument will~     be administered within 72 hours of admission to establish pre-fracture functional~     independence and disability. Patients will be contacted by research personnel by telephone 30~     days after study registration.~   "
120948|NCT01984372|"~     This study is conducted in Asia. The aim of this post marketing surveillance (PMS) is to~     assess safety and effectiveness of long-term treatment with Tresiba® (insulin degludec) in~     patients with diabetes mellitus requiring insulin therapy under normal clinical practice~     conditions.~      A total of 4000 patients will be enrolled to investigate long term (3 years of treatment)~     safety of Tresiba® and additional 2000 patients will be enrolled to assess the safety in an~     early stage of the PMS more precisely. At the time of enrolment the patients will be randomly~     allocated to either 3 years or 6 months observation group.~   "
120949|NCT01984359|"~     To assess in an exploratory manner, the pronostic utility for locoregional control,~     progression-free and distant metastasis-free survival of a pre-therapy and post-therapy blood~     DNA test of HPV E6 and E7 DNA for subtypes 16 and 18 in p16+ and/or HPV+ oropharyngeal cancer~     patients. This will entail analysis of both initial pre-therapy HPV level as a continuous~     variable and initial post-therapy HPV level as a dichotomous variable.~   "
120950|NCT01984346|"~     This is a multi-center, open label, randomized pivotal study evaluating the safety and~     efficacy of the EPi-Sense-AF Guided Coagulation System for the treatment of persistent AF~     patients, refractory or intolerant to at least one Class I and/or III Anti Arrhythmic Drug~     (AAD).~   "
120951|NCT01984333|"~     Trichotillomania (TTM) remains one of the most poorly-understood and inadequately-treated~     conditions. Research has shown poor response inhibition (RI; the ability to inhibit~     inappropriate but potent response) as an important cognitive feature of TTM. Investigators~     have developed a computerized training program that aims to improve RI. Fifty children with~     TTM will be randomly assigned to (a) online 8-session RI training (n=25), or (b) 1-month~     waitlist condition (n = 25), and will be assessed at baseline, post-treatment, and 1-month~     follow-up. Investigators hypothesize that the online RIT will show greater improvement in TTM~     symptoms and RI capabilities at post-treatment and 1-month follow-up assessments, compared to~     the waitlist condition. This study will help develop an effective cognitive intervention~     program for TTM.~   "
120952|NCT01984320|"~     The effectiveness of cabergoline to prevent moderate-severe OHSS to coasting.~   "
120953|NCT01984307|"~     To characterize and estimate the size of different populations with a history of acute~     coronary syndrome in Sweden. To assess the burden of illness (co-morbidities, mortality rates~     healthcare resource utilization and atherothrombotic events) among patients with a history of~     myocardial infarction (MI) 1-3 years ago and additional risk factors for atherothrombosis.~   "
120954|NCT01984294|"~     This study will evaluate the antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose~     combination (FDC) plus ribavirin (RBV) or LDV/SOF plus GS-9669 in treatment-naive or~     treatment-experienced participants with chronic genotype 1 hepatitis C virus (HCV) infection.~     A total of 90 participants are planned to be enrolled in the study for 8 weeks of treatment,~     approximately 60 having had prior treatment with a regimen containing pegylated interferon~     (PEG) and RBV for ≥ 12 weeks. Randomization will be stratified by treatment-naive versus~     treatment-experienced and by HCV genotype (1a versus 1b).~   "
120955|NCT01984281|"~     The purpose of this study is to determine whether a pedometer-based unsupervised exercise~     program is more effective than a general exercise recommendation to increase lifestyle~     physical activity in adult patients with asthma.~   "
120956|NCT01984268|"~     Adenocorticotrophic Hormone provides safe and effective treatment to induce disease remission~     in rheumatoid arthritis patients with active disease due to an inadequate response to~     methotrexate.~   "
120957|NCT01984255|"~     This is a Open label, two-arm, randomized, two agent, single center trial.~   "
120958|NCT01984242|"~     This multicenter, randomized, open-label study will evaluate the efficacy, safety and~     tolerability of atezolizumab as monotherapy or in combination with bevacizumab versus~     sunitinib in participants with histologically confirmed, inoperable, locally advanced or~     metastatic renal cell carcinoma who have not received prior systemic therapy either in the~     adjuvant or metastatic setting.~   "
120959|NCT01984229|"~     This open-label study will investigate whether multiple oral doses of posaconazole affect the~     single dose pharmacokinetics of alectinib in healthy volunteers.~   "
120960|NCT01984216|"~     The purpose of this study is to compare the safety and superiority of Roux-Y versus Billroth~     II gastrojejunostomy reconstruction on delayed gastric emptying after pancreatoduodenectomy.~   "
120961|NCT01984203|"~     This study aims at determine if Progressive Heavy Load Exercises (PHLE) as treatment for~     patients diagnosed with Rotator Cuff Tendinopathy is superior to Standard Low-Load~     Exercises (LLE).~   "
120962|NCT01984190|"~     Venous thromboembolic events (VTE), either deep vein thromboses or pulmonary emboli, are~     important complications in patients undergoing knee or hip arthroplasty. This multicenter~     Clinical Registry is aimed at collecting large volume clinical effectiveness data of~     ActiveCare+S.F.T® mobile compression device +/- aspirin in lowering the potential risk of~     venous thromboembolism (VTE) prophylaxis in patients undergoing primary lower extremity total~     joint arthroplasty. The results can then be compared to pharmacology protocols.~   "
120963|NCT01984177|"~     This study will, in a sample of cocaine-dependent and healthy control subjects, administer~     corticorelin and compare dopamine release between groups. Dopamine release will be measured~     using PET neuroimaging with the radiotracer [11C]-(+)-PHNO.~   "
120964|NCT01984164|"~     The aim of this study is to conduct a 1-year double blind randomized control trial comparing~     candesartan to lisinopril in 140 individuals with hypertension and executive mild cognitive~     impairment in their effects on executive function, neuroimaging markers, and vascular~     indicators.~   "
120965|NCT01984138|"~     This study is investigating whether breast cancer patients who experience vaginal dryness~     while on anti-estrogen treatment could benefit from either vaginal estrogen or from a vaginal~     moisturizer called Replens.~   "
120966|NCT01984125|"~     Although most US adolescents visit their primary care doctor, their immunization rates are~     low. Primary care practices from two networks, one in upstate New York as well as a national~     network of pediatric clinics were surveyed to ask what they thought was the best strategy to~     increase immunization rates. Point-of-care prompts (either by an electronic health record~     message or by a nurse) when an adolescent patient comes in for any type of visit and is due~     for a vaccine was chosen. This study will determine if these prompts will increase~     immunization rates after a 12-month intervention period.~   "
120969|NCT01984086|"~     This is an open-label, two part, six period- cross over, randomised, single dose, single~     centre study in healthy subjects. This is the first clinical study for the UD-DPI. This study~     is divided into two parts. Part A will ascertain whether the pharmacokinetic (PK) of~     salbutamol delivered via the UD-DPI is comparable to the salbutamol delivered via the Diskus~     or MDI. For this reason four treatment doses consisting of three dose strength and two~     percentage blends will be assessed in Part A delivered via UD-DPI. Part A will also provide~     preliminary PK variability estimates to allow for better sample size/precision calculations~     for Part B. Part B will explore whether the UD-DPI has a pharmacokinetic exposure profile~     that is comparable to either Diskus or MDI in the presence of the charcoal block.~   "
120970|NCT01984073|"~     The purpose of this study is to understand whether a vitamin called NIcotinic ACid vitamIN~     (NIACIN for short, also known as vitamin B3) helps the body process dietary fat more~     efficiently. This is important because people with dyslipidemia have a problem with how they~     process fat, which raise the risk of heart disease.~   "
120971|NCT01984060|"~     The overall purpose of this research is to evaluate the effect of a home-based exercise~     program on physical function and to improve the health and quality of life for the~     HIV-infected older adult community.~   "
120972|NCT01984047|"~     The primary purpose of this study is to evaluate the safety, tolerability and~     pharmacokinetics of GSK3050002 in humans. Subjects will attend the clinical unit for a~     screening visit and if eligible and consenting, will attend to participate in the study~     within 30 days. Subjects will be admitted to the clinical unit the evening prior to dosing~     when each subject will receive a single intravenous dose of GSK3050002 or placebo, then~     remain in house under supervision until discharged on Day 3. Subjects will then return for 7~     outpatient visits scheduled over the following 81 days. Finally, the follow-up visit will be~     7-14 days following the last visit.~   "
120973|NCT01984034|"~     Background: The Portuguese National Health Directorate has issued clinical practice~     guidelines on prescription of anti-inflammatory drugs and COX-2 inhibitors, acid suppressive~     therapy and proton pump inhibitors, and anti-platelets. However, their effectiveness in~     changing actual practice is unknown. The objectives will be to compare the effectiveness of~     educational outreach visits in the implementation of clinical guidelines in primary care in~     Portugal against usual implementation strategies and to conduct a cost-effectiveness analysis~     of this method.~      Methods: The trial will be a parallel, cluster-randomized, unblinded, trial in primary care,~     with a 1:1 allocation ratio. This study will assess the effect of educational outreach visits~     on physician compliance with prescription guidelines. The general study hypothesis is whether~     educational outreach visits are superior to usual implementation of guidelines regarding the~     reduction of inappropriate prescribing (compliance with prescription guidelines). All~     National Health Service primary care units in the Lisbon (Portugal) region will be invited to~     participate. Units will be eligible if they are using an Electronic Health Record to issue~     prescriptions and have at least four doctors willing to participate. Doctors in intervention~     units will receive three educational outreach visits (one for each guideline) during a six~     months period, while the control group doctors will be offered an unrelated group training~     session (on using the international classification for primary care). Intervention visits~     will be one on one 15 minutes discussions conducted by guideline authors or trained family~     physicians at the physician's workplace. There are two primary outcomes, measured at the~     physician's level. One is the proportion of COX-2 inhibitors prescribed within the entire~     NSAID class, in defined daily doses 18 months after the intervention. The other is the~     proportion of omeprazole within the entire proton pump inhibitors class, in defined daily~     doses at 18 months post-intervention. Prescription data will be collected from the regional~     pharmacy claims database.~   "
120974|NCT01984021|"~     The aim of the proposed study is to evaluate the immediate effect of acupuncture on pain,~     cervical range of motion and electromyographic activity of the upper trapezius muscle in~     patients with nonspecific neck pain.Twelve patients with nonspecific neck pain and 12 healthy~     subjects will be enrolled in a randomized, single-blind, crossover study. Each patient will~     receive two forms of treatment in random order: a single session of traditional acupuncture~     and sham acupuncture. To eliminate carry-over treatment effects, a one-week wash-out period~     will be respected between sessions. Surface electromyography will be used to determine motor~     control in the upper trapezius muscle before and after treatment. The outcome measures in the~     group with neck pain will be a numerical pain rating scale (range: 0 [no pain] to 10 [maximum~     pain]), documentation of the pain area on a body chart and cervical range of motion. Linear~     regression analysis will be applied for each individual to investigate associations between~     the sEMG variables and force (excluding the sixth step). The slopes of the regression lines~     will be used to measure the sensitivity of the sEMG variables regarding changes in force. The~     Shapiro-Wilk test will be used to test the normality of the data distribution regarding RMS~     and MDF values in the third and sixth step of the step contraction. Paired samples (Student's~     t-test or Wilcoxon test) will be used to test differences between third and sixth contraction~     step. A mixed linear model will be used to analyze and compare the sEMG data during sustained~     contraction (five steps) between pre-acupuncture (EMG-1) and post-acupuncture (EMG-2)~     evaluations. These comparisons will demonstrate whether acupoints TE-5 and LI-11 affect the~     activity of the upper trapezius muscle, as hypothesized. The pain (NRS, PPT and area) and~     cervical ROM data collected during the four evaluations will also be compared using a mixed~     linear model. The Statistical Package for Social Sciences (SPSS, version 19.0 for Windows)~     will be employed for the statistical analysis, with the level of significance set to 5% (p <~     0.05).~   "
120975|NCT01984008|"~     The primary objective of this study is to demonstrate that investigation medication~     (Bowklean) is not less effective than the active comparator (Klean-Prep with Dulcolax), with~     regards to the overall quality of bowel preparation in subjects undergoing colonoscopy. An~     additional objective of this study is to collect subject's response to the acceptability and~     tolerability about bowel preparation and safety information.~      After bowel preparation, independent evaluator who is blinded to subject's treatment will~     evaluate the overall colon cleansing based on Aronchick and Ottawa scale. A total of 600~     eligible subjects scheduled to a colonoscopy will be randomly assigned with equal allocation~     to 1 of 2 treatment groups: Bowklean or Klean-Prep with Dulcolax. Each subject's~     participation is expected to be maximally 4 weeks in study duration (up to 3-week screening~     period followed by one week post colonoscopy).~   "
120976|NCT01983995|"~     Aromatase inhibitors are commonly prescribed for treatment of postmenopausal women with~     breast cancer. These medications can cause side effects in some women, and occasionally they~     can be quite bothersome. We are doing a study to better understand the side effects of~     aromatase inhibitors so that we can hopefully treat them better or possibly prevent them. In~     particular, we are interested in pain and difficulty sleeping. This study is designed to~     assess the effect of aromatase inhibitors on pain, sleep quality, and fatigue and the~     interplay of these side effects and their subsequent impact on daily activity. Each~     participant will fill out a series of questionnaires about pain, sleep quality, and fatigue~     and will also complete a sleep diary and wear an actigraphy watch for 10 days before starting~     an aromatase inhibitor and after taking it for 3 months. We hope to learn more about these~     symptoms so we can better manage medication toxicity in the future.~   "
120977|NCT01983982|"~     Many breast cancer survivors report chronic pain that develops or worsens following~     chemotherapy. The impact of chemotherapy on the development of chronic pain is uncertain. In~     this proposal, we are studying the impact of chemotherapy on a patient's sensitivity to pain.~     We are also investigating whether a patient's sensitivity to pain is related to how many~     symptoms she experiences during treatment.~   "
120979|NCT01983956|"~     It is assumed that an early palliative care structured by SENS (a systematic, problem-based~     assessment system) in addition to standard oncology care compared with standard oncology care~     alone relieves distress in patients with advanced cancer at the end of life.~      The primary objective of the trial is to determine the effectiveness of early palliative care~     intervention, structured by SENS (a systematic, problem-based assessment system) in addition~     to standard oncology care, compared with standard oncology care alone to relieve distress a)~     in patients with advanced cancer until death, and b) in caregivers. The secondary objectives~     are to determine whether the introduction of SENS improves quality of life, prolongs overall~     survival, ameliorates distress of caregivers, reduces health care costs and medical resource~     utilization (less aggressive treatment in the last weeks of life).~   "
120980|NCT01983943|"~     The purpose of this study is to conduct a double-blind, randomized controlled trial (RCT), to~     determine if six month supplementation of olive oil can improve the health of the blood~     vessels and improve long term health of the heart and blood vessels, in patients requiring~     percutaneous coronary intervention (PCI).~   "
120981|NCT01983930|"~     The purpose of this pilot study is to test whether 6 months of supervised weekly Kundalini~     yoga classes and a brief daily meditation homework assignment can improve memory and thinking~     in older adults with mild memory complaints when compared to weekly classes of memory~     training with daily homework assignments.~   "
120982|NCT01983917|"~     Prospective study to evaluate whether or not an internet application to coordinate and record~     diabetes management by the 1. diabetic patient/family caregiver 2. diabetic medical care team~     and 3. ophthalmology vision care team will decrease vision loss and blindness due to diabetic~     retinopathy. The aims will be measured through health psychology instruments to assess the~     effect of the application on management, motivation to control their disease, and commitment~     to comply with treatment. We will also measure objective health outcomes including Blood~     Pressure, Blood lipids level, hemoglobin A1c level, and Visual Acuity.~   "
120983|NCT01983904|"~     The purpose of this study is to examine the effects of sub-callosal cingulate (SCC) deep~     brain stimulation (DBS) in patients with treatment resistant depression (TRD).~      The working hypotheses are that long pulse-width DBS applied to the SCC region will lead to~     improvements in TRD patients, and specific neuroimaging biomarkers will correlate with~     response to DBS; the functional recovery will be enhanced with concurrent cognitive~     behavioural therapy (CBT).~   "
120984|NCT01983891|"~     This is a pilot intervention study conducted in four food shelves in the Twin Cities area.~     The aims of the study are to improve nutritional outcomes and client skills and self-efficacy~     among a culturally diverse group of food shelf clients through a nutrition education and meal~     preparation program. This study will also identify opportunities to expand the supply of~     healthy and culturally relevant foods in food shelves. The goal is to inform a larger-scale~     intervention to improve the nutritional quality and cultural relevance of food shelf items as~     well as client outcomes. The primary outcome is participant change in Health Eating Index~     scores from pre-intervention to post-intervetion.~   "
120985|NCT01983878|"~     The purpose of this study is to evaluate progression-free survival in participants with~     gastric or gastroesophageal junction cancer who have had disease progression following~     first-line therapy who undergo treatment with ramucirumab.~   "
120986|NCT01983865|"~     This clinical validation study is aimed at establishing a birch pollen challenge in the~     Fraunhofer ECC in patients allergic to birch pollen. The symptoms will be recorded on a~     validated symptom score as Total Nasal Symptom Score (TNSS), allowing to determine whether~     the challenge is dose dependent and reproducible.~   "
120987|NCT01983852|"~     Background Children living with life-limiting conditions have always been part of the health~     care system. Although there have been dramatic improvements in medical care, hundreds of~     children continue to die annually. The field of paediatric palliative care (PPC) and~     end-of-life (EOL) care is based on the principle that an interdisciplinary team should care~     for patients and their families. However, evidence on how to provide optimal PPC and EOL care~     covering the needs of children and their families is scarce and lags substantially behind~     that in the adult world. Few is known on how EOL care - defined as the last four weeks of~     life in this study - is presently provided in the Swiss health setting. The presented study~     Paediatric End-of-LIfe CAre Needs in Switzerland [PELICAN]) covers paediatric EOL care and~     will contribute to a comprehensive understanding of EOL care in Switzerland by analysing~     retrospectively medical charts of children/young people between 0 - 18 years who died in the~     years 2010 and 2011 in Switzerland. A survey instrument will be developed and pilot tested to~     assess the perspectives of families who have experienced the loss of a child. After the~     development pilot testing and adaptation of the instrument a survey with parents who lost a~     child in the years 2010 and 2011 will take place. Furthermore, the experiences and needs of~     health professionals working in the field of pediatric EOL will be explored.~   "
120988|NCT01983839|"~     At the Department of Infectious Diseases, Aarhus Denmark, moxifloxacin is used in the~     empirical treatment of severe community-acquired pneumonia (CAP). This study was designed to~     determine the pharmacokinetics of moxifloxacin 400 mg/day to patients treated empirically for~     CAP. To accomplish this aim, we established a pharmacokinetic population model. This approach~     was adopted with the dual purpose of assessing the potential efficacy of the drug and~     performing Monte-Carlo simulations to characterize the maximal MICs for which recommended~     pharmacokinetic-pharmacodynamic (PK-PD) targets are obtained for pathogens commonly known to~     cause CAP.~   "
120989|NCT01983826|"~     The overarching question addressed in the current project is: Does dietary nitrate~     supplementation (8 weeks) improve physiological function in patients with peripheral arterial~     disease (PAD)? The investigators will specifically address whether dietary nitrate~     supplementation enhances blood vessel function, blood pressure regulation, and exercise~     capacity. The proposed project uses an array of clearly defined measurements which will allow~     investigators to quantify blood vessel function (vasodilator responsiveness and arterial~     stiffness), blood pressure (variability and responsiveness to stress), and functional~     capacity before and after 8 weeks of dietary supplementation.~   "
121153|NCT01981681|"~     PF-06263276 is a first in class inhibitor of the Janus kinase (JAK) enzymes 1, 2, 3 and~     tyrosine kinase 2 (TYK2) that is being developed for the treatment of chronic plaque~     psoriasis. The goal of the study is to assess the safety, local tolerability, and~     pharmacokinetics in healthy subjects.~   "
120991|NCT01983800|"~     Heavy sedation or sleep is a common problem within the intensive care unit (ICU) using our~     standard intravenous medications. This commonly leads to confusion, low blood pressure, slow~     wake up and removal of the artificial breathing tube (extubation), which prolongs ICU stay.~     Using inhaled volatile anesthetic agents are likely to improve these patient outcomes. This~     unique project is the first North American study looking at using volatiles for patients who~     need longer-term ICU sedation. This project has excellent potential at lowering these~     complications and improving quality of care, which will lower patient ICU stay and healthcare~     costs.~   "
120992|NCT01983787|"~     At the Department of Infectious Diseases, Aarhus University Hospital, continuous infusion~     with piperacillin/tazobactam for a period of 2 weeks, has been used for several years in~     patients with cystic fibrosis, suffering from acute pulmonary exacerbations (APE).~      It is an outpatient treatment. To assess the efficacy and quality of the treatment, a blood~     test every 3rd day is taken to determine the concentration of Piperacillin in blood-plasma.~   "
120993|NCT01983774|"~     Gastroesophageal reflux disease is a common problem in cystic fibrosis (CF). It may lead to~     worsening lung function and more respiratory infections for a person with CF. This study will~     look at treating GERD with a medication, esopmeprazole. The medication stops stomach acid~     from being made. The study will see if there are fewer respiratory infections and improved~     lung function in patients with CF when taking esomeprazole.~   "
120994|NCT01983761|"~     The goal of this clinical research study is to learn if it is safe and feasible to transplant~     patients with one of two units of cord blood that has been changed in the laboratory before~     it is given. Only patients with leukemia, lymphoma or myelodysplastic syndrome will be~     allowed on this study. The secondary goal is to obtain the preliminary efficacy outcome.~     Researchers also want to learn if using cord blood that has been changed can help to control~     the disease.~      One cord blood unit will not be changed before it is administered to you. The cord blood unit~     that will be altered will be changed to use sugar that is found in small amounts in blood~     cells. It plays a role in telling transplanted cells where they should go in the body. Adding~     more sugars to the cord blood cells in the laboratory helps the cord blood cells find their~     way to the bone marrow faster. This process is called fucosylation.~      Conditioning is the chemo and other medicines and will be given to patients to prepare to~     receive cord blood transplant cells. This prevents immune system from rejecting the cells.~     Conditioning will be started before the transplant.~      ATG is a protein that removes immune cells that cause damage to the body.~      Clofarabine is designed to interfere with the growth and development of cancer cells.~      Fludarabine is designed to interfere with the DNA of cancer cells, which may cause the cancer~     cells to die. This chemotherapy is also designed to block your body's ability to reject the~     donor's bone marrow cells.~      Melphalan and busulfan are designed to bind to the DNA of cells, which may cause cancer cells~     to die.~      MMF and tacrolimus are designed to block the donor cells from growing and spreading in a way~     that could cause graft versus host disease (GVHD -- a condition in which transplanted tissue~     attacks the recipient's body). This may help to prevent GVHD.~      Rituximab is designed to attach to cancer cells, which may cause them to die.~      A Phase I study for treatment of patients (N=25) with hematologic malignancies and MDS who~     are candidates for dual-cord UCBT is ongoing at M.D. Anderson Cancer Center under an~     Investigator-initiated IND Application, E.J. Shpall, MD, PI. Since August, 2012, Preliminary~     results indicate that ASC-101 UCBT is well-tolerated and no ASC-101 related untoward adverse~     events have been observed. To date, the median time to neutrophil engraftment (N=9) is 15~     days, and the median time to platelet engraftment (N=9) is 33 days. The trial remains~     ongoing.~   "
120995|NCT01983748|"~     Patients suffering from uveal melanoma (typed positive for monosomy 3 and without evidence~     for metastases) will be vaccinated over a period of 2 years with Dendritic Cell loaded with~     autologous Tumor RNA.~      200 patients will be included. The Trial is an open multicenter Phase III Trial.~   "
120996|NCT01983735|"~     The aim of present study is to evaluate the efficacy and safety of two dose combination of~     Telmisartan/S-Amlodipine (80/2.5mg and 80/5mg) compared with S-Amlodipine monotherapy (2.5mg~     and 5mg) in patients with Stage 2 hypertension.~   "
120997|NCT01983722|"~     Expanded access to Stiripentol for patients with Dravet Syndrome.~   "
120998|NCT01983709|"~     The objective of this study is to determine if systemically infused allogeneic bone marrow~     derived mesenchymal stem cells (MSC) home to sites of prostate cancer in men with localized~     adenocarcinoma of the prostate that are planning to undergo a prostatectomy. Investigators~     plan to systemically infuse MSCs 4, 6 or 8 days prior to enrolled subjects' planned~     prostatectomies. Investigators will then quantify the relative amount of donor MSC DNA to~     recipient DNA present in patients' explanted prostate specimens. This will be accomplished~     via BEAMing digital PCR. This trial will provide the foundation for future studies aimed at~     engineering MSCs to deliver a toxin to sites of metastatic prostate cancer.~   "
120999|NCT01983696|"~     To investigate the effect of low oxygen tension during in vitro culture in terms of embryo~     quality and outcomes of pregnancy in vitro fertilization/ Intracytoplasmic sperm injection~   "
121000|NCT01983683|"~     This clinical study is conducted to assess the efficacy of cadazolid compared to vancomycin~     in subjects with Clostridium difficile-associated diarrhea (CDAD).~   "
121001|NCT01983670|"~     In individuals with spino-cerebellar atrophy (SCA), the delayed onset of antagonist muscle~     firing has been reported to be the cause of hypermetria. Hypermetria is a common deficit in~     individuals with spino-cerebellar atrophy SCA when they perform ballistic goal-directed~     movement. Based on the previous studies, ballistic goal-directed movements are controlled by~     a triphasic pattern of agonistic and antagonistic muscle activation. The origin of the EMG~     pattern is a central program, whereas the delayed onset of antagonistic muscle firing has~     been reported to be the cause of hypermetria. To develop a therapy method, the difference in~     temporal pattern and intensity of supraspinal excitability of agonist and antagonist bursts~     between healthy adults and individuals with SCA when performing rapid and slow goal-directed~     movements should be further investigated.~      Traditional rehabilitations of individuals with cerebellum lesion were limited to improve the~     functional performance of movement. Since the deficits of the goal-directed movement are at~     pre-movement programming, only feedforward training will be possible to re-establish an~     appropriate program.~      Previous showed that peripheral stimulation resulted in a facilitation of motor cortex. Our~     group also found that this facilitation in individuals with SCA was similar to the ones~     without SCA. Therefore, it is possible to adjust the control pattern of supraspinal~     excitability of agonist and antagonist busts of SCA patient with passively providing~     electrical stimulation contains normal control pattern of healthy human.~      The present study sought to investigate the difference in temporal pattern and intensity of~     supraspinal excitability of agonist and antagonist bursts between healthy adults and~     individuals with SCA when performing rapid and slow goal-directed movements.~   "
121002|NCT01983657|"~     The purpose of this study is to establish an efficient and economic treatment scheme by~     evaluation of the safety and efficacy of subcutaneous injection of low-dose rhGM-CSF, or of~     similar injection after whole lung lavage , in patients with PAP.~   "
121004|NCT01983631|"~     The Cerebellum contains ten percent of the total volume of the brain and receives brain,~     spinal cord and vestibular sensory input. The organization of vestibular and somato-sensory~     afferent informations are also reported to be impaired in patients with cerebellum~     dysfunctions. Ataxia and impaired balance control are common symptoms in individuals with~     spinocerebellar ataxia (SCA). Previous studies have shown that patient with cerebellar damage~     are usually agonist and antagonist muscle coordination problem. Past studies also found the~     regulation of reciprocal Ia inhibition was impaired in patients with spinaocerebellar ataxia.~     In chronic phase, weakness might be developed due to deconditioned. All deficits mentioned~     above might lead to a decrease functional ability. Therefore, increasing somato-sensory and~     vestibular input, normalizing the modulation of recriprocal inhibition, and improve muscle~     strength might be able to improve the functional abilities of individuals with SCA.~      Recently, whole body vibration (WBV) has been trained for health groups. Studies showed that~     WBV training were able to improve muscle strength, balance control, and functional ability.~     However, there is no evidence showed that whether the whole body vibration training can~     affect the brain and spinal cord for the regulation of neural circuits. Whether also can~     affect for maximal voluntary contraction and improve central fatigue. No previous studies~     that whole body vibration training for SCA.~      Therefore, the purpose of this research was to investigate the intracortical facilitation and~     inhibition, reciprocal Ia inhibition, low frequency depression, maximal voluntary~     contraction, interpolated twitch technique to compare the different between the SCA and~     health subject. Also to investigate the short term and long term effect of WBV.~   "
121005|NCT01983618|"~     Beachchair position is used by many orthopaedic surgeons for shoulder surgery. Most patients~     undergoing surgery in this position have no complications. However, reported cases of~     postoperative neurological deficits have highlighted the risk of cerebral and spinal cord~     ischemia. The etiology of such complications remains unclear. The most plausible explanation~     for these events would be intraoperative hypotension followed by cerebral hypoperfusion.~      General anesthesia is commonly used for shoulder surgery in conjunction with interscalene~     brachial plexus blockade. During the block, local anesthetic's spread is frequently observed~     leading to a block of sympathetic fibres. Since all nerves located in the head and neck area~     go through the stellate ganglion, its block will cause a sympathetic denervation and a~     decrease of the peripheral vascular resistance, thus increasing the circulation in cerebral~     blood vessels. In normal situations, there is a vasoconstriction of the cerebral blood~     vessels in response to a sympathetic stimulation and a vasodilation if sympathetic fibres are~     blocked.~      Transcranial Doppler (TCD) is a non-invasive examination that provides a reliable evaluation~     of intracranial blood flow in real-time. It can help to detect sudden changes in perfusion~     and identify potential embolic events. Some studies using TCD have shown an increased~     ipsilateral cerebral blood flow (CBF) secondary to a reduced vascular tone associated with a~     stellate ganglion block. Others have shown a reduction of contralateral CBF that could~     theoretically increase the risk of ischemia in the affected area.~      This study will assess the role of interscalene nerve blockade in the protection of cerebral~     ischemia and preservation of cerebral autoregulation. This study will also aim to identify~     changes in contralateral CBF.~      The investigators hypothesize that:~        1. Interscalene nerve block will increase CBF~        2. Interscalene nerve block will not decrease contralateral CBF~        3. Cerebral autoregulation will be preserved under general anesthesia in conjunction with~          an interscalene nerve block in this setting.~   "
121006|NCT01983605|"~     Evaluate the safety and effectiveness of the LARIAT Suture Delivery device in excluding the~     left atrial appendage in 100 patients.~   "
121007|NCT01983592|"~     Fatigue is frequently identified as one of the most troublesome symptoms in cancer patients~     and there are very few conventional therapies which can address the symptom of fatigue in~     patients who are undergoing cancer treatment.~      This study will be testing whether the administration of a complementary therapy~     (individualized homeopathy) to a patient undergoing chemotherapy treatment is feasible and~     whether this treatment can lessen the fatigue symptoms of adults. The study will also test~     whether the n-of-1 study design is feasible in this population.~   "
121008|NCT01983579|"~     This is a prospective, open label study assessing the 24-hour IOP patterns using TF in~     patients undergoing anti-VEGF injection for the treatment of neovascular AMD (age related~     macular degeneration). The study will be proposed to patients with AMD and patients with AMD~     and concomitant open angle glaucoma (OAG).~      The study will be conducted in two stages. In both stages, patients will remain ambulatory~     and will be encouraged to follow a schedule as close to their usual lifestyle as possible,~     with the exception of particular activities such as caffeine intake, playing wind~     instruments, yoga and strenuous exercise. A patient diary will be distributed for the capture~     of patient activities during the TF pattern recording. Upon completion of each session, the~     CLS (contact lens sensor) will be removed and a final ophthalmic examination will be~     conducted.~      In the first stage of the study, 20 patients with neovascular AMD with an IOP in the normal~     range and no concomitant glaucoma will be recruited. After having signed and dated the~     patient informed consent form, patients will undergo an initial ophthalmic examination. One~     eye will be selected for the study. If both eyes are eligible, the study eye will be selected~     in random manner.~      All 20 AMD patients will receive two 24-hour recording sessions (S) with the TF CLS, at~     monthly interval. In the first session (S1) anti-VEGF injection will be carried out according~     to the study center standard protocol. For the second 24-hour TF recording session (S2),~     patients will be randomly distributed into three groups. Group A, consisting of 5 patients,~     will receive anti-VEGF injection with a different anti-VEGF substance as compared to S1.~     Group B, also consisting of 5 patients, will receive anti-VEGF without sclerotomy occlusion~     after injection as compared to S1. Finally, group C, including 10 patients, will receive~     anti-VEGF in a different dose (injection volume) as compared to S1. The randomization ratio~     between groups A, B and C is 1:1:2.~      The overall study duration for an eligible patient in the first stage of this study is~     limited to 5 weeks.~      If in the first stage of this study an injection protocol is identified that provokes~     significantly lesser elevation on the TF pattern, the alternative injection protocol will be~     evaluated against the current standard protocol. For the second stage, 30 patients of whom 15~     with neovascular AMD and 15 with neovascular AMD and concomitant OAG will be recruited. After~     giving informed consent and confirmation of eligibility, all patients will receive two~     24-hour TF CLS recording sessions (S3 and S4) at monthly interval, during which anti-VEGF~     injection according to the standard and alternative protocol will be carried out in random~     sequence.~      The overall study duration for a patient in the second stage of the study is limited to 5~     weeks.~      The study has been planned to recruit 20 eligible patients in the first stage within 12 weeks~     from the date of initiation. The second stage will recruit 30 patients within 16 weeks. Hence~     the overall study duration from the first patient accrued into the study until last patient~     out equates to about 33 weeks. Allowing for a database lock within 4 weeks of study~     completion, a preliminary statistical report on the primary efficacy endpoint is foreseen~     within 2 weeks thereafter.~   "
121009|NCT01983566|"~     The purpose of this trial is to investigate the effect of food with different fat content and~     of gastric pH increase (mediated by multiple dosing of omeprazole) on the relative~     bioavailability of deleobuvir.~   "
121010|NCT01983553|"~     The purpose of this study is to conduct a passive surveillance of hospitalized dengue cases~     in subjects who participated in study CYD23 (NCT00842530).~      The Objectives are:~        -  To describe the incidence of virologically-confirmed hospitalized dengue cases.~        -  To characterize hospitalized dengue cases.~        -  To evaluate the occurrence of related and fatal serious adverse events (SAEs).~   "
121011|NCT01983540|"~     This is a follow-up of the primary series vaccination schedule in Study A3L24 (NCT01177722)~     and booster vaccination in Study A3L27 (NCT01444781).~      Study Objective:~        -  To describe the long-term antibody persistence at 3.5 and 4.5 years of age following a~          3-dose primary series vaccination of either DTaP-IPV-Hep B-PRP-T+Prevenar™ (PCV7)~          +Rotarix™ or Infanrix hexa™+Prevenar™ (PCV7) +Rotarix™ vaccination at 2, 4, 6 months of~          age and a booster vaccination of DTaP-IPV-Hep B-PRP-T+Prevenar™ (PCV7) or Infanrix~          hexa™+Prevenar™ (PCV7) at 12 to 24 months of age.~      Observational Objectives:~        -  To describe the long-term antibody persistence by group and by stratification on the age~          at inclusion of the A3L27 booster study.~        -  To describe the effect of one additional oral dose of stand alone poliovirus isotypes 1,~          2 and 3 vaccine* on the antibody persistence immune response for poliovirus isotypes (4~          vs 5 doses of poliovirus administered).~   "
121012|NCT01983527|"~     Arthrographic distention of the shoulder joint is an increasingly popular treatment option in~     the management of patients with frozen shoulder. Most have included the intra-articular~     injection of a corticosteroid as part of the procedure, but it is not known if this is~     necessary. It is also not known whether arthrographic distention using steroid and saline is~     better than intra-articular steroid injection alone.~      The purpose of this study is to determine whether there is an additional benefit in the~     combination of arthrographic distention plus intra-articular corticosteroid injection~     compared to arthrographic distention or intra-articular corticosteroid injection alone.~   "
121013|NCT01983514|"~     Oxytocin (OT) is a small, naturally occurring peptide currently in clinical use to stimulate~     lactation in breastfeeding women. The intranasal administration of OT has recently attracted~     attention as a potential novel treatment in several psychiatric disorders including autism.~     However, given the anatomy of the nasal cavity, the current design of nasal sprays would be~     expected to provide an inadequate delivery of medication to the areas of the nasal cavity~     where direct transport into the brain via the olfactory nerve could potentially occur.~     OptiNose has developed an intranasal delivery device that provides improved reproducibility~     of nasal delivery, improved deposition to the upper posterior regions of the nasal cavity~     where the olfactory nerve innervates the nasal cavity.~      The primary objective of this study is to identify any differences between single dose 8 or~     24 international units (IU) oxytocin delivered intranasally with the optimised OptiNose~     device and 1 IU oxytocin administered as slow intravenous infusion in healthy volunteers.~     This will be measured in terms of brain activity as measured with functional magnetic~     resonance imaging (fMRI), performance on cognitive tests, and physiological markers.~   "
121014|NCT01983501|"~     The purpose of this study is to determine the maximal tolerated dose (MTD) or recommended~     dose (RD) and to assess the safety and tolerability of tucatinib (ONT-380) combined with~     ado-trastuzumab emtansine (T-DM1) in patients with HER2+ breast cancer.~   "
121015|NCT01983488|"~     This study is aimed at investigating the long term clinical outcome of patients with uveitis.~   "
121016|NCT01983475|"~     Sublesional bone loss after acute spinal cord injury (SCI) is sudden, progressive, and~     dramatic. After depletion of bone mass and the loss of architectural integrity, it may be~     difficult, if even possible, to restore skeletal mass and strength. Denosumab is a relative~     new, highly potent anti-resorptive agent that has proven efficacy in postmenopausal~     osteoporosis to improve bone mass and in solid tumor patients to prevent a skeletal-related~     event to a greater extent than that with bisphosphonate administration. In persons with~     complete motor lesions, bisphosphonates have not been effective at reducing bone loss at the~     knee, the site of greatest relevance because of its increased risk of fracture. Anti-RANKL~     therapy appears to be more potent than bisphosphonates in animal models of bone loss due to~     immobilization, suggesting that treatment with denosumab may prove to be an efficacious~     therapy for persons with acute SCI to preserve bone mass and strength.~   "
121017|NCT01983462|"~     The purpose of the study is to test the effects of: 1) blocking sympathetic nerve activity~     with a drug called clonidine, and 2) by blocking a kidney protein called renin, and on blood~     vessel function and muscle nerve activity in adults who are obese and have high blood~     pressure.~      Years 1 and 2: The 1st cohort of subjects will consist of 69 healthy young men and women age~     18-79 years who are obese, defined as a body mass index > or = to 30 kg/m2, who have~     untreated systolic hypertension (systolic blood pressure > or = to 130 - <180 mmHg- average~     of at least 3 measurements 2 min apart after 10 min seated resting position). These 69~     subjects will then be randomized to 3 treatment arms: clonidine (0.1 mg/day),~     hydrochlorothiazide (25 mg/day) or placebo for 4 weeks in years 1 and 2. All tablets will be~     encapsulated by to look identical. Subjects will randomly (1:1:1) receive one of the~     following combinations in a double-blind, placebo-controlled design:~        1. Oral clonidine (0.1 mg twice/day)~        2. Oral hydrochlorothiazide (12.5 mg twice/day)~        3. Oral placebo~      In addition to 69 healthy young men and women, we will also enroll 15 obese adults with~     'normal/optimal' systolic blood pressure (<120mmHg) who will undergo baseline testing only~     (Visits 1, 2 and 3).~      Years 3 and 4: A 2nd cohort of subjects (n=42) will be randomized to aliskiren (150 mg/day),~     hydrochlorothiazide (25 mg/day) or placebo for 4 weeks. All tablets will be encapsulated to~     look identical. Subjects will receive one of the following in a randomized, double-blind,~     placebo-controlled design:~        1. Oral Aliskiren(150 mg/day- once per day)~        2. Oral Hydrochlorothiazide (12.5 mg twice/day)~        3. Oral placebo~   "
121018|NCT01983449|"~     To assess the safety and effectiveness of adventitial deposition of the Study Drug in~     reducing inflammation and restenosis in patients with clinical evidence of claudication or~     critical limb ischemia and an angiographically significant lesion in the superficial femoral~     and/or popliteal arteries.~      Study Drug and Dose: Dexamethasone Sodium Phosphate Injection, USP, 4 mg/ml, with dilute~     contrast (17%) administered to the adventitia in a dose of 1.6 mg per cm of desired vessel~     treatment length.~   "
121019|NCT01983436|"~     Orthognathic surgery aims to standardize position of the maxilla and the mandible and~     therefore chewing, breathing, phonation and swallowing functions. In postoperative, several~     physical and functional consequences are observed in patients: transient edema of the face,~     maxillo-mandibular blocking (causing difficulties to eat and occasional weight loss), pain~     and sensory disturbances (labial or/and chin paresthesias).~      Achieving sessions of manual lymphatic drainage by physiotherapist may allow faster decrease~     of postoperative edema, improved postoperative comfort and mental well-being.~      The main objective of this study is to evaluate the efficacy of sessions of manual lymphatic~     drainage to reduce postoperative edema.~   "
121020|NCT01983423|"~     Animal and clinical studies have suggested that local tissue trauma can promote the process~     of an embryo implanting in the uterine cavity. The clinical studies have been performed in~     patients with a history of previously failed treatments using in vitro fertilization; a~     process of stimulating many eggs from a women and removing them from the body, to allow~     fertilisation with sperm to occur in a laboratory setting. The embryos are then replaced into~     the uterine cavity.~      This study questions whether endometrial biopsy (placing a small straw like catheter through~     the cervix and into the uterine cavity to take a sample of tissue via suction into the bore~     of the catheter), within 5-10 days of starting a cycle of in vitro fertilization, will~     improve pregnancy outcome for patients in the first or second cycle of treatment. The~     hypothesis is that endometrial biopsy will improve pregnancy outcome.~      The study is a randomized multicentre study involving 3 Canadian fertility centres.~   "
121023|NCT01983384|"~     There is recent, but limited evidence to suggest that anesthetic depth is associated with~     poor postoperative cognitive outcomes. Specifically, several studies suggest that deeper~     level of anesthesia is associated with increased incidence of postoperative delirium and~     longer-term cognitive decline. In fact, some suggest that older patients undergoing surgery~     should routinely be monitored with an anesthetic depth monitor to allow the titration of~     anesthetics or sedation medications to lighter levels to promote better postoperative~     cognitive outcomes. However, such a practice has never been validated or proven to be~     feasible or safe. Accordingly, the investigators plan an exploratory study to determine the~     feasibility and safety of randomizing patients undergoing major surgery to receive deep vs.~     light anesthetic levels during surgery.~   "
121024|NCT01983371|"~     The purpose of this study is to determine the diagnostic accuracy of ferumoxytol-enhanced MRI~     in detecting lymph nodes that have been invaded by tumor cells in patients with colorectal~     cancer.~   "
121025|NCT01983358|"~     The purpose of this study in to evaluate safety, tolerability, pharmacokinetics of JPI-289 in~     healthy male subjects.~   "
121026|NCT01983345|"~     The open surgical repair of myelomeningoceles before 26 weeks gestational age provides a~     correction of the anomaly of Chiarri, reduces the incidence of ventriculomegaly (defined as a~     measure of the ventricles at the crossroads ≥ 10 mm), and get a lower of injury than one~     corresponding to the anatomical defect (as defined by the last upper normal vertebra before~     the defect).~      The purpose of this study is to introduce in France an innovative technique for prenatal~     repair of myelomeningocele until now developed only on the American continent.~   "
121027|NCT01983332|"~     The purpose of this study is to examine the impact of an introduction to the occupation-based~     theory (MOHO) on the clinical reasoning of therapists working with cancer clients.~   "
121028|NCT01983319|"~     The aim of this study is to determine whether noninvasive brain stimulation in form of active~     transcranial direct current stimulation (tDCS) combined with constraint induced movement~     therapy (CIMT) offers an additional benefit as compared with sham tDCS combined with CIMT in~     patients with stroke. Furthermore the purpose is to highlight changes in GABA activity more~     than 3 months after stroke and its importance for effect of tDCS and CIMT combined with tDCS.~   "
121029|NCT01983306|"~     The purpose of this study is to evaluate the safety and efficacy of a range of oral SP-333~     doses for the treatment of opioid-induced constipation (OIC) in adults with non-cancer pain~     taking opioids.~   "
121030|NCT01983293|"~     The purpose of this study is to analyze the effect of left ventricular (LV) lead pacing~     location in the non-left bundle branch block (NLBBB)heart failure (HF) patient population.~     The LV lead pacing location will be guided by either the pacing site with the largest amount~     of dyssynchrony as measured by the LV electrical delay (QLV) or the physician's standard of~     care implant approach.~   "
121031|NCT01983280|"~     Adequate sleep is an important aspect of any healing process, and because it is known that~     children recovering from burns suffer long term sleep disruptions, the investigators believe~     that Healing Touch may improve the quality and quantity of sleep in the pediatric burn~     population.~   "
121032|NCT01983267|"~     Cannabis sativa is one of the most ancient psychotropic drugs known to humanity. Although~     most Western countries have outlawed the use of cannabis according to the UN Convention of~     Psychotropic Substances, an increasing number of states in the USA, Canada and several~     European countries allow the medicinal use of cannabis subject to a doctor's recommendation.~     In oncology, the beneficial effects of treatment with the plant or treatment with medicine~     produced from its components are related to symptoms of the disease: pain, nausea and~     vomiting, loss of appetite and weight loss. There is only partial clinical evidence of the~     efficacy of cannabis for these indications. In Israel, according to Ministry of Health~     regulations, permission to use medicinal cannabis for oncology patients can be given for two~     indications: to relieve disease-related symptoms in advanced disease or during chemotherapy~     treatment to reduce side effects. The indications are very wide and allow a great deal of~     freedom for the physician's decisions, but also cause high demands for cannabis from~     patients.~      The cannabis plant and the synthetic drugs based on the plant are considered to be medically~     safe. Most of the adverse effects are related to the fact that the plant and the drugs are~     psychoactive. Among the effects named were dizziness, euphoria, difficulty concentrating,~     disturbances in thinking, memory loss, and loss of coordination.~      Recently, we published the results of a prospective, observational study evaluating the~     medical necessity for medicinal cannabis treatment in cancer patients on supportive or~     palliative care. No significant side effects, except for memory lessening in patients with~     prolonged cannabis use (p=0.002), were noted.~      Chemotherapy-related cognitive impairment (CRCI) is a phenomenon of cognitive decline that~     patients may experience during or after chemotherapy. Memory loss and lack of concentration~     and attention are the most frequent symptoms encountered. Evidence suggests that CRCI is of~     significant concern to patients and has become a major quality-of-life issue for survivors,~     with estimates of its frequency ranging from 14-85% of patients. The influence of cannabis~     use on cognitive functions of oncology patients has never been tested. Theoretically, the~     combination of chemotherapy and cannabis can cause severe reduction in cognitive functions in~     additive or synergistic ways. However, this hypothesis, too, has never been tested, although~     the number of patients using cannabis during chemotherapy treatments in Israel and in other~     Western countries is growing.~      Goals of current research: The main goal of the study is to evaluate prospectively the level~     of reduction in cognitive function of cancer patients who are on active oncology treatments~     and use cannabis, comparing to a group of patients without cannabis treatment. The second~     goal is to identify high-risk groups for cognitive impairment due to cannabis use.~      Patients and Methods: The study will be comprised of a cannabis user group that will include~     patients who will come for guidance sessions before being issued with a cannabis license and~     a control group of patients on active oncology treatments, meeting the same inclusion and~     exclusion criteria (except for cannabis use), and willing to complete the same pack of~     questionnaires and cognitive tests at the same three time points. All patients will sign an~     informed consent form. The study includes questionnaires on quality of life (EORTC-Q30),~     anxiety, depression (HADS) and fatigue (BFI), and cognitive tests (MoCA, DSST, Digital Finger~     Tapping) administered by the nurses who give guidance on cannabis according to the patient's~     language (Hebrew, Russian or Arabic). The nurses will have a short guidance course on how to~     do cognitive tests and a monthly meeting with a neuropsychologist to test the quality of the~     cognitive tests. The questionnaires and cognitive tests will be done on the day of entering~     the study (T0) and after 3 (T3) and 6 months (T6). The patients will be asked not to use~     cannabis in the 12 hours before the interviews after 3 and 6 months.~      Sample size: The sample size was built to show a difference of 1.1 points in the MoCA test~     (half the SD for the normal population) between two groups after three months of cannabis~     use. The number of patients needed with a power of 80%, β≤0.05 and SD=3.1 (the SD for mild~     cognitive impairment in the MoCA test) is calculated at 42 patients in each group (total 84~     patients). Due to an expected drop-out of 20%, the number of patients to be included in the~     study is 101.~   "
121033|NCT01983254|"~     Patients who receive life support in intensive care units commonly suffer from persistent~     depression, anxiety, and post-traumatic stress disorder (PTSD) symptoms after discharge. We~     are trying to learn which is a better way to manage this distress: a telephone-based adaptive~     coping skills training program or an educational program.~   "
121034|NCT01983241|"~     This is a multi-center, randomized, placebo-controlled, double blind clinical study to assess~     the efficacy and safety of two separate dose regimens of Alpha-1 MP versus placebo for 156~     weeks (i.e., 3 years) using computed tomography (CT) of the lungs as the main measure of~     efficacy. The two Alpha-1 MP doses to be tested are 60 mg/kg and 120 mg/kg administered~     weekly by IV infusion for 156 weeks. The study consists of a Screening Phase, a 156-week~     Treatment Phase, and an End of Study Visit at Week 160.~   "
121035|NCT01983228|"~     The long term goal is to improve the quality and equity of chronic pain treatment among VA~     patients. The primary objective of this study is to improve pain outcomes among black VA~     patients with chronic, musculoskeletal (MSK) pain, who experience poorer pain treatment and~     outcomes than their white counterparts. The work proposed is expected to result in a~     non-pharmacological intervention, delivered by telephone, designed to reduce pain and improve~     functioning among black patients with MSK pain, by promoting walking. This intervention is~     specifically designed to address factors that contribute to MSK pain among black Veterans;~     however, the investigators expect that it will also benefit non-black Veterans. The proposed~     research is innovative, in its use of proactive outreach and recent advances in~     self-regulation strategies (such as Action Planning) to help black Veterans overcome~     psychological, environmental, utilization-related, and provider-related barriers that~     contribute to pain.~   "
121036|NCT01983215|"~     The purpose of the study is to determine the effects of Prevena therapy on decreasing groin~     surgical site infections in patients who are obese and /or diabetic having vascular surgery.~   "
121037|NCT01983202|"~     The aim of the study is to investigate body composition in newborn children of women with~     PCOS and controls and to investigate adverse obstetric outcomes in pregnant women with PCOS.~   "
121038|NCT01983189|"~     This study is a trial of low frequency Repetitive Transcranial magnetic stimulation( rTMS)~     for subjects with autism spectrum disorders, specially targeting repetitive behaviors.~   "
121039|NCT01983176|"~     The aim of this study was to determine the histopathological results of parotid tumors and~     postoperative complications after partial superficial or total parotidectomy with facial~     nerve dissection and superficial musculoaponeurotic system reconstruction.~   "
121040|NCT01983163|"~     In children aged 1yr -18 years with refractory epilepsy Modified Atkins diet as add on to~     ongoing AED therapy would not be inferior compared to ketogenic diet ** in terms of seizure~     reduction from baseline seizure frequency at 6 months~   "
121041|NCT01983150|"~     The primary aim of this study will be to determine the effectiveness of a smartphone~     delivered app for young adult smokers on quitting smoking.~   "
121042|NCT01983137|"~     This non-interventional, observational study evaluates the efficacy of Targinact with regard~     to pain relief in daily clinical practice in Belgium compared to the previous analgesic~     treatment.~   "
121045|NCT01983098|"~     Colorectal cancer (CRC) is the third of the most common cancers and the second leading cause~     of cancer death in western countries. CRC is diagnosed at metastatic stage in approximately~     35% of cases, while about 20% to 50% of patients diagnosed at earlier stage (stage II and~     III) will develop distant metastasis subsequently. Treatment efficacy is usually evaluated by~     computer tomography (CT) scan with RECIST criteria and dosage of carcinoembryonic antigen~     (CEA) and carbohydrate antigen (CA) 19-9, which were performed every two weeks during the~     chemotherapy. The management of treatment for metastatic CRC need the development of early~     biomarkers to evaluate the efficacy in order to avoid unnecessary toxicity in case of early~     chemotherapy resistance. In this prospective study, the investigators will compare the~     monitoring of circulating tumor DNA with the results of CT scan according the RECIST criteria~     and the blood level of CEA and CA 19-9. The investigators carried out a microfluidic digital~     polymerase-chain-reaction (PCR) assay to measure the specific somatic genomic alterations in~     plasma to identify the circulating tumor DNA.~   "
121046|NCT01983085|"~     This is a study to assess the safety and efficacy of a nitric oxide (NOx) generating dressing~     on superficial partial thickness (SPT) wounds. Nitric oxide has a range of effects on the~     body including vasodilation and angiogenesis. It is also a potent antimicrobial. This 160~     patient, randomised, controlled clinical study will assess the ability of a simple 2 part,~     NOx generating dressing to improve healing in SPT burn wounds and SPT skin graft donor site~     wounds compared to standard of care.~   "
121047|NCT01983072|"~     The clinical trial aims at showing efficacy of prebiotics and the probiotic on microbiota~     balance. Together, the prebiotic solution in combination with the probiotic is expected to~     harmonize the microbiota of formula fed neonates with the microbiota of breast fed neonates~     and to allow a greater diversity of Bifidobacteria species in comparison with a formula~     non-supplemented with pre and probiotics.~   "
121048|NCT01983059|"~     The Liver Venous Thrombosis Study is a prospective observational cohort study aimed at~     collecting clinical data, patient reported outcomes and biological samples of all patients~     who have been newly and previously diagnosed with liver venous thrombosis in one of the~     participating hospitals in- and out-patient clinics of the participating centers in~     Switzerland. All new patients diagnosed with liver venous thrombosis or patients who are~     currently being treated in one of the participating centers, will be asked to participate in~     the study.~   "
121049|NCT01983046|"~     Gut microbiota is being increasingly recognized as an important factor in fat distribution,~     insulin sensitivity and glucose and lipid metabolism. Accordingly, the intestinal microbiota~     could play an important role in the development of obesity and type 2 diabetes mellitus. The~     role of gut-derived short-chain fatty acids (SCFA), the formation of which is enhanced by~     microbial fermentation of fiber, is still controversial. One study found that an increase in~     the formation of SCFA stimulated energy extraction from diet, with subsequent weight gain. In~     contrast, supplementation of non-fermentable carbohydrates, which lead to an increase in SCFA~     formation, had beneficial effects on body weight control and insulin sensitivity. Of note, a~     study showed that butyrate supplementation in mice prevented diet-induced obesity and insulin~     resistance. At the present time, our understanding of the effects of SCFA on human metabolism~     (in gut or systemically) is still limited. Yet, in light of the health claims of certain~     dietary fibers (prebiotics), a detailed picture of the physiology of human SCFA metabolism~     and its interaction with the microbiome is of pivotal importance. We hypothesize that the~     differential availability of SCFA impacts human metabolism differently. To determine whether~     rectal administration of SCFA is a good model for studying the metabolic effects of SCFA we~     first have performed a pilot study (METC 11-3-079). In this pilot study we have determined if~     rectal administration of sodium acetate has the same effects on substrate and energy~     metabolism compared to proximal administration. Our results indicate that the primary outcome~     parameter fat oxidation was significantly changed during post-absorptive conditions, when~     sodium acetate in a concentration of 180mM was administered in the distal part of the colon.~     In contrast, no effect on energy expenditure or substrate oxidation was seen when sodium~     acetate was administered in the proximal colon. Consequently, the distal part of the colon~     seems to be a good model to determine effects of gut-derived SCFA on the human substrate and~     energy metabolism. Therefore, we will administer in this study the SCFA rectally by using~     enemas. We will administer different combinations of SCFA to healthy, overweight male~     volunteers and examine effects on metabolism. This study is an important part of a~     Gastrointestinal Health TIFN project (GH003 WP 1.2), which will provide more insight in how~     increased availability of a beneficial SCFA mixture might serve as a basis for rational~     nutritional strategies in the prevention and treatment of obesity and type 2 diabetes~     mellitus. To obtain rational nutritional strategies, a next step in this TIFN project will be~     focusing on dietary ingredients modulating intestinal microbiota and subsequent SCFA~     production.~   "
121050|NCT01983033|"~     Repetitive negative thinking (RNT) plays an important role in different psychiatric~     disorders, such as depressive and anxiety disorders, complicated grief, posttraumatic stress~     disorders, anorexia nervosa. RNT is seen as a vulnerability factor in the onset, duration,~     severity and relapse of those disorders. Although there is a lot of theoretical research, it~     is unknown if a group training protocol addressing RNT has an additional effect on Treatment~     as Usual (TAU) of patients with GAD or Depressive disorder. Our hypothesis is that a training~     intervention will show a significant effect on declined RNT activity (measured by PSWQ and~     LARRS), reduced identification with worrying/rumination (measured by CFQ-13 and a Visual~     Analogue Scale), and reduced scores on metacognitions questionnaire (MCV Dutch version of the~     MCQ), when compared to TAU (medication, psychotherapy or a combination of both treatments).~     Further we expect that this effect on RNT will not be temporary and the beneficial effects~     will remain present over a longer time (9 months). Our third hypothesis claims that reduced~     RNT will have an effect on Quality of Life, self-esteem and depressive and anxiety scores~     (measured respectively by WHO-QoL, Rosenberg Self Esteem Questionnaire, BDI-II and STAI; all~     of them in Dutch version). Fourth hypothesis concerns the effect of the training in the~     functioning on a neurobiological level. Here we expect that the beneficial effects of~     training on RNT will increase top-down prefrontal (dorsolateral) cortical control over an~     overactive bottom-up limbic system. To examine these neurobiological effects, we apply a~     multimodal approach where we combine resting state fMRI, structural MRI such as diffuse~     tensor imaging (DTI), anterior spin labelling (ASL). Further, in our department we developed~     an audio critique task where participants hear different kinds of critique amongst some of~     negative valence which will be especially problematic for ruminative patients reflecting~     difficulties and differences these top-down/bottom-up processes when compared to a healthy~     control group at baseline. Further, we hypothesize that only when coping with RNT is~     successful these neuronal processes will normalize. We do not expect changes in the waiting~     list group.~      To examine these clinical and neuronal effects, people suffering from GAD and/or depression~     will be allocated by randomisation to an active treatment condition (ATC) and a waiting list~     control group (WLC). All the participants will be patients treated by general practitioner,~     psychologist or psychiatrist. Training exists of 8 sessions in group (max 12 participants) on~     a weekly basis, except for the last session, which takes place after one month). During the~     training people will get information on RNT, they will be trained in re-allocation of their~     attention, will receive some basic ideas about becoming aware of dysfunctional thinking and~     learn coping strategies such as stimulus control and engaging in positive activity.~      Assessments will take place before and after treatment for the ATC. The WLC will be measured~     at the start of the WLC and 12 weeks later. Measurement takes place by means of~     questionnaires and fMRI. During the fMRI, people will undergo a resting state paradigm and~     some tasks triggering RNT. 3 and 9 months after the group treatment, participants will be~     evaluated again on RNT by means of questionnaires. Participants in WLC will receive group~     treatment from the moment the parallel active treatment condition is ended (e.g. after 12~     weeks). This group will be evaluated immediately after training and at 3 and 9 months~     follow-up.~      At the end of the training, after the 8th session, two participants per run will be asked to~     cooperate in a qualitative in-depth interview. We are interested in linking results with the~     group training with some factors such as quantity of sessions, degree of active participation~     in between sessions. We are also interested in defining which interventions are perceived as~     most useful and if there is a link between disorder and the usefulness of some interventions.~   "
121051|NCT01983020|"~     This study has been designed as a controlled clinical trial to evaluate the efficacy of brief~     lidocaine infusion, brief ketamine infusion and a lidocaine/ketamine combined infusion when~     added to conventional opioid therapy following major spine surgery, as well as to evaluate~     the effects of the lidocaine/ketamine pain protocol on the feasibility of performing routine~     intraoperative neurophysiology during spine surgery in adults and determine whether this~     infusion protocol is compatible with intraoperative neurophysiology on spine surgery~     patients. If one or more of the approaches is confirmed as efficacious and safe, it could~     have a significant impact on the routine management of postoperative pain in this context.~   "
121052|NCT01983007|"~     Endothelial dysfunction precedes the development of cardiovascular disease and it is common~     in patients with diabetes mellitus. The aim of this study is to identify the effect of two~     different physical training programs, using ultrasound techniques, on the endothelial~     function of patients with type 2 DM.~   "
121053|NCT01982994|"~     Observational research has linked physical activity with faster recovery, improved quality of~     life, and greater survival; however, little is known about the effects of physical activity~     in pre-operative, peri-operative, or post-operative treatment contexts and there is a need~     for interventions to improve patient outcomes across the cancer treatment continuum. Three~     propositions derived from basic research, epidemiological evidence, and clinical practice~     informed our intervention development efforts: (1) Patient outcomes will be enhanced by~     interventions that increase physical activity (i.e., standing, walking) across the cancer~     treatment continuum (i.e., pre-operative, peri-operative, post-operative). (2) Reducing~     sedentary behavior (i.e., seated or reclined activities involving minimal energy expenditure)~     will enhance patient outcomes both by increasing physical activity and by stimulating~     additional adaptive physiological responses to reduced sedentary time (responses which are~     independent of physical activity-induced responses). (3) Patients with gastrointestinal~     cancers often suffer functional limitations that limit their independence and their health~     behaviors are strongly influenced by the family environment so interventions that engage~     caregivers (e.g., spouses) will be more effective than those that target patients/survivors~     alone.~   "
121154|NCT01981668|"~     This study utilizes a conventional phase I study design with a '3+3 cohort expansion'~     design(15), to determine the maximum tolerated dose(MTD) of 1) Cabazitaxel, in Part A, and 2)~     Radiotherapy, in Part B. The determination of the MTD is given in Section 5.2, Definition of~     Dose - Limiting Toxicity. All patients who enter the study, and begin concurrent~     chemo-radiation are analyzable for the primary endpoint of the study.~   "
121054|NCT01982981|"~     Nowadays, it is common to ingest beverages other than plain water, which range from flavored~     with a low energy input to others of high input. In Mexico, flavored beverage ingestion is~     believed to be displacing plain water; this phenomenon is raising concern in the health~     sector, due to the relation between flavored beverage intake and the increase in obesity and,~     consequently, chronic diseases.~      Up until now, there is no instrument available to characterize the perception of the Mexican~     population's well-being, beliefs and knowledge regarding plain water ingestion, nor is there~     an instrument capable of quantifying the daily water ingestion.~      The purpose of this study is design and validate a questionnaire to identify and evaluate the~     perception of well-being (PWBQ) related to plain water consumption in a sample of adult men~     and women of the city of Cuernavaca.~   "
121055|NCT01982968|"~     This study will test the hypothesis that treatment with laparoscopic anti-reflux surgery in~     subjects with idiopathic pulmonary fibrosis (IPF) and abnormal gastroesophageal reflux (GER)~     will slow the decline of forced vital capacity (FVC) over 48 weeks.~   "
121056|NCT01982955|"~     This is a multi-center, open-label, randomized, Phase 1b/2 trial to determine the recommended~     phase 2 dose (RP2D) and to evaluate the efficacy in terms of progression free survival (PFS)~     of Tepotinib when used in combination with gefitinib in subjects with T790M negative, MET~     positive locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring~     epidermal growth factor receptor (EGFR) mutation and having acquired resistance to Prior~     EGFR-Tyrosine Kinase Inhibitor (EGFR-TKI) Therapy. This study has 2:1 randomization~     (Tepotinib/Gefitinib arm versus Chemotherapy arm).~   "
121057|NCT01982942|"~     This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study~     designed to evaluate the safety, tolerability and activity of ibudilast administered twice~     daily over a 96 week period in subjects with primary or secondary progressive multiple~     sclerosis who are currently untreated with long-term MS disease modifying therapy (DMT) or~     who are receiving either glatiramer acetate (GA) or interferon beta-1, any formulation~     (IFNβ-1A [Avonex, Rebif] or IFNβ-1B [Betaseron, Extavia]). Study drug or placebo will be~     administered to a total of 250 male and female subjects from 21 to 65 years old, inclusive,~     in two treatment groups. Randomization of subjects will be stratified by disease status~     (primary progressive multiple sclerosis or secondary progressive multiple sclerosis) and~     immunomodulating therapy status: current use of immunomodulating therapy or no current use of~     immunomodulating therapy.~      The study will consist of a screening phase (up to 30 days) followed by a treatment phase (96~     weeks) and a follow-up visit (1 month post Week 96 visit). Following the screening phase,~     subjects who continue to meet entry criteria will be randomly assigned to 1 of 2 treatment~     groups: doses up to ibudilast 100 mg/day or matching-placebo in a 1:1 ratio. Study drug will~     be administered twice daily (BID), e.g., ibudilast 50 mg or placebo taken in the morning and~     evening).~   "
121058|NCT01982929|"~     Patients at Mbarara Regional Referral Hospital (MRRH) in Uganda who present for routine~     caesarean sections often go without a set post-operative pain control regimen. Due to lack of~     established protocols and supplies of essential pain control medications are not reliable,~     upwards of 90% of women receive no postoperative pain control. There are regional techniques~     that are effective, easy to perform, low risk, and inexpensive. One of these techniques is a~     tranversus abdominis plane (TAP) block.~      A TAP block is a regional anesthesia technique that provides analgesia to the parietal~     peritoneum as well as the skin and muscles of the anterior abdominal wall [1, 3-7]. First~     described just over a decade ago, it has undergone modifications in technique, and has been~     shown to be useful in providing 12-24 hours of significant post-operative pain relief for a~     wide array of surgical procedures [2]. It is best used as the cornerstone of a multi-modal~     approach to pain control and combines well with oral and intravenous opioid and non-opioid~     medications.~      This is a technically straightforward procedure that involves injection of local anesthetic~     within the fascial plane located between the two deepest muscle layers (transversus abdominis~     and internal oblique muscles) of the lower abdominal wall. Given the simplicity of the TAP~     block and its long-lasting diminution in post-operative pain after many abdominal and pelvic~     surgeries, the incorporation of TAP blocks into post- caesarean section pain management~     should be considered as an achievable and simple remedy to the lack of reliable pain~     mediations after surgical delivery at MRRH.~      This is a study that examines the efficacy of tranversus abdominis plane (TAP) blocks in~     providing post-operative analgesia after caesarean section under spinal anesthesia at Mbarara~     Regional Referral Hospital (MRRH) in Uganda, Africa. We will look at the value of TAP blocks~     in supplementing a routinely used (when available) post-operative non-opioid oral analgesic~     regimen.~      Primary Hypothesis:~      The administration of a TAP block on completion of caesarean section will decrease the level~     of pain as measured by a visual Numerical Rating Score (NRS) at 8, 16 and 24 hours, both at~     rest and with movement.~      Secondary Hypotheses:~        1. The administration of a TAP block on completion of caesarean section will increase the~          satisfaction score at 8, 16, and 24 hours; and~        2. The administration of a TAP block will decrease or prevent the need for postoperative~          nurse- administered pethidine (meperidine) as a rescue medication.~      This is a prospective, randomized, double-blind, sham controlled, single-center trial. A~     total of 240 patients will be enrolled in the study.~      Following completion of the caesarean section, all patient will be screened for enrollment~     into the study. Enrollees will be randomly assigned to an arm via a predetermined undisclosed~     random number generator that will not be known by the staff at the MRRH. The anesthesiologist~     performing the TAP or sham block will be given a sealed envelope with the study arm which the~     patient has been randomized.~      The study procedure is a TAP block and it will be placed on 50% of the enrollees.~      TAP BLOCK:~      Physicians who have been fully trained on the performance and potential risks of the~     technique will place TAP blocks under ultrasound-guidance. Briefly, under sterile conditions,~     ultrasound will be used to identify the targeted abdominal fascial plane. Once located, a~     predetermined amount of local anesthetic will be injected. This will be performed,~     bilaterally. The patient will be monitored during the block and for 30 minutes to follow.~      SHAM BLOCK:~      Sham blocks will consist of a non-invasive ultrasound scan over the abdomen. To mimic the~     injection of medicine, a dull/blunt object will be gently pressed on either side of the~     abdomen. The patient will be monitored during the sham block and for 30 minutes to follow.~   "
121059|NCT01982916|"~     The purpose of this study is to evaluate treatment of perennial allergic rhinitis in Korean~     patients with AGR tablet.~   "
121060|NCT01982903|"~     The purpose of this study is to determine whether urinary connective tissue growth factor~     (uCTGF) can predict the onset of fibrosis in transplanted kidneys.~   "
121061|NCT01982890|"~     The Investigators have established a cohort of patients with recent-onset inflammatory~     arthritis called Early Undifferentiated PolyArthritis (EUPA). This cohort was established to~     define novel biomarkers of poor outcomes. We want to study telomere length and T-cell~     Receptor Excision Circles (TREC) numbers in peripheral blood as new biomarkers.~      This cohort of normal controls was established to be able to define the stability over short~     periods of time of telomere length and TREC numbers in normal individuals, in order to~     compare with arthritis patients.~   "
121062|NCT01982877|"~     The purpose of this study is to test the effectiveness of a multi-faceted communication~     intervention for family members of critically ill patients to reduce the family members'~     long-term symptoms of depression and anxiety.~   "
121063|NCT01982864|"~     Aminoglycosides are widely used for the treatment of Gram-negative bacilli and Staphylococcus~     aureus infections because of their effectiveness and low cost. Nevertheless, many aspects of~     their optimal use in hemodialysis patients remain unsolved and little is known about their~     pharmacokinetics in this context. The current practice for prescribing aminoglycosides to~     these particular patients consists in giving after each hemodialysis session about half the~     dose usually given to patients with normal renal function.~      However, theoretical considerations and emerging clinical data suggest that this may not be~     the most beneficial dosing regimen as efficient peak concentrations are often not attained~     and the occurrence of ototoxicity and nephrotoxicity is still frequent.~   "
121064|NCT01982851|"~     The purpose of this study is to determine if there is a difference in the duration of the~     first stage of labor in nulliparous women scheduled for an induction of labor, with whom~     analgesia is maintained with a combined spinal epidural (CSE) technique versus an epidural de~     novo technique. The investigators hypothesize that the duration of the first stage of labor~     will be no different in nulliparous patients who receive either intrathecal fentanyl or~     intrathecal fentanyl and bupivacaine, as part of a CSE technique. However, the duration of~     the first stage of labor will be shorter in parturients who receive intrathecal analgesia (as~     part of a CSE technique) compared to those who receive an epidural de novo technique with~     fentanyl and bupivacaine.~   "
121065|NCT01982838|"~     The purpose of this study is to determine if there is a difference in the duration of the~     first stage of labor in nulliparous women in spontaneous labor with whom analgesia is~     maintained with a combined spinal epidural (CSE) technique versus nulliparous women in~     spontaneous labor with whom an epidural de novo technique is utilized. The investigators~     hypothesize that the duration of the first stage of labor will be no different in nulliparous~     patients who receive either intrathecal fentanyl or intrathecal fentanyl and bupivacaine, as~     part of a CSE technique. However, the duration of the first stage of labor will be shorter in~     parturients who receive intrathecal analgesia (as part of a CSE technique) compared to those~     who receive an epidural de novo technique with fentanyl and bupivacaine.~   "
121185|NCT01981252|"~     This is prospective, multi-center, single-blinded, non-randomized clinical trial. Enrolled~     subjects will receive two Ulthera® treatments on the peri-orbital and peri-oral regions, each~     treatment provided 30 days apart. Follow-up visits will occur at 90 and 180 days following~     treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at~     each follow-up visit.~   "
121066|NCT01982825|"~     Tobacco use is the leading cause of cancer death in the U.S. Because smokers who quit by age~     30 have cancer death risk similar to non-smokers, promoting cessation early in life is~     critical. U.S. colleges/universities, enrolling >14 million students/year (40% of those aged~     18 to 24), are an important venue to reach young adult smokers. While daily tobacco use in~     the U.S. has declined to 18.1%, nondaily smoking (smoking on some days but not every day) is~     increasing, particularly among young adults and African Americans. Moreover, young smokers~     and nondaily smokers (half of young adult smokers), respectively, are less likely to seek~     help in quitting; thus, innovative strategies are needed to assist cessation early in life,~     particularly among those who may not be motivated to quit or seek help. Unfortunately, no~     research has focused on developing a cessation intervention that addresses a broad range of~     smoking patterns (nondaily to daily smoking) or diverse campus settings among ethnically~     diverse student populations. Web-based interventions offer promise in helping college~     students to quit, given high rates of Internet use and web capacity to provide tailored~     cessation messages. A novel approach to delivering cessation information via the web might be~     to address broader lifestyle issues and apply market research strategies to identify market~     segments of smokers (groups of people with similar interests, goals, values) in order to~     target and engage these groups more effectively. Applying this strategy to an online~     cessation intervention should enhance both intervention use and processing of intervention~     messages, leading to greater abstinence rates. The investigators aim to: (1) develop and~     refine a tailored web-based intervention for smoking cessation targeting college students~     with a range of smoking levels; (2) test the usability, acceptability, and feasibility of the~     intervention among college student smokers; and (3) determine the potential effect of the~     intervention on smoking cessation, smoking level, quit attempts, and contextual factors.~   "
121067|NCT01982812|"~     Pediatric cerebral malaria (CM) affects more than 3 million children each year killing ~20%~     and leaving one third of survivors with long term neurologic and psychiatric sequelae.~     Seizures occur commonly with CM and are associated with an increased risk of death and~     neuropsychiatric disabilities. In this Malawi-based, safety and feasibility study of enteral~     levetiracetam in pediatric CM, the investigators will lay the groundwork for future efficacy~     studies aimed at improving seizure control and ultimately decreasing the neurologic morbidity~     of pediatric CM.~   "
121068|NCT01982799|"~     For patients with a toothache, is pain relief after root canal procedure improved using long~     acting local anesthetic and analgesics? The purpose of this clinical trial is the investigate~     the effect of long acting local anesthetic with 1 of 4 oral medication groups, on~     post-operative endodontic pain.~   "
121069|NCT01982786|"~     This research is being done because investigators involved in this study would like to~     compare image guided external beam radiation therapy (IGRT) to IGRT plus HDR brachytherapy~     boost to see which treatment is better and what the side effects of treatment are.~   "
121070|NCT01982773|"~     A hope box or self soothing kit is a therapeutic tool employed by clinicians with patients~     expressing suicidal ideation, significant distress, or otherwise at risk of suicidal or~     non-suicidal self harm. A Virtual Hope Box (VHB) takes the common hope box practice and~     uses smartphone features to enhance the experience. The rich multimedia features on a~     smartphone allow more varied options. Furthermore, these devices are already a common~     repository for user-generated and user-preferred media, which will allow for a highly~     personalized VHB that is highly portable and always available to a user in distress. We~     hypothesize that:~        1. Patients in the (VHB) intervention condition will demonstrate pre-post reductions in 1)~          severity of suicidal ideation 2) ability to cope with stressors and 3) increases in~          perceived reasons for living~        2. Patients in the intervention condition will demonstrate greater pre-post reductions in~          symptoms of suicidal ideation, ability to cope with stressors, and perceived reasons for~          living compared to patients in the (ETAU) control condition.~        3. Patients and clinicians will find VHB to be beneficial and its use readily integrated~          into practice.~   "
121071|NCT01982760|"~     This is study looking at the use of a medication, Desmopressin acetate (DDAVP), to reduce~     bleeding, swelling, and bruising in patients undergoing cosmetic nose surgery. DDAVP is a~     drug used in patients with bleeding disorders. It works by activating molecules in the blood~     stream called platelets that promote clotting. In the study, participants who are have~     cosmetic nose surgery (rhinoplasty) will be randomly assigned to receive or not receive~     medication. Photographs taken before and shortly after surgery will be evaluated for the~     amount of bruising and swelling. Patients with heart, lung, kidney, or liver problems are not~     eligible to participate.~   "
121072|NCT01982747|"~     MGN1703 is being developed for use in treating cancerous tumors effecting the colon, skin,~     kidneys and lungs. The dosage form of MGN1703 under investigation is an injection.~      The goal of this study is to evaluate the effects of MGN1703 on the electrical activity of~     the heart in healthy subjects and to look at general safety.~   "
121073|NCT01982734|"~     Curcumin, a lipophilic polyphenol derived from the plant curcuma longa possesses numerous~     health-promoting activities. The oral bioavailability of curcumin is low due to its poor~     aqueous solubility, limited gastrointestinal absorption, rapid metabolism and excretion.~     Therefore, we tested, in a randomized crossover study, simultaneous application of~     phytochemicals and micellar solubilisation, alone and together, as strategies to enhance the~     absorption of curcumin into the body. Furthermore, we investigated age and sex differences in~     curcumin pharmacokinetics.~   "
121074|NCT01982721|"~     The investigators hypothesize that a new automatic prosthetic knee locking mechanism will~     improve gait characteristics during an induced controlled trip and reduce fear of falling.~   "
121075|NCT01982708|"~     The study hypothesis is a haptic sensor can aid in the evaluation of the acute abdomen.~     Investigators from the MSU Department of Surgery in Collaboration with MSU Engineering are~     assessing the ability of a non invasive, optical device that is placed on a patients abdomen~     (much like an ultrasound transducer) to evaluate a patient with an acute abdominal~     presentation. Conditions such as appendicitis, cholecystitis, diverticulitis or small bowel~     obstruction will be examined with the haptic device. Data will be collected by the device and~     later compared to the abdominal findings recorded from an examination conducted by the~     principle investigator who is a surgeon. The surgeon will not have acess to data collected by~     the haptic sensor and therefore it will have no impact on the decision making process in the~     care of the patient. The impact on the individual patient will require obtaining a consent to~     participate in the study, a few minutes to place the device gently on the abdomen and collect~     the sensor data. There is no direct benefit to the patient by participating in the study. The~     potential for such a study may be to develop the technology to have a device that non-medical~     staff can use to collect patient data and transmit that data to a healthcare provider at~     another location.~   "
122043|NCT01970033|"~     SP2086 is a new dipeptidy1 peptidase(DPP)-4 inhibitors. This study aims to evaluate the~     efficacy and safety of SP2086 as monotherapy in patients with Type 2 Diabetes Mellitus in~     Metformin monotherapy Who Have Inadequate Glycemic Control treated with diet and exercise for~     3 months~   "
121076|NCT01982695|"~     This trial is a double-blind randomized clinical trial of lisinopril versus losartan for the~     treatment of cardiomyopathy in Duchenne Muscular Dystrophy (DMD). Both drugs are known to be~     effective for the treatment of dilated cardiomyopathy. ACEi have been reported to delay the~     onset and progression of left ventricle dysfunction in children with DMD. Multiple studies~     show therapeutic efficacy of losartan in animals with cardiomyopathy related to muscular~     dystrophy and in patients with cardiomyopathy from diverse causes. ARBs are often reserved~     for patients in whom heart failure is not adequately treated or where side effects preclude~     the use of an ACEi. However, in DMD, losartan might be a better choice as a first line drug~     because of studies demonstrating a potential benefit for skeletal muscle in the mdx mouse.~     Considering that both skeletal and cardiac muscles are major contributors of the disability~     of DMD, a drug that could improve both heart and skeletal muscles simultaneously would need~     consideration as the drug of choice for the cardiomyopathic DMD patient.~   "
121077|NCT01982682|"~     This phase II trial studies how well total-body irradiation, donor lymphocyte infusion, and~     cyclophosphamide before donor stem cell transplant works in treating patients with high-risk~     hematologic malignancies. Giving total-body irradiation, donor lymphocyte infusion, and~     chemotherapy before a donor stem cell transplant helps stop the growth of cancer and abnormal~     cells and helps stop the patient's immune system from rejecting the donor's stem cells. When~     certain stem cells from a donor are infused into the patient they may help the patient's bone~     marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the~     transplanted cells from a donor can make an immune response against the body's normal cells.~     Removing the T cells from the donor cells before transplant and giving tacrolimus and~     mycophenolate mofetil may stop this from happening.~   "
121078|NCT01982669|"~     Excess dietary salt intake is closely associated with the development of hypertension and~     cardiocerebral vascular diseases. Reduction in high salt intake significantly prevents~     hypertension and cardiocerebral events. Currently, few promising method is available to~     reduce salt intake in human. This study focus on examining the salty taste in~     population-level and exploring whether dietary factors can reduce salt intake through acting~     on salty taste.~   "
121079|NCT01982656|"~     This research study seeks to explore the effects of massage techniques on pain and anxiety~     relief among patients with subarachnoid hemorrhages in the ICU setting in comparison to~     subarachnoid hemorrhagic patients using standard medical therapy. In addition, our aim is to~     decrease the overall medication use to treat pain and anxiety, and to determine the impact of~     massage on sleep duration, quality, and breathing. Our goal is to improve and promote comfort~     during the ICU stay as well as decrease the need for narcotic medication usage.~   "
121080|NCT01982643|"~     The aim of this 2-stage, 3-site study is to investigate the effectiveness and safety of a~     combination of extended-release depot naltrexone plus extended-release bupropion as a~     potential pharmacotherapy for methamphetamine (MA) use disorder.~   "
121081|NCT01982630|"~     This study will evaluate the safety, efficacy, and pharmacokinetics of MK-8521 given once~     daily compared to placebo and another diabetes drug in participants with Type 2 diabetes~     mellitus (T2DM).~      This study was modified by a protocol amendment to a 2-part trial to further test the safety~     and tolerability of MK-8521 at higher doses and to compare MK-8521 pharmacokinetics between~     participants with T2DM and healthy participants. An additional cohort of T2DM participants~     and a cohort of non-diabetic obese participants have been added.~   "
121082|NCT01982617|"~     The investigators primary hypothesis was that recipients of the Motivational Interviewing~     intervention would be significantly more likely than those assigned to the Psychoeducation~     intervention to demonstrate increased readiness to quit smoking at the end of the~     intervention and to seek smoking cessation treatment in the one month period following the~     intervention. We also predicted that the Psychoeducation intervention would result in greater~     improvements in smoking knowledge.~   "
121083|NCT01982604|"~     A Phase 1, open-label randomized crossover trial in Healthy Volunteers to evaluate the PK/PD~     of TI (Technosphere® Insulin) prepared with insulin from two different suppliers.~   "
121084|NCT01982591|"~     This research trial studies heavy metal exposure in predicting peripheral neuropathy in~     patients with stage I-III breast cancer undergoing chemotherapy. Studying samples of blood~     and urine in the laboratory for heavy metal exposure from patients receiving chemotherapy may~     help doctors find out whether side effects from chemotherapy are related to heavy metal~     exposure.~   "
121085|NCT01982578|"~     Genistein is an isoflavone that has antioxidant and neuroprotective effects on Alzheimer's~     disease (AD).~      A few years ago our group reported that genistein increased PPARg (peroxisome proliferator~     activated receptor gamma) levels. By the way, activation of retinoid X receptor (RXR)-PPARg~     dimer, will make overexpressing apolipoprotein E (apoE), which mediates the degradation of~     amyloid beta (AB). Therefore, we believe that if this phytoestrogen administration increases~     the availability of the transcription factor, it can increase apoE, and also AB degradation.~      The main aim of this study is to determinate the effect of 60 mg BID of genistein~     administration, during 180 days, compared to placebo group, in AD patients.~   "
121086|NCT01982565|"~     This is a 2 part study to assess the safety and efficacy of a nitric oxide (NOx) generating~     dressing on chronic diabetic foot ulcers (DFU). Nitric oxide has a range of effects on the~     body including vasodilation and angiogenesis. It is also a potent antimicrobial. This 140~     patient, randomised, controlled clinical study will assess the ability of a simple 2 part,~     NOx generating dressing to increase blood flow in DFUs and to improve healing in chronic DFUs~     compared to standard of care.~   "
121087|NCT01982552|"~     The purpose of this study is to document quality of life, patient satisfaction, effect on~     itching, and control of psoriasis vulgaris associated with use of calcipotriene/betamethasone~     dipropionate (Taclonex®) topical suspension 0.005% / 0.064% for treatment of plaque psoriasis~     under real-life conditions.~   "
121088|NCT01982539|"~     As part of the PREA(Pediatric Research Equity Act) commitment, the objective of the study is~     to confirm safety and tolerability of 25 mg of Zipsor® in clinical pediatric subjects.~   "
121089|NCT01982526|"~     Ovarian reserve influenced by many factor but especially cysts like endometrioma. Anti~     mullerian hormone is recent marker for ovarian reserve. The investigators are searching~     ovarian reserve pre and post operatively by using antimullerian hormone of endometrioma~     patient who are operated for their cysts.~   "
121090|NCT01982513|"~     Cardiac arrest during pregnancy is rare but may result in poor maternal and fetal outcome.~     Because of its rare occurrence and ethical issues this topic is not very well studied and~     many questions pertaining to maternal resuscitation remain unanswered. One of the challenging~     aspects of cardiopulmonary resuscitation in a term pregnant patient is the ideal positioning~     during chest compressions. International societies have made recommendations regarding~     management of pregnant patients during cardiac arrest. They advocate the use of left lateral~     position with 30 degrees tilt or manual uterine displacement. However these recommendations~     are not based on high level of evidence. Ultrasound has been used to visualize the change in~     diameter of great vessels to determine the volume status or adequacy of blood circulation of~     these patients. This approach can be used to study the adequacy of blood circulation of~     pregnant patients in different positions. The objective of this study is to compare the~     change in Inferior vena cava diameter obtained with pregnant women in either the left lateral~     tilt or in the supine position with a manual uterine displacement, compared to the left~     lateral position and the supine position.~      Our hypothesis is that the inferior vena cava diameter obtained in the supine position with~     manual left uterine displacement would be larger as compared to that obtained with women~     positioned with a 30-degree tilt.~   "
121091|NCT01982500|"~     Investigators propose to assess,the safety and tolerability profile (number of participants~     with adverse events) of bevacizumab (Avastin) when added to chemotherapy as front-line~     treatment of epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal~     carcinoma~   "
121092|NCT01982487|"~     This partially randomized phase I/IIb trial studies the side effects vaccine therapy and~     indoleamine 2,3-dioxygenase (IDO1) inhibitor 4-amino-1,2,5-oxadizaole-3-carboximidamide~     (INCB024360) and to see how well they work in treating patients with epithelial ovarian,~     fallopian tube, or primary peritoneal cancer who are in remission. Vaccines made from~     gene-modified virus may help the body build an effective immune response to kill tumor cells.~     IDO1 inhibitor INCB024360 may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Giving vaccine therapy with IDO1 inhibitor INCB024360 may be an~     effective treatment for epithelial ovarian, fallopian tube, or primary peritoneal cancer.~   "
121093|NCT01982474|"~     The purpose of this study is to determine safety of allergy immunotherapy lymph node~     injections for grass pollen allergies.~   "
121094|NCT01982461|"~     The objective of this trial is to assess the efficacy of reducing plasma low-density~     lipoprotein(LDL) cholesterol and safety in two different brand drugs, Roty F.C. Tablets 10mg~     and Crestor 10mg F.C. Tablets in hypercholesterolemia population.~   "
121095|NCT01982448|"~     This research study is evaluating how well triple negative breast cancer responds to~     preoperative treatment with Cisplatin or Paclitaxel chemotherapy, and if use of a research~     test Homologous Recombination Deficiency (HRD) assay can predict response to preoperative~     treatment.~   "
121096|NCT01982435|"~     The primary objective of the study is to assess the ocular and systemic adverse events of~     ranibizumab (Lucentis)for DME (diabetic macular edema) following previous treatment with~     intravitreal bevacizumab (Avastin).~   "
121097|NCT01982422|"~     This is a study evaluating the relationship between prenatal nutrition and neural development~     in infants born to mothers with Attention Deficit Hyperactivity Disorder (ADHD). We are~     hypothesizing that women randomized to a whole food, nutrient-dense diet during their 3rd~     trimester of pregnancy will have infants with more advanced neural development as compared to~     infants born to mothers receiving standard-of-care treatment.~   "
121098|NCT01982409|"~     The purpose of this study is to observe the persistence of protection, duration of~     protection, safety and breakthrough infection rates afforded by live attenuated varicella~     vaccine in children over a 5-year period.~   "
121099|NCT01982396|"~     Cross-over 28 week study of the plasma pharmacokinetic profiles of twice daily 3TC~     (4mg/kg/dose BD) with once daily 3TC (8mg/kg/dose OD) and twice daily ABC (8mg/kg/dose BD)~     with daily ABC (16mg/kg/dose OD) where one or both drugs are being taken as part of~     combination antiretroviral therapy.~   "
121100|NCT01982383|"~     The investigators hypothesis is that using the micropulse laser in patient with Central~     Serous Chorioretinopathy (CSC) will prompt resolution of CSC and will be effective in~     significantly minimizing visual recovery time from this disease as well as potentially~     preventing recurrences.~   "
121101|NCT01982357|"~     Alterations to microvascular blood flow in premature infants, are known to contribute to~     several major disease entities.~      The optically-measured tissue blood flow, to determine tissue perfusion that can be use to~     detect blood loss.~   "
121102|NCT01982344|"~     To compare the effect of mini-exchange-room and usual care on physical activity and quality~     of life in peritoneal dialysis (PD) patients through a randomized controlled study. A total~     of 80 incident CAPD patients with age of 18~80 years old will be enrolled, who are medically~     stable and regularly followed up. The one group perform traditional PD procedure (G1), and~     the other group will utilize disposable mini-exchange-room group (G2). Two groups will be~     followed for 6 months. Biochemistry data, types of space for bag exchange, physical activity~     and quality of life will also be collected for all subjects at the 3rd and 6th month. During~     the study period, peritonitis episode, acute comorbidity and hospitalization will be~     recorded. The change of physical activity, quality of life and peritonitis rate will be~     compared between the two groups.~   "
121103|NCT01982331|"~     This is a phase I study to evaluate the safety of a vaccine to protect against influenza~     viruses of the H2N2 subtype. A total of 40 adults will be enrolled and receive two doses of~     vaccine or placebo one month apart.~   "
121104|NCT01982318|"~     The objective of this study is to assess the efficacy and safety of VitroGro® combined with~     standard care in the treatment of Venous Leg Ulcers (VLUs) compared to Placebo with standard~     care over the course of the 8-week treatment phase.~   "
121105|NCT01982305|"~     The purpose of this study is to determine whether an ultrasound-guided nerve block simulator~     is effective for the training of the axillary block technique.~   "
121106|NCT01982292|"~     The purpose of this study was to assess the safety of repeat doses of serelaxin in chronic~     heart failure.~   "
122044|NCT01970020|"~     The purpose of the study is to investigate the absorption, metabolism, and excretion of 14C~     JNJ-38518168 in healthy adult male participants after a single oral dose of 30 mg 14C~     JNJ-38518168.~   "
121107|NCT01982279|"~     Objectives: The aims were to measure one year change in caloric compensation (CC) and eating~     in the absence of hunger (EAH) in 3 to 6 year-old French children in their regular eating~     context and to link these change with individual characteristics (adiposity, age, gender) and~     maternal feeding practices.~      Three series of measurements of caloric compensation (CC) and eating in the absence of hunger~     (EAH) were conducted: at baseline, and 3 (FU3M) and 15 (FU15M) months later. Each serie of~     measurement was composed of three consecutive weeks an identical lunch was served in four~     preschool canteens reaching 236 children. The first lunch was a control session. For the CC~     situation (week 2), thirty minutes before the lunch children were offered a preload (137~     kcal). For the EAH situation (week 3), ten minutes after lunch children were exposed to~     palatable foods (430 kcal). Food intake was measured at the individual level. Maternal eating~     behaviour and feeding practices were measured by questionnaires. Child's height and weight~     were measured by a medical doctor.~   "
121108|NCT01982266|"~     This is a prospective, multicenter, single arm feasibility study of the safety and~     performance of the GRADION™ Hip Total Cartilage Replacement (TCR)™ in patients who require~     cartilage replacement.~   "
121109|NCT01982253|"~     To evaluate the efficacy of fasiglifam 25 mg twice daily (BID) and fasiglifam 50 mg once~     daily (QD) on glycemic control in adults with type 2 diabetes who are inadequately controlled~     on diet and exercise alone.~   "
121110|NCT01982240|"~     The purpose of this study is to confirm that the investigational medication, plecanatide, is~     safe and effective in treating chronic idiopathic constipation.~   "
121111|NCT01982227|"~     Between 30% and 40% of patients with colorectal cancer develop metastatic disease~     intraperitoneally. The optimal treatment of this disease combines surgery and chemotherapy~     but requires resection of all lesions larger than 2mm.~      Indocyanine green has an affinity for tumor tissues and the interest of its use has been~     demonstrated for the detection of sentinel lymph node and some liver surgeries.~      The ability of indocyanine green to detect peritoneal carcinomatosis in humans has never been~     evaluated.~      This study aims to evaluate the diagnostic performance of fluorescence in the detection of~     malignant cells in peritoneal carcinomatosis of colorectal origin compared with pathological~     analysis.~   "
121112|NCT01982214|"~     A controlled, non-randomized trial will be carried out in 240 postmenopausal women, aged~     55-75 years, over a 18-month period. The group 1 received a physical intervention, consisting~     of whole body vibration (WBV) over 12 months followed by training arrest during 6 months. The~     group 2 served as sedentary control. WBV training is performed 2 or 3 times per week, with~     each session lasting 20 minutes. The training included light squats at 35-50 Hz and ended up~     by stretching and relaxation exercises at 50 Hz. Bone, muscle and postural evaluations will~     be performed at the beginning, 6, 12 and 18 months in each group with evaluation of bone~     micro-architectural trabecular and cortical compartments, at the weight bearing tibia and the~     non weight bearing radius.~      The primary outcome of the project is the pre, mid, and post evaluations of bone. Bone~     exploration included dual x-ray absorptiometry (DXA) and high resolution peripheral~     quantitative computed tomography (HR-pQCT). Bone Mass Density (BMD) will be evaluated by DXA~     at lumbar, femoral levels and humeral, macro and micro-architectures of the cortical and~     trabecular compartments will be evaluated in distal radius and tibia by HR-pQCT and bone~     markers will be analyzed longitudinally. The secondary aim is to assess muscle performance~     and proprioception. Finally will be assessed markers of cartilage degradation and synthesis,~     no study has been published on this tissue.~   "
121113|NCT01982201|"~     This study will assess the potential effects of calcium carbonate and aluminum/magnesium~     hydroxide-containing antacids on the pharmacokinetics (PK) and pharmacodynamics (PD) of~     lesinurad in healthy, adult male subjects.~   "
121114|NCT01982188|"~     This study was designed to evaluate urinary function before and one year after single~     incision sling placement at the time of robotic sacrocolpopexy. The thought is that the more~     minimally-invasive, single incision sling would provide a similar subjective success rates as~     those of retropubic and trans-obturator slings.~   "
121115|NCT01982175|"~     This is a phase II, prospective, multicenter, open-label study to evaluate the efficacy and~     safety of Alemtuzumab in patients with relapse and refractory B-cell chronic lymphocytic~     leukemia.~   "
121116|NCT01982162|"~     Cross-sectional study to characterize cohorts of children with asthma and healthy controls in~     terms of clinical features, physiological measurements and non-invasive measurement of~     biomarkers and develop phenotype handprints for children with severe asthma~   "
121117|NCT01982149|"~     Lung cancer, largely the result of cigarette smoking, is the leading cause of cancer death in~     the United States, killing over 160,000 people in 2010, more than breast, colorectal, and~     prostate cancer combined. Since only 10% of heavy smokers develop lung cancer and 20% of lung~     cancers develop in nonsmokers, it is thought that genetic predisposition plays an important~     role. This study proposes to examine the genetic correlation between nasal and bronchial~     epithelium and to identify a patient's risk for lung cancer earlier.~   "
121118|NCT01982136|"~     The analysis of the long-term outcomes and quality-of-life parameters after urethral~     reconstruction surgery.~   "
121119|NCT01982123|"~     This pilot clinical trial studies single photon emission computed tomography (SPECT)/computed~     tomography (CT) in measuring lung function in patients with cancer undergoing radiation~     therapy. Diagnostic procedures that measure lung function may help doctors find healthy lung~     tissue and allow them to plan better treatment.~   "
121130|NCT01981980|"~     Carboxytherapy (CA) refers to the cutaneous and subcutaneous administration of carbon dioxide~     gas [CO2] for therapeutic purposes. Radiofrequency (RF) is a method that uses electric~     current to generate heat into the layers of the skin and the subcutaneous tissue. Both~     techniques are indicated to the treatment of skin laxity. The aim of this study was to~     compare the effects of CA an RF on human skin. Methods: Eight patients who underwent~     abdominoplasty surgery received a single procedure of both treatments. Untreated skin was~     used as control. In an area of 49 cm2 (7 x 7 cm) in the infra-umbilical region CA was~     performed on the right and RF on the left side. Sample collection period ranged from zero to~     120 days. CA was administered at a velocity of 40 ml/min, and the total quantity of CO2~     infused was approximately 20ml. RF was carried out in a temperature higher than 40ºC on the~     epidermis for 5 minutes after reaching this temperature.~   "
121120|NCT01982110|"~     Cigarette smoking is the leading cause of preventable death and disability in the world.~     Although over 70% of smokers want to quit, fewer than 5% achieve this goal annually.~     Additional effective, safe, and accessible treatments for nicotine dependence are needed due~     to the low abstinence rates (20-30%) achieved in behavioral therapies, the unappealing side~     effects of pharmacotherapy, and the frequent lack of accessibility to treatment. Recent~     evidence supports the central role of craving in maintaining nicotine dependence, and neither~     behavioral nor replacement therapies directly target the relationship between cravings and~     smoking. Mindfulness therapy has been found to be effective in teaching strategies to~     decouple the association between craving and smoking. Mindfulness based smoking therapy (MT)~     has preliminary support for reducing consumption in smokers, and Dr. Judson Brewer has~     recently translated this program into a mobile device application (app) for smoking~     cessation. With Dr. Brewer's consultation, we propose to assess the feasibility of~     implementation of a MT mobile application in local hospital and community clinics and the~     effectiveness of the MT mobile application compared to a National Cancer Institute (NCI)~     QuitPal behavioral change group. We will examine smoking results at end of treatment and 2~     and 6 month follow-up as well as the role of craving. If MT smoking cessation is determined~     to be effective in a mobile phone application, this finding will be a significant step in~     providing an additional effective and safe treatment for smokers wishing to quit or cut down~     on their intake, and will be especially important in providing treatment options for~     marginalized or hard-to-access individuals wishing to reduce cigarette intake.~   "
121121|NCT01982097|"~     This local, prospective, multicenter, non-interventional study documents observational data~     on patients under routine treatment of metastatic RCC with Nexavar before and after~     cytoreductive nephrectomy. It's planned to better understand the impact of cytoreductive~     nephrectomy on Nexavar efficacy and possibly to define patients who get the most benefit from~     Nexavar before cytoreductive nephrectomy.~   "
121122|NCT01982084|"~     Group B Streptococcus (GBS) is the commonest cause of severe infection and meningitis in~     babies under 3 months in the United Kingdom (UK). About one in ten babies with GBS infection~     die and half of babies with GBS meningitis are left with long term problems with their~     development.~      Vaccinating pregnant women against GBS in order to protect their newborn babies is a~     promising area of research.However, many women are reluctant to accept vaccination during~     pregnancy for fear it will harm their unborn child and there is often a lack of understanding~     of both the vaccine and the condition it aims to prevent. Nevertheless, the recent positive~     experience of immunisation against pertussis in the United Kingdom, suggest that antenatal~     immunisation can be acceptable.~      Previous research has shown that advice from maternity healthcare professionals regarding~     vaccination is highly valued by pregnant women so it is also important to explore the~     attitudes and opinions of this group.~      The objective of this study is to assess the knowledge and attitudes of pregnant women and~     maternity healthcare professionals in England and Scotland regarding GBS disease and the~     acceptability of a potential vaccine.~      There are two parts to this study. The first part will invite pregnant women, maternity~     healthcare professionals and parents who have had a child affected by GBS disease to take~     part in either a focus group or an individual interview.~      This will allow for an in-depth exploration of the participants thoughts and opinions about~     GBS and vaccination in pregnancy. This part of the study will take place at the Oxford site~     only. The results will guide the development of a self completed, paper questionnaire which~     will be distributed to a wider range of pregnant women and maternity healthcare professionals~     across four different study sites.~      This study has been funded by Meningitis UK. Additional collaborators to those listed include~     the charity Group B Strep Support.~   "
121123|NCT01982071|"~     To evaluate the efficacy and safety of intravenous micafungin for the treatment of patients~     with proven or probable fungal infections caused by Candida sp. (Fungemia, respiratory~     mycosis, gastrointestinal mycosis) in adult patients in China.~   "
121124|NCT01982058|"~     RATIONALE: Participating in a therapy program may enhance communication and intimacy between~     men with prostate cancer and their partners.~      PURPOSE: This randomized clinical trial is studying how well therapy enhances communication~     and intimacy for men with early stage prostate cancer and for their partners.~   "
121125|NCT01982045|"~     The purpose of this study is to demonstrate the non-inferiority of AttraX® Putty as a bone~     graft substitute for autograft in instrumented posterolateral fusion of the thoracolumbar~     spine, in terms of efficacy and safety.~   "
121126|NCT01982032|"~     Transcatheter aortic valve replacement (TAVR) is a good alternative treatment for patients~     with severe aortic valve stenosis with similar mid-term success rates as compared to surgery.~     Periprosthetic aortic regurgitation (PAR) after TAVR remains an important limitation of this~     technique. Moderate to severe PAR occurs in 15-45% of the cases and it is an independent~     predictor of mortality after TAVR. Little is known about potential differences in severity of~     PAR among different types of aortic valve prosthesis. The current randomized study aims to~     evaluate potential differences between the Edwards SAPIEN bioprosthesis and the Medtronic~     CoreValve® system with main focus on PAR and additional focus on other clinical and imaging~     endpoints. Primary objective of this study is to investigate the difference in the severity~     of PAR, measured with 3-dimensional transesophageal echocardiography (3DTEE), between~     patients undergoing the implantation of the Edwards SAPIEN bioprosthesis versus patients~     receiving the Medtronic CoreValve® bioprosthesis. Secondary objectives of this study include:~     investigating the value of different imaging modalities in evaluating periprosthetic~     regurgitation after TAVR and studying the difference in clinical endpoints according to~     VARC-2 definitions and quality of life after TAVR between two available aortic valve~     prostheses.~   "
121127|NCT01982019|"~     The 26RFa was recently discovered in the hypothalamus. In rodents it seems to be related to~     glucose metabolism and obesity. However, no data exists in obese patients or in patients with~     diabetes. Thus, the investigators planned to dose 26RFa level in obese patients before and~     after a sleeve gastrectomy in order to study the effect of a weight loss on its levels. The~     investigators will also dose 26RFa concentrations in obese patients with type 2 diabetes and~     in healthy volunteers with normal weight. Comparison of these different groups will permit us~     to better understand the 26RFa involvement in glucose concentration regulation and in~     obesity.~   "
121128|NCT01982006|"~     Cataract is the leading cause of blindness worldwide and cataract surgery is the most~     frequent surgery performed in France. A new technology, the femtosecond laser-assisted~     cataract surgery, has to be compared with phacoemulsification alone, the conventional~     cataract surgery, to determine the economic impact of femtosecond laser-assisted process for~     the French healthcare insurance.~   "
121129|NCT01981993|"~     BACKGROUND:~      Early diagnosis and prognostication of acute kidney injury in patients with sepsis is key to~     further our understanding this disease and in the evaluation of new interventions for this~     condition. Many urinary biomarkers have been proposed, but no single one seems to~     consistently provide additional information on top of clinical and routine biochemical~     parameters. Some authors have proposed to use a panel of urinary biomarkers to increase the~     accuracy However, this approach has so far not been tested in a large group of patients with~     sepsis. In addition, newer and more performant analytical techniques have been developed that~     warrant testing in the clinical field.~      PATIENTS AND METHODS:~      At least 150 consecutive patients admitted to a tertiary care intensive care unit (ICU) with~     sepsis will be included. After bladder catheterisation, urinary samples will be collected at~     time points 0, 4 hours and 24 hours after admission, and further daily on day 1-5. Samples~     will be immediately centrifuged and frozen at -80°C until analysis. Samples will be extracted~     by removing larger proteins (>20kDa) and de-salting step prior to mass spectrometry analysis.~     Investigators will use capillary electrophoresis-mass spectrometry (CE-MS) to assess urinary~     peptides predictive of AKI: 20 peptides constituting the AKI marker pattern previously~     established from a cohort of ICU patients. Simultaneously, samples will be analysed using~     matrix-assisted laser desorption ionisation time-of-flight mass spectrometry (MALDI-TOF MS),~     an alternative platform to CE-MS, which is currently being developed for routine ICU use. A~     proof of concept of the technique involved has been successfully applied to a set of urine~     samples from patients diagnosed with diabetes presenting normoalbuminuria (controls) and~     macroalbuminuria (cases).~      Clinical, demographic and biochemical data of patients will be collected during the first 5~     days.~      PATIENT OUTCOME~        -  in the short term:~             -  development of acute kidney injury according to RIFLE criteria~             -  death~             -  need for renal replacement therapy during ICU stay~        -  on the longer term~             -  death~             -  need for renal replacement therapy~             -  estimated glomerular filtration rate as calculated by MDRD at 3 months, 1 year and~               2 years.~      Using cut-offs , Receiver Operating Characteristics curves, negative and positive predictive~     value will be used to describe diagnostic performance of the biomarker panel alone, or in~     combination with basic clinical and/or routine biochemical parameters. Univariate and~     multivariate logistic regression for death will be used to evaluate prognostication value of~     the biomarker set.~      In addition, new discriminatory cut-offs of proteomic patterns as determined by more recent~     proteomic analysis techniques will be determined in a training set (half of the cohort) and~     validated in the other half of the cohort. Using the MALDI-TOF MS platform, investigators~     will assess urinary peptides that were predictive of AKI in a training set (ca. 75 patients)~     with good diagnostic performance of the marker panel (accuracy above 0.8) . Performance of~     the biomarker panel will be assessed in a blinded test set of ca. 75 patients to evaluate~     validity of the model in AKI detection.~   "
121356|NCT01979029|"~     To evaluate the influence to the blood supply of the anastomosis and the harvest of the No.~     253 lymph nodes in different surgical methods--- preserving the left colic artery (LCA) and~     resect the No. 253 lymph node specifically in the radical resection of rectal carcinoma or~     dividing at the root of the inferior mesenteric artery (IMA) in the radical resection of~     rectal carcinoma.~   "
121132|NCT01981954|"~     In children with a severe form of spina bifida (which is the consequence of a spinal cord~     defect) it can happen that the bladder muscle (detrusor) contracts strongly and without~     warning (neurogenic detrusor overactivity) and that the urethra (the passage connecting the~     bladder with outside) does not relax. Those children cannot void but urine leakage can happen~     when the pressure in the bladder is so high that it overcomes the closed urethra (overflow at~     high filling bladder pressure) and/or when an overactive contraction is very strong. The high~     bladder pressure before overflow occurs puts those children at risk for kidney damage and the~     overactive contractions decrease the quality of the bladder additionally to the fact that~     they can cause leakage. Therapy is aimed to decrease the high filling bladder pressure and~     the overactive detrusor contractions.~      The purpose of this study is to evaluate long term efficacy and safety of treatment with~     solifenacin succinate (the study drug) and blood levels of solifenacin succinate (the study~     drug) in children with neurogenic detrusor overactivity after multiple dose administration.~   "
121133|NCT01981941|"~     To evaluate the safety, efficacy and pharmacokinetics of gabapentin enacarbil in moderate to~     severe primary RLS patients with moderate renal impairment and to confirm dosage and~     administration in such population.~   "
121134|NCT01981928|"~     The purpose of the study is to see how safe the study drug is and how well it is tolerated~     after dosing. The study will also investigate how the study drug is taken up, metabolized~     (chemically broken down), distributed through the body and excreted. A further aim is to look~     at how this process is possibly altered by food by giving the study drug in the presence and~     absence of meals.~   "
121135|NCT01981915|"~     Patients with underlying neuromuscular disorder (NMD) often suffer from weakness in the~     inspiratory and expiratory muscles. Consequently they do not have the strength to generate~     the minimum flow of 160 to 300 liters/minute for an efficient cough function. The restricted~     cough function allows secretion to accumulate, which in turn causes narrowing of the airway~     lumen and makes ventilation of the neuromuscular patient even more difficult. The patient's~     susceptibility to infection increases again and the vicious circle repeats itself. Severe~     secretion retention may even lead to ventilator failure. Effective secretion and cough~     management instead reduces the risk for stay in hospital. Therefore, secretion and cough~     management is a mandatory part of the therapeutic concept for treating patients with~     neuromuscular disease.~      The therapeutic efficacy of the Lung Insufflation Assist Maneuver(LIA) integrated in the~     ventilator VENTIlogic LS-plus manufactured by Weinmann GmbH+Co KG was studied in a pilot~     study carried out by the Dep. for Pediatric Pulmonology and Sleep Medicine at the University~     Hospital of Essen/Germany in cooperation with Research & Development at Weinmann GmbH &Co KG,~     Germany . The objective of the pilot study was to examine the therapeutic efficacy of LIAM as~     a cough support function in patients with neuromuscular disease and indications for~     mechanical ventilation.~      We hypothesized that i) a certain insufflation maneuver pressure may be optimal to achieve~     the highest individual peak cough flow and ii) that this pressure is below the pressure~     needed to achieve the maximum insufflation capacity. We define the lowest insufflation~     capacity at which the best individual PCF can be achieved as optimum insufflation capacity~     (OIC). The study was performed using two different techniques in order to demonstrate that~     findings are not dependent on maneuver details but are rather based on effects of maneuver~     pressure. The protocol was limited to techniques which do not require breath stacking: i)~     insufflation with an Intermittend Positive Pressure (IPPB) device and ii) with the VENTIlogic~     LS using LIAM.~   "
121136|NCT01981902|"~     Dehydration can result from exposure to harsh environments including hot and dry desert~     climates. Soldiers and non-military workers are frequently required to work in hot, dry~     conditions, and dehydration can be productivity limiting and life threatening if~     unrecognized.~   "
121137|NCT01981889|"~     Steroid is commonly used to treat autoimmune disorders such as rheumatoid arthritis, lupus,~     and inflammatory bowel disease (Crohn's Disease and Ulcerative Colitis). However, its use is~     associated with numerous systemic side-effects, including diabetes, osteoporosis, and~     potentially significant mood changes. The investigators wish to determine how common patients~     with inflammatory bowel disease experience mood changes when they take steroid for their~     disease.~   "
121138|NCT01981876|"~     Esophageal squamous cell cancer (ESCC) is common in the developing world, and is the leading~     cancer diagnosis at Tenwek Hospital in southwestern Kenya. The investigators long-term goal~     is to understand the pathogenesis and risk factors for ESCC in Kenya, and to establish~     effective screening and prevention programs. The investigators hypothesize that asymptomatic~     esophageal squamous dysplasia (ESD) is common in their region, and the current protocol is~     designed to determine the prevalence of ESD in residents of southwestern Kenya.~   "
121139|NCT01981863|"~     It is common practice to use antifibrinolytic agents before and during cardiopulmonary~     bypass. They are not without side effects. The investigators want to show that there is no~     proof of fibrinolysis in standard sternotomy cardiac surgery patients before cardiopulmonary~     bypass, and that antifibrinolytic agents should only be started on cardiopulmonary bypass.~   "
121140|NCT01981850|"~     PRM-151 is an investigational drug that is being developed for possible use in the treatment~     of myelofibrosis (MF), a disease in which the bone marrow, which is the organ in the body~     that makes blood cells, is replaced by fibrosis, or excess scar tissue.~      The purpose of this study is to gather information on whether PRM-151 has an effect on the MF~     disease, whether it is safe in patients with MF, and how well it is tolerated.~   "
121141|NCT01981837|"~     The purpose of this study is to determine the pharmacokinetics, pharmacodynamics and~     exploratory clinical activity of ALN-TTRSC (revusiran) in Patients with Transthyretin (TTR)~     Cardiac Amyloidosis.~   "
121155|NCT01981655|"~     The objective of this trial to see whether:~      -Cardiac performance (cardiac index and secondary outcomes)can be improved in patients with~     acute heart failure (AHF) and symptoms and consequences of fluid overload (pulmonary and~     interstitial edema) and poor peripheral perfusion can be reduced by:~        1. Providing lactate as a substrate(Improve cardiac index)~        2. Simultaneously restoring optimal preload~      Optimal standard treatment will be achieved in both arms with the use of current best~     treatment protocol for AHF as per independent treating physician.~      4. To assess effects of 0.5M Na lactate (Totilac) on plasma and urine biological parameters~     (sodium, potassium, chloride, pH, bicarb, base excess, albumin)~      5. To assess effects of 0.5M Na lactate on morbidity and mortality.~   "
121186|NCT01981239|"~     It was well known that aspiration is the primary cause of an aspiration pneumonia among the~     dysphagia patients.~      In order to predict the degree of an aspitation,video-fluoroscopic-swallowing study and~     fiberoptic-endoscopic swallowing evaluation have been developed, but those evaluations are~     invasive and allowed only in a limited condition.~      In this study, as a precedent study for the non-linear analysis, voice analysis using LPC~     method will be evaluated. The superiority of LPC method will be compared with a spectral~     analysis using Jitter and Simmer as a positive control.~      This clinical study will be performed prospective, positive-controlled, single-blind (i.e.~     assessor-blind),and single cohort clinical trial for efficacy~   "
121142|NCT01981824|"~     One of the most challenging areas currently facing obstetricians is the detection and~     management of pregnancies in which the growth of the fetus is poor. These fetuses have not~     only increased rates of perinatal morbidity and mortality, but also have higher levels of~     morbidity extending into adult life (Linda; Murray 2010).~      In developing countries including Egypt, low birth weight is a national concern and~     emphasized in population and health policies according to the latest WHO data published in~     April 2011 low Birth Weight Deaths in Egypt reached 13,587 or 3.74% of total deaths,~     Mortality was more frequent in LBW (31.6%) than normal birth weight (NBW) infants (2.0%).~      Fetal growth restriction (FGR) is defined as fetuses whose growth velocity slows down or~     stops completely because of inadequate oxygen and nutritional supply or utilization (Linda;~     Murray 2010). Low birth weight (LBW) refers to an infant with a birth weight < 2500 g, Small~     for gestational age (SGA) birth is defined as an estimated fetal weight (EFW) less than the~     10th centile and severe SGA as an EFW less than the 3rd centile, (RCOG Green-top Guideline~     No.31, 2013).~      Ultrasound has been used as a tool for determining fetal health and a variety of sonographic~     parameters have been used to screen and diagnose IUGR including fetal biometry, fetal body~     proportions (Campbell et al., 1994), amniotic fluid volume (Owen et al., 1999), subcutaneous~     tissue thickness and estimated fetal weight (EFW) (Larciprete et al., 2005).~      IUGR is associated with changes in the body proportions as undernourished fetus directs most~     of its energy to maintain the growth of vital organs, such as the brain and heart, at the~     expense of the liver, muscle and fat and this results in decreased abdominal and thigh~     circumference measurements and hence theoretically increased HC/AC, FL/AC and FL/TC ratios~     (Colley et al., 1991).~      Fetal thigh circumference has a role to play in accurately measuring fetal weight when~     incorporated with other fetal parameters and provide a potentially straightforward method for~     assessing the deposition of muscle and fat in the growing fetus; there is a scope of using~     the FL/TC ratio in predicting IUGR (Sanyal et al., 2012).~      Fetal thigh circumference to femur length ratio (FL/TC) seems to be potential for use in~     predicting IUGR (Shripad; Varalaxmi, 2005).~   "
121143|NCT01981811|"~     The purpose of this study is to evaluate adherence to treatment with, and safety and~     tolerability of, the medical information device #1 (MIND1) system in subjects with~     Schizophrenia or Bipolar I Disorder who are currently treated with oral aripiprazole.~   "
121144|NCT01981798|"~     To investigated whether an ambulant intervention program with a behavioral therapy approach~     would exert a long-term effect on chronic unspecific back or neck pain. Specifically, the~     effect on patients with pronounced fear avoidance behavior and/or with psychosocial~     limitations was addressed.~   "
121145|NCT01981785|"~     The immune system is an intricate system comprised of specialized cells, proteins, tissues~     and organs. Proper functioning is critical to the body's ability to defend itself against~     harmful pathogens. Immunological disorders and deficiencies are defects in the immune system~     that lead to abnormal immune responses. Abnormal immune responses could be derived from~     immune deficiencies, dysregulations or hypersensitivities.~      The overall goal of this research study is to identify the mechanisms of primary immune~     deficiencies and immune disorders at the genetic, cellular and molecular level, using novel~     analytic techniques to be performed on immune cells derived from blood samples. The knowledge~     gained from the aims of this study could lead to better diagnostics and identify novel~     targets for therapeutic interventions.~   "
121146|NCT01981772|"~     The purpose of this study is to determine the clinical efficacy of a buffered 4% lidocaine~     solution for incision and drainage. Ninety patients will be examined clinically to determine~     a diagnosis of cellulitis or fluctuance. The diagnosis will be confirmed by incision and~     drainage. Patients will receive either 3.6 ml 4% lidocaine with 1:100,000 epinephrine or 3.6~     ml 4% lidocaine with 1:100,000 epinephrine buffered with 8.4% sodium bicarbonate. Patients~     will rate pain prior to and throughout the procedure.~   "
121147|NCT01981759|"~     This study is a placebo-controlled 12 week trial of DCS augmentation of once-weekly CBT~     sessions in 60 schizophrenia subjects with antipsychotic-resistant delusions. In addition to~     testing efficacy, this trial will characterize DCS effects in terms of time course and~     persistence of response and will examine DCS effects on memory consolidation and cognitive~     flexibility as possible mediators of DCS enhancement of CBT for delusions.~   "
121148|NCT01981746|"~     To investigate whether reducing the volume (30 versus 10 ml) ropivacaine injected can reduce~     the number of subjects with impaired muscle strength following adductor canal block. We~     hypothesized that adductor canal block with 10 ml 0.1% ropivacaine preserves quadriceps~     strength compared with an adductor canal block with 30 ml.~   "
121149|NCT01981733|"~     The THRIVE-1 study will examine novel methods for enhancing blood flow in the lower limb~     using electrical stimulation. Increases in lower limb blood flow improve venous return and~     thereby reduce venous stasis. Since stasis is one of the compounding factors in the~     development of deep vein thrombosis, the risk of developing thrombosis should theoretically~     be proportionally reduced. This technique may prove to be a useful tool in preventing and~     reducing the incidence of deep vein thrombosis in both medical and surgical patients together~     with passengers undertaking significant duration travel (as travel - related deep vein~     thrombosis is not exclusively related to flying).~   "
121150|NCT01981720|"~     To evaluate the ongoing safety, tolerability, and efficacy parameters of PRX-102 in adult~     Fabry patients who have successfully completed treatment with PRX-102 in studies PB-102-F01~     and PB-102-F02. Patients will be enrolled to receive PRX-102 at the dose of, 1.0 mg/kg, as an~     intravenous infusion every 2 weeks (+/- 3 days). The duration of treatment will be up to 60~     months or until PRX-102 is commercially available to the subject at the discretion of the~     Sponsor and no less than 36 months.~   "
121151|NCT01981707|"~     Until today no current diagnostic tool exists to identify an early objective response when~     patients with castration-resistant prostate cancer were treated by abiraterone acetate or~     enzalutamide. According to the Prostate Cancer Working Group, the investigators have to wait~     12 weeks before the first evaluation. To know soon that the treatment is effective will be~     decisive for the oncologist, even more in palliative situation where second effects can't be~     imposed to patients.~      In post-docetaxel, the F-choline PET-CT could be used to assess the response of this new~     therapy. Moreover, the investigators suppose that we can assess an early stage if there is an~     objective therapeutic response, at 6 weeks of treatment, in order to avoid unnecessarily and~     expansive treatment.~      The aim of this study is to assess if it is possible to determine early (6 weeks of~     treatment)if a F-choline PET-CT could predict the response to abiraterone acetate or~     enzalutamide in post-docetaxel.~   "
121152|NCT01981694|"~     This study will determine the safety and tolerability of PF-06649751 given orally to healthy~     volunteers. To determine the optimal dose for future studies, the concentration of the drug~     over time will be determined by periodic blood samples. The rate of eye blinks will be~     measured as an indicator of PF-06649751 action on the receptors of interest in the brain.~   "
121357|NCT01979016|"~     The primary objective of the study is to assess the efficacy of dupilumab, compared to~     placebo, in adult patients with moderate-to-severe atopic dermatitis.~   "
121156|NCT01981642|"~     -  Study Purpose: The purpose of this study is to evaluate the sensitivity/specificity of~          noninvasive diagnostic methods for the cardiac function that are based on data available~          from the Left Ventricular Assist Device (LVAD). These diagnostic methods will be~          compared to standard clinical diagnostic procedures both at rest and during exercise.~        -  Study Design: The study is a prospective interventional cohort study.~        -  Patient cohort: Thirty heart failure patients who had or are about to have a LVAD~          implanted.~        -  Data Collection: The acquisition of LVAD data (motor current and speed) and wristwatch~          accelerometry data concurrently to the documentation of routine clinical examinations,~          such as cardiac ultrasound, electrocardiography (ECG), cardiac catheterization, and~          exercise tests, will be performed.~   "
121157|NCT01981629|"~     Currently, bedside ultrasound (US) is performed routinely in emergency department (ED)~     patients with undifferentiated shock to help guide resuscitation. Previously, it has never~     been possible to measure cardiac output on patients in the ED. Our clinical question looks at~     whether the USCOM device gives clinically relevant information in addition to ED cardiac US~     in patients with shock.~   "
121158|NCT01981616|"~     The primary purpose of this study is to determine the rates of seroconversion to a hepatitis~     B vaccine series after a single 750 mg intravenous (IV) dose of vedolizumab or placebo.~     Secondary objectives are to determine the rates of seroconversion to an oral cholera vaccine~     series, assess change in anti-hepatitis B surface antibodies and assess the safety and~     tolerability of a single 750-mg IV dose of vedolizumab.~   "
121159|NCT01981603|"~     Primary Aim A. To disseminate and determine the impact of streamlined navigation on wait~     listing and number of transplants. The navigator will provide tailored information and~     assistance to help dialysis patients complete the tasks required at each step in the~     transplant process. In the control group, dialysis patients will continue to get usual care~     from their nephrologists and dialysis facility personnel.~      Hypothesis: Compared to control patients, intervention patients will be significantly more~     likely to be wait listed or receive a kidney transplant.~   "
121160|NCT01981590|"~     The Mapping for Transvenous Phrenic Nerve Stimulation Study (MAPS) is being conducted to~     evaluate the feasibility of transvascular stimulation of phrenic nerves via an EP catheter~     advanced into the great veins.~   "
121161|NCT01981577|"~     The purpose of this study is to investigate the segregation of the subthalamic nucleus into~     its motor and non-motor regions in patients with Parkinson's disease and healthy controls~     with the aid of ultra-high field magnetic resonance imaging.~   "
121162|NCT01981564|"~     Asthma is the number one cause of pediatric emergency department (ED) visits in young~     minority children and is responsible for high healthcare costs. The ED is often the point of~     contact for many inner city children and many families view the ED as the child's primary~     source of asthma care. This study plans to test a new model of asthma care, Asthma Express~     (AEx), that includes a follow-up asthma visit in the ED for an asthma check-up , asthma~     education, a prescription for preventive asthma medications, an appointment for the child to~     see their pediatric provider and a home visit to assist families with environmental control~     methods to prevent asthma symptoms.~   "
121163|NCT01981551|"~     Background:~        -  Desmoid tumors (also known as aggressive fibromatosis), are rare, locally invasive,~          slow-growing soft-tissue tumors. The disease can be either asymptomatic or be associated~          with severe loss of organ function and significant morbidity.~        -  Treatment with the selective small-molecule Gamma-secretase inhibitor PF-03084014 caused~          significant tumor shrinkage in patients with unresectable desmoid tumors in an early~          phase clinical trial.~        -  The Notch pathway is a key regulator of cell differentiation, proliferation and~          apoptosis; aberrant signaling via the Notch pathway is associated with carcinogenesis.~      Objectives:~        -  Primary: Determine the response rate (CR+PR) of PF-03084014 in patients with desmoid~          tumors/aggressive fibromatosis~        -  Secondary: Assess symptom measures at baseline and on study; perform genotyping for~          germline and somatic mutations in APC and CTNNB1 genes; correlate clinical response to~          therapy with genotyping data; and assess modulation of the Notch pathway by evaluating~          notch response genes in tumor biopsies at baseline and after drug administration~      Eligibility:~        -  Age greater than or equal to18; histologically confirmed desmoid tumor not amenable to~          curative resection or definitive radiation therapy that has progressed after receiving~          at least one line of standard treatment; adequate organ function~        -  Willingness to provide blood samples and 10 unstained slides or a tumor block for~          genetic research studies~      Study Design:~        -  This is an open-label Phase II trial of PF-03084014; study drug will be administered~          orally at 150 mg twice a day in 21-day cycles~        -  Optional tumor biopsies for research purposes will be performed at baseline prior to~          study treatment and at the beginning of cycle 7 (+/- one cycle)~        -  Restaging scans (MRI with diffusion weighting) will be performed at baseline, at the end~          of cycles 1 and 6, and then every 6 cycles~        -  Health-related quality of life (HRQOL)/symptom questionnaires will be administered at~          baseline and at each Clinical Center visit~   "
121164|NCT01981538|"~     Background:~      - Caring for a loved one is often stressful. Some studies show it may affect health and~     emotions. Researchers want to know more about this but do not know the best way to gather~     data. They want to know if an online survey is a good way to gather data from caregivers of~     people receiving cancer treatment at the NIH Clinical Center. They want to know if there are~     differences among caregivers depending on the type of cancer treatment the family member or~     friend is receiving. They want to use this data to improve support programs for caregivers.~      Objectives:~      - To see if an online study is a good way to get data from caregivers of people with cancer.~      Eligibility:~      - Adults 18 years old and older who are taking care of a cancer patient at the NIHCC.~      Design:~        -  The study period begins when the family member or friend begins a new cancer treatment~          and continues for 6 months afterward.~        -  Participants will complete an online survey 3-4 times. This will include questions about~          caregiving, stress, emotions, and spirituality. The survey can be taken anywhere on a~          computer. It will take about 30 45 minutes each time.~        -  Participants will also answer general questions about themselves and their health. This~          will be done over the phone with the study team. It will take 5 minutes.~   "
121183|NCT01981278|"~     The purpose of this study is to evaluate bioequivalence (scientific basis on which drugs with~     the same active ingredient(s) are compared) of a new tapentadol extended-release (ER) 250-mg~     tamper-resistant formulation (TRF) tablet to the current tapentadol ER 250-mg~     prolonged-release formulation 2 (PR2) tablet in healthy participants under fasted conditions.~   "
121187|NCT01981226|"~     Extracoporeal shock wave therapy(ESWT) was perfomed on the plantar fascia of chornic plantar~     fasciitis patients. Pre-ESWT and post-ESWT pain intensity, sonography and sonoelastrography~     of the plantar fascia was checked. Our hypothesis is that the plantar fascia stiffness~     increased after ESWT as clinical symptom improves.~   "
121358|NCT01979003|"~     To determine if Fluorescein systemic injection during hysterectomy procedure can be useful in~     revealing the depth of endometrial cancer invasion.~   "
121165|NCT01981525|"~     Background:~        -  Li Fraumeni Syndrome (LFS) is a highly penetrant, autosomal dominant cancer~          predisposition disorder. Four main cancer types including sarcoma, adrenocortical~          carcinoma, breast cancer, and malignant brain tumors commonly characterize LFS but the~          syndrome can include other cancers.~        -  Metformin is an oral biguanide drug that is approved by the FDA for the treatment of~          type II diabetes. Metformin has been associated with reduced cancer risk in several~          epidemiologic studies and reduced cancer mortality in patients with type 2 diabetes.~        -  Metformin decreases circulating insulin and IGF1, and promotes glucose uptake in~          skeletal muscle and inhibits gluconeogenesis in the liver. Elevations in circulating~          insulin and IGF1 levels have been associated with increased cancer risk.~        -  Preclinical research in animal models shows that metformin may be more toxic in cancer~          cells that have lost p53 function.~        -  Lifetime risk of cancer in LFS patients with germline TP53 mutations is estimated to be~          up to 70% by age 60, with women having excess lifetime cancer risk (up to 100%) compared~          to men (up to 80%). There are currently no approved chemopreventive agents for patients~          with LFS.~        -  Metformin has been shown to be safe and tolerable in diabetic and non-diabetics, and may~          be an ideal candidate for chemoprevention of cancer in this population.~      Objectives:~        -  Determine the tolerability of oral daily metformin in patients with LFS caused by~          germline TP53 mutations.~        -  Determine if 8 weeks of daily metformin administration has any effect on circulating~          IGF-1, insulin, and IGFBP3~      Eligibility:~        -  Must have a germline TP53 mutation and provide documentation of testing.~        -  Must have adequate organ function.~        -  Age greater than or equal to 18 years.~      Design:~        -  This is a pilot study to assess the tolerability of daily oral metformin administration~          in patients with LFS caused by germline TP53 mutations and to study the effect of~          metformin on biomarker levels in these subjects.~        -  In the absence of intolerable toxicity, a minimum of 22 patients will take metformin by~          mouth for a total of 14 weeks and then discontinue metformin for 6 weeks. The total time~          on study will be 20 weeks.~        -  Patients will be assessed for biomarker levels (IGF-1, insulin, IGFBP3) by blood sample~          at baseline, and weeks 0 and 8.~   "
121166|NCT01981499|"~     PF-05180999 is a phosphodiesterase-2 inhibitor that is hypothesized to be able to reduce~     vascular permeability. The purpose of this study is to evaluate the safety, tolerability,~     pharmacokinetics, and effects on histamine-induced wheal of single doses of PF-05180999 in~     healthy adult subjects. Histamine-induced wheals are biomarkers of vascular permeability.~   "
121167|NCT01981486|"~     PF-05180999 is a novel phosphodiesterase-2 (PDE2) inhibitor. The purpose of this study is to~     evaluate the safety, tolerability, and pharmacokinetics of multiple doses of PF-05180999~     administered twice daily over 14 days. Exploratory measures of PDE2 inhibition will also be~     evaluated in blood and blister fluid.~   "
121168|NCT01981473|"~     The purpose of this study is to examine the relationship between anti-drug antibodies, serum~     drug concentrations, and clinical response for rheumatoid arthritis patients being treated~     with etanercept, adalimumab or infliximab.~   "
121169|NCT01981460|"~     We are evaluating the effect of methylene blue and visible light activation on the microbiome~     of the skin.~   "
121170|NCT01981447|"~     The purpose of this study is to evaluate the safety of IV Lacosamide in children ages 4-35.~   "
121171|NCT01981434|"~     Technology-Based Obesity Prevention Project (TeBOPP) is a bilingual (English/Spanish)~     family-based educational intervention that will use a novel videogame format to educate~     underserved inner city Latino children and adolescent patients and their parents about~     healthy diet and exercise. To the best of our knowledge this is the first family focused~     obesity prevention educational intervention using a gaming scenario where both parents and~     children/teens (8-15 years) participate simultaneously. The goals are to improve parent-child~     (teen) knowledge regarding healthy food habits and create a change in attitude towards~     healthy eating and exercise.~      Hypothesis: We hypothesize that game-based avatars (i.e., a graphical representation of an~     individual within a virtual space) can create change in knowledge and attitude towards~     healthy eating and exercise.~   "
121172|NCT01981421|"~     Liver fibrosis has been considered as irreversible change. However, recent study showed that~     early stage liver fibrosis could be reversible and a lot of new drugs are now developing or~     developed including anti-viral treatment. Liver biopsy is considered as golden standard for~     the evaluation of liver fibrosis. But biopsy specimen through biopsy only consists of 1/50000~     of the whole liver and heterogeneity of liver fibrosis, accurate diagnosis of liver fibrosis~     is still challenging. Furthermore, its invasive nature, repeated biopsy is practically almost~     impossible. Hence, non-invasive diagnosis of liver fibrosis is important. In this study we~     hypothesized that multi-parametric MR imaging including MR elastography, conventional DWI,~     and IVIM can predict changes of liver stiffness after anti-viral therapy in patients with~     chronic liver disease. We will enroll 60 biopsy-proven patients and perform multi-parametric~     MR imaging at the enrollment and one year later to evaluate changes in quantitative values in~     MR.~   "
121173|NCT01981408|"~     This type of study is called a radiolabeled study. For this study, LY2801653 (study drug) has~     been specially prepared to contain radiolabeled carbon [^14C]. [^14C] is a naturally~     occurring radioactive form of the element, carbon. This study will increase understanding~     about how the drug appears in the blood, urine, and stool after it is administered to healthy~     people. Information about any side effects that may occur will also be collected. This study~     will last up to 15 days for each participant, not including screening. Screening is required~     within 28 days prior to enrollment.~   "
121174|NCT01981395|"~     Our goal is to demonstrate that healthy volunteers treated with fenobam will develop a~     significantly reduced area of cutaneous hyperalgesia compared to volunteers treated with~     placebo, after exposure to the heat/capsaicin model of cutaneous sensitization. Additionally~     we are going to assess changes in mood/affect and cognitive function of subjects following~     administration of fenobam and after cutaneous sensitization compared to baseline.~   "
121175|NCT01981382|"~     This research study will examine whether enhanced pain sensitivity increases the risk of~     persistent low back pain. The study will address the highly prevalent and costly condition of~     persistent low back pain and a major obstacle for the implementation of clinical strategies~     to improve patient outcomes. The knowledge gained from this study may lead to a better~     understanding of the biological mechanisms that contribute to persistent low back pain and~     will inform future work to develop predictive measures of persistent low back pain risk,~     evaluative measures to examine treatment efficacy, and possibly biomarker assay(s) to~     identify patients who are at increased risk of persistent low back pain.~   "
121184|NCT01981265|"~     This is a case-control study involving one medical center and one research institute to~     develop a data-set containing a minimum of 100 osteoarthritis cases, minimum of 100~     independent controls of similar gender ratio and a minimum of 100 disease controls (cases~     with hip and/or knee OA) to associate DNA sequence (allelic) variations in candidate genes~     with osteoarthritis phenotypes.~      This study is intended to begin at the Institute of Biomedical Sciences at Academia Sinica~     (which includes National Genotyping Center (NGC) and National Clinical Core (NCC)), National~     Taiwan University Hospital.~   "
121176|NCT01981369|"~     The study will evaluate the effect of Dexmedetomidine sedation on the duration of~     infraclavicular block in patients scheduled for surgery of elbow, forearm and/or hand. All~     patients will receive infraclavicular block before the surgery and then they will be~     randomized to receive either Dexmedetomidine or Propofol sedation. Duration of the sensory~     block will be evaluated in recovery room, 24 and 48 hours after the surgery.~      Hypothesis:~      Primary: Dexmedetomidine sedation increases the duration of sensory infraclavicular block in~     patients scheduled for upper limb surgery.~      Secondary: Dexmedetomidine sedation~        -  Gives an adequate level of sedation during the surgical procedure~        -  Reduces the requirements of postoperative opioids~        -  Improves the quality of sleep on the night of the surgery~        -  Increases patients satisfaction regarding the anesthesia technique~        -  Dexmedetomidine sedation is safe and easy to use~        -  Dexmedetomidine sedation provides less respiratory depression during the procedure.~   "
121177|NCT01981356|"~     There is a substantial need for enhancing the efficacy and effectiveness of Veterans Health~     Administration (VHA) inpatient services for psychosis and tailoring them to support recovery.~     The proposed pilot study will explore whether Acceptance and Commitment Therapy (ACT), a~     recovery-oriented, evidence-based inpatient treatment, is a feasible, acceptable, safe, and~     effective adjunct for the inpatient treatment of Veterans with psychosis at a single VHA~     site. Additionally, an evaluation of barriers and facilitators to future implementation will~     be conducted. If promising, the data gained from the proposed study will support future~     evaluation, implementation and dissemination efforts that have the potential to improve~     inpatient treatment for psychosis and recovery, and thus, the lives of Veterans, while~     reducing costs for VHA.~   "
121178|NCT01981343|"~     Gallstone formation is multifactorial: immutable risk factors include genetics and ethnicity,~     age and being female, and mutable risk factors include obesity, and metabolic syndrome, diet,~     rapid weight loss, and other conditions such as cirrhosis, Crohn's disease, irritable bowel~     syndrome, gallbladder stasis, and the use of certain drugs like Ceftriazone. Previous studies~     have linked serum cholesterol, and low-density lipoprotein cholesterol levels and fatty liver~     disease to gallbladder disease. Given betaine's reported beneficial effects on fatty liver~     and lipid profile, A-F Betafood® may have a beneficial effect on gallbladder function.~      The objective of the study is to assess the effect of A-F Betafood® on gallbladder and liver~     function as measured by gallbladder ultrasounds and liver function tests. The hypothesis is~     that A-F Betafood® will improve gallbladder and liver function after the 12 week treatment~     period.~      This is a single-center, randomized, double-blind, placebo-controlled, parallel group study~     with two arms. This study will consist of a single 12 week treatment period. The planned~     sample size for this study is 50 overweight female subjects, with 25 subjects randomized~     equally to each of the two study arms in double-blind manner at a ratio of 1:1~   "
121179|NCT01981330|"~     This is a pilot-study of 16 selected Swedish patients which all have severe hoarseness or~     aphonia due to vocal fold scarring (from previous surgery, radiation therapy, inflammation or~     possibly hereditary). The patients are operated with phonomicrosurgical dissection of the~     scarred vocal folds, removal or scar tissue and injection of autologous mesenchymal stroma~     cells, aMSC (which were previously harvested from each patients´s bone marrow, purified,~     expanded and characterized according to standard procedure at the Center of Hematology and~     Regenerative Medicine Karolinska University Hospital Huddinge). 8 Patients is planned to be~     treated with a single injection of aMSC and 8 patients with injection of aMSC mixed with a~     carrier hyaluronan gel developed at Uppsala University Sweden and at the Karolinska~     Institute. The laryngeal status, vocal fold function, and voice function will be followed~     individually with an advanced battery of examinations performed before and up to 1 year~     postoperatively. Side effects and complications are noted and reported during surgery and~     following surgery at regular intervals during at least 1 year Since spring 2015 no new~     patients have been recruited and no treatments are given during 2016 or 2017. The monitoring~     authority was changed from Swedish National Board of Health to Swedish Medical Product Agency~     (MPA) in March/April 2016. Further inclusions and treatments are postponed until permission~     is granted from MPA to continue the study.~   "
121180|NCT01981317|"~     The purpose of this research study is to determine how well children with OCD can be helped~     using therapy that requires less clinic visits. The investigators are testing a Stepped-Care~     Cognitive Behavioral Therapy (SC-CBT) approach in which children receive a full course of~     parent-led, therapist-guided treatment for OCD. The goal is to see if therapy can be done in~     fewer visits to the clinic. Children receiving SC-CBT will start with Step One, which~     includes three therapy sessions over six weeks. Those who do not get better in Step One will~     STEP UP to Step Two which involves coming in to meet with a therapist for the remaining~     sessions. Youth receiving SC-CBT will be compared to youth receiving standard CBT in the~     clinic through this study. It is expected that Stepped Care will be an acceptable,~     cost-effect, and feasible treatment with outcomes similar to standard CBT.~   "
121181|NCT01981304|"~     Percutaneous coronary intervention with stenting may induce endothelial damage/dysfunction~     and inflammatory reactions, which in turn delay healing and endothelialization and may lead~     to the occurrence of major adverse cardiac events (MACE), such as restenosis,~     atherosclerosis, and stent thrombosis.~      Drugs, platforms and polymers are considered the protagonists of these pathophysiologic~     processes.~      The objectives of the INERT study is to assess the extent of inflammation and endothelial~     damage induced by the first carbonized bio-absorbable coated rapamycin-eluting coronary stent~     at time of percutaneous coronary intervention and correlate the extent of these abnormalities~     with short and long-term clinical outcome and post-procedural evaluation of success.~      As part of the study, a randomized sub-study will be carried out at the Coordinating Center~     in order to compare the biohumoral, clinical and procedural findings between patients with~     the carbonized bio-absorbable coated rapamycin-eluting coronary stent and those randomly~     assigned to receive stents with different platforms and polymers.~   "
121182|NCT01981291|"~     This study was designed to assess whether the injection of local anesthetic into the nerve~     (intraneural), as opposed to around it (perineural), leads to longer anesthesia and analgesia~     of the leg.~      Some reports of accidental intraneural injection mention an extremely long duration. When~     different drugs and doses were evaluated in a clinical trial of intraneural injection, a~     longer-than-expected duration was reported.~      The investigators will compare the two types of injection using the same drug, so as to~     determine if there is an actual difference in duration.~   "
121188|NCT01981213|"~     A: Early predictors of hepatic injury after suicide attempt with acetaminophen:~      To explore the following in a pediatric population with acetaminophen overdose due to suicide~     attempt: 1) the prevalence of episodes of pre- and in-hospital vomiting and the relationship~     between the total number of vomiting episodes and hepatic injury, 2) the relevance of the~     early initiation of N-acetylcysteine (NAC) treatment to hepatic injury, and 3) the~     presence/absence of illness prior to the suicide attempt and hepatic injury.~      B: Characteristics, social behaviour, trends and risk factors:~      1. To explore the relationship between children admitted to a paediatric department as a~     result of suicide attempts with acetaminophen and their parents and friends. 2. To determine~     the extent to which the children had attempted to speak to their parents or other adults~     about their problems before their suicide attempts. 3. To determine the prevalence of~     self-mutilation among children with suicidal behaviour. 4. To examine the reasons for these~     suicide attempts.~      C: Establishment of the expression of cytochrome P450 in a pediatric including the~     age-adjusted activities.~      Urine samples will be analyzed using an HPLC tandem mass spectrometric method, which we have~     already established in our lab.~      There will be categorized three groups for comparison:~        1. An age-appropriate background population (approximately 200 patients)~        2. Paediatric patients that have been admitted to Rigshospitalet, due to severe hepatic~          injury (approximately 50 patients)~        3. Other pediatric patients admitted to their local hospital because of acetaminophen~          poisoning (approximately 200 patients) A control urine sample will be analyzed three~          months after the suicide attempt.~   "
121189|NCT01981200|"~     To examine the feasibility of progressive unilateral knee-extension strength training using~     ankle weight cuffs in patients hospitalized due to acute exacerbation in COPD~   "
121190|NCT01981187|"~     The purpose of this signal seeking study is to determine whether treatment with LGX818~     demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic~     malignancies to warrant further study~   "
121191|NCT01981174|"~     The purpose of this study is to compare the levels of pain resulting from injections of~     Botox® for wrinkles on the forehead and between the eyes using two different sized needles~     (32 gauge and 30 gauge needles).~   "
121192|NCT01981161|"~     Under the escalation treatment strategy when a patient displays breakthrough disease~     parameters under first line therapy, MS physicians are allowed by the EMEA to switch for~     Natalizumab (NTZ) or fingolimod (FGL). NTZ and FGL efficacy have been demonstrated by~     randomized therapeutic trial. As both treatments have been tested versus placebo a common way~     to compare them is to look at their respective annualized relapse risk ratio decrease.~     Roughly NTZ decrease by 70% and FGL by 50%. Nevertheless it is a terrible comparison since~     the placebo group had different behaviour in the 2 trials and the patients demographic~     features at baseline are also different. Therefore, it is right now totally impossible to~     compare these 2 drugs with a decent methodology. Only a head-to-head comparison could do it.~     Unfortunately this head-to-head comparison is not available and will not probably be done~     under the drug companies initiative. During the time of this study, we will perform a phase~     IV, observational, prospective head-to-head comparison of NTZ versus FGL efficacy in 600~     patients. Our primary end point will be disease free patients after 1 year of treatment.~     Further, this trial will allow us to collect new biological samples, useful for a validation~     our project main aim. Further these new samples will be obtained from 3 European countries,~     which is a must if we want to generalize our conclusion obtained from a French cohort.~     Cooperation at the European level is thus essential for the implementation of this project .~   "
121193|NCT01981148|"~     Fluorescent lifetime microscopy has emerged as a useful tool to study fluorescent lifetimes~     in vitro. Fluorescence lifetime represents the average amount of time a fluorophore remains~     in the excited state following excitation and depends on the fluorophores molecular~     environment. Fluorescence lifetime ophthalmoscopy (FLIO) is a technique which can quantify~     fluorescence lifetimes in the human retina in vivo. The purpose of this study is to~     investigate fluorescence lifetime characteristics in the human retina by using a FLIO. The~     investigators hypothesize that FLIO will allow to identify areas of retinal metabolic stress~     such as ischemia by detecting changes in fluorescence lifetimes.~   "
121194|NCT01981135|"~     Purpose: The purpose of this protocol is to understand how individuals respond to the air~     pollutant ozone at elevated temperatures. Ultimately, this will help us understand what the~     risks from poor air quality are during a heat wave.~      Participants: We will recruit up to 30 healthy adults, 18-55 years old, to participate in~     this study.~      Procedures (methods): Subjects will be exposed to clean air and to 0.3 ppm of ozone for 2~     hours with intermittent exercise in a controlled environment chamber. For each exposure the~     temperature in the chamber will be between 31-34oC (88-93 oF). Because the aim of the study~     is to mimic high exposure during a heat wave, we will perform exposures only on days when~     mean ambient temperatures was less than 24 oC in Chapel Hill on the previous day.~      Primary endpoints will include spirometry and Heart Rate Variability monitoring. Secondary~     endpoints will include analysis of blood clotting/coagulation factors, and analysis of~     soluble factors present in plasma.~   "
121195|NCT01981122|"~     This is a randomized, open-label study designed to assess the effects of sipuleucel-T when~     administered concurrently or sequentially with enzalutamide.~   "
121196|NCT01981109|"~     The primary purpose of this research is to describe patient characteristics predictive of an~     imaging study positive for distant metastases in patients with castration-resistant prostate~     cancer and no known distant metastases.~   "
121197|NCT01981096|"~     The purpose of this pilot randomized trial is to determine whether the fibromyalgia~     integrative training (FIT Teens) intervention is superior to cognitive-behavioral therapy~     (CBT) alone in reducing pain among adolescents with juvenile fibromyalgia (JFM).~      Hypothesis 1: Patients in the FIT Teens group will show significantly greater reduction in~     pain intensity than the CBT group at final study assessment (i.e., 3-month follow up).~      Hypothesis 2: Patients in both the FIT Teens and CBT groups will show significant reductions~     in functional disability and depressive symptoms at final study assessment (i.e., 3-month~     follow up).~   "
121230|NCT01980667|"~     Clinical and Pharmacokinetic Study of Lurbinectedin (PM01183) in Combination with Cisplatin~     in Patients with Advanced Solid Tumors to determine the recommended dose (RD) of PM01183 in~     combination with cisplatin, to characterize the safety profile, the pharmacokinetics (PK) of~     this combination, to obtain preliminary information on the clinical antitumor activity and to~     conduct an exploratory pharmacogenomic (PGx) analysis.~   "
121198|NCT01981083|"~     Malnutrition is seen frequently in hemodialysis units in most developing countries.~     Malnutrition increases morbidity and mortality in this population and its treatment improves~     patient survival and health status The purpose of this study is to compare two strategies to~     improve nutritional status in hemodialysis patients: renal-specific oral supplement (237 ml)~     versus egg albumin-based protein supplement (30 g) on a daily basis.~      This trial uses the Malnutrition Inflammation Score (MIS) and Subjective Global Assessment~     (SGA) in addition to most used biochemical markers to determine nutritional status.~   "
121199|NCT01981070|"~     The purpose of this study is to evaluate the impact of two community based interventions for~     parents of adults with intellectual or developmental disabilities (IDD) who are requesting~     services.~      The two interventions will include:~        1. Support and Information Intervention - provides parents with support and information~          about services for their sons and daughters~        2. Mindfulness Intervention - empowers parents through teaching them mindfulness skills~      We hypothesize that:~        1. Parents in both types of interventions will report benefits (reductions in psychological~          distress) maintained at follow-up.~        2. Parents in mindfulness intervention group will report improvements in mindful parenting,~          self compassion, positive gain, empowerment, and reduced burden. Parents in support and~          information intervention group will report improvements in empowerment, positive gain,~          and reduced burden.~        3. Parents in mindfulness intervention group will show greater improvements by 3 months~          follow-up than parents in the support and information group.~   "
121200|NCT01981057|"~     The aim of this prospective noninterventional study is to evaluate the clinical application~     of Numeta® in preterm infants and critically ill neonates in comparison to individualized~     prescribed parenteral nutrition. With the prescription software Cato-PAN® (by Cato software~     solutions) exact valid prescriptions for ordering parenteral nutrition solutions for~     premature infants are compared. Each PN solution is prescribed individually as well as with~     Numeta. Prescriptions were mirrored with respect to weight, venous approach, total volume and~     amount of enteral feeding, 24h medication and flipped vice versa. The key nutrient for~     calculating Numeta prescriptions was protein. The results of PN prescriptions were compared~     with each other/ESPGHAN recommendations. The investigators hypothesize that nutrimental~     content of Numeta prescriptions is equal to individually prescribed .parenteral nutrition~     solutions~   "
121201|NCT01981044|"~     Prospective, multi center, single arm, clinical study to obtain clinical experience with the~     use of SERI® Surgical Scaffold for soft tissue support in ventral hernia repair.~   "
121202|NCT01981031|"~     BioChaperone Combo is a liquid formulation containing both Insulin Glargine and Insulin~     Lispro.~      The aim of this trial is to assess the efficacy and safety of BioChaperone® Combo in subjects~     with type 1 diabetes under a dose of 0.8 U/kg.~      This trial is a phase 1 single-center, randomized, double-blinded, two-treatment, two-period~     cross-over, 30-hour euglycaemic glucose clamp trial in subjects with type 1 diabetes~     mellitus. Each subject will be randomly allocated to one single dose of 0.8 U/kg of~     BioChaperone® Combo and to one single dose of 0.8 U/kg of Humalog® Mix 25 on two separate~     dosing visits.~   "
121203|NCT01981018|"~     Bipolar Disorder (BD) (previously known as manic depression) is a severe mental health~     illness affecting at least 1% of the population and with annual NHS cost estimated at £342~     million. It is characterised by alternating episodes of acute mood swings: depression and~     mania (mood elation). BD also comes with less severe mood swings we call mood~     instability, and ongoing high levels of anxiety that impair well-being even during periods~     between the acute mood breakdowns. Anxiety and mood instability are associated with worse~     outcome of the disorder.~      All these symptoms can be accompanied by the presence of troublesome mental images (e.g.~     seeing a memory in the mind's eye) such as intrusive flashbacks of negative past events.~     Recent studies suggest that individuals with BD experience more vivid, compelling and~     upsetting mental images compared to other patient groups and this could contribute to their~     clinical difficulties.~      Cognitive Behavioural Therapy (CBT) is a well established and successful psychological~     therapy used in the National Health Service (NHS), UK but as yet with limited efficacy in BD.~     Targeting mental imagery has long been part of general CBT. In particular, imagery-based~     treatment techniques have proved successful in anxiety disorders, but have not been brought~     to CBT for Bipolar Disorder yet.~      Our study Mood Action Psychology Programme (MAPP) investigates the delivery of a brief~     imagery-focused cognitive therapy (imCT) intervention to people with BD, studying a series of~     patients in detail one by one a case series). We offer a structured and individualised~     psychological treatment in line with the aims of NHS guidelines. The imCT protocol has been~     successfully delivered and audited in our psychological service in Oxford (OxMAPP). The~     proposed MAPP study aims to formally assess for the first time the effectiveness of imCT. In~     particular we hypothesise that imCT via the Mood Action Psychology Programme (MAPP) will~     result in (i) reduced levels of anxiety and (ii) reduced levels of low mood after treatment~     compared to baseline (both measured over 4 weeks) in individuals with BD.~      Overall, this works aims to contribute to improved psychological treatment for BD.~   "
121204|NCT01981005|"~     This non-randomized, single group, open-label study will investigate the mass balance, routes~     of elimination, pharmacokinetics, and metabolism of a single oral dose of RO5424802 and the~     pharmacokinetics of a 14C-labeled tracer in healthy volunteers~   "
121205|NCT01980992|"~     This study is being done to learn about the medical effects, the safety, and the immunologic~     effects of Wheat Oral Immunotherapy (OIT) treatment. The goal of the study is to find out~     whether subjects can develop the ability to eat wheat (the food allergen) regularly without~     allergic symptoms after stopping the study treatment.~   "
121206|NCT01980979|"~     The purpose of this study is to evaluate the efficacy of Remodulin in the treatment of adult~     patients with congenital heart disease and pulmonary hypertension. Baseline and~     post-treatment cardiopulmonary exercise tests will be performed.~   "
121207|NCT01980966|"~     This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety~     of MHAA4549A in healthy volunteers in an influenza challenge model. Subjects will be~     intranasally oculated with the challenge virus and will be randomly assigned to receive a~     intravenous dose of either MHAA4549A or placebo. In the stage 5 cohort, subjects will be~     randomly assigned to receive doses of MHAA4549A or placebo or Tamiflu (oseltamivir) orally~     twice daily for 5 days. All subjects in all cohorts may take Tamiflu twice daily from Day 7~     to Day 11.~   "
121208|NCT01980953|"~     This 4-part study will assess the effect of formulation, food, and active pharmaceutical~     ingredient (API) lot on the pharmacokinetics of GDC-0032 in healthy volunteers. Part 1 is an~     open-label, 3-period, 6-sequence study, and Parts 2, 3, and 4 are open-label 2-period~     crossover studies. Participants will receive single doses of GDC-0032 capsule or tablet~     formulation, in the fasted or fed state.~   "
121231|NCT01980654|"~     This is an open-label, Phase 2 study designed to assess the efficacy and safety of ibrutinib~     combined with rituximab in previously untreated subjects with FL.~   "
121209|NCT01980940|"~     Study Part 1 is designed to assess the plasma pharmacokinetics of etoricoxib (ETOR) 4%~     dimethyl sulfoxide (DMSO) and propylene glycol (PG) formulations, each at 2 different doses,~     upon single-dose topical administration on the knee of osteoarthritis participants. Study~     Part 2 is designed to evaluate the efficacy of topical etoricoxib vs. placebo in the~     treatment of osteoarthritis of the knee. The primary hypothesis is that topical etoricoxib~     will be more effective than placebo in the treatment of osteoarthritis of the knee over 2~     weeks of treatment as assessed by time-weighted average change from baseline on the Western~     Ontario and McMaster Universities Arthritis Index (WOMAC) Visual Analogue (VA) 3.0 pain~     subscale.~   "
121210|NCT01980927|"~     A small number of chiropractors, who align only the atlas C-1, or top vertebra in the~     spine, practice the National Upper Cervical Chiropractic Association (NUCCA) atlas correction~     procedure. This procedure uses a precise, non-invasive, gentle touch technique to correct~     misalignment of the atlas. Although NUCCA practitioners have long used this procedure in the~     treatment of headache, it has not been formally studied using clinical trials. There is some~     data indicating that NUCCA correction can increase intracranial compliance. This intracranial~     compliance can be measured by a magnetic resonance imaging (MRI) study before and then after~     a NUCCA procedure. In this study, the investigators hope to show that the correction of an~     atlas misalignment will increase intracranial compliance in subjects with migraine.~   "
121211|NCT01980914|"~     The risk of hypoglycemia (low blood sugar) associated with the treatment of diabetes~     increases with age. Hypoglycemia is a common reason for admission to hospital for older~     patients with diabetes. Older patients are often unaware that their blood sugar is low and~     asymptomatic hypoglycemia, as assessed by continuous blood sugar monitoring, is frequent in~     the elderly. There is also evidence that older people with diabetes are more likely to~     develop cardiovascular events such a heart attack and more likely to die suddenly when~     compared to older people without diabetes. It is possible that low blood sugar levels~     contribute to the increased frequency of these events, but this possibility has never been~     studied. The purpose of this study is to assess how frequently low blood sugar occurs in~     older patients with diabetes and to see if low blood sugars adversely affect heart function~     in these patients.~   "
121212|NCT01980901|"~     The Post-Approval Study (PAS) will evaluate the real world data on the Ovation™/Ovation~     Prime™ Abdominal Stent Graft System along with the long-term data collected from the IDE~     cohort to monitor the long-term safety and effectiveness of the device.~   "
121213|NCT01980888|"~     The primary objective of this study is to evaluate the progression-free survival in~     participants with previously untreated chronic lymphocytic leukemia (CLL) who would otherwise~     be suitable for bendamustine and rituximab treatment as standard of care.~      An increased rate of deaths and serious adverse events (SAEs) among participants with~     front-line CLL and early-line indolent non-Hodgkin lymphoma (iNHL) treated with idelalisib in~     combination with standard therapies was observed by the independent data monitoring committee~     (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data~     and terminated this study in agreement with the DMC recommendation and in consultation with~     the US Food and Drug Administration (FDA).~   "
121214|NCT01980875|"~     The primary objective of this study is to evaluate the effects of idelalisib with~     obinutuzumab versus the combination of chlorambucil and obinutuzumab on progression-free~     survival (PFS) in participants with previously untreated chronic lymphocytic leukemia (CLL).~      An increased rate of deaths and serious adverse events (SAEs) among participants with~     front-line CLL and early-line indolent non-Hodgkin lymphoma (iNHL) treated with idelalisib in~     combination with standard therapies was observed by the independent data monitoring committee~     (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data~     and terminated those studies in agreement with the DMC recommendation and in consultation~     with the US Food and Drug Administration (FDA). All front-line studies of idelalisib,~     including this study, were also terminated.~   "
121215|NCT01980862|"~     Single-site blood collection investigation.~   "
121216|NCT01980849|"~     To compare the efficacy and safety of prophylaxis of venous thromboembolism by Nadroparin~     during hospitalization to long-term usage in patients with advanced lung cancer treated by~     chemotherapy and/or radiotherapy.~   "
121217|NCT01980836|"~     Patients with rheumatoid arthritis (RA) are prone to respiratory infections and therefore~     recommmended to receive vaccination against seasonal influenza. We and others have shown a~     relatively preserved humoral response to vaccination in RA patients. However, the cellular~     response as well as the effect of biologics such as tocilizumab on the cellular response has~     not been weel studied. The purpose of this study is the evaluate the effect of tocilizumab on~     the cellular immune response to influenza vaccine in patients with RA in comparison with~     healthy controls~   "
121218|NCT01980823|"~     The purpose of this study is to determine the effects of combining metformin and atorvastatin~     treatment in patients with newly diagnosed breast cancer during the interval between breast~     biopsy and surgery.~      This study is designed to assess whether tumor proliferation, as measured by the natural log~     expression of Ki-67 staining of breast tumor cells, is reduced following approximately 2~     weeks of treatment with the combination of metformin plus atorvastatin in patients with newly~     diagnosed breast cancer.~   "
121219|NCT01980810|"~     The purpose of this study is to determine whether albumine-bounded paclitaxel plus S-1 are~     effective in the treatment of advanced gastric or gastroesophageal junction adenocarcinoma.~   "
121228|NCT01980693|"~     Skeletal maturity assessment, defined also as bone age (BA), has an important role in~     pediatrics and pediatric endocrinology, used mainly for evaluating growth and puberty related~     endocrine disorders. Repeated BA assessment is important during the follow up of children~     with short stature, with precocious puberty and those treated by growth promoting~     medications.~      The most commonly used method used for determining skeletal maturity, and thus BA is based on~     comparison of a hand and wrist radiographs to a standard series of representative films in~     the Radiographic atlas of skeletal development of the hand and wrist by Greulich and Pyle~     (GP), which has been issued several decades ago. The suggested method in this study is based~     on ultrasound technology, and therefore it is quick, objective, and radiation-free. It~     delivers an immediate non biased result without the need to rely on an observer's evaluation~     of the hand radiograph and without the need for a specialized radiology facility.~   "
121220|NCT01980797|"~     Bicuspid aortic valve (BAV) disease is the most frequent congenital cardiac malformation,~     occurring in 0.5-1.2% of the US population. In young adults, it is generally a benign~     abnormality; but in older adults it is associated with thoracic aortic aneurysm or dissection~     in 20-30% of those with BAV. BAV is strongly associated with early development of aortic~     valve calcification or incompetence in >50% of BAV patients, and accounts for ~40% of the~     >30,000 aortic valve replacements (AVR) performed in the US each year. Yet, we know little of~     the etiology, cellular events and modifiers of progression of BAV to calcific aortic valve~     disease and we still do not understand the genetic cause(s) of BAV despite evidence for its~     high heritability.~      The Specific Aims of this study are:~        1. To identify the genetic causes of bicuspid aortic valve disease and its associated~          thoracic aortic disease.~        2. To identify potential pathways to predict the clinical course of BAV disease and for~          treating human BAV disease.~      To achieve these aims, we have created the International Bicuspid Aortic Valve Consortium~     (BAVCon), a consortium of institutions with cohorts of BAV patients and the expertise to~     fulfill the performance of these aims.~   "
121221|NCT01980784|"~     Severe trauma induces massive metabolic changes that are characterized by hypermetabolism~     with increased energy expenditure and catabolism. Early enteral and, if necessary, parenteral~     feeding is a major focus of modern intensive care medicine.~      After acute spinal cord injury, denervation of skeletal muscle leads to a massive loss of~     muscle mass in the area below the level of injury. This dramatic muscle atrophy again leads~     to a decrease in energy expenditure. Whereas other survivors of severe trauma typically~     regain muscle mass during rehabilitation, spinal cord injury patients typically continue to~     lose muscle mass over time, which also leads to changes in body composition. The time course~     of these changes is not known. Continuing nutrition without adaption to the reduced energy~     expenditure leads to weight gain and adiposity, exposing many chronic spinal cord injury~     patients to the known unfavorable metabolic consequences. Knowledge of the time course of~     these changes would help to provide adequate caloric intake to the patients and improve our~     ability for nutrition counseling.~      The investigators plan a prospective clinical trial in 25 acute spinal cord injury patients~     to determine the changes in energy expenditure and body composition. Major inclusion criteria~     are acute traumatic spinal cord injury, age 18-70, neurological level above L1, AIS (American~     Spinal Injury Association Impairment Scale) A, B or C.~      Measurements of energy expenditure, body composition and nutritional markers in venous blood~     are scheduled 2, 6, 10 and 14 weeks after spinal cord injury and at the end of rehabilitation~     (at the latest after 26 weeks).~   "
121222|NCT01980771|"~     This program utilizes a community-engaged research approach to implementing and evaluating a~     program that seeks to reduce sexual risk behavior among Black adult heterosexual men. The~     investigators aims are to assess the impact of this linguistically and culturally tailored~     HIV prevention program on the sexual risk of heterosexual, African American men aged 18 and~     older, to assess the intervention's impact on the more proximal social and psychosocial~     variables that the program is designed to change, and to identify key contextual level~     factors that may impact the intervention's impact across segments of this priority~     population.~   "
121223|NCT01980758|"~     The proposed study aims to investigate the effects of laparoscopic gastric plication (LGP) on~     excess body weight, body mass index, and weight-related medical and psychological~     co-morbidities in obese adolescents. Additionally, we will evaluate the safety and efficacy~     of this procedure (implemented within a multidisciplinary comprehensive lifestyle~     modification program) on changes in the patients' medical status, psychosocial and~     psychological functioning, physical fitness, and health-related quality of life.~      Study hypothesis:~        1. Laparoscopic gastric plication performed on carefully selected obese adolescents within~          a multidisciplinary treatment program providing pre and post-surgical behavioral and~          psychological support and education will result in: a) initial and sustained reductions~          in excess body weight and body mass index, b) improvements in psychological functioning,~          physical fitness, and health-related quality of life, and c) reduction in weight-related~          comorbidities.~        2. LGP will be a safe procedure, with complication rates that are comparable to or lower~          than what has been found in other published reports of surgical weight loss procedures~          used in obese adolescents.~   "
121224|NCT01980745|"~     Autoimmune hepatitis is an autoimmune chronic liver disease whose treatment includes the use~     of immunosuppressive drugs, particularly azathioprine, and corticosteroids. When properly~     treated, patients have a good survival. One of the major problems related to its treatment is~     the the high rate of relapses after stopping therapy that has lead to biochemical and~     histological remissions, close to 80%. Many authors recommend continuous treatment throughout~     life, resulting in the occurrence of many side effects. Chloroquine is a drug with~     anti-inflammatory properties already used in the treatment of other extrahepatic autoimmune~     liver diseases. There are some reports in the literature about its beneficial use in liver~     diseases such as chronic hepatitis B, and a pilot study in patients with autoimmune~     hepatitis, in which its use was associated with a 6.49 times lower risk of disease recurrence~     when compared with patients in whom treatment was discontinued after remission. Our purpose~     is to investigate, in a double-blind randomized trial with placebo, whether chloroquine~     prevents the recurrence of AIH in patients with histological remission after discontinuation~     of conventional treatment and to evaluate the occurrence of side effects.~   "
121225|NCT01980732|"~     The primary objective of the study is to evaluate 68Ga-DOTA TATE PET/CT for staging and~     monitoring response to chemotherapy in patients with carcinoid, neuroendocrine tumors,~     medullary thyroid cancer and other cancers expressing somatostatin receptors.~   "
121226|NCT01980719|"~     The purpose of this study is to determine if inflammatory markers in blood as well as brain~     neurotransmitters (markers of in-brain activity and metabolism) are related to long-term or~     chronic fatigue.~   "
121227|NCT01980706|"~     The proposed study will carefully test the hypothesis that a robust dose of baclofen (90~     mg/day) has efficacy and is safe in individuals with alcohol dependence. Furthermore, the~     proposal will test whether an indicator of physical dependence, i.e. drinks/drinking day,~     predicts response to baclofen. Additionally, the proposal will examine the anti-anxiety~     effects of baclofen within an alcohol dependent population and ascertain whether baseline~     levels of anxiety predict response to baclofen.~   "
121232|NCT01980641|"~     Background. Cognitive, communication and physical weakness combined with environmental~     changes frequently cause changes in roles, routines and daily occupations. The educational~     intervention combines the best choice for teaching new behaviours since it involves the~     active participation of the patient in learning.~      Methods. Design. Randomized clinical trial. Participants. Total sample: 80 adults who have~     suffered a stroke with moderate severity and who have been discharged to their homes.Outcome~     variables. BI, FIM, MMSE, CNS, SIS-16, TCT, MRS, MSPSS, QLSF, FRT, RT, TUG, TST, a portable~     dynamometer and a sociodemographic questionnaire. Data analysis. Descriptive analyses will~     include mean and 95% CI of the values for each variable. The Kolmogov-Smirnov (KS) test and a~     2x2 mixed model ANOVA will be used. Intergroup effect sizes will be calculated (Cohen's d).~   "
121233|NCT01980628|"~     Phase 2, open-label, non-randomized, monotherapy study to evaluate the safety and efficacy of~     ibrutinib in subject with relapsed/refractory Marginal Zone Lymphoma (MZL).~   "
121234|NCT01980615|"~     This is a Phase I, Randomized, Double-Blind Within Device, Single-Dose, Four-Period,~     Six-Treatment, Cross-Over Study Evaluating the Safety and Pharmacokinetics of Three Doses of~     Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (BGF MDI), One Dose of~     Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (GFF MDI), and Two Doses of~     Symbicort® Inhalation Aerosol in Healthy Volunteers. The primary objective of the study is to~     determine a dose of budesonide that when formulated with glycopyrronium and formoterol~     fumarate in BGF MDI provides comparable systemic exposure [pharmacokinetics (PK)] to~     budesonide following administration of Symbicort MDI.~   "
121235|NCT01980602|"~     Title: How does exercise improve the calf muscle in patients with poor blood supply to their~     leg?~      Purpose of the project: Patients with peripheral arterial disease have a poor blood supply to~     their lower leg. The reduced inflow prevents the leg from utilising nutrients and oxygen as~     easily as a healthy leg would. This causes pain when walking (intermittent claudication),~     which often occurs after a reproducible distance e.g. every 50 yards. These patients have a~     reduction in their quality of life as they feel embarrassed in social situations e.g. walking~     around town requires multiple breaks, so they tend to avoid this and isolate themselves more.~      One treatment for claudication is exercising until the pain comes on; which most are~     reluctant to do. Walking up to three times a week for an hour, can double most people's~     walking distances, but doesn't always. The reason why some improve with exercise and others~     do not remains unknown.~      This project will be the first randomised controlled trial of exercise in claudicants that~     focuses on the adaptations that occur in the muscle at a cellular level. We wish to compare~     muscle cells from a group that have exercised and group that have not. We will focus on the~     change in muscle cell size and function at present, and later progress to why and how this~     happens.~      Methods: We will take measurements at the start of the study (baseline), after 6 weeks and~     then 3, 6 and 12 months. These measurements will be of a patient's fitness, actual walking~     distances and blood samples. At the time of surgery, muscle from the calf will be taken from~     the affected leg. This will be processed at the University's biomedical science department to~     look at the different types of muscle fibre and how efficiently they are working.~   "
121236|NCT01980589|"~     The primary objective was to determine the maximum tolerated dose of carfilzomib given twice~     weekly in combination with cyclophosphamide and dexamethasone for patients with newly~     diagnosed multiple myeloma.~   "
121237|NCT01980576|"~     The purpose of the study is:~        -  to measure sensitization of the nociceptive system at patients with low back pain in~          order to carry out a necessary surgical procedure~        -  to examine a possible association between low back pain and degenerative changes~        -  to analyse if low back pain is related to the clinical result 6 months after surgery~        -  to set up a model for pre-operative measurement of pain.~   "
121238|NCT01980563|"~     Monitoring ovarian stimulation for in vitro fertilization (IVF) and intracytoplasmatic sperm~     injection (ICSI) can be simplified by reducing the procedure to measuring follicles by~     ultrasound. Proponents of a simplified procedure claim that the procedure can be reduced to~     simple monitoring by ultrasound while maintaining results (numbers of mature oocytes,~     percentage of pregnancy and live birth rates). On the other hand simultaneous blood sampling~     for measuring hormone levels is still the state of the art in many clinics. A large review~     (Cochrane review) stated that although there was no clear evidence for a better outcome,~     combined cycle monitoring was still recommended until it could be proven that ovarian~     hyperstimulation can be avoided without hormonal monitoring. Investigators therefore perform~     a study that compares the results between 2 groups: those with ultrasound monitoring and~     those with combined monitoring. Deciding when to plan the retrieval of the oocytes can depend~     on subtle differences in the number of large follicles measured by ultrasound, but also on~     hormonal levels in the blood of the patient. Therefore the investigators planned a randomized~     study in the group of patients with combined monitoring. The investigators examined if~     delaying the moment for planning the moment of oocyte retrieval by 24 hours had any effect on~     the number of mature oocytes and pregnancy rates and what the effect of rising progesterone~     levels might be. The investigators hypothesis was that combined monitoring could lead to~     better results since recent studies have thought that rising progesterone levels, if found,~     have a negative impact on pregnancy rates. On the other hand the investigators expect to find~     that waiting for larger follicles in cases with normal progesterone levels lead to a better~     oocyte yield.~   "
121239|NCT01980550|"~     Nicotine replacement treatment (NRT) can be efficacious for smoking cessation, but used by~     only a minority of smokers in China. Pharmacogenetic matching may improve treatment outcomes~     for NRT in subgroups of smokers. The investigators evaluated the efficacy and safety of~     sublingual nicotine tablets (SNT) for smoking cessation and the association of~     catechol-O-methyltransferase (COMT) genotype with efficacy in this smoking cessation trial~     among Chinese smokers.~   "
121240|NCT01980537|"~     Wire-crossing of a chronic total coronary occlusion (CTO) is time-consuming and limited by~     the amount of contrast agent and time of radiation exposure. Magnetic wire navigation might~     accelerate wire-crossing by maintaining a coaxial vessel orientation. This study compares~     magnetic with conventional wire navigation for recanalization of CTOs.~   "
122045|NCT01970007|"~     The purpose of the VIVO Clinical Study is to evaluate the safety and effectiveness of the~     Zilver® Vena™ Venous Stent in the treatment of symptomatic iliofemoral venous outflow~     obstruction.~   "
121241|NCT01980524|"~     There is evidence that inhibition of FFA-release by acipimox is associated with a significant~     decrease in myocardial lipid content (MYCL) as well as the ejection fraction (as a marker of~     systolic left ventricular function) in healthy subjects, indicating, that the heart is~     dependent on a constant supply of free fatty acids in order to guarantee normal cardiac~     function, and it further indicates, that the heart is not able to cover its energy demand by~     switching to glucose oxidation.~      Since that phenomenon, better known as metabolic inflexibility has been mainly described in~     patients with diabetes, we aim to investigate the impact of FFA-inhibition on MYCL and~     cardiac function in patients with overt type 2 diabetes.~   "
121242|NCT01980511|"~     The NeuroVISION Study will characterize the incidence, impact, and risk factors of covert~     stroke in adults undergoing noncardiac surgery. We will determine the incidence of acute~     covert stroke using an MRI study of the brain in the days following noncardiac surgery. We~     will characterize the epidemiology and the impact of covert stroke in patients undergoing~     noncardiac surgery, and its association with cerebral deoxygenation.~   "
121243|NCT01980498|"~     The primary objective of the present phase IIIb study is to assess the efficacy of FPNS~     compared with Physician Choice-Usual Care (PC-UC) in the reduction of swallowing predictable~     BTP in head and neck cancer patients undergoing radiotherapy with or without chemotherapy.~   "
121244|NCT01980485|"~     Narrative: Tobacco smoking remains the single biggest cause of premature death in the United~     States and the leading cause of cancer and death from cancer. There is therefore an urgent~     need to find effective but practical ways of helping smokers to quit and stay quit. This~     randomized trial aims to evaluate two promising methods of helping smokers to quit and to~     stay quit.~      Design: This is a randomized controlled smoking cessation trial with two stages.~      In Stage 1, 225 smokers will be recruited and at assessment they will be randomly allocated~     to receiving feedback on their Lung Age as estimated by their Forced Expiratory volume of~     air from lungs in one second (FEV1), and exhaled carbon-monoxide (CO) (Intervention group 1)~     or to have these measured but not fed back in a manner designed to enhance motivation to quit~     (Control group 1). All participants will be provided with group counseling (6 weekly~     sessions, with the target Quit Date on the day of the second group meeting), and transdermal~     nicotine patches.~      Main outcome measure: Stage 1, Past week tobacco abstinence biochemically validated by~     exhaled CO < 10 ppm at visit 7 (4 weeks after Target Quit Date).~      In Stage 2 (starting visit 7), all participants attending visit 7 (28 days after their Target~     Quit Date), will be randomly allocated to receiving either the Forever Free relapse~     prevention materials (Intervention 2) http://www.smokefree.gov/pdf.html or the Surgeon~     General's Guide How Tobacco Smoke Causes Disease (Control 2)~     http://www.cdc.gov/tobacco/data_statistics/sgr/2010/consumer_booklet/index.htm.~      All randomized participants will receive a follow-up phone call a week later to remind them~     to read and use the materials they have been given, and will attend a follow up visit (8), 6~     months after their initial Target Quit Date.~      Main outcome measure: Stage 2. Among those who have not smoked in the previous week at visit~     7, sustained tobacco abstinence (including no tobacco use in prior 7 days), validated by~     exhaled CO < 10 ppm at the 6 month visit(8) AND not smoking for any 7 consecutive days during~     the prior 5 months (definition of a relapse in this study).~      Hypothesis: Smokers who are provided with lung age feedback at assessment will have higher~     quit rates 28 days after the target quit date.~   "
121245|NCT01980472|"~     A phase II Study of an adapted chemotherapy regimen plus bevacizumab in elderly non-small~     cell lung cancer patients selected by geriatric assessment~   "
121246|NCT01980459|"~     In most diabetic patients where low blood magnesium levels occur the important depletion of~     cellular levels is usually not measured. This study will measure both blood and oral mucosal~     cell magnesium levels before and after 3 months of supplementation with magnesium tablets~     (the recommended dietary amount of 336 milligrams per day). These magnesium levels will be~     correlated with blood levels of indicators of inflammation (eg C reactive protein) to see~     whether the cellular levels are more reliable than blood levels of magnesium for appropriate~     treatment of magnesium deficiency in diabetic patients.~   "
121247|NCT01980446|"~     Determination of vital and functional outcome in comatose survivors after cardiac arrest is~     principally based on the identification of predictors of non-awakening, using by clinical,~     biological and electrophysiological tools. In patients without presence of non-awakening~     predictors, it would be of interest to identify predictive criteria of awakening. The~     presence of mismatch negativity during the cortical auditory-evoked potential could~     contribute to further progress in neurological prognostication of these patients. However, at~     this time, its prognostic value has been insufficiently studied and the optimal time of~     realization remains unknown.~   "
121248|NCT01980433|"~     Wilson disease is a genetic disorder resulting in copper accumulation in liver, brain and~     eye. The neurologic complications include dystonic syndrome, which is a prolonged and~     excessive muscle activation responsible for abnormal postures. Hand dystonia prevents daily~     life activities such as writing, which is particularly disabling, since writing is the only~     mean of communication in these patients with significant slurred speech. Treatment is limited~     and only partially effective.~      Low frequency (<or=1Hz) repetitive transcranial magnetic stimulation (rTMS) has shown~     inhibiting properties when applied over the cortex. Since dystonia has been correlated to~     hyperactivation of the neurons of the somatosensory cortex (SSC), we hypothesize that one~     single 20-minute session of 1 Hz rTMS applied on left SSC will improve writing of the right~     dystonic hand, assessed immediately at the end of the session.~   "
121249|NCT01980420|"~     Improved results for sleeve gastrectomy could be possible if more was known about the~     surgical / mechanical factors that affect outcome.~   "
121250|NCT01980407|"~     In China, S-1 is an novel oral fluoropyrimidine with demonstrated high efficacy on~     gastrointestinal cancer. The new regimen with oxaliplatin and leucovorin is expected to~     achieve more encouraging efficacy on gastric cancer. This study is aimed to evaluate the~     feasibility of the SOL regimen on efficacy and tolerability on Chinese patients with advanced~     gastric cancer.~   "
121251|NCT01980394|"~     Intraluminally shed viable tumor cells might contribute to local recurrence in cancer of the~     esophagus and the cardia. The aim of the the study was to establish a method of mechanical~     lavage of the remaining part of the esophagus and, hence, to reduce the intraluminal cancer~     cells before doing the esophageal anastomosis.~   "
121263|NCT01980238|"~     Most surgeons suggest the use of fecal diverting to address the high morbidity and mortality~     associated with anastomotic leakage (AL) in patients with high risk factors on AL who are~     undergoing anterior resections. Although debate about the use of defunctioning stoma~     continues, meta-analyses and randomized multicenter trial results support the use of~     defunctioning stoma in lower anterior resection(LAR). This exploratory study was conducted to~     evaluate the efficacy and safety of a new diversion method called spontaneously closed~     cannula ileostomy (SCCI), which was designed to protect rectal anastomosis in patients with~     high risk factors on AL. Results of SCCI were compared to those of the loop ileostomy (LI)~     method.~   "
121252|NCT01980381|"~     Depression and anxiety are among our most common diseases and the prevalence is increasing.~     When suffering from depression or anxiety, the individual's ability to cope with everyday~     life occupations is decreased, as well as the ability to relate to others. The Tree Theme~     Method® (TTM) is a treatment method. The purpose is to enhance the ability to develop~     strategies for occupations in everyday life and relationships with others. The method~     involves using creative activities to create a life story focusing on everyday occupations~     and to create an imagination of future possibilities/goals. The TTM is a short-term therapy~     with five sessions. The treatment also implies that the patient is asked to identify various~     homework tasks to perform between the sessions.~      The aim of the project is to investigate the effects of the TTM compared to a control group~     for people with depression and anxiety diagnosis. The intention is to examine the effect on~     outcome measures regarding psychological symptoms, everyday occupations and health. The study~     has been approved by the Regional Ethical Review Board.~      The project is a randomized multicenter study with an intervention group and a control group.~     A total of 130 patients will be included. Inclusion criteria are patients with depression~     and/or anxiety in the age of 18-65 years and who have problems with their everyday~     occupations. Exclusion criteria are individuals with a severe somatic illness or psychosis~     and/or who have difficulties to understand and fill out self-rating questionnaires.~      The project implies that doctors will refer appropriate patients to the occupational~     therapist. After informed consent each patient will be drawn to the TTM or control. Before~     and after the treatment, as well as 3 and 12 months after finished treatment the patient will~     meet a project assistant in order to respond to questionnaires regarding psychological~     symptoms, everyday occupations and health.~      The study is a collaborative project involving the Region Skåne, Kronoberg County Council,~     and Jönköping County Council. Doctors will recruit patients and occupational therapists will~     perform the treatment. The research team comprise of researchers from Kronoberg County~     Council (B Gunnarsson and K Hedin), Lund University (C Håkansson) and School of Health~     Sciences in Jönköping (P Wagman).~   "
121253|NCT01980368|"~     This pilot clinical trial studies how well Tai Chi Easy works in treating cancer survivors~     with peripheral sensory neuropathy. Tai Chi Easy is a simple and repetitive form of exercise~     that consists of movements with meditation and may improve peripheral neuropathy symptoms~     among cancer survivors.~   "
121254|NCT01980355|"~     Major surgery can result in blood loss that can require a blood transfusion during and/or~     after surgery. Tranexamic acid is a medication that was first introduced in the 1960s as a~     treatment for heavy menstrual bleeding. Over the past 20 years it has been used and studied~     in patients undergoing open-heart surgery, liver transplantation, and urologic surgery. We~     believe tranexamic acid may possibly decrease bleeding related to major surgery, resulting in~     reduced blood loss, lower blood transfusion rates, and possibly decreased hospital costs~     related to your surgical hospital stay.~      In this study, you will receive either the drug tranexamic acid or a placebo. The placebo~     looks like the tranexamic acid, but does not have any active ingredient in it. The treatment~     you get will be chosen by chance, like flipping a coin. You will have equal chance of being~     given the tranexamic acid or the placebo. In this study, both the tranexamic acid and the~     placebo are considered research.~   "
121255|NCT01980342|"~     This study evaluates whether there is an interaction between etonogestrel, the progestin~     hormone released by the contraceptive implant Nexplanon, and efavirenz, a common medication~     used to treat HIV. The endpoints measured in this study will help determine if such an~     interaction leads to decreased contraceptive efficacy of the contraceptive implant.~   "
121256|NCT01980329|"~     The purpose of this study is to evaluate the influence of genetic polymorphism of cytochrome~     P450 3A5 on pharmacokinetics of maraviroc and its oxidative metabolites~   "
121257|NCT01980316|"~     Argatroban is a selective thrombin inhibitor, and previous study had suggested that~     argatroban use post percutaneous coronary intervention could potentially prevent reocclusion.~     But there has no study on large sample of argatroban treated restenosis vertebral artery~     stenting. This study will test the safety and efficacy of the argatroban on prevent Occlusion~     and Restenosis in patients with Extracranial vertebral Artery Stenting.~   "
121258|NCT01980303|"~     The purpose of this Phase 1 study is to characterize the pharmacokinetic profile (what the~     body does to the medication) of esketamine when given by the intranasal route (through the~     nose) to healthy adult Japanese and Caucasian participants.~   "
121259|NCT01980290|"~     The purpose of this study is to collect information on the efficacy, safety and tolerability~     of telaprevir (in combination with other medications), in patients who have a history of~     intravenous drug use with genotype 1 chronic hepatitis C, under substitution therapy (eg.,~     methadone, buprenorphine) and/or followed in addiction centres.~   "
121260|NCT01980277|"~     The overall rationale of this study evaluating tolerance and efficacy of LY2780301 in~     combination with paclitaxel in HER2-negative, inoperable locally advanced or metastatic~     breast cancer (MBC) is based on :~        -  the medical need in this population with either hormonal-resistant or unsensitive and/or~          rapidly progressive disease~        -  the preclinical evidences for involvement of PI3K/AKT pathway in tumor progression and~          drug resistance, including taxanes as well as its potential reversion by AKT inhibition~        -  the high level of frequency of PI3K/AKT activation in HER2-negative MBC~        -  the in vitro and in vivo preclinical activity of LY2780301, and its synergistic~          combination with various anticancer agents, including taxanes~        -  the favourable profile of tolerance of LY2780301 in phase I trial~      Weekly paclitaxel is conventionally administered at 80 mg/m²/week and is a standard treatment~     in breast cancer (BC) As described above, LY2780301 500 mg once daily has been established as~     the RP2D in phase I single agent trial.~      Evidence of pharmacodynamic activity was noted at 400-500 mg QD. Conservatively, the first~     dose level to be explored will be LY2780301 400 mg QD and paclitaxel 70 mg/m²/week.~   "
121261|NCT01980264|"~     In our research, the investigators use the non-invasive 1230 nm ultra-fast laser as the light~     source, and utilize the non-linear light microscopic system to observe your skin. This~     microscopic system is successfully developed by the Graduate Institute of Photonics and~     Optoelectronics, National Taiwan University, and has not been commercialized yet. In the~     past, observations by this technology were performed on the skin of five subjects. The early~     stage of the skin clinical trial was approved by Research Ethics Committee of National Taiwan~     University Hospital. After the trial, the tested sites of subjects were evaluated by a~     dermatologist immediately, several hours, 24 hours, 3 days, and 1 week. There were no~     inflammatory symptoms, no skin color change, no pigmentation, no wound, no blister formation,~     and no ulceration reported. According to the subjects' experiences, they felt no discomfort~     during the experiment. After the experiment, there were no inflammatory symptoms and signs in~     the observed skin areas. Therefore, the preliminary trial showed that this technology is safe~     for the subjects.~   "
121262|NCT01980251|"~     Delirium in the intensive care unit is an acutely developed brain dysfunction affecting up to~     80 % of patients. It is associated with significantly increased morbidity and mortality~     during admission and post-discharge. The mechanism behind the condition is poorly understood~     but assumably multifactorial, and the purpose of this study is to investigate the~     pathophysiology further.~   "
121264|NCT01980225|"~     In our centre, the implantation rate of frozen blastocysts (cryopreserved using~     vitrification)was 20,3% (Van Landuyt et al. 2011). This implantation rate is lower when~     compared to data from other observational studies. Retrospective studies have shown that~     artificial shrinkage of the blastocoelic cavity (also called collapse) and dehydration of the~     blastocyst just before vitrification can have a positive effect on the survival after~     warming. This collapse can be induced by using a laser. The study of Iwayama et al. 2010 has~     shown a similar survival rate but an increase in the implantation rate of collapsed~     blastocysts compared to non-collapsed blastocysts.~      The aim of the study is to investigate the effect of artificial shrinkage by laser-induced~     collapse on the implantation potential of vitrified-warmed day 5 or day 6 blastocyst stage~     embryos in a prospective randomised controlled trial.~   "
121265|NCT01980212|"~     In pre-clinical study we found that the thioredoxin reductase activity of serum harbours huge~     difference between cancer patients and non-cancer patients, the enzyme activity elevated~     remarkably among cancer patients, and after any kind of treatment serum thioredoxin reductase~     activity declined remarkably, so we hypothesis that serum thioredoxin reductase activity~     could be a warning marker for early progression of first-line treatment for advanced~     non-small cell lung cancer~   "
121266|NCT01980199|"~     This study is designed to determine the efficacy of Fexinidazole as an oral treatment in~     Visceral Leishmanisasis sudanese adults patients.~      The results of this proof of concept study will allow to make a decision on whether to~     proceed with clinical development of Fexinidazole for visceral leishmaniasis.~   "
121267|NCT01980186|"~     This study will use linear 2D ultrasound imaging to look at the brain of individuals~     diagnosed with autism and their siblings. This is called transcranial ultrasound (TUS). It is~     hypothesized that TUS will allow real-time imaging of the fluid spaces outside the brain and~     will further allow the imagining of brain areas important to language and social function.~   "
121268|NCT01980173|"~     This study concerns women diagnosed with postpartum hemorrhage and requiring sulprostone~     therapy. Included patients are randomized to two arms: the Sulprostone + Bakri balloon arm~     versus the Sulprostone alone arm.~      The main objective of this study is to compare the efficiency of a care strategy including~     the Bakri balloon to that of routine care without the Bakri balloon via a cost-consequence~     study juxtaposing costs and the necessity of invasive procedures (arterial embolization,~     ligation of arteries, hysterectomy, intrauterine sutures) for controlling postpartum~     hemorrhage.~   "
121269|NCT01980160|"~     The primary study hypotheses are that, without increasing doses of breakthrough medications~     or device intolerance, the Nometex™ device worn for 5-days beginning with the day of~     chemotherapy administration in women with ovarian or advanced endometrial or cervical cancer~     will, as an adjunct to standard-of-care anti-emetics, reduce vomiting episodes, and reduce~     the severity of nausea.~      The secondary hypotheses are that the Nometex™ device reduces acute (Day 1) emetic episodes,~     day 1 and days 2-5 severity of nausea, and delayed (days 2-5) emetic episodes without~     increasing doses of breakthrough medications or device intolerance.~   "
121270|NCT01980147|"~     Severe mental illness such as schizophrenia and mood disorders typically develops at a young~     age and can cause life-long disability. Currently available treatments cannot cure severe~     mental illness. This makes it important to find ways to prevent severe mental illness in~     young people before it has a chance to develop. This research study will pilot a new~     preventive intervention for young people who are at high risk of developing severe mental~     illness. The investigators will target early preceding factors (the 'antecedents') to severe~     mental illness which includes anxiety, unusual hearing and visual experiences, the loss of~     previously acquired abilities, and sudden and unpredictable changes in mood. These~     antecedents strongly predict an increased risk of developing severe mental illness. They are~     often impairing and distressing to the individual but can be improved with self-management~     skills and parent training, and they are present in the individual years before the onset of~     severe mental illness which makes them an ideal target for early intervention. The goal is to~     intervene early enough in the young person's life that severe mental illness can be~     prevented, hopefully leading to a happy, healthy and productive adulthood. The investigators~     want to test the acceptability and short-term efficacy of this new preventive intervention.~   "
121271|NCT01980134|"~     To demonstrate the use of WavSTAT4 system during colonoscopy in identifying diminutive~     colorectal lesions (e.g. hyperplastic polyps) that can be resected and discarded (or even~     left in-situ) without adverse clinical impact.~   "
121272|NCT01980121|"~     Food residue in the stomach of patients scheduled to have surgery is considered a major risk~     factor for pulmonary aspiration of gastric contents. The resulting respiratory compromise~     after aspiration is associated with significant morbidity and mortality. The risk of~     pulmonary aspiration is especially important in pregnant women, as they may often require~     surgery without having observed appropriate fasting. In pregnant patients scheduled for~     elective surgery, standard preoperative guidelines apply as the general non-pregnant surgical~     population (8-hour fasting of solid food and 2-hour fasting of clear fluids). A bedside~     ultrasound assessment of the status of the gastric content and volume would be of great value~     for the clinician. This technique has recently been shown very promising in fasted~     non-pregnant patients scheduled for elective surgery. Therefore, it is important to study its~     feasibility in the pregnant population scheduled for elective Cesarean Delivery.~      The investigators hypothesize that no residual solid contents will be found in the gastric~     sonography, and a small volume of gastric fluid will be observed in the antrum in both supine~     and right lateral decubitus.~   "
121273|NCT01980108|"~     Solid food or fluid residue in the stomach is always a major concern when patients need~     medical procedures under sedation or general anesthesia, due to the high risk of pulmonary~     aspiration of the stomach contents. This is especially important in emergency procedures,~     when a fasting period is not observed. The aspiration of the stomach contents into one's~     lungs can lead to serious complications (such as severe respiratory failure). Information~     from a bedside ultrasound assessment of the stomach may be a very useful tool to decide~     whether or not it's safe to proceed, cancel or delay a surgical procedure.~      The investigotrs hypothesize that a mathematical model can be constructed to predict clear~     fluid volume in the stomach of non-labouring pregnant patients, as it has been developed in~     healthy adult volunteers.~   "
121277|NCT01980056|"~     Study WCMC IST/VOS/MDS evaluates the safety and tolerability of escalating doses of vosaroxin~     in adult patients with pathologically confirmed Myelodysplastic Syndrome, or MDS, (< 20%~     blasts in bone marrow, peripheral blood, or both) by World Health Organization (WHO)~     classification with an intermediate 2 (INT-2) or high-risk score (ie, ≥ 1.5) as assessed by~     the International Scoring System (IPSS) after failure of hypomethylating agent-based therapy.~     Based on 3 completed studies and xenograft models, Vosaroxin is hypothesized to be safe and~     will effective in this patient population.~   "
121278|NCT01980043|"~     The purpose of this study is to evaluate the safety and feasibility of endoluminal rectal~     prolapse repair under sedation and local anesthesia using CO2 colonoscopy to fix the rectum~     with sutures to the abdominal wall under needlescopic control. Further, investigators will~     evaluate the short and long-term clinical outcomes after this novel approach to treating~     rectal prolapse.~   "
121279|NCT01980030|"~     This is a Phase I/II multicenter study which aims to assess the toxicity profile of~     Romiplostim in patients with transfusion-dependent thrombocytopenia after allogeneic HSCT.~      A total of 24 patients with transfusion-dependent thrombocytopenia after allogeneic HSCT will~     be included.~      The main endpoint is the incidence and severity of adverse events.~   "
121280|NCT01980017|"~     The incidence of type 2 diabetes mellitus (T2DM) is increasing rapidly. The combination of~     T2DM and smoking is particularly lethal, as smokers with T2DM are significantly more likely~     to develop a number of health related complications. Community-based diabetes education~     programs (DEPs) have been developed to support patient self-care behaviours (e.g. adherence~     to oral medications, insulin therapy, nutrition management, regular blood glucose monitoring,~     and physical activity); however, specific assistance for smoking cessation is rarely~     provided. Our investigative team has developed a knowledge transfer and practice change~     process to introduce evidence-based interventions for smoking cessation into clinical~     practice settings. This process is known as the Ottawa Model for Smoking Cessation (OMSC).~     Investigators believe there is an opportunity to use the OMSC intervention to dramatically~     enhance the effectiveness of DEPs in addressing smoking cessation among smokers with T2DM,~     and in so doing, improve quit rates in this high risk population.~      The purpose of this project is to evaluate the effectiveness of the Ottawa Model for Smoking~     Cessation (OMSC) intervention in multiple diabetes education programs (DEPs) in Ontario. A~     two-level recruitment strategy will be employed. Eighteen DEPs will be recruited, and then a~     consecutive sample of eligible smoker-patients will be recruited from each DEP over a 6-month~     recruitment period. Investigators want to test the impact of the OMSC intervention on quit~     rates among smokers with diabetes and pre-diabetes referred to these programs. Investigators~     will conduct a matched-pair cluster design trial at 18 DEPs in Ontario. These sites will be~     matched based on number of annual referrals for diabetes education (≤ 500/year or >~     500/year). Within each pair, sites will be allocated randomly to either OMSC intervention or~     control group. Following randomization, the OMSC program will be implemented at the~     intervention sites over a 6-month period. Following the implementation period, a consecutive~     sample of smokers will be recruited from both OMSC intervention and control DEPs over a~     6-month recruitment period. It is estimated that this will yield a sample of approximately~     445 smokers in each of the OMSC intervention and control groups. The primary outcome will be~     the biochemically-validated 7-day point prevalence abstinence rate six months after an index~     visit to the DEP. Secondary outcomes will include: rates of identification and intervention~     of smokers, and diabetes educators' attitudes, confidence, and perceptions of barriers and~     facilitators to implementing smoking cessation support as part of routine care.~      If proven effective, the OMSC is appropriate for implementation in DEPs across Canada and~     could have profound impacts on patient and community health.~   "
121281|NCT01980004|"~     The purpose of this study is to compare the role of potassium citrate supplementation with~     dietary education versus dietary education alone in the reduction of stone risks and events~     in patients with predominantly calcium phosphate kidney stones.~   "
121282|NCT01979991|"~     To develop a computer program that will improve CT image quality and decrease the amount of~     x-ray radiation that future patients may be exposed to when they have a CT examination.~   "
121283|NCT01979978|"~     School-based interventions are generally ineffective for preventing weight gain in children.~     In 2007, a group from the University of British Columbia, developed a program called Healthy~     Buddies, that relied on peer mentors to help young children adopt healthy living behaviours.~     Pilot studies revealed that the program effectively prevented weight gain in children. This~     trial had never been tested on a large scale using a more scientifically sound study design.~     We developed a large school-based randomized trial to overcome that limitation and test the~     hypothesis that that a school-based peer-led healthy living program would reduce adiposity~     and increase physical activity among children 6-12yrs old.~   "
121284|NCT01979965|"~     The purpose of this study is to find out whether mitral regurgitation (or a leaky heart~     valve) caused by ischemic heart disease (decreased blood flow to heart muscle) will improve~     after administration of ranolazine.~   "
121285|NCT01979952|"~     This is an 6 month multi-centre, prospective, randomized, placebo controlled, double blind~     clinical trial followed by conversion of each arm to active nintedanib for an additional 6~     months comparing the effect of nintedanib 150mg bis in die (BID twice daily) on the~     progression of IPF measured by using High Resolution Computerized Tomography(HRCT), lung~     function, functional component (6MWT), biomarkers, and PRO component (PROs) with continued~     treatment and assessments for up to 18 months.~   "
121286|NCT01979939|"~     To demonstrate the effectiveness of DCV 3DAA fixed dose regimen in treatment naive and~     treatment experienced non-cirrhotic subjects~   "
121287|NCT01979926|"~     The Purpose of A Multicenter, Randomized, Double-blind, Placebo-controlled to Evaluate the~     Efficacy, Safety and Pharmacokinetics of N02RS1 600mg and 1,200mg per day in Patients With~     acute and acute exacerbation of chronic bronchitis for 7 days.~   "
121288|NCT01979913|"~     Increased intraocular pressure (IOP) has been identified as the most important risk factor~     for the development and the progression of glaucoma. Data from large interventional studies~     have shown that a decrease of IOP is associated with a reduced risk of progression of the~     disease. This underlines the importance of a potent and save IOP lowering therapy. The~     introduction of preservative free tafluprost offers a new treatment possibility using a~     potent topical prostaglandin analogue without the disadvantages of a co-administered~     preservative. The current study seeks to investigate the effect of an 8 week therapy with~     preservative free tafluprost on intraocular pressure in patients with ocular hypertension or~     primary open angle glaucoma having an IOP of 30 mmHg or more.~   "
121299|NCT01979770|"~     This study aims to investigate the relationship of the various exposures during infancy and~     childhood on later health and development of adolescents. Various exposures to be assessed~     include, but not limit to, nutritional status, body composition, energy expenditure, dietary~     intake, micronutrient status, breastfeeding, lifestyle, and other environment exposures.~      The study will specifically aim to respond these research questions:~      1.1 What are the factors associated with overweight, obesity, and stunted in adolescents? 1.2~     What are the factors associated with increased risk of NCDs during adolescence? 1.3 What are~     the factors associated with cognitive functioning during adolescence? Since numerous~     variables were collected, additional research questions can be possibly studied or other~     interested variables can be included in the future.~   "
121289|NCT01979900|"~     Mycobacterium Vaccae for Injection (Trade Name Vaccae) is a kind of bio-products developed~     by Anhui Zhifei Longcom Biopharmaceutical Co.,Ltd.,and got The New Drug Certificate in~     1999. Vaccae has been approved for adjuvant therapy of tuberculosis(TB), and is also the only~     recommended drug in TB immunotherapy by WHO. It was approved for production and sale by Anhui~     Zhifei Longcom Biopharmaceutical Co.,Ltd. in 2001, and got favourable comment in therapy of~     tuberculosis.~      The purpose of this study is to add new indications for Vaccae, mainly to prevent~     Tuberculosis for high risk groups of Tuberculosis Infection . In December 2012, China Food~     and Drug Administration approved of the plan Phase III Clinical Study of Efficacy and Safety~     of Mycobacterium Vaccae to Prevent Tuberculosis in high risk groups of Tuberculosis~     Infection. In the test, 10,000 cases whose skin tests of PPD are strongly positive are~     enrolled. Using random, double-blind, and placebo-controlled methods, the study is carried~     out to evaluate the efficacy and safety of Vaccae in preventing Tuberculosis. Meanwhile, in~     this test, TB incidence and degree of pathological changes of experimental group are lower~     than that of control group, and no drug-related SAEs are reported in treatment groups.~   "
121290|NCT01979887|"~     This is an exploratory study to evaluate endpoints used to characterize participants with and~     without meibomian gland dysfunction (MGD) and will evaluate the correlation between signs and~     symptoms of MGD. No investigational drug will be administered in this study.~   "
121291|NCT01979874|"~     Investigators hypothesize that high-dose n-3 polyunsaturated fatty acids (PUFA) oral~     supplementation will improve systemic inflammation, vascular function, and symptomatic status~     of patients with PAD. Investigators will explore novel mechanistic pathways by which n-3 PUFA~     affect PAD, evaluating the role of specialized lipid mediators involved in the resolution of~     inflammation.~   "
121292|NCT01979861|"~     The purpose of this study is to determine if the AEGEA Vapor System for endometrial ablation~     is safe and effective for reducing menstrual blood loss in women with excessive uterine~     bleeding (menorrhagia)~   "
121293|NCT01979848|"~     Urinary incontinence and sexual dysfunction are potential side effects for men undergoing the~     successful removal of the cancerous prostate via surgery. Hypothermic cooling via the~     investigational Endorectal Cooling Balloon has been shown by our group to significantly~     reduce long term urinary incontinence and may reduce sexual dysfunction in men after robotic~     prostatectomy, and improve the patient's long term quality of life (QOL). However before~     successful translation of the endorectal balloon can proceed into the world wide usage, we~     must understand:~        1. How effectively the tissues for continence and sexual function are cooled within the~          pelvis.~        2. What is the capacity of vascularized structures (i.e. the neurovascular bundle) to 'cool~          sink' or diminish the effective cooling and~        3. Determine if the endorectal balloon can be re‐designed for improved QOL outcomes in men.~      This research study marries two new techniques of Thermal MRI imaging and Endorectal cooling~     for prostate cancer surgery. MRI is non‐invasive. A simple confirmation of effective~     hypothermic cooling can be achieved by novel MRI thermal mapping of the cooling gradient as~     it comprehensively sweeps through the rectum across the urogenital pelvis. MRI with~     temperature adaptive software can accurately map these gradients with non‐invasive technique,~     and answer formidable questions of the effectiveness of hypothermic cooling of the prostate~     and its direct translation into improved continence and sexual function after surgery. The~     purpose of this research study is to use Magnetic Resonance Imaging (MRI) and Thermal MRI~     with subjects who will receive the investigational endorectal cooling balloon to help further~     understand how the cooling balloon works, which may translate to other uses in the future,~     including the diagnosis of patients at a high risk of developing prostate cancer.~   "
121294|NCT01979835|"~     The GyneFix-Viz is a frameless copper intrauterine device (IUD) used for contraception. The~     GyneFix IUD has been marketed in Europe and Asia for about 10 years. The new anchor in the~     GyneFix IUD was designed to be more visible on ultrasound and this could improve safety by~     reducing failed insertions and perforations. We now need to know how easy it is for doctors~     to see and measure the distance of the anchor to the outside of the uterus. The purpose of~     this open, prospective, observational study is to assess the feasibility of measuring the~     distance from the serosa of the uterus to the anchor following insertion of the GyneFix-Viz~     and at follow-up 6-8 weeks later. Secondary objectives are to assess the ease and pain of~     insertion, the acceptability of the device to Canadian women and any complications. We will~     also compare expulsion rates in post-abortion and other women.~   "
121295|NCT01979822|"~     The clinical study aims to investigate the numbers of predefined complications in the first~     six month after implantation of the implantable LENUS Pro® medications pump for intravenous~     application of treprostinil sodium in patients with PAH.~      The manufacturer is Tricumed GmbH, Germany; exclusive marketing rights: OMT GmbH & Co KG~     78665 Frittlingen, Germany.~   "
121296|NCT01979809|"~     The purpose of this study is to conduct a two site, three arm randomized intervention study~     to improve fruit and vegetable intake, improve whole grain intake and reduce sweetened~     beverages in young adults aged 21 to 30 years. This work is potentially very high impact in~     light of growing overweight and obesity and decreased health status overall, and potential~     dietary benefits to children of our target age group.~   "
121297|NCT01979796|"~     It is well established in studies across several countries that tobacco smoking is more~     prevalent among schizophrenic patients than the general population. Electronic cigarettes~     (e-cigarettes) are becoming increasingly popular with smokers worldwide. To date there are no~     large randomised trials of e-cigarettes in schizophrenic smokers. A well-designed trial is~     needed to compare efficacy and safety of these products in this special population.~   "
121298|NCT01979783|"~     Transversus abdominis (TrA) and lumbar multifidus (LM) muscle have been proposed to play key~     role in stability of the lumbosacral spine. The muscles' functional and/or structural~     deficits have been linked to the low back pain (LBP) syndrome. Evaluation of the transversus~     abdominis and lumbar multifidus muscles' function in clinical practice is scarce and not well~     defined due to number of reasons. Surface electromyography of TrA and LM muscles, as a method~     of examining muscles function, is not involved in clinical routine. Rehabilitative Ultrasound~     Imaging (RUSI) of the TrA and LM, apart from providing information about their morphology,~     could be helpful in assessing their function. Since concentric muscle contraction results in~     the shortening and thickening of the muscle, evaluation of the potential association between~     muscle's morphometry, assessed by the ultrasound, and electromyography, may be of potential~     clinical interest. However, this potential relationship is context-dependant. Our aim was to~     establish the difference in the thickness change of the TrA and LM muscle during activation~     in subjects with and without low back pain, and to establish the possible correlation between~     electromyography and the thickness change of these muscles assessed by ultrasound in both~     groups of subjects.~   "
122046|NCT01969994|"~     The purpose of this study is to determine the absorption, metabolism and excretion of~     (-)-epicatechin using the radiolabeled tracer (-)-[2-14C]epicatechin in healthy male~     volunteers observing a flavanol-/procyanidin-controlled background diet.~   "
121300|NCT01979757|"~     Breast-conserving treatment (BCT) leads to a progressive and deteriorating breast deformity.~     Fatgrafting is ideal for breast reconstruction after BCT. The most frequently utilized~     technique for fat processing is centrifugation. The PureGraft device (Cytori Therapeutics,~     USA) is a new method that involves washing and filtering the fat to prepare the graft. The~     investigators compared the subjective and objective outcomes of two fat-processing methods,~     centrifugation and PureGraft filtration.~      Thirty patients underwent breast reconstruction performed by a single surgeon (OM) after BCT~     in our department between April 2011 and September 2012. The patients were preoperatively~     divided into two groups randomly: 15 received fatgrafts processed by centrifugation, and 15~     received fatgrafts processed by washing in PureGraft bags. The patients were followed up for~     12-30 months.To measure the subjective outcome, the investigators distributed the BREAST-Q~     questionnaire to all the patients both preoperatively and one year postoperatively. The~     BCCT.core software evaluated the objective outcome of breast reconstruction by fatgrafting.~   "
121301|NCT01979744|"~     Although first generation DES reduced instent restenosis, still remained the unsolved~     problems such as stent thrombosis and restenosis in the era of DES. Second generation DES had~     been developed to improve the biocompatibility of stent coating focused on polymer compared~     to first generation DES, so that second generation stents showed better outcomes compared~     with first generation DES. On the other hands, in third generation DES, further refinement of~     DES involved more flexible stent platform. Promus ElementTM (Everolimus eluting stent, Boston~     Scientific, Nastick, MA) and Resolute Integrity® (Zotarolimus eluting stent, Medtronic~     Vascular, Santa Rosa, CA) are the third generation drug eluting stents which are designed to~     increase flexibility. In previous randomized controlled studies, both of these stents have~     shown at least non-inferior angiographic and clinical outcomes compared to second generation~     DES. However, there is lack of data about comparison of angiographic and clinical outcomes~     between Promus ElementTM and Resolute Integrity®.~      IVUS is one of the widely used intracoronary imaging devices to provide more reproducible and~     accurate information about coronary anatomy than angiography in current practice.8 Optimal~     stent expansion assessed by intravascular ultrasound (IVUS) has been reported as an important~     factor to prevent stent thrombosis or restenosis.9 Accordingly, there have been many studies~     to evaluate the procedural or clinical benefit of IVUS guided angioplasty. However, The~     clinical benefit of IVUS-guided angioplasty with stent implantation is still in a~     controversy. In the previous studies, IVUS-guided stent implantation showed positive or~     negative beneficial effect on clinical outcomes according to their study subjects. However,~     the stents used in the previous studies are less useful in current practice of cardiology and~     there is lack of data of 3rd generation DES, which have different stent profiles and outcomes~     with their predecessors.~      Thus we would perform a prospective randomized study in order to compare the efficacy of~     IVUS-guided angioplasty with conventional angioplasty-guided procedure in the long coronary~     lesion. Our main hypothesis is IVUS-guided 3rd generation DES implantation in the long~     coronary lesions would have better clinical outcomes compared with conventional~     angiography-guided strategy. We also intend to assess the clinical outcomes after Promus~     ElementTM and Resolute Integrity® implantation.~   "
121302|NCT01979731|"~     The objective this study is evaluated if job rotation (change works that function every to~     work hours)contributes to reduce absence from work to complaints musculoskeletal disorders.~     And:~        -  Improve general health status~        -  Improve musculoskelettal symptoms~        -  Improve work performance~        -  Decrease costs with absence~   "
121303|NCT01979718|"~     It was well known that the mirror therapy could decrease pain of upper-limb amputated~     patients.~      The mirror therapy is known to make a plastic change some parts of the brain perceiving the~     painful body part and modulating its signal by feedback of visual information mirrored with~     the corresponding contra-lateral normal parts.~      In this study, post-operative analgesic efficiency of the virtual reality using a mirror~     therapy after total knee arthroplasty will be evaluated.~      This clinical trial will be performed in the form of prospective, single-blind (i.e.~     assessor-blind), parallel group, randomized (allocation ratio 1:1), single cohort.~   "
121304|NCT01979705|"~     Infectious disease is the single biggest cause of death worldwide. New infectious agents,such~     as the Severe Acute Respiratory Syndrome coronavirus and new strains of influenza continually~     emerge and require new investigations to understand pathogen biology and pathogenesis in the~     host. Witness the Influenza A pandemic. Concerns about new viruses and their impact on health~     and the economy are also increasing. Current alerts sent out by the Ministry of Health (about~     the novel coronavirus and the Avian influenza A virus) are but cases in point. These likely~     reflect advances in science, which have allowed novel pathogens to be identified.~      Because of its geography, Singapore is vulnerable to new pathogens through importation or the~     global travel of its citizens. Hence we must be ever ready to meet unexpected challenges~     anytime.~      On the administrative front, Singapore General Hospital has a Disease Outbreak Task-force~     which has in place many plans that can be activated should there be a large-scale epidemic.~      What is missing thus far is a program that will enable us to perform scientific studies in~     the setting of an epidemic. Hence in this study, we will, in collaboration with the Program~     in Emerging Infectious Diseases (EID) in Duke-National University of Singapore Postgraduate~     Medical School, attempt to (i) detect novel, previously undescribed pathogens; (ii)~     characterize viruses (not necessarily novel but emerging and re-emerging) that are raising~     concern or causing clusters or epidemics in the hospital and/or country; (iii) characterize~     immune responses to such viruses in healthcare workers as well as patients (those affected by~     these viruses and those exposed to the affected). The techniques that will be used will be~     those not routinely available in a hospital's service labs.~      Some patients will remain undiagnosable with the best available technology. Since new~     laboratory tools that can detect previously undiagnosed pathogens may become available in the~     future, the study also aims to archive specimens from patients whose illnesses remain~     undiagnosed.~   "
121305|NCT01979692|"~     The hypothesis of this proposal is that needle confocal laser microscopy (nCLM) may improve~     the yield of trans thoracic needle biopsy (TTNB) of lung or mediastinal lesions by~     differentiating between viable and necrotic tissue. This may reduce the number of biopsy~     attempts and eventually the complication rate of the procedure.~   "
121306|NCT01979679|"~     The purpose of this research study is to measure how many of the dopamine receptors~     lurasidone occupies throughout the brain of patients with schizophrenia or schizoaffective~     disorder and over what time period the occupancy occurs. This is research because lurasidone~     is an investigational medication that has not yet been approved by the Food and Drug~     Administration (FDA). Dopamine receptors have key roles in many processes, including the~     control of motivation, learning, and fine motor movement. The degree of occupancy and the~     transience of occupancy D2 receptor occupancy for optimal clinical response and to prevent~     relapses is a controversial area that this study will address.~      In this study Positron Emission Tomography (PET) scanning will be performed with D2/D3 ligand~     18F-fallypride (a radioactive, injectable substance) to help the researchers measure the use~     of these receptors. Researchers hope that quantifying the amount of receptors being occupied~     by the medication will help them to determine the best dose of study medication in terms of~     improvement and least side effects related to body size and gender as well as in preventing~     relapse that may be related to hypersensitivity. Magnetic Resonance Imaging (fMRI) will also~     be performed. MRI is a scanning method which makes pictures of parts of the brain using a~     large magnetic field. This study will use a particular kind of MRI called fMRI, or functional~     MRI. fMRI takes pictures of the brain while the person is thinking or doing a simple task.~     fMRI will allow the researchers to investigate patients regional brain activation during~     cognitive (mental) and emotional tasks.~   "
121310|NCT01979627|"~     The transradial approach for coronary angiography and angioplasty is now widely used in~     catheterization laboratories worldwide, which had been shown as advantages over the~     conventional femoral and brachial approaches due to the lower incidence of bleeding and other~     cardiovascular complications. However, the transradial approach does not seem suitable for~     5-15% of patients undergoing coronary angiography and angioplasty. The ulnar artery which is~     one of the two terminal branches of the brachial artery is usually larger than radial artery~     and it may be as a potential approach for cardiac catheterization. Recently, some reports~     have demonstrated that the transulnar approach may be both feasible and safe for coronary~     angiography and angioplasty in selective patients.we performed this study to evaluate the~     safety and feasibility of transulnar approach coronary catheterization in real world~     non-selective patients.~   "
121311|NCT01979614|"~     This is a mechanistic study in patients with coronary artery disease on the effects of~     Serelaxin on micro- and macrovascular function.~   "
121312|NCT01979601|"~     This study is designed to measure the effects of LGT209 when given intravenously to patients~     with high cholesterol who are on stable doses of statin medications, and to healthy subjects~     with elevated cholesterol~   "
121313|NCT01979588|"~     Previous work has shown that the epidemiological context of a patient's presentation can~     provide important information for clinicians to aid in diagnosis and treatment. With current~     electronic health records, it is increasingly possible to perform syndromic surveillance that~     is local and specific to a patient's characteristics.~      The investigators have developed algorithms for syndromic surveillance for a number of~     conditions in which contextual information might be of use to treating clinicians. The~     syndromic surveillance algorithms already developed are for influenza-like-illness, whooping~     cough, asthma exacerbation, Group A Streptococcal pharyngitis, and gastroenteritis infection.~      The investigators plan on studying these tools with a clustered randomized control cohort~     study evaluating how clinical decision making is affected by use of these tools by outpatient~     general practitioners. The goal is to incorporate these validated algorithms into a quality~     improvement tool which will provide point-of-care clinical decision support to clinicians~   "
121314|NCT01979575|"~     1) Observe the hemodynamic and cardiovascular changes associated with the change from the~     supine to the steep Trendelenburg position, 2) Observe the hemodynamic and cardiovascular~     changes during intra-abdominal insufflation used during laparoscopic surgical procedures.~   "
121315|NCT01979562|"~     The purpose of this study is to examine the skeleton of the legs and the running style in~     order to predict a possible overuse injury.~   "
121316|NCT01979549|"~     The primary objective is to investigate the adverse events during upper gastrointestinal~     endoscopy with and without sedation in Chinese population~   "
121317|NCT01979536|"~     This partially randomized phase II trial studies how well brentuximab vedotin or crizotinib~     and combination chemotherapy works in treating patients with newly diagnosed stage II-IV~     anaplastic large cell lymphoma. Monoclonal antibody-drug conjugates, such as brentuximab~     vedotin, can block cancer growth in different ways by targeting certain cells. Crizotinib and~     methotrexate may stop the growth of cancer cells by blocking some of the enzymes needed for~     cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. It is not yet known whether brentuximab vedotin and combination chemotherapy is~     more effective than crizotinib and combination chemotherapy in treating anaplastic large cell~     lymphoma.~   "
121318|NCT01979523|"~     This randomized phase II trial studies how well trametinib with or without Akt inhibitor~     GSK2141795 (GSK2141795) works in treating patients with uveal melanoma that has spread to~     other parts of the body (metastatic). Trametinib and GSK2141795 may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. It is not yet known whether~     trametinib is more effective with or without GSK2141795 in treating patients with metastatic~     uveal melanoma.~   "
121319|NCT01979510|"~     The primary objective of this study is to evaluate the safety and tolerability of MK-0663B~     (etoricoxib/tizanidine) among participants with moderate-to-severe acute low back pain.~   "
121320|NCT01979497|"~     To determine whether the addition of adhesive stripping to a wound closed with dermal sutures~     improves outcome of wound closure. We hypothesize that the combination of adhesive strips to~     a wound closed with dermal sutures does not add significant cosmetic improvement of the~     resultant scar.~   "
121321|NCT01979484|"~     This study will compare the blood levels of PPI-668 resulting from two different formulations~     - the current capsule and a new tablet.~   "
121322|NCT01979471|"~     Cardiovascular disease (disease of the heart and blood vessels) is one of the leading causes~     of death in Canada. It also carries a financial burden on the Canadian economy with a yearly~     cost close to $21 billion divided between loss of productivity and healthcare costs. The~     majority of cardiovascular disease cases (90%) are caused by factors that can be controlled~     and modified. These factors include high blood pressure, high cholesterol, diabetes (high~     blood sugar), tobacco smoking, unhealthy diet, obesity, physical inactivity and high alcohol~     consumption. Such factors are very common and not very well controlled and so individuals who~     have any of these factors would be at risk of having cardiovascular disease. As such~     controlling these factors will reduce the risk of having cardiovascular disease and improve~     the individuals' quality of life. Pharmacists frequently work with patients and their family~     doctor to provide cardiovascular care. Having a pharmacist involved in cardiovascular care~     may help patients with cardiovascular disease or at risk of having the disease because they~     are more accessible and may have more opportunities to educate people about cardiovascular~     medications. This might lead to better prevention and control of cardiovascular disease.~      Purpose:~      The research study will assess if a community pharmacy cardiovascular risk reduction~     intervention can help reduce cardiovascular risk.~      Procedure:~      If the individual has an elevated blood pressure, cholesterol, blood sugar, waist~     circumference or body weight or is physically inactive, have an unhealthy diet, a smoker or~     taking medications for any of the previously mentioned conditions, the pharmacist will assess~     the cardiovascular disease risk [risk of having a cardiovascular event (e.g. heart attack or~     a stroke)] using a computer program. If the individual is at high risk s/he will be asked to~     take part in the study.~      If the individual agrees to take part in the study s/he will be randomly assigned to either~     the Usual Care Group or the Advanced Care Group. All participants have an equal chance of~     being assigned to either group. If assigned to the Usual Care Group, the individual will~     receive the care and services that would normally be provided by the pharmacist. At 3 months,~     the pharmacist will see the individual who will be offered the Advanced Care at that time.~      If assigned to the to Advanced Care Group, the individual will be asked to meet with the~     pharmacist every 3-4 weeks over a 3 month period. During these meetings, the pharmacist will~     conduct an assessment that may include blood pressure, waist circumference, height and weight~     measurements and talk to the individual about their cardiovascular risk and medications. The~     individual and the pharmacist will come up with a plan for how to try to lower his/her~     cardiovascular risk. The pharmacist will discuss this plan with their family doctor. The~     individual will be asked to conduct some laboratory tests before the 3 months visit; these~     tests may include HbA1c (a blood test to measure blood sugar control over the last 3 months)~     and cholesterol to assess the effect of the intervention on cardiovascular risk.~   "
121323|NCT01979458|"~     The goal of this research is to assess photometric stereo endoscopy (PSE) as an endoscopic~     imaging technique. Specifically, topographical surface contrast reconstructed from the PSE~     data will be compared to conventional imaging contrast to assess if PSE provides enhanced~     contrast of abnormal tissue.~   "
121324|NCT01979445|"~     There are two separate objectives in this study:~        1. To demonstrate the pharmacodynamic (PD) profile when participants treated with cangrelor~          are switched to oral prasugrel 60 mg administered 30 minutes (min) after cangrelor~          infusion is discontinued~        2. To demonstrate the PD profile when participants treated with cangrelor are switched to~          oral clopidogrel 600 mg administered during or immediately after cangrelor infusion.~   "
121325|NCT01979432|"~     The main objective of this study is to look for the interest forecast of the IPS as~     infra-clinical cardiovascular marker in the prediction of a change of the cognitive functions~     (MCI) at the elderly of 70 and more years old without clinical cardiovascular pathology.~   "
121326|NCT01979419|"~     PRIMARY OBJECTIVES~      -Establish a registry for Alzheimer's disease (AD) and subcortical ischemic vascular dementia~     (SIVD)~      STUDY DESIGN~      -This is a non-randomized, natural history, observational, registry study.~      SAMPLE SIZE AND RECRUITMENT~      - Five hundred subjects will be enrolled at each clinical site (50 NC, 200 with MCI, 50 with~     AD, 100 with vMCI, and 100 with SIVD)~      SUMMARY OF KEY ELIGIBILITY CRITERIA~        -  Newly enrolled subjects will be between 50-80 (inclusive) years of age.~        -  1) Cognitively Normal Subjects~        -  2) MCI subjects~        -  3) AD subjects~        -  4) vMCI or SIVD~      PROCEDURES~        -  Recruited subjects will have clinical/cognitive assessments, biomarker and genetic~          sample collection, and imaging.~        -  Subjects will be followed up for 36 months from the baseline visit. All assessments are~          to be performed every year from baseline(0, 12, 24, 36 months), except; 1) FDG-PET and~          amyloid-PET will be performed every two years, i.e., on baseline and at 24 month visit.~          2) CSF collection will also be performed on baseline and at 24 months visit. 3)~          Clinical/cognitive assessment and MRI evaluation will additionally be done at 6 months~          from baseline to determine short term change.~      OUTCOME MEASURES~        -  Group differences for each clinical, cognitive, biochemical, and imaging measurement.~        -  Rate of conversion or change of disease severity will be evaluated among all groups~        -  Correlations among biomarkers and biomarker changes~   "
121327|NCT01979406|"~     The purpose of this study is to evaluate 2 vaccine candidates against anthrax compared to the~     positive (vaccine) control as studied in normal healthy volunteers.~   "
121328|NCT01979393|"~     This study aims to investigate a drug called Cabozantinib which belongs to a family of drugs~     that have effects on tumour growth, blood supply, invasion and spread.~      Therefore, we want to find out whether taking cabozantinib after treatment with surgery and~     chemotherapy is effective and safe for patients who responded or had stable disease after~     their chemotherapy.~      All participants will receive 4-6 cycles of standard chemotherapy. Those with stabilization~     or response to the standard chemotherapy will be split into 2 groups (cabozantinib or~     placebo).~   "
121329|NCT01979380|"~     To Evaluate the safety and tolerability after KD101 single oral dosing in healthy male~     subjects~      To Evaluate the pharmacokinetic property after KD101 single oral dosing in healthy male~     subjects~      To Evaluate the effect of food on bioavailability after KD101 single oral dosing in healthy~     male subjects~   "
121330|NCT01979367|"~     Physician Clinical Trial Policy (CTP) to evaluate the efficacy treatment of lower extremity~     pathologies derived from neurological ischemia disorders using the combination of~     Monochromatic Infrared Photo Energy (MIRE) and Transcutaneous Electrical Nerve Stimulation~     (TENS) therapies.~   "
121331|NCT01979354|"~     Postoperative pain after Video-assisted Thoracoscopic Surgery (VAT) is still debating.~     Therefore the investigators conduct a study comparing 0.15 mg spinal morphine and control~     group in term of analgesia.~   "
121332|NCT01979341|"~     The use of antagonist controlled ovarian stimulation protocols has allowed the use of GnRH~     agonist to be used for final oocyte maturation. The use of GnRH agonist as ovulation trigger~     has been shown to reduce the risks for ovarian hyperstimulation syndrome (OHSS), but its sole~     use results in reduced embryo implantation due to luteal phase insufficiency. The combination~     of GnRH agonist and variable doses of hCG for final oocyte maturation has been shown to~     overcome the luteal phase insufficiency effecting endometrial receptivity.~      In this study the investigators will test the hypothesis that using GnRH agonist (0.2mg~     Triptorelin) and a full dose of hCG (6500IU Ovitrelle) for final oocyte maturation in~     normoresponders will increase oocyte maturity, embryo quality and embryo implantation and~     reduce ovarian hyperstimulation syndrome, as compared to the traditional hCG (full dose)~     alone trigger.~   "
121333|NCT01979328|"~     The primary objective of this study is to examine the flow characteristics of deep venous~     flow in the leg veins using Doppler ultrasound imaging and how this flow is modified by the~     application of a plaster and with a geko™ device in healthy volunteers~   "
121334|NCT01979315|"~     Diagnostic and prognostic value of pain hypersensitivity in low back pain (LBP) is not fully~     understood.Increased pain sensitivity in the primary area of pain (local pain) is considered~     a sign of predominantly peripheral pain sensitization,value of pain hypersensitivity in low~     back pain (LBP)is not fully understood whereas pain sensitivity in distal and remote areas is~     considered to present a more central phenomenon. It is suggested that pat ents with enhanced~     pain sensitivity report high level of disability. Despite fact that pain and disability are~     associated in chronic LBP the exact mechanisms of sensitivity contribution in LBP disability~     is unknown. It has also been suggested that muscle function changes may be driven by pain.~     The possible role and contribution of trunk muscles function to pain and disability phenomena~     remain unknown.~      This study was aimed to estimate prevalence and possible correlation among pain~     hypersensitivity and functional and electromyography parameters of trunk muscles in patients~     reporting early phase of chronic LBP.~   "
121335|NCT01979302|"~     Depression in older home healthcare patients occurs very often, is typically not treated~     appropriately, and leads to poor health outcomes. This study tests an intervention, called~     Depression Care for Patients at Home or the Depression CAREPATH, designed to help home~     healthcare nurses work with the patients, their family, and their doctors in managing~     depression treat depression according to clinical guidelines and to manage its treatment over~     time. Patient outcomes, measured at 3, 6, and 12 months, include guideline-consistent changes~     in depression treatment and reduction in depressive symptoms.~   "
122061|NCT01969799|"~     To demonstrate the safety and efficacy of adjunctive therapy with the Amikacin fosfomycin~     inhalation system (AFIS) versus aerosolized placebo to treat Gram-negative pneumonia in~     mechanically ventilated patients receiving IV antibiotics.~   "
121336|NCT01979289|"~     This research study will examine if a targeted computerized cognitive remediation (CCR)~     training program is better for treating geriatric depression than general computer activity.~     We will also examine whether this intervention is related to improvement in cognitive and~     depressive symptoms. Elderly patients with depression, who have, and who have not been~     treated with antidepressant medication for their illness, will be recruited to participate in~     either a 30 hour cognitive remediation program or general computer activity designed to be~     both challenging and interesting. They will be asked to complete between 1 and 3 hours of~     remediation per day over 4 weeks. While undergoing the cognitive remediation participants~     will be asked questions to assess their symptoms of, as well as the severity of, their~     depression weekly. This will inform researchers about whether or not the CCR is helping to~     improve depressive symptoms. At the end of the CCR study, participants will be given a~     battery of cognitive tests design to tell investigators whether or not the CCR improved their~     thinking in a variety of different ways including improving attention, memory, and~     organization. Investigators will also determine whether changes in participants' thinking are~     related to changes in their mood or other depressive symptoms. It is hoped that information~     gained from this study will help investigators to better understand the brain processes~     associated with depression, recovery from depression, and will help inform the development of~     future alternative treatments for this illness.~   "
121337|NCT01979276|"~     This clinical trial is for subjects with multiple myeloma that has returned after treatment~     (relapsed) or did not respond to prior treatment (refractory). The study is in two parts,~     Phase I and Phase II. Phase I will determine the maximum tolerated dose of romidepsin in~     combination with pomalidomide and dexamethasone. The purpose of Phase II is to evaluate the~     effectiveness of combining romidepsin with pomalidomide and dexamethasone. The hypothesis is~     that overall response in a cohort of patients treated with romidepsin + pomalidomide +~     dexamethasone will be 60 percent.~   "
121338|NCT01979263|"~     The purpose of this project is to study the feasibility and efficacy of attention bias~     modification treatment (ABMT) in a randomized-controlled sample of anxious youth.~   "
121339|NCT01979250|"~     Background Fuchs' Endothelial Dystrophy Fuchs' Endothelial Dystrophy (Fuchs' ED) is~     characterized by changes on the inside of the cornea, which leads to a substantial decline in~     visual acuity. The only effective treatment option for Fuchs' ED is corneal transplantation.~      Corneal transplantation Corneal transplantation surgery has seen major advances in the last~     decade, and the Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK) procedure has~     now become the preferred method.~      Outcome There have been a substantial number of publications on outcome after DSAEK surgery,~     and the procedure has several advantages over the former preferred method of transplantation,~     penetrating keratoplasty (PK).~      Despite the apparent success of the DSAEK procedure, visual acuity is seldom fully restored~     even in otherwise healthy eyes. Several studies have tried to clarify this matter but so far~     results have been conflicting.~      Hypotheses~        1. The reduction in visual acuity and contrast sensitivity in patients with Fuchs'~          endothelial dystrophy is correlated with corneal thickness, corneal light scatter, and~          the type and magnitude of optical disrupting guttae in Descemet's membrane.~        2. The subjective visual function after corneal transplantation with a posterior lamellar~          graft is correlated with the optical properties of the grafted cornea (thickness, light~          scatter, irregularities on the anterior, and posterior corneal surfaces)~      Materials and methods~      In a controlled prospective trial of DSAEK patients, we aim to register different~     morphological patterns, monitor visual performance and optical parameters.~      Three sex and age-matched groups will be compared:~      Group 1: 40 patients that undergo DSAEK surgery Group 2: 40 patients that undergo combined~     cataract and DSAEK surgery. Group 3: Control group of 40 patients with normal corneas that~     undergo cataract surgery.~   "
121340|NCT01979237|"~     Shoulder anterior dislocation is a major disease entity in emergency department. There are~     more than 10 reduction methods that have been reported. Traditional reduction methods require~     sedatives, which could cause adverse effects on the patients such as respiratory suppression~     and allergy. There are some reduction maneuvers reported recently which do not need sedatives~     prior to performing reduction, including FARES method and SPASO method. So far, there are no~     well-designed study to compare these two methods. Besides, in clinical experience, we found~     that combining these two methods could even get higher successful reduction rate. This study~     is aimed to compare these two methods as a prospective randomized design, and furthermore, to~     show that combining these two methods could get higher successful reduction rate.~   "
121341|NCT01979224|"~     Introduction. Asthma is a chronic inflammatory disorder of the airways, identified by airflow~     obstruction. Unfortunately only 2.4% of American asthmatics meet internationally recommended~     criteria for control. The lack of knowledge in parents of asthmatic children has been a~     direct result of minimum or no control at all, so the educational programs need to be~     assessed in terms of improvement of the control. Target. To determine whether an educational~     intervention aimed at parents of asthmatic children 4 to 11 years improved clinical control~     measured by Test Childhood Asthma Control. Material and Methods. Randomized controlled~     clinical trial in 42 patients randomly divided into two groups that were evaluated in the~     same time knowledge and control of asthma, a measurement was performed at baseline and~     monthly for nine months. The experimental group attended an educational intervention for~     individual reinforcements through this period, the control group was only monitored~   "
121342|NCT01979211|"~     The standard treatment of surgery followed by radiation therapy can stop tumors from growing~     in the head and neck region in most patients. However, the cancer can recur or can spread to~     other parts of the body. Cetuximab is a drug that may delay or prevent tumor growth by~     blocking certain cellular chemical pathways that lead to tumor development. It was approved~     by the United States Food and Drug Administration (FDA) in 2006 for the treatment of head and~     neck cancer.~      The purpose of this study is to determine how easily cetuximab can be added to treatment with~     radiation therapy in patients with cutaneous cancer of the head and neck. This study will~     also look at how well cetuximab added to radiation therapy works over time and how well this~     treatment is tolerated.~   "
121343|NCT01979198|"~     The surgical results of thoracolumbar and lumbar burst fracture have been reported to be~     comparable between patients with and without fusion in a midterm follow-up. There is,~     however, no report comparing the results of fusion and non-fusion with a long-term follow-up.~     Therefore, a long term comparative study is still needed to focus on the issues of functional~     and radiographic outcomes, especially preservation of the motion segment in the long run, to~     determine whether fusion should be a routine procedure for surgically treated burst fractures~     of the thoracolumbar and lumbar spines. Therefore, we report herein a long-term comparative~     study of fusion and non-fusion based on our previous work, with an average 134 months of~     follow-up.~   "
121344|NCT01979185|"~     This is a randomized, open-label study to evaluate the effect of a single dose of SSP-004184~     on the pharmacokinetics of a single dose of simvastatin in healthy adult subjects.~   "
121346|NCT01979159|"~     In order to determine if speech-language therapy has positive effect, reliable measurement~     tools are required to document outcomes. Currently, there is very limited information~     concerning the measurement of changes in speech production as a result of treatment for~     acquired apraxia of speech and aphasia. This study will obtain information concerning the~     reliability of several speech production measures over time. Thirty persons with chronic~     aphasia and apraxia of speech will be asked to provide speech samples in response to commonly~     used assessment tools on three sampling occasions so that the stability of measurements may~     be examined.~      After establishment of appropriate outcome measures, a small, pilot treatment study will be~     conducted with four participants. The participants will receive a new treatment for aphasia~     and acquired apraxia of speech and outcomes will be measured relative to speech and language~     production.~   "
121347|NCT01979146|"~     The purpose of this study was to test the efficacy of a computer-based automated symptom~     monitoring telephone system used by patients who received chemotherapy for their cancer to~     communicate unrelieved symptoms they experienced to their oncology providers.~   "
121348|NCT01979133|"~     This study is being done to see if icariin will help with depression in patients with bipolar~     disorder and alcohol or cocaine use disorders. The pills used in this study contain 20%~     icariin.~   "
121349|NCT01979120|"~     A prospective observational multi-centre study for the validation of the ApneaScan algorithm~     (integrated in ICD devices (with or without cardiac resynchronization therapy function) of~     the Incepta series for the screening of sleep disordered breathing in patients with stable~     symptomatic chronic heart failure, using portable polygraphy monitoring device (Embletta~     Gold) as reference for the Apnea-Hypopnea-Index (AHI).~      Secondary objectives are the detection of severe sleep disordered breathing in patients with~     clinically indicated in-laboratory polysomnography, as well as correlations of the AHI~     detected by ApneaScan with other clinical endpoints like mortality, hospitalization, atrial~     fibrillation and ventricular arrhythmia.~   "
121350|NCT01979107|"~     In this randomized controlled study it is investigated if a proactive action by the general~     practitioner offering individuals without formal education a preventive health check will~     lead to a larger number of diagnoses in form of chronic obstructive pulmonary disease,~     cardiovascular diseases, and diabetes among participants in the intervention group compared~     to the control group. Furthermore it will be investigated if the proactive action by the~     general practitioner will be associated with a higher smoking cessation rate at 12 month~     follow-up.~   "
121351|NCT01979094|"~     To collect and organize data into a repository for future research.~   "
121352|NCT01979081|"~     The Physical Functioning Inventory (PFI) is a standardized patient reported outcome measure~     that assesses preclinical disability. Preclinical disability is a functional state in which~     people are still able to complete daily living tasks (e.g., walking, bathing) but are~     changing the frequency or modifying the way that they complete the tasks. The investigators~     have done some preliminary research using the PFI as an online monitoring tool (Richardson~     2012), but further study is required to examine its psychometric properties and its~     suitability for use as a primary outcome measure. This measurement study has been designed to~     identify the optimal number of items on the PFI and to determine the reliability, validity,~     and responsiveness of the PFI when administered to a sample of adults and older adults both~     with and without chronic conditions. This project will also allow us to evaluate the use of~     self-monitoring of physical function and the added value of rehabilitation professionals to~     support self-monitoring. Using the results of the PFI, the investigators aim to develop a~     tailored population-based rehabilitation self-management intervention delivered through a~     secure messaging system in the patient's electronic personal health record (myOSCAR) that~     focuses on the early detection and prevention of preclinical disability.~   "
121353|NCT01979068|"~     -  Vascular Inflammation is a key factor in both the pathogenesis and outcome of~          atherosclerosis. 18FDG-PET is a promising novel tool for identifying and quantifying~          vascular inflammation within atherosclerotic plaque~        -  Recently, unique subsets of obese individuals, such as metabolically obese but normal~          weight (MONW) and metabolically healthy obese (MHO), have been getting an attention~        -  Therefore, the purpose of this study is to examine the relationship of vascular~          inflammation,measured by FDG-PET, with various body sized phenotypes~   "
121354|NCT01979055|"~     Asthma in older adults has been overlooked, understudied, and inadequately treated. While~     asthma programs targeting the unique needs of children, teenagers, women, minorities, and~     other populations have been successfully developed, there are currently none for older~     adults. This is particularly distressing as the asthma hospitalization rates, mortality~     rates, quality of life, and control are significantly worse in the elderly as compared to~     other age groups. It is clear that novel approaches are needed to improve the care in this~     population.~      The investigators group has been active in the research of asthma in the elderly. The~     investigators have analyzed national asthma data sets to look for disparities in older~     adults, have conducted qualitative research to determine factors associated with poor control~     in the elderly, and have performed a pilot study of a self-regulation intervention which was~     able to improve outcomes. The investigators also have over 20 years of experience in asthma~     self-regulation interventions and physician communication enhancement for multiple~     populations of asthma patients. The investigators will combine these strengths into their~     current protocol.~      The intervention program will be based on the self-regulation theory of behavior, which will~     enhance the participants' ability to self-manage this chronic condition, actively involve the~     participant in their own health care management, and produce sustained results. In this~     proposal, the investigators will evaluate a self-regulation asthma intervention in a diverse~     population of older adults. The intervention will be personalized to the challenges and goals~     each individual faces, which will enhance its applicability in different populations. This~     intervention will incorporate standard asthma education, complementary techniques for which~     older adults have expressed a strong interest, and enhanced communication with each~     participant's physician. Asthma specific outcomes will be assessed at 1, 6, and 12 months.~     The primary goal of this intervention is to decrease health care utilization (emergency~     department, urgent care, hospital, and unscheduled visits) for older adults with asthma. The~     investigators will also assess the ability to improve quality of life, asthma symptoms,~     asthma control, lung function parameters, self-efficacy, and cost effectiveness.~   "
121355|NCT01979042|"~     Renal colic is usually caused from an obstructing stone along the ureter. Some of the~     patients present with a high level of creatinin in the blood, even though there is a normal~     functioning contralateral kidney. Furthermore creatinin is not an ideal marker for renal~     function during acute changes.~      Several works have shown that modern urinary markers such as NGAL (neutrophil~     gelatinase-associated lipocalin), KIM-1 (Kidney Injury Molecule-1) and others rise earlier~     and are much more sensitive for kidney insult. There is a lack of research on their role in~     acute kidney obstruction~   "
122062|NCT01969786|"~     VIEW is a community-randomized trial designed to determine whether it is possible to prevent~     corneal ulcers on a large scale. The study compares the incidence of corneal ulceration~     between villages in which volunteers are trained to diagnose and treat corneal abrasions and~     villages which receive no intervention.~   "
121359|NCT01978990|"~     Modern medicine provides many solutions that are intended to help control the patient's blood~     glucose level: insulin and other medications to lower it, glucose tablets or glucagone to~     raise it when it gets dangerously low, glucometers to quickly measure the blood glucose~     level, pumps and pens to inject insulin or other injectable medicine, etc.The objective of~     this trial is proving the concept and the feasibility of using a medical informatics system~     comprised of computer hardware, software and a smartphone application to achieve better~     outcomes.~   "
121360|NCT01978977|"~     Investigators propose to assess,the safety and tolerability profile (number of participants~     with adverse events)of bevacizumab (Avastin) when combined with standard chemotherapy as~     first line treatment of patients with metastatic Breast Cancer.~   "
121361|NCT01978964|"~     This is an open label phase 1b maintenance therapy study to evaluate the long-term safety,~     immunogenicity, and anti-tumor effects of repeat-dose vaccination with ONT-10 in patients who~     have demonstrated safety and clinical benefit on the original ONT-10-001 phase 1 study.~   "
121362|NCT01978951|"~     If primary health-care officers and Villages Health Volunteers (VHVs) be trained to render~     proper CKD care, it is interesting if their intimate relationship and commitment to their~     responsible village households will result in better outcomes when compared with the~     conventional care model as mention above. In this project, we plan to compare the~     effectiveness of a conventional care program against an integrated multidisciplinary CKD care~     program provided by nephrologists in conjunction with well-trained paramedical personnel and~     VHVs on CKD progression.~   "
121363|NCT01978938|"~     This is a Phase 3, Randomized, Double-Blind, Double-Dummy, Multicenter, Prospective Study to~     Assess the Efficacy and Safety of Eravacycline Compared with Levofloxacin in Complicated~     Urinary Tract Infections (cUTI)~   "
121364|NCT01978925|"~     The purpose of this study is to evaluate the effectiveness of pharmaceutical care, compared~     to usual care, in patient discharge in an emergency department in patients with hypertension~     and/or diabetes mellitus type 2.~   "
121365|NCT01978912|"~     The purpose of this study is to evaluate the safety and exploratory efficacy of KTP-001 in~     subjects with lumbar disc herniation.~   "
121366|NCT01978899|"~     Studies have shown that patients who weigh more at the time of cancer diagnosis may be at~     increased risk of complications from surgery, fatigue, poor body image and other problems.~     Some research suggests that losing weight after cancer diagnosis can lead to improvements in~     these problems, as well as having other potential benefits for cancer survivors. Programs~     that reduce calories and increase exercise have been shown to help cancer survivors lose~     weight, but more research is needed to develop and test weight loss programs in cancer~     survivors.~      This study is designed to look at the ability of a 15-week diet and exercise program to help~     cancer survivors lose weight. The investigator will look at changes in weight, body~     composition, quality of life, fatigue, body image as well as diet and exercise patterns, to~     see if this program can help men and women feel better and live healthier lives after cancer~     diagnosis.~   "
121367|NCT01978886|"~     The purpose of the study is to investigate how high the prevalence of diabetes (known and~     unknown) is among patients with a frozen shoulder. Our hypothesis is that it is around 30-40~     %.~      Another purpose is to investigate whether patients with diabetes have a worse and more~     painful frozen shoulder than patients without diabetes, and whether the diabetes have an~     influence on the prognosis.~   "
121368|NCT01978873|"~     This clinical trial is designed on the basis of an unmet clinical need, as well as other~     factors including: 1) the ability to identify subjects at high risk of dying early from their~     disease, 2) the fact that hormonal therapy has already been shown to improve survival when~     applied early in the natural history, 3) the availability of chemotherapy such as cabazitaxel~     that can improve survival in subjects with advanced disease and 4) that chemotherapy~     (docetaxel) given concomitant with hormone treatment has proven to prolong time to~     progression.~      It is the investigators hypothesis that a more appropriate group of patients who may benefit~     from the curative potential of systemic chemo-hormonal modality is that with minimal, but~     detectable disease who have a high probability of developing metastatic disease, clinical~     symptoms and eventually death from prostate cancer in a defined time frame. The investigators~     hypothesize further that the approach is likely to be more effective at a time of minimal~     tumour burden, resulting in minimization of the overall burden of therapy and better quality~     of life while on treatment.~      This trial will determine whether any benefit is gained by adding chemotherapy before~     hormonal therapy to hormonal therapy alone in the population of subjects with metastatic or~     high risk disease.~   "
121369|NCT01978860|"~     This is a prospective, non-randomized, first-in-man investigational study, to assess the~     safety and technical feasibility, deployment and withdrawal characteristics of the NovaCross™~     micro-catheter during an interventional coronary angioplasty procedure and evaluating the CTO~     penetration rate.~      Each study subject/patient will have a total of one (1) procedure performed for this study.~   "
121370|NCT01978847|"~     Retrospective review will allow for an evaluation of potential patient- or procedure-related~     factors that are associated with the development of either radiologic or clinical~     adjacent-segment pathology.~   "
121379|NCT01978730|"~     As a traditional Chinese medicine compound, SaiLuoTong capsule is proven to have beneficial~     effects on learning and memory ability in animal models of vascular dementia (VaD). The study~     hypothesis is that SaiLuoTong capsule will be effective in the treatment of patients with VaD~     and will be well tolerated. The purpose of the study is to determine the efficacy and safety~     of SaiLuoTong capsule on patients with mild to moderate VaD. The outcome measures include~     general cognitive function, executive function, daily living skills, and mental behavior~     changes of symptoms in VaD patients.~   "
121380|NCT01978717|"~     The purpose of this study is to prove whether general anesthesia combined with epidural~     anesthesia could better maintain body balance of Th1/Th2 and Treg/Th17 compared with general~     anesthesia, so as to reduce the surgical stress-related immunosuppression, and to improve the~     prognosis.~   "
121381|NCT01978704|"~     The aim of this study is to compare the feasibility and the efficacy on short-term glucose~     control of pre-meal insulin doses adjustment made on the bases of the glycemic load or of the~     carbohydrates content of the meal in patients with type 1 diabetes mellitus treated with~     insulin pump~   "
121371|NCT01978834|"~     This study is designed for clinical validation of the novel ultrasound device (Bindex®, Bone~     Index Finland Ltd.). In a preliminary study technique has been validated in Finnish elderly~     woman population with 285 healthy and 56 osteoporotic subjects (n = 341 in total).~     Significant and good correlation was observed between Density Index (DI) determined with~     Bindex and femoral bone mineral density determined with DXA (r = 0.65 - 0.70). In addition,~     with determination of 90% sensitivity and specificity thresholds, significant number (65-75%)~     of patients could be diagnosed without additional verification with DXA.~      First, the thresholds for DI will be determined by measuring 70 osteoporotic and 70 healthy~     patients (n = 140) with Bindex and DXA within four decades of age; age 50 to 59 years, age 60~     to 69 years, age 70 to 79 years, and age 80 to 89 years. The feasibility of DI for~     diagnostics of osteoporosis and evaluation of bone mineral density (BMD) will be assessed.~     The thresholds for the BMD estimate obtained with DI will be determined for osteoporotic and~     non-osteoporotic patients. For fracture risk assessment, DI measurements are used to predict~     the outcome of currently available fracture risk assessment tools.~        1. To investigate optimal configuration of ultrasound parameters and patient~          characteristics for prediction of proximal femur and lumbar spine BMD for women in each~          four decades of age; 50 to 59 years, 60 to 69 years, 70 to 79 years, and 80-89 years.~        2. To develop national diagnostic thresholds for DI in prediction of osteoporosis status~          with a reference female population (American-Caucasian) in each four decades of age; 50~          to 59 years, 60 to 69 years, 70 to 79 years, and 80-89 years.~   "
121372|NCT01978821|"~     the purpose of this study was to study the effect of stem cell therapy on common symptoms of~     cerebral palsy patients.~   "
121373|NCT01978808|"~     For diagnosis of pancreatic tumors, endoscopic ultrasound (EUS) and EUS-guided fine needle~     aspiration (EUS-FNA) are well established techniques in clinical practice. We hypothesize~     that a FNA needle with a side port could improve the diagnostic yield. The aim of this~     prospective randomized study is to determine whether there is a difference in diagnostic~     yield in patients with pancreatic masses for evaluation.~   "
121374|NCT01978795|"~     This study evaluated Brain 101: The Concussion Play book, an intervention that provides~     education and resources on concussion management for high schools. The study hypotheses were~     that athletes and parents who viewed the Brain 101 program would demonstrate increased~     knowledge and self efficacy in concussion management, and that use of the intervention would~     positively affect school concussion management practices.~   "
121375|NCT01978782|"~     Depression is the most common mental health disorder among HIV-patients. Recognizing and~     treating depression is important in order to improve quality of life and health outcomes in~     those living with HIV. In clinical practice selective serotonin reuptake inhibitors (SSRIs)~     are used most frequently in HIV patients with depressive symptoms. A complicating factor in~     the concomitant use of antiretroviral agents and antidepressant therapy is the occurrence of~     drug-drug interactions. Citalopram can be seen as one of the preferred SSRIs in HIV-infected~     patients because citalopram has a relatively favourable drug interaction profile compared to~     other SSRIs. Raltegravir is an HIV-1 integrase inhibitor and is frequently being used as~     antiretroviral agent in combination with tenofovir/emtricitabine in HIV-patients. Raltegravir~     has shown sustained antiretroviral activity, is generally well tolerated and has little~     propensity to interact with other drugs because it does not inhibit or induce CYP450 enzymes.~     Theoretically, no clinically relevant drug interaction is expected between raltegravir and~     citalopram as raltegravir is not a CYP2D6 substrate and thus will not be affected by the~     possible inhibition of CYP2D6 by citalopram. Raltegravir is metabolized by UGT but citalopram~     is not known to influence UGT. A possible interaction may occur through inhibition of P-gp~     mediated transport of raltegravir by citalopram. However, even when no drug interaction is~     expected theoretically, it may be recommended to collect sufficient clinical evidence to~     support this hypothesis because unexpected interactions with raltegravir have been observed~     in the past. In order to be able to recommend raltegravir and citalopram concomitant use, a~     pharmacokinetic study in healthy volunteers is proposed.~   "
121376|NCT01978769|"~     In the current study we will examine a specific aspect of these processes that has yet to be~     studied. We will test the effect that a physically effortful assignment has on the choices~     that a preadolescent makes using a forced choice paradigm in which the participant will be~     asked to choose between and carry out either a high cost-high reward option (HR) or a low~     cost-low reward (LR) option. The HR option will demand a significant amount of physical~     effort and will be paired up with a large reward as opposed to the LR option which will be~     less demanding physically and paired up with a small reward. The assignment will be carried~     out using a hand held dynamometer which measures the power produced by the participants'~     upper extremity.~      We propose that a child with attention deficit hyperactivity disorder (ADHD) will choose a~     task that involves less effort despite the small reward tied to it compared to a control~     child who will choose the more demanding task and the larger reward.~   "
121377|NCT01978756|"~     In order to evaluate the late outcome in patients curatively treated for breast cancer, a~     special outpatient clinic will be developed.~      There are two main purposes of the outpatient clinic. The first purpose is evaluating the~     results of the radiation treatment by mapping A) late toxicity and B) tumour control and~     survival.~      The second purpose is that this outpatient clinic for late outcome will also function as a~     pilot for a new CAT (Computer Assisted Theragnostics, abbreviated CAT project) in which~     multiple late outcome variables will be recorded. In this pilot we want to investigate~     whether physical presence of the patient on the outpatient clinic, allowing physical~     examination, has any added value to the questionnaires filled in by the patient at home.~      The ultimate aim of this new CAT project is to use these multicentric data to develop models~     for predicting both oncological outcome and late side effects. Insight in the beneficial and~     adverse effects of a certain treatment using these predictive models, will be required choose~     the optimal treatment for the individual patient using a shared decision making process.~   "
121378|NCT01978743|"~     In this study investigators will use a multi-modal imaging approach of MRS and fMRI to~     comprehensively assess the biological changes in the brain associated with EFV-based regimen~     (EFV/FTC/TDF), specifically alterations in the brain circuitry, function and local~     neurochemistry, and their correlation with neuropsychological function.~   "
121382|NCT01978691|"~     Obesity is a major problem worldwide, and it is related to abnormalities in glucose and lipid~     metabolism. The purpose of this study is to investigate the effect of a dietary supplement~     containing probiotic (Bifidobacterium animalis ssp. lactis 420) and/or prebiotic (Litesse) on~     change in body fat mass in a double-blind, randomized, placebo-controlled intervention trial.~     The supplement is ingested once per day for the duration of six months, and participants will~     attend a follow-up visit one month after the end of the intervention. The study will enroll~     232 participants (58 per study arm) in four research centers in southern Finland.~   "
121383|NCT01978678|"~     The application of biomarkers that are more closely associated with eosinophillic airway~     inflammation, such as measurements of FeNO level, cell count in induced sputum or bronchial~     reactivity could improve asthma control by better directing treatment. A systematic review~     and meta-analysis is to be conducted to assess the efficacy of tailoring asthma intervention~     on clinical symptoms compared with exhaled nitric oxide or induced sputum count.~   "
121384|NCT01978665|"~     The objective of this study is to investigate if there is an effect on exercise performance~     og of the anti inflammatory drugs prednisone and solu-medrol in patints with chronic~     obstructive pulmonary disease(COPD)~   "
121385|NCT01978652|"~     The primary objective of this study is to characterise the pharmacokinetics (PK) of BIIB017~     (Peginterferon Beta-1a) administered as a single 125 μg subcutaneous (SC) dose in Japanese~     and Caucasian adult healthy participants. The secondary Objective is to assess the safety and~     tolerability of a single 125 μg subcutaneous (SC) dose of BIIB017 in Japanese and Caucasian~     adult healthy participants.~   "
121386|NCT01978639|"~     This study will assess the outcomes of three currently available regenerative treatments~     (FloGraft, autologous stem cell therapy, platelet rich plasma therapy) for painful~     degenerative conditions of the joints. Patients receiving one these treatments will be~     assessed before the treatment procedure and followed up at four points over the six months~     after their procedure. Patients' pain, quality of life, and pain medication use at follow up~     will be compared to baseline levels. The investigators hypothesize that all three treatments~     will be effective in reducing pain, improving quality of life, and reducing pain medication~     usage.~   "
121387|NCT01978626|"~     Cognitive Behavioral Therapy for Insomnia (CBT-I) has been proven as an effective~     intervention for the non-pharmacological treatment of insomnia. This study hypothesizes app~     programs of smart phone would enhance the compliance and performance of behavioral~     intervention of CBT-I. During a 3-year study period, 3 app modules, including electronic~     sleep diary along with message reminder system, social persuasion system and Tai-Chi practice~     system will be tested subsequently for their efficacy.~   "
121388|NCT01978613|"~     This trial is conducted in Europe. The aim of the trial is to investigate safety,~     tolerability and pharmacokinetics (the exposure of the trial drug in the body) of multiple~     doses of NNC0113-0987 in an oral formulation in healthy subjects.~   "
121389|NCT01978600|"~     The purpose of this study is to evaluate intraocular pressure (IOP) over a 24-hour period~     using Simbrinza™ topical ophthalmic suspension.~   "
121390|NCT01978587|"~     The purpose of this study is to evaluate the effect of hemodialysis on the pharmacokinetics~     (PK) of JTZ-951 and to evaluate the safety of 2 doses of JTZ-951 in subjects with end-stage~     renal disease (ESRD) receiving hemodialysis~   "
121391|NCT01978574|"~     Cognitive problems are a primary concern for people with multiple sclerosis. In many cases,~     people with MS report these issues to be more debilitating than the motor symptoms that are~     targeted by most treatment strategies. For people with MS, impaired memory and thinking~     skills can interfere with the ability to function efficiently in multiple professional and~     personal roles. Finding ways to decrease, slow, or reverse declines in memory and thinking~     skills is a vitally important research priority. We now know that engaging in intellectually~     enriching activities helps protect against the negative impact of MS disease-related declines~     in memory and thinking. Such activities contribute to something called 'cognitive reserve,'~     which serves as a protection against disease-related declines in memory and thinking. Thus~     far, no one has created a treatment that aims to provide a concentrated 'dose' of~     intellectual enrichment to build cognitive reserve. The present intervention aims to do~     precisely this. Here, we have developed a program of enriching activities that are delivered~     via a personal iPad. This allows for a 12-week 'treatment' that is entirely home-based, while~     also providing close personal contact between participants and our study personnel, who will~     communicate daily via emails. Week by week, participants choose from a menu of intellectually~     enriching activities such that their treatment is dynamic and customizable to fit their~     interests. The intervention is designed to be fun, as we hope the activities will be~     incorporated into people's lives beyond the period of the study itself. Given what we already~     know about the striking benefits of cognitive reserve to protect against disease-related~     declines in cognitive functioning, we expect to show that treatment with a daily, intense,~     intellectually enriching schedule of activities results in improved thinking and memory for~     people with MS. We will also investigate the positive impact of our treatment on the brains~     of people with MS through brain scans. We expect to see evidence for a shift toward more~     efficient processing in the brain, changes that translate to improved memory and thinking~     skills.~   "
121392|NCT01978561|"~     The purpose of this study is to evaluate pregnancy, delivery, and neonatal outcomes in~     subjects who maintain ongoing clinical pregnancies through Week 10 of gestation in NT-03.~   "
121393|NCT01978548|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and~     pharmacodynamics of JNJ-54861911 in patients with prodromal Alzheimer's disease (pAD).~   "
121394|NCT01978535|"~     This study is designed to investigate whether the treatment of non-anemic iron deficiency~     with intervenous iron sucrose will result in decreased symptom reporting and improved~     cardiovascular indices in adolescents (age 12-21) with Postural Orthostatic Tachycardia~     Syndrome (POTS).~   "
121405|NCT01978392|"~     The specific aim of the study is to evaluate the health benefits of a series of group~     workshops designed for workers with chronic physical health conditions. The facilitated~     workshops apply principles of pain and illness self-management to help workers deal with~     health-related challenges while at work. The workshops address issues of pain management,~     physical job demands, pacing of work, communication, problem solving, and coping. Half of the~     participants in the study will be randomly assigned to attend workshop sessions (10 hours~     total), and all study participants will be followed for one year. The primary hypothesis is~     that workers who participate in these workshops will show improvements in work engagement and~     reductions in work limitation in the subsequent 12 months.~   "
121430|NCT01978054|"~     The purpose of this study is to identify and evaluate dissemination strategies to promote the~     uptake of evidence-based cancer and other chronic disease prevention among state-level public~     health practitioners. Dissemination strategies such as multi-day in-person training workshops~     and electronic information exchange modalities are hypothesized to associate with improved~     access and use of public health evidence and organizational supports for program and policy~     decision making based on evidence-based public health.~   "
121395|NCT01978522|"~     Recruiting, retaining and gathering complete data on participants in research projects, be~     they patients or health professionals, can be extremely difficult. These problems increase~     the risk that research will be abandoned before its true value is appreciated, or lead to~     delays in resolving uncertainty for decision makers, while further studies are done. Poor~     recruitment, retention and outcome collection frequently lead to many prospective studies~     being extended, increasing costs. Researchers need to use strategies that are themselves~     evidence-based. This study proposes to link with an existing longitudinal ageing study called~     NICOLA to provide evidence on what research participants prefer in relation to providing~     personal information through a self-completed questionnaire. NICOLA is a large study of~     people over the age of 50 that is being conducted in Northern Ireland. NICOLA is aiming to~     recruit 8500 people and will ask them questions about participation in social activities,~     including organised structured and informal activities; relationship quality; loneliness;~     stress; resilience; quality of life; alcohol intake; food poverty and assess their health and~     wellbeing. Participants in NICOLA agree to having an interviewer visit them at home to ask~     questions about their lives, complete questionnaires in their own time and attend a health~     assessment appointment. They also agree to being followed up over a course of at least 10~     years. The research described here will examine the impact of differing times and formats of~     a self assessment questionnaire on completion rates, specifically:~        -  To assess the effect of being given a questionnaire during a face to face interview with~          a researcher compared to receiving it by post~        -  To explore the potential impact of interview fatigue on completion rates~   "
121396|NCT01978509|"~     The purpose of this study is to compare the efficacy of a low-volume bowel preparation versus~     a high-volume bowel preparation for bowel cleansing on hospitalized patients undergoing~     colonoscopies.~   "
121397|NCT01978496|"~     To confirm the efficacy of three dose levels of oral eletriptan relative to placebo in~     relieving symptoms of acute migraine and to further explore the dose response relationship of~     eletriptan.~   "
121398|NCT01978483|"~     Ultraviolet (UV) light is part of normal sunlight and has many effects on human skin and~     health. One of the harmful effects of long-term UV light exposure is that it can cause skin~     cancer. The mechanism by which UV light causes skin cancer is not entirely understood. One of~     the ways UV light causes cancer is by modifying DNA molecules in the cells of the skin.~     Another mechanism involved in cancer formation by UV light is immunosuppression. By this~     mechanism, UV light inactivates cells of the immune system of the skin. The immune cells are~     responsible for the detection and destruction of foreign substances and organisms such as~     bacterias and viruses but they also recognize and destroy cancer cells. UV light is known to~     prevent cells of the immune system to destroy cancer cells.~      In laboratory experiments, a medication called denosumab has been shown to diminish the~     inhibition of ultraviolet-induced suppression of skin immunity. In other words, this~     medication could block the effect of UV on cells of the immune system and might allow~     patients taking this drug to be better protected from skin cancer.~      The objective of this study is to test whether denosumab blocks the immunosuppressive effect~     of UVB light in healthy subjects. This study is divided into two stages. In the first stage,~     ten subjects (Cohort 1) will be sensitized to diphenylcyclopropenone (DPCP), a topical~     sensitizer commonly used for the treatment of alopecia areata and cutaneous warts. By~     reexposing the subjects to DPCP in incremental doses, dose-response levels of cutaneous~     hypersensitivity reactions in normal skin will be obtained. This will allow comparison of the~     normal levels of DPCP-induced cutaneous hypersensitivity (CHS) reaction in non UV-exposed~     skin (Cohort 1) to the CHS obtained from the two UVB-exposed experimental groups of Cohort 2.~      In the second stage of the study, 20 subjects (Cohort 2) will be exposed to an~     immunosuppressive dose of ultraviolet B (UVB) 24 hours prior to DPCP sensitization. This is~     expected to result in the abolition of CHS upon rechallenge with DPCP. In order to assess~     whether denosumab can reverse UVB-induced immunosuppression, the subjects will have~     previously been randomized to receive a single 1mL injection of either 60 mg denosumab (group~     A; 10 subjects) or 1 mL saline (group B; 10 subjects) two weeks before UVB exposure. CHS~     reactions elicited by DPCP rechallenge will be compared between the denosumab and saline~     groups.~   "
121399|NCT01978470|"~     The purpose of this study is to evaluate the tolerability and safety of the NeuroSigma eTNS~     system.~   "
121400|NCT01978457|"~     We will develop a procedure for conditioning cue-cocaine associations in human drug users.~     Next, we will reactivate that learning and intervene pharmacologically to prevent the~     reconsolidation of cue-drug memories. We hypothesize that a combined behavioral and~     pharmacological approach will have significant potential for persistently inhibiting relapse.~   "
121401|NCT01978444|"~     Radical gastrectomy for gastric cancer with D2 lymph node dissection has been widely applied~     in advanced gastric cancer. However,for most patients,tumor local-regional recurrence has~     been proven unavoidable.~      Recently, many clinical studies have proved that some cancer cells and cancer nodes exist in~     the mesogastrium which can be hardly removed by conventional radical gastrectomy with D2~     lymphadenectomy. It is suggested that Complete mesogastrium excision (CME) is imperative and~     should be added to D2 lymphadenectomy in order to reduce the risk of local recurrence.~      Thus, the comparison of short-term and long-term outcome between laparoscopic D2~     lymphadenectomy plus complete mesogastrium excision and conventional laparoscopic D2~     lymphadenectomy for locally advanced gastric cancer based on a well designed randomized~     controlled trial is needed.~   "
121402|NCT01978431|"~     Examine the interaction between stimulants, such as cocaine and methylphenidate, and~     impulsivity.~   "
121403|NCT01978418|"~     The lungs of the fetus are filled with fluid and it is essential that fetal lung fluid is~     cleared at birth. This process is mediated through the activation of airway epithelial sodium~     channels (ENaC). In animals, ENaC is considered crucial for postnatal pulmonary adaptation.~     In humans, postnatal ENaC expression is dependent on gestational age and its activity,~     measured as nasal potential difference, correlates with lung compliance. Therefore, in the~     human newborn infant ENaC may be important for physiologic postnatal adaptation. The activity~     of ENaC is increased by beta-agonists, such as salbutamol. We hypothesize that low pulmonary~     expression or activity of ENaC in the perinatal period causes delayed clearance of lung fluid~     and thereby contributes to the risk for development of transient tachypnea of the newborn~     (TTN) in term infants born by Caesarean section (CS).~   "
121404|NCT01978405|"~     Contrast-induced acute kidney injury (CIAKI) is a major complication with adverse outcomes~     after contrast media injection. Although the risk of developing CIAKI is low in patients with~     normal renal function, it is dramatically higher in patients with conditions such as diabetes~     mellitus (DM) or chronic kidney disease (CKD). More recently, our data showed that contrast~     agents can induce endothelial dysfunction partially via free radicals in diabetes. Therefore,~     strategies to prevent CIAKI and endothelial dysfunction in DM patients with CKD are urgently~     needed. Alpha-lipoic acid and its reduced form, dihydrolipoate, are potent antioxidants. We~     hypothesized that alpha lipoic acid can prevent the contrast-induced acute kidney injury and~     endothelial dysfunction in type 2 diabetes.~   "
121429|NCT01978067|"~     The aim of this study is to further demonstrate the safety , validity and quality of~     (sexual)life of vaginal operation for previous cesarean scar defect resection.~   "
121406|NCT01978379|"~     We are conducting a study to evaluate two investigational devices that may help us better~     monitor discomfort or pain in anesthetized patients during minimally invasive lung surgery.~     We want to collect information on how people respond to pain related to their surgery.~     Currently, we use blood pressure (BP) and heart rate (HR) to check the response to pain. In~     this study, we will also use two devices called the Medasense PMD-100 and PhysioDoloris~     monitors to look at measurements of pain. We will compare the measurements from the study~     devices to the measurements of heart rate and blood pressure. We hope to enroll about 40~     subjects in this study at the University of Washington Medical Center.~   "
121407|NCT01978366|"~     This study is designed to provide 6-months continuous dosing with the study medication,~     called HT-100, on participants who successfully completed the predecessor study~     (HALO-DMD-01). The main purpose of this study is to assess chronic safety, tolerability,~     pharmacodynamic activity (testing the drug's effect on DMD) and population pharmacokinetics~     (measuring how much drug is in the bloodstream) in participants with a broad spectrum of~     Duchenne muscular dystrophy (DMD).~   "
121408|NCT01978353|"~     Preview research reports evidence of cognitive plasticity among individuals with amnestic~     Mild cognitive Impairment, and small-size studies have suggest that this population can~     benefit from memory training. This project intends to assess the efficacy of cognitive~     training in persons with MCI with a randomized controlled design.~      The hypothesis is that cognitive training can improve memory performance for persons with~     amnestic mild cognitive impairment and this improvement can be maintained over time.~   "
121409|NCT01978340|"~     The study objective is to collect heart rate, respiration rate and motion data of patients~     admitted to sleep lab and to determine the accuracy level of the EarlySense system vs. the~     monitors used in sleep lab (e.g., Polysomnography, respiratory belts, ECG, etc..) . Data~     regarding sleep condition, scoring and quality of sleep and in and out of bed status, patient~     turns will also be collected and compared to data collected by EarlySense contactless~     monitor. Different patient population will be monitored including obese, morbidly obese,~     patients with or without obstructive/central apnea, patients with or without arrhythmia as~     well as healthy population who arrive to sleep lab for general evaluation will be monitored~   "
121410|NCT01978327|"~     GSK2647544 is an orally available, selective inhibitor of Lp PLA2 that is being developed for~     the treatment of Alzheimer's disease. The current study is a single-blind, randomised,~     placebo-controlled, 4-cohort study to assess the safety, tolerability, pharmacokinetics and~     pharmacodynamics of repeat doses of GSK2647544. Cohorts 1, 2 and 3 will evaluate escalating~     doses of GSK2647544 in young healthy volunteers for 7 days, 7 days, and 14 days,~     respectively. Cohort 4 will evaluate repeat doses of GSK2647544 in healthy elderly volunteers~     for 14 days. Additionally, Cohorts 1 and 3 will include an assessment of potential drug-drug~     interaction with simvastatin to examine CYP3A4 inhibition by GSK2647544.~   "
121411|NCT01978314|"~     This is a single site study designed to evaluate the FAST mGFR Test™ in healthy adult~     volunteers, patients with varying degrees of chronic kidney disease (CKD), and patients with~     acute kidney injury (AKI).~   "
121412|NCT01978301|"~     This is a 3-arm randomised clinical enabling study, with no investigational product. Keloid~     patients who are scheduled for surgical excision of one or more keloid scars (up to nine)~     will be recruited to the study. The aim is to investigate how collagen synthesis within~     keloid scars is affected by the current approved steroid treatment for keloids, triamcinolone~     acetonide (TAC). The primary endpoint will be fractional collagen synthesis in keloids which~     have received intra-lesional injections of TAC, placebo or no treatment prior to their~     removal. Fractional collagen synthesis will be determined using an established isotope/mass~     spectrometric technique which measures levels of deuterium incorporation into collagen~     following administration of heavy water to the subject. In addition; keloid tissue samples~     will be evaluated post surgery to identify further biomarkers of extracellular matrix~     synthesis and degradation for application in future clinical studies. Subjects will complete~     a screening visit and will then be randomised to receive three intra-lesional injections of~     TAC or placebo, or no treatment, at an interval of 2-3 weeks. Subjects will be randomised to~     different treatment sequences depending on the number of keloids they have scheduled for~     surgery, in such a way that subjects with multiple keloids will receive different arms of~     study treatment in their different keloids. Planned surgery for removal of their keloid(s)~     will be performed at week 6-8. All subjects will receive daily heavy water (Deuterium oxide)~     administration (twice daily or thrice daily as directed), with the first dose being taken at~     the Week 2 clinic visit and the final dose being taken on the day prior to surgery. A~     follow-up visit will be conducted at 1-4 weeks post-surgery.~   "
121413|NCT01978288|"~     This study tests the hypothesis that an increase in pathogenic bacteria within the infant~     airway leads to increased airway inflammation, decreased airway function and ultimately~     airway obstruction throughout the first one to two years of life.~   "
121414|NCT01978275|"~     Stimulating catheters have been introduced to reduce the incidence of secondary failure after~     continuous peripheral nerve blocks, but they effectiveness over traditional nonstimulating~     catheters is still controversial. Furthermore no volume-response study has compared the~     success rates of the two techniques for continuous lumbar plexus block. The aim of this~     prospective, randomized, blinded study is to detect if stimulating catheters decrease the~     minimal effective volume (MEAV) of 1.5% mepivacaine required for successful lumbar plexus~     block (LPB) in 50% of patients compared with conventional non-stimulating catheters.~   "
121415|NCT01978262|"~     The purpose of this pilot research project is to look at the effect of the inactivated~     influenza vaccine (seasonal flu shot) on early signs of immune or germ-fighting response~     known as cytokines or signal molecules. The investigators also want to see if the timing of~     vaccine administration has any effect on women's reproductive hormones. The investigators~     hypothesis is that influenza vaccine given right before ovulation may change the hormone~     levels usually seen after ovulation. Thi~   "
121416|NCT01978249|"~     Short description for lay public, include brief statement of the study hypothesis~   "
121602|NCT01975818|"~     Evaluate efficacy and safety of 16 weeks of titrated dose treatment with BAY85-3934 versus~     epoetin alfa/beta as measured by hemoglobin (Hb) levels. Fixed starting doses of 25, 50,75~     and 150 mg of BAY85-3934 titrated at the scheduled dose control visits. Titration will be~     based on the subject's Hb response and tolerability of the prior dose. Planned doses include~     15, 25, 50, 75, 100,150 and 200 mg/day~   "
121417|NCT01978236|"~     This is a global, multi-centre, open-label, study of GSK2118436 conducted in up to 30~     evaluable subjects with resectable, BRAF V600E or V600K mutation-positive metastatic melanoma~     to the brain. All subjects in this study are required to have accessible extracranial~     metastases and are agreeable to undergo repetitive biopsies. The first cohort of 15 subjects~     will receive dabrafenib orally 150mg twice daily (BID) for 7 to 14 days prior to surgery~     (Cohort A); the second cohort of 15 subjects will receive the combination of dabrafenib 150~     mg BID and trametinib 2 mg once daily for 7 to 14 days prior to surgery (Cohort B). The~     primary purpose of this study is to determine levels and distribution of dabrafenib, its~     metabolites, and trametinib (Cohort B only) in parenchymal brain metastases, extracranial~     metastases, and peripheral blood (plasma) within two cohorts of subjects with BRAF V600E/K~     mutation-positive melanoma that has metastasized to the brain. All subjects will be followed~     for survival and new anti-cancer therapy for a total of two years or until death or the~     subject wishes to withdraw from further follow-up.~   "
121418|NCT01978223|"~     This study aims to estimate the effectiveness of Rotarix™ vaccine against Rotavirus severe~     gastroenteritis (RV SGE) among hospitalised children aged between 12 weeks and < 5 years, in~     Venezuela and to assess the current disease burden after introduction of the vaccine.~   "
121419|NCT01978210|"~     This pilot study is designed to investigate the feasibility of comparing a standard~     behavioral intervention and an innovative intervention that incorporates the use of a~     wireless moisture alarm in training children with autism how to independently use the toilet~     for urination. We hypothesize that the study protocol will be feasible, as measured through~     review of achieved recruitment targets, successful randomization, and >80% retention of~     subjects with com- plete data collection. Our second hypothesis is that therapists will~     deliver experimental and standard behavioral treatment intervention with ≥80% fidelity and~     parents in both intervention groups will adhere to the intervention with ≥80% fidelity. A~     secondary aim of this study is to examine trends in outcome data by conducting a small RCT (N~     = 30) of wireless moisture alarm and standard behavioral toilet training, with the hypothesis~     that the moisture alarm intervention will result in fewer toileting accidents, a higher rate~     of toileting success and greater parental satisfaction.~   "
121420|NCT01978184|"~     This is a randomized phase II trial that will examine the ability of the hydroxychloroquine~     to improve the clinical activity of a pre-operative regimen of gemcitabine and nab-paclitaxel~     in subjects with potentially resectable adenocarcinoma of the pancreas. Eligible subjects~     will receive 2 cycles of gemcitabine and nab-paclitaxel (day 1, 8, 15) with or without~     hydrocychloroquine followed by surgical resection. Primary endpoint will be histologic~     response as graded by Evans criteria. Secondary endpoints will be CA19-9 response and PET~     response. Pre and post treatment tissue biopsies will be obtained to assess for levels of~     autophagy in tumor, liver and peripheral blood.~   "
121421|NCT01978171|"~     The investigators will determine which factors are predictive for the development and~     severity of everolimus-induced interstitial lung disease and will develop a prediction model~     based on these risk factors.~   "
121422|NCT01978158|"~     Oxygen is a widely available gas that is cheap, easy to get and extensively used in medicine.~     From animal studies it has become apparent that increasing or lowering the degree of oxygen~     in the blood, the inflammatory response can be altered. We will investigate of this is also~     true in humans by increasing, lowering or keeping oxygen levels normal while giving healthy~     subjects a short inflammatory stimulus.~   "
121423|NCT01978145|"~     This is a multi-centre, randomised, double-blind, double-dummy, two way cross-over, 12 weeks~     noninferiority study to evaluate the efficacy, safety, and tolerability of FSC 250/50 mcg~     capsule-based inhaler and a multi-dose inhaler administered BID in adults with COPD. The~     primary objective of this study is to establish the non-inferiority of the efficacy of the~     FSC 250/50 mcg capsule-based inhaler compared to the FSC 250/50 mcg multi-dose inhaler~     administered BID. The study consists of 6 phases: Pre-screening, Screening/Run-in (3 weeks),~     Treatment Period 1 (12 weeks), Washout (minimum 4 weeks), Treatment Period 2 (12 weeks) and~     Follow-up (1 week). The total duration of the study for each subject will be at least 32~     weeks.~   "
121424|NCT01978132|"~     Patients with primary hyperaldosteronism experience more cardiovascular events compared to~     patients with primary hypertension, independent of the blood pressure level.~      In this research we hypothesize that patients with primary hyperaldosteronism are more~     susceptible to ischemia-reperfusion injury.~   "
121425|NCT01978119|"~     This is a multi-centre, randomised, double-blind, double-dummy, two way cross-over, 12 week~     non inferiority study to evaluate the efficacy, safety, and tolerability of FSC 250/50 mcg~     capsule-based inhaler and FSC 250/50 mcg multi-dose inhaler each administered BID in adults~     and adolescents with asthma. The primary objective of this study is to demonstrate that FSC~     250/50 mcg administered BID by capsule-based inhaler is non-inferior compared to FSC 250/50~     mcg administered BID by multi-dose inhaler . The study consists of six phases: Pre-screening,~     Screening/Run-in (3 weeks), Treatment Period 1 (12 weeks), Washout (minimum 3 weeks),~     Treatment Period 2 (12 weeks) and Follow-up (1 week). The total duration of the study for~     each subject will be at least 31 weeks.~   "
121426|NCT01978106|"~     Purpose of this study is to compare the astigmatic power of the toric IOL obtained from the~     AcrySof toric calculator, TECNIS toric calculator, and iTrace toric calculator in a group of~     patients with preoperative with-the-rule (WTR) and against-the-rule (ATR) corneal~     astigmatism. The study included 100 eyes with cataract and greater than 0.75 diopter of~     corneal astigmatism, and the subjects were divided into WTR and ATR group. Keratometric value~     was measured using autokeratometry, IOLMaster partial coherence interferometry (PCI), iTrace~     incorporating corneal topography and ray-tracing aberrometry. Based on measured values, toric~     IOL power calculations were performed using AcrySof, TECNIS and iTrace toric calculators.~   "
121427|NCT01978093|"~     The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of GSK~     Biologicals' Hib-MenCY-TT (MenHibrix®) vaccine co-administered with Rotarix, Prevnar 13 and~     Havrix as compared to PedvaxHIB co-administered with Rotarix, Prevnar 13 and Havrix in~     infants and toddlers.~   "
121428|NCT01978080|"~     The specific aim of this study is to evaluate if tremor severity and quality of life can be~     improved more using continuous home monitoring along with traditional assessments versus~     traditional assessments alone.~   "
121431|NCT01978041|"~     The importance of fluoridated water to control caries is well recognized. Although the mode~     of action of fluoridated water is known (related to a slight increase in fluoride~     concentration in saliva/dental biofilm in individuals living in fluoridated areas), the~     kinetics of fluoride concentration in saliva after ingestion of food prepared with~     fluoridated water, either from fluoride remaining in the oral cavity after mastication, or~     from fluoride returning from salivary secretion is not known in details. Therefore, the aim~     of this study is to assess fluoride bioavailability after ingestion of food prepared with~     fluoridated water. The study will be in vivo, crossover and double blind, in which 12 adult~     volunteers will participate. In 4 experimental phases, volunteers will ingest: a. a typical~     Brazilian meal cooked with non-fluoridated water (<0.1 ppm F); b. a typical Brazilian meal~     cooked with fluoridated water (1 ppm F); c. non fluoridated water (<0.1 ppm F) and d.~     fluoridated water (1 ppm F). Immediately before and 5, 10, 15, 30, 45, 60, 120, 180 minutes~     after the ingestion, a blood sample will be collected by digital puncture, and a sample of~     unstimulated saliva will be collected. Fluoride concentration in the samples will be~     determined by an ion specific electrode adapted for microanalysis. Results will be analyzed~     by ANOVA, with significance limit of 5%.~   "
121432|NCT01978028|"~     The primary efficacy objective of this study is to evaluate the effect of ferric~     carboxymaltose on mitochondrial gene activation pattern after 12 weeks of treatment.~   "
121433|NCT01978015|"~     Glaucoma, a progressive optic disc neuropathy causing visual field reduction, is the second~     leading cause of world blindness. The treatment of glaucoma is mainly based in reducing~     intraocular pressure (IOP) with topical medications. Many patients required two or more~     medications to achieve a target IOP. Combinations of B-blockers and prostaglandin analogs~     (PGA) are frequently used in clinical practice because their additive effect in lowering IOP~     levels. The aim of this study was to investigate the effects of fixed combinations of timolol~     maleate and PGA on the blood-aqueous barrier and evaluate the measurement of foveal thickness~     in pseudophakic patients with primary open-angle glaucoma (POAG).~   "
121434|NCT01978002|"~     Bladder pain and discomfort, as well as urinary urgency and frequency, are bothersome~     symptoms seen frequently in the general population. Clinical diagnostic terms used to~     describe these symptoms include interstitial cystitis (IC), bladder pain syndrome (BPS),~     chronic prostatitis, and overactive bladder (OAB), but there is tremendous overlap between~     these entities, and the distinction between them is based more on eminence than evidence.~      Pain and/or sensory sensitivity has been suspected to play a role in the pathogenesis of both~     bladder pain and urinary urgency/frequency. However, no previous studies have investigated~     whether entities such as IC/BPS and OAB might merely represent different points in a~     continuum of bladder sensory sensitivity. Moreover, we know of no studies that have directly~     compared sensory sensitivity in the bladder to global (i.e. CNS-mediated) sensory~     sensitivity.~      In the study, a team of investigators with complementary expertise will perform a~     population-based study assessing bladder and overall sensory sensitivity, in a cohort of~     women representative of the population with respect to the entire continuum of bladder pain~     (from none to severe), and symptoms of urgency/frequency. These individuals will undergo~     urodynamics to measure sensory sensitivity in the bladder, as well as pressure pain and~     auditory loudness thresholds. The Specific Aims are to demonstrate: 1) sensory sensitivity in~     the bladder is related to sensory sensitivity elsewhere in the body, suggesting a CNS-driven~     mechanism, and 2) individuals in the population with greater global sensory sensitivity will~     display: a) more bladder pain, b) more urgency/frequency, and c) other symptoms of~     centrally-mediated pain states, such as pain in regions other than the bladder, fatigue, and~     insomnia.~   "
121435|NCT01977989|"~     The purpose of this study is to study how well using a powdered form of the antibiotic,~     vancomycin, inside the surgery wound prevents infection in patients undergoing instrumented~     spinal surgery for traumatic injury to the back.~      Vancomycin is approved by the United States Food and Drug Administration (FDA) for treating~     certain kinds of bacteria. It is also used to prevent infections of the surgery site.~      This will be a study in which the experimental treatment is compared to a standard (control)~     treatment. It will be prospective in nature, meaning that it will follow patients forward in~     time, and it will consist of a randomization process to determine who will receive the~     experimental treatment versus the standard (control) treatment.~      The study will take place at Regional Medical Center (The MED). 140 subjects will be~     participating in this study.~      The investigators hypothesize that the topical use of powder vancomycin will decrease the~     rate of surgical site infection.~   "
121436|NCT01977976|"~     Implantation failure remains one of the major factors limiting success in IVF treatment. It~     was postulated that the local injury to endometrium induces secretions of cytokines and~     growth factors such as leukemia inhibitory factor, interleukin-11, and heparin-binding~     EGF-like growth factor which enhance decidualisation and facilitate implantation. It may also~     up-regulate the gene expressions related to endometrial receptivity and optimize the~     endometrial development. In stimulated cycles, local injury to the proliferative endometrium~     has been postulated to delay endometrial development thereby inducing synchronicity between~     endometrium and embryo stage and facilitate implantation (Zhou et al, 2008; Almog et al,~     2010; Gnainsky et al, 2010) The aim of the study is to determine whether endometrial injury~     by endometrial biopsy in mid-secretory phase of the preceding cycle would improve the~     on-going pregnancy rate in subfertile women undergoing IVF treatment.~   "
121444|NCT01977872|"~     JointADventure: A worksite activity-diet intervention for chronic knee pain is a randomized~     controlled trial evaluation of a physical activity and nutritional worksite intervention to~     decrease symptoms and disability associated with knee osteoarthritis (OA), a major public~     health problem and a leading cause of work disability and work absenteeism/presenteeism in~     the US workforce.~      The overarching goal of this project is to find an effective and sustainable intervention~     strategy that can assist large populations of persons with or at risk for knee OA to attain~     and maintain healthy dietary and physical activity behaviors. This project has to potential~     to have a tremendous impact on improving symptoms and quality of life of persons with chronic~     knee pain and decreasing the functional limitation, work absenteeism/presenteeism, and~     soaring healthcare utilization associated with knee OA.~   "
121445|NCT01977859|"~     The purpose of this study is to collect data to help researchers better understand the~     various causes of obesity, which may lead to the development of new obesity treatment~     options.~   "
121437|NCT01977963|"~     Thionamides, the antithyroid drugs, have been widely used to treat hyperthyroidism1. Side~     effects are found in 1% - 5% of the patients1. One of the most serious side effect is~     agranulocytosis, which occurs in 0.1% - 0.3 % of the patients1. This might lead to severe~     infection and sometimes mortality. The underlying mechanism is unclear. An immune phenomenon~     may be involved because the antigranulocyte antibodies or lymphocyte sensitized to~     antithyroid drugs are found in these patients6,7. The recognition of major histocompatibility~     complex class II peptide complexes by T lymphocytes is central to the development of immune~     response. According to a report in 1996, the HLA DRB1*08032 allele is strongly associated~     with susceptibility to methimazole-induced agranulocytosis20.~      Recently, there are new techniques for genetics study. We aimed to identify the associated~     genetic change of the agranulocytosis side effect of antithyroid drugs. First, we will look~     at the classical human Leukocyte Antigen (HLA) loci, such as HLA-A, -B, -C, -DR, -DQ and -DP.~     If no significant change is found in the above genes, we will consider whole exon sequencing~     with next-generation sequencing, Statistic analysis will include appropriate linkage~     analysis, association study, variation data analysis, pathway analysis. If we can identify~     the genetic change and perform genetic examinations before prescription, we can avoid the~     happening of severe side effects.~   "
121438|NCT01977950|"~     The purpose of this study is to estimate the prevalence of nutritional risk and examine~     nutritional care practices in the hospitalized elderly at one large university hospital in~     Norway.~   "
121439|NCT01977937|"~     The purpose of this study is to evaluate the patient experience when using gabapentin with~     other pain control medications after posterior spinal fusion surgery for scoliosis in~     adolescents. These results will be compared to patients who underwent the same procedure~     during the study period and received the same standardized pain control regimen excluding~     gabapentin. Effects on pain level, opioid use, and satisfaction will be measured. Opioid side~     effects including nausea, sedation and urinary retention (inability to empty one's bladder)~     will also be recorded.The null hypotheses are as follows:~        1. There is no significant difference in pain control when adding gabapentin to a~          multimodal pain management protocol in pediatric post-operative posterior spinal fusion~          patients.~        2. There is no significant difference in the amount of opioid medication required for pain~          control in pediatric post-operative posterior spinal fusion patients.~   "
121440|NCT01977924|"~     Severe obstructive sleep apnea (OSA) is associated with increased cardiovascular morbidity~     and mortality. Endothelial dysfunction, an early marker of vascular disease has been~     demonstrated in OSA. Regular treatment of OSA by continuous positive airway pressure (CPAP)~     improves endothelial function and is associated with a reduction in cardiovascular risk.~     Approximately 40% of patients with OSA are intolerant or insufficiently adherent to CPAP.~     Alternative treatments or adjuvants to the CPAP are needed.~      The polyphenols have demonstrated their effectiveness in improving endothelial function in~     patients with CV disease. No randomized controlled studies have evaluated the impact of PPR~     on the endothelial dysfunction associated with OSAHS.~   "
121441|NCT01977911|"~     This study aims to test a new groundbreaking treatment for narrowing of the voicebox and~     upper windpipe, which can be due to injury, inflammatory disease or cancer treatment.~     Narrowing of the voicebox or upper windpipe can leave patients dependant on a tracheostomy~     tube to breath through (a tube or hole in the neck), which can require a high level of care~     with regular hospital visits and can lead to recurrent chest infections. Regular surgical~     procedures may be necessary to widen the airway. Speaking may be very difficult or not even~     possible, breathing is usually a struggle and swallowing can also be affected. Patients feel~     very tired all the time.~      The new treatment tested by this study is an implant that will partially replace the voicebox~     or upper windpipe in order to cure the narrowing. The implant is based on a human donor~     voicebox or windpipe that has been processed with detergents and enzymes in order to remove~     all the cells from the donor, leaving a 'scaffold' of connective tissue. The patient's own~     stem cells are removed from the bone marrow, then are grown on the scaffold in the~     laboratory. These cells will form the cartilage in the wall of the scaffold. A split skin~     graft from the patient may be needed to line the inside of the implant. The implant can be~     considered 'living' due to the cells grown on it, and this type of treatment is referred to~     as 'tissue engineering' or 'regenerative medicine'.~      Once these cells have attached and started to grow on the scaffold, it is ready to be~     implanted into the patient, and an operation is performed which occurs in two separate~     stages. The final stage of the operation involves removing the narrow section of voicebox or~     upper windpipe and implanting the scaffold to reconstruct it. Patients will be followed up~     for two years after this operation, with investigations such as CT scans, examination of the~     voicebox and windpipe with a flexible camera (bronchoscopy) and blood tests performed at~     specific times.~      It is intended that this treatment will significantly improve patients' symptoms resulting in~     better breathing, swallowing and voice function, reducing the need for repeated hospital~     visits and procedures and enhancing patients' quality of life.~   "
121442|NCT01977898|"~     The purpose of this study is to evaluate the use of intrathecal morphine administration~     following an unintentional dural puncture, to decrease the incidence of post dural puncture~     headaches (PDPH) in obstetric patients.~   "
121443|NCT01977885|"~     Our greatest public health challenge is obesity and the co-morbidities of metabolic syndrome~     (MetS). Age is an established risk factor for MetS and specific to women, data indicates that~     the prevalence of MetS increases substantially with the menopausal transition with~     postmenopausal women having a 60% increased risk of MetS. Menopause also contributes to~     reductions in strength, physical function and often psychological well-being (e.g. fatigue).~     Obese individuals also have: a) impaired immune function and chronic inflammatory responses~     associated with changes in the white blood cell population in blood and fat tissues; and, b)~     increased secretion of and signaling by proteins in their fat cells. Weight loss, which~     requires an energy deficit through increased physical activity and/or caloric restriction~     (EX+CR), reduces risk for MetS in older sedentary obese women by reducing insulin resistance~     and chronic systemic inflammation. Science and clinical practice will be advanced by~     examining the molecular mechanisms by which EX+CR affects risk for MetS in older women. The~     primary aim is to determine if CD4+ T cells will report the differential epigenetic~     reprogramming of relevant gene expression associated with metabolic indices resulting from~     EX+CR induced weight loss in older women known to be at risk for MetS. This pilot data will~     be used to generate an NIH proposal of the same topic. A secondary aim is to assess the~     impact of weight loss on physical function and psychological well-being which will provide~     pilot data for an additional grant proposal regarding weight management in postmenopausal~     women.~   "
121463|NCT01977625|"~     This study seeks to assess the effects of lisdexamfetamine (trademark name: Vyvanse; LDX) on~     executive function and prefrontal cortex activation in menopausal women ages 45-57, who~     report subjective cognitive difficulties. This protocol will recruit women from Dr.~     Epperson's ongoing study, Protocol #812470, to examine the impact of LDX on brain activation~     during performance of cognitive tasks specifically probing prefrontal cortex function.~   "
121446|NCT01977846|"~     Stargardt disease is currently an incurable and untreatable macular dystrophy that causes~     severe visual loss in children and young adults, thereby causing enormous morbidity with~     economic, psychological, emotional, and social implications. There are no FDA approved~     therapeutic treatments for this disease. Therefore, the objective of this study is to collect~     natural history data from a large population of children and adults in order to evaluate~     possible efficacy measures for planned clinical trials.~      Participants will be recruited from each Investigator's own patient population as the study~     requires the availability of both multiyear retrospective data, as well as ongoing~     prospectively collected data. A concurrent ancillary study (SMART study) is also being~     conducted with a subset of the prospective study patients during their regular ProgSTAR study~     visits to expand the collection of retinal images to include microperimetry measurements~     gathered under scotopic (low light) conditions.~   "
121447|NCT01977833|"~     Enhanced insulin and GLP-1 postprandial response after morning meal versus evening meal,~     might be underlying explanation of the beneficial effect of eating breakfast with reduced~     dinner vs skipping breakfast on glycemic control and HbA1c in T2D patients.~      To test this hypothesis and clarify whether glucose, insulin and GLP-1 postprandial responses~     are different in the morning vs. in the afternoon, the investigators will compare in T2D~     subjects in random order and in two separate days: the glucose, insulin and GLP-1~     postprandial responses after breakfast, lunch and dinner with 2 isocaloric meal plans or test~     diets, that differ in meal timing distribution The investigators hypothesize that GLP-1 and~     insulin response after high calorie breakfast will be higher in comparison to GLP-1 and~     insulin response after identical meal at evening~   "
121448|NCT01977820|"~     This is a Phase 2a multicenter, double-blind, placebo-controlled, randomized, 2-arm pilot~     trial designed to assess the effect of sapropterin on cognitive abilities in young adults~     with Phenylketonuria (PKU) over a 26-week treatment period.~   "
121449|NCT01977807|"~     This clinical study has been planned to evaluate the safety and effectiveness of common~     treatment algorithms using 500 Hz laser repetition rate.~   "
121450|NCT01977794|"~     This is a randomized, comparative Phase 3 trial to investigate the efficacy of fixed dose~     combination (FDC) of bisoprolol and amlodipine in hypertensive subjects (superiority of FDC~     over monotherapies).~   "
121451|NCT01977781|"~     The purpose of this study is to evaluate the safety and tolerability of topical tacrolimus~     0.05% twice a day in the treatment of ocular graft versus host disease (GVHD).~   "
121452|NCT01977768|"~     The purpose of the study is to identify optimally effective dose of whole-cell, heat-killed~     Mycobacterium vaccae formulated as a pill and consequently carry out multi-country,~     placebo-controlled, randomized Phase III trial in patients with drug-sensitive, multi-drug~     resistant (MDR-TB) and TB-HIV.~   "
121453|NCT01977755|"~     This study explores the potential cardioprotective properties of danegaptide when~     administered to patients with ST-Segment elevation myocardial infarction.~   "
121454|NCT01977742|"~     Purpose: to investigate the hypothetical additive value of a sudden rest-exercise training~     over the cardiac vagal of cardiac patients in a supervised exercise program.~   "
121455|NCT01977729|"~     The purpose of this study is to determine whether cognitive behavioral therapy (CBT) in~     combination with sertraline (SRT) is more effective than SRT alone in treating children and~     adolescents with anxiety disorders (after an initial 8 weeks of CBT).~   "
121456|NCT01977716|"~     The primary objective is to analyze peritonitis rate and peritonitis bacteriology as risk~     factors for loss of residual renal function, technique failure and mortality in chronic~     kidney disease patients.~      Secondary objectives are: To know the current rate of peritonitis in peritoneal dialysis~     population and to understand the bacteriological profile of peritonitis.~      To know the rate and risk factors other than peritonitis involved in the loss of residual~     renal function.~      To analyze the utility of alternative diagnostic tests, such as reagent strips, for early~     detection of peritonitis when traditional tests are not available.~      To analyze the simultaneous measurement of serum creatinine and cystatin-C as alternative~     measurements of peritoneal clearance and residual renal function.~   "
121457|NCT01977703|"~     We propose to study a strategy empirically applied for the past 6 months at a high volume~     LVAD center (Vanderbilt Heart and Vascular Institute). This utilizes an ultra conservative~     device programming strategy to maximize battery longevity, avoid inappropriate implantable~     cardioverter defibrillator (ICD) therapy, improve quality of life through reduction in~     overall shock burden, and potentially avoid unnecessary device generator changes prior to~     transplant. Avoiding CIED (cardiac implantable electronic device) change out device~     procedures prior to transplant is desirable.~   "
121458|NCT01977690|"~     The purpose of the study is to see whether a clavicle splint can decrease the pain after~     posterior cervicothoracic surgery. The term cervicle splint conveys that the investigators~     do not deal with clavicle fractures here but use the splint he stabilize the posterior~     cervical area. The investigators want to demonstrate this in a prospective randomized manner.~   "
121459|NCT01977677|"~     This pilot phase I/II trial studies the side effects and best dose of plerixafor after~     radiation therapy and temozolomide and to see how well it works in treating patients with~     newly diagnosed high grade glioma. Plerixafor may stop the growth of tumor cells by blocking~     blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Radiation therapy uses high energy x rays to kill tumor cells. Giving plerixafor~     after radiation therapy and temozolomide may be an effective treatment for high grade glioma.~   "
121460|NCT01977664|"~     Donated oocytes is from a patient with repeated oocyte maturation failure in IVF cycles.~     Cytoplasm of matured metaphase II oocyte and active MPF were injected into the donated~     oocytes.~   "
121461|NCT01977651|"~     The objective of this study is to evaluate the incidence of seizures and monitor the safety~     of enzalutamide treatment in subjects with metastatic castration-resistant prostate cancer~     known to have risk factor(s) for seizure.~   "
121462|NCT01977638|"~     The purpose of this study is to determine the highest dose of CXD101 (a novel histone~     deacetylase inhibitor) that can be safely administered to patients with advanced tumours. The~     study will also investigate the use of HR23B expression in tumour as a biomarker of response~     to treatment with CXD101. Patients with solid tumours, lymphoma and myeloma can be considered~     for this study.~   "
121464|NCT01977612|"~     Women with gynecologic cancers are often obese and have other risk factors for post-operative~     wound separation. Data from obstetrics and orthopedic surgery literature have shown a~     decreased risk of wound separation and complications when the skin is closed with suture as~     compared to staples. Skin closure with either staples or suture is considered standard of~     care. Traditionally, most wounds have been closed with staples given their ease of use and~     quick application. In this randomized study the investigators plan to evaluate and compare~     the complication rate associated with both standard closures.~   "
121465|NCT01977599|"~     Breast Cancer is the single most common cancer, and the third leading cause of cancer cancer~     deaths, in the United Kingdom. Breast screening is able to detect breast cancer in the early~     stages of development, during which time it is more easily treatable. Unfortunately, many~     patients do not attend screening, and surveys issued to these women consistently report~     forgetfulness as the primary reason for missing the appointment. Both telephone reminders~     and postal reminders have been shown to reduce non-attendance, however, these are time~     consuming and expensive.~      Mobile telephones are becoming an increasingly popular tool for communication between~     healthcare professionals and patients, one which might offer an inexpensive solution for~     delivering reminders. Text message reminders have been able to prevent missed appointments in~     other areas of healthcare, and the same might be true for breast screening.~      The investigators are conducting a trial to confirm whether this is the case or not.~      In this trial, the investigators will send some women a text message to reminder them of~     their appointment, and other women no reminder for their appointment. The investigators will~     then compare the number of women in each group that went to their breast screening~     appointment.~   "
121466|NCT01977586|"~     The aim of this study is to assess whether functional magnetic resonance imaging (MRI)~     techniques are able to detect which patients with metastatic renal cell carcinoma will derive~     benefit from treatment with anti-angiogenic drugs early in their treatment. Early response~     assessment would allow selection of the most appropriate treatment option for each individual~     patient.~   "
121467|NCT01977573|"~     This study will be conducted in approximately 228 subjects with anemia associated with CKD~     who are not on dialysis. Two groups of subjects will be enrolled into the study: Group 1:~     recombinant human erythropoietin (rhEPO) naive subjects; Group 2: rhEPO users, who are~     currently receiving rhEPO. Subjects who are rhEPO naive will be randomized to receive either~     GSK1278863 once daily (QD) or rhEPO in a 3:1 fashion; subjects who are receiving an rhEPO~     before enrolling (rhEPO users) will be randomized in a 1:1 fashion to GSK1278863 QD or to the~     control arm. For those randomized to the control arm, the decision around whether the subject~     requires rhEPO, the selection of the type of rhEPO (if needed) and the choice of rhEPO dose~     to achieve and maintain Hgb concentrations within the target range should be based on~     Investigator clinical judgment, with the historical rhEPO dose and the current Hgb value~     being considered. The study consists of a screening phase of at least 4 weeks, a 24-week~     treatment phase and a follow-up visit that will occur approximately 4 weeks after completing~     treatment. It is anticipated that the data generated will enable selection of the starting~     dose(s) and optimize dose adjustment regimen(s) for Phase 3 clinical trials.~   "
121468|NCT01977560|"~     The purpose of this study is to determine the effect of lifestyle intervention on metabolism~     and blood sugar control in Type 2 Diabetics.~   "
121469|NCT01977547|"~     ABC PICU is a randomized clinical trial that will compare the clinical consequences of RBC~     storage duration in 1538 critically ill children. Laboratory and observational evidence~     points to serious concerns about the lack of safety and effectiveness of older RBCs,~     especially in more vulnerable populations. Physicians and institutions have been~     systematically transfusing fresh RBCs to some pediatric patients primarily because of beliefs~     that the use of fresh RBCs improve outcomes. Conversely, the standard practice of blood banks~     is to deliver the oldest RBC unit in order to decrease blood wastage. To provide much needed~     high quality evidence to answer the question do RBCs of reduced storage duration improve~     outcomes? The ABC PICU Trial will conduct a RCT comparing development of New or Progressive~     Multiple Organ Dysfunction Syndrome (NPMODS) in critically ill children transfused with~     either RBCs stored ≤ 7 days or standard issue RBCs (expected mean RBC storage duration of~     17-21 days).~   "
121470|NCT01977534|"~     The purpose of this study is to determine the safety and clinical outcomes of the Absorb BVS~     for daily use in patients with de novo lesions in previously untreated vessels.~   "
121471|NCT01977521|"~     The present study aims to examine the efficacy of transcranial direct current stimulation on~     the severity of auditory hallucinations.~   "
121472|NCT01977508|"~     Multicentre, prospective, observational post-market registry. To monitor and collect data on~     the post-market clinical safety and performance of the Vascutek Rapidax II Vascular Access~     Graft.~   "
121473|NCT01977495|"~     The investigator plans to assess enrollment rates among two different enrollment methods,~     while providing a behavioral economic intervention to enhance the uptake of home-health~     monitoring devices to lower hemoglobin A1C among patients with uncontrolled diabetes. The~     study is focusing on enrollment methods since the standard randomized control trial only~     reaches 15% of the population. The study is seeking to understand the effectiveness of a~     behavioral intervention, when rolled out in a larger population.~   "
121474|NCT01977482|"~     This study is intended to evaluate the dose-response relationship of GSK1278863 over the~     first 4 weeks of treatment and evaluate the safety and efficacy of GSK1278863 over 24 weeks~     to maintain hemoglobin (Hgb) level in hemodialysis-dependent (HDD) subjects with anemia~     associated with chronic kidney disease (CKD) who are switched from a stable dose of~     recombinant human erythropoietin (rhEPO). The data generated will enable selection of the~     starting dose(s) and optimize dose adjustment regimen(s) for Phase 3 clinical trials.~   "
121510|NCT01977014|"~     This observational study aims to chart patients which get their prostacyclin treatment via~     the subcutaneous LenusPro pump. How the surgical procedure is performed and the clinical~     follow-up of these patients. And by this also charting complications that might occur in~     relation to treatment.~      Participating centres are located in Denmark, Norway and Sweden.~   "
122063|NCT01969773|"~     This study was designed in a multicenter, randomized, double-blind, placebo controlled trial~     to test the actual therapeutic effects of intravesical BoNTA injection. The results of this~     study might provide clinical evidence for a better therapeutic regimen in the treatment of~     IC/PBS.~   "
121475|NCT01977469|"~     The local and systemic manifestations that affect patients with Chronic Obstructive Pulmonary~     Disease (COPD) cause severe dyspnoea and limitation of functional capacity, leading to~     impairment in the performance of activities of daily living (ADL). The combination of aerobic~     and resistance training, for both upper limbs (UL) and lower limbs (LL), appears to be the~     physiologically most complete resource for improving quality of life and increased survival~     of these patients. Therefore, the aim of the study is to assess the impact of aerobic and~     resistance training of different intensities on the performance and dyspnoea during~     activities of daily living and prediction of mortality in patients with COPD. There will be~     include 30 COPD patients with moderate to severe obstruction, aged between 50-80 years of~     both gender. All patients will undergo to the following assessments and reassessments:~     history and anthropometric data, Scale London Chest Activity of Daily Living Scale (LCADL),~     modified Medical Research Council (mMRC), BODE index, test peripheral muscle strength,~     mobility and balance tests, 6-minute walk test (6MWT), Circuit ADL Test, 1 repetition maximum~     (1RM) and Incremental Cardiopulmonary Testing (ICPT). Patients will be randomly divided into~     two groups and undergo to the treatment program will consist of sessions lasting~     approximately 1 hour, three times a week for 12 consecutive weeks, totaling 36 sessions. All~     patients will undergo general stretching and aerobic training on a cycle ergometer with the~     intensity between 70-80 % of the maximum load achieved in ICPT. After aerobic training, a~     group of patients will achieve a protocol of low-intensity resistance training (LI-RT), with~     emphasis on gaining muscle strength, and the other group will be submitted to a protocol of~     high intensity (HI-RT), aiming greater gain in muscle strength. The calculation of the~     intensity of training will be conducted by the 1RM test. After the training protocol, it is~     expected to find improved performance and dyspnoea during activities of daily living and~     reduction of BODE index for both groups, however, it is expected that the group of~     low-intensity resistance training presents greater benefits in ADL.~   "
121476|NCT01977456|"~     The primary goal of this trial is to determine if individuals with acute ischemic stroke~     treated with a full dose of IV recombinant tissue plasminogen activator (rt-PA) plus IV~     eptifibatide started within 3 hours of symptom onset are more likely to have a better outcome~     than individuals treated with standard IV rt-PA alone.~   "
121477|NCT01977443|"~     A randomized, double-masked, placebo-controlled, multi-centre phase IIa proof-of-concept~     study to evaluate efficacy and safety of APD-209 Eye drops for treatment of acute phase~     adenovirus-induced EKC. The aims of the study are to investigate the therapeutic efficacy of~     APD-209 Eye drops as measured by adenoviral load, time to viral eradication, clinical~     resolution of EKC (objective and subjective assessments), presence of opacities, visual~     acuity and frequency of second eye infections, and to assess the safety and tolerability of~     APD-209 Eye drops in EKC infected eyes.~   "
121478|NCT01977430|"~     Introduction: Chronic kidney disease is characterized by a progressive deterioration of renal~     function. At the end of the progression, when complications occur (overhydration, electrolyte~     imbalances or retention of uremic toxins), a percentage of patients requiring renal~     replacement therapy (haemodialysis). When starting the haemodialysis, the patient holds the~     residual renal function (RRF) which is lost over time. To preserve the RRF, the patient is~     treated with diuretics loops and / or thiazide diuretics. The effect of this treatment is~     lost when renal function worsens. In this context, there are few studies that explore the use~     and effectiveness of diuretics in patients on haemodialysis 2. Objectives and Hypothesis:~      Hypothesis: The treatment with furosemide and hydrochlorothiazide in haemodialysis patients~     with RRF could:~        -  To decrease in weight gain between haemodialysis sessions.~        -  To increase urine volume.~        -  To decrease the ultrafiltration in haemodialysis sessions ( the long interdialytic~          interval)~      Main Objective:To asses the effect of combined hydrochlorothiazide-furosemide therapy on gain~     weight between haemodialysis sessions in patients with RRF~      Secondary Objective: To asses the effect of combined hydrochlorothiazide-furosemide therapy~     on dialytic, clinical and analytical variables and use of the antihypertensive treatment~      3. Methodology: Randomized open clinical trial to compare the effectiveness of the~     administration of diuretics in haemodialysis patients with residual renal function in single~     centre.~      The population of study are patients with chronic renal disease in haemodialysis therapy that~     they preserve residual renal function ( more 200ml daily of urine). It will be a simple~     randomization, to asses the effect of combined hydrochlorothiazide-furosemide therapy~      After a of 15 days washout without diuretic treatment, patients will be randomized to receive~     or not receive combined diuretic treatment for 1 month. After a 1 month washout , the~     patients will be receive or not the treatment according to cross over trial.~   "
121479|NCT01977417|"~     Prediabetes, characterized by elevated fasting blood sugar or exaggerated blood sugar~     response to sugar ingestion, effects over 79 million adult Americans and is a precursor to~     the development of Type 2 diabetes. Importantly, approximately 42% of Iowans (950,000) have~     diabetes and 32% (670,000) have prediabetes with the majority of those with prediabetes going~     undiagnosed. Adults with prediabetes demonstrate early signs of cardiovascular and nervous~     system abnormalities and are at high risk for developing overt diabetes unless aggressive~     lifestyle (weight loss, exercise) or pharmacological interventions are employed.~     Interestingly, data in recent years has linked obesity and diabetes to chronic inflammation~     of the blood vessels and brain areas that regulate blood pressure. Therefore, the current~     study will test whether a commonly used aspirin-like anti-inflammatory drug called salsalate,~     will improve blood vessel health and nervous system dysfunction in adults with prediabetes.~     Eligible subjects will have measurements of blood pressure, blood vessel function in the arms~     and eyes, assessments of nerve activity, and blood samples taken before and after 4 weeks of~     ingesting an FDA approved aspirin-like drug called salsalate. The study is important because~     it will identify a potentially new pharmacological strategy to treat vascular and nervous~     system abnormalities in overweight and obese adults with early stage type 2 diabetes using an~     inexpensive, generically available drug with an excellent safety record that has been used~     for decades to treat chronic inflammatory conditions such as rheumatoid arthritis. If proven~     effective, this will provide preliminary support for the concept of targeting inflammation as~     a new clinical approach to treating early diabetes related complications. Furthermore, the~     current pilot study will provide support for developing a larger clinical trial using~     salsalate that could potentially then be extended to patients with type 2 diabetes and~     cardiovascular disease, as well as lead to the development of new anti-inflammatory agents~     with greater specificity for selective inflammatory pathways.~   "
121480|NCT01977404|"~     This study objective is to assess the nutritional status of Patients With Congestive Heart~     Failure.~   "
121481|NCT01977391|"~     Diabetes mellitus is known to increase the risk of premature death in the general population.~     In this study, the investigators examine the impact of body mass index (BMI) levels, waist~     circumference, and presence/absence of diabetes on all-cause and cardiovascular mortality in~     elderly Koreans.~   "
121482|NCT01977378|"~     A multicenter, 10-week study to evaluate the efficacy and safety of Sustained-Release~     Desvenlafaxine Hydrochloride versus Sustained-Release venlafaxine Hydrochloride in adult with~     major depressive disorder.~   "
121483|NCT01977365|"~     Hypothesis N°1: The children growth promotion based on approach centered on their specific~     needs enhances caretakers and health workers skills, knowledge and practices on~     breastfeeding, complementary feeding and child care.~      Hypothesis N°1: children growth promotion based on approach centered on their specific needs~     approach improves children growth and health.~   "
121484|NCT01977352|"~     The purpose of this study is to compare the quality and duration of pain relief after~     shoulder surgery provided by a single injection of liposomal bupivacaine versus standard~     bupivacaine when administered as an interscalene brachial plexus block. It is hypothesized~     that the liposomal bupivacaine formulation will provide more effective pain relief than~     standard bupivacaine.~   "
121485|NCT01977339|"~     The purpose of this study is to compare the quality and duration of pain relief after a total~     knee replacement provided by a single shot of standard bupivacaine versus a single shot of~     liposomal bupivacaine, at the site of the femoral nerve. It is hypothesized that the~     liposomal bupivacaine formulation will provide more effective pain relief than standard~     bupivacaine.~   "
121486|NCT01977326|"~     The objective of this randomised controlled trial (RCT) is to determine the effectiveness and~     cost-effectiveness of a task sharing counseling intervention for maternal depression in South~     Africa(i.e. provided by non-specialist health workers)~   "
121487|NCT01977313|"~     It is known that with increasing age sexual desire is declining in women. Decreasing levels~     of androgens are believed to have an influence, but cannot explain the loss of libido~     completely. A possible explanation might be that the effect of the androgen is depending on~     the functionality of the androgen receptor. It is known that this functionality is~     genetically determined by the polymorphism of the androgen receptor gene. In the gene there~     is a varying number of CAG-repeats: the longer the CAG-Repeat, the lower the functionality of~     the androgen receptor, the lower the effect of the androgens. In this pilot study, the~     investigators would like to invite 45 healthy heterosexual middle-aged women to the~     University Hospital of Bern, where they answer questionnaires about their sexual function and~     where they give a blood sample to assess the testosterone serum levels and the genetically~     determined androgen receptor subtype.~      The investigators believe that lower androgen levels and/or longer CAG-repeats in the~     androgen receptor gene are related to lower libido scores in healthy middle-aged women.~   "
121488|NCT01977300|"~     Hypothesis: Continuation of an atypical antipsychotic medication in combination with a Mood~     Stabilizer, following remission from an acute manic episode, lowers the rates of relapse and~     recurrence of mood episodes compared to discontinuing the antipsychotics within days of~     resolution of manic symptoms.~   "
121489|NCT01977287|"~     This investigation consists of two parallel groups of participants who will follow the same~     protocol. The aim of the study is to investigate the effects of using Functional Electrical~     Stimulation/Ankle Foot Orthosis (AFO) or splint as an assistive mobility device over a 12~     week period in people with MS who experience foot drop. Patients who are clinically~     prescribed FES will be invited to participate in the FES arm of the study. Patients who are~     clinically prescribed an AFO will be invited to participate in the AFO arm. Participants will~     be asked to make four visits to the gait laboratory at Queen Margaret University. Four weeks~     before the start of device use (Baseline - 4 weeks), start of device use (Baseline), after 6~     weeks and 12 weeks of device use. Participants' walking will assessed using computerised~     three dimensional motion analysis, which will provide a detailed description of the movements~     (kinematics) of the lower limbs. Participants will also be asked to carry out a 10 metre walk~     and a two minute walk. Both gait analysis and the walking performance tests will be carried~     out with and without an assistive device; apart from their first session where participants~     will only be assessed without their assistive device.~      Participants will be asked to wear an activity monitor for 7 days after each assessment. In~     addition participants will be asked to complete four short standardised questionnaires (MS~     walking scale, MS impact scale (MSIS-29), Fatigue severity score and the Leeds MS Quality of~     life score) at each assessment.~   "
121490|NCT01977274|"~     Research of predictive clinical and biological factors in breast cancer : genomic, proteomic,~     mutation~   "
121491|NCT01977261|"~     A prospective, randomised, controlled trial compared two different techniques of high tibial~     osteotomy with a lateral closing wedge or a medial opening wedge, stabilised by a Puddu~     plate. The clinical outcome and radiological results were examined at one year.~   "
121492|NCT01977248|"~     The SMART Program at Nationwide Children's Hospital is an interdisciplinary social skills~     group that teaches children with autism spectrum disorders (ASD) ages 2-12 the fundamental~     social skills necessary to build and maintain relationships. The manualized curriculum~     addresses skills such as joint attention, eye contact, play, and peer engagement. Currently~     individual goals are set for each child who participates and this is documented in the daily~     treatment note. In order to research group outcomes, the investigators will use parent~     questionnaires (an addition to current clinical practices) to measure changes in behavior~     after each 12 week session for up to one year of treatment. The investigators hypothesize~     that maladaptive behaviors will decrease and adaptive behaviors will increase in children~     with ASD after participation in the SMART program.~   "
121493|NCT01977235|"~     As the gene polymorphism of uridine diphosphate glucuronosyl transferase 1A1(UGT1A1)is~     related to the side effect of diarrhea induced by irinotecan. UGT1A1 gene *28 (6/6 and 6/7)~     and *6 (G/G and G/A) is related to low probability of diarrhea and UGT1A1 gene *28 (7/7) and~     *6 (A/A)is related to high probability of diarrhea. The purpose of this study is to find out~     the efficacy and side effect between two different dosages of irinotecan combined with~     cisplatin scheme in extensive disease-small cell lung cancer with UGT1A1 gene *28 (6/6 and~     6/7)and *6 (G/G and G/A), based on the hypothesis that the UGT1A1 gene *28 (7/7) and *6~     (A/A)is few in the Chinese population and increasing the dose of irinotecan can improve the~     efficacy without increasing the side effect in the patients with UGT1A1 gene *28 (6/6 and~     6/7)*6 (G/G and G/A).~   "
121494|NCT01977222|"~     Mechanisms that typically result in increased cardiac output, such as inotropic support,~     increased heart rate, and decreased afterload, have a blunted effect in Fontan circulation.~     The thoracic pump is a contributor to venous return that has been largely unexplored in~     patients with Fontan physiology. Inspiratory muscle training can improve the performance of~     competitive athletes across a range of sports and can improve quality of life and functional~     capacity in heart failure patients, presumably by reducing inspiratory muscle fatigue and~     possibly by improving peripheral blood flow during exercise. One could surmise that the~     effects of these changes would be particularly important in the Fontan population. The~     investigators propose to study the effects of inspiratory muscle training on exercise and~     pulmonary function parameters in a cohort of adult Fontan patients.~      The investigators hypothesize that a 12-week program of inspiratory muscle training with an~     inspiratory impedance threshold device will improve inspiratory muscle strength and~     endurance, and that this will translate into improved exercise performance in patients with~     Fontan physiology.~   "
121495|NCT01977209|"~     The investigators' experimental study found that gossypol was the natural inhibitor of~     apyrimidinic endonuclease 1 (APE1) and clinical study observed that high expression of APE1~     was relative to the platinum-resistance in non-small cell lung cancer. Thus the purpose of~     this study is to find out whether gossypol can improve the sensitivity of cisplatin-based~     chemotherapy in the non-small cell lung cancer with apurinic apyrimidinic endonuclease 1~     (APE1) high expression~   "
121496|NCT01977196|"~     The objective of this study was to know the safety of DTP/Hepatitis B and Hib/PRP-T vaccine~     and immediate reactions within the first 30 minutes after injection.~   "
122064|NCT01969760|"~     The purpose of this study is to examine the feasibility and acceptability of a family-based~     program to improve physical activity and tobacco outcomes in a small pilot of middle school~     students and their families.~   "
121497|NCT01977183|"~     The purpose of this clinical trial is to study the effects of potato resistant starch on the~     microbiota (microorganisms or bacteria) and short chain fatty acids levels of the gut. Levels~     will be measured and compared between elderly adults and in pre-elderly, adults from the~     general public. A correlation between the use of potato resistant starch and specific~     clinical and quality of life endpoints between elderly adults and in pre-elderly, adults from~     the general public will be studied.~      Hypothesis 1: The investigator hypothesizes that the microbiome in elderly adults (≥70 years)~     is less diverse and more prone to imbalance compared to adults (30-50 years) from the general~     population and that this imbalance of the gut microflora in the elderly adults is partially~     related to inadequate RS in their diet.~      Hypothesis 2: The investigator hypothesizes that ingestion of potato resistant starch of food~     grade quality (MSPrebiotic) will stabilize the gut microbiome (i.e. high~     Firmicutes/Bacteroides ratio)in LTC residents (i.e. similar to that of adults from the~     general population), thereby improving gut health and reducing the risk of diarrhea and/or~     gut infection.~   "
121498|NCT01977170|"~     The objective of this study was to know the safety of Hib/PRP-T vaccine and immediate~     reactions within the first 30 minutes after injection.~   "
121499|NCT01977157|"~     Examination if the bioimpendanz measurement can be used for the determination of the alcohol~     content in human blood.~      Furthermore the blood alcohol content (BAC) will be estimated by an official breathalyzer and~     one blood test.~   "
121500|NCT01977144|"~     The purpose of this study is to assess the impact of Comprehensive Chromosome Screening(CCS)~     on patients with low ovarian reserve in an effort to improve success during in vitro~     fertilization and decrease the time to successful pregnancy.~   "
121501|NCT01977131|"~     The aim of this study was to analyze the safety, pulmonary function, and imaging changes of~     patients with silicosis treated with autologous bone marrow stromal cells with modification~     by hepatocyte growth factor.~   "
121502|NCT01977118|"~     Around 20 per cent of patients with acute pancreatitis develop pancreatic or peripancreatic~     necrosis with or without peripancreatic collection.~      Percutaneous catheter drainage successfully drains the liquefied component of pancreatic~     necrosis while the solid component still remains undrained. This infected solid component of~     pancreatic necrosis is probably responsible for failure of percutaneous catheter drainage~     which demands surgical debridement.~      Streptokinase is a protein secreted by several species of streptococci which can bind and~     activate human plasminogen.~      In the present study investigators plan to instill streptokinase locally in to the~     collections of patients with severe acute pancreatitis via pigtail catheter inorder to~     liquefy the solid necrotic component and analyze whether it hastens the drainage and thereby~     delays or obviates the need for necrosectomy.~   "
121503|NCT01977105|"~     This is a single-group feasibility pilot trial of a peer-based, social media intervention to~     prevent obesity in infants.~   "
121504|NCT01977092|"~     The goal of the study is to see if a Motivational Interviewing Case Management (MICM)~     intervention will improve outcomes for respondents who are on probation or parole, at risk~     for HIV and have recently entered a Sober Living House. The MICM will help respondents access~     needed services, adapt to their new living environment, find and maintain work, address HIV~     risk and treatment, and manage setbacks. The risk for HIV infection among criminal justice~     offenders is significant, as is the need for stable, drug free housing in this population.~     Our aim is to see if the MICM intervention in the context of drug free housing will improve~     health outcomes, reduce recidivism, and increase service utilization for this population.~   "
121505|NCT01977079|"~     Among all patients hospitalized for Threatened Premature Delivery (TPD), the rate of~     premature birth (PB) before 37 weeks is about 42%, which reflects the inability to accurately~     identify patients at high risk of PB. Currently, no clinical or biological marker is~     recognized as the most reliable in predicting the real risk of AP in case of MAP.~      The purpose of this study is to improve the knowledge of predictors of preterm delivery~     compared with conventional blood markers by estimating serum procalcitonin according to~     premature delivery or not in patients hospitalized for preterm labor .~   "
121506|NCT01977066|"~     The purpose of this study is to compare the effects of two specific exercise interventions~     and one standard care control arm on physical functioning.The investigators expect that~     supervised training is most beneficial to the patients. However, they also expect some~     benefit for patients in the home-based training.~   "
121507|NCT01977053|"~     In health care, the phone has emerged as a clinical tool in its own right, especially for the~     development of psychological support to patients and that, in many pathologies. Its potential~     in the development of psycho-social support was quickly identified.~      However, to our knowledge, no prospective, randomized studies have evaluated the impact of a~     telephone call to both the anxiety and the management of side effects of neoadjuvant or~     adjuvant chemotherapy.~      The patient incomplete care by the hospital system and the general practitioner during~     chemotherapy, as well as the lack of information and poor preparation and / or management of~     side effects, are a source of distress and lead to a decrease quality of life for the patient~     and his family.~      We propose to determine on a population of 280 patients, the impact of two phone calls during~     3 first inter-treatment intervals on the overall measure of mood states of the patient and~     his principal caregiver (anxiety, depression, confusion, angry, fatigue, force and~     interpersonal relation). We will also study the gain in quality of life, on anxiety level,~     frequency and severity of toxicities, as well as emotional comfort of the procedure.~   "
121508|NCT01977040|"~     This is a multicenter retrospective observational study of women diagnosed with a vasa previa~     during pregnancy or at delivery who delivered between 2000 and 2012. The study hopes to be~     able to describe techniques utilized to screen for and diagnose vasa previa as well as to~     describe the maternal characteristics and identify potential underlying risk factors that may~     provide a basis for future screening recommendations for vasa previa and treatment protocols.~   "
121509|NCT01977027|"~     Motor learning can be affected by the sensory difficulties that may be experienced as a~     result of a stroke. This study will help us better understand what kinds of sensory~     information can help with the re-learning of grasping with the affected hand despite the~     sensory difficulties produced by the stroke.~   "
129544|NCT01871740|"~     The purpose of this trial is to confirm that enalapril maleate and folic acid tablets is more~     effective in preventing renal function decline among the patients with primary hypertension~     when compared to enalapril maleate.~   "
121511|NCT01977001|"~     MigraineBoxTM is a simple, contoured cooling bath for the head and neck. Effectiveness of~     MigraineBoxTM will be studied in primary headaches in the emergency department. The user~     simply reclines his/her head and neck into this device that has contours that support the~     head and neck. Luke warm water is filled into the MigraineBoxTM before use and then a frozen~     insert is placed inside. This will gradually cool the water surrounding the patient's head~     and theoretically provide headache relief.~   "
121512|NCT01976988|"~     Patients undergoing major colorectal surgery are at increased risk for VTE (deep venous~     thrombosis) compared with patients undergoing other general surgical procedures (Bergqvist et~     al. Dis. Col. Rectum. 2006; 49: 1620-1628.)~      The reported incidence of symptomatic VTE after colorectal surgery is approximately 4% (Monn,~     F. et al. JACS. 216; 2013: 395-401). However, the reported incidence of VTE after colorectal~     surgery in prospectively followed patients managed with perioperative venous~     thromboprophylaxis undergoing screening venography prior to hospital discharge ranges from 9~     to 20% (Bergovist et al. NEJM 346; 2002: 975-980; McLeod et al. Ann. Surg. 233; 2000:~     438-444; ENOXACAN Study group. Brit. J. Surg. 84; 1997: 1099-1103.~      The Surgical Care Improvement Project (SCIP) and the American College of Chest Physician~     (ACCP) guidelines recommend that venous thromboprophylaxis be initiated within 24 hours of~     surgery. However, it is believed that deep venous thrombosis occurs during surgery, rather~     than in the postoperative period, justifying preoperative initiation of venous~     thromboprophylaxis. This practice is accompanied with a theoretically higher risk of bleeding~     complications.~      Currently there is no consensus on the precise timing of VTE prophylaxis after major~     colorectal surgery, as demonstrated by the vague guidelines established by the ACCP and SCIP.~     Current studies on VTE prophylaxis report preoperative initiation of VTE prophylaxis.~     However, majority of surgeons at our institution begin heparin postoperatively given concern~     for bleeding complications with preoperative dosing of heparin.~      The purpose of this study is to prospectively evaluate the incidence of VTE and major~     bleeding complications in patients undergoing major colorectal surgery who are treated with~     preoperative or postoperative venous thromboprophylaxis and to help establish more stringent~     guidelines on the optimal timing of VTE prophylaxis.~   "
121513|NCT01976975|"~     This study aims to investigate reward learning across the mood disorder spectrum and to~     investigate the predictive validity of reward learning for subsequent symptom severity.~   "
121514|NCT01976962|"~     To improve radiation therapy of prostate cancer, the investigators must be able to accurately~     identify the tumour. By using advanced functional imaging techniques available on~     state-of-the-art MRI scanners to clearly show the specific location of the tumour inside the~     prostate, the investigators can use advanced radiation therapy techniques to specifically~     target the tumor and control it with as few radiotherapy clinic visits as possible. This is~     different than current techniques which treat the whole prostate gland to the same dose,~     delivered over 7-8 weeks of daily radiotherapy visits. By increasing the radiation dose to~     the active tumor while still maintaining adequate radiation dose to the rest of the prostate,~     the investigators hope to better control prostate cancer and reduce complications to nearby~     normal tissues.~   "
121515|NCT01976949|"~     It is hypothesized that the treatment group will show greater improvements in quality of life~     and mood disturbance compared to the control group and that greater levels of engagement with~     the intervention materials will be associated with greater improvements in mood and quality~     of life.~   "
121516|NCT01976936|"~     This trial will be a phase 2 randomized safety study in which ischemic stroke patients will~     be randomly assigned within 24 hours of symptom onset to placebo or standard dose lovastatin~     versus short-term high-dose lovastatin 640 mg per day for 3 days. The primary outcome of this~     Phase 2 study will be musculoskeletal and hepatic toxicity, defined by clinical and~     laboratory criteria, with a 3-month follow-up period (± 1 week). Secondary outcomes will~     include neurological outcome (National Institute of Health (NIH) Stroke Scale), functional~     outcomes (Barthel Index), and handicap (modified Rankin scores). Effects on inflammatory~     markers and lipid levels will also be assessed.~   "
121517|NCT01976923|"~     The purpose of this is study is to assess the efficacy of pre-operative intravitreal~     bevacizumab (IVB) (Genentech, South San Francisco CA) in improving visual acuity, reducing~     operative time, complications, intra-operative and post-operative hemorrhage following small~     gauge pars plana vitrectomy (PPV) (23-gauge, 25-gauge or 27-gauge ) compared to small gauge~     PPV (23-gauge, 25-gauge or 27-gauge) alone in eyes with tractional retinal detachment (TRD)~     secondary to proliferative diabetic retinopathy (PDR). Hypothesis: Preoperative IVB may be~     beneficial for membrane dissection in diabetic tractional retinal detachment with minimally~     invasive vitreoretinal surgery (23-gauge transconjunctival sutureless vitrectomy [TSV]). In~     addition, post-operative rebleeding may be decreased.~   "
121518|NCT01976910|"~     DM-CHOC-PEN is a polychlorinated pyridine cholesteryl carbonate that has demonstrated~     antineoplastic activities in human xenograft intracerebrally implanted tumor mouse models,~     acceptable preclinical toxicities in mouse, rat and dog models; and no behavioral cognitive~     impairment/neurotoxicities were noted in mouse and rat models.~      The drug is ready for human use as an soy bean oil/lecithin/glycerin water emulsion, the~     latter which has been documented - chemically and biologically to be stable and safe.~     Patients are currently being enrolled and treated with the protocol.~      Patients with advanced cancer, with or without central nervous system involvement will be~     eligible for enrollment, providing the required blood and other eligibility requirements are~     met.~   "
121519|NCT01976897|"~     The main objective of this study is to evaluate the relationship between the angle of knee~     flexion in a supine position with joint relaxation (DDPD) and the maximum interface pressure~     at the heel area (PtAl).~   "
121520|NCT01976884|"~     Immunosuppression is the leading cause of death in septic patients. Neutrophils are classical~     components of innate immunology, but recent studies showed that neutrophils might display~     antigen presenting function and inhibit lymphocyte proliferation by expressing programmed~     cell death 1 ligand 1 (PD-L1). Whether neutrophils express PD-L1 and its role in~     immunosuppression during sepsis remain unclear.~   "
121521|NCT01976871|"~     The primary objective is to demonstrate safety and tolerability of switching patients with~     Restless Legs Syndrome (RLS) from an oral dopamine agonist to rotigotine.~      As a secondary objective, the investigators will evaluate control of RLS symptoms on~     rotigotine compared to the prior oral regimen.~   "
121522|NCT01976858|"~     Polyethylene Glycol Loxenatide (PEX168) is a new human glucagon-like peptide 1 (GLP-1)~     analogue that created on the basis of the Exenatide and modified by polyethylene glycol~     (PEG).~      This study aims to evaluate the PK, PD and safety by 8-week continuous treatment of PEX168.~   "
121771|NCT01973595|"~     The purpose of this study is to determine whether incorporating almonds into the diets of~     families with young children will induce beneficial changes in gastrointestinal function, the~     fecal microbiota profile, and immune and inflammatory processes of the adults and children~     resulting in improved quality of life. The investigators anticipate finding an increase in~     beneficial bacteria, improved intestinal function, and decreased inflammation during the~     almond intervention.~   "
121523|NCT01976845|"~     The purpose of this research is:~      To evaluate the sedative (reduces irritability or agitation), anxiolytic (reduces anxiety),~     and amnesic (produces temporary lack of recall) effects of propofol or midazolam when~     administered for preoperative medication (before administration of drugs that will put~     patient to sleep) in comparison to placebo. This study is to test whether the use of the~     pre-anesthesia medication measurably reduces anxiety in comparison to receiving no~     pre-anesthesia medication prior to orthopedic procedures.~      To assess the effect of propofol in comparison to placebo and midazolam on the ability to~     recall (memory of):~        -  when the doctor places the mask on patient's face prior to going to sleep~        -  recall of 2 pictures~        -  on your satisfaction with the anesthesia as well as postoperative side effects in~          post-anesthesia care unit (PACU) e.g., nausea ,vomiting and sedation.~   "
121524|NCT01976832|"~     This study intends to use music and movement (MWM) to reduce anxiety and behavioral symptoms~     of people with early dementia (PWD) and their family carers in the community. It also aims to~     examine whether MWM can enhance the sleep quality of PWD and their family caregivers and~     promote their well-being.~      This is a mixed methods study with the quantitative paradigm being the main research~     approached used. The quantitative arm will be a randomized controlled trial (RCT). The~     qualitative arm will adopt a naturalistic approach through interviewing for data collection.~     Recruited subjects from the community centres of non-government organizations (NGOs) will be~     randomly allocated to the intervention and control group.~      The outcome measures of the PWD will include Rating Anxiety in Dementia (RAID), Geriatric~     Depression Scale (GDS), Neuropsychiatric Inventory Questionnaire (NPI-Q), Pittsburgh Sleep~     Quality Index (PQSI), Quality of Life - Alzheimer's Disease (QOL-AD), Mini-Mental State~     Examination (MMSE), Revised Life Event Scale (RLES), Modified Brathel Index (MBI) and~     Non-pharmacological Therapy Experience Scale (NPTES), whereas the outcome measures of the~     family caregivers will be Patient Health Questionnaire 9 (PHQ-9), Generalized Anxiety~     Disorder 7 (GAD-7), Zarit Burden Scale (ZBD), Pittsburgh Sleep Quality Index (PSQI), Reverse~     Life event Scale (RLES), and World Health Organization Quality of Life-BREF (WHOQOL-BREF).~      To address the research questions, data will be collected at baseline (T0), immediately~     post-intervention at 8-weeks (T1), and 8 post-intervention (T2). The qualitative arm of this~     study will contribute to the understanding of issues and effects of MWM as an intervention.~     Its finding will complement the results obtained from the RCT.~   "
121525|NCT01976819|"~     This clinical investigation addresses the performance of a re-designed The current study aims~     to investigate the next version of the TW speaking valve, in combination with both a 15mm and~     22mm HME cassette.~   "
121526|NCT01976806|"~     The purpose of this study is to determine whether docosahexaenoic acid (DHA) is effective in~     the treatment of periodontitis in adults.~   "
121527|NCT01976793|"~     This Non-Interventional Study (NIS) is intended to evaluate the duration of treatment with an~     initial antidepressant taken as monotherapy in patients in whom treatment was changed because~     of suboptimal response at physician's discretion. This will address unmet medical needs of~     patients with a depressive episode related to RDD (ICD-10, Version 2010), who have failed to~     respond adequately to initial treatment with an antidepressant and contribute to an~     understanding of the usual approaches that physicians adopt to monitor initial treatment~     efficacy in RDD (Recurrent Depressive Disorder). The study will also focus on second-line~     therapy in hard to treat patients, describing the different pharmacotherapeutic strategies.~   "
121528|NCT01976780|"~     This study aims to assess the degree of artemisinin resistance in adult and pediatric~     subjects presenting with uncomplicated falciparum malaria in Western Kenya. The study~     treatments will be Artemether Lumefantrine (AL) and Artesunate Mefloquine (ASMQ).~   "
121529|NCT01976767|"~     Cross-sectional study to characterize cohorts of subjects with asthma and healthy controls in~     terms of clinical features, physiological measurements and non-invasive measurement of~     biomarkers and develop phenotype handprints for adults with severe asthma~   "
121530|NCT01976754|"~     Septic patients in Intensive Care Unit always need mechanical ventilation and~     conscious-sedation. But the recommended dose 0.2-0.7μg/kg/h could not run well because of~     wide range. The purpose of this study is to find the effective dose of dexmedetomidine adult~     septic patients of mechanical ventilation .~   "
121531|NCT01976741|"~     -  This is the first study where BAY1163877 is given to humans. Impact of the study is to~          evaluate if patients with advanced solid cancers show advanced clinical benefit under~          the treatment with the pan FGFR inhibitor. Patients (all comers) will receive the study~          drug treatment in a dose-escalation scheme (no placebo group) to determine the safety,~          tolerability and maximum tolerated dose (MTD) of BAY1163877. The relative~          bioavailability of liquid service formulation and tablets will be determined.~        -  After the MTD is defined patients with solid tumors (all comers), lung cancer (lung~          adenocarcinoma & squamous non-small cell lung cancer), head and neck cancer or bladder~          cancer will be enrolled according to their FGFR expression profile (biomarker~          stratification).~        -  The study will also assess the pharmacokinetics, biomarker status, pharmacodynamic~          parameters and tumor response of BAY1163877.~        -  BAY1163877 will be given twice daily as oral application. Treatment will be stopped if~          the tumor continues to grow, if side effects, which the patient cannot tolerate, occur~          or if the patient decides to exit treatment.~   "
121532|NCT01976728|"~     To compare the ovulation rate in women with primary amenorrhea with hypogonadotropic~     hypogonadism following pulsatile gonadotropin-releasing hormone (GnRH) treatment using the~     OmniPod pump versus placebo~   "
121546|NCT01976546|"~     Tracheal intubation with videolaryngoscopes have been widely studied, and is now often used~     in the management of difficult airways.~      Videolaryngoscopes with angulated blades can improve laryngeal view, however this does not~     always match with a higher intubation succes. To adress this matter the aim of this study is~     gathering experience with intubation with mcgrath videolaryngoscope and a blade-shape~     intubation foreceps (Boedeker intubation foreceps, Karl Storz, Germany).~      The hypothesis is that intubation with this combination is easy and can be a good alternative~     when using the McGrath videolaryngoscope in patients with predictors of difficult airway.~   "
121547|NCT01976533|"~     This is a historical cohort study with retrospective collection of data comprising all Nordic~     patient's diagnosed with Eisenmengers syndrome in the period 1977 through 2011. The goal is~     to determine prognostic factors for mortality and morbidity.~   "
121533|NCT01976715|"~     Background:~      - The human immunodeficiency virus (HIV) causes acquired immune deficiency syndrome (AIDS).~     Combination antiretroviral therapy (ART) drugs treat HIV infection. They generally decrease~     the amount of HIV virus in the blood (called viral load) to very low levels. This happens~     only if the drugs still fight HIV and if taken every day exactly as prescribed. When not~     taken as directed, or if the ART drugs are not strong enough, the virus can become resistant~     to them, and the ART will not work to control the virus. Researchers want to know how to~     control HIV in people who can t lower their viral load with their current ART drugs.~      Objective:~      -<TAB>To better control HIV in people who can t get a lower viral load even with ART drugs~     and to learn more about why the HIV is not under control.~      Eligibility:~        -  People at least 14 years old and with HIV.~        -  People who have been on at least two combinations of ART drugs (including current ART).~        -  People whose last two viral loads were greater than 1,000 copies/mL.~      Design:~        -  Participants will be screened with medical history, physical exam, and blood tests.~        -  Participants will then have a baseline visit. They will have another physical exam,~          blood tests, plus answer questions about what they know about HIV and ART, and how they~          take their ART.~        -  Participants will arrange to stay in the NIH hospital for 7 8 days.~        -  They will take their medications as usual. At the time to take the ART drugs, they will~          have to ask a nurse to bring them. If they forget, the nurse will bring them.~        -  Participants will meet with a doctor, pharmacist, social worker and nurse to discuss~          ways to help participants remember to take their drugs.~        -  Participants will have blood drawn about every other day.~        -  Researchers will study the test results. Some participants will be put on different ART~          drugs. If that happens, participants will have another NIH hospital stay for 7-8 days.~        -  Participants will have 4 follow-up visits over 12 weeks, then every 3 months for 2 years~          or more.~   "
121534|NCT01976702|"~     This 5 year study, targeting Pregnant Drug Abusers in treatment, is a randomized trial of an~     Enhanced Behavioral Skills Training (E-BST) intervention compared to a time-and~     attention-matched Health Promotion Comparison (HPC) condition. E-BST is an adaptation of the~     original BST intervention (Eldridge, St. Lawrence et al., 1997), designed to strengthen~     relationship-based social competency skills of the original BST that were crucial in~     sustaining adherence to protective behavior.~   "
121535|NCT01976689|"~     New-onset diabetes (NODAT) after solid organ transplantation is an important clinical~     challenge associated to increased risk of cardiovascular (CV) events. In end-stage renal~     disease (ESRD) patients, the impact of arterial stiffness on all-cause and CV mortality has~     been clearly documented. Arterial stiffness has a pivotal role in the genesis of high blood~     pressure (SBP), increased left ventricular hypertrophy (LVH), and consequently CV mortality.~     Both LVH and arterial stiffness are independent determinants of CV disease in patients with~     ESRD. The aim of this study is to evaluate the relationship between post-transplant new-onset~     diabetes and arterial stiffness and left ventricular mass index (LVMI) in kidney transplant~     recipients.~   "
121536|NCT01976676|"~     Recent data indicates that 5 methyltetrahydrofolate (5MTHF) can reduce serum homocystein~     level more efficiently than folic acid. On the other hand, folic acid is currently an~     important part of treatment in idiopathic recurrent abortion. There is no study comparing the~     effectiveness of these supplements in the treatment of recurrent abortion. The aim of this~     study is to compare the efficiency of these two agents in the treatment of recurrent~     abortion. In this study, patients with idiopathic recurrent abortion, referring to Avicenna~     clinic will be randomly allocated into two groups of those taking either folic acid (5 mg) or~     5 MTHF (5mg) from 8 weeks prior to conception until the 20th week of pregnancy. The serum~     level of folate, homocystein, and ongoing pregnancy will be analysed and compared in the two~     groups.~   "
121537|NCT01976663|"~     A prospective, multicenter, within-subject controlled study of the safety and effectiveness~     of JUVÉDERM VOLIFT® XC versus Control for the correction of moderate to severe nasolabial~     folds (NLFs).~   "
121538|NCT01976650|"~     This study is a Post-Market Surveillance study in Korea to evaluate the safety and efficacy~     of dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant used to treat Branch Retinal Vein~     Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior~     segment of the eye in clinical practice.~   "
121539|NCT01976637|"~     Leg compression is considered the basic treatment for superficial vein thrombosis (SVT).~     However, its use is more or less based on subjective experience while scientific evidence for~     its efficacy is lacking. There is one uncontrolled trial reporting improvement of clinical~     symptoms when patients with SVT were treated with fixed compression bandages.~      This study evaluates the efficacy of compression stockings (23-32 mmHg) in the treatment SVT~     of the legs. The investigators hypothesis is that compression treatment is superior to no~     compression in alleviating disease related clinical symptoms.~   "
121540|NCT01976624|"~     This study is a Post-Marketing Surveillance study to evaluate the safety and efficacy of~     bimatoprost/timolol (Ganfort®) Ophthalmic Solution to treat open-angle glaucoma or ocular~     hypertension in Korea.~   "
121541|NCT01976611|"~     This study is a Post-Marketing Surveillance study in Korea to evaluate the safety and~     efficacy of botulinum toxin Type A to treat Chronic Migraine in clinical practice.~   "
121542|NCT01976598|"~     To explore the optimal stimulation parameters and locations for sub-perception programming in~     patients with previously implanted spinal cord stimulation systems for the treatment of~     chronic back and/or leg pain.~   "
121543|NCT01976585|"~     Our recent trials combining local radiotherapy with intratumoral administration of TLR~     agonists - referred to as 'in situ vaccination' - for patients with low-grade lymphoma~     demonstrated safety, induction of anti-tumor CD8 T cell responses and partial and complete~     remissions of patients' non-irradiated sites of disease with complete remissions lasting from~     months to more than three years.~      This iteration of the in situ vaccine approach builds on our prior work in ways that should~     improve its efficacy, by adding Flt3L and changing the toll-like receptors (TLR) agonist to~     poly-ICLC -an optimal TLR agonist for the type of dendritic cells (DC) recruited by Flt3L.~     The vaccine is thus in 3 phases:~        1. intratumoral Flt3L administration recruits DC to the tumor~        2. low-dose radiotherapy to release tumor antigens~        3. intratumoral poly-ICLC administration activates tumor-antigen loaded DC~   "
121544|NCT01976572|"~     The primary objective is to assess the effects of colestilan on the pharmacokinetic profile~     of candesartan cilexetil when administered at the same time as, 1 hour before, and 3 hours~     after the first daily dose of colestilan administered at doses of 5 g three times daily~     compared to administration of candesartan cilexetil alone, in healthy subjects.~   "
121545|NCT01976559|"~     This research is being done to determine the accuracy of two noninvasive methods of measuring~     the pressure of the spinal fluid, also known as intracranial pressure (ICP).~   "
121548|NCT01976520|"~     This Phase I trial studies the safety and efficacy of vaccine therapy in treating patients~     with previously untreated chronic lymphocytic leukemia. Liposome-based vaccines containing an~     extract of a person's cancer cells and the immunostimulant interleukin-2 may help the body to~     build an effective immune response to kill cancer cells.~   "
121551|NCT01976481|"~     Our study aims to clarify the impact of the use of a standard sunbed according to new EU~     guideline EN 60335-2-27 and possibly discount the positive effects of tanning beds. We plan~     to investigate the serum elevation of 25(OH)D under sunbed use, respecting the new~     recommendations for the exposure plan for different skin types according to EN 60335-2-27.~      The use of a sunbed will be compared to a control group not using a sunbed in the observation~     period.~        -  Trial with medical device~   "
121552|NCT01976468|"~     The investigators hypothesize that a low number of SCC in OTR will metastasize.~   "
121553|NCT01976455|"~     The purpose of this study is to develop a novel, non-invasive method that will provide~     personalized feedback during dietary interventions as a marker for compliance.~   "
121554|NCT01976442|"~     The purpose of this study is to determine whether a novel standard of care protocol, washing~     red cell and platelet transfusions for younger patients with acute leukemia, has yielded~     improved clinical outcomes at Strong Memorial Hospital (Rochester, New York, USA). This~     standard of care was implemented based upon an earlier randomized trial (BMC Blood Disorders.~     2004 Dec 10;4(1):6) The comparator will be historical controls from the medical literature.~   "
121555|NCT01976429|"~     This study will determine if newly developed and more standard tests of Eustachian tube~     function can identify those persons who have ear pain (barotrauma) or develop middle-ear~     inflammation and/or fluid (barotitis) when they are exposed to rapid changes in air pressure~     as, for example, during airplane flights or scuba diving. Up to 150 adults and children~     (10-50 years old) who fly or dive at least 1-2 times and experience ear pain or develop~     middle-ear fluid during those activities and approximately 60 adults and children who fly or~     dive but do not experience these problems will undergo Eustachian tube function testing~     during simulated flight and diving.~   "
121556|NCT01976416|"~     Multiple studies have shown that hydroxyurea has clinical efficacy in preventing acute~     painful episodes and reducing the need for blood transfusions in children with sickle cell~     anemia (SCA), but no study has been conducted in malaria endemic regions of sub-Saharan~     Africa, the areas with the most children with SCA.~      The primary goal of this study is to investigate the safety and efficacy of hydroxyurea for~     children with SCA in a malaria endemic region within sub-Saharan Africa.~   "
121557|NCT01976403|"~     The main objective of this randomized controlled trial is to evaluate the effect of an~     intervention formed as a pain booklet provided to patients at discharge from hospital~     following cardiac surgery.~      The primary objectives are to:~        1. Develop and implement a pain booklet to improve pain management after cardiac surgery~        2. Evaluate the effect of the pain booklet compared to a group of patients given usual care~   "
121558|NCT01976390|"~     This study is being done to compare the effectiveness and safety of two different kidney~     transplant immunosuppression drugs, Zortress (the study drug) and Rapamune (which is used in~     the current standard immunosuppression regimen).~   "
121559|NCT01976377|"~     Head and neck squamous cell carcinoma(HNSCC) is the fourth common malignancy in Taiwan. It~     accounts for 5.8% of all cancers and causes 2,463 deaths per year. Aberrant glycosylation is~     the hallmark of most human cancers, including HNSCC, and affects many cellular properties.~     This study is aimed at exploring the role of mucin glycosylating enzymes in HNSCC.~   "
121560|NCT01976364|"~     This is a Phase 3, long-term open-label extension study to evaluate the safety, tolerability~     and efficacy of tofacitinib in subjects with active PsA who have previously participated in~     randomized studies of tofacitinib for this indication.~      This study will include a sub-study to evaluate the efficacy, safety and tolerability of~     tofacitinib 5 mg BID administered as monotherapy after methotrexate withdrawal compared to~     tofacitinib 5 mg BID continued in combination with methotrexate. The sub-study will be~     available to subjects who have completed at least 24 months of participation in the~     open-label extension study and meet eligibility criteria for the sub-study.~   "
121561|NCT01976351|"~     Imaging enhanced endoscopy can improve the efficacy of screening of Barrett's esophagus and~     predict its invasiveness. There is potentially molecular change over the Barrett's esophagus~     in this Chinese population.~      To evaluate the efficacy of imaging enhanced endoscopy for screening of Barrett's esophagus~     and evaluation of invasiveness~   "
121562|NCT01976338|"~     Provided efficacy and safety data on intravitreal injections of ranibizumab 0.5 mg in~     patients with visual impairment due to macular edema secondary to BRVO~   "
121563|NCT01976325|"~     BRIEF SUMMARY~      Canadians often visit areas with malaria where the preventative drug chloroquine no longer~     works.~      This leaves Canadians with the choice to use three different drugs to prevent malaria -~     atovaquone-proguanil, doxycycline, or mefloquine. There are more than 400 cases of malaria~     reported in Canada each year, a few which result in death. These cases mainly occur in people~     who do not take malaria pills as directed.~      Investigators have developed the Ottawa Malaria Decision Aid (OMDA), which is a bilingual~     (English and French) resource used to support malaria prevention decision-making. The OMDA~     contains plain language, fact-based information and helps individuals to reflect on their own~     values and beliefs so that they can make the best decision for their situation.~      In this randomized control study, the investigators will attempt to find out if using the~     OMDA before visiting a travel clinic affects decisional conflict and the way pills are taken.~     Consenting travellers will be assigned to standard care or standard care plus the malaria~     decision aid. Both groups will complete three questionnaires before and after travel to look~     at the impact on decisional conflict, preparation for decision-making, decisional regret and~     pill taking behaviour.~      Travelers' malaria can be prevented. It is our hope that by using different methods of~     presenting information, specifically by utilizing the OMDA, there will be an increase in~     adherence to appropriate malaria prophylaxis which will ultimately result in a decrease in~     malaria cases that arrive in Canada. This will translate into a decreased use of health care~     dollars and unnecessary deaths.~      The Objectives of this study are to evaluate whether the malaria decision aid can be~     integrated into the pre-travel consultation process and can:~        -  improve a traveller's knowledge of malaria and prevention strategies;~        -  improve a traveller's preparation for decision-making;~        -  decrease decisional conflict; and~        -  affect levels of adherence to prescribed malaria chemoprophylaxis.~      The hypotheses of this study are that:~        1. A decision aid will improve the quality of decision-making about malaria~          chemoprophylaxis by decreasing decisional conflict and increasing knowledge about~          malaria and malaria pills.~        2. Better decision quality will result in a greater level of adherence to prescribed~          malaria chemoprophylaxis.~   "
121564|NCT01976312|"~     Provide efficacy and safety data on intravitreal injections of ranibizumab 0.5 mg in patients~     with visual impairment due to macular edema secondary to CRVO~   "
121565|NCT01976299|"~     The Osprey Medical AVERT System is indicated to reduce contrast media (CM) exposure to the~     kidneys during percutaneous coronary procedures thereby reducing the risk of contrast induced~     nephropathy (CIN).~   "
121566|NCT01976286|"~     The purpose of this study is to find out the safety and effectiveness of Glycolic Acid~     Chemical Peels compared to Salicylic Acid Chemical Peels for the treatment of melasma.~   "
121567|NCT01976273|"~     The purpose of this study is to find out the safety and effectiveness of 1064 Q-Switch Laser~     Therapy compared to Glycolic Acid Chemical Peels for the treatment of melasma.~   "
121571|NCT01976221|"~     The primary outcome in this study is more appropriate and comprehensive referrals and a more~     seamless and smoother referral process with reduced workload for both partners. The referral~     rates may be reduced by higher awareness of non-prioritized medical conditions. The use of~     priority setting and waiting time according to the national prioritization guidelines can~     give a higher correlation between GPs and hospital consultants about priority setting and~     waiting time. In this study we will evaluate the effect of a multifaceted educational~     intervention (a training program in priority setting) on the appropriateness and~     comprehensiveness of referrals in terms of the agreement on priority setting and waiting time~     between GPs and hospital consultants.~   "
121572|NCT01976208|"~     The primary purpose is to evaluate the safety and efficacy of recombinant humanized anti-IgE~     monoclonal antibody injection in patients with allergic asthma.~   "
121573|NCT01976195|"~     The project was undertaking by Qilu Hospital of Shandong University in China. In order to~     report the efficacy and safety of thalidomide combining with high-dose dexamethasone for the~     treatment of adults with primary immune thrombocytopenia (ITP), compared to conventional~     high-dose dexamethasone mono-therapy.~   "
121574|NCT01976182|"~     LGL leukemia represents a rare subtype of chronic T or NK lymphoproliferative disorders. It~     is an indolent disease, the main hematological or autoimmune complications lead to a~     treatment in more than 60% of patients.~      Investigators set up at the University Hospital of Rennes, a database of more than 300~     patients with LGL leukemia from major French services that support this disease, and~     published in 2010 the largest series of patients in the world (n = 229). However, the limited~     heterogeneity and retrospective data collected, as all previously released, makes it~     difficult the proposal of consensual treatment options. If first and second line treatments~     are based on the use of immunosuppression with methotrexate, cyclophosphamide, or cyclosporin~     A, no molecule has proven superiority over others. Methotrexate and cyclophosphamide are~     mainly used in the first line. Invetigators just have in the literature data on about 100~     patients treated with either of these drugs. Combining the results of our series with those~     in the literature, invetigators estimate the respective overall response rate (RG) and~     complete response rate (CR) in 55% and 30% for methotrexate, and 60% and 50% for~     cyclophosphamide.~      Thus, there are four objective in this study :~        1. to compare the respective efficacies of methotrexate and cyclophosphamide when~          administered as first-line therapies in patients suffering from T/NK LGL leukemia with~          severe neutropenia or neutropenia associated with infections, and/or anemia requiring~          transfusions, and/or auto-immune associated disease~        2. to evaluate the percentage of patients refractory to methotrexate or cyclophosphamide~          for which a second line treatment is efficacious~        3. to explore, in case of non-response to the first-line therapy, the efficacy of~          ciclosporine A, the comparison being performed with the treatment which was not~          administered in the first-line therapy~        4. to evaluate the response rate according to the phenotypic subtype of LGL leukemia.~   "
121575|NCT01976169|"~     Standard of care:~      Treatment with Trastuzumab~      Experimental:~      21-Day Cycle of Combination therapy with T-DM1 intravenously on Day 1 and oral PD-0332991 on~     Days 5-18~      Study Design and Methodology:~      This is a phase 1B inter-patient dose escalation study of PD-0332991 in combination with~     T-DM1 in patients with recurrent or metastatic HER2-positive breast cancer after prior~     trastuzumab or other HER2-directed therapies.~      The subjects will be administered T-DM1 by intravenous infusion at 3.6 mg/kg for 90 minutes~     on day 1 of each 21 day cycle. Infusion timing may vary from 30-90 minutes depending on how~     well the subject tolerates the treatment.~      A standard 3+3 trial design will be used for PD-0332991 dose escalation cohorts.The dosing of~     PD-0332991 will be divided into 3 cohorts, the subjects will receive PD-0332991 on days 5-18~     of each 21 day cycle.~      Cohort 1 : PD-0332991 - 100 mg daily (oral) Cohort 2 : PD-0332991 - 150 mg daily (oral)~     Cohort 3 : PD-0332991 - 200 mg daily (oral)~      The 3+3 design entails that if one patient out of the first three patients has a DLT, up to~     three additional patients will be entered at that dose level~      Treatment cycles will continue until disease progression or withdrawal from study.~   "
121576|NCT01976156|"~     The aims of this project are to determine if dietary supplementation with NOPE-EGCG~     (PhosphoLeantm, 30mg NOPE+20mg EGCG per capsule) can:~        -  rescue striatal function,~        -  increase adherence to a diet,~        -  reduce weight-gain after a diet,~        -  improve performance on impulsivity, go/no-go tasks, and negative outcome learning, and~        -  shift fat and sweet preference in overweight/obese human subjects in a double-blind~          cross-over design.~   "
121577|NCT01976143|"~     The purpose of this research study is to evaluate the effect of NKTR-102 on the QT/QTc~     interval in patients with advanced or metastatic solid tumors~   "
121578|NCT01976130|"~     Study hypothesis:~      Chronic Obstructive Pulmonary Disease (COPD) patients with chronic bacterial colonization~     have lower levels of mucins and antimicrobial peptides in their airways~   "
121579|NCT01976117|"~     Hypothesis: A commercial e-nose (Cyranose 320) is able to detect specific breathprints from~     patients with COPD and bacterial infection~   "
121580|NCT01976104|"~     This is a global, multicenter, randomized, double-blind, placebo-controlled, parallel group~     study using avatrombopag to treat adults with thrombocytopenia associated with liver disease.~     The study will evaluate avatrombopag in the treatment of thrombocytopenia associated with~     liver disease prior to an elective procedure to reduce the need for platelet transfusions or~     any rescue procedure for bleeding due to procedural and post-procedural bleeding~     complications. Participants will be enrolled into 2 cohorts according to mean baseline~     platelet count and, within each baseline platelet count cohort will be further stratified by~     risk of bleeding associated with the elective procedure (low, moderate, or high) and~     hepatocellular carcinoma (HCC) status (Yes or No).~   "
121581|NCT01976091|"~     Dose escalation study of self-complementary (sc) AAVrh74.tMCK.hSGCA delivered to single leg~     (low dose n=2) and bilaterally (n=6) via a major lower limb artery to the whole lower limb of~     limb girdle muscular dystrophy type 2D (LGMD2D; alpha-sarcoglycan deficient) patients.~   "
121603|NCT01975805|"~     Currently there are no published studies comparing the efficacy of Chloraprep and~     povidone-iodine in decreasing postoperative- wound infection in cesarean sections. However,~     there have been studies involving other types of surgery that have compared the efficacy of~     different types of preoperative cleansing agents in preventing postoperative wound infection.~     These studies have shown that controversy exists over which antiseptic skin preparation is~     the most effective for preventing postoperative surgical wound infections. The standard of~     care at Los Angeles County Hospital for preoperative skin antiseptic in cesarean sections is~     povidone- iodine 10% (betadine), however many other hospitals have made the transition to~     using Chloraprep. In an attempt to improve on the current standard of care, we propose a~     quality improvement prospective randomized study to compare the difference in postoperative~     wound complications with the use of povidone- iodine and Chloraprep as a preoperative~     antiseptic in cesarean sections. We hypothesize that Chloraprep will be better than Betadine~     at reducing the incidence of positive bacterial cultures following cesarean sections.~   "
121582|NCT01976078|"~     The death rate in children from the invasive fungal infection called aspergillosis is more~     than 50%. Voriconazole is the first-line therapy for this infection. In a previous~     publication the investigators have shown a highly significant relationship between~     voriconazole plasma concentrations and survival. However, voriconazole dosing is currently~     poorly established, and plasma drug exposure varies between children by 400% or more, even~     after intravenous dosing. The objective of this study is to investigate the reasons for this~     variability in voriconazole pharmacokinetics (PK).In two studies, the investigators will~     enroll 80 children/adolescents receiving oral or intravenous voriconazole, divided by age~     under 2 years (n=15), and 2-18 years (n=65). From each patient the investigators will collect~     the following: 1) a blood sample for detection of several genetic changes known to affect~     drug metabolizing enzyme (DME) activity; 2) up to 9 blood samples after a voriconazole dose~     for measurement of voriconazole (PK sampling); 3) follow-up samples after each PK sampling~     visit if necessary to adjust the dose so that voriconazole concentrations in the blood are~     satisfactory (known as therapeutic drug monitoring or TDM). At the time of the voriconazole~     dose prior to the PK sampling, we will also give single IV or oral (corresponding to the~     route of voriconazole administration) low doses of esomeprazole (an antacid), midazolam (a~     sedative), and ranitidine (an antacid) as a cocktail to test or probe DME activity. All of~     these medications are used commonly in children already. The investigators will estimate DME~     activity or phenotype using ratios of probe drug metabolite to parent drug concentrations,~     while simultaneously quantifying the amount of DME genetic material (mRNA) and protein in~     white blood cells. The investigators will test associations between DME activity, mRNA,~     protein, voriconazole PK, age, sex, and degree of illness. The investigators will also use a~     computer program to integrate all these data to develop a comprehensive model that will~     predict blood concentrations of voriconazole in children of all ages, as well as assist~     physicians and pharmacists to dose voriconazole more accurately.The total study duration for~     each subject will be until after the TDM follow up visit, generally about one week.~   "
121583|NCT01976065|"~     This multi-center exploratory clinical trial is a randomized trial designed to test whether a~     regenerative endodontic procedure using tissue engineering principles (REGENDO), or a~     revascularization (REVASC) endodontic procedure, in comparison to standard apexification~     treatment using a mineral trioxide aggregate barrier (apexification; APEX), produces a~     significantly better composite clinical outcome for the treatment of immature permanent teeth~     with pulpal necrosis.~   "
121584|NCT01976052|"~     Potential biomarkers for obstructive sleep apnea (OSA), and full genomic screening will be~     evaluated and correlated to the degree of OSA and to effect of CPAP-treatment measured by~     polygraphy.~   "
121585|NCT01976039|"~     Professionals working in polluted areas may present increased clinical airways symptoms and~     dysfunction. Rhinopharyngeal retrograde clearance (RRC) has been used to improve mucus~     clearance in infants with bronchitis and bronchiolitis, and instillation the nasal cavity~     with saline has been used to reduce nasal inflammation in rhinitis and sinusopathies. The aim~     of this study was to assess the effects of RRC and RCC combined with saline (RRC+S) on nasal~     mucociliary clearance (MCC), mucus surface property, cellularity and airways symptoms in~     professional motorcyclists.~   "
121586|NCT01976026|"~     The purpose of the DIVERT study is to provide a prudent, controlled clinical context for the~     use of flow diversion, a promising option of yet unproven benefit, in the care of patients~     with acute blood blister-like and dissecting intradural aneurysms. Hence DIVERT is a simple,~     multicenter, randomized trial integrated into daily practice. DIVERT addresses the clinical~     dilemma of whether the use of PED FD truly is a safe and effective alternative to best~     standard treatment, defined as conventional methods of treatment or in some cases,~     observation. Selection criteria are few, to facilitate the recruitment of most affected~     patients confronted with these difficult aneurysms that their physician judges suitable for~     PED FD. The trial does not obstruct clinical care, does not include extra tests or risks~     beyond what is necessary and proven beneficial. Endpoints are simple, clinical, meaningful,~     valuable and resistant to bias. Follow-up visits and tests are routine', imposing no extra~     burden on clinical transactions. Data is collected in simple case-report forms filled by~     physicians.~   "
121587|NCT01976013|"~     Up to now, only data about early and single coagulation screening exist in extreme low birth~     weight infants (ELBW) infants. In neonatal practice, coagulation abnormality in preterm~     babies is primarily investigated by measuring prothrombin time (PT). In fact, FVII activity,~     which is an important determinant of PT, is strongly associated with bleeding risk. Thus, a~     method to measure PT with small volume samples (10μL) provides the possibility for serial~     monitoring even in ELBW infants (CoaguChek®XS, Roche Diagnostics, Vienna, Austria)).~     Substitution of fesh frozen plasma seemed beneficial in ELBW infants and first trials with~     rFVII revealed promising results in this patient population. Thus, coagulation monitoring~     might lead to early and adequate therapy and therefore to a better outcome. The investigators~     hypothesize that ELBW infants (<1000g birth weight) with primary severe prolongation of~     prothrombin time or development of severe prothrombin prolongation during sequential~     monitoring may have more frequent and more severe bleeding incidents (Intraventricular~     haemorrhage and pulmonary haemorrhage). The investigators aim to explore whether monitoring~     of PT can predict bleeding events in ELBW children.~   "
121588|NCT01976000|"~     Laparoscopic colorectal surgery has been widely accepted worldwide; however, despite the~     well-known benefits and comparable oncological outcomes, it is still limited by a lack of~     tactile sensation and a reduced operative field view. In addition, the inconsistency in the~     number and course of the mesenteric vessels significantly influences the learning curve with~     30 to 70 cases required for proficiency. To overcome these limitations, the vascular anatomy~     can be mapped using CT-angiography, and the images can be processed with rendering software~     to reconstruct a three-dimensional model of the mesenteric vessels. The aim of this study was~     to assess the influence of visualizing the three-dimensional vascular anatomy on the learning~     curve for laparoscopic colorectal surgery.All patients who underwent laparoscopic left or~     right hemicolectomies between January 2012 and January 2014 were evaluated for inclusion in~     this study. To assess the influence of preliminary knowledge of colonic vascular anatomy on~     the learning curve, we considered 2 groups of two surgeons with different levels of~     experience. In the first group (group A), the surgeons were able to view 3D reconstructions~     before and during the surgery, while the surgeons in Group B were only able to view the 3D~     reconstructions after surgery.~   "
121589|NCT01975987|"~     This study is designed to identify patients' features predictive of successful intubation~     using the Bonfils fiberscope.~      Our hypothesis is that some patients' characteristics are predictors of successful intubation~     with the Bonfils fiberscope.~   "
121641|NCT01975311|"~     The purpose of this study is to determine if a lower back treatment would change the knee~     pain intensity and the level of functional activities as well as the muscle activities in~     people with anterior knee pain. The investigators hypothesized that the lower back treatment~     may change the hip and knee muscle activities as well as reduce the knee pain intensity and~     improve the functional activities in people with anterior knee pain.~   "
121590|NCT01975974|"~     Obtaining peripheral vascular access in medical patients is a necessary procedure for many~     healthcare providers. Peripheral vascular access is traditionally performed using palpation~     or visual inspection to identify appropriate points of entry in the vasculature after which a~     needle and catheter are threaded through the skin and surround fascia into the vessel of~     interest. This procedure, one of the most common procedures in the medical field including~     both artery and vein access, is not 100% successfully attempted. Operator skill heavily~     influences peripheral vascular cannulation. (Frisch et al. 2013) However, certain patient~     populations have difficult peripheral vessels to identify by palpation or visual inspection~     and past operators would be forced to perform the procedure blind based on anatomical~     landmarks. Recently, to aid vascular identification and increase cannulation success, a~     number of alternative techniques for peripheral vascular access have been described including~     ultrasound-guided.~      Ultrasound-guided vascular access has been utilized in vascular access with improved success~     rate. However, even with ultrasound guidance the first attempt success rate of cannulation~     was only approximately 65%. A proposed failure of ultrasound guided peripheral vascular~     access is most likely due to failure to advance the catheter into the vessel even the vessel~     was successfully punctured. The investigators propose a specific technique and the positive~     Target Sign as a means to obtain almost 100% successful peripheral vascular access.~      The investigators plan to enroll 100 surgical patients in the above study and study~     procedures will not differ from what a patient in the operating room under the care of~     anesthesia faculty would receive. The above study is simply a way to identify the steps~     regarding a specific technique.~   "
121591|NCT01975961|"~     This is a 2 by 2 cross-over study to evaluate pharmacokinetics of telmisartan and~     rosuvastatin FDC compared to reference telmisartan and rosuvastatin coadministered in two~     groups enrolling healthy adult male and female subjects under fasting conditions.~      Subjects will be admitted to the clinic in the evening before Day 1. All subjects will~     receive a single oral dose of telmisartan/rosuvastatin FDC or telmisartan and rosuvastatin~     co-administered in the morning on Day 1. All the subjects will remain in the clinical unit~     until completion of all assessments on Day 2 including collection post-dose PK sample.~     Subjects will return to the clinic for pharmacokinetic samples at scheduled time.~      The two treatment periods will be separated by a washout period.~   "
121592|NCT01975948|"~     The aim of this study is to test the program's effectiveness in a primary care setting in~     reducing stigma among medical personnel, increasing the comfort level of physicians and staff~     in providing care to those living with mental illness, and in improving client well-being and~     mental health.~   "
121593|NCT01975935|"~     This study involves research about an investigational medicine called Amlexanox. The reason~     for this study is to find out how Amlexanox can improve type 2 diabetes, insulin resistance,~     obesity and non-alcoholic fatty liver disease (NAFLD). In this study, Amlexanox is considered~     to be investigational (not approved by the Food and Drug Administration [FDA]) for type 2~     diabetes, insulin resistance, obesity and non-alcoholic fatty liver disease (NAFLD). This is~     a placebo controlled study. There is a 50-50 chance that the patient may either receive the~     study drug, Amlexanox, or a placebo (sugar pill). Neither the patient or the study doctors~     will know if the patient is receiving the study drug or placebo.~   "
121594|NCT01975922|"~     The goal of the study is to examine the effects of teaching parents to use language support~     strategies on language skills in toddlers with language delays. We hypothesize that children~     whose parents who learn to use language support strategies at home will have greater language~     skills than those children whose parents do not learn the strategies.~   "
121595|NCT01975909|"~     Spinocerebellar Ataxia (SCA) refers to a family of genetic diseases that cause progressive~     problems with gait and balance, as well as other debilitating symptoms. This is a randomized~     controlled pilot study to test a novel therapeutic intervention that uses noninvasive~     magnetic brain stimulation to improve functional outcomes in patients with SCA. The study~     will include quantitative evaluations of gait, balance, and brain physiology to examine~     possible objective end-points for a future, larger multi-site clinical trial. The~     investigators anticipate that patients receiving the real intervention will show a functional~     gain.~   "
121596|NCT01975896|"~     This project will compare the preliminary efficacy of a novel school-delivered intervention,~     mindfulness plus health education intervention, to health education alone on dietary and~     physical activity habits in adolescents. This study has important public health implications~     because of the negative consequences of unhealthy diets and lack of exercise on health, such~     as obesity, cardiovascular disease and diabetes. If effective, this intervention has high~     potential for translation to high school settings~   "
121597|NCT01975883|"~     Analyzing peri operative changes in blood glucose levels from non-diabetic patients~     undergoing spine surgery~   "
121598|NCT01975870|"~     The main objective of the project is to make participants aware of their sedentary behavior~     (prolonged sitting behavior) and then to encourage behavioral change through the use of an~     innovative and fun application on a smartphone.~   "
121599|NCT01975857|"~     The broad aim of the proposed study is to evaluate the comprehensive benefit of a novel~     mind-body therapeutic intervention, Mind-Body Bridging (MBB), in Veterans who suffer from~     mTBI and sleep disturbance co-morbid with PTSD and/or pain at the VA Salt Lake City Health~     Care System (VASLCHCS). Evidence for comprehensive benefit includes, but is not limited to,~     the average difference in outcomes between MBB and an active control, sleep education (SED),~     both integrated with the usual care for mTBI Veterans. The long-term goal of the proposed~     project is to introduce, implement and establish mind-body intervention programs as a~     behavioral health intervention modality that would serve as a generally sustainable health~     care intervention program before, during, and after deployment for military personnel.~   "
121600|NCT01975844|"~     Hypothesis: Routine clinical tests with feedback control based Epogen(Epo)/Venofer(Iron)~     protocol will improve Hemoglobin (Hgb) stability and increase the time that patients remain~     in target~      Objectives:~        1. Decreased variability of Hgb~        2. Increase the % of patients in target range c Increase in time that Hgb remains target~          range~   "
121601|NCT01975831|"~     This is a multicenter, open-label, study with a standard 3+3 dose-escalation phase, followed~     by an expansion phase in subjects with solid tumors~   "
121642|NCT01975298|"~     The purpose of the study is to assess the efficacy, safety, and tolerability of two doses of~     laquinimod compared to Avonex®~   "
121604|NCT01975792|"~     The thymus gland is a specialized organ in the chest that plays a central role in the~     adaptive immune system throughout development until puberty. In response to stress, the fetal~     thymus gland may shrink, or involute. The investigators propose a prospective cohort study~     that will enroll pregnant women admitted to labor and delivery for the management of preterm~     labor and/or preterm premature rupture of membranes from 28-36 weeks gestation. Based on~     sonographic thymus measurements, the investigators will develop a clinical prediction tool to~     identify babies who are at increased risk for adverse neonatal outcomes. A reliable~     non-invasive predictor of adverse neonatal outcome using thymic ultrasound measurements has~     the potential to affect clinical management, improve outcomes for premature babies, and~     direct further research efforts.~   "
121605|NCT01975779|"~     To evaluate the safety and tolerability of single- and multiple doses of Lu AE58054 in~     healthy young Japanese men in comparison with Caucasian men.~   "
121606|NCT01975766|"~     This study investigates if using a very low carbohydrate diet during combined chemotherapy~     and radiation therapy is safe and if it can be tolerated by patients.~   "
121607|NCT01975753|"~     Acute pain relief in emergency setting is still a public health priority. Pain is the primary~     reason for emergency room use, but the situation of oligo-analgesia persists in all~     countries. Intravenous morphine titration has become the standard method for severe acute~     pain management in the emergency department, but it is still insufficiently implemented.~     Deviations from the recommended protocol are common: initial additional loading doses,~     unusually extended intervals between bolus, premature discontinuation. Several factors~     contribute to these difficulties: heaviness of its setting up, especially in overcrowding~     case, procedure rigidity, high consumption of nursing time. This method requires a systematic~     intravenously route, which has several inconvenients: algogenic procedures, coupled initial~     diagnostic venous sampling (delay for analgesia), excessive medicalization of ambulatory~     patients (risk of infection and less mobility in the emergency department). An alternative to~     reduce the analgesic latency in emergency department, without losing the benefits of~     tolerance and safety should be welcome. The inhaled route looks promising, but has yet not~     been enough evaluated in adults, and even less in the emergency room. Aerosol techniques~     change from one study to another (molecules, materials, doses, painful intensities included,~     judgment criteria and assessment times). A morphine titration by aerosol therapy could be an~     interesting alternative to the standard method disadvantages, using faster, painless and~     easier procedures, leading to demedicalization.~      To the need for stronger fundamentals, an additional study was designed in healthy~     volunteers. The objective is to compare the titration of intravenous morphine titration~     aerosol in moderate acute pain caused by electrostimulation.~      To purchase this aim, we first need to determine accurately the smallest dose of effective~     and well tolerated inhaled morphine, to provide the bolus dose we have to repeat by~     titration, which is still currently unknown. This dose is called ED50, it's the effective~     dose for at least 50% of healthy volunteers relieved. ED50 for intravenous morphine is also~     needed to be established, unknown in this indication. The determination of these two parallel~     ED50 would allow a reliable conversion factor between the two routes of administration for~     morphine bolus, which can then be tested in comparative titrations. To validate our induced~     pain model in healthy volunteers, we also have chosen to fix in these conditions the ED50 of~     fentanyl that the effective dose by nebulization is better known. This study would also~     describe the pharmacokinetics of inhaled morphine and its derivatives after a single spray.~   "
121608|NCT01975740|"~     Question: Does manual diaphragm release change kinematics and respiratory function of elderly~     subjects? Design: Randomized controlled trial with concealed allocation and double-blinding.~      Participants: 17 volunteers over 60 years old randomized into two groups: 09 in the Control~     Group (CG) and 08 in the Intervention Group (IG).~      Intervention: The manual diaphragm release technique was used on the IG, in two sets of ten~     deep breaths, with a one minute interval between them. The CG underwent a sham protocol~     (light touch), with same sets and time of interval.~      Outcome measures: The groups were evaluated using spirometry, manovacuometry and~     optoelectronic plethysmography (OEP), in that order, before and immediately after the~     intervention.~   "
121609|NCT01975727|"~     Postoperative nausea and vomiting (PONV) are frequent after surgery and anaesthesia.~     Dexamethasone is widely used as antiemetic for the prevention of PONV. Little is known about~     the efficacy of antiemetic drugs for the treatment of established PONV symptoms. No single~     randomised trial has been published so far that tests the efficacy of dexamethasone for the~     treatment of established PONV symptoms. In this trial the investigators want to test the~     antiemetic efficacy of three different doses of intravenous dexamethasone for the treatment~     of established PONV symptoms. In adjunct protocols of this study the investigators aim to~     establish a novel method to quantify the anti-nausea efficacy of an antiemetic drug, to study~     pharmacogenetics of PONV, and to further our understanding on the smoking status as a~     predictive factor of PONV.~   "
121610|NCT01975714|"~     Bimatoprost 0.03% preservative free monodose eye drops solution (BUDPF) is a new product~     composed of a synthetic prostamide, bimatoprost 0.3% in a preservative free formulation. This~     new product is used as a once-daily topical ocular therapy for the reduction of elevated~     intraocular pressure (IOP) in patients with open-angle glaucoma, or ocular hypertension, and~     that are sensitive to preservatives. The individual active component of BUDPF, bimatoprost is~     an established therapeutic agent with well documented IOP efficacy (1). Prostamides, such as~     bimatoprost, are believed to lower IOP mainly by increasing uveoscleral outflow. The~     comparator, Preservative Free Latanoprost 0.005% Unit Dose (LUDPF, eg. Monoprost®), was~     recently launched in a number of countries in Europe and contains latanoprost in a new~     preservative free formulation.~      It is clinically important to compare these newly entered preservative free products with~     respect to tolerability and efficacy. A better tolerability combined with maximum efficacy~     will reduce the burden of daily glaucoma therapy and provide a clear therapeutic benefit to~     the glaucoma patient by providing enhanced compliance and real-world IOP-lowering efficacy.~      The hypothesis of the study is that monodose bimatoprost is more effective than monodose~     latanoprost by at least 1 mmHg.~      (AIBILI applied for an unrestricted grant from Allergan to perform this study)~   "
121611|NCT01975701|"~     This is an open-label non-randomized, multicenter, phase II study of BGJ398 administered to~     adult patients with histologically confirmed GBM and/or other glioma subtypes with~     FGFR1-TACC1, FGFR3-TACC3 fusion and/or activating mutation in FGFR1, 2 or 3.~   "
121612|NCT01975688|"~     To investigate what the body does to single doses of Sativex (i.e. the pharmacokinetics [PKs]~     of four sprays containing 10.8 mg Δ9 tetrahydrocannabinol [THC] and 10 mg cannabidiol [CBD])~     when mild, moderate or severe oral mucositis is induced. This will be done by looking at the~     effects of the body on the drug before and after oral mucositis is induced. The study~     participants will have Non-surgical Head and Neck Squamous Cell Carcinoma (HNSCC), and oral~     mucositis will be induced with radiotherapy and/or chemotherapy.~   "
121613|NCT01975675|"~     This study will evaluate the antiviral efficacy of sofosbuvir (SOF)/ledipasvir (LDV)~     fixed-dose combination (FDC) tablet with or without ribavirin (RBV) in treatment-naive or~     treatment-experienced Japanese participants with chronic genotype 1 HCV infection.~     Participants receive 12 weeks of treatment and continue assessments during a 24-week~     posttreatment follow-up period.~   "
121614|NCT01975662|"~     The aim of this study is to compare the efficacy of daptomycin treatment versus vancomycin~     treatment in the treatment of methicillin resistant staphylococcus aureus (MRSA) bloodstream~     infections (BSI) due to isolates with high vancomycin minimum inhibitory concentrations (MIC)~     (i.e. > or equal to 1.5 ug/ml) in terms of reducing all-cause mortality.~      Our secondary aim is to compare clinical failure rates of daptomycin treatment versus~     vancomycin treatment and to compare time to microbiological clearance in patients treated~     with daptomycin versus those treated with vancomycin.~      Our primary hypothesis is that Daptomycin treatment is superior to vancomycin treatment in~     reducing mortality from BSIs due to MRSA with high vancomycin MIC from 25% to 10%.~   "
121615|NCT01975649|"~     Hypoactive Sexual Desire Disorder ( HSDD ) is very common in postmenopausal women due to a~     reduction in circulating androgen levels. The aim of this study is to evaluate the effects of~     Tribulus Terrestris in premenopausal women with HSDD.~   "
121616|NCT01975636|"~     This is an open-label, single dose study in healthy male subjects.~   "
121617|NCT01975623|"~     VATS anatomical lung resection provides an effective minimally invasive treatment strategy~     for stage I and II lung cancer. VATS lobectomy is associated with significantly less~     postoperative atrial fibrillation, blood transfusion, renal failure, and other complications~     when compared with lobectomy via thoracotomy.~      Although VATS lobectomy has been proven to be effective and safe in experienced hands, it is~     not devoid of risk. Intra-operative surgical complications can be at times catastrophic.~      Currently, in spite of being a safe and effective technique in experienced hands, a minority~     of anatomical pulmonary resections are being performed by VATS. The technical difficulty and~     increased actual and perceived danger of VATS lobectomy is related to PA branch manipulation~     and this is the main limitation for many thoracic surgeons regarding the adoption of VATS~     lobectomy into their practise. Furthermore, the majority of VATS lobectomies are being~     performed in high volume, academic medical centers with a resultant disparity in~     socioeconomic status between those that undergo VATS versus open lobectomy. If we can find a~     way to decrease the manipulation required by the surgeon on the PA branches, these procedures~     will be safer, less stressful for the surgeon and therefore more prevalent for anatomical~     pulmonary resections.~   "
121618|NCT01975610|"~     CC-292 is an oral agent that is under clinical development for the treatment of rheumatoid~     arthritis an autoimmune inflammatory disorder.~      This study will test the clinical effectiveness and safety of an orally (PO) administered~     dose of CC-292 compared to placebo in US female patients currently on background Methotrexate~     (MTX) with active Rheumatoid Arthritis (RA~   "
121619|NCT01975597|"~     This is a feasibility study to demonstrate the team's ability to collect bone marrow~     aspirates and biopsies for research purposes from women with metastatic breast cancer.~   "
121620|NCT01975584|"~     This is a pilot study. We are testing the physiologic, immune and chemical responses to~     stress. We believe the results of all measures to stress will be blunted in schizophrenia~     compared to healthy controls. We will test sex, early life stress and other factors on the~     relationship to a stress response.~   "
121621|NCT01975571|"~     The purpose of this study is to determine if adults and children with residual low-pitch~     hearing in the severe hearing loss range can develop improved speech perception by combining~     their residual acoustic hearing with electrical stimulation through a short cochlear implant.~     The low-pitches would be amplified with a hearing aid and the high-pitch sounds would be~     stimulated electrically.~   "
121622|NCT01975558|"~     Rationale: Local radiotherapy applied in the treatment of tumors changes the metabolic~     profile in the exposed area and/or systemically and specific radiation biomarkers can be~     identified in the respective matrices.~      Purpose: This is a pilot study to verify in humans the results obtained from two animal~     models exposed to ionizing gamma-radiation. The classification of patients results from the~     treatment volume of radiotherapy for cancer disease. Two patient groups with breast cancer~     undergoing high-dose radiotherapy are selected and compared to control group of age matched~     healthy women.~   "
121623|NCT01975545|"~     Patients with trisomy 21 are in greater danger of developing caries. It has been hypothesized~     that adding silver nanoparticles to fluor varnishes could promote remineralization of the~     teeth. A split-plot randomized controlled trial will be performed to address this question.~   "
121624|NCT01975532|"~     The purpose of this study is to explore the relationship between deep brain stimulation~     implantation site and DTI (diffusion tensor imaging) derived measures for the region and~     later compare this to the clinical treatment outcomes.~   "
121625|NCT01975519|"~     The purpose of the phase 1b portion is to evaluate safety and tolerability and determine a~     recommended phase 2 dose for TRC105 when added to standard dose pazopanib in patients with~     advanced soft tissue sarcoma. Up to 18 patients will be treated.~      The purpose of the phase 2 portion is to estimate the PFS of patients with advanced soft~     tissue sarcoma by RECIST 1.1 and estimate ORR in a separate cohort of patients with~     angiosarcoma by RECIST 1.1. Up to 76 patients will be treated in phase 2, including a cohort~     of up to 13 patients with angiosarcoma.~   "
121626|NCT01975506|"~     The purpose of this study is to identify the role of occupational therapy within Head Start~     programs. Representatives within Head Start will be asked to participate in a nationwide~     internet based survey identifying the amount and type of services provided within this area.~     The Model of Human Occupation (MOHO) will also be included in the study by identifying~     current use of the model and how it can be utilized in the future. In order to complete this~     study to the fullest extent, we must begin by defining the Model of Human Occupation as well~     as understanding the mission of the National Head Start Association. The vision of MOHO is to~     support practice that is focused on occupation, client centered, holistic, evidence-based,~     and complementary to other occupational therapy models. The mission of the National Head~     Start Association is to coalesce, inspire and support the Head Start field as a leader in~     early childhood development and education. This has lead researchers to perform the following~     study: An examination of occupational therapy in the context of Head Start.~   "
121643|NCT01975285|"~     The purpose of this research study to evaluate the effects of dexamethasone as an addition to~     peripheral nerve block (Put the nerve to sleep with Bupivacaine a numbing medication) on~     length of pain relief (analgesia), postoperative narcotic (opioids) requirements, pain~     scores, and patient satisfaction after foot and ankle procedures.~   "
121627|NCT01975493|"~     The aim of NAPPA is to develop new models to improve our understanding of how children~     process ('metabolise') penicillins, to help us discover if we can improve the dosing regimens~     used for children in the future. The study population will involve children and neonates who~     need a penicillin antibiotic as part of their normal National Health Service (NHS) care, and~     who also need blood tests or intravenous access. Therefore the antibiotic study can be done~     without the need for any extra invasive procedures, and there will be no change to the~     medication therapy received by participants. In addition, NAPPA will evaluate whether it is~     feasible to measure antibiotic levels on a tiny drop of blood put onto absorbent paper~     (dried blood spot). This allows the sample to be stored and tested later on. NAPPA will~     compare the level of the antibiotic using this method with the level measured in the usual~     way, to show if this is a reliable method that could be used routinely in the future.~   "
121628|NCT01975480|"~     This is an open-label flexible-dose pilot study evaluating the efficacy, safety, and~     tolerability of Pristiq (desvenlafaxine) in outpatient subjects diagnosed with Generalized~     Anxiety Disorder (GAD) with or without comorbidities that are secondary to the GAD. Primary~     trial objective is to evaluate the efficacy of Pristiq (desvenlafaxine) SNRI treatment 50 to~     100 mg once daily in the treatment of GAD with or without comorbidities. Secondary trial~     objective is to determine whether or not treatment outcome in GAD is related to changes in~     cortical prefrontal activity of norepinephrine.~   "
121629|NCT01975467|"~     The objective of this post-market clinical study is to compare one to three year post~     treatment results, range of motion, strength, patient related functional outcomes and patient~     satisfaction, of internal fixation using the Sonoma Orthopedic Products CRx™ as compared to~     nonoperative management (e.g. sling) of similar displaced midshaft clavicle fractures.~   "
121630|NCT01975454|"~     Teng-Long-Bu-Zhong-Tang (TLBZT) is a modern anti-cancer herbal formula. Experimental studies~     have confirmed the anti-cancer potential of TLBZT against colorectal cancer. This trial will~     evaluate the safety and efficacy of TLBZT based herbal therapy in combination with~     chemotherapy in patients with metastatic colorectal cancer.~   "
121631|NCT01975441|"~     This study will determine if a combination of 3 drugs used to treat the infection that cause~     lymphatic filariasis (LF) due to Wuchereria bancrofti infection are more effective in killing~     or sterilizing the adult worms compared to just 2 of the 3 drugs that usually given to treat~     this infection. The three drugs used together are called albendazole (ALB), ivermectin (IVM)~     and diethylcarbamazine (DEC). The usual treatment in Papua New Guinea (PNG) for lymphatic~     filariasis are DEC and ALB. A combination of these 3 drugs has not been previously used to~     treat LF.~   "
121632|NCT01975428|"~     People with chronic diseases such as diabetes, hypertension (high blood pressure) and cardiac~     (heart) arrhythmias tend to go to the doctor more often and have more tests done than those~     without those diseases. This can lead to increasing costs of healthcare and extra visits to~     doctors and healthcare facilities.~      There are now medical devices that can be used at home to monitor blood sugar, blood~     pressure, heart rhythms as well as other measurements. There have been some studies which~     show that when people take their own health readings, they are better able to control their~     disease, stay healthier and go to the doctor less often. In order to participate in the study~     participants will have been diagnosed with 1 or more of the following: Diabetes,~     Hypertension, Cardiac Arrhythmias.~      This study is designed to test those devices and see if they can help participants stay~     healthier through the recording and tracking of health measurements. Investigators will also~     be testing how easy it is to use these devices and whether or how easy it is to fit them in~     their daily schedule. Participants will be given an iPhone for use during the study and their~     recordings will be stored and displayed on the phone.~   "
121633|NCT01975415|"~     This study will investigate the acute response to meditation during a week-long meditation~     retreat at the Chopra Center as measured by the continuous, simultaneous monitoring of~     numerous biometric parameters in selected cohorts of experienced and novice meditators during~     periods of meditation and specific breathing techniques. Comparisons between cohorts as well~     as over time will allow for the identification of meditation and/or breathing-related~     changes.~   "
121634|NCT01975402|"~     We will evaluate the end to end remote monitoring system in a less controlled environment and~     concurrently develop the infrastructure to support the back end of the system~   "
121635|NCT01975389|"~     This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to~     placebo, in reducing the occurrrence of major cardiovascular events, including cardiovascular~     death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization~     in high risk subjects who are receiving background lipid lowering therapy and have~     cholesterol laboratory values of LDL-C >/= 100 mg/dL (2.6 mmol/L) or non-HDL-C >/=130 mg/dL~     (3.4 mmol/L).~   "
121636|NCT01975376|"~     This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to~     placebo, in reducing the occurrence of major cardiovascular events, including cardiovascular~     death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization,~     in high risk subjects who are receiving background lipid lowering therapy and have~     cholesterol laboratory values of LDL-C >/= 70 mg/dL (1.8 mmol/L) or non-HDL-C >/= 100 mg /dL~     (2.6 mmol/L).~   "
121637|NCT01975363|"~     This randomized pilot clinical trial studies a nanoemulsion formulation of curcumin in~     reducing inflammatory changes in breast tissue in obese women at high risk for breast cancer.~     Curcumin may reduce inflammation in breast tissue and fat. This may affect the risk of~     developing breast cancer.~   "
121638|NCT01975350|"~     There might be additional benefit on clinical outcomes from adjunctive colistimethate sodium~     inhalation as therapy for multidrug resistant Gram-negative ventilator-associated pneumonia.~   "
121639|NCT01975337|"~     The primary objective of the study was to compare the single dose pharmacokinetics of~     alisporivir in subjects with end stage renal disease (ESRD) on hemodialysis to those of~     matched healthy subjects. The secondary objective was to evaluate the safety and tolerability~     of a single dose of alisporivir when administered to subjects with ESRD.~   "
121640|NCT01975324|"~     Determine whether dalfampridine (Ampyra) can improve visual function in patients who have had~     nonarteritic ischemic optic neuropathy (NAION) with stable visual impairment.~   "
121644|NCT01975272|"~     The purpose of this study is to determine whether oral or intravenous iron is effective in~     the treatment of anaemia (iron-poor blood) after gynaecologic surgery.~   "
121645|NCT01975259|"~     Most Cystic fibrosis (CF) patients now commonly live well into adulthood, this means they are~     progressively accumulating damage to the insulin-secreting cells inside their pancreas. This~     explains why most adult patients have some degree of abnormal sugar regulation & rates of~     diabetes rise significantly with age. CF related diabetes is categorically different from~     other types of diabetes & its development is serious as it heralds a faster decline in lung~     function & a reduced life expectancy.~      The hallmark of abnormal sugar handling in CF is high glucose levels after meals as the~     damaged pancreas responds abnormally slowly. Over 70% of the initial response of a healthy~     pancreas is induced, not by glucose alone, but by hormones released from the bowel known as~     incretins. We want to establish whether incretins are important in blood sugar handling in CF~     as specific drugs that enhance their effect are now available.~      The study hypothesis is that the incretin system will function normally in patients with~     Cystic Fibrosis. To show this we will measure how much insulin secretion is dependant on~     incretin hormones in CF patients by comparing levels after a sugary drink test and then an~     intravenous glucose drip test (run at a rate that mimics the blood sugar levels obtained~     during the first test to make it a fair comparison ) - as incretins will only be produced in~     the first test when the sugar passes through the bowel any extra insulin produced will be due~     to these hormones. To detect resistance to the incretin hormones we will separately measure~     responses to direct infusions of the hormones themselves. We will explore which components of~     meals cause incretin hormone release from the bowel wall by measuring blood levels after~     different types of meals are consumed. Finally we will measure levels of the enzyme that~     breaks down the incretin hormones (DPP-4) to know if they are deactivated more quickly in~     people with CF. By describing the incretin system in CF we will considerably improve our~     understanding of this important condition as well as potentially highlighting new ways to~     treat it.~   "
121646|NCT01975246|"~     This is a multi-centre, randomised, double-blind, active-controlled, parallel-group~     comparative trial to compare the fixed dose combination (FDC) of telmisartan 80 mg~     +hydrochlorothiazide 12.5 mg and amlodipine 5 mg (T80/A5/H12.5 mg) to telmisartan 80 mg+~     amlodipine 5 mg (T80/A5 mg) in blood pressure lowering effect at week 8, the end of the~     double-blind period in essential hypertensive patients who fail to respond adequately to~     telmisartan 80 mg+ amlodipine 5 mg. Patients are assigned to one of the two groups after a~     6-week open-label run-in period taking T80/A5 mg.~   "
121647|NCT01975233|"~     An observational post-market, open label, multicenter Observatory. The decision to use a WEB~     device to treat the patients has been made before and independently of the decision to~     include the patient in the French Observatory.~   "
121648|NCT01975220|"~     The purpose of this trial is to demonstrate the relative bioavailability of 2 newly developed~     fixed dose combination (FDC) tablets containing empagliflozin & metformin and the single~     tablets of empagliflozin and metformin when administered singularly.~   "
121649|NCT01975207|"~     To determine if treatment of significant depressive symptoms identified in individuals~     attending a family practice improves either psychiatric outcome, overall health care costs,~     or Quality of Life (QOL). Two previously developed treatment approaches - an internet-based~     approach and a comprehensive depression pathway - will be compared to two control groups~     (those who have treatment as usual after screening for depression and measurement of QOL, and~     a second control group who will have QOL data only collected). The investigators hope to help~     Alberta Health Services identify which approach is best as rapidly as possible so that the~     best approach can be implemented throughout the province of Alberta.~   "
121650|NCT01975194|"~     This study will assess the rate at which rosuvastatin will achieve LDL targets in African~     American patients with previous history of stroke or TIA.~   "
121651|NCT01975181|"~     The purpose of this study is to establish a registry that uses observational study methods to~     collect uniform data (clinical, lifestyle and other) to evaluate specific outcomes and to~     enable research on patients at risk for cardiovascular disease (CVD).~      This is a descriptive, observational registry study. All data for participants in the WRNMMC~     Integrative Cardiac Health Project (ICHP) Cardiovascular Health Program (CHP) will be entered~     into a single, secure information management system (IMS) for subjects at risk for CVD. At~     periodical intervals, the IMS will be queried to define the effect of an integrative~     therapeutic lifestyle change (TLC) program on CVD risk over time. This protocol outlines~     collection, storage, and handling of data, describes specific data elements and lays the~     foundation for future research questions.~   "
121652|NCT01975168|"~     A randomized double-blind placebo-controlled crossover trial is conducted. 200 subjects aged~     above 20 years with body mass index (BMI) more than 25 kg/m2 are randomly divided into 2~     groups (Group 1 and Group 2). Group 1 receives laser acupuncture therapy first while Group 2~     receives sham laser acupuncture therapy first. After 12 weeks of treatment and 14 days of~     washout, Group 1 switch to sham laser acupuncture therapy while Group 2 switch to laser~     acupuncture for 12 weeks. The subjects are treated with a gallium aluminum arsenide~     Handylaser Trion, which is used to apply at each of the acupuncture points for 10 seconds~     every time, 3 times per week. The measurements of outcomes are performed in the beginning,~     weekly during treatment, and monthly after treatment for 3 months.~   "
121653|NCT01975155|"~     Celiac disease (CD) is the most common autoimmune enteropathy in Western Countries. Gluten~     free diet is the only available therapy but few is known about its nutrient content and~     mycotoxin exposure.~   "
121654|NCT01975142|"~     Patients with metastatic breast cancer considered HER2 negative are screened for~     HER2-amplified circulating tumor cells. If at least HER2-amplified circulating tumor cell is~     detected, patients are treated by Trastuzumab - Emtansine (T-DM1) in a single arm phase II~     with an adaptive design.~   "
121655|NCT01975129|"~     This study aims to evaluate the uptake of oxytocin following intravaginal administration of~     Vagitocin 400IU over a period of 15 days and also to compare oxytocin bioavailability after~     vaginal and intravenous administration. 12 healthy postmenopausal female volunteers, 40 to 70~     years old with vaginal atrophy will be included and will self-administer Vagitocin~     intravaginally on day 2-14 (day 1 and 15 Vagitocin is given in the clinic). On day 22 a~     single intravenous dose of oxytocin 10 IU Syntocinon® will be given. Oxytocin plasma levels~     after intravaginal and intravenous administration will be analysed day 1, 15 and 22 at~     timepoints: -1.0, -0.5, 0, 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 6.0 and 8.0 hours,~     relative to dosing. Based on the obtained plasma levels for oxytocin, pharmakokinetic~     variables will be calculated. The % of oxytocin which was absorbed following vaginal~     administration (bioavailability)will also be calculated.~   "
121656|NCT01975116|"~     This phase I trial studies the side effects and best dose of azurin-derived cell-penetrating~     peptide p28 (p28) in treating patients with recurrent or progressive central nervous system~     tumors. Drugs used in chemotherapy, such as azurin-derived cell-penetrating peptide p28, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing.~   "
121659|NCT01975077|"~     Fruquintinib is a novel oral small molecule compound discovered and developed by Hutchison~     MediPharma that selectively inhibits vascular endothelial growth factor receptors (VEGFR) 1,~     2, and 3 and has demonstrated potent inhibitory effects on multiple human tumor~     xenografts.Based on first-in-human study, both 4mg QD and 5mg 3wks on/1wk off are safety and~     efficacy, this phase Ib study is to evaluable the safety, tolerability and efficacy of these~     2 regimens with mCRC failed 2nd therapy or more and to determine the recommended dose and~     regimen in phase II/III study.~   "
121660|NCT01975064|"~     The purpose of this study is to determine whether anesthesia maintained with propofol results~     in better one- and five-year-survival than anesthesia maintained with sevoflurane.~   "
121661|NCT01975051|"~     We hypothesize that PKDL develop after SSG as well as after Miltefosine mono-therapy for VL;~     anti-inflammatory cytokines such as IL-10, TGF-β, serum lipids play key role for its~     pathogenesis & PKDL patients are genetically predisposed; diagnostic tool based on~     immunofluorescence technique will be more sensitive than slit skin examination for diagnosis~     of PKDL.~   "
121662|NCT01975038|"~     Determining Fitzpatrick skin phototypes (FST) allows physicians to assess a person's risk of~     developing sunburn, and thus the need for sun protection to prevent the development of skin~     cancer. Reflectance spectrophotometry objectively measures the melanin index (MI) and can~     assist in determining the accuracy of self-reported FST compared with~     dermatologist-determined FST. At present, we seek to determine the accuracy of an adapted~     Skin Sun Sensitivity Scale for individuals of all pigmentation varieties (FST I through VI)~     as compared with spectrophotometric measurements assessing FST. Our principal objective is to~     correlate the MI under usual conditions by spectrophotometry with the adapted Fitzpatrick SPT~     as determined by the patients' responses to the adapted questionnaire.~   "
121663|NCT01975025|"~     The aim of this clinical research project is to test the hypothesis that daily dialysis has~     favorable effects on the calcification propensity of human serum, when determined by the~     investigators' newly developed in vitro serum test. The investigators' hypothesis is that~     shorter interdialytic intervals will result in an improved calcification propensity of serum.~     The determination of serum calcification has the potential to become a novel measure of~     dialysis quality in the future.~   "
121664|NCT01975012|"~     Development of tolerable and effective antiretroviral (ARV) drugs for use in children and~     adolescents remains a high priority. First-line therapy with non-nucleoside reverse~     transcriptase inhibitors (NNRTIs) has proven to be effective for HIV-1-infected infants,~     children, and adolescents. This study will evaluate the safety, effectiveness, and dosing~     levels of the NNRTI rilpivirine (RPV) when given with two other ARV drugs in treatment-naive,~     HIV-1-infected children less than 12 years of age.~   "
121665|NCT01974999|"~     This study is a multicenter, non-randomized, retrospective study to collect long term (5~     years post-transplant) clinical outcome data to test whether the results of the noninvasive~     immune monitoring test strategy performed in the parent study (CTOT-01, NCT00308802) in first~     six-month post-transplant is predictive of 5-year outcomes. Each center will complete a~     retrospective chart review for the data on patient survival, graft survival and renal~     function.~   "
121666|NCT01974986|"~     Athletes participating in multiple training sessions a day can be at increased risk of~     suboptimal hydration and heat illness during their second training session, especially when~     the environment is hot and humid. With the exception of the absolute volume of water~     delivered by a rehydration beverage, characteristics of the beverage consumed play a role in~     the recovery and completeness of rehydration. The amount of sodium in the beverage has been~     shown to be a primary factor in rehydration. Recently, an effect of the carbohydrate~     concentration of the beverage was been reported, with its effects mediated by the renal~     system in response to elevated serum insulin. The purpose of this study is to compare sodium~     and carbohydrate effects on rehydration and recovery.~   "
121667|NCT01974973|"~     The purpose of this study was to study the effect of stem cell therapy on common symptoms in~     patients with autism spectrum disorders~   "
121668|NCT01974947|"~     Multidisciplinary, multicentric, cross-sectional study on men in infertile couples who~     conduct their sperm test through their diagnosis of infertility~   "
121669|NCT01974934|"~     To examine the efficacy and safety of treatment with desvenlafaxine for vascular depression.~     Primary efficacy, as it pertains to depressive symptoms, will be assessed by overall change~     in symptom severity score from baseline to 12-weeks, measured by the Geriatric Depression~     Scale. The primary efficacy measure of cognition will be the Montreal Cognitive Assessment~     and analysis of change between baseline and 12-week scores.~      To evaluate the effectiveness of desvenlafaxine as a first-line treatment for vascular~     depression in a sub-group of patients who have experienced a TIA greater than 6 weeks prior~     to baseline. Mean differences between baseline and 12-week efficacy measures will be examined~     within the sub-group.~   "
121670|NCT01974921|"~     The purpose of this study is to evaluate clinical and histological response to bronchial~     thermoplasty in severe asthma patients.~   "
121671|NCT01974908|"~     This study involves recording electrical signals inside the heart during an ablation~     procedure. It is thought that by studying these electrical signals in detail the~     investigators may be able to better identify and treat patients at risk of Ventricular~     Tachycardia (VT).~      VT is where the lower chambers (ventricles) of your heart beat fast and this condition can be~     life-threatening. An ablation procedure is performed in patients who have VT despite the best~     treatment available with tablets.~      Cardiac ablation involves interrupting the abnormal electrical signals, which cause VT, by~     applying a type of electrical energy through a catheter. An important part of the ablation~     procedure is the identification of the exact part of the heart muscle responsible for causing~     the VT. This typically involves sampling the electrical signals in lots of different areas of~     the heart, which allows the construction of computer generated 3 dimensional pictures of the~     structure and the electrical circuits inside the ventricle. Recent research has identified a~     new method to interpret these electrical signals (called Fibrillatory Factor - FF), which may~     allow better identification of the area within the ventricle that should be ablated.~      A standard VT ablation will often involve us controlling the heart-beat by pacing the heart~     through 1 of the investigators catheters within the heart. The electrical response to pacing~     at different heart rates can often provide your doctor with information to help the ablation.~     This study will involve an additional period of pacing at different heart rates, during which~     the electrical response is measured in different areas around the ventricle. This will allow~     us to calculate areas of the ventricle, which the investigators new measure FF would predict~     to be the source of the VT. In the future this may then allow us to better identify patients~     who are at risk of VT, and to better locate the area that needs to be ablated.~   "
121672|NCT01974895|"~     The purpose of this study is to evaluate the immunogenicity and safety of the new influenza~     vaccine GSK2282512A (FLU Q-QIV) and compare its activity to Sanofi Pasteur's Fluzone® (TIV)~     in children 6 to 35 months of age.~   "
142504|NCT01702038|"~     The purpose of this study is to determine how B cell subsets and autoantibodies are related~     to disease remission after rituximab treatment in subjects with Systemic Lupus Erythematosus~     (SLE).~   "
121673|NCT01974882|"~     Postoperative pain is an unavoidable consequence of open abdominal surgery. Although~     cryotherapy, the application of ice to a surgical wound site, has been shown to be effective~     in reducing postoperative pain in orthopedic, gynecologic, and hernia operations, it has not~     been assessed in patients who undergo major open abdominal operations. We hypothesized that~     patients who receive cryotherapy would report lower pain scores as a primary outcome measure.~     This would result in less narcotic analgesia usage, and shorter hospital stays as secondary~     outcome measures.~   "
121674|NCT01974869|"~     Background: The immunologic response to stress is regulated by the cytokines. Anti-Tumor~     Necrosis Factor-α agents are antibodies directed against a key cytokine in the process~     angiogenesis and collagen synthesis. It is not known whether they intervene with surgical~     stress response increasing the rate of postoperative complications.~      Method: Un-blinded prospective, non-interventional cohort single centre study including all~     the patients with Crohn's disease and Ulcerative Colitis undergoing abdominal surgery.~     Immunological and endocrinological parameters will measured in blood samples taken from these~     patients before and after surgery. Power calculations showed that 17 patients in each arm are~     needed.~   "
121675|NCT01974856|"~     The primary objective of this study is to assess the extent to which the Prosigna™ Breast~     Cancer Prognostic Gene Signature Assay affects the medical oncologist's treatment~     recommendations regarding adjuvant chemotherapy and actual treatments received for patients~     with early-stage breast cancer.~   "
121676|NCT01974843|"~     Caudal block is the regional anesthetic technique that is used most frequently in pediatric~     surgery. Opioid drugs have been added to local anesthetic solutions to prolong duration of~     analgesia but ideal combination were not found that has minimal adverse effect. The aim of~     this study was to compare the postoperative analgesic efficacy of equal concentrations of~     bupivacaine plus tramadol or levobupivacaine plus tramadol in pediatric patients undergoing~     minor urological surgery.~   "
121677|NCT01974830|"~     This is a longitudinal, observational, non-interventional registry study, designed to collect~     both retrospective and prospective real world data, on patients receiving Alpha-1~     augmentation therapy in the home through Coram Specialty Infusion.The data will be collected~     from standard Coram homecare forms, as well as patient reported case forms.~   "
121678|NCT01974817|"~     The purpose of the study is to determine the response of 13-valent conjugate pneumococcal~     vaccine in patients 50 years or older with end stage renal disease on dialysis.~      The study will also try to determine Streptococcus pneumoniae colonization in patients 50~     years or older with end stage renal disease on dialysis.~   "
121679|NCT01974804|"~     Magnetic resonance imaging (MRI) is a diagnostic study that makes pictures of organs of the~     body using magnetic field and radio frequency pulses that can not be felt. The purpose of~     this study is to determine if new imaging methods can help tumor evaluation in the brain. The~     extra images will be obtained using diffusion and perfusion MRI techniques to assess early~     treatment response in patients with brain metastasis, and will be compared to methods~     currently being used.~   "
121680|NCT01974791|"~     The broad aim of the study is to implement and evaluate the efficacy of Graded Exposure~     Treatment (GET Living) to target elevated pain-related fears in children with chronic pain.~     Pain-related fear is an important psychological factor associated with poor outcomes in~     children suffering with chronic pain. To examine the efficacy of GET Living in addressing~     pain-related fears the investigators propose to use a sequential replicated randomized~     single-case experimental phase design with multiple measures. The specific aims are to 1)~     evaluate the effectiveness and acceptability of individually tailored GET Living for children~     with high pain-related fear and functional disability and 2) define anatomical and resting~     state connectivity patterns in the brains of children and adolescents with complex chronic~     pain prior to and after participation in GET Living.~   "
121681|NCT01974778|"~     Brown adipose (fat) tissue (BAT) is a type of fat tissue found in certain small rodents and~     human babies that is capable of extremely high rates of energy burning. We now know that in~     adult humans it is present and also able to burn energy.~      In addition to increased energy expenditure during cold exposure, energy burning is also~     increased after consuming a meal. Animal studies have shown that part of this additional~     energy consumption is contributed by BAT. In the present study we will aim to examine whether~     BAT activity is increased after a meal.~   "
121682|NCT01974765|"~     This is a Phase II study. The purpose of this study is to find out what effects, good and/or~     bad enzalutamide has on the patient and the cancer. All patients who enter the study will be~     closely monitored for side-effects. If multiple patients develop significant side effects~     from enzalutamide, the study may be stopped early.~      Enzalutamide is an androgen-receptor inhibitor, which means that it blocks the activity of~     the hormone testosterone. In ovarian, fallopian tube, and primary peritoneal cancers that~     express the androgen receptor, blocking the androgen-receptor may possibly slow or stop tumor~     growth. Enzalutamide has been studied in women with breast cancer, but this is the first~     study using enzalutamide for the treatment of patients with ovarian, primary peritoneal, or~     fallopian tube cancer.~   "
121683|NCT01974752|"~     Selumetinib therapy in patients with metastatic uveal melanoma.~   "
121684|NCT01974739|"~     Acquired hypernatremia appears to be associated with mortallity in ICU. To reduce~     hypernatremia and shorten the time of hypernatremia, we investigate the effect of~     hydrochloorthiazide compared to a placebo~   "
121698|NCT01974557|"~     Primary: To observe how hemodynamic parameters are affected by age during rest and exercise~     in healthy humans. Furthermore, how an acute fluid challenge changes hemodynamic parameters.~      Secondary: To thoroughly examine this population with regard to cardiac performance and~     function, anthropometrics, metabolic status, exercise capability, constitution, pulmonary~     status, and humoral markers of organ functions. This population will serve as a healthy~     control group, to which different populations can be compared, hence the need for a~     comprehensive characterization.~      Hypotheses:~      Diastolic function and parameters associated with diastolic function gradually deteriorate~     with increasing age. The gradual deterioration is unmasked at an earlier age during exercise~     and fluid challenge, compared to measurements made at rest.~   "
122720|NCT01961180|"~     Objectives: To investigate the effect of Cipralex versus placebo on stress hormones, glucose~     metabolism, physical and mental health and quality of life in polycystic ovary~     syndrome(PCOS).~      Treatment: 2x20 women for 12 weeks. Design: Double blinded, randomized, placebo controlled.~   "
121685|NCT01974726|"~     The aim of this study is to determine which of the many Eustachian tube function tests (or~     combination of tests) is most helpful in finding out what is causing ear problems in children~     and adult patients with middle-ear diseases thought to be due to poor Eustachian tube~     function. The Eustachian tube is a biological tube that connects the middle ear to the back~     of the nose and throat. When the Eustachian tube works normally, it opens and closes to help~     keep the pressure in the middle ear the same as room air-pressure (atmospheric pressure).~     When the Eustachian tube does not work well, the pressure in the middle ear can increase or~     decrease and feel like a blocked ear or cause ear pain. Poor Eustachian tube function can be~     associated with distressing middle-ear symptoms, predispose to middle-ear problems under~     conditions of rapidly changing air pressures such as occur during airflight and diving, and~     cause certain middle-ear diseases such as otitis media with effusion. It is also known that~     the results for the most commonly used Eustachian tube function tests in adults and children~     with various middle-ear diseases are poorer when compared to children and adults without~     middle-ear diseases. However, knowing that there is a difference in test results between~     groups with and without disease does not mean that any of those tests provide information~     useful in the management of individual patients with diseases due to Eustachian tube~     function. To be useful clinically, a test(s) that can accurately identify patients with a~     level of poor Eustachian tube function sufficient to cause middle-ear symptoms and signs~     and/or cause middle-ear disease is needed. To be very useful, tests should be able to~     diagnose the cause of any observed Eustachian tube problem so that treatment for that problem~     could be begun. The investigators would also want tests that could predict whether or not the~     ear disease will resolve with (or without) treatment and whether or not certain surgical~     procedures for middle-ear problems will be successful. Here, a number of Eustachian tube~     function tests are being used to diagnose and characterize the cause of Eustachian tube~     dysfunction in children and adults presenting to the research clinic with suspected poor~     Eustachian tube function and/or a recent history of middle-ear disease that can be caused by~     poor Eustachian tube function. After the testing, medical records will be periodically~     reviewed for 2 years and study participants will be contacted by phone to obtain information~     on their middle-ear disease, the response of the disease to any treatments and the~     success/failure of any surgical procedures used to fix middle-ear problems.~      Because this study focuses on evaluating the potential usefulness of Eustachian tube function~     testing for the diagnosis of Eustachian tube dysfunction and, if present, its cause, no~     specific treatments or surgical interventions are included in this study or recommended by~     the investigators. These decisions are left to the subject-patient in consultation with their~     doctor.~      To further evaluate the Eustachian function tests, a control group of healthy adults without~     a history of middle-ear problems will undergo testing at two separate sessions; these~     subjects will have no further follow-up.~   "
121686|NCT01974713|"~     Longitudinal cohort of patients with chronic kidney disease followed in 3 kidney centers in~     Ontario. The goal is to determine whether and how rates of renal disease progression are~     affected by inflammatory markers, FGF23 levels, and genetic polymorphisms~   "
121687|NCT01974700|"~     Seizures are a potential complication of surgical repair of intracranial aneurysms. In order~     to prevent seizures, many surgeons administer prophylactic anti-epileptic medication during~     the intra-operative and post-operative period, however, such practice is not supported by~     clinical data. Retrospective review found the incidence of postoperative seizures was higher~     in those who received anti-epileptics versus those who did not. The goal is to examine the~     utility of levetiracetam (Keppra) for seizure prophylaxis in patients undergoing surgical~     repair of unruptured intracranial aneurysms.~   "
121688|NCT01974687|"~     This is a multi-part study to evaluate the safety, tolerability, and pharmacokinetics (PK) of~     uprifosbuvir (MK-3682/IDX21437) in healthy participants and in participants infected with HCV~     genotype (GT)1-GT6. The effect of food on the PK of uprifosbuvir will be evaluated. The~     antiviral activity of uprifosbuvir will also be assessed in HCV-infected participants.~   "
121689|NCT01974674|"~     It is a multicentre, sequential, phase II clinical trial, aiming at evaluating the allogeneic~     islet transplantation for the treatment of type 1 diabetes.~      19 patients with type 1 diabetes will be included and ideally distributed evenly: patients~     with unstable diabetes without renal insufficiency (AI group for islet alone by the~     international customary determination) and patients with a functioning kidney transplant (IAK~     group for islet after kidney). The main endpoint will be defined by the restoration of~     normal glycemic control without insulin at 6 months after graft.~   "
121690|NCT01974661|"~     The primary objective of this study is to answer the question Is it possible to inject the~     COMBIG-DC vaccine in a hepatic tumor without getting unacceptable side effects?~   "
121691|NCT01974648|"~     The aims of this study were to determine the clinically required concentration of propofol~     for LMA Supreme insertion, and to examine to what extent remifentanil reduces the dose of~     propofol and improves conditions for it's insertion.~   "
121692|NCT01974635|"~     In this study, an FDA-cleared device and type of treatment called AMES, which stands for~     Assisted Movement with Enhanced Sensation, will be used to determine whether sensation in the~     upper limb of individuals with incomplete spinal cord injuries, acquired brain injury, or~     stroke improves along with movement through treatment. We hypothesize that measureable~     improvement in the sensation of the upper limb will precede improvement in functional~     movement.~   "
121693|NCT01974622|"~     The purpose of this research is to use an approved drug(Visudyne) for neovascular age-related~     macular degeneration, which is essentially choroidal neovascularization for permeability and~     vascular proliferation for the retinal circulation, to treat another permeable abnormality -~     retinal capillary abnormalities - located eccentric to the central portion of the macula or~     in the foveal region.~   "
121694|NCT01974609|"~     The purposes of this noninferiority randomized clinical trial are to:~        1. determine whether the most commonly used commonly used non-narcotic analgesic (ibuprofen~          600 mg + acetaminophen 325 mg) provides pain relief that is not unacceptably worse than~          the most commonly prescribed narcotic containing analgesic (hydrocodone 5 mg. +~          acetaminophen 325 mg, equivalent to Norco 5/325) in patients undergoing carpal tunnel~          release.~        2. Determine whether the following covariates affect pain level following surgery or~          medication usage: gender, country (US/Canada), pre-operative CTS symptoms, site, workers~          compensation status and employment status (employed/self-employed/unemployed-able to~          work/unemployed-unable to work)~   "
121695|NCT01974596|"~     The aim of this study was evaluate the effects of the oral probiotic Lactobacillus reuteri~     Prodentis upon the peri-implant health of edentulous patients with dental implants and~     peri-implant mucositis, establishing comparisons versus implants without peri-implant~     disease. The hypothesis of the study is that using these probiotics are going to improve the~     periimplant health.~   "
121696|NCT01974583|"~     Split-thickness skin grafting remains fundamental treatment of patients with deep burns and~     other traumatic injuries. However, the split-thickness skin graft (STSG) donor site dressing~     has been controversial until now. Our study here aimed to assess patient comfort and~     wound-healing efficacy with the application of thin split-thickness grafting on STSG donor~     sites.~   "
121697|NCT01974570|"~     Hypertension is an important risk factor of cardiovascular (CVD) and renal diseases.~     Epidemiological studies show that there is a direct relationship between blood pressure and~     CVD, and cardiovascular mortality increases progressively throughout the range of blood~     pressure, including the prehypertensive range. There is also evidence from cell and animal~     studies that shrimp tissue hydrolysates may have higher ACE inhibitory activity than other~     marine protein hydrolysates. It is hypothesized that Marealis RPC (refined peptide~     concentrate)will lower systolic blood pressure in subjects with elevated blood pressure.~   "
121699|NCT01974544|"~     The obesity and type 2 diabetes mellitus (T2DM) are among the most threatening health crisis~     for the 21st century. Currently, it is estimated that there are 205 million people with T2DM~     worldwide. Chile has a similar magnitude of problem with the prevalence of diabetes~     increasing from 6.3% in 2003 to 9.4% in 2010. T2DM is a complex disease characterized by~     hyperglycemia, insulin resistance and a relative β-cell failure. Well-known studies for the~     treatment of T2DM (ADVANCE trial) showed that intensive medical treatment significantly~     reduces the complication of diabetes. On the other hand, less than 40% of patients with T2DM~     achieve a metabolic control of diabetes, despite medical treatment. Recently, bariatric~     surgery has emerged as an effective treatment for T2DM. Data from different sources has shown~     that Roux-en-Y Gastric Bypass (RYGB) can place T2DM into remission. More recently, Sleeve~     Gastrectomy (SG) has been shown to also impact metabolically and hence also emerged as an~     attractive T2DM-controlling bariatric procedure with fewer complications than RYGB. Recently,~     the International Federation for Diabetes has supported the use gastrointestinal surgery~     initially developed for morbid obesity as an option to treat patients with diabetes. In the~     current proposal the investigators aim to address several issues concerning metabolic surgery~     and the ability of the most common bariatric procedures performed to control diabetes. The~     investigators are proposing a prospective randomized trial comparing RYGB, SG and the best~     medical treatment availed for the T2DM in poorly control patients with the primary endpoint~     being 36 month glycemic control (patients achieving HbA1C < 6.5%, normal glucose levels not~     requiring medication). The main working hypothesis is that RYGB and SG achieves better~     glycemic control than the best treatment availed for the T2DM based on more effective~     mechanisms to enhance insulin secretion, insulin sensitivity, lipid metabolism and blood~     pressure control. The goals are, 1) Is gastric bypass surgery and sleeve gastrectomy safe for~     the microvascular complications of T2DM?; 2) Can gastric bypass, sleeve gastrectomy surgery~     and intensive non surgical treatment reverse or reduce the progression of microvascular~     complications of T2DM?; and 3) Can gastric bypass and sleeve gastrectomy realize a return on~     investment within 2 years in patients with type 2 diabetes who are at risk of developing or~     deteriorating microvascular complications?~   "
121700|NCT01974531|"~     The purpose of the present prospective study is the analysis of risk and protective factors~     of perinatal stress and psychological distress of parents with or without a preterm child.~     Stress is measured biologically by Cortisol levels and psychologically by a questionnaire.~     Different outcomes of psychological distress (e.g. anxiety, depression, posttraumatic stress~     disorder, burnout) are measured by various questionnaires. We analyze the influence of~     different aspects as personality traits, social support, partnership.~   "
121701|NCT01974518|"~     The purpose of this study is to compare the effectiveness of rituximab alone vs combination~     of rituximab and cyclophosphamide in the treatment of pemphigus not responding adequately to~     routine medications.~   "
121702|NCT01974505|"~     Optiscope (Clarus Medical, Minneapolis, MN, USA) is a semi-rigid fiberscope for endotracheal~     intubation. This study will investigate learning curve of Optiscope by anesthesia providers.~   "
121703|NCT01974492|"~     In coronary artery bypass grafting, saphenous veins are widely used as a composite grafts~     that are Y-anastomosed to in-situ left internal thoracic artery. Based on our observation~     that remodeling of saphenous vein graft differs between those harvested from upper leg vein~     and lower leg, this study aims to compare histologic and immunohistochemical findings between~     saphenous vein grafts harvested from upper leg and lower leg.~   "
121704|NCT01974479|"~     Modern therapy for patients with B-lineage acute lymphoblastic leukemia (ALL) is based on~     intensive administration of multiple drugs. In patients with relapsed disease, treatment~     response is generally poor; for most patients, particularly those who relapse while still~     receiving frontline therapy, the only therapeutic option is hematopoietic stem cell~     transplantation (HSCT). There is no proven curative therapy for patients who relapse after~     transplant.~      Natural killer (NK) cells have powerful anti-leukemia activity. In patients undergoing~     allogeneic HSCT, several studies have demonstrated NK-mediated anti-leukemic activity. NK~     cell infusions in patients with leukemia have been shown to be well tolerated and void of~     graft-versus-host disease (GVHD) effects.~      NK cell cytotoxicity is most powerful against acute myeloid leukemia (AML) cells, whereas~     their capacity to lyse ALL cells is generally low. We have developed a novel method to expand~     and redirect NK cells towards CD19, a molecule highly expressed on the surface of B-lineage~     ALL cells but not expressed on normal cells other than B-lymphocytes. In this method, donor~     NK cells are first expanded by co-culture with the cell line K562-mb15-41BBL and interleukin~     (IL)-2. Then, the expanded NK cells are transduced with a signaling receptor that binds to~     CD19 (anti-CD19-BB-zeta). NK cells expressing these receptors showed powerful anti-leukemic~     activity against CD19+ ALL cells in vitro and in an animal model of leukemia.~      This study will assess the feasibility, safety and efficacy of infusing expanded, activated~     redirected NK cells into research participants with B-lineage ALL who have persistent disease~     after intensive chemotherapy . In this same cohort, we will study the in vivo lifespan and~     phenotype of these redirected NK cells.~   "
121705|NCT01974466|"~     To compare different goals of fluid resuscitation in early stage of acute pancreatitis~   "
121706|NCT01974453|"~     Radiation issue during percutaneous coronary interventions is an important issue for~     operators due to the long term stochastic risk of cancer induction, but is often~     under-evaluated. Many factors may be associated with the radiation dose adsorbed by~     operators. In particular the most important are the position taken by the operator, the use~     of dedicated X-ray shield and the duration of the procedure. However other factors (as~     operator height or the angulation of the radiation tube) might have some important effects~     but are often under-evaluated .~      Aim of our observational study is to evaluate the most important determinants of the~     radiation dose adsorbed by operators during different coronary procedures (diagnostic~     coronary angiography or percutaneous coronary interventions) and through different vascular~     accesses (right or left transradial approach or transfemoral approach).~      All patients who underwent to percutaneous coronary diagnostic or interventional procedures~     will be enrolled in this observational study.~      Each operator will be equipped with dedicated dosimeters placed at left wrist, at thorax~     level outside the lead apron and at head level to evaluate the radiation dose at crystalline.~     Effective doses delivered to patients will be expressed as dose area product (DAP) and~     measured in Gycm2.~   "
121707|NCT01974440|"~     The purpose of this study is to evaluate the efficacy and safety of PCI-32765 (ibrutinib)~     administered in combination with either bendamustine and rituximab (BR) or rituximab,~     cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in adult participants~     with previously treated indolent Non-Hodgkin lymphoma.~   "
121708|NCT01974427|"~     Objective:~      The goal of this protocol is to improve understanding scale-free brain activity and conscious~     vs. unconscious processing by performing small behavioral, electrophysiological, neuroimaging~     and brain stimulation pilot substudies. This research is expected to help develop techniques~     and hypotheses for future research on these topics.~      We will conduct:~        -  Pilot Substudy: Pilot substudies are exploratory in nature, in order to develop enough~          information to generate a hypothesis. The criterion for transition to a new full~          protocol will be acquisition of sufficient information to generate a power analysis.~          There are no enrollment limitations for pilot substudies.~        -  Hypothesis-Testing Substudy is defined as a study with a specific hypothesis to be~          tested that can be completed with a few healthy volunteers or patients.~          Hypothesis-testing substudies will undergo statistical and PIRC reviews after 6 subjects~          (if there is one group) or after 12 (6 per arm) if two groups are studied before~          additional subjects are recruited. In the event of subject dropout or unsuccessful~          recording, replacement will be recruited. Together, the P.I. and PIRC will decide~          whether to continue the hypothesis substudy with more subjects without an amendment or~          whether an amendment or new protocol would be necessary. A memo requesting a review of~          hypothesis-testing substudies for possible additional enrollment will be sent to PIRC~          and the statistical reviewer. The memo will be forwarded to the CNS IRB.~        -  Technical development of new experimental paradigms and data analysis methods.~      This protocol includes only non-invasive techniques with minimal risk (MRI, EEG, MEG, EMG,~     tDCS).~      Study Population:~      We plan to recruit up to 120 healthy volunteers aged 18-65.~      Design:~      We will design small projects that are pertinent to the theme of scale-free brain activity~     and conscious/unconscious processing. We will investigate healthy volunteers in the resting~     state or while they perform simple motor or sensory tasks. If a hypothesis testing substudy~     leads to results of interest and if a larger population is necessary to reach statistical~     significance, a separate protocol will be submitted with a priori hypotheses, specific study~     design and power analysis adapted from the pilot or exploratory substudies performed in the~     present protocol.~      In the substudies, brain activity of healthy human volunteers will be monitored by functional~     magnetic resonance imaging (fMRI), magnetoencephalography (MEG), electroencephalography~     (EEG), or simultaneous MEG-EEG. Anatomical MRI will be collected in some subjects to allow~     better localization of brain dynamics. Because transcranial direct-current stimulation (tDCS)~     is ideally suited to modulate the slow component of scale-free brain activity, we will also~     investigate the effect of tDCS on brain activity and/or behavioral performance in cognitive~     tasks. tDCS will be administered sequentially, but not simultaneously, with brain-activity~     monitoring by fMRI/MEG/EEG. Most experiments will be conducted in conjunction with cognitive~     tasks. In some experiments, we will study resting-state brain function, during which~     spontaneous brain activity is collected without a specific externally administered task.~      Outcome Measures:~      MRI: to analyze measures such as the anatomical structures of the brain (using structural~     MRI); amplitude of the blood-oxygenation-level-dependent (BOLD) signal (using fMRI); cerebral~     blood flow [using arterial spin labeling (ASL)] and different neurotransmitter levels in~     brain regions of interest [using magnetic resonance spectroscopy (MRS)].~      EEG and MEG: to quantify measures such as power spectrum, event- or task-related potentials,~     synchronization/desynchronization, and coherence between sensors or sources located close to~     the brain areas of interest.~      tDCS: to analyze changes in behavioral measures and/or fMRI/EEG/MEG activity caused by tDCS.~      Behavioral measures: to quantify measures such as hit rate, reaction times, electromyography~     (EMG) patterns.~      We may measure autonomic data during the course of the experiment (such as heart rate,~     respiration, end-tidal CO2, skin conductance), which will be correlated with the outcome~     measures.~   "
121709|NCT01974414|"~     The study aimed to evaluate the effect of cedar honey in treatment of erosive and atrophic~     oral lichen planus ( a common oral problem).~   "
121710|NCT01974401|"~     in this study , effectiveness of supragingival irrigators containing chlorhexidine is~     compared with routine oral health measures in patients with blood dyscrasia whom can not use~     effective oral health measures(e.g brushing ) due to their systemic condition(e,g,neutropenia~     ,thrombocytopenia,..)~   "
121711|NCT01974388|"~     Laparoscopic sleeve gastrectomy (LSG) is a surgical technique that treats morbid obesity by~     both restrictive and hormonal action.~      Consecutive patients with morbid obesity treated by LSG at our department were evaluated.~     Patients enrolled in the study were randomized into Group I: LSG begin the division 2 cm from~     the pylorus and Group II: LSG begin the division 6 cm from the pylorus. The primary outcome~     measure was the % of excess weight loss (%EWL); secondary outcomes included operative time,~     day to resume oral feeding, postoperative morbidity and mortality, improvement of~     comorbidity.~   "
121712|NCT01974375|"~     The purpose of this study is to demonstrate non-inferiority of micafungin at a dose of 100~     mg/day versus fluconzeole for the prevention of Invasive Fungal Disease, defined according to~     the revised EORTC/MSG criteria, undergoing living-donor liver transplantation.~   "
121713|NCT01974362|"~     In patients that did a full mouth implant supported rehabilitation does Cad/Cam Monolithic~     Zirconia, compared to Cad/Cam Zirconia Suprastructure (zirconium oxide (Yttrium - partially~     stabilized with tetragonal polycrystalline structure) veneered with feldspathic ceramic, has~     less post-insertion complications after 1-Year follow-up ?~   "
121714|NCT01974349|"~     Study to assess the effect of food on the Pharmacokinetics of Selumetinib (AZD6244;~     ARRY-142886) (Hyd-Sulfate) in Healthy Male Volunteers~   "
121715|NCT01974336|"~     The efficacy of UDCA in treating the parenteral nutrition-associated cholestasis(PNAC) has~     been identified by some studies in children without short bowel syndrome(SBS).Most of the~     adults who suffering PNAC have SBS. it limits the potential function of UDCA because of the~     lack of SBS patients and malabsorption of UDCA.Therefore, we design this clinical trial in~     our center of SBS to approach the preventative and therapeutical effect of UDCA to PNAC in~     adults with short bowel syndrome.~   "
121716|NCT01974323|"~     This study will assess the safety and efficacy of dapsone gel versus vehicle control in~     patients with acne vulgaris.~   "
121717|NCT01974310|"~     Idiopathic macular holes are an important cause of visual loss. Macular holes can be treated~     by surgically removing the vitreous gel and injecting intraocular gas. Following macular hole~     surgery, face-down positioning is often advised with the aim of improving the likelihood of~     macular hole closure. The current evidence of postoperative positioning protocols is~     insufficient to draw firm conclusions and guide practice. The investigators wish to compare~     non-face-down positioning and face-down positioning after surgery for macular holes in a~     randomized trial.~      Hypothesis: Non-face-down positioning is equivalent to face-down positioning after surgery~     for macular holes.~   "
121718|NCT01974297|"~     The purpose of this study is to compare combination atorvastatin/fenofibric acid 10/135mg~     with atorvastatin 20mg monotherapy in the mixed hyperlipidemia who were not at lipid goals~     with atorvastatin 10mg monotherapy.~   "
121719|NCT01974284|"~     We assess the effectiveness of percutaneous ethanol ablation for the treatment of thyroid~     cancer.~   "
121720|NCT01974271|"~     This prospective, multicenter, observational study will evaluate the impact of comorbidities~     on hemoglobin stability in chronic kidney disease patients on dialysis treated with Mircera~     (methoxy polyethylene glycol-epoetin beta). Eligible patients will be followed for 6 months~     of treatment.~   "
121721|NCT01974258|"~     This study will evaluate the maximum tolerated dose and dose-limiting toxicities of~     vemurafenib and/or cobimetinib when used with onartuzumab in cancer patients.~   "
121722|NCT01974245|"~     Hypovitaminosis D is highly prevalent among patients with chronic kidney disease, especially~     in those undergoing dialysis. The loss of protein to the dialysis solution seems to~     contribute significantly to the reduced serum levels of vitamin D in these patients. As a~     result of the disease and the dialysis procedure, there is high prevalence of chronic~     inflammation and high risk of infections. There is evidence in other populations, that~     vitamin D has immunomodulatory effects by stimulating the production of cathelicidin, an~     antimicrobial peptide and suppressing the production of proinflammatory cytokines. Thus, this~     study aims to investigate the effects of cholecalciferol supplementation on immunological~     markers in patients in hemodialysis and peritoneal dialysis with hypovitaminosis D . This is~     a randomized, double-blind, placebo-controlled trial in which patients who have vitamin D~     deficiency [25 (OH) D <20 ng / mL] will be allocated to the intervention group~     (cholecalciferol) or control (placebo). Patients will receive supplemented 100,000 IU / week~     cholecalciferol a period of 12 weeks. Before and after the intervention will be determined~     25(OH)D, cathelicidin, interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α) and C-reactive~     protein serum. In monocytes, we will evaluate cathelicidin, IL-6 and TNF-α, 25(OH)D receptor~     and α 1-hydroxylase enzyme expression.~   "
121723|NCT01974232|"~     This is a retrospective analysis of children (≤21years old) who received clinical treatment~     with either Romiplostim or Eltrombopag at 2 medical centers from 2009-2013. The children~     included in this study were from Weill Medical College of Cornell University, New York, New~     York and Children's Hospital Orange County, Orange, California~   "
121724|NCT01974219|"~     In cigarette smokers that are HIV+, one of the most common HIV-associated non-AIDS conditions~     is the accelerated development of chronic obstructive pulmonary disease (COPD), a disorder~     associated with significant morbidity and mortality. Based on the knowledge that COPD in~     smokers starts in the small airway epithelium, this study is focused on examining the~     hypothesis that the accelerated development of COPD associated with HIV infection results, in~     part, from an interaction of HIV directly on the small airway epithelium or through infection~     of cellular components of the immune system, with mediators released by these immune cells~     evoking premature biologic aging of the small airway epithelium. By identifying the early~     events in the pathogenesis of the HIV-associated accelerated COPD in smokers, we aim to~     identify biologic targets to which pharmacologic therapies could be addressed.~   "
121725|NCT01974206|"~     The purpose of this study is to evaluate the efficacy of ASP0113 compared to placebo in~     reducing the incidence of cytomegalovirus (CMV) viremia in CMV-seronegative subjects~     receiving a kidney from a CMV-seropositive donor. This study will also evaluate the safety of~     ASP0113 in this patient population.~   "
121762|NCT01973725|"~     Phase II Study of Icotinib Hydrochloride in Treating Patients With Recurrent or Metastatic~     Esophageal Squamous Carcinoma After Failure of Conventional Chemotherapy.~   "
143909|NCT01683682|"~     To investigate the maximum tolerated dose of BIBF 1120 and safety in escalating doses~     administered with Vinorelbine i.v. and Carboplatin i.v. in elderly patients with advanced~     Non-Small Lung Cancer (Stage IV).~   "
121726|NCT01974193|"~     Pelvic lymph node dissection (PLND) is an important step in the surgical staging and~     treatment of gynecologic malignancies.~      Sometimes, complicated lymphoceles after PLND often delay adjuvant treatment including~     chemotherapy and radiation therapy, which potentially affects the success of cancer~     treatment.~      A number of surgical techniques have developed, but failed to reduce the incidence of pelvic~     lymphoceles after PLND.~      The investigators hypothesized that floseal can prevent lymphoceles in patients with~     gynecologic cancer who has undergone PLND.~      The investigators designed prospective randomized controlled study as a pilot study.~      The investigators will randomly apply floseal to one side of pelvis after bilateral PLND, and~     observe the occurence of pelvic lymphoceles after 6 months later.~   "
121727|NCT01974180|"~     Early changes associated with the development of smoking-induced diseases, e.g., COPD and~     lung cancer (the two commonest causes of death in U.S.) are often characterized by abnormal~     airway epithelial differentiation. Airway basal cells (BC) are stem/progenitor cells~     necessary for generation of differentiated airway epithelium. Based on our preliminary~     observations that epidermal growth factor receptor, known to regulate airway epithelial~     differentiation, is enriched in BC and its ligand EGF is induced by smoking, we hypothesized~     that smoking-induced EGF alters the ability of BC to form normally differentiated airway~     epithelium. To test this, airway BC will be purified using a cell-culture method established~     in our laboratory and responses to EGF will be analyzed using genome-wide microarrays and an~     in vitro air-liquid interface model of airway epithelial differentiation.~   "
121728|NCT01974167|"~     The purpose of this study is to evaluate the efficacy and safety of eldecalcitol monotherapy~     compared with alfacalcidol monotherapy in patients with glucocorticoid-induced osteoporosis,~     using a randomized, open-label, parallel-group, comparative design.~   "
121729|NCT01974154|"~     Cigarette smoking is the major cause of chronic obstructive pulmonary disease (COPD), the 4th~     cause of mortality in the US. Central to COPD pathogenesis is ciliopathy, dysfunction of~     the airway ciliated cells that mediate transport of mucus to remove inhaled pathogens. The~     focus of this study is to carry out metabolic profiling of banked biologic samples and assess~     the hypothesis that COPD is associated with a unique metabolome in serum and lung epithelial~     lining fluid, and that subsets of the COPD metabolome are linked to the ciliopathy of COPD.~   "
121730|NCT01974141|"~     This study will assess the safety and efficacy of dapsone gel versus vehicle control in~     patients with acne vulgaris.~   "
121731|NCT01974128|"~     The intent of this clinical study is to answer the questions: 1) Is the proposed treatment~     safe? and 2) Is treatment effective in improving cardiac function and clinical outcomes?~   "
121732|NCT01974115|"~     Extracorporeal shock wave therapy (ESWT) has been successfully introduced into the treatment~     of cellulite over the last years. The purpose of this study is to test the following~     hypotheses: (i) cellulite can be efficiently and safely treated using the radial~     extracorporeal shock wave device, Swiss Dolorclast (Electro Medical Systems S.A., Nyon,~     Switzerland); and (ii) the individual clinical outcome of cellulite treatment with ESWT can~     be predicted by means of the patient's individual cellulite grade at baseline, the patient's~     individual age, body mass index (BMI), weight, and/or height.~   "
121733|NCT01974102|"~     The goal of the proposed interdisciplinary study is to assess feasibility of recruiting a~     pilot sample of parents of toddlers and engaging them in a pilot study to test a version of~     mindfulness-based stress reduction (MBSR), an empirically-supported stress-reduction~     intervention, plus nutrition and physical activity counseling for parents of preschoolers~     (aged 2-5); to reduce parent (and child) stress levels; improve parenting; promote healthy~     eating and physical activity in parent and child; and prevent overweight and obesity in~     preschoolers with an obese parent.~   "
121734|NCT01974089|"~     To determine the prevalence of dysphagia among Danish patients hospitalized with pneumonia~     and to test whether it is possible to reduce the swallowing disorders by changing the~     consistence of food and drink. Patients hospitalized in the period from the 1st of September~     2013 to the 31st of March 2014 will be tested by an occupational therapist for dysphagia~     within the first 24 hours of their hospitalization. The endpoints will be number of~     hospitalization days, rehospitalisation and mortality. If the test is positive, the patient~     will get a diet of a manageable consistency to avoid dysphagia.~   "
121735|NCT01974076|"~     This study will investigate whether transcranial direct current stimulation (tDCS) can~     enhance the efficacy of cognitive behavioural therapy for the treatment of depression.~   "
121736|NCT01974063|"~     Cigarette smoking evokes major changes in the biology of the airway epithelium, the cell~     population that takes the brunt of the stress of cigarette smoke and the cell population~     central to the pathogenesis of chronic obstructive pulmonary disease (COPD) and lung cancer.~     The focus of this study is to identify the differences that two popular alternative nicotine~     delivery strategies, shisha and electronic cigarettes, have on the airway epithelium compared~     to cigarette smoking. We hypothesize that both alternative nicotine delivery strategies~     disorder airway epithelial biology, but in different ways than does cigarette smoking.~   "
121737|NCT01974050|"~     In this study, the investigators will prospectively assess fever rates and other adverse~     events in pregnant women after administration of inactivated influenza vaccine (IIV) using~     text messaging. The investigators hypothesize that women <20 weeks gestational age who~     receive IIV will be willing to enroll in a text messaging-based vaccine adverse event~     monitoring program and will use it to report fever in the post-vaccination period as well as~     continue to text pregnancy-related outcomes through the end of their pregnancy.~   "
121738|NCT01974037|"~     Excess dietary salt intake is closely associated with the development of hypertension and~     cardiocerebral vascular diseases. Preference of high salt diet might involve salty gustatory~     cortices change. This study focuses on examining the neuroimaging changes of salty gustatory~     cortices under different concentration of NaCl solution with or without capsaicin~     intervention through brain PET/CT scan.~   "
121739|NCT01974024|"~     The aims of this study were to investigate the feasibility of methylprednisolone rotation as~     treatment of DIH.~   "
121786|NCT01973400|"~     Given that the tocotrienols have been shown to possess neuroprotective effects and that both~     type 1 and type 2 diabetes can lead to peripheral neuropathy and cognitive impairment, the~     present study aims to determine the beneficial effects of tocotrienols in ameliorating such~     neurological related events in both type 1 and type 2 diabetic patients.~   "
121740|NCT01974011|"~     Dorsal penile nerve block (DPNB) is a regional nerve block probably most often performed~     throughout the world. There are several different methods described in the literature. When~     compared to penile ring wall infiltration or caudal block, the Dorsal penile nerve block~     (DPNB) is more likely associated with the risk of failure of the block quality. The aim of~     this study is to compare the quality of the standard method of Dorsal penile nerve block~     (DPNB)(Dalens' technique) with that of a modified procedure (Dorsal penile nerve block~     (DPNB)with additional infiltration of the ventromedial penis at the transition between the~     penis and the scrotum.~   "
121741|NCT01973998|"~     Background: COPD exacerbations add considerably to patients' burden because they: (1) cause~     frequent hospital admissions and relapses or readmissions, (2) contribute directly to the~     death of many patients, either during hospitalization or shortly thereafter, (3) cause~     patients significant stress, prolonged physical discomfort, disability and dramatically~     reduced quality of life, (4) consume the majority of the resources available to manage this~     chronic condition, (5) frequently progress to a severe stage warranting hospitalization~     before any abortive treatment is instituted, and (6) may hasten the progressive loss of lung~     function, a steady decline that is a cardinal feature of COPD itself. Hence, investigations~     of new therapies to treat COPD patients who are hospitalized with a severe exacerbation are~     desperately needed.~      Objective: To test the feasibility of roflumilast to decrease all cause readmission and~     mortality 180 days after hospitalization for acute COPD exacerbation.~      Methods: Parallel-group, prospective, randomized, double blind, placebo-controlled trial of~     roflumilast 500 ug daily vs. placebo in approximately 100 hospitalized AECOPD patients.~     Inclusion Criteria. Primary diagnosis of AECOPD; admission to the hospital <12 hours; patient~     age >40, < 80 years old; cigarette smoking > 10 pack-years. Exclusion Criteria. Prior~     diagnosis or high suspicion for asthma; pulmonary edema, pneumonia, interstitial lung disease~     or significant bronchiectasis; intubated and mechanically ventilated at the time of~     evaluation; active liver disease, or transaminase elevations (> 3xULN); history of heavy~     ethanol use; history of suicidal behavior ≤ 2 years or suicidal ideation ≤ 6 months prior to~     enrollment; pregnant or lactating females. Those on the following excluded medications: P450~     inducers and CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2~     simultaneously~   "
121742|NCT01973985|"~     Pleural effusion is an extremely common problem with multiple causes; its subsequent~     investigation with thoracocentesis and treatment with drainage represent two of the most~     frequently performed diagnostic and therapeutic medical procedures. The role of thoracic~     ultrasonography in the management of pleural effusion is a modern and rapidly expanding one,~     having become effectively mandatory and part of the gold standard over the past decade due~     to its diagnostic and patient safety benefits. By contrast, the measurement of intra-pleural~     pressure using sequential manometry has failed to convincingly demonstrate its clinical value~     beyond physiological studies despite its availability for over a century. Previous work has~     shown a potential role for pleural manometry in predicting the presence of un-expandable lung~     and success of talc pleurodesis but these studies have not been replicated or clinically~     validated.~      We intend to combine the old and new in an observational study comparing findings on thoracic~     ultrasonography and pleural manometry during thoracocentesis with patient-reported symptoms~     and the key clinical outcomes of presence of un-expandable lung and success of talc~     pleurodesis. The investigators hypothesise that the previously described variations in~     pleural elastance can be correlated with appearances and anatomical changes visualised on~     thoracic ultrasonography; and in combination can be reliably utilised to predict clinical~     outcome. The study may allow the proposal of a treatment algorithm that allows patients with~     pleural effusion to be managed in a more expeditious and efficient manner.~   "
121743|NCT01973972|"~     The proposed research will test a novel program that combines intensive weight management~     with shared (group) medical appointments for patients with diabetes. This research is~     important because diabetes is increasingly prevalent, it requires complex management by the~     provider and the patient, and weight loss is a critical component of its management. Adding~     weight management to shared medical appointments could potentially improve blood sugar~     control while reducing medications and their side effects such as low blood sugar.~   "
121744|NCT01973959|"~     Anaesthesiology plays a key role in promoting safe perioperative care. This includes the~     perioperative phase in the post-anaesthesia care unit (PACU) where problems with incomplete~     information transfer may have a negative impact on patient safety and can lead to patient~     harm. The objective of this study is to analyse information transfer during postoperative~     handovers in the PACU.~      With a self-developed checklist information transfer during postoperative handovers will be~     documented and subsequently compared with patient information in anaesthesia records.~   "
121745|NCT01973946|"~     The purpose of this prospective trial is to test a daily telephone based automated symptom~     monitoring and response system to track and further treat unrelieved symptoms for patients~     living at home during chemotherapy treatment as compared with usual care which consists of~     patients calling their oncology provider for symptom concerns.~   "
121746|NCT01973933|"~     This study aims to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of~     pyrimethamine and metformin IR after oral administration in healthy male volunteers.~   "
121747|NCT01973920|"~     Diabetes mellitus (DM) is a chronic disease of carbohydrate, fat, and protein metabolism~     caused by an absolute or relative deficiency of insulin, an anabolic hormone. The current~     methods of insulin therapy for diabetic patients are multiple daily injection therapy and~     continuous subcutaneous insulin infusion with an external pump. This rout of administration~     may lead to hyperinsulinemia as insulin is administered in a non physiological way, targeting~     mainly extra hepatic tissues (muscle, fat). A method of providing insulin without the need~     for injections has been a goal in drug delivery.~      Oshadi Drug Administration Ltd. has developed oral carrier for proteins based on biochemistry~     and quantum theory of biochemical reactions. The carrier enables the absorption of proteins~     from the gastrointestinal tract in their full structure. Oshadi has also developed the Oshadi~     Icp - insulin, proinsulin and C-peptide in Oshadi carrier, administrated orally. This study~     was design in order to evaluate the safety and feasibility of multiple administrations of~     Oshadi Icp for home use. The study will be a multiple-dose, open-label non-randomized study~     in patients with Type 1 diabetes, with periodic dose adjustments. The study will include 4~     weeks of multiple-dose administration of Oshadi oral insulin (Oshadi Icp) at home and in~     study center for the determination of the efficacy, safety and pharmacodynamic effects of~     Oshadi Icp.~   "
121787|NCT01973387|"~     The purpose of this study is to evaluate the efficacy and safety of ibrutinib versus~     rituximab in adult Asia Pacific region patients with relapsed or refractory chronic~     lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).~   "
121748|NCT01973907|"~     The purpose of the SQUEEZE Trial is to determine which fluid resuscitation strategy results~     in the best outcomes for children treated for suspected or confirmed septic shock. In this~     study, eligible children will be randomized to either the 'Usual Care Arm' or the 'Fluid~     Sparing Arm'. Children will receive treatment according to current ACCM Septic Shock~     Resuscitation Guidelines, with the assigned resuscitation strategy used to guide~     administration of further fluid boluses as well as the timing of initiation and escalation of~     vasoactive medications to achieve ACCM recommended hemodynamic targets.~   "
121749|NCT01973894|"~     This study investigates what independent variables may influence Midazolam Pharmacokinetics~     in critically ill patients.~   "
121750|NCT01973881|"~     This study is for the development and validation of functional magnetic resonance imaging~     (MRI) parameters as biomarkers for analyzing extent of disease and quantifying response to~     treatment in patients with myelofibrosis.~   "
121751|NCT01973868|"~     To establish safety, tolerability and pharmacokinetics of regorafenib and cetuximab in~     combination, and to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose~     (RP2D)~   "
121752|NCT01973855|"~     To meet eligibility criteria, this study and informed consent of the syndrome of fever~     associated with bleeding of infectious diseases, severe patients to carry out multicenter,~     practical randomized controlled clinical research, to compare the curative effect of western~     medicine, combining Chinese and western medicine treatment, and security, and pathogenesis of~     TCM and syndrome, severe immune related factor and syndrome type of traditional Chinese~     medicine, Chinese medicine prescriptions mechanism research.~   "
121753|NCT01973842|"~     The present study aims to investigate whether the dosage of the GnRH agonist used for~     triggering final oocyte maturation affects the maturity of the oocytes retrieved in high risk~     for OHSS patients undergoing ovarian stimulation for IVF using GnRH antagonists and~     recombinant FSH.~   "
121754|NCT01973829|"~     The purpose of the study is to test whether the health care provider access and training in~     CERTAIN (Checklist for Early Recognition and Treatment of Acute Illness), would facilitate~     timely and error free best-practice delivery and minimize preventable death and costly~     complications in critically ill patients.~   "
121755|NCT01973816|"~     The purpose of this study is to determine whether, in women with deep endometriosis involving~     the rectum and not intending to get pregnant, continuous hormonal treatment would be followed~     by better digestive functional outcomes than curative rectal surgery. Are included women from~     35 to 50 years presenting with deep endometriosis infiltrating at least the muscular layer of~     the rectum and not having pregnancy intention.~      The main outcome concerns the quality of digestive function 24 after the onset of the~     treatment, assessed using a composite variable: patient considering that digestive function~     is normal AND the Knowles-Eccersley-Scott-Symptom Questionnaire (KESS score) <7 AND the~     Gastrointestinal Quality of Life Index (GIQLI) score >100.~      Secondary outcomes are: presence of severe constipation, increased frequency of daily bowel~     movements, anal incontinence, postoperative dysuria, Biberoglou & Behrman score, quality of~     life SF36 score, KESS score, GIQLI, Wexner score of anal continence, Bristol stools score,~     the rate of postoperative complications, medical treatment adverse outcomes, the rate of~     additional endoscopic and surgical procedures.~      The randomization is central, once the physician asses the diagnosis, explain the study's~     principle and rece In the arm A, the patients received triptoreline and add back therapy by~     estradiol during 6 months, followed by daily intake of cyproterone acetate and add back~     therapy during 18 months.~      In the arm B, patients are managed by rectal surgery (depending on the surgeon choice: rectal~     shaving, rectal disc excision or colorectal resection) followed by the prevention of~     recurrences by daily intake of cyproterone acetate and add back therapy during 18 months.~      The number of subjects required is 78 (39 on each arm). Inclusions period is estimated at 24~     months. The length of the follow up is 24 months. The patients have 8 visits in the arm A,~     and 7 visits in the arm B.~      Eleven French tertiary referral centres will enrol patients in the trial.~   "
121756|NCT01973803|"~     This study is to evaluate the performance of the Articulinx ICMC~     (InterCarpoMetacarpalCushion) in the carpometacarpal joint (CMC joint) and to describe the~     clinical results in patients who have been treated with this device. Expected results include~     the relief of symptoms and improvement of function in patients with symptomatic~     osteoarthritis (OA) of the CMC-1 joint. Evaluation of device performance will be achieved~     through measurements of pain, pain medication use, and joint function in up to 40 subjects.~     Each subject will be compared to their pre-surgery status for each endpoint.~   "
121757|NCT01973790|"~     The primary objective of this study is to evaluate the long-term safety of 100 mg Z-338 TID~     in European subjects with FD.~   "
121758|NCT01973777|"~     The IUB (Intrauterine ball) is a copper releasing intrauterine contraceptive device~     consisting of copper beads on a flexible NiTinol wire. It was designed to reduce the pain and~     bleeding caused by traditional T-shaped copper IUDs and to reduce expulsions. In an initial~     pilot of 15 women, there were no complications during the 12 months. This observational pilot~     study of 50 women will determine that the early expulsion rate is not greater than 10% and~     that there is patient and physician acceptance, so that we can plan a larger randomized~     controlled trial for efficacy and safety.~   "
121759|NCT01973764|"~     Puncture of the ventricular system is one of the most frequently performed neurosurgical~     interventions. This procedure is commonly performed in order to treat and/or measure~     pathologically elevated intracranial pressure.Therefore a safe and fast surgical procedure is~     needed. Currently the landmark-based placement of intraventricular catheters is the gold~     standard. However it is known that more than 60% of the catheters are not accurately placed~     in accordance with landmark-based procedures. When the catheter is not placed accurately~     multiple punctures may be required. In this study, the investigators aim to investigate~     prospectively whether ultrasound guidance leads to a lower number of incorrect catheter~     placements, and whether this guidance consequently decreases the number of punctures.~   "
121760|NCT01973751|"~     Novel asthma biomarkers to predict the response to inhaled corticosteroid Brief description:~     This will be a single center study of asthmatic subjects and healthy controls which will~     investigate mechanisms underlying different response to inhaled corticosteroid, the mainstay~     of asthma therapy. Only about half of the asthmatic patients have improved lung function~     after treatment of inhaled corticosteroid. The investigators hypothesize that there are~     biomarkers such as epithelial cytokines (IL-25, IL-33, TSLP) in airway tissues or plasma of~     asthmatic patients which could predict the response of asthmatic patients to inhaled~     corticosteroid. Finding novel asthma biomarker will help the clinicians to choose the optimal~     treatment for individual asthmatic patient.~   "
121761|NCT01973738|"~     Although there are two kinds of selective estrogen receptor modulator (SERM) :raloxifene~     (RLX) and bazedoxifene (BZA), the difference is still unclear. In this study, we plan to~     compare clinical efficacy and safety between RLX and BZA.~   "
121763|NCT01973712|"~     A periprosthetic distal femur fracture is a fracture close to a knee implant. This type of~     fracture is often difficult to fix because of the close proximity of the two surgical~     implants which can sometimes interfere with proper bone healing. Improper healing can cause~     significant impairment and sometimes requires additional surgeries to correct the problem.~     Despite considerable interest and research put into developing techniques to repair this~     fracture surgeons do not know which is the best way to treat this type of fracture.~      Our multicentre orthopaedic study group is conducting this study to compare two standard, but~     different treatments for periprosthetic distal femur fractures. One treatment consists of~     open surgery and the placement of a plate and screws along the side of the femur. The other~     consists of implanting an intramedullary nail in the femur.~      The goal of this study is to directly compare the two treatments to see if one treatment~     results in better patient outcomes than the other.~   "
121764|NCT01973699|"~     Adequate visualization during shoulder arthroscopy is of great importance for the procedure~     to be efficiently and effectively performed. The use of dilute epinephrine in irrigation~     fluid has been historically utilized to help with visualization. Given the potential safety~     issues documented in the literature related to epinephrine use, as well as the significant~     improvements in technique and instrumentation over the last decade, the need for this~     additive should be reexamined. The objective of the current study was to compare surgeon~     determined visualization in shoulder arthroscopy using irrigation fluid with and without~     epinephrine.~   "
121765|NCT01973686|"~     The aim of the present study is to investigate the changes in body composition and the degree~     of compensation to exercise induced energy expenditure after 1 year of physical activity with~     either moderate or vigorous intensity in overweight and class 1 obese men and women. The~     present study is a sub study to main study Active Commuting To Improve Well-being and Health~     in Everyday Life (NCT 01962259)~   "
121766|NCT01973673|"~     Prostate cancer patients receiving hormone treatment (androgen deprivation therapy, or ADT)~     are at increased risk of developing bone loss and osteoporosis as side effects. To prevent~     this, guidelines recommend participation in healthy bone behaviours including weight-bearing~     exercise and adequate calcium/vitamin D intake. However, prior studies have shown that~     patients are not regularly screened or counselled regarding healthy bone behaviours while~     receiving ADT. Maintaining bone health in prostate cancer patients is important because men~     on ADT are at increased risk of fractures. In this study, the investigators will examine~     whether an intervention designed to improve healthy bone behaviours among prostate cancer~     patients on ADT can be implemented. The intervention consists of a written healthy bones~     prescription, brief verbal counseling, and printed educational materials for participants.~     Investigators hope to obtain an initial estimate of whether the intervention works. They also~     hope to show that this simple intervention can be implemented in a real, working cancer~     clinic.~      The investigators hypothesize that an intervention to improve bone health in prostate cancer~     patients receiving ADT (healthy bones prescription, verbal counseling, and printed~     educational materials) is effective, implementable, and accepted by clinicians and patients.~   "
121767|NCT01973660|"~     Non-randomized, open label, multicentric translational research study in women with untreated~     invasive breast carcinoma eligible for primary surgery (Stage I-IIIA).~      The aim of PAMELA is to test the hypothesis that PAM50 HER2-enriched (HER2-E) subtype better~     predicts response to neoadjuvant dual anti-HER2 blockade, with or without endocrine therapy,~     compared to traditional clinical HER2 classification. Furthermore, we posit that~     characterization of gene expression patterns may identify profiles of those who may be safely~     spared chemotherapy.~   "
121768|NCT01973647|"~     Difficulty falling asleep, staying asleep or poor quality sleep (insomnia) is common in~     people with chronic obstructive pulmonary disease. Insomnia is related to greater mortality,~     with four times the risk of mortality for sleep times < 300 minutes. Insomnia is also related~     to greater morbidity, with 75% greater health care costs than people without insomnia.~     However, insomnia medications are used with caution in COPD due to potential adverse effects.~     Common features of COPD such as dyspnea, chronic inflammation, anxiety and depression also~     affect insomnia and can interfere with therapy outcomes. While cognitive behavioral therapy~     for insomnia (CBT-I), a therapy that provides guidance on changing unhelpful sleep-related~     beliefs and behavior, is effective for people with primary insomnia and people with other~     chronic illnesses, the efficacy and mechanisms of action of such a therapy are yet unclear in~     people with both insomnia and COPD. The objective in this application is to rigorously test~     efficacy of two components of insomnia therapy - CBT-I and COPD education (COPD-ED) - in~     people with coexisting insomnia and COPD, and to identify mechanisms responsible for therapy~     outcomes. The central hypothesis is that both CBT-I and COPD-ED will have positive, lasting~     effects on objectively and subjectively measured insomnia and fatigue. The rationale for the~     proposed study is that once the efficacy and mechanisms of CBT-I and COPD-ED are known, new~     and innovative approaches for insomnia coexisting with COPD can be developed, thereby leading~     to longer, higher quality and more productive lives for people with COPD, and reduced~     societal cost due to the effects of insomnia. The investigators plan to test our central~     hypothesis by completing a randomized controlled comparison of CBT-I, COPD-ED and non-COPD,~     non-sleep health education attention control (AC) using a highly efficient 4-group design.~     Arm 1 comprises 6 weekly sessions of CBT-I+AC; Arm 2=6 sessions of COPD-ED+AC; Arm~     3=CBT-I+COPD-ED; and Arm 4=AC. This design will allow completion of the following Specific~     Aims: 1. Determine the efficacy of individual treatment components, CBT-I and COPD-ED, on~     insomnia and fatigue. 2. Define mechanistic contributors to the outcomes after CBT-I and~     COPD-ED. The research proposed in this application is innovative because it represents a new~     and substantive departure from the usual insomnia therapy, namely by testing traditional~     CBT-I with education to enhance outcomes.~   "
121769|NCT01973634|"~     Whole breast irradiation (WBI) after breast conserving surgery for early-stage breast cancer~     halves the recurrence risk and reduces the breast cancer death by about one sixth. A~     sequential boost (SeqB) dose to the tumour bed further improves local control, but also~     increases the risk of late skin toxicity and cosmetic changes. At Ghent University Hospital~     WBI is prescribed in 15 fractions of 2.67 Gy according to the START-B hypofractionation~     scheme. A sequential boost is typically given in 4 to 8 extra fractions which prolongs the~     overall treatment time. The boost dose can also be delivered within the 15 fractions of WBI,~     the so-called simultaneous integrated boost (SIB). SIB shortens the overall treatment time~     which is convenient for the patient and the radiotherapy department. In this study we wish to~     test the hypothesis of acceptable skin toxicity and reduced cost with SIB using~     hypofractionated prone intensity modulation radiotherapy IMRT with topographical dose~     painting, a technique recently developed in our group. Patients are randomized between SeqB~     and SIB.~   "
121770|NCT01973608|"~     This is a Phase 2a, open-label, parallel group, partly randomized dose escalation trial to~     assess the safety and efficacy of a low dose, an intermediate dose, and high dose MSB0010445~     given by intravenous infusion to subjects with advanced (unresectable or metastatic) melanoma~     in combination with stereotactic body radiation therapy (SBRT).~   "
121834|NCT01972776|"~     This was a 2 Part study. Part 1 was a safety and tolerability study in GOLD I-III COPD~     patients. Part 2 was an efficacy study in GOLD I-III COPD patients.~   "
121772|NCT01973582|"~     Taiwan has launched a successful nationwide neonatal hepatitis B immunization since July 1,~     1984. It successfully decreased the incidence of hepatitis B virus infection, the hepatitis B~     carrier rate as well as liver diseases among children and adolescents. The sexual~     transmission route is another important way of hepatitis B infection aside from the mother~     and child vertical infection, especially for youth and adults. Hepatitis B vaccination cohort~     refers to those who were born after 1986 and received hepatitis B vaccine immunization during~     newborn period. They are gradually entering into young adults and adolescent age. Among them,~     there is no empirical evidence to show the actual infection rate and to help implement~     hepatitis B vaccine booster policy for those who had three seronegative viral markers of~     hepatitis B. Therefore, the study design is to collect three consecutive years graduate~     school students school entry health examination data and undergo three hepatitis B viral~     markers checkup and blood types. The data linkage includes their health checkup data in the~     freshmen period, Taiwan CDC databank for neonatal hepatitis B immunization records, pregnancy~     and birth record registry, Taiwan cancer registry and Taiwan death record registry.~   "
121773|NCT01973569|"~     To evaluate the inhibitory effect of progression, compared with placebo, in joint destruction~     by AMG 162 administered subcutaneously to rheumatoid arthritis patients~   "
121774|NCT01973556|"~     Patients managed by a newly formed pharmacist-physician medication therapy management team in~     a university primary care clinic will have better blood pressure control than patients~     receiving usual care.~   "
121775|NCT01973543|"~     Safety study of AADC gene transfer (VY-AADC01) in subjects with Parkinson's disease.~   "
121776|NCT01973530|"~     We hypothesize continuous adductor canal block with steroid adjuvant would offer no inferior~     analgesics and rehabilitation ability than continuous femoral nerve block for postoperative~     patients receiving total knee arthroplasty.~   "
121777|NCT01973517|"~     Feraheme (ferumoxytol) is FDA-approved for iron supplementation and is composed of iron oxide~     nanoparticles classified among the ultra-small superparamagnetic iron oxides (USPIO). In this~     project we hypothesize that Feraheme could become a sensitive and specific marker of active~     inflammation in multiple sclerosis. We will explore this hypothesis taking advantage of ultra~     high field strength (7T) MRI to further increase the effectiveness of the contrast agent~     Feraheme at revealing inflammatory activity.~   "
121778|NCT01973504|"~     MP4OX is being developed as an ischemic rescue therapy to perfuse and oxygenate tissues at~     risk during hemorrhagic shock. MP4OX is a pegylated hemoglobin-based colloid designed to~     improve perfusion and target delivery of oxygen to ischemic tissues. This study will evaluate~     safety and efficacy of MP4OX treatment, in addition to standard therapy, in trauma patients~     suffering from lactic acidosis due to severe hemorrhagic shock.~   "
121779|NCT01973491|"~     This is a multi-center, open-label, single arm, baseline-controlled Phase 2a trial to~     evaluate the clinical and biological effects of ATX-MS-1467 in subjects with relapsing~     multiple sclerosis (MS) and to assess the maintenance of any such effects.~   "
121780|NCT01973478|"~     Major depressive disorders are real public health issues in terms of diagnosis and treatment.~     Some forms of depression are chronic and resistant to treatment (TRD). In these forms suicide~     risk is important.~      Patients with TRD are potential candidates for neurosurgical interventions to treat~     depression. However, psychosurgery interventions based upon lesions, showed their limitations~     related to 1. the large variability in neurosurgical gestures, 2. their side effects, and of~     course 3. the irreversible damage caused by the surgery.~      Thus, deep brain stimulation (DBS) could represent an opportunity for patients suffering from~     TRD. Our preliminary study based upon the stimulation of the accumbens nucleus showed~     encouraging results. The investigators have thus planned a randomized controlled trial versus~     sham stimulation to confirm the therapeutic value of nucleus accumbens DBS.~   "
121781|NCT01973465|"~     This study was developed in response to the July, 2013 FDA draft guidance regarding FMT for~     CDI. The weight of the evidence in the literature suggests that FMT is the most effective~     treatment for ambulatory outpatients affected by recurrent CDI who fail conventional therapy.~      The anticipated benefits to research patients enrolled in this study include resolution of~     chronic diarrhea, return of bowel habits and nutritional status to normal, and resolution of~     chronic recurrent CDI.~      FMT involves the endoscopic instillation of freshly obtained stool with millions of live~     bacteria into the recipient's colon by endoscopic lavage. With any endoscopic procedure,~     there is a risk of perforated viscous. This is very rare, but the risk is increased with~     severe CDI. The risk of acquisition of communicable enteric or blood borne pathogen appears~     to be negligible.~   "
121782|NCT01973452|"~     The purpose of this study is to see if the drug, Dexmedetomidine (also known as Precedex),~     can reduce pain for patients having Thoracic Surgery and therefore reduce the amount of~     opioid drug needed after surgery. It is a drug that is already approved by the FDA (Food &~     Drug Administration) for use as a sedative in hospitals and is currently used in the~     investigators Intensive Care Unit for this purpose. The investigators want to investigate if~     it also has pain relieving properties.~   "
121783|NCT01973439|"~     To compare the plasma pharmacokinetic (PK) parameters of q24h versus q12h dosing of abacavir~     in HIV-1-infected infants and children aged 3 months to 36 months~      The secondary objectives of PENTA15 were:~      To compare the plasma PK parameters of q24h versus q12h dosing of lamivudine in~     HIV-1-infected infants and children aged 3 months to 36 months who were receiving lamivudine~     in combination with abacavir~      To compare age-related differences in the PK parameters of q24h versus q12h dosing of~     abacavir and lamivudine infants and children in 3 age groups (≥3 to <12 months, ≥12 to <24~     months and ≥24 to <36 months)~      To describe child and family acceptability of and adherence to q24h compared to q12h dosage~     regimens of abacavir and lamivudine~   "
121784|NCT01973426|"~     We plan to investigate whether the Isolated Orthosis for Thumb Actuation (IOTA) can~     effectively facilitate the ability of participants to perform a specific set of clinically~     relevant tasks conducted in a clinic setting.~   "
121785|NCT01973413|"~     The primary goal is to test the function of the Diabetes Assistant (DiAs) enhanced~     control-to-range (CTR) controller in a closely monitored diabetes camp setting. The camp~     setting will allow us to obtain pilot efficacy data.~   "
143951|NCT01683123|"~     Analyze the results of conditioning with once-daily dose intravenous busulfan and fludarabine~     in patients undergoing HLA identical sibling Allogeneic HSCT for myeloid malignancies.~   "
121788|NCT01973374|"~     Maternal diabetes in pregnancy can negatively impact fetal well-being and contribute to~     adverse pregnancy outcomes. Much of the morbidity associated with diabetes in pregnancy can~     be minimized with tight glucose control. A number of studies in non-pregnant populations have~     highlighted the feasibility, acceptability and efficacy of text messaging interventions for~     improving diabetic compliance and control. This study will investigate whether a text~     messaging intervention is feasible and effective in an urban, diabetic, obstetric clinic and~     whether this intervention can improve compliance with diabetes care, glucose control and~     pregnancy outcomes. The study will also assess satisfaction with the intervention itself.~   "
121789|NCT01973361|"~     The UltraHeal Study is a randomized controlled trial to compare healing response of low~     frequency contact ultrasonic-assisted debridement in addition to best practice wound care to~     best practice wound care alone in a Vascular Surgery Clinic patient population with wounds of~     the lower extremity.~   "
121790|NCT01973348|"~     Electronic eyeglasses, Amblyz™glasses, are a new medical device designed to treat amblyopia,~     which intermittently become opaque and provide effective occlusion for 50% of the time they~     are worn. A non-randomized study reported that Amblyz glasses yield an improvement in the~     amblyopic eye and offer an alternative effective treatment. We are unaware of any randomized~     clinical trial reports of response to AmblyzTM glasses treatment of amblyopia.~      Our hypothesis: Amblyz™glasses can improve visual acuity of the amblyopic eye as effective as~     traditional patching treatment.~      The primary objective is to determine if AmblyzTM equally treats moderate amblyopia as the~     standard 2-hour patching treatment and AmblyzTM equally treats severe amblyopia as the~     standard 6-hour patching treatment.~      This study is designed to evaluate the effectiveness of a novel amblyopia treatment, AmblyzTM~     glasses, in treating amblyopia.~      Moderate amblyopia: Children ages 3 to <8 years with visual acuity of 20/40 to 20/80 in the~     amblyopic eye will be enrolled and randomized into two groups: 4-hour AmblyzTM glasses~     treatment group and standard 2-hour patching control group.~      Severe amblyopia: Children ages 3 to <8 years with visual acuity of 20/100 to 20/400 in the~     amblyopic eye will be enrolled and randomized into two groups: 12-hour AmblyzTM glasses~     treatment group and standard 6-hour patching control group.~   "
121791|NCT01973335|"~     This study has two primary objectives:~        1. To compare combination therapy with acetazolamide and low-dose loop diuretics versus~          high-dose loop diuretics (standard of care) in patients with acute decompensated heart~          failure at high risk for diuretic resistance.~        2. To demonstrate the safety and efficacy of upfront therapy with spironolactone in~          addition to loop diuretic therapy in patients with acute decompensated heart failure at~          high risk for diuretic resistance.~   "
121792|NCT01973322|"~     Title: Vaccination with autologous dendritic cells loaded with autologous tumor lysate or~     homogenate combined with immunomodulating radiotherapy and/or preleukapheresis IFN-alfa in~     patients with metastatic melanoma: a randomized proof-of-principle phase II study.~      Study Design: Randomized selection design, proof of principle study Study Duration: 36 months~     Number of Subjects: 24 evaluable patients~      Diagnosis and Main Inclusion Criteria: Patients with non resectable stage III or stage IV~     malignant melanoma carrying at least 2 measurable lesions, any line after 1st line~     Vemurafenib in patients carrying BRAF mutation-positive melanoma and/or ≥ 2nd line~     Ipilimumab.~      Study Product, Dose, Route, Regimen and duration of administration:~      Intradermal Autologous Dendritic Cell vaccine loaded with autologous tumor lysate or~     homogenate on weeks 1, 4 6 and 8 during induction phase, and every 4 weeks during maintenance~     phase up to a maximum of 14 vaccine doses (each dose followed by IL-2 3 MU day 2-6) COMBINED~     OR NOT WITH~        -  IFN-alfa 3 MU daily for 7 days before leukapheresis AND/OR~        -  Three daily doses of 8 Gy up to 12 Gy delivered to one metastatic field between vaccine~          doses 1 and 2 (optional to one additional field between doses 7 and 8) utilizing~          IMRT-IMAT techniques.~   "
121793|NCT01973309|"~     This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and~     PK of vantictumab when combined with paclitaxel.~   "
121794|NCT01973296|"~     The purpose of this study is to determine whether a new way of educating/coaching chronically~     ill patients discharged from the Emergency Room will help them receive post-ER health care~     and strengthen their links to a regular, personal doctor.~   "
121795|NCT01973283|"~     The goal of this open-administration treatment study of citalopram (or duloxetine) is to~     evaluate the effect of antidepressant medication on treating the syndrome of frailty in~     older adults with depressive symptoms. Patients with significant depressive symptoms (defined~     as CES-D (Center for Epidemiological Studies - Depression scale) > 10) and 1 or more symptoms~     of the frailty syndrome (exhaustion, decreased energy, weight loss, decreased grip strength,~     and slow/unsteady gait) will be evaluated and treated with citalopram (or duloxetine) for 8~     weeks to test whether antidepressant medication improves both the syndrome of frailty and~     depressive symptoms. Patients evaluated at the Adult and Late Life Depression clinic and~     eligible to participate in the study will be treated with an antidepressant medication and~     assessed on the primary outcome variables (characteristics of frailty, depressive symptoms)~     as well as on secondary variables which include cognition (global cognition, episodic memory,~     executive function), and function (physical mobility, instrumental activities of daily~     living, and social functioning) prior to treatment initiation and following 8-weeks of~     treatment. The hypotheses for this protocol predict that we will discover a significant~     improvement on both frailty characteristics and depressive symptoms in this clinical~     population when treated with antidepressant medication (citalopram or duloxetine).~   "
121796|NCT01973270|"~     The purpose of this study is to determine whether cognitive training exercises can improve~     cognitive functioning in young patients with recent-onset schizophrenia, schizoaffective,~     schizophreniform, and psychosis NOS who are being treated in community mental health~     settings. We will investigate the effects of web-based cognitive training exercises delivered~     on a portable laptop computer. The findings will provide us with valuable information on~     whether cognitive training can improve the cognition and functioning of young individuals~     early in the course of schizophrenia.~   "
121797|NCT01973257|"~     The purpose of our study is to evaluate the perfusion of the IVDs and their diffusion ability~     by using the Dynamic contrast-enhanced MR perfusion technique and Diffusion weighted image~     with ADC value measurement, and to determine the relationship between these data and the~     degeneration of IVDs, the different posture, and different stress-loading status.~   "
121798|NCT01973244|"~     This trial is conducted in Europe and Asia. The aim of the trial is to investigate safety,~     tolerability, pharmacokinetics (the exposure of the trial drug in the body) and~     pharmacodynamics (the effect of the investigated drug on the body) of a single dose of~     long-acting growth hormone (NNC0195-0092, somapacitan) compared to daily dosing of~     Norditropin® SimpleXx® (somatropin) in children with growth hormone deficiency.~   "
121799|NCT01973231|"~     This trial is conducted in Europe. The aim of the trial is to investigate the efficacy and~     safety of liraglutide versus lixisenatide as add-on to metformin in subjects with type 2~     diabetes (T2DM).~   "
121800|NCT01973218|"~     The purpose of the study was to assess the immunogenicity and safety of two doses of Novartis~     Meningococcal B Recombinant (rMenB+OMV NZ) vaccine administered one month apart (0, 1 month~     schedule) in Korean adolescents aged between 11 to 17 years.~   "
121801|NCT01973205|"~     The purpose of the study is to evaluate the efficacy and safety of acetaminophen and aspirin~     versus placebo in the acute treatment of migraine~   "
121802|NCT01973192|"~     The purpose of this study is to test the hypothesis that early viral infections alter the~     bacterial flora and inflammatory profile in the airway and accelerate progression of~     pulmonary disease in infants with cystic fibrosis.~   "
121803|NCT01973179|"~     The goal of this observational study is to evaluate the toxicity and local tumor control of~     proton therapy for patients with head and neck cancer in a previously irradiated field.~      Standard of care for recurrent or secondary malignancies in a previously irradiated field is~     surgery. For inoperable patients or residual tumor after surgery, standard of care would be~     palliative chemotherapy. For a small subset of patients (good performance status, small~     radiation fields) re-irradiation can be performed. In this study the established concept of~     re-irradiation with photons will be transferred to proton radiotherapy. Proton therapy has~     the advantage of a steeper dose gradient to normal tissues, thus-theoretical advantages for~     lower toxicity.~   "
121804|NCT01973166|"~     The purpose of this study is to compare the investigational medical grade laser device to a~     marketed medical grade laser device for effectiveness in lightening or clearing unwanted~     tattoos. This study will also compare any side effects from treatment with the devices.~   "
121805|NCT01973153|"~     Leading medical organizations have called on primary care pediatricians to take a central~     role in the prevention of childhood obesity. Weight counseling typically has not been~     incorporated into routine pediatric practice due to time and training constraints. Brief~     interventions with simple behavior change messages are needed to reach high-risk children,~     particularly Latino and Black children who are disproportionately affected by obesity and~     related comorbidities. Steps to Growing Up Healthy (Added Value) is a randomized controlled~     trial testing the efficacy of brief motivational counseling (BMC) delivered by primary care~     clinicians and the added value of supplementing BMC with monthly contact by community health~     workers (CHW) in the prevention/reversal of obesity in Latino and Black children ages 2-4~     years old. Mother-child dyads (targeted n=150) are recruited for this 12-month randomized~     trial at an inner-city pediatric primary care clinic and randomized to: 1) BMC delivered by~     clinicians and nurses at well, sick, and WIC visits with the goal of reducing obesogenic~     behaviors (BMC); 2) BMC plus monthly phone calls by a CHW (BMC+Phone); or 3) BMC plus monthly~     home visits by a CHW (BMC+Home). During BMC, the medical team facilitates the selection of a~     specific goal (i.e., reduce sugar sweetened beverage consumption) that is meaningful to the~     mother and teaches the mother simple behavioral strategies. Monthly contacts with CHWs are~     designed to identify and overcome barriers to goal progress. Dyads are assessed at baseline~     and 12 months and the primary outcome is change in the child's BMI percentile. We hypothesize~     that BMC+Phone and BMC+Home will produce greater reductions in BMI percentiles than BMC alone~     and that BMC+Home will produce greater reductions in BMI percentiles than BMC+Phone.~   "
121806|NCT01973140|"~     Tolvaptan is one of new class of medications approved for treatment of low blood sodium~     (hyponatremia). It works by interfering with the effect of the antidiuretic hormone,~     vasopressin, thereby increasing urine output and decreasing body water. However, the~     magnitude of these effects vary from person to person. Thus, the efficacy of tolvaptan is~     less reliable than an infusion of a concentrated salt solution for emergency, short term~     treatment of hyponatremia.~      This study is designed to test 3 hypotheses about the variable efficacy of tolvaptan.~        1. The variable effect on urine output is due to individual differences in blood~          vasopressin which counteracts the effects of tolvaptan.~        2. The differences in blood vasopressin are due to individual differences in the amount~          secreted in response to a rise in blood sodium.~        3. The variable effect on blood sodium is due mainly to the variable effect on urine output~          and can be corrected by maintaining water intake below urine output.~      The study has 2 parts and will be performed in 12 healthy adult males.~        1. Six subjects will receive tolvaptan at a dose of 60 mg by mouth and six subjects will~          receive tolvaptan at 30 mg by mouth. Blood and urine will be collected hourly for 6~          hours and water will be ingested in prescribed amounts. For the next 16 hours, subjects~          will drink at will and blood and urine will be collected 4 more times.~        2. One week later, the same subjects will receive a concentrated salt solution (3% saline)~          by vein for 6 hours. During this time, blood and urine will be collected hourly but~          drinking will not be permitted. For the next 4 hours, subjects will be allowed to drink~          at will while blood and urine are collected twice more.~      The volume, concentration and creatinine content of each urine will be determined. Blood will~     be analyzed for sodium, vasopressin and, in the first study, tolvaptan.~   "
121807|NCT01973127|"~     The investigators hypothesize that repetitive transcranial magnetic stimulation (rTMS) on the~     right side of the head will make craving towards alcohol less severe in recently detoxified~     alcohol addicted patients.~      Although there are successful treatment option to detoxify patients form their alcohol use,~     many patients tend to relapse. This relapse is mainly caused by a high level of~     (uncontrollable) craving towards alcohol. This aspect of addiction is with the existing~     options hard to treat, there is a great need of new successful treatment modalities. rTMS is~     a FDA approved treatment method for depression. Recently some small scale studies have shown~     promising results on rTMS in the treatment of addiction. In this study the investigators~     focus on alcohol addiction since it is the addiction with the highest morbidity and mortality~     in the Netherlands.~   "
121808|NCT01973114|"~     The purpose of the study is to evaluate the dose regimen, efficacy and safety of latanoprost~     for the treatment of Menière's disease.~   "
121809|NCT01973101|"~     The purpose of this phase II study is to determine the survival free disease of patients~     diagnosed with invasive locally advanced carcinomas of uterine cervix treated with induction~     chemotherapy with cisplatin and gemcitabine followed by chemoradiation and definitive~     chemoradiation.~   "
121810|NCT01973088|"~     This study intends to use in patients with renal tissue and blood samples, screening and~     identification of renal tissue hURAT1 regulating the expression of micro-RNA, for further~     study of uric acid stone formation mechanism and the occurrence of clinical preventive uric~     acid stones provide new clues and new intervention targets.~   "
121811|NCT01973075|"~     Premature Ovarian Insufficiency (POI), first described by Albright in 1942, is defined as an~     increase in Follicle Stimulating Hormone (FSH), an insufficiency of the ovarian function~     leading to an early menopause (<40 years of age).Today, only 35% of POI's etiology can be~     explained. Causes enlightening POI may be enumerated as follows, according to their~     frequency: genetic mutations, autoimmune defects and abnormalities detected on the X~     chromosome.The purpose of the study is to determine the frequency of the genetic~     abnormalities and polymorphisms described above in the POI Turkish population~   "
121812|NCT01973062|"~     This phase II trial studies how well yttrium Y 90 ibritumomab tiuxetan and rituximab work in~     treating patients with recurrent or refractory primary central nervous system non-Hodgkin~     lymphoma. Radiolabeled monoclonal antibodies, such as yttrium 90 ibritumomab tiuxetan, can~     find cancer cells and carry cancer-killing substances to them without harming normal cells.~     Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some~     block the ability of cancer to grow and spread. Others find cancer cells and help kill them~     or carry cancer-killing substances to them. Giving yttrium Y 90 ibritumomab tiuxetan with~     rituximab may kill more cancer cells.~   "
121813|NCT01973049|"~     To demonstrate the effectiveness of DCV 3DAA fixed dose combination with or without Ribavirin~     in treatment naive cirrhotic subjects.~   "
121814|NCT01973036|"~     Multicenter randomized clinical trial comparing oxytocin versus oxytocin and foley catheter~     for induction in women who present with premature rupture of membranes who are not in labor.~   "
121815|NCT01973023|"~     Chronic stroke patients exhibit gait pattern alterations which are mainly due to spasticity~     and treated with repetitive multifocal botulinum toxin injection(BTI). Several studies~     demonstrated that single BTI-session in a single muscle of paretic lower limb(LL) improved~     kinematic gait parameters(GP) but surprisingly none of them assessed the effects of~     repetitive multifocal BTI on patient's gait pattern and their duration.~      The aim was to evaluate the impact of repetitive multifocal BTI-sessions on GP of chronic~     stroke patients. To that end, gait of patients has been compared using 3D-gait analysis after~     at least 2 consecutive BTI sessions.~   "
121816|NCT01973010|"~     The purpose of this study is to determine whether massage is effective in the treatment of~     low back pain and to optimize clinical therapeutic schedule of massage for low back pain.~   "
121817|NCT01972997|"~     This is a study investigating the effect of various SENSIMED Triggerfish sensor lens sizes on~     the recorded IOP related patterns in 10 healthy volunteers. Each volunteers receives 4~     24-hours sessions of pattern recording on one selected eye (study eye). Each of the sensor~     lens sizes is placed on the eye in the different sessions. Subjects visit the study site for~     installation and removal of the device and accompanying exams, but remain ambulatory during~     the recording.~   "
121818|NCT01972984|"~     1. Women with operable breast cancer with a 2-8 week preoperative waiting period will~          accept preoperative therapy trials and specifically taking a standard drug for breast~          cancer such as anastrozole in this study~        2. Short term anastrozole treatment will induce measurable changes in biomarker levels (ER,~          PR, Her2, Ki67) within the tumor.~        3. Degree of response to short term anastrozole varies with a) duration of treatment and b)~          breast cancer subtype (based on initial pre-treatment biomarker status)~   "
121819|NCT01972971|"~     Warfarin, the major oral anticoagulant currently available in Taiwan, is used for the~     prevention and treatment of a variety of thromboembolic disorders. Under dosing of warfarin~     may cause treatment failure and over dosing may cause bleeding because of its narrow~     therapeutic index. Therefore, it is important to monitor prothrombin time (PT) and~     international normalize ratio (INR) periodically in order to evaluate the appropriateness of~     warfarin dosing.~      Lots of factors influencing warfarin anticoagulation effects include polymorphisms of~     Cytochrome P450 2C9(CYP2C9)and Vitamin K epoxide reductase complex subunit 1(VKORC1)genes,~     age, weight, diet and concurrent medications. Taking into consideration of physicians' work~     load, pharmacist-managed anticoagulation clinics were set up to help strengthen patient care~     in US to ensure patient medication safety. In addition, differences in genetic polymorphisms~     between Chinese and Caucasian have great impacts on warfarin dosage, and there is still no~     consensus on warfarin utilization guideline in Taiwan. Pharmacist-managed anticoagulation~     clinics provide individualized care, consistent monitoring and patient education. Through~     this service, physicians can get the latest integrated information about their patients,~     patients themselves are more familiar with their medication, and adherence can be improved.~     Therefore, those who take warfarin will get better INR control, less adverse drug-related~     events and treatment failure.~      This is the first prototype of pharmacist clinic for a specific medication in our hospital.~     The adverse drug events and coagulation function data collected through this program can be~     used for the implementation of warfarin treatment guideline in Taiwan in the future. The~     impact of pharmacist clinic can be evaluated by questionnaire of satisfaction and knowledge~     survey. It can be used as a model for implementing other pharmacist-managed clinics and~     improving patient medication safety.~   "
121820|NCT01972958|"~     As the aging population increases, preventing and decreasing disabilities become a critical~     issue for the health care system. Previous researches have shown that preventive~     community-based nursing services for older adults could achieve important health benefits at~     a relatively low cost. However, many frail and pre-frail older adults living in communities~     cannot get enough attention from current health care system. The role and function of nurses~     should be expanded to provide more comprehensive family-oriented care to improve health~     outcomes of older adults in Taiwan. The objectives of this study are:~        1. Understand the difficulties and solutions for nurses providing community-based services~          in order to expand their better role and function.~        2. Develop a cultural sensitive community advanced nurse service model for Taiwan in health~          care system.~        3. Explore the effectiveness of community health programs by nurses for frail or pre-frail~          older adults in community.~      Focus groups and literature review will be used to achieve the first and second study~     objectives. A single centre randomized controlled trial will be used in this study to achieve~     the third study objective. Two hundred and twenty people aged 65 and over who meet the Fried~     definition of frailty and pre-frailty will be recruited from the clinic of a hospital.~     Participants will be followed for a 6-month period. Frailty, quality of life, satisfaction to~     the services, hospitalizations and admissions to nursing care facilities will be measured and~     compared between experimental group and control group. This research is an important step in~     the examination of a new approach to the community older people by nurses. The study results~     will provide the evidence data to recommendation for related policy making in the future.~   "
121835|NCT01972763|"~     The purpose of the study is to determine the effectiveness of Ranibizumab 0.5 mg or 1.0 mg in~     subjects who were previously treated with Bevacizumab and subsequently switched to~     Aflibercept. These subjects have demonstrated a sub-optimal therapeutic response to the~     previous therapies; therefore, the study aims to see if Ranibizumab may have a greater~     treatment effect.~   "
121821|NCT01972945|"~     Inserting a telescope into the womb to identify and treat problems with bleeding, pain or~     reproduction is the commonest surgical intervention in gynaecology. This procedure is known~     as a 'hysteroscopy'. The established 'traditional' technique for introducing the hysteroscope~     into the womb involves the use of a 'speculum', which is inserted into the vagina. A speculum~     is the metal or plastic instrument used to stretch and separate the vaginal walls so that the~     opening to the womb, known as the 'cervix' can be seen. The cervix is then cleaned and~     frequently grasped with a sharp toothed forcep to provide traction before the hysteroscope is~     inserted. Whilst hysteroscopy is safe, it is known that pain during the procedure can lead to~     a poor patient experience, and even trigger fainting episodes or failure to complete the~     procedure. As the hysteroscopes have become smaller, it has been recognised that it is~     possible to access the cervix and womb (i.e. 'uterus') directly using the hysteroscopic~     vision without inserting any of these potentially pain inducing vaginal instruments. There is~     however, uncertainty whether this newer technique known as 'vaginoscopy' or the 'no touch~     technique' will minimise the pain experienced by the patient or reduce the propensity to~     fainting. Futhermore, even if vaginoscopy is shown to be less painful, the technique may be~     more prone to failure due to an inability to transverse the cervix and enter the uterus~     without additional instruments. Post-operative infection rates of the uterus may also be~     higher due to vaginal contamination.~      Reducing pain and complications and improving success of the procedure as well as optimising~     patients experience is important because hysteroscopy is an intimate examination, known to be~     associated with significant anxiety and pain. Furthermore, the procedure is widely practised~     representing the most common surgical intervention in day-to-day gynaecological practice in~     the UK and elsewhere. It is therefore important, and timely given that outpatient~     hysteroscopy is increasing especially in community settings, that a large, high quality~     randomised controlled trial comparing 'vaginoscopy' and the 'traditional' hysteroscopy is~     undertaken to resolve the uncertainty as to whether vaginoscopy is less painful, safe and~     more successful than existing approaches to hysteroscopy.~   "
121822|NCT01972932|"~     Antibiotic-associated diarrhea (AAD) and particularly Clostridium difficile-Infection (CDI)~     are the most common causes of healthcare associated infectious diarrhea. In light of the~     results obtained in a limited number of randomized clinical trials in subjects with AAD and~     CDI in comparison with the widespread occurrence of these diseases, it is felt that the~     addition of a well-controlled clinical trial in a western environment would add value to~     support the use of a specific probiotic to counteract these diseases.~   "
121823|NCT01972919|"~     This research study is for people who have pancreas cancer for which surgery is not~     recommended. Potential patients must have already received several months of chemotherapy~     before they are eligible for this study and there will not have been any detectable spread of~     their tumor on imaging studies following this chemotherapy course.~   "
121824|NCT01972906|"~     Hypothesis: Moxibustion is effective for managing primary dysmenorrhea. Aim: To attest the~     effectiveness and safety of moxibustion for primary dysmenorrhea. Design: A randomized~     controlled trial. 152 participants will be included. Two arms: moxibustion treatment group~     and ibuprofen control group.~   "
121825|NCT01972893|"~     ZYD1 is a novel GLP-1 receptor agonist. The ZYD1 exhibits increased stability to proteolytic~     cleavage, especially against dipeptidyl peptidase-4 (DPP-IV).~      ZYD1 is a potent antidiabetic agent without gastrointestinal side-effects. A first in human~     (FIH) Phase I study intends to evaluate the safety, tolerability, pharmacokinetics and~     pharmacodynamics of ZYD1 in normal healthy adult volunteers.~   "
121826|NCT01972880|"~     To assess the bioequivalence of a single dose of ASP1941 between tablet-1 and tablet-2 in a~     two-way crossover method in non-elderly healthy male subjects. In addition, the safety of~     these products will be assessed.~   "
121827|NCT01972867|"~     The purpose of this study is to evaluate the feasibility and short-term safety and~     effectiveness of the NanoKnife™ System when used to ablate localized prostate cancer in low~     risk subjects with organ-confined prostate cancer and a low risk of recurrence. This study~     will evaluate the feasibility of the NanoKnife™ System as a focal therapy.~   "
121828|NCT01972854|"~     The objectives of this study are to evaluate the safety and efficacy of corneal collagen~     cross-linking performed with VibeX (riboflavin ophthalmic solution) and the KXL System as~     compared to placebo in impeding the progression of, and/or reducing, maximum corneal~     curvature.~   "
121829|NCT01972841|"~     The purpose of this study is to examine how well two medicines (solifenacin succinate and~     mirabegron) combined work compared to each medicine alone in the treatment of bladder~     problems.~   "
121830|NCT01972828|"~     Haemodynamic optimization is of paramount importance in septic shock, but is really~     consensual and standardized during the first 6 hours of treatment. Haemodynamic treatment~     including fluid loading management, vasoactive treatment and oxygen transport optimization is~     mainly based on expert recommendations or non-randomized trials. Recently, preload dependence~     indexes such as pulse pressure variation have been shown to be more accurate to predict fluid~     responsiveness than static indexes such as filling pressures. However, whether using preload~     dependence indexes changes septic shock prognostic remains to date unknown. The aim of this~     non-blinded randomized controlled trial is to assess whether haemodynamic optimization using~     preload dependence indexes and pulmonary thermodilution 1. reduces septic shock duration~     assessed by administration duration of vasoactive treatment (primary end point), 2. reduces~     regional hypoperfusion assessed by arterial lactate, 3. reduces lung hydrostatic oedema~     linked to excessive fluid loading (assessed by PaO2/FIO2 ratio and extravascular lung water).~     4. reduces organ dysfunction (assessed by the SOFA score), ICU stay and 7 and 28 day~     mortality Control group is managed with an algorithm using filling pressures to drive~     haemodynamic treatment.~   "
121831|NCT01972815|"~     Nasopharyngeal carcinoma (NPC) is a virus-associated cancer that is rare among Caucasians but~     occurs at an elevated rate among Southern Asians. Rates of NPC are particularly high among~     individuals with a family history of this disease, but no specific genetic factors have been~     identified that can serve to guide clinical management of this high-risk population to ensure~     early detection and treatment of this life-threatening condition.~   "
121832|NCT01972802|"~     Our overall objective is to understand the role of lifestyle factors, genetics and HPV~     infection in the development and prognosis of head and neck cancer particularly in Asia.~   "
121833|NCT01972789|"~     To evaluate and compare two individualised ranibizumab treatment regimens, differentiated by~     the definition of disease activity which determines the treatment interval until the next~     injection. The results will be used to generate further recommendations about intensive~     versus relaxed treatment approaches and how they can be utilised within an 'inject and~     extend' approach to maximise patient outcomes, while reducing the need for potentially~     unnecessary intravitreal injections. This study will also investigate genotypic expression~     and response to intravitreal injections of ranibizumab between the two treatment arms.~      The study hypothesis is that intravitreal ranibizumab when administered to resolve IRF only~     results in visual acuity benefit that is not clinically worse than intravitreal ranibizumab~     when administered to completely resolve both IRF and SRF in patients with wet AMD.~   "
121840|NCT01972698|"~     The purpose of this study is to determine whether a self-directed and simulation-based lung~     ultrasound (LUS) and focused cardiac ultrasound (FCU) curriculum is efficacious on anesthesia~     trainees' image acquisition skills and diagnostic acumen. The investigators hypothesize that~     a self-directed and ultrasound-assisted LUS and FCU curriculum that includes video lectures,~     online teaching modules, an ultrasound simulator, and self-directed hands-on sessions on~     critically ill mechanically ventilated patients is effective in training novice~     ultrasonographers to obtain good quality images, to correctly interpret them, and to support~     clinical decision-making in critically ill patients.~      Trainees will be randomized to fully supervised FCU hands-on sessions on healthy models and~     critically ill mechanically ventilated patients (control group - traditional apprenticeship~     model) or to a completely self-directed and simulation-based approach (intervention group).~      To assess if this new self-directed and simulation-based ultrasound curriculum leads to~     adequate acquisition of competences (adequate image acquisition and interpretation) in novice~     ultrasonographers, trainees will have to perform a focused lung and cardiac assessment on a~     critically ill mechanically ventilated patient.~   "
121841|NCT01972685|"~     The objective of this study is to compare the sample size, architectural preservation and~     diagnostic yield of bronchoscopic cryo-probe transbronchial lung biopsy (C-TBBx) to~     bronchoscopic standard transbronchial lung biopsy (S-TBBx) and Video-Assisted Thoracoscopic~     Surgery (VATS) lung biopsy for the diagnosis of interstitial lung disease (ILD).~   "
121842|NCT01972672|"~     The primary objective of the study is to assess the time to progression (TTP) in patients~     with advanced HCC treated with Icaritin .~   "
121843|NCT01972659|"~     Background: The aim of this prospective study was to evaluate the effect of magnesium on the~     reversal of rocuronium-induced neuromuscular block by sugammadex.~      Methods: Eighty patients, aged 18 to 60 years, American Society of Anesthesiologists I-II,~     undergoing elective gynecological surgery were enrolled. Anaesthesia was induced with~     propofol and fentanyl and was maintained with 60% nitrous oxide and Oxygen in sevoflurane.~     The magnesium group received 50 milligram/kilogram (mg/kg) Magnesium intravenous (iv) as a~     bolus and 15 mg/kg/hour by continuous infusion until the completion of surgery. The placebo~     group received the equivalent volume of isotonic saline. For intubation, 0.6 mg/kg rocuronium~     was administered and 0.1 mg/kg was added when Train of four (TOF) counts reached 1 or more~     during the procedure. At the end of the surgery at a TOF count of 1, 4 mg/kg sugammadex iv~     was administered. Patients were observed until a TOF ratio of 0.9 was achieved.~     Patient-controlled analgesia with intravenous morphine was used postoperatively.~   "
121844|NCT01972646|"~     Introduction: Despite several expert panel recommendations and cellulitis treatment~     guidelines, there are currently no clinical decision rules to assist clinicians in deciding~     which emergency department (ED) patients should be treated with oral antibiotics and which~     patients require intravenous therapy at first presentation of uncomplicated cellulitis. The~     objective of this prospective study is to determine potential patient risk factors associated~     with adult patients (>17years) presenting to the ED with a concern about a skin or soft~     tissue infection who fail initial antibiotic therapy for the treatment of standard cellulitis~     and require a change of antibiotics or admission to hospital.~      Methods: This study will be a prospective study conducted in two tertiary care EDs. Patients~     will be excluded if they have been treated with antibiotics for the current bout of~     cellulitis prior to presenting to the ED, patients admitted to hospital and those patients~     with abscesses only. Hired research assistants (RAs) will administer a questionnaire at the~     initial ED visit with telephone follow-up 2 weeks later. Treatment failure will be defined as~     patients requiring subsequent hospitalization, initiation of intravenous antibiotics (if oral~     antibiotics were prescribed initially), or a change of oral antibiotics for the original~     cellulitis.~      Results: This study will provide a detailed profile of patient risk factors associated with~     treatment failure of cellulitis. The results will be analyzed and used in formulating a~     clinical decision rule for effective treatment of cellulitis presenting to the ED. Each of~     the predictor variables associated (p ≤ 0.1) with failed treatment in the univariate analysis~     will be considered in a multivariate logistic regression model. Additionally, treatment~     variability among clinicians in regard to cellulitis will be evaluated and compared to~     treatment failures, thus providing data on successful treatment regimens.~      Conclusions: Results from this research may be used to generate a clinical prediction rule to~     assist clinicians in effectively treating patients presenting to emergency departments with~     cellulitis. Understanding which patient risk factors for treatment failure will assist~     clinicians in determining which patients will benefit from intravenous versus oral~     antibiotics.~   "
121845|NCT01972633|"~     There is a difference concerning obliteration rate and postoperative pain after treatment of~     the saphenous vein with 1470nm laser or VNUS Closure Fast (=radiofrequency method) .~   "
121846|NCT01972620|"~     Analgesic efficacy of multi-modal analgesia is superior to standard analgesia for patients~     undergoing elective laparoscopic cholecystectomy for symptomatic cholelithiasis. Topical~     cystic plate and port-site incision 0.25% bupivacaine significantly reduces pain after~     laparoscopic cholecystectomy.~   "
121847|NCT01972607|"~     This study has been designed in order to know the effect of 12 weeks of aerobic exercise~     training for migraine prevention. We hypothesized that the exercise training could reduce the~     number of days with migraine and the number of attacks per month in the treated group.~   "
121848|NCT01972594|"~     Total hip replacement is designed to alleviate pain, reduce disability and improve function~     and physical activity levels. Whilst pain, disability and function are often measured~     following surgery, actual physical activity is not. The aim of rehabilitation after total hip~     replacement would be to obtain optimal strength and range of movement at the hip along with~     cumulative endurance and balance. It is taken for granted that, once function is restored,~     the patient returns to physical activity levels associated with good health. In a previous~     study conducted by the same team it was observed that patients, at the end of 3 months after~     hip surgery, do not reach the levels of physical activity which are proven to be beneficial~     for health. Physiotherapy plays an important role in improving function and increasing levels~     of Physical activity in total hip replacement patients, but there is limited literature to~     substantiate this claim. There is a need to enhance levels of physical activity in patient~     after total hip replacement towards levels that are associated with good health. This study~     aims to demonstrate a method of enhancing physical activity levels after total hip~     replacement using a pedometer based intervention over a period of 3 months. Patients will~     follow a customized progressive stepping activity schedule aimed at establishing levels of~     physical activity that are associated with good health. To fully understand recovery patterns~     subjective and objective measures of strength of the hip muscles, range of motion at the hip,~     overall endurance, balance and speed of walking of the patient will be assessed.~     Questionnaires will be utilized to assess quality of life both before and after total hip~     surgery. The physical activity levels of the patient will be measured with a physical~     activity monitor. This study will be completed at the Golden Jubilee National Hospital at~     Glasgow.~   "
121849|NCT01972581|"~     Incorporating neurocognitive visual reaction training has been shown to increase bating~     performance in collegiate baseball players. However, poor methodology, such as lack of a~     control group and use of an unreliable outcome measure, limit the strength of the previous~     study. Therefore the purpose of this study is to determine the effects of neurocognitive~     visual reaction training on reaction time and coordination in an athletic population.~      The purpose of this study is to determine the effects of neurocognitive visual reaction~     training on reaction time and coordination.~   "
121850|NCT01972568|"~     This is a multi-center, double-blind, randomized, Phase 2b trial to evaluate the efficacy of~     atacicept in subjects with systemic lupus erythematosus (SLE).~   "
121851|NCT01972555|"~     This is a single-center, open-label, randomized controlled trial. Patients scheduled for~     aortic valve replacement (AVR) at Karolinska University Hospital in Stockholm, Sweden will be~     eligible. Forty patients will be randomly assigned to either minimally invasive (20 patients)~     or conventional AVR (20 patients). CE-marked and FDA-approved mechanical and bioprosthetic~     aortic valves (conventional stented or sutureless bioprostheses) will be implanted.~     Transthoracic echocardiography will be performed before surgery, and at day 1, 4, and 40.~     Echocardiographic parameters as well as preoperative clinical characteristics and~     postoperative clinical outcomes will be registered. Routine blood sampling will be performed~     pre- and postoperatively. All available data will be collected prospectively. Informed~     consent will be obtained from patients meeting the inclusion criteria before the initiation~     of any study-specific procedures.~   "
121852|NCT01972542|"~     The hypertriglyceridemia at fasting status has been known to be an important risk factor for~     cardiovascular disease (CVD). Recently, postprandial triglyceride (TG) levels draw an~     attention as a superior predictor of CVD because of non-fasting state for more than 12 hours~     and importance of triglyceride-rich lipoprotein.~      We aim to investigate the relationship of postprandial triglyceride after fat tolerance test~     and intima-medial thickness and to suggest normal reference of postprandial triglyceride~     after fat tolerance test. In addition, we evaluate the correlation of postprandial~     triglyceride and incretin secretion after fat tolerance test Ultimately, we want to estimate~     clinical importance of postprandial triglyceride in assessment of cardiovascular risk.~   "
121853|NCT01972529|"~     This is a global, multicenter, randomized, double-blind, placebo-controlled, parallel group~     study using avatrombopag to treat adults with thrombocytopenia associated with liver disease.~     The study will evaluate avatrombopag in the treatment of thrombocytopenia associated with~     liver disease prior to an elective procedure to reduce the need for platelet transfusions or~     any rescue procedure for bleeding due to procedural and post-procedural bleeding~     complications. Participants will be enrolled into 2 cohorts according to mean baseline~     platelet count and, within each baseline platelet count cohort will be further stratified by~     risk of bleeding associated with the elective procedure (low, moderate, or high) and~     hepatocellular carcinoma (HCC) status (Yes or No).~   "
121854|NCT01972516|"~     This research study is evaluating a drug called tivozanib as a possible treatment for~     ovarian, fallopian tube or primary peritoneal cancer.~      Angiogenesis is the formation of new blood vessels. Tumors need blood vessels to grow and~     spread. Tivozanib is an anti-angiogenesis medicine that fights cancer by cutting off a~     tumor's blood supply so that it does not get the blood and nutrients it needs to grow.~      In this research study, the Investigators are looking to see whether tivozanib works as a~     maintenance therapy for ovarian, fallopian tube or primary peritoneal carcinoma in~     participants who have achieved a complete response following chemotherapy. Maintenance~     therapy is given after a disease has responded to previous treatment. It is given to help~     prevent the spread or recurrence of the tumor.~   "
121855|NCT01972503|"~     In this study, the investigators assessed whether intraoperative Intraportal infusion of 5-FU~     and oxaliplatin is able to prevent liver metastasis in patients receiving curative colorectal~     cancer resection.~   "
121856|NCT01972490|"~     In this study, the investigators assessed the effect of avastin in combination with~     chemotherapy in the treatment of unresectable metastatic colorectal cancer.~   "
121857|NCT01972477|"~     This is a parallel, 3-arm, randomized, prospective, placebo-controlled, and double-blind~     clinical study for eight weeks of therapy to investigate the clinical efficacy of DLBS1449 in~     elevating high density lipoprotein (HDL) cholesterol in diabetic patients. The hypothesis of~     interest for the study is: the administration of DLBS1449 will elevate HDL-cholesterol level~     from baseline to the end of study significantly higher than the elevation resulted by~     placebo. In addition, the administration of DLBS1449 at the dose of 150 mg daily will provide~     a significantly better response than that of the lower dose (DLBS1449 75 mg daily).~   "
121858|NCT01972464|"~     Smoking is the main preventable cause of mortality in Western countries, contributing to over~     430,000 deaths a year in the U.S. alone. Clinical and epidemiological studies show that women~     often decrease smoking in pregnancy, when progesterone levels are high. However, at least~     half resume pre-pregnancy smoking levels within weeks after delivery and when progesterone~     levels drop.~      Data from preclinical and clinical studies suggest that progesterone may be effective in~     preventing relapse to smoking in non-postpartum women. Prior work has shown that progesterone~     decreases both craving for cigarettes and the subjective rewarding effects of smoking among~     recently abstinent female smokers. These findings led us to hypothesize that progesterone may~     have efficacy as a relapse prevention treatment for postpartum women.~      We propose an 8-week, randomized pilot study to evaluate the safety and initial efficacy of~     progesterone. This will be a feasibility study that will compare progesterone to placebo for~     relapse prevention in 40 postpartum smokers. We will assess the feasibility and safety,~     including the potential effects on breastfeeding and infants exposed via breast milk, in~     addition to 7-day point prevalence of smoking abstinence after 8 weeks of treatment and at~     follow-up, 3-months after the end of the protocol.~   "
121868|NCT01972334|"~     The incidence of C. difficile infection (CDI) has alarmingly increased over the past several~     years and the affected population has expanded to include those previously at low risk, such~     as children. The annual US financial burden associated with this infection is great and~     estimated to exceed $1.8 billion. C. difficile infection arises when the gut microbial~     ecology is disrupted during interventions notorious for perturbing the delicate microbial~     balance. A well known and common example is the use of antibiotics. Fecal microbiota~     transplant (FMT) has been introduced several decades ago in an attempt to restore the gut~     microbial balance. To this date there have been a great number of reports of success in~     eliminating recurrent C. difficile infections and restoring the gut microbial profile to~     resemble that of the healthy donor. While over 300 cases have been described in the~     literature, there has been no pediatric controlled studies performed to compare its efficacy~     to placebo. Therefore, there is a strong need to determine their safety and efficacy in~     pediatric randomized controlled studies. The investigators hypothesize that children with~     recurrent C. difficile infection will respond to fecal transplant therapy which will modify~     their gut microbial profile. The investigators propose a randomized, placebo controlled,~     pilot study of fecal microbial transplant in children with recurrent C. difficile infection~     to evaluate the safety and efficacy of fecal microbial transplant in children in preventing~     recurrent C. difficile infection. The investigators anticipate that fecal microbial~     transplant in children with recurrent C. difficile infection will be safe and efficacious and~     will provide these children with a great alternative to a disease that is difficult to treat.~     Results of this study will establish the major role of the gut microbiome in this disease and~     demonstrate the viability of gut microbial transplant in recipients.~   "
121869|NCT01972321|"~     The aim of the inSCALE project is to test the effect of innovative approaches to increase~     coverage of integrated community case management, which provides community based-care for~     diarrhoea, pneumonia and malaria, resulting in more children receiving timely and appropriate~     care for these three most common childhood illnesses~   "
121859|NCT01972451|"~     The Bowel Cancer Screening program was implemented to address the important issue of~     prevention and early detection of bowel cancer. Results from the first few years of screening~     and previous smaller studies show that while in its current form it will save many lives,~     there continue to be polyps and cancers in the upper large bowel (right side) that may be~     difficult to detect. There is some evidence that these types of polyps (serrated polyps) may~     be at least partly responsible for cancers missed at the initial colonoscopy and have a~     faster rate of growth to cancer compared to conventional polyps (adenomas). We propose to~     examine participants undergoing screening colonoscopy with the addition of a contrast dye ( a~     safe food colouring agent base already used in various bowel camera procedures in standard~     clinical practice). This has been shown to improve detection of conventional polyps~     significantly even though it is considered by some to be more time consuming (possibly taking~     a few minutes longer) and requiring specific training to undertake. We hope to study the~     feasibility of undertaking these procedures to improve detection and removal of these polyps~     within the bowel screening program and potentially inform further studies to assess the~     impact of improved detection and consequent potentially reduced incidence of interval or~     missed bowel cancers in longer term follow up. Thus the main aims of this feasibility study~     are to assess if this type of procedure would be feasible to implement and acceptable to~     participants, colonoscopists and the screening program and also assess any additional time or~     costs involved to inform the question of if a larger study should then be undertaken to~     conclusively prove or disprove the merits of this approach in terms of health economics,~     cancer detection and survival.~   "
121860|NCT01972438|"~     Some eye diseases can be helped by eye drops made from a person's own blood. These eye drops~     are called autologous serum eye drops, or ASEDs. ASEDs have been studied in only a few people~     with graft vs. host disease (GVHD) affecting the eye and were found to be helpful with few~     side effects.~      The purpose of this study was to determine whether ASEDs are safe and more effective than~     control (normal saline) and can help with eye symptoms in people with severe chronic eye~     GVHD.~      Each participant in this study was to have blood drawn to prepare ASEDs specifically for the~     participant. Each participant was scheduled to receive ASEDs for 3 months and placebo eye~     drops (salt water) for 3 months. Participants did not know when they were receiving the ASEDs~     and when they were receiving placebo eye drops.~   "
121861|NCT01972425|"~     Critically ill patients whose lungs are supported by breathing machines (ventilators)~     commonly develop a new lung infection, called ventilator-associated pneumonia (VAP). Because~     VAP is often fatal, antibiotics are administered whenever it is suspected. However VAP is~     hard to distinguish from several non-infective lung conditions and most patients with~     suspected VAP do not have pneumonia. Therefore many patients receive unnecessary antibiotics~     for several days, promoting emergence of 'superbugs'. Laboratory test results for diagnosing~     VAP typically only reach the doctors after 3 days.~      A simple test rapidly and confidently excluding VAP should improve patient care, reduce~     unnecessary antibiotics and decrease costs. We recently showed that low levels of specific~     proteins in fluid from the lungs of patients with suspected VAP effectively excluded VAP,~     using a test that may yield results within 6 hours. The test used is an extension of existing~     technology produced by our commercial partner Becton Dickinson (BD) Biosciences.~      Our previous findings were derived from a single hospital's intensive care unit. We have~     recently confirmed this finding across many intensive care units, which will help show that~     the test can be used in 'real life'. The aim of this study is to take the new test to the~     next step and determine whether it can improve the care of patients by reducing the amount of~     unnecessary antibiotics prescribed. This will be done using a 'randomised controlled trial',~     the best tool for scientifically testing a new diagnostic test. To do this we shall identify~     patients with suspected VAP, all of whom will have a lung sample - half of the patients will~     receive 'usual care' for suspected VAP, the other half will have the new test performed on~     their lung fluid. If the new test suggests no lung infection, the doctors will be asked to~     consider not giving antibiotics. We shall test how much antibiotic is given to each group.~   "
121862|NCT01972412|"~     The purpose of this study is to determine whether phone use contributes to diabetes control.~   "
121863|NCT01972399|"~     The primary objective of this study is to compare the clinical outcomes of using Er: YAG~     laser along with bone graft and barrier membrane to conventional mechanical debridement also~     with bone graft and barrier membrane in the treatment of peri-implantitis infections.~   "
121864|NCT01972386|"~     To evaluate the clinical benefit of spectrum analysis of endobronchial ultrasound images of~     lymph nodes during EBUS TBNA for lymph node staging in patients with lung cancer.~   "
121865|NCT01972373|"~     To improve rectal cancer management, there is a need for better visualization of drug targets~     in rectal cancer to identify patients who might benefit from specific targeted treatments.~     Molecular imaging of rectal cancer associated targets is a promising technique to accommodate~     this need. Vascular Endothelial Growth Factor (VEGF), which is differentially expressed in~     normal versus malignant colon tissue, has proven to be a valid target for molecular imaging.~     Fluorescent labeling of bevacizumab (a VEGF targeting humanized monoclonal antibody currently~     used in anti-cancer therapy) using IRDye800CW (a fluorescent dye) has potential advantages in~     view of safety, infrastructure, costs, stability and imaging resolution. Therefore, the~     fluorescent tracer bevacizumab-IRDye800CW has been developed at the University Medical Center~     Groningen (UMCG) and was recently approved to be administered to patients in a tracer dose.~     To detect this tracer in vivo in patients with colorectal cancer, a newly developed flexible~     near-infrared (NIR) fluorescence endoscope and optoacoustic endoscope have been developed~     which can be used in clinical studies. Optical fluorescence imaging may support response~     evaluation following chemoradiotherapy and give insight which patient might benefit from~     anti-VEGF targeted therapy in future studies.~   "
121866|NCT01972360|"~     SPECT is currently the dominant clinical test for diagnostic and prognostic purposes as well~     as therapeutic decision-making. Given the shortage of nuclear reactor-produced Tc, advancing~     the use of non-isotope based imaging modalities has the potential to change the standard of~     care for patients with CAD as each one of these technics (CMR, CT, Stress echocardiography)~     has its own distinct potential advantages over SPECT.~   "
121867|NCT01972347|"~     This is an open label, single centre, phase II study of neoadjuvant drug treatment with~     dabrafenib + trametinib in patients with resectable American Joint Committee on Cancer (AJCC)~     Stage IIIB-C BRAF V600 mutation positive melanoma.~      The main aim of this study is to find out if giving of a new combined drug treatment to~     patients with melanoma that has spread to the lymph nodes BEFORE they have surgery, will~     result in improved clinical and pathological response of the melanoma tissue after 12 weeks~     treatment.~   "
122721|NCT01961167|"~     The primary objective of the GORE® PI-13-05 clinical study is to evaluate the safety and~     efficacy of PI 13-05 for the treatment of arterial occlusive disease in patients with de novo~     or restenotic lesions in the common and/or external iliac arteries.~   "
121870|NCT01972308|"~     Few interventions to improve asthma management have targeted low-income minority asthmatic~     adults and even fewer have focused on the real-world practice where care is provided for~     these patients. This project tests the effectiveness of a Patient Advocate as a practical and~     sustainable method of facilitating and maintaining communication between patient and provider~     and access to chronic care for adults with moderate or severe asthma recruited from clinics~     serving low-income urban neighborhoods. We compare the use of a Patient Advocate to current~     asthma care and test the Patient Advocate's cost-effectiveness.~   "
121871|NCT01972295|"~     This is an observational, prospective, non-randomized, multicenter study with the following~     objectives: (1) to compile real-world clinical outcomes data for WATCHMAN Left Atrial~     Appendage Closure Technology in patients who are implanted with the WATCHMAN device in a~     commercial clinical setting and (2) to collect health care usage data that may be needed for~     reimbursement of WATCHMAN technology in certain countries.~   "
121872|NCT01972282|"~     The WATCHMAN LAA Closure Technology is designed to prevent embolization of thrombi that may~     form in the LAA, thereby preventing the occurrence of ischemic stroke and systemic~     thromboembolism. The objectives of this observational, prospective, non-randomized~     multicenter study are (1) to compile real-world clinical outcomes data for WATCHMAN LAA (left~     atrial appendage) Close Technology in patients who are implanted with the WATCHMAN device in~     a commercial clinical setting and (2) to collect real-world usage data that may be needed for~     reimbursement of WATCHMAN technology in certain countries.~   "
121873|NCT01972269|"~     Different medications can be used as analgesics in labor epidurals. Bupivacaine is one of the~     most commonly used drugs for that purpose. The efficacy of a certain medication injected~     epidurally depends on the dose that is given. A certain dose can be administered in different~     concentrations, which will consequently mean different volumes. Studies have been done to~     determine volumes for different concentrations of bupivacaine. However, those studies fall~     short in the sense that this information cannot be readily applicable in clinical practice,~     as we don't use bupivacaine plain. The combination of bupivacaine and fentanyl or sufentanil~     is common practice, as it is well established that the opioids will reduce the concentration~     of local anesthetic required to produce optimal effect with the least side effects.~      This study is being planned to determine and compare the EV90 of the bupivacaine~     0.125%-fentanyl mixture for initiation of labor epidural analgesia, following the~     administration of the 2 different test doses (3cc of lidocaine 2% or 3cc of the bupivacaine~     0.125%-fentanyl mixture) used in our Department.~   "
121874|NCT01972256|"~     The purpose of this study is to demonstrate the relative efficacy of two lumbar fusion~     procedures: transacral lumbar interbody fusion when used in conjunction with unilateral or~     bilateral posterior pedicle screw fixation as an adjunct to fusion, in comparison to~     transforaminal lumbar interbody fusion (TLIF) when used in conjunction with unilateral or~     bilateral supplemental screw fixation as an adjunct to fusion.~      Subject candidates are those who had previously required and received fusion at L4-L5-S1~     where these were the only lumbar levels treated for pseudoarthrosis, spinal stenosis,~     spondylolisthesis, or degenerative disc disease (DDD).~   "
121875|NCT01972243|"~     Because of a high recurrence risk after unprovoked venous thromboembolism (VTE) indefinite~     anticoagulation is recommended, but confers a considerable bleeding risk. It is important to~     identify patients, in whom the recurrence risk is lower than the expected bleeding risk, and~     who will not benefit from long term anticoagulation. By use of a scoring model (Vienna~     Prediction Model), patients can be stratified according to their recurrence risk based on~     their sex, location of VTE and D-Dimer. Before implementation in routine care, an independent~     validation is required. Patients with unprovoked VTE will stop anticoagulation after 3-7~     months and the recurrence risk will be estimated by use of the Vienna Prediction Model. Low~     risk patients with a score of <180 will be included and will be left untreated. Patients with~     a high score will not be included and their management will follow current guidelines.~     Follow-up will be two years and the endpoint will be recurrent symptomatic VTE.~   "
121876|NCT01972230|"~     This study aimed to evaluate the possible protective effect of anesthetic technique balanced~     (BAL) compared to total intravenous anesthetic technique (TIVA-TCI) in ischemia reperfusion~     injury in microvascular flap in plastic surgery. The investigators will evaluate the~     viability of the flap using tissue oximetry monitoring and the level of biochemical markers~     in a circle at the end of the intervention.~   "
121877|NCT01972217|"~     This is a 2-part study in patients with metastatic CRPC. Part A is an open-label safety~     run-in study to assess the safety, tolerability and pharmacokinetics (PK) of olaparib when~     given in addition to abiraterone 1000 mg once daily. Part B is a randomised, double-blind,~     placebo controlled comparison of the efficacy, safety and tolerability of the dose of~     olaparib selected from Part A when given in addition to abiraterone, versus placebo given in~     addition to abiraterone. Abiraterone is indicated in combination with prednisone or~     prednisolone for the treatment of patients with metastatic CRPC. Prednisone or prednisolone 5~     mg twice daily (bid) will be administered with the abiraterone in this study.~   "
121878|NCT01972204|"~     The purpose of this study is to examine the influence of the instruction on the use of~     Aricept with educational brochure on the 48-week medication persistence and to assess the~     reasons for discontinuation.~   "
121879|NCT01972191|"~     Before astigmatism reducing surgery, accurate corneal horizontal marking before surgery is~     important. Due to new corneal topographic method, iTrace™ surgical workstation, precise~     evaluation of corneal horizontal marking is available. In this study the investigators~     compared three known corneal horizontal making techniques and evaluate accuracy of each~     methods using iTrace™.~   "
121880|NCT01972178|"~     The objective of this study is~        -  To evaluate the efficacy of PRC-4016 by assessment of the percentage change in blood~          lipids and lipoprotein parameter from baseline after 12 weeks of treatment~        -  To evaluate the safety of PRC-4016 as assessed by adverse events and other safety~          parameters~   "
122065|NCT01969747|"~     Placebo-controlled, double blind (triple-dummy technique), randomised parallel design~     comparison of three oral doses (2.5 mg, 10 mg, and 25 mg) of empagliflozin in patients with~     T1DM as adjunctive therapy to insulin over 28 days. Patients will undergo a 14-day open-label~     placebo run-in period before randomisation. Background insulin therapy will be kept stable~     during the first 7 days of the treatment period and will be freely adjusted thereafter.~   "
121881|NCT01972165|"~     A few studies have shown that the mini-incision release technique decreases the pathologic~     swelling of the median nerve at the inlet of the carpal tunnel and increases the flattening~     ratio of the median nerve in the carpal tunnel. However, it is unknown whether the endoscopic~     release technique similarly reverses these pathological changes in the median nerve along the~     carpal tunnel in patients with CTS compared with the mini-incision release.~      Investigators therefore conducted the current study to compare the subjective outcomes and~     US-measured morphological changes in the median nerve in patients with CTS who received~     either mini-incision or endoscopic release. Investigators hypothesized that (1) subjective~     outcomes, as assessed by both the Boston Carpal Tunnel Questionnaire (BCTQ) symptom/function~     scores and the DASH scores, would be similar 24 weeks after either mini-incision or~     endoscopic carpal tunnel release; (2) changes in the morphology of the median nerve at each~     level of the carpal tunnel, as measured under high-resolution US, would be similar 24 weeks~     after either mini-incision or endoscopic carpal tunnel release; and (3) morphological changes~     would be correlated with improvements in subjective outcomes 24 weeks after mini-incision or~     endoscopic carpal tunnel release.~   "
121882|NCT01972152|"~     The purpose of this study is to demonstrate that G-Pen(TM) glucagon is comparable to Lilly~     Glucagon(TM) in terms of safety and efficacy, as a treatment for severe hypoglycemia, a~     complication of diabetes.~   "
121883|NCT01972139|"~     An international, multi-center, prospective, blinded, randomized, controlled trial. The~     objective is to demonstrate that catheter-based renal denervation is an effective and safe~     treatment for uncontrolled hypertension.~   "
121884|NCT01972126|"~     The MAGNetic QRS-Fragmentation in Patients with Myocardial InfarcTion and Moderately RedUceD~     Ejection Fraction (MAGNITUDE) study will assess in MI survivors with moderately reduced left~     ventricular function, whether non-invasive MFI QRS Fragmentation alone or in combination with~     parameters derived from a Holter recording can be used to identify a group of patients at~     high risk for SCD/life threatening ventricular arrhythmia.~   "
121885|NCT01972113|"~     The undercarboxylated fractions of the two vitamin K-dependent proteins osteocalcin and~     matrix Gla protein have been shown to play key roles in type 2 diabetes and cardiovascular~     disease (at least in mouse models). Clinical trials are needed to isolate the effects of~     vitamin K manipulation on carboxylation of these two proteins (osteocalcin and matrix GLA~     protein) and their subsequent effects on markers of diabetes and cardiovascular disease risk.~     The purpose of this pilot randomized, double-blind, placebo-controlled trial in children is~     to estimate the effective dose of vitamin K2 (menaquinone-7) supplementation (to improve~     carboxylation of both osteocalcin and matrix Gla protein), and whether it can have an effect~     on markers associated with diabetes and cardiovascular disease risk.~   "
121886|NCT01972100|"~     The study hypothesis is a improved muscle fatigue resistance induced by low-level laser~     therapy applied between sets of intense exercises.~   "
121887|NCT01972087|"~     This study is to test the use of simulation training to improve 9-1-1 telecommunicators' call~     processing and response. Training sessions will expose 9-1-1 telecommunicators to several~     realistic emergency situations through mock 9-1-1 calls with a trained actor playing the part~     of a reporting party, followed immediately by feedback on call handling provided by a trained~     call observer. Investigators hypothesize that simulation followed by trained~     observer-directed feedback will increase correct triage of medical emergency and delivery of~     pre-arrival instructions during simulated calls and in actual 9-1-1 calls.~   "
121888|NCT01972074|"~     This study is a 12-week randomized-controlled trial of memantine hydrochloride (Namenda) for~     the treatment for social impairment in adolescents with autism spectrum disorder (ASD). The~     investigators will also conduct pre- and post-treatment neuroimaging (fMRI and HMRS) to~     assess neural functional deficits in adolescents with ASD compared to healthy volunteer~     adolescents and to assess any effects of memantine therapy on neural function in adolescents~     with ASD. The investigators hypothesize that short-term memantine monotherapy will be safe,~     well-tolerated, and effective in improving the core symptoms of autism spectrum disorder in~     adolescents with ASD. Additionally, the investigators hypothesize that following memantine~     therapy, ASD subjects will exhibit a decrease in glutamate (Glu) concentration in the~     anterior-cingulate cortex (ACC) and a change towards normalization in altered functional~     connectivity of the ACC and medial temporal lobes, consistent with improvement in social~     impairments in ASD. The investigators hypothesize that compared to healthy volunteer~     subjects, ASD subjects will significantly differ on neuroimaging measures at baseline but~     that following memantine therapy, the difference between ASD and healthy volunteer~     neuroimaging data will decrease.~   "
121889|NCT01972061|"~     The purpose of this study is to determine if electrical stimulation of the foot is effective~     in the treatment of overactive bladder conditions.~   "
121890|NCT01972048|"~     Korean American (KA) women have among the highest breast cancer mortality rates and lowest~     breast cancer screening rates of U.S. American women across racial/ethical groups. This~     innovative project seeks to harness mobile phone technology as a means to take preventative~     health care to a new level among this population. Using the Fogg Behavioral Model this study~     proposes to develop a mobile phone-based intervention designed to motivate KA women to~     undergo an annual mammogram (mMammogram). The overall study aim is to develop and assess the~     feasibility and effectiveness of a 7-day long mMammogram intervention designed to persuade KA~     women to undergo breast cancer screening.~   "
121891|NCT01972035|"~     Our study will compare all kidney transplant recipients receiving valganciclovir vs.~     valacyclovir for one year following kidney transplant and compare:~        1. the incidence, magnitude and duration of CMV and EBV viremia in the first year after~          transplant.~        2. the side effects of the anti-viral drugs requiring dose reduction or cessation~      In addition, we will test renal tissue obtained from any biopsies post-transplant~     (surveillance or clinically indicated biopsies) by both polymerase chain reaction (PCR) and~     fluorescence in situ hybridization to assess for latent CMV and/or EBV.~   "
121892|NCT01972022|"~     First prospective randomized controlled study to evaluate in an 'all-comers' population with~     coronary artery disease whether treatment with a novel everolimus eluting stent (EES) with a~     biodegradable polymer is superior to a durable polymer zotarolimus eluting stent (ZES), with~     respect to the long term vascular response to treatment These data are important to ascertain~     the superiority of a new generation DES with bioabsorbable polymer coating to reduce the long~     term development of in-stent neoatherosclerosis.~   "
121893|NCT01972009|"~     The mechanism governing how blood flows from the heart to the lungs depends on many factors~     including the pumping function of the right ventricle, properties of the arteries that carry~     the blood from the right ventricle to the lungs (pulmonary arteries), and the lungs~     themselves.~      Under normal conditions the pressure in the pulmonary arteries is well controlled and~     significantly lower than in the systemic circulation, however there are a number of~     conditions that lead to abnormally high pressures and significant morbidity and mortality.~      However different patients respond differently to similarly elevated pressures, leading~     doctors to believe that there must be differences in either the right ventricles, the~     properties of the arteries, or the lungs themselves. It can be difficult to determine the~     relative contributions of each of these factors on blood flow because their effects are~     superimposed on each other.~      One approach that has been used to look at this in other parts of the circulation (including~     in the systemic circulation and the coronary arteries) is to measure simultaneous pressure~     and flow, and apply a technique called wave intensity analysis (WIA). This technique can~     amongst other things, quantify the separate effects of wave reflection and the 'reservoir~     function' (or compliance) of the arteries, and in the systemic circulation WIA has increased~     the understanding of the mechanisms behind hypertension and the physiological changes of~     ageing. The pulmonary arteries are accepted to be very different from the systemic~     circulation and the mechanisms behind pulmonary hypertension are thought to be very different~     to those of systemic hypertension.~      This protocol aims to determine the major influences on blood flow in the pulmonary arteries~     in health and disease, to help to understand why some patients are affected more than others~     by elevated pulmonary pressures.~   "
121894|NCT01971996|"~     During general anaesthesia, to ensure sufficient oxygen supply to the brain, the NIRS~     technology can be used. It consist of two sensors placed on the forehead, and measures the~     oxygen saturation of the tissue underneath the sensor. For patients undergoing back surgery~     placed in the prone position, the NIRS measurement will be affected, because the weight of~     the head will produce a pressure on the sensors. We wish to investigate how much the~     measurement is affected. Furthermore we plan to lift the head to remove the pressure, and~     record the time needed for the measurements to return to baseline.~   "
121895|NCT01971983|"~     The objective of this randomized controlled trial is to describe the effect of two~     osteopathic techniques - high velocity, low amplitude (HVLA) and muscle energy (ME) - on~     thickness, activation, strength, pressure pain threshold (PPT) of the paravertebral muscles~     at the lumbar spine, as well as the peak plantar pressures immediately and after a two-day~     follow-up.~      The muscle thickness of the paravertebral muscles at the lumbar spine, namely internal~     oblique, external oblique and transversus abdominis can be altered after the application of~     'high-velocity low-amplitude'(HVLA)and 'muscle energy' (ME)techniques immediately and after a~     two-day follow-up.~   "
121896|NCT01971970|"~     Anti-TNF treatment (infliximab (IFX), adalimumab (ADA)) has become standard therapy for~     refractory pediatric and adult Crohn's disease (CD) patients, and is used for the induction~     (primary response) and maintenance of remission. When effective, clinical and endoscopic~     remission is reached within weeks. However, primary non-response is observed in 20% of~     pediatric patients, and in 40% of adult CD patients, suggesting a more robust acute response~     to anti-TNF therapy in children as compared to adults.During maintenance treatment, 60 - 80%~     of patients have secondary loss of response, necessitating dose adjustments to maintain~     clinical response. Anti-TNF treatment is also increasingly used in ulcerative colitis (UC),~     and has been shown to induce remission in active disease. For UC, the comparison between the~     efficacy in children versus adults is more difficult to report as studies in children are~     scarce. Anti-TNF treatment is associated with rare but potentially fatal side effects,~     infusion reactions, and is an expensive treatment. To avoid overtreatment it is necessary to~     early identify non-responders to treatment, and therefore it is important to develop~     predictive biomarkers of treatment response.~   "
121897|NCT01971957|"~     Sjogren-Larsson syndrome (SLS) is a rare genetic disease in which patients typically exhibit~     ichthyosis (dry, scaly skin), intellectual disability, spasticity, seizures and a distinctive~     maculopathy. The purpose of this study is to define the clinical spectrum and natural history~     of Sjogren-Larsson syndrome, and identify biomarkers that correlate with disease phenotype~     while establishing a registry for future investigations of biochemical pathogenesis and~     therapy.~   "
121898|NCT01971944|"~     Purpose: To compare the hemodynamic effects of dobutamine and milrinone in hospitalized~     patients who are receiving Beta Blocker Participants: Patients who are admitted to the~     General Cardiology and Heart Failure Services at the University of North Carolina Hospitals~     with acute decompensated heart failure, who have maintained steady state concentrations of~     beta blocker therapy (carvedilol or metoprolol), and who are deemed by the health care team~     to require pulmonary artery catheter placement and inotropic therapy with dobutamine or~     milrinone by continuous infusion. Patients that are not currently receiving beta blocker~     therapy will be enrolled for comparative purposes; however, any patient not at steady state~     (on or off beta blocker therapy) will not be enrolled.~      Procedures: After obtaining informed consent, patients will be assigned to the appropriate~     sub-study group based on beta blocker use (Study A: patients on stable doses of metoprolol~     and Study B: patients on stable doses of carvedilol). All patients should receive dobutamine~     followed by milrinone as outlined in the dosing algorithm (see inotrope dosing algorithm~     attached, as part of the usual standard of practice). Baseline pulmonary artery catheter~     hemodynamic parameters will be collected prior to administration of inotrope trial of~     dobutamine followed by milrinone. Hemodynamic parameters will be recorded per the dosing~     algorithm following initiation and dose titration. Dose titration will be determined by the~     health care team based upon patient response or lack thereof and tolerability. Changes in~     hemodynamic parameters in response to dobutamine or milrinone will be compared within study~     groups. Additionally, data will continue to be collected on patients receiving not beta~     blocker therapy for comparative purpose.~   "
121899|NCT01971931|"~     Bone quality is an important factor influencing the outcome of total knee replacement (TKR)~     surgery. Therefore, assessing bone quality preoperatively could help the surgeon in the~     choice of the most appropriate prosthetic implant.~      The primary goal of this study is to measure serum and tissue levels of some proteins~     involved in bone remodelling.~   "
121935|NCT01971463|"~     This study is a non-randomized, Phase 2 clinical trial designed to assess optical cerebral~     blood flow (CBF) response to bolus normal saline. Subjects will have had an ischemic stroke~     within 96 hours of enrollment. The study intervention will be a one hour monitoring session.~     There will be a 15 minute baseline measurement period, followed by intravenous administration~     of 500cc of 0.9% NaCl over 30 minutes, and finally 15 minutes of monitoring post-bolus. All~     study measurements will cease after 1 hour. Subjects will be followed during their~     hospitalization for 7 days or until discharge, whichever is sooner, to monitor for adverse~     events and to collect clinical information.~   "
121936|NCT01971450|"~     Local, prospective, multicenter, non-comparative, non-interventional, observational study. It~     is planed to assess compliance of patients with PH (pulmonary hypertension) with the~     physician's recommendation in real practice.~   "
121900|NCT01971918|"~     The objective of the study is to evaluate two therapeutic strategies: early switch or~     therapeutic intensification in patients with spondyloarthritis in case of secondary~     treatment failure suspicion to a first monoclonal antibodies anti-TNF definite by increase of~     ASDAS and positivity to ADAb.~      Patients and Methods:~      Multicentric randomized prospective study. Duration of inclusion 30 months. Duration of~     follow-up 24 months. 104 patients with spondyloarthritis treated with infliximab or~     adalimumab will be included if their ADAb dosage is positive, and they will be randomized~     (1:1) in two groups : early switch where treatment will be change to another anti-TNF, or~     therapeutic intensification where interval between two injections will be shortened.~     Patients will be evaluated clinically (ASDAS) and biologically (ADAb) at 12 weeks then at 24~     weeks. Principal outcome will be the variation of ASDAS between baseline and end of the~     study. Number of patients to be included has been determined statistically from a preliminary~     study (power >98% for ASDAS variation of 20% on week 24).~      Expected results:~      On week 24, we expect a better response and a greater proportion of patients in remission in~     the early switch arm compare to the therapeutic intensification arm.~   "
121901|NCT01971905|"~     To investigate the ability of perfusion CT/US-scanning to facilitate recognition of different~     tumour sub-types in small renal masses less than 7 cm by non-invasive imagining technology.~   "
121902|NCT01971892|"~     Acute respiratory failure may occur early in the postoperative course, requiring endotracheal~     intubation and mechanical ventilation in selected patients, thus increasing morbidity and~     mortality and prolonging intensive care unit (ICU) and hospital stay.We will perform a~     multicenter, prospective, randomized clinical trial to compare the efficacy of non invasive~     ventilation (NIV) which associated pressure support ventilation (PSV: 5 to 15 cmH2O) and~     positive end expiratory pressure (PEEP: 5 to 10 cmH2O) with standard oxygen therapy in the~     treatment of postoperative acute respiratory failure. We also set out to examine the~     hypothesis that early application of NIV may prevent intubation and mechanical ventilation in~     patients who develop acute respiratory failure after abdominal surgery.~   "
121903|NCT01971879|"~     Prospective, monocentric, randomised, double-blind study with 20 patients enrolled to be~     explored twice through a Cross-over strategy to determine whether remote preconditioning~     improves arteritic patients' ability to walk.~   "
121904|NCT01971866|"~     This study aims to investigate the advantages of using AlignRT, a commercially available, FDA~     approved camera-based imaging system for proton therapy patients prior to and during their~     radiation treatment delivery.~   "
121905|NCT01971853|"~     All healthcare providers strive continually to improve the outcome of their treatment~     approaches. The investigators hypothesize that preventive analgesics administered before a~     child is sedated with a Demerol-Vistaril regimen will improve the outcome of a sedation.~   "
121906|NCT01971840|"~     Coordinated project whose objectives are: a) to assess the effectiveness of a physical~     activity intervention (MOVI-KIDS) on preventing obesity and improving fitness during the~     adiposity rebound period; and b) to examine the effectiveness of MOVI-KIDS on reducing the~     carotid intima-media thickness.~   "
121907|NCT01971827|"~     Coordinated project whose objectives are: a) to test the effectiveness of a promotion of~     physical activity intervention (MOVI-KIDS) on preventing obesity; and b) to improve the~     academic performance in both children with and without attention deficit hyperactivity~     disorder (ADHD)~   "
121908|NCT01971814|"~     The aim of this study is to a.) evaluate whether early serum infliximab levels are predictive~     of avoidance of colectomy, b) evaluate whether serum albumin levels correlate with serum~     infliximab levels, and c) evaluate whether serum tumor necrosis factor levels are inversely~     correlated with serum infliximab levels.~      In patients hospitalized for severe ulcerative colitis and treated with high-dose infliximab,~     we predict that early serum infliximab levels (24, 48, and 72 hour) will be positively~     associated with clinical response and avoidance of colectomy.~   "
121909|NCT01971801|"~     Urinary incontinence (UI) is a common disorder among older women that greatly affects quality~     of life. Emerging evidence from observational studies links vitamin D insufficiency with UI.~     Prior to a larger intervention trial of vitamin D among older women with low serum vitamin D~     levels and urgency UI, we propose a pilot study in 100 older women comparing weekly, oral~     vitamin D3 50,000 IU to placebo. We hypothesize that adequate vitamin D supplementation will~     improve UI symptoms in older women with vitamin D deficiency. Changes in UI-episodes will be~     assessed by a 7-day bladder diary and other validated symptom measures administered at~     baseline and after 12-weeks of intervention. Serum calcium and 25(OH)D levels will be~     monitored. The expected outcomes will provide new knowledge regarding the impact of vitamin D~     supplementation on UI symptom improvement and inform a larger, randomized controlled clinical~     trial involving vitamin D supplementation.~   "
121910|NCT01971788|"~     Residual thrombosis of stent struts may occur after the end of primary angioplasty and~     determine distal embolization and further myocardial damage. Bivalirudin is considered the~     most appropriate antithrombotic drug in the setting of primary PCI, but an initial increase~     in stent thrombosis has been reported. In order to overcome this potential adverse event, a~     prolonged infusion of bivalirudin after the end of PCI has been proposed.~      This aim of this study is to test whether the use of long-term bivalirudin infusion, as~     compared to the intra-procedural only administration, reduces residual thrombosis of stent~     struts evaluated by optical coherence tomography (OCT) at the end of primary PCI and at 3-5~     days follow-up.~      A subgroup of patients enrolled in the MATRIX (Minimizing Adverse haemmhorragic events by~     TRansradial access site and AngioX study) study will be selected showing the following~     inclusion criteria:~        -  patients affected by STEMI undergoing primary PCI with stent implantation and randomised~          to bivalirudin treatment,~        -  patients who, in addition to the infarct related lesion, show at least one critical~          stenosis of other coronary vessels suitable for staged-PCI,~        -  patients whose anatomy is suitable for OCT evaluation.~   "
122000|NCT01970605|"~     This web based e-Registry will be international, multi-center and prospective. Silver Graft~     e-Registry to assess the long term clinical benefit of Silver Graft in an unselected patient~     population~   "
122596|NCT01962792|"~     Phase 1 will be an open-label study. The dose escalation portion of the study is designed to~     establish the MTD of ibrutinib in combination with carfilzomib with or without dexamethasone.~      Phase 2b will be an open-label, multicenter study designed to evaluate the overall response~     rate when ibrutinib is administered in combination with carfilzomib and dexamethasone.~   "
121911|NCT01971775|"~     Surgery is the first standard treatment for stomach cancer, but it still has negative factors~     such as bleeding, leakage, closure, surgery part infection and cardiovascular and lung~     complication by general anesthesia.~      electric cautery is used extensively in surgery room due to the utility of simultaneous~     severance and hemostasis. In some case, the electric current from vitality electrode may~     unexpectedly stimulate or damage nearby muscles and nerves. Ultrasonically activated shears~     (UAS) is a device to transform the protein of organ for organ incision or hemostasis. General~     advantages possibly include shortened operating time, decrease of operative blood loss, and~     relatively less damages to the normal organ. UAS is commonly used in the operation room,~     which is now considered as a secure and useful medical device for for tissue dissection and~     coagulation. Also, it is expected to lower the risk of surgery by reducing operating time and~     blood loss.~      However, clinical evidence is not sufficient for this device until now. Therefore, in this~     study,~        1. Evaluate the utility, efficacy, and safety of energy based device, in the case of open~          gastrectomy~        2. Would like to compare the following two kinds of energy based devices. A. For~          conventional monopolar electrosurgery group : dissection and sealing will be conducted~          by conventional monopolar electrocautery device B. For UAS group : dissection and~          sealing will be conducted by UAS~   "
121912|NCT01971762|"~     Staphylococcus aureus bacteremia: impact of an intervention program in improving the clinical~     management and review of the clinical and molecular epidemiology.~   "
121913|NCT01971749|"~     Register of treatment of unprotected left main coronary artery stenosis in Andalucia~     (RETRATO).~   "
121914|NCT01971736|"~     We study the efficacy of 1 pass of stacking pulses of long pulse 1064nm laser on the face for~     skin tightening immediately post laser and 3 months follow up.~   "
121915|NCT01971723|"~     It has been suggested that high amounts of total serum testosterone levels correlate with~     higher lean body mass, lowered fat mass, greater muscle strength, and faster recovery. These~     suggestions drive athletes and body builders to find ways to raise their testosterone levels.~     Many athletes and bodybuilders look to alternative methods to anabolic steroids in order~     increase their testosterone levels without legal repercussions or physiological side effects.~     Herbs and other plant extracts have been introduced as a possible source to naturally boost~     testosterone levels. Research supporting the use of herbs and plant extracts has been shown~     to be equivocal. However, evidence in studies with hypogonadal men suggests that longjack~     root may naturally boost testosterone levels.~      Onnit Labs, LLC has packaged this supplement (T+) which claims it can naturally boost~     testosterone and lower estrogen levels and subsequently improve performance. This product is~     a powder (11g) that is mixed with 16 oz of water and consumed 20 minutes prior to anaerobic~     workouts, such as high intensity weight training.~      T+ is a multi-ingredient supplement that consists of vitamins B5 and B6, magnesium aspartic~     acid, mucuna pruriens, longjack root, nettle root, red clover luteolin, resveratrol, beta-~     alanine, branch chain amino acids, L- glutamine, Bioperine, and Fibersol 2.~      The active ingredients purported to boost plasma testosterone levels are mucuna pruriens,~     longjack root, and magnesium aspartic acid. The active ingredients claimed to lower plasma~     estrogen concentrations are red clover, luteolin, resveratrol and nettle root. All other~     ingredients (Branch Chain Amino Acids and Beta-Alanine) have been documented to improve~     exercise performance.~      It is hypothesized that there will not be any physiological changes after supplementation of~     T+. It is also hypothesized that performance will not be affected by the supplementation of~     T+.~   "
121916|NCT01971710|"~     The goal of the ACCLAIM (Advancing Community-Level Action for Improving MCH/PMTCT) project is~     to increase community demand for, uptake of, and retention in Maternal and Child Health (MCH)~     and/Prevention of Mother-to-child transmission of HIV (PMTCT) services to improve country~     progress toward elimination of pediatric HIV/AIDS.~   "
121917|NCT01971697|"~     This study will be conducted at Mulago Teaching Hospital. Patients coming to the ER with an~     orthopaedic injury will be approached. If a patient consents to be part of the study, they~     will complete a questionnaire. Participation in the study will end as soon as the~     questionnaire is completed.~   "
121918|NCT01971684|"~     The purpose of this study is to understand physician treatment decisions in selecting~     specific second line treatments in pediatric ITP and to determine the effectiveness of~     different second line ITP treatments. Eligible patients are those ages 1-18 years who are~     starting on a new second line treatment for ITP, defined as any treatment other than IVIG,~     steroids, anti-D globulin, or aminocaproic acid. Enrolled patients remain on the study for~     approximately one year.~   "
121919|NCT01971671|"~     To understand breast milk composition during different lactating stages.~   "
121920|NCT01971658|"~     This is a phase III, multicenter, prospective with a clinical benefit, open-label and~     randomized study to compare two different treatments : Velcade (Bortezomib) Thalidomide~     Dexamethasone (VTD) versus Velcade (Bortezomib) Cyclophosphamide Dexamethasone (VCD) as an~     Induction Treatment prior to Autologous Stem Cell Transplantation in patients with Newly~     Diagnosed Multiple Myeloma.~      Eligible patients will be randomized into 2 treatment arms. Each patient will receive 4~     consecutive 21 day cycles of an induction treatment with either VTD or VCD.~   "
121921|NCT01971645|"~     If preservative-free dexamethasone 0.1 mg/kg (max dose 4 mg) is added to ropivacaine 0.5% 2~     mg/kg (max dose 100 mg), then post-PACU opioid consumption will be reduced by 33%.~   "
121922|NCT01971632|"~     The primary objective was to demonstrate the superiority of OXN over placebo over time from~     the initial dose of study medication to multiple pain events (inadequate analgesia) during~     the double blind phase.~   "
121923|NCT01971619|"~     To investigate the effect of vitamin D deficiency on the development of arrhythmia in~     patients with acute myocardial infarction.~   "
121924|NCT01971606|"~     Periprocedural treatment with high-dose statins is known to have cardioprotective and~     pleiotropic effects, such as anti-thrombotic and anti-inflammatory actions.~      -Objective: to determine whether preoperative rosuvastatin loading is independently~     associated with reduced myocardial ischemia and clinical outcomes in patients with stable~     angina undergoing isolated off-pump coronary bypass (OPCAB) in patients with acute coronary~     syndrome.~      Study design~        -  Prospective, double-blinded, single-center study of each 117 subjects enrolled~        -  Subjects with acute coronary syndrome who meet all inclusion and exclusion criteria will~          be enrolled preoperatively.~        -  Eligible subjects will be randomized 1:1 to A) High-dose rosuvastatin (n=117) vs. B)~          Placebo (n=117).~        -  The amount of preoperative administration of high-dose rosuvastatin will be 60mg of a~          total~        -  All subjects will undergo OPCAB procedure. - The primary and secondary endpoints will be~          compared at 30 days and 2 years postoperatively between two groups~   "
122619|NCT01962493|"~     The aim of this study is to compare the stain effect on teeth of twice daily brushing with a~     67% sodium bicarbonate containing toothpaste versus standard toothpaste (not containing~     sodium bicarbonate) for six weeks whilst using a chlorhexidine digluconate 0.2% mouthwash.~   "
121925|NCT01971593|"~     Hypothesis:~      By blocking aldosterone signaling in patients with Tetralogy of Fallot, Transposition of the~     great vessels with a prior atrial switch, and single ventricle Fontan patients, incident~     heart failure will be delayed, symptoms of heart failure ameliorated, and risk of arrhythmias~     decreased through decreases in myocardial fibrosis.~      Half of enrolled patients will complete an SF-36 quality of life questionnaire, perform a 6~     minute walk, and have blood drawn for biomarker analysis at enrollment, again after 3 months~     without therapy, after 6 months on therapy, then finally after 12 months of eplerenone~     therapy. Half of enrolled patients will have the 3 month drug free period at the end of 12~     months on therapy. Patients will be randomly assigned to drug free period up front versus at~     the conclusion of the trial period. Eplerenone will be started at a dose of 25mg and titrated~     up to 50mg at 4 weeks if tolerated. Blood will be drawn for basic metabolic panel analysis at~     enrollment, 3 months, 4 months to allow for dose titration, and at 6 and 12 months for~     monitoring.~   "
121926|NCT01971580|"~     Hypothesis:~      Patients with a Fontan type palliation are limited by preload, or the rate at which blood~     returns to the heart after passively traversing the pulmonary capillary bed. By decreasing~     pulmonary vascular resistance using an endothelin receptor antagonist, both ventricular~     filling pressures and volumes will increase with a simultaneous decrease in systemic~     impedance to flow and decrease in central venous pressures, leading to an improved capacity~     to increase cardiac output, and thereby an improvement in patient functional status.~      Patients who are candidates for the study will be randomized to a double-blind single~     crossover study. Therapy with either ambrisentan or placebo will be continued for 12 weeks,~     with a 2 week washout period between treatment periods. Subjects will be subjected to a VO2~     max test to evaluate exercise capacity at enrolment, and on the last day of each treatment~     period. As a component of the VO2 max testing the patient's VE, VCO2, VE/VCO2 slope,~     ventilatory anaerobic threshold (VAT), peak work, efficiency, and other physiologic~     parameters as typically obtained from cardiopulmonary testing will be assessed. In addition,~     each patient will be asked to complete an SF-36 quality of life questionnaire at enrollment,~     and on the last day of each study period.~   "
121927|NCT01971567|"~     The purpose of this study is to determine whether the addition of High-resolution,~     relational, resonance-based, electroencephalic mirroring (HIRREM) to usual care will improve~     insomnia symptoms based on changes in the Insomnia Severity Index at two months following~     completion of the intervention, compared to placebo plus usual care.~   "
121928|NCT01971554|"~     This is a study of the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD)~     of MK-8666 in participants with type 2 diabetes mellitus (T2DM). Participants enrolled in~     this trial would be either treatment-naive or have washed off of oral anti-hyperglycemic~     agents. MK-8666 is planned to be administered orally for up to 2 weeks. The primary~     hypothesis for this study is that after 14 days of once daily treatment with MK-8666, at a~     dose that is safe and well tolerated, the placebo-corrected fasting plasma glucose reduction~     from baseline is ≥34 mg/dL.~   "
121929|NCT01971541|"~     The proposed study is a randomized, controlled trial that will assess whether two group~     interventions for PTSD - Mindfulness-Based Stress Reduction (MBSR) and Cognitive Processing~     Therapy-Cognitive only (CPT-C) result in similar improvements in PTSD symptoms and~     health-related quality of life (QOL). One hundred fifty-two Veterans with PTSD will be~     randomized to MBSR (n = 76) or CPT-C (n = 76). Comprehensive assessments will take place~     post-treatment and 3 months later.~   "
121930|NCT01971528|"~     Fatigue is one of the most common symptoms in individuals with Parkinson's Disease (PD). Past~     research indicated that more than half of the individuals with PD demonstrated fatigue~     symptom. The severity of fatigue was also correlated to the quality of life in individuals~     with PD. Finding the contributions of the central and the peripheral factors to fatigue and~     developing an effective training program for individuals with PD are very important.~      Fatigue can be categorized into peripheral or central causes. The central fatigue and~     voluntary activation failure originate from the decrease in motivation or the reduction of~     the conduction within corticospinal tracts. Long term activation failure and central fatigue~     will cause disuse of muscle and result in peripheral weakness and peripheral fatigue.~     Quantifying the weighting of central versus peripheral factors contributing to the fatigue in~     people with PD is important.~      Most of the conventional strength and endurance training programs were based on the~     researches of young groups. Almost no training program was design for enhancing the voluntary~     activation level and relief the central fatigue. Seeking an appropriate training program to~     enhance central activation is very important for individuals with PD who prone to fatigue.~      Previous studies have shown that increasing afferent input by peripheral electrical~     stimulation (ES) at sensory threshold enhanced the plasticity of contralateral primary~     sensory cortex, the excitability of corticospinal tracts, and the functional performance in~     young adults. Combining afferent input with strength training was more effective than~     strength training along. ES, which is easy to quantify the dose of afferent input, is a~     feasible method to provide such training.~      The purpose of this project is to investigate the effects of the combination of ES at sensory~     threshold and strength training on voluntary activation in the individuals with PD.~   "
121931|NCT01971515|"~     This is a Phase 1, first-in-human, open-label, non-randomized, dose escalation, trial to~     explore the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and clinical~     activity signals of MSC2363318A.~   "
121932|NCT01971502|"~     The objective of the single rising dose part (SRD) is to investigate safety, tolerability,~     pharmacokinetics, and pharmacodynamics of single rising doses of BI 1060469 in healthy male~     subjects. The objective of the food effect part (FE) is to investigate the relative~     bioavailability of BI 1060469 tablets in healthy male subjects in fed or fasted state.~   "
121933|NCT01971489|"~     This phase I trial studies the side effects and the best doses of buparlisib, gemcitabine~     hydrochloride, and cisplatin in treating patients with solid tumors that have spread to other~     places in the body. Buparlisib may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride~     and cisplatin, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. Giving buparlisib, gemcitabine hydrochloride,~     and cisplatin may be a better treatment for solid tumors.~   "
121934|NCT01971476|"~     The present trial will be performed according to an open design to determine the maximum~     tolerable dose (MTD) by evaluation of dose-limiting toxicity (DLT) of volasertib in~     paediatric leukaemia and solid tumours in the age group 2 to less than 12 and 12 to less than~     18 years. A further objective is to collect data on safety, tolerability, toxicity, efficacy~     (preliminary activity), pharmacokinetics and pharmacodynamics of volasertib in paediatric~     cancer patients~   "
122546|NCT01963442|"~     To investigate the non inferiority of a short lasting antibiotic treatment (3 days) when~     compared to a long lasting antibiotic treatment (8 days), at Day 15 after the beginning of~     treatment in terms of clinical efficacy, in adults admitted to emergency services for a non~     severe Community Acquired Pneumonia (PAC), who responded well to 3 days of beta-lactamin~     treatment (3GC or A/AC).~   "
121937|NCT01971437|"~     This is an ethically approved randomised controlled study looking at whether~     Cystodistension(filling the bladder with fluid under pressure) provides any benefit over~     cystoscopy alone (looking in the bladder) in women with refractory overactive bladder. Urine~     samples will also be assessed for underlying infected cause of OAB using urinalysis,~     microscopy and culture and cytokine assays (In collaboration with the University of Kent). We~     hypothesize that Cystodistension has a therapeutic benefit to women with refractory OAB and~     the there is an increase prevalence in chronic urinary infections with raised cytokines in~     women with refractory OAB.~   "
121938|NCT01971424|"~     Magnesium deficiency is associated also in the elderly with low physical performance;~     nevertheless trials about the effect of supplementation of magnesium on physical performance~     are not available in old people. The aim of our study is to investigate whether 12-weeks of~     oral magnesium supplementation improves physical performance in healthy elderly women~   "
121939|NCT01971411|"~     In order to make bone health a reality for older adults, we need to consider the prevalence~     of Vitamin D deficiency in relation to environment latitude as well as vitamin D~     supplementation. Darker skin pigmentation and aging are known factors influencing the body's~     ability to synthesis adequate amounts of Vitamin D. The aim of this project is to document~     vitamin D deficiency in elderly African American women living in a southern latitude.~   "
121940|NCT01971398|"~     This study is designed to increase knowledge and awareness to prevent Fetal Alcohol Syndrome~     in Russian children through development of printed FAS education materials targeting women of~     childbearing age in Russia. Alcohol abuse is a major public health problem in Russia. The~     rates of FAS and Alcohol Related Neurodevelopmental Disorders (ARND) in Russia are not~     precisely known. At this time, there are no programs to prevent FAS in Russia. The results of~     our previous study, focus groups with health professionals, pregnant women and their~     partners, non-pregnant women, and women with alcohol dependency, indicated limited knowledge~     about FAS, misconceptions about alcohol use during pregnancy, and a lack of materials and~     print resources related to this topic. Based on the initial findings, this proposal aims to~     develop and evaluate in a clinical trial informational brochures for women to increase~     knowledge and reduce drinking during pregnancy in Russia. The main hypotheses to be tested~     are:~        -  1. Compared to the control group (CG) of women who receive a standard locally available~          flyer with health recommendations, women in the experimental groups who are exposed to~          printed information on FAS will show significantly more knowledge about FAS,~          significantly less acceptance of any alcohol use during pregnancy, and reduced drinking~          at one month follow-up assessment.~        -  2. The group exposed to a brochure with negative images (IGN - Intervention group with a~          negative brochure) regarding drinking during pregnancy will show significantly greater~          change in the predicted directions compared to the group exposed to positive images (IGP~          - Intervention group with a positive brochure) at the one month follow-up assessment.~   "
121941|NCT01971385|"~     Subjects with a history of recurrent herpes labialis will be sensitized with either 2% SADBE~     or placebo. Following this, subjects sensitized with 2% SADBE will received.2% sqauric acid~     or.5% squaric acid on their cold sore within 72 hours of a recurrence. Subjects sensitized~     with placebo solution will receive placebo solution on their cold sore within 72 hours of a~     recurrence. Subjects will be followed for up to 6 mos after application of study medication.~   "
121942|NCT01971372|"~     Specific Aim 1: To identify differences in pain perception and satisfaction with pain control~     in women undergoing urogynecologic surgery receiving nonsteroidal anti-inflammatory (NSAIDS)~     postoperatively by oral ibuprofen, intravenous ibuprofen, or intravenous ketorolac. Specific~     Aim 2: To compare the differences in narcotic usage and medication side effects.~   "
121943|NCT01971359|"~     This study is determining the clinical outcomes, based on neurological testing, for the~     parafascicular minimally invasive clot evacuation technique. We will collect data from the~     time of surgery up until 90 days post procedure. We will also be looking at financial data as~     well.~        -  H(0): there is no economic benefit to the system with early surgical intervention for~          ICH~        -  Alternative Hypothesis:H(1) Assuming clinical equipoise, i.e., no benefit in clinical~          outcome with early surgical intervention (null hypotheses) H(0) is correct), the ability~          to accelerate the patients care from the entry point to the exit point will result in a~          significant economic advantage to the system through cost reduction.~   "
121944|NCT01971346|"~     The purpose of this study is to determine the relationship between two types of cell signals~     (type I IFN and TNF) in psoriatic skin prior to and during treatment with etanercept and~     correlate that information with the degree of the improvement in the psoriasis.~   "
121945|NCT01971333|"~     The arterial system compliance is compromised in liver cirrhotic patients. Dynamic preload~     variables are either pressure-based (e.g.pulse pressure variation; PPV), flow-based (e.g.~     stroke volume variation; SVV), or volume-based (plethysmographic variability index; PVI). It~     is not yet clear that dynamic preload parameters based on which mechanism will be accurate to~     predict fluid responsiveness in the cirrhotic patients. Therefore, this study aimed to~     claried which dynamic preload parameters would be more accurate during the liver~     transplantation.~   "
121946|NCT01971320|"~     Oropharyngeal dysphagia induces aspirations which could be responsible of aspiration~     pneumonia and denutrition. It could be present in the majority of central neurological~     disease (degenerative or vascular disease), which explains that it is the first case of~     mortality in stroke. Two pilot studies realised by our research group aimed to demonstrate~     that sensitive transcutaneous electrical stimulation could improve swallowing coordination~     and reduce aspirations. This technique could be used at home.~      The aim of this study is to demonstrate that sensitive electrical stimulation could improve~     oropharyngeal dysphagia in hemispheric stroke patients. 118 patients should be included in~     seven centers. Sensitive electrical stimulation will be applied either as active stimulation,~     either as a placebo. Active electrical stimulation will be realised at 80 hz during 30~     minutes, under motor threshold and above sensitive threshold. It will be administrated via~     surface electrodes over the hyoid bone. Patients will be separated by randomisation.~      Patients will be evaluated before and after 6 weeks of use. Methods will evaluation~     questionnaire, clinical examination and videofluoroscopy. The time of use will also be~     collected.~      We wish to demonstrate that transcutaneous electrical stimulation is able to improve~     oropharyngeal dysphagia in stroke.~   "
121947|NCT01971307|"~     Although effective treatments for psychosocial symptoms and disorders are available, patients~     frequently do not receive the most appropriate and effective treatment for their symptoms~     because of inappropriate and unstructured diagnostics of psychosocial symptoms in general~     practice. The hypothesis is that by using the intervention SGE-PsyScan the clinical symptoms~     of patients can be assessed more uniformly and earlier as opposed to the GPs' assessment in~     usual care. As a result, patients are supposed to start earlier with a treatment that fits~     the type and severity of their symptoms better.~      The patients will be randomly assigned to either receive the SGE-PsyScan or usual care.~   "
121948|NCT01971294|"~     Urinary symptoms must be frequent in Scleroderma. In one hand, mobility limitation by joint~     stiffness and skin sclerosis, forced diuresis due to heart involvement (cardiomyopathy or~     pulmonary hypertension), diuretics use and corticoid-induced hyperglycaemia, as well as~     narcotic medication use, puts patients at higher risk of secondary bladder filling and~     voiding dysfunction. In another hand, few case report and small sample observational studies~     have identified a specific sclerosis of the urinary tract. Those two mechanisms must be more~     frequent in the diffuse cutaneous form of scleroderma (dcSSc) compare to the limited one~     (lcSSc). But prevalence or incidence is unknown.~      Urinary symptoms are seldom reported by those suffering from them and are rarely part of a~     systemic evaluation. In a threatening disease, urinary symptoms assessment might seem to be~     of no priority. But LUTS have a real impact on many aspect of everyday living. Furthermore~     urinary tract involvement might predispose to urinary tract infection due to flow limitation~     and stagnation. Since it is an inner fibrosis it might be associated with a more aggressive~     form of disease conferring a greater loss of physical function, higher risk for hospital~     admission and death.~      Thus, identifying urinary symptoms would permit to address specific rehabilitation or~     medication therapy, in order to minimize the consequences of the bothersome symptoms and~     identify those subjects at higher risk of urinary infection, aggressive disease/loss of~     function or death.~      This study will also give basement to build an interventional study directed toward LUTS~     treatment in this population.~      In this prospective cohort we would like to:~        -  Compare the prevalence of lower urinary tract symptoms (LUTS) in diffuse and limited~          forms of systemic sclerosis.~        -  Determine the prevalence (at inclusion) and incidence (in a two years period) of LUTS~          among patients suffering from systemic sclerosis.~        -  Evaluate the impact of LUTS symptoms on Quality of life.~        -  Compare the discrimination ability of Cochin-hand score and HAQ score to predict~          incontinence in this population.~        -  Evaluate the association between LUTS symptoms, hospital admission rate, urinary tract~          infection, mortality and loss of autonomy.~   "
121949|NCT01971281|"~     The study is a prospective, double arm, non-randomized, open label pilot trial, designed to~     study the safety, feasibility and preliminary efficacy of a medical device, the NovoTTF-100L~     concomitant with gemcitabine or concomitant with gemcitabine plus nab-paclitaxel, for~     front-line therapy of pancreatic adenocarcinoma. The device is an experimental, portable,~     battery operated device for chronic administration of alternating electric fields (termed~     TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated~     electrode arrays.~   "
121950|NCT01971268|"~     In patients that received a T3 (Biomet 3I) dental implant, does the use of platform-switch~     concept compared to the use of platform-matched concept, refrain marginal bone loss during~     osseointegration phase (t=12 weeks =T1) and from then to final rehabilitation (t= placement~     of the final restoration = at 18 weeks=T2)~   "
121951|NCT01971255|"~     Background:~      - Researchers want to know if a certain type of antibody in the blood affects whether people~     get influenza (the flu). They will study 2 different groups with different levels of anti-HA~     antibodies and expose them to the flu virus. They will study how the flu develops in a~     healthy person. This may lead to future studies to develop new vaccines and treatments for~     the flu.~      Objective:~      - To study how people can be protected from flu infection.~      Eligibility:~      - Healthy volunteers 18 to 50 years of age.~      Design:~        -  Participants will be screened through the use of a medical history, physical exam, and~          laboratory tests.~        -  Groups of 7 participants will stay in an isolation unit in a hospital for at least 9~          days with no visitors.~        -  Participants will be screened again upon admission. They will also have:~        -  ECG: soft electrodes will be stuck to the skin. A machine will record the heart s~          electrical signals.~        -  Echocardiogram: a small probe will be held to the chest to take pictures of the heart.~        -  Lung tests: participants will blow into a machine.~        -  They will also have nasal fluid collected. This will be done either with a swab or with~          a tube of water washing out the nose. This will be done once every day.~        -  The flu virus will be sprayed into the participant s nose. This will be done only once.~        -  Participants will complete a questionnaire on day 1 and twice a day after that for 14~          days.~        -  A medical team will watch participants 24 hours a day. They will go home after 2 days of~          negative flu tests.~        -  Participants will have 4 follow-up visits over 8 weeks.~   "
121952|NCT01971242|"~     This study is a clinical trial in patients with Parkinson's disease, of a drug called~     Exenatide which is already licensed for the treatment of patients with Type 2 Diabetes. There~     have been several groups that have confirmed that Exenatide has beneficial effects on nerve~     cells when tested in the laboratory, that raises the possibility that Exenatide may slow down~     or stop the degenerative process of Parkinson's disease. In an open label trial in patients~     with Parkinson's disease who self administered the drug for 1 year, we have previously shown~     that the drug is well tolerated and shows encouraging effects on the movement and~     non-movement aspects of the disease, even 2 months after patients stopped administering the~     drug. The next step is therefore to formally evaluate whether Exenatide really is a potential~     neuroprotective drug, i.e. stops the nerve cells dying in Parkinson's disease, by~     conducting a double blind, placebo controlled trial.~   "
121953|NCT01971229|"~     Surgery is a stress on the body and recovering well after surgery is very important to~     patients and their doctors. It is therefore important to prepare patient's bodies for the~     stress of surgery, and one way to do this is to provide proper nutrition. In the past,~     patients were asked to prepare for surgery by fasting from midnight before surgery. Today, it~     is known that this practice is not beneficial to patient's recovery. In fact, it has been~     recognized that drinking a sugary beverage (e.g., juice) before surgery stimulates the~     production of insulin, which is a hormone that helps make the proteins needed for wound~     healing after surgery. This is currently practiced at the MUHC. It might also be beneficial,~     however, to drink a beverage that contains sugar and whey proteins (a protein isolated from~     milk) before surgery. In fact, whey proteins stimulate insulin and may also have the added~     benefit of improving muscular strength. In this study, investigators will measure the level~     of insulin produced after drinking a carbohydrate (i.e., sugar)-whey protein beverage to~     determine how it compares to the level of insulin produced after drinking the sugary beverage~     used at the MUHC.~   "
122547|NCT01963429|"~     This phase 3 study is to evaluate the effectiveness of the comparison between radiofrequency~     ablation and hypofractionated proton beam radiation.~   "
121954|NCT01971216|"~     Primary hypotheses~      1. The use of a relaxation tape by breastfeeding mothers that will be given starting at week~     2 postpartum, will result in : i) reduced maternal stress and anxiety ii) the production of a~     higher volume of breast milk iii) lower milk cortisol concentrations iv) favourable effects~     on infant behaviour (less crying, more sleeping) v) higher milk intake by the infant vi) more~     optimal growth, specifically higher lean mass and lower fat mass (body composition)~      Secondary hypotheses (i) Infant temperament/behaviour and gender influence milk and energy~     intake and hence early growth and body composition (ii) Non-nutrient factors in breast milk~     (hormones including ghrelin and leptin) influence infant behaviour and feeding patterns and~     hence infant growth and body composition.~   "
121955|NCT01971203|"~     The primary objective of the study is to determine whether quetiapine extended-release in~     combination with cognitive behavioral therapy (CBT) is more effective than CBT plus placebo~     in treating depressive and anxiety symptoms in patients with both major depression and~     generalized anxiety disorder. Approximately 64 individuals (adults 18-65) will be randomly~     assigned to treatment group for 16 weeks. Weekly CBT sessions will be conducted lasting about~     45 minutes and weekly visits with the study psychiatrist lasting about 20 minutes in which~     medication will be discussed. Both clinician administered and self-report measures will be~     used to compare groups before and after 16 weeks.~   "
121956|NCT01971190|"~     Central serous chorioretinopathy (CSC) is a self-limiting disease that usually associated~     with good visual prognosis. In some cases, however, CSC may persist and result in permanent~     retinal or retinal pigment epithelium (RPE) damage. Therefore, if the disease is persistent~     beyond the acute phase, an active treatment should be considered to prevent an irreversible~     damage to retinal function.~      The pathophysiology of CSC is associated with abnormal choroidal circulation. Indocyanine~     green angiography (ICGA) has revealed dilated and congested choroidal vessel and leakage into~     the extracellular space that appears as area of hyperfluorescence seen in middle and late~     phase in eyes with CSC.~      A goal of treatment has been focused on reducing choroidal hyperpermeability. Currently,~     photodynamic therapy with verteporfin (PDT) and intravitreal anti-VEGF (vascular endothelial~     growth factor)antibody injection are being tried in order to treat chronic CSC. PDT reduces~     choroidal hyperpermeability by inducing hypoperfusion of the choriocapillaris in the short~     term and choroidal vascular remodeling over time. Intravitreal anti-VEGF injection for the~     treatment of CSC also effectively reduces choroidal hyperpermeability by blocking vascular~     leakage. Both methods have shown to be effective with good functional outcome for treating~     chronic CSC in many reports, but until now there is no established standard treatment~     protocol for chronic CSC.~      Bevacizumab (Avastin) and ranibizumab (Lucentis) have been used widely as anti-VEGF~     therapeutic agent for the treatment of age related macular generation (AMD) and macular edema~     of various reasons. A newly developed anti-VEGF drug, aflibercept (Eylea○R), shows higher~     affinity to VEGF and has a longer duration of effect in the vitreous.FDA approved aflibercept~     to treat wet type AMD and macular edema due to central retinal vein occlusion.~      Until now, no study has been reported on the efficacy and safety of aflibercept for treating~     CSC. The aim of this study is to evaluate the efficacy and safety of intravitreal aflibercept~     injection for the treatment of idiopathic CSC~   "
121957|NCT01971177|"~     This clinical study is a randomized, controlled, open, prospective, multi-centre,~     multi-surgeon post-market-clinical-follow-up study to investigate the impact of cataract~     grade on the efficacy and safety of femtosecond laser assisted lens fragmentation to support~     phacoemulsification of the cataractous lens prior to intraocular lens (IOL) implantation.~   "
121958|NCT01971164|"~     The purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK),~     and pharmacodynamics (PD) of sequential ascending doses of JTZ-951 administered for 15 days~     in anemic subjects with end-stage renal disease (ESRD) receiving hemodialysis.~   "
121959|NCT01971151|"~     RATIONALE: Exposure in vivo therapy aims to reduce pain-related fear - a key maintaining~     factor of chronic low back pain- while increasing level of daily functioning, despite the~     pain. This is done by exposing patients to their most feared activities/movements, while~     behavioral experiments are performed that serve to correct catastrophic (erroneous) beliefs~     about pain. Yet, performing exposure exercises might be very threatening for patients and~     might encourage them to build in subtle safety-seeking behavior. Whether safety-seeking~     behavior should be allowed or not during therapy is heavily debated. Whereas some argue that~     it will only interfere with therapeutic progress because it prevents the disconfirming~     experience exposure tries to offer, other argue that it will facilitate therapeutic progress~     because it enhances one's sense of control, if used judiciously. So far~     (clinical-)experimental studies have provided mixed evidence nor have they lead to any~     clinical recommendation. Hence, in a replicated single-case experiment, we will compare~     exposure therapy with versus exposure without safety-seeking behavior versus exposure only.~      STUDY POPULATION: Participants are chronic low back pain patients seeking treatment, who~     fulfill all inclusion and exclusion criteria and participate voluntarily.~      INTERVENTION: All participants receive exposure therapy at the rehabilitation department of~     the academic hospital in Maastricht, but with different recommendations for the use of~     safety-seeking behavior.~      We will assess: 1) daily measures of fear, pain intensity and self-reported achievement of~     goals and 2) non-daily measures of pain disability, pain-related fear, pain catastrophizing,~     pain solutions, need to control and safety-seeking behavior. To measure to the influence of~     safety-seeking behavior on actual level of functioning, two behavioral performance tasks will~     also be presented, ie. a bag carrying task and a personalized task.~      BURDEN AND RISKS: There are no risks associated with participation to this study that are not~     otherwise related to rehabilitation and movement in general and participation is completely~     voluntary. Participants are requested to fill out questionnaires on a daily basis at home~     (computerized if possible), as well as on different time points during the study and at~     follow up and perform two behavioral performance tasks. This study could help to further~     improve the beneficial long-term effects of exposure.~   "
121960|NCT01971138|"~     This study explores the routines of registration of surgical site infections (SSI) at~     different surgical centers in Sweden. It explores the sensitivity and specificity of the~     registration routines of SSI are at Halmstad County Hospital, Sweden.~   "
121961|NCT01971125|"~     The purpose of this study is to evaluate the prevalence, during the enrolment, of Left~     Ventricular Dysfunction diastolic and/or systolic in patients with diabetes mellitus type 2~     without known or documented heart disease history and recognize its predictive clinical,~     biohumoral and with non-invasive techniques parameters.~   "
121962|NCT01971112|"~     Poor Ecuadorian older people suffer from chronic dietary deficiencies of zinc, iron, copper,~     vitamins C, B6, B12, D, and folic acid. The investigators have previously shown that these~     deficiencies are associated with impaired immune function and increased incidence of~     respiratory infections (RI). The hypothesis is that correction of these specific nutrient~     deficiencies will improve immune response and thereby enhance resistance to respiratory~     infections. To test this hypothesis this study will evaluate the effect of supplementation~     with specific vitamins and minerals found to be deficient in poor elderly Ecuadorians on~     markers of immune function and the incidence of RI. A randomized, double-blind,~     placebo-controlled trial in 320 older people (≥65 y)will be carried out in Quito, Ecuador.~     Participants will receive multivitamin and mineral supplements or placebo tablets daily for~     12 months. Nutrients will be provided at US Recommended Daily Allowance (RDA) levels, except~     for vitamin C and zinc doses, which will be 5 times and 1.25 times higher than the RDA,~     respectively. Incidence of respiratory infections (the primary outcome) will be assessed~     weekly by field nurses and physicians from the study team. Secondary outcomes include~     delayed-type hypersensitivity (DTH) skin test, cathelicidin production by mucosa respiratory~     cells, and serum C-reactive protein (CRP) as measures of immune function. Blood micronutrient~     levels and haemoglobin status will be collected as measures of adherence to the trial~     regimen. Incidence rate of RI and rate ratio (RR) will be calculated to quantify the effect~     of the intervention on the incidence of respiratory infection. This will be the first trial~     of its kind conducted specifically in a population of older people known to have poor~     micronutrient status. The findings of the study may be important for similar populations in~     other low- and middle-income countries.~   "
121963|NCT01971099|"~     Hypoactive Sexual Desire Disorder (HSDD) is the most prevalent female sexual dysfunction in~     society and is strongly linked to the quality of life of women. The androgen hormones decline~     over age in the premenopausal period, which occurs around 20 years. Tribulus terrestris is a~     plant native to India, recommended in the treatment of infertility, low libido and impotence.~     Its main active ingredient is the protodioscin, which has been attributed to an increase in~     testosterone levels and improved sexual function. The aim of this study is to evaluate the~     effects of Tribulus Terrestris in premenopausal women with HSDD.~   "
121964|NCT01971086|"~     Multi-centre, open-label, prospective, uncontrolled, single-arm, non-interventional study~     (NIS) with objective to collect and evaluate data concerning treatment with Rhinospray Plus~     in everyday curative routine treatment of acute rhinitis~   "
121965|NCT01971073|"~     A deficit in cognitive suppression is a trait of patients with schizophrenia. Cognitive~     suppression is the ability to control or suppress irrelevant responses and to adopt relevant~     responses instead. The purpose of this study is to investigate the effects of transcranial~     direct current stimulation (tDCS) on information suppression in schizophrenic patients. This~     is a noninvasive technique of brain stimulation that induces prolonged functional changes in~     the cerebral cortex through the application of a weak direct current to the scalp (Nitsche &~     Paulus, 2001). The aim of this study is to test whether bilateral tDCS over the dorsolateral~     prefrontal cortex (DLPFC) differentially modify performance on several cognitive tasks.~   "
121966|NCT01971060|"~     Premenopausal Women ages 18-42 will undergo a laparoscopic myomectomy. Prior to the~     myomectomy, adhesions will be assessed using a modified AFS scoring technique. All~     investigators will provide usual and customary care to research subjects during the first~     look laparoscopy. This includes the use of all standard practice anti-adhesive agents and~     heparinized irrigation fluids.V-Loc 180 suture will be utilized in all patients. All patients~     will then be evaluated by means of a second look laparoscopy (SLL) 6-12 weeks after the~     initial surgery and reevaluated via modified American Fertility Society scoring techniques.~     An independent reviewer will also score adhesions utilize a video recording made from the~     second look laparoscopic surgery. Patients will be contacted both 1 and 4 weeks post -op and~     assessed for complications. It is the expectation that patients will show no greater~     post-operative adhesion formation and a <1% complication rate. Time and ease of suturing will~     also be evaluated. It is expected that the V-Loc suturing technique will show significantly~     reduced suturing time, be easier to use, and will be associated with minimal adhesions.~   "
121967|NCT01971047|"~     The purpose of this study is to compare the safety and efficacy of intravenous (IV)~     administration of FDA approved regular human insulin and subcutaneous (SC) administration of~     humalog, a rapid-acting insulin analog (a synthetic insulin), for correction of hyperglycemia~     (high blood sugar) during the immediate preoperative period in patients with diabetes having~     outpatient surgery at the Emory Ambulatory Surgical Center (ASC).~      In this randomized controlled clinical trial patients with diabetes will be administered~     corrective doses of IV regular insulin or SC humalog for preoperative hyperglycemia to~     determine whether SC humalog results in improved intra and post-operative blood sugar~     control.The most common current practice at Emory University in the ambulatory surgical~     setting is IV administration of regular insulin for treatment of pre-operative hyperglycemia.~     Subjects will not be paid for their participation and will be assured of treatment for their~     hyperglycemia regardless of study participation.~   "
121968|NCT01971034|"~     In Brazil pancreatic adenocarcinoma represents 2% of tumors, and 4% mortality being an~     uncommon disease, however very aggressive.Only 20% of cases are indicated for curative~     surgery, of which only 20% are alive within 5 years. For locally, advanced or metastatic~     disease, since 1997, single chemotherapy with gemcitabine is the standard treatment for first~     line, with survival around 6 months approximately.There is no standard treatment regimen for~     second-line, however Paclitaxel demonstrated effect on second-line phase II study. Metformin~     is an oral hypoglycemic drug used for treatment of diabetes mellitus. There is a growing~     number of preclinical studies which show antitumor effect against pancreatic adenocarcinoma,~     probably due to the effect of anti-insulin growth factor (IGF-1). This study will add~     metformin to standard treatment for second line of locally advanced or metastatic pancreatic~     adenocarcinoma in ICESP previously treated with gemcitabine. The objective is to evaluate~     whether metformin improves the efficacy of the standard treatment with paclitaxel by clinical~     and radiological evaluation.~   "
121969|NCT01971021|"~     As of today there is very limited scientific knowledge in whicj of the two vascular access~     devices (PICC-line or venous ports) that offers the lowest complicationrates in~     cancerpatients. The study group wants to clearify this unsolved matter by comparing the two~     systems. Our primary endpoint is the presens of catheter related venous thrombosis. We are~     also looking at all catheter related complications and patient satisfaction.~   "
121970|NCT01971008|"~     The purpose of the present study is to determine whether the use of an abdominal binder is~     effective in the non-pharmacological management of orthostatic hypotension in patients~     suffering from Parkinson's disease~   "
121971|NCT01970995|"~     The main goal of the study is to evaluate if the ad libitum use of the THS 2.2 Menthol (mTHS~     2.2) for 5 days in confinement and after 85 days of product use in an ambulatory setting, by~     Japanese adult healthy smokers results in a reduction in the levels of biomarkers of exposure~     for selected harmful and potentially harmful smoke constituents (HPHCs) compared to smokers~     continuing smoking their own preferred brand of menthol conventional cigarette (mCC) and~     smoking abstinence (SA). Smokers who remained abstinent from SA were used as a benchmark to~     provide context to the exposure reduction.~   "
121972|NCT01970982|"~     The overall goal of the study is to evaluate if the ad libitum use of the Tobacco Heating~     System 2.2 (THS 2.2) for 5 consecutive days by adult Japanese healthy smokers affects the~     levels of biomarkers of exposure for selected harmful and potentially harmful constituents~     (HPHCs) compared to smoking conventional cigarettes (CC) and smoking abstinence (SA).~   "
122242|NCT01967446|"~     The Investigators hypothesize that functional status scores in elderly women undergoing~     surgery for pelvic organ prolapse will be lower at 6 weeks post-operatively but will have~     returned to baseline at 12 weeks post-operatively.~      The Investigators hypothesize that greater co-morbidity, frailty and worse functional status~     before surgery are associated with slower functional recovery, prolonged length of stay in a~     hospital or nursing care institution and greater post-operative complications following~     surgery for pelvic organ prolapse.~   "
121973|NCT01970969|"~     Our primary hypothesis is that a risk score comprised of approximately 10 single nucleotide~     polymorphisms (SNPs) that are associated with atrial fibrillation at the Genome Wide~     Association Study (GWAS) level is associated with the development of atrial fibrillation~     among previously undiagnosed patients at high risk for atrial fibrillation. A current example~     of these SNPs is shown in Table 1. As a secondary hypothesis, we will test the association~     between atrial fibrillation diagnosed in this study with a subset of SNPs reported to be~     associated with atrial fibrillation and with fine-mapping SNPs. We will also test the~     association between atrial fibrillation of less than and greater than 30 seconds and a panel~     of approximately 10 SNPs.~   "
121974|NCT01970943|"~     The placebo effect is a phenomenon that has experienced major advances of its understanding~     in the last decade. However, mechanisms of placebo analgesia in chronic pain patients have~     yet to be compared to healthy subjects. The investigators study aims to investigate the~     magnitude of placebo response and related opioid release in patients that suffer from~     episodic migraines as compared to healthy controls. In particular, the investigators are~     looking to map brain activity during placebo analgesia using modern brain imaging techniques~     such as functional Magnetic Resonance Imaging (fMRI) and Positron Emission Tomography (PET).~     The investigators hypothesis is that placebo response and the availability of opioid~     receptors is reduced in chronic migraine patients.~   "
121975|NCT01970930|"~     The purpose of the study is to isolate and characterize stem cells of patients with~     Polycythemia Vera (PV) and Essential Thrombocythemia (ET) to find out why these cells are not~     working the way they should be and why they seem to be sensitive to regulatory factors in the~     blood, such as clotting.~   "
121976|NCT01970917|"~     Dry eye syndrome (DES) is a common ocular disease, especially in the elderly population.~     Despite many treatment approaches, instillation of topical lubricants remains the mainstay of~     therapy. However, most of the topical lubricants available are not very well characterized~     and data about efficacy is sparse.~      The aim of the present project is to investigate the effect of topically administered Olixia~     pure® eye drops on tear film thickness in healthy subjects.~      Tear film thickness will be determined using ultra high-resolution optical coherence~     tomography (OCT). Measurements will be performed before instillation of the eye drops and~     every 10 minutes after instillation for one hour. One eye will receive Olixia pure® eye~     drops, the fellow eye will receive physiologic saline solution as placebo control. The study~     eye will be chosen randomly.~   "
121977|NCT01970904|"~     This study will explore the relationship of different DEB025 doses in combination with RBV to~     pharmacokinetic, pharmacodynamic (i.e. viral load reduction) and safety profiles in chronic~     hepatitis C GT 2 and 3 treatment naïve patients.~   "
121978|NCT01970891|"~     Potential for electrical stimulation to relieve Freezing of Gait (FOG)~   "
121979|NCT01970878|"~     This is a multi-center, randomized, double-blind, parallel group, chronic dosing,~     active-controlled, 28-week safety extension study of the two pivotal 24-week safety and~     efficacy studies (Studies PT003006 and PT003007). This study is designed to assess the~     long-term safety and tolerability of Glycopyrrolate (GP) and Formoterol Fumarate (FF)~     combination (GFF) metered dose inhaler (MDI), GP MDI, and FF MDI in subjects with moderate to~     very severe COPD over a total observation period of 52 weeks. Open-label Spiriva is included~     as an active control. To be eligible for this study, a subject must complete participation in~     Study PT003006 (NCT01854645) or Study PT003007 (NCT01854658).~   "
121980|NCT01970865|"~     Phase 1 and 2 trial to study the safety, pharmacokinetics, pharmacodynamics, patient reported~     outcomes and efficacy of PF-06463922 in ALK + advanced non-small cell lung cancer patients~     and ROS1+ advanced non small cell lung cancer patients .~   "
121981|NCT01970852|"~     The aim of this study is to evaluate the impact of an inpatient personal health record (PHR)~     portal intervention within the hospital environment. The intervention hopes to improve~     patient engagement with their care and to measure patient activation and satisfaction.~     Additional clinical measure (e.g. number of adverse events that occur during the stay,~     changes to medication orders, etc.) will also be studied. Characterization of hospital~     patient and clinician attitudes towards patient engagement will also be formalized.~   "
121982|NCT01970839|"~     There are a number of risk factors for development of chronic pain that have been evaluated~     including age, gender, type and duration of surgery, duration of pain prior to surgery and~     tourniquet application. There is some scientific evidence from animal studies demonstrating~     that prolonged tourniquet application can result in lack of oxygen supply to nerves, and~     subsequent nerve damage resulting in chronic pain. This theory has not been proven in humans.~     In this study the investigators will indirectly assess the evidence for abnormalities caused~     by tourniquet application on subjects' nerves using well established devices to determine the~     function of these nerves.~   "
121983|NCT01970826|"~     In patients that require dental implants , does performing the surgery in clean sterile field~     compared to aseptic field, produces more post-operatory complications, implant morbidity or~     patient discomfort ?~   "
121984|NCT01970813|"~     The aim of this study is to evaluate the efficacy of acupuncture and bee venom acupuncture~     (BVA) for idiopathic Parkinson's disease (IPD) through a sham-controlled trial and~     investigate whether there is sustainability of treatments effects by follow-up assessments~     after the end of the treatment.~   "
121985|NCT01970800|"~     The purpose of the study is to evaluate the predictive value of IGF-1 generation test for~     growth velocity during GH treatment for 12 months.~   "
121986|NCT01970787|"~     This is a Single-center prospective pilot trial involving up to 22 subjects. This study will~     assess the feasibility, safety, and efficacy of radiofrequency ablation (RFA) to the anal~     canal using the FDA cleared HALO Ablation System to eradicate anal HSIL lesions in~     HIV-negative subjects with intra-anal intraepithelial neoplasia (AIN). The study intervention~     will demonstrate that a reasonable proportion of subjects will be histologically cleared of~     their anal HSIL within the ETZ in a tolerable and relatively safe manner~   "
122243|NCT01967433|"~     To access the efficacy of adding diphenhydramine as adjunct to improve sedation and to reduce~     the amount of standard sedatives used during colonoscopy in patients on chronic opioids.~   "
122244|NCT01967420|"~     This study aims to look at the effectiveness of a combination of cognitive remediation and~     social cognition training to improve cognition and functioning when compared to cognitive~     remediation alone. The target population will be those who are experiencing their first~     episode of psychosis.~   "
121987|NCT01970774|"~     This study aims to investigate the benefit and feasibility of providing pharmacogenetic (PGx)~     testing as part of a standard medication therapy management (MTM) session for patients taking~     multiple medications, a high-risk population for adverse drug reactions and non-response.~     Research participants will attend two MTM sessions and undergo PGx testing to inform the MTM~     plan. Participants will also complete 2 surveys pre and post-MTM/PGx testing. Data analysis~     will assess the impact of MTM/PGx testing on recommendations for drug dosing, clinical~     outcomes, patient satisfaction, and feasibility of service delivery. Safety issues are~     minimal with the primary risks being associated with loss of confidentiality, typical~     discomfort associated with acquiring blood samples, and genetic discrimination.~   "
121988|NCT01970761|"~     Traumatic wounds inflict small- and large-fiber sensory nerve damage, causing neuropathic~     pain in scar tissue. Autologous fat grafting has been clinically shown to improve scar~     quality, but scantly study has explored its effects on pain. The aim of the study was to~     survey its effect on pain.~   "
121989|NCT01970748|"~     Randomized comparison within the endoscopic esophageal varices ligation versus non-selective~     beta-blocker in the primary prevention of esophageal variceal bleeding in patients with HCC.~   "
121990|NCT01970735|"~     The aim of the study was to compare the severity of illness between groups of patients~     (Facio-Scapulo-Humeral Dystrophy = FHSD1, FSHD2 and patients both FSHD1 and FSHD2).~      Despite advances in research on the subject, answers are still needed on these diseases.~      We also aim to determine whether the chromosomal genetic abnormality is involved in other~     diseases and the frequency of this mutation in the population of patients FSHD.~      This study will increase our knowledge of the two forms of FSHD who present a common~     pathophysiological mechanism and may occur together in the same family with a worsening of~     the clinical phenotype worsening . In addition, epigenetic differences between FSHD type 1~     and type 2 seems to have clinical consequences requiring appropriate management~   "
121991|NCT01970722|"~     This clinical trial studies the side effects and how well surgery and heated chemotherapy~     with or without non-heated chemotherapy after surgery works in treating patients with~     ovarian, fallopian tube, uterine, or peritoneal cancer. Giving a dose of heated chemotherapy~     into the abdomen during surgery that is done to remove ovarian, fallopian tube, uterine, or~     peritoneal cancer may help lower the risk of the cancer coming back. Giving unheated~     chemotherapy drugs directly into the abdomen after surgery may kill more tumor cells.~   "
121992|NCT01970709|"~     This multicenter Registry is to assess whether the use of pharmacogenomic data results in a~     meaningful change in a subject's drug or dose regimen. In addition, the Registry will~     evaluate the relationship between adverse drug reactions (ADR) and genotype and assess~     resource utilization (emergency department visits and hospitalizations) associated with ADR.~   "
121993|NCT01970696|"~     Rare tumors are understudied, yet have the potential to shed light on vast areas of cancer~     research. Ovarian sex cord-stromal tumors, rare tumors of childhood and young adulthood, have~     recently been found to be associated with a lung cancer of early childhood called~     pleuropulmonary blastoma (PPB). The cause of these ovarian tumors is unknown. DICER1~     mutations are seen in the majority of children with PPB. Research shows DICER1 mutations are~     also seen in some patients with ovarian tumors. Like PPB, ovarian stromal tumors are highly~     curable when found in early stage; however, later forms of the disease are aggressive and~     often fatal. The International Ovarian Stromal Tumor Registry collects clinical and biologic~     data to understand why these tumors occur and how to treat them. Current work involves the~     study of the role of DICER1 and miRNA expression in ovarian stromal tumors. Understanding the~     clinical history, predisposing factors and DICER1 and miRNA expression in these ovarian~     tumors of childhood will lead to targeted screening and risk stratification for~     evidence-based treatment and biologically rational therapies. These efforts will improve the~     lives of children by increasing survival and reducing late effects.~      The specific goals of the International Ovarian and Testicular Stromal Tumor Registry are:~        1. to understand risk factors by studying age, pathologic subtype, histopathologic~          features, tumor invasiveness, degree of differentiation, presence of metastasis~        2. to collect information on personal and family history in order to refine the clinical~          characteristics of patients and families with and without germline DICER1 mutations and~          other genetic predisposing factors~        3. to determine whether there is a pattern of gene expression or DNA alterations that~          correlate with predisposition to ovarian tumors, biologic behavior and clinical outcome~        4. to determine optimal screening regimens~        5. to use clinical data obtained through the Registry to refine treatment algorithms~        6. to establish a collection of annotated biology specimens (tumor tissue and germline DNA)~          for future research~   "
121994|NCT01970683|"~     The study will investigate whether probiotics given just before and shortly after major~     abdominal operation improve outcomes.~   "
121995|NCT01970670|"~     The primary objective is to determine how accurately one can estimate the size of the index~     tumor on preoperative imaging in patients with known breast cancer, using pathology as a~     reference standard. The primary endpoint, which will be measured on CEDM,and CE-MRI, is the~     maximum diameter (mm) of the index tumor.~   "
121996|NCT01970657|"~     This observational safety follow-up study enrolled subjects from the 802-247-09-032 study~     with the investigational product HP802-247 for venous leg ulcers, who received at least one~     application of HP802-247 or Vehicle (Placebo). This study is being done for the following~     purposes:~        1. to identify new adverse events,~        2. to examine ongoing adverse events not resolved in subjects who participated in the~          802-247-09-032 trial,~        3. to record wound status, and~        4. to determine if there are differences in Health Related Quality of Life (HRQoL)~          associated with the treatment assignment from the 802-247-09-032 Trial.~      About 440 subjects were to participate depending upon subject enrollment from the previous~     study, 802-247-09-032. The study was conducted in approximately 50 sites in Europe.~   "
121997|NCT01970644|"~     Cancer which spreads to the brain (brain metastases) is a common and significant problem.~     Historically, whole-brain radiotherapy has been used to treat these patients but has a~     negative effect on cognition. Radiosurgery is an alternative treatment with potential for~     fewer cognitive side effects. The impact of radiosurgery alone on the cognitive function of~     patients with multiple brain metastases is not well studied. We propose a pilot study at the~     Winnipeg Centre for Gamma Knife Surgery to examine this issue.~   "
121998|NCT01970631|"~     The objectives of this research are to conduct a proof of concept randomized controlled trial~     with 200 patients undergoing primary total knee replacement (TKR) at Brigham and Women's~     Hospital (BWH). The trial will compare levels of physical activity in subjects in the~     behavioral and economic interventions versus Usual Care post TKR.~   "
121999|NCT01970618|"~     RV1162 is a new medicine being developed for possible treatment of smoking related lung~     disease (also known as chronic obstructive pulmonary disease - COPD). The main purpose of~     this study is to investigate the safety, tolerability and pharmacokinetics of single and~     repeat doses of RV1162.~   "
122001|NCT01970592|"~     Hemiparesis, strictly defined as (muscular) weakness affecting one side of the body, is seen~     in three-quarters of individuals following stroke. Weakness in this population results from~     both neural and muscular factors which include, respectively, the ability to activate~     skeletal muscle as well as the force generating capacity of the muscle. The overall goal is~     to improve walking in persons post-stroke by training subjects with an intervention that~     specifically targets existing neural and muscular impairments, thereby facilitating locomotor~     recovery.~   "
122002|NCT01970579|"~     The aim of the study is to assess the safety and efficacy of the paclitaxelreleasing balloon~     catheter SeQuent® Please P to treat de novo and restenotic lesions in the superficial femoral~     artery and the proximal two segments of the popliteal artery with reference diameters ≥ 4mm &~     ≤ 7mm and lesion lengths ≥ 4 cm & ≤ 27 cm. It is the intention of this trial to treat~     suitable target lesions with DCB only.~   "
122003|NCT01970566|"~     Obesity is a prevalent disorder and linked with inflammation, insulin resistance,~     dyslipidemia, obstructive sleep apnea, atherosclerosis, and associated with significant~     morbidity and mortality. This randomized clinical trial will compare the effectiveness of~     Intense Exercise/Moderate Calorie Restriction (IE-MCR), Topiramate-Phentermine (TP) and~     cognitive behavioral therapy (CBT) on obesity and atherosclerosis in individuals with~     morbidly obesity. This randomized clinical trial will compare: 1) the change in fat mass and~     atherosclerosis, 2) the change in psychological and quality-of-life as well as economic~     burden in response to IE-MCR, TP and CBT, and 3) conduct exploratory mechanistic~     biomolecular, genetic and therapeutic analyses to develop intervention-specific~     individualized intervention models to improve management of morbidly obese individuals.~   "
122004|NCT01970553|"~     Phase I multicenter, open-label, clinical and pharmacokinetic study of PM01183 in combination~     with gemcitabine in non-heavily pretreated patients with selected advanced solid tumors to~     determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183 in~     combination with gemcitabine, to characterize the safety profile and feasibility of this~     combination in patients with selected advanced solid tumors, to characterize the~     pharmacokinetics (PK), to obtain preliminary information on the clinical antitumor activity~     in non-heavily pretreated selected solid tumor patients and to evaluate the pharmacogenomics~     (PGx) in tumor samples of patients exposed, in order to assess potential markers of response~     and/or resistance.~   "
122005|NCT01970540|"~     Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM01183 in Combination~     with Fixed Doxorubicin in Non- Heavily Pretreated Patients with Selected Advanced Solid~     Tumors to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183~     in combination with doxorubicin, to characterize the safety profile and feasibility of this~     combination, to characterize the pharmacokinetics (PK) of this combination, to obtain~     preliminary information on the clinical antitumor activity,to explore the feasibility, safety~     and efficacy of a potential improvable dose of this combination in selected tumor types [i.e.~     small cell lung cancer (SCLC) and endometrial cáncer] and to evaluate the pharmacogenomics~     (PGx) in tumor samples of patients exposed to PM01183 and doxorubicin at the RD in order to~     assess potential markers of response and/or resistance.~   "
122006|NCT01970527|"~     This phase II trial studies how well stereotactic body radiotherapy and ipilimumab work in~     treating patients with stage IV melanoma. Stereotactic body radiotherapy (SBRT) may be able~     to send x-rays directly to the tumor and cause less damage to normal tissue. Monoclonal~     antibodies, such as ipilimumab, target certain cells to interfere with the ability of tumor~     cells to grow and spread. Giving SBRT with ipilimumab may kill more tumor cells.~   "
122007|NCT01970514|"~     To evaluate the clinical safety and effectiveness of the ARO Spinal System and to assess~     preliminary cost/benefit analysis in patients undergoing decompression surgery for~     symptomatic lumbar disc herniations.~      The general hypothesis is that the ARO significantly improves outcomes in patients undergoing~     decompression surgery for symptomatic lumbar disc herniations.~   "
122008|NCT01970501|"~     This study is being done to compare the effects of bucindolol hydrochloride (bucindolol) to~     metoprolol succinate (Toprol-XL) on the recurrence of symptomatic atrial fibrillation/atrial~     flutter in patients with heart failure who have a specific genotype for the beta-1 adrenergic~     receptor.~   "
122009|NCT01970488|"~     The purpose of this research study is to compare the efficacy and safety of ABP 501 and~     adalimumab (HUMIRA®) in adults with plaque psoriasis.~   "
122010|NCT01970475|"~     The purpose of this study is to compare the effectiveness and safety of ABP 501 against~     adalimumab (HUMIRA®) in adults with moderate to severe rheumatoid arthritis (RA) who have an~     inadequate response to methotrexate (MTX).~   "
122011|NCT01970462|"~     This is a randomized controlled trial to determine the safety and efficacy of Sitagliptin in~     patients with stress hyperglycemia or mild diabetes following cardiac surgery. Patients will~     receive Sitagliptin or placebo. Sitagliptin may be of particular use in this patient~     population due to the effects on hepatic glucose production (a major feature of SH), safety~     (lack of contra-indications for heart failure or renal failure and no hypoglycemia), and~     tolerability. The secondary objective of this study is to determine whether the management of~     patients with persistent insulin requirements following cardiac surgery differs among~     patients with stress hyperglycemia or mild diabetes.~   "
122012|NCT01970449|"~     The purpose of this study is to test the safety and immune response to three different sets~     of HIV vaccines in healthy, HIV-uninfected adults.~   "
122024|NCT01970293|"~     The primary aims of this study are to test the hypotheses that among alcohol abusing and~     dependent jailed women returning to the community, adding an Alcoholic Anonymous (AA) linkage~     intervention will result in less alcohol use at follow-up, increased AA attendance once~     released, and decreased HIV/STI sexual risk behavior. Additionally, this study seeks to test~     the hypotheses that increased AA attendance will mediate the effect of the AA linkage~     intervention on alcohol use and that percent days abstinent will mediate the effect of the~     intervention on HIV/STI sexual risk-taking outcomes.~   "
122309|NCT01966562|"~     The PAHA study is a three-arm randomized controlled clinical trial (RCT). The aim of this RCT~     is to compare the effectiveness of the WHOLE-BODY VIBRATION (WBV) with the Multi-component~     training control group and control group (CG) for psychological well being, quality of life,~     proactive attitude and happiness in female aged subjects.~   "
122013|NCT01970436|"~     Not all pregnant women have the same risks for pregnancy complications. Women at low-risk for~     pregnancy complications may not need the same type of prenatal care. The goal of this study~     is to learn about the use of telemedicine for low-risk pregnant women and improve the~     delivery of prenatal care. Telemedicine is medical care provided using a computer or~     telephone to visit with a doctor for some medical appointments. Participating patients will~     be assigned by a computer to either standard prenatal care, or prenatal care involving a~     combination of standard prenatal visits and telemedicine visits. Both groups will have the~     same number of prenatal care visits.~      In both groups, we will ask about the patients' satisfaction with their care, the amount of~     time they spent visiting with their doctor, and information about time and their expenses. In~     the telemedicine group, we will teach how to measure blood pressure, fetal heart rate, and~     weight from home.~      The goals of this study are to: 1) assess the patient satisfaction, patient experiences and~     preferences, financial impact, clinical outcomes, and provider satisfaction of providing~     personalized prenatal care for low-risk pregnancies using telecommunication and remote~     patient care devices; and 2) measure the reliability of at-home, patient-recorded,~     computer-documented prenatal care measurements. The primary outcome is patient satisfaction~     with prenatal care after delivery.~   "
122014|NCT01970423|"~     Cardiac resynchronization therapy may reduce central sleep apnea, but there is no prospective~     randomized study so far demonstrating such an effect in patients with conventional pacemaker~     undergoing upgrading to CRT because of heart failure.~   "
122015|NCT01970410|"~     The purpose of this study is to determine if teriflunomide will be safe and effective to~     prevent relapses in patients with relapsing types of MS when switching from natalizumab to~     teriflunomide in patients at risk for PML. This is a two center interventional study of~     patients who have had 12 or more continuous infusions of natalizumab , who are anti-JCV-ab~     positive, and who had been free of clinical relapses during prior 12 months of natalizumab~     therapy who will be switching to teriflunomide.~   "
122016|NCT01970397|"~     A prospective, randomized, controlled, multi-center study of the safety and effectiveness of~     JUVEDERM® Ultra XC injectable gel versus Belotero Balance® for perioral lines~   "
122017|NCT01970384|"~     The purpose of this study is to evaluate whether transcranial direct current stimulation of~     the cerebral swallow motor cortex in addition to standard care can enhance recovery of~     swallow function in acute dysphagic stroke patients compared to sham treatment plus standard~     care.~   "
122018|NCT01970371|"~     This is a Phase 3 study containing a randomized open-label superiority cohort (Cohort 1)~     comparing the efficacy and safety of plazomicin with colistin when combined with a second~     antibiotic (either meropenem or tigecycline) in the treatment of patients with bloodstream~     infection (BSI), hospital acquired bacterial pneumonia (HABP), or ventilator-associated~     bacterial pneumonia (VABP) due to CRE. An additional cohort of patients with BSI, HABP, VABP,~     cUTI, or AP due to CRE, not eligible for inclusion in the other cohort, will be enrolled into~     a single arm (Cohort 2) and treated with plazomicin-based therapy. Therapeutic drug~     management (TDM) will be used to help ensure that plazomicin exposures lie within an~     acceptable range of the target mean steady-state area under the curve (AUC).~   "
122019|NCT01970358|"~     This research study is evaluating a new type of melanoma vaccine called Personalized~     NeoAntigen Cancer Vaccine. The purpose of this study is to determine if it is possible to~     make and administer safely a vaccine against melanoma by using information gained from~     specific characteristics of the participant's own melanoma. It is known that melanomas have~     mutations (changes in genetic material) that are specific to an individual patient and tumor.~     These mutations can cause the tumor cells to produce proteins that appear very different from~     the body's own cells. It is possible that these proteins used in a vaccine may induce strong~     immune responses, which may help the participant's body fight any tumor cells that could~     cause the melanoma to come back in the future. The study will examine the safety of the~     vaccine when given at several different time points and will examine the participant's blood~     cells for signs that the vaccine induced an immune response.~   "
122020|NCT01970345|"~     The proposed project will pilot the use of IGF-1 as a novel treatment for core symptoms of~     autism. We will use a double-blind, placebo-controlled crossover trial design in five~     children with autism to evaluate the impact of IGF-1 treatment on autism-specific impairments~     in socialization, language, and repetitive behaviors. We expect to provide evidence for the~     safety and feasibility of IGF-1 in ameliorating social withdrawal in children with Autistic~     Disorder. Further, we expect to demonstrate that IGF-1 is associated with improvement on~     secondary outcomes of social impairment, language delay, and repetitive behavior, as well as~     on functional outcomes of global severity.~   "
122021|NCT01970332|"~     Intermittent claudication afflicts 5% of the US population older than 55 years of age and~     develops along with hardening of the arteries of the legs. Claudicating patients limp and can~     only walk very short distances because their legs hurt. This protocol evaluates the~     mechanisms that may produce the leg dysfunction of claudication and its successful completion~     can ultimately produce significant new diagnostic and treatment strategies for the care of~     claudicating patients.~   "
122022|NCT01970319|"~     Patients with diabetes have a higher incidence of heart failure and worse outcomes than~     normoglycaemic subjects. Basic science research has suggested many mechanisms for this~     observation including endothelial dysfunction, abnormal calcium handling, fibrosis and~     activation of the renin-angiotensin-aldosterone system (RAAS), but clinical data are lacking.~     In this study the investigators will investigate the relationship between diabetes and heart~     failure by exploring the correlation between microvascular dysfunction and cardiac magnetic~     resonance (CMR) markers of left ventricular (LV) hypertrophy, cardiac dysfunction and~     fibrosis. The investigators also propose to see if this relationship is independent of blood~     pressure and markers of RAAS activity. This could have important clinical ramifications in~     type 2 diabetes by increasing the indications for treatment with RAAS inhibition or making a~     case for lower blood pressure targets.~   "
122023|NCT01970306|"~     The purpose of this study is to see if implanting MatriStem will lower the risk of one of the~     more common complications after stomach or esophagus surgery.~   "
122033|NCT01970176|"~     To determine the effect of 12 weeks of chronic PDEV inhibition with Tadalafil versus placebo~     on basal cardiorenal and humoral function and on the integrated cardiorenal and humoral~     response to acute sodium loading in subjects with preclinical systolic dysfunction (PSD) and~     renal (kidney) dysfunction.~   "
122025|NCT01970280|"~     The aim of the study is to evaluate the effect of Enoxaparin (LMWH) on the incidence of AV~     graft thromboses in patients on chronic hemodialysis.~      Primary efficacy end point of the study: to compare the time of onset of a new thrombotic~     event after successful angiography of the AV graft.~      Pprimary safety outcome of the study: frequency of hemorrhage. Design and methods: Following~     a first AV graft thrombosis and successful thrombolysis with angioplasty, patients on chronic~     hemodialysis will be randomized to s.c Enoxaparin (Clexane) 0.5 mg/1kg of body weight per day~     or control group (not on Clexane). Patients will be followed for a year or till next AV graft~     thrombotic occlusion, if it occurs before. In both groups we will compare time periods in~     months between first and recurrent thrombotic events of AVG by evaluation the difference~     between two sample means. Also interim analysis of AV grafts patency between the two groups~     will be evaluated at different time points: three, six and twelve months after randomization.~     Patients in both groups will receive unfractionated heparin during dialysis session to~     prevent thrombosis of extracorporeal circulation. Patients from Enoxaparin group will receive~     a half dose (500 units/hour) to prevent possible risk of bleeding during the session. Before~     randomization all patients will be evaluated for hypercoagulability state which will include:~     Factor V Laden deficiency, Anti phospholipid antibodies (APLA), Antithrombin III deficiency~     and Protein C/S deficiency.~   "
122026|NCT01970267|"~     Vitreous floaters are tiny, cloudy, clumps of cells that appear in the otherwise clear fluid~     (vitreous) that fills the back 3/4 of the eye. Floaters are commonly caused by eye conditions~     such as posterior vitreous detachment (PVD), vitreous syneresis and asteroid hyalosis. While~     these symptoms are considered physiological in nature, they can be of considerable~     inconvenience to many patients which affect essential activities. The investigators wish to~     assess the safety and efficacy of floater treatment in patients with highly symptomatic~     floaters using an FDA approved nanosecond infrared yttrium aluminum garnet (YAG) lasers.~   "
122027|NCT01970254|"~     The goal of this clinical research study is to learn about testing patients for viral~     infections before chemotherapy. Researchers want to learn which patients are at higher risk~     for these infections so that, in the future, patients might be able to be tested more~     effectively.~   "
122028|NCT01970241|"~     Despite a significant problem with out-of-control glucose levels in patients with diabetes~     receiving corticosteroids for a variety of illnesses, there are no published protocols~     addressing how to adequately treat corticosteroid-induced hyperglycemia. Investigators~     propose to test a protocol using scheduled dosing of NPH (Neutral protamine Hagedorn) insulin~     for inpatients with diabetes receiving corticosteroids. NPH insulin action is ideally timed~     to counteract corticosteroid-induced hyperglycemia, and the dose is added to the patient's~     usual insulin regimen and timed to correspond to the corticosteroid dosing regimen.~     Investigators will prospectively enroll eligible consented patients with diabetes who are~     receiving corticosteroids as part of their treatment in a large county hospital, will~     randomize them to intervention or control groups, and will monitor their glucose levels~     during their inpatient stay. The protocol will demonstrate improved control of glucose levels~     with minimal risk of hypoglycemia, and will provide a practical and readily implementable~     protocol using NPH insulin as therapy for corticosteroid-induced diabetes.~   "
122029|NCT01970228|"~     Total hip replacement is the well-established surgical method for treatment of hip~     osteoarthritis and related diseases. The outcome of the procedure is commonly satisfactory~     and most patients will not need any revision surgery. However, the procedure has its~     complications, including (1) periprosthetic infection, (2) mechanical loosening caused by~     wear particles and (3) adverse reaction caused by metal ions released from metal-on-metal~     bearing surfaces. The unsolved clinical problem is related to the differential diagnosis of~     these conditions. The purpose of this prospective clinical study is to compare the efficacy~     of two techniques of PET/CT imaging in the differential diagnosis of these complications.~     Positron Emission Tomography (PET)/Computed Tomography (CT) imaging, performed during a~     single day, will include the head-to-head comparison of 18F-Fluoro-D-Glucose (18F-FDG) PET/CT~     and 68Gallium-citrate (68Ga-citrate) PET/CT imaging.~   "
122030|NCT01970215|"~     The primary objective of this study is to evaluate the efficacy of different doses of~     TA-8995, a cholesteryl ester transfer protein (CETP) inhibitor, on the elevation of~     high-density lipoprotein cholesterol (HDL-C) and reduction of low-density lipoprotein~     cholesterol (LDL-C), alone and in combination with statin therapy.~      The secondary objectives of this study are to determine the safety and tolerability of~     TA-8995 in patients with mild dyslipidaemia.~   "
122031|NCT01970202|"~     Approximately two thirds of the adult population in developed countries is categorized as~     over-weight or obese (BMI>30). In spite of worldwide increasing awareness, obesity is a major~     health concern. In the presence of numerous diets, medical therapies, and robust research,~     bariatric surgery remains the most effective means of weight reduction in morbidly obese~     patients (BMI>40, or BMI>35 with co-morbidities). However, bariatric surgery harbors a~     relatively high risk for postoperative complications; of them, venous thromboembolic events~     (VTE) are not common, but potentially lethal. Taken together with the propensity of morbidly~     obese patients to develop VTE, perioperative thromboprophylaxis is mandatory.~      To date, low molecular weight heparins (LMWH) are most commonly used for VTE prophylaxis in~     the aforementioned population. Due to the pharmacologic properties of LMWH and the~     characteristics of surgically treated obese patients, the optimal dose that is to be utilized~     for VTE prophylaxis in this population remains unclear. Assessment of anti-FXa levels in the~     patients' plasma can be used in order to monitor LMWH activity. Levels of 0.2-0.5 U/ml have~     been proposed by some authors for VTE prophylaxis.~      Few studies have compared different dosing regimens of enoxaparin (between 30mg-60mg q/12h)~     for VTE prophylaxis in the population undergoing bariatric surgery; nevertheless, these were~     small non- randomized trials, containing numerous methodological weaknesses. Hence, the~     optimal regimen of enoxaparin to be used for the prevention of VTE in the discussed~     population remains unclear.~      The aim of the present study is to evaluate plasma levels of anti-FXa activity, comparing two~     most commonly used enoxaparin prophylactic regimens (40mg vs 60mg q/24h) in a large and~     homogenous cohort of sleeve gastrectomy patients. Although universally used by bariatric~     surgeons, the pharmacologic efficacy of these regimens has not been evaluated in patients~     undergoing bariatric surgery.~   "
122032|NCT01970189|"~     Primary immune thrombocytopenia (ITP) is an uncommon disease characterised by a low platelet~     count, which may cause the patient to have a higher risk or increased duration of bleeding.~     Individual hospitals only encounter a small number of ITP patients each year which makes it~     difficult to study this disease. By creating this disease registry, we will be able to build~     a more complete picture of ITP, including treatment practices, through collecting information~     about the condition from patients across several hospitals in several countries. Research of~     this kind will help future patients by providing doctors with information about ITP, and~     about how patients have been treated.~   "
122034|NCT01970163|"~     The study will compare treatment with DermACELL to conventional care in diabetic foot ulcers~     (DFU) and venous stasis ulcers (VSU).~   "
122047|NCT01969981|"~     This is a prospective, single center, observational study. Patients who require a Peripheral~     Inserted Central Catheters (PICC) will constitute the study population.~      The purpose of the study is to determine whether Sherlock 3CG, is adequate means for the~     total placement of PICC and confirmation of tip of PICC placement and if this method can be~     conducted safely and efficiently.~      Patients will be included during a 6-month period as well as they are ambulatory or~     hospitalized. The patient's routine care will not be modified and only PICC will be assessed~     in the present study.~      PICC placement will be performed using the Site Rite guidance and tip position will be~     confirmed using the Sherlock 3CG.~      The procedure is the same as the routine habits of the operator (nurse or anesthesiologist);~     the vascular access team already uses the previous device for CVC placement.~      Patients won't be followed up in the study.~   "
122048|NCT01969968|"~     1. To study the kinetics of release after bariatric surgery of selected polluants stored in~          adipose tissue, looking for clinical and/or predictive factors~        2. To test the hypothesis of a deleterious effect of this release on the expected~          improvement of insulin-resistance and on the liver inflammation.~        3. To determine the level of contamination of morbidly obese patients, with or without~          metabolic syndrome, compared to a control, non obese population, with special attention~          to clinical (age, gender, reproductive history, pregnancy, nursing) and biological~          parameters (insulin-resistance, inflammation).~   "
122049|NCT01969955|"~     The purpose of this study is to determine the efficacy of nab-paclitaxel monotherapy in~     previously treated advanced or metastatic squamous lung cancer.~   "
122050|NCT01969942|"~     The purpose of this study is to examine the toxicity of using allogeneic stem cell~     transplantation for treatment of subjects with relapsed or refractory Ewing Sarcoma (ES).~     Donors will consist of either Human Leukocyte Antigen identical (HLA)or 9/10 (A, B, C, DR, DQ~     [A, B, C, are Class I markers for HLA and DR and DQ are Class II markers for Matching for~     Transplant for Donors to match with recipient]) matched related or unrelated donors.~     Specifically, we will examine:~        -  The toxicity of allogeneic stem cell transplant (SCT) in this patient population, as~          related to incidence of grade 3-4 acute Graft Verse Host Disease (GVHD).~        -  The incidence of transplant related mortality at 100 days.~   "
122051|NCT01969929|"~     To compare postoperative inflammation and breakdown of blood-retinal barrier as measured by a~     laser flare-cell meter in 20G versus 23G vitrectomy.~   "
122052|NCT01969916|"~     Our hypothesis is that quantitative 3D analysis of cardiac CT images obtained during~     vasodilator stress can accurately identify patients presenting at the emergency department~     with acute chest pain due to underlying hemodynamically significant coronary stenosis, aid in~     the identification of individuals most likely to benefit from revascularization, and thus~     improve the ability to predict patient outcomes.~      Our goals are:~        1. to test the above hypothesis by comparing stress MDCT perfusion data with invasive~          fractional flow reserve (FFR) data in patients with significant stenosis who undergo~          ICA;~        2. to determine the added value of MDCT perfusion as an adjunct to CTCA for predicting~          patient outcomes.~   "
122053|NCT01969903|"~     The purpose of this study is to find out the proper amount of a drug called dexmedetomidine~     added to the local anesthetic drug called lidocaine to prolong the time and effect of pain~     relief provided for surgery.~      Dexmedetomidine (trade name Precedex) is approved by U.S. Food and Drug Administration (FDA)~     and indicated for sedation (calming effect). It has both pain relieving and calming effects~     when added to lidocaine. In the past, addition of higher amounts of dexmedetomidine to~     lidocaine decreased blood pressure and heart rate. The investigators plan to study the effect~     of lower amounts of dexmedetomidine to achieve the same level and duration of pain relief~     without reduction of blood pressure and heart rate.~   "
122054|NCT01969890|"~     The purpose of this study is to demonstrate that granulocyte colony-stimulating factor~     (G-CSF) therapy in addition to state-of-the-art treatment (pharmacological and non~     pharmacological) is safe and significantly improves clinical outcome in patients with reduced~     left ventricular ejection fraction (LVEF) (≤45%) after successful reperfusion for large~     anterior acute myocardial infarction.~   "
122055|NCT01969877|"~     The primary endpoint in this study is to investigate if there is a difference in overall~     survival in patients with locally advanced head and neck cancer, randomized to either~     radiotherapy and cetuximab or radiotherapy and cisplatin. A second randomization is performed~     in patients with T3-T4 tumors; allocated radiotherapy either 68.0 Gy or 73.1 Gy.~   "
122056|NCT01969864|"~     The purpose of this study is to determine the effect of brief organ donation video~     interventions on consent for organ donation among college and university students. Our~     hypothesis is that the organ donation video interventions will be superior to lay health~     websites for increasing organ donation consent.~   "
122057|NCT01969851|"~     SP0966 is an exploratory study to investigate safety and efficacy of Lacosamide (LCM) in~     children with epilepsy syndromes associated with generalized seizures. LCM will be added to~     current antiepileptic treatment.~   "
122058|NCT01969838|"~     This study is to determine the efficacy of momelotinib (MMB) versus ruxolitinib in~     participants with primary myelofibrosis (PMF) or post-polycythemia vera or post-essential~     thrombocythemia myelofibrosis (post-PV/ET MF) who have not yet received treatment with a~     Janus kinase inhibitor (JAK inhibitor).~      Participants will be randomized to receive either MMB or ruxolitinib for 24 weeks during a~     double-blind treatment phase, after which they will be eligible to receive open-label MMB for~     up to an additional 216 weeks. After discontinuation of study medication, assessments will~     continue for 12 additional weeks, after which participants will be contacted for survival~     follow-up approximately every 6 months for up to 5 years from the date of enrollment or until~     study termination. For those participants planning to continue treatment with MMB following~     the end of the study, the Early Study Drug Discontinuation (ESDD), 30-day, 12-Week, and~     survival follow-up visits are not required.~   "
122059|NCT01969825|"~     The purpose of this prospective, randomized study, was to determine if neck and shoulder~     massage performed within 15 minutes of semen sample collection will increase the semen~     volume, and therefore increase the total motile sperm available for insemination as a result~     of decreased stress.~   "
122060|NCT01969812|"~     The purpose of this study is to determine patient satisfaction and tolerability of the Evie®~     slow-release insemination device for US population. Additionally, to assess cramping with the~     device and to determine pregnancy rates using the slow insemination device compared to~     standard IUI.~   "
122066|NCT01969734|"~     Despite the best medical therapy many people with emphysema remain breathless and limited in~     their daily activities. In emphysema the lungs do not empty properly when the person breathes~     out. This gas trapping makes it harder to breathe. Endobronchial valve placement, a~     treatment that stops air getting into the worst affected parts of the lung and so stops them~     from trapping gas, improves lung function, breathlessness and exercise capacity in selected~     patients with severe COPD (chronic obstructive airways disease, sometimes referred to as~     emphysema). We want to see if people with less severe COPD who are very breathless can~     benefit from the same treatment. The treatment involves placing small valves into the airways~     using a fibre optic camera (a bronchoscopy). Bronchoscopy is a standard clinical procedure~     carried out in our department.~   "
122067|NCT01969721|"~     The objective of the trial is to compare the lung function profile of once daily treatment~     with tiotropium+olodaterol FDC [2.5/ 5µg and 5/ 5µg] delivered by the RESPIMAT with the lung~     function profile of twice daily treatment with fluticasone propionate+salmeterol FDC~     [250/50µg and 500/50µg] delivered by the Accuhaler® after 6 weeks of treatment.~   "
122068|NCT01969708|"~     SCORE2 is a multicenter, prospective, randomized, phase III clinical trial in which all~     participants enrolled will be followed for up to 2.5 years. SCORE2 is designed as a~     non-inferiority trial, with study eyes randomized to intravitreal bevacizumab (1.25 mg) every~     4 weeks vs. intravitreal aflibercept (2.0 mg) every 4 weeks. SCORE2 aims to determine if~     bevacizumab is non-inferior to aflibercept for the treatment of macular edema associated with~     central retinal vein occlusion (CRVO), with the primary outcome of visual acuity measured at~     Month 6.~   "
122069|NCT01969695|"~     This is a Phase 1, open-label, multicenter, extension study. Subjects with non-Hodgkin's~     lymphoma (NHL) (excluding chronic lymphocytic lymphoma [CLL], small lymphocytic lymphoma~     [SLL], and mantle cell lymphoma [MCL]) who completed a prior ABT-199 study, or were active~     and assigned to ABT-199 when the study was completed, may roll over into this extension~     study. Subjects will receive ABT-199 during this study.~   "
122070|NCT01969682|"~     This is an open-label multicenter, study to assess the pharmacokinetic interaction of~     rifampin with ABT-199 in up to 12 subjects with relapsed or refractory non-Hodgkin's~     lymphoma.~   "
122071|NCT01969669|"~     This is an open-label multicenter, study to assess the pharmacokinetic interaction of~     ketoconazole with ABT-199 in up to 12 subjects with relapsed or refractory non-Hodgkin's~     lymphoma.~   "
122072|NCT01969656|"~     Determine the safety of 2MD, a vitamin D analog, when administered orally once daily for 28~     days in healthy normal postmenopausal women.~   "
122073|NCT01969643|"~     This study will examine the safety and tolerability of SGN-LIV1A in patients with metastatic~     breast cancer. SGN-LIV1A will be given every 3 weeks alone or in combination with~     trastuzumab.~   "
122074|NCT01969630|"~     To determine in patients with symptomatic femoropopliteal lesions whether percutaneous~     revascularization with paclitaxel-eluting balloon angioplasty (PEB) and provisional nitinol~     stent is superior with respect to the 12-month incidence of restenosis compared to treatment~     with systematic paclitaxel-eluting stent (PES) angioplasty~   "
122075|NCT01969617|"~     To contribute to the understanding of the underlying neurobiological mechanism behind the~     interaction of alcohol and nalmefene~   "
122076|NCT01969604|"~     Background:~      In recent years there has been a growing interest in sedentary behaviour defined as~     activities performed in sitting or lying position during waking hours. Sedentary behaviour~     has been recognised as an independent risk factor for cardiovascular diseases and mortality.~     A few intervention studies in older sedentary people and in overweight or obese adults have~     demonstrated, that daily sitting time can be reduced through behavioural intervention.~      Patients with rheumatoid arthritis (RA) have an increased risk for cardiovascular diseases,~     partly caused by the rheumatic disease itself but also because of physical inactivity.~     Studies have documented a positive effect of increasing physical activity on pain and~     physical functioning in patients with RA. However, the studies also show, that the patients~     find it difficult to maintain the increased physical activity levels over time. Previous~     studies suggest that in promoting health among patients with mobility disability should not~     solely focus on increasing moderate to vigorous physical activity but also target reduction~     of sedentary behaviour and increase of light physical activity. In the present study we will~     focus on reduction of daily sitting time and increase of light physical activity as this~     approach may prove more feasible for patients with RA.~      Objectives and hypothesises:~      We hypothesise, that sedentary behaviour can be reduced in patients with RA through a~     behavioural lifestyle change. In addition, we hypothesize, that reduction of daily sitting~     time can have a positive effect on symptoms and general health in patients with RA.~      The primary objective of the present intervention study is to investigate the effect of a~     motivational counselling intervention on daily sitting time in adult men and women with RA.~     Furthermore we want to investigate whether a reduction in daily sitting time is related to~     reduction in pain and fatigue, reduced weight and waist circumference and improved quality of~     life, physical function and improved cardiovascular biomarker levels (cholesterol and blood~     pressure).~      Study setting and allocation:~      In total, 150 participants will be recruited from the rheumatology outpatient clinic at~     Glostrup University Hospital, Denmark. The participants will be allocated to either an~     intervention group (75) or a control group (75).~      Intervention:~      The intervention aims to support and strengthen the participants' belief in their own ability~     to reduce their daily sitting time. The intervention will include 1) three individual~     motivational counselling sessions (60-90 minutes), conducted by one of four project nurses in~     combination with 2)Individual Short Text Messages (SMS). The counselling sessions will focus~     on information about the positive health effects of reducing daily sitting time and the~     participants' own goals of reducing their sitting time. Based on the goals the participants~     will receive weekly SMS reminders.~      Data collection:~      Measurements on all participants will be done four times during 22 months; 1) at baseline, 2)~     16 weeks after start (by the end of the intervention), 3) six months after end of~     intervention and 4) 18 months after end of intervention. At each of the four visits the~     participants fill in questionnaires regarding demographics, lifestyle, daily sitting time,~     physical activity, physical function, pain , fatigue and quality of life. Furthermore, two~     occupational therapists will measure the participants' blood pressure, height, weight and~     waist circumference. At the same time a little monitor will be placed on the participants'~     thigh, which they will carry for seven days. The monitor measures the participants' physical~     activity level. The four measurements also include a blood sample from the participants in~     order to measure cholesterol levels.~   "
122077|NCT01969591|"~     To compare the outcomes of fast track laparoscopic surgery and conventional laparoscopic~     surgery.~   "
122078|NCT01969578|"~     Salivary Gland (SG) Cancers are a rare and heterogeneous group of tumors, usually approached~     by multidisciplinary teams in high specialized centers. Until today no standard of care~     exists to treat these cancers. The identification of a target, the androgen receptor, in SG~     tumors has allowed for new treatment strategies options for this rare group of diseases. As a~     matter of fact, strong positivity for androgen expression has been found in salivary duct~     carcinoma and adenocarcinomas. The purpose of this study is therefore to evaluate the~     efficacy and safety of chemotherapy versus androgen deprivation therapy (ADT) in patients~     with recurrent and/or metastatic AR expressing SGCs.~      The study will include two cohorts of patients: Cohort A, which comprises chemo-naïve~     patients, and Cohort B, which comprises pretreated patients.~   "
122079|NCT01969565|"~     The purpose of this study is to evaluate the safety and tolerability of increasing doses of~     carfilzomib in combination with dexamethasone~   "
122080|NCT01969552|"~     TSH plays a central role in current thyroid function testing both as a diagnostic tool and~     therapeutic target. Recent studies have suggested a more complex and hierarchical~     relationship between logTSH and FT4 over the entire functional spectrum than the widely~     assumed single log linear gradient (1-4). Our group has also shown a disjoint between~     pituitary TSH and FT3 serum levels being operative under conditions of levothyroxine~     monotherapy (5).~      The present prospective observational study aims at confirming some of these findings and~     exploring additional factors other than TSH that may be important in shaping the~     interrelation of thyroid parameters and modulating thyroidal activity in health and disease.~      To this purpose, unselected patients presenting for thyroid testing or treatment to a~     specialised unit at a teaching hospital will be prospectively studied to assess the interplay~     of FT3, FT4 and TSH under various conditions, and to evaluate various thyroidal and~     non-thyroidal influences, such as disease entity, thyroid volume, deiodinase activity,~     thyroid medication, surgery, radioiodine treatment, age, BMI, smoking on pituitary set-point~     and homeostatic equilibria.~   "
122081|NCT01969539|"~     The general aim of this 1-day, open label, non-randomised, trial is to characterize the~     performance of two adapter devices designed to permit use of the Respimat® inhaler with~     patients requiring mechanical ventilation.~   "
122103|NCT01969253|"~     Over the past few years, several studies have been made on various outcomes about the~     incidence of lymphedema. Because the outcomes can be came out differently each study by~     measurement, criteria, treatment period, treatment method and morbid extremities of~     lymphedema. Therefore it is required for understanding about the incidence, risk factor and~     physical progress for to be treated and prevented of lymphedema. Also it is necessary that to~     understand characteristics of lymphedema measurements and to establish diagnostic criteria of~     lymphedema through comparative study.~      The aim of this study was to analyze the incidence and risk factor of lymphedema through~     prospectively observation, and to determine effects on the quality of life of lymphedema~     after breast cancer surgery with ALND.~   "
122082|NCT01969526|"~     Objective: To evaluate the effectiveness of a multifactorial intervention program based on~     physical activity and diet, memory workshops and review of medication, to modify frailty~     parameters, muscle strength and physical and cognitive performance in people 65 years or~     older with a positive screening for frailty. Secondly, to assess changes in falls,~     hospitalizations, nutritional risk, disability and institutionalization or home-care.~      Methods: randomized clinical trial with a control group, of one year and a half of follow-up,~     conducted in eight primary care teams in Barcelona. Individuals to be included are 65 years~     or older with positive frailty screening, timed get-up-and-go between 10 to 30 seconds, and~     cognitive Lobo test greater than or equal to 18. 165 patients will be selected in each group~     (difference to be detected on physical performance (Short physical performance battery~     (SPPB)): 0.5 units; common Standard Deviation : 1.42, 20% lost to follow-up).~      Intervention: consists in three different actions on frailty dimensions, applied to each~     subject in the intervention group, in groups of 15 participants: rehabilitative therapy plus~     intake of hyperproteic shakes, memory workshop and review of the medication.~      Evaluations will be blinded and conducted at 0, 3 and 18 months. Analysis of variance for~     repeated measures to adjust for differences attributable to intervention effect and for~     potential confounders such as comorbidity, sensory limitations, social risk, other medical or~     social interventions, among others.~   "
122083|NCT01969513|"~     Vertigo is a common medical issue with a broad expectrum of diagnoses that requires a global~     approach to patients through structured clinical interview and physical examination. The main~     cause of vertigo in primary care is benign paroxysmal positional vertigo (BPPV) that is~     confirmed by a positive Dix-Hallpike positional test and treated with repositioning~     manoeuvres. Objective: To evaluate the effectiveness of Epley's manoeuvre performed by~     general practitioners (GPs) in the treatment of BPPV. Design: randomized clinical trial~     conducted in primary care. Scope: Two urban centres serving about 50,000 patients. Patients:~     All patients with newly diagnosed BPPV will be offered to participate in the study and will~     be randomly assigned to the treatment group (Epley manoeuvre) or control group (sham~     manoeuvre) and both groups will receive betahistine. Outcome variables will be: response to~     the Dix Hallpike test, patients will inform if vertigo was present during the last week~     (dichotomous variable: yes/no), intensity of vertigo symptoms on a Likert scale in the past~     week, score of Vertigo Handicap Inventory and quantity of betahistine taken. Statistical~     analysis: Descriptive statistics of all variables collected. Groups will be compared using~     the intent-to-treat approach and either parametric or nonparametric tests depending on the~     nature and distribution of the variables. Chi-square test or exact Fisher test will be used~     to compare qualitative measures and Student's t test o Mann Whitney U test will be used for~     between-group comparison of variables.~      Positive results from our study will highlight that treatment of BPPV can be performed by~     trained GPs and its widespread practice can greatly improve the quality of life of these~     patients.~   "
122084|NCT01969500|"~     The goal of the proposed project is to develop and pilot a mobile Self-Management of~     Schizophrenia (SOS) system that will administer interventions targeting persistent symptoms~     of psychosis, social dysfunction, and poor medication adherence, with the long-term goal of~     creating a widely-available system that can be deployed by users as needed, in their own~     environments. The hypothesis is that this intervention group will show stronger improvement~     in the areas of psychiatric systems, social function, and medication adherence compared to~     treatment as usual.~   "
122085|NCT01969487|"~     Surgical residents and fellows acquire operative knowledge and skills by assisting attending~     surgeons in the operating room. Previous research has shown that practising technical skills~     prior to operating on patients can improve how skillfully laparoscopic surgery can be~     performed. Although an increasingly large number of patients are undergoing robotic~     hysterectomy and other robotic surgical procedures, little is known on how to ensure patient~     safety and treatment effectiveness when trainee surgeons participate in the operating room.~     Our study aims to determine the impact of immediate preoperative warm-up on a robotic surgery~     simulator by gynecologic surgical trainees on their intraoperative performance and on patient~     outcomes. The investigators are randomly assigning gynecologic surgical trainees at a major~     academic medical center to either warm-up immediately before surgery on a robotic surgery~     simulator or to not warm-up. The attending surgeon supervising the trainee in the operating~     room is unaware of whether the trainee was assigned to warm-up or no warm-up. The~     investigators will compare standard robotic surgical skills assessments of the trainees by~     the supervising attending surgeons and patient outcomes in the two groups.~   "
122086|NCT01969474|"~     The hypothesis of the study is that the use of Cannabis will attenuate the tinnitus level as~     experienced by the patients.~   "
122087|NCT01969461|"~     Alcohol use among persons with HIV exacerbates health problems and accelerates HIV disease~     progression. Antiretroviral therapy (ART) is the single most important treatment for people~     living with HIV. However, ART adherence is suboptimal among adolescents and young adults~     living with HIV, the age group with the fastest growing rates of HIV infection, and great~     risk of engaging in risky behaviors such as alcohol use. The proposed study will compare the~     effectiveness of home-based versus clinic-based Healthy Choices, a brief, 4- session~     intervention using Motivational Enhancement Therapy (MET) to address alcohol use, medication~     adherence, and health outcomes in youth living with HIV (YLH) using a repeated measures~     design. Unlike previous trials, Healthy Choices will be tested in a real world clinical~     setting and be delivered by community health workers (CHW: already members of the HIV care~     team). The study population will consist of YLH, ages 16-24, who are current patients at 5~     ATN sites. Site staff will recruit potential participants. Youth will be randomized to~     receive Healthy Choices, either clinic-based or home-based delivered by the same CHW in both~     conditions. Outcomes are measured at baseline, 4-, 7-, and 13-months. Data collection for~     biological measures will be through medical record extraction, and self-reported measures~     will occur using a brief Web-based CASI (computer-administered self-interviewing) survey on~     an iPad. All intervention sessions will be audio-recorded for MITI fidelity coding, and~     investigators will support local supervisors during the active intervention phase. We will~     conduct qualitative interviews with CHWs, supervisors and organization leaders at the end of~     the trial to obtain information about barriers and facilitators of implementation. Thus, the~     proposed trial will allow us to use a Type 1 Effectiveness-implementation hybrid design to~     pilot a sustainable model of MI implementation in real-world youth care settings towards the~     goals of 1) examining the effectiveness, cost-effectiveness, and scalability of an~     efficacious behavioral intervention when delivered by CHWs in real-world adolescent HIV care~     settings; 2) gathering information about who responds under what contexts; and 3) increasing~     our understanding of the barriers and facilitators for future implementation. The primary~     hypothesis is that YLH receiving home-based MET will have greater improvements in alcohol use~     and viral load than YLH receiving clinic-based MET.~   "
122114|NCT01969110|"~     The purpose of this study is to investigate whether perioperative immunonutrition has~     additional effects on cell-mediated immunity in patients undergoing pancreaticoduodenectomy.~   "
122088|NCT01969448|"~     The investigators hypothesize that nipple-areola skin sparing mastectomy (NASSM) performed~     through an inframammary incision has a superior blood supply relative to a lateral oblique~     incision. Moreover, by minimizing complications and optimizing aesthetic outcomes, the~     investigators believe it will be associated with significantly higher patient reported~     outcome scores. The addition of information gained by use of intraoperative laser-assisted~     fluorescent angiography (measured with the Spy Elite imaging device) will reduce complication~     rates by directing intraoperative resection of ischemic tissue and limiting the volume of~     immediate implant placement in instances where real time imaging would suggest compromised~     perfusion. These quantifiable, objective measures will justify the use of NASSM and immediate~     implant placement coupled with intraoperative laser-assisted fluorescent angiography in~     prosthetic based breast reconstruction despite longer operative times.~   "
122089|NCT01969435|"~     Phase II study is being conducted to confirm the safety and efficacy of high-dose Melphalan~     HCl for Injection (Propylene Glycol-Free) when included in the BEAM regimen for myeloablative~     conditioning in lymphoma patients undergoing ASCT~   "
122090|NCT01969422|"~     Comparison of online question-answering system and conventional consultation for~     dermatological questions:~        -  same diagnosis?~        -  same information, which had been collected?~        -  same recommendations about treatment?~        -  what were the relevant differences of the two?~   "
122091|NCT01969409|"~     Recent research studies have suggested that proteins called antibodies that are produced by~     the immune system might be involved in the lung damage of idiopathic pulmonary fibrosis~     (IPF). Antibodies produced by the immune system normal help to fight infections by attacking~     bacteria and viruses without harming our own tissues. In patients with IPF, there is evidence~     that certain antibodies (called autoantibodies) attack the lung and contributes to the injury~     and scarring that occurs in IPF. Our recent studies have found that many IPF patients appear~     to have excessive autoantibody levels in blood and lungs that might make their disease worse.~      Rituximab is a medication approved by the Food and Drug Administration (FDA) for the~     treatment of autoantibody diseases such as rheumatoid arthritis. Rituximab works by~     destroying B cells, a type of white blood cell, called a B-lymphocyte, which produce~     autoantibodies. In this research study, rituximab will be given into a vein to reduce the~     autoantibody levels that we believe might be contributing to the lung damage in IPF.~      This study is being conducted to determine if rituximab provides beneficial effects for IPF~     patients by decreasing further lung injury.~   "
122092|NCT01969396|"~     To assess the adequacy of an endometrial biopsy sample obtained using sonohysterography.~   "
122093|NCT01969383|"~     Muscle activity in the aquatic environment was investigated while performing different~     exercises by electromyography analysis, due to conflicting results in the literature in~     relation to the floor. This study evaluated and compared the electrical activity of the~     rectus femoris and biceps femoris, in aquatic method and on the floor, during flexion and~     knee extension exercises with and without load.~   "
122094|NCT01969370|"~     This study is part of a larger consortium project investigating the validity and best use of~     next-generation sequencing (in particular, whole exome sequencing, or WES) in clinical care.~     This sub-project is investigating benefits and harms of providing WES diagnostic and~     different types of incidental findings to adult patients and parents of pediatric patients~     who undergo WES because they have symptoms suggesting genetic disease.~   "
122095|NCT01969357|"~     SP2086 is a new dipeptidy1 peptidase(DPP)-4 inhibitors. This study aims to explore the~     effective dose range of SP2086 in Patients with type 2 diabetes.~   "
122096|NCT01969344|"~     SPIROMICS was initially funded through contracts from the NIH. That phase of SPIROMICS is now~     referred to as SPIROMICS I. SPIROMICS is now funded as a grant from the NIH. The current~     phase is referred to as SPIROMICS II.~      Brief summary of SPIROMICS I:~      The purpose of SPIROMICS is to learn about chronic obstructive pulmonary disease (COPD),~     which is sometimes called emphysema or chronic bronchitis. Millions of Americans have COPD,~     and it is the fourth leading cause of death in the country. The most common cause of COPD is~     cigarette smoking, although not all smokers get COPD. The discovery of new treatments for~     COPD has been slowed by a poor understanding of different types of COPD and a lack of ways to~     measure whether or not COPD is getting worse.~      The study has two main goals. The first is to find groups of patients with COPD who share~     certain characteristics. Certain groups may respond differently to certain treatments. The~     second is to find new ways of measuring whether or not COPD is getting worse. This would~     provide new ways of testing whether a new treatment is working.~      SPIROMICS has three substudies and two ancillary studies.~      Substudies:~        1. Repeatability Substudy: The entire baseline clinic visit will be repeated on 100~          volunteers. The goal of this substudy is to determine reliability of measurement~          procedures.~        2. Bronchoscopy Substudy: 300 participants will be enrolled for two additional study~          visits, including a bronchoscopy. The goal of this substudy is to collect and assess~          biological specimens and relate those results to clinical measurements.~        3. Exacerbation Substudy: Up to 400 participants will be enrolled in this substudy. A daily~          symptom diary will be collected on all participants. Participants will also be seen in~          the clinic during a pulmonary exacerbation. The goals of this substudy are to 1) better~          understand the relationship between symptoms and exacerbations and 2) obtain clinical~          data and specimens during a pulmonary exacerbation.~      Ancillary Studies:~        1. Air Pollution Ancillary Study: The SPIROMICS Air Pollution ancillary study uses~          state-of-the art air pollution exposure assessments to determine individual-level~          outdoor and indoor air pollution exposure. The goals of this substudy are to determine~          the effect of long-term air pollution exposure on COPD morbidity and to determine~          whether short-term changes in outdoor air pollution are associated with changes in COPD~          morbidity.~        2. Parametric Response Mapping in COPD: The Parametric Response Mapping (PRM) in COPD~          ancillary study collects an additional CT scan during the final study visit and uses a~          new analysis technique (PRM) to assess the functional small airways of the lung and~          emphysema.~      Brief summary of SPIROMICS II:~      Aim 1 is to define the natural history of Smokers with symptoms despite preserved~     spirometry and characterize the airway mucus abnormalities underlying this condition. Aim 2~     is to determine the radiographic precursor lesion(s) for emphysema, and identify the~     molecular phenotypes underlying airway disease and emphysema. Aim 3 is to advance~     understanding of the biology of COPD exacerbations through analysis of predisposing baseline~     phenotypes, exacerbation triggers and host inflammatory response.~      SPIROMICS II will continue follow-up of current participants, with no new enrollment. Each~     participant will have one clinic visit and will be contacted by telephone every 4 months.~   "
122097|NCT01969331|"~     The aim of the study is to establish efficacy and safety of Normia® probiotic, used as an~     add-on therapy in treatment of H. Pylori infection with the standard triple therapy approach.~      The primary objective in the study is determination of efficacy of Normia® probiotic as a~     supportive therapy in achieving a higher percentage of eradication of H. Pylori.~      The secondary objectives are to assess:~        -  Safety profile of Normia® probiotic in everyday use, e.g. reduction in number of~          side-effects and better compliance to the eradication therapy~        -  Safety and efficacy of Normia® probiotic in different demographic subgroups~   "
122098|NCT01969318|"~     SP2086 is a new dipeptidyl peptidase(DPP)-4 inhibitor. This study aims to evaluate the~     efficacy and safety of SP2086 in combination therapy with Metformin in patients with Type 2~     Diabetes in Metformin monotherapy Who have Inadequate Glycemic Control~   "
122099|NCT01969305|"~     This pilot study will adapt and test the feasibility and estimate the effect size parameters~     of Kazakhstani Family Together (KFT), a family-based multi-media intervention designed to~     reduce sexual and drug-related risks for HIV infection among at-risk 14-17 year old females~     and males living in communities highly affected by heroin trade and use in Almaty,~     Kazakhstan.~   "
122100|NCT01969292|"~     Our team has created an automated, real-time software based image analysis tool called~     Colometer to improve screening colonoscopy providing real time visual feedback on image~     quality. There are three components to this study. The first is to validate the bowel~     assessment preparation using the recorded colonoscopy videos from 50 consented normal risk~     patients. In the second phase, technological and machine user interface refinements will be~     identified and completed. Finally, the third phase will be a sham controlled prospective~     study of Colometer versus standard care in 100 consented average risk patients undergoing~     screening colonoscopy as performed by 10 consented endoscopists.~   "
122101|NCT01969279|"~     Although there is strong evidence that bisphosphonates prevent certain types of osteoporotic~     fractures, there are concerns that these medications may be associated with rare atypical~     femoral fractures (AFF). But the relationship between long-term bisphosphonate treatment and~     AFF is unclear. In this study, the investigators would like to analyze the long term effects~     on femur by bisphosphonate treatment.The participants are treated in the investigators~     hospital more than four years.~   "
122102|NCT01969266|"~     The purpose of this study is to examine the exposure and safety of a supratherapeutic dose of~     PCI-32765 (ibrutinib) in healthy adult volunteers.~   "
122310|NCT01966549|"~     The purpose of the study is to evaluate the effect of CNTO6785 compared with placebo in~     participants with moderate to severe Chronic Obstructive Pulmonary Disease.~   "
122104|NCT01969240|"~     Our long-term goal is to promote evidence-based patient-centered evaluation in the acute~     setting to more closely tailor testing to disease risk. To compare the use of risk~     stratification tools with usual clinical approaches to treatment selection or administration,~     we propose the following:~        1. Test if Chest Pain Choice safely improves validated patient-centered outcome measures in~          a pragmatic parallel patient randomized trial.~           Hypothesis: The intervention will significantly increase patient knowledge, engagement,~          and satisfaction with no increase in adverse events.~        2. Test if the decision aid has an effect on healthcare utilization within 30 days after~          enrollment.~      Hypothesis: The intervention will significantly reduce the rate of hospital admission, rate~     of cardiac testing, and total healthcare utilization.~   "
122105|NCT01969227|"~     Maintaining the patency of upper airway in sedated and anesthetized patients is challenging~     especially when patients are ready to be weaned from mechanical ventilation. Impairment of~     airway patency is a common cause of extubation failure and opioids and hypnotics can~     adversely affect airway patency.~      Ketamine, a noncompetitive antagonist of N-methyl-D- aspartate (NMDA), unlike other~     anesthetics activates respiratory effort and promotes bronchodilation. At subanesthetic~     plasma concentration, ketamine reduces both opioid and propofol requirements. Recent animal~     data suggests that when added to propofol in a sedation regimen, ketamine decreased~     hypoventilation when compared to propofol alone because ketamine can increase genioglossus~     phasic activity while abolishing the coupling between loss of consciousness and upper airway~     dilator muscle activity. However, this relationship has not been examined in human in~     combination of other drugs.~      The purpose of this pharmaco-physiological interaction trial is to evaluate the effects of~     ketamine on breathing and electroencephalography in mechanical ventilated patients.~     Spirometry will be utilized to evaluate upper airway patency. Polysomnography (PSG- Alice~     PDx) will be used to evaluate the effects of ketamine on EEG during wakefulness and sleep. An~     esophageal balloon will be inserted to measure esophageal pressure, which enables us to~     measure the effects of ketamine on transpulmonary pressure. A volumetric capnography, NICO~     noninvasive device from Respironics will be used to measure anatomical dead space, CO2~     production, mean expiratory CO2 and slope of the alveolar plateau of the volumetric capnogram~   "
122106|NCT01969214|"~     Diosmectite in IQP-MM-101 has been used for diarrhoea control. Backed by data from several~     studies demonstrating their efficacy, the investigators are conducting this study to look~     into the efficacy and safety of IQP-MM-101 in diarrhoea control.~   "
122107|NCT01969201|"~     The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety~     of two different subcutaneous FSH preparations (Fostimon versus Gonal-F) for controlled~     ovarian hyperstimulation in a GnRH-antagonist cycle.~   "
122108|NCT01969188|"~     Spondyloarthritis refers to a set of inflammatory disorders that mainly afflict the spine,~     joints and ligaments. A subtype of spondyloarthritis is Ankylosing Spondylitis - now known as~     axial spondyloarthropathy - which is characterized by inflammation of the joints in the~     spinal column, and the part of the back where the spine meets the pelvis. Another subtype of~     spondyloarthritis is Psoriatic Arthritis where patients often develop raised patches of~     reddened skin. The disease can advance to one of more joints in the body resulting in pain,~     swelling and stiffness. These forms of inflammatory arthritis can become chronic and over~     time can lead to pain, disability and deformity.~      There is now evidence that patients with inflammatory arthritis that are diagnosed and~     treated earlier in the course of their symptoms may have better results. Yet although we know~     that early treatment is important, the investigators still don't know if there are factors~     that can predict how an individual patient's disease will progress over time in terms of~     losing mobility. The investigators also do not know the relationship between loosing mobility~     and the formation of bone around the spine and joints.~      The investigators are doing this study because the investigators want to learn more about~     patients with these forms of arthritis - Ankylosing Spondylitis and Psoriatic Arthritis. The~     investigators want to learn more about the factors that can predict how their disease might~     progress over time and what their response to treatment might be. The investigators would~     also like to determine the proportion of patients with these types of symptoms and describe~     the best treatment strategies for them.~   "
122109|NCT01969175|"~     The objective of this study is to assess the effect of a low-glycemic-load and milk-free diet~     on acne severity.~      IGF-1 and a phosphorylated product of the mTORC pathway (p70S6K) will be assessed in both~     groups to explore the mTORC signaling pathway, which is thought to be related to clinical~     improvement in previous studies.~   "
122110|NCT01969162|"~     This exploratory study will collect tear samples from adult volunteers for determining and~     quantifying tear composition profiles. No investigational drug will be administered in this~     study.~   "
122111|NCT01969149|"~     Stress hyperglycemia is a common phenomenon in cardiac surgery that concerns diabetic and non~     diabetic patients.~      It has been shown that perioperative hyperglycemia is an independent risk factor of~     postoperative mortality and morbidity.~      The Leuven et al.'s study suggested that strict glycemic perioperative control using an~     intensive insulin therapy could reduce mortality and morbidity in surgical intensive care's~     patients. This study included a majority of cardiac surgery patients. Others studies have~     suggested that the beneficial effect of insulin-based tight perioperative glycemic control~     might be hampered by iatrogenic hypoglycemia. Moreover, insulin therapy failed to obtain~     perioperative glycemic stability in most patients.~      Exenatide (Byetta ®) is an incretin mimetic, characterized by an anti-hyperglycemic effect~     that depends on the blood glucose level.~      We hypothesize that continuous intravenous infusion of exenatide could improve perioperative~     glycemic control and stability and could reduce the risk of iatrogenic hypoglycemia compared~     to a conventional insulin therapy during the perioperative period of cardiac surgery.~   "
122112|NCT01969136|"~     The purpose of this study is to evaluate the safety and efficacy of 2 fixed doses of EVP-6124~     compared to placebo for 26 weeks in subjects with mild to moderate Alzheimer's disease~     currently receiving stable treatment or previously treated with an acetylcholinesterase~     inhibitor.~   "
122113|NCT01969123|"~     The purpose of this study is to evaluate the safety and efficacy of 2 fixed doses of EVP-6124~     compared to placebo for 26 weeks in subjects with mild to moderate Alzheimer's disease~     currently receiving stable treatment or previously treated with an acetylcholinesterase~     inhibitor.~   "
122115|NCT01969097|"~     The aim of the study is to investigate whether the combination of bihemispheric (dual)~     transcranial direct current stimulation (tDCS) and motor training on 5 consecutive days~     facilitates motor recovery in chronic stroke. Results will be compared to a matched group of~     patients undergoing anodal tDCS as well as a control group receiving sham tDCS. Functional~     and structural magnetic resonance imaging (MRI) before/after the intervention and during a 3~     month follow-up will help investigating neural correlates of expected changes in motor~     function of the affected upper extremity.~   "
122116|NCT01969084|"~     Investigators propose to examine the effect of 12 weeks of Linagliptin, a diabetes drug,~     treatment on inflammation as well as vascular and mitochondrial function in diabetic~     patients. Investigators hypothesize that Linagliptin will reduce the proinflammatory state,~     improve endothelial function, increase the blood flow at the muscle microcirculation level~     and improve mitochondrial function. In this study, investigators will perform tests that~     evaluate the function of small and large blood vessels by employing ultrasound and laser~     doppler techniques. In addition MRI scans that evaluate the mitochondrial function of the~     lower extremity muscles at rest and during exercise will also be employed. Forty subjects~     with Type 2 diabetes will be studied for twelve weeks and half of them will be randomly~     assigned to receive linagliptin while the other half will receive placebo. All tests will be~     performed at the beginning and the end of the study.~   "
122117|NCT01969071|"~     The effects of levosimendan on renal function in patients with low ejection fraction~     undergoing mitral valve surgery will be investigated in a prospective, double-blinded,~     randomized clinical trial using serum creatinine (sCr)milligram in deciliter (mg/dL) values,~     calculated estimated glomerular filtration(eGFR)(ml/min/1.73 m2) rates and perioperative~     clinical follow-up parameters.~   "
122118|NCT01969058|"~     This phase II study was done in HIV-infected participants on antiretroviral therapy to~     evaluate the effects of isotretinoin (a drug that is approved for use in the treatment of~     severe acne) on the immune system. The immune system helps the body fight infections. When~     the immune system is not working well, one may be at greater risk for diseases that are~     common in aging, like heart disease, weaker bones, and kidney disease.~   "
122119|NCT01969045|"~     The aim of this prospective study is to examine the benefits und risks of administration of~     local anaesthetics with a special atomizing set (Enk Fiberoptic Atomizer, Cook Medical)~     during flexible bronchoscopy.~   "
122120|NCT01969032|"~     The purpose of this study is to increase survival of patients with locally advanced~     triple-negative breast cancer using two consequent induction preoperative chemotherapy~     regimens.~   "
122121|NCT01969019|"~     This study was designed to compare the efficacy and safety of 4.5g iv MP administered in 12~     weeks and 4 weeks.~   "
122122|NCT01969006|"~     This study is undertaken to clarify whether intraoperative blockage with 40 ml of ½ %~     Marcaine© of the nerves in the ilio-inguinal canal may decrease postoperative pain after~     laparoscopic inguinal hernia repair.~      Patients will be randomised to injection of Marcaine© og a needle prick per-operatively.~      Pain will be estimated using the VAS score in:~      1. the wound 2 the abdomen 3 the shoulder~      Scoring will be performed:~        1. pre-operatively~        2. 1 hour postoperatively~        3. at discharge from the hospital d day 1,2 and 3 post OP~      e. 1 year post OP~   "
122123|NCT01968993|"~     nanOss Bioactive is approved for use in the U.S. The purpose of this study is to compare~     fusion results in the posterolateral spine using nanOss Bioactive mixed with autograft bone~     and bone marrow aspirate (BMA) on one side and autograft alone on the opposite side of the~     treated level(s). It is hypothesized that the use of nanOss Bioactive will result in fusion~     at 12 months, with CT evidence of bridging trabecular bone, less than 3mm of translational~     motion, and less than 5 degrees of angular motion.~   "
122124|NCT01968980|"~     This is a multicenter, randomized study in subjects with heterozygous familial~     hypercholesterolemia receiving highly effective statins to assess the safety, efficacy and~     tolerability of Bococizumab (PF-04950615; RN316) to lower LDL-C.~   "
122125|NCT01968967|"~     This study is a multicenter, randomized study in subjects with high cholesterol receiving~     highly effective statins to assess the efficacy, safety and tolerability of Bococizumab~     (PF-04950615;RN316) to lower LDL-C.~   "
122126|NCT01968954|"~     This study is a multicenter, randomized study in subjects with high cholesterol receiving~     highly effective statins to assess the efficacy, safety and tolerability of Bococizumab~     (PF-04950615;RN316) to lower LDL-C.~   "
122127|NCT01968941|"~     A multi-centre randomized controlled open-label trial in medically inoperable patients with~     biopsy-proven early stage non-small cell lung cancer (NSCLC). Eligible and consenting~     patients will be randomly allocated to receive stereotactic body radiotherapy (SBRT) or~     conventional radiotherapy (CRT) in a 2:1 ratio. Radiotherapy will be administered as soon as~     possible following randomization and subjects will be followed for 5 years post-randomization~     for cancer recurrence, toxicity and survival. The primary outcome is local control (LC). The~     trial will be conducted at 16-20 clinical centres throughout Canada.~   "
122128|NCT01968928|"~     Bladder urothelial carcinoma (UC) is a common malignancy and the incidence is increasing by~     years in Taiwan. Chemoresistance was inevitable in treatment of metastatic disease and lead~     to the ominous outcomes. To develop novel therapeutic strategies to overcome chemoresistance~     is imperative. Cancer cells uptake glucose at higher rates than normal tissue but use most of~     glucose for glycolysis even under normoxia condition, which is known as the Warburg effect.~     Pyruvate kinase (PK) catalyzes the last step in the process of glycolysis, and one of it~     isoform--PKM2 has been reported to be associated with tumor progression and some specific~     tissues and promotes the Warburg effect in cancer cells.~   "
122129|NCT01968915|"~     This study will evaluate safety and tolerability to estimate the maximum tolerated dose~     and/or recommended dose of oral LCL161 in Japanese patients with advanced solid tumors.~   "
122130|NCT01968902|"~     The purpose of this study is to determine if Xeomin® will prove effective for significantly~     improving lower extremity spasticity and will be well tolerated by the majority of MS~     patients.~   "
122345|NCT01966081|"~     The aim of the study is to establish the existence of a relationship between the dietary~     intake of polyunsaturated fatty acids (PUFA) and the risk of colorectal cancer in humans,~     using 2 reliable and complementary biomarkers: the fatty acid-composition of lipids of the~     abdominal subcutaneous adipose tissue and the fatty acid composition of erythrocyte~     phospholipids.~   "
122131|NCT01968889|"~     Critical illness neuromyopathy is a common disease acquired during ICU stay leading to a deep~     weakness involving the respiratory muscle work which result in a delayed weaning of~     mechanical ventilation.~      The main objective is to quantify the loss of diaphragm function by measuring the diaphragm~     force (using the non invasive method by phrenic nerve stimulation allowing to measure the~     twitch airway pressure during airway occlusion) in a selected population of patients with~     critical illness neuromyopathy (defined as a MRC score < 48).~      The second end points are to evaluate its incidence, the consequences on the patients outcome~     (extubation success or failure; ICU stay) and to evaluate the relations between diaphragm~     function (twitch airway pressure during airway occlusion, maximal inspiratory pressure and~     diaphragm thickness evaluated by ultrasound) and peripheral limbs force (evaluated by the~     Medical Research Council - MRC score).~   "
122132|NCT01968876|"~     This research will act as a pilot study that will be conducted to determine the effectiveness~     of a smartphone medication adherence application on adherence to oral hypertensive, diabetic,~     and dyslipidemic medications using a prospective randomized design. Subjects will be~     recruited from the University of Arkansas for Medical Sciences (UAMS) Internal Medicine~     Clinic North, and the study data will be collected using only subject self-reports and~     subject pharmacy records.~   "
122133|NCT01968863|"~     The overall objective of this exploratory, laboratory study is to evaluate whether~     noninvasive fluorescence microendoscopic imaging of tissue can assist clinicians in detecting~     dysplastic (precancerous) areas during standard surveillance. This is a study designed to~     evaluate the feasibility of using prototype imaging technology to enhance the detection of~     precancerous changes in various tissues. The results of this laboratory study will be used to~     further develop the technology for clinical application.~      The primary aim of this project will be to investigate what digital image analysis criteria~     can be used to best detect dysplasia in various types of resected tissue.~   "
122134|NCT01968850|"~     This is a two-site, three-arm, open-label, pilot randomized controlled trial of bone~     anti-resorptive therapy during ART initiation in HIV-infected adults. Thirty (30)~     treatment-naïve HIV-infected adults initiating eligible first-line ART regimens will be~     randomized in a 1:1:1 fashion to one of the following three arms:~        1. no bone anti-resorptive therapy (standard of care)~        2. concomitant initiation of a 24 week course of co-formulated alendronate/vitamin D;~        3. a 24 week delay in initiation of a 24 week course of alendronate/vitamin D~      Assessments (including clinical evaluation, questionnaires, adherence, basic laboratory~     evaluation, and BMD measurement) will be performed at baseline, 24 and 48 weeks. The primary~     objective will involve calculation of σ and ρ using all data; δ will be estimated by~     comparing the two alendronate arms pooled to the no-treatment arm.~   "
122135|NCT01968837|"~     Although highly curable, cervical cancer kills thousands of women in developing countries~     annually. The investigators will pilot a project to improve detection of cervical cancer in~     Kilimanjaro, Tanzania through a program that combines access to cervical screening expertise~     available in a large medical centre and remote use of a mobile phone camera application.~   "
122136|NCT01968824|"~     Despite the plethora of literature suggesting that regional blockade provides adequate~     andimproved postoperative pain control, function and improved intraoperative and~     postoperative safety in proximal upper extremity surgery, little is known of its benefits for~     the treatment of forearm and distal radius fractures . The purpose of this randomized,~     prospective, study is to determine if brachial plexus blockade with general anesthesia is~     superior to general anesthesia alone in immediate and long-term pain control in patients~     undergoing operative fixation of distal upper extremity fractures.~   "
122137|NCT01968811|"~     The investigation is a Post Marketing Follow-Up Study for the Avance Foam Abdominal Dressing~     Kit conducted as part of Mölnlycke Health Care's quality system. The primary objective is to~     evaluate the dressing kit as part of a negative pressure system. The secondary objectives are~     to collect and evaluate safety data, performance data and information on technical~     complications.~   "
122138|NCT01968798|"~     The ASPREE Cancer Endpoint Study (ACES), an ancillary study of the ASPirin in the Prevention~     of Events in the Elderly (ASPREE) Study, will allow for the examination of the effect of~     daily low-dose aspirin (100 mg) compared to placebo, on specific DNA biomarkers and selected~     specific incident and recurrent cancer and metastases. The establishment of this ACES biobank~     will allow for the exploration of DNA-related molecular mechanisms of aspirin's protective~     effect against cancer, cancer associated mortality and metastases, using blood or saliva DNA~     specimens, urine, and tumor tissue.~   "
122139|NCT01968785|"~     The kidneys are an important regulator of blood pressure. Previous research has shown that~     disrupting the nerves (denervate) of the kidney may successfully decrease blood pressure. In~     the past, one technique that was used to treat severe high blood pressure was a surgical~     procedure to cut these nerves. However, this surgery is no longer commonly performed.~      Another approach to disrupting these nerves is to use the Beta-Cath 3.5F system to deliver a~     small amount of radiation to the treatment zone. The Beta-Cath 3.5F System (Novoste) is~     currently approved in the United States to deliver ion dose therapy to re-narrowings that~     form in the coronary arteries in the heart. This trial is assessing the safety of treating~     patients with the Beta-Cath 3.5F System (Novoste) to denervate the nerves around the kidney~     to help control blood pressure in patients with uncontrolled hypertension.~        1. Renal artery brachytherapy with beta-emitting source is safe.~        2. Renal artery brachytherapy with beta-emitting source can reduce systolic/diastolic blood~          pressure via renal denervation mechanism within 6 months post treatment.~   "
122140|NCT01968772|"~     In this pilot study we propose to gather preliminary data on whether transdermal magnesium~     chloride can improve quality of life in patients with fibromyalgia. Forty women with~     fibromyalgia will be enrolled in this study. Participants will be asked to apply a topical~     solution of magnesium chloride on their extremities 3 times daily for 28 consecutive days.~     Three questionnaires measuring quality of life will be administered at baseline, at 2 weeks,~     and at 4 weeks (end of study).~   "
122354|NCT01965964|"~     Translation of a validated questionnaire (SSQ) from english to german and validation of the~     german version. The SSQ consists of 17 well-structured questions for the assessment and~     quantification of patient reported difficulties in swallowing function. The tool is~     specifically designed to evaluate important aspects of swallowing function The questions~     cover the symptoms related to combinations of variables like the anatomic region, type of~     dysfunction, and the consistency of swallowed bolus.~   "
122141|NCT01968759|"~     Progressive renal impairment in chronic kidney diseases (CKD) may cause inability to excrete~     phosphate load, thus leading to the typical abnormalities of the mineral metabolism, such as~     increased phosphate and reduced calcium levels, 1,25- dihydroxyvitamin D deficiency and~     secondary hyperparathyroidism (HPT). Treatment with vitamin D analogues and/or phosphate~     binders ameliorates these abnormalities that are also associated with accelerated renal~     disease progression and increased cardiovascular risk. However in a post-hoc analysis of 331~     patients with proteinuric chronic nephropathies included in the Ramipril Efficacy In~     Nephropathy (REIN) trial, increasing serum phosphate levels at inclusion, even within the~     normal reference range, were associated with an incremental risk of progression to End Stage~     Renal Disease (ESRD). Moreover, increasing levels of serum phosphate were associated with a~     progressively decreasing protective effect of ramipril therapy against progression to ESRD,~     to the point that the benefit of Angiotensin-Converting-Enzyme (ACE) inhibition was almost~     fully lost among patients with serum phosphate levels exceeding 4.5 mg/dL. This finding~     provided convincing evidence that phosphate plays a direct pathogenic role in patients with~     progressive nephropathies and that excess phosphate exposure may limit or even blunt the~     renoprotective effect of ACE inhibitor therapy in this population.~      Sevelamer carbonate is a newly approved phosphate binder for chronic kidney disease (CKD)~     patients not yet on maintenance dialysis. Treatment with Sevelamer, in addition to correct~     hyperphosphatemia, was also found to ameliorate abnormalities of the mineral metabolism~     associated with accelerated renal disease progression and increased cardiovascular risk.~     Moreover, Sevelamer therapy reduces proteinuria in an animal model of uremia, an effect that~     in the long term might translate into significant renoprotection. These findings suggest that~     serum phosphate might be a specific target for renoprotective therapy in CKD patients and~     provide the background for randomized clinical trials to formally test whether reducing~     phosphate exposure by phosphate binding agents may serve to optimize the renoprotective~     effect of RAS inhibition in this population. Thus, whether phosphate reduction by Sevelamer~     carbonate therapy may have a specific antiproteinuric effect in humans with chronic~     nephropathies and residual proteinuria despite optimized RAS inhibitor therapy is worth~     investigating.~   "
122142|NCT01968746|"~     The overall objective of this study is to utilize heart rate variability and respiratory rate~     variability in patients with sepsis to predict clinical deterioration and death.~      Our specific objectives are:~        1. To study the ability of a change in composite variability (∆CVI) assessment to act as a~          prognostic aid in predicting disease progression in sepsis.~        2. To study the effect that standard resuscitation interventions will have on the direction~          and magnitude of ∆CVI in patients with sepsis.~      B. Hypotheses H1: In the initial resuscitation of sepsis, a low or declining multi-parameter~     composite variability index (CVI) over 4 hours will predict a significant increase in the~     combined outcome of overt shock, organ dysfunction, and mortality.~      H2: In the initial resuscitation of sepsis, low volume fluid resuscitation (<20 cc/kg) over 4~     hours will be associated with a low or declining CVI.~   "
122143|NCT01968733|"~     This study will evaluate the safety and efficacy of an experimental antibiotic,~     solithromycin, in the treatment of adult patients with community-acquired pneumonia.~   "
122144|NCT01968720|"~     The purpose of this study is to determine the safety and efficacy of multiple doses of~     CAT-2003 in patients with severe hypertriglyceridemia either naive or refractory to current~     therapy. The study will evaluate effects of CAT-2003 on fasting and postprandial total~     triglycerides and chylomicron triglyceride levels in patients with severe~     hypertriglyceridemia.~      This is a single-blind study. All patients will receive placebo for a 14 day treatment period~     and CAT-2003 for a 28 day treatment period.~   "
122145|NCT01968707|"~     The purpose of this study is to determine the antimicrobial efficacy of the 3M CHG/IPA Prep~     on skin flora of the abdomen and inguinal regions of human subjects.~   "
122146|NCT01968694|"~     We are doing this research study to find out if intravenous (in your vein, IV) lidocaine~     can lessen pain from endometriosis. The U.S. Food and Drug Administration (FDA) has approved~     intravenous lidocaine to treat irregular heart beats, but the FDA has not approved~     intravenous lidocaine to treat pain from endometriosis. Intravenous lidocaine has been used~     for more than 25 years to treat different acute and chronic pain conditions but has not yet~     been studied for endometriosis pain.~      This is a cross-over trial over two months where one month you will receive the active~     medication (lidocaine) and one month you will receive the active placebo (diphenhydramine,~     commonly known as benadryl). We will compare the effect on pain from endometriosis of~     lidocaine to active placebo.~   "
122147|NCT01968681|"~     Nevus flammeus is a congenital vascular malformation. Nevus flammeus is traditionally treated~     with pulsed dye lasers (PDL); however, around 20 percent of patients are poor responders and~     do not get satisfactory results from pulsed dye laser treatments.~      Small studies with alexandrite lasers indicate that this may be an alternative treatment for~     individuals with nevus flammeus. This study assesses the clinical effect and side effects of~     alexandrite laser treatment for nevus flammeus using different treatment settings.~   "
122148|NCT01968668|"~     This study will be conducted in Japanese subjects with type 2 diabetes mellitus and the~     clinical diagnosis of Diabetic Nephropathy( DN) using a multi-center, randomized, adaptive,~     double-blind, placebo-controlled, parallel-group design.~      Primary objective of the study is investigate the change of Urinary Albumin to Creatine Ratio~     (UACR) after treatment with different oral doses of BAY94-8862 given once daily from baseline~     to Visit 8 (Day 90)~   "
122149|NCT01968655|"~     To provide emergency access to OBI-1 for patients with Acquired Hemophilia and a serious~     bleeding episode who do not have access to an active clinical study site associated with the~     OBI-1-301 study.~   "
122150|NCT01968642|"~     The utilization of transthoracic echocardiography in the United States has been increasing.~     This has resulted in increased costs to the healthcare system. In an effort to curb excessive~     utilization of this technology, the American College of Cardiology created Appropriate Use~     Criteria to help guide clinicians to use this diagnostic imaging modality more appropriately.~     The investigators previously showed that an educational intervention can reduce the rate of~     inappropriate echocardiograms ordered by physicians-in-training. It is unknown if such an~     intervention would be successful in attending, staff level of physicians. The investigators~     hypothesize that an educational and feedback intervention will reduce the rate of~     inappropriate outpatient transthoracic echocardiograms ordered by staff cardiologists and~     internal medicine physicians.~   "
122151|NCT01968629|"~     In this research study, the investigators are looking to see if MR imaging with Eovist~     performed 24 hours after the injection of Eovist helps improve the identification and~     characterization of focal liver tumors.~   "
122152|NCT01968616|"~     In retinal vein occlusion, predictive factors for visual outcome after ranibizumab treatment~     have not been evaluated comprehensively. Therefore, we have planned to analyze predictors for~     visual outcome from a viewpoint of electrophysiology and biomarkers besides morphological~     features by SD-OCT.~   "
122153|NCT01968603|"~     The aim of the study was to describe postoperative weight change in adults undergoing surgery~     for craniopharyngioma and identify preoperative factors associated with it.~   "
122154|NCT01968590|"~     This clinical trial is conducted by one of 4 locations; University of British Columbia~     (Vancouver, CA), University of Utah (Salt Lake City, UT, USA), University of Cincinnati~     (Cincinnati, OH, USA), and University of Hamburg (Hamburg, Germany).~      Adults with NF1 have a higher risk of osteopenia and osteoporosis, a condition of low bone~     density that can lead to fragile bones and bone breakage.~      People with NF1 also have lower vitamin D levels than unaffected individuals. Vitamin D is~     important for normal bone health, but studies to improve bone health by vitamin D~     supplementation in people with NF1 have not been tried.~      The purpose of this study is to treat adults with NF1 who have insufficient serum vitamin D~     levels with 2 different doses of vitamin D supplementation to determine if vitamin D~     supplementation ameliorates the usual loss of bone mineral density over 2 years.~   "
122155|NCT01968577|"~     Patients with stable coronary disease when undergoing percutaneous coronary intervention may~     present periprocedural myocardial infarction defined at present as a creatine~     kinase-myocardial isoenzyme (CK-MB) elevation 3 times upper limit of normal, as a cut off for~     periprocedural myocardial infarction after PCI. Although percutaneous coronary intervention~     is associated with low rates of complications, periprocedural myocardial infarction has been~     touted as a negative factor in long-term clinical results . Several clinical, anatomical and~     technical associate to the occurrence of this event . Although randomized controlled trials~     and systematic reviews to statin pre intervention have targeted the administration of~     high-dose statin is recommended before surgery to reduce the risk of periprocedural~     myocardial infarction, there is no information on the impact of the maximum concentration~     plasma of statin at the time of percutaneous coronary intervention in stable patients on~     chronic statin use in preventing periprocedural myocardial infarction or the elevation of~     cardiac enzymes . The anti-ischemic effect of statins in percutaneous coronary intervention~     was mainly determined in statin -naïve patients or in patients with acute coronary syndromes~     . In this work , we studied the impact of the peak plasma concentration of statin at the time~     of percutaneous coronary intervention was studied through prospective randomized single~     center in stable patients with chronic statin divided into two groups . In the group (1)~     Experimental (n = 268 ) was administered at a dose of 40 mg rosuvastatin between one and six~     hours before surgery and group (2) control without rosuvastatin (n = 268). This range 1 to 6~     hours is the time at the peak concentration of rosuvastatin in the blood after oral~     ingestion. The primary objective was to assess the incidence of periprocedural myocardial~     infarction by creatine kinase above three times upper normal limit in hospital period and as~     a secondary objective to analyze the elevation of any amount of creatine kinase on the~     baseline.~   "
122156|NCT01968564|"~     The proposed study will assess the ability of curcumin, the active ingredient in the Indian~     spice tumeric, to improve the function of arteries with age. Overall, the proposed research~     project has the long-term potential to influence clinical practice guidelines by establishing~     a novel, easy to deliver, cost-effective therapy for treating age-associated arterial~     dysfunction and reducing the risk of cardiovascular disease with age.~   "
122157|NCT01968551|"~     The primary objective of this study is to evaluate the efficacy of~     elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed dose~     combination (FDC) plus darunavir (DRV) relative to current antiretroviral regimens (ARV) in~     virologically suppressed, HIV-1 positive participants with HIV-1 RNA <50 copies/mL at Week~     24.~      This study consists of 48 weeks of open-label phase followed by an optional Extension Phase~     in which all the participants will receive E/C/F/TAF+DRV.~   "
122158|NCT01968538|"~     Prostate cancer is a common disease in men treated using surgery, radiation therapy and/or~     hormonal therapy. Clinical prognosis relates to stage and grade of disease. Recent advances~     in omic analysis may offer additional information to the physician about prognosis and~     radiation response. We propose to establish a protocol to incorporate omic analysis into the~     evaluation and treatment of patients with prostate cancer.~   "
122159|NCT01968525|"~     1. Every individual receiving a general anesthetic is at potential risk for developing a~          ''cannot intubate-cannot ventilate'' situation following anesthetic induction.~        2. Building up of oxygen reserves assumes great significance as this provides a longer~          duration of non-hypoxic apnea should one be faced with an unanticipated difficult~          airway.~        3. The main physiological functions of red blood cell hemoglobin are to deliver oxygen to~          the peripheral tissues.~        4. During anemia, a reduction in blood oxygen content occurs as a result of reduced Hb~          while arterial oxygenation and oxyhemoglobin saturation remain high.~        5. Previous studies about the duration of non-hypoxic apnoea focus on methods to improve~          the safety period of tracheal intubation.~        6. To our knowledge, there is no literature about the duration of non-hypoxic apnoea of~          anemia patients.~        7. The aim of this study was to assess the effect of chronic anemia on the duration of~          non-hypoxic apnoea during induction of anaesthesia.~   "
122160|NCT01968512|"~     Evaluating neurobiological disorder associated with Attention Deficit Hyperactivity Disorder~     (ADHD) and the contribution of transcranial direct current stimulation (tDCS) in the~     adaptation of inhibitory control.~   "
122161|NCT01968499|"~     This registration study aims to investigate the associations of the pharmacogenetic and~     pharmacokinetic factors with clopidogrel low response and clinical outcome in patients with~     coronary artery disease, and provide new pharmacogenetic and pharmacokinetic targets for the~     individualized anti-platelet treatment.~   "
122162|NCT01968486|"~     To demonstrate the efficacy of ranibizumab in combination with reduced-fluence verteporfin~     photodynamic therapy (RF-PDT) in patients with subfoveal choroidal neovascularization~     secondary to pathologic myopia (PM).~   "
122163|NCT01968473|"~     The purpose of this study is to investigate issues relating to comfort and tolerance to~     surface neuro muscular electrical stimulation in a parkinson disease population.~   "
122164|NCT01968460|"~     This study will evaluate an oral fixed-dose, once daily product that combines pramipexole and~     rasagiline for the treatment of early Parkinson's disease.~      Animal studies support the therapeutic advantage of combining low doses of rasagiline and~     pramipexole and suggest further improvement when both are administered in a sustained~     fashion. Both rasagiline and pramipexole are well known marketed drugs for Parkinson's~     disease with a good safety profile. combining the drugs in low doses and controlled release~     may provide better symptom management than the existing drugs alone or together.~   "
122165|NCT01968447|"~     The purpose of this study is to study the effect of variations in the arterial CO2~     concentration during deep neuromuscular block on the surgical conditions as assessed by the~     surgical rating scale~   "
122188|NCT01968148|"~     The aim of the study is to describe the mechanisms of ultra-acute hyperglycemic response~     after return of spontaneous circulation (ROSC) in patients suffering out-of-hospital cardiac~     arrest. The investigators hypothesize that ischemia and reperfusion injury leads decreased~     secretion of insulin and glucose-like peptide 1 (GLP-1).~      Two blood samples will be drawn: (1.) Immediately after ROSC and (2.) 60 minutes after first~     sample. Concentrations of glucose, insulin, glucagon and GLP-1 will be compared between the~     samples.~      Metabolic profile will be compared between: (1.) diabetic and non-diabetic patients and (2.)~     survivors and non-survivors.~   "
122166|NCT01968434|"~     The purpose of this study is to determine if there is comparable efficacy between~     carbocisteine and a protective cough syrup from natural ingredients in children's cough due~     to upper respiratory tract infections (URTI) such as the common cold. The hypothesis is that~     protecting the throat is very useful in decreasing cough severity, both day and night,~     without needing to subdue such an important reflex as cough, and without only acting on~     mucous fluidification, especially in children where sedation and excessive fluidification is~     dangerous. The research hypothesis is that the protective (Grintuss) Syrup relieves cough~     (frequency, intensity, degree of disturbance due to nocturnal cough, and improves the quality~     of sleep of the child) as much as or more than the carbocysteine syrup usually used to treat~     children (Syr Mucolit).~   "
122167|NCT01968421|"~     Non-cystic fibrosis bronchiectasis is characterized by irreversible dilatation of the~     medium-sized bronchi as a result of airway injury due to recurrent or chronic inflammation~     and infection. Bronchiectasis airways are often colonized with bacterial species. Infections~     of the airways are thought to play an important role in bronchiectasis exacerbation. The~     non-specific prevention of recurrent airway infections by immunostimulating agents has gained~     growing scientific interest. OM-85, consisting extracts of eight kinds of bacteria important~     in respiratory infections, has shown the benefit for significantly reducing the incidence of~     exacerbations of chronic obstructive pulmonary disease (COPD). The purpose of this study is~     to investigate the PReventive effect of OM-85 on Bronchiectasis Exacerbation in Chinese~     patients (iPROBE).~      This study is designed as a prospective randomised double-blind placebo-controlled~     multi-centred trial.~   "
122168|NCT01968408|"~     AIM: To determine the efficacy of Lactobacillus reuteri DSM 17938 at a dose of 10(9) CFU for~     the prevention of nosocomial diarrhea.~      TRIAL DESIGN: Double-blind, placebo controlled RCT. INTERVENTION: L reuteri DSM 17938 in a~     daily dose of 10(9) CFU. PRIMARY OUTCOME: Nosocomial diarrhoea (3 or more loose or watery~     stools in a 24 h that will occur more than 72 h after admission).~   "
122169|NCT01968395|"~     The objective of this study is to conduct a population pharmacokinetic analysis of~     caspofungin in a population of patients with moderate and severe acute alcoholic hepatitis or~     liver disease with Child-Pugh score B and C in order to better characterize pharmacokinetic~     parameters in case of moderate and severe liver dysfunction.~   "
122170|NCT01968382|"~     Hypothesis: Oral administration of hyperimmune bovine colostrum enriched with anti-LPS~     antibodies will reduce endotoxemia, and improve pathophysiological and clinical parameters~     related to severe alcoholic hepatitis (SAH).~      IMM 124-E is safe in subjects with severe alcoholic hepatitis being treated with steroids.~      Aim: To perform a phase 2a proof of concept placebo-controlled, dose-ranging study of Imm~     124-E (hyperimmune bovine colostrum enriched with IgG anti-LPS) in subjects with severe AH on~     steroids.~   "
122171|NCT01968369|"~     Several epidemiological and intervention studies suggest that a high dietary intake of~     tomatoes is associated with lower risk of cardiovascular disease (CVD), while, low intake is~     associated with an increased incidence of CVD. This beneficial effects have been attributed~     especially to lycopene, an antioxidant present in high concentration within tomatoes but~     other substances could be of importance.~      Endothelial dysfunction is an early marker of atherosclerosis leading to CVD. The aim of the~     present study is therefore to investigate whether consumption of tomato products ameliorates~     peripheral endothelial function, triggered by a high fat meal, in human volunteers in a~     randomised, crossover dietary intervention study.~      Study design:~      Investigators are randomising healthy men (N=14-28) to consume a high fat meal either with or~     without tomato sauce (80 gr) in a cross-over design with a 7 days wash-out period. During the~     week before the study all the subjects will be maintained in a low fibers diet and only~     subjects randomized to tomatoes will receive a daily dose of 80 mg of tomato sauce (80 gr for~     7 days= total load 560 mg).~      We hypothesize that tomato sauce can improve the deleterious effects of a high fat meal on~     vascular function.~   "
122172|NCT01968356|"~     The purpose of this study is to determine the antimicrobial efficacy of the 3M CHG/IPA Prep~     on skin flora of the abdomen and inguinal regions of human subjects.~   "
122173|NCT01968343|"~     Objective: Trichotillomania is a psychiatric condition characterized by chronic pulling and~     plucking of one's own hair. Cognitive behavioral therapy shows promise as a treatment.~     However, there have been no randomized, controlled studies of the efficacy of group~     cognitive-behavioral therapy. Methods: We evaluated 44 subjects, whom met the criteria for a~     diagnosis of trichotillomania. Subjects were randomized to receive 22 sessions of either~     group cognitive-behavioral therapy or group supportive therapy (control).~   "
122174|NCT01968330|"~     This study will be a randomized controlled trial involving obese women obtaining prenatal~     care at an obstetric care clinic. Study subjects will undergo prenatal care in a group~     setting or prenatal care with a behavioral intervention to improve sleep. Anthropometric~     measurements, blood draws, questionnaires and at home sleep studies will be completed at~     three specified times (two antepartum and one postpartum). Primary outcome will be a~     comparison of postpartum weight loss amongst the intervention and control groups.~   "
122175|NCT01968317|"~     The purpose of this study is to see if megestrol acetate plus metformin will be more~     effective in returning the endometrial tissue to a normal state than megestrol acetate alone~     in patients with endometrial atypical hyperplasia or early stage endometrial adenocarcinoma.~   "
122189|NCT01968135|"~     The specific aims are to determine if more women using Etonogestrel (ENG) contraceptive~     implants who report a bleeding-spotting episode of at least seven days will stop bleeding~     within 3 days of beginning a 14-day course of combined oral hormonal steroids, as compared to~     women receiving 14 days of placebo.~   "
122190|NCT01968122|"~     The SAMMPRIS suggested that aggressive treatment was superior to intravascular stenting in~     patients with severe symptomatic intracranial atherosclerotic stenosis (ICAS) due to high~     complication rate in patients in stenting group. However the intravascular therapy is going~     on because of low complication rate in considerable Chinese studies coming from several high~     volume stroke centers. Given to 12.2% patients failing to aggressive medical therap in the~     SAMMPRIS study, it is imperative to performing an multiple prospective registry study of~     stenting for patients with ICAS in China.~   "
125329|NCT01927003|"~     Multiple digital injuries are often complex and severe, and the commonly used local and~     regional flaps may not be feasible. The authors reconstruct soft tissue defects of the~     fingers using the dorsal digito-metacarpal flap and evaluate the efficacy of this technique.~   "
122176|NCT01968304|"~     In cancerology, anemia is a frequently-found situation, with a prevalence ranging from 30% to~     90%, according to the series, disease stages, primary tumor locations and age (Scotte,~     Launay-Vacher et al. 2012). Although very probably a major cause of anemia, iron deficiency~     (ID) has been seldom investigated in the field of cancer. Its prevalence and incidence have~     never been assessed in a prospective study. It is well-known that anemia in the cancer~     setting is a source of asthenia and deterioration of quality of life, and can even reduce the~     efficacy of anticancer treatments such as radiotherapy. Correcting anemia therefore~     constitutes a daily challenge. Before 2004-2005, a very large proportion of patients were~     treated with erythropoietin (EPO). However, prescriptions for EPO appear to have considerably~     declined since the warnings issued by various scientific societies and governments on account~     of the possible increase in death rates and a higher incidence of thromboembolic events, as~     reported in 8 studies published to date (NCCN 2012). Simultaneously, the transfusion rate~     augmented from 3.4% to 8.7% and the median hemoglobin level fell from 10.8 to 8.9 g/dL~     (Feinberg, Bruno et al. 2012). The use of injectable iron appears to have improved the~     correction of anemia by EPO, as reported in several concordant studies versus oral iron and~     placebo (Pedrazzoli, Rosti et al. 2009; Steensma, Sloan et al. 2011). However, no monotherapy~     study has been conducted to evaluate the impact of injectable iron, alone without EPO, for~     the correction of ID (with or without anemia) in cancer treatment. Consequently, there exists~     a wide variety of practices, with an injectable iron prescription rate which, a priori, does~     not match the number of patients with iron deficiency. There exist other iron-based~     parameters to characterize ID but these are not yet used routinely during chemotherapy and~     need to be validated in the cancer field.~      These parameters include:~        -  An assay of reticulocyte hemoglobin content (rHC)~        -  An assay of soluble transferrin receptor (sTfR) Soluble transferrin receptors are mainly~          located on red blood line cells receiving iron delivered by transferrin.~      In this study, we propose to make a prospective assessment of the iron status of cancer~     patients beginning chemotherapy. The aim is to determine the proportion of patients who might~     benefit from injectable iron treatment. All ID will be covered prospectively over a 2-year~     period.~   "
122177|NCT01968291|"~     The purpose of this study was to determine whether use of teach-back discharge instructions~     improve patient satisfaction and patients' self-reported and objective comprehension of~     discharge instructions in the emergency department when compared to standard discharge~     instructions.~   "
122178|NCT01968278|"~     Oral immunotherapy (OIT) programs for milk, egg and peanut, desensitize patients to their~     respective allergens and thereby decrease their risk of morbidity and mortality. OIT~     programs, however, are not without adverse events, particularly in highly sensitive patients.~     Recently, it has been demonstrated that the administration of baked milk (BM) products to~     IgE-CMA patients that are non-reactive to BM, can promote tolerance to unheated milk (UM).~     The goal of our research is to determine whether BM can promote desensitization even in the~     highly sensitive patient, who reacts to baked milk as well. In a second step, we hypothesize~     BM-OIT will promote desensitization to unheated milk, as well.~      Importance: The change in the risk/benefit ratio of such a program will alter the therapeutic~     approach to an IgE-CMP allergic patient.~      Probable implications to Medicine: BM-OIT will allow highly sensitive patients to tolerate~     milk products, decreasing their risk of life-threatening reactions. Furthermore, analysis of~     the immune modulation parameters that change during the treatment program, should pave the~     way for defining mechanisms underlying tolerance in CMP allergy.~   "
122179|NCT01968265|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of ISIS-GCCRRx~     in combination with metformin versus placebo + metformin~   "
122180|NCT01968252|"~     The study is designed to validate the use of speckle-tracking echocardiography to measure~     tricuspid annular plane systolic excursion as a measurement of right ventricular function~     during transesophageal echocardiography.~   "
122181|NCT01968239|"~     The aim of the trial is to evaluate the efficacy and safety of intravitreal injections of~     ranibizumab for the treatment of macular edema due to BRVO if the re-treatment regimen is~     guided by morphological macular changes detected by OCT compared to re-treatment according to~     SmPC defined re-treatment criteria (in case of increase of CRT and concomitant decrease of~     BCVA).~   "
122182|NCT01968226|"~     The purpose of this study is to investigate the ability of the compound[F-18]RGD-K5, when~     used as a tracer during PET (positron emission tomography) imaging, to detect regions of~     unstable atherosclerotic plaque in the carotid artery of subjects being considered for~     carotid endarterectomy (CEA),and to confirm this ability through histological studies of~     samples of carotid artery plaques that will be collected during the planned carotid surgery.~   "
122183|NCT01968213|"~     Patients enrolled into this study will be stratified into 3 groups based on gene mutations~     identified in their tumor tissue. The purpose of this study is to evaluate patient response~     to maintenance treatment with rucaparib versus placebo. Response to treatment will be~     analyzed based on homologous recombination (HR) status of tumor samples.~   "
122184|NCT01968200|"~     Anthracycline based anti-tumoral therapies are know to develop cardiac damage that could also~     lead to heart failure. Monocentric studies proved that a treatment with ACE inhibitors (ACEi)~     and betablockers (BB) during the first elevation of cardiac troponin is able to reduce the~     incidence of heart failure (HF).~      ICOS-ONE trial is a multicenter randomized trial comparing two therapeutic strategies. The~     main objective is to assess whether enalapril started concomitantly to AC-containing~     treatments, can prevent cardiac toxicity more effectively than when enalapril is prescribed~     to selected patients showing laboratory evidences of injury after chemotherapy, during~     follow-up visits in 268 patients.~   "
122185|NCT01968187|"~     The purpose of this study is to evaluate the safety and effectiveness of intranasal FE 992097~     in children and adults with Prader-Willi Syndrome.~   "
122186|NCT01968174|"~     Eyelid surgeries change the lid position over the cornea. Previous surgeries evaluated~     astigmatic corneal changes in children undergoing ptosis repair. Only several studies~     evaluated astigmatic changes following eyelid surgeries in elderly patients. The~     investigators aim is to estimate this change, implications on corneal astigmatism may have~     great effect to future cataract surgeries for this group of patients.~   "
122187|NCT01968161|"~     We propose a use of a unique facility, the databank at the CNDV, to examine the impact of~     switching subjects to asenapine in an open-label naturalistic setting. This offers the~     following advantages: i) providing data on a particularly important population, i.e.,~     subjects who are at the inception of treatment for a psychotic disorder and who are likely to~     remain on a given drug on a long-term basis; ii) its inclusion in a rich clinical setting,~     with a clinical team dedicated to provide innovative interventions; iii) its naturalistic~     design, that will allow to obtain data that will be applicable to real-life clinical~     settings; indeed, subjects who will be switched to asenapine within the current project are~     those we would switch to this drug in our daily practice.~   "
143954|NCT01683084|"~     The purpose of this study is to determine if telmisartan is effective in slowing the~     progression of abdominal aortic aneurysms and reducing circulating concentrations of~     Abdominal Aortic Aneurysms (AAA) biomarkers.~   "
122191|NCT01968109|"~     The purpose of the study is to assess the safety, tolerability and effectiveness of~     experimental medication BMS-986016 administered alone and in combination with nivolumab in~     patients with solid tumors that have spread and/or cannot be removed by surgery.~      The following tumor types are included in this study:~      Non-Small Cell Lung Cancer (NSCLC), gastric cancer, hepatocellular carcinoma, renal cell~     carcinoma, bladder cancer, squamous cell carcinoma of the head and neck, and melanoma, that~     have NOT previously been treated with immunotherapy. NSCLC and melanoma that HAVE previously~     been treated with immunotherapy.~   "
122192|NCT01968096|"~     Following injury to the spinal cord, the spinal circuit undergoes a series of adaptations. In~     parallel with the spinal circuit adaptation, the muscular properties also adapt. In human and~     animal studies, histochemical and physiological evidences showed that the paralyzed muscle~     transferred from slow, fatigue-resistant to fast, fatigable after injury.~      Reversal of neuromuscular property for persons with SCI needs to be resolved. Studies using~     high load electrical stimulations showed a reverse change of muscular properties, such as~     hypertrophy and reversal of fiber type transformations but failed to show a reversal of~     spinal circuitry function. Previous studies found that fast continuous passive motion (CPM)~     altered the H reflex excitability in human. Animal studies found that passive cycling and~     passive stretching delayed atrophy and influenced the transition of type I and IIa MHC.~     Theses findings lead to a hypothesis that mechanical stimulation might be able to reverse~     both spinal circuitry and muscular properties after SCI but it has not been confirmed in~     human study.~      The purpose of this project is to investigate the effect of mechanical stimulation by fast~     CPM on the reversing adaptation of human paralyzed muscle after SCI.~   "
122193|NCT01968083|"~     Human respiratory syncytial virus (RSV) is a common cause of respiratory illness in infants~     and children. This study will evaluate the safety and immune response to an RSV vaccine in~     healthy RSV-naïve children.~   "
122194|NCT01968070|"~     The main purposes of this study are to evaluate the safety and how well the body handles~     single and multiple doses of increasing strength of study drug, LY3127760. This study~     includes three parts. Part 3 may be initiated at sponsor's discretion, based on data from~     Part 2. Participants will only enroll in 1 of the 3 study parts. This study will last~     approximately 7 to 13 weeks, depending on part. Screening must be completed within 28 days~     prior to enrollment.~   "
122195|NCT01968057|"~     The purpose of this study is to determine the effects of ciclosporin on the amount of~     baricitinib that is absorbed into the blood stream and the time it takes to remove~     baricitinib from the body. The study will also look at how well-tolerated and safe~     baricitinib is, when given alone and in combination with ciclosporin. Side effects will be~     documented. The study will last approximately 6 days from the first dose to the end of the~     study (not including screening or follow-up).~   "
122196|NCT01968044|"~     Therapuetic options are limited for Type 2 Diabetes Mellitus (T2DM) pateints with renal~     impairment. This clinical study is to asses safety and efficacy of the DPP-4 inhibitor~     gemigliptin in patients with type 2 DM and moderate or severe renal impairment for long-term~     peirod (52 weeks).~   "
122197|NCT01968031|"~     This is a study to assess the efficacy and safety of oral Istradefylline (KW-6002) in~     patients with moderate to severe Parkinson's Disease. While on this study, participants will~     continue to take their usual, prescribed, stable regimen of Levodopa/Carbidopa or~     Levodopa/Benserazide therapy plus adjunct Parkinson's medications. Patients will be~     randomized 1:1:1 to receive either Istradefylline 20 mg per day, or Istradefylline 40 mg per~     day or an equivalent placebo. Patients will be treated for a 12 week period to demonstrate~     the effectiveness of Istradefylline in improving Parkinson's disease symptoms (referred to as~     improvement in patient OFF time) and that Istradefylline has an acceptable safety profile in~     this group.~   "
122198|NCT01968018|"~     The purpose of this study is to evaluate the analgesic (painkiller) effectiveness and safety~     of combination of tramadol HCI (37.5 mg)/acetaminophen (325 mg) in the treatment of chronic~     cancer pain.~   "
122199|NCT01968005|"~     The purpose of this study is to evaluate efficacy, tolerability and safety of~     Etoreat®(Etodolac-Lidocaine Topical Patch) in the treatment of acute low back pain (LBP).~   "
122200|NCT01967992|"~     The study is a pilot, designed to provide data regarding the feasibility and acceptability of~     conducting such a study on a larger scale. The present study is a randomized controlled~     clinical trial comparing two programs to help people manage diabetes and lose weight, one~     using a moderate-carbohydrate diet promoted by the American Diabetes Association (ADA) and~     the other using on a low-carbohydrate diet (LC) and mindfulness and positive affect lifestyle~     modifications. Intervention content will include information about nutrition (American~     Diabetes Association recommended diet or carbohydrate restriction) and, in the LC group,~     emotion regulation, positive affect, and mindful eating strategies.~   "
122201|NCT01967979|"~     This single-center, open-label, one-sequence, 2-period, within-subject study in 2 cohorts~     will evaluate the effects of multiple doses of itraconazole and fluoxetine on the~     pharmacokinetics of a single dose of RO5285119 in healthy volunteers. In Cohort 1, subjects~     will receive a single dose of RO5285119 on Day 1 (Period 1) and, after a wash-out period of~     14 days, itraconazole on Days 1-8 of Period 2 with coadministration of RO5285119 on Day 4. In~     Cohort 2, subjects will receive a single dose of RO5285119 on Day 1 (Period 1) and, after a~     wash-out period of 14 days, fluoxetine on Days 1-12 of Period 2 with coadministration of~     RO5285119 on Day 6.~   "
122202|NCT01967966|"~     This 2-arm, open-label, non-randomized study will investigate the absolute bioavailability,~     pharmacokinetics, mass balance, and routes of elimination of GDC-0032 as well as its safety~     in healthy volunteers. Patients will receive either a single oral dose of GDC-0032 followed~     by a 14C-labeled IV dose of GDC-0032 or a single oral dose of 14C-labelled GDC-0032.~   "
122203|NCT01967953|"~     The recent introduction of ex-vivo lung perfusion (EVLP) as a tool to evaluate and~     recondition lungs from marginal donors has opened a new era in the field of lung~     transplantation.~   "
122241|NCT01967459|"~     Administration of vitamin D will have a beneficial effect on postprandial leukocyte~     activation, oxidative stress and arterial stiffness in vitamin D deficient females. High~     doses of vitamin D may have a more pronounced effect than low doses.~   "
132992|NCT01826526|"~     The purpose of this study is to determine if TauroSept® taurolidine 2% is more efficient than~     saline solution 0.9% as a catheter lock solution in preventing catheter related blood stream~     infections in patients with home parenteral nutrition.~   "
122204|NCT01967940|"~     Part 1 consists of 2 cohorts, starting with a sentinel cohort, in which approximately 10~     participants will be enrolled to receive open-label tenofovir alafenamide (TAF) in addition~     to their current failing antiretroviral (ARV) regimen. This cohort will then be followed by a~     randomized, double-blind, cohort of approximately 90 participants to compare the addition of~     TAF or placebo in HIV-1 positive adults who are failing their current ARV regimen.~      In Part 2, all participants who complete Part 1 of the study will discontinue their failing~     ARV regimen and TAF or placebo for a 14-day washout period. Following the washout period, all~     participants who received TAF in Part 1 and have a > 0.5 log10 decline in HIV-1 RNA will~     receive elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) single-tablet~     regimen (STR) plus atazanavir (ATV) once daily for 48 weeks. Participants who received TAF~     who have a ≤ 0.5 log10 decline in HIV-1 RNA will be discontinued from the study and will not~     be eligible to continue into Part 2 of the study. All participants who received placebo in~     Part 1 will be eligible to participate in Part 2 regardless of their viral load change.~   "
122205|NCT01967927|"~     To estimate the mean and standard deviation (SD) of the post-treatment decreases in the~     interstitial fluid pressure and hypoxia-specific PET-scan signal from GRID-treated tumors in~     patients with locally advanced squamous-cell carcinoma of the head and neck.~      The possible effects of GRID radiotherapy on tumor oxygenation levels and interstitial fluid~     pressure within the tumors will be measured by assessing the trend and statistical~     significance of the difference in values for each condition obtained prior to and just after~     GRID exposure in each subject enrolled in the study. We expect that there may be a trend for~     increases in tumor oxygenation and decreases in interstitial fluid pressure which would~     indicate that more accurately timed additional chemotherapy and radiation therapy would~     improve overall patient outcomes.~   "
122206|NCT01967914|"~     The hypothesis is that plethysmography variability index can predict the occurrence of~     hypotension after spinal anesthesia for cesarean delivery~   "
122207|NCT01967901|"~     Diabetic Kidney Disease (DKD) is becoming a global health concern that affects largely the~     elderly population. Despite advances in pharmacological and management strategies, DKD remain~     associated with high morbidity and mortality. Patients living with such chronic disease, are~     expected, on daily basis to manage their self-care activities. Patients' non-adherence to the~     treatment is thought to be the major cause for the poor control and the occurrence of~     complications. Previous researchers have shown that multidisciplinary management of chronic~     disease can improve patients' self-care and outcomes. However, none of these programs was~     centered on self-care and targeted patients with DKD. A multidisciplinary self-care~     management program could improve the outcomes of patients with DKD, and delay the progression~     of the disease.~      The aim of the study is to investigate the effect of a multidisciplinary self-care management~     program on self-care behavior, quality of life, medication adherence, glycemic control and~     renal function, in adults with DKD.~      The study will use a cross-over design. 32 adult with DKD, will be randomly recruited from~     the Vaud University Medical Center, nephrology department and will be enrolled in the program~     for 12 month. All variables will be measured at baseline, three, six, nine and 12 month. We~     will measure the patients' self-care behavior, quality of life, adherence to the~     anti-hypertensive medication taking using, the Revised Summary of Diabetes Self-Care~     Activities questionnaire, the Audit of Diabetes-Dependent Quality of life questionnaire and~     the Medication Events Monitoring System. We will assess the patients' glycemic control by~     measuring the glycated hemoglobin and the renal function by measuring the serum creatinine~     and the microalbumin creatinine ratio.~      The study will clearly show if a multidisciplinary self-care management program will improve~     the health outcomes of patients with DKD and will allow us to recommend the establishment of~     such a program.~   "
122208|NCT01967888|"~     The study will be a phase 2/3, multicenter, double-blind, parallel assignment study. It will~     involve 100 adult recipients of an intra-hepatic pancreatic Islet Auto-Transplantation (IAT).~      The objective of this clinical trial is to assess whether reparixin leads to improved~     transplant outcome as measured by the proportion of insulin-independent patients following~     IAT. The safety of reparixin in the specific clinical setting will be also evaluated.~   "
122209|NCT01967875|"~     The purpose of this study is to determine whether ERCC1(excision repair cross-complementation~     1 ) expression has effects on platinum-based chemotherapy for patients with locally advanced~     or metastatic gastric cancer, and to explore if ERCC1 can act as a biological predictor for~     the individual therapy of gastric cancer~   "
122210|NCT01967862|"~     This phase II trial studies how well fluorine F 18 sodium fluoride positron emission~     tomography (PET)/computed tomography (CT) and whole body and axial magnetic resonance imaging~     (MRI) work in finding metastases in patients with recurrent prostate cancer. New imaging~     techniques, such as fluorine F 18 sodium fluoride PET/CT and whole body and axial MRI, may be~     more effective than standard CT and bone scan in finding metastatic prostate cancer.~   "
122211|NCT01967849|"~     The purpose of this study is to determine the prevalence of impaired glucose (carbohydrate)~     tolerance in lean children with a family history of diabetes and in overweight/obese children~     with or without a family history of diabetes mellitus.~   "
122212|NCT01967836|"~     The purpose of this study is to see if Glad Press 'n Seal works as a moisture barrier for~     central line that is left in place during ambulatory oncology clinical care.~   "
122213|NCT01967823|"~     Background:~      The NCI Surgery Branch has developed an experimental therapy for treating patients with~     cancer that involves taking white blood cells from the patient, growing them in the~     laboratory in large numbers, genetically modifying them, and then giving the cells back to~     the patient. In a previous study the NCI Surgery Branch used the anti-ESO-1 gene and a type~     of virus (retrovirus) to make these tumor fighting cells (anti-ESO-1 cells). About half of~     the patients who received this treatment experienced shrinking of their tumors. In this~     study, we are using a slightly different method of producing the anti-ESO-1 cells which we~     hope will be better in making the tumors shrink.~      Objectives:~      The purpose of this study is to see if these tumor fighting cells (genetically modified~     cells) that express the receptor for the ESO-1 molecule on their surface can cause tumors to~     shrink and to see if this treatment is safe.~      Eligibility:~      - Adults 18 years old and older with cancer that has the ESO-1 molecule on their tumors.~      Design:~        -  Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and~          undergo a history and physical examination, scans, x-rays, lab tests, and other tests as~          needed~        -  Leukapheresis: If the patients meet all of the requirements for the study they will~          undergo leukapheresis to obtain white blood cells to make the anti ESO-1 cells.~          {Leukapheresis is a common procedure which removes only the white blood cells from the~          patient.}~        -  Treatment: Once their cells have grown the patients will be admitted to the hospital for~          the conditioning chemotherapy, the anti-ESO-1 cells and aldesleukin. They will stay in~          the hospital for about 4 weeks for the treatment.~        -  Follow up: Patients will return to the clinic for a physical exam, review of side~          effects, lab tests, and scans about every 1-3 months for the first year, and then every~          6 months to 1 year as long as their tumors are shrinking. Follow up visits take up to 2~          days.~   "
122214|NCT01967810|"~     This is a Phase 2 study to see if an investigational drug, ANG1005, can shrink tumor cells in~     patients with high-grade glioma. Another purpose of this study is to assess the efficacy,~     safety, tolerability, and pharmacokinetics (PK) of ANG1005 in patients.~   "
122819|NCT01959880|"~     The CPG Styles Study is designed to demonstrate the safety of different styles of Mentor's~     Contour Profile Gel (CPG) breast implants in women who are undergoing primary augmentation,~     primary reconstruction, or revision. Safety information on the rate of capsular contracture,~     rupture and infection will be collected and used to determine device safety.~   "
122215|NCT01967797|"~     The main goal of this project is to develop, implement and evaluate the 5As Team intervention~     (5AsT)for healthcare practitioners to improve their weight management patient encounters and~     improve patient health outcomes. The 5As of Obesity Management suite of tools is a robust,~     evidence-based approach to weight management, however its implementation and uptake has been~     heterogeneous in primary care.~      This project was co-created by, and will be implemented with, our partners the Southside~     Primary Care Network (SSPCN). A needs assessment on weight management by the SSPCN revealed~     the need to change provider practice to increase the number of weight management visits.~     Despite a robust didactic training session on weight management for all providers, which~     includes the 5As, the uptake in practice has been highly heterogeneous. Thus, the 5AsT~     intervention to address the implementation of the 5As of Obesity Management in clinical~     practice was developed by the collaborative team. The SSPCN consists of 25 autonomous groups~     of multidisciplinary professionals that provide service to a defined group of patients within~     the SSPCN.~      The 5As Team consists of multidisciplinary providers (Registered Nurse/ Nurse Practitioner,~     dietician, mental health worker) who work collaboratively. The intervention is a learning~     collaborative where these 12 different 5AsTs get together to work to address facilitators and~     barriers to weight management in their settings over a 6 month period. Half of the teams~     (N=12) will remain as controls and deliver usual care. They serve as a comparison group for~     the 5AsTs. This mixed methods study's primary outcomes will assess the change in provider~     practice and the effectiveness of the intervention and implementation.~      To assess the impact of 5AsT on patients, we will recruit patients presenting to the central~     SSPCN programming, We will not intervene directly on patients; we will observe the impact of~     the 5AsT and SSPCN programming on their health outcomes for a minimum of 6 months, and where~     possible for 18 months. Data collected includes demographics, weight (BMI), waist~     circumference, vital signs,and Short Form-12 (SF-12,these measures are routinely measured in~     the SSPCN), EuroQol-5 dimensions 5 Level (EQ-5D-5L), modified patient assessment of chronic~     illness (PACIC), and observed adherence to routine clinical care for guideline recommended~     laboratory monitoring (cholesterol panel, fasting glucose, HbA1c, where appropriate).~   "
122216|NCT01967784|"~     The aim of the study is to describe the immunogenicity and safety of the new formulation of~     Quadrivalent Influenza Vaccine (QIV) for the 2013-2014 season in the Northern Hemisphere (NH)~     in subjects aged 9 to 17 years in Taiwan~      Primary Objective:~        -  To describe the immunogenicity of the QIV (split-virion, inactivated) NH seasonal~          formulation~      Secondary Objective:~        -  To describe the safety of the QIV (split-virion, inactivated) NH seasonal formulation~   "
122217|NCT01967771|"~     This study will be a phase I, open label, three period, fixed sequence crossover study to~     evaluate the effect of Carbamazepine (CBZ) on the steady-state pharmacokinetics of~     Dolutegravir (DTG) and on the safety and tolerability of DTG. Subjects will have a screening~     visit within 30 days prior to the first dose of study drug, three treatment periods, and a~     follow-up visit 7-14 days after the last dose of study drug. There is no washout between~     treatment periods.~   "
122218|NCT01967758|"~     This is a study for patients with brain tumors called astrocytic tumors. The study will~     enroll patients who have received standard treatment. The study will test a vaccine called~     ADU-623. ADU-623 has not been tested in humans before, so the goal of this study is to see if~     ADU-623 can be given safely to brain cancer patients and what is the better dose to give~     patients among the three doses that planned to be tested. This study will also evaluate the~     length of time before patients' cancer worsens and if ADU-623 helps patients to live longer.~     The study will also measure the body's immune system response to ADU-623.~   "
122219|NCT01967745|"~     Comparison of open and laparoscopic appendectomy~   "
122220|NCT01967732|"~     The primary objective of this clinical study is to evaluate the pharmacokinetic (PK) profile~     (rate and amount of nicotine absorbed) following a single use of the THS 2.2 compared to the~     PK profiles from a single use of a conventional cigarette (CC) and from a single use of~     nicotine nasal spray (NNS).~   "
122221|NCT01967719|"~     The primary objective of the study is to evaluate the pharmacokinetic (PK) profiles (rate and~     amount of nicotine absorbed) after a single use of the THS 2.2 Menthol (mTHS 2.2) compared to~     a single use of the menthol conventional cigarette (mCC) and nicotine nasal spray (NNS).~   "
122222|NCT01967706|"~     The primary objective of this clinical study is to evaluate the pharmacokinetic (PK) profile~     (rate and amount of nicotine absorbed) following a single use of the THS 2.2 Menthol (mTHS),~     a candidate Modified Risk Tobacco Product, compared to the PK profiles from a single use of a~     menthol cigarette (mCC) and from a single use of nicotine replacement therapy gum (NRT).~   "
122223|NCT01967693|"~     Retrospective analysis of data from patients with laryngeal contact granulomas in order to~     identify possible differences and/or similarities between the cases and in order to determine~     whether and which conclusions can be drawn on disease and therapy.~   "
122224|NCT01967680|"~     Background: Every year 30,000 Danish patients are admitted to Intensive Care Units (ICU),~     accounting for 2-3% of all patients in hospital and 30% of the yearly hospital expenditure.~     The mortality in the ICU is 12.7 % and the 30-day mortality is 21.2 % according to the~     national Danish Intensive Care Database. Through many years, the standard care has been to~     use continuous sedation of critically ill patients during me-chanical ventilation. However,~     recent research indicates that it is beneficial to reduce the sedation level in these~     patients. A randomised trial found that continuous sedation with a daily wake-up trial~     compared to continuous sedation reduced the time on me-chanical ventilation and the length of~     stay in the intensive care unit. Further, a ran-domised trial comparing continuous sedation~     with a daily wake-up trial to no sedation found that patients in the non-sedated group needed~     mechanical ventilation for a shorter time and had a shorter length of stay in the ICU and in~     the hospital. The trial also indicated a beneficial effect on mortality, however the trial~     was not a priori de-signed or powered with respect to mortality. No randomised trial has been~     published comparing sedation with no sedation, a priori powered to have all-cause mortality~     as primary outcome.~      Objective: To assess the benefits and harms of non-sedation versus sedation with a daily~     wake-up trial in critically ill patients in ICU.~      Design: The NONSEDA trial is an investigator-initiated, randomised, clinical, parallel-group,~     multinational, superiority trial designed to include 700 patients from at least six ICUs in~     Denmark, Norway and Sweden.~      Inclusion criteria: Mechanically ventilated patients with expected duration of me-chanical~     ventilation > 24 hours.~      Exclusion criteria: non-intubated patients, patients with severe head trauma, coma at~     admission or status epilepticus, patients treated with therapeutic hypothermia, patients with~     PaO2/FiO2<9 where sedation might be necessary to ensure sufficient oxygenation or place the~     patient in prone position.~      Experimental intervention: Non-sedation supplemented with pain management during mechanical~     ventilation.~      Control intervention: Sedation with a daily wake-up trial.~      The primary hypothesis is that non-sedation compared to sedation and a daily wake-up trial~     will reduce mortality.~      The secondary hypotheses are that non-sedation compared to sedation and a daily wake-up trial~     will:~        -  Reduce the incidence of a composite outcome of death, acute myocardial in-farction~          (AMI), stroke, pulmonary embolism and other thromboembolic events.~        -  Reduce the number of organ failures.~        -  Increase the days alive without mechanical ventilation.~        -  Increase the days alive outside the ICU.~        -  Increase the days alive outside the hospital.~      Outcomes: The primary outcome is all-cause mortality at 90 days. Secondary out-comes are time~     to death in the trial period, the frequency of the trombo-embolic com-plications, acute renal~     failure, days alive without mechanical ventilation, days alive outside the ICU and hospital.~     Explorative outcomes are mortality at 28 days, organ failure and coma-free, delirium-free~     days.~      Trial size: The investigators will include 700 participants (2 x 350) in order to detect or~     reject 25% relative risk reduction in mortality with a type I error risk of 5% and a type II~     error risk of 20% (power at 80%).~   "
122225|NCT01967667|"~     Low levels of antioxidant molecules such as glutathione have been found in people with a~     diagnosis of schizophrenia. However, oral glutathione is not well absorbed because the~     compound is mostly broken down in the gastrointestinal system. Liposomes are tiny droplets of~     oil particles that encapsulate and protect the glutathione. In this study we will evaluate a~     liposomal formulation of glutathione for tolerability and to examine if this formulation~     serves the function of increasing glutathione in the brain and body.~   "
122820|NCT01959867|"~     This is a prospective clinical study comparing two-stage breast reconstruction following~     mastectomy with and without the use of SurgiMend® PRS fetal bovine collagen matrix in~     patients with pre-mastectomy radiation therapy.~   "
122226|NCT01967654|"~     Vietnam has a smoking prevalence that is the second highest among South East Asian countries~     (SEACs). With a population of approximately 90 million, Vietnam also has the second largest~     total number of adult smokers (over 16 million) in SEA. According to the World Health~     Organization (WHO), most reductions in mortality from tobacco use in the near future will be~     achieved through helping current users quit. Tobacco use treatment, as defined by the U.S.~     Preventive Health Service Guideline (Guideline) on Treating Tobacco use and Dependence, is~     evidence-based and highly cost-effective. Yet, in the U.S. and globally, adoption of~     recommended care is suboptimal. The objective of this proposal is to fill the current~     research-to-practice gap by conducting a randomized controlled trial that compares the~     effectiveness and cost effectiveness of two practical and highly replicable strategies for~     implementing evidence-based guidelines for the treatment of tobacco use in public health~     clinics in Vietnam. The proposed implementation strategies draw on evidence-based approaches,~     and the WHO's recently released guidelines for implementing Article 14 of the Framework~     Convention on Tobacco Control (FCTC). The FCTC is an evidence-based treaty that was developed~     by the WHO in response to the globalization of the tobacco epidemic. Vietnam ratified the~     FCTC in 2004; however, they have not taken steps to implement Article 14 which specifies the~     need to integrate best practices for treating tobacco use and dependence into routine~     preventive care. The proposed implementation strategies also build on the growing literature~     that supports the effectiveness of integrating community health workers as members of the~     health care team to improve access to preventive services.~   "
122227|NCT01967641|"~     In this study, we will assess opioid self-administration in a laboratory setting in persons~     with pain who have a history of opioid abuse. Participants diagnosed with mild to moderate~     pain will be admitted to hospital for 7 weeks and transitioned from their baseline~     prescription opioid to a standing daily dose of Suboxone (buprenorphine/naloxone~     combination). During this maintenance period, participants will have the opportunity in a~     laboratory setting to self-administer oxycodone; subjective responses as well as analgesic,~     physiological and performance effects will be measured. In the second phase of this study,~     the same patients who participated in the inpatient phase will be followed on an outpatient~     basis while maintained on Suboxone for 12 weeks. . The hypotheses of this study are that (1)~     higher progressive ratio break-point values for oxycodone, higher subjective ratings of~     euphoria, and less pain relief will predict early relapse to opioid abuse; (2) the abuse~     liability measures will be more strongly correlated with relapse than the pain measures; (3)~     subjective ratings of euphoria will increase and of pain will decrease in an oxycodone~     dose-dependent manner (i.e. euphoria will increase and pain will decrease as dose increases);~     and (4) experimentally induced pain will decrease in an oxycodone dose-dependent manner.~   "
122228|NCT01967628|"~     For most individuals, the lung has a remarkable ability to deal with exposure to a variety of~     inhaled bacteria. Some individuals, however, do have recurrent bacterial infections, usually~     in the form of acute or chronic bronchitis and, in some instances, pneumonia. The reasons for~     this variability in bacterial infections between otherwise healthy subjects, between types of~     lung disease, and within the same type of lung disease are poorly understood.~      Variability in susceptibility to bacterial infections is partially explained by differences~     in exposure to infectious agents, genetic susceptibility and innate (or early) immune~     responses. It is of interest that the incidence and severity of bacterial infections is~     greatest during the winter months. Other than viral infections, there are few variables that~     change with season. Vitamin D is one known immune modulator with a seasonal periodicity. The~     hypothesis of this study is that levels of vitamin D are an important determinant of the~     innate defense of the lung against inhaled bacteria. The investigators further postulate that~     vitamin D has effects on the innate immune function of both alveolar macrophages and lung~     epithelial cells.~   "
122229|NCT01967615|"~     Prasugrel and ticagrelor were both associated with a significant reduction in the risk of~     MACE in patients undergoing PCI for an ACS, mostly through a reduced stent thrombosis. The~     1-year relative risk reduction (RRR) of definite of probable stent thrombosis in patients~     receiving a DES were fairly different in TRITON-TIMI 38 and PLATO trials. The incidence of~     biologically active stent (DES or BVS) thrombosis is largely variable according to~     different lesion settings. We aim to verify the translation of the postulated different~     reduction in thrombosis rate among various P2Y12 inhibitors (clopidogrel, prasugrel and~     ticagrelor) in a high-risk setting such as the PCI with DES or BVS in CTO and bifurcating~     lesions.~   "
122230|NCT01967602|"~     The goal of this project is to find a marker expression that the investigators can use to~     trace symptom progression and develop a more efficient therapy to enhance ARDS patient~     survival rate and better post-ICU life quality.~   "
122231|NCT01967589|"~     This trial is conducted in Europe. The aim of the trial is to investigate safety,~     tolerability, pharmacokinetics (the exposure of the trial drug in the body) and~     pharmacodynamics (the effect of the investigated drug on the body) of multiple doses of a~     long acting GLP-1 analogue (NNC0113-0987) in healthy male subjects.~   "
122232|NCT01967576|"~     Background:~        -  Most treatments for malignant pheochromocytomas/paragangliomas (PHEO/PGL) are palliative~          and multidisciplinary. Chemotherapy using the combination of cyclophosphamide,~          vincristine, and dacarbazine has been successfully utilized in the management of rapidly~          progressive metastatic PHEO, with more than 50% complete or partial tumor response and~          more than 70% complete or partial biochemical response.~        -  VEGF expression and evidence of angiogenesis has been found in many PHEO/PGL, so it is~          plausible that interfering with VEGF signaling may result in anti-tumor activity in~          patients with PHEO/PGL.~        -  Axitinib (AG-013736) is an oral, potent and selective inhibitor of vascular endothelial~          growth factor (VEGF) receptors 1, 2, and 3. Pre-clinical data suggests that the~          anti-tumor activity of axitinib may result from its anti-angiogenic activity and that~          this is reversible when treatment is discontinued.~        -  Given the known clinical safety and efficacy of axitinib, an assessment of its activity~          in PHEO/PGL and its impact on the VEGF pathway in PHEO/PGL could provide valuable~          information.~      Objectives:~        -  Determine the response rate of metastatic PHEO/PGL to axitinib (AG-013736).~        -  Determine the progression-free survival of metastatic PHEO/PGL treated with axitinib~          (AG-013736).~        -  Explore the relationship of potential biological markers of axitinib activity with~          clinical outcomes.~        -  Perform pharmacogenomics analyses of drug metabolism and transport proteins through~          germline DNA examination.~      Eligibility:~        -  Adults with a confirmed pathologic diagnosis of PHEO/PGL by the Laboratory of Pathology,~          NCI~        -  Biochemical evidence of PHEO/PGL~        -  Imaging confirmation of metastatic, locally advanced or unresectable disease.~        -  Measurable disease at presentation~        -  ECOG performance status less than or equal to 2~        -  Patients must not have received prior therapy with a tyrosine kinase (TK) inhibitor~      Design:~        -  Phase II, open label, non-randomized trial~        -  Patients with metastatic pheochromocytoma/paraganglioma will receive axitinib (AG-~          013736 BID) in eight-week cycles~        -  Patients will be evaluated for response every eight weeks using RECIST criteria~        -  Tumor biopsies are not mandatory but every attempt will be made to obtain these from~          patients prior to starting axitinib and again 20 -30 days after treatment has begun.~        -  Approximately 12 to 37 patients will be needed to achieve the objectives of the trial~   "
122233|NCT01967563|"~     Background:~      - Popular weight loss plans often restrict carbohydrates or fat. Research shows that~     very-low-carbohydrate (ketogenic) diets lead to greater weight loss than low-fat diets.~     Researchers want to know if eating fewer carbohydrates changes the number of calories the~     body uses. They also want to know how a ketogenic diet affects hunger, hormones, and food~     preferences.~      Objectives:~      - To better understand how the body responds to different diets.~      Eligibility:~      - Men 18 to 50 years old who are healthy but overweight.~      Design:~        -  Participants will have 3 screening visits:~             1. Medical history, physical exam, blood test, and EKG. They will eat during the~               visit.~             2. For the week before the visit, participants will wear physical activity monitors~               daily. They will record everything they eat and sample the special diet. At the~               visit, they will receive an EKG and heart rate test while biking for 30 minutes.~             3. For the week before the visit, participants will wear the physical activity~               monitors. They will eat all their meals from the special diet that will be~               provided. At the visit, they will answer questions and bike for 60 minutes.~        -  After screening, for 1 week, participants will visit the clinic daily to receive that~          day s food. They will not eat or drink anything else except water.~        -  Then participants will stay at the clinic for 8 weeks. They cannot leave but can have~          visitors. Participants will wear physical activity monitors, bike daily, and follow~          different diets. Tests will be given daily, and may include weighing, X-rays, and blood~          and urine tests. They will spend several days in a monitored room to test oxygen and~          carbon dioxide.~   "
122234|NCT01967550|"~     This study will evaluate the efficacy and safety of diclofenac DDEA 2.32 % in patient~     suffering from knee osteoarthritis (OA).~   "
122235|NCT01967537|"~     Background:~      - Neuroendocrine tumors (NETs) are rare but have been more common over the past decade. The~     only treatment for NETs is surgery, but most are found when they are too advanced for~     surgery. Researchers are looking for the best way to find NETs earlier, so that surgery can~     be successful. They want to test if the study drug can be used along with imaging devices to~     detect NETs.~      Objectives:~      - To see how well a new experimental imaging agent, 68Gallium-DOTATATE, detects unknown~     primary and metastatic NETs in the gastrointestinal system and pancreas.~      Eligibility:~      - Adults over 10 years old with a suspected NET or family history of NET.~      Design:~        -  Participants will be screened with a medical history and physical exam, and have a blood~          test.~        -  Participants will undergo three scans. For all of these, a substance is injected into~          their body, they lie on a table, and a machine takes images.~      <TAB>- A standard CT scan of the chest, abdomen, and pelvis.~      <TAB>- An octreotide scintigraphy SPECT/CT.~      <TAB>- A 68Gallium-DOTATATE PET/CT. The study drug is injected into a vein, usually in the~     arm. Low-dose X-rays go through the body. For about 40 minutes a large, donut-shaped device~     takes images of the body. The entire session takes 90 to 120 minutes.~        -  Researchers will compare images from the three scans.~        -  Participants will have 1 follow-up visit each year for 5 years. At this visit, they will~          have a medical exam, blood taken, and a CT scan.~   "
122236|NCT01967524|"~     Myofascial pains are frequently found during the clinical examination of the patients~     presenting a painful chronic syndrome of the pelvis or the perineum. If the physiopathology~     of this component of the pain characterized by triggerpoints found in the clinical~     examination, remains uncertain; its coverage contributes to the improvement of the global~     pain of the patient. The physiotherapy can be useful but when it is not useful, we proposed~     injections of triggerpoints by local anesthetics. The injections of botulinum toxin on these~     triggerpoints have a legitimacy (action on the muscular cramp and action on the afferent~     fibers) but are they superior to the injections of local anesthetics of triggerpoints? The~     literature remains poor on the subject, justifying this randomized double-blind protocol~     comparing the efficacy of the botulinum toxin associated with a local anesthetic versus local~     anesthetic alone with a main criterion of evaluation in 2 months and a monthly follow-up as~     long as the patient remains improved and maximum in 6 months.~   "
122237|NCT01967511|"~     The purpose of this study has evolved and expanded since its inception. Originally the intent~     was to establish the functional, molecular and genetic profile of fibroblasts from~     Fibromuscular Dysplasia (FMD) patients as compared to carefully matched control subjects.~     While this remains among the objectives, the study has been expanded to undertake a fully~     powered cross-tissue systems genetics analysis of FMD, and now also the related~     arteriopathies spontaneous coronary artery dissection (SCAD) and cervical artery dissection~     (CvAD). The overall objective is to disclose the core biologic mechanisms of these disorders.~   "
122238|NCT01967498|"~     The purpose of our double-blind, placebo controlled study is to test the hypothesis that~     montelukast therapy might be associated with improved hearing in certain sub populations of~     children suffering from OME.~   "
122239|NCT01967485|"~     The purpose of this study is to determine if an individualized text messaging intervention~     for the parents of children with Attention Deficit/Hyperactivity Disorder is effective in~     improving medication adherence and disease management.~   "
122240|NCT01967472|"~     The aim of this study is to address this gap in knowledge by measuring the level of patient~     adherence to co-formulated amodiaquine and artesunate (AQ-AS) compared to~     artemether-lumefantrine (AL) under routine conditions in Sierra Leone and explore the key~     factors that influence adherence. This will be addressed through a mixed methods study that~     will provide not only a measurement of adherence ACTs and malaria test results, but will also~     provide contextual information in order to better understand factors that affect adherence.~     Data will be collected through a series of interviews with health workers and~     parents/caregivers and through observations of patient-provider consultations.~      The first stage of the study begins with semi-structured interviews and observations of~     patients/caretakers' consultations with health workers and will look at how health workers~     diagnose and treat malaria. This will be followed by short exit interviews at the health~     facility with caregivers to assess patient satisfaction with services, as well as to test the~     consistency between the data obtained through structured observations and the exit~     interviews.~      Follow-up surveys at the homes of patients will be used to measure and compare the adherence~     of participants to two different ACTs (AQAS and AL) formulations and potential factors that~     affect adherence. Additionally, data will be collected using in-depth interviews to collect~     supplementary information in order to discover, in more detail, factors that may affect~     behavioral choices and/or attitudes with regard to adherence.~   "
122245|NCT01967407|"~     The aim of the study is the evaluation of the ablation efficiency of the percutaneous~     irreversible electroporation (IRE) as primary ablation therapy of locally confined renal cell~     carcinoma (≤4cm, see inclusion and exclusion criteria).~      The ablation success will be proofed by magnet resonance imaging (MRI) and histologically~     after partial kidney resection or nephrectomy 4 weeks after IRE. Hypotheses: Kidney tumors~     ≤4cm can be ablated completely by percutaneous IRE. Surrounded structures and renal tissue~     can be preserved.~   "
122246|NCT01967394|"~     Approximately 400,000 live births occur to adolescents in the United States annually. Of the~     50% of adolescent mothers who experience depressive symptoms, less than 25% comply with~     referrals for depression evaluation and treatment due to lack of knowledge of depression~     symptoms (literacy), negative attitude towards mental health treatment, perception that~     individuals with depression are stigmatized (subjective norms), lack of understanding of~     health resources that are available to her and under her control (perceived control), and~     lack of time. Social media is a promising vehicle to reach and educate adolescent mothers~     since most adolescent mothers use social media for communication and to search for health~     information. Based upon the Theory of Planned Behavior, the investigators will target 11~     counties in Kentucky with a social media ad campaign that will result in adolescent mothers~     (n=140) from those counties enrolling in an internet based intervention related to postpartum~     depression. The previously tested intervention includes vignettes from other adolescent~     mothers, questions and answers, resources, and an option to enroll in text message service.~     Before the intervention, after the intervention, and two weeks later the adolescent mothers~     will complete established questionnaires to determine if the intervention improved attitude~     and subjective norms towards depression and depression treatment, perceived control and~     intention related to seeking depression treatment, and the number of adolescent mothers with~     symptoms of depression who receive depression treatment. Data will be compared to scores on~     the same instruments from adolescent mothers (n=140) from the control group (18 other~     counties in Kentucky) that have not been targeted with the social media ad campaign or~     participated in the intervention. Data from the adolescent mothers in the control group will~     be collected in partnership with community agencies. The overall purpose of this trial is to~     test a cost effective and feasible method for reducing the cognitive and emotional barriers~     to accessing depression treatment in adolescent mothers. The specific aims are to (1) measure~     the extent to which a social media ad campaign is effective as a recruitment strategy; (2)~     test the effectiveness of an internet based social marketing intervention on both intention~     to seek treatment and rates of depression treatment, and (3) examine the dose effect of the~     intervention.~   "
122247|NCT01967381|"~     The research proposed in this application will determine the initial efficacy, safety and~     tolerability of a novel drug combination, oxazepam (Serax®) and naltrexone (Revia®), as a~     pharmacotherapy for methamphetamine (Desoxyn®) dependence. A rigorous, inpatient human~     laboratory study will be conducted. The proposed study is innovative and important because it~     will provide the impetus for the conduct of double blind, placebo-controlled trials to~     further demonstrate the efficacy of combined oxazepam and naltrexone for managing~     methamphetamine dependence.~   "
122248|NCT01967368|"~     Influenza is associated with significant morbidity and mortality. Institutionalized older~     adults (age>65) is the group associated with highest risk of complications. Influenza~     vaccines are the cornerstone of influenza prevention but one systematic review has found that~     there is no statistically significant difference against laboratory confirmed influenza. A~     major reason is immune senescence in older adults which result in weaker response towards~     vaccines when compared with young adults. Intradermal administration of vaccine has been~     suggested to improve immune response due to the abundance of immunostimulatory cells, such as~     dendritic cells in the dermis. Intradermal administration of influenza vaccine has been shown~     to have comparable or superior efficacy compared with intramuscular administration in the~     >60-year old population and the rates of adverse events post-vaccination were also comparable~     between them. The immunogenicity of intradermal administration has also been shown to be~     better in immunocompromised patients, including community dwelling older adults. In addition,~     intradermal vaccination has good acceptability and safety profile in different countries, so~     it has been licensed in Hong Kong and worldwide. However, there is little study regarding the~     efficacy of intradermal vaccination of influenza in institutionalized older adults,~     investigators therefore would like to perform a prospective, randomized study to compare the~     safety and immunogenicity between conventional full dose intramuscular immunization and full~     dose intradermal immunization of the trivalent influenza vaccine in institutionalized older~     adults.~      The hypothesis is that full dose intradermal trivalent influenza vaccination is as effective~     as full-dose standard intramuscular injection in terms of seroconversion and seroprotection~     rate in institutionalized older adults. Finding of this study will be important in the~     vaccination of institutionalized older adults and immunocompromised patients as intradermal~     vaccine may induce a better immune response against influenza infection.~   "
122249|NCT01967355|"~     Preeclampsia is a disease which occurs in about 6-8% of all pregnancies and is the main cause~     of maternal and fetal morbidity and mortality. The cause of preeclampsia is still not clear~     and the only therapy is preterm caesarean section. In severe preeclampsia an accumulation of~     triglyceride-rich lipoproteins occurs. Therefore, lipid apheresis is performed as~     lipid-removing therapy for treatment of preeclampsia in order to prolong pregnancy and~     provide the fetus more time for maturation. In this individual treatment patients with early~     preeclampsia (<= 32 weeks of gestation) will be offered a H.E.L.P.-apheresis to postpone~     caesarean section and therefore prolong pregnancy.~   "
122250|NCT01967342|"~     Chronic pain is a significant public health problem that affects over 116 million Americans,~     costs $600 billion annually, and is unequally borne by people in low-income brackets,~     especially ethnic minorities. Many individuals also have health literacy deficits (difficulty~     understanding their illness and difficulty navigating the health care system for treatment)~     putting them at a greater disadvantage. Treatment usually relies on expensive medical~     interventions that often have negative side-effects. Psychosocial treatments, like Pain~     Education and Cognitive-Behavioral Therapy (CBT), show promise, but are usually unavailable.~     Clinicians are poorly equipped to provide psychosocial treatments to patients with low health~     literacy. CBT has not been adapted and supported for use in individuals with low health~     literacy, and even educational materials are often poorly adapted for their needs.~      To address this problem, the PI completed a small trial showing benefits from health~     literacy-adapted pain education and CBT groups for chronic pain in a population with low~     income and low health literacy. Patients in both treatments reported lower pain by the end of~     treatment, and the effects were maintained at one year. Patients in the CBT group also~     reported less depression. The current study uses a larger sample, and directly compares these~     psychosocial treatments to medical treatment-as-usual to seek better evidence for or against~     their widespread use in community settings.~      Our research questions:~        1. In people with chronic pain and low income and/or low literacy, does participating in a~          health-literacy-adapted psychosocial treatment improve their pain and interference in~          daily activities due to pain by the end of treatment when compared with a group~          receiving typical medical care, and are these effects maintained 6 months later?~        2. Does participation in the CBT pain management group improve symptoms of depression~          better than a pain education group by the end of treatment, and are these effects~          maintained 6 months later?~      In partnership with a federally qualified health center, we will enroll 294 patients with~     chronic pain. Main outcomes will be patient-reported pain intensity, pain interference,~     depression, and perceived change. From an earlier trial, we expect that our participants will~     be ~75% female and ~70% African American, and will have low literacy and low income (~60% in~     the low 15% nationally on word reading, and 90% at or below the poverty threshold).~   "
122251|NCT01967329|"~     The CANHelp Working Group Treatment Trials are part of a comprehensive research program~     carried out by the Canadian North Helicobacter pylori (CANHelp) Working Group. The treatment~     component involves a series of community-specific trials designed with community input and~     varying on the specific treatment regimens and number of treatment arms among other study~     details.~   "
122252|NCT01967303|"~     Our study aimed to examine a possible association between Restless legs syndrome and~     cerebrovascular disease, by examining patients during hospitalization for acute stroke or~     transient ischemic attack, in a matched case-control design.~   "
122403|NCT01965327|"~     Friedreich ataxia (FRDA) is a progressive neurodegenerative disease of children and adults~     for which there is presently no therapy. Recently, a study reported that interferon gamma~     (IFN-g) could raise frataxin protein levels in both cell lines derived from patients with~     Friedreich ataxia and in a mouse model with Friedreich ataxia. The present study will test~     whether IFN-g is safe, tolerated and potentially efficacious in a heterogeneous cohort of~     children with FRDA.~   "
122253|NCT01967290|"~     The objective of this study is to determine the impact of vibratory feedback on the quality~     and intensity of a common motor rehabilitation task of the upper-arm (hand-to-mouth) in~     stroke patients. For that purpose the investigators use the SWORD system that combines 3D~     motion quantification wearable sensors and a vibratory module.~      The investigators hypothesize that vibratory stimuli during a motor rehabilitation task~     increase significantly the number of correct movements performed per unit of time.~      The design of the study is a cross-over randomized clinical trial. With the SWORD system in~     place each patient will perform the hand-to-mouth task twice (with vibratory feedback and~     without it), the order being random. The number of correct movements and other motor outcomes~     will be assessed continuously under both conditions.~   "
122254|NCT01967277|"~     This study will acquire data on hair growth of the head that is the result of treatment with~     a non-heat generating, laser product. This data will come from counting of terminal hairs~     before treatment begins and after treatment is completed. The treatment regime is every other~     day for 16 weeks.~   "
122255|NCT01967264|"~     The purpose of this study is to evaluate the safety and tolerability of Udenafil 150 mg~     compared to placebo.~   "
122256|NCT01967251|"~     The purpose of this study is to evaluate the efficacy, dose-response and safety of udenafil~     25 mg, 50 mg and 75 mg every day (q.d.) for 12 weeks in the treatment of lower urinary tract~     symptoms (LUTS) associated with benign prostatic hyperplasia (BPH and for the treatment of~     erectile dysfunction (ED).~   "
122257|NCT01967238|"~     In order to produce better more effective vaccines, it is important to understand the~     particulars of why individuals have an effective or ineffective immune response to~     vaccination. We are going to examine specific aspects of the antibody (IgG Fc glycan) made by~     healthy volunteers who receive different vaccines or who have a viral infection to understand~     the nature of an effective (or less effective) vaccine response. The results of this research~     could be used to develop adjuvants to increase/ improve vaccine response.~   "
122258|NCT01967225|"~     The aim of this study is to see the safety and efficacy of BAY1192631 when it is used for the~     treatment of skin and soft tissue infections (SSTI) or SSTI-related bacteremia.~   "
122259|NCT01967212|"~     The purpose of this study is to determine whether swallowing training combined with~     game-based biofeedback is effective in the treatment of dysphagia due to stroke.~   "
122260|NCT01967199|"~     The purpose of this study is to establish the safety and effectiveness of paclitaxel eluting~     balloon (SeQuent Please) compared to coronary stenting with the Everolimus-eluting balloon~     expandable stent (Xience Prime or Xience Xpedition or Xience Alpine) in the treatment of drug~     eluting stent restenosis.~   "
122261|NCT01967186|"~     Islet transplantation is a promising treatment of type 1 diabetes in selected cases. Results~     are however hampered by a relatively low number of islets surviving the transplantation into~     the liver, which currently is the site for transplantation. In the present study we compare a~     new transplantation site (intramuscular in the arm) to the golden standard (the liver) in~     patients undergoing kidney transplantation from the same donor. In half of the intramuscular~     transplanted patients, the islets will be mixed with mesenchymal stemcells from the recipient~     to, possibly, improve the immunological aspects of the transplantation.~   "
122262|NCT01967173|"~     The purpose of this study is to find the best asthma treatment to add for Blacks who have~     asthma that is not well controlled on a low dose of inhaled steroid. This study will also try~     to find out if Black adults and children differ in how they respond to the medications used~     in this study.~   "
122263|NCT01967160|"~     A non-interventional study to assess incident rates of Osteonecrosis of the Jaw and~     Infections leading to hospitalization in Cancer patients treated with XGEVA™ in Sweden,~     Denmark and Norway.~   "
122264|NCT01967147|"~     The purpose of this study is to demonstrate the superior efficacy of Systane® Balance over~     Preservative-Free 0.9% Saline following 35 days of QID (4 times a day) dosing in treating dry~     eye subjects with lipid deficiency.~   "
122265|NCT01967134|"~     This is a Phase I, open-label, dose-escalation study with three study groups. This study will~     be conducted in 25 HIV negative subjects, 17 of whom will have LTBI and 8 of whom will not~     have LTBI at study enrollment. The investigational product is AERAS-456 at a dose of 15 ug of~     H56 antigen with IC31 500 nmol KLK (15/500), and a dose of 50 ug of H56 antigen with IC31 500~     nmol KLK (50/500). The vaccine is administered by intramuscular injection.~   "
122266|NCT01967121|"~     The purpose of this research study is to determine if the application of ice, control group,~     or a muscle stimulation program from the Compex® series can help reduce or eliminate delayed~     muscle soreness from performing leg extension and flexion. Individuals will complete a health~     history questionnaire to determine if they qualify for this study. We will measure your leg~     girth with a measuring tape and take a pain measurement of your hamstrings by using a spring~     to press down on your leg. Individuals will then warm-up on a bike without resistance for 5~     minutes followed by 10 regular leg extension and flexion exercises. Individuals will then~     perform 6 sets of 10 leg extension and flexion exercises on a biodex machine (similar to leg~     curl machines in the gym). Individuals will perform each set to the maximum effort of their~     capables. After each set of 10 individuals will have a 2 minute rest. We will ask you to rank~     your leg soreness on a scale from 1-10.~      Individuals will then be assigned to a modality of either ice, control group or compex.~     Individuals will perform the modality (ice, control, compex) we assign you to until you are~     no longer sore.~      Over the next five days individuals will return to measure their level of soreness, leg girth~     and pain pressure.~      This study will examine the following hypotheses:~      H1: There will be no difference in pressure pain threshold after using the Compex compared to~     other groups.~      H2: There will be no difference in perceived soreness after using the Compex compared to~     other groups.~      H3: There will be no difference in muscular strength after using the Compex compared to other~     groups.~      H4: There will be no difference in active range of motion after using the Compex compared to~     other groups.~   "
122267|NCT01967108|"~     The purpose of this study is to examine the efficacy of chest physiotheray treatment in~     preventing pulmonary complications and weaning faliure, in extubated critically ill patients.~   "
122821|NCT01959854|"~     The purpose of this study is to evaluate the effect of an ophthalmic solution containing 0.2%~     xanthan gum in reducing symptoms and signs of dry eye as well as tear film markers of~     oxidative stress.~   "
122268|NCT01967095|"~     The purpose of this study is to test the safety of different ways of taking erlotinib. The~     investigators want to find out what effects, good and/or bad, combination daily low dose and~     twice weekly high dose erlotinib has on the patient and lung cancer. The investigators are~     also seeing whether different schedules of erlotinib are better at treating lung cancer that~     has spread to the central nervous system.~      CNS expansion phase:~      The pulse continuous regimen will be then assess in patients with EGFR mutant lung cancers~     and CNS involvement. An additional expansion cohort (A) will enroll 19 patients with newly~     diagnosed EGFR mutant lung cancer with CNS involvement at diagnosis. The patients in the~     expansion cohorts will undergo the same treatment plan as the patients in the dose expansion~     cohort. A patient in the expansion cohorts will not be replaced if he/she does not finish the~     first 28 day (cycle 1) treatment period.~   "
122269|NCT01967082|"~     Objectives:~      The specific aim is to investigate the following objectives:~      Objective 1.1: Develop a prototype of the APPSPIRE (phone app of a smoking prevention~     interactive experience).~      This objective will not involve any data analysis. Objective 1.2: At post assessment,~     students enrolled in the study will qualitatively provide information about the usability and~     usefulness for the prevention and cessation sites.~      Objective 2.1: Investigate frequency of use of and exposure to APPSPIRE modules via an~     objective measure of general use.~      Objective 2.2: Investigate how feasible the program will be. Feasibility will be~     operationalized for this objective. Objective 2.3: Obtain a maintained use of APPSPIRE with~     high completeness and extent of completion.~      Objective 2.4: Evaluate change in stage of change from baseline to about 1 and 4-month~     follow-ups among participants.~   "
122270|NCT01967069|"~     The objectives of this study are to compare the efficacy and safety of DFD01 Spray to Vehicle~     Spray for topical treatment of moderate plaque psoriasis~   "
122271|NCT01967056|"~     Respiratory failure following extubation causes significant morbidity and increases mortality~     in teh surgical intensive care unit (SICU). However the causes of respiratory failure~     following extubation remain poorly understood. The investigators hypothesize that extubation~     failure can be predicted based on preoperative risk factors as well as ICU acquired~     morbidities including muscle weakness and renal failure.~   "
122272|NCT01967043|"~     This is a standard 3+3 Phase 1b study to determine the MTD of Oraxol (paclitaxel + HM30181~     Methanesulfonate monohydrate) in subjects with advanced malignancies that may be metastatic~     or unresectable with measurable malignant lesion(s) per RECIST Version 1.1 criteria.~   "
122273|NCT01967030|"~     The goal of the Study of Women, Infant Feeding and Type 2 Diabetes after GDM pregnancy~     (SWIFT) is to determine whether exposure to prolonged, intensive lactation, as compared to~     formula feeding, reduces the 2-year incidence of type 2 diabetes mellitus among 1,035 women~     with a recent GDM pregnancy. The study will also examine whether lactation intensity and~     duration have persistent favorable effects on blood glucose, insulin resistance, weight gain,~     change in waist circumference, and adiposity during the two-year postpartum period. SWIFT is~     a prospective, longitudinal observational study in women at high risk for conversion to~     diabetes and prediabetes during midlife.~   "
122274|NCT01967017|"~     Despite the high efficacy of intrauterine devices (IUDs), some women choose not to receive~     IUDs secondary to the pain associated with insertion. Nulliparous women may be especially~     susceptible to procedure-related pain from IUD insertion. This study will investigate the~     difference in perceived pain from IUD insertion, comparing local anesthesia to a placebo,~     among women who have not had a vaginal delivery before. The investigators anticipate that~     among women who have not had a previous vaginal delivery, the pain associated with IUD~     insertion will be significantly decreased after administration of local anesthesia.~   "
122275|NCT01967004|"~     The purpose of this study is to determine if Radio Frequency Identification (RFID) can lead~     to greater prosthesis function and control. Subjects are asked to perform specific tasks and~     actions using the traditional control method, as well as RFID control.~   "
122276|NCT01966991|"~     This study will explore how maternal plasma circulating cell free DNA (ccfDNA) can be used as~     a primary screening test for Down syndrome as part of routine clinical care in the general~     pregnancy population. Plasma ccfDNA testing is currently recommended only for use as a~     secondary screen for 'high-risk' women (i.e., women whose risk factors for trisomy make them~     candidates for invasive testing such as chorionic villous sampling or amniocentesis). Because~     most women in this 'high-risk' category are carrying unaffected fetuses, many 'unnecessary'~     procedures are completed in order to identify the few women whose fetuses have a chromosomal~     disorder. This creates expense, anxiety, and most importantly, loss of unaffected fetuses due~     to procedure related miscarriage. Plasma DNA testing is now being used to reduce~     significantly the number of women with unaffected fetuses undergoing invasive testing.~      Applying such testing as a 'first-line' screen has not been well-explored, despite calls from~     several clinical professional societies to do so. The investigators intent is to introduce,~     under carefully monitored conditions, ccfDNA testing through Rhode Island primary prenatal~     practices to the general pregnancy population. Education/orientation of prenatal care~     providers, their staffs, and their patients will be carefully orchestrated, and~     implementation issues identified and addressed. Telephone surveys of consented patients will~     elicit responses to their understanding of the test, their satisfaction with the process, and~     a comparison of their experience with serum screening in a prior pregnancy. Knowledge gained~     from this study will help validate new screening paradigms involving ccfDNA testing. The~     study is not designed to estimate Down syndrome detection rates with any confidence, but can~     provide information on uptake rates, failure rates, screen positive rates, and the~     decision-making of women with positive test results.~   "
122277|NCT01966978|"~     The aim of this clinical trial is to assess and compare the effect of insulin detemir in~     combination with liraglutide and metformin versus insulin detemir in combination with insulin~     aspart and metformin in subjects with very uncontrolled Type 2 Diabetes (A1c > 10%).~   "
122278|NCT01966965|"~     This study aims to demonstrate the therapeutic efficacy and safety of Shampoo PIOLIN ® in the~     treatment of human pediculosis. Will be treated 212 patients aged 2-60 years with the~     infestation, along with the people in your family life. All will be submitted to the dosing~     regimen recommended in the package insert. 100% of the sample shall be subjected to clinical~     evaluation through comb, pre and post treatment and monitored after thirty days for~     evaluation of safety and possible adverse effects that may arise related to any of the~     components of the formula.~      The efficacy study is active comparator, non-inferiority.~   "
122494|NCT01964131|"~     The purpose of this study is; To investigate whether a D961H sachet 20 mg is bioequivalent to~     a D961H HPMC capsule 20 mg by the assessment of percentage of time with intragastric pH>4.~      To compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg by the assessment of~     percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH.~      To compare PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg.~      To evaluate the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg.~   "
122279|NCT01966952|"~     Renal sympathetic radioablation disrupts the nerves by high radiofrequency signal which~     creates localized heat, eliminates the signal and decrease blood pressure.~      The main purpose of this study is to evaluate blood pressure 12 months after radioablation,~     and to evaluate the short and long-term effects of the renal radioablation on the extent of~     changes in urine catecholamines level, vascular stiffness, and sympathetic nerve activity as~     linked with the changes in blood pressure. The study will also evaluate the effect~     radioablation has on the renal arteries as well as develop teaching sessions for family~     physicians and other specialists to educate them on this new treatment.~   "
122280|NCT01966939|"~     There are two purposes on this study:~      - to investigate the effect of craniectomy and craniotomy on temporomandibular joint TMJ)~     movement, function and quality of life (QoL)~   "
122281|NCT01966926|"~     Scant data have been reported on the effects of weight self-monitoring during weight control.~     The purpose of this pilot project was to consider the questions: Is it possible to assign~     participants to engage in daily weight self-monitoring, and are there differential effects on~     mood of daily versus weekly weighing?~   "
122282|NCT01966913|"~     High-dose chemotherapy with autologous hematopoietic stem-cell transplantation is a standard~     salvage treatment used in adults with germ cell tumors (Einhorn et al, J Clin Oncol 2007).~      Disease prognosis following 1 to 2 intensified combinations of etoposide - carboplatin +/-~     ifosfamide depends on the patient's performance status (PS) at inclusion and the prior~     sensitivity of the disease to cisplatin. A poor PS and/or being refractory to cisplatin~     suggest a higher toxicity and a bad prognosis.~      However, predictive factors of response to high-dose chemotherapy do not include a~     chemo-sensitivity phase with a semi-intensive chemotherapy excluding a platinum compound~     (epirubicin - paclitaxel), which still allows stem-cell harvest. The use of this chemotherapy~     combination induced a response in more than one third of the patients treated during disease~     progression in the TAXIF I study. The same strategy was tested in the TAXIF II study, which~     completed the inclusion of 45 patients and was closed in May 2008. Results of the TAXIF II~     study, are currently being analyzed; they support the hypothesis to prioritarily treat~     patients with a sensitive relapsed disease at the time of the high-dose administration.~      A combination of a semi-intensive sequential ICE type chemotherapy plus bevacizumab was used~     on a highly refractory patient. A 5 months nearly complete response was achieved. Indeed, the~     overexpression of VEGF (Vascular Endothelial Growth Factor) has been identified as an~     independent risk factor in patients with germ cell tumor. Therefore, a treatment strategy~     using an inductive chemotherapy followed, in case of response, by a double intensification~     therapy in combination with a VEGF treatment, could be an interesting approach in patients~     with poor prognosis germ cell tumors.~      The aim of this phase I/II trial is to assess the feasibility of a Bevacizumab - ICE~     (Ifosfamide-Carboplatin-Etoposide) high dose combination with the support of autologous~     hematopoietic stem cell for two intensive consecutive cycles (tandem intensification) in~     patients with a poor prognosis germ cell tumor non refractory to a front-line mobilization~     chemotherapy using two half intensified consecutive combinations of Epirubicin-Paclitaxel.~   "
122283|NCT01966900|"~     The potential HIV vaccine has two components: a protein immunogen based on the coat protein~     of HIV; and an adjuvant which enhances the vaccinee's response to the immunogen. The~     immunogen is CN54gp140, and the adjuvant is glucopyranosyl lipid adjuvant - aqueous~     formulation (GLA-AF).~      We wish to assess the vaccine's safety and immunogenicity (the nature of the immune response~     stimulated by the vaccine) when it is given in two different dose regimens:~      Group A: vaccinations at Months 0, 1, 2 and 6; and Group B: vaccinations at Months 0, 1, 2~     and 12.~      Each dose will be an intramuscular injection of 100 micrograms of CN54gp140 mixed with 5~     micrograms of GLA-AF.~      We will recruit only healthy, HIV-uninfected men and women. We will assess the safety of the~     vaccine by monitoring the occurrence of adverse events in the participants. We will assess~     the immunogenicity of the vaccine by monitoring the immune response to the vaccine in blood~     and in genital mucosal secretion samples.~   "
122284|NCT01966887|"~     The purpose of this study is to determine the effect of intracoronary SERCA2a Gene transfer~     on cardiac volumes and function using multimodality cardiac imaging.~   "
122285|NCT01966874|"~     The purpose of this study is to determine the efficacy and acceptability of a regimen of 200~     mg mifepristone (Zacafemyl), followed 24-48 hours later by 800 mcg of buccal misoprostol.~   "
122286|NCT01966861|"~     The present study aims to evaluate the impact of a weaning strategy based on identification~     of early signs of respiratory distress by lung ultrasound and the consequent implementation~     of a clinical optimization protocol as compared to usual care.~   "
122287|NCT01966848|"~     In the history of TKA several different types of prosthetic designs have been evolved in~     order to optimize knee function after total knee replacement. The most common difference~     between the prosthetic designs revolves around issues concerning the preservation of the~     cruciate ligaments. The most popular prostheses have been the posterior stabilized prosthesis~     (PS) in which both cruciate ligaments are resected and the posterior cruciate retaining~     prosthesis (CR) in which only ACL is resected and PCL is preserved. Both these prosthetic~     designs have shown excellent clinical results in the literature.~      In the knee the role of the cruciate ligaments is to insure anterior/posterior stability, but~     studies have also shown, that the cruciate ligaments contain proprioceptive mechanisms which~     control joint kinematics essential for accurate knee function. One could therefore imagine~     that a prosthetic design that preserves both cruciate ligaments would be superior to~     prosthetic designs in which ACL or ACL/PCL is resected in achieving good clinical results and~     patient satisfaction.~      Only a few prosthetic designs, which preserve both cruciate ligaments, have been available to~     the market. However studies based on fluoroscopic assays and gait analysis has shown that~     this prosthetic design is superior to cruciate sacrificing designs in preserving normal knee~     kinematics during activities of daily living after TKA. Studies, in which patients have~     received two different types of prosthesis in each knee, have also shown that bi-cruciate~     retaining TKA's is preferred, when compared to more constrained prosthetic designs.~      The new Vanguard XP TKA system (Biomet®, Warsaw, Indiana, USA) is a further development of~     the Vanguard TKA system, which has shown good clinical results in earlier studies. With the~     new Vanguard XP system both cruciate ligaments are preserved. In theory this should result in~     a more natural feeling of the knee because the stability and proprioceptive signals from both~     cruciate ligaments are preserved. In order to investigate the potential benefits of this new~     prosthetic design, the clinical and radiological results of knees receiving a Vanguard XP and~     Vanguard CR prostheses are compared.~      In this study we wish to investigate:~        1. If the use of the Vanguard XP prosthesis will influence the migration of the femur- and~          tibial components measured by Radiostereometric Analysis (RSA) when compared to the~          Vanguard CR prosthesis.~        2. If the use of the Vanguard XP prosthesis will result in increased participant knee~          function, satisfaction and quality of life when compared to the Vanguard CR prosthesis.~        3. If the use of the Vanguard XP prosthesis will influence radiologic signs of osteolysis,~          complication rates and revision rates when compared to the Vanguard CR prosthesis.~      This project is carried out as a randomized controlled double-blinded trial, in which the~     clinical and radiological outcomes after treatment of knee osteoarthritis with insertion of~     either a Vanguard XP or Vanguard CR prosthesis is compared.~   "
122288|NCT01966835|"~     Poor sleep quality and sleep disturbances are common in patients with rheumatoid arthritis~     and are associated with an increased risk of co-morbidity and all-cause mortality.Few studies~     have examined the possibilities of improving sleep in patients with rheumatoid arthritis, and~     the focus has primarily been on medical treatment. Aerobic exercise training constitutes a~     potentially promising, non-pharmacological alternative to improve sleep.~      This study is a randomized controlled trial of 44 patients with rheumatoid arthritis.~      The aim is to investigate the effect of a moderate-to-high intensity aerobic interval~     training intervention on sleep quality and sleep disturbances in patients with rheumatoid~     arthritis.~      The primary hypothesis is that moderate-to high intensity aerobic exercise will improve~     objective measured sleep quality and sleep disturbances. The secondary hypothesis is that the~     intervention may improve fitness, subjective sleep quality and physical function as well as~     reduce pain, fatigue, depressive symptoms and improve health-related quality of life.~   "
122495|NCT01964118|"~     The purpose of Intermittent Fasting study is to investigate whether intermittent fasting~     could decrease the chronic inflammation levels in overweight/obese people.~   "
122289|NCT01966822|"~     Protease inhibitors (PI) have been associated with an acceleration of bone mineral density~     loss in HIV-infected individuals because of an enhanced osteoclast activity, although some~     controversial data have been also published. A first study suggest an increase of bone~     mineral density after switching from PI to raltegravir, the first generation integrase~     inhibitor, but there are no more data about this subject.~      Based on data that PI decrease bone mineral density by accelerating osteoclast cells and that~     the discontinuation of this drugs could improve bone mineralization, we propose a randomized~     prospective multicenter study to assess the impact of switching from PI to dolutegravir on~     bone mineral density in patients with low bone mineral density receiving a PI-containing~     regimen. At the same time, the study will help to assess the antiviral efficacy and safety of~     a PI-sparing regimen including dolutegravir as a simplification strategy in virologically~     suppressed patients.~   "
122290|NCT01966809|"~     This study will be aimed at investigating the effectiveness of a treatment for brain tumors~     called Photodynamic Therapy, or PDT. Briefly, a subject will receive a light-sensitive drug,~     called Photofrin®, the day before a tumor removal surgery. The next day, after the tumor is~     removed, red light from a laser will be shone into the tumor cavity through a light-diffusing~     sphere. This light will activate the photosensitizer, and possibly kill any tumor cells that~     may be left.~      We plan to measure how long the subject may go without a new tumor regrowth, and overall how~     long subjects survive. We will compare these results to typical results to see if we are~     seeing any improvements.~      Objective: To define the antitumor activity of Photofrin® and laser light activation within~     the confines of a Phase II study.~   "
122291|NCT01966796|"~     Background The prediction of multi-drug resistant (MDR) pathogens is a key issue in the~     management of health-care associated pneumonia (HCAP). Multiple risk factors have been~     proposed, some of which overlap with items of the pneumonia severity index (PSI). The aim of~     this study was to investigate the relationship between PSI and presence of MDR pathogens.~      Methods Patients who were admitted to a tertiary-care hospital from January 2005 to December~     2010 were screened by a discharge diagnosis of pneumonia. Patients were enrolled if they~     fulfilled the definition of HCAP by 2005 ATS/IDSA guideline.~   "
122292|NCT01966783|"~     The purpose of this study is to investigate the efficacy and safety of budesonide suppository~     for the treatment of acute ulcerative proctitis.~   "
122293|NCT01966770|"~     The aim of this fitting study is to evaluate the clinical performance of different hydrogel~     and silicone hydrogel contact lenses.~   "
122294|NCT01966757|"~     Neuronal Ceroid Lipofuscinosis (NCL) also known at Batten's disease is the most common~     neurodegenerative disorder in children. Families often report the patient has a sleep~     disturbance. This is a questionnaire to be completed by the family to better understand the~     sleep pattern and sleep difficulties experienced by individuals who have been diagnosed with~     NCL.~   "
122295|NCT01966744|"~     The purpose of the study is to develop, evaluate, and optimize an interactive website (the~     SMART portal). The SMART portal will use IBD-specific and general assessments and~     interventions to reduce the burden of common barriers to treatment adherence and enhance~     self-management skills. This study aims to build and revise the SMART portal according to~     feedback and testing from participants.~   "
122296|NCT01966731|"~     REACH is a prospective, phase I/II open-label dose escalation trial of hydroxyurea for~     children with confirmed SCA between 12 months and 10 years of age. The short-term goal is to~     obtain critical pilot data regarding the feasibility, safety, and benefit of hydroxyurea for~     children with SCA in multiple distinct research settings in Africa. Based on that~     information, the longer-term goal is to make hydroxyurea more widely available for children~     with SCA in Africa, particularly those identified with SCA through expanded newborn screening~     programs.~   "
122297|NCT01966718|"~     It is hypothesized that repository corticotropin injection in combination with other biologic~     agents will be able to provide relief of both rheumatoid arthritis and acute exacerbations of~     rheumatoid arthritis for patients with disease that had inadequately responded to biologics~     previously.~   "
122298|NCT01966705|"~     Background~      Severe health anxiety, Somatic symptom disorder or Illness anxiety disorder according to the~     Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5), is associated with~     considerable personal distress, functional disability and societal costs. Several studies~     have demonstrated the efficacy of Cognitive Behavior Therapy (CBT) for severe health anxiety,~     both on anxiety itself and on secondary symptom measures (for example of depression). One~     published randomized controlled trial (RCT) has examined the feasibility of delivering CBT~     for severe health anxiety via the Internet as a form of guided self help. Participants had~     contact with a therapist via an e-mail-like system throughout the treatment. This approach~     yielded results superior to a waiting-list condition, thus potentially greatly increasing the~     availability of psychological treatment. However, more studies on the effects of~     Internet-delivered CBT are warranted (NCT01673035 being one). Additionally, little is known~     about the active ingredients and mechanisms of change involved in Internet-delivered CBT. For~     example, the significance of therapist support in relation to treatment outcomes remains to~     be determined. CBT-based self-help literature, so called bibliotherapy, has shown great~     promise in the treatment of several anxiety disorders, including panic disorder and social~     anxiety disorder. Two small pilot studies have indicated that bibliotherapy with no or~     minimal therapist contact could be suitable for treating health anxiety.~      Aim of the study~      The aim of the present RCT is to compare therapist-guided Internet-delivered CBT (n=33),~     Internet-delivered CBT without therapist guidance (n=33), CBT-based bibliotherapy without~     therapist guidance (n=33) and a waiting-list control condition (n=33) for adult participants~     with severe health anxiety.~      Participants in all treatment programs are expected to be significantly improved on measures~     of health anxiety, compared to participants allocated to the waiting-list condition.~   "
122299|NCT01966692|"~     When a drug company first develops a drug, the company has to show the Food and Drug~     Administration (FDA) that the drug is safe and effective. If FDA concludes that the drug is~     safe and effective, FDA approves the drug. The company can then sell the drug, which the~     company does using trade name. Only the drug company that developed the trade name drug~     is allowed to sell it. However, other drug companies can create their own version of the~     trade name drug, which usually happens after the patents for the trade name product run~     out. These drugs, often called generic drugs, potentially will be less expensive for the~     patient. In order to sell generic drugs, drug companies must show that their generic version~     is the same as the trade name drug in a number of ways. For example, they generally have to~     show that their product is intended to be used to treat the same diseases or conditions, that~     it has the same label, and that the product has the same active ingredient as the trade~     name drug. The generic company also has to show that generic product is bioequivalent to~     the trade name drug, meaning that the generic product gets to the part of the body where the~     drug works at the same rate that the trade name drug does. How to show how much drug gets to~     the part of the body where it works, and how fast, depends on the type of product the drug~     is. The primary aim of this research study is to aid the FDA in finding methods to ensure~     that the versions of generic drugs that are inhaled (for example, drugs used to treat asthma)~     are bioequivalent to the trade name drug. As a part of the research study, pharmacokinetic~     (PK) studies (studies measuring drug levels in the blood over time after inhalation) will be~     done using three different versions of fluticasone propionate (FP, a drug routinely used in~     asthmatic patients) administered using a dry powder inhaler (DPI, an inhalation device that~     delivers the drug as a dry powder). The results from this study will help FDA ensure that~     generic products are the same as the trade name drugs.~   "
122822|NCT01959841|"~     To evaluate the efficacy and safety of ASP2151 (200 mg and 400 mg) in comparison with~     valaciclovir (VACV) 3000 mg in patients with herpes zoster.~   "
122300|NCT01966679|"~     This study is a NIMH-funded multi-site clinical trial that includes UCLA as the coordinating~     site, with Emory University and Seattle Children's Hospital, as other recruiting sites, and~     the Nathan Kline Institute as the Data Management Center. The purpose of the study is to~     examine the effects of an investigational drug, AZD7325, as a potential treatment for~     high-functioning adults 18 -35 years old with Autism Spectrum Disorders (ASD). The primary~     study measures are effects on brain waves as measured by non-invasive brain wave recordings~     (electroencephalograms or EEGs), assessments of side effects, and measures of attention and~     learning.~      The study drug, AZD7325, is manufactured by Astra Zeneca, and was initially tested as a~     medication for anxiety disorders in over 488 subjects, but was not pursued for marketing due~     to too few benefits for anxiety. AZD7325 was found to have a very good safety profile and was~     tolerated by the majority of subjects. AZD7325 has some similar actions to currently marketed~     anxiety drugs in the benzodiazepine class, but lacks the sedative and negative effects on~     attention of the benzodiazepines. The study drug is designed to target the GABA~     neurotransmitter system which is believed to be abnormal in this population.~      There are 2 study phases. Phase 1 includes the recruitment of 24 healthy volunteers without~     mental disorder (6 per site) in order to establish normal EEG reference ranges. Controls will~     only be seen for one study visit which includes a clinical evaluation, physical exam, routine~     blood tests, and an EEG. Once control recruitment is complete, Phase 2 will begin.~      Phase 2 involves the recruitment of 40 adults (10 per site) 18 - 35 years old with a~     diagnosis of ASD, normal intelligence, and specific EEG patterns compared to control values.~     Screening for eligibility will be performed in one visit, which includes a clinical~     evaluation, tests of learning and intelligence, blood and urine tests, and an EEG. Those~     subjects who are found to be eligible will be enrolled in a 6-week medication study. Subjects~     with ASD who are enrolled will be randomly assigned to receive the study drug AZD7325 or~     placebo in matching capsules. Subjects will be seen weekly by study physicians and clincians~     for the 7 study visits, including 3 additional EEG recordings, and then for a final follow-up~     visit (9 total visits including screening lasting up to 11 weeks to complete). Study~     physicians can adjust the dose of study medication to reduce any side effects.~   "
122301|NCT01966666|"~     The purpose of the study is to determine the highest dose of TPI-287 that is safe and~     tolerable when administered as an intravenous infusion to participants with mild to moderate~     Alzheimer's disease (AD), to measure pharmacokinetic properties of the drug as well as to~     gauge preliminary efficacy of TPI-287 on disease progression.~   "
122302|NCT01966653|"~     Developed before the establishment of a structured process for drug assessment,~     nitrofurantoin is now being prescribed frequently given the rise in multi-resistant~     gram-negative pathogens. Doubts remain regarding fosfomycin's long-term clinical~     effectiveness. A randomized, controlled trial is needed to explore the clinical effectiveness~     and better define the side effect profiles of both nitrofurantoin and fosfomycin. This~     multi-center open trial will randomize 600 non-pregnant women at three international sites~     (200 each in Poland, Switzerland, and Israel) at increased risk for carriage of resistant~     uropathogens and with suspicion of uncomplicated lower urinary tract infection to receive~     either oral nitrofurantoin 100 mg three times daily for 5 days or a single 3g dose of oral~     fosfomycin. Patients will be followed for clinical and bacteriologic response at days 14 and~     28 post therapy completion. The study hypothesis holds that nitrofurantoin will be superior~     to fosfomycin in clinical efficacy at final follow-up.~   "
122303|NCT01966640|"~     Child food allergy represent 6 to 8% of child in industrialised country. Within this allergy,~     peanuts and egg allergy are one of the most common.~      Actually when there is a suspicion of food allergy, the OPT is the gold standard for the~     diagnosis. During the OPT we give increasing doses of the allergen to the patient and~     evaluate threshold causing a clinical reaction. This test is associated with a risk of strong~     allergic reaction and need a medical supervision.~      Standard allergy test, like skin test or specific IgE test, can't be use for the diagnosis of~     these allergy. Some publications demonstrate that these tests lack sensibility and~     specificity for child food allergy diagnosis.~      New tests have to be develop to diagnosis child food allergy without risks. The BAT is a~     cellular test able to evaluate the basophiles activation by specific allergen in vitro. This~     test allow us to evaluate more physiologically the sensitization of patients to an allergen.~     It is already used in drug allergy and it has been evaluated in infant milk allergy in an~     other clinical trial.~      In this study we want to evaluate the sensitivity of BAT to the diagnosis of child food~     allergy compare to the gold standard test OPT. We will evaluate the BAT on 140 children with~     food allergy and compare this results with the OPT at the same time. If the BAT results can~     predict the sensitivity of children to food allergen, it could limit the use of the OPT and~     reduce the risk of this test.~   "
122304|NCT01966627|"~     This is a study to investigate genetic predisposition to hepatic steatosis and the expression~     of gluconeogenic and lipogenic genes in livers of obese children and adolescents.~      Hypothesis 1: Common variants recently associated with variation in plasma TG levels~     identified in Genome Wide Association Studies (GWAS) (such as GCKR, PNPLA3) can affect~     accumulation of fat and subsequent development of Non Alcoholic Fatty Liver Disease (NAFLD).~     Gene variants act in additive or synergistic manner with progressive liver fat accumulation~     per additional risk allele.~      Hypothesis 2: With increase in hepatic fat content NASH and fibrosis will increase.~     Furthermore, expression of lipogenic markers (SREBP1c) will increase.~   "
122305|NCT01966614|"~     The purpose of this study is to evaluate the safety and efficacy of a single treatment of~     PRX302 for the treatment of Benign Prostatic Hyperplasia (BPH) as compared to placebo.~   "
122306|NCT01966601|"~     To evaluate the overall safety and efficacy of TRV027 when administered in addition to~     standard of care (SOC) on mortality, morbidity, dyspnea, and length of stay in patients~     hospitalized with Acute Decompensated Heart Failure (ADHF).~   "
122307|NCT01966588|"~     The purpose of this study is to find genes that predict whether or not a person will develop~     side effects to antipsychotic medications, such as weight gain, blood sugar dysregulation, or~     immune cell abnormalities. We will be collecting blood samples from participants who are~     taking second-generation antipsychotic medications. These blood samples will be stored over~     the long-term in a biobank, and will be used for later genetic testing and other cell-based~     studies.~   "
122308|NCT01966575|"~     Women with polycystic ovary syndrome (PCOS) can suffer from infertility because they do not~     produce an egg each month, resulting in irregular periods. As a result, these women often~     need a medication called clomiphene citrate (clomiphene) to induce ovulation. A traditional~     'clomiphene protocol' begins with a short course of progestin treatment to bring on a period~     (termed a 'withdrawal bleed') before starting the clomiphene medication. Newer evidence,~     however, has suggested that this progestin-induced shedding of the uterine lining (i.e.,~     withdrawal bleed) may decrease the chances of pregnancy. The purpose of our study is to~     determine whether withdrawal bleeding has an impact on pregnancy rates for patients with PCOS~     undergoing a clomiphene cycle.~      It is hypothesized that patients who undergo ovulation induction with clomiphene citrate~     without prior endometrial shedding will have higher clinical pregnancy rates than those who~     begin with a progestin-induced withdrawal bleed.~   "
122311|NCT01966536|"~     Women delay maternity and, as a consequence, available oocyte number and their quality~     decrease (9-18% of all IVF patients). Different treatment protocols have been developped~     nevertheless none of them optimal: the number of oocytes retrieved depends on the present~     ones. New generation of oocytes and follicles has been defended by some authors and bone~     marrow seems to be involved. What seems crucial is the niche that produces paracrine signals~     able to activate dormant cells and to attract undifferentiated cells from other tissues~     (homing). This phenomenon has been described by our group in other human reproductive tissues~     like endometrium. The purpose of the study is to improve ovarian reserve in unfertile women~     with poor ovarian reserve by means of bone marrow protective capacity.~      CD133+ cells obtained from bone marrow will be delivered into the ovarian artery allowing~     them to colonize ovarian niche.~      The study hypothesis is that CD133+ cells will improve ovarian reserve differentiating~     themselves into germ cells or, more likely, stimulating the niche to activate dormant~     follicles.~   "
122312|NCT01966523|"~     To conduct a pilot study of cluster randomized clinical trial of an practice intervention to~     improve the quality of care for suspected lower respiratory and and urinary tract infections~     among 60 nursing home residents with advanced dementia living in 4 facilities (2 matched~     intervention/control pairs) for 12 months. We hypothesize that 1. In the intervention~     compared to the control facilities there will be a trend towards a greater proportion of~     infections for which antimicrobials were initiated appropriately, and 2. in the intervention~     compared to the control facilities there will be a trend towards higher proxy satisfaction~     with decision-making, fewer hospital transfers, and lower antimicrobial exposure.~   "
122313|NCT01966510|"~     Indication: Patients with advanced lymphoid malignancies in the absence of an HLA identical~     or mismatch donor.~      Objectives: Overall survival at one year. Efficacy >60%, rejection rate <20%. Inclusion~     criteria: Age: 18-65 years old, no sibling or unrelated donor identified, low grade~     non-hodgkin lymphoma in third line (who already received at least one autologous~     transplantation); hodgkin lymphoma in early relapse (<1 year), who received at least one~     autologous transplantation and sensible to chemotherapy and CLL with 17p deletion or in~     relapse less than 2 year after a fludarabine nbased regimen or in relapse after one~     autologous transplantation.~      Stem cell source: Two cord blood units containing both together more than 3x107 frozen~     nucleated cells/Kg with no more than 2 out of 6 HLA mismatches between them and with the~     patients.~   "
122314|NCT01966497|"~     The main objective of this observational survey is to estimate the incidence, the typology,~     and the evolution of patients with acute myelobalstic leukemia, aged more than 60 years old.~     In this age group (aged more than 60y), three groups of patients with very different response~     rates and late outcome can be delineated with specific standard chemotherapy.~   "
122315|NCT01966484|"~     Succinylcholine is commonly used for neuromuscular relaxation for short procedures such as~     rigid bronchoscopy. A alternative is the application of low dose mivacurium, reversed with~     neostigmine. The investigators compare the intubating conditions, incidence of postoperative~     myalgia (POM), patient satisfaction and the postoperative performance with respiration~     exercise device for these two muscle relaxants.~   "
122316|NCT01966471|"~     This two-arm, randomized, open-label, multicenter study will evaluate the efficacy and safety~     of trastuzumab emtansine in combination with pertuzumab versus trastuzumab in combination~     with pertuzumab and a taxane as adjuvant therapy in participants with human epidermal growth~     (HER) factor 2 (HER2)-positive primary invasive breast cancer. Following surgery and~     anthracycline-based chemotherapy, participants will receive either trastuzumab emtansine at a~     dose of 3.6 milligrams per kilogram (mg/kg) and pertuzumab at a dose of 420 milligrams (mg)~     intravenously (IV) every 3 weeks (q3w) or trastuzumab at a dose of 6 mg/kg and pertuzumab at~     a dose of 420 mg IV q3w in combination with a taxane.~   "
122317|NCT01966458|"~     This is a prospective, randomized, controlled, unblinded, multi-center evaluation of safety~     and efficacy in patients implanted with a HeartWare® HVAD who receive improved blood pressure~     management. Subjects have chronic Stage D or NYHA Class IIIB/IV left ventricular failure who~     have received and failed optimal medical therapy, and who are ineligible for cardiac~     transplantation.~   "
122318|NCT01966445|"~     Human Epidermal Growth Factor Receptor 3 (HER3) expression is seen across a wide variety of~     solid malignancies and is associated with poor prognosis. Up-regulation of HER3 expression~     and activity is also associated with resistance to multiple pathway inhibitors. GSK2849330, a~     monoclonal antibody targeting HER3, is a new agent for subjects whose tumors express HER3.~     This study is a phase I, first time in human, open-label, dose escalation study. The purpose~     of this study is to investigate the safety, pharmacokinetics (PK), and pharmacodynamics (PD)~     of GSK2849330 in subjects with advanced HER3-positive solid tumors. The study will be~     conducted in two parts. Part 1 (Dose-Escalation Phase) will include dose escalation and PK/PD~     cohorts to evaluate safety, PK, and PD to guide selection of dose regimen(s) for Part 2. In~     Part 2 (Expansion Cohorts), up to 3 cohorts will be enrolled at the dose regimen(s) selected~     based on Part 1 data, to evaluate safety in a larger cohort of subjects at the recommended~     dose regimen and also to evaluate preliminary evidence of clinical benefit.~   "
122319|NCT01966432|"~     This add-on study of providing tobacco, alcohol and other drug screening, brief intervention~     and referral for treatment to a primary care high risk diabetic population leverages the~     existing research resources of a funded parent project Duke University CMS Innovation Award~     Southeastern Diabetes initiative (PI: Robert M. Califf, MD) to explore the feasibility of~     implementing Screening for substance use, Brief Intervention, and Referral to Treatment~     services in Primary Care (SBIRT-PC) and to examine the effects of substance use status on~     diabetes health care outcomes. This pilot study also examines the feasibility of the CTN's~     common data element algorithms of SBIRT for illicit and nonmedical drug use in the primary~     care setting.~   "
122320|NCT01966419|"~     The purpose of this study is to determine whether ornithine phenylacetate can speed recovery~     from an acute hepatic encephalopathy episode requiring hospitalization in cirrhotic patients.~   "
122496|NCT01964105|"~     The purpose of this trial is to evaluate the impact of incorporating three-dimensional~     (3D)imaging during preoperative consultation on patient reported outcomes in primary breast~     augmentation surgery. 3D imaging is an innovative technology that allows the surgeon to share~     with images how one could look after one's procedure. The patient's assessment will be~     collected using the Breast Q, an objective questionnaire that captures patient satisfaction~     with breast augmentation.~   "
122321|NCT01966406|"~     Nasogastric decompression was routinely used in most major intra-abdominal operations.~     Nasogastric tube intubation was thought to decrease postoperative ileus (nausea, vomiting,~     and gastric distension). Wound and respiratory complications, and to reduce the incidence of~     anastomotic leaks after gastrointestinal surgery. However, the necessity of nasogastric~     decompression following elective abdominal surgery has been increasingly questioned over the~     last several years. Many clinical studies have suggested that this practice does not provide~     any benefit but could increase patient discomfort and respiratory complications. Furthermore,~     meta-analyses have concluded that routine nasogastric decompression is no longer warranted~     after elective abdominal surgery.~      Elective abdominal surgery without nasogastric decompression was initially tested and then~     widely used on patients with colorectal surgery. However, after upper gastrointestinal~     operations such as gastrectomy, nasogastric has been considered necessary to prevent the~     consequences of postoperative ileus (anastomotic leakage or leaking from the duodenal stump.~     Therefore, studies of gastrectomy without nasogastric tube emerged later than those of~     colectomy .~      In spite more and more studies reported of no need of nasogastric tube after abdominal~     operation, no papers reported after pancreaticoduodenectomy. Postulated causes of lack in~     studies to assess the need of a nasogastric tube after pancreaticoduodenectomy include~     anticipated prolonged postoperative paralytic ileus caused by PD-related extensive~     destruction and potential risk of gastric stasis after PD. However, our pilot study of~     retrospective analysis of postoperative NG drainage amount in 100 patients recently having PD~     at our hospital showed more than 90 % of patients had less than 200cc/day NG drainage amount~     in the first three days after operation. Theoretically, these patients will not need a~     nasogastric tube after pancreaticoduodenectomy. Therefore, we propose a prospective~     multicenter randomized trial to assess the need of a nasogastric tube after PD.~      Elective abdominal surgery without nasogastric decompression was initially tested and then~     widely used on patients with colorectal surgery.7-10 However, after upper gastrointestinal~     operations such as gastrectomy, nasogastric has been considered necessary to prevent the~     consequences of postoperative ileus (anastomotic leakage or leaking from the duodenal stump.~     Therefore, studies of gastrectomy without nasogastric tube emerged later than those of~     colectomy .11-13 In spite more and more studies reported of no need of nasogastric tube after~     abdominal operation, no papers reported after pancreaticoduodenectomy. Postulated causes of~     lack in studies to assess the need of a nasogastric tube after pancreaticoduodenectomy~     include anticipated prolonged postoperative paralytic ileus caused by PD-related extensive~     destruction and potential risk of gastric stasis after PD. However, our pilot study of~     retrospective analysis of postoperative NG drainage amount in 100 patients recently having PD~     at our hospital showed more than 90 % of patients had less than 200cc/day NG drainage amount~     in the first three days after operation. Theoretically, these patients will not need a~     nasogastric tube after pancreaticoduodenectomy. Therefore, we propose a prospective~     multicenter randomized trial to assess the need of a nasogastric tube after PD.~   "
122322|NCT01966393|"~     Closed-loop strategy is composed of three components: glucose sensor to read glucose levels,~     insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required~     insulin dosages based on the sensor's readings. A dual-hormone closed-loop strategy would~     regulate glucose levels through the infusion of two hormones: insulin and glucagon.~      The main objective of this project is to compare the efficacy of single-hormone closed-loop~     strategy, dual-hormone closed-loop strategy and conventional insulin pump therapy to regulate~     glucose levels in a 60-hours in non-standardized conditions in adults with type 1 diabetes.~      The investigators hypothesized that 1) Controlling glucose levels using single- or~     dual-hormone CLS is feasible in free-living conditions for long period of time (60 hours); 2)~     Dual-hormone CLS is superior to single-hormone CLS as assessed by reducing time spent in~     hypoglycemic range; 3) Both single-hormone and dual-hormone CLS are superior to conventional~     pump therapy.~   "
122323|NCT01966380|"~     The purpose of this reseach study is to determine Mölnlycke Health Care´s Leia dressing~     performance properties is fulfilled and that the dressing is safe when used on wound types~     such as pressure ulcer, leg ulcer, and diabetic foot ulcer.~   "
122324|NCT01966367|"~     This study's goal is to determine the frequency and severity of acute graft versus host~     disease, to evaluate incidence of primary and secondary graft rejection, to assess event free~     survival and overall survival, to determine the time to neutrophil and platelet engraftment,~     to determine the time to immune reconstitution (including normalization of T, B and natural~     killer (NK) cell repertoire and Immunoglobulin G production), and to establish the incidence~     of infectious complications including bacterial, viral, fungal and atypical mycobacterial and~     other infections following CD34+ selection in children, adolescents and young adults~     receiving an allogeneic peripheral blood stem cell transplant from a family member or~     unrelated adult donor for a non-malignant disease.~   "
122325|NCT01966354|"~     The purpose of this study is to assess the efficacy and safety of three ultrasound assistance~     techniques for internal jugular venous cannulation, in terms of cannulation success and~     prevention of complications.~   "
122326|NCT01966341|"~     This program has been created to help patients with irritable bowel syndrome manage their~     symptoms and increase their functioning by using cognitive therapy skills and hypnosis.~   "
122327|NCT01966328|"~     This research is studying the effect that Resolvine injection will have on patients with~     vitreomacular adhesion.~   "
122328|NCT01966315|"~     The investigators are going to compare the sleep quality and quantity between dexmedetomidine~     group and midazolam group using 24 hour polysomnography in critically ill patients. And the~     investigators also compare the incidence of delirium between the two groups.~   "
122329|NCT01966302|"~     The purpose of this study is to see if Lung LLC's new experimental formulation of the~     medicine Beraprost Sodium, called Beraprost Sodium 314d Modified Release (BPS-314d-MR), can~     improve the symptoms of pulmonary arterial hypertension (PAH) in patients. An experimental~     drug is one that has not been approved by the U.S. Food and Drug Administration for use in~     the general public. This research study is for patients who have pulmonary arterial~     hypertension (PAH) and have just completed taking part in an earlier research study and~     received an older experimental formulation of Beraprost Sodium, called Beraprost Sodium~     Modified Release (BPS-MR). That earlier study was being done to see if BPS-MR could improve~     their PAH.~      Patients may also be taking Tyvaso (treprostinil), Tracleer (bosentan), Letairis~     (ambrisentan), Adcirca (tadalafil) and/or Viagra or Revatio (sildenafil) to treat their PAH.~     The diagnosis of PAH means that the blood pressure in their lungs is higher than normal. The~     increased blood pressure in the lungs places a strain on the heart. The strain causes the~     heart to pump less blood into the lungs, causing shortness of breath and tiredness. The~     strain on the heart weakens the heart muscle making it less able to pump blood, a condition~     called heart failure. As heart failure develops, swelling in the feet and abdomen may occur.~   "
122330|NCT01966289|"~     This study will be looking at whether CY/GVAX in combination with SGI-110 is effective~     (recruits CD45RO+ T cells to the tumor which may be a marker of anti-tumor activity) and safe~     in patients with metastatic colon or rectum cancers.~   "
122331|NCT01966276|"~     The Synergy Trial will evaluate the safety and efficacy of a currently available medication~     (methylphenidate hydrochloride) combined with a CFS-specific dietary supplement (CFS Nutrient~     Formula) to treat Chronic Fatigue Syndrome (CFS).~   "
122332|NCT01966263|"~     The objective of this study is to determine whether either a femoral nerve block (FNB) or~     local infiltration analgesia (LIA) is a better anesthetic technique to achieve optimal~     functional outcome after one year in patients receiving a total knee arthroplasty and~     following a fast track rehabilitation protocol.~   "
122333|NCT01966250|"~     The purpose of this study is to find out the effectiveness of integrative medicine model for~     pain relief and improvement of function and quality of life on the patients with pain after~     back surgery.~   "
122497|NCT01964092|"~     Roughly one third of disability pensions issued in Norway are classified as mental and~     behavioral disorders. The proposed study aims to evaluate the effect of an innovative~     intervention for returning people with moderate to severe mental health disorders to work:~     Individual Placement and Support (IPS).~   "
122334|NCT01966237|"~     Acute kidney injury (AKI) occurs in 40% of children following heart surgery. Serum creatinine~     (Scr) is a late biomarker of AKI, rising 24-48 hours after surgery. Thus, for medicines~     excreted in the urine, AKI could potentially lead to toxic levels in the blood. Urinary~     biomarkers have the ability to detect AKI earlier. Whether early detection of AKI through~     urinary biomarkers can predict altered drug levels is unknown.~      Milrinone is used to improve heart function after surgery, but accumulates in AKI resulting~     in low blood pressure. Dose adjustments are not currently possible because of the late rise~     in SCr, and are based on clinical parameters that may lead to clinically relevant over or~     under-dosing. Thus, this study will address an important knowledge gap being the first to use~     elevations of AKI biomarker concentrations to anticipate increased milrinone levels.~   "
122335|NCT01966224|"~     This is a continuing research study of a vaccine for allergy to Japanese Red Cedar. The~     vaccine is called CryJ2-DNA-LAMP Plasmid vaccine. This research study will determine how the~     vaccine is tolerated and how previous Phase IA research participants respond to the vaccine~     in a booster dose. CryJ2-DNA-LAMP Plasmid vaccine is investigational, which means it is not~     approved for use by the United States Food and Drug Administration (FDA) but is available in~     research studies like this one. The study is a Phase IB, prospective, three cohort, open~     label study conducted on one cohorts of non-atopic subjects and two cohorts of subjects with~     a history of allergic rhinitis symptoms to Japanese red cedar CryJ 2 pollen allergen that~     participated in the previous Phase IA study (all the subjects participated in the previous~     study). The study will be conducted at 1 study center. Subjects are enrolled in the trial for~     a period of 80 days. The objectives of the statistical analyses are to establish the safety~     and to explore the immunogenicity of the LAMP-vax vaccine. All statistical analyses conducted~     on the data from this trial will be exploratory in nature.~      The primary objective of this Phase IB Study is to evaluate the safety and immunological~     responses of an additional dose of CryJ2-DNA-LAMP plasmid vaccine delivered intramuscularly~     (IM) to subjects who previously received 4 doses of CryJ2-DNA-LAMP vaccine delivered IM every~     2 weeks in the previous Phase IA study.~   "
122336|NCT01966198|"~     Novel pulse plethysmography-derived indexes has been proposed as a tool to measure autonomic~     nervous system modulation in anaesthetized and awake patients, but nowadays a physiologic~     validation is lacking. We aim to examine the effects of sympathetic stimulation on pulse~     plethysmographic amplitude (PPGA), autonomic nervous system state (ANSS) and autonomic~     nervous system state index (ANSSi).~   "
122337|NCT01966185|"~     The purpose of this study is to establish learning curves of mastoidectomy training in~     virtual surgical simulation training, to establish the long-term effect of repeat simulation~     training and to explore the transfer of skills, the roles of an integrated tutor function,~     self-directed learning and cognitive load.~   "
122338|NCT01966172|"~     To test if multimodal analgesia with different analgesic medication offer better pain relief,~     lesser side effects and is safe compared to conventionel opiod analgesia after cardiac~     surgery.~   "
122339|NCT01966159|"~     The purpose of this study is to assess the safety and effectiveness of the SYNERGY™ Coronary~     Stent System for the treatment of subjects with atherosclerotic lesion(s) ≤ 34 mm in length~     (by visual estimate) in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by visual~     estimate)~   "
122340|NCT01966146|"~     Aim of the study is the definition of criteria for a standardized assessment of heart~     function by 3D echocardiographic procedures. Standardized criteria will be defined to assess~     aortic valve insufficiency after TAVI and success of mitral valve replacement respectively.~   "
122341|NCT01966133|"~     Investigators hypothesise that the use of transarterial chemoembolisation (TACE) after liver~     resection in patients with hepatocellular carcinoma can eradicate residual cancer cells in~     the liver and thus improve survival of patients with high risk factors for residual tumor.~     The aim of this study is to compare the survival of patients with high risk factors for~     residual tumor undergoing liver resection plus post-operative TACE versus liver resection~     alone.~   "
122342|NCT01966120|"~     The purpose of this study is to evaluate the safety and efficacy of BF-200 ALA (Ameluz)~     versus placebo in the field-directed treatment of mild to moderate actinic keratosis with~     photodynamic therapy (PDT) when using the BF-RhodoLED lamp.~   "
122343|NCT01966107|"~     The Objectives of this study are to assess the safety of Aclidinium bromide on major adverse~     cardiovascular events (MACE), to assess the overall safety of Aclidinium bromide and to~     assess whether Aclidinium bromide reduces moderate or severe COPD exacerbations. This study~     is a double-blind, randomized, placebo controlled, parallel-group study to evaluate the~     effect of Aclidinium bromide on the cardiovascular safety and COPD exacerbations in patients~     with moderate to very severe COPD, as defined by the Global Initiative for Chronic~     Obstructive Lung Disease (GOLD) criteria.~   "
122344|NCT01966094|"~     It is estimated that over 1 million people in the United States have HIV infection. While HIV~     is treatable, there are still high rates of HIV-associated neurocognitive disorder (HAND).~     HAND is defined by low scores on memory testing. To meet the criteria for HAND, an~     HIV-infected individual has to have a low score on at least two different memory tests. It is~     estimated that 20-50% of people living with HIV have HAND. It is therefore still a common~     problem. While individuals with HAND typically improve on antiretroviral therapy for HIV,~     often this improvement is incomplete. Also, there are over 20 antiretroviral medications~     approved for HIV in the US. It is not clear if the specific choice of antiretroviral~     medication makes a difference in the improvement of HAND.~      The investigators have designed a small preliminary study in which subjects with and without~     HAND who have never been on treatment for HIV or have been off treatment for at least 6~     months are followed for the first 12 months after starting antiretroviral therapy.The~     investigators will enroll a maximum of 46 subjects (23 subjects in each arm). Subjects will~     also be followed by their primary HIV medical provider. For the study, subjects will be~     followed for 48 weeks. There are three followup visits: 12 weeks, 24 weeks, and 48 weeks.~     Memory testing will be performed at baseline and each followup visit. Blood will also be~     taken at baseline and the three followup visits to measure changes in inflammation. A lumbar~     puncture will be performed at baseline and at 24 weeks to measure changes in inflammation and~     amount of HIV virus in the spinal fluid. There is also an optional lumbar puncture at the~     last study visit of 48 weeks~   "
122346|NCT01966068|"~     This study will enroll parents/guardians of children who receive treatment at one of the~     pediatric primary care practice settings in the Pediatric Research in Office Settings (PROS)~     network or at the Children's Hospital of Philadelphia's Pediatric Research Consortium (PeRC)~     network.~      The study will use an evidence-based conceptual model to study determinants of implementation~     success, implementation outcomes, and health care outcomes resulting from implementing an~     already functional, electronic health record (EHR)-linked asthma portal, MyAsthma. The study~     will measure the portal's feasibility and determine the impact on providing asthma education~     and fostering patient engagement as well as the ability to collect patient-reported outcomes~     for children, evaluate medication use and side effects and track parents' preferences and~     goals.~   "
122347|NCT01966055|"~     A study of the safety and pharmacokinetics of solithromycin capsules in adolescents~   "
122348|NCT01966042|"~     Therapeutic neovascularization is an innovative strategy for cardiac tissue recovery due to~     chronic, intense ischemia. Thus stem cell therapy has become a promising procedure for the~     large number of patients with refractory angina due to coronary disease, despite of the use~     of multiple anti-angina medications, remain severely symptomatic with disabling angina.~      Stem cell therapy using autologous cells from the patient's bone marrow, has been shown to be~     safe and associated with improved myocardial perfusion, reducing the symptoms of advanced~     coronary artery disease and increasing the functional capacity of patients whose therapeutic~     armamentarium available today has been exhausted.~      The study hypothesis was that the infusion of autologous mononuclear cells derived from the~     patient's bone marrow and delivered via intramyocardial injection in patients with refractory~     angina and normal or slightly depressed ventricular function, promote improvement in the~     anginal symptoms and myocardial perfusion by the inducing neoangiogenesis.~   "
122349|NCT01966029|"~     There is currently no treatment for MPS IVA other than supportive care for the clinical~     manifestations of the disease. Enzyme replacement therapy (ERT) with BMN 110 to replace the~     deficient GALNS is a potential new treatment option for MPS IVA patients. BMN 110, containing~     recombinant human GALNS (rhGALNS) developed by BioMarin is expected to reduce the~     progressive, pathologic accumulation of KS, and improve signs and symptoms of the disease.~      The objective of this Phase 3B open label study (110-502) will be to evaluate the safety and~     tolerability of 2.0 mg/kg/week (qw) of BMN 110 in Australian patients with MPS IVA. In~     addition, a number of secondary and tertiary efficacy endpoints will also be investigated.~     The dose and regimen of BMN 110 have been selected on the basis of data from a Phase 1/2~     clinical study with BMN 110, nonclinical and in vitro studies with BMN 110, and clinical and~     nonclinical data from other enzyme replacement therapies.~      Extension Phase is included per amendment dated 10Mar 2014: To provide patients enrolled in~     the Initial Phase access to BMN 110 until commercial product becomes available in Australia~     and continue to assess long-term safety~   "
122350|NCT01966016|"~     Cardiac resynchronization therapy (CRT) is a proven therapy in patients with severe left~     ventricular (LV) dysfunction with ejection fraction (EF)<35%., moderate to severe congestive~     heart failure and wide QRS in ECG. Positive response presents as improvement in quality of~     life, decrease in congestive hrat failure symptoms and signs, improvements in~     echocardiographic measurements and longer survival. About 30% of the patients do not respond~     to this treatment.~      A decrease in clinical response to CRT is expected in patients with those predictors:~     advanced age, male, ischemic etiology of cardiomyopathy, Non-LBBB pattern in ECG, lack of~     mechanical dyssynchrony, large scar in LV, congestive heart failure stage IV, and non-cardiac~     co-morbidities (lung disease, pulmonary hypertension, renal failure and diabetes).~      There are few solutions to increase the rate of clinical response to CRT, for example:~     endocardial pacing of LV or pacing a few simultaneous sites on LV. A study that investigated~     a method of simultaneous pacing on LV of patients with congestive heart failure and LBBB with~     QRS>150ms has shown major improvement of cardiac contraction (increased dP/dtmax) compared to~     a single pacing site over a postero-basal or lateral wall site).~      Implantation of pacemaker leads- one in right ventricle (RV) and two over LV, i.e. multisite~     cardiac resynchronization therapy (MSCRT), has a few potential advantages, compared to~     conventional CRT.~   "
122351|NCT01966003|"~     The purpose of this research study is to compare the effectiveness and safety of ABP 215~     against bevacizumab in men and women with advanced non-small cell lung cancer.~   "
122352|NCT01965990|"~     Body weight excess, from overweight to overt obesity, is associated with adverse health~     outcomes. In view of the time-trends of the obesity epidemic and the related cost burden, the~     search for effective strategies for weight reduction and long-term maintenance of weight loss~     (WL) is at the top of the agenda of public health systems.~      The current first-line strategy includes several treatment options and dietary interventions~     to be implemented together with an exercise program. Unfortunately, compliance with~     intervention in the long-term is difficult. It is not infrequent to observe people following~     one diet after another and experiencing multiple failures which, in turn, lead to higher body~     weight and adverse consequences on body composition and fat distribution. The higher the~     number of attempts, the more difficult the adherence to further interventions. In the~     presence of severe (body mass index >40 kg/m2) or complicated obesity, bariatric surgery~     could be proposed. This therapeutic option is effective, but is not devoid of complications~     and may be irreversible. Obesity-related complications, such as diabetes, hypertension or~     sleep apnoea are likely to occur more frequently with increasing body mass index (BMI) and~     rapid and considerable WL is mandatory to curtail such risks.~      In this scenario, alternative treatment options are warranted. About 40 years ago, after the~     introduction of protein-sparing modified fasting (PSMF) achieved through the use of oral~     high-protein foods or liquid formula diets by Blackburn and Bistrian, several studies~     evaluated its effectiveness and safety. They showed that responsible and supervised very-low~     calorie diets (VLCDs) could be considered safe and appropriate therapy for obesity.~      The purpose of the present study was to investigate the potential role of a 2-week course of~     enteral treatment with a very low-calorie protein-based formula in the management of severe~     obesity.~      The rationale of this treatment option rests on the following considerations: 1) VLCDs appear~     to be able to reduce cardiovascular risk rapidly and effectively; 2) VLCDs induce~     considerable short and long-term WL; 3) optimal compliance with the intervention, as active~     participation of the patient is not required; 4) continuous administration of the~     intervention formula by enteral route enables the the maintenance of the body amino acid~     pool.~      Before being proposed for clinical use, a new WL program should be scientifically evaluated.~     Accordingly, in the present study, attention was focused not only on efficacy in terms of~     improving the cardiometabolic risk profile, but also on the feasibility and safety of the~     procedure.~   "
122353|NCT01965977|"~     This study is an Open-labeled, multicenter Phase II study of Bortezomib for maintenance~     therapy in patients with high risk diffuse large B cell lymphoma (DLBCL). Primary objective~     is 3 years relapse free survival (RFS) and Secondary objectives are 3 years overall survival~     (OS), 3 years event free survival (EFS),Toxicities profiles, Quality of Life (FACT&GOG-Ntx)~   "
122823|NCT01959828|"~     Sixteen Japanese subjects (6 adults/10 children) with peri- and post-operative pulmonary~     hypertension associated with cardiac surgery will be evaluated at approx. 6 sites for safety~     and efficacy of IK-3001.~   "
122355|NCT01965951|"~     Problems with attention are a common and debilitating consequence of brain injury. Studies~     show that poor attention is the number one predictor of poor cognitive functioning one year~     post-injury. This is due to the fact that attention is a necessary component of more complex~     cognitive functions such as learning & memory, multi-tasking and problem solving. In many~     cases, individuals may exhibit problems with spatial attention known as 'hemi-spatial neglect~     syndrome' or simply 'neglect'. Many studies now show that the processing machinery of the~     brain is plastic and remodeled throughout life by learning and experience, enabling the~     strengthening of cognitive skills or abilities. Research has shown that brief, daily~     computerized cognitive training that is sufficiently challenging, goal-directed and adaptive~     enables intact brain structures to restore balance in attention and compensate for~     disruptions in cognitive functioning. The study aims to understand how our computer program~     can affect cognition and attention in those with acquired brain injury.~   "
122356|NCT01965938|"~     We will conduct a randomized trial comparing the success rate and time to intubation using~     the RIFL vs. the fiberoptic bronchoscope, as the latter is commonly held to be the gold~     standard of difficult airway devices. Specifically, we wish to compare the of intubation~     between the two devices in patients with potentially difficult airways as defined by an~     oropharyngeal class 3-4, BMI greater than 35, or in patients with a history of difficult~     intubation using direct laryngoscopy.~   "
122357|NCT01965925|"~     This is an 8-week, randomized, placebo-controlled trial of modafinil in stable bipolar~     disorder patients. Results will provide information on a promising treatment for~     simultaneously treating both sleep and cognitive problems in stable bipolar patients. These~     disabling symptoms persist despite stable mood and are strongly associated with functional~     disability, making them important treatment targets that have not yet been adequately~     addressed.~   "
122358|NCT01965912|"~     The study is a single-cohort, interventional, open-label trial to evaluate long-term~     neurocognitive (NC) outcomes in children aged 4 to 5 years with phenylketonuria (PKU) treated~     with Kuvan® and Phenylalanine-restricted diet over a period of 7 years.~   "
122359|NCT01965899|"~     The purpose of the Reveal LINQ Usability Study is to assess the functionality of the Reveal~     LINQ insertable cardiac monitor and accompanying system in patients indicated for an~     insertable cardiac monitor~   "
122360|NCT01965886|"~     The most common surgical approach to perform a total knee replacement is called medial~     parapatellar approach. It's effective and can be applied virtually to all types of knee~     deformities. The Keblish approach is an alternative approach which uses the lateral side of~     the patella to enter the joint. Some orthopaedic surgeons consider the latter approach a~     better option when facing a valgus deformity of the osteoarthritic knee but there is no~     convincing evidence on the literature supporting one or another approach. The objective of~     this study is to compare the medial vs lateral approach for total knee replacement on valgus~     knee.~   "
122361|NCT01965873|"~     The purpose of this prospective randomised clinical trial is to compare beneficial and~     harmful effects of the use enteral nutrition versus a nil-by-mouth and intravenous fluid~     replacement principle of treatment in patients with moderate to severe acute pancreatitis~     (AP).~      The hypothesis:~        -  enteral nutrition is no significantly better compared with the nil-by-mouth principle~          regarding mortality, incidence of local and systemic complications, length of hospital~          stay, and intensity of the inflammatory response in patients with moderate to severe AP~        -  enteral nutrition has the same safety as nil-by-mouth principle in patients with~          moderate to severe AP~   "
122362|NCT01965860|"~     The main goal is to design a comprehensive endovascular simulation curriculum consisting of~     cognitive and psychomotor skills training for endovascular management of symptomatic vascular~     disease in the lower limbs (Rutherford classification 2-5; stenosis or occlusion in the~     iliac, superficial femoral and popliteal arteries). The curriculum will consist of~     E-learning, video-based learning and simulation exercises on the Virtual Reality simulator on~     which an endovascular procedure will be simulated.~      Skills transferability to real life practice will be verified by means of a RCT. In this RCT~     the investigators will compare the cognitive knowledge and technical performance of~     curricular trained surgical trainees with conventionally trained trainees during treatment of~     patients under supervision. The hypothesis states that surgeons trained within the PROSPECT~     curriculum will show improved technical knowledge of endovascular treatment of~     atherosclerotic disease in the iliac, superficial femoral and popliteal arteries and will~     demonstrate increased technical proficiency in the angiosuite in comparison with surgeons who~     received only conventional training. Subjects will be surgical trainees (N=60). They will be~     randomized into a control group (N=30) and a PROSPECT group (N=30). Both groups will continue~     their traditional clinical education and the PROSPECT group will additionally be trained~     within this endovascular curriculum. The investigators hope that this study may ultimately~     lead to an improvement in the quality of patient care by standardizing competencies of~     endovascular operators in training and practice.~      Additionally a cost-effectiveness analysis of PROSPECT compared to traditional training~     modalities will be executed. A successful training program is expected to lead to a~     shortening of the learning curve, reduction in number of errors during real life procedures~     and more efficient use of hybrid angio suites. The financial impact of potentially shorter~     duration of endovascular interventions will be studied and compared to time investment and~     additional costs associated with stepwise, supervised training using VR simulators.~   "
122363|NCT01965847|"~     Hypertension is a major risk factor for cardiovascular and renal disease, and a leading cause~     of premature mortality worldwide. Ambulatory blood pressure (BP) monitoring (ABPM) allows for~     assessment of BP throughout the day and night. Of all the BP measurements, nighttime systolic~     BP appears to be the best predictor of cardiovascular disease and all-cause mortality.~     Importantly, elevated nighttime BP is a modifiable risk factor; evening dosing of~     antihypertensive medications lower nighttime BP and reduces proteinuria. In a large,~     randomized controlled trial, evening dosing of antihypertensive medications reduced the~     hazard rate for major cardiovascular events by 67%. Findings were similar in the subgroup of~     participants with chronic kidney disease (CKD). However, this single-center study was~     designed to evaluate cardiovascular outcomes, not progression of CKD. The long-term effect of~     nighttime dosing of antihypertensive medications on progression of CKD is unknown.~      To address this important gap in knowledge, the investigators plan to conduct a pragmatic,~     randomized controlled trial. 3600 participants at risk for progression of CKD who are taking~     ≥1 antihypertensive medication once daily will be randomized to morning versus evening dosing~     of at least one antihypertensive medication. The purpose of the current study is to obtain~     pilot data demonstrating the feasibility of the trial and the efficacy of the intervention.~   "
122739|NCT01960920|"~     Exposure to air pollution is associated with increase in cardiovascular morbidity and~     mortality. Controlled human exposure studies have demonstrated impaired vascular function and~     heart rate variability on healthy volunteers. The aim of this study is to investigate the~     effects of reducting diesel exhaust inhalation on endothelial function, heart rate~     variability and cardiopulmonary stress testing in healthy volunteers and patients with~     chronic heart failure, by using a filter mask.~   "
122364|NCT01965834|"~     Multiple myeloma cells are dependent on calcium (Ca2+) for their function. Specifically, Ca2+~     is required for the function of the endoplasmic reticulum in which proteins, including~     immunoglobulins, are folded prior to their release from the cell. Multiple myeloma cells~     secrete large concentrations of immunoglobulins continuously and as result depend on~     mitochondria activity to replenish the Ca2+ levels in the endoplasmic reticulum as was shown~     in vitro in our lab. Fenofibrate has been shown to inhibit mitochondrial function resulting~     in inhibition of protein folding in the endoplasmic reticulum of multiple myeloma (MM) cells~     that leads to the induction of a stress signal known as the unfolded protein response and~     subsequently apoptosis. The effective anti-myeloma concentrations for fenofibrate are~     attainable in the clinical setting as they are in the same range as the effective~     concentrations for anti-hyperlipidemic effect. The investigators propose to evaluate~     fenofibrate therapy in multiple myeloma patients.~   "
122365|NCT01965821|"~     Despite intermittent control of tracheal cuff pressure using a manual manometer, cuff~     underinflations and overinflations frequently occur in critically ill patients, resulting in~     increased risk for microaspiration and tracheal ischemic lesions. The aim of this study is to~     determine the efficiency of Mallinckrodt electronic device (Mallinckrodt electronic cuff~     pressure controller, VBM Medizintechnik GmbH, Sulz aN) in continuous control of tracheal cuff~     pressure.~   "
122366|NCT01965808|"~     Participants in this study will receive two oral doses of 150 milligram (mg) LY2157299 taken~     at least 4 days apart. One dose will be given without food. One dose will be given with a~     high fat meal. The study will evaluate the effect of a high fat meal on how much of the drug~     gets into the blood stream. Side effects will be documented. This study will last~     approximately 15 days not including screening. Screening is required within 30 days prior to~     the start of the study.~   "
122367|NCT01965795|"~     The purpose of this pilot study is to evaluate the potential effects of whole coffee fruit~     concentrate (WCFC, Neurofactor), a product that elevates circulating brain-derived~     neurotrophic factor (BDNF), on cognition and mood in healthy adults.~      The projected outcome of this study is that self-administration of Neurofactor for 28 days~     (or even 14 days) will be associated with an improvement in mood and scores on cognitive~     tests, and that the change will exceed that observed with administration of Nutrim (placebo).~      Volunteers will be recruited from the greater Los Angeles community. Participants will be~     middle-aged nonsmokers, in good health, and between the ages of 40-55 to enhance the chance~     of demonstrating pro-cognitive effects. Younger participants, whose cognitive performance is~     expected to be higher, may perform at a ceiling level, with less room for improvement by the~     product under study.~      Participants who call our lab will be told about the study in more detail, and will complete~     a 5 minute phone screener to determine preliminary eligibility. After the initial telephone~     screening, participants will visit Dr. London's laboratory at UCLA to provide written~     informed consent.~      The first study visit will be an in-person screening visit to determine full eligibility. The~     evaluation will include a psychiatric diagnostic interview, using the SCID, blood tests,~     urine samples (to test for drug use and pregnancy). Participants will also be interviewed~     about their prior and current drug use, including tobacco use. In addition, participants will~     be interviewed about the nature of their employment and physical exercise habits: endurance~     training has been shown to increase plasma BDNF in young men.~      Participants meeting the inclusion criteria will attend the Semel Institute for Neuroscience~     and Human Behavior at UCLA to take part in baseline measurements, and to be randomized to~     receive either WCFC or placebo. During the active treatment time (28 days), they will visit~     the UCLA Semel Institute on a weekly basis. At each of these weekly visits, questionnaires~     regarding compliance will be completed, and blood samples will be taken for assay of BDNF. A~     cognitive test battery and mood-rating scales will be completed at baseline and at 14 and 28~     days of treatment. At the midpoint assessment (14 days) and at completion of treatment (28~     days) blood will be drawn for assay of a blood chemistry panel (as at baseline) as well as~     for biomarkers in addition to BDNF.~   "
122368|NCT01965782|"~     This type of study is called a radiolabeled study. For this study, LY23023703 (study drug)~     has been specially prepared to contain radiolabeled carbon [14C]. [14C] is a naturally~     occurring radioactive form of the element carbon. This study will help understand how the~     drug appears in the blood, urine, and stool after it is administered to healthy men.~     Information about any side effects that may occur will also be collected. This study will~     last up to 15 days for each participant, not including screening. Screening is required~     within 28 days prior to the start of the study.~   "
122369|NCT01965769|"~     Omitting evaluation of gastric residual contents prior to feeding very premature infants will~     increase the feeding intake at 2 weeks, and total caloric intake and growth by 3 weeks, as~     well as decrease the time required for parenteral nutrition.~   "
122370|NCT01965756|"~     Alzheimer's disease (AD) is a neurodegenerative disorder characterized by progressive loss of~     memory and other cognitive functions. It is the most common cause of dementia in older~     adults, affecting approximately 18 million people worldwide, including almost 500,000 in the~     Philadelphia tri-state area. After age 65, the incidence of AD rises exponentially, doubling~     every five years. By age 85, almost half of us will have AD. In 2030, as many as 7.7 million~     Americans could have AD, and by 2050 this number could rise to 11-16 million people. The~     annual cost of AD in the United States is about $200 billion. AD-related medical~     complications are among the most common causes of death in the elderly population. Despite~     these alarming statistics, a cure for AD may not be essential since delaying the onset of~     AD by just 5 years could have a profound impact on this disorder by reducing the incidence~     and cost of AD by 50% between now and 2050.~      AD is difficult to recognize in its earliest stages, in which the principal complaint is~     typically an increase in episodes of forgetfulness. This stage is now commonly referred to as~     mild cognitive impairment (MCI). Neuroimaging and CSF biomarkers have demonstrated good~     accuracy in predicting which MCI patients later convert to AD and which tend to remain~     stable or revert to more normal cognition. The diagnosis of AD itself is made when increased~     loss of memory and other cognitive abilities (eg, language, praxis, and executive function)~     affect daily functioning. As the symptoms of dementia inevitably worsen, patients may become~     incapable of even basic activities such as feeding and dressing themselves. The disease~     course often spans more than a decade, creating a vast social and financial burden on society~     and extracting an immeasurable emotional toll on family members.~      Clinical and preclinical evidence is accumulating that brain insulin resistance may play a~     role in the pathogenesis and/or progression of Alzheimer's disease and that ameliorating~     insulin action in the brain may benefit cognition symptomatically and modify disease~     pathology.~   "
122371|NCT01965743|"~     This study has two goals: 1) to test an approach to helping women who use intrauterine~     contraception (IUC) spread the word about this type of long-lasting, highly effective birth~     control method among their friends and family and; 2) to test ways of getting in touch with~     these women's friends and family so that we can track whether this approach is effective at~     spreading birth control information through social groups.~   "
122372|NCT01965730|"~     This study hopes to determine the optimal antifibrinolytic dosing to decrease bleeding and~     blood transfusion after cardiac surgery without increasing adverse events~   "
122373|NCT01965717|"~     Endovascular procedures already brought enormous revolution in the process of treatment of~     patient with abdominal aortic aneurysm (AAA). It is well defined that early mortality and~     morbidity is significantly reduced comparing to open repair. The persistent concern is long~     term durability of devices and their success of aneurysm exclusion in order to prevent~     rupture. At the moment the best armament to prevent rupture after endovascular exclusion is~     the watchful waiting and timely reintervention. The main complication that follows this~     procedure and causing catastrophic long term complications is endoleak. The ideal algorithm~     to follow up patients after aneurysm exclusion has not been found. In order to reveal~     endoleak ultrasound is used more than before, however frequent computerized tomography is~     wasting a lot of costs and exposing patients to irradiation and nephrotoxic contrast.~      Matrix metalloproteinase activity has been demonstrated in the process of aneurysm~     development. Imbalance between MMP and its inhibitors TIMP provokes collagenolytic and~     elastolytic activity that is inducing aneurysmatic degeneration of aortic wall. Due to the~     previously described connection between aneurysm and MMP activity, it was proved that serum~     level of MMP-9 is significantly higher in patients with abdominal aortic aneurysm (AAA).~     Also, higher levels of MMP-9 were discovered in patients with inadequate aneurysm exclusion~     after endovascular procedure suggesting that degradation of the aortic wall is still ongoing~     process, not being the case with successfully excluded aneurysm. There might be a potential~     role of MMP-9 serum level as a biomarker of present endoleak after endovascular aneurysm~     exclusion.~      All published trials have shown correlation between MMP 9 activity and presence of endoleak,~     however, no correlation was made between specific types of endoleak and necessity to~     reoperation (clinical significance). Additionally there were only four trials presented in~     the literature investigating low number of patients.~      Since there is possible value of MMP-9 serum level as biomarker of present endoleak, further~     studies are necessary. This why we are organizing multicentre trial, that will cover~     significant number of patients in order to define~        -  Value of MMP-9 as a biomarker of successful initial exclusion~        -  Value of MMP-9 level as predictor of aneurysm shrinkage~        -  Value of MMP-9 level in patients with increased aneurysm diameter and no visible~          endoleak~        -  Correlation of the MMP -9 serum level with different type of enoleak~        -  Value of MMP-9 as biomarker of successful treatment of endoelak~      Material and methods Patient with AAA greater then 55 mm in diameter that are candidates for~     endovascular repair will be selected. Demographic, anatomical and data regarding the~     procedure will be gathered prospectively. Also serum levels of MMP-9 will be measured before~     procedure, during the first week before discharge, and after 1,6,12,18,24,36,48 months. On~     the same day of measuring MMP-9 level control MSCT and ultrasonography exam will be performed~     in order to collect data regarding the success of exclusion and presence of any endoleak with~     the accurate measurement of aneurysm diameter changes. Ultrasonography and MSCT exam will be~     performed by experienced physicians, also preoperative evaluation of anatomical data.~      In case of reintervention additional questionnaire will be filled regarding anatomical and~     procedure related data using pre and postoperative ultrasound and MSCT examination, while~     MMP-9 levels will be measured before procedure and after the procedure using the same~     protocol as for primary procedure.~      Statistical analysys Levels of MMP-9 in serum with presence of different types of endoleak~     will be correlated one week and 1,6,12,18,24,36 48 months after the procedure Anatomical data~     will be correlated with the decrease in MMP-9 level before and after procedure Levels of~     MMP-9 in serum after one week and one month will be correlated with further aneurysm~     shrinkage Level of MMP-9 in serum with type of endoleak will be correlated Level of MMP-9~     before and after reoperation will be compared Level of MMp-9 in serum of patients with~     disappearing endoleaks will be followed Level of MMP-9 in serum of patients with new~     endoleaks will be followed~   "
122763|NCT01960608|"~     Increasing sodium intake raises blood pressure. And high salt intake could hinder the~     management of chronic disease. Much previous research has confirmed that dietary habits are~     affected by economic status. So we compared sodium intake with economic status. We~     investigated the prevalence, extent and management, and the relevance of sodium intake with~     income level.~   "
122374|NCT01965704|"~     The Investigators hope to learn if they can prevent or lessen the symptoms of neonatal~     abstinence syndrome (NAS) in babies born to narcotic-dependent mothers by using the drug~     ondansetron in the mothers prior to delivery and their babies after delivery.~      The study is a randomized, double-blind, placebo-controlled study with one half the~     mother-baby pairs to receive ondansetron and the other half of the mother-baby pairs to~     receive placebo. The pregnant narcotic-dependent mothers will receive an intravenous dose of~     study medication prior to delivery; the neonates, after their birth, will receive the same~     study medication the mother received every 24 hours for up to 5 days.~      The Investigators will follow up with the mother-baby pairs for 10 days after study drug has~     stopped and one last follow up, about 30 days after stopping study drug, to learn if the baby~     had any symptoms of NAS in that time period.~   "
122375|NCT01965691|"~     Phenylketonuria (PKU) is an inherited inborn error of an amino acid phenylalanine (PHE)~     metabolism affecting 1:15,000 births. It is caused by a decreased activity of an enzyme in~     the liver called phenylalanine hydroxylase (PAH) which is important to convert PHE into~     tyrosine, another amino acid. Consequently, PHE accumulates in the blood leading to mental~     and developmental delays. Nutritional management is the primary choice of treatment that~     includes providing sufficient protein in the diet and at the same time restricting PHE.~     However the amount of protein to be given is unknown. A new technique called Indicator Amino~     Acid Oxidation (IAAO) will be used to determine the protein requirements in children with PKU~     (5-18y). The study will help treat and manage these children with sufficient protein to~     ensure proper growth and development. Current dietary recommendations range from 35-65 g/day~     and is based on factorial calculations.~      The investigators hypothesize that the protein requirement in children with PKU will be~     higher than the current mathematically calculated recommended intake of 35-65 g/day for the~     5-18y children.~   "
122376|NCT01965678|"~     Aim of this study is to evaluate the effectiveness of osteopathy in changing quality of life~     in a large sample of naive patients undergoing osteopathic manipulative treatment.~   "
122377|NCT01965665|"~     The purpose of this study is to prospectively evaluate the effect of Active Leptospermum~     honey utilizing the MediHoney HCS dressing, on the occurrence of PIN site infections, and~     also to see if the use of MediHoney HCS reduces the frequency of dressing changes compared to~     published reports of routine standard pin site care.~   "
122378|NCT01965652|"~     The purpose of this study is to evaluate the long-term safety of naldemedine for the~     treatment of constipation due to opioid therapy.~   "
122379|NCT01965639|"~     The purpose of the Southeastern Diabetes Initiative Clinical Intervention is to augment~     existing standard of care in an effort to (1) improve population level diabetes management,~     health outcomes and quality of life for diagnosed and undiagnosed adults living with Type 2~     Diabetes Mellitus, (2) reduce disparities in diabetes management, health outcomes and quality~     of life for adults living with Type 2 Diabetes Mellitus, and (3) reduce healthcare costs~     associated with Type 2 Diabetes Mellitus.~   "
122380|NCT01965626|"~     Oseltamivirphosphate is hydrolysed to its active metabolite-the free carboxylate of~     oseltamivir. Oseltamivir is a neuraminidase inhibitor, serving as a competitive inhibitor of~     the activity of the viral neuraminidase (NA) enzyme upon sialic acid, found on glycoproteins~     on the surface of platelets. By blocking the activity of the enzyme, oseltamivir may prevent~     platelet destruction in liver.The project was undertaking by Qilu Hospital of Shandong~     University and other 5 well-known hospitals in China. In order to report the efficacy and~     safety of oseltamivirphosphate combined with high-dose dexamethasone for the treatment of~     immune thrombocytopenia (ITP) with high platelet desialylation level, compared to high-dose~     dexamethasone therapy.~   "
122381|NCT01965613|"~     The purpose of this study is to determine if treatment with Xionix will improve wound healing~     for patients with pyoderma gangrenosum.~   "
122382|NCT01965600|"~     An endotoxin challenge will be administered to healthy subjects to induce production of~     inflammatory markers. An investigational drug or placebo will be administered prior to the~     endotoxin challenge to assess the effect of the investigational drug on the markers of~     inflammation. Safety and tolerability will also be assessed.~   "
122383|NCT01965587|"~     Hypothesis. Combined treatment with novasure and mirena IUS confers benefit over Novasure~     alone in the treatment of menorrhagia~   "
122384|NCT01965574|"~     Preload dependence assessment is difficult during prone position, and to date, no hemodynamic~     parameters have been validated to rationalize fluid loading in that position. This study aims~     to validate several hemodynamic parameters, using continuous cardiac output by pulse contour~     analysis and transpulmonary thermodilution.~   "
122385|NCT01965561|"~     Normal human adult volunteers wereused to investigate the performance of medical devices~     intended to stop junctional bleeding on the battlefield.~   "
122386|NCT01965548|"~     In blunt trauma, the spleen is most frequent injured organ in the abdomen and the most~     frequent source of bleeding in the abdomen.~      Historically, splenectomy was the treatment of choice for splenic bleeding. For~     exsanguinating patients, open splenectomy is still the proper choice of treatment if the~     spleen is a significant source of bleeding. However, for hemodynamic stable patients with~     splenic injury, non-operative management (NOM) is an alternative, assuming they have no other~     indication for surgery (peritonitis).~      Non-operative management includes observation and/or splenic artery embolisation (SAE), but~     the indications for observation and SAE varies between trauma centers. The greatest advantage~     of NOM is the preservation of splenic function.~      In the investigators hospital splenic artery embolisation was introduced in 2007. The~     investigators want to describe the treatment of splenic injuries in their hospital, to see if~     the number of splenectomies has been recduced after 2007, and to see if SAE has also been~     used in transferred trauma patients.~   "
122404|NCT01965314|"~     Investigators hypothesize that virtual reality based training offers an additional learning~     benefit over standard training (using cadaveric dissection and human volunteers) in preparing~     novice anaesthetists to perform their first Ultrasound guided Axillary Brachial Plexus~     Blockade (USgABPB) in the clinical setting.~      Investigators hope that this body of work will aid the development of a visuo-haptic~     simulator used to improved training of doctors in performing USgABPB. Ultimately any patient~     having this procedure carried out in the future should benefit. In particular it will avoid~     the need for novice trainees to practice new techniques on patients.~   "
122405|NCT01965301|"~     Phase I Single Ascending Dose (Part 1), phase IIa Proof Of Concept (Part 2)~   "
122387|NCT01965535|"~     This study is to determine the antiviral efficacy of sofosbuvir (SOF)/ledipasvir (LDV)~     fixed-dose combination (FDC) with and without ribavirin (RBV), and to evaluate the safety and~     tolerability of each regimen as assessed by review of the accumulated safety data.~     Approximately 150 participants with genotype 1 HCV infection, who have previously received~     treatment for HCV, and who have a diagnosis for cirrhosis will be enrolled. Participants will~     be randomized to 1 of 2 groups.~      Group 1: SOF/LDV FDC tablet plus placebo to match RBV for 24 weeks~      Group 2: Delayed treatment group: placebo to match SOF/LDV FDC plus placebo to match RBV for~     12 weeks, followed by SOF/LDV FDC once daily plus RBV in a divided daily dose for 12 weeks~      Randomization will 1:1 to the two groups and will be stratified by HCV genotype (1a, 1b;~     mixed or other genotype 1 results will be stratified as genotype 1a), and prior HCV therapy~     treatment response (never achieved HCV RNA < the lower limit of quantitation (LLOQ), or~     achieved HCV RNA < LLOQ).~   "
122388|NCT01965522|"~     Investigators plan to carry out a study to investigate two different pills, Vitamin D and~     melatonin, and whether they can reduce the spread of cancer cells in the tumors of women with~     breast cancer. These pills are inexpensive and have very few side effects. A large number of~     studies using cell cultures and animals have shown that both vitamin D and melatonin can help~     destroy breast cancer cells. However thoughtful and well-designed studies are necessary on~     humans to see if they can decrease the spread of breast cancer, and possibly even prevent~     breast cancer. The proposed study aims to understand the anti-cancer activity of vitamin D~     and melatonin. This knowledge will assist in creating efficient cancer prevention strategies~     for Canadians. This study will include women with breast cancer who are being planned for~     surgery, and will assess whether treatment with vitamin D (dose of 2000 IU per day) in a~     group of 36 women, or melatonin (dose of 20mg per day) in another group of 36 women, or both~     pills together in yet another group of 36 women, reduces the spread of cancer cells when~     compared to a fourth group of 36 women who are treated with sugar pills. To do this we will~     measure a substance in the blood called Ki67, which provides information about the spread of~     cancer. Investigators will compare the Ki67 levels in the 4 groups, and all women will~     receive identical appearing pills so they will not know which treatment they received.~   "
122389|NCT01965509|"~     Polyethylene Glycol Loxenatide (PEX168) is a new human glucagon-like peptide 1 (GLP-1)~     analogue that created on the basis of the Exenatide and modified by polyethylene glycol~     (PEG).~      This study aims to evaluate the effective therapeutic concentration range of PEX168, also~     decided to observe safety and PK/PD correlation by long-term continuous administration.~   "
122390|NCT01965496|"~     Polyethylene Glycol Loxenatide (PEX168) is a new human glucagon-like peptide 1 (GLP-1)~     analogue that created on the basis of the Exenatide and modified by polyethylene glycol~     (PEG).~      This study aims to evaluate whether the titration mode of administration could reduce the~     incidence of adverse reactions of PEX168, also decided to observe long-term continuous~     administration of PK/PD correlation.~   "
122391|NCT01965483|"~     The implementation of a weekly hypofractionated radiation could be an advantageous~     alternative. The convenience of less treatment days could cause a greater adherence, decrease~     of costs and increase the offer of radiotherapy to major number of patients in underserved~     areas.~      The purpose of this study is to determine in women with diagnosis of initial breast cancer~     undergoing breast-conserving surgery the effects of the adjuvant radiotherapy using a once a~     week regimen, with 5 fractions in total. The study will analyze the acute toxicity of~     radiation, the patient's self referred quality of life, the cosmetic breast appearance, as~     well the oncological safety. It will also be analyzed the viability of this more contracted~     regimen in our community setting, regarding the patient's adherence to the treatment.~   "
122392|NCT01965470|"~     The BCPP study is designed to test the hypothesis that implementing an enhanced combination~     prevention package which includes provision of ART to all participants, regardless of CD4~     count or HIV disease severity, will impact the HIV/AIDS epidemic by significantly reducing~     population-level, cumulative HIV incidence in a defined geographic area over a period of 3~     years and will be cost-effective.~   "
122393|NCT01965457|"~     The term adenoids describes lymphoid tissue on the superior and posterior walls of the~     nasopharynx, and their hypertrophy is a common condition of childhood. When enlarged,~     adenoids can obstruct the nasopharyngeal airway and cause mouth-breathing, hyponasal voice,~     and snoring. In more severe cases, obstructive sleep apnea (OSA) may result, which carries~     potential risk of neurocognitive disturbance, growth failure, and heart-lungs disease.~     Adenoid hypertrophy can also be associated with otitis media with effusion, possibly through~     Eustachian tube dysfunction or chronic adenoidal infection.~      Methods for identification of adenoid hypertrophy include the clinical history, examination,~     imaging (eg, plain lateral x-ray), or by nasal endoscopy witch enable direct visualization of~     the nasal cavity with dynamic evaluation of any nasal airway obstruction.~      Objectives :~      The aim of this study is to prospectively examine invasive and non-invasive office procedures~     to assess adenoids hypertrophy, including clinical history, x-ray imaging, and nasal~     endoscopy.~      Methods :~      Prospective, observational study in pediatric patients aged 2-18 that will be referred to the~     otolaryngology pediatric 'Clalit' clinic in Haifa after x-ray imaging and an informed~     consent.~        1. Nasal Obstruction Index (NOI) The NOI questionnaire for history and physical exam will~          be evaluated at the clinic, as described by Paradise grading system.~        2. Plain lateral x-rays Plain lateral X-rays of the patients will be evaluated only if the~          patients had them at the time of referral. Adenoidal obstruction will be assessed by~          Fujioka's Adenoid-Nasopharynx ratio.~        3. Fiberoptic nasal endoscopy (FNE) Fiberoptic analysis will be done as an office procedure~          using a 2.4mm Storz nasal flexible endoscope following an application of Lidocaine gel~          locally into the nostril and on the endoscope distal end. Adenoidal obstruction will be~          assessed by Parikh grading system.~   "
122394|NCT01965444|"~     The objective of this study is to establish required data for SEM Scanner analysis of the~     readings given by the SEM Scanner in the target patient population.. In order to better~     understand the data this non-invasive scanner provides a collection of data/readings is~     required to be collected in a certain population. This will help with clinical interpretation~     of the numbers and readings this device will provide.~   "
122395|NCT01965431|"~     The objective of this study is to evaluate the effect of multiple doses of BI 207127 combined~     with faldaprevir on cardiac safety parameters in healthy subjects~   "
122406|NCT01965288|"~     The aim of this study is to compare the clinical performance of the Biofinity Toric~     (comfilcon A) contact lens, versus Air Optix for Astigmatism (lotrafilcon B) over 1 month of~     daily wear.~   "
122407|NCT01965275|"~     the purpose of this study is to evaluate the efficacy and safety of high-dose，pulsatile~     Erlotinib/Gefitinib in advanced non small cell lung cancer (NSCLC) patients after failure of~     standard dose EGFR-TKIs（Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors）~   "
122408|NCT01965262|"~     This purpose of this study is to compare the clinical performance and subjective acceptance~     of two different daily disposable limbal ring lenses.~   "
122396|NCT01965418|"~     This research puts liver biopsy as the enrollment screening criteria and the primary efficacy~     assessment indicators. Patients at different developmental stages of hepatitis B related~     liver fibrosis are respectively diagnosed and treated by Traditional Chinese medicine to~     determine optional diagnosis and treatment plan of traditional Chinese medicine to screen the~     advantage-treated population and to establish a treatment program, which can save national~     medical resources, for clinical application of Traditional Chinese medicine Diagnosis and~     Treatment blocking and reversing hepatitis B-related liver fibrosis. The research can help to~     build automation pathological analysis and diagnosis systems and non-invasive clinical~     assessment criteria and models of liver fibrosis which can be applied in clinical. It can~     also help to realize electronic patient data collection and management, to establish patients~     management centre and follow-up database. Then it will help to improve clinical efficacy of~     being blocked and reversed chronic hepatitis B related liver fibrosis by Chinese medicine~     Diagnosis and Treatment program, to reduce the incidence of liver cirrhosis and hepatitis~     B-related mortality, to prolong patients' survival and improve patients' quality of life, to~     make clinical efficacy, which is about Traditional Chinese Medicine blocking and revering~     chronic hepatitis B-related liver fibrosis, increase by 15% or more .~   "
122397|NCT01965405|"~     In this proposed study with People Living with HIV/AIDS (PLWHA), we will use a stepped care~     model called a Sequential Multiple Assignment Randomized Trial (SMART) to examine the~     efficacy of low- and high-intensity smoking cessation treatments for nicotine dependent PLWHA~     that incorporate the current standard of care and prize-based contingency management.~     Intervention will be administered in a community-based HIV integrated care clinic in downtown~     Detroit, which has the highest prevalence rates of HIV/AIDS and smoking in Michigan. Phase 1~     will last 4 weeks, and will involve brief intervention to help participants stop smoking. For~     phase 2, participants will be assigned to different study arms depending on whether they are~     Responders (reduced their smoking) or Non-responders (continued to smoke).~        1. Phase 1: We hypothesize that brief high-magnitude prize contingency management will~          result in greater reduction in smoking than standard of care alone.~        2. Phase 2a: We hypothesize that non-responders who are assigned to contingency management~          will be more likely to reduce their smoking throughout treatment and to abstain from~          smoking at all follow-up points.~        3. Phase 2b: We hypothesize that responders who are assigned to monitoring and~          low-magnitude prize contingency management will be more likely to maintain their reduced~          or abstinent smoking status at all follow-up time-points.~   "
122398|NCT01965392|"~     The aim was to assess whether nursing interventions based on Health Educational Programs for~     primary informal caregivers of dependent patients may improve their quality of life,~     decreasing emotional burden and increasing caregiving knowledge, in order to better meet~     patients' basic needs.~   "
122399|NCT01965379|"~     Hyperphosphatemia is related to the increase in morbidity and mortality. There is greater~     risk for cardiovascular disease, atherosclerotic disease, secondary hyperparathyroidism, and~     bone disease .~      The serum phosphorus level can be controlled by a combination of factors, such as: reduction~     of ingestion, reduction of intestinal absorption with chelating agents and increase in~     elimination by dialysis.~      The purpose of this study is to evaluate the effect of dietary intervention consisting of the~     restriction of industrialized foods with phosphorus additives in chronic kidney disease~     patients treated with hemodialysis.~   "
122400|NCT01965366|"~     Evidence from preliminary studies suggests that people with PTSD have heightened fear~     responses and that cortisol suppression reduces this heightened fear. Research has shown the~     drug dexamethasone (DEX), a cortisol suppressor, reduces the startle response in civilians~     with PTSD. This current research proposal represents a blinded, randomized,~     placebo-controlled efficacy study with the goal of determining whether a drug that suppresses~     the stress hormone cortisol will increase the efficacy of exposure therapy. Specifically, it~     is proposed that a dose of DEX, given the night before (approximately 10 hours before) each~     of 5 to 11 individual virtual reality exposure (VRE) therapy sessions, will significantly~     enhance the rate of response and possibly the efficacy of treatment. Participants will be~     treated until they have experienced at least a 70% reduction in PTSD symptoms from baseline~     or up to 12 sessions or until they and their therapist agree treatment should be terminated,~     a minimum of 6 sessions to a maximum of 12 sessions. Comprehensive multi-modal outcomes will~     be assessed by independent assessors blind to subject condition on interviews, self-report~     measures, and psychophysiological measures. Participants will be assessed pre- and~     post-treatment and at a follow-up of 3, 6 and 12 months to assess long term effects.~   "
122401|NCT01965353|"~     This research study is evaluating an investigational drug called panobinostat (LBH589) in~     combination with the standard agents lenalidomide, bortezomib, and dexamethasone as a~     possible treatment for multiple myeloma.~   "
122402|NCT01965340|"~     Sepsis is the major cause of morbidity and mortality amongst burn patients. Burn shock and~     respiratory failure that used to be the major cause of mortality have progressively been~     replaced by sepsis and multiple organ failure. It is not rare that treatment failures occurs~     several weeks, or even months after injury as a consequence of sepsis usually caused by~     multi-drug resistant (MDR) microorganisms. Introduction of early surgery combined with~     topical and systemic antibiotherapy dramatically enhanced survival from sepsis after burn~     trauma, but further improvement is impaired by the rapid development of hard-to-treat MDR~     bacteria.~      Correct prescription of anti-infective agents could be one way to curb the steadily~     increasing development of multidrug resistance. Administration of antibiotic to burn patient~     is complex: they frequently suffer from kidney dysfunction, they usually experience~     tremendous shifts of liquids between intra-vascular - inter-cellular and intra-cellular~     compartments, they often are hypo-albumin and protein-emic, and finally they present with a~     profoundly modified metabolism. All those aspects make this particular population of patients~     at high risk of both under or over prescription.~      Monitoring of drug concentrations in the plasma of patients, so-called TDM for Therapeutic~     Drug Monitoring, has been introduced to clinical practice for several decades primarily to~     avoid toxicity of a small number of drugs with narrow therapeutic windows. However, with the~     increasing availability of detection techniques, the number of drugs that can be measured in~     the plasma of patients has grown tremendously over the last decade. As a consequence, it is~     currently possible to monitor drug concentrations not only to prevent toxicity, but also to~     improve efficacy. For instance, several studies demonstrated that TDM improved antibiotic~     prescription in different populations of hospitalized patients, including critically ill~     patients, with a direct impact on outcome.~      Such studies amongst burn patients are however lacking, although this particular population~     is at high risk to suffer from mis-prescription. We thus hypothesize that systematic TDM~     could improve antibiotic prescription in this peculiar population. To this end, we propose to~     implement a 3-year prospective, randomized, mono-centric, clinical trial that will analyze~     the impact of systematic TDM on anti-infective agent prescription amongst burned patients.~   "
122421|NCT01965080|"~     A phase II study of Exemestane in Advanced or recurrent endometrial carcinoma~      Hypothesis: Treatment With Exemestane can give a response rate of at least 30%~   "
122409|NCT01965249|"~     The major long term complication of abdominal wall closure after a median laparotomy is the~     development of an incisional hernia. Several suture technique and suture material have been~     used but the incidence of this complication still lies between 9 -20%. Synthetic suture~     material which have become available over the last decades have the advantage that they are~     degraded by the body system and fully absorbed within 70-180 days; however they loss 50% of~     their initial strength already after 14-30 days and may not be the optimal suture material~     for abdominal wall closure. A new suture material (Monomax®) was developed with an extra-long~     absorption profile, high elasticity and with a superior initial strength. Therefore, the~     ESTOIH-Study was designed to investigate the influence of the stitch length on the occurrence~     of incisional hernia using the extra-long term absorbable, elastic, monofilament suture~     (Monomax®).~   "
122410|NCT01965236|"~     The objective of the present study is to asses the effectiveness of the aorta-ventricular~     coupling according to low and high sodium intake in 28 controled hypertensive patients.~   "
122411|NCT01965223|"~     The main purpose of this study is to determine the safety (defined as number of participants~     experiencing ≥ 5% toxicity at 12 months post treatment) of stereotactic ablative fractionated~     radiotherapy versus radiosurgery for oligometastatic neoplasia to the lung.~   "
122412|NCT01965210|"~     Acute effects on appetite and metabolic function have been observed for whole-grain rye~     cereal products. The aim of this study is to evaluate if the appetite suppressing effect of a~     whole-grain rye breakfast cereal may be further enhanced by the addition of fermentable~     dietary fibre and plant protein. The aim is also to try to elucidate how observed effects on~     subjective appetite are mediated in terms of changes in hormonal signals, flow of nutrients~     in the blood and products from bacterial fermentation of dietary fibre, and to relate this to~     the different composition of the breakfasts.~   "
122413|NCT01965184|"~     This is a randomized controlled study of cognitive-behavioral therapy (CBT) for disruptive~     behavior such as anger and aggression in children and adolescents. CBT will be compared to~     Supportive Psychotherapy (SPT) and participants of this study will be randomly assigned (like~     the flip of a coin) to receive CBT or SPT. Participants will be also asked to complete~     functional magnetic resonance imaging (fMRI) and electrophysiological (EEG) tasks~     (recordings/images of brain activity) before and after treatment. CBT is a behavioral~     intervention that consists of 12 one-hour long, weekly sessions. During CBT children are~     taught various skills for coping with frustration and parents are taught various strategies~     for managing situations that can be anger provoking for their child. This study is conducted~     to examine whether reduction of behavioral problems including anger outbursts, irritability,~     aggression and noncompliance after CBT may be paralleled by changes in areas of the brain~     responsible for emotion regulation and social perception.~   "
122414|NCT01965171|"~     Red cell transfusions are an important part of supportive cancer therapy. The iron in the~     transfused blood may build up in the body since the human body has no way to get rid of extra~     iron. Iron tends to build up in the liver and the heart muscle. It is unknown if iron~     build-up is present many years after completing cancer therapy. It is also not known if extra~     iron causes harm to internal organs. Researchers at St. Jude Children's Research Hospital~     (SJCRH) want to understand if iron build-up (called iron overload) exists in survivors of~     leukemia. They also want to know if iron overload can cause injury to your organs if it is~     present.~      Liver iron accumulation has been documented in childhood cancer survivors, however, it is not~     known if iron associated organ toxicity is contributing to the long-term morbidity that has~     been well documented among these survivors. This study will investigate the prevalence of~     iron overload and the association of tissue iron burden with markers of organ dysfunction in~     leukemia survivors. This study will determine the prevalence of iron overload among long-term~     leukemia survivors that underwent blood transfusion. This study will use blood and magnetic~     resonance imaging (MRI) testing to determine iron overload of specified organs. Understanding~     the prevalence of iron overload could impact surveillance practices in leukemia survivors.~      PRIMARY OBJECTIVE:~        -  To determine the prevalence of iron overload in the liver [liver iron concentration~          (LIC) >3mg/g using R2* MRI measurements] and in the heart (T2* <20 ms) among long-term~          leukemia survivors transfused with ≥50ml/kg of packed red blood cells.~      SECONDARY OBJECTIVES:~        -  To examine the relationship between hepatic, cardiac, and endocrine dysfunction and~          transfusionally acquired iron overload as defined by R2* and T2* MRI among survivors of~          pediatric leukemias.~        -  To investigate the association between serum ferritin, transferrin saturation,~          non-transferrin-bound iron, and hepcidin measurements with R2* and T2* MRI-defined iron~          overload.~   "
122415|NCT01965158|"~     The purpose of this study is to evaluate the efficacy and safety of naldemedine in the~     treatment of opioid-induced constipation (OIC) in adults with non-malignant chronic pain who~     are not using laxatives.~   "
122416|NCT01965145|"~     The objective of this study is to demonstrate the superiority of gevokizumab as compared to~     placebo on top of current standard of care in reducing the risk of Behçet's disease uveitis~     exacerbations~   "
122417|NCT01965132|"~     We plan to establish a nationwide Biologics Registry (in the form of an inception cohort) to~     study the safety profiles in rheumatoid arthritis, ankylosing spondylitis and psoriatic~     arthritis patients receiving biologic agents.As this registry is to observe the real world~     use of anti-rheumatic treatments under routine clinical practice, no hypothesis to prove is~     planned.~   "
122418|NCT01965119|"~     The purpose of this study is that ruxolitinib may be a possible treatment option for relapsed~     or refractory patients with Hodgkin and primary mediastinal large B-cell lymphoma.~   "
122419|NCT01965106|"~     This study will assess any side effects that may occur when QPI-1007 is injected into the eye~     in subjects with acute primary angle-closure glaucoma, as well as how long it takes for the~     body to clear the drug. This study will also test whether QPI-1007, injected into the eye,~     helps prevent both structural damage of the nerve tissue in the eye and the loss of visual~     function in subjects with acute primary angle-closure glaucoma.~   "
122420|NCT01965093|"~     The most serious peri-operative respiratory event (PRE) in pediatric anesthesia is~     desaturation or hypoxemia which could lead to cardiovascular collapse or cardiac arrest.~     Intermittent hypoxic episode especially in infants are also associated with impaired growth,~     longer-term cardiorespiratory instability and poor neurodevelopmental outcome.12 The~     mechanism of peri-operative desaturation occurring in normoxia infant brain is quite similar~     to overabundance of oxygen in the acutely hypoxic infant by using 100% oxygen or hyperoxia~     for resuscitation of acutely asphyxiated infants which can generate excessive neurotoxic~     compounds and increase oxidative stress markers.17 Anesthetic agents which involve~     gamma-aminobutyric acid (GABA)receptors eg; volatile agents, midazolam and~     N-methyl-D-aspartate receptor (NMDA) receptors eg; nitrous oxide, ketamine can cause neuronal~     apoptosis, neuronal necrosis, neuronal cell death and memory deficit in rat pups. Moreover,~     prolonged anesthetic exposure, irrespective of open heart surgery, can influence~     neurodevelopment of the brain in rodents.17 However, the evidence for anesthetic agents~     causing apoptosis and neurodegeneration in human neonatal brain is still not clear.~      Thus, peri-operative desaturation occurred in young age regardless of severity combined with~     general anesthesia might possibly affect the long-term impact regarding growth and~     neurodevelopmental outcome in infant or intelligence outcome in older children. In our study,~     we are interested in looking at the intelligence outcome, which is a part of neurodevelopment~     outcome, in preschool children aged ≤ 5 years who developed desaturation peri-operatively.~     Because we include a wide range of age between newborn to five years old to test~     neurodevelopment outcome in older children, the intelligence outcome may be more appropriate~     and can be applied to infants and younger ages. Therefore, the objective of study was to~     compare intelligence outcome between children who developed peri-operative desaturation and~     children who did not develop PRE.~   "
122422|NCT01965067|"~     The primary efficacy endpoint is the time from the start of administration of sugammadex to~     recovery of the TOF ratio to 0.9 in deep neuromuscular block (1-2 twitches post-tetanic~     count) induced by rocuronium during mild hypothermia with core temperatures between 34.5°C~     and 35°C, and compared with the normal thermal condition.~      Secondary endpoints include time from the start of administration of sugammadex to recovery~     of the TOF ratio to 0.7 or 0.8 in both groups, vital signs [heart rate and blood pressure] at~     pre-reversal, post-reversal, recovery and post-anesthetic visit, the incidence of residual~     neuromuscular blockade, post-operative nausea and vomiting (PONV) and adverse events during~     mild hypothermia and the normal thermal condition.~      We hypothesize that mild hypothermia with core temperatures between 34.5°C and 35°C diminish~     the efficacy of sugammadex.~   "
122423|NCT01965054|"~     Intrahepatic cholestasis of pregnancy (ICP) is a unique disease of the liver resulting in~     abnormal bile acid levels and liver function. The incidence of ICP ranges from 0.1 - 15.6%.~     Women diagnosed with ICP most often present with itching, which may be severe. More~     concerning, however, is the impact of ICP on adverse fetal and pregnancy outcomes, including~     preterm delivery, meconium exposure, fetal demise, and increased neonatal respiratory~     complications. The risk for fetal demise has been estimated to be 1-3%. The mechanism of~     fetal demise in ICP is unknown, and therefore cannot be reliably predicted. There is evidence~     to suggest that extremely elevated bile acids levels are associated with worse fetal~     outcomes, particularly levels greater than 40 μmol/L.~      Ursodeoxycholic acid (UDCA) has anticholestatic effects, and is used to treat a variety of~     cholestatic liver diseases. Many studies have demonstrated superiority of UDCA over other~     agents, including dexamethasone and cholestyramine, for relief of maternal pruritus,~     improvement in transaminitis, reduction in serum bile acid concentrations, and improved~     pregnancy outcomes. As a result, UDCA is now widely used as first-line treatment for~     symptomatic relief in patients with ICP.~      Docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) are two omega-3 long chain~     polyunsaturated fatty acids found in fish. DHA is known to play a key role in early fetal~     brain development, and has been associated with modest beneficial effects on~     neurodevelopmental and cognitive outcomes in children. In neonates with parental~     nutrition-induced cholestasis (PN-cholestasis), parental fish oil has been shown to be~     hepatoprotective not only for treatment of PN-cholestasis, but for prevention of cholestasis~     in premature infants at risk for the disease. Our hypothesis is that fish oil supplementation~     with DHA in women with ICP who are treated with UDCA will increase the rate of decline in~     serum total bile acid levels.~      The incidence of ICP at a single hospital center in Queens, NY is estimated to be 5%~     secondary to a high concentration of patients from high-risk ethnic groups. High risk~     patients with bile acid levels greater than or equal to 40 μmol/L are managed aggressively~     with inpatient admission for continuous fetal monitoring, treatment with UDCA, and serial~     total bile acid levels weekly. These are patients are routinely offered early delivery after~     documented fetal lung maturity between 36 and 37 weeks gestation, or for any signs of fetal~     distress. This study is a prospective randomized controlled trial comparing weekly serum~     total bile acid levels in women admitted for inpatient management of ICP among women~     supplemented with a standard prenatal vitamin versus supplementation with a prenatal vitamin~     and DHA.~   "
122424|NCT01965041|"~     Adult-onset vitelliform detachments associated with pattern dystrophy is a genetic disorder~     that carries visual implications that most commonly affect the macula (area in the eye near~     the retina that is essential for sharp central vision). Adult onset vitelliform detachments~     have an accumulation of material on the outer retina. Over time, the abnormal accumulation of~     this material can damage cells that are critical for clear central vision. As a result,~     people with this disorder often lose their central vision, and their eyesight may become~     blurry or distorted.~   "
122425|NCT01965028|"~     Stimulation of the left and right auditory cortex with daily transcranial random noise~     stimulation (tRNS) is used to modulate the neural pathways involved in chronic tinnitus.~   "
122426|NCT01965015|"~     The V-Wave atrial-septal shunt implant is intended for the reduction of elevated left atrial~     filling pressures ('Left Atrial Decompression') in chronic, New York Heart Association (NYHA)~     class III -IV, Heart Failure (HF) patients. This is a First In Man (FIM) study, aimed to~     enable a first evaluation of the safety and performance of the V-Wave shunt implant when~     implanted in Chronic Heart Failure patients. Prospective, open label, single-arm study with~     intra-patient comparisons (i.e. subjects' status will be compared to their pre-implant~     (baseline) status.~   "
122427|NCT01965002|"~     The goal of this project is to evaluate the safety and preliminary efficacy of ExAblate~     magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) surgery in the~     treatment of soft tissue tumors of the extremities.~   "
122428|NCT01964989|"~     Safety, Immunogenicity and Efficacy of an Adjuvanted Quadrivalent Subunit Influenza Virus~     Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children ≥6 to <72 Months~     of Age.~   "
122429|NCT01964976|"~     To examine the safety and efficacy of long-term combination therapy with alogliptin (Nesina)~     and biguanides in participants with type 2 diabetes mellitus who responded inadequately to~     treatment with biguanides in addition to diet therapy and exercise therapy.~   "
122430|NCT01964963|"~     The purpose of this study is to examine the safety and efficacy of long-term treatment with~     alogliptin (Nesina) in patients with mild type 2 diabetes mellitus in the routine clinical~     setting.~   "
122431|NCT01964950|"~     The purpose of this study is to examine the safety and efficacy of long-term combination~     therapy with alogliptin (Nesina) and sulfonylurea in participants with type 2 diabetes~     mellitus who responded inadequately to treatment with sulfonylurea in addition to diet~     therapy and exercise therapy.~   "
122432|NCT01964937|"~     This study will evaluate the safety and immune response to five different combinations of~     three HIV vaccines in healthy, HIV-uninfected adults.~   "
122433|NCT01964924|"~     This phase II trial studies how well trametinib and v-akt murine thymoma viral oncogene~     homolog 1 (Akt) inhibitor GSK2141795 work in treating patients with triple-negative breast~     cancer (breast cancer cells that do not have estrogen receptors, progesterone receptors, or~     large amounts of human epidermal growth factor receptor 2 [HER2/neu] protein) that has spread~     to other places in the body. Trametinib and Akt inhibitor GSK2141795 may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth.~   "
122443|NCT01964794|"~     Clinically relevant biomarkers for warfarin identified in this study will provide crucial~     leads for subsequent studies to assess their predictive value during anticoagulant therapy.~     This knowledge will aid stratifying risk among patients to improve therapeutic outcomes and~     decrease adverse drug events and associated health care costs. Collectively, these efforts~     will provide a critical foundation for future research using a metabolite biomarker strategy~     in a clinical setting to revolutionize warfarin therapy. Through its application, a real−time~     assessment of warfarin metabolism for each patient could lead to a truly personalized dosing~     strategy and improve patient safety for this life−saving drug.~   "
122764|NCT01960595|"~     The purpose of this study is to investigate the efficacy and cost analysis of intravenous~     fentanyl combined with either local anesthesia infiltration or peroneal nerves block in~     patients with Hallux Valgus undergoing orthopedic corrective surgery and compared with~     patients without local anesthetics administration perioperatively.~   "
122434|NCT01964911|"~     Hypertensive leg ulcer, also called Martorell ulcer, represents 1 to 15% of leg ulcers in~     hospital. These ulcers are painful, long to heal, and hospitalization is sometimes necessary~     for analgesia and debridement of necrotic tissue. Strong opioids are often required, and are~     responsible of many side effects. Martorell ulcer arises predominantly in women over 60 years~     of age, with history of vascular disease, and therefore with a higher risk of adverse event.~     Pain is also part of the physiopathology, inducing a vasospasm which increases ulcer~     extension and ischemia.~      This is why pain management is one of the main challenge in treatments of these ulcers.~      Continuous nerve block of lower limbs are often used during per and postoperative orthopaedic~     surgery. Few adverse events and rare serious adverse events related to local anesthesic are~     reported (respectively <1% and <1/1000), and few adverse events related to catheter are~     reported (<1%). Its benefits have been proved on post-operative pain management and~     reeducation.~      The aim of this study is to assess analgesia provided by continuous sciatic nerve block, in~     patients with hypertensive leg ulcer, during hospitalization.~      Thirty patients will be enrolled on a 3-years period. They will receive a continuous sciatic~     nerve block with ropivacaïne 0,2%, during 7 days.~      Pain intensity will be assessed by 4 datas : numerating rating scale (NRS) at rest, during~     wound care, maximal and mean. These datas will be collected over two 3-days period : the~     first 3 days of hospitalization, in which pain treatment will be prescribed depending on pain~     intensity of the patient ; and the first 3 days of ropivacaïne treatment.~      The main evaluation criteria will be at least a 50% decrease of one of the pain NRS when~     receiving ropivacaïne.~      Time to healing, microcirculation evolution measured by Transcutaneous Oxygen Pressure~     (TcPO2), and quality of life of patients will be collected over a 6 months follow-up.~   "
122435|NCT01964898|"~     Smoking and depressed mood are both predictive of mortality following Acute Coronary~     Syndrome. However, to date, no counseling treatment has been designed to target smoking~     cessation and manage mood in this population. This trial will test such a treatment based on~     Behavioral Activation, an approach that has shown promise as an integrated treatment for~     smoking and mood management in other populations.~   "
122436|NCT01964885|"~     IQP-AS-105, is a food supplement derived from garlic (Allium sativum). The objective of this~     study is to evaluate the possibilities of clinical use of IQP-AS-105 as a preventive~     medicine, based on its ability to enhance the immune system responses~   "
122437|NCT01964872|"~     The purpose of the study is to assess the safety, tolerability, pharmacokinetics, and~     pharmacodynamic effects of single oral doses and multiple oral doses of JNJ-38877618~     administered for 7 consecutive days in healthy adult male participants.~   "
122438|NCT01964859|"~     This research is being done to determine if investigators can change skin from one type to~     another. Specifically, investigators are interested in making normal skin into the thicker~     skin found on our palms and soles.~   "
122439|NCT01964846|"~     The general objective of this project is to investigate the acute effect of consuming a~     dietary supplement combining resveratrol and curcumin on the inflammatory response following~     the consumption of a high-fat meal in healthy subjects with slightly elevated waist~     circumference.~      The study will be undertaken according to a double-blind, cross over, randomized, placebo~     controlled design and will be conducted at the Institute of Nutrition and Functional Foods~     (INAF) of Laval University. The study will involve a total of 20 healthy subjects (10 men and~     10 women. Included subjects will undergo an 6-hour oral fat tolerance, on two separate~     occasions (one time following dietary supplement consumption and one time following~     consumption of a placebo). The two test days will be separated by maximum of two weeks. The~     outcomes are the changes in the plasma levels of inflammatory cytokines in their gene~     expression.~   "
122440|NCT01964833|"~     The relationship between diabetes mellitus (DM) and periodontal disease is bidirectional. DM~     is a predisposing and modifying factor of periodontitis, which, in turn, worsens glycemic~     control and increases proteins found in the acute phase of inflammation. The gold standard~     for the treatment of periodontal disease is oral hygiene orientation, scaling and planing.~     Moreover, systemic antibiotic therapy may be employed in some cases. In an effort to minimize~     the prescription of antibiotics, photodynamic therapy (PDT) has been studied as an~     antimicrobial technique and has demonstrated promising results. The aim of the proposed study~     is to determine whether PDT as a complement to periodontal therapy (PT) is helpful in the~     metabolic control of individuals with type 2 diabetes and the reduction of acute phase~     inflammatory markers. The patients will be randomized using a proper software program into~     two groups: 1) PT + placebo PDT or 2) PT + active PDT. All patients will first be examined by~     a specialist, followed by PT performed by two other healthcare professionals. At the end of~     each session, PDT (active or sham) will be administered by a fourth healthcare professional.~     The following will be the PDT parameters: diode laser (660 nm); power output = 110 mW;~     exposure time = 90 seconds per point (9 J/point); and energy density = 22 J/cm2. The~     photosensitizer will be methylene blue (50 µg/mL). The patients will be re-evaluated 15, 30,~     90 and 180 days after treatment. Serological exams with complete blood count, fasting~     glucose, glycated hemoglobin and crevicular fluid exams to screen for tumor necrosis factor~     alpha, interleukin 1, interleukin 6, osteocalcin, osteoprotegerin/RANKL will be performed at~     each evaluation. At baseline and 180 day periapical radiographs will be performed to evaluate~     the alveolar bone crest level. The data will be statistically evaluated using the most~     appropriate tests.~   "
122441|NCT01964820|"~     Major depressive disorder affects over 120 million people worldwide. Only 50% of Americans~     with depression receive adequate treatment, and one-third of those receiving treatment do not~     benefit. In this pilot project investigators will bring together two approaches that have the~     promise to reach large numbers of depression sufferers: a skills-based intervention for~     increasing positive affect and experiences in depressed individuals, delivered in an~     inexpensive self-paced mobile format. The study will make use of smartphone technology to~     improve conventional outcome measurement via in-the-moment emotion sampling and mobile~     assessment of heart rate variability, a predictor of cardiac health that may mediate some of~     the health effects of depression. The aims are: 1) Retool the existing web-based positive~     emotion intervention for use on smartphones, with innovative exercises that help participants~     bring the skills they are learning into real- life situations; 2) Measure heart rate~     variability and emotions using existing smartphone software; and 3) Perform a randomized~     pilot trial of the mobile intervention on individuals with clinical depression recruited~     online.~   "
122442|NCT01964807|"~     The overarching goal of this project is to develop a panel of cardiovascular risk biomarkers~     that can detect differences in the cardiovascular safety of various tobacco products, whether~     conventional, new or emerging, in order to help the FDA with the task of regulating them.~     This will be achieved through 4 aims:~      Aim 1: Determine the relative contributions of nicotine and combustion products to the~     cardiovascular risk of active cigarette smoking.~      Aim 2: Determine which cardiovascular risk biomarkers are affected by exposure to secondhand~     smoke.~      Aim 3: Determine the cardiovascular risk of smokeless tobacco use. Aim 4: Determine the~     cardiovascular risk of electronic cigarettes and the respective contributions of nicotine and~     electronic cigarette vapor.~   "
122851|NCT01959464|"~     The purpose of this study is to determine if sexual intercourse lowers serum progesterone in~     women using vaginal progesterone gel (Crinone®), and increases serum progesterone in their~     male sexual partners. We hypothesize, based on previous estrogen studies done by our group,~     that intercourse will interfere with absorption of vaginal progesterone.~   "
122444|NCT01964781|"~     After surgical procedures, interventions to reduce postoperative pain and bleeding are of~     great importance. In this study, the effect will be investigated of smearing common drugs,~     which are designed for injection, directly onto the raw wound surface (topical application)~     created during surgery. Topical application allows a small amount of drug to reach a large~     wound area, higher drug concentration in the exposed wound surface but very low concentration~     in the body, and no risk of injury from needles. Although beneficial effects of such an easy~     and low-cost intervention would be expected, the investigators have found no previous reports~     on blinded and controlled studies.~   "
122445|NCT01964768|"~     A Phase III study to determine the sensitivity and specificity of three solutions of~     different allergen extracts for diagnosis by skin prick-test:~        -  5 Grasses pollen,~        -  Birch pollen,~        -  Dermatophagoides pteronyssinus mite~   "
122446|NCT01964755|"~     By combining a variety of agents that potentiate Zidovudine (ZDV), the investigators hope to~     induce remission in this generally fatal disease. Most therapies for aggressive B cell~     lymphomas are based upon intensive chemotherapeutic regimens, expensive modalities (bone~     marrow transplant, Rituximab), or experimental approaches (gene therapy, cytotoxic T cell~     infusion) that are difficult to implement in heavily pre-treated patients. Therapy for~     relapsed aggressive B cell lymphomas is very poor. Even curable lymphomas such as Burkitt~     Lymphoma (BL) and Hodgkin lymphoma are extremely difficult to treat in relapse and/or after~     stem cell transplant failure. The investigators propose a novel therapeutic approach that~     exploits the presence of Epstein-Barr virus (EBV) in lymphomas; antiviral mediated~     suppression of NF-kB and disruption of viral latency.~   "
122447|NCT01964742|"~     The treatment of HCV (hepatitis C virus) infection has made significant progress over the~     past decade with the therapy combining pegylated interferon (Peg-IFN) to ribavirin (RBV). The~     cure of HCV infection which consists to obtain a sustained virological response (SVR)~     (undetectable HCV RNA 24 weeks after end of treatment) is reached in more than 50% of~     patients infected with HCV. However, this rate is much lower, around 30 to 40% in HIV-HCV~     co-infected patients and sometimes can be less than 20% for patients infected with HCV~     genotype 1. Haemolytic anemia is a dose-limiting adverse effect which occurs frequently under~     RBV therapy. RBV-induced anemia represents the main cause of treatment discontinuation or~     dose reduction of RBV, thus limiting the chances of achieving a SVR. RBV has a large~     inter-individual pharmacokinetic variability and a relationship between the occurrence of~     anemia and RBV concentration was clearly demonstrated. However, other factors, including~     genetic factors, could be predictive of hematotoxicity and/or a better efficiency. In~     particular, IL-28B polymorphism analysis, in patients infected with HCV genotype 1, before~     starting antiviral therapy could predict the response to treatment (positive predictive~     value). The genetic polymorphism of inosine triphosphate pyrophosphatase (ITPA) is also~     strongly associated to a protective effect towards the RBV-induced-anemia. But most of these~     data are issued from studies performed in a Japanese HCV mono-infected population treated~     with Peg-IFN-RBV therapy for which there is no other causal variant that the rs1127354. Only~     few studies are reported in the literature in caucasian HIV-HCV co-infected patients.~     Moreover, data on RBV plasma exposure are very scarce in all these studies showing an impact~     of the ITPA polymorphism on the occurrence of anemia. In addition, others polymorphisms of~     SCL29A1/A2 and SCL28A2/A3 coding for RBV transporters, ENT (equilibrative nucleoside~     transporter) et CNT (concentrative nucleoside transporter) would be associated to either~     rapid virological response or anemia in HCV infected patients treated by Peg-IFN plus RBV. No~     study considering both polymorphisms of ITPA, IL-28B, SCL29A1/A2 and SCL28A2/A3 genes and RBV~     plasma exposure data has so far been conducted in HIV-HCV co-infected patients.~      Thus, it would be interesting in a first time to assess the impact of the ITPA polymorphism~     on both the RBV plasma exposure and the protective effect towards RBV-induced anemia in~     HIV-HCV co-infected patients. This study could be helpful to the literature for possible~     further RBV dose adjustments according to ITPA activity.~      Then, it would be relevant to further complete these data by assessing other genetic~     polymorphisms as IL-28B, SCL29A1/A2 and SCL28A2/A3 and thus evaluate the overall~     pharmacogenetic relationships towards RBV-induced anaemia and/or virological response to a~     Peg-IFN/RBV therapy.~   "
122448|NCT01964729|"~     The purpose of this study is to investigate if rTMS may have a positive impact on pain~     thresholds and cortical excitability in subjects with chronic musculoskeletal diseases of~     complex cranio-cervical-mandibular with myofascial component.~   "
122449|NCT01964716|"~     This study will compare the immune responses of the infants who have been given 13vPnC in the~     mutidose vial formulation to the immune reponses of the infants who have been given 13vPnC in~     the single-dose syringe formulation.~      It will also evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in all~     infants who are vaccinated.~   "
122450|NCT01964703|"~     The purpose of this study is to determine whether Rubus occidentalis extract could improve~     fasting or postprandial serum glucose levels, and related metabolic markers among patients~     with prediabetes (impaired fasting glucose and/or impaired glucose tolerance).~   "
122451|NCT01964690|"~     Severe sepsis and septic shocks are increasingly codified. A biomarker as Lactate is very~     interesting to detect those situations. Usually, lactate used is arterial but results are~     often too slow to obtain if we want to respect Surviving Sepsis Campaign guidelines. Some~     analyzers (EKF diagnostics Lactate Scout*) can give results in 15 seconds.~      We hypothesized that capillary lactate, easy to sample, tested with this analyzer may detect~     earlier those infections states and we want to find the most accurate site to detect severe~     sepsis (capillary, venous or arterial sample).~   "
122452|NCT01964677|"~     The aim of this study is to evaluate effectiveness of the Philips Sonalleve MR-HIFU device~     for the palliation of pain in patients with bone metastases.~      Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) uses ultrasound~     to palliate pain caused by bone metastases. The main palliative mechanism of the method is~     due to local bone denervation, caused by the heat denaturation of the periosteum layer in the~     treated area. The importance of this therapy is that it offers a non-invasive, focal therapy,~     avoiding side-effects to surrounding normal tissue that occur with radiation therapy or the~     need for needle insertion as with radio-frequency(RF)ablation.~      The study hypothesis is that MR-HIFU will be effective in treating the pain associated with~     bone metastases~   "
122453|NCT01964664|"~     The purpose of this protocol is to (1) Determine whether a one-on-one mindfulness meditation~     intervention or audio training improves performance on an adaptive communication system that~     utilizes brain-computer interface (BCI); and (2) Determine whether the intervention reduces~     stress in subjects with severe speech and physical impairments (SSPI).~      Hypothesis: The group of subjects randomized to the mindfulness meditation training will~     improve BCI performance and stress levels more than the audio control group.~   "
122454|NCT01964651|"~     The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of~     JNJ-42165279 in healthy, young and elderly, male and female participants after repeated oral~     dose administration.~   "
122852|NCT01959451|"~     This study investigates whether a platelet function testing guided approach with a short-term~     (1 week) prasugrel treatment and a switch over to clopidogrel treatment in adequate~     responders to clopidogrel is non-inferior regarding the combined incidence of bleeding and~     thrombotic complications to a 12 month standard treatment with prasugrel in acute coronary~     syndrome (ACS) patients treated with percutaneous coronary intervention (PCI).~   "
122455|NCT01964638|"~     This is a prospective single center trial to examine the rates of cancer diagnosis when using~     computerized software to target suspicious lesions within the prostate identified on mpMRI.~     The primary evaluation involves comparing the rate of cancer diagnosis when using~     software-based MRI-Ultrasound image fusion guided biopsy to sample mpMRI findings to the use~     of visual guided biopsy (cognitive or mental targeting) of the same target. The hypothesis~     being tested is that fusion guided biopsy will increase detection prostate cancer within~     mpMRI findings as compared to visual guided biopsy of these areas~   "
122456|NCT01964625|"~     Graft versus Host Disease (GvHD), in both its acute and chronic forms, is the major intrinsic~     complication of allogeneic hematopoeitic stem cell transplant (allo-HSCT). Moreover, chronic~     GvHD may be regarded as a late effect of cancer therapy, and the severity of chronic GvHD~     is the chief determinant of long-term survival following allo-HSCT. Unfortunately, the~     investigators understanding (and thus management) of chronic GvHD is not optimal; a recent~     NIH Consensus Conference has defined inadequacies in virtually all facets of chronic GvHD~     management. Notably for this study, the lack of suitable biomarkers compromises diagnosis,~     staging and therapeutic response evaluation of chronic GvHD - and also hinders better~     understanding of the biology of this process.~      In particular, the activity of chronic GvHD is often difficult to discern, potentially~     causing either undertreatment, with the risk of morbidity and/or mortality due to~     uncontrolled chronic GvHD, or possibly overtreatment, with potent ISTs causing unnecessary~     toxicity. Obviously, the development of reliable biomarkers of chronic GvHD activity would be~     a very useful advance in addressing this problem, as well as other facets of management not~     addressed due to certain limitations, as detailed herein.~      Potentially, certain imaging technologies could address this problem. To date, imaging~     technology has been used only sporadically in chronic GvHD and is not an integral part of~     routine assessments. However, and despite its nonspecific nature, certain inflammatory~     features of some chronic GvHD cases, plus clinical similarity to certain autoimmune diseases~     in which functional imaging has been tested in research trials - (and perhaps notably), a~     limited experience in acute GvHD - the investigators postulate that Positron emission~     tomography - computed tomography (PET-CT) scans may be useful as a biomarker of disease~     activity in chronic GvHD. This protocol is an initial effort to that end.~   "
122457|NCT01964612|"~     Patient with chronic disease learning of a chronic illness quickly changes the way they~     encounter in physiological, psychological and social aspects. The investigators research~     purposes will use the meta-cognitive approach to explore adjustment to life-threatening~     illness (ex. hypertension and diabetes) of patients may find the important factors in their~     coping process.~   "
122458|NCT01964599|"~     The primary physiological impacts of fiber intake include the gastrointestinal effects of~     stool bulking, increased stool frequency and decreased gastrointestinal transit time (GTT).~     Fermentation of resistant starches by microbiota increases bacterial numbers, which increases~     fecal bulk and may impact frequency and transit time. The purpose of this study is to~     determine the effects of resistant potato starches (potato fiber) on stool frequency, transit~     time and microbiota in healthy individuals.~   "
122459|NCT01964586|"~     It is very important to decrease the bleeding during nasal septoplasty in order to increase~     the visibility of the surgical site. Our primary goal was to investigate the effects of~     dexmedetomidine and lidocaine plus adrenaline on visibility of surgical site and~     postoperative analgesic consumption.~   "
122460|NCT01964573|"~     The objective of this trial is to investigate the PK (Pharmacokinetic) of repeated-dose~     applications of the Rotigotine transdermal patch in healthy young male and female Korean~     subjects to be submitted to MFDS for new drug application approval.~   "
122461|NCT01964560|"~     Study to evaluate the long-term safety and tolerability of Lacosamide (LCM) administered in~     addition to 1 to ≤3 other Anti-Epileptic Drugs in subjects with epilepsy ≥1 month to ≤18~     years who currently have uncontrolled partial onset seizures.~   "
122462|NCT01964547|"~     A study to compare the change in cognitive performance and psychological status of patients~     with spasticity due to Multiple Sclerosis when treated with Sativex or placebo, added to~     existing anti-spasticity therapy over a period of 48 weeks. Secondary objectives were to~     evaluate the effect of Sativex on mood and spasticity and to assess the safety and~     tolerability of Sativex.~   "
122463|NCT01964534|"~     To evaluate the combination of ABI-007 with gemcitabine or with LV5FU2.~   "
122464|NCT01964521|"~     An open, non-comparative, multi-centre post marketing clinical follow-up, PMCF, investigation~     to evaluate performance and safety on diabetic foot ulcer, dfu, when using mepilex transfer~     Ag as intended.~   "
122465|NCT01964508|"~     Thyroid cancer is the most common endocrine malignancy and its incidence is rapidly~     increasing. Palpable thyroid nodules are very common, affecting up to 5% of the general~     population. Nevertheless, only 5% of the thyroid nodules harbor malignancy, hence the obvious~     need to accurately characterize these nodules. Ultrasound guided fine needle aspiration~     biopsy (FNAB) is the most important tool in assessing the nature of thyroid nodules, however,~     in up to 30% of the biopsies the results are indeterminate. In this proposal, we hypothesize~     that leftover cells in the FNAB needle may be utilized for molecular analysis with an~     established microRNA panel and distinguish between malignant and benign lesions. Despite~     established studies on the diagnostic utility of microRNAs in thyroid nodules, the effect of~     microRNAs on specific target genes involved in thyroid cancer is poorly studied. In this~     proposal we hypothesize that the microRNAs identified in our panel will affect intracellular~     pathways by regulating target genes that are involved in thyroid tumorigenesis. We present~     preliminary data that confirms that microRNA panel may identify malignancy in thyroid~     nodules. In aim 1 we will identify the expression profile of miRNAs in the different thyroid~     cancers. We will statistically quantify the threshold of miRNA dysregulation for malignancy~     on a large number of tumor and benign samples. This will serve as matrix for defining~     malignancy on the FNAB samples. In aim 2 we will establish a reliable reproducible method to~     extract RNA from cells left over in FNAB samples. Our preliminary data support the~     feasibility of the method and it has not been described previously. This will be the first~     study that will compare cytology results and microRNA panel analysis on the very same FNAB~     cells. It will mimic the exact clinical scenario that such microRNA panel can be utilized in~     the future. Finally, in aim 3 we will characterize the effect of microRNAs on target genes~     expression. We will identify possible target genes from bioinformatics databases and will~     perform quantitative measurement of mRNA level of target gene by real time PCR and~     immunohistochemistry. These studies will hopefully support the utility of microRNAs as a~     diagnostic tool to accurately identify malignancy in thyroid FNAB leftover cells and point~     out possible target genes for future therapeutic approaches. This could impact many patients,~     as thyroid cancer is the 5th most common cancer in women, and the most rapidly growing~     malignancy in both men and women.~   "
122466|NCT01964495|"~     The purpose of this study is to evaluate two different treatment strategies in patients~     admitted to hospital with Community Acquired Pneumonia. The investigators hypothesize~     treatment according to both procalcitonin (PCT) and C-reactive protein (CRP) will be~     effective in reducing the length of antibiotic treatment.~   "
122483|NCT01964274|"~     In this prospective, multicenter observational study the investigators capture the~     perioperative course of peripheral cholinesterase activity. The focus is the perioperative~     inflammation causing postoperative delirium. Therefore we measure the activity of~     Acetylcholine-Esterase and Butyrylcholine-Esterase in whole blood of adults in the~     perioperative context. Early postoperative delirium will be detected by Nu-DESC in the~     Recovery Room or the Postanaesthesia-Care-Unit. The course of the peripheral cholinesterase~     activity will be compared with the incidence of postoperative delirium and other clinical~     dysfunctions.~      We follow up the patients for up to five years regarding Delirum, comorbidities and mortality~     data.~   "
122467|NCT01964482|"~     The project aims to investigate the clinical value of simple strength training during~     hospitalization and after discharge as part of an enhanced recovery programme for acutely~     admitted older medical patients, in order to prevent mobility decline following acute~     hospitalization.~      Note 11/23/16: As noted in the protocol (doi: 10.1186/s13063-016-1309-1) we have obtained~     funding and ethical approval (H-2-2012-115/09-12-2016) to extend the study to achieve~     sufficient power to look more deeply into our secondary outcomes. This will constitute a~     secondary part of the trial (started Nov. 2016). The primary trial report will include data~     for the pre-specified sample size for which the last patient was assessed Oct. 2016. Hence,~     the primary completion date for part 1 was April 2016 and the study completion date for part~     1 was Oct 2016. The trial status is still recruiting although this applies to part 2 of the~     study.~   "
122468|NCT01964469|"~     This study is to compare Smart phone mobile device and/or web based application asthma action~     plan to the standard of care paper based asthma action plan within an asthma program. The~     Primary hypothesis: Health Outcome - The Breathe mobile health and web-based application~     improves asthma related quality of life more than conventional best practice~   "
122469|NCT01964456|"~     The purpose of this study is to demonstrate that bodily self-consciousness is subjectively~     and inter-subjectively constituted and that some dimensions of the bodily self-consciousness~     are impaired in Anorexia nervosa.~   "
122470|NCT01964443|"~     The purpose of this study is to explore the impact of plaque psoriasis on the different~     dimensions of patient life including psychological disorders, different types of addictions,~     and their consequences on health-related quality of life and socioeconomic parameters at~     baseline (cross-sectional part) and during the initial years of the psoriasis disease~     (longitudinal part).~   "
122471|NCT01964430|"~     The purpose of this study is to compare whether there is a delay or prevention of recurrence~     or death in subjects with surgically removed pancreatic cancer who then take nab-paclitaxel~     in combination with gemcitabine compared to those who take gemcitabine alone.~   "
122472|NCT01964417|"~     The purpose of this study is to compare the efficacy, acceptability and preparation-induced~     mucosal inflammation of PEG + ascorbic acid vs. PEG for colonoscopy.~   "
122473|NCT01964404|"~     Substance use disorders are strikingly common in patients with schizophrenia and contribute~     to its morbidity and cost to society. We have proposed a neurobiological formulation~     suggesting that cannabis and other substance use in these patients may ameliorate a~     dysfunction in the brain reward circuit(thus serving a self-medication function), while~     also worsening the symptoms and course of schizophrenia.~      In this translational research proposal, based on our formulation, we seek to confirm and~     expand upon data obtained in our pilot study suggesting that cannabis and the cannabinoid~     agonist dronabinol, given in low dose to patients with schizophrenia and co-occurring~     cannabis use disorder, will in fact ameliorate the brain reward circuit dysregulation in~     these patients and, thereby, provide evidence in support of the role of cannabis as a~     self-medication agent for them. Also, by also testing the full range of effects produced by~     dronabinol (effects on brain reward circuitry assessed with task-based function MRI and~     resting state connectivity), as well as on reward responsiveness, mood, craving, cognition,~     psychiatric and extrapyramidal symptoms), we will provide clues as to whether dronabinol~     should be tried in low doses as an adjunctive agent (with an antipsychotic medication) to~     limit cannabis use in patients with schizophrenia.~      Substance use disorders are strikingly common in patients with schizophrenia and contribute~     to its morbidity and cost to society. We have proposed a neurobiological formulation~     suggesting that cannabis and other substance use in these patients may ameliorate a~     dysfunction in the brain reward circuit(thus serving a self-medication function), while~     also worsening the symptoms and course of schizophrenia.~      In this translational research proposal, based on our formulation, we seek to confirm and~     expand upon our pilot data suggesting that cannabis and the cannabinoid agonist dronabinol,~     given in low dose to patients with schizophrenia and co-occurring cannabis use disorder, will~     in fact ameliorate the brain reward circuit dysregulation in these patients and, thereby,~     provide evidence in support of the role of cannabis as a self-medication agent for them.~     Also, by also testing the effects produced by dronabinol (effects on brain reward circuitry~     assessed with task-based function MRI and resting state connectivity), as well as on reward~     responsiveness, mood, craving, cognition, psychiatric and extrapyramidal symptoms), we will~     provide clues as to whether dronabinol should be tried in low doses as an adjunctive agent~     (with an antipsychotic medication) to limit cannabis use in patients with schizophrenia.~      This study will involve 8 groups of 25 participants each. Groups 1-3 will have diagnoses of~     schizophrenia and cannabis use disorder; Group 4 will have schizophrenia only, Groups 5-7~     will have cannabis use disorder only and Group 8 will be healthy control participants.~     Following screening and baseline neuropsychiatric testing, participants will have two tests~     days (T1 and T2) that will include task-based functional MRI, including assessment of resting~     state connectivity, and measuring a number of other parameters including reward~     responsiveness, mood, craving, symptoms and cognition. The assessments at T1 will be~     virtually the same for all groups. At T2 Groups 1-3, and Groups 5-7 will be randomly assigned~     to one of the following conditions prior to the assessments: receiving 15mg of dronabinol and~     smoking a placebo marijuana cigarette, receiving a placebo pill and smoking a real marijuana~     cigarette, or receiving a placebo pill and smoking a placebo marijuana cigarette. Group 4 and~     Group 8 will receive no drug or placebo at T2. Participants receiving drug will have safety~     assessments before the drug is administered, after the drug is administered but before~     leaving the research clinic for the day, and again a week later.~   "
122474|NCT01964391|"~     This Phase IIIb, open-label, multinational, multicenter study will evaluate the participant's~     satisfaction and safety with subcutaneously administered trastuzumab in participants with~     HER2-positive early breast cancer. Participants will receive trastuzumab 600 milligrams (mg)~     administered subcutaneously every 3 weeks in the adjuvant or neo-adjuvant plus adjuvant~     setting for 18 cycles (1 year), unless disease progression or unacceptable toxicity occurs.~     The trastuzumab regimen could include mono- and/or combination therapy.~   "
122475|NCT01964378|"~     Pain is one of the most common symptoms associated with malignant tumor. The purpose of this~     trial is to determine whether cebranopadol is as effective in patients with cancer related~     pain as morphine sulfate prolonged release.~   "
122476|NCT01964365|"~     The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug~     interaction between rosuvastatin and fenofibric acid in healthy adult subjects~   "
122477|NCT01964352|"~     The objective of this study is to assess the efficacy and safety of 12 weeks once daily~     treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the Respimat inhaler)~     compared with tiotropium and placebo in patients with COPD.~   "
122478|NCT01964339|"~     This is an observational study to characterize the prevalence of Obesity Hypoventilation~     Syndrome in patients referred to the sleep lab.~   "
122479|NCT01964326|"~     The purpose of this actual use study is to simulate the over the counter use of atorvastatin~     calcium 10 mg.~   "
122480|NCT01964313|"~     To describe the role of genetic factors and its relationship and interaction with~     environmental factors in the recurrence of cardiac events in Chinese patients with acute~     coronary syndrome.~   "
122481|NCT01964300|"~     This phase II trial studies how well peginterferon alfa-2b works in treating younger patients~     with craniopharyngioma that is recurrent or cannot be removed by surgery. Peginterferon~     alfa-2b may interfere with the growth of tumor cells and slow the growth of~     craniopharyngioma.~   "
122482|NCT01964287|"~     Based on conventional chemotherapy approach, data have indicated that the Folfirinox regimen~     is more effective and tolerate than the treatment by Gemcitabine alone in patients with~     metastatic pancreatic adenocarcinoma. A recent study combining gemcitabine and nab paclitaxel~     improve the objective response rate.~      Primary objective of this study is to identify the maximun tolerated dose and the recommended~     phase II dose of first line treatment combining gemcitabine plus nab-paclitaxel followed by~     folfirinox in metastatic pancreatic adenocarcinoma.~   "
122866|NCT01959269|"~     The purpose of the study is to investigate the safety and effectiveness of Stivarga in~     patients with metastatic colorectal carcinoma in routine use in Germany. The study is purely~     observational, only data from routine treatment are to be collected. The treatment and~     treatment conditions are solely at discretion of the treating physician.~   "
122484|NCT01964261|"~     This research study is being conducted to develop a brain controlled medical device, called a~     brain-machine interface. The device will provide people with a spinal cord injury some~     ability to control an external device such as a computer cursor or robotic limb by using~     their thoughts along with sensory feedback.~      Development of a brain-machine interface is very difficult and currently only limited~     technology exists in this area of neuroscience. Other studies have shown that people with~     high spinal cord injury still have intact brain areas capable of planning movements and~     grasps, but are not able to execute the movement plans. The device in this study involves~     implanting very fine recording electrodes into areas of the brain that are known to create~     arm movement plans and provide hand grasping information and sense feeling in the hand and~     fingers. These movement and grasp plans would then normally be sent to other regions of the~     brain to execute the actual movements. By tying into those pathways and sending the movement~     plan signals to a computer instead, the investigators can translate the movement plans into~     actual movements by a computer cursor or robotic limb.~      A key part of this study is to electrically stimulate the brain by introducing a small amount~     of electrical current into the electrodes in the sensory area of the brain. This will result~     in the sensation of touch in the hand and/or fingers. This stimulation to the brain will~     occur when the robotic limb touches the object, thereby allowing the brain to feel what the~     robotic arm is touching.~      The device being used in this study is called the Neuroport Array and is surgically implanted~     in the brain. This device and the implantation procedure are experimental which means that it~     has not been approved by the Food and Drug Administration (FDA). One Neuroport Array consists~     of a small grid of electrodes that will be implanted in brain tissue and a small cable that~     runs from the electrode grid to a small hourglass-shaped pedestal. This pedestal is designed~     to be attached to the skull and protrude through the scalp to allow for connection with the~     computer equipment. The top portion of the pedestal has a protective cover that will be in~     place when the pedestal is not in use. The top of this pedestal and its protective cover will~     be visible on the outside of the head. Three Neuroport Arrays and pedestals will be implanted~     in this study so three of these protective covers will be visible outside of the head. It~     will be possible to cover these exposed portions of the device with a hat or scarf.~      The investigators hope to learn how safe and effective the Neuroport array plus stimulation~     is in controlling computer generated images and real world objects, such as a robotic arm,~     using imagined movements of the arms and hands.~   "
122485|NCT01964248|"~     The aim of the study is to evaluate the interest of Local Anesthesia (lidocaïne/prilocaïne~     versus placebo)before arterial puncture for Blood Gas Analysis. The pain is measured with a~     numeric Pain Intensity for all patients included.~   "
122486|NCT01964235|"~     This study is establish whether INC280 is safe and has beneficial effects in patients with~     advanced hepatocellular carcinoma known to have dysregulation of c-MET pathway and whose~     disease progressed while on, or after, treatment with sorafenib or who are intolerant to~     sorafenib.~      Patients will be randomized in a 2:1 ratio to receive INC280 at 600mg BID plus best~     supportive care (BSC) or placebo plus BSC, until disease progression or intolerable to study~     treatment. Patients treated with placebo plus BSC will have the opportunity to receive INC280~     treatment upon documented further disease progression (RECIST 1.1) per investigator's~     discretion after unblinding.~      Patient will be stratified to geographical region (Asia vs Rest of World ) and tumor burden~     (present macroscopic vascular invasion and/or extra-hepatic spread vs not present).~   "
122487|NCT01964222|"~     This study will update an existing health literacy intervention (decision aid) for informed~     consent procedures and then conduct a randomized experiment implementing the health literacy~     intervention at Siteman Cancer Center and evaluate its effectiveness compared to usual care.~     Our hypothesis is that implementing the targeted, web-based decision aid (DA) in addition to~     usual care will increase knowledge about cancer clinical trials. Secondary outcomes include~     patients' ability to communicate with health care providers about trials, willingness to~     participate in trials, and enrollment rates for minority participants.~   "
122488|NCT01964209|"~     This proposal is to evaluate the reliability and validity of the Vanderbilt ADHD screening~     tool for use with adolescents and young adults aged 13-21 years. The Vanderbilt is a~     previously developed, freely available set of parent- and teacher-report questionnaires~     designed to identify ADHD and related disorders in children. The Vanderbilt measures have~     been chosen for inclusion in the new computerized Integrated Clinical Information Sharing~     System (ICISS) being rolled out in five Boston Children's Hospital (BCH)~     departments/divisions (Adolescent/Young Adult Practice, Children's Hospital Primary Care~     Center, Developmental Medicine Center, Department of Neurology, Department of Psychiatry).~     The Vanderbilt was developed and validated for use among children up to age 12 years~     (Wolraich et al., 2003; Wolraich et al., 2013; Bard et al., 2013), and little is known about~     its appropriateness for use among older youth. In addition, there is no self-report version~     of the Vanderbilt that can be administered directly to adolescents and young adults (ages~     13-21 years), for whom parents and teachers are often less knowledgeable reporters. To~     address these shortcomings, a multidisciplinary team of BCH adolescent health clinicians and~     researchers modified the parent and teacher Vanderbilt questionnaires to make them~     age-appropriate for adolescents and young adults and created a complementary self-report~     version for adolescents and young adults. The goal of the current study is to 1) assess the~     feasibility and acceptability of online administration through the ICISS system of the new~     parent, teacher, and youth self-report Vanderbilt measures among adolescent and young adult~     BCH patients aged 13-21 years; 2) test their reliability in terms of internal consistency~     reliability, temporal stability of responses over a one-month test-retest, and inter-rater~     agreement across all informants (parents, teachers, and youths); and 3) test their validity~     by evaluating their convergence with a similar set of ADHD screening tools, the Conners~     scales, already validated for use with adolescents and young adults.~   "
122489|NCT01964196|"~     This study is to evaluate the safety and the dose-response of ASP1517 in the treatment of~     anemia in non-dialysis Chronic Kidney Disease (CKD) patients when ASP1517 is applied~     intermittently.~   "
122490|NCT01964183|"~     To assess the effect of multiple doses of mirabegron to postmenopausal adult female subjects~     on the pharmacokinetics (PK) of tolterodine and its metabolites.~      In addition, the safety of these products will be assessed.~   "
122491|NCT01964170|"~     To compare the efficacy and safety of ASP3550 to goserelin acetate in patients with prostate~     cancer.~   "
122492|NCT01964157|"~     ROS1 is a receptor tyrosine kinase with constitutive kinase activity. ROS1 was previously~     discovered in cell lines where ROS1 fused with other proteins to act as a driver oncogene. In~     2007, Rikova et al reported ROS1 fusion as driver mutations in NSCLC cell line (HCC78;~     SLC34A2-ROS1) and NSCLC patient (CD74-ROS1). Li et al also found about 1% of samples~     harboring CD74-ROS1 fusion in 202 resected lung adenocarcinomas from never smokers. The~     incidence was as high as 10% in East Asian population. Currently there are now at least 13~     ROS1 fusion variants involving 8 fusion partners (CD74-, SLC34A2-, FIG-, TPM3-, SDC4-,~     LRIG3-, ERZ-, KDERL2-) identified in ROS1 positive NSCLC. LDK378 is an orally highly~     selective and potent ALK kinase inhibitor. In preclinical studies, LDK378 has much lower IC50~     values than crizotinib in cell lines engineered to express ROS1 rearrangement (0.15 nM versus~     3 nM) and is approximately 20-fold more potent. LDK378 is a potent inhibitor of tumor growth~     in rodent models of both ALCL and NSCLC. We suggest a phase II trial of LDK378 in advanced~     non-small cell lung cancer patients with ROS1 rearrangement. The aim of current trial is to~     evaluate the antitumor efficacy and safety profile of LDK378 and to identify biomarker to~     predict the tumor response to LDK378.~   "
122493|NCT01964144|"~     There has been no effective treatment for advanced thyroid cancer that is not amenable to~     surgery and that does not concentrate iodine. Response rates with chemotherapy have been so~     low that best supportive care has been the standard of care for most patients. In recent~     phase I and phase II clinical studies, dovitinib has shown activity as a single agent in~     solid tumors. Therefore, we will conduct a phase II, single-arm trial to determine the~     efficacy of dovitinib in radioactive iodine-refractory recurrent or metastatic thyroid~     cancer.~   "
122498|NCT01964079|"~     Blood pressure (BP) is believed to be a major determinant of vascular disease, and BP~     lowering is the most important goal in hypertension treatment. Thus, clinical guidelines for~     hypertension are mainly focused on lowering mean BP. However, despite an increasing incidence~     of stroke with age, the association between systolic BP (SBP) and the risk of stroke~     decreases with age. This disparity highlights a gap in the link between BP and~     vascular-related diseases (i.e., stroke). In clinical practice, visit-to-visit fluctuations~     in BP have been largely ignored and are thought to be an unreliable finding, even though this~     phenomenon is frequently observed. Rothwell et al. demonstrated that the visit-to-visit~     variability in SBP was a more powerful independent predictor of stroke than mean SBP, and~     that an increased residual variability in SBP in treated hypertensive patients was also a~     strong predictor of stroke and coronary events.~      Recently updated (2011) hypertension guidelines from the National Institute for Health and~     Clinical Excellence (NICE) recommend an angiotensin converting enzyme inhibitor (ACEi) [or~     angiotensin II receptor blocker (ARB)] and calcium-channel blocker (CCB) as a first line~     drug. Although the significance of BP variability (BPV) has been illustrated, the main focus~     of the current guidelines is to reduce systolic and diastolic BP, not BPV.~      In the X-CELLENT study, a CCB (amlodipine) and thiazide-like diuretic drug (indapamide~     sustained-release) led to a significant reduction in BPV, compared to an ARB (candesartan).~     In addition, the CCB showed the most effective reduction in systolic BPV among the~     antihypertensive drug class in a meta-analysis. However, there are no direct comparison~     studies of a CCB and ARB on BPV. Thus, we aim to compare the systolic BPV effects of a CCB~     versus an ARB in essential hypertensive patients. The primary hypothesis is that an ARB is~     not inferior to a CCB in the reduction of the systolic BPV standard deviation (SD) in~     essential hypertensive patients.~   "
122499|NCT01964066|"~     For 40 years, the post-ERCP (endoscopic retrograde cholangiopancreatography) pancreatitis has~     been the most frequent adverse effect of endoscopic transpapillary interventions. We sought~     to determine the efficacy of thoracic epidural analgesia for the prevention of post-ERCP~     pancreatitis.~      Between 2008 and 2013, a randomized study of the results of endoscopic treatment of 491~     patients was conducted. The first group of patients (N=247) received thoracic epidural~     analgesia (TEA) during ERCP procedures, the patients of the second group (N=244) received a~     narcotic analgesic. To detect statistically significant differences between research groups~     adjusted odds ratios (OR) and their 95% confidence interval (CI) were calculated.~   "
122500|NCT01964053|"~     Non-adherence to self-management behaviors is prevalent and accounts for hospital~     readmissions in heart failure (HF) patients 65 years of age and older. The mechanism to~     activate and engage HF patients in managing their own care is uncertain. Yet post-acute care~     service that is vital to improve HF patients' self-management adherence and HF outcomes is~     suboptimal in rural hospitals (primarily critical access hospitals). The investigators~     central hypothesis is that patients with higher activation level will have significantly~     better self-management adherence. This study will test whether Patient AcTivated Care at Home~     (PATCH) will improve self-management adherence and health outcome (reduced hospital~     readmissions), as well as the feasibility to translate the research findings to a home based~     post-acute care service in rural communities.~   "
122501|NCT01964040|"~     The duration of sensory block after single dose of long acting local anesthetics is not~     sufficient to avoid the postoperative use of opioids. Alpha-2 adrenoceptor agonists such as~     clonidine have been shown to increase the duration of peripheral nerve block. Dexmedetomidine~     is a more potent and selective α-2-adrenoceptor compared to clonidine. To the best of our~     knowledge, the use of Dexmedetomidine as adjuvant to local anesthetic was not previously~     reported for femoral nerve block.~   "
122502|NCT01964027|"~     This study is to determine the response rate and safety profile of irinotecan plus epirubicin~     as the second-line chemotherapy for advanced gastric cancer and fully evaluate the~     feasibility and effectiveness of the regime.~   "
122503|NCT01964014|"~     The objective of this study is to assess the efficacy and safety and Immunosuppressant~     Therapy Barrier Scale (ITBS) of once daily immunosuppressant maintenance therapy in patients~     who had kidney transplantations earlier.~   "
122504|NCT01964001|"~     Carcinoma is the leading cause of worldwide. Hepatocellular carcinoma (HCC) is the second~     cause of cancer mortality in Taiwan. Vitamin B-6 and coenzyme Q10 has been recognized as~     antioxidants and anti-inflammatory nutrients in recent clinical studies. The purposes of this~     study are going to investigate the relation of vitamin B-6 and coenzyme Q10 with the~     indicators of oxidative stress, antioxidant enzymes activities and the inflammatory markers~     in patients with stage 1 and stage 2 HCC. The study is designed as an intervention study. The~     investigators will recruit HCC patients with stage 1 and stage 2 (n = 150) who are identified~     by liver biopsy. HCC subjects are randomly assign to placebo, vitamin B-6 (50 mg/d), coenzyme~     Q10 (300 mg/d), and vitamin B-6 plus coenzyme Q10 supplements groups. Intervention is going~     to administration for three months. The concentrations of vitamin B-6, coenzyme Q10,~     oxidative stress indicators, antioxidant enzymes activities, antioxidant vitamins (vitamin A~     and E), and inflammatory markers are going to be analyzed. The results would provide more~     information nutrients for clinical physicians and dietitians for considering suggesting~     patients with HCC using vitamin B-6 or coenzyme Q10 supplementation to improve their clinical~     outcomes.~   "
122505|NCT01963988|"~     On the EAU (European Association of Urology) guidelines, the ulcer type bladder pain syndrome~     (BPS) should be treated with transurethral resection (TUR) or coagulation (TUC) of ulcer.~      But, Up to date, there was no study to compare the therapeutic efficacy of TUR with TUC in~     ulcer type BPS patients.~      We assume TUR have a more therapeutic effect than TUC.~   "
122506|NCT01963962|"~     The purpose of this study is to see how often women who come to a family planning clinic for~     emergency contraception, the morning after pill, are willing to use either the copper IUD or~     the levonorgestrel IUD. The investigators will also see if pregnancies occur in those~     choosing the levonorgestrel IUD and if people continue to use the IUD for 1 year.~   "
122507|NCT01963949|"~     To collect tumor tissue from patients with liver masses suspicious for primary liver cancer.~     The research biopsy will be used to identify biomarkers in future studies.~   "
122548|NCT01963416|"~     Acute, randomized, placebo controlled, double blind, postprandial crossover study in male~     subjects. 4 intervention arms consisting of control, orange juice, whole orange, and~     processed whole orange to determine the effect of the interventions on the primary measure of~     flow mediated dilatation (FMD) and additional biomarkers of health. The study will also~     identify and quantify the main micronutrients and phytochemicals in each of the products and~     will identify and quantify the main micronutrients and phytochemicals and their metabolites~     in the subjects' plasma and/or urine. A subset of the study population (n=24) will be invited~     to participate in an additional arm of the main study which is summarised below.~   "
122508|NCT01963936|"~     Laryngeal mask airways (LMA) that fit over the laryngeal inlet have been shown to be~     effective for ventilating newborns at birth. The LMA may be considered as an alternative to~     FM for positive pressure ventilation (PPV) among newborns weighing >2000 g or delivered >34~     weeks' gestation.~      A recent, quasi-experimental study provided the feasibility, efficacy and safety of using the~     LMA in neonatal resuscitation.~      However, studies of LMA use for providing PPV during neonatal resuscitation are still~     limited. There are no published clinical randomized trials evaluating the LMA compared with~     the FM for neonatal resuscitation.~      Hypothesis: Our hypothesis is based on the assumption that ventilating newborns needing PPV~     with a LMA will be more effective than ventilating with a FM by decreasing the proportion of~     resuscitated newborns needing ETT.~      Objective: To compare the effectiveness of LMA and FM ventilation in newborns needing PPV at~     birth.~      Design / Methods: An open, prospective, randomized, single center, clinical trial.~      Intervention: PPV will be performed with a LMA (intervention group) or with a FM (control~     group) in all infant newborns weighing >2000 g or delivered >34 weeks gestation.~      Primary outcome variable: Proportion of newborns needing endotracheal intubation.~      Secondary outcome measures: Apgar score at 5 minutes, heart rate at 60, 90 seconds and 5 and~     10 minutes, time to first breath, duration of PPV, for proportion of infants needing chest~     compressions, drugs and death within 1 week and/or presence of HIE, grade II or III,~     according to a modification of Sarnat and Sarnat.2,10 According to this classification, HIE~     grade I (mild) includes irritability, hyperalertness, mild hypotonia, and poor sucking; grade~     II (moderate) includes lethargy, seizures, marked abnormalities of tone, and requirement of~     tube feeding; and grade III (severe) includes coma, prolonged seizures, severe hypotonia, and~     failure to maintain spontaneous respiration.~      The following data were collected during resuscitation: (1) Apgar score at 1 min and 5 min~     after birth; (2) LMA insertion time, the rate of successful insertion at the first attempt,~     and the number of attempts required to insert the LMA successfully; (3) duration of~     resuscitation: response time (the time period from starting LMA resuscitation to achieving an~     effective response), ventilation time; (4) adverse effects during resuscitation.~   "
122509|NCT01963923|"~     The purpose of this study is to establish the effectiveness of a preoperative pulmonary~     rehabilitation program in patients awaiting lung resection for lung cancer by Video-assisted~     thoracic surgery in order to improve exercise tolerance and quality of life. The~     investigators hypothesized that a pulmonary rehabilitation program including both endurance~     and strength training may improve exercise tolerance and quality of life measured with a~     submaximal exercise test and a quality of life questionnaire respectively.~   "
122510|NCT01963910|"~     Capsaicin is a TRPV1 (transient receptor potential vanilloid 1) agonist, causing pain upon~     application. The investigators wish to determine whether mannitol blocks the effect of~     capsaicin application. As both cream bases are identical and mannitol addition is the only~     difference between the creams, if the mannitol cream is more effective in blocking the effect~     of capsaicin on the TRPV1 (transient receptor potential vanilloid 1) receptor, the~     investigators will have established that mannitol down-regulates or blocks the TRPV1~     (transient receptor potential vanilloid 1) receptor.~   "
122511|NCT01963897|"~     The study will give a consent based epidemiological overview of Norwegian patients with~     Duchenne muscular dystrophy younger than 18 years of age. Genotype of the population will be~     described. Longitudinal development of growth, bone health, and , when applicable, puberty~     over a two year period will be studied. Questionnaires regarding quality of life will also be~     an important part of the study.~   "
122512|NCT01963884|"~     In patients that are going to be subjected to a tooth extraction in the anterior maxillary~     (from canine to canine) does the position of the intact alveolar socket related to maxillary~     basal bone interferes with the rate of resorption and remodeling process of the alveolar~     ridge ?~   "
122513|NCT01963871|"~     The purpose of this study is to determine if yoga is an effective intervention in treating~     individuals with chronic low back pain (LBP).~   "
122514|NCT01963858|"~     Patient attending for colonoscopy are generally worried and anxious. Fear of discomfort is~     the most common reason for low acceptance of colonoscopy. Several methods have been used to~     minimize patient discomfort, including the use of paediatric colonoscopes, variable stiffness~     colonoscopes, gastroscopes, music, audio distraction, or simply allowing the patients to~     participate in administration of medication. Although a potential benefit from some of these~     methods has been suggested, no clear recommendations have been made so far. We hypothesized~     functional relaxation reduces discomfort during colonoscopy.~   "
122515|NCT01963845|"~     Nonalcoholic fatty liver disease (NAFLD) represents a spectrum of diseases ranging from~     simple steatosis to nonalcoholic steatohepatitis (NASH), the progressive form of liver~     disease that can lead to cirrhosis and liver-related mortality in persons who drink little or~     no alcohol. NAFLD is defined as the presence of hepatic steatosis with no evidence of~     hepatocellular injury in the form of ballooning of the hepatocytes. NASH is defined as the~     presence of hepatic steatosis and inflammation with hepatocyte injury (ballooning) with or~     without fibrosis. NASH is benign in many affected individuals but can cause progressive liver~     injury and, indeed, may be the major cause of cryptogenic cirrhosis1. Currently, there is no~     FDA approved treatment for NAFLD. Weight loss and exercise are the recommended but often~     difficult maintain these lifestyle changes in the long term and therefore therapeutic agents~     have been investigated. In this study, we propose to treat 50 patients with NAFLD and~     diabetes with either sitagliptin or placebo for 24 weeks. After an initial evaluation for~     insulin sensitivity and MRI liver fat distribution, patients will receive either 100 mg/day~     of sitagliptin or placebo. Patients will be monitored at regular intervals for symptoms of~     liver disease, side effects of sitagliptin and serum biochemical and metabolic indices. At~     the end of 24-weeks, patients will have a repeat medical evaluation, liver MRI and an~     optional liver biopsy. Pre and post treatment MRI-derived liver fat content and insulin~     sensitivity will be compared. The primary end point of successful therapy will be improvement~     in hepatic steatosis measured by MRI. Secondary end points will be improvement in insulin~     sensitivity and liver biochemistry.~   "
122516|NCT01963832|"~     Stroke patients who have little or no voluntary movement in the hand on the more affected~     side of their body more than one year after stroke have few treatment options. This project~     proposes to test the efficacy of a form of Constraint-Induced Movement therapy designed for~     patients with such severe impairment in conjunction with an agent, fluoxetine, which has been~     shown in some studies to enhance brain neuroplasticity in response to training.~     Constraint-Induced Movement therapy, which is abbreviated CIMT, is a form of physical~     rehabilitation based on basic research in neuroscience and behavioral science. If the project~     is successful, an efficacious, evidence-based therapy will become available to stroke~     patients for what is now a largely untreated condition~   "
122517|NCT01963819|"~     The aim of this study is to evaluate the potential benefits in implantation, clinical~     pregnancy and live birth rates by an endometrial biopsy prior to an IVF/ICSI treatment.~     Including a follow up on possible pregnancy complications and data on children at birth.~      Further it is planned to aspirate secretions from the uterus and take blood samples during~     the treatment, which presumably can provide information about the mechanisms underlying the~     possible effect of the treatment.~   "
122518|NCT01963806|"~     BACKGROUND: Smartphone technology presents a novel and promising opportunity to extend the~     reach of psychotherapeutic interventions by moving selected parts of the therapy into the~     real-life situations causing distress. This randomised controlled trial will investigate the~     effect of a transdiagnostic, Internet-administered cognitive behavioural (iCBT) self-help~     program for anxiety, supplemented with a tailored smartphone application. The effect of added~     therapist support will also be studied.~      METHODS/DESIGN: 150 participants meeting diagnostic criteria for social anxiety disorder~     and/or panic disorder will be evenly randomised to one of three treatment arms: (1)~     smartphone-supplemented iCBT with therapist support; (2) smartphone-supplemented iCBT without~     therapist support; or (3) an active waiting list control group with delayed treatment. After~     the 10 week treatment period, the control group (3) will receive the same treatment as group~     (2). Primary outcome measure will be the Generalised Anxiety Disorder 7-item self-rating~     scale. Secondary measures include other anxiety, depression and quality of life measures. In~     addition to pre- and post-treatment measurements, the study includes two mid-treatment and~     two follow-up assessments (12 and 24 months).~      HYPOTHESES: Based on prior research, we hypothesise that the therapist-guided form will be~     superior to the unguided form in reducing anxiety levels, and that both delivery modes will~     be superior to an active waiting-list control group.~   "
122519|NCT01963793|"~     Topical Aprepitant in Prurigo Patients - An Exploratory Phase IIa Trial With Topically~     Applied Aprepitant in Patients With Prurigo~   "
122520|NCT01963780|"~     To evaluate the safety and effectiveness of the OCS™ Lung to recruit, preserve and assess~     donor lungs that may not meet current standard donor lung acceptance criteria for~     transplantation.~   "
122521|NCT01963767|"~     Interventions to improve the cognitive health of older adults are of critical importance. In~     the current protocol, ithe investigators conducted a short-term (two months) randomized~     clinical trial to examine the influence of the nutraceutical NT-020 on the cognitive~     performance of older adults. Participants were tested with a battery of cognitive tasks at~     baseline and two months after being randomized to the interventional drug or placebo.~   "
122522|NCT01963754|"~     In patients that are going to receive a dental implant in the posterior mandible (distal from~     canine), does the subperiosteal anesthetic technique with Articaine 1:100.000 4 % Epinephrine~     compared to the loco-regional one, produces the same analgesia during surgery ?~   "
122523|NCT01963741|"~     Leukotrienes play critical roles in the inflammatory process in allergic rhinitis and~     bronchial asthma, therefore, anti-leukotriene therapy is part of treatment for asthma.~     However, not all allergic rhinitis accompanied with or without asthma treated with~     anti-leukotriene were effective. So it is critical to develop a method to identify the~     response subgroup. In this study, it is assumed that nasal physiological responsiveness to~     leukotriene nasal provocation test (NPT) is able to gain evidence on the effect of~     leukotriene on the development of allergic rhinitis and asthma, and is helpful to the use of~     anti-leukotriene agent. The purpose of the study is to establish the methodology and~     diagnostic value of leukotriene D4 (LTD4) nasal provocation.~   "
122524|NCT01963728|"~     To determine if the use of insulin isophane results in improved control of blood sugars~     compared to the use of insulin glargine in new onset diabetes after kidney, lung, or heart~     transplantation (NODAT).~   "
122525|NCT01963715|"~     This is a Phase 1, first-in-human study to determine the recommended dose of IMGN289 in adult~     patients with advanced EGFR-positive tumors.~   "
122526|NCT01963702|"~     Platinum, fluorouracil and taxane based regimen are all acceptable in the first line~     treatment of metastatic gastric cancer. The TX and XELOX regimen are two common regimen used~     in MGC. whichever regimen is used, the average response rate is less than 50%. So a rather~     part of patients can't get benefit from the treatment. It is urgent to find out the~     predictive factors of these regimens in order to get a higher response and better survival~     outcome.~   "
122527|NCT01963689|"~     The aim of this study was to determine whether the use of Ylang Ylang essential oil through~     dermal application or inhalation alters the perception of anxiety and self-esteem and~     physiological parameters such us blood pressure and temperature.~   "
122528|NCT01963676|"~     Investigating the effect of non-invasive transcranial current stimulation on auditory~     hallucinations in patients with schizophrenia. Normal neuronal activity is perturbed in~     schizophrenia, so selective targeting of this abnormal activity could serve as a treatment~     for schizophrenia and alleviate symptoms caused by abnormal neuronal activity, such as~     auditory hallucinations.~   "
122529|NCT01963663|"~     Patients with type 2 diabetes are at an increased risk for developing atherosclerosis,~     largely due to the underlying insulin resistance and chronic low grade inflammation.~     Cardiovascular events could be prevented with proper interventions targeted at ameliorating~     the aforementioned detrimental processes. YKL-40, a novel surrogate marker of acute and~     chronic inflammatory states has been implicated to have a putative role in both pathways.~     Given the shared pathway of insulin resistance and atherosclerosis, it is conceivable that~     anti-diabetes medications are able to modify coronary artery disease risk via direct and~     indirect amelioration of YKL-40 concentrations. The present clinical trial was therefore~     launched to examine the comparative effects of metformin and pioglitazone, two commonly~     prescribed anti-diabetes medications on YKL-40 concentrations in medication-naïve,~     newly-diagnosed type 2 diabetes patients.~   "
122530|NCT01963650|"~     The purpose of this study is evaluate the natural course of disease progression related to~     gross motor function in children with metachromatic leukodystrophy (MLD).~   "
122542|NCT01963494|"~     Regular physical activity is one prominent health-protective behaviour which might increase~     with the help of self-regulatory strategies such as action planning.~      The aim of this randomised controlled trial is to examine changes in daily moderate physical~     activity in couples following (a) a dyadic planning intervention, (b) an individual planning~     intervention or (c) a no-planning control condition. Changes in daily physical activity will~     be examined over a period of one year.~      It is assumed that target persons from couples receiving a dyadic planning intervention will~     show greater increases in daily physical activity than target persons from couples receiving~     an individual planning intervention. For couples receiving a dyadic planning intervention or~     an individual planning intervention, it is hypothesized that target persons will show higher~     increases in daily physical activity than target persons from couples participating in the~     no-planning control condition.~   "
122531|NCT01963637|"~     The Gastric bypass (GBP) is actually one of the most performed bariatric procedures~     worldwide. Short term results report 67% of mean Excess Weight Loss (EWL) at 2 years, and 58%~     EWL at 5 years. Sleeve gastrectomy (SG) which is a restrictive procedure has gained in~     popularity because of its technical simplicity and its efficiency (60% EWL at 1 year and 48%~     over 4 years). However, failures are observed because of insufficient weight loss or early~     weight regain. Several hypotheses have been proposed to explain these failures, such as the~     size of the gastric pouch that could be correlated to weight evolution.~      Purpose of the study Taking the hypothesis that a progressive dilatation of the gastric pouch~     is one of the main factors of weight loss failure after GBP or SG due to the loss of its~     restrictive function, the aim of our study is to measure these gastric volumes using gastric~     tomodensitometry with gas, a new reliable,precise and 3 dimension radiological technique. The~     investigators will try to identify a positive correlation between gastric dilatation and~     weight regain.~      Methods This is a 2 year interventional, prospective, monocentric study with longitudinal~     follow-up. Forty-five obese patients (BMI>40kg/m²) eligible for primary GBP (n=25) or SG~     (n=20) will be included. Gastric volumes will be measured by gastric tomodensitometry with~     gas at 3 and 12 month after surgery. In the GBP group, the investigators will measure the~     gastric pouch volume, the candy cane Roux limb volume, the neostomach volume (= gastric~     pouch+candy cane Roux limb) and the gastro-jejunal anastomosis diameter. In the SG group, the~     investigators will measure the volume of the gastric tube, of the non resectedantrum, of the~     whole residual stomach and the gastric tube diameter at the middle of the small curvature.~     Volume variations between 3 and 12 months will be compared to the EWL and to clinical and~     metabolic data (HbA1c, Insulinemia, HOMA index, liver steatosis). A 30% dilatation of the~     neostomach at 12 months will be considered as significant. Reinhold's criteria will be used~     to define surgical failure: EWL<50% at 12 months. Weight regain will be considered as~     significant if the weight reached at 12 months is higher than the minimum weight obtained.~     Gastric volume variation, EWL and BMI evolution between the 3rd and the 12th month will be~     analysed in the whole population and in each group (GBP and SG) with a Wilcoxon test.~      Expected benefits If the investigators valid the hypothesis that the dilatation of the~     neostomach is an essential factor in weight regain after GBP and SG, the benefit for the~     patient will be dual: 1/ validate the prognostic value of gastric volumetry by gastric~     tomodensitometry with gas in order to explain weight regain, and in order to use it as a~     standard. 2/ the identification of specific risk factors related to the surgical procedure~     could result in surgical technique improvements as well as a better adaptation of revisional~     procedures, in order to improve treatment of recurrent obesity.~   "
122532|NCT01963624|"~     The investigators hypothesis is that the combined use of elastography and color doppler~     ultrasonography can increase positive-predictive value of breast screening with ultrasound.~   "
122533|NCT01963611|"~     This is a Phase 2, randomized, rater-blinded, 5-arm, parallel-group trial that will test 4~     doses of plovamer acetate against the active comparator Copaxone in subjects with Relapsing~     Remitting Multiple Sclerosis (RRMS). The trial will be conducted on an outpatient basis for~     minimum treatment duration of 40 weeks.~   "
122534|NCT01963598|"~     This is a randomized, double-blind, placebo-controlled, multicenter phase 2 study of the~     safety and efficacy of 3-month subcutaneous (SC) REGN1033 (SAR391786) treatment in patients~     with sarcopenia.~   "
122535|NCT01963585|"~     Background:~      Bronchial hyper responsiveness (BHR) assessed by methacholine challenge test (MCT) may aid in~     the diagnosis of asthma, while negative MCT can help to exclude the diagnosis. Laboratory~     measures that predict the results of MCT are expected to reduce the number of procedures. The~     possible capacity of High sensitive C-reactive protein (hs-CRP), a marker of systemic~     inflammation, to predict negative or positive MCT in children has not been evaluated.~      Aim: to evaluate the capacity of hs-CRP to predict positive or negative MCT in school aged~     children and to compare it with markers of airway inflammation: Fractional exhaled Nitric~     Oxide (FeNO) and markers of allergic sensitization (IgE and peripheral blood eosinophils).~      Design: Prospective study evaluating these parameters in patients with positive and negative~     MCT.~      Participant selection: The study population included subjects (age range 6 to 18 years)~     referred for Methacholine Challenge Test (MCT)~      Sample size: 130 participants in the two groups. Intervention: Each subject will undergo~     evaluation including a respiratory questionnaire, methacholine challenge test with~     determination of PC20(the provocative concentration that reduced FEV1 by 20% from baseline),~     exhaled nitric oxide (eNO). Venous blood will be analyzed for complete blood count +~     eosinophils, IGE levels, hs-CRP. All measurements will be evaluated in a single 3 hour visit,~     with no follow up study visits.~      Primary end point: hs-CRP levels as add on tool to predict negative or positive MCT in~     children Secondary outcome parameters: All other parameters are the secondary end points.~   "
122536|NCT01963572|"~     Background and Purposes: Cancer is the leading cause of our mortality. It threatens people's~     life and quality of life (QOL). Although the incidence of cancer is still rising, with the~     promotion of cancer screening and progression of medical technology, its survival rate is~     improving. However, the sequels from cancer or its treatment and the side effects impact the~     patients along with their lives. Breast cancer is the most incident cancer in women with high~     survival rate, continuing care after the diagnosis and treatment is much more needed. This~     study is using breast cancer as an example to establish a continuing service model. This~     study aims (1) to establish a tailored, continuing care model which emphasizes on breast~     cancer patients' function. (2) To investigate the effectiveness of the new care model~     comparing with the control. (3) To find a cutting point of bioelectrical impedance to~     identify late development of lymphedema.~      Methods: This is a randomized-controlled trial expanding for 3 years. Women being newly~     diagnosed with breast cancer and first OPD visit after operation at National Taiwan~     University Hospital will be invited to join the surveillance and care system. Exclusion~     criteria are: younger than 20 years old, stage IV, recurrent or both sides involved, with~     other cancer diagnosis, functional impairments from previous injury or operation on the~     affected upper extremity and other physical or mental problem to influence the test or~     filling the questionnaire. It is estimated there will be 100 subjects participate this study~     every year. After the initial evaluation, they will be randomly allocated to surveillance~     group (SG) or general care group (CG). Totally, in this three-year study, there will be 200~     subjects (100/group), follow-up for 0.5 to 2 years. SG will have health education brochure~     and free class from the first visit post-operatively but CG will only have the brochure.~     Moreover, SG will be screened every time when they visit the clinics. If there is any early~     sign of impairment, professional advice and counseling will be given additionally. In these~     visits, if CG raises any health-related question, they can be answered. Detailed physical~     examination to identify their impairments and QOL are at 3, 6, 12, 18, 24 months after~     operation for both groups. Patients' characteristics, functional status, QOL will be~     presented by descriptive statistics. T-test/Mann-Whitney U test will be used to compare the~     differences between patients in two groups. Survival analysis and log-rank test will be used~     to show the prevalence of various functional impairments and test their difference. ROC curve~     will be used to find the cutting point for prediction of lymphedema.~      Expected Results: It is expected (1) to set up the education program and brochure for breast~     cancer patients. (2) to establish a continuing surveillance and care model for breast cancer~     patients and extending to all cancers. (3) Women in the new care model will have less~     impairment and higher QOL comparing with women at the same post-operative stage. (4) To find~     out the prevalence of functional impairments from the data of control group. (5) A cutting~     point of bioelectrical impedance to identify late development of lymphedema will be found.~     (6) To train the team members of cancer care and research.~   "
122537|NCT01963559|"~     15% of diabetics have a diabetic foot (DF) in their lives associated with a risk of~     amputation and mortality two times greater than that of a diabetic population without DF.~     Predicting the occurrence of an DF is limited and only the occurrence of a diabetic wound up~     involved assessment and treatment. Our team is behind the discovery of the Pressure-Induced~     Vasodilation (PIV) first observed in healthy subjects after local application of a gradual~     pressure on the skin leading to cutaneous vasodilation at the application of pressure. This~     gain in blood flow delays the onset of ischemia. However the involvement of PIV in the DF,~     which is also a pressure-induced skin lesion, remains to be demonstrated in diabetic~     subjects. The main objective of this study is to show that PIV, a functional examination of~     the cutaneous microcirculation we developed, is altered in the presence of DF, taking into~     account the influence of age and neuropathy.~   "
122538|NCT01963546|"~     General anesthesia can be considered as a combination of hypnosis, antinociception and~     immobility. Explore the effect of three kinds of anesthesia,that is the total intravenous~     anesthesia, inhalation anesthesia and inhalation and intravenous anesthesia on stress~     reactions generated by patients with diabetes conducted gastric - bypass surgery , and choose~     a best way from three kinds of anesthesia to control stress reaction of diabetics. After~     selecting the appropriate anesthesia method, assess the effect of dexmedetomidine on~     controlling stress response from diabetics undergoing laparoscopic gastric-bypass surgical.~   "
122539|NCT01963533|"~     The investigators hypothesize that the age-adjusted telomere length in lung cancer patients~     before chemotherapy may be correlated to comorbidity status and predict outcome. The change~     of telomere length shortening after chemotherapy may relate to treatment side effect and~     treatment response.~   "
122540|NCT01963520|"~     Data from large prospective cohort studies of prosthetic joint infections are lacking.~      Aim of this study: analyzing prospectively the incidence of reinfection in patients with~     prosthetic hip infections who underwent surgery and received antibiotic therapy.~      Hypothesis: to confirm in a large group that the incidence of reinfection after excision~     -synovectomy in acute prosthesis hip infection is 30% and 15% for chronic infection after~     exchange arthroplasty (one or two stage exchange).~   "
122541|NCT01963507|"~     The study aimed to evaluate the chronic effects of resistance training on blood pressure and~     biochemical exams in hypertensive elderlies and the influence of the polymorphism of the~     angiotensin converting enzyme in these response.~   "
122543|NCT01963481|"~     This phase II trial studies how well exemestane and cyclophosphamide work in treating~     patients with estrogen receptor (ER) -positive, progesterone receptor (PR) -positive, and~     human epidermal growth factor receptor (HER)2-negative stage IV breast cancer.~   "
122549|NCT01963403|"~     This double-blinded, placebo-controlled, randomized trial will compare the effects of the use~     of a combined oral contraceptive pill to a placebo pill for women who are experiencing~     irregular and/or heavy bleeding associated with the use of an etonogestrel (ETG) implant.~      The hypothesis of the study is:~        -  Use of combined oral contraceptive will significantly improve bleeding patterns for~          users of ETG implant~        -  Continuation rate of ETG implant users will be increased by use of combined oral~          contraceptive in women desiring ETG implant removal because of the undesirable bleeding~        -  Adverse events will be uncommon and acceptable to women who use a combined oral~          contraceptive with the ETG implant~   "
122550|NCT01963390|"~     One promising but understudied area in the field of testosterone (T) therapy is its effect on~     metabolism and the development of type II diabetes. Metabolomics is a powerful research tool~     that can detect very early signs of metabolic derangement that may lead to metabolic disease.~     In this observational study, investigators aim to apply metabolomics in order to better~     understand how T therapy influences metabolism. In a clinical population of outpatient men~     with T deficiency investigators will perform comprehensive clinical evaluations and also~     obtain blood for metabolomics. This will be done once prior to T therapy and again after 4-6~     months of T therapy. Investigators hypothesize that they can detect metabolic derangements in~     men with T deficiency and that these derangements will improve with T therapy.~   "
122551|NCT01963377|"~     Feasibility of using an extra bronchoscopic channel for supplementation of oxygen will be~     studied by comparing O2-supplementation by nasal cannulae versus O2-supplementation through~     aspiration channel of the bronchoscope.~   "
122552|NCT01963364|"~     Some carbohydrates (complex sugars) which are found in grains, fruit and vegetables, cannot~     be digested by humans. When eaten they pass through the small bowel to the large bowel, or~     colon. Some bacteria that live in the colon are able to digest these carbohydrates, and use~     them as an energy source. This releases energy that humans can absorb, and may have other~     effects on health as well. The process also releases gases such as hydrogen and methane into~     the colon, which will eventually be released as flatulence.~      There is some evidence in animals, and humans, that changing the carbohydrate content of the~     diet may increase the numbers of bacteria in the colon that can use this energy source.~     Recent work has looked at how changes in colon bacteria and carbohydrate in the diet affect~     transit, the speed at which food and stool moves through the stomach and bowels. This~     undergraduate project will use techniques in Magnetic Resonance Imaging developed in~     Nottingham to investigate how a prolonged change in dietary carbohydrate might affect speed~     of transit through the bowel and gas production in the colon, and whether there is any~     evidence of a change in the level of signalling chemicals that may affect bowel function.~   "
122553|NCT01963351|"~     This observational trial is designed to assess the safety profile and tolerability of~     bevacizumab when combined with chemotherapy as first-line treatment of advanced or recurrent~     non-squamous NSCLC.~   "
122554|NCT01963338|"~     The aim of this study was to assess the acceptability and usability of a newly developed~     intradermal device in healthy adults~   "
122555|NCT01963325|"~     This phase II study was designed to evaluate the efficacy and safety of S-1 plus Abraxane as~     second-line treatment for cholangiocarcinoma.~   "
122556|NCT01963312|"~     The purpose of this study is to determine whether the transarterial supraselective~     embolization (TSE) is a technique as effective as transurethral resection of the prostate~     (TURP) for the treatment of lower urinary tract symptoms associated with benign prostatic~     hyperplasia (BPH).~   "
122557|NCT01963299|"~     This is a study conducted in 60 patients, randomly assigned to one of two groups of 30: the~     first will receive ropivacaine alone and the second will receive the association~     ropivacaine/clonidine.~      The aim of the study is to prove that the association of Clonidine with Ropivacaine is more~     effective than ropivacaine alone for locoregional anaesthesia of the eye for retinal surgery.~      The principal interest of this association of drugs is that it procures faster and longer~     anaesthesia of the eye with less ropivacaine (therefore fewer injections). This provides~     greater comfort to the patient during and after the intervention.~   "
122558|NCT01963286|"~     The purpose of this clinical investigation is the continued assessment of the decision~     accuracy of St. Jude Medical (SJM) ICD with enhanced SVT discriminators in the treatment of~     subjects with primary and secondary prevention of sudden cardiac death.~   "
122559|NCT01963273|"~     The investigators supposed that the complete video assisted ablation of pilonidal sinus~     (VAAPS) could be an effective minimally invasive treatment of pilonidal sinus. This new~     minimally invasive treatment allows the identification of the sinus cavity with its lateral~     tracks, the destruction and the removal of all infected tissue and the removing of any hair.~   "
122560|NCT01963260|"~     The primary objectives of this study are to assess the safety and tolerability of single~     rising doses of MK-8723 in healthy adult participants and adult participants with chronic~     immune thrombocytopenia purpura (ITP) and to assess pharmacodynamics of MK-8723 in~     participants with ITP. The primary hypothesis is that the true placebo-adjusted platelet~     response rate to MK-8723 in adult patients with chronic ITP is >50%.~   "
122561|NCT01963247|"~     Currently, there is no direct, reliable, bed-side, and non-invasive method for assessing~     changes in brain activity associated with concussion. Event Related Potentials (ERPs), which~     are temporal reflections of the neural mass electrical activity of cells in specific regions~     of the brain that occur in response to stimuli, may offer such a method, as they provide both~     a noninvasive and portable measure of brain function. The ERPs provide excellent temporal~     information, but spatial resolution for ERPs has traditionally been limited. However, by~     using high-density electroencephalograph (EEG) recording spatial resolution for ERPs is~     improved significantly. The paradigm for the current study will combine neurophysiological~     knowledge with mathematical signal processing and pattern recognition methods (BNA™) to~     temporally and spatially map brain function, connectivity and synchronization.~      The proposed study will provide additional evidence for the utility and contribution of the~     BNA™ test (reflecting temporal and spatial changes in brain activity as well as brain~     functional connectivity associated with concussion) in concussion management.~      The BNA test is basically divided to 3 phases - first EEG data is collected from subjects~     using an EEG system while the subject is performing a cognitive task in front of a computer.~     The EEG data is then analyzed using the advanced BNA™ technology. Finally, a report of the~     BNA™ test is generated.~   "
122563|NCT01963221|"~     The purpose of this study is to determine the relationship between thoracic aortic~     inflammation and arterial stiffness in elderly patients.~      Vascular-aging is accompanied by a gradual remodeling affecting both cardiac and arterial~     walls. Arterial hypertension, an established cardiovascular risk factor, has been suggested~     to exert pro-inflammatory actions threw several biological mediators enhancing arterial~     stiffness. Both effects of aging and hypertension are associated with higher levels of~     arterial stiffness, but their respective role is not well established in the pathophysiology~     of arterial stiffening.~      Few data are available neither on the real anatomic aortic impact of aging and hypertension~     on aortic compliance and ventricular function and its relationship to arterial stiffness~     assessed by carotid-femoral pulse wave velocity, nor on the reliability of cine phase~     contrast magnetic resonance imaging arterial stiffness measurements.~      Recent studies using positron emission tomography imaging (PET) with 18 F fluorodeoxyglucose~     (FDG) has been advocated as a means of measuring arterial wall inflammation in various~     population referred for oncology staging. FDG uptake is correlated with the number of~     cardiovascular risk factors and even the risk of future cardiovascular events. This method,~     combined with X-ray computed tomography (CT), has also demonstrated that aortic~     calcifications quantified by CT and local signs of inflammation detected by FDG uptake~     contribute to arterial stiffness. A strong relationship between large vessels stiffening~     assessed by carotid-femoral pulse wave velocity measurement, aortic calcifications quantified~     by CT and inflammation evaluated by FDG uptake has been demonstrated.~      Therefore, in the current study, we use FDG PET associated to CT to characterize aortic~     inflammation and aortic calcifications coupled to pulse wave velocity measurement and cardiac~     function in elderly individuals.~      In fact, if vascular aging promoting a local inflammatory process is a risk factor for~     cardiovascular disease, then vascular changes assessed by non-invasive vascular imaging~     (MRI,FDG PET) could represent a potential target for treatment and prevention Thirty~     individuals ≥ 65 years of age were examined, 15 hypertensive subjects and 15 controls. Pulse~     wave velocity, a surrogate for aortic stiffness, was measured both by cine phase contrast~     magnetic resonance imaging and applanation tonometry. Brachial pulse pressure, carotid~     calculated pulse pressure and pulse pressure amplification (brachial to carotid ratio),~     predictors of cardiovascular mortality were also quantified. Thoracic aorta local~     inflammation and calcification were measured by 18 F-fluorodeoxyglucose positron emission~     tomography/computed tomography imaging. Moreover, biomarkers of low grade inflammation~     (high-sensitivity C-reactive protein, interleukin 6 were also determined).~   "
122564|NCT01963208|"~     The study will evaluate the effectiveness and safety of an investigational drug-ganaxolone -~     on partial seizure frequency in adults with epilepsy taking a maximum of 3 antiepileptic~     medications (AEDs).~   "
122565|NCT01963195|"~     The purpose of this study is to evaluate the efficacy and safety of dose escalation of~     Icotinib in advanced non small cell lung cancer (NSCLC) patients after the therapy of~     Icotinib, Iressa and Tarceva.~   "
122566|NCT01963182|"~     This prospective, non randomized multicenter phase II study, will determine the feasibility~     of individualized dose of irinotecan with the UGT1A1 polymorphism, in patients with~     metastatic colorectal cancer treated with FOLFIRI.~   "
122567|NCT01963169|"~     Bone health is a significant public health issue in the United States. An estimated 10~     million Americans age 50 and older are living with osteoporosis, and approximately 50% of~     women and 25% of men over age 50 will experience an osteoporosis-related fracture in their~     remaining lifetime. Recent research advancements have produced effective measures to improve~     and maintain bone health, including exercise, diet, screening tests, pharmacotherapies, and~     fall prevention strategies. These findings, however, have not been fully incorporated into~     the daily lives of adults, and many are unaware of the magnitude of bone-health problems.~     Thus, greater efforts must be made to effectively disseminate evidence-based research~     findings to improve bone health behaviors of the public. The Internet, with its increasing~     popularity, can be an effective tool in this endeavor. Despite a great deal of available~     online health resources, there has been a lack of research investigating effective methods to~     package and deliver these resources to yield positive public health outcomes. Expanding upon~     our prior findings and using an innovative approach combining two models of the social~     cognitive theory (SCT) and the RE-AIM framework (Reach, Effectiveness, Adoption,~     Implementation, Maintenance), in this proposal, we propose a large scale online study (N =~     866) that will compare the long-term impact of two SCT-based online bone health interventions~     in adults age 50 and older targeting two large online communities. The two interventions are~     (1) an 8-week SCT-based Online Bone Health (TO-BoneHealth) program and (2) a 12-month~     TO-BoneHealth Plus program, including the TO-BoneHealth program followed by biweekly~     theory-based eNewsletters with follow-up of each individual's bone health behaviors~     (booster intervention) for 10 months. The interventions' impact will be assessed on the~     following the modified RE-AIM framework: (a) Effectiveness (knowledge, selected bone health~     behaviors, fall incidence, initiation of a discussion about bone health with a primary care~     provider, eHealth literacy); (b) Reach (number of participants the program reached); (c)~     Implementation (program usage); and (d) Maintenance (participants' bone health behavior~     maintenance). With the rapid growth of online communities, findings from this study will~     significantly contribute to current eHealth practice and research and serve as a~     dissemination model for other health promotion projects targeting online communities.~   "
122568|NCT01963156|"~     The aim of this study is to evaluate if synchronizing when patients with diabetes and/or~     coronary artery disease fill their prescriptions improves long-term adherence to these~     medications.~   "
122569|NCT01963143|"~     The primary objective is to demonstrate the bioequivalence of Gammaplex® 10 intravenous~     immunoglobulin (IGIV) and Gammaplex® 5% IGIV with respect to area under the curve within a~     28-day dosing interval (AUC0-28) in a cohort of adult subjects.~      The secondary objectives are to demonstrate the bioequivalence of Gammaplex® 10 IGIV and~     Gammaplex® 5% IGIV with respect to area under the curve within a 21-day dosing interval~     (AUC0-21) in adult subjects; to assess the pharmacokinetics of Gammaplex 10 IGIV and~     Gammaplex 5% IGIV including Immunoglobulin G (IgG) trough levels and to investigate the~     safety and tolerability of Gammaplex 10 IGIV and Gammaplex 5% IGIV in adults subjects; to~     assess the pharmacokinetics of Gammaplex 10 IGIV including IgG trough levels and to~     investigate the safety and tolerability of Gammaplex 10 IGIV in pediatric subjects.~   "
122570|NCT01963130|"~     This study investigated how vildagliptin (a di-peptidyl peptidase 4 inhibitor) affects portal~     vein pressure and hepatosteatosis in patients with type 2 diabetes mellitus.~   "
122571|NCT01963117|"~     The standard treatment of unresectable liver metastasis in gastrointestinal tract cancer is~     chemotherapy, but considerable portion of the patients progressed and most of the liver is~     converted to metastatic tumor lesions. Significant quality of life decrement was detected in~     those patients, especially in patients suffered severe symptoms Several studies reported that~     whole liver RT (WLRT) can be used effectively to control severe symptoms from unresectable~     liver metastasis in gastrointestinal tract cancer patients. However, it is well known fact~     that the liver is a very sensitive to RT. Despite symptom palliation is obtained after 20 to~     30 Gy RT but only in small subset of patients get local control. In this aspect, the combined~     with radiosensitizer with WLRT is considered to enhance RT effect to palliate symptom and~     control local tumor progression, and increase the quality of life ultimately.~      It is reported that hyperthermia is considered as the most valuable radiosensitizer in cancer~     treatment, theoretically. Based on those studies, we start this prospective study to~     investigate the effect of combination treatment of WLRT and hyperthermia on quality of life~     in the patients with unresectable chemoresistant liver metastasis from gastrointestinal tract~     cancer.~   "
122572|NCT01963104|"~     The overall goal of the project is to evaluate innovative, cost-effective, community-based~     automated hearing screening and education methods to motivate individuals with~     mild-to-moderate hearing loss to enter the hearing healthcare system.~   "
122867|NCT01959256|"~     This study will test the hypothesis whether visual field defect caused by chronic stroke~     could be improved by visual perceptual learning. The secondary hypothesis is that improvement~     of visual field defect would be accompanied by connectivity changes in visual networks. In~     addition, investigators will evaluate whether improvement of visual field defect could~     achieve improvement of subjective visual function.~   "
122573|NCT01963091|"~     Stress is associated with drug craving and relapse in substance-dependent individuals.~     Hormones released from the brain may mediate the behavioral response to stress. For example,~     several studies have indicated that oxytocin reduces stress in laboratory stress paradigms.~     Specifically, it appears that oxytocin promotes trust, social interaction, and calmness; yet,~     little is known about the potential affects of oxytocin in cocaine-dependent individuals.~     Given these properties of oxytocin, it may have a therapeutic role in ameliorating the~     negative affect commonly observed prior to relapse in cocaine-dependent individuals, as well~     as the anxiety associated with withdrawal. This pilot protocol will provide important~     preliminary data on the effect of oxytocin on stress in cocaine-dependent individuals.~   "
122574|NCT01963078|"~     The purpose of the study is to use fMRI to investigate amygdala response to fearful faces in~     men and women with and without PTSD who have experienced childhood trauma. The study will~     also compare the effects of oxytocin and placebo on amygdala response, and explore the~     interaction of oxytocin plasma levels and amygdala response in men and women with and without~     PTSD who have experienced childhood trauma.~      Hypothesis 1: Amygdala responding will be greater in subjects with PTSD as compared to~     resilient subjects, and no sex differences in the magnitude of the response will be found.~      Hypothesis 2A: In response to OT, women will exhibit a greater reduction in amygdala~     responding than men.~      Hypothesis 2B: In response to OT, women with PTSD will exhibit a greater reduction in~     amygdala responding compared to women without PTSD.~      Hypothesis 3A: Women with PTSD will have lower levels of plasma OT as compared to men with~     PTSD, and women and men without PTSD.~      Hypothesis 3B: Plasma OT levels will be inversely correlated with amygdala responding to~     fearful faces in women but not in men.~   "
122575|NCT01963065|"~     The purpose of this study is to evaluate whether babies are exposed to significant levels of~     chemicals during their stay in the neonatal intensive care unit (NICU). For example, other~     research studies have shown that babies are exposed to plasticizers (bisphenol A, phthalates)~     in the NICU. Plasticizers are chemicals that are used to make plastic medical equipment soft~     and flexible. The research team wants to find out whether the amount of plasticizer and other~     chemicals babies may be exposed to in the NICU makes a difference in how they grow and how~     they perform on neurologic tests.~   "
122576|NCT01963052|"~     The objectives of this study are to assess the safety, pharmacokinetics, immunogenicity and~     anti-tumor activity of AGS15E in subjects with metastatic urothelial cancer who failed at~     least one prior chemotherapy regimen for metastatic disease.~   "
122577|NCT01963039|"~     Background The standard care in patients with a painful osteoporotic vertebral compression~     fracture (VCF) is conservative therapy. Percutaneous vertebroplasty (PV), a minimally~     invasive technique, is a relatively new treatment option. Recent randomized controlled trials~     (RCT) provide conflicting results: two sham-controlled studies showed no benefit of PV while~     an unmasked but controlled RCT (VERTOS II) found effective pain relief at acceptable costs in~     patients with acute VCFs. A still ongoing masked RCT (VERTOS IV) focuses on acute VCFs~     defined as ≤ 6 weeks. VERTOS III focused on conservative treatment and found that half of~     patients still had disabling pain after 3 months or longer. These patients with sustained~     pain after 3 months may benefit from PV.~      Objective To compare pain relief after PV with a sham intervention in selected patients with~     a chronic osteoporotic VCF ( three months or longer) using the same strict inclusion criteria~     as in VERTOS II an IV. Secondary outcome measures are back pain related disability and~     quality of life.~      Methods The VERTOS V study is a prospective RCT with pain relief as primary endpoint.~     Inclusion criteria are a VCF of thoracic level 5 or lower with focal tenderness at fracture~     level, assessed by an internist on physical examination and a Visual Analogue Scale (VAS)~     score ≥ 5 for three months or longer, decreased bone density defined as T score ≤ -1 and age~     50 years or older. 94 patients will be included, 47 in each arm. Crossovers are not allowed.~     Follow-up is at regular intervals during one year period with VAS score for pain as primary~     endpoint. Secondary endpoints are back pain related disability and quality of life measured~     with the Quality of Life Questionnaire of the European Foundation for Osteoporosis and~     physical function measured with the Roland Morris Disability questionnaire.~      Conclusion Vertos V is a methodologically sound masked randomised sham controlled trial of~     vertebroplasty in patients with sustained pain 3 months or longer after a vertebral~     compression fracture.~   "
122578|NCT01963026|"~     Introduction In recent years, client-centred and task-oriented training have emerged as~     important methods in rehabilitation including the rehabilitation of persons with spinal cord~     injury (SCI). The task-oriented intervention focuses on resolving, reducing and preventing~     impairment, developing effective task-specific strategies and adapting functional~     goal-oriented strategies to changing environmental conditions. Currently, task-specific~     training is mainly achieved by constant practice (i.e. repeating the task without variation)~     and is reported to improve performance of the trained task, but to have a negative impact on~     untrained tasks. Practice variability, however, is reported being advantageous to transfer~     training results into daily live. This paradox poses challenges in clinical practice, where~     task-specific training is essential to deliver client-centred training in order to focus on~     the patients' specific individual goals, but practice variability is important to be able to~     transfer the learned task into daily practice. Questions regarding the effective elements~     within rehabilitative interventions and the exact mechanisms behind the cerebral changes they~     may induce, remain. These questions require further research, for which ultra-high field fMRI~     techniques will be used. Furthermore, compensation of muscle function loss (i.e. the~     development of new muscle synergies) plays an important role in the improvement of skill~     performance in cervical SCI. Surface EMG allows to study the changes in muscle coordination,~     parallel to the changes at cerebral level.~      Aims This study aims to~        1. investigate which basic neural mechanisms of motor learning underlie functional recovery~          of arm hand skilled performance during client-centred task-oriented training of the~          upper limb in patients with cervical spinal cord injury and~        2. investigate the contribution of 'practice variability' in contrast to 'constant~          practice' on arm-hand skilled performance, motor control and neural changes.~      Study design This study features a multiple single-case experimental design (A-B-C design)~     with baseline (phase A) (6 weeks), intervention B (phase B) (3 weeks) and intervention C~     (phase C) (3 weeks). Intervention B will contain the 'practice variability' component.~     Intervention C will feature the 'constant practice' component. The order of phase B and C~     will be randomly assigned to participants. Four measurements during baseline and after each~     intervention phase (B and C) will be performed, thus producing a time series, per measure,~     for each patient. Also, meta-analyses on the pooled single-case data will be performed.~      Setting/population Six patients with a cervical SCI (complete and incomplete) will be~     recruited from the Spinal cord unit of Adelante Rehabilitation Centre in the (sub)acute~     phase.~      Intervention After therapy as usual (intervention A), the Task-oriented Client-centred Upper~     Extremity Skill Training (ToCUEST) module (Spooren et al., 2011) will be provided. In this~     program individual goals will be extracted using the Canadian Occupational Performance~     Measure(COPM) and the training program is based on a task-analysis and uses principles of~     training physiology and motor learning. Intervention B will consist of the ToCUEST program,~     including the component 'practice variability' (ToCUEST variability). Intervention C will~     consist of a modified ToCUEST program in which the component 'practice variability' will be~     replaced by 'constant practice' (ToCUEST constant) in order to evaluate the contribution of~     these components. Intervention A' will be therapy as usual.~      Measurements Measurements will be taken at the level of activities (arm hand skilled~     performance, i.e. Van Lieshout Test, Spinal Cord Independence Measure, Goal Attainment Scale)~     and body function (Upper Extremity Motor Score, Graded Redefined Assessment of Strength~     Sensibility and Prehension Test, Surface EMG), and at cerebral level, i.e. neural activity~     changes (by means of ultra-high field fMRI).~      The fMRI measurements will be taken before and after each intervention B and C in 4 patients~     (2 with complete and 2 with incomplete lesion).~      Data-analyses Baseline data stability and any baseline trends regarding the outcome measures~     at body function level and activity level will be assessed. To control for, e.g., spontaneous~     recovery effects, baseline data (phase A) will be used in a computer-based detrending model.~     For the meta-analyses, mean data per outcome measure, per phase, per subject will be pooled~     and subsequently analysed using non-parametric statistics, i.e. Friedman analyses and~     Wilcoxon tests.~   "
122579|NCT01963013|"~     This study was to determine efficacy of the non-returning catheter valve for reducing~     catheter associated urinary tract infection compared with conventional urine bag in~     critically ill patients.~   "
122580|NCT01963000|"~     Community acquired pneumonia (CAP) is associated with a high in-hospital mortality.~     Standardization of diagnostics and adherence to sepsis bundles in the emergency department~     (ED) are associated with reduced mortality in patients with sepsis. Investigators examined~     whether the introduction of standardized care bundles and check lists in the ED are~     associated with a reduced mortality rate in patients hospitalized for CAP.~      This is an observational trial. The investigators retrospectively analyzed performance~     indicators of 2819 consecutive patients with CAP admitted to the Nuremberg Hospital, Germany,~     from 2008 to 2009. At the turn of the year, implementation of CAP care bundles took place~     including interprofessional education, checklists and institutionalized feedback. Primary~     endpoint was in-hospital mortality of CAP patients. After the implementation of CAP care~     bundles in the ED, mortality of affected patients was significantly lower in 2009 compared to~     2008. This study should demonstrate that the implementation of a standardized CAP care bundle~     in the ED is associated with a risk reduction in affected patients. Standardization of~     diagnostic and therapeutic processes in the ED therefore improves the outcome of patients~     hospitalized for CAP.~   "
122581|NCT01962987|"~     To compare the relative efficacy and safety of the test formulation diclofenac sodium gel 3%~     (Actavis) to the marketed formulation Solaraze® (diclofenac sodium) Gel 3% (Fougera Pharms)~     in the treatment of the actinic keratosis~   "
122582|NCT01962974|"~     This is a Phase 3b, multicenter study of the efficacy of golimumab 2 mg/kg IV in subjects~     with active rheumatoid arthritis who are receiving methotrexate and have inadequate disease~     control (defined as an erythrocyte sedimentation rate [ESR]-based Disease Activity Score in~     28 joints [DAS28] ≥ 3.2 and ≥ 4 swollen and ≥ 4 tender joints) despite current anti-TNFα~     therapy with infliximab 2 - 4 mg/kg every 4 weeks, 2 - 5 mg/kg every 5 weeks, 3 - 6 mg/kg~     every 6 weeks, 3 - 7mg/kg every 7 weeks, or 4 - 8 mg/kg every 8 weeks.~      To be eligible for participation, subjects must have previously demonstrated initial and/or~     temporary improvement in disease signs and symptoms, who have since exhibited a diminished~     response despite continued treatment. It is estimated that 200 subjects will be enrolled in~     the study at approximately 85 global sites.~   "
122583|NCT01962961|"~     The goal of this study is to determine if n-acetylcysteine, given as PharmaNAC, reduces~     oxidative stress and improves vascular function in HIV-infected older adults already on HIV~     treatment.~   "
122584|NCT01962948|"~     This phase I/II trial studies the side effects and best dose of ganetespib when given~     together with paclitaxel and to see how well they work in treating patients with recurrent~     ovarian, fallopian tube, or primary peritoneal cancer. Drugs used in chemotherapy, such as~     paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Ganetespib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Giving paclitaxel and ganetespib may be~     an effective treatment for ovarian, fallopian tube, or primary peritoneal cancer.~   "
122585|NCT01962935|"~     Study to investigate safety, tolerability and effect of multiple dosing with AZD 4721 and/or~     with AZD 5069~   "
122586|NCT01962922|"~     Open label, prospective, single-center, randomized, two sequence, three period crossover~     study to compare the steady state pharmacokinetics of LCP-Tacro tables to generic tacrolimus~     capsules administered twice daily in stable African-American renal transplant patients.~   "
122587|NCT01962909|"~     The purpose of this clinical trial is to study an experimental drug called PTP-01 that is~     being used as an imaging agent to diagnosis pancreatic cancer. Currently, pancreatic cancer~     is diagnosed using CT or MRI scans which miss small pancreatic cancers, particularly early~     stage disease. Researchers at the University of Virginia have identified a biomarker for~     pancreatic cancer called plectin, which is very specific for pancreatic cancer and not other,~     non-cancerous conditions involving the pancreas. These researchers have also developed~     PTP-01, an experimental drug that may be used with SPECT imaging to detect pancreatic cancer~     cells in humans.~   "
122588|NCT01962896|"~     The purpose of this study is to find out if the combination of an mTOR inhibitor (sirolimus)~     with an EGFR inhibitor (erlotinib) is effective at treating relapsed or refractory germ cell~     tumors, and to find out what the side-effects of this regimen are.~   "
122589|NCT01962883|"~     The proposed study is a randomized clinical trial with the purpose of determining the~     efficacy of osteopathic treatment on vestibular symptoms of the post concussed vestibular~     disturbed athlete as determined by the Dizziness Handicap Inventory (DHI) and the Balance~     Error Scoring System (BESS). Of secondary interest, this study will evaluate the osteopathic~     assessment findings of this population and side effects, positive and negative, associated~     with the osteopathic treatment provided.~      Primary Hypothesis~        1. Osteopathic treatment will have no effect on the symptoms of dizziness of the vestibular~          disturbed post concussed athlete using the Dizziness Handicap Inventory~        2. Osteopathic treatment will have no effect on the balance recovery of the vestibular~          disturbed post concussed athlete using Balance Error Scoring System (BESS)~           Secondary Hypothesis~        3. To determine the side effects of osteopathic treatment of the vestibular disturbed post~          concussed athlete~   "
122590|NCT01962870|"~     Researchers at the Stanford University School of Medicine are seeking participants for a~     study examining the effectiveness of vasopressin, a neuropeptide, in treating children with~     autism spectrum disorder. Difficulty with social interactions is characteristic of people~     with autism, who often have problems interpreting facial expressions or maintaining eye~     contact while talking with someone. There are currently no effective medicines available to~     treat social problems in individuals with autism. Neuropeptides, such as vasopressin and~     oxytocin, are molecules used by neurons in the brain to communicate with one another.~     Vasopressin is closely related to oxytocin, which is currently being tested as a treatment~     for autism, and has been shown to enhance social functioning in animals. Animal studies have~     shown that when the proper functioning of vasopressin is experimentally altered, animals~     develop a variety of social deficits, including impaired memory for peers and a reduced~     interest in social interaction. Researchers found that when vasopressin was administered to~     mice with a genetically induced form of autism, their social functioning improved.~     Vasopressin is already approved by the Food and Drug Administration for use in humans, and~     has proved to be a successful treatment for some common pediatric conditions, including~     bedwetting. Similar to oxytocin, it also has been shown to improve social cognition and~     memory in people who do not have autism. The researchers will test the effects of vasopressin~     on social impairments in 50 boys and girls with autism, ages 6 to 12 years old. The study~     will last four weeks for each participant. Participants will receive either vasopressin or a~     placebo nasal spray. At the end of this phase of the study, those who received the placebo~     will have the option of participating in a four-week trial during which they will be given~     vasopressin. Stanford is the only site for the study. Participants do not need to live~     locally but will need to come to the Stanford University Department of Psychiatry and~     Behavioral Sciences for study visits.~   "
122591|NCT01962857|"~     A number of studies have shown that short duration, high intensity interval training can~     improve health-related outcomes, such as insulin sensitivity and cardiorespiratory fitness.~     However, these often use specialized equipment, such as cycle ergometers, which makes it~     difficult to roll these interventions out for wide-scale use in the general population. This~     study aims evaluate the effects of a high intensity shuttle running intervention on insulin~     sensitivity, fitness and related cardiometabolic risk factors in men who are currently~     inactive. Participants will be randomized into intervention (4 weeks of shuttle running) and~     control groups. We hypothesize that the shuttle running programme will result in improved~     insulin sensitivity, fitness and increased fat oxidation at rest compared with the control~     group.~   "
122592|NCT01962844|"~     The purpose of this study is to evaluate the supplementation with extra virgin of coconut oil~     combined with a nutritional counseling in reducing anthropometry and improves the lipid~     profile in patients with chronic coronary disease.~   "
122593|NCT01962831|"~     The purpose of this study is to compare the efficacy of single balloon foley catheters to~     dinoprostone for the induction of labour of obese women. The investigators suspect that women~     assigned to the foley group will have a shorter induction to delivery time than women in the~     dinoprostone group.~   "
122594|NCT01962818|"~     Background Ventilator induced lung injury (VILI) remains a problem in neonatology. High~     frequency oscillatory ventilation (HFOV) provides effective gas exchange with minimal~     pressure fluctuation around a continuous distending pressure and therefore small tidal~     volume. Animal studies showed that recruitment and maintenance of functional residual~     capacity (FRC) during HFOV (open lung concept) could reduce lung injury.~      Open lung HFOV is achieved by delivering a moderate high mean airway pressure (MAP) using~     oxygenation as a guide of lung recruitment. Some neonatologists suggest combining HFOV with~     recurrent sigh-breaths (HFOV-sigh) delivered as modified conventional ventilator-breaths at a~     rate of 3/min. The clinical observation is that HFOV-sigh leads to more stable oxygenation,~     quicker weaning and shorter ventilation. This may be related to improved lung recruitment.~      Electric Impedance Tomography (EIT) enables measurement and mapping of regional ventilation~     distribution and end-expiratory lung volume (EELV). EIT generates cross-sectional images of~     the subject based on measurement of surface electrical potentials resulting from an~     excitation with small electrical currents and has been shown to be a valid and safe tool in~     neonates.~      Purpose, aims:~        -  To compare HFOV-sigh with HFOV-only and determine if there is a difference in global and~          regional EELV (primary endpoints) and spatial distribution of ventilation measured by~          EIT~        -  To provide information on feasibility and treatment effect of HFOV-sigh to assist~          planning larger studies. We hypothesize that EELV during HFOV-sigh is higher, and that~          regional ventilation distribution is more homogenous.~      Methods:~      Infants at 24-36 weeks corrected gestational age already on HFOV are eligible. Patients will~     be randomly assigned to HFOV-sigh (3 breaths/min) followed by HFOV-only or vice versa for 4~     alternating 1-hours periods (2-treatment, double crossover design, each patient being its own~     control). During HFOV-sigh set-pressure will be reduced to keep MAP constant, otherwise HFOV~     will remain at pretrial settings.~      16 ECG-electrodes for EIT recording will be placed around the chest at study start. Each~     recording will last 180s, and will be done at baseline and at 30 and 50 minutes after each~     change in ventilator modus.~      Feasibility No information of EIT-measured EELV in babies on HFOV-sigh exists. This study is~     a pilot-trial.~      In a similar study-protocol of lung recruitment during HFOV-sigh using a/A-ratio as~     outcome, 16 patients was estimated to be sufficient to show an improvement by 25%. This~     assumption was based on clinical experience in a unit using HFOV-sigh routinely. As the~     present study examines the same intervention we assume that N=16 patients will be a~     sufficient sample size. We estimate to include this number in 6 months.~   "
122595|NCT01962805|"~     This study is a double-blind crossover study in female healthy volunteers to compare the~     pharmacokinetics and safety of either 1 or 6 days of dosing with two different formulations~     of Proellex for vaginal administration. Each formulation will be designated as either~     Treatment A or Treatment B. A total of 8 subjects who meet the eligibility criteria will be~     randomized to receive either Treatment A or Treatment B as their first assigned treatment.~     Subjects will receive a single dose of Treatment A or daily dosing with Treatment B for 6~     days. After a 7-day washout period subjects will receive the alternative treatment. On the~     day of treatment with Treatment A and on the first and last days of treatment with Treatment~     B subjects will remain in the clinic overnight and undergo 32-hour pharmacokinetic assessment~     at the following time points: 0, 0.5, 1, 2, 4, 8, 12, 16, 20, 24, 28 and 32 hours after~     administration of study drug. For Treatment B study drug will be administered in the clinic~     each day after a trough blood sample has been drawn.~   "
122868|NCT01959243|"~     To compare the safety and tolerability of brimonidine tartrate ophthalmic solution 0.025%~     versus its vehicle in a population of pediatric, adult, and geriatric subjects. At least 51%~     of subjects will be 40 years of age or older.~   "
122597|NCT01962779|"~     Our preliminary data show for in cognitively-normal elderly, that Sleep Disordered Breathing~     (SDB) is associated with the increase of cerebrospinal fluid (CSF) phosphorylated-Tau (P-Tau)~     and total-Tau (T-Tau), decreases in medial temporal lobe glucose uptake (FDG-PET) and volume~     (MRI) and progressive memory decline, all of which have been shown to be useful in predicting~     future dementia in older adults. These findings raise the question as to whether Alzheimer's~     disease (AD) tissue damage causes SDB in the elderly, or alternatively, if SDB acts as a risk~     factor for AD neurodegeneration. In the proposed study, we will investigate these mechanistic~     hypotheses in cognitively normal elderly by examining the longitudinal associations between~     SDB and cognitive decline, novel MR neuroimaging and CSF biomarkers for neurodegeneration;~     while our secondary goal is to launch a pilot treatment study to aid in interpreting the~     mechanistic hypotheses and to examine the effects of nasal continuous positive airway~     pressure (CPAP) on cognitive decline and neurodegeneration.~   "
122598|NCT01962766|"~     The current research project aims to study the efficacy of myofunctional therapy and its~     orthodontic long-term outcomes.~   "
122599|NCT01962753|"~     The primary objective of the study is to compare the brain amyloid load in fully, partially~     and non remitting depressed elderly patients at 8 weeks of antidepressant therapy, by using~     PET with [F18]AV45.~   "
122600|NCT01962740|"~     The study is proposed as a 48-patient randomized-controlled pilot study that will use Optical~     Coherence Tomography (OCT) imaging to compare stent strut coverage and malapposition of three~     second-generation Drug Eluting Stents (DES) [Xience EES (Abbott Vascular, Santa Clara, CA),~     Resolute Integrity ZES (Medtronic, Minneapolis, MN) and Promus Element EES (Boston~     Scientific, Natick, MA)] at 6 weeks post implantation.~      Study Hypothesis is that the rates of stent strut coverage and malapposition of the Xience~     EES, Promus EES and will be similar to each other and improved (higher rates of stent strut~     coverage and lower rates of malapposition) compared to the Resolute ZES at 6 weeks~     post-implantation.~   "
122601|NCT01962727|"~     Study Design: Clinical measurement (cross-sectional)~      Objectives: The purpose of this study was to investigate the reliability and validity of the~     novel scapular dyskinesis classification test.~      Background: A visual-based clinical assessment with sufficient reliability and validity to~     identify scapular dyskinesis provides information for rehabilitation treatment.~      Methods: A visual-based palpation method was evaluated by two independent physiotherapists in~     60 subjects with unilateral shoulder pain to test reliability. This method classified the~     scapular movements during arm raising/lowing movements in scapular plane as single abnormal~     scapular patterns (inferior angle/ medial border/ superior border of scapula prominence and~     abnormal scapulohumeral rhythm) or mixed abnormal scapular patterns. Different patterns of~     scapular dyskinesis were also validated by corresponding alternation of the scapular~     kinematics and muscular activities assessed by electromagnetic motion-capturing system and~     surface electromyography (EMG).~   "
122602|NCT01962714|"~     This randomized controlled trial will assess whether a novel complementary and alternative~     medicines (CAM) intervention, Loving-kindness Meditation (LKM), is not meaningfully inferior~     to another group-based PTSD treatment , Cognitive Processing Therapy (Cognitive Only version;~     CPT-C) for reductions in PTSD and depressive symptoms. 170 male and female Veterans with~     current PTSD will be randomized to LKM or CPT-C. The investigators hypothesize that Veterans~     randomized to LKM will report mean reductions in PTSD and depressive symptom severity that~     are not meaningfully worse than CPT-C. The investigators further hypothesize that reductions~     in posttraumatic maladaptive beliefs will more strongly mediate PTSD and depressive symptom~     improvement for those assigned to CPT-C than those assigned to LKM.~   "
122603|NCT01962701|"~     The relationship of uterine contractions on fetal copeptin levels in umbilical cord blood is~     studied.~   "
122604|NCT01962688|"~     The purpose of this study is to see if using a portable handheld ultrasound to guide diuretic~     therapy for heart failure patients will prevent hospital readmissions. This study will use a~     handheld ultrasound called a Vscan to look at a large vessel in the body called the Inferior~     Vena Cava (a vein leading to your heart) . The study aims to see whether changing diuretic~     therapy based on the size of this vessel will result in the less hospitalizations for heart~     failure patients as compared to just symptom guided therapy. This study is composed of two~     independent non-interacting trials—one in the outpatient setting and one in the inpatient~     setting.~   "
122605|NCT01962675|"~     The study investigates the effect of using transcranial direct current stimulation (tDCS) and~     skilled stepping training versus skilled stepping training with sham-tDCS in improving ankle~     and leg motor control in persons with ambulatory persons with spinal cord injury.~      Hypotheses H1: Participants will display greater improvement in stepping function following~     tDCS combined with training compared to sham-tDCS and training.~      H2: Participants will display greater gains in cortical excitability, as evidenced by lower~     cortico-motor threshold (MT) associated with the TA muscles following tDCS and training~     compared to following sham stimulation and training.~      H3: Participants in the tDCS+training group will show greater increases walking speed in a~     timed 10 meter walking trial.~      H4: Participants in the tDCS+training group will show be able to perform a greater number of~     toe-taps test.~   "
122620|NCT01962480|"~     Introduction: Closure of the hernia gap in laparoscopic ventral hernia repair before mesh~     reinforcement has gained increasing acceptance among surgeons despite creating a~     tension-based repair. Beneficial effects of this technique have sporadically been reported~     but no evidence is available from randomized controlled trials.~      The primary purpose is to compare early postoperative activity-related pain in patients~     undergoing ventral hernia repair with closure of the gap with patients undergoing standard~     laparoscopic ventral hernia repair (non-closure of the gap). Secondary outcomes are cosmesis~     and hernia-related quality of life (QoL) at 30-days and clinical or radiological recurrence~     and chronic pain after 2 years.~      Material and Methods: A randomized, controlled, double-blinded study is planned. Based on~     power calculation we will include 40 patients in each arm. Patients undergoing elective~     laparoscopic umbilical, epigastric, or umbilical trocar-site hernia repair at Hvidovre~     Hospital, Herlev Hospital, or Køge Hospital, who meet the inclusion criteria, are invited to~     participate.~      Conclusion: The technique with closure of the gap may induce more postoperative pain, but may~     be superior with regard to other important surgical outcomes. No studies have previously~     investigated closure of the gap in the setting of a randomised controlled trial.~   "
122606|NCT01962662|"~     Force generation and force level control are important neuromuscular control mechanism for~     successful execution of movement for our daily activities. Impaired force level control is a~     major deficit of motor control in people with stroke. Electromyographic biofeedback (EMG~     biofeedback) has been suggested by researchers and clinicians to be a useful and effective~     tool for enhancing control of force level during motor skill learning for people with stroke.~     Based on the concept of motor-skill learning, practice with variable force levels may be more~     effective than practice with a constant force level to enhance movement performance. The EMG~     biofeedback provides a suitable tool for such practice of force level control and hence for~     motor skill learning. However, research literatures thus far have yet to provide convincing~     evidences to support this claim. Neural imaging studies have shown corresponding brain~     reorganization and neural plasticity following physical practice of movement skills in people~     with stroke. It is curious whether EMG biofeedback augmented physical practice of motor~     skills enhances brain reorganization. Using brain mapping techniques, in particular, the~     transcranial magnetic stimulation (TMS), we could investigate neural plasticity accompanying~     motor function changes induced by physical training, and hence may help to develop safer and~     more effective training parameters. The purpose of this study is to examine the effects of~     variable practiced EMG biofeedback training emphasized on force level control of the ankle~     muscle on balance and gait performance and the corresponding changes of corticospinal~     excitability using TMS in people with chronic stroke.~   "
122607|NCT01962649|"~     This research study is evaluating an imaging contrast agent called indocyanine green, also~     known as ICG, in combination with image guided liver biopsies.~      In this research study, the investigators are looking at the ability of ICG to collect within~     liver tumors during biopsy. The participant will be receiving a biopsy of their liver as a~     part of their medical care. By participating in this trial, the only additional requirement~     will be for the participant to come to the hospital on the day prior to their scheduled~     biopsy to receive an injection of ICG. During the biopsy, the investigator will measure the~     amount of ICG that is in the participant's liver tumor by using two experimental devices~     designed by the study investigators that shine light on tissue. One device consists of an~     imaging system attached to a small borescope that will go inside the participant's body~     during the biopsy. The second device shines light on the biopsy sample outside of the~     participant's body after the biopsy has been taken. The participant may undergo imaging with~     one or both of these devices.~   "
122608|NCT01962636|"~     This is a treatment guideline for an unrelated umbilical cord blood transplant (UCBT) using a~     myeloablative preparative regimen for the treatment of hematological diseases, including, but~     not limited to acute leukemias. The myeloablative preparative regimen will consist of~     cyclophosphamide (CY), fludarabine (FLU) and fractionated total body irradiation (TBI).~   "
122609|NCT01962623|"~     The purpose of this study is to determine the feasibility and acceptability of utilizing an~     adapted form (i.e. IPT-MBD) of a psychosocial intervention, Interpersonal Psychotherapy for~     Depressed Adolescents, for youth with severe mood dysregulation (SMD) or disruptive mood~     dysregulation disorder (DMDD).~      The investigators hypothesize that retention rates will be >80%, satisfaction scores will~     average 6 (high) on a 7 point satisfaction scale, and that youth who receive the IPT~     intervention will have overall improvement in SMD/DMDD symptoms.~   "
122610|NCT01962610|"~     The goals of this exploratory study are to determine the feasibility of integrating~     electronic clinical decision support into routine clinical pain care for adults in the ED~     setting and gather data on whether or not such clinical decision support is effective in~     improving pain care outcomes in the ED. The use of an electronic pain care alert (ePCA)~     prompting doctors to provide acute pain care for adult patients with complaints of severe~     abdominal pain will be compared to patients seen by clinicians with routine ED care.~      Hypothesis: The ePCA will improve the quality of acute pain care for patients.~   "
122611|NCT01962597|"~     Study Hypothesis: The combination of aerobic and resistance exercise training will improve~     walking speed compared to either individual intervention.~      Brief Summary:~      Sixty hemodialysis participants who meet inclusion and exclusion criteria will be randomized~     to 20 weeks of supervised exercise, using either: (i) on-dialysis aerobic exercise using a~     bike ergometer; (ii) pre-dialysis leg strength training using weights; or (iii) both. The~     primary outcome is walking speed over 4-metres. Secondary outcomes will include:~      (i) short physical performance battery; (ii) health-related quality of life [EuroQOL-5D-5L];~     (iii) Dialysis recovery time; (iv) Nottingham extended activities of daily living (EADL)~     index; (v) Leg strength; (vi) body composition and anthropometry.~   "
122612|NCT01962584|"~     To evaluate the additive values of T1 mapping in patients with acute myocarditis.~   "
122613|NCT01962571|"~     This clinical trial aims at preventing visual dysfunction and optic nerve degeneration~     associated with autoimmune optic neuritis by systemic i.v. administration of 33.000 IU~     erythropoietin over 3 days. The primary objective is to determine the efficacy of~     erythropoietin compared to placebo given as add-on to methylprednisolone as assessed by~     measurements of retinal nerve fibre layer thickness and low contrast visual acuity 6 months~     after acute optic neuritis.~   "
122614|NCT01962558|"~     Assess the safety and efficacy of VNS paired with tones for tinnitus using a randomized,~     controlled, parallel study design.~   "
122615|NCT01962545|"~     The purpose of the study is to evaluate non-inferiority of oral anticoagulant (OAC)~     monotherapy to OAC plus single antiplatelet therapy (APT) in patients with atrial~     fibrillation (AF) and prior (>12 months) coronary stenting.~   "
122616|NCT01962532|"~     The purpose of this study is to determine a dose for future development and to evaluate the~     safety, pharmacokinetics, pharmacodynamics, and efficacy profiles of JNJ-42756493 in Japanese~     and other Asian patients with advanced or refractory solid tumors or lymphoma.~   "
122617|NCT01962519|"~     The aim of this study is to evaluate the possibility of shortening postoperative hospital~     stay after gastrectomy by early oral feeding as a component of an enhanced recovery protocol~     (ERAS).~   "
122618|NCT01962506|"~     Rapid and reliable exclusion of acute myocardial infarction (AMI) during an emergency~     department (ED) triage is a major unmet clinical need. We aimed at verifying the~     non-inferiority of a single-sampling strategy of hs-cTn and copeptin compared with the dual~     hs-cTn sampling for the early diagnosis of Non-ST-Elevation Acute Coronary Syndromes~     (NSTE-ACS) versus Non Coronary Chest Pain (NCCP) in a selected cohort of consecutive patients~     admitted at the Emergency Department.~   "
122621|NCT01962467|"~     This is an open label, randomized, 3-way cross-over, and repeat administration study in~     healthy male and female subjects. The purpose of the study is to determine the relative~     bioavailability of Fluticasone Furoate (FF) and Levocabastine (LEV), when each is~     administered alone and as FF/LEV Fixed Dose Combination (FDC).This study consists of Part A~     (in which 30 subjects including 12 Korean subjects will be enrolled) and Part B (in which 18~     subjects will be enrolled). Each part will consist of three treatment periods separated by a~     minimum washout period of 14 days. In each treatment period, subjects will receive seven~     daily doses of one of the 3 treatments: FF, LEV or FF/LEV FDC, via an intranasal spray~     according to one of the 6 possible randomization sequences. The study will use an adaptive~     design with an interim review following Part A to confirm whether Part B is required.~   "
122622|NCT01962454|"~     This is a single-blind, randomized placebo-controlled, parallel study, where the study~     volunteers will be blinded to testosterone/placebo treatment. This study will test a~     relatively new, less invasive method for collecting muscle tissue to determine if this method~     is appropriate for collecting muscle samples for the assessment of the fractional synthetic~     rates (FSR) of muscle-derived proteins. This study will also investigate whether the FSR of~     proteins may serve as early biomarkers for muscle anabolism, a known anabolic agent~     (testosterone) will be administered to healthy, elderly male subjects over a 3 week period.~     The fractional synthetic rate of several muscle-derived proteins will be analyzed at Baseline~     and during the period of testosterone treatment using deuterium labelling of these proteins~     by the incorporation of deuterium from deuterated water (D2O).~   "
122623|NCT01962441|"~     This study will assess the efficacy, safety, and tolerability of 16 or 24 weeks of sofosbuvir~     (Sovaldi®; SOF) + ribavirin (RBV), and 12 weeks of SOF+RBV+ pegylated interferon (Peg-IFN) in~     treatment-naive and treatment-experienced adults with chronic genotype 3 hepatitis C virus~     (HCV) infection, and treatment-experienced adults with cirrhosis and chronic genotype 2 HCV~     infection.~   "
122624|NCT01962428|"~     It is designed to test the hypothesis that high loading dose(360mg) ticagrelor versus~     conventional loading dose(180mg) will result in a higher inhibition of platelet~     aggregation(IPA) without increasing the bleeding events.~   "
122625|NCT01962415|"~     The objective of this study is to evaluate the efficacy of using a reduced-intensity~     condition (RIC) regimen with umbilical cord blood transplant (UCBT), double cord UCBT,~     matched unrelated donor (MUD) bone marrow transplant (BMT) or peripheral blood stem cell~     transplant (PBSCT) in patients with non-malignant disorders that are amenable to treatment~     with hematopoietic stem cell transplant (HSCT). After transplant, subjects will be followed~     for late effects and for ongoing graft success.~   "
122626|NCT01962402|"~     The purpose of this study is to determine whether lorcaserin is effective for weight~     reduction in patients with weight gain as a result of antipsychotic medications.~   "
122627|NCT01962389|"~     The study will evaluate the procedural safety and efficacy of the Winsor Laser Catheters for~     the treatment of In-Stent Restenosis (ISR) in the Superficial Femoral Artery (SFA)~   "
122628|NCT01962376|"~     The investigators assessed whether the addition of a preoperative regimen of Bevacizumab~     regimen to improves R0 resection rate and survival among patients with potentially resectable~     gastric cancer with liver metastasis.~   "
122629|NCT01962363|"~     The purpose of this study is to evaluate the effects of EPI-743 in patients with Friedreich's~     Ataxia point mutations~   "
122630|NCT01962350|"~     The treatment of bipolar disorders is always a challenge in daily practice. Mood stabilizers~     are partially effective in the treatment of depressive phase of the illness, although there~     are some reports relating to the antidepressant properties of these drugs. Other conventional~     methods (pharmacological) and non- conventional treatment are not effective or involve risks~     and side effects. Several studies with Transcranial Magnetic Stimulation (TMS) showed that~     magnetic stimulation daily over the left prefrontal cortex may improve the mood of patients.~     TMS is a noninvasive method of stimulating the brain. The instrument used nowadays in local~     research and application Clinical is a metallic coil formed in figure 8 (coil format 8). This~     instrument was capable of stimulating only surface areas of the brain, primarily the cerebral~     cortex, at depths of up to 3 inches below the scalp. From this angle, there is clearly a need~     for a means of producing magnetic fields which can reach deeper brain areas, such as those~     involved in mood disorders. TMS has little, if any effect in these brain areas. To this end,~     new coils, calls H, that promote the stimulation of deep brain areas were developed in~     collaboration with the National Institute of Health (NIH) in the USA. This new coil - H1 that~     will be evaluated in this study has been tested for safety in NIH in 2003 by Dr. Abraham~     Zangen. Yet there are very few prospective clinical, randomized and controlled trials, on the~     effects of early and late in clinical-cognitive condition and safety of TMS with H1 coils in~     treating episodes of bipolar depression. The application of EMT with H1 coils can reach~     deepest regions of the brain and improve the clinical and cognitive condition of subjects~     with episodes of bipolar depression, and may be confirmed as a safe and virtually free of~     side effects. By an absence of treatment actually effective for bipolar depression, this~     study will show whether there are clinical and cognitive benefits of deep TMS with H1 coil in~     patients with bipolar depression.~   "
122631|NCT01962337|"~     This is a Phase 1, randomized, double-blind, placebo-controlled study designed in 3 parts to~     assess the safety, tolerability, and PK of single and multiple ascending doses of FPA008 in~     adult healthy volunteers (Parts 1 and 2) and adult subjects with active RA (Part 3).~   "
122632|NCT01962324|"~     A single arm phase 2 study to study the outcome of dose-escalation with simultaneous~     integrated boost to intraprostatic lesion and positive lymph nodes. Prostate cancer patients~     with high risk of lymph node metastasis or oligo positive nodes in true pelvic area can be~     included. The boost volumes will be outlined by usin PET-CT and MRI data. Our hypothesis is~     that we will have fewer relapses in this very high risk patient group compared to matched~     historical controls with acceptable side effects.~   "
122633|NCT01962311|"~     This project is expected to answer the question of interest assays of metabolites in the CSF~     as a tool for early diagnosis and should show whether it is possible or not to use such~     markers in the blood or urine. These studies should also help shed light on the~     pathophysiological original early clinical disease. While ALS appears to be more a clinical~     syndrome that pathophysiological entity unique metabolic abnormalities identified could help~     identify mechanisms disrupted in which therapeutic interventions will be possible.~   "
122634|NCT01962298|"~     The effect of neuromuscular blocking agents (NMBA, e.g. rocuronium) on respiratory muscle~     activity is well known. However, since the availability of sugammadex, to our knowledge, no~     study has been conducted to evaluate the effect of this novel product on these muscles.~      Our hypothesis is that by applying a different strategy in the use of neuromuscular blocking~     agents and their reversal agents we might see a different activity of the respiratory~     muscles.~   "
122635|NCT01962285|"~     Loss and recovery of consciousness during propofol anesthesia seem to be mediated by~     different mechanisms beyond the actual effect-site concentration of anesthetic drug. This~     eventual difference between dose response curves for loss of consciousness (LOC) and for~     recovery of consciousness (ROC) beyond hysteresis has received the name of neuronal inertia.~     We performed a volunteer-study comparing LOC and ROC curves during a slow, steady-sate,~     stepped target controlled infusion of Propofol. Our hypothesis is that, at steady-state~     conditions between plasma an effect-site concentration, there is still going to exist a~     difference between LOC and ROC, demonstrating the existence of neuronal inertia.~   "
122636|NCT01962272|"~     Background and aims: Cancer-related malnutrition is multifactorial and related to a bad~     prognosis. The aim of this study was to investigate the effect of intensive, individual~     dietary counseling of patients in radiotherapy and/or chemotherapy for gynecologic-,~     gastric-, or esophageal cancer.~   "
122637|NCT01962259|"~     The aim of present randomized controlled trial is to evaluate the health effects of physical~     activity in transport and leisure time domains of everyday life and to develop durable~     physical activity regimens, i.e. to go from lifestyle intervention to daily lifestyle~     routine, in overweight individuals.~      Subjects will be randomized to 1 of 4 groups. 1: Vigorous intensity leisure time physical~     activity, 2: Moderate intensity leisure time activity, 3: Active commuting by bicycle, or 4:~     a non-intervention control group~   "
122638|NCT01962246|"~     Stage I：preoperative therapy~        -  Capecitabine plus oxaliplatin with concurrent radiotherapy is superior to surgery alone~          ; Stage II: Perioperative therapy~        -  Perioperative Capecitabine plus oxaliplatin with Concurrent radiotherapy is superior to~          adjuvant Capecitabine plus oxaliplatin alone;~        -  A regimen of Capecitabine plus oxaliplatin(XELOX) improves survival among patients with~          incurable locally advanced or metastatic adenocarcinoma of stomach and gastroesophageal~          cancer . The investigators assessed whether the addition of a perioperative regimen of~          XELOX regimen with concurrent radiotherapy to adjuvant alone improves R0 resection rate~          and survival among patients with curable locally advanced adenocarcinoma of stomach and~          gastroesophageal cancer~   "
122639|NCT01962233|"~     This study is to evaluate the safety and efficacy of Umbilical Cord Derived Mesenchymal Stem~     Cells transplantation in hypoxic ischemic encephalopathy.~   "
122640|NCT01962220|"~     Linking HIV-infected pregnant women into prevention of mother to child transmission (PMTCT)~     services and keeping them in care is important in ensuring that both mother and infant beneﬁt~     from interventions that improve maternal health and decrease HIV transmission to infants. We~     propose an evaluation of strategies to link newly diagnosed HIV-infected women to care and~     keep them in care during pregnancy and after delivery in our study called MIR4HEALTH. The~     study will be conducted in Nyanza Province, Kenya. All participants will provide informed~     consent and will be randomized to receive the intervention, including individualized patient~     education, adherence support and phone call/Short Message Service (SMS) reminders for clinic~     appointments, or the standard of care (no additional intervention services).~   "
122641|NCT01962207|"~     The purpose of this study is to evaluate the long-term antibody persistence 6, 7, 8, 9 and 10~     years after receiving a primary vaccination of meningococcal conjugate vaccine MenACWY-TT~     versus Meningitec™ or Mencevax™ ACWY, and the safety and immunogenicity of a booster dose of~     MenACWY-TT administered 10 years after the primary vaccination. All subjects received a~     primary vaccination at 1 to 10 years of age in study 108658 (NCT00427908). No new subjects~     will be enrolled in this booster study.~   "
122642|NCT01962194|"~     The investigators hypothesize that the emotional and cognitive areas of the Subthalamic~     Nucleus (STN) have distinct electrophysiological properties and that specific stimulation of~     these areas can influence the mental and the emotional state. Parkinson's disease (PD; n=5)~     and obsessive-compulsive disorder (OCD; n=5) patients that are candidates for treatment with~     Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) will be recruited over a period of two~     years. The patients will be enrolled in a prospective, open label, clinical trial and will be~     followed for one year. No randomization or blinding will be used in this study.~   "
122643|NCT01962181|"~     In this study we try to identify the signature of brain activity in the EEG of attention~     deficit disorder (ADHD) patients compared to healthy subjects under different doses of~     Ritalin (methylphenidate) treatment.~   "
122644|NCT01962168|"~     The Evolution® Biliary Stent System Clinical Study is a clinical trial on a commercially~     available device to gather physician experience with the Cook Evolution® Biliary Stent System~     for the palliation of cancer in the biliary tree. Patients will be treated as per usual~     medical practices.~   "
122645|NCT01962155|"~     The aim of our prospective study is to construct and validate a non-invasive model consisting~     biochemical markers, FibroScan, and radiological parameters for evaluating liver fibrosis~     caused by hepatitis B virus in mainland China.~   "
122646|NCT01962142|"~     Limitation of activity is one of the main item used by composites scores designed to assess~     the level of asthma control. Since this item is systematically subjectively assessed by the~     patient, the investigators would like to know if these subjective data are correlated with~     objective data.~      Aims of this study are: 1) To describe what means limitation of activity for asthma~     patients and how they deal with; 2) To describe the objective exercise capacity and~     characteristics of daily activity in two situations (on exacerbation, out of an~     exacerbation).~   "
122670|NCT01961830|"~     This is a single-center, open-label, single-dose study. The primary objective is to determine~     Epithelial Lining Fluid (ELF) levels of ME1100 after a single orally inhaled dose. The~     secondary objectives are to determine systemic exposure to inhaled ME1100 and to assess~     tolerability and safety of a single dose of ME1100 inhalation solution.~   "
122671|NCT01961817|"~     Is there a difference in vocal cord visualization between the retromolar and conventional~     access?~   "
122787|NCT01960296|"~     Patients who on taking clopidogrel are randomized to either continue clopidogrel into general~     surgery or discontinue clopidogrel 7 days before surgery. All patients resume clopidogrel~     after surgery. The investigators track the development of bleeding complications that may~     develop within 90 days of the surgery. Patients are medically cleared to be in either arm of~     the study by their cardiologist and surgeon. There is currently no evidence to support for or~     against the use continuation or discontinuation of clopidogrel prior to general surgery.~   "
122647|NCT01962129|"~     The aim of this multicentre study will be to better describe the clinical characteristics and~     the etiological bases of patients with OFD syndrome by identifying new genes involved in OFD~     syndrome. These results will make it possible, from patients who have been clearly identified~     from a clinical, cytogenetic and molecular point of view, to determine a study strategy in~     such patients. The data obtained will be used to guide clinical geneticists in genetic~     counselling for patients and their families.~      Identification of the molecular bases of the different OFD syndromes will make it possible to~     determine whether or not they belong to the group of ciliopathies like type I OFD and to~     understand their physiopathological bases.~      This study will also make it possible to better characterise the phenotype of boys with~     syndromic mental retardation related to the OFD1 gene and thus to define the clinical~     criteria of the study of this gene in boys with mental retardation.~      The complete absence of knowledge concerning the genetic bases of OFD syndromes, apart from~     type I, the presence of a large collection of samples from patients with OFD syndrome at~     Dijon CHU, the recognition of the diagnostic laboratory for syndromic OFD at the~     international level as well as the technical platform and expertise in molecular cytogenetic~     methods including CGH-array and molecular genetics (sequencing, quantitative PCR, fragment~     analysis) at the Cytogenetics and Molecular Biology laboratories at Dijon CHU justify the~     implementation of such a study in 2010.~   "
122648|NCT01962116|"~     After obtaining written informed consent and inclusion, patients will be randomised into 2~     groups for the type of dialysis catheter lock:~        -  The first group will have a citrate lock~        -  The second group will have a heparin lock Patients will be stratified according to the~          centre and type of Renal Replacement Therapy (RRT) continuous or intermittent.~      The daily surveillance of patients will be no different from the usual surveillance of~     patients on Renal Replacement Therapy.~      The hemodialysis catheters used will be specific Renal Replacement Therapy catheters.~      The decision to withdraw the catheter will be made by the investigator and based on clinical~     criteria (complications related to the catheter, termination of Renal Replacement Therapy…)~   "
122649|NCT01962103|"~     The purpose of this study is to find the safe dose of nab-paclitaxel in children with solid~     tumors, and to see if it works to treat these solid tumors in children and young adults (in~     phase 1 ≤ 18 years old and in phase 2 ≤ 24 years old). After the final dose has been chosen,~     patients will be enrolled according to the specific solid tumor type, (neuroblastoma,~     rhabdomyosarcoma, or Ewing's sarcoma), to see how nab-paclitaxel works in treating these~     tumors.~   "
122650|NCT01962090|"~     This study is designed to compare the short term effects of two different thoracic spine~     thrust manipulation techniques on neck range of motion, pain, and self-reported disability in~     a sample of dental students experiencing neck pain.~      The hypothesis of the study is that there will be a difference between the two thoracic spine~     thrust manipulation techniques for short term effects on neck range of motion, pain, and~     self-reported disability in a sample of dental students experiencing neck pain.~   "
122651|NCT01962077|"~     assess the effect of MedCem MTA as a pulp medicament following pulpotomy in human primary~     molars with carious pulp exposure in comparison to Formocresol.~   "
122652|NCT01962064|"~     The purpose of this study is to examine the age and the neurodegenerative disease effects on~     social cognition. Secondary goals are to better understand the relationships between~     different component of social cognition, executive functioning, and behavior and describing~     the neuronal substrates associated to the alteration of the social cognition in ageing and~     dementia.~   "
122653|NCT01962051|"~     The ACP device will be clinically evaluated through a prospective, open-label, nonrandomized,~     multi-center post market clinical study.~   "
122654|NCT01962038|"~     The purpose of this study is examine the efficacy of a combination physical exercise and~     cognitive training program on improving memory in older Veterans with amnestic Mild Cognitive~     Impairment.~   "
122655|NCT01962025|"~     The purpose of the pilot study is to determine: 1) Will patients agree to be randomized to~     two different methods of putting needles in their arteriovenous fistula and, 2) if we can~     adequately coordinate all of the sites to get useful multicentre trial data~   "
122656|NCT01962012|"~     The purpose of this study is to examine the amount of tooth movement achieved over time~     between subjects undergoing aligner treatment using a pulsation device known as AcceleDent®~     Aura with those not using the device.~   "
122657|NCT01961999|"~     The question of timing of initiation of renal replacement therapy (RRT), early versus~     late, has seldom been the focus of high-quality or rigorous evaluation. As a consequence,~     initiatives aimed at identifying the optimal timing of initiation of RRT in acute kidney~     injury (AKI) have been given the highest priority for investigation by the Acute Kidney~     Injury Network (AKIN). Accordingly, the investigators conducted a prospective, controlled,~     interventional trial, comparing two treatment groups in which the only variable was the RRT~     initiation strategy, to determine whether early versus late initiation in patients with~     AKI after cardiac surgery is associated with a survival benefit or more favorable outcomes.~   "
122658|NCT01961986|"~     Design: Prospective, randomized clinical trial, of 120 patients requiring a total shoulder~     replacement (TSR).~      Purpose: To collect and evaluate long-term clinical data on patients whose total shoulder~     replacement (TSR) is performed using the traditional surgical approach (called the~     subscapularis release approach) as compared to patients who have a TSR procedure done using a~     newer surgical approach (called the rotator cuff sparing approach).~   "
122672|NCT01961804|"~     The occurence of a minor craniocerebral trauma in patients receiving vitamine K antagonist~     treatment leads to a high risk of bleeding.~      Current guidelines recommend to perform a CT scan, and, in case of intracranial bleeding, to~     reverse anticoagulation with concomitant administration of prothrombin complex concentrates~     (PCCs) and vitamin K.~      However, even if a reversion is performed, the prognostic of post-traumatic intracranial~     bleeding remain bad.~      The investigators hypothesize that, for patients admitted in an emergency department after a~     minor head trauma and receiving anticoagulant treatment, a systematic preventive reversion~     with PCCs can lead to a significant reduction of intracranial haemorrhage and can also~     improve the neurological prognostic of patients versus the current strategy.~      PREVACT will test this hypothesis, in an open label, randomized, multicentre, clinical trial~     involving 400 patients.~   "
122659|NCT01961973|"~     Study Title: A study to compare two articular cartilage repair techniques in the knee joint:~     The use of Cultured Chondrocytes Vs. Cultured bone marrow aspiration cells.~      Study hypothesis: We start with the hypothesis that both treatments are equally effective.~      Trial Design: The participating patients will be divided into two groups, each group~     receiving either one of the treatment modalities. This study will not be randomised or~     blinded. Both procedures will be done at the Spire Alexandra Hospital by Professor A. A~     Shetty, who is one half of the team that devised both techniques. The post-operative~     rehabilitation process will be the same for both groups.~      Trial Participants: All participants will be from patients attending Professor Shetty's~     clinic at the Spire Alexandra Hospital.~      Planned Sample Size: 50 patients in each group~      Follow-up duration: The participating patients will be followed up at 2 weeks, 6 weeks, 3~     months, 6 months, 1 year and 2 years following the surgery by visits to the clinic and~     assessed clinically. The surgical outcomes will be measured by by IKDC, KOOS and Lysholm~     scores; cartilage growth will be measured by the MOCART score.~      Planned Trial Period: Two to three years~      Primary Objective: To establish superiority, if any, of either procedure over the other by~     studying pain relief, cartilage growth and improvement in function.~      Primary Endpoint: At the end of the 2 year follow up for all participating patients.~   "
122660|NCT01961960|"~     The purpose of this study is to evaluate safety and immunogenicity of intramuscular ASP7374~     in adults ≥61 years of age.~   "
122661|NCT01961947|"~     The purpose of this study is to compare immunogenicity and safety of ASP7374 (cell-culture~     derived influenza vaccine) with those of approved egg-derived trivalent inactivated vaccine~     (TIV) in adults ≥20 and <65 years.~   "
122662|NCT01961934|"~     This study will investigate how well Carbon Acetate PET/CT imaging helps to correctly~     identify recurrent tumor versus post treatment effects (radionecrosis) in patients with~     previously treated high grade brain gliomas.~   "
122663|NCT01961921|"~     The purpose of this study is to evaluate the safety and tolerability of long-term dosing with~     ALN-TTR02 (patisiran) in patients with transthyretin (TTR) mediated amyloidosis (ATTR).~   "
122664|NCT01961908|"~     This study is a phase 2, open-label extension study of 12 mg Proellex for 2 treatment cycles,~     each with a 16 week active dosing period. Endometriosis pain, dysmenorrhea, non-menstrual~     pelvic pain and dyspareunia (BBSS) as well as use of pain medications, and vaginal bleeding~     intensity will be recorded using an electronic diary and Visual Analog Scale (VAS) pain~     assessment will be utilized. All subjects will have completed an Off-Drug Interval (ODI)~     prior to starting treatment. Visit 1 will be scheduled within a week before the next expected~     menses (+/- 2 days), following the off-drug interval. Subjects will receive 2 cycles of~     treatment separated by an off-drug interval (ODI), after which they will be followed until~     menses has returned. During the follow-up period subjects will continue to record study~     information in the electronic diary. The final follow-up visit will be scheduled after blood~     flow has stopped.~   "
122665|NCT01961895|"~     The purpose of this study is evaluate the efficacy of perioperative continuous lumbar plexus~     block in reducing the risk of cardiac ischemic events of elderly patients undergoing surgery~     for hip fractures, expressed as a reduction of ischemic events per subject.~   "
122666|NCT01961882|"~     To compare disease-free survival in patients 60 years or older with acute myeloid leukemia~     (AML) who are randomly assigned to receive either OCV-501 monotherapy or placebo.~   "
122667|NCT01961869|"~     This clinical trial studies black raspberry confection in preventing oral cancer in healthy~     volunteers. Black raspberry contains ingredients that may prevent or slow the growth of~     certain cancers.~   "
122668|NCT01961856|"~     In the PLATO substudy referring to patients presenting with an ST-elevation Myocardial~     Infarction(STEMI), out of the 4201 who received ticagrelor, 1326 had been pre-treated with a~     600mg clopidogrel loading dose (LD) within 24 hours prior to randomization. It is a logical~     assumption, that patients who are being reloaded with ticagrelor will demonstrate reduced~     platelet reactivity (PR) at 24 hours, in comparison to those who were initially loaded with~     ticagrelor, due to the synergistic antiplatelet effect. Single loading with ticagrelor~     though, will possibly be accompanied by a smaller bleeding potency compared to reloading with~     ticagrelor. Therefore, we assume that single loading with ticagrelor is non-inferior to~     reloading with ticagrelor, in terms of platelet reactivity.~      P2Y12 inhibitor naive patients with STEMI, they will be randomized immediately after coronary~     angiography (Hour 0) in receiving either Ticagrelor 180mg LD or Clopidogrel 600mg LD and 2~     hours later reloading with Ticagrelor 180mg, after written informed consent. PR will be~     measured, using the VerifyNow assay at randomization (Hour 0) and at 2, 4, 6 and 24 hours~     post randomization. In addition, a 12-lead ECG will be performed before randomization, 90 and~     180 minutes after the first balloon inflation, as well as on the exit day. Troponin I and~     CK-MB will be assessed at randomization and at hour 4, 12, 24, 48 and 72 after randomization.~      Non inferiority of Ticagrelor LD versus Ticagrelor re-LD would be accepted if the upper bound~     of the 2-sided 95% CI around the estimated LS mean difference (Ticagrelor LD minus Ticagrelor~     re-LD) in the primary end point (PR at 24 hours) would lie bellow Δ=35 PRU. This~     non-inferiority margin (Δ) represents the upper bound of the LS mean difference in PR between~     Ticagrelor and Prasugrel arm at 24 hours after LD in a pharmacodynamic study of 55 STEMI~     patients.~      Considering previous studies PR at 24 hours post randomization was estimated at 47±40 PRU and~     41±35 PRU for Ticagrelor only LD and Ticagrelor re-LD group respectively. To obtain 85%~     statistical power with a 2-sided alpha=0.05, approximately 32 patients in each treatment~     group (64 in total) would be needed to establish the primary hypothesis using the~     abovementioned non-inferiority margin of 35 PRU. Anticipating a 5% dropout rate, enrollment~     was set to at least 68 patients. The primary endpoint, as well as PR at all the other time~     points of the study will be analyzed separately via a mixed effect model with treatment as~     fixed effect, patient as a random intercept and PR at baseline as a covariate. Least squares~     estimates of the mean difference will be presented, with 95% confidence intervals and a~     two-sided p-value for the treatment effect. P values for secondary endpoints will be reported~     for two-tailed tests of superiority.~   "
122669|NCT01961843|"~     This research study is a Pilot clinical trial. Pilot clinical trials often examine new tests~     (such as laboratory or radiology tests) in patients who receive either standard cancer~     treatments or new treatments that have been well-tested in many patients on other trials.~      It is often difficult to determine how prostate cancer is going to behave when a new~     treatment is started. Physicians have no way to predict how a patient's tumor will respond to~     treatment. Although scientists have learned about changes that happen in tumors due to~     treatment, it is difficult to get cells from tumors because a biopsy (surgical procedure to~     remove a small piece of tissue) is needed.~      This study will evaluate a method to detect tumor cells that are circulating in the blood~     without getting a biopsy. It is known that tumors shed a small number of cells into the blood~     stream every day. These are called circulating tumor cells or CTCs. Some early studies~     indicate the amount and type of CTCs in the blood can help determine the status of the tumor~     itself and the way it is responding to treatment. In this study, the investigators will~     examine protein levels in CTCs from patients' blood at different times before and after drug~     treatment to determine if they correlate with response to the drug. The new test will not~     affect whether subjects continue on the study drug.~      Abiraterone acetate is a marketed drug that has been studied for the treatment of metastatic~     CRPC. It blocks the remaining or residual male hormones in the body that may be helping~     prostate cancer to grow. Abiraterone acetate is now FDA-approved for patients with metastatic~     CRPC who have not yet received docetaxel chemotherapy.~      Abiraterone acetate has been used by a large number of participants in previous clinical~     trials. In most of these trials, participants with CRPC have been given abiraterone acetate~     with prednisone. Prednisone is a man-made hormone commonly referred to as a steroid.~     Prednisone has been approved in the US, Canada, and Europe for various disorders and~     diseases, such as asthma, Lupus and chronic obstructive lung disease. The combination of~     prednisone with abiraterone acetate has been approved for the treatment of CRPC. Prednisone~     together with abiraterone acetate will be given in this study in order to reduce or eliminate~     some side effects. Investigators will use patients' blood samples to study the genes (also~     called DNA) and their products (RNA and proteins) found in CTCs.~   "
122673|NCT01961791|"~     For staging the status of lymph node metastasis in gastric cancer, typographic based staging~     system was applied until last decade, especially in Eastern countries. However the old~     typographic lymph node staging system in gastric cancer was too complicated and less accurate~     for predicting the prognosis. Now the numeric based lymph node staging system is used in both~     East and West, but it include problems: no information on the anatomical extent of the~     disease, preoperative lymph node staging is nearly impossible, failure to provide an~     appropriate treatment plan, cannot represent the extent of lymph node dissection. We designed~     simple and specifically representing the anatomic extent of the disease for staging the~     status of lymph node in gastric cancer. Thus we compared its prognostic performance of this~     new staging system with those of the current TNM 7th edition of AJCC/UICC.~   "
122674|NCT01961778|"~     The two treatment modalities under investigation are clinically equivalent (non-inferior) to~     each other for the endoscopic treatment of Barrett's esophagus with HGD and/or early~     esophageal adenocarcinoma.~   "
122675|NCT01961765|"~     This research study is evaluating a drug called cabozantinib as a possible treatment for~     acute myeloid leukemia (AML). This research study is a Phase I clinical trial. Phase I trials~     test the safety of an investigational drug or combination of drugs. Phase I studies also try~     to define the appropriate dose of the investigational drug to use for further studies. This~     means that the FDA has not approved giving cabozantinib for use in patients, including~     patients with your type of cancer.~      The study drug cabozantinib works by inhibiting several different proteins which are believed~     to be involved in the growth and multiplication of the cancerous cells associated with acute~     myeloid leukemia. This drug has been used in other research studies and information from~     those other research studies suggests that this drug may help to prevent cancer growth.~      The primary purpose of this research study is to determine the highest dose of Cabozantinib~     that can safely be given without severe or unmanageable side effects. The dose identified in~     this study will be used in future research studies that seek to determine the role of~     cabozantinib as a treatment for AML.~   "
122676|NCT01961752|"~     Although pain is a common complication of endoscopic submucosal dissection (ESD), management~     strategies are inadequate. bupivacaine is used for visceral pain control in chronic pain and~     in pain associated with surgery in clinical practice. Further, triamcinolone, a type of~     steroid, is often mixed with bupivacaine to lengthen the analgesic effect. The aim of this~     study was to evaluate the efficacy of topical bupivacaine and triamcinolone acetonide for~     abdominal pain relief and as a potential method of pain control after ESD for gastric~     neoplasia. We hypothesized that topical bupivacaine and/or triamcinolone acetonide injection~     after ESD would be effective for pain relief. For this, we designed randomized, double-blind,~     placebo-controlled trial. Eligible patients with early gastric neoplasm were randomized into~     one of three groups: bupivacaine (BV) only, bupivacaine with triamcinolone (BV-TA), or~     placebo. To evaluate the pain after ESD, the Present Pain Intensity (PPI) score and the~     Short-Form McGill Pain Questionnaire (SF-MPQ) were used to evaluate pain at 0, 6, 12 and 24 h~     after ESD.~   "
122677|NCT01961739|"~     The primary objective of this study is to evaluate the efficacy of topical 2% lidocaine in~     the therapy of symptomatic hemorrhoids. Efficacy will be determined by:~        1. the change from baseline in pain, itching, bleeding, swelling, discomfort, general~          well-being and improvement since the beginning of treatment as separate components of~          CORRECTS scale~        2. the change in overall CORRECTS values from baseline~        3. the change in degree of hemorrhoids from baseline~   "
122678|NCT01961726|"~     A phase I/II study to evaluate the safety and efficacy of JVS-100 administered by retrograde~     delivery to cohorts of adults with Ischemic Heart Failure.~   "
122679|NCT01961713|"~     This study will evaluate a method to detect tumor cells that are circulating in the blood~     without getting a biopsy. The investigators already know from other studies that cancer~     tumors shed a small number of cells into the bloodstream every day. These are called~     circulating tumor cells (CTCs). Some early studies indicate the amount and type of CTCs in~     the blood can help determine the status of the tumor itself and the way it is responding to~     treatment. In this study, the investigators will compare the number of CTCs in the blood at~     different time frames before and after surgery to remove the prostate.~   "
122680|NCT01961700|"~     Lung cancer is one of the most common types of cancer in the world, and the cancer that~     causes the most number of deaths. In Sweden, about 3700 persons are diagnosed every year.~     About one fifth of the patients are eligible for surgery.~      Patients undergoing thoracic surgery suffer from pain and low health related quality of life~     after surgery.~      In Australia, New Zealand, and the United Kingdom, pre- and postoperative physiotherapy is~     routinely provided for patients undergoing thoracic surgery, but the effects have not been~     thoroughly investigated. The scientific evidence of the effect of physiotherapy in connection~     with lung surgery is limited. The treatment typically consists of early mobilisation,~     breathing exercises and exercises for the shoulders. Reeve et al has shown that a~     postoperative shoulder exercise program can improve function and decrease pain after~     thoracotomy. Breathing exercises has not been found effective in reducing the rate of~     postoperative pulmonary complications after thoracic surgery.~      The purpose of this study is to investigate the effect of in-hospital physiotherapy~     treatment, for patients undergoing thoracic surgery, on physical activity, health related~     quality of life, pain and lung function.~   "
122681|NCT01961687|"~     Single-arm study of Phasix Mesh in High Risk patients looking at SSI and recurrence rates.~   "
122682|NCT01961674|"~     The primary hypothesis of this study is that consumption of capsinoids increases brown~     adipose tissue activity, detectable by infrared thermal imaging.~      The secondary hypothesis is that consumption of capsinoids can affect an individual's~     glycaemic response.~   "
122702|NCT01961414|"~     The purpose of this research study is to determine if a Treat and Extend regimen~     (increasing the time between visits when the disease is stable and not getting worse) of~     aflibercept 2.0mg injections inside the eye for treating patients with Wet Age-related~     Macular Degeneration.~   "
122788|NCT01960283|"~     Chronic urticaria is defined by urticarial lesions persisting at 6 weeks. The cause is not~     found in about 75% of cases (chronic idiopathic urticaria). The gold standard treatment~     consists of anti-H1 molecules. In severe cases, refractory to anti-H1, few therapeutic~     alternatives exist. Methotrexate, which is not expensive and often prescribed by~     dermatologists, has been efficiently tried in an open study on severe chronic idiopathic~     urticaria, and also in few case reports.~   "
122683|NCT01961661|"~     Cystic fibrosis (CF) is a complex systemic disease that mainly involves the respiratory and~     gastrointestinal (GI) tracts. The polymicrobial community composition of respiratory and GI~     tracts is influenced by both genetic and environmental factors. Children with CF may harbor~     an abnormal intestinal microflora, because of altered Cystic fibrosis transmembrane~     conductance regulator (CFTR) function and heavy drug load (antibiotics, pancreatic enzymes~     and acid suppressors). The investigators previously demonstrated that intestinal inflammation~     is highly frequent in CF children, being a major feature of intestinal involvement. In~     addition, specific probiotics significantly improved airway and GI inflammation in a~     preliminary trial. The aim of the study is to characterize intestinal and respiratory~     microflora in CF patients and to investigate the effects of daily Lactobacillus GG (LGG)~     supplementation on both GI and airway microflora and the eventual relationship between~     probiotic assumption and clinical and inflammation markers. The aim is to study the effect of~     microflora modification on intestinal and extraintestinal inflammation to eventually improve~     the quality of life of CF patients, who often suffer from intestinal and respiratory~     progressive disease, through a non invasive intervention consisting in the supplementation of~     probiotic bacteria.~   "
122684|NCT01961648|"~     This study is being conducted to determine whether inhaling exhaled carbon dioxide is~     effective for the treatment of sleep apnea. A mild increase in this gas can stimulate the~     respiratory drive by 2-3 fold, which in turn can stimulate the upper airway dilator muscles~     and decrease the severity of obstructive sleep apnea by at least 50% in selected patients.~   "
122685|NCT01961635|"~     In patients that require a dental implant, does zirconia compared to titanium, or cad-cam~     acrylic abutments, provide less inflammation, marginal bone loss or infection during the~     osseointegration period ?~   "
122686|NCT01961622|"~     The main objective of this study is to determine whether day and night closed-loop insulin~     delivery for 12 weeks under free living conditions is superior to addition of real-time~     continuous glucose monitoring in adults with type 1 diabetes and sub-optimal glucose control~     on insulin pump therapy.~      This is an open-label, multi centre, randomised, crossover design study, involving a 6 to 8~     week run-in period, during which glucose control will be optimised by a professional pump~     educator, followed by two 3 months study periods during which glucose levels will be~     controlled either by an automated closed-loop system or by subjects usual insulin pump~     therapy augmented with real-time continuous glucose monitoring in random order. A total of up~     to 42 adults (aiming for 30 completed subjects) aged 18 years and older with T1D on insulin~     pump therapy will be recruited through diabetes clinics and other established methods in~     participating centres. Subjects who drop out of the study within the first 6 weeks of the~     first intervention arm will be replaced.~      Subjects will receive appropriate training in the safe use of closed-loop insulin delivery~     system. Subjects will have regular contact with the study team during the home study phase~     including 24/7 telephone support. Subjects will be discouraged from international travel~     during the first two weeks of closed-loop use.~      The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L as recorded by~     CGM (adjusted for potential over-estimation) during home stay. Secondary outcomes are the~     HbA1c, time spent with glucose levels above and below target, as recorded by CGM, and other~     CGM-based metrics.~   "
122687|NCT01961609|"~     This study is designed to prove and quantify the hypothesis that secukinumab is effective,~     safe and well tolerated in the treatment of moderate to severe chronic plaque-type psoriasis~     in patients who are inadequate responders to anti-TNFα therapy in a UK (and Republic of~     Ireland) specific population.~   "
122688|NCT01961596|"~     The aim of this study is to investigate the influence of a brief application of cold (by~     means of Cooling Ice Spray on the lateral ankle)on the time to stabilization of healthy~     subjects.~   "
122689|NCT01961583|"~     Positron emission tomography (PET) is a non-invasive imaging tool for monitoring functional~     and metabolic responses of biological events with specific radiotracer in vivo. The PET~     tracer [18F]Fluciclatide is an 18F radiolabeled small peptide containing the RGD~     (arginine-glycine-aspartate) tri-peptide, which preferentially binds with high affinity to~     αvβ3 and αvβ5 integrins. αvβ3-integrins are expressed at low levels on epithelial cells and~     mature endothelial cells but are expressed at high levels on activated endothelial cells in~     the neo-vasculature of a range of tumors and it also may regulate angiogenesis. If pazopanib~     acts mainly on active angiogenetic tumors, the quantitative uptake of [18F]Fluciclatide can~     be used to predict the effect of this antiangiogenic drug. The investigators expected the~     baseline tumor uptake in [18F]Fluciclatide to be able to predict treatment response, and~     planned a study of [18F]FluciclatidePET for patients with metastatic RCC who received~     pazopanib systemic therapy.~   "
122690|NCT01961570|"~     This study is to evaluate the performance of the Articulinx ICMC~     (InterCarpoMetacarpalCushion)in the carpometacarpal joint (CMC joint) and to describe the~     clinical results in patients who have been treated with this device. Expected results include~     the relief of symptoms and improvement of function in patients with symptomatic~     osteoarthritis (OA) of the CMC-1 joint. Evaluation of device performance will be achieved~     through measurements of pain, pain medication use, and joint function in up to 20 subjects.~     Each subject will be compared to their pre-surgery status for each endpoint.~   "
122703|NCT01961401|"~     Exercise training is recognized as effective in preventing and treating many chronic~     metabolic disorders (1), and long-term exercise programmes have similar effects on glucose~     control as long-term drug or insulin therapy in type 2 diabetic patients (2). The precise~     intensity and volume of aerobic exercise needed to produce the most wanted effects on~     targeted risk factors for subjects at risk of/with established type 2 diabetes, is still~     uncertain. In this study the investigators will investigate the acute effects of a single~     bout of moderate versus high intensity exercise on insulin sensitivity in pregnant women with~     and without gestational diabetes mellitus (GDM). The investigators think that very short~     bouts of high intensity exercise can be a way to reduce blood glucose in these women.~   "
122869|NCT01959230|"~     To compare the efficacy and safety of brimonidine tartrate ophthalmic solution 0.025% with~     its vehicle for treating ocular redness in a population of adult and geriatric participants~     with ocular redness.~   "
123096|NCT01956240|"~     The purpose of this study is to verify the effects of a stretching protocol for the~     pectoralis minor muscle on its resting length and on the 3D kinematics of the scapula during~     arm flexion in asymptomatic subjects and patients with impingement syndrome with shortened~     pectoralis minor.~   "
122691|NCT01961557|"~     Background:~      - Cerebral palsy (CP) is the most common motor disorder in children. CP often causes crouch~     gait, an abnormal way of walking. Knee crouch has many causes, so no single device or~     approach works best for everybody. This study s adjustable brace provides many types of~     walking assistance. Researchers will evaluate brace options to find the best solution for~     each participant, and whether one solution works best for the group.~      Objective:~      - To evaluate a new brace to improve crouch gait in children with CP.~      Eligibility:~        -  Children 5 17 years old with CP.~        -  Healthy volunteers 5 17 years old.~      Design:~        -  All participants will be screened with medical history and physical exam.~        -  Healthy volunteers will have 1 visit. They will do motion analysis, EMG, and EEG~          described below.~        -  Participants with CP will have 6 visits.~        -  Visit 1:~      <TAB>1. Motion analysis: Balls will be taped to participants skin. This helps cameras follow~     their movement.~      <TAB>2. EMG: Metal discs will be taped to participants skin. They measure electrical muscle~     activity.~      <TAB>3. Participants knee movement will be tested.~      <TAB>4. Participants will walk 50 meters.~      <TAB>5. Participants legs will be cast to make custom braces.~        -  Visit 2:~        -  Participants will wear their new braces and have them adjusted.~        -  Steps 1 3 will be repeated.~        -  EEG: Small metal discs will be placed on the participants scalp. They record brain~          waves.~        -  Participants will have electrical stimulation of their knees and practice extending~          them.~        -  Participants will take several walks with the braces in different settings.~        -  Visits 3 5: participants will repeat the walking and some other steps from visit 2.~        -  Visit 6 will repeat visit 2.~   "
122692|NCT01961544|"~     This clinical study is designed as an open, single group, multi-center, phase 4 clinical~     study to assess the safety of eribulin which is approved for the treatment of the patients in~     Korea with locally advanced or metastatic breast cancer who had received two to five prior~     chemotherapy regimens including anthracyclines and taxanes for advanced disease.~      Subjects who meet the inclusion/exclusion criteria are administered of 1.4 mg/m2 of the~     investigational product intravenously in 2-5 min on day 1 and day 8 of every 21-day cycle. In~     case of the progression of disease, unacceptable toxicity, withdrawal of the consent, or~     judgment by investigator that the treatment needs to be stopped, the treatment of~     investigational product is stopped, and treatment termination assessment is performed within~     30 days from the last treatment.~   "
122693|NCT01961531|"~     To evaluate safety of 5 fraction accelerated partial brest irradiation in more convenient 5~     fraction schedule.~   "
122694|NCT01961518|"~     The purpose of this study is to identify patients with Morquio syndrome type A (MPS IVA) and~     Maroteaux-Lamy syndrome (MPS VI) who may have been missed or misdiagnosed due to atypical~     clinical features, a milder course, and/or negative urine screening. We will recruit~     participants who have certain hip and/or joint problems that could potentially be caused by~     one of these two genetic conditions through a chart review process conducted at Shriners~     Hospital for Children in Greenville, SC. Diagnostic testing will be performed for each~     participant to determine if he or she is affected by one of these two conditions. Results~     will be disclosed to all participants and their legal guardians, and appropriate follow up~     will be recommended for those who are found to have abnormal results.~   "
122695|NCT01961505|"~     Rheumatoid Arthritis (RA) is an autoimmune disease that results in a chronic inflammatory~     disorder that may affect many synovial joints, and may cause serious disability. It has been~     confirmed that Tripterygium wilfordii Hook F has effects of anti-inflammatory,~     immunosuppressive and cartilage protection. This is a prospective randomized controlled study~     to evaluated the efficacy and safety of external application with compound Tripterygium~     wilfordii Hook F in treating of patients with rheumatoid arthritis (RA).~   "
122696|NCT01961492|"~     The purpose of this study is to find out whether a single fecal microbiota transplantation is~     an effective and safe treatment as an adjunct to standard therapy in patients with ulcerative~     colitis.~   "
122697|NCT01961479|"~     The purpose of this study is to determine whether an internet-based CBT (iCBT) is effective~     in reducing the impairment caused by premenstrual symptoms.~   "
122698|NCT01961466|"~     This study is based on the analysis of psychological and social questionnaires filled in by~     diabetic patients whose glycemic balance will be assessed by measuring blood levels of~     glycated haemoglobin. The aim is to compare glycemic balance by measuring HbA1c in diabetic~     patients (type 1 and 2) according to whether they have a Type A or B psychosomatic profile~     evaluated by the Bortner self-questionnaire.~   "
122699|NCT01961453|"~     The purpose of this research study is to test whether treatment with isosorbide mononitrate~     will improve left ventricular hypertrophy (thickening) which puts people at risk for~     developing heart failure. Once it develops, heart failure is a very serious condition and~     thus it is important to find ways to prevent it from happening. The investigators have~     reasons to believe that dilating the blood vessels with this specific medication will improve~     the thickening of the heart, which increases the risk of heart failure.~   "
122700|NCT01961440|"~     This research is to establish a simple and practical system to predict the prognosis of sever~     hepatitis B.Seven factors (level of serum total bilirubin, prothrombin time, severity of~     hepatic encephalopathy, hepatorenal syndrome,ascites ,infection and size of liver) which were~     easier to evaluate and more influential， were included to establish a prognosis scoring~     system．The scorings of a new score system and MELD were graded at the same time in the~     patients with sever hepatitis B. And then the distribution figures of survival rates and~     mortality rates were done according to the scores from low to high. The features of~     distribution figures of two score system in survival rates and mortality rates and~     significances of clinical application in certain score were interpreted.~   "
122701|NCT01961427|"~     It was shown by some researchers that dietary nitrate such as beet root juice can lower~     oxygen consumption in men and act as a performance enhancing supplement.~      It was not shown, what the optimal dosage is and if there is any difference in oxygen~     consumption comparing beet root juice and inorganic nitrate.~      Therefore, the aim of the study is to conduct a study ingesting different sodium nitrate and~     beet root juice dosages. We would measure nitrate and nitrite concentrations in the blood at~     different time points and the subjects have to perform an exercise test measuring oxygen~     consumption 3 hours after the ingestion of nitrate.~   "
122704|NCT01961388|"~     The study is designed as non interventional to collect data on the effectiveness of acarbose~     and metformin monotherapy, respectively, in terms of change from baseline in post prandial~     blood glucose level at the end of 16 weeks in drug-naïve type 2 diabetic patients within each~     carbohydrates consumption subgroup under real-life treatment condition in large sample of~     type-2 diabetes patients in India. The study will begin after the study approval by ethics~     committee.All drug naïve patients in whom decision to administer acarbose or metformin~     monotherapy for type 2 diabetes management has been made will be included in study after~     taking the informed consent.Patients will be observed for up to 16 weeks (2 weeks).The study~     involves general examination of patients, collection of data like history of disease,~     concomitant medication, drug dose , 24 hr dietary recall etc. The study is planned to enroll~     12250 subjects from multiple study centers spread across India. The study data will be~     analyzed with appropriate statistical methods.~   "
122705|NCT01961375|"~     The study is designed as non interventional to observe the continuation rate and the patient~     satisfaction in women who have a LNG-IUS (Levonorgestrel releasing Intrauterine system)~     inserted for contraception over the period of 12 months under real life condition in~     India.The study will begin after the study approval by ethics committee.All Indian women aged~     between 18-49 years who are initiating LNG IUS therapy for contraception will be included in~     study after taking the informed consent.Patients will be observed for upto 12 months.The~     study involves general examination of patients, collection of data like medical history,~     previous contraceptive use,concomitant medication etc.The study is planned to enroll 600~     subjects from multiple study centers spread across India. The study data will be analyzed~     with appropriate statistical methods.~   "
122706|NCT01961362|"~     To enhance understanding of supplemental oxygen—its utility in and adoption by patients with~     pulmonary fibrosis—by examining how patients perceive it and by determining how perceptions~     and patient-centered outcome measures change from before to after supplemental oxygen is~     prescribed.~   "
122707|NCT01961349|"~     This study is designed as a multi-centre, randomised, parallel-group, placebo-controlled,~     phase III confirmatory study. The study will be partially double-blinded: the comparison~     between Group 1 (placebo group) and Group 2 (ICI35,868 without EES0000645/A) will be carried~     out in double-blind, but the comparison between Group 1 (placebo group) and Group 3~     (ICI35,868 with EES0000645/A) will be carried out in single-blind.~      The efficacy and safety of ICI35,868 with and without EES0000645/A for the sedation to be~     moderate for a diagnostic gastrointestinal endoscopy and gastrointestinal endoscopic~     polypectomy will be evaluated.~   "
122708|NCT01961336|"~     Ιt has been suggested that the accumulation of androgens in the micro milieu of the primate~     ovary, plays a critical role in early follicular development and granulosa cell~     proliferation. Increased intraovarian concentration of androgens seems to augment follicle~     stimulating hormone (FSH) receptor expression in granulosa cells and thus, potentially~     leading to enhanced responsiveness of ovaries to FSH. In addition, androgen excess has been~     shown to stimulate early stages of follicular growth and increase the number of pre-antral~     and antral follicles.~      On the basis of these data, it has been hypothesized that increasing androgen concentration~     in the ovarian micro milieu in poorly responding patients might lead to an increase in the~     number and the maturity of oocytes after ovarian stimulation for IVF. Hence, recent efforts~     have been focused on the potential benefit of androgen administration in the probability of~     pregnancy in poor responders undergoing ovarian stimulation for IVF.~      Pretreatment with transdermal testosterone has been suggested as a safe and effective way of~     increasing the intraovarian androgen concentration. Recently, published, randomized control~     trials (RCTs) have evaluated transdermal testosterone in poor responders undergoing ovarian~     stimulation for IVF, with inconclusive results.~      In view of the conflicting or inconclusive data regarding the efficacy of the proposed~     intervention, this study will attempt to explore the role of transdermal testosterone~     pretreatment in poor responders undergoing IVF through a properly designed RCT. The lack of a~     universal definition of poor responders has been identified previously and recently, in an~     attempt to address this issue, universal criteria for the definition of poor ovarian response~     have been proposed following a consensus meeting in Bologna. In the present study, the~     Bologna criteria will be used on the contrary to previous studies.~      Despite the advancement in assisted reproduction technologies, poor ovarian response (POR) is~     still considered to be one of the most challenging tasks in reproductive medicine. Poor~     ovarian response is considered to be an inadequate response to ovarian stimulation, defined~     usually by a low number of oocytes retrieved or a low number of developing follicles in a~     previous or in the running, respectively, in vitro fertilization (IVF) cycle. Given the~     severely diminished probability of pregnancy after IVF in these patients, the identification~     of an indisputably efficacious treatment, such as testosterone pretreatment, would be a~     promising alternative for poor responders undergoing IVF.~   "
122709|NCT01961323|"~     To investigate whether treatment with Nebivolol in subjects with high blood pressure and~     abnormal filling of left ventricle (LVDD) improves exercise time by improving Left~     Ventricular deformation and filling.~   "
122710|NCT01961310|"~     The main objective of this study is to compare the intestinal microbiota in newly diagnosed~     rheumatoid arthritis (RA) with that from individuals without RA.~      The first analysis will compare the proportion of filamentous bacteria in the intestinal~     microbiota between the two groups.~   "
122711|NCT01961297|"~     The proposed research aims to determine brain abnormalities in patients with spasmodic~     dysphonia (SD) and voice tremor (VT) as the basis for characterization of central mechanisms~     underlying symptom improvement following the use of sodium oxybate, a novel oral medication~     for the treatment of ethanol-responsive dystonia. The proposed research is relevant to public~     health because the elucidation of disorder-specific mechanistic aspects of brain organization~     in SD vs. SD/VT is ultimately expected to lead to establishment of enhanced criteria for~     clinical management of these disorders, including differential diagnosis and treatment. Thus,~     the proposed research is relevant to the part of NIH's mission that pertains to developing~     fundamental knowledge that will help to reduce the burdens of human disability.~   "
122718|NCT01961206|"~     Escherichia coli is the leading cause of community-onset gram-negative bloodstream~     infections. There has been a dramatic increase in the prevalence of extended-spectrum~     b-lactamases producing E. coli and K.pneumoniae in the community, which was considered to be~     exclusively a nosocomial pathogen in recent years. As a result, the treatment options for~     community-onset infections due to ESBL-producing E. coli or K.pneumoniae are limited and the~     initial empirical therapy is often ineffective and associated with increased mortality.~     Although there were some reports of the risk factors of community-onset ESBL producing E.~     coli in Spain, Korea, and Canada, few empirical data were available about China. Therefore,~     the investigators aim was to investigate the epidemiology, risk factors, and the hospital~     outcomes for patients with community-onset bacteremia caused by ESBL producing E. coli or~     K.pneumoniae in China.~   "
122719|NCT01961193|"~     Study Rationale:~      The insertion of a bandage contact lens or punctal plug in a defined group of patients~     admitted to the ICU may be more effective than standard care in decreasing the incidence of~     corneal injuries.~      Study Objectives:~        1. To document the effect of a contact bandage lens and punctal plug in preventing corneal~          injuries in critically ill patients admitted to the ICU.~        2. To assess the safety of a contact bandage lens and punctal plug in critically ill~          patients.~   "
122712|NCT01961284|"~     Dental implants are used for replacing missing teeth. Placing dental implants is limited by~     the presence of adequate bone volume permitting their anchorage. In order to solve this~     problem several bone augmentation procedures have been developed. In principle the missing~     bone is taken from a donor site (for example the hip), transplanted where needed and then~     implants are placed. Sometimes, major bone grafting operations have to be undertaken under~     general anaesthesia requiring patients to be hospitalised for a few days. Some degree of~     morbidity related to the donor site must be expected, though more recently bone substitutes~     are used to minimize morbidity, and 2 to 3 surgical interventions may be needed before the~     implants can be functionally used. Sometimes patients have to wait more than 1 year before a~     prosthesis can be fixed to the implants and the total cost of the treatment is high. At the~     beginning of the 1990s a long screwshaped implant was developed by Professor PI Brånemark as~     an alternative to bone augmentation procedures: the zygomatic implant. Zygomatic implants are~     generally inserted through the palate to engage the body of the cheek bone. One to three~     zygomatic implants can be inserted through the posterior palate to engage the body of each~     cheek bone. The potential main advantages of zygomatic implants could be that bone grafting~     may not be needed and a fixed prosthesis could be fitted the same day of their placement.~     Despite that zygomatic implants have been used for more than 20 years, their effectiveness~     has never been compared with conventional dental implants in augmented maxillae. The aim of~     the project is to compare the longtermclinical outcome of fullarch upper jaw bridges~     supported by zygomatic implants versus conventional implants placed in augmented bone in the~     palate.~   "
122713|NCT01961271|"~     The purpose of this study is to assess the efficacy of the buprenorphine transdermal patch~     (Norspan® or Sovenor® transdermal patch) in patients with chronic non-malignant pain of~     moderate to severe intensity due to osteoarthritis, rheumatoid arthritis, lower back pain and~     joint/muscle pain, who are not adequately responding to non-opioid painkillers.~   "
122714|NCT01961258|"~     SEVERE ASTHMA IN THE COMMUNITY-~      BACKGROUND Severe asthma is a common problem. In the world approximately 300 million people~     have asthma but it is estimated that only 5% of these patients have severe asthma. Although~     severe asthma comprises a small fraction of the entire asthmatic population its share in~     the total economic burden of asthma is 80 percent. In Israel the prevalence of asthma among~     adult patients is about 5-6% but the prevalence of severe asthma is unknown.~      The definition of severe asthma has been changed during the years. Most recently in 2009 the~     WHO agreed on a unified definition of severe asthma that would fit countries of different~     socioeconomic development [1]. Severe asthma includes now 3 different groups: group one~     untreated severe asthma, group two difficult to treat severe asthma and group three~     treatment-resistant severe asthma. As all asthmatic patients in Israel have easy access to~     medical care, the current study will deal with the last two groups (difficult to treat~     asthma and treatment resistant asthma).~      AIMS Primary endpoints:~        1. To identify the prevalence of severe asthma in the community according to the WHO~          definition of group two & three.~        2. To assess whether anti-IgE therapy (Omalizumab), was considered in these groups of~          severe asthma.~      Secondary endpoints:~        1. To assess factors involved in difficult to treat asthma according to the WHO~          definition. Factors as patient compliance, presence of co-morbidities, symptoms of~          untreated potential asthma triggers including GE reflux, post nasal drip/atopic~          rhino-sinusitis, and intervening medications including NSAID and beta-blockers.~        2. To asses the level of asthma control, level of patient follow-up care including asthma~          specialist visits, periodic PFT's and asthma education.~        3. To assess the fraction of patients with severe asthma that is eligible to anti-IgE~          therapy according to the indications of the Israeli Ministry of Health (proven asthma,~          uncontrolled by high dose of combined ICS+LABA inhaler therapy + at least 2 courses of~          systemic corticosteroids in the last year + proven atopy to at least one perennial~          aeroallergen + IgE level of 30-1,500 IU/ml)~      DESIGN A prospective non-blinded non-randomized observation study among the population~     insured by Clalit Medical Services (CMS) in the Sharon- Shomron Medical District in Israel.~   "
122715|NCT01961245|"~     It has been shown, that in patients with very severe chronic obstructive pulmonary disease~     (COPD) the additional use of non-invasive ventilation during pulmonary rehabilitation (PR)~     may enhance the benefits of PR. It is assumed that the non-invasive ventilation techniques~     provides a better recovery of the respiratory pump during the night. If non-invasive~     ventilation also decreases the metabolic demands during night is unknown and is aim of this~     study. During a 3 week inpatient pulmonary rehabilitation program a total of 85 patients with~     chronic obstructive pulmonary disease stage IV will be recruited for this study. There will~     be a 4:1 distribution into 2 groups. 68 patients with an indication for the use of a~     non-invasive ventilation will be involved in the intervention group where non-invasive~     ventilation will be initialized. 17 patients with chronic obstructive pulmonary disease stage~     IV without an indication for the use of non-invasive ventilation will be involved in a~     control group to detect the changes in nocturnal energy expenditure produced by pulmonary~     rehabilitation alone. All outcome measurements will be performed during day 1-3 and will be~     repeated after 12 days (with or without non-invasive ventilation) at day 15-17 of the~     pulmonary rehabilitation program.~      A sub-trial of this study is to validate night movement accuracy of the Dynaport activity~     monitor with the observations made by a night-vision camera in the sleep lab. This will be~     performed in study participants as well as in healthy volunteers.~   "
122716|NCT01961232|"~     The investigators are testing whether the addition of Pulmonary Hypertension-related~     biomarkers, measured across the pulmonary circulation, to the standard hemodynamic evaluation~     for Pulmonary Hypertension will lead to more informed choices of Pulmonary Hypertension~     therapy and improved patient outcomes.~   "
122717|NCT01961219|"~     Shoulder pain is one of the most common causes of musculoskeletal disability in the adult~     population. Adhesive capsulitis is one of a multitude of reasons that can cause shoulder pain~     and dysfunction. It is a painful and disabling condition that can cause frustration for~     patients and caregivers due to slow recovery time. It is important to meticulously diagnose~     the source of the symptoms. Adhesive capsulitis is treatment by non-operative therapies such~     as physical therapy, exercise, steroids & pain medications. For some patients a quicker~     return to function is necessary; in th is situation an operative treatment is an option. This~     study will compare two surgical techniques for adhesive capsulitis.~      Purpose~        1. To directly compare outcomes of patients with adhesive capsulitis who have failed pain~          management and failed improvement in range of motion after at least 3 months of~          supervised, regimented conservative treatment and have subsequently been randomized to~          either closed manipulation under anesthesia or arthroscopic capsular release.~        2. To blind both patient and assessing physician/nurse study coordinator to the treatment~          that was received for the duration of the study. This will reduce the effect of any~          potential bias on the results as much as possible.~        3. To collect outcome data, both subjectively from the patient using proven outcome~          measures, and objectively from regularly spaced follow up visits with blinded assessors.~        4. To collect and comment on data from the two treatment groups regarding duration of~          post-operative narcotic use, duration of post-operative physical therapy required,~          post-operative pain levels, and elapsed time until back to work/activity~          post-operatively.~   "
122722|NCT01961154|"~     Background:~      The most common asthma drugs, namely inhaled glucocorticoids (ICS) and long-acting beta-2~     sympathomimetic drugs (LABA) carry a risk of adverse effects, some of which being potentially~     severe. Therefore, current guidelines for asthma management recommend that, after a period of~     symptom control, a reduction of the dose and cessation of the ICSs and LABAs should be~     attempted. However, reduction in asthma medications sometimes leads to an exacerbation of~     asthma. Therefore both physicians and asthmatics are often reluctant to reduce or stop asthma~     medications and asthma over-medication often occurs. A test that could identify those~     asthmatics who probably would tolerate asthma medication reduction would be useful.~      Objectives:~        1. To investigate whether airway responsiveness to hypertonic saline can predict the~          outcome of asthma treatment reduction in subjects with controlled asthma.~        2. To get an estimate about how large a proportion of Finnish asthmatic patients use their~          medications with unnecessarily high doses or would even manage well without any asthma~          medications.~      Study hypothesis:~        1. Airway responsiveness to hypertonic saline can predict the outcome of asthma treatment~          reduction~        2. Most of the Finnish asthmatic patients use their medications with unnecessarily high~          doses~      Methods:~      This is a prospective study in which the physician responsible for the subject management and~     medications is blinded from the saline challenge results and the nurse performing the saline~     challenges is blinded from medications 70 asthmatic patients with both inhaled ICS and LABA~     will be recruited. Asthma must be well controlled (Juniper's Asthma Control Questionnaire~     score equal or less than 0.75 ).~      The asthma medications will be reduced in three steps, in six weeks' intervals, up to total~     cessation of asthma drugs or up to asthma exacerbation. The criteria for asthma exacerbation~     are strictly defined. First step: LABA will be discontinued. The ICS is continued. Second~     step: medium to high daily ICS dose is reduced to low daily dose. Third step: The low ICS~     dose will be stopped. Before each reduction, saline challenge will be performed. Asthma diary~     is kept throughout the study and the subjects will be provided a direct telephone number to a~     respiratory physician during all hours of day.~   "
122723|NCT01961141|"~     Historically, ultrasound has been unable to provide interpretable data from the lung~     parenchyma, mainly because of the high total ultrasound energy attenuation and scattering by~     the air in the lungs. Recently it has been shown that clear reproducible Doppler signals can~     be recorded from the lung parenchyma by means of a pulsed Doppler ultrasound system~     incorporating a special signal processing package (transthoracic parametric Doppler, TPD,~     EchoSense Ltd., Haifa, Israel). These lung Doppler signals (LDS) are in full synchrony with~     the cardiac cycle and can be obtained from the lungs, including areas remote from the heart~     and main pulmonary vessels. The LDS waves typically have peak velocities of up to 30 cm/s and~     are of relatively high power, making it possible to detect them despite the aforementioned~     attenuation by the air in the lungs. The LDS are thought to represent the radial wall~     movement of small pulmonary blood vessels, caused by pressure pulse waves of cardiac origin~     which propagate throughout the lung vasculature. The LDS may contain information of~     significant diagnostic and physiological value regarding the pulmonary parenchyma and~     vasculature, as well as the cardio-vascular system in general.~      Preliminary data from ongoing studies employing the TPD in chronic diseases such as CHF, COPD~     and pulmonary hypertension, show promise regarding the diagnostic potential of the lung~     Doppler signals (unpublished data). However, lung Doppler signals in acute disease states~     were not investigated so far. It is reasonable to speculate that the pathological processes~     underlying acute cardiovascular and pulmonary diseases will affect the LDS. Therefore, the~     TPD may have diagnostic potential in these conditions. For example, during acute pulmonary~     embolism a portion of the pulmonary vascular system is occluded; therefore it's reasonable to~     assume that the LDS will disappear in the affected area, enabling to confirm the diagnosis~     without using ionizing radiation (as in CT or lung scan). Another example is COPD~     exacerbation, during which there is usually air trapping in the lungs; thus, the LDS may be~     attenuated by the increase of air volume in the lungs.~   "
122724|NCT01961128|"~     This study is being done to see if the investigators can measure changes that occur in breast~     tissue when women at risk of developing breast cancer start an exercise program. The~     investigators are interested in studying this because research shows that women who exercise~     regularly are less likely to develop breast cancer, but there is not very much information~     explaining how exercise could affect breast cells in a way to prevent cancer from occurring.~     In this research study the investigators will use a research technique called breast random~     fine needle aspiration (RPFNA) to test breast cells for their shape and how they look. The~     investigators will look at breast cells before and after a participant takes part in an~     exercise program to see if the investigators are able to see any changes in breast cells that~     could have happened due to the exercise program. This research will help us to develop larger~     projects to see if exercise programs could be helpful in preventing breast cancer.~   "
122725|NCT01961115|"~     This pilot phase II trial studies how well epacadostat and vaccine therapy work in treating~     patients with stage III-IV melanoma. Epacadostat may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Vaccines made from peptides and antigens~     may help the body build an effective immune response to kill tumor cells. Giving epacadostat~     with vaccine therapy may be an effective treatment for advanced melanoma.~   "
122726|NCT01961102|"~     It is to be achieved that in postmenopausal women through the combination of Hysteroscopy and~     intraoperative rapid section a positive predictive value (PPV) regarding the objective~     illness like endometrial cancer or adenomatous hyperplasia of 100% so as a negative~     predictive value (NPV) of 99%.~   "
122727|NCT01961089|"~     Study question: How does the new GALILEI Lens Professional compare to predicate devices?~     Study hypothesis: The GALILEI Lens Professional achieves a better precision in the~     postoperative, calculated target refraction with cataract surgeries than predicate devices,~     and it is more versatile in the measurable parameters as well as more user-friendly.~   "
122728|NCT01961076|"~     In this clinical cross-over study, we will compare the efficacy of different oral nutrition~     regimens for night-time glucose control in adult GSD 1 patients. Three different over-night~     nutrition regimens (=interventions) will be compared in each patient sequentially, (1)~     uncooked corn starch (UCSS, Maizena), (2) modified corn-starch, (3) other carbohydrate~     (starch) containing meal. During each intervention, glucose profiles will be continuously~     monitored by continuous glucose monitoring (CGMS). The duration of each intervention is 3d~     (mimimum) to 6d (maximum), depending on the quality of night-time glucose control and the~     technical quality of glucose sensor readings. Between the interventions, the patients follow~     their normal prescribed diet.~   "
122729|NCT01961063|"~     This pilot clinical trial studies gene therapy after frontline chemotherapy in treating~     patients with acquired immune deficiency syndrome (AIDS)-related non-Hodgkin lymphoma (NHL).~     Placing genes for anti-human immunodeficiency virus (HIV) ribonucleic acid (RNA) into~     stem/progenitor cells may make the body build an immune response to AIDS. Giving the~     chemotherapy drug busulfan before gene therapy can help gene-modified cells engraft and work~     better.~   "
122730|NCT01961050|"~     The purpose of this study is to evaluate an intervention aimed at reducing risk for~     alcohol-exposed pregnancies and preventing Fetal Alcohol Spectrum Disorders in Russian~     children. The study will determine whether physicians, trained in a dual-focused brief~     motivational intervention and monitored for performance, can foster greater change in~     knowledge, health beliefs, alcohol use, and alcohol-exposed pregnancy risk in Russian women~     who are at risk than standard care.~   "
123230|NCT01954498|"~     The investigators are testing the hypothesis that two ounces of whole-shelled walnuts/day~     added to the diet of men seeking care for infertility will beneficially affect sperm~     parameters and fertility. The investigators will compare the walnut intervention to the~     commonly suggested recommendation of adding an OTC multivitamin supplement to the diet.~   "
122731|NCT01961037|"~     Falls are the leading cause of death and injuries in adults over age 65 both nationally and~     in West Virginia. Rurality, age, physical inactivity, and chronic conditions, such as~     arthritis, are strong risk factors for falls in this population. West Virginia has a higher~     than average fall rate, the second oldest population, the greatest proportion of inactive~     adults, and the second highest prevalence of arthritis in the US. Thus, older adults in rural~     West Virginia are at high risk for falls and in great need of public health fall prevention~     programs. The Tai Chi: Moving for Better Balance (MFBB) program is a community-based,~     fall-prevention exercise program for older adults. A waiver of informed consent will be~     requested to conduct the telephone screenings to determine study eligibility. We will enroll~     up to 300 people in classes to be held at 20 churches in West Virginia. Classes will be held~     twice per week for 16 weeks and taught by certified MFBB instructors. Participants will be~     interviewed by telephone, have a brief physical function ability exam, and complete a~     questionnaire before starting the exercise class, at the end of the class, and 4 months~     later. The study is being conducted to answer the following questions: 1) What are the~     functional improvements of older adults who participate in a 16-week MFBB program; 2) What is~     the rate of falls for those adults; 3) What is the rate and severity of those fall-related~     injuries of the MFBB participants? The purpose of the study is to: 1) implement a 16-week~     intervention of MFBB with a 16-week follow-up, in older adults in churches in rural West~     Virginia; 2) describe functional and fall/injury outcomes. Ultimately, we will translate an~     efficacious and effective fall-prevention intervention into a new setting.~   "
122732|NCT01961024|"~     In thise study, we aim to determine the effect of meal fat on VLDL-TG kinetics in type 2~     diabetic and healthy subjects matched for BMI in order to elucidate the potential~     pathophysiological differences in VLDL-TG FA channeling towards oxidation and storage in~     abdominal and leg subcutaneous adipose tissue. Specifically, we want to measure, by way of~     fat and muscle biopsies, the quantitative postprandial storage of VLDL-TG FA's in skeletal~     muscle and adipose tissue in relation to a series of tissue specific proteins and enzymes~     that might be involved in regulating skeletal muscle and adipose tissue FA storage.~   "
122733|NCT01961011|"~     Carpal tunnel release is a well accepted treatment for median nerve compression at the wrist.~     With a prevalence of 50 per 1000, it is the most common compressive neuropathy. With a number~     of anatomic as well as systemic factors playing a role in the development of carpal tunnel~     syndrome, it is not surprising that there is a high incidence of bilaterality with this~     disease. Padua et al. reported that 87% of 266 consecutive cases had signs and symptoms of~     carpal tunnel syndrome in their contralateral hand.~      In patients who have bilateral carpal tunnel syndrome that has not responded to conservative~     treatment, surgical release is indicated. In such cases, a decision must be made whether to~     offer bilateral simultaneous surgical release or to stage the two affected hands to allow~     time to recover from each.~      The purpose of this study is to determine the differences in short term disability between~     having bilateral vs unilateral carpal tunnel release. With better understanding of the way in~     which patients are impaired, better recommendations may be made on which patients to indicate~     for simultaneous bilateral procedures and who would benefit from staging procedures, allowing~     the patient to recover from one hand prior to proceeding to surgery on the other hand.~   "
122734|NCT01960998|"~     Many men develop urine leakage after prostate cancer surgery. Usually it is temporary, but~     pelvic floor muscle training and exercise (including urine control strategies) have been~     shown to reduce the time to regaining urine control. This study tests an evidence-based,~     pelvic floor muscle training program that has been adapted to telehealth format and pilot~     tested in a VA-funded pilot/developmental trial. Training is begun 1-4 weeks before surgery~     and continued 6 months after surgery. Content is accessed on a secure website in daily~     10-minute sessions which transition to weekly sessions for post-operative months 3-6. In the~     investigators' pilot study, Veterans reported that they appreciated receiving the training in~     the privacy of their homes, enjoyed the interactive style of the learning experience, and~     felt better prepared to deal with urine leakage and empowered with new knowledge and skills~     to help themselves. Content for both control and treatment groups includes general~     information about prostate cancer; perioperative care; wetness, odor and skin care~     management. The treatment group will ALSO receive pelvic floor muscle training and bladder~     control strategies. Outcomes are measured with brief validated questions administered by the~     telehealth platform, and again at 9 and 12 months by mailed questionnaire or the telehealth~     platform.~   "
122735|NCT01960985|"~     Verifying the efficiency of motor training associated with visual and auditory cues on the~     balance, and postural anticipatory and compensatory adjustments of patients with Parkinson's~     Disease (PD), for prevent fall rate in people with PD. It is a single blinded, randomized~     clinical trial performed at Center of Research of the courses of Speech Therapy, Physical~     Therapy and Occupational Therapy of São Paulo University.~   "
122736|NCT01960972|"~     This protocol aims to implement, using a stepped wedge trial design, a population-level~     intervention to replace high-sodium salt for a salt substitute (low-sodium, high-potassium~     salt) to reduce blood pressure levels among adults aged 18 years and over of the semi-urban~     area of Tumbes.~      We hypothesize that participants aged 18 years and over from villages receiving a salt~     substitute will have lower blood pressure compared to control villages.~   "
122737|NCT01960946|"~     This study will investigate if Modified Citrus Pectin (MCP) can help people with high blood~     pressure. MCP is a dietary supplement that is derived from plants, and therefore is not~     subject to approval by the U.S. Food and Drug Administration (FDA). However, MCP has been~     deemed as 'generally regarded as safe' by the FDA.~      This study will examine whether Modified Citrus Pectin (MCP) can help people with high blood~     pressure. The study will help understand how MCP may affect the risk for heart disease in~     patients with high blood pressure.~   "
122738|NCT01960933|"~     In patients with ST-elevation myocardial infarction (STEMI) the primary treatment is acute~     angioplasty of the acute occlusion (culprit lesion). In STEMI patients with multi vessel~     disease (MVD) no evidence based treatment of the non-culprit lesions exists. We aim to~     provide evidence as to whether full revascularization or revascularization of the culprit~     lesion only provides the best prognosis for the patient.~   "
125722|NCT01921868|"~     The purpose of this study is to learn how treatment with acetyl-L-carnitine (ALCAR) will~     affect the hearts of patients with Friedreich's Ataxia as well as how it may affect other~     symptoms of Friedreich's Ataxia such as difficulties with balance, walking, or upper arm~     function.~   "
122740|NCT01960907|"~     The CHROMED project focuses its investigation on the applicability of an integrated solution~     for a pathological condition which: a) is very prevalent in ageing patients and b) severely~     impairs quality of life: COPD with other typical comorbidities such as congestive heart~     failure and sleep disordered breathing. A specific ICT platform in combination with a set of~     innovative devices will be used to collect and process useful clinical data at the patient's~     home and used to optimize their medical treatment. To evaluate the impact of this solution,~     an international multi-centric randomized control trial will be implemented in five European~     regions: United Kingdom, Sweden, Estonia, Spain and Slovenia, representing different social~     and organizational contexts in Europe.~   "
122741|NCT01960894|"~     If the heart fails to pump a sufficient amount of blood, it is crucial to know why in order~     to provide the best treatment. Pressure-volume analysis is the gold standard for evaluating~     the heart's pumping function. Unfortunately, current techniques are invasive, so most~     patients will not get this examination. By combining the strengths of echo-Doppler~     ultrasound, blood pressure monitoring and biomedical computing, the investigators aim to~     develop a non-invasive method for pressure-volume analysis, extending its applicability to~     more patients and settings.~   "
122742|NCT01960881|"~     Canadian Real Life Evaluation of the Effect of Diet and Exercise in Prostate Cancer Patients~     Managed with Lupron.~   "
122743|NCT01960868|"~     Liver transplantation is the last surgical treatment for patients with acute or chronic liver~     disease. Transplantation therapies technics are in constant evolution. It allows an~     increasing survivals rates and time to come back to daily activities. The postoperative~     treatment after abdominal surgery as Liver Transplantation (LT) is usually performed in~     Intensive Care Unit (ICU).This postoperative phase is one of the most important steps~     regarding the involvement of the rehabilitation of the patient (Rongies 2005). Physical~     abilities transplantation are likely to be important in the postoperative. It appears that~     pre-transplant subjects have a weakened muscle potential, they will increase it significantly~     in the months after transplantation with a rehabilitation program adapted (Beyer 1999).~     Length of stay in ICU depends on surgery complications. Inactivity induced by sedation and~     ICU length of stay are major factor for increasing complications as respiratory disorders and~     muscle weakness. Several studies have reported feasibility and safety an early mobility~     program in ICU, especially regarding the length of stay decrease (Bailey 2007; Morris 2008;~     Schweickret 2009, Needham 2010; Bourdin 2010) These early mobility programs encompass muscle~     strength assessment, passive range of motion, active mobility, sitting on the edge of bed,~     standing and walking, which would be related to the primary disease of LT (Rongies 2008). The~     assessment of the strength for ICU patient is feasible and reproducible with the Medical~     Research Council score (MRC score). The MRC score consists in an assessment of three muscle~     groups of upper and lower limbs. Sitting positions and verticalization are included in~     programs begun as soon as possible after surgery evaluation of the response level to verbal~     stimulation and physical abilities (Gosselink 2011). The skills of the physiotherapist are~     established in legal texts making him a key in the assessment and management of these~     patients on musculoskeletal and respiratory domains.~      The purpose of this study is to validate data feasibility and tolerance. Another aim is also~     to assess the length of stay in ICU, of early mobility and physical program, started in the~     postoperative period in a population of patients with liver transplantation, during their~     stay in ICU of Prof. Albanese. Thus, we decided to carry out a parallel study, open,~     randomized monocentric comparing two groups of patient liver transplanted. The control group~     will receive the standard treatment used in the ICU and the experimental group will receive a~     protocol of early mobilization according to data from recent literature on the subject. The~     study is scheduled to last over one year and included patients will receive physical therapy~     on five days a week with a frequency of one to several times per day depending on the~     clinical requirements or conditions of the study.~   "
122744|NCT01960855|"~     This is a multi center, randomized, double-blind, placebo-controlled phase 2 study in~     subjects with moderately to severely active rheumatoid arthritis on background methotrexate~     who have failed anti-Tumor Necrosis Factor (TNF) biologic therapy.~   "
122745|NCT01960842|"~     The primary objective of this study is to measure the efficacy of ABT-SLV187 in subjects with~     advanced Parkinson's disease.~   "
122746|NCT01960829|"~     This is a single-armed, open-labeled and single-centered study of everolimus in selective~     patients with metastatic melanoma for evaluation of the efficacy and safety. The study~     objective is to evaluate efficacy profile of everolimus.~      The patients who comply with the inclusion and exclusion criteria will be enrolled. The~     estimated recruiting duration is 18 months. Everolimus will be given in the dose of 10 mg~     orally each day at lease 6 months unless disease progression or intolerance. The follow-up is~     till death(at least 1 year).~   "
122747|NCT01960816|"~     Pilot Study of the Aerin Medical Wand used for Improvement in Nasal Breathing~   "
122748|NCT01960803|"~     The overall objective of this study is to determine the feasibility and tolerability of~     single dose Intraoperative Electron Radiation Treatment (IOERT) as definitive therapy when~     administered at the time of breast conserving surgery for patients with early stage breast~     cancer.~   "
122749|NCT01960790|"~     This investigation will be conducted to obtain the following information regarding the use of~     Adalimumab 40mg Syringe 0.8mL for Subcutaneous Injection in patients with Intestinal Behcet's~     Disease.~        1. Incidence and conditions of occurrence of adverse reactions in clinical practice~        2. Factors likely to affect the safety and effectiveness~   "
122750|NCT01960777|"~     The objective of this study is to evaluate chronic pain after inguinal hernia repair~     involving mesh placement with the Onstep-technique compared to mesh placement using a~     laparoscopic approach. The study hypothesis is that an even or smaller proportions of~     patients operated the Onstep technique will have chronic pain that impairs daily function.~   "
122751|NCT01960764|"~     Unlike healthy control skin, the skin of patients with atopic dermatitis (AD) is frequently~     colonized by Staphylococcus aureus (S. aureus), putting these patients at increased risk of~     S. aureus skin infections. In addition, research in the investigator's lab has shown that~     these patients have fewer protective antimicrobial Staphylococcal species such as~     Staphylococcal epidermidis (S. epidermidis) known to produce antimicrobial peptides that play~     a role in protecting the skin from invading pathogens. In this study, the investigator will~     attempt to decrease S. aureus colonization and increase colonization by protective Staph~     species. First the investigator will culture the bacteria on subjects' lesional AD skin. The~     investigator will selectively grow the subject's antimicrobial Staph colonies and place them~     into a base moisturizer. The moisturizer plus bacteria will be applied to both of the~     subject's arms. Prior to applying this, though, one arm will first be pre-treated with an~     antimicrobial regiment of Dial liquid antibacterial soap and alcohol. We will then compare~     the abundance of antimicrobial Staph species on each subject's arms 24 hours later to~     determine whether the pre-treatment regimen increased survival of the transplanted~     antimicrobial Staph species. The investigator expects that the arm pre-treated with the~     antimicrobial regimen will have more antimicrobial Staph species at this time point.~   "
123316|NCT01953367|"~     This study will investigate the bioequivalence and compare the safety profiles following~     inhalation of Vantobra to TOBI nebulizer solution in healthy subjects.~      Bioequivalence will be investigated based on the pharmacokinetic plasma profiles of Vantobra~     nebulizer solution compared to TOBI nebulizer solution.~   "
122752|NCT01960751|"~     Context: Studies that address specifically the neurocognitive consequences that can be caused~     by low-dose radiation receiving during the childhood have still to be performed. In this~     issue, we focus on an investigation with patients who have received radiotherapy for a benign~     tumor (skin hemangioma), in France.~      Patients and methods: More than 8300 children with a skin hemangioma were treated at Gustave~     Roussy (Île-de-France) from 1941 to 1973 and a number of them have received radiotherapy.~     These patients have been treated and followed by Gustave Roussy, so their clinical records~     can be tracked with great accuracy and the ionizing radiation dose to the brain have been~     estimated. From this patient cohort, the aim is to evaluate neurocognitive dysfunction or~     disorder that can be caused by low-dose radiation to the brain (less than one Gray (Gy)). A~     total of 150 patients is expected. They will be contacted by letter to explain the purpose~     and methods of carrying out tests. Two groups will be analysed according to the received~     ionizing radiation dose to the brain during the radiotherapy (exposed: 0.05 to 1 Gy, vs~     unexposed: less than 0.05 Gy). Tests exploring several cognitive functions (memory,~     arithmetic, orientation, etc.) will be used.~      Expected results: We expect to describe the potential neurocognitive dysfunction or disorder~     and to identify risk factors and brain structures whose lesions are responsible for the~     neurocognitive dysfunction or disorder.~      A therapeutic treatment will be proposed in the eventuality of screening of a neurocognitive~     dysfunction or disorder.~   "
122753|NCT01960738|"~     To evaluate the efficacy of using a pre-dive checklist to prevent the incidence of diving~     mishaps in recreational divers.~   "
122754|NCT01960725|"~     This is a pilot study to assess the safety and immunogenicity of pentavalent rotavirus~     vaccine (RV5) when administered according to an alternate dosing schedule (2-5 weeks, 2~     months and 4 months). In this interventional, open-label study, infants 2 through 5 weeks of~     age (14 to 41 days) will be enrolled and vaccinated with RV5 according to a 2-5 week, 2 and 4~     month schedule and infants 2 months of age (56 to 83 days) will be vaccinated according to~     the standard recommended schedule (2, 4, and 6 months of age). Sera will be obtained from~     subjects one month following the final dose of vaccine and will be assayed for anti-rotavirus~     IgA and rotavirus neutralizing antibody responses against the G1, G2, G3, G4 and P[8]~     serotypes. Post dose 3 G1 serum-neutralizing antibody (SNA) geometric mean titers (GMTs) will~     be compared between children receiving pentavalent rotavirus vaccine (RV5) according to the~     alternate dosing schedule versus the standard recommended schedule. Likewise, post dose 3 G2,~     G3, G4 and P[8] SNA and serum rotavirus IgA GMTs will be compared between children receiving~     RV5 according to the alternate dosing schedule and the standard recommended schedule. The~     safety and tolerability of RV5 in children receiving vaccine according to the alternate~     dosing schedule will be described.~   "
122755|NCT01960712|"~     Bile leakage after liver transection is treated by external drainage. The question addressed~     is whether downstream control by transpapillary stent insertion into distal bile duct can~     enhance healing.~   "
122756|NCT01960699|"~     Background: Cardiac arrest is a life-threatening event. Intensivists are challenged with an~     increasing number of patients with uncertain neurological outcome following cardiopulmonary~     resuscitation (CPR). The prognostic value of current biomarkers for neurophysiologic~     long-term outcome is limited.~      Hypothesis: We hypothesize that specific brain-derived tissue leakage proteins can be~     identified to reveal novel, more reliable prognostic biomarkers for good neurological~     outcome.~      Methods: This translational study (n=100) is a combination of a prospective basic science~     study intended to reduce the number of potential plasma biomarker candidates by proteomic~     shotgun analyses in brain tissue autopsy samples and plasma samples from resuscitated~     patients (n=10) and a prospective clinical validation study in a large study population~     (n=90) by high-throughput analyses. Selection of proteomic markers and signature estimation~     will be performed to discriminate patients with good and poor outcome.~      Clinical perspective: A structured proteomic analysis approach might identify the best marker~     out of all proteins liberated during cellular damage.~   "
122757|NCT01960686|"~     The purpose of this study is to evaluate the immunogenicity and safety of multiple~     formulations of an RSV-F protein nanoparticle vaccine, with aluminum, in healthy women of~     child-bearing age.~   "
122758|NCT01960673|"~     Generally, the laryngeal mask airway is not considered in the surgery which should be~     changing position in the perioperative period. The shape of the pharynx changes during the~     head and neck movement and there is probably also a change in the force transmitted to the~     cuff along the airway tube. Besides, there is evidence that supraglottic airway device can be~     displaced with rotation. In this article, the investigators want to discuss about that~     oropharyngeal leak pressure and sealing between the mask and vocal cord while changing head~     and neck position in perioperative period using different types of supraglottic airway~     device.~   "
122759|NCT01960660|"~     Supplementation with omega-3 fatty acids has been extensively researched and is known to~     provide healthful benefits for patients with a diversity of conditions and diseases. Not all~     omega-3 supplements are created equally however; some sources of omega-3 fatty acids are~     superior to others due to a greater bioavailability of omega-3 fatty acids than others,~     differences in source material, and processing techniques.~      The purpose of this study is to determine which marketed omega-3 product provided the~     greatest effect, as measured against its' label claim and recommended dosage.~   "
122760|NCT01960647|"~     The primary objective of this prospective, Randomized, Controlled, Multicentre, Open Study is~     to investigate the inhibition of restenosis by the Paclitaxel-eluting Percutaneous~     transluminal angioplasty (PTA) balloon Freeway versus PTA alone in the treatment of de-novo~     occluded, stenotic or reoccluded, restenotic superficial femoral (SFA) or popliteal arteries.~   "
122761|NCT01960634|"~     This is a multi-centric translational study with biological samples collection. The aim of~     this study is to validate a method to detect BRAFV600 in blood samples.~      Samples: Blood from patients with BRAFV600 metastatic melanoma collected following standard~     medical practice.~      The treatment is not the aim of the study. Patients can be treated either with specific or~     no-specific drug.~   "
122762|NCT01960621|"~     The investigators want to see whether the test drug in this research study,~     2-hydroxypropyl-beta-cyclodextrin (2HPBCD), might potentially be able to improve cough in~     healthy volunteers. The investigators are initially recruiting healthy volunteers such as who~     are free from any respiratory disease and not on any concurrent medication, so there are no~     confusing effects from pre-existing respiratory symptoms or disease, nor interaction of any~     medication with the test drug.~   "
122765|NCT01960582|"~     The rationale underlying this project is the fact that HA is a very common compensatory~     interven¬tion within municipality health care, undertaken to support an independent living in~     the own home. In addition, MD are frequently prescribed and used among HA clients in order to~     compensate for declined body functions. In spite of this, knowledge of their effects for the~     individual and the society is still scarce. In particular, systematic, evidence-based~     strategies based on clear-cut conceptual definitions and descriptions of procedures are~     lacking. Such strategies are crucial in order to evaluate the effects of HA and MD. In~     addition, longterm cost-effectiveness evaluations are crucial for policy implementation.~      The overarching aim is to investigate outcomes of HA on aspects of home and health for~     sub-groups of persons with disabilities.~      The specific aims are to:~        -  Investigate the effects of HA on home and health related outcomes, i.e. usability, fear~          of falling, activity/participation and health-related quality of life for different~          subgroups of persons, e.g. MD users and non MD-users~        -  Investigate the use of a new practice strategy for HA on home and health related~          outcomes for subgroups of persons with disabilities in terms of differences between~          municipalities~        -  Investigate societal level outcomes of HA and MD, i.e. costs and quality adjusted life~          years~        -  Gain a deeper understanding of the processes behind changes in outcomes We hypothesise~          that using a structure strategy for housing adaptation and mobility devices case~          management in ordinary practice in Swedish municipalities increase activity,~          participation, the usability of the home, and reduces societal costs.~   "
122766|NCT01960569|"~     Single centre ,Phase IV , interventional, The study includes :~      200 patients, 100 Patients will have Topical r-Hirudin (Thrombexx) and 100 patients will have~     placebo .~      The patients will be randomized to the active product (arm 1) or to placebo (arm 2).~      The study consists of 4 visits as the following :~        -  Visit 1 : on day 1 to check patient eligibility and also for randomization .~        -  Visit 2 : on day 4 to assess target parameters~        -  Visit 3 : on day 8 to assess target parameters~        -  Visit 4 : on day 16 to assess target parameters~   "
122767|NCT01960556|"~     Catheter associated blood stream infections (CA-BSI) remain a source of significant morbidity~     and mortality in adult and pediatric critical care units. While it has been established that~     CVL maintenance bundles are pivotal to achieving and maintaining low CA-BSI rates, training~     and retention of proper bundle compliance remains a challenge.~      The investigators prospectively compared this simulation-based program to a standard~     educational approach.~      The investigators hypothesized that implementation of bedside simulation-based training of~     CVL dressing changes by registered nurses would improve CVL maintenance bundle compliance.~   "
122768|NCT01960543|"~     Elderly patients with hip fracture are frail due to associated comorbidity. In these~     situations, regional anesthesia is recommended as it is associated to less postoperative~     cognitive dysfunction. However, hypotension during the process may impair ischemic~     cardiopathy and induce a cerebrovascular stroke. Selection of the right anesthetic agent and~     the administration of vasoactive drugs during the process can minimize these risks. Although~     bupivacaine and levobupivacaine share pharmacokinetic and pharmacodynamic properties, the~     studies show conflicting results. The aim of this study is to investigate if there are~     clinically relevant differences between these two drugs in terms of hemodynamic parameters~     during the surgical process with special focus on the effects on regional cerebral oximetry~     and cognitive status after surgery.~   "
122769|NCT01960530|"~     This study will investigate a new drug called Infacort®; a newly-developed immediate release~     formulation of a well-established drug called hydrocortisone. Hydrocortisone is used as a~     replacement treatment for people whose adrenal glands are not producing enough natural~     cortisol - a condition known as adrenal insufficiency. The study will assess how Infacort®~     acts once inside the body, by measuring cortisol and other hormone levels in the body,~     compared to already marketed hydrocortisone tablet and hydrocortisone intravenous (through~     the vein) injection.~      The population who are eligible to take part in the study are healthy male volunteers, aged~     between 18 and 60 years of age.~   "
122770|NCT01960517|"~     This is a single centre, non-randomised, baseline controlled, prospective pilot clinical~     trial to be undertaken at Rotherham General Hospital, Rotherham, UK.~      The study will examine the safety and performance of a new urinary catheter, the Alternative~     Catheter System (ACS) (Alternative Urological Catheter Systems Ltd (AUCS), Bristol, UK) which~     has been developed to reduce the morbidity of long-term catheterisation and the acknowledged~     deficiencies of the conventional Foley urinary catheter.~   "
122771|NCT01960504|"~     BIOSOLVE-II is a prospective, international, multicenter, First in Man study. The purpose of~     this study is to assess the safety and clinical performance of the drug eluting absorbable~     metal scaffold (DREAMS 2nd Generation).~   "
122772|NCT01960491|"~     The objective of this study is to evaluate the effectiveness and the safety of the~     intracardiac septal closure device (CBO), as well as the practicability of implantation of~     this device using the accessories (DS for CBO).~   "
122773|NCT01960478|"~     In the USA, every year 795,000 patients suffer a cerebral vascular accident (CVA), which~     represents a yearly cost of $73.7 billion. CVA is the third main cause of death and the main~     source of acquired handicap in adults, as a result it is now a key priority in public health~     and part of  The CVA National Action Plan 2013-2014.~      Copeptin is a polypeptide, by- product of Vasopressin metabolism. The increase of Copeptin~     plasma level, as for Vasopressin, is connected to hydric balance disorders found in~     cardio-vascular, renal and endocrine diseases. This link has already shown its interest in~     the early diagnosis of myocardial infarction and, in a more indirect way, CVA.~      Copeptin is associated with acute endogenous stress. It seems to have interesting potential~     in the diagnosis of CVA by its negative predictive value like D-dimeres in pulmonary~     embolism. Proadrenomedullin and Brain Natriuretic Peptide (BNP) are both associated with the~     prognosis of cardio-vascular diseases and could be interesting in evaluating CVA prognosis.~   "
122892|NCT01958918|"~     This is a 12-month, phase IV, randomized, open label, multicenter study to compare efficacy~     of 0.5 mg ranibizumab pro re nata treatment versus 2 mg aflibercept bimonthly intravitreal~     injections on central retinal thickness (CRT) stability as measured by mean CRT fluctuations~     between month 3 and month 6 of treatment by spectral domain optical coherence tomography~     (SD-OCT) and explore functional outcomes up to month 12 in patients with neovascular (wet)~     age-related macular degeneration (AMD). Approximately 500 patients will be randomized in~     Europe.~   "
122774|NCT01960465|"~     Obstructive sleep apnea (OSA) is a major public health problem in the U.S. and more than 35%~     of Veterans are at high risk for OSA. OSA is associated with progression of hypertension, an~     important health problem in Veterans. African Americans with OSA are at increased risk for~     poorly controlled hypertension and its health consequences. Implementing a care plan to~     increase the percentage of Veterans in whom blood pressure goals are achieved has been~     prioritized by Veterans Administration hospitals. Recent studies show that hypertension~     control can be improved with continuous positive airway pressure (CPAP) treatment of OSA. The~     aim of this proposal is to examine and compare the effects of CPAP treatment on 24-hour~     arterial blood pressure and central aortic blood pressure (measured non-invasively with a~     cuff on the upper arm) in African American and other Veterans.~   "
122775|NCT01960452|"~     Insomnia, defined as a subjective report of difficulty initiating sleep, maintaining sleep,~     and/or non-restorative sleep, leads to significant daytime dysfunction and increased health~     risks. A commonly held hypothesis is that insomnia is caused by a state of hyperarousal, but~     the neurobiological mechanisms of hyperarousal in insomnia are poorly understood, in part~     because of limitations in our ability to image the brain during normal human sleep with~     sufficient temporal resolution. Furthermore, the efficacy of insomnia treatment is judged by~     subjective report of the patient and demonstration of changes in sleep latency and/or sleep~     amount which are generally small in magnitude; there are currently no data to demonstrate~     that insomnia treatments correct any functional abnormalities in the sleep process that~     likely contribute to neurobehavioral abnormalities and health risks. The goals of the~     proposed study are to use high density EEG to define abnormalities in specific aspects of~     sleep in insomnia patients compared to healthy sleeping control subjects to define biomarkers~     that will both increase our understanding of the pathophysiology of insomnia as well as~     provide targets to assess treatments for insomnia.~   "
122776|NCT01960439|"~     The purpose of this study of this study is to assess the responsiveness and validity of CIMS~     (Central Image Management System)-based endoscopic evaluation of UC (Ulcerative Colitis)~     clinical disease activity by measuring:~      The responsiveness central reader endoscopic EIs [(Endoscopic Indices) (MMCS (Modified Mayo~     Clinic endoscopy Subscore), UCEIS (Ulcerative Colitis Endoscopic Index of Severity) MBS~     (Modified Baron Score)] to clinical change from baseline to week 6 in a prospective trial of~     a treatment of known efficacy in UC.~   "
122777|NCT01960426|"~     Utilization of health resources in a testing based strategy versus an empiric dose escalation~     strategy to manage Crohn's disease and Ulcerative Colitis in subjects with loss of response~     to infliximab or adalimumab.~   "
122778|NCT01960413|"~     In this feasibility trial, the investigators will compare participants treated with~     montelukast and hydroxyurea to those treated with placebo and hydroxyurea for a total of 8~     weeks.~   "
122779|NCT01960400|"~     The efficacy of the current standard non-pharmacological treatments for complex regional pain~     syndrome (CRPS), a painful syndrome mostly occurring after musculoskeletal trauma, is~     suboptimal. It thus appears essential to examine new non-pharmacological therapeutic imagery~     (GMI) - a non-pharmacological approach with the highest level of evidence (level II). As~     suggested by the most recent clinical guideline 2, a potential solution would be to add an~     electrotherapeutic procedure - transcranial direct current stimulation (tDCS) - that may~     prove effective in modulating cortical excitability and reducing the effect of cortical~     reorganization on pain. Given the positive results previously obtained in patients with~     neuropathic pain, it is hypothesized that tDCS will prove to be an innovative add-on~     treatment method for CRPS patients, and help reduce pain and disability.~   "
122780|NCT01960387|"~     The combination of clofarabine and cytarabine is an effective and reasonably well-tolerated~     treatment regimen in patients with either relapsed/refractory or newly diagnosed AML. For~     this prospective study, we propose the use of clofarabine and cytarabine for second course~     induction therapy for patients with persistent AML after treatment with an anthracycline and~     cytarabine.~   "
122781|NCT01960374|"~     The purpose of the study is to assess the safety, tolerability and PK of selumetinib~     (AZD6244; ARRY-142886) (Hyd-Sulfate) in healthy male Japanese and non-Japanese Asian~     volunteers following administration of a single dose. Standard safety assessments including~     ECGs, vital signs, blood/urine safety tests, PK samples and monitoring of adverse events and~     an optional exploratory pharmacogenetics will be performed.~   "
122782|NCT01960361|"~     The current prospective clinical study's aim is to determine ABT's ICE implant survival rate,~     crestal interproximal bone resorption during 24 months post implant insertion and to~     assimilate the drilling sequence during the clinical use of ICE implants.~   "
122783|NCT01960348|"~     The purpose of this study is to evaluate the safety and efficacy of patisiran (ALN-TTR02) in~     patients with transthyretin (TTR) mediated amyloidosis~   "
122784|NCT01960335|"~     Dietary manipulation is proving to be an effective lifestyle strategy to combat the obesity~     epidemic. Increased dietary protein is one effective strategy. For example, increased whey~     protein ingestion with and without exercise training is associated with enhanced weight loss,~     body composition and subjective hunger in overweight and obese individuals. Our findings~     suggest that the effects of whey protein ingestion occur independent of a calorie-restricted~     diet and to a greater extent in individuals following a combined exercise program of~     resistance exercise, sprint intervals, stretching/yoga/pilates, and aerobic exercise training~     compared to standard resistance training.~   "
122785|NCT01960322|"~     The specific aim is to pilot-test our developed intervention manual's ability to improve~     patients' adherence to medications and medical outcomes (rejection rate, liver enzyme levels)~     in participating centers.~   "
122786|NCT01960309|"~     This is a cross-sectional pilot study to assess coronary artery disease with minimal invasive~     techniques in patients with asymptomatic troponin elevation after noncardiac surgery. The~     primary objective is to quantify coronary artery disease, as determined by coronary CT and~     MR, as a cause of postoperative myocardial injury. The secondary objective is to correlate~     coronary calciumscore to postoperative levels of troponin.~   "
122893|NCT01958905|"~     The general objective of the study is to answer to the question: Is the current dose of AL~     less efficacious in the severely malnourished compared to the non-severely malnourished~     children, and is PK in cause? We aim to assess whether the current treatment dose is~     adequate for children with severe acute malnutrition, and we hope results will guide further~     recommendations for malaria treatment in this specific population.~   "
122789|NCT01960270|"~     Unilateral sacral neuromodulation (SNM) has emerged as a valuable treatment for patient with~     low urinary tract dysfunction when failure or bad tolerance to anticholinergic treatment for~     overactive bladder. However, in the medium or long term, some patients failed to benefit from~     unilateral stimulation (unilateral neuromodulation). A contralateral stimulation could be~     tested then implanted to restore the efficacy. An other option is to perform a bilateral~     stimulation of the sacral nerves that could lead to a summation effects better than~     unilateral stimulation. Therefore, if a unilateral sacral nerve stimulation fails, a~     contralateral or a bilateral test should be considered.~   "
122790|NCT01960257|"~     This study uses an ingestion sensor and a wearable sensor (worn as a patch on the skin),~     which are new Proteus Digital Health (PDH) technologies approved by the FDA, to collect~     information about patients taking their TB medications. The wearable sensor records~     information, which is uploaded wirelessly to a mobile device and then to a secure computer.~     Together the sensors and the mobile device transmitting the information to the study computer~     are called a digital health feedback system (DHFS), which gives healthcare providers~     information about when patients have taken their TB medications. The advantage of the DHFS is~     that patients can take their medication where and when it is convenient for them, and do not~     have to wait for a nurse to directly observe them taking their medication.~      The purpose of this study is to find out if using these new technologies works as well as the~     standard method of observing in person when patients take their TB medications. This study~     will also look at the costs of using a DHFS for TB medications, what patients and healthcare~     providers think about using it, and other factors that can determine when one approach works~     better than another.~      This study has two parts. For the first part of the study (Step I), patients will have an~     initial screening visit and then, in one two-week period, they will have 4 study visits at~     the UCSD AntiViral Research Center (AVRC) and routine visits from Public Health Services~     (PHS) workers. This part of the study is designed to confirm that the DHFS is working~     correctly and is accurately collecting information about each dose of medication that~     patients take, and to understand what patients and healthcare providers think about using the~     DHFS.~      If patients are eligible for the second part of the study (Step II) and want to continue,~     that will last another 8-14 weeks with an additional 4 study visits at the AVRC. In the~     second part of the study, patients will be randomized into one of the following two groups.~      Group 1: TB treatment is monitored by continued use of the DHFS~      Group 2: TB treatment is monitored by the standard methods used by PHS (DOT)~      The second part of the study is designed to compare these two methods of observing patients~     taking their TB medications, what the relative costs of these methods are , and the~     perception by patients and/or healthcare providers of the ease of use of the novel~     technology.~   "
122791|NCT01960244|"~     The CASCADE-FH Registry is a national, multi-center initiative that will track the therapy,~     clinical outcomes, and patient-reported outcomes over time. The registry represents a~     collaboration between The Familial Hypercholesterolemia Foundation, the Duke Clinical~     Research Institute, lipid specialists, cardiologists, primary care providers, quality~     improvement personnel, and patients, all aiming to increase FH awareness, promote optimal~     disease management, and improve FH outcomes.~   "
122792|NCT01960231|"~     Type 2 diabetes mellitus patients exhibit many glucose homeostasis abnormalities in different~     tissues and organs. Among the more important defects are disturbed hepatic glucose metabolism~     and defective pancreatic β-cell function. Hexokinase IV, commonly known as glucokinase, is~     the predominant hexokinase expressed in the liver, the pancreatic β-cells (where it functions~     as the glucose sensor for insulin secretion) and in glucose-sensory cells in the hypothalamus~     and gut.~      The glucokinase gene contains two distinct promoters. The downstream one is active only in~     hepatocytes and the upstream promoter is active only in extrahepatic glucose sensory-cells.~     Alternative promoters enable differential regulation of gene transcription in liver and~     extrahepatic sites. In pancreatic β-cells, glucokinase expression at the mRNA level is~     largely constitutive, whereas in the liver it undergoes large adaptive changes in response to~     nutritional states, enabling larger changes in glucokinase activity than would otherwise be~     possible by post-transcriptional regulation alone.~      Most of the MODY-2 patients were found to have glucokinase mutations located in areas that~     are common to the liver and pancreas. The diabetes in these patients is related both to~     defect in insulin secretion and abnormal hepatic glucose metabolism. Point mutation in the~     pancreatic specific promoter was recently described as a cause for impaired fasting glucose~     [Diabetes 58:1929-1935, 2009]. The investigator have recently identified a MODY-2 family with~     a genetic defect that is located in the pancreatic promoter, sparing the liver promoter. This~     family demonstrates that abnormal insulin secretion alone (perhaps together with other~     extrahepatic glucose sensors) is enough to cause diabetes.~      In this study, the investigators would like to use an oral glucose tolerance test (OGTT) and~     continuous glucose monitoring (CGM) technique in order to elucidate the relative roll of the~     hepatic glucokinase in normal glucose homeostasis. This issue is complicated by the fact that~     in addition to glucokinase, hexokinase isoenzymes I, II and III are also expressed at very~     low levels in hepatocytes. They are an important back-up mechanism when glucokinase activity~     is compromised, as in liver cirrhosis or murine models with liver-specific glucokinase~     knock-down. However, impaired hepatic glycogen synthesis was demonstrated in MODY-2 subjects~     (JCI 1996:98:1755). By comparing members of the investigators MODY-2 family with members of~     other MODY-2 families and normal controls the investigators hope to shade some light on this~     question.~   "
122793|NCT01960218|"~     To determine whether, and if so, which gas exchange parameters measured on the Shape-HF~     Cardiopulmonary Exercise Testing System predict 30 and 180 day re-hospitalization in subjects~     discharged from hospitalization for an episode of acute decompensated heart failure.~   "
122794|NCT01960205|"~     The purpose of the study is to examine the effect of Saxagliptin in the newly diagnosed~     people with pre-diabetes and obesity besides lifestyle intervention ,there to evaluate DPP 4~     inhibitors of reversing pre-diabetes curative effect to normal blood sugar, and observe its~     influences on the targets of obesity related metabolic abnormalities, to explore new ways for~     intervention on populations with pre-diabetes and obesity .~   "
122795|NCT01960192|"~     The purpose of this study is to evaluate the efficacy and safety of FVD regiment~     (fotemustine, teniposide and dexamethasone ) for patients with primary CNS lymphoma.~   "
122796|NCT01960179|"~     Primary Objective:~      To assess the overall safety of lixisenatide once daily treatment in monotherapy over 24 and~     52 weeks in patients with type 2 diabetes in Japan~      Secondary Objective:~      To assess the effects of lixisenatide once daily treatment in monotherapy over 24 and 52~     weeks on:~        -  HbA1c (Glycated hemoglobin A1c) reduction;~        -  Fasting plasma glucose;~        -  Body weight.~   "
122797|NCT01960166|"~     The investigators proposed study will investigate the efficacy of tablet computer distraction~     as an analgesic for the pain associated with various painful procedures in the emergency~     department. Since prior studies have shown that distraction by a parent or nurse can be an~     effective analgesic, there is reason to believe that tablet computer distraction will~     similarly reduce pain. Participants in the control group will receive a cartoon on the TV~     monitor in the patient room, while participants in the study group will receive a more~     immersive distraction of playing a game or watching a cartoon (for children too young to play~     a game) on a tablet computer. Data from this study will help inform best practices for~     administering painful procedures in a way that minimizes pain.~   "
122798|NCT01960153|"~     PITCH-ER is an ancillary study of PITCH-HF (NCT01910389). The goal of the PITCH-ER ancillary~     study is to evaluate the rate of decline in renal function and frequency of development of~     acute kidney injury (AKI) in patients enrolled in PITCH-HF (who have heart failure and~     pulmonary hypertension) treated with chronic tadalafil treatment compared to placebo.~   "
122799|NCT01960140|"~     The purposes of this study are to determine the effects of baricitinib on the time it takes~     to remove simvastatin from the body and to look at how well-tolerated and safe baricitinib is~     when given alone and in combination with simvastatin. Side effects will be documented. The~     study will last approximately 7 days from the first dose to the end of the study (not~     including screening or follow-up).~   "
122800|NCT01960127|"~     Cirrhosis is associated with a reduction in muscle mass and exercise capacity. This has an~     impact on morbidity and mortality. Regular aerobic exercise training is a proven effective~     therapy to improve exercise capacity in healthy and clinical populations. The effect of this~     training has not yet been evaluated in the decompensated cirrhosis patient population. The~     safety of this intervention also requires further study. Using a randomized controlled~     design, the investigators aim to determine the safety and efficacy of eight weeks of aerobic~     exercise training on aerobic capacity, functional performance, and muscle mass in~     decompensated cirrhosis patients.~   "
122801|NCT01960114|"~     The purpose of the study is to evaluate the efficacy and safety of acetaminophen ER 1500 mg~     (two 750 mg tablets) over 10 to 12 hours in the dental pain model following third molar~     extraction(s) and to evaluate the pharmacokinetics of acetaminophen ER 1500 mg (two 750 mg~     tablets) in a sub-group of subjects.~   "
122802|NCT01960101|"~     Dry mouth is in most cases due to iatrogenic causes, particularly drugs. The existing~     products such as saliva substitutes are often disappointing (bad taste, poor efficiency).~      Our hypothesis has considered the empirical observations made by some patients with~     xerostomia who consumed milk products to relieve the dry mouth syndrome from which they~     suffered. With this clinical observation, a closer collaboration has been undertaken with~     research laboratories specialising in food and especially milk. Through its composition, the~     dairy product in itself provides relief for the patient, due both to its physical and~     biochemical properties, which could explain these observed improvements, and elements related~     to the phenomena of consumption of food as an alternative to medication. In the latter,~     hedonism takes on a role which has not been previously assessed. Initial work undertaken with~     the department of applied research at the National Dairy Industry School (ENIL) led to the~     prototyping of a new natural milk, which is the subject of this application for development,~     to qualify and adapt a product with a health benefit in patients suffering from xerostomia.~      To further develop this project we will initiate a sequential clinical trial by groups of~     five ambulatory patients with xerostomia (patients taking antidepressants followed in~     psychiatry appointments). The clinical tests will be organised by the CIC with the~     psychiatric wards of the University Hospital of Besançon. Each group of 5 patients will test~     a similar product for 14 days. The information collected after a series of tests with a group~     of patients will be translated by changing the ENIL specifications to produce a new~     mini-series of products. This repetition will be carried out up to 3 times if necessary to~     help achieve a satisfactory product in terms of taste, texture and lubrication properties,~     which will then be tested in a randomized controlled cross-over study of the efficiency and~     acceptability of the new LactoXeros product versus a reference product (Aequasyal ®,~     Oxidized Glycerol Triester) on a group of 32 patients at the University hospital of Dijon.~      A natural way to combat xerostomia at the interface of patient diet, such as we propose,~     could help improve quality of life for patients, minimize harmful effects (infection, decay)~     and promote adherence of patients to treatments which are responsible for xerostomia.~   "
122803|NCT01960088|"~     The study aims to expand the evidence supporting pharmacy provision of adolescent vaccines,~     including human papillomavirus (HPV) vaccine. In the first part of the study, we will~     characterize parents' attitudes and support for pharmacy provision of adolescent vaccines in~     a national survey. In the second part of the study, we will provide HPV vaccines and other~     vaccines (Tdap, meningococcal, varicella, influenza) to 200 adolescents in a local community~     pharmacy in Chapel Hill, North Carolina. This portion of the study will identify the systems~     and workflow needed to provide vaccines effectively and safely, characterize parents' and~     their adolescents' attitudes toward receiving vaccine services in a pharmacy, and~     characterize pharmacists' attitudes toward providing adolescent vaccine services in a~     pharmacy.~   "
122804|NCT01960075|"~     The primary objective is to determine the most effective and/or the least effective treatment~     of benzodiazepine-refractory status epilepticus (SE) among patients older than 2 years. There~     are three active treatment arms being compared: fosphenytoin (FOS),levetiracetam (LEV), and~     valproic acid (VPA).~      The second objective is comparison of three drugs with respect to secondary outcomes.~      The final objective is to ensure that the trial is informative for treatment of established~     SE in children by describing the effectiveness, safety, and rate of adverse reactions of~     these drugs in children.~   "
122805|NCT01960062|"~     Between October 1 and November 30, 2011, participants will be enrolled in this study~     comparing the use of MyLink web-based care with usual CPS care. Patients age 18- 74 with~     HbA1c ≥ 9% in the last 12 months will be identified. It is expected that approximately 32~     people (16 per group) will participate in the study. Once eligible patients are found, they~     will be randomly assigned (like the flip of a coin) to usual care with the CPS or usual care~     with the CPS plus web-based care using the MyLink software. Participants using the software~     will agree to upload their glucometer measurements using the software every 2- 4 weeks.~     Following the receipt of the glucometer data, either electronically from intervention group~     participants or verbally from the control group participants, medications/ doses will be~     adjusted by the pharmacist as needed to achieve HbA1c goals. Participants in both groups will~     receive a follow-up HbA1c 2-4 months after enrollment to see if there were any significant~     changes in HbA1c between groups.~   "
122806|NCT01960049|"~     Abdominal wall incisions used for liver surgeries are associated with significant~     postoperative pain and disability. Epidural analgesia is often contraindicated in these~     patients due to common bleeding problems. Furthermore, drugs such as acetaminophen and~     opioids are often inadequate and can lead to detrimental side-effects. Abdominal wall (AW)~     catheters can be placed during surgical closure along the incision line and can be used to~     administer local anesthetics for postoperative pain. The study is a multi-centre,~     double-blind, randomized controlled trial involving 120 patients undergoing elective liver~     surgery. Patients will be randomly assigned to AW catheter group treated with drug or control~     treated with saline. Treatment group will receive AW catheters with ropivacaine plus standard~     patient controlled analgesia (PCA). Control group will obtain AW with normal saline and no~     local anesthetics and PCA. Patients are followed for 6 months post-operatively for pain~     scores, side-effects, chronic pain and complications.~   "
122818|NCT01959893|"~     Fibromyalgia Syndrome (FMS) is a highly prevalent condition, often affecting individuals at~     the prime of life, causing severe reduction of quality of life and productivity, as well as~     social isolation, anxiety and depression.~      FMS is a condition characterized by chronic widespread pain, considered to be a manifestation~     of central nervous system sensitization, leading to increased processing and transmission of~     pain. At the same time however, it has become gradually more evident, that FMS is not merely~     a pain syndrome. Those patients who suffer from the full-blown clinical syndrome of FMS~     inevitably describe many additional symptoms beside pain. While some of these symptoms, such~     as heightened sensitivity to external stimulations (e.g. noise and light), can easily be~     understood as representing aspects of the basic underlying propensity towards central~     sensitization, other symptoms are not so easily explained in this context.~   "
122807|NCT01960036|"~     The long-term objective of this study is to improve women's substance use disorder (SUD)~     treatment. The immediate project goal is to test the efficacy of an innovative mind-body~     intervention, Mindful Awareness in Body-Oriented Therapy (MABT) to reduce substance use~     relapse among women in SUD treatment.~      A novel mind-body approach, MABT combines a hands-on (manual) approach with mind-body~     psycho-education approaches of interoceptive training and mindfulness to develop~     somatically-based self-care skills and to facilitate emotion regulation. A three-group,~     randomized clinical trial using repeated measures, this project will enroll and randomize 225~     women to one of three groups, MABT + Treatment-as-usual (TAU) (n=75), TAU only (n=75), and~     Women's Health Education (WHE) + TAU (to control for time and attention) (n=75). Study~     conditions will be compared at baseline, post-intervention, and at 6 and 12 month follow-up.~      The primary aim is to test the hypothesis that MABT will result in reduced substance use and~     related health outcomes compared to TAU and to WHE+ TAU at 12 month follow-up. The second aim~     is to examine hypothesized underlying mechanisms of MABT. Female outpatients in two diverse~     community treatment facilities, serving racially diverse patients, will be recruited for~     study participation. This study builds on promising preliminary evidence of MABT feasibility~     and acceptability in substance use disorder treatment for women, and addresses the need for~     more clinical research aimed at improving SUD treatment outcomes for women.~   "
122808|NCT01960023|"~     The FC-7 study is designed as an open label, single arm, Phase I/II dose-escalation study~     evaluating the combination of neratinib and cetuximab in patients with metastatic colorectal~     cancer primary tumor that is quadruple wild-type  (wild-type KRAS, NRAS, BRAF, PIK3CA). The~     primary aim in the Phase I portion of this study is to determine the safety and tolerability~     of the two-drug combination. The primary aim of the Phase II part is to determine the overall~     objective response rate (complete and partial responses) by Response Evaluation Criteria in~     Solid Tumors (RECIST 1.1).~      Patients will receive concurrent therapy with cetuximab (400 mg/m2 IV loading dose followed~     by 250 mg/m2 IV weekly), and neratinib.~   "
122809|NCT01960010|"~     The purpose of this study is to assess the safety and efficacy of MIM-D3 Ophthalmic Solution~     compared with Placebo Ophthalmic Solution in treating the signs and symptoms of dry eye.~   "
122810|NCT01959997|"~     The objective of this study is to compare the elimination of atrial fibrillation in patients~     with recurrent atrial fibrillation despite prior pulmonary vein isolation (PVI) when~     undergoing repeat PVI (control) vs repeat PVI plus renal denervation.~   "
122811|NCT01959984|"~     The object of this study is to compare 100g Standard Noodles  with traditional~     carbohydrates including 75g glucose solution in 300ml water and 100g steamed bread in the~     diagnosis of diabetes mellitus.~      In this study, we will compare the different effects of 100g Standard Noodles Tolerance~     Testand 75g Oral Glucose Tolerance Teston plasma glucose, insulin, c- peptide level and~     the relevant hormones level including glucagon-like peptide-1( GLP-1) and glucagon. Besides,~     in part of the subjects, the difference between 100g Steamed Bread Tolerance Test, 100g~     Standard Noodles Tolerance Test and 75g Oral Glucose Tolerance Test will be further~     evaluated.~   "
122812|NCT01959971|"~     Primary Objective:~      To assess the effects of subcutaneous (SC) doses of alirocumab on the elimination (measured~     by Fractional Clearance Rate (FCR)) of apolipoprotein B (apoB) in low density lipoprotein~     (LDL) in adults with mildly elevated LDL-cholesterol (LDL-C).~      Secondary Objectives:~      To assess the effects of SC doses of alirocumab on:~        -  Various parameters of the metabolism and turnover in plasma of different lipoproteins~        -  Plasma lipids concentration: total cholesterol, high density lipoprotein cholesterol~          (HDL-C), triglycerides, low density lipoprotein cholesterol (LDL-C), apoB,~          lipoprotein(a) (Lp(a))~        -  Lipoprotein particle size profile~        -  PCSK9 (free and total) concentrations in serum To assess safety and tolerability of~          alirocumab. To assess emergence of anti-alirocumab antibodies. To document serum~          alirocumab concentrations.~   "
122813|NCT01959958|"~     Pediatric patients with sickle cell disease are at greater risk for exhibiting nocturnal~     enuresis (bedwetting) compared to the general population. This increased risk has been~     attributed to a decreased ability to concentrate urine caused by sickling-induced~     nephropathy. The sociodemographic, psychosocial, and medical factors associated with~     nocturnal enuresis are not well defined. In addition, the impact of these behaviors on~     emotional and behavioral functioning, along with health-related quality of life are not~     clear. Despite the availability of evidence-based interventions for nocturnal enuresis, very~     few families with a child with sickle cell disease have utilized these methods. The reasons~     for this underutilization of interventions are not clear.~   "
122814|NCT01959945|"~     Flublok was studied previously in children 6 -59 months of age and demonstrated less than~     satisfactory immunogenicity results, especially in the 6-36 month age group. Thus, the~     initial introduction of Flublok Quadrivalent Formulation (RIV4) into the pediatric population~     will evaluate immunogenicity and safety older children and adolescents, aged 6-17. This~     clinical trial is designed to demonstrate safety and non-inferior immunogenicity of Flublok-Q~     in pediatric subjects 6-17 years of age as compared to IIV4. Positive results in this study~     may support further studies in younger children.~   "
122815|NCT01959932|"~     The overall goal of the study is to evaluate if the ad libitum use of the Tobacco Heating~     System 2.2 (THS 2.2) for 5 days by adult healthy smokers results in a reduction in the levels~     of biomarkers of exposure (BoExp) for selected harmful and potentially harmful constituents~     (HPHCs) compared to smoking conventional cigarettes (CC) and smoking abstinence (SA).~   "
122816|NCT01959919|"~     This study aims to investigate prospectively throughout a period of 3- 6 months and not to~     exceed 12 months (according to local therapeutic plans) patients experiences of treatment~     with Factor VIII in the new device named FuseNGO, a new delivery system for Factor VIII~     compared to their previous delivery system.~   "
122817|NCT01959906|"~     A suspicious circumferential resection margin (CRM), defined as tumor cells within 1 mm of~     the CRM, is still controversial. The aim of this study was to compare the clinical~     significance of a suspicious CRM to histologically positive (R1) and negative margin (R0)~     resections in patients with pT3 esophageal and GE-Junction tumors.~   "
122894|NCT01958892|"~     The purpose of the study is to assess whether transurethral enucleation of prostate gives~     better or equivalent outcomes compared to the gold standard of transurethral resection of the~     prostate~   "
122824|NCT01959815|"~     Patients with scleroderma can develop heart failure due to high blood pressure in the lungs~     (a condition called pulmonary arterial hypertension). It is important to find pulmonary~     arterial hypertension early, so that it can be treated before heart failure develops.~     However, the tests that we now use to find the earliest form of this disease in scleroderma~     patients are not good enough. This study will examine whether tests performed during exercise~     can improve our ability to find early pulmonary arterial hypertension. The study will also~     try to identify genes that are responsible for the development of pulmonary arterial~     hypertension.~   "
122825|NCT01959802|"~     Evaluation of recovery in foveal cone outer segment tips line defect and visual acuity after~     surgery for macular pseudohole~   "
122826|NCT01959789|"~     The calcium containing 35% hydrogen peroxide gel employed in this study can be re-applied 2~     days after the first bleaching session without increasing the bleaching-induced tooth~     sensitivity~   "
122827|NCT01959776|"~     Evaluation of asymmetry in recovery of cone outer segment tips and foveal displacement after~     macular hole surgery~   "
122828|NCT01959763|"~     This intervention aims to reduce obesity by using new type of nutritional and lifestyle~     therapy and in parallel, tailored persuasive information and communications technology~     (ICT)-technology based application. The study hypothesis is that obesity cannot be reduced~     just by distributing nutritional information. Instead, by influencing also the eating~     behavior, permanent lifestyle changes can be achieved. The effect of the therapy along the~     time-line, the health information literacy of the study persons and the changes in it will be~     studied at different phases of the intervention. The research will be carried out in three~     groups of different nutritional therapies with a parallel ICT-intervention group for each.~   "
122829|NCT01959750|"~     ICU caregivers face up to a demanding job with a high level of technical skills, a stressful~     environment, and a heavy work load. They run a high risk of developing burnout that can~     impact on their welfare, performance, and patient care. Burnout favours absenteeism and staff~     quitting their jobs, whereas the shortage of ICU caregivers already started. No randomised~     controlled intervention aimed at reducing such distresses had been run until now.~      This study allowed finding a new method of psychological support applicable in the special~     environment of ICU. Our findings suggest that psychologists specifically assigned to treat~     ICU caregivers might be beneficial on their burnout.~   "
122830|NCT01959737|"~     The first hours after birth are a sensitive period for promotion of optimal~     mother-child-interaction and secure attachment. Maternal sensitivity and responsivness are~     high in the first hours after birth due to high oxytocin levels. Developing optimal~     mother-child-interaction is more difficult for preterm mothers because mother and child are~     separated after birth and the preterm infant is not able to show strong signs to promote~     maternal sensitivity. We hypothesize that promoting skin-to-skin contact of VLBW infants and~     their mothers for 60 minutes within the first hours after birth improves~     mother-child-interaction at 5 to 6 months corrected age. We also hypothesize that reactivity~     of HPA axis and molecular patterns of stress signaling pathways differ in preterm infant with~     or without SSC after birth.~   "
122831|NCT01959724|"~     Evaluation of clinical characteristics and surgical outcome for macular detachment associated~     with peripapillary intrachoroidal cavitation with or without pathologic myopia.~   "
122832|NCT01959711|"~     Laparoscopic adrenalectomy has become the gold standard operation for non-malignant adrenal~     tumors replacing open adrenalectomy. The most popular lateral transperitoneal laparoscopic~     adrenalectomy (LTLA) approach has been recently challenged by an increasing popularity of the~     posterior retroperitoneoscopic adrenalectomy (PRA) approach which is believed by many~     surgeons as an easy to learn, reproducible and beneficial for patients. However, this belief~     is not evidence-based, so far. The aim of this study is to clarify if PRA is superior to the~     LTLA as minimally invasive approach to small and benign adrenal tumors.~   "
122833|NCT01959698|"~     This phase I/II trial studies the side effects and best dose of carfilzomib when given~     together with rituximab, ifosfamide, carboplatin, and etoposide and to see how well it works~     in treating patients with stage I-IV diffuse large B-cell lymphoma that has returned~     (relapsed) or that has not responded to treatment (refractory). Carfilzomib may stop the~     growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal~     antibodies, such as rituximab, may block cancer growth in different ways by targeting certain~     cells. Drugs used in chemotherapy, such as ifosfamide, carboplatin, and etoposide, also work~     in different ways to stop the growth of cancer cells, either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading. Giving carfilzomib with~     rituximab, ifosfamide, carboplatin, and etoposide may be a better treatment for diffuse large~     B-cell lymphoma.~   "
122834|NCT01959685|"~     To determine the tolerability and pharmacokinetics (PK) of a single dose of Androxal in~     healthy adult male subjects as the dose to be investigated in a thorough QT~     interval/corrected QT interval (QT/QTc) study.~   "
122835|NCT01959672|"~     This phase II trial studies how well combination chemotherapy with or without oregovomab~     followed by stereotactic body radiation therapy (SBRT) and nelfinavir mesylate works in~     treating patients with pancreatic cancer that has spread to nearby organs or tissues. Drugs~     used in chemotherapy, such as gemcitabine hydrochloride, leucovorin calcium, and~     fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the~     cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal~     antibodies, such as oregovomab, can block tumor growth in different ways by targeting certain~     cells. Stereotactic body radiation therapy is a specialized radiation therapy that sends~     x-rays directly to the tumor using smaller doses over several days and may cause less damage~     to normal tissue. Drugs, such as nelfinavir mesylate, may make tumor cells more sensitive to~     radiation therapy. Giving combination chemotherapy with or without oregovomab followed by~     SBRT and nelfinavir mesylate may kill more tumor cells.~   "
122836|NCT01959659|"~     This non-interventional, cross-sectional survey and retrospective review will evaluate the~     medical resource utilization and burden of illness in patients who have persistent symptoms~     of schizophrenia despite receiving adequately dosed antipsychotic treatment and who have not~     had an acute exacerbation in the 3 months prior to enrolment. Medical records will be~     reviewed for a minimum of 3 months and up to 12 months prior to screening. Data collection at~     a single visit will include rating scales and questionnaires that reflect the clinical status~     and the quality of life of the patients and the economic impact of schizophrenia.~   "
122837|NCT01959646|"~     This is a nutritional intervention study using healthy overweight/obese humans to investigate~     if a supplement made from aged garlic extract has an impact on immunity. Following a baseline~     blood draw, participants will consume the capsules (garlic or placebo) for 42 days, at which~     time a second blood draw will occur. Tests for immune function and inflammation will be~     performed on both the baseline and 42 day samples. The investigators anticipate that the~     immune functions and biomarkers that are inflammatory in an overweight/obese population will~     be returning to normal after 42 days of consumption of this supplement. The investigators~     predict that AGE supplementation will benefit immunity and improve function while reducing~     inflammation in a stressed population (inflamed obese).~   "
122838|NCT01959633|"~     The hypothesis of this study is to evaluate the safety and the efficacy of~     Vemurafenib/PEG-interferon combination and the IFNAR1 upregulation lead by this treatment.~   "
122839|NCT01959620|"~     The overall aim of this study is to determine the optimal dose, 3-session exposure~     intervention versus 1-session exposure intervention compared to no treatment, for the~     delivery of exposure therapy in the immediate aftermath of trauma for preventing the~     development of posttraumatic stress disorder.~   "
122840|NCT01959607|"~     The overall goal of the study is to evaluate the pharmacokinetic (PK) profile (rate and the~     amount of nicotine absorbed) following a single use of the THS 2.2, a candidate Modified Risk~     Tobacco Product, compared to the PK profiles from a single use of a cigarette (CC) and from a~     single use of nicotine gum in a Japanese population.~   "
122841|NCT01959594|"~     This study is designed to evaluate the safety and plasma concentrations of PF-06412562 in~     healthy volunteers following three times daily oral dosing of PF-06412562 for 14 days~   "
122842|NCT01959581|"~     The purpose of this study is to assess: 1) how infants move their bodies to explore, play,~     and solve problems, 2) if this is different in a high-risk group of infants, and 3) if these~     abilities can be advanced in a high-risk group through the use of a movement assisting~     device.~   "
122843|NCT01959568|"~     Purpose: to assess the efficacy and safety of double tamponade versus silicone oil tamponade.~      Design: parallel-group study with balanced [1:1] stratified block randomization. Eligible~     participants are all adults aged 18 or over with first diagnosed rhegmatogenous total retinal~     detachment with retinal breaks located both in upper and lower retina. Also investigators~     include those patients with total retinal detachment with proliferative vitreoretinopathy~     (PVR) in which it is impossible to remove epiretinal membranes completely during the surgery~     (with arbitrary retinal breaks localization). Exclusion criteria are severe concomitant eye~     pathologies (glaucoma, diabetic retinopathy, macular hole, traumas etc) and eye length more~     than 27mm.~      Patients are randomized in two groups (test group and control group).~      In the test group patients undergo subtotal vitrectomy, epiretinal membrane removal,~     perfluorodecalin (PFD) tamponade, retinal photocoagulation. After that the surgeon replaces ½~     of PFD volume by conventional SO (with density less than one of water). The result is~     vitreous cavity (VC) filled in a half with PFD and in another half - with SO. In the control~     group patients undergo subtotal vitrectomy, epiretinal membrane removal, PFD tamponade,~     retinal photocoagulation and PFD-SO exchange, so the result is VC filled with conventional~     or heavy SO, depending on predominant retinal breaks location. 30 days after the surgery in~     both groups tamponing agents are removed from VC and VC is filled with sulfur hexafluoride~     gas (SF6) which dissolves during 1 month. Follow-up is at least 12 months.~      Along with standard examinations, after SF6 gas dissolution investigators perform spectral~     optical coherence tomography (OCT) and microperimetry. With OCT investigators measure~     thickness of retinal inner and outer nuclear layers. With microperimetry investigators~     determine light sensitivity in 12° and 4° zones from the fixation point.~      Outcome measures: reattachment rate, best corrected visual acuity (BCVA), intraocular~     pressure (IOP), thicknesses of inner and outer nuclear layers according to the OCT, light~     sensitivity according to microperimetry, the rate of cataract formation in phakic eyes and~     the rate of tamponing agents emulsification.~      For final analysis each group will include 145 participants.~      OCT, microperimetry data and visual acuity will be compared between the groups using~     Student's t-test; proportions will be compared using exact Fisher's test.~   "
122844|NCT01959555|"~     This study is conducted in Europe. The aim of the study is to update the knowledge about the~     prevalence and severity of congenital haemophilia (A and B) in Spain.~   "
122845|NCT01959542|"~     In this research study, the investigators are trying to determine if there are measurable~     changes in prostate MRI that will help predict those who will or will not respond to Androgen~     Deprivation Therapy (ADT) and External Beam Radiation Therapy (EBRT) The first baseline~     prostate MRI prior to the start of treatment is standard of care. The participant's ADT/EBRT~     treatment is also standard of care, as advised by their doctor. It is the 3 follow up~     prostate MRIs during ADT/EBRT treatment, and 4 follow up serum PSA levels that are part of~     this research study.~   "
122846|NCT01959529|"~     This trial is conducted globally. The aim of this trial is to compare cardiovascular safety~     of insulin degludec versus insulin glargine in subjects with type 2 diabetes at high risk of~     cardiovascular events.~   "
122847|NCT01959516|"~     This study purpose is to further study the profiles of glycopyrronium (NVA237) and tiotropium~     during the first hours after dosing and their impact on pulmonary function, COPD symptoms and~     ability to perform daily activities by the patient.~   "
122848|NCT01959503|"~     This study is being conducted to evaluate the safety and effectiveness of the Progel Vascular~     Sealant for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically~     sealing areas of leakage.~   "
122849|NCT01959490|"~     This phase II trial studies how well trastuzumab and pertuzumab or bevacizumab with~     combination chemotherapy works in treating patients with stage II-III breast cancer.~     Monoclonal antibodies, such as trastuzumab, pertuzumab, and bevacizumab, can block tumor~     growth in different ways. Some block the ability of tumors to grow and spread. Others find~     tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in~     chemotherapy, such as docetaxel, carboplatin, doxorubicin hydrochloride, cyclophosphamide,~     and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. Giving trastuzumab and pertuzumab or a~     commercially marketed formulation of bevacizumab without modification with combination~     chemotherapy may kill more tumor cells.~   "
122850|NCT01959477|"~     This clinical trial studies personalized dose monitoring of busulfan and combination~     chemotherapy in treating patients with Hodgkin or non-Hodgkin lymphoma undergoing stem cell~     transplant. Giving chemotherapy before a stem cell transplant stops the growth of cancer~     cells by stopping them from dividing or killing them. After treatment, stem cells are~     collected from the patient's peripheral blood or bone marrow and stored. The stem cells are~     then returned to the patient to replace the blood-forming cells that were destroyed by the~     chemotherapy. Monitoring the dose of busulfan may help doctors deliver the most accurate dose~     and reduce toxicity in patients undergoing stem cell transplant.~   "
125732|NCT01921738|"~     The aim of this study is to investigate the effects of Azithromycin (systemic and locally) on~     the clinical and microbiological parameters of periodontal in patients with chronic~     periodontitis.~   "
122853|NCT01959438|"~     In vitro studies have demonstrated that sodium selenite in sufficient concentration and~     during sufficient time have a high tumoricidal capacity. This is found in many human cell~     types as leukemia cells, mesothelioma and non-small cell lung cancer cells. A minority of~     cell lines seem to be resistant. The question from a clinical point of view is: Is it~     possible with respect to toxicity to administer sodium selenite to patients in sufficient~     dose and during sufficient time to get responses in patients with cancer? We have performed~     first part of phase-1 study and found MTD of 10.2 mg/m2 if given as 10 daily infusions during~     12 days. We have recorded limited anti-tumor effect in this treatment regimen. However, in~     vitro data suggest that low concentration of continuous exposure for 51 h is much more~     effective. Now we are planning to continue the phase-I trial with modified protocol.~      More specific:~        1. Phase I: Find maximal tolerable dose with continuous infusion~        2. Phase II: Use MTD and study responses, if any~   "
122854|NCT01959425|"~     The objective of this study is to determine the safety of discontinuing oral anticoagulation~     therapy in high risk patients who have had a successful cardiac ablation and remain AF~     recurrence free for 3 months post ablation.~   "
122855|NCT01959412|"~     The purpose of this study is to determine the efficacy of indacaterol 55µg once daily (and~     27.5 µg twice) in QVA149 compared to 75 µg indacaterol monotherapy.~   "
122856|NCT01959399|"~     The purpose of this study will be to assess the effect of multiple-doses of ASP015K on the~     pharmacokinetics of rosuvastatin in healthy adult male and female subjects.~   "
122857|NCT01959386|"~     This observational study will evaluate the efficacy, safety, tolerability and participant~     reported quality of life of trastuzumab (Herceptin) subcutaneous (SC) therapy in participants~     with HER2-positive early breast cancer in routine clinical practice. Data from eligible~     participants will be collected for the duration of their treatment (approximately 1 year) and~     for 1-2 years of follow-up.~   "
122858|NCT01959373|"~     Amyotrophic lateral sclerosis (ALS) is characterized clinically by abnormalities of both~     upper motor neurons (UMN) and lower motor neurons (LMN). The presence of UMN signs is not~     always easy to establish. The only technique used in routine to assess the corticospinal~     dysfunctions is based on transcranial magnetic stimulation (TMS). However, this technique is~     largely dependent on LMN state and is based on artificial motor cortex activation.~      The main objective of our study project is to evaluate a new method assessing functional~     changes in motor system in ALS patients. By using cortico-muscular and cortico-cortical~     coherences, it could be possible to show modifications in both cortico-muscular relationship~     and in cortical activity coordination which could be related to clinical state in ALS~     patients. We notably expect a decrease in cortico-muscular coherence in ALS patients.~     Furthermore, these analyses could provide new insights in motor system plasticity phenomena.~     We expect a partial covering of voluntary motor command by cortical areas adjacent to primary~     motor cortex. Lastly, the hypothesis that an increased proportion of voluntary motor control~     may be assumed by ipsilateral corticospinal tract could be tested by coherence analyses.~      Coherence analysis might be a useful method to detect corticospinal tract dysfunctions. This~     method has the advantage to be painless and not to use artificial stimulations as it is used~     in TMS.~   "
122859|NCT01959360|"~     The aim of the present study is to explore the most efficient surgical approach in total hip~     replacement in short and long term when concerning strength, functionality and postoperative~     complications.~      The objective is to register muscular strength, hip joint functionality/mobilisation and~     complications after total hip arthroplasty (THA) performed by two minimal invasive/incision~     surgeries (MIS) versus the traditionally lateral approach.~      The primary working hypothesis is that due to a minimal dissection and reduced trauma in the~     muscles, patients will tolerate early hospital discharge better after MIS than after~     traditional lateral surgery. Patients in the MIS group will also be more active and maintain~     muscular strength and hip joint functionality/mobilisation better than patients in the~     lateral group.~   "
122860|NCT01959347|"~     The overarching goal of this randomized trial is to estimate the effect of combined~     midurethral sling (MUS) and peri-operative behavioral/pelvic floor therapy (BPTx) compared to~     MUS alone on successful treatment of MUI symptoms in 472 women. Secondary objectives include~     estimating the effect of combined treatment compared to MUS on improving overactive bladder~     (OAB) and stress urinary incontinence (SUI) outcomes separately, need for additional~     treatment, time to failure and identifying predictors of poor outcomes in this MUI~     population.~      A supplemental study, The Human Microbiome Study of ESTEEM, will evaluate the urinary and~     vaginal microbiome as it relates to women with MUI, their treatment and unaffected controls.~   "
122861|NCT01959334|"~     In recent past years, regulatory agencies such as FDA and EMA have outlined and recommended~     adoption of a risk-based approach to evaluating and mitigating immune responses to~     therapeutic proteins that may adversely affect their safety and efficacy. In their~     recommendations, both transient and persistent antibody responses should be combined to~     determine the overall immunogenicity of a product in a given condition. In particular,~     persistent antibodies are of high importance, since patients with persistent antibodies are~     more likely to experience clinical sequelae in terms of safety and efficacy, while a~     transient antibody response can resolve without further consequence.~      The present study will provide information on immunogenicity of AMG504-1 with regards to the~     potential development of high antibody titers or neutralizing antibody activity which may~     lead to loss of efficacy or an increased risk of an adverse reaction.~   "
122862|NCT01959321|"~     This multi-center observational study examines risk factors for HCV transmission from mother~     to baby.~   "
122863|NCT01959308|"~     Immunosuppressive therapy is fundamental in post-liver transplant patients to prevent and~     reduce the incidence of acute cellular rejection. Non-compliance to treatment leading to~     graft rejection is a well-recognized event. This study aims to study the differences in~     patient compliance to immunosuppressive treatments and patient preference.~   "
122864|NCT01959295|"~     To evaluate the efficacy and safety of ASP2151 in patients with herpes simplex.~   "
122865|NCT01959282|"~     The purpose of the study is to evaluate dose response of JNJ-54781532 in participants with~     moderately to severely active ulcerative colitis (UC).~   "
122895|NCT01958879|"~     The study aims to evaluate effectiveness of ringer injection with or without corticosteroid~     during arthrocentesis of the temporomandibular joint in the treatment of internal derangement~     of the temporomandibular joint (TMJ).~   "
122870|NCT01959217|"~     Medication adherence rates among youth living with HIV are inadequate to effectively manage~     the disease, and novel interventions grounded in basic behavioral sciences are needed. This~     multi-site phased (3 phases) study plans to translate basic cognitive neuroscience regarding~     prospective memory (PM) into a more potent adherence intervention for youth living with HIV~     (YLH).~      The phases are:~      Phase 1: To improve PM in basic laboratory tasks in YLH with and with out substance abuse.~        -  Hypothesis 1: Manipulations in three theory-based components of PM (strategic encoding,~          self-monitoring and cue salience) will improve PM within each participant.~      Phase 2: To conduct proof of concept studies of a text-delivered PM intervention for taking~     ART in YLH with suboptimal adherence.~        -  Hypothesis 2: Using a multiple baseline across subjects design, adherence to ART will~          improve following initiation of the PM adherence intervention and will be maintained for~          6 weeks after tapering of the intervention.~        -  Hypothesis 2a: Similar feasibility, tolerability, and adherence improvement trends will~          be seen in youth with and without substance problems.~      Phase 3: To conduct a pilot randomized clinical trial of the PM intervention compared to~     traditional text message reminders (comparison condition) in non-adherent youth stratified by~     substance use.~        -  Hypothesis 3: Youth randomized to receive the PM intervention will show greater initial~          and sustained improvements in adherence and viral load compared to those randomized to~          the control condition.~        -  Hypothesis 3a: We will explore trends in the data relative to substance abuse, but we~          anticipate that the intervention will show promise for both substance using and non~          substance using YLH warranting a larger clinical trial that can test for~          substance-related mediators and moderators of the intervention.~   "
122871|NCT01959204|"~     The objective of this study is to characterize the pharmacokinetics and to evaluate the~     safety of single and multiple doses of Oxycodone Oral Solution in pediatric and adolescent~     subjects for postoperative pain.~   "
122872|NCT01959191|"~     Objective: To evaluate the early and late prognoses of patients according to platelet~     reactivity after clopidogrel administration and determine whether the measurement of platelet~     inhibition predicted 1-year clinical outcomes after off-pump coronary bypass (OPCAB) Study~     design~        -  Prospective, observational, single-center study~        -  Subjects with OPCAB surgery who meet all inclusion and exclusion criteria will be~          enrolled.~        -  Platelet reactivity after 7-days clopidogrel treatment from the day of surgery will be~          measured by VerifyNow system.~        -  Dual antiplatelet therapy including aspirin and clopidogrel will be administered for 1~          year after surgery and subjects will be followed-up for 1 year about primary endpoint.~        -  Cutoff value of P2Y12 reactivity units (PRUs) for primary endpoint will be assessed and~          the cohort will be divided by the PRU cutoff value (low/high platelet reactivity~          groups).~        -  The primary and secondary endpoints will be compared between two groups~   "
122873|NCT01959165|"~     This is a multi-centre, randomised, double-blind, placebo controlled, parallel group, Phase~     II study to evaluate efficacy and safety of 3 doses of MEDI7183, in Japanese subjects with~     moderate to severe UC~   "
122874|NCT01959152|"~     The purpose of this study is to determine the feasibility of preserving low-frequency~     acoustic hearing in adults with a moderate degree of hearing loss in the low frequencies and~     severe-to-profound hearing loss in the mid-to-high frequencies who are implanted with the~     HiRes™ 90K Advantage implant with HiFocus™ Mid-Scala electrode.~   "
122875|NCT01959139|"~     This partially randomized phase I/II trial studies the side effects and best dose of~     pegylated recombinant human hyaluronidase (PEGPH20) when given together with combination~     chemotherapy and to see how well they work compared with combination chemotherapy alone in~     treating patients with newly diagnosed pancreatic cancer that has spread to other places in~     the body. Pegylated recombinant human hyaluronidase may help chemotherapy drugs work better~     by making tumor cells more sensitive to the drugs. Drugs used in chemotherapy, such as~     leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. It is not yet known whether~     combination chemotherapy is more effective with or without pegylated recombinant human~     hyaluronidase in treating pancreatic cancer.~   "
122876|NCT01959126|"~     The purpose of this research study is to examine whether a stress reduction intervention can~     improve health, mood and biological markers of cellular stress and aging in a group of~     chronically-stressed maternal caregivers and healthy maternal controls.~   "
122877|NCT01959113|"~     Unlike healthy control skin, the skin of patients with atopic dermatitis (AD) is frequently~     colonized by Staphylococcus aureus (S. aureus), putting these patients at increased risk of~     S. aureus skin infections. In addition, research in the investigator's lab has shown that~     these patients have fewer protective antimicrobial Staphylococcal species such as~     Staphylococcal epidermidis (S. epidermidis) that are known to produce antimicrobial peptides~     that play a role in protecting the skin from invading pathogens. In this study, the~     investigator will attempt to decrease S. aureus colonization and increase colonization by~     protective Staph species in AD patients. First the investigator will capture the bacteria on~     subjects' lesional AD skin. Next the investigator will selectively grow the subject's~     antimicrobial Staphylococcal colonies and place them into a base moisturizer. The moisturizer~     plus bacteria will be applied to one of the subject's arms, and the moisturizer alone~     (without bacteria) to the other arm. The investigator will then do a quantitative wash of the~     bacteria growing on each arm one day later in order to determine whether the S. aureus~     abundance was affected by the application of the transplanted bacteria.~   "
122890|NCT01958944|"~     Cystic Fibrosis is defined as a genetic disorder affecting approximately 100,000 individuals~     worldwide. CF is caused by mutations in the CF Transmembrane Conductance Regulator (CFTR)~     gene. CF patients are highly prone to environmental opportunistic bacterial infections~     leading to prolonged and chronic lung infections. This results in reduction in the life~     expectancy of CF patients due to excessive lung tissue destruction.~      Nitric Oxide (NO) is a naturally produced antimicrobial agent which is part of the innate~     immune defense system of the lung. Both in vitro and in vivo studies had shown clearly that~     NO acts against a wide variety of microbes including drug resistant bacteria as well as~     viruses and fungi. Building on a successful phase I safety trial, the team aims to develop a~     combined drug-device strategy to combat lung infections caused by biofilm-forming bacteria.~     Unlike other inhaled drugs, NO is also a smooth muscle relaxant and avoids the concomitant~     bronchial constriction often associated with inhaled antibiotics. An added benefit of NO~     therapy is its mucolytic activity. We suggest that the combine broad spectrum antimicrobial~     activity, signaling and mucolytic properties of NO, delivered to the lungs of CF patients,~     will be directed at reducing bacterial resistance, microbial burden and biofilms as well as~     resulting in improved airway clearance of viscid sputum.~      Primary Objectives: Assess the safety and the tolerability of NO intermittent inhalation~     treatment in ≥10 years old CF subjects. Secondary Objective: Assess the improvement in forced~     expiratory volume in 1 second (FEV1) before and after NO intermittent inhalation. Up to 10~     subjects with Cystic Fibrosis will be enrolled into the study.~      Treatment administration: The subjects will receive intermittent inhalation of NO in addition~     to standard treatment for 10 working days (no NO treatment will be given to the subjects~     during weekend days). The subjects will be asked to attend the CF clinic once a week for a~     period of two weeks in order to evaluate the parameters related to the study. Oxygen (O2),~     NO, nitrogen dioxide (NO2) and fraction of inspired oxygen (FiO2) delivered to the patient~     will be continuously monitored.~   "
122891|NCT01958931|"~     A Study to evaluate the utility of the ProLung Test as an adjunct to CT scan in the diagnosis~     of lung cancer.~   "
122878|NCT01959100|"~     The occurrence of bronchiolitis obliterans syndrome (SBO) after allogeneic hematopoietic stem~     cell transplantation (HSCT) is considered to be a chronic pulmonary graft versus host disease~     (GVHD) that is associated with significant mortality and morbidity. The reported incidence of~     SBO varies from 6 to 26% of allogeneic HSC recipients and is usually diagnosed within 2 years~     after transplantation. The diagnosis of SBO relies on the occurrence of a new airflow~     obstruction identified during pulmonary function testing, and the definition differs between~     studies. Currently, no curative immunosuppressive treatment is available, and recent data~     suggest that the use of these treatments, especially corticosteroids, should be limited~     because of their toxicity. The impairment of lung function parameters is likely caused by~     fibrous small airway lesions. Few data on the pathogenesis of SBO after allogeneic HSCT are~     available. Several hypotheses are based on the occurrence of SBO during chronic graft~     rejection after lung transplantation, which shares many clinical and histopathological~     similarities with SBO after allogeneic HSCT. One hypothesis is that the first step leading to~     SBO is lung epithelium injury. SBO is then identified as an alloimmune reaction with only one~     clearly identified risk factor: extrathoracic chronic GVHD. Due to their anti-inflammatory~     and immunomodulatory properties, recent data suggest that low-dose macrolides may be~     effective at preventing SBO after lung transplants. This well-tolerated treatment may be~     useful for preventing SBO after allogeneic HSCT.~      The objective of this Phase 3 multicentre randomized, double-blinded, clinical trial is to~     evaluate the efficacy of azithromycin in preventing BO syndrome after allogeneic HSCT in~     patients with malignant hematological diseases.~   "
122879|NCT01959087|"~     This study aims to compare the results of colonic surgery performed by single and multiport~     laparoscopy.~   "
122880|NCT01959074|"~     This study is To confirm the efficacy of Naftopidil for reducing discomfort of ureteral stent~     after urinary stone surgery.~   "
122881|NCT01959061|"~     To evaluate the efficacy and safety of Raltitrexed for advanced colorectal cancer~   "
122882|NCT01959048|"~     Clostridium difficile has become one of the leading causes of hospital acquired infections,~     and is associated with increased mortality. Patients with C. difficile associated disease~     (CDAD) possess deficiencies in 'normal' fecal microbial composition, most likely as a result~     of earlier antibiotic usage. The current standard of care treatment for severe C. difficile,~     which consists of antibiotics, does not restore the microbiota. Restoration of the normal~     colonic microbiota by fecal microbiota transplantation (FMT) may enable reversion colonic~     microbial population to a more 'normal'state and lead to cure.~      A few patients develop severe CDAD which may be complicated by adynamic ileus, or toxic~     megacolon. The management in this context is based on limited data, and for some the only~     available option is sub-total colectomy.~      Although FMT is by no means a new therapeutic modality, there is limited information on its~     use for the treatment of acute CDAD, including severe CDAD. Because of the high morbidity and~     mortality associated with treatment of patients with severe CDAD, and because the evidence~     supporting the current recommendations is weak and based upon the demonstration that FMT is~     an effective strategy to re-establish a balanced intestinal microbiota with resultant cure of~     recurrent CDAD, we propose to study the efficacy and safety of FMT for severe CDAD.~      Patients with severe CDAD can be divided into two operational groups; those that have~     diarrhea and those that suffer from adynamic ileus. We propose to apply FMT through~     colonoscopy for all patients because current data suggest that the overall success rate of~     FMT for recurrent CDAD with lower gastrointestinal tract FMT was higher than FMT through the~     upper gastrointestinal tract. In addition, for patients with adynamic ileus and toxic~     megacolon (i.e., the population with the highest CDAD-associated morbidity and mortality),~     intra-colonic FMT administration is the preferred alternative.~   "
122883|NCT01959035|"~     To obtain information on the safety, tolerability and effectiveness of aripiprazole~     once-monthly in a manner consistent with its intended use in everyday clinical practice in~     patients with schizophrenia who completed Study 14724A / NCT01795547.~   "
122884|NCT01959022|"~     This study will assess the effects of the medication doxazosin on sleep in men and women with~     PTSD. Sleep will be measured objectively at home using a portable sleep recorder and wrist~     actigraphy.~   "
122885|NCT01959009|"~     Background:~      Ventilator induced lung injury (VILI) remains a problem in neonatology. High frequency~     oscillatory ventilation (HFOV) provides effective gas exchange with minimal pressure~     fluctuation around a continuous distending pressure and therefore small tidal volume. Animal~     studies showed that recruitment and maintenance of functional residual capacity (FRC) during~     HFOV (open lung concept) could reduce lung injury.~      Open lung HFOV is achieved by delivering a moderate high mean airway pressure (MAP) using~     oxygenation as a guide of lung recruitment. Some neonatologists suggest combining HFOV with~     recurrent sigh-breaths (HFOV-sigh) delivered as modified conventional ventilator-breaths at a~     rate of 3/min. The clinical observation is that HFOV-sigh leads to more stable oxygenation,~     quicker weaning and shorter ventilation. This may be related to improved lung recruitment.~     This has however to our knowledge not been tested in a clinical trial using modern~     ventilators.~      Purpose, aims:~        -  To compare HFOV-sigh with HFOV-only and determine if there is a difference in~          oxygenation expressed as a/A-ratio and/or stability of oxygenation expressed as~          percentage time with oxygen saturation outside the reference range.~        -  To provide information on feasibility and treatment effect of HFOV-sigh to assist~          planning larger studies. We hypothesize that oxygenation is better during HFOV-sigh.~      Methods:~      Infants at 24-36 weeks corrected gestational age already on HFOV are eligible. Patients will~     be randomly assigned to HFOV-sigh (3 breaths/min) followed by HFOV-only or vice versa for 4~     alternating 1-hours periods (2-treatment, double crossover design, each patient being its own~     control). During HFOV-sigh set-pressure will be reduced to keep MAP constant, otherwise HFOV~     will remain at pretrial settings. Outcome will be calculated from normal clinical parameters~     including pulx-oximetry and transcutaneous monitoring of oxygen and carbon-dioxide partial~     pressures.~   "
122886|NCT01958996|"~     R-CHOP with doxorubicin is the standard first line treatment of high grade non-Hodgkin's~     lymphoma. In order to avoid central venous system insertion and reduce hospitalization time~     in elderly patients, we developed an oral chemotherapy treatment:  OROCIEPtrial.~      Nineteen patients were enrolled and 127 chemotherapy cycles were available for toxicities.~     The estimated two-years overall survival was 74%. The main haematological toxicity was~     neutropenia.~      This study is still ongoing to confirm recommended dose of oral anthracycline.~   "
122887|NCT01958983|"~     The purpose of this study is to determine if the effects of music therapy alter emotion and~     cognition performances of individuals with mild to moderate dementia. The music therapy~     intervention protocol is structured by drum improvisation, rhythm imitation, music cognition~     and song discussion. Attentive listening and active participation of the music training~     activities allow participants to utilize their focus of attention and comprehension of~     informational texts. Music therapy intervention is proposed to provide positive stimulations~     on emotion and cognitive functions of individuals with dementia. The results of the present~     study will clarify relationship between the effect of music therapy and the neural substrate~     of music therapy in anatomical and functional brain data obtained from MRI (fMRI).~   "
122888|NCT01958970|"~     This is a pilot study to assess the safety, pharmacokinetics and effectiveness of PINTA 745~     or placebo in treating protein energy wasting (PEW) in patients receiving maintenance~     hemodialysis (MHD).~   "
122889|NCT01958957|"~     The aim of this study is to evaluate the safety of Ginkgolides Meglumine Injection in the~     treatment of ischemic stroke with Syndrome of Intermingled Phlegm and Blood Stasis.~   "
122896|NCT01958866|"~     Hypothesis: Tinospora Crispa-extract Product can reduce pyretic similar to acetaminophen.~      This study aims to investigate the efficacy and safety of Tinospora Crispa-extract product~     compared with the acetaminophen. Total of 96 patients with body temperature between 37.8-38.5~     without any signs of infections will be enrolled in this study. Patients will be randomly~     divided into 3 groups: First group will receive acetaminophen 1000 mg every 6 hr, Second~     group will receive Tinospora Crispa-extract Product 2000 mg twice daily and the third group~     will receive placebo twice daily.~   "
122897|NCT01958853|"~     The purpose of this open label study is to provide up to 24 active treatments of noninvasive~     cortical electrostimulation therapy only to those fibromyalgia patients who experienced~     inadequate pain reduction in a sham controlled double blinded lead in study, NPT-201~     (NCT01825954). The therapy will be provided by the NeuroPoint device using the same protocol~     as that used in active treatment arms of NPT-201. The study's primary outcome measure will be~     the patient's change from baseline in self-reported 24-hour average pain intensity. The study~     will provide active treatment to those participants who received sham therapy in NPT-201, and~     will test whether or not additional therapy applications might further improve pain in those~     participants who previously received active therapy, but did not achieve adequate pain~     relief.~   "
122898|NCT01958840|"~     Following a small, open-label pilot study that yielded very promising results of BATD, the~     current study will consist of a larger, randomized control trial (n=60) that will compare~     BATD to Supportive Counseling in outcomes of depression, contact with positive reinforcement~     in the environment, treatment satisfaction, therapeutic alliance, and perceived stigma. In~     addition, participants' adherence rates to each of the therapies and their maintenance of~     clinical gains at a 1-month follow-up, will be examined.~   "
122899|NCT01958827|"~     The purpose of this study is to investigate the efficacy, safety and pharmacokinetics after~     dose escalation in Japanese subjects with Crohn's Disease.~   "
122900|NCT01958814|"~     randomized double-blind controlled study in parallel groups~      Salbutamol is a β2 mimetic short-acting to be administered by nebulization in this study.~      During this administration, non invasive ventilation for the patient will be continued.~   "
122901|NCT01958801|"~     The aim of this study is to compare the efficacy of supraclavicular and interscalene brachial~     plexus blocks in the patients undergoing arthroscopic shoulder surgery.~   "
122902|NCT01958788|"~     Generalized Anxiety Disorder (GAD) is an anxiety disorder characterized by excessive and~     uncontrollable worry. Our research group has developed a cognitive-behavioural treatment~     (CBT) for GAD centered upon intolerance of uncertainty, a dispositional characteristic that~     arises from a set of negative beliefs about uncertainty and its consequences (Dugas &~     Robichaud, 2007). This CBT protocol has demonstrated good efficacy over four previous~     clinical trials: approximately 70% of participants fully remit from GAD following treatment~     and maintain these gains over extended follow-up periods. These results, while positive, do~     suggest that a substantial minority of individuals do not fully benefit from the existing~     treatment protocol. Across our randomized clinical trials, individuals who do not achieve~     diagnostic remission of GAD continue to endorse elevated levels of intolerance of~     uncertainty. This suggests that the current CBT protocol does not effectively reduce~     intolerance of uncertainty in some treated individuals. To address this, we have developed a~     modified version of the original CBT protocol that targets intolerance of uncertainty more~     directly. The goal of the current proposal is to determine whether this newly developed CBT~     protocol with fewer components can deliver comparable or superior GAD symptom reduction. A~     total of 7 participants with a primary diagnosis of GAD received the newly developed CBT~     protocol over 12 weekly sessions. Measures of GAD symptoms, psychopathology, and intolerance~     of uncertainty were administered at pre-, mid-, and post-treatment, as well as at 3- and~     6-month follow-ups. The proposed study will provide information about the efficacy of this~     new CBT protocol in reducing GAD symptoms.~   "
122903|NCT01958775|"~     1. To assess whether Glucagon like peptide 2 (GLP-2) affects lipoprotein production (study~          A)~        2. To assess whether GLP-2 affects the release of preformed chylomicrons (study B)~   "
122904|NCT01958762|"~     In the Somme region of France, cancer registry data showed an increasing incidence of oral~     cancer. The Incidence Rates in Somme as compared to the national rates for Lip, Oral Cavity~     and Pharynx Cancer were in 2010: 31,4/100 000 Standard population versus 18,2 /100 000 for~     male and 8,2/100 000 versus 5,5/100 000 for female, disaster area where action to improve~     early detection for smokers will be assessed. This target population consults late (as 70% of~     oral cavity cancers are diagnosed at a late stage (T3 or T4). This project is an innovative~     incentive strategy for screening among general practitioners based on unusual information~     vectors (tobacconist, local media).~      The main objective of this study is a screening of oral cavity cancers in tobacco users aged~     30-75 years in the Somme region of France.~   "
122905|NCT01958749|"~     The current standard treatment for chronic tympanic membrane perforations (TMP) involves~     having fat grafted from the patient and inserted into the ear, through the perforation, to~     promote healing using the fat graft myringoplasty (FGM) technique. Platelet rich plasma (PRP)~     has also been used to promote TMP healing and involves having the patient provide a blood~     sample, which is processed to produce PRP and applied to the perforation. This prospective,~     multi-centre study will evaluate whether combining both these techniques can improve the rate~     of closure in patients with chronic TMP involving <50% of the membrane.~      Patients will be randomized to receive either the standard FGM treatment or FGM treatment~     with the addition of PRP. At 3 months postintervention a blinded observer will rate the~     degree of TMP closure. Differences in closure rates between the 2 groups will be compared.~   "
122906|NCT01958736|"~     This pilot study intends to evaluate whether stroke patients can complete ballistic strength~     exercises for thirty minutes, three times per week over a six week training period in~     addition to their existing rehabilitation program.~      It will evaluate whether using ballistic training principles, is superior in improving~     mobility compared with usual care exercises to improve mobility and leg strength in stroke~     patients.~      In this study there will be 15 participants per group, a total of 30 participants. The~     control group will receive usual care consistent with existing rehabilitation practice and~     literature. The experimental group will perform task specific strength training in a~     ballistic fashion.~   "
122907|NCT01958723|"~     The emergence of electronic documentation has led to multiple new challenges for physicians.~     Despite positive expectations, many physicians have received electronic health systems with~     mixed results. Review of current literature has identified the following reasons for concern:~     increased time required for documentation, deteriorating quality of notes, mindless use of~     copy-and-paste functions, and fragmentation of clinical work from poorly designed computing~     workflows. The study of template use has not been done in a large scale or with clear outcome~     measurements. The purpose of this study is to examine the effects of Problem Specific~     Templates on quality, accuracy, and efficiency of physician documentation practices.~   "
122908|NCT01958710|"~     Retrospective analysis of surgery and/or bronchial embolisation for pulmonary aspergilloma.~   "
122909|NCT01958697|"~     Esophagectomy for cancer is often accompanied with severe preoperative weight loss. Body Mass~     Index (BMI) values are age-independent and the same for both sexes. From the perspective that~     these two parameters should actually be taken into account too, we developed a model to~     calculate age-gender specific BMI-percentiles (AG-BMI) and tested this model in relation to~     survival outcome after esophagectomy for cancer.~   "
122910|NCT01958684|"~     To observe the bleeding patterns of post-abortion immediate insertion of IUS compared to~     Cu-IUD over the first 6 months.~   "
122911|NCT01958671|"~     This trial will evaluate the efficacy and safety of ertugliflozin monotherapy in the~     treatment of participants with type 2 diabetes mellitus (T2DM) and inadequate glycemic~     control on diet and exercise. This trial consists of a run-in period of 3 to 11 weeks, a~     26-week placebo-controlled treatment period (Phase A), and a 26-week active treatment period~     (Phase B). The primary hypotheses of the trial are that at Week 26, the mean reduction from~     baseline in hemoglobin A1c (A1C) for 15 mg ertugliflozin is greater than that for placebo and~     the mean reduction from baseline in A1C for 5 mg ertugliflozin is greater than that for~     placebo.~   "
122912|NCT01958645|"~     A study to investigate the safety, tolerability and pharmacodynamics of MEDI8111 after single~     ascending doses in healthy male.~   "
122913|NCT01958632|"~     The actual study should provide a first direct comparison between results after~     reconstruction of sensory nerves of the hand using muscle-in-vein conduits to the standard~     methods of nerve transplantation and direct nerve suture.~   "
122914|NCT01958619|"~     A healthy volunteer study to characterise the exposure of the two study medications,~     following administration of OZ439 + TPGS granules with piperaquine phosphate granules~     (intended for children) and with piperaquine phosphate tablets (intended for adults).~     Ideally, to confirm the exposure demonstrated in an earlier bioavailability study.~   "
122915|NCT01958606|"~     The objective of this study was to compare the effectiveness of high intensity interval~     training (HIT) and traditional aerobic training for persons with stroke.~   "
122916|NCT01958593|"~     This small (pilot) study is designed to provide information on whether the combination of~     psychotherapy with the drug MDMA is safe and helpful for people with post traumatic stress~     disorder (PTSD). The researchers will use the results of this study to design more studies of~     this treatment. The study compares a comparator (placebo) and a full dose. For each session,~     there will be an initial dose possibly followed 1.5 to 2.5 hours later by a dose half the~     size of the initial dose. The study will measure symptoms of PTSD, depression, general~     psychological well-being, sleep quality, feelings that the self or world is unreal~     (dissociation), potentially positive effects of surviving traumatic events and cognitive~     function (thinking, memory and attention). People experiencing pain or tinnitus (ringing in~     the ears) will record their symptoms throughout the study. Seven people will be randomly (by~     chance) assigned to receive full-dose MDMA and five will be randomly assigned to receive a~     comparator. There will be three preparatory psychotherapy sessions before the first~     experimental session, and subjects will have supportive or integrative sessions after each~     MDMA-assisted psychotherapy session. Subjects will meet with a male and female~     psychotherapist for all experimental sessions and for sessions before and after each~     experimental session. Subjects who received comparator can enroll in Stage 2, where they will~     have three open-label MDMA-assisted psychotherapy sessions, meaning everyone will know they~     are receiving an active dose of MDMA. Subjects receiving full dose in Stage 1 will have a~     third experimental session.. Symptoms of PTSD and other symptoms will be measured again at~     least 12 months after each subject has started the study.~   "
122917|NCT01958580|"~     This pilot clinical trial studies gemcitabine hydrochloride, docetaxel, and radiation therapy~     in treating patients with uterine sarcoma that has been removed by surgery. Drugs used in~     chemotherapy, such as gemcitabine hydrochloride and docetaxel, work in different ways to stop~     the growth of cancer cells, either by killing the cells or by stopping them from dividing.~     Radiation therapy uses high energy x rays to kill tumor cells. Giving combination~     chemotherapy with radiation therapy may kill any tumor cells that remain after surgery.~   "
122918|NCT01958567|"~     The main purpose of this study is to describe the optical coherence tomography (OCT) findings~     in eyes with scleral inflammation and to differentiate cases with anterior scleritis from~     those with episcleritis and normal controls.~   "
122919|NCT01958554|"~     Intimate partner violence (IPV) against women have negative mental health consequences for~     survivors; interventions designed to improve survivors' depressive symptoms and health status~     are limited.Present study evaluate the effectiveness of an integrated intervention in~     reducing intimate partner violence (IPV) improving health status.~   "
122920|NCT01958541|"~     This study investigates the impact of brief behavioral insomnia treatment on depressive~     symptoms among military veterans.~   "
122921|NCT01958528|"~     This is a prospective study to collect blood and bone marrow samples from patients with SM~     and MGUS. About 100 subjects will be enrolled at the University of Pennsylvania and followed~     for 2 years. The primary objective of this study is to evaluate CMMCs as a biomarker to~     detect patients at high risk of progression to multiple myeloma in patients with MGUS and~     SMM.~   "
122948|NCT01958177|"~     Cerebellar ataxia is a complex motor disturbance, which, can occur as a result of many~     diseases and presents with symptoms of an inability to coordinate balance, gait, extremity~     and eye movements. Lesions to the cerebellum can cause dyssynergia, dysmetria,~     dysdiadochokinesia, dysarthria and ataxia of stance and gait. Deficits are observed with~     movements on the same side of the body as the lesion (ipsilaterally).~   "
122922|NCT01958515|"~     The primary purpose of this research is to investigate anti-tumor immune responses in~     patients undergoing chemotherapy and radiation for Head and Neck Cancers.~      Hypothesis: Treatment of HPV-associated OPSCC with concurrent chemoradiation results in~     changes in the tumor microenvironment. We hypothesize that these changes during daily~     fractionated chemoradiotherapy can lead to detectable changes in HPV-specific tumor immune~     responses.~      Hypothesis: HPV-specific cellular immune responses can still be detected during radiotherapy~     in the presence or absence of lymphopenia.~        -  This study will determine whether specific anti-tumor immune responses (Specific~          Antibodies and Specific T-cells) can be detected in patients undergoing chemoradiation~          treatment for Head and Neck Cancers.~        -  This study will evaluate the presence or absence of HPV (human papillomavirus) specific~          immune responses before, during, and after treatment for Head and Neck Cancers.~        -  This study will also evaluate whether decreased white blood cell counts may affect~          development of immune responses in Head and Neck cancer patients undergoing treatment.~      Any head and neck cancer patient undergoing concurrent chemoradiotherapy is eligible if: you~     are older than 18 years of age, capable of providing informed consent, have a life expectancy~     of greater than 4 months, and have a good performance status.~      You are eligible irregardless of your HPV positive or negative status. People with HPV~     positive (human papillomavirus associated) head and neck cancer may join. People with HPV~     negative head and neck cancer may also join.~   "
122923|NCT01958502|"~     Because the rate of non union of long bone in lower extremities specially in tibia in this~     two last decade due to malnutrition and smoking and other risk factors was increased, so many~     patient in our country suffer from non union. On the other hand it seems that the use of the~     mesenchymal stem cells can irritate the union rate. Also for better result we used the~     mesenchymal stem cells with BMP2 in collagenic scaffold. The collagen has a osteoconductive~     effect and BMP2 and stem cells has a osteoinductive effect therefore this combination is~     useful in filling the gap in non union site and irritate the union rate.~      Mesenchymal stem cell derived from iliac bone marrow after centrifuge with ficoll procedure.~     Then the investigators will follow the patient with monthly radiography and evaluate the~     callus volume and clinical union and any side effect of this treatment. Clinical union~     consider to relief pain in non union site and be stable in examination.~   "
122924|NCT01958489|"~     The main purpose of this study is to look at the effect of evacetrapib on pravastatin levels~     in the blood when both drugs are taken at the same time. The study will also assess how well~     the body handles evacetrapib and pravastatin when given at the same time.~      This study has two periods in fixed order. Each participant will enroll in both periods. This~     study will last approximately 25 days, not including screening.~   "
122925|NCT01958476|"~     1: SPECIFIC AIM I: To compare treatment options for neonatal abstinence syndrome (NAS) due to~     in-utero narcotic exposure. One hundred eighty four full-term infants with a diagnosis of NAS~     requiring medications will be studied. Infants will be randomized to receive either morphine~     or methadone. It is hypothesized that morphine treated infants will do better and require~     fewer days in the hospital compared to methadone treated infants.~      2. SPECIFIC AIM II: To evaluate the effects of NAS treatment on long-term neurodevelopmental~     outcome. Infants will be evaluated with development testing at 18 months of age. It is~     hypothesized that morphine treated infants will have better neurodevelopmental outcomes. It~     is also hypothesized that neurobehavioral abnormalities identified at two weeks of age will~     correlate with neurodevelopmental impairment at 18 months.~      3: SPECIFIC AIM III: To determine if common genetic variations in the genes involving~     narcotic action contribute to the severity of NAS. A DNA sample will be obtained from all~     infants and analyzed for differences in 3 key genes. This will then be correlated with~     short-term and long-term outcomes.~   "
122926|NCT01958463|"~     Recent data have demonstrated beneficial health outcomes of microbiota transplantation for~     the treatment of Clostridium Difficile infection.~      The investigators propose testing whether fecal transplantation from a healthy donor can lead~     to a recovery from Clostridium Difficile recurrent/treatment-resistant infection.~   "
122927|NCT01958450|"~     Compare the efficacy of frational Er:YAG laser and that of bipolar frequency with diode laser~     treatment.~   "
122928|NCT01958437|"~     Remembering how to travel from one location to another is critical in everyday life, yet this~     vital ability declines with normal aging and can be further affected by conditions that~     disproportionately affect the elderly, such as vision loss or progressive dementia. Human and~     animal research has shown that two distinct memory systems interact during navigation. The~     first, referred to as allocentric navigation, is very flexible and uses spatial knowledge of~     key features or landmarks to develop and use a mental map of the environment. This approach~     involves brain regions that are critical for new learning and memory but that decline with~     age. The second, referred to as egocentric navigation, is inflexible and relies on habit~     memories that link specific features with specific directions. This approach relies on brain~     regions that are critical for automatic responses and that are relatively unaffected by~     age.~      The main problem is that allocentric navigation declines with age and is accompanied~     increased dependence on egocentric navigation. This change increases the risk of becoming~     disoriented or lost when traveling in unfamiliar areas or even when traveling new routes in~     familiar areas. Therefore, the main goal of this project is to examine whether non-invasive~     brain stimulation, specifically transcranial direct current stimulation, can improve~     allocentric navigation in healthy older adults and patients with mild cognitive impairment.~      Participants will complete two functional magnetic resonance imaging sessions while learning~     new environments. Before one of these sessions, participants will receive active brain~     stimulation over the parietal cortex. Before the other session, participants will receive~     sham brain stimulation over the parietal cortex. The effects of this stimulation will be~     evaluated using both an allocentric and an egocentric memory test. Physiologic effects will~     be evaluated using both task-based and resting-state MRI.~   "
122929|NCT01958424|"~     The purpose of this study is to examine the effect of metabolic syndrome in over-weight women~     on IVF treatment outcomes.~   "
122930|NCT01958411|"~     -  Vascular inflammation is a key factor in both the pathogenesis and outcome of~          atherosclerosis. 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a~          promising tool for identifying and quantifying vascular inflammation within~          atherosclerotic plaques.~        -  Non-alcoholic fatty liver disease (NAFLD) is closely associated with many~          cardiometabolic risk factors. NAFLD can be detected by measuring liver fat accumulation~          using computed tomography (CT).~        -  Also epicardial adipose tissue (EAT) volume as determined by computed tomography (CT) is~          an independent marker of cardiovascular events in the general population.~        -  Therefore, the purpose of this investigators study is to compare the NAFLD severity and~          EAT volume with FDG uptake measured by PET/CT.~   "
122949|NCT01958164|"~     This is a multicentre, open-label, randomised, phase III study designed to evaluate the~     efficacy and safety of Actilyse 2 mg/2 ml in the restoration of function of CVAD~   "
122931|NCT01958398|"~     Objectives: This study evaluates the efficacy of two mobile phone applications, Promillekoll~     and PartyPlanner among university government members at two universities in Stockholm,~     Sweden. The design is a three-armed randomized controlled design, and outcomes are measured~     in terms of changes in problematic alcohol use at follow up 7 weeks after study initiation~     and baseline data gathering. Both the Promillekoll and PartyPlanner apps feature real time~     registration of alcohol consumption and giving feedback of estimated blood alcohol~     concentration levels. Both apps inform and warn the user when the estimated alcohol level is~     above 0.6%, a level set that is below risky consumption levels. PartyPlanner additionally~     provides the possibility of simulating and planning an alcohol consumption event in advance~     and later on comparing it with the real time registration at the event.~      Method: Participants with problematic alcohol use (AUDIT >7 for men and >5 for women) are~     randomized into one of three groups: 1. Access to Promillekoll, 2. Access to PartyPlanner and~     3. Control group. Outcomes on alcohol use as well as information on the users' satisfaction~     with the app assigned to them gathered after 7 weeks.~      The hypotheses are: 1. The groups receiving the Promillekoll and PartyPlanner interventions~     will reduce their alcohol use to a larger extent than the control group at follow-up compared~     to the baseline level. 2. The addition of the possibility to plan events beforehand~     (PartyPlanner) will lead to an increased decrease in alcohol consumption to only real-time~     use (Promillekoll).~   "
122932|NCT01958385|"~     This is a multicenter, randomized, evaluator and subject blinded, parallel-group, controlled~     study intended to evaluate the safety and efficacy of treating obese patients with the~     placement of g-Cath EZ suture anchors followed by a structured diet and exercise plan as~     compared to a sham procedure followed by the same diet and exercise plan. Subjects will be~     randomly assigned in a 2:1 ratio to the treatment procedure followed by diet and exercise or~     the sham procedure followed by diet and exercise. After un-blinding at 12 months~     post-treatment, sham patients can choose to have the treatment procedure as well.~   "
122933|NCT01958372|"~     This phase I trial studies the side effects of soy isoflavones when given together with~     radiation therapy and chemotherapy in treating patients with stage IIIA-IIIB non-small cell~     lung cancer. Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in~     chemotherapy, such as cisplatin, pemetrexed sodium, and etoposide, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Soy isoflavones may help radiation therapy, cisplatin, pemetrexed sodium, and~     etoposide work better by making tumor cells more sensitive to the drug. Soy isoflavones may~     also protect normal cells from the side effects of radiation therapy and chemotherapy.~   "
122934|NCT01958359|"~     Objectives: The study evaluates the efficacy of two automated telephony, also known as,~     Interactive Voice Recognition (IVR) interventions, Short IVR and Therapeutic IVR. The Short~     IVR works as an interactive alcohol diary where the user is contacted once a week for four~     weeks to register their alcohol consumption during the preceding week. The user is given~     feedback on changes in alcohol consumption compared to last week. The Therapeutic IVR~     contacts the user once a week for four weeks and is also available for user-initiated calls~     24/7 during this four-week period. The Therapeutic IVR allows the user to traverse a menu~     where the user chooses among listening to vignettes and doing exercises with the purpose of~     looking at alcohol consumption and exploring ways of coping with it.~      Method: The design is a three-armed randomized controlled design, and outcomes are measured~     in terms of changes in problematic alcohol use at follow up six months after study initiation~     and baseline data gathering. Participants with problematic alcohol use (AUDIT >7 for men and~     >5 for women) are randomized into one of three groups: 1. Short IVR, 2. Therapeutic IVR and~     3. Control group. Outcomes on alcohol use as well as information on the users' satisfaction~     with the intervention are assessed after 6 months.~      The primary hypothesis for this study is that having access to one of the two IVR~     interventions will lead to a greater reduction of problematic alcohol use compared to~     controls who undergo only screening and follow-up assessment. The secondary hypothesis is~     that having access to either Short IVR or Therapeutic IVR leads to comparable reductions in~     risky drinking.~   "
122935|NCT01958346|"~     We propose the additional technique of lingual traction or tongue pulling in conjunction~     with use of the flexible fiberoptic bronchoscope for facilitating successful first attempts~     at and decreasing time to intubation of the difficult airway and rescuing otherwise failed~     intubation attempts. Induction of general anesthesia causes relaxation and approximation of~     the soft palate, base of the tongue, epiglottis, and posterior pharyngeal wall, creating~     unfavorable anatomic changes in the pharynx for successful intubation. The use of lingual~     traction can assist in diminishing these problems by clearing the tongue away from the soft~     palate and uvula and lifting the epiglottis from the posterior pharyngeal wall, especially in~     the unanticipated difficult airway patient.~   "
122936|NCT01958333|"~     The purpose of this study is to investigate the effects of three different exercise programs~     (e.g. low-intensity, medium-intensity, high-intensity) administered for six months on~     health-related physical fitness, biochemical variables and general health outcomes in~     high-risk employees, with about 2000 volunteers will participate in the randomized and~     repeated-measure study.~   "
122937|NCT01958320|"~     The primary goal of the trial is to compare two different Patent Ductus Arteriosus (PDA)~     treatment approaches: 1) an early treatment approach or 2) a conservative approach. For~     the purposes of the study infants will be enrolled if they are delivered before 28 weeks~     gestation and have a moderate/large PDA present at 5-7 days after birth.~      The hypothesis is: treatment of a moderate size patent ductus arteriosus (PDA) will decrease~     the time needed for assisted respiratory support, diuretic therapy, and gavage feeding~     assistance, in addition to decreasing the incidence of ductus ligations or need for future~     outpatient cardiology follow-up appointments. The investigators hypothesize that one or more~     of these benefits will occur without an increase in the time taken to achieve full enteral~     feedings or in the incidence of necrotizing enterocolitis (NEC) or spontaneous intestinal~     perforations (SIP).The investigators will be comparing the effectiveness of early~     pharmacologic treatment with a control group of conservatively managed infants who will only~     receive treatment if they meet specific criteria for rescue treatment.~   "
122983|NCT01957709|"~     This pilot clinical trial studies the effect of recombinant interferon gamma on tissue in~     treating patients with soft tissue sarcoma. Interferon gamma may interfere with the growth of~     tumor cells.~   "
122938|NCT01958307|"~     Multicenter and multidisciplinary public health project in 10 regions of Bavaria, a federal~     state of Germany, targeting maternal and fetal health. The objective of this trial is to~     evaluate the efficacy of a lifestyle intervention program focusing on diet, physical activity~     and weight monitoring during pregnancy. The intervention comprises 4 individual counseling~     sessions addressing healthy living. Primary outcome: gestational weight gain. Secondary~     outcomes are pregnancy and obstetric complications like gestational diabetes and rate of~     caesarean sections as well as offspring health.~      The lifestyle intervention program is adapted to the German health care system to allow an~     immediate implementation after successful evaluation.~   "
122939|NCT01958294|"~     The LOTUS Study is intended to demonstrate the usability of the MICHI Neuroprotection System~     (MICHI NPS) or MICHI Neuroprotection System with filter (MICHI NPS+f) for use in subjects who~     are candidates for Carotid Artery Stenting (CAS). It is a prospective, single arm study in~     which a maximum of 30 study subjects, and a run-in enrollment of up to 10 subjects will be~     followed immediately post-op and at 30 days.~   "
122940|NCT01958281|"~     This study will evaluate the safety, tolerability and antiviral efficacy of sofosbuvir (SOF)~     with ribavirin (RBV) in participants with GT 1 and 3 and ledipasvir (LDV)/SOF in participants~     with genotype 1 and 4 HCV infection who have chronic renal insufficiency (impaired kidney~     function).~      Approximately 35 subjects with severe renal insufficiency (not on dialysis) will be enrolled~     in 3 cohorts.~        -  Cohort 1 (GT 1 or 3): 10 subjects will receive SOF 200 mg + RBV 200 mg once daily for 24~          weeks.~        -  Cohort 2 (GT 1 or 3): Following review of safety, efficacy and pharmacokinetics (PK)~          data through post-treatment Week 4 of Cohort 1, 10 additional subjects will receive SOF~          400 mg + RBV 200 mg once daily for 24 weeks.~        -  Cohort 3 (GT 1 or 4): Following review of safety and available PK data through Week 12~          of Cohort 2, 15 additional subjects will receive LDV/SOF 90/400 mg once daily for 12~          weeks.~   "
122941|NCT01958268|"~     Establishment of a questionnaire in German to determine in a structured and quantifiable~     manner the quality of life of patients with dysphagia.~   "
122942|NCT01958255|"~     The aim of this project was to provide tobacco cessation services to the women at the~     community level at their door steps and thus establish a model community based tobacco~     cessation programme which could be replicated in other communities and could be taken up by~     National Tobacco Control Programme (NTCP), in future.~   "
122943|NCT01958242|"~     Blood transfusions after pediatric heart surgery is a relatively common practice occurring in~     up to 46% of patients, however its use has been associated with increased morbidity. In the~     pediatric population undergoing heart surgery transfusion of homologous blood is usually~     required due to the mismatch between the priming volume of the cardiopulmonary bypass circuit~     and the patients own blood volume. Several strategies have been proposed in order to minimize~     the use of blood products. The effect of pre-operative harvest of fresh whole blood in the~     adult population has shown a beneficial platelet protective effect, however concerns have~     been risen that the amount of volume needed in order to sequester a significant amount of~     platelets would be prohibit ally high in a cardiac surgical patient. Fresh blood harvesting~     has not been evaluated in the pediatric population.~      The purpose of the present study would be to evaluate the safety and efficacy of~     pre-operative blood harvesting in the pediatric population undergoing open heart surgery.~     Fresh whole blood will be harvested from the patient prior to the initiation of~     cardiopulmonary bypass and will be returned to the patient after the discontinuation of CPB~     prior to the administration of prominent. Parameters that will be evaluated will include,~     patient characteristic, operative and post-operative parameters, coagulation profiles and the~     use of postoperative blood products.~   "
122944|NCT01958229|"~     This study is designed to support the optimal use of telbivudine by providing data to refine~     our understanding of telbivudine efficacy and resistance in real life clinical setting in~     patients with chronic hepatitis B with defined baseline characteristics and 24-week PCR~     negativity.~   "
122945|NCT01958216|"~     So far, the liver has been the main target for cholesterol elimination. However, several~     recent studies performed in mice have described a new route of cholesterol excretion, the~     Trans-Intestinal Cholesterol Excretion or TICE. TICE allows direct elimination of plasma~     cholesterol in the feces directly via the intestine. Until now, only indirect evidence~     suggests that TICE is also active in humans, the goal of this proof of concept study is to~     provide the first proof of its existence in humans by using stable isotopes in patients with~     bile duct diversion.~   "
122946|NCT01958203|"~     Study Title:Assessment of Adherence to Guidelines for Thromboprophylaxis in a Tertiary United~     Arab Emirates (UAE) hospital~      Study Site: Al Qassimi Hospital, United Arab Emirates~      Study Objectives:~      The primary objective of this study is assessment of appropriateness of VTE prophylaxis~     administered to critically ill and surgical patients for whom pharmacologic treatment is~     indicated according to the American College of Chest Physicians (ACCP) 2012 guidelines.~      The secondary objective is to:~      1.Identify some causes of inadequate VTE prophylaxis in different patient populations, such~     as prescribing problems and errors at the level of administration.~      Study Design: Cross sectional retrospective observational study~      Sample size: Approximately 400~      Study Population:~      Inclusion criteria~      Patients who meet the following criteria will be included:~        1. Patients aged 18 and above.~        2. Patients admitted to any of the critical care units, or the general or orthopaedic~          surgical wards.~        3. Patients who have been in hospital more than 24 hours.~        4. Caprini score > 1 (see procedure)~      Exclusion criteria~      Patients with any of the following criteria will be excluded:~        1. Patients who have been admitted to a critical care unit and transferred out to a non~          surgical unit within 24 hours of admission.~        2. Patients receiving oral anticoagulant therapy for indications other than VTE prophylaxis~          or treatment, such as atrial fibrillation and prosthetic heart valves.~      Study Outcome Measurements:~      The main outcome measure of interest is to determine the proportion of patients who have~     received inappropriate or inadequate VTE prophylaxis considering their calculated risk factor~     compared to the recommended prophylactic measures for that risk.~      Secondary outcome measures are to identify whether there is inadequate VTE prophylaxis~     because of medication errors such as missed doses or wrong doses given.~      Study Duration: 4 months~      Statistical Analysis Data was entered into Microsoft Excel® and subsequently checked to~     ensure accurate data entry and correct any errors. It was subsequently exported into SPSS~     version 20 where it will be analysed.Quantitative data such as age was expressed mean (±~     standard deviation). Categorical data such as gender, risk factors for bleeding, type of~     mechanical and pharmacologic prophylaxis, missed doses and wrong doses were expressed as~     number and percentage of population.The student's t-test was used to analyse parametric data.~     The Pearson Chi-Square Test and Wilcoxon Rank sum test were used to analyse non parametric~     data. Simple and multiple logistic regression analysis was done to identify factors that are~     associated with inappropriate VTE prophylaxis. Factors that were included in the analysis~     included: age, type of admission (medical or surgical), area of admission (critical care,~     general surgery, orthopaedic surgery), Caprini score, and inappropriate VTE prophylaxis as~     the outcome. A p-value of less than 0.05 was be considered statistically significant.~   "
122947|NCT01958190|"~     In this study we compare long term renal function in liver transplantation recipients treated~     with standard dose extended-release tacrolimus alone and recipients treated with a~     combination of low dose extended-release tacrolimus and low dose sirolimus. The hypothesis is~     that the patients treated with the combination have better long term renal function than the~     patients treated with standard dose tacrolimus alone.~   "
122950|NCT01958151|"~     Colonoscopy is an outpatient procedure performed frequently as a screening test for diagnosis~     and treatment of a wide range of gastrointestinal problems. It is often viewed as an invasive~     procedure with the potential for embarrassment, discomfort, and worry. Such fears can result~     in anxiety that may decrease the tolerance and cooperation of the patient, limit the success~     of the procedure, and increase the likelihood of complications. Therefore, colonoscopy is~     frequently performed under sedation. The anxiety level of the patient before the procedure~     may increase the requirement for sedation. It is important for the anesthesiologist to~     predict the effective dosages of sedation before the procedure to ensure rapid and~     comfortable sedation as well as prompt recovery and discharge of the patient.~      This prospective cohort study is planned to evaluate the effects of pre-procedural anxiety~     level on the dose of propofol needed for patient and surgeon satisfaction during colonoscopy.~   "
122951|NCT01958138|"~     The study will be done in pediatric population by comparing two techniques of Laryngeal Mask~     Airway (LMA) removal under the deep anesthesia.~      The both study techniques will be compared on the basis of smooth Laryngeal Mask Airway~     removal, emergence time and the duration of recovery room stay.~   "
122952|NCT01958125|"~     The study will look at a non-invasive treatment for people suffering with chronic and~     episodic headaches. Study subjects will be randomized to an active treatment or an in-active~     treatment for 2 weeks. After the 2 weeks all subjects will continue to treat with an active~     treatment for an additional 2 weeks.~   "
122953|NCT01958112|"~     This research study is evaluating the combination of two drugs called GSK1120212 (trametinib)~     and GSK2141795 as a possible treatment for recurrent or persistent cervical cancer.~     Trametinib and GSK2141795 are drugs that may stop cancer cells from growing. Trametinib is a~     MEK inhibitor - it blocks a protein called MEK that is commonly overactive in tumor cells.~     GSK2141795 is an AKT inhibitor which blocks a pathway in cancer cells that is commonly~     overactive in tumor cells called the PI3kinase pathway. In this research study, the~     investigator is looking to see whether the combination of Trametinib and GSK2141795 is useful~     in treating recurrent and persistent cervical cancer.~      Additionally, the investigator is looking to see if participants whose tumors contain a~     particular genetic make-up will have better response to combination trametinib and~     GSK2141795. Participants' tumors will be tested for mutations in genes which could make some~     cancers more susceptible to trametinib and GSK2141795.~   "
122954|NCT01958099|"~     The purpose of this project is to compare the costs, ability to effectively screen and~     distribute relevant safety information, and assess products purchased and behavior changed by~     families after meeting with an injury prevention specialist compared to using a computerized~     emergency department kiosk. There will be a significantly greater reported practice of safety~     behaviors by families who visit a pediatric emergency department after using a computerized~     kiosk for injury screening and providing tailored recommendations than when the prevention~     information is provided by an injury prevention specialist.~   "
122955|NCT01958086|"~     The investigators objective is to run human clinical trials in which brain activity recorded~     through a brain-chip implanted in the human brain can be used to provide novel~     communication capabilities to severely paralyzed individuals by allowing direct brain-control~     of a computer interface. A prospective, longitudinal, single-arm early feasibility study will~     be used to examine the safety and effectiveness of using a neural communication system to~     control a simple computer interface and a tablet computer. Initial brain control training~     will occur in simplified computer environments, however, the ultimate objective of the~     clinical trial is to allow the human patient autonomous control over the Google Android~     tablet operating system. Tablet computers offer a balance of ease of use and functionality~     that should facilitate fusion with the BMI. The tablet interface could potentially allow the~     patient population to make a phone call, manage personal finances, watch movies, paint~     pictures, play videogames, program applications, and interact with a variety of smart~     devices such as televisions, kitchen appliances, and perhaps in time, devices such as robotic~     limbs and smart cars. Brain control of tablet computers has the potential to greatly improve~     the quality of life of severely paralyzed individuals. Two subjects will be enrolled, each~     implanted with the NCS for a period of 53 weeks. The study is expected to take two years in~     total.~   "
122956|NCT01958073|"~     The investigators would like to know if the use of vaginally applied estrogen can prevent the~     problem of repeated urinary tract infections (UTI) in women who have gone through menopause.~     The investigators will use two forms of vaginal estrogen that are available by prescription~     (a ring and a cream) and compare their efficacy to that of a placebo (without any active~     ingredient). The investigators are going to look at if the vaginal estrogen can prevent UTIs~     altogether and also the number of UTIs each group experiences over a 6 month period. After 6~     months, all subjects will receive vaginal estrogen and the women on the non-active treatment~     will be randomized to either the estrogen ring or cream. The investigators will then be able~     to compare the number of UTIs on and off active vaginal estrogen treatment within those~     subjects who started on the placebo. The investigators are also going to look at quality of~     life before and during treatment using questionnaires and whether subjects stop using the~     treatments or do not use them as directed (compliance).~   "
122957|NCT01958060|"~     Investigation of safety and tolerability of BI 1034020 in healthy male volunteers following~     intravenous (IV) infusion of subcutaneous (SC) injection of single doses and exploration of~     the pharmacokinetics and pharmacodynamics of BI 1034020 after single dosing and determination~     of the bioavailability of subcutaneous injections of BI 1034020~   "
122958|NCT01958047|"~     This study investigates how ASP3652 is taken up, broken down, and distributed through the~     body and excreted in individuals of different races. The study also investigates levels of~     biochemical markers in the bloodstream, and determines how safe the study drug is and how~     well it is tolerated after dosing. A further aim is to look at how the processes of~     metabolism, distribution and excretion of the study drug are possibly altered by the daily~     diet of the volunteers taking part.~   "
123011|NCT01957345|"~     The primary purpose of the study is to evaluate a standardized method of screening for~     platelet signalling defects in patients with constitutional disorders of platelet function of~     unknown origin. We hypothesize that such defects are under-diagnosed in patients, due to~     heavy workup and requirement of relatively large blood sample by conventional biochemical~     methods. We propose to analyse kinase signalling downstream platelet membrane receptors using~     multiplex flow cytometry quantification and fluorescent platelet barcoding.~   "
122959|NCT01958034|"~     In a double blinded, randomized, clinical trial of patients suffering from STEMI (ST-segment~     elevation myocardial infarction) or non-STEMI (non-ST-segment elevation myocardial~     infarction)compare the effect of 3 months of dietary supplement with bilberry extract on a~     range of parameters with prognostic importance in cardiovascular disease: lipids,~     inflammation, oxidative stress and heart function.~      Following inclusion of 8 individuals and as of February 12, 2014: Due to intolerance to~     bilberry placebo powder we have amended to the protocoll that the trial design is changed~     from blinded to open and that the bilberry arm of the trial carries on in an open design and~     that the control group will receive no dietary supplement.~   "
122960|NCT01958021|"~     This is a multi-center, randomized, double-blinded, placebo controlled trial.~   "
122961|NCT01958008|"~     The main objective of the current trial is to investigate safety, tolerability and~     pharmacokinetics of BI 113608 in COPD patients with symptoms of chronic bronchitis.~   "
122962|NCT01957995|"~     This randomized phase I trial studies the side effects and best dose of nanosomal docetaxel~     lipid suspension in treating patients with advanced solid tumors. Drugs used in chemotherapy,~     such as nanosomal docetaxel lipid suspension, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing.~   "
122963|NCT01957969|"~     The aim of this observational study is to evaluate the utilization in the clinical practice,~     effectiveness, explantation and re-intervention rate, complications and adverse events of~     InterStim system in patients indicated to Sacral Neuromodulation therapy for fecal~     incontinence.~      This study will provide additional data about safety and effectiveness of the usage of~     InterStim system in fecal incontinence environment and at the same time will confirm that~     results from clinical trials can be transposed to clinical practice.~   "
122964|NCT01957956|"~     This pilot clinical trial studies vaccine therapy and temozolomide in treating patients with~     newly diagnosed glioblastoma. Vaccines made from a person's white blood cells mixed with~     tumor proteins may help the body build an effective immune response to kill tumor cells.~     Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth~     of tumor cells, either by killing the cells or by stopping them from dividing. Giving vaccine~     therapy and temozolomide may be an effective treatment for glioblastoma.~   "
122965|NCT01957943|"~     The study Aims to investigate the possible beneficial impact of peri-operative or~     post-operative administration of Omega 3 enriched lipid emulsions on recipients for living~     donor liver transplantation.~   "
122966|NCT01957930|"~     We aim to investigate the relationship between skin microvascular function and the first~     hospitalization for ischemic foot ulcer in patients with type 1 diabetes former randomized~     during 7.5 years to intensified conventional insulin treatment (ICT) compared to standard~     insulin treatment (ST).~   "
122967|NCT01957917|"~     The importance of good nutrition and food security among people living with HIV infection~     (PLHIV) is widely recognized. In resource-constrained settings, food insecurity is~     increasingly recognized as an important barrier to retention in care and adherence to~     antiretroviral therapy (ART). However, there are few studies demonstrating that food and~     nutrition assistance programs can improve HIV-related outcomes. This study will address this~     gap by comparing the effectiveness of three models for short-term support for PLHIV. Food~     insecure women and men on ART will be randomized into one of three groups: 1) nutrition~     assessment and counseling (NAC) alone, 2) NAC plus food assistance, or 3) NAC plus cash~     transfers. The investigators will compare the effect of the three approaches on ART adherence~     and retention in care after 6, 12, and 24-36 months of follow-up. The investigators~     hypothesize that NAC plus short-term support in the form of food or cash assistance will~     result in better adherence to ART and retention in care than NAC alone, and that the effects~     of NAC plus food assistance will be the same as NAC plus cash assistance. The results from~     the study will provide evidence about which assistance modalities for PLHIV work best to~     improve ART adherence and retention in care, and under what conditions. This study will be~     conducted in Shinyanga Region, Tanzania, where approximately 17 percent of households have~     poor or borderline food consumption and 7.4 percent of people are living with HIV infection.~   "
122968|NCT01957904|"~     The study is designed to confirm the acute safety and performance of the ArterX® Surgical~     Sealant as a hemostatic agent. The study will collect data in support of publications and~     future product labeling revisions, to provide additional clinical information on use and~     further details regarding product safety.~   "
122969|NCT01957891|"~     The purpose of the study is to assess the effect of progressive, incremental hypoxia at~     multiple wavelengths of light.~   "
122970|NCT01957878|"~     Human Papillomavirus (HPV) 16 and HPV 18 (the two virus genotypes targeted by the ProCervix~     vaccine) are the most common HPV genotypes associated with at least 70% of squamous cell~     carcinomas and 82% of adenocarcinomas of the cervix The strategy of therapeutic vaccination~     with ProCervix is to activate and enhance the patient's cellular immune response to HPV . The~     therapeutic vaccine will be used for women infected by HPV 16, HPV 18, or both. The vaccine~     targets these HPV infected women with normal or mild cervical cellular dyskaryosis as~     detectable infections with oncogenic potential.~      This will be a double-blind, randomised, placebo-controlled, parallel group study assessing~     the efficacy of ProCervix or placebo (concomitantly administered with imiquimod cream).~      ProCervix will be delivered with a topical agent, imiquimod, applied to the injection sites~     as a vaccine adjuvant.~      The population proposed for this study represents an otherwise healthy female population who~     are infected with HPV 16 and/or HPV 18. The safety and tolerability of this therapeutic~     vaccine has been shown in the ongoing Phase I study, and the proposed population may in~     theory derive benefit from this vaccine.~   "
122971|NCT01957865|"~     Development of Real-Time Antiretroviral Therapy Adherence Intervention in Uganda (The~     Wisepill Study).~   "
123024|NCT01957176|"~     This study will provide continued access to treatment with eltrombopag for subjects who are~     currently participating in a GlaxoSmithKline (GSK) sponsored investigational study of~     eltrombopag (parent study) and to collect long term safety data.~   "
123231|NCT01954485|"~     This study aims to demonstrate the histological differences in the connective tissue~     surrounding laser-treated abutments and untreated abutments in humans.~      Working hypothesis: There are differences in the adhesion of collagen fibres around implant~     abutments with laser-produced microgrooves and standard abutments.~   "
122972|NCT01957852|"~     Introduction~      Modern treatment of peritoneal carcinomatosis (PC) combines an aggressive cytoreductive~     surgery (CRS) of all macroscopic disease and hyperthermic intraperitoneal chemotherapy~     (HIPEC) performed at the time of surgery. It is considered a high risk procedure and~     post-operative intra-abdominal bleeding is a major issue as it can delay recovery and promote~     intra-abdominal infections. In most severe cases (10 to 20% of patients), a second surgery to~     control the bleeding will be necessary. Major causes of bleeding are : radical resection,~     extensive peritonectomy, length of surgery, massive transfusion and use of HIPEC.~      To reduce the risk of intra-abdominal hemorrhage, many strategies have been tried and one of~     these is the liberal use of FloSeal, but there is no data in this particular field of~     interest. Over the last 18 months, the investigators have started to use FloSeal in all their~     cases with large PC and they have observed a dramatic reduction in the rate of reoperation~     for bleeding and probably secondarily, in the use of blood products, but this has not been~     measured.~      Hypothesis~      FloSeal can reduce the risk of bleeding after CRS and HIPEC procedure.~      Primary objective~      To evaluate if the use of FloSeal can reduce the risk of reoperation after CRS and HIPEC~     procedure in the treatment of PC.~      Secondary objectives~        -  To evaluate if the use of FloSeal can reduce operative blood loss.~        -  To evaluate if the use of FloSeal can reduce the need of blood products after CRS and~          HIPEC procedure.~        -  To evaluate if the use of FloSeal can have an impact on other common surgical~          complications (which can be indirectly bleeding related).~        -  To evaluate if the use of FloSeal can have an impact on length of hospital stay.~   "
122973|NCT01957839|"~     the investigators examined the hypothesis that hyperprolactinemia may alter uterin,~     endometrial and intraovarian blood flow and may contribute to increased infertility by~     another way.~   "
122974|NCT01957826|"~     The purpose of this study is to assess the safety, the feasibility and the efficacy of~     transendocardial injection of bone marrow-derived mesenchymal stem cells (MSCs) in patients~     with dilated idiopathic cardiomyopathy.~   "
122975|NCT01957813|"~     -Purpose: To develop and evaluate an intervention designed to improve consistent~     contraceptive use and dual method use in particular, among female sex workers (FSWs) in Rift~     Valley Province in Kenya.~      Design: A qualitative descriptive study will be conducted to develop the intervention. A~     quasi-experimental, non-randomized, two-group, pre-/post-intervention design will be used to~     evaluate the intervention.~      Study Population: FSWs living in Naivasha, Gilgil, and Nanyuki, Rift Valley Province.~      Study Duration: Phase I - 3 months Phase II - 12 months Objectives: Develop an intervention~     designed to increase contraceptive use among FSWs by incorporating formative data and~     behavioral theory and by involving the target audience and service providers in the~     development of the intervention.~      Examine the effectiveness of the intervention at increasing non-barrier modern contraceptive~     use and dual method use among FSWs.~      Assess the feasibility and acceptability of the intervention, on the parts of both the~     clients (FSW) and service providers.~      Estimate the unit cost to provide these services to one client. Study Site: Rift Valley~     Province, Kenya~   "
122976|NCT01957800|"~     A randomized controlled trial comparing the effects of the social-enabled internet weight~     loss and diet change intervention with the delayed treatment group for 3 months. We will~     study the effect of adding social interactions and supports to an Internet weight loss and~     diet change intervention. The website intervention will have action planning with social~     interactions and support features for sharing, reusing, recommending, and discussing~     strategies for improving habits. We hypothesize that the intervention group with access to~     the website will lose more weight than the delayed treatment group after three months.~   "
122977|NCT01957787|"~     The purpose of this study is to evaluate the safety and efficacy of cryoablation therapy used~     to treat tumors in patients with pulmonary metastatic disease. This study is to enroll~     patients who will undergo cryoablation of at least 1 metastatic pulmonary tumor that is less~     than or equal to 3.5cm. Patients will be followed 24 months post their cryoablation~     procedure.~   "
122978|NCT01957774|"~     The purpose of this study is to test the experimental drug THR-18 given together with the~     drug tissue plasminogen activator for the treatment of stroke. Tissue plasminogen activator~     is also called tPA.~      Strokes often result from blockade of blood supply caused by blood clots forming within the~     blood vessel feeding the brain. Such strokes are called Ischemic strokes. Treatment of~     these strokes is aimed at breaking up the blood clot(s) and renewing the blood flow before~     further parts of the brain die. Breaking up the blood clot is possible with the drug tPA when~     it is injected into a vein shortly after the stroke starts. However, along with breaking up~     the blood clot, tPA sometimes causes adverse effects, for example, it may cause bleeding.~     THR-18, the drug tested in this study, is meant to bind to tPA and reduce its adverse effects~     without stopping tPA's breaking up of the blocking blood clot.~      The primary purpose of this study is to evaluate the safety of THR-18 in acute ischemic~     stroke patients who are treated in parallel with tPA. Another purpose of this study is to~     investigate levels of THR-18 and tPA in the blood stream at different time points after they~     are injected, at the same time, into a vein. In addition, this study will measure tPA's~     effect on blood clot dissolution when tPA is given with and without THR-18. The study will~     also study the effect THR-18 may have on signals of brain damage that can be found in the~     blood after stroke: these signals of brain damage are small proteins called S100B and matrix~     metalloproteinase (MMP)-9. These proteins are released into the blood stream when the brain~     is injured.~      The safety evaluation of THR-18 in this study will be done in comparison to placebo. Placebo~     is a drug that looks exactly like THR-18 but has no activity. Three doses of THR-18 will be~     tested, one after the other, in three groups of patients. In each group, some patients will~     receive THR-18 and some will receive placebo. This clinical study will be conducted only at~     one hospital in the Ukraine. In total, 30 patients are planned to participate in this study.~     These patients will be in the hospital for at least 3 days after receiving the study~     treatment. Then, about 1 month later, they will be invited for a last follow-up visit.~   "
122979|NCT01957761|"~     Objectives:~        1. Describe the molecular epidemiology of Clostridium Difficile infection in children in~          the Chicago area.~        2. Determine the clinical spectrum and risk factors for Clostridium Difficile infection~          secondary to particular endemic strains in children.~        3. Define the risk factors for recurrent and community-associated Clostridium Difficile~          infection in children.~   "
122980|NCT01957748|"~     CCTG 594 is a controlled, unblinded, two-arm, randomized (1:1) clinical trial to evaluate the~     effectiveness of a clinic-based HIV ALERT specialist on improving endpoints of retention in~     care and maintenance of ART as compared to the current standard of care (SoC) in HIV primary~     care clinics.~   "
122981|NCT01957735|"~     This is a Phase 1a/b multicenter, open-label, non-randomized, dose-escalation study to~     examine the dose limiting toxicities (DLT) of BPM31510 administered as a 144-hour continuous~     intravenous (IV) infusion as monotherapy(treatment Arm 1) and in combination with~     chemotherapy (treatment Arm 2) in patients with solid tumors.~   "
122982|NCT01957722|"~     This study is to NOVOCART 3D relative to Microfracture for the treatment of knee cartilage~     defects. Efficacy will be evaluated by both pain and function. Safety will also be evaluated.~   "
122984|NCT01957696|"~     Several studies have shown acceptable results after Pancreas Transplantation (PTx) by~     substituting ATG with basiliximab, which is considered to convey a considerably lower number~     of adverse events. However, our experiences with ATG in PTx (introduced in 2004) are good,~     and our presumably gentle way of administrating the drug - directed by T-cell counts - is in~     fact unique. The potential advantages of reducing the overall corticosteroid (CS) load is~     obvious, as CS is a well-known pro-diabetic agent and causes severe long term adverse~     effects.~      On this background, the investigators have very recently reduced our CS dosing (in the~     routine protocol) to a level corresponding to our Kidney Tx protocol (valid since 2009).~      Thus, the investigators intend to prospectively investigate a single PTx cohort with the~     reduced CS immunosuppressive protocol by an observational study design, and compare with~     previous (historical) cohorts, who have received high dose CS.~      Study hypotheses: i) Low-dose CS is as effective as high-dose corticosteroids with regards to~     efficacy/rejections; ii) The rate of surgical and infectious complications will be similar or~     lower in the low-dose group; iii) PTx rejection surveillance by DD (duodenoduodeno-stomy) and~     EUSPB (Endoscopic Ultra-Sound guided Pancreas Biopsies) is superior to traditional rejection~     surveillance; iv) Patient and graft survival is similar in the two groups~   "
122985|NCT01957683|"~     The purpose of this study is to evaluate the safety and feasibility of the eCLIPs™ Family of~     Products for the treatment of unruptured intracranial bifurcation aneurysms in conjunction~     with embolization coils.~   "
122986|NCT01957670|"~     The study will assess the safety, tolerability and feasibility of Lacrima investigational~     medical device to treat dry eye patients~   "
122987|NCT01957657|"~     The objective of the trial is to investigate the effect of different degrees of renal~     impairment on the pharmacokinetics and safety of the combination of BI 207127 and faldaprevir~     after 3 days of dosing (BI 207127 bid, faldaprevir qd) and a single dose of BI 207127 and~     faldaprevir on day 4.~   "
122988|NCT01957644|"~     To investigate the maximum tolerated dose (MTD), safety, pharmacokinetics, and efficacy of~     volasertib in combination with azacitidine in patients with myelodysplastic syndromes (MDS)~     or chronic myelomonocytic leukemia (CMML) and not candidates for hematopoietic stem cell~     transplant~   "
122989|NCT01957631|"~     In cases of Plantar Fasciitis not responding to conservative management, minimally invasive~     techniques may be used. These include platelet rich plasma injections and corticosteroid~     injections. Corticosteroids have long been used for symptomatic relief. However there are~     growth factors present in PRP injections that contribute to the healing of the pathology, and~     not just symptom control.~      A single blind, prospective, randomized, comparative, control study will be performed. The~     study population consists of a total of 80 participants. They will be randomly assigned to~     receive either a corticosteroid injection, or a platelet rich plasma injection. Data will be~     collected through questionnaires and ultrasound findings. Patients will have a follow up at~     3, 6, 12, and 24 weeks after they receive their injection.~   "
122990|NCT01957618|"~     Hepatitis B virus (HBV) infection is a global health problem, especially in the endemic area~     like Taiwan, where there are more than 3 million chronic hepatitis B carriers. Patients with~     chronic HBV infection are at increased risk of developing cirrhosis, which may have~     disastrous complications, including hepatic decompensation, and hepatocellular carcinoma~     (HCC). The liver cirrhosis related complications accounts for the 8th leading cause of deaths~     in Taiwan; whereas, the HCC is the 2nd leading cause of deaths among all cancers. Therefore,~     it is prudent to develop strategies to prevent or halt the progression of liver cirrhosis.~      For HBV patients who have already had cirrhosis, the main treatment objective is to reduce~     their risk of complications. A large-scale multicenter clinical trial showed that viral~     suppression using lamivudine in patients with advanced fibrosis effectively decreases the~     risk of HCC and liver-related complications. This study highlights the importance to treat~     HBV-related cirrhosis patients; however, several issues remain to be addressed.~      The first issue is that this clinical trial only enrolled patients with positive HBeAg or~     HBV-DNA level >1.4 x105 IU/mL. However, the current recommended threshold for cirrhotic~     patients to start anti-viral treatment is 2000 IU/mL. Whether anti-HBV therapy benefits~     cirrhotic patients in this level is still unclear. Second, lamivudine was used in this~     clinical trial; however, the high resistant rate of lamivudine during treatment probably~     lowers its protective effect against HCC. Whether a more potent anti-HBV agent with extremely~     low resistance profile, entecavir, is more beneficial to HBV-related cirrhotic patients is~     also unclear.~      The Bureau of National Health Institute launched the reimbursement program for anti-HBV~     therapy since 2003 and extended this program to cirrhotic patients with HBV DNA level > 2000~     IU/mL for long-term use since Aug, 2010. Taking this advantage, we may explore the~     above-mentioned clinical questions more easily.~      To address these issues, we will first retrospectively collect a cohort of HBV-related~     cirrhosis patients. All the patients will be enrolled from the time before oral anti-HBV~     therapy is widely used. We will determine their baseline serum HBV-DNA levels using the~     stored sera and enrolled those with baseline HBV-DNA levels higher than 2000 IU/mL as our~     historical controls. Second, we will enroll a retrospective cohort of HBV-related cirrhotic~     patients from 2008 who had HBV-DNA levels higher than 2000 IU/mL and received indefinite~     therapy of entecavir. By comparing these two cohorts, we will be able to clarify whether~     indefinite viral suppression by entecavir is beneficial for the cirrhotic patients.~      With comprehensive analysis, we wish to document that re-setting the risk level of HBV DNA~     from 140,000 IU/mL to 2,000 IU/mL is more beneficial for HBV-related cirrhotic patients and~     long-term entecavir does lower the risk of HCC further. These lines of evidence will assist~     in delivering appropriate and more aggressive treatment for these high-risk patients.~   "
122991|NCT01957605|"~     Venous return is driven by the pressure gradient between mean systemic pressure and right~     atrial pressure. However, mean systemic pressure is more a physiological concept than an~     available clinical measurement. Indeed, the mean systemic pressure is the one that would be~     measured anywhere within the vascular system after cardiac arrest. Recent advances in~     hemodynamic monitoring have made MSP available to the clinician through beat-by-beat cardiac~     output measurements during respiratory pauses under mechanical ventilation. In this way, it~     is possible to calculate MSP, the pressure gradient and the venous return resistances. The~     investigators aim is to explain the hemodynamic variations and the decrease in cardiac output~     observed during prone position. The investigators hypothesis is that venous return~     resistances are increased during prone position probably following an increased~     intra-abdominal pressure.~   "
122992|NCT01957592|"~     This study is conducted in Asia. The aim of this non-interventional study is to evaluate the~     current status of diabetes management, control, and complications in diabetic subjects in Sri~     Lanka.~   "
122993|NCT01957579|"~     The primary objective of this study is to evaluate the safety and tolerability of MEDI-551 in~     Japanese patients with relapsed or refractory advanced B-cell malignancies.~   "
122994|NCT01957566|"~     The purpose of the study is to validate the diagnostic performance of the amplified~     pretracheal stethoscope (APS) to detect sedation-related adverse acute respiratory events in~     propofol sedated nonintubated children. To determine the sensitivity/specificity and~     positive/negative predictive value of the APS in detecting sedation-related adverse acute~     respiratory events in propofol sedated nonintubated children.~   "
122995|NCT01957553|"~     The aim of the current investigation is to investigate the performance of a new 2-piece~     ostomy product~   "
122996|NCT01957540|"~     Ticagrelor administration, whose molecule resembles to adenosine, led to reduction in overall~     mortality and thrombotic cardiovascular (CV) events when directly compared to clopidogrel in~     the PLATO trial, implicating possible pleiotropic actions for the drug. It has been shown~     that ticagrelor increases adenosine concentration, by interfering with its red blood cells'~     uptake and by inducing the release of ATP which is then converted to adenosine. Recent~     studies in healthy volunteers and patients with coronary artery disease (CAD) have shown that~     ticagrelor increases the coronary blood flow in response to intravenous adenosine~     administration. Ticagrelor administration, in comparison with other P2Y12 inhibitors, may~     influence the endothelial function, as assessed by the Peripheral Arterial Tonometry method~     (EndoPAT 2000 system (Itamar Medical, Caesarea, Israel), which is a method for evaluating~     endothelial dysfunction and has been found to positively correlate with flow mediated~     dilatation (FMD).~      This is prospective, randomized study with a crossover design, which will be conducted in~     patients with CAD under prasugrel maintenance dose (MD) 10mg once a day for at least a~     3-month period. At Day 0 (day of randomization) eligible patients will be assigned to either:~        -  Ticagrelor 90mg twice a day for the next 15 days or~        -  Prasugrel 10mg once a day for the next 15 days At Day 0 (before treatment onset)patients~          wiil be subjected to a baseline peripheral arterial tonometry measurement. Measurement~          will be repeated at Day 15 and then treatment crossover will be performed for the next~          15 days (without an intervening washout period). At Day 30 patients will be subjected~          again to peripheral arterial tonometry assessment. Peripheral blood sample will be taken~          from the patients in Day 0 for genotyping control.~   "
122997|NCT01957527|"~     Ticagrelor administration, whose molecule resembles to adenosine, led to reduction in overall~     mortality and thrombotic cardiovascular (CV) events when directly compared to clopidogrel in~     the PLATO trial, implicating possible pleiotropic actions for the drug. It has been shown~     that ticagrelor increases adenosine concentration, by interfering with its red blood cells'~     uptake and by inducing the release of ATP which is then converted to adenosine. Recent~     studies in healthy volunteers and patients with coronary artery disease (CAD) have shown that~     ticagrelor increases the coronary blood flow in response to intravenous adenosine~     administration. Ticagrelor administration, in comparison with other P2Y12 inhibitors, may~     influence the endothelial function, as assessed by the Peripheral Arterial Tonometry method~     (EndoPAT 2000 system (Itamar Medical, Caesarea, Israel), which is a method for evaluating~     endothelial dysfunction and has been found to positively correlate with flow mediated~     dilatation (FMD).~      This is a prospective, observational study, which will be conducted in patients with coronary~     artery disease subjected to percutaneous coronary intervention (PCI) under ticagrelor~     maintenance dose (MD) 90mg x 2, who are about to stop treatment, due to completion of 1 year~     antiplatelet therapy. Eligible patients will be subjected to peripheral arterial tonometry at~     Day 0 (immediately after receiving the last pill of ticagrelor) and at day 2 and day 5 post~     study drug discontinuation. Peripheral blood sample will be taken from the patients at Day 0~     for genotype analysis.~   "
122998|NCT01957514|"~     This pilot research trial studies collecting, analyzing, and storing samples from patients~     with triple negative breast cancer (breast cancer cells that do not have estrogen receptors,~     progesterone receptors, or large amounts of human epidermal growth factor receptor 2 protein)~     that has spread to other places in the body receiving anti-cancer therapy. Studying samples~     of tissue, blood, buccal swab, saliva, and urine in the laboratory from patients receiving~     anti-cancer therapy may help doctors learn more about changes that occur in deoxyribonucleic~     acid (DNA) and identify biomarkers related to cancer.~   "
122999|NCT01957501|"~     Depression and bipolar disorder are major public health concerns for adolescents today.~     Teenage depression and bipolar disorder are associated with social isolation, family stress,~     school failure, substance abuse and suicide. Screening for depression and bipolar disorder so~     that treatment can be started early in the course of illness is an urgent public health~     priority. Many teens with bipolar disorder are incorrectly diagnosed as having unipolar~     depression. It is critical that adolescents receive proper screening and assessment that~     leads to an accurate diagnosis and treatment. An efficient, cost-effective, blood-based~     screening program could be performed on an annual or semi-annual basis to potentially detect~     depression and then differentiate between unipolar and bipolar depression. If this type of~     screening were able to detect a significant percentage of teens with depression or bipolar~     disorder, the positive impact on U.S. public health would be substantial. The purpose of this~     study is to conduct a pilot study to assess the probability of detecting adolescent unipolar~     and bipolar depression through blood samples.~   "
123000|NCT01957488|"~     The aim of the current investigation is to investigate the performance of two new 1-piece~     ostomy products~   "
123001|NCT01957475|"~     The aim of the current investigation is to develop new soft and more flexible 2-piece convex~     ostomy appliances~   "
123002|NCT01957462|"~     The aim of the current investigation is to develop new soft and more flexible 1-piece convex~     ostomy products.~   "
123003|NCT01957449|"~     To determine the safety and efficacy of administration of propranolol for reducing heart rate~     and blood pressure in burn injury.~   "
123004|NCT01957436|"~     This is a multi-center phase III study to compare the clinical benefit of androgen~     deprivation therapy (+ docetaxel) with or without local radiotherapy with or without~     abiraterone acetate and prednisone in patient with metastatic hormone-naïve prostate cancer.~   "
123005|NCT01957423|"~     The objective of this study was to evaluate the effect of Whey Protein (WP) and Soy Protein~     (SP) nutritional supplements on nutritional status and disease activity in Crohn's disease~     patients.~   "
123006|NCT01957410|"~     To evaluate if somatosensory evoked potentials (SEPs) and motor evoked potentials (MEPs)~     obtained with electroencephalography (EEG) and electromyography (EMG) can be used to detect~     changes in cortical plasticity in responders to a single IV infusion of ketamine as compared~     to non-responders.~   "
123007|NCT01957397|"~     To investigate the performance and safety of the three 2-piece convex ostomy appliances~   "
123008|NCT01957384|"~     To assess the functionality and safety of the test products and also assess the products'~     ability to collect stool without interfering with the stoma. The degree of leakage using the~     product will also be measured~   "
123009|NCT01957371|"~     The primary objective of the current study is to establish the safety and acceptability of~     Mindful Yoga Therapy as an adjunctive treatment for Posttraumatic Stress Disorder (PTSD) and~     chronic pain among OEF/OIF/OND Veterans. The current study also seeks to establish~     preliminary efficacy of MYT for reduction of PTSD and chronic pain symptoms and explore~     anxiety sensitivity as a mechanism of therapeutic action.~   "
123010|NCT01957358|"~     The purpose of this study is to examine the usefulness of the Grief Recovery Method in~     assisting persons with spinal cord injuries to achieve as complete a recovery as possible,~     thereby allowing for fuller participation in life.~   "
123012|NCT01957332|"~     Current patient work-up, including conventional imaging and pathological assessment of just~     one single biopsy, might be insufficient to identify metastatic breast cancer patients, who~     possibly benefit from first-line anti-hormonal or anti-HER2 therapy. As receptor conversion~     of the tumor is found quite frequently and molecular heterogeneity can occur within one~     patient, up-to-date whole body information is necessary to determine estrogen receptor (ER)~     and/or human epidermal growth factor receptor 2 (HER2) receptor status and subsequently guide~     therapy decision. With molecular imaging via PET this information can be obtained in a~     non-invasive, patient friendly way. Furthermore, to improve and individualize treatment and~     be able to identify (new) drug targets and biomarkers, sampling of venous blood, circulating~     tumor cells (CTC), as well as circulating tumor DNA, microRNA (miRNA) and molecular~     characterization of one metastasis at the beginning and, if feasible, of an additional biopsy~     during therapy, is necessary.~   "
123013|NCT01957319|"~     Background: Hepatitis C virus infection and interferon treatment have shown to be risk~     factors for depression, distressing, psychosocial burden and poor health-related quality of~     life.~      Aim: To determine the effect of a Sylibin-vitamin E-phoshpolipids complex on work ability and~     whether health related factors (anxiety and depression) were associated with work ability in~     subjects with chronic hepatitis C treated with Peg-IFN-α and RBV.~      Patients and Methods: In this prospective, randomized, placebo controlled, double blind~     clinical trial, 31 subjects (Group A) with chronic hepatitis, received~     Pegylated-Interferon-α2b (1.5 mg/kg per week) plus Ribavirin and placebo, while 31 subjects~     (Group B) received the same dosage of Pegylated-Interferon-α2b plus Ribavirin plus~     association of Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg in one pill for 12~     months. All subjects underwent laboratory exams and questionnaires to evaluate depression~     (Beck Depression Inventory - BDI), anxiety (State-trait anxiety inventory - STAI) and work~     ability (Work ability Index - WAI).~   "
123014|NCT01957306|"~     The primary goal of this study is to evaluate the safety and efficacy of 12 weeks of~     treatment of 4 grams/day of Dr. Tagliaferri's Menopause Formula (administered as 2 grams PO~     BID) in reducing the frequency of menopausal vasomotor symptoms among healthy, postmenopausal~     women, aged 40-65, with moderate to severe hot flushes.~   "
123015|NCT01957293|"~     Aim is to investigate the effect of beta2 adrenergic stimulant salbutamol on emotional and~     cognitive functions in healthy humans.~   "
123016|NCT01957280|"~     The purpose of this study is to assess the PK, safety, and tolerability of patritumab~     produced by a new manufacturing process (denoted as Process 2 patritumab). The data from~     this study will allow Process 2 patritumab to be compared to Process 1 patritumab to allow~     for any dose adjustments, if needed, and to bridge data from studies previously conducted~     with Process 1 patritumab to studies to be conducted with Process 2 patritumab. The~     hypothesis for this study is that the pharmacokinetics of Process 2 patritumab will be~     comparable to those of Process 1 patritumab.~   "
123017|NCT01957267|"~     The specific aims of the clinical studies are to:~        -  Develop quantitative wide-field OCT angiography.~        -  Simulate visual field results by combining structural and angiography OCT data.~        -  Establish or validate age-adjusted normal reference ranges for above OCT-derived~          parameters.~        -  Establish criteria for glaucoma diagnosis based on above imaging-derived parameters.~        -  Evaluate the sensitivity and specificity of above OCT-derived parameters~        -  Measure the rate of normal age-related change in above OCT-derived parameters.~        -  Assess the reproducibility of above OCT-derived parameters.~        -  Assess abilities of above OCT-derived parameters on predicting glaucoma conversion and~          progression.~   "
123018|NCT01957254|"~     Endotoxin is the major mediator of gram-negative bacteria which cause the systemic~     inflammation and result in microcirculatory dysfunction, and it leads to multiple organ~     dysfunction and death in patients with severe sepsis and septic shock. The goal of this study~     is to measure the endotoxin activity of patients with severe sepsis and septic shock at~     certain time points, and furthermore, to compare the difference of endotoxin activity among~     different pathogens, infection source, and antibiotics. The study will enroll severe sepsis~     and septic shock patients. The endotoxin activity will be measured at certain time points~     according to the protocol.~   "
123019|NCT01957241|"~     The primary goal of this study is to quantify the biomarkers of pre-radiation therapy(RT),~     during-RT, and post-RT serum samples from hepatocellular carcinoma (HCC) and esophageal~     cancer patients undergoing definitive or neoadjuvant RT, and to correlate them with tumor~     response, patterns of failure, survival outcome, and RT-related lung or liver toxicity. The~     secondary goal of this study is to set up the PLA platform in our institute for future~     biomarker test.~   "
123020|NCT01957228|"~     On joint orthopaedic hardware infections are one of the most frequently encountered~     complications in orthopaedic surgery. However 6% of the cultures remain sterile, etiological~     diagnosis cannot be established despite obvious signs of infection. As part of this research~     project, we have developed a new strategy diagnosis including directly the use of PCR to~     reduce the number of negative results. This should have a major therapeutic impact in terms~     of timeliness and specificity of antibiotic.~      Primary:~      Evaluate the effectiveness of the new diagnostic strategy on etiological identification of~     prosthesis infections.~      Hypothesis:~      Minimum 6 percent increase in the number of patients with an etiological diagnosis of~     infection on prosthesis.~   "
123021|NCT01957215|"~     This study will investigate the efficacy of the Indomethacin patch in pain relief of ankle~     sprain in adult patients, compared to a placebo patch~   "
123022|NCT01957202|"~     This study will be a randomised, double blind, placebo controlled, 3-way, incomplete block~     crossover study to evaluate the effect of single and repeat doses of levocabastine, FF,~     placebo and a FDC of FF/levocabastine administration in AR subjects. The total expected study~     duration for each individual participating in the study will be a maximum of up to 20 weeks~     (including the screening and follow-up). This will be a three period study and subjects will~     be assigned to a sequence of three treatments. There will be a wash-out period of 14-28 days~     between two treatment periods. The rational for this study is to demonstrate proof of concept~     with the FDC of FF and levocabastine compared with each of the components administered alone.~   "
123023|NCT01957189|"~     This will be an open-label, three-period, fixed-sequence study to evaluate the drug-drug~     interaction, pharmacokinetics and safety of dutasteride and tamsulosin when administered~     alone and in-combination in Chinese healthy male volunteers.~   "
123025|NCT01957163|"~     After screening, subjects will enter a 4 week open-label run-in period with fluticasone~     furoate (FF)/vilanterol (VI) 100/25 mcg administered once daily via dry powder inhaler (DPI).~     Subjects will then be randomized to receive any one of the 3 treatments (umeclidinium bromide~     [UMEC] [62.5 mcg] administered once daily via a DPI; OR UMEC [125 mcg] administered once~     daily via a DPI; OR matching placebo administered once daily via a DPI), while continuing~     treatment with open label FF/VI 100/25 mcg during a 12-week treatment period. There will be a~     total of eight scheduled clinic visits at Pre-Screening (Visit0), Screening (Visit 1),~     blinded treatment Day 1(Visit2), 2(Visit3), 28 (Visit4), 56 (Visit5), 84 (Visit6) and 85~     (Visit7). A follow-up phone contact will be conducted approximately 7 days after the last~     clinic visit. The total duration of subject participation in the study from Screening to~     Follow-up will be approximately 17 weeks.~   "
123026|NCT01957150|"~     This is a multi-center, randomized, double-blind, parallel-group study. The FF/VI inhalation~     powder once daily and VI inhalation powder once daily will be evaluated in subjects with COPD~     over 156 weeks. The primary objective of this study is to evaluate the effect of the inhaled~     corticosteroid FF on bone mineral density assessed at the total hip by comparing FF/VI~     treatment with VI treatment in subjects with moderate COPD.~   "
123027|NCT01957137|"~     The study will assess the effects of different InterStim cycling settings on urinary urge~     incontinence.~   "
123028|NCT01957124|"~     Hypertensive leg ulcers are very painful and difficult to treat ulcers. Their treatment is~     not well established.~      We want to study the efficacy of PRF applications on the pains related to those ulcers.~      PRF (Platelet-Rich Fibrin) is an autologous fibrin clot, obtained extemporaneously from~     patient's blood, without any additive nor complex manipulation. It contains blood platelets~     and white blood cells, trapped in fibrin during clot formation.~      PRF (Platelet-Rich Fibrin) is form immediately after blood punction in a dry tube, that does~     not contain any anticoagulant. Coagulation naturally occurs within few minutes, and tubes are~     placed in a centrifuge: red blood cells are separated from the fibrin clot thanks to~     difference of density, and blood platelets and white blood cells are trapped in the fibrin~     clot.~      The fibrin clot is then rapidly applicated on the ulcer surface for four days. Our hypothesis~     is that platelet growth factors and cytokines, liberated during platelet activation, could~     help to treat hypertensive leg ulcers, that are caused by a vascular spasm.~   "
123029|NCT01957111|"~     Individuals with insomnia have been shown to have higher overall metabolic rates compared to~     good sleepers, but it is not known which metabolic processes are involved. The goal of this~     study is to compare a wide array of metabolic processes in 15 people with insomnia and 15~     good sleepers. We hypothesize that there will be distinct metabolic processes that are~     functioning differently in those with insomnia.~   "
123030|NCT01957098|"~     The purpose of this study is to investigate the effect of L-arabinose and D-xylose in a~     sugar-rich drink on intestinal sucrase activity in healthy volunteers by measuring~     postprandial blood glucose and insulin, and selected intestinal hormonal responses to~     increasing doses of L-arabinose and D-xylose.~   "
123031|NCT01957085|"~     The Centers for Disease Control and Prevention estimates that there are approximately 3.2~     million people in the United States infected with hepatitis C and a significant percentage of~     these patients are unaware of their diagnosis. This study will attempt to determine the point~     prevalence of undiagnosed hepatitis C infection in an urban hospital population. All patients~     admitted to the hospital on two separate days will have hepatitis C testing done on leftover~     serum and plasma that was collected as part of routine inpatient lab work. Our primary goal~     is to determine the number of undiagnosed hepatitis C infected patients in our hospitalized~     population. We will also compare these rates to specific demographic characteristics, such as~     age, race, gender, zip code and type of insurance to see if any associations exist between~     these demographics and undiagnosed hepatitis C infection.~   "
123032|NCT01957072|"~     Cystic Fibrosis (CF) is a lifelong condition which causes the lungs and digestive system to~     become clogged with thick, sticky mucus. This leads to recurrent lung infections and reduced~     nutrients absorption from food. The average age at death is 26 years, usually from~     respiratory failure. Nonetheless, the nutritional status of people with CF (PWCF) is~     important help them live healthier and longer.~      It is recommended that adult with CF achieve a BMI of 23 for males and 22 for females.~     However, fewer than 50% adult with CF achieved that target BMI despite effective nutritional~     support to help support weight gain. There is a clear need for a behavioural intervention~     that can help PWCF use the available nutritional support.~      This is a feasibility study to try out a multi-component behavioural intervention. The~     intervention is designed to help PWCF use their nutritional support to gain weight. It will~     focus on testing the methods and procedures to be used on a larger scale, improving the~     behavioural intervention and estimating the how many people are needed for the larger trial.~      All eligible 75 PWCF in Sheffield will be invited to participate. The investigators~     anticipate recruiting 30 participants. Participants will be divided into two groups. The~     first group receive the behavioural intervention immediately. The second group receive the~     intervention after 3 months. All participants will be followed up for 6 months. Data will be~     collected every 6 weeks during clinic reviews.~      These two groups will be compared against each other to estimate the potential impact of the~     behavioural intervention. The investigators will also interview some of the participants at~     the end of the study period to improve the intervention and the study processes based on~     participant feedback.~      The investigators hypothesised that this study will recruit around 30 participants, around~     80% of the participants will complete the study, a single full-time investigator can deliver~     the intervention to 15 participants over 3 months and data collection will be thorough (with~     less than 5% missing data). The investigators also hypothesised that this feasibility study~     will help improve the intervention and help the design of a larger trial.~   "
123033|NCT01957059|"~     The purpose of the study is to see whether BMN053 is safe and effective to use as medication~     for Duchenne muscular dystrophy (DMD) patients with a mutation around location 53 in the DNA~     for the dystrophin protein.~   "
123034|NCT01957046|"~     The main purpose of this study is to assess how effective and tolerable the country specific~     clinical practice guidelines of SLTs are for UK, France and Sweden are.~      The main rationale behind this study is that well controlled comparisons of the various~     laxatives for the treatment of OIC are lacking. There is lack of evidence suggesting which~     laxative or combination of laxatives is optimal for managing OIC.~   "
123088|NCT01956344|"~     The purpose of this research is to measure changes in brain activity with functional magnetic~     resonance imaging (fMRI) before and after cognitive-behavioral therapy for compulsive~     hoarding. Cognitive-behavioral therapy aims to help people change the thoughts and behaviors~     that maintain symptoms of hoarding. The investigators intend to enroll approximately 80~     people with hoarding disorder and 40 people with no psychiatric disorder, between the ages of~     20 and 60, for this study. The investigators believe that after treatment there will be~     changes in the brain activity of individuals with compulsive hoarding.~   "
123089|NCT01956331|"~     schema : Prospective prognostic study The main objective is to study the value of the~     Comprehensive Geriatric Assessment in predicting the risk of post operative complications~     after lung resection for cancer.~   "
123035|NCT01957033|"~     The purpose of this pilot project is to determine the feasibility of a study design to~     investigate how many sessions of manual therapy and exercise produce the best results for~     people with whiplash injuries. Also, this study will help us determine the best way to~     measure the effect of treatment. Finally, the investigators will study how closely the~     physiotherapists follow the treatment instruction provided in the study protocol and~     training. In order to achieve these objectives, 12 people will receive manual therapy and~     exercise at one of twelve different doses. the investigators will have each of these people~     fill out questionnaires, measure sensation changes, and measure changes in the way people~     move their necks while walking. This study will help us determine if the study protocol can~     be carried out as planned. This includes: the training of all people involved in carrying out~     the assessments and treatments, the willingness and ability of participants to take part in~     all of the treatment and measures involved. This will provide us with important information~     to help us plan a larger study with 226 people with whiplash injuries.~   "
123036|NCT01957020|"~     Stereotactic directional vacuum-assisted breast biopsy (ST DVAB) is a standard biopsy~     procedure for suspicious findings on mammograms in Western countries for more than 10 years~     [1-3], it has replaced the needle localization (NLOC) excisional biopsy for the lesions alike~     and was reported to feature a high sensitivity, very low delayed false-negative rate (less~     than 2%)[4,5]. Moreover, it causes less scarring, less psychologic stress to patients and~     less morbidity compared with needle localization excisional biopsy [6,7]. However, its~     sensitivity, accuracy has seldom been reported in Asian countries [8] , since most Asian~     women have different breast parenchyma pattern, different breast cancer prevalence.~     Therefore, we retrospectively reviewed outcomes of the two groups of patients receiving~     either ST DVAB or NLOC excisional biopsy, trying to investigate if ST DVAB can be an~     effective alternative to NLOC excisional biopsy in our country.~   "
123037|NCT01957007|"~     This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and~     PK of vantictumab when combined with docetaxel.~   "
123038|NCT01956994|"~     The hardening of the arteries observed with aging raises blood pressure and contributes to~     poor brain blood flow and loss of cognitive function (i.e. attention, memory, solving~     problems, making decisions). Cognition is the most important determinant of overall health~     status, quality of life, functional ability and independence in older adulthood.~     Nutraceutical strategies have received considerable attention as they may improve~     cardiovascular health with far fewer side effects compared to drugs. In this regard, dairy~     products are particularly attractive. Higher dairy consumption is associated with lower blood~     pressure and improved memory in adults. Milk proteins have natural blood pressure lowering~     effects. Studies conducted in animals have demonstrated that whey protein (a component of~     milk protein) may also increase artery elasticity. This is important given the strong~     association between artery elasticity, brain blood flow, and risk for cognitive decline.~      The investigators propose to conduct a randomized double-blind placebo controlled study~     comparing the effects of whey protein supplementation or carbohydrate placebo on measures of~     artery elasticity, brain blood flow, and cognitive function in older adults. Whey protein may~     be a novel dietary therapy to improve both artery health and brain health in older adults.~   "
123039|NCT01956981|"~     It is very important to decrease the bleeding during functional endoscopic sinus surgery~     (FESS) in order to increase the visibility of the surgical site. Our primary goal was to~     investigate the effects of magnesium sulfate and dexmedetomidine used for controlled~     hypotension on visibility of surgical site.~   "
123040|NCT01956968|"~     Shoulder pain may result from abnormal arm or shoulder blade (scapular) movement. These~     abnormal movements may result from a variety of flexibilty, motion or strength impairments.~     Therefore identifying any abnormal arm or scapular movement, as well as any impairments that~     are associated with them can help clinicians plan a proper management strategy for patients~     presenting with shoulder disorders. Our hypothesis is that specific impairments will be~     associated with abnormal arm movement, while other impairments will be associated with~     abnormal scapular movement among patients with shoulder pain.~   "
123041|NCT01956955|"~     Purpose and rationale: Acute pulmonary embolism (PE) is a common and often fatal disease,~     with an approximately 30% mortality rate without treatment. Treatment is important to reduce~     mortality and recurrence in acute PE. Therapeutic options for PE include subcutaneous low~     molecular weight heparin (SC LMWH), intravenous unfractionated heparin (IV UFH), subcutaneous~     unfractionated heparin and subcutaneous fondaparinux with or without thrombolysis. In the~     treatment of acute PE, SC LMWH has been shown, at least, as effective and safe as IV UFH [4].~     Compared to IV UFH, SC LMWH associated with lower mortality, fewer recurrent thrombotic~     events and less major bleeding. Current guidelines recommend use of SC LMWH for most~     hemodynamically stable patients with PE and they say that SC LMWH have not been tested in the~     setting of acute massive PE.~      The purpose of this study is to demonstrate that SC LMWH is as safe as IV UFH in the~     treatment of acute PE in combination with thrombolytic treatment.~   "
123042|NCT01956942|"~     The purpose of this study is to evaluate the effectiveness of a new laser (called Micropulse~     Laser Trabeculoplasty or MLT) in the treatment of glaucoma compared to the conventional laser~     presently used which is called selective laser trabeculoplasty or SLT. Both lasers (SLT and~     MLT) are used as standard of care in the treatment of open angle glaucoma.~   "
123043|NCT01956929|"~     This study is being done to understand metformin's mechanisms of action regarding glucose~     production, protein metabolism, and mitochondrial function.~   "
123090|NCT01956318|"~     At 3 months, crenobalneotherapy session is superior to waiting list for patients with chronic~     venous insufficiency.~   "
123091|NCT01956305|"~     DS-7309 is being developed for the treatment of type 2 diabetes mellitus (T2DM). This will be~     a randomized, placebo-controlled, blinded, sequential, multiple ascending dose study to~     assess the safety, tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of multiple~     doses of DS-7309 in subjects with T2DM.~   "
123092|NCT01956292|"~     Evaluation of blood pressure variability in the acute phase of intraparenchimal cerebral~     haemorrhage and its consequences to clinical outcome~   "
123243|NCT01954329|"~     MIND-TIA is primarily an observational diagnostic study that aims to evaluate the role of~     novel biomarkers in the diagnosis of Transient Ischemic Attack (TIA)in primary care.~      Rapid and adequate diagnosis of TIA is of great importance to enable a rapid start of~     treatment, and thereby decrease the risk of subsequent ischemic stroke.~   "
123044|NCT01956916|"~     Cystic fibrosis (CF) is a complex systemic disease that mainly involves the respiratory and~     gastrointestinal (GI) tracts. The polymicrobial community composition of respiratory and GI~     tracts is influenced by both genetic and environmental factors. Children with CF may harbor~     an abnormal intestinal microflora, because of altered cystic fibrosis transmembrane~     conductance regulator (CFTR) function and heavy drug load (antibiotics, pancreatic enzymes~     and acid suppressors). The investigators have previously demonstrated that intestinal~     inflammation is highly frequent in CF children, being a major feature of intestinal~     involvement. In addition, specific probiotics significantly improved airway and GI~     inflammation in a preliminary trial. The investigators aim to characterize intestinal and~     respiratory microflora in CF patients and to investigate the effects of daily Lactobacillus~     GG (LGG) supplementation on both GI and airway microflora and the eventual relationship~     between probiotic assumption and clinical and inflammation markers. The investigators aim is~     to eventually improve the quality of life of CF patients, who often suffer from intestinal~     and respiratory progressive disease, through a non invasive intervention consisting in the~     supplementation of probiotic bacteria.~   "
123045|NCT01956903|"~     The purpose of this study is to determine the safety and efficacy of sequential infusion of~     allogenic mesenchymal stem cells (MSC) expanded in vitro in treating patients with acute~     graft-versus-host disease refractory to first-line therapy.~   "
123046|NCT01956890|"~     This prospective study is aimed to evaluate the diagnostic effectiveness of 18F-FLT PET in~     differentiating benign nature from malignancy for lesions with suspicious or ambiguous~     findings on mammography or ultrasound; to determine whether 18F-FLT PET or MRI can increase~     the specificity in breast lesion diagnosis and thus reduce the unnecessary biopsy, and which~     (18F-FLT PET or MRI) reveals the higher diagnostic performance.~   "
123047|NCT01956877|"~     To assess normal values of EGJ distensibility in healthy volunteers.~   "
123048|NCT01956864|"~     The purpose of this study is to evaluate the safety and tolerability of a high dose of~     vitamin D (VD) in patients with cirrhosis. The investigator hypothesizes that high dose VD~     will be safe and well-tolerated in adults with cirrhosis, and will inhibit the inflammatory~     and proliferative events that cause progression of cirrhosis to hepatocellular carcinoma.~   "
123049|NCT01956851|"~     Since the discovery of kisspeptin as a gate-keeper of hypothalamo-pituitary-gonadal axis,~     there has been tremendous interest in the molecule. The relevance of kisspeptin as regulatory~     molecule for the reproductive system has been well documented in significant number of~     trials. (1, 2) This leads to the possibility that kisspeptin could be involved in an equally~     pivotal role in the other sites, where it is located, namely pancreas.~      While various animal experiments have suggested that kisspeptins regulate insulin secretion,~     we do not know if this is also true in humans. The investigators hypothesize that kisspeptin~     levels are significantly low in individuals who have low endogenous insulin secretion.~      While various animal experiments have suggested that kisspeptins regulate insulin secretion,~     the investigators do not know if this is also true in humans. Investigators hypothesize that~     kisspeptin levels are significantly low in individuals who have low endogenous insulin~     secretion.~      Thus investigators are conducting this study to understand the link between endogenous~     insulin secretion and kisspeptin levels among individuals with various levels of insulin~     secretory defect as seen in diabetics. Investigators believe that this will help understand~     the physiologic mechanisms, and kisspeptin based insulin regulation among individuals with~     diabetes mellitus.~   "
123050|NCT01956838|"~     Rationale: The appearance of tastants in the small intestine can result in the activation of~     a negative feedback mechanism from different parts of the intestine to the stomach, the small~     intestine and to the central nervous system. These processes inhibit food processing,~     appetite sensations and food intake, and furthermore they increase feelings of satiety and~     satiation. We will investigate the effects of intraduodenal infusion of quinine 75mg~     (bitter), rebaudioside A 540mg (sweet), monosodium glutamate 2g (umami), a combination of~     these tastants (quinine, rebaudioside A, monosodium glutamate) and placebo (5 test days in~     total) on ad libitum food intake, satiation and in vivo release of the gut satiety peptides~     CCK and GLP-1.~      Study design: To assess the effect of intraduodenal infusion of single ingredients and a~     combination of tastants (bitter, umami and sweet) on ad libitum food intake.~      Secondary Objective(s):~        1. To investigate the effect of intraduodenal delivery of a combination of tastants on~          satiation.~        2. To assess the effect of intraduodenal delivery of a combination of tastants on~          gastrointestinal hormone release.~        3. To assess the effects of the tastants quinine, rebaudioside A and monosodium glutamate~          on the parameters as mentioned under the primary objective, and under secondary~          objectives 1 and 2.~        4. To compare the effects, as mentioned under the primary objective, and under secondary~          objectives 1 and 2, of the combination of tastants to those of the three single tastants~          quinine, rebaudioside A and monosodium glutamate.~   "
123051|NCT01956825|"~     The purpose of this study is to determine whether the dual therapy of the amino acid~     L-CARNITINE and magnesium have an effect on reducing the liver fat content in patients with~     non alcoholic fatty liver disease (NAFLD).~   "
123052|NCT01956812|"~     The is a double-blind, randomized phase 3 study of 90Y-clivatuzumab tetraxetan with low-dose~     gemcitabine, versus placebo and low-dose gemcitabine in metastatic pancreatic cancer patients~     who have progressed on at least 2 prior therapies for metastatic cancer (1 of which was a~     gemcitabine-containing regimen).~   "
123053|NCT01956799|"~     The study aims to evaluate the molecular mechanism underlying the erythroid response observed~     in some patients with myelodysplasia, myelofibrosis and aplastic anemia treated with~     Deferasirox or Deferoxamina.~   "
123054|NCT01956786|"~     To evaluate the efficacy of Amlodipine-Folic Acid Tablets on reduction of blood pressure and~     plasma total homocysteine.~   "
123093|NCT01956279|"~     This study will investigate the use of adjunctive pregnenolone for the following:~        1. fatigue that has limited usual activity,~        2. musculoskeletal pain involving 2 or more regions of the body and,~        3. cognitive symptoms (memory, concentration, or attentional difficulties by self-report)~          in Veterans deployed to the Gulf War theatre of operations between 1990 and 1991.~   "
123254|NCT01954186|"~     To compare the efficacy of the route and timing of oxytocin administration for Active~     management of third stage of labour (AMTSL).~   "
123055|NCT01956773|"~     The outcome of this research will be a demonstration that family health history (FHH) risk~     data can be used efficiently to deliver more effective healthcare in geographically and~     ethnically diverse clinical care environments. Although FHH is a standard component of the~     medical interview its widespread adoption is hindered by three major barriers: (1) a dearth~     of standard collection methods; (2) the absence of health care provider access to complete~     FHH information; and (3) the need for clinical guidance for the interpretation and use of~     FHH. In addition, the time constraints of the busy provider and poor integration of FHH with~     paper medical records or electronic medical records (EMR) impede its widespread use. The~     investigators hypothesize that patient-driven and electronic collection of FHH for risk~     stratification will promote more informed decision-making by patients and providers, and~     improves adherence to risk-stratified preventive care guidelines. The study team will use an~     implementation sciences approach to integrate an innovative FHH system that collects FHH from~     patients. Intermountain Healthcare will provide the information technology expertise with EMR~     design to develop an innovative solution to a storage model standard for FHH data as well as~     a centralized standards-compliant open clinical decision support (OpenCDS) rule development~     architecture to analyze FHH and to generate evidence-based, individualized, disease risk,~     preventive care recommendations for both patients and providers.~   "
123056|NCT01956760|"~     The aim of this clinical study is to observe the therapeutic effect of acupuncture and~     intradermal acupuncture in the treatment of insomnia~      Participants were randomized into the acupuncture group and control group. Both groups were~     treated 3 times in a week and assessed before and after the treatment.~      Hypothesis :~        1. Acupuncture group will produce superior effect in the treatment of insomnia compared~          with control group.~        2. Acupuncture group will produce superior improvement in anxiety, depression, quality of~          life, sleep log, recognition, attention, and memory.~   "
123057|NCT01956747|"~     The purpose of this study is to assess whether the presence of a Myelodysplastic Syndrome~     (MDS) , Idiopathic Cytopenia of Undetermined Significance (ICUS) or Idiopathic Dysplasia of~     Undetermined Significance (IDUS), correlates with treatment intensity and clinical outcome in~     older patients with advanced malignancies receiving palliative chemotherapy. We will study~     the relation between sarcopenia, comprehensive geriatric assessment en pharmacokinetics with~     treatment related toxicity as well. We hypothesize that a standardized flow cytometry test to~     determine bone marrow capacity, a Comprehensive Geriatric Assessment and/or measurement of~     human body composition with computerized tomography will provide an accurate tool to optimize~     treatment strategies in elderly patients with advanced malignancies.~   "
123058|NCT01956734|"~     Phase I trial, unicentric, uncontrolled. Intratumoral injection or intramural (into the~     resected tumor cavity) of DNX2401 into brain tissue will be followed by up to two 28 - day~     cycles of oral temozolomide (TMZ) in schedule of 7 days on/7 days off to evaluate safety of~     the combination. Completion of two full cycles of TMZ will be dependent upon tolerance and~     toxicity.~      The rationale in using the virus with chemotherapy begins with the lessons learned in many~     clinical trials in glioblastoma (GBM) about both the great difficulty of treating this~     disease with monotherapy and the limitations of the therapeutic virus. The best clinical~     results in recent years have been achieved with combinations of multiple therapeutics~     efforts, including, maximum resection and chemotherapy, immunotherapy and targeted therapies.~      There are very strong preclinical data about the synergy of DNX-2401 and TMZ proposed in our~     trial design. The dose-dense schemes of TMZ like the one we will use, have been developed~     with the aim to saturate o6-methylguanine-DNA-methyltransferase (MGMT). The published results~     to date have shown reasonable toxicity albeit with modest efficacy' these schemes are now in~     phase III trials. In addition, autophagy triggered by TMZ could help viral replication in the~     tumor cells 11.~      The last argument in favor of this virus + TMZ combination is the proved efficacy in killing~     GBM tumor stem cells. In vitro and animals models have shown this combination is much more~     effective that any of the treatments alone against GBM stem cells and the tumors derived from~     them.~   "
123059|NCT01956721|"~     The aim of this project is to investigate the impact of heart failure (HF) on calcium~     homeostasis, mitochondrial function and oxydative stress in human skeletal muscle. The role~     playing by circulating factors such as cytokines and catecholamines will also be evaluated.~     24 HF patients wiil be enrolled in the study: 12 male volunteers with a fraction of ejection~     ≥ 50% and 12 male volunteers with a fraction of ejection ≤ 35%. They will be compared to 12~     sedentary healthy male volunteers, matched on age and physical activity.~   "
123060|NCT01956708|"~     Remote ischemic preconditioning (RIPC) with transient upper limb ischemia/reperfusion~     provides peri-operative myocardial protection, is safe and improves prognosis in patients~     undergoing elective CABG surgery.~      The signal transfer from limb to heart is unknown. Thus, the aim of this study is to identify~     the pathways which transfer the cardioprotective signal from the ischemic/reperfused~     extremity to the heart in humans undergoing surgical coronary revascularization.~   "
123061|NCT01956695|"~     Because Primary Central Nervous System Lymphoma (PCNSL) are mainly diffuse large B-cell~     lymphoma of the activated B cells (ABC) type, the investigators hypothesize that the synergy~     of lenalidomide with rituximab shown in systemic non-Hodgkin's lymphoma (NHL) could be~     observed in PCNSL.~      This study will assess the efficiency of the the combination of lenalidomide and rituximab in~     relapsed/refractory PCNSL, and the efficiency of a maintenance treatment with lenalidomide~     alone in maintaining the response.~   "
123062|NCT01956682|"~     The primary objective of this trial is to show that an hypoallergenic infant starter formula~     containing starch and the probiotic L. reuteri decreases the severity of~     regurgitation/spitting-up in infants presenting regurgitation/spitting-up , and who have~     taken it for 4 weeks, in comparison with a standard infant starter formula.~   "
123097|NCT01956227|"~     Falls are a serious health concern for persons with multiple sclerosis (MS). Over 50% of~     persons with MS suffer a fall over a 6-month periodwith the majority of falls resulting in~     medical attention for injuries (i.e., lacerations, bone fractures, & head injuries). The~     effects of a fall are often compounded as it can lead to activity curtailment, physiological~     deconditioning, and institutionalization. Despite the importance of falls in persons with MS,~     the appropriate prevention strategies (i.e. rehabilitation approaches) are not clear. The~     purpose of this investigation is to determine whether exercise based or educational based~     interventions are more suited for fall prevention in older adults with MS.~   "
123063|NCT01956669|"~     The purpose of this study is to find out what effects, good or bad, pazopanib (GW786034),~     National Service Center (NSC) # 737754, has on children, adolescents and young adults between~     12 months and less than or equal to 18 years of age with relapsed or refractory~     rhabdomyosarcoma, non rhabdomyosarcomatous soft tissue sarcoma, Ewing sarcoma, relapsed or~     refractory osteosarcoma, neuroblastoma (measurable and/or evaluable), or hepatoblastoma. This~     is a two-stage open label phase II trial of pazopanib in children, adolescents and young~     adults with recurrent or refractory solid tumors. Eligible subjects will receive pazopanib~     daily as an oral tablet (450 mg/m^2/dose) or as a powder for suspension (225 mg/m^2/dose) in~     28 day cycles. The maximum dose to be administered daily for tablets is 800 mg and for~     suspension 400 mg. Subjects will be closely monitored with clinical and laboratory~     observations for side effects. Response to treatment will be evaluated using appropriate~     imaging studies. In the absence of severe toxicity or progressive disease, subjects may~     continue receiving pazopanib.~   "
123064|NCT01956656|"~     Due to difficulties in maintenance of an effective mechanical oral hygiene regime, effective~     chemical adjunctive measures will likely significantly contribute to overall oral health, the~     function of which should be to augment mechanical plaque control. Traditionally, in Chinese~     medicine the lotus leaf has been used for treating gingival inflammation. An extract of lotus~     leaves have demonstrated significant antibacterial activity against some of the~     periodontopathogens.~   "
123065|NCT01956643|"~     Postoperative ileus is a common after abdominal surgery. Multifactorial etiology such as~     surgical trauma, bowel manipulation and perioperative opioids contributes to delayed return~     of normal gut function Chewing gum has recently been used as a form of sham feeding to~     stimulate acceleration of gut function after abdominal surgery.~      The investigators hypothesize that sham feeding with chewing gum will accelerate return of~     gut function after liver transplantation.~   "
123066|NCT01956630|"~     Allogeneic hematopoietic cell transplantation(Allo-HSCT) is currently an effective treatment~     for Acute leukemia (AL). Relapse after transplantation, being a main obstacle for patient~     survival, is so far treated by second transplantation and donor leukocyte infusion (DLI),~     which seems to have high risk and low survival. Need for a new medication on relapse is~     urgent. The immunotherapy using Dendritic cells (DCs) combined with cytokine induced killer~     (CIK) cells holds promise for the adjuvant treatment of AL to eradicate or control residual~     disease. This randomized study was conducted to evaluate the feasibility and effective of~     genetically modified DCs combining to CIK immunotherapy in relapse AL after allo-HSCT.~   "
123067|NCT01956617|"~     The Shamrock method is a new ultrasound-guided lumbar plexus block. The aim of the study is~     to determine the minimum effective volume of ropivacaine 0.5% required to produce an~     effective lumbar plexus block with this method. Using the Dixon and Massey up-and-down method~     study design, 30 patients scheduled for elective total hip and knee arthroplasty will be~     included in the study.~   "
123068|NCT01956604|"~     Delirium (acute confusional state)is characterized by an acute decline in attention and~     cognition, and is a common clinical syndrome in elderly patients.~      The purpose of this randomised, controlled, parallel group pilot trial is to explore~     superiority of clonidine vs placebo in decreasing delirium in patients diagnosed delirium at~     the acute geriatric ward.~      We will also study the feasibility of oral clonidine in a geriatric ward and effects of~     clonidine upon a variety of outcomes as a means to design a more definite study later.~   "
123069|NCT01956591|"~     Evaluate the long term efficacy and side effects of oxybutynin in the treatment of~     hyperhidrosis.~   "
123070|NCT01956578|"~     This study will evaluate the correlation between the respiratory rate derived from the Reveal~     Insertable Cardiac Monitor (ICM) electrocardiogram (ECG) with the respiratory rate obtained~     from an external respiratory band in patients previously implanted with a Reveal for~     unexplained syncope or suspected arrhythmia.~   "
123071|NCT01956565|"~     The feasibility study will involve mixed methods, this means interviews as well as assessment~     of treatment with inspiratory muscle training therapy (IMT). There are two pathways within~     the study depending on whether people want to have inspiratory muscle training. People who~     accept to have inspiratory muscle training will have assessments before training, after 8~     weeks of training and at 6 month follow up in addition to interviews before and after the~     study (at 6 months). For those who choose not to have the inspiratory muscle training the~     investigators will offer them an interview so that the investigators can find out more about~     what might have made the study more appealing or what treatments they would have preferred.~     The investigators will also ask if they wish to be followed up with baseline assessments for~     the study period and if the investigators can access health records.~      Interviews~      Semi-structured interviews lasting approximately an hour will be performed at the beginning~     of the study with participants who accept the IMT pathway and those who decline IMT until no~     knew themes are raised. These interviews will be used to provide information on reasons for~     declining pulmonary rehabilitation, attitudes to exercise, attitudes to IMT, treatment~     preferences and opinions regarding study design and outcome measures (see Interview Topic~     guide). The interviews will be taped and transcribed verbatim. A follow up interview with~     study participants who have received IMT will be conducted at 6 months addressing attitudes~     to IMT and study design and whether they have decided that they wish to engage with other~     services (such as pulmonary rehabilitation and smoking cessation).~      Inspiratory Muscle Training (IMT) method~      Participants will perform 8 weeks of IMT strength training using the Powerbreathe Kinetic~     device (Powerbreathe). Training will progress to 60% maximum inspiratory pressure (PiMax).~     This means that each breath in through the device is set at 60% of the maximum force you are~     able to create when you breathe in rather than at full force. 30 breaths are performed at~     high velocity (paced initially over a period of 15 minutes to allow recovery between each~     breath through the device). Once established it is anticipated that each training session~     should take no more than five minutes. Training is performed twice a day, 5 days per week for~     the first 8 weeks. Training will be titrated (set to a level suitable for the participant)~     and supervised weekly for the first 8 weeks by a physiotherapist. After 8 weeks training the~     participants are advised to continue training unsupervised, twice a day, 3 times per week for~     a further 18 weeks.~   "
123072|NCT01956552|"~     The primary objective is to compare the phenotype and genotype of the primary tumor with~     those of its metastases in order to optimize the treatment of metastatic disease, in patients~     presenting with first metastatic progression of breast cancer.~   "
123094|NCT01956266|"~     This study investigates a treatment protocol which holds the potential to significantly~     improve communication and quality of life for individuals affected by Parkinson's disease~     (PD). Disorders of emotional communication are widely reported in PD and can negatively~     impact quality of life by increasing social isolation and decreasing independence.~     Individuals with emotional prosodic communication disorders are often perceived as depressed~     or unconcerned about others. This seeming negativity can cause difficulties in relationships,~     and increased feelings of stress and burden in caregivers which may result in earlier~     placement in an institutional care setting. This innovative treatment program could improve~     care for individuals with PD, as well as other individuals who may be affected by disorders~     of emotional prosodic communication (e.g., stroke or traumatic brain injury).~   "
123095|NCT01956253|"~     This study will be a single subject study to evaluate the efficacy of the HER2 kinase~     inhibitor, neratinib, in a patient with metastatic bladder cancer harboring a HER2-GRB7 gene~     fusion.~   "
123073|NCT01956539|"~     Heart failure is the most common heart disease with increasing incidence due to the aging of~     the population is improving the initial prognosis of various conditions that lead to more or~     less progressive heart failure.~      Heart failure is of great variety of clinical and pathophysiological forms necessitating the~     creation of quality records to clarify each of these forms.~      Many types of cardiomyopathies exist, some of which are infrequent but with specific care.~      At the French level, few data exist. In addition, the therapeutic management changes~     regularly.~      New European recommendations (endorsed by the French Society of Cardiology = FSC) were~     published in May 2012. Many therapeutic approaches are being evaluated. The course of care~     and how to take non-drug load (network monitoring, rehabilitation ...) have become important~     issues that have hardly been analyzed by existing records.~      This also leads to better define the different forms of this disease, their natural history~     and methods of management applied in real life. The register of FSC follows the registry of~     the European Society of Cardiology (ESC)Heart Failure (HF) Long Term (CCTIRS No. 11.355bis)~     with inclusions will be completed in November 2012. This new study aims to generate more~     accurate data on a number of points and be more representative for a wider selection of~     patients, the French level.~   "
123074|NCT01956526|"~     The study purpose is to evaluate the safety and feasibility of the CORolla™ TAA in two~     treatment groups, CORolla™ Stand-alone group and  AVR & CORolla™ Add on group.~   "
123075|NCT01956513|"~     The main objective of the study is to assess the sensitivity and the specificity of the~     variation of apparent diffusion coefficient for prediction, after a course of neoadjuvant~     chemotherapy or after modification of the treatment sequence, the pathological response at~     the end of chemotherapy~   "
123076|NCT01956500|"~     The primary purpose of this study is to assess the effect of 8-weeks ingestion of the~     Instaflex Joint Support supplement (Direct Digital, Charlotte, NC) compared to placebo on~     joint pain, stiffness, and function (questionnaires and 6-min walk test) and blood~     inflammation biomarkers in adults with self-reported joint pain.~   "
123077|NCT01956487|"~     Bioequivalence of propafenone hydrochloride capsules manufactured at two different sites~   "
123078|NCT01956474|"~     The purpose of this study is to evaluate the efficacy of ultraviolet-A (UVA)-induced~     cross-linking of corneal collagen (CXL) as a method to increase the biomechanical and~     biochemical stability of the cornea by inducing additional cross-links within or between~     collagen fibers using UVA light and the photo- mediator riboflavin.~   "
123079|NCT01956461|"~     In this study, the investigators would like to analyze the bone mineral density (BMD) , bone~     turnover makers, and fracture prevention effects of daily teriparatide in Japanese patients~     under clinical practice. The participants are treated in the investigators hospital, who are~     under severe osteoporotic condition.~      Several determinants were reported to be related to subsequent BMD increase, such as baseline~     bone turnover markers (BTMs), low BMD at baseline, age, prior treatment, but comprehensive~     discussion is lacking. Specifically, there analyses were performed fragmentarily.~      The main objective of this study is to reveal the determinants of subsequent BMD increase and~     fracture preventing effect by teriparatide.~      Next, in Japan, as the baby boom generation retires, aging and depopulation occur rapidly. As~     a result, there is a lot of nursing home. But there are few reports concerning to the~     efficacy of teriparatide treatment in nursing home patients. The second objective is to~     reveal the efficacy of teriparatide for patients living nursing home, especially BMD changes,~     bone turnover makers change, and adverse events.~   "
123080|NCT01956448|"~     To perform a randomized comparison between the BioMatrix Flex™ and the Resolute Integrity®~     stents in the treatment of unselected patients with ischemic heart disease.~   "
123081|NCT01956435|"~     This pilot study will consist of 10 adult subjects with symmetric idiopathic guttate~     hypomelanosis on the lower legs. Subjects will be randomized to which extremity (right or~     left) will be treated. Treatments with the Xtrac Excimer laser will be performed twice weekly~     for 12 weeks using the typical vitiligo protocol. Our goal is to determine the effectiveness~     of excimer laser for repigmentation of idiopathic guttate hypomelanosis. Effectiveness will~     be graded by the blinded observer scale via photographic comparisons and will be graded by~     subject via survey every 4 weeks.~   "
123082|NCT01956422|"~     Aim of this study is verify if postoperative CPAP after laparoscopic prostatectomy may reduce~     the impact of postoperative respiratory failure, defined as occurrence of hypoxemia (PaO2<60~     mmHg) and/or reduction of Forced Expiratory Volume in 1 second (FEV1) beyond 70% of basal~     value.~   "
123083|NCT01956409|"~     The application of FCH PET in breast cancer diagnosis has not been reported.~      We hypothesize that FCH reveals choline metabolic profiles of breast cancers, and shows the~     similar pathophysiological mechanism to choline on proton MRS, and our study goals are:~        1. To investigate and compare the diagnostic performance of proton MRS and FCH PET for~          localized findings on mammography and breast ultrasound.~        2. To investigate whether FCH PET findings are correlated with choline signals on proton~          MRS.~        3. To evaluate if choline, water and lipid signals on proton MRS, FCH PET are associated~          with factors related to clinical outcome and prognosis- that is, molecular markers,~          tumor staging, histologic grade of breast cancers.~        4. For localized advanced breast cancer, to investigate the treatment response to NAC using~          proton MRS and FCH PET, and to evaluate which modality is more sensitive.~        5. To investigate the usefulness of FCH PET for whole body staging for breast cancer~          patients.~   "
123084|NCT01956396|"~     The protocol, approved by the Medical Research Council, was issued to assess the safety and~     efficacy of the non-surgical device for applying it to the national scale up of adult male~     circumcision in Zimbabwe~   "
123085|NCT01956383|"~     The protocol, approved by the Medical Research Council, was issued to assess the safety and~     efficacy of the non-surgical device for applying it to the national scale up of adult male~     circumcision in Zimbabwe~   "
123086|NCT01956370|"~     The protocol, approved by the Medical Research Council, was issued to assess the safety and~     efficacy of the non-surgical device for applying it to the national scale up of adult male~     circumcision in Zimbabwe~   "
123087|NCT01956357|"~     The aim of this study was to analyse the acute and chronic effects of two aerobic-training~     models performed in water and on dry land on cardiorespiratory, functional, metabolic,~     hormonal and quality-of-life parameters in patients with type 2 diabetes mellitus (T2DM).~   "
123098|NCT01956214|"~     Both strength training and endurance exercise training are commonly prescribed to improve~     strength and function in patients with physical limitations caused by chronic disease or~     disability including chronic kidney disease (CKD). Individuals with CKD often have low~     physical function due to progressive declines in the performance of their kidneys. The low~     physical function leads to physical inactivity, which exacerbates these functional declines~     and promotes cardiovascular disease and bone disorders. In addition, severe functional~     limitations in some patients prevent them from exercising at a great enough intensity to~     provide significant benefits. As a result, alternative strategies are needed to maximize the~     benefits of exercise while decreasing injury risk.~   "
123099|NCT01956201|"~     The purpose of this study is to evaluate the efficacy and safety of Atorvastatin and~     Fenofibrate compared with atorvastatin monotherapy in mixed hypercholesterolemic patients.~   "
123100|NCT01956188|"~     It has been demonstrated that EPA and DHA supplementation may have anti-inflammatory~     properties in several chronic diseases, namely, diabetes, obesity, and in rheumatoid~     arthritis, although not with controversy. Systemic lupus erythematosus (SLE) and~     Antiphospholipid Antibody Syndrome (AAS) are autoimmune diseases characterized by a chronic~     inflammatory state which is associated with the disease´s clinical symptoms. Thus, we~     hypothesized that EPA and DHA supplementation may beneficially affect the inflammatory~     cytokine profile and clinical features of LES and AAS patients.~   "
123101|NCT01956175|"~     The purpose of this study is to evaluate whether electrical pharyngeal stimulation in~     addition to standard care can enhance short-term swallow recovery in tracheostomized~     dysphagic stroke patients and thereby facilitate earlier decannulation compared to sham~     treatment plus standard care.~   "
123102|NCT01956162|"~     Multi-center trial, randomized in 2 parallel groups, open label, with a blinded adjudication~     committee (PROBE methodology), comparing Orthèse Diabète with conventional removable~     devices in terms of healing of ulcers.~      - Primary objective: Evaluate the efficiency of Orthèse Diabète compared to conventional~     removable devices, in terms of the proportion of diabetic patients whose principal ulcer will~     heal completely at 3 months.~   "
123103|NCT01956149|"~     Single-arm study to determine disease control rate in second- (or later) line treatment with~     cabazitaxel after the failure of palliative primary treatment.~   "
123104|NCT01956136|"~     Traumatic brain injury (TBI) is one of the leading causes of serious, life-long disability~     among adolescents and young adults. Especially the cognitive, emotional, and motors deficits~     caused by TBI often impair everyday psychosocial functioning, quality of life and ability to~     work. The purpose of the study is to determine the long-term effect of music-based~     rehabilitation on cognitive, motor, emotional, and social recovery after TBI in adolescents~     and young adults, and to study the neural mechanisms that underlie behavioural recovery and~     the efficacy of music.~   "
123105|NCT01956123|"~     This trial investigates the immunogenicity of FE 999049 in repeated cycles.~   "
123106|NCT01956110|"~     This trial investigates the effects of FE 999049 compared to Gonal-F.~   "
123107|NCT01956097|"~     The objectives of the current study are to evaluate the efficacy and safety of HX106 in~     healthy adults with subjective memory complaints for improving neurocognitive functions and~     to find the changes of brain using magnetic resonance imaging and their associations with the~     neurocognitive function enhancement.~   "
123108|NCT01956084|"~     In this study, investigators are trying to see if LMP specific cytotoxic T lymphocytes (CTLs)~     will prevent or treat disease called Epstein Barr Virus (EBV) Disorder including either~     Hodgkin Lymphoma or non-Hodgkin Lymphoma or Lymphoepithelioma or severe chronic active EBV~     infection syndrome (SCAEBV) or Leiomyosarcoma which has come back or has not gone away after~     treatment, including the best treatment. Investigators are using special immune system cells~     called third party LMP specific cytotoxic T lymphocytes (CTLs), a new experimental therapy.~      Some patients with Lymphoma or SCAEBV or Leiomyosarcoma show evidence of infection with the~     virus that causes infectious mononucleosis Epstein Barr virus (EBV) before or at the time of~     their diagnosis. EBV is found in the cancer cells of up to half the patients with Hodgkin's~     and non-Hodgkin Lymphoma, suggesting that it may play a role in causing Lymphoma. The cancer~     cells (in lymphoma) and some B cells (in SCAEBV) infected by EBV are able to hide from the~     body's immune system and escape destruction. The investigators want to see if special white~     blood cells, called T cells, that have been trained to kill EBV infected cells can survive in~     patient's blood and affect the tumor or infection.~      Investigators used this sort of therapy to treat a different type of cancer that occurs after~     bone marrow or solid organ transplant called post transplant lymphoma. In this type of cancer~     the tumor cells have 9 proteins made by EBV on their surface. They grew T cells in the~     laboratory that recognized all 9 proteins and were able to successfully prevent and treat~     post transplant lymphoma. However in Hodgkin Lymphoma, the tumor cells and B cells only~     express 2 EBV proteins. In a previous study they made T cells that recognized all 9 proteins~     and gave them to patients with Hodgkin Lymphoma. Some patients had a partial response to this~     therapy but no patients had a complete response. They think one reason may be that many of~     the T cells reacted with proteins that were not on the tumor cells. In this present study the~     investigators are trying to find out if the investigators can improve this treatment by~     growing T cells that recognize proteins expressed on EBV infected Lymphoma cells and B cells~     called LMP-1 and LMP2. These special T cells are called third party LMP 1/2 -specific~     cytotoxic T-lymphocytes (CTLs). These LMP-specific cytotoxic~      T cells are an investigational product not approved by the Food and Drug Administration.~   "
123109|NCT01956071|"~     The purpose of this study is to assess full-time workers'impressions and acceptability of a~     prototype pedal desk. The pedal-desk is a semi-recumbent (upright) portable pedal mechanism~     that allows workers to complete tasks in a traditional seated position.~   "
123110|NCT01956058|"~     After a curative treatment by radiotherapy for localized prostate cancer, between 20% and 50%~     of patients may have a biological relapse as a progressive re -rise of PSA. After prostate~     brachytherapy with low flow, this rate is between 2% and 6%. Depending on risk factors~     initially present, some patients will have a micro metastatic disease at the time of re-rise,~     but others will have a true local recurrence purely intra-prostate. Local recurrence after~     radiotherapy is associated with a high incidence of distant metastatic relapse and poor~     overall survival. For these reasons, the possibility of offering a local treatment for this~     selected population of patients can have a major therapeutic interest and allow changing a~     situation often considered palliative to the possibility of a second curative treatment.~      Currently, there is no consensus regarding the optimal management of patients with purely~     local recurrence after prostate irradiation at first intention. When an external radiotherapy~     or brachytherapy is performed as first choice in a patient with prostate cancer, several~     remedial treatments have been proposed, with controversial results the decision-making for~     clinicians and for difficult patients. These main therapeutic options remedial (surgery,~     cryotherapy and brachytherapy) have the potential for complications such as rectal injury,~     impotence or incontinence Brachytherapy is a new salvage treatment being evaluated in the~     United States (Phase II study of the Radiation Therapy Oncology Group No. 0526). Several~     retrospective trials have shown very encouraging results in terms of acute toxicity and~     biochemical control in the short term. Thus, a team from Mount Sinai in New York recently~     published for the first time 10 years retrospective results with this approach. In their~     experience after treatment failures with external beam radiotherapy or brachytherapy, a dose~     of 122 Gy was delivered over 90% of the prostate gland. Doing this they observed biochemical~     control rates and survival specific of 54 % and 96 %, respectively at 10 years, with an~     hormone treatment associated (median 6 months) in 84 % of cases. Four patients had grade 3~     toxicity or higher (11%). To reduce the rate of late toxicities the team from the University~     Of California San Francisco (UCSF), tested focal brachytherapy guided by functional MRI (MRI~     spectroscopy) to re-treat local recurrence after initial brachytherapy as monotherapy or~     boost. By delivering 144 Gy on recidivism objectified on MRI, the authors observed that a~     minimal dose of 37Gy covered 90 % of the prostate gland to treat the risk of microscopic~     disease. Doing this, the rate of observed toxicities and biochemical control appeared~     encouraging, with a median follow-up of 2 years, since no grade 3 toxicity was observed and~     74% of patients achieved a PSA nadir <0.5 ng / mL without associated hormone. In case of~     external radiation or brachytherapy, several attempts proposed to associate an injection of~     hyaluronic acid gel to the prostate - rectum interface to spare healthy tissue irradiated and~     thus reduce the rate of radiation proctitis. The feasibility of implementing this gel has~     been demonstrated in patients with non- irradiated tissues. No inherent toxicity of the~     injection of hyaluronic acid gel has been described after prostate brachytherapy first line.~     The feasibility of this injection remains unproven to date on patients previously irradiated~     externally or by brachytherapy. We hypothesize that the risk of radiation proctitis and~     fistulas front prostate could be reduced using this technique in this indication.~      We propose to carry out a French prospective multicenter phase II trial combining~     brachytherapy remedial with an injection of hyaluronic acid after surgery to reduce the risk~     of radiation proctitis and / or recto -urinary fistula in a patient population hyper-~     selected with a high probability of isolated local recurrence.~   "
123111|NCT01956045|"~     How to determine the decision-making capacity of critically-ill patients remain unclear. The~     investigator study the differences between standardised evaluation and subjective medical~     evaluation.~   "
123112|NCT01956032|"~     The purpose of this study was to evaluate the use of resources during titration of Duodopa at~     home.~   "
123113|NCT01956019|"~     This study will use diffusion weighted MRI (DWI MRI) and dynamic-contrast enhanced MRI (DCE~     MRI) techniques to detect changes in sarcoma tumour vasculature. The main aims of this study~     are to correlate histological response of soft tissue sarcoma after pre-operative~     radiotherapy with several pre-treatment DCE and DWI MRI parameters and to assess the impact~     of these on early response prediction. Detected changes may reflect the sensitivity of the~     tumour to radiotherapy and may be associated with long term outcomes after treatment.~      15 patients normally having pre-operative radiotherapy as part of their sarcoma treatment~     will be recruited to this study.~      Patients will have an additional three specialised MRI scans: one prior to the start of~     radiotherapy, one during the second week of radiotherapy while on treatment and one scan a~     week before surgery but after the completion of radiotherapy.~      Post-operatively, results of the histological examination of the sarcoma will be correlated~     to both the MRI scan data and outcomes after treatment~   "
123317|NCT01953354|"~     The purpose of this study is to evaluate the safety and effectiveness of trichuris suis ova~     (TSO) in ulcerative colitis (UC). We will look at how TSO affects the body's immune response~     and if there are related changes in participants' UC.~   "
123114|NCT01956006|"~     Advanced heart failure (HF), ineffective pumping of the heart, is a common, life-threatening~     cardiovascular disorder, characterised by marked symptomatic limitation and frequent~     hospitalization. It is particularly prevalent in older individuals (up to 10% of the~     population) and it has become the most common cause for hospitalization in people >65yrs. As~     such it is also one of the leading consumers of healthcare spending. Recurrent~     hospitalization is frequently due in significant part to the lack of viable therapeutic~     options for severe HF. During hospital admission, medications through a drip to give through~     a vein (intravenous therapy), is required to improve heart pumping capacity (such as~     milrinone).They are frequently used and in many cases prolonged treatment periods of~     intravenous therapy are required. In a growing number of cases, there is a need to continue~     this treatment at home, however this is particularly costly and often complicated by~     intravenous line infection. As such there is an expanding need for therapeutic options in~     patients with advanced HF. Over 20 years ago, studies of the potential utility of a rapid~     release form of oral milrinone were examined, however these studies demonstrated adverse~     effects due to its quick release.~      This study aims to determine the safety and tolerability of slow release oral milrinone in~     advanced HF patients with no further clinical option and to evaluate its effects on HF~     status.~   "
123115|NCT01955993|"~     Fentanyl is a frequently used pain medication in pediatric and adult anesthesia. Although~     there are some studies considering the breakdown of oral, transmucosal and intravenous~     fentanyl preparations in children, the disposition of fentanyl in pediatric patients has not~     been sufficiently described. This study aims to show that the clearance of fentanyl in obese~     children and adolescents is increased as compared to children with a normal weight.~     Consequently, the elimination half-life of fentanyl is different in overweight and obese~     children from that in children having a normal body weight.~   "
123116|NCT01955980|"~     The study should create data for the selection of a clinically relevant endpoint to assess~     the potential of Buparid/PARI SINUS to postpone sinus surgery in patients with chronic~     Rhinosinusitis.~   "
123117|NCT01955967|"~     The aim of this randomized double blind, placebo controlled, crossover study is to~     investigate in a prospective way the effect of lidocaine in patients with trigeminal~     neuralgia. Included patients will undergo four weekly sessions, two of which with lidocaine~     (5mgs/kg) and two with placebo infusions administered over 60 minutes. Effect will be~     measured with pain diaries and visual analogue scales.~   "
123118|NCT01955954|"~     The purpose of this study is to test the effectiveness of the Canary Breathing System (CBS)~     in treating the symptoms of panic disorder.~   "
123119|NCT01955941|"~     The purpose of this study is to learn how blood flows to tumors in patients treated with~     I-125 plaque brachytherapy for uveal melanoma.~   "
123120|NCT01955928|"~     The object of this study is to compare internet-delivered treatment for insomnia to a~     waiting-list. In this study participants are randomized to: 1) online cognitive-behavioral 2)~     waiting-list. Participants in the waiting-list condition receive treatment after the~     post-test. The interventions consist of: diary; psycho-education; relaxation exercises;~     stimulus control/sleep hygiene; sleep restriction; challenging the misconceptions about~     sleep; and paradoxical exercise. Adult persons with insomnia will be invited via a popular~     scientific website to fill out online questionnaires. Participants will fill out~     questionnaires and a dairy at baseline post-test, 3-month follow-up, and 6-month follow-up.~     In this study we are interested in sleep-related worry and daily complaints measured with a~     diary. We expect that the online intervention ameliorates both the sleep-related worry and~     the daily complaints. Furthermore, we expect that the sleep related worry mediates the effect~     of the intervention on sleep- and daily complaints.~   "
123121|NCT01955915|"~     The purpose of this study is to see if mapping blood vessel patterns with optical coherence~     tomography (OCT) will help identify life-threatening choroidal tumors in their early stages~     and improve overall patient survival through early detection.~   "
123122|NCT01955902|"~     The purpose of the proposed study is perform focus groups to identify and prioritize features~     of the SubAID application (APP). The SubAID APP is smartphone APP being created to support~     patients self-managing buprenorphine/naloxone (bup/nal) medication. Many people have~     difficulty in managing bup/nal in the prescribed manner. Not taking medicines in their~     prescribed manner can cause negative health outcomes.~      Focus group participants will be asked to elaborate on medication-taking patterns that work~     best for them, pitfalls associated with poor adherence and offer opinions upon what~     features/functions the SubAID APP should perform to be most helpful to them. The focus group~     is designed to remain open-ended and allow free discussion regarding each particular topic~     that the moderator will bring up.~   "
123123|NCT01955889|"~     Persons with Parkinson Disease (PD) face significant declines in function resulting in~     greater disability. Function can improve through participation in exercise, yet many people~     with PD are physically inactive. Given that people with PD live long lifespans following~     diagnosis; it is essential to include routine exercise into their lives over the long-term.~     Physical therapy is effective in improving function in persons with PD. However,~     participation in on-going physical therapy indefinitely is not a realistic option due to~     limited healthcare resources. Interventions using mobile health technologies allow physical~     therapists to stay connected to patients over time potentially improving their ability to~     meet the changing needs of patients with PD. Innovative approaches using mobile health~     technology may improve outcome; however, the effectiveness of different approaches to improve~     function and reduce disability in PD is unknown.~      The purpose of this study is to compare the effectiveness of two interventions to improve~     function and health-related quality of life in 65 people with PD. In one study group,~     participants receive a home exercise program, in written format, to continue on an~     independent basis. In the other study group, participants are instructed to continue with an~     exercise program, in their home, delivered using videos of the exercises on a computer tablet~     device. This use of mobile-Health technology allows the physical therapist to remotely~     monitor participants' progress and modify the exercise program to meet the changing needs of~     each patient. The long-term objective of this research is to determine the most efficient and~     effective way to improve function that can be widely disseminated to persons with PD.~   "
127181|NCT01902732|"~     This clinical trial evaluates the impact of catheter-based measurement of interloabr~     collateral ventilation prior to endoscopic lung volume reduction in patients with~     hetereogeneous emphysema and complete interlobar fissures in high resolution computed~     tomography.~   "
123124|NCT01955876|"~     This study is a regulatory post-marketing surveillance in Japan and it is a local prospective~     and observational study of patients who have received Fosrenol.~      The objective of this research is to collect information on the safety of Fosrenol after its~     launching, which means collecting information on adverse events, especially adverse events in~     the digestive system including constipation and serious adverse events, and adverse drug~     reactions when the drug is administered to the below-mentioned target patients for six~     months.~      The secondary objective is to collect information on the safety of the drug when administered~     for more than six months, which means collecting information on the safety of the drug when~     administered for up to 12 months to the target patients who have already been treated with~     the drug for six months. And also if at the time of 12 months after administration of~     Lanthanum carbonate the dialysis is not conducted, extending its' administration will be~     continued until conduction of dialysis, or until Sept. 30, 2015. The efficacy of fosrenol is~     evaluated by observing the serum P(phosphorus) level and serum PTH (parathyroid hormone)~     level change.~   "
123125|NCT01955863|"~     Radical prostatectomy has become the gold standard treatment for prostate cancer.~      Regarding of morbidity of access on open retropubic radical prostatectomy a lot of centers~     around the world start to develop laparoscopic and robotic approach over the past years. The~     problems regarding this techniques is that the pure laparoscopic prostatectomy shows a steep~     learning curve with a high initial complication rate, and the use of robotic assistance~     surgery despite of lower learning curve is associated with higher surgical supply and~     operative room costs. These costs may have a significant impact on overall cost of prostate~     cancer care especially in Brazil.~      In Brazil, the open route for radical prostatectomy is still the most frequent approach. One~     of the disadvantages of open prostatectomy from the other surgeries is the longest hospital~     stay. However, the question of what length of stay after this operation is optimal and~     necessary is unresolved. In this trial the investigators have compared a randomized group of~     patients that had discharged on postoperative day 2, 1 and same day surgery. The~     investigators had intent to evaluate the feasibility of ambulatory open radical prostatectomy~     (patient discharge in the same day of surgery - average 12 hours of hospitalization)~     maintaining patient satisfaction and safety.~   "
123126|NCT01955850|"~     The object of this study is to compare internet-delivered treatment for insomnia to~     face-to-face treatment and a waiting-list. In this study participants are randomized to: 1)~     online cognitive-behavioral intervention; 2) face-to-face cognitive behavioral intervention;~     3) waiting-list. Both the online and face-to-face interventions consist of: diary;~     psycho-education; relaxation exercises; stimulus control/sleep hygiene; sleep restriction;~     challenging the misconceptions about sleep; and paradoxical exercise. Adult persons with~     insomnia will be invited via a popular scientific website to fill out online questionnaires.~     Participants fill out questionnaires and a dairy at baseline post-test, 3-month follow-up,~     and 6-month follow-up. Participants on the waiting-list receive online treatment after the~     first post-test. The investigators expect that the online-delivered treatment and the~     face-to-face treatment are equally effective.~   "
123127|NCT01955837|"~     To compare the effects of TAS-102 with placebo in patients with metastatic colorectal cancer~     refractory or intolerable to standard chemotherapies.~   "
123128|NCT01955824|"~     Flexible bronchoscopy is a common procedure performed by pulmonary physicians. The use of~     topical anesthesia, analgesia, and sedation during flexible bronchoscopy varies among~     physicians, institutions and geographic locations across the globe. Commonly used topical~     anesthetic agents before and during bronchoscopy include cocaine (4%),benzocaine (20%),~     tetracaine (1%), and lignocaine (1%-10%). Topical lignocaine is administered through the~     flexible bronchoscope in an attempt to reduce excessive coughing and patient discomfort.~     However, the optimal dosage and strength of topical lignocaine that should be used during~     fibreoptic bronchoscopy has long been a topic of controversy. In this study we compare the~     efficacy of 1% versus 2% lignocaine in controlling cough and pain in patients undergoing~     flexible bronchoscopy.~   "
123129|NCT01955811|"~     Patients with need of platelet transfusion for any reason will participate in this study.~     Directly before the start of infusion and one hour after the end of platelet transfusion~     blood samples will be drawn and treated with different concentrations of Fibrinogen (a blood~     clotting factor) in-vitro. Blood samples with and without Fibrinogen/platelet transfusion~     will be compared. The study hypothesis is that treatment with Fibrinogen results in a better~     stabilisation of blood coagulation.~   "
123130|NCT01955798|"~     The Veress needle is the laparoscopic entry technique most commonly used among gynecologists.~     Direct trocar entry is another method to gain entry to the abdomen that is uncommon to~     gynecologists.~      This prospective and randomized study will compare the two entry techniques with regard to:~        -  Complications related to the entry technique and previous surgeries~        -  Time taken to enter the abdomen~        -  The number of attempts taken to enter the abdomen~   "
123131|NCT01955785|"~     Intracranial pressure (ICP) in patients with traumatic brain injury (TBI) is influenced by~     several factors of which one is arterial CO2 tension. Patient with TBI are often sedated and~     mechanically ventilated in order to secure a stable PaCO2. This study compares two~     ventilation modus; Pressure Controlled Ventilation (PC) and Pressure Regulated Volume~     Controlled ventilation (PRVC) in order to observe which of the two ventilation strategies~     results in a more stable ICP and arterial CO2 pressure (PaCO2).~   "
123144|NCT01955616|"~     The purpose of this study, called MOVE-PD, is to investigate how individuals with Parkinson's~     disease (PD) and chronic constipation (CC) respond to RM-131 as compared to placebo. The~     study will look at how well RM-131 affects the frequency of spontaneous bowel movements over~     a 14-day period. The study will also evaluate the safety and tolerability of the study drug~     and evaluate whether the study drug relieves the uncomfortable GI symptoms related to chronic~     constipation in patients who are unsatisfied with other therapies they have tried for~     constipation.~   "
123145|NCT01955603|"~     This trial is conducted in Europe. The aim of the trial is to investigate the safety,~     tolerability, pharmacokinetics (exposure of the trial drug in the body) and pharmacodynamics~     (the effect of the investigated drug on the body) of NNC0215-0384 administered to subjects~     with moderate to severe rheumatoid arthritis (RA) concomitantly treated with methotrexate~     (MTX).~   "
144238|NCT01679392|"~     In this study we investigate the following properties of the transversus abdominis plane~     block in healthy volunteers:~        1. Cutaneous analgesic distribution~        2. Muscular affection~        3. Reproducibility~   "
123132|NCT01955772|"~     Myeloablative allogeneic hematopoetic stem cell transplantation (AHSCT) are prone to frequent~     secondary malnutrition to metabolic and digestive troubles due to conditioning regimen,~     treatments (antibiotics, immunosuppressive therapy…) and graft complications (graft versus~     host disease). In the absence of appropriate nutritional support, myeloablative conditioning~     lead to a rapid serious denutrition. But, it is known as negative independent prognostic~     factor of overall survival of patients who presented malignant hemopathy treated by high-dose~     chemotherapy or AHSCT. Furthermore, it increases hospitalisation delay and decreases quality~     of life. In AHSCT with myeloablative conditioning, introduction of nutritional support is~     recommended. However, type of nutritional support remains not clearly defined. Parenteral~     nutrition is user but favour infections and secondary effects potentially decrease by~     intravenous glutamine. Few previous studies with low number of patients, mainly retrospective~     or combining allo-and auto HSCT had shown feasibility, acceptable tolerance and low cost of~     enteral nutrition (EN). A recent prospective no-randomized study in 45 adults patients who~     had undergone AHSCT with myeloablative conditioning find a significant decrease of day-100~     mortality (5% vs 30%), of infection mortality, of median duration of parenteral nutrition~     (PN) and prevalence of GvH (Graft versus Host Disease) grade III-IV in EN (enteral nutrition)~     group. These results had to be confirmed by a randomized study. As EN is 4 to 5 more cheaply~     than PN, besides mortality/morbidity stakes for the patient, this study could have potential~     economic interest.~   "
123133|NCT01955759|"~     The aim of the study is to evaluate whether combined therapy with beta-blocker, amiodarone~     and statine is better than beta-blocker alone for the prevention of atrial fibrillation after~     coronary by-pass surgery.~   "
123134|NCT01955746|"~     The purpose of this study is to explore the susceptible genes for Type 1 diabetes in Taiwan~     through the new genetic study methods.~   "
123135|NCT01955733|"~     The primary objective of this trial is to evaluate the long-term safety of BI 695500 in adult~     patients with moderately to severely active rheumatoid arthritis (RA) who have successfully~     completed treatment in Trial 1301.1.~   "
123136|NCT01955720|"~     To investigate safety, tolerability, PK and PD of BI 655075 and to establish the BI 655075~     dose(s) effective to reverse prolongation of blood coagulation time by dabigatran~   "
123137|NCT01955707|"~     The primary objective of the study is to determine whether one 300 mg dose of intravenous~     (IV) natalizumab reduces change in infarct volume from Baseline to Day 5 on magnetic~     resonance imaging (MRI) in participants with acute ischemic stroke when given at ≤6 hours or~     at >6 to ≤9 hours from when they were last known normal (LKN).~      The secondary objectives of this study in this study population are as follows: to assess the~     efficacy of natalizumab on change in infarct volume from Baseline to Day 30; to assess~     efficacy of natalizumab on change in infarct volume from 24 hours to Day 5 and Day 30; to~     assess the efficacy of natalizumab on clinical measures of stroke outcome; to assess the~     safety of natalizumab in participants with acute ischemic stroke.~   "
123138|NCT01955694|"~     This study will be conducted in subjects with clinical diagnosis of worsening chronic heart~     failure and either type 2 diabetes mellitus (DM) with or without chronic kidney disease (CKD)~     or moderate CKD alone treated with evidence-based therapy for heart failure (HF) for at least~     3 months prior to emergency presentation to hospital using a multi-center, randomized,~     adaptive, double-blind, double-dummy, comparator-controlled, parallel-group design.~      Primary objective of the study is to investigate efficacy [percentage of subjects with a~     relative decrease in N-terminal prohormone B-type natriuretic peptide (NT-proBNP) of more~     than 30% from baseline to Visit 10 (Day 90)] and safety of different oral doses of BAY94-8862~     given once daily.~   "
123139|NCT01955681|"~     This is a retrospective, non-interventional, multicenter, observational chart review study to~     explore the clinical benefits of retreatment with TKI in the real world.~   "
123140|NCT01955668|"~     In Part A to investigate the safety and tolerability of AZD6738 when given orally to patients~     with relapsed/refractory CLL, PLL or B cell lymphoma.~      In Part B to investigate the safety and tolerability of AZD6738 when given orally to patients~     with prospectively identified 11q deleted or ATM deficient, relapsed/refractory CLL~   "
123141|NCT01955655|"~     This is a study of recurrent crying spells in Spastic Cerebral Palsy patients and their~     treatment.~   "
123142|NCT01955642|"~     Ischemic stroke (AIC) is the leading cause of non-traumatic disability in adults, the second~     leading cause of dementia and the third leading cause of death in France.~      Clopidogrel is one of the recommended first line in the secondary prevention of AIC non~     cardioembolic origin. However recurrences occur in approximately 9% of patients receiving~     clopidogrel. Some studies in patients with coronary artery disease have made the connection~     between these treatment failures and non-biological response to clopidogrel. This~     non-biological response is found for approximately 30% to 50% of patients. Several mechanisms~     may explain this non-response. The most accepted mechanism is pharmacokinetic. Indeed,~     clopidogrel is a prodrug that requires intestinal absorption by P-glycoprotein (PGP) and a~     transformation by hepatic cytochrome into active metabolites. The genetic polymorphism of~     proteins involved in these two steps explain the low plasma concentration of active~     metabolites and thus the low efficacy of clopidogrel in some patients.~      A new pharmacodynamic hypothesis suggests the involvement of platelet alpha 2-adrenergic~     receptors. The activation of these receptors potentiates signaling pathway P2Y12 receptor~     (channel inhibited by clopidogrel) and helps reduce platelet aggregation inhibiting response~     to clopidogrel.~   "
123143|NCT01955629|"~     Primary Objectives:~      Study Part 1: To determine the recommended dose for the aflibercept, oxaliplatin and~     capecitabine (XELOX) combination to be used in the Part 2 of the study.~      Study Part 2: To assess the percentage of participants without progression of the disease at~     6 months after the start of maintenance therapy with aflibercept single-agent, following the~     first-line induction therapy with XELOX and aflibercept combination in participants with~     previously untreated metastatic colorectal cancer.~      Secondary Objective:~      Study Part 2: Include the evaluation of progression free survival, overall survival, response~     to treatment, the overall safety (during induction and maintenance therapy) and the~     assessment of aflibercept pharmacodynamics and biomarkers parameters.~   "
123255|NCT01954173|"~     This phase II trial studies how well modern, conformal radiation therapy after surgery works~     in treating patients with high-risk bladder cancer. Specialized radiation therapy that~     delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause~     less damage to normal tissue.~   "
123146|NCT01955590|"~     Posttraumatic stress disorder (PTSD) is a frequently occurring and often debilitating anxiety~     disorder resulting from exposure to trauma. Trauma-focused cognitive-behavioural therapies,~     such as Eye movement desensitization and reprocessing (EMDR), are generally considered to be~     evidence-based treatments for PTSD. Although a majority of patients achieve improvement, a~     substantial minority either drop out of treatment, present with residual symptoms following~     treatment or fail to make any improvement. Furthermore, a substantial portion of the clinical~     trials on PTSD is characterised by major methodological limitations. In addition, there's a~     pressing need for research on mediators of treatment outcome. Taken together, these results~     highlight the need for methodological rigorous and stringent clinical trials comparing~     treatment modalities for PTSD. The first aim of this study is to investigate whether a~     treatment not based on the principles of exposure, i.e. metacognitive therapy (MCT) is as~     efficient as exposure-based treatments. The second aim to elucidate potential mediators of~     treatments effects by incorporating process-related variables.~   "
123147|NCT01955577|"~     The purpose is to study:~        1. the frequency of vitamin D deficiency at patients with tibial fracture treated with an~          external ring fixator~        2. if vitamin D supplement facilitates fracture healing~        3. a possible relation between vitamin D deficiency and the risk of complications and the~          time of fracture healing~   "
123148|NCT01955564|"~     This is a prospective, 8-day, randomized, double-blind, placebo-controlled, sequential-cohort~     study designed to evaluate the safety, tolerability, and MTD of single escalating oral doses~     of NW-3509A in healthy male volunteers. Six independent cohorts of 12 volunteers each will~     participate in this study, with the first 9 volunteers in each cohort to qualify being~     randomized to receive study medication and the remaining 3 to be used as backups/ alternates.~     In each cohort, 6 subjects will be randomly assigned to receive NW-3509A and 3 subjects will~     receive placebo.~   "
123149|NCT01955551|"~     Evidence-based programs aimed at enhancing parenting skills are effective, and pediatricians~     identify many parents who could benefit from such programs. Low-income children have high~     rates of behavior problems and their family system and environmental exposures often lead to~     cumulative and daunting levels of risk for poor functional outcomes; their parents are highly~     likely to benefit from parenting supports. However, low-income families are the most likely~     to drop out of parenting interventions, meaning the families and children with the greatest~     need receive the least support. Fewer than 25% of low-income families recruited to parenting~     programs will participate in even one session, and only about half of these parents will~     participate in more than half of the sessions offered. The aims of this trial are:~      Aim 1: To test the hypothesis that the provision of motivational interviewing (MI), as~     compared to an attention control (AC) condition, will increase the engagement of low-income~     parents of preschoolers in an evidence-based parenting skills group (the Incredible Years~     Series (IYS)). For this study, the outcome of engagement is operationally defined as~     intention to attend IYS sessions, attendance, and satisfaction with the IYS program.~      Aim 2: To test the hypothesis that the effect of MI on engagement in IYS will be impacted by~     the following moderators: parenting self-efficacy, child behavior problems, and maternal~     depression.~      The investigators hypothesize that the effect of MI on engagement will be greater among~     parents with lower parenting self-efficacy and parents of children with more behavior~     problems, but less among parents with more maternal depressive symptoms.~      The investigators will use a stratified, randomized controlled trial (RCT) design to evaluate~     the impact of MI on parent engagement in a well-validated preventive parenting skills~     intervention, the Incredible Years Series (IYS).~   "
123150|NCT01955538|"~     The aim of this randomised controlled trial is to study two types of physical activities as~     add-on treatment, compared to treatment as usual for traumatised refugees. Hereby, the study~     will examine the evidence of an often-used treatment modality in a field where very little~     research yet has been conducted.~   "
123151|NCT01955525|"~     This study is aiming to i)measure longterm health related quality of life (HRQL) outcomes of~     the EMMACE3 patients hospitalised with acute coronary syndromes (ACS) and evaluate possible~     associations with their cardiovascular profile and to ii) Linkage these data to multiple~     electronic healthcare records~   "
123152|NCT01955512|"~     In asthma, breathing in an allergen, such as house dust mite induces inflammation in the~     airways. This process appears to involve an interaction between two different sorts of blood~     cells, platelets and white blood cells via a receptor called the P2Y12 receptor. The purpose~     of this study is to determine whether the drug clopidogrel which blocks the P2Y12 receptor on~     platelets, reduces inflammation following breathing in house dust mite in people with mild~     asthma.~   "
123153|NCT01955499|"~     This phase I trial studies the side effects and best dose of lenalidomide and ibrutinib in~     treating patients with B-cell non-Hodgkin lymphoma that has returned or not responded to~     treatment. Biological therapies, such as lenalidomide, may stimulate the immune system in~     different ways and stop cancer cells from growing. Ibrutinib may stop the growth of cancer~     cells by blocking some of the enzymes needed for cell growth. Giving lenalidomide with~     ibrutinib may work better in treating non-Hodgkin lymphoma.~   "
123154|NCT01955486|"~     The purpose of this study is to gather more information on Eustachian tube function and~     middle-ear pressures during flying. Ten subjects with tympanostomy tubes (plastic tubes~     inserted in the eardrums) in their ears or holes in their ear-drums will undergo flight~     simulation in a pressure chamber. Their middle-ear pressures and Eustachian tube function~     will be monitored at various chamber pressures.~   "
123155|NCT01955473|"~     This trial is to assess the safety and tolerability of Sym004, administered weekly or~     biweekly as monotherapy in Japanese subjects with advanced solid tumors.This study consisted~     of two parts, a dose-escalation part (Part-A) and a dose-expansion part (Part-B). In~     Part-A, Sym004 will be administered weekly or biweekly as monotherapy in Japanese subjects~     with advanced solid tumors. In Part-B, Sym004 will be administered weekly as monotherapy to~     Japanese subjects with advanced esophageal squamous cell carcinoma (ESCC) as dose-expansion.~     A subject will receive Sym004 administration weekly at a dose that will determined to be the~     MTD or a dose that will lower than the MTD and determined to be appropriate with~     recommendation by Safety monitoring committee (SMC). The dose going to used in Part-B will be~     determined after safety confirmation of weekly regimens in Part-A of this trial.~   "
123156|NCT01955460|"~     The goal of this clinical research study is to find the highest tolerable dose of T-cells~     injected with the genes TGFb-DNR and NGFR that can be given in combination with chemotherapy~     (cyclophosphamide and fludarabine) and aldesleukin to patients with metastatic melanoma.~      This study involves gene therapy. T-cells are types of white blood cells that help your body~     fight infections. They may recognize and kill melanoma cells. Researchers want to grow your~     T-cells in a laboratory, inject them with TGFb-DNR and NGFR genes which may help them~     recognize tumor cells, and then give them back to you by vein. This may help to control~     melanoma.~   "
123157|NCT01955447|"~     The study is designed to determine the extent to which foods containing different levels of~     plant-based ingredients affect blood glucose responses in healthy subjects.~   "
123158|NCT01955434|"~     This phase II trial studies how well second mitochondrial-derived activator of caspases~     (SMAC) mimetic LCL161 alone or with cyclophosphamide works in treating patients with multiple~     myeloma that has returned or does not respond to treatment. Biological therapies, such as~     SMAC mimetic LCL161, may stimulate the immune system in different ways and stop cancer cells~     from growing. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to~     stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. It is not yet known whether giving SMAC mimetic LCL161 alone or with~     cyclophosphamide is more effective in treating multiple myeloma.~   "
123159|NCT01955421|"~     This study is a multicenter, randomized, open-label Phase II trial that compares reduced dose~     erlotinib 100mg daily and standard dose gefitinib 250mg daily in patients with advanced~     non-small cell lung cancer who harbor EGFR mutations. The primary endpoint is disease control~     rate (DCR) and the key secondary endpoint is progression free survival (PFS). A total of 224~     eligible patients will be randomized to receive either erlotinib 100mg daily or gefitinib~     250mg daily in a 1:1 ratio until patients experience disease progression. Independent~     assessment of the major endpoints will be completed in a treatment-blinded manner.~     Randomization will be stratified based on treatment-lines (first-line vs. maintenance vs.~     second-line therapy). Tumor response and progression will be assessed according to RECIST~     1.1.~   "
123160|NCT01955408|"~     Bladder carcinoma is the most common malignancy of the urinary tract. Approximately 75-85% of~     patients with bladder cancer present with a disease that is confined to the mucosa or~     submucosa. These categories are grouped as non-muscle-invasive bladder tumors(i.e.~     superficial tumors).~      Bladder cancer is the fifth most common cancer in the United States, with an estimated 67,160~     newly diagnosed cases and 13,750 deaths in the United States in 2007. The 5-year survival~     rate is 82% for all stages combined. The standard of treatment for patients with superficial~     bladder cancer is surgical transurethal resection (TUR) of tumors, with an 80% early success~     rate. However, nearly 70% of these patients will develop tumor recurrence, with 25% showing~     progression to muscle-invading disease, within 5 years with TUR.~      It is therefore necessary to consider adjuvant therapy in all patients. The absolute risks of~     recurrence and progression do not always indicate the risk at which a certain therapy is~     optimal. The choice of therapy may be considered differently according to what risk is~     acceptable for the individual patient and the urologist.~      Intravesical chemotherapy and immunotherapy are widely used as adjuvant therapies after TUR,~     to prevent recurrence and progression of superficial disease. Systemic therapy is typically~     reserved for higher stage, muscle-invading, or metastatic diseases. The urinary bladder is an~     ideal organ for regional therapy.~      The urethra provides easy access of therapeutic agents to the urinary bladder. The presence~     of the specialized asymmetric unit membrane on the urothelium serves as a barrier and limits~     the absorption of molecules or particulates into the systemic circulation.~      The rationale for intravesical therapy is to maximize the exposure of tumors located in the~     bladder cavity to therapeutics agents while limiting the systemic exposure and thereby~     limiting the host toxicities; the primary goal is to eradicate existing or residual tumors~     through direct cytoablation or immunostimulation. The unique properties of the urinary~     bladder render it a fertile ground for evaluating novel approaches to regional therapy,~     including local hyperthermia, co-administration of permeation enhancers, bioadhesive~     carriers, and gene therapy.~      One of the developing treatments for high-risk superficial bladder cancers is the combination~     of intravesical chemotherapy and hyperthermia (HT), called chemohyperthermia (C-HT). The most~     common form of C-HT uses the Synergo HT system, in which local HT is administered via direct~     microwave irradiation of the urothelium by means of a 915-MHz intravesical microwave~     applicator. The target intravesical temperature is set between 41.8C and 44.8C and is~     measured by five thermocouples integrated in a 20-F treatment catheter. To avoid injury, the~     urethra is continuously cooled. Due to extensive global experience with its use and a~     significant amount of preclinical data demonstrating improved antineoplastic efficacy when~     heated, mitomycin C (MMC) is the most common intravesical chemotherapy agent used in~     conjunction with HT.~      The most common adverse events during treatment were bladder spasms and bladder pain.~     Literature reports bladder spasms in 21.6% of patients, and bladder pain in 17.5%. Bladder~     spasms tended to occur more frequently with the prophylactic schedule, whereas pain was~     present equally in the prophylactic and ablative schedules but more commonly after the~     ablative schedule. In the first days following C-HT, storage LUTS (frequency, dysuria,~     urgency, nocturia) (25.6%) and hematuria (6.0%) are the most common adverse events. Most~     studies mention that these symptoms were mild and transient, resolving spontaneously within a~     few days of treatment. One study described severe cystitis complaints in three patients~     (16%), but other studies have not confirmed these adverse events. Two studies report the~     development of a contracted bladder and severe urinary incontinence after ablative C-HT.~     However, the possibility cannot be excluded that previous transurethral resection and~     intravesical chemotherapy might have contributed to this event.~      Following the appearance of bothersome storage LUTS, patient should be managed by existing~     guidelines. Based on AUA/SUFU Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic)~     in Adults Guidelines published in 2012 patients should be diagnosed, followed and treated~     according to the suggested algorithm.~      In our study, we would like to assess the severity of OAB symptoms and their response to a~     standard OAB treatment according to AUA Guidelines for Non-neurogenic OAB as well as to~     assess urodynamic study variables in those who didn't respond to a standard medical treatment~     and bothered by their OAB symptoms.~   "
123161|NCT01955395|"~     This research study is evaluating the effects of a mind body medicine intervention called the~     Relaxation Response Resiliency Program (3RP) on stress and stress related symptoms in~     patients with monoclonal gammopathy of undetermined significance (MGUS) and smoldering~     multiple myeloma (SMM).~      This research study is a supportive care trial. This means that the intervention program may~     improve general well-being and comfort, but is not considered a treatment or cure for MGUS~     or SMM. It is considered an investigational intervention because the investigators are~     examining the effectiveness of a new program - the 3RP - on reducing stress and~     stress-related symptoms in patients with MGUS and SMM. Standard management of MGUS and SMM~     involves regular monitoring without chemotherapy. Mind-body medicine, as defined by the~     National Institutes of Health, focuses on the interactions among the brain, mind, body, and~     behavior, and on the powerful ways in which emotional, mental, social, spiritual, and~     behavioral factors can directly affect health. The 3RP is a newly designed group therapy~     program that through a variety of mind body principles and self-care interventions seeks to~     buffer stress and promote psychological resiliency and physical well-being.~      This study will examine the effectiveness of the 3RP in reducing stress and symptoms~     associated with stress in patients diagnosed with MGUS or SMM. Data from this study will also~     be used to assess changes in gene expression that result from 3RP intervention, particularly~     genetic pathways that are known to be dysregulated in MM.~   "
123162|NCT01955382|"~     Background:~      - Malaria is caused by small parasites carried by some mosquitoes. People can get malaria if~     an infected mosquito bites them. Malaria destroys red blood cells. Most malaria is mild, but~     some children develop severe malaria, which kills about 660,000 people annually. About 9 in~     10 who die of malaria are Sub-Saharan African children, most under 5 years old. Scientists~     can save many lives if they find out how to prevent or relieve severe malaria.~      Objective:~      - To know if a common medicine called activated charcoal can reduce severe malaria symptoms.~      Eligibility:~      - Children 2 to 11 years old with mild malaria who live in Kenieroba, Mali.~      Design:~        -  For the first 2 days and nights, participants will stay in the hospital.~        -  They will have their medical history taken, and a physical exam.~        -  Blood will be drawn from a thin tube inserted in their hand or forearm. This will be~          done 3 times overall. A drop of blood will be taken from a finger prick 12 times~          overall.~        -  An antimalarial drug will be injected into the tube in the arm 4 times. Each time the~          drug is given, participants will drink a small cup of either water or activated~          charcoal.~        -  For the following 3 days, participants will take an antimalarial pill.~        -  On day 7, participants will visit the hospital. A drop of blood from a finger prick will~          be tested for malaria parasites.~   "
123163|NCT01955369|"~     There is a lack of prospective and population-based epidemiological data on amyotrophic~     lateral sclerosis in Germany so far. The purpose of this registry is to investigate the~     incidence, course and phenotypic variety of ALS in Rhineland-Palatinate, a South-West German~     state of about 4 million inhabitants.~   "
123164|NCT01955356|"~     Some studies have revealed that an induced endometrial injury could improve embryo human~     implantation in patients with implantation failure.~      The purpose of this study is to determine whether the induced endometrial injury could be~     beneficial for regular patients undergoing IVF~   "
123165|NCT01955343|"~     This study is designed to evaluate the importance of the immune cells localization~     (distribution) between malignant tumor islets and surrounding stroma and to investigate the~     associations between these immune cells as well as cytokines and clinicopathological and~     prognostic factors of non-small cell lung cancer (NSCLC) patients.~   "
123166|NCT01955330|"~     OBJECTIVES:~      The objectives of the year study are two-fold:~        1. To determine the 5-7 year patency rate (rate of open bypass grafts) of the LITA graft~          and stent of patients who have already had robotically-assisted Hybrid CABG surgery~          using CTA and MPS-MIBI.~        2. To determine patient quality of life at 5-7 years after robotically-assisted Hybrid CABG~          surgery~   "
123187|NCT01955057|"~     Persistent smoking after lung cancer has been the subject of medical, therapeutic and~     epidemiological publications for twenty years of research. Continued persistent smoking is~     all the more a problem for oncologists as there is evidence that smoking cessation, with lung~     cancer, gives therapeutic benefit. Quitting smoking can improve the response to treatments~     (chemotherapy, radiotherapy, surgery), quality of life and overall survival. However many~     patients refuse adhesion to tobacco cessation. Daily practice leads us to the hypothesis that~     adhesion differences aren't related to the denial of medical information, nor to resignation~     or to nicotine dependence. Patients who continue smoking seem to face a form of impossibility~     to wean. Cigarette seems to be felt as a part of their body in their narration and~     description of their body image.~   "
123188|NCT01955044|"~     The purpose of this study is to determine if buccal administration of a concentrated~     formulation of long-chain polyunsaturated fatty acids (LCPUFA) can help to maintain~     docosahexaenoic acid (DHA) levels in extremely low birth weight (ELBW) infants.~   "
123167|NCT01955317|"~     Background (brief):~        1. Burden:~           Neonatal death still unacceptably high in low income countries. The common causes of~          neonatal death are pneumonia, sepsis and omphalitis. Many neonatal infections occur~          because the mother's hands or the hands of the person who attended the birth are~          unclean. Our previous study found that there was substantial concern about excessive~          exposure of the mother or the neonate to water during handwashing because of the~          perception that frequent contact with water could lead to respiratory illness.~        2. Knowledge gap:~           Chlorhexidine has been evaluated for use in hand hygiene applications in high-income~          countries, particularly in healthcare, but it has not been evaluated or promoted for~          hand cleansing at the household level in low- and middle-income countries.~        3. Relevance:~      A waterless hand cleanser employing chlorhexidine would overcome important barriers to~     handwashing with soap, perceptions of cold resulting from exposure to water, and the time~     limitations perceived by mothers.~      Hypothesis: Mothers who are exposed to a chlorhexidine-based hand cleansing intervention will~     clean their hands (with chlorhexidine or soap and water) more frequently than mothers who are~     not exposed to the chlorhexidine-based hand cleansing program.~      Objectives:~      The primary objective~        1. To demonstrate the behavioural impact of chlorhexidine-based hand hygiene intervention~          on hand cleansing of mothers during the neonatal period The secondary objectives~        2. To demonstrate the impact of chlorhexidine-based hand hygiene intervention on hand~          cleansing of other family members, visitors to the neonate, and birth attendants during~          the neonatal period~        3. To evaluate the acceptability of chlorhexidine for hand cleansing in the neonatal period~          among mothers, other family members, and birth attendants~      Methods:~      We propose a randomized controlled trial in a rural area of Bangladesh, with an active~     control. Randomization will be at the level of the participating pregnant woman. Each arm~     will include 150 participants. All intervention visits will follow baseline data collection.~     A trained health and hygiene promoter will carry out two visits in the antenatal period and~     one postnatal visit to deliver intervention messages.~      Outcome measures:~        1. Observed hand cleansing behavior of mother with chlorhexidine or soap and water at~          critical times.~        2. Observed hand cleansing behavior of other household members and visitors to home with~          chlorhexidine or soap and water at critical times.~   "
123168|NCT01955304|"~     This study will determine the effect of food on the pharmacokinetics (PK) of a single dose of~     4mg fruquintinib in normal healthy subjects.~   "
123169|NCT01955291|"~     The aims of the study is to explore whether the rehabilitation of the upper extremity~     performed in interaction with a virtual environment could improve motor function in~     post-ischemic and post-haemorrhagic stroke subjects with hemiparesis, in comparison to the~     traditional neuromotor rehabilitation treatment.~   "
123170|NCT01955278|"~     Introduction Parastomal hernia is the most common complication related to colostomies. The~     variability of the diagnostic criteria, the fallow up time and sometimes subclinical~     dimensions, detectable only with imaging, explain disparate figures cited in the literature~     (0-58%) (1). The generally accepted rate is around 50% (2). However, several authors consider~     that actually, almost all patients present parastomal hernia in the long-term fallow up (3).~      Prophylactic prosthetic meshes could reduce the incidence of this complication, reinforcing~     since the beginning the weak peristomal area of the abdominal wall. Existing scientific~     evidence, although positive, is limited and does not allow to clarify some controversial~     issues as the type of prosthetic mesh to be used and the optimal position of the mesh in~     relation to the abdominal wall (4-8).~      The use of laparoscopic approach in colorectal surgery is increasing and also sets technical~     changes to the placement of the mesh. To date, there are some technical notes (9) and two~     published prospective, observational studies that include patients underwent laparoscopic~     surgery. In the first study intraperitoneal (10) and in the second retromuscular mesh (11) is~     used, with encouraging short-term results, but they need more scientific support.~      Study Design This is a prospective, randomized, single center, clinical study where the~     sample is represented by patients undergoing elective laparoscopy assisted colorectal~     surgery, with the creation of a permanent end colostomy. Patients who accept to participate~     and are suitable for inclusion to the study will be randomized into one of the two branches~     consecutively: Treatment A: Conventional definitive end colostomy; Treatment B: Definitive~     end colostomy reinforced by retromuscular mesh Ultrapro.~      Aims Evaluate and compare the results obtained by placing prosthetic mesh to prevent~     parastomal hernia end colostomy versus realization of end colostomy by conventional~     technique.~      Primary Objective: Compare the incidence of parastomal hernias between groups during the~     monitoring period.~      Secondary objectives: Compare the overall and specific postoperative morbidity and mortality~     between groups, compare the difference in surgical time between the conventional technique~     and the prosthetic mesh group, compare hospital stay between the groups.~   "
123171|NCT01955265|"~     Background~      A physically active lifestyle is crucial for development but a large number of youth in Hong~     Kong are sedentary and do not meet the International (World Health Organisation) and the~     local (Leisure and Cultural Services Department) recommendation for physical activity. On the~     other hand, the evidence for implementing positive youth development programme through~     physical activity and sports is elusive.~      Purpose~      This study aimed to promote physical activity and sports amongst adolescents in Hong Kong~     through a structured sports mentorship intervention. The study also aimed to investigate the~     effect of such programme in positive youth development.~      Methods~      This was a two-phased study with Phase I being the preparatory stage and Phase II being the~     implementation stage. In Phase I, questionnaire surveys and focus group interviews were~     conducted to understand the relevant perceptions and opinions amongst various stakeholders~     (e.g. teachers, parents, and students). The data collected was analysed to inform the design~     and planning of the Phase II intervention. Phase II was an experimental trial of our sports~     mentorship programme. Participating students were divided into intervention and control~     group, where the former received the sports mentorship programme and the later did not. The~     intervention was 18 weeks long providing an additional 90 minutes of active time per week for~     all students in the intervention group. Programme mentors were trained and supported in~     reference to previous evidence. Intervention effectiveness were evaluated by comparing the~     outcomes between intervention and control group.~   "
123172|NCT01955252|"~     The trial that the investigators are proposing is a pilot study to determine the effect of~     the new WHO-yaws eradication strategy in Lihir Island (population 18,000), Papua New Guinea.~     New treatment policies were developed by WHO in 2012 to replace those of the 1950s. The~     recommended practice is to offer an initial MDA with azithromycin to the entire population,~     followed by resurveys every 6 months to detect and treat remaining cases.We will use serology~     surveys, clinical surveys and ulcer aetiology studies to measure the effect of mass~     azithromycin treatment on the community burden of yaws infection.~   "
123173|NCT01955239|"~     Rationale:~      Radiation-induced parotid gland dysfunction, often leading to xerostomia is the~     most-frequently occurring side-effect with a major impact on patient-reported quality of life~     after radiotherapy for head and neck cancer (HNC). Therefore, treatments for HNC are~     currently optimized to minimize the mean dose to the parotid glands. Though this resulted in~     a significant reduction of toxicity, 30%-40% of the patients still develop sustained parotid~     gland dysfunction and xerostomia.~      However, in animal studies the investigators found that the dose to the sub-volume of the~     gland containing the parotid gland stem cells is a better predictor for dysfunction than the~     mean dose to the whole gland. Subsequently, this finding was confirmed in a retrospective~     analysis in patients. Therefore, a reduction of dose specifically in this sub-volume of the~     parotid glands of patients is expected to further reduce the risk of parotid gland~     dysfunction and xerostomia.~      Objective:~      To test the hypothesis that parotid gland stem cell sparing intensity modulated radiotherapy~     in HNC patients reduces the risk of parotid gland dysfunction and xerostomia as compared to~     conventional parotid gland sparing intensity modulated radiotherapy.~      Study design:~      Double-blind prospective randomized trial (51 patients per arm). Study population: Patients~     treated for tumours in the head-and-neck region with curative radiotherapy, with or without~     the addition of chemotherapy or cetuximab.~      Intervention: Patients randomized into the experimental arm will receive a treatment in which~     the radiation dose to the parotid gland is re-distributed to minimize dose to the sub-volume~     containing the stem cells, while keeping the same mean dose to the parotid gland as a whole.~      Main study parameters/endpoints:~      Primary endpoint is parotid gland salivary secretion. Secondary endpoints are patient- and~     physician-rated xerostomia.~   "
123174|NCT01955226|"~     The purpose of this study is to determine whether Tegaderm CHG clear dressing reduces the~     number of unscheduled central catheter dressing changes compared to standard clear Tegaderm~     IV dressing in pediatric patients between the ages of 2 months to 18 years with central~     venous access. Secondarily, we will monitor contact skin irritation and central line~     associated blood stream infections.~   "
123175|NCT01955213|"~     Methylnaltrexone for the treatment of opioid-induced constipation in the setting of~     palliative or hospice care, is significantly more effective than placebo (1). However, in~     both the randomized and the open-label phase of the multi center trial showing this favorable~     outcome, the drug produced rescue-free laxation in only about half of the patients (2). There~     may be several reasons for this result, since constipation in palliative care patients often~     has multiple simultaneously occurring causes.~      Assuming that constipation of the non-responders is still opioid-induced, one of the possible~     reasons for not responding to methylnaltrexone could be that central actions of opioids~     contribute to constipation by reducing motility of the intestines through direct actions in~     the spinal dorsal horn (2). However, as methylnaltrexone is a µ-receptor antagonist and not~     all opioids are solely µ-receptor agonists another reason may well be that successful~     laxation is determined by the receptor-profile of the specific opioid the patient is using.~      Opioids do not only influence bowel functioning, but also immune system functioning and~     angiogenesis. Methylnaltrexone possibly antagonizes these changes, therefore this study will~     also investigate the influence of methylnaltrexone on immunologic and angiogenic parameters.~   "
123176|NCT01955200|"~     The purpose of this study is to determine that for patients who received stent implantation~     but present low response to regular anti-platelet treatment, whether 1-month intensified~     anti-platelet treatment by replacing clopidogrel with ticagrelor (TCL) is superior to double~     dose clopidogrel or adding cilostazol.~   "
123177|NCT01955187|"~     In this study, investigators will evaluated the long-term efficacy and safety (two years) of~     Tacrolimus-Rituximab (RTX) therapy compared to Methylprednisolone-Cyclophosphamide (CYC)~     therapy in patients with primary Membranous Nephropathy (MN).~      PRINCIPAL OBJECTIVE To evaluate whether sequential therapy with tacrolimus leads to a greater~     increase in the proportion of primary MN patients with Complete or Partial Remission when~     compared with patients receiving standard treatment. It will be assessed 24 months after the~     beginning of treatment.~      Phase of the trial: and design: Phase III study, open label, randomized, and active~     controlled trial.~      This study will have 3 stages: screening and recruitment of patients for 18 months, treatment~     period for six months in corticosteroids plus CYC group and 9 months in Tacrolimus-RTX group,~     and finally post-treatment follow-up period until to complete 24 months of follow-up since~     initial treatment.~      This study will compare the standard therapy for primary MN patients with nephrotic range~     proteinuria (active control of steroids plus CYC) with a novel sequential therapy of~     tacrolimus and RTX, an approach of potential high efficacy, low toxicity and more acceptable~     safety profile.~   "
123178|NCT01955174|"~     This study aims to evaluate the efficacy and the safety of endoscopic injection of 100 IU of~     botulinum toxin (BTX) in the distal esophagus in patients with symptoms related to~     hypercontractile esophageal motility disorders.~   "
123179|NCT01955161|"~     To establish efficacy of idalopirdine as adjunctive therapy to donepezil for symptomatic~     treatment of patients with mild-to-moderate Alzheimer's disease (AD).~   "
123180|NCT01955148|"~     This study is designed to determine if quantitative analysis of fetal Fibronectin (fFN) can~     be used to advance prediction of spontaneous preterm birth (sPTB). This will be a prospective~     observational multi-center study with approximately 15 to 20 US sites, and approximately 1210~     subjects evaluating the clinical utility of the Rapid fFN 10Q system for preterm birth risk~     assessment. A single fFN specimen will be collected from each subject between 16 weeks, 0~     days and 21 weeks, 6 days. The primary and secondary maternal outcome measures will be~     determined based on the date of delivery and the estimated date of confinement (EDC), which~     will be evaluated in a standardized manner.~   "
123181|NCT01955135|"~     Premature infants experience more respiratory problems after surgical procedures. The~     investigators aimed to compare general anesthesia with sedation on the need for~     post-operative mechanical ventilation in infants undergoing retinopathy of prematurity~     surgery.~   "
123182|NCT01955122|"~     To compare the adenoma miss rate with the EndoRings™ vs. the adenoma miss rate with Standard~     view colonoscopy.~      To compare the polyp miss rate with the EndoRings™ vs. the polyp miss rate with Standard view~     colonoscopy.In addition, time measurements including time to cecum, time for withdrawal and~     overall procedure time will be analyzed and reported for each group.~   "
123183|NCT01955109|"~     The objectives of this open-label follow-up study for subjects who previously were randomized~     and have completed the VIPES study for the treatment of peanut allergy, are:~        -  To assess the efficacy of Viaskin Peanut after up to 36 months of treatment.~        -  To evaluate the safety of long-term treatment with Viaskin Peanut.~        -  To evaluate sustained unresponsiveness to peanut after a period of 2 months without~          treatment in subjects showing desensitization to peanut after treatment with Viaskin~          Peanut.~   "
123184|NCT01955096|"~     The purpose of this study is to to investigate the feasibility and safety of fast-track~     surgery when combined with laparoscopic-assisted gastrectomy for advanced gastric cancer~     patients.~   "
123185|NCT01955083|"~     1. Background：The methods of anti-snore (treatment of snoring ) can be divided into~          conservative, invasive and minimal invasive treatment. IN brief, minimal invasive~          surgery involving radiofrequency and pillar implant demonstrates significantly~          improvement of snoring without major complication. Previous studies usually evaluated~          snoring through subjective measures such as visual analog scale visual analog scale.~          Rare reports analyzed snore sound instrumentally and no report demonstrates the~          correlation between subjective perception and objective assessment of snoring before and~          after surgical intervention.~        2. Purposes：~             1. Development of snore sound spectrum.~             2. Exploration of the correlation between subjective perception and objective~               assessment of snoring.~             3. Comparison of changes in snoring before and after minimal invasive surgery and~               between two kinds of MIS to have a understanding of surgical impact in subjective~               and objective measurement.~        3. Method：We plan to enroll 30 subjects diagnosed by polysomnography as simple snoring or~          mild OSA with major complaint of snoring and favorable anatomic structure for minimal~          invasive surgery. All eligible subjects will be instructed the purpose, process and all~          related rights of this study and sign inform consent in outpatient clinic. Subjects~          start to complete Snore Outcome Survey (SOS, a validated questionnaire) and visual~          analog sure of snoring (VAS). Objective overnight snore sound recoding is arranged in~          sleep center. Subjects then receive minimal invasive surgery：radiofrequency or pillar~          implant of the soft palate by randomization. Both radiofrequency and pillar implant are~          common techniques in treating snoring and performed under local anesthesia as an~          outpatient procedure on sitting position. All subjects received repeated snore sound~          recording and completion of SOS and VAS three months after MIS.~        4. Outcomes~             1. Development of snore sound spectrum in sleep-disorder breathing patients.~             2. Correlation of parameters between snore sound recording (loudness, frequency,~               count, regularity, etc ) and clinical parameters.~             3. Correlation between objective (snore sound analysis) and subjective (SOS,VAS)~               assessment of snoring.~             4. Comparison of changes in snoring (particular in objective assessment) after~               radiofrequency or pillar implant.~             5. Comparison of changes in snoring between radiofrequency and pillar implant.~   "
123186|NCT01955070|"~     This is a prospective cohort study in which the standard verbal informed consent process for~     ketamine sedation is compared to a multimedia informed consent process. The goals include~     determining if parents prefer a multimedia consent process and evaluating the effectiveness~     of multimedia consent process.~   "
123189|NCT01955031|"~     Severity of diabetes is related to the development of disabling and costly complications~     (12.9 billion euros in 2007). The French High Health Authority recommends a therapeutic~     education on lifestyle and dietary rules in first-line treatment of Type 2 Diabetes Mellitus.~     Despite these recommendations, patients often have difficulties to implement dietary~     recommendations every day. The objective of EDUC@DOM is to help people with diabetes to~     improve lifestyle and equilibrium of glycaemia in order to avoid or delay chronic~     complications of diabetes. Our main goal is to assess effectiveness of our telemonitoring~     program in type 2 patients' care compared to a usual care of diabetes, on the glycaemia of~     the patients. It is expected that our program leads to a better monitoring of health status,~     a greater adherence to medical and non-medical prescriptions, an empowerment of the patient,~     and as a consequence, a more efficient health care consumption.~   "
123190|NCT01955018|"~     Asbestos fibers were intensively used throughout the 20th century and remain prevalent in~     developing countries. However, asbestos exposure induces a variety of benign and malignant~     pleural and lung diseases. The most common asbestos-induced neoplasm is lung cancer.~     Moreover, thin-section computed tomography (CT) is more sensitive than a chest x-ray for~     detecting early asbestos-related conditions. Increased exposure to radiation underpins the~     consequences of cancer induction. However, reducing CT doses increases image noise from the~     filtered back projection (FBP) reconstruction. Strategies to reduce radiation exposure~     include the use of iterative reconstruction algorithms. A new algorithm called VeoTM (General~     Electric Healthcare, Milwaukee, MI, USA) decreases the image noise up to 70% compared with~     the gold standard FBP model. Moreover, Veo improves spatial resolution with excellent~     detection of low and high contrast objects from a CT Dose Index (CTDIvol) equal to 0.3 mGy.~      The objective of the present study is to compare Veo with the gold standard FBP for detecting~     pulmonary asbestos-related conditions among workers previously exposed to asbestos.~     Comparisons included radiation delivered and image quality.~   "
123191|NCT01955005|"~     This study aims to conduct a pilot of an intervention to improve care coordination between VA~     and non-VA providers using the Department of Veteran's Affairs' (VA) personal health record,~     My HealtheVet (MHV). Participants will be randomized to receive either training on 1) how to~     use My HealtheVet to share VA health information or 2) training on how to how to search the~     Internet for health information and decide which Internet sites have good quality~     information. The investigators predict that Veterans who receive the My HealtheVet training~     will have fewer medication errors and duplication of services between the VA and outside~     providers.~   "
123192|NCT01954992|"~     The study is designed to assess whether glufosfamide provides additional survival benefit as~     compared to bolus 5-FU in patients with metastatic pancreatic cancer who have already~     progressed or failed therapy on a gemcitabine based first line regimen.~   "
123193|NCT01954979|"~     The participant is invited to take part in this study because they have chronic Graft versus~     Host Disease (cGVHD) that is not responding to standard treatment with steroids. This~     research study is a way of gaining new knowledge about the treatment of patients with cGVHD.~     This research study is evaluating a drug called abatacept.~      Abatacept is a drug that alters and suppresses the immune system. Abatacept is approved by~     the Food and Drug Administration (FDA) for the treatment of moderate to severe active~     rheumatoid arthritis in adults and of severe juvenile idiopathic arthritis (JIA) in patients~     who have failed prior therapy with disease-modifying anti-rheumatic drugs (DMARDs). These are~     autoimmune conditions, ie caused by an overactive immune system that attacks normal tissues~     and organs. It is currently being tested in a variety of other autoimmune conditions. In this~     case it is considered experimental.~      cGVHD is caused by the donor cells attacking various organs of the recipient. The~     investigators try to minimize this immune attack by using corticosteroids such as prednisone.~     In severe cases prednisone is not sufficient and other immunosuppressive medications are used~     in addition in order to more efficiently control cGVHD and to limit the dose and consequently~     the multiple side-effects of corticosteroids. This study is being done to determine if the~     use of abatacept is safe in patients with cGVHD and if it can facilitate a better control of~     cGVHD.~      During this study the participants will be evaluated for side effects from the treatment with~     abatacept, and for response of the cGVHD to the treatment. There will be two groups of~     participants in the study. The first group will be treated at a relatively low dose of~     abatacept. If this is found to be safe then the second group will be treated at a higher~     dose. Three to four tablespoons of blood will be drawn at every 2 week visit in order to~     determine your blood counts, kidney and liver function. Some of the blood will be used in a~     research lab in order to study measures of your immune system and how they might be affected~     by the treatment.~   "
123194|NCT01954966|"~     The purpose of this study is to learn whether a sex hormone called progesterone is helpful in~     reducing cigarette smoking and craving for cigarettes. This study also includes brain imaging~     to measure possible effects of progesterone on certain neurochemicals. These neurochemicals~     are called gamma-aminobutyric acid (or GABA for short) and glutamate. Both nicotine and~     progesterone affect these brain chemicals.~      Individuals wishing to participate in this study must be medically healthy men or women who~     smoke at least 10 cigarettes per day or greater. Participants must not suffer from a mental~     illness or use drugs other than nicotine and marijuana. Participants cannot have any~     implanted metallic devices such as pacemakers, orthodontic braces, or shrapnel. Participants~     must not have peanut allergies and must never have had a reaction to progesterone. Finally,~     participants cannot be taking any medications for anxiety, depression or insomnia.~   "
123195|NCT01954953|"~     This study aims to characterize Usher patients in order to correlate this data with genetic~     information.~      Tasks:~        -  Standardization and improvement of Usher syndrome diagnosis: refine and elaborate~          special tests of visual and otological function in association with genotype that enable~          to determine the most significant markers for Usher disease progression and therapeutic~          effect.~        -  Perform genotype and phenotype correlations in Usher syndrome patients~        -  Develop and maintain database for phenotypically and genotypically well-characterized~          patient cohorts, suitable for future therapeutic trials~   "
123203|NCT01954849|"~     This study investigates the efficacy of a proprietary probiotic formulation comprising 6~     strains of bacteria in reducing inflammation and gingivitis in pediatric patients between 11~     and 18 years old undergoing orthodontics treatment. Patients will be recruited based on a~     prior diagnosis of mild to moderate gingivitis by gingival index score. Participants in this~     study will be randomly assigned to receive either the probiotic treatment or a placebo, both~     in the form of a dissolving lozenge; for which the placebo is exactly the same shape,~     texture, taste, and composition as the probiotic treatment, but does not contain the active~     probiotic ingredients. The lozenges are to be taken orally at a certain prescribed regimen~     for 28 days. Participants will be assessed for gingivitis scores, gum bleeding scores, plaque~     scores, overall periodontal health, and for precarious areas at baseline, 14, and 28 days.~     They will also be assessed for the same measures at day 56, following a 28-day wash-out~     phase. Plaque and saliva samples will be collected at all timepoints for in vitro analyses of~     changes in microbial pathogens and/or inflammatory cytokines.~   "
123196|NCT01954940|"~     Whole-body vibration therapy (WBVT) is a novel, non-pharmacological intervention aimed at~     improving muscle strength and endurance as well as bone density. It holds promise for~     children with neuromuscular disorders such as Duchenne muscular dystrophy (DMD) since muscle~     weakness results not only from muscle breakdown but also physical inactivity and muscle~     disuse atrophy. Weak DMD patients may increasingly limit their physical activity due to fear~     of falling or loss of independence (e.g. difficulty rising to stand without assistance).~     Prolonging the length of time boys with DMD are ambulatory is important for delaying~     complications of this disease (lung hypoventilation, scoliosis) as well as maintaining bone~     health. We propose to conduct a pilot study of WBVT in young boys with Duchenne muscular~     dystrophy (DMD). The primary outcome will be to document safety and feasibility of WBVT in~     this patient population. The secondary outcomes will evaluate changes in muscle strength and~     endurance. Bone health will also be examined as part of routine clinical care. The study will~     include 20 ambulatory boys with DMD; patients will be randomized (1:1 allocation) into 2~     groups: WBVT treatment or no WBVT treatment (controls). Treatment groups will consist of 10~     boys undergoing daily WBVT in an 8-week, open-label trial.~   "
123197|NCT01954927|"~     This is a phase II double-blind placebo-controlled clinical trial evaluating the effect of~     gabapentin when added to standard pain management for patients with sickle cell disease~     experiencing acute pain crisis in the ambulatory care setting.~      Sickle cell pain is different for every patient. Some patients get complete relief from~     routine pain medicines, and others need more time or more doses of pain medicines before the~     pain goes away completely. It is known that humans have many types of pain, including~     something called neuropathic pain. Neuropathic pain in other conditions (such as diabetes)~     has been treated successfully with a medicine called gabapentin. The investigators in this~     study suspect that some sickle cell pain is a combination of pain types. They would like to~     see if adding gabapentin to the usual pain medicines makes pain go away faster or more~     completely.~      Primary Objective:~        -  To assess the analgesic efficacy of gabapentin vs. placebo for pain during~          vaso-occlusive crisis (VOC) in participants with sickle cell disease (SCD). A response~          to study drug will be defined by a decrease in pain score of ≥ 33% between presentation~          to the acute care setting and assessment at 3 hours post administration of study drug.~      Secondary Objective:~        -  To compare the total morphine equivalent dose (mg/kg) used to control pain during VOC~          between presentation to the acute care setting and assessment at 3 hours post~          administration of study drug in the gabapentin vs. placebo groups.~   "
123198|NCT01954914|"~     With a standard mobilization regimen using G-CSF, approximately 5% of allogeneic donors does~     not mobilize enough CD34+ cells to reach an optimal dose for transplantation and are~     therefore called poor mobilizers. A generally accepted optimum CD34+ PBSC dose for~     allogeneic transplantation is > 4.5 x 106/kg body weight of the recipient. The minimum total~     CD34+ PBSC dose certainly amounts to 2 x 106/kg body weight of the recipient.The objective of~     this trial is to assess the efficacy of a single dose of Plerixafor as salvage procedure in~     allogeneic stem cell donors with a poor CD34+ cell yield after the first day of peripheral~     blood stem cell collection.~   "
123199|NCT01954901|"~     The purpose of this proposed DoD study is to determine if hyperbaric oxygen therapy (HBOT)~     plus standard wound care is more effective than standard wound care alone in the rate of~     healing and prevention of major amputation (metatarsal and proximal) in Wagner grade 2~     diabetic lower extremity ulcers.~   "
123200|NCT01954888|"~     The first purpose of this study is to compare the effectiveness of the stellate ganglion~     block realized with two different approaches (blind and ultrasound-guided) in patients with a~     diagnosis of complex regional pain syndrome.~      The second purpose of this study is to determine the safest approach and to compare the~     safety profiles of the two approaches.~   "
123201|NCT01954875|"~     The etiology of many neurodegenerative diseases is unknown. A few studies have suggested the~     role of infection in the gastrointestinal tract in the etiology and pathogenesis of~     neurological diseases such as idiopathic Parkinson. For example, infection with Helicobacter~     pylori has been suggested to play a role in Parkinson disease. In addition, bacterial~     pathogens such as spirochetes and bacterial products such as cyanobacterial toxins have been~     speculated as the contributing factors in the development of amyotrophic lateral sclerosis~     (ALS). The effect of microbial composition of the gut in the pathogenesis of ALS is~     suspected. The difference in the bacterial profile of the gut has been documented in diseases~     such as inflammatory bowel disease and obesity.~      The goal of this IRB protocol is to create a human tissue bank and to obtain patients'~     demographic information for future investigation of the role of bacterial pathogens and the~     role of gut flora composition in the development of neurodegenerative diseases including but~     not limited to ALS, Parkinson's disease, and multiple sclerosis.~   "
123202|NCT01954862|"~     Insufflation of the colon, usually with room air, is necessary to distend the lumen for~     exploration. Carbon dioxide (CO2) insufflation instead of room air insufflation (AI) has been~     shown to decrease symptoms of abdominal pain or discomfort during the procedure and~     particularly during the following 24 hours. CO2 is is rapidly absorbed by the intestinal~     mucosa and exhaled through respiration. AI colonoscopy has usually been the reference~     standard to compare colonoscopy using CO2 insufflation. In two recent articles AI was~     compared to either CO2 insufflation and Water-aided colonoscopy (WAC), which entails infusion~     of water to facilitate insertion to the cecum.~      WAC can be categorized broadly in Water Immersion (WI) and Water Exchange (WE). In WI water~     is infused during the insertion phase of colonoscopy, with removal of infused water~     predominantly during withdrawal. Occasional use of insufflation may be allowed. WE entails~     complete exclusion of insufflation, removal of residual colonic air pockets and feces, and~     suction of infused water predominantly during insertion to minimize distention. During the~     withdrawal phase insufflation is used to distend the colonic lumen.~      In the WAC arms of the two mentioned articles the insertion method used was WI, with infusion~     of water at room temperature or at 37°C. During withdrawal, air insufflation or either air or~     CO2 insufflation were employed.~      Compared to AI, CO2 insufflation and WI (using room air insufflation or CO2 insufflation~     during withdrawal) were effective in both studies in decreasing sedation requirement, pain~     and tolerance scores, with patients' higher willingness to repeat the procedure.~      Until now no direct comparison has been made within a single study about pain score during~     colonoscopy using AI, CO2 insufflation, WI/CO2, WE/CO2, WI/AI and WE/AI.~      In this study we test the hypothesis that, compared to AI, CO2 insufflation and WAC/CO2-AI~     methods will decrease pain score during colonoscopy, with reduction of sedation requirement,~     and that WE will achieve the best result. This comparative study has also the aim to test the~     respective peculiarities of each method.~   "
123228|NCT01954524|"~     Safety and tolerability of a single dose intravenous bolus injection of Sildenafil in~     patients with moderate to severe cirrhosis and kidney disease will be determined.~   "
123229|NCT01954511|"~     The objective of this study was to investigate the effect of a manual therapy and exercise~     program, focused on the rehabilitation of cervical function, on clinical signs and mandibular~     function in subjects with TMD.~   "
123204|NCT01954836|"~     Hypothesis: Fasting before (48h) and one day after chemotherapy may protect normal cells from~     the adverse effects of chemotherapy. Design: Within a randomized controlled pilot trial 30~     female patients with gynecological cancer (ovarian and breast cancer)and 4-6 scheduled~     chemotherapies will be randomized to fast 60-72 hours during the first half of chemotherapies~     or during the second half of chemotherapies and to proceed normocaloric food intake during~     the other cycles.Sequence of fasting and normocaloric food intake will be randomized.~     Assessments of adverse effects, quality of life and laboratory values take place 24 and 7~     days after each chemotherapy. Statistical analyses compare summarized differences of fasted~     and non-fasted chemotherapy cycles.~   "
123205|NCT01954823|"~     Multiple Sclerosis (MS) is the most common chronic neurological disease affecting young~     adults, with onset usually at the age 20-40. Disease modifying therapies are available to MS,~     as well as drugs to improve patients' symptoms.~      Choosing the optimized treatment for each patient is a challenge to neurologists since~     predictive biomarkers for therapy are yet to be validated and approved. Current therapy~     decisions are based predominantly on clinical evaluation of disability and disease relapses.~     Adherence to treatment in MS is sub-optimal.~      Over the past few years a growing involvement of patients in their healthcare is noted,~     specially in chronic diseases, and Patient Reported Outcomes (PRO) are being incorporated as~     part of therapy evaluation.~      Several electronic patients diaries to track adherence to therapy, PRO and drugs side effects~     in diseases such as epilepsy are available. A mobile interactive patient diary (e-diary)~     tailored for persons with MS was developed. Users can enter data on drugs intake, drugs-side~     effects and disease symptoms and receive reminders regarding adherence to treatment.~      The aim of this study is to assess the benefits of the use of an e-diary for MS patients on~     healthcare. In order to achieve this goal, 80 MS patients will be randomized into two groups:~     a study group with access to the e-diary and a control group. After a period of one year,~     satisfaction with the e-diary will be assessed. The effect of the use of the e-diary on~     quality of life, on clinical outcomes and on adherence to therapy will be evaluated by~     comparing the two groups.~      This study will indicate the possible contribution of an e-diary for the evaluation of drugs~     safety and efficacy and of patient adherence to therapy, to be applied in clinical trials and~     towards improvement of MS patient' care.~   "
123206|NCT01954810|"~     This study has aim to describe the immune response to the second dose of Japanese~     encephalitis chimeric vaccine (JECV) in children previously vaccinated with one dose of JECV~     5 years ago.~   "
123207|NCT01954797|"~     The purpose of this observational study is to examine the effects of 4-weeks of physical~     fitness training in patients with subacute ischemic stroke on cerebral imaging and~     blood-derived biomarkers.~   "
123208|NCT01954784|"~     This phase I trial studies the side effects and best dose of lenalidomide after donor stem~     cell transplant and bortezomib in treating patients with high-risk multiple myeloma. Giving~     low doses of chemotherapy and total-body irradiation before a donor stem cell transplant~     helps stop the growth of cancer cells. It may also the patient's immune system from rejecting~     the donor's stem cells. The donated stem cells may replace the patient's immune cells and~     help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the~     transplanted cells from a donor can also make an immune response against the body's normal~     cells. Giving a bortezomib at the time of transplant may stop this from happening. Biological~     therapies, such as lenalidomide, may stimulate the immune system in different ways and stop~     cancer cells from growing. Giving lenalidomide after donor stem cell transplant may be an~     effective treatment for multiple myeloma.~   "
123209|NCT01954771|"~     Self-monitoring of blood glucose (SMBG) is a common way to assess glycemic control in~     diabetes management. Multiple times of blood glucose measurements by fingerstick in the same~     day are of tough challenge to it. The changes and variations of glucose excursion in senior~     diabetics with Coronary Artery Disease (CAD)involve a safety issue besides glycated~     hemoglobin (GHb) value. The goal of this study is to explore modified SMBG protocols for~     precisely monitoring and predicting glycemic excursion, variability in senior type 2~     diabetics with CAD.~   "
123210|NCT01954758|"~     This project seeks to demonstrate the clinical value of the personalised diagnosis of the~     endometrial factor in infertility.~   "
123211|NCT01954745|"~     This research study is evaluating a drug called cabozantinib as a possible treatment cancer~     of the bile duct. Cabozantinib is a drug that targets specific pathways inside the cells of~     the body. By blocking the c-MET and VEGFR2 pathways from sending signals, cabozantinib may~     prevent cells from multiplying. This drug has been used in other research studies and~     information from those other research studies suggests that this drug may help to stop the~     growth of bile duct cancer.~      In this research study, the investigators are looking to see how well cabozantinib works in~     slowing the growth of bile duct cancer. The investigators are also assessing the safety and~     tolerability of cabozantinib in participants with this type of cancer.~   "
123212|NCT01954732|"~     This randomized clinical trial studies metformin hydrochloride in treating patients with~     pancreatic cancer that can be removed by surgery. Metformin hydrochloride may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth.~   "
123213|NCT01954719|"~     The purpose of this prospective randomised study was to determine the effect of routine~     cervical dilatation during elective caesarean section on maternal morbidity~   "
123214|NCT01954706|"~     Hormone receptor-positive tumors are the most common breast cancers in postmenopausal women,~     and drug therapies, which block the production or effects of estrogen, are the mainstay of~     treatment in these patients. Due to their effectiveness in postmenopausal women, aromatase~     inhibitors (AIs) are the standard of care for long-term estrogen suppression in these~     patients. Estrogen deficiency, however, results in multiple side effects. Some of the most~     common side effects in women taking AIs are joint and muscle aches, which promote physical~     deconditioning. Because of the long term use of AIs in postmenopausal breast cancer patients~     and the improvements in cancer-related outcomes that are observed with their use, identifying~     methods to reduce these side effects to maintain adherence to treatment is important.~     Exercise interventions in breast cancer patients also improve quality of life and reduce~     fatigue. Understanding the role of exercise in AI side effect prevention will allow us to~     translate these findings into therapy guidelines.~   "
123215|NCT01954693|"~     This is a single centre, two-arm, individually randomised, Phase II, double- blind,~     placebo-controlled trial of RAD001 (Everolimus) versus placebo in the treatment of~     neurocognitive problems in patients with tuberous sclerosis (TSC). The IMP is a licensed~     medicine in this patient group but for a different target of effect. The current trial is a~     proof of principle study for memory and executive function outcomes.~      Following an eligibility visit, patients will be scheduled for baseline visit and~     randomization. They will then be followed up for 6 months undergoing both safety and~     neurocognitive assessments whilst taking either the placebo or study drug.~      48 patients aged 16 to 60 years with tuberous sclerosis (TSC) who have IQ > 60 and a~     significant deficit in one or more primary outcome measures will be randomly allocated in a~     ratio of 2:1 to either RAD001 (Everolimus) or Placebo.~   "
123216|NCT01954680|"~     The main aim of this study is to test a new, non-medication computer-based potential~     treatment for bipolar disorder in children and adolescents.~      In the study, children and adolescents with bipolar disorder will come to our lab at Bradley~     Hospital 2-times per week for 8-weeks to play a custom computer game designed to retrain~     the brain--to build a skill that my work has shown is impaired in children/adolescents with~     bipolar disorder.~      Before and after this 8-week trial, children will have a special magnetic resonance imaging~     (MRI) scan.~      This is a test of feasibility--meaning we want to see if the 8-week trial results in brain~     changes.~      If it does, we will conduct a second study to see if it improves how bipolar children~     function--i.e., if it helps their illness.~   "
123217|NCT01954667|"~     evaluate the impact of different anthropometric measures on clinical and endoscopic severity~     of GERD and its relation to serum leptin.~   "
123218|NCT01954654|"~     The purpose of this study is to determine whether accelerated treatment with custom-made~     compression sleeve is more effective than standard procedure in the treatment of mild and~     moderate arm lymphedema secondary to primary cancer treatment.~   "
123219|NCT01954641|"~     Purpose: African American cancer patients, as compared to their White counterparts, continue~     to initiate treatment later and remain less apt to undergo complete treatment; fueling worse~     treatment outcomes including shorter survival. The concepts of transparency and~     accountability, as mechanisms of systems change have been applied for decades by~     anti-racism organizations to civil rights and social change. Yet, the application of these~     concepts to health systems' change and unequal treatment has rarely been done. The Greensboro~     Health Disparities Collaborative and two Cancer Centers have joined together to specify~     structures built into cancer care systems that make cancer care vulnerable to institutional~     racism and investigate how they can be changed to reduce racial inequity in quality and~     completion of treatment for Stage 1-2 breast and lung cancer patients.~      Participants: White and African American patients with first diagnosis of Stage 1-2 breast~     and lung cancer, with intention to treat, and their cancer care staff at 2 cancer centers.~     The 2 cancer centers are Cone Health Cancer Center (CHCC) in Greensboro, North Carolina and~     the University of Pittsburgh Medical Center (UPMC) Hillman Comprehensive Cancer Center in~     Pittsburgh, Pennsylvania.~      Procedures (methods): Using a 5-year interrupted time-series, with an embedded randomized~     control trial (RCT) study design, we will test the effectiveness of the ACCURE intervention~     components. Having received Institutional Review Board approval for Phase 1, we completed a~     5-year, retrospective review of de-identified Electronic Medical Record data to establish a~     baseline of repeated outcome measures, convening of an expert committee to design the~     intervention, and design of the real-time, electronic breast and lung cancer registry coupled~     with dummy testing of the registry system.~      The randomized trial will compare patients who receive usual care to those who receive visits~     and calls from a trained ACCURE Navigator, who is well versed in issues specific to breast~     and lung cancer and trained to serve as a two-way communication bridge to optimize the cancer~     care system's accountability and transparency for equity in quality of care. Given~     unintended, but likely variation in implementation of the ACCURE intervention by the two~     Cancer Centers (at our two research sites), 6 elements of implementation and their potential~     effect on outcomes will be documented through a process evaluation.~   "
123220|NCT01954628|"~     The primary objective of this study is to evaluate the effect of 12 weeks of treatment with~     once daily administration of AQX-1125 compared to placebo in subjects following exacerbations~     of Chronic Obstructive Pulmonary Disease (COPD) by targeting the SHIP1 (Src Homology~     2-containing Inositol-5'-Phosphatase 1) pathway.~   "
123221|NCT01954615|"~     Study Part I is a single-ascending dose study. Healthy male subjects to be included in the~     study and randomized in 6 dose groups, Groups A-F (8 subjects per group). Of the 8 subjects~     per group, 6 subjects receive the investigational drug and 2 subjects receive matching~     placebo. Study Part II is a 3-period, crossover, single dose study. Nine healthy male~     subjects to be enrolled in one group (Group G). Each subject to receive 2 different~     formulations of the prodrug and one formulation of the active drug in a randomized sequence.~   "
123222|NCT01954602|"~     The specific goal of this study is to compare the deep biliary cannulation rate and~     complication rates associated with use of touch and no touch guide-wire biliary cannulation~     techniques.~   "
123223|NCT01954589|"~     A study of ACT-462206 to evaluate the tolerability, safety, pharmacokinetics, and~     pharmacodynamic of ascending single doses of ACT-462206, a novel dual orexin receptor~     antagonist in healthy male subjects.~   "
123224|NCT01954576|"~     This pilot phase II trial studies how well Novocure's Tumor Treating Electric Fields~     (NovoTTF) therapy works in treating patients with recurrent glioblastoma multiforme. NovoTTF~     therapy uses a low intensity electric current to kill tumor cells. NovoTTF therapy may be~     effective treatment for brain cancer.~   "
123225|NCT01954563|"~     Boost vaccinations sometimes have no effect because the body has got used to the vaccine and~     no longer reacts to it. We are therefore investigating whether vaccinating with aerosolised~     MVA85A (a candidate tuberculosis vaccine) followed by a boost MVA85A intradermal vaccination~     (or vice versa) avoids this and increases the immune response to vaccination.~   "
123226|NCT01954550|"~     This randomized controlled trial (RCT) will investigate the effects of a 6-month,~     individualized, moderate-intensity cycling intervention on cognition and hippocampal volume~     in AD with three aims:~        -  Determine the immediate effect of the cycling intervention on cognition in AD.~        -  Examine if the cycling intervention slows cognitive decline in AD from baseline to 12~          months.~        -  Assess the effect of aerobic exercise on hippocampal volume in AD over 12 months using~          MRI.~      The investigators will randomize 90 participants to the 6-month cycling or stretching/range~     of motion exercise (20-50-minute, 3 times a week). Participants will then be followed for~     another 6 months. Cognition will be assessed at baseline, 3, 6, 9, and 12 months and~     hippocampal volume will be measured using magnetic resonance imaging (MRI) at baseline, 6,~     and 12 months.~   "
123227|NCT01954537|"~     To collect field data in professional, collegiate, and high school football players to~     determine how they respond physiologically to the rigors of preseason training environment.~     Investigators will compare core temperature, hydration status, practice guidelines regarding~     rest and hydration, and baseline knowledge of heat illness and hydration among the three~     levels. The hypothesis is higher peak temperatures will be observed in the younger less~     experienced football players.~   "
123232|NCT01954472|"~     Is it possible to recruit and retain up to 200 participants in a Randomize Control Trial~     (RCT) of high impact lifestyle approach of diet and exercise designed to significantly reduce~     cardiovascular events in middle-aged and older men and women at high risk of such events? To~     address this question, we propose a pilot study of 3 years in duration: 1 year recruitment~     and randomization, a full year of intervention for all recruited participants, and the last 6~     months to assess the one year data and prepare and submit the full trial application,~     informed by the pilot study outcomes in terms of retention rate. The pilot will then continue~     on for the full 9 years of intervention and be rolled into the main study involving~     additional Canadian centers and collaborating international centers in the US, Britain,~     Europe, Australia, New Zealand, India, and South Africa.~   "
123233|NCT01954459|"~     This study will investigate the effect of wearing a small warming patch, the InsuPatch, at~     the site of the continuous glucose monitor (CGM), also called a sensor. Specifically, we will~     be looking to see if using the InsuPatch (IP) improves the accuracy of the continuous glucose~     monitor.~   "
123234|NCT01954446|"~     The primary purpose of this investigation is to validate the performance and safety of the~     Investigational Device (ID) against a validated and legally cleared device for measuring~     Blood Pressure (BP). The secondary purpose is to validate the performance of the ID over a~     period of 24 hours against a validated and legally cleared device for Ambulatory Blood~     Pressure Monitoring (ABPM).~   "
123235|NCT01954433|"~     This study compares costs and effectiveness / utility of three common orthopedic surgeries in~     shoulder and hand from the perspective of the Swiss health system and the clinic.~      The cost of health care is continuously rising, making economic considerations part of the~     decision process, in particular for the allocation of available resources. However,~     cost-effectiveness and cost-utility studies of interventions in the upper extremities are~     rare. The purpose of this study is to gain more information and to provide a basis for the~     decision process.~   "
123236|NCT01954420|"~     The purpose of the research is to test the efficacy of a patient-controlled~     cognitive-behavioral intervention for pain, fatigue, and sleep disturbance during cancer~     treatment, and to evaluate moderators and mediators of intervention effects. The intervention~     uses guided imagery, relaxation exercises, and nature sound recordings, self-administered via~     an MP3 player. The study will determine (1) if the intervention helps to control symptoms~     during chemotherapy, (2) if personal and clinical characteristics influence how well the~     intervention works, and (3) if the cognitive-behavioral strategies reduce markers of stress~     and inflammation found in blood and saliva.~   "
123237|NCT01954407|"~     The purpose of this study is to determine whether anti-smoking messages based on promising~     smoking-related beliefs increase anti-smoking intentions more than messages based on~     less-promising beliefs. Never smokers and former smokers will be randomly assigned to view~     different anti-smoking messages, and will answer questions measuring smoking-related beliefs,~     intentions, and message ratings online.~   "
123238|NCT01954394|"~     Primary Objective:~      To assess the long-term safety of alirocumab when added to lipid-lowering therapy in patients~     with heterozygous familial hypercholesterolemia (heFH).~      Secondary Objectives:~      To evaluate the long-term efficacy of alirocumab on lipid parameters. To evaluate the~     long-term immunogenicity of alirocumab.~   "
123239|NCT01954381|"~     Rheumatoid arthritis (RA) is one of the most common inflammatory diseases in the general~     population and many cardiovascular diseases (valvular, myocardial, pericardial, coronary~     disease, stroke, heart failure etc.) have already been described in this disease. Large~     epidemiological studies have also demonstrated a higher degree of severity of atherosclerotic~     vascular disease in RA patients, to such a degree that several authors have highlighted the~     fact that, in the final analysis, the prognosis of RA is rather determined by the severity of~     atherosclerotic lesions.~      By reducing RA-related systemic inflammation, it can therefore be hypothesized that 24 weeks~     of anti-TNF therapy would improve arterial endothelial function and large artery stiffness.~      The proposed study will assess the effects of adalimumab therapy on these parameters. A group~     of 26 RA patients will be recruited from a rheumatologists association of the French PACA~     region (CONCERTO association). This study will be non invasive and will comprise:~        -  in vivo study of endothelial function by measuring the post-ischaemic dilatation by 2D~          ultrasound;~        -  study of large artery stiffness by pulse wave velocity determined by aplannation~          tonometry;~        -  study of central pulse pressure;~        -  evaluation of atherosclerosis-related parameters such as intima-media thickness.~      The results obtained should provide a better understanding of the mechanisms involved in~     RA-related vascular disease and the effects of anti-TNF therapy.~      In view of the high prevalence of RA, this study could potentially interest the medical~     community as a whole and could be largely diffused.~   "
123240|NCT01954368|"~     Non-invasive and simple, intranasal (IN) route of administration seems promising for pain~     management in the Emergency Department (ED), especially when used precociously by triage~     nurse to rapidly deliver the first opioid dose to severely painful patients.~      This randomized double-blind placebo-controlled study will focus on severe traumatic pain~     experienced by adults admitted in our ED.~      We hypothesized that, in addition to traditional morphine titration, a single dose of IN~     sufentanil given at triage would significantly increase the proportion of patients relieved~     30 minutes after their ED admission.~      Time to discharge, proportion of side effects and satisfaction rates will also be recorded.~   "
123241|NCT01954355|"~     The primary aim of this trial is to establish the maximum tolerated dose (MTD) and the~     recommended phase II dose (RP2D) of LDE225 given in combination with standard doses of~     paclitaxel in patients with advanced solid tumors. In addition, the preliminary anti-tumor~     activity of this combination will be assessed, in particular in ovarian cancer.~   "
123242|NCT01954342|"~     The purpose of this study is to measure energy intake and energy expenditure during and after~     pregnancy. The investigators hypothesize that obese pregnant women with weight gain above the~     IOM guidelines, 'High Gainers', will have increased energy intake but no evidence for changes~     in energy expenditure after adjustment for the weight gained when compared to women with~     appropriate gestational weight gain, 'Normal Gainers'. Additionally, the investigators will~     measure the babies born to the pregnant women enrolled in MomEE at one time point before 10~     days of life.~   "
123244|NCT01954316|"~     This is a phase 1 study to test different doses of a new investigational drug called~     CFI-400945 to see which dose is safer in people. This study will also look at the safety of~     CFI-400945 and to study its effects on patients with advanced cancers. This drug has been~     tested in animals but not yet in people.~      CFI-400945 is an oral (taken by mouth) drug that works by blocking polo-like kinase 4 (PLK4)~     from working. PLK4 is a protein that is important in regulating cell growth and division and~     cell death. Many tumors are shown to make too much PLK4. When there is too much PLK4~     produced, it is believed to lead to uncontrolled cancer cell growth and division. Therefore,~     by blocking this protein from working, it is believed to stop tumors growing or shrink them.~   "
123245|NCT01954303|"~     Coronary artery disease (CAD) is one of the leading causes of morbidity and mortality~     worldwide. Life threatening manifestations such as acute myocardial infarction (AMI) and~     sudden cardiac death are the most important causes of death in many countries. Cardiac~     troponin is a biomarker with a high specificity for cardiac necrosis and is recommended for~     diagnosis of acute myocardial infarction by the Universal definition of myocardial~     infarction. Since a new generation of high-sensitivity cardiac troponin assays has become~     commercially available a few years ago, myocardial infarction can be detected earlier and~     even small AMIs, that were classified as unstable angina pectoris (UAP) with the less~     sensitive assays, are detectable now. On the other side, more patients with acute or chronic~     myocardial damage not due to AMI are identified now. Thereby, the reason for elevated~     troponin levels should be sought actively, because high troponin levels were associated with~     adverse outcome - independent of the underlying pathomechanism. The reasons for troponin~     elevations in patients with stable CAD are not clear yet. Associations with extensive~     atherosclerosis, carotid lesions and complex coronary plaques in coronary CT scans were~     reported. Therefore, patients with elevated troponin levels represent a risk population and~     might profit from intensified secondary prevention. In this context, ticagrelor might be part~     of a prevention strategy as currently tested in the PEGASUS trial.~      We plan to conduct a single-centre pilot study in a cohort with clinically stable patients of~     our outpatient clinic, because data regarding prevalence, causes and prognosis of elevated~     troponin values in unselected cohorts is sparse. Therefore, all patients (n=910) that~     presented to our outpatient clinic 12 months after introduction of the high-sensitivity~     troponin T assay (june 2009) and were free of complaints or presented with UAP are being~     enrolled. All patients are characterized by demographic, laboratory and clinical~     characteristics (including medication) and all available imaging data (exercise-ecg,~     echocardiography, stress-echocardiography, computed tomography, cardiac MRI and coronary~     angiography) in order to compare baseline characteristics of troponin positive and troponin~     negative patients. In addition, the Framingham- and PROCAM-Score representing established~     calculators of long-term risk prediction are calculated.~      Prognostic endpoints are defined as severe cardiovascular events and progress of the~     initially diagnosed disease. Those endpoints are associated with the initial hs-cTnT value~     and serial changes.~   "
123246|NCT01954290|"~     Stroke remains the fourth leading cause of death in the United States (second worldwide) and~     a leading cause of long-term disability, resulting in total direct and indirect costs of~     approximately $73.7 billion annually. The failure of novel therapies in clinical trials~     demonstrates that the complex neural response to stroke must be targeted at multiple levels~     to improve patient outcomes. Despite significant improvements in stroke treatment and~     management, 1 year survival rate among stroke patients aged 65 years or more is around 25%,~     and 5- year survival rate amounts to approximately 50%. The highest chances of death are~     within 30 days of stroke. Mortality increases due to worsening brain dysfunction, elevated~     intracranial pressure (ICP), and other comorbid conditions.~      Treatments aimed at reducing post-stroke cytotoxic edema may reduce the risk for development~     of malignant stroke and mortality. Current treatments such as osmo-therapy and~     hemicraniectomy have substantial limitations, and mortality remains high, despite these~     measures outcomes remain unsatisfactory. There is a great need for alternative medical~     approaches which are safe, predictable, and help to ameliorate post stroke edema.~   "
123247|NCT01954277|"~     The purpose of this study is to determine whether electroacupuncture is effective in the~     treatment of chronic tension-type headache, measured by Headache Impact Test, Visual Analogue~     Scale and biomarkers.~   "
123248|NCT01954264|"~     This study is designed to characterise P. falciparum transmission intensity in subjects aged~     ≥6 months and <10 years by measurement of P. falciparum parasite prevalence, and to estimate~     the use of malaria control interventions at some centres selected for the EPI-MAL-002 and~     EPI-MAL-003 studies in sub-Saharan Western Africa.~   "
123249|NCT01954251|"~     The purpose of this study is to assess immunogenicity, reactogenicity and safety of GSK~     Biologicals' HZ/su vaccine when its first dose is co-administered with the FLU-D-QIV vaccine~     in adults aged 50 years or older compared to administration of vaccines separately.~   "
123250|NCT01954238|"~     The purpose of this study is to evaluate the safety, tolerability and~     Pharmacokinetics/Pharmacodynamics of multiple doses of GCC-4401C in healthy male subjects.~   "
123251|NCT01954225|"~     The anal fistula is a notorious disease due to its recurrence rate. Bhagandara is varyingly~     defined as a tear, ulcer or boil at Bhaga (Perianal region) within 2 finger circumference of~     it, causing painful abscess when opened is called Bhagandara. The Sanskrit word 'Bhagandara'~     has got two components-Bhaga and Darana. Bhaga means perianal region and Darana means to~     tear. The ancient Surgeon Sushruta has advocated various types of operations in Sushruta~     Samhita. He has advocated Kshara Sutra treatment due to probability of recurrence after~     surgery. Sushruta describes many kind of kshara like Palasa, Kadali. The most remarkable is~     Udumbara( Ficus Glomerata) among them. The present treatment modality Udumbara Kshara Sutra~     has been found effective due to its action of proper drainage of pus from the fistula that~     leads to a proper healing and as adjuvant therapy by avoid recurrence in Fistula in ano.~      Hypothesis; Present treatment modality Udumber Sutra will found to be useful in tne~     management of Fistula in ano.~   "
123252|NCT01954212|"~     Stroke associated pneumonia (SAP) affects a fifth of stroke survivors annually, tripling the~     risk of death at 30 days and contributing to poorer rehabilitation outcomes, prolonged~     hospital stays and dependency at discharge. Systematic review evidence indicates that~     enhanced oral health care (OHC) has a preventative effect on the incidence of pneumonia~     amongst nursing home populations (absolute risk reductions 6.6% to 11.7%; numbers needed to~     treat 8.6 to 15.3 individuals). There are strong theoretical reasons to suggest similar~     benefits might be observed in stroke care settings but current empirical evidence is weak -~     trial quality (randomisation, blinding, sample size, reporting), intervention description and~     thus feasibility of translation into clinical practice is very poor. Following an extensive~     pre-clinical programme of work, investigators now plan the pilot phase (Phase II) of a~     stepped-wedge cluster RCT of a well-developed and defined complex OHC intervention versus~     usual OHC. Investigators aim to establish a robust web-based randomisation process, refine~     the proposed intervention (training, tools, equipment), recruitment, adherence, record~     linkage and sampling methodologies. Investigators also aim to establish the relationship~     between SAP and plaque and any diversity between sites.~   "
123253|NCT01954199|"~     This study aims to verify if patients with nerve-related leg pain benefits from neurodynamic~     treatment over two weeks.~   "
123256|NCT01954160|"~     Congestive heart failure is a common disorder in which the heart cannot pump enough blood to~     meet the needs of the rest of the body. Poor sodium handling by the kidneys is a damaging~     effect of heart failure, and it leads to symptoms of congestion such as shortness of breath~     or ankle swelling. Recent studies suggest that reducing the nerve activity to a kidney could~     reduce sodium retention and blood pressure. An improvement in the way the kidneys handle~     sodium may reduce disease progression and decrease symptoms for heart failure patients.~   "
123257|NCT01954147|"~     Umbilical cord mesenchymal stem cells (SC) transplantation was a novel therapy for diabetes~     mellitus, with less side effects and more advantages. Clinical trials had verified that good~     metabolic control would be achieved when Liraglutide (GLP-1) was added to the conventional~     therapies. The investigators hypothesized that the combined therapy of umbilical cord~     mesenchymal stem cells transplantation and Liraglutide in type 2 diabetes mellitus will aid~     the differentiation of stem cells into insulin-producing cells, improve the survival of~     differentiated cells, protect the residual beta-cells and improve insulin secreting function,~     so as to achieve a favorable glucose homeostasis.~   "
123258|NCT01954134|"~     In clinical practise patients with negative radioiodine scan with positive tyhroglobulin is~     considered as radioiodine resistant or in another words in the process of dedifferentiation.~     The aim of the present study was to search a simple blood test that could lead to early~     identification of patients with dedifferentiation. In this respect, we investigate whether~     the serum level of anti-p53 antibody has the diagnostic value in the follow-up of patients~     with high levels of thyroglobulin (tg) and negative I-131 scan.~   "
123259|NCT01954121|"~     To demonstrate the non-inferiority of Levetiracetam (1000 mg/day) versus Carbamazepine~     Immediate-Release (400 mg/day) used as monotherapy for at least 6 months in a Chinese~     population with newly or recently diagnosed Epilepsy who are experiencing Partial-Onset~     Seizures (POS).~   "
123260|NCT01954108|"~     The primary objective of this study is to compare OSTENIL® TENDON (2% hyaluronan) and~     Extracorporeal Shock Wave (ESWT) therapy in the treatment of painful Achilles tendinopathy.~   "
123261|NCT01954095|"~     The purpose of this study is to analyze how the body handles and responds to progesterone~     treatment in parous and nulliparous women at risk of pre-term birth.~   "
123262|NCT01954082|"~     This is a Phase 3, randomized, double-masked, placebo-controlled study designed to determine~     the effectiveness of myo-Inositol 5% Injection to increase the incidence of survival without~     severe Retinopathy of Prematurity (ROP) through acute/final ROP determination up to 55 weeks~     postmenstrual age (PMA) in premature infants <28 0/7 weeks' gestation.~   "
123263|NCT01954069|"~     The study seeks to test whether it is feasible and acceptable for both women and providers~     (in this context the Lady Health Visitor) to use the semi-quantitative pregnancy test (SQPT)~     as a tool for follow up after MR services. The study is planned at 11service delivery points~     (primary health clinics) in Punjab province where consenting women will be asked to take a~     baseline test at the clinic the morning they present for the MR procedure. Women will be~     asked to complete a second test at home the morning of their scheduled follow up visit and~     return to the clinic for follow-up care later that day. The results of the at home test will~     be compared to the baseline to determine the outcome of the MR. This is of particular~     importance because to-date no research has documented the accuracy of the test in detecting~     MR outcomes with misoprostol only regimens.~      We hypothesize that women and providers will find the test easy and acceptable to use thereby~     improving follow up and simplifying MR service provision. In addition, the simple pictorial~     instructions will enable most women to use the test and interpret the results correctly on~     their own.~   "
123264|NCT01954056|"~     This trial will evaluate the effects of a 7-day course of hydrocortisone therapy on~     short-term morbidity, cardiovascular function, long-term neurodevelopment, and mortality in~     critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as~     defined by a need for inotrope therapy in the first 72 hours of age.~   "
123265|NCT01954043|"~     The study is being conducted to evaluate the effect of rifampin (a strong CYP3A4 inducer) and~     rabeprazole (a pH elevating agent) on the PK of dabrafenib (a CYP3A4/CYP2C8 substrate). The~     study will be conducted in subjects with BRAF V600 mutation-positive tumors. Data collected~     from this study will be used to inform recommendations regarding use of concomitant~     medications with dabrafenib and future clinical pharmacologic evaluation of dabrafenib.~   "
123266|NCT01954030|"~     The primary objectives of the study are to determine the maximum tolerated dose (MTD) of~     Carboxyamidotriazole Orotate (CTO) when combined with standard dosing of bevacizumab among~     patients with recurrent malignant glioma (WHO grade III or IV) that have previously failed~     bevacizumab (Phase 1); to determine the activity of CTO alone in bevacizumab-failure WHO~     grade IV malignant glioma patients (Phase 2, Arm 1); to determine the activity of CTO plus~     bevacizumab in bevacizumab-failure WHO grade IV malignant glioma patients (Phase 2, Arm 2).~      This study was terminated early due to funding issues. At the time of termination, the study~     was still in Phase 1 and no MTD for the combination of CTO and bevacizumab had been~     determined for this population. Phase 2 will not proceed.~   "
123267|NCT01954017|"~     The study will be conducted in two parts. Part A will be a sequential dose escalation study~     to determine the safety and tolerability of two doses of STP206 versus control. Part B will~     evaluate safety and NEC preventive efficacy of STP206 in VLBW and ELBW neonates.~   "
123268|NCT01954004|"~     This registry is intended to evaluate the impact of genomic test results towards selecting a~     first-line therapy option for newly diagnosed localized prostate cancer patients.~   "
123278|NCT01953861|"~     To evaluate the effect of food (low and high fat breakfast vs. fasting) on the~     pharmacokinetics (what the body does to the drug) of a single dose of solifenacin and~     tamsulosin administered as combination tablet EC905. Also to evaluate the safety and~     tolerability of single doses of EC905 in young, healthy male subjects, when administered~     under fed (low and high fat) or fasting conditions.~   "
123290|NCT01953705|"~     Brain scans can help identify changes that appear to increase risk for cognitive decline and~     dementia. Some of these brain changes are thought to reflect actual damage to the small blood~     vessels that support normal brain function. This clinical trial will determine whether an~     omega 3 polyunsaturated fatty acid (PUFA) therapy can promote brain health by supporting the~     small blood vessels in the brain over 3 years in older adults at high risk for cognitive~     decline and dementia of Alzheimer's type.~   "
123269|NCT01953991|"~     Removable false teeth (called removable partial dentures (RPDs)) are commonly made for people~     with missing teeth.~      RPDs are made out of a framework and the replacement teeth/gum. The framework sits on the~     teeth and the gums and can be made out of different materials, metal or non-metal, with~     different properties. The plastic teeth and gum sit on the framework.~      A common framework material is cobalt chromium, a rigid, non-precious metal alloy. Other~     framework materials include titanium and non-metal materials such as medical grade~     polyetheretherketone (PEEK).~      A review of the literature shows that no research has been reported investigating how~     different RPD framework materials impact on a person's oral health related quality of life~     (OHQoL). The sensation that different frameworks have in the mouth can be quite varied~     between people, and it would be relevant to be able to tell patients which type of framework~     is better tolerated based on research evidence.~      We hope to conduct an un-blinded randomised crossover pilot trial investigating the~     difference in patient preference and oral health related quality of life measured by patient~     centred outcomes in a group of patients due to receive tooth supported removable partial~     dentures at the Charles Clifford Dental Hospital.~   "
123270|NCT01953978|"~     The analgesic effect of dexamethasone is not well described, but studies have shown that~     dexamethasone can be a safe part of a multimodal analgesic strategy after surgery. Our~     purpose is to investigate if dexamethasone in combination with paracetamol and ibuprofen has~     an increased analgesic effect compared to paracetamol and ibuprofen alone, on postoperative~     pain after spine surgery. Our hypothesis is that dexamethasone can reduce postoperative pain~     and reduce opioidconsumption and side effects compared to placebo.~   "
123271|NCT01953952|"~     This randomized phase II trial studies radiation therapy and cisplatin with or without~     surgery in treating patients with stage III-IV oropharyngeal cancer. Radiation therapy uses~     high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing. Giving chemotherapy with radiation therapy may kill more tumor~     cells. It is not yet known whether radiation therapy and cisplatin are more effective with or~     without surgery in treating patients with oropharyngeal cancer.~   "
123272|NCT01953939|"~     During any period of rehabilitation it is important to select meaningful tests that; measure~     what you want, are responsive to changes in the patient's condition and, easy to use in the~     clinical settings. With an amputee such tests may help make sure that rehabilitation~     programmes and the prosthesis (artificial leg) provided are tailored for the individual. New~     prosthetic technology is continually being developed and the active amputee now demands more~     from their artificial limbs. Making sure that they get the right rehabilitation programmes~     and the most appropriate prosthesis will help them perform to their best.~      Twenty lower limb amputees who have had their artificial limb for at least one year will be~     recruited into this study. They will be asked to complete 2 walking tests and 4~     questionnaires that measure different aspects of their condition from the comfort of the~     socket to their perceived ability to undertake everyday tasks. Each of the tests give a score~     or grade which represents the level of their ability, as judged by the test, at that given~     time point. The tests will be repeated on a second occasion between seven to ten days after~     the first.~      By measuring the changes in the scores on these two occasions it is hoped that indices of~     reliability can be established for these particular tests that have been shown to be most~     widely used by Health Professional involved in the rehabilitation of amputees across the UK.~     It is also hoped that the minimal detectable change (MDC) can also be calculated for these~     tests. By understanding the MDC for a test then anyone using it will be able to know whether~     any changes in scores detected are real changes due to changes in the patient's abilities or~     just down to chance.~   "
123273|NCT01953926|"~     This is an open-label, non-randomized, multicenter, multinational, Phase 2 study exploring~     the efficacy and safety of neratinib as monotherapy or in combination with other therapies in~     patients with ERBB mutation-positive or EGFR gene-amplified solid tumors.~   "
123274|NCT01953913|"~     Primary objective of the trial is to evaluate the safety of afatinib in patients with locally~     advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR (Epidermal growth~     factor receptor) mutation(s) and have never been treated with an EGFR-TKI (tyrosine kinase~     inhibitor). Secondary objective is to assess the time to symptomatic progression (as judged~     by investigator).~   "
123275|NCT01953900|"~     PLEASE NOTE - THIS STUDY IS CURRENTLY ONLY RECRUITING PARTICIPANTS WITH OSTEOSARCOMA.~      The purpose of this study is to find the largest safe dose of GD2-T cells (also called~     iC9-GD2-CAR-VZV-CTLs), and additionally to evaluate if a VZV vaccine can improve the~     expansion and persistence of infused T cells, to learn what the side effects are, and to see~     whether this therapy might help patients with advanced sarcomas. Because there is no standard~     treatment for recurrent/refractory sarcomas at this time or because the currently used~     treatments do not work fully in all cases, patients are being asked to volunteer to take part~     in a gene transfer research study using special immune cells.~      The body has different ways of fighting infection and disease. No single way seems perfect~     for fighting cancers. This research study combines two different ways of fighting cancer:~     antibodies and T cells. Antibodies are types of proteins that protect the body from~     infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special~     infection-fighting blood cells that can kill other cells, including cells infected with~     viruses and tumor cells. Both antibodies and T cells have been used to treat patients with~     cancers. They have shown promise, but have not been strong enough to cure most patients.~      Investigators have found from previous research that a new gene can be put into T cells that~     will make them recognize cancer cells and kill them. Investigators now want to see if a new~     gene can be put in these cells that will let the T cells recognize and kill sarcoma cells.~     The new gene is called a chimeric antigen receptor (CAR) and consists of an antibody called~     14g2a that recognizes GD2, a protein that is found on sarcoma cells (GD2-CAR). In addition,~     it contains parts of the CD28 and OX40 genes which can stimulate T cells to make them live~     longer.~      Investigators have found that CAR-T cells can kill some of the tumor, but they don't last~     very long in the body and so the tumor eventually comes back. T cells that recognize the~     virus that causes chicken pox, varicella zoster virus (VZV), remain in the bloodstream for~     many years especially if they are stimulated or boosted by the VZV vaccine. Investigators~     will therefore insert the GD2-CAR gene into T cells that recognize VZV. These cells are~     called iC9-GD2-CAR-VZV-specific T cells but are referred to as GD2-T cells for simplicity.~   "
123276|NCT01953887|"~     A study to assess the amount of drug in the blood of young to middle aged, healthy, male~     subjects after they received the final formulation of EC905 compared to solifenacin~     (Vesicare®) and tamsulosin OCAS (Omnic OCAS®).~      Subjects are given a single dose of the combination tablet EC905, Vesicare® and Omnic OCAS®~     in 3 separate periods.~   "
123277|NCT01953874|"~     The aim of the study is to compare the effects of MV targeted ASV in addition to optimized~     medical therapy versus optimized medical therapy alone at 6 months in patients with acute~     decompensated HF. The study will also assess changes in functional parameters, biomarkers,~     quality of life (QOL), and sleep.~   "
123279|NCT01953848|"~     Tamsulosin (sold under the name Omnic OCAS) is used for treatment of voiding complaints~     related to an enlarged prostate. Solifenacin (sold under the name Vesicare) is used for the~     treatment of patients suffering from problems related to overactive bladder, such as needing~     to go to the toilet frequently and often having a sudden urgent need to go to the toilet.~     Certain patients with an enlarged prostate have complaints that may benefit from a~     combination of tamsulosin and solifenacin. EC905 is a single tablet containing both~     tamsulosin and solifenacin. The current study aims at investigating how tamsulosin and~     solifenacin are taken up from the intestine, distributed through the body and eventually~     eliminated from the body when taken as a single EC905 tablet.~   "
123280|NCT01953835|"~     This study is a Phase I, two-part, open-label study designed to evaluate the effect of~     repeated doses of GSK2586184 on the pharmacokinetics (PK) of Simvastatin and Rosuvastatin in~     healthy volunteers (Cohort A), and to evaluate the pharmacokinetics of a new tablet~     formulation of GSK2586184 in healthy male volunteers (Cohort B). Cohort A is a single~     sequence drug interaction study in which 28 subjects (14 female and 14 male subjects) will be~     enrolled. Each subject will receive single doses of Simvastatin and Rosuvastatin on two~     occasions, once alone and once following administration of repeated doses of GSK2586184.~     Cohort B is a 3-way crossover PK study in which 9 male subjects will be randomized (3~     subjects to each treatment sequence). Each subject will receive a single dose of the standard~     formulation of GSK2586184 with food and two doses of a new formulation of GSK2586184, once~     with food and once in a fasted state, according to their treatment sequence, with a 3-day~     wash out between doses. The primary aim of the study is to investigate the effects of~     GSK2586184 on the pharmacokinetics of the 2 statins and to assess the impact of dosing with~     and without food on a new formulation of GSK2586184 tablet.~   "
123281|NCT01953822|"~     This is an observational cohort study to assess the risk of autoimmune disease(s) within 12~     months of receiving the first dose of Cervarix® in the exposed cohort and over a comparable~     period in the unexposed cohorts.~      This is an alternative study by GSK using the CPRD database in the UK to fulfil the US FDA~     safety commitment. The UK has had sufficient Cervarix® vaccination coverage during the period~     mid-September 2008 to 2011 to allow suitable data to be collected.~   "
123282|NCT01953809|"~     This study is being conducted to confirm that GSK1322322 has no negative impact on hormone~     levels and contraceptive efficacy when co-administered with a frequently prescribed oral~     contraceptive thereby to facilitate the use of GSK1322322 in women of child-bearing potential~     receiving oral contraceptive (OC) pre-infection. This study is designed to investigate~     steady-state plasma ethinyl estradiol (EE) and norethindrone (NE) pharmacokinetic (PK)~     following administration of Ortho-Novum (EE/NE) 1 tablet every 24 hours (q24h) fed with and~     without GSK1322322 1500 milligram (mg) q12h fed. Each subject will participate in the study~     for approximately 12 weeks: a 30 day screening period, 4-week run-in period, three 7 day~     treatment periods, and a 3-5 day follow-up period. The study is planned to enroll~     approximately 24 subjects (18 active/6 placebo).~   "
123283|NCT01953796|"~     The objective of our study is to evaluate the efficacy of the clomiphene stair-step protocol~     to induce ovulation in women with polycystic ovarian syndrome (PCOS) compared to traditional~     protocol.~      Methods:This was a randomized controlled clinical trial at the Fertility clinic of Al sadder~     teaching hospital at Al- Najaf city, Iraq . It included 140 women who met all of the~     inclusion criteria, they were divided into two groups; 65 patients for the stair step~     protocol and 75 patients for the traditional protocol.~   "
123284|NCT01953783|"~     This is a phase 1, 2-part, open-label study in 4 to 6 pharmacokinetic-evaluable patients with~     advanced solid tumors or lymphoma.~   "
123285|NCT01953770|"~     QUESTIONS AND OBJECTIVES OF ALL-MB-2008 STUDY~        1. Whether the early PEG-asparaginase in induction will lead to the earlier achievement of~          remission, improvement of days 8 and 15 responses leading to an earlier reconstitution~          of bone marrow and immunocompetence, decrease of severe infections and early mortality~          rate?~        2. Whether the use of PEG-asparaginase in induction will allow to avoid the anthracyclines~          in standard risk group patients and to reduce treatment myelotoxicity?~        3. Whether the administration of 9 doses of PEG-asparaginase 1,000 U/m2 instead of 18 doses~          of E.coli L-asparaginase 5,000 U/m2 in standard risk patients will improve treatment~          outcome?~        4. Whether the administrations of high dose methotrexate (2 g/m2 in 24 hours) during 1-st~          consolidation in intermediate risk patients will result in decrease of central nervous~          system relapse incidence and improvement of event-free and overall survival? Whether the~          increase of 6-mercaptopurine starting dose up to 50 mg/m2 in 1-st consolidation phase~          (instead of 25 mg/m2) will decrease in relapse risk, but would not be accompanied with~          enhanced toxicity?~        5. Is it possible to completely avoid the cranial irradiation in intermediate risk~          patients? In some subgroup of intermediate risk patients? Is it enough to control~          neuroleukemia in these patients to introduce additional TIT in the consolidation phase~          of treatment? How will change the possible late effects in these patients according to~          the third arm of randomization?~        6. Will the new risk group stratification to improve overall and event-free survival?~   "
123286|NCT01953757|"~     The purpose of this study is to assess whether, in individuals with diabetic neuropathy, a~     low-fat, vegan diet in combination with a vitamin B12 supplement improves pain, sensation and~     other subjective symptoms, more effectively than a vitamin B12 supplement with no diet~     changes. The principal measure is pain as measured by the following assessment tools:~     Michigan Neuropathy Screening Instrument, Norfolk Quality of Life Questionnaire, Neuropathy~     Impairment Score - Lower Limbs, Neuropathy Total Symptom Score, Neuropathy Pain Scale, McGill~     Pain Questionnaire and Global Impression Scale. The study duration is 20 weeks.~      This study also examines the effects of a low-fat, vegan diet on mood, using the Center for~     Epidemiologic Studies Depression Scale-Revised, and the Beck Depression Inventory.~   "
123287|NCT01953744|"~     The purpose of this study is to evaluate the therapeutic response to fluconazole in patients~     with cutaneous leishmaniasis caused by and L.(V.)guyanensis and L.(V.) braziliensis.~   "
123288|NCT01953731|"~     This study will compare the plasma pharmacokinetics of a single 125mg oral dose of~     palbociclib in the presence and absence of rifampin-mediated enzyme induction in a~     fixed-sequence two-period study.~   "
123315|NCT01953380|"~     The purpose of this study is to determine whether extended information given to patients with~     contact allergy improves knowledge, treatment efficacy and daily functioning.~   "
123291|NCT01953692|"~     The purpose of this trial is to evaluate the safety, tolerability, and efficacy of~     pembrolizumab (MK-3475, KEYTRUDA®) in hematologic malignancies. The primary study hypotheses~     are that treatment with pembrolizumab will result in a clinically meaningful improvement in~     Objective Response Rate (ORR) or Complete Remission Rate (CRR).~      With Protocol Amendment 08, enrollment in the Multiple Myeloma arm (Cohort 2) has been~     completed and no further enrollment will be allowed and enrollment in the Non-Hodgkin~     Lymphoma Diffuse Large B Cell Lymphoma arm (Cohort 5) has been discontinued and no further~     enrollment will be allowed.~   "
123292|NCT01953679|"~     To compare the pharmacodynamic effects of 2 continuous dose regimens of ulipristal acetate~     5.0 and 10.0 mg-only oral contraception, versus a 24/4 day regimen of UPA 5.0 mg.~   "
123293|NCT01953666|"~     Computers now play an important role in the lives of most individuals.Access to computers is~     crucial for people with disabilities and may improve their quality of life. The use of~     computers can facilitate mainstreaming at school, for example, and the Internet may provide a~     valuable means of communication. However, the use of computers requires a certain degree of~     motor ability. People with motor disabilities frequently experience difficulties using a~     standard keyboard and standard pointing input systems such as a mouse. Many solutions exist~     to facilitate computer access, depending on the person's specific impairments and the purpose~     for which the computer is used. The most common solution relies on the use of a virtual~     keyboard which is directly displayed on the computer screen. The selection of the desired key~     on the virtual keyboard can be handled by a large variety of input devices, from a~     microgravity mouse to single switch devices supplemented by a process of dynamic scanning of~     the keyboard.Although such assistive devices render computers accessible to people with~     disabilities, the actual inputting of text can be very slow. A method to increase text input~     speed is to display words which are predicted from the letters previously typed. Word~     prediction reduces the number of necessary key strokes by avoiding having to type the whole~     word. The effect on text input speed is, however uncertain and results in the literature are~     inconclusive. Indeed, word prediction software provide a enhancement of cognitive load which~     decrease text input speed.The reduction of cognitive load could therefore be based in part on~     the optimization settings of the software and / or achievement of a rehabilitation~     program.Our hypothesis are for people with spinal cord injury : i) optimization settings word~     prediction software and ii) a rehabilitation program could improve the text input speed.The~     investigators propose to study the influence of settings word prediction software on text~     input speed and the influence of a rehabilitation program provided by a therapist, focused on~     word prediction software to help integrate them. The aim is to increase the performance of~     people with spinal cord injury and their satisfaction.~      The first phase of this research is to select the word prediction software and configuration~     that provides the best user support.The second phase corresponds to the objective of~     evaluating the efficiency of a rehabilitation program .~   "
123294|NCT01953653|"~     This protocol explores the feasibility and acceptability of using two daily diary methods to~     analyze state-dependent variables and psychosocial health outcomes in Human Immunodeficiency~     Virus (HIV)-positive young men who have sex with men (YMSM). The study will explore the~     potential of diaries for use in feedback-based interventions.~   "
123295|NCT01953640|"~     This research trial studies gene expression in patients with prostate cancer that has spread~     to other places in the body receiving cytochrome P450 17 alpha hydroxylase/17,20 lyase~     (CYP-17) inhibition therapy. Studying samples of tissue, blood, and urine in the laboratory~     from patients receiving CYP-17 inhibition therapy may help doctors learn more about changes~     that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer. It may~     also help doctors understand how well patients respond to treatment.~   "
123296|NCT01953627|"~     Laparoscopic robotic surgery (LSM) seems to increase quality of surgery. Diffusion of LSM is~     limited by cots of the only available system today. Kymerax® is a cheaper new system of LSM.~      Aim : To evaluate feasibility of laparoscopy with Kymerax® system in different laparoscopic~     procedures in gynecology.~      Material and methods : Observational study. Inclusion criteria were : patient requiring~     laparoscopic procedure in gynecology who give informed consent. The investigators evaluate~     procedures routinely performed by laparoscopy in gynecology.~      Hypothesis : Procedures performed routinely in gynecology were feasible with Kymerax® system.~   "
123297|NCT01953614|"~     Despite the abundance of theories concerning the effects of chiropractic adjustments on brain~     function, this remains an understudies area for the profession.~      Quantitative Electroencephalography (qEEG)is a technique that allows for an in-depth analysis~     of brain function. A normative database will be used to compare before, during and after~     effects of chiropractic adjustments on brain function. This will include usage of Low~     Resolution Electromagnetic Tomography (LORETA).~      This study seeks to objectively document effects of chiropractic adjustments on brain~     function.~   "
123298|NCT01953601|"~     This study consists of two parts, Part I and Part II. The purpose of Part I of the study is~     to assess the efficacy and safety of verubecestat (MK-8931) compared with placebo~     administered for 104 weeks in the treatment of amnestic mild cognitive impairment (aMCI) due~     to Alzheimer's Disease (AD), also known as prodromal AD. Participants will be randomized to~     receive placebo, or 12 mg or 40 mg verubecestat, once daily. The primary study hypothesis for~     Part I is that at least one verubecestat dose is superior to placebo with respect to the~     change from baseline in the Clinical Dementia Rating scale-Sum of Boxes (CDR-SB) score at 104~     weeks. Participants who complete Part I of the study may choose to participate in Part II,~     which is a long term double-blind extension to assess efficacy and safety of verubecestat~     administered for up to an additional 260 weeks. In Part II, all participants will receive~     either 12 mg or 40 mg verubecestat, once daily.~   "
123299|NCT01953588|"~     The study is being conducted to determine whether neoadjuvant endocrine therapy with~     fulvestrant or the combination of anastrozole and fulvestrant, is better than anastrozole~     when given before surgery to shrink the cancer and stop it from growing. Anastrozole inhibits~     tumor growth by reducing the levels of estrogen and has been approved by the Food and Drug~     Administration (FDA) of the United States for use after surgery for postmenopausal women with~     estrogen receptor positive breast cancer. It is also considered a standard of care to give~     anastrozole for a few months before surgery to shrink the tumor. Fulvestrant inhibits tumor~     cell growth by reducing the levels of estrogen receptor in the tumor cell. It is not approved~     by the FDA for use in women with early stage breast cancer before or after surgery, but is~     approved by the FDA for patients with advanced (Stage 4) estrogen receptor positive breast~     cancer that has spread to other parts of the body.~   "
123300|NCT01953575|"~     Do patients with eosinophilic esophagitis have baseline increased esophageal mucosal~     impedance?~      And will treatment that reverses esophageal eosinophilia in patients, correct abnormalities~     in mucosal impedance?~   "
123301|NCT01953562|"~     The spontaneous breathing test (SBT) is routinely performed on all intubated patients in the~     NICU who are potential candidates for extubation from mechanical ventilatory support. For all~     parents who consent, the routine SBT will be performed on all infants. In addition to the~     routine SBT the following will occur:~        1. work of breathing indices: obtained non-invasively through respiratory inductive~          plethysmography (RIP).~        2. Performing the SBT in the prone position, in addition to the routine position (supine).~   "
123302|NCT01953549|"~     The aim of this study is to investigate whether a 4-week physical fitness training (target~     intervention) in stroke patients (subacute stage) increase the walking speed and activities~     of daily living compared with a control intervention (relaxation exercises). The target or~     control intervention is performed in addition to standard rehabilitation treatment.~   "
123303|NCT01953536|"~     The purpose of this study is to assess the efficacy and safety of vintafolide alone compared~     to vintafolide plus paclitaxel and paclitaxel alone in participants with with 100% positive~     folate receptor (FR) triple negative breast cancer (TNBC).~      The primary hypothesis of this study is the vintafolide alone and/or vintafolide + paclitaxel~     will improve progression free survival (PFS) in participants with FR (100%) TNBC compared to~     paclitaxel alone.~   "
123304|NCT01953523|"~     To evaluate for any adverse effects that may be related to the administration and reception~     of autologous adipose derived stromal vascular fraction (SVF). Secondarily, the study~     monitors the results of subjective and objective findings as it applies to the non-blinded~     deployment of autologous SVF for various inflammatory and/or degenerative conditions~     including select orthopedic, neurologic, urologic and cardio-pulmonary conditions. SVF~     deployments include intra-venous, intra-articular, and soft tissue injections.~   "
123305|NCT01953510|"~     Pneumococcus is a group of bacteria that can cause pneumonia, meningitis and other diseases.~     These bacteria normally live in the nose of humans and are spread from person to person by~     touching or sneezing. There are vaccines available to protect against infection with these~     bacteria, and pneumococcus is currently the leading vaccine-preventable cause of death in~     young children. In countries where pneumococcal vaccine (PCV) has been introduced, there has~     been a big impact on the amount of disease caused by these bacteria. However, many countries,~     especially developing countries, are yet to introduce PCV as part of their routine~     immunizations. Currently a total of four doses of PCV is recommended, and the main barrier to~     vaccine introduction is cost. This study aims to identify a vaccination schedule to make PCV~     more effective and affordable for Vietnam and other developing countries.~      This study has two distinct purposes: 1) to compare different dosage schedules of PCV and 2)~     to compare different PCV vaccines.~        1. Schedules of Synflorix (PCV10) involving a three, two or one dose PCV primary series and~          two booster options will be compared. Comparisons will be made firstly in terms of~          measures of immunity to the vaccine, and secondly in terms of the effect of vaccination~          on the carriage of bacteria in the nose.~        2. The responses to PCV10 and Prevenar-13 (PCV13) will be compared, in the schedule most~          likely to be considered for global use. Again, comparisons will be made in terms of~          measures of immunity and effect on carriage in the nose.~      Infants aged two months will be randomly assigned to one of six study groups and will provide~     up to four blood samples for analysis of the measures of immunity and five nose swabs for~     analysis of carriage of bacteria. Infants will be followed up 8-9 times until the age of 24~     months. An additional control group will be recruited at 18 months of age and also followed~     up until 24 months of age.~      The results of this study will be used to facilitate decision making, at global and national~     levels, regarding introduction of PCV.~   "
123306|NCT01953497|"~     To assess the safety, tolerability, PK and PD of URC102 in healthy subjects. To evaluate the~     food effect on PK.~   "
123307|NCT01953484|"~     In physiological conditions, spontaneous ventilation is controlled by blood carbon dioxide~     (and pH) levels. In healthy animals, extracorporeal carbon dioxide removal leads to~     hypoventilation or apnea (Kolobow et al., 1977). During acute respiratory insufficiency,~     extracorporeal carbon dioxide removal may be used to control spontaneous ventilation,~     limiting risks of lung damage and relieving dyspnea (Crotti et al., 2012). However, little is~     known about how spontaneous ventilation changes in response to changes in extracorporeal~     carbon dioxide removal during acute respiratory insufficiency, especially in humans.~      Aim of this study is to monitor changes in spontaneous ventilation in awake patients treated~     with extracorporeal gas exchange support because of acute respiratory insufficiency, in~     response to changes in extracorporeal carbon dioxide removal.~   "
123308|NCT01953471|"~     Prospective multi-center study carried out in France involving patients with allergic~     rhinitis. Study in usual care where no specific diagnostic or therapeutic procedure is~     required. The patients will be asked to fill in Questionnaires on a daily and weekly basis.~   "
123309|NCT01953458|"~     -  The cohort will integrate clinical, genetic, pharmacogenomics, environmental, biomarkers~          and behavioral data in a large number of patients and will be a leading equipment for~          crossdisciplinary and translational research on hepatitis.~        -  The cohort will be the main support for estimating the relative effects of treatments~          and for further cost-effectiveness studies on the management and treatment options in~          chronic HCV (Hepatitis C Virus)and HBV (Hepatitis B virus)infections.~   "
123310|NCT01953445|"~     This phase II trial studies the effects of paclitaxel combined with phosphoinositide 3-kinase~     (PI3K) inhibitor BKM120 in patients with stage II or III breast cancer that is described as~     estrogen receptor-positive, human epidermal growth factor 2 (HER2)-negative and endocrine~     therapy resistant. Drugs such as paclitaxel stop the growth of tumors by blocking cancer cell~     division. PI3K inhibitor BKM120 inhibits some of the enzymes needed for cell growth and may~     improve the response of endocrine resistant tumors to treatment. Giving paclitaxel and PI3K~     inhibitor BKM120 before surgery may make the tumor smaller and reduce the amount of normal~     tissue that needs to be removed.~   "
123311|NCT01953432|"~     Cocaine use disorders affect approximately 1.5 million Americans annually. Currently, there~     are no US Food and Drug Administration approved medications for treatment of cocaine~     dependence; however, both animal and human studies suggest that medications affecting the~     noradrenergic system can reduce cocaine craving and use. The investigators will study the~     effect of doxazosin, an alpha-1 adrenergic antagonist, in reducing cocaine use and anxiety~     symptoms among cocaine-dependent individuals. In addition, the investigators will identify~     genetic subpopulations of participants who preferentially respond to the medication.~   "
123312|NCT01953419|"~     This phase II trial aimed to assess the efficacy and safety of pemetrexed in patients with~     pretreated metastatic gastric cancer.~   "
123313|NCT01953406|"~     The aim of this study is to evaluate the efficacy of 5-fluorouracil + Mitomycin for the~     patients with pulmonary metastasis of hepatocellular carcinoma who had progressive disease~     with sorafenib.~   "
123314|NCT01953393|"~     Type 2 diabetes is characterized by increased insulin resistance and impaired insulin~     secretion. In addition, type 2 diabetes is associated with low grade inflammation indicated~     by increased levels of proinflammatory cytokines such as TNF-α. TNF-α has previously been~     shown to impair peripheral insulin signaling in vitro and in vivo. However, it is unclear~     whether TNF-α may also affect endogenous glucose production (EGP) during fasting and glucose~     stimulated insulin secretion (GSIS) in vivo.~      We hypothesized that low dose TNF-α would increase EGP and attenuate GSIS. Recombinant human~     TNF-α or placebo was infused in healthy, non-obese and non-diabetic young men (n=10) during a~     4-hour basal period followed by an intravenous glucose tolerance test (IVGTT).~   "
123318|NCT01953341|"~     The primary purpose of this study is to determine whether AMG 333 is safe and well tolerated~     in healthy subjects and subjects with migraines. As part of the secondary objectives, this~     study will characterize the pharmacokinetic (PK) profile of AMG 333, as well as characterize~     the effect of AMG 333 on the cold pressor test (CPT)-induced increase in blood pressure after~     single oral doses in healthy subjects and subjects with migraines~   "
123319|NCT01953328|"~     The primary objective of the study was to evaluate the effect of 12 weeks of subcutaneous~     evolocumab administered every 2 weeks and once a month, compared with placebo, on percent~     change from baseline in LDL-C when used in combination with statin therapy in adults with~     high cardiovascular risk and with hyperlipidemia or mixed dyslipidemia.~   "
123320|NCT01953315|"~     This study is designed to evaluate the safety of muscle progenitor cells (MPCs) for the~     treatment of urinary incontinence due to incompetent outlet (bladder neck/urethra).~   "
123321|NCT01953302|"~     Ventral hernias, primary and recurrent, are major surgical challenge. We aim to investigate~     efficacy of modified technique of ventral hernias repair: an open intraperitoneal mesh~     technique.~   "
123322|NCT01953289|"~     The purpose of this study is to evaluate the frequency of positive free fluid cultures in~     both perforated and non-perforated appendicitis. In addition predictors of positive free~     fluid cultures will be analyzed.~   "
123323|NCT01953276|"~     Our research will examine whether the presence or absence of serial electrocardiogram (ECG)~     changes aids in reclassifying participants' risk for major adverse cardiac events (MACE) over~     and above serial blood testing.~   "
123324|NCT01953263|"~     This study is designed to evaluate the safety of autologous muscle fiber fragments for the~     treatment of urinary incontinence due to incompetent outlet (bladder neck/urethra).~   "
123325|NCT01953250|"~     Questionnaire To assess the functional outcome in patients that underwent laparoscopic~     sigmoid and/or rectum resection.~   "
123326|NCT01953237|"~     We propose to develop and pilot test the effect of a mobile smartphone intervention,~     MedActive, on improving antipsychotic adherence among individuals with schizophrenia.~   "
123327|NCT01953224|"~     The purpose of the study is to test an intervention that uses a mobile game to encourage~     increased physical activity among adults.~   "
123328|NCT01953211|"~     The degree of suppression and subsequent activation of the hypothalamic-pituitary-ovarian~     axis during the hormone-free interval in combined oral contraceptive (COC) hormone users~     varies depending on the dose of ethinyl estradiol in the formulation. This variation in~     activation may be associated with different side effects during the hormone free interval.~     Progesterone (P) remained suppressed during all 6 COC regimens (<1.8 ng/mL), which indicates~     continuous contraceptive efficacy during the 7-day hormone free interval of all formulations~     studied.~   "
123329|NCT01953198|"~     The aim of the project High Altitude Medical Research Expedition Himlung 2013 (HiReach2013)~     is to comprehensively investigate the cerebral, cardiovascular and pulmonary adaptation and~     the reactions of the human immune system during an ascent to extreme altitudes of over 7000~     m. A total of 44 healthy and trained volunteers will be included in the study after written~     informed consent has been obtained.Baseline sea level clinical examination will be performed~     in Bern, Switzerland (BE1) at 550 m 8 to 4 weeks before departure. High altitude research~     facilities will be available at the altitudes of 5000m, 6100m and 6900m. Post-expedition~     examination will be performed within 2 to 6 weeks after the end of the expedition in Bern. In~     the context of 3 sub-projects specific measurements and examinations are performed.~      These include: cMRI before and after the climb and neurovascular doppler examination during~     the climb; blood sampling for coagulation studies, cardiac and thoracic ultrasound, stress~     tests for assessment of cardiovascular performance.~   "
123330|NCT01953185|"~     Question: Does manual diaphragm release change kinematics and respiratory function of elderly~     subjects? Design: Randomized controlled trial with concealed allocation and double-blinding.~      Participants: 17 volunteers over 60 years old randomized into two groups: 09 in the Control~     Group (CG) and 08 in the Intervention Group (IG).~      Intervention: The manual diaphragm release technique was used on the IG, in two sets of ten~     deep breaths, with a one minute interval between them. The CG underwent a sham protocol~     (light touch), with same sets and time of interval.~      Outcome measures: The groups were evaluated using spirometry, manovacuometry and~     optoelectronic plethysmography (OEP), in that order, before and immediately after the~     intervention.~   "
123331|NCT01953172|"~     The study is designed to investigate the effect of AMP886 (alpha-tocotrienol) on health~     status and quality of life measures, cognitive functioning, oxidative stress, inflammation~     markers and other symptoms effects on skin, sleep and vision in the elderly.~   "
123332|NCT01953159|"~     The purpose of this study is to collect clinical data, blood samples, and self reported~     symptoms from patients that experience unusually severe neuropathy after treatment with~     paclitaxel. This data will be used to develop predictive markers for neuropathy. Blood~     samples will be used to create induced pluripotent stem (iPS) cells and eventually artificial~     nerve cells to be used to study neuropathy in the lab.~   "
123333|NCT01953146|"~     Polycystic ovary syndrome is one of the most common causes of female infertility. The cause~     of infertility in PCOS is unknown. Factors other than anovulation, including inherited or~     induced changes in the embryo quality have been suggested. Time-lapse analysis of embryo~     development is a sensitive method of detecting reduced embryo viability. Yet, there are no~     data regarding the embryo development in PCOS assessed by time-lapse analysis.~   "
123334|NCT01953133|"~     The prevalence for human immunodeficiency virus (HIV) in South Africa is 18% among 15-49 year~     old adults and 30% among female antenatal clinic attendees (UNAIDS, 2007), indicating~     continuing need for effective HIV prevention. Further, recent studies in sub-Saharan Africa~     found 60-94% of new HIV infections are occurring within marriage or co-habiting heterosexual~     partnerships (Dunkle et al., 2008). These findings signal the need for HIV prevention~     interventions that target couples in South Africa. This study is a randomized controlled~     trial of a behavioral intervention to increase HIV testing among couples living in~     Vulindlela, South Africa.~      The proposed intervention consists of six sessions (one mixed gender group, one single gender~     group, and four couples' counseling sessions). Using a randomized controlled trial (RCT)~     design with 350 heterosexual couples, we will test the hypothesis that compared with a~     one-time mixed-gender group session, the proposed intervention will improve communication,~     intimacy and trust necessary for mutual decision-making about behaviours related to sexual~     risk behaviour and testing for HIV. Improving couples' ability and motivation to participate~     in Couples HIV Testing and Counseling (CHTC) for HIV will in turn lead to reductions in~     sexual risk behaviour. Both of these outcomes are necessary and effective strategies to~     reduce the risk of HIV transmission within primary partnerships.~      This intervention is informed by several qualitative studies conducted in Vulindlela and~     Soweto, South Africa via a K08 award from NIH, as well as other funding sources. These~     preliminary studies provided insight into the challenges couples face in participating in~     CHCT, as well as the skills they need in order to address these barriers. Our experience~     conducting both qualitative and quantitative studies with comparable populations (i.e. South~     African couples) has also informed the recruitment and retention methods in this~     intervention. The proposed study takes advantage of the infrastructure and collaborative~     relationships that the PI has developed that have enabled her to implement and conduct~     research within these communities.~      The specific aims of the project are to test the efficacy of a theory-based and culturally~     appropriate couples-based intervention on the following outcomes:~        1. Rates of testing for HIV,~        2. Sexual risk behaviour for HIV (with primary and any concurrent partners).~      In addition we will evaluate the extent to which hypothesized mediating factors (e.g.,~     relationship dynamics) explain the major outcomes and the extent to which the intervention~     affects these factors.~      Ultimately, our goal is to facilitate the outcome that members of partnerships learn their~     own and their partner's HIV status. This is a crucial step for effective behavioural risk~     reduction, yet it is a relatively uncommon occurrence for partners in Vulindlela, South~     Africa. Specifically, mutual disclosure of HIV status accomplishes two important goals.~      First, this knowledge can facilitate risk-reduction behaviour within partnerships via~     effecting positive changes (e.g., condom use) in sexual behaviour with primary and any~     concurrent partners. Second, knowledge of HIV status can increase access to treatment and~     care for HIV-positive individuals, as well as reinforce behavioural choices (e.g., limiting~     concurrent partners) to stay HIV-negative. As couples are particularly vulnerable for HIV~     infection in this context, increasing testing for HIV and reducing likelihood of behavioural~     transmission of HIV within partnerships would be a high-impact outcome with the potential to~     significantly reduce the impact of HIV in an area already severely affected by the pandemic.~   "
123335|NCT01953120|"~     This research evaluates the effectiveness of a new drug called belatacept (Nulojix) for the~     prevention of acute rejection and preservation of kidney function in transplant patients.~     Belatacept was approved in 2011 by the United States Food and Drug Administration (FDA) and~     is being marketed as Nulojix. The pharmaceutical company sponsoring this study is~     Bristol-Myers Squibb.~      Belatacept is a prescription medicine used in adults to prevent transplant rejection in~     people who have received a kidney transplant. Transplant rejection happens when the body's~     immune system senses that the new transplanted kidney is different or foreign, and attacks~     it. Belatacept is used with corticosteroids and certain other medicines to help prevent~     rejection of your new kidney.~      The purpose of the research is to understand whether the new drug, belatacept, is better than~     other anti-rejection drugs, such as cyclosporine and tacrolimus that are typically used in~     the treatment against kidney rejection in transplant patients.~   "
123336|NCT01953107|"~     The prevalence of anemia in gynecologic oncology new patients has been seen in previous~     studies to be as high as 35-59%. this population includes women with several types of~     gynecologic malignancies. Therefore, it is assumed that the origin of the anemia can be due~     to anemia of chronic disease and iron deficiency anemia. No previous studies have looked at~     the efficacy of oral iron supplementation with concurrent Vitamin C in women with newly~     diagnosed gynecologic malignancies.~      Hypothesis: In newly diagnosed gynecologic oncology patients who are surgical candidates does~     treatment with 3-6 weeks of oral ferrous fumarate 300 mg once a day improve the mean change~     in hemoglobin levels, from baseline to pre-operative, in comparison to placebo.~   "
123337|NCT01953094|"~     The purpose of this study is to determine the possibility and compliance of performing anal~     Pap smear and Human Papilloma Virus (HPV) DNA testing on women with high grade lower genital~     tract dysplasia or cervical cancer and determining the prevalence of anal dysplasia in this~     population using a high-resolution anoscopy (HRA). In addition, it is being done to~     potentially develop screening, diagnostic and treatment protocol for anal dysplasia in women~     with high-grade lower genital tract dysplasia or cervical cancer.~   "
123338|NCT01953081|"~     This study is being conducted to evaluate the safety, tolerability and early efficacy of IV~     TD 8954 compared to metoclopramide in critically ill subjects, aged 18 to 85 years, who are~     admitted to the intensive care require mechanical ventilation, and are intolerant to enteral~     feeding.~   "
123339|NCT01953068|"~     Up to 50% of patients undergoing surgical aortic valve operation suffer from some level of~     post-operative cognitive dysfunction (POCD). Frontal lobes of the brain, where executive~     functions are located, are highly susceptible to trauma caused by possible blood malperfusion~     to these areas of the brain during surgery. Conventional and established neuropsychological~     test methods are poor in distinguishing these kinds of trauma, as they are isolated,~     structured tests that do not require multitasking and processing of multiple stimuli at the~     same time.~      The phase 1 goal of this study is to employ an experimental Executive reaction time (RT) test~     to see if this method could improve objective detection of subtle brain dysfunction assumed~     to underlie persistent cognitive, somatic, and affective complaints reported by patients who~     have undergone electic aortic valve replacement (AVR) surgery. Phase 2 of the study will~     concentrate on patients undergoing transcatheter aortic valve implantation (TAVI).~   "
123340|NCT01953055|"~     Current treatment options for high risk localized prostate cancer include radical~     prostatectomy +/- postoperative radiotherapy, radical radiotherapy with androgen deprivation~     therapy. Evidence has emerged that prostate cancer has a low α/β ratio in the range of 1-3~     Gy. Even with high risk tumors, prostate cancer is hypothesized to have a greater sensitivity~     to large fraction sizes and high dose per fraction radiotherapy theoretically allows for~     biological dose escalation with fewer visits and no additional toxicity. Therefore, we hope~     to determine the toxicity, quality of life, biochemical and pathological control of SBRT for~     high risk prostate cancer incorporating ENI.~   "
123341|NCT01953042|"~     This study will examine the effect of offering information sessions to a randomized group of~     patients with OCD spectrum disorders. Psychoeducation is a component of first line treatment;~     though intended to be informative in nature, these psychoeducation services can have a~     positive effect on quality of life, sense of self-efficacy, functioning and a person's~     readiness to engage in long term treatment. However, no studies have dismantled and tested~     the independent effect of psychoeducation from standard treatment such as Cognitive~     Behavioural Therapy. This study aims to directly test the potential effect of one aspect of~     CBT that if found to be helpful, can become a distinct early intervention component of care~     so that as people await services, they can profit from the early benefits associated with~     attending these information sessions. This study therefore sets out to examine the potential~     early benefits of providing education about the illness on symptom functioning, quality of~     life and readiness to engage in more formal treatment. We will offer 4 structured information~     sessions to individuals allocated to a wait list for services related to the treatment of OCD~     and OCD Spectrum Disorders in order to directly test the benefit of adding a didactic~     structured psychoeducation program to our services. The study will be a randomized trial~     where subjects (N=50) will be randomly assigned to receive either 1) 4 educational sessions~     covering information on diagnosis, treatment, available resources and self care for OCD and~     OCD Spectrum Disorders or 2) wait list as per usual with no additional information sessions.~     The experimental design is a 2 (treatment condition) by 2 (assessment phase) repeated~     measures factorial design. It is hypothesized that subjects participating in the~     psychoeducation group compared to the wait list control group will see greater reductions in~     self-reported measures of symptom severity and improvement in other measures of quality of~     life, level of functioning, self-efficacy and readiness to engage in treatment. If this study~     can demonstrate that the addition of a short structured informative intervention of 4~     sessions can confer early benefits for those suffering with OCD and OCD spectrum disorders,~     then it provides another route by which patients can improve this condition specifically~     while waiting for consultation and the opportunity to receive a more structured,~     evidence-based treatment.~   "
123342|NCT01953029|"~     The objective of our work to determine the mechanisms of myocardial infarction in women~     without obstructive coronary artery disease.~   "
123343|NCT01953016|"~     Background:~      - People with primary immune deficiency diseases (PIDD) have weak immune systems. This makes~     it hard for their bodies to fight infection. The Immune Deficiency Foundation has a network~     to collect data about people with PIDD. It is called the United States Immunodeficiency~     Network. It will help doctors and scientists better understand these disorders. The goal is~     to get medical data for everyone with these disorders in the U.S. and Canada. Data will be~     stored in a registry. Researchers can use it to study if these disorders are increasing. They~     can also learn how the disorders are diagnosed and treated.~      Objectives:~      - To collect data on people with primary immune deficiency disorders.~      Eligibility:~      - People who have a PIDD.~      Design:~        -  Data can be added with no record of personal identity.~        -  Data can be added with identity kept separate. This data will be linked to the registry~          by a code number.~        -  Data for the registry includes:~        -  Family history~        -  Disease treatment~        -  Disease characteristics~        -  Medical history~        -  Laboratory data~   "
123382|NCT01952509|"~     This multicenter, observational study will evaluate the use and efficacy of RoActemra/Actemra~     (tocilizumab) in routine clinical practice in patients with moderate to severe rheumatoid~     arthritis. Eligible patients initiated on RoActemra/Actemra treatment in accordance with the~     local label will be followed for 6 months.~   "
123383|NCT01952496|"~     The goal of this project is to design and validate a force-measuring platform that will~     measure the magnitude and duration of the load experienced by the lower extremities of~     individuals with a neuromuscular disability who use a stationary assisted standing device to~     increase their Bone Mineral Density.~   "
123384|NCT01952483|"~     Assessing the immune activation in MS patients deficient in Vitamin D and whether Vitamin D~     supplementation reverse the immune activation~      Evaluating whether Vitamin D deficiency result in lower cognitive performance in MS patients~     and the effect of Vitamin D supplementation on reversing the cognitive impairment?~   "
123344|NCT01953003|"~     Options for the treatment of patients who have progressed after an anthracycline and a taxane~     are limited. Capecitabine currently has a role in this setting, yet as many as 80% of~     patients do not respond to this treatment and those who respond eventually develop clinical~     resistance.~      The antitumour activity of vinflunine has been demonstrated in patients with breast cancer~     after exposure to anthracycline and to taxane.~      Vinflunine plus capecitabine has been shown to be a feasible combination for patients~     previously treated with an anthracycline and a taxane. Each drug in combination can be~     administered at efficacious doses.~      This population has few therapeutic options with established clinical benefit. The~     development of a new regimen and potential new standard of care for this group is important.~        -  Primary objective:~           • to compare in patients with advanced breast cancer pretreated with anthracycline and~          taxane the efficacy of the combination of vinflunine and capecitabine with capecitabine~          alone, in terms of progression-free survival.~        -  Secondary objectives:~             -  to evaluate the response rate, the time to response and the duration of response in~               both arms~             -  to compare the disease control rate between arms~             -  to evaluate the duration of disease control in both arms~             -  to evaluate the overall survival in both arms~             -  to evaluate safety~      Methodology This multicentre, open-label, randomised, Phase III study will enrol a total of~     334 patients with advanced breast cancer who have previously been treated with an~     anthracycline and a taxane. Patients will be randomised in a 1:1 ratio to receive VFL plus~     capecitabine (Arm A) or capecitabine alone (Arm B).~   "
123345|NCT01952990|"~     The purpose of this study is to determine the pharmacokinetics and safety of a nasal spray~     containing the anesthetic drug Tetracaine in combination with Oxymetazoline in healthy~     pediatric subjects.~   "
123346|NCT01952977|"~     The purpose of this study is to test the effects of medium chain triglyceride consumption,~     relative to long chain triglycerides, on hormones involved in appetite regulation and food~     intake in overweight men. We expect medium chain triglycerides to reduce appetite and food~     intake and to do so by increasing levels of hormones known to be involved in satiety and~     reduce levels of those involved in appetite.~   "
123347|NCT01952964|"~     The present study aims to compare the differences in exit site infection between patients~     receiving spray dressing and conventional care. The outcome measures including catheter exit~     site infection rate, skin allergy, catheter damage and patient satisfaction~   "
123348|NCT01952951|"~     The current standard treatment of locally advanced rectal cancer (clinical stage II or III)~     is preoperative radiation with chemotherapy (CRT) followed by surgery. But this approach can~     be suboptimal for patients with high risk features (more deeply-seated tumor or many regional~     lymph nodes involved)that are associated with recurrence. This study test a hypothesis that~     CRT followed by chemotherapy before surgery can improve efficacy of preoperative treatment.~   "
123349|NCT01952938|"~     Randomized clinical outcome study of two rotating hinge knee prosthesis in knee surgery.~     Hypothesis: No difference in the clinical outcome for 1 year after the operation. Clinical~     follow-ups at 3, 10, 90 and 360 days after surgery. Measurement of clinical parameters~   "
123350|NCT01952925|"~     The purpose of this study is to perform renal artery denervation at the same time as atrial~     fibrillation ablation. RA denervation may reduce blood pressure, increase the chances of a~     successful atrial fibrillation ablation, and decrease the number of medications required to~     control blood pressure.~   "
123351|NCT01952912|"~     The investigators hypothesize that Plasmakinetic Enucleation of the Prostate (PkEP) might~     yield functional results comparable to OP but with lower perioperative morbidity, and have~     equivalent long-term efficacy with OP for large prostates. The first objective was to~     demonstrate the non-inferiority of PKEP compared to OP concerning Qmax at one year~     postoperatively.~      To explore the long-term efficacy, we compared the efficacy, safety, and morbidity of PkEP~     with those of OP in BPH patients with prostate glands larger than 100 g over a follow-up~     period of 6 years.~   "
123352|NCT01952899|"~     Objective: Delirium is an important and frequently occurring complication in intensive care~     patients. However, screening and treatment of delirium is not in accordance with current~     national and international guidelines. The first objective of this prospective study is to~     describe the barriers and facilitators for guideline adherence. Second, investigators will~     develop a tailored implementation strategy. Finally, investigators will describe the effects~     of the tailored implementation on the adherence of the guideline in a pilot study. Design:~     Current practices, attitudes and deviations from a national (Dutch) delirium guideline will~     be assessed in a prospective before-measurement. Barriers and facilitators will be identified~     with surveys and focus group interviews. Adherence to the guideline will be studied in a~     before-after study in 7 ICUs in the Southwest of the Netherlands. Further, the effect of a~     multifaceted implementation strategy-guided implementation will be assessed with regard to~     important clinical outcomes, such as mortality and delirium incidence. Population:~     Professionals (Physicians/intensivists, nurses' and psychiatrists) and ICU patients.~     Intervention: The delirium guideline of the Netherlands Society of Intensive Care (NVIC) is~     implemented in this study. Implementation strategies: Barriers and facilitators will be~     determined in focus group interviews (n=7) with health care professionals resulting in a~     tailored guideline implementation strategy. In the development of the strategies specific~     attention will be paid to sustaining the guideline adherence. Main outcome: 1. Current~     practices; 2. Barriers and facilitators for guideline adherence; 3. Tailored implementation~     strategy; 4. Percentage of adherence to the guideline (early screening, prevention and~     treatment of delirium); 5. Effects of implementation on outcomes (economic, mortality,~     delirium incidence). Data analysis / power: The main effects, guideline adherence, will be~     evaluated by comparing the before and after measurements. Calculating from 90% power,2-sided~     alpha=0.01, 231 patients per periods will be sufficient to test the proposed adherence of~     85%. Economic evaluation: The economic analysis will be performed from a health care~     perspective. Investigator will calculate and compare the direct medical costs of usual care~     (before) and care after implementation of the guideline. Additionally, the cost of the~     tailored guideline implementation process will be calculated. The economic analysis will be a~     cost-minimalization analysis.~   "
123365|NCT01952730|"~     This study is a Pilot clinical trial. Pilot clinical trials test the safety of an~     investigational combination of drugs. Pilot studies provide information on what effects, both~     good and bad, the Investigational agent might have on your disease. Investigational means~     that the intervention is still being studied and that research doctors are trying to find out~     more about it. It also means that the FDA has not approved the treatment for your type of~     cancer.~      The main purposes of this study are to determine:~        -  The amount of vaccine that can be made for your colorectal tumor cells~        -  If the vaccine can be given safely~        -  What the effects of the vaccine are, both good and bad~        -  How the vaccine affects your immune system~        -  Whether this vaccine might have any effect on the return of your cancer in the liver~          after surgical removal~      This study is being done because there are currently no treatments which have demonstrated to~     cure diseae which has progressed, or moved beyond the site of the primary site of disease~     (colon or rectum). These vaccinations will be given after you have completed the standard of~     care treatment as determined by your doctor.~      Laboratory research has made vaccines from cancer cells by inserting genetic material from a~     protein called granulocyte-macrophage colony stimulating factor (GM-CSF) into the cancer~     cell. Once complete, the cancer cells are able to produce large amounts of GM-CSF. The~     vaccine made form these cells has a greater anti-tumor effect than cancer cells without~     GM-CSF. The purpose of this research study is to determine the safety of an investigational~     vaccine that will be made using your own colorectal cancer cells in the manner described~     above.~      This vaccine has been used in several other research studies for treatment for other cancers~     (skin, lung, ovarian, sarcoma and leukemia.) Information from these other research studies~     suggests that this vaccine may help to reduce the risk of your colorectal cancer returning~     after you have your colorectal cancer surgery.~      Due to these results in melanoma and several other tumors we are encouraged to use this~     vaccine approach in patients with liver metastases from colorectal cancer, after the cancer~     in the liver has been removed by surgery.~   "
123353|NCT01952886|"~     The purpose of this study is to assess patient satisfaction, the efficacy and compliance of~     granisetron patch versus ondansetron pills for radiation induced nausea and vomiting in~     malignant glioma patients receiving six weeks of radiation therapy (RT) and concomitant~     temozolomide (TMZ). Use of the patch may benefit brain tumor patients by increasing~     compliance.~      All eligible adult malignant glioma subjects should receive a planned total dose of 54-60 GY~     of radiation and 75 mg/m2 of daily TMZ for a total of six weeks. Subjects will be randomized~     to receive either granisetron patch or ondansetron for three weeks. Weeks 3-6, they will~     received the other medication. The granisetron transdermal delivery system (supplied as a 52~     cm^2 patch containing 34.3 mg of granisetron - 3.1 mg/day) is applied once per week 24 hours~     before the weekly radiation and chemotherapy, while the ondansetron 8 mg oral tablet is taken~     once a day 30-60 minutes prior to each dose of chemotherapy. Subjects will fill out~     questionnaires regarding the effectiveness of the medication and their satisfaction, and~     which anti-emetic they prefer.~      Safety will be assessed throughout the six weeks of radiation by the clinical research nurse~     using the Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. All subjects who~     receive both ondansetron and Granisetron Transdermal Delivery System (GTDS) treatment will be~     included in analyses of treatment preference. However, all other efficacy and safety analyses~     will include all subjects who received ondansetron or GTDS.~   "
123354|NCT01952873|"~     It is universally accepted that high-pressure balloon inflation is required to most~     effectively deploy a coronary balloon-expandable stent. However, there is not consensus nor~     are there any guidelines regarding the method of balloon inflation, particularly the duration~     of inflation. Underexpansion and strut malapposition after stent deployment are among the~     most powerful predictors for adverse vessel outcomes. High-pressure inflation for stent~     deployment is effective to optimally expand the stent, but unlike in vitro testing in air,~     there are poorly distensible plaque elements that may not instantaneously yield to the~     balloon pressure. However, these elements may ultimately yield to prolonged inflation. Most~     clinical interventional cardiologists inflate for a relatively short period (15-30 sec). The~     investigators have noted that when balloon pressure is maintained at a certain pressure level~     it tends to decrease over time, and may require 60-180 or more seconds to maintain pressure~     stability. This finding implies that plaque elements are yielding slowly over time to the~     increased pressure, thus increasing expansion, and suggests that a prolonged inflation until~     balloon pressure stabilizes is more effective than a rapid inflation/deflation sequence to~     fully expand and appose the stent to the vessel wall. At present there is no consensus on~     stent deployment strategy. It is our hypothesis that prolonged inflation is superior to the~     more commonly used strategy of rapid inflation/deflation.~      Optimal coherence tomography (OCT), a novel technology that measures near-infrared light~     reflections and translates them into a 2D image, has an axial resolution nearly 10-times that~     of intravascular ultrasound (IVUS). Thus it is possible to examine the extent of stent~     apposition and stent expansion using this modality.~      The current randomized trial tests the hypothesis that prolonged balloon inflation until a~     stable balloon pressure is maintained is more effective than a rapid inflation/deflation~     sequence when performed to the same balloon inflation pressure.~   "
123355|NCT01952860|"~     The goal of this research study is to learn the opinion of patients and their caregiving~     about a couple-based Hatha Yoga program during treatment for cancer. Researchers also want to~     learn the effect of this program on lung function, distress, and quality of life.~   "
123356|NCT01952847|"~     The goal of this clinical research study is to learn if glutamine can help control and~     prevent sores, blisters, or inflammation in your mouth or esophagus due to your current~     treatment.~      In this study, glutamine will be compared to a placebo. A placebo is not a drug. It looks~     like the drug but is not designed to treat any disease or illness. It is designed to be~     compared with a study drug to learn if the study drug has any real effect.~   "
123357|NCT01952834|"~     The study is being performed to determine whether probiotics (GoodBelly) improves blood~     vessel function.Probiotics similar to yogurt are living micro-organisms (beneficial to its~     host) the lives in the intestine. Patients who have coronary artery disease will be enrolled~     in this study. The research results will be used to determine if the type of bacteria present~     in the intestines play a role in the pathogenesis of cardiovascular disease. Patients with~     coronary artery disease will be enrolled for up to 12 weeks. Patients will take the probiotic~     for 6 weeks. Following the 6 week period there is a washout period of 4 weeks, and an~     optional antibiotic study called vancomycin. Patients will take the vancomycin for 10 days.~     Blood vessel function will be measured by ultrasound before and after the probiotic~     supplement and vancomycin antibiotic. Blood will also be taken before and after to evaluate~     for markers of inflammation.~   "
123358|NCT01952821|"~     The purpose of this study is to establish the Six-Minute Walk Test, 10-Meter Walk Test, 30~     Second Chair Stand, Linear Analog Scale of Function, and the Modifed Brief Fatigue Inventory~     as reliable and valid outcome measurements for patients with head and neck cancer.~   "
123359|NCT01952808|"~     This project will broadly explore the efficacy of community participation in the design and~     implementation of an intervention to improve physical activity and nutrition among immigrant~     and refugee (Hispanic, Somali, Sudanese, Cambodian) families in Rochester, Minnesota~   "
123360|NCT01952795|"~     The purpose of this study is to determine the impact of diet and physical exercise program on~     pregnancy rate and live birth in obese women who undergo an IVF cycle.~   "
123361|NCT01952782|"~     The investigators are seeking healthy volunteers and volunteers with reproductive disorders~     for the study of the role of dynorphin in the reproductive system. Dynorphin is a naturally~     occurring opioid hormone that is blocked by naloxone.~      We hypothesize that naloxone, by blocking dynorphin, will stimulate production of GnRH and~     kisspeptin, 2 other naturally occurring reproductive hormones.~   "
123362|NCT01952769|"~     Diffuse pontine gliomas are incurable with currently used treatments. based on data stating~     that progressive tumors inhibit immune system, would try to enhance immune system activity~     and tumor cell killing. anti PD1 prevents one of the important mechanisms allowing the tumor~     to supress the immune system thus we hope it will allow for prolonged control of the tumors~   "
123363|NCT01952756|"~     1. The number and function of circulating endothelial progenitor cells (EPCs) are inversely~          associated with coronary risk factors and atherosclerotic diseases such as PAOD.~        2. This double-blind, randomized, placebo-controlled trial to evaluate the effects of~          cilostazol on human early EPCs and angiogenesis as well as the potential mechanisms of~          action in patients with mild-to-moderate PAOD.~   "
123364|NCT01952743|"~     We propose a pilot study to assess safety and benefit of renal artery ablation at the time of~     planned atrial fibrillation ablation.~   "
123366|NCT01952717|"~     A pivotal multi-reader multi-case (MRMC) study to compare the diagnostic performance of 3D~     Koning Breast Computed Tomography (KBCT) to that of 2D Diagnostic Mammography to support the~     Pre-market Approval (PMA) of KBCT by the US Food and Drug Administration (FDA).~   "
123367|NCT01952704|"~     Aerobic exercise holds a multitude of health benefits. Studies in mice have shown that~     aerobic exercise improves memory, and increases the volume of the hippocampus, the brain's~     primary memory center. Only two studies have been conducted in humans, one in healthy elders,~     and the other in a schizophrenia population. So far, there has never been an aerobic exercise~     trial in traumatic brain injury (TBI) to look at hippocampal volume and memory as outcomes of~     interest. The proposed project is a randomized controlled trial of aerobic exercise in~     persons with TBI. We will conduct a 12-week (36 sessions) program of aerobic exercise~     (stationary cycling), versus a control condition of non-aerobic exercise (stretching), in~     memory-impaired TBI patients to a) increase hippocampal volume and b) improve memory.~     Importantly, we also expect benefits of aerobic exercise on the level of brain function.~     Specifically, we will look at 'functional connectivity,' which refers to how efficiently~     remote regions of the brain 'talk' to each other. TBI is an ideal population to benefit from~     aerobic exercise, given the young age at which many individuals sustain TBI, which allows for~     benefits of aerobic exercise to be maximally realized in a population with sufficient~     neurofunctional reserve. The expected benefits of aerobic exercise (increased hippocampal~     volume, improved memory) from this intervention stand to have a meaningful impact on people~     with TBI, including improved health, productivity, independence, and quality of life. And,~     unlike current treatments for memory impairment (e.g., pharmacological agents, cognitive~     rehabilitation), aerobic exercise is a cost-effective, all natural, readily-available~     treatment for memory problems.~   "
123368|NCT01952691|"~     The main aim of this study was to find the initial effects of kinesiotaping on pain and joint~     alignment used in the conservative treatment of hallux valgus.~      22 female patients diagnosed with hallux valgus participated in this study. Kinesiotaping was~     implemented after the first assessment and renewed in the 3rd, 7th and 10th days. The main~     outcome measures were the pain hallux adduction angle. Kinesiotaping may be an effective~     treatment option in decreasing pain and deformity in hallux valgus deformity who are~     conservatively treated. In future studies this method might be shown in larger sample groups~     at longer periods of treatment comparing with alternative treatment approaches like exercise~     or orthotics.~   "
123369|NCT01952678|"~     The primary objective of this study is to determine if the diagnostic performance of DaTscan™~     single photon emission computed tomography (SPECT) imaging is different in non-Caucasian~     subjects compared with Caucasian subjects with movement disorders.~   "
123370|NCT01952665|"~     A Multi-Center Study Comparing the Clinical Performance of Two Silicone Hydrogel Lenses Over~     1 Month of Daily Wear~   "
123371|NCT01952652|"~     In this study, the aim is to compare the efficacy of single dose naproxen sodium and~     combination of naproxen sodium-codeine phosphate on post-operative pain in adult patients~     undergoing arthroscopic menisectomy.Pre-emptive oral naproxen-codeine may be safely and more~     advantageous than naproxen alone.~   "
123372|NCT01952639|"~     Rationale: The progressive loss of skeletal muscle mass with aging, or sarcopenia, has a~     major impact on our health care system due to increased morbidity and greater need for~     hospitalization and/or institutionalization. One way to prevent skeletal muscle loss is to~     improve dietary intake of the elderly. Both whey and casein seem to offer an anabolic~     advantage over soy protein for promoting muscle hypertrophy. As a consequence it is assumed~     that (all) plant based proteins have less potent anabolic properties when compared with~     animal based proteins. However, there is little theoretical background for such assumptions.~      Objective: To provide evidence for the efficacy of wheat protein and wheat protein~     hydrolysate when compared with milk proteins (i.e. whey and casein) as a dietary protein to~     stimulate postprandial muscle protein synthesis in vivo in healthy older humans.~      Study design: double-blind, placebo-controlled intervention study Study population: 60~     healthy non-obese (BMI 18.5-30 kg/m2) older males (age: 65-80 y) Intervention: A protein~     beverage (350 mL) containing 30 g of whey, casein, wheat protein, or wheat protein~     hydrolysate or 60 g of wheat protein hydrolysate will be consumed (n=12 per group).~      Main study parameters/endpoints: Primary study parameters include muscle protein synthesis~     rates. Secondary study parameters include whole-body protein synthesis, breakdown, oxidation,~     and net balance.~      Hypotheses: We hypothesize that ingestion of wheat protein hydrolysate results in a greater~     muscle protein synthetic response when compared with the intact wheat protein due to its~     faster digestion and absorption. Furthermore, ingestion of wheat protein hydrolysate results~     in a higher muscle protein synthetic response when compared with casein, but lower when~     compared with whey protein. Ingestion of 60 g of wheat protein hydrolysate (amount of leucine~     equal to 30 g of whey protein) will result in a similar muscle protein synthetic response~     compared to ingestion of 30 g of whey protein.~   "
123373|NCT01952626|"~     Intrathecal administration of morphine is often used for control of postoperative pain.~     However, pruritus is one of the most common side effects of intrathecal morphine . Specific~     serotonin receptor antagonists could be an effective prophylactic treatment of neuraxial~     opioid-induced pruritus. It was reported that palonosetron is more effective than ondansetron~     for prevention of postoperative nausea and vomiting. Therefore, the investigators evaluated~     the efficacy of prophylactic administration of ondansetron and palonosetron for the~     prevention of intrathecal morphine-induced pruritus.~   "
123374|NCT01952613|"~     Our proposal quantitatively analyzes gait dynamics of hemiplegic individuals in response to~     the Function Electrical Stimulation (FES) intervention and identifies the responders to the~     intervention. This study will improve our knowledge of FES intervention and help clinicians~     strategize the FES interventions more effectively based on the responders' gait~     characteristics, thus supporting the NINDS' fundamental goal of translating basic and~     clinical discoveries into better ways to prevent and treat neurological disorders.~   "
123375|NCT01952600|"~     The EPOCH-RRT study seeks to fill knowledge gaps by gaining more understanding of chronic~     kidney disease (CKD) patients' priorities; assessing the comparative benefits of hemodialysis~     (HD) versus peritoneal dialysis (PD), with respect to these priorities; and providing~     tailored information to assist patients with identifying the best dialysis modality fit for~     their own unique circumstances and perspectives.~      The outcomes most relevant to patients (patient-centered) extend beyond those traditionally~     assessed in clinical research, with the relative importance varying across patient groups. A~     tailored decision aid based on these findings can improve patient decision-making processes~     regarding choice of dialysis modality.~   "
123376|NCT01952587|"~     Short title :~      X-linked biological response to HIV sensing: the ANRS EP 53 study.~      Main outcome :~      To demonstrate that HIV-infected women carry the TLR7 c.32A>T SNP at a higher frequency than~     uninfected women, arguing in favor of a role of impaired production of IFN-alpha by pDCs in~     the risk of becoming infected by HIV-1.~      Secondary outcome :~      To directly demonstrate at a single cell level that the TLR7 c.32A>T SNP is responsible for a~     reduce production of IFN-alpha by pDCs after activation of TLR7 by HIV-1 RNA.~      Short abstract (public dissemination) :~      Male and female display some differences in how their immune system responds to pathogens.~     This could be related to hormonal or genetic factors located on the X chromosome. This~     project aims at characterizing X-linked factors that can influence the innate immune response~     to HIV-1.~   "
123385|NCT01952470|"~     Patients who have undergone lung transplantation are at an increased risk of developing chest~     infections due to long-term medication suppressing the immune response. In other chronic lung~     diseases such as cystic fibrosis (CF) and bronchiectasis, inhaled, nebulised mucolytic~     medication such as dornase alpha and isotonic saline are often used as part of the management~     of lung disease characterized by increased or retained secretions. These agents act by making~     it easier to clear airway secretions, and are currently being used on a case-by-case basis~     post lung transplantation.~      To the investigators knowledge, these agents have not been evaluated via robust scientific~     investigation when used post lung transplant, yet are widely used in routine practice.~     Patients post lung transplant must be investigated separately as they exhibit differences in~     physiology that make the clearance of sputum potentially more difficult when compared to~     other lung diseases. Lower respiratory tract infections are a leading cause of hospital~     re-admission post lung transplant. Therefore, this highlights the need for a randomized~     controlled trial. The aim of this study is to assess the efficacy of dornase alpha, compared~     to isotonic saline, in the management of lower respiratory tract infections post lung~     transplant. Investigators hypothesize that dornase alpha will be more effective than isotonic~     saline.~      The effect of a daily dose of dornase alpha and isotonic saline will be compared over a~     treatment period of 1 month. Patients admitted to hospital suffering from chest infections~     characterized by sputum production post lung transplant will be eligible for study inclusion.~     Patients will be followed up through to 3 months in total to analyze short-medium term~     lasting effect. Investigators wish to monitor physiological change within the lung~     non-invasively via lung function analysis whilst assessing patient perceived benefit via~     cough specific quality of life questionnaires. These measures will be taken at study~     inclusion and repeated after 1 month and 3 months. Day to day monitoring will be performed~     via patient symptom diaries, incorporating hospital length of stay and exacerbation rate. The~     outcomes of this study have the potential to guide clinical decision-making and highlight~     safe and efficacious therapies.~   "
123386|NCT01952457|"~     The objective of this clinical investigation is to evaluate the early and mid-term outcome~     (after 6 and 12 months) and the long-term (up to 24 months) outcome of the Zilver PTX~     paclitaxel-eluting stent (Cook) versus bypass surgery for the treatment of TASC C&D~     femoropopliteal lesions.~   "
123387|NCT01952444|"~     Evaluate the safety and tolerability of intravenous (IV) ETI-204 alone and in the presence of~     IV and oral ciprofloxacin~   "
123388|NCT01952431|"~     A comparative study to test the efficacy of a novel device - the MiniBoxPFT, in measuring TLC~     (total lung capacity) compared to TLC measured by standard body plethysmography using the ZAN~     500. The study will be conducted as a prospective two-arm, open, randomized comparative~     study.~   "
123389|NCT01952418|"~     The goal of this study is to compare the adenoma detection rate achieved while using either a~     24 video monitor or a 32 video monitor.~   "
123390|NCT01952405|"~     The purpose of this study is to test the hypothesis:~      Primary hypothesis: Participants in the dialectical behavior therapy group have greater~     reductions in the frequency and severity of suicidal and non-suicidal self-injurious~     behaviors compared to participants in the alternative treatment group.~      Secondary Hypotheses: Participants in dialectical behavior therapy group have improved~     treatment outcomes compared to participants in alternative treatment, including mental health~     service utilization, symptoms of borderline personality and depression symptoms, suicidal~     thought and hopelessness, disability, and quality of life.~   "
123391|NCT01952392|"~     Prevention of cardiovascular events by antiplatelet agents after acute coronary syndrome~   "
123392|NCT01952379|"~     Melasma is an acquired hyperpigmentary disorder that commonly affects women from Asia and~     Latin-America.There is evidence of subclinical inflammation supported by diffuse spectrometry~     and by prominent inflammatory cells in affected areas; however this infiltrate and its~     inflammatory mediators remains unexplored. Chronic inflammation induces melanogenesis and~     angiogenesis; thus, it could be linked to its recurrent nature.Therefore, the aim of this~     study is to describe the inflammatory cellular infiltrate, and the expression of main~     inflammatory and angiogenic mediators in this condition, as well as to explore its~     relationship with severity of disease.~      Using histological, histochemistry, immunohistochemistry, and quantitative real-time PCR, we~     evaluated melasma lesions from 20 healthy female patients with malar melasma without specific~     solar exposure or photoprotection measures within the previous 3 weeks and compared them to~     non lesional skin.~   "
123393|NCT01952366|"~     PRODE is a Norwegian multicentre study investigating the prognosis of depression in the~     elderly. The study has included 169 patients who will be followed with assessments after one~     and three years.~      The study hypothesis is that elderly patients referred to specialist health service have a~     poor long term prognosis.~   "
123394|NCT01952353|"~     Whether preoperative transarterial chemoembolization can prolong survival for the resectable~     hepatocellular carcinoma remains controversial, particularly in patients with portal vein~     tumor thrombi. This study designs to systematically identify and summarize the effect of~     preoperative TACE for resectable HCC with portal venous invasion.~   "
123395|NCT01952340|"~     The World Health Organization has deemed high blood pressure as a global crisis because it is~     the number one risk factor associated with most deaths worldwide. Therefore, the need for~     effective and desirable treatment options is vitally necessary. The purpose of the current~     investigation is to determine the efficacy of a new therapeutic strategy: flaxseed. The aim~     is to determine the efficacy of consuming milled flaxseed every day for 6 months on the~     reduction of blood pressure in individuals newly diagnosed with high blood pressure yet to~     receive any blood pressure lowering medications. Secondary objectives are to understand how~     flaxseed at the molecular level can reduce blood pressure. The study hypothesis is that the~     flaxseed group will exhibit significant reductions in blood pressure and therefore not~     require any blood pressure lowering medication. The aim is to provide knowledge on a new~     therapeutic strategy to help manage high blood pressure.~   "
123396|NCT01952327|"~     This is a research study examining the safety of a new, automated pump for the drainage of~     fluid in the chest cavity which is caused by cancer (also known as malignant pleural~     effusion, or MPE). The purpose of the trial is to assess whether the new pleurapump device is~     safe and effective in the management of patients with MPE. The study will try to identify~     what kind of problems may arise from using the device, how often they happen, and how severe~     they are if they occur.~   "
123397|NCT01952314|"~     This study is to investigate whether naftopidil is effective or not for the spontaneous~     passage of ureteral stones with sizes of 3 to 10 mm.~   "
123398|NCT01952301|"~     A split-mouth study comparing soft tissue augmentation results using free gingival graft~     (FGG) versus xenogeneic collagen matrix (CM) for the generation of keratinized tissue (KT)~     around teeth with insufficient (< 2mm) KT.~   "
123399|NCT01952288|"~     Study of simvastatin in Iraq/Afghanistan Veterans with multiple blast exposure and mTBI. The~     study will measure substances in cerebrospinal fluid (CSF) that are related to dementing~     disorders.~   "
123400|NCT01952275|"~     This study investigates the genetic architecture of Neutrophil-Mediated Inflammatory Skin~     Diseases. After collecting informed consent, all patients' clinical phenotype is graded at~     inclusion with a detailed case report form and a discovery cohort formed based on the~     certainty of diagnosis. The DNA of patients in the discovery cohort is analyzed by whole~     exome sequencing which identifies all protein-coding genetic variants. Subsequently,~     statistical burden tests are going to identify enrichment of rare coding genetic variants in~     patients affected by Neutrophil-Mediated Inflammatory Skin Diseases.~      The ultimate goal is to reveal the responsible gene(s) that may then be targets for clinical~     intervention.~   "
123401|NCT01952262|"~     Diaphragmatic dysfunction is an important complication of mechanical ventilation. Critically~     ill patients admitted in a teaching hospital intensive care unit will be evaluated with~     diaphragm ultrasound to investigate predictors of diaphragmatic dysfunction and the clinical~     course of these patients.~      Vascular surgery patients (aortic abdominal surgery) might also be included and assessed with~     diaphragm ultrasound before and after surgery irrespectively of the need of intensive care~     unit. On December 2014 the Etical committee approved an amendment to include the possibility~     to study elective aortic abdominal surgery patient to assess the relationship between surgery~     related diaphragmatic dysfunction and postoperative respiratory complications.~   "
123402|NCT01952249|"~     This is a Phase 1b/2 study of paclitaxel plus demcizumab in subjects with platinum resistant~     ovarian, primary peritoneal or fallopian tube cancer.~   "
123403|NCT01952236|"~     This study seeks to develop and then perform a controlled efficacy Randomized Controlled~     Trial assessing tobacco abstinence of a best-practices Web-based smoking cessation~     intervention combined with a Mobile intervention. Study participants are randomized to one of~     two conditions: a Web Only intervention and the Web+Mobile intervention. The hypothesis is~     that the Web+Mobile approach will yield greater efficacy than the Web Only condition.~   "
123404|NCT01952223|"~     The objective of this study is to assess the effect of neoadjuvant cabazitaxel and pelvic~     radiotherapy in combination with ADT-radiotherapy on clinical progression-free survival in~     patients with high-risk localized prostate cancer (with a stringent selection of patients~     with at least 2 high-risk features), in a 2 by 2 factorial trial.~   "
123405|NCT01952210|"~     In this randomized pilot study, a nutritional consultation combining exercise program is~     planned for 25 locally advanced esophageal cancer patients undergoing neoadjuvant~     chemoradiation. The purpose of this study is to determine the effects of nutritional and~     exercise intervention in locally advanced esophageal cancer patients undergoing neoadjuvant~     chemoradiation.~   "
123406|NCT01952197|"~     1. Hypothesis The early elevation of the lower extremities during out-of-hospital~     cardiopulmonary resuscitation increases survival to one month by improving cardiac preload~     and blood flow to the heart and brain during chest compression.~   "
123407|NCT01952184|"~     The survival rate (and embryo quality) of donor oocytes with two commercially available~     devices.~   "
123408|NCT01952171|"~     Recent advances in genomic techniques are making possible a new wave of genetic discovery in~     congenital heart disease (CHD). Existing data suggests that CHD occur in Sub-Saharan Africa~     at frequencies similar to the rest of the world. In this application, we propose to utilize~     the unique advantages of Sub-Saharan Africa - a combination of the most genetically diverse~     populations in the world and of diminished environmental background effects (i.e. low~     prevalence of smoking, alcohol abuse, obesity in comparison to western countries) - to better~     understand the genetic basis for congenital heart disease. We will couple next generation~     genomic techniques with more traditional gene discovery methods to investigate CHD in two~     African countries: Uganda and Nigeria. The inclusion of syndromic and non-syndromic CHD~     observed in these populations as well as careful phenotyping (including echocardiography)~     will greatly enhance our potential to provide insight into the genetic architecture of CHD in~     African populations. To accomplish this, we plan to enroll families, in whom members have~     congenital heart malformations consistent with an error of early human development in our~     research protocol. Patients will be enrolled at the Uganda Heart Institute in Kampala,~     Uganda, and at the Department of Pediatrics, College of Medicine, University of Lagos,~     Nigeria, with the potential to include other African sites. High throughput genomic studies~     will be done at the NIH.~   "
123409|NCT01952158|"~     Acquisition and transmission of MDROs in healthcare facilities is a major patient safety~     problem, afflicting in particular the antibiotic-exposed and immunodeficient patient~     populations. MDRO-colonized patients require isolation to reduce the risk of transmission to~     other patients, and frequently develop infections from their colonizing organisms.~      Most clinically relevant MDROs are carried in the gastrointestinal tract; thus perirectal~     cultures are frequently the surveillance method used to screen for these pathogens.~     Surveillance to identify MDRO colonization allows for anticipation and timely initiation of~     effective treatment of patients who develop infection.~      The precise modes of transmission within hospitals are not known, but contamination of the~     hands of healthcare personnel, patient care equipment, and the healthcare environment are~     thought to play major roles in transmitting MDRO. Suboptimal hand hygiene can lead to~     transmission on the hands of staff to other patients or colonization of their own~     gastrointestinal tract. Few studies have investigated intestinal colonization of healthcare~     professionals. Transmission of bacteria by healthcare personnel is thought to occur primarily~     via contaminated hands; we wonder whether gastrointestinal carriage by healthcare personnel~     also plays a role in nosocomial spread.~      This study will screen a self-referred convenience sample of 400 healthcare personnel who~     have contact with patients or patient culture specimens for fecal carriage of MDRO at one~     point in time. A control group of 400 NIH employees or contractors who do not have contact~     with patients or patient specimens will also be screened. Samples will be linked to~     questionnaires to assess the exposure of staff members to patients or culture specimens with~     known MDRO colonization or infection. We will use molecular typing techniques to link~     healthcare personnel isolates to patient or environmental isolates. Finally, the study will~     be conducted in such a way as to preserve to the greatest extent possible the anonymity of~     volunteers, using a system of alphanumeric identifiers and unmanned drop boxes for specimen~     collection.~   "
123410|NCT01952145|"~     This trial is conducted globally. The aim of the trial is to compare the efficacy and safety~     of insulin degludec/liraglutide versus insulin glargine in subjects with type 2 diabetes~     mellitus.~   "
123411|NCT01952132|"~     The purpose of this study is to determine the safety, tolerability and pharmacokinetics of~     OMS643762 (the study drug) in psychiatrically stable schizophrenia patients.~   "
123412|NCT01952119|"~     This study will assess whether adding a secure message reminder to routine care improves the~     percentage of patients who complete a follow-up appointment with a new, documented blood~     pressure reading.~   "
123413|NCT01952106|"~     The main purpose of this study is Investigating the effectiveness of distraction by~     evaluating the children's perception of pain during venepuncture.~   "
123414|NCT01952093|"~     Despite the remarkable achievements in neonatal survival of preterm infants with very low~     birth weight (VLBW, birth weight < 1,500 g) over the past three decades, improvements have~     produced little change in their prevalence of severe developmental disability and the rate of~     low severity dysfunctions (e.g., learning disabilities, low IQ, attention-deficit~     hyperactivity disorder, specific neuropsychological deficits, poor perceptual-motor skills~     and internalizing behavioral problems) remains high as 50% to 70%. Few intervention programs~     developed for preterm infants in Western societies were shown to have short- to long-term~     benefits in certain cognitive functions, however rare studies have investigated intervention~     effect at school age and explored plausible neurological pathway for effective intervention.~     This three-year study is therefore aimed to extend our previous research to longitudinally~     examine the effectiveness of three intervention programs (clinic-based intervention program~     [CBIP], home-based intervention program [HBIP] and usual care program [UCP]) for VLBW preterm~     children in Taiwan at seven years of age.(The intervention had been delivered from birth to~     one year of corrected age in the previous study. Intervention will not be given in this~     study.)The CBIP and HBIP contained similar child- and parent-focused services as well as~     interaction activities but were respectively delivered at clinic for the CBIP and at home for~     the HBIP. A total of 178 VLBW preterm infants have been randomly assigned to the CBIP, HBIP~     or UCP. Sixty-two gender and maternal education level matched term children with normal birth~     weight have also been included to serve as the reference group for comparison of~     developmental outcomes. Effectiveness examined will include child and parent outcomes. The~     long-term effect of early intervention for preterm children will provide important~     information to help medical professionals and public policy makers to develop effective~     intervention for Taiwanese preterm children who are at risk of developmental disorders.~   "
123415|NCT01952080|"~     This will be an open label, 4-cohort study. Non-randomized subjects will receive teduglutide~     in each of the 3 active cohorts. An attempt will be made to enroll additional subjects into~     an observational cohort who will receive standard of care. Three doses of teduglutide are to~     be investigated for 12 weeks. All subjects will be screened prior to the start of treatment~     (SOT) to establish baseline characteristics including safety, eligibility and nutritional~     support parameters.~   "
123416|NCT01952067|"~     The primary aim of the study is to compare migration of the cemented Corail stem representing~     polished surfaced versions of the femoral stem. Two different methods will be used for~     reaming the femoral canal and cementing of the stem. Radiostereometric analysis (RSA) will be~     used in migration measurements.~      Furthermore pain, postoperative outcome and patient satisfaction will be assessed.~   "
123417|NCT01952054|"~     The goal of this clinical research study is to learn if denosumab in combination with a~     hormonal drug can help lower the number of circulating tumor cells (CTCs) in patients with~     breast cancer that has spread to the bone. The safety of this combination will also be~     studied.~      This is an investigational study. Denosumab is FDA approved and commercially available to~     prevent bone-related events caused by breast cancer that has spread to the bone. Using~     denosumab to lower CTCs in patients with breast cancer that has spread to the bone is~     investigational.~      You may have the option of continuing denosumab after the study ends.~      Up to 35 patients will take part in this study. All will be enrolled at MD Anderson.~   "
123418|NCT01952041|"~     The study is a three year research project whose aims are to design and test a~     state-of-the-science smartphone Ecological Momentary Assessment (EMA) and sensor technologies~     to provide mobile monitoring of schizophrenia to detect early signs of relapse. The proposed~     system will be used to continuously capture multidimensional behavior as it occurs in~     real-time and in real-world environments, detect individual early warning signs, and trigger~     targeted interventions that may mitigate the severity of relapses or prevent their recurrence~     altogether. Mobile sensors include paralinguistic aspects of speech, physical activity and~     location, and sleep. The first hypothesis is that mobile sensing and EMA techniques will~     capture early behavioral warning signs. The second hypothesis is that machine learning,~     coupled with user input, will enable development of individualized predictive risk~     signature models. The third hypothesis is that automated system patient and provider~     functions will help prevent psychotic relapses.~   "
123419|NCT01952028|"~     Laminin alpha-2 (LAMA2)-related muscular dystrophy (LAMA2-MD, Merosin Deficient CMD) is a~     form of congenital muscular dystrophy (CMD). A person with LAMA2-MD will have changes on~     brain imaging (MRI), a decrease or absence of the protein merosin (laminin 211) on muscle or~     skin biopsy and changes in the LAMA2 gene that are inherited from both parents. Several~     studies have described the changes on brain MRI. Brain changes on MRI do not correlate with~     the partial reduction or absence of merosin on muscle or skin biopsy. 8-30% of people with~     LAMA2-MD develop seizures. The types of seizures, electroencephalogram changes and common~     treatment regimens have not been characterized. This study will review the magnetic resonance~     imaging (MRI) changes, determine whether certain brain MRI changes are linked to seizures and~     define the common seizure treatment regimens.~   "
123420|NCT01952015|"~     The purpose of this study is to assess efficacy and safety data of secukinumab in Japanese~     subjects with generalized pustular psoriasis (GPP). This study is expected to support the~     filing of secukinumab in the indication of pustular psoriasis in Japan.~   "
123421|NCT01952002|"~     The aim of this study is evaluate the clinical, hemodynamic and electrocardiographic~     responses during an inspiratory muscle training session during a single cardiopulmonary~     rehabilitation session program. An electrocardiogram will be continuously recorded and the~     heart rate (HR) and blood pressure (BP) will be evaluated before, during and immediately~     after a single inspiratory muscle training (IMT) session, consisting of two series of 15~     cycles, with one-minute intervals between sets and an initial load of at least 30% of the~     initial maximal inspiratory pressure (MIP).~   "
123434|NCT01951833|"~     The current dream in CF research is to discover safe drugs that correct the basic defect and~     prevent lung disease, allowing patients without significant lung damage to live nearly normal~     lives with a dramatic increase in life expectancy and without the burden of current~     treatment. The compound VX-770 (Ivacaftor Ò) is hoped to be the first milestone along this~     way. Progression of lung disease is now so gradual in many centres that sensitive indicators~     of early lung disease (small airways disease) are critically needed to assess the effects of~     such new treatments. In this context, assessment of ventilation inhomogeneity by the~     measurement called Lung clearance index (LCI) seems to be the most promising tool. However,~     to get approval by health authorities, new measures used in drug evaluation need to fulfill~     strict criteria. For LCI, the investigators still need to prove its long term significance:~     How well does the LCI measurement predict the long term lung disease course? Therefore, in~     this study the investigators want to measure LCI at baseline in a large patient cohort and~     establish how well it predicts the patients' disease course over the next 2 years.~   "
123435|NCT01951820|"~     The efficacy of the topical anesthetics will be determined by how much pain the patient felt~     (using a Heft-Parker pain analog scale) upon needle penetration.~   "
123422|NCT01951989|"~     Rational: Imiglucerase has been used to treat Gaucher disease since 1997 but data about its~     pharmacokinetics have been partial; investigators know that imiglucerase undergoes a quick~     clearance from plasma compartment following the infusion (1/2 life: 1-6 min, from tissue:~     <24h), an observation apparently contradictory with usual infusion rhythm (one infusion every~     two weeks). Furthermore, by going by GD response, the rhythm of Infusion is sometimes~     diminished (for example, every 3 or 4 wks) without pharmacological rational ; In parallel,~     investigators demonstrated that monocytes represent a satisfactory surrogate of GD target~     cells and that enzyme activity into monocytes varies between individuals.~      Our hypothesis is that enzyme activity into monocyte compartment could be different and could~     be related to GD response.~      Primary purpose: to evaluate the pharmacokinetics of Imiglucerase activity into target~     cellular compartment depending on dose and frequency of infusions.~      Secondary purposes : 1) to establish a possible relationship between the intra-monocytic~     activity of glucocerebrosidase and the clinical and biological activity of Gaucher disease~     and to define a possible threshold value of enzyme activity; 2) to establish a better~     correlation with known biomarkers of disease (routine markers and markers recently~     identified), which would better predict and / or monitor response to treatment ; 3) to~     compare the residual and natural rate of activity enzyme intra-monocytic for untreated~     patients (low severity disease).~   "
123423|NCT01951976|"~     The purpose of this study is to determine whether it might be practical and useful to~     investigate the effectiveness of yoga classes in relieving joint pain associated with the use~     of a class of medications known as aromatase inhibitors.~   "
123424|NCT01951963|"~     The proposed trial is a prospective, double blinded, randomized control trial with the~     primary aim of determining whether a single, sub-dissociative dose of ketamine will decrease~     the total narcotic requirements of pediatric patients requiring intravenous analgesia in an~     urban emergency department (ED) compared to a group of patients who receive morphine alone~     for pain management. Patients are randomized to receive either a single bolus of ketamine~     (0.3 mg/kg) or a single bolus of morphine (0.05mg/kg). All subsequent pain management will be~     accomplished using morphine. Patient, family member, and research staff pain scores will be~     recorded, until 3 hours post study medication administration. Family members are contacted~     via telephone 24 hours post-ED discharge, and again at 7 days post-hospital discharge, for~     evaluation via Post Hospitalization Behavior Questionnaire. Narcotic equivalents will be~     calculated for up to 3 hours post study medication administration and compared between the~     ketamine and morphine groups.~   "
123425|NCT01951950|"~     Emergence hypertension is a common occurrence in patients emerging from general anesthesia.~     This elevation of arterial pressure is particularly concerning in patients undergoing~     craniotomy due to increased risk of morbidity and mortality in patients with altered~     intracranial elastance. Thus, identifying better methods to attenuate the hemodynamic changes~     associated with emergence from anesthesia can improve patient safety, especially in the~     neurosurgical patient.~      Study Hypothesis: Nicardipine is more effective than esmolol as a sole agent in maintaining~     blood pressure within goal range in the setting of emergence hypertension after craniotomy.~   "
123426|NCT01951937|"~     In the FINS study we test - in a randomized non blinded intervention study- the hypothesis~     that increased intake of salmon will improve cognitive performance of children aged 4 years~     to 6 years in the Munich area (Germany), who habitually consume little fish.~   "
123427|NCT01951924|"~     The aim of this study is to evaluate the efficacy and safety of I10E (LFB 10% ready-to-use~     liquid human intravenous immunoglobulin) compared to Kiovig® for the maintenance treatment of~     MMN in a randomized, double-blind, active comparator-controlled, cross-over trial.~   "
123428|NCT01951911|"~     To see whether the addition of low-dose ketamine to a subcutaneous morphine infusion improves~     analgesia in patients with neuropathic cancer pain.~   "
123429|NCT01951898|"~     Montelukast is one of anti-inflammatory agents and a good controller for the patients with~     asthma. The hypothesis of the study is that the Montelukast will have airway~     anti-inflammatory effects and up-regulated regulatory T cells functions in asthma.~   "
123430|NCT01951885|"~     This randomized clinical trial studies standard GVHD prophylaxis with tacrolimus and~     methotrexate compared to tacrolimus, mycophenolate mofetil and a reduced-dose methotrexate in~     patients with hematologic malignancies undergoing allogeneic hematopoietic cell transplant.~     Both mycophenolate mofetil and reduced-dose methotrexate, in combination with a calcineurin~     inhibitor, have been shown to be safe and effective in GVHD prevention with less toxicity~     than standard dose methotrexate. It is not yet known, however, whether this combination of~     mycophenolate mofetil and reduced-dose methotrexate with tacrolimus is more effective than~     tacrolimus and standard dose methotrexate in preventing GVHD.~   "
123431|NCT01951872|"~     Recent research has shown that some individuals become addicted to or dependent on caffeine~     and are unable to quit or reduce caffeine consumption despite a persistent desire to do so.~     The aims of the current study are to characterize caffeine use among individuals with~     physical or psychological dependence on caffeine and evaluate a manual-based intervention to~     promote caffeine reduction and cessation.~   "
123432|NCT01951859|"~     This is a study whose primary objective is to assess the effectiveness of Neuropathy/Ulcer~     Cream in the promotion of healing skin fissures plantar foot ulcers and as a moisturizer to~     prevent dry skin turning into ulcers as compared with a placebo cream containing the same~     vehicle as Neuropathy/Ulcer Cream without the active ingredients (Control).~   "
123433|NCT01951846|"~     The primary objective of this study was to determine the maximum tolerated dose (MTD) of BIBF~     1120 in patients with solid tumours by the monitoring of drug-related adverse events.~     Secondary objectives were the evaluation of safety, efficacy, pharmacokinetics, and~     pharmacodynamics.~   "
123436|NCT01951807|"~     Subjects that have received medical treatment for ovarian cancer can be both physically and~     emotionally demanding for patients. The purpose of this study is to determine whether two~     common pyschological interventions (Communication Skills Intervention and Supportive~     Counseling) may improve the well-being of ovarian cancer patients compared to usual care.~   "
123437|NCT01951794|"~     Validate a promising community survey methodology for evaluating the Prevention of Mother to~     Child Transmission (PMTCT) program effectiveness against a gold standard cohort design and~     to identify individual- and facility-level characteristics associated with HIV-free survival~     among HIV-exposed infants.~   "
123438|NCT01951781|"~     Diagnosis of late-onset sepsis is difficult in the absence of specific clinical signs and~     biological markers in the infection initial phase .The aim of this study is to determine the~     performance of a new infection marker : Neutrophil CD64 for early diagnosis in nosocomial~     infection (NI) in preterm newborns.~      METHODS :~        -  Monocentric prospective study including preterm newborn infants (<37 weeks of~          gestationnal age ) with clinical suspicion of nosocomial infection in a neonatal~          intensice care unit (Neonatal intensive care unit of Montpellier, France).~        -  Patients will be enrolled in the study after informed consents. Rapid and automated CD64~          measurment will be realized during the conventional blood sample including C-Reactive~          Protein (CRP), Procalcitonin (PCT) and blood culture.~        -  Broad-spectrum antibiotic therapy can be started on the advice of clinician and blinded~          the result of CD64. Patients will be then classed in three groups using CDC criteria~          (center for disease control) : 1-no infection, 2-infection, 3-possible infection during~          the multidisciplinary staff. Specificity, sensitivity, negative and positive value of~          CD64 will be calculated and the performances of CRP, PCT and CD64 will be compared.~           153 patients are needed in the study enrolled during a period of 12 months.~      PERSPECTIVES Neutrophil CD64 monitoring might be help clinicians to manage nosocomial~     infections in neonates.CD64 allow to integrate in a decision algorithm with the determination~     of the best cut-off value to faster processing nosocomial infections and could help to reduce~     unnecessary antibioc therapy. A rapid technique for determination of CD64 should be readily~     available in our unit.~   "
123439|NCT01951768|"~     The purpose of this study is to determine whether Garamycin Sponge (Gentamicin-Collagen~     sponge) in combination with antibiotics is safe and effective in treating moderate and severe~     diabetic foot infections.~   "
123440|NCT01951755|"~     An open-label, non randomized clinical trial of Tarceva as single agent in progressed~     non-small cell lung cancer patients.~   "
123441|NCT01951742|"~     The purpose of this study is to establish the therapeutic range of ANT-1401 in the treatment~     of Crow's Feet.~   "
123442|NCT01951729|"~     Glucose-dependent insulinotropic polypeptide (GIP) is a hormone produced in the intestine. It~     is released immediately after meal ingestion and increases insulin release. This, in turn,~     helps reduce blood glucose levels. This circuit does not work properly in humans with type 2~     diabetes mellitus (T2DM).~      We have previously shown that a peptide called xenin-25 can amplify the effects of GIP on~     insulin secretion in humans. However, xenin-25 no longer does this when humans develop T2DM.~     Thus, it is important to understand how xenin-25 works in humans without T2DM so we know why~     it does not work in humans with T2DM.~      Acetylcholine is molecule produced by specific types of nerves. The effects of acetylcholine~     can be blocked by a drug called atropine. We have previously shown in mice that atropine~     prevents the ability of xenin-25 to increase the effects of GIP on insulin release. The~     purpose of this clinical trial is to determine if atropine also blocks the effects of~     xenin-25 in humans without T2DM. If it does, then impaired acetylcholine signaling may be one~     of the reasons humans develop T2DM and it could be possible to develop drugs that bypass this~     defect and increase insulin release in humans with T2DM.~   "
123443|NCT01951716|"~     Glucose-dependent Insulinotropic Polypeptide (GIP) and xenin-25 are peptide hormones~     produced/released from your intestines and help regulate blood sugar levels after you eat. We~     have previously performed studies in humans that measured the effects of xenin-25 and GIP~     (alone and together) on blood sugar levels. One study was conducted with an intravenous~     infusion of glucose but without ingestion of a meal. In this study, xenin-25 increased the~     effects of GIP on insulin secretion- but only in humans without type 2 diabetes mellitus~     (T2DM). A second study was conducted in conjunction with ingestion of a meal. In this study,~     xenin-25 reduced blood glucose levels by delaying gastric emptying and this effect was~     similar in humans with and without T2DM. A variety of studies that we have performed suggest~     that xenin-25 works by activating nerves. A specific nerve called the vagus nerve plays an~     important role in regulating insulin secretion. This study will determine if the vagus nerve~     (which was disrupted if you had a vagotomy) is needed for the effects of xenin-25 on insulin~     secretion and/or gastric emptying.~   "
123444|NCT01951703|"~     To evaluate the impact of a new contact lens hydration process~   "
123445|NCT01951690|"~     This is a Phase II, open-label, multicenter, multi cohort, study of VS-6063 (defactinib), a~     focal adhesion kinase inhibitor, in patients with KRAS mutant non-small cell lung cancer~     (NSCLC). NSCLC with a KRAS mutation is required for study entry and subjects will be enrolled~     into 1 of 4 cohorts based on the status of their INK4a/Arf and p53 mutations. The purpose of~     this study is to demonstrate if VS-6063 (defactinib) improves PFS within each cohort. The~     safety and tolerability of VS-6063, tumor response rate, progression free survival and~     overall survival will also be assessed. The pharmacodynamic effects of VS-6063 (defactinib)~     will be examined in a tumor biopsy and a blood sample.~   "
123446|NCT01951677|"~     There is a need for more effective and better-tolerated hepatitis B vaccines for low~     responder high-risk populations including patients with renal impairment and/or diabetes~     mellitus and those aged over 40 years. Several approaches are available to enhance the~     potency of hepatitis B virus vaccines including use of the more highly immunogenic antigens,~     replacing alum with potentially more effective adjuvants, and increasing the dose of vaccine~     antigen. A combination of these strategies is being tested in this study to identify the most~     promising candidate approaches to take forward into advanced clinical development~   "
123447|NCT01951664|"~     Treatment for head and neck cancer can result in marked musculo-skeletal impairment (MSI).~     This study will examine the effects of Hatha Yoga as a therapeutic modality to address MSI.~   "
123448|NCT01951651|"~     The purpose of this study is to examine the effect of exenatide on liver and heart~     (myocardial) fat and inflammation.~   "
123449|NCT01951638|"~     Objective of the study is to find the optimal dose of the once daily oral soluble guanylate~     cyclase stimulator (sGC) BAY1021189 for Phase III that can be given in addition to standard~     diuretic and comorbidity treatment for heart failure with preserved ejection fraction (HFpEF)~   "
123450|NCT01951625|"~     Objective of the study is to find the optimal dose of the once daily oral soluble guanylate~     cyclase stimulator (sGC) BAY1021189 for Phase III that can be given in addition to standard~     therapy for heart failure with reduced ejection fraction (HFrEF).~   "
123451|NCT01951612|"~     Stroke is a leading cause of disability; most strokes (80%) are subcortical, with ischemic~     damage due to occlusion in penetrating arteries. Although ischemic white matter disease~     (iWMD) may lack gross clinical manifestation, it causes significant cognitive impairment,~     particularly on measures of executive function, attention, and memory. This impairment is~     attributable to diffuse damage affecting network connections.~      While there are many studies concerning rehabilitation of motor function and language in~     patients with large focal strokes, few studies have addressed attentional and executive~     functions. To our knowledge, there are no such studies on iWMD. In this study, patients will~     be randomized to a novel intervention for improving executive function and a control~     condition matched for therapist exposure. Patients will be assessed pre-intervention,~     post-intervention, and at long-term follow-up using a battery of behavioural and neuroimaging~     tasks. We predict that the novel intervention will be associated with improved executive~     function, as assessed behaviourally, and improved frontal network function, as assessed~     through neuroimaging markers.~   "
123452|NCT01951599|"~     To determine the relative bioavailability of different oral formulations of AZD9291 and the~     effect of food in healthy volunteers.~   "
123453|NCT01951586|"~     This randomized phase 2 trial is studying the effect of adding denosumab to standard~     chemotherapy in the treatment of advanced lung cancer.~   "
123454|NCT01951573|"~     The purpose of this study is to demonstrate non-inferiority of a new daily disposable~     multifocal contact lens in plus powers against the commercially available AIR OPTIX® AQUA~     MULTIFOCAL (AOAMF) lens in high contrast/high illumination (HC/HI) near visual acuity (VA).~   "
123455|NCT01951560|"~     The purpose of the first part of this study is to determine the safety and tolerability of~     ascending doses of valproic acid (also known as Depacon) administered as intravenous infusion~     (IV) in doses ranging from 15 mg/kg to 250 mg/kg in healthy subjects.~      The second part of the study will also be to determine the safety and tolerability of single~     ascending doses of valproic acid administered as IV in trauma subjects with hemorrhagic~     shock.~   "
123456|NCT01951547|"~     Periodontitis, a chronic inflammatory disease which results in irreversible attachment loss,~     bone destruction and tooth loss, is a major oral health problem affecting 90.2% of Malaysian~     population. It was initially demonstrated that Type 2 Diabetes (T2D) was a risk factor for~     periodontitis and subsequently a two-way relationship between diabetes and periodontitis was~     proposed. Diabetes has been shown to cause defects in neutrophil function by overproduction~     of pro-inflammatory mediators such as Tumour necrosis factor-α, Interleukin-1β and~     Prostaglandin E2 by macrophages. The inflammatory mediators released in response to plaque~     have been reported to be insulin antagonists that disturb binding of insulin to its receptors~     and further complicate hyperglycaemia in T2D. The hyperglycaemia in diabetics promotes more~     pathogenic bacteria into the subgingival microenvironment making them more susceptible to~     chronic periodontitis. Studies however differ in the types of periodontal pathogens present~     in these pockets. At the same time, very few studies have quantified them. This study~     proposes to investigate the effect that non-surgical periodontal therapy (NSPT) has on the~     periodontal parameters, HbA1c levels, microbiological profile and CRP levels of T2D patients~     with chronic periodontitis as compared to oral hygiene education (OHE)alone.~   "
123457|NCT01951534|"~     This is an intervention development and pilot study whose purpose is to determine the~     feasibility and acceptability of the breast reconstruction decisional aid (BRDA) and provide~     preliminary data on its impact on decisional outcomes.~      The primary aim of this study is: Is the intervention trial feasible? The purpose is to~     develop a feasible web-based decisional aid (DA) for a larger scale trial. Thus it is~     important that this trial provide evidence of feasibility. The investigators will define~     feasibility as the rate of study acceptance and participation.~      The secondary aim of this study is:  Is the BRDA acceptable and used? The team will~     evaluate BRDA acceptability, use, difficulty with internet use, and what factors predict~     uptake and use. The investigators anticipate that, due to interest in the topic, the majority~     of women will access the website.~      An additional secondary aim of this study is: What is the impact of BRDA on BR knowledge,~     attitudes about BR, decisional conflict, preparedness and completeness of preparation,~     anxiety, and discussion with oncologist? The purpose is to calculate effect sizes for a~     larger randomized trial.~   "
123458|NCT01951521|"~     Randomized controlled trial in which the effect is investigated of a radiation boost in~     addition to standard chemoradiation in patients with locally advanced rectal cancer on~     complete response rate defined as pathological complete response, in those who undergo~     surgery, or 2-years local recurrence-free survival (2y-LRFS), in those who opted for a wait~     and see approach. Secondary objectives are adverse events due to chemoradiation (acute,~     perioperative and late toxicity), tumor response assessed with MRI, the impact of the boost~     on local and distant recurrence and survival as well as patient-reported quality of life and~     workability. The need for this comprehensive study is emphasized by the sub-optimal~     (radiation-) methods, heterogeneity between and poor reporting in the few previous trials in~     this field.~   "
123459|NCT01951508|"~     The purpose of this study is to investigate effects of methylphenidate, modafinil, and~     3,4-methylenedioxymethamphetamine (MDMA, Ecstasy) on emotion-processing and cognitive~     performance using functional magnetic resonance imaging (fMRI) techniques. The primary~     hypothesis is that these psychostimulants differentially affect processing of emotional~     stimuli and potentially leading to alterations in social cognition and behavior.~   "
123460|NCT01951482|"~     This is a multi-center phase II randomized controlled study to assess the efficacy of~     Pemetrexed/cisplatin with or without Bevacizumab on patients with brain metastasis from~     non-small cell lung cancer(NSCLC) harboring EGFR wild type by intracranial PFS(iPFS),also PFS~     ,DCR and OS.The side effect is evaluated as well.~   "
123461|NCT01951469|"~     This is a multi-center phase II randomized controlled study to assess the efficacy of~     Gefitinib alone and Gefitinib combinating with Pemetrexed/cisplatin on patients with brain~     metastasis from non-small cell lung cancer(NSCLC) harboring EGFR mutation type by~     intracranial PFS(iPFS),also PFS ,DCR and OS.The side effect is evaluated as well.~   "
123462|NCT01951456|"~     The purpose of this study is to determine whether resistance training can aid smoking~     cessation.~   "
123474|NCT01951300|"~     This study investigates whole-body distribution kinetics of intravenously administered~     Gallium-69 (68Ga) citrate by positron emission tomography (PET)/computed tomography (CT).~     Thereafter, radiation dosimetry of 68Ga-citrate PET/CT will be determined.~   "
123463|NCT01951443|"~     The purpose of the study is to evaluate the acute effect of a standardized extract of KRG~     (Rg3-KRG) consisting of 30% total ginsenosides, including 10% Rg3 ginsenoside on arterial~     stiffness and blood pressure, as measured by the following parameters: aortic augmentation~     index, peripheral blood pressure, central blood pressure~   "
123464|NCT01951430|"~     The purpose of this study is to observe the number of new cases of infections per population~     in a given time period and their characteristics in a pathology (myelodysplastic syndrome,~     MDS)that involves ineffective production (or dysplasia) of a class of blood cells.~   "
123465|NCT01951417|"~     This is an open-label, multi-center study to be conducted in the United States. The study~     will examine the change in lesion count in subjects using Epiduo® Gel Pump (once daily) in~     conjunction with Cetaphil® DermaControl™ Foam Wash (twice daily) and Moisturizer SPF 30 (once~     daily). Subjects with a clinical diagnosis of mild or moderate acne who are eligible for~     treatment with Epiduo® in accordance with the currently approved product labeling and who~     meet other inclusion/exclusion criteria are to be enrolled in the study and receive the study~     products for 8 weeks. Efficacy and safety assessments include: complete lesion counts,~     cutaneous irritation assessment, end of study treatment questionnaire, photographic~     evaluation for oiliness, skin tone, and P Acnes, hydration assessment, barrier function~     assessment, treatment compliance, and adverse event assessment.~   "
123466|NCT01951404|"~     Kidney patients on dialysis commonly die because of heart disease. One of the biggest~     problems in their hearts is that the muscle wall of the heart thickens. This makes it less~     efficient. We found in patients with mild kidney disease that a drug normally used to treat~     gout (allopurinol) had the remarkable side effect of being able to reduce this thickening of~     their heart wall. In this new study we aim to find out if this benefit of allopurinol also~     occurs in severe kidney patients i.e. those on regular dialysis. We also are trying to figure~     out the best dose of allopurinol to use. To do this we are planning a study where we will~     recruit patients with kidney disease who are on dialysis. The 1st phase of the trial will be~     to determine the best dose of allopurinol to use and the second phase will be to do a~     clinical trial where patients will be randomly allocated to either this optimum dose of~     allopurinol or a dummy medication (placebo) and will receive one year of treatment. They will~     have a special scan of the heart using an MRI machine to measure the extent of thickening of~     their heart muscle before they start on treatment and will have a further MRI scan when their~     one year treatment finishes.~      Phase 1- the dose finding study, will involve 10 patients who will have between 3 and 7~     visits to the hospital scheduled around 4 to 17 dialysis sessions. The later study will~     involve up to 76 patients who will be asked to attend the hospital up to 8 times over a 13~     month period.~   "
123467|NCT01951391|"~     Up to 20 volunteers will be recruited to evaluate the microbial environment on their~     forearms. Following informed consent, bacterial swabs will be obtained on day 0 from the~     forearms of all subjects. Their forearms will then be washed with one of the study cleansers.~     Subjects will then be instructed to return at different timepoints over the next several days~     for repeat bacterial swabbing of their forearms. For the first 10 participants, these~     timepoints will be every 24 hours for a total of 3 days. For the following participants,~     these timepoints will be at 10 minutes, 6 hours, and 24 hours after the wash. DNA will be~     extracted from all swabs and bacterial diversity evaluated by 16S pyrosequencing.~   "
123468|NCT01951378|"~     The primary objective will be, in an open-label randomized trial, a comparison of emergency~     department (ED) length of stay (LOS) between children experiencing acute asthma treated with~     two different nebulizers. Secondary outcomes will include admission rates, hospital LOS, need~     for additional therapies, transfers to a higher level of care, side-effects, and unscheduled~     return visits~   "
123469|NCT01951365|"~     Spinal intradural schwannoma detected incidentally increased recently. Because there is~     little knowledge about natural history of spinal schwannoma, there is no consensus of~     treatment. Our hypothesis is as follows;~        1. Some schwannomas keep growing, the others do not.~        2. Foraminal schwannomas do not usually grow.~      The investigators analyzed natural history and characteristics of 56 spinal schwannomas~     observed initially with accurate and reliable methods. Here the investigators displayed~     growing pattern and differential point of spinal schwannoma.~   "
123470|NCT01951352|"~     In this study we will test the ability of different commercially available hand soaps to~     effect the amount of anti-microbial peptides present on the surface of the human skin after~     washing with these soaps. Based on our experiments on pig skin, we expect the amount of~     antimicrobial peptide expression to decrease after using these different soaps.~   "
123471|NCT01951339|"~     The goal of this study is to examine whether sitagliptin, an agent which enhances the action~     of hormones that control the release of insulin and is already in clinical use for type 2~     diabetes, might also improve functional exercise capacity.~      Specific aims:~      1. To test whether sitagliptin will improve functional exercise capacity in persons with type~     2 diabetes compared to glimepiride.~      1a. The primary outcome will be peak oxygen consumption (VO2peak) and oxygen uptake kinetics~     (VO2 kinetics).~      1b. Secondary outcomes include cardiac function, endothelial function and tissue oxygen~     saturation (STO2) as well as health-related quality of life.~      2. To evaluate the impact of sitagliptin on muscle mitochondrial function 2a. The primary~     outcome to address this aim will be 31P measurements (phosphocreatine, free inorganic~     phosphate, adenosine triphosphate peaks, adenosine diphosphate and pH)~      Impact: Novel approaches are needed to decrease excess cardiovascular morbidity and mortality~     in diabetes. Diabetes impairs cardiovascular fitness and thereby mortality. A demonstration~     that sitagliptin improves cardiovascular fitness, (and possibly mitochondrial function) will~     provide important new data pertinent to the management of diabetes and pre-diabetes.~   "
123472|NCT01951326|"~     The investigators hypothesize that RHB-104 will have greater efficacy than placebo in Crohn's~     disease.~   "
123473|NCT01951313|"~     The 2010 Dietary Guidelines for Americans emphasizes consumption of 4.5 cups of fruits and~     vegetables daily but average intake of US adults is only 2.6 cups. This low consumption of~     fruits and vegetables results in limited availability of certain nutrients found in these~     foods such as carotenoids. Dietary carotenoids have health beneficial properties and are~     known to fight against disease. Eggs are known to be a good source of carotenoids and eggs~     may improve the absorption of carotenoids found in co-consumed fruits and vegetables.~     Therefore, we are interested to see if consuming eggs with a mixed-vegetable salad will~     increase carotenoid absorption.~   "
123475|NCT01951287|"~     Blood sugar and insulin levels after a meal may be altered by the food and beverages a person~     consumes. Keeping a healthy blood sugar level may help prevent and manage type 2 diabetes and~     related diseases. This study will look at how drinking different common beverages (milk,~     low-fat milk, nonfat milk, orange juice, coffee, and water) with a meal changes blood sugar~     and insulin levels.~   "
123476|NCT01951274|"~     A study of a several doses of a novel treatment for chronic itch compared to placebo for~     patients whose condition has not responded to other treatments~   "
123477|NCT01951261|"~     To determine if an early assisted discharge program for acute exacerbations of COPD (AECOPD),~     with telemonitoring and telephone control, is equally effective and more efficient in terms~     of use of health care resources, that a home care provided by hospital respiratory nurses and~     pulmonologists.~   "
123478|NCT01951248|"~     The purpose of this study is to investigate the effect of 3 months of continuous positive~     airway pressure (CPAP) treatment of obstructive sleep apnea (OSA) in moderate to severe cases~     in patients with chronic kidney disease. The effect is evaluated on blood pressure levels,~     particularly nocturnal blood pressure, both central and peripheral, and renal function,~     including the kidneys treatment of salt and water.~      Hypothesis:~        1. Central 24-h blood pressure measuring is a reveals fluctuations in blood pressure during~          the day more accurately than peripheral 24-h blood pressure measuring because the~          measurement is painless and does not interfere with the patient activities during the~          daytime or nighttime sleep.~        2. Central blood pressure is elevated in patients with OSA and falls during treatment with~          CPAP.~        3. The renal tubular function relating to the treatment of water and sodium is abnormal in~          patients with OSA with increased tubular absorption of water via the U-aquaporin 2~          (u-AQP2) and of sodium by epithelial sodium channel (ENAC) and is normalized during~          treatment with CPAP.~      4 Quality of life is improved during treatment with CPAP.~   "
123479|NCT01951235|"~     This study will assess the efficacy and safety/tolerability of 4 doses of Imeglimin versus~     placebo. The study will be performed in subjects with type 2 diabetes either naive of~     treatment or previously treated with an oral monotherapy excluding thiazolidinedione.~   "
123480|NCT01951222|"~     Recent large clinical studies have demonstrated the interest of LAMA therapy in the~     management of asthma, when compared to LABA.~      V0162 is a compound with a very long lasting bronchodilator effect when compared to reference~     treatment in non-clinical models and in COPD patients. Secondary properties of V0162~     (i.e.H1/H4 and PDE IV-inhibition) could enhance the efficacy of this antimuscarinic compound~     and could bring option in the treatment obstructive lung disease. The objective of the study~     is to assess the bronchodilator properties of V0162 during 8 days in adult patients with~     asthma usually treated with ICS and LABA. The study is a randomised, double-blind,~     placebo-controlled, 3-period crossover, preceded by an open-label active-control period~     before randomisation.~   "
123481|NCT01951209|"~     Hepatitis C is the leading cause of chronic liver disease and cirrhosis in United States~     veterans. Cirrhosis is associated with impaired antibody responses and increased risk of~     bacterial infections. We have recently identified that cirrhosis is associated with~     abnormalities of memory B-cells, cells that make antibodies and help protect against~     bacterial infections. We have identified that chemicals associated with gut bacteria might~     play a role in causing these B-cell abnormalities. It is well known that gut bacteria have~     increased access to the blood in individuals with cirrhosis, a process called bacterial~     translocation. We hypothesize that reducing bacteria counts in the gut by using~     poorly-absorbed antibiotics (also known as selective gut decontamination) will partially~     reverse losses of memory B-cells in cirrhosis by reducing bacterial translocation.~   "
123482|NCT01951196|"~     A new study have shown that high nighttime blood pressure (BP) and/or non-dipping (lack of~     fall in blood pressure during nighttime) is a strong predictor for the risk of cardiovascular~     disease and mortality in patients with hypertension. Three factors seem to affect the night~     time blood pressure: chronic kidney disease, obstructive sleep apnea (OSA) or the way~     ambulatory blood pressure is monitored.~      The aim of this study is to analyse the importance of these three factors on nighttime~     bloodpressure.~      Hypothesis:~      Central 24 hour blood pressure monitoring provides another measure of daily fluctuations in~     blood pressure than peripheral 24 hour blood pressure monitoring, because measurement is~     painless and does not interfere with activities during the daytime or night-time sleep~      In chronic kidney disease and OSA the decrease in nocturnal BP is lower than in healthy~     subjects.~      In chronic kidney disease the decrease in the nocturnal BP is inversely correlated to the~     severity of OSA, the severity of kidney disease, and blood pressure during daytime.~   "
123483|NCT01951183|"~     This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will~     evaluate the efficacy, safety and tolerability of RO6811135 in Type 2 diabetic patients~     treated with a stable dose of metformin.~   "
123484|NCT01951170|"~     This open-label, single-arm study will evaluate the efficacy and safety of tocilizumab in~     patients with active moderate to severe rheumatoid arthritis. Participants will receive a~     subcutaneous dose of tocilizumab 162 mg once weekly. The anticipated time on study treatment~     is 24 weeks.~   "
123485|NCT01951157|"~     A clinical study of lurbinectedin(PM01183) alone or in combination with gemcitabine in~     comparison to docetaxel for the treatment of unresectable non-small cell lung cancer~     (NSCLC)patients~   "
123486|NCT01951144|"~     The purpose of this study in healthy people is to evaluate safety, toleration and time course~     of plasma concentration of single oral doses of PF-06372865. The pharmacodynamic activity of~     PF-06372865 will also be assessed. The effect of food on PK and the PK of PF-06372865~     administered as a tablet formulation may also be investigated. Pharmacodynamic interaction~     between PF-06372865 and lorazepam will be evaluated.~   "
123499|NCT01950962|"~     This is a transversal double-centre study. Patients will be recruited from outpatient~     consultations. They will have buccal inflammation caused by periodontal disease (frequent~     oral infections, mostly with GRAM (-) bacteria). Three groups of 80 patients, corresponding~     to slight, moderate and severe periodontal disease, will be formed according to the results~     of radiological and clinical examinations.~   "
124198|NCT01941849|"~     The phase I trial aims to determine the recommended phase II dose (RP2D) of vandetanib in~     combination with standard radiation therapy, 131I-mIBG, in patients with advanced~     phaeochromocytoma (phaeo) and paraganglioma (PG) by assessing the safety and tolerability of~     the combination treatment.~   "
123487|NCT01951118|"~     Olfactory identification deficits occur in patients with Alzheimer's disease (AD), are~     associated with disease severity, predict conversion from mild cognitive impairment (MCI) to~     AD and are associated with healthy elderly subjects developing MCI. Odor (olfactory)~     identification deficits may reflect degeneration of cholinergic inputs to the olfactory bulb~     and other olfactory brain regions. Acetylcholinesterase inhibitors (ACheI) like donepezil~     show modest effects in improving cognition but can be associated with adverse effects and~     increased burden and costs because of the need for prolonged, often lifelong, treatment.~     Converging findings on odor identification test performance (UPSIT, scratch and sniff 40-item~     test) from four pilot studies, including two of our own, suggest that acute change in the~     UPSIT in response to an anticholinergic challenge (atropine nasal spray), incremental change~     over 8 weeks, and even the baseline UPSIT score by itself, may predict cognitive improvement~     with ACheI treatment in MCI and AD. If change in odor identification deficits can help to~     identify which patients should receive ACheI treatment, this simple inexpensive approach will~     advance the goal of improving personalized treatment, improve selection and monitoring of~     patients for ACheI treatment, reduce needless ACheI exposure with risk of side effects, and~     decrease health care costs.~   "
123488|NCT01951105|"~     This study aims to determine if early treatment with Carbidopa/Levodopa and Naproxen in~     individuals with sub-acute back pain (SBP) is associated with changes in blocking transition~     to chronic back pain (CBP).~   "
123489|NCT01951092|"~     Despite advances in antiretroviral treatment (ART) over the past 10 years, the incidence of~     HIV in the United States remains stagnant with over 50,000 new cases annually. HIV-infected~     individuals inconsistently engaged with care are less likely to receive ART which is~     associated with correspondingly adverse clinical outcomes in the long term and increased risk~     of transmission. Mobile health (mHealth) strategies including cell phone and text messaging~     have shown success in the developing world for medication adherence, yet mHealth~     interventions have not been developed to improve retention in HIV care. This strategy needs~     to be tested to demonstrate feasibility, acceptability and preliminary effectiveness in~     supporting HIV treatment adherence in Rhode Island.~      The Miriam Hospital Immunology Center is an urban HIV-clinic that provides comprehensive~     primary and specialty care for over 1400 HIV-infected patients. It is the largest HIV clinic~     in Rhode Island with patients also referred from eastern Connecticut and southern~     Massachusetts. In 2010, there were 165 new patients in clinic, 70 of whom were diagnosed~     within 1 year of entering care. In this environment, we propose a pilot study with the~     following specific aims:~      Specific Aim 1: To pilot a bidirectional mHealth intervention among individuals at high risk~     of loss to follow-up, including those with a recent HIV diagnosis or those re-engaging in HIV~     care. HIV-infected persons (n=30) with a recent diagnosis or re-engaging in care at the~     Immunology Center at TMH will be recruited to participate in a bidirectional mHealth~     intervention that delivers automated, regularly scheduled appointment and medication~     adherence reminders in an individualized format, and also allows individuals to request~     motivational enhancement and problem-solving support to address barriers to care.~      Specific Aim 2: To assess the impact and acceptability of the pilot intervention through~     qualitative interviews. All participants will also be invited to complete individual in-depth~     interviews which will assess acceptability and effectiveness of the pilot mHealth~     intervention, such as content and frequency of automatic messages, for retention and~     medication adherence for HIV-infected individuals in RI.~      The results of this study will provide preliminary data to inform an R21 or R34 application~     to determine efficacy of an mHealth intervention among HIV-infected persons at high-risk for~     loss to follow-up.~   "
123490|NCT01951079|"~     In second trimester abortion above 22 weeks the investigators usually inject intra-cardiac~     Kcl for feticide. Digoxin intra-amniotic injection has been described in the literature in~     doses of 1-1.5 mg. with a success rate of about 80%, and up to 24 weeks. Our aim in this~     study is to investigate the safety and success rate of 1.5-2 mg. digoxin, intra-amniotic up~     to 30 weeks pregnancy .~   "
123491|NCT01951066|"~     To measure various pro-permeability factors in the aqueous humor of patients with~     persistent/recurrent diabetic macular edema~   "
123492|NCT01951053|"~     The purpose of the study is to evaluate the effect of JNJ-40411813 on rapid eye movement~     sleep and deep sleep; safety, tolerability and pharmacokinetics (what the body does to the~     study medication) of JNJ-40411813.~   "
123493|NCT01951040|"~     This study was designed as a retrospective cohort study where patients given synthetic~     oxytocin during labor induction were considered as the exposed cohort, and patients not given~     oxytocin formed the non-exposed cohort. Four hundred of the 7465 children born at our~     maternity during 2006 were randomly selected. Information about breast-feeding was available~     for 316 of these children. Eventual confounding or adjustment factors were analyzed using~     stratified and multivariate analysis (logistic regression~   "
123494|NCT01951027|"~     pharmacokinetics/pharmacodynamics of GX-G3 after single subcutaneous administration in~     healthy male subjects.~   "
123495|NCT01951014|"~     Currently little is known about the health beliefs and behaviors of pregnant adolescents. The~     goal of this pilot study is to educate pregnant adolescents via social media about nutrition~     and fitness during pregnancy and to evaluate their health beliefs and behaviors before and~     after receiving this information. Data collected will provide new information on which to~     base subsequent research and can be used to inform nutritional guidelines or public health~     programming for this vulnerable age group.~   "
123496|NCT01951001|"~     The purpose of this study is to determine whether the fixed-dose (prasugrel 10 mg/d vs. 5~     mg/d) vs. phenotype (platlet function test by VerifyNow P2Y12 assay)-based prasugrel dose~     adjustment can match therapeutic zone of platelet reactivity in PCI-treated Asians with acute~     coronary syndrome~   "
123497|NCT01950988|"~     The aim is to determine the efficacy and the satisfaction/adaptability of the manual Broscyl®~     toothbrush as compared with a standard  soft  manual toothbrush ADA (American Dental~     Association) reference using the modified Stillman brushing technique, in children, adults~     and elderly persons, after 3 months of daily use.~   "
123498|NCT01950975|"~     The principal result expected is the discovery of inframicroscopic chromosomal rearrangements~     in regions of the genome not yet known to be involved, or mutations in known candidate genes;~      The identification of such a mosaic rearrangement in an affected infant would lead to~     improved genetic counselling. Indeed, as this mosaicism is a consequence of a genetic event~     occurring at an early stage of embryogenesis, it would be possible to confirm the sporadic~     nature of the observed disorder and therefore to predict a very low or even negligible risk~     of recurrence for the couple concerned. For the affected infant, the risk for his/her own~     offspring will be assessed according to the nature of the genetic anomaly discovered. For~     medical practice, investigators hope that this study will lead to a clearer definition of the~     screening modalities for mosaicism in the disorders concerned. In particular, they hope to~     determine whether or not it is possible to dispense with a skin biopsy, which is more~     invasive than a blood sample.~   "
134181|NCT01810978|"~     Infants with congenital heart disease have more frequent infections and exposures to~     antibiotics than healthy infants. The investigators hypothesized that synbiotics may reduce~     the rate of sepsis and necrotizing enterocolitis in infants with CHD~   "
123500|NCT01950949|"~     Mesquida, J et al showed there was a significant linear correlation between pulse pressure~     variations under tidal volume 6 ml/kg and 8 ml/kg in patients after the resuscitation phase~     of severe sepsis and septic shock. No study revealed the actual relationship between various~     PPV under different VT. So we hypothesized that there were relationship between various PPV~     in different tidal volume settings. The objective of this study was to examine the~     relationship between various PPV.~   "
123501|NCT01950936|"~     Title: Pro-to-COLD, Procalcitonin to Chronic Obstructive Lung Disease,~      COLD: Chronic Obstructive Lung Disease, Regarding: Patients hospitalized with suspected acute~     exacerbation of COPD + / - pneumonia.~      Background: Patients with COPD exacerbation often get antibiotics. There is considerable~     criticism of this, many of these patients are not bacterially infected and the antibiotics~     overconsumption can lead to resistance development and side effects.~      The purpose: To show that one can reduce the consumption of antibiotics among patients~     hospitalized for worsening of COPD disease in a population of Danish COPD patients by giving~     antibiotics depending on the value of the biomarker procalcitonin measured in the blood. A~     sub-objective is a validation study of mini VIDAS ® / Biomérieux equipment to the current~     gold standard in measuring procalcitonin, Kryptor/ BRAHMS.~      Subjects: All patients with confirmed/suspected COPD admitted with COPD exacerbation to the~     Acute Admissions Unit/ Pulmonary dept. in weekdays. Participants must be adults and be of age~     and there must be a signed informed consent.~      Method: 1) Controlled (Quasi-randomized): Even and uneven (concealed) digit of patient´s~     danish personal identification number, not last digit (gender-fixed) (CPR-number). Even =~     procalcitonin-guided, Uneven = Control.~      2) Collect and analyze procalcitonin (PCT)-samples of patients in the PCT group at admission~     and then every 2 day. Samples analyzed throughout the week: Vital Status looked up 28 days~     after inclusion. Create a biobank in the study consisting of blood à 8 ml up to a maximum of~     4 times taken for PCT measurements, the subsequent validation study of MiniVIDAS ®. Biobank~     destroyed 15 years after the completed project.~      Statistical considerations:~        1. Sample size / Sample Size:~           A total of 120 patients (please see the basis for this estimate of the Protocol).~        2. Analyze:~      A) Antibiotics stopped on day 5 B) Defined Daily Doses Reads aloud, 1) narrow spectrum, 2)~     broad spectrum, and 3) a total of the two groups between the (Mann-Whitney U test) C)~     Hospitalization within 28 days after the first hospitalization the year - the two groups~     between (Mann-Whitney U test). Doctor Jens-Ulrik Jensen stands for analyzes. Statistics~     program SAS v. 9.1.3 is used.~      Economics: The study funded by the participating departments.~      Responsibility: The study was conceived and run by doctors in Pulmonary Medicine Department~     and Department of Clinical Pharmacology, both Bispebjerg Hospital and Department of Clinical~     Microbiology, Hvidovre Hospital.~      Science Ethics: There has been a thorough research ethics discussion of the project in the~     project with emphasis on an assessment of the advantages and disadvantages that might be for~     the participating patients and society as a whole now and in the future. Conclusions A and B~     of this discussion is summarized as:~      A. Advantages and Disadvantages: The treating physician has at any time the opportunity to~     start / continue antibiotic behandlling for the overall assessment whether PCT value. In~     addition, in the past, in large studies with a total of> 2000 patients, demonstrated that~     there are drawbacks to the use of antibiotics depending on a displayed value of PCT in~     patients hospitalized with acute exacerbations of COPD. Mortality and hospitalization will be~     monitored in this study. However, there may occur side effects to blood sampling, usually~     transient ecchymosis blood sampling site. If the strategy results in a reduced consumption of~     antibiotics, it is expected that the incidence of antibiotic-associated adverse events~     decreased - this for the benefit of the patient.~      B. Usefulness for society: Based on the results from this study will be a high degree of~     certainty to conclude whether this new treatment strategy can provide benefits for future~     patients in the form of reduced antibiotic consumption, less antibiotic associated adverse~     events, reduced resistance development / selection among bacteria and overall lower economic~     costs. Based on these considerations, believes the project, the project can be carried out~     with respect for the participating subjects to integrity.~      Quantity: It is expected to be included 120 patients in this scientific study. Database: data~     (case report forms) stored in archive of Pulmonary Medicine Department for 15 years. Create a~     database with the information. Personally identifiable data will only be present in the~     clinical hospital. During the completion of the experiment can provide essential health~     information about the subject's state of health. This will the subject be informed, unless~     clearly opted out of this on the consent form. The project reported to the Data Protection~     Agency.~      Level: With blood sample (8 mL) on day 1 and then every 2 days in the intervention group (the~     active group), this part of routine blood sampling. At discharge stops blood and the~     patient should not attend the blood after discharge.~   "
123502|NCT01950923|"~     This randomized pilot clinical trial studies sildenafil citrate before surgery in improving~     kidney function in patients with kidney cancer. Sildenafil citrate may help protect the~     kidney from the side effects of surgery and improve kidney function after surgery.~   "
123503|NCT01950910|"~     Amyotrophic lateral sclerosis (ALS) is a motor neuron disease characterized by progressive~     degeneration of motor neurons, muscle atrophy and paralysis. There is no reliable early~     diagnostic test for ALS, making identification of the disease difficult at its earliest~     stages. Early detection is critical to the initiation of early neuroprotective therapy. By~     the time a reliable diagnosis can be made, substantial damage to motor neurons and muscle has~     already occurred. The purpose of the current project is to establish a bank of blood samples~     (serum and protein/RNA/DNA from blood cells) and CSF for use in the development of an early~     diagnostic test for ALS and for better understanding the progression of this disease. The~     main idea of the current study is to examine samples from patients that have a suspected~     diagnosis of motor neuron disease, including patients with ALS who have not progressed far~     enough to be definitively diagnosed as having ALS. Normal and disease control samples will be~     collected for comparison. The investigators will examine various biochemical and metabolic~     markers from these samples, in hopes of finding differences in their expression between~     control subjects and ALS patients and during disease progression. Ultimately, the~     investigators would like to have a panel of markers from the blood that would allow us to~     diagnose and follow the progression of ALS from the earliest possible moment. The data~     collected from this project would give us a basis for a fairly non-invasive, quick and~     clinically relevant test for the early diagnosis of ALS. This in turn would allow us to~     provide earlier intervention for these patients, possibly slowing the damage and improving~     prognosis.~   "
123504|NCT01950897|"~     Muscular dystrophies are caused by mutations in more than 30 genes, some of them remaining to~     be identified. Phenotypically, it is known that one specific mutation can affect the~     expression of several other proteins, causing difficulty in diagnosis. Correct genotyping is~     essential for diagnosis, prognosis and treatment, and relies on a complexed analysis of~     muscle tissues for phenotype profiles. Our research aims to understand how different gene~     mutations affect expression of other genes via muscle biopsy samples and establishment of~     phenotypic profiles for correct diagnosis of individual patients. Establishment of such~     information will be critical for understanding the progression of different muscular~     dystrophies and to devise new experimental therapies. The research will also provide vital~     clues for finding new genes involved in the disease process. Muscle samples may also be used~     to establish cell cultures for testing drugs and new therapies relevant to the treatment of~     the muscular dystrophies.~   "
123505|NCT01950884|"~     -  NAFLD (Non-alcoholic fatty liver disease) has become the most common cause of liver~          disease in Western countries (hepatic manifestation of insulin resistance);~        -  NAFLD represents a cardiovascular risk factor;~        -  Lifestyle modification(weight loss)is the effective medical treatment recommended for~          NASH (Non-alcoholic Steatohepatitis);~        -  Ezetimibe could represent a novel safe treatment for NAFLD (Patel 2006. Here the~          investigators propose a Randomized Controlled Pilot Trial to evaluate the addictive~          effect of ezetimibe on liver histology, biochemical and sonographic parameters in a~          small (n.40) number of NASH patients randomized for 12 months in two arms: lifestyle vs~          lifestyle+ezetimibe.~   "
123506|NCT01950871|"~     The primary objective of the PHSTT-01 trial is to determine if prostate HistoScanning (HS)~     analysis can be used to improve the detection of clinically significant prostate cancer~     (PCa), and potentially reduce the burden and number of biopsies in routine clinical practice.~     Prostate HS is an ultrasound-based tissue characterization technology specifically developed~     to detect, visualize, and locate tissue suspected of harboring PCa. These suspicious tissues~     are displayed as red areas on an imaging monitor. Recently a new biopsy guidance tool has~     been developed that uses the results of the prostate HS analysis.~      The subjects that will participate in this study are all scheduled for a first biopsy of the~     prostate. They will initially be imaged using transrectal ultrasound (TRUS) to obtain data~     for prostate HS analysis. The results of HS analysis will be used later in the procedure.~     Subjects will then undergo a routine systematic 10- to 12-core biopsy procedure using TRUS.~     This will be followed by a TRUS-guided biopsy that uses the result of prostate HS analysis~     and new biopsy guidance tool.~   "
123507|NCT01950858|"~     safety and efficacy of Hyper Baric Oxygen (HBO) in patients presenting with spontaneous~     osteonecrosis of the knee~   "
123508|NCT01950845|"~     Dynamic parameters like pulse pressure variation have been shown to be accurate predictors of~     fluid responsiveness. Hemodynamic optimization based on fluid management and stroke volume~     optimization have been shown to improve patient outcomes, especially for moderate and high~     risk abdominal surgical patients. A novel closed-loop fluid administration system based on~     multi-parameter hemodynamic monitoring have been described recently. This prospective,~     randomized, surgeon and patient blinded study aims at comparing the cardiac output provided~     by either this closed-loop system or the anesthesiologist team in high-rish surgical patient~     elected for abdominal surgery at Pierre Bénite University Hospital, Hospices Civils of Lyon,~     France. Primary endpoint is the mean indexed cardiac output during surgery per group. We will~     also compare hemodynamic parameter (cardiac output, stroke volume, blood pressure heart~     rate…) and patient's outcomes (morbidity, mortality, transfusion rate, hospital length of~     stay) between groups~   "
123509|NCT01950832|"~     To evaluate the macular, retinal nerve fiber layer (RNFL) and choroidal thickness alterations~     by using spectral-domain optical coherence tomography (SD-OCT) in polycystic ovary syndrome~     (PCOS) and to compare them with healthy reproductive-age women controls.~   "
123510|NCT01950819|"~     This is a 2-year, randomized, multicenter, open-label, 2-arm study evaluating the graft~     function of everolimus and reduced CNI versus MPA and standard CNI in adult de novo renal~     transplant recipients.~   "
123511|NCT01950806|"~     The objective of this randomized, controlled feeding study is to investigate the potential~     health benefits of a pecan-containing diet. The investigators hypothesize the chronic~     consumption of pecans will improve an array of biomarkers related to cardiovascular disease~     and type 2 diabetes risk, including indices of oxidative stress, antioxidant activity,~     inflammation, endothelial function, and insulin resistance when compared with a control diet~     that is absent nuts.~   "
123512|NCT01950793|"~     The study is to compare the effect between steroid injection and Hyaluronic acid in treatment~     trigger finger. Using sonoguided injection technique achieves more accurate injection~     location and therapeutic effect. We hypothesize hyaluronic acid has both lubricant and~     anti-inflammation effect in treatment of trigger finger, and can provide better outcome and~     lower adverse effect than steroid injection.~   "
123513|NCT01950780|"~     Alopecia areata (AA) is a common disease of the immune system, known as an autoimmune~     disease. In the disease, the immune system mistakenly destroys the hair follicle, causing~     hair to fall out. Despite many people having this disease, research into its cause and into~     new, better ways to treat AA has lagged far behind other similar diseases of the immune~     system. Currently, there are no Federal Drug Administration approved drugs for AA.~      Ruxolitinib (made by Incyte) is an intervention known to effectively treat a disease of the~     bone marrow, known as myelofibrosis. It is also being studied in the treatment of rheumatoid~     arthritis, another autoimmune disease, by fighting inflammation. There are some genetic and~     chemical similarities between those with myelofibrosis, active rheumatoid arthritis and AA,~     suggesting that treatment with ruxolitinib may be effective in AA. In mice specially designed~     for testing drugs for the treatment of human alopecia areata, this medication worked to~     prevent the disease AA from starting in mice that would have otherwise developed the disease.~     To test Ruxolitinib, we are going to treat 12 patients with moderate to severe AA for a~     minimum of 3 months up to 6 months. This is an open-label study, meaning that there will~     not be a placebo group; all patients enrolled in the study will receive the active~     medication. The effectiveness of the medication will be measured by changes in hair re-growth~     as determined by physical exam and photography, as well as by patient and physician scoring.~     Patients will be followed for another 3 months off of the drug to see if the effects of~     treatment last and if there is delayed response. The safety of the medication, ruxolitinib,~     in patients with alopecia areata will also be evaluated.~      Blood work will be collected before medication is started, during the treatment period, and~     after ruxolitinib is stopped, in order to monitor for adverse effects of the medication.~     Small scalp biopsies and peripheral blood will be taken at the beginning of the study before~     treatment and also after 12 and possibly 24 weeks. Optional biopsies may also be taken at~     additional time points based on clinical considerations. The chemical analysis of these skin~     samples and blood will help us to understand how the disease happens, how the treatment~     works, and may even guide us to better treatments in the future.~   "
123514|NCT01950754|"~     This study could contribute to understanding the aggravation of balance disorders and the~     increased risk of falling in depressive people. It could, among other things, shed light on~     the impact of treatments with antidepressants on balance in treated depressive patients.~     Finally, it could contribute to improving the sensory-motor management of patients with a~     depressive syndrome.~   "
123515|NCT01950741|"~     Effects of VEGF Trap-Eye (aflibercept) in treatment-naive polypoidal choroidal vasculopathy~     (PCV) will be evaluated.~   "
123516|NCT01950728|"~     The objective of this study is to compare the hypoalgesic effects of TENS, Interferential~     current and Aussie current in pressure pain threshold and sensory discomfort in healthy~     subjects.~   "
123517|NCT01950715|"~     Sacral nerve stimulation (SNS) has become a well-established treatment for patients with~     fecal incontinence since 1995. The mechanism of action of SNS is still not fully understood~     but recent studies have shown changes in both colonic motility and rectal sensibility. The~     investigators have previously shown IBS patients to benefit from sacral nerves stimulation.~     With the present study, the investigators aim to evaluate if sacral nerve stimulation alters~     the gastro-colic response in IBS patients.~   "
123518|NCT01950702|"~     To evaluate the success rate for intubation of laryngocope assisted lightwand intubation.~   "
123519|NCT01950689|"~     The purpose of this study is to see whether adding Nimorazole to standard radiotherapy~     benefits patients with locally advanced head and neck squamous cell carcinoma.~   "
123520|NCT01950676|"~     The primary aim of this study is to investigate the feasibility of using a patient-centered~     smart phone application for insulin self-titration on glycemic control. Over a 18-month~     period, suboptimally controlled type 2 diabetes mellitus (T2DM) on oral antidiabetic agents,~     thus requiring insulin treatment patients, will be recruited from the Singapore General~     Hospital (SGH). Patients randomized to the intervention group will be instructed to~     self-adjust their insulin dose using a smart phone application designed to guide~     self-titration; patients randomized to the control group will receive the usual clinical~     care. The primary outcome measure is change in glycated hemoglobin level (HbA1c), 6 months~     post-enrollment. The investigators hypothesize that using a smart phone application for~     insulin self-titration is effective in improving glycemic control in T2DM patients compared~     with usual care.~   "
123521|NCT01950663|"~     RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy.~     The purpose of this study is to calibrate RETeval, and then measure its ability to detect~     vision threatening diabetic retinopathy. Early Treatment Diabetic Retinopathy Study (ETDRS)~     7-field, dilated, stereo, color fundus photography, read according to the ETDRS protocol,~     will be used as the gold standard.~   "
123522|NCT01950650|"~     This study is conducted in Asia, Europe and in the United States of America. The aim of this~     study is to examine patient and physician beliefs regarding insulin therapy and the degree to~     which patients adhere to their insulin regimens.~   "
123523|NCT01950637|"~     This study is conducted Asia, Europe and North America. The aim of this study is to describe~     insulin therapy adherence and the burden of non-adherence on patient functioning, well-being~     and diabetes management.~   "
123524|NCT01950624|"~     Objective: The development of a patient registry for Down syndrome (DS) was identified as a~     priority in the 2007 Down Syndrome Research Plan. Under the auspices of the Down Syndrome~     Consortium, founded in 2011 as a public-private partnership between the NIH and DS advocacy~     organizations, NICHD awarded a contract in 2012 to create a patient-focused online registry~     to facilitate research participation by individuals with DS. Two advisory boards, composed of~     advocates, family members, clinicians, researchers, and other relevant parties, have been~     involved in the development of the registry materials.~      Study Population: Individuals with DS (including those with mosaic DS and partial trisomy 21)~      Design: DS-Connect (TM) is an online survey tool designed to collect demographic data and~     health information from individuals with DS.~      Outcome measures: The purposes of DS-Connect (TM) are:~        1. To identify the various phenotypic manifestations of DS.~        2. To identify individuals with DS who may be eligible for research studies or new clinical~          trials, based on specific information about their diagnosis and health history.~   "
123525|NCT01950611|"~     The clinical outcome of relapsed acute promyelocytic leukemia (APL) is poor with current~     standard of care approaches. Additionally, standard of care warrants an autologous stem cell~     transplant to be done once molecular remission is achieved. Unfortunately, the majority of~     our patients cannot afford this procedure. We have previously reported the clinical outcome~     of relapsed patients who were managed without a stem cell transplants and showed that the~     event free survival at 5 years is less than 35%. Pre-clinical data reported from our~     laboratory demonstrates that there is significant synergy between arsenic trioxide (ATO;~     which is the accepted standard of care agent for relapsed APL) and Bortezomib (a proteasome~     inhibitor). We have evaluated this combination extensively in-vitro and this data was~     accepted as an oral presentation at the American Society of Hematology (ASH) meeting in 2011.~     More recently we have also reported the potential mechanism for this synergy (Poster at ASH~     2012). We also have mouse model data which supports these findings. We plan to move this~     combination of ATO based therapy combined with Bortezomib to a Phase II clinical trial to~     validate these observations. The anticipated potential is that we will have a combination~     therapy that is less expensive, cost effective and safe with comparable clinical outcomes to~     those treated with the more expensive standard of care which includes an autologous stem cell~     transplant and which the majority of our patients cannot afford.~   "
123526|NCT01950598|"~     The purpose of this study is to determine whether frozen corneas are as safe and effective as~     fresh corneas for use as carriers with the Boston Keratoprosthesis type I (KPro) over long~     term follow-up.~      Corneal transplantation is typically performed using fresh, transparent corneas. With KPro~     surgery, the corneal transplant only serves as a carrier to suture the KPro in place. The~     cornea used in KPro surgery does not need to be clear like a normal transplant. Frozen~     corneal tissue can be used to repair the cornea in cases of emergency but the tissue is not~     transparent and does not allow good vision. We hypothesize that frozen grafts are equivalent~     as fresh grafts when used as carrier for the KPro.~   "
123527|NCT01950585|"~     Pulmonary arterial hypertension (PAH) is a serious and eventually fatal disease damaging the~     lungs and the heart. It results from narrowing and eventual blockage of small blood vessels~     in the lung, due to abnormal proliferation of cells in the blood vessel (arterial). Patients~     with PAH suffer from fatigue, shortness of breath, low oxygen levels, blood clots and heart~     failure. No therapies reverse the disease process in the lung arteries, however there are~     three approved drugs that can temporarily dilate the vessels and improve symptoms. However,~     all three drugs have significant side effects and toxicities, they do not work effectively in~     many patients, survival remains on average only 2 to 3 years once symptoms begin, and none of~     these drugs prevent the underlying disease process in the small arteries of the lung.~      PAH is known to develop in patients with a pre-existing class of bone marrow diseases called~     myeloproliferative disorders (MPDs). We and others have recently shown that patients with PAH~     have bone marrow changes similar to those seen in patients with MPDs, even without other~     signs and symptoms of those bone marrow diseases such as anemia or high platelet and white~     blood cell counts. Compared to healthy volunteers, patients with PAH have a higher frequency~     of immature stem and progenitor cells able to produce blood cells and vascular wall cells in~     their bone marrow. They also have higher circulating numbers of these cells in the blood, and~     increased localization of these cells in the lung blood vessels. When immature bone marrow~     cells from PAH patients and normal volunteers were infused into mice, the mice receiving PAH~     marrow cells developed similar lung and heart problems to PAH patients, suggesting that the~     bone marrow problem is a primary cause of the lung problems, and that the increased numbers~     of immature bone marrow cells in the bone marrow and blood of PAH patients causes the lung~     blood vessel disease.~      The drug hydroxyurea is used to inhibit the abnormally high level of bone marrow cell~     proliferation in patients with MPDs. It has been shown to reduce the numbers of circulating~     immature bone marrow cells in patients with MPDs. Hydroxyurea has been available for almost~     fifty years, and has been used to treat patients with MPDs, sickle cell anemia, and~     congenital heart disease for very prolonged periods of time, up to twenty or more years in~     individual patients. It has an excellent long-term safety profile and few side effects and is~     generally well tolerated. It does not appear to result in an increased rate of leukemia even~     with many years of treatment.~      In the current protocol, we hypothesize that treating patients with PAH with hydroxyurea will~     decrease the level of circulating immature bone marrow cells and interrupt the abnormal~     narrowing and occlusion of lung arteries. We will treat patients with moderately severe~     primary (no known underlying cause) PAH with 6 months of hydroxyurea, carefully monitoring~     side effects and adjusting dosage as necessary, and measure the effect on circulating~     immature cells, lung blood vessel pressures, other blood markers of active PAH, and exercise~     tolerance.~   "
123528|NCT01950572|"~     Background:~        -  Malignant mesothelioma is a malignancy arising from the mesothelial cells of the pleura,~          peritoneum, pericardium, or tunica vaginalis.~        -  Mesothelioma accounts for 0.10% of deaths annually in the United States. Malignant~          pleural mesothelioma is the most common of these, comprising of 80% of the cases with an~          annual incidence of about 2,500 in the United States.~        -  The median survival from diagnosis of pleural mesothelioma is approximately 12 months.~          The majority of patients present with stage III or IV disease with 85-90% of patients~          considered unresectable at diagnosis.~        -  Peritoneal mesothelioma has a better prognosis than pleural mesothelioma; nevertheless,~          patients undergoing therapy for peritoneal mesothelioma have few well-studied treatment~          options due in large part to the rarity of the disease.~      Objectives:~      -To allow sample acquisition for use in the study of mesothelioma.~      Eligibility:~        -  All patients age greater than or equal to 2 years with malignant mesothelioma~        -  Must be able and willing to provide informed consent if 18 or over; parent or guardian~          must be able and willing to provide consent for patients under the age of 18~      Design:~        -  Up to 1000 subjects will be enrolled.~        -  Patients will be followed to determine the course of disease and to record any treatment~          received for mesothelioma.~        -  Patients will undergo sampling of blood, urine, tumor and abnormal body fluids for~          tissue banking.~        -  Studies which may be performed on banked material include genetic and genomic studies,~          establishment of cell cultures and immunologic studies.~   "
123529|NCT01950559|"~     Food allergy is on the rise within the pediatric population. Having a food allergy can cause~     medical, nutritional and psychological issues in those who suffer with it. Although making~     the appropriate diagnosis of food allergy is very important, properly diagnosing food allergy~     has been a challenge. Skin prick testing and food-specific IgE testing of the blood can give~     positive results that are false. Currently, Oral Food Challenges are the best way to diagnose~     a food allergy. Unfortunately, Oral Food Challenges are time consuming and may not be readily~     available to suspected food allergy sufferers. This study is designed to examine the~     effectiveness of an allergy-detecting blood test called ImmunoCAP manufactured by the~     company, ThermoFisher.~      Soybean is one of the eight allergy-inducing foods that are responsible for 90% of all food~     allergies. A part of the study is to allow the study Sponsor to use some of the blood sample~     collected from you to test if genetically-changed soy has more or less allergy producing~     factors. This is important to the Sponsor to test the safety of their genetically modified~     soy.~   "
123530|NCT01950546|"~     This study aims to evaluate the effectiveness of nanosilver fluoride for controlling the~     growth of S. mutans present in dental plaque of children.~   "
127444|NCT01899261|"~     This pilot clinical trial studies stereotactic body radiation therapy in treating patients~     with liver cancer that cannot be removed by surgery. Stereotactic radiation therapy may be~     able to send x-rays directly to the tumor and cause less damage to normal tissue.~   "
123531|NCT01950533|"~     Food allergy is on the rise within the pediatric population. Having food allergy can cause~     medical, nutritional and psychological issues in those who suffer with it. Although making~     the appropriate diagnosis of food allergy is very important, properly diagnosing food allergy~     has been a challenge. Skin prick testing and food-specific IgE testing of the blood can give~     positive results that are false. Currently, Oral Food Challenges are the best way to diagnose~     a food allergy. Unfortunately, Oral Food Challenges are time consuming and may not be readily~     available to suspected food allergy sufferers. This study is designed to examine the~     effectiveness of an allergy-detecting blood test called IMMULITE 2000 manufactured by the~     study sponsor, Siemens.~   "
123532|NCT01950520|"~     Background:~      - Changes in how a person s body burns energy or calories can affect their weight over time.~     The lowest level of energy the body needs to function is called basal metabolic rate. In the~     cold, we burn extra energy, even before we start to shiver. This is called non-shivering~     thermogenesis and it occurs in different types of tissue such as muscle and fat. Researchers~     want to learn more about this type of energy burning and how it is regulated. They hope this~     will help treat obesity in the future.~      Objectives:~        -  Sub-study 1: to better understand how non-shivering thermogenesis works.~        -  Sub-study 2: to measure the effects of anti-obesity drugs on basal metabolic rate.~        -  Sub-study 3: to better understand the effects of mirabegron, a beta-3 adrenergic~          receptor agonist, on brown fat activity.~      Eligibility:~      - Healthy, lean adult males ages 18 to 35.~      Design:~        -  Participants will be screened with medical history, physical exam, blood test, and EKG.~        -  For sub-studies 1 and 2:~             -  Participants will receive one X-ray scan.~             -  Each day, all participants will:~      <TAB>- Have height and weight measured, and have urine collected.~        -  Spend 4 hours in a temperature-controlled room with furniture, toilet area, phone, and~          computer. They will wear small non-invasive devices to monitor activity, heart rate,~          temperature, and shivering.~      <TAB>- Walk for 30 minutes.~      -For sub-study 3:~        -  Participants will receive one DXA scan and up to 4 PET/CT scans and 4 MRIs~        -  Each stay, all participants will:~      <TAB>- Have height and weight measured, and have urine collected.~        -  Spend 6 hours in a temperature-controlled room with furniture, toilet area, phone, and~          computer. They will wear small non-invasive devices to monitor activity, heart rate,~          temperature, and shivering.~        -  Participants will be compensated for their time and participation at the end of the~          study~   "
123533|NCT01950507|"~     Background:~      The gastrointestinal (GI) tract is commonly affected by acute graft-versus-host disease~     (aGVHD) and chronic GVHD (cGVHD) in patients who have undergone blood or marrow stem cell~     transplantation (BMT). Initially, patients are treated with systemic corticosteroids, which~     produce complete response rates in 35 percent. Although short courses of steroids are~     preferred to minimize adverse effects, many patients require systemic treatment chronically~     since GI GVHD can negatively impact quality of life and nutrition status. One option to~     minimize systemic steroid exposure is by nonabsorbable corticosteroids that act locally on~     the GI tract.~      Budesonide (Entocort EC, AstraZeneca, Wilmington, DE) is an FDA-approved oral topical~     corticosteroid for the treatment of mild to moderate active Crohn s disease involving the~     ileum and/or the ascending colon, and for maintenance of clinical remission of mild to~     moderate Crohn s disease involving the ileum and/or the ascending colon for up to 3 months.~     It has a high ratio of topical-to-systemic activity with minimally active metabolites, and~     undergoes extensive first-pass metabolism. Since both intestinal GVHD and Crohn s disease~     seem to share a similar pathogenic background, budesonide has been used in the BMT setting~     for GI GVHD, usually in combination with systemic corticosteroids (e.g. methylprednisolone)~     to improve clinical response and allow for more rapid tapering of systemic corticosteroid~     doses.~      First-pass metabolism is mediated mostly by the cytochrome P450 (CYP450) enzyme system. The~     liver is the major site of CYP450-mediated metabolism but the enterocytes of the intestinal~     epithelium are also an important site for drug metabolism. Budesonide undergoes significant~     metabolism by CYP enzymes with substantial first-pass metabolism. The potential for greater~     systemic availability of orally administered budesonide exists when it is given concurrently~     with triazole antifungals, which are commonly prescribed for prophylaxis or treatment of~     fungal infections after transplantation. Fluconazole and voriconazole are moderate and strong~     inhibitors of CYP3A4, respectively, and budesonide is a CYP3A4 substrate. Inhibition of~     CYP3A4 may impair the metabolism of budesonide, resulting in systemic concentrations of~     budesonide and subsequently, adverse effects such as hyperglycemia. If the presence of~     fluconazole or voriconazole does impair budesonide s metabolism, then dose adjustments to~     budesonide may be warranted.~      There are no prospective studies evaluating the effects of fluconazole or voriconazole on~     budesonide s pharmacokinetics in patients who have undergone BMT.~      The primary objective of the proposed study is to determine the effects of fluconazole and~     voriconazole on the trough (Cmin) and peak (Cmax) of budesonide in patients who have~     undergone BMT and who have GI GVHD.~      The primary endpoints are the Cmin and Cmax of budesonide. Secondary endpoints include the~     Cmin of voriconazole.~      Objectives:~      The proposed study seeks to determine the effects of fluconazole and voriconazole on the~     Cminand Cmax of budesonide.~      Eligibility:~      Adult and pediatric subjects (greater than or equal to 13 years of age and greater than or~     equal to 49 kg) who are registered to an NCI or NHLBI protocol who have undergone a bone~     marrow, cord, haplo-cord or peripheral blood stem cell transplantation who have GI GVHD as~     determined by the medical team and who require treatment with budesonide and are candidates~     for antifungal therapy are eligible for this study.~      Design:~      Each subject will serve as his or her own control to minimize the variation in absorption,~     distribution, metabolism and elimination of oral budesonide that can occur from subject to~     subject, due to genetic, anatomic or other unidentified differences. For example, genetic~     polymorphisms of CYP2C19, which is significantly involved in voriconazole s metabolism, could~     otherwise affect the results of the study (i.e. CYP2C19 poor metabolizers may experience~     higher voriconazole serum concentrations, which could results in greater CYP3A4 inhibition~     and higher budesonide exposure). In addition, the longitudinal cohort design of this study~     will be able to answer the research questions posed with fewer research subjects. Research~     subjects will be accrued into one of three cohorts depending on the antifungal prophylaxis~     (or lack thereof) the subject is receiving at study entry and the preference of the medical~     team for continued antifungal coverage after the initiation of budesonide and systemic~     corticosteroids. Subjects who are not currently receiving antifungal prophylaxis or who are~     on fluconazole at baseline are eligible for enrollment in Cohort 1. Subjects in Cohorts 2 and~     3 are receiving voriconazole and fluconazole at study entry, respectively. In Cohort 1, if~     applicable, subjects will stop fluconazole on day -1...~   "
123534|NCT01950494|"~     Hand dermatitis, (a rash, or eczema, on the hands) is a common skin condition that affects~     approximately 10% of the population. It can be caused by a wide variety of things, such as~     allergens or irritants. For some, it can be painful and disfiguring. In moderate to severe~     cases, hand dermatitis can interfere greatly in the quality of life of the affected person,~     interfering with work and social functions. This can have a negative psychological effect as~     well.~      FiteBac Skin Care Gel is a new over-the-counter hand sanitizer that has been used for~     hospital and dental hand infection control. This product contains a germicide, to prevent~     infection. It also contains a silicone polymer. This makes the hand gel more durable, causing~     it to remain on the skin longer. Despite this durability, the hand gel still allows the skin~     to naturally perspire (sweat).~      As people in the health-care industry have used this new product with the goal of reducing~     hand infections, it has been noted that FiteBac Skin Care Gel also seems to have reduced hand~     dermatitis and improved personal skin condition. The purpose of this study is to~     scientifically measure skin improvement in a population of study subjects with hand~     dermatitis.~   "
123535|NCT01950481|"~     Pharmacokinetics and safety of 750 mg of LDK378 given once orally in subjects with impaired~     hepatic function and healthy subjects with normal hepatic function.~   "
123536|NCT01950468|"~     This is a phase 3, open-label, multiple-center, randomized cross-over study to assess the~     safety and efficacy of [123I]NAV5001 SPECT imaging in aiding in the differentiaion of~     parkinsonian syndromes from non-parkinsonian tremor.~   "
123537|NCT01950455|"~     This is a phase 3, open-label, multiple-center, non-randomized single dose study to assess~     the safety and efficacy of [123I]NAV5001 SPECT imaging in aiding in the differentiaion of~     parkinsonian syndromes from non-parkinsonian tremor.~   "
123538|NCT01950442|"~     Despite improvement in treatment-related morbidity and mortality, esophageal cancer is still~     one of the most lethal malignancies. Accurate staging is essential to establish prognosis and~     for patient management. Staging helps to determine if surgery, chemotherapy, radiation~     therapy, a combination of these, or a palliative approach is the most appropriate.~      Endoscopic ultrasound techniques are becoming more and more popular. At Notre Dame Hospital,~     Centre Hospitalier de L'Universite de Montreal, all patients diagnosed with esophageal cancer~     undergo complete EUS staging. In selected patients, EUS is followed by EBUS during the same~     procedure, in order to examine all the lymph nodes near or far from the primary tumor~     amenable to EBUS guided trans-bronchial biopsy. In patients with a malignant esophageal~     stricture, we have preformed very gentle balloon dilation up to 14 mm. It is important to~     realize that this is not to achieve symptom resolution, but rather to allow the passage of~     the scope. We hypothesize that earlier reports of higher perforation rates were related to~     unnecessary aggressive dilation. Thus far, we have successfully dilated over 60 patients~     during the last four years (2009-2013) and were able to pass the scope and complete the~     examination in the vast majority of patients with no morbidity.~   "
123539|NCT01950429|"~     Background:~      - Sickle cell disease changes the shape of red cells. This makes them more likely to break~     down as they get stuck in small blood vessels. This leads to low red cell count and also~     damage to small blood vessels that supply many organs. One of the affected organs is the~     liver. Sickle cell disease and its treatment through blood transfusion can lead to~     significant liver damage. This disease also can cause the liver to regrow abnormally after~     damage. This can cause high blood pressure in the liver. Researchers want to know if curing~     sickle cell disease with a stem cell transplant improves liver damage.~      Objectives:~      - To explore specific factors that improve or worsen sickle cell liver disease after a stem~     cell transplant.~      Eligibility:~      - Adults ages 18 and older with sickle cell liver disease.~      Design:~        -  Participation will take approximately 7 days over 2 years.~        -  Visit 1: participants will be screened with medical history and review of current~          treatment regimen.~        -  Visit 2: participants will return to the clinic for explanation of the study and~          physical exam. They will also have blood and urine tests, and scans of the liver.~        -  All participants will have a 2-night stay at the clinic. They will have a liver biopsy~          and a test of liver pressure. They will be sedated and a tube will be inserted in a vein~          in their neck.~        -  Participants who have a stem cell transplant will have a second biopsy about 24 months~          later.~        -  Over the 2-year study period, participants will have blood drawn 2-4 times and stool~          samples collected 2 times.~   "
123549|NCT01950299|"~     VCU-ART3 is a double-blind randomized clinical trial of anakinra high dose vs anakinra~     standard dose vs placebo in patients with ST-segment elevation myocardial infarction (STEMI)~     measuring the effects on the acute rise and fall of the plasma C reactive protein levels~     during the first 14 days.~   "
123540|NCT01950416|"~     This is a two-center, prospective, randomized, single-blind, investigator initiated,~     pharmacodynamic study of parallel design, carried out in 2 PCI-capable cardiology centers~     (Patras University Hospital and Konstantopoulio General Hospital of Athens).~      Patients with ST elevation myocardial infarction, having undergone fibrinolysis in the~     previous 3 to 48 hours, who present high residual PR (defined as PRU ≥208 ) on admission, pre~     coronary angiography, will be randomized after written informed consent, in a 1:1 ratio to~     either:~      Ticagrelor 180mg loading dose (LD), followed by a 90mg x2 maintenance dose (MD) starting 12±6~     hours post LD, until discharge.~      Or~      Clopidogrel 600mg loading dose (LD), followed by a 150mg once daily maintenance dose (MD)~     starting 12±6 hours post LD, until discharge.~      Platelet reactivity assessment will be performed at randomization (Hour 0) and at 2, 24 hours~     after randomization, as well as pre-discharge, using the VerifyNow assay, in platelet~     reactivity units (PRU).~      Documentation of major adverse cardiac events (death, myocardial infarction, stroke, ischemia~     driven revascularization procedure with PCI or CABG) and bleeding (according to BARC~     criteria) will be performed until patient's discharge.~   "
123541|NCT01950403|"~     This randomized phase I trial studies the side effects and best dose of linaclotide acetate~     in preventing colorectal cancer in healthy volunteers. Chemoprevention is the use of certain~     drugs to keep cancer from forming. The use of linaclotide acetate may prevent colorectal~     cancer.~   "
123542|NCT01950390|"~     This randomized phase II trial studies how well ipilimumab with or without bevacizumab works~     in treating patients with stage III-IV melanoma that cannot be removed by surgery. Monoclonal~     antibodies, such as ipilimumab and bevacizumab, block tumor growth in different ways by~     targeting certain cells.~   "
123543|NCT01950377|"~     Background:~      - Previous research has shown that dopamine, a brain chemical, is involved in decision~     making. Different genes influence how much dopamine people have in their brains and how that~     affects their behavior. Researchers will study if genes associated with dopamine affect~     decision making and impulsiveness. All participants will take tests; some will have brain~     images taken. Researchers will study the test responses and images; they will look for how~     differences in these genes affect different types of decision making.~      Objectives:~      - To see if genes involved in a brain chemical, dopamine, are related to impulsiveness on~     behavioral tests.~      Eligibility:~      - Healthy adults ages 18 to 55.~      Design:~        -  Participants will be screened with a medical history and physical exam.~        -  All participants in this study will have at least 1 outpatient visit to the NIH Clinical~          Center. Each visit will last 2 4 hours. At the first visit:~        -  A blood sample will be taken only from participants that have not been previously~          enrolled in 95-M-0150~        -  Participants will be given tests of their memory, attention, concentration, and~          thinking.~        -  Some participants will have a second visit. It will be scheduled as soon as possible~          after the first. At the second visit:~        -  Participants will have an MRI (magnetic resonance imaging). They will have to lie in a~          scanner for up to 2 hours. The MRI uses magnets, radio waves, and computers to produce~          detailed pictures of the brain.~        -  Participants will repeat the tests from the first visit. Some will be done during the~          MRI.~   "
123544|NCT01950364|"~     This is an open-label trial to estimate the concentrations of brentuximab vedotin in~     relapsed/refractory Hodgkin lymphoma (HL) or relapsed/refractory systemic anaplastic large~     cell lymphoma (sALCL) participants treated with either brentuximab vedotin or brentuximab~     vedotin + rifampicin.~   "
123545|NCT01950351|"~     The goal of this clinical research study is to learn if delivering proton therapy in higher~     doses per treatment may help control prostate cancer just as well as the standard of care~     treatment. The safety of this treatment will also be studied.~      Radiation dose is measured in units called Gray (Gy). The standard of care treatment schedule~     for proton therapy is 1.8-2 Gy, given 1 time per day, 5 days per week over a period of 8-9~     weeks.~   "
123546|NCT01950338|"~     Stroke is the leading cause of physical disability, particularly due to the presence of~     spasticity. Different needling techniques, including the use of Botulinum Toxin A are~     proposed for the management of spasticity. The presence of spasticity in the lower extremity~     implies several impairments for standing and walking inducing high disability. No study has~     investigated the effects of deep dry needling inserted into the targeted spastic musculature~     in patients with stroke. The investigators will conduct a randomized controlled trial~     investigating the effects of a single session of deep dry needling over the musculature of~     the leg on spasticity, widespread pressure pain sensitivity and plantar pressures~     (baropodometry) in individuals with chronic stroke. The investigators hypothesize that~     patients receiving a single session of dry needling would exhibit a greater reduction in~     spasticity and pressure sensitivity than those who will not receive the intervention.~   "
123547|NCT01950325|"~     This is the first clinical trial of the VRC-HIVMAB060-00-AB (VRC01) monoclonal antibody.~     VRC01 is a broadly neutralizing antibody directed against HIV. This is a dose-escalation~     study to examine safety, tolerability, dose and pharmacokinetics of VRC01. The hypothesis is~     that VRC01 will be safe for administration to HIV-1 infected adults by the intravenous (IV)~     and subcutaneous (SC) routes and will not elicit hypersensitivity reactions. Samples will be~     collected to learn if VRC01 is detectable in mucosal secretions and blood of participants and~     how long VRC01 can be detected in the blood after it is given.~      Between 15 and 25 HIV-1 infected adults, ages 18-70 years will be enrolled. There are 4 dose~     escalation groups for IV administration; the doses are 1 mg/kg, 5 mg/kg, 20 mg/kg and 40~     mg/kg. There is 1 group for SC administration at 5 mg/kg. Each group is expected to include~     at least 3 participants. Each participant will receive two infusions of VRC01 with about 1~     month between doses. Infusions are administered in an inpatient unit and an overnight stay at~     the NIH Clinical Center is required. No more than one subject per day per group will receive~     a first infusion of the VRC01 product by the IV route and no more than one subject per week~     will receive a first infusion of the product by the SC route. Study participation lasts for~     24 weeks. Participant health and effect on CD4 count and HIV viral load will be monitored.~     Samples will be collected and stored for research purposes.~   "
123548|NCT01950312|"~     The purpose of this study is to determine if gevokizumab therapy may be an alternate therapy~     in patients with steroid resistant Autoimmune Inner Ear Disease.~   "
127445|NCT01899248|"~     The purpose of this study is to assess the effects of inhalation agent on corrected QT~     interval duration during liver transplantation.~   "
123550|NCT01950286|"~     Hyper-CVAD (a chemotherapy regimen) has shown promising results in adult T-cell Acute~     Lymphoblastic Leukemia (T-ALL). Patients with T-ALL diagnosis were reported to the Swedish~     Adult Acute Leukemia Registry between October 2002 and September 2006. Hyper-CVAD was~     recommended to all patients without severe comorbidity. Allogeneic stem cell transplantation~     was recommended for patients with high-risk disease. The aim of this population-based study~     was to assess the efficacy of Hyper-CVAD treatment.~   "
123551|NCT01950273|"~     The primary objective of the study is to assess the pharmacokinetic (PK) similarity of~     Boehringer Ingelheim (BI) 695500 vs. rituximab (MabThera®) in previously untreated patients~     with low tumor burden follicular lymphoma (LTBFL).~      The secondary objective of the study is to evaluate the pharmacodynamics (PD), safety, and~     anti-tumor activity of BI 695500 vs. rituximab (MabThera®), as well as the presence of~     anti-drug antibodies (ADAs).~   "
123552|NCT01950260|"~     The study will try to answer the question of whether early treatment with levothyroxine at 4~     weeks after radioactive iodine for Graves'disease will prevent overt hypothyroidism (low~     thyroid hormone levels).~   "
123553|NCT01950247|"~     The main objective of this study is to compare the safety, effect on quality of life, and~     resource utilization of Injectafer vs. intravenous (IV) iron standard of care (SOC) for the~     treatment of iron deficiency anemia (IDA) in an infusion center setting. The study will also~     assess the ability of baseline serum hepcidin levels to predict if subjects will have a~     clinically meaningful hemoglobin response to oral iron therapy or to IV iron therapy.~   "
123554|NCT01950234|"~     This is a phase II, randomized, double-blind, placebo-controlled, multi-center study to~     evaluate the safety, tolerability, and efficacy of adrenocorticotropic hormone (ACTH, Acthar~     gel) administered as a pulsed regimen consisting of injections on three consecutive days per~     month in patients with progressive forms of Multiple Sclerosis (MS). Patients will be~     randomly assigned to either an ACTH arm or a placebo arm. The main hypotheses are that 1)~     pulsed ACTH will be safe and well-tolerated, and 2) pulsed ACTH will slow progression of~     clinical and paraclinical measures of MS progression compared to placebo.~   "
123555|NCT01950221|"~     This project is designed to study whether pomegranate extract benefits cognitive abilities in~     middle-aged and older non-demented volunteers. Subjects will be randomly assigned to one of~     two treatment groups: either a placebo or the pomegranate extract supplement. Both the~     placebo and pomegranate extract will be packaged in 1000 milligram capsules to maintain~     blindness. Subjects will take one 1000 milligram capsule daily for twelve months.~      The investigators expect the people receiving the pomegranate extract supplement to show~     better cognitive performance compared with those receiving a placebo after one, six, and~     twelve months. The investigators believe cognitive decline and treatment response will vary~     according to a genetic risk for Alzheimer's.~      The investigators will study 212 non-demented subjects aged 50-75 years. Initially, subjects~     will undergo a clinical assessment, an MRI and a blood draw to determine genetic risk and to~     rule out other neurodegenerative disorders linked to memory complaints.~      Subsequently, subjects will undergo the first memory (or neuropsychological) assessments.~     Following the first assessment, subjects will begin taking the supplement (either the~     pomegranate extract or the placebo). Subjects will undergo a brief memory test at one-month~     mark. At six months, subjects will have a second, full neuropsychological assessment. The~     final assessment will take place at the end of the study, the 12-month mark. Additional blood~     will be drawn at baseline and at 12 months and frozen to assess inflammatory markers if~     outcomes are positive. Subjects will also be asked to come to the University of California,~     Los Angeles (UCLA) at 3 and 9 months for supplement refills.~      In total, subjects will be expected to come to UCLA for 7 visits during the course of 12-13~     months.~   "
123556|NCT01950208|"~     the purpose of this study is to develop and validate a new PRO measurement tool for the knee~     joint, the so-called Munich Knee Questionnaire (MKQ), allowing for a qualitative~     self-assessment of the Knee Injury and Osteoarthritis Outcome Score (KOOS), the International~     Knee Documentation Committee (IKDC), the Lysholm Knee Score, the Western Ontario Meniscal~     Evaluation Tool (WOMET) and the Tegner Score.~   "
123557|NCT01950195|"~     This research is being done to look at the safety of using stereotactic radiosurgery (SRS)~     and Ipilimumab together to treat melanoma that has spread to the brain or spine. Both~     Ipilimumab and SRS are used alone for the treatment of melanoma that has spread. Standard of~     care uses both of these treatments but not together. By using them together, we expect better~     treatment of melanoma, but there might be an increase in side effects.~      Ipilimumab is approved by the Food and Drug Administration (FDA) for the treatment of~     melanoma that has spread throughout the body. It works by activating your immune system to~     fight off cancer.~      Stereotactic radiosurgery (SRS) is approved by the Food and Drug Administration (FDA) for~     the treatment of melanoma in the brain or spine. It uses radiation to treat tumors without~     needing to cut or use stitches.~      The use of combining SRS and Ipilimumab in this research study is investigational. The word~     investigational means that this combination is not approved for marketing by the Food and~     Drug Administration but is allowed for use in this research study.~   "
123558|NCT01950182|"~     The primary objective of this study is to compare progression-free survival (PFS) of patients~     with metastatic Luminal B2 breast cancer subtype randomised to treatment with Trastuzumab~     Combined With Chemotherapy or Endocrine Therapy.~   "
123559|NCT01950169|"~     The study hypothesis is that nutritional supplementation together with bisphosphonates have a~     better preserving effect on bone mineral density (BMD) after hip fracture than~     bisphosphonates alone and that nutritional supplementation given postoperatively for 6 months~     preserve lean body mass in elderly hip fracture patients.~   "
123560|NCT01950156|"~     The investigators previously identified three novel HLA-A*2402-restricted epitope peptides,~     which were derived from three cancer-testis antigens, URLC10, CDCA1, and KIF20A, as targets~     for vaccination against lung cancer. In this clinical study, the investigators examine using~     a combination of these three peptides the safety, immunogenicity, and antitumor effect of~     vaccine treatment to prevent relapse of the disease for HLA-A*2402-positive advanced~     non-small cell lung cancer patients whose disease are controlled after any standard~     therapies.~   "
123592|NCT01949740|"~     This pilot research trial studies patient preferences in making treatment decisions in~     patients with stage I-IVA oropharyngeal cancer. Questionnaires that measure patient~     priorities before and after treatment may improve the ability to plan for better quality of~     life in patients with oropharyngeal cancer.~   "
123561|NCT01950143|"~     The biology of prostate cancer is associated with changes in genes and metabolites within~     prostate tissue. There is robust evidence to suggest that a diet rich in broccoli can prevent~     or retard the development of prostate cancer by influencing these changes. This is likely to~     be due to a natural chemical that is obtained in these vegetables known as sulforaphane.~      In this study, we are seeking to provide further evidence that a diet rich in broccoli may~     prevent prostate cancer from developing, and to understand how this may happen. We propose to~     undertake a human intervention study to test the hypothesis that a broccoli-rich diet can~     alter the metabolism and gene expression within prostate tissue of men under active~     surveillance in a manner that would reduce the probability of the emergence and progression~     of aggressive cancerous clones. Participants recruited onto this study will be randomly~     allocated to one of three dietary groups in which they will be required to consume one~     portion per week of a broccoli soup delivering a different concentration of sulforaphane.~     This will be part of their normal diet for one year.~      Blood, urine and prostate biopsy tissue will be obtained before and after a 12 month~     intervention period. Prostate biopsies will be obtained either though transperineal template~     biopsies, a technique accepted as best clinical practice because it provides better sampling~     of the prostate, or transrectal ultrasound guided biopsy which is currently the standard of~     care for obtaining biopsies.~      This study has been funded by Biotechnology and Biological Sciences Research Council (BBSRC)~     and Prostate Cancer foundation (PCF).~   "
123562|NCT01950130|"~     Due to advances and increased practice of interventional therapy for coronary artery disease,~     the rate of high-risk patients with severe coronary disease and reduced left ventricular~     function among patients undergoing coronary artery bypass grafting surgery (CABG) is~     increasing. The perioperative mortality in these patients is ≥ 5%. The perioperative and~     operative management for these patients has to be optimized in order to reduce their~     perioperative morbidity and mortality. One of the central aspects is perioperative~     maintenance of hemodynamic stability. The use of prophylactic IABP is a partly established,~     but not sufficiently evidence-based measure to reduce ventricular afterload and improve~     coronary perfusion pre-, intra- and postoperatively. Yet, it is an invasive procedure with~     potential complications. The planned trial should give an explicit answer, whether~     preoperative prophylactic IABP decreases 30-day all-cause mortality (primary endpoint) and~     long-term mortality (3, 6, 12 months; secondary endpoints) compared to preoperative~     conservative treatment in high-risk patients undergoing CABG.~   "
123563|NCT01950117|"~     Recently, it was reported that the incomplete resection rate of neoplastic large polyps after~     conventional polypectomy was markedly high in clinical practice. The incomplete resection~     rate of neoplastic large polyps after endoscopic mucosal resection (EMR) is not known.~      The aim of this study is to compare the incomplete resection rate of neoplastic large polyps~     after EMR or conventional polypectomy. The EMR technique is preferable to conventional~     polypectomy for the complete resection of the large polyps (>15 mm in diameter)~   "
123564|NCT01950104|"~     Preimplantation genetic diagnosis (PGS) is a technique that allow us to improve the results~     of assisted reproduction techniques through the selection of embryos free of chromosomal~     abnormalities.~      At present, it has not been proved that the usage of PGS really improves the live birth rate~     in IVF cycles. However, it has been stated that the reason of not having better results when~     using PGS is that the methodology applied is not adequate.~      Several authors propose that the optimal methodology for PGS includes the application of~     comparative genomic hybridization (CGH) arrays for genetic testing and carrying out embryo~     biopsy at the blastocyst stage. Nevertheless, most IVF centres still applies the day 3 embryo~     biopsy as a daily routine. Despite this fact, there is a gradual transition towards the usage~     of blastocyst-stage biopsy instead of day 3 biopsy.~      The purpose of this clinical study is analysing the results of the IVF cycles with embryo~     biopsy for PGS. Live birth rates and other parameters as the pregnancy and implantation rates~     together with embryo quality will be analysed and compared between two groups of patients~     undergoing IVF cycles with PGS. In one group the biopsy will be applied in day 3 of the~     embryo development, while in the other group the embryo biopsy will be fulfilled at the~     blastocyst stage.~   "
123565|NCT01950091|"~     Nonspecific low back pain (NLBP) is the diagnosis for 85% of low back pain sufferers with no~     underlying medical cause (e.g., herniated disc, spinal stenosis) that requires physician~     care. Treatment, however, is impractical for many physicians to implement during office~     visits, and there are relatively few providers for NLBP treatment that follow national pain~     control guidelines. This study evaluated the efficacy of an on-line intervention using~     desktop computers or mobile technology to help users self treat NLBP occurrences and to~     engage in activities to decrease future occurences.~   "
123566|NCT01950078|"~     Objective: This study was conducted to explore the possible correlation between some gene~     related to pain sensation and individual basal pain perception and postoperative pain~     intensity in the general population. Methods: Patients receiving elective surgery under~     general anesthesia were recruited into this study. The investigators measured their~     preoperative pressure pain threshold (PPT) and pressure pain tolerance (PTO). Pain intensity~     at rest and movement after the operation was evaluated . And the PCA drug consumption were~     recorded. Also there were healthy college students volunteer be recruited into this study.~     The investigators measured their experimental pain sensitivity including pressure pain~     threshold (PPT) and pressure pain tolerance (PTO), etc. Then genotyping was carried out.~   "
123567|NCT01950065|"~     Evaluate the effectiveness and safety of the iovera device for the temporary reduction in the~     appearance of forehead wrinkles.~   "
123637|NCT01949155|"~     The purpose of this study is to confirm the effectiveness, safety and tolerability of OTO-201~     in the treatment of pediatric subjects with bilateral middle ear effusion who require~     tympanostomy tube placement.~   "
123638|NCT01949142|"~     The purpose of this study is to confirm the effectiveness, safety and tolerability of OTO-201~     in the treatment of pediatric subjects with bilateral middle ear effusion who require~     tympanostomy tube placement.~   "
123716|NCT01948128|"~     This protocol is a randomized, phase 2 window of opportunity trial assessing the biological~     effects of short term oral vitamin D administration on breast cancer clinical and~     translational markers in patients awaiting surgery at the Ottawa Hospital. It takes advantage~     of the current wait times (2-8 weeks) for breast cancer surgery as a window of opportunity~     to rapidly assess biological changes with vitamin D intake.~   "
123568|NCT01950052|"~     This study is a randomised control trial comparing the effects of a pre-operative very low~     calorie diet (VLCD) on wound healing in the morbidly obese patients undergoing bariatric~     surgery.~      The benefits and disadvantages of a very low calorie pre-operative diet are not clear. Some~     centres ask their patients to take a VLCD 2-6 weeks before bariatric surgery with the aim of~     shrinking the liver to make surgery easier. Studies have shown that after this diet the liver~     does shrink and therefore operating may be easier but this did not necessary translate into~     significant lesser operative times. The effects of operating during a catabolic phase have~     not been evaluated. Theoretically a low calorie diet before surgery is similar to starving a~     patient and can potentially create a state of malnutrition. This is rarely advisable before~     surgery and can lead to poor wound healing and poor healing of bowel anastomosis.~      This study will ascertain if there is any difference in wound healing rates in these morbidly~     obese patients (BMI>40kg/m2)undergoing a Laparoscopic Roux en Y gastric by pass in groups who~     have taken the preoperative diet compared to those who were not on a special diet. Skin~     wounds will be evaluated. This will potentially reflect the general state of healing of the~     patient which includes the healing of bowel anastomosis. Surrogate markers will be employed~     to evaluate the pre-morbid nutritional state, effectiveness of dieting, subsequent wound~     healing (collagen production, markers for the different aspects of wound healing) and impact~     on liver cell death .This study will be able to tell us how safe this calorie deficient diet~     is in these morbidly obese patients before surgery.~   "
123569|NCT01950039|"~     Betaine is important in cellular metabolic pathways. Few epidemiologic studies link betaine~     levels to diabetes and cardiovascular disease. Small human studies suggest benefit for~     non-alcoholic liver disease. In this study we will determine if administration of betaine~     improves metabolic measures, liver fat and/or endothelial function in humans with glucose~     intolerance who are overweight.~   "
123570|NCT01950026|"~     The aim of this study was to reheat the skin in different ethnic groups after application of~     cryotherapy.~   "
123571|NCT01950013|"~     The purpose of this study is to investigate the effectiveness of an auditory training program~     used at home with the subject's own hearing aids.~   "
123572|NCT01950000|"~     Background: Few studies have addressed the situation of procedural pain and the use of~     preemptive analgesia for turning in patients under mechanical ventilation.~      Aim: Evaluation effect of preemptive fentanyl on the incidence of pain during turning~     maneuvers in critically ill patients under mechanical ventilation.~      Design: Single-center clinical trial, national, randomized, double-blind, with a parallel~     group, and two arms of treatment: saline placebo and fentanyl.~      Primary Endpoint: Incidence of pain during the turning procedures that are carried out by~     nurses measured by means of the Behavioral Pain Scale (BPS).~      Study Population: Critically ill patients, age > 18 years, admitted to ICU and expected to~     require mechanical ventilation for at least 24 h.~      Sample Size: 80 patients divided into the two groups (40 patients each). Statistical~     Analysis: A preliminary descriptive analysis will be carried. Later, results of primary end~     point will be comparing after the eventual corrections of corresponding variables using a~     multivariable approach. The AUC variable will be analyzed by a t-test for unpaired data. A~     second analysis using a multivariate approach will be carried out for those factors~     considered as clinically relevant in relation to pain and therefore a logistic regression~     will be used.~      Ethical Considerations: The study will be strictly conducted following the Declaration of~     Helsinki and the protocol and Standard Operating Procedures (SOPs) to ensure compliance with~     the Good Clinical Practice (GCP) standards. It is the responsibility of the researcher to~     obtain the valid informed consent from the guardian / legal representative, as the patient's~     condition will not allow to consent. Before obtaining the consent the investigator will~     explain to each guardian / legal representative the nature of the study, its purpose, the~     procedures, the estimated duration, the potential risks and benefits associated with the~     participation, as well as any inconvenience that this may involve.~      Duration of Treatment: The treatment has a maximum duration of 60 min for each patient. The~     follow-up includes visits and has duration of 6 consecutive days.~      Safety Assessment: Potential side effects of treatments will be recorded. Frequent adverse~     effects of fentanyl administration include respiratory depression, apnea, muscle rigidity,~     bradycardia and transient hypotension.~   "
123573|NCT01949987|"~     Pain score after inguinal hernia repair surgery in children decreased as time passed in~     previous studies. Postoperative oral intake is usually resumed two hours after minor surgery~     in most of institutions, that may influence children's behavior and pain score.~      A recent study suggest that oral intake one hour after minor surgery does not increase the~     incidence of postoperative nausea and vomiting.~      The investigators primary endpoint is to clarify whether postoperative oral intake influences~     postoperative pain score in children.~   "
123574|NCT01949974|"~     The purpose of this clinical trial is to compare a non-pharmaceutical intervention (Integral~     Attention Program or PAI) versus standard palliative chemotherapy treatment plus PAI in~     patients with advanced cancer who have already received at least a first course of~     chemotherapy but had proven therapeutic failure.~      The study hypothesis is that palliative chemotherapy offers no clear benefits in relation to~     quality-of-life-adjusted survival compared to a comprehensive care program.~   "
123575|NCT01949961|"~     BACKGROUND: Thrombolytic drugs may dissolve blood vessel clots in acute ischemic stroke. The~     overall benefit of intravenous thrombolysis is substantial, but up to 2/3 of patients with~     large clots may not achieve re-opening of the vessel and up to 40% of the patients may remain~     severely disabled or die. Ultrasound accelerates clot break-up (lysis) when combined with~     thrombolysis (sonothrombolysis) and increases the likelihood of functional independence at 3~     months. Adding intravenous ultrasound contrast (gaseous microspheres) further enhances the~     thrombolytic effect (contrast enhanced sonothrombolysis = CEST). Contrast enhanced ultrasound~     may also accelerate clot break-up in the absence of thrombolytic drugs (contrast enhanced~     sonolysis = CES).~      HYPOTHESIS: Contrast enhanced ultrasound treatment administered within 4 1/2 hours after~     symptom onset may be given safely to patients with acute ischemic stroke, both to those~     receiving intravenous thrombolysis and those not receiving intravenous thrombolysis, and will~     improve clinical outcome.~      AIMS: To compare efficacy and safety of contrast enhanced ultrasound treatment vs. no~     ultrasound treatment in patients with acute ischemic stroke receiving or not receiving~     intravenous thrombolysis.~      STUDY ENDPOINTS: The primary endpoints are 1) neurological improvement at 24 hours (proof of~     concept) and 2) excellent clinical outcome at 3 months (effect). Secondary endpoints are~     bleeding complications (safety), brain damage (infarct size/location) and early clinical~     improvement (effect).~   "
123663|NCT01948817|"~     This is an open label, single arm, and multicenter study. The study will include the~     following phases. A screening phase which lasts for 4 weeks to determine patient eligibility.~     This phase will be followed by a 24 week Open label treatment phase. The study treatment is~     defined as deferasirox 20mg/kg BID 9Twice a day). Serum Ferritin Levels and MRI (Magmetic~     Resonance Imaging) LIC (Liver Iron Concentration) will be measured to evaluate the response~     to BID.~   "
123576|NCT01949948|"~     BACKGROUND: Alteplase dissolves blood vessel clots in acute ischemic stroke and is the only~     approved acute drug treatment <4½ hours of stroke onset. The overall benefit from alteplase~     is substantial, but up to 2/3 of patients with large artery clots may not achieve reopening~     of the vessel and up to 40% of the patients may remain severely disabled or die, leaving~     substantial room for improvement. Tenecteplase, widely used in coronary heart disease, may be~     more effective and may have less bleeding complications than alteplase, and may be the drug~     of choice also in stroke.~      HYPOTHESIS: Tenecteplase may be given safely to patients with acute ischemic stroke at a dose~     that is associated with improved clinical outcome compared with existing treatment options.~      AIMS: To compare efficacy and safety of tenecteplase vs. alteplase given <4½ hours after~     symptom onset.~      STUDY ENDPOINTS: The primary study endpoint is excellent clinical outcome at 3 months~     (effect). Secondary study endpoints are major early clinical improvement (effect) and~     bleeding complications (safety).~   "
123577|NCT01949935|"~     The hypothesis is that application of Mupirocin to the nose before and after coronary artery~     bypass grafting surgery will reduce the incidence of surgical site infections.~   "
123578|NCT01949922|"~     Aim:~      To investigate efficacy and safety in a new treatment with injection of autologous muscle~     fibers into the anal sphincter in patients with fecal incontinence.~      Method:~      Patients with fecal incontinence after obstetric anal sphincter rupture will be included.~     After inclusion, they will be offered 3 months of pelvic floor muscle training. If the~     patients after completion of pelvic floor muscle training still suffer from fecal~     incontinence, the patients will be offered treatment with autologous muscle fiber injection~     into the anal sphincter. The patients will be followed one year after the injection. The~     autologous muscle fibers are harvested at the patients leg muscle, cut into small pieces and~     injected into the anal sphincter. A small part of the fibers are used for analysing number of~     muscle stem cells and thereby the regenerative potential of the sample.~      The study is a pilot study.~   "
123579|NCT01949909|"~     P27A study is designed as a randomized phase Ia/Ib trial to evaluate the safety and~     immunogenicity of the blood stage candidate vaccine P27A against P. falciparum - P27A antigen~     and associated adjuvant (Alhydrogel or GLA-SE) - in malaria non exposed European~     volunteers(Switzerland; phase Ia) and malaria exposed African volunteers (Tanzania; phase~     Ib).~   "
123580|NCT01949896|"~     Prior to a non-urgent blood transfusion, subjects will be randomized to either stopping feeds~     or continuing feeds. The intervention group will be the placement of a subject in the NPO~     group. Subjects in the intervention group will have their feedings stopped for a total of 24~     hours around the time of the PRBC transfusion. These infants will be given intravenous~     nutrition during the period of time that they will not be fed. During the transfusion, both~     groups of subjects will have serum cytokine levels obtained at 3 time intervals- 1) 4 hours~     pre-transfusion, 2) 2-4 hours post-transfusion, and 3) 20-24 hours post-transfusion.~   "
123581|NCT01949883|"~     First in human, open-label, sequential dose escalation and expansion study of CPI-0610 in~     patients with progressive lymphoma. CPI-0610 is a small molecule inhibitor of bromodomain and~     extra-terminal (BET) proteins.~   "
123582|NCT01949870|"~     The objective of this study is to investigate the safety and tolerability of oral dose of~     selumetinib in combination with chemotherapies (cisplatin and gemcitabine) in Japanese~     patients with advanced biliary tract cancer (BTC). In addition, the pharmacokinetic (PK)~     profile of selumetinib and chemotherapies will be investigated. Also, the Maximum tolerated~     dose (MTD) of selumetinib in combination with chemotherapies for Japanese BTC patients will~     be identified, if possible.~   "
123583|NCT01949857|"~     The purpose of this Phase 4 trial is to assess the safety, immunogenicity, three-year immune~     persistence of inactivated hepatitis A vaccine (HAV) and live attenuated HAV vaccine.~   "
123584|NCT01949844|"~     This is a pilot study in a patient population with suspected Coronary Artery Disease CAD) as~     defined by the presence of an abnormal nuclear (PET/SPECT) perfusion scan. In this study~     design, PET/SPECT will serve as the comparative standard for presence of myocardial ischemia.~     We intend to determine the accuracy of a novel MR technique for localization of perfusion~     deficits in comparison to PET/SPECT.~      This is not a study to specifically evaluate the efficacy or safety of the drugs but rather~     the diagnostic accuracy of the cardiac MRI procedure as a whole~   "
123585|NCT01949831|"~     The aim of this study is to examine the effect of systematic assessment of functional~     ability, development of rehabilitation plan and follow-up at home for elderly medical~     patient's risk of readmission. The effect of the intervention is examined in a randomized~     controlled trial.~   "
123586|NCT01949818|"~     The purpose of this study is to evaluate the efficacy and safety of Yangzhengxiaoji Capsule~     Combination Chemotherapy for III/IV Diffuse Large B Cell Lymphoma.~   "
123587|NCT01949805|"~     Phase III study to compare the efficacy and safety of the novel monopegylated interferon~     alpha 2b AOP2014 versus Hydroxyurea (the current licensed therapy for this disease). One year~     treatment of patients with polycythemia vera. Objective is to demonstrate non-inferiority of~     AOP2014 vs. HU in terms of disease response rate in both HU naïve and currently treated~     patients, diagnosed with Polycythemia Vera. Response is measured as normalisation of key lab~     parameters as well as normalized spleen size.~   "
123588|NCT01949792|"~     This trial is conducted in Europe. The aim of the trial is to investigate the~     pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the~     effect of the investigated drug on the body) of rFVIIa (activated coagulation factor VII)~     following one single injection of 270 microg/kg compared to three injections of 90 microg/kg~     rFVIIa in patients with haemophilia.~   "
123589|NCT01949779|"~     The primary objective of this registry is to collect real world data on the safety and~     performance of the TransForm™ Occlusion Balloon Catheter when used in current~     neurointerventional procedures~   "
123590|NCT01949766|"~     This is a single patient compassionate use protocol to determine whether RAVICTI will improve~     bile flow in a subject who previously tolerated therapy with Buphenyl.~   "
123591|NCT01949753|"~     Characterization of the influence of pregnenolone vs. placebo on subjective distress and~     autonomic functioning during cognitive-behavioral exposure therapy in patients with~     obsessive-compulsive disorder.~   "
123593|NCT01949727|"~     Chronic obstructive pulmonary disease (COPD) is a chronic lung disease primarily caused by~     smoking. COPD creates a tremendous burden to the healthcare system, as disease exacerbations~     result in frequent, prolonged hospitalizations. While originally considered a disease~     specific to the lung, data have shown that COPD is associated with substantial cardiovascular~     (CV) morbidity and mortality. Exacerbations of COPD requiring hospitalization result in~     marked patient deterioration, and heightened CV risk. The cause of the increased CV risk with~     stable COPD, and the exaggerated CV risk during exacerbations of the disease are unknown;~     however, it may be due to chronic inflammation which is exacerbated with a flare-up of the~     disease, and/or chronic inactivity which is similarly worsened with bed-rest during a~     hospitalization. Despite the impact of COPD on healthcare, there are relatively few studies~     examining how COPD inpatient care impacts on patient outcomes, inflammation and CV risk.~     Disease management programs, such as pulmonary rehabilitation and patient self-management~     education, are part of guideline therapy for COPD; however, these are not regularly~     implemented following a hospitalization, and how these interventions affect patient outcomes,~     behavior, physical activity, inflammation and CV risk have not been well studied. The~     proposed long-term project will examine how typical inpatient COPD care, and how early~     referral to chronic disease management programs after hospital discharge, affect patient~     outcomes. This grant brings together an outstanding group of researchers who have the~     necessary clinical, content and methodological expertise to successfully complete this work.~     These studies will provide invaluable information about inpatient and outpatient management~     for a disease which has a tremendous impact on healthcare.~   "
123594|NCT01949714|"~     -  To investigate the effect of catecholamine excess on brown fat.~        -  To evaluate the effect of brown fat on energy expenditure and lipid and glucose~          metabolism~   "
123595|NCT01949701|"~     The investigators previously identified a novel HLA-A*0201-restricted epitope peptide, which~     was derived from a cancer-testis antigen, URLC10 as a target for vaccination against lung~     cancer. In this clinical study, the investigators examine using the peptides the safety,~     immunogenicity, and antitumor effect of vaccine treatment to prevent relapse of the disease~     for HLA-A*0201-positive advanced non-small cell lung cancer patients whose disease are~     controlled after any standard therapies.~   "
123596|NCT01949688|"~     In this study, the investigators examine using a combination of two types of HLA-A*2402 (or~     HLA-A*0201)-restricted epitope peptides, which were derived from VEGF-R1 and VEGF-R2 the~     safety, immunogenicity, and antitumor effect of vaccine treatment for advanced solid tumor~     patients who are refractory to standard therapy.~   "
123597|NCT01949675|"~     The aim of the study is to generate safety and immunogenicity data with Oral Cholera Vaccine~     (Shanchol™) in The Philippines~      Objectives:~        -  To describe the safety after each dose of Shanchol vaccine.~        -  To describe the immunogenicity after each dose of Shanchol vaccine.~   "
123598|NCT01949662|"~     The goal of this clinical research study is to learn if giving lorazepam in combination with~     haloperidol can help to control the symptoms of delirium in patients with advanced cancer.~     The safety of this drug combination will also be studied.~      In this study, lorazepam is being compared to a placebo. A placebo is not a drug. It looks~     like the study drug but is not designed to treat any disease or illness. It is designed to be~     compared with a study drug to learn if the study drug has any real effect.~   "
123599|NCT01949649|"~     Five percent of young women meet criteria for anorexia nervosa, bulimia nervosa, or binge~     eating disorder, with another 5% meeting criteria for Eating Disorder Not Otherwise Specified~     (ED-NOS), which includes subthreshold variants of these disorders. Over half of those~     presenting for eating disorder treatment meet criteria for ED-NOS and both threshold cases~     and ED-NOS are marked by chronicity, relapse, distress, functional impairment, and increased~     risk for future obesity, depression, suicide attempts, anxiety disorders, substance abuse,~     morbidity, and mortality. Anorexia and bulimia nervosa show stronger relations to suicide~     attempts, outpatient/inpatient treatment, and functional impairment than most other~     psychiatric disorders. Treatment of eating disorders is very expensive, similar to the cost~     for schizophrenia treatment, and is effective for only 40-60% of patients. Thus, a public~     health priority is to develop and disseminate effective eating disorder prevention programs.~   "
123600|NCT01949636|"~     The purpose of this study is to test the dynamic vulnerability model of obesity using brain~     imaging.~   "
123601|NCT01949623|"~     In this study, markers of oxidative stress will be measured in the aqueous humour and plasma~     of RP patients compared to controls.~   "
123602|NCT01949610|"~     The purpose of this study is to evaluate the absorption, the metabolic pathways (a series of~     metabolic reactions) and the excretion of JNJ26489112 in healthy male adult participants~     after administration of a single oral dose of 1000 mg of 14C-JNJ26489112.~   "
123603|NCT01949597|"~     The recurrence of endometriosis after surgery a formidable challenge for the gynecologist.~     Recurrence rates reported in the literature are very high, being 21.5% at 2 years and 40-50%~     at 5 years. Several theories attempt to explain these high figures. The three most widely~     accepted are:~        -  The presence of residual endometriotic tissue or residual endometriotic cells not~          completely eradicated during surgery~        -  The growth of undetected microscopic endometriosis during surgery~        -  The development of endometriotic lesions de novo Patients with symptomatic endometriosis~          diagnosed by ultrasound or MRI and suitable for surgery will participate in the study.~          The surgical specimens sent for pathology from bladder, vagina, uterosacral, sigma or~          rectum will be properly marked for studying the presence of endometriosis.~   "
123604|NCT01949584|"~     This is a prospective, interventional, study in which patients with a history of habitual~     snoring to determine whether low pressure nasal continuous airway pressure can reduce the~     frequency, duration or intensity of snoring in subjects with mild to moderate snoring who do~     not have Obstructive Sleep Apnea (OSA).~   "
123664|NCT01948804|"~     The comparison of effect of four different treatment protocols: Antagonist/letrozole~     protocol, microdose flare-up protocol, Antagonist/clomiphene protocol, Antagonist on IVF~     outcomes in poor responders undergoing in vitro fertilization; a prospective~     randomized-controlled study.~   "
123665|NCT01948791|"~     To investigate the efficacy of Exelon capsule at maximal tolerated dose in mild to moderate~     Chinese AD patients via dosage titration from 3mg/d to 12mg/d in a 16 weeks duration~   "
123605|NCT01949571|"~     INTRODUCTION. One of the main problems of the treatment of cocaine-dependent patients is the~     high rate of relapses occurs within the first months after detoxification. In the early~     withdrawal phase, patients suffer severe anxious depressive symptoms, known in the argot as~     crash, which occurs in parallel with an appetite overflowed by re-experiencing the effects of~     the substance, known as craving. Most of the times, these clinical symptoms act as negative~     reinforcement, which can be severe enough to induce a drug-relapse that greatly hampers the~     treatment.~      TYPE OF STUDY randomized, double-blind, placebo-experimental. GENERAL PURPOSE To determine~     the efficacy of mirtazapine for the treatment of cocaine dependence. SPECIFIC OBJECTIVES 1)~     To evaluate the efficacy in the treatment of craving in individuals with cocaine dependence~     disorder treated with mirtazapine during acute withdrawal phase. 2) Determine the efficacy of~     reducing anxious depressive symptomatology (Crash) associated with acute withdrawal in~     subjects with cocaine dependence disorder treated with mirtazapine. 3) Evaluate the~     maintenance of abstinence in patients with cocaine dependence disorder treated with~     mirtazapine. 4) Determine the efficacy of mirtazapine in the treatment of subjects dependent~     on cocaine comorbid with major depressive disorder.~      HYPOTHESIS For pharmacokinetics and pharmacodynamics mirtazapine contribute to the reduction~     in the intensity of withdrawal symptoms in cocaine dependent subjects by acting on the~     neurochemical circuitry involved in the reward-seeking behavior and has a prolonged effect~     anticraving. METHOD The attending physician outpatient identifies the Addiction Clinic of the~     National Institute of Psychiatry who meet the inclusion criteria and invite them to~     participate voluntarily. If patients accept, send them to the principal investigator for the~     start of the ratings. Demographics INSTRUMENTS, MINI structured interview, Anxiety and~     Depression Scale Beck Scale.~   "
123606|NCT01949558|"~     Chronic diseases such as overweight and cardiovascular diseases represent important threats~     to women's health. Pregnancy and lactation are associated with changes in weight, body~     composition and lipid metabolism and affect the risk of developing these chronic illnesses.~     Our group has conducted a randomized clinical trial (LEVA) to evaluate overweight/obese~     women's ability to make longterm lifestyle changes during the postpartum (pp) period, under~     ideal study conditions. Physiological mechanisms for weight reduction were investigated with~     precise methodology. However, effectiveness studies under different conditions are crucial~     for the development of effective programs for the Primary Health Care sector. Hence, the~     interest for translational research that brings results from clinical trials to the Primary~     Health Care sector has increased. The aim of this effectiveness-study is to investigate if~     dietary restrictions pp lead to significantly greater weight reduction among overweight/obese~     women, compared to no intervention, in a longterm perspective. In total 106 women will be~     recruited 10 wk pp and randomized into 1) control group; 2) dietary restrictions in~     individualized intervention during 12 wks. One and two years pp long term effects are~     evaluated. Positive results may be integrated into usual practice after the study ends.~   "
123607|NCT01949545|"~     The purpose of this study is to compare the safety and efficacy of carfilzomib, including~     measuring the amount of the study drug in the blood at certain times following dosing. This~     study is being done in people with varying degrees of liver function to see if they respond~     differently to the study drug.~   "
123608|NCT01949532|"~     The purpose of this study is to see how the body and the cancer react to carfilzomib,~     including measuring the amount of the study drug in the blood at certain times following~     dosing. This study is being done in people with normal kidney function and those with~     end-stage renal disease to see if they respond differently to the study drug.~   "
123609|NCT01949519|"~     Docetaxel is the standard, first-line chemotherapeutic agent for castrate resistant prostate~     cancer. While it has clinically useful activity, there is a strong need for substantial~     improvement in its efficacy. Possible ways for improving docetaxel monotherapy would be to~     combine it with an agent that either minimized toxicity (thus allowing higher doses) or~     improves efficacy (by targeting synergistic pathways). Lycopene is an attractive agent for~     combination with docetaxel because of its known accumulation in prostate tissue, its low~     toxicity, and its ability to inhibit signaling through the IGF-1 axis, and to reduce IL6~     levels. Lycopene is highly synergistic with docetaxel at inhibiting the growth of prostate~     cancer in mice. The purpose of this study is to determine the maximum tolerated dose (MTD) of~     lycopene given in combination with docetaxel. This dose can then be used for subsequent phase~     II or phase III studies.~      New findings from the ECOG E3805 study presented at ASCO 2014, showed that concurrent~     chemotherapy with first-line ADT for newly diagnosed metastatic prostate cancer markedly~     improved overall survival compared with delayed or no chemotherapy. These subjects could also~     benefit from intervention to increase docetaxel effectiveness.~   "
123610|NCT01949506|"~     This is a prospective study to document the local control rates with SBRT specifically for~     pulmonary metastases from soft tissue sarcoma. This study will prospectively document acute~     and late toxicity, quality of life (QoL), tumor control, and survival.~   "
123611|NCT01949493|"~     The objective of this study is to evaluate the effectiveness of mechanical traction in~     patients with Carpal Tunnel Syndrome compared to care as usual.~   "
123612|NCT01949480|"~     The overall purpose of this research study is to compare the effectiveness of ultrasound~     assisted paravertebral block placement versus traditional blind technique for postoperative~     analgesia following thoracotomy or visually assisted thoracoscopic surgery.~   "
123613|NCT01949467|"~     The diagnosis of iron overload is a common problem. It is important to optimize the diagnosis~     to ensure support for patients and their relatives especially regarding genetic disease.~      Iron overload revealed by a high level of serum ferritin and confirmed by the presence of an~     excessive amount of iron in the liver is a frequent situation. In a lot of case there is no~     increase in serum iron and transferrin saturation. This situation may arise in particular in~     patients with:~        -  a genetic iron overload related to mutation in the ferroportine gene, leading to a~          ferroportin disease. The diagnosis is based on the sequencing of the gene,~        -  a dysmetabolic hepatosiderosis, the most frequent situation , where iron overload is~          associated with abnormalities in the metabolism of carbohydrates and fats, whereas no~          genetic cause is identified.~      However, patients often have similar biological signs and despite the implementation of~     strict algorithm regarding the diagnostic procedure, it appears that a large number of~     patients are tested for the mutation in the ferroportin gene, and that mutation is not found~     in most cases. It is therefore essential to optimize the diagnosis process by introducing~     additional criteria.~      The investigators' hypothesis, based on the known elements, is that the response to a single~     dose of iron will modulate differently the iron parameters measured in serum, including~     hepcidin level which controls iron metabolism and metals associated with iron. This could be~     helpful for diagnosis procedure in patients with ferroportin disease or dysmetabolic~     hepatosiderosis.~   "
127446|NCT01899235|"~     A randomised open-label pilot study to assess the safety and efficacy of treatment with a~     drug eluting balloon alone in coronary de novo lesions). Elective patients requiring PCI to~     coronary de novo lesions in vessels 2.5 mm - 4.0 mm.~   "
123614|NCT01949454|"~     The investigators aim to evaluate a new potentially cost-effective approach to improving~     trichiasis surgery outcomes, perioperative topical anti-inflammatory therapy. The~     investigators hypothesize that adjunctive topical fluorometholone therapy following~     trichiasis surgery will reduce the risk of recurrent trichiasis. The rationale for this~     hypothesis is that interruption of inflammation postoperatively would reduce postoperative~     scarring, leading to better outcomes. As an initial step toward evaluating this modality, the~     investigators believe it to be necessary to evaluate topical corticosteroid therapy in a~     safety-oriented study, for which the investigators also hypothesize that fluorometholone will~     have a perioperative safety profile acceptable for large-scale programmatic use. Topical~     corticosteroid therapy is associated with potential risks of cataract induction and~     intraocular pressure (IOP) elevation in susceptible individuals. Fluorometholone has lower~     intraocular penetration than alternative corticosteroids, with correspondingly less~     IOP-raising effect while still having favorable effects on conjunctival inflammation, and is~     a low-cost generic drug. Its poor delivery of corticosteroid into the eye itself provides an~     advantage in this setting, as the major side effects of therapy are the result of intraocular~     effects, and therapy only is needed to the conjunctiva. However, prior to use in a~     large-scale trial it is sensible to make sure adverse outcomes are not observed in a~     substantial number of TT patients in a smaller scale trial. Secondary goals of such a trial~     are to evaluate alternative topical corticosteroid dosing schedules to identify an optimal~     dosing schedule and to identify any preliminary signals of potential efficacy.~   "
123615|NCT01949441|"~     House Dust Mites (HDMs) are arachnids that infest bedding, carpet, upholstered furniture and~     fabric. Like many other allergens, exposure to HDMA in sensitised patients is associated with~     poorer lung function, greater medication requirements and more asthma symptoms as well as~     chronic rhinosinusitis symptoms. In contrast to other allergens, there is evidence that HDMA~     leads to the development of asthma, in addition to exacerbating pre-existing asthma in~     HDM-sensitised patients.~      ToleroMune House Dust Mite (TM-HDM), a combination of seven Synthetic Peptide~     Immuno-Regulatory Epitopes, is being developed for the treatment of HDM allergy.~      This study to assess the tolerability of ToleroMune House Dust Mite in subjects with~     controlled asthma and house dust mite-induced rhinoconjunctivitis.~   "
123616|NCT01949428|"~     A Field Study to Observe Symptom Scores and Allergy Medication Usage in Subjects with a~     History of House Dust Mite-Induced Rhinoconjunctivitis~   "
123617|NCT01949415|"~     House Dust Mites (HDM) are arachnids that infest bedding, carpet, upholstered furniture and~     fabric. Like many other allergens, exposure to HDMA in sensitised patients is associated with~     poorer lung function, greater medication requirements and more asthma symptoms as well as~     chronic rhinosinusitis symptoms. In contrast to other allergens, there is evidence that HDMA~     leads to the development of asthma, in addition to exacerbating pre-existing asthma in~     HDM-sensitised patients.~      ToleroMune House Dust Mite (TM-HDM) is being developed for the treatment of HDM allergy.~      Study TH002 evaluated the efficacy, safety and tolerability of TM-HDM. This study will~     identify cellular, proteomic or genetic biomarkers of efficacy to TM-HDM treatment in TH002~     study participants~   "
123618|NCT01949402|"~     There is increasing interest in how thoracic (chest) ultrasound might enhance the management~     of patients with respiratory failure and breathlessness, particularly in the emergency~     admissions or intensive care setting. Thoracic ultrasound is already used in a number of~     clinical settings. It is recognised that a number of lung abnormalities can be identified~     using thoracic ultrasound, such as consolidation (in pneumonia) or peripheral soft tissue~     lesions (in lung cancer). Furthermore, thoracic ultrasound offers clinicians a non-invasive~     diagnostic tool that provides immediate feedback and results.~      Patients with breathlessness and respiratory failure represent a significant proportion of~     emergency admissions to hospital and commonly require urgent treatment with limited~     information available to guide the clinician. The range of diseases that present with~     breathing difficulties is broad (e.g. pneumonia, heart failure, pulmonary embolus) and~     difficult to differentiate in patients who often have multiple medical problems. This leads~     to non-specific treatment in the face of diagnostic uncertainty with the associated risks of~     treatment complications, increased morbidity and mortality, and distress for patients and~     relatives. It is in the assessment of these patients with acute respiratory failure where~     thoracic ultrasound might be of greatest benefit and which this research is designed to~     address.~      This is a single centre study (Churchill Hospital, Oxford) recruiting 125 participants over~     an eight month period. The study will test the reliability of a thoracic ultrasound protocol~     at identifying lung abnormalities in a stable outpatient population with respiratory disease~     (chronic obstructive pulmonary disease; interstitial lung disease; patients on haemodialysis~     to replicate acute pulmonary oedema / heart failure). It is hoped the results of this study~     will inform further research in acutely unwell patients with respiratory failure and~     breathlessness to see whether thoracic ultrasound can improve diagnostic and therapeutic~     decisions.~   "
123619|NCT01949389|"~     The purposes of this study is to examine the feasibility of implementing an internet-based~     treatment for insomnia among veterans with substance use disorders, some with co-morbid~     serious mental illness, and to develop potential methods to support and encourage veterans~     while they self-administer this treatment. Our hypotheses are that the implementation of an~     internet-based therapy will be feasible and that a method of support can be devised, and~     tested in the future.~   "
123620|NCT01949376|"~     The purpose of this study is to improve our understanding of potential changes in size, shape~     and activity in some brain areas that can occur in women receiving different types of Breast~     Cancer therapy, and how these changes are related to the development of mild cognitive~     impairment as the result of these treatments.~   "
123621|NCT01949363|"~     This study is a Phase I, open label, non-randomized, dose-frequency escalation~     pharmacokinetics study among 24 healthy male and female subjects, aged 18 to 45 years to~     determine the pharmacokinetics and safety of high-, multi-dose cefixime for the treatment of~     reduced susceptibility gonorrhea. Stage 1(Cohorts A and B) will examine the pharmacokinetics~     of single 400mg and 800mg dose of cefixime. Stage 2(Cohorts C and D) subjects will take 800mg~     of cefixime every 12 hours for 2 doses. If that dosing regimen is well tolerated, the~     dose-frequency will escalate to 800mg every 8 hours for 3 doses, and serum levels of cefixime~     will be measured. Study duration is approximately 47 weeks.~   "
123697|NCT01948375|"~     Placebo needle is a useful tool to assess the efficacy of acupuncture. Investigators have~     applied a new kind of placebo needle in large scale acupuncture clinical trials, which named~     as pragmatic placebo needle. Compared with other placebo needles used in acupuncture trials,~     this pragmatic placebo needle shows several advantages: the outlook closer to traditional~     acupuncture needles, no restriction to needle depth of true needle, simple to manipulate and~     more economical. However, its blinding effect is not yet validated. The primary objective of~     this trial is to validate the blinding effect of the new pragmatic placebo needle; the~     secondary objective is to explore factors influencing the blinding effect of the placebo~     needles.~   "
123622|NCT01949350|"~     Major non-cardiac surgery has a high degree of morbidity and mortality. Recently, measurement~     of a patient's preoperative cardiorespiratory reserve, performed non-invasively by~     cardiopulmonary exercise testing, has been shown to be predictive of outcome following~     non-cardiac surgery. All patients prior to major surgery are starved for a minimum of 6 hours~     and often longer prior to major elective surgery. It has been shown that elite athletes who~     are hypohydrated have reduced exercise capacity and lower cardiorespiratory function. These~     results are further exaggerated in non-trained individuals. Therefore, the starvation~     policy prior to surgery may have a deleterious effect on outcome after surgery.~      4.2 AIMS This is a pilot study of health volunteers to assess the role of carbohydrate (CHO)~     (preload) and carbohydrate-protein (CHO-P) (Highfive energy source 1 in 4) in improving~     aerobic capacity after a period of fasting mimicking the current starvation policy prior to~     surgery. Both of these have similar calorific value and only differ in the amount of~     carbohydrate and protein supplementation.~   "
123623|NCT01949337|"~     This randomized phase III trial studies enzalutamide to see how well it works compared to~     enzalutamide, abiraterone, and prednisone in treating patients with castration-resistant~     metastatic prostate cancer. Androgens can cause the growth of prostate cancer cells. Drugs,~     such as enzalutamide, abiraterone acetate, and prednisone, may lessen the amount of androgens~     made by the body.~   "
123624|NCT01949324|"~     This study is a phase 2, randomized, multi-center, single-masked study to evaluate the~     efficacy and safety of the NT-501 implants in participants with Mactel.~   "
123625|NCT01949311|"~     This is an open label extension study for patients who participated in placebo-controlled~     dupilumab atopic dermatitis (AD) trials. The study primarily evaluates long term safety~     (adverse events) and immunogenicity. Efficacy parameters are based on Investigator Global~     Assessment (IGA), Eczema Area and Severity Index (EASI) and the Pruritus Numerical Rating~     Scale (NRS).~   "
123626|NCT01949298|"~     Edentulous patients have to wait after extractions and again after surgical implant placement~     for healing to occur before the implants can be restored and patients can go back to normal~     function. This delay in loading of implants can be handicapping for the patient, esthetically~     and functionally. Hence this project was undertaken with the purpose of reducing this wait~     period and achieving early rehabilitation in these patients. The aim of the project is to~     compare immediate loading versus delayed loading of implant supported mandibular dentures.~   "
123627|NCT01949285|"~     This study is to determine if non-invasive electrical stimulation of the spinal cord can be~     used to: 1) assess spared function following a spinal cord injury; and 2) be use for~     rehabilitation.~   "
123628|NCT01949272|"~     Actual setting of PEEP in ARDS is based on tables linked to FiO2, or respiratory system~     plateau pressure (e.g EXPRESS Study) or set regarding esophageal pressure mesurement and~     transpulmonary pressure calculation. Opera study should confirm if a setting approach based~     on esophageal pressure is helpfull for any ARDS patient in ICU without deleterious~     side-effect.~   "
123629|NCT01949259|"~     A retrospective, data mining project that re-uses routine patient care data for decision~     support systems.~   "
123630|NCT01949246|"~     The prospective study aims:~        1. To determine the role and mechanism of biomarkers for prediction of response to CRT~        2. To determine the role of biomarkers and their effect on left ventricular remodeling in~          patients undergoing CRT.~   "
123631|NCT01949233|"~     The primary objective of the trial is to estimate the effects of allocation to irbesartan, or~     doxycycline, or a combination of both irbesartan and doxycycline, compared with placebo, on~     measures of elastic function of the aorta in people with the Marfan syndrome and enlargement~     of the aorta.~   "
123632|NCT01949220|"~     Collect information about WILLFACT or WILFACTIN in their real life clinical use and identify~     the therapeutic practices in an international environment.~   "
123633|NCT01949207|"~     The aim of this randomised case-controlled trial is to investigate whether ablation of~     incompetent perforating vein in addition to ablation of truncal vein reduces the rate of~     recurrent varicose veins post-treatment compared with patients who only have ablation of the~     truncal vein, who are left with untreated incompetent perforating veins.~   "
123634|NCT01949194|"~     In recent years, anti-angiogenic agents have been incorporated into clinical practice for the~     treatment of metastatic CRC, leading to improvements in progression-free survival and overall~     survival. Regorafenib is an oral multi-kinase inhibitor that targets angiogenic and oncogenic~     kinases. Although structurally similar to another multi-kinase inhibitor, sorafenib, it~     appears to be pharmacologically more potent and possesses broader antiangiogenic properties.~      Both sorafenib and regorafenib target BRAF wild-type and BRAF V600E mutant but the inhibition~     of p38 MAP kinase is a peculiar characteristic of regorafenib. A Phase I study of regorafenib~     as a single agent in patients with heavily pretreated CRC showed promising clinical activity~     with a disease control rate (PR + SD) of 59% in evaluable patients. In the Phase III trial~     (CORRECT), which was a randomized double-blind, placebo-controlled study comparing either~     regorafenib plus best supportive care (BSC) or placebo plus BSC, it was shown that~     regorafenib significantly increased overall survival (OS), progression-free survival (PFS)~     and disease control rate (DCR), independently of KRAS status. A major interest, given the~     data presented in the CORRECT trial, is to determine predictive biomarkers to indicate~     patients likely to benefit, or to be resistant to this anti-angiogenic compound.~      This study aims to determine the efficacy of regorafenib as single-agent treatment for the~     treatment of second-line metastatic colorectal cancer and to identify predictive biomarkers~     in the actual metastatic tumors to be treated. In the case of metastatic CRC patients, liver~     lesions are frequently the most common site of metastatic deposit and these lesions can be~     biopsied to assess putative biomarkers. Patients will be asked to undergo a biopsy of a~     metastatic lesion prior to treatment, and an optional liver biopsy at the time of relapse.~     Using several high-throughput discovery platforms, biomarkers will be identified in the~     metastatic tumor specimens and in blood samples collected throughout the treatment. This will~     allow us to evaluate putative biomarkers and monitor tumor biomarker dynamics using serial~     blood collection.~      The objectives of this trial are to help identify the patient subgroup most likely to be~     responsive or resistant to regorafenib, so that future treatment with regorafenib can be~     directed to the more responsive but as yet identified patient population.~   "
123635|NCT01949181|"~     Prospective research to study the relationship between concentrations of metals/metalloids in~     blood, hair and lung tissue with the occurence of lung cancer or chronic obstructive~     pulmonary disease.~   "
123636|NCT01949168|"~     The purpose of this study is to evaluate the antiviral efficacy of Boceprevir-based therapy~     for the treatment of genotype 6 chronic hepatitis C infection.~      Boceprevir has recently been approved for the treatment of genotype 1 chronic hepatitis C~     infection. Recent in vitro studies suggest similar efficacy against genotype 6 chronic~     hepatitis C infection.~      The investigators therefore hypothesise that:~      i) Boceprevir is a potent inhibitor of genotype 6 hepatitis C replication in vivo.~      ii) Boceprevir in combination with pegylated interferon-alpha and ribavirin for 24 weeks will~     cure a high proportion of patients chronically infected with genotype 6 chronic hepatitis C~     infection.~   "
123639|NCT01949129|"~     The ALL SCTped 2012 FORUM is a multinational, multi-centre, randomized, controlled,~     prospective seamless phase II/III study for the therapy and therapy optimisation for children~     and adolescents with ALL in CR, who have an indication for HSCT (hematopoetic stem cell~     transplantation) with a myeloablative conditioning regimen.~      The stratification and randomisation of patients in first and following remission according~     to the individual transplantation modalities rests upon an indication for allogeneic HSCT AND~     on the availability of a suitable donor within the individual transplantation groups.~      Main objectives - Objective 1: Randomisation of TBI vs non-TBI conditioning regimen for~     patients with a HLA matched-sibling donor or unrelated HLA matched donor.~      We aim at showing that a non-total body irradiation (TBI) containing conditioning~     (Flu/Thio/ivBu or Flu/Thio/Treo) results in a non-inferior survival as compared to~     conditioning with TBI/Etoposide in children older than 4 years after HSCT from a Human~     leucocyte antigen (HLA) identical sibling donor (MSD) or a HLA matched donor (MD).~      - Objective 2: Stratification of patients with a HLA mismatched donor according to stem cell~     source.~      We aim at exploring event free survival (EFS) after HSCT from HLA mismatched donors using~     mismatched unrelated donors (MMD), mismatched cord blood or HLA haplo-identical family~     members with non TBI-conditioning regimen.~   "
123640|NCT01949116|"~     People with HIV infection who are taking antiretroviral therapy (ART) could be at risk for~     cardiovascular disease (CVD), which can be caused by inflammation. Methotrexate (MTX) is a~     medication used to treat inflammation in people with rheumatoid arthritis. This study~     evaluated the safety and effectiveness of low-dose methotrexate (LDMTX) at reducing~     inflammation in HIV-infected adults.~   "
123641|NCT01949103|"~     TD-1607, administered intravenously as multiple ascending doses, will be investigated in~     healthy subjects to assess its tolerability, safety, and pharmacokinetics.~   "
123642|NCT01949090|"~     The purpose of this placebo controlled study is to evaluate the safety and immunogenicity of~     different formulations of GSK Biologicals H7N1 influenza vaccine in subjects 65 years of age~     and older. The study will evaluate safety related events and antibody immune responses to~     different formulations of study vaccine.~   "
123643|NCT01949077|"~     The purpose of the study is to determine differences in levels of serum chemokines from~     patients undergoing treatment with Boceprevir. The aim is to determine if non-responders have~     significantly different levels of chemokines than responders.~   "
123644|NCT01949064|"~     The treatment of craniomandibular disorders is a challenging task. Many different treatments~     are yet available with occlusal splints being one of the most commonly used. A relative new~     diagnostic and treatment alternative is the Grindcare device. This enables the~     electromyographic (EMG) assessment of the activity of the temporal muscle and the contigent~     electrical stimulation of this muscle as bio-feedback whenever the EMG activity exceeds a~     certain limit. This stimulation results to a sudden break of the muscle activity.~      Aim of this study is to compare the therapeutic efficacy of the Grindcare device in pain~     reduction at female non-chronic CMD patients to that of a Michigan-type splint. Our~     null-hypothesis was that there is no difference between the device and the splint in the~     reduction of pain intensity.~   "
123645|NCT01949051|"~     This study will be a randomized, double blind, placebo controlled, 3-way cross over design in~     allergic rhinitis subjects. Subjects will receive repeat doses of intra-nasal levocabastine~     for 7 days in each period and the duration of the study will be about 13 weeks. An~     Environmental Exposure Chamber (EEC) will be used in this study. The primary objective of the~     study is to investigate the non-inferiority effect of 7 days treatment with levocabastine on~     nasal symptoms elicited by an EEC when administered once daily (QD) compared with twice daily~     (BID). Also study will be conducted to investigate the superiority of effect of 7 days~     treatment with levocabastine (QD and BID) on nasal symptoms elicited by an EEC in subjects~     compared to placebo.~   "
123646|NCT01949038|"~     Diagnostic esophagogastroduodenoscopy is an uncomfortable and stressful procedure for most of~     the patients. Various methods are available for sedation during this procedure. Because of~     some side effects related to intravenous administration of sedatives, oral administration of~     these drugs is under attention. Alprazolam is a benzodiazepine which is used mainly in~     treatment of anxiety. Hence, we determine the efficacy of oral and sublingual alprazolam as~     for sedation during this procedure. We hypothesize that sublingual alprazolam is more~     effective than that oral form and both forms more effective than placebo in reducing anxiety~     and pain/discomfort related to the procedure.~   "
123647|NCT01949025|"~     1. Summary~           Growing evidence suggests that a significant proportion of in-hospital patient deaths~          occur after serious adverse events (SAE's). Concerns have been raised that too often~          patients' acute deteriorations, particularly on surgical and medical wards outside~          critical care settings, are identified too late and corrective actions taken too slowly.~          Many initiatives have been taken to prevent unexpected death by timely recognition,~          intervention and resuscitation efforts such as Rapid Response Systems (RRS's). RRS's~          have been introduced with the intention to prevent SAE's and to improve patient outcome~          by facilitating early detection of warning signs for clinical deterioration. These~          systems have four components (1) an afferent limb for detection and response triggering,~          (2) an efferent limb with medical or nursing response to prevent deterioration (3) a~          process improvement limb and (4) a governance and administrative structure. It remains~          uncertain which elements of RRS's contribute most to patient outcomes such as unplanned~          (re-) admission to the intensive care unit, shock, cardiac arrest and unexpected death.~          In addition, previous studies found that nurse observation, assessment and communication~          (afferent limb) are crucial to achieve better patient outcomes, but how to achieve~          afferent limb sustainability in hospitals is not clear.~           A previous study investigated 23 hospitals in Flanders (Belgium) about how nurses~          observe, assess, detect and communicate deteriorating and critical patients in surgical,~          medical and geriatric wards. Wide variation between hospitals was identified about~          critical patient intervention procedures, strategies and Do Not Attempt Resuscitation~          (DNAR) orders as well as between nurses about the use and knowledge of critical vital~          signs and call criteria for physician clinical advice and support. Nurses of hospitals~          with structured observation and communication protocols were better informed and~          perceived their communication and collaboration with physicians more favorable in~          compared to other hospitals. Based on these results conclusions and recommendations for~          further initiatives were formulated. The proposed Afferent Limb and Response Method~          intervention study will implement these recommendations guided by a robust scientific~          research approach to offer evidence to the nursing and medical practice community.~           The aim of this study is to evaluate the effect of the Afferent Limb Ascertainment and~          Response Method intervention or ALARM intervention in medical and surgical nursing wards~          of acute care hospitals on the prevention of SAE's such as in-hospital unexpected death,~          unplanned ICU-admission and cardiac arrest.~        2. Study hypothesis~      Optimizing and supporting the process of observation, use and interpretation of vital signs,~     detection, assessment, escalation and communication with a higher level of care in~     deteriorating patients can prevent serious adverse events (in-hospital unexpected death,~     unplanned ICU admission and cardiac arrest) in acute care hospitals.~   "
123698|NCT01948362|"~     To determine the safety and tolerability of single escalating doses of Sulforadex® in healthy~     male volunteers.~   "
123800|NCT01947023|"~     This phase I trial studies the side effects and best dose of lapatinib ditosylate when given~     together with dabrafenib in treating patients with thyroid cancer that cannot be removed by~     surgery and has not responded to previous treatment. Dabrafenib and lapatinib ditosylate may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
123648|NCT01949012|"~     Dentists use sedation to help patients accept difficult procedures and to relieve anxiety.~     During sedation, the well-being of the patient is monitored by the dental team. When carried~     out according to recognised guidelines,intravenous dental sedation is considered to be very~     safe. For some patients, dental sedation is a useful alternative to general anaesthetic. It~     is cheaper and has the potential to be more accessible. Oximetry(measurement of oxygen~     status) is the current gold standard in dental sedation. The main risk to the patient during~     sedation is a slowing of breathing due to the effects of the sedative drug. Studies from~     other settings where sedation is practiced suggest that an additional monitor with~     capnography facilitates early detection of depressed breathing. However, the results of~     studies from other medical settings cannot be generalised to dental sedation, because of~     different techniques used and the types of patients. The depth of sedation may also be vary.~     For dental sedation, patients remain responsive at all times and breathe for themselves.~     Capnography gives breath by breath information using a simple device placed close to the nose~     and mouth. It has been recommended by several governing medical bodies that each area of~     medicine, should develop its own guidelines for sedation. Therefore, there is a need to~     research the application of capnography for dental sedation. The proposed study will take~     place at a university hospital site. Patients will be randomly divided into two groups. Both~     groups will receive sedation in the normal way. The study group will have capnography~     monitoring added. The study will look for differences in breathing between the two groups.~     Additional information regarding other aspects of monitoring will also be obtained. The~     results from the proposed study may help to improve patient safety and change current~     practice during sedation for dentistry.~   "
123649|NCT01948999|"~     The purpose of the study is to determine whether addition of electroconvulsive therapy to~     antipsychotic treatment improves the mental health of patients with treatment-resistant~     schizophrenia.~   "
123650|NCT01948986|"~     This is a study to evaluate the effect of renal impairment on the pharmacokinetics,~     pharmacodynamics, safety and tolerability of ertugliflozin in participants with type 2~     diabetes mellitus (T2DM) and in healthy participants with normal renal function.~   "
123651|NCT01948973|"~     Sacral nerve stimulation (SNS) has become a well-established treatment for patients with~     fecal incontinence since 1995. The mechanism of action of SNS is still not fully understood~     but recent studies have shown changes in both colonic motility and rectal sensibility. We~     have previously shown IBS patients to benefit from sacral nerves stimulation. With the~     present study, we aim to evaluate if subsensory sacral nerve stimulation is as effective as~     suprasensory sacral nerve stimulation.~   "
123652|NCT01948960|"~     A study to determine whether everolimus pharmacokinetics in elderly and obese patients is~     different compared to control patients.~      Furthermore the investigators will investigate the relation between metabolic response~     assessed with [18F] Fluorodeoxyglucose-Positron Emission Tomography (FDG-PET) and everolimus~     exposure and clinical benefit.~      The investigators will explore whether dose escalation in patients who are hypothetically~     underexposed will result in an increase in metabolic response.~   "
123653|NCT01948947|"~     Due to recent wars in Afghanistan and Iraq, the number of Veteran suffering from Mild~     traumatic brain(MTBI) injury and PTSD increases rapidly. Headache is one of the most~     debilitating clinical symptoms in Veteran with MTBI and the cause of it is still not entirely~     clear. Recently, the use of non-invasive brain stimulation such as repetitive transcranial~     magnetic stimulation(rTMS) has yielded favorable clinical outcome in a few intractable~     chronic central pain conditions including headaches. This study aims to 1) assess the effect~     of rTMS in relieving headache and improving neurophysiological functions; and 2)explore the~     neuronal mechanisms associated with MTBI related headache and the analgesic effect of rTMS~     with function magnetic resonance imaging (fMRI).~   "
123654|NCT01948934|"~     The purpose of this study is to determine the safety of use of a new therapeutic strategy for~     the treatment of patients with large wounds~   "
123655|NCT01948921|"~     Our pilot results showed that meperidine reduce patient discomfort during EGD~     (esophagogastroduodenoscopy). But many patients can tolerate EGD well without any sedative~     agents. So the investigators target the use of meperidine on patients expected to have poor~     tolerance in this study, which includ young females with high anxiety level and patients with~     prior poor tolerance. The investigators test the hypothesis that meperidine improves~     tolerance and alleviates discomfort for patients expected to have poor tolerance during~     diagnostic EGD.~   "
123656|NCT01948908|"~     The purpose of this study is to determine exactly how much drug volume should be administered~     into each nare, so that the drug absorption can be maximized and the amount that runs out of~     the nose, or is swallowed, is minimized, thereby optimizing the effectiveness of any drug~     given intranasally. The investigators will determine this ideal volume of administration by~     studying intranasal midazolam in children who require sedation to facilitate laceration~     repairs. The investigators will evaluate both clinical outcomes as well as pharmacokinetic~     outcomes associated with each volume of administration. We will block randomize children to~     receive intranasal midazolam in maximum aliquots of one of the three following VOA: 200~     microliters (mcL), 500 mcL, or 1000 mcL.~   "
123657|NCT01948895|"~     This multi-centred study will be conducted at two centres. The design will be an open label,~     flexible-dose study. This investigation will evaluate the efficacy of Desvenlafaxine~     monotherapy for patients who meet diagnostic criteria for dysthymia.~   "
123658|NCT01948882|"~     The Essure System is indicated for women who desire non-incisional permanent birth control~     (female sterilization) by occlusion of the fallopian tubes. The objective of the study is to~     evaluate the safety and effectiveness of the Essure System (Model ESS505) for permanent birth~     control in preventing pregnancy. The Essure ESS505 System includes a design modification that~     will be studied to determine if it provides immediate birth control, thereby removing the~     three months waiting period required for the commercially available Essure System Model 305~     to be effective.~   "
123659|NCT01948869|"~     The study shall explore whether treatment of atopic dermatitis is equally effective with~     respect to a marketed medical device and a new medical device.~   "
123660|NCT01948856|"~     The purpose of this study is to assess the efficacy and safety of J022X ST for prevention of~     Recurrent Upper-Respiratory Tract Infections (RURTI) compared to placebo in children of~     younger age who develop infectious diseases more frequently than other children of this age~     in general.~   "
123661|NCT01948843|"~     Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from~     microbes that degrade arginine. ADI has been formulated with polyethylene glycol, and has~     been used to treat patients that have cancers that require arginine. In this study, ADI will~     be combined with the well known chemotherapy Doxorubicin and the safety and potential~     efficacy of this combination will be explored in patients with HER2 Negative Metastatic~     Breast Cancer.~   "
123662|NCT01948830|"~     This study was designed to evaluate the efficacy and safety of two different regimens of 0.5~     mg ranibizumab given as intravitreal injection in patients with neovascular age-related~     macular degeneration~   "
123666|NCT01948778|"~     Septic shock has a high mortality risk despite the availability of various treatments.~     Endotoxin, that is present in the cell walls of gram-negative bacteria, is a potent trigger~     of innate immunity. Endotoxin leads to an activation of a cascade with an overwhelming~     systemic overflow of pro- and anti- inflammatory mediators at the early phase of sepsis with~     generalized vascular endothelial damage, tissue injury and multi-organ failure.~      Extracorporeal blood purification therapies aim to reduce the circulating level of endotoxin.~     Different extracorporeal blood purification systems are available. The oXiris™ device~     comprises a surface treated AN69 membrane capable to adsorb a large spectrum of plasma~     cytokines, such as IL-6 and HMGB1 protein. The positively charged inner surface of the~     membrane allows absorbing negatively charged bacterial products such as endotoxin. From an~     historical perspective, filters containing AN69-based membranes have been the most commonly~     used products for CRRT in the management of critically ill patients and a substantial volume~     of published data exist.~      Another extracorporeal endotoxin removal therapy is the hemoperfusion with ToraymyxinTM (PMX)~     filter, which is a cartridge selectively removing blood endotoxin. PMX is composed of~     polymyxin B covalently bonded to polystyrene-derivative fibres. It is well known that the~     polarity of the polymyxin B antibiotic binds endotoxin and has bactericidal activity.~     Therefore, the rationale underlying extracorporeal therapy with PMX is to remove circulating~     endotoxin by adsorption.~        -  Trial with medical device~   "
123667|NCT01948765|"~     The investigators hypothesize that the application of 30% xenon as an adjuvant to general~     anesthesia with a target-controlled infusion of propofol is superior to general anesthesia~     with propofol alone with respect to hemodynamic stability.~   "
123668|NCT01948752|"~     The current study sought to examine the effect of menu labeling on food ordering and food~     consumption, including the effect of displaying calories along with other nutrients, such as~     sodium, fat, and sugar, as well as in different formats, such as traffic lights.~      The investigators hypothesize significant differences in the calorie amount of menu~     selections and food consumption across experimental conditions. The investigators anticipate~     that calorie amounts will be significantly higher in the no calorie information) compared to~     each of the other 3 conditions, and significantly lower in the Traffic Light conditions~     compared to calories only condition.~      2) Individuals in Condition 1 (no calorie information) will be significantly more likely to~     underestimate the calorie content of their meals compared to individuals in the intervention~     conditions.~   "
123669|NCT01948739|"~     The purpose of this study is:~        1. To augment the MAHI Exo-II, a physical human exoskeleton, with a non-invasive brain~          machine interface (BMI) to actively include patient in the control loop and thereby~          making the therapy 'active'.~        2. To determine appropriate robotic (kinematic data acquired through sensors on robotic~          device ) and electrophysiological ( electroencephalography- EEG based) measures of arm~          motor impairment and recovery after stroke.~        3. To demonstrate that the BMI controlled MAHI Exo-II robotic arm training is feasible and~          effective in improving arm motor functions in sub-acute and chronic stroke population.~   "
123670|NCT01948726|"~     Hypofractionation with simultaneous integrated boost has been investigated in a few trials~     and appears to be safe and feasible with less lung toxicity in smaller studies.~      Investigators initiated this multicenter phase II prospective trial to analyse acute toxicity~     of hypofractionation with simultaneous integrated boost in patients with early breast cancer~     under the hypothesis that the ratio of patients with acute radiogenic toxicity Grad II~     according NCI-CTCAE amounts maximum 20%.~   "
123671|NCT01948713|"~     INTRODUCTION: Stress urinary incontinence is a common condition in women and can be defined~     as the involuntary loss of urine on exertion, exercise, sneezing or coughing. This pathology~     causes physical discomfort and impacts the quality of life in a negative manner.~     Physiotherapeutic exercises is a treatment with low cost and high patient attendance. It can~     be applied with focus on strengthening the pelvic floor muscles or on muscular synergism.~     OBJECTIVE: To compare the effectiveness of Kegel exercises performed alone or performed in~     association with the strengthening of the muscles of the hip in the treatment of stress~     urinary incontinence. METHODOLOGY: The study is a randomized, blinded clinical trial. It aims~     at assessing objectively the strength of the pelvic floor, the improvement in the number of~     episodes of loss and impact on quality of life. The study will accept up to 40 women, who~     will be divided into two groups of physical therapy: group 1 (that will strengthen the pelvic~     floor muscles with Kegel exercises) and group 2 (that will perform strengthening the pelvic~     floor muscles with Kegel exercises associated with the strengthening of muscles of the hip).~     The two groups will be evaluated at the beginning and at the end of treatment.~   "
123672|NCT01948700|"~     Hispanic adolescents experience more severe alcohol-related consequences due to their alcohol~     abuse and yet significantly fewer Hispanic adolescents receive alcohol treatment,~     particularly among justice-involved youth. Despite the level of research that has been~     conducted on motivational interviewing (MI) with mainstream samples, no published studies~     have investigated the efficacy of this brief, individual intervention with Hispanic~     adolescents. The overarching objective of this application is to evaluate the efficacy of a~     brief individual intervention (MI) for problem drinking behaviors with a sample of~     justice-involved Hispanic and Caucasian adolescents to determine if this intervention is~     differentially effective between Hispanic and Caucasian adolescents. Specifically, the first~     aim is to determine whether an MI intervention targeting alcohol abuse is effective at~     reducing alcohol use and related risk behavior in a sample of adolescent alcohol abusers. The~     second aim is to examine whether the effects of MI on problem drinking outcomes (e.g.,~     alcohol problems, quantity of drinking, frequency of binging) are different between Hispanic~     versus Caucasian adolescents. Because it is important to determine the mechanisms that~     mediate the effects of MI and determine whether these mechanisms differ between Caucasian and~     Hispanic adolescents, the third aim is to examine whether group (Hispanic vs. Caucasian)~     moderates the mediational linkages in the overall model using a cross-groups approach to~     moderated mediation. To accomplish these aims, 453 Caucasian and Hispanic justice-involved~     alcohol abusing adolescents (ages 14-17) will be randomized to either two 60 minute MI~     interventions (one at baseline and a second, one week later) or an education condition. All~     adolescents will receive behavioral assessments at baseline, 3, 6 and 12 months. The proposed~     research is expected to take a significant step towards reducing current racial/ethnic health~     disparities in alcohol treatment for Hispanic adolescents.~   "
123673|NCT01948687|"~     AIM To evaluate the role of real time elastography (ARFI and Hitachi elastography) in~     noninvasive diagnosis of liver fibrosis in patients with chronic hepatitis~   "
123674|NCT01948674|"~     The purpose of this study is to see if computer tasks that challenge the brain (cognitively~     stimulating tasks) can improve memory and other types of thinking in adolescents and young~     adults who are being treated for substance use problems. The study will compare the effects~     of different versions of the computer tasks.~   "
124304|NCT01940471|"~     The primary objective of this study is to compare the efficacy, safety, and tolerability of~     tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive and~     treatment-experienced adults with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B~     virus (HBV) infection.~   "
123675|NCT01948661|"~     Colonic adenomatous polyps are pre cancer lesions and are used as intermediate markers for~     testing agents with potential cancer prevention.~      Meriva© is a bioavailable form of curcumin, a polyphenolic compound obtained from turmeric~     (Curcuma longa L.) endowed with anti-inflammatory, antioxidant and antitumor effects. In vivo~     data indicate that curcumin formulated with phosphatidylcholine furnishes higher blood levels~     of parent agent than natural curcumin.~      Mirtoselect©, an anthocyanin mixture from bilberry containing isolated cyanidin-3-glucoside~     (C3G), the most abundant anthocyanin in diet, prevents intestinal adenoma formation in the~     Apc(Min) mouse model.~      The investigators hypothesize that the combination of both agents will decrease the~     expression of proteins involved in colon tumorigenesis relative to placebo.~      The change of biomarker expression between pre-treatment biopsy and post-treatment endoscopic~     resection in the target adenoma and the normal rectal mucosa will be the response measures.~      The primary response measure is the change of immunohistochemical (IHC) expression of~     β-catenin in adenomatous tissue and normal rectal mucosa. Secondary response measures are the~     changes of IHC Nuclear Factor-Kβ (NFKβ), cell proliferation by Ki-67 Labeling Index and~     apoptosis by P53 in adenomatous and adjacent normal mucosa.~      The study design is a phase II, randomized, double blind, placebo controlled, window of~     opportunity trial of the combination of Mirtoselect 1 gr/day+Meriva 1 gr/day or placebo.~     Subjects with histological confirmation of colorectal adenomatous polyps >1 cm not suitable~     to immediate complete removal will be enrolled in a 4-week intervention trial before~     endoscopic polypectomy.~      The demonstration of a biological activity of the two agent combination may provide the~     rationale for a phase III trial aimed at reducing the risk of colon cancer in high risk~     subjects.~   "
123676|NCT01948648|"~     If treatment of colesevelam, fish oil in conjunction with ezetimibe, will lead to further~     reduction in plasma plant sterol levels in sitosterolemia patients. We hypothesize that~     treatments with fish oil, colesevelam and ezetimibe will maximize decrease in plasma~     concentrations of sitosterol and other plant sterols in sitosterolemia patients.~   "
123677|NCT01948635|"~     The investigators hypothesized that PVC tapered-cuff tracheal tubes would reduce~     microaspiration of gastric content as determined by pepsin level in tracheal aspirate.~   "
123678|NCT01948622|"~     This study evaluated the effectiveness of the Erythrina mulungu in controlling anxiety in~     patients undergoing bilateral extraction of asymptomatic, impacted mandibular third molars.~   "
123679|NCT01948609|"~     PROSper is a prospective cohort study of 100 women 35-50 years of age with BRCA 1/2 mutations~     who have elected to either undergo risk reducing salpingo-oophorectomy (RRSO) or nonsurgical~     management. The investigators will compare the change in cardiovascular health, bone health,~     sexual function, quality of life, and menopausal symptoms over 3 years of follow-up between~     women who undergo RRSO (baseline just prior to surgery) and age-matched controls that do not~     undergo RRSO.~      The investigators hypothesis is that women who undergo a premature surgical menopause induced~     by RRSO have worse cardiovascular health and bone health compared with women who do not~     undergo RRSO.~   "
123680|NCT01948596|"~     The present study aims to examine the efficacy and safety of omega-3 polyunsaturated fatty~     acids for pregnant women with depressive symptoms.~   "
123681|NCT01948583|"~     Aim of the study is to evaluate the humectant activity and the local tolerability of a new~     formulation of Gynomunal® vaginalgel in menopausal women (menopause since at least 2 years)~     with referred vaginal dryness~   "
123682|NCT01948570|"~     Primary end point of the study is the clinical and non-invasive instrumental evaluation of~     the activity of P-3075 cream on subjects with acne: 20 subjects with a mild/moderate grade~     and 20 subjects with a moderately severe/severe grade, according to Cunliffe' classification.~      Secondary end-points are the cosmetic acceptability and efficacy evaluation by the volunteers~     and the local tolerability assessed by the investigator and the subjects.~   "
123683|NCT01948557|"~     Short courses of drugs can be given to HIV-infected pregnant women to reduce the chance of~     HIV infection being passed to her child either during pregnancy or during the labour process.~     However, children can also become infected by drinking the mother's breastmilk which contains~     the HIV virus. In many poor, developing countries in Africa, breastfeeding is the normal way~     of infant feeding and is vitally important because of the protection it gives to children~     from other diseases such as diarrhoea and malnutrition. Ideally there would be a way to make~     breastfeeding safer from HIV transmission without losing its other advantages.~      A medical study recently suggested that HIV-infected women who exclusively breastfed their~     children i.e. gave breastmilk but without any water, tea, formula milk or any solid foods did~     not pass on the virus to their children to the same degree as women who MBF with these other~     fluids and foods. It is important to confirm whether this observation is in fact true or not.~     We hypothesize that exclusive breastfeeding by HIV-infected mothers carries a lower risk of~     HIV transmission than mixed breastfeeding.~      We propose to follow 2,100 HIV-infected pregnant women and also some HIV-uninfected women~     from the time that they book at the clinic until 24 months of age. HIV-infected women who say~     they intend to breastfeed and all the HIV-uninfected women will be visited at their homes by~     breastfeeding counsellors both before and after delivery to support exclusive breastfeeding.~     HIV-infected women who choose not to breastfeed will be helped by clinic staff to safely~     replace all breastmilk with some other milk. An independent team will visit all mothers at~     their homes and collect information about the way they feed their children. Blood samples~     will be collected from the children at different times by a simple heel prick and the blood~     stored on a piece of filter paper. By testing these samples and comparing with the type of~     feeding at that time, we will be able to see when a child becomes infected and whether~     exclusive breastfeeding gives any protection.~   "
123684|NCT01948544|"~     -  Evaluate subjects in an prospective observational study~        -  Subjects will be administered scientifically validated questionnaires~        -  Determine the affect of the Portable Oxygen Concentrator (POC) on improvements in:~             1. Exercise capability, dyspnea and quality of life as primary endpoints~             2. Utilize:~                  1. Baseline Dyspnea Index (BDI)~                  2. Transitional Dyspnea Index (TDI)~                  3. Chronic Respiratory Disease Questionnaire (CRQ)~                  4. Six minute walk test (6MWT)~                  5. Epworth Sleepiness Scale (ESS)~        -  The secondary endpoints will be:~             1. Rate of exacerbations, sleep quality~             2. Health care utilization (emergency room encounters, hospital admissions)~   "
123685|NCT01948531|"~     Aim of the study is to evaluate clinically and by non-invasive instrumental evaluations the~     antiage activity of Gynomunal® gel after one single application on the face (short term~     evaluation) and 4 weeks of repeated use twice daily (long term evaluation) by healthy female~     volunteers.~      It is also aim of this study to evaluate cosmetic acceptability by the volunteers and~     efficacy and tolerance both by investigator and volunteers.~   "
123686|NCT01948518|"~     The purpose of this study was to investigate the acute effects of sildenafil on diffusion~     capacity, a commonly performed pulmonary function test, which is used to assess the lungs'~     gas exchange capability.~      This study does not assess safety or efficacy of the drug. The study does not have clinical~     end points. The variables studied are diffusion capacity and 6 minute walk after a single~     dose of sildenafil.~      This study has been completed.~   "
123687|NCT01948505|"~     To assess the efficacy of an intravenous nonnarcotic pain medication on controlling patient~     pain.~      To assess the effect of an intravenous nonnarcotic pain medication on patient sedation levels~     in neurocritically ill patients.~      To assess the effect of an intravenous nonnarcotic pain medication on common side effects~     seen in patients taking other intravenous narcotic pain medication in the neurocritical care~     unit.~   "
123688|NCT01948492|"~     Minimal data are available on protein requirements throughout the lifespan. Currently~     available recommendations are based on nitrogen balance data. The limitations of the nitrogen~     balance method have been well described. Importantly, nitrogen balanced underestimates~     requirements.~      The current dietary reference intake (DRI) requirement for healthy adult males is based on~     the reanalysis of the nitrogen balance date from Young and Scrimshaw. This data was~     reanalyzed statistically by Rand et al. and he concluded that the protein requirement of~     healthy adults was 0.65 and 0.83 (mean and RDA) g/kg/day of good quality protein. Using IAAO,~     our group estimated the protein requirement of young men (mean age 27 years) to be 0.93 and~     1.2 g/kg/day (mean and RDA).~      Currently there are no studies on protein requirement in the elderly. In a recent nutrition~     survey conducted by national health and nutrition examination survey (NHANES), the authors~     concluded that adults between the ages of 51 - 70 years old consumed an average on 1.0~     g/kg/day (ideal body weight) of protein which represents about 15 % of calories. Depending on~     the calculations used for ideal body weight some older adults could be getting higher or~     lower than requirement. There is no scientifically derived protein estimate for older adults.~     Therefore there is a need to measurer protein requirement in that population.~      The goal of this study therefore is to measure the protein requirement of male elderly~     subjects > 75 years using the indicator amino acid oxidation (IAAO) technique.~      Hypothesis:~      The investigators hypothesize the protein requirement in elderly male subjects will be lower~     (0.85-1.05 g/kg/day) than that established in young healthy males ( 0.93 - 1.2g/kg/day).~   "
123689|NCT01948479|"~     Insoles are designed to reduce increased loads and re-ulceration risk in patients with~     diabetes. The investigators previous research findings suggest that an instant insole~     solution may benefit some, but effectiveness is difficult to predict. The investigators~     propose a feasibility study using in-shoe pressure analysis to optimise the protective effect~     of insoles and footwear with the aim of reducing re-ulceration rates.~      Early indications from exploratory case studies within the real world clinical setting~     suggest that by implementing the investigators previous published research findings the~     investigators can optimise effectiveness and reduce outcome variability of protective~     footwear and insoles provided to patients at risk of re-ulceration.~      However a further randomised control trial is necessary to evaluate the effectiveness of~     in-shoe pressure analysis in reducing re-ulceration rates within the NHS setting. The~     proposed feasibility study will recruit 20 participants from the multidisaplinary diabetic~     foot clinic Derriford Hospital and allocate them to either 1) Routine insoles and footwear~     provision or 2) Routine insole and footwear provision, and temporary insole provision with~     optimisation. The findings from the feasibility study will inform protocol development for a~     larger clinical trial. The results of the feasibility study will be used to strengthen a~     protocol for a grant application to conduct the main RCT. A secondary output from the pilot~     study will be the dissemination of findings in a peer reviewed journal and at conference.~   "
123690|NCT01948466|"~     The overall goal of this project is to learn how positive advertising messages impact school~     food choices. More specifically, this study will determine if positive video messages about~     fruits and vegetables delivered during the elementary school morning news program can~     influence children to select more fruits and vegetables in a school lunch setting.~     Additionally, it will determine if assessing food selection is representative of food~     consumption by children in a school lunch room setting.~   "
123691|NCT01948453|"~     The purpose of this study is to determine whether garlic in adjunct to conventional medical~     treatment is effective in improving carotid intima media thickness (CIMT), Flow mediated~     dilation (FMD) and plasma lipid profile or c-reactive protein of coronary artery disease~     (CAD) patients.~   "
123692|NCT01948440|"~     Making referrals to medical and psychosocial services for substance abuse clients has proven~     difficult due to lack of access to services, inadequate counselor knowledge, and lack of~     motivation and skills among clients. Inflexxion is proposing the development of ASI-MV~     Solutions, which will educate clients about employment, legal, psychiatric, relapse~     prevention, medical, and family issues, as well as include resources and strategies for~     counselors. By linking learning modules to client results on the ASI-MV, an online~     interactive version of the ASI administered in treatment settings, we will be able to offer~     clients important tools to address key recovery issues and encourage counselors to make~     appropriate referrals to medical and psychosocial services.~   "
123693|NCT01948427|"~     THRIVE is an observational study that will collect information on patients with UCDs. THRIVE~     will follow enrolled participants for up to 10 years. As an observational study, enrolled~     patients will not be required to make any additional office visits or take any medicine~     outside of normal care.~   "
123694|NCT01948414|"~     The P300 is one of the cognitive wave of the Event-Related Potential (ERP) that is used to~     investigate the cognitive process. The P300 component are accepted as electro-physiological~     markers of neuropsychiatric disorders like alcoholism or drug addiction.~      Recent scientific data suggest that eating disorders, leading to weight gain and obesity,~     will be similar of those of drug addiction: it is the incentive sensitization theory that~     implicates the dopaminergic reward system.~      The aim of this cross-sectional study is to investigate the alteration of P300 auditory ERP~     in obese women with eating disorders in comparison with obese and lean women without eating~     disorders.~   "
123695|NCT01948401|"~     This interventional, open study will evaluate clinical data in relation to biomarkers in~     patients 12 to 75 years of age with severe oral corticosteroid (OCS) - dependent asthma.~     Patients with uncontrolled asthma will be offered an additional escalation of OCS at a dose~     of 0.5 mg/kg for 7 days. Patients enrolled in this study would be eligible to be enrolled in~     a future placebo-controlled intervention study designed to measure the steroid-sparing effect~     of lebrikizumab.~   "
123696|NCT01948388|"~     The purpose of the study is to evaluate the effect of the utilization of two doses of~     corticotrophin ( ACTH) as a treatment in patients with early onset rheumatoid arthritis as an~     alternative to conventional steroid therapy by evaluating the change from baseline in the~     clinical findings as well as the structural findings on Magnetic Resonance Imaging (MRI).~     Corticotrophin (ACTH) may prevent the well documented structural progression damage in RA~     patients using disease-modifying antirheumatic drug (DMARD) therapy alone.~   "
127447|NCT01899222|"~     Assessment of handheld fundus images in comparison to conventional fundus camera images.~   "
123699|NCT01948349|"~     The advantage of self-ligating brackets on periodontal health has yet to be determined. In~     addition, the utilization of tongue scraping as an adjunct to traditional oral hygiene~     measures has yet to be studied in orthodontic patients. The aim of this study is to evaluate~     the effect of bracket type on plaque accumulation and also the impact of the appliance on~     oral malodor. In addition, the effect of tongue scraping on halitosis will be studied in~     patients undergoing orthodontic treatment. We hypothesize that self-ligating brackets will~     harbor less plaque than normal brackets, that tongue scraping will significantly decrease~     halitosis in patients undergoing orthodontic treatment and that patients with self-ligating~     brackets will exhibit less halitosis as measured by halimeter.~   "
123700|NCT01948336|"~     The aim of this study is to evaluate the effect of dexmedetomidine infusion on early stage~     renal function.~   "
123701|NCT01948323|"~     The purpose of this study is to investigate whether overweight but not obese pregnant African~     women having unlimited access to a health education-information technology (IT) based~     intervention package gain weight within the acceptable range of 8-12 kg during the pregnancy~     period.~      Therefore, we hypothesize that unlimited access to health education via an IT-based~     intervention package has the potential to reduce the onset of obesity in African pregnant~     women.~      To date (Aug 2015), 95% of patients have been recruited, 1320 potential subjects have been~     screened and 150 enrolled into the study~   "
123702|NCT01948310|"~     The primary objective is to assess whether the increased angina threshold on ranolazine and~     subsequent higher training intensity will result in improved exercise tolerance and oxygen~     consumption; and greater than that observed with exercise training on placebo. The study team~     anticipates the chronic exercise improvements with ranolazine will be incrementally higher~     than the acute effects provided by ranolazine alone and demonstrated in previous trials. Key~     secondary objectives include the acute ranolazine and chronic exercise plus ranolazine~     effects on total daily energy expenditure (TDEE) and angina-related quality of life.~   "
123703|NCT01948297|"~     This study is primarily designed to assess the safety and the tolerability of Debio1347~     (CH5183284) in patients with advanced solid malignancies, whose tumours have an alteration of~     the Fibroblast Growth Factor Receptor (FGFR) 1, 2 or 3 genes, for whom standard treatment~     does not exist or is not indicated.~      The main objective of Part A is to identify the dose-limiting toxicities (DLTs) and estimate~     the maximum tolerated dose (MTD) based on the safety and tolerability of Debio1347 orally~     administered daily to these patients, in order to determine the recommended dose.~      The main objective of Part B is to evaluate the safety profile at the recommended dose, in a~     larger cohort of these patients.~   "
123704|NCT01948284|"~     This prospective, randomize, controlled trial will compared maximal to half-maximal suction~     pressure applied during water exchange in patients undergoing minimally sedated colonoscopy.~     We test the hypothesis that maximal suction pressure is more efficient and causes shorter~     insertion time.~   "
123705|NCT01948271|"~     The purpose of this research study is to better understand whether trichuris suis ova (TSO)~     ingested orally may be safe and effective in the treatment of psoriasis.~   "
123706|NCT01948258|"~     This study will assess the use of the new Clearblue Advanced Fertility Monitor for one~     menstrual cycle in a home setting by female volunteers seeking to get pregnant.~   "
123707|NCT01948245|"~     The purpose of the investigation is to compare two catheter lock solutions (TaurolockTMHep100~     and Heparin 100 IE/ml), on the occurence of catheter related blood stream infection, in~     patients with intestinal failure and a central venous access device for home parenteral~     nutrition.~   "
123708|NCT01948232|"~     The purpose of this study is to evaluate the feasibility of conducting a medical intervention~     trial in childhood cancer survivors with early echocardiographic evidence of cardiac~     remodeling.~   "
123709|NCT01948219|"~     The objective of this clinical study is to evaluate the feasibility, safety and efficacy of~     the ENTegral Artificial Larynx (AL) in patients indicated for total laryngectomy.~   "
123710|NCT01948206|"~     The purpose of the study is to determine whether prolonged paced QRS duration is a marker of~     sudden cardiac death in subjects with implantable cardioverter-defibrillators (ICD).~   "
123711|NCT01948193|"~     The purpose of this study is to describe the immunogenicity and safety of a novel DTaP- IPV-~     Hep B-PRT~T fully liquid combined hexavalent vaccine (Hexaxim™) administered at 6, 10 and 14~     weeks of age in infants born to mothers documented to be serum anti-hepatitis B surface~     antigen (HBsAg) serology negative in India.~      Primary Objective:~        -  To evaluate the immunogenicity of the study vaccine in terms of seroprotection~          [diphtheria toxoid, tetanus toxoid, poliovirus types 1, 2 and 3, Haemophilus influenzae~          type b (Hib) polysaccharide (PRP), hepatitis B (Hep B)] and vaccine response for~          pertussis antigens [pertussis toxoid (PT) and filamentous haemagglutinin (FHA)] one~          month after the third dose.~      Secondary Objectives:~        -  To further describe the immunogenicity of the study vaccine, before the first dose and~          one month after the third dose.~        -  To describe the safety after each and any doses of the study vaccine.~   "
123712|NCT01948180|"~     To investigate the efficacy of autologous EBV-specific T-cells for the treatment of patients~     with aggressive EBV positive extranodal NK/T-cell lymphoma~   "
123713|NCT01948167|"~     Investigators will combine risk factor research and evidence-based prevention programs, to~     advance knowledge on personalized approaches to prevention that may be able to better bend~     trajectories of depression that surge throughout adolescence.~   "
123714|NCT01948154|"~     Cerebral palsy (CP) encompass a group of non-progressive, non-contagious motor conditions~     that cause physical disability in human development. It is not infrequently to note~     concurrent impairment in sensory, intelligence, vision and auditory in those patients. Many~     studies have documented Cerebral palsy is associated with a variety of neuromotor disorders~     that frequently affect the speech production system. The speech function impairment varied~     widely due to different severity of diseases involved. The investigators hypothesize such~     impairment of speech function may affect degree of social participation and eventually the~     quality of life (QoL).~   "
123715|NCT01948141|"~     This phase II trial studies how well nintedanib works in treating patients with advanced~     non-small cell lung cancer who have failed up to two previous chemotherapy regimens.~     Nintedanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth.~   "
123717|NCT01948115|"~     The variety of breech presentation at term is about 3-4% of all births. Our study aims to~     assess the value of using an equimolar mixture of oxygen and nitrous oxide. Indeed, in some~     patients algic or relaxed, the success rate seems more important.~      It's a single blind prospective randomized controlled study, comparing success rate of ECV~     after an equimolar mixture of oxygen and nitrous oxide or placebo (medical air).~      We need to include 150 patients (75 in each arm), for a period of 2 years. After ECV, we will~     give the patient a satisfaction questionnaire. We compare the success rate of ECV as primary~     outcome.~   "
123718|NCT01948102|"~     The purpose of the project is to obtain skin and adipose tissue samples from patients with~     ALS to develop new diagnostic and prognostic markers of the disease. These samples will be~     obtained when percutaneous endoscopic gastrostomy (PEG) is performed as part of their~     standard of care. Skin and adipose tissue samples will also be obtained from disease control~     subjects who require a PEG as part of their standard of care.~   "
123719|NCT01948089|"~     This project will investigate the effectiveness of an intensive and focused working memory~     training program for chronic stroke patients. The investigators hypothesize that working~     memory training will be an effective method of improving working memory and related cognitive~     and behavioural functions in this population.~   "
123720|NCT01948076|"~     The 40 resident study subjects will be randomized to either receive a training session on use~     of a pocket-sized ultrasound or to receive training on physical exam skills. Following these~     sessions the subjects will have the opportunity to practice their skills during clinical~     rounds at BWH inpatient and outpatient settings. Four weeks after the training session all~     study subjects will take part in an assessment of their diagnostic skills. During this~     assessment they will be asked to complete an exam on a patient subject. Those randomized to~     the ultrasound group will be allowed to use their devices while the control group will use~     the traditional physical exam. Following the exams, resident study subjects will be asked to~     indicate whether they detected any of the following abnormalities on their exams: pleural~     effusion, hepatomegaly, cirrhotic liver, splenomegaly, ascites, aortic stenosis, mitral~     regurgitation, right atrial pressure, abdominal aortic aneurysm, deep vein thrombosis.~     Resident study subjects will also complete a questionnaire about the physical exam and use of~     the ultrasound. Prior to the assessment, all patients will undergo ultrasound by an attending~     radiologist, and these results will serve as the gold standard for our study.~   "
123721|NCT01948063|"~     This study aims to determine if Ubiquinol (reduced form of COQ10) will attenuate~     mitochondrial injury and decrease inflammatory response in patients suffering from sepsis.~   "
123722|NCT01948050|"~     This is a pilot study designed to collect preliminary data on safety and efficacy of~     transcranial direct current stimulation (tDCS) to relieve pain in cancer patients who~     developed neuropathic pain in the affected area after a surgical intervention, radiation~     therapy, or chemotherapy to treat the disease.~   "
123723|NCT01948037|"~     The purpose of the study is to investigate whether the hydrotherapy are effective in against~     pain and other symptoms in diabetes-induced LEAD.~   "
123724|NCT01948024|"~     This is a Multiple-dose, steady state, three-way reference-replicated crossover study.~      The purpose of this Study is to determine the bio-equivalence between SAPHRIS and Asenapine~     10mg sublingual tablets.~   "
123725|NCT01948011|"~     To investigate the Racecadotril pharmacokinetic linearity after single oral administration of~     10, 30 and 60 mg as a suspension.~      To evaluate the comparative bioavailability of the new Racecadotril formulation (suspension)~     versus the reference sachet formulation (granules)~   "
123726|NCT01947998|"~     This prospective cohort study will provide information about: characteristics of Rivaroxaban~     use in patients who are prescribed Rivaroxaban for the first time compared to patients who~     are prescribed Warfarin for the first time, the occurrence of intracranial haemorrhage,~     gastrointestinal and urogenital bleeding, and the occurrence of non-infective liver disease.~   "
123727|NCT01947985|"~     This prospective cohort study will provide information about: characteristics of Rivaroxaban~     use in patients who are prescribed Rivaroxaban for the first time compared to patients who~     are prescribed Acenocoumarol for the first time, the occurrence of intracranial haemorrhage,~     gastrointestinal and urogenital bleeding, and the occurrence of non-infective liver disease.~   "
123728|NCT01947972|"~     Neonatal nutrition has to face a contradictory and conflicting nutritional regimen like a~     high percentage of amino acids from the first day of life in order to achieve normal~     neurodevelopment versus metabolic complications (insulin resistance, hyperglycemia, increased~     visceral fat) that this type feeding, in conjunction with complexity of prematurity, is~     likely to cause. Current study aims to investigate is whether individualized fortification of~     breast milk protein, based on the mother's milk protein content and targeting the recommended~     daily protein requirements, is associated with better nutrition, growth, biochemical and~     endocrine markers associated with the nutrition of preterm low birth weight neonates,~     compared to the standard fortification of human milk.~   "
123729|NCT01947959|"~     This prospective cohort study will provide information about: characteristics of Rivaroxaban~     use in patients who are prescribed Rivaroxaban for the first time compared to patients who~     are prescribed Phenprocoumon for the first time, the occurrence of intracranial haemorrhage,~     gastrointestinal and urogenital bleeding, and the occurrence of non-infective liver disease.~   "
123730|NCT01947946|"~     The purpose of this study is to determine whether Benralizumab reduces the number of asthma~     exacerbations in patients who remain uncontrolled on medium doses of ICS-LABA.~   "
123731|NCT01947933|"~     The main purpose of this study is to evaluate the safety of the study drug known as~     mirikizumab. The study will investigate how the body processes the study drug and how the~     drug affects the body. The study will last about 3 months for each participant.~   "
123732|NCT01947920|"~     The purpose of this study is to determine the safety and tolerability profile of tramadol~     hydrochloride (HCl) given as oral doses every 6 hours, within the range of dosages supported~     by currently available toxicology and clinical data (200 mg to 600 mg per day).~   "
123977|NCT01944722|"~     The purpose of the study is to compare the results of the Becton Dickinson (BD) Onclarity™~     Human Papilloma Virus (HPV) Assay on the BD Viper™ LT instrument from liquid-based cytology~     (LBC) media diluted in BD HPV LBC diluent to adjudicated histology results from biopsy and a~     molecular composite comparator.~   "
123733|NCT01947907|"~     A six month study of ACP-001, a long-acting growth hormone product, versus standard human~     growth hormone therapy. ACP-001 will be given once-a-week, standard human growth hormone~     (hGH) will be given on a daily basis. The primary aim is to demonstrate safety,~     pharmacokinetics and pharmacodynamics over a period of six months. A secondary objective is~     the comparison of height velocity (HV) of the ACP-001 treated groups to the daily hGH~     treatment group.~   "
123734|NCT01947894|"~     The purpose of this study is to assess the long term treatment outcomes of Growth Hormone~     treatment in patients who are prescribed and treated with Genotropin. Also, plan to determine~     the relationships between clinical status, dosage schedule and response to Genotropin~     treatment.~      This study will also contribute to our knowledge of adult Growth Hormone Deficiency,~     including transition period in Childhood Onset Growth Hormone Deficiency and its treatment.~   "
123735|NCT01947881|"~     The purpose of this study is to identify Diabetic Macular Edema (DME) characteristics in eyes~     that show different response to treatment with anti-VEGF (vascular endothelial growth factor)~     injections of Lucentis.~   "
123736|NCT01947868|"~     This is an open-label, non-interventional, single-arm, multicenter study in a real-world~     population to assess the clinically symptom improvement and quality of life (QoL) in patients~     with locally advanced or metastatic NSCLC and positive EGFR mutation who receive EGFR-TKIs as~     the first-line treatment.~      The Primary Objective is to estimate symptom improvement rates in patients with locally~     advanced or metastatic NSCLC and positive EGFR mutation who receive EGFR-TKIs as the~     first-line treatment. A clinically meaningful improvement is defined as an increase from~     baseline of 2 or more points for LCS (Lung Cancer Scales) at Week 4.~   "
123737|NCT01947855|"~     To evaluate the efficacy of empagliflozin administered orally once daily in postprandial~     glucose and 24-hour glycaemic variability compared to placebo given for 4 weeks as~     mono-therapy in Japanese patients with type 2 diabetes mellitus with insufficient glycaemic~     control on no antidiabetic treatment.~   "
123738|NCT01947842|"~     This research study is to see if smartphone applications help college women remember to take~     birth control better than pharmacist consultation alone. Patients will participate in this~     study for 6 (six) months. The study will have two groups. Patients will be randomly assigned~     to one group or the other. The control group will be counseled by the pharmacist on the~     importance of taking birth control as prescribed. The study group will get the same~     counseling, but will also be set up to receive reminders to take medication on a smartphone~     application called Dosecast.~   "
123739|NCT01947829|"~     Session-to-session variations in delivered Kt/V that may cause failure to achieve the~     prescribed dialysis dose may be significant in regular clinical practice. To date, this is~     not recognized due to monthly blood Kt/V measurements only. Suboptimal delivery of prescribed~     dialysis dose may be caused by low effective treatment time, vascular access dysfunction,~     hemodynamic stability, blood pump speed, membrane influences, lab value variability or others~     which may vary from session to session. Patients close to recommended target limits of~     dialysis dose may thus be randomly attributed to be adequately or inadequately dialyzed.~     Therefore, in the literature, use of average Kt/V values is recommended.~      Adimea allows easy Kt/V determination in every session and thus documentation of the monthly~     achieved Kt/V in patients who repeatedly miss Kt/V. Knowledge, therefore, of~     session-to-session variability as well as knowledge of dialysis dose monitoring at every~     dialysis may enhance and secure delivery of adequate dialysis.~      The main objective is the estimation of the pooled within-patient SDs (standard deviation)~     for single treatment Adimea and of urea kinetic modeling (UKM)/ blood spKt/V. Failure of~     Kt/V>1.2 delivery as well as its potential causes will be assessed. spKt/V target achievement~     is assessed by monitoring dose by Adimea at every dialysis. This shall demonstrate that~     session-to-session variability can be decreased with usage of Adimea.~   "
123740|NCT01947816|"~     This investigation will be conducted to obtain the following information regarding the use of~     Humira 40mg Syringe 0.8mL for Subcutaneous Injection in patients with Ulcerative Colitis.~        1. Unknown adverse reactions (in particular, clinically significant)~        2. Incidence and conditions of occurrence of adverse reactions in clinical practice~        3. Factors likely to affect the safety and effectiveness~   "
123741|NCT01947803|"~     The purpose of this study will be to evaluate the safety and treatment response of~     paliperidone palmitate administered to Chinese patients with schizophrenia.~   "
123742|NCT01947790|"~     Cardiovascular complications account for the highest mortality in type 2 diabetic patients,~     mainly due to ischeamia heart disease (IHD). Most of the attention in treating IHD in type 2~     diabetes is understandably directed toward treating coronary artery conditions. However there~     are other treatable culprits in these patients.~      Left ventricular hypertrophy (LVH) is widespread in type 2 diabetic patients with IHD, even~     in the absence of hypertension. It is a strong predictor of cardiovascular events and~     all-cause mortality. In one study, the presence of LVH was a stronger predictor of mortality~     than either multivessel coronary disease or impaired left ventricular function. Regression of~     LVH has been associated with an improved prognosis, independent of change in blood pressure~     (BP). Therefore, cardiovascular events and mortality in type 2 diabetes with IHD might will~     be reduced if we can find novel therapies to regress LVH.~      Pioglitazone can improve atherosclerosis. Therefore, we hypothesied that pioglitazone can~     regress the left ventricular mass (LVM) in type 2 diabetes with IHD.Therefore, in this study,~     we will treat patients with pioglitazone, and we will also metformin as control.~   "
123743|NCT01947777|"~     To evaluate the effect of rifampin, a cytochrome P450 3A (CYP3A) inducer, on the~     pharmacokinetics (PK) of IPI-145; to assess the safety and tolerability of IPI-145 when~     administered with rifampin in healthy subjects~   "
123754|NCT01947621|"~     This is a multicenter, multinational, prospective and retrospective, observational study of~     patients with Takotsubo cardiomyopathy (TTC).~      Data on natural profile (demographical characteristics, clinical phenotype, laboratory~     values, electrocardiography parameters, echocardiography parameters, coronary angiography~     parameters, medication) and outcome are systematically collected.~      Our aim is to gain a better insight into the clinical profile and pathophysiology of TTC.~   "
123755|NCT01947608|"~     Novartis-sponsored, open-label, multi-center, interventional ETP to provide LDK378 to~     patients with ALK (+)NSCLC, who have been pre-treated with an ALK inhibitor; except in~     countries where ALK inhibitors are not approved or available. The protocol will further~     evaluate the safety of LDK378 in patients with ALK(+) NSCLC.~   "
123744|NCT01947764|"~     In the resource-limited settings where most HIV-infected children live, neither the most~     effective strategies to inform children of their HIV status, nor the impact of disclosure is~     well understood. This team's long-term goal is to provide evidence to improve the chronic~     disease management of HIV-infected children in resource-limited settings. The purpose of this~     study is to assess the effect of a patient-centered intervention guiding disclosure to~     HIV-infected Kenyan children using a randomized trial comparing the intervention to routine~     care. The primary endpoint will be probability of disclosure among children, with secondary~     endpoints of adherence, clinical outcomes, psychological distress and social outcomes. This~     work will be done within the Academic Model Providing Access to Healthcare (AMPATH) which~     currently cares for almost 120,000 adult and pediatric HIV-infected patients in 25 clinics in~     Kenya. We will utilize the excellent infrastructure of this academic partnership to provide~     the first comprehensive assessment of the physical, psychological, and social impact of~     disclosure for HIV-infected children in East Africa. We will evaluate the impact of an~     intensive disclosure intervention by pursuing these specific aims: Aim 1: Expand and modify~     an existing pediatric HIV disclosure intervention used in Kenya to include patient-centered~     components; Aim 2: Perform a randomized trial to compare the impact of clinic implementation~     of the culturally adapted, pediatric disclosure intervention on the prevalence of disclosure~     and on the medical, psychological, and social outcomes for HIV-infected Kenyan children ages~     10-15 years compared to children exposed to standard clinical care. The usual care control~     arm will have disclosure training for all clinicians, disclosure chart materials, and an~     existing protocol to implement disclosure for patients over 10 years. The disclosure~     intervention will consist of patient-centered materials to guide disclosure, including~     videotaped narratives; disclosure counselors; post-disclosure child support groups; and the~     usual care resources. The central hypothesis is that an intensive disclosure intervention~     based on culture-specific qualitative work and a patient-centered approach will allow for~     disclosure in which more children know their HIV status at younger ages, and they also have~     improved medication adherence, improved medical outcomes, unimpaired psychological outcomes,~     and no increase in experienced stigma over time.~   "
123745|NCT01947751|"~     Central venous catheter(CVC)-related infection is an inherent complication of this device~     that should be treated promptly. However, there are doubts about the need for the immediate~     withdrawal of CVC while there is still no confirmation of such infection. The aim of this~     study is to compare the resolution of CVC-related infection, testing two approaches:~     catheter´s early exchange, when the possibility of related sepsis is considered, versus the~     maintenance of the CVC and early antibiotic therapy until the infection is confirmed.~   "
123746|NCT01947738|"~     Psoriasis is an inflammatory autoimmune disease that might be controlled by a cathepsin S~     inhibitor like VBY-891.~   "
123747|NCT01947712|"~     Peripheral arterial disease (PAD) is a clinical setting characterized by an exceptionally~     high risk for cardiovascular events. Oxidative stress seems to play a role in impairing~     flow-mediated dilation (FMD) and contributing to atherosclerosis in patients with PAD. Cocoa~     seems to exert artery dilatation via oxidative stress inhibition.~      OBJECTIVES: To investigate whether in PAD patients, dark chocolate elicits artery dilatation~     via down-regulation of NOX2, the catalytic core of NADPH oxidase.~   "
123748|NCT01947699|"~     Diabetes is more likely to occur during pregnancy. When present only in pregnancy it is~     called gestational diabetes, and it places both mom and baby at risk for complications.~     Glyburide is one of the currently used treatments for diabetes during pregnancy. This drug is~     a medication taken by mouth that decreases sugar levels in the blood. It is known to decrease~     the risk of complications linked to diabetes in pregnancy. Recent studies in pregnancy have~     described a difference in the way and how well the drug works compared to when used outside~     of pregnancy.~      Oral blood sugar lowering agents are approved by the Food and Drug Administration (FDA) to~     lower blood sugar in non-pregnant subjects with diabetes. No oral (taken by mouth)~     blood-sugar lowering agents are FDA approved for use in pregnancy. Although Glyburide is not~     FDA approved for this use, it is the most commonly used oral blood sugar lowering agent in~     pregnancy.~      This research study will help us learn more about the variations in blood sugar levels in~     women with diabetes in pregnancy who are taking glyburide and how changes in the timing of~     when the glyburide is taken would affect blood glucose levels. The goals of this study are:~        -  To find the how glucose changes throughout the day in women with diabetes in pregnancy~          receiving glyburide~        -  To learn the effect of changing the time of taking glyburide on glucose levels~        -  To learn the effect of changing the time between glyburide doses on glucose levels~        -  To see if insulin is secreted the same throughout the day in response to a morning dose~          of glyburide.~   "
123749|NCT01947686|"~     The purpose of the study is to determine the survivorship rate of robotically guided isolated~     patellofemoral implants at 2, 5 and 10 year postoperative.~   "
123750|NCT01947673|"~     Patients with end-stage renal disease (ESRD) are at significantly higher risk for death due~     to cardiovascular disease. Those with paradoxical increases in blood pressure (BP) during~     hemodialysis (HD), defined as intradialytic hypertension (IDH), are at even greater risk of~     cardiovascular mortality. This study seeks to determine the mechanisms that underlie IDH, and~     whether mindfulness meditation might improve BP during dialysis in these patients. The~     investigators will first determine if increased adrenaline levels during volume removal~     contributes to IDH. The investigators will then determine lack of suppression of adrenaline~     levels in the setting of a high BP also contributes to IDH. This will be done by manipulating~     blood pressure by using small amounts of vasoactive drugs, and determining if an appropriate~     response in adrenaline levels occurs. Lastly, the investigators will determine if an~     intradialytic mindfulness meditation program improves BP and adrenaline levels in ESRD~     patients with IDH.~   "
123751|NCT01947660|"~     This study aims to assess the safety of using continuous regional anesthesia for~     post-operative analgesia during septic limb orthopedic surgery.~      The study hypothesis is that continuous regional anesthesia would not induce septic~     complication in the operated limb and could improve post-operative recovery.~   "
123752|NCT01947647|"~     Cognitive behavioral therapy (CBT) is a brief, efficient, and effective psychotherapy for~     individuals with depressive and anxiety disorders. However, CBT is largely underutilized~     within Veteran Affairs Medical Centers (VAMCs) due to the cost and burden of trainings~     necessary to deliver the large number of CBT protocols. Transdiagnostic CBT, in contrast, is~     specifically designed to address numerous distinct disorders within a single protocol. This~     transdiagnostic approach has the potential to dramatically improve the accessibility of CBT~     within VAMCs and therefore improve clinical outcomes of Veterans. The proposed research seeks~     to evaluate the efficacy of a transdiagnostic CBT by assessing clinical outcomes and quality~     of life in VAMC patients with depressive and anxiety disorders throughout the course of~     treatment and in comparison to an existing evidence-based psychotherapy, behavioral~     activation treatment.~   "
123753|NCT01947634|"~     Prospective, observational cohort study to investigate the prevalence of sleepiness and~     sleep-related breathing disorders in patients with Fabry disease (FD). For this, an Epworth~     Sleepiness Score (ESS) and ambulatory overnight respiratory polygraphy (oRP) is obtained in~     all subjects.~   "
123756|NCT01947595|"~     The purpose of this prospective randomized multicenter intervention study is to determine~     whether in the prevention of Diabetes an intensified lifestyle intervention is superior to a~     conventional lifestyle intervention in high risk non-Responder subjects. Further, the~     intensive phenotyping to determine subgroups with an increased risk for diabetes enables an~     individualized prevention and therapy of type 2 diabetes mellitus.~   "
123757|NCT01947582|"~     The purpose of this study is to investigate the impact of ankle foot orthoses (AFOs) on the~     spatial and temporal gait parameters, electromyography (EMG), walking endurance, and quality~     of life in select individuals living with MS. The hypotheses of the study are: 1. Individuals~     who are fit with an AFO will demonstrate improvements in spatial and temporal gait parameters~     2. Individuals who are fit with an AFO will demonstrate improvements in walking endurance. 3.~     Individuals who are fit with an AFO will demonstrate improvements in muscle firing~     profiles/EMG measures. 4. Individuals who are fit with an AFO will demonstrate improvements~     in quality of life.~   "
123758|NCT01947569|"~     Phase IB will evaluate the safety of autologous, ex vivo-engineered, co-stimulation impaired~     dendtritic cells to maintain and improve functional residual beta cell mass in new onset Type~     I Diabetes Mellitus (T1DM) patients. Efficacy measures will be collected and summarized.~      Phase IIA will evaluate the safety and efficacy of 3 randomized treatment groups in new onset~     T1DM patients to assess if the antisense DNA-treated co-stimulation-impaired immunoregulatory~     dendritic cells (iDC) will safely preserve and/or increase B-cell mass resulting in~     improvement and/or normalization of blood glucose levels and glycated hemoglobin A1c.~   "
123759|NCT01947556|"~     The purpose of this study is to compare the pharmacokinetic and pharmacodynamic profile of~     the rapid-acting insulin analogue aspart (Novorapid®) injected subcutaneously by~     jet-injection to that of the same insulin injected with a conventional pen in the management~     of hyperglycemia in subjects with diabetes~   "
123760|NCT01947543|"~     The aim of this study is to screen a well characterized patient population with ventricular~     tachycardia of unknown origin and treated with an implantable cardioverter-defibrillator~     (ICD) for mutations in the calmodulin genes.~   "
123761|NCT01947530|"~     The purpose of this study is to determine the safety and biopsy yield of EM Tip Tracked~     devices compared to standard bronchoscopy.~   "
123762|NCT01947517|"~     The purpose of this study is to determine if Parasol punctal occluders (Brand A) have a~     higher rate of retention than Superflex punctal plugs (Brand B).~   "
123763|NCT01947504|"~     The objective of the study is to implement and measure the efficiency of a standardized acute~     and brief non-pharmacological intervention (Cognitive interventions on Sleep - Anxiety -~     Attention - Memory) following mild TBI and observe their impact pre- and post-treatments. The~     ultimate goal is to have patients be re-integrated to their activities faster with lesser~     symptoms and have patients present lesser post-concussive symptoms. Specific objectives: 1)~     Measure the effect of an acute and brief non-pharmacological intervention on PCS symptoms,~     sleep, headaches, affect, cognition and functional outcome following mild TBI; 2)To redefine~     a model of outcome prediction following mild TBI.~   "
123764|NCT01947491|"~     The objectives of this study are to compare the safety of DFD01 Spray to Comp01 Lotion for~     topical treatment of moderate plaque psoriasis and to compare the efficacy of DFD01 Spray to~     Placebo Spray for topical treatment of moderate plaque psoriasis after 28 days of treatment.~   "
123765|NCT01947478|"~     The purpose of this trial is to assess the safety and efficacy of MDT-2113 for the~     interventional treatment of de novo and non-stented restenotic lesions in the superficial~     femoral artery (SFA) and the proximal popliteal artery (PPA) as compared to treatment with~     standard percutaneous transluminal angioplasty (PTA).~   "
123766|NCT01947465|"~     Backgound and relevance of the project:~      Patients with autoimmune inflammatory rheumatic diseases (AIIRD) are at increased risk of~     contracting infections. The increased risk can be attributed to the immunological disorder~     itself, as well as to the immunosuppressive treatment. Vaccination against many infections is~     recommended in this patient group. However, the immunogenicity of vaccines may be reduced and~     may also be influenced by the administered treatment. Potential reactivation of the~     underlying disease triggered by vaccination is another important concern.~      From the patients' and public health perspectives, an important task of physicians is giving~     advice on vaccines. Completing this task is often difficult, because data on the~     immunogenicity and safety of vaccines in these patient groups are scarce, especially with~     regard to treatment with new immunosuppressive medications, such as biological agents. Lastly~     and importantly, due to new therapeutic options, health among AIIRD patients has considerably~     improved and an increasing number of patients undertake overseas travel activities requiring~     additional vaccinations. In this context, reliable advice with regard to vaccinations is~     almost impossible, because for most travel vaccinations the immunogenicity and safety profile~     is unknown.~      Research addressing the immunogenicity and safety of vaccines in different autoimmune~     inflammatory diseases treated with different immunosuppressive medications is urgently needed~     to allow giving evidence based vaccine advice.~      In this observational study the immunogenicity and safety of tetanus booster and hepatitis A~     vaccinations will be assessed in AIIRD patients. The immune response will be evaluated as a~     function of the underlying disease and the possible influence of commonly used~     immunosuppressive drugs on the immune response will be studied.~      Rationale for studying tetanus booster and hepatitis A vaccine Tetanus vaccination is one of~     the most frequently recommended vaccinations, and the effect of a booster vaccination can be~     addressed. Hepatitis A vaccine is the most widely used travel vaccine. Despite their~     importance, only very limited data are available for tetanus and hepatitis A vaccine in this~     patient group. By focusing on these vaccines the study will lead the way to the evaluation of~     further vaccines.~      The purpose of this study is to determine whether tetanus and hepatitis A vaccinations are as~     immunogenic and safe in AIIRD patients as in healthy controls.~   "
123767|NCT01947452|"~     Chicago's Department of Family and Support Services will be providing summer employment and~     social-emotional skill training to youth over the summer of 2012. The investigators are~     partnering with them to evaluate the effects of the program. The investigators will track~     applicants to the program through existing administrative databases to assess the short- and~     long-term effects of the government's program. The investigators hypothesize that the program~     will decrease violence involvement and criminal activity, increase schooling engagement, and~     increase future employment outcomes.~   "
123768|NCT01947439|"~     The risk of restenosis in the treatment of coronary artery disease has significantly lessened~     thanks to the introduction of Drug eluting stent.~      Yet, debates on the efficacy and safety of stents in complex lesions or patients have been~     circulated.~      Recently, PCI in multiple lesions is universally performed with the development of effective~     stents in various kinds in the clinics.~      However, a randomized study is rare for multi-vessel coronary artery disease in real~     procedural environments.~      The primary purpose of this study is to evaluate the clinical progress of biolimus A9-eluting~     stent and zotarolimus-eluting stent in multi-vessel coronary artery disease.~   "
124000|NCT01944423|"~     The purpose of the current study is to evaluate the efficacy of d-cycloserine in augmenting~     treatment of smoking cessation for individuals with panic attacks. The investigators~     hypothesize that individuals receiving DCS (versus those receiving placebo) will evidence~     greater smoking abstinence rates and decreased panic symptoms after receiving a combined~     CBT-based treatment for smokers with panic attacks.~   "
123769|NCT01947426|"~     In the present study, we evaluate the effect of the mother suplementación with DHA during the~     gestation and lactation on diverse aspects of the development of newborn. The effect on the~     oxidative stress, inflammatory signaling, bone turnover and piscomotor and visual development~     was studied. Women will in the sixth month of pregnancy, consume a diet balanced during last~     3 months of pregnancy and the whole lactation. In addition the women will divide in two~     groups: one will receive a supplement of docosahexaenoic acid (DHA) to evaluate the effects~     on the development of the newborn child; whereas another group will receive a placebo.~     Different samples of blood of the mother and of mother milk will be taken and we will~     correlating her lipidic profile with the brain development of the newborn child, evaluated by~     different tests.~   "
123770|NCT01947413|"~     The fundamental goals of early rehabilitation for patients with stroke are: optimizing motor~     function within each patient's prognostic potential, preventing the development of secondary~     conditions that impact life-long health, and promoting patient's participation in their~     lives. In addition to employ clinical measures after treatment, usual outcome measures~     employed in the intervention studies included movement kinematics (spatio-temporal~     characteristics of movements). Recent reports have suggested repetitive transcranial magnetic~     stimulation (rTMS) and BoNTA (BoNTA) improved motor function in patients with stroke. A novel~     rTMS paradigm, theta burst stimulation (TBS), including intermittent TBS (iTBS) and~     continuous TBS (cTBS), that modulates human cortical excitability differently. However, there~     is lack of literatures in verifying the treatment effect by the integration of clinical and~     kinematic analysis. Until now, there are no conclusive results regarding optimal rTMS~     protocol, such as stimulating pattern and for patients with stroke. Additionally, few studies~     investigate the possible clinical characteristics of patients with stroke that may influence~     the effects of various treatment protocols proposed in this project.~   "
123771|NCT01947400|"~     Patient satisfaction is an important aspect of care and is gaining increasing importance as a~     measure of Healthcare quality. Tools for improving physician-patient communication are~     available but have not yet been tested in the Hospital setting. The purpose of this project~     is to determine if training in AIDET (Acknowledge, Introduce, Duration, Explanation, Thank)~     communication method improves physician-patient communication. Patient satisfaction data will~     be compared to historical controls using modified HCAHPS (Hospital Consumer Assessment of~     Health Plans Survey) as the primary outcome measure. In addition, a validation of delivery of~     AIDET communication will be accomplished through administration of questionnaires to~     patients.~   "
123772|NCT01947387|"~     This is a retrospective, multi-center study evaluating the outcomes of using Integra® skin~     sheet bilayer or single layer products for complex soft tissue reconstruction of lower~     extremity diabetic wounds compared to other treatments. Participating sites will collect~     information for all patients who received Integra, free flap, local tissue flap, or negative~     pressure therapy over a 5 year period. The patient must be a minimum of 1 year from index~     procedure, with index procedure being defined as the application of Integra, free flap, local~     tissue flap, or negative pressure. Any follow-up occurring during the year is eligible for~     inclusion.~   "
123773|NCT01947374|"~     This is a phase III, randomised controlled trial of matrix-encapsulated chondrocyte~     implantation procedure compared to the microfracture procedure in the repair of symptomatic~     cartilage lesions of the knee. Eligible patients were asked for informed consent~     preoperatively and randomised for chondrocyte implantation of microfractures. Those patients~     allocated to the chondrocyte implantation group will be harvested at time of first~     arthroscopic procedure and concurrent lesions were treated, as meniscus repair, ligament~     reconstruction, or malalignment corrected. The patients allocated to microfracture will be~     treated at the time of the only arthroscopic procedure. Both groups will have the same~     rehabilitation program. Prospective clinical, radiographic and magnetic resonance imaging~     will be performed as main outcomes.~   "
123774|NCT01947361|"~     Study of heterogeneity in associations between heart rate and the initial presentation of 12~     cardiovascular diseases.~   "
123775|NCT01947348|"~     To purpose of this study is to determine if treatment with SVF (Stromal Vascular Fraction)~     has an effect on pain and inflammation associated with Osteoarthritis.~   "
123776|NCT01947335|"~     This study tests the hypothesis that ultrasound-guided PCI reduces contrast volume during the~     procedure.~   "
123777|NCT01947322|"~     Leukemia cells can be killed by natural killer (NK) from HLA-I mismatched donor. The proposed~     study plans to realize an adoptive anti-leukaemic immunotherapy by infusion of HLA-I~     mismatched NK cells to treat poor prognosis acute myeloid leukemia patients. NK cells will be~     selected from HLA mismatch familial donor peripheral mononuclear cells by purification~     protocol. Before NK-infusion, patients received immunosuppressive chemotherapy.~   "
123778|NCT01947309|"~     The primary objective of this study is to document efficacy and safety data in a real-world~     setting of Chinese multiple myeloma patients who have received at least one prior therapy~     treated with REVLIMID (lenalidomide).~   "
123779|NCT01947296|"~     The purpose is to estimate evolution of patients treated by oral neoplastic agents, in term~     of early or unforeseen recourse to the hospital for adverse events.~   "
123787|NCT01947192|"~     This study aims to evaluate the effect of chlorhexidine digluconate (CRX) application in~     etched dentin on the retention of noncarious cervical lesions restorations.~      A randomized controlled split-mouth and blind trial will be carried out. Patients with at~     least two non-carious cervical lesions (NCL) will be selected. NCL will be randomly assigned~     according the type of teeth (incisors, canine or pre-molars) into two groups: control or~     experimental group (application of 2% CRX for 60 seconds after the acid etching procedure).~     Class V restorations will be performed out with an etch-and-rinse adhesive system (Adper~     Single Bond 2-3M ESPE) and a composite resin (Filtek Z350-3M ESPE) according the manufacture~     instructions, by previously trained operators. The restorations will be evaluated by a~     calibrate examiner at 1 week (baseline), and 6-month, 12-month and 24-month, using the World~     Dental Federation (FDI) criteria. The outcome is retention of the restoration.~   "
123788|NCT01947179|"~     The purpose of this study is to test the effectiveness and usability of a computer-based~     treatment for mood and anxiety relevant risk factors. The target of the treatment is related~     to cognitive stress, which has been shown to be associated with several negative mental~     health outcomes such as suicidal ideation, substance use disorders, and Post-Traumatic Stress~     Disorder.~   "
123780|NCT01947283|"~     The purpose of this study is to learn more about how patients and healthcare providers~     interact in order to improve shared decision making. The investigators plan to test an~     intervention with two separate educational components—one for patients and one for~     providers—designed to encourage patients to ask questions and increase their level of~     involvement in their own care, while simultaneously training providers to be more receptive~     to patients' questions and concerns. Patients in the intervention group will receive three~     short (30-45 minute) trainings focused on developing and asking questions and will be~     interviewed three times over the course of the intervention to see how it has affected the~     quality of their care. Providers receiving the intervention will participate in three~     separate trainings, including a 12-hour group workshop, an additional two hour training, and~     six hours of individual instruction, including personalized feedback based on three~     audio-recorded patient visits. Previous studies looking at patient engagement and involvement~     in decision-making have shown that increased engagement is linked with improved outcomes, but~     that providers are sometimes not prepared to develop a collaborative relationship with~     patients. The investigators think that training both patients and providers to work together~     and communicate more effectively will improve quality of care and increase patient~     satisfaction more than interventions that focus on only one side of the clinical encounter.~     One of the major goals in studying patient-provider communication is to improve shared~     decision-making and see how it contributes to racial and ethnic disparities in mental health~     care, since minority patients have been shown to be less involved in care and have been shown~     to be perceived and treated differently by providers.~   "
123781|NCT01947270|"~     Drug prescription is a fundamental component of care for the elderly. Even if drugs are a~     chance for the older patient, because of changes in pharmacological, pharmacokinetic and~     pharmacodynamic parameters related with age and acute/or chronic pathologies, the risks~     associated with drug prescription, particularly those associated with potentially~     inappropriate medication (PIM), are increased in the elderly.~      We suppose that many of hospitalized elderly have at least one prescribed medication without~     valid indication. Conversely, many diseases are currently undertreated in elderly patients:~     e.g. medicines used to treat heart failure and osteoporosis are underused in 20 to 70% of~     patients. Moreover, PMI prescription is associated with an increased of morbidity, mortality,~     risk of drug-related adverse events, utilization of health care system, care costs and~     impairment of quality of life. Thus, optimization of drug prescription is a major concern for~     improvement of the quality and safety of care in elderly.~      The investigators' hypothesis is that a multidisciplinary program entitled Optimisation de~     la Prescription MEDicamenteuse (Optimization of drug prescribing) focused on drug~     prescription optimization including a physician training to the specificity of the drug~     prescription in the elderly and a checklist allowing an adapted and standardized~     pharmaceutical analysis is effective in reducing PIM in elderly patients hospitalized in~     short-term medical and geriatric care departments.~   "
123782|NCT01947257|"~     The measure of the pulmonary artery pressure (PAP) is a very useful index in intensive care~     to estimate right ventricular after load. The reference technique for this measure is the~     right catheterism which is an invasive technique. It is possible to estimate the pulmonary~     artery pressure by using transthoracic echocardiography (TTE) which allows, using the~     continuous Doppler, the measure of maximum speed of tricuspid regurgitation (TRvmax). The~     measure of the TRvmax can however be difficult for intensive care patients with little~     echogenicity or impossible for those having no tricuspid leak. The evaluation of the~     tricuspid regurgitation is also particularly difficult using TOE. To avoid these drawbacks,~     one can use the analysis of the pulmonary ejection in the pulmonary artery (PAAT) with TOE.~     However, the data of the literature are controversial on this method and it was not validated~     in mechanically ventilated intensive care patients.~      The aim of this work is to compare three methods of measure of the PAP: the measure TRVMAX~     (by means of the tricuspid leak) by transthoracic echocardiography, the measure of the TAAP~     by transesophageal ultrasound and the direct measure of the pulmonary pressures by right~     catheterization, in ventilated patients already monitored with a catheter in the right~     cavities for usual indications in intensive care (ARDS, shock). We shall analyze then the~     correlation between the TRVmax, the TAAP and the pressures measured by the right catheterism~     which serves as reference technique.~   "
123783|NCT01947244|"~     The purpose of this randomized controlled trial is to examine whether evidence-based home~     visiting programs enhanced by doula services have effects on positive parenting practices,~     breastfeeding, and child and maternal health outcomes.~   "
123784|NCT01947231|"~     Effective treatment for nonspecific chronic neck pain is a clinical challenge. Patients will~     be randomized into two groups to compare the outcomes of Global Postural Re-education (GPR)~     with standard manual physical therapy on with respect to pain, function, kinesiophobia, range~     of motion, perceived effect, and satisfaction.~   "
123785|NCT01947218|"~     Asthma and COPD are characterized by an accelerated decline in lung function associated with~     incompletely reversible airflow obstruction. This could be the result of lung structural~     changes and inflammation. Tissue repairing mechanisms may result in a restitution ad integrum~     of bronchial epithelium. But in most cases, especially in COPD and severe asthma, the~     remodeling is characterized by mucus cells hyperplasia, overproduction of mucus, and~     physicochemical, biological and immunological changes. Clinically, this mucus overproduction~     is reported by patients as the clinical symptom called chronic bronchitis. Generally, it~     develops at a bronchiolar level where it is responsible for the progression of these~     diseases. There is a paradox, because the intrinsic properties of mucus seem rather~     beneficial so fighting against it may not be really wise at long-term. Especially its~     defensive effect against microbial agents which remains poorly explained. Currently, no~     treatment aims to reduce the production of mucus and mechanisms leading to such an~     overproduction are poorly understood in severe asthma and COPD. The identification of new~     targets to treat this overproduction of mucus in COPD is therefore of major interest.~      In view of current knowledge, inflammatory mediators and signal transduction leading to~     increased mucin production and increased number of goblet cells are probably IL-9, IL-13, IL~     -1ß and TNF-α involving calcium-sensitive chloride channels. Intracellular signaling pathways~     seem to be based on STAT-6, FOXA2, SPDEF, EGFR and / or COX-2~   "
123786|NCT01947205|"~     Aim of the study was to investigate the analgesic efficacy of preoperative oral dexketoprofen~     trometamol, intravenous paracetamol, lidocaine spray and paracervical block with ultracaine~     on curettage procedure.~   "
123789|NCT01947166|"~     The Whipple procedure is associated with increased readmission rates for infection,~     pancreatic leak, and failure to thrive/malnutrition. The purpose of this study is to develop~     an evidence based perioperative nutrition plan to improve patient outcomes. The study has two~     specific aims including evaluation of feasibility of implementing an evidence based~     perioperative nutritional plan for patients undergoing Whipple and evaluation of impact of a~     standard perioperative nutritional plan on primary outcome of readmission rate and secondary~     outcomes of readmission cause, length of stay for initial hospitalization and/or readmission,~     post surgical complications (surgical site infections, pancreatic leak, sepsis, delayed~     gastric emptying), and nutritional status (PG-Subject Generated Assessment scores, BMI,~     albumin, pre-albumin, and method of oral intake). Categorical variables including readmission~     rate, readmission cause, post-surgical complications and nutritional status will be compared~     by chi-square test between intervention and control group. Length of stay for initial~     hospitalization and readmission will be compared by non parametric Wilcoxon test between two~     groups. Descriptive statistics will be used to describe the sample. There are no risks to the~     study participants.~   "
123790|NCT01947153|"~     The objective of the current study is to demonstrate bioequivalence of two 2.5 mg~     linagliptin/500 mg metformin fixed dose combination tablets compared to the free combination~     of the linagliptin 5 mg and metformin 1000 mg in healthy male and female volunteers.~   "
123791|NCT01947140|"~     This is a study to test how safe the combination of the drugs Romidepsin and Pralatrexate are~     in patients with lymphoid malignancies and to determine the dose of the combination of drugs~     that is safest. If the combination is determined to be safe, the study will continue accrual~     patients with peripheral T-Cell lymphoma (PTCL).~   "
123792|NCT01947127|"~     To investigate the role of initial venous lactate in predicting the severity progression to~     overt septic shock and 30-day mortality in non-elderly patients without hemodynamic shock who~     suspected to have acute infections.~   "
123793|NCT01947114|"~     Purpose: In this study we wanted to compare bolus propofol and ketamine as an adjuvant to~     remifentanil-based total intravenous anesthesia for pediatric rigid bronchoscopy.~      Materials and Methods: Forty children under 12 years of age scheduled for rigid bronchoscopy~     were included. After midazolam premedication, remifentanil infusion 1 µg/kg/min was started~     and patients were randomly allocated to receive either propofol (Group P) or ketamine (Group~     K) and mivacurium for muscle relaxation. Anesthesia was maintained with remifentanil infusion~     1 µg/kg/min and bolus doses of propofol or ketamine. After rigid bronchoscopy remifentanil~     0.05 µg/kg/min was maintained until extubation. Hemodynamic parameters, emergence~     characteristics and adverse events were evaluated.~   "
123794|NCT01947101|"~     Patients diagnosed with ulcerative colitis (UC), a specific type of inflammatory bowel~     disease, will be invited to take part in this study. The investigators do not know what~     causes UC. However, the microbes (such as bacteria and viruses), which normally live in our~     intestines are thought to play an important role in the development of UC. There are many~     treatment options for UC such as steroids,and other medications that decrease inflammation.~     However, none of these can cure the disease.~      This study aims to treat pediatric UC in an alternative fashion by changing the microbes in~     the gut by giving the participant's stool specimens from healthy adult individuals. There is~     some evidence from a few cases of adult UC that this therapy may cure the disease or at least~     provide long lasting suppression (remission) of the symptoms. The investigators would like to~     test this therapeutic intervention in children with UC.~      The purpose of this study is to (1) examine the microbiome of stool and colon (2) and to~     determine whether healthy-donated stool enemas can treat pediatric ulcerative colitis. (3)~     The investigators will also study the effects of the treatment on colonic gene expression.~   "
123795|NCT01947088|"~     Participation in music therapy will result in improvement in cognitive functioning, as~     measured by neuropsychological testing 9-12 months following surgery.~   "
123796|NCT01947075|"~     Following the decline of malaria in Sub-Saharan Africa, clinicians face febrile patients in~     whom an alternative diagnosis has to be made. This situation has led to an overuse of~     antibiotics by clinicians. It is crucial to increase knowledge on etiologies and risk factors~     of outpatient febrile illness in order to improve their management.~      This present proposal aims to investigate the etiologies of fever among adult patients~     attending an outpatient department in urban Tanzania. It also aims to assess the clinical~     significance of nasopharyngeal (NP) respiratory viruses and bacteria documentation in this~     setting. Third, it aims to compare the spectrum of infections in this population with that of~     children included in the same setting in a previous study. The last objective is to assess~     diabetes mellitus (DM) as a risk factor for infection and exposure to indoor air pollution~     (IAP) as a risk factor for acute respiratory infections (ARI) in adults in Tanzania.~      The investigators hypothesize that acute respiratory infections are the main cause of adult~     febrile illness in a urban low-income setting and that use of quantitative molecular assays~     on naso-oropharyngeal samples can improve the diagnosis of pneumonia. The investigators also~     think that the spectrum of infections is different between children and adults, mainly due to~     a high HIV prevalence in adults. The investigators also hypothesize that experiencing IAP~     and/ or DM is a risk factor for infections in adults.~   "
123797|NCT01947062|"~     Treatment of locally advanced and metastatic squamous cell carcinoma of the lung involves the~     use of chemotherapy as the therapeutic mainstay. Platinum-etoposide regimens (such as~     cisplatin-etoposide) are the most commonly used chemotherapeutic regimen, which is delivered~     intravenously in the standard three-weekly intervals.~      Recent interest in oral metronomic chemotherapy has arisen, especially due to its beneficial~     effects in delaying disease progression among heavily pre-treated patients with various~     malignancies.~      This study attempts to combine the use of metronomic chemotherapy concurrently during~     standard intravenous chemotherapy.~   "
123798|NCT01947049|"~     The purpose of this study is to:~        1. Evaluate the clinical performance of a newly available highly-sensitive rapid influenza~          test, Xpert Flu.~        2. Derive and validate an adult clinical decision guideline to guide clinical testing of~          influenza patients who meed CDC criteria for antiviral treatment.~        3. Evaluate impact of rapid influenza testing for antiviral treatment.~        4. Determine cost effectiveness of influenza testing and treatment strategies.~   "
123799|NCT01947036|"~     The study aims to establish whether defects in immune cell function are shared across~     multiple autoimmune diseases and whether those problems match to similar genes in the cells.~   "
123801|NCT01947010|"~     Inflammatory bowel disease (IBD) are at increased risk of infections. This increased~     susceptibility to infections is due to the disease itself, but also be-cause many patients~     with autoimmune conditions are treated with immuno-suppressive drugs, such as azathioprine~     and or TNF-a inhibitors.~      Streptococcus pneumoniae (pneumococcus) is a cause of worldwide morbidity and mortality and~     one of the most common cause of bacterial meningitis in adults. Infection with pneumococcus~     can be prevented with vaccination. Two pneumococcal vaccine are used in Denmark, the 23~     valent polysaccharide-based vaccine (23PPV) and the 13 valent of conjugate pneumococcal~     vaccines (PCV13).~      In this study the investigators wish to study the effect of pneumococcal vaccination with~     either PPV23 or PCV13 in IBD patients treated with either TNF-a inhibitors, azathioprine or~     untreated.~   "
123802|NCT01946997|"~     The purpose of this study is to evaluate topographic features of the posterior pole of the~     eye in normal subjects as well as in subjects with diabetes mellitus but without diabetic~     retinopathy (DR) using optical coherence tomography (OCT). The investigators proposal is a~     novel study to determine retinal volume of normal and diabetic subjects without DR.~     Specifically, the investigators will establish a standardized reference range for retinal~     thickness and volume that will provide standards for OCT analysis of different clinical~     trials for retinal diseases.~   "
123803|NCT01946984|"~     1. The most common complication of endoscopic retrograde cholangio-pancreaticography (ERCP)~          is pancreatitis.~        2. Several studies showed that non-steroidal anti-inflammatory drugs (NSAIDs) can prevent~          the post ERCP pancreatitis, the investigators used diclofenac vs placebo.~        3. The effect of diclofenac in prevention of that complication, was measured by the number~          of patients who developed pancreatitis, and compare it with the placebo.~        4. The investigators collected 199 patients, 17 excluded, 182 completed the study, all of~          them underwent the intervention called ERCP, and randomized to have either Diclofenac~          or Placebo before the procedure.~   "
123804|NCT01946971|"~     This study is crossover study to evaluate safety and efficacy of lansoprazole in preterm~     infants with gastroesophageal reflux.~   "
123805|NCT01946958|"~     The objective of this study is to conduct a randomized control trial to evaluate the impact~     of Triple P on the clinic practice of pediatric residents and on select parent and child~     outcomes. This study will accomplish that overarching goal through addressing two specific~     aims.~      Aim 1. Triple P's Effect on Pediatric Resident's Practice: test the effect of Triple P~     training on practice of pediatric residents in addressing and managing psychosocial problems.~      Hypothesis 1: At the completion of the trial, residents assigned to the intervention group,~     compared to residents exposed to the control condition, will have:~        1. increased skill levels,~        2. increased confidence, and~        3. increased satisfaction in dealing with and managing psychosocial issues~      Aim 2. Triple P's Effect on Parent and Child Outcomes: test the effect of Triple P~     interventions on parent's feelings of self efficacy, parent's discipline strategies and on~     children's externalizing behavior.~      Hypothesis 2: At the completion of the intervention, parents and children receiving the~     intervention, compared to those receiving the control condition, will have:~        1. greater reduction in targeted child behavior problems,~        2. greater reduction in dysfunctional parenting practices,~        3. increased use of appropriate discipline and positive parenting strategies, and~        4. greater confidence in parenting ability.~   "
123806|NCT01946945|"~     We propose to perform a clinical randomized trial to evaluate the effect of blastocyst biopsy~     and whole chromosome analysis by Next Generation Sequencing (NGS) in comparison to standard~     Assisted Reproductive Technologies (ART) methods on on implantation rates, miscarriage rates,~     and pregnancy rates.~      This will be three studies into one: a) a comparison of treatment (NGS) and no treatment, b)~     a non-selection study based on the control group for which we will replace without knowing~     the ploidy of the embryos, but we will know it later, c) a retrospective study about the use~     of Mitochondrial DNA as a selection tool.~   "
123807|NCT01946932|"~     This is a steering group approved substudy to the Target Temperature Management trial (TTM,~     ClinicalTrials.gov Identifier: NCT01020916). TTM compares the effect of two strictly~     controlled temperature regimes for survivors of out-of-hospital cardiac arrest.~      The primary aim of this sub-study is to compare the amount of cognitive impairment in cardiac~     arrest survivors treated with 33 degrees and 36 degrees and with a matched group of control~     patients with myocardial infarction.~      Our secondary aims are:~        -  To investigate the impact of cognitive impairment on our patients' ability to~          participate in society and their health related quality of life.~        -  To investigate the relationship between our patients cognitive impairments and their~          relatives/informants health related quality of life and feelings of burden.~        -  To test the hypothesis that the simple cognitive screening battery used in the TTM main~          trial is sensitive enough to detect all patients with significant cognitive disability.~   "
123808|NCT01946919|"~     Cinepazide Maleate Injection is widely used in cerebrovascular disease in china. The safety~     of the cinepazide, especially the blood system, has not been fully evaluated in Chinese~     population. In order to improve the rational use of cinepazide, the investigators observe its~     clinical use in the real world in China, evaluate its safety and clinical benefit in a large~     Chinese population.~   "
123819|NCT01946776|"~     Patients with difficult-to-treat epilepsy (refractory epilepsy) are at high risk of sudden~     death: sudden unexpected death in epilepsy (SUDEP). Cardiac arrhythmias are one of the~     possible causes of SUDEP. When monitoring in the hospital setting, the frequency of cardiac~     arrhythmias in people with epilepsy is low: 0,4%. However, when a subcutaneous implantable~     device (Reveal XT) is used to monitor heart rhythm continuously for an extended period of~     time, the frequency of clinically relevant arrhythmias appeared much higher in two small~     observational studies (n=19): 6-20%. The aim of this study is to analyze the frequency and~     underlying mechanism of cardiac arrhythmias in a larger group of 50 people with refractory~     epilepsy with Reveal XT. In the future, this may help us to identify those epilepsy patients~     at high risk of cardiac arrhythmias, so that we can timely institute preventive measures~     (e.g. pacemaker implantation).~   "
123820|NCT01946763|"~     The recovery and emergences from anesthesia is a critical phase. Previous studies focused on~     pharmological and anesthetics techniques to improve the quality of this stage (duration,~     complications).~      In this study, our first aim is to test the impact of pre operative education on the post~     operative recovery for morbidly obese patient underwent laparoscopic bariatric surgery.~   "
123809|NCT01946906|"~     Patients with Common variable immunodeficiency (CVID) have various forms of autoimmune and~     auto inflammatory disorders. The study will investigate if intervention with Rifaximin~     modifies the gut microbiota with a subsequent alteration in markers of systemic immune~     activation and inflammation in patients with CVID. The investigators hypothesize that the gut~     microbiota of CVID patients, at least partly through interaction with the innate immune~     system within the intestine, contribute to a low-grade systemic inflammation in these~     patients, and that an intervention with the non-absorbable antibiotic Rifaximin attenuates~     systemic inflammation through modulation of the gut microbiota. The study may lead to~     increased understanding of the interaction between microbiota and the immune system. The~     study could give new insight into important disease processes in relation to the interaction~     between the microbiota, the intestine and the systemic compartment, and potentially be the~     basis of new therapeutic strategies in these patients to prevent and down-regulate the~     auto-inflammatory and autoimmune complications seen in CVID. The findings could also be of~     relevance for other disorders where the interaction between microbiota and intestinal and~     systemic inflammation is involved such as various cardiovascular and metabolic disorders.~      The investigators hypothesize that the gut microbiota of CVID patients, at least partly~     through interaction with the innate immune system within the intestine, contribute to a~     low-grade systemic inflammation in these patients, and that an intervention with the~     non-absorbable antibiotic Rifaximin attenuates systemic inflammation through modulation of~     the gut microbiota.~   "
123810|NCT01946893|"~     The purpose of this pilot study is to collect feasibility and acceptability of an internet~     mindfulness meditation intervention for older adults and to collect preliminary data on mood~     and cognition changes from before to after the intervention. Up to 32 older adults will be~     randomized to receive a mindfulness meditation intervention or a time and attention control,~     both delivered over the internet (16 completers). Participants will have a one-hour session~     weekly for six weeks with daily home practice between sessions. Participants will complete~     the sessions online with a study iPad. Their home practice will also be installed on the~     study iPad as well as an objective adherence monitoring program that the investigators~     developed to track actual home practice between sessions. The feasibility and acceptability~     measures are enrollment rate, completion rate, and participant satisfaction. Self-report mood~     questionnaires and cognitive tasks will be measured before and after the intervention period~     and data used to conduct power analyses and sample size estimation for a larger clinical~     trial.~   "
123811|NCT01946880|"~     This trial seeks to describe the effect of withdrawal from mycophenolate mofetil (MMF) on~     risk of clinically significant disease reactivation in quiescent SLE patients who have been~     on long-term MMF therapy.~   "
123812|NCT01946867|"~     RATIONALE: Cancers of the oral cavity represent 30% of head and neck carcinomas in the~     western world. The oropharynx is the posterior continuation of the oral cavity and connects~     with the nasopharynx (above) and laryngopharynx (below). It is also a frequent site of~     primary head and neck cancers. These structures play a crucial role in swallowing, breath and~     speech. Locally advanced oropharyngeal cancers can obstruct the air flow or infiltrate~     muscles or nerves, which significantly disturb local functions. The incidence of Head and~     Neck Squamous Cell Cancer in patients older 65 years is high, 47% occurred in this population~     as recorded by the Surveillance, Epidemiology, and End Results registries in the United~     States. Regarding the therapeutic strategies, the association of radiotherapy with~     chemotherapy or biologics has demonstrated significant improvement of outcomes with the~     drawback of higher toxicity, or as demonstrated by 2 meta-analyses, without survival~     improvement in older patients. NBTXR3 and radiation therapy may increase the cancer cell~     killing and complete tumor shrinkage allowing a definitive treatment and preservation of~     local structures and functions in patients older 65 years, who cannot receive cisplatin.~   "
123813|NCT01946854|"~     Appendiceal cancer is a rare disease that does not cause many symptoms. As such, doctors are~     not sure if chemotherapy actually has an effect on the disease. The goal of this clinical~     research study is to learn more about the effects that chemotherapy may have on appendiceal~     cancer.~   "
123814|NCT01946841|"~     The objective of this unblinded study is to assess the nutritional effects of a 12 weeks~     administration of the specific enteral nutrition (SEN) RealDiet®Renal pockets, as well as the~     impact on the patients' quality of life.~   "
123815|NCT01946828|"~     The objective of this clinical trial is to evaluate the FIM optimal configuration and confirm~     the safety and performance/efficacy of the FIM when exposed to a larger and more varied~     population of users.~   "
123816|NCT01946815|"~     Natural course of intermediate coronary artery disease (CAD) is very important to predict the~     prognosis of the patient with such disease.~      Several studies have well demonstrated the beneficial effect of lipid-lowering therapy on the~     progression of CAD with the modification of lipid profiles.~      This effect can be also explained by intravascular ultrasound (IVUS) or optical coherence~     tomography. However, the effect of plaque modification on coronary physiology has been rarely~     evaluated.~      This research is to evaluate the change of intermediate or nonculprit coronary lesion on~     lipid-lowering therapy via IVUS(optional) and FFR.~   "
123817|NCT01946802|"~     Current guidelines recommend the use of sedatives and neuromuscular blocking agents to avoid~     shivering during therapeutic hypothermia in cardiac arrest victims. Therefore, it is~     difficult to detect seizure and the frequent or continuous EEG monitoring is recommended.~     However, it is difficult to follow this recommendation in most clinical situations due to the~     lack of specialized devices and persons. The purpose of this study is whether SEDline~     (frontal 4-channel EEG device) has a diagnostic value to detect seizure during therapeutic~     hypothermia in cardiac arrest victims.~   "
123818|NCT01946789|"~     The proposed clinical trial is a phase I, open-label, multi-center, dose-escalation study of~     ALT-803 in patients with surgically incurable advanced solid tumors: melanoma, renal cell,~     non-small cell lung and squamous cell head and neck cancer~   "
123929|NCT01945346|"~     This is an exploratory study to evaluate a new anti-inflammatory drug, PRX167700, in subjects~     with painful osteoarthritis of the knee.~      The purpose of this study is to investigate if PRX167700 improves the pain from~     osteoarthritis of the knee, and to assess its safety and tolerability. The study will also~     investigate PRX167700 pharmacokinetics.~   "
123821|NCT01946750|"~     Hypothesis: the antibody directed against certain antigens of Clostridium difficile would be~     predict the Clostridium difficile infection.~      This study evaluates the weight of immunity by studying patients with Clostridium difficile~     infection versus controls (each patient is associated with two controls : diarrheal control~     without Clostridium difficile, and non-diarrheal control with or without Clostridium~     difficile). Recurrence and the kinetics of immune response following infection Clostridium~     difficile are studied by following the patients during three months.~      There are also building biological samples collections clinically documented: sera, stool and~     strains.~   "
123822|NCT01946737|"~     CT technology is evolving at a rapid pace, with introduction of multidetector row CT scanners~     (MDCT) and electrocardiographic (ECG) gating resulting in increasing numbers of heart scans~     CTCA (CT Coronary Angiography). CTCA provides a noninvasive alternative to conventional~     invasive coronary angiography (ICA), which is considered the gold standard in the~     investigation of coronary disease. There has been a gradual increase in the utilization of~     CTCA for primary assessment of low and intermediate risk patients. However concerns regarding~     radiation exposure and diagnostic accuracy, especially in the highrisk group, have prevented~     its widespread dissemination.~      To achieve best possible temporal resolution (minimize cardiac motion artifacts) and spatial~     resolution (provide diagnostic accuracy) relatively high radiation exposure is required, as a~     result of its inverse relationship with image noise and resolution. However radiation (X-ray)~     is associated with increased risk of cancer in exposed patients and it is therefore essential~     to continually devise strategies to reduce radiation exposure whilst maintaining image~     quality.~      A state-of-art CT scanner (Discovery CT750 HD, General Electric (GE) Healthcare), has been~     installed at Derriford hospital for further research on CTCA. It uses novel method of~     scanning, High Definition Computed Tomographic Coronary Angiography(HD-CTCA), analogous to~     high definition television) and image reconstruction (Adaptive Statistical Iterative~     Reconstruction ASIR)as opposed to conventional CT scanners using Filtered Back Projection~     (FBP)reconstruction. HD-CTCA enables acquisition of sharper images and ASIR offsets the~     resultant increase in radiation exposure. This is likely to result in images of higher~     diagnostic quality with an equivalent or slightly lower radiation exposure compared to~     present technology. Although initial results are encouraging, this needs further assessment~     before being applied to routine clinical practice. To assess this we have designed a study to~     perform HD-CTCA on 300 consecutive patients undergoing diagnostic ICA at Derriford hospital,~     directly comparing the accuracy of HD-CTCA to ICA (presently considered the gold standard).~      Hypotheses:~      There is no significant difference in the sensitivity and specificity of HD-CTCA for the~     detection of coronary artery stenosis of 50% or greater compared to conventional ICA.~   "
123823|NCT01946724|"~     The purpose of this study is to study whether percutaneous chronic total occlusion (CTO)~     revascularization, by the use of Percutaneous Coronary Intervention (PCI), stenting,~     guidewire, and catheter, improves a patient's quality of life and their left ventricular~     function, reduces angina severity, and improves long-term survival.~   "
123824|NCT01946711|"~     The study should create data for the selection of a clinically relevant primary endpoint to~     assess the efficacy and safety of Buparid/PARI SINUS as compared to Budes Nasal Spray in the~     therapy of chronic rhinosinusitis (CRS) with polyposis nasi in adult patients. Ideally, the~     selected parameter should allow a correlation between an objective methodology and the~     clinical outcome of the study patients.~   "
123825|NCT01946698|"~     To investigate parameters related to fertility in women with endometriosis in relation to~     food items.~   "
123826|NCT01946685|"~     Posttraumatic stress disorder (PTSD) is a common and disabling psychiatric disorder. Left~     untreated or under-treated, it can become a chronic condition associated with significant~     distress, depression, aggression, family disruption, and substance abuse. There is also~     accumulating evidence that combat-related PTSD is associated with an increased risk of~     morbidity and mortality. For the welfare of returning veterans with PTSD and their families,~     it is critical that this disorder is promptly identified and effectively treated.~     Considerable advances that have been made in the assessment and treatment of PTSD in recent~     years; however, psychopharmacological treatments have been shown to be largely ineffective~     for veterans with PTSD.~      To address this gap, this proposal seeks to test an innovative treatment approach in PTSD -~     pharmacological manipulation of the body's major stress system (the~     hypothalamic-pituitary-adrenal (HPA) axis) with mifepristone. At high doses mifepristone is a~     glucocorticoid receptor (GR) antagonist with peripheral and central nervous system effects,~     making it a compound of interest in the treatment of stress related disorders. There is~     abundant evidence of enhanced GR sensitivity in veterans with PTSD which is thought to~     underlie some of the symptoms of PTSD and associated disturbances in mood and cognition.~     Thus, blockade of the GR receptor with mifepristone may target unique aspects of PTSD and~     lead to clinically meaningful improvement in symptoms and cognition. There is preliminary~     evidence that short-term mifepristone treatment has sustained beneficial effects on mood,~     cognition and sleep disturbance in some neuropsychiatric conditions (major depression,~     bipolar disorder, primary insomnia). That there can be sustained clinical and~     neuropsychological effects of mifepristone and normalization of basal HPA axis activity after~     drug discontinuation in these disorders, has led to the view that mifepristone's actions~     include recalibration of a dysregulated HPA axis. Accordingly, we propose to study the~     effects of mifepristone in veterans with chronic PTSD to determine if it is efficacious in~     improving PTSD symptoms and associated clinical outcomes. To better understand the mechanism~     of action of mifepristone we propose to assess the effects of mifepristone on HPA axis~     activity and their relationship to treatment outcome and clinical response.~      To achieve these objectives, we propose to conduct a Phase IIa, multi-site, double-blind,~     placebo controlled trial of mifepristone in veteran outpatients with military-related PTSD~     through the VA's Cooperative Clinical Trial Award program. We propose to enroll 136~     unmedicated male veterans with military related PTSD at four VA sites (Albuquerque, NM,~     Bronx, NY, Durham, NC, and San Diego, CA). Eligible veterans will be randomly assigned in~     parallel groups to treatment with 600 mg/day mifepristone or placebo for one week and~     followed for up to three months. Using statistical selection theory, we propose to determine~     whether 600 mg of mifepristone yields a sufficiently high proportion of clinical responders~     after one month to warrant more extensive and definitive research as part of a Phase III~     trial. Secondarily, we seek to determine the effect of the dose of mifepristone compared to~     placebo on the trajectory of CAPS scores and the time to addition of rescue medication, as~     well as compare rates of adverse events and serious adverse events across the three groups.~     We will also describe the effects of mifepristone on several other clinical parameters~     including PTSD symptomology, depression severity, sleep quality, and functional impairment.~     Several measures of neuroendocrine functioning will also be obtained to explore the~     relationship of plasma cortisol and ACTH levels to clinical response and the time to addition~     of rescue medications.~   "
123827|NCT01946672|"~     The purpose of this study is to evaluate the feasibility of an isotopic technique to~     identify, and to map the lower-limb drainage nodes during pelvic lymphadenectomy for~     gynaecological cancers. The diagnostic value of our mapping method will be assessed, and we~     will determine the incidence of lymhedema.~   "
123828|NCT01946659|"~     This is a randomized controlled Trial to evaluate effect of a culturally and linguistically~     tailored, telephone-delivered behavioral intervention on adherence to recommended assessment~     and treatment of sleep apnea in Blacks with Metabolic Syndrome. The investigators believe low~     awareness of Sleep Apnea and the risk it imposes to an individual health plays an important~     role in underdiagnosis and low adherence to treatment among Blacks. Hence, culturally and~     linguistically tailored health education will decrease the knowledge gap and improve~     adherence to recommended assessment and treatment of sleep Apnea. the investigators believe~     the effect of adherence to treatment of Sleep apnea is shown to improve the components of~     Metabolic syndrome and hence promote well control of Hypertension, Diabetes, weight,~     triglyceride and cholesterol.~   "
123829|NCT01946646|"~     The purpose of this study is to determine whether combination of TS-1 and concurrent and~     short-course radiotherapy is feasible in metastatic pancreatic cancer. The rationale of this~     study primarily bases on the good efficacy of gemcitabine plus TS-1 and the great potential~     of local control of concurrent chemoradiotherapy in pancreatic cancer.~   "
123830|NCT01946633|"~     The present study is a feasibility study to assess the safety and efficacy of wireless~     capsule endoscope and compare the data obtained with those obtained by using a conventional~     esophagogastroduodenoscopy.~      The product was developed and manufacture in China.(the NaviCam. AKC-1.China)~   "
123831|NCT01946620|"~     Efficacy of Fluticasone/Formoterol in COPD Treatment. The Effect study.~   "
123832|NCT01946607|"~     Neuroticism is a personality trait described as an enduring tendency to experience negative~     emotional states and to respond poorly to environmental stress. It has been shown that high~     neuroticism can predispose, amongst other factors, to the development of depressive episodes.~     Recent studies suggest that subjects with high neuroticism have a different response to~     stimuli with an emotional content, showing both decreased processing of positive or increased~     processing of negative emotionally salient cues. These differences in cognitive processing of~     emotional stimuli are believed to underpin the psychological characteristics that link high~     neuroticism with a higher risk for depression.~      Preliminary data also indicate that modulation of serotonin function by antidepressant~     treatment in healthy volunteers with high neuroticism traits could modify the brain activity~     associated with the processing of emotional stimuli that is dysfunctional in this vulnerable~     population.~      The aim of this research is to investigate further whether modulation of serotonin function~     via administration of serotonergic antidepressants (SSRIs) can revert the dysfunctional~     emotion processing that characterises subjects with the personality trait of high~     neuroticism.~      In particular we hypothesise that SSRI administration will modify the abnormal patterns in~     attention, physiological reactivity and regulation of emotional stimuli present in healthy~     individuals with the vulnerable personality trait of high neuroticism.~      Carrying out this research on healthy volunteers will enable us to understand if modulating~     serotonin function by antidepressant administration has an effect not only on mood symptoms -~     as is evident in depressed patients - but also on the predisposing psychological and~     cognitive processes that sustain the depressed mood, such as the response to emotional~     stimuli. We will also be able to verify if this effect is shown early treatment and prior to~     any subjective changes in mood. This will be done by administering seven days of either the~     antidepressant citalopram or placebo to subjects with high neuroticism scores and then~     comparing them on a series of computer based psychological tests measuring various aspects of~     how emotionally salient stimuli are processed.~   "
123930|NCT01945333|"~     The purpose of this study is to develop and pilot test personalized and scalable approaches~     to Cognitive Remediation (CR) for schizophrenia and schizoaffective disorder. The intent is~     to more clearly define the therapeutic targets important to the facilitation of cognitive and~     functional improvement so that clinicians know how to customize cognitive interventions and~     deliver treatment in a more effective, efficient and personally relevant manner.~   "
123833|NCT01946594|"~     The study team aims to conduct a double-blind, placebo-controlled, pilot study to assess the~     effect of prophylactic antipyretics on the immune responses and rates of fever after~     inactivated influenza vaccine (IIV) in children 12 through 35 months of age. In this pilot,~     40 healthy children, 12 through 35 months of age, including some children at risk of febrile~     seizure, will be randomized to receive prophylactic acetaminophen or oral placebo immediately~     following and every 4 to 6 hours in the 24 hours after receipt of a dose of IIV. Data derived~     from the pilot study will be used to assess the feasibility of conducting a larger scale~     study. Feasibility will include assessments of the speed and ease of study recruitment and~     adherence to and completion of study assessments. Children will be followed for the~     occurrence of fever, fussiness, changes in appetite and sleep patterns, and use of medical~     services on the day of and day following vaccination. Antibody to influenza antigens~     contained in the 2013-2014 vaccine as measured by hemagglutination inhibition (HAI) antibody~     will be assessed at baseline and four weeks following vaccination. The proportions of~     children experiencing fever, having solicited reactions, using medical services,~     demonstrating a serologic response corresponding to seroprotection and seroconversion to each~     of the IIV antigens will be determined for groups of children receiving acetaminophen and~     placebo. Likewise geometric mean HAI titers (GMT) and corresponding 95% confidence intervals~     for each IIV antigen will be calculated for both vaccine groups.~   "
123834|NCT01946581|"~     Define what factors correlate with higher degrees of patient satisfaction and dissatisfaction~     among patients who have recently undergone cataract surgery.~   "
123835|NCT01946568|"~     A phase one study to characterize the pharmacokinetics of dalbavancin in pediatric patients~     aged 3 months to 11 years (inclusive) following the intravenous administration of a single~     dose of dalbavancin.~   "
123836|NCT01946555|"~     The BTP (Breakthrough pain)was defined as a transient exacerbation of pain that occurs~     either spontaneously, or in relation to a specific predictable or unpredictable trigger,~     despite relatively stable and adequately controlled background pain.~      The BTP is a common clinical features in patients with cancer pain (BTcP: breakthrough cancer~     pain). The prevalence of BTcP is equal to 56%.~      Currently, the investigators tend to recognize the idiopathic/spontaneous or accident BTcP in~     the three sub-types: voluntary, non- voluntary and procedural.~      The diagnosis of BTCP is not always easy because in the cancer patient is normal to observe~     changes in the intensity of pain during the day, so it is necessary to differentiate slight~     fluctuations from the presence of real episodes of BTCP, for which is necessary to use a~     rescue treatment adjusted. In the study will be proposed the use of a diagnostic algorithm,~     present in the literature, to perform the diagnosis of BTCP.~      In the presence of BTCP, is important both a correct controlled background pain with major~     opioids, which can reduce the number and the intensity of the painful episodes, both~     implement an adjunctive therapy, called rescue, to be administered at the time which takes~     over the painful episode using, in this case, an opioid greater.~   "
123837|NCT01946542|"~     The purpose of this project will be to determine whether consumption of beet juice~     concentrate prior to exercise may acutely improve exercise tolerance in patients with heart~     failure.~   "
123838|NCT01946529|"~     This protocol will study treatment for Ewing sarcoma family of tumors (ESFT) and desmoplastic~     small round cell tumor (DSRCT). Participants with ESFT will be divided into two treatment~     groups, A or B, based on tumor characteristics.~      Group A (standard risk) participants have tumor that is not in the pelvis, has not spread to~     other parts of the body, and are less than 14 years of age. Because previous clinical trials~     have shown that standard treatment is very effective for children whose tumors have these~     characteristics, these participants will receive standard treatment.~      Group B (high risk) participants are 14 years of age or older or have tumor in the pelvis, or~     the tumor has spread to other parts of the body. Participants with DSRCT in the abdomen~     and/or pelvis or with tumor that cannot be removed by surgery alone or has spread to other~     parts of the body will be included in Group B. Participants in this group are considered high~     risk because there is a greater chance of tumor recurring following standard treatments~     currently in use.~      All participants will be followed and evaluated for 10 years following completion of therapy.~   "
123839|NCT01946516|"~     The goal of this study is to estimate the prevalence of HIV, Hepatitis B and hepatitis C~     infection among newly diagnosed cancer patients presenting to community and academic oncology~     clinics.~   "
123840|NCT01946503|"~     The purpose of this study is to better understand why children with short gut develop feeding~     problems.~   "
123841|NCT01946490|"~     A large group of non-small cell lung cancer patients is treated with radiotherapy. Delivery~     of very high radiation doses is needed to obtain local control, but due to the large tumor~     and nodal volume this is often impossible without causing unrepairable damage to the normal~     tissue of the mediastinum, spinal cord, esophagus and lung.~      Although every tumor is different with respect to the speed with which it grows and spreads,~     it is obvious that time plays an important role in cancer therapy. Recently it was reported~     that disease progression or increase of tumor volume occurred during the time interval~     between diagnosis and treatment.(1, 2) This could lead to a less optimal radiation treatment~     and consequently have an impact on overall survival. Moreover, the increasing number of~     diagnostic procedures, aimed at obtaining more accurate information about the tumor extension~     and biology, as well as the use of more sophisticated but labor intense radiation techniques~     could prolong the time interval between clinical symptoms and the start of the treatment.~     However, the influence of new diagnostic procedures or the applied radiotherapy techniques on~     waiting times is not yet known. The investigators therefore want to investigate 1) time~     trends in the waiting time for NSCLC patients, 2) the correlation between waiting times and~     the use of more advanced diagnostic or therapeutic procedures, and 3) the correlation between~     waiting times and overall survival.~      The hypotheses of the study:~        1. The diagnostic delay for NSCLC patients has increased during the last 12 years.~        2. The preparation time for radiotherapy of NSCLC patients has increased during the last 12~          years.~        3. Prolonged waiting times are associated with worse overall survival outcome.~   "
123931|NCT01945320|"~     A prospective long-term follow up of hemodialysis (HD) patients' outcome correlates with~     nutritional status and body composition. We will evaluate the body composition change among~     HD patients every three months with bioelectrical impedance analysis (BIA). The change of~     body composition will correlated with other clinical data including nutritional, inflammatory~     parameters and survival.~   "
123842|NCT01946477|"~     This trial will evaluate the efficacy and safety of combination of pomalidomide (POM) and~     low-dose dexamethasone (LD-Dex) (Cohort A) or the combination of pomalidomide (POM) ,~     daratumumab (DARA) and low-dose dexamethasone (LD-Dex) (Cohort B) in subjects with relapsed~     or refractory multiple myeloma who have received a first or second line treatment of~     lenalidomide-based therapy.~      This trial will test the hypothesis for Cohort A that the proportion of patients will have an~     Overall Response Rate (ORR) of > 30 % to reveal that Pomalidomide is efficacious in~     pretreated patients who are refractory to lenalidomide.~      This trial will test the hypothesis for Cohort B that the proportion of patients will have an~     Overall Response Rate (ORR) of > 70 % to reveal that POM+DARA+LD-Dex is efficacious in~     pretreated patients who are refractory to lenalidomide.~   "
123843|NCT01946464|"~     This study is being done to see if we can improve the way we manage patients' airways. In~     some instances patients who have a beard, who do not have teeth or have breathing problems~     during sleep present a challenge to the anesthesiologist. In such patients, it is sometimes~     difficult to provide air/oxygen for breathing using a mask. The study doctors would like to~     investigate a new method for holding a mask on the face of those patients. They are~     interested in comparing a new method against two older methods. They believe the new method~     will deliver a larger amount of air to the lungs. This information may help doctors provide~     better care for patients who have beards, no teeth, or breathing problems during sleep.~   "
123844|NCT01946451|"~     The purpose of this study was to investigate the expression of selected genes both in~     epiretinal membranes (ERMs) and peripheral blood mononuclear cells (PBMCs) from patients with~     primary and secondary epiretinal membranes in proliferative diabetic retinopathy. Possible~     correlations between messenger ribonucleic acid (mRNA) levels of these genes were also~     identified.~   "
123845|NCT01946438|"~     The aim of the study is describe the safety and immunogenicity of Fluzone Quadrivalent and~     Fluzone Intradermal vaccines in adults 18 to < 65 years of age, and to describe the safety~     and immunogenicity of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65~     years of age.~      Primary Objective:~        -  To describe the safety of the 2013-2014 formulations of Fluzone Quadrivalent and Fluzone~          Intradermal vaccines in adults 18 to < 65 years of age and the safety of the 2013-2014~          formulations of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65 years~          of age.~      Observational objectives:~        -  To describe the immunogenicity of the 2013-2014 formulations of Fluzone Quadrivalent and~          Fluzone Intradermal vaccines in adults 18 to < 65 years of age and the immunogenicity of~          the 2013-2014 formulations of Fluzone Quadrivalent and Fluzone High-Dose vaccines in~          adults ≥ 65 years of age.~        -  To evaluate the compliance, in terms of immunogenicity, of each study vaccine (Fluzone~          Quadrivalent, Fluzone Intradermal, and Fluzone High-Dose) in the applicable age group~          with the historical requirements of the Committee for Human Medicinal Products (CHMP)~          Note for Guidance (NfG) CPMP/BWP/214/96.~        -  To submit sera from selected subjects to the Center for Biologics Evaluation and~          Research (CBER) for further analysis by the World Health Organization (WHO), the Centers~          for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) to~          support formulation recommendations for subsequent influenza vaccines.~   "
123846|NCT01946425|"~     The aim of this study is to evaluate the safety and immunogenicity of Fluzone® Quadrivalent~     vaccine in participants aged 6 months to < 9 years at enrollment, divided into 2 age strata~     (6 months to < 36 months and 3 years to < 9 years)~      Primary Objective:~        -  To describe the safety of the 2013-2014 formulation of Fluzone Quadrivalent vaccine,~          administered in a 1- or 2-dose schedule, in accordance with Advisory Committee on~          Immunization Practices (ACIP) recommendations, in children 6 months to < 9 years of age.~      Observational Objectives:~        -  To describe the immunogenicity of the 2013-2014 formulation of Fluzone Quadrivalent~          vaccine, administered in a 1- or 2-dose schedule in accordance with ACIP~          recommendations, in children 6 months to < 9 years of age.~        -  To submit sera from subjects to the Center for Biologics Evaluation and Research (CBER)~          for further analysis by the World Health Organization (WHO), the Centers for Disease~          Control and Prevention (CDC), and the Food and Drug Administration (FDA) to support~          formulation recommendations for subsequent influenza vaccines.~   "
123847|NCT01946412|"~     The purpose of this study is to provide information regarding the long-term safety and~     pharmacodynamics of ivacaftor treatment in the pediatric population younger than 6 years of~     age with Cystic Fibrosis (CF) who have a CFTR gating mutation in at least 1 allele and will~     further explore the efficacy of long-term ivacaftor treatment in this population of patients~     with CF.~   "
123848|NCT01946399|"~     To determine if Ozurdex implant can offer an effective treatment for macular edema associated~     with retinal vein occlusion when treatment with intravitreal Avastin, Lucentis, or Eylea have~     not demonstrated a significant response.~   "
123849|NCT01946386|"~     The purpose of this study is to compare the pharmacodynamic activity of LEO 90100 with~     Dermovate® cream, Dovobet® ointment, betamethasone dipropionate in LEO90100 vehicle, Synalar®~     ointment and LEO 90100 vehicle using a human skin blanching test.~   "
123850|NCT01946373|"~     The purpose of this study is to learn if dendritic cell vaccine will increase the effect of~     tumor infiltrating lymphocytes given with chemotherapy and interleukin-2 in patients with~     melanoma.~   "
123851|NCT01946360|"~     Blood will be collected after venepuncture from all patients for complete blood counts, Serum~     bilirubin (direct and indirect), aspartate aminotransferase, alanine aminotransferase,~     alkaline phosphatase, gamma glutamyl transferase, prothrombin time and INR, urea, creatinine,~     sodium, potassium, serum total protein and albumin, within 24 hours after admission and twice~     a week there after or as and when needed.~      Time line for blood tests and evaluation of clinical parameters & 13C-MBT~      For ALF patients:~      On days 0, 1, 3, and 7~      For ACLF patients:~      On days 0, 7 (week 1), 14(week 2), 28 (weeks 4)~      Blood tests would include:~      Serum bilirubin (total and direct), aspartate aminotransferase, alanine aminotransferase,~     alkaline phosphatase, gamma-glutamyltransferase, Serum proteins (total and albumin),~     prothrombin time & international normalized ratio (INR), Serum urea and creatinine, serum~     electrolytes, arterial ammonia and arterial blood gas analysis.~   "
128737|NCT01882348|"~     The proposed study is a Randomized Controlled Trial designed to test the sustainability of a~     previously developed, tested, effectively implemented tobacco control strategy—the CEASE~     intervention, employing state of the art tobacco dependence treatment for parents who smoke.~   "
123852|NCT01946347|"~     The aim of the study is to evaluate the effect of hyperinsulinemia and postprandial changes~     in plasma glucose and lipids concentrations on the endothelial function together with other~     metabolic parameters in patients with type 2 diabetes (T2D) and in healthy subjects.~      Hypothesis:~      Different changes in endothelial function to acute in vivo induced hyperinsulinemia and after~     the meal test will be found in patients with T2D compared to healthy subjects.~      A significant relationships between insulin sensitivity, selected adipokines intramyocellular~     fat content, hepatic fat content and high energy phosphates in soleus muscle will be~     documented in both groups.~   "
123853|NCT01946334|"~     The anorectal manometry is the gold standard in the evaluation of anorectal function.~      Several techniques are currently used (balloons, perfused catheters) and are always performed~     in the supine position.~      Few studies have reported the evaluation of sphincter function in the upright position,~     whereas symptoms of fecal incontinence occur in this position.~      Recently developed, high-resolution manometry, thanks to its many mechanical sensors, allows~     topographic analysis and evaluation of anorectal function more acurate. In addition, the~     rigid nature of the probe should allow stability measures / recording, which is not possible~     with probes perfused catheters example.~      We therefore propose to compare anal sphincter pressure in supine and standing, measured in~     high-resolution manometry.~   "
123854|NCT01946321|"~     During any period of rehabilitation it is important to select meaningful tests that; measure~     what you want, are responsive to changes in the patient's condition and, easy to use in the~     clinical settings. With an amputee such tests may help make sure that rehabilitation~     programmes and the prosthesis (artificial leg) provided are tailored for the individual. New~     prosthetic technology is continually being developed and the active amputee now demands more~     from their artificial limbs. Making sure that they get the right rehabilitation programmes~     and the most appropriate prosthesis will help them perform to their best.~      Thirty amputees who have recently undergone a lower limb amputation will be recruited into~     this study. They will be asked to complete 2 walking tests and 4 questionnaires that measure~     different aspects of their recovery from the comfort of the socket to their perceived ability~     to undertake everyday tasks. Each of the tests give a score or grade which represents the~     level of their ability, as judged by the test, at that given time point. The tests will be~     repeated at one and three weeks after delivery of their prosthesis, just before discharge~     from hospital and at 6 weeks post-discharge.~      By measuring the changes in the scores across these time points, and also how the amputees~     feel they have changed, it is hoped that it can be determined how responsive the tests are to~     objective measures of changes in the amputees abilities and also whether the tests are~     sensitive to the changes felt by the amputee. If it is shown we can more accurately link~     changes in the scores to the changes in the amputees abilities then Physiotherapy treatment~     programmes could be more accurately tailored to the individual amputee.~   "
123855|NCT01946308|"~     Babies born too soon, premature babies, can have complications following birth because their~     systems are immature. Hospitals help prevent deformities and delays in motor development by~     using therapeutic positioning to provide containment as they would experience in the womb.~     They also often have trouble eating. They have discomfort, are irritable, refuse to eat and~     cry because their digestive system is immature. The neonatal intensive unit can create stress~     and disrupt their sleep. Going from active to deep sleep is essential for infant brain~     development, learning and memory formation. Their sleep states early in life predict their~     developmental outcome. The purpose is to determine whether a conformational positioning~     system, one that can mold to the baby and contain him or her, will allow more time asleep in~     premature infants with feeding problems compared to the standard crib mattress. We~     hypothesize that the number of total sleep time will be longer and the number of arousals out~     of sleep lower when they are sleeping on the conformational positioning system compared to~     the mattress.~   "
123856|NCT01946295|"~     Objective of the trial is to study if famotidine add-on treatment is more effective than~     placebo add-on in reducing symptoms of schizophrenia among patients receiving insufficient~     response to ongoing antipsychotic treatment.~   "
123857|NCT01946282|"~     Through this program, the investigators will test a systematic colon cancer screening~     outreach strategy for increasing screening completion among uninsured patients, not~     up-to-date with screening. The intervention will consist of mailed screening invitations,~     with processes such as phone reminders to promote screening and evidence based follow up. All~     patients will be randomly assigned to receive mailed invitations to complete a home fecal~     immunochemical test (FIT). Some patients will be randomly assigned to receive a small~     financial incentive on completion of FIT testing.~   "
123858|NCT01946269|"~     The purpose of this study is to determine whether a goal-directed resuscitation therapy~     within the first 8 hours after major abdominal cancer surgery reduces postoperative~     complications compared to a standard therapy.~   "
123859|NCT01946256|"~     PREGNANT WOMEN IN ANTENATAL CLINIC WILL BE SCREENED FOR CHLAMYDIA TRACHOMATIS INFECTION WITH~     ENDOCERVICAL SWAB.THOSE THAT TEST POSITIVE AND SATISFY THE INCLUSION CRITERIA WILL BE~     COUNSELLED AND ENROLLED INTO THE STUDY AFTER OBTAINING INFORMED CONSENT.THE PARTICIPANTS WILL~     BE RANDOMISED INTO ONE OF THE TWO GROUPS.THE DRUGS WILL BE TAKEN FOR I WEEK AND THE SEXUAL~     PARTNER(S) WILL ALSO BE TREATED WITH DOXYCYCLINE FOR 1 WEEK. BARRIER CONTRACEPTION WILL ALSO~     BE USED DURING THE TREATMENT.THE SEXUAL PARTNERS WILL BE CONTACTED THROUGH TELEPHONE CALLS~     AND THE BENEFITS OF PARTICIPATING IN THE STUDY WILL BE EXPLAINED TO THEM. LATEX MALE CONDOM~     WILL BE GIVEN TO THE WOMEN. ALSO, FOLLOW-UP TELEPHONE CALLS WILL BE PUT ACROSS TO THEM DURING~     THE TREATMENT WEEK TO ENHANCE COMPLIANCE. A REPEAT ENDOCERVICAL SWAB WILL BE TAKEN 4 WEEKS~     AFTER TREATMENT TO CHECK FOR MICROBIOLOGICAL CLEARANCE. A STUDY PROFORMA WILL BE FILLED~     DURING THIS VISIT. THE DATA WILL BE ANALYSED USING STATISTICAL PACKAGE FOR SOCIAL SCIENCES~     VERSION 17.~   "
123860|NCT01946243|"~     The overall objective of the study is to assess the feasibility of implementing a~     quantitative process of florbetapir F 18 scan interpretation. The hypothesis is that the use~     of quantitative analysis will increase the accuracy of florbetapir F 18 scan interpretation.~   "
124047|NCT01943812|"~     The aim of this study is to compare two FET protocols by modifying the substituted FET cycle~     in order to maintain a higher ongoing positive pregnancy rate and thus reduce the early~     pregnancy loss.~      Hypothesis: adding GnRH-agonist to the substituted cycle in FET treatment reduces the early~     pregnancy loss.~   "
123861|NCT01946230|"~     The mortality rate of oral cancer in Taiwan is still high with no decrease. One of the~     reasons result in these situations is the patent visits hospital for treatment in late stage~     of oral cancer. Recently, the government makes effort in oral cancer screening to find oral~     potentially malignant disorders (OPMD) early. However, there is no conscience in treatment~     strategies of OPMD up to now. In this study, we will set a OPMD data bank, and use the cases~     to find out the potential biomarker, which is able to predict the oral cancer malignant~     transformation. Sixty OPMD with oral cancer transformation will be recruited, and 60 OPMD~     with no oral cancer malignant transformation will also be enrolled as the disease control~     group. Besides, 20 normal cases and 60 oral cancer cases resulting from previous OPMD will be~     collected. All those groups will detect the expression of p62/SQSTM1 to investigate the~     possibility that p62/SQSTM1 as a biomarker to predict the malignant transformation of OPMM,~     and a guideline to treat or not to treat OPMD.~   "
123862|NCT01946217|"~     This pilot research trial studies factors affecting patient participation in Acquired Immune~     Deficiency Syndrome (AIDS) Malignancy Clinical Trials Consortium clinical trials. Determining~     how patients makes decisions about participating in a clinical trial may help doctors plan~     clinical trials in which more patients are willing to participate and are satisfied with~     their decision to participate.~   "
123863|NCT01946204|"~     The purpose of this study is to evaluate the efficacy and safety of apalutamide in adult men~     with high-risk non-metastatic castration-resistant prostate cancer.~   "
123864|NCT01946191|"~     The purpose of this study is to test whether online tracking tools and weight maintenance~     coaching visits for patients and real-time electronic progress reports for primary care~     providers (PCPs) [Continued Coaching (CC)] will support more successful weight maintenance~     than online tracking tools alone [Tracking Only (TO)] in a group of primary care patients who~     have lost ≥ 5% of their body weight.~   "
123865|NCT01946178|"~     The Mirabilis High-Intensity Focused Ultrasound (HIFU) Treatment System delivers therapeutic~     focused ultrasound energy to the uterus under integrated ultrasound imaging guidance to offer~     non-invasive treatment for uterine fibroids. The purpose of this clinical study is to assess~     the initial safety and performance of the Mirabilis HIFU Treatment System for transabdominal~     treatment of uterine fibroids in eligible women who are scheduled to undergo hysterectomy~     following treatment with the device or who are seeking relief from fibroid-related symptoms.~   "
123866|NCT01946165|"~     The goal of this clinical research study is to learn if adding the combination of abiraterone~     acetate and prednisone with or without enzalutamide to hormonal therapy can help to control~     prostate cancer when given before surgery. The safety of the drug combination will also be~     studied.~   "
123867|NCT01946152|"~     The goal of Part 1 of this clinical research study is to find the highest tolerable dose of~     pomalidomide that can be given in combination with dexamethasone and neupogen (filgrastim) to~     patients with relapsed or refractory MM.~      The goal of Part 2 of this study is to learn if the drug combination can help to control MM.~      The safety of this drug combination will be studied in both parts.~      This is an investigational study. Pomalidomide is FDA approved and commercially available for~     the treatment of multiple myeloma in patients whose disease has not gotten worse within 60~     days after receiving at least 2 prior therapies (including lenalidomide and bortezomib).The~     combination of pomalidomide, dexamethasone, and filgrastim to treat MM is investigational.~      The study doctor can explain how the study drug(s) are designed to work.~      Up to 55 participants will take part in this study. All will be enrolled at MD Anderson.~   "
123868|NCT01946139|"~     This clinical trial studies anal human papillomavirus (HPV) tests in screening for cell~     changes in the anus in patients with human immunodeficiency virus (HIV). Screening tests may~     help doctors find cancer cells early and plan better treatment for anal cancer. Completing~     multiple screening tests may help find the best method for detecting cell changes in the~     anus.~   "
123869|NCT01946126|"~     This study is a retrospective chart review in patients diagnosed with headache or migraine to~     evaluate treatment patterns and diagnosis.~   "
123870|NCT01946113|"~     Acute renal failure is a common complication in intensive care unit patients. In 10% of cases~     renal replacement therapy becomes necessary. Current devices have increase filter patency and~     efficacy. However, magnesium, calcium and phosphate are eliminated as well. However, the~     extend of this elimination hase not been quantified. Thus, we want to~        1. record retrospectively how often abnormal values for phosphate, magnesium and calcium~          occurred during routine renal replacement therapy in 2011 and 2012.~        2. prospectively evaluate the same parameters during routine treatment in 2013 and 2014~   "
123871|NCT01946100|"~     To gather preliminary safety and outcome data for the multimodality treatment of lung~     adenocarcinoma in the setting of multifocal BAC.~   "
123872|NCT01946087|"~     The aim of this study is to investigate whether RIPC protects the heart against ischemia~     reperfusion injury on the concentrically hypertrophied myocardium~   "
123873|NCT01946074|"~     This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and~     preliminary efficacy of ABT-165 in subjects with advanced solid tumors. The early clinical~     development plan for ABT-165 is based on the activity demonstrated in preclinical models.~   "
123874|NCT01946061|"~     Patients with advanced gastric cancer have showed poor prognosis. Only 81% of the patients~     could underwent curative surgery. In those, about 60% of patients would survive after 5 years~     from the surgery. As a result, role of chemotherapy has been increased. In ACTS-GC trial, S-1~     adjuvant therapy after D2 gastrectomy increased overall survival rate in advanced gastric~     cancer patients. However, subgroup analysis showed that S-1 adjuvant therapy was insufficient~     in patients with stage III or IV (according to the AJCC 6th criteria) gastric cancer. In~     addition, CLASSIC trial demonstrated that oxaliplatin plus capecitabine adjuvant therapy~     could increase disease-free survival after D2 gastrectomy in advanced gastric cancer~     patients. Notwithstanding these trial, optimal adjuvant regimen of advanced gastric cancer~     has not been established. We aimed to evaluate efficacy of S-1 plus oxaliplatin as adjuvant~     chemotherapy after D2 gastrectomy in stage III (according to the AJCC 7th criteria) gastric~     cancer patients.~   "
123875|NCT01946048|"~     The aim of the present study is to investigate safety and efficacy of intramyocardial~     implantation of allogeneic mesenchymal stem cells in patients with ischemic cardiomyopathy .~   "
123876|NCT01946035|"~     Allergic rhinitis (allergic inflammation of the nose) is a common medical condition which is~     known to seriously decrease quality of life, aggravate preexisting conditions particularly~     asthma, carry significant medical treatment costs and be responsible for reduced work~     productivity and lost school days. A significant symptom of the condition, nasal blockage,~     remains difficult to treat even when using nasal corticosteroids. Decongestant medications~     act on the blood vessels in the nose and have an immediate effect in clearing a blocked nose~     but if used for more than seven days a more severe rebound congestion of the nose develops.~      In this study, the investigators aim to assess the effects of doxazosin, a drug which is~     currently used to treat high blood pressure and symptoms of prostate enlargement, to find out~     if it has an effect on nasal blockage.~   "
123877|NCT01946022|"~     This study is intended to evaluate ovarian cells after being submitted do different in vitro~     fertilization protocols. The investigators will analyze hormones secretion and intracellular~     mechanisms of these cells comparing the GnRH agonist protocol and the GnRH antagonist~     protocol.~   "
123878|NCT01946009|"~     Cidofovir could be an effective drug for the treatment of Anal Intraepithelial~     Neoplasia(AIN).~   "
123879|NCT01945996|"~     In this study, an existing mobile health intervention to improve diabetes self-management~     will be combined with a social support module and tested for feasibility. The investigators~     hypothesize that this combination will be feasible and acceptable to both patients and their~     loved ones.~   "
123880|NCT01945983|"~     Current septic shock guideline recommends fluid resuscitation as the first treatment.~     Vasopressors, including norepinephrine is recommended to start after achieve adequate fluid~     therapy. This can cause a certain duration of systemic hypotension before vasopressor is~     commenced. Initiation of norepinephrine together with fluid therapy soon after diagnosis of~     septic shock may increase blood pressure quicker than start treatment with intravenous fluid~     alone. The rapid restoration of perfusion pressure may improve septic shock outcome.~   "
123881|NCT01945970|"~     Epidemiological studies indicate that regular consumption of three cups of black tea per day~     reduces the risk of stroke or myocardial infarction. In a number of previous nutrition~     intervention studies tea has been shown to improve vascular function as assessed by Flow~     Mediated Dilation (FMD).~   "
123882|NCT01945957|"~     This is a 4 part study:~      Phase 1a. -functional magnetic resonance imaging (fMRI) ( with oxytocin 24 IU vs. placebo =~     oxytocin 0 IU) - funded by grant #U54 HD079124-01, Phase 1b-eye-tracking(oxytocin 24 IU vs.~     placebo = oxytocin 0 IU), Phase 2a. fMRI (oxytocin 8 IU vs. oxytocin 40IU), Phase 2b.~     -eye-tracking (oxytocin 8IU vs. oxytocin 40IU). Time course of effect will also be assessed~     within session.~   "
123883|NCT01945944|"~     Children who need to be on a ventilator often have thick secretions/mucus in their lungs.~     These secretions can obstruct the breathing tube and their windpipe, which can worsen lung~     function and prolong the need for the ventilator. Hypertonic saline is a medicine that is~     used to thin out secretions in patients with cystic fibrosis (and other conditions). We~     hypothesize that having children on a ventilator inhale this medication will shorten the~     amount of time that they need to be on the ventilator.~   "
123884|NCT01945931|"~     The purpose of this trial is to determine if the safe delivery smartphone application~     distributed to health workers in Ethiopia will decrease perinatal mortality and the incidence~     of postpartum haemorrhage. It is also the purpose to determine if the safe delivery~     smartphone application distributed to health workers in Ethiopia will increase health workers~     knowledge and skills in intra-partum management of active management of third stage labour 2)~     treatment of post-partum haemorrhage 3) manual removal of placenta and 4) neonatal~     resuscitation.~   "
123885|NCT01945918|"~     This project will test different ways of helping primary care practices to do a better job of~     self-management support (SMS) for their patients with diabetes.~   "
123886|NCT01945905|"~     -  Tuberculosis ( TB ) remains a major global public health problems and actions to ensure~          the diagnosis and complete treatment of all cases is the priority for the control of~          this disease. Despite the availability of effective anti-tuberculosis medications, there~          are still high levels of nonadherence to treatment. The nonadherence increases the~          morbidity and mortality of patients, decreases the cure rate, increases the community~          transmission and the increase of chronically ill patients enables the emergence of multi~          - drug resistant and increases treatment costs.~        -  Despite the knowledge about different forms of cost-effective delivery of DOT (directly~          observed treatment), recognition of the need to establish the DOT strategy related to~          the context from local studies, in Colombia and in Cali we hadn't had made studies~          similar than this one that establish the cost and results of the current DOT delivery~          strategy and to identify other ways to improve adherence and cure rate for the TB~          patients at reasonable cost for both: health services and families~        -  Therefore, this research aims to compare the cost -effectiveness of current DOT delivery~          method with an alternative extra- institutional delivery of anti -TB treatment in urban~          areas of Cali. A cost-effectiveness study was conducted from the institutional and~          familiar perspective with prospective information collection.~   "
123887|NCT01945892|"~     To analyze macula edema formation after cataract surgery called Irvine-Gass-Syndrome.~   "
123888|NCT01945879|"~     Venous thromboembolic events are considered to be a prognostic negative factor and small~     studies showed astonishing survival advantages using heparin as prophylactic treatment to~     prevent venous thromboembolic events. Based on these assumptions our Charité - Onkologie~     (CONKO) study group planned to conduct a randomized trial to investigate the impact of low~     molecular weight heparin (LMWH) in a prospective setting in patients with advanced pancreatic~     cancer undergoing first line therapy, the CONKO-004 trial. During the preliminary stages we~     had to undertake a pilot trial to get information on safety and feasibility of combined~     chemotherapy with simultaneous treatment of the LMWH Enoxaparin in patients with advanced~     pancreatic cancer who are at high risk of gastrointestinal bleeding due to local cancer~     spread.~   "
124048|NCT01943799|"~     This study will evaluate the safety and efficacy of GS-4774 in adults with chronic hepatitis~     B (CHB) viral infection who have been virally suppressed with an oral antiviral medication.~     Participants will be randomized in a 1:2:2:2 ratio to the treatment arms for 20 weeks.~   "
123889|NCT01945866|"~     Although anti-vascular endothelial growth factor (VEGF) therapy is generally effective as~     treatment for center-involved diabetic macular edema (DME), a substantial proportion of~     anti-VEGF-treated eyes with DME do not achieve vision of 20/20 or complete resolution of~     retinal thickening. Indeed, over 50% of ranibizumab-treated eyes did not achieve a 2 or more~     line improvement in visual acuity from baseline at 2 years in Protocol I, a previous DRCR.net~     (Diabetic Retinopathy Clinical Research Network) study. Furthermore, 27% of~     ranibizumab-treated eyes still had central subfield (CSF) thickness on time-domain optical~     coherence tomography (OCT) ≥ 300 at 1 year, and more than 40% of ranibizumab-treated eyes did~     not achieve complete resolution of retinal thickening (< 250 microns) by 2 years. Thus, there~     is a need for alternative or additional treatments that will improve vision by reducing~     retinal edema in eyes with persistent DME following previous anti-VEGF therapy. Intravitreal~     steroid is not as efficacious as ranibizumab in eyes with DME overall, but it has been shown~     to have a positive effect for DME in some eyes and might add benefit in eyes that are already~     receiving anti-VEGF.~      The main objective of this study is to assess the short-term effects of combination~     steroid+anti-VEGF therapy on visual acuity and retinal thickness on OCT in comparison with~     that of continued anti-VEGF therapy alone in eyes with persistent central-involved DME and~     visual acuity impairment despite previous anti-VEGF treatment. This study will provide~     important information for the design of a future confirmatory phase III clinical trial on the~     efficacy of combination steroid and anti-VEGF in eyes with persistent DME and vision~     impairment following previous anti-VEGF therapy. The primary outcome for efficacy will be the~     mean change in visual acuity at 24 weeks.~      Each study eye is required to complete a 12-week run-in phase. The run-in phase will identify~     study eyes that truly have persistent DME despite anti-VEGF therapy by requiring an~     additional 3 injections while also collecting standardized visual acuity and OCT~     measurements. At the enrollment, 4-week and 8-week visits of the run-in phase, enrolled eyes~     will receive an intravitreal injection of ranibizumab 3mg. Then at the 12-week run-in visit,~     if the eye still has persistent DME, it will be randomized to receive either intravitreal~     sham+intravitreal ranibizumab 0.3 or intravitreal dexamethasone+intravitreal ranibizumab 0.3~     injections. The randomized study duration is 24 week, during which a protocol visit takes~     place every month. The combination injections of sham+ranibizumab or dexamethasone~     +ranibizumab will be given at the randomization visit (baseline) and at the 12-week visit~     after randomization. In between, an intravitreal injection of ranibizumab only will be given~     to study eyes at the 4, 8, 16 and 20 week visits.~   "
123890|NCT01945853|"~     This is a pilot study to identify the degree of grey and white matter involvement in patients~     with Amyotrophic Lateral Sclerosis (ALS) utilizing non-invasive techniques. The imaging to be~     utilized will be the 7 Tesla (7T) magnetic resonance imaging (MRI) of the brain. These~     results will be correlated to the ALS Functional Rating Scale - Revised (ALSFRS-R) score to~     assess if any changes in MRI can be predictive in the disability of the ALS patients at~     baseline and at 6 month intervals. The participants will be asked to return every 6 months~     for a neurological examination, ALSFRS-R assessment, measurement of the vital capacity and~     MRI as outlined above to monitor progression of the disease.~   "
123891|NCT01945840|"~     The purpose of this study is to assess whether the changes in gut hormones seen following~     Roux en Y Gastric Bypass surgery are responsible for some of the beneficial effects seen~     post-operatively.~   "
123892|NCT01945827|"~     The primary objective of this registry is to assess the safety and angiographic outcomes of~     endovascular treatment of intracranial aneurysms using the DeltaMaxx Microcoil System.~   "
123893|NCT01945814|"~     In this study, investigators are trying to see if infusion of T cells (called CTLs) will~     prevent or treat cytomegalovirus (CMV), Epstein Barr Virus (EBV) and adenovirus (AdV)~     reactivation or infection.~      Patients with blood cell cancer, other blood disease or a genetic disease may receive a stem~     cell transplant. After receiving transplant, they are at risk of infections until a new~     immune system to fight infections grows from the cord blood cells. In this study,~     investigators are trying to give special cells called T cells. These cells will try to fight~     viruses that can cause infection.~      Investigators will test to see if blood cells from donor that have been grown in a special~     way, can prevent patients from getting an infection. EBV, AdV and CMV are viruses that can~     cause serious life-threatening infections in patients who have weak immune systems after~     transplant.~      T lymphocytes can kill viral cells but normally there are not enough of them to kill all the~     virus infected cells after transplant. Some researcher have taken T cells from a person's~     blood, grown more of them in the laboratory and then given them back to the person during a~     viral infection after a bone marrow transplant. Some of these studies have shown a positive~     therapeutic effect in patients receiving the CTLs after a viral infection in the~     post-transplant period.~      Investigators will grow these cells from donor in the laboratory in a way that will train~     them to recognize and remove viruses when the T cells are given after a transplant. Since~     most donors have previously been infected with EBV, CMV, and adenovirus, investigators are~     able to use their T cells that remember these viruses to grow the CTLs. However, they now~     also have a new way of growing CTLs from donors who have not been infected with CMV.~   "
123894|NCT01945801|"~     This study evaluates the intervention of the 1) sodium-restricted diet, or 2) diuretic, or 3)~     placebo pill in the treatment of obstructive sleep apnea in adults.~   "
123895|NCT01945788|"~     The primary objective of this study is to compare efficacy and safety of two formulations of~     teriparatide 20 mcg/day plus calcium and vitamin D in postmenopausal women with osteoporosis.~   "
123896|NCT01945775|"~     The purpose of this open-label, 2:1 randomized phase III trial is to compare the safety and~     efficacy of talazoparib (also known as BMN 673) versus protocol-specific physician's choice~     in patients who have locally advanced and/or metastatic breast cancer with germline BRCA~     mutations.~   "
123897|NCT01945762|"~     This is a European multinational, multicenter, non-interventional (observational) and~     prospective study. It is carried on to confirm in real life conditions the benefit/risk of~     vandetanib (CAPRELSA™) 300 mg, both in RET negative and RET positive patients with~     symptomatic, aggressive, sporadic, unresectable, locally advanced/metastatic MTC.~   "
123898|NCT01945749|"~     Osteoarthritis (OA) of the knee is a very common chronic joint disorder associated pain and~     disability. As no cure exists, management aims to reduce pain, improve function, and enhance~     quality of life. The recommended hierarchy of management should consist of exercise in first~     line, then the add-on of drugs if necessary, and ultimately, if necessary, surgery.~      The effect size of exercise therapy is of the same magnitude as most pharmacological~     treatments but is often without adverse effects. Local pharmacological treatment of the~     afflicted knee joint is recommended by means of intra-articular injections of~     corticosteroids, which is considered as a standard medical treatment of knee OA and are~     included in established guidelines for management of knee OA. While the two treatment~     approaches have been investigated separately in numerous clinical trials, the efficacy of a~     combined pharmacological and non-pharmacological approach is not known, despite the high rank~     of such combined treatment approach on the recommended hierarchy of management.~      The purpose of this study is to assess the effects of exercise therapy in combination with~     intra-articular corticosteroid injections on patient reported pain and function in patients~     with knee OA.~      The hypothesis is that the combined treatment approach (exercise therapy preceded by~     intra-articular injection of corticosteroid) enhances the clinical outcome compared to~     exercise therapy preceded by a placebo injection.~   "
123899|NCT01945736|"~     The purpose of this study is to learn more about how the study drug, methadone, prescribed by~     an infant's or child's physician as part of standard medical care, is processed in children~     and young adults. While this drug is used extensively in infants and children, it has not~     been extensively studied in this population.~      Physicians do not have very much information on how long it takes for methadone to be removed~     from the blood circulation and passed out of the body. Physicians need more information to~     guide how much and how often we should give methadone to children/young adults to ensure they~     get the maximum effect with the minimum amount of drug. During this research study, the study~     team will collect information about how this drug is processed in infants and children.~   "
123900|NCT01945723|"~     Tissue characterization will be performed, from different regions of the gastrointestinal~     tract in healthy volunteers.~   "
123901|NCT01945710|"~     Study E7389-E044-112 is a Phase 1 study designed to assess the safety, tolerability and~     preliminary efficacy of E7389 liposomal formulation (E7389-LF) in patients with solid tumors.~     This dose-escalation study will determine the maximum tolerated dose, dosing schedules~     tested, the dose schedule regimen with a more favorable tolerability profile, and a~     preliminary indication of efficacy.~   "
123902|NCT01945697|"~     The aim of this study is to evaluate the association between several methylated genes and~     oral cancers. A prospective case control trial is designed with sample size estimated at~     least 160 cases. It is expected to enroll at least 100 subjects with precancerous lesion or~     oral cancer, and ~60 subjects with normal oral mucosa. This study is approved by the National~     Taiwan University Hospital Research Ethics Committee. After signing the informed consent, all~     of the subjects will receive an intraoral examination and the oral epithelial cells will be~     collected. If abnormal oral lesion is observed, it will be photographed, and the biopsy will~     be performed to confirm the diagnosis. For methylated gene detections, the gDNA will be~     extracted from the collected cells and standardized assay will be performed. Clinical~     sensitivity and specificity for these methylated genes will be evaluated.~   "
123903|NCT01945684|"~     Purpose: This study is a Randomized, Double Blind, Multi-center, Active Drug Controlled,~     Phase III Clinical Trial to Compare the Safety and Efficacy of DWP450 Versus Botox® in~     Treatment of Post Stroke Upper Limb(wrist, finger, elbow, thumb)Spasticity.~   "
123904|NCT01945671|"~     Obese women have a higher prevalence of infertility than their lean counterparts. Obesity is~     a risk factor for anovulation , including in response to gonadotropin treatment .Further,~     even in women who are cycling regularly, obesity is associated with increased~     time-to-pregnancy and decreased chance of natural pregnancy.~      During obesity or periods of overnutrition, lipid accumulates in nonadipose tissues, notably~     skeletal muscle, liver, heart, and pancreas due to cellular uptake of exogenous fatty acids,~     triglycerides, and cholesterol as well as de novo lipogenesis in response to elevated~     glucose. The accumulation of intracellular lipid leads to high levels of free fatty acids~     that are subject to oxidative damage and the formation of cytotoxic and highly reactive lipid~     peroxides, which ultimately are detrimental to intracellular organelles, particularly the~     endoplasmic reticulum (ER) and mitochondria. Exposure of the ER to high levels of free fatty~     acids and lipid peroxides causes structural alterations that perturb ER function and lead to~     accumulation of unfolded proteins and calcium release. Failure of the UPR to reestablish ER~     homeostasis can lead to apoptosis .When mitochondria are exposed to high levels of free fatty~     acids, these can become oxidized by mitochondrial reactive oxygen species, forming lipid~     peroxides that damage essential proteins and uncouple mitochondrial function. This results in~     mitochondrial damage, which can cause further accumulation of lipids that cannot be~     catabolized, disrupted cellular homeostasis, and ultimately apoptosis .~      The cellular mechanisms by which obesity causes decreased conception rates are not known.~     Based on extensive evidence of obesity-induced lipotoxicity in other cells, it was~     hypothesized that obesity results in the activation of lipotoxicity pathways in the ovary. It~     was shown that lipid accumulation, ER stress, mitochondrial dysfunction, and apoptosis occur~     in ovarian cells and the oocyte in response to a high-fat diet.~      The aim of our study was to evaluate the influence of high BMI on oocytes, granulose cells~     and metabolites in the follicular fluid.~   "
123905|NCT01945658|"~     The main objective of this study is to determine what is the vitamin D status in Israeli~     women undergo ART. We want to evaluate the influence of hyper Vitamin D level and low vitamin~     D level on IVF -ICSI cycles. We will evaluate as well the influence of increased estradiol~     level in IVF-ICSI cycles on peripheral vitamin D.~      We plan to follow vitamin D in infertile women undergoing IVF treatment for various~     indications, at baseline, during and after controlled ovarian hyperstimulation. Their levels~     will be measured at baseline (when they first present for basic investigations at our~     clinic), during the down-regulation phase of their treatment (if their protocol has a~     down-regulation phase), at each follow-up visit during stimulation (when they are asked to~     present for measurement of their estradiol (E2) levels), as well as at the conclusion of~     their treatment (i.e. the day of their pregnancy test). Along with endocrinology profiles, we~     will also record all the details of treatment outcomes in terms of embryo quality,~     implantation and clinical pregnancy rates. We also intend to perform follow-up studies of~     pregnancy outcomes.~   "
123906|NCT01945645|"~     A pre-randomized study in primary health care was designed to investigate health education in~     a subpopulation extracted from general practitioners (GPs) in one Danish county in the~     treatment arm of the ADDITION (Anglo-Danish-Dutch Study of Intensive Treatment in People with~     Screen-Detected Diabetes in Primary Care) study, DK. The overall objective of the 'Ready to~     Act' health education programme was to support the participants' competences in daily life~     and act appropriately with respect to their dysglycaemic condition. The achievement of action~     competence involved four learning objectives: intrinsic motivation, informed decision-making,~     action experience and social involvement. The programme was delivered in primary care~     settings (health centre or GP surgeries) by nurses, dieticians, physiotherapists and GPs.~   "
123907|NCT01945632|"~     In a clinical trial of 19 patients, 44 single-rooted teeth will be randomly assigned to one~     of four groups for: 1) no treatment, 2) manual root planing with curettes; 3) root planing~     with piezoelectric ultrasonic scraper [PU]; or 4) root planing with vertically oscillating~     ultrasonic device [VOU]. Post-treatment, the teeth will be extracted and their topography~     analyzed in 124 observations with white light confocal microscopy, measuring the roughness~     parameters Rp, Rv, Rt, Ra, Rq, Rku, and Rsk.~   "
123948|NCT01945099|"~     Closed loop artificial pancreas systems have been under development for the control of~     blood sugars in those living with diabetes. These systems consist of a continuous glucose~     sensor, which sends a signal to a computer program that automatically determines how much~     insulin to give. The computer program then tells an insulin pump to deliver the insulin.~     While such systems have been tested under a number of conditions, post-meal blood sugars are~     difficult to control. Specifically, we will be looking to see if using hyaluronidase improves~     the ability of the closed loop artificial pancreas to better respond to meal related highs~     and lows.~   "
123908|NCT01945619|"~     Subjects have a type of blood cell cancer, other blood disease or a genetic disease for which~     they received a stem cell transplant. After transplant while the immune system grows back the~     subjects have an infection with one or more of three viruses - Epstein Barr virus (EBV),~     cytomegalovirus (CMV) or adenovirus - that has persisted or come back despite standard~     therapy.~      Adenovirus is a virus that causes symptoms of a common cold normally but can cause serious~     life-threatening infections in patients who have weak immune systems. It usually affects the~     lungs and can cause a very serious pneumonia, but it can also affect the gut, the liver, the~     pancreas and the eyes.~      CMV is a virus that can also cause serious infections in patients with suppressed immune~     systems. It usually affects the lungs and can cause a very serious pneumonia, but it can also~     affect the intestinal tract, the liver and the eyes. Approximately 2/3 of normal people~     harbor this virus in their body. In healthy people CMV rarely causes any problems because the~     immune system can keep it under control. If the subject and/or the subject's donor are~     positive for CMV, s/he is at risk of developing CMV disease while his/her immune system is~     weak post transplant.~      EBV is the virus that causes glandular fever or kissing disease. It is also normally~     controlled by a healthy immune system, but when the immune system is weak, it can cause~     fevers, enlarged lymph nodes and sometimes develop into a type of cancer called lymphoma.~      This treatment with specially trained T cells (called CTLs) has had activity against these~     viruses when the cells are made from the transplant donor. However, as it takes 2-3 months to~     make the cells, that approach is not practical when the subject already has an infection. We~     want to find out if we can use CTLs which have already been made from another donor that~     match the subject and his/her donor as closely as possible and if the CTLs will last in the~     body and have activity against these viruses.~      In a recent study these cells were given to 50 patients with viral infections post transplant~     and over 70% had a complete or partial response. The purpose of this study is to make CTL~     lines leftover from that previous study available to patients with viral infections that have~     not responded to standard treatments.~      These virus-specific CTLs are an investigational product not approved by the FDA.~   "
123909|NCT01945606|"~     This is a study to investigate the safety and tolerability of the partial A1 agonist~     BAY1067197 in patients with chronic heart failure. BAY1067197 will be applied as a single~     dose of 30 mg in addition to standard therapy including a beta-blocker. The aim of the study~     is to assess if a single oral dose of 30 mg BAY1067197 is well tolerated when given on top of~     standard therapy for heart failure, particularly ß-blocker treatment.~   "
123910|NCT01945593|"~     To continue the evaluation of the safety and efficacy of prophylaxis with BAX 855 for the~     prevention and treatment of bleeding episodes in previously treated patients (PTPs) (children~     and adults from 0 to 75 years of age) with severe hemophilia A.~   "
123911|NCT01945580|"~     To compare transvaginal repair with a biologic graft to traditional native tissue repair in~     women surgically treated for anterior and/or apical pelvic organ prolapse.~   "
123912|NCT01945567|"~     The posterior subthalamic area holds promise as a target region for deep brain stimulation in~     tremor and Parkinson's disease. Using the magnetic resonance-directed implantable guide tube~     surgical technique, subregions of the posterior subthalamic area can be individually~     targetted on a single electrode lead trajectory. The hypothesis is that the caudal zona~     incerta may provide improved control of movement disorder symptoms than the more commonly~     stimulated dorsal zona incerta.~   "
123913|NCT01945554|"~     The purpose if this study is to assess the response to nerve root infiltration therapy in~     patients with cervical or lumbar disc herniations.~   "
123914|NCT01945541|"~     The purpose of this study is to evaluate a recently developed device, which measures body~     composition (i.e. the water content of the body) in the perioperative setting. Specifically~     the investigators will test the hypothesis, that extracellular water content after surgery~     correlates to the amount of intraoperative infusion and positive fluid balance. Furthermore~     the investigators will test, if preoperative evaluation of body water helps to determine~     intraoperative fluid requirements and to guide fluid administration.~   "
123915|NCT01945528|"~     Background Tendinopathy is a difficult problem to manage and can result in significant~     patient morbidity. Currently, the clinical use of PRP in painful tendons is widespread but~     its efficacy remains controversial. Current experimental research postulates different~     efficiency among PRP formulations.Recent reviews showed that most clinical studies in~     tendinopathies have been performed with L-PRP. The investigators aim to examine the efficacy~     of pure-PRP in the management of epicondylitis.~      The investigators hypothesized that pure PRP associated to needling intervention can enhance~     tendon healing in epicondylitis, improve function and reduce pain.~      Methods and design Randomized double blind controlled trial, a total of 80 patients will be~     randomly allocated into one of two groups: PRP or control. Interventions: PRP group,~     ultrasound (US)guided needling associated to delivery of multiple PRP depots each alternate~     week for a total of two interventions. Control Group: US-guided needling with lidocaine each~     alternate week for a total of two interventions. Main outcome measure: Changes in pain and~     activity levels, as assessed by Disabilities of the Arm, Shoulder and Hand (DASH)outcome~     measure score, before and six months after intervention.The primary end-point is 25%~     reduction in DASH. The investigators will compare the percentage of patients, in each group,~     that achieve a successful treatment defined as a reduction of at least 25% in the DASH score.~      Secondary outcome measures:Changes in pain and function as assessed by DASH and changes in~     pain as assessed by the visual analogue scale (VAS)at the 3, 6 and 12 month follow-up.~     Changes in sonographic features and neovascularity at 3, 6 and 12 months.~   "
123916|NCT01945515|"~     1. Study objective To evaluate the effect of robotic-assisted gait training combined with~          transcranial direct current stimulation (tDCS) as compared to that of robotic-assisted~          gait training on gait function of chronic stroke patients~        2. Subjects chronic stroke patients with gait impairment~        3. Methods~             -  Group 1: Robotic-assisted gait training with anodal tDCS (45 min)~             -  Group 2: Robotic-assisted gait training with sham tDCS (45 min)~             -  Duration of treatment: 2 weeks, 5 times a week~             -  Evaluation: Baseline, 1 day after the treatment, 4 weeks after the treatment~   "
123917|NCT01945502|"~     The purpose of this study is to assess the efficacy of three different pharyngeal packing~     during routine rhinologic surgery in the prevention of postoperative nausea and vomiting, and~     to evaluate the influence of pharyngeal packing on postoperative throat pain.~   "
123918|NCT01945489|"~     This is a study to evaluate the efficacy and safety of onabotulinumtoxinA (BOTOX®) compared~     with placebo, in achieving a 100% reduction in urinary incontinence in patients with~     overactive bladder (OAB) not properly managed with an anticholinergic.~   "
123949|NCT01945086|"~     The purpose of this study is to assess the safety and effectiveness of 2 doses of ustekinumab~     compared with placebo (inactive medication) in adult Japanese participants with severe atopic~     dermatitis.~   "
124199|NCT01941836|"~     The purpose of this research study is to see how ETC-1002 is tolerated in the body, to~     measure the amount of ETC-1002 in the blood, and to determine how ETC-1002 affects the level~     of LDL-cholesterol (bad cholesterol) and other markers of health and disease in blood and~     urine in patients with elevated LDL-cholesterol with or without statin intolerance.~   "
123919|NCT01945476|"~     Normally, higher levels of preoperational stress or anxiety affect behavior and recovery~     after the operation. Moreover, patients undergoing mastectomy are usually young women, and~     this demographic is known to experience higher levels of stress and anxiety than any other.~     Anesthetizing patients involves more than just anesthesia in operation; it also includes all~     of the preoperative treatments for optimizing a patient's condition and promoting quick~     postoperative recovery. Pharmacological premedication for anxiolysis or amnesia before~     anesthesia has been a common means of sedation that many studies have investigated. However,~     such studies have focused on alleviating patients' anxiety and on how far patients can obey~     induction for sedation; there has been no research on post-operational prognoses, the~     ultimate purpose of reducing anxiety.~      The well-known effect of pharmacological premedication is to reduce the capacity of the~     anesthetic. However, it is not confirmed whether this effect leads to better recovery after~     anesthesia, as this question has not been researched. Furthermore, recently some have argued~     strongly that premedication actually prolongs recovery and that it does not need to be~     applied to every patient. Recently, therefore, the use of pharmacological premedication has~     been left to the discretion of institutes or doctors in many cases.~      Among types of premedication, midazolam belongs to the class of short-acting benzodiazepines~     and is frequently used, as it induces meaningful anterograde amnesia and causes fewer~     aftereffects such as respiratory problems. In addition, its effects have already been~     demonstrated. However, research on the improvement of functional health after~     anesthesia—i.e., patients' quick return to normal life—is still poor and needs to be~     advanced.~      When measuring the degree of recovery, recent studies tend to focus on measuring how quickly~     patients are able to return to normal life rather than the recovery of specific symptoms. To~     this end, the most widely used method is the Quality of Recovery 40 (QoR-40) survey. It has a~     total of 40 items, which are classified into five categories: emotional state, physical~     comfort, psychological support, physical independence, and pain. Questions are answered using~     a 5-point scale, with 1 being worst and 5 being best. It takes 6.3 minutes on average to~     complete, and its test-retest reliability, internal consistency, and split-half coefficient~     have led it to be recognized as the most effective survey method. Moreover, it has been used~     in many studies investigating how the type of operation, method of anesthesia, additional~     medication, and gender affect anesthesia and the operation. Its validity for such research~     has been verified.~      Therefore, investigators can investigate the degree of postoperational functional recovery~     through the QoR-40 by comparing cases in which an operation is performed with or without~     midazolam.~   "
123920|NCT01945463|"~     Breast augmentation surgery is currently the most common elective plastic surgery performed~     in the US. With regards to the surgical technique, there are 4 incisional sites available for~     breast augmentation, each with its advantages and disadvantages: Axillary, Periareolar,~     inframammary, and umbilical. The implant is inserted in either a subglandular (beneath breast~     tissue), submuscular (underneath the Pectoralis Major), or dual-plane (combination of both)~     manner.~      Echocardiography is the most commonly used diagnostic test in cardiology for the evaluation~     of cardiac structure and function. Its use has increased dramatically in the last decades. We~     have encountered three women with congenital heart disease who have undergone breast~     augmentation, and their echocardiographic images were significantly limited after the~     implantation. There is only one case report in the medical literature suggesting that breast~     implants interfere with echocardiographic views .~      The underlying physical property of the silicone breast implants that causes interference~     with the ultrasound beam during echocardiographic examination is not known and has not been~     studied. Similar to air in the lung but to a lesser degree, silicone breast implants appear~     to prevent penetration of ultrasound beams. The poor penetration appears to be persistent and~     unrevealing despite increase in gain or change in the ultrasound wave's frequency.~      Many women elect breast augmentation for cosmetic reasons. Women with congenital heart~     disease who have undergone cardiac surgery may have breast asymmetry or distortion and desire~     augmentation accordingly.~      Knowledge of the extent of impairment of breast implants to the echocardiographic examination~     is important for few reasons:~        1. Women with heart disease who need echocardiographic follow up and wish to undergo breast~          augmentation should be consulted as to the limitation of the echocardiographic~          examination following the procedure.~        2. Women without heart disease considering breast augmentation should be informed of~          potential echocardiographic interference, if echocardiography be needed in the future,~        3. Different surgical techniques may cause different masking effect.~        4. Different implants size and shape may cause different masking effect.~   "
123921|NCT01945450|"~     Background: There is scarce evidence regarding the necessity of antibiotic prophylaxis in~     manual revision of the uterus after labor in cases of residual placenta.~      Methods: a randomized control trial in which parturients for which the placenta was not~     separated or there is a suspected residual placenta will be divided randomly to two groups:~     (1) Revision of uterus or Manual lysis without antibiotic prophylaxis; (2) Revision of uterus~     or Manual lysis with antibiotic prophylaxis as following: 24 hours coverage with Ampicillin 2~     grams*4, Gentamycin 240 mg*1, Clindamycin 600 mg*3. In cases of allergy to Penicillin the~     antibiotic regimen will be: Gentamycin 240 mg*1, Clindamycin 600 mg*3.~      Outcomes: Puerperal fever, endometritis, length of hospitalization after labor, recurrent~     hospitalization in the first 2 weeks after discharge.~   "
123922|NCT01945437|"~     The hypothesis of this study is that in staged bilateral total knee arthroplasty (TKA,~     magnesium sulfate administered during the perioperative period of the first TKA may decrease~     pain after the second TKA. It is known that pain is greater in the second TKA than in the~     first. Therefore, we compared pain of the second TKA between the magnesium and control~     groups.~   "
123923|NCT01945424|"~     The Sanofi Pasteur Quadrivalent Influenza Vaccine (QIV) Pregnancy Registry will be a~     prospectively recruited pregnancy surveillance program designed to collect and analyze~     information on vaccine exposures, pregnancy outcomes, and fetal and offspring outcomes.~   "
123924|NCT01945411|"~     The purpose of this study is to assess the facial measurements for determining the proper~     sizes of oropharyngeal airway. Investigators hypothesized that the length between incisors~     and mandible angle is more appropriate to estimate the size of oropharyngeal airway compared~     with the length between mouth corner and mandible angle.~   "
123925|NCT01945398|"~     This research intends to evaluate if inspiratory muscle training (IMT) reduces inspiratory~     muscle metaboreflex through the decrease of calf vascular resistance and increase of calf~     blood flow in Chronic Obstructive Pulmonary Disease (COPD).~   "
123926|NCT01945385|"~     Primary: To compare rates of immediate postabortal LARC uptake between women exposed to a~     brief, theory-based, video intervention prior to standard contraceptive counseling and women~     exposed to standard counseling alone.~      Secondary: To identify predictors of immediate postabortal LARC uptake among all participants~     including the role of:~        -  Demographic and reproductive health history variables~        -  Baseline decisional balance, self-efficacy and stage of change for contraceptive~          initiation~   "
123927|NCT01945372|"~     Premenstrual Dysphoric Disorder (PMDD) is characterized by affective instability and~     irritability, diagnosed in 5% of reproductive-age women. Although causing severe insult to~     patients' functioning and quality of life, ~40% do not respond to conventional treatment~     options.~      In this study, the investigators aim to examine a novel therapeutic approach for the~     treatment of affective instability in PMDD: brain-guided training (i.e.NeuroFeedBack, NF)~     probed by prefrontal EEG alpha asymmetry. PMDD patients will be randomly assigned to either a~     real or sham EEG-NF protocol, and undergo simultaneous fMRI-EEG scans before and after~     training period. Comprehensive psychological assessment will be performed for outcome~     measure. The investigators hypothesize that EEG-NF treatment will enhance affective~     stability, thus improving patients' daily lives.~   "
123928|NCT01945359|"~     This study will observe participants with relapsing remitting multiple sclerosis who are~     switching therapies from natalizumab to dimethyl fumarate to determine disease stability.~   "
123972|NCT01944787|"~     The hypothesis of the present study is the hydration of nulliparous women with 250ml/hour vs.~     125ml/hrs would decrease the rate of primary cesarean section.~   "
123932|NCT01945307|"~     We need human blood to understand the immune response to infection and to test promising new~     vaccines against infectious diseases in the laboratory. One test is called the Serum~     Bactericidal Assay (or SBA), which is measure of how effective antibodies are at killing~     certain bacteria and can be an important measure of how effective a new vaccine may be.~      The samples would be used in the laboratory analysis of clinical trials of vaccines used in~     adults and children, and some samples in pre-clinical (animal) experiments testing new~     vaccines before they enter human-stage testing. Most people have some form of protection~     against most bacteria already, so not everyone is a suitable blood donor for this laboratory~     test. We therefore start by taking a small blood sample and test this one before asking for~     more blood if we found yours suitable for the work we do.~   "
123933|NCT01945294|"~     The purpose of this study is to estimate the difference in the efficacy between a 16-week~     treatment regimen of boceprevir (BOC) in combination with peg-intron alpha 2b (P) plus~     ribavirin (R) (BOC + PR) and a 28-week treatment regimen of BOC + PR in previously untreated~     participants with chronic hepatitis C (CHC) genotype 1 in Asia who achieve undetectable~     hepatitis C virus ribonucleic acid (HCV RNA).~   "
123934|NCT01945281|"~     The study will evaluate the safety, tolerability, and efficacy of caspofungin as compared~     with amphotericin B deoxycholate in the treatment of invasive candidiasis in neonates and~     infants. The primary hypothesis to be tested in the study is that caspofungin will be~     superior to amphotericin B deoxycholate with regard to the proportion of participants with~     fungal-free survival at the 2-week posttherapy follow-up visit.~   "
123935|NCT01945268|"~     A multi-centre, randomized, placebo controlled, trial. Participants at high-risk for vascular~     events from the network of INTER- CHF will be randomized to inactivated influenza vaccine or~     placebo and followed prospectively over three influenza seasons. 600 participants will be~     enrolled prior to influenza season and randomized to either influenza vaccine or saline~     placebo.~   "
123936|NCT01945255|"~     Cardiovascular disease (CVD) is the leading cause of mortality in patients with end-stage~     renal disease (ESRD), which means that it is important to find out risk factors of CVD in~     order to prevent or treat it. In recent years, there has been more and more recognition of a~     very high prevalence of CV calcification in the ESRD population. Many observational cohort~     studies have shown that CV calcification in these patients can predict mortality, CV~     mortality and morbidity. Electrolyte imbalance is easily found in the ESRD patients which may~     result in vessel calcification. Calcification leads to arterial stenosis and increasing~     arterial stiffness and then heart afterload, both contribute to the development of CVD.~     Besides, metabolic syndrome, insulin resistance, and dyslipidemia pave the way for a chronic,~     immune-mediated vascular inflammation and cardiovascular disease. These factors are prevalent~     in ESRD patients, which would also cause arterial stiffness. Arterial stiffness and stenosis~     would increase the risk of CV events and mortality. Aortic pulse wave velocity is strongly~     associated with the presence and extent of atherosclerosis and constitutes a forceful marker~     and predictor of cardiovascular risk. At the same time, high prevalence of peripheral artery~     occlusion disease (PAOD) should also be found while arterial stiffness and stenosis, which~     would increase the condition of infection and gangrene. Thus, life safety and quality would~     be influenced severely and early detection might prevent future amputation. Uremic patients~     also have a higher risk for metabolic syndrome. Therefore, more studies to evaluate the~     condition of arterial stiffness and PAOD, especially in HD patients, are needed for future~     management and preventions of CV related morbidity and mortality.~   "
123937|NCT01945242|"~     The purpose of this study is to determine the safety and efficacy of long-term combination~     therapy with alogliptin (Nesina) and thiazolidinediones in patients with type 2 diabetes~     mellitus who failed to respond adequately to treatment with thiazolidinediones in addition to~     diet therapy and exercise therapy.~   "
123938|NCT01945229|"~     Background: Atrial fibrillation is a common heart rhythm disturbance affecting some 1-2% of~     the western population. It may cause symptoms such as irregular heartbeats, shortness of~     breath, and fatigue. It may also be asymptomatic (ie silent atrial fibrillation). In some~     cases, atrial fibrillation is permanent whereas in others it is sporadic. Regardless of~     symptoms, there is an increased risk of stroke in some patients with this condition. Novel~     technologies are being developed to increase detection of silent atrial fibrillation, in~     order to find patients who might benefit from treatment with oral anticoagulants~     (blood-thinning medications) in order to reduce the risk of stroke. One of these technologies~     is thumb-ECG, a simple way for a patient to have his or her heart rhythm reliably analyzed at~     home.~      Hyperthyroidism (sometimes referred to as toxic goiter) is defined as an excessive~     production of thyroid hormone. It is known that hyperthyroidism may cause atrial fibrillation~     in about 8% of cases.~      Objective: To provide thumb-ECG-monitors to hyperthyroid patients before and after treating~     their hormonal disturbance, in order to find episodes of silent atrial fibrillation.~      Design: Prospective observational study.~      Hypotheses:~        -  Primary hypothesis: Silent atrial fibrillation is at least as common as overt atrial~          fibrillation in hyperthyroid patients.~        -  Secondary hypothesis nr 1: Atrial fibrillation continues to be more prevalent compared~          to the normal population even after hyperthyroidism is treated.~        -  Secondary hypothesis nr 2: The majority of patients with hyperthyroidism and atrial~          fibrillation are at increased risk of stroke and should be considered for treatment with~          oral anticoagulants.~   "
123939|NCT01945216|"~     The purpose of this study is to determine the safety and efficacy of long-term treatment with~     alogliptin (Nesina) in patients with type 2 diabetes mellitus who responded inadequately to~     diet therapy and exercise therapy alone, or a combination of diet therapy, exercise therapy,~     and α-glucosidase inhibitor.~      In addition, examining the safety and efficacy of alogliptin in patients with renal~     impairment, information on the appropriate dosage of alogliptin according to the severity of~     impaired renal function should be collected.~   "
123973|NCT01944774|"~     The purpose of this study is to Evaluate the Efficacy, safety and pharmacokinetics of~     Intravenous Nemonoxacin Compared with Intravenous Moxifloxacin in Adult Patients with~     community-acquired pneumonia (CAP).~   "
123974|NCT01944761|"~     The objectives of our proposed study are to (a) evaluate the feasibility of conducting a~     structured exercise program in children treated with cranial radiation for brain tumors, (b)~     test whether exercise results in improved thinking skills and emotional function, and (c)~     examine potential mechanisms of improved outcome, particularly recovery of white matter and~     grey matter.~   "
123940|NCT01945203|"~     Cardiovascular disease (CVD) is the leading cause of mortality in patients with end-stage~     renal disease (ESRD), which means that it is important to find out risk factors of CVD in~     order to prevent or treat it. In recent years, there has been more and more recognition of a~     very high prevalence of CV calcification in the ESRD population. Many observational cohort~     studies have shown that CV calcification in these patients can predict mortality, CV~     mortality and morbidity. Electrolyte imbalance is easily found in the ESRD patients which may~     result in vessel calcification. Calcification leads to arterial stenosis and increasing~     arterial stiffness and then heart afterload, both contribute to the development of CVD.~     Besides, metabolic syndrome, insulin resistance, and dyslipidemia pave the way for a chronic,~     immune-mediated vascular inflammation and cardiovascular disease. These factors are prevalent~     in ESRD patients, which would also cause arterial stiffness. Arterial stiffness and stenosis~     would increase the risk of CV events and mortality. Aortic pulse wave velocity is strongly~     associated with the presence and extent of atherosclerosis and constitutes a forceful marker~     and predictor of cardiovascular risk. At the same time, high prevalence of peripheral artery~     occlusion disease (PAOD) should also be found while arterial stiffness and stenosis, which~     would increase the condition of infection and gangrene. Thus, life safety and quality would~     be influenced severely and early detection might prevent future amputation. As compared with~     HD or pre-dialysis patients, uremic patients treated with PD have a higher risk for metabolic~     syndrome. Therefore, more studies to evaluate the condition of arterial stiffness and PAOD,~     especially in PD patients, are needed for future management and preventions of CV related~     morbidity and mortality.~   "
123941|NCT01945190|"~     Acupuncture is used extensively by patients worldwide for a variety of illnesses. While~     research is beginning to show effectiveness in clinical pain, the mechanisms underlying how~     these effects are evoked are poorly understood. Experimental models in healthy human~     volunteers can more closely control the variables of acupuncture needling and begin to~     separate out the relative contribution of specific components of needling and needle~     stimulation. By examining acupuncture's effects on experimental inflammatory models with~     well-characterized physiologic mechanisms, hypotheses can begin to be generated regarding how~     acupuncture produces its clinical effects. We propose to establish a model which could be~     used as a template to examine the individual components contributing to acupuncture's~     clinical effects on inflammation and pain. We hypothesize that acupuncture will have~     analgesic and anti-inflammatory effects on a ultraviolet B induced cutaneous lesion as well~     as a model of heat pain testing which activates central sensitization.~      Twenty healthy human volunteers will participate in a crossover study with active acupuncture~     and sham acupuncture interventions. They will be tested for their minimal erythemal dose~     (MED) to ultraviolet B exposure. An experimental lesion at 3x MED will be administered on the~     lower leg. Background information will be collected which could affect individuals'~     sensitivity to pain such as anxiety and depression, as well as their expectations regarding~     acupuncture treatment.~      The following day they will return for the first experimental day. A measurement with Laser~     Doppler will quantify the inflammation in the ultraviolet B lesion. Heat pain testing will be~     performed using a computer controlled thermode both on and off the ultraviolet B lesion.~     On-lesion testing will be for heat pain threshold. Off-lesion testing will examine temporal~     summation of heat pain.~      Next, a licensed acupuncturist will perform either true electroacupuncture or sham~     electroacupuncture in the region adjacent to the ultraviolet B lesion. Participants are~     blinded to the intervention, as is the examiner collecting data. Afterwards, Laser Doppler~     and heat pain testing will be repeated. The difference between pre-acupuncture and~     post-acupuncture measurements will represent the acupuncture -induced analgesic and~     anti-inflammatory effects.~      Participants will return for another ultraviolet B exposure adjacent to the first, and will~     receive whichever sham or true acupuncture intervention was not performed on the first study~     day.~   "
123942|NCT01945177|"~     It is recognized that gastroscopy can miss intestinal metaplasia, dysplasia and early gastric~     cancer. This could conceivably be due to the fact that these lesions may only present as~     subtle mucosal changes on conventional white light endoscopy (WLE) and thus be easily missed.~     In narrow band imaging (NBI) a rotating interference narrow band filter is interposed after~     the xenon light source such that when the NBI mode is switched on, discrete blue and green~     wavelengths are used and this improves mucosal surface contrast and facilitates visualization~     of mucosal details. A new NBI system is available that allows brighter illumination. We~     hypothesize that bright -NBI is superior to WLE in detecting focal gastric lesions such as~     gastric intestinal metaplasia, dysplasia and early gastric cancer in subjects undergoing~     gastroscopy.~   "
123943|NCT01945164|"~     Cancer is a worldwide clinical and economic problem. Conventional approaches to treating~     cancer include surgery, radiotherapy, and cytotoxic chemotherapy as single modalities or as~     combined therapies. Recently, targeted therapies including antibodies and small molecule~     inhibitors have also demonstrated clinical benefit. It is now possible to study different~     genetic lesions involved in cancer types due to advances in genomic methodologies. The~     investigational drug in this study, XL999 inhibits multiple receptor tyrosine kinases,~     including VEGF receptor (VEGFR2/KDR), platelet derived growth factor receptors (PDGFRβ),~     fms-like tyrosine kinase receptor 3 (FLT3), fibroblast growth factor receptors (FGFR1,~     FGFR3), RET, and KIT, and thus, interferes with multiple cellular processes simultaneously~     and will likely have effects on the integrity of tumor neovasculature and angiogenesis.~     Together with the ability to induce a novel cell cycle arrest, the spectrum of activities~     that XL999 exhibits may reduce both tumor cell proliferation and angiogenesis in the clinic.~      The rationale and purpose of this maintenance study is to allow a subject receiving clinical~     benefit from XL999 to continue treatment.~   "
123944|NCT01945151|"~     To evaluate and compare the effects of Neuromuscular Electrical Stimulation when applied in~     the agonist and antagonist muscles of spastic hemiparetic patients.~      The specific objectives are:~        -  Evaluate the resistance movement, strength and muscle electrical activity before and~          after application of Neuromuscular Electrical Stimulation in spastic muscle~          (gastrocnemius).~        -  Evaluate the resistance movement, strength and muscle electrical activity before and~          after application of Neuromuscular Electrical Stimulation in the spastic antagonist~          muscle (tibialis anterior).~        -  Compare the risk of falls after application of Neuromuscular Electrical Stimulation in~          both muscles studied.~   "
123945|NCT01945138|"~     The purpose of this study is to determine the effectiveness of closed loop insulin pump~     therapy to control blood sugar following total pancreatectomy and islet auto-transplantation~     (TPIAT).~   "
123946|NCT01945125|"~     To observe the influence of thyroid hormone withdrawal and of recombinant human TSH during~     radioiodine therapy in renal function.~   "
123947|NCT01945112|"~     Friction foot blisters are one of the most common and often debilitating complaints of all~     athletes, and hikers and runners in particular. Blistering rates in the literature of outdoor~     hikers range from 7%-54%. This study's aim is to build on Pre-TAPED I, and determine whether~     applying paper tape to the areas of the foot where blisters historically occur in endurance~     runners can prevent the incidence of friction blisters.~   "
124213|NCT01941654|"~     To determine the efficacy of preemptive local ablative therapy in NSCLC patients with~     activating EGFR mutation who have oligometastatic residual metabolic-active disease after~     first-line EGFR TKI, as measured by PFS rate at 1 year from the trial enrollment.~   "
123950|NCT01945073|"~     Increased knowledge about an illness can increase self-management among those afflicted. In~     order to facilitate people with sickle cell disease living a longer and healthier life, they~     should be taught to manage their illness.An adolescent with a chronic illness has many unique~     challenges, in addition to maneuvering the turbulent adolescence period itself. It has been~     that better knowledge and more positive perceptions of their illness equate not only to~     better control of their illness but also better quality of life.Studies have also shown the~     benefits of self-management: when patients are responsible for managing their own illness,~     their clinical outcomes and quality of life improve and they become less dependent on health~     care services.~      In this study we aim to examine if knowledge, and any changes in knowledge, will each have~     any association with Quality of Life (QOL) and their perceptions of their illness (IP). We~     also seek to investigate the effects of an educational booklet, as well as an intervention~     including the educational booklet with formal counselling on their knowledge, QOL and IPs.~   "
123951|NCT01945060|"~     The purpose of this study is to see if the Artificial Pancreas (AP) Platform can successfully~     control blood sugar in people with type 1 diabetes mellitus on insulin pump therapy in a~     hospital setting. Investigators will also be studying to see if the heart rate informed~     Control To Range (hrCTR) can improve the performance of the system during and immediately~     after exercise.~   "
123952|NCT01945047|"~     Depression carries the largest burden of all medical disorders in middle to high income~     countries, as determined by the World Health Organization. Despite many antidepressant~     strategies, only a third of patients get well after their first treatment and a third remain~     ill after several treatments. Moreover, antidepressant treatments all have a delayed action~     ranging up to several weeks.~      Ketamine (KET) has been used for decades as a sedative and anesthetic. In treatment-resistant~     depressed patients(TRD), an intravenous dose much lower than necessary for anesthesia may~     produce a robust antidepressant effect and may even abolish suicidal thoughts within hours,~     peaking within 24 hours. But, its antidepressant effect generally lasts only days.Previous~     studies examining KET in TRD have been critiqued for lack of an effective placebo measure due~     to brief perceptual experiences associated with KET. Thus, the current study compares KET~     against a short-acting sedative. The phases of this study compare response to a single KET~     injection to 6 injections over 2 weeks. Next, KET responders are given 1 injection a week for~     3 weeks of either KET or the sedative agent to determine if beneficial effects of KET are~     maintained, and to assess duration of its benefits after repeated administration. The genetic~     profile of patients for a substance promoting contacts between cells and brain will be~     determined to investigate if response to KET could be predicted with that blood test. This~     substance, as well as several chemicals that produce inflammation, will also be measured in~     the blood to investigate their role in the effect of KET. Patients will receive, in total, no~     more than the equivalent of two to three anesthetic dose of KET. Results from this study will~     help establish the beneficial effects of a single KET injection as a rapid intervention for~     major depression, and to investigate the possibility of obtaining a prolonged antidepressant~     effect with repeated injections.~   "
123953|NCT01945034|"~     This study is being conducted to evaluate the effects of IBU 5% Topical Gel versus topical~     placebo for the relief of pain associated with a first or second degree ankle sprain. Both~     twice daily and three times daily regimens will be evaluated.~   "
123954|NCT01945021|"~     To assess treatment effectiveness and safety of oral crizotinib administered to East Asian~     patients with Advanced Non-Small Cell Lung Cancer (NSCLC) that is confirmed to be positive~     for a ROS1 positive gene mutation (translocation or inversion) and confirmed negative for an~     ALK mutation~   "
123955|NCT01945008|"~     HCV infection is the most frequent cause of liver chronic disease, cirrhosis and~     hepatocellular carcinoma in western countries.~      To date, the standard antiviral treatment, including pegylated interferon (PEG-IFN) plus~     ribavirin (RBV), has relatively low effectiveness in patients infected with genotype 1 and 4,~     and is associated with important adverse side effects, that lead to treatment interruption in~     approximately 30% of cases.~      The recent association of first generation HCV- specific direct-acting antiviral agents~     (DAAs) (telaprevir and boceprevir) to standard treatment has resulted in higher SVR rates,~     also in patients infected with genotype-1 HCV and in non responders to PEG-IFN plus RBV.~     While several new DAAs are in development, the ultimate goal is represented by IFN-free~     regimens, that will provide a great advantage in terms of patients adherence to therapy and~     quality of life.~      In this context, prospective observational studies are needed to evaluate the real and~     long-term impact of the new DAAs in the clinical practice, in terms of efficacy, safety,~     costs and impact on patients quality of life.~      The Italian context~      Italy is the European country with the greatest number of HCV infected people (average, 3% of~     population), with higher prevalence in the center and in the south of the country, especially~     in older individuals, and the highest mortality caused by hepatocellular carcinoma. Genotype~     1 is the most frequent one (in more than 50% of infected people). DAAs were approved at the~     end of 2012. For these reasons, Italy represents an interesting context for collecting data~     on long-term efficacy, safety and tolerability of new anti-HCV treatments.~      The PITER cohort study, developed in the frame of Italian Platform for the study of the~     therapy of viral hepatitis a prospective observational study, is based on a large cohort of~     HCV infected patients from more than 100 clinical centers distributed on the whole national~     area (we can provide a list on demand).~      The PITER cohort study will provide exhaustive information on:~        -  Clinical and virologic natural history of all enrolled patients~        -  Therapeutic outcomes in different clinical/virologic contexts and in special populations~          starting a new treatment (i.e. Predictors of virological response, disease progression~          or fibrosis regression~        -  quality of life of patients~        -  pharmacokinetics of drugs and pharmacological interactions~        -  Short, middle and long term side effects~        -  Minimum duration of therapy to reach the sustained virological response~        -  Aspects related to personalization of treatment in specific populations: old people,~          women, immigrants or marginalized populations, patients not responding to standardized~          treatment protocols, patients waiting for liver transplantation or transplanted patients~        -  Role of viral variability in the natural history of the disease and in the response to~          treatment~        -  Pharmacoeconomics and risk-benefits analysis. All these information will be used to~          evaluate prescription appropriateness in Italy, with important implications for public~          health..~      PITER may also represent a starting point and a base for future clinical studies,~     contributing to the optimization of therapeutic protocols and to the formulation of~     guidelines on the use of new therapies for HCV treatment~   "
123956|NCT01944995|"~     Nasal continuous positive airway pressure (nCPAP), widely used in neonatal intensive care is~     also more and more used in infants with severe acute bronchiolitis. There is no evidence that~     nCPAP improves outcome, but several studies showed that it reduces work of breathing (WOB),~     improves gas exchange and decreases intubation rate. High flow nasal prong (HFNP) therapy,~     also used in neonatal units, has recently been suggested for bronchiolitis management. This~     technique allows warmed and moist gas administration protecting nasal mucosa, and preventing~     variations of inspired gas FiO2. HFNP also creates a continuous positive pressure, reducing~     WOB, and seems much more comfortable and better tolerated by babies than nCPAP. There are no~     studies comparing both techniques for bronchiolitis management. The main objective of this~     study is to compare WOB with nCPAP and HFNP therapy in infants with severe bronchiolitis in~     pediatric intensive care unit. Secondary purpose is to compare efficacy and tolerance of both~     techniques. We propose to lead an open, single center, crossover randomized study. Each~     patient will receive the two treatments. Three consecutive periods will be studied: first one~     (minimum 2 hours), with the first technique CPAP or HFNP according to randomization~     (treatment 1); second period (2 hours) with the second technique (treatment 2); Third period~     (6 hours) with the second technique. The primary endpoint will be the comparison of WOB~     (estimated by the calculation of the transdiaphragmatic pressure-time product) at the end of~     the two firsts periods. Efficacy and tolerance of each technique will be evaluated and~     compared by compared measuring respiratory rate, heart rate, FiO2, SpO2, transcutaneous PCO2,~     modified Wood score, and EDIN score during the third period. Nine subjects by groups are~     required.~   "
123957|NCT01944982|"~     To determine safety profile of immunotherapy with natural killer cells and activated expanded~     (NKAEs) after salvage chemotherapy in relapsed/refractory paediatric T cell lymphoblastic~     leukaemia and lymphoma.~   "
123958|NCT01944969|"~     To evaluate the long-term safety and tolerability of brexpiprazole as adjunctive treatment in~     patients with Major Depressive Disorder (MDD)~   "
123959|NCT01944956|"~     Our objective was to evaluate maturation of sucking and swallowing in preterm infants using a~     non-invasive method: assessment of swallowing sounds. Findings in healthy term infants were~     used as reference values.~   "
123960|NCT01944943|"~     The purpose of this study is to determine the efficacy of Vismodegib drug in treatment of~     patients with relapsed or refractory B-cell lymphoma or chronic lymphocytic leukemia (CLL).~   "
123975|NCT01944748|"~     The goal of this project is to conduct a pilot evaluation of a parent-child mediation program~     for at-risk youth. It is investigating whether families who receive parent-child mediation~     show greater improvement in family functioning, as well as adolescent substance use, academic~     performance, and delinquency, over a 6-week and 12-week period compared to a wait-list~     control sample.~   "
123976|NCT01944735|"~     The purpose of this study is to assess the safety and tolerability of multiple oral doses of~     CTX-4430 when administered to cystic fibrosis (CF) patients once-daily (QD) for 15 days.This~     study will include two dose levels. For each dose level, blood samples will be collected for~     exploratory PK and PD assay validation. In addition, sputum will be collected for exploratory~     biomarker analysis. Following multiple dose administration, pulmonary function and~     exploratory lung clearance index (LCI) measurements will be taken.~   "
123961|NCT01944930|"~     Adult patients evaluated at Lahey Clinic with known or suspected gastrointestinal or~     gynecologic malignancies and with an indication for diagnostic laparoscopy will be offered~     participation in the study. The proposed study is a randomized, controlled feasibility trial~     with crossover design. The study's aim is to evaluate the effectiveness of laparoscopic~     narrow band imaging (NBI) compared to standard white-light laparoscopy for detection of~     peritoneal cancer metastases. Study patients will undergo laparoscopic evaluation of the~     peritoneal cavity using a routine white-light videolaparoscope with the capability of NBI.~     The order of white-light and NBI laparoscopy will be randomized for each patient (crossover~     design). Frozen-section histopathology biopsies will be retrieved of all suspicious-appearing~     abnormalities using best clinical practices. The number of detected peritoneal metastases~     will be compared between each diagnostic laparoscopy technique. To gauge the rate of~     potentially missed metastases, peritoneal cancer recurrence will be surveyed through a 1-year~     follow-up.~   "
123962|NCT01944917|"~     Previously it has been demonstrated that exposing the heart to electromagnetic field during~     exercise stress test improves the recovery following the stress test. This is explained by~     the effect of the electromagnetic field on the sympathetic activity of the heart. In the~     present study we would like to further investigate the effects of electromagnetic field on~     autonomic nervous system function in patients with chronic musculoskeletal pain that usually~     have high sympathetic activity. Each patient will be exposed to 20 minutes of electromagnetic~     field during which the autonomic nervous system function will be measured. In addition,~     patient tolerability to the exposed magnetic field will be investigated. We assume that short~     exposure to electromagnetic field would result in decreased sympathetic activity and~     therefore, on the long run, could be suggested as a therapeutic tool for such patients.~   "
123963|NCT01944904|"~     This study aims to determine whether the use of a supplement called xylooligosaccharide (XOS)~     increases the number of good bacteria that live in human intestines and can maintain healthy~     blood sugar levels, and whether XOS has any unpleasant or unexpected side effects when~     consumed at different dosages. Subjects who participate in this study will be randomized to~     receive an eight week supply of either a lower dose of XOS or placebo (no active substance).~     This will be determined randomly, in a process similar to flipping a coin. Blood samples will~     be taken at each visits, including an oral glucose tolerance test. Subjects will also be~     asked to collect and bring in stool samples at three different time points during the study.~      Subjects will have a 50/50 chance of being assigned to the either study group. This is a~     double-blind study which means neither the study investigator nor the subject will know to~     which group he/she has been assigned. In case of an emergency, the study doctor can get this~     information.~   "
123964|NCT01944891|"~     Data on the diet and nutritional status of adolescent girls in Zambézia Province, Mozambique~     was collected. A cross-sectional study was carried out in 2010 in two seasons,~     January-February and May-June. Participants (total n=551) were recruited from Quelimane (the~     provincial capital), Maganja da Costa district and Morrumbala district.~   "
123965|NCT01944878|"~     The aim of this study is to assess the role of portal hypertension of peptic ulcer disease in~     liver cirrhosis and chronic hepatitis.~   "
123966|NCT01944865|"~     The aerobic fitness is important for mountain bikers, but riders should also be able to~     generate maximal and supramaximal efforts in some crucial phases of the competition. Although~     there is an increase interest in high-intensity aerobic training, to investigators knowledge,~     there are no studies examining the effects of interval (INTV) or intermittent training (INTM)~     in mountain bikers. The aim of this study was to compare the effects of INTV and INTM on~     aerobic fitness variables (peak power output, Wmax, lactate threshold, and onset of blood~     lactate accumulation) but more importantly on performance as measured using a controlled~     mountain bike race, i.e. simulation. The investigators hypothesized that INTV and INTM~     training were equally effective in improving Wmax, Lactate threshold and onset of blood~     lactate accumulation, but INTV was superior in enhancing performance in mountai bike race~     simulation.This hypothesis is due to studies that have shown higher gains in performance with~     long duration of aerobic high intensity interval training in comparison to the shorter~     training at a higher intensity.~   "
123967|NCT01944852|"~     The DIDo study is an open-label, randomised, multicentre study with 2 parallel groups in~     incident CAPD patients aged of 65 at minimum :~        -  One group in which patients will receive 2 bags of icodextrin/day and 1 bag of glucose~        -  One group in which patients will receive 1 bag of icodextrin/day and 2 bags of glucose.~   "
123968|NCT01944839|"~     The objectives of this study are to evaluate the safety and efficacy of intravitreal~     administration of Fovista® administered in combination with Lucentis® compared to Lucentis®~     monotherapy in subjects with subfoveal choroidal neovascularization secondary to age-related~     macular degeneration (AMD).~   "
123969|NCT01944826|"~     Prospective, multicenter, observational registry collecting data from subjects with~     Tako-Tsubo (stress-induced) cardiomyopathy (TTC). Uniform, complete, and accurate data will~     be collected on the subject's medical history, during index hospitalization for TTC, and~     during follow-up.~      The objectives are to evaluate the prevalence and incidence of cancer in patients with TTC,~     to document the underlying causes of death during hospital stay and during follow-up, to~     determine the long-term prognosis, and to identify possible predictors of short and long-term~     mortality.~   "
123970|NCT01944813|"~     Communication about end-of-life issues is often suboptimal. A way to improve the quality of~     end-of-life care is Advance Care Planning (ACP). ACP is a discussion between an incurable ill~     patient and the health professionals about preferences for end-of-life care. In Denmark,~     there is no tradition of systematic communication with patients about end-of-life care. The~     aim is to investigate how ACP can be beneficial among incurable ill patients treated in an~     outpatient context and if the concept is feasible in a Danish context. The study is designed~     as a prospective randomised controlled trial. Patients from relevant departments will be~     included and randomised in two groups: one receiving usual care and the other receiving usual~     care and ACP. Data will be collected from Electronic Patient Files and from questionnaires.~     If ACP is effective, it will improve the quality of end-of-life care for patients and their~     families and reduce the psychological distress in the bereaved relatives.~   "
123971|NCT01944800|"~     Aim of the randomized, open-label, multicenter ISAR-REACT 5 trial is to assess whether~     ticagrelor is superior to prasugrel in patients with acute coronary syndrome and planned~     invasive strategy in terms of clinical outcomes.~   "
123978|NCT01944709|"~     The prognosis of patients with metastatic melanoma is poor and current available treatments~     are limited. Identification of a number of melanoma-specific tumor antigens that are shared~     by tumors from different patients, provides attractive targets for immune-based therapies~     (http://www.bioinfo.org.cn/hptaa/). Different approaches like DNA-/RNA-vaccines, peptide~     vaccines and dendritic cell (DC) vaccines are under investigation to induce peptide-specific~     immune responses. In various animal models and in clinical trials it was shown that the most~     potent induction of anti tumor-specific killer cells was achieved with DC vaccination. DCs~     are professional antigen presenting cells (APC) that are critical in the initiation of~     cellular responses in naïve T lymphocytes, in vivo. They are armed with all the molecules~     needed for the induction of immune responses and have the capacity to migrate into secondary~     lymphatic organs. In vitro generated dendritic cells are loaded with tumor derived peptides~     and injected subcutaneously. The concept is to induce or to propagate already existing tumor~     specific killer T cells.~   "
123979|NCT01944696|"~     Cycled (intermittent) phototherapy will be compared to continuous (uninterrupted)~     phototherapy in the treatment of hyperbilirubinemia (newborn jaundice) in extremely low birth~     weight newborns in a pilot randomized controlled trial.~      Hypothesis: Cycled phototherapy (PT) will provide the same benefits as continuous~     phototherapy in extremely low birth weight (ELBW) infants without the risks that have been~     associated with continuous phototherapy.~   "
123980|NCT01944683|"~     The study will examine midazolam pharmacokinetics following single dose administration of 3~     planned dose levels of GGF2 .~   "
123981|NCT01944670|"~     The purpose of this study is to confirm the safety and effectiveness of the Internal Joint~     Stabilizer - Elbow.~   "
123982|NCT01944657|"~     A. Introduction to the Problem~      This field experiment is intended to explore whether supplemental transcranial magnetic~     stimulation (TMS) is more effective than standard medication mono-therapy for the treatment~     of major depressive disorder. Transcranial magnetic stimulation (TMS) is now included in the~     practice guidelines of the American Psychiatric Association for the treatment of major~     depression.~      B. Importance of the Area of Study~      The safety, efficacy and value of TMS treatment has been established through the four-phase~     FDA approval process. The evidence of TMS safety and efficacy derives from multiple, peer~     reviewed, double-blind, randomized, control trials (RCT) with sham control as well as strict~     enrollment and methodological requirements. TMS is now used in actual clinical practice and~     there is an opportunity to extend laboratory research and typical, highly controlled field~     settings to applied settings. This study is designed to gather data on safety, efficacy and~     utility of TMS as it is used in clinical practice.~      C. Need for Additional Research~      Efficacy and safety of these interventions have been scientifically established and~     meta-analyses of these studies underscore the efficacy and safety of two treatment~     interventions to be employed in this study: 1) standard medication monotherapy and 2)~     standard medication therapy supplemented with TMS. However, many authors conclude that~     depression can be difficult to treat and there is an ongoing need for additional research.~     Depression remains a major public health problem.~   "
123983|NCT01944644|"~     This is a double-blind, randomized, sham-controlled phase II study of the effects of Low~     Field Magnetic Stimulation (LFMS) on brain circuitry of adults with treatment-resistant Major~     Depressive Disorder (MDD). Eligible subjects will be randomly assigned to double-blind~     treatment with three 20 minute sessions of either (1) active LFMS or (2) sham LFMS. Resting~     state fMRI will be performed at baseline and following the third and final treatment session.~   "
123984|NCT01944631|"~     The aim of this clinical trial is to investigate the effect of Iota-Carrageenan treatment on~     cold symptoms. The effect of treatment on the duration of the cold and the patients viral~     load plus cytokine level indicating the inflammatory response will be analyzed.~   "
123985|NCT01944618|"~     The study purpose is to assess adverse events in patients with Type 2 diabetes who have newly~     been prescribed Forxiga for the management of glycemic control~   "
123986|NCT01944605|"~     Out-of-hospital cardiac arrest (CA) is a leading public health problem causing nearly one~     third of a million deaths annually in the US, accounting for half of all cardiovascular~     deaths and surpassing deaths from stroke, heart failure, and breast and lung cancer combined.~     Twenty to fifty percent of CA patients (pts) can be resuscitated initially but many die~     before hospital discharge or suffer permanent neurologic damage. Therapeutic hypothermia (TH)~     improves survival and neurological outcomes. Despite aggressive, targeted post arrest~     management, including TH, approximately 50% of pts die before leaving the hospital due to~     global ischemia-reperfusion injury (IRI) known as the post arrest syndrome, 1 which is a~     sepsis-like state characterized by elevated markers of cellular inflammation and injury. It~     is believed that TH works by decreasing the body's basal metabolic rate (BMR) and attenuating~     the systemic inflammatory response (SIR). However, specific triggers of the intense~     pro-inflammatory response are unclear. This gap in knowledge must be closed to identify~     targeted therapy to decrease IRI and improve outcomes.~      Blood flow to the gut is decreased markedly and intestinal tissue becomes ischemic during CA~     and CPR, particularly when vasoconstrictor drugs such as epinephrine, are given. IRI of the~     intestine increases intestinal permeability leading to intestinal microbial translocation and~     endotoxin release that can stimulate and perpetuate systemic inflammation and cause~     subsequent multi-organ dysfunction. Endotoxin also increases body temperature and energy~     expenditure and may attenuate TH induced reductions in BMR and hence, decrease efficacy. The~     purpose of this novel pilot study is to detect systemic endotoxin release following CA in~     humans and determine association with cytokine activation, and BMR alterations during TH.~   "
123987|NCT01944592|"~     Physical examination of the pelvis is an important core skill that medical students need to~     acquire. However, due to its intimate nature some students are graduating unable to perform~     competent pelvic examinations. Gynaecological Teaching Associates (GTA's) are women who have~     been trained to be examined and give valuable feedback to the students. In North America~     GTA's are quite commonly used in the medical curriculum and they have also been used in~     Canada, Australia and Scandinavia. In the UK pelvic examination is mainly taught using a~     combination of clinic patients, pelvic models and patients anaesthetised for surgery. In~     Birmingham we have already started using GTA's and like other Universities such as Oxford the~     students have given positive feedback.~      GTA's are paid professionals and hence introducing this method of teaching has financial~     implications for Universities. Unless it is proven to be worthwhile it is unlikely that~     academic institutions will introduce and maintain GTA programs. One UK study did show that~     those who had been trained with a GTA's and pelvic models were significantly better than~     those who had been trained with pelvic models alone. However, in this study the GTA training~     was supplementary to the normal curriculum so the amount of teaching rather than the style of~     teaching may have acted as a confounding factor. Therefore, a large randomised trial of~     trainees on the Obstetrics and Gynaecology (O&G) programme comparing those given an initial~     teaching session on a pelvic model and those taught by GTA's is needed to assess the~     effectiveness of GTA's on confidence and competence of the students by the end of the~     training programme is needed.~   "
123988|NCT01944579|"~     Intestinal bacteria can metabolize unabsorbed polyphenols (plant compounds) to produce~     smaller molecules which may impact health. In addition, evidence suggests that this process~     may be affected by body fatness. This study aims to investigate absorption of blackberry~     polyphenols, their impact on intestinal bacteria, polyphenol metabolites formed by intestinal~     bacteria, and how these processes differ for obese and lean individuals. It is hypothesized~     that polyphenol absorption and metabolism will differ between obese and lean individuals and~     that differences in intestinal microbiota may play a role.~   "
124214|NCT01941641|"~     Objective tumour response rate to FOLFOXIRI to pre-operative therapy.~   "
128768|NCT01881932|"~     In this study the investigators will assess how useful and safe acupuncture is in easing the~     pain, tingling and numbness that is caused by chemotherapy. The researchers hope this will~     prevent the need to reduce the amount of chemotherapy a patient receives.~   "
123989|NCT01944566|"~     The malodour generation of a person's armpit is caused by the bacteria thriving on that~     armpit. In order to alter or reduce once bad body odour, the living microbial community on~     the armpit of a non-malodorous person will be transmitted (or up scaled and transmitted) to~     the armpit of a malodorous person. The odour is evaluated by a trained smelling panel, the~     bacteria living on the armpit is examined by means of molecular techniques. The microbial~     transplantation and its follow-up happens under the supervision of a medical doctor.~   "
123990|NCT01944553|"~     The main objective of the study is to evaluate the feasibility of using the robotic assisted~     device ROSA™ for pedicle screws placement. This device is currently used in cranial~     neurosurgery but its applications can be extended to other fields, such as spinal surgery. In~     the future, the use of ROSA™ in pedicle screw placement could increase the accuracy and~     safety of surgery for the patient.~   "
123991|NCT01944540|"~     This study is aimed to analyze the outcomes after conventional endoscopic submucosal~     dissection (ESD) and optimized ESD with snaring (oESD-S) for colorectal neoplasm that is more~     than 20 mm in diameter of laterllay spreading tumor or flat elevated lesion without stalk.~      Optimized ESD with snaring means submucosal dissection followed by snaring when narrowed~     circumference of the remained submucosal tissue beneath the lesion is less than 5 mm in~     diameter with snaring, then resected by using an electric current.~      The investigators expect optimized ESD with snaring can provide more time-saving procedure~     with comparable en-bloc resection rate and perforation rate, when compared with the~     conventional ESD method.~   "
123992|NCT01944527|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of~     direct-acting antivirals therapy in liver transplanted patients who experienced HCV~     recurrence.~      This cohort is multicentric with constitution of biobank (plasma, serum) and the prospective~     collect of biological and clinical data's in the liver transplanted patients with recurrent~     HCV infection and treated with direct-acting anti-HCV agents.~   "
123993|NCT01944514|"~     Worldwide three million people a year die from sudden cardiac death (SCD). In most cases~     there is no warning and the heart is stopped by a sudden arrhythmia. We know that some people~     are at high risk of sudden cardiac death and can prevent their deaths with an implantable~     cardioverter defibrillator (ICD) that is implanted in a minor operation.~      However, most people who die from sudden cardiac death are not found to be at high risk by~     our current risk markers and 40% of the people who have ICDs do not have therapy within the~     first 4 years after implant. We need new and better ways of identifying people who are at~     high risk of sudden cardiac death so that we can prevent their deaths with ICDs. Our~     understanding of the electrical signals in the heart has increased considerably in recent~     years; in no small part this is due to our Principal Investigator Professor Andre Ng's basic~     science work. This study aims to take the understanding of action potential duration (APD)~     restitution gained through our work and other studies in humans and in computer simulations~     and translate it into a fresh way of assessing risk of sudden cardiac death.~      This study will carefully examine electrical activity, using APD restitution, in the hearts~     of patients who are having ICDs fitted because of their high risk of sudden cardiac death and~     combine this with a detailed heart scan, assessment of autonomic nervous system and gene~     expression data. We will then follow these patients up to see who benefits from their ICD.~     This wide ranging information will give us as complete a picture as possible of the factors~     that cause sudden cardiac death. We hope to use this to identify better predictors of sudden~     cardiac death.~      The study hypotheses are as follows:~      Primary~        1. Regional Restitution Instability Index (R2I2) will be significantly higher in patients~          reaching the endpoint of ventricular endpoint / sudden cardiac death than in those not.~        2. An R2I2 cut-off of 1.03 will partition patients into high and low risk groups.~           Secondary~        3. Peri-infarct zone mass in grams will be significantly higher in patients reaching the~          endpoint of ventricular endpoint / sudden cardiac death than in those not.~   "
123994|NCT01944501|"~     This study aimed at trying transcranial magnetic stimulation and transcranial direct current~     stimulation as potential treatments to decrease tinnitus in patients with significant hearing~     loss.~   "
123995|NCT01944488|"~     The project aims to establish the normal LH and FSH response to a standardized GnRH dose in~     healthy girls below 6 years of age, and compares the normal GnRH response to the GnRH~     response in girls with early puberty development.~      The novel data may help to determine whether the girl is in early puberty or not.~      Healthy girls under 6 years of age attending routine examinations including an i.v. line for~     other causes are included in this study. Our examinations also include bone age~     determination, Tanner stage determination, and anthropometric measures (height and weight).~     10 healthy girls in each of the following age groups: 7-12 months, 12-24 months, 24-36~     months, 36-48 months, 48-60 months and 60-72 months are included.~   "
123996|NCT01944475|"~     Precocious puberty - the onset of signs of puberty before 8 years of age in girls - is be~     physically and emotionally devastating for kids and is sometimes caused by an underlying and~     medical condition. One sign of precocious puberty in small girls is breast development~     (thelarche). This can persist without other physical changes of puberty, it may continue into~     precocious puberty, or it may disappear. This project will improve the diagnostics of~     precocious puberty in girls and improve our ability to identify which girls with thelarche,~     who will develop precocious puberty and need medical treatment.~   "
123997|NCT01944462|"~     The overall goals of this program are to measure the impact of a pharmacist pneumococcal~     vaccine education program (PPVP) using a senior center model of care and provide the~     pneumococcal vaccine to eligible participants.~      Hypotheses~        1. PPVP will result in improved knowledge and awareness in older minorities in the senior~          center setting (primary hypothesis);~        2. Participants who are vaccinated through the project will experienced increased trust in~          receiving vaccines from a pharmacist;~        3. Participants will be satisfied with and trust the PV information provided by pharmacists~          in the PPVP;~        4. PPVP is an efficient approach to educating patients in the senior center based on its~          costs;~        5. Participating pharmacists will be activated to implement PPVP learnings in their~          practice.~   "
123998|NCT01944449|"~     The objectives of this study are to examine the effects of chronic, (12 weeks) administration~     of Whey protein on HbA1c, and postprandial glucose (PPG).~   "
123999|NCT01944436|"~     Lewy body spectrum disorders are a common group of neurodegenerative diseases that cause~     memory loss, behavioural and motor disabilities that impair quality of life. Cognitive~     enhancers help people afflicted with these conditions. However, some people do not benefit~     from this treatment, while others experience serious side effects. Side effects and poor~     response lead to hospitalization and early institutionalization. Pharmacogenomics, the study~     of how DNA variation can influence drug effects, will be combined with functional changes in~     brain imaging in response to cognitive enhancers in patients with Lewy body disease. The goal~     is to develop a predictive test that can be administered in the clinic to aid physicians'~     choice of initial medication. This can reduce health care costs and improve treatment to~     Canadians suffering from these devastating disorders.~   "
124001|NCT01944410|"~     The traumatic bone cyst (TBC) is an infrequent nonepithelial lined cavity of the jaws, which~     was first expressed by lucassin 1929, the lesion has attracted a great deal of interest in~     the dental literature, but its pathogenesis is still not evidently recognized. It determines~     a bone cavity of irregular shape which appears like a cyst on a radiograph, and~     histopathologically there are no elements to confirm a diagnosis of a cysts. TBC the~     international histological classification assumed by the World Health Organisation for~     odontogenic tumours utilizes the term solitary bone cyst, nevertheless the term traumatic~     bone cyst (TBC) is more extensively used in the literature. The WHO classification explains~     TBC as a non-neoplastic osseous lesion because it demonstrates no epithelial lining, which~     differentiates this lesion from the true cysts. There is general conformity that most~     traumatic bone cysts present without symptoms or signs. Seldom, expansion of the cortical~     plate may occur with extraoral swelling, less commonly there may erosion through the cortical~     bone may take place.' Teeth in the area of involved bone usually remain vital, without root~     resorption or tooth mobility. Treatment of traumatic bone cysts has included surgical~     exploration and curettage to motivate bleeding within the bony cavity,' packing of the cyst~     cavity with Gelfoam which has been saturated with thrombin and penicillin, and bone grafting~     based on previous study Injection of autogeneic blood into the bony cavity of a traumatic~     bone cyst was followed by rapid resolution of the lesion.~      Platelet-rich plasma (PRP) is a rich source of growth factors. The growth factors present in~     PRP are familiar, including transforming growth factor-_ (TGF-_1 and TGF-_2), vascular~     endothelial growth factor, 3 isomers of platelet-derived growth factor (PDGF-__,PDGF-__, and~     PDGF-__), and endothelial growth factor. These growth factors are considered to have the~     capacity to accelerate chemotaxis, mitogenesis, angiogenesis, and synthesis of collagen~     matrix and support tissue repair when applied on bone wounds. Due to this high platelet~     content, PRP has been used in orthopaedic surgery, oral implantology, and periodontics with~     the aim of making the repair process as fast and natural as possible, as it can potentially~     afford considerable tissue improvement in bone and soft tissue in a similar way. PRP is~     easily acquired, rich in cell signalling molecules, completely autogenous and can be obtained~     from minimal blood volumes.the purpose of the present study is to determine the efficacy of~     PRP in the treatment of mandibular TBC.~   "
124002|NCT01944397|"~     We aim to investigate the prognosis of patients diagnosed with AF, particularly in relation~     to the development of subsequent stroke, heart failure, and myocardial infarction. We will~     explore the relationship between these outcomes and a range of risk factors.~   "
124003|NCT01944384|"~     Aim of study: The effects of aldosterone blockade on myocardial remodeling in hypertensive~     patients with diastolic failing heart remains unclarified.~      Background: Nearly half of patients with clinical heart failure (HF) have normal left~     ventricular ejection fraction (LVEF) who usually present with apparent diastolic dysfunction~     (DD) and are referred as diastolic HF (DHF). The renin-angiotensin-aldosterone system is an~     established major pathway that is operative in the pathogenesis of HF. The effects of~     aldosterone on myocardial hypertrophy, fibrosis and endothelial dysfunction have clearly been~     established in human and animal models. Furthermore, in these models, aldosterone antagonism~     prevented the development of myocardial fibrosis independent of its effect on blood pressure~     or myocardial hypertrophy. However, its application to patients with DHF is unspecified. In~     the study, we hypothesize that aldosterone blockade could reverse LV remodeling process in~     hypertensive patients with DHF.~      Study protocol: We will enroll medically well-controlled hypertensive patients who have DHF~     defined as the presence of exertional dyspnea or HF signs/symptoms, diastolic dysfunction as~     impaired tissue-Doppler (TDI) derived mitral early annular diastolic velocity (< 8 cm/s), and~     LVEF > 50 % in echocardiography. All patients will be randomized to receive spironolactone 25~     mg per day or not for at least 6 months. At baseline before randomization and 6 months after~     randomization, we will investigate the Quality-of-life (QOL) score by Minnesota Living with~     Heart Failure questionnaire (Chinese version), echocardiography coupled with TDI to assess~     the degree of LV hypertrophy, myocardial systolic and diastolic characteristics. Otherwise,~     we draw blood sampling at baseline and after randomization for quantifying and comparing~     several biomarkers which are currently proved to be correlated with LV hypertrophy,~     myocardial fibrosis, and biomechanical stretch in DHF patients, such as N-terminal~     pro-brain-type natriuretic peptide, matrix metalloproteinase-2, carboxy-terminal telopeptide,~     procollagen type III amino-terminal propeptide, soluble ST2, and galectin-3. Expected~     results: Aldosterone antagonism is effective for hypertensive patients with DHF by improving~     the quality of life, echo-derived myocardial function, and reducing ventricular mechanical~     stretch through lessening the degree of LV hypertrophy and myocardial fibrosis.~   "
124004|NCT01944371|"~     The purpose of this study is to determine the safety, pharmacology and bioactivity of~     disulfiram in antiretroviral treated HIV-infected adults. The investigators primary~     hypothesis is that 3 days of disulfiram will result in an increase in HIV transcription in~     CD4+ T-cells in patients on suppressive antiretroviral therapy (ART).~   "
124005|NCT01944358|"~     Syphilis and HIV are prone to occur concomitantly and the two diseases share several modes of~     acquisition and risk factors such as men who have sex with men (MSM), sexual workers,~     intravenous drug users, previous history of sexual transmitted diseases (STDs), and multiple~     partners. HIV infection rates of up to 50% have been reported among patients diagnosed with~     syphilis in several regions, with higher HIV infection rates among MSM. Besides, syphilis~     ulcers are proposed to enhance the transmission of HIV. In Taiwan, there is also an~     increasing prevalence of syphilis and HIV co-infection among MSM. Therefore, to treat~     syphilis is an important issue for public health.~      According to literature review, whether patients with HIV and syphilis co-infection had~     higher serologic failure rate remains controversial, especially in the era after highly~     active anti-retroviral therapy (HAART) was introduced since 1996. Ghanem et al recently~     demonstrated that the use of HAART may reduce syphilis failure rates among HIV-infected~     patients who have syphilis. In addition, the treatment guideline in 2006 suggested that the~     treatment of primary syphilis and secondary syphilis is single dose benzathine penicillin G~     regardless of HIV status; however, it goes on to suggest that some specialists recommended~     additional treatments for HIV-infected patients, namely 3 doses, each a week apart. There is~     no reference and evidence of strength of the suggestion but only specialists' opinion.~      In the study, we aim to compare serologic response of syphilis to penicillin treatment~     between HIV-infected and HIV-uninfected patients and to compare serologic response of early~     syphilis (primary or secondary) to 1 dose and 3 doses of benzathine penicillin G among~     HIV-infected patients. A longitudinal follow-up of serologic response will be conducted after~     syphilis treatment.~   "
124006|NCT01944345|"~     The registry has been designed as a prospective, observational program for patients~     undergoing lumbar or cervical fusion using VariLift device with the ultimate goal to aid in~     the development of strategic treatment pathways and improved patient care. All patients who~     agree to participate in the registry will sign an informed consent form and subsequently be~     treated by their surgeon with the VariLift device. Potential treatment procedures include~     bilateral posterior lumbar interbody fusion (PLIF), unilateral transforaminal lumbar~     interbody fusion (TLIF), or bilateral anterior lumbar interbody fusion (ALIF) for the lumbar~     spine, or cervical unilateral or bilateral ACDF procedure. Surgical procedures can be~     performed in either an inpatient or outpatient facility. It is anticipated that the VariLift~     devices will improve patient outcomes and lead to the development of treatment pathways to~     improve patient care.~   "
124007|NCT01944332|"~     In this proposed research study, the investigators plan to assess the efficacy of gametes'~     (egg and sperm) treatment on fertilization as well as pre- and post-implantation embryo~     development.~   "
124008|NCT01944319|"~     To evaluate the clinical and economical benefits of a meropenem dosage strategy based on a~     population pharmacokinetic(PPK)-pharmacodynamic(PD) model in lower respiratory tract~     infection patients.~   "
124097|NCT01943162|"~     This study will test a modification of Cognitive Processing Therapy (CPT) for Post-Traumatic~     Stress Disorder, (PTSD) in which CPT is augmented with compensatory cognitive rehabilitation~     principles from the Cognitive Symptom Management and Rehabilitation Therapy (CogSMART)~     intervention to create a hybrid treatment, SMART-CPT. This study investigates the efficacy of~     SMART-CPT in improving PTSD and post-concussive symptoms, cognition, quality of life, and~     treatment compliance in those with a history of mild to moderate TBI and persistent cognitive~     complaints.~   "
124009|NCT01944306|"~     Contraceptive failure is the primary cause of unintended pregnancy in the United States. With~     obesity rates at epidemic proportions, any association between obesity and strategies that~     prevent undesired pregnancies constitutes a significant public health and economic concern.~     Evidence from recent epidemiological studies and our preliminary data (sub-therapeutic levels~     of steroid hormones due to drug clearance and half-life) suggest that obesity reduces oral~     contraceptive efficacy. Furthermore, preliminary analysis suggested that a sub-group of obese~     women, defined by their own birth weight, are at higher risk of contraceptive failure.~     Further studies are necessary to investigate whether birth weight, a surrogate marker of in~     utero growth restriction, is a useful diagnostic marker for the identification of women prone~     to contraceptive failure. Such an understanding is critical to finding a contraceptive~     strategy with better efficacy for these women.~      The overall goal of this project is to test pharmacokinetics of oral contraceptive agents in~     obese women with low birth weight and compare to obese women with normal birth weight. The~     main hypothesis for this proposal is that an adverse in utero environment programs the~     expression and function of enzymes and transporters that underlie pharmacokinetics of oral~     contraceptives, and leads to contraceptive failure.~      Reproductive-aged, ovulatory women of obese BMI >30 kg/m2 with normal birth weight (5.5-8~     lbs; n=10) and low birth weight (<5.5 lbs; n=10), will be placed on oral contraceptives for 1~     month. At several key time points, synthetic steroid pharmacokinetics, gonadotropins~     (luteinizing hormone, follicle-stimulating hormone) and ovarian hormone levels (estradiol,~     progesterone) will be monitored.~   "
124010|NCT01944293|"~     This study is designed to compare the effectiveness of two medications, Ketamine and~     Midazolam, for rapidly relieving suicidal thoughts in people suffering from bipolar~     depression.~      The first drug, ketamine, is an experimental antidepressant that early studies have shown may~     quickly reduce suicidal thoughts, but we are not sure how well it may work. Midazolam, the~     comparison drug, is not thought to reduce depression or suicidal thoughts.~   "
124011|NCT01944280|"~     Primary Aim. The primary aim is to determine the effectiveness of intradialytic massage on~     the frequency and severity of cramping among hemodialysis patients prone to lower extremity~     cramping during treatment.~      Hypothesis: Compared to control patients, intervention patients will be significantly less~     likely to have intradialytic cramping that requires staff intervention or treatment~     termination.~      This is a study involving 32 (16 intervention, 16 control) hemodialysis patients with~     frequent lower extremity cramps during treatment. Frequent cramping during dialysis~     treatments is defined as 1 or more episodes of lower extremity cramps during or after~     dialysis over the previous 2 weeks. Cramping frequency will be determined by chart notes.~     Muscle cramping is defined as contraction of the large muscle group of the lower extremities~     sufficiently painful to require intervention by the dialysis staff for relief.~      The intervention group will receive a 20 minute massage of the lower extremities by a trained~     and licensed massage therapist during each treatment (3x per week) for 2 weeks. The control~     group will receive usual care by dialysis center staff.~   "
124012|NCT01944267|"~     This research study is looking at three different procedures for improving the oral mucosa~     (membrane) around dental implants. The three procedures will be the standard procedure, the~     standard procedure with the use of tissue harvested from the mouth and the standard procedure~     with the use of Mucograft membrane product. An advantage claimed by the Mucograft~     manufacturer is increased patient comfort due to lack of tissue harvesting from the mouth.~     Pain and discomfort levels will be evaluated for each of the procedures. Gain in oral mucosa~     and the visual will also be evaluated.~   "
124013|NCT01944254|"~     The intention of this study is to determine whether the precision of the measure of cardiac~     output can be optimized by conducting the measurement while the participant is instructed to~     exhale slowly. This will be compared to measurements done at random to respiration and timed~     with the participant's spontaneous expiration.~   "
124014|NCT01944241|"~     Over the last 20 years, cervical screening programs have had huge success in reducing~     cervical cancer rates. These programs have done this by screening women at risk of developing~     cancer with regular smear tests. Women with abnormal smears are followed up in colposcopy~     clinics, and where needed, cervical surgery is performed to remove pre-cancerous areas on the~     cervix.~      Surgery to the cervix can include LLETZ (Large loop excision of the transformation zone)~     treatment or cone biopsy. Many studies in the last few years have looked at the impact that~     this necessary surgery can have on the function of the cervix. These studies have mainly~     found an association between LLETZ treatment and an increased risk of preterm labour. There~     have been no large studies investigating the effect cervical surgery may have on fertility.~      The investigators would like to examine the impact that cervical surgery may have on a~     woman's future fertility. It has been postulated that cervical surgery may cause the cervix~     to close, preventing sperm getting through or that it may cause changes in the secretions of~     the cervix, secretions that are necessary for normal interaction with sperm.~      The investigators would like to send a questionnaire to women who have attended colposcopy.~     The investigators will ask these women a series of questions relating to fertility desires~     and divide the women in to two groups depending on whether the women needed cervical surgery~     for pre-cancerous lesions or not.~      Hypothesis: That cervical surgery has an impact on the function of the cervix and on~     fertility.~   "
124015|NCT01944228|"~     The purpose of this study is to assess the effect of transvenous vagus nerve stimulation~     (tVNS) on the immune response.~      In the human endotoxemia model, intravenously administered endotoxin (lipopolysaccharide~     [LPS]) elicits a systemic immune response with release of pro-inflammatory cytokines, such as~     TNF α. This trial will determine if an anti-inflammatory effect can be produced by acute VNS~     using a minimally invasive delivery method.~   "
124016|NCT01944215|"~     The primary objective of this study is to determine if exercise, fasting, or eating prior to~     the molecular breast imaging study will have an effect on the uptake of the tracer in the~     breast tissue.~   "
124130|NCT01942733|"~     To assess effects of brexpiprazole on sleep patterns of depressed patients with sleep~     disturbances.~   "
124131|NCT01942720|"~     This study is designed to evaluate the performance of VCE in the assessment of mucosal~     inflammation 6 months after the first VCE procedure~   "
128769|NCT01881919|"~     The purpose of this study was to test the effect of chronic consumption of Quercetin 500 mg~     tablets on blood uric acid and other biomarkers in adult males.~   "
124017|NCT01944202|"~     It is well documented that the proportion of inappropriate transthoracic echocardiograms~     (TTEs) is highest in the ambulatory environment, where it has been reported as high as 30%.~     Therefore, the potential to improve TTE utilization may be greatest in the outpatient~     setting. However, no study to date has evaluated whether an Appropriate Use Criteria~     (AUC)-based educational intervention can reduce inappropriate TTEs in this setting. The~     investigators therefore designed the first randomized control trial of an AUC-based~     educational and feedback intervention aimed at reducing inappropriate outpatient TTEs ordered~     by cardiology and internal medicine physicians in training.~   "
124018|NCT01944189|"~     Despite preventive programs, effective case management is still the cornerstone in malaria~     control.~      This study is as a strategy towards improved recommendations in resource limited countries~     during artemether -lumefantrine (AL) treatment in order to maximize the public health~     benefits.~      This is observational population pharmacokinetics study with a nested comparative~     bioavailability study.The study is intended to describe the variability in lumefantrine blood~     levels among under five year old Ugandan children with uncomplicated falciparum malaria~     receiving current standard artemether-lumefantrine dose regimens. Findings will form a basis~     for development of rational dosage recommendations. The nested comparative bioavailability~     study will explore effect of profiled local food intake (maize porridge plus vegetable oil~     versus milk) on lumefantrine uptake. As a strategy towards improved recommendations in~     resource limited countries during AL treatment in order to maximize the public health~     benefits. As a secondary objective we will correlate the variability in lumefantrine uptake~     to malaria treatment outcome and safety profile in this population.~      Research hypotheses~        1. The population pharmacokinetic profile of lumefantrine among under five year old~          children in Uganda with uncomplicated falciparum malaria is not affected by demographic~          factors.~        2. There is no difference in the bioavailability of lumefantrine when~          artemether-lumefantrine is received with maize porridge plus vegetable oil versus milk~          among under five year old Ugandan children treated for uncomplicated falciparum malaria.~   "
124019|NCT01944176|"~     Airway inflammation is partly driven by Th17 and Th17-polarizing cytokines that is~     steroid-resistant. Statins could suppress IL-17 cytokines in other diseases such as~     atherosclerosis and multiple sclerosis in mouse model. The investigators hypothesize that~     statins might provide anti-inflammatory benefit of suppressing IL-17 cytokines in COPD~     patients.~   "
124020|NCT01944163|"~     Rationale: Axial spondyloarthritis (axSpA) is an inflammatory back pain disorder affecting up~     to 24% of young chronic low back pain (CLBP) patients. For general practitioners (GPs) it is~     difficult to distinguish axSpA patients in the large amount of CLBP patients. In previous~     studies a referral rule for axSpA applicable in CLBP patients was developed and validated.~     The next step is to investigate the impact of the referral rule in daily practice. This~     impact analysis will test if the referral rule will be beneficial or harmful.~      Objective: To evaluate the clinical impact of a referral rule in young patients presenting at~     the general practitioners with chronic low back pain, who are at risk for axSpA, compared to~     usual care.~      Study design: A cluster randomized clinical trial. Study population: Primary care patients~     with chronic low back pain, aged 18-45 years.~      Intervention (if applicable): GPs are randomized in clusters either to use directly the~     referral rule or use the referral rule after 4 months. The referral rule consists out of four~     variables, a positive ASAS inflammatory back pain questionnaire, a positive family history~     for spondyloarthritis, a good reaction to NSAIDs (non-steroidal anti-inflammatory drugs) and~     back pain duration longer than 5 years. If at least two out of four variables are present a~     referral to the rheumatologist is advised.~      Main study parameters/endpoints: The primary outcome is a change in the Roland Morris~     Disability Questionnaire (RMDQ) compared to baseline in the CLBP patients with or without use~     of the referral model.~      Secondary parameters: Quality of life measurements, cost-effectiveness, pain and fatigue and~     referral to rheumatologist and diagnosis of axSpA.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness:~      The burden and risks associated with participation are minimal. No medical intervention is~     taken place. If the GP of the patients is randomized to the referral model, the patient is~     checked for the risk of axial spondyloarthritis, by the non-invasive referral model. If the~     referral model is positive a referral to the rheumatologist is advised. Is the GP is~     randomized to the 'usual care' there is no difference in the treatment of low back pain than~     nowadays. A GP is still allowed to treat the CLBP patients optimal and a referral to the~     rheumatologist is allowed but not actively advised.~      All participating CLBP patients are asked to fill several questionnaires at four different~     time points, at baseline, after 12 months and after 24 months. In total there are 8~     questionnaires and four separate questions. The questionnaire are designed to fill out by the~     patient themselves. The total time to fill in the questionnaire is estimated to be 30~     minutes.~      The benefits of the study are:~        -  For the CLBP patients, up to 24% of the back pain complaints are caused by axSpA, but~          the GPs are not (yet) aware of this disease. When a CLBP patient is participating in~          this study, the chance of having axSpA as cause for the back pain is investigated. This~          a benefit for a CLBP patients since there is effective treatment for axSpA.~        -  For the GP it is very difficult to distinguish an axSpA patients in the large amount of~          CLBP patients. If it appears that the validated referral rule has an impact on CLBP and~          GPs, the next step will be implementation of this referral model in daily practice and~          it will become a helpful tool for the GP.~        -  For the society, CLBP is a great socioeconomic burden for the society. When one of the~          causes for CLBP, namely axSpA is diagnosed and treated in an earlier stage this will~          lead to a decreased sick leave because of back pain and is therefore potentially~          cost-effective.~   "
124021|NCT01944150|"~     At Saint-Antoine's hospital, in CETD a multidisciplinary team takes care of patients with~     chronic pain. Free-drug techniques are available to reduce their consumption of analgesics.~     This study is to assess the relief obtained by the simultaneous combination of these two~     techniques: transcutaneous electrical nerve stimulation and hypnosis.~   "
124022|NCT01944137|"~     The main purpose of this study is to examine changes in patient-reported symptoms during the~     first two cycles of neoadjuvant or adjuvant chemotherapy for non-small cell lung cancer~     (NSCLC), colorectal cancer (CRC) and breast cancer, among patients who receive standard care~     plus a proactive nursing intervention relative to patients who receive standard care alone.~     Interventions to improve symptom management and prevent urgent care needs in both the clinic~     and hospital for patients receiving chemotherapy with curative intent are needed to enhance~     the quality of cancer care.~   "
124023|NCT01944124|"~     Cardiovascular diseases are the leading cause of death among Canadians. In those with~     diabetes, cardiovascular complications are responsible for more than 70% of deaths. While~     there is much interest in identifying and treating risk factors, the exact biological~     mechanisms, their measurement and optimal ways to prevent and manage them are poorly~     understood.~      Physical activity and regular exercise can prevent diabetes and effectively manage risk~     factors, but most Canadians do not exercise enough to beneficially manage risk. Tailored~     exercise prescribed by a family physician has shown promise as a means to increase fitness~     and reduce risk, but optimal implementation practices remain unknown - especially in rural~     and remote communities with reduced access to healthcare. Mobile health technologies have~     proved to be a beneficial tool to achieve blood pressure and blood glucose control in~     patients with diabetes. These technologies may address the limited access to health~     interventions in rural and remote regions. However, the potential as a tool to support~     exercise-based prevention activities unknown.~      Therefore, this study was undertaken to investigate the effects of a tailored exercise~     prescription alone or supported by mobile health technologies to improve cardiovascular risk~     factors in rural community-dwelling adults at risk for cardiovascular disease and type 2~     diabetes.~      Adults with cardiovascular risk factors were recruited from rural communities and randomized~     to either: 1) an intervention group receiving an exercise prescription and devices for~     monitoring of risk factors with a smartphone data portal equipped with a mobile health~     application; or 2) an active control group receiving only an exercise prescription.~      It was hypothesized that the intervention group would reduce their risk to a greater extent~     than the active control group following 12 weeks, and that these improvements would be better~     maintained in the intervention group at 24 and 52 weeks compared to the active control group.~   "
124024|NCT01944111|"~     Compare plicated laparoscopic adjustable gastric banding to standard laparoscopic adjustable~     gastric banding in prospective clinical trial.~   "
124025|NCT01944098|"~     The primary objective is to assess the feasibility and safety of administering continuous~     intraoperative lidocaine infusions in adult patients undergoing laparoscopic Roux en Y~     Gastric Bypass (RYGB). The secondary objective is to determine if lidocaine administration~     versus placebo (dextrose administration) (initiated at the time of anesthesia induction and~     continued until extubation) will reduce postoperative narcotic requirements.~   "
124026|NCT01944085|"~     This is a simple randomised clinical trial to study if non-narcotic analgesia reduces the~     pain score and pulse rate of children who undergo removal of percutaneous pins in the~     outpatient clinic.~      Inclusion criteria:~        -  5-12 years of age~        -  2 or 3 percutaneous pins in either elbow~      Exclusion criteria:~      - documented or suspected allergies to acetaminophen, ibuprofen~      Patients enrolled in the study are instructed not take additional analgesia prior to the~     clinic visit (risk of overdosage explained). This is verified by clinic nurses conducting the~     trial.~      At the clinic visit, they are randomized into one of three groups~      1. acetaminophen; 2. ibuprofen; or 3. Vitamin C (Placebo).~      They are served the `medication' (weight-appropriate dose) and the pins are removed in the~     clinic an hour later.~      Pain score (Wong-Baker scale) and pulse rate are measured before pin removal, immediately~     following pin removal, and 10 minutes after pin removal.~      The study hypothesis is that non-narcotic analgesia (such as acetaminophen and ibuprofen) do~     not decrease pain score and pulse rate associated with the pin removal procedure.~   "
124229|NCT01941446|"~     This is a randomized, placebo- and positive-controlled (moxifloxacin), 3-period, 3-way~     crossover thorough QT study, which includes a Screening Period, Treatment Periods (1 through~     3), and a Follow-up Visit. Subjects will be confined to the investigational site for 4~     nights/3 days during Period 1 and for 3 nights/2 days during Periods 2 and 3. There will be a~     minimum of a 14 day washout between treatments.~   "
124027|NCT01944072|"~     Trial design: An equivalence/non-inferiority randomized controlled trial with parallel group~     design studied the effect of two aerobic exercise-training intensities in COPD~     patient-centered outcomes. Methods: Thirty-four COPD clinically stable patients stratified~     from mild to very severe GOLD stages, were blinded to 60 or 80%Wmax aerobic exercise training~     intensity in an outpatient pulmonary rehabilitation program, between 2009-2010. Outcomes were~     assessed with St.George's respiratory questionnaire (primary outcome), Mahler dyspnea index,~     London Chest activity of daily living scale, 6-minute walk, constant load and incremental~     exercise tests. Patient's allocation sequence was computer-generated, with consignment in a~     safe deposit box.~   "
124028|NCT01944059|"~     The purpose of this study is to evaluate the efficacy of Theramine® as a preventative for~     migraine headaches.~   "
124029|NCT01944046|"~     The purpose of this research study is to learn about the effects of intranasal oxytocin as a~     supplemental treatment for improving social difficulties in children and adolescents with~     autism. This study will also provide additional information about the safety and tolerability~     of intranasal oxytocin. Investigators expect oxytocin will increase social motivation,~     improving daily living skills and quality of life.~   "
124030|NCT01944033|"~     The effectiveness of β2-agonists in the treatment of exacerbations of COPD is already~     established. The purpose of this study is to compare the effectiveness of the β2-agonists~     alone in nebulization with the association β2-agonists + Ipratropium bromide in the treatment~     of an acute exacerbation of COPD consulting the emergency departement based on the clinical~     and arterial blood gas.~   "
124031|NCT01944020|"~     Obstructive sleep apnea (OSA) is characterized by recurrent episodes of partial or complete~     loss of airflow during sleep, due to narrowing or closure of the upper airway. The resulting~     hypoxia has many cardiometabolic consequences, and leads to a disruption of sleep quality~     including reductions in the expression of rapid eye movement (REM) sleep and slow wave sleep~     (SWS). Patients also frequently experience excessive daytime sleepiness (EDS), which, when~     present with OSA, defines the clinical entity OSA syndrome (OSAS). Obesity is the leading~     risk factor for the development of OSA. Interestingly, it has been suggested that the~     disorder itself may contribute to further weight gain, presenting a vicious cycle wherein OSA~     and obesity perpetuate each other. OSAS may promote weight gain by placing patients in a~     state of positive energy balance characterized by low levels of physical activity and~     disrupted patterns of appetite-regulating hormones. Continuous positive airway pressure~     (CPAP), the gold-standard treatment of OSAS, may improve energy balance in these patients,~     although this has not yet been adequately studied. The current proposal will investigate the~     effects of 2 months of CPAP on energy balance and cardiovascular risk in obese patients with~     moderate-to-severe OSA and EDS. Patients will be instructed to use CPAP at home each night~     throughout the 2-month treatment phases. At baseline and at the conclusion of the 2-month~     treatment phase, the investigators will measure levels of free-living physical activity,~     sleepiness, sleep quality, body composition, cardiovascular risk factors, appetite-regulating~     hormones, hunger, and ad libitum food intake. It is hypothesized that active compared to sham~     CPAP treatment will result in improvements in energy balance, including increased physical~     activity, reductions in abnormally high levels of circulating leptin levels, and reductions~     in hunger, food intake, and cardiovascular risk factors. These improvements are hypothesized~     to be associated with increases in the expression of REM sleep and SWS, and reduced EDS as a~     result of CPAP.~   "
124032|NCT01944007|"~     This is a dose-escalation study to determine the effect of CLP in normal healthy volunteers.~   "
124033|NCT01943994|"~     One of the most promising lines of investigation for the therapeutic use of hallucinogens in~     the 1960s and 1970s was in the treatment of drug dependence. We propose to examine psilocybin~     administration combined with a structured smoking cessation treatment program in nicotine~     dependent individuals in order to provide preliminary data on the efficacy of this combined~     treatment for smoking cessation. Prior work in our laboratory has shown that under carefully~     prepared and supportive conditions, psilocybin administration can facilitate highly salient~     experiences with enduring personal meaning and spiritual significance (Griffiths et al.,~     2006, 2008). It is plausible that embedding such highly meaningful experiences into a drug~     dependence cessation attempt may provide an enduring motivation for remaining abstinent.~     Cigarette smoking is a good model system for studying drug dependence because users are less~     likely to be challenged by the many social and economic impairments that often accompany~     dependence on other drugs such as cocaine, heroin, or alcohol. More specifically, we propose~     to conduct a randomized controlled comparative efficacy study in which either psilocybin or~     transdermal nicotine patch are administered under highly supportive conditions to individuals~     who are nicotine-dependent cigarette smokers, who have had multiple unsuccessful quit~     attempts, and who continue to desire to quit smoking. Other than nicotine dependence,~     participants will be healthy. Fifteen participants have already completed a preliminary~     open-label pilot-study with no control condition. Eighty additional participants will be~     enrolled and randomized to either psilocybin (n=40), or nicotine patch (n=40) treatment.~     Participants will receive a 13-week course of cognitive behavioral therapy for smoking~     cessation, with Target Quit Date set for week 5. After several preparation meetings with~     study monitors, participants will have either a single day-long psilocybin session using a~     high dose (30 mg/70 kg), or a standard 8 to 10-week course of nicotine patch treatment.~     Participant smoking status will be assessed repeatedly for 8 weeks after the Target Quit~     Date, including biological verification of smoking status through breath and urine samples.~     Smoking status will also be assessed at three follow up sessions approximately 3, 6, and 12~     months after the Target Quit Date. Additionally, 50 of these participants (25 per treatment~     condition) will undergo MRI scanning before and after Target Quit Date to assess the~     brain-based mechanisms associated with these treatments. Individuals assigned to the nicotine~     patch study treatment condition will be eligible to undergo an optional high dose psilocybin~     session after completing the 6-month follow-up meeting.~   "
124034|NCT01943981|"~     Heart failure and stroke are the two major complication of atrial fibrillation. Current~     treatment for atrial fibrillation is so focused to stroke prevention, but the risk assessment~     for heart failure is less highlighted. The most of patients with atrial fibrillation have~     cardiac functional limitation of variable degree. We hypothesize that the exercise test would~     reveal the subclinical cardiac dysfunction, and might be helpful to classify the patients~     with atrial fibrillation according to their exercise capacity real cardiac function.~   "
124035|NCT01943968|"~     The aim of our study is to find a biomarker for fibrosis or vasculopathy in systemic~     sclerosis. We will evaluate a possible correlation between semaphorin 7a, semaphorin 3a and~     lysyl oxidase and fibrosis (lung and skin) or vasculopathy in patients with systemic~     sclerosis. The results obtained may help us diagnose these complications of systemic~     sclerosis and hopefully even monitor patient treatment.~   "
124036|NCT01943955|"~     It is hypothesized that a home-based computer gaming rehabilitation program will improve gaze~     control and balance impairments in those with peripheral vestibular disorders (PVD). Ten~     people with peripheral vestibular disorders were started on a treatment program that~     consisted of playing computer games and while performing various balance exercises. On a~     weekly basis, each participant was contacted by email or telephone and asked to submit their~     computer gaming data to a trained vestibular physical therapist. Following review of this~     data, the physical therapist would contact the participant and progress their computer gaming~     program appropriately. At the completion of twelve weeks of home treatment, the participants~     returned for re-assessment and it was determined that the computer gaming program was an~     effective treatment for those with PVD. It was also determined that a monitored~     telerehabilitation program was an efficient and effective delivery method for this treatment.~   "
124230|NCT01941433|"~     The purpose of this study is to determine whether an online patient passport tool called the~     Arthritis Health Journal can assist people with rheumatoid arthritis in managing their~     disease.~   "
124037|NCT01943942|"~     The objective of this study was to confirm if two formulations of montelukast tablets are~     bioequivalent.~      Test product was Montelukast (10 mg tablets; GlaxoSmithKline) and reference product Singulair~     (10 mg tablets; Merck Sharp & Dohme). The single dosage was one tablet.~      The study was prospective, open-label, randomized, crossover, single dose, with 02~     treatments, 02 sequences and 02 periods, under fasting conditions.~      The population was composed of 32 healthy volunteers, both genders, adults between 18-50~     years.~      The comparative bioavailability of the two formulations was evaluated based in statistical~     comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations~     in blood.~   "
124038|NCT01943929|"~     Headache is the most common complaint to neurologists. In the 80´s and 90's few papers, with~     limited number of patients, have proposed the association between nasal septum contact and~     headache. The International Classification of Headaches Disorders proposed specific~     diagnostic criteria for this entity.~      With the major use of CT scans, the contact between nasal mucosa and septum is daily observed~     in many patients without complaint of headache.~      The purpose of this study is to determine if there is any correlation between nasal and~     septum mucosa contact and the prevalence of headache. The investigators hypothesized that no~     correlation will be found using CT scans in a large series of patients.~   "
124039|NCT01943916|"~     This is a prospective controlled multi-center study involving gray scale (B-mode) ultrasound~     vs OA/US (opto-acoustic and gray scale ultrasound) for the visualization of suspicious~     masses. Imagio gray scale and OA image sets will be collected on each enrolled mass and~     pushed to an Imaging Core Lab for processing and then to a set of Independent Readers who~     will read the Imagio gray-scale images vs the Imagio OA/US images.~   "
124040|NCT01943903|"~     The objective of the PLATFORM Study is to compare clinical outcomes, resource utilization,~     and quality of life (QOL) of FFRCT-guided evaluation versus standard practice evaluation in~     patients with suspected CAD in order to further inform patients, health care providers, and~     other stakeholders about which technologies are most effective and efficient in the diagnosis~     of CAD~   "
124041|NCT01943890|"~     Background Nebulised hypertonic saline (HS) is an established basic airway clearance~     treatment in Cystic Fibrosis (CF). However, there is scarce evidence regarding the practical~     implementation and administration of different HS volumes, including physiotherapy and~     aspects of breathing pattern.~      The aim of the study was to implement standardised and age-adjusted nebulised volumes of~     hypertonic saline in cystic fibrosis patients, included in physiotherapy and lung drainage~     techniques.~   "
124042|NCT01943877|"~     This study was conducted to evaluate by clinical and microbiological parameters the effect of~     locally delivered propolis as an adjunct to scaling and root planing in the treatment of~     chronic periodontitis.~   "
124043|NCT01943864|"~     This is a Phase IIa, open-label, single-arm, multi-center study to evaluate the efficacy and~     safety of orally administered MEK inhibitor trametinib as the second line in subjects with~     advanced or metastatic biliary tract cancers (BTC) in Japanese population. The primary~     endpoint of this study is 12 week non-progressive disease (PD) rate defined as the percentage~     of subjects without progression at Week 12. As a sub-study, pharmacokinetics (PK) of four~     tablets of 0.5 milligram (mg) tablet, or one tablet of 2 mg tablet to achieve 2 mg daily~     regimen will be assessed to evaluate the pharmacokinetics of trametinib in Japanese~     population.~      Eligible subjects will be randomized to receive trametinib at the recommended Phase II dose~     of 2 mg every day as one 2 mg tablet or four 0.5 mg tablets on Day 1. From Day 2 until~     disease progression or withdrawal from the study treatment, all subjects will receive one~     tablet of 2 mg trametinib . Disease assessment will be performed every 8 week. Translational~     research is also planned to evaluate the potential blood or tumor tissue-derived biomarkers~     for biological activity, and sensitivity or resistance to treatment with trametinib .~   "
124044|NCT01943851|"~     This is an open-label repeat dose, multicenter, 2-part study to determine the maximum~     tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) for GSK525762 given once-daily~     (QD) orally. Part 1 of the study is a dose escalation phase to select the recommended Part 2~     dose (RP2D) based on the safety, PK, and PD profiles observed after oral administration of~     GSK525762. Eligible subjects with select relapsed refractory hematological malignancies~     (acute myeloid leukemia [AML], non-Hodgkin's Lymphoma [NHL]and multiple myeloma [MM]), will~     be enrolled in the QD and/or BID dosing cohorts until a MTD is established. Subjects may~     continue treatment in the study until disease progression, unacceptable toxicity, or~     withdrawal of consent. . Upon determination of the MTD, twice daily (BID) dosing cohorts may~     be opened to collect additional safety data and evaluate the preliminary efficacy of~     GSK525762 administered BID. Part 2 will explore clinical activity at the MTD or RP2D;~     separate expansion cohorts will be planned for acute myeloid leukemia (AML), non-Hodgkin's~     Lymphoma (NHL, including an exploratory sub-cohort of subjects with myc and B-Cell Leukemia~     (BCL)2 and/or BCL6 rearrangements/overexpression [double- and triple-hit lymphoma]), and~     multiple myeloma (MM). This is the first study of this agent to be conducted in subjects with~     these relapsed and/or refractory hematological malignancies for which no standard therapies~     are anticipated to result in a durable remission.~   "
124045|NCT01943838|"~     Primary Objective:~      - To assess the safety, tolerability and plasma pharmacokinetics (PK) of SAR245408 given once~     daily as a tablet formulation of polymorph E in subjects with solid tumors or lymphoma.~   "
124046|NCT01943825|"~     The aim of the study is to evaluate a compressed dosing schedule and the immunologic effects~     of co-administration of a flavivirus with JE vaccine.~      Primary Objectives:~        -  To describe and compare the humoral immune response to each of the 4 parental dengue~          virus serotypes at baseline and 28 days after each CYD dengue vaccine dose.~        -  To describe the persistence of the humoral immune response to each of the 4 parental~          dengue virus serotypes 6 months after CYD dengue vaccine Dose 3, irrespective of whether~          or not JE vaccine has been previously administered.~      Secondary Objectives:~        -  To describe the safety profile after each injection of CYD dengue vaccine.~        -  To describe the humoral immune response to each of the 4 parental dengue virus serotypes~          at baseline and 28 days after each CYD dengue vaccine dose when administered with or~          after JE virus vaccine.~        -  To describe the persistence of the humoral immune response to each of the 4 parental~          dengue virus serotypes at six months post-Dose 3 in all four groups and at 12 months~          post dose 3 in Groups 1 and 3 with the compressed schedule.~        -  To describe the JE humoral immune response 28 days after each injection of CYD dengue~          vaccine.~   "
124049|NCT01943786|"~     Adenocarcinoma of the colon and rectum is a common, serious disease and it is the second~     cause of death from cancer in Spain.~      The prognosis of CRC depends to a great extent on its stage when diagnosed. Patients with~     advanced disease, who present up to 40% of all patients, have a poor prognosis. Although the~     application of modern chemotherapy and radiotherapy treatments obtains median survival~     periods of around 24 months, the proportion of patients with advanced disease who obtain a~     cure is low.~      Systemic treatment of advanced CRC has changed considerably in the last ten years with the~     introduction of active drugs such as oxaliplatin, irinotecan, and capecitabine. The most~     commonly used first line regimens are 5-Fluorouracil-Leucovorin-Oxaliplatin (FOLFOX),~     Capecitabine-Oxaliplatin (XELOX), 5-Fluorouracil-Leucovorin-Irinotecan (FOLFIRI) and, to a~     lesser extent, Capecitabine-Irinotecan (XELIRI). Chemotherapy regimens are combined with~     different agents against therapeutic targets, three of which are effective in colon cancer:~     bevacizumab, which targets vascular endothelial growth factor (VEGF) and cetuximab or~     panitumumab, which target the epidermal growth factor receptor (EGFR).~      The use of cetuximab and panitumumab is not recommended in patients with KRAS mutations and~     the combination of a VEGF and EGFR agents is not beneficial.~      Two recent studies results have identified KRAS mutations as frequent drivers of acquired~     resistance to cetuximab and panitumumab in colorectal cancer patients. The conclusions~     indicate that the emergence of KRAS mutant clones can be detected non-invasively months~     before radiographic progression by a DNA Blood Test (Inostics´BEAMing Technology).~      Centro Integral Oncológico Clara Campal (CIOCC) is aiming to undertake a pioneer project~     aimed at integrating the analysis of KRAS switch status by BEAMing Technology in patients~     with metastatic colorectal cancer, tumor KRAS wild-type and BEAMing wild-type treated with~     first line FOLFIRI-cetuximab~      In naive chemotherapy tumor-KRAS wild-type metastatic colorectal cancer patients, who are~     BEAMing positive (KRAS mutated in blood) before treatment may have worse evolution in terms~     of PFS (progression Free Survival) and response rate than BEAMing negative (KRAS native in~     blood) patients.~      To know the proportion of patients who are BEAMing positive (KRAS mutation can be detected in~     circulating extracellular DNA) at the beginning of treatment, could be of great importance~     for treatment efficacy.~   "
124050|NCT01943773|"~     Purpose: To compare post-operative functional outcomes in patients undergoing preoperative~     functional prehabilitation versus standard of care preoperative management in older adults~     undergoing major elective operations.~      Hypothesis: Older adults undergoing preoperative functional prehabilitation (nine sessions of~     home physical therapy over three weeks) will have improved physical function and reduced~     delirium in comparison to usual preoperative care following major abdominal and thoracic~     operations.~      Specific Aims:~      (#1) To compare the difference in the timed up-and-go, Mini Mental Status Exam (MMSE), the de~     Morton Mobility Index, Modified Physical Performance Test (MPPT), and short physical~     performance battery scores in the control and intervention groups at the preoperative and~     initial assessment timepoints.~      (#2) To compare the difference in the timed up-and-go, Mini Mental Status Exam (MMSE), the de~     Morton Mobility Index, Modified Physical Performance Test (MPPT), and short physical~     performance battery scores in the control and intervention groups at the 60-days~     postoperative and the initial assessment timepoints.~      (#3)To compare the rates of ICU delirium and need for post-discharge institutionalization in~     patients in the control and interventions groups.~      (#4) To compare post-operative complications~   "
124051|NCT01943760|"~     Tramadol is a centrally acting analgesic, is primarily Indicated for the treatment of acute~     pain, moderate to severe. The hernioplasty in children is an outpatient procedure, and the~     possibility of postoperative analgesia with fewer systemic adverse effects such as nausea and~     vomiting make the tramadol infiltration a technique of interest. There is controversy about~     its effectiveness.~      The local effect of tramadol in hernioplasty was also studied by researchers with some better~     postoperative analgesia than with local anestetic .~      There are few studies with administration of tramadol for hernioplasty, Which led to the~     interest in this study.~   "
124052|NCT01943747|"~     To mark 10 years of the Surviving Sepsis Campaign (SSC), and timed to coincide with World~     Sepsis Day, on September 13, 2013, the SSC, ESICM and SCCM will be conducting an~     international point prevalence study of severe sepsis and septic shock. The goal of this~     project is to determine the world wide burden of severe sepsis and define current practices~     of sepsis care internationally. The study is a simple data collection exercise for patients~     presenting with either severe sepsis or septic shock on World Sepsis Day.~   "
124053|NCT01943734|"~     Objective: To verify the influence of information passed during anthropometric assessment~     would have in physical exercise (PhE) and eating habits of 14 participants (female=11;~     51,07+-8,17 years) from the Stretch Break Program of Federal University of Paraíba (SBP of~     FUPb). Methods: The research was a descriptive cross-sectional quantitative and qualitative~     approach. Were applied, between March and May of 2010, anthropometric evaluation and~     semi-structured interviews. During the evaluation were provided information and guidance on~     health.~   "
124054|NCT01943721|"~     The objective of this Phase 1 study is to evaluate the VISION5 Product's safety and efficacy.~   "
124055|NCT01943708|"~     This single-blind randomised crossover trial aims to compare the efficacy of a novel~     Auto-CPAP algorithm (SPAP) to conventional CPAP. Up to 50 patients will be recruited from an~     OSA population, aged over 18.~   "
124056|NCT01943695|"~     The purpose of this study is to compare the effects of aerobic exercise training during and~     after chemotherapy for women who have recently been diagnosed with early-stage breast cancer.~   "
124057|NCT01943682|"~     The purpose of this study is to test the safety of a study drug called CPX-351. This drug has~     been tested in adults but not yet in children and adolescents. This study tests different~     doses of the drug to see which dose is safer in children and adolescents.~      Patients who have blood cancer are being asked to take part in this study . Blood cancers may~     include leukemia and lymphoma. Patients able to be in this study have already been treated~     with standard chemotherapy for their disease and the disease is still growing or has come~     back.~      CPX-351 is a drug that is not yet approved by the United States Food and Drug Administration~     (FDA) and is only used in research studies like this one. CPX-351 is made up of two~     chemotherapy drugs that patients may have already received called cytarabine and daunorubicin~     that are now packaged together.~      Another purpose of this study is to collect blood samples for special research studies.~     Researchers want to study how much of the CPX-351 is in the body over time. These studies are~     call pharmacokinetic studies or PK studies for short. PK studies require the collection of~     several blood samples before and after participants are given the study drug.~   "
124132|NCT01942707|"~     46 female postbariatric patients will be submitted to anchor-line abdominoplasty with drains~     insertion. Patients will be randomized to two groups. One group will have the Fascia Scarpa~     removed and in the other the Fascia Scarpa will be preserved. The drains will be removed when~     the volume is less than 30 ml in 24 hours. The primary outcome will be the volume of total~     drainage obtained in the drains of the abdominal region. Secondary outcomes will be the~     length of time the drains remain and the presence of seroma assessed by ultrasound on the~     twentieth postoperative day.~   "
124058|NCT01943669|"~     In this study, 10 volunteer participants with chronic spinal cord injury will undergo a~     10-week training schedule for ambulation with the ReWalk™ device. The ReWalk™ consists of a~     lightweight brace-support suit containing motors at the hip and knee joints, rechargeable~     batteries and a computerized control system carried in a backpack. ReWalk™ users control~     their ambulation through subtle changes in centre of gravity and upper-body movements.~     Before, during and after training sessions the volunteers will perform standardised~     assessments and complete questionnaires to assess the functional and psychological effects of~     the exoskeleton. Functional outcomes primarily focus on ambulation outcomes and psychological~     outcomes primarily focus on predisposition and perceptions of disability. The outcomes of~     this pilot study will assist the investigators in the preparations of randomised controlled~     trail for assessing the efficacy of the ReWalk™ device in a neurorehabilitation setting.~   "
124059|NCT01943656|"~     As technologies are advancing quickly in the healthcare setting, new solutions have become~     available helping disable people to enhance their ability to communicate. One of these~     advances is the introduction of the 'eye gaze system'. Through processing eye movements, this~     device allows a person to write, speak, use the Internet and even control systems in the home~     or office. In the currently proposed study we aim to evaluate the psychological and~     functional effects of using the Tobii™ Eyegaze System by inpatients with tetraplegia who are~     unable to use arms and legs and sometimes are not able to talk because of an impaired~     respiratory function.~      Volunteering inpatients will be recruited at the National Spinal Injuries Centre. Volunteers~     will be instructed and trained to use the Tobii™ Eyegaze System. The number of sessions~     required to successfully master the device depends on the learning curve of the patient. The~     progress will be documented accordingly. After successful completion of the training and~     supervised use, the inpatients will be offered the Tobii™ Eyegaze System for unsupervised~     use, 4 hours a week, for the following 2 months. It is hypothesised that using the Tobii™~     Eyegaze System by inpatients with tetraplegia results in improved disability perception and~     independence scores. For the current feasibility study 12 participants will be recruited and~     assessed for 'Appraisal of Disability', 'Mood', 'Assistive Technology perception' and~     'eyeskills' to instruct the computer system. Positive study outcomes will encourage future~     studies of the role of the Tobii™ Eyegaze System in both a rehabilitation and home~     environment.~   "
124060|NCT01943643|"~     This is prospective, observational study, that will be conducted in two high-volume~     university interventional cardiology centers. Study population consists of patients with~     true coronary bifurcations (Medina 1.0.1; 0.1.1; 1.1.1) with >50% stenosis in both main~     (MB) and side branch (SB). Patients are scheduled to undergo percutaneous coronary~     intervention (PCI) based on clinical findings. Before PCI, patients will undergo multislice~     CT angiography (MSCTA). MSCTA before PCI for true non left main bifurcation lesions can~     determine atherosclerotic plaque characteristics in MB and SB and predict significant~     narrowing of SB after provisional stenting. Primary goal is to determine which plaque~     characteristics of true non left main bifurcation lesions in MB and SB, as assessed by~     MSCTA, can affect the occurrence of SB ostial compromise after provisional stenting. Patients~     will be seen in the office visit at 1, 3, 6 and 12 months after the procedure. Clinical~     evaluation and 12-channel ECG are mandatory at each visit. Comprehensive echocardiogram with~     2D-strain analysis will be done at 3-month visit. Repeated coronary angiography will be done~     at 6-month visit, and will include quantitative analysis of previously treated bifurcation~     lesion.~   "
124061|NCT01943630|"~     The purpose of this double blind study is to determine whether topical 15% AS101 gel is~     effective and safe as compared to vehicle in the treatment of external genital warts in~     women.~   "
124062|NCT01943617|"~     Six hundreds patients with chronic hepatitis B clinically diagnosed as compensated liver~     cirrhosis are randomly assigned in a 1:1 ratio. One arm is entecavir alone for 2 years; the~     other is entecavir alone for the first 0.5 year, entecavir plus thymosin-α for 1 year,~     entecavir for another additional 0.5 year.Patients will be assessed at baseline, at every six~     months for blood cell count, liver function test, HBVDNA, AFP, prothrombin time, liver~     ultrasonography, and Fibroscan;~   "
124063|NCT01943604|"~     This study is designed to examine healthy children who skip breakfast and the effects of~     fasting on their neuropsychological functioning and the potential benefits that a Balanced~     Breakfast may have on their learning abilities. It is expected that this study will provide~     new knowledge on how prolonged periods of 8 or more hours without food affect neurocognitive~     processes and thus learning how specific meals following this period of fasting, which most~     children experience, change those processes, potentially for the better.~      The hypotheses for this study are:~        1. Children who consume breakfast will demonstrate significantly higher levels of~          attention, greater concentration, and diminished impulsivity compared to children who do~          not consume breakfast.~        2. Children who consume breakfast will demonstrate a significantly quicker reaction time~          and increased accuracy in correctly identifying target stimuli from an array compared to~          children who do not consume breakfast.~        3. Children who consume breakfast will demonstrate increased freedom from distractibility~          and enhanced short-term memory compared to children who do not consume breakfast.~        4. Children who consume breakfast will demonstrate increased cognitive processing speed~          compared to children who do not consume breakfast.~        5. Children who consume breakfast will have improved verbal learning compared to children~          who do not consume breakfast.~        6. Children who consume breakfast will have improved visual memory compared to children who~          do not consume breakfast.~   "
124094|NCT01943201|"~     Introduction:~      It is known that people with spinal cord injury (SCI) bear a considerably increased risk of~     developing pressure ulcer, whereby frictional forces and shear forces are recognized as risk~     factors. It was the aim of the study to examine the effects of a specially developed~     low-friction hospital bed sheet on skin physiology as well as it's acceptance by patients~     with SCI.~      Method:~      Prospective, randomised crossover study. Patients with a subacute spinal cord injury will be~     recruited. Each patient spends five consecutive nights on the new, respectively, conventional~     bed sheet. After the five nights, patients are asked to complete a linear questionnaire (VAS)~     concerning well-being, odour, perspiration and wrinkling. In addition, the patients are~     examined daily while still fasting, for skin redness, skin moisture, skin elasticity and skin~     blood circulation in the parasacral region.~   "
124064|NCT01943591|"~     Endovascular treatment with platinum coils is safe and effective in preventing rebleeding of~     intracranial aneurysms. Unfortunately, endovascular treatment of aneurysms with coils has~     been associated with incomplete occlusion at initial treatment (remnant) or at follow-up~     (recurrence). This in some studies has been as high as 20%. While many such aneurysm remnants~     or recurrences exhibit benign behavior, many require retreatment to prevent future~     hemorrhage.~      A recent randomized controlled trial of aneurysm coiling revealed that aneurysms between 2~     and 9.9 mm diameter were more likely to have an improved angiographic and composite clinical~     outcome when treated with hydrogel-coated coils, an improvement inferred to result from~     higher packing density afforded by hydrogel expansion(1). The use of hydrogel coils is~     associated with technical difficulties related to expansion and limited time for deployment.~     The investigators theorize that similar results could be achieved by using more voluminous~     bare platinum coils, leading to improved packing density compared to smaller caliber coils,~     and thus result in lower incidence of remnants or residuals. The relationship between packing~     densities and composite clinical endpoints having never been shown in a robust fashion, the~     investigators therefore propose a randomized clinical trial opposing coiling with soft~     15-caliber coils to 10-caliber bare platinum coils in aneurysms varying in size from 3 to 9.9~     mm.~      To test the hypothesis that 15-caliber coiling systems are superior to standard 10-caliber~     coils in achieving better composite outcomes, the investigators propose the DELTA trial: Does~     Embolization with Larger coils lead to better Treatment of Aneurysms trial, a randomized~     controlled blinded trial with 2 subgroups of 282 patients each, 564 total:~      Subgroup 1: Coiled with a maximum proportion of 15-caliber coils as conditions allow Subgroup~     2: Coiled with 10-caliber coils.~   "
124065|NCT01943578|"~     The study examines the physical capacity of lung cancer patients assessed with the six minute~     walk test and handgrip strength. Demographic and selfreported exercise behavior is registered~     to explore correlations to functional and physical capacity.~      Assessments are made before first chemotherapy cycle and after fourth chemotherapy cycle, an~     expected average of 12 weeks between first and second assessment.~   "
124066|NCT01943565|"~     Pain relief after cesarean delivery can be provided in a few ways. Most commonly, certain~     medications called opioids, such as morphine, are given through the vein or into the muscle.~     However, a more effective way to give pain relief with fewer side effects (such as nausea and~     slowing your breathing) is to give opioids in the spinal space as part of the medications~     given for a cesarean delivery.~      For many years, the opioid of choice was morphine due to its long anesthetic effect and~     acceptable side effect profile. A nation-wide disruption in the supply of preservative-free~     morphine has made it necessary to look for alternatives. Many institutions worldwide have~     used another opioid, called hydromorphone, in the spinal space for over a decade. This drug~     has a very good safety and side effect profile and has been used at the investigators'~     institution for more than a year. Of interest, while a number of different doses of~     hydromorphone have been used, there have been very few studies to evaluate the best dose for~     providing good pain relief with minimal side effects. The goal of this study is to find the~     best dose of spinal hydromorphone for women undergoing cesarean delivery.~   "
124067|NCT01943552|"~     This is a randomized, double-blind, placebo-controlled, parallel-group, multi-centre~     trial.The trial aims to evaluate efficacy of nebulized ipratropium bromide in Chinese~     peri-operative patients with COPD under general anaesthesia.~   "
124068|NCT01943539|"~     A study in ADHD and neuro-typical children to assess EVO game play over 29 days.~   "
124069|NCT01943526|"~     The objectives of this study are to assess the long-term safety and impact on disease~     activity and progression of natalizumab (Tysabri) in participants with relapsing remitting~     multiple sclerosis (RRMS) in a clinical practice setting.~   "
124070|NCT01943513|"~     The primary objective of this study is to determine whether muscle atrophy induced by~     immobilization of the lower limb can be attenuated by BIIB023 in healthy male volunteers. The~     secondary objectives of this study in this study population are:~        -  To determine whether muscle weakness induced by immobilization of the lower limb can be~          attenuated by BIIB023~        -  To assess the effect of BIIB023 on the recovery of muscle mass and strength after~          immobilization~        -  To assess the effect of BIIB023 on histological markers of muscle atrophy and~          regeneration~        -  To assess the effect of BIIB023 on muscle bioenergetics based on oxidative metabolism~          recovery kinetics~        -  To evaluate the safety and tolerability of BIIB023~   "
124071|NCT01943500|"~     Objective: To test the sensitivity of a proprietary novel filtration device designed to~     capture and concentrate circulating tumor cells (CTCs).~   "
124072|NCT01943487|"~     This study investigates the effect of the co-administration of verapamil on the steady-state~     pharmacokinetics (PK) of solifenacin succinate and tamsulosin given as a combination tablet,~     EC905.~   "
124073|NCT01943474|"~     The study will test a hypothesis that the AccuCath™ System will have a higher rate of~     successful first attempt peripheral intravenous (IV) placement, higher completion of therapy,~     fewer complications, longer dwell times, and higher user satisfaction compared to~     conventional IV catheters.~   "
124074|NCT01943461|"~     This is a Phase 1, open-label, dose-escalation trial of avelumab (antibody targeting~     programmed death ligand 1 [anti PD-L1]) in Japanese subjects with metastatic or locally~     advanced solid tumors, followed by a consecutive expansion part in Asian subjects with~     gastric cancer.~   "
124075|NCT01943448|"~     Visual impairment in high myopic eyes is mainly due to the different types of myopic~     maculopathies, such as diffuse or patchy atrophy, lacquer cracks and choroidal~     neovascularization. Macular hemorrhage was one of those complications. Despite choroidal~     neovascularization, simple hemorrhage from rupture of Bruch's membrane and choroidal~     microcirculation is also the cause of hemorrhage. The prognosis of those eyes with simple~     hemorrhage is generally good. However, some patients had persistently poor vision after the~     absorption of the hemorrhage. In the literature, the visual prognosis in those patients was~     reported to be associated with the microstructure change under the optical coherent~     tomography (OCT) or the presentation of the autofluorescence. The investigators will collect~     the patients with high myopia and presenting with macular hemorrhage. High resolution OCT and~     autofluorescence imaging will be used to analyze the change of the microstructure of retina~     and its correlation with the visual prognosis.~   "
124095|NCT01943188|"~     This pilot phase I trial studies the side effects and best way to give stereotactic body~     radiation therapy and T-cell infusion in treating patients with metastatic kidney cancer.~     Giving total body irradiation before a T-cell infusion stops the growth of cancer cells by~     stopping them from dividing or killing them. After treatment, stem cells are collected from~     the patient's blood and stored. Chemotherapy is given to prepare the bone marrow for the stem~     cell transplant. The stem cells are then returned to the patient to replace the blood-forming~     cells that were destroyed by the radiation therapy.~   "
124076|NCT01943435|"~     BACKGROUND: Lumbar spinal stenosis - known by patients as arthritis of the spine - is a~     condition that is very common; found in about 30% of older adults. It is the most common~     reason for people over the age of 65 to have back surgery. Some patients with stenosis do not~     need back surgery and can be treated with other methods, such as physical therapy,~     chiropractic, exercise, and medication. But we just don't have enough good research to tell~     us which treatment works best for which patient and under which circumstances. This research~     study hopes to provide more information about the effectiveness of the various non-surgical~     choices for managing stenosis.~      OBJECTIVES: This study will directly compare the effectiveness of three common non-surgical~     treatment approaches for stenosis:~        1. Medical care that involves prescription medications and/or spinal injections (epidurals)~        2. Group exercise in supervised classes given in a community center setting~        3. Hands-on (manual) therapy and rehabilitative exercises given in a clinic setting by~          physical therapists and chiropractors~      METHODS: This research study will involve 259 adults who are at least 60 years old and have~     been diagnosed with lumbar spinal stenosis. The research volunteers will be divided into~     three groups, each group receiving one of the 3 types of treatments listed above under~     Objectives. The determination of which type of treatment each person receives will be~     determined by chance, using a computerized version of flipping a coin. This is a process~     known as randomization, which scientists think reduces the bias in research studies. A series~     of tests and questionnaires will be given to the patients before and after they get treatment~     and comparisons will be made to see how much improvement they made with each of the types of~     treatments. Finally, the researchers will compare the differences between the 3 treatment~     groups to see if certain types of treatment produced better results than others, and if there~     were any examination findings that could be used to predict which type of patient would do~     better with which type of treatment.~   "
124077|NCT01943422|"~     This is a dose-seeking and efficacy study of combined BRAF Inhibitor Vemurafenib and~     High-dose Interferon alfa-2b for therapy of advanced melanoma.~   "
124078|NCT01943409|"~     Intravenous nutrition is an important therapy for the recovery of many patients. It is~     indicated when the patients cannot take food by mouth or use their intestines for feeding. It~     is important to indicate it in the appropriate setting because it's not free of complications~     and is a costly treatment. Some of the complications are: elevated blood sugar or lipids,~     elevated liver function tests, infection of the catheter or device used to administer~     intravenous nutrition. Intravenous nutrition is composed by proteins, lipids, carbohydrates~     (sugar in the form of glucose) and vitamins. Until recently, Intralipid, a soybean oil-based~     lipid emulsion was the only lipid available in Canada for this kind of nutrition. Since 2010,~     a new lipid emulsion (ClinOleic) based on olive-oil has been approved by Health Canada for~     use in intravenous nutrition. There is an increasing need for hospitals to evaluate the~     quality of intravenous nutrition administered to hospitalized patients in terms of: assessing~     indications, prescription, complications, clinical results and costs. The objective of this~     study is to determine if intravenous nutrition prescribed in hospitalized patients is~     indicated following existing guidelines in terms of timing of nutrition support,~     prescription, monitoring and whether it is associated with complications. In addition, length~     of stay and mortality will be assessed. Also, we will evaluate nutritional, infectious and~     inflammatory parameters in patients receiving soybean oil-based lipid emulsion (Intralipid)~     compared to those of patients receiving olive oil-based lipid emulsion (ClinOleic).~   "
124079|NCT01943396|"~     In this research rheohemapheresis will be used for the treatment of patients with high-risk~     dry form of age-related macular degeneration. Correction of rheologic parameters and~     activation of retinal functional reserves after the therapy will positively influence~     functional condition of retina. The newest special electrophysiologic methods will be used to~     determine retinal changes in time. The investigators will also evaluate some important~     immunologic factors and complement changes as well as define indication criteria more~     precisely.~   "
124080|NCT01943383|"~     Patients enrolled in this study will have completed one of the parent studies~     Pharmacogenomic Evaluation of Antihypertensive Responses (PEAR-1 or PEAR-2) evaluating how~     well their blood pressure was controlled by medication. Patients in the current study will~     provide a single tube of blood which will be used to create adult stem cells that can be~     converted into other cell types, like heart or vasculature. Patients will not be asked to~     return for any follow up visits.~   "
124081|NCT01943370|"~     Nasal saline is a common treatment adjunct in the post-operative setting for endoscopic sinus~     surgery. However, the ideal timing and quantity of irrigation in the early post-operative~     period remains unknown. Proposed benefits of early, large volume irrigation include removal~     and softening of crusts, resulting in improved mucociliary clearance. The potential benefit~     of early large volume saline irrigation on post-operative day three to ease or reduce the~     need for early post-operative debridement has not been studied.~   "
124082|NCT01943357|"~     The study will help determine if the Better Choices Better Health Diabetes program~     (community-based or online, also known as the Diabetes Self-Management Program) improves the~     hbA1C of people with Type-II diabetes. The investigators will also examine 1) symptoms~     (fatigue, sleep, low blood sugar symptoms, depression, shortness of breath), 2) healthy~     behaviors (blood sugar monitoring; taking medications as prescribed; getting eye, foot,~     kidney and cholesterol exams; and activity), 3) the use of health care services. This project~     is a translational study to demonstrate the effectiveness of the intervention in the context~     of a major insurer.~   "
124083|NCT01943344|"~     The purpose of this Clinical Investigation is to gather feasibility data on the clinical use~     of the VIVASURE CLOSURE DEVICE™ in relation to safety, and to confirm its performance to~     percutaneously close femoral arterial puncture sites in the range of 18-24 F, post~     endovascular procedures.~   "
124084|NCT01943331|"~     The current protocol desires to implement a large-multicenter observational study of hospital~     acquired infection in ICU in China. The study will generate data on generate data about the~     epidemiology current management of nosocomial infection.~   "
124085|NCT01943318|"~     Liver cirrhosis represents a worldwide health problem and is a major cause of mortality.~     Cirrhosis is the common end for chronic alcohol abuse and hepatitis C and B virus infections.~     Patients who have cirrhosis have varying degrees of compensated liver function, and~     clinicians need to differentiate between those who have stable, compensated cirrhosis and~     those who have decompensated cirrhosis. It is shown various complications: portal~     hypertension, hepatocellular carcinoma, hepato-renal syndrome, etc.~      Thus, it is important to have this information to manage disease and determine specific~     therapy. However, register-based studies in have not been reported in Korea.~      The goal of this study is to describe the natural history of a large number of patients with~     liver cirrhosis prospectively followed, and to identify predictors of the occurrence of~     Hepatocellular carcinoma.~   "
124096|NCT01943175|"~     This study aims at finding endophenotypes of schizophrenia at neuronal level by obtaining~     stem cells which is derived from adipose cells of subjects with heavy genetic loading for~     schizophrenia then differentiating them into neuronal cells.~   "
124086|NCT01943305|"~     Epidemic viral diseases have become more prevalent in recent years. Among the various~     strategies to prevent such epidemics, vaccination is the most cost-effective. However,~     populations that are immunized are typically already exposed to multiple previous~     vaccinations or natural infections. Studies from this and other laboratories have revealed~     that pre-existing dengue antibodies can either inhibit or enhance subsequent dengue infection~     depending on the pre-existing antibody levels. While cross-reactive antibody is potentially~     pathogenic in dengue, how it impacts immune response to vaccination is unclear. Indeed,~     aggregated at the site of vaccination and the respective draining lymph nodes are~     antigen-presenting and immune regulatory cells that express Fc receptors and play pivotal~     roles in determining the magnitude and polarity of the immune response. Vaccine uptake by~     these antigen-presenting cells may thus be either inhibited or enhanced when vaccines are~     opsonized with cross-reactive antibodies.~      In view of the limited knowledge on how cross-reactive antibodies affect vaccination outcome,~     investigators propose here a study that exploits the known cross reactivity between Japanese~     encephalitis (JE) virus antibody and yellow fever (YF) vaccine. Investigators hypothesize~     that cross-reactive antibodies impacts antibody response to YF at the point vaccination in a~     concentration-dependent manner by altering both vaccine uptake and the innate immune response~     by antigen presenting cells. Investigators will structure an open label clinical trial on~     sequential vaccination with JE and YF vaccines, with different time intervals between~     vaccinations. This would test immune response to YF vaccination in subjects with different~     titer of cross-reactive JE vaccine-derived antibodies.~   "
124087|NCT01943292|"~     This is a phase I, open-label, dose-escalation trial of defactinib (VS-6063), a focal~     adhesion kinase inhibitor, in Japanese patients with non-hematologic malignancies. The~     purpose of this study is to assess the safety (including the recommended phase 2 dose), the~     pharmacokinetics, and the anti-cancer activity of defactinib (VS-6063).~   "
124088|NCT01943279|"~     Background: Medical abortions in Canada are provided using a standard regimen of methotrexate~     and misoprostol. After these medications are administered, patients are most commonly checked~     for termination of the pregnancy with an ultrasound and physical examination at an in-clinic~     follow-up appointment. These follow-up appointments can be inconvenient, costly, and take~     away from patient privacy. Furthermore, it has been suggested that these follow-up~     appointments may not be necessary for patients.~      Objective: To determine whether remote follow-up, using telephone and blood testing is a~     feasible, safe, and effective method of follow‐up after medical abortion, compared to~     standard care that requires an in-clinic visit and ultrasound.~      This study offers women the option of remote follow-up by telephone combined with serum~     Beta-human chorionic gonadotropin (β-hCG) testing or standard in-clinic follow up. We will~     determine women's preferences for follow up, and compare adherence to the follow-up schedule,~     number of clinical contacts, and outcomes of the abortion. This study will be performed at~     two clinics in Toronto, the Bay Centre for Birth Control (BCBC) and the Choice in Health~     Clinic (CIHC).~      Primary Hypothesis: Follow-up will be more successful with RFU, compared to SFU.~   "
124089|NCT01943266|"~     Minimal data are available on protein requirements throughout the lifespan. Currently~     available recommendations are based on nitrogen balance data. The limitations of the nitrogen~     balance method have been well described. Importantly, nitrogen balanced underestimates~     requirements.~      The current dietary reference intakes (DRI) requirement for healthy adult males is based on~     the reanalysis of the nitrogen balance date from Young and Scrimshaw. This data was~     reanalyzed statistically by Rand et al. and he concluded that the protein requirement of~     healthy adults was 0.65 and 0.83 (mean and RDA) g/kg/day of good quality protein. Using~     indicator amino acid oxidation (IAAO), our group estimated the protein requirement of young~     men (mean age 27 years) to be 0.93 and 1.2 g/kg/day (mean and RDA).~      Currently there are no studies on protein requirement in the elderly. In a recent nutrition~     survey conducted by national health and nutrition examination survey (NHANES), the authors~     concluded that adults between the ages of 51 - 70 years old consumed an average on 1.0~     g/kg/day (ideal body weight) of protein which represents about 15 % of calories. Depending on~     the calculations used for ideal body weight some older adults could be getting higher or~     lower than requirement. There is no scientifically derived protein estimate for older adults.~     Therefore there is a need to measurer protein requirement in that population.~      The goal of this study therefore is to measure the protein requirement of male elderly~     subjects between the ages of 65 - 75 years using the IAAO technique.~   "
124090|NCT01943253|"~     1. Introduction The aim of the study is to evaluate the efficacy and safety of ESD by use~          of a new water-jet assisted ESD system using the HybridKnife® in patients with early~          gastric neoplastic lesions in comparison to the conventional ESD established in Japan.~          The water-assisted ESD technology allows pressure controlled injection of fluids through~          the tip of a recently developed HybridKnife®. Submucosal injection, circumferential~          cutting and dissection of lesions as well as coagulation of bleeding can be performed~          with the same device without need for changing the instrument. These options should~          accelerate the procedure and may increase its safety and efficacy.~        2. Hypothesis The water-jet assisted ESD technique using the HybridKnife® bears the~          advantage of less instrument changes due to the combination of high-frequency cutting~          and water-jet application in one single instrument. This should lead to a simplified ESD~          procedure, shorter learn-ing curve and especially to a shorter procedure time.~      The water-jet assisted ESD technique should be shorter than the conventional ESD techniques~     using IT2-, Dual- and Hook-Knifes at least with the same safety and effectiveness.~   "
124091|NCT01943240|"~     Our routine practice for patients undergoing mastectomy is to include paravertebral~     peripheral nerve blockade for postoperative analgesia. This study investigates whether the~     addition of another nerve block targeting the pectoral nerves will improve that analgesia.~   "
124092|NCT01943227|"~     This is a single site, prospective, non-blinded, non-randomized, non-interventional study~     designed to evaluate the effect of changes in alveolar minute ventilation on the measurement~     of respiratory heat loss (enthalpy).~   "
124093|NCT01943214|"~     By analyzing the relationship between the body constitution and the progression of Type II~     diabetes mellitus, its morbidities, mortality and the impact of the life quality, we try to~     provide an useful tool, body constitution, to stratify the patients accordingly for~     individualized health care.~   "
124098|NCT01943149|"~     The purpose of this study is to monitor outcomes of total hip arthroplasties performed with~     E-MAX polyethylene and BIOLOX Delta Ceramic head. Polyethylene has been used as a bearing~     surface in total joint replacements for half of a century. Radiation, the most common form of~     sterilization, unfortunately it results in the creation of free radicals (atoms or molecules~     that cause chemical reactions with other substances) within the materials which cause the~     breakdown of the polyethylene. Second generation antioxidant polyethylene, Renovis E-MAX,~     mechanically blends in Vitamin E as an antioxidant. This helps eliminate free radicals while~     maintaining mechanical strength. The theory is that E-MAX will be a safe and long lasting~     bearing surface in total hip arthroplasty that meets or exceeds current wear rates after~     being placed in a patient.~   "
124099|NCT01943136|"~     This study will be an investigator-blinded, patient-blinded, assessor-blinded,~     parallel-group, randomized clinical trial. It aims to evaluate the efficacy of one-week~     twice-daily application of topical papaya leaf extract ointment compared to mupirocin~     ointment in achieving clinical cure among patients with impetigo.~   "
124100|NCT01943123|"~     This study was conducted to assess the effects of commercially available probiotic drink on~     the number of salivary mutans streptococci in school going children, aged 12-14 years in~     Bangalore city in India~   "
124101|NCT01943110|"~     The purpose of this study is to evaluate whether two intradermal (ID) vaccine delivery~     devices can safely and precisely inject liquid into the intradermal layer of the skin in~     three different injection locations~   "
124102|NCT01943097|"~     Neuroblastic tumors are childhood neoplasms that possess amino acid decarboxylase (AADC)~     activity and Meta-iodobenzylguanidine(MIBG), they can theoretically be imaged by~     (18)F-fluorodihydroxyphenylalanine ((18)F-FDOPA) and~     (123)I-Meta-iodobenzylguanidine((123)I-MIBG) PET, they are new and specific diagnostic and~     follow-up tools for neuroendocrine tumors. In this study, we explored the accuracy and~     clinical role of (18)F-FDOPA and (123)I-MIBG PET in neuroblastic tumors.~      METHODS:~      Patients with tissue-proven neuroblastic tumors receiving (18)F-FDOPA PET or (123)I-MIBG at~     initial diagnosis or during follow-ups were enrolled. The sensitivity and specificity of~     (18)F-FDOPA or (123)I-MIBG PET were compared to each other and compared to(18)F-FDG PET,~     using tumor histology as the standard.~   "
124103|NCT01943084|"~     This trial is conducted in the United States of America (USA). The aim of the trial is to~     investigate the bioequivalence (the expected biological equivalence of two pharmaceutical~     drug products with identical active ingredient) of Norditropin® (somatropin) versus~     Genotropin® (somatropin) in healthy adult subjects.~   "
124104|NCT01943071|"~     Attending day care centres with programs specifically designed for patients with dementia is~     believed to postpone admittance to nursing home as well as increase quality of life and~     well-being for both patients and their family caregivers. We aim to investigate to what~     degree attendance in day care centres with programs for people with dementia is effective for~     patient and their caregivers whilst also cost efficient for society. The study consists of a~     quasi-experimental trial with comparison group. 400 patients with dementia, along with a~     family caregiver, will be included in the trial. Effects will be measured at baseline, after~     one and two years. Data collection will be made at three levels; at patient level with~     measures of cognition, depression, quality of life, functioning in activities in daily~     living, neuropsychiatric symptoms and death; at caregiver level with measures of depression,~     level of burden and quality of life; and at societal level with measures of nursing home~     admittance, hospital stays and use of other health resources. Additionally,a qualitative~     interview study will include 20 dyads from the main trial. The main focus will be on how~     attending day care centre programs for patients with dementia affect the lives of both~     patients and caregivers. Five of these dyads will be followed closely throughout the~     participation period to be used as case examples.~   "
124105|NCT01943058|"~     This randomized phase II trial studies how well megestrol acetate or levonorgestrel-releasing~     intrauterine system works in treating patients with atypical endometrial hyperplasia or~     endometrial cancer. Progesterone can cause the growth of endometrial cancer cells. Hormone~     therapy using megestrol acetate or levonorgestrel-releasing intrauterine system may fight~     endometrial cancer by lowering the amount of progesterone the body makes. It is not yet known~     whether megestrol acetate is more effective than levonorgestrel-releasing intrauterine system~     in treating atypical endometrial hyperplasia or endometrial cancer.~   "
124106|NCT01943045|"~     The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in~     patients with Type 2 Diabetes.~   "
124107|NCT01943032|"~     The purpose of this study is to determine discordant hormonal status of primary breast tumor~     and metastatic breast cancer cells at regional lymph nodes in node positive breast cancer~     patients.~   "
124108|NCT01943019|"~     Approximately one third of patients with schizophrenia show a poor response to standard~     treatment with antipsychotic medications. This treatment resistant group of patients~     represents a major challenge in everyday psychiatry, and consumes a disproportionate amount~     of time from the clinicians, resulting in considerable costs to the society and government.~     Anecdotal evidence suggests that the enzyme dipeptidyl peptidase IV (DPPIV) may be altered in~     patients with schizophrenia, with a higher level DPPIV enzyme activity being noted. We~     postulate that this may play a role in the neuropathology of schizophrenia patients and by~     inhibiting the DPPIV enzyme activity with a DPPIV inhibitor such as linagliptin, we will be~     able to improve and even ameliorate the symptoms of schizophrenic patients. However, until~     now there have yet any studies on the potential of these inhibitors in schizophrenia~     patients. A pilot study is thus proposed to evaluate the potential of the DPPIV inhibitor,~     linagliptin as an adjunct in schizophrenia patients who are non-responsive to treatment,~     which will establish the feasibility of a larger trial.~   "
124109|NCT01943006|"~     Patients receiving nutritional emulsion for at least 3 days will be treated with Hirudoid~     cream or placebo cream to prevent and treat phlebitis caused by the infusion. The treatment~     is continued after the end of infusion for at least 7 days.~      Number of patients developing superficial phlebitis and duration of phlebitis will be~     recorded.~   "
124133|NCT01942694|"~     The goal of the Vitamin D and type 2 diabetes (D2d) study is to determine if vitamin D~     supplementation works to delay the onset of type 2 diabetes in people at risk for the disease~     and to gain a better understand how vitamin D affects glucose (sugar) metabolism.~   "
124110|NCT01942993|"~     Approximately 40-60 % of cutaneous melanomas select for a mutation in a protein called BRAF~     which is part of a signaling pathway called the Mitogen Activated Protein Kinase (MAPK)~     pathway. When BRAF is mutated the MAPK pathway remains active allowing for melanoma to grow.~     Vemurafenib is an oral treatment which blocks the activity of BRAF which leads to decreasing~     the activity of the MAPK pathway. When patients with melanoma expressing specific mutation in~     BRAF are treated with vemurafenib approximately 50% will develop a response to treatment with~     shrinkage of tumor. When compared to a standard chemotherapy called dacarbazine used to treat~     melanoma, treatment with vemurafenib leads to a statistically significant overall survival or~     living longer benefit. Because of this survival benefit vemurafenib was Food and Drug~     Administration (FDA) approved for the treatment of metastatic melanoma expressing a BRAF~     mutation called V600E BRAF. There is increasing evidence that the immune system can also be~     important in affecting melanoma growth and survival and there are immune treatments FDA~     approved for the treatment of metastatic melanoma. There is some limited evidence that~     blocking BRAF with vemurafenib may affect the activity of components of the immune system. It~     is important to better characterize and understand the effects of vemurafenib treatment on~     various components of the immune system. The purpose of this study is to systematically~     evaluate the effects of vemurafenib treatment (at FDA approved dosing regimen) on parts of~     the immune systems called the innate and adaptive immune systems. The hypothesis is that~     vemurafenib treatment will affect the immune system.~   "
124111|NCT01942980|"~     The incidence of brain metastases (BM) in metastatic breast cancer is increasing, due to the~     improvement in the control of systemic disease, and due to an improved detection through~     imagery.~      The treatment management of single BM remains controversial. Indeed, even though it is widely~     accepted that local treatment increases the median survival time in patients having a good~     prognostic status, the adding of adjuvant whole-brain radiation therapy (WBRT) is currently~     subject to controversy, due to its potential toxicity. Yet, two randomized trials have~     demonstrated a clear increase in intra-cerebral recurrence and in death from neurologic~     origin in case of absence of adjuvant WBRT, without change in overall survival (but overall~     survival was not a primary endpoint in any of these studies).~      The data from literature on cognitive toxicity (CT) of WBRT on BM are scarce and sometimes~     controversial. CT of WBRT affects the subcortical frontal functions. It is postulated that~     the alteration of hippocampal neurogenesis (mainly due to inflammation process), situated in~     the subgranular zone of the dentate gyrus, has an essential role in the development of these~     brain dysfunctions.~      It has been shown that the incidence of BM in the hippocampal region (hippocampus + 5mm~     expansion) is low, in the range of 8,6%.~      New irradiation techniques, in particular intensity-modulated radiotherapy associated with~     rotational radiotherapy, allow to modulate the dose on an intra-cerebral structure, all the~     while distributing an adapted dose to the remaining brain.~      This prospective, randomized study, will compare, through a battery of neuropsychological~     tests, the cognitive impact of WBRT of 40 Gy in 20 fractions with or without hippocampal~     avoidance by intensity modulated radiotherapy, in patients presenting with a single operated~     brain metastasis of breast cancer. If the hippocampal avoidance leads to a significant~     improvement in cognitive function, this radiotherapy scheme could become the standard~     postoperative treatment to be proposed to patients presenting the best prognostic factors.~     This would allow to prevent long-term cognitive deficit, while preserving WBRT benefit on~     intra-cerebral control.~      Justification of evaluation criteria :~      Principal criteria :~      Evaluation criteria to assess cognitive toxicity have been selected on the basis of the~     recommendations from C. Meyers and P. Brown, who propose an adapted test battery to evaluate~     memory, verbal function, visual and motor coordination, and executive function. The selected~     tests have been validated, also in French. They comprise HVLT-R (Hopkins Verbal Learning Test~     Revised), COWAT (Controlled Oral Word Association Test), Grooved Pegboard test, TMT A and B~     (Trailmaking tests A and B), and MMSE. The calculation of patient numbers was based on the~     HVLT-R test, as memory is thought to be the most frequently affected domain.~      The tests will be performed before treatment (baseline cognitive function), at 4 months and~     at 12 months. In case of a missing answer to the evaluation tests, the reason(s) for not~     answering will be noted.~      Secondary criteria :~      Quality of life : QLQ-C30, QLQ-BN20, ADL, IADL Intra-cerebral Progression-free survival (PFS)~     Overall survival.~   "
124112|NCT01942967|"~     The purpose of this study is to examine the blood flow and the delivery of oxygen to the~     brain and gut in preterm babies while they are supported with two modes of breathing machine~     and compare these two methods to see if one allows for better blood flow to the brain and~     gut.~   "
124113|NCT01942954|"~     The consequences of alcohol dependence are severe and may range from physical diseases to~     neuropsychological deficits in several cognitive domains. Alcohol abuse has also been related~     to brain dysfunction specifically in the prefrontal cortex. To assess these deficits and the~     application of a novel approach of cognitive stimulation to alcoholics, we have carried out a~     neuropsychological intervention program with mobile health technology. Patients diagnosed~     with alcohol dependence syndrome were submitted to cognitive stimulation during four weeks in~     a three-day/week basis.~   "
124114|NCT01942941|"~     A study to see what effect the geko™ device has on blood flow in patients with lower limb~     vascular disease.~   "
124115|NCT01942928|"~     Background Excessive Crying (Infantile Colic) is one of the most common complaints for which~     parents seek treatment. These otherwise healthy and well fed infants show no signs of failure~     to thrive, cry without identifiable cause, fuss a lot and are hard-to-soothe.~      Objective To explore the feasibility of running a Randomised Controlled Trial (RCT) that~     investigates the effectiveness of cranial osteopathy in addition to usual National Health~     Service (NHS) care in infants with colic.~      Methods Pragmatic randomised controlled trial, involving United Kingdom (UK) osteopaths in~     private practice and NHS health visitors. Parents of 60 excessively crying infants/infants~     with colic will be recruited by NHS health visitors. Infants will be included into the study~     if they are healthy (full-term) and aged 1-7 weeks, diagnosed with excessive crying/infantile~     colic, and have no co-morbidities. Participants will be randomised into the usual NHS care~     group or the usual NHS care plus cranial osteopathic intervention group.~      Usual NHS care will be provided by health visitors and osteopathic treatment will be carried~     out by experienced osteopaths in private practice.~      Primary outcome measures are acceptability and feasibility of intervention procedures.~     Furthermore, changes in the frequency and duration of crying will be documented in a daily~     crying diary. Parental quality of life will also be assessed.~      This pilot investigation will provide useful information in order to further develop and~     adapt the current interventions and trial procedures with a view to a full-scale randomised~     controlled trial.~   "
124116|NCT01942915|"~     This study is to evaluate the safety and efficacy of umbilical cord blood mononuclear cells~     transplantation in liver cirrhosis patients.~   "
124117|NCT01942902|"~     The purpose of this study is to evaluate the system performance of the GlySure Continuous~     Glucose Monitoring (CGM) system in patients admitted to the Surgical Intensive Care Unit.~   "
124118|NCT01942889|"~     On the basis of published data and investigators results indicating that systemic redox in~     balance may contribute to the peripheral muscle dysfunction in COPD patients, the~     investigators propose a study testing the effects of antioxidants and exercise training in~     COPD patients. The results may have major implication in the improvement of pulmonary~     rehabilitation benefits~   "
124119|NCT01942876|"~     The proposed study will address the critical need to reduce illegal drug use, in particular~     drug use, and the occurrence of drug-related harm in low-income racially diverse patient~     populations at urban primary care safety-net clinics. Since they are at risk for accelerated~     trajectories to drug dependence once drug use begins, low-income racially diverse populations~     pose particular concern for public health policy makers and drug-use prevention efforts. The~     study will be the first to standardize drug screening and primary-care clinician delivered~     brief intervention among racially diverse at risk drug users, that is users with casual or~     frequent use without the physiological or psychological manifestations of dependence, to~     reduce their 'at risk' use of drugs, and it may effectively interrupt their pathway to~     dependence.~   "
124134|NCT01942681|"~     This study is to evaluate the efficacy and safety that the occurrence of incontinence is~     significantly decrease using the propiverine hydrochloride for 200 female patients with mixed~     (stress and urge) urinary incontinence in one week during a twelve-week treatment period.~   "
124135|NCT01942668|"~     This study will be a prospective, randomized, double-blind, placebo-controlled, parallel~     group, multicenter trial of postmenopausal subjects with an intact uterus.~   "
124171|NCT01942200|"~     The main purpose of this observational study with Oxaliplatin onkovis is to determine the~     number of treatment cycles and the quantity of Oxaliplatin onkovis needed for this purpose~     under the special circumstances of ambulant chemotherapy.~      Onkovis aims to contribute to an economical utilization of the chemotherapeutics. This~     includes provision of appropriate packaging sizes to decrease the excess quantity to be~     discarded, and thus also follows this objective.~      Secondary objective is the assessment of the side effects of Oxaliplatin onkovis. To this~     end, data regarding co-medication and adverse events are also collected.~   "
124120|NCT01942863|"~     Enteroscopy, including double balloon enteroscopy (DBE), single balloon enteroscopy (SBE) and~     spiral enteroscopy (SE) currently, have shown good performances in small bowel diagnostics~     and seem to be useful in the clinical routine. However, enteroscopy is a time-consuming~     procedure. During common practice, large volumes of air need to be insufflated for good~     visualization. It leads to significant distention of the small bowel during the examination,~     which makes further intubation more technically challenging because of the formation of~     distended bowel loops and acute angulations and limits the maximal intubation length.~     According to the published data, the oral insertion depth of different kinds of enteroscopy~     is limited to approximately 240 cm. The total examination rate range form 18% to 86% for DBE~     and 0% to 11% for SBE.~      It is thought that the intubation depth in small bowel determines the diagnostic yield and~     the following treatment. The deeper the enteroscopy is advanced into the small bowel, the~     more lesions may be found and treated. In order to improve the intubation depth of balloon~     enteroscopy, several methods, such as carbon dioxide insufflation and decompression side~     tube-equipped device, have been tried and showed positive effects. CO2 insufflation could~     also reduce severe pain during DBE and residual gas retention after the procedure because of~     rapid absorption. However, it is not known how much CO2 insufflation can decrease the~     distention of small bowel and the formation of bowel loops.~      Recently, the use of water infusion in lieu of air insufflation has been shown to facilitate~     completion of colonoscopy, even in potentially difficult patients with prior abdominal or~     pelvic surgery. Water exchange method obviates excessive lengthening of the colon and the~     formation of acute angulation, which may cause less pain and easier intubation during scope~     insertion. Recently, water exchange method was also tried in two patients undergoing SBE via~     antegrade route in our center. Distal ileum 8cm near to ICV and the cecum was reached~     respectively (unpublished data), indicating water exchange be a useful method for deep~     intubation of SBE.~      Here a prospective, randomized, controlled trial was designed to investigate whether,~     compared with CO2 insufflation method, water exchange method could increase the intubation~     depth and diagnostic yield in patients undergoing SBE.~   "
124121|NCT01942850|"~     The project will collect information on the mapping of clinical ratings on a number of scales~     that are used in the assessment of patients with ataxias.~   "
124122|NCT01942837|"~     This research study is evaluating a drug called enzalutamide in metastatatic castration~     resistant prostate cancer.Enzalutamide is already FDA approved for metastatic castration~     resistant prostate cancer after treatment with chemotherapy. The purpose of this study is to~     analyze features of tumor specimens sampled prior to therapy and at disease progression to~     determine why patients respond or stop responding to treatment with Enzalutamide. Prior~     chemotherapy is not a requirement of this trial. Enzalutamide is a drug designed to block the~     effects of male hormones in the body that may be helping prostate cancer to grow. It has~     already been approved by the FDA (the U.S. Food and Drug Administration) for patients with~     castration-resistant prostate cancer who have received prior chemotherapy.~      Additionally, this study will analyze features of tumor specimens sampled prior to therapy~     and at disease progression to determine why patients respond or stop responding to treatment~     with enzalutamide.~   "
124123|NCT01942824|"~     Influenza infection leads to on average 24,0000 deaths and 150,000 hospitalizations annually.~     While vaccination is the cornerstone of preventing influenza infection, vaccination coverage~     in adults is low with only 35% vaccinated by end of November. Latino adults have the lowest~     coverage rates. Text message reminders have been used successfully for improving influenza~     vaccination for children. This study will assess the use of text messaging to improve~     influenza vaccination coverage rates in a largely minority, publicly insured adult~     population.~   "
124124|NCT01942811|"~     The goal of the US-Mexico Binational Quit Using Drugs Intervention Trial (QUIT) is a~     multi-site study conducted in the US (East Los Angeles) and Mexico (Tijuana) which aims to~     reduce drug demand on both sides of the border. The study also aims to build a collaborative~     partnership between the US and Mexico research teams. The Bi-National QUIT Study will conduct~     a randomized control trial for risky drug use in several Los Angeles area community health~     centers. The intent of the trial is to interrupt the progression to addiction for the casual~     and occasional users of illicit drugs and non-medical users of pharmaceuticals. The~     Bi-National QUIT protocol will include (1) a computerized assessment of the patient's~     drug-use history (2) very brief (<5 minutes) clinician advice during a patients pre-arranged~     medical visit which will be preceded by a computerized assessment of the patient's drug-use~     history (3) a post visit assessment and video doctor (repeating the very brief clinician~     advice) in the waiting room (4) two post-visit telephone drug-use counseling sessions to be~     conducted by drug-health educators at approximately 2 and 6 weeks after the start of the~     intervention. Follow-up assessments will be conducted at 3 months post-randomization.~     Parallel activities will take place in the U.S./Los Angeles sites and Mexico/Tijuana sites.~     Data will be shared between both teams. Data analysis will be collaboratively conducted by~     both teams.~   "
124125|NCT01942798|"~     WiiNWALK is a 4 week physical activity, with the intervention of a WiiFit, targeted to~     improve walking capacity in individuals with either a unilateral below-knee or above-knee~     amputation. This is a randomized control trial to evaluate the effectiveness of the WiiNWALK~     program in older (50+ years) community living adults with lower limb amputations (LLA).~      Hypothesis: We expect the WiiNWALK intervention will have a treatment effect with improvement~     in functional walking capacity, compared to the control group who will only be playing~     cognitive games. Secondarily, a functional walking capacity will also include an improvement~     in lower extremity strength and balance, inter-limb gait symmetry, balance confidence along~     with participation in daily and social activities, locomotor capabilities and an increase in~     physical activities.~   "
124126|NCT01942785|"~     To explore the anti-impulsive and anti-aggressive properties of brexpiprazole in a~     naturalistic setting of depressed patients with irritability.~   "
124127|NCT01942772|"~     Ankle rehabilitation training becomes a tough question for the patients with ankle joint~     injuries especially with the hemiplegia after stroke. Here a novel powered ankle foot~     orthoses which can provide ankle dorsiflexion and plantar flexion assistant using electric~     motor is proposed in this paper. The mechanical structure of the orthoses includes wearing~     parts, ankle joint hinged part, driving unit, transmission mechanism and sensing units. This~     study provides a new method for ankle foot orthoses design and has great significance for~     ankle rehabilitation.~   "
124128|NCT01942759|"~     The purpose of this study is to determine findings of positron emission tomography and~     diffusion weighted magnetic resonance in primary lesion and axillary metastasis of breast~     cancer and compare of two imaging modality in these patients.~   "
124129|NCT01942746|"~     Clinical evidence for effects of plant anthocyanins on vision, and particularly night vision~     is controversial. Two clinical trials were conducted to investigate whether blueberry juice~     consumption affected visual dark adaptation, functional night vision, and recovery after~     photo-bleaching of the retina. One trial (S2) employed a 3 week intervention and washout~     period, and two doses of blueberries plus a placebo. The other trial (L1) employed a 12 week~     intervention plus an 8 week washout and tested one blueberry juice dose against a juice~     placebo.~   "
124136|NCT01942655|"~     Progressive HIV or HIV infection seems to be related to a preferential loss of CD4+ T~     lymphocytes, especially Th17+, within the mucosal intestinal lymphoid tissue, and with~     intestinal mucosal damage and bacterial product translocation, which correlates with the~     hyperactivation of the immune system, therefore with CD4+ T cell loss and prognosis. The~     objectives of this project are to investigate the correlation between the IL12/IL-23~     imbalance and bacterial product translocation, and to study the polarization, infection or~     depletion of intestinal Th17 ex vivo. The investigators will test the effect of neutralizing~     anti-IL23 antibodies directed against p40, or less classically, anti- IL-23 p19.~   "
124137|NCT01942642|"~     Meibomian gland dysfunction (MGD) is a common and important disease has been investigated the~     pathophysiology, diagnosis, treatment modalities of MGD, however, the changes of MGD after~     the cataract surgery, the most popular surgery to ophthalmologist, had not been evaluated.~     The investigators evaluated parameters related with MGD including lid margin abnormalities,~     meibomian gland expressibility and meibography before and after surgery.~   "
124138|NCT01942629|"~     The p63 gene is a recently discovered member of the p53 family located at chromosome 3q27Many~     studies have reported that overexpression of p63 can mimic p53 activities by binding DNA,~     activating transcription, and inducing apoptosis.~      Various studies proved p63 as a marker of basal cells in normal salivary glands, breast,~     prostate, respiratory and squamous epithelia, and of tumor cells from various malignancies.~     Still, p63 has been the subject of relatively few studies in lung adenocarcinoma, and breast~     carcinoma, and no study has described the correlation of p63 with pancreatic ductal~     adenocarcinoma.~      In the current study, we aim to evaluate the prognostic value of the expression of p63 in the~     lung adenocarcinoma, breast adenocarcinoma, and pancreatic ductal adenocarcinoma. We will~     achieve this aim by collecting clinical data retrospectively from the patients' medical~     records as well as assessing the histological sections and performing immunohistochemical~     staining for p63.~   "
124139|NCT01942616|"~     We propose an experimental design to empirically establish the potential link between the~     media portrayal of DV and changes in an individual's DV descriptive and injunctive social~     norms. Specifically, this study will measure the degree to which people implicitly collude~     with DV perpetration.~   "
124140|NCT01942603|"~     The purpose of this registry is to collect data in order to discover whether melanoma~     patients with minimal SN tumor burden should undergo a complete lymph node dissection (CLND)~     or not.~      Currently, if a patient has a positive (or metastatic) SN, this patient will be offered a~     CLND, which is a surgical intervention aiming to remove all lymph nodes from the same nodal~     basin as the SN. However, if the positive (or metastatic) SN is only minimally involved, some~     centers and/or countries do not offer a CLND routinely. As a matter of fact, the CLND~     procedure does not increase survival for patients with a minimal SN tumor burden, but can add~     prognostic information, potentially useful in the subsequent decision-making process.~     However, this is a surgical operation for the patient, which might be accompanied by~     significant side effects. Moreover, only approximately 20% of patients with a metastatic SN~     have further lymph node metastases in the same basin, which means that about 4 patients out~     of 5 will not benefit from a CLND. Thus, there is an urgent need to identify which SN~     positive patients could be safely spared from a CLND. It has been demonstrated that breast~     cancer patients with minimal SN tumor burden can be safely managed with nodal observation~     only, without performing a CLND. There is evidence that the same situation exists in melanoma~     as well, but this needs to be validated and this is why we are conducting this registry.~      The results of this registry will be crucial to establish an accepted standard of care (CLND~     or nodal observation) for melanoma patients with minimal SN tumor burden.~   "
124141|NCT01942590|"~     Funding Source- FDA OOPD~      The purpose of this study is to investigate the safety and efficacy of clenbuterol on motor~     function in individuals with late-onset Pompe disease (LOPD) who are treated with enzyme~     replacement therapy (ERT).~   "
124142|NCT01942577|"~     The skin and intestinal tracts of humans are covered with microbes, and the gene products of~     these microbes are collectively known as the human microbiome. Many studies in recent years~     have linked the microbiome to many aspects of human health and disease. Premature infants are~     vulnerable to invasive infections, some of which may originate from the microbes that~     colonize the skin and in the intestinal tract. Therefore, determining the patterns of early~     life colonization and the sources of colonization in these infants may be critical to~     determining infectious risks. This prospective study is proposed to identify the sources of~     microbes that colonize extremely low birth weight (ELBW; <1000 g birth weight) infants~     immediately following birth through the first month of life. The study team plans to~     non-invasively survey the skin and stool of ELBW preterm infants in combination with sampling~     of their mothers' skin and stool and the intensive care nursery (ICN) environment. As~     controls, the study team will perform a similar survey of full term mother-infant pairs.~     Samples will be analyzed using high throughput sequencing techniques to determine microbial~     content.~      Topical barrier sprays or emollients are commonly used early in life in the ELBW infant to~     reduce insensible water loss and enhance the integrity of the skin barrier. The effect of~     these treatments on the development of the skin microbiome remains unknown. As part of this~     study, the study team also proposes the application of two different skin barrier therapies~     to small areas on infant's legs to determine the effects of the different treatments on skin~     colonization. While all parts of the study are described in this summary and the detailed~     description, the remainder of the record focuses on this interventional portion of the study~     (Group 2).~      The goals of this study are outlined as follows:~        1. To elucidate the relationship between microbes in the health care environment and~          colonization patterns of the intestinal tracts in preterm and term infants.~        2. To understand the relationship between mode of delivery, the health care environment,~          and the colonization of the skin in preterm and term infants.~        3. To determine the effects of topical skin barrier therapies on the colonization patterns~          of the skin in preterm infants.~        4. To ascertain the relationship between the composition of the microbes colonizing preterm~          and term infants and the development of mucosal and systemic immunity to those microbes.~   "
124143|NCT01942564|"~     After a head injury, many people find that exposure to light causes them increased~     discomfort. By measuring how the pupil in the eye constricts to flashes of red and blue~     light, this study will investigate whether this phenomenon is due to a change in the eye's~     sensitivity to light.~   "
124144|NCT01942551|"~     This is an open-label, two-arm, one-sequence, cross-over study to evaluate the safety and~     pharmacokinetic interaction after oral concomitant administration of tadalafil and~     dutasteride in healthy male volunteers.~   "
124145|NCT01942538|"~     Maintenance rTMS sessions after a successful 3week-rTMS treatment for subjects with~     fibromyalgia may maintain the clinical improvement.~   "
124169|NCT01942226|"~     Dry eye is a common complaint in patients encountered by ophthalmologists, which may result~     from the inflammatory response and can occur in the absence of systemic disease. However, the~     management of dry eye syndrome in real setting warrants assessment but remains lacking in~     Taiwan. We conducted an perspective observational study to evaluate the medical management of~     dry eye patients.~   "
134195|NCT01810796|"~     Working hypothesis and aims: 1) To explore the pathophysiology of postoperative troponin~     elevations and 2) whether ranolazine, a new anti-ischemic drug that has no effect on blood~     pressure or heart rate, prevents postoperative myocardial injury.~   "
124146|NCT01942525|"~     Objective: The impact of intrauterine growth restriction (IUGR) on perinatal morbidity and~     long-term neurodevelopmental outcome has been published in numerous studies. Throughout this~     analysis, the influence of IUGR on the postnatal amplitude-integrated EEG (aEEG) in preterm~     infants below 30 weeks of gestation was assessed. The second concern was the correlation~     between the pattern of the aEEG in the first two weeks with neurodevelopmental outcome,~     comparing infants with and without IUGR.~      Methods: Routinely assessed aEEG data of preterm infants with IUGR born below 30 weeks of~     gestation in the years 2005 until 2007 were analysed retrospectively according to the aEEG~     score (combining occurrence of sleep-wake-cycles, background activity and suspected seizure~     activity). Neurodevelopmental outcome was evaluated at 24 months using the Bayley Scales of~     Infant Development and standardized neurologic examination.~   "
124147|NCT01942512|"~     Endovascular treatment is now the first line treatment for the management of intracranial~     aneurysms. However aneurysm recanalization is an important limitation to this treatment.~     Several factors seems to be associated with aneurysm recanalization including medical history~     of the patient, aneurysm status (ruptured or unruptured), aneurysm size and location,~     modalities of treatment, immediate post-operative occlusion of the aneurysm.~      A precise knowledge of factors increasing the risk of aneurysm recanalization is quite~     important to optimize strategy of treatment and reduce the recanalization rate. No large,~     prospective, multicenter trial dealing with this question has been published in the~     literature.~   "
124148|NCT01942499|"~     It is well established that individuals living with chronic obstructive pulmonary disease~     (COPD) demonstrate significant improvements following a formal rehabilitation program. The~     problem lies in the fact that these functional improvements diminish over a 12 month period.~     This decline in function is associated with decreased participation, a decline in health~     status, and an increased need to access the healthcare system. The objective of this project~     is to evaluate the effectiveness of a post-rehabilitation community-based exercise program~     for individuals with COPD and compare the outcomes with those achieved through standard care.~      Individuals with COPD who have completed a previous rehabilitation program will be enrolled~     in the study. Study participants will be assigned randomly to either a year-long community~     exercise program or usual care. Those assigned to the community program will exercise twice~     weekly at a local community centre supervised by trained fitness instructors. A case manager~     will facilitate the transition from the hospital rehabilitation program to the community~     centre. The case manager will also be available to participants and instructors for consult~     as needed. Continuing to build on an established partnership with the City of Toronto, the~     case manager will ensure fitness instructors receive specialized training in order to~     properly supervise and support the individuals with COPD. Participants assigned to usual care~     group will receive standard care by their family physician and respiratory specialist.~     Functional status will be evaluated before the program begins and again at 6-months and~     1-year. The outcome of each group will be compared to determine the effectiveness of the~     community exercise program. It is hypothesized that individuals who participate in the~     community exercise program will have better function and quality of life versus those~     individuals who receive standard care.~   "
124149|NCT01942486|"~     The purpose of this study is to determine if a special coating, applied to the surface of~     glasses can reduce the frequency and severity of migraine headaches in children and~     adolescents. This study is being conducted by researchers at Primary Children's Medical~     Center, The John Moran Eye Center, and the University of Utah Department of Electrical~     Engineering. The investigators have determined that a specific frequency of light is~     particularly bothersome to migraine patients. The coating they've developed is designed to~     block this frequency of light. Very few treatments are approved for the treatment of~     childhood migraine. The investigators hope that these glasses will provide a safe way to~     improve headaches in children.~   "
124150|NCT01942473|"~     In this study the investigators test the hypothesis that automated FiO2 adjustment increases~     the time of brain tissue oxygenation within the intended reference range. Furthermore, the~     investigators studied the change in workload during automated FiO2 adjustment as compared to~     manual adjustment by the nursing staff.~   "
124151|NCT01942460|"~     The purpose of this study is to investigate the efficacy of ferumoxytol for the repletion of~     iron stores and correction of iron deficiency anaemia in patients with severe chronic kidney~     disease or end-stage chronic kidney disease on peritoneal dialysis, and to assess the impact~     of the administration of a ferumoxytol dose on various markers for iron stores, as well as on~     various markers for inflammation and oxidative stress.~   "
124152|NCT01942447|"~     The host gastrointestinal microbiota is significantly influenced by antibiotic treatment~     which might favor Clostridium difficile infection (CDI), a frequent cause of community- and~     hospital-acquired, potentially life-threatening diarrhoea. CDI is followed by recurrence in~     19-35% of patients despite adequate first line antimicrobial therapy. Currently there is no~     standardized therapy of recurrent or refractory CDI, but recent studies show remarkable~     effects of fecal microbiota transplantation (FMT).~      In the current project, we aim to ideally match host and donor for FMT success in recurrent~     or refractory CDI. We will establish a clinical standard operating protocol for FMT, we will~     evaluate its safety and efficacy, and the patient acceptance and quality of life before and~     after FMT. We will analyse persistence of the donor microbiota within the recipient, define~     predictive clinical recipient and donor factors for FMT success and correlate them with~     microbial host and donor metagenomics.~      We hypothesize that our work will yield novel, individualized strategies for recurrent or~     refractory CDI. In perspective, our results may be expanded to treatment of other inflammory~     bowel diseases.~   "
124153|NCT01942434|"~     Purpose: To explore the relation between breastmilk nutrients and the cognitive abilities of~     breastfed infants.~      Phase 1: Near 3 months of age child and mother saliva samples for DNA obtained with breast~     milk sample.~      Phase 2: At 6 months of age child participates in electrophysiology session to test~     recognition memory.~      Phase 3: At 26 or 38 months of age, children will complete behavioral, dietary, and physical~     assessments.~   "
124154|NCT01942421|"~     The purpose of this study is to elucidate the appropriate condition of developing cultivated~     autologous oral mucosal epithelial graft and evaluate the surgical outcome of transplantation~     of the cultivated cells in the patients.~   "
124170|NCT01942213|"~     This open-label, Phase IV prospective, observational study will evaluate patients, who have~     been diagnosed with Neovascular Age-Related Macular Degeneration and have previously received~     either a standard intravitreal injection of ranibizumab or aflibercept, in order to get and~     compare information regarding post-injection inflammatory (irritation in the eye)2-3 days~     post-injection.~      Additionally, patients will be evaluated for visual acuity and pain 2-3 days post-injection.~   "
124197|NCT01941862|"~     The purpose of this study is to test the effectiveness and usability of multiple~     computer-based treatments for mood and anxiety relevant risk factors. The target of the~     treatment is related to cognitive stress, which has been shown to be associated with a~     variety of negative mental health outcomes such as Post-Traumatic Stress Disorder, suicidal~     ideation, and substance use disorders.~   "
124155|NCT01942408|"~     Atrial fibrillation (AF) is the commonest condition affecting the rhythm of the heart and~     causes an irregular and often rapid heartbeat. Developing this condition may cause~     significant health problems and symptoms that affect normal day-to-day activities. Patients~     with AF also have a shorter life expectancy on average. Tablets used to try to normalise the~     heart rhythm rarely work well. As a result, doctors have devised a treatment to try to cure~     this condition. Special wires (called catheters) are used to deliver heat energy (called~     ablation) on the inside surface of the heart. This technique has been used more and more in~     recent years for patients with troublesome symptoms due to AF.~      The aim of the treatment is to draw lines of ablation in specific places in the heart.~     Unfortunately, a lot of patients (almost 50%) get AF again after this treatment and most of~     these patients have a second treatment performed. It is usually found at this second~     treatment that gaps have developed in the lines of ablation that were drawn the first time~     around. The investigators think that electively doing a second treatment to close these gaps~     a couple of months after the first treatment may mean that fewer of these patients will get~     AF again in the future. The investigators also want to find out what factors make a line of~     ablation less likely to develop gaps.~      In this study, participants will be assigned to one of two groups:~        1. a standard care group, who will have a single treatment initially.~        2. a repeat study group, who will have the initial treatment followed by a second~          treatment 8-10 weeks later.~      For patients in the repeat study group, investigators will see how many have developed gaps~     since their first treatment. The investigators will look at where these gaps are and will~     compare this with information collected during the first treatment to try to work out why the~     gap has developed. Any gaps found at the second treatment will be closed again.~      All participants will then be monitored carefully over 12 months to see how many from each~     group get AF again. To do this, all participants will be given a handheld heart rhythm~     monitor to keep until the end of the study. This device is simple to use. Participants will~     be asked to make a 30 second recording of their heart rhythm each day and also whenever they~     have symptoms. These recordings will be downloaded at review appointments arranged 6 weeks, 3~     months, 6 months and 12 months after the initial ablation procedure.~   "
124156|NCT01942395|"~     The purpose of this study is to examine how dietary changes affect the heart and blood~     vessels in patients with hypertension (high blod pressure) who have a condition called 'heart~     failure with preserved ejection fraction (HFPEF). This condition is also known as diastolic~     heart failure or heart failure with normal ejection fraction, and occurs even though the~     heart's pumping function is normal.~   "
124157|NCT01942382|"~     The purpose of this study is to evaluate the pharmacokinetics (study of what the body does to~     a drug) and safety of paliperidone palmitate ranging from 75 to 150 milligram equivalents in~     repeated doses (4 injections) administered in the deltoid muscle (muscle in the shoulder) or~     gluteal muscle (group of muscles present in the buttocks) in participants with schizophrenia.~   "
124158|NCT01942369|"~     The purpose of this study is to describe changes in the intensity of specific endometriosis~     symptoms from baseline pre-surgery to after surgery and subsequent continuous Diphereline~     (Triptorelin Acetate) treatment for up to 24 weeks.~   "
124159|NCT01942356|"~     The purpose of this study is to compare a closed-loop intravenous anesthetic using Bispectral~     Index as a feedback loop and a controller based on reinforcement learning to titrate dose and~     intravenous anesthetic that is manually controlled or a standard volatile anesthetic agent~     titrated by the anesthesiologist to determine improvement in the following parameters as~     compared to controls: time to discharge from the Post Anesthesia Care Unit, post-operative~     nausea and vomiting, pain scores and sedation scores.~   "
124160|NCT01942343|"~     The main objective of this study is to evaluate the incidence of akathisia with Droperidol,~     the prophylactic treatment of post operative nausea and vomiting, used at two different~     doses, versus control group (Ondansetron), in outpatient surgery.The primary endpoint is to~     compare the number of observed akathisia (Barnes score > 1) in the Droperidol arms (0,625 mg~     and 1,25 mg) versus Ondansetron 4 hours after recovery from anesthesia.The assumption is that~     there is a greater risk of akathisia among patients taking Droperidol in prevention of NPVO,~     that among patients taking Ondansetron.~   "
124161|NCT01942330|"~     This study aims to prospectively evaluate a laparoscopic-assisted transvaginal approach for~     colonic resection in adult women that eliminates the need for an abdominal incision to remove~     surgical specimens. It is hypothesized that this LANOS technique will improve patient~     outcomes such as postoperative surgical site infection (SSI) rates, thereby improving patient~     satisfaction and also reducing hospital length-of-stay and cost.~   "
124162|NCT01942317|"~     The aim of the study is to evaluate the role of balneotherapy in obese patients with knee~     osteoarthritis in terms of pain relief, improving joint function and deambulation, on~     endocrinological parameters, quality of life and of reduction the costs to Servizio~     Sanitario Nazionale (NHS).~   "
124163|NCT01942304|"~     The purpose of this split-mouth clinical study is to evaluate the clinical, radiographic and~     histological outcomes of lateral window sinus augmentation with a bovine xenograft or a CPS~     putty bone substitute in posterior maxillary sites and the survival of implants placed in~     these sites following healing.~   "
124164|NCT01942291|"~     Individuals with reduced plasma concentration of high-density lipoprotein (HDL) cholesterol~     are more susceptible to oxidative stress and often present reduced endothelial function,~     which has been mainly related to this susceptibility. Studies in animal and cell models have~     demonstrated that niacin activates both GPR-109A in leukocytes and heme oxygenase-1 (HO-1)~     pathway promoting strong anti-inflammatory and anti-oxidative effects. . In this context, the~     aim of this study was to investigate the short-term effect of niacin on endothelial function~     and verify the existence of interaction of PGD2 receptor antagonist, i.e. laropiprant (LRPT),~     in subjects with low HDL-cholesterol (HDL -C).~   "
124165|NCT01942278|"~     BHOMA Interventions~      The purpose of this study is to assess the impact of the BHOMA intervention on health in 3~     rural districts of Zambia.~   "
124166|NCT01942265|"~     This Phase II randomized, double-blinded, controlled study in up to 1000 males and~     non-pregnant females, 19 to 64 years old, inclusive, who are in good health and meet all~     eligibility criteria is designed to provide data on an A/H7N9 vaccine made with HA antigen~     derived from the influenza A/Shanghai/2/2013 virus.~   "
124167|NCT01942252|"~     The purpose of this study was to determine whether high carboxyhemoglobin level is a risk~     factor for postoperative adverse events in children exposured to carbon monoxide, especially~     enviromental tobacco smoke.~   "
124168|NCT01942239|"~     Hypoglycemia is frequent in very low birth weight (VLBW) neonates and compromises their~     neurological outcome. The aim of this study was to compare real-time continuous glucose~     monitoring system (RT-CGMS) to standard method by intermittent capillary blood glucose~     testing in detecting and managing hypoglycemia. The investigators calculated a number of 48~     neonates to be randomized between 2 ways of glucose level monitoring for their 3 first days~     of life : either by RT-CGMS (CGM-group), or by intermittent capillary glucose testing~     (IGM-group) associated with a blind-CGMS to detect retrospectively missed hypoglycemia. The~     investigators' hypothesis is that in the CGM group number and duration of hypoglycemia will~     be lower.~   "
124172|NCT01942187|"~     The purpose of this study is to compare the effectiveness of two different augmentation~     strategies of antidepressant treatment for depressed older adults who have not responded to~     an adequate trial of antidepressant medication. The first augmentation strategy is Problem~     Solving Therapy (PST), a 12-week psychotherapy treatment that has been shown to be effective~     in depressed older adults. The second augmentation strategy is medication augmentation, which~     will begin with six weeks of aripiprazole, an atypical antipsychotic medication that has also~     been shown to be effective in depressed older adults who have failed a trial of~     antidepressant medication.~   "
124173|NCT01942174|"~     To estimate the rate of immunological answer 1 month after antipneumococcal vaccination by~     the conjugated vaccine Prevenar13 ® in patients suffered from rheumatoid polyarthritis and~     who begin a treatement by methotrexate either in the same time, either 1 month later.~   "
124174|NCT01942161|"~     The objective of this study is to investigate the efficacy and safety of three different~     doses of aripiprazole (2 mg/day, 6-12 mg/day, 24-30 mg/day) orally administered over a period~     of 6 weeks in pediatric patients (aged 13-17 years) with schizophrenia~   "
124175|NCT01942148|"~     The objective of this study is to investigate the safety and efficacy of aripiprazole~     (initial dose 2 mg/day, maintenance dose 6-24 mg/day, maximum dose 30 mg/day) orally~     administered over a period of 52 weeks in subjects who complete a short-term treatment study~     of pediatric patients (aged 13-17 years) with schizophrenia (031-09-003 study).~   "
124176|NCT01942135|"~     The study is a randomized, double blind, placebo controlled, Phase 3 clinical trial with the~     primary objective of demonstrating the superiority of palbociclib in combination with~     fulvestrant (Faslodex®) over fulvestrant alone in prolonging PFS in women with HR+, HER2~     negative metastatic breast cancer whose disease has progressed after prior endocrine therapy.~     The safety between the two treatment arms will also be compared. During study treatment, pre-~     and perimenopausal women must be receiving therapy with the LHRH agonist goserelin (Zoladex®~     or generic).~   "
124177|NCT01942122|"~     This is a 3-arm, prospective, randomized, double-blind, and controlled study of DLBS1442 for~     the treatment of pain in patients suspected endometriosis. It is hypothesized that the~     reduction of the composite-pain intensity (as measured by VAS) from baseline to the end of~     study (week 8th) resulting from administration of DLBS1442, regardless of the dosage regimen,~     is significantly greater than that of Control. In addition, the administration of DLBS1442 at~     higher dose also results in significantly greater reduction than that of DLBS1442 at lower~     dose and of Control.~   "
124178|NCT01942109|"~     The aim of the study is to compare the effects of torasemide and furosemide on clinical and~     biochemical parameters of hemodynamic and neurohormonal compensation and myocardial~     remodeling in patients with chronic heart failure with indications for use of loop diuretics.~      The study protocol 100 patients with heart failure NYHA (New York Heart Association) II-IV~     (stable or exacerbation aligned cardiopulmonary at the time of enrollment, with a fixed-dose~     loop diuretics]) treated with optimal medical therapy as clinically indicated for use loop~     diuretics. Patients will be randomized to treatment with furosemide and torasemide~     (randomization 1 : 1). After randomization, furosemide will continue in its current~     fixed-dose or will be replaced by equipotential dose of torasemide (4:1). The minimal~     follow-up of patients in the study will be at least six months.~   "
124179|NCT01942096|"~     High school elite training programs are today more and more under development in several~     'elite sport schools' in Belgium, in order to select and train future elite athletes already~     at young age. Little is known about the effects of sustained training on the potential~     development of asthma in adolescents during lung growth. It would be of great importance to~     be able to select the individuals at risk to develop exercise-induced asthma, already at the~     start of their enrollment in the 'elite sport school. This would allow physicians to follow~     their lung function parameters very closely and regularly; and, if necessary, start treatment~     early after the first signs of exercise-induced asthma.~   "
124180|NCT01942083|"~     This is a Phase I, open label, non randomized, multicenter study designed to investigate the~     safety and tolerability of escalating doses of OPB-111077 administered orally, once daily in~     subjects with advanced HCC.~   "
124181|NCT01942070|"~     The aim of the current study is to test the clinical performance of the everolimus-eluting~     BVS compared with that of the durable polymer everolimus-eluting stent (EES) in patients~     undergoing PCI in the setting of acute MI.~   "
124182|NCT01942057|"~     The goal of this study is to determine the prevalence of nearsightedness in Canadian school~     children living in the Waterloo Region.~   "
124183|NCT01942044|"~     The purpose of this study is to evaluate the differences of wall shear stress distribution~     among different types of drug-eluting stents and its impact on vessel healing evaluated by~     intravascular optical coherence tomography evaluation.~   "
124184|NCT01942031|"~     Stroke is a devastating disease. The acute mortality in Sweden is 20 % and 25 % of all~     patients relapse. Secondary prevention is proven efficient but observational studies have~     shown that a number of patients are lost to follow up and do not receive recommended~     prevention. The aim of the study is to 1) describe, by analyzing register data, the detection~     rate of patients with hospital diagnosis of stroke, TIA, and atrial fibrillation in the~     primary care center where they are listed. The analysis is done by sex, age, and~     socioeconomic status. Furthermore, rate of dispensed prescriptions of secondary preventive~     drugs are analysed for the identified population. 2) in a randomized controlled study~     evaluate if collegial feed back and targeted information of secondary prevention to the~     intervention group can improve the detection rate and the medication of the patients listed~     at the participating primary care centers.~   "
124185|NCT01942018|"~     This research is being done to study an endoscopic procedure called POEM as a less invasive~     alternative to surgery in people with esophagogastric junction outlet obstruction (EGOO).~   "
124186|NCT01942005|"~     Detection of mutation / specific polymorphism of the EVER/TMC6 and/or EVER/TMC8 gen.~   "
124187|NCT01941992|"~     The purpose of this study is to:~        -  evaluate the activity of SAMITAL in reducing the incidence of severe mucositis in~          head-and-neck cancer patients undergoing chemo-radiotherapy.~        -  assess tolerability of SAMITAL and the impact on patients reported outcomes.~   "
134196|NCT01810783|"~     To determine the safety and efficacy of brexpiprazole during long-term treatment.~   "
124188|NCT01941979|"~     Surgery is the most indicated curative treatment for rectal cancer when disease is diagnosed~     early, however local recurrence risk increases when the disease is diagnosed at advanced~     stage.T1-2 tumors have a recurrence rate lower than 10%, while T3N0 tumors have 15% - 35% and~     positive lymph nodes T3-4 45% to 67% of recurrence rate within 5 years. These data indicate~     that patient who have a high risk of tumor recurrence should receive an adjuvant therapy~     treatment.~      It is possible that adjuvant chemotherapy has a positive impact on survival of patients~     already treated with neoadjuvant combination therapy. However it is necessary to identify~     those patients that might have this benefit.~      An exploratory analysis of the European Organization for Research and Treatment of Cancer~     (EORTC) 22921 study showed that the addition of adjuvant chemotherapy has benefited only the~     group of patients who had a reduction of tumor stage to ypT0-2. In the group who had no~     reduction (ypT3-4), there was no benefit. Retrospective analyzes suggest that the response to~     neoadjuvant chemoradiotherapy is a predictor of prognosis and even benefit to adjuvant~     chemotherapy. However the benefit of adjuvant chemotherapy for patients with rectal cancer~     remains controversial. Therefore, a randomized trial is needed to answer this question.~      Based on these data the investigators proposed a phase III study, randomized, unblinded,~     adjuvant chemotherapy based on Fluorouracil(5-FU) and Oxaliplatin versus observation in~     patients with rectal adenocarcinoma T3-4, N0-1, M0 previously treated with neoadjuvant~     chemoradiotherapy and who did not presented complete response. The investigator believes that~     this subgroup of patients, who have not achieved complete response, will be benefit from~     adjuvant therapy.~      Study objective:~      The main objective of this study is verify if adjuvant chemotherapy with 5-FU and~     oxaliplatin, for 4 months, increases recurrence-free survival versus the observation.~     Secondary objectives include the evaluation of toxicity, overall survival and assessment of~     biomarkers (study protocol separately).~      The study's primary endpoint is disease-free survival (DFS) to be defined as time from~     randomization to radiological detection of distant disease and / or locoregional recurrence.~     Isolate carcinoembryonic antigen (CEA) increase will not be consider as recurrence until a~     new measurable lesion be found.~      NOTE: The TNM system is based on the size and/or extent (reach) of the primary tumor (T), the~     amount of spread to nearby lymph nodes (N), and the presence of metastasis (M) or secondary~     tumors formed by the spread of cancer cells to other parts of the body.~   "
124189|NCT01941966|"~     The squamous cell carcinoma (SCC) of the anal canal is an uncommon neoplasia which~     corresponds to 1-5% of intestinal tumors. However the risk of SCC of the anal canal has been~     growing recently. The standard treatment of anal cancer stage II-III is multimodal and~     consists of combined chemotherapy (infusional 5-fluorouracil and mitomycin) and radiotherapy.~     This scheme currently used was proposed in 1974, and since then no other effective treatment~     has been developed.~      The purpose of this study is to determine the efficacy and toxicity of the combination of~     capecitabine and mitomycin with radiotherapy in patients with carcinoma of the anal canal.~     For this will be selected 51 patients to be treated with chemo-radiotherapy.~      The primary endpoint will be local control rate after 6 months of the end of radiotherapy and~     chemotherapy, defined by the rate of radiological and clinical neoplasia.~   "
124190|NCT01941953|"~     This is a phase II trial to evaluate efficacy and safety of Metformin and Fluorouracil in~     patients with metastatic colorectal cancer (CRC) who have progressed after Oxaliplatin and~     Irinotecan based chemotherapy.~   "
124191|NCT01941940|"~     This open-label, single arm, Phase 3b study will evaluate the efficacy of tocilizumab~     (RoActemra), administered as monotherapy or in combination with methotrexate and/or other~     DMARDs, in participants with moderate to severe active RA.~   "
124192|NCT01941927|"~     This is a multicenter phase II clinical study of trametinib in combination with GSK2141795 in~     patients with BRAF wild-type mutation melanoma. All patients will receive continuous dosing~     of trametinib (2 mg) in combination with GSK2141795 (25 mg) oral daily until progression of~     disease, withdrawal of consent, or the development of intolerable treatment associated~     toxicity. Imaging (CT or MRI) will be performed within 7 days prior to day 1 of Odd Cycles,~     starting with Cycle 3.~      Patients may continue treatment with trametinib in combination with GSK2141795 on trial until~     disease progression or the development of unacceptable toxicity that does not improve with~     maximal supportive care or dose reduction per protocol.~      Treatment-associated adverse events will be assessed based on clinical and laboratory~     findings using the Common Toxicity Criteria for Adverse Events, version 4.0. Adverse event~     assessments will be performed every week through cycle 3 day 1, and on day 1 for every cycle~     thereafter. AEs and SAEs will be monitored by UCSF's Data Safety Monitoring Committee.~      Safety assessments will include medical history, physical examination, CBC with differential,~     chemistries panel, thyroid function and pregnancy tests, ECGs, and ophthalmology evaluations.~     Screening assessments will also include a transthoracic echocardiogram or MUGA scan, and~     brain imaging.~      It is estimated that 48 patients will complete the study.~   "
124193|NCT01941914|"~     The purpose of this study is to evaluate the effect of calcium electroporation on keloids.~   "
124194|NCT01941901|"~     The purpose of this study is to evaluate the effect of calcium electroporation on cutaneous~     metastases, and compare calcium electroporation with standard treatment: electrochemotherapy.~   "
124195|NCT01941888|"~     Many studies address safety and effectiveness of non-anesthesiologist propofol sedation~     (NAPS) for GI endoscopy. Target Controlled Infusion (TCI) is a sophisticated tool for~     providing optimal sedation regimen and avoiding under or oversedation.~      This randomized double blind controlled study compares standard moderate sedation level of~     sedation (group S) during upper endoscopy (EGD) and colonoscopy (CS) versus propofol NAPS~     (group P).~   "
124196|NCT01941875|"~     This is a study of patients undergoing Controlled Ovarian Hyperstimulation (COH) with~     Gonadotropins and Intrauterine Insemination (IUI) at a Fertility Clinic.~      Infertility is a common problem, and a popular method of therapy is to inject sperm through~     the cervix and into the uterus, a procedure known as IUI. In conjunction with IUI, injectable~     medications (gonadotropins) are used to stimulate the ovaries to produce more than one egg~     per cycle in a process called COH.~      Vaginal progesterone is used for luteal support in in vitro fertilization therapy and has~     been proven to effect pregnancy rates. However, the role of progesterone in COH is still~     unclear. In this study, the investigators want to examine the effect of giving vaginal~     progesterone after COH with IUI on pregnancy rates. The investigators want to study if luteal~     vaginal progesterone results in a higher pregnancy rate compared to no progesterone therapy~     in COH with IUI. At present, fertility centres vary in the use of progesterone after~     insemination, most likely due to the lack of studies on this subject.~      At the Fertility Clinic all patients undergoing COH with injectable medications and IUI,~     regardless of whether they are in the study, have a baseline transvaginal ultrasound and~     blood tests. Patients start the injectable medications for COH until the ovarian follicles~     are large enough, then a medication to release the eggs is given. The IUI is done~     approximately 36 hours later. The day after the IUI, study patients will be given vaginal~     progesterone while the control patients will receive no progesterone. All patients will be~     followed until a pregnancy test is done and a viable foetus is confirmed by ultrasound.~   "
134197|NCT01810770|"~     To evaluate the safety and efficacy (Overall survival [OS]) of multiple doses of Ra-223~     dichloride in an Asian population of subjects with CRPC metastatic to the bone.~   "
124200|NCT01941823|"~     Carnitine is essential for the transport of fatty acids into the mitochondria and energy~     production in different muscles, including the myocardium. It is also needed to protect~     myocyte cell membranes from oxidative damage by removing excess acyl carnitine groups.~     Patients receiving chronic intermittent hemodialysis (HD) are known to be at increased risk~     for carnitine deficiency as a result of its removal during the dialysis procedure, lack of~     endogenous synthesis by the kidney, and inadequate dietary intake. The carnitine status of~     children undergoing continuous renal replacement therapy (CRRT) has not been studied.~     Children undergoing CRRT in the intensive care unit (ICU) setting may be at increased risk~     for carnitine deficiency due to its continuous removal, lack of carnitine production by the~     kidney, and absence of carnitine intake (as majority of these children can not eat and there~     is no carnitine added to total parenteral nutrition (TPN). Carnitine deficiency may increase~     the risk of cardiac dysfunction in critically ill children. This is the first study to~     examine carnitine status in children undergoing CRRT. Standard echo as well as more sensitive~     speckle tracking echo will be used to evaluate the effect of carnitine deficiency on~     myocardial function.~   "
124201|NCT01941810|"~     This pilot phase II trial studies how well bovine lactoferrin supplement works in improving~     taste in patients with cancer receiving chemotherapy. Bovine lactoferrin supplement may help~     improve the ability to taste food in patients who are receiving chemotherapy.~   "
124202|NCT01941797|"~     This is a pilot study. The investigators hypothesize that the peri-implant soft tissue~     response to de novo plaque accumulation is similar to that of normal gingival tissue in the~     same subjects.~      The investigators propose to conduct a controlled clinical trial to evaluate peri-implant~     soft tissue response to de novo plaque accumulation in comparison to the response of gingival~     tissue in the same subjects~   "
124203|NCT01941784|"~     This pilot clinical trial studies a health education intervention in reducing weight gain in~     patients with newly diagnosed stage I-IV breast cancer undergoing chemotherapy. A health~     education program may reduce weight gain and improve quality of life in patients undergoing~     chemotherapy for breast cancer.~   "
124204|NCT01941771|"~     The study hypothesis is that metronomic treatment is more efficient than standard treatment.~   "
124205|NCT01941758|"~     This pilot clinical trial studies high-dose trivalent influenza vaccine in inducing immune~     response patients with central nervous system tumors. Studying samples of blood in the~     laboratory from patients receiving trivalent influenza vaccine may help doctors learn more~     about the effects of trivalent influenza vaccine on cells. It may also help doctors~     understand how well patients respond to treatment.~   "
124206|NCT01941745|"~     Bronchopulmonary Dysplasia (BPD) is a multi-factorial disease process that is the end result~     of an immature, surfactant deficient lung that has been exposed to hyperoxia, mechanical~     ventilation and infection. These conditions initiate an inflammatory response characterized~     by elevated inflammatory cell infiltrates and proinflammatory cytokines that lead to the~     development of significant acute and chronic lung injury.~      The study drug, rhCC10, is a recombinant version of natural human CC10 protein. Native CC10~     is produced primarily by non-ciliated respiratory epithelial cells, called Clara cells and is~     the most abundant protein in the mucosal fluids in normal healthy lungs.~      The purpose of this study is to evaluate the pharmacokinetics, safety, tolerability and~     anti-inflammatory effects of a single intratracheal (IT) dose of rhCC10 to intubated~     premature infants receiving positive pressure ventilation for treatment of respiratory~     distress syndrome (RDS) to prevent long term respiratory complications referred to as~     bronchopulmonary dysplasia, and, more recently, as chronic respiratory morbidity (CRM;~     asthma, cough, wheezing, multiple respiratory infections).~      CC10 regulates inflammatory responses and protects the structural integrity of pulmonary~     tissue while preserving pulmonary mechanical function during various insults (eg. viral~     infection, bacterial endotoxin, ozone, allergens, hyperoxia). Together these properties~     suggest that administration of rhCC10 may help to facilitate development of normal airway~     epithelia and prevent the inflammation that leads to CRM in these infants.~      This study is funded by the FDA Office of Orphan Product Development (OOPD).~   "
124207|NCT01941732|"~     Sildenafil (Viagra(R))is widely used by men with Parkinsons Disease (PD) and erectile~     dysfunction. A number of patients have reported that when they take Sildenafil, their need of~     anti-PD medication is reduced.~      We hypotheses that sildenafil increases brain blood flow and hence improves the function of~     specific brain regions, improving motor function.~      Motor function and cerebral blood flow of 8 patients will be tested before and after~     Sildenafil intake and before and after anti-PD medication.~   "
124208|NCT01941719|"~     The purpose of this study is to examine the effectiveness of a novel patient education~     strategy, compared to a standard diabetic foot education. The proposed diabetic foot care~     education uses personal computer-animated plantar pressure data to educate patients on why~     and how they should care for their feet.~   "
124209|NCT01941706|"~     Project UPLIFT, a home-based treatment for depression in people with epilepsy, was designed~     to be delivered to groups by telephone or Web. The Project UPLIFT intervention materials were~     demonstrated to be effective in treating depression among people with epilepsy in Georgia.~     This project will assess whether the materials are also effective for preventing depression~     among people with epilepsy, and will extend the project beyond Georgia to Michigan, Texas,~     and Washington.~   "
124210|NCT01941693|"~     There is a high rate of psychological comorbidity in people suffering from alcohol~     dependence. There is a need for an effective integrated treatment for alcohol dependence and~     comorbid anxiety or depression. This study will test the efficacy of a novel integrated~     intervention for comorbid alcohol dependence and anxiety or mood disorder.~   "
124211|NCT01941680|"~     Patients are recruited at diagnosis or at relapse of ATLL-HR in French Caribbean islands and~     Guyana. They all receive Zidovudine and Pegylated Interferon (ZPI). For patients younger than~     65 years old, an allogeneic donor is searching out. Patients included at relapse and with~     lymphoma clinico-biological subtype also receive chemotherapy (CT). Responses are assessed~     during ZPI+/-CT and eligible patients (depending on age, comorbidities and response criteria)~     receive allogeneic transplant. Patient follow-up is planned for 3 years old~   "
124212|NCT01941667|"~     The investigators want to determine if additional, increased contact with infants and~     families discharged to home after cardiac surgery improves infant and parent outcomes as~     compared to usual care.~   "
124215|NCT01941628|"~     Cesarean delivery under general anesthesia is one of few only surgical procedures, where the~     most important factor of safety is the speed of the surgery, as a newborn adaptation strongly~     depends on a time between induction to the general anesthesia (and administration of~     anesthetics) and pennywort ligation. The shortest possible interval is essential for the~     amount of anesthetics crossing placenta into the fetal circulation.~      The primary objective:~      To compare surgical conditions for fetus delivery in Cesarean section under general~     anesthesia with deep neuromuscular blockade versus standard procedure with succinylcholine.~      The primary safety objective:~      To compare influence of different levels of neuromuscular blockade and surgical conditions on~     newborn adaptation after the Cesarean delivery.~      The secondary objectives:~      To compare influence of deep versus no/shallow muscle blockade during the entire Cesarean~     section on surgical conditions for suture of the uterus and the abdominal wall with attention~     to blood loss, time of surgery and surgical complications.~      To describe pharmacodynamics and pharmacokinetics of deep neuromuscular blockade by~     rocuronium over the course of Cesarean section and its reversal by sugammadex at the end of~     procedure.~      Clinical hypotheses:~      The use of deep muscle blockade in Cesarean section under general anesthesia, including the~     period of fetus delivery, compare to the standard recommended practice with succinylcholine,~     will improve the surgical conditions and allow faster and easier delivery of the fetus with~     positive effect on its postnatal adaptation. Faster delivery will reduce an incision to~     delivery interval with decrease of time between anesthetics administration and delivery. This~     will reduce the amount of anesthetics crossing the placenta to the fetal circulation. Both,~     reduced amount of anesthetics and reduced incision to delivery interval itself will improve a~     newborn adaptation after Cesarean delivery.~      Deep neuromuscular blockade will also improve surgical conditions for the whole surgery, when~     no or shallow only neuromuscular blockade is routinely used. We assume that deep~     neuromuscular blockade during the entire surgery will create better surgical conditions for~     faster and easier uterus suture and the rest of surgery and thus reduce perioperative blood~     loss and incidence of surgical complications.~   "
124216|NCT01941615|"~     Investigate the effect of multiple oral doses of BI 207127 + faldaprevir (FDV) on the~     multiple dose pharmacokinetics of ethinylestradiol and levonorgestrel (Microgynon®) in~     healthy premenopausal female volunteers.~   "
124217|NCT01941602|"~     The aim of the study is to compare different strategies for prevention of venous~     thromboembolism related to intracranial meningioma surgery. The investigators identified~     three hospitals where two have a very restrictive approach with respect to anticoagulant~     therapy while at the third hospital the use of anticoagulation the day before surgery was~     initiated as routine prophylaxis.~      Based on this natural experiment it will be explored whether the use of anticoagulant~     prophylaxis is associated with reduced risk of venous thromboembolism and/or associated with~     increased risk of postoperative hemorrhage as compared to the 2 cohorts where this~     intervention were absent.~   "
124218|NCT01941589|"~     The role of steroids in the treatment of ulcerative Colitis (UC) is well established, and~     recommended by professional societies. However, there are no data investigating whether the~     addition and/or continuation of 5-aminosalicylic agents as combination therapy with systemic~     corticosteroids is superior to corticosteroids alone in patients with moderate-severe active~     UC. Thus, in practical terms, the decision regarding 5-aminosalicylic (to add or continue),~     on top of steroids treatment, is taken on an arbitrary basis. The aim of this study is to~     compare the efficacy of steroids alone Vs combination of steroids + 5-aminosalicylic in the~     treatment of moderate-severe UC exacerbation.~   "
124219|NCT01941576|"~     The purpose of this study is to determine the effects of rhRNP on urine output and~     hemodynamics following corrective repair of Tetralogy Of Fallot.~   "
124220|NCT01941563|"~     The purpose of this study is to evaluate the efficacy and safety of SI-6603 (condoliase) in~     patients with lumbar disc herniation.~   "
124221|NCT01941550|"~     This study is aimed at evaluating the efficacy regarding the response rate and~     metastasis-free survival time of cabazitaxel as a neoadjuvant treatment in patients with high~     risk prostate cancer.~   "
124222|NCT01941537|"~     Atopic dermatitis (AD) is a common inflammatory skin disorder that adversely affects most~     aspects of everyday life in majority of patients. It has a prevalence of up to 3-4% of adults~     and up to 25% among children. AD has a complex pathogenesis, characterized by: 1) immune~     activation with increased numbers of T-cells, dendritic cells (DCs), and increased expression~     of inflammatory molecules 2) marked epidermal hyperplasia in chronic diseased skin, and 3)~     defective barrier function with increased trans-epidermal water loss (TEWL) and decreased~     lipids, reflecting underlying alterations in keratinocyte differentiation. AD is~     predominantly a Th2 (IL-4, IL-13, and IL-31) disease, and recently was also found to be a~     T22 (IL-22) polarized disease.~      ILV-094 is an anti IL-22 antibody and therefore should reverse the immune activation of AD.~     This study is being done to assess the safety, tolerability, clinical efficacy, and mechanism~     of action of ILV-094 in patients with AD.~   "
124223|NCT01941524|"~     The purpose of the study is to determine whether there are differences in bioelectrical~     function (measured by amplitude integrated electroencephalography) and brain oxygenation~     (measured by near infrared spectroscopy) while and after instillation of two different~     surfactant preparations.~   "
124224|NCT01941511|"~     This is a clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential of~     GMI-1070 in African-American Adult subjects. This is conducted as part of standard drug~     development.~   "
124225|NCT01941498|"~     The purpose of this study is to evaluate outcomes of subjects undergoing myopic surgery using~     the WaveLight® Refractive Suite (Excimer EX500 and Femtosecond FS200 lasers).~   "
124226|NCT01941485|"~     The purpose of this study is to evaluate the accuracy of the WaveLight FS200 femtosecond~     laser, as assessed by 1 day and 1 month post-operative optical coherence tomography (OCT)~     anterior segment corneal measurements compared to pre-operative flap thickness target.~   "
124227|NCT01941472|"~     Fluid challenge is often carried out in critical ill patients. Its responsiveness usually~     requires invasive monitoring. To use non-invasive methods is very tempting. Investigators~     hypothesize that transcutaneous pO2,transcutaneous pCO2 and Central Venous SO2 variations~     provide feasible estimation on fluid responsiveness in critical ill patients.~   "
124228|NCT01941459|"~     Thru the last 20 years it has been a discussion witch solution that gives the best myocardial~     protection during cardiac arrest by heart operations.~        -  It has been a tendency that a blood based cardioplegia gives a better protection bye~          long ischemic times but it has not been possible too conclude in this matter.~        -  The investigators have two groups of cardioplegia, the blood based and, the crystalloid~          based cardioplegia.~        -  It has been done a lot of studies to see what kind of cardioplegia that gives the best~          myocardial protection. Different temperature, different amount and content, retrograde~          or antegrade or both, contentiously and further on have been tested without a clear~          conclusion.~        -  The investigators decided to make a study with a cohort of patients as homogenous as~          possible with a cross clamp time around 70 min.~        -  Adult patients' with a severe aortic stenoses without any other significant heart~          disease was included in our prospective randomised study.~        -  Patients with additional significant coronary artery disease (≥ 50% stenoses) were~          excluded from the study.~        -  The investigators used the well known biomarkers CK-MB and troponin-T too evaluate the~          myocardial damage.~   "
124231|NCT01941420|"~     The investigators decided to make a study with a cohort of patients as homogenous as possible~     with a cross clamp time around 70 min. Adult patients with a severe aortic stenoses without~     any other significant heart disease was included in our prospective randomised study. This~     group of patients was chosen for two reasons. First, these patients have left ventricular~     hypertrophy making the myocardium vulnerable to ischemia, secondly the investigators wanted~     to avoid the possible confounding effect of ischemia found in patients with variable degrees~     of coronary artery disease. Therefore, patients with additional significant coronary artery~     disease (≥ 50% stenoses) were excluded from the study.~   "
124232|NCT01941407|"~     The efficacy of eribulin is now well known in metastatic breast cancer. Furthermore, a phase~     III combine study ( chemo + bev)in metastatic first line shown a gain in PFS with no extra~     toxicities.~      It could be interesting to explore the combination of bev + eribulin in first line metastatic~     breast cancer.~   "
124233|NCT01941394|"~     Infusion of Mesenchymal Stem Cell (MSC) at day of recovery after bone marrow transplant (BMT)~     for patients with AL, AA and MM for acute Graft-versus-host Disease (GVHD) prophylaxis and~     treatment.~   "
124234|NCT01941381|"~     Due to recent efforts to decrease antibiotic overuse, and reports of high rates of~     spontaneous resolution for clinically diagnosed Acute Otitis Media(AOM), most physicians now~     wait 48-72 hours before starting antibiotics for common ear infections. The investigators are~     interested to see if those patients with documented middle ear effusions, as determined by~     tympanometry, have higher rates of eventual antibiotic usage than those with normal~     tympanometry results. If there is a significant disparity between those with a positive~     tympanogram and those without the investigators may be able to identify a group that will~     benefit from antibiotics and a group that would not need treatment.~   "
124235|NCT01941368|"~     Objectives: 1) Determine the effect of 4-weeks of high intensity interval training (HIIT) and~     free acid form β-Hydroxy-β-methylbutyrate (HMB-FA) on VO2peak, lactate threshold, critical~     power, anaerobic working capacity and neuromuscular economy in a population of endurance~     trained individuals. 2) Determine the effect of 4-weeks of HIIT and HMB-FA on changes in~     skeletal muscle physiological cross-sectional area (PCSA=Volume/Fascicle length) and muscle~     quality (MQ=echo intensity) in the rectus femoris and vastus lateralis.~      Subjects: Fifty males and females between the ages of 18 - 35 will be recruited to~     participate in this study. Subject will be randomized to one of three groups: a control group~     (CTL), an HIIT only group (HIIT) or a group which will take the amino acid metabolite HMB and~     perform HIIT (HMB-HIIT). Individuals assigned to CTL will undergo baseline testing. They will~     then be asked to continue their normal exercise routine for 4 weeks and will undergo~     post-testing after this time period.~      Study Protocol: Two testing sessions, on nonconsecutive days, will occur at least 72 hours~     prior to the start of the training period. The same testing protocols will be repeated at the~     end of the 4-week training period. Testing protocols include performance testing (VO2peak,~     lactate threshold, critical power, anaerobic working capacity and neuromuscular economy) and~     anthropometric measures (physiological cross-sectional area and muscle quality). The training~     protocol for individuals in the experimental groups will consist of 4-weeks of high intensity~     interval training with three sessions per week on an electronically braked cycle ergometer.~     Individual work -loads will be calculated based on the outcomes from each participant's~     preliminary testing.~   "
124236|NCT01941355|"~     Patients undergoing coronary artery bypass graft surgery often experience a range of problems~     and symptoms related to the procedure and the underlying heart disease. These problems~     include anxiety and depressive symptoms, immobility issues, complications such as wound~     seeping, neck and shoulder pains, interrupted and insufficient sleep. Over the last 2~     decades, cardiac rehabilitation has become recognized as a significant component in the~     continuum of care for persons with cardiovascular disease. Furthermore, cardiac~     rehabilitation has undergone a significant evolution moving from a focused exercise~     intervention to a comprehensive disease management program. In Guidelines for Coronary Artery~     Bypass Graft Surgery cardiac rehabilitation is described to include early ambulation during~     hospitalisation, and outpatient prescriptive exercise training beginning 6-8 weeks following~     surgery. Our hypothesis is that physical exercise with moderate intensity and a~     psycho-educative component as a part of cardiac rehabilitation can begin in early~     postoperatively during hospitalising. Results from studies on phase 1 rehabilitation in~     coronary artery bypass graft surgery patients are promising. However, no randomised trials~     have been conducted, and evidence is therefore lacking.~      The objective of this pilot trial is to investigate the effect of a phase 1 comprehensive~     cardiac rehabilitation programme consisting of a psycho-educative component, an~     exercise-training component including pulmonary training, cycling, neck and shoulder~     exercises, these in combination plus treatment as usual and treatment as usual in patients~     who undergo coronary artery bypass grafting.~      SheppHeartCABG is an investigator-initiated 2 x 2 factorial randomised clinical pilot trial~     with blinded outcome assessment. Recruitment from one site with 1:1:1:1 central randomisation~     to phase 1 rehabilitation; 1) exercise-training plus usual care, 2) psycho-educative plus~     usual care 3) exercise-training and psycho-educative plus usual, 4) usual care alone.~   "
124237|NCT01941342|"~     The purpose of this study is to evaluate the efficacy of preoperative biliary drainage (PBD)~     which is performed prior to pancreatoduodenectomy candidates with obstructive jaundice by~     observing the prevalence of drainage and surgery related complications, hospital stay,~     medical cost and life quality compared to surgery alone. It is anticipated that PBD can~     reduce the prevalence of complications and improve the outcome of pancreatoduodenectomy.~   "
124238|NCT01941329|"~     This study is a prospective, randomized, multicentre, open label study that intents to~     compare the efficacy and safety of ranibizumab 0.5 mg Intravitreal (ITV) injections plus~     Panretinal Photocoagulation versus Panretinal Photocoagulation alone in the regression of the~     neovascularization area in patients with High Risk Proliferative Diabetic Retinopathy over a~     12-month treatment period.~      One of the major complications of the diabetes mellitus is Diabetic Retinopathy (DR), one of~     the leading causes of visual impairment in working age in industrialized countries. Longer~     diabetes duration and poor glycaemic and blood pressure control are strongly associated with~     Diabetic Retinopathy. The overall prevalence of any form of Diabetic Retinopathy is 34.4% and~     6.96% corresponds to Proliferative Diabetic Retinopathy (PDR). Therefore, approximately 93~     million people have Diabetic Retinopathy and 17 million of them have Proliferative Diabetic~     Retinopathy.~      It has been shown that treatment with repeated injections of ranibizumab can improve visual~     acuity in patients with PDR. Further, , the standard PRP treatment of PDR remains~     unsatisfactory. The knowledge of the mechanisms of this retinal complication is incomplete~     and, therefore, efforts should be done to understand and characterize patients' eyes response~     to combined treatments.~      Therefore, the purpose of this study is to compare the standard treatment for PDR (i.e.~     Panretinal Photocoagulation) with Panretinal Photocoagulation treatment combined with ITV~     injections of ranibizumab since it is expected that anti-vascular endothelial growth factor~     (VEGF) treatment with ITV injections will increase the rate of success of Panretinal~     Photocoagulation in regression of neovascularization with improved final visual acuity.~   "
124239|NCT01941316|"~     The purpose of this study is to determine a well-tolerated dose of Carfilzomib in combination~     with Irinotecan (Phase 1b portion of the study) in subjects with relapsed small and non-small~     cell lung cancer or other irinotecan-sensitive cancers and to assess the 6 month survival of~     relapsed small cell lung cancer patients treated with this combination therapy. **The Phase~     1b portion of the study is now complete**.~      Phase 2 portion of the study. The safest, maximally tolerated dose established as established~     in Phase 1 for Phase 2 is as follows -- Carfilzomib will be provided at 20/36 mg/m2 with~     Irinotecan dosed at 125 mg/m2. The purpose of the Phase 2 portion of the study is to assess 6~     month survival of relapsed small cell lung cancer ins subjects treated with this combination~     therapy.~   "
124240|NCT01941303|"~     As one of the few centers, MAASTRO also aggressively re-treats patients with recurrent~     non-small cell lung cancer. Even after primary radical treatment to high doses,~     re-irradiation (with concurrent chemotherapy) is also given in curative intent, thus again~     using high doses of radiation.~      Publications on high-dose re-irradiation of lung cancer patients are scarce, and outcome and~     toxicity for patients treated in MAASTRO are unknown at present. This study will provide~     knowledge on benefit and risks of such a therapeutic approach.~   "
124241|NCT01941290|"~     Cliflical evaluation of th' Orsiro LESS 10 diabetic subjects requiring coronary revasculariza~     t ion with Drug Eluting Stefl ts (DES) .880 subjects will be enrolled in this registry. The~     sample subjects size may be increased in order to reach the subgroup sizes (Small Vessel and~     AMI).~   "
124242|NCT01941277|"~     The purpose of this study is to evaluate the effect of exercise on Insulin Resistance (IR) in~     subjects who do not routinely exercise and who are at risk of developing diabetes~     (prediabetes).~      It is estimated that approximately 30-90 people will participate in this study at three study~     sites in the United States and United Kingdom.~   "
124243|NCT01941264|"~     Malaria is a common disease in Africa and a major health problem. Pregnant women are also at~     risk of malaria. Malaria in pregnancy is life threatening to both the mother and the baby she~     is carrying. It can result in the destruction of the mother's blood and in babies with a~     lower birth weight than normal, making them less healthy in their first years of life. These~     risks are even higher in women having their first pregnancy.~      When a woman is pregnant she should go to the Antenatal clinic (ANC) for care. Usually the~     ANC health staff gives the woman intermittent preventable treatment (IPTp-SP) against~     malaria. This drug helps protect the woman against getting malaria. Each pregnant woman~     should receive at least 2 doses of this drug during their pregnancy; thus, they should go the~     ANC at least 2 times during their pregnancy. However, many women still do not go often to the~     ANC for health care during their pregnancy.~      This study would like to see whether community health workers (CHW) can work with pregnant~     women to encourage them to attend ANC more often. Also, the CHW will test a pregnant woman~     every month for malaria with a rapid test. If a woman has malaria, the CHW will treat her in~     her home instead of the woman having to go a health clinic for treatment. The woman will be~     treated with a different drug than the drug that is given at the ANC visits. Our hypothesis~     is that this will improve the care and management of malaria during pregnancy and this will~     improve the health of women and their newborns. To see whether this strategy improved the~     health of women and their newborns, we will take a small piece of the placenta at delivery to~     test for malaria and we will weigh the baby. We will test this strategy in multiple~     communities. We will compare this to pregnant women in communities where this strategy was~     not followed, thus where pregnant women received standard care.~      Participants will be pregnant women. There are no direct benefits for participating in the~     study, except the outcome of our research question that is possible health benefits in the~     intervention group. The drugs involved are tested safe in pregnant women from second~     trimester on.~   "
124244|NCT01941251|"~     Since 1990s, stimulation of prefrontal cortex (PFC) has shown therapeutic effects on auditory~     hallucinations as well as negative symptoms of schizophrenia. However, previous studies have~     reported mixed or negative results. Majority of the repetitive transcranial magnetic~     stimulation (rTMS) studies to date has set the target of cortical stimulation based on scalp~     site. Recently introduced method, navigated transcranial magnetic stimulation (nTMS)~     integrates the individual MRI data, and thus allows more precise targeting on brain cortical~     regions enhancing the efficacy of rTMS. Previous EEG studies have suggested reduced alpha~     band activity in patients with schizophrenia. Some recent studies using alpha (α) EEG guided~     TMS for treating positive and negative symptoms of schizophrenia have demonstrated promising~     results.~      The aim of the study is to investigate the efficacy of navigated individualized αTMS in~     treatment-resistant patients with schizophrenia. Approximately fifty patients with DSM-IV~     schizophrenia will be enrolled in this randomized, double-blind, sham-controlled study. The~     patients will receive 13 - 15 session of αTMS to the left dorsolateral prefrontal cortex~     (DLPFC), as adjunctive therapy, for 3 weeks. We assess patients via the Positive and Negative~     Syndrome Scale (PANSS), Clinical Global Impression (CGI) and neurocognitive test battery at~     baseline, 5 days after and 3 months after treatment. Serum and plasma levels of brain derived~     neurotrophic factor (BDNF) are assayed at pre and post treatment weeks.~   "
124245|NCT01941238|"~     Managing patients with type1 diabetes when fasting Ramadan is very challenging. Insulin pump~     offers the advantage of flexibility and precision to administering insulin and has been~     proven to reduce severe hypoglycemia compared to multi-dose injection (MDI). However, there~     are extremely limited studies on the difference between insulin pump compared to MDI on the~     incidence of hypoglycemia and other acute complications during fasting Ramadan~      The investigators hypothesized that insulin pump would be associated with less hypoglycemic~     events during fasting Ramadan compared to MDI without deterioration in glycemic control.~     Results of this study are descriptive but will fill a current gap in knowledge and may~     contribute to development of future guidelines for the management of type1DM during Ramadan.~   "
124246|NCT01941225|"~     The purpose of this study is to investigate the role of the pulmonary vasculature in the~     development and progression of chronic obstructive pulmonary disease (COPD). To accomplish~     this, an inhaled prostacyclin (iloprost) will be given to patients with COPD and changes in~     oxidative stress and lung volumes during exercise will be measured.~   "
124247|NCT01941212|"~     To evaluate the effect of musical therapy before and after gynecological surgeries on pain~     relief following surgery.~      The hypothesis is that musical therapy is effective in pain relief following surgical~     procedures.~   "
124248|NCT01941199|"~     This is a randomized, open-label, multiple dosing, three-way crossover clinical trial to~     investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of DA-1229 5 mg and~     Metformin IR 1000 mg after oral administration in healthy male volunteers.~   "
124249|NCT01941186|"~     This is a randomized controlled trial aimed at assessing the effectiveness of a patient~     decision aid (PDA) and text message reminder in promoting early intervention referral~     completion when infants and toddlers are identified with a developmental concern in the~     pediatric medical home. Subjects will be randomized to one of two study arms- (1)~     intervention (2) control condition. Subjects in the intervention arm will watch a video PDA~     and will receive a text message reminder approximately 7 to 14 business days after enrollment~     if they agree to the early intervention referral.~   "
124250|NCT01941173|"~     This pilot clinical trial studies short-infusion ziv-aflibercept in treating patients with~     metastatic colorectal cancer receiving combination chemotherapy. Ziv-aflibercept may stop the~     growth of colorectal cancer by blocking blood flow to the tumor. Giving the drug over a~     shorter infusion time may result in improved efficiency and patient satisfaction.~   "
124251|NCT01941160|"~     The objectives of this study are to evaluate stool consistency and stool frequency during and~     up to 8 weeks following a 7 day antibiotic treatment with Amoxicillin/Clavulanic Acid 875mg~     BID.~   "
124252|NCT01941147|"~     There is great interest in the development of novel therapies for acute ischemic stroke~     because, to date, the thrombolysis is the only approved treatment. Recent evidence suggests~     that extremely low frequency magnetic fields (ELF-MF) could be an alternative approach for~     acute ischemic stroke therapy because of their effects on the main mechanisms of brain~     ischemic damage and regeneration.The main purpose of this open label, one arm, dose~     escalation study is the validation of ELF-MF stimulation as non-invasive, safe and effective~     tool to promote recovery in acute ischemic stroke patients Nine patients will be treated~     daily for 5 consecutive days, starting within 48 h from the onset of stroke. Three dose~     cohorts of three patients each, will be stimulated with pulsed ELF-MF (75 Hz, 1,8 mT) at~     increasing daily exposure (45, 120, 240 min).The primary outcome (safety endpoint) will be~     evaluated by the incidence of adverse events and mortality throughout the stimulation period~     and the 1-year follow-up. Secondary outcomes will consist in change from baseline in clinical~     and radiological scores.~   "
124253|NCT01941134|"~     This study will attempt to determine whether having gastric bypass surgery changes the way~     that the gut absorbs hormones from birth control pills. It is believed that, because gastric~     bypass surgery causes malabsorption of nutrients and some medications, the levels of birth~     control hormones after the surgery will be lower than in women before they have the surgery.~     The investigators will ask several women to take a pack of birth control pills before having~     bypass surgery, and then another pack several months after surgery. The investigators will~     measure hormone levels in the blood. The investigators will also measure outcomes that may~     tell us how well the birth control pills are working, such as ultrasounds of the uterus and~     ovaries, and examination of the cervix.~   "
124254|NCT01941121|"~     This is a CCTG sponsored project to determine if those recently screened for HIV would accept~     assistance to be linked into appropriate health services. After receiving their HIV results,~     high-risk individuals who test negative will have an option to be linked into a study that~     offers them Pre-exposure Prophylaxis (PrEP), and individuals who test positive will have an~     option to be linked into care.~      If they accept, tested individuals will be in contact with an ALERT specialist that will help~     facilitate their linkage. The study's primary analysis will analyze how many HIV screened~     individuals accept the ALERT specialist assistance.~   "
124255|NCT01941108|"~     The purpose of the mPeer2Peer Study (mP2P) is to see if we can use a smartphone and a Peer~     Navigator (PN) to improve medical care for HIV-positive people who have been out of HIV care~     for over one year.~   "
124256|NCT01941095|"~     This multicenter, open-label, single arm study will evaluate the safety and efficacy of~     subcutaneous (SC) tocilizumab as monotherapy or in combination with methotrexate or other~     non-biologic DMARDs in participants with active rheumatoid arthritis who are either naïve to~     or have an inadequate response to prior non-biologic or/and biologic DMARDs. The anticipated~     time on study treatment is 52 weeks. Those participants who will complete the 60-week study~     period and have achieved Disease Activity Score (DAS) 28 remission or a good European League~     Against Rheumatism (EULAR) response at 52 weeks will be eligible to enter the extension phase~     until tocilizumab is commercially available and reimbursed in Greece.~   "
124257|NCT01941082|"~     This multicenter, non-randomized, open-label, single- and multiple-ascending-dose study will~     investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO6867461 in~     patients with wet age-related macular degeneration.~   "
124258|NCT01941069|"~     The overall purpose of this project is to determine whether school personnel implementing a~     two-tier School-wide Positive Behavior Support (SWPBS, an evidence based intervention)~     program for typically developing children as well as children with, or at risk for,~     externalizing or anxiety disorders can implement the components of the program with the same~     level of fidelity, integrity and clinical effectiveness when they receive a low level of~     support (consultation) from their coaches and supervisors as they can with a high level of~     support (consultation and coaching).~   "
124259|NCT01941056|"~     This phase I trial studies the side effects and the best dose of vaccine therapy in healthy~     volunteers with or without previous exposure to cytomegalovirus. Vaccines made from a~     gene-modified virus may help the body build an immune response and may help prevent~     cytomegalovirus infection.~   "
124260|NCT01941043|"~     The current study will evaluate the antidepressant effect of CERC-301 during 28 days of~     treatment in subjects with MDD who are currently experiencing a severe depressive episode~     despite stable ongoing treatment with selective serotonin- or serotonin-norepinephrine~     reuptake inhibitors (SSRI or SNRI). The study population will be enriched for subjects that~     would benefit most from rapid onset, those with recent active suicidal ideation, but not a~     risk to themselves or others and are deemed appropriate for an out-patient study with careful~     safety surveillance. This will allow the study to focus on the antidepressant effects of~     CERC-301 but also explore effects on suicidal ideation. To explore rapid onset, the primary~     endpoint will be at 7 days, but effects over the 28 days of treatment will be examined as a~     secondary endpoint.~   "
124261|NCT01941030|"~     CLARITY I is a pilot study to identify the clinically appropriate endpoint(s) of a larger,~     statistically powered pivotal trial for treatment of patients with Critical Limb Ischemia~     (CLI).~   "
124262|NCT01941017|"~     Comparison between Ovarian reserve markers in patients with minimal/mild endometriosis and~     patients with tubal factor infertility~   "
124263|NCT01941004|"~     To evaluate the safety and efficacy of fingolimod 0.5mg vs. placebo in MS patients in China~   "
124264|NCT01940991|"~     This study will confirm the efficacy and safety of a single topical administration of~     botulinum toxin type A compared to placebo control for the treatment of moderate to severe~     crow's feet lines~   "
134502|NCT01806779|"~     Previous results from the investigators' Center have shown that combination treatment with~     Chantix and Zyban is more successful in helping men quit smoking. The investigators hope to~     replicate these findings with this study.~   "
124265|NCT01940978|"~     Lack of appetite and weight loss are a common side effect of ADHD therapy with amphetamines~     such as methylphenidate. Lack of sufficient food intake has been shown to have negative~     effects on weight and height as well as learning and memory.~      There is no current treatment to prevent this loss of appetite except discontinuation or~     reduction of the methylphenidate. Discontinuation or reduction of the drug can cause the~     return of ADHD symptoms.~      The purpose of this study is to compare the effects, good and/or bad, of two doses of a drug,~     cyproheptadine, vs placebo to find out if cyproheptadine prevents the appetite suppression~     associated with methylphenidate.~   "
124266|NCT01940965|"~     Primary Objective:~      The primary objective of this study is to assess the overall safety of lixisenatide once~     daily treatment in combination with background oral anti-diabetic treatment over 52 weeks in~     patients with type 2 diabetes in Japan.~      Secondary Objective:~      To assess the effects of lixisenatide in combination with background oral antidiabetic drug~     (OAD) on:~        -  HbA1c;~        -  Fasting plasma glucose;~        -  Body weight.~   "
124267|NCT01940952|"~     The purpose of this study is to determine whether Zydena (Udenafil) has positive effect on~     cognitive function in patients with Alzheimer's disease.~      This study is a randomized, double blind, placebo-controlled multicenter study.~   "
124268|NCT01940939|"~     1. Exploration of rTMS on working memory and cognitive impairment symptoms of schizophrenia~          treatment and mechanism.~        2. Analysis of rTMS high-frequency stimulation to the improvement of negative symptoms and~          psychotic symptoms.~   "
124269|NCT01940926|"~     This is an open-label positron emission tomography/computed tomography ( PET/CT) study to~     investigate the diagnostic performance and evaluation efficacy of 68Ga-BNOTA-PRGD2 in~     rheumatoid arthritis (RA) patients. A single dose of nearly 111 MBq 68Ga-BNOTA-PRGD2 (≤ 40 µg~     BNOTA-PRGD2) will be intravenously injected into patients with RA. Visual and~     semiquantitative method will be used to assess the PET/CT images. Whole body 18F-FDG PET/CT~     will be performed for comparison.~   "
124270|NCT01940913|"~     To assess the tolerability and effect of a probiotic product, when co-administered with~     antibiotics, on the incidence and duration of loose/watery stools following the antibiotic~     treatment in children.~   "
124271|NCT01940900|"~     The objectives of this study are to evaluate the safety and efficacy of intravitreal~     administration of Fovista® administered in combination with Lucentis® compared to Lucentis®~     monotherapy in subjects with subfoveal choroidal neovascularization secondary to age-related~     macular degeneration (AMD).~   "
124272|NCT01940887|"~     The objectives of this study are to evaluate the safety and efficacy of intravitreal~     administration of Fovista® administered in combination with either Avastin® or Eylea®~     compared to Avastin® or Eylea® monotherapy in subjects with subfoveal choroidal~     neovascularization secondary to age-related macular degeneration (AMD).~   "
124273|NCT01940874|"~     Use of vasopressor to maintain Mean Arterial Pressure on Cardio Pulmonary Bypass can lead to~     decreased cerebral flow and oxygenation in individual patients and this can be detected by~     means of cerebral oxymetry.~   "
124274|NCT01940861|"~     Vasopressor for current treatment protocols for acute traumatic brain injury can lead to~     vasoconstriction and thus cerebral hypoperfusion that can be detected with cerebral oxymetry~     as a drop in SCO2.~   "
124275|NCT01940848|"~     The study shall prove whether treatment of irritable bowel syndrome with Iberogast is~     superior to placebo regarding the main criterium pain~   "
124276|NCT01940835|"~     This purpose of this study is to determine if activation of a person's immune system in the~     small intestine could be a contributing cause of Type 1 Diabetes.~   "
124277|NCT01940822|"~     This study is being done to look at the cardiovascular response, if any, to intake of~     commercially available energy drink. We hypothesize that energy drink consumption compared to~     a control drink in healthy adults alters the cardiovascular hemodynamic system.The focus of~     this study is to elucidate the physiological/cardiovascular response to an energy drink~     consumption as compared to a control drink both at rest and during stressful conditions in~     healthy adults.~   "
124278|NCT01940809|"~     This randomized phase I trial studies the side effects and best way to give ipilimumab with~     or without dabrafenib, trametinib and/or nivolumab in treating patients with melanoma that~     has spread to other parts of the body (metastatic) or cannot be removed by surgery.~     Monoclonal antibodies, such as ipilimumab and nivolumab, may interfere with the ability of~     cancer cells to grow and spread. Dabrafenib and trametinib may stop the growth of tumor cells~     by blocking some of the enzymes needed for cell growth. It is not yet known whether~     ipilimumab works better with or without dabrafenib, trametinib, and/or nivolumab in treating~     melanoma.~   "
124279|NCT01940796|"~     This research study is trying to determine the safest dose of Brentuximab Vedotin that can be~     given to patients with chronic GVHD and see if chronic GVHD improves.~   "
124280|NCT01940783|"~     One of the contributing factors to the variability in outcomes amongst Cochlear Implant (CI)~     recipients was reported to be the placement of the electrode array in the scala tympani. It~     seems that the correct placement of the electrode initially into the scala tympani and~     subsequent avoidance of dislocation into the scala vestibuli as the insertion progresses, is~     a key factor in achieving good speech perception outcomes. Another important aspect related~     to the performance is the achievement of consistent electrical coverage with the electrode.~     Data reported for electrodes of different manufacturers give depths ranging from 240 - 600~     degrees showing the considerable variation across subjects. The HiFocus mid scala electrode~     was developed to cover one and a quarter turn and with the pre-curved design to be less~     susceptible to variations in individual cochlea dimensions and insertion techniques. A~     further mechanical feature of the pre-curved design is the avoidance of forces against the~     cochlear lateral wall and associated lower susceptibility of the electrode for moving out of~     the cochlea following insertion. Recently, a cone beam CT (CBCT) technique is being explored~     in the field of ENT with the potential to overcome some of the issues associated with the~     conventional CT techniques such as scattering, radiation and low isometric resolution. Images~     with comparable details to those of e.g. micro CTs are possible with much lower radiation~     dose. Modern imaging software i.e. 3D Slicer (www.slicer.org) may be used for 3D~     reconstruction, post processing and Brainsfit for registration. Registration is the alignment~     of two scans in the same coordinate system. This enables the identification of differences~     between two images recorded at time x and y. Once accurately superimposed any difference~     between the two images may be identified with an accuracy of 0.2 mm. Using these methods, one~     can assess the stability and the position of the electrode in the cochlea.~      Objective: The primary objectives of this study are to evaluate the feasibility of using cone~     beam CT technique in combination with (high resolution) MRI to identify electrode movements~     following cochlear implant surgery and identify the inter-scalar position of the HFms~     electrode. The secondary objective is to quantify the average insertion depth and variations~     of the HFms electrode~   "
124281|NCT01940770|"~     To confirm the safety and efficacy of Bydureon in long-term use in Japanese patients with~     type 2 diabetes mellitus under actual drug use.~   "
124282|NCT01940757|"~     An experimental hookworm infection model is being developed to provide early proof-of-concept~     that a hookworm vaccine targeting the blood-feeding pathway of adult hookworms is feasible~     and efficacious. The proposed model consists of vaccinating healthy, hookworm-naïve adults~     with a candidate hookworm vaccine, followed by challenging them with the investigational~     product, Necator americanus Larval Inoculum to assess the effect of vaccination on infection.~     The first proposed study will be a feasibility study that will consist of administering~     different doses of the Necator americanus Larval Inoculum to healthy adult volunteers to~     determine the optimal dose (i.e., number of infectious larvae) that is safe, well-tolerated~     and results in consistent infection.~   "
124283|NCT01940744|"~     This study is designed to compare the outcomes of two types of manual therapy techniques on~     patients with low back pain. Both immediate- and long-term outcomes will be examined. The~     investigators hypothesize there will be no differences between the two applied treatment~     techniques in immediate and longer-term assessments.~   "
124284|NCT01940731|"~     1. To evaluate the clinical and microbiological efficacy and safety of Colistimethate~          sodium Injection Vial to treat adults with hospital-acquired pneumonia .~        2. To Learn the pharmacokinetic characteristics of continuous intravenous infusion of~          Colistimethate sodium.~   "
124285|NCT01940718|"~     It is believed that when androgen (testosterone) levels are below normal there is a~     disturbance of normal bodily functioning that is associated with priapism in some men.~     Conversely, it is believed that testosterone replacement will improve the condition of~     priapism when the testosterone levels are brought to normal. In turn, this will also improve~     psychological well being in men with sickle cell disease (SCD).~   "
124286|NCT01940705|"~     Hearing loss is the second most prevalent service-connected disability among Veterans.~     Hearing aids are the most common technological intervention for hearing loss. The VA,~     therefore, spends a considerable amount of money on them. Despite these expenditures, there~     are some Veterans who do not use their hearing aids successfully. Research has demonstrated~     that this inconsistent use may be related to a patient's inability to effectively take care~     of, and use, hearing aids. The proposed investigation will compare the effectiveness of three~     different tools for enhancing the educational efforts (hearing-aid orientation) typically~     provided by clinical audiologists when dispensing hearing aids. Each of these educational~     tools were developed using established methods for improving patient-provider communication.~     The investigators hypothesize that the use of these tools will result in better hearing-aid~     outcomes for Veteran patients than using the current standard-of-care procedures.~   "
124287|NCT01940692|"~     Through a randomized controlled trial, we will compare the intravenous administration of~     tranexamic acid with the intra-articular application after a total hip arthroplasty through~     direct anterior approach.~        -  RCT, prospective study~        -  Academic-monocentric study~        -  Clinical outcome measurements The postoperative blood loss will be the primary outcome.~          Secondary outcomes are~             1. The rate of perioperative and postoperative blood transfusion~             2. The number of blood units transfused~             3. The length of hospital stay~             4. Perioperative given intravenous isotonic fluid~      The Null-hypothesis is that there is no significant difference in postoperative blood loss~     between intra-articular and intravenous administration of TXA.~   "
124288|NCT01940679|"~     Omega-3 fatty acids (n-3s), particularly eicosapentaenoic acid (EPA) and docosahexaenoic acid~     (DHA), have anti-inflammatory properties and other documented beneficial health effects that~     could warrant n-3 fortification of combat rations. However, military combat rations must meet~     rigorous shelf-stability guidelines (e.g.,, 3 years at 80°F or 6 months at 100°F), which is~     problematic for natural food sources of n-3s (e.g., oil and fish), which degrade when exposed~     to high temperatures and prolonged shelf-storage. Encapsulation, e.g., coating freeze dried~     n-3s with gelatin, can prevent this degradation, and Natick Soldier Research, Development and~     Engineering Center's (NSRDEC) Combat Feeding Directorate used encapsulated n-3 technology to~     produce n-3 enriched ration items that withstand environmental stressors and meet shelf-life~     specifications for military rations. However, the bioavailability of the encapsulated n-3s in~     these rations is unknown, particularly when they are incorporated into high-protein food~     items and exposed to high temperatures and prolonged storage. In this randomized, cross-over~     study, civilian and/or military personnel will be asked to consume: 1) a high protein food~     item enriched with encapsulated n-3s (600 mg) and previously stored for 6 months at 100°F; 2)~     a low-protein food item enriched with encapsulated n-3s (600 mg) and previously stored for 6~     months at 100°F; 3) a high protein food item with encapsulated n-3s (600 mg) that was not~     subjected to high-temperature and prolonged storage; and, 4) a low-protein food item with~     encapsulated n-3s (600 mg) that was not subjected to high temperature and prolonged storage.~     Serial blood sampling to measure acute changes in the circulating fatty acid profile will~     occur in the hour before and 6 hours after consumption of each ration component. The only~     known risks, which this study presents to participants, are those associated with venous~     catheter placement. The results will help military ration developers determine the ration~     components best suited for n-3 fortification.~   "
124289|NCT01940666|"~     STUDY QUESTION: Which of the four abnormally elevated androgen groups (total testosterone~     [TT], androstenedione [A4], free androgen index [FAI], or dehydroepiandrosterone-sulfate~     [DHEA-S]) present with an unfavorable metabolic and hormonal profile, appear to be more~     insulin-resistant and pose additional cardiovascular risk? SUMMARY ANSWER: Subjects with~     excess free androgen index tend to be obese and face the highest metabolic syndrome risk,~     adipocytokine alterations, insulin resistance (IR) and cardiovascular risk. The excess TT~     group presents with a marginal IR risk, while the excess A4 group has the highest~     antimüllerian hormone (AMH), and may counterbalance obesity; this group and the excess DHEA-S~     group have a favorable association with IR.~   "
124290|NCT01940653|"~     Cryopreserved-thawed embryos are often replaced in an artificial cycle, in which the~     endometrium is prepared by exogenous estrogen and progesterone with or without the use of~     GnRH agonist downregulation. The correct duration for exposure to progesterone is still not~     well established. To date, there are no prospective randomized trials available, comparing~     different durations of progesterone supplementation before the date of transfer, with regard~     to treatment outcome (Nawroth).~      In this trial, the investigators want to determine the optimal duration of progesterone~     supplementation: 3 or 5 days before embryo transfer.~   "
124303|NCT01940484|"~     This observational study will evaluate the efficacy and use of Methoxy polyethylene~     glycol-epoetin beta (Mircera) in participants with Stage V chronic kidney disease on~     hemodialysis receiving an erythropoietin prior to study entry. Attending physicians should~     have made the decision of placing the participant on methoxy polyethylene glycol epoetin beta~     in advance and not related to the study. The therapy will be administered by the attendant~     treating physician according to specifications in the package insert guidelines and to the~     routine of the site.~   "
134555|NCT01806090|"~     This double-blind, randomized trial aims to evaluate whether uninterrupted anti-platelet~     therapy (clopidogrel) will increase the risk of bleeding associated with removal of polyp~     during colonoscopy in patients with coronary artery disease.~   "
124291|NCT01940640|"~     To date, the investigations in the field of the supplementation with DHA in premature babies~     have been focused on the study of neuronal and visual development, giving place to~     contradictory and ambiguous results, because they did not consider in many cases important~     aspects of this supplementation, such as the mother´s diet, dose, duration, etc., and precise~     studies have not been performed in the field of the oxidative damage, inflammation and bone~     development in this population.~      Hypothesis: If the composition of the mother´s milk is modified on the basis of her diet, a~     mother supplementation with high doses of DHA will increase proportionally the levels of this~     fatty acid in her milk, fact that will allows the premature newborn child receive a major~     dose of this fatty acid, and therefore this way, we will manage to improve the neuronal and~     visual development and to take part on the inflammatory process, oxidative damage and its~     evolution, together with the development or bone mass increase in the premature baby.~      Aims: Overall we aim to evaluate in a multidisciplinary way the effect of a mother~     supplementation during the lactation with high doses of DHA on the development and wellness~     of the premature newborn children. We try to deepen into the effect on the neuronal and~     visual development and to study, for the first time, the effect on the oxidative damage, pro-~     and antiinflammatory citoquines activity and bone metabolism in this group of newborn babies.~   "
124292|NCT01940627|"~     The General Aim of this study is to verify if a short term supplementation can modulate~     diverse aspects related to the physical regular high intensity activity. To get this general~     aim and following the criteria established by the EFSA Guides, this general aim will be~     divided in specific or concrete aims, and will be studied by its specific analytical.~      First Specific Aim: To study how the supplementation with 200 mg of ubiquinol in a short term~     (2 weeks) study can influence the physical performance, resitance , muscle function and~     weakening: maintenance of normal muscle function, maintenance of endurance performance,~     increase in endurance performance/capacity, reduction in the rated perceived exertion/effort~     during exercise, increase in physical performance and maintenance of muscle mass and~     piscological variables that the sportsman suffers before and after the high intensity~     exercise.~      Second Specific Aim: To study how the supplementation with 200 mg of ubiquinol in a short~     term (2 weeks) study can influence the biochemical and haematological parameters in~     sportsman.~      Third Specific Aim: To study how the supplementation with 200 mg of ubiquinol in a short term~     (2 weeks) study can influence the oxidative stress asociated to a high intensity exercise.~      Fourth Specific Aim: To study how the supplementation with 200 mg of ubiquinol in a short~     term (2 weeks) study can influence the inflammatory signaling, the activity of diverse pro -~     and anti-inflammatory citokines associated to high intensity exercise.~   "
124293|NCT01940614|"~     Prospective evaluation of the novel biomarker copeptin in the differential diagnosis of~     diabetes insipidus against the standard diagnostic test methods.~   "
124294|NCT01940601|"~     The primary objective of this study is to find the optimal dose of balugrastim by~     characterizing its pharmacokinetics (PK), and by comparing the pharmacodynamics (PD) of~     balugrastim to filgrastim in children receiving chemotherapy.~   "
124295|NCT01940588|"~     Opioid Dependent Patients who have failed back surgery syndrome are detoxified and treated~     with a neuropsychoanalytic paradigm.~   "
124296|NCT01940575|"~     - Study design:Multi-center, randomized, double-masked (Unblinded treating investigators),~     intra-individual comparison clinical trial~   "
124297|NCT01940562|"~     Platelet recovery is significantly hampered following umbilical cord blood transplantation~     (UCB). Thus, after UCB transplantations, patients are platelet transfusion-dependent for~     prolong periods of time.~      Eltrombopag is a thrombopoietin-receptor agonist that initiates thrombopoietin-receptor~     signaling and thereby induces proliferation and maturation of megakaryocytes.~      We will evaluate the safety and efficacy of eltrombopag for enhancing platelet engraftment in~     pediatric patients undergoing cord blood transplantation.~   "
124298|NCT01940549|"~     The purpose of this study is to test whether transcranial direct current stimulation (tDCS)~     can enhance the clinical efficacy of trauma-focused therapy for posttraumatic stress~     disorder.~   "
124299|NCT01940536|"~     The goal of this study is to determine if the use of tranexamic acid, a safe and effective~     antifibrinolytic, in patients with intertrochanteric hip fractures will result in a reduction~     in blood transfusion rates. Treatment will be administered pre-operatively as well as at the~     time of surgical incision. The primary outcome will be need for blood transfusion. Secondary~     outcomes will include calculated perioperative blood loss, length of stay, cost of inpatient~     care, and rate of adverse events, including DVT, PE, infection, MI, cerebrovascular event,~     need for re-hospitalization or re-operation and 30 day mortality.~   "
124300|NCT01940523|"~     The purpose of this study is to determine whether topical or intravenous administration of~     tranexamic acid during unilateral total knee replacement is more effective at reducing~     bleeding in the first 24 hours following surgery. Tranexamic acid is a synthetic drug that~     has been shown to reduce blood drain output and the need for blood transfusions in both its~     topical and intravenous forms and is commonly used in orthopedic surgery. We hypothesize that~     IV and topical administration of tranexamic acid will be equally good at reducing the loss of~     blood and the need for transfusion immediately following total knee replacement.~   "
124301|NCT01940510|"~     This single center, open-label, 3-period, fixed-sequence study will evaluate the effect of~     multiple oral doses of rifampin on the pharmacokinetics of a single oral dose of RO5424802 in~     healthy volunteers. Subjects will receive a single dose of RO5424802 on Days 1 and 17 and~     rifampin daily from Days 8 to Day 20.~   "
124302|NCT01940497|"~     This non-randomized, multicenter, open-label study will assess the safety and efficacy of~     subcutaneously administered trastuzumab in participants with early and locally advanced~     HER2-positive breast cancer in two sequential cohorts. First 120 participants will be treated~     with subcutaneous (SC) trastuzumab 600 milligrams (mg) vial (Cohort A) and the subsequent 120~     participants will be treated with SC trastuzumab prefilled single use injection device (SID)~     (Cohort B). Participants from each cohort will receive neoadjuvant or adjuvant chemotherapy~     consisting of doxorubicin every 3 weeks (q3w) (1 cycle) for 4 cycles followed by paclitaxel~     weekly or docetaxel every 3 weeks (q3w) in combination with SC trastuzumab (600 mg) q3w for 4~     cycles and a further 14 cycles of SC trastuzumab (600 mg) q3w alone. All participants will be~     followed up for 24 months after the last participant has received the last dose of study~     treatment, or earlier in case of withdrawal from the study, loss to follow-up or death.~   "
124305|NCT01940445|"~     At least thirty (30) subjects, Fitzpatrick-Goldman Skin Type II-V will be enrolled in 2~     clinical sites; each clinic will enroll at least 15 subjects.~      Subjects should present visible wrinkles and/or elastosis requiring treatment.~      Hypothesis: The SST will improve the appearance of the wrinkles/elastosis as well as general~     skin tone by at least 25% as compared to M22 ResurFX 1565nm module alone, for at least 75% of~     the subjects.~   "
124306|NCT01940432|"~     This research is primarily to compare effectiveness of electroacupuncture and pelvic floor~     muscle training for SUI, and evaluate optimal efficiency of electroacupuncture for stress~     urinary incontinence (SUI). The early clinical research is a randomized controlled trial~     (RCT) with a small sample,consisting of two arms of electroacupuncture group and sham~     electroacupuncture group to value difference of extent of SUI in 1h pad test after 4 weeks.~     The result indicates that electroacupuncture is an optimal method for SUI. As a further~     study, this research is a large sample multicenter trial with two parallel arms of~     electroacupuncture group and pelvic floor muscle training group. The primary purpose is to~     value effectiveness of electroacupuncture for SUI in aspect of frequency of leakage and~     amount of leakage, comparing with pelvic floor muscle training. And the secondary purpose is~     to evaluate safety of electroacupuncture therapy, and compare acceptance of~     electroacupuncture treatment and pelvic floor muscle training.~   "
124307|NCT01940419|"~     In Denmark, 4400 women annually undergo hysterectomy on benign background (surgical removal~     of the uterus). 10% of these women experience bleeding complications. The drug Tranexamic~     Acid (Cyklokapron) has showed significant reduction of bleeding in relation to other types of~     surgery. The hypothesis of this study is that Tranexamic Acid could also reduce the operative~     bleeding associated with benign hysterectomy. The study will be carried out as a randomized,~     placebo-controlled national multicenter trial~   "
124308|NCT01940406|"~     The current study is designed to test the hypothesis that targeted electrical stimulation~     will result in upper limb tremor reduction in ET and PD patients.~   "
124309|NCT01940393|"~     The antihistamines with inhaled steroids are the cornerstone on the symptomatic therapy in~     the management of patients with rhinitis and the first line of treatment in patients with~     urticaria. Currently, the use of antihistamines has become popular due to its excellent~     safety profile and clinical efficacy, however to the investigators knowledge, there are no~     studies about the pharmacokinetic and pharmacodynamic effects of these drugs in patients of~     tropical Latin America. The investigators main interest is to evaluate if skin test~     inhibition correlates with the clinical effect of five anti-histamines.~   "
124310|NCT01940380|"~     Postmenopausal Osteoporosis is characterized by a decrease in bone mass as well as a~     deterioration of the bone architecture resulting in an increased risk of fracture,which is~     directly related to the lack of estrogen and also associated with a variety of genetic and~     acquired factors. Previous studies have found that POP molecular regulation mechanism of~     kidney Yang deficiency syndrome may be associated with LTBP1 gene expression.~      This topic using RT-PCR and Western Blot detection POP of kidney Yang deficiency group and~     healthy group LTBP1 mRNA and proteion's expression level,validate LTBP1 relevance to POP the~     kidney Yang deficiency syndrome.To provide a scientific basis for clinical treatment.~   "
124311|NCT01940367|"~     The purpose of this study is to determine whether transcutaneous sacral nerve stimulation~     (TENS SNS) versus percutaneous tibial nerve stimulation (PTNS) is a more effective~     therapeutic option for subjects with idiopathic overactive bladder (OAB) who have failed~     conventional therapy. Our primary hypothesis is that TENS therapy is a more effective~     treatment option due to ease of use and improved subject compliance with this form of~     therapy.~   "
124312|NCT01940354|"~     The study will test a hypothesis that the AccuCath™ System will have a higher rate of~     successful first attempt peripheral IV placement and higher clinician and patient~     satisfaction compared to Conventional IV Catheters.~   "
124313|NCT01940341|"~     The primary objective of this study is to compare the efficacy, safety, and tolerability of~     tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive and~     treatment-experienced adults with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B~     virus (HBV) infection.~   "
124314|NCT01940328|"~     The purpose of this study is to evaluate the lung Doppler signals in left HF patients with~     and without pulmonary congestion (i.e. decompensated left HF patients and compensated left HF~     patients respectively), in comparison to a control group of subjects without CHF (non-CHF~     controls), in order to determine the diagnostic value of this non-invasive method in CHF. If~     this method will prove to be of diagnostic value, it could potentially be used to diagnose~     and monitor CHF patients in both inpatient and outpatient settings.~   "
124315|NCT01940315|"~     This Phase 3 clinical trial is a double blind, placebo-controlled, randomized, multicenter~     investigation of rBV A/B in male and female healthy adults 18 to 55 years of age.~   "
124316|NCT01940302|"~     Due to metabolic disorders and dietary restrictions, patients with diabetes may have~     different degrees of malnutrition. The primary objective of this study is to investigate~     whether supplementation of LEHEL, a multi-nutrients supplement, is capable to improve~     metabolic parameters in patients with type 2 diabetes.~   "
124317|NCT01940289|"~     The primary aim is to examine whether there is a consistent range of pressure threshold~     values for the asymptomatic foot.Previous studies established the inter/intra-clinician~     reliability of pressure threshold measuring and have established a normative range of values~     within the trunk and upper body. Since the establishment of these values, pressure threshold~     testing has been used extensively in the head, neck, shoulders and spine as a clinical tool~     and a research aid. There has been little work using it in the lower limb and there are no~     guideline measurements for the clinician. By establishing a range of values for the foot,this~     study will enable the clinician to employ pressure threshold measuring as a clinical tool to~     easily and accurately identify areas of dysfunction and to objectively measure the~     effectiveness of treatment. It will allow the clinician to establish a degree of improvement~     or deterioration as it occurs in a patient's condition.~      Secondary aims are to examine whether there is a correlation between visual analogue pain~     scale (VAS) scores and algometric pressure threshold scores for subjects with forefoot pain.~     This will help validate the tool for use in the foot. Since VAS is well documented and~     validated, this study will examine whether there is a correlation between VAS and algometry~     and whether there are gender or age differences in the range of measurements obtained. These~     areas have been addressed in previous studies but results have been contradictory and~     inconclusive and none of the previous studies focused on the foot.~      An asymptomatic group of 384 subjects & symptomatic group of 160 subjects shall be selected~     from those attending a podiatric clinic for routine foot care who meet the inclusion criteria~     . Outcome me will be algometric pressure threshold testing, visual analogue pain scales and~     foot function index questionnaires.~   "
124318|NCT01940276|"~     The primary goal is to prospectively estimate the median radiographic PFS of African American~     and Caucasian men with mCRPC to abiraterone acetate and prednisone.~   "
124319|NCT01940263|"~     Oxidative stress and inflammation are involved in the pathogenesis of non-alcoholic fatty~     liver disease (NAFLD). Anthocyanins from different plant foods have been shown to improve~     features of experimental NASH, such as oxidative stress, dyslipidemia, liver steatosis, and~     inflammation in rodents. The purpose of this study is to investigate whether purified~     anthocyanin supplementation beneficially alters oxidative, inflammatory, and apoptotic~     biomarkers in adults with features of NAFLD.~   "
124320|NCT01940250|"~     Hand foot and mouth disease (HFMD) is a common infectious disease caused by a number of~     different viruses - a small proportion of children infected with a particular type of~     enterovirus (EV71) develop neurological and systemic complications that may prove fatal. Very~     large epidemics of EV71 related HFMD have occurred across Asia in recent years; in 2011, in~     excess of 100,000 Vietnamese children were diagnosed with HFMD and 164 died.~      In children with severe HFMD the particular part of the brain that regulates the heart, blood~     circulation, and breathing responses can be affected. Management of this complication is very~     difficult and we currently use an expensive drug (milrinone) that is hard to obtain and has~     significant side effects, without having good evidence that it is effective.~      Magnesium sulphate (Mg) is a cheap, readily available drug that has been used in other~     diseases with similar complications, and we have preliminary data from a small case series~     that suggests it might be a good treatment for HFMD patients with signs indicating this type~     of brain involvement.~      We think that early intervention with Mg, when signs of brain involvement are still~     relatively mild, will control this problem better than waiting until it is well established~     and giving milrinone as at present, and this in turn may prevent progression to severe~     disease. The aims of the project are to evaluate the effects of Mg on hypertension, signs of~     brain dysfunction, outcome (death or neurological sequelae), changes in a variety of blood~     and urine components, and measures of cardiovascular function, in severe HFMD.~      The study design is a randomized double-blind placebo-controlled clinical trial. Children on~     the pediatric intensive care unit with a clinical diagnosis of hand, foot and mouth disease~     will be eligible for enrolment if the blood pressure exceeds the internationally recognized~     threshold for Stage 1 hypertension, they exhibit at least one other sign of brain stem~     dysfunction, and there is written informed consent by a parent or guardian.~      According to the randomization, patients will receive an initial loading dose followed by a~     maintenance infusion, of either Mg or identical placebo for 72 hours; all staff involved in~     patient care will remain unaware of the treatment allocation, but staff from another~     department will monitor Mg blood levels to ensure safety and adequate dosing. A total of 190~     patients (95 in each arm) will be recruited.~   "
124321|NCT01940237|"~     There is now overwhelming evidence documenting the efficacy of psychotherapy in the treatment~     of depression in the general population. Surprisingly, however, given the high prevalence of~     depression in cancer patients, there are very few studies on the efficacy of psychotherapy in~     this population. Published studies of psychotherapy in cancer patients generally include~     patients with high heterogeneity of psychiatric diagnosis and frequently include patients~     without a psychiatric diagnosis, with the aim of preventing the appearance of a psychiatric~     disorder. This heterogeneity complicates the interpretation of the efficacy and specificity~     of these interventions. Specifically, the efficacy of psychotherapy for major depression in~     patients with cancer is unknown.~   "
124322|NCT01940224|"~     The purpose of this study is to evaluate how effective is the preoperative administration of~     pregabalin 300mg, to attenuate postoperative pain and opioids consumption after laparoscopic~     colorectal surgery~   "
124323|NCT01940198|"~     This observational study will aim to determine long-term atazanavir experience in a high HIV~     caseload primary care practice in Sydney, Australia.~   "
124324|NCT01940185|"~     A Post-Approval Study of the LINX® Reflux Management System in a prospective, multicenter,~     single-arm study, with patients as their own control to monitor the safety and efficacy of~     the LINX implant procedure and device in a post-approval environment to supplement existing~     safety and efficacy data.~   "
124325|NCT01940172|"~     This is a dose escalation study in female subjects with relapsed ovarian cancer (including~     epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer).~     Approximately 30 to 40 subjects will be administered a combination of conatumumab and~     birinapant.~      In the initial dose-escalation stage of the study, adult female subjects will receive~     conatumumab in combination with increasing doses of birinapant in dose-escalation cohorts to~     determine the MTD of birinapant when administered with a fixed dose of conatumumab.~      In safety expansion stage, adult female subjects will receive conatumumab in combination with~     birinapant at the MTD of the combination.~   "
124326|NCT01940159|"~     This is a single-center, randomized, single-blind, placebo-controlled, ascending single oral~     dose study designed to evaluate the safety, tolerability, and pharmacokinetic (PK) profiles~     of SEP-363856 and its metabolite SEP-363854 in male and female subjects with schizophrenia.~   "
124327|NCT01940146|"~     The study will assess the efficacy and safety of SPARC1310 when compared to placebo and~     active control~   "
124328|NCT01940133|"~     This study is a Phase I, open label study to determine the Maximum Tolerated Dose(MTD) and~     the Recommended Phase II Dose (RP2D) in patients with advanced solid tumors.~   "
124329|NCT01940120|"~     Prospective, multi-center, single arm registry. Clinical follow-up at discharge, 30 days, 6,~     12, 18 and 24, months, and 3, 4 and 5 years.~      Concurrent Control (CC) group identified retrospectively from the patients screened for the~     HRR who did not enroll; patient survival determined at 12 months. NCT00209274 (EVEREST II~     RCT) Intended use Percutaneous reduction of clinically significant mitral regurgitation in~     symptomatic patients who are considered to be high risk for operative mortality (high~     surgical risk).~   "
124330|NCT01940107|"~     To observe the effect of domiciliary physiotherapy on the upper limb applied during the~     period of radiotherapy in women submitted to surgical and radiotherapy for breast cancer. The~     parameters evaluated were: shoulder range of movement (ROM) and arm circumference. There was~     significant difference between the ipsilateral and contralateral limbs for flexion, abduction~     and external rotation. There was no difference in perimetry in either group~   "
124331|NCT01940094|"~     This study is a multi-center randomized controlled trial to evaluate the effects of using~     low-dose prednisone as compared to stopping prednisone treatment entirely. Participants will~     be randomized 1:1 to taper their prednisone dose down to 5 mg/day or to 0 mg/day for the~     duration of the study (approximately six months) or until a study endpoint.~   "
124344|NCT01939925|"~     The purpose of this randomised controlled trial is to compare a new standardised summary~     format for presentation of synthesised evidence from systematic reviews for the public (a new~     plain language summary format) to the current format used in Cochrane systematic reviews. The~     study will evaluate if the new presentation improves understanding about the benefits and~     harms of an intervention, if it improves the accessibility of the information, and if it is~     preferred over other versions by the public over the current format.~   "
124332|NCT01940081|"~     Rationale: Sudden cardiac death, mainly caused by ventricular arrhythmias (VA), is a major~     cause of morbidity and mortality in non-ischemic cardiomyopathy (NICM). Therapies that~     effectively prevent VA are lacking. Improved understanding of the substrate and mechanisms of~     VA in NICM may allow more effective, individualized and substrate-based therapies to be~     developed. In addition, risk stratification in NICM needs to be improved so that therapies~     can be allocated more efficiently.~      Objectives: 1) To improve our understanding of the underlying pro-arrhythmic substrate and~     electrophysiologic mechanisms of VA in NICM, and to develop individualized treatment for VA~     based on the identified substrate. 2) To improve risk stratification for VA and sudden~     cardiac death in NICM based on substrate characteristics. 3) to evaluate disease progression~     in NICM.~      Hypothesis: Improved understanding of the substrate and mechanisms of VA in NICM may allow~     more effective, individualized and substrate-based therapies to be developed.~      Study design: A prospective cohort study.~      Study population: The study population will consist of three groups (A, B and C): NICM~     patients with documented VA, suspected VA or intermediate to high risk for VA (according to~     established criteria) who are not referred for cardiac surgery (group A), NICM patients with~     documented VA, suspected VA or a high risk for VA who are referred for cardiac surgery (group~     B) and a control group consisting of patients without NICM who are referred for cardiac~     surgery (group C).~      Evaluation: All patients will be evaluated according to current standards for patients with~     NICM. Evaluation will include 24h-Holter, echocardiography, coronary angiogram and~     contrast-enhanced MRI (CE-MRI). If CE-MRI is performed in another hospital, additional~     recordings will be performed in our hospital. Additionally, blood samples (arterial, cardiac~     venous and peripheral venous) for collagen turnover markers will be taken from all patients.~     123-iodine metaiodobenzylguanidine (123-I MIBG) imaging, electrophysiologic study and~     endomyocardial biopsy will be performed in group A and B. Intra-operative biopsy will be~     performed in group B and C.~      Intervention: In group B, intra-operative mapping and cryo-ablation and postoperative~     electrophysiologic study will be performed in patients with subepicardial late enhancement on~     MRI or induced VA suspected for an subepicardial origin.~      Main study parameters/endpoints: The main study parameters are extent, location and pattern~     of fibrosis on imaging and in biopsy specimens. The main study endpoints are inducibility of~     VA, type of induced VA, spontaneous VA and type of spontaneous VA.~   "
124333|NCT01940068|"~     The purpose of this study is to evaluate the impact of a new Amino-acid based formula on~     allergic symptoms and growth of infants with cow's milk protein allergy and intolerant to~     extensively hydrolysed formulas;~   "
124334|NCT01940055|"~     Goal:~      The development of a Treadmill Rehabilitation Platform (TRP) for task-orientated~     rehabilitation that provides an adapted, blended approach among older adults with balance,~     mobility, and cognitive impairments.~      Study Objective:~      Examine the feasibility and benefits of a novel dual-task intervention to address mobility~     and cognitive decline with age using engaging interactive video games during treadmill~     walking and recumbent cycling.This will include evaluation of the effects of two~     interventions, one using treadmill walking and the second a recumbent cycle ergometer on~        1. Core balance~        2. Cardiac fitness, exercise endurance~        3. Gaze control~        4. Gait performance measure (walking stability and spatial-temporal gait parameters)~        5. Specific executive cognitive function (processing speed, cognitive inhibition, working~          memory)~        6. Dual task function during treadmill walking~      Hypothesis:~        1. Dual-task exercise program will improve core balance and walking function to a greater~          extent in the Treadmill walking group compared to recumbent cycle group.~        2. Executive function will improve equally in both the treadmill walking and recumbent~          cycle group.~        3. Dual task exercise programs will have significant effect on gaze stability and cardiac~          fitness equally for both the treadmill and recumbent cycling groups.~   "
124335|NCT01940042|"~     The investigators think that a simple maneuver at laparascopic surgery to reduce the~     postoperative pain.~   "
124336|NCT01940029|"~     Neurosurgical ICU patients often receive hyperosmotic diuretics or cerebrospinal fluid (CSF)~     drainage to decrease their intracranial pressure. It is also common to keep them under~     normovolemia or mild hypervolemia status for stable cerebral perfusion pressure (CPP). These~     patients have large urine output on average, and can decrease the reabsorption of specific~     medicines by renal tubules. Besides, hypervolemia status might increase the volume of~     distribution for hydrophilic medicines, and lower their serum concentration. Therefore, the~     pharmacokinetic characteristics in this population may be different from general population,~     which impacts the efficacy and toxicity of medicines with narrow therapeutic index.~      Vancomycin is used mainly for MRSA (methicillin-resistant S. aureus) infection, and possesses~     a significant place of therapy in treatment of neurosurgical patients' post-operation~     infection. The serum concentration of vancomycin exhibits a clear relevance to its efficacy~     and toxicity. From the investigators' preliminary research of the disposition of vancomycin~     in neurosurgical ICU patients, the investigators found that their vancomycin serum~     concentrations were lower than expected, which can be attributed to their 40% higher mean~     vancomycin clearances than that of neurosurgical general ward patients. However, no definite~     mechanism leading to this phenomenon was confirmed.~      In this study, the investigators prospectively recruit a cohort of adult neurosurgical ICU~     patients to validate the investigators' preliminary pharmacokinetic parameter models for~     vancomycin. Furthermore, the investigators will also demonstrate the contribution of~     different vancomycin elimination routes, renal and CSF drainage eliminating routs, to its~     total clearance, and the relationship between vancomycin renal clearance and creatinine~     clearance. Exclusion criteria include renal failure, unstable renal function, obesity, shock~     status, third space fluid accumulation, burn and pregnancy. The models to validate are used~     for empirical vancomycin dosage calculation. Therapeutic drug monitoring (TDM) is conducted~     after vancomycin serum concentration achieves steady state, and the predicted and observed~     serum concentration of vancomycin are compared to evaluate the consistency. On the other~     hand, vancomycin excreted from urine and CSF drainage fluid would be calculated to see their~     independent contribution for total vancomycin clearance. Meanwhile, the investigators try to~     investigate the mechanism for renal elimination of vancomycin by its association to~     creatinine clearance values calculated from urine creatinine concentration data.~      Bringing all the information together, the investigators hope to provide helpful information~     for the clinical pharmacokinetics of vancomycin therapy in neurosurgical patients, and to~     optimize empirical vancomycin dosing and improve treatment success. Through this study, the~     investigators also wish to understand the possible pharmacokinetic change of other medicines~     in this population, and provide an important source of reference for clinical treatments.~   "
124337|NCT01940016|"~     This randomized clinical trial studies the feasibility of tailored physical activity~     intervention that is administered using Interactive Voice Response technology and cell~     phones. Interactive voice response and health coach support may motivate overweight~     postmenopausal women to stick to their exercise regimen to reduce the risk of getting breast~     cancer.~   "
124338|NCT01940003|"~     The purpose of this study is to verify the efficacy of an aquatic physical exercise program~     on GDM control and adverse maternal and fetal outcomes.~   "
124339|NCT01939990|"~     The purpose of this study is to demonstrate the safety and effectiveness of the study drug~     Nebivolol, in people who suffer with high blood pressure with Chronic Obstructive Pulmonary~     Disease (COPD).~   "
124340|NCT01939977|"~     To demonstrate the superiority of paricalcitol treatment at early renal post-transplantation~     (M6) in the control of iPTH (Intact parathyroid hormone) compared to the use of vitamin D~     nutritional supplements (calcifediol) in patients with renal transplantation.~   "
124341|NCT01939964|"~     To determine the effect of Activation Mist (AM) on skin wrinkles and appearance.~   "
124342|NCT01939951|"~     This study aims to find out if AES ( Activation Energy Serum) , a blend of natural minerals ,~     is effective and safe for the treatment of asthma if taken for 4 weeks . The efficacy will be~     scientifically tested by symptoms scores, questionnaires, breathing and blood tests.~   "
124343|NCT01939938|"~     Our group has recently found that the choice of positive airway pressure mask can~     significantly affect the pressure required to adequately treat sleep disordered breathing.~     The goal of this study is to visualize the upper airway in the retropalatal and retroglossal~     region while using both oronasal and nasal masks with CPAP in order to investigate~     differences in upper airway dynamics that may occur between these two mask types.~   "
124354|NCT01939795|"~     The investigators hypothesis that exercise training would potentiate the effects of cardiac~     resynchronization therapy in heart failure patients.~   "
124345|NCT01939912|"~     The isolated response of the carotid bodies to local stimulation with adenosine has not been~     researched in humans. There are single reports indicating that intravenous administration of~     adenosine causes hyperventilation through activating the carotid bodies.~      Adenosine will be injected intraarterially during invasive treatment (percutaneous carotid~     artery stenting, CAS) or diagnostic (arteriography) procedures and their conduct will only~     slightly influence the standard scheme of the procedure.~   "
124346|NCT01939899|"~     This is an open-label, multicenter, phase 2 study to evaluate the efficacy and safety of oral~     IXAZOMIB in adult patients with follicular lymphoma (FL) that is relapsed and/or refractory~     to prior treatment.~   "
124347|NCT01939886|"~     Artemisinin combination therapy (ACT) with artemether lumefantrine (AL) is currently the~     first line treatment policy in Kenya. AL is an efficacious drug that also has the capacity to~     reduce malaria transmission to mosquitoes. Nevertheless, there is concern about the~     development of parasite resistance against AL. Clinical trials in Asia showed that~     mefloquine-artesunate (MQ-AS) may be more efficacious than AL and may have a more pronounced~     beneficial effect on post-treatment malaria transmission. MQ-AS is registered and used in~     Kenya but there have been no reported direct comparisons of AL and MQ-AS with clinical and~     transmission endpoints (i.e. adequately clearing parasites and preventing transmission to~     mosquitoes).~      Screening for molecular markers that are related to parasite susceptibility to ACT drugs and~     to post-ACT treatment malaria transmission can assist strategies to prevent the development~     and spread of ACT resistance.~      In the current study, we compare AL and MQ-AS for the treatment of uncomplicated malaria. Our~     endpoints are i) clinical efficacy, ii) post-treatment gametocytaemia by molecular~     techniques.~      In the current study, the investigators compare AL and MQ-AS for the treatment of~     uncomplicated malaria. The investigators endpoints are~      clinical efficacy post-treatment gametocytaemia by molecular techniques~   "
124348|NCT01939873|"~     The use of fundal pressure in management of the second stage of labor is controversial. The~     aim of this study is both to evaluate the effectiveness of fundal pressure in shortening the~     second stage of labor and to examine the related neonatal and maternal outcomes.~   "
124349|NCT01939860|"~     Hypertension is a major health problem, however its control is unsatisfactory. One of the~     reasons for such a high prevalence of this disease includes poor patient compliance to~     treatment. Approximately 30 % of newly diagnosed hypertensive patients stop taking their~     blood pressure medication by six months and 50% by 12 months.~      The UK government is keen to encourage community pharmacists to play an active role in~     participation of services that can improve patient adherence to their medications. The New~     Medicines Service (NMS) and targeted Medicines Use Reviews (MUR) are established services~     which fund community pharmacists to review and explain medicine use to patients, with~     hypertension a common condition for which advice is given within these schemes. Within these~     schemes, advice is verbal and unstructured, with no specific written information provided on~     drugs or the disease being treated.~      This study aims to determine whether structured information provided to participants verbally~     and in writing by community pharmacists about blood pressure and current medicine(s) within~     NMS and targeted MURs will be retained and will be associated with improved hypertension~     control. Participants will be recruited from people eligible for NMS and MURs and attending~     community pharmacies.~   "
124350|NCT01939847|"~     This study will test the feasibility of identifying patients who could benefit from tumor~     molecular profiling, of analyzing the patients' tumors in a timely (28 day) fashion, and of~     the identification of possible actionable mutations that are not just biologically~     interesting but are clinically relevant. The investigators will also examine the outcome data~     from patients who followed the Molecular Profiling Tumor Board suggestion compared with those~     who did not.~      When the tissue studies are done, an additional group of patients will be enrolled to test if~     the same is possible in blood samples.~   "
124351|NCT01939834|"~     The purpose of this study is to use an Advisory/Automated Adaptive (AAA) Control system for~     insulin delivery in adults with Type 1 Diabetes (T1DM) in an outpatient setting to evaluate~     the system's ability to significantly improve blood glucose levels. One component of this~     study is evaluating if the AAA Control system run on the Diabetes Assistant (DiAs) system can~     prevent hypoglycemia during and following exercise more efficiently during a 40 hour trial.~     Another component of this study is evaluating AAA Control overnight only in 5 consecutive~     overnights. This protocol represents a culmination of prior clinical trials in development of~     this AAA system and benefits from the synthesis of those components.~   "
124352|NCT01939821|"~     The investigators are planning to do a cluster randomized trial to test the effect of~     different educational programs for staff according to nursing home patients FI (fecal~     incontinence). Since there are very few published trials of treatment of FI in older people,~     and no rigorously evaluated studies on interventions for FI in nursing homes, or rigorously~     evaluated continence education program for staff concerning continence care, a pilot study is~     necessary. The aim for the pilot study is to evaluate feasibility, acceptability and~     adherence according to the educational intervention, methods used and outcome measures. This~     is designed to be an external pilot study. External pilot studies are small scale versions of~     the main study which are not intended to be part of the main study. The pilot intervention~     period is 3 month.~   "
124353|NCT01939808|"~     Hand flexor tendons bend the fingers down towards the palm, and can be cut during a sharp~     penetrating injury (e.g. from a knife or saw). Damaged flexor tendons are repaired surgically~     with sutures (stitches). After repair, a splint is applied to the fingers, hand and wrist for~     six to twelve weeks to protect the repair while the tendon heals and regains its normal~     strength.~      Most rehabilitation protocols use a splint in which the wrist position is kept straight~     (neutral) or bent (flexed). Some groups have described splinting with the wrist cocked back~     (extended) and have made the argument that this may improve outcomes, as experimental data~     suggests that splinting the hand with the wrist extended increases the range of movement of~     the repaired flexor tendon (excursion), and therefore reduces the chance of the tendon~     sticking down to the surrounding tissues (adhesion). Previous studies have shown no adverse~     effects from splinting hands with the wrist extended, and no evidence tells us which wrist~     splint position is better (a state of clinical equipoise or apparently equivalent outcomes).~     This randomised trial aims to produce this evidence, and therefore improve functional~     outcomes for patients in future.~      We propose to carry out a study to compare the outcomes (grip strength and range of movement)~     of flexor tendon repair in two groups of patients: one with wrists splinted in a neutral~     position and the other splinted in an extended position during their postoperative~     rehabilitation. No changes will be made to patient assessment and management,the surgery~     undertaken and the rehabilitation regime other than those to splint position. Previous work~     suggests that both positions are safe and effective. Informed consent will be obtained from~     all patients enrolled in the trial, and we aim to find out if the extended splint position~     produces better functional results.~   "
124355|NCT01939782|"~     This study is undertaken to explore whether compared to extension of overnight fast until~     lunch versus the breakfast consumption influence the oscillation of the metabolic clock gene~     expression in peripheral blood cells (PBC), at noon and after isocaloric lunch in type 2~     diabetic patients.~   "
124356|NCT01939769|"~     Background:~      - Research has shown that one exercise session may improve a person s ability to recall~     information they learned before the exercise. Knowing how exercise changes brain activity to~     improve memory can help researchers understand how memory works and how to improve it in~     people with memory problems. This study compares two kinds of exercise on a stationary bike~     for their ability to temporarily improve memory on certain tests. Researchers will look at~     the effect of exercise on body chemistry by drawing blood and collecting saliva.~      Objectives:~      - To understand how a single session of exercise affects memory testing in healthy people and~     people who have had traumatic brain injury (TBI).~      Eligibility:~        -  Adults ages 18 through 45 with TBI.~        -  Healthy adult volunteers, ages 18 through 45.~      Design:~        -  Participants will be screened with medical history and physical exam. This will take~          about 1 hour.~        -  Participants with TBI will also be screened with a test of their memory. This will take~          another hour.~        -  Visit 1 will take about 3 hours. Participants will:~      <TAB>- Have a tube inserted in their arm for drawing blood during the tests.~      <TAB>- Take memory tests. They will look at pictures, symbols, and words, then answer~     questions.~      <TAB>- Give a saliva sample by chewing on a small sponge for 2 minutes.~      <TAB>- Exercise on a stationary bike.~      <TAB>- Take the memory tests again.~      - Visit 2 will take place 1 week later. Participants will take the memory tests only.~   "
124357|NCT01939756|"~     Baobab oil is often used in traditional medicine as antipyretic, antioxidant,~     anti-inflammatory, analgesic and antimicrobial. It also regenerates the epithelial tissue in~     a short time improving tone and elasticity. We want to evaluate the effects of intravesical~     Baobab oil in patients with BCG-induced lower urinary tract symptoms.~   "
124358|NCT01939743|"~     Transrectal ultrasound guided biopsy of prostate (TRUS-Bx) is widely used as accepted mode of~     investigation for prostate cancer in current urology practice. It is considered a minor~     procedure, which most of the patients tolerate, however 20% of patients refuse to undergo the~     redo procedure without any analgesia or anesthesia but on the other hand, some authors reveal~     that 65 to 90% of patients report pain ranging from mild to severe in intensity. Diclofenac~     is a local and systemic anti-inflammatory drug and it reduces local mediators involved in~     local pain.The purpose of this study is to find out the role of rectal administration of~     diclofenac suppositories as an adjunct to 2% xylocaine gel in alleviating intra and post~     procedural pain in prostatic biopsy with adequately calculated sample size and excluding the~     patients with contraindication to procedure or diclofenac administration as these were the~     shortcomings of previous studies.~   "
124359|NCT01939730|"~     The goal of this clinical research study is to see if using the drugs Rituximab (IDEC-C2B8)~     and Granulocyte-macrophage colony-stimulating factor (GM-CSF) (Leukine) together is better~     than using rituximab alone to treat follicular B-cell lymphomas. The safety of this treatment~     will also be studied.~   "
124360|NCT01939717|"~     Primary aim is to conduct a pilot trial to determine:~        1. The feasibility and efficiency of randomisation procedures and study design~        2. If recruitment rates are sufficient to adequately power a larger trial~      The secondary aim is to determine the efficiency of set dancing in comparison to a control~     for people with Patkinson's disease.~   "
124361|NCT01939704|"~     It is increasingly clear that the environment in which a child lives, plays, and goes to~     school has a significant impact on their health. With the implementation of a Community to~     Clinic Linkage Program (CCLiP) in the SFGH Pediatrics Clinics, we will routinely address~     Social Determinants of Health when families present. We will randomize patients to receive~     either the CCLiP intervention or standard of care. We will evaluate programmatic outcome,~     health care utilization data and return on investment data. We hypothesize that by addressing~     the environmental and social factors that contribute to health within the setting of the~     medical home, we will be able to better connect families to community resources, enable more~     appropriate use of healthcare resources, improve health status, and enhance patient~     satisfaction.~   "
124362|NCT01939691|"~     Macular edema is a condition in which there is swelling in the macula, the part of the retina~     that gives you your best vision. This swelling can cause your vision to decline. When~     diagnosed early and treated, you vision usually can be preserved. However, if the swelling~     goes untreated for a long time, it can cause permanent vision loss.~      We think that the three eye drop regimens in this study, difluprednate, difluprednate plus~     nepafenac, and prednisolone acetate plus nepafenac, might be effective in treating uveitic~     macular edema. Patients who enter this study are randomized to one of the three regimens and~     followed for 24 weeks.~   "
124363|NCT01939678|"~     The purpose of this study is to investigate whether mutations in genes coding for~     Na/Pi-cotransporters are associated with aortic valve calcification. A patient population~     with premature aortic valve calcification treated with aortic valve replacement will be~     screened for mutations in these specific genes. Furthermore, aortic valve tissue received~     from the operations, will be examined for the presence of Na/Pi-cotransporters, and for~     molecular characterization of the transporters.~   "
124364|NCT01939665|"~     Irreversible electroporation (IRE) is a new, minimal-invasive image-guided treatment method~     for tumors not amenable for surgical resection or thermal ablation, due to vicinity near~     vital structures such as vessels and bile ducts. With IRE, multiple electrical pulses are~     applied to tumorous tissue. These pulses alter the existing transmembrane potential of the~     cell membranes, and create 'nanopores', after which the cell dies through loss of~     homeostasis.~      The purpose of this study is to investigate the safety of percutaneous IRE in the treatment~     of patients with locally advanced pancreatic carcinoma (LAPC). Other objectives are~     feasibility and efficacy of IRE based upon symptomatic response and tumor response.~      Fourty patients with histologically confirmed locally advanced pancreatic adenocarcinoma~     (<5cm) will undergo percutaneous irreversible electroporation of the tumor using CT and~     ultrasound guidance. After IRE, patients will be carefully monitored and any (serious)~     adverse events are registered. Follow-up will consist of frequent CT scanning, as well as~     serum CA19.9 tumor marker.~      We hypothesize that IRE in the pancreas will induce good symptom palliation and local tumor~     control, without causing severe complications.~   "
124365|NCT01939652|"~     Elective minilaparatomy abdominal aortic aneurysm (AAA) repair is associated with a~     significant number of complications involving respiratory, cardiovascular, gastrointestinal~     and central nervous system, and mortality ranging up to 5%. In our study, we tested the~     hypothesis that intraoperative and postoperative intravenous restrictive fluid regime reduces~     postoperative morbidity and mortality and improves the outcome of the treatment of~     minilaparotomy AAA repair.~   "
124366|NCT01939639|"~     Social touch can convey the most potent and salient of socio-emotional signals. While the~     hypothalamic peptide oxytocin (OXT) has been identified as a key neurochemical mediator of~     grooming in some other social species, its modulatory influence on human interpersonal touch~     is unknown. The investigators expect that OXT augments the hedonic value of touch and that~     this behavioral effect is paralleled at the neural level by an increased response in brain~     areas mediating rewarding aspects of social touch.~   "
124367|NCT01939626|"~     The purpose of this study is to compare human embryo in vitro development in sequential and~     single-step culture medium using time-lapse imaging.~   "
124368|NCT01939613|"~     The present study was to evaluate the effectiveness of colloid compared with crystalloids for~     fluid resuscitation in critical burn patients with total burn surface area ≥50%.~   "
124369|NCT01939600|"~     Dietary fiber is a type of carbohydrate which is not digested in the human small intestine.~     Whole grains are a source of dietary fiber that are used to promote health; however, using~     whole grains in commercial products results in a different taste and/or texture than the~     usual products made from refined grains. Thus, other types of high-fiber ingredients have~     been developed which can be incorporated into food products with less effect on their taste~     and/or texture. An example of this is resistant starch, defined as starch which is not~     digested in the human small intestine. The digestibility of starch is usually determined~     in-vitro; however, there is evidence that such methods may overestimate the amount of~     resistant starch by as much as 100%. The measurement of the amount of carbohydrate in the~     ileal effluent, digestive waste, of subjects with an ileostomy is considered to be the best~     in-vivo method of starch digestibility. The subjects collect ileal effluent during the day~     during which time they consume a polysaccharide-free diet. There is evidence that resistant~     starch consumed at breakfast is completely recovered in ileal effluent 8-10hr after~     consumption. The purpose of this study will be to compare the carbohydrate content recovered~     in ileal effluent of 10 subjects with a conventional ileostomy.~   "
124370|NCT01939587|"~     This is a single-center, double-blind, randomized trial utilizing a three-period, balanced~     block design, with each period comprising a unique study product administration. The~     treatments studied are PBF-680 5 mg, PBF-680 20 mg and placebo, as an orally administered~     capsule. The study includes a screening visit, a selection visit, three visits for the~     randomized treatment sequence, and an end-of-study follow-up visit, spanning through a 65-day~     maximum study duration. The study will be conducted on 18 male or female adults aged ³18~     years, with a diagnosis of stable, mild to moderate asthma as per GINA guidelines, with no~     smoking or less than a 5 packs-years smoking history history, responsive to AMP airway~     challenge as determined in the selection visit.~      The primary efficacy variable will be the PC20 yielded from AMP airway challenge testing at~     the three treatment visits. FeNO, sampled at three time points at each treatment period~     visit, will be a exploratory variable. Safety assessment will include monitoring of adverse~     events, physical examination, vital signs, EKGs, spirometry, serum and urine pregnancy tests,~     and laboratory determinations. Blood sampling at a time-point series will provide~     pharmacokinetics data.~      The primary variable of the study is PC20, mg×mL-1. The PC 20 distributions will be analyzed~     by treatment using ANOVA for repeated measurements, followed by post hoc pairwise comparisons~     as appropriate. Other analyses will comprise FeNO, pharmacokinetics, data sets generated from~     baseline characteristics and safety assessments, and discretionary expiratory analyses to~     evaluate the influence of baseline and clinical covariates on the primary variable.~   "
124371|NCT01939574|"~     This is a single-center, open-label, single arm study to explore whether potential image~     biomarkers correlate with efficacy of bevacizumab combined with conventional therapy in newly~     diagnosed glioblastoma.~      Despite the increase in therapies available, the median survival of patients with~     glioblastoma multiforme (GBM) remains less than 15 months.~      The phase III pivotal study in newly diagnosed GBM also met its co-primary endpoint of~     progression-free survival (PFS) which further confirm the efficacy of bevacizumab in GBM.~      Early predicting the efficacy of bevacizumab combined with conventional therapy in newly~     diagnosed glioblastoma could help us to identify the suitable patients to receive suitable~     treatment in GBM. Thus, characterizing the blood flow and blood volume in the tumor and their~     changes during therapy might provide information on vasculature growth or collapse,edema~     formation, tumor growth, and/or cell death(necrosis) .We decided to investigate whether the~     estimation of blood circulation in tumor, using MRI,PET could be used as a surrogate marker~     to predict the early response of GBM to bevacizumab.~      Several previous studies have demonstrated that the relative cerebral blood volume (rCBV)~     correlated with the histologic grade of gliomas and investigated the prognostic value of the~     tumor CBV for survival.In current study, We hypothesized that, the temporal changes during~     anti-angiogenesis therapy in specific regions of high and low perfusion in glioblastoma might~     predict the efficacy of bevacizumab.Since there is no mature PET tracer directly image~     Vascular Endothelial Growth Factor (VEGF) in China,we use~     18F-Galacto-arginine-glycine-aspartic acid (RGD)—— a new tracer for PET imaging of αvβ3 by~     testing Standardized uptake value mean (SUVmean),Standardized uptake value max (SUVmax) and~     tumor to non-tumor tissue ratios (T/NT) to indirectly reflect the VEGF expression. The~     integrin αvβ3 is an important receptor affecting tumor growth, local invasiveness, and~     metastatic potential. Specifically, αvβ3 is highly expressed on activated endothelial cells~     during angiogenesis.~      Therefore, in the pilot study, we use dynamic contrast enhanced magnetic resonance imaging~     (DCE-MRI),dynamic susceptibility-contrast magnetic resonance imaging (DSC-MRI) and~     18F-Galacto-RGD PET to explore the potential image biomarkers of bevacizumab used in newly~     diagnosed glioblastoma.~   "
124372|NCT01939561|"~     Myotonia is a functional limiting symptom where the muscle stiffens on action leading to~     arrest of movement. Pharmacological treatment may make the difference between a physically~     restricted and a normal life. Today, patients with myotonia are treated with Mexiletine a~     medications resulting in adverse events up to 40 % and which very expensive and difficult to~     obtain.~      Our clinic has, forced by the above problems related to Mexiletine, treated a few patients~     with the drug Lamotrigine with pronounced positive effect in all. Lamotrigine belongs to the~     same category of drugs as Mexiletine but has fewer and milder side effects. Based on the~     similarities of the 2 drugs in pharmacological action and the positive experiences~     investigators are convinced that Lamotrigine will show a positive effect if evaluated in a~     broader scale. Due to the advantages of Lamotrigine compared to Mexiletine investigators find~     it of outmost importance for patients that this drug is assessed formally to establish~     Lamotrigine as a treatment choice for myotonia. Investigators believe that this will~     potentially make a huge difference in life quality for persons with myotonia. Investigators~     aim at investigating the efficacy and tolerability of Lamotrigine in the treatment of~     myotonia in a randomized doublet blinded placebo controlled crossover study.~   "
124373|NCT01939548|"~     This study aims to evaluate whether PF-02545920 is safe and effective in the treatment of~     sub-optimally controlled symptoms of schizophrenia during a 12-week outpatient treatment~     period. The study will use the Positive and Negative Syndrome Scale (PANSS) to measure change~     in symptoms for PF-02545920 from baseline compared to placebo.~   "
124374|NCT01939535|"~     The purpose of the study is to evaluate the value of MRI in preoperative stratification of~     endometriosis patients needing surgical approach by gynaecologists only or multidisciplinary~     approach by gynaecologists, urologists or/and abdominal surgeons.~   "
124375|NCT01939522|"~     Children/ young people with diabetes may be at a higher risk of acquiring certain infections.~     These infections include those caused by a bacterium called the pneumococcus which can cause~     pneumonia, meningitis and ear infections. In the UK older children with diabetes are given a~     vaccine against the pneumococcus bug called Pneumovax (or PPS23 for short). Although PPS23~     causes a good immune response in children over 2 years of age it is not actually known how~     well PPS23 protects against infection in children of any age. In addition there is some data~     in adults and children that PPS23 may result in a reduced response to future doses of~     pneumococcal vaccines (hyporesponsiveness). Because of the lack of information on how well~     PPS23 protects and potential hyporesponsiveness the investigators would like to study the use~     of an alternative vaccine against pneumococcus called Prevenar13 (or pCV13). This vaccine is~     known to be safe and to work well in babies and young children and there have been no~     concerns about hyporesponsiveness. It has been approved for use in children up to 17 years of~     age but there is little information on the size and duration of immune response to PCV13 in~     children aged 6 years and older.~   "
124376|NCT01939509|"~     At hemodynamic level, the greater affinity of bisoprolol by the beta 1 receptor in theory~     could improve the peripheral arterial perfusion and could have a greater antihypertensive~     effect. At the same time, this could carry objectifiable improvements in the vascular tree,~     such as the level of arterial stiffness.~      This study attempts to mark the hemodynamic differences in the same individual with~     hypertension and metabolic syndrome who will be exposed to both drugs at different moments.~     Parameters will be objectified with impedance cardiography, pulse wave velocity and central~     blood pressure assessment before and after taking each one of the drugs. The results will be~     compared to the baseline data and between themselves.~   "
124377|NCT01939496|"~     The purpose of this study is to evaluate the effect of canagliflozin (JNJ-28431754) on blood~     pressure reduction, compared to placebo, in patients with hypertension and type 2 diabetes~     mellitus and who are on stable doses of anti-hyperglycemic and anti-hypertensive agents.~     Overall safety and tolerability of canagliflozin will be assessed.~   "
124378|NCT01939483|"~     This pilot clinical trial studies irinotecan hydrochloride in treating patients with breast~     cancer and brain metastases that progressed after whole brain radiation therapy or~     stereotactic radiosurgery. Drugs used in chemotherapy, such as irinotecan hydrochloride, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing.~   "
124379|NCT01939470|"~     Native American women may be considered high risk for osteoporosis due to lifestyle factors~     and incidence of type 2 diabetes. The objectives of this study are to: 1) determine the~     prevalence of osteopenia/osteoporosis in Native American female volunteers; 2) to evaluate~     their rate of bone loss; 3) to assess the relationship between lifestyle factors,~     inflammatory mediators, and select endocrine parameters on osteoporosis risk; and 4)~     determine the barriers to treatment. Participants will undergo a baseline, Year 1 and Year 2~     follow-up osteoporosis risk assessment. Data will be analyzed using repeated measures ANOVA~     and logistical regression.~   "
124380|NCT01939457|"~     Women presenting with incomplete abortion and eligible for treatment with misoprostol were~     offered 400mcg sublingual misoprostol for treatment. Based on existing literature, the study~     hypothesises that women can successfully be treated with misoprostol alone as first line~     treatment.~   "
124381|NCT01939444|"~     The overall is aim of this pilot study is to give a preliminary estimation of key parameters~     of the pharmacokinetics of a proper formulation of intranasal naloxone. These data will be~     used to design a well justified protocol for the final estimation of these parameters:~        -  Preliminary estimation of bioavailability of this intranasal naloxone in human, healthy~          volunteers~        -  Preliminary estimation of the maximum serum concentration (Cmax) of this formulation~        -  Preliminary estimation of the time to maximum serum concentration (Tmax) of this~          formulation~        -  Safety of the formulation~   "
124382|NCT01939431|"~     Background:~      - Podoconiosis is a disease of the lymph vessels in the legs and feet. It is caused by~     long-term barefoot exposure to irritant soils, such as those in volcanic areas. It causes~     severe swelling and disfigurement, as well as infection and chronic pain. It mostly affects~     people who live in tropical Africa, Central and South America, and India. The reasons why~     some people develop this disease and others do not is not well understood. Researchers want~     to study people with the disease and healthy volunteers in Ethiopia. They will collect skin~     and blood samples to study genetic and other aspects of the disease.~      Objectives:~      - To collect skin and blood samples to study genetic and other aspects of podoconiosis.~      Eligibility:~        -  Individuals at least 18 years of age who have podoconiosis (early stage or advanced~          stage).~        -  Healthy volunteers at least 18 years of age.~        -  Participants will be recruited from a study clinic and hospital in Ethiopia.~      Design:~        -  Participants will be screened with a physical exam and medical history.~        -  Blood samples will be collected. A skin biopsy will be performed to collect tissue for~          study. People who have podoconiosis will provide affected and unaffected tissue. Healthy~          volunteers will provide a single skin biopsy sample.~        -  Treatment will not be provided as part of this study.~   "
124383|NCT01939418|"~     This study consists of two parts. In a phase Ib part, investigators will explore the~     recommended dose of gemcitabine, cisplatin, and RAD001 combination in patients with~     metastatic TNBC. After completing the phase Ib part, investigators will review the data and~     discuss with Novartis before the start of a phase II part. In the phase II part,~     investigators will compare the efficacy of the gemcitabine and cisplatin with or without~     RAD001 in patients with metastatic TNBC.~   "
124398|NCT01939223|"~     To evaluate and compare the efficacy and safety of regorafenib versus placebo in subjects~     with colorectal cancer (CRC) after curative resection of liver metastasis and completion of~     all planned chemotherapy.~   "
124384|NCT01939405|"~     The study aims are to develop and test the feasibility of a pediatric physical activity~     intervention that incorporates personal information on use of the built environment, and test~     the intervention's preliminary efficacy at increasing physical activity. The investigators~     hypothesize that it will be feasible to incorporate and measure changes in empiric GIS~     (geographic information system), GPS (global positioning system), and accelerometer feedback~     in the office setting as demonstrated by: i) Completeness of GPS and accelerometer data~     collection (primary measure of feasibility), ii) Participation rates among adolescents in the~     intervention group compared to the control group, and iii) Acceptability to patients as~     measured by adolescent satisfaction.~   "
124385|NCT01939392|"~     This is a global, multi-center, prospective, randomized, controlled study of the safety and~     effectiveness of renal denervation with the OneShot Renal Denervation System in patients with~     uncontrolled hypertension.~   "
124386|NCT01939379|"~     The purpose of this study is that an adductor canal nerve block (putting numbing medicine~     near the nerve) has been shown to produce excellent pain relief with less pain medication use~     after knee replacement surgery.The investigators will be comparing the amount of pain relief~     following knee replacement surgery when you have a nerve block in place. There will be~     approximately 66 subjects participating in this study. After surgery subjects will receive~     numbing medication every 6 hours for 48 hours. Subjects will also receive a morphine PCA~     (patient controlled analgesia) after surgery and pain medication by mouth every 4 hours~     around the clock with the option to receive more pain medication if needed. Subjects will~     participate in the study up to 3 days.~   "
124387|NCT01939366|"~     The purpose of this trial is to evaluate if cebranopadol is safe and can decrease pain in~     patients when compared to placebo (a tablet that does not contain active product) and when~     compared to a marketed product containing pregabalin (Lyrica®, indicated for your pain~     condition). Furthermore, this trial will be undertaken to find out if the patient's general~     health and well-being improves under trial treatment.~      The concentrations of cebranopadol in the blood will be investigated to get a better~     understanding of how it is absorbed from the gut, distributed and broken down in the body,~     and eliminated from the body.~   "
124388|NCT01939353|"~     This is a Phase 2 exploratory study being conducted to evaluate the efficacy and safety of~     EB-1020 SR in treating adult male patients who meet DSM-IV-TR diagnostic criteria for ADHD on~     the M.I.N.I.-Plus. Evaluations include determining an effectiveness signal for ADHD and~     related symptoms and exploring dosing, tolerability, onset of action, and duration of effect.~     Dose-response/tolerability relationships with EB-1020 SR will also be explored. The 1-week~     placebo lead-in also will be used for informal safety comparison purposes.~   "
124389|NCT01939340|"~     Cachexia and low nutritional intake are a common phenomena in cancer patients undergoing~     chemotherapy. The purpose of this study is to assess prevalence of cachexia and low~     nutritional intake and the impact on quality of life, fatigue and mortality in patients~     undergoing chemotherapy. Furthermore interactions between these parameters, tumor disease and~     chemotherapy, respectively.~   "
124390|NCT01939327|"~     The incidence of non-Hodgkin's lymphoma (NHL) is steadily increasing worldwide. At present,~     it is the sixth most commonly diagnosed cancer in France, with 10 000 estimated new cases and~     5200 deaths annually. An increasing NHL incidence at a rate of 3-4% per year was observed for~     the 1970s and 1980s. This stabilized in the 1990s, nevertheless still with an annual rise of~     1-2%, resulting in almost a doubling of the NHL incidence during last 40 years. This rise has~     been noted worldwide, particularly in elderly persons >55 years. Increases in high-grade NHL~     and extranodal disease are predominant. There is about 80% of B-cell histology, approximately~     90% of follicular lymphomas and about 70% of aggressive lymphoma patients present with~     disseminated disease at diagnosis. The prognosis of NHL depends on the histological type,~     stage and treatment. Indolent lymphomas have a relatively good prognosis with survival time~     as long as 10 years, but they are usually incurable in advanced stages. Aggressive NHL~     constitutes about 50% of all cases of NHL in Western Europe. Approximately 50 - 60% of these~     patients can be cured with immuno-chemotherapy regiments. Subsequently, almost 50% of~     patients will eventually relapse or become refractory to treatment. The prognosis for~     patients with refractory or relapsed aggressive NHL is generally poor. The response rates to~     salvage therapy regimens range from 20 to 40%. Patients who present with refractory disease~     have the worst prognosis, with a median survival of less than six months. Only a minority of~     patients can be given high dose chemotherapy, the majority being ineligible due to disease~     progression.~      By modulating the immune system through dendritic cells and NK cells, by changing the~     cytokine milieu, and by their anti-angiogenic effects, IMiDs in combination with mabthera~     (rituximab) resulted in augmented in vitro and vivo antitumor effects against B-cell~     lymphoma.~      As concerns the timing of administration and doses of medications, phase I/II studies are~     ongoing with R-CHOP in combination with Revlimid (Lenalidomide) in DLBCL. The latest~     presentation is by Nowakowski et al. at ASCO meeting in June 2010. This study determined the~     maximum tolerated dose of Revlimid(Lenalidomide)administered on days 1-10 with standard~     R-CHOP (R2-CHOP). NO DLT was found and 25 mg of Revlimid(Lenalidomide)was the recommended~     dose for phase II with enrollment of 32 patients. These encouraging results permit to~     introduce in our much less toxic protocol 25 mg of Revlimid(Lenalidomide)as initial dose,~     with progressive reduction in case of toxicity.~      As regards the dose and timing of Mabthera(Rituximab), in DLBCL it was traditionally used as~     a single 375 mg/m2 injection/cycle. Pre-clinical data suggests that for the optimal NK~     enhancement Revlimid(Lenalidomide)must be administrated several days (approx. 7 days) before~     Mabthera(Rituximab)injection. So, our protocol provides Mabthera(Rituximab)IV administration~     at day 7 of Revlimid(Lenalidomide).~      Performed parallel biological investigation of NK status will permit to confirm this~     hypothesis with possible correction of timing and number of administrations of~     Mabthera(Rituximab)par cycle.~   "
124391|NCT01939314|"~     The primary objective of this study is to evaluate the efficacy of sphenopalatine nerve block~     utilizing the Tx360 (device) to deliver an anesthetic agent (bupivacaine) and to assess the~     duration of the analgesia.~   "
124392|NCT01939301|"~     This is a randomized study to treat subjects diagnosed with pulmonary embolism with inhaled~     nitric oxide or placebo (oxygen).~   "
124393|NCT01939288|"~     What is known?~        -  Disorders of peripheral circulation result in vascular morbidity and mortality~        -  Augmentation of peripheral circulation has been shown to be of benefit in both venous~          and arterial disease~        -  The benefit of intermittent pneumatic compression is clinically well evidenced.~        -  The use of intermittent pneumatic compression is limited by compliance issues related to~          sleeve application and external power source.~      What new information will this trial contribute?~      - This evaluates the haemodynamic effect of a new electrical device for augmentation of~     peripheral circulation~   "
124394|NCT01939275|"~     This pilot clinical trial studies copper Cu 64 (64Cu) tetra-azacyclododecanetetra-acetic acid~     (DOTA)-trastuzumab positron emission tomography (PET)/computed tomography (CT) in studying~     patients with gastric, or stomach cancer. Diagnostic procedures, such as copper Cu~     64-DOTA-trastuzumab PET/CT, may help doctors study the characteristics of tumors and choose~     the best treatment.~   "
124395|NCT01939262|"~     Patients will be randomized into the control or intervention group. Based on patient~     preference, the intervention group will be trained for one hour in either individual or group~     format on vegan diet. They will also be directed to www.pcrm.org and www.drmarymd.com for low~     glycemic, animal free, low fat food options and support. The control group will continue~     their normal omnivorous diet program. Twenty-four hour food recalls will be obtained at the~     start and end of the trial, and once a week for the 6 weeks of the trial by telephone.~     Patients will undergo a final interview at the end of the 6 week study period. The~     intervention group should strive to obtain 90% of their calories from plants. They will be~     encouraged to eat freely and not count calories. Patients will undergo additional individual~     consultation as needed to promote compliance and answer specific questions.~      Over the 6 weeks, the Patient Global Improvement of Change (PGIC) and the 36 item short form~     health survey (SF-36) will be performed weekly by telephone. Patient will perform a Visual~     Analog Scale (VAS) of their pain level randomly daily on their own. C-reactive protein levels~     will be assessed at the beginning and end of the study at Munson Medical Center Laboratories~     as a secondary measure of diet changes.~      There have been no published prospective randomized controlled trials assessing whether a~     vegan diet would benefit osteoarthritis. The specific aim of this study is to determine if a~     vegan diet will result in subjective reduction in perceived pain and limitations to function~     in patients with osteoarthritis.~   "
124396|NCT01939249|"~     BIOFLOW-IV is a prospective, international, multicenter, randomised controlled trial. The~     purpose of this trial is to compare the Biotronik Orsiro drug eluting stent system with the~     Xience Prime / Xience Xpedition (Xience)drug eluting stent system in de novo coronary~     lesions. The study is powered for non-inferiority with respect to Target Vessel~     Failure(TVF)at 12 months.~   "
124397|NCT01939236|"~     The purpose of this study is to determine whether traditional Chinese medicine as~     complementary treatment is safe and effective in the treatment of chronic heart failure.~   "
124399|NCT01939210|"~     This randomized pilot clinical trial studies the effects of meditation-based breathing~     training on patients' control of their breathing patterns and breathing-related movement, as~     well as on their psychological distress and treatment experience during radiation therapy.~     Meditation-based breathing training may decrease breathing-related movement and the amount of~     stress by improving breathing patterns in patients with abdominal or lung cancer undergoing~     radiation therapy.~   "
124400|NCT01939197|"~     The primary objectives of this study are to assess the safety of ABT-450/r/ABT-267 with and~     without ABT-333 coadministered with and without ribavirin (RBV) for 12 and 24 weeks in HCV~     GT1- or 4-infected participants with HIV-1 coinfection and to evaluate the percentage of~     subjects achieving HCV ribonucleic acid (RNA) < lower limit of quantification (LLOQ) 12 weeks~     following treatment.~   "
124401|NCT01939184|"~     The purpose of this study is to evaluate the safety and efficacy of various fixed daily doses~     of WC3055 compared with placebo for the treatment of subjects with LUTS secondary to BPH.~   "
124402|NCT01939171|"~     To determine the efficacy and Security of Thymoglobuline in cadaveric donor Efficacy: To~     demonstrate that in cadaveric donor, Thymoglobuline diminished graft alloreactivity by~     decreasing expression of inflammatory markers in graft biopsies Security:To demonstrate that~     the administration of Thymoglobulin does not have side effects in renal recipients.~   "
124403|NCT01939158|"~     The purpose of this study is to compare the immediate and long term (up to 5 years)~     immunogenicity and safety of GSK Biologicals' MenACWY-TT vaccine when given as a single dose~     or as 2 doses to toddlers aged 12 to 14 months. Also, this study will also assess if~     co-administration of GSK Biologicals' MenACWY-TT with the booster dose of Pfizer's Prevenar~     13 adversely impacts the immunogenicity of either of the vaccines.~   "
124404|NCT01939145|"~     This is a prospective, randomized trial comparing the outcomes for Prontosan versus normal~     saline as the solution for negative pressure wound therapy with instillation (NWPTi).~     Negative pressure wound therapy (NPWT) is a well established method of treatment for acute~     and chronic wounds. The combination of negative pressure with instillation of a solution is a~     relatively novel concept that has gained popularity and is currently used nationally and~     internationally. NPWTi is the standard of care for our division. Despite the growing use,~     there is limited information regarding the selection of the ideal instillation solution. This~     is a single site, investigator initiated, NPWTi study comparing the use of Prontosan with~     normal saline for the adjunctive treatment of the acutely infected wound that requires~     hospital admission. A total of 100 subjects will be included with 50 subjects in each~     treatment arm. The outcomes that will be measured are 1) number of operations, 2) length of~     hospital stay, 3) % of wounds closed prior to discharge, 4) time to closure prior to~     discharge, 5)% remained closed at 30 day follow-up, and 6) reduction of qualitative bacterial~     cultures. The results from this study will better characterize the most appropriate use of~     NPWTi.~   "
124405|NCT01939132|"~     Psoriatic arthritis is a heterogeneous chronic inflammatory disorder involving joints, tendon~     sheaths, entheses, and the axial skeleton as well as skin and nails. This is an open-label~     trial with H.P. Acthar Gel (80 units/1mL) Subcutaneous injection administered twice weekly.~     To evaluate the signs and symptoms of psoriatic arthritis after 12 weeks, including American~     College of Rheumatology 20,Clinical Disease Activity Index, Disease Activity Index 28,~     Dactylitis and adverse events.~   "
124406|NCT01939119|"~     The purpose of this study is to examine the body-fluid balance in patients with retinal~     vascular occlusion and the influence of drinking habits and hemodilution on the degree of~     body hydration.~   "
124407|NCT01939106|"~     To assess the safety and performance of an enhanced one piece drainable pouch in subjects~     with an ileostomy.~   "
124408|NCT01939093|"~     The aims of this study are to compare the antipsychotic and adverse events of quetiapine, an~     atypical antipsychotic drug, to haloperidol, a standard treatment for primary psychotic~     disorder, in individuals with MAP.~   "
124409|NCT01939080|"~     Many conditions and cardiovascular diseases (including stroke) are better managed with~     regular exercise training. The expected effects are partial reversal of adverse effects on~     heart and blood vessel structure and function, improved glycemic, tension and weight control.~      Physiologically, the aorta maintains low left ventricular after-load, promotes optimal~     sub-endocardial coronary blood flow, and transforms pulsatile into laminar blood flow.~     Increased aortic stiffness may ultimately contribute to left ventricular dysfunction. Regular~     exercise training is likely to decrease the pulse wave velocity (a measure of the aortic~     compliance). Some subjects seem more responsive than others, and they may not expect the same~     benefit of exercise training. To the best of our knowledge, this has not been explained yet.~   "
124410|NCT01939067|"~     This study is designed to evaluate the effect of heated humidified high flow nasal cannula~     (HHHFNC) as compared to noninvasive nasal continuous positive airway pressure (NCPAP) on lung~     function as a measure of lung injury in preterm infants born at 28 to 37 weeks gestation~     requiring continuing respiratory support.~   "
124411|NCT01939054|"~     Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in~     the extra cellular domain of the human epidermal growth factor receptor (EGFR), inhibiting~     tyrosine kinase activation. This is a randomized, controlled, open-Label, multicenter, phase~     Ⅱ clinical trial of nimotuzumab plus Docetaxel and Capecitabine（TX）versus Docetaxel and~     Capecitabine（TX）as first-line treatment in patients with recurrent/metastatic triple negative~     breast cancer.~   "
124412|NCT01939041|"~     Robot-assisted training (RT) devices developed to date have a significant impact on stroke~     rehabilitation. Several research groups have developed the robotic devices and examined their~     efficacy on improving UL function after stroke. All these robotic devices have been applied~     in stroke rehabilitation and their efficacy are evaluated, but the scientific evidence for~     the mechanisms of RT-induced recovery, the relative treatment effects of unilateral vs~     bilateral robotic trainings, and the impact on physiological responses is still lacking.~      The primary purposes of this study are to examine (1) the relative immediate treatment~     effects of unilateral vs bilateral RT on motor impairments/performance and daily functions in~     patients with subacute stroke; (2) the long-term benefits of unilateral vs bilateral RT by~     conducting a 6-month follow up evaluation; and (3) the effects of RT on movement~     reorganization as well as on the physiological markers of inflammation, oxidative stress,~     erythrocyte deformability, and blood glucose. These overall findings will help better~     understanding of the efficacy of RT on functional outcomes, movement reorganization, and~     physiological markers. The investigators would additionally explore the possible differential~     treatment effects in patients with different levels of motor severity (i.e., moderate vs.~     severe).~      The investigators hypothesize that (1) both unilateral (the InMotion3) and bilateral (the~     Bi-Manu-Track) robot-assisted training would bring larger benefits on motor performance and~     daily function than the control treatment; (2) such benefits would retain during the~     follow-up; (3) there would be differential immediate and retention effects of unilateral (the~     InMotion3) and bilateral (the Bi-Manu-Track) robot-assisted training on different outcome~     measures; (4) better movement reorganization as well as physiological marker expressions~     would be found in both robotic groups compared to control group; and (5) there would be~     differential effects of robotic therapy between participants with moderate vs. severe motor~     impairment.~   "
124414|NCT01939015|"~     -  The aim of this study is to compare the standard and 3D miniplates fixation in~          mandibular angle fractures regarding to wound dehiscence, infection, nonunion, pain,~          hypoesthesia, and malocclusion. and to analyze advantages and disadvantages of one~          method over the other.~        -  Radiographic follow-up (in the form of posteroanterior and panoramic radiographs) will~          used to evaluate the patients immediately and 2 and 4 months postoperatively. Patients~          returned 7 days after surgery for clinical evaluation . The patients will be examined~          radiographically for accuracy of the reduction, screw positioning, adverse reactions in~          the vicinity of screw placement, and bone healing. the complications encountered will be~          recorded and treated. The clinical evaluations will be performed by 1 surgeon at each~          institution.~        -  The patients will also evaluated clinically for infection, nonunion, pain, hypoesthesia,~          and malocclusion. Malocclusion will assessed based on patient complaints. Criteria for~          infection will based on either of the following conditions: 1) purulent discharge from~          an incision and 2) serosanguineous drainage and a wound culture positive for a known~          pathogen. All the patients will evaluated postoperatively by a single assessor.~        -  Statically analysis :~      Student's t test will be used to compare 3D and Champy's miniplate fixation. A value of P ≤~     0.05 will be considered statistically significant.~   "
124415|NCT01939002|"~     The primary objective of this study is to determine the proportion of participants with~     relapsing multiple sclerosis who experience new and/or increased flu-like symptoms (FLS)~     after transitioning from nonpegylated IFN-β therapies to peginterferon beta-1a (BIIB017).~      Secondary objectives are: to determine the severity and frequency (measured by flu-like~     symptom score [FLS-S]) of FLS in these participants; to determine the duration (measured in~     number of hours) of FLS in these participants; to determine the effect of BIIB017 on other~     participant-reported outcomes, including treatment satisfaction (measured with the Treatment~     Satisfaction Questionnaire for Medication [TSQM]) and disability status (measured with the~     Patient Determined Disease Steps [PDDS]) over a 56-week period; to determine whether~     interferon-related FLS result in missed days of work/daily activities (e.g., absenteeism); to~     assess the use of additional medications (in addition to current medications used to treat~     FLS) to relieve BIIB017-related FLS; to determine the incidence of adverse events throughout~     the study period; to characterize the immunogenicity profiles of participants switching from~     prior IFN-β therapy to BIIB017.~   "
124416|NCT01938989|"~     The purpose of this study is to evaluate photostress recovery with blue light filter clip-on~     glasses among pseudophakes [ie, subjects in which the natural lens of the eye has been~     replaced with an artificial lens (intraocular lens) during cataract surgery]. This study will~     enroll subjects previously implanted with no blue light filter intraocular lenses (IOLs) for~     at least 3 months.~   "
124417|NCT01938976|"~     Study Hypotheses:~        1. adolescents in intervention schools who are given Triple A program plus ASP will show~          more awareness in regards to cigarettee smoking health effects and less nicotine~          dependencethan those in the control schools who are given Triple A alone.~        2. adolescents with asthma in intervention schools who are given Triple A program plus ASP~          will show less asthma symptoms and better control than those in the control schools who~          are given Triple A alone.~        3. adolescent smokers and passive smokers will exhibit higher levels of carbon monoxide~          (CO) in their breath than those who are not active or passive smokers.~        4. there is a positive correlation between self-report questions regarding student smoking~          status and levels of CO in their breath~   "
124418|NCT01938963|"~     This study will see if education of village doctors and aging workers in identification and~     management of hypertension and depression, using standardized procedures,consultation with a~     psychiatrist as needed, and collaborations between the village doctor and aging worker in~     care elderly patients in the village better achieve better outcomes for their depression and~     high blood pressure than usual care.~   "
124419|NCT01938950|"~     The current epidemic rate of childhood obesity is a leading health concern as~     overweight/obese youth may suffer from comorbid conditions, once considered exclusive to~     adults. It has been suggested that physical inactivity is a major determinant of obesity and~     obesity-related health risk in children and adolescents. Recent studies in adults report that~     the combination of aerobic and resistance exercise is a better strategy than aerobic or~     resistance exercise alone for reducing risk factors for type 2 diabetes. Currently, the most~     effective exercise modality for concurrent reductions of adiposity, in particular abdominal~     fat, and risk factors for type 2 diabetes and cardiovascular disease (CVD) is unknown in~     adolescents. Therefore, we will employ a randomized trial to examine the effects of a~     long-term aerobic exercise, resistance exercise, and a combination of both exercise regimens~     on: 1) in vivo insulin sensitivity, glucose tolerance and risk for type 2 diabetes, 2) total~     adiposity, skeletal muscle mass, visceral adiposity and ectopic fat in the liver and skeletal~     muscle, and 3) traditional and non-traditional risk factors/markers for CVD in overweight~     boys and girls. We will recruit 168 sedentary overweight (BMI >85th percentile) adolescent~     boys and girls aged 12-17 years old and randomly assign them to one of three 6-month~     intervention groups (n = 56 each group): 1) aerobic exercise (180 min/week), 2) resistance~     exercise (180 min/week), or 3) aerobic and resistance exercise (180 min/week) group. A weight~     maintenance diet (55-60% carbohydrate, 15-20% protein, and 25-30% fat) will be prescribed and~     monitored for all groups, so that any changes in energy balance will be induced by exercise~     intervention alone (e.g., no calorie restriction). We believe that this proposed application~     will have a significant implication that is directly relevant for one in three American~     adolescents who are at increased risk of developing obesity-related co-morbidities.~   "
124420|NCT01938937|"~     The purpose of this study is to determine if transcranially administered bright light has~     acute effect on anxiety symptoms.~   "
124421|NCT01938924|"~     A study to investigate if the gekoTM device improves flow through vascular bypass grafts~   "
124422|NCT01938911|"~     To test a psychopharmacological intervention strategy which may provide new insights into the~     mechanisms underlying the physiological hyperreactivity to stress observed in hypertension,~     we plan to test the effects of the neuropeptide oxytocin and social support on the~     neurobiological and psychological responsiveness to social stress. The study population for~     this project consists of 80 hypertensive and 80 normotensive non-smoking medication-free men.~     We expect exogenous oxytocin administration to enable hypertensives to effectively take~     advantage of the provided social support. Thereby, oxytocin may enhance the effect of social~     support on reducing the previously observed physiological hyperreactivity to stress in~     essential hypertensives.~   "
124493|NCT01937975|"~     Grazoprevir (MK-5172) and Elbasvir (MK-8742) were studied as the principal components of~     combination oral therapy for hepatitis C virus (HCV). The study examined the pharmacokinetic~     (PK) profiles of Grazoprevir and Elbasvir following 10 days of dosing in participants with~     end stage renal disease (ESRD) on hemodialysis (HD) or participants with severe renal~     impairment. Both groups were compared to healthy matched controls.~   "
124423|NCT01938898|"~     The Northern Ireland Cohort for the Longitudinal Study of Ageing (NICOLA) is an opportunity~     to conduct methodology research relevant to many features of a large prospective study.~     NICOLA will begin in earnest in Northern Ireland in 2013 and is being conducted by a~     multidisciplinary team in the Centre for Public Health at Queen's University Belfast. It is~     an omnibus programme of research on ageing that will continue for at least 10 years and will~     recruit 8500 middle-aged people in Northern Ireland and follow them into old age, providing a~     comprehensive assessment of their physical and mental health, their lifestyles, and their~     social and economic decision making. NICOLA will look at how they perceive disability and~     health, and how this differs between well-off and disadvantaged groups. NICOLA will also~     study various genetic, biological and psychological factors, including how participants~     perceive risk and value their time, and the effect of this on their retirement behaviour~     (including how they manage their money and their health). People over the age of 50 will be~     invited to take part and asked to complete detailed interviews and questionnaires every 2~     years and health assessments every 4 years.~      The overall aim of this research is to examine the impact of differing invitation letters~     offered to participants on study recruitment rates.~   "
124424|NCT01938885|"~     Hepatic pseudoaneurysm (HPA) is a rare complication after liver trauma, yet it is potentially~     fatal, as it can lead to sudden severe haemorrhage. The risk of developing posttraumatic~     hepatic pseudoaneurysm is one of the reasons why some trauma centres do follow-up CT of~     patients with liver injuries to take the therapeutic consequence. The aim of this study was~     to investigate the occurrence of HPA post liver trauma.~   "
124425|NCT01938872|"~     to evaluate the the effectiveness of paclitaxel-eluting balloon for below-the-knee~     angioplasty in terms of restenosis at 12 months~   "
124426|NCT01938859|"~     The purpose of the AGTs-BD study is to compare the treatment outcome and safety profiles~     between different mood stabilizers combination treatments in the patients with bipolar~     disorders, currently suffered from depression episode.~   "
124427|NCT01938846|"~     The primary objective of the trial is to determine the maximum tolerated doses (MTD) of BI~     860585 alone and in combination with exemestane or paclitaxel. To determine the MTDs,~     patients are entered sequentially into escalating dose cohorts. Secondary objectives are~     objective response and disease control according to RECIST criteria version 1.1~   "
124428|NCT01938833|"~     This phase I/II trial studies the side effects and best dose of romidepsin when given~     together with paclitaxel albumin-stabilized nanoparticle formulation and to see how well they~     work in treating patients with metastatic inflammatory breast cancer. Romidepsin may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving romidepsin and paclitaxel albumin-stabilized nanoparticle~     formulation may be an effective treatment for inflammatory breast cancer.~   "
124429|NCT01938820|"~     Patients with chronic hepatitis B histologically confirmed of early cirrhosis S4 (similar to~     metavir F4, Ishak 5/6) are randomly assigned in a 1:1 ratio. One arm is entecavir alone for 2~     years; the other is entecavir for the first 0.5 year, entecavir plus thymosin for 1 year,~     entecavir for another additional 0.5 year. Patients will be assessed at baseline, at every~     six months for blood count, liver function test, HBVDNA, AFP, prothrombin time, liver~     ultrasonography, and Fibroscan. The second liver biopsy will be performed to evaluate~     regression rate of liver fibrosis 1.5 years after initial therapy.~   "
124430|NCT01938807|"~     Despite multidisciplinary care and advancements in therapeutics and technology, health~     outcomes remain suboptimal in pediatric diabetes centers world-wide. A major contributor to~     poor outcomes is suboptimal diabetes management in pediatric patients and their families. The~     premise of this research project is that patients and families do not have adequate resources~     to meet the level of diabetes management that translates to better outcomes. Therefore, we~     will give them a valuable tool to improve their overall management. The tool is CareCoach.~      Research shows that enhancing communication and partnership among patients, parents, and~     providers is especially critical for optimal outcomes in pediatric diabetes. Communication~     gaps and conflict can complicate the already complex provider-patient interactions and daily~     management. We have therefore designed, refined, and made available to consumers a new~     mobile-based intervention, CareCoach, to improve communication; build trust among providers,~     patients and parents; and increase overall satisfaction with the quality of diabetes care.~     This web/mobile application is designed to help patients unobtrusively audiorecord their~     clinical encounters, track their medical consults and treatment plans, review information~     from past visits, create visit discussion guides, and track adherence to medication and~     dosing schedules. In addition, because mobile-based applications are inexpensive to~     administer, portable, and available at all times of day, CareCoach holds great promise for~     communication coaching and contributing to improved diabetes management.~      We hypothesize that CareCoach will improve patient-parent-provider communications, build~     patient-parent-provider trust, and increase overall satisfaction with clinical interactions~     in a sample of children with type 1 diabetes and their parents. These improvements will lead~     to significant gains in diabetes management, setting the stage for optimal health outcomes.~     To test the effectiveness of CareCoach, we will conduct a randomized controlled trial~     comparing the CareCoach intervention to standard care in a sample of 60 children with type 1~     diabetes and their parents.~   "
124431|NCT01938794|"~     Accurately measuring how many calories a person burns each day is difficult to do.~     Researchers can do this with a technique called doubly labeled water (DLW). This involves~     drinking water that is labeled with a non-radioactive tracer. After a few hours, the~     labeled water can be detected in the urine. To measure how many calories are burned (Total~     daily energy expenditure, TDEE), urine samples are collected several days apart. Although~     this technique is accurate, it is also challenging for two reasons. First, the labeled water~     is expensive. Second, the urine samples are analyzed using equipment (Isotope Ratio Mass~     Spectrometer, or IRMS) that is expensive and difficult to operate. The goal of this project~     is to develop a new instrument to perform DLW measurements of TDEE. This instrument, called a~     triple isotope water analyzer (TIWA) is less expensive and easier to operate than IRMS.~     Additionally, since the TIWA is more accurate than IRMS, it may potentially reduce the amount~     of labeled water required to measure TDEE, and thus reduce costs. The purpose of this study~     is to compare the accuracy of measuring TDEE from labeled water using the new instrument~     (TIWA) and from the traditional approach (IRMS). We will also compare the accuracy to the~     measurement of TDEE from whole-room indirect calorimetry (metabolic room), which is~     considered the most accurate way to measure TDEE.~   "
124442|NCT01938638|"~     The purpose of this study Part A is to determine the safety, tolerability and the~     pharmacokinetics of BAY1143572 in subjects with advanced malignancies, which are either~     refractory to or ineligible for treatment with standard agents.~      The purpose of this study Part B is:~      Determine the safety, tolerability, pharmacokinetics (PK) and maximum tolerated dose~     (MTDG-CSF) of BAY1143572 with concurrent administration of the granulocyte colony-stimulating~     factors (G-CSF) in an intermittent and continuous dosing schedule in subjects with advanced~     malignancies.~   "
124432|NCT01938781|"~     Patients with chronic hepatitis B histologically confirmed of liver fibrosis S2/S3 (similar~     to metavir F2/F3, Ishak 2/3/4) are randomly assigned in a 1:1 ratio. One arm is entecavir~     alone for 2 years; the other is entecavir alone for the first 0.5 year, entecavir plus~     pegylated interferon (peg-IFN) for 1 year, entecavir for another additional 0.5 year.~     Patients will be assessed at baseline, at every six months for blood count, liver function~     test, HBVDNA, AFP, prothrombin time, thyroid function, liver ultrasonography, and Fibroscan.~     The second liver biopsy will be performed to evaluate regression rate of liver fibrosis 1.5~     years after initial therapy.~   "
124433|NCT01938768|"~     Severe external and internal bleedings are common in multiple trauma patients. Uncontrollable~     blood loss is the cause for about one third of all trauma deaths. A number of blood clotting~     mechanisms are known to be triggered by major blood losses. These mechanisms shall secure the~     organisms from loosing even more blood. To avoid an overshooting clotting behavior,~     inhibiting mechanisms occur as well. An important inhibiting (or fibrinolytic) mechanism is~     the fibrinolysis that is based on the conversion of plasminogen to plasmin. In severe~     bleeding situations this mechanism tends to overshoot and therewith contributes to the~     severity of the bleeding. This phenomena is called hyperfibrinolysis and is found in~     approximately one third of all multiple trauma patients. Mortality rates are increased in~     these patients. Tranexamic acid is an antifibrinolytic drug that inhibits the conversion from~     plasminogen to plasmin and therefore is able to limit the effects hyperfibrinolysis. A large~     study showed positive influence of tranexamic acid on mortality rates and blood loss in~     severely injured patients, when it was administered in an early clinical setting. In this~     study we want to answer the question wether a hyperfibrinolysis can be seen in an early~     prehospital (on the scene) setting and how it is influenced by an early prehospital~     administration of tranexamic acid.~   "
124434|NCT01938755|"~     Spinal anaesthesia also called spinal block or sub-arachnoid block (SAB), is a form of~     regional anaesthesia involving injection of a local anaesthetic into the subarachnoid space,~     generally through a fine needle.~      There is no generic hyperbaric form of levobupivacaine currently available so we aimed in~     this study that to find the appropriate concentration of the levobupivacaine which achieves~     unilateral spinal anesthesia. The potential benefits of this type of anesthesia are less~     motor blockade and urinary retention, decrease in hospital stay. Therefore, it seems to be~     suitable for outpatient anesthesia.~   "
124435|NCT01938742|"~     This is a Phase II randomized, double-blinded, controlled study in up to 700 males and~     non-pregnant females, 19 to 64 years old, inclusive, designed to assess the safety,~     reactogenicity, and immunogenicity of a monovalent influenza A/H7N9 virus vaccine~     administered at different dosages (3.75, 7.5, or 15 mcg of HA/0.5 mL dose) given with and~     without MF59 adjuvant and without adjuvant (15 mcg of HA/0.5 mL dose and 45 mcg of HA/0.75 mL~     dose). Subjects will receive two doses via intramuscular injection, approximately 21 days~     apart. Safety, reactogenicity, and immunogenicity data will be collected at standard time~     points with safety follow-up to continue through one year post dose 2. The duration of the~     study for each subject will be approximately 13 months.~   "
124436|NCT01938729|"~     This is a Phase I study, which means we want to find out what effects, good and/or bad, this~     combination of drugs may have on the patient and the liver cancer at different dose levels.~     All patients will have an operation to remove tumors in the liver and may have a pump placed~     in their abdomen.~      On this study, both drugs given have been used in other patients for treatment of~     cholangiocarcinoma and other gastrointestinal cancers. Both drugs are approved by the food~     and drug administration (FDA) for treatment of liver cancer, but the two drugs have only been~     combined in a few patients.~      That means that in this trial we also want to find out if this combination is safe.~      The study will also evaluate if this treatment works in delaying or stopping the cancer from~     coming back after surgery.~   "
124437|NCT01938716|"~     The goal of this clinical research study is to learn if gemcitabine given during surgery can~     enter pancreas cancer cells in patients who have already received chemotherapy and radiation.~      Gemcitabine is a drug used to treat pancreatic cancer. However, it has not previously been~     studied if gemcitabine can enter pancreatic cancer cells. Gemcitabine is designed to block~     the growth of cancer cells, which may cause cancer cells to die.~   "
124438|NCT01938690|"~     Approximately two thirds of stroke survivors have profoundly impaired function of the upper~     limb. Currently the main stay of the treatment for upper limb motor function is~     rehabilitation therapy focusing on repetitive and skillful task practice (task-oriented~     therapy) which has been shown to induce substantial functional reorganization in the~     undamaged motor cortex and functional recovery. In spite of rehabilitation therapy,~     functional recovery of arm and hand function is limited to one third of stroke survivors and~     there is a great need for adjunct treatment to current practice. Repetitive Transcranial~     Magnetic Stimulation (rTMS) is a noninvasive means of stimulating nerve cells in superficial~     areas of the brain and emerging as a novel method of modulating cortical excitability and~     promoting functional recovery after stroke. There have been studies using rTMS to improve~     motor function after stroke. However, whether 1Hz rTMS can enhance the effect of the~     task-oriented therapy on upper limb function after stroke has not been investigated. In this~     pilot proposal, we intend to investigate the feasibility of 1Hz rTMS on unaffected hemisphere~     as an adjunct to task-oriented therapy to improve upper limb motor function among stroke~     patients. The information obtained from this pilot study will provide a platform for the~     future randomized control trials combining the rTMS and task-oriented therapy to enhance~     motor recovery among stroke survivors.~   "
124439|NCT01938677|"~     The effect of Gamma knife radiosurgery (GKRS) on hearing loss, in patients with vestibular~     schwannoma (VS) and preserved hearing is still unclear. Retrospective data indicate that the~     hearing is preserved in most patient years after the gamma knife treatment. Recent~     prospective data suggests that radiosurgery could be a hearing preserving treatment for these~     patients.~      The main objective of this study is to evaluate if GKRS can inhibit progression of hearing~     loss in patients with VS. Patients with preserved hearing will be offered to participate in~     the study and randomized ether to GKRS or initial conservative treatment for their vestibular~     schwannoma. They will then be followed with scheduled magnetic resonance image(MRI) and~     audiometry and evaluated after one, three and five years after treatment.~   "
124440|NCT01938664|"~     The purpose of this study is to see if a drug called Candesartan will help to reduce use of~     cocaine.~   "
124443|NCT01938625|"~     The purpose of the study is to evaluate effect of steady-state (when the amount of drug~     administered (in a given time period is equal to the amount of drug eliminated in that same~     period) of simeprevir and daclatasvir on the steady-state pharmacokinetics (what a medication~     does to the body) of cyclosporine (applicable to Part 1 only) and tacrolimus when~     administered as a combinational regimen in post-orthotopic liver transplantation (OLT)~     participants with recurrent hepatitis C virus (HCV) genotype 1b infection and effectiveness~     of a 24-week treatment regimen containing simeprevir, daclatasvir, and ribavirin (RBV) with~     respect to the proportion of HCV genotype 1b infected post-OLT participants achieving~     sustained virologic response 12 weeks after end of treatment.~   "
124444|NCT01938612|"~     This is a phase I, open-label, multicentre study of MEDI4736 administered intravenously with~     a standard 3+3 dose-escalation phase to evaluate safety, tolerability, and pharmacokinetics~     in patients with advanced solid tumor followed by an expansion phase in patients with~     advanced solid tumors.~   "
124445|NCT01938599|"~     To compare the safety and efficacy profile of AM001 Cream and its vehicle in the treatment of~     plaque psoriasis.~   "
124446|NCT01938586|"~     The purpose of this study is to compare the cosmetic outcome between buried intradermal and~     superficial cutaneous suture closures versus buried intradermal sutureand superficial~     Steri-Strip closures in the bilayered repair of dermatologic wounds on the back following~     elliptical excision of benign or malignant lesions~   "
124447|NCT01938573|"~     This phase I/II trial studies the side effects and best dose of sirolimus when given together~     with cisplatin and gemcitabine hydrochloride and to see how well they work in treating~     patients with bladder cancer. Biological therapies, such as sirolimus, may stimulate or~     suppress the immune system in different ways and stop tumor cells from growing. Drugs used in~     chemotherapy, such as cisplatin and gemcitabine hydrochloride, work in different ways to stop~     the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Giving sirolimus together with cisplatin and gemcitabine~     hydrochloride may be an effective treatment for bladder cancer.~   "
124448|NCT01938560|"~     As part of a post-marketing commitment, GSK will conduct a survey of prescribers' and~     pharmacists' understanding of the risk of urinary retention with retigabine products. This is~     to address the effectiveness of the Risk Evaluation and Mitigation Strategy (REMS) as~     outlined in the REMS approved by the FDA on 10th June 2011. The objectives of this survey are~     to assess prescribers' and pharmacists' understanding of the risk of urinary retention and~     the symptoms of acute urinary retention potentially associated with retigabine use as~     evaluated by a survey instrument.~      This is a cross-sectional study of approximately 200 physicians (e.g.~     neurologists/epileptologists/neurosurgeons) who have prescribed retigabine at least once in~     the last 12 months, and 200 pharmacists who have dispensed an anti-epileptic drug (AED) at~     least once in the last 3 months. The primary outcome of the survey is the proportion of~     physicians and pharmacists providing correct responses to a series of questions concerning~     the risk of urinary retention and the symptoms of acute urinary retention that may be~     associated with retigabine. The risks captured will be those described in the retigabine Dear~     Healthcare Provider (DHCP) letters, specifically risks of urinary retention.~   "
124449|NCT01938547|"~     To evaluate the efficacy, safety and dosing of an intravenous (IV) infusion of clevidipine~     for blood pressure (BP) management in pediatric participants in the perioperative setting.~   "
124450|NCT01938534|"~     Prospective study : Helicobacter pylori eradication therapy in accordance with past~     antibiotics use.~   "
124451|NCT01938521|"~     The aim of this study is to examine whether the chronic administration during 12 weeks of~     polyphenols contained in Red Grape Cells (RGC) powder has an effect on mRNA expression of~     SIRT1 and Clock Genes, on circulating levels of HbA1c, lipids, blood pressure and on~     postprandial response of glucose, lipids, insulin, C-peptide and GLP-1 in patients with type~     2 diabetes .~   "
124452|NCT01938508|"~     This study compared the bioavailability of two formulations 100 mg (one capsule or other~     respectively) of each one of the products, of Minocycline, under fasting conditions, in~     healthy Mexican volunteers of both sexes. The single dose study under fasting (10 hours prior~     to study) conditions, cross, with two treatments, two periods, two sequences (2x2) randomized~     sequence, balanced, and with a washout period of at least 7 days between each dose, in 24~     healthy volunteers.~   "
124453|NCT01938495|"~     The study is being conducted to determine if DPS treatment for people with ALS and~     hypoventilation is associated with improved survival or diaphragm function.~      The primary objective of the study is to conduct a multi-center, randomized controlled~     clinical trial comparing standard of care (control) to diaphragm stimulator treatment with~     the NeuRx® Diaphragm Pacing System™ (DPS) with respect to survival.~      The secondary objective of the study is to conduct a multi-center, randomized controlled~     clinical trial to compare standard of care treatment (control) to DPS in ALS subjects with~     hypoventilation.~   "
124454|NCT01938482|"~     The proposed indication for GSK1940029 is topical treatment of acne, the early clinical plan~     will evaluate the irritation potential of GSK1940029 (Study SCD117225 - 3 Part study); and~     safety, tolerability and pharmacokinetics of GSK1940029 (Study SCD117226 - 2 Part study),~     after topical administration on healthy subjects and acne patients. Study SCD117226 will be a~     randomized, single-blind, dose-rising study to evaluate the safety, tolerability and~     preliminary pharmacokinetics of single and 14 day repeat topical applications of GSK1940029~     gel on the intact skin of healthy human subjects. Part 1: (single-dose) subjects will receive~     0.3% or 1% GSK1940029 (or matching vehicle), as a single approximately (App) 24 hour (h)~     (22.5h) application to a surface area of 400 square centimeter (cm^2) (0.3%), 400 cm^2 (1%)~     or 1200 cm^2 (1%), respectively, in each of three sequential cohorts. Part 2: (repeat-dose)~     subjects will receive 0.3% or 1% GSK1940029 (or matching vehicle), as 14 daily App24h (22.5h)~     application to a surface area of 400 cm^2 (0.3%), 400 cm^2 (1%) or 1200 cm^2 (1%),~     respectively, in each of three sequential cohorts. Parts within Study SCD117225 and Study~     SCD117226 will have interdependencies. No significant primary irritation signal in Study~     SCD117225 Part 1 (primary irritation) would allow initiation of Study SCD117226 Part 1. Once~     safety, tolerability and exposure information are determined in Study SCD117226 Part 1, then~     Part 2 (cumulative irritation) of Study SCD117225 may be initiated along with Part 2 of Study~     SCD117226. No significant cumulative irritation signal (study SCD117225 Part 2) in~     combination with adequate 14-day safety (study SCD117226 Part 2) would allow initiation of~     Part 3 (facial irritation) of Study SCD117225.~   "
124456|NCT01938456|"~     The primary purpose of this study is to evaluate the safety and tolerability of the~     combination therapy of trametinib and docetaxel with growth factor support in Japanese~     subjects with Stage IV or a postoperative recurrence non-small cell lung cancer (NSCLC). This~     study data will be used for making decision for further Japanese development plan for NSCLC.~     Six evaluable subjects will be enrolled in a dose level to evaluate the safety and~     tolerability of the combination treatment. Dose-limiting toxicity will be assessed during the~     first 21 days of combination therapy.~   "
124457|NCT01938443|"~     The purpose of this study is to assess the safety of combination treatment of GSK2256098 and~     trametinib in mesothelioma subjects and subjects with other selected tumor types. Also, the~     study will identify a maximum tolerated combination dose of GSK2256098 and trametinib. This~     study is a Phase I, open-label, dose-escalation study to determine maximal tolerated dose~     (MTD) and the recommended Phase 2 dose (RP2D) and regimens for oral MEK inhibitor trametinib~     (once daily [OD]dosing) and the oral FAK inhibitor GSK2256098 (twice daily [BID] dosing). The~     synergy of the combination was observed over a wide range of concentrations and results in~     several-fold reduction in compound concentration to achieve equivalent biological responses~     compared to either single agent. The dose and schedule of dosing may be modified based on~     emerging safety, pharmacokinetic (PK), and pharmacodynamic (PD) data. The study will be~     conducted in two parts; Part 1 Dose Escalation to determine the MTD and RP2D and Part 2~     Expansion Cohort to further evaluate the safety and tolerability of trametinib and GSK2256098~     at the RP2D and determine clinical activity. Additionally, in Part 1 Dose Escalation,~     additional subjects with malignant pleural mesothelioma (MPM) will be recruited at doses that~     are considered tolerable in order to assess PD in MPM subjects at each dose (the~     Pharmacodynamic Cohort). The Expansion Cohort will be limited to subjects with MPM who have~     progressed or are intolerant to first-line therapy.~   "
124458|NCT01938430|"~     This study will evaluate ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus~     ribavirin (RBV) in participants with advanced liver disease or posttransplant and chronic~     genotype 1 or 4 hepatitis C virus (HCV) infection.~        -  Cohort A: decompensated cirrhosis (advanced liver disease), no prior liver transplant;~        -  Cohort B: post-liver transplant, with or without cirrhosis;~        -  Group assignment within cohorts is based on severity of liver impairment at screening~          (Child-Pugh-Turcotte (CPT) score for participants with cirrhosis; fibrosis; or presence~          of disease for fibrosing cholestatic hepatitis (FCH) groups)~        -  Randomization is 1:1 within groups to 12 or 24 weeks of LDV/SOF+RBV treatment.~   "
124459|NCT01938417|"~     This study aimed to assess the systemic absorption and disposition of tobramycin in patients~     treated with a tobramycin-laden bone graft substitute (Osteoset® T).~   "
124460|NCT01938404|"~     To assess and evaluate the safety of octaplas™ in comparison to standard plasma product~     (e.g., fresh frozen plasma (FFP) and other approved plasma products used within 24 hours of~     thawing) used in the treatment of TTP, in patients undergoing Therapeutic Plasma Exchange,~     with a special emphasis on the occurrence of thromboembolic events (TEEs).~   "
124461|NCT01938391|"~     IVUS imaging will be utilized to assess performance of the Sponsor's Orbital Atherectomy~     System (OAS) followed by adjunctive balloon angioplasty (BA) in patients who have symptomatic~     peripheral artery disease (PAD) occurring in the Superficial Femoral Artery (SFA), Popliteal~     (POP), and/or Tibioperoneal Trunk (TPT).~   "
124462|NCT01938378|"~     To assess the safety and tolerability of octaplas™ in the pediatric population by monitoring~     serious adverse drug reactions, adverse drug reactions (ADRs), thrombotic events (TEs),~     thromboembolic events (TEEs) and by measuring safety laboratory parameters.~   "
124463|NCT01938365|"~     primary outcome: To explore the genetic susceptibility of diabetes in Chinese adolescent and~     youth.~      secondary outcomes:~        1. To classify diabetes by gene detection in Chinese adolescent and youth.~        2. To make the relationship between genotype and clinic phenotype in type 1 diabetes.~        3. To evaluate the effect of environmental factors (intestinal ecosystem)in the~          pathogenesis of diabetes.~   "
124464|NCT01938352|"~     After prophylactic vaccination with CR8020, a monoclonal antibody, subjects will be~     challenged with the H3N2 virus. The protective efficacy, safety, tolerability,~     pharmacokinetics, and potential immunogenicity will be assessed.~   "
124465|NCT01938339|"~     To development of clinical assessment technique using multi-radiotracer positron emission~     tomography/magnetic resonance (PET/MR) in prostate cancer~        -  to establish the optimal imaging technique of PET/MR using multiple radioactive tracers~          for prostate cancer~        -  to establish the imaging biomarker using PET/MR for clinical assessment of prostate~          cancer and early detection of recurrent prostate cancer~   "
124466|NCT01938326|"~     1. Compare the immune response and postoperative complications between pure SIDG~          (single-incision laparoscopic distal gastrectomy) and TLDG (totally laparoscopic distal~          gastrectomy) for early gastric cancer (EGC)~        2. Validate the safety, usefulness, minimal invasiveness and feasibility of SIDG (EGC)~   "
124467|NCT01938313|"~     Enhanced Recovery After Surgery (ERAS) programs have been introduced with purposes of~     reducing the surgical stress response and obtaining optimal recovery after surgery.~   "
124468|NCT01938300|"~     Magnesium sulphate is given to the patients during the colorectal cancer surgery under the~     hypothesis that it would attenuate the postoperative hypercoagulability. The investigators~     intend to characterize the changes of coagulation in colorectal cancer patients by using the~     point-of-care device after the infusion of magnesium sulphate.~   "
124469|NCT01938287|"~     This study investigates the effect of eye opening/closure on the quality of IOP (intraocular~     pressure) related patterns recorded with SENSIMED Triggerfish. Each subject receives 2~     24-hour recording sessions, one with the recorded eye open and the other with the eye~     closed,using an ophthalmic patch.~   "
124470|NCT01938274|"~     To pilot test an activity-focused intervention that educates patients undergoing total hip~     (THA) or total knee (TKA) arthroplasty due to osteoarthritis about the appropriate type,~     frequency, intensity, and duration of expected leisure activities after surgery and to~     determine if the intervention changed expectations.~   "
124521|NCT01937585|"~     The purpose of this study is to determine whether female partners of African American men can~     promote initiation of a discussion with a healthcare provider about prostate cancer screening~     when the partner is supported by a print message designed to provide relevant information and~     strategies for her to use in this effort.~   "
124471|NCT01938261|"~     Present randomized, controlled, double-blind trial investigates the efficacy and safety of~     early (<24 h) intravenous paracetamol therapy for both the early closure of the ductus and~     pain medication in very small premature infants. This phase 2 drug study focuses on the~     efficacy and safety of short-term use. The pharmacokinetics and pharmacodynamics of~     paracetamol, as well as the long-term effects, are studied.~      This study recruits preterm infants born less than 32 weeks gestational age and treated at~     the neonatal intensive care unit of Oulu University Hospital. The informed consent is asked~     from all parents. The first drug dose is given before 24 hours of age. Masked study drug is~     paracetamol infusion solution 10 mg/mL (PERFALGAN ®) or placebo, 0.45% saline solution. The~     loading dose is 20 mg/kg, and the maintenance dose 7.5 mg/kg every 6 hours for 4 days. The~     exact date of the closure of ductus is studied by repeated echocardiographic examinations.~     The symptoms of pain are screened by a locally used pain scale of preterm infants (NIAPAS).~     Patients are monitored for signs of possible side effects. After discharge from hospital,~     patients are examined at follow-up clinic for the first year every 3 months and at 2 years of~     age.~   "
124472|NCT01938248|"~     This study aims to determine if treatment with apixaban, compared with aspirin, will reduce~     the risk of ischemic stroke and systemic embolism in patients with device-detected~     sub-clinical atrial fibrillation and additional risk factors for stroke.~   "
124473|NCT01938235|"~     This study aims to assess the effect of exenatide on myocardial injury in patients undergoing~     emergent percutaneous coronary intervention (PCI) for ST segment elevation myocardial~     infarction or heart attack (STEMI).~   "
124474|NCT01938222|"~     A number of studies identifies abdominal hernia as the most frequent postoperative~     complication following laparotomy with percentages of 9-20% - depending on duration of~     follow-up. It is based on a multifactorial basis, including factors concerning individual,~     patient-specific factors, factors related to the operational technique as well as particular~     surgical factors. Wound complications have been reported by 7-12%, burst abdomen rate~     (dehiscence) < 5 days being 2-4%, wound infection rate (+/- wound dehiscence) ≥ 5 days being~     6-10%. In emergency procedures (e.g. ileus, perforation of hollow organ) a wound complication~     rate of up to 50 % has to be expected. According to new, first findings from recent studies~     the rates of wound healing complication and burst abdomen can be reduced significantly.~     Depending on the study, to almost 50%. The principle is based on the reduction of the stitch~     length and type of the inserted suture. The stitches are closer and with less distance to the~     edge of fascia. Due to the much thinner suture it still comes here to a quantitative~     reduction of the inserted suture. The data collected using the MonoMax® suture in the short~     stitch technique will be compared to the results of the ISSAAC trial, in which the MonoMax®~     suture was used in the long stitch suture technique. The generated data are thus subject of~     retrospective comparison with a historical control group (ISSAAC study).~   "
124475|NCT01938209|"~     Thirty-nine patients with cervical spine pain were randomly assigned to either a seated~     thoracic manipulation or targeted supine thoracic manipulation group. Pain and flexion range~     of motion measures were taken before and after the intervention.~   "
124476|NCT01938196|"~     The purpose of this study is to evaluate the efficacy and safety of titrated KWA-0711 dose in~     chronic constipation patients.~   "
124477|NCT01938183|"~     Hypothesis: metronidazole gel applied topically after periodontal debridement in smokers~     volunteers could improve clinical parameters when compared to metronidazole tablets +~     periodontal debridement. Method: 30 smokers with chronic periodontitis were randomly assigned~     into 3 groups: periodontal debridement combined with 3 g placebo gel; periodontal debridement~     combined with daily topical application of 3 g metronidazole benzoate gel (15%); and~     periodontal debridement combined with a daily single dose of 750 mg metronidazole. Clinical~     parameters evaluated were visible plaque, gingival bleeding, probing pocket depth and~     relative attachment level.~   "
124478|NCT01938170|"~     This study will examine the feasibility of having parents and caregivers administer FluMist~     live intranasal vaccine to their children at home outside the traditional medical environment~     and without the involvement of medical personnel.~      The study will recruit patients and families that are already eligible to receive the FluMist~     vaccine. After consent is obtained and vaccine is given to the family, they will go home to~     administer vaccine to other members within 24 hours. Telephone follow up within 48 hours will~     confirm that vaccine was given successfully and within 9-12 days to assess patient~     preferences for giving vaccine at home and if there were any adverse events.~   "
124479|NCT01938157|"~     Purpose: The purpose of this pilot study is to evaluate whether MRI of the breasts with~     diffusion-weighted MR imaging can identify features more specific for breast cancer in women~     at high-risk of developing breast cancer.~      Participants: One hundred asymptomatic women at high-risk for breast cancer recommended for a~     clinical breast MRI identified through the UNC Breast Clinic will be consecutively recruited~     for this study.~      Procedures (methods): Each patient will undergo a clinical breast MRI and the addition of a~     single 90 second diffusion weighted sequence. A reader study will be conducted at UNC after~     the completion of patient accrual. The images will be analysed for lesions, enhancement~     patterns, diffusion weighted imaging data and correlated with any pathology or 1 year~     follow-up MRI exam. The study information will be entered into a secure database and~     analyzed.~   "
124480|NCT01938144|"~     This is a multicenter, prospective, randomized, double-blind, triple-dummy, parallel group,~     comparative, study designed to evaluate the efficacy of Ibuprofen (IBU) 200 mg/ Phenylephrine~     (PE) 10 mg and IBU 200 mg/ PE 10 mg/ Chlorpheniramine (CHLOR) 4 mg on the relief of symptoms~     of the common cold and flu. The reference product that the active treatments will be compared~     to is paracetamol (PARA) 500 mg.~   "
124494|NCT01937949|"~     This study will compare two groups of subjects with complex abdominal aortic aneurysms. It~     will compare their clinical outcomes and quality of life measures. The group being treated in~     this study will have their aneurysms repaired by an endovascular approach using Zenith®~     Fenestrated AAA Endovascular Graft. This group will be compared to a group of 461 patients~     (historical cohort) whose complex aneurysms were treated by open surgical repair.~   "
124576|NCT01936844|"~     Anakinra ADHF is a double-blind randomized clinical trial of anakinra, recombinant human~     interleukin-1 receptor blocker, or placebo in patients with acute decompensated heart failure~     with the aim to quench the acute inflammatory response, as measured by the~     area-under-the-curve for C reactive protein over 14 days.~   "
124481|NCT01938131|"~     The rehabilitation protocols in knee osteoarthritis are often difficult to be applied in~     elderly patients because they are long lasting and need the constant participation of~     patients. To rapidly improve the motor performances of patients it is possible to use the~     mechanical vibration applied to individual muscles using a protocol called repeated muscle~     vibration (rMV). The purpose of this single-blind randomized placebo-controlled study is to~     evaluate the effectiveness of the repeated muscle vibration (rMV) in terms of increasing the~     ability of the patients affected by knee osteoarthritis, compared to an ineffective~     treatment, considered as a placebo. Each subject, randomly assigned to either the group 1~     (study group) or placebo-treatment (group 2)is administered 3 daily applications of rMV of 10~     minutes each, for 3 consecutive days. Between two successive applications it's observed a~     break of at least 15 seconds. The probe of the specific instrument (Cro ® System) is placed~     near the supero-medial margin of the patella, on both quadriceps. Patients in group 2~     (control group) are subjected to a treatment with muscle released in which the probe of the~     same instrument is approached to the quadriceps, without making contact. The instrument in~     these conditions emits a buzz but not provokes muscle vibration. The primary outcome of the~     study is to determine the changing in patients' ability (as measured by WOMAC scale = Western~     Ontario and McMaster Universities Osteoarthritis Index) . The secondary outcomes of the study~     are the assessment of changing of patients' balance and risk of falling (as measured by the~     Tinetti scale) and assessment of changing of patients' quality of life (as measured by~     EQ-VAS= EuroQuality of Life-VAS scale).Outcome measures are administered at baseline (T0), at~     the end of the treatment protocol (T1), at 1 month (T2), 3 months (T3) after the end of~     treatment and 6 months (T4) after the end of the treatment.~   "
124482|NCT01938118|"~     The purpose of this study is to conduct a randomized controlled trial among 468 Non-Hispanic~     black mothers and their families to test the efficacy of MOTHERS AND OTHERS, a~     multi-component home visitation program, compared to an attention control (child safety) in~     promoting appropriate weight gain during infancy.~   "
124483|NCT01938105|"~     The purpose of this study is to determine the feasibility and efficacy of preoperative~     nimotuzumab injection combined with concurrent chemoradiotherapy for initially inoperable,~     locally advanced cervical cancer.~   "
124484|NCT01938092|"~     To determine the efficacy of intravaginal diazepam for the treatment of pelvic pain~     associated with pelvic floor hypertonic disorder.~   "
124485|NCT01938079|"~     In a healthy patient, the lungs provide oxygen to the blood and remove carbon dioxide.~     However, in patients with severe lung failure, blood may not adequately be delivered to the~     lungs, or the lungs may not adequately supply blood with oxygen. In this case, patients may~     require assistance from a machine to help provide this oxygen. Extracorporeal membrane~     oxygenation (ECMO) is a device that acts as an artificial lung, allowing the patient to~     recover from their illness. Patients receiving support from ECMO are often put in a medically~     induced coma while their lungs heal. Certain drugs may stick to the internal surfaces of the~     machine; therefore leading to decreased concentrations. Patients receiving ECMO often require~     high doses of both pain medications and sedatives in order to provide comfort. Low doses of a~     drug, ketamine, may help to provide additive effects to pain relief and allow lower doses of~     other pain medications. The hypothesis is that patients treated with continuous intravenous~     ketamine, will have lower requirements of other pain medications while receiving ECMO for~     acute respiratory failure while achieving the desired level of sedation.~   "
124486|NCT01938066|"~     The purpose of this study is to determine if Procellera speeds wound healing. The study will~     examine colonization (bacterial growth), pain and pain medication and reduced cost of care by~     using Procellera (an antimicrobial agent) under Negative Pressure Therapy placed on the wound~     after abdominal wall surgery. Procellera is a single layer dressing that helps to kill germs~     that cause infections. Negative Pressure Therapy is a vacuum device with a sponge that is~     placed in your wound to help heal the wound faster.~   "
124487|NCT01938053|"~     The primary goal of this project is to improve the process for contacting patients that test~     positive for a sexually transmitted infection (STI) in the emergency department by using text~     messaging. We believe patients that are contacted by both a phone call and a text message~     will be reached more often and they will be reached sooner than those that only receive a~     phone call or only a text message. In addition, patients will be given reminder cards at the~     time of testing to remind them that they will be contacted within 7 days if they test~     positive. Half of the reminder cards will have a number to call for test results. We believe~     patients that receive a card with a number are more likely to be contacted within 7 days.~   "
124488|NCT01938040|"~     This study is being done because the investigators wish to study ways to improve recovery~     after surgery. Injury, including surgical injury, causes inflammation. Inflammation is the~     body's attempt to protect itself and to start the healing process. Some surgical~     complications are related to the body's natural inflammatory response. Although mainly a~     healing response, inflammation can also have side effects which delay recovery. The~     investigators wish to determine the effect of a medication known as ibuprofen on recovery.~     You may know ibuprofen by the name Advil or Motrin. The medication will be given through the~     vein prior to the start of the surgery. Three blood samples will be taken, two while the~     patient is under anesthesia. The subject will be asked to complete several questionnaires.~   "
124489|NCT01938027|"~     The purpose of this study is evaluation of the safety and the efficacy of transanal total~     mesorectal excision.~   "
124490|NCT01938014|"~     Hypothesis: Children diagnosed with a lysosomal disease will exhibit developmental, adaptive,~     and behavioral strengths and difficulties depending upon 1) biomedical risk factors (i.e. the~     specific genetic disorder responsible for the illness); 2) available modifying interventions,~     whether medical or behavioral; and 3) social risks in the children's families, neighborhoods~     and communities. A valid and reliable telephone-based surveillance system can successfully~     collect the data required to elucidate these developmental, adaptive and behavioral strengths~     and difficulties.~   "
124491|NCT01938001|"~     This double-blind randomized, parallel group study will evaluate the efficacy and safety of~     lenalidomide (Revlimid, CC-5013) in combination with rituximab (MabThera/Rituxan) in patients~     with relapsed or refractory follicular lymphoma or marginal zone lymphoma. Patients will be~     randomized to receive either lenalidomide or placebo for twelve 28-day cycles in combination~     with rituximab. Anticipated time on study treatment is 1 year.~   "
124492|NCT01937988|"~     This study will be a non-blinded randomized controlled trial (RCT) of women presenting for~     abortion at <13 6/7 weeks. Women will be randomized either to receive support by a trained~     abortion doula (intervention) or to have standard procedure (control) during the abortion~     procedure. The investigators hypothesize that women who receive doula support during a first~     trimester abortion will report less pain during the abortion procedure compared to women who~     do not receive abortion doula support.~   "
124495|NCT01937936|"~     Family caregivers are vulnerable to health problems because of the stress and demands of~     their role as a caregiver. With the growing incidence of heart failure (HF) and the~     anticipated growth in the aging population, the number of HF caregivers is expected to rise.~     This study will pilot test a cognitive behavioral intervention designed to reduce stress~     among HF caregivers, which will ultimately contribute to promoting health and quality of life~     among HF caregivers and their loved ones with HF.~   "
124496|NCT01937923|"~     This observational study will establish a clinical baseline and measure changes over time in~     movement, thinking, behavior, brain imaging, blood and spinal fluid markers in subjects with~     early stage Huntington's disease. Participants enrolled in this study may be eligible to~     participate in a future planned study of stem cell therapy for Huntington's Disease (HD).~      In-person study visits occur at screening, baseline, and every 6 months thereafter for a~     minimum of 12 months, with interim phone call assessments.~   "
124497|NCT01937910|"~     The main goal of this research is to advance understanding of how stroke changes both the~     structure and function of the brain. The investigators will determine which is the key driver~     of recovery of arm function after stroke: changes in the structure of the brain or changes in~     how brain regions interact with one another.~   "
124498|NCT01937897|"~     In depression, EEG studies have shown frontal asymmetry with relatively lower activity in the~     left hemisphere. In this study a moderate pressure massage will be conducted by a trained~     professional on one of the following conditions: the right side of the body, the left side of~     the body, or both sides of the body (a traditional massage on the back of the body) while EEG~     measurements of brain activity are recorded and mood ratings are obtained.~   "
124499|NCT01937884|"~     Optimal delivery of nutritional support during critical illness is central to appropriate~     intensive care unit management, and yet fundamental gaps in knowledge exist regarding timing,~     route, dose, and type of nutritional support for critically ill infants and children.~     Understanding how to optimize nutritional support during pediatric critical illness is~     important because even brief periods of malnutrition in infancy result in permanent negative~     effects on long-term neurocognitive development. Optimized nutrition support is a way to~     improve morbidity for survivors of pediatric critical illness. Parenteral nutrition (PN)~     supplementation could improve long-term neurocognitive outcome for pediatric critical illness~     by preventing acute malnutrition, but has unknown effects on intestinal barrier function; a~     proposed mechanism for late sepsis and infectious complications during critical illness.~      While randomized controlled trials (RCT) support early PN in premature infants and late PN in~     critically ill adults, the optimal time to begin PN is unknown for critically ill infants and~     children. Acute malnutrition may develop within 48 hours of admission in critically ill~     infants and children, and repleted energy stores are predictive of survival. And yet, due to~     concerns for PN-associated infectious morbidity, current PICU standard of care is to~     supplement with PN only in children who fail to enterally feed, as late as 7 days into their~     admission. Delays in nutrition may have long-term effects on cognitive outcome in older~     infants and children. In premature infants, PN begun within hours of birth results in~     improved 18-month neurocognitive outcome without an increase in infectious complications. An~     RCT is needed to determine if early PN in critically ill infants and children prevents acute~     malnutrition and improves short and long-term outcomes of PICU hospitalization.~      The central hypothesis of this proposal is that optimized early protein and calorie delivery~     will improve nutritional outcomes and intestinal barrier function for critically ill infants~     and children. The overall purpose of this study is to evaluate the efficacy and safety of~     early PN as a supplement to enteral nutrition to improve nutritional delivery, nutritional~     outcomes, and intestinal barrier function for infants and children with acute respiratory~     failure who are mechanically ventilated in the pediatric intensive care unit.~   "
124500|NCT01937871|"~     The purpose of this study is to see whether tadalafil can reduce the signs and symptoms in~     men with Erectile Dysfunction (ED) and Benign Prostatic Hyperplasia-Lower Urinary Tract~     Symptoms (BPH-LUTS) and improve their quality of life.~   "
124501|NCT01937858|"~     The value of HbA1c as a tool to determine glycemic control in patients with diabetes and~     renal failure has not been well studied, the same accepted normal ranges for HbA1c are~     applied to all patients with diabetes regardless of their renal function. We would like to~     evaluate the use of HbA1c as a tool of assessing long term glycemic control in this subgroup~     of patients with diabetes and evaluate the effect of dialysis on HbA1c~   "
124502|NCT01937845|"~     Evaluating the health outcomes of patients that were enrolled in Joslin's Why WAIT Program.~     These outcomes include BMI, A1C, lipid profile.~   "
124503|NCT01937832|"~     The purpose of this study is to evaluate the safety and Efficacy of Faropenem in~     community-acquired pneumonia (CAP) subjects~   "
124504|NCT01937819|"~     High-quality bowel preparation is a prerequisite for colonoscopy. Few studies have evaluated~     visual aids as a means of improving the quality of bowel preparation. We assess the effect of~     patient-judging dose adjustment of bowel preparation solution for bowel preparation using~     SMARTPHONE application on the quality of bowel preparation.~   "
124505|NCT01937806|"~     To prove that a study drug is noninferior to a control drug with a proportion of subjects who~     showed HBV DNA undetected (less than 400 copies/mL (69 IU/mL)) at the 48th week after 48-week~     administration of Besifovir 150 mg, or Tenofovir 300 mg as a control drug to chronic~     hepatitis B patients~   "
124506|NCT01937793|"~     This study is designed to investigate the treatment efficacy of 8 weeks swallowing exercise~     programs for patients with NPC after radiation therapy. This study also compares two~     different swallowing exercise: effortful swallow and Mendelsohn's maneuver, to see which one~     can bring more benefits to patients after a certain period of exercise training. Three~     assessment tools are selected to evaluate the study result: Mann Assessment of Swallowing~     Ability (MASA), videofluoroscopic swallowing study (VFSS), and Chinese version Swallowing~     Quality-of-Life Questionnaire (CSWAL-QOL). The hypothesis of this study is that the effortful~     swallowing exercise would have better treatment efficacy.~   "
124507|NCT01937780|"~     This is a prospective study of patients receiving radiotherapy or chemoradiotherapy for anal~     cancer. Treatment effect in terms of survival and local recurrence will be analyzed. The~     utility of PET-CT and MRI for radiotherapy and for prediction of treatment effect will be~     investigated. Molecular and genetic markers in tumor and blood will be analyzed for~     prognostic and predictive effects. Patient-reported outcomes, such as faecal incontinence,~     sexual dysfunction and quality of life will be assessed. A structured intervention program~     for management of late effects will be evaluated. Symptom relief of palliative radiotherapy~     will be investigated. The main purpose of the study is to increase the knowledge of anal~     cancer treatment, improve treatment results, and improve anal cancer survivor care.~   "
124508|NCT01937767|"~     This phase II study in patients undergoing elective cardiac surgery will evaluate the~     efficacy, safety, and pharmacokinetics of remimazolam, compared with propofol and~     sevoflurane, during the induction and maintenance of general anesthesia.~   "
124509|NCT01937754|"~     Oral supplementation of Neo40(TM), a nitrate lozenge, will reduce blood pressure in healthy~     adults with clinical prehypertension.~   "
136111|NCT01785628|"~     The project will investigate the effect of pharmacological and electric modulation of~     N-methyl-D-aspartate (NMDA) pathway on the cognitive flexibility and volitional movement~     preparation in patients with Parkinson's disease (PD).~   "
124510|NCT01937728|"~     The purposes of this study are:~        1. To test if 36 weeks of standard dose of ribavirin with PEGASYS® is non-inferior to~          standard dose of 48 weeks of ribavirin with PEGASYS® in SVR for patients with RVR and~          HVL~        2. To test if the 72 weeks of treatment with PEGASYS® plus standard dose ribavirin is~          superior to 48 weeks of the same treatment for patients with HCV RNA seropositivity at~          week 12~   "
124511|NCT01937715|"~     This is a multicenter, open label Phase 1b/2 study in patients with metastatic colorectal~     carcinoma. The Phase 1b will identify the dose of the combination of PF-05212384 plus~     FOLFIRI. The randomized, two-arm Phase 2 portion will compare the efficacy and safety of~     PF-05212384 plus FOLFIRI to that of bevacizumab plus FOLFIRI.~      The study population will consist of patients with mCRC previously treated with an~     oxaliplatin-based regimen in the first line setting or who have progressed within 6 months of~     the end of an adjuvant oxaliplatin-based regimen.~   "
124512|NCT01937702|"~     A trial, investigating the influence of injection speed and volume on the perception of~     subcutaneous injection pain.~   "
124513|NCT01937689|"~     Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This~     study is designed to evaluate the safety and tolerability of Pyrotinib in patients with HER2~     positive advanced breast cancer:~        -  To evaluate the safety and tolerability of pyrotinib, and the maximum tolerated dose~          (MTD)~        -  To determine the dose-limiting toxicity (DLT)~        -  To determine the pharmacokinetic profile of Pyrotinib and its metabolites~        -  To assess preliminary antitumor activity~        -  To determine preliminary regimen dose for phase II study~        -  To explore the relationship between biomarkers and the toxicity/efficacy of Pyrotinib.~   "
124514|NCT01937676|"~     The purpose of this study is evaluate if K3, a novel biomarker, sampled at arrival to the~     emergency department can be used to predict the development of organ failure measured as SOFA~     score. K3 consists of lactate dehydrogenase, albumin and magnesium combined.~   "
124515|NCT01937663|"~     The purpose of this study is to evaluate the efficacy and safety of tapered KWA-0711 dose in~     chronic constipation patients.~   "
124516|NCT01937650|"~     The objective of the study was to determine whether there was a difference in the~     effectiveness of Radiotherapy alone compared with Radiotherapy plus Metronidazole in the~     treatment of women with advanced cancer of the cervix in Mulago hospital. It was a randomized~     controlled trial composed of 38 women altogether, with one group composed of randomly~     selected women with advanced cancer of the cervix treated with radiotherapy alone and the~     other group composed of similar women but treated with radiotherapy and metronidazole.~   "
124517|NCT01937637|"~     Many individuals with lung cancer experience debilitating breathlessness at some point during~     the course of their illness. Unfortunately, few interventions exist to treat this distressing~     symptom of cancer.~      In this study, the investigators plan on recruiting individuals with lung cancer to~     participate in a behavioral intervention to help relieve breathlessness. The principal~     investigator of the study, Dr. Joseph Greer, is a licensed clinical psychologist who has~     trained nurse practitioners in how to deliver the behavioral intervention. The nurse~     practitioners will meet with patients diagnosed with lung cancer during their outpatient~     oncology appointments, such as chemotherapy infusions, to review the behavioral skills that~     may help with breathlessness. Specifically, the intervention includes education about the~     relationship between breathlessness and the stress response as well as teaches patients~     skills for breathing control and relaxation of the body.~      For this single-group pilot study, the investigators will ask participants to provide~     feedback about whether they found the intervention acceptable and effective. Participants~     will also complete questionnaires about their physical and psychological symptoms before and~     after the intervention in order to measure its effectiveness for treating breathlessness and~     any distress related to breathlessness. The data from this study will help inform~     improvements to the intervention in order to make it feasible and effective for treating~     breathlessness in patients with lung cancer.~   "
124518|NCT01937624|"~     The purpose of the study is to evaluate the sensitivity and specificity of using a diagnostic~     musculoskeletal ultrasound in pediatric distal radius fractures in an outpatient setting.~     Ultrasound reliability and accuracy will be tested. The result of the diagnostic ultrasound~     will be compared to x-ray diagnosis under routine conditions in the investigator's injury and~     fracture treatment evening clinic. Data will be collected and recorded during the duration of~     the 12 week study. Through the literature review and experience with ultrasound, the~     investigators anticipate that diagnostic ultrasound will provide very high sensitivity and~     specificity in diagnosing distal radius fractures in children.~   "
124519|NCT01937611|"~     Many studies have been conducted for the feasibility of using dexmedetomidine as~     premedication. However, bradycardia and hypotension frequently occurred following the~     premedication with dexmedetomidine, either via intramuscular or intravenous route. This is~     particularly true when using a high dose of dexmedetomidine: a intramuscular dose over 2~     μg•kg-1 or a intravenous dose over 1 μg•kg-1 can elicit marked decreases in heart rate and~     mean arterial blood pressure. Subsequent studies using high-dose dexmedetomidine further~     revealed the potential impact of its detrimental haemodynamic profile on clinical outcomes.~     Most studies using high-dose dexmedetomidine were predominantly adopted with the dose-finding~     study performed by Aho and colleague, whom reported that 2.5 μg•kg-1 dose of intramuscular~     dexmedetomidine was comparably sedative and anxiolytic to 0.08 mg•kg-1 midazolam. However,~     few investigations have addressed the clinical effects of low-dose dexmedetomidine as~     premedication. Considering modern anaesthesia has advanced a long way towards eliminating the~     routine need for a deep preoperative sedation. It has, therefore, become desirable to asses~     dexmedetomidine as an effective premedication using a moderate sedative dose to minimize its~     undesired hemodynamic effects. We set a prospective study to compare the sedative,~     haemodynamic, adjuvant anaesthetic effects and patient's satisfaction of low-dose~     dexmedetomidine (1μg•kg-1) with midazolam (0.03 mg•kg-1), the most commonly used~     premedication, used as an intramuscular injective administration in patients undergoing~     suspension laryngoscopic surgery under general anaesthesia.~   "
124520|NCT01937598|"~     Objectives: To quantify differences in control of glycemia (primary objective) and the~     secretion of endogenous incretin hormones (secondary objective) comparing sitagliptin or~     placebo added to pre-existing therapy with liraglutide and metformin~   "
124522|NCT01937572|"~     The purpose of the current study is to validate the technology of MRI-based alignment for~     total knee replacements and to collect data on potential advantages of the computer aided~     system.~        1. It is hypothesized that there will be no significant differences in position, loosening,~          or function of the Visionaire total knee as compared to the conventional total knee.~        2. It is hypothesized that the Visionaire total knee will be significantly better with~          regard to operative time, tourniquet time, blood loss, and procedural set-up, turnover~          time, and overall costs.~   "
124523|NCT01937559|"~     The objective of this study is to evaluate the efficacy of topical tranexamic acid (TXA) in~     decreasing blood loss following both shoulder arthroplasty and primary total hip~     arthroplasty. TXA functions to decrease blood loss by affecting the blood clotting system~     within the body. The investigators hypothesize that topical application of TXA prior to~     closure reduces postoperative bleeding as measured by absolute changes in postoperative~     hemoglobin levels and surgical drain output. In addition, use of topically applied~     tranexaminic acid may reduce the need for transfusions, the rates of hematomas, infections,~     and length of hospital stay.~   "
124524|NCT01937546|"~     It is unknown if primary delivery of the anterior or the posterior shoulder causes less~     perineal tear. The objective of this trial is to evaluate the incidence and degree of~     perineal trauma after primary delivery of the anterior shoulder compared to primary delivery~     of the posterior shoulder during vaginal birth in primiparous women in a randomized~     controlled trial. The hypothesis is that primary delivery of the posterior shoulder reduces~     the rate and degree of perineal trauma.~   "
124525|NCT01937533|"~     This study aims to develop the technique of Diffusion-Weighted Magnetic Resonance~     Imaging(DW-MRI)for the assessment of stage 1 cervical cancers. An endovaginal receiver coil~     has been designed and developed at the Institute of Cancer Research and Royal Marsden NHS~     Foundation Trust for use at high field strengths(3T). This will be used to evaluate if DW-MRI~     at 3T can be used to differentiate different histological characteristics within whole~     tumours and so determine if the technique could be of prognostic value.~      The study hypothesis is that this technique will be able to differentiate tumours with~     histological features known to be associated with poor prognosis (tumour type, grade and~     lymphovascular space invasion).~   "
124526|NCT01937520|"~     This study is being done because the investigators wish to study ways to improve recovery~     after surgery. Injury, including surgical injury, causes inflammation. Inflammation is the~     body's attempt to protect itself and to start the healing process. Some surgical~     complications are related to the body's natural inflammatory response. Although mainly a~     healing response, inflammation can also have side effects which delay recovery. The~     investigators wish to determine the effect of acupuncture on post-operative surgical pain. An~     increase in pain after surgery can cause distress for patients. Acupuncture is an alternative~     medicine methodology originating in China that treats patients by manipulating thin, solid~     needles that have been inserted into acupuncture points in the skin. Acupuncture has been~     used for the reduction of pain. The investigators would like to see if acupuncture during~     surgery can provide a lower level of pain, reduced pain medication requirement, and a lower~     incidence of nausea and vomiting.~   "
124527|NCT01937507|"~     Deliver oxliplatin and 5-FU via HAI to breast cancer patients with liver-only or~     liver-predominant metastases who have failed at least one line of systemic chemotherapy in~     metastatic setting.~   "
124528|NCT01937494|"~     Bronchial hyperresponsiveness consists in excessive response to bronchial stimuli.Bronchial~     challenge test is used to confirm/exclude asthma (metacholine or histamine).Protection are~     used to avoid passive exposure of the technicians performing the test, despite the absence of~     evidence that they could develop a bronchoconstriction even if they suffer from BHR.The~     purpose of the study is to determine if patients with a high level of bronchial~     hyperreactivity and exposed passively to histamine during a bronchial challenge, are~     developing a bronchoconstriction, when placed in the same conditions that the technicians~     performing these tests.~   "
124529|NCT01937481|"~     The Colorado Longitudinal Eating And Physical activity (LEAP) Study utilizes a social~     ecological approach to explore individual, family and environmental factors and their~     relationship to child weight status over a 3 year timeframe. Our primary research questions~     are as follows:~        1. Are behavior changes (increased willingness to try new foods and gross motor skills)~          from a preschool nutrition and activity program, The Food Friends®, sustained through~          early elementary school?~        2. Do The Food Friends® programs have an impact on reducing the percentage of children~          considered overweight and/or obese over a 3 year timeframe?~        3. Do food preference and gross motor performance directly affect child weight status or~          are they mediators to dietary intake and physical activity?~   "
124530|NCT01937468|"~     This research study is a Phase I clinical trial, which tests the safety of an investigational~     combination of IL-2 plus donor anti-inflammatory Treg cells and also tries to define the~     appropriate dose of the investigational combination of IL-2 plus donor anti-inflammatory Treg~     cells to use for further studies. IL-2 is involved with cell signaling and regulation of~     white blood cells (WBCs). WBCs are part of the immune system. Treg cells are also part of the~     immune system; they are involved with anti-inflammatory responses. Investigational means~     that the combination of IL-2 and anti-inflammatory Treg cell infusion is being studied. It~     also means that the FDA (U.S. Food and Drug Administration) has not approved the combination~     of IL-2 and anti-inflammatory Treg cell infusion for use in people with cGVHD.~      Chronic GVHD is a medical condition that may occur after you have received your bone marrow,~     stem cell or cord blood transplant from a donor. The donor's immune system may recognize your~     body (the host) as foreign and attempt to 'reject' it. This process is known as~     graft-versus-host disease.~      Traditional standard therapy to treat cGVHD is prednisone (steroids). Participants on this~     trial have not responded to steroid therapy. The investigators are looking to assess the~     safety and optimal dose for the combination of IL-2 plus donor anti-inflammatory Treg cells,~     that may help control cGVHD by stopping the donor's immune system from 'rejecting' your body.~   "
124531|NCT01937455|"~     The purpose of this study is to evaluate the safety, tolerability and immunogenicity of~     rAAV1-PG9DP when administered intramuscularly at different dose levels in healthy male~     adults.~   "
124532|NCT01937442|"~     Objective of this study is to characterize the steady-state pharmacokinetics (PK) of~     thalidomide when given orally as monotherapy to subjects with multiple myeloma.~   "
124533|NCT01937429|"~     The colonoscopy is the reference examination for the diagnosis of neoplastic lesions in the~     colon and rectum. Mass screening assessment studies have shown that colonoscopic detection~     and removal of adenomas in patients selected through fecal occult blood test reduces~     colorectal cancer incidence and mortality. However, the literature has reported interval~     cancer cases or adenomas, probably missed by the colonoscopy. In theory, using coloured~     warm water could improve colon preparation by mobilizing the residual faeces, decreasing the~     colic spasm and increasing the visualization of the pit pattern. Preliminary American~     studies, led by Leung et al, have shown a very clear increase in the adenoma detection rate.~      The investigators' study involves 1 000 patients, treated in the Rhône-Alpes / Auvergne~     region. The patients present an indication for colonoscopy following a positive fecal occult~     blood test or symptoms or personal and family histories of pre-cancerous colonic lesions.~     They will be randomized into two study groups:one of both groups of study: Group 1: patients~     undergoing a colonoscopy wtih instillation of tepid water tinged with blue (Indigo Carmin®)~     Group 2: patients undergoing a standard colonoscopy with insufflation of air. The main~     objective is to show that the colonoscopy with blue water (Indigo Carmin®) enable detection~     of more lesions than standard colonoscopy with insufflation of air. The two techniques will~     be also compared in terms of tolerance, of duration of colonoscopy and type of detected~     lesions.~      In case of improved detection of colorectal lesions, the blue water instillation technique of~     could dramatically change gastroenterologists' practice by becoming the reference method. The~     expected clinical benefits are potential revealing of more neoplastic lesions and improvement~     in abdominal discomfort after colonoscopy.~   "
124534|NCT01937416|"~     This study is to evaluate the safety and efficacy of autologous bone marrow mononuclear cells~     transplantation in diabetic patients with lower limb ischemia.~   "
124535|NCT01937403|"~     The primary purpose of this study is to determine the interrater reliability and validity of~     the Sportcord Test as a measure of physical performance following anterior cruciate ligament~     (ACL) reconstruction. A secondary purpose is to systematically track subjective and objective~     outcomes on patients following ACL reconstruction to help identify differences between those~     who have subsequent knee problems and those who do not. The study hypotheses are the~     following:~      1) The Sportcord Test will provide a valid and reliable measure of functional performance~     following ACL reconstruction. 2) Patients who have subsequent knee problems in the 12 month~     study period will exhibit different scores on clinical special tests compared to those who do~     not.~   "
124536|NCT01937390|"~     The objective of the study is to observe the effect of adherence to once-daily administered~     long-acting bronchodilators (long-acting ß2-agonists [LABAs] / long-acting muscarinic~     antagonists [LAMAs]) on patients health related quality of life (HR-QoL) and to assess the~     relation between symptoms improvement and adherence to Chronic Obstructive Pulmonary Disease~     (COPD) maintenance therapy~   "
124537|NCT01937377|"~     In this part of the Registry Program patients with non-valvular atrial fibrillation (AF) at~     risk for stroke are enrolled to characterize the target population and to collect real world~     data on important outcome events. For administrative purposes the study is divided into three~     protocol numbers: 1160.129 for all non-EU (European Union) and non-EEA (European Economic~     Area) countries, 1160.136 for EU and EEA countries and 1160.171 for India and Switzerland.~     The total number of patients enrolled in three protocols is estimated to be 48,000 patients,~     and all these patients will be included in the data analysis for study 1160.129.~   "
124538|NCT01937364|"~     The purpose of this study is determine if the medication baclofen can prevent the symptoms of~     Alcohol Withdrawal Syndrome (AWS) in hospitalized patients who may be at risk for AWS. This~     medication is most often used for patients who have spasticity of their muscles due to a~     neuromuscular disease. In several European studies, and in an earlier study at Essentia~     Health (NCT00597701), baclofen has been found to have a significant effect on the severity of~     symptoms of AWS.~   "
124539|NCT01937351|"~     A non-randomized, prospective, global clinical trial of the Avinger Pantheris System, an~     atherectomy device that provides directional visualization and imaging as an adjunct to~     fluoroscopy to aid removal of plaque in diseased lower extremity arteries.~   "
124540|NCT01937338|"~     Study to investigate the effect of a single dose of AZD7624 on inflammation caused by an~     endotoxin challenge.~   "
124541|NCT01937325|"~     Ivacaftor will restore CFTR function in treated CF patients with the G551D mutation.~     Improvement in ventilation, salt balance and well-being will contribute to better exercise~     capacity at all levels of lung function. While potential improvements may be variable across~     the spectrum of lung function, even small gains at low levels of FEV1 may have significant~     benefit for some subjects.~   "
124542|NCT01937312|"~     The purpose of this study is to demonstrate the additive effect of brinzolamide~     1%/brimonidine 0.2% (SIMBRINZA® suspension) in subjects with either open angle glaucoma or~     ocular hypertension who are currently on a prostaglandin analogue (PGA) monotherapy.~   "
124543|NCT01937299|"~     The purpose of this study is to demonstrate the additive effect of brinzolamide~     1%/brimonidine 0.2% (SIMBRINZA® suspension) in subjects with either open angle glaucoma or~     ocular hypertension who are currently on a prostaglandin analogue (PGA) monotherapy (TRAVATAN~     Z®).~   "
124544|NCT01937286|"~     Within community with high incidence of HCC, stretching the limits could be justified based~     on tumor characters and its biological behavior~   "
124545|NCT01937273|"~     Cancer patients are one of the patient groups at highest risk for the development of~     malnutrition. Anti-cancer treatments, such as chemotherapy and radiotherapy, can further~     heighten the risk due to the nutrition-related toxicities experienced during this time.~      This study aims to baseline the nutritional status of chemo-radiotherapy patients undergoing~     treatment at the Alan Walker Cancer Care Centre (Darwin), identify contributors to~     nutritional deterioration and determine if there is a difference between Indigenous and~     non-Indigenous patients.~   "
124546|NCT01937260|"~     This is a phase 1, multi-center, open-label, drug-drug interaction (DDI) and PK study in~     subjects with moderate to severe plaque psoriasis. It is designed to evaluate the effect of~     brodalumab on midazolam PK in addition to assessing single dose PK of brodalumab in subjects~     with moderate to severe plaque psoriasis.~   "
124547|NCT01937247|"~     The main purpose of the study is to examine whether operating room (OR) efficiency will be~     improved by significantly decreasing non operative time. This study also aims: 1) to evaluate~     whether a decrease in non-operative time will result in increased surgeon and staff~     satisfaction, 2) to determine whether there is an increase in the complication rate during~     the redesigned process perioperatively and until discharge from the post anesthesia care~     unit, and 3) to rate patient satisfaction.~   "
125463|NCT01925248|"~     The purpose of this study is to investigate whether intake of protein supplement just before~     meals lowers the blood sugar levels after the meals. It is believe that pre-meal~     administration of a high-protein supplement can effectively improve glycemic control in type~     2 diabetes (DM).~   "
124548|NCT01937234|"~     Reducing the length of labor is a highly desirable goal of intrapartum care, both from a~     perspective of maternal and fetal well-being , and for the providers of the birth services.~     Avoiding a long , protracted labor entails shorter exposure to pain anxiety and stress and~     would translate into a major improvement in maternal satisfaction with the child birth~     experience.~      The purpose of this study is to determine the effectiveness of metoclopramide for reducing~     the duration of spontaneous labor among nulliparous women managed according to a standard~     intrapartum protocol.~   "
124549|NCT01937221|"~     The goal of this study is to create new retinal imaging processing software useful for the~     development of novel retinal biomarkers of cognitive impairment associated with Alzheimer's~     disease (AD).~   "
124550|NCT01937208|"~     Radiation therapy plus concurrent chemotherapy is now the standard therapy for patients with~     localized carcinoma of the esophagus selected for nonsurgical treatment. The standard~     radiation dose is 50-50.4Gy/1.8-2.0Gy/F.All of this were based on 2D radiation technology.~     Entering new century, 3D-CRT or IMRT has used on esophageal cancer. In China,the recommend~     radiation dose of concurrent chemoradiation was 60Gy. The study is a clinical phase III,~     randomized trial to compare the different radiation dose(60Gy vs 50Gy) of concurrent~     chemoradiation using 3D-CRT or IMRT in patients with unresectable esophageal carcinoma.~   "
124551|NCT01937195|"~     The study will test a hypothesis that the AccuCath™ System will have a higher rate of~     successful first attempt peripheral intravenous (PIV) placement, higher completion of~     therapy, fewer complications, longer dwell times, and higher user satisfaction compared to~     Conventional IV Catheters.~   "
124552|NCT01937182|"~     We wish to conduct a prospective, randomized, double blind, placebo controlled multi center~     study of the combined neuroprotective and antithrombotic effects of SSRI treatment after~     stroke.~      Hypotheses:~      SSRI treatment commenced in the acute phase of stroke (day 0-7) protects against new~     thromboembolic events and leads to better rehabilitation. 600 stroke patients will be~     randomized in a 1:1 ratio.~      The treatment and follow up period is 6 months. During these 6 months there will be 2~     clinical follow up visits, one telephone control and one visit to evaluate compliance~     regarding medication.~   "
124553|NCT01937169|"~     Neurons in the brain require blood and oxygen for proper function. The term neurovascular~     coupling has been postulated in the 19th century by Roy & Sherrington referring to increased~     blood flow to active neurons. The rationale of this research relies on the neurovascular~     coupling, suggesting that increased blood flow to active regions on the brain should supply~     not only more blood, but also more of a pharmacological agent present in the blood system at~     the time. Thus, active regions should be affected by the agent (=drug) to a greater extent.~      In the present study we focus on the dopaminergic system, critical in many functions such as~     cognition, response to stimuli and movement. One of the well-known dopaminergic pathways in~     the brain is the nigrostriatal pathway, mediating motor function. In this research, we intend~     to examine the effects of coupling functional activation in this pathway with a dopaminergic~     agent, Carbidopa/Levodopa, on symptoms of Restless Leg Syndrome (RLS). RLS is characterized~     by an irresistible urge to move the limbs (i.e. Akathisia), and results most prominently by a~     significant decrease in the quality of sleep. Our research focuses on this symptom of RLS to~     examine the effect of coupling brain activation and drug treatment.~      The first line of treatment in RLS is dopaminergic drugs. These drugs increase dopamine~     levels in motor pathways, and our research will aim to couple activation in the nigrostriatal~     motor pathway with dopaminergic treatment in RLS. Functional activation will be achieved with~     a simple motor task, known to elicit activation in the nigrostriatal pathway. We hypothesize~     that the drug will act upon the pre-activated motor system, and that this coupling between~     brain activation and drug treatment will ameliorate sleep-related symptoms of RLS, compared~     with treating these symptoms solely with a dopaminergic drug and compared with using a~     non-motor task.~   "
124554|NCT01937156|"~     The purpose of this study is to assess the efficacy and safety of SP-01 in~     chemotherapy-induced nausea and vomiting (CINV) associated with the administration of~     moderately or highly emetogenic (ME or HE) multi-day chemotherapy，which will provide~     scientific and reliable clinical data in the drug registration in China.~   "
124555|NCT01937143|"~     Immunization injections are the most common recurring painful medical procedure undertaken in~     childhood. Numerous evidence-based and feasible interventions are available to mitigate~     immunization pain, however, there is low uptake of these interventions in clinical practice,~     revealing a knowledge-to-care gap between what is known about pain and pain management. This~     is a 4-year single-centre, randomized, parallel 3-group add-on trial that will enrol 3420~     mothers hospitalized following the birth of an infant at Mount Sinai Hospital (MSH) in~     Toronto. The trial will evaluate and compare the impact of two levels of intensity of~     maternal education about pain management during infant immunizations ('low': pamphlet vs.~     'high': pamphlet + video) compared to placebo control after the birth of an infant on~     maternal behaviour during future infant immunizations at up to 6 months of age (use of~     analgesic interventions), maternal knowledge and attitudes about pain and pain management up~     to 6 months after birth.~   "
124556|NCT01937130|"~     The study will evaluate the pharmacokinetics, pharmacodynamics, safety and preliminary~     efficacy of IDN-6556 in subjects with cirrhosis of the liver who are hospitalized for more~     than 24 hours due to acute deterioration of liver function.~   "
124557|NCT01937117|"~     This research is being done to determine if early changes on a type of imaging procedure~     called PET (Positron Emission Tomography) can predict which patients are most likely to~     respond to the combination of trastuzumab and pertuzumab when given prior to surgery.~   "
124558|NCT01937104|"~     Increase of intracerebral pressure (ICP) during laparoscopic surgery has known to be~     associated with positional changes. Optic nerve sheath diameter (ONSD) has correlation with~     ICP and ultrasonographic measurement of optic nerve sheath diameter (ONSD) is known to be a~     noninvasive and rapidly applicable technique for evaluating ICP. The aim of this study is to~     investigate the change of ONSD according to the positional change during laparoscopic~     surgery.~   "
124559|NCT01937091|"~     Purpose: To comprehensively explore the barriers and motivators for participation in HIV~     clinical trials in a purposive sample of HIV positive patients receiving care at the UNC ID~     (Infectious Diseases) clinic Participants: HIV positive patients seen at the UNC ID Clinic.~     Participants will be purposively sampled based on gender, race and previous participation in~     HIV clinical trials. Blacks and patients who have never participated in clinical trials will~     be oversampled.~      Procedures (methods): Cross-sectional study using in-depth semi-structured qualitative~     interviews to determine the barriers and motivators for participation in HIV clinical trials.~     Patient interviews will be audiotaped, transcribed verbatim and analyzed using Atlas.ti~     software to understand the barriers and motivators for participation in HIV clinical trials.~   "
126969|NCT01905527|"~     This is a Phase IV study to compare the current level of MS LifeLines ® (MSLL) services~     (face-to-face nursing visits and phone contacts) with customized MSLL services, to determine~     the optimal services to enhance medication adherence and treatment persistence with Rebif ®~     subcutaneous three times a week.~   "
124560|NCT01937078|"~     Levodopa-induced dyskinesia is a common problem in Parkinson's disease (PD). In particular,~     targeting non-dopaminergic systems may be an option for reducing dyskinesia without worsening~     motor symptoms. One such target may be histamine. The central histaminergic system is~     involved in diverse biological functions including thermoregulation, eating, and sleep; a~     role in motor activity is suggested by strong histaminergic innervation of the basal ganglia.~     Histamine H2 receptors are highly expressed in the striatum, particularly on the GABAergic~     striatal-pallidal and striatal-nigral pathways Histamine H2 stimulation modulates~     acetylcholine release. Previous studies have demonstrated that blocking acetylcholine with~     anticholinergic agents can induce chorea. The investigators propose that histamine H2~     receptor stimulation decreases acetylcholine in the striatum and increases activity of the~     direct striatal output pathway, a key component of the neural mechanisms underlying~     dyskinesia.~      The investigators hypothesise that H2 antagonists would reduce activity of the direct~     striatopallidal pathway and so potentially reduce levodopa-induced chorea~      Famotidine has also been assessed in schizophrenia in a small cases series to treat~     schizophrenia, with tolerability. Clinical experience thus suggests the suitability of using~     this agent as a histamine H2 antagonist in clinical studies for PD.~   "
124561|NCT01937065|"~     Study of heterogeneity in associations between social deprivation and the initial~     presentation of 12 cardiovascular diseases.~   "
124562|NCT01937052|"~     The purpose of this project is to establish a repository of information and samples from~     breast cancer patients or those at high risk of developing breast cancer, who are initiating~     hormone therapy as part of standard clinical care or prevention. This repository will include~     patient reported outcomes and other questionnaires, information on medication use, data about~     adherence to the hormone therapy and tumor characteristics, including prospectively collected~     samples.~   "
124563|NCT01937039|"~     The Breast Cancer Program Longitudinal Repository (BCPLR) is being established to fulfill the~     research mission of the Breast Cancer Program at Johns Hopkins and to serve investigators~     affiliated with it - to develop a repository of specimens with corresponding characteristics~     from patients seen in the breast care and cancer clinics.~   "
124564|NCT01937026|"~     The purposes of this study are to assess how the body handles baricitinib when it is given~     with another drug called probenecid. The study doctor will measure the amount of baricitinib~     that is absorbed into the blood stream and the time that it takes to remove baricitinib from~     the body. The safety and tolerability of these drugs will be studied. The study will last~     about 18 days from the first dose to the end of the study (not including screening).~   "
124565|NCT01937013|"~     This study will evaluate the effects on emotions and neural activity of a one time dose of~     intranasal oxytocin vs. placebo in patients with FTD and healthy controls.~   "
124566|NCT01936974|"~     To evaluate progression-free survival with two chemotherapy regimens on~     platinum-resistant/refractory ovarian and peritoneal carcinoma~   "
124567|NCT01936961|"~     The purpose of this study is to use Immunochemotherapy +/- Hypofractionated Radiation for~     complete response in solid tumors~   "
124568|NCT01936948|"~     The effectiveness of colonoscopy in reducing colorectal cancer mortality relies on the~     detection and removal of neoplastic polyps. Because the risk of prevalent cancer and of~     transition to cancer increases with polyp size, effective and safe resection of large polyps~     is particularly important. Large polyps ≥20mm are removed by so-called endoscopic mucosal~     resection (EMR) using electrocautery snares. Resection of these large polyps is associated~     with a risk of severe complications that may require hospitalization and additional~     interventions. The most common risk is delayed bleeding which is observed in approximately~     2-9% of patients. A recent retrospective study suggests that closure of the large mucosal~     defect after resection may decrease the risk of delayed bleeding. However, significant~     uncertainty remains about the polypectomy techniques to optimizing resection and minimizing~     risk. Important aspects that may affect risk include clipping of the mucosal defect and~     electrocautery setting.~   "
124569|NCT01936935|"~     The aim of this trial is to evaluate the effects of dairy product consumption on insulin~     sensitivity and pancreatic β-cell function in men and women at risk for the development of~     type 2 diabetes mellitus (T2DM) who habitually consume beverages high in sugar (non-diet~     sodas and fruit juice cocktails).~   "
124570|NCT01936922|"~     A virtual reality device has already been successfully used for improving gait in adults who~     have neurological conditions. We will evaluate if it is feasible to study the brief use of~     this device in older adults who have had falls.~   "
124571|NCT01936909|"~     The RED-HART is a randomized double-blinded placebo-controlled study of Anakinra (IL-1~     blocker) in patients with recently decompensated heart failure to determine the safety and~     efficacy in terms of aerobic exercise capacity and ventilatory efficiency measured with a~     cardiopulmonary exercise test.~   "
124572|NCT01936896|"~     Acute myocardial infarction is characterized by an intense inflammatory response.~      The degree of the response influences clinical outcome, with 'more' inflammation promoting~     heart failure. In this study we plan to determine whether treatment with plasma derived~     alpha-1 antitrypsin will quench the inflammatory response in patients with acute ST-segment~     elevation myocardial infarction (STEMI).~   "
124573|NCT01936883|"~     Optimal non surgical treatment of prostate cancer requires dose escalation which is~     frequently provided by adding a brachytherapy boost to a short course of external beam~     radiotherapy. The hypothesis in this randomized study is that a High Dose Rate (HDR)~     brachytherapy boost leads to equivalent or better Prostate Specific Antigen (PSA)~     recurrence-free survival when compared to a Low Dose Rate (LDR) brachytherapy boost and that~     it is associated with a more favorable toxicity profile and improved quality of life.~   "
124574|NCT01936870|"~     The purpose of this study is to collect effectiveness and safety information of fesoterodine~     related to their appropriate use in daily practice.~   "
124575|NCT01936857|"~     The purpose of this study is to compare two models of substance abuse treatment in Vietnam,~     and how they each affect HIV care. In Vietnam, the current model for treating people with HIV~     who are also dependent on opioids is to refer them to methadone maintenance treatment~     centers. The new model the protocol will study is treatment of HIV and opioid dependence with~     buprenorphine/naloxone and counseling in the HIV clinic.~   "
124577|NCT01936831|"~     Isoniazid (INH) is a drug commonly used to treat TB worldwide. Sometimes, the bacteria that~     cause TB can become resistant to INH. Resistance means that bacteria have adapted to a drug~     and are able to live in the presence of the drug. When TB becomes resistant to INH, INH does~     not work as well at fighting the bacteria. This study will treat people with INH-resistant TB~     with different doses of INH to see if INH can still fight the bacteria if we just increase~     the dose. We will compare how well the drug works at higher doses for participants who have~     resistant TB to how well the drug works at regular doses for participants who have TB that is~     not resistant. The study will also compare the safety and tolerability of the different doses~     of INH. Tolerability is how well people can put up with the side effects of a drug. Using~     increased doses of INH to treat TB that is resistant to INH is experimental and has not been~     approved by regulatory authorities. While there is some evidence that this approach will~     work, this has not yet been proven.~      This study will be done in two stages. Stage 1 is a pilot study to determine the feasibility~     of enrolling enough participants into Stage 2, the larger stage of this study. If Stage 1 is~     successful, then Stage 2 will begin.~   "
124578|NCT01936818|"~     A Multi-Center Study Evaluating the Nasal Allergic Symptomatology Induced by a Nasal Allergen~     Challenge (NAC) in a Dust Mite Population~   "
124579|NCT01936805|"~     The aim of the present study was to evaluate the effect of pre-procedural single high loading~     dose (40 mg) of rosuvastatin on the primary end-points of all cause mortality and composite~     of death or myocardial infarction from cardiovascular (CV) causes, target vessel~     revascularization (TVR), or stroke.~   "
124580|NCT01936792|"~     The purpose is to use Diffusion Kurtosis Imaging (DKI), Diffusion Tensor Imaging (DTI) and~     resting state functional MRI to examine tissue damage in the brains of people who have had a~     concussion, both acute and 3 months after the accident. A secondary purpose is to examine~     whether the results of the scans are associated with physical, cognitive and emotional~     problems after concussion.~      It is hypothesized that there will be a change in the diffusion signal measured with DKI in~     the thalamus (THA) and with DTI in the corpus callosum (CC), in the acute stage and at~     follow-up of the mTBI subjects compared with the healthy controls. Secondary it is expected~     that there will be changes in the diffusion signal measured with DKI and DTI in other WM and~     GM area in both the acute stage and at follow up with mTBI subjects compared with healthy~     controls. Also rs-fMRI markers are secondary expected to differ in the two groups. Moreover~     secondarily the MRI markers are tested for correlation with the severity of PCS acutely and~     at follow up after mTBI.~   "
124581|NCT01936779|"~     High levels of fatty substances in the blood increase the risk of developing heart disease.~     Investigators know a lot about one of these fatty substances, cholesterol. However, there is~     another fatty substance in the blood called triglyceride. Investigators do not understand~     much about what regulates the rate at which the liver produces triglyceride and liberates it~     into the bloodstream after eating a meal(s). It is known that taking fish oil lowers the~     amount of blood triglyceride however, it remains unclear how this happens. Investigators will~     study if changes in liver fat metabolism, after taking fatty acids found in fish oil (n-3~     fatty acids)can explain the lowering of blood triglyceride. Investigators also want to know~     if taking fish oil alters the amount of fat that accumulates within the liver.~   "
124582|NCT01936766|"~     Optimal fluid therapy in severe falciparum malaria has not been well defined, especially in~     resource poor settings where access to mechanical ventilation is limited. Recent studies~     suggest that liberal fluid resuscitation is harmful for severe malaria patients despite they~     often being hypovolemic on admission. In order to elucidate the minimum fluid therapy~     required to prevent complications in severe malaria, we will conduct a prospective~     observational study in adults with severe malaria, and also in adults with severe sepsis as a~     comparison group. The objective of this study is to describe the association between~     hemodynamic variations in conventional fluid management and the probability of developing~     acute kidney injury (AKI) or pulmonary edema in adults with severe malaria and severe sepsis.~     Hemodynamic measurements will be obtained by using transpulmonary thermodilution and arterial~     pulse contour analysis.~   "
124583|NCT01936753|"~     Nigeria has significant challenges in the delivery and coverage of PMTCT (Prevention of~     mother-to-child transmission of HIV) services. Only 30% of pregnant women living with HIV are~     provided anti-retroviral drugs for PMTCT. Less than 10% of HIV-exposed infants receive HIV~     testing for early diagnosis by age 2 months. Furthermore, an unacceptably high number of~     women with HIV who are enrolled in PMTCT programs do not complete them. In other words,~     uptake and retention in PMTCT programs in Nigeria is not adequate. Ultimately,~     mother-to-child transmission of HIV is high, resulting in a high number of new child HIV~     infections.~      Mentor Mothers (MMs) are women living with HIV who provide peer support to other HIV-positive~     women. MM programs have been incorporated into PMTCT programs in several African countries~     with some success, but with varying levels of MM training and program structure. The MoMent~     (MOther MENTor) study investigates whether highly-structured MM programs will further improve~     uptake and successful completion of PMTCT services (eg testing and appointments) in Nigeria.~     The study also evaluates the impact of structured MM programs on other outcomes, including~     facility deliveries, new infant HIV infections, infant survival and maternal viral~     suppression. Rural areas are the focus of this study because of their particularly poor~     performance in PMTCT coverage and outcomes.~   "
124584|NCT01936740|"~     The aim of this study was to compare the intraoperative efficiency, safety and postoperative~     outcomes of cataract surgery with two different high-fluidic settings.~   "
124585|NCT01936727|"~     The aim of this study was to compare the intraoperative efficiency, safety and postoperative~     outcomes of cataract surgery with two different high-fluidic settings.~   "
124586|NCT01936714|"~     The aim of this study was to compare the intraoperative efficiency, safety and postoperative~     outcomes of cataract surgery with two different high-fluidic settings.~   "
124646|NCT01935921|"~     This phase Ib trial studies the side effects and best dose of ipilimumab when given together~     with cetuximab and intensity-modulated radiation therapy (IMRT) in treating patients with~     previously untreated stage III-IVB head and neck cancer. Monoclonal antibodies, such as~     ipilimumab and cetuximab, may block tumor growth in different ways by targeting certain~     cells. Specialized radiation therapy, such as IMRT, that delivers a high dose of radiation~     directly to the tumor may kill more tumor cells and cause less damage to normal tissue.~     Giving ipilimumab together with cetuximab and IMRT may kill more tumor cells.~   "
124587|NCT01936701|"~     Age-related cataract is the main cause of impaired vision in the elderly population~     worldwide.~      The only treatment that can restore functional visual ability is cataract surgery where the~     opacified crystalline lens is removed by phacoemulsification and an artificial intraocular~     lens is implanted into the remaining capsular bag. Cataract operations are generally very~     successful, with a low risk of serious complications.~      The most common reason for impaired vision after uneventful cataract surgery in otherwise~     healthy eyes is the development of posterior capsule opacification (PCO). PCO is a~     physiological change (thickening, opacification and clouding) of the capsular bag expected~     after cataract surgery, because the lens epithelial cells (LECs) undergo hyperplasia and~     cellular migration. PCO is treated with Nd:YAG capsulotomy, a quick outpatient procedure that~     uses a laser to open a central hole in the posterior capsular bag.~      Modifications in IOL design and material lead to a decrease in the incidence of PCO.~      During the past two decades, refinements in surgical technique were made resulting in today's~     small incision phacoemulsification surgery. Nowadays a multitude of microincision IOLs are~     available, many of them similar but of course with some differences in regard to the chemical~     composition of the acrylic material and the IOL design.~      The purpose of this study is to compare the development of posterior capsule opacification~     (PCO) and the frequency of treatment between two different microincision IOLs over a period~     of 2 years.~   "
124588|NCT01936688|"~     This study is being conducted to evaluate the efficacy and safety/tolerability of SCH~     900222/MK-3222 in a population of participants with moderate-to-severe plaque psoriasis.~   "
124589|NCT01936675|"~     This study is being done to better understand how genetic information might improve~     assessment of heart attack risk.~   "
124590|NCT01936662|"~     Esophagogastroduodenoscopy (EGD) is a relatively common procedure in pediatric patients~     undergoing evaluation for various gastrointestinal ailments. The procedure itself, with or~     without associated biopsies, is relatively short in length. Unlike adults, who regularly~     undergo this procedure with conscious sedation, children most often require general~     anesthesia. While safe and effective, endotracheal tracheal tube (ETT) intubation of children~     for EGD can result in delayed awakening and slow room turnover, particularly when intravenous~     medications are required for intubation. Laryngeal mask airway (LMA) is an alternative to~     intubation, which permits removal before full awakening.~      Although considered a safe alternative to tracheal intubation in appropriate cases,~     disadvantages of the LMA have been reported including kinking, occluding view of the surgical~     field, failure of placement requiring tracheal intubation, aspiration of gastric contents,~     desaturation, and laryngospasm. The study was designed to determine whether use of an LMA for~     EGD could reduce operating room time, while providing satisfactory conditions for the~     endoscopist, and an equivalent side effect and safety profile as compared to ETT in otherwise~     healthy children with gastrointestinal complaints~   "
124591|NCT01936649|"~     The aim of the study was to assess the reproducibility of quantitative measurements of~     myocardial uptake of Iobenguane I 123 on planar and single photon emission computed~     tomography (SPECT) imaging following intravenous (i.v.) administration of AdreView. Efficacy~     was assessed based upon the absolute differences between quantitative analyses of imaging~     data on 2 scans performed 5 to 14 days apart.~   "
124592|NCT01936636|"~     This Observational Registry study is designed to collect self-reported Transmucosal Immediate~     Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) Access~     program-enrolled patient experience with breakthrough cancer pain (BTcP) as a result of~     treatment with Abstral® through the use of Quality of Life and pain measurement tools~     administered via questionnaire.~   "
124593|NCT01936623|"~     The purpose of the study is to determine whether a computerized brief intervention for~     moderate risk drug use among adult primary care patients is more effective than providing~     such patients with a substance abuse assessment alone.~   "
124594|NCT01936610|"~     In these single- blind clinical trial 67 primigravida females, gestational aged 34-36 week~     were selected using multi-stage sampling and assigned into two groups randomly.~     Decision-making (before, two weeks after and at admission in maternity department) was tested~     by a researcher -made questionnaire. In experiment group, advantages and disadvantages of~     normal delivery and cesarean-section delivery were presented by role-playing in three 90-min~     scenarios. It was also presented in a 90-min lecture. Data were analyzed using SPSS by mean~     difference test, exact fisher test, independent t-test and paired t-test.~   "
124595|NCT01936597|"~     This study must evaluate the benefit of a continuous audio guidance on the effectiveness of~     MCE directed by a volunteer.~      The evaluation of the MCE for this study is based on both quantitative criteria (based on the~     recommendations ERC 2010)~        -  frequency~        -  depth of chest compressions.~      This study compares two methods of continuous audio guide (one arm with an audio continuous~     guidance method by the regulator and second arm with an audio continuous guidance method by~     the controller relayed by an audio) to a method of incentive MCE based on a unique set made~     by the regulator(control arm).~   "
124596|NCT01936584|"~     A multicenter observational study trial validating Quality of Life assessment using EuraHS~     Quality of Life score and Carolinas Comfort scale™ in patients before and after laparoscopic~     unilateral inguinal hernia repair.~      Depending on the treating physician patients will receive a TAPP or TEP repair for their~     inguinal hernia and a self-gripping mesh will be used for the repair (Parietex Progrip Mesh).~      Primary endpoint will be assessment by the EuraHS-QoL at 1 year after laparoscopic repair of~     an unilateral inguinal hernia using the Anatomic ProGrip™ Laparoscopic self-fixating mesh.~      Secondary endpoints are assessment of the QoL 3 preoperative, 3 weeks and 1 year~     postoperative, recurrence rate at 12 months, intra-operative and post-operative~     complications, post-operative hospital stay, operation time and time to place the mesh, VAS~     (Visual Analog Scale) for pain at several control points, VRS (Verbal Rating Score) for pain~     at 3 weeks and 12 months, pain medication needed.~   "
124597|NCT01936571|"~     Lung cancer is the most common cancer type worldwide, with more than 1.1 million annual~     deaths. There are two types of the disease, namely non-small cell lung cancer (NSCLC) and~     small-cell lung cancer (SCLC), with the first accounting for 85% of the total number of~     cases. The 5-year survival across stages remains disappointingly low, around 10% in most~     countries, due to a high incidence of both loco-regional and distant failure [3]. However,~     during the last decade improved radiotherapy techniques allowed an increase of the radiation~     dose, while at the same time more effective chemo radiation schemes are being applied. These~     developments have lead to improved outcome in terms of survival. As the TNM staging system is~     highly inaccurate for the prediction of survival outcome for non-surgical patients, attempts~     have been made to develop a more accurate risk stratification for these patients [1,2]. A~     model based on clinical variables yielded an AUC of 0.74, which was encouraging, but also~     left room for improvement [2]. An extended model, which included clinical as well as~     biomarker variables, reached a higher AUC, but the limited number of patients included in~     this study made it impossible to draw definitive conclusions [1].~      New prognostic parameters can be retrieved from several sources, which include anatomic,~     molecular and functional imaging, genomics, proteomics and clinical analysis of patients. The~     unlimited amount of information is expected to lead to more accurate predictions of~     individual treatment outcome [4].~      The analysis of biomarkers, including proteins, is a fast developing, promising and~     challenging area of research. Biomarkers can measure or evaluate normal biological processes,~     pathogenic processes, or pharmacological responses to a therapeutic intervention.~     Oncoproteins are produced by, or in response to tumor cells, and may be secreted in the~     circulation of patients. As tissue sampling is often not possible in lung cancer patients,~     blood sample collection by venepuncture offers an attractive alternative, which is safe and~     easy to implement. A number of studies described the prognostic and predictive value of blood~     biomarkers for NSCLC [5-7]. In this study we will investigate the prognostic value of blood~     biomarkers related to 1) hypoxia: Osteopontin (OPN), carbonic anhydrase IX (CA-9), and~     lactate dehydrogenase (LDH); 2) inflammation - interleukin 6 (IL-6), IL-8, and C-reactive~     protein (CRP), and α-2-macroglobulin (α-2M); and 3) tumor load: Carcinoembryonic antigen~     (CEA) and cytokeratin fragment (CYFRA 21-1).~        1. Dehing-Oberije C, Aerts H, Yu S, De Ruysscher D, Menheere P, Hilvo M, et al. Development~          and validation of a prognostic model using blood biomarker information for prediction of~          survival of non-small-cell lung cancer patients treated with combined chemotherapy and~          radiation or radiotherapy alone (NCT00181519, NCT00573040, and NCT00572325). Int J~          Radiat Oncol Biol Phys. 2011 Oct 1;81(2):360-368.~        2. Dehing-Oberije C, Yu S, De Ruysscher D, Meersschout S, Van Beek K, Lievens Y, et al.~          Development and external validation of prognostic model for 2-year survival of~          non-small-cell lung cancer patients treated with chemoradiotherapy. Int J Radiat Oncol~          Biol Phys. 2009 Jun 1;74(2):355-362.~        3. Travis WD, Brambilla E, Müller-Hermelink HK, Harris CC. World Health Organization~          Classification of Tumours: Pathology and Genetics of Tumours of the Lung, Pleura, Thymus~          and Heart. Paul Kleihues MD, Leslie H. Sobin MD, editors. Lyon, France: IARC Press,~          International Agency for Research on Cancer; 2004.~        4. Lambin P, Rios-Velazquez E, Leijenaar R, Carvalho S, van Stiphout RG, Granton P, et al.~          Radiomics: extracting more information from medical images using advanced feature~          analysis. Eur J Cancer. 2012 Mar;48(4):441-446.~        5. Donati V, Boldrini L, Dell'Omodarme M, Prati MC, Faviana P, Camacci T, et al.~          Osteopontin expression and prognostic significance in non-small cell lung cancer. Clin~          Cancer Res. 2005 Sep 15;11(18):6459-6465.~        6. Muley T, Fetz TH, Dienemann H, Hoffmann H, Herth FJ, Meister M, et al. Tumor volume and~          tumor marker index based on CYFRA 21-1 and CEA are strong prognostic factors in operated~          early stage NSCLC. Lung Cancer. 2008 Jun;60(3):408-415.~        7. Pine SR, Mechanic LE, Enewold L, Chaturvedi AK, Katki HA, Zheng YL, et al. Increased~          levels of circulating interleukin 6, interleukin 8, C-reactive protein, and risk of lung~          cancer. J Natl Cancer Inst. 2011 Jul 20;103(14):1112-1122.~   "
124598|NCT01936558|"~     With the far infrared ray applied to the 'phantom limbs' in amputees and the corresponding~     normal legs in healthy subjects, the sensation of (phantom) limb will be assessed for each~     subject using the techniques of fMRI and meridian response.~   "
124647|NCT01935908|"~     The purpose of this study is to determine the feasibility of prospectively enrolling and~     randomizing patients with aneurysmal subarachnoid hemorrhage (aSAH) to receive levetiracetam~     or not to receive levetiracetam, and documenting in-hospital and follow-up clinical~     variables.~   "
124599|NCT01936545|"~     Postoperative pulmonary complications are not uncommon after liver transplantation. They can~     not only prolong the stay in intensive care unit and in hospital but also increase the~     morbidity and mortality rate. The underlying mechanisms are multifactorial, however,~     oxidative stress following hepatic ischemia reperfusion and the ensuing pulmonary leukocyte~     infiltration play an important part in the pulmonary complications. Various drugs and methods~     such as ischemic preconditioning have been used to lessen the production of oxidative free~     radicals following hepatic ischemia reperfusion. The choice of different anesthetic agents~     could aslo change the degree of production of oxygen species and antioxidant capacity during~     the operation.~      Volatile and intravenous anesthetic agents can decrease oxidative injuries through different~     mechanisms, however, which is better in preventing the pulmonary leukocyte infiltration is~     still unknown.~      We attempt the compare the oxidative stress and cytokine level in liver transplant recipients~     under desflurane or propofol anesthesia to evaluate which kind of anesthetic agent is better~     in this kind of surgery.~   "
124600|NCT01936532|"~     This is a phase II, multicenter, open-label study to evaluate the safety and efficacy of~     MLN9708 in combination with Lenalidomide and Dexamethasone in patients with newly diagnosed~     multiple myeloma. The patient population will consist of adult men and women younger than 66~     years, who have a confirmed diagnosis of MM who meet eligibility criteria.~      Following the screening period, patients will be enrolled and treated then, they will receive~     induction therapy (3 cycles), a systematic Peripheral Blood Stem Cell harvest. After~     Peripheral Blood Stem Cell Transplantation, patient will enter in the consolidation phase~     (early and late one) 2 months after transplantation. Finally, patients follow a Maintenance~     therapy (start 1 month after the last cycle of consolidation) during 12 months.~   "
124601|NCT01936519|"~     This study will examine the renal sparing impact of implementing a strategy of conversion to~     everolimus from a calcineurin inhibitor based immunosuppressive protocol at 3 months post~     liver transplant~   "
124602|NCT01936506|"~     This study is evaluating the effects of two brain training exercises on: memory, cognitive~     processing and depression symptoms.~   "
124603|NCT01936493|"~     The purpose of this study is to search for the hereditary (genetic) causes of uterine~     fibroids. Some women with uterine fibroids may have one or more genes that make them more~     likely to develop uterine fibroids. We are trying to identify these genes to better~     understand how and why uterine fibroids develop and to design better treatment options for~     women with uterine fibroids. This information may also help us to understand and treat other~     problems that may be caused by these genes.~   "
124604|NCT01936480|"~     The purpose of this study is to assess the ability of common genetic variants in aggregate to~     predict drug-induced QT prolongation in healthy subjects using moxifloxacin.~   "
124605|NCT01936467|"~     The aim of this study is to compare Endoscopic Ultrasound and Fine Needle Aspirate with a~     standard 22-gauge needle using either standard-suction or capillary suction methods for~     solid pancreatic lesions. Investigators hope to discover the best technique for obtaining~     diagnostic material when patients with a pancreatic mass undergo endoscopic ultrasound and~     fine needle aspirate procedure.~      There are currently several techniques for obtaining tissue during endoscopic ultrasound and~     fine needle aspirate. The procedure will be performed by either the capillary suction~     technique or no suction technique.~   "
124606|NCT01936454|"~     A cohort study to Evaluate the contraceptive effectiveness of Sino-implant (II) during the~     3rd and 4th years of use in Chinese women~   "
124607|NCT01936441|"~     Self-reported sleep complaints are common in peri- and postmenopausal women and have been~     identified as a key symptom of the menopausal transition. The MsFLASH study, A Pilot Trial of~     Telephone-Based Cognitive-Behavioral Therapy for Midlife Women with Menopause-related Sleep~     Disturbance, is a randomized, single-blind, placebo-controlled, two arm clinical trial. The~     target population will include women in general good health, aged 40-65 years, who report~     symptoms of insomnia (trouble sleeping) and who are bothered by hot flashes. We plan to~     enroll 100 women from Seattle, Washington and surrounding areas into the trial. Half of the~     women will be randomly assigned to receive the behavioral intervention and half to receive~     the behavioral control.~      The intervention arm participants will receive 6 sessions of a telephone-based,~     cognitive-behavioral therapy intervention for insomnia (CBT-I), based on state-of-the-art~     methods and specifically targeted to women with menopause-related sleep disturbance (CBT-I).~     The control arm participants will receive telephone-based Menopause Education Control (MEC)~     that includes elements of sleep hygiene. Assessments for both groups will be collected at~     baseline (pre-randomization), 8-week post-randomization, and 6-month post-randomization.~      The inclusion/exclusion criteria are designed to target broadly those midlife women who have~     menopause-related sleep disturbance and also report being bothered by vasomotor symptoms.~     This target population defines the clinical population seeking treatment for relief of~     menopause-related sleep problems. Exclusion criteria are kept minimal and intended only to~     exclude women with significant medical problems likely to account for their sleep problems~     (instead of menopause), or likely to interfere with their ability to participate in the~     intervention. We include women taking hormone therapy or other medication who meet these~     criteria because they are part of the population seeking clinical care for relief of sleep~     disturbances.~      Our primary objective is to develop an intervention that is generalizable to the greatest~     number of women and maximally translatable into real-world primary care practice.~   "
124608|NCT01936428|"~     The purpose of this study is to evaluate (thanks to analysed interview) the perception of~     palliative care by relatives of patients treated in oncology.~   "
124609|NCT01936415|"~     In a prospective randomised study two uncemented tibial components with different coating~     (Vanguard® porous coating, Biomet and Regenerex® Primary Tibial Tray, Trabecular Metal~     coating, Biomet) used for total knee arthroplasty (TKA) are evaluated. Both tibial component~     coatings are designed to provide excellent conditions for bone ingrowth.~      The differences between the two tibial components are evaluated by measurements of migration~     of the tibial component assessed by Radiostereometric analysis (RSA) and measurements of the~     adaptive bone remodeling of the proximal tibial assessed by dual energy X-ray absorptiometry~     (DEXA).~   "
124610|NCT01936402|"~     Unlikely the other element for high quality chest compression during Cardiopulmonary~     resuscitation(i.e. compression rate, chest recoil, hand position), chest compression depth~     (CCD) is influenced by surface on which the patient is placed, especially in hospital. For~     solving this problem, to place the patient on rigid surface, use a backboard that might~     decrease the mattress compression, receive a feedback that reflects the mattress compression~     depth (MCD) using dual accelerometer or magnetic sensor have been proposed. As the other~     solution, we hypothesized that training of 6-7cm CCD for healthcare providers improve~     accurate CCD during cardiopulmonary resuscitation when manikin is placed on mattress in~     hospital.~   "
124660|NCT01935739|"~     The purpose of this study is to determine discordant HER2/neu status of primary breast tumor~     and metastatic breast cancer cells at regional lymph nodes in node positive breast cancer~     patients.~   "
124611|NCT01936389|"~     Glaucoma is the world's the second leading cause of irreversible blindness. The World Health~     Organization (WHO) estimated the incidence of blindness due to glaucoma to be 4.4 million~     people worldwide in 2002. Intraocular pressure (IOP) is the sole proven modifiable risk~     factor for the development and progression of glaucomatous optic neuropathy. Medical therapy~     is aimed at lowering IOP in order to prevent or slow progression.~      Exfoliation syndrome (XFS) is the most common identifiable cause of open-angle glaucoma,~     affecting an estimated 60 to 70 million people worldwide. Approximately two-thirds of~     patients have disease in only one eye on clinical examination; however, XFS is detectable in~     the other eye with conjunctival biopsy. XFS is also a systemic disease, with effects on the~     cardiovascular and cerebrovascular systems.~      Patients with XFS are twice as likely to convert from ocular hypertension to glaucoma.~     Glaucoma in XFS is more severe than primary open angle glaucoma. There is greater diurnal IOP~     fluctuation, greater visual field loss and optic nerve head damage at the time of diagnosis,~     poorer response to medications, more rapid visual field progression and more frequent need~     for surgery.~      Because you meet eligibility criteria for our study, we ask for your consent to participate~     in the study described below. In brief, you will be taking an investigational drug (AR-12286,~     rho-kinase Inhibitor) at either 0.5% or 0.7% once a day for 6 months. This drug is currently~     being tested in patients with primary open-angle glaucoma, but not yet in glaucoma in~     exfoliation syndrome. Because of the mechanism of glaucoma in XFS and the mechanism of action~     of rho-kinase inhibitors, there is reason to think it would be more effective in eyes with~     XFS and glaucoma than in primary open-angle glaucoma (ordinary glaucoma). There will be a~     baseline and study day 1 visit, week 1 visit, month 1 and 3 visit, week 13 visit, month 6~     visit and a week 25 visit; for a total of 7 office visits.~   "
124612|NCT01936376|"~     The project is designed to test new biomarkers that are more sensitive than the current~     standard in detecting injury to the proximal kidney tubule and will establish better criteria~     for when kidney safety concerns may halt further testing of a drug in humans.~   "
124613|NCT01936363|"~     This is a double blind, randomized, placebo-controlled, 2-arm, Phase 2 trial investigating~     the efficacy and safety of combination therapy of pimasertib plus SAR245409 and pimasertib~     placebo administered once per day compared to pimasertib administered twice per day plus~     SAR245409 placebo administered once per day in subjects with previously treated unresectable~     low-grade serous ovarian or peritoneal carcinoma or serous borderline ovarian or peritoneal~     tumors.~   "
124614|NCT01936350|"~     Twenty-four patients with known heart failure will be recruited. They will undergo a cardiac~     magnetic resonance for ventricular analyses and after this first exam they will be randomized~     to placebo or Sildenafil. After one hour drug intake they will undergo another cardiac~     magnetic resonance to evaluate the drug impact on right and left ventricular function.~   "
124615|NCT01936337|"~     In this study, the safety, tolerability and efficacy of DLX105 administered topically onto~     the psoriatic lesion of mild-to-moderate psoriasis patients will be investigated.~   "
124616|NCT01936324|"~     The purpose of this study is to determine the safety and tolerability of DRM01B topical in~     healthy volunteers. Following review of safety data, this study will determine the safety,~     tolerability and preliminary efficacy of DRM01B Topical Gel in subjects with acne vulgaris~   "
124617|NCT01936311|"~     The purpose of this study is to test whether having patients identify a self-management goal~     (health goal), prior to a visit with their primary care provider, leads to health behavior~     improvement over six weeks.~   "
124618|NCT01936298|"~     The investigators evaluate the effectiveness of the application of continuous passive motion~     device for hand rehabilitation in two classes of patients: with a residual active motion and~     without a residual active motion.~   "
124619|NCT01936285|"~     -  There is evidence that inflammatory processes may play detrimental role during the acute~          phase of myocardial infarction~        -  The hypothesis of this study is that colchicine, by its anti-inflammatory action, may~          lead to reduction in infarct size, when administered during the acute phase of~          myocardial infarction~   "
124620|NCT01936272|"~     Two treatment options exist for infant patients with hydrocephalus. Most patients are treated~     with a surgical procedure in which a shunt is inserted into the brain and abdomen. In recent~     years, however, another treatment has developed called Endoscopic Third Ventriculostomy (ETV)~     with Choroid Plexus Cauterization (ETV/CPC).This research study is being done to measure the~     results of these procedures in children less than six months of age who have hydrocephalus as~     the result of a brain infection, called post-infectious hydrocephalus, or PIH. This study~     will evaluate patients in more detail to measure brain growth and development.~   "
124621|NCT01936246|"~     To date, few studies have been done regarding nutrition supplementation in infants with brain~     injury. Therefore, the investigators are proposing to study the effects of protein~     supplementation in this group of babies. The investigators will recruit 24 infants with brain~     injury (evidence of hemorrhage, white matter injury, or gray matter injury) admitted to the~     Cincinnati Children's Hospital Neonatal Intensive Care Unit (NICU) into the study. Upon~     diagnosis, the investigators will obtain consent from the parents for participation in the~     study, then randomly assign the baby to one of two groups - an increased protein group and a~     control group. Both groups of infants will be monitored to ensure no adverse effects occur~     due to the supplementation.~      Protein supplementation will continue for the first 12 months of age. Growth parameters, such~     as weight, length, and head circumference, will be measured while the infant is the NICU.~     Head circumference will be measured in the investigators outpatient clinic at three, six, and~     12 months of age. At 18-22 months, the infants will be tested for neurodevelopmental outcomes~     using the Bayley Scales of Infant Development. The investigators hypothesize that infants who~     receive the additional protein will demonstrate increased head growth and improved~     neurodevelopmental outcomes.~   "
124622|NCT01936233|"~     Sustained chronic hepatitis B virus inflammation is a major cause of liver cancer occurrence~     and development. Antiviral treatment can block the persistent infection. Aspirin can inhibit~     platelet function and CD8 + T cell mediated liver cell necrosis and inflammation. Aspirin~     also can inhibit liver cancer cells metastasis through inhibit COX2.~   "
124623|NCT01936220|"~     Objective: to evaluate the effectiveness of specialised and sustained intervention with or~     without parent groups during the initial phase of schizophrenia or related disorders on~     relapse prevention~      Methods: A three conditions randomized trial with a duration of five years~      Participants: 200 consecutively referred patients aged 15-28 years with a first psychotic~     episode of schizophrenia or related disorder~      Treatment-conditions: Specialized Treatment of early schizophrenia (ST), ST including Parent~     groups (ST+P) and Treatment As Usual (TAU).~      Outcome-measures: cumulative relapse rates and time to first relapse after first remission.~     Secondary outcome measure: social functioning.~      Statistical analysis: cumulative relapse rates using life-table methods. The effect of the~     three interventions on time to first relapse after remission will be compared using Cox~     regression analysing intention to treat (ITT) grouping.~   "
124624|NCT01936207|"~     IC-GLOSSARI (The Intensive Care GLObal Study on Severe Acute Respiratory Infection) is a~     multicentre, prospective, observational,14-day inception cohort study designed and conducted~     by the ESICM Trials Group to investigate the epidemiology and microbiology profiles of~     ICU-SARI, document commonly used treatment and monitoring strategies, measure current~     outcomes and identify potential topics for multidisciplinary studies ranging from~     interventional clinical trials to fundamental mechanisms of disease.~      The purpose of this study is to answer the following questions:~      What is the frequency and disease burden of SARI for ICU's worldwide? What are the~     aetiologies of ICU SARI? How are SARI patients diagnosed and managed in the ICU? What is the~     outcome from SARI in the ICU? Is there a difference in outcomes from SARI depending on the~     aetiology of the disease? Can we identify high-risk categories of SARI that could constitute~     a defined population for an interventional study?~   "
124625|NCT01936194|"~     This clinical trial will study the effects of PUFA supplementation during pregnancy and~     lactation period on fatty acid composition in human milk and plasma of the mothers and the~     clinical outcome of atopic dermatitis in infants at increased risk.~   "
124626|NCT01936181|"~     This is a randomized, double-blind, parallel group, multicentre clinical study to evaluate~     the efficacy, safety, pharmacokinetics and immunogenicity of SB2 compared to Remicade in~     subjects with moderate to severe Rheumatoid Arthritis (RA) despite Methotrexate (MTX)~     therapy.~   "
124627|NCT01936168|"~     The newly developed Mechanochemical Endovenous Ablation (MOCA) device uses a technique that~     combines mechanical endothelial damage using a rotating wire with the infusion of a liquid~     sclerosant. Heating of the vein and tumescent anesthesia are not required; only local~     anesthesia is utilized at the insertion site. Previously we showed that endovenous MOCA,~     using polidocanol, is feasible and safe in the treatment of great spahenous vein (GSV)~     incompetence. However, larger studies with a prolonged follow-up to prove the efficacy of~     this technique in terms of obliteration rates are lacking. This randomized trial was designed~     to compare occlusion rate, post-operative pain and complications between radiofrequency~     ablation (RFA: the current treatment for GSV incompetence) en MOCA.~   "
124628|NCT01936155|"~     Neuromuscular Electrical Stimulation (NMES) will be facilitated through the use of a~     stimulator, with the patient in a semi recumbent position, using UltraStim electrodes. Two 5~     cm x 5 cm electrodes will be placed over the soleus muscle for calf stimulation. The~     participant will be allowed to ramp up the stimulus level themselves to get used to the~     sensation and determine their maximum tolerated stimulus level.~      A goniometer will be used to assess mobility at the knee and ankle joints. Transcutaneous~     oxygen measurements (tcpO2) will be assessed using the PERIMED Periflux System 500 tcpO2~     monitor.~      The level of oedema will be measured using the figure of eight measurement, tape~     circumference measurement and water displacement measurement.~      Comfort will also be assessed by use of a 100mm non-hatched visual analogue scale (VAS). Each~     participant will be asked to indicate their level of comfort following the application of~     NMES.~   "
124629|NCT01936142|"~     The purpose of this study is to determine whether the use of RenalGuard system which creates~     high urine output with fluid balancing may prevent contrast induced nephropathy in patient~     undergoing cardiac resynchronization therapy (CRT) implantation.~   "
124630|NCT01936129|"~     This is a randomised controlled trial to assess the neuroprotective effect of Cop-1~     (Copaxone) in patients with acute primary angle closure (APAC). The standardized management~     of APAC will include medical therapy to reduce intraocular pressure (IOP), followed by laser~     peripheral iridotomy. Cop-1 will be administered in addition to standard therapy as a~     subcutaneous dose once within 24 hours of presentation, and then one week later (total 2~     injections). The control group will have placebo in addition to standard regimen. Subjects in~     the study will have visual field test performed with the Humphrey Visual Field Analyzer II,~     retinal nerve fibre layer (RNFL) thickness measured with the Stratus optical coherence~     tomography (OCT) and Optic nerve head evaluated with the Heidelberg retinal tomography (HRT).~     At least 2 baseline visual field tests will also be performed in the first week. Subsequent~     visits will be at week 4, 8, 12 and 16. The outcome criteria will be difference in visual~     field, RNFL thickness, and optic nerve head structural changes.~   "
124631|NCT01936116|"~     Saline infusion sonohysterography and other intrauterine investigations methods may cause~     uterine cramping, pain and vasovagal reactions. According to few of previous studies the~     position of catheter placement can affect the magnitude of pain and amount of saline required~     during the sonohysterography. The purpose of this double blind control trial study is to~     assess whether the location of the balloon catheter either the uterus or cervix during~     sonohysterography can affect the magnitude of pain and the rate of vasovagal reaction.~   "
124632|NCT01936103|"~     First acute anterior myocardial infarction in patients with primary PCI preoperative and~     postoperative 30 days intensive dose atorvastatin statin therapy compared with conventional~     -dose therapy , patients can improve left ventricular function , reduce major adverse~     cardiovascular events .~   "
124633|NCT01936090|"~     This phase I/II trial studies the side effects and best dose of bortezomib when given~     together with melphalan, and total-body irradiation before stem cell transplant and to see~     how well it works in treating patients with multiple myeloma. Giving chemotherapy and~     total-body irradiation before a stem cell transplant stops the growth of cancer cells by~     stopping them from dividing or killing them. The stem cells that were collected from the~     patient's blood or bone marrow are returned to the patient to replace the blood-forming cells~     that were destroyed by the chemotherapy and total-body irradiation.~   "
124661|NCT01935726|"~     As the name states, contact registries securely store contact information from groups of~     reasonably well-characterized patients (or primary supporters/caregivers) who are interested~     in being informed about ongoing or future research opportunities. Pulmonary fibrosis (PF) is~     a condition for which effective therapies have remained elusive, making drug trials and~     interventional research studies a mainstay in the PF arena over the last decade and for the~     foreseeable future. A PF Contact Registry will be a conduit to collect, analyze, and~     disseminate de-identified, group-level data on the clinical phenotypes of PF patients and~     will house contact information from patients who wish to be informed about research~     opportunities for which they may qualify. Data contained in the Registry will help inform~     research hypotheses and guide investigators as they develop research protocols by providing~     them with numbers of potential subjects who meet particular inclusion/exclusion criteria.~   "
124634|NCT01936077|"~     The ideal stimulation protocol for ovarian stimulation is under constant debate, as we gain~     more pharmacological control over the patient hormonal milieu. Specifically, the debate~     focuses around the ideal LH levels. The concept of an LH window was suggested.~      The need for a threshold level of LH is clearly demonstrated in hypogonado-tropic~     hypogonadism patients, but also in cycling patients receiving high doses of GnRH antagonist.~     The Ganirelix dose finding study demonstrated very low implantation rates in the high dose~     groups (1 mg, 2 mg).~      The stimulation dynamics in these patients were remarkable for very low E2 and LH levels on~     the day of hCG. In fact, a functional state of hypogonadotropic hypogonadism is achieved,~     explaining the poor clinical results (1.5% implantation rate under 2 mg Ganirelix). The same~     protocol was repeated with added Luveris resulting in excellent pregnancy rates.~      The recommended daily dose of GnRH antagonist is 0.25 mg which on the average provides a~     protection from premature LH surge, with moderate suppression of LH. Therefore, most patients~     do not need supplemented LH after the antagonist is initiated.~      However, there is a subgroup of patients who hyper-respond to the antagonist (in 0.25 mg~     dose) with a sharp decrease in LH. This explains contradictory findings in the available~     studies. The basic assumption in the background of this proposal is that there is a wide~     range of pituitary responses to GnRH antagonist. Obeying a bell-shape curve, most women have~     an average response, however, some hypo-respond might ovulate prematurely, and others~     hyper-respond. In the latter cases, pituitary response will behave as if exposed to a higher~     dose.~      How to identify an exposure to a presumed higher dose?~      Below is a figure from the original paper. A close look indicates that the immediate response~     to all Ganirelix doses are similar in terms of LH drop, however, the big difference lies in~     the pituitary recovery 24 hours post Ganirelix dose.~      While small doses allow for a quick recovery to almost pre-treatment LH levels, high doses~     result in incomplete recovery. Hence, it is reasonable to speculate that the high response to~     0.25 mg dose will lead to slow or incomplete recovery of LH levels 24 hours post the initial~     dose.~      It is estimated that about 15% of patients are antagonist hyper-responders. Efforts to~     individualize patient protocol must target this group as candidates for supplemented LH. This~     estimate is similar to study findings: Huirne et al Human Reproduction 2005, 20: 359.~   "
124635|NCT01936064|"~     To determine the effective functionality/potency of Jobelyn as an immunologic and~     haematologic booster in Breast cancer patients (start-off), thus improving the outlook and~     the quality of life of such patients generally~   "
124636|NCT01936051|"~     To modeling the pharmacokinetic-pharmacodynamic(PK-PD) simulation with the plasma~     concentration and the transporter occupancy from OCD patients treated with escitalopram.~      To examine the effect of G2677T/A single nucleotide polymorphism(SNP) of ABCB1 gene to the~     PK-PD modeling in OCD patients treated with escitalopram.~   "
124637|NCT01936038|"~     The obstructive sleep apnoea/hypopnoea syndrome (OSAHS) is a breathing disorder which happens~     at night and consists of the interruption of airflow for more than five seconds. His current~     treatment by continuous positive pressure nocturnal machine (CPAP) is not curative and~     therefore the level of compliance is key to patient improvement. Many patients don´t tolerate~     CPAP by the numerous side effects involved. The Upper Airway Toning is a compendium of~     non-invasive techniques that aim to assist tolerance and compliance with the CPAP. These~     techniques are: oropharyngeal exercises executed actively by the patient for the muscle~     toning of the upper airways, electrostimulation of the muscles in the floor of the mouth,~     correction of the tongue position, nasal and bronchial fogging, execution of respiratory~     gymnastics, therapy myofascial in the oropharyngeal muscles, manual therapy in the cervical~     column,and massage in the diaphragm. All the techniques together seek for a greater or lesser~     impact on the upper airways hypotony, the hypotony of the tongue and the soft palate, the jaw~     retrognathism, the mouth breathing, the vertebrobasilar syndrome, the gastroesophageal~     reflux, the excessive accumulation of secretions in the upper and lower airways, the~     obstructive and restrictive respiratory problems, the sleeping posture, the hypertonia of the~     diaphragm due to the excess effort in trying to overcome the respiratory obstruction. All~     these disfunctions will make easier for the patient to show side effects in the use of CPAP.~     There will be a double-blind randomized controlled study with 110 individuals. One group will~     follow the conventional medical treatment with CPAP and the other group medical treatment~     plus Upper Airway Toning. After six months, the mean improvement between the two groups will~     be compared.~   "
124638|NCT01936025|"~     The study has a randomized, double-blind, placebo-controlled, double dummy and eight-way~     cross-over design. Males with T2DM on a stable metformin monotherapy will be screened for~     participation in the study. Eligible subjects will be randomized to receive DXM 30 mg, DXM 60~     mg, DXM 90 mg alone or in combination with sitagliptin 100 mg, sitagliptin 100 mg alone, or~     placebo (for DXM and sitagliptin) on in total eight treatment days. An OGTT will be started 1~     hour after study drug administration and blood glucose will be measured over the next 4~     hours. There will be a 3 to 14-day washout period between doses.~   "
124639|NCT01936012|"~     The present study was conducted to find out whether the bioavailability of 10 mg lisinopril~     tablets produced by PT Dexa Medica was equivalent to the tablets produced by the innovator~     (Zestril® 10 mg, PT Boehringer Ingelheim Indonesia, Indonesia, under license from Astra~     Zeneca UK Ltd.)~   "
124640|NCT01935999|"~     A study to assess the safety and performance of an enhanced one piece closed pouch in a 12~     subjects with a colostomy.~   "
124641|NCT01935986|"~     The purpose of this study is to study the effect of a probiotic on protection against upper~     respiratory tract infections (URTI) in children.~   "
124642|NCT01935973|"~     This randomized phase I trial studies how well trametinib with or without GSK 2141795~     (protein kinase B [Akt] inhibitor GSK2141795) works in treating patients with endometrial~     cancer that has come back (recurrent) or does not go to remission despite treatment~     (persistent). Trametinib and Akt inhibitor GSK2141795 may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. It is not yet known whether trametinib~     is a more effective treatment for endometrial cancer when given with or without ATK inhibitor~     GSK2141795.~   "
124643|NCT01935960|"~     This randomized phase I trial studies the side effects and best dose of retinoid 9cUAB30 in~     preventing cancer in healthy volunteers. The use of retinoid 9cUAB30 may keep cancer from~     forming in healthy volunteers.~   "
124644|NCT01935947|"~     This randomized phase II trial studies how well azacitidine and entinostat before~     chemotherapy works in treating patients with non-small cell lung cancer that has spread to~     other places in the body. Drugs used in chemotherapy, such as azacitidine, irinotecan~     hydrochloride, gemcitabine hydrochloride, docetaxel, and pemetrexed disodium, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Entinostat may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. Giving azacitidine and~     entinostat before chemotherapy may work better in treating patients with non-small cell lung~     cancer.~   "
124645|NCT01935934|"~     This phase II trial studies how well cabozantinib s-malate works in treating patients with~     endometrial cancer that has come back (recurrent) or has spread to other places in the body~     (metastatic). Cabozantinib s-malate may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth and by blocking blood flow to the tumor.~   "
124648|NCT01935895|"~     Introduction: Daily stress levels of population are increasing over the last decades.~     Frequent spouse to stress is considered an important risk factor for development of~     cardiovascular diseases. Other well documented risk factor for cardiovascular diseases is~     systemic hypertension which, in turn, has been related to elevated blood pressure reactivity~     (BPR) to stress. The exacerbated BPR may suggest a poor autonomic modulation due to an~     elevated sympathetic tone, condition that has been associated with medium to long-term~     cardiovascular complications. Also, some reports have demonstrated that individuals~     hyper-reactive to stress chronically increase their risk for psychological disorders such as~     anxiety, irritability and frustration. These feelings are associated to increased sympathetic~     tone induced chronic elevation in BP. Although the hemodynamic benefits of aerobic and~     resistance exercises had been documented in a variety of reports5, the acute effects of the~     aforementioned exercise modes combined in a circuit method on post-exercise BP, including the~     responses to cardiovascular stressor test need further investigations. Objective: To~     investigate the blood pressure (BP) responses to cardiovascular stressor test after a~     combined exercise circuit session at moderate intensity. Methods: Twenty individuals~     (10male/10fem; 33.4±6.9years; 70.2±15.8kg; 170.4±11.5cm; 22.3±6.8 %body fat) volunteered to~     randomly perform on different days: 1) Exercise session consisting of 3-laps in a circuit~     model in the following sequence: knee extension, bench press, knee flexion, rowing in the~     prone, squat, shoulder press and 5-min of aerobic exercise at 75-85% of age-predicted maximum~     heart rate and/or 13 in the Borg-Scale [6-20]. The sets of resistance exercise were composed~     by 15 repetitions with ~50% of one repetition maximum test and; 2) a control session without~     exercise. The systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured~     at resting and during 1h of recovery in both experimental sessions. After that, blood~     pressure reactivity (BPR) was evaluated using the Cold Pressor Test (a test with hand in the~     cold water during one minute). The hypotheses are that after doing the exercise session occur~     attenuation of blood pressure increase during the Cold Pressor Test compared to sitting~     without exercise (control session).~   "
124649|NCT01935882|"~     Primaquine (PQ) is currently the only available drug that can clear mature transmission~     stages of P. falciparum parasites. PQ was previously shown to clear gametocytes that persist~     after artemisinin-combination therapy. However, there are safety concerns about the use of PQ~     at the currently recommended dose of 0.75mg/kg in individuals who are glucose-6-phosphate~     dehydrogenase (G6PD) deficient. PQ causes transient but significant haemolysis in G6PD~     deficient individuals; this side-effect is dose dependent. There are indications that a lower~     dosing of PQ may effectively reduce gametocyte carriage but the lowest efficacious dose for~     gametocyte clearance is currently unknown. Recently, the World Health Organization changed~     their recommendation to a low dose of primaquine, 0.25mg/kg. However, there is no direct~     evidence on the extent to which (low dose) PQ prevents malaria transmission to mosquitoes and~     what the lowest efficacious dose is.~      In the current study we aim to identify the lowest efficacious dose of PQ in individuals with~     normal G6PD function. Children with asymptomatic malaria and normal G6PD enzyme function will~     be randomized to treatment with artemether-lumefantrine alone or in combination with low~     doses of PQ. All enrolled individuals will receive a full three-day course of AL, and will be~     randomized to receive a dose of primaquine or placebo with their fifth dose of AL. Efficacy~     will be determined based on gametocyte carriage during follow-up, measured by molecular~     methods. For a subset of participants with patent gametocytes, primaquine effect on~     infectivity to mosquitoes will be assessed by membrane feeding assays~   "
124650|NCT01935869|"~     The purpose of this study is to determine the skin irritation potential and sensitisation~     potential of LEO 90100 and the vehicle after repeated applications on the skin of healthy~     subjects.~   "
124651|NCT01935856|"~     This study is designed to evaluate safety, pharmacokinetics and pharmacodynamics after single~     and multiple administration of KHK7580 for secondary hyperparathyroidism in patients~     receiving hemodialysis~   "
124652|NCT01935843|"~     RATINALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory~     into patient autologous T cells may make the body build immune response to kill cancer cells.~      PURPOSE: This clinical trial is to study genetically engineered lymphocyte therapy in~     treating patients with HER-2 positive advanced solid tumors,such as breast cancer, gastric~     cancer, hepatic carcinoma, endometrial cancer and ovary cancer.~   "
124653|NCT01935830|"~     The purpose of this study is to determine the effects of the antiretroviral drugs efavirenz~     and ritonavir on human brain LAAM disposition in vivo.~   "
124654|NCT01935817|"~     Chronic hepatitis C is both a virologic and a fibrotic disease, with mortality resulting~     mainly from the complications of cirrhosis and HCC.~      The investigators' aim will be to evaluate the impact on of supplementation with a new~     pharmaceutical complex of silybin-vitamin E-phospholipids in patients with chronic hepatitis~     C treated with Pegylated-Interferon-α2b plus Ribavirin.~   "
124655|NCT01935804|"~     The study tests whether pioglitazone (PIO)as compared to metformin (MET)affects bone health~     including bone mineral density, bone turnover markers, and osteocyte biomarker in patients~     with type 2 diabetes (T2DM).~   "
124656|NCT01935791|"~     The purpose of this study is to determine what can activate brown adipose tissue (BAT).~   "
124657|NCT01935778|"~     The role of post surgery adjuvant chemotherapy is becoming more and more important in AGC~     (advance gastric cancer). S-1 and combined therapy of Capecitabine and Oxaliplatin are~     currently accepted as a standard therapy among the AGC patients who were performed~     gastrectomy from the D2 surgery. However, many improvements will be needed in stage IIIB and~     IV. Combined chemotherapy of Docetaxel, Capecitabine, and Oxaliplatin may be considered as~     one of the best treatments for IIB and IV(M0) stage AGC patients who were performed~     gastrectomy.~   "
124658|NCT01935765|"~     Sleep apnea syndrome is strongly associated to type 2 diabet, partly and this is partly due~     to obesity. Treatment of sleep apnea may improve hypertension, cardiovascular risk and in~     some studies diabetes status. Few data are available for type 1 diabetes but suggest that the~     prevalence of sleep apnea syndrome may be high. We plan to compare the prevalence of sleep~     apnea syndrome assessed by polysomnography in a sample of type 1 diabetic patients and a~     control group matched by age, gender and body mass index. The secondary objective is to~     determine if the presence of an autonomic neuropathy or poorly controlled diabetes (assessed~     by glycosylated haemoglobin) may or not contribute to the presence of sleep apnea in the~     diabetic group.~   "
124659|NCT01935752|"~     Fibromuscular dysplasia is an non inflammatory non atherosclerotic obstructive arterial~     disease affecting mid-size arteries. It is considered as a rare vascular disease of unknown~     origin. Fibromuscular dysplasia may become symptomatic depending on location and severity of~     narrowing of the arterial lumen. for example,when a stenosis develops within a renal artery,~     arterial hypertension may develop. The cause of fibromuscular dysplasia is unknown. Several~     factors have been suggested to be associated with it: tobacco abuse or oestrogens. In order~     to progress into identifying possible causative mechanisms of the disease, we design a~     pathophysiology study destined to assess endothelial function in patients with fibromuscular~     dysplasia and to identify possible plasmatic biomarkers of the disease.~   "
124664|NCT01935687|"~     The purpose of this study is to validate an instrumented wheel such as a new biomedical~     device. The physicians will compare this instrumented wheel with another instrumentation~     Ergometer roller, each patient will try the both instrumentations, physical and~     physiological parameters will be measured.~      The increase rate of radial power during the cardiac stress test may be more important when~     the physicians use the instrumented wheel.~   "
124665|NCT01935674|"~     To compare the effect of rosuvastatin to protease inhibitor switching on fasting total~     cholesterol over 12 weeks.~   "
124666|NCT01935661|"~     β-thalassemia syndromes are a group of hereditary disorders characterized by a genetic~     deficiency in the synthesis of beta-globin chains.~      In recent studies done in β-thalassemia major patients abnormal iron deposition was evident~     using MRI in brain structures, cortex, putamen, and caudate nucleus . In most of the cases~     the neurological involvement is subclinical. Cognitive functioning was evaluated in beta~     thalassemia major, compared with healthy controls, using a neuropsychological battery~     including tests of abstract reasoning, attention, executive functions, language,~     constructional/visuospatial skills, and memory. Patients with beta thalassemia major, in~     particular those showing signs of hemosiderosis, had significantly impaired function in all~     neuropsychological tests. There was no relationship between cognitive performances and signs~     of deferoxamine toxicity, deferoxamine dosage, and levels of hemoglobin and ferritin.~     Event-related potentials (ERPs) are one of the most informative and dynamic methods of~     monitoring the information stream in the living brain. ERPs are linked in time with a~     physical or mental event, and are typically extracted from the scalp-recorded~     electroencephalogram (EEG) by means of signal averaging.~      ERPs have been used in the assessment of cognitive function in several disorders, including~     anemia and iron deficiency anemia. However, literature regarding cognitive function and ERP~     activity in thalassemia patients is extremely limited, especially in adults.~      The purpose of this study is to evaluate the cognitive and brain function in a group of 60~     thalassemia patients and compare the results to healthy controls.~   "
124667|NCT01935648|"~     The primary goal is to evaluate ropivacaine blood concentrations during and after local~     anaesthetic (ropivacaine) infiltration - the Caledonian technique - for total knee~     replacement surgery. The investigators plan to measure these levels by testing blood samples~     taken over a timed period.~      This will allow us to confirm whether the current regimen of local anaesthetic use is within~     safe limits.~   "
124668|NCT01935635|"~     The purpose of this study is to investigate whether HB-Vac Activated-DCs Combined With~     Peg-IFN or NAs has more efficacy than Peg-IFN or NAs alone in the treatment of chronic~     hepatitis B patients~   "
124669|NCT01935622|"~     Non-ischemic cardiomyopathy and heart failure are highly influenced by the presence of~     systemic inflammation.~      Doxycycline is a FDA-approved drug to treat bacterial infections which also shows powerful~     anti-inflammatory effects.~      In this study we plan to determine the effects of Doxycycline in patients with stable heart~     failure and non-ischemic cardiomyopathy on peak of aerobic exercise capacity (peak V02) and~     ventilator efficiency measured with a cardiopulmonary test.~   "
124670|NCT01935609|"~     1. To evaluate the efficacy of a structured outpatient couples intervention program~          (Therapeutic Couples Intervention, TCI) on couples' marital quality after acquired brain~          injury (ABI).~        2. To assess the impact of the TCI on the emotional well-being of persons with ABI and~          their partners.~        3. To ascertain the impact of the TCI on caregiver burden and unmet needs as reported by~          partners of persons with ABI.~        4. To examine the extent to which treatment benefits for survivors and their caregiving~          partners are sustained in the longer-term.~   "
124671|NCT01935596|"~     This is a Biomedical Research, prospective, randomized, double blind, controlled monocentric,~     phase IV comparison of the effects of two local anesthetics intrathecally: 0.5%~     levobupivacaine and ropivacaine 0.5%.~   "
124672|NCT01935583|"~     1. To evaluate the short and longer-term efficacy of a structured outpatient intervention~          program (The Resilience and Adjustment Intervention, RAI) to improve survivors'~          resilience.~        2. To evaluate the impact of treatment on emotional well-being and postinjury adjustment.~        3. To evaluate the impact of the intervention on abilities including problem solving,~          communication, and stress management.~        4. To examine the extent to which treatment benefits are sustained in the longer-term.~   "
124673|NCT01935570|"~     This clinical study is composed of two steps. The first step aims at validating the~     pharmacokinetic approach based on the magnesium concentration in erythrocyte and plasma.~      According to these results and if this pharmacokinetic approach is validated, the second step~     will set up. The second phase aims at comparing the relative bioavailability of magnesium~     administrated by two different drug formulations: ChronoMag Smart Tablet® (two tablets50mg)~     versus Mag2® (three tablets100mg).~   "
124674|NCT01935557|"~     Optimal anticoagulation using heparin with close attention to maintain therapeutic dosing~     during the procedure is important.~      Randomized comparison of continuous and intermittent heparin infusion during catheter~     ablation of Atrial Fibrillation.~   "
124675|NCT01935544|"~     Botulinum toxin injections are an effective treatment of limb spasticity after stroke.~     Different tracking techniques are used to locate a proper injection spot. Palpatory technique~     is barely effective and induces a high risk of error. Localization by electro stimulation is~     frequently used in adults, but often requires multiple painful repositioning of the needle.~     Ultrasound tracking is sometimes used in children but not much in adults.~      The advantages of ultrasound-guided botulinum toxin injections are a painless localization~     and greater injection accuracy. Safety is therefore enhanced since intravascular injection is~     easily avoided.~      The few existing publications on the subject are essentially case reports. Few studies have~     focused on comparing different injection techniques and so far, no well-conducted study has~     highlighted superior efficiency of ultrasound-guided injections.~   "
124782|NCT01934140|"~     The purpose of this study is to evaluate the long-term antibody persistence from 6, 7, 8, 9~     to 10 years post-administration of MenACWY-TT conjugate vaccine as compared to Mencevax ACWY~     when given to healthy subjects 11 to 55 years of age. In addition, the safety and~     immunogenicity of a booster dose of MenACWY-TT vaccine administered to all eligible subjects~     10 years after the primary vaccination will be evaluated.~      All Filipino subjects who received the primary vaccination in the primary vaccination study~     107386 (NCT00356369) will be invited to enrol in the long-term follow up and booster phase.~     No new subjects will be enrolled.~   "
124676|NCT01935531|"~     The rationale of this study is to investigate the effects of topical diclofenac on tumor~     metabolism in the treatment of actinic keratoses in immunocompetent and immunocompromised~     patients.~      Study hypothesis is that topical diclofenac lowers lactate level in skin biopsies of actinic~     keratoses. Planned number of patients is 38.~      This study is a monocenter study investigating the effects of 3% diclofenac in 2.5%~     hyaluronic acid gel on tumor metabolism in the treatment of actinic keratoses. Treatment~     duration is 3 months. Skin biopsies will be obtained before treatment, at the end of the~     treatment and four weeks after the treatment. Control biopsies at visit 1 and 3 are performed~     in healthy, sun damaged and untreated skin. Evaluation of efficacy will be performed at the~     end of the treatment and four weeks after the treatment.~      Duration of treatment is 3 months (±4 weeks). Approximately 0,5g Solaraze® 3% gel is applied~     on a 5cm x 5cm lesion. Solaraze® 3% gel is applied twice daily on the study lesions.~   "
124677|NCT01935518|"~     This study will examine whether fasudil is effective and safe in treating patients with~     amyotrophic lateral sclerosis (ALS).~   "
124678|NCT01935505|"~     This is a observation non-randomized control trial, and a follow-up study on the smoking~     cessation.~   "
124679|NCT01935492|"~     An open randomized phase III study to compare 8 continuous cycles of chemotherapy with 8~     cycles of intermittent (2 times 4 cycles) chemotherapy in first line treatment, in~     combination with bevacizumab, and second line treatment of patients with HER2/neu negative,~     incurable, metastatic or unresectable locally advanced breast cancer.~   "
124680|NCT01935479|"~     The objective of this study is to investigate the pharmacokinetics, safety, and tolerability~     of AK159 administered to healthy postmenopausal women.~   "
124681|NCT01935466|"~     Pioglitazone, an agonist of the peroxisome-proliferator-activated receptor (PPAR), is a~     relatively new oral anti-hyperglycemic drug. Since its first approval in the USA in 1999, a~     potential link with bladder cancer has been a subject of debate. US Food and Drug~     Administration (FDA) in September, 2010 and European Medicines Agency in July, 2011 issued an~     alert about a potential relation between the occurrence of bladder cancer and the~     prescription of pioglitazone, based on the data from various studies. France banned its use~     in July 2011.~      Recently Pioglitazone was banned from India without any evidence of increased bladder cancer~     in our population. With this background, we plan to study the risk of bladder cancer in male~     type 2 diabetes subjects aged more than 50 years who are on pioglitazone therapy as compared~     to never-users of pioglitazone in a retrospective cohort design and provide the first data~     from India to the policy makers regarding the purported risk in our ethnicity and~     geographical area.~   "
124682|NCT01935453|"~     The main purpose of this study is to study the safety of OrienX010 in the treatment of kinds~     of solid tumors such as melanoma,liver cancer,pancreatic cancer and lung cancer.~   "
124683|NCT01935440|"~     The goal of this study is to conduct an HIV prevention intervention to train HIV seropositive~     drug users to be peer health educators.~   "
124684|NCT01935427|"~     This study is designed to validate implementation of the CRI algorithm in the CypherOx CRI~     system.~      Healthy human subjects will undergo progressive reduction in central blood volume to the~     point of hemodynamic instability (defined by a precipitous fall in systolic blood pressure~     (SBP) below 70 mmHg and/or voluntary subject termination due to discomfort (such as sweating,~     nausea, or dizziness) to validate the following hypotheses:~      The CypherOx CRI system will A. Trend intravascular volume changes (hemorrhage) B. Trend~     stroke volume changes and C. The CRI trend value is not relative to an initial CRI reading,~     instead it is an actual CRI trend value that does not require calibration or being placed~     during normal physiological conditions.~   "
124685|NCT01935414|"~     This study hypothesises that the geko™ device is more efficient than TEDS in preventing the~     formation of symptomatic/asymptomatic Deep Vein Thrombosis (DVTs), post-surgery.~   "
124686|NCT01935401|"~     The purpose of this study will be to replicate previous findings of deficits in prefrontal~     activation during response inhibition tasks in bulimia nervosa and extend these findings by~     demonstrating similar deficiencies in activity during a functional behavioral task that~     requires the inhibition of eating. Findings from this study will potentially help to~     elucidate the underlying neural mechanisms of bulimia nervosa, and thus inform treatment and~     prevention efforts.~   "
124687|NCT01935388|"~     Many hospitals employ a common canister inhaler protocol in patients that do not require~     mechanical ventilator support. Common canister refers to a single inhaler paired with~     standardized cleaning methods for use on more than one patient. Small reports suggest that~     this method does not pose an increased infectious risk and is associated with significant~     cost savings.~      Common canister protocols offer a solution to the discordance between inhaler sizes and~     average inpatient use of the drugs. Metered dose inhaler canisters are contain enough drug~     for several days to weeks of daily use. However, the average length of stay for most~     inpatients is only several days. Therefore, most inpatients do not use all of the canister~     contents, an unused resource that is potentially wasted.~      The common canister approach has not been previously described in mechanically ventilated~     patients (people requiring intensive care unit admission on breathing machines). This study~     aims to assess the safety of common canister utilization by assessment and comparison of~     infection rates in the study and control group.~   "
124688|NCT01935375|"~     HYPOTHESES:~      The hypotheses are that:~        1. nurse midwives will be able to safely deliver interpersonal psychotherapy by telephone~          to women with postpartum depression~        2. women receiving interpersonal psychotherapy will have less symptoms of postpartum~          depression, better functioning, better bonding with their babies, and better~          relationships with their partners~        3. women with postpartum depression will be more satisfied with their care than women in~          the group that was referred to a mental health center.~   "
124783|NCT01934127|"~     The purpose of this study is to evaluate the safety and immunogenicity of different~     formulations of GSK Biologicals H7N1 influenza vaccine in subjects 21 to 64 years of age. The~     study will evaluate safety related events and antibody immune responses to different~     formulations of study vaccine and placebo.~   "
124837|NCT01933425|"~     To investigate if deep neuromuscular blockade improves intraabdominal volume compared to no~     neuromuscular blockade in patients scheduled for gynecologic laparoscopic surgery with~     pneumoperitoneum 12 mmHg.~      Hypothesis:~      Deep neuromuscular blockade improves intraabdominal space (the distance from promontorium to~     skin surface, cm) compared to no neuromuscular blockade.~   "
124689|NCT01935362|"~     Cardiovascular disease (CVD) is the leading cause of deaths in the Western world. Established~     risk factors include high LDL cholesterol, high blood pressure and diabetes. Poor blood~     vessel health is considered a predictor of future CVD risk, but can be reversed. Several~     different measurements can be used to determine blood vessel health; such as blood pressure~     (BP), and newer techniques which measure blood flow through the arteries after a blood~     pressure cuff restricts blood flow for a few minutes in one arm.~      Flavonoids are compounds found in plant-based foods, and are associated with a reduced risk~     of CVD. From the previous studies, there is strong evidence that orange juice and citrus~     foods which have higher amount of specific citrus flavonoids improved cardiovascular risk~     factors such as BP and blood vessel health. Absorption of citrus flavonoids occurs in the~     colon after bacteria breakdown the forms found in food. After the flavonoids are absorbed~     into the blood they are modification by liver enzymes before they are excreted in the urine.~     A large range of citrus flavonoid have been found excreted in the urinary, ranging anywhere~     from 0-57% of the dose. Variation in the potential health effect may reflect the level of the~     citrus flavonoid absorbed, and this is not often considered in human studies.~      This study is a 4-week double-blinded, randomized, cross-over intervention trial using a~     commercially-available orange juice supplement and a placebo control. The aims of the study~     are to determine whether orange juice supplements reduce blood pressure and improve blood~     vessel health after 4 weeks. Furthermore, to determine if there is a relationship between~     absorption of flavonoids (as measured by urinary excretion) and changes in blood pressure or~     blood vessel health.~      The participants will need to attend 4 sessions on 4 separate study days, every 4 weeks for~     12 weeks. On each study day they will have their weight, height, waist circumference, and~     blood pressure measured. A finger-prick blood sample, using a single-use lancet (Accu-Chek~     Safe T Pro Plus), will be taken to check the fasting blood glucose level. Blood flow in~     fingertips will be monitored before and after reducing blood flow in your forearm using a~     blood pressure cuff (called an EndoPAT). Participants will be asked to collect urine for 24~     hr on each of the study days, and to consume the supplements provided daily for two sets of 4~     weeks (there will be 4 weeks in the middle without any supplements).~      An improvement in blood pressure and/or blood flow will provide evidence that blood vessel~     health has improved through short-term (4 week) use of a citrus flavonoid supplement~   "
124690|NCT01935349|"~     Diabetes mellitus (DM) and hypertension (HT) are major causes of morbidity and among the top~     10 causes of deaths in Hong Kong in 2008 (Department of Health 2009). The Hospital Authority~     (HA) has initiated service improvement through introducing the patient empowerment programme~     (PEP) to improve the quality of care (QOC) for DM and HT patients. The evaluation on the QOC~     is an essential part of the programme in order to inform future policy. The Family Medicine~     Unit (FMU) of the University of Hong Kong (HKU) has been appointed by the HA to carry out the~     evaluation of the QOC of the programme.~      The Action Learning and Audit Spiral methodologies to measure whether the target standard of~     care intended by the PEP programme is achieved. Each PEP participating clinic and~     non-government organization (NGO) will be invited to complete a structured evaluation~     questionnaire. The data of all patients who have enrolled into the PEP for more than one year~     will be included in the evaluation on the process and outcomes of care. A hundred and thirty~     participants will be followed up by telephone to evaluate the effect of the programme in~     quality of life (QOL), patient enablement, and global rating of change in health condition at~     baseline and 6 months after enrolment. Data on the process of care will be retrieved from the~     HA medical records. Main Outcome Measures: The primary outcomes are the proportion of~     participants who have received the planned process of care and achieved the target HbA1c and~     blood pressure levels.~      Data Analysis: Descriptive statistics on proportions meeting the QOC criteria will be~     calculated. The changes in clinical, service, and patient reported outcomes at 6 and 12~     months will assessed by paired sample t-test. The audit cycle will be repeated annually over~     a period of 5 years.~      Results: The QOC of the PEP programme will be determined. Areas of deficiency and possible~     areas for quality enhancement will be identified. Conclusion: The results of this study will~     provide empirical evidence on whether the HA's PEP programme can enhance QOC for patients~     with diabetes mellitus (DM) or hypertension (HT). The information will be used to guide~     service planning and policy decision making.~   "
124691|NCT01935336|"~     This phase II trial studies how well ponatinib hydrochloride works in treating patients with~     stage III-IV lung cancer. Ponatinib hydrochloride may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth.~   "
124692|NCT01935323|"~     6-week, single site, two parallel arm, randomized, controlled trial comparing the~     effectiveness of a High Intensity Interval Training (HIIT) versus a continuous Moderate~     Intensity Training (MIT) program on cardiovascular and metabolic health outcomes in~     overweight adolescent males. HIIT training may be a potent time-efficient strategy to induce~     similar metabolic and cardiovascular adaptations typically associated with MIT.~   "
124693|NCT01935310|"~     Recently it was demonstrated that imiquimod in addition to exerting a repairing effect in pre~     malignant and malignant lesions caused by UV radiation it reverses histopathological changes~     associated with the photoaging skin.~      This is an experimental exploratory study. It included 17 patients. The patients were~     diagnosed with photoaging grades III and IV in the scale of Glogau and volunteered to~     participate in the study. Patients were treated with imiquimod 5% topically, for a time~     period of 12 weeks. Biopsies were taken from periorbital skin area at baseline and after 4~     weeks after completing the treatment. Adverse effects, adherence to therapy and patients'~     satisfaction were measured.~      Clinical and histological parameters of photoaging were studied at baseline and after~     treatment. After completion of treatment with imiquimod, the final clinical evaluation was~     compared to the initial one.~   "
124694|NCT01935297|"~     This pilot study will evaluate the effect of a rehabilitative exercise training on exercise~     capacity in patients after percutaneous aortic valve replacement. It will additionally~     evaluate the safety of such an approach and the effect on life quality. We hypothesize that~     regular structured exercise improves exercise capacity in these patients beyond the sole~     effect of the valve procedure.~   "
124695|NCT01935284|"~     To assess the interchangeability and agreement between measurements from three blood gas~     syringes for the collection of blood for the analysis of multiple analytes as measured by~     differing manufacturers' multi-parameter analyzers.~   "
124696|NCT01935271|"~     The ability of older adults to improve their muscle strength through exercise training~     appears related to how well their immune system functions. Thus, a nutritional supplement~     which improves immune function could theoretically boost strength gained for older adults~     from exercise. The purpose of this pilot study is to determine if a nutritional supplement~     has any effect on immune function.~      Veterans (age 60-80 yrs, N=12) be randomized in a double-blind placebo-controlled fashion to~     consume supplement or placebo for four weeks. After two weeks of consumption, subjects will~     be treated with a vaccine for tetanus, diphtheria, and pertussis. Blood will be drawn from~     each subject before and after vaccination to determine the effects of the supplement on~     immune response to vaccination. Additionally, subjects will undergo blood draw and muscle~     biopsy before and after two weeks of supplementation to determine the effects of~     supplementation on other measures of immune function (e.g. cytokine and growth factor~     levels). This is an important issue due to the serious health consequences associated with~     muscle loss in older adults and the need for improved strategies for rehabilitation.~   "
124784|NCT01934114|"~     The purpose of this study is to determine whether an experimental alternative imaging method,~     Near Infrared Spectroscopy (abbreviated as NIR), can be used with a controlled respiratory~     system to examine the breasts for cancer. The NIR system uses light beams to produce an image~     or picture of the inside of the breast. The respiratory system will help researchers get more~     information about the breast tissue by changing the amount of oxygen the tissue receives~     during NIR imaging.~   "
124697|NCT01935258|"~     Medically unexplained symptoms (MUS) are a common and important problem in primary care.~     Patients repeatedly presenting MUS to their general practitioner (GP) suffer from their~     symptoms, are functionally impaired, and are at risk of unnecessary and possibly harmful~     tests, referrals and treatment. Evidence indicate that specific interventions for patients~     with MUS, such as reattribution therapy and cognitive behavioural therapy are of limited~     help. According to experts in this field a multi-component approach is most helpful for these~     patients.~      This pilot trial aims to test the systematic identification of eligible patients, to assess~     the acceptability of the intervention and to estimate potential treatment effects for a~     larger trial.~      It's a randomised pilot study consisting of patients with MUS in primary care. Patients will~     be randomized to intervention (usual care and additional psychosomatic therapy) or control~     condition (usual care alone). Patients will be followed for one year.~      Participants are patients consulting their GP more than once with MUS and in which the GP~     presumes that psychosocial distress is an underlying cause.~      The intervention is the psychosomatic therapy delivered by a psychosomatic therapist,~     consists of a combination of information and education, relaxation therapy and mindfulness,~     cognitive approaches and activating therapy. This multi-component approach is captured into a~     protocol in which therapists are able to modify the treatment in order to deliver a~     tailor-made treatment for patients with MUS.~      Primary outcome measures are: the number of patients identified and recruited, perceived~     symptom severity, measured on a Visual Analogue Scale (VAS) and patients' self-rated symptoms~     of distress, depression, anxiety and somatization (4DSQ: The Four Dimensional Symptom~     Questionnaire). Other primary outcome measures are the time needed to include the eligible~     patients, the number of withdrawals in the intervention and control group, compliance in the~     therapy group and the number of patients who complete the questionnaires.~      Secondary outcome measures are: symptoms of hyperventilation (NHL: Nijmegen Hyperventilation~     List), physical and mental health status and quality of life (SF-36), and level of~     functioning (MAF: measure of general functioning). Patient satisfaction with the received~     therapy is rated on a 5-point Likert-type scale. Medical consumption will be measured by the~     Cost Diary for medical consumption.~   "
124698|NCT01935245|"~     Rationale:~      Cardiac surgery with extracorporeal circulation (ECC) triggers platelets. Minimal~     extracorporeal circulation system (minimal-ECC) has several advantages compared with~     conventional ECC amongst less platelet activation. Platelet function can be analysed with~     thromboelastography (TEG) and multiple electrode aggregometry (MEA).~      Objective:~      The use of minimal ECC leads to less platelet dysfunction compared with conventional ECC in~     coronary artery bypass grafting (CABG) analysed with TEG and MEA~      Study design:~      Single center, prospective, randomized, pilot study~      Study population:~      Group 1:~      20 patients undergoing CABG using minimal ECC. Patients continued the use of acetylsalicylic~     acid and discontinued the use of clopidogrel minimal 5 days preoperative.~      Group 2:~      20 patients undergoing CABG using conventional ECC. Patients continued the use of~     acetylsalicylic acid and discontinued the use of clopidogrel minimal 5 days preoperative.~      Intervention:~      Group 1: CABG using minimal ECC Group 2: CABG using conventional ECC~      Main study parameters/endpoints:~        1. Results of TEG and MEA, see detailed description~        2. Per operative blood loss and total blood loss 24 hours after CABG~        3. Total amount of transfused platelet units during CABG and 24 hours after CABG~   "
124699|NCT01935232|"~     Osteoporosis is a disease that leads to impaired skeletal strength and increased fracture~     risk. Among 200 million osteoporotic patients (Tarantino, Cannata et al. 2007) most are~     diagnosed only after a fracture. We expect with our aging population to see a significant~     increase in the prevalence of osteoporosis. It is estimated that over 75% of osteoporotic~     patients are not diagnosed and do not receive treatment for their condition.~      This research plan describes a study for clinical validation of the novel ultrasound device~     (Bindex®, Bone Index Finland Ltd.). In a preliminary study, the technique has been validated~     in a Finnish postmenopausal woman population of 285 healthy and 56 osteoporotic subjects (n =~     341 in total). Significant and good correlation was observed between Density Index (DI)~     determined with Bindex and femoral neck bone mineral density determined with DXA (r = 0.65 -~     0.70). In addition, with determination of 90% sensitivity and specificity thresholds,~     significant number (65-75%) of patients could be diagnosed without additional verification~     with DXA.~      For validation of the technique in US population, our study plan is presented for~     determination of diagnostic thresholds for osteoporosis. Taken together, DI with Bindex,~     lumbar spine and femoral bone BMD with DXA are obtained from 500 postmenopausal women and 140~     men. The study will be carried out at the HealthEast Osteoporosis Care service in Woodbury,~     MN.~        1. To investigate the capability of DI for prediction of proximal femur and lumbar spine~          BMD;~        2. To develop national diagnostic thresholds for DI in prediction of osteoporosis status~          with a reference population (American-Caucasian) of 500 (if prevalence of osteoporosis~          is 20%) post-menopausal females (50-90 years);~        3. To investigate ability of Density Index + FRAX with BMI in fracture risk prediction;~        4. To investigate correlation between lumbar spine or proximal femur BMD and Density Index~          in 140 men at wide age range (20-90 years), 70 with osteoporosis and 70 with normal or~          low bone mass. Determine diagnostic thresholds for DI in men.~   "
124700|NCT01935219|"~     The objective of this study is to assess the effectiveness of an intervention to address both~     executive function and processing speed changes that contribute to poor driving performance~     in adults with Mild Cognitive Impairment (MCI).~      Our hypotheses are that the study intervention will improve performance on a driving~     simulator and will improve (i) executive function, specifically attention and planning, (ii)~     useful field of view, (iii) mood, (iv) quality of life, and (v) reported motor vehicle~     crashes and driving infractions.~   "
124701|NCT01935206|"~     Recent studies have focused on the role of endogenous opioids on central sensitization.~     Central sensitization is known to be impaired or altered in chronic pain conditions, as~     fibromyalgia or chronic tension headache.~      Animal studies have shown reinstatement of mechanical hypersensitivity following naloxone~     administration after resolution of an injury. This suggests latent sensitization.~      In the present study, investigators hypothesize that naloxone (2 mg/kg) can reinstate~     secondary hyperalgesia 168 hours after a first-degree burn-injury. Investigators aim~     therefore to show that latent sensitization is present in humans and is modulated by~     endogenous opioids.~   "
124702|NCT01935193|"~     The aim of the study is assessing the prevalence of aspirin resistance in a cohort of~     diabetic patients. Those found resistant has been undergone pharmacological tests using~     different drug formulations to investigate the reversibility of aspirin resistance.~   "
124718|NCT01934972|"~     Individuals with bipolar suffer from problems in basic cognitive skills such as memory and~     concentration. Unfortunately, there are no current treatments that have been shown to improve~     cognitive skills among individuals with bipolar disorder.~      Computerized cognitive remediation (CR) is a treatment that has been shown to improve~     cognitive skills among individuals with serious mental illnesses other than bipolar disorder,~     such as schizophrenia. This treatment involves completing a series of activities on a~     computer that have been shown to improve cognitive skills.~      D-cycloserine (DCS) is an antibiotic traditionally used in the treatment of tuberculosis.~     Recent studies have suggested that this drug may also improve individuals' ability to learn.~     Thus, the goal of our study is to examine whether receipt of d-cycloserine increases the~     benefit that individuals receive from participation in cognitive remediation.~      To test this hypothesis, approximately forty subjects will be randomized to one of two study~     arms: [i] CR + DCS or [ii] CR + placebo. We will examine whether d-cycloserine increases the~     benefit that individuals with bipolar disorder receive from participation in cognitive~     remediation.~   "
125330|NCT01926990|"~     This pilot clinical trial studies perfusion computed tomography (CT) in predicting response~     to treatment in patients with advanced kidney cancer. Comparing results of diagnostic~     procedures done before, during, and after targeted therapy may help doctors predict a~     patient's response to treatment and help plan the best treatment.~   "
124703|NCT01935180|"~     Effectiveness of screening colonoscopy in cancer prevention relies on the detection and~     removal of adenomatous polyps. However, a substantial rate of adenomas is missed during a~     colonoscopy. It has been estimated that two thirds of missed adenomas are located on the~     proximal aspect of colonic folds. Attaching a transparent cap to the tip of a colonoscope may~     allow examination of the proximal aspect of colonic folds, and some early studies have~     suggested an increased polyp and adenoma detection using this technology. However, the~     studies have in part substantial methodological limitations (e.g. missing polyp histology,~     single endoscopist study, polyps not removed at the time of detection). Therefore, at this~     point it is unclear whether cap assisted colonoscopy may improve adenoma detection. The~     objective of this study is to evaluate whether cap assisted colonoscopy improves adenoma~     detection.~      The investigators propose a two-center multiple endoscopists randomized controlled trial.~     Patients will be randomized to cap assisted colonoscopy or standard high definition white~     light colonoscopy. The cap is a 4mm commercially available transparent cap that is attached~     to the tip of the colonoscopy. Primary outcome measure is the adenoma detection rate (mean~     number of adenoma per patient). The investigators will assess and adjust for possible~     variables that can affect adenoma detection, including withdrawal time and quality of colon~     preparation. As a secondary outcome of interest the investigators will evaluate a possible~     learning curve effect among all endoscopists (a minimum of six) new to this method. In~     addition the investigators will evaluate whether cap assisted endoscopy improves real time~     prediction of polyp histology.~   "
124704|NCT01935167|"~     Phase 2 clinical study to evaluate of the efficacy and safety of DW1029M on microalbuminuria~     in Patients With Diabetic Nephropathy~   "
124705|NCT01935154|"~     Patients with stage IV or recurrent stage I-III NSCLC with documented disease control~     (objective response or stable disease) within 3 weeks after platinum based 1st line~     chemotherapy; only HLA-A*0201 positive patients with TERT expressing tumors will be included.~      The objective of the trial is survival rate at 12 months.~   "
124706|NCT01935141|"~     With the improvement in CT scanners and injectors, diagnostic chest CT can now be performed~     in less than 10 seconds. It was hypothesized that diagnostic CT pulmonary angiograms could be~     done with less than the usual 80-120 ml of contrast used. We have developed a method of~     performing diagnostic CT pulmonary angiograms with 30 ml of intravenous contrast in most~     patients. The long-term objective of this study is to show that there is no difference in the~     diagnostic efficacy of this low dose 30 ml technique when compared to the more traditional~     full-dose technique.~   "
124707|NCT01935128|"~     The purpose of this study is to evaluate whether conversion to everolimus (Zortress®),~     allowing the elimination or reduction of calcineurin inhibitors, will reduce nephrotoxicity~     (measured by increased creatinine clearance) and lengthen overall graft (kidney transplant)~     survival (measured by 2-3 year graft survival).~   "
124708|NCT01935115|"~     To determine the effect of ketamine, compared to propofol, when used an an anesthetic agent~     for electroconvulsive therapy (ECT) in the treatment of major depressive disorder (MDD). We~     hypothesize that ketamine, compared to propofol, will improve the the symptoms of MDD when~     used as the anesthetic agent to facilitate ECT. Additionally, we hypothesize the dissociative~     and cardiovascular effects of ketamine will be minimal.~   "
124709|NCT01935102|"~     Although many attempts have been done to identify vascular endothelial growth factor-A~     (VEGF-A) single nucleotide polymorphisms (SNPs) correlated with bevacizumab response, in~     advanced cancer patients, the results are still inconclusive.~      We will conduct a pharmacogenetic study to assess, in a population of metastatic breast~     cancer (MBC) patients, the possible predictive role of VEGF-A, VEGF receptor-2 (VEGFR-2),~     interleukin-8 (IL-8), hypoxia inducible factor-1α (HIF-1α), hypoxia inducible factor-2α~     (HIF-2α) and thrombospondin-1 (TSP-1) SNPs for bevacizumab response when combined with~     first-line paclitaxel and for progression free survival (PFS). Analyses will be performed on~     germline DNA obtained from blood samples and SNPs will be investigated by real-time~     polymerase chain reaction (PCR) technique. The multifactor dimensionality reduction (MDR)~     methodology will be applied to investigate the interaction between SNPs.~   "
124710|NCT01935089|"~     We propose to test our primary hypothesis that treatment with Peg-IFN-α-2b will result in a~     decrease in integrated HIV DNA in peripheral blood and tissue in chronically HIV-infected~     immune-reconstituted individuals (see section 3.1) in a prospective, interventional, 1-arm,~     open label clinical trial. To this end, we propose to enroll 25 HIV-1-infected subjects~     (please refer to power calculations in section 10.1 below) currently stably suppressed (> 1y~     with VL < 50 copies/ml) on ART and with CD4 count > 450 cells/µl.~      We hypothesize that 20 weeks of treatment with Peg-IFN-alpha-2b, in the presence of HIV~     reactivation (i.e.: ART interruption), will result in activation of intrinsic and/or~     immune-mediated anti-HIV mechanisms resulting in a decrease in the levels of viral reservoir~     in chronically HIV-infected, immune-reconstituted individuals.~   "
124711|NCT01935076|"~     The purpose of this study is to determine whether placental and umbilical cord blood miRNA~     expression is altered in women with obesity with macrosomic neonates to when compared to~     miRNA expression from control patients.~   "
124719|NCT01934959|"~     Enterocolitis(EC) is the most common and serious postoperative complication of Hirschsprung's~     disease(HD) with high morbidity and mortality. Probiotics are live microbes that, when~     administered in adequate amounts, confer health benefit to the host.Based on this previous~     knowledge on the beneficial effects of probiotics during pro-inflammatory conditions of the~     gastrointestinal tract, investigators hypothesized that oral probiotics could decrease the~     incidence and severity of Hirschsprung's disease associated enterocolitis(HAEC).Investigators~     conducted a prospective, multicenter, randomized and controlled trial to assess whether oral~     probiotics could decrease the incidence and severity of Hirschsprung's disease associated~     enterocolitis(HAEC).~   "
124720|NCT01934946|"~     Purpose: Hip fracture is a common disease on elderly. They become disabled easily if no~     adequate rehabilitation was given. The aim of the study is to compare the effectiveness of~     different types of post acute rehabilitation care for hip fracture.~   "
124785|NCT01934101|"~     Primary Objective:~      • To determine the safety and tolerability of single and multiple ascending oral doses of~     CHR-5154 in healthy volunteers.~      Secondary Objectives:~        -  To determine the pharmacokinetic profile of CHR-5154 and its metabolite CHR-5426.~        -  To compare the pharmacokinetic profile of CHR-5154 and CHR-5426 after a single dose of~          CHR-5154 in the fed and fasted state.~   "
124712|NCT01935063|"~     Chronic pain problems involving the female reproductive system are major health concerns for~     all women. Poorly understood, they entail great personal and financial cost. One such~     condition is vulvodynia, or chronic unexplained vulvar pain, which has a prevalence of 16%.~     Despite its negative impact on psychosexual and relationship satisfaction, there is little~     research examining empirically-tested treatments for afflicted couples. The proposed research~     builds on findings from our work focusing on the impact of relational factors on vulvodynia,~     and our previous research evaluating the efficacy of group cognitive-behavioral therapy for~     this problem. This two-centre randomized clinical trial aims to assess the efficacy of a~     novel, 12-week targeted couple therapy (CBCT) for women with vulvodynia in comparison to one~     of the most commonly prescribed first line medical interventions, topical lidocaine. Primary~     research question: Is there a significant difference between the two treatments on women's~     pain during intercourse post-treatment? Secondary research questions will assess for~     significant differences between the two treatments post-treatment and at 6-month follow-up on~     multidimensional aspects of pain using the McGill Pain Questionnaire, women and partners'~     sexuality (sexual function and satisfaction), psychological adjustment (anxiety, depression,~     catastrophizing, self-efficacy, attributions, and quality of life), relationship factors~     (partner responses, couple satisfaction, attachment, and communication styles), and~     self-reported improvement and treatment satisfaction. Results of this study will improve the~     health and quality of life of patients with vulvodynia by rigorously testing the efficacy of~     a novel couples treatment.~   "
124713|NCT01935050|"~     The purpose of this project is to develop and pilot-test a guided cognitive-behavioral~     self-help program for mild-to-moderate depression in Parkinson's disease (dPD). We will~     pilot-test the guided self-help treatment on 20 people with PD and their caregivers. The~     manual will be revised based on participant feedback. Several feasibility measures regarding~     the guided self-help program (i.e., recruitment, retention, enjoyment, helpfulness,~     adherence) will also be assessed. Moreover, preliminary estimates of effect size for this~     guided self-help program will be calculated and used in future research. We hypothesize that~     people with PD will report decreases in depression, anxiety, and negative thoughts and~     improvements in quality life and sleep and that caregivers will report decreases in burden~     after participating in the guided self-help program~   "
124714|NCT01935024|"~     Exercise has been shown to be beneficial for the brain. The investigators would like to test~     this specifically for those diagnosed with Alzheimer's disease. This study will involve 30~     randomized patients to take part in the out-patient exercise program and 30 patients to~     continue with their regular activities over a 6-month period. Once that period is over, half~     of the 30 patients who participated in the outpatient exercise program will continue in the~     program and the other half will be randomized to independently continue to exercise. The~     investigators hypothesize that exercising will benefit the patient by slowing the dementia~     process, improving behavioral symptoms, and decreasing volume loss of certain brain regions.~     Each person will perform personalized exercise regimens, MR imaging and neuropsychological~     tests will be used to measure the benefits of exercise. Ultimately, the hope is that the~     results of this study could be used to facilitate exercise programs for patients. Enrollment~     is completely voluntary and all personal data obtained will remain confidential.~   "
124715|NCT01935011|"~     The stimulation frequency has been found to affect the axial symptoms of freezing of gait~     (FOG) and speech in advanced Parkinson's disease (PD) patients with subthalamic nucleus deep~     brain stimulation (STN DBS), with the traditionally high stimulation frequency of 130 Hz~     worsening while low frequency of 60 Hz improving these symptoms. The effect of stimulation~     frequency on another important axial symptom, swallowing dysfunction, has not been studied.~     The investigators hypothesize that stimulation frequency could have similar effect on~     swallowing function.~   "
124716|NCT01934998|"~     The spinocerebellar ataxias (SCAs) are a genetically heterogeneous group of dominantly~     inherited progressive ataxia disorders. More than 30 different gene loci have been identified~     so far. The most common SCAs, which together account for more than half of all affected~     families, are SCA1, SCA2, SCA3, and SCA6. Each of these disorders is caused by a translated~     CAG repeat expansion mutation. SCA1, SCA2, and SCA3 usually have an onset between 30 and 40,~     and SCA6 usually begins at the age of 50 to 60. In addition to progressive ataxia, SCA1,~     SCA2, and SCA3 frequently present with additional non-ataxic symptoms, including~     parkinsonism. Carbidopa/levodopa was found to have a good therapeutic effect on parkinsonism.~      The SCA6 used to be considered a pure cerebellar disorder. However, a recent large study on~     natural history of SCAs found that patients with SCA6 often had nonataxia symptoms, an~     observation that challenges the view that SCA6 is a purely cerebellar disorder. Parkinsonism~     in SCA6 was rarely reported, except in a case serial, or a small size study in Korean~     patients.~      Dopamine transporter (DAT) is a very reliable dopaminergic neuronal marker. Reduction in DAT~     density detected by I123 SPECT DaTscanTM in the dopaminergic neuron terminal striatum was~     reported in one small size study consisting of eight SCA6 patients in Korea. There was also a~     PET study using different radioligand for DAT in a small group of SCA6 patients in Germany,~     which found sub-clinical change in DAT density in some patients with SCA6.~      There has been no study so far in the US on parkinsonism and other non-ataxia spectrum and~     striatal dopaminergic damage in SCA6, probably because non-ataxia feature of SCA6 hasn't~     received much attention, and also because DaTscanTM hasn't been clinically available in US~     until recently. The only two published studies on SCA6 and DAT were from Korea and Germany,~     which were of small subject size. There has been no treatment available for SCA6 so far.~      Our hypothesis is that parkinsonism and other non-ataxia spectrum and striatal dopaminergic~     neurodegeneration are part of the SCA6 disease spectrum.~   "
124717|NCT01934985|"~     The investigators propose a 4 year prospective, observational study of 40 patients yearly,~     comparing conventional clinically indicated SPECT and PET perfusion with dynamic rest/stress~     MPI studies with coronary angiography, in some cases performed with quantitative coronary~     anatomy and flow as well as quantitative 13N-ammonia PET MPI. Methods will also be assessed~     for their ability to determine myocardial viability by comparing regional wall motion (WM) on~     clinically indicated serial ventriculography, echocardiography or gated SPECT MPI in those~     protocol patients with WM abnormalities who subsequently undergo revascularization. Patient~     studies will begin in the first study year based on those methods already developed and~     integrate new advances as they become evident.~   "
124750|NCT01934556|"~     The purpose of this research study is to determine if a Treat and Extend regimen~     (increasing the time between visits when the disease is stable and not getting worse) of~     Ranibizumab 0.3 mg injections inside the eye is safe and effective at treating patients with~     swelling of the retina from diabetes.~   "
124797|NCT01933945|"~     This study will collect data of patients who are treated with TACE followed by sorafenib for~     hepatocellular carcinoma (HCC) or patients without Sorafenib after TACE. In contrast to a~     prior observational study on sorafenib (GIDEON study), where pre-treatment with TACE was~     documented retrospectively, this study will collect more detailed information about the TACE~     treatment and the status of a patient when treatment with sorafenib is started.~   "
124721|NCT01934933|"~     This is a prospective, open-label trial to evaluate efficacy for delaying ossification and~     improving inflammation of celebrex treatment on active ankylosing spondylitis (AS). Subjects~     will be randomly divided into three groups (Enbrel group, Celebrex group and Enbrel plus~     Celebrex group) and receive responsable treatment for 54 weeks. Clinical response assessment,~     laboratory assessment and radiology assessment will be recorded. Primary endpoints are the~     magnetic resonance imaging (MRI) Spondyloarthritis Research Consortium of Canada (SPARCC)~     score and the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) of spine and~     sacroiliac(SI) joint, as well as the Assessment of SpondyloArthritis International Society~     (ASAS)20 response rate. Secondary Endpoints include ASAS20, ASAS40, ASAS70 and ASAS5/6~     response rate on each visit and other clinical indexes.~   "
124722|NCT01934920|"~     This trial will assess the incidence of new and/or undiagnosed diabetic macular edema (DME)~     in diabetic patients that undergo a DME screening exam. The screening exam will consist of~     medical history, Electronic ETDRS visual acuity assessment, SD-OCT and color fundus~     photography~   "
124723|NCT01934907|"~     The hypothesis is that transfusion of washed red blood cell can decrease the complication by~     transfusion.~   "
124724|NCT01934894|"~     This phase II trial will combine two agents, cabazitaxel and lapatinib, to treat patients~     with metastatic breast cancer (MBC) which has metastasized to the brain. The first portion of~     the study will determine the optimal dose of the cabazitaxel/lapatinib combination to~     administer to patients. After determining the optimal dose, patients will continue treatment~     with cabazitaxel and lapatinib to assess response to treatment with these agents.~   "
124725|NCT01934881|"~     The programming of subthalamic nucleus (STN) deep brain stimulation (DBS) for Parkinson's~     disease (PD) is complex work because the parameter setting has not been standardized so far.~     The objective of the present study is to set up a standardized programming algorithm for~     Chinese PD patients treated with bilateral STN DBS.~   "
124726|NCT01934868|"~     The hypothesis is that in the treatment of low back pain (LBP) radiating to the leg, the long~     term results of prolotherapy are more effective than those of the current conventional~     treatment: epidural steroid injections (ESI). This research will examine the efficacy of~     prolotherapy injections versus epidural steroid injections for the treatment of low back pain~     radiating to the leg. This is a randomized, unblinded study, in which patients seen in the~     principle investigator's pain clinic will be randomly divided to receive treatments from~     either the experimental, prolotherapy group, or the active control, ESI group.~   "
124727|NCT01934855|"~     The main goal of this research is to characterize patient-specific respiration-induced tumor~     and surrogate motion to evaluate the accuracy and effectiveness of the surrogate-based motion~     management strategies currently used in clinics. Specifically, the investigators hypothesize~     that dynamic MRI (Magnetic Resonance Imaging) obtained over a temporal duration consistent~     with radiotherapy treatments will provide spatio-temporal information of both the tumor and~     surrogate, and therefore can serve as a means to assess the quality of the tumor motion~     tracking with the surrogate. To test this hypothesis, the investigators specifically propose~     to 1) track and characterize the tumor and surrogate motion with 4D (4 dimensional)-MRI and~     2) evaluate surrogate-based motion tracking in a cohort of patients with thoracic tumors.~      External and internal surrogate-based strategies commonly used in clinics have not been~     appropriately validated. With the increasing adaptation of these surrogate methods for motion~     management, the proposed research addresses these urgent issues in clinical radiotherapy~     while providing a means to achieve patient-specific motion management.~   "
124728|NCT01934842|"~     This study will compare blood collection from the forearm using an investigational device,~     TAP20-C to blood collection from the finger tip. The blood collected from the forearm and~     from the fingertip will then be analyzed for glucose, hemoglobin and hemoglobin A1c.~   "
124729|NCT01934829|"~     Although sorafenib is effective and safe in patients with advanced hepatocellular carcinoma~     (HCC), it increases dermatologic toxicities, including hand-foot skin reaction (HFSR), which~     may have a negative impact on patient quality of life (QoL). Urea-based creams may have a~     prophylactic effect on sorafenib-induced HFSR in HCC patients.~   "
124730|NCT01934816|"~     This study aims to examine the involvement of KATP channels on the microvascular actions of~     the incretin GLP-1 and its analogues in healthy individuals and to determine whether the~     acute oral administration of different KATP channel blockers which are oral medications for~     Type 2 diabetes such as Glibenclamide and Glimepiride differentially modulate the~     microvascular responses in these individuals.~   "
124731|NCT01934803|"~     This study is a double-blinded randomized controlled trial (RCT) to assess the efficacy of~     zinc supplementation vs. placebo among 250 HIV-infected Russians from the Russia ARCH Cohort,~     who are ART-naive at enrollment and have a recent history of heavy drinking.~   "
124732|NCT01934790|"~     Eligible subjects must have completed 6 doses of treatment of radium-223 dichloride and~     experienced no radium-223 dichloride-related SAEs (serious adverse events) or CTCAE (Common~     Terminology Criteria for Adverse Events) Grade 3 or 4 adverse event during or after the~     initial course of radium-223 dichloride that led to the discontinuation of treatment. 40~     Subjects will be enrolled and will receive up to 6 doses of radium-223 dichloride 50 kBq/kg~     IV every 4 weeks.~      The subject will be evaluated for AEs (adverse events) and laboratory tests at each visit~     every 4 weeks, prior to receiving radium-223 dichloride.~      After the end of treatment visit the subjects will enter the active follow up period. Related~     AEs and SAEs and Lab tests will be evaluated at each visit every 4 weeks for the first 12~     weeks, then every 12 weeks for up to 2 years after the last dose of radium-223 dichloride.~      After the 2 years of active follow-up, subjects will enter the long-term follow-up period and~     will be followed via telephone follow-up at 6-month intervals for late toxicities and~     survival up to 7 years after the last dose of radium-223 dichloride or until death.~      Joint safety reviews will regularly take place to oversee safety of the subjects conducted at~     regular intervals.~      An interim analysis of the safety data will be conducted during the study.~   "
124733|NCT01934777|"~     The purpose of this interventional study is to evaluate the efficacy and tolerability of~     docosahexaenoic acid (DHA), Vitamin E and Choline in children or adolescents with~     well-characterized and liver biopsy confirmed nonalcoholic fatty liver disease (NAFLD).~   "
124811|NCT01933763|"~     Study to assess the safety and tolerability of ascending single-doses of REGN1193 in healthy~     volunteers.~   "
124734|NCT01934764|"~     Working hypothesis and aims: Biotin is conjugated covalently to several proteins and use as a~     co-factor. Conjugation of biotin to non-targeted, unspecific proteins (e.g. immunoglobulins)~     leads to the breakage of the immune tolerance and to the formation of anti-biotin antibodies.~     Anti-biotin antibodies will be found in correlation with the progression and the present of~     autoimmune disease. In this research the correlation between immune response against biotin~     and the formations of autoimmune disease, will be studied:~      A. Assessment of the possibility that biotin elicit immune response involved in the~     developmental stage of the autoimmune disease.~      B. Assessment of the possibility that anti-biotin antibodies indicate the developmental stage~     of the autoimmune disease and therefore can serve as an disease early stage marker.~      Methods: A. Patient recruitment. Gathering participant's medical record and blood samples. B.~     Records of clinical and biochemical measures. C. Serum of all patient will be tested for the~     correlation between biotin level, biotin bound to antibodies and anti-biotin antibodies to~     liver functions tests. D. Controlled test for repeatedly injected mice with biotinilated~     self-antibodies. Level of anti-biotin will be tested and their influence on the mouse. E.~     Determination of the correlation between biotinilated antibodies or anti-biotin antibodies to~     disease eruption or severance and autoimmune disease.~      Expected results :Serum biotin-protein levels and Anti biotin antibodies levels are increased~     in patients with active autoimmune liver diseases.~      Importance: The proof of connection between biotin-carrying immunoglobulins, anti biotin~     antibodies and autoimmune diseases will open new research direction of possible factors that~     cause to autoimmune disease.~      Probable implications to Medicine: Identification of correlations between reaction to biotine~     and autoimmune diseases will enable their usage as biomarkers for autoimmune diseases,~     severity of the disease and personalization of treatment.~   "
124735|NCT01934751|"~     Hypothesis: Patients who are addicted to opioids or alcohol will have reduced substance use,~     health care utilization if they have immediate and convenient access to pharmacotherapy and~     addiction counselling.~      Summary: This randomized trial will compare two different interventions for 124 alcohol and~     opioid-addicted patients admitted to either Women's Own Detox (WOD) at the University Health~     Network or the Withdrawal Management Service (WMS) at Saint Michael's Hospital (SMH. The~     Delayed Intervention group will receive a card with contact information for the St. Michael's~     Hospital and Women's College Hospital addiction medicine services. The Rapid Intervention~     group will be seen by an addiction physician from one of these services, within a day or two~     of their admission to the WOD or the SMH WMS. The addiction physician will prescribe~     buprenorphine or anti-alcohol medications, and the physician, nurse and/or therapist will~     provide ongoing counseling, follow-up and shared care with the family physician. Outcomes~     (measured at 6 and 12 months) include treatment retention, health care utilization and cost,~     medications prescribed, and alcohol and opioid use.~   "
124736|NCT01934738|"~     The purpose of this study is to investigate safety, toleration and time course of plasma~     concentration of multiple oral doses of PF-06273340 for 14 days in healthy subjects of two~     age groups, aged 18-55 years (Group 1) and aged 56-75 years (Group 2)~   "
124737|NCT01934725|"~     BACKGROUND: In industrialized countries a considerable and increasing proportion of strokes~     occur at younger ages. Stroke at young age causes marked disability at worst and thus~     long-standing socioeconomic consequences and exposes survivors for 4-fold risk of premature~     death compared with background population. Up to 50% of young patients with ischemic stroke~     remain without definitive etiology for their disease despite extensive modern diagnostic~     work-up (i.e. cryptogenic stroke). The group of cryptogenic strokes includes those with~     patent foramen ovale (PFO) or other abnormalities in the atrial septum in the heart as the~     only or concomitant finding. Population prevalence of PFO is high, 25%, and the mechanisms~     how PFO would be associated causally with ischemic stroke remain to be clarified. Moreover,~     there are only scarce data on clinical outcome, long-term risk of new vascular events, and~     prevention of such events in these patients.~      DESIGN: Searching for Explanations for Cryptogenic Stroke in the Young: Revealing the~     Etiology, Triggers, and Outcome (SECRETO) is an international prospective multicenter~     case-control study of young adults (age 18-49) presenting with an imaging-positive first-ever~     ischemic stroke of undetermined etiology (aim N=2000). Patients are included after~     standardized diagnostic procedures (brain MRI, imaging of intracranial and extracranial~     vessels, cardiac imaging, and screening for coagulopathies) and age- and sex-matched to~     healthy controls in a 1:1 fashion. Up to 45 study sites worldwide will be needed to recruit~     the planned participant population during a 3-year period. Neurovascular imaging and~     echocardiography studies, and ECGs will be read centrally.~      AIMS: SECRETO involves five principal fields of investigation: (1) Stroke triggers and~     clinical risk factors; (2) Long-term prognosis (new vascular events, functional and~     psychosocial outcomes); (3) Abnormalities of thrombosis and hemostasis; (4) Biomarkers of~     e.g. inflammation, atherogenesis, endothelial function, thrombosis, platelet activation, and~     hemodynamic stress to characterize postulated cryptogenic stroke mechanisms; and (5) genetic~     study, including genome-wide association and candidate gene studies as well as~     next-generation sequencing approach. All analyses consider cardiac functional and interatrial~     structural properties as a possible mediator. Furthermore, SECRETO Family Study (substudy)~     aims at collecting extensive family history of thrombotic events from informative patients~     being screened for SECRETO main study and collect genetic samples from all consenting family~     members for whole-genome sequencing.~      SIGNIFICANCE: SECRETO will provide novel information on clinical and subclinical risk~     factors, both transient and chronic, predisposing to cryptogenic ischemic stroke in young~     adults. This study also reveals long-term prognosis of this understudied patient population~     and may discover new genetic background underlying the disease mechanism and provide~     potential targets for drug development.~   "
124738|NCT01934712|"~     This trial is conducted in Japan. The aim of the trial is to evaluate the pharmacokinetic~     (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the trial~     drug on the body) properties of FIAsp (faster-acting insulin aspart) and the currently~     marketed insulin aspart (NovoRapid®) in Japanese subjects with type 1 diabetes.~   "
124739|NCT01934699|"~     The investigators will compare myocard vitality diagnostics using 2D-Strain echography and~     MRI.~   "
124740|NCT01934686|"~     This study is conducted in Asia. The aim of this non-interventional study is to evaluate the~     current status of diabetes management, control, and complications in diabetic subjects in~     Indonesia.~   "
124741|NCT01934673|"~     This study is conducted in Asia. The aim of this non-interventional study is to evaluate the~     current status of diabetes management, control, and complications in subjects with type 2~     diabetes in Malaysia.~   "
124742|NCT01934660|"~     Background:~      - Cardiometabolic diseases are a combination of medical disorders that, when they occur~     together, increase the risk of heart disease and diabetes. Researchers want to learn if there~     is a relationship between these diseases and inflammation (redness, swelling, and pain).~     Inflammation affects the entire body. Researchers will study this relationship in people with~     heart disease and diabetes, and compare it to healthy people.~      Objectives:~      - To learn if there are links between inflammation and cardiometabolic diseases.~      Eligibility:~        -  Adults 18 years of age or older with heart disease or diabetes.~        -  Healthy volunteers 18 years of age or older.~      Design:~        -  Participants will have up to six study visits. There will be first visit, then an~          optional visit 12 months after the first visit.~        -  At the study visits they will have:~             -  Blood taken with a needle in their arm.~             -  An electrocardiogram. Small patches are stuck to the chest and limbs. A machine~               measures electrical signals of the heart.~             -  Completed a number of questionnaires.~             -  A body scan called an FDG PET/CT. A substance will be injected through a tube in~               their arm. They will lie on a special bed that will move in and out of the PET/CT~               scanner. The PET/CT scanner will take pictures of the body. The scan will last up~               to 30 minutes.~             -  Some participants will have other body scans ( FDG PET/MRI). The procedures are~               similar to the FDG PET/CT scan. These other scans will last about 30 minutes total.~             -  Some participants will also have a CT scan of their heart. A substance will be~               injected through a tube in their arm. They will lie on a table in a large,~               donut-shaped machine. An X-ray tube will move around their body, taking many~               pictures. This procedure can last up to 2 hours.~             -  Some participants will have tests that measures blood pressure and how the blood~               moves through the body.~             -  Some participants will have small samples of skin and fat tissue taken.~   "
124743|NCT01934647|"~     This clinical trial will study the safety, tolerability, and pharmacodynamics of single doses~     of MK-8892 in participants with PAH. The primary objective is to estimate the measured peak~     effect of the highest acutely tolerated (HAT) single oral dose of MK-8892 on pulmonary~     vascular resistance (PVR).~   "
124744|NCT01934634|"~     The goal of this study is to identify the maximum tolerated dose and dose-limiting side~     effects of LCL161 in combination with gemcitabine and nab-paclitaxel and to provide safety~     data in patients with measurable metastatic pancreatic cancer.~   "
124745|NCT01934621|"~     Individuals with cognitive impairments after stroke sustain significant disability in their~     daily tasks, and account for a significant proportion of stroke-related healthcare costs. The~     proposed study examines a novel intervention, strategy training, that shows promise for~     helping individuals with stroke-related cognitive impairments reduce disability in daily~     tasks, which may lead to reductions in healthcare costs. We predict that strategy training~     will result in significantly greater independence 6 months after stroke compared to an~     attention control intervention, and that strategy training may reduce cognitive impairments.~   "
124746|NCT01934608|"~     To determine the effect of synchronizing a patient's prescription refill schedule on~     medication adherence. The targeted population is Humana members who are currently taking 2 or~     more Stars medications (hypertension, hypercholesterolemia, diabetes) and are current~     customers of RightSource. Participants will be randomized to one of two groups. Group one~     will be usual care and group two will be the Rx synchronization group.~   "
124747|NCT01934595|"~     It is well accepted that during critical illness there is an increase in protein breakdown~     and loss of lean body mass. Previous studies have shown that during critical illness muscle~     breakdown increases dramatically. The aim of our study is to test the hypothesis that~     critically ill patients have improved outcomes with higher protein supplementation.~   "
124748|NCT01934582|"~     A sub-study to the TDE-PH-304 protocol to assess the pharmacokinetics of patients~     transitioning from a twice daily dosing regimen of oral treprostinil to a three times daily~     dosing regimen.~   "
124749|NCT01934569|"~     This study will test the potential for PF-05089771 to interact with a cocktail of drugs~   "
124751|NCT01934543|"~     The overaccumulation of apolipoprotein (apo)B-48-containing lipoproteins of intestinal origin~     observed in patients with insulin-resistance is now thought to be attributable to both~     elevated intestinal production and reduced clearance of these lipoproteins. Substantial~     evidence exists indicating that elevated plasma levels of these lipoproteins are associated~     with increased cardiovascular disease (CVD) risk. Therefore, reduction of atherogenic plasma~     TRL levels of intestinal origin appears to be crucial to improve CVD risk associated with~     insulin-resistance. In this regard, there is some evidence that the clinical recommendation~     to replace dietary saturated fatty acids (SFAs) by n-6 polyunsaturated fatty acids (PUFAs)~     reduces CVD risk in the general population. Although the beneficial impact of n-6 PUFAs on~     CVD risk has been related primarily to favorable changes in plasma LDL-cholesterol levels,~     recent data suggest that chronic n-6 PUFA consumption may also exert beneficial effects on~     CVD risk by reducing postprandial lipemia. The impact of substituting SFAs by n-6 PUFAs on~     postprandial lipid response may be of even greater significance in dyslipidemic patients with~     insulin-resistance among whom intestinal triglyceride-rich lipoproteins (TRLs) represent a~     large proportion of the atherogenic lipoproteins. The general objective of the proposed~     research is to investigate how dietary n-6 PUFAs in place of SFAs modify intestinal~     lipoprotein metabolism in men with dyslipidemia associated with insulin-resistance. The~     investigators hypothesize that the intestinal secretion of apoB-48-containing lipoproteins~     will be lower following a diet rich in n-6 PUFAs than after consuming a diet rich in SFAs.~     The investigators also hypothesize that substitution of SFAs by n-6 PUFAs will be associated~     with significant alterations in expression of key genes and proteins involved in intestinal~     lipoprotein metabolism.~   "
124752|NCT01934530|"~     This randomized controlled clinical pilot trial compared the efficacy of two soft tissue~     grafting methods for correcting esthetic discrepancies associated with non-molar implants in~     the maxilla. Specifically, it was explored whether defects treated with connective tissue~     grafts (SCTG) differed in their outcomes from defects treated with acellular dermal matrix~     allografts (ADM).~   "
124753|NCT01934517|"~     The purpose of this study is to evaluate the validity, reliability and reproducibility of~     digital models obtained from iTero® and Lava Digital® in comparison with traditional plaster~     models.~   "
124754|NCT01934504|"~     The goal of the study is to find biological markers (certain proteins or cellular markers~     found in a blood test) that will inform doctors which patients diagnosed with ANCA-associated~     vasculitis (AAV) are most likely to be able to stop their medications suppressing their~     immune systems and remain in remission.~   "
124755|NCT01934491|"~     This study is evaluating the effects of two brain training exercises on: memory, cognitive~     processing and depression symptoms.~   "
124756|NCT01934478|"~     Based on fundamental study （in Vitro and in Vivo, Pro. Jianjian Li）， Her2 expression would be~     changed from negative to positive by cancer irradiation with liner-accelerator at dose 6GY or~     up. The propose of this study is to reveal the irradiation result on Her2 expression in human~     breast cancer.~   "
124757|NCT01934465|"~     Investigators propose to assess, retrospectively and prospectively the safety and~     tolerability profile (number of participants with adverse events) of standard chemotherapy~     and anti-angiogenic agent bevacizumab (Avastin) as first line treatment of patients with~     advanced or metastatic Non Small Cell Lung Cancer.~      All treatment schedules that are going to be assessed are considered by the international~     guidelines as standard therapy for patients with advanced or metastatic Non Small Cell Lung~     Cancer.~   "
124758|NCT01934452|"~     This prospective study will investigate the characteristics of mRCC patients at time of CR in~     comparison with mRCC patients non on CR treated with Sunitinib, in order to provide some~     answers/ refection leads to the following questions :~      Can we identify blood specificity at time of CR vs non on CR? Shall we distinguish CR with~     sunitinib alone from combined CR (sunitinib with local treatment), while in clinical report~     these 2 cohorts present similar time to recurrence (ALBIGES, ASCO 2010)? Can we identify~     potential predictive serum biomarkers of recurrence? (With the aim of isolating blood~     biomarker that can help on treatment discontinuation decision?)~   "
124759|NCT01934439|"~     Subjects will receive 30 treatments with AMES, to the proximal arm which has been affected by~     a chronic stroke.~   "
124760|NCT01934426|"~     Objective: The study aim to establish high risk admission model and readmission model for~     elderly in Taiwan.~      Method: Investigators compare the clinical, epidemiological, and socioeconomic~     characteristics of admitted patients during 1 August,2011 to 31 July,2012. All patients will~     follow up to end of study to identify 14 days readmission and 30 days readmission to geriatic~     ward.~      Expected Outcomes: (1) To compare the prediction value of derivation cohort and validation~     cohort. (2) To identify high risk indicators of admission and readmission for elderly. (3) To~     determine the risk factors in admission elderly association with quality indicators.~   "
124761|NCT01934413|"~     The purpose of this pilot study is to develop and test a technology-enhanced transitional~     palliative care (TPC) intervention for patients and caregivers living in rural locations. The~     investigators hypothesize that access to palliative care will be improved, thereby improving~     patient and caregiver reported outcomes and decreasing the use of costly health services.~   "
124762|NCT01934400|"~     Objective: The study is to increasing osteoporosis awareness with fracture risk assessments~     and management as well as fall prevention among elderly in northern region of Taiwan.~      Method: Six community osteoporosis and fall prevention educational programme will be held at~     northern region of Taiwan. A questionnaires design including demographic variables , FRAX~     variables, nutritional variables and osteoporosis and fall knowledge variables as well.The~     pretest-posttest method was used to analyse the effect on education.~      Expected outcomes : (1)Fall prevention educational programme will hold in northern region of~     Taiwan at different communities in order to increasing osteoporosis awareness with fracture~     risk assessment tool, establishing fall knowledges among elderly and some fall prevention~     skills.(2)Elderly with 10-year probability of major osteoporotic fracture risk who more than~     20% and 10-year probability of hip fracture risk who more than 3% will identify as high risk~     of osteoporosis. (3) To estimate number of cases who identified as high risk will recommend~     for BMD measurement.~   "
124771|NCT01934283|"~     Small bowel obstruction (SBO) is a common surgical diagnosis. Most of SBO are related to post~     operative adhesions and most of them resolve without the need of surgical intervention. The~     most important thing dealing with SBO is to identify the more complex obstructions that need~     surgery.~      Some clinical, physiological and radiological signs are recognized as markers of a more~     complex obstruction.~      The pathophysiology of bowel obstruction is explained as damage created by pressure on the~     abdominal wall causing ischemia. Yet there are no studies, as far as we know, that measure~     intra-abdominal pressure in SBO patients and it relation to the severity of the obstruction.~      In this study we will measure the intra-abdominal pressure in SBO patients systematically and~     we will examine if more severe obstructions are accompanied by elevated intra-abdominal~     pressure.~   "
124763|NCT01934387|"~     BACKGROUND: The World Health Organization Fracture Risk Assessment Tool (WHO FRAX®) Taiwanese~     calculator is freely available on line to help osteoporosis management. However, its clinical~     utility for improving osteoporosis awareness and patient acceptance has not been validated in~     Taiwanese population.~      OBJECTIVES: This 11-month FRAX® based screening and referral program enrolling older adults~     participating in the geriatric health examinations (GHEs) at the National Taiwan University~     Hospital (NTUH) aiming at determine the patient acceptance of the tool and the program and to~     improve patient awareness in osteoporosis. The second aim is to look for the recommendations~     from the participating physicians to improve the FRAX® -based osteoporosis management model.~      METHODS: The NTUH GHE program is a two stage process to serve 3,000 older adults collecting~     annually from Mar. to Dec. Subjects will be enrolled to the current study at the stage 1 GHE~     visits after informed consent. Baseline questionnaires including the FRAX® tools will be~     distributed and expected to be returned at the stage 2 visits. Research assistants will~     calculate the 10-year predicted fracture risks for the participants during the waiting~     periods and present the numbers to the GHE physicians. High risks individuals will be~     referred to general geriatric clinic for further managements. All participants will be~     provided with osteoporosis and fracture educational material. Patient acceptance and~     awareness will be assessed. The study is to be started from Feb., to Oct., 2013 to enroll~     roughly 1,800 older adults assuming refusal rate about 40%.~      Qualitative interviews will be used to obtain recommendations from study geriatricians in~     Jul., 2013 to optimize the FRAX® based screening and management model.~   "
124764|NCT01934374|"~     Task-oriented exercises combined with strengthening have been shown effective in improving~     walking functions in patients with chronic stroke. However, similar approaches of therapeutic~     exercises have not been applied to subacute stroke with long-term follow-up, using outcome~     measures across the three levels of functioning (body functions/structure, activities, and~     participation) of the International Classification of Functioning, Disability, and~      Health (ICF) model. Therefore, this study will be conducted to fulfill three purposes:~        1. To investigate the long-term effects of a four-week task-oriented lower extremity~          strengthening training (TOLEST) program in patients with subacute stroke;~        2. To investigate the interrelationships among functional connectivity of the brain, lower~          extremity motor functions, physical activity level, and quality of life in patients with~          stroke who have received this four-week TOLEST program in the subacute phase of stroke;~          and~        3. To identify prognostic factors for recovery in functional connectivity of the brain,~          lower extremity motor functions, physical activity level, and quality of life in~          patients with stroke who have received this four-week TOLEST program in the subacute~          phase of stroke.~   "
124765|NCT01934361|"~     This is a multi-center, phase Ib/ II study (two parts) with patients that had recurrent~     glioblastoma multiforme. The first part (phase Ib) was to investigate the maximum tolerated~     dose/Recommended phase ll dose (MTD/RP2D) of once daily buparlisib in combination with~     every-three-week carboplatin or buparlisib once daily in combination with every-six-week~     lomustine (CCNU) using a Bayesian model. Once MTD/ RP2D is established in either of the 2~     arms, the corresponding phase II portion of the study was to start. Phase II was to assess~     the treatment effect of buparlisib in combination with carboplatin in terms of Progression~     Free Survival (PFS) and was to compare the treatment effect of buparlisib with lomustine~     versus lomustine plus placebo in terms of PFS.~   "
124766|NCT01934348|"~     This study aims to implement and refine research protocols required for a full-scale~     randomized controlled trial of Psychological First Aid (PFA) for adult victims of crime. PFA~     is a promising acute intervention designed to reduce the severity and duration of~     trauma-related distress. Law Enforcement Victim Advocates are being trained to implement PFA~     with adult crime victims. A pilot trial is comparing PFA to usual victim advocacy services on~     key psychiatric outcomes from baseline through 4 months post-baseline.~   "
124767|NCT01934335|"~     The purpose of this research study is to test whether vandetanib has an effect on tumor~     growth markers. Vandetanib is not approved by the FDA for use in treating breast cancer. This~     study will compare vandetanib to a placebo.~      The proposed study is designed to determine the change in Ki-67 expression on paired breast~     cancer samples obtained before and after treatment with vandetanib. Other tumor markers~     including RET, TUNEL and phosphorylation specific levels of ERK1/2, AKT and mTOR will also be~     assessed on the paired samples.~      Subjects who have a core biopsy of the breast which demonstrates invasive breast cancer and~     requires surgical excision of the lesion will be eligible for inclusion in the study. The~     tyrosine kinase inhibitor, vandetanib 300 mg, will be given once a day for 7-14 days prior to~     surgery. Following surgery, tissue markers would be analyzed on each of the paired samples,~     allowing for rapid assessment of in vivo response to TKI treatment.~   "
124768|NCT01934322|"~     The purpose of this study is to evaluate a specific case management intervention for frequent~     users (FU) of Emergency Department (ED).~      Compared to infrequent or non-users, most of the ED-FU visitors are identified as vulnerable~     patients because they are more likely to be of low social and economical status, be more~     isolated and live alone. They report more chronic medical conditions, have a higher mortality~     rate and consume more healthcare resources.~      In the literature, interventions aimed at improving the management of ED-FU have demonstrated~     several positive outcomes, but there are still some knowledge gaps.~      The proposed project tests the hypotheses that case management intervention as compared with~     standard emergency care~        -  is a more efficient use of healthcare resources and reduces ED attendance,~        -  is cost-saving and~        -  improves quality of life,~        -  altogether leading to favorable cost-utility ratio.~   "
124769|NCT01934309|"~     The purpose of this study is to evaluate the impact of implementing a clinical decision~     support reminder system for medical providers (i.e., nurses, clinical officers, medical~     officers, consultants) to improve tuberculosis case-ﬁnding and the use of isoniazid~     preventative therapy for adults living with HIV in western Kenya.~   "
124770|NCT01934296|"~     The purpose of this study is to use an investigational device to record brain activity for~     12-24 months following surgical implantation of deep brain stimulation (DBS) systems. The~     goal of the study is better understanding of brain activity in movement disorders and how~     they relate to DBS, not to bring new devices to market.~   "
124812|NCT01933750|"~     Study to determine the effectiveness of the PresVIEW Scleral Implant to improve near vision~     in patients who require reading glasses~   "
124772|NCT01934270|"~     Proper growth in children is a complex process regulated by a combination of genetic,~     nutritional, environmental, hormonal, and others. Growth hormone (GH) is the main hormone~     regulating the growth from childhood to adulthood. Despite great progress in the field, with~     the development of recombinant GH for the treatment of growth hormone deficiency (GHD), there~     is still no reliable method for testing GHD. Physical exertion is one of the significant~     physiologic stimuli for GH secretion, and it is reliable test for identification of GHD. It~     is not in use in the clinics because of its complexity. Recently GH secretion following short~     anaerobic exercise in young adults was tested and also demonstrated significant growth~     hormone secretion~      In contrast to adult children's exercise is characterized by an anaerobic nature. There is no~     data about secretion of growth hormone in response to anaerobic exercise in children.~      Purpose of the experiment:~      The purpose of this study is to evaluate the secretion of growth hormone in response to~     anaerobic exercise in children.~   "
124773|NCT01934257|"~     This clinical trial will determine if the formula given to infants experiencing fussiness,~     crying, cramping, gas, and/or diarrhea, is accepted and well tolerated and helps to resolve~     symptoms.~   "
124774|NCT01934244|"~     This post approval, observational study is being conducted to further evaluate the safety of~     the NovaSure Endometrial Ablation System when it is performed in the presence of Essure~     micro-inserts.~   "
124775|NCT01934231|"~     Acute Bacterial Rhinosinusitis (ABRS) is a respiratory inflammation commonly seen in clinical~     practice, which has with respiratory symptoms including nasal congestion, rhinorrhoea,~     postnasal discharge and cough and is associated with headache, cheek pain, facial pressure~     and other conditions. The principal bacterial pathogens in causing ABRS include Streptococcus~     pneumoniae, Haemophilus influenzae and Moraxella (Branhamella) catarrhalis. These three~     bacteria account for approximately 90% of ABRS in children less than or equal to 5 years of~     age. Combination of Potassium Clavulanate (CVA) and Amoxicillin (AMPC) produces higher~     antibiotic activity against beta-lactamase-producing bacteria. The present study is designed~     to assess the clinical efficacy, bacteriological efficacy and safety of CVA/AMPC (1:14)~     administered in children aged from 3 months to less than 15 years with ABRS. It is an~     open-label study consisting of a 7-day treatment phase and a post-treatment follow-up phase~     for 7 to 14 days.~   "
124776|NCT01934218|"~     The purpose of this study is to determine whether Gel-One demonstrates a superior~     effectiveness in osteoarthritis (OA) knee pain compared with phosphate buffered saline (PBS)~     injections.~   "
124777|NCT01934205|"~     Antimicrobial penetration can be assessed through evaluation of antimicrobial concentrations~     in various lung compartments, including bronchial mucosal tissue, epithelial lining fluid~     (ELF), and alveolar macrophages (AM). Antimicrobial concentrations determined in ELF and~     alveolar macrophages represent an ideal estimate of concentrations at the site of infection~     and can be accessed via bronchoalveolar lavage (BAL). However sampling of antimicrobial~     concentrations via BAL is not routine in clinical practice due to its complex methodology and~     poor patient tolerability. This study will evaluate intrapulmonary and plasma~     pharmacokinetics of GSK2140944 after single IV dose in adult healthy volunteers. This is a~     Phase I, open-label study to evaluate plasma and pulmonary pharmacokinetics following~     intravenous administration of GSK2140944 in healthy adult participants. Part A will evaluate~     the single dose PK profiles. Part B is optional and will only be conducted if necessary. Each~     part will consist of a maximum of 6 cohorts. In Part A, only 4 of the 6 cohorts will be dosed~     initially; cohorts 5 and 6 are optional and will only be dosed if additional time-points are~     necessary to adequately model the pulmonary pharmacokinetic profile.~   "
124778|NCT01934192|"~     This is a multi-center, parallel group, placebo-controlled and active-compared, randomized~     study to assess the ability of GSK962040 to enhance the delivery of enteral feed to~     critically ill subjects that are predisposed to developing feeding intolerance (e.g.,~     percentage of goal volume); enhance gastric emptying in this population; and provide~     preliminary evidence of the drug's effect on outcomes of therapy (length of stay in the~     Intensive Care Unit [ICU], time on ventilator, ICU acquired infections, and 60-day~     mortality). Other aims are evaluation of GSK962040 safety, tolerability and pharmacokinetics~     upon repeat dosing in a critically ill population.~      After meeting eligibility criteria, male and female subjects will be randomized to either~     receive GSK962040 (50 milligram [mg]) once daily (OD) via naso-gastric (NG) or orogastric~     (OG) feeding tube (oral solution), or placebo by the same route. If subjects develop~     intolerance to enteral feeding at any point up to Dose 5 of study medication (inclusive),~     study treatments will switch such that those originally receiving GSK962040 will receive~     metoclopramide (10 mg, intravenous [iv], every 6 hours) and those subjects originally~     randomized to receive placebo will receive GSK962040 (50 mg, via NG, OD). Additionally, if~     subjects develop intolerance prior to any treatment, they will be randomized to receive~     either GSK962040 (50 mg, via NG, OD) or metoclopramide (10 mg, iv, every 6 hours).~      The study will consist of a screening/baseline assessment, a treatment period (up to 7 days~     in duration), and a 4-day post treatment safety follow-up assessment. The duration of each~     subject's participation in the study from screening to follow-up safety assessment will be up~     to approximately 2 weeks. In addition, mortality will be assessed 60 days after admission to~     the ICU.~   "
124779|NCT01934179|"~     This pilot research trial studies telomere length in predicting toxicity in older patients~     with stage III-IV colorectal cancer undergoing chemotherapy. Studying samples of blood from~     patients with cancer in the laboratory may help doctors learn more about changes that occur~     in deoxyribonucleic acid (DNA) and predict how well patients will respond to treatment.~   "
124780|NCT01934166|"~     To investigate if renal impairment will have an impact on the pharmacokinetics of nalmefene~   "
124781|NCT01934153|"~     The purpose of this study is to characterize the pharmacokinetics (PK), safety and~     tolerability of topically applied umeclidinium following single dose topical administration.~     The results from this study will be used to 1) improve our understanding of the risk of~     systemic accumulation upon chronic administration, 2) support dosing recommendations in a~     2a/2b study for axillary administration and, potentially, a separate combined 2a/2b study for~     palmar administration, and 3) confirm whether the same formulation can be used for axillary~     and palmar application for the next studies.~   "
125331|NCT01926977|"~     This study is designed to compare the post injection inflammation and pain seen after~     intravitreal injections of Ranibizumab vs Aflibercept.~   "
124786|NCT01934088|"~     Sedation for endoscopy is a service more than a necessity. Therefore it should be patient~     driven. Patients with inflammatory bowel disease (IBD) undergoes life long endoscopic~     control. Therefore, satisfaction with the procedure experience is paramount for patients with~     IBD. Investigators wish to study the feasibility and the effect on patient experience of two~     drugs. Propofol administered by endoscopy nurses (NAPS) and conventional therapy with a~     combination of fentanyl and midazolam. Investigators hypothesize that patients sedated with~     propofol has a better procedure experience, that a well performed sedation equals a better~     experience and that NAPS is as feasible as fentanyl with midazolam sedation.~   "
124787|NCT01934075|"~     The purpose of this study is to determine whether a mental health intervention for obstetric~     fistula patients in Tanzania improves primary outcomes (depression, PTSD and somatic~     symptoms) and secondary outcomes (coping, perceived stigma, social support, social~     participation, efficacy to engage with providers, adherence to clinical recommendations and~     social reintegration).~   "
124788|NCT01934062|"~     This is a retrospective chart review to assess the incidence and the degree of blood pressure~     changes after induction of anesthesia and to study the effect of different induction agents~     on blood pressure.~   "
124789|NCT01934049|"~     Hip fractures incidence grows rapidly with the aging of the population. After indicated~     surgical treatment, hip fracture patients experience high rates of postoperative~     complications, postoperative delirium (PD), postoperative cognitive dysfunction (POCD),~     leading to poor postoperative recovery during hospitalization, which can cause disability,~     distress for both patients and their families, are associated with other medical~     complications and account for significant additional health care costs. We currently use~     dexmedetomidine in elderly patients with hip fractures undergoing hip hemi-arthroplasty in~     order to improve postoperative recovery and prevent and treating PD and POCD.~      Dexmedetomidine is a drug used for sedation in critically ill patients that provides some~     pain relief and controls the bodies response to stress. The sedation produced by~     dexmedetomidine appears more similar to natural sleep than any other drug used for anesthesia~     and postoperative sedation. Data suggesting that dexmedetomidine can prevent delirium~     following cardiac surgery and the developing understanding of the causes of PD and POCD~     suggest that dexmedetomidine will be particularly effective.~   "
124790|NCT01934036|"~     The aim of the study is to evaluate the effects of a dietary supplement (Obex®) on~     anthropometric and physiological variables in Spanish women between 35 and 60 years who are~     overweight or obese.~   "
124791|NCT01934023|"~     This laboratory pilot study will explore the effects of varenicline tartrate on long-term~     potentiation (LTP)-like mechanisms of (1) the motor cortex and (2) the dorsolateral~     prefrontal cortex (DLPFC) and working memory in non-smoking patients with schizophrenia and~     healthy controls using a Paired Associative Stimulation (PAS) method. The present study will~     use this novel PAS method to evaluate the effects of five doses of varenicline (Champix) 0.5~     mg BID treatment on neuroplasticity changes and working memory in 28 non-smokers with~     schizophrenia and 28 non-smoking controls in a placebo-controlled, double-blinded, cross-over~     design. The hypothesis is that varenicline will increase LTP-like facilitation of the DLPFC~     as compared with placebo in patients with schizophrenia, with less or a null effect in~     healthy controls. Likewise, it is hypothesized that varenicline will specifically improve~     working memory in patients with schizophrenia as compared with placebo and healthy controls.~     We Hypothesize that: 1.Patients with Schizophrenia(SCZ) will have reduced cortical LTP and~     impaired working memory compared to healthy controls 2. Sub-chronic varenicline challenge~     will attenuate the cortical LTP and working memory deficit in patients with SCZ. 3.Reversal~     of the cortical LTP deficit by varenicline in patients with SCZ will be associated with~     improvement in working memory.~   "
124792|NCT01934010|"~     The purpose of this research study is to test the safety and local tolerance of repeated~     treatment cycles of AM-101.~   "
124793|NCT01933997|"~     objective: To assess the safety, tolerability and pharmacokinetics of metadoxine,~     administered as repeated oral doses of MG01CI tablets (2 X 700 mg metadoxine per~     administration), to healthy adult subjects.~      This is a single center, open-label, repeated-dose study in healthy male and female~     volunteers. Subjects will undergo screening within 21 days prior to the first dosing to~     assess their eligibility to participate in the study.~      All subjects will receive 1400 mg metadoxine as two MG01CI oral extended-release tablets,~     administered once daily for five consecutive days.~      Blood samples for metadoxine (which consists of two components: pyrrolidone-5-carboxylate and~     pyridoxine that can be identified in plasma concentration assays) will be drawn at designated~     time points, as described in the pharmacokinetic (PK) evaluation section. The subjects will~     remain confined to the unit for 6 days after first dosing.~      A study termination visit will take place 10-12 days after the last dosing day. The subjects~     will be monitored for safety, and AEs (Adverse events) will be recorded throughout the study.~   "
124794|NCT01933984|"~     This study evaluates whether individualized dosing schedule of inhaled bronchodilator is more~     effective than fixed dosing in reducing airway resistance of intubated COPD patients.~   "
124795|NCT01933971|"~     Study rationale: Bio-ker has developed the new formulation of filgrastim BK0023 with the same~     active content as Neupogen®. BK0023 is expected to have the same tolerability profile and~     clinical effects as Neupogen® in controlling myelo-toxicity induced by chemotherapy given for~     the treatment of solid and haematological tumours. It is worth noting that the production and~     manufacturing procedures allow to have a reduction of drug cost thus it is likely to have~     pharmacoeconomic advantages.~      The study is aimed at investigating the pharmacodynamic equivalence and the pharmacokinetic~     bioequivalence of the new BK0023 injectable formulation of filgrastim 0.3 mg/mL by Bio-Ker~     S.r.l. vs. the comparator (Neupogen® 0.3 mg/mL, Dompé Biotec S.p.A., Italy). Healthy male~     subjects will receive test and reference at the doses of 2.5 and 5 µg/kg/day for 7~     consecutive days and at the dose of 10 µg/kg/day for 5 consecutive days according to a~     randomised cross-over design. Pharmacodynamics, pharmacokinetics and safety of BK0023~     injectable formulation 0.3 mg/mL and of Neupogen® 0.3 mg/mL, administered in 2 consecutive~     periods with a wash-out of at least 28 days elapsing between the last injection of period I~     and the first of period II, are compared.~      Study design: Single and multiple escalating dose, double-blind, randomised, two-way~     cross-over, pharmacodynamic and pharmacokinetic bioequivalence study.~   "
124796|NCT01933958|"~     The objective of this study is to assess safety and effectiveness of Regorafenib using in~     real clinical practice~   "
124798|NCT01933932|"~     The purpose of this study is to assess the efficacy of selumetinib in combination with~     docetaxel (75mg/m2) vs placebo in combination with docetaxel (75mg/m2) in patients with~     locally advance or metastatic NSCLCs that harbor mutations of KRAS. This study will also~     assess the PK, safety, patient reported outcomes (PRO) and tolerability profile of the~     selumetinib/docetaxel combination, compared to placebo in combination with docetaxel~   "
124799|NCT01933919|"~     The objective of the first phase of this study is to evaluate the efficacy of fluvoxamine~     compared to placebo on change in total score of Japanese version of the Children's Yale-Brown~     Obsessive Compulsive Scale (JCY-BOCS) 10-item from baseline to the last observation visit (10~     weeks) in pediatric/adolescent participants with obsessive compulsive disorder (OCD).~      The objective of the second phase of the study is to evaluate the long-term safety and~     efficacy of fluvoxamine in pediatric/adolescent patients with OCD.~   "
124800|NCT01933906|"~     In this phase I pilot study, it is planned to investigate the feasibility and safety of~     adding an interferon therapy to an preexisting imatinib treatment in patients with chronic~     phase chronic myeloid leukaemia. The participating patients have already reached a response~     during their imatinib therapy (CCyR) but have still a detectable disease (no molecular~     response MR 4.5 or better).~   "
124801|NCT01933893|"~     Pipelle was found to increase pregnancy and implantation rates in women undergoing IVF~     treatment in general, and in particular in repeated implantation failure (RIF). However,~     there is virtually no data regarding the optimal timing for the pipelle.~      The current study aims to compare between follicular and luteal pipelle on pregnancy rate in~     RIF patients.~   "
124802|NCT01933880|"~     The purpose of this long term post-marketing study is to evaluate the effectiveness and~     safety of osmotic release oral system methylphenidate hydrochloride (OROS-MPH) in~     participants with Attention Deficit Hyperactivity Disorder (ADHD).~   "
124803|NCT01933867|"~     Water-aided insertion of the colonoscope has been repeatedly proven to beneficial in terms of~     lower discomfort and need for sedation during colonoscopy. Patients with inflammatory bowel~     diseases (IBD) undergo repeated colonoscopy in course of their disease. According to our~     preliminary experience, water immersion could be beneficial while scoping these patients. As~     far as the investigators know, water-aided colonoscopy has never been studied in this~     indication. Results of our trial might support use of water-aided colonoscopy in common~     practice and decrease associated discomfort in IBD patients.~   "
124804|NCT01933854|"~     The investigators aim to study the prevalence of urinary incontinence in women who live in~     the riverside community in the state of Amapa (The Bailique Island) and compare it to the~     prevalence of urinary incontinence in women who live in the urban region -Macapa-the capital~     city of the Amapa State - Brazil.~   "
124805|NCT01933841|"~     Neuromuscular blocking drugs (NMBDs) provide anesthesiologists with powerful intraoperative~     tools, but their use carries the potential risk of serious postoperative complications.~     NMBD-induced muscle weakness that lingers into the postoperative period, known as~     postoperative residual curarization (PORC), is present in as many as 40% of all patients that~     receive neuromuscular blocking agents. The Post Anesthesia Care Unit will be introducing~     monitoring as part of standard of care. This study will collect data about patients who~     receive NMBDs and examine the impact of monitoring on incidences of PORC.~      Our study is designed to test the following hypotheses:~      Hypothesis 1: The initiation of quantitative TOF monitoring as part of the standard PACU~     entry evaluation will change practitioner behavior in a manner that decreases the incidence~     of PORC in surgical patients at VUMC.~      Hypothesis 2: The initiation of the routine TOF monitoring program will decrease the~     incidence of short- and long-term postoperative complications at VUMC.~   "
124806|NCT01933828|"~     In patients with early stage lung cancer surgical lobectomy is the treatment of choice. A~     resection by Video-assisted Thoracic Surgery (VATS) is probably superior to an open procedure~     by thoracotomy for patients with early stage lung cancer, but randomized evidence for~     superiority is lacking. Furthermore, VATS lobectomy has not gained broad implementation yet.~     The objective of this study is to assess the benefits of VATS- over open lobectomy regarding~     quality of life and costs in a prospective randomized controlled multicenter trial. All~     patients meeting the inclusion criteria that are not randomized will be included in a~     prospective Cohort.~   "
124807|NCT01933815|"~     This trial is divided into two parts, a dose-escalation study (phase 1) and a randomized~     study (phase 2).~      The purpose of the dose-escalation study (phase 1) is to determine the safety, maximum~     tolerated dose (MTD), and efficacy of TPI 287 in combination with Avastin (bevacizumab) in~     subjects who have glioblastoma multiforme (GBM) that has progressed following prior radiation~     therapy and temozolomide (TMZ).~      The purpose of the randomized study (phase 2) is to determine the safety and efficacy of the~     phase 1 MTD of TPI 287 in combination with bevacizumab versus bevacizumab alone in subjects~     who have GBM that has progressed following prior radiation therapy and TMZ.~   "
124808|NCT01933802|"~     The study is an open-label, phase I clinical trial designed to evaluate the safety and~     tolerability of intrathecal administration of autologous mesenchymal stem cell-derived neural~     progenitor cells (MSC-NP) in patients with progressive multiple sclerosis. Study participants~     will receive three intrathecal injections of culture-expanded autologous MSC-NPs at three~     month intervals.~   "
124809|NCT01933789|"~     The purpose of this study is to improve care delivered to patients with serious illness by~     enhancing communication among patients, families, and clinicians in the outpatient setting.~     We are testing a new way to help patients share their preferences for talking about~     end-of-life care with their clinicians and families. To do this we created a simple, short~     feedback form. The form is designed to help clinicians understand what patients would like to~     talk about. The goal of this research study is to show that using a feedback form is possible~     and can be helpful for patients and their families.~   "
124810|NCT01933776|"~     The aim of the study is to assess the safety profile of ADACEL vaccine in a small number of~     participants in China.~      Primary objective:~        -  To describe the safety in terms of occurrence of serious adverse reactions and grade 3~          adverse reactions after administration of Sanofi Pasteur's Tdap vaccine (ADACEL) given~          as a single dose in 20 adults and 20 children.~      Secondary objective:~        -  To describe the full reactogenicity profile after administration of sanofi pasteur's~          Tdap vaccine (ADACEL) given as a single dose in 20 adults and 20 children.~   "
124813|NCT01933737|"~     The elderly population has increased significantly in the last years. The number of falls has~     also increased due to the decrease of balance. The Kinesio Taping (KT) is a method with the~     aim to improve muscle physiology, proprioception, coordination and balance. The aim of the~     study was to investigate the effect of KT on postural balance in the elderly. We evaluated 62~     elderly with a mean age of 67.98±5.321, female, submitted to the protocol for the application~     of KT in gastrocnemius muscles of the midfoot and a placebo tape (3M Micropore) in the~     control group. The application of the tapes was bilateral. Half of the participants (n=31)~     received KT in the lower limbs, while the control group (n=31) was applied placebo tape. To~     analysis of posture and balance, we used a force plate to record stabilometric signals. Both~     groups were evaluated post-application and 48 hours after application of the tape. The~     variables used were total displacement in centimeters (cm), amplitude AP (anterior-posterior)~     and ML (medial-lateral) in centimeters, area (cm²) and speed AP and ML in centimeters for~     seconds. The experimental protocol was performed in standing posture and the subjects were~     instructed to stand with feet apart, eyes open to look at the fixed point 1.5 m from force~     plate in a horizontal direction. It was requested that the elderly maintain the position for~     a time of 40 seconds to collect data The data were collected immediately post application of~     tapes and after 48 hours. The data was tabulated, descriptive statistics were calculated.~     Statistical analysis was performed using the GraphPad Prism 4.0 software (Prism, Chicago,~     IL). The Kolmogorov Smirnov test was used to verify the data distribution. Differences~     between the means were evaluated using the Student T test for the normally distributed data,~     and using the Mann-Whitney test for the data not normally distributed. Significance levels~     were set at p<0.05.~   "
124814|NCT01933724|"~     This is a randomized controlled trial in patients with a diagnosis of granulomatosis with~     polyangiitis (GPA; Wegener's)that are in remission to evaluate the effects of using low-dose~     glucocorticoids ( 5 mg/day of prednisone) as compared to stopping glucocorticoid treatment~     entirely (0 mg/day of prednisone)on rates of disease relapse/disease flares.~      This study is a novel approach to conducting a randomized clinical trial in the community~     setting. This study is being conducted in parallel with a similar study at established~     vasculitis institutions. This study will have a patient centric approach to research in that~     subjects will be recruited online and through social media and vasculitis support networks.~     Participants will be consented online and will receive care through their regular treating~     physician so no travel or additional doctor visits are required. Study participants will~     consent to the study and complete online questionnaires about their prednisone dose and about~     how they are feeling.~   "
124815|NCT01933711|"~     Clinical and pharmacokinetic data suggest that the effect of rituximab could be improved by~     prolonged exposure to the drug. To test for this hypothesis we performed a prospective~     randomized trial of rituximab maintenance therapy versus observation in patients (pts) with~     aggressive CD20+ B-cell lymphoma and mantle cell lymphoma.~   "
124816|NCT01933698|"~     The aim of the present study was to compare the pharmacokinetic profiles and to evaluate the~     bioequivalence of two commercial amoxicillin-suspension formulations in healthy Brazilian~     volunteers.~   "
124817|NCT01933685|"~     The purpose of this study is to define the immune responses induced by a HIV vaccine, AIDSVAX~     B/E. Blood and mucosal samples will be collected to assess immune responses.~   "
124818|NCT01933672|"~     Study B1621019 will assess efficacy and safety of two different dosing regimens of an~     investigational agent (PF-04937319) compared to an approved drug (sitagliptin) in patients~     with type 2 diabetes~   "
124819|NCT01933659|"~     Deep sea water (DSW) is characterized by high purity, low temperature, high nutrients and~     minerals and is obtained from the water flows 200 meters under the surface of the sea. The~     inhibition of H. pylori growth by DSW has been demonstrated in vitro study. However, up to~     now, there is few randomized control study to evaluate the anti-bacterial effects of~     ingesting DSW in patients with H. pylori infection.~      The aims of this study are:~        1. to evaluate the anti-bacterial effects of ingesting DSW in patients with H. pylori~          infection;~        2. to evaluate the patient adherence and adverse effects of ingesting DSW.~   "
124820|NCT01933646|"~     Evaluate the burden of invasive group B streptococcal (GBS) disease in young infants (up to~     90 days of age) in China, in terms of incidence, case fatality rate and serotype distribution~   "
124821|NCT01933633|"~     Overweight/obesity is associated with sub-fertility. The investigators will assess if regular~     exercise training prior to assisted fertilization will improve pregnancy rate in~     overweight/obese women referred to assisted fertilization. It is expected that training will~     be successful in increasing pregnancy rate~   "
124822|NCT01933620|"~     Background:~      - The intestines, mouth, and skin all contain billions of bacteria and some fungi. Every~     person s body contains microorganisms like these. They normally do not make people sick.~     Researchers are interested in how these microorganisms change when a person is hospitalized.~     They want to find out if changes take place because of the hospitalization (such as~     treatments used or changes in medical condition) or because of a person s biology (such as~     their immune system).~      Objectives:~      - To understand which microorganisms are most likely to spread through hospitals and what~     affects that spread.~      Eligibility:~      - People over 2 years of age who are going to be inpatients at the National Institutes of~     Health Clinical Center (NIHCC) for at least 1 week.~      Design:~      - Clinicians will take samples from participants up to once a day for as long as they are~     hospitalized at NIHCC.~      <TAB>- Blood will be taken from a needle in the arm. This will be done only once, unless the~     participant gets a certain infection.~        -  Swabs will be taken with a cotton swab, from the rectal area, groin, throat, and armpit,~          and possibly other areas.~        -  Participants may give a stool sample or be asked to spit into a cup.~        -  Clinicians will collect some information from participants medical records. They may~          request some samples of tissue that are left over from procedures already scheduled at~          NIHCC.~        -  After participants leave the NIHCC, samples may be taken when they return for follow-up~          visits from their hospitalization, for up to 2 years. They will not have to return as a~          follow-up for this study only.~   "
124823|NCT01933607|"~     The study is being conducted to evaluate look the TOPS System when used in patients with~     degenerative spondylolisthesis and lumbar spinal stenosis who would normally be candidates~     for spinal fusion.~   "
124824|NCT01933594|"~     Antiretroviral therapy (ART) can reduce HIV to very low levels in the blood, but it cannot~     cure HIV infection because a small amount of virus remains in cells as a hidden (latent)~     form. The purpose of this study is to evaluate the safety and efficacy of single dose and~     multiple dose administration of romidepsin (RMD) in HIV-infected adults.~   "
124835|NCT01933451|"~     The purpose of this study is to determine whether intraoperative restrictive fluid management~     guided by pulse pressure variation produces a better effect on the postoperative lung~     function, kidney function, inflammatory response and short-term outcome after esophagectomy~     and reconstruction.~   "
124825|NCT01933581|"~     Coronary artery disease and heart attacks are the leading cause of death in the UK. Our~     population is ageing. The number of older patients suffering heart attacks and having~     angioplasty procedures to open up blocked heart arteries is increasing. After angioplasty,~     older patients (80 years of age or over) are at 5 times increased risk of death at one year~     compared to their predicted normal life expectancy. In addition, many patients present with~     further heart attacks, stroke and undergo repeat heart catheter test and angioplasty~     procedures. At present it is not clear who will or will not experience further problems in~     the future. The ability to predict who will and will not suffer future problems at the time~     of initial presentation can be helpful in providing additional treatment and close monitoring~     to those that are at risk of further problems. The ICON 1 study is set out to study just~     that. In this study, older patients will undergo a comprehensive evaluation of the~     cardiovascular disease burden by undergoing additional investigations. These results from~     each patient will be used to develop a risk score that will inform physicians of the~     patient's future risk of developing adverse events and provide a better understanding of how~     to manage older patients with coronary artery disease and also help plan future studies~     looking at treatment strategies that might be beneficial in improving outcomes.~   "
124826|NCT01933568|"~     A phase I trial is being conducted in patients with inoperable locally advanced NSCLC to~     treat with a combination of Conventional Fractionated Radiotherapy (CFRT) on the mediastinal~     lymph nodes and Stereotactic Ablative Radiotherapy (SABR)on the primary tumor with concurrent~     chemotherapy. It is hypothesized that this will lead to an increase of local control and~     overall survival~   "
124827|NCT01933555|"~     Although domestic violence is recognized as major threat in pregnancy, there is no~     intervention has been developed or test to support women in India. To evaluate the effect of~     women's empowerment program administered to abused women in order to reduce domestic abuse,~     improving health status and safety behavior.~   "
124828|NCT01933542|"~     Chlorzoxazone is a centrally acting muscle relaxant used to treat muscle spasm and the~     resulting pain or discomfort. It acts on the spinal cord by depressing reflexes. Our purpose~     is to investigate the effect of chlorzoxazone on moderate to severe postoperative pain after~     spine surgery. Our hypothesis is that chlorzoxazone can reduce postoperative pain and reduce~     opioidconsumption and side effects compared to placebo.~   "
124829|NCT01933529|"~     The purpose of this study is to determine whether a non-hematopoietic erythropoietin~     analogue, ARA 290, exerts beneficial effects on blood glucose levels and insulin secretion in~     persons with prediabetes (impaired glucose tolerance, IGT, or impaired fasting glucose, IFG),~     or drug-naive type 2 diabetes.~      The study will also evaluate effects of ARA 290 on insulin sensitivity and serum levels of~     inflammatory agents, e.g. cytokines. In addition, safety will be monitored by following~     parameters related to hematology, kidney and liver function and lipid levels.~   "
124830|NCT01933516|"~     The purpose of this study is to evaluate safety and pharmacokinetic of GP2013 in Japanese~     patients with CD20 positive low tumor burden indolent B-cell NHL under weekly dosing~     schedule.~   "
124831|NCT01933503|"~     This is a single center, open label, randomized, parallel design, single and multiple dose~     trial to evaluate the pharmacokinetics(PK), safety and tolerability of obeticholic acid~     (OCA).~   "
124832|NCT01933490|"~     Post-gastric bypass hyperinsulinemic hypoglycemia is a recently described disorder occurring~     in some patients after gastric bypass surgery for obesity. The pathogenesis is incompletely~     understood but involves a robust insulin response to ingested carbohydrate. The resultant~     hyperinsulinemia sometimes produces hypoglycemia with neuroglycopenia, confusion and even~     loss of consciousness. Various treatments have been recommended including low carbohydrate~     diets, coingestion of the medication acarbose with carbohydrate containing meals, partial~     pancreatectomy and even total pancreatectomy. None is completely satisfactory. We propose to~     test two new potential treatments. Using a design with random assignment of three conditions~     we plan to compare, in 10 patients with post-gastric bypass hyperinsulinemic hypoglycemia, a~     high carbohydrate test meal (control condition), a high carbohydrate test meal after~     pre-treatment with rapid acting aspart insulin (insulin condition), and a high fructose, low~     glucose test meal with carbohydrate and caloric content similar to the control meal (fructose~     condition).~   "
124833|NCT01933477|"~     The purpose of this study is to understand how to improve health care services for~     HIV-positive women during their pregnancy and after delivery. The study's aim is to compare~     two different ways of providing antiretroviral therapy for pregnant women with HIV. The study~     is to be conducted at the Gugulethu Midwife Obstetric Unit (MOU) in Cape Town. There are~     three phases of the study: Phase 1 is a cross-sectional evaluation of consecutive~     HIV-infected pregnant women attending their first antenatal clinic visit (n=1600); Phase 2 is~     an observational cohort that will follow women from Phase 1 who are eligible for ART (n=600)~     from the second antenatal clinic visit until the first postpartum visit; Phase 3 is a~     randomized trial of women from Phase 2 who are breastfeeding and will compare two different~     service models for delivering ART to women after they delivery their babies (n=480). For~     Phase 3, women who are taking ART will randomly be assigned to either (1) referral to receive~     ART at the nearest adult clinic at 4-8 weeks after delivery (this is currently how all women~     receive care in this setting) or (2) to continue to come to the antenatal clinic for ART~     services until the end of breastfeeding. All women will received the standard local ART~     services (with identical medications and medical treatment); they are different because some~     women will stay longer in care at the antenatal clinic. All women participating in Phase 3~     will be followed through at least 2 months after they deliver.~   "
124834|NCT01933464|"~     This study is designed to investigate whether topical application of a cromolyn sodium~     solution is able to decrease the facial redness seen in patients with papulopustular rosacea.~     Previous work in the lab of Dr. Di Nardo on mice has suggested that cromolyn may be able to~     have this effect. The study will enroll a total of 10 patients. 5 will randomly be assigned~     to receive the cromolyn sodium solution, and the other 5 will be randomly assigned to receive~     the placebo solution. All participants will be instructed to apply their assigned solution~     twice daily to their face. Patients will return to the clinic 3, 6, and 8 weeks after the~     distribution of the solutions to measure the efficacy of their assigned solution.~   "
124836|NCT01933438|"~     This study evaluates the ability of a supination and external rotation protocol to improve~     the arm function and anatomy of children with birth related brachial plexus injuries.~   "
124838|NCT01933412|"~     This is an open label clinical study designed to evaluate the safety and immunogenicity of~     Sci-B-Vac Hepatitis B Vaccine compared to Engerix-B Hepatitis B Vaccine in dialysis patients.~     The study hypothesis is that vaccination with Sci B Vac will achieve a higher seroprotection~     rate and a higher anti-Hepatitis B surface antibody serum titer level than vaccination with~     Engerix-B Dialysis patients will be categorized as naïve or previously vaccinated and~     each group will be randomized to treatment. Naïve patients randomized to Sci-B-Vac Hepatitis~     B vaccine will receive vaccination in three doses, 10 μg each, at 0, 1, and 6 months, or~     Engerix-B Hepatitis B vaccine given in four doses, 40 μg each, at 0, 1, 2, and 6 months.~     Previously vaccinated patients randomized to Sci-B-Vac Hepatitis B vaccine will receive~     vaccination in three doses, 20 μg each, at 0, 1, and 6 months, or Engerix-B Hepatitis B~     vaccine given in four doses, 40 μg each, at 0, 1, 2, and 6 months. All vaccines will be~     administered via intra-muscular injection to the deltoid muscle. The study will consist of~     three periods: a screening period of up to four weeks, a 24-week open-label treatment period,~     and a 24-week safety follow-up period. The total expected duration of the study per subject~     is 52 weeks as follows: Screening period: approximately 4 weeks; treatment period: 24 weeks;~     and follow up period: 24 weeks. The primary endpoint is the by-vaccine difference in the~     proportion of subjects attaining seroprotective immune response (anti-Hepatitis B surface~     antibody ≥ 10 IU/mL) 4 weeks after the last vaccination with either Sci-B-Vac or Engerix-B.~     Secondary endpoints include anti-Hepatitis B surface antibody geometric mean concentrations~     calculated for all subjects upon last active dose; the proportion of subjects with~     anti-Hepatitis B surface antibody concentrations equal to or above 10 IU/mL for all subjects~     at 12 weeks following the first vaccine dose; the by-treatment difference in serum titer~     levels of anti-Hepatitis B surface antibodies at 12, 24 and 52 weeks following the first~     vaccination. A by-vaccine comparison of adverse events will also be performed.~   "
124839|NCT01933399|"~     This study is designed to discern if the use of a lumbosacral orthesis (LSO, also call a back~     support) improves the short-term outcome of lower back pain. participants will receive~     standard care (physical therapy, physician treatment), with one group also receiving an~     extensible LSO, and another group receiving an inextensible LSO. The inextensible LSO has~     been shown to increase stiffness of the trunk in individuals while wearing it. The hypothesis~     is that the group wearing the inextensible LSO will have improved outcomes over the other two~     groups (standard care or standard care plus the extensible LSO).~   "
124840|NCT01933386|"~     The primary objective of this study is to compare the SoundBite™ Hearing System to surgically~     implanted BCD systems.~   "
124841|NCT01933373|"~     Achalasia is a rare motor disorder of the gastroesophageal junction which is associated with~     an increased pressure of the esophageal sphincter. This leads to impairment to swallow and~     heartburn. Esophageal myotomy, which is a surgical longitudinal incision of the esophageal~     muscle layer extending over to the gastroesophageal junction is the treatment of choice for~     achalasia. In order to prevent reflux of stomach content into the esophagus this has to be~     combined with an antireflux procedure where the upper part of the stomach (fundus) is wrapped~     around the esophagus (fundoplication). This procedure can be performed with the wrapped~     fundus either in front of the esophagus (Dor procedure) or behind (Toupet). The latter~     introduces an angulation of the esophagus, which possibly may lead to an impairment of~     swallowing ability and passage of food to the stomach. On the other hand, the Toupet~     procedure may give a better control of reflux. The primary endpoint of the study is symptoms~     of impaired swallowing 1 year after treatment. Secondary outcomes include reflux (pH~     measurements in the esophagus), radiological imaging of swallowing and quality of life.~   "
124842|NCT01933360|"~     Despite of the widespread use, and extensive studies, the optimal route of administration of~     misoprostol before surgical abortion remains to be defined. Following administration of 400~     mcg vaginally as per clinical guidelines, the time for optimal priming seems to be 3 hours,~     but the longer the interval the greater the risk or bleeding and expulsion of the uterine~     contents before the surgical evacuation. Sublingual administration seems to give adequate~     plasma concentration and cervical priming faster than oral or vaginal administration. This~     may allow a shorter waiting time with maintained efficacy, less side effects and logistic~     advantages.~   "
124843|NCT01933347|"~     The purpose of this study is to evaluate the disease control rate (DCR) of gefitinib as~     third-line retreatment in stage IIIB/IV NSCLC with EGFR 19del/L858R positive mutation~     patients who had benefited from first-line gefitinib treatment with EGFR 19del/L858R positive~     mutation and tumor progression after the second-line chemotherapy~   "
124844|NCT01933334|"~     PSSc-001 (LOTUSS)~      This study is a Phase 2, multinational, open-label, randomized, parallel-group, safety and~     tolerability study of pirfenidone in participants with systemic sclerosis−related~     interstitial lung disease (SSc-ILD).~   "
124845|NCT01933321|"~     Autologous cell therapy in patients with ALS can stimulate neuroplasticity, modifying the~     neurodegenerative process and stops the clinical progression of disease.~   "
124846|NCT01933308|"~     Chronic obstructive pulmonary disease (COPD) has a profound impact on the lives of~     individuals who suffer from it. Participants with COPD are often caught in a downward spiral~     that goes from chronic airflow limitation to invalidity and poor quality of life. Exercise~     training is considered the key to successful pulmonary rehabilitation (PR) because it is~     responsible for much of the benefits associated with this intervention. However, despite~     current guidelines recommend high-intensity exercise training. the optimal exercise training~     protocol for PR participants has yet to be determined. Aims: The main goal of the proposed~     research project will be to determine the optimal exercise training protocol in PR. More~     specifically, the objectives will be to compare the effects of continuous high-intensity~     training (CT80), continuous training at the ventilatory threshold (CTVT), and interval~     training (IT) on various PR program outcomes and to compare participant compliance to the~     three training regimens. Methods: One hundred and twenty subjects will be recruited.~     Participants who meet the eligibility criteria and accept to participate in the study will be~     randomized to one of three groups: the CT80 group, the CTVT group, or the IT group. Session~     duration will be adjusted such that the total amount of work performed per session will be~     comparable between the three groups. Assessments will be made at baseline (week 0), at~     program completion (week 12), and one year after program start (year 1). The primary outcome~     measure will be short-term (12 weeks) change in exercise tolerance, as measured by the~     endurance time to constant-load cycling. Secondary outcome measures will include: long-term~     (1 year) change in exercise tolerance; short-term and long-term changes in functional status,~     psychological status, cognition, and health-related quality of life; average participant~     compliance to the target intensity throughout the 12-week program; and long-term adherence to~     exercise recommendations. Relevance: The proposed research will inform clinicians and~     scientists regarding which of the exercise training protocols currently used in PR is optimal~     for COPD participants by examining their short-term and long-term impact on physiological,~     functional, psychological, neuropsychological, behavioural and quality of life outcomes. For~     COPD participants, our findings have the potential to improve the effectiveness of a key~     intervention for the management of their disease.~   "
124847|NCT01933295|"~     Insomnia is recognized as the most prevalent and costly sleep disorders and is associated~     with considerable morbidity including significantly reduced quality of life, impaired work~     performance, and increased risk for major depressive disorder.1-4 Insomnia is a key symptom~     of the menopausal transition. Cognitive-behavioral therapy for insomnia (CBT-I) yields~     equivalent short-term efficacy and superior long-term durability to pharmacological treatment~     of insomnia. The efficacy of cognitive behavioral therapy for insomnia comorbid with~     menopause will be tested.~   "
124848|NCT01933282|"~     Study on the efficacy and safety of MESA chemotherapy for treating NK/T cell lymphoma~   "
124873|NCT01932957|"~     Standard management for patients with ruptured ectopic pregnancies at our institution is~     treatment by laparotomy. This trail will investigate the feasibility of treatment with~     laparoscopy and will look at outcomes such as hospital stay and pain experienced~      The hypothesis is that laparoscopy is a feasible treatment option associated with shorter~     hospital stay and less pain~   "
124849|NCT01933269|"~     The purpose of this study is to assess a relatively new PET (Positron emission tomography)~     radiotracer called FACBC in the assessment of head and neck cancer. FDG (Flourine~     Deoxyglucose) is currently used for PET imaging, but has limitations in head and neck cancer.~     These limitations include problems with specificity, high background uptake from normal~     structures, difficulty delineating intracranial invasion, and the need to wait several weeks~     after chemotherapy and radiation before imaging. As an amino acid radiotracer, rather than a~     glucose radiotracer, FACBC overcomes some of these limitations. FACBC does not yet have FDA~     (Food and Drug Administration) approval, but does show promise in initial work in patients~     with prostate cancer and brain tumors. Dosimetry work on FACBC has been performed at Emory.~      Our study is a pilot study looking at 10 patients with a new diagnosis of biopsy proven~     squamous cell carcinoma of the oral cavity who will be able to go on to definitive surgical~     resection (ie, surgery without preceding chemotherapy or radiation). Patients must have~     pre-surgical imaging, either with a contrast enhanced CT, FDG PET, or MRI. Patients who~     consent to participate will receive one FACBC PET/CT of the neck, which will require a low~     dose transmission CT of the neck, an intravenous injection of the radiotracer, and imaging~     of the neck that will last up to 1 hour. Patients will have to lie still during the imaging~     time. Total participation time including set up should be less than 90 minutes. Imaging~     results will be analyzed and compared with conventional imaging as well as the surgical~     pathology results~   "
124850|NCT01933256|"~     HIP2B is being developed for the treatment of type 1 and type 2 diabetes mellitus.~      The purpose of this study is to investigate the safety and tolerability of repeat doses of~     HIP2B in subjects with type 2 diabetes mellitus. The study will also assess whether islet~     β-cell number and function will increase over time in response to repeat HIP2B injections.~   "
124851|NCT01933243|"~     Adolescents with anorexia nervosa frequently have associated anxiety, and standard~     medications used for anxiety are unhelpful when patients are malnourished. This is a 12 week~     trial examining the safety, tolerability, and effectiveness of fish oil nutritional~     supplements for anxiety in adolescents with anorexia nervosa.~   "
124852|NCT01933230|"~     The purpose of this study is to determine if cooling the neck of patients with ICH decreases~     brain temperature. In addition, the investigators will determine if the device improves the~     delivery of oxygen to the brain. A third goal is to determine if cooling the neck lowers~     intracranial pressure (which is often times high in patients after ICH).~   "
124853|NCT01933217|"~     Traumatic Brain Injury (TBI) - methylphenidate treatment~   "
124854|NCT01933204|"~     The purpose of this study is to determine whether acupuncture is effective for relieving~     perimenopausal symptoms.~   "
124855|NCT01933191|"~     A single bout of physical activity (treadmill)immediately prior to the dental examination~     reduces anxiety in patients with dental phobia.~   "
124856|NCT01933178|"~     Conjunctivochalasis refers to loose redundant, non-edematous inferior conjunctiva that is~     situated between the globe and lower eyelid, and usually it occurs bilaterally. It has been~     reported to cause ocular discomfort, tear instability, alteration of tear spreading and~     subsequently dry eye, which is a common condition that affects vision and quality of life in~     patients. This condition has also been reported to be associated with aging and ocular~     surface inflammation.~      The assessment of conjunctivochalasis was traditionally based on silt lamp examination and~     this may be cumbersome and highly subjective. Only recently, researchers have advocated the~     use of imaging and more objective documentation by anterior segment optical coherence~     tomography (AS-OCT), using Fourier-Domain RTVue-100 OCT. The AS-OCT is an imaging method that~     documents the tear meniscus and prolapse of conjunctiva into the tear meniscus in a safe,~     rapid and non-invasive way. Image analysis on the area of prolapsed conjunctiva can then be~     used to ascertain the severity of conjunctivochalasis. We propose the use of HD-Cirrus AS-OCT~     for the imaging of conjunctivochalasis, since this technique provides more magnified and~     colored digital images, which helps to delineate different tissues and serves as a better~     education tool for patients.~      This current study aims to investigative the inter and intra examiner reproducibility of~     imaging conjunctivochalasis using HD-Cirrus AS-OCT, using patients from the dry eye clinic~     from the Singapore National Eye Centre. These patients will be asked to come to the centre~     for imaging and have three scans of the same eye performed in one session by two trained~     investigators consecutively. The resulting limits of repeatability will be very useful for us~     to follow up patients who undergo surgical or diathermy treatment for conjunctivochalasis,~     and for sample size calculation in the planning of interventional studies.~   "
124857|NCT01933165|"~     Dry eye clinical research is limited to follow up of disease progression. While a large~     catalogue of tests, such as corneal staining grading, tear break up time (TBUT) and~     Schirmer's test, is available, objective assessments demonstrate poor to moderate~     repeatability. Among these assessments, TBUT has the best repeatability while the Schirmer's~     test shows good repeatability for more severe forms of the disease.1 As such, currently, most~     research outcomes are based on subjective patient complaints rather than objective assessment~     of the condition.~      LipiView Ocular Surface Interferometer (LipiView) is a HSA-approved imaging device that has~     the ability to assess optical interference pattern produced by light reflected off the tear~     film in a safe and non-invasive manner.2 Software analysis of the image then measures the~     tear LLT, which is used to objectively quantify the diagnosis of lipid-deficient dry eye.~      This current study aims to investigative the inter and intra-examiner reproducibility of~     measuring tear lipid layer thickness (LLT) with LipiView, which is used in our current~     clinical setting. LipiView has not been evaluated on its reproducibility of measuring tear~     lipid layer thickness. The study will also assess for correlation between the magnitude of~     tear LLT and the inter and intra-examiner reproducibility of LipiView.~      Once this method is found to be repeatable, this can be used in future clinical settings and~     trials as an additional tool to investigate dry eye treatments.~   "
124858|NCT01933152|"~     Retrospective, non-interventional, observational multi-center field study. Patients diagnosed~     with wet Age-related macular degeneration (wAMD) and having started treatment with~     ranibizumab between January 1, 2009 and December 31, 2009 must be consecutively screened and,~     if eligible, enrolled. Patients will be followed up at maximum until December 31, 2011.~     Switch to any other Anti vascular endothelial growth factor (anti VEGF) treatment will be~     documented. For each patient, demographics, medical history, administered treatments, results~     of ocular and visual assessments and other tests (where available) will be documented.~   "
124859|NCT01933139|"~     To determine whether the addition of audio-visual presentations to standard physician~     interaction improves patient comprehension as it relates to the information provided during~     the informed consent process in patients undergoing hysterectomy.~   "
124860|NCT01933126|"~     The study aims to examine the effect of intrauterine injection of HCG on pregnany rate in~     women undergoing IVF treatment.~   "
124861|NCT01933113|"~     The study is a continuation of the clinical pilot study of lateral hypothalamic area (LHA)~     deep brain stimulation (DBS) for severe obesity. Patients who met the enrollment criteria~     underwent stereotactic placement of bilateral hypothalamic chronic stimulating electrodes.~     The current trial will continue to monitor these subjects as well as objectively measure~     metabolic rate (including energy expenditure, respiratory quotient, oxygen consumption, and~     carbon dioxide production).~   "
124862|NCT01933100|"~     This study was conducted to investigate the effects of rice based-meal on functional~     constipation in young Korean women.~   "
124863|NCT01933087|"~     Infections acquired by patients in hospitals are a major cause of illness and death~     worldwide, and particularly so in hospitals with very limited resources. Simple hygiene~     measures, including improved hand hygiene (particularly with increased use of alcohol-based~     hand rub) by healthcare workers (HCWs) in physical contact with patients, are thought to be~     amongst the most effective ways of reducing such infections. However, in most hospitals hand~     hygiene is practiced poorly and improving hand hygiene behavior amongst hospital staff has~     been found to be difficult.~      This study aims to evaluate the impact of a multimodal intervention to improve hand hygiene~     amongst health care workers in accordance with the WHO Guidelines on Hand Hygiene in Health~     Care. The research design is a prospective stepped wedged trial using all in-patient wards in~     a 1,000 bed hospital located in Northeast Thailand (Sappasitthiprasong hospital, Ubon~     Ratchatani). A stepped wedge design is a type of cluster randomized controlled trial which is~     appropriate when there are prior reasons to believe the intervention will be beneficial (as~     opposed to equipoise) and when it is impractical to deliver the intervention to all study~     units simultaneously. Both conditions hold here. The intervention will include educational~     visits to healthcare workers, improved reminders in the workplace, audit and feedback and~     social marketing with the aim of inducing behavioural and cultural change in relation to hand~     hygiene. The intervention will be delivered by the infection control team and the infection~     control ward nurses (ICWNs) who will receive additional training. The primary outcome will be~     directly observed hand hygiene compliance. Secondary outcomes will include incidence density~     of hospital-associated bloodstream and urinary tract infections with specified multiply~     antibiotic resistant bacteria, incidence density of hospital-associated bloodstream and~     urinary tract infections with non-multiply antibiotic resistant bacteria, total patient~     mortality rates, and ward-based consumption of alcohol hand rub and soap (a proxy for hand~     hygiene compliance).~      Results from this study will be immediately generalisable to other resource-constrained~     hospitals in Thailand. The research will also have much wider international significance as~     there have been very few methodologically sound evaluations of the impact of hand hygiene~     interventions in hospitals. Moreover, the findings will provide essential information for~     subsequent work on economic evaluations of infection control interventions to determine under~     what circumstances such interventions are likely to be cost-effective.~   "
124864|NCT01933074|"~     The purpose of this study is to gain a better understanding of what causes urinary urgency in~     women by asking about different symptoms and measuring biomarker levels in their urine.~     Understanding the underlying causes of urinary urgency will allow us to develop treatment~     options to better take care of women with urinary urgency.~   "
124865|NCT01933061|"~     A phase 2, open-label randomized, multicenter trial to compare CC-486 in combination with~     Abraxane administered weekly with respect to overall survival, objective tumor response rate~     and Progression-Free Survival (PFS) in participants diagnosed with metastatic malignant~     melanoma.~   "
124866|NCT01933048|"~     The purpose of this prospective, open-label clinical trial is to evaluate the immunogenicity~     of self-administered (SA) live, attenuated influenza vaccine (LAIV) in comparison with~     healthcare worker administered (HCWA) LAIV and to evaluate the feasibility of group~     self-administration of LAIV.~   "
124867|NCT01933035|"~     To utilise extended platelet parameters in order to individuate Immune Thrombocytopenia (ITP)~     from hypo-proliferative causes of thrombocytopenia.~      To develop the clinical potential of the extended platelet parameters as they pertain to~     distinguishing different causes of thrombocytopenia from one another.~      To test the hypothesis that mean platelet component (MPC) and mean platelet mass (MPM) might~     distinguish between thrombocytopenia related to bone marrow dysfunction and immune mediated~     destruction of platelets.~   "
124868|NCT01933022|"~     The purpose of this study is to investigate the effect of the study medication (Eligard®) on~     cancer markers (in the blood) of prostate cancer.~   "
124869|NCT01933009|"~     GnRH administration during the luteal phase was found to significantly increase pregnancy~     rates in women undergoing fresh-cycle IVF cycles.~      We aim to investigate the effect of GnRH administration during the luteal phase in women~     undergoing frozen-thawed IVF cycles.~   "
124870|NCT01932996|"~     The goal of this research study is to enhance smoking cessation rates for homeless smokers.~     The original study design proposed to test the effects of 1) an Intensive Smoking~     Intervention, and 2) integrating alcohol abuse treatment with smoking cessation We will~     utilize a 3-group randomized design to test study hypotheses. The three study conditions are~     1) Integrated Intensive Smoking plus Alcohol intervention using cognitive behavioral therapy~     (CBT), CBT—(IS+A); 2) Intensive Smoking Intervention using CBT—(IS); or 3) Usual Care (brief~     smoking cessation and brief alcohol counseling both based on the United States Public Health~     Service's Guidelines)—(UC). Due to low enrollment because of the addition of an alcohol use~     screening criteria, the study was changed to a two arm study and the study time frame~     changed. The two study conditions are 1) Integrated Intensive Smoking plus Alcohol~     intervention using cognitive behavioral therapy (CBT), CBT—(IS+A) and 2) Usual Care (brief~     smoking cessation and brief alcohol counseling both based on the United States Public Health~     Service's Guidelines)—(UC). The study length is reduced to 26 weeks from 52 weeks. All~     participants will receive 12-week treatment with nicotine patch plus nicotine gum/lozenge.~     Counseling will follows the protocol used in a recent study of alcohol dependent smokers and~     will include weekly individual sessions for 3 months followed by study data collection visits~     3 months. Both study conditions will have equal number of study contacts. Study staff will~     make retention contacts with participants in the community during weeks that do not have~     study visits scheduled. Primary smoking outcome is cotinine-verified 7-day smoking abstinence~     at week 26 follow-up while secondary outcome is prolonged smoking abstinence at weeks 12, 16,~     and 26. Secondary alcohol outcome will be self-reported continuous alcohol abstinence for 90~     days at week 26. Recruitment and retention will be enhanced by use of gift cards, bus passes,~     other non-monetary incentives, attractive intervention materials, collaboration with homeless~     shelters, and advice from a Community Advisory Board. Participants will be enrolled from~     homeless shelters and facilities in the 7-county greater Minneapolis/St. Paul metro area. Our~     power calculation indicates that a sample size of 215 per study condition is needed to detect~     proposed treatment effects.~   "
124871|NCT01932983|"~     The study examines the clinical application of TOF (train of four test) used by~     anesthesiologists and neurophysiologists during instrumented spine procedures, as well as~     certain associated parameters. 'Train of four' test is a test routinely used during the~     surgery, which is performed by stimulation of peripheral nerve with purpose to determine the~     degree of muscle relaxation by interpretation of muscle response. During spine surgery, it is~     helpful for the surgeon to have a patient's muscles as relaxed as possible with the least~     amount of tone, especially when exposing. Anesthesiologists achieve this level of relaxation~     by giving a neuromuscular blocking agent. If medication given to do this has not fully left~     their system by the time the surgeon needs to start putting in the screws and rods, then the~     intraoperative monitoring can not be adequately performed. If the muscles are too relaxed,~     then free run EMG and screw stimulation, two monitoring methods used, will not be analyzed~     correctly and the surgery may be adversely affected. This study compares the results of the~     'train of four' test performed by neurophysiologists and anesthesiologists. Additionally, it~     looks at the differences, if any, in comparing stimulation of the foot nerve (tibial n.) or~     hand nerve (ulnar n.) Performing the TOF (train of four test) in the lower extremity can be~     relevant for many reasons. Train of four tests can show the presence of four twitches in the~     arms but the legs may not fully recovered from muscle relaxant given by anesthesia. Also,~     train of four test which uses subjective method of interpretation by anesthesiologists may~     present different results compared than objective quantitative method of train of four test~     interpretation. Ultimately, the goal of this study is to show the importance of 'TOF' testing~     in ensuring that any identifiable preventable intraoperative surgical complication is~     appropriately identified.~   "
124872|NCT01932970|"~     This is a multicenter, multiple-dose, single-arm, open-label study to assess the impact on~     serum corrected calcium levels when switching patients from cinacalcet to etelcalcetide (AMG~     416).~   "
124874|NCT01932944|"~     To demonstrate point accuracy of the Abbott Sensor Based Glucose Monitoring System (System)~     interstitial glucose results against venous glucose reference and capillary fingerstick using~     the Consensus Error Grid over the wear duration. During the course of the wear duration, the~     subject is required to be testing fingerstick glucose measurement at least 8 times a day for~     capillary reference glucose measurements and three in-clinic visits of maximum 10 hours each~     for venous reference glucose measurements. With every reference measurement, the subject or~     study staff will perform a measurement on the System.~   "
124875|NCT01932931|"~     In recent years it has become evident that some types of antidepressants are associated both~     with an increased risk of falling and decreased bone mineral density. These factors~     predispose patients for serious fractures such as hip fractures with substantial morbidity~     and mortality. The specific mechanisms involved in this negative impact on bone and postural~     control have not been fully elucidated. It is well known that Vitamin D plays an important~     role for bone health as well as muscle function and thus indirectly postural control.~     Furthermore, vitamin D deficiency has been observed among depressed patients. To our~     knowledge no study has investigated the involvement of Vitamin D in relation to the increased~     risk of fractures associated with antidepressants. Therefore, this project will investigate~     the underlying mechanisms leading to skeletal impairment and musculoskeletal symptoms in~     patients receiving different types of antidepressants. Moreover, the effect of vitamin D~     supplementation will be investigated among patients taking these antidepressants.~      150 subjects will participate in this study: 50 of which is diagnosed with depression and~     receive Citalopram (SSRIs); 50 depressed subjects receiving Mirtazapine(NaSRI); and 50~     controls. Through randomisation half of the subjects in each group will receive daily Vitamin~     D supplementation for a period of one year. Through this period all 150 subjects will be~     followed through different measurements including bone density, muscle function and balance,~     nociception, quality of life and depression severity.~      It is expected that results from this study will provide increasing awareness and knowledge~     of the side effect profile of antidepressants on bone metabolism. This may prompt clinicians~     to screen patients at high risk of drug-induced osteopenia or osteoporosis and accordingly~     provide treatment, which may reduce the incidence of potentially avoidable fractures.~     Moreover, some types of antidepressants may show to produce a minimal or even no effect on~     bone turnover, and should be considered as first line treatment in the group of patients at~     risk of fractures.~   "
124876|NCT01932918|"~     Postoperative pain caused by surgery-associated tissue injury is a major concern for all the~     clinical practitioners. Because it affects multiple systems and induces physiological,~     immunological and psychological changes. Previous literature showed surgical injury induces a~     systemic inflammatory metabolic-endocrine response that is proportional to the severity of~     the surgical stress. In surgeries such as liver transplantation, the patients suffer not only~     from postoperative pain but also an additional oxidative stress caused by ischemia~     reperfusion. Previous report have proved that an adequate postoperative pain control improves~     the recovery and reduces the inflammatory cascade by suppression of physiological and~     psychological stresses. However, the effect of postoperative pain management on ischemia~     reperfusion injury is unclear so far. In this three year study, we plan to continue our~     previous study to test the following two hypothesis: (1) postoperative pain exacerbate remote~     organ injury caused by ischemia reperfusion, (2) the interaction of different antinociceptive~     modalities on ischemia reperfusion injury.~   "
124877|NCT01932905|"~     Pain affects up to 30% of the general population. In particular, neuropathic pain (NeP) is~     caused by lesion or desease affecting peripheral or central somatosensory pathways and~     affects 7% of the adult population. Despite the availability of evidence based~     pharmacological and surgical treatment for NeP, about 50% of patients remais symptomatic~     despite best medical treatment. Some neuropathic pain syndromes are specially refractory. In~     particular, central NeP is caused by disease or lesion to central structures involves in~     somatosensory integration of nociceptive information is non-responsive to drugs usually~     employed in other NeP syndromes. Classical neuromodulatory techniques such as conventional~     repetitive Transcranial Magnetic Stimulation aiming at the motor of prefrontal cortices are~     ineffective to relieve pain in this population. Recently new technology advances have made~     possible non-invasive stimulation of deeper cortical targets. Some of them are activelly~     involved in the integration of the perception of pain, such as the anterior cingulate cortex~     or the posterior insula. The aim this study is to treat 90 patients with central pain (post~     stroke pain, spinal cord lesions after trauma or demyelinizating diseases) under best medical~     pharmacological treatment in three different conditions: AAC (n= 30 with the H-Coil),~     Superior Posterior Insula (SPI) n=30 cooled double cone coil double cool coil, and~     sham(n=30). Each patients will undergo daily stimulation for a week, then weekly stimulations~     for 3 months (total of 17 sessions). The main study outcome is pain relief at the last~     stimulation week (visual-analogic scale). Secondary end-points are changes in the McGill Pain~     Questionnaire, Neuropathic Pain Symptom Inventory, DN4 questionnaire, SF -36, brief pain~     inventory and cognitive assessment including the trail making test A and B, Strrop color~     interference test, and subscalles from the CERAD. All patients will undergo quantitative~     sensory test and measurements of cortical excitability over M1 before and after to treatment.~   "
124878|NCT01932892|"~     This study will quantify motion occurring at the socket interface of transhumeral prosthesis~     users during common tasks. Participants in the study will use a body powered prosthesis with~     a hosmer hook terminal device. A motion analysis system and a novel optical sensor embedded~     into the socket wall will record the amount of movement between the residual limb and socket~     of the prosthesis. Participants will complete range of motion and functional tasks. The range~     of motion tasks include shoulder flexion, abduction and rotation as well as elbow flexion.~     The functional tasks include bilateral lift of weighted basket, unilateral lift of weighted~     handle, box and blocks test, walk and carry a gallon of milk, and folding a towel. It is~     expected that the more weight at the terminal device the more rotation at the interface, as~     well as more slip between residual limb and device. It is also expected that the soft tissues~     of the residual limb can be modeled as a nonlinear spring and the amount of movement at the~     interface can be predicted based off the force in the system.~   "
124879|NCT01932879|"~     Studies in animals have suggested that berry preparations or anthocyanin-rich berry extracts~     can reduce body fatness. Previous studies with tea catechins, which belong to the flavonoid~     class of chemicals as do anthocyanins, suggest that these compounds can alter fat oxidation,~     and this may be the mechanism by which body fatness is influenced by anthocyanin intake.~     Well-controlled studies in humans are lacking.~   "
124880|NCT01932866|"~     The purpose of this randomized, controlled study is to evaluate whether the knowledge of a~     personalized diabetes risk score affects adherence to a 12-week diet and exercise lifestyle~     change program in prediabetic patients. The intervention group will receive diabetes risk~     score results at the beginning of the twelve weeks, and the control group will not receive~     these results. Both groups will review their baseline and 12-week diabetes risk score results~     at the conclusion of the program and will be followed for an additional twelve weeks.~     Attendance rates and changes in weight, BMI, abdominal circumference, blood pressure, HgA1c,~     fasting blood glucose, cholesterol, and diabetes risk score will be compared between the~     groups.~   "
124881|NCT01932853|"~     The aim of this study is to assess whether patients receiving current recommendations of an~     adequate dialysis dose by Kt adjusted for body surface area improved survival at 24 months~     compared to those who do not get it, as well as assess whether patients receiving a dose~     greater obtain more benefit.~   "
124882|NCT01932840|"~     Daily consumption of plant sterols have been demonstrated to lower blood cholesterol. The~     Canadian government has recently allowed plant sterols to be added to certain foods and has~     also approved a disease risk reduction claim to be allowed on products containing plant~     sterols. However, it is unknown how Canadian consumers respond to plant sterol claims.~      The objective of this study was to evaluate the attitudes and understanding of different~     types of plant sterol claims on food labels~   "
124883|NCT01932827|"~     Oat fibre consumption has been shown to lower blood cholesterol, which is advantageous for~     heart health. Oat and fibre claims on food labels should help people find heart healthy food~     choices; however consumer attitudes and understanding of such claims are unknown.~      The objective of this study was to evaluate the attitudes and understanding to different~     types of permitted oat fibre claims.~   "
124884|NCT01932814|"~     The purpose of the present study is to determine whether administration of aminoglycosides in~     septic critically ill patient is a risk factor for acute kidney injury~   "
124885|NCT01932801|"~     The goal of this study is to test the efficacy of extended-release naltrexone and harm~     reduction counseling in reducing alcohol-related harm among homeless people with alcohol~     dependence.~   "
124886|NCT01932788|"~     The purpose of this study is to give all mothers the best chance for a healthy pregnancy~     through vitamin D supplementation. We will study women of diverse racial/ethnic backgrounds~     who will receive either the current vitamin D standard of 400 IU/day (in the prenatal~     vitamin) or 4000 IU/day (dose found in previous pregnancy studies to achieve vitamin D~     sufficiency).~      This research is sponsored by the W.K. Kellogg Foundation and the Medical University of South~     Carolina. The purpose of this study is to examine the effectiveness and infection-fighting~     properties of the body in relationship to vitamin D levels. This study is being done at the~     Medical University of South Carolina (MUSC) clinics, and will involve approximately 450~     volunteers.~   "
124887|NCT01932775|"~     Objective: To investigate the performance (safety) of the GlucoTab system for glycaemic~     management in non-critically ill patients with type 2 diabetes at general wards.~   "
124888|NCT01932762|"~     This is a multi-site, open-label trial evaluating the safety and efficacy of 100 mg of~     grazoprevir (MK-5172) used in combination with or without 50 mg of elbasvir (MK-8742) and/or~     ribavirin (RBV) in treating non-cirrhotic treatment-naïve participants with chronic genotype~     (GT) 2, 4, 5, and 6 hepatitis C infection.~      In Part A there is no randomization or stratification; all GT2 participants will be assigned~     to arm A1. In Part B, all GT2 participants will be assigned to Arm B1 and all participants~     with GT4, GT5 and GT6 will be randomized in a 1:1 ratio to either Arm 3 or Arm 4 with~     stratification by genotype.~   "
124889|NCT01932749|"~     The aim of this study is to investigate the effect of repetitive TMS in reduction of~     depressive symptoms in patients with bipolar disorder. In a randomized, single blind clinical~     trials, 30 patients with bipolar disorder in Atieh Neuroscience center will be assigned to~     receive bilateral TMS and unilateral TMS, daily; for 20 sessions. The depressive and anxiety~     symptoms and quality of life will be assessed before the treatment (pre test) during the~     treatment (10th session), and after the treatment (post test). QEEG apply before and after~     rTMS in all subjects.~   "
124890|NCT01932736|"~     This study is looking at whether functional magnetic resonance imaging (fMRI) can see if and~     when the brain responds to pressure stimulations of the eardrum. The study requires 2 visits,~     1 for screening to determine eligibility and 1 for the fMRI. This study will help to~     understand how the middle ear system is controlled, which may have an impact on how people~     with middle ear disease are treated.~   "
124891|NCT01932723|"~     Menstrual low back pain (LBP) is one of the common complaints among women. Menstrual LBP may~     be attributed to the spinal instability resulting from ligament laxity due to hormonal~     change. The purpose of this study was to investigate the effect of functional lumbar~     stabilization exercises on pain, disability and kinesiophobia in women with menstrual LBP.~   "
124892|NCT01932710|"~     Patients with leukemia often have low white blood cell counts after chemotherapy, which puts~     them at greater risk of infection. The standard of care for preventing infections is to give~     these patients antibiotic, antifungal, and antiviral drugs during the time that white blood~     cell counts are low. However, many patients still develop infections during chemotherapy.~     Radiated white blood cell transfusions are a standard treatment once a patient develops a~     severe infection.~      The goal of this clinical research study is to learn if giving white blood cell transfusions~     that are not radiated early in chemotherapy might delay or prevent infections in patients~     with leukemia. Researchers also want to learn more about the type and severity of any~     infections that do occur.~   "
124893|NCT01932697|"~     This phase II trial studies how well radiation therapy and docetaxel work in treating~     patients with human papillomavirus (HPV)-related oropharyngeal cancer. Radiation therapy uses~     high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, work~     in different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Giving radiation therapy with~     docetaxel my kill more tumor cells.~   "
124894|NCT01932684|"~     Objective: To evaluate the effects of technical-Breath Stacking (BS) and incentive spirometry~     (IS) on the volume of the chest immediately after and within thirty minutes after the~     techniques in patients with Parkinson's disease (PD). Methods: This is a study of cross-over.~     The study investigated 14 patients with mild to moderate PD. The subjects performed the~     technique Breath-Stacking, incentive spirometry volume and participated in a phase control~     according to randomization. The volunteers were evaluated by opto-electronic plethysmography~     in four stages: before, immediately after fifteen and thirty minutes after the completion of~     the techniques. The investigators used a repeated measures ANOVA with post-hoc Tukey test for~     parametric variables, and the Friedman test with post-hoc Dunns for nonparametric variables.~     The level of significance was set at 5%, p <0.05.~   "
124895|NCT01932671|"~     After having had a first cardiovascular event, there is a considerable risk of developing a~     subsequent event. Only recently, a risk prediction model was developed for this group of~     patients. Imaging techniques such as the coronary artery calcium score and contrast-enhanced~     computed tomography (CT) of the coronary and carotid arteries could be able to add improve~     this model. Imaging may further improve the prediction of future manifestations of arterial~     disease and personalize disease monitoring and treatment.~   "
124897|NCT01932645|"~     Prostatitis is so widespread a disease that affects people from youths to seniors, with~     approximately a third experiencing a remission of symptoms over a year follow-up. Although~     the etiology of prostatitis is still not clear, it is mainly thought to be due to infection~     of bacteria or other microorganisms. Up to now, there is still no research being done on the~     microbiome (bacterial species) of the prostate. The objective of this study is to look at the~     etiology of chronic prostatitis(bacteria or non-bacteria prostatitis), mainly focusing on the~     effect of bacteria in the prostate.~   "
124898|NCT01932632|"~     The purpose of this experiment is to test the effect of medication minimization on mortality~     and hospitalization in long-term care residents.~   "
124899|NCT01932619|"~     Breast milk is best food for neonates and preterm infants. However many handling would be~     done if direct breastfeeding is not feasible, and it may result in nutrients change in human~     milk. We investigate the influence of storage in different containers and different thawing~     or heating methods on human milk nutrients.~   "
124900|NCT01932606|"~     Heart failure with preserved ejection fraction (HFpEF) is a major public health problem that~     has no proven effective treatment. This study assessed the effects of acute nitrite~     administration on resting and exercise hemodynamics in patients with HFpEF.~   "
124901|NCT01932593|"~     There is no cure for Multiple Sclerosis (MS) and we are always looking at new ways to stop~     the disease process and/or promote repair.~      We hypothesise that autologous bone marrow cellular therapy in chronic MS offers durable~     benefit.~      The purpose of this study is to test the safety of repeated bone marrow stem cell infusion in~     patients with MS. We want to find out what effects, good and/or bad, it has on you and your~     disability.~      You have previously participated in a safety study of bone marrow stem cell infusion in~     patients with MS. The results raised the possibility of some early partial repair;~     measurements of the speed of neurological impulses in the brain and spinal cord improved. The~     current study seeks to determine whether those benefits have persisted and whether they can~     be repeated or enhanced by repeating the procedure.~   "
124902|NCT01932580|"~     Gastric or gastroesophageal junction adenocarcinoma is commonly treated with chemotherapy~     before and after surgery. The chemotherapy regimen used in our institution, called DCF~     (docetaxel,cisplatic, 5-fluorouracil) is active, resulting in tumor reduction and dysphagia~     relief. however, it is toxic, causing approximately half of patients severe inflammation of~     the mucosa (lining) of the mouth and gut. This results, in turn, in mouth sores, vomiting and~     diarrhea. Similar regimen called FLOT (5-FU, oxaliplatin,docetaxel) appears to be at least~     equally active, but less toxic.~      Our ultimate plan is to perform a randomized comparison of DCF and FLOT. Before embarking~     upon this, we are conducting this pilot trial in 10 subjects with the FLOT regimen. If less~     than 5 patients develop severe mouth sores, vomiting or diarrhea, plans will be made to~     proceed with the next trial, a randomized comparison of DCF and FLOT~   "
124903|NCT01932567|"~     To compare the effect of different airway clearance techniques on lung ventilation by~     electrical impedance tomography.~   "
124904|NCT01932554|"~     The purpose of this study is to determine whether giving abciximab (ReoPro) to children with~     sickle cell disease who are hospitalized for acute pain crisis will improve their pain and~     shorten the time spent in the hospital, when compared with standard supportive care.~   "
124905|NCT01932541|"~     This study is an 8-week open-label trial testing Lurasidone (Latuda®) as a treatment for~     mania in children and adolescents with Bipolar I, Bipolar II, and Bipolar Spectrum disorders.~     We hypothesize that Lurasidone will be safe, tolerable, and effective in improving the core~     symptoms of bipolar disorders in children and adolescents ages 6-17.~   "
124906|NCT01932528|"~     To evaluate the metabolism and routes and extent of elimination of telotristat etiprate and~     its primary metabolite LX1033.~   "
124907|NCT01932515|"~     The trial is in three stages and will translate and validate screening and assessment~     instruments for use with deaf children.~      The first stage is modifying the screening and assessment instruments (ADI-R and ADOS-2) for~     use with deaf children. This will involve choosing the most promising screening instrument~     (SRS-2) based on the systematic review and the expertise of a review panel, which contains~     experts and public and patient involvement (PPI). This phase of the study seeks a wide range~     of user (parents/ carers and young people) views and experiences about the symptomatology and~     presentation of deaf children with autism, comparing this to hearing children with autism,~     and deaf children without autism.~      The second stage is to ensure that the newly modified instruments are accessible to deaf~     children and deaf parents by making any necessary translations from English into British Sign~     Language. This involves a strict translation and back translation methodology with~     reiterations until successful translation is achieved.~      For stage three in order to ensure that the new questionnaires are successfully identifying~     children and young people with Autism Spectrum Disorder, the modified instrument will be~     validated using a 'gold standard'. The current 'gold standard' for the mental health~     screening of Deaf children is a clinical interview administered by experienced senior~     multidisciplinary deaf child mental health clinicians.~   "
124908|NCT01932502|"~     The purpose of the study is to examine the clinical safety, tolerability, and efficacy of~     clobazam (Onfi) when it replaces the pre-existing clonazepam therapy in patients with~     refractory epilepsy.~   "
124909|NCT01932489|"~     Prior to the use of genomic tests for patient inclusion in clinical trials, it is essential~     for the Jules Bordet Institute (JBI) to pilot the logistical and technical aspects by~     examining the feasibility and turnaround time of performing and obtaining data from a few key~     molecular assays.~      Patients with metastatic colorectal cancer, non-small cell lung cancer or melanoma will be~     enrolled. Biopsie from metastatic lesions will be performed. A targeted cancer gene screen~     assay will be performed using DNA sequencing.~      Results will be discussed during a molecular screening tumor board.~   "
124910|NCT01932476|"~     The purpose of this study is to determine whether the immune response causing celiac disease~     is related to the autoimmune response causing type-1 diabetes.~   "
124911|NCT01932463|"~     A feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR~     Guided Focused Ultrasound for Unilateral Thalamotomy in the Treatment of Tremor~   "
137977|NCT01761266|"~     E7080-G000-304 is a multicenter, randomized, open-label, noninferiority Phase 3 study to~     compare the efficacy and safety of lenvatinib versus sorafenib as a first-line systemic~     treatment in subjects with unresectable Hepatocellular Carcinoma (HCC).~   "
124912|NCT01932450|"~     A randomized, open-label single-center study investigates the efficacy and safety of~     bilateral renal artery sympathetic denervation by catheter-based radiofrequency ablation on~     blood pressure and disease progression control in autosomal dominant polycystic kidney~     disease(ADPKD). The total number of study subjects will be 100. All of them have diagnosed~     with ADPKD and hypertension. Patients will be randomized 1:1 (50 with radiofrequency~     ablation(RFA), 50 only with drugs). Change in average office-based measurements of systolic~     blood pressure(SBP), average 24-hour systolic blood pressure by ambulatory blood pressure~     monitoring (ABPM) , incidence of office systolic blood pressure reductions of ≥10, ≥15 and~     ≥20 mm Hg , office diastolic blood pressure (DBP), number and dosage of blood pressure~     tablets, total kidney volume (TKV), total cyst volume (TCV), pain related to cystic kidneys~     and renal function, will be assessed at 12 months of follow-up. The safety variables will be~     assessed at every visit of follow-up.~   "
124913|NCT01932437|"~     This study is to evaluate the safety and local tolerability of single intramuscular (IM)~     doses of ETI-204; to evaluate the pharmacokinetics (PK) of a single IM dose of ETI-204; and~     to evaluate the immunogenicity of a single IM dose of ETI-204.~   "
124914|NCT01932424|"~     During major spinal surgery evoked potential monitoring is performed to detect spinal cord~     damage. Intra-venous anaesthesia is the preferred anaesthetic technique because volatile~     anaesthetic agents supress the evoked potentials. Total Intra-Venous Anaesthesia (TIVA) with~     propofol is commonly administered as a Target Controlled Infusion (TCI). The TCI is an~     automated drug delivery system which administers propofol to achieve a desired blood~     concentration, based on an in built pharmaco-kinetic data (TCI model) derived from previous~     studies. The TCI model also provides a real time predicted blood concentration to facilitate~     the anaesthetist to adjust the target concentration of propofol.~      The TCI algorithm is based on pharmaco-kinetic data derived from previous studies in a~     relatively small number of patients, by a best fit relationship between blood levels,~     infusion rates and other factors (such as age and weight). Several factors make it possible~     for a wide discrepancy between the predicted and the true blood concentrations. This~     difference can be higher in children compared to adults. Also blood loss and administration~     of large volumes of intravenous fluids can affect the blood concentrations. This study aims~     to identify the difference between the predicted and true blood concentrations by using~     Pelorus 1500, a bedside blood propofol measurement device, in children undergoing major~     spinal surgery under TIVA.~   "
124915|NCT01932411|"~     Identify factors that contribute to perioperative morbidity and mortality in patients~     undergoing cardiac surgery that involves cardiopulmonary bypass.~      Identify factors that affect perioperative morbidity and mortality in patients undergoing~     cardiac surgery.~   "
124916|NCT01932398|"~     Investigate the hypothesis that children with ADHD have difficulty with the allocation of~     visio-spatial attention related to an inability to control posterior alpha brain~     oscillations. A paradigm will be used in which the aim is to address covert attention as~     similar recent studies did in adults with ADHD.~   "
124917|NCT01932385|"~     Due to the HBV and HCV infection, about 55% hepatocellular carcinoma patients happened in~     China. Among them, only 10% patients can be diagnosed in early stage. Sorafenib increased PFS~     and OS in advanced hepatocellular carcinoma patients with liver function of Child-Pugh class~     A patients, but the result for Child-Pugh class B patients is unclear.~   "
124918|NCT01932372|"~     The objective of this Surveillance is to verify the following subject matters concerning~     Tofacitinib (Xeljanz) under general practice.~      1) Occurrence of adverse reactions, factors that may potentially affect safety and efficacy~     2） Long-term safety (particularly, malignant tumors and serious infections) and efficacy~      Occurrences of malignant tumors and serious infections will be compared with a control group.~   "
124919|NCT01932359|"~     This study aims to compare scar outcomes between rapidly absorbable and non-absorbable~     sutures (stitches) for the closure of wounds after skin cancer removal on the face.~   "
124920|NCT01932346|"~     Near infra-red spectroscopy (NIRS) was used to measure the tissue perfusion of the cerebral~     cortex with two noninvasive adhesive patches in recent years. This study is designed to~     compare the regional tissue perfusion of different body areas in patients receiving coronary~     artery bypass surgery under general anesthesia. The NIRS data will also be used to compare~     with other routine physiological monitors in the surgery.~   "
124921|NCT01932333|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (what the~     body does to the study medication) and pharmacodynamics (the study of the action or effects~     the study medication has on the body) of single- and multiple, escalating oral doses of~     JNJ-40411813.~   "
124922|NCT01932320|"~     The purpose of this study is to compare the rate and extent of absorption of a single dose of~     two solid dose formulations relative to a nanosuspension formulation of JNJ-40411813 (Part~     1); to evaluate the effect of a high-fat/high-calorie breakfast on the rate and extent of~     absorption of the selected JNJ-40411813 solid dose formulation from Part 1 (Part 2); and to~     explore the influence of a potent inhibitor of CYP3A4, ketoconazole, on the rate and extent~     of absorption of the selected JNJ-40411813 solid dose formulation from Part 1 (Part 3).~   "
124923|NCT01932307|"~     There are currently no standardized programs addressing the well-documented neck pain in~     surgeons as a result of non-ergonomic positioning and the use of microsurgical equipment. The~     primary goal of this study is to introduce a brief neck strengthening exercise program to~     optimize surgeons' neck health. Instructional videos outlining the program along with surveys~     designed to assess attitude towards neck health will be distributed to first year general~     surgery residents at the University of British Columbia (UBC) through their required online~     curriculum webpage. A followup survey will be administered 10 weeks later to determine~     efficacy of the program through self-reported adherence and changes in attitude towards neck~     health.~   "
124924|NCT01932294|"~     Medamacs is a prospective, observational study of ambulatory patients with advanced heart~     failure. The study enrolls patients who have not yet received a Left Ventricular Assist~     Device (LVAD) but who receive their care at a hospital with a Joint Commission certified~     mechanical circulatory support program.~      Medamacs is funded through the Interagency for Mechanically Assisted Circulatory Support~     (INTERMACS) NHLBI Contract.~   "
138195|NCT01758432|"~     The purpose of this study is to evaluate the ability of PRT064445 to reverse the effects of~     several blood thinner drugs on laboratory tests. The study also is evaluating the blood~     levels of PRT064445 given at different doses.~   "
124927|NCT01932255|"~     Even at centers with very large experience, the risk of cerebrospinal fluid (CSF) leakage in~     surgery for microvascular decompression is reported up to 3%.~      Prevention of leakage is important since meningitis may follow. Also, leakage usually means~     longer hospital stay and increased cost.~      In case of detected leakage extra sutures may be applied, placement of a lumbar drain may be~     considered or a revision and improved closure may be attempted. With leakage in the~     subcutaneous tissue, but not through the skin, a local accumulation causing local symptoms~     may also occur. In addition to being burdensome and being associated with longer hospital~     stays with possible revision surgery, such complications are also very costly. The best way~     to reduce cost and burden, and to improve patient care, is to prevent CSF leakage.~      The aim of this study is to determine if prophylactic lumbar tap is beneficial for prevention~     of cerebrospinal fluid leakage following microvascular decompression, by comparison of~     surgical approaches in 3 geographical areas in the Scandinavian health system.~      Hypothesis: There is no difference in cerebrospinal fluid leakage between the group subject~     to prophylactic spinal tap versus the group without prophylactic spinal tap.~   "
124928|NCT01932242|"~     To evaluate the safety and tolerability of repeat administration (two doses) of intravenous~     (IV). To evaluate the pharmacokinetics and immunogenicity of ETI-204 after repeat IV~     administration.~   "
124929|NCT01932229|"~     Advanced lung cancer (non-small cell lung cancer) with a mutation in the EGFR (epidermal~     growth factor receptor) gene, which have disease progression after treatment with an EGFR~     inhibitor (erlotinib or gefitinib), and have progression of disease also after treatment with~     chemotherapy will be recruited. The trial has only one arm, of afatinib daily treatment.~     Blood and exhaled breath samples will be collected for investigations aiming to identify~     factors that predict response to afatinib.~   "
124930|NCT01932216|"~     Prospective, randomized , multicenter study comparing cholecystectomy performed with da Vinci~     Single Site Instruments™ to multi-port (four ports) laparoscopy~   "
124931|NCT01932203|"~     There may be a difference in efficacy of cilostazol and aspirin on progression of white~     matter changes in cerebal small vessel disease.~   "
124932|NCT01932190|"~     The best timing for renal replacement therapy (RRT) in intensive care unit (ICU) patients~     with acute kidney injury (AKI) is unknown. The investigators will conduct a multicenter~     prospective randomized open-label trial to compare two strategies in ICU patients~     (mechanically ventilated and/or receiving catecholamine infusion) with severe AKI defined as~     RIFLE F classification. These patients will be randomly allocated to one of the following~     strategies:~        1. an early strategy where RRT is started immediately when a RIFLE F status is documented~        2. a delayed strategy where RRT (in patients who also present RIFLE F renal failure) is~          started only in case of occurrence of one or more of the following events (Alert~          Criteria): oliguria or anuria lasting for more than 72 hours after randomization, serum~          urea concentration > 40 mmol /L, serum potassium concentration > 6 mmol /L, serum~          potassium concentration > 5.5 mmol /L that persists despite well-conducted medical~          treatment with at least sodium bicarbonate and / or glucose-insulin infusion, arterial~          pH < 7.15 in the context of pure metabolic acidosis (PaCO2 <35 mmHg) or in the context~          of mixed acidosis with PaCO2> 50 mmHg without possibility of lowering this PaCO2 value,~          acute overload pulmonary edema generating severe hypoxemia requiring oxygen flow> 5L/min~          in spontaneously breathing patients or FiO2> 50% in mechanically (invasive or~          noninvasive) ventilated to maintain SpO2> 95%, despite diuretic therapy.~      The primary endpoint is overall survival, measured from the date of randomization to the date~     of death, regardless of the cause. The minimum duration of each patient's follow-up will be~     60 days.~   "
124933|NCT01932177|"~     EVESOR multiparameter phase I trial aims at determining the safety of different doses and~     dosing schedules of everolimus in combination with sorafenib as well as the recommended doses~     & dosing schedules for phase 2 trials in adult patients with advanced solid tumors.~   "
124934|NCT01932164|"~     The aim of this study is to perform the bone tissue engineering to reconstruct the alveolar~     bone defect in cleft lip and palate patients using mesenchymal stem cells from deciduous~     dental pulp associated with a collagen and hydroxyapatite biomaterial (Geistlich Bio-Oss®)~     through prospective qualitative and quantitative analysis of bone neoformation.~   "
124935|NCT01932151|"~     Type 1 Hepatorenal syndrome (type-1 HRS) is a severe complication of patients with advanced~     cirrhosis characterized by marked renal failure and is associated with a very poor prognosis.~     Type-1 HRS is often precipitated by a bacterial infection, though it may occur spontaneously.~     It has been demonstrated that vasoconstrictor agents plus albumin are effective in the~     reversal of the renal failure. A large number of studies have shown that terlipressin~     improves renal function in patients with type 1 HRS; treatment is effective in 50-75% of~     patients approximately. Currently there are no specific studies about the treatment of type-1~     HRS with ongoing infections.~   "
124936|NCT01932138|"~     The purpose of this study is to determine the effectiveness, cost-effectiveness, feasibility~     and acceptability of an enhanced community health worker (CHW) intervention and outreach~     system to improve antenatal care and PMTCT uptake and retention, and to decrease~     mother-to-child HIV transmission.~   "
124937|NCT01932125|"~     This multicenter prospective observational study will evaluate the safety and efficacy of~     Avastin (bevacizumab) in routine clinical practice in patients with advanced/metastatic~     epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer. Data will be~     collected from eligible patients until death, withdrawal of consent, loss to follow-up, or~     study closure.~   "
124938|NCT01932112|"~     The investigators studied the effects of adenosine on the reconnection rate after successful~     pulmonary veins isolation by radiofrequency catheter ablation in patients with drug-resistant~     atrial fibrillation~   "
124939|NCT01932099|"~     A study to assess the safety and effectiveness of the Direct Flow Medical aortic valve~     system. This is for people with severe aortic stenosis who are not well enough to undergo a~     surgical repair. The delivery of this device is done via the femoral artery.~   "
124940|NCT01932086|"~     This study was an open, 5-treatment, 5-sequence, 5-day cross-over randomized design clinical~     trial. The present study was carried out to compare the effects of white rice, brown rice,~     and black rice on postprandial glucose and lipid profiles in healthy human subjects, using a~     white bread as a positive control.~   "
124941|NCT01932073|"~     Low Level Laser Therapy (LLLT) is a form of phototherapy which involves the application of~     light to injuries and lesions to promote tissue regeneration. It is a noninvasive treatment~     modality based on the photochemical effect of light on tissues, which modulates various~     metabolic processes.~      LLLT has been used for a wide range of conditions, in particular in dermatology, to promote~     wound healing, reduce inflammation and oedema, and relieve pain. In this study, we intend to~     assess the efficacy of LLLT to manage radiotherapy-induced skin reactions (or radiation~     dermatitis), a very common and distressing side effect of cancer treatment.~   "
124942|NCT01932060|"~     Although prior dose-finding studies have investigated the optimal bolus dose of oxytocin to~     initiate adequate uterine tone, it is unclear what oxytocin infusion regimen is required to~     maintain adequate uterine tone after delivery. The study investigators aim to compare two~     different infusion rates of oxytocin to assess the optimal infusion regimen for reducing~     blood loss in women undergoing elective Cesarean delivery.~   "
124943|NCT01932047|"~     ■ Unmet medical needs for Refractory cancer Conquest~      - Many advanced cancers are still detected Despite remarkable technological advances for the~     early diagnosis of cancer in the field last 20 years.~      In the type of progressive carcinoma is very high malignancy despite a variety of therapeutic~     target treatment for refractory cancer.~      The refractory cancer patients who main focus of this research defined as the adult solid~     tumor patients who have failed standard therapy according to the criteria~      NCCN / ASCO (American Society of imsangam) / KCSG (Study Group for chemotherapy).~      The survival rate of refractory cancer patients are estimated to be 30-40% of the total~     patients with metastatic solid tumors and these refractory cancers are~      difficult to deal with or control to conventional treatment so shows almost close to 100%~     mortality.~      Therefore the new development of therapies for conquer of refractory cancer are urgently~     required.~      ■ Preclinical translational research Unmet Needs of Bio-new drug development for conquer of~     refractory cancer~      - The stage of preclinical translational research (Translational Research) connects between~     the early stages of development and clinical trials in the stage drug development.~      The establishment of foundation based on the translational research is very necessary and~     this must have proven ability to treat refractory cancer.~      The most anti-cancer drugs developed by existing preclinical testing method actually does not~     show a remarkable effect in many cases in the clinical trials,~      even if showed a remarkable inhibitory cancer effect in animal testing.~      The exact molecular diagnosis to treat targets and paradigm for the development of new drugs~     at the same time requires for target treatment.~      The tailored cell lines by patients and the proven technology by animal models and unmet need~     for preclinical translational research is increasing~   "
124944|NCT01932034|"~     We will compare the percentage of patients having therapeutic vancomycin serum concentrations~     after current standard dosing, after dosing with our software. We will also include~     therapeutic outcomes and costs in the analysis.~   "
124945|NCT01932021|"~     The hypertensive leg ulcer is a very painful leg related to acute skin microangiopathy. It~     occurs in patients older than 60 years followed for hypertension. Clinical diagnosis requires~     eliminating other causes arterial ulcers, cryoglobulinemia, thrombophilia, cholesterol~     crystal emboli, vasculitis associated with hepatitis C, myeloproliferative disorders and~     ulcers associated with the Hydrea ® outlet.~      There is no treatment of the ulcer because conventional treatments are ineffective. The pain~     has subsided by analgesics III. Other treatments are not effective outside skin grafts to be~     repeated because they necrotic regularly. In a prospective uncontrolled study, 11 patients~     healed through autohemotherapy.~      Ineffective treatment of this painful condition and efficiency of these cells to the damaged~     tissue, due to the secretion of many bioactive molecules, led us to propose subcutaneous~     injections of autologous fat to change the wound bed, promote healing and eliminate pain.~     This treatment should help to avoid long-term hospitalization (about 15 days) that can lead~     to physical and psychological degradation of these elderly patients.~      The investigators propose an open clinical study of 10 patients with a single-center~     recruitment (CHU Caen). The study took place over a period of 18 months with a 12-month~     recruitment and follow-up of 6 months for each patient.~      The purpose of this study was to evaluate the one hand, tolerance, in terms of pain and side~     effects, and, on the other hand, the effectiveness of this therapeutic approach, in terms of~     healing of the ulcer assuming a decrease in the size of the estimated at least 40% at 3~     months wound. The measure of effectiveness will also focus on the changing appearance of the~     wound, including the relative areas of fibrin, necrosis and budding. These efficiency~     measures (area ratio) will be done through a computer program (CANVAS ®) on photographs taken~     at each assessment time.~      Eventually, if this study was to demonstrate the effectiveness of this treatment lipofilling,~     it would be possible to perform a multicenter study on a large number of patients to~     demonstrate the effectiveness, in terms of wound healing that the pain it causes and offer a~     shorter hospital stay, and in parallel, this approach should improve the pathophysiology of~     ulceration (translational research).~   "
124946|NCT01932008|"~     The purposes of this study are: (1) to compare the body composition, physical activity,~     physical function, and quality of life between patients with and without CKD after CABG; and~     (2) to analyze the relationships among body composition, physical activity, and physical~     function in this population. It is expected that patients after CABG with CKD have the worse~     body composition, physical function, and quality of life than patients after CABG without~     CKD; and patients with higher physical activity levels have the better body composition,~     physical function, and quality of life.~   "
124947|NCT01931995|"~     This research study is being done to gain a better understanding about brain networks that~     may be involved in depression. The investigators plan to examine how these networks change~     after the brain is stimulated with Transcranial Magnetic Stimulation (TMS). TMS is a way of~     stimulating the brain in order to mildly activate or mildly suppress different brain areas,~     and is used to treat some forms of depression. It is hoped that this study will facilitate~     learning more about the structure and function of different brain areas and the ways that~     they are interconnected to form networks, both in depressed people and in people without~     depression. In this research study, the effects of TMS will be measured by obtaining~     pictures of the brain with Magnetic Resonance Imaging (MRI) and with Positron Emission~     Tomography (PET). More specifically, this will be accomplished with a combined MRI and PET~     scanner, which is capable of simultaneously obtaining both MRI and PET images of the brain.~     This scanning paradigm will allow the assessment of local metabolic changes resulting from~     TMS (with PET images) and brain network changes resulting from TMS (with fMRI). Changes~     resulting from TMS between 20 subjects with depression and 20 healthy volunteers will be~     calculated and will form the main outcome measure.~   "
124948|NCT01931982|"~     The purpose of the study is to determine if a GLP-1 agonist improves microvascular perfusion~     in the heart of patients with type 2 diabetes~   "
124949|NCT01931969|"~     This study is planned to compare right internal jugular vein catheterization entry points~     determined by ultrasound and the central landmark guided method, and the relationship of each~     with sternocleidomastoid muscle length and body mass index.~   "
124950|NCT01931956|"~     Prospective, multicenter, continued access registry of the MitraClip® Cardiovascular Valve~     Repair System in the treatment of mitral valve regurgitation. Patients will undergo 30-day,~     6-month, 12-month, 36-month and 60-month clinical follow-up. The study consists of two arms:~     a High Risk group (NCT01940120) and a Non-High Risk group (NCT00209274) . Patients that did~     not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for~     consideration for either Emergency Use (EU) or Compassionate Use (CU).~   "
124952|NCT01931930|"~     In the current study the effects of proprietary Perilla frutescens leaf extract in comparison~     to Maltodextrin, a fully digestible carbohydrate (placebo control), on gastrointestinal~     discomfort and bowel function were investigated. The study was performed double-blind and~     placebo-controlled with a 4 week intervention period. Study products were taken two times~     daily (each one capsule before breakfast and dinner).~   "
124953|NCT01931917|"~     The purpose of the pilot study is to examine the effects of the Incredible Years Baby~     Programme (IY baby) offered as a universal intervention compared to Usual Care (UC) for~     parents with infants aged 0-12 months.~   "
124954|NCT01931904|"~     The purpose of this study is to determine if lowering the pressure inside the eye improves~     blood flow to the eye.~   "
124955|NCT01931891|"~     Preeclampsia affects 2% to 8% of all pregnancies and is a major cause of maternal morbidity~     an mortality worldwide.Althought the primary pathology leading to preeclampsia is remain not~     known, complex pathophysiologic pathways and mechanisms have been described.~      New blood vessels evolve during angiogenesis and vasculogenesis, two physiological processes,~     that play a crucial role in embryogenesis and placentation. Structural alterations in the~     human umbilical cord, maternal spiral arteries can cause adverse fetal~     consequences.Pre-eclampsia is accompanied by an extensive remodelling of the ECM of the~     umbilical cord. Pre-eclamptic Wharton's jelly contains higher amounts of glycosaminoglycans~     in comparison to control tissue.~      Matrixmetalloproteinases (MMPs) are a family of proteolytic enzymes that degrade various~     components of the extracellular matrix (ECM). A Disintegrin And Metalloproteinases (ADAMs)~     and ADAMs with Thrombospondin motifs (ADAMTS) are proteinases closely related to Matrix~     Metalloproteinases (MMPs). Dysregulation of ADAMs and ADAMTS expression have been reported in~     different types of pathologies such as cancer, osteoarthritis, neurodegenerative inflammation~     or asthma.~      The role of ADAMTS in the pathomechanism of pre-eclampsia has not been studied until now. We~     therefore decided to compare the ADAMTS composition of the umbilical cord and placenta from~     newborns of mothers with pre-eclampsia with those with normal pregnancy.~   "
124956|NCT01931878|"~     The purpose of this research study is to compare the safety and effectiveness of local~     injections of botulinum toxin A (Xeomin®) to an inactive test substance (placebo) in a~     medical condition called Restless Leg Syndrome. This study has a double blind cross over~     design. Cross over means that you will have two sets of injections. The first set of~     injections can be either Xeomin or placebo. The order of injection will be reversed at the~     three month point following the first injection. Double blind means neither the investigators~     nor you know which one of the two (Xeomin or placebo) you received.~   "
124957|NCT01931865|"~     The purpose of this research study is to investigate the safety and effectiveness of~     botulinum toxin A (Xeomin) ® injections in patients who suffer from focal pain in areas of~     radiation and/or surgery as a result of cancer treatment. Our hypothesis is that injection of~     incobotulinum toxin A into an area of local pain, at or around the area of a~     post-surgical/post radiation scar, relieves the focal cancer pain.~   "
124958|NCT01931852|"~     The broad, long-term objective is to improve outcomes by optimizing healthcare delivery~     processes for patients with detectable to elevated serum troponin. This clinical trial~     involving emergency department (ED) patients with intermediate to high-risk chest pain and~     detectable to minimally elevated serum troponin within 6 hours of evaluation.~   "
124959|NCT01931839|"~     The purpose of this study is to evaluate the efficacy and safety of long-term treatment with~     lumacaftor in combination with ivacaftor in people 12 years and older with Cystic Fibrosis.~   "
124960|NCT01931826|"~     Upper gastrointestinal bleeding (UGIB) is a major cause of morbidity and mortality in~     patients with portal hypertension secondary to schistosomiasis mansoni. Taking into account~     the endemic nature of schistosomiasis mansoni in our region and the high morbidity and~     mortality directly associated with rupture of esophageal varices and UGIB in affected~     patients, we conducted a prospective randomized trial in patients with schistosomiasis and a~     history of bleeding esophageal varices. Its purpose was to assess the efficacy of endoscopic~     treatment alone compared with the efficacy of sclerotherapy preceded by a surgical treatment:~     Esophagogastric devascularization with splenectomy (EGDS).~   "
124961|NCT01931813|"~     This project is the pilot step necessary to develop a system of vaccination~     pharmacoepidemiology that associates a sophisticated analytical approach, appropriate for~     this challenge and case series analysis, with the use of linked medicoadministrative data for~     hospitalisations the reimbursement of healthcare costs. This linkage of medicoadministrative~     data is new in France. The example of the risk of hospitalisation for febrile convulsions in~     infants less than two years old following vaccination against diphtheria, tetanus and~     pertussis is given as the reference association. This choice is justified by the numerous~     publications over many years on the existence of this association (Miller et al BMJ 1981,~     Farrington et al Lancet 1995). In addition, as case series analyses have been carried out to~     assess this risk, the results can be compared directly (Lancet 1995). The study to determine~     whether the analysis tools are suitable for the data will be tackled at the following levels:~        -  Validity of the selection of cases from administrative records alone using coding based~          on the international classification of diseases ICD10~        -  Validity of the risk assessment. This methodology feasibility project must make it~          possible to identify the different potential problems. This is a prerequisite necessary~          for the systematic implementation.~   "
124984|NCT01931514|"~     Objective:~      Primary objective of the present study was to compare the single dose bioavailability of~     Torrent's Montelukast Sodium chewable 5mg tablet and Innovator's(Merck)Singulair chewable 5mg~     tablet. Dosing periods were separated by a washout period during fed study.~      Study Design:~      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence~     Study~   "
124985|NCT01931501|"~     Objective:~      Primary objective of the present study was to compare the single dose bioavailability of~     Torrent's Montelukast Sodium chewable 5 mg tablet and Innovator's(Merck)Singulair chewable 5~     mg tablet. Dosing periods were separated by a washout period during fasted study.~      Study Design:~      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence~     Study~   "
124986|NCT01931488|"~     The Feasibility of Novel 124I-MIBG Tracer in Evaluation of Myocardial Sympathetic Denervation~     and Assessment of Neuroendocrine tumors. Comparison with 123I-MIBG.~   "
124962|NCT01931800|"~     -  4 tubes (2 x7-ml dry tubes with yellow gelose, and 2 x 5 ml tubes with blue CTAD) will~          be taken from the patient within 24 hours following inclusion (D0) in the department in~          which the patient is hospitalised~        -  4 tubes (2 x7-ml dry tubes with yellow gelose, and 2 x 5 ml tubes with blue CTAD) will~          be taken from the patient every 7 days following inclusion for 5 weeks (if the patient~          is still in hospital at the time), in the department where he/she is hospitalised (D7,~          D14, D21, D28, D35). Samples will no longer be taken once the patient has left the CHU,~          even if all of the samples have not been taken.~        -  For children less than 6 years old, only 2 tubes (1 x 7 ml dry tube with yellow gelose,~          and 1x5 ml tube with blue CTAD) will be taken following the same timetable.~        -  For hospitalised patients, a leeway of 48 hours is authorized for the sampling~          procedure. Samples will be taken at the same time samples are taken for the usual care~          of the patient.~        -  The tubes will be taken to the Bacteriology Laboratory using the usual collection~          circuit of the CHU. These tubes will then be redirected to the Infectious Diseases~          Laboratory to be centrifuged and then stored at -80°C. The strain of Streptococcus~          pneumoniae isolated in the patient will be preserved at -80°C. If strains other than~          Streptococcus pneumoniae are isolated, these different strains will all be preserved at~          -80°C under the same identification number.~   "
124963|NCT01931787|"~     This pilot clinical trial studies CPI-613 (6,8-bis[benzylthio]octanoic acid) in treating~     patients with relapsed or refractory small cell lung cancer. CPI-613 may interfere with the~     growth of tumor cells and may be an effective treatment for small cell lung cancer.~   "
124964|NCT01931774|"~     Acne vulgaris usually causes psychological distress, depression, and anxiety disorders that~     may impair neurocognitive functions such as memory, attention, psychomotor speed, and~     executive functions, which are also common psychiatric disorders in patients with acne.~      The purpose of this study is to determine cognitive functioning in treatment naive acne~     patients, without a history of any psychiatric disorder.~   "
124965|NCT01931761|"~     To evaluate the absorption, distribution, metabolism and excretion (ADME) of single dose~     [14C] selumetinib in volunteers~   "
124966|NCT01931748|"~     The Purpose of this study is to evaluate in a randomized, double-blind, Parallel,~     Non-inferiority, Multicenter, the efficacy and safety of UNCNT in comparison to the active~     comparator of MELSMON in female having menopausal syndrome. Patients will be allocated~     randomly to receive either UNCNT or MELSMON.~      Through the injection of UNCNT to female having menopausal disorder, efficacy in the~     improvement of the menopausal symptoms by Kupperman index is to be evaluated and compared~     with MELSMON.~   "
124967|NCT01931735|"~     Arthroscopic meniscectomy is among the most commonly performed orthopedic surgical procedures~     in the VA system. There remains substantial uncertainty, however, regarding the short term~     benefits and the long term consequences of arthroscopic meniscectomy in patients with~     degenerative meniscus tears. Of major concern is the fact that degenerative meniscus tears~     are associated with osteoarthritis, and it is known that within two years of surgery,~     arthroscopic debridement for osteoarthritis is no better than placebo in relieving pain and~     restoring function. Longer term, meniscectomy has been shown to be associated with elevated~     risk of osteoarthritis development, raising the concern that meniscectomy can actually be~     harmful. The purpose of this study is to determine whether meniscectomy in the setting of a~     degenerative meniscus tear is of any clinical value. Determining this would either justify~     the expenses associated with arthroscopic meniscectomy on a large number of patients, or~     would identify an area of significant potential cost savings.~   "
124968|NCT01931722|"~     Likely, branched chain amino acid (BCAA) requirements are increased in older strength-trained~     (ST) individuals. If so, supplementation in this group will maximize muscle protein synthesis~     (MPS) and minimize loss of muscle with age (sarcopenia).~   "
124969|NCT01931709|"~     This clinical trial studies fludeoxyglucose F 18 (FDG) positron emission tomography (PET) and~     dynamic contrast-enhanced (DCE)-magnetic resonance imaging (MRI) in predicting response to~     treatment in patients with breast cancer. Comparing results of diagnostic procedures done~     before, during, and after chemotherapy may help doctors predict a patient's response to~     treatment and help plan the best treatment.~   "
124970|NCT01931696|"~     The purpose of this study is to assess whether acupuncture is effective in the treatment of~     chronic asthma.~   "
124971|NCT01931683|"~     The investigators attempted to determine the optimal effect-site concentration of~     remifentanil for smooth removal of the LMA from propofol anesthesia.~   "
124972|NCT01931670|"~     A randomized study evaluating the safety and efficacy of elagolix in the management of~     moderate to severe endometriosis-associated pain in adult premenopausal female subjects.~   "
124973|NCT01931657|"~     Hypothesis: Pretreatment with mifeprsitone prior to Mirena placement will induce amenorrhea~     and reduce bleeding irrregularities during the initial months of Mirena use.~   "
124974|NCT01931644|"~     At Sanguine, we consider ourselves the bridge between patients and researchers striving to~     find new treatments and diagnostics for numerous medical conditions. We collect biospecimens~     such as blood for medical researchers. Donate from your home, track your sample, and help~     advance medical research.~   "
124975|NCT01931631|"~     The purpose of the study is to assess whether, in individuals with type 2 diabetes, a~     low-fat, vegan diet improves blood glucose control more effectively than a control diet based~     on current American Diabetes Association (ADA) guidelines. The principal measure is~     hemoglobin A1c. Cardiovascular risk factors and dietary acceptability are also assessed. The~     study duration is 20 weeks with a one-year follow-up.~   "
124976|NCT01931618|"~     The purpose of this study is to test - in a workplace setting - if an online multi-session~     alcohol intervention improves treatment effect over and above a single session screening with~     feedback.~      Hypothesis: automated online multi-session follow-up improves the effect on alcohol~     consumption over and above a single session screening~   "
124987|NCT01931475|"~     The purpose of this study is to assess the efficacy and safety of duloxetine once daily~     compared with placebo on the reduction of pain due to osteoarthritis (OA) in knee or hip in~     participants in China.~   "
125344|NCT01926808|"~     The purpose of this study is to try to correlate vitamin D dosing and dosing adjustment with~     Vitamin D levels, measure affects of seizure medications on levels as well as pathologic~     fractures and bone density in severely cognitively impaired, non-mobile children and~     adolescents with CP.~   "
124977|NCT01931605|"~     Background: Patients with indwelling urinary catheter for chronic retention due to~     obstructive BPH refractory to medical therapy are candidates for prostatectomy still~     considered as the gold standard of treatment. Urinary tract infection, strictures,~     postoperative pain, incontinence, sexual dysfunction, anesthesiologist risk and blood loss~     are complications associated with surgery. Minimally invasive treatments were originally~     conceived as an attempt to offer equivalent efficacy without the burden and risk of operative~     morbidity. Recently, it was suggested that prostatic arterial embolization (PAE) to treat BPH~     might follow uterine artery embolization for uterine leiomyomas. Animal studies in pigs and~     dogs have shown that PAE is safe and can induce prostatic volume reduction. The first report~     of this technique in the management of BPH in humans was by DeMeritt et al, who reported a~     single case of BPH with obstructive symptoms and blood loss refractory to other treatments~     that was successfully managed by PAE with polyvinyl alcohol (PVA) particles.~      Objective : We investigate whether PAE might be a feasible procedure as an alternative~     treatment option to treat urinary retention due to obstructive BPH. The primary objective is~     to evaluate the success rate of procedure defined when selective prostatic arterial~     catheterization and embolization were achieve and patients can be able to urinate after their~     urinary catheter has been removed.~      Patients and methods : A monocentric prospective study is undertaken in 25 patients aged~     50-85 years who present with indwelling urinary catheter due to obstructive BPH refractory to~     medical treatment with a clinical indication for surgery who agreed to undergo PAE. The study~     is approved by the hospital ethical committee and an informed consent form for PAE as an~     alternative treatment is signed by all participants.~      Statistical analysis : The sample size has been calculated in order to have an estimated~     probability of success (corresponding of primary objective) of 50% (worst case) with 95%~     confidence intervals of 30 to 70. The two-sample t-test (and Wilcoxon rank-sum test) is used~     to compare the mean changes of the variables from baseline to 10, 30 and 90 days. Finally,~     the Chi-square test is used to test for adverse events at the end of follow-up. P ≤ 0.05 is~     indicative of statistically significant.~   "
124978|NCT01931592|"~     Rapid and rational health-care interventions are of great importance to efficiently combat~     the emergence of resistant and virulent bacteria. In recent years, spread of ESBL-E on a~     global level has been observed.~      For ESBL-E, effective eradication regimens are not yet available. The current study therefore~     aims to assess a new approach to ESBL-E eradication. To avoid administration of the~     eradication regimen to patients at low risk of subsequent BSI with ESBL-E, the study~     population will be restricted to immunocompromised high-risk patients.~   "
124979|NCT01931579|"~     Solitary pulmonary nodule has become a major challenge in respiratory clinical practice.~     According to published guidelines, their management often requires close CT follow up, PET CT~     and invasive procedures to obtain a definite histology. In this context, innovative~     endoscopic techniques refered as navigational bronchoscopy have proved to be efficient, for~     the localization and sampling of peripheral lung nodules. However, these techniques are~     unable to differentiate malignant lesions from benign ones, in-vivo, in real time. Confocal~     endo-microscopy (CELLVIZIO) of the distal lung - also refered as distal lung probe based~     confocal laser endo-microscopy or alveolar lung endo-microscopy - allows in-vivo imaging of~     the distal lung structures in real time.~      This prospective trial we will assess confocal endoscopy as a tool to localize the peripheral~     lung nodules and to differentiate benign from tumoral lesions.~      Objective(s)~        1. To demonstrate that confocal endo-microscopy is not inferior to navigational endoscopy~          for the localisation of peripheral lung nodule~        2. To demonstrate that confocal endoscopy can differentiate benign from malignant tumors~      Experimental design:~      Multicentric prospective controlled trial, conducted in three academic centers, specialized~     in interventional bronchoscopy, equipped with both navigational bronchoscopy and probe based~     confocal endo-microscopy.~      Subjects with peripheral lung nodule requiring navigational bronchoscopy will be explored~     using both Confocal endoscopy AND navigational bronchoscopy. Confocal probe will be inserted~     in the same catheter as used for the navigational bronchoscopy and confocal images will be~     recorded before sampling. An ancillary study using topical methylene blue as in situ will be~     conducted at the Rouen University Center.~      An ancillary protocol includes the use of in situ methylene blue deposition and 660 confocal~     endo-microscopy analysis.~   "
124980|NCT01931566|"~     The purpose of this study is to qualify the biomarker risk algorithm for prognosis of the~     risk of developing Mild Cognitive Impairment due to Alzheimer's Disease (MCI-AD), and also to~     evaluate the efficacy of pioglitazone compared with placebo to delay the onset of MCI-AD in~     cognitively-normal participants who are at high-risk for developing MCI within 5 years.~   "
124981|NCT01931553|"~     Attending morning rounds take place at teaching hospitals every day. They are the primary~     mechanism for patient care delivery, supervision and education of trainees, and communication~     with patients, families, and staff. However, they are done with little standardization or~     widely recognized best practices.~      The objective of this quality improvement (QI) initiative is to evaluate the adherence to and~     impact of implementing standardized attending morning rounds on medicine teams at our~     institution. A standardized rounding intervention has been developed which includes specific~     guidance on completing the following activities during morning rounds: (1) Pre-rounds~     discretion; (2) Pre-rounds huddle; (3) Bedside registered nurse (RN) integration; (4)~     Patient-centered rounding; (5) Real-time order writing.~      This trial will randomize half of the investigators' medicine teams at University of~     California San Francisco to this rounding intervention whilst the other half will be~     randomized to continue with usual unstandardized rounding practices.~      The investigators will compare medicine teams randomized to undertake standardized rounding~     to those teams undertaking usual practice. Outcomes assessed will relate to the patient (e.g.~     satisfaction), providers (e.g. satisfaction), efficiency (e.g. total morning round time) as~     well as adherence to the intervention .~      The investigators' study hypotheses are that patient satisfaction scores will be higher for~     those patients receiving standardized bedside rounds compared to the usual care group. The~     investigators also hypothesize that total attending morning rounds time and interns length of~     workday will be shorter and that the number of consultations ordered before noon will~     increase for those teams undertaking standardized bedside. Further, the investigator~     hypothesize higher levels of nurse participation, physician and medical student satisfaction~     with standardized bedside rounding.~   "
124982|NCT01931540|"~     The prevalence of obesity in the developed world has increased markedly over the last 20~     years. Considering the prevalence of obese and overweight adult subjects, and the fact that~     pregnancy itself induces a state of insulin resistance and inflammation, maternal obesity may~     be the most common health risk for the developing fetus. It is well established that what we~     eat has a major impact on our health. However, there is growing evidence to suggest that diet~     during pregnancy and lactation may be particularly important as not only does it influence~     the health of the mother, it may have a permanent effect on the health of her children and~     even her grandchildren. The concept that environmental factors, such as nutrition during~     early development, influence both our health span and lifespan has been termed the~     developmental origins of health and disease hypothesis.~      The objective of the study are:~        -  to compare subjects with frailty (condition developed with ageing) with controls and~          characterize the unhealthy aged condition with the measurements described below~        -  to examine if signs of frailty can be reversed by lifestyle induced modifications~          (exercise training programme) of its primary components (IR, sarcopenia, psychological~          profile) in offspring of overweight/obese (OOM) vs lean mothers (OLM).~      The study consists of 37 frail old subjects, age ≥ 65 sub-grouped in 17 OOM, and 20 OLM and~     11 non frail controls. These subjects will be studied with positron emission tomography~     (PET), computed tomography (CT), magnetic resonance imaging (MRI) and spectroscopy (MRS) and~     ultra sounds (US). In addition functional MRI (fMRI) will be performed. Adipose tissue~     biopsies will be taken.~      Subjects will undergo characterization of biohumoral markers, a 75 g oral glucose tolerance~     test, imaging biomarkers (PET/CT, US, fMRI-MRS), genetic biomarkers (DNA and telomere damage)~     and inflammatory biomarkers (macrophage infiltration) before and after the 4-month lifestyle~     intervention period (physical exercise). By PET/CT it will be measured tissue-specific IR in~     skeletal muscle, adipose tissue, liver, myocardium and targeted brain regions. MRS will be~     used to measure organ steatosis in the skeletal muscle and liver, MRI will be used to measure~     fat masses in abdominal areas, and fMRI will be performed to assess activation in brain~     regions regulating cognition and appetite/energy control. US will be used to assess~     cardiovascular markers (IMT, strain and function).~   "
124983|NCT01931527|"~     The purpose of this study is to learn more about what is the effect of uric acid on oxidative~     stress and on the way the body metabolizes sugar in obese people. Understanding this may lead~     to better diseases such as diabetes.~   "
125000|NCT01931306|"~     To provide expanded access and to evaluate the safety, tolerability and efficacy of afatinib~     in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring~     Epidermal Growth Factor Receptor (EGFR) mutation(s) and have never been treated with an EGFR~     tyrosine kinase inhibitor (TKI)~   "
124988|NCT01931462|"~     Partial nephrectomy (kidney removal) is a standard therapy for clinical T1 renal (kidney)~     tumors. The goals of surgery are to accurately remove the tumor with no cancer cells at the~     edge of the remaining tissue, to limit blood loss, and preserve kidney function. The most~     common technique is to clamp the blood supply to the entire kidney during removal and to~     surgically repair the tumor bed with suture and agents to stop bleeding. This stops the blood~     supply to the entire kidney including the healthy tissue, which can cause damage to the~     remaining tissue due to a shortage of oxygen if left clamped too long.~      This study uses a microwave pre-coagulation technique using the Certus 140™ to facilitate a~     bloodless area near the tumor for accurate tumor removal and repair, while avoiding clamping~     the blood supply, but its effect on the function of kidney adjacent to tumor is unknown. If~     adequate stoppage of bleeding is achieved using the Certus 140™ with minimal heat spreading~     to the remaining tissue, clamping and a shortage of oxygen can be avoided.~      The hypothesis is that microwave pre-coagulation is a safe method for providing the stoppage~     of bleeding during partial kidney removal.~   "
124989|NCT01931449|"~     The purpose of this study is to evaluate the validity and safety of a modified operative~     procedure of digestive tract reconstruction following pancreatoduodenectomy which enables the~     pancreatic juice and bile to bypass at the pancreatointestinal anastomosis and merge at~     gastrointestinal anastomosis. It is anticipated that this procedure can decrease the risk of~     post-surgical pancreatic leakage and preserve the patients' digestive function as well.~   "
124990|NCT01931436|"~     This study will investigate the pharmacokinetics of single and multiple doses of Qing'E pills~     in Chinese menopause volunteers. The main components of Qing'E pill into the blood such as~     psoralen and Isopsoralen will be detected.~   "
124991|NCT01931423|"~     To determine whether early placental drainage plus cord traction reduces the incidences of~     manual removal and blood loss, and to determine the risk factors associated with blood loss~     after delivery.~   "
124992|NCT01931410|"~     The investigators hypothesis in this study is that administration of rectal and sublingual~     misoprostol decreases intrapartum and postpartum haemorrhage.~   "
124993|NCT01931397|"~     Kidney transplantation is the treatment of choice for kidney failure in children. Kidney~     transplant recipients need to take immunosuppression for the rest of their lives after~     transplantation to prevent rejection of the graft. One of the important medications is called~     Tacrolimus which can prevent rejection of the kidney graft but at the same time is toxic to~     the kidney. Therefore, repeated blood levels of Tacrolimus with tests of kidney function will~     help physicians to prescribe the best dose for therapy to prevent kidney rejection and kidney~     toxicity. Failure of compliance with taking Tacrolimus is also an important cause of graft~     failure especially among teenagers, so repeated blood Tacrolimus levels are necessary to~     detect patients who fail to take their medications on a regular basis. We have developed a~     lab assay that measures Tacrolimus blood level and creatinine (for kidney function) using one~     dried blood spot (DBS) on filter paper similar to the filter paper used in the new born~     screen. We plan to teach patients how to do the test at home once a month and mail the filter~     paper back to OHSU for analysis for Tacrolimus and creatinine. The advantage of this method~     is that it is less painful for children then a regular blood dray from the vein, can be done~     easily at home, will be most cost effective as it will save the family a day of work or~     school and can detect both the Tacrolimus level and the kidney function at the same time.~      We will assess the effect of doing this simple finger prick at home on compliance, on~     Tacrolimus levels and kidney function over the study period of one year. We will also assess~     how satisfied patients are with this method instead of going to the lab or the hospital for~     blood test. All subjects will continue on their regular clinic visits and will continue to~     have their routine blood draws by intravenous method in the lab during the study.~   "
124994|NCT01931384|"~     A randomised trial on the use of luteal phase support in frozen-thawed embryo transfer~     cycles.~      The hypothesis of the study is that the use of luteal phase support with human chorionic~     gonadotrophin would increase the pregnancy rate in frozen-thawed embryo transfer cycles.~   "
124995|NCT01931371|"~     The purpose of this study is to determine whether anal fistula plug or endorectal advancement~     flap is more successful in the treatment of anal fistulas and compared both procedures with~     regards to cost.~   "
124996|NCT01931358|"~     The primary purpose of the study is to better define the relative contributions of AIDSVAX®~     B/E alone, ALVAC-HIV alone, or ALVAC-HIV plus AIDSVAX® B/E combination to the observed immune~     profile in the weeks and months after receiving the original prime and boost vaccine regimen~     from study protocol RV 144, and their booster effects in both the systemic and mucosal~     compartments. In addition, this study will provide more intensive and comprehensive~     characterization of the innate, cell-mediated and humoral immune responses than possible~     within the RV 144 study.~   "
124997|NCT01931345|"~     In 2009, a team of researchers from Montreal, Canada, implemented SPOT, an intervention aimed~     at reducing HIV transmission among men who have sex with men by offering rapid HIV testing in~     a community setting. During the first phase, counseling based on Quebec guidelines for rapid~     HIV testing was offered (standard counseling - SC) and in the second phase, counseling based~     on motivational interviewing (MIC) was developed and validated. The current phase of the~     project aims to strengthen the work undertaken during previous phases. The objective of the~     study is to assess the short and medium term effect of MIC on the occurrence of at-risk anal~     intercourse and its cognitive determinants. Participants will be randomly assigned to either~     SC or MIC, and will respond to a baseline questionnaire documenting their sexual behavior and~     psychosexual profile prior to the intervention at the start of their initial visit (T0). The~     effect of counseling will be assessed following the intervention at the end of the initial~     visit (T1), at 3 months after the initial visit (T2) and at 6 months after the initial visit~     (T3).~   "
124998|NCT01931332|"~     Primary total knee arthroplasty (TKA) is commonly associated with moderate to severe early~     post-operative pain. The primary aim of this study was to investigate the impact of either a~     single-shot femoral nerve block (FNB) or intrathecal diamorphine (ID) on post-operative pain~     after TKA~      The Null Hypothesis is that there is no difference in the post operative pain relief provided~     for TKA by a single-shot femoral nerve block (FNB) as compared to intrathecal diamorphine~     (ID).~   "
124999|NCT01931319|"~     The objective of this study is to determine safety and characterize pharmacokinetics of~     higher doses of intravenous baclofen in healthy subjects.~      This study is a non-randomized dose escalation study. Three subjects will receive 10 mg doses~     of IV baclofen, two or more days later the next three subjects will receive 15 mg baclofen~     intravenously, and two or more days later the last three subjects will receive 20 mg IV~     baclofen.~      The pharmacokinetic and tolerability information gained from this study will support the~     development of further studies to assess the use of IV baclofen to prevent or treat baclofen~     withdrawal syndrome.~   "
144239|NCT01679379|"~     The purpose of this study is to determine the surgical site infection rate and patient~     satisfaction for absorbable versus non absorbable suture in closure of skin at cesarean~     section in obese women.~   "
125001|NCT01931293|"~     Patients with atrophic glossitis (AG) or burning mouth syndrome (BMS) are frequently~     encountered in the oral mucosal disease clinic. Our previous studies found a significantly~     higher frequency (26.7%) of serum gastric parietal cell antibody (GPCA) and a significantly~     higher frequency (31%) of serum thyroglobulin antibody (TGA) or thyroid microsomal antibody~     (TMA) in AG patients than in healthy control subjects. Moreover, there is also a~     significantly higher frequency (13.3%) of serum GPCA or a significantly higher frequency~     (23.5%) of serum TGA or TMA in BMS patients than in healthy control subjects. Because~     patients with one organ-specific autoantibody are prone to have another organ-specific~     autoantibody in sera, we also evaluated whether AG or BMS patients with GPCA are prone to~     have TGA or TMA in sera and vice versa. We further found that 25.3% of TGA- or TMA-positive~     AG or BMS patients also have GPCA, 32.3% GPCA-positive AG or BMS patients also have TGA, and~     30.6% GPCA-positive AG or BMS patients also have TMA in their sera. Without proper diagnosis~     and treatment, patients with GPCA are more likely to develop autoimmune atrophic gastritis~     and subsequently progress to gastric carcinoma, and patients with TGA or TMA may develop~     autoimmune thyroid disease and finally result in thyroid dysfunction. In addition, previous~     studies have shown a close association of the HLA-DR or HLA-DQ loci with the presence of~     autoantibodies (such as GPCA, TGA or TMA) in patients with different types of autoimmune~     disease. Therefore, in the following 3-year research project, we plan to collect 300 AG and~     450 BMS patients from the oral mucosal disease clinic of Department of Dentistry, National~     Taiwan University Hospital. For each year, 100 AG and 150 BMS patients are collected. A 10-cc~     blood sample will be drawn from each patient, with 5 cc being used for the determination of~     the serum levels of GPCA, TGA and TMA and another 5 cc being used for the HLA-DRB1 and~     HLA-DQB1-genotyping using the polymerase chain reaction with sequence-specific primer~     (PCR-SSP) typing technique. At the end of this 3-year study, we will realize the frequencies~     of presence of GPCA, TGA and TMA in sera of our 300 AG or 450 BMS patients. After statistical~     analyses, we will also know which specific HLA-DRB1 or HLA-DQB1 allele and which specific~     DRB1-DQB1 haplotype are responsible for the possession of GPCA, TGA or TMA in sera of our AG~     or BMS patients. In addition, we will understand which specific HLA-DRB1 or HLA-DQB1 allele~     and which specific DRB1-DQB1 haplotype are responsible for the possession of GPCA in TGA- or~     TMA-positive AG or BMS patients as well as for the possession of TGA or TMA in GPCA-positive~     AG or BMS patients. With this important information in mind, we can predict the development~     of the specific autoimmune diseases such as autoimmune atrophic gastritis and autoimmune~     thyroid diseases and then adopt proper early diagnosis and treatment to prevent the future~     occurrence of these diseases and their potential complications (such as gastric carcinoma or~     thyroid dysfunction).~   "
125002|NCT01931280|"~     This study includes a behavioral educational intervention that focuses on healthy eating,~     physical activity and glucose management during pregnancy and post partum among women newly~     diagnosed with gestational diabetes mellitus (GDM).~   "
125003|NCT01931267|"~     The purpose of this 4-year study is to investigate the relationship between cognition and~     learning ability on patients with COPD during hospitalization to establish and evaluate the~     effects of the community-extended discharge planning program. The transition theory is used~     as the theoretical base in this study. The patients with diagnosis of COPD in hospital will~     be invited to participate. The data of demographic variables, the cognitive function¸ the~     respiratory function, the effect of learning and the usage of medical resources after~     discharged will be collected. In the first year, we will establish the protocol of~     respiratory teaching in two modes, and to compare the differences among computer interaction~     game intervention, face to face teaching and routine nursing intervention, also to evaluate~     the related factors and the effect of learning on patients with COPD for determining the~     needs of patients' learning mode and the optimal frequency of nursing teaching mode during~     hospitalization in the second year. For the second year, build upon the results of the first~     year, the preliminary draft of the community-extended discharge planning program that base on~     the experts' meeting and the interview with the patients. Also, a pilot study that revising~     the content and testing the feasibility of respiratory teaching protocol will be conducted.~     For the 3rd and 4th year, using case-control RCT design, the community-extended discharge~     planning program will be tested in patients during their hospital stay and post-discharge~     period. The effects of this community-extended discharge planning program will be evaluated~     on outcome variables of patients' cognitive learning function, utilization of health care~     resources. The results of this study will help to develop a community-extended discharge~     planning for patients with COPD on cognition level and learning ability. Furthermore, the~     protocol of the community-extended discharge planning will serve as references to prolong the~     development of disease deterioration, reduce the probability of readmission and improve the~     quality of life.~   "
125004|NCT01931254|"~     In the past 70 years antibiotics have served as the first line of defense against infectious~     diseases. However, antibiotics are only effective against bacterial infections and are not~     the solution for infections caused by viruses such as common colds or flu. Despite their~     contribution to healthcare, antibiotics are currently recognized as the most misused drugs in~     the world with global overuse estimated at 40%-70%, mostly due to the ineffectiveness of~     current diagnostic solutions to distinguish between bacterial and viral infections.~     Antibiotics misuse often causes preventable adverse events that impact patient care and lead~     to the emergence of antibiotic-resistant bacteria, one of the major threats to global health~     today. To address these challenges, MeMed has been developing the ImmunoDx™, a novel~     technology that relies on the best available detection system for differentiating between~     viruses and bacteria - the body's own immune system. The ImmunoDx™ technology employs a~     simple blood test that provides the physician, within two-hours, the information he needs to~     decide whether to treat the patient with antibiotics or not. This technology has been tested~     on over 1000 patients of different ages and diseases and was found to be highly accurate and~     safe. The current study is a non-interventional study and the participants do not receive any~     investigational drug nor any experimental examination or procedure. Therefore, the collected~     data in this study will not affect the diagnosis, prognosis, or treatment of the~     participants. Participation includes the collection of a teaspoon of blood and collection of~     a specimen using a nasal swab. These procedures are common in the clinical practice and are~     widely performed and possess no significant risk. By participating in the study, the subjects~     impact the development of the ImmunoDx™ technology, which is expected to enable a future~     faster and more accurate diagnosis of infectious diseases as well as more appropriate~     prescription of antibiotics. This will open the way to improve treatment decisions in~     millions of patients around the world.~   "
125005|NCT01931241|"~     Preclinical data support the hypothesis that the administration of AHRO-001 reduces LDL~     cholesterol levels, improves HDL function, and finally, decreases atheromatous plaque burden.~   "
125006|NCT01931228|"~     Respiratory failure after extubation is a relevant consequence of poor airway clearance due~     to respiratory muscle weakness and respiratory failure after extubation and reintubation is~     associated with increased morbidity and mortality.~      the study will evaluate the contribution of Mechanical Insufflation-Exsufflation (MI-E) in~     Preventing Respiratory Failure After Extubation as compared manually assisted coughing~   "
125007|NCT01931215|"~     Analgesia after cesarean section is still not satisfactory for many women. Even if pain~     reduction is sufficient with the technique of intrathecal morphine injection, side effects~     such as nausea and pruritus are common.~      Since several years, an alternative technique has been studied, the transversus abdominis~     plane (TAP)-block. Here a local anesthetic is injected in the abdominal wall muscles, and~     this has been shown to give a similar analgesic effect compared to intrathecal morphine, with~     potentially less side effects.~      With this study, we want to evaluate if the TAP-block yields indeed less side effects when~     compared with intrathecal morphine.~      The study will be a prospective study with the patients randomized to either a group with~     intrathecal morphine or a group with TAP-block.~   "
125018|NCT01931072|"~     The purpose of the study was to investigate whether regular moderate- or high-intensity~     interval training can change the DNA methylation in a long-lasting state, and whether these~     changes affect the gene expression. In addition, the investigators will determine whether the~     intensity of the training could be an affecting factor of the possible DNA-methylation change~     as well. The null hypothesis was that no such exercise-induced changes occur.~   "
125019|NCT01931059|"~     To detect the effect of second-generation antipsychotic drug on the neural activity.~   "
125020|NCT01931046|"~     The purpose of this study is to evaluate the safety and effectiveness of AD5-SGE-REIC/Dkk-3~     in patients with localized prostate cancer.~   "
125021|NCT01931033|"~     This study is an 8-week open-label trial testing oxytocin nasal spray (Syntocinon) as a~     treatment for social impairment in adolescents with autism spectrum disorders (ASD). We~     hypothesize that oxytocin nasal spray will be safe, tolerable, and effective in improving the~     core symptoms of autism spectrum disorders in adolescents ages 11-17.~   "
125022|NCT01931020|"~     RESEARCH HYPOTHESIS-In preterm neonates during heel lance oral 25% glucose is more~     efficacious in reducing pain as compared to oral 24% sucrose when assessed by PIPP(Premature~     infant pain profile)~   "
125008|NCT01931202|"~     This project seeks to elucidate the mechanisms by which antidepressant medications have~     limited efficacy in Late Life Depression (LLD) in order to develop new treatment~     interventions for this prevalent and disabling illness. We hypothesize that the presence of~     executive dysfunction (ED),which is common in depressed adults over 60, impairs the ability~     to form appropriate expectancies of improvement with antidepressant treatment. Greater~     expectancy has been shown to improve antidepressant treatment outcome and is hypothesized to~     be a primary mechanism of placebo effects. Moreover, white matter hyperintensities (WMH) on~     magnetic resonance imaging (MRI) are more prevalent in patients with LLD compared to healthy~     controls. It has been argued that WMH contribute to the pathogenesis of LLD with ED and~     decrease the efficacy of antidepressant medications by disrupting connections between~     prefrontal cortical (PFC) and subcortical structures. Vascular lesions to white matter tracts~     may also compromise the pathway by which expectancy-based placebo effects influence~     depressive symptoms. Expectancies reflect activation in PFC areas that may improve depressive~     symptoms by modulating the activity of subcortical regions subserving negative affective~     systems (i.e., amygdala) as well as those important in reward and hedonic capacity (nucleus~     accumbens and ventral striatum). Thus, LLD patients withED and WMH may sustain a double-hit~     to their ability to experience placebo effects in antidepressant treatments: ED diminishes~     the ability to generate appropriate treatment expectancies, while WMH disrupt the physiologic~     pathways by which expectancies lead to improvement in depressive symptoms.~   "
125009|NCT01931189|"~     The purpose of this study is to assess equivalence of pharmacokinetics between NI-071 and~     infliximab(the comparator) in Japanese healthy volunteers~   "
125010|NCT01931176|"~     Dengue viruses can cause dengue fever and other more serious illnesses. The purpose of this~     study is to evaluate the safety and immune response to a dengue virus vaccine.~   "
125011|NCT01931163|"~     RATIONALE: Everolimus plus Cisplatin may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth and by blocking blood flow to the tumor.~      PURPOSE: The purpose of this study is to test how effective combing a Cisplatin chemotherapy~     with Everolimus is in treating subjects with residual triple negative breast cancer, who have~     already received chemotherapy prior to surgery.~   "
125012|NCT01931150|"~     The purpose of this study is to see if the investigators can prevent or reduce the severity~     of the Cetuximab-related acne rash. Two different topical agents will be applied to the skin.~     One topical agent is the dapsone gel and the other is a skin moisturizer. Dapsone gel is an~     FDA approved medication that you apply to the face. It is commonly used to treat acne. Skin~     moisturizers are recommended to patients who receive Cetuximab treatment. In addition to~     these topical agents they will be given a pill to take once a day. This pill has already been~     shown to help fight rashes from Cetuximab.~   "
125013|NCT01931137|"~     This trial is conducted in Europe. The aim of the trial is to investigate the~     pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the~     effect of the investigated drug on the body) of NNC0123-0000-0338 (insulin 338) in a tablet~     formulation with three different coatings in healthy subjects.~   "
125014|NCT01931124|"~     Aim of the study is to investigate the effect of different types of training (high intensity~     and moderate training) on maximal oxygen uptake and activity levels in an elderly Norwegian~     population after one year training intervention. Baseline data include the activity levels~     assessed through self reported means as well as objectively measured activity data using~     activity monitors.~   "
125015|NCT01931111|"~     This is a substudy of the Generation-100 study (NCT01666340). The aim of this study is to~     find critical values for (1) maximal oxygen uptake and (2) sedentary behavior, below which~     cardiovascular risk parameter clustering is apparent in an elderly Norwegian population.~   "
125016|NCT01931098|"~     Background:~      Glioblastoma is the most common and most aggressive type of malignant brain tumor. The drug~     pazopanib is used to treat people with a type of kidney cancer. Topotecan is used to treat~     lung cancer. Both topotecan and pazopanib have individually been used to treat patients with~     glioblastoma and some anti-tumor activity has been found. Researchers want to see if these~     two drugs together may be able to help people with glioblastoma.~      Objectives:~      To learn if pazopanib with topotecan can help control glioblastoma. Also, to study the safety~     of this drug combination.~      Eligibility:~      Adults at least 18 years old whose glioblastoma has returned after treatment.~      Design:~      Participants will be screened with:~      Medical history~      Physical exam~      Blood and urine tests~      Brain computed tomography (CT) or magnetic resonance imaging (MRI) For these, participants~     lay in a machine that takes pictures.~      Chest CT scan or x-ray~      Heart electrocardiogram (EKG)~      A questionnaire about quality of life~      Participants will be assigned to a study group.~      Participants will take the study drugs for 28-day cycles for up to 1 year. They will take~     capsules of topotecan by mouth once every day. They will take tablets of pazopanib by mouth~     once every day.~      Participants will write in a diary the times they take the study drugs.~      Participants will have several study visits during each cycle. These may include~      Blood pressure measurement~      Blood and urine tests~      EKG~      Physical exam and/or neurological exam~      Brain MRI or CT scan to check the status of the disease~      A symptom questionnaire~      At the end of treatment, participants will have a physical exam. They may have blood drawn.~      Participants will have follow-up calls once every 3 months to check.~   "
125017|NCT01931085|"~     Triclabendazole is a benzimidazole compound used as a systemic antihelmintic in veterinary~     practice. Triclabendazole is considered to be a second-line drug for parasites and is used~     when other preferred agents cannot be used because they are ineffective or because adverse~     reactions limit their use. Although Triclabendazole is widely used in developing countries~     for the treatment of parasites it is not approved by the FDA for this treatment in the US. It~     is currently being distributed in the US through a special arrangement with the FDA and the~     manufacturer on an individual patient approval basis. This arrangement requires that a single~     patient Investigational New Drug (IND) be obtained from FDA for each patient requiring~     Triclabendazole. Upon approval by FDA, the manufacturer (Novartis) will ship the drug~     directly to the prescribing physician.~   "
125023|NCT01931007|"~     The overall goal of this study is to develop regenerative cell therapy for use in patients~     with osteoarthritis (OA). The primary objective of this proposal is to conduct a pilot study~     that assesses the safety and feasibility of using concentrated bone marrow aspirate~     containing MSC to treat patients with painful knee OA.~   "
125025|NCT01930981|"~     We are interested in studying whether and how medical problems other than primary cancer~     before hematopoietic cell transplantation would impact the profiles of quality of life and~     toxicities post-transplantation for patients with blood cancers. We want to see if by~     assessing comorbidities (such as diabetes) early on, we can identify those patients who will~     have more toxicities or limitations in their quality of life after transplant. The generated~     information could set the stage for future intervention studies aiming to improve quality of~     life for patients with blood cancers after transplantation.~   "
125026|NCT01930968|"~     The study will test the usefulness of a contrast agent to help image tumors in the eye. In~     this study, patients with eye melanoma who are going to have their eye removed, will have~     their eye imaged by ultrasound (sound waves) before and after intravenous injection of~     microbubbles. The pathology characteristics of the tumor in the removed eye will be compared~     with the images.~   "
125027|NCT01930955|"~     Some acute upper respiratory tract infection(AURI) in children is characterized by fever and~     vomiting,and it is one common reason for visiting a pediatrician. White blood count(WBC)~     usually increased in this children patients,hence antibiotics are often prescribed properly~     assumed. In the present study, it was hypothesized that it was not necessary to prescribe~     amoxicillin for the children.~   "
125028|NCT01930942|"~     The aim of this study is to find some genetic factors in predicting the sensibility of~     preoperative chemoradiotherapy for locally advanced rectal carcinoma.~   "
125029|NCT01930929|"~     The number of obese is increasing rapidly. Bariatric surgery is used to a greater and greater~     extent as treatment of obesity to obtain a greater and more permanent weight loss. The~     currently most commonly used surgical method is the gastric bypass (RYGB), which so far has~     proved to be the most effective way to achieve a greater and more permanent weight loss,~     reduction and maybe even elimination of many of the obesity-related health complication~     (diabetes, sleep apnea, pain due to osteoarthrosis etc.).~      Bariatric surgery, including RYGB is also associated with medical and nutritional~     complications. This will be a natural consequence of the fact that the food bypasses~     virtually the entire ventricle and 100-150 cm of the upper part of the small intestine after~     a RYGB. Therefore, problems with uptake of for example B12, iron, folate, thiamin,~     fat-soluble vitamins (Vitamins A, D, E and K) copper, zinc and selenium are expected. In the~     light of this, it is decided that all RYGB operated patients must take vitamin B12, iron and~     vitamin D substitution. In spite of this, many develop various nutritional problems after~     RYGB. In addition to these nutritional complications are complications such as hypoglycaemia~     and gallstone attacks after RYGB.~      Nevertheless there is no comprehensive inventory of the occurrence of nutritional~     complications after bariatric surgery neither in Denmark nor in an international context.~     Thus there is no consensus on an optimal postoperative prevention of complications. An~     overview of the occurrence of these problems will be important for assessing and determine~     the indications for bariatric surgery as well as to optimize the prevention of complications.~      To enlighten this we will conduct a cohort study of complications by investigating~     hospitalizations and deaths after RYGB. Moreover we will get an overview on medication use~     before and after RYGB operation in the Central Denmark Region and in the North Denmark Region~     2006-2011 (about 5000 patients).~   "
125030|NCT01930916|"~     Oral anticoagulants vitamin K antagonists (VKA) have been used for many years in the~     treatment of thromboembolic disorders, which are among the most costly diseases in terms of~     public health resources. According to the Agence française de sécurité sanitaire des produits~     de santé (AFSSAPS), it was estimated at about 900,000 the number of patients treated with VKA~     in 2008 (more than 1% of the French population). VKA are at the origin of many adverse~     effects, given their narrow therapeutic window. They are the cause of the death of~     approximately 5000 patients per year. The use of this therapy is a priority axis of~     reflection for the Haute Autorité de Santé.~      The interregion G4 (Nord Pas de Calais, Normandy, Picardy), with more than 9 million people,~     is particularly affected by this problem.~      University hospitals of our interregion, given their very substantial regional referral~     activity, are actually involved in managing VKA adverse side effects.~      Elderly population constitutes the majority of prescriptions. The main objective of this~     study is to compare INR of people older than 75 years measured by traditional method with~     those measured by capillary method with INRatio2 supply.~      The secondary objective is to show that this measure is not affected by the presence or~     absence of anti-phospholipid antibodies, probably very prevalent in the elderly, as well as~     to test the variability of INR measurement between different hospital.~   "
125031|NCT01930903|"~     The propose of this study is to demonstrate, whenever using Drug Eluting Stent is not~     possible, the clinical security at 12 months, of the combinaison Bare Metal Stent plus Drug~     Eluting Balloon.~   "
125032|NCT01930890|"~     The primary objective of the study is to evaluate the long-term safety and tolerability of~     BIIB023 in participants with lupus nephritis (LN).~   "
125033|NCT01930877|"~     Acute postoperative pain is an unpleasant, unwanted sensory and emotional experience for the~     patient. The investigators seek to determine if the addition of systemic lidocaine can~     improve the quality of recovery after spine surgery and reduce the requirement for opiate~     therapy.~   "
125034|NCT01930864|"~     MetIri seeks to identify if metformin combined to irinotecan can improve tumor control.~   "
125035|NCT01930851|"~     The number of obese is increasing rapidly. Bariatric surgery is used to a greater and greater~     extent as treatment of obesity to obtain a greater and more permanent weight loss. The~     currently most commonly used surgical method is the gastric bypass (RYGB), which so far has~     proved to be the most effective way to achieve a greater and more permanent weight loss,~     reduction and maybe even elimination of many of the obesity-related health complication~     (diabetes, sleep apnea, pain due to osteoarthrosis etc.).~      Bariatric surgery, including RYGB is also associated with medical and nutritional~     complications. This will be a natural consequence of the fact that the food bypasses~     virtually the entire ventricle and 100-150 cm of the upper part of the small intestine after~     a RYGB. Therefore, problems with uptake of for example B12, iron, folate, thiamin,~     fat-soluble vitamins (Vitamins A, D, E and K) copper, zinc and selenium are expected. In the~     light of this, it is decided that all RYGB operated patients must take vitamin B12, iron and~     vitamin D substitution. In spite of this, many develop various nutritional problems after~     RYGB. In addition to these nutritional complications are complications such as hypoglycaemia~     and gallstone attacks after RYGB.~      Nevertheless there is no comprehensive inventory of the occurrence of nutritional~     complications after bariatric surgery neither in Denmark nor in an international context.~     Thus there is no consensus on an optimal postoperative prevention of complications. An~     overview of the occurrence of these problems will be important for assessing and determine~     the indications for bariatric surgery as well as to optimize the prevention of complications.~      To enlighten this we will conduct a questionnaire survey of complications such as pain,~     dumping and hypoglycemia after RYGB. Moreover we will the quality of life after RYGB~     operation. We will invite 3500 RYGB operated patients the Central Denmark Region who have~     been operated 2006-2011.~   "
125047|NCT01930682|"~     The EARLY-MYO (EARLY routine catheterization after alteplase fibrinolysis vs. primary PCI in~     acute ST-segment elevation MYOcardial infarction) is an investigator-initiated, prospective,~     multicenter, randomized (1:1), open-label, actively-controlled, parallel group,~     non-inferiority trial comparing the efficacy and safety of a PhI strategy with half-dose~     fibrinolysis versus PPCI in STEMI patients presenting within 6 hours after symptom onset and~     with an expected PCI-related delay of ≥60 min.~   "
125048|NCT01930669|"~     The purpose of this study is to measure the dysfunction of the autonomic nervous system in~     modulating the heart rate variability and baroreflex control in critically ill.~   "
125036|NCT01930838|"~     The number of obese is increasing rapidly. Bariatric surgery is used to a greater and greater~     extent as treatment of obesity to obtain a greater and more permanent weight loss. The~     currently most commonly used surgical method is the gastric bypass (RYGB), which so far has~     proved to be the most effective way to achieve a greater and more permanent weight loss,~     reduction and maybe even elimination of many of the obesity-related health complication~     (diabetes, sleep apnea, pain due to osteoarthrosis etc.).~      Bariatric surgery, including RYGB is also associated with medical and nutritional~     complications. This will be a natural consequence of the fact that the food bypasses~     virtually the entire ventricle and 100-150 cm of the upper part of the small intestine after~     a RYGB. Therefore, problems with uptake of for example B12, iron, folate, thiamin,~     fat-soluble vitamins (Vitamins A, D, E and K) copper, zinc and selenium are expected. In the~     light of this, it is decided that all RYGB operated patients must take vitamin B12, iron and~     vitamin D substitution. In spite of this, many develop various nutritional problems after~     RYGB. In addition to these nutritional complications are complications such as hypoglycaemia~     and gallstone attacks after RYGB.~      Nevertheless there is no comprehensive inventory of the occurrence of nutritional~     complications after bariatric surgery neither in Denmark nor in an international context.~     Thus there is no consensus on an optimal postoperative prevention of complications. An~     overview of the occurrence of these problems will be important for assessing and determine~     the indications for bariatric surgery as well as to optimize the prevention of complications.~      To enlighten this the investigators will conduct a clinical trial concerning complications~     after RYGB. The investigators will examine 350 RYGB operated patients the Central Denmark~     Region. From a medical interview, blood tests, Dual energy X-ray absorptiometry etc. it will~     be possible to give a good estimate of the incidence of medical complications. The~     investigators will explore complications such as: anemia, hypoglycemia, peripheral nerve~     problems (especially neuropathies), vitamin D / osteoporosis and other mineral / vitamin~     deficiencies that may be identified through blood tests. A control group of 30-40 age, sex~     and body mass index matched individuals will go through the same examinations.~   "
125037|NCT01930812|"~     The purpose of this study is to compare, in patients with prostate or breast cancer, the~     accuracy of 18F-NaF PET imaging to 99mTc whole body bone scans with single-photon emission~     computed tomography (SPECT).~   "
125038|NCT01930799|"~     This study will assess the impact of a systematic bladder health screening and disease~     education regimen as well as the implementation of a referral process on the quality of life~     of multiple sclerosis patients with bladder dysfunction.~   "
125039|NCT01930786|"~     This is a registry study in adults with spasticity to determine onabotulinumtoxinA use in~     clinical practice. Treatment will be administered in accordance with physician standard~     practice. All treatment decisions lie with the physician.~   "
125040|NCT01930773|"~     Patients undergoing percutaneous coronary intervention with a residual high platelet~     reactivity despite oral clopidogrel are at increased risk of ischaemic complications. The~     strategies to overcome the issue consist of switch to a more potent antiplatelet medications~     including prasugrel or ticagrelor. Economic constrains of many countries still do not allow~     wide reimbursement of newer antiplatelet agents. Therefore a strategy to personalise~     treatment according to genotype and phenotype characteristics of the patient may provide an~     attractive solution combining high clinical efficacy with low budget impact.~   "
125041|NCT01930760|"~     The proposed study is a randomized control trial evaluating the efficacy of two training~     programs in increasing physician identification, documentation, and motivation of overweight~     children. Pediatric primary care physicians will be recruited from the College of Physician~     and Surgeons of Ontario and randomized into two practice-based interventions~     (behavioural/educational) which are a one-time training attendance. The educational~     intervention will focus on the medical management of pediatric obesity, the use of Body Mass~     Index charts, and information about how obese children would like to be approached by their~     physicians. The behavioural intervention will incorporate Motivational Interviewing tools in~     addition to an abbreviated training program received by the educational intervention group.~   "
125042|NCT01930747|"~     The objective of this study is to compare the value of deep neuromuscular block (NMB) (using~     rocuronium) in laparoscopy versus high dose opioids (using remifentanil) or 1 mean alveoalr~     concentration (MAC) inhalation (using sevoflurane) for the surgeon.~      The study hypothesis is that laparoscopic workspace is larger when using rocuronium versus~     opioids or inhalation. Laparoscopic workspace is measured as the abdominal compliance and the~     pressure at volume zero (PV0) using the abdominal pressure volume relation. Three points~     allow to calculate the abdominal compliance and the PV0.~   "
125043|NCT01930734|"~     Heart failure (HF) is a prevalent disease reaching 1-2% of adult population in developed~     countries, and 10% in patients over 70 years. In the past HF patients had a 5-year mortality~     rate of 60-70% of HF with high rate of hospitalization and disability leading to a HF~     epidemic. Treatment improvements in the past decades have significantly reduced~     hospitalization and mortality. However, there is an increasing subset of patients (>10%) with~     advanced HF symptoms (functional class III/IV) for whom current management strategies are~     limited and do not provide a significant improvement in morbidity, mortality and quality of~     life.~      Specialized HF clinics, implementing a comprehensive therapeutic approach, were suggested to~     be beneficial in this population. However, the design of these clinics is variable with~     different methods of follow-up, therapy and supervision. Intermittent infusions of dobutamine~     were previously inconclusive regarding symptom alleviation and hemodynamic improvement and~     raised a concern of increased mortality in HF patients. Furthermore, the evidence scope is~     narrow since most trials including inconsistent and relatively high dobutamine dosages.~     Accordingly, current guidelines do not provide specific recommendations for dobutamine~     therapy in stable HF patients, and indication for treatment are limited for acute HF with~     hypotension and signs of hypoperfusion, or alleviation of symptoms in severely symptomatic~     patients in stage D HF.~      The primary aim of the proposed study is to evaluate the impact of intermittent low-dose~     dobutamine infusion on clinical and hemodynamic parameters in advanced HF patients treated in~     a tertiary heart failure clinic in the setting of a randomized clinical trial. We hypothesize~     that intermittent therapy with low-dose dobutamine will be associated with improved~     functional capacity and quality of life among patients with advanced heart failure, thereby~     providing evidence for beneficial effects of a potentially important therapeutic regimen in~     this high risk population.~   "
125044|NCT01930721|"~     The angle at which an episiotomy can be made is a continuous variable. If the investigators~     consider midline to be 0 degrees and a lateral episiotomy (never used today) to be 90~     degrees, then it is theoretically possible to choose any angle from 0 to 90 degrees.~   "
125045|NCT01930708|"~     The primary objective of the study is to estimate the annualized relapse rate (ARR) in~     participants with Relapsing Remitting Multiple Sclerosis (RRMS) who are treated with dimethyl~     fumarate (DMF) over a 12-month period.~      The secondary objectives of this study in this population are to assess the impact of DMF~     over a 12-month period on participants -reported health-related quality of life (HRQoL)~     outcomes, additional clinical effectiveness outcomes, and health economics-related outcomes,~     and to characterize participants-reported adherence to DMF.~   "
125046|NCT01930695|"~     The study is designed to collect data of the performance and confirm the safety of the DX~     (Diagnostic eXtension) functionality in the Lumax 640/470 HF-T in patients with permanent~     atrial fibrillation and CRT-D indication according to current ESC guidelines. The DX~     functionality is a feature, which can be activated in the Lumax 640/740 HF-T when connected~     to the LinoxSMART S DX right ventricular lead. The combination of these devices enable atrial~     sensing via a sensing dipole in the ventricular lead and therefore reduces the number of~     implanted leads without sacrificing atrial information. Atrial pacing can not be provided but~     is not needed in patients with permanent atrial fibrillation.~   "
125049|NCT01930656|"~     Background: The Taiwanese FRAX® (Fracture Risk Assessment Tool) calculator is available~     online for clinical use. Our Taiwanese Osteoporosis Clinical Treatment Guidelines suggests~     using the American high risk cut-points for considering treatment but also suggests deriving~     domestic cut-points from cost-effective approach. Establishing cost-effective domestic~     cut-points for policy suggestions coupled with mobile devices with wireless access would~     potentially increase the usage of FRAX® tool.~      Objectives: 1) Using literature review to establish cost-effectiveness FRAX® cut-points. 2)~     To assess the effectiveness of mobile devices assisted FRAX® tool based osteoporosis~     diagnostic and management model. 3) To provide FRAX® based reimbursement policy suggestions.~      Methods: 1) Investigators will use FRAX®, cost-effectiveness and other key words to search~     Pubmed and international osteoporosis guidelines to better understand the clinical~     applications of FRAX® in other countries. Investigators will also search epidemiological data~     for osteoporosis, facture, quality of life and cost to establish domestic cost-effeteness,~     and translational approach FRAX® cut-points. 2) Three targeting populations from National~     Taiwan University Hospital (NTUH) are selected for prospective study (Group A: geriatric~     health exam clinics with American cut-points, group B: orthopedic clinics with translational~     approach cut-points and group C: endocrine clinics with cost-effectiveness cut-points,). A~     mobile device with app application coupled with the FRAX® tool is used by a trained research~     assistant during clinic waiting periods to screen and enroll high risk (75 from each clinic)~     adults with informed consents. Participants are referred to geriatric clinics for systemic~     osteoporosis diagnoses and managements. Percentage of participants that meet the current NHI~     medication reimbursement regulation and percentage of self-pay medications are calculated.~     Analysis is stratified by age and gender. 3) The impacts of 3 different cut-points on~     increment NHI reimbursement are estimated. An osteoporosis expert group meeting is to be held~     for FRAX® based osteoporosis medication reimbursement modifications to the NHI and the~     Department of Health.~      Expected Outcomes: 1) To establish the mobile device assisted FRAX® based osteoporosis~     screening and management model. 2) Base on the study results and expert consensus,~     investigators will provide policy suggestions of FRAX® based reimbursement modifications.~   "
125050|NCT01930643|"~     Background: After mechanical ventilation, 5-20% of patients with acute respiratory failure~     would depend on ventilator support more than 14 days because of critical-illness weakness and~     their underlying diseases such as heart failure and chronic obstructive pulmonary disease.~      Hypothesis: Electric muscle stimulation(EMS) will improve their muscle strength and shorten~     their ventilator days.~      Design: Randomized controlled trial. Adult patients with mechanical ventilation more than 14~     days are eligible. EMS would be applied in experimental group 32 minutes/day on their~     bilateral thigh.~   "
125051|NCT01930630|"~     By using a novel technique of extraesophageal saline injection (ESI),the esophagus is to be~     separate from the adjacent organs.The space between esophagus and adjacent organs can be~     detected by endoscopic ultrasonography enhanced with ESI.Therefore, ESI plus with EUS is to~     be differentiate between T3 and T4 stage esophageal squamous cell carcinoma (ESCC). The~     objective of this Phase Ⅰstudy is to confirm the safety and efficacy of ESI.~   "
125052|NCT01930617|"~     There are numerous reported ways to treat chronic subdural hematomas (CSDH) and practice is~     still differing considerably between departments. Except for a recent randomized controlled~     trial (RCT) that found that postoperative subdural drainage was better than no drain, there~     is no higher level evidence. Another recent RCT did not replicate these findings, but the~     study was severely underpowered.~      Aim of this population based study is to compare clinical results (reoperation rates,~     complications, perioperative death, and survival) between neurosurgical departments treating~     CSDH with different treatment policies.~   "
125053|NCT01930604|"~     Hyperhidrosis is defined as excessive sweating and affects about 2.8 % of the population.~      It has been shown to have a deleterious effect on the quality of life measured using the~     Dermatology Life Quality Index (DLQI) which is one of the most widely used~     dermatology-specific quality of life instruments. This is comparable to the effect on quality~     of life in patients with severe psoriasis of the skin as well as to nodulocystic acne~     patients before treatment with oral isotretinoin.~      The clinical effect of Botulinum Toxin (Btx) A has been established in three randomized~     controlled trials (RCT) in axillary hyperhidrosis. One RCT has indicated a positive effect in~     palmar hyperhidrosis. Although there is increasing evidence that Btx A and B have a similar~     effect on hyperhidrosis of other parts of the body (ie hyperhidrosis of the face, trunk,~     groin and feet) which is reported in case-reports and open studies there is still a great~     need for more controlled studies. This is why we will carry out this randomized,~     double-blind, placebo-controlled study to investigate the clinical effect and safety of Btx A~     in palmar, plantar and inguinal (groins/buttocks) hyperhidrosis and the clinical effect and~     safety of Btx B in craniofacial and truncal hyperhidrosis, respectively. Besides using the~     DLQI instrument we will also study Btx A/B to elucidate the impact of this treatment on~     quality of life using a generic instrument, the effect on anxiety and depressive symptoms,~     sweating, and patients´global assessment of therapy.~   "
125054|NCT01930591|"~     Ticagrelor is a first line therapy along with aspirin for patients undergoing primary PCI for~     STEMI. However, many patients are still treated with fibrinolytic therapy and the safety and~     efficacy of Ticagrelor has not been investigated in this patients population. The present~     study is proposed to study the safety and efficacy of Ticagrelor in patients undergoing PCI~     post fibrinolytic therapy for STEMI.~   "
125055|NCT01930578|"~     The objective of the study is to identify a pattern of bioimpedance in humans during acute~     food changes. As a part of this study the investigators will be administering sodium bromide~     in oder to measure extracellular water via the bromide dilution technique.~   "
125056|NCT01930565|"~     In an 8 week double blind randomized controlled split-face studies, we tried to compare the~     clinical efficacy, safety and histopathological changes between Lactobacillus fermented~     Chamaecypris obtusa (LFCO) and existing tea tree oil (TTO)~      Basically, this is a split face study - one side of face randomly assigned was applied with~     LFCO and the other side with TTO in same patients.~   "
125057|NCT01930552|"~     Primary Objective:~      To assess the safety and pharmacokinetics preliminarily of the dose of intravenous (IV)~     aflibercept used in western studies in combination with FOLFIRI (Irinotecan, 5-Fluorouracil,~     and Leucovorin) given intravenously every 2 weeks in Chinese patients with solid tumors.~      Secondary Objectives:~        -  To make a preliminary assessment of antitumor effects of the combination of FOLFIRI plus~          aflibercept in patients with measurable disease (RECIST 1.1).~        -  To evaluate the immunogenicity of IV aflibercept.~   "
125058|NCT01930539|"~     This is a randomized, controlled, unblinded pilot study for patients with vitamin D~     deficiency in Intestinal Rehabilitation clinic. These patients are not able to absorb oral~     vitamin D efficiently and thus have a high prevalence of vitamin D deficiency, leading to low~     bone density.~      The investigators will use FDA approved portable Ultraviolet B lamp for the intervention~     group, 70 patients will be recruited from October 2013 to end of January 2014 and study~     period is 12 weeks for each patient. Study completion will be end of April 2014.~      Study hypothesis: Ultraviolet B light with a portable UV device will increase Total 25~     hydroxy vitamin D level in Intestinal Rehabilitation Clinic patients.~   "
144240|NCT01679366|"~     The addition of probiotics to the routine therapy of Acute Pharyngotonsillitis in adult~     patients may shorten the duration, and reduce the severity of the disease.~   "
125059|NCT01930526|"~     Pulmonary rehabilitation (PR) with supervised exercise training is a key part of care for~     patients with chronic lung disease (COPD). Patients can improve their shortness of breath,~     walking distance and quality of life. However, many patients do not improve their overall~     fitness. They are too breathless to train at a high enough intensity. In a laboratory~     training study, patients with COPD improved their overall fitness by using single leg~     cycling. Despite this knowledge, single leg cycling has not been used clinically. The~     objective of this project is to use and assess single leg cycling in a clinical setting.~     Single leg cycling can be incorporated into a clinical service (replacing traditional two~     legged cycling) as the predominant aerobic training strategy, resulting in improvements in~     cardio-respiratory fitness (peak oxygen uptake).~   "
125060|NCT01930513|"~     Obesity is very common worldwide and breathing problems at night (obstructive sleep apnea,~     OSA) are common in obesity. Despite the best treatment, obesity and OSA are linked to early~     death from heart problems. They are also associated with lower levels of physical activity.~     Exercise strategies for weight loss, increasing physical activity and improving fitness are~     needed for obesity. In Obese individuals with OSA~        1. The investigators will compare corridor walking tests compared to laboratory exercise~          tests. The null hypothesis is that the peak oxygen uptake achieved and the~          cardiopulmonary response during both the six-minute walk test and Incremental Shuttle~          Walk Test would not be different from that observed during an Incremental Treadmill~          Test.~        2. The investigators will investigate whether cycling or walking uses more calories for the~          same intensity. We hypothesise that cycling (weight supported) will be endured for long.~        3. The investigators will compare commonly used exercise tests with levels of daily~          physical activity.~      The information from these three projects will help us set up the optimal exercise program~     for obese individuals.~   "
125061|NCT01930500|"~     The purpose of this study is to determine whether individual and/ group based~     neuropsychological rehabilitation focused on psychoeducation and teaching compensatory~     strategies has positive effects on the psychosocial wellbeing and perceived cognitive~     deficits in dyslexic young adults. The hypothesis is that both individual and group based~     neuropsychological rehabilitation show positive effects on the psychosocial wellbeing and~     perceived cognitive deficits. Another purpose of this study is to evaluate weather individual~     and group based neuropsychological rehabilitation have different kind of effects on the~     wellbeing of the participants and weather either one of the rehabilitation formats is more~     effective than the other.~   "
125062|NCT01930487|"~     The objective is to evaluate the effects of an antioxidant formula versus placebo on ocular~     blood flow in a randomized double-blind, crossover design.~      Based upon preliminary data, it is hypothesized that a dietary supplement containing a~     variety of ingredients with antioxidant properties will, compared to placebo, increase ocular~     perfusion pressure, retrobulbar, retinal capillary and choroidal blood flow, and maintain~     these effects over the course of the treatment period.~   "
125063|NCT01930474|"~     The presence of genetic alterations in the tyrosine kinase domain of the oncogene (eg. EGFR~     and ALK) is associated with the clinical response to tyrosine kinase inhibitors (TKIs) in~     patients with non-small cell lung cancers. Therefore, the detection of altered genetic~     alterations is useful for predicting the treatment response for TKIs in non-small cell lung~     cancer patients. However, good quality tumor tissues are available only in <50% of patients~     with inoperable lung cancer for mutation analysis. In this study, the investigators will~     detect and quantify the genetic alterations in plasma. the investigators will investigate if~     the serial measurement of cancer-derived genetic alterations in plasma can provide a means~     for monitoring disease progression, as well as treatment response. In addition the~     investigators will analysis the resistant mechanism of TKIs and chemotherapy with plasma~     tumor DNA.~   "
125064|NCT01930461|"~     The purpose of this study is to investigate the efficacy and safety of different doses of~     sublingual tablets of house dust mite allergen extracts as compared to placebo in adults with~     house dust mite-associated allergic asthma.~   "
125065|NCT01930448|"~     Gastric bypass (GBP) and laparoscopic adjustable banding (AGB) are common procedures that can~     result in significant weight loss and significantly improve type 2 diabetes in 40-80% of~     cases. The mechanism and time course of these changes have not been well studied and are~     poorly understood. The primary aim of this study is to investigate the potential~     weight-independent mechanisms of diabetes remission after GBP, by comparing GBP and AGB~     subjects after similar weight loss.~   "
125066|NCT01930435|"~     This is a single arm study of the use of a personalized sterile humidification device for 12~     weeks for head and neck cancer patients undergoing radiation therapy to determine if the~     usage of this humidification system will result in a decrease in severity in head and neck~     related quality of life as measured by the MDASI HN subscale following radiation therapy as~     compared with historical experience. In addition, we are exploring correlative measures using~     CRP, IL-1, IL-6, and TNF-alpha level measurements as these are directly related to mucositis~     and presumably related to quality of life as indicated by the patient.~   "
125067|NCT01930422|"~     The primary purpose of the protocol is to evaluate the effect of repeated application for 5~     consecutive days of a real tDCS compared to the application of a placebo tDCS (sham~     procedure) on the evolution of tobacco consumption in the short term between Day 1 and Day 5.~      The study hypothesis is that a repeated application for 5 consecutive days of a real tDCS on~     the left dorsolateral prefrontal cortex region will reduce the craving induced causing a~     decreased of daily tobacco consumption between Day 1 and Day 5 which can persist at the final~     visit between Day 15 and Day 20.~   "
125068|NCT01930409|"~     The purpose of this study is to determine whether is is feasible and acceptable to deliver a~     telephone based coaching intervention compared with education alone in community dwelling~     older adults (age 60 and older) after a fall related hip fracture.~   "
125069|NCT01930396|"~     The HEMO-TIN trial is designed to look at both the safety (bleeding risk) and effectiveness~     (clotting risk) of tinzaparin compared with unfractionated heparin for anticoagulation in~     hemodialysis patients.~   "
125070|NCT01930383|"~     To explore the clinical value of circulating tumor cells (CTCs) measurement for~     Hepatocellular carcinoma (HCC) patients.~   "
138368|NCT01756157|"~     The primary objectives of the study are to evaluate the safety, tolerability, and efficacy of~     two doses of CINRYZE with recombinant human hyaluronidase (rHuPH20) administered by~     subcutaneous (SC) injection to prevent angioedema attacks.~   "
125071|NCT01930370|"~     Modeling of bicarbonate within the dialysate fluid, specifically a lower than standard~     concentration has been suggested in facilitating the removal of phosphate and potassium. To~     test this hypothesis, the study will use a cross-over study design to evaluate phosphate and~     potassium removal during dialysis by altering bicarbonate concentration in dialysis fluid~     (i.e. high bicarbonate, standard bicarbonate washout, low bicarbonate), and compare the~     effects of the different dialysate bicarbonate concentrations on the removal of phosphate and~     potassium during hemodialysis~   "
125072|NCT01930357|"~     The aim of the study is to document immunogenicity and safety of VRVg in a pre-exposure~     regimen in healthy children and adolescents aged 2 to 17 years.~      Primary Objectives:~        -  To demonstrate that VRVg is non-inferior to Imovax® Rabies in terms of proportion of~          subjects achieving a rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 international~          units (IU)/mL at D42, i.e. 14 days after the last vaccination.~        -  To describe if at least 99% of subjects achieve an RVNA titer ≥ 0.5 IU/mL at D42 with a~          lower bound of the 95% confidence interval (CI) of at least 97%, in the VRVg group.~      Secondary Objectives:~        -  To assess the clinical safety of each vaccine after each vaccine injection when~          administered in a pre-exposure schedule.~        -  To describe the immune response induced by each vaccine 14 days after the last~          vaccination, i.e. at D42, and 6 months after the first vaccination~        -  To describe the geometric mean titer ratio between the two vaccine groups at D42, i.e.~          14 days after the last vaccination.~   "
125073|NCT01930344|"~     During laparoscopic surgery, your surgeon operates through 'keyhole' incisions in your~     abdomen. These allow long tools and a camera to pass to perform the surgery and allow the~     surgeon to see inside you. The cameras images are seen on a television screen, and this is~     viewed, like you watch television at home, in a two-dimensional (2D), form. This can make~     performing laparoscopic surgery very challenging, as you have to learn to appreciate depth~     while performing surgical tasks. Recent advances in viewing technology mean we now have the~     capability for comfortable three-dimensional (3D) viewing of laparoscopic surgery, and many~     centers have shown its superiority over 2D in lab-based experiments. However, this technology~     has never been compared against our normal gold standard 2D imaging in laparoscopic~     operations. This study aims to investigate whether there is a quantifiable benefit in using~     these new 3D imaging systems over 2D for laparoscopy, as we hypothesise that there is a~     marked benefit using 3D over 2D. Patients who have been placed on the waiting list for~     keyhole surgery to remove their gallbladder will be invited to take part in the study. If~     they agree, they will undergo the standard operation for removing their gallbladder as~     planned already. At the beginning of the operation they will be randomised (selected by~     chance) into one of two groups. One group will have their surgery performed to our current~     'Gold standard' with the surgeon using a 2D camera and screen. The other group will have the~     exact same operation but with the surgeon using a 3D camera and screen. The intra-abdominal~     part of the operation will be recorded and viewed by an independent observer who is a~     surgeon, to assess for technical performance differences between operations performed in 2D~     and 3D, as well as time taken for the surgery. There are no extra risks to taking part and~     being randomised to the 3D group. The laparoscopic camera is the same size as a 2D camera and~     used in the same way. There are no real disadvantages, as patients will still undergo the~     operation they were booked for and will experience no change in their treatment. The aim is~     to compare 2D and 3D Day Case Laparoscopic Cholecystectomies, to see if there is a marked~     difference with this new technology. Lab based studies imply that 3D imaging systems reduce~     surgical errors and operating time therefore could improve patient safety. This study may~     help improve laparoscopic surgery for future patients.~   "
125074|NCT01930331|"~     Phase IV, single center, 2 arms randomized controlled, open label study. Study will be~     conducted over a period of 42 days to determine the safety, tolerability, pharmacokinetics~     and efficacy of ARCO.~   "
125075|NCT01930318|"~     It is well established that the resistance to the effects of insulin on glucose metabolism~     develops with a lot of stress hormone release after surgical trauma. This condition is known~     as insulin resistance (IR) characterized by hyperglycemia, hyperinsulinemia and lactic~     acidosis. Surgical IR not only affect glucose metabolism but also influence protein~     synthesis, then further exacerbate the depletion of the carbohydrate, fat and protein.~      Postoperative pain is a challenging task for patients and surgeons, and it is part of the~     stress response to trauma and surgery, while the fear of pain can exacerbate the stress~     response.~      The main aim of this study was to invest whether effective postoperative analgesia can reduce~     the stress response and insulin resistance.~   "
125076|NCT01930305|"~     To inversitage whether routine warming of blood is harmful to brain fuction of sugical~     patients receiving massive transfusion.~   "
125077|NCT01930292|"~     This is a two-part trial in patients with squamous non-small cell lung cancer (NSCLC),~     platinum (Pt)-refractory ovarian cancer, and basal-like/claudin low triple negative breast~     cancer (TNBC).~      The primary objective of Part A is to determine the maximum tolerated dose (MTD) of Debio~     1143 when administered to these patients in combination with full doses of paclitaxel and~     carboplatin.~      The primary objective of Part B is to consolidate the safety profile of the recommended dose~     of Debio 1143 when administered to these patients in combination with full doses of~     paclitaxel and carboplatin.~   "
125078|NCT01930279|"~     Sleep deprivation was found to affect many organs including the immune system and~     predisposing for various health consequences including diabetes hypertension infections and~     increase in neoplastic diseases.~      Subjects will be evaluated for immune parameters in peripheral blood test following a regular~     nigh sleep and compared with a test performed following a night shift in which they slept~     less than 3 hours.~      Each participant will serve as its own control.~   "
125079|NCT01930266|"~     Diet is the only source for calcium and the most important dietary source are dairy products.~     This presents a difficulty for children with IgE-mediated cow's milk allergy, who are unable~     to consume milk. We noted that IgE-CMA allergic young adults have a significant decrease in~     bone mineral density (BMD) compared to international reference values and also to~     geographically and age matched normal controls.~      Working hypothesis: Young adults with IgE-CMA have significantly lower BMD than age and~     gender matched controls. This can be reversed by introducing dairy products following~     recovery from allergy, or by enriching the diet via other calcium sources.~   "
125120|NCT01929733|"~     Percutaneous closure is one of the methods used to treat, among other congenital heart~     disorder, Persistent Ductus Arteriosus (PDA) in children and adults. During the years~     1998-2013 four hundred and fifty patients were catheterized in the department of pediatric~     cardiology and congenital heart diseases in Rambam health care campus, using various devices.~      In this retrospective research, the investigators analyze data from patients' medical files,~     to estimate and define the correlation between the patients' demographic and morphologic data~     to the type and size of chosen closure device.~      Aim of study:~      To create an algorithm that can be used to choose the proper device for percutaneous closure~     of the PDA, based on the characteristics of the patient and the PDA type.~   "
138451|NCT01755065|"~     The purpose of this study is to find a more accurate postoperative pain assessment for~     teenager patients. This is important because a patient should not have a very strong pain~     medication such as morphine if the pain is just mild.~   "
125080|NCT01930253|"~     Autoimmune cytopenias are a significant complication observed after hematopoietic cell~     transplant (HCT) and carries a substantial rate of morbidity and mortality. This entity is~     usually challenging to treat, resulting in prolonged hospitalization and predisposes patients~     to complications either directly due to the specific cytopenia or due to the immune~     suppression that is part of its therapeutic management. One of the mediators of refractory~     autoimmune cytopenias are antibodies produced by plasma cells, which are historically~     challenging to target. The purpose of this study is to use a proteasome inhibitor called~     Bortezomib for the treatment of refractory autoimmune cytopenias after HCT, and monitor the~     clinical response.~      This is a pilot study which will enroll 5 patients over 2 years, prospectively. Our~     hypothesis is that bortezomib will effectively target plasma cells and successfully treat~     refractory autoimmune cytopenias. This will be a relevant study as it will be the first step~     in establishing a novel therapeutic modality and potentially reducing length of~     hospitalization and degree of immune suppression for refractory autoimmune cytopenias.~   "
125081|NCT01930240|"~     The primary objective of the study is to assess the blood profile of the N-methylnicotinamide~     (MNA) following administration of TRIA-662 (N-methylnicotinamide Chloride). The secondary~     objectives of the study are to characterize the safety and tolerability of TRIA-662 and to~     assess any potential gender-related differences in the plasma profile of MNA. Changes in~     serum lipid parameters with particular reference to triglycerides, lipoprotein lipase, and~     blood pressure effects will also be noted.~   "
125082|NCT01930227|"~     The purpose of this study is to compare the effect of TEAS on hypotension after spinal~     anesthesia in patients undergoing cesarean section~   "
125083|NCT01930214|"~     The objective of this study is to assess the current standard of care treatment outcome in~     none/mild, moderate and severely calcified coronary lesions using:~        -  A composite of MACE at 30-day and one (1) year post procedure, and~        -  Procedural and lesion success~   "
125084|NCT01930201|"~     This retrospective chart review will demonstrate the feasibility of performing caudal~     epidural blockade in adolescents undergoing major orthopedic hip surgery and provide~     information regarding the feasibility of this technique's use on a regular basis.~   "
125085|NCT01930188|"~     This trial is conducted in Africa, Asia, Europe and South America. The aim of the trial is to~     evaluate efficacy and safety of semaglutide once-weekly versus sitagliptin once-daily as~     add-on to metformin and/or TZD (thiazolidinedione) in subjects with type 2 diabetes.~   "
125086|NCT01930175|"~     To evaluate the safety, tolerability and efficacy of a single intravneous infusion of VAY736,~     compared to placebo, in pemphigus vulgaris patients.~   "
125087|NCT01930162|"~     This study was designed to evaluate the safety and tolerability of HSC835 for clinical use as~     measured by the absence of graft failure at day 42 in excess of that currently observed with~     double umbilical cord blood (UCB) transplantation (DUCBT) with non-myeloablative (NMA)~     conditioning.~   "
125088|NCT01930149|"~     Cholesterol screening is an important prerequisite for cardiovascular disease (CVD) risk~     assessment. Cholesterol screening is recommended by the United States Preventive Services~     Task Force (USPSTF). Since reminder systems have been shown to modestly improve the rates of~     preventive services, including in safety net settings, we will implement patient-directed~     reminders to health center patients who meet our eligibility criteria.~      The aim of this study is to determine if a mailed outreach message and facilitated ordering~     of screening lipid tests increases cholesterol screening test completion within 3 months~     among federally qualified community health center patients who are eligible for screening~     compared to usual care.~   "
125089|NCT01930136|"~     The study investigates whether a long-term 25% caloric restriction can prevent onset and/or~     progression of renal function deterioration, retinal involvement and cardiovascular~     complications in overweight/obese type 2 diabetic patients, trough the amelioration of~     concomitant metabolic abnormalities such as visceral obesity, insulin resistance,~     dyslipidemia, hypertension and inflammation.~      The main aim of the study is therefore to evaluate the role of calorie restriction (CR) on~     subjects at risk of nephropathy. Secondary aims are to better understand the relationship~     between CR and the following aspects: renal disease and its associated metabolic~     abnormalities, retinopathy and cardiovascular complications, quality of life and treatment~     cost.~   "
125090|NCT01930123|"~     This study will advance several goals of the NIH Action Plan: 1) establish a~     multidisciplinary team to develop quantitative methodologies and imaging protocols for liver,~     2) validate diagnostic criteria and methodologies for imaging in liver in both a~     cross-sectional and a longitudinal dietary intervention study of patients with NAFLD, 3)~     create a liver tissue bank with correlative imaging data, 4) develop reliable non-invasive MR~     markers to distinguish simple steatosis from NASH, and 5) define the dynamic changes in~     metabolism, energy homeostasis, and MR biomarkers as they relate to fructose-related liver~     injury.~   "
125091|NCT01930110|"~     Closed-loop strategy is composed of three components: glucose sensor to read glucose levels,~     insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required~     insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would~     regulate glucose levels through the infusion of two hormones: insulin and glucagon.~      The objective is to compare the efficacy of single-hormone closed-loop strategy and~     dual-hormone closed-loop strategy at regulating glucose levels during continuous exercise and~     interval exercise.~      The investigator hypothesized that dual-hormone closed-loop strategy is superior to~     single-hormone closed-loop strategy in regulating glucose levels during exercise periods.~   "
125121|NCT01929720|"~     This randomized clinical trial studies a cognitive-behavioral intervention to treat worry,~     uncertainty, and insomnia in cancer survivors. Counseling may reduce anxiety and insomnia as~     well as improve the well-being and quality of life of cancer survivors. This study also~     explores the neuro-immunologic correlates of anxiety and insomnia.~   "
125122|NCT01929707|"~     The main purpose of this study is to evaluate the safety and how well the body will handle a~     single dose of increasing strength of study drug LY3050258. Each participant will receive~     LY3050258 or placebo once, in each of two dosing periods. At least seven days will pass~     between doses. This study will last approximately 45 days for each participant. Screening is~     required within 28 days before the start of the study.~   "
125092|NCT01930097|"~     Closed-loop strategy is composed of three components: glucose sensor to read glucose levels,~     insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required~     insulin dosage based on the sensor's readings. A dual-hormone closed-loop system would~     regulate glucose levels through the infusion of two hormones: insulin and glucagon.~      The objective of this project is to assess whether a dual-hormone closed-loop strategy would~     alleviate the burden of carbohydrate counting from patients with type 1 diabetes (T1D)~     without a significant degradation in post-meal glucose control.~      Our primary hypothesis is that meal-announcement strategy (pre-meal CHO-independent bolus) is~     equivalent to meal-and-carbohydrate-announcement strategy (full CHO-matching bolus) during~     closed-loop regulation of glucose levels in adults with T1D. Our secondary hypothesis is that~     closed-loop strategy with meal-announcement strategy (pre-meal CHO-independent bolus) or~     meal-and-carbohydrate-announcement strategy (full CHO-matching bolus) is better than~     conventional pump treatment in regulation of glucose levels in adults with T1D.~   "
125093|NCT01930084|"~     Purpose: To compare the effectiveness of a combination intervention strategy (CIS),~     consisting of point of care (POC) CD4+ testing immediately following HIV diagnosis and~     accelerated ART initiation for eligible participants delivered by facility personnel, and~     cellular appointment reminders delivered by study personnel, to the standard of care (SOC) on~     linkage to and retention in HIV care at 12 months among adults testing positive for HIV in~     Mozambique. Additionally, the protocol will assess the incremental effectiveness of CIS+~     non-cash financial incentives (FI) compared to CIS without FI on study outcomes.~   "
125094|NCT01930071|"~     To assess the safety of performing a percutaneous fem-pop bypass using the PQ Bypass~     Guidewire Delivery System and commercially available stent grafts.~   "
125095|NCT01930058|"~     This adaptive design study will evaluate the safety, pharmacokinetics, and effect on~     hepatitis C virus (HCV) RNA levels of multiple doses of MK-8876 in participants with HCV~     infection. The study will consist of 4 parts evaluating participants infected with specific~     hepatitis C virus genotypes and up to 10 panels allowing for additional participants to~     enroll in each panel as specified in the study analysis. The hypothesis evaluated in the~     study is that a ≥2.5 log IU/mL reduction in HCV RNA from Baseline will accompany multiple~     dose administration of MK-8876 in participants with HCV infection.~   "
125096|NCT01930045|"~     This study evaluated the effect of single doses of a magnesium/aluminum antacid (MAALOX)~     given 4 and 6 hours before or after administration of raltegravir, on the pharmacokinetics of~     raltegravir in human immunodeficiency virus (HIV)-infected participants. The study consisted~     of Part 1 (Periods 1, 2, and 3) and Part 2 (Periods 4 and 5), with each study period~     separated by a washout period of at least 2 days; Part 1 was separated from Part 2 by a~     Pause. Each study period had a duration of ≥2 days, and paused for evaluation of Part 1~     pharmacokinetics results before continuing to Part 2. The same participants participated in~     Parts 1 and 2. The primary hypothesis tested (in Part 1) was that raltegravir plasma~     concentration 12 hours after administration (C 12 hrs) would not differ significantly from~     raltegravir C 12 hrs when antacid is administered 4 hours before or 4 hours after~     raltegravir.~   "
125097|NCT01930032|"~     The purpose of this study is to learn more about infection by Clostridium difficile (also~     known as C. difficile). C. difficile is a common bacterium (a germ that may cause disease)~     that can live in the human gut. Some people have it without having any symptoms. In other~     people it can cause illness ranging from mild diarrhea to severe colitis (infection of the~     colon).~      C. difficile makes toxins that damage the cells that line the colon. The study doctors want~     to find out how these toxins cause damage to the cells in the colon.~   "
125098|NCT01930019|"~     The effect of etomidate administration on the adrenal cortex in obese patients is still~     unclear. The objective of the study was to determine the influence of single dose of~     etomidate on cortisol secretion in morbidly obese. The participants were divided equally into~     etomidate and thiopental groups, depending on kind of intravenous anesthetic used for~     induction of anesthesia.~      Healthy patients in ASA class I and II awaiting elective abdominal laparoscopic surgery were~     included in the study. The participants were initially divided into two groups: the first~     group included patients with morbid obesity (BMI > 40), and the second group included~     patients with normal body weight (BMI < 25). All the patients inside the two groups were~     subsequently randomly and divided into etomidate and thiopental groups, according to the~     intravenous anesthetic used as the induction agent for general anesthesia. Finally, four~     groups of patients were analyzed: 1. obese, in which etomidate was used (OE group), 2. obese,~     in which thiopental was used (OT group), 3. patients with normal body mass, in which~     etomidate was used (NE group), and 4. patients with normal body mass, in which thiopental was~     used (NT group).~      The patients excluded from the study were those who: 1. did not agree to participate, 2. were~     treated with steroidal drugs, 3. had cortisol metabolism disorders or were treated with drugs~     with a potential impact on serum cortisol concentration, 4. had a preoperative risk~     assessment result of ASA class III, IV and V, 5. had an initial surgical laparoscopic~     technique converted to laparotomy, and 6. had surgical complications increasing the level of~     intraoperative stress.~   "
125099|NCT01930006|"~     In this study two MGCD265 oral formulations at dose level of 100 mg are administered to~     healthy male and female subjects under fasting conditions.~   "
125100|NCT01929993|"~     The purpose of this trial is to evaluate if Straight Wire Excision of the Transformation Zone~     (SWETZ) is superior to (Large Loop Excision of the Transformation Zone) LLETZ cone in~     reducing the incomplete excision of disease.~   "
125101|NCT01929980|"~     The purpose of this trial is to study the safety and effectiveness of a drug called~     Bortezomib for the treatment of low blood cell counts after bone marrow transplant.~   "
125123|NCT01929694|"~     Consuming a guaraná and vitamin and mineral complex can improve mental fatigue and cognitive~     function at rest; guaraná also contains caffeine, which can reduce perceived exertion and~     increase fat burning during exercise. The purpose of this study is to test whether consuming~     a guaraná and vitamin and mineral product before exercise influences affect (mood), physical~     exertion and fat burning during exercise and mental fatigue, cognitive performance and affect~     post-exercise.~   "
125609|NCT01923337|"~     This phase I trial studies the side effects and best dose of alisertib when given together~     with irinotecan hydrochloride in treating patients with advanced solid tumors or colorectal~     cancer. Irinotecan hydrochloride and alisertib may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth.~   "
125102|NCT01929967|"~     The investigators aim with this study is to investigate the mechanisms of immune deficiency~     in patients with heterotaxy syndrome through the use of novel biomarkers and a prospective~     questionnaire survey documenting the burden of infectious sequelae following enrollment. It~     is known that patients with under-active spleens (functional asplenia or hyposplenia)~     secondary to other (non-cardiac) conditions such as Sickle Cell Disease or Inflammatory Bowel~     Disease have a characteristic paucity of a B cell sub-class known as IgM memory B cell. This~     specific sub-class of B cell normally matures in the spleen and in those with an improperly~     functioning spleen a significant deficiency of this B cell class is seen on flow cytometry.~      Similarly, these same patients are noted to have increased amounts of 'junk' DNA / nuclear~     remnant in their red cells. This is seen on microscopy as a dark particle inside the red cell~     and is termed a Howell Jolly Body (normally less than 2% of red cells have these dark~     particles present). Part of a functioning spleen's normal task is to rid the blood of red~     cells that contain nuclear remnants and an under-active spleen gets behind on this task with~     a build-up of Howell Jolly Bodies in red cells present in the bloodstream. Flow cytometry can~     very quickly and accurately quantify Howell Jolly Bodies as well as IgM memory B cells from a~     small (~1.5cc) sample of blood. Normal IgM memory B cell ranges are known for healthy~     children from infancy onwards allowing interpretation of results against normative data~     ranges.~      The investigators aim to enroll 10 patients in this pilot study who have a diagnosis of~     heterotaxy syndrome (both asplenia and polysplenia) and to prospectively follow them after~     obtaining the initial biomarker sample. The family will be contacted once every two weeks for~     a period of 12 weeks and asked a series of simple questions taking approximately 5 minutes on~     any recent infectious sequelae or symptoms. The questions will elucidate history of minor~     illness such as low-grade fever or cough to more significant events such as admission for~     in-patient antibiotic therapy of bacterial sepsis. Ultimately, with this pilot study, the~     investigators hope to obtain sufficient data to support funding applications for a larger,~     multi-center trial that will allow us to develop biomarker thresholds for future risk of~     sepsis.~   "
125103|NCT01929954|"~     This is a prospective, randomized, controlled, parallel group Phase 1/2 assessment of the~     safety of GINTUIT versus Bio-Gide in subjects who have a posterior tooth requiring~     extraction. The incidence and severity of adverse events will be summarized by group (GINTUIT~     and Bio-Gide).~   "
125104|NCT01929941|"~     This is an open-label study of INCB047986 given to two distinct groups of patients (Group 1~     and Group 2) with advanced malignancies. The purpose of the study is to evaluate the safety,~     tolerability and pharmacokinetics of INCB047986 and to determine the maximum tolerated dose~     of INCB047986 in combination with gemcitabine and nab paclitaxel in a select group of~     patients with solid tumors. Each patient group will participate in a phase of the study which~     is divided into two parts. The patient groups will be enrolled in a sequential manner~     starting with Patient Group 1.~      Patient Group 1~      Group 1 will be comprised of patients with advanced malignancies who will receive INCB047986~     as monotherapy.~      Part 1: Dose Escalation Phase - This phase will evaluate the safety, tolerability and~     pharmacokinetics (PK) of INCB047986 when given as described to patients with advanced~     malignancies. A goal of Part 1 will be to identify the maximally tolerated dose (MTD) of~     INCB047986 and/or other dose(s) that are tolerated doses and produce a substantial~     pharmacologic effect. These doses will be used in Part 2 of the study.~      Part 2: Expansion Phase - This phase will further explore the safety, tolerability, PK, and~     preliminary clinical activity of INCB047986 using the doses identified in Part 1.~      Group 2~      Group 2 will be in subjects with advanced or metastatic pancreatic cancer, breast cancer or~     urothelial cancer.~      Part 1: Dose Optimization Phase - This phase will identify the MTD of INCB047986 in~     combination with gemcitabine and nab-paclitaxel in patients with advanced or metastatic solid~     tumors. Specifically, these will be patients with pancreatic adenocarcinoma (first or second~     line), triple-negative breast cancer (second line) or urothelial cancer (second line).~      Part 2: Expansion Phase - This phase will explore the safety, tolerability, PK, biomarkers,~     and preliminary clinical activity of the dose regimen(s) identified in Part 1. Patients~     enrolled in this phase will be limited to those with advanced or metastatic pancreatic~     cancer.~   "
125105|NCT01929928|"~     The purpose of this study is to test the efficacy of a new cordless ultrasonic dissection~     system.~   "
125106|NCT01929915|"~     Long-term survival for patients with pancreatic carcinoma is low, even following resection,~     the 5-year survival rate of patients ranges from 10 to 25%1. Most treatment failure is due to~     local recurrence, distant metastasis or both within one to two years after surgery2-4.~      Surgery has been suggested to accelerate the development of preexisting micro metastases and~     to promote the establishment of new metastases5. Release of catecholamine and proinflammatory~     products secondary to surgical stress is believed to promote cancer progression6. Maintenance~     of proper anesthetic depth is beneficial to attenuate surgical stress. However, general~     anesthesia including numerous induction agents, volatile anesthetics and opioids, is~     associated with immunosuppression especially on the cell-mediated immunity which has a~     crucial role in prevention of micrometastasis5,7. Therefore, regional anesthesia and~     analgesia which effectively attenuating surgical stress while efficiently reducing general~     anesthetics consumption, seem to provide promising advantages to prevent perioperative cancer~     progression. Currently, most studies available in humans are retrospective and observational~     to evaluate regional anesthesia and prostate, colorectal, breast and cervical cancer-related~     outcomes8-12. Only one randomized study investigating major abdominal cancer surgery is~     available13. However, it is not specific to an individual cancer type and perioperative~     cell-mediated immunity is not evaluated.~      In this study, we aimed to identify whether epidural block beneficial to early surgical and~     late cancer-related outcomes in patients receiving pancreatic cancer surgery. Perioperative~     cell-mediated immunity functions including natural killer cells, helper and cytotoxic~     T-lymphocytes were also investigated.~   "
125107|NCT01929902|"~     The purpose of this study is to test the efficacy and accuracy of the Aquamantys device.~   "
125108|NCT01929889|"~     The study looks at whether treatment with iloperidone (Fanapt) is associated with~     improvements in social cognition in individuals who have been recently diagnosed with~     schizophrenia or schizoaffective disorder. Social cognition (the ability to understand your~     feelings and the feelings of others) is closely related to functional outcomes, including~     communication, empathy, and emotional recognition.~   "
125109|NCT01929876|"~     This open-label, 2-period, fixed sequence, drug interaction study will investigate the effect~     of co-administration of itraconazole on the pharmacokinetics of cobimetinib in healthy~     participants. Participants will receive multiple repeating doses of cobimetinib and~     itraconazole.~   "
125110|NCT01929863|"~     Metformin may have complex interactions in the gut and is generally first line therapy for~     type 2 diabetes mellitus (T2DM). It is important to understand whether there are significant~     pharmacokinetic or pharmacodynamic interactions when GSK2330672 is co-administered with~     metformin in subjects with T2DM. The purpose of this study is to investigate the safety and~     tolerability of GSK2330672 administered for 7 days to subjects with T2DM taking metformin.~     This will be a two-period crossover study; subjects will receive either GSK2330672 or placebo~     for 7 days in each period separated by a washout period of 13 to 15 days. All subjects will~     receive metformin throughout the study~   "
125124|NCT01929681|"~     Objectives:~      To demonstrate the duration of the antidepressant effect of Low Field Magnetic Stimulation~     (LFMS)in subjects with bipolar depression.~      Hypotheses:~      Investigators expect subjects who receive LFMS to show significant mood improvement one week~     after the start of a three day course of daily stimulation as compared to subjects who~     receive sham LFMS.~      Investigators expect subjects who receive LFMS to show immediate mood improvement over the~     first treatment as measured by the difference in pre and post-treatment PANAS+ ratings.~      Investigators expect to show that LFMS will be well tolerated in a three-treatment protocol.~   "
125111|NCT01929850|"~     Obesity is a costly multi-etiology world disease of fat storage. Morbid obesity is defines as~     greater than 100 pounds overweight and/or greater than 200 % of ideal body weight. Chronic~     underemployment, poor housing, child abuse, limited education, stress and anxiety are all~     associated with maternal morbid obesity. These latter conditions leave many patients in a~     state of economic, social and emotional poverty with need for life-long welfare support. For~     patients with true morbid obesity a standard surgical procedure is currently the procedure of~     choice especially among patients who fail standard medical intervention. The major procedures~     performed for morbid obesity include the Roux-en-Y gastric bypass, sleeve gastrectomy and~     laparoscopic band procedure. The sleeve gastrectomy is purely a restrictive procedure without~     malabsorptive components which involves one single staple line and can be performed~     laparoscopically in less than one hour. While these surgical procedures are recognized as~     standard procedures for patient who have failed medical treatment and are covered by most~     health plans, access to these procedures is limited for the medically underserved, rural,~     poor or underrepresented minorities since national, state and municipal health plans either~     provide minimal coverage or no coverage at all for surgery for morbid obesity. Reimbursement~     to providers offering these procedures is minimal and thus access to bariatric surgery is~     unlikely within a timely fashion.~   "
125112|NCT01929837|"~     Tinnitus is the perception of sound in the absence of corresponding external sound. Tinnitus~     affects approximately 10-15 % of the population. The prevalence increases with age and it is~     estimated that more than 20 % of the older people have tinnitus. Approximately 10-15 % of~     tinnitus patients have clinically relevant, disabling tinnitus causing for example anxiety,~     depression and sleep disturbances. The treatment of chronic tinnitus is difficult and most~     therapies focus on alleviating the condition rather than treating the cause. Pathophysiology~     of tinnitus still remains incompletely understood. Functional brain imaging data in tinnitus~     patients and animal models suggest that tinnitus is associated with increased neuronal~     activity, increased synchronicity, and functional reorganization within the auditory cortex~     either uni- or bilaterally, but there are also functional alterations in brain areas outside~     the auditory system. Transcranial magnetic stimulation (TMS) is a neuromodulation technique~     based on the principle of electromagnetic induction of an electric field in the brain by~     means of magnetic pulses given to the scalp. TMS is a non-invasive, painless, and safe method~     for modulation of cortical activity. TMS pulses given at low frequencies (≤ 1 Hz) have been~     shown to decrease cortical excitability both in experimental settings and humans, which forms~     the basis for using low frequency rTMS to treat chronic tinnitus patients, in whom~     hyperactivity of the auditory cortex has been observed in functional brain imaging studies~   "
125113|NCT01929824|"~     This study is aimed at understanding whether oral nitric oxide levels can be used as a~     non-invasive marker for the diagnosis and management of patient with eosinophilic esophagitis~     (EoE).~   "
125114|NCT01929811|"~     To evaluate docetaxel, epirubicin and cyclophosphomide (TEC) with TEC plus metformin in~     neoadjuvant treatment of breast cancer patients. The aim is to evaluate whether metformin can~     increase the pCR rate combination with TEC regimen in neoadjuvant setting.~   "
125115|NCT01929798|"~     The purpose of this trial is to assess the performance of an Artificial Pancreas (AP) device~     using the Portable Artificial Pancreas System (pAPS) platform for subjects with type 1~     diabetes using an insulin pump and rapid acting insulin. This proposed study is designed to~     compare closed-loop control with or without optimization of initialization parameters related~     to basal insulin infusion rates and insulin to carbohydrate (I:C) ratios for meals and~     snacks.~   "
125116|NCT01929785|"~     This is a single center observational study. Duration of the study is 1 year. Participants~     will be followed in 2 groups. Group 1 will include all patients who have undergone a heart~     transplant, through the first year post transplant. Group 2 will include heart transplant~     recipients from 1 year to 2 years post transplant. Groups will be enrolled simultaneously. It~     is anticipated each group will have 25 participants.~   "
125117|NCT01929772|"~     The aim of this study is to investigate if there is a correlation between lactate clearance~     and the course at patients with severe sepsis and septic shock at german intensive care~     units.~   "
125118|NCT01929759|"~     In this study we will use a multi-modal imaging approach of MRS and fMRI to comprehensively~     assess the biological changes in the brain associated with EFV-based regimen (EFV/FTC/TDF),~     specifically alterations in the brain circuitry, function and local neurochemistry, and their~     correlation with neuropsychological function. In a cohort of HIV-infected patients who are~     clinically stable on the commonly use regimen of EFV/emtricitabine (FTC)/truvada (TDF) or~     Atripla, we propose to replace the EFV component with a new integrase inhibitor, elvitegravir~     (EVG) boosted with cobicistat (COBI), given as the EVG/COBI/FTC/TDF Single Tablet Regimen~     (STR) to evaluate the EFV-related neural alterations. This is a multidisciplinary study which~     involves a team of infectious disease experts in the field of HIV, neuroradiologists with~     expertise in fMRI and MRS techniques to study various central nervous system and psychiatric~     disorders and a psychiatrist with experience and expertise in research on abnormalities of~     affective and motivational processing in the context of neuropsychiatric disorders. We will~     utilize the established clinical research platform in the Infectious Disease outpatient~     clinical practice at the Brigham and Women's Hospital, where there is currently have many~     ongoing HIV-related studies and a large panel of HIV-infected patients motivated to be~     involved in clinically relevant research. We propose to use advanced neuroimaging to measure~     biologically changes in the brain associated with long-term EFV use with the following~     specific aims:~        1. Determine changes in neurometabolites measured by MRS in the brain associated with~          long-term EFV use~        2. Assess for alterations in neural activity correlated with affective symptoms associated~          with EFV vs STR use using fMRI, and their associations with changes in neurometabolites~          assessed by MRS, and with changes in cognition assessed by Trail Making and Digit~          Substitution Tests.~        3. Determine changes in emotion, cognition and sleep quality after switching from EFV to~          STR, and how they correlate with subject treatment preference.~      This clinical study will extend our current understanding of EFV neurotoxicity by further~     defining the nature of these biological changes. Further elucidation of the neurobiological~     underpinnings of EFV-induced CNS toxicity will have clinical relevance in improving the~     quality of life and drug adherence of HIV-infected patients on ART, especially among older~     patients or those with baseline neuropsychiatric disorders, whom at baseline are more~     vulnerable to neurocognitive decline from long-term HIV infection.~   "
125119|NCT01929746|"~     The primary objective of the study is to evaluate the pharmacokinetic (PK) profile of BIIB019~     (Daclizumab High Yield Process; DAC HYP) administered as a single subcutaneous (SC) dose (75~     mg or 150 mg) Japanese and Caucasian adult healthy volunteers. The secondary objective of~     this study in this study population is to assess the safety and tolerability of BIIB019~     administered as a single SC dose (75 mg or 150 mg).~   "
125125|NCT01929668|"~     The purpose of this study is to compare preference of the patients, efficacy of preparation,~     and safety between 4 L polyethylene glycol and 2 L of polyethylene glycol with ascorbic acid~     in patients with inactive ulcerative colitis.~   "
125126|NCT01929655|"~     To evaluate the efficacy and safety of the best standard of care plus BAY88-8223 in Japanese~     patients with CRPC and bone metastases after a multiple administration~   "
125127|NCT01929642|"~     The purpose of this study is to assess the feasibility and safety of administering~     rapalogues, sirolimus or everolimus, in participants with Tuberous Sclerosis Complex (TSC)~     and self-injury and to measure cognitive and behavioral changes, including reduction in~     autistic symptoms, self-injurious and aggressive behaviors, as well as improvements in~     cognition across multiple domains of cognitive function.~   "
125128|NCT01929629|"~     The purpose of this study is to assess the safety and tolerability of orally administered~     AZD0914 in healthy adult subjects.~   "
125129|NCT01929616|"~     The general objectives are to evaluate activity and the safety of regorafenib in a population~     of patients bearing advanced, refractory colorectal cancers and to explore the different~     downstream molecular pathways to identify tumor response and resistance mechanisms.~   "
125130|NCT01929603|"~     This is a 2-part study in patients with advanced solid tumours. Part A will investigate the~     effect of rifampicin on the PK parameters of olaparib in patients; Part B will allow patients~     continued access to olaparib after the PK phase and will provide additional safety data.~   "
125131|NCT01929590|"~     the efficacy and tolerability of a low-volume (2 L) PEG regimen for colonoscopy compared to~     single (4 L) or split-dose (2 L + 2 L) treatments are not different.~   "
125132|NCT01929577|"~     The purpose of this study is to determine the relative bioavailability of ASP015K under~     fasting conditions after single-dose administration between a test-tablet formulation and a~     reference-tablet formulation. This study will also evaluate the food effect on~     bioavailability of the test formulation, and evaluate the safety and tolerability after~     single-dose administration of the test- and reference-tablet formulations.~   "
125133|NCT01929564|"~     The participants of this study will be men & women ≥50 years who are deemed to have a 10-30%~     risk of developing CVD over the next 10 years. Their risk will be calculated using the Joint~     British Societies 2 (JBS2) guidelines on the prevention of CVD in clinical practise~     algorithm. This takes into account the participants age, sex, cholesterol values, blood~     pressure,family history and their ethnicity (SE Asian or not). The participants will be~     randomly assigned to one of two groups with the aid of a computer program called minim~     which uses their age, sex, BMI and smoking status to determine which broccoli each~     participant will consume on the intervention.~      Each participant will consume 4 x 100g of their assigned broccoli, each week for 12 weeks on~     top of their normal diet. They will be allowed to eat the broccoli whenever they want during~     the week, but will be asked to note down when they eat it. A steamer will be provided so~     participants can cook their broccoli for the required 4-5 minutes. Participants will be asked~     to keep two diet diaries during their time on the intervention, one before they start the~     intervention and one towards the end. Blood samples and urine will also be collected, pre and~     post intervention, for the analysis of biomarkers of CVD.~      This is joint project based at two sites, the Institute of Food (IFR) Research in Norwich and~     the University of Reading(UoR), in Reading. Samples from the participants at both sites will~     be analysed at IFR, UoR and companies in the United States.~   "
125134|NCT01929551|"~     The purpose of this study is to compare the glycemic index of a beverage made of natural~     concentrated mango puree with natural concentrated pear juice with other five different~     products based on natural mango and pear ingredients in the form of fruit or juice against a~     control of 50-gram glucose load.~   "
125135|NCT01929538|"~     Benign biliary strictures caused by chronic pancreatitis can be endoscopically treated with~     covered self-expandable metal stents (cSEMS).The purpose of the prospective randomized study~     is to define the optimal duration of stenting and the diameter of the cSEMS.~   "
125136|NCT01929525|"~     Effectiveness of silver nitrate solution in treatment of anal fistula is is aimed to be~     investigated.~   "
125137|NCT01929512|"~     To compare the pharmacokinetic characteristics between HCP1201 tablet 750/20 mg and~     co-administration of metformin 750 mg plus rosuvastatin 20 mg under fasted and fed state,~     respectively.~   "
125138|NCT01929499|"~     It has been reported that the immune status of patients with cancer were suppressed,~     especially those after surgery and adjuvant chemotherapy. Thus, immunotherapy may decrease~     the recurrence rate after surgery. CIK cells transfusion has been reported as an effect~     therapy in advanced cancers. In another retrospective study, investigators found that~     adjuvant CIK therapy would prolong the disease-free survival (DFS) for colorectal cancer~     patients.~      The purpose of this study is to determine wether adjuvant immunotherapy with CIK cells in~     patients with colon cancer after operation will prolong DFS, and overall survival (OS).~   "
125139|NCT01929486|"~     The purpose of this study is to investigate safety, pharmacokinetics, effect of regulatory T~     cell depletion with Mogamulizumab for advanced or recurrent cancer patients.~   "
125140|NCT01929473|"~     Serum samples will be corrected twice from the same youth subjects with one year interval.~      Seroincidence of pertussis will be estimated by the elevation of Ig-G-PT in paired sera from~     an identical individual.~      The relationship between the incidence and the demographic data or medical history of the~     subjects will be discussed.~   "
125141|NCT01929460|"~     Our hypothesis is that a single dose of antibiotics at time of EUS-guided pancreatic cyst~     aspiration is equally effective to the usual regimen of 3 days of post-procedural~     antibiotics.~   "
125142|NCT01929447|"~     The prevalence of OSAS is estimated at 2% and 4% for adult women and men respectively, most~     of whom are undiagnosed and untreated. The severity of the disorder is expressed by the Apnea~     Hypopnea Index (AHI) which is the number of Apnea/Hypopnea episodes per hours of actual sleep~     and the Respiratory Disturbances Index (RDI) which is an extended index incorporating in~     addition to the previous episodes also respiratory effort related arousal episodes. The high~     cost of in-lab full night PSG, together with long waiting lists for sleep studies, have led~     to the development of a variety of ambulatory sleep study systems.~      The primary objective of the study is to evaluate the newly developed WP200 with the unified~     probe (WP200U) compared to the currently used configuration of WP200 that uses an~     incorporated Nonin oximetry module in the sleep lab or in the home sleep environment.~   "
125201|NCT01928680|"~     It is a phase II trial to explore the efficacy and safety of cisplatin plus capecitabine in~     anthracycline and taxane-pretreated metastatic triple negative breast cancer patients.~   "
125202|NCT01928667|"~     The purpose of the study is to assess among others environmental and hygiene-related risk~     factors for microscopic colitis (MC), a common diarrheal disease.~   "
125143|NCT01929434|"~     Cerebral palsy (CP) is described as a group of permanent disorders affecting motor~     development and posture, resulting in activity limitation attributed to nonprogressive~     disturbances of the fetal or infant brain. The prevalence of cerebral palsy has increased~     among the children with low birth-weight, jaundice, respiratory distress and intrauterine~     infection and so on. The incidence of cerebral palsy is increasing gradually with increased~     neonatal survival rate. Although there are many kinds of functional therapy programs~     especially the rehabilitation treatment for cerebral palsy, their effects are limited.~     Increasing cerebral palsy patients become a heavy burden to the family and society. Stem cell~     based therapy, a new prospective therapy for central nervous system disorders, has the~     potential to repair the damaged brain tissue in patients with cerebral palsy.~      In this study, 300 patients with cerebral palsy will be divided into three groups and the~     investigators will use mesenchymal stem cells derived from umbilical cord to treat 100 CP~     patients of them randomly. We will also follow up the other 100 patients who only receive~     rehabilitation treatment and another 100 patients who accept neither stem cell therapy nor~     rehabilitation treatment. On this basis, as the investigators we can compare the efficacy of~     cell therapy and rehabilitation treatments for cerebral palsy patients.~      Multiple sources of assessment were used to ascertain and classify all cases of cerebral~     palsy. Particularly the Gross Motor Function Measure (GMFM) as an important valid and~     reliable outcome measure, has made it possible to evaluate the severity of movement~     disability，change over time and the effects of clinical interventions. It also will be the~     primary outcome measure in follow-up analysis of this study.~   "
125144|NCT01929421|"~     To assess the efficacy and safety of salvage tratment with Gemcitabine and S-1 Combination in~     metastatic colorectal cancer~   "
125145|NCT01929408|"~     The purpose of this study is to compare treatment methods and outcomes of patients diagnosed~     with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).~   "
125146|NCT01929395|"~     This is a 2 Phase study. In the first phase of the study, patients with palpable invasive~     breast cancer underwent pre-operative supine MRI and optical scanning in the surgical~     position. In the second phase of the study, patients with non-palpable invasive breast cancer~     or DCIS who desire breast conservation will be randomized to either a usual care group, or a~     group receiving a supine MRI in addition to conventional imaging (mammogram and prone MRI)~     and undergoing breast cancer resection without the wire localization technique.~   "
125147|NCT01929382|"~     The most frequent side effects associated with Actimmune (interferon gamma 1b) therapy are~     the occurrence of 'flu-like symptoms' (FLS),which might include fever, chills, muscle aches,~     and tiredness. Earlier studies have demonstrated that these symptoms are common in healthy~     volunteers as well as in patients.~      This study is designed to determine whether a titration of dosing reduces the frequency and~     severity of the FLS. A reported study with another interferon (interferon beta), demonstrated~     a reduction in the frequency and severity of the FLS when a titration of dosing was used.~     This study will compare the effects of the standard dose regimen with a titration regimen in~     healthy volunteers.~   "
125148|NCT01929369|"~     This pilot study will provide data to aid in the planning of a follow-up multi-center~     randomized, controlled trial (RCT). As such, the sample size for this pilot is not driven by~     formal statistical hypothesis testing. Rather, the sample size of 100 patients (50 per arm)~     was derived in consultation with the study PI and Co-PI who are experts in vascular surgery,~     and in particular, the field of hemodialysis access interventions. The results of this pilot~     study will provide the data that is necessary for generation of specific hypotheses that can~     then be formally tested in the follow-up RCT~   "
125149|NCT01929356|"~     Primary ciliary dyskinesia (PCD) is a rare disease, caused by impairment of the motile cilia.~     Patients present with chronic upper and lower respiratory tract infections. The therapy is~     mainly supportive and based on that of cystic fibrosis. Chest physiotherapy is one of the~     cornerstones of the therapy, however the influence of chest physiotherapy on lung function~     (short term and long term) is not clear. For interpretation of longitudinal lung function~     data it is important to examine the short time effect of chest physiotherapy. We hypothesize~     that a session of chest physiotherapy improves lung function and that thus lung function~     tests must be performed in a standardized way.~   "
125150|NCT01929343|"~     We propose that the systemic administration of lidocaine following the induction of~     cue-induced craving, relative to saline plus cue-induced craving or lidocaine without~     cue-induced craving, will block the reconsolidation of cue memories. This will lead to a~     reduction in cue-induced craving upon repeated testing as well as subsequent cocaine use and~     basal craving.~   "
125151|NCT01929330|"~     The aim of this study is to determine the bioequivalence of 5 x 0.1 milligram (mg) capsules~     compared to 1 x 0.5 mg capsule of dutasteride in healthy male subjects. The results of this~     study are expected to support registration applications for androgenetic alopecia (AGA) in~     Japan and other international markets.~   "
125152|NCT01929317|"~     This study is a Phase III, multicentre, randomized, initial double-blind study with~     subsequent open label phases. The study will havea screening phase (4 weeks), a dose increase~     effect verification phase (12 weeks), a down titration 1 phase (1 week), a long-term phase~     (39 weeks), down titration 2 phase (1 to 2 weeks) and a follow up phase. Subjects will be~     assigned to Ropinirole CR high-dose group or Ropinirole CR maintenance group at a ratio of~     3:1. This study is being conducted to evaluate the efficacy (effect of increasing Ropinirole~     dose from 16 mg/day to 18-24 mg/day) of the Ropinirole CR tablets in early and advanced PD~     patients who have not achieved an optimal therapeutic response with marketed Ropinirole~     Immediate release (IR) (15 mg/day) or marketed Ropinirole CR (16 mg/day) formulations.~   "
125153|NCT01929304|"~     Aim: Patient Perception: This aim broadly intends to use traditional script versus a brief~     video education vignette to determine understanding and preferences among general emergency~     department patients of rescue access techniques. A challenge of emergency care is providing~     patient education surrounding procedures in a standardized and patient-oriented manner. This~     data would provide insight on a patient's understanding of the risks and benefits of rescue~     access, assess patient preference, and potentially influence what rescue technique is~     employed in the future. This information may also give us insight onto why DIVA patients~     might refuse randomization.~   "
125154|NCT01929291|"~     The purpose of this study is to collect safety information from pre-adolescents, adolescents~     and adults after Boostrix vaccination is administered according to the approved prescribing~     information in Korea.~   "
125155|NCT01929278|"~     Clindamycin 1.0% - tretinoin 0.025% gel (CT Gel) is a reformulation of VELAC Gel that~     contains the same active ingredients (clindamycin 1.0% and tretinoin 0.025%) in a modified~     vehicle. This was a single-center, evaluator-blinded, randomized, placebo~     (vehicle)-controlled phase 1 study to evaluate the phototoxic potential of CT Gel using 24~     hour single applications of 3 sets of 3 study patches. The study expected to enroll~     approximately 40 healthy adult volunteers. Each set of study patches consisted of a CT Gel~     patch, a vehicle gel patch, and a blank patch (did not contain CT Gel or vehicle gel).~      After concurrent 24-hour single applications of all 9 patches, 1 set of patches (set A) was~     removed, and those sites were irradiated with 16 joules/cm2 of ultraviolet A light (UVA) and~     0.75 minimal erythema dose (MED) with UVA/ultraviolet B light (UVB). The second set of~     patches (set B) was removed, and those sites were irradiated with 16 joules/cm2 of UVA, 0.75~     MED with UVB/UVA, followed by 15 joules/cm2 of visible light (VIS). The third set of patches~     (set C) was then removed, and those sites served as a non irradiated control. Inflammatory~     responses and other cutaneous effects were scored 1 hour after patch removal and during~     follow-up visits at 24, 48, and 72 hours after patch removal.~   "
125156|NCT01929265|"~     This is a prospective, multicenter phase II trial designed to determine efficacy and safety~     of a chemoimmunotherapy with the combination of Bendamustine + Rituximab in patients with~     advanced untreated Indolent non Follicular non-Hodgkin Lymphomas (INFL).~   "
125157|NCT01929252|"~     The aim of this study was to investigate the analgesic efficacy of dexmedetomidine~     administration in wound infiltration for total abdominal hysterectomy.~   "
125158|NCT01929239|"~     This is a Phase Ib Pilot study of anti-PSMA designer T cells in metastatic prostate cancer.~     Subjects will receive escalating doses of T cells, with either low or moderate dose~     Interleukin 2. The T cells are collected by pheresis and then genetically modified, and given~     in a one time infusion.~   "
125159|NCT01929226|"~     To evaluate the safety and tolerability and pharmacokinetics (PK) of a single intravenous~     (IV) dose of ETI-204 in adult volunteers.~   "
125160|NCT01929213|"~     This study is designed to investigate the pharmacokinetic drug interaction and safety after~     oral administration of Udenafil(DA-8159) and Bosentan in healthy volunteers.~      Design: Randomized, open-label, multiple-dose, three-treatment, three-period, six-sequence,~     Williams design~      Investigational Product: Udenafil, Bosentan~   "
125161|NCT01929200|"~     This study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating~     such patients. The primary endpoint is to compare the recurrence-free survival after 1-year~     or 2-year treatment with icotinib.~   "
125162|NCT01929187|"~     Background: Onychomycosis, the most common nail disorder, is a superficial fungal infection~     affecting toenails more than fingernails. Onychomycosis can cause pain and discomfort and has~     the potential to be a source of morbidity. Although oral antifungal agents achieve a better~     complete cure rate for onychomycosis, many patients are worried about the side effects and~     unwilling to take oral medications. Phytonail is a mixture of herbal active ingredients~     including tea tree oil, lavender oil and Australian blue cypress oil with BioEqual carrier~     system. A preliminary trial has shown a 100% KOH negative rate in 32 nails after 12 weeks of~     Phytonail therapy. Amorolfine 5% nail lacquer (Loceryl) is a broad-spectrum morpholine~     antifungal demonstrated 60-75% mycological cure rate in several randomized controlled trials~     for the treatment of toenail onychomycosis.~      Objective: To evaluate the efficacy and safety of Phytonail relative to amorolfine 5% nail~     lacquer in the treatment of toenail onychomycosis.~      Methods: This is a randomized, parallel-group, open-labeled study in adult subjects with~     toenail onychomycosis. In this study, 60 eligible patients will be randomized in a 1: 1 ratio~     to one of the two treatment groups: Phytonail or amorolfine 5% nail lacquer. Before~     randomization, patients are to have onychomycosis in at least one great toenail with positive~     KOH examination and positive fungal culture. During the treatment phase, Phytonail will be~     applied twice daily and amorolfine 5% nail lacquer once weekly for 16 weeks to all affected~     toenails. Physician's assessments and photographic analyses will be carried out at baseline,~     Week 4, 8, 16, and 24. Mycological evaluation including KOH examination will be performed at~     baseline, Week 4, 8, and 16. Fungal culture will be performed at baseline and for KOH~     negative patients.~   "
125163|NCT01929174|"~     The purpose of this protocol is to measure the relaxation of the heart in subjects with~     single ventricles who have undergone the surgical Fontan procedure. We will do this by~     measuring relaxation with MRI, echocardiography, and cardiac catheterization and compare to~     blood levels that measure heart scarring. We will also measure relaxation before and after~     boluses of intravenous (IV) fluids to see if the relaxation changes when there is more fluid~     in the heart. Measurements of heart relaxation will be obtained from the MRI, echocardiogram,~     and cardiac catheterization for each patient and compared to blood markers of heart scarring.~     We aim to compare all of these measurements to see if we can accurately identify heart~     scarring and, if present, how much it correlates with impaired heart relaxation.~   "
125164|NCT01929161|"~     The specific aim of this study is to test whether oxytocin (OT) boosts the positive emotion~     yield of a new wellness behavior (Lovingkindness meditation or Mindfulness meditation) and~     thereby increases nonconscious motives that shape daily behavioral decisions to repeat it,~     which in turn foster positive emotions that further augment nonconscious motives in an upward~     spiral dynamic.~      The proposed research targets three hypotheses: (1) Oxytocin manipulation magnifies (i.e.,~     moderates) the positive emotion yield of Lovingkindness meditation; (2) The positive emotion~     yield of meditation, which varies by experimental condition, increases the nonconscious~     incentive salience of Wellness Behavior-related cues; and (3) Behavioral decisions predict~     positive emotions, sparking the relationships among OT manipulation, positive emotion yield,~     and nonconscious incentive salience of Wellness Behavior-related cues.~   "
125213|NCT01928524|"~     The purpose of this study is to determine maximal tolerable dose (MTD) of the combination of~     docetaxel, oxaliplatin and S1 (DOS) to patients with gastric cancer.~   "
125248|NCT01928069|"~     Objective:~      Primary objective of the present study was to compare the single dose bioavailability of~     Torrent's Montelukast Sodium 10 mg tablet and Innovator's(Merck)Singulair 10 mg tablet.~     Dosing periods were separated by a washout period during fed study.~      Study Design:~      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence~     Study~   "
125165|NCT01929148|"~     We already demonstrated that the addiction of PBS to Total Laparoscopic Hysterectomy (TLH)~     has no negative effects in term of ovarian function, evaluated by anti-Müllerian hormone~     (AMH), Follicle Stimulating Hormone (FSH), Antral Follicle Count (AFC), mean ovarian~     diameters and Peak Systolic Velocity (PSV). In addition, in our experience, no negative~     surgical outcomes (in terms of operative time, intraoperative blood loss, postoperative~     hospital stay, postoperative return to normal activity and complication rate) are related to~     PBS step in TLH.~      Although the good statistical reliability of our retrospective data, we want to prospectively~     confirm our results. Moreover we aim to refine PBS safety demonstration by collecting also 3D~     ultrasound parameters [AFC, ovarian volume (OV), Vascularization Index (VI), Flow Index (FI)~     and Vascularization Flow Index (VFI)]. Hormonal and ultrasonographic parameters may possibly~     be unified into a new diagnostic algorithm (already at an advanced stage of production in UMG~     Department) able to estimate the ovarian function both in term of reproductive ability that~     in term of distance from menopause.~   "
125166|NCT01929135|"~     Periodontal disease (PD) is an inflammatory, infectious and destructive condition of the~     tissues surrounding the teeth. However, even if bacteria are required to initiate periodontal~     disease, the immune response is responsible for most of the destruction of the periodontal~     tissues. Statins may be used to control the immune response to periodontal pathogens, a~     factor that has not yet been managed clinically and even less massively.~      Recently it has been reported the pharmacological effectiveness of topically used statins.~     For periodontal disease, at least four well conducted clinical trials have been published~     using a topically statin formula for pocket irrigation in adult populations with chronic~     periodontal disease, observing surprising clinical results in all of them (with clinical and~     statistical significance) and no adverse reactions.~      The purpose of the present study is asses the effectiveness of a medicated 2% atorvastatin~     dentifrice, as complement to non-surgical conventional periodontal treatment. Clinical~     examination will be made at the beginning and after one month of treatment.~   "
125167|NCT01929122|"~     The purpose of this study is to explore the effects of cooked navy bean powder or rice bran~     consumption on the stool microbiome and metabolome of colorectal cancer survivors and healthy~     adults.~   "
125168|NCT01929109|"~     The purpose of this study is to measure how much of the study drug, LY2409021, gets into the~     blood stream and how long it takes the body to get rid of it when given to participants with~     different levels of kidney function. There are five study groups. Each participant may only~     enroll in one group. Participants in groups 1 through 4 may be healthy or may have mild,~     moderate, or severe kidney disease. They will complete one study period lasting about 29~     days. Study group 5 will enroll participants with kidney disease who are on dialysis. They~     will complete two study periods which together last about 59 days. Screening is required~     within 21 days prior to the start of the study for all participants.~   "
125169|NCT01929096|"~     1. To investigate the efficacy and safety of multi-doses Compound Edaravone Injection~          versus Edaravone Injection for acute ischemic stroke patients;~        2. To provide evidence for the design of Compound Edaravone Injection Phase III trial.~   "
125170|NCT01929083|"~     Female sex is an independent risk factor for the potentially fatal drug-induced arrhythmia~     (irregular heartbeat) known as torsades de pointes (TdP), which is associated with~     prolongation of the corrected QT (QTc) interval on the electrocardiogram (ECG). Mechanisms~     for this increased risk in women are not well-understood. QTc interval duration has been~     shown to fluctuate throughout the phases of the menstrual cycle. Evidence indicates that the~     QTc interval response to drugs that may cause TdP is greater during the menses and ovulation~     phases of the menstrual cycle, during which serum progesterone concentrations are lowest, and~     lesser during the luteal phase, during which serum progesterone concentrations are highest.~     Additional evidence from our laboratory suggests that progesterone may be protective against~     TdP. Specific Aim 1: Establish the influence of oral progesterone administration as a~     preventive method by which to diminish the degree of drug-induced QT interval prolongation in~     women. Working hypothesis: Oral progesterone administration effectively attenuates enhanced~     drug-induced QT interval response in women. To test this hypothesis, progesterone or placebo~     will be administered in a crossover fashion to women during the menses phase of the menstrual~     cycle. QTc interval response to low-dose ibutilide, a drug known to lengthen the QT interval,~     will be assessed. The primary endpoint will be individually-corrected QT interval (QTcI)~     response to ibutilide, in the presence and absence of progesterone, which will be assessed~     by: 1) Effect on maximum change in QTcI, and 2) Area under the QTcI interval-time curves~     (AUEC). At the conclusion of this study, we will have established that oral progesterone~     administration is a safe and effective method of attenuating drug-induced QT interval~     prolongation.~   "
125171|NCT01929070|"~     The purpose of this study is to evaluate the pharmacokinetics of omega-3 between rosuvastatin~     and omega-3 coadministration and HCP1007 in healthy male volunteers.~   "
125172|NCT01929057|"~     The purpose of this study is to determine the response of acne patients and healthy control~     patients to the P. acnes bacteria. Half a tube of blood will be drawn from all participants~     to determine whether or not they have antibodies to the P. acnes bacterium. Anywhere from 1~     to 4 skin biopsies of acne pimples or normal control skin will be taken from all subjects for~     further analysis in the lab to determine whether the inflammation in these pimples can be~     reduced using anti-P.acnes antibodies.~   "
125173|NCT01929044|"~     The aim of the study is to assess the efficacy of Buscopan® (hyoscine butylbromide) in~     comparison to 654-II (anisodamine)in acute gastric or intestinal spasm-like pain.~   "
125174|NCT01929031|"~     The primary objective of this study is to compare the efficacy of a combination product~     containing ibuprofen 400 mg and caffeine 100 mg versus either ingredient alone as well as~     placebo for the treatment of post-surgical dental pain over an eight-hour period followed by~     a single dose of study medication (study stage 1). A secondary objective is to evaluate~     efficacy of multiple doses of the combination in comparison to ibuprofen alone over a 5-day~     post-surgical period (study stage 2).~   "
125175|NCT01929018|"~     The objective of this study is to examine the feasibility of using a collaborative-care,~     home-based rehabilitation program to improve functional outcomes for people recovering from~     lower limb amputation caused by vascular problems and/or diabetes complications. The primary~     hypothesis is that the rehabilitation program will result in greater improvements in~     performance-based and participant-reported measures of physical function, compared to~     standard of care after outpatient rehabilitation.~   "
125176|NCT01929005|"~     The investigators propose an innovative new model of care in which patients identified to be~     at high risk of hospitalization are offered care by a physician who will direct their care~     both in the hospital and in clinic but is able to do so because they see patients only at~     high risk of hospitalization. This allows these physicians to have a panel of patients that~     is small enough that they can provide them with continuing ambulatory care but sick enough~     for those physicians to have enough of their patients hospitalized at any time to justify~     having the physician spend several hours each morning seeing those patients in the hospital,~     making the model economically viable and clinically valuable for the patient. The~     investigators estimate that each of the 5 physicians the investigators propose to establish~     in this model will serve a panel of about 200 patients in steady state with an average of 10~     days of expected hospitalization and $75,000 each in Medicare spending per year, totaling $75~     million annually. The investigators estimate that a 1% reduction in costs for these patients~     will be more than enough to cover the ongoing costs of the model the investigators propose;~     this is because the investigators' program reorganizes care rather than adding new forms of~     care.~   "
125177|NCT01928992|"~     The purpose of this pilot study is to provide credible performance estimate information in~     order to properly plan, design, and power a larger clinical study.~   "
125178|NCT01928979|"~     Thrombus outcome data will be collected retrospectively during 2011-2012 as a historical~     baseline of SoC with oral VKA (Vitamin K Antagonist(s) for the treatment of patients with~     nonvalvular AF or atrial flutter documented with LA/ LAA thrombi on transesophag-eal~     echocardiography (TEE).~      The study is a company-sponsored, global, multi-center, retrospective, non-interventional~     study. Patients who suffered from hemodynamically stable nonvalvular AF or atrial flutter and~     had a diagnosed LA/ LAA thrombus between January 1st, 2011 and December 31st, 2012 will be~     identified through screening and review of medical records and included in the registry.~     Retrospective patient data will be collected from May 2nd, 2013 to May 2nd, 2014. The~     observation of each patient will cover the period from the diagnosis of an LA/ LAA thrombus~     until the end-of-treatment TEE following the 3-12 week SoC anticoagulation (AC) therapy. If~     no end-of-treatment TEE has been performed during 3-12 weeks of AC therapy, the observational~     period will end at 12 weeks after diagnosis at the latest. If more than one TEE was performed~     during treatment, the thrombus outcome will be collected from the last TEE performed within~     12 weeks of treatment start.~   "
125179|NCT01928966|"~     The purpose of this study is to determine if the inclusion of 1.5 ounces of pumpkin seeds per~     day in the diet of women will alter dietary fatty acid intake or blood pressure.~   "
125180|NCT01928953|"~     This prospective hybrid longitudinal study was conducted in the United States (US), Canada,~     the United Kingdom (UK), and Germany. To obtain the most complete and comprehensive~     understanding of the burden of opioid-induced constipation (OIC) in these countries, this~     study used a combination of web-based, longitudinal patient survey, retrospective data~     abstraction from medical records, and a prospective physician survey.~      The primary objective of this study was to estimate the rate of inadequate response to~     laxatives (LIR), which was defined as having sufficient laxative use (at least one laxative~     use ≥ four times per reference period), and inadequate response (defined as fewer than three~     bowel movements (BMs) OR at least one of the following symptoms on the Patient Assessment of~     Constipation Symptoms (PAC-SYM) measure scored as moderate, severe or very severe: BMs too~     hard, straining to have a BM, feeling like you didn't finish a BM, and feeling like you had~     to pass a BM but could not), in a cohort of non-cancer pain and cancer pain (separately)~     participants with OIC, by country and overall.~      The secondary study objectives are as follows:~        1. To estimate the rate of LIR for two subgroups: 1xLIR and 2xLIR. 1xLIR was defined as use~          of at least one laxative agent ≥ 4 times in the reference period while 2xLIR was defined~          as the use of at least two laxative agents, each used ≥ 4 times in the reference period;~        2. To describe the baseline demographic and clinical characteristics, including prior~          health status, comorbidities, constipation-related GI symptoms, and concomitant~          medications of patients with OIC;~        3. To describe drug utilization and self-management of OIC;~        4. To describe the pre-index and post-index healthcare resource utilization and estimate~          costs associated with the diagnosis, treatment, and general management of OIC (including~          laxative use) and events attributed to OIC, including both direct and indirect costs;~        5. To describe patient-reported impact of OIC on health-related quality of life,~          productivity, and pain management;~        6. To describe patient-reported treatment satisfaction with laxative use; and~        7. To describe physician-reported awareness of OIC and symptoms and understanding of~          patient-reported impact of OIC.~   "
125181|NCT01928940|"~     This is a Japanese Phase I/II, open-label, non-controlled study to evaluate the safety,~     tolerability, pharmacokinetic profile, and efficacy of the combination of GSK2118436 and~     GSK1120212 in subjects with BRAF V600E/K mutation positive advanced solid tumors (Phase I~     part) and BRAF V600E/K mutation positive cutaneous melanoma (Phase II part).~   "
125182|NCT01928927|"~     The main goal of this study was to see if a drug called telmisartan would decrease fibrosis~     (scarring) and inflammation (irritation) in people who are infected with HIV and doing well~     on their HIV medications. The study was also done to see what effects telmisartan has on~     other signs of disease and inflammation in the body, and to see whether people who have HIV~     can take telmisartan safely and without side effects that make them want to stop the drug.~     Telmisartan is FDA-approved for treating high blood pressure and decreasing the chance of~     heart attacks and strokes in people over the age of 55 years of age who are at high risk for~     these events.~   "
125183|NCT01928914|"~     This will be a randomized, single-blind, placebo controlled, parallel group study.~     Approximately 260 subjects will be enrolled in five groups. This study is designed to compare~     the effects of tafenoquine, administered as single dose as well as administered over three~     consecutive days, on the changes in QT duration to those observed in subjects dosed with~     either moxifloxacin or placebo.~   "
125184|NCT01928901|"~     Proof of concept: Superiority of Bronchipret or Sinupret to placebo in respect to mucociliary~     clearance~   "
125185|NCT01928888|"~     The purpose of this study is to compare the efficacy and safety of a single oral~     administration of 1000 mg Talcid® (study medication), a single oral administration of 10 mg~     famotidine and a single oral administration of placebo (comparator without an active~     substance) in treating the symptoms of acute heartburn episodes. The study is designed to~     collect more efficacy data on Talcid® in patients using self-medication to relief the~     symptoms of acute heartburn.~   "
125186|NCT01928875|"~     The purpose of this study is to demonstrate that using Surgical Pleth Index (SPI) and Entropy~     in adjunct to other clinical information decreases the occurrence rate of inadequate~     anesthesia events, bradycardia and hypotension in comparison to standard clinical practice~     during anesthesia. Adequacy of Anesthesia (AoA) monitoring comprises the use of both Entropy~     and SPI measurements. Adequacy of anesthesia will be monitored using non-invasive blood~     pressure, blood oxygen saturation (SpO2), ECG, and neuromuscular transmission (NMT).~   "
125187|NCT01928862|"~     To study the efficacy and safety of Prepopik® in children aged 9 to 16 years for overall~     colon cleansing in preparation of colonoscopy~   "
125188|NCT01928849|"~     The objectives of this study are, to test the effectiveness of Valproic Acid (VPA) in the~     prevention of chronic neuropathic and post-amputation pain, as well as to further define the~     underlying inflammatory and epigenetic mechanisms that lead to the development of such~     chronic pain.~      HYPOTHESES AND QUESTIONS~      Hypothesis 1: The use of oral valproic acid in combination with regional anesthesia in~     surgical limb-injury patients will decrease the incidence of chronic nerve injury and~     post-amputation pain.~      Goal 1: In a blinded, randomized placebo-controlled, multi-center clinical trial,~     investigators will determine if oral VPA added to regional anesthesia and standard~     perioperative management will reduce the incidence of nerve injury and post-amputation pain~     when compared with regional anesthesia alone.~      Hypothesis 2: The transition from acute to chronic pain is mediated via epigenetic mechanisms~     (differential DNA methylation) in genes involved in nociception.~      Goal 2: Investigators will analyze the DNA methylation patterns of patients with different~     types of neuropathic and post-amputation pain and determine if they are altered by VPA.~   "
125189|NCT01928836|"~     The purpose of this study is to verify clinical utility of a simple blood test comprising of~     four protein- based markers for risk stratification of patients presenting symptoms related~     to lung cancer.~   "
125190|NCT01928823|"~     Since decades, D-Cycloserine (DCS, drug class: Oxazolidinone) is proven to be an effective~     antibiotic agent in the treatment of tuberculosis. Furthermore it takes action in the central~     nervous system as an partial agonist on NMDA receptors. Because of glutamate mediated~     neuronal long-term potentiation in long-term memory DCS has an augmenting effect on emotional~     learning, as it occurs in exposure therapy of anxiety disorders. In this context we use DCS~     in addition to exposure therapy as a part of cognitive behavioral therapy (CBT) in patients~     suffering from agoraphobia with or without panic disorder. Thereby DCS is applicated oral as~     a capsule of 50mg, on three consecutive therapy sessions.~   "
125191|NCT01928810|"~     Physical activity (treadmill) prior to in-vivo exposure supports the effect of cognitive~     behavioural therapy in patients with panic disorder and agoraphobia.~   "
125192|NCT01928797|"~     The purpose of the study is to learn more about how the heart works during cesarean delivery~     under spinal anesthesia (medicines given in the spine that numb parts of your body to block~     pain) in women. The investigators would like to find out if the information about the heart~     can help in treating blood pressure changes that occur during the cesarean delivery. The~     investigators would also like to find out if this information can help reduce the chances of~     nausea and vomiting during the cesarean delivery.~      The activity of the heart changes during spinal anesthesia and cesarean section. In the past,~     a sensor placed directly into the heart was the only way to see how the heart worked.~     Currently, there are monitors that can sense the heart's activity via sensors that are placed~     on the skin during cesarean delivery.~      In this study, the investigators will use the ICON cardiac output (ICON) monitor. The ICON~     monitor is approved by the US Food and Drug Administration (FDA) to monitor (check) the~     activity of your heart.~      This study aims to:~        1. Determine if additional cardiac output measurements help anesthesiologists maintain~          appropriate hemodynamics as defined as within 20% of baseline BP and if it changed their~          choice of vasopressors (primary outcome).~        2. Determine if additional cardiac output measurements help to decrease the incidence of~          nausea and vomiting during cesarean delivery (secondary outcome).~   "
125193|NCT01928784|"~     The aim of this prospective study is to explore the pain-alleviating effect of low-energy~     extracorporeal shock wave therapy(ESWT) in patients with chronic low back pain.~   "
125194|NCT01928771|"~     The purpose of this study is to determine whether Benralizumab reduces the number of asthma~     exacerbations in patients who remain uncontrolled on high doses of ICS-LABA.~   "
125195|NCT01928758|"~     The overall aim of this project is to evaluate the effect of progressive nicotine reduction~     in cigarettes on smoking behavior, toxin exposure and psychiatric symptoms in smokers with~     comorbid mood and/or anxiety disorders.~      Smokers with mood and/or anxiety disorder will smoke research cigarettes that will contain~     either a) nicotine content similar to their preferred usual brand of cigarettes, or b)~     nicotine content per cigarette that is progressively reduced from approximately 11 mg to 0.3~     mg over 6 months.~      It is our hypothesis that nicotine intake will decline as a function of cigarette nicotine~     content in the Reduced Nicotine Content group without significant increases in tobacco smoke~     exposure, severity of nicotine withdrawal symptoms, mood and anxiety symptomatology or~     protocol non-adherence over time in the Reduced Nicotine Content group as compared with the~     control group.~   "
125196|NCT01928745|"~     To diagnose acid base disturbances using blood gas analysis, multiple approaches are~     currently in use. These include the classic Henderson-Hasselbach bicarbonate approach and the~     physiochemical approach by Stewart1. All have shown to be mathematically compatible2.~      Diagnosing the metabolic component of acid base disturbances relies on the assessment of the~     so called ion gaps: the anion gap for the classic acid-base approach and the strong ion~     difference (SID) for the Stewart approach. This gap may unveil unidentified anions to provide~     a more accurate diagnosis. In particular they allow differentiating between relative~     hyperchloremia and other strong ions such as lactate, ketones, salicylates, citrate and~     ethylene glycol3.~      The accuracy of both gaps relies on the estimation of the weak acid dissociation: A-. This A-~     is dependent on the total concentration of weak acids (Atot) of which albumin is the most~     important and the effective dissociation constant for these (Ka), which determines the~     dissociated fraction of the Atot. This dissociation fraction needs to be accounted for in the~     ion gaps. This is reflected in the recommendation to correct the anion gap for albumin and~     incorporated in the SID which includes a factor for albumin by design3,4. However, the~     correction factor for albumin is currently based on data from animals and healthy~     volunteers4-9. In the critically ill albumin and protein content are very different compared~     to healthy volunteers, most notably in sepsis. Further, it is unknown if subunit composition~     of albumin is different in these patients. In addition, different protein species may be~     either up or downregulated in the critically ill1,8,9.Therefore from a pathophysiological~     point of view Atot and Ka and thus A- may differ in the critically ill. However it has not~     been previously investigated if and to what extent these matters affect Atot and Ka and~     therefore A- in this population.~      In addition, previous studies looking into this values showed a higher than expected value of~     unmeasured anions from the gap calculations. Despite rigorous experimental effort including~     high performance liquid chromatography, the origin of these unmeasured anions have not yet~     been elucidated17-20. However if the assumptions made in the Stewarts approach would not be~     valid, the existence of these unknown anions may have to be questioned.~      Thus it is of great interest to experimentally determine the exact contribution of the weak~     acids and their dissociation in sepsis. This could have major implications for these patients~     because different assumptions will ultimately lead to alterations in their calculated anion~     gap or SID. This may reduce unnecessary diagnostic test, alter final diagnosis and hence~     alter therapy.~      In this study the investigators aim to experimentally determine the Atot and Ka and thus~     their dissociated fraction A- in critically ill septic patients admitted to the intensive~     care unit by using in vitro CO2 tonometry, plasma dialysis and Marquardt regression analysis.~     In addition, as a control the investigators will do the same for patients admitted to the~     intensive care after routine cardiac surgery. Furthermore Atot and Ka values for both groups~     will be compared to values obtained from human volunteers in a previous study4.~      To achieve this, the investigators will plot CO2 versus pH titration curves from plasma~     samples of these patients. The investigators will then use Marquardt nonlinear regression~     analysis to quantify Atot and Ka and the SID by simultaneously solving for these~     parameters21. To make the quantification for Atot and Ka more robust, the investigators will~     also perform the same experiments after dialyzing the obtained plasma samples against a~     crystalloid solution of known composition in order to eliminate errors related to estimation~     of the SID. Finally, Atot and Ka values for both groups will be compared to values obtained~     from human volunteers in a previous study4. For application in the bicarbonate and base~     excess centred frameworks, Atot and Ka values will be related to albumin and protein content~     to update the correction factor for the anion gap in critically ill.~   "
125197|NCT01928732|"~     VA Cooperative Study CSP #591 is designed to compare the effectiveness of two types of~     psychotherapy, Prolonged Exposure and Cognitive Processing Therapy, for treating~     posttraumatic stress disorder (PTSD) in male and female Veterans. Despite solid evidence that~     both treatments are effective in Veterans and non-Veterans, there is a lack of evidence about~     the effectiveness of these treatments compared with one another.~      The sample will include 900 male and female Veterans with PTSD due to any traumatic military~     event. Veterans who are eligible and agree to participate in the study will be randomly~     assigned (by chance) to receive Prolonged Exposure or Cognitive Processing Therapy. The~     standard dose of treatment is 12 weekly sessions but Veterans who improve more rapidly may~     finish in fewer sessions and Veterans who improve more slowly may have additional sessions.~     The primary outcome is improvement in PTSD symptoms after treatment. The outcome will be~     measured at regular follow-up visits that will occur at the middle and at the end of~     treatment and then 3 and 6 months later. The investigators will measure other outcomes,~     including additional mental health problems, functioning, quality of life, and use of~     treatments for mental and physical problems. The investigators also will measure Veterans'~     treatment preference and examine whether Veterans who get the treatment they prefer do better~     than Veterans who get the less-preferred treatment.~      As a large multi-site trial with men and women, CSP #591 is designed to provide conclusive~     information about whether one treatment is better than the other, overall and for different~     types of patients-for example, men vs. women, combat Veterans vs. Veterans who experienced~     military sexual trauma, and older vs. younger Veterans. Regardless of the outcome, patients~     will have more information to help them make an informed decisions about which treatment to~     choose and VA will have stronger evidence to help make care Veteran-centered.~   "
125198|NCT01928719|"~     The overall goal of this study is to address the question of whether progressively lowering~     nicotine content in cigarettes can reduce or eliminate nicotine dependence in smokers of low~     socioeconomic status~   "
125199|NCT01928706|"~     Purpose: the aim of the present study was to analyze the impact of mandibular denture~     relining with soft or hard denture liners in the oral health related quality of life (OHRQoL)~     of edentulous patients.~      The null hypothesis was that there would be no difference in OHRQoL findings after mandibular~     denture relining between patient groups treated with hard or soft denture liners.~   "
125200|NCT01928693|"~     This Phase II study will evaluate the safety and efficacy of three fluoroquinolone ophthalmic~     agents to determine the optimal treatment in patients with infectious corneal ulcers.~   "
125203|NCT01928654|"~     Macular edema is the most important cause of visual impairment in diabetic patients.~     Intravitreal injections of antiVEGF (vascular endothelial growth factor) agents and laser~     treatment are two effective therapies for stabilising visual acuity. However, antiVEGF~     therapy is very expensive and potentially needs to to be repeated for all patients life.~     Laser treatment, according to modified ETDRS (early treatment diabetic retinopathy study),~     produces retinal burns with possible negative consequences such as alterations in the visual~     fields.~      With micropulse treatment modality laser energy is delivered in short pulses (micropulses)~     rather than as a continuous wave. In this way the amount of energy delivered to the retina~     and retinal pigment epithelium (RPE) is significantly reduced. This finer control of the~     photothermal effects should avoid any retinal and RPE damage. At the same time, according to~     several published reports, the efficacy of treatment appears to be equivalent to conventional~     laser therapy.~      Previous studies investigated the effects of 810nm micropulse laser therapy. Recently, this~     treatment modality has been made available also with 577nm wavelength, which corresponds to~     the maximum absorption level for blood. Aim of this study is to assess the safety and~     efficacy of 577nm micropulse laser treatment compared to conventional modified ETDRS laser~     therapy.~   "
125204|NCT01928641|"~     Intravenous tissue plasminogen activator (IV t-PA) is the only proven treatment of hyperacute~     cerebral infarction. The outcome of this treatment highly depends on the time from symptom~     onset to the administration of thrombolytic agent. Last known normal time is widely used as~     the standard to determine the symptom onset. These stroke symptoms are usually caused by a~     sudden decrease in cerebral blood flow related with an embolic or thrombotic event. However,~     in some cases various symptoms may occur one after another.~      Myocardial infarction is also caused by a sudden caseation of blood flow. The symptom of~     myocardial infarction usually contains chest pain, and it is easy to identify the exact time~     of onset. In contrast, cerebral infarction may cause various symptoms according to the~     infarcted area of the brain, and sometimes multiple symptoms are presented in rapid~     succession. Therefore, it may be much unclear and uncertain to determine the onset time of~     cerebral infarction. Despite the importance of onset time in therapeutic decision making,~     there was no study focusing on the certainty of onset time in cerebral infarction patients.~      In this study, we will investigate the subjective certainty of patient about the onset time~     in clear-onset cerebral ischemia. The discrepancy in diagnosing the onset time will be~     analyzed among the clinicians involved in the practice. Then, the factors associated with~     this uncertainty will be verified.~   "
125205|NCT01928628|"~     This study aims to compare and assess the efficacy and the safety of the combination agent of~     Lercanidipine and Valsartan and monotherapy of Lercanidipine alone in patients with essential~     hypertension~   "
125206|NCT01928615|"~     This open-label, randomized crossover study evaluated the quality of life, efficacy, and~     safety of subcutaneous Herceptin (trastuzumab) injected either into the thigh or the upper~     arm of participants with early HER2-positive breast cancer.~   "
125207|NCT01928602|"~     The few studies looking systematically into the neurophysiological and neuropsychological~     components of available therapies for chronic aphasia are highly heterogeneous in nature.~     Results from these studies have, unsurprisingly, indicated heterogeneous results, such as~     dissimilar neural outcomes associated with neuropsychological gains. There is, therefore, no~     consensus of how a successful therapy— that is, one that produces a measurable language gain~     in either production or comprehension —impacts the functional language networks of the brain~     in a specific type of aphasia population.~      A recent study has shown that inner speech (the imagination of speech) involves networks and~     areas dissociable from those implicated in speech production. Further, behavioural analysis~     has shown an interesting discrepancy between inner speech and overt speech (also called~     speech production) in a small chronic aphasia population: some participants elicited poor~     inner speech coupled with relatively intact overt speech, while others elicited relatively~     intact inner speech coupled with poor overt speech. This unexplored discrepancy implies that~     inner speech and speech production are dissociable, though share similar networks.~      This discrepancy, and the notion that these speech components share a similar network, drives~     this study's hypothesis that improvement in speech production after rehabilitation might be~     facilitated by an intact inner speech network. Much as good athletes visualise their~     performance before the actual event in order to increase their chances of success, so too~     might intact inner speech facilitate speech production, helping to visualise the word in~     order to increase the success of produced speech.~      By studying a specific component of speech—inner speech—in a relatively homogeneous~     population of chronic expressive aphasics, the present study provides an explicit, critical~     means of understanding neurophysiological (as assessed by functional magnetic resonance~     imaging) and neuropsychological (as assessed by language batteries and personal~     questionnaires/interviews) changes occurring during speech therapy.~      As a secondary objective, this study will explore the effectiveness, feasibility and~     adherence to an at-home computerised aphasia software delivered via a portable tablet.~   "
125208|NCT01928589|"~     Women with ER negative breast cancer have a higher risk of the cancer returning in the breast~     after whole or partial breast radiation than women with ER positive breast cancer. In a small~     study at Johns Hopkins, women were treated with partial breast irradiation and chemotherapy~     given at the same time. This combined treatment was safe and women with ER negative breast~     cancer did just as well as women with ER positive cancer.~      We are now testing in a bigger study whether giving partial breast irradiation and~     chemotherapy at the same time (our new method) has the same side effects and outcomes as~     giving partial breast irradiation and chemotherapy at different times(older method). In this~     study women who had their breast cancer removed but need radiation to the breast will be~     randomized to partial breast irradiation at the same time as chemotherapy or partial breast~     radiation at a different time than chemotherapy. Randomization is like flipping a coin but in~     this study about 2 of every 3 women will get the new method.~   "
125209|NCT01928576|"~     Response Rate~   "
125210|NCT01928563|"~     This study is designed to investigate the pharmacokinetic drug interaction between Udenafil~     and Dapoxetine in healthy male subjects~      Design : Randomized, open-label, 3-treatment, 6-sequence, 3-period crossover study~      Investigational Product : Udenafil, Dapoxetine~   "
125211|NCT01928550|"~     The purpose of this study is to evaluate the effectiveness of investigational Doppler Optical~     Coherence Tomography (OCT) and OCT angiography in the management of proliferative diabetic~     retinopathy (PDR - a leading cause of blindness in diabetic patients) before and after~     treatment. Angiography is the mapping of the blood vessels, and Doppler detects blood flow.~     PDR is due to poor oxygen circulation in smaller blood vessels in the back of the eye~     (retina), and is observed in 80% of people who have had diabetes for more than 10 years. This~     study will look at how blood flow to the eye is affected before and after treatment.~   "
125212|NCT01928537|"~     This study will examine the effect intravenously administered rigosertib has on the~     relationship between bone marrow blasts response and overall survival in myelodysplastic~     syndromes (MDS) patients who have 5-30% bone marrow blasts and who progressed on or after~     treatment with azacitidine or decitabine.~   "
125214|NCT01928511|"~     Patients with Chronic Hepatitis B on long term oral antiviral therapy have to continue~     treatment indefinitely unless they achieve HBeAg seroconversion or HBsAg seroclearance, when~     therapy can be stopped. While HBeAg seroconversion is a more achievable endpoint, only 20-25%~     of patients develop this after one year of oral antiviral therapy. HBsAg seroclearance is~     universally infrequent. Strategies to improve these endpoints such as combination oral~     antiviral therapy have not been generally successful and recently studies have examined the~     possibility of switching or adding peginterferon therapy. However these have not been tested~     adequately in the group of patients that have been on long term oral antiviral therapy.~     Consequently this study was conceived to evaluate whether switching or adding peginterferon~     compared to continuing oral antiviral therapy are more efficacious strategies. HBeAg positive~     and HBeAg negative patients (n=310)will be randomised to continue oral antiviral therapy,~     switch or add pegylated interferon for 48 weeks in a ratio of 1:2:2 respectively. The study~     endpoints are HBsAg seroclearance, reduction of qHBsAg >1 log, qHBsAg<200 IU/ml, HBeAg loss~     and seroconversion, and HBV DNA suppression, all at week 72.~   "
125215|NCT01928498|"~     The purpose of this study is to evaluate the effectiveness of paclitaxel-coated balloon~     catheter to prevent restenosis after PTA (percutaneous transluminal angioplasty) of~     hemodialysis access (HA) in comparison with the uncoated PTA balloon catheter.~   "
125216|NCT01928485|"~     This randomized phase II trial studies how well green tea extract works in treating patients~     with low-risk prostate cancer. Green tea extract contains ingredients that may prevent or~     slow the growth of certain cancers.~   "
125217|NCT01928472|"~     Evaluate the safety and immunogenicity of four different doses of H7N9 vaccination in adults~     between the ages of 18 years and 65 years.~   "
125218|NCT01928459|"~     To study the safety and efficacy of the combination of BGJ398 with BYL719 in patients whose~     tumors express mutations to PIK3CA with or without alterations to FGFR 1-3.~   "
125219|NCT01928446|"~     Observational evidence and findings from clinical trials conducted for other reasons suggest~     that lithium, a drug used for the treatment of bipolar disorder, and, to a lesser extent,~     depression, may reduce rates of suicides and suicide attempts. However, this hypothesis has~     not yet been adequately examined in a randomized clinical trial conducted specifically to~     test lithium's efficacy in preventing suicides. This clinical trial fills this gap.~      This study is feasible within the Department of Veterans Affairs (VA) because it is a large,~     integrated health system with existing programs for identifying patients at risk for suicide~     and delivering enhanced services. In VA, approximately 12,000 patients with depression or~     bipolar disorder survive a suicide attempt or related behavior each year, and 15% of them~     repeat within one year. Experimental treatment in this study will supplement usual care for~     major depression or bipolar disorder, as well as VA's standard, enhanced management for~     patients at high risk.~      The investigators will recruit 1862 study participants, from approximately 30 VA Hospitals.~     Participants will be patients with bipolar disorder or depression who have survived a recent~     episode of suicidal self-directed violence or were hospitalized specifically to prevent~     suicide. Randomly, half will receive lithium, and half will receive placebo. Neither the~     patients nor their doctors will know whether a particular person has received lithium or~     placebo. The treatment will be administered and the patients will be followed for one year,~     after which patients will go back to usual care. Recruitment will occur over 3 years.~      The investigators are primarily interested in whether lithium leads to increases in the time~     to the first repeated episode of suicidal behavior, including suicide attempts, interrupted~     attempts, hospitalizations specifically to prevent suicide, and deaths from suicide. In~     addition, this study will allow us to explore whether lithium decreases the total number of~     suicidal behaviors, and whether it has comparable effects on impulsive and non-impulsive~     behaviors. If there is an effect of lithium, the investigators will be interested in whether~     or not it could be attributed to improved control of the underlying mental health condition,~     or, alternatively, whether it represents a direct effect of suicide-related behavior.~   "
125220|NCT01928433|"~     The primary objective of this study is to evaluate the microbiological and clinical outcome~     of treatment with finafloxacin for 5 days versus finafloxacin for 10 days versus~     ciprofloxacin for 10 days as a reference comparator.~      Finafloxacin shows increased activity in an acidic environment which is associated with~     indications such as uUTI and cUTI. Given the acidic pH of urine and concentration of~     finafloxacin excreted via the urinary tract in humans it should be proven if the finafloxacin~     treatments offer significant advantages over the currently available treatments for UTI.~   "
125221|NCT01928420|"~     The purpose of this study is to evaluate the safety and efficacy of NIC5-15 in the treatment~     of Alzheimer's Disease.~   "
125222|NCT01928407|"~     A phase IV, prospective, multicenter , randomized open label, 48 weeks study to evaluate the~     antiretroviral efficacy and safety of atazanavir/ritonavir or darunavir/ritonavir, each in~     combination with a fixed dose of tenofovir disoproxil fumarate- emtricitabine in~     HIV-1-infected treatment-naïve subjects with CD4 counts below 200 µL.~   "
125223|NCT01928394|"~     ADDENDUM- PLEASE NOTE: AS OF JANUARY 2017, THIS STUDY IS ONLY RECRUITING PATEINTS WITH~     BLADDER AND PANCREATIC CANCER. To investigate the safety and efficacy of Nivolumab as a~     single agent or in combination with Ipilimumab in 6 tumor types - triple-negative breast~     cancer (TNBC), gastric cancer (GC), pancreatic adenocarcinoma (PC), small cell lung cancer~     (SCLC), bladder cancer (BC), and ovarian cancer (OC). A combination of Nivolumab with~     Ipilimumab and Cobimetinib is also investigated in PC.~   "
125224|NCT01928381|"~     This is a 2-part study. In Part 1 of the study, subjects will undergo a pain reporting~     training program in which a painful stimulus will be applied to the subject's hand, and the~     subjects will be asked to report how painful the stimulus is. Over the course of the pain~     training sessions, feedback will be provided to the subject about how accurately they are~     reporting their degree of pain, relative to the amount of pressure stimulus applied to evoke~     pain. Those subjects who have adequate pain reporting ability will be asked to continue into~     Part 2 of the study in which 3 different blinded study drugs will be administered to each~     subject, in a crossover design to compare whether or not the study drugs improve pain~     associated with diabetic neuropathy.~   "
125225|NCT01928368|"~     The purpose of this study is to determine if a single dose of AMG 282 is safe in healthy~     subjects and subjects with mild atopic asthma.~   "
125235|NCT01928238|"~     The purpose of this study is to compare inspiratory effort, comfort, gas exchange and patient~     ventilator synchrony during non-invasive neurally adjusted ventilatory assist or~     pneumatically triggered and cycled-off noninvasive pressure support ventilation (NPSV), in~     patient at risk of respiratory distress after extubation.~   "
125236|NCT01928225|"~     Cervical cancer occurs commonly in HIV-infected women in South Africa. These women have poor~     response to treatment of cervical cancer precursors. This study will test whether giving the~     quadrivalent vaccine to women prior to surgical treatment of the cervical cancer precursor~     will improve outcomes. We hypothesize that pre-treatment HPV vaccine will result in a reduced~     occurrence or cervical cancer precursors in follow-up.~   "
125302|NCT01927354|"~     Investigation of the molecular mechanism and clinical significance of the interplay between~     Twist1 and other EMT regulators through microRNA-29 family.~   "
125226|NCT01928355|"~     There is some evidence to suggest that obesity is a risk factor for the development of~     cognitive dysfunction, although this is not a universal finding. This discordance might be~     ascribed to the existence of a 'healthy obese phenotype'- that is, obesity in the absence of~     metabolic risk factors. We examined whether the association of obesity with cognitive~     dysfunction is dependent on the individual's metabolic health.~      60 obese patients' undergoping liver fibroscan and blood tests will be enrolled. Obesity was~     defined as body mass index ≥ 30 kg/m2. Based on blood pressure, HDL-cholesterol,~     triglycerides, glycated haemoglobin, and C-reactive protein, participants were classified as~     'metabolically healthy' (0 or 1 metabolic abnormality) or 'unhealthy' (≥ 2 metabolic~     abnormalities). Cognitive dysfunction will be assessed by moca and minimental score. Results:~     Cognitive dysfunction prevalence is expected in 30% , but 50% of this group was categorized~     as metabolically healthy. Relative to non-obese healthy participants, after adjustment for~     baseline covariates, the metabolically unhealthy obese participants had elevated risk of~     cognitive dysfunction although the metabolically healthy obese did not. The association~     between obesity and risk of cognitive dysfunction appears to be partly dependent on metabolic~     health, although further work is required to confirm these findings.~      In obesity there is an increase in oxidative stress due to metabolic syndrome . Thus obese~     patients suffer from higher incidences of cardiovascular complications such as~     atherosclerosis as compare to non- obese population. Haptoglobin (Hp) is a plasma protein~     which binds free hemoglobin and prevents it from heme- iron mediated oxidation. There are~     three different types of Hp which differ in their antioxidant ability. Several clinical~     studies have shown that Hp 2-2 genotype is associated with higher incidence of cardiovascular~     diseases.~   "
125227|NCT01928342|"~     The purpose of this study is to evaluate the lipid lowering effects and clinical safety of a~     natural hypolipidemic compound, coenzyme A （CoA） capsule, combined use with statin, in~     Chinese patients with moderate dyslipidemia.~   "
125228|NCT01928329|"~     The goal of the proposed pilot study is to determine whether glucose control can be improved~     with Bydureon treatment in patients with type I diabetes (T1D)~   "
125229|NCT01928316|"~     The purpose of the study is to evaluate the bioequivalence (the way in which different forms~     of the same drug are absorbed in the body) of single-dose administration of domestic (made in~     China) mizolastine tablets and imported mizolastine tablets given at the same dose in healthy~     volunteers~   "
125230|NCT01928303|"~     This study will develop and test an algorithm that will estimate drug dosage from drug levels~     measured in oral fluid (saliva). Traditionally, urine has been used as the principle medium~     to monitor drug compliance in patients receiving opioids for chronic pain as well as those~     being treated for substance abuse. Recently, the use of saliva as an alternative to urine~     drug testing has been gaining in popularity. Oral fluid has several advantages over urine as~     a medium for drug screening. In this study, oral fluid, urine and blood specimens will be~     collected from volunteer patient donors with chronic pain taking opioid medications. Samples~     from the anonymous donor will be analyzed for opiate class drugs, using New York State~     Department of Health approved and validated laboratory methods. Analytical results and other~     information collected will assist in evaluating the use of oral fluid as a specimen to detect~     opiate drug levels. The measurement of drug concentrations in blood and oral fluid~     simultaneously will allow for the determination of the amount of oral fluid that will be~     needed for successful drug testing. It is proposed that by measuring oral fluid drug levels~     an estimate of the amount of drug taken will be possible.~   "
125231|NCT01928290|"~     This phase II trial studies how well combination chemotherapy works in treating patients with~     advanced stomach, gastroesophageal, or esophageal cancer. Drugs used in chemotherapy, such as~     irinotecan hydrochloride, oxaliplatin, leucovorin calcium, and fluorouracil, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor~     cells.~   "
125232|NCT01928277|"~     The main objective of the study is to examine the extent of agreement between patient and~     health care provider assessments of work of breathing and the association of agreement with~     demographic- and disease-related factors.~   "
125233|NCT01928264|"~     We will conduct a randomized control trial to investigate whether and to what extent regular~     and guided group physical activity over 12 weeks (2 sessions à 1 hour/week) improves physical~     fitness and (physio-)psychological functions (like subjective sleep, mental toughness,~     perceived stress, self-efficacy, etc.), as well as participation skills and the ability to~     work, in claimants for a disability pension due to psychiatric disorders, whose ability to~     work had recently been assessed by means of a psychiatric expert opinion. The control group~     is designed very similar and implies predominantly sedentary leisure time group activities~     (e.g. playing board games, doing handicrafts). Measures will be performed at baseline,~     post-test, and at follow ups three and twelve months after post-test, some variables will~     additionally be assessed 4-weekly during the intervention. We expect that intervention group~     participants will report and show, respectively, more improved physical fitness,~     (physio-)psychological functioning and participations skills, as well as increased ability to~     work, compared to the control group.~   "
125234|NCT01928251|"~     According to the Census & Statistics Department (2011), there are still 659,300 daily smokers~     (11.1%) in Hong Kong. Smoking and passive smoking kill over 7,000 people per year. Smoking is~     addictive, and it is difficult for some motivated smokers to quit without assistance. On the~     other hand, many smokers may not be ready to quit or want to quit on their own, so it is~     difficult to reach them.~      Quit and Win programme is an opportunity to reach and encourage a large group of smokers to~     make quit attempt. Quit and Win Contest assumes that smokers can develop a higher motivation~     to quit and gain a wider social support in quitting. According to Cahill and Petera (2011),~     smokers can develop a high motivation to quit and gain a wider social support through~     participating in the Quit and Win Contest.~      The Hong Kong Council on Smoking and Health (COSH) organized three Quit to Win Contests and~     recruited over 3000 smokers from 2009-2012. These events enhanced the motivation and~     confidence to quit smoking. Lucky draw was also conducted to attract smokers to quit smoking~     and winners were validated by biochemical tests.~      Community-Based Participatory Research (CBPR) is an partnership approach that can enlighten~     and utilize the network within communities as community partners can obtain ample manpower~     and social resources. To effectively raise the awareness of the contest and recruit as many~     participants as we can from the community, working with NGOs in the 18 Hong Kong districts~     with a CBPR model may be one effective way of program implementation.~      Thus, we proposed to (1) test the effectiveness of combining competition and short-term~     monetary incentives to motivate smokers who participate in the Quit to Win Contest 2013 to~     quit smoking; (2) use a Community-Based Participatory Research (CBPR) model to build capacity~     and to engage community partners in taking on this important public health issue for~     sustainability in the community; and (3) conduct the process evaluation to assess the~     effectiveness of the recruitment activity and how it is linked with the overall program~     outcomes.~      Hypothesis:~      To examine the effectiveness of the interventions, three arms are (i) Group A: Informed early~     monetary incentive, which participants will be notified of the incentive through telephone~     follow-up at 1-week and 1-month follow-ups; (ii) Group B: Uninformed early monetary~     incentive, which participants will not be informed about the incentive until 3-month~     telephone follow-up; (iii) Group C (control group): Uninformed late monetary incentive, which~     participants will not be informed about the incentive throughout 1-week, 1-month and 3-month~     follow-ups.~      The primary outcomes are the self-reported 7-day point prevalence (pp) quit rate at 3 months~     of group A compared to group B and group C. The secondary outcomes include (i) self-reported~     7-day point prevalence (pp) quit rate at 6 months, (ii) biochemical validated quit rates,~     (iii) rate of smoking reduction by at least half of baseline amount, (iv) number of quit~     attempts at 3 and 6 months among the three groups and (v) the above cessation outcomes of all~     subjects, including or not including in the RCT.~   "
125303|NCT01927341|"~     The primary purpose of the phase Ib is to estimate the MTD/RPD2 and of the phase II is to~     assess the anti-tumor activity of MEK162 in combination with panitumumab.~   "
125237|NCT01928212|"~     Optical coherence tomography (OCT) is a non-invasive retinal imaging technology that can~     provide high-resolution cross-sectional images of the peripapillary retinal nerve fiber layer~     (RNFL) and measure its thickness. A reduction of the RNFL thickness has been detected in~     several neurodegenerative diseases, such as multiple sclerosis, CADASIL and Alzheimer's~     disease. Different studies have reported RNFL changes also in Parkinson's disease (PD),a~     common neurodegenerative disease characterized by motor dysfunctions, originally described by~     James Parkinson in 1817. PD is characterized by selective dopaminergic neuronal cells loss,~     which may correlate with RNFL thinning. Previous studies on this subject, however, reported~     contradicting results. Some investigations reported reductions of the RNFL thickness while~     others did not. In the present study, in order to determine whether RNFL thickness is reduced~     in PD patients, we performed a meta-analysis and systematically evaluated RNFL thickness~     measurements with OCT in a series of PD patients and in the healthy control groups.~   "
125238|NCT01928199|"~     The purpose of this study is to determine whether sitagliptin is effective in preventing the~     development of new-onset diabetes after kidney transplant (NODAT). Up to one-third of~     previously non-diabetic patients develop NODAT after a kidney transplant. Corticosteroids and~     calcineurin inhibitors are two commonly utilized anti-rejection medications that contribute~     to diabetes development through multiple mechanisms; including decreased insulin production~     by the pancreas. Sitagliptin is an oral medication that results in increased insulin~     secretion. We hypothesize that administration of sitagliptin to transplant recipients~     identified to be at risk for diabetes development will reduce the incidence and severity of~     NODAT.~   "
125239|NCT01928186|"~     This clinical trial studies fluorine F 18 fluorothymidine (FLT) positron emission tomography~     (PET) in measuring treatment response in patients with newly diagnosed estrogen receptor~     (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage I-III breast~     cancer. Comparing results of diagnostic procedures done before and during hormone therapy may~     help doctors predict a patient's response to treatment and help plan the best treatment.~   "
125240|NCT01928173|"~     The purpose of this study is to test the effectiveness of a 1-session abbreviated~     cognitive-behavior therapy for insomnia among college students. The investigators will~     examine the following hypotheses in the present study: 1) Viewing the treatment video will~     produce an increment in sleep knowledge relative to baseline and minimum treatment control;~     and 2) Viewing the treatment video will result in improved sleep relative to baseline and~     minimum treatment control.~      Students who self-identify as having insomnia will be recruited from the University of~     Alabama's Psychology subject pool. Students who enroll in the study will receive a link to~     the demographic and screening questionnaire. Individuals who have a history of other sleep~     disorders or who currently present with symptoms strongly suggestive of sleep disorders, such~     as obstructive sleep apnea or narcolepsy will be excluded. Individuals who are shift-workers~     and those with a history of severe mental illness will also be excluded.~      Participants who meet criteria for this study will then be directed to complete a measure of~     sleep knowledge. Once they have completed the measure of sleep knowledge, they will be~     directed to complete the Consensus Sleep Diary (CSD) for 14 days as soon as possible after~     awakening in the morning. During the second week of completing the CSD, participants will be~     directed to complete the Insomnia Severity Index and the Patient-Reported Outcomes~     Measurement Information System Sleep Disturbance and Sleep-Related Impairments Short Forms on~     the last day they complete a CSD.~      Participants will be randomized to a treatment group or a minimum treatment control group~     upon completion of these baseline measures. Those in the treatment group will be emailed the~     following components of the insomnia treatment: a link to the treatment video, an mp3 file~     with a relaxation recording, and a pdf file of a brochure reviewing the information presented~     in the treatment video. Participants will be asked to view the treatment video and begin~     practicing the relaxation technique presented in the mp3 file as soon as possible.~     Participants in the minimum treatment control group will receive a link to a sleep education~     video.~      Two weeks after participants have viewed the videos, they will be asked to complete~     post-treatment measures in the same sequence as they did at baseline. One month after the~     post-treatment measures have been completed, both groups will be asked to complete the same~     measures again for follow-up.~   "
125241|NCT01928160|"~     This randomized phase II trial studies how well pemetrexed disodium and carboplatin or~     cisplatin with or without erlotinib hydrochloride work in treating patients with epidermal~     growth factor receptor (EGFR) mutant positive stage IV non-small cell lung cancer and~     acquired resistance to first-line therapy with erlotinib hydrochloride or gefitinib. In~     patients that develop resistance to first-line therapy with EGFR tyrosine kinase inhibitors~     (TKIs) the drug is usually stopped and the patient is switched to chemotherapy. Drugs used in~     chemotherapy, such as pemetrexed disodium, carboplatin, and cisplatin, work in different ways~     to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth. It is not yet known whether pemetrexed disodium and~     carboplatin or cisplatin is more effective with or without erlotinib hydrochloride in~     treating patients with EGFR mutant non-small cell lung cancer and acquired resistance to EGFR~     TKIs.~   "
125242|NCT01928147|"~     PPI-383 is an antiviral agent (an inhibitor of the hepatitis C virus NS5B polymerase) that is~     being developed as a potential treatment for hepatitis C virus infection. This study is being~     done to assess the dose-related safety and tolerance of PPI-383 when given to healthy~     volunteers for up to 5 days (Part I of the study) and to hepatitis C patients for up to 3~     days (Part II). In addition, the study will assess how much PPI-383 is absorbed into the~     bloodstream. In Part II, the dose-related effect of PPI-383 on the amount of hepatitis C~     virus in patients' bloodstream (serum HCV RNA levels) also will be assessed.~   "
125243|NCT01928134|"~     This study used the generally recognized as safe (GRAS) grade of Bacillus subtilis natto to~     produce Vitamin K2, Menaquinone-7(MK-7), via fermentation, for functional evaluation. There~     are four major objectives for this study: (1) bioavailability of calcium; (2) evaluation of~     bone density improvement; (3) evaluation of blood-vessel calcification and sclerosis~     improvement; (4) safety evaluation.~   "
125244|NCT01928121|"~     The purpose of this study is to assess the effectiveness of a newly developed~     interdisciplinary nurse-coordinated AF expert program for primary care patients. Therefore a~     prospective, pragmatic clustered randomized controlled trial will be performed in general~     practices.~   "
125245|NCT01928108|"~     The purpose of this investigation is to prospectively evaluate the benefit of different~     methods of educating patients regarding their fluid intake through a readily available daily~     cellular phone application to improve overall urine output and reduce risk factors for stone~     recurrence.~   "
125246|NCT01928095|"~     The research objectives of this project are as follows:~        1. Obtain high-quality human atherosclerotic arterial samples from diseased donors.~        2. Perform biochemical analysis to determine the abundance, localization and activity of~          Dicer and double-stranded RNAs in these diseased tissues.~   "
125247|NCT01928082|"~     The purpose of this study is to assess if estrogen replacement normalizes urinary calcium~     excretion in postmenopausal women with hypercalciuria and low bone mass and to assess for~     differences in response to estrogen replacement in women with familial hypercalciuria~     compared to nonfamilial hypercalciuria.~   "
125249|NCT01928056|"~     Objective:~      Primary objective of the present study was to compare the single dose bioavailability of~     Torrent's Montelukast Sodium 10 mg tablet and Innovator's(Merck)Singulair 10 mg tablet.~     Dosing periods were separated by a washout period during fasted study.~      Study Design:~      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence~     Study~   "
125250|NCT01928043|"~     This study will enroll 30 adolescents with bipolar disorder (BD) who are suffering from~     symptoms of depression despite already taking a traditional mood-stabilizing medication.~     Curcumin will be added to their current medications for 8 weeks. During these 8 weeks, their~     mood symptoms will be assessed regularly. Height, weight, and blood pressure will also be~     measured repeatedly. Blood tests will be completed before treatment, after 4 weeks of~     treatment, and at the end of the study. Blood tests will allow us to determine whether~     changes in inflammation and oxidative stress explain curcumin's effect on mood. Finally, we~     will use sophisticated technology to measure blood vessel functioning. We have three main~     predictions: 1. Curcumin will improve mood symptoms without causing physical problems; 2.~     Curcumin will reduce inflammation and oxidative stress, and these reductions will be linked~     to improvements in mood; 3. Curcumin will improve blood vessel functioning, and these~     improvements will be linked to improved inflammation and oxidative stress.~   "
125251|NCT01928030|"~     This phase 1-2 trial studies the side effects and the best dose of recombinant human~     hyaluronidase and to see how well it works in treating lymphedema in patients with cancer.~     Recombinant human hyaluronidase (r-hu-hyaluronidase, rHuPH20) may reduce limb edema size in~     patients with lymphedema.~   "
125252|NCT01928017|"~     This is a prospective observational clinical study to characterise abnormalities of~     thromboelastography (TEG) parameters in patients with chemotherapy-induced thrombocytopenia.~     The investigators are also studying the relationship between Multiplate analysis and bleeding~     in these patients and the effect of platelet transfusions on thrombopoietin level and percent~     reticulated platelets.~      The investigators' hypothesis is that changes in TEG-parameters reflect the patients tendency~     to bleed.~   "
125253|NCT01928004|"~     The purpose of this study is to investigate denture satisfaction following the conversion of~     existing mandibular complete dentures to implant-overdentures (IOD) in very old edentulous~     patients who depend on help for activities of daily living (ADL) and evaluate secondary~     endpoints such as functional, structural, nutritional, cognitive and patient-centered outcome~     measures.~   "
125254|NCT01927991|"~     Internet-based cognitive behavioural self-help (iCBT) has become increasingly popular to~     provide psychotherapy. For several psychological and psychosomatic disorders, treatment~     efficacy was shown. Previously, iCBT has also been applied to patients suffering from~     tinnitus and results show significant and long-term stable improvements in tinnitus distress.~     However, the role of therapeutic support in iCBT has not been thoroughly investigated.~     Previous results suggest that iCBT without therapeutic support is less effective and leads to~     higher dropout rates than therapist-guided iCBT. The aim of the randomized controlled trial~     is thus to investigate the role of therapeutic support in an iCBT for tinnitus sufferers.~   "
125255|NCT01927978|"~     This study is aimed to evaluate the effectiveness of 18F-FDG PET in the initial staging,~     therapy planning, and therapeutic response monitoring for esophageal cancer patients.~      Purpose:~        1. The incremental staging information by using 18F-FDG PET~        2. The impact of the PET results on the patients' subsequent therapy planning~        3. To compare treatment response using RECIST criteria and FDG PET results.~   "
125256|NCT01927965|"~     The primary objective of this study is to determine the maximum tolerated dose (MTD) and the~     dose limiting toxicities (DLT) of Minnelide™ and to establish the dose of Minnelide™~     recommended for future phase 2 protocol~   "
125257|NCT01927952|"~     The purpose of this research project is to compare three different methods for fixation of~     hammertoe deformities: (1) Kirschner wire; (2) Integra IPP-ON PIP Fusion System; and (3)~     Stryker Smart-Toe implant.~   "
125258|NCT01927939|"~     This study is to evaluate the effectiveness of 18F-FDG PET in following up of metastastic~     bone lesions and in predicting outcome for breast cancer patients after therapy.~      Primary outcome: Using 18F-FDG uptake to evaluate the metastatic bone status after treatment.~     The PET results will be compared with the results in Tc-99m MDP bone scintigraphy.~      Secondary outcome: Evaluate the relationship between the 18F-FDG uptake of the metastatic~     bone lesions and (1) breast cancer related tumor marker, (2) patients' survival.~   "
125259|NCT01927926|"~     Developing functional foods that enhance satiety may be beneficial to individuals to help~     manage body weight.~      We have previously shown that consuming a mid-morning liquid preload with increasing~     proportion of energy derived from whey protein and addition of polydextrose reduced voluntary~     energy intake at a lunchtime meal compared to a liquid preload of the same energy content but~     lower in protein and containing no polydextrose.~      This study aims to investigate if these results can be replicated when the preload is in the~     form of a snack bar. We will also investigate whether the daily consumption of the snack bar~     has an effect on energy intake, subjective appetite and metabolic parameters compared to a~     control snack of the same energy but with a minimal protein content and without the addition~     of polydextrose.~      We hypothesize that the whey protein polydextrose snack will reduce voluntary energy intake~     at a subsequent test meal, suppress subjective appetite ratings compared with the control~     snack bar.~   "
125260|NCT01927913|"~     The purpose of this open-label study is to assess liver iron concentration using MRI imaging~     in subjects with beta-thalassemia when administered with either SPD602 or deferasirox for the~     treatment of chronic transfusional iron overload.~   "
125261|NCT01927900|"~     The study is a randomised, placebo-controlled, double-blind, parallel, dose-finding study~     with healthy volunteers. A total of 100 male and female volunteers will be included. The~     volunteers will be randomized into one of 10 groups, each of 10 participants, consuming~     either active product in various mixes and doses (9 groups) or placebo product (1 group) for~     2 weeks. The 9 groups receiving active product will receive either one of two Human Milk~     Oligosaccharides (HMOs) alone or in combination at different doses. The primary purpose of~     the study is establishing the effects of various compositions and doses of HMOs on the faecal~     flora and on gastrointestinal symptoms in health adults.~   "
145512|NCT01662531|"~     This study will examine the pharmacokinetics, safety and efficacy of rIX-FP for the control~     and prevention of bleeding episodes in children who have previously received factor~     replacement therapy for hemophilia B.~   "
125262|NCT01927887|"~     The purpose of this research study is to see if a specific kind of MRI can identify small and~     otherwise undetected abnormal lymph nodes in patients with thyroid cancer who are undergoing~     surgery. The MRI is called Ultra-Small Superparamagnetic Iron Oxide Magnetic Resonance~     Imaging (USPIO MRI), and uses an experimental contrast agent (ferumoxytol), to try to~     identify these lymph nodes. The MRI uses magnetic waves to take images (pictures) of the body~     and is commonly used in medical testing.~      Ferumoxytol is FDA approved as an iron replacement product for the treatment of iron~     deficiency anemia in adult patients with chronic kidney disease.~      In this research study, the investigators want to see if Ferumoxytol will help to identify~     very small metastases that are not usually seen on standard MRI scans. If the use of USPIO~     MRI with the experimental agent ferumoxytol identifies very small metastases in lymph nodes,~     your surgeon may decide to remove them. After the surgery, the nodes will be stored and then~     analyzed to assess the ability of USPIO MRI and ferumoxytol to detect cancer in very small~     metastases in the lymph nodes.~   "
125263|NCT01927874|"~     There will be compared the postoperative analgesic effect of infiltration or spinal block for~     hemorrhoidectomy~   "
125264|NCT01927861|"~     This trial is conducted in Asia. The aim of the trial is to investigate the long-term~     efficacy and safety of two doses of NN-220 (somatropin) in short stature due to Noonan~     syndrome.~   "
125265|NCT01927848|"~     Knee related mobility limitations are the leading cause of disability in the western world.~     It is a very expensive and debilitating condition when the cost of lost productivity and~     personal assistance is considered.~      In recent years there has been a growing interest in alternative medicine and many~     individuals seek such treatments. Rosehip, that is sold as a nutritional supplement, has been~     particular popular, and has been shown effective in relieiving pain - albeit the evidence is~     scarce.~      The purpose of this study is to evaluate the efficacy of specialized rosehip powder~     nutritional additives (Rosenoids®) on knee joint function during walking in subjects with~     knee-related walking limitations.~   "
125266|NCT01927835|"~     The purpose of this study is to evaluate the safety and immune response to two different HIV~     vaccine regimens in healthy, HIV-uninfected people in the United States and South Africa.~   "
125267|NCT01927822|"~     This study aims to analyze the factors influencing the abortion interval of second-trimester~     termination of pregnancy using misoprostol.~   "
125268|NCT01927809|"~     Hirschsprung's disease is a complex genetic disorder. The etiology of this disease is not~     completely understood. It is characterized by the absence of ganglia (nerve cells) in de~     distal colon. This impairs bowel relaxation which can lead to bowel disfunction, toxic~     megacolon, ileus and enterocolitis. So far, several genes have been identified that play a~     role in Hirschsprung's disease. The precise mechanisms however, remain unclear. This study~     wants to identify new mutations and hopefully clarify more about the etiology of the disease.~   "
125269|NCT01927783|"~     Background:~      - Past studies suggest that the best way to improve heart health in the Black community is~     through community-based programs. Researchers will partner with DC community leaders. They~     will collect information about the health and health needs of people in mostly Black churches~     in DC. They will study things that affect heart health, like diabetes, blood pressure,~     cholesterol, and weight. They will also study how technology can keep track of activities and~     health. The information will show the health needs of this church-based community.~      Objectives:~      - To create an intervention for future programs to improve heart health in African-American~     churches in Washington, DC.~      Eligibility:~      - Adults ages 19 to 85 who attend one of the study churches.~      Design:~        -  Participants will visit their church for a 4-hour health exam. They will have their~          blood pressure and body measurements taken. They will have a drop of blood taken from~          their finger with a small needle. This blood will be tested for blood sugar and~          cholesterol. Participants will be given the results of these tests.~        -  Participants will answer questions about their health.~        -  All participants will be given an activity monitor to wear for 1 month. The activity~          monitor is worn around the wrist. Some participants will also receive an activity~          monitor that is worn around the waist. Participants will be given instructions on how to~          wear the activity monitors and follow the results on a website.~        -  At the end of 1 month, participants will return one device (they can keep the other).~          They may receive a gift card for completing the study.~   "
125270|NCT01927770|"~     Background:~      The purpose of this study is to investigate the process of consenting participants to whole~     exome/genome sequencing and its outcomes. It is unknown how best to consent people to this~     new technology. NO GENOME SEQUENCING IS OFFERED AS PART OF THIS STUDY. This protocol is a~     companion to other NIH studies that involve genomic sequencing. Participants must be enrolled~     in a parent NIH study that is collaborating on this consent study to be eligible. Currently~     this involves only one NIH study.~      Objectives:~      - To learn the best way to help participants understand sequencing, so they can decide~     whether to join studies that use it.~      Eligibility:~        -  Adults at least 18 years old who are enrolled in a National Institutes of Health (NIH)~          study that uses WES/WGS.~        -  Adults at least 18 years old whose children are enrolled in an NIH study that uses~          WES/WGS.~      Design:~        -  Participants will take part in the study either in person or over the phone.~        -  Participants will review two sequencing consent forms with a genetic counselor.~        -  Before and after meeting with the counselor, participants will answer several questions~          about sequencing. Each questionnaire will take about 15 minutes.~        -  Six weeks later, participants will answer questions about sequencing. This will take~          about 15 minutes.~   "
125271|NCT01927757|"~     To evaluate the efficacy of etanercept in adults with moderate-to-severe rheumatoid arthritis~     (RA) who did not respond to or lost a satisfactory response to adalimumab when used as their~     first biologic agent.~   "
125304|NCT01927328|"~     40 eligible patients with confirmed esophageal or gastric adenocarcinoma and anemia will be~     randomized to a control or intervention group for management of this anemia. The control~     group treatment will consist of standard treatments as governed by the clinical team (eg oral~     iron, blood transfusions) whilst the intervention group will be treated with intravenous iron~     III isomaltoside (Monofer ®).~      It is hypothesized that intravenous iron supplementation is more efficacious than standard~     therapies.~   "
125272|NCT01927744|"~     The goal of this clinical research study is to learn if adding erlotinib to a standard~     chemotherapy combination (docetaxel and either cisplatin or carboplatin) can help to control~     SCCHN. The safety of this drug combination will also be studied.~      In this study, erlotinib will be compared to a placebo. A placebo is not a drug. It looks~     like the study drug but is not designed to treat any disease or illness. It is designed to be~     compared with a study drug to learn if the study drug has any real effect.~      This is an investigational study. Erlotinib is approved by the FDA for treatment of non-small~     cell lung cancer. Its use in this study is experimental. Docetaxel, cisplatin, and~     carboplatin are all FDA approved and commercially available for the treatment of SCCHN.~      Up to 100 patients will take part in this study. All will be enrolled at MD Anderson.~   "
125273|NCT01927731|"~     The goal of this clinical research study is to learn if taking Promacta (eltrombopag) will~     help your platelet count improve faster after your stem cell transplant. The safety of this~     drug will also be studied.~      This is an investigational study. Eltrombopag is FDA approved and commercially available for~     the treatment of low platelet counts in patients with idiopathic thrombocytopenic purpura~     (ITP -- a severe bleeding disease). Its use in patients with low platelet counts after a stem~     cell transplant is investigational.~      Up to 60 patients will take part in this study. All will be enrolled at MD Anderson.~   "
125274|NCT01927718|"~     The goal of this clinical research study is to learn if adding low dose Thalidomide~     (thalidomide) to Revlimid (lenalidomide) maintenance therapy will help control MM after an~     autologous stem cell transplant. Researchers also want to learn if treatment with these study~     drugs will improve participants' quality of life.~   "
125275|NCT01927705|"~     The purpose of phase I clinical trial is to evaluate safety and efficacy in subjects with~     over Moderately subacute and chronic Atopic Dermatitis after inject. Also, The purpose of~     phase IIa clinical trial is to determine clinically proper dose capacity of FURESTEM-AD Inj.~     by evaluating safety and efficacy based on SCORAD INDEX in subjects with over Moderately~     subacute and chronic Atopic Dermatitis.~   "
125276|NCT01927692|"~     The primary objective of the study is to longitudinally profile immunoglobulin levels and~     autoantibody levels in subjects with myasthenia gravis (MG) who receive therapeutic plasma~     exchange (TPE).~   "
125277|NCT01927679|"~     The main objective of the study is to assess the efficacy of an antioxidant in preventing~     pigmentation induced by visible light in subjects with a phototype IV or V.~      Patients will be exposed to a range of visible light to areas on the back to confirm study~     eligibility. Patients showing pigmentation after 7 days on the exposed areas will be eligible~     to continue.~      Eligible patients will have study product applied to part of the back and placebo on another~     part of the back. The placebo area will be exposed to the same range of light based as at Day~     -7. The area where the antioxidant is applied will have a higher range of light exposure than~     the area without the study product.~      Seven days later, the areas will be examined to determine the lowest exposure inducing~     pigmentation on the sides with placebo and with antioxidant. The color will also be measured~     between two identical exposures with placebo and with antioxidant.~   "
125278|NCT01927666|"~     The variation in extent of isothiocyanate (ITC) excretion in urine from a capsule delivered~     dose of glucoraphanin will correlate with differences in (a) the gut microbiota, and (b) the~     genotype of key polymorphic genes (GSTM1, GSTT1, and other as yet undetermined candidate~     genes).~      Our study is a human dietary intervention in which participants will consume one capsule~     containing 100mg purified glucoraphanin from broccoli. The levels of glucoraphanin delivered~     by the capsule are similar to one to two portions of broccoli. As this is purified~     glucoraphanin there is no myrosinase enzyme present. All conversion of the glucoraphanin,~     contained within the capsule, to ITC will therefore occur by enzymes found in the gut~     microbiota.~      The ability of the glucoraphanin in the capsule to be metabolised to ITCs by the gut~     microflora is unknown and will be assessed by measuring ITCs excreted in the urine. The ITCs~     will be quantified in urine using validated analytical methods.~      It has been shown in human dietary intervention studies that the extent of conversion of~     glucosinolates varies greatly. In order to assess possible causative factors for variation in~     rate of glucoraphanin metabolism each participant will provide a faecal sample from which~     their faecal gut microbiota phylogeny will be analysed.~      For a small number of participants a second faecal sample will be requested (a maximum of 3~     participants). It is our aim to select one low, one medium and one high ITC excreter. Ideally~     the low and high excreters would be within the lowest and highest 5% excretion of ITC and the~     third participant would be as close to the mean ITC excretion as possible. The aim would be~     to culture the faecal microbiota over time with repeat dosing of glucoraphanin in order to~     select for microbiota that are able to metabolise glucoraphanin. It is known that the main~     hydrolysis product of glucoraphanin, sulforaphane, has a variety of benefits to human health,~     however there is no known clinical relevance to being a high, medium or low excreter of ITC.~      For each participant a blood sample will also be requested in order that we can assess~     whether genotype affects the rate of ITC excretion in urine. The GSTM1 genotype and other, as~     yet, unidentified candidate genes of each participant will be determined. Whether the~     genotype affects the rate of ITC excretion either alone or in combination with the~     phylogenetic profile will be assessed.~   "
125279|NCT01927653|"~     The hypothesis tested if the diffusion properties in the base line, such as mean diffusivity~     or kurtosis, can differentiate two subtypes of MCI and predict the clinical outcome in~     Patients. The hypothesis further supports the correlation of the measured diffusion~     properties and the disease severity. We therefore proposed to investigate the potential value~     of diffusion properties as a possible tool to monitor the disease progression. The disease~     related changes in neural connectivity will be investigated.~        1. The diffusion MRI could provide an improved diagnosis of Alzheimer's Disease and Mild~          cognitive Impairment.~           Explanation:~           The deposition of the macromolecules such as beta amyloid in the brain and the~          associated neuron death of the patient could lead to observable changes in tissue~          microenvironment. The related changes would lead to alterations in either the amplitude~          or distribution of water diffusion. In turn it could be detected in diffusion tensor and~          kurtosis.~        2. aMCI is a preclinical state of AD and dMCI is from a different etiology, which can be~          differentially diagnosis by MRI. Diffusion Imaging could help to predict the clinical~          outcome Explanation~   "
125280|NCT01927640|"~     This study will use myocardial contrast echocardiography performed during a continuous~     intravenous infusion of Definity microbubbles (Perflutren lipid microbubbles) to determine if~     dexmedetomidine (an intravenous central sympatholytic drug) can reverse all the~     cardiovascular effects of low-dose intranasal cocaine—including vasoconstriction in the~     coronary microcirculation—both in cocaine-naïve and non-treatment seeking cocaine-addicted~     subjects.~   "
125281|NCT01927627|"~     The purpose of this study is to see how long it takes for prostate cancer to come back in~     patients who have had surgery to remove their prostate gland (radical prostatectomy), while~     being treated with enzalutamide (formerly known as MDV3100).~      Enzalutamide is known as an androgen-receptor signaling inhibitor, which means that it blocks~     activity of the male hormone, testosterone. Most prostate cancers are dependent on~     testosterone for growth. In this study, patients will take enzalutamide after surgery to see~     if it keeps their cancer from coming back.~   "
125319|NCT01927133|"~     Mortality related to complications of cirrhosis, (hemorrhage, hepatic insufficiency and~     primary liver cancer) is 15,000 per year in France. These mortality increases, despite that~     advanced fibrosis can be identified by non-invasive biomarkers and treated, more than 10~     years before the onset of complications and cancer. The main goals of the FIBROFRANCE project~     which started in 1997 (initially called the MULTIVIRC group) were to demonstrate the~     performance of serum biomarkers in the more frequent chronic liver diseases, to estimate the~     dynamic of fibrosis progression and finally to demonstrate the feasibility of the fibrosis~     screening in French people.~      The different cohorts of the FIBROFRANCE (HCV, HBV, ALD, NAFLD) permitted many publications~     among the 186 publications of our group since 1986 in the field of liver fibrosis. These~     publications included discovery and validation of non-invasive biomarkers (Poynard~     Gastroenterology 1997, Imbert-Bismut Lancet 2001, Poynard BMC Gastro 2007), modelling~     fibrosis progression or regression (Poynard Lancet 1997, Poynard Gastroenterology 2002,~     Poynard J Hepatol 2003) and fibrosis screening (Ratziu APT 2007, Jacqueminet Clin~     Gastrenterol Hepatol 2008). This research was conducted in Pitié-Salpêtrière hospital for the~     biochemical and clinical part in connection with national and international networks. Several~     panels have been identified and the most predictive FibroTest has been patented (US Patent~     Office 6.631.330) and launched in 2002. This is the first fibrosis biomarker available~     worldwide (50 countries including USA as FibroSURE) with more than 1 million prescriptions~     between 2002-2013. FibroTest, has been validated first in hepatitis C and then in hepatitis B~     alcoholic liver disease and metabolic syndrome. Therefore it is now possible to screen~     advanced fibrosis in the 4 most frequent liver diseases: alcohol, hepatitis C and B, and~     metabolic syndrome (diabetes, overweight, and hyperlipemia). For all the patients detected~     there are therapeutic options to cure the fibrosis or to reduce the progression to cirrhosis~     and cancer.~      FibroTest has been recommended as alternative to biopsy in several guidelines (AFEF, APASL,~     EASL and CASLD) and more recently in US overview (Chou Annals 2013). It reimbursed in France~     in chronic hepatitis C. Several factors of fibrosis progression can be present in the same~     subject, i.e. an overweight and an excessive alcohol consumption. Therefore no realistic~     screenng strategy can be conducted without taking into account the Interdependence of the~     different risk factors. Three biomarkers of fibrosis-associated liver injuries have been~     developed and validated in FIBROFRANCE cohorts: SteatoTest for steatosis (Poynard Comp~     Hepatol 2005), NashTest for non-alcoholic steatohepatitis (Poynard EASL 2006), and AshTest~     for alcoholic steatohepatitis (Naveau J Hepatol 2006). For this purpose different cohorts~     already used for diagnostic validation will be followed at long term for prognostic~     validations: FIBROFRANCE-ALD (Naveau Hepatology 2010), FIBROFRANCE-NAFLD including~     dyslipidemia cohort (Ratziu APT 2007) and diabetes cohort (Jacqueminet Clin Gastrenterol~     Hepatol 2008). These cohorts will allow assessing the prevalence of fibrosis and the specific~     risks of fibrosis progression imputable to steatosis and steatohepatitis.~   "
125282|NCT01927614|"~     Cardiac allograft vasculopathy (CAV) is a process of both immune and non-immune mediated~     thickening of the heart arteries of transplanted hearts. CAV limits the long term survival of~     heart transplant patients and is one of the common causes of death in the late post~     transplant period. Current methods of detecting CAV rest with invasive cardiac~     catheterization which carry repeated risks, as this test needs to be performed periodically~     through the life of a heart transplant patient. Traditional methods of coronary angiography~     identify CAV late in its course and is a crude method of evaluating coronary anatomy in heart~     transplant patients. Intravascular ultrasound is an additive tool that is able to detect~     early CAV before it becomes angiographically apparent, but still requires invasive cardiac~     catheterization to perform. However, it also limits assessment to the major epicardial~     arteries and does not give any information regarding the smaller branch vessels and cardiac~     microvasculature. Advances in cardiac CT and cardiac MRI hold potential to evaluate for CAV~     non-invasively. In addition, perfusion techniques may provide additional functional~     information regarding the status of the microvascular.~      In this pilot study, we aim to demonstrate the feasibility of cardiac CT and cardiac MRI with~     and without perfusion protocols, in patients post-heart transplant and to describe and~     compare CT and MRI findings in patients with established CAV versus those with no CAV, as~     diagnosed by standard invasive methods.~   "
125283|NCT01927601|"~     The investigators seek to determine the feasibility of assessing neurologic injuries~     subsequent to transcathether aortic valve replacement (TAVR). Such a model has been applied~     previously by the principal investigator to assess and improve neurologic outcomes for other~     cardiac surgical procedures. The investigators shall assess patients during the following~     intervals: pre-procedure, within 72-96 hours post-procedure, and 3 months post-procedure.~     Case videos will be established to assist in identifying and associating emboli (using~     transcranial Doppler) and processes of clinical care during the TAVR procedure. Neurologic~     injury will be assessed in the following ways: stroke (neurologic exam, NIH Stroke Scale),~     silent infarcts (diffusion-weighted MRI, diffusion-tensor imaging), and neurobehavioral~     deficits (a battery of neuropsychological tests). Secondly, the investigators will~     investigate changes in the apnea-hypopnea index (AHI), a measure of sleep-disordered~     breathing, before vs after surgery between those subjects who develop post-operative acute~     brain infarction and those who do not. The investigators hypothesize that subjects who~     develop acute brain infarction will have an increase in AHI between baseline and post-op~     measurements compared with those subjects who do not develop acute brain infarction. A~     research coordinator will coordinate the testing.~   "
125284|NCT01927588|"~     CMV infection is common in transplant patients and can cause graft loss. CMV is a major~     factor in increasing morbidity, and post-transplant costs. The CMV infection is associated~     with many deleterious indirect effects including rejection, interstitial fibrosis and tubular~     atrophy, mortality. In addition to the potential for undesirable clinical outcomes associated~     with CMV, there is also a negative economic aspect. Patients who developed CMV events have~     been found to use significantly more inpatient and outpatient resources than patients without~     CMV disease. Universal prophylaxis is associated with high treatment cost and the potential~     for drug-related toxicity. It can be speculated that use of EVR may offer additional economic~     benefits in terms of decreased utilization associated with prevention of CMV disease, and~     reduce use of costly prophylaxis. Any efforts to reduce costs in renal transplants are very~     important and may have a great impact in total cost of a renal program. And the other hand,~     the clinical data suggest that EVR is associated with a decrease in CMV incidence compared to~     mycophenolic acid (MPA). CMV replication is dependent upon 1 ou 2 mTor pathways and in vitro~     studies support an association between mTor inhibitors and decreased CMV infection and~     disease. In cardiac transplantation, the use of EVR was associated with a lower incidence of~     CMV events. Some clinical trials data have also shown that use of EVR was associated with a~     lower incidence of CMV infection compared to MPA following renal transplantation. Brennan et~     al compared the incidence of CMV in three clinical trials using EVR versus MPA in De Novo~     renal transplants. They pooled for analysis the studies B201, B251 and A2309, all~     double-blind, randomized, parallel-groups that compared the incidence of freedom form and~     incidence of CMV between EVR groups and MPA groups. The results of this pooled analysis of~     over 2000 patients de novo renal transplant demonstrated that EVR was associated with a~     decrease in and delay in the time of onset of CMV events compared to MPA. Our hypothesis is~     that basiliximab in combination with low dose tacrolimus, everolimus and prednisone may~     result in comparable efficacy (BCAR) observed in patients receiving~     tacrolimus/mycophenolate/prednisone but with a better safety profile (CMV infection) and~     cost-effectiveness.~   "
125285|NCT01927575|"~     To acquire and build a library of image sets to determine if Fuji's TOMO imaging device can~     replace or compliment current imaging standards to assess patients with hip, wrist or tibia~     injuries.~   "
125286|NCT01927562|"~     The purpose of this study is to assess the safety and feasibility of the Fractyl Duodenal~     Remodeling System for the treatment of patients with poorly controlled Type 2 Diabetes.~   "
125287|NCT01927549|"~     The study compares the therapies of instant multivessel balloon angioplasty plus stent~     implantation or the balloon angioplasty plus stent implantation of the infarct artery alone~     with any possible graduated later treatment of the other vessels in patients with acute~     myocardial infarction with cardioganic shock.~      The main study hypothesis is to explore if culprit vessel only PCI with potentially~     subsequent staged revascularization in comparison to immediate multivessel revascularization~     by PCI in patients with cardiogenic shock complicating acute myocardial infarction reduces~     the incidence of 30- day mortality and/or severe renal failure requiring renal replacement~     therapy.~   "
125288|NCT01927536|"~     The investigators are testing a Light-emiting Diode (LED) flashlight from First-Light™ USA~     called the Tomahawk MC Tactical Light to determine the range of colors people are able to see~     with these flashlights at night. The flashlight has been designed to reduce visibility of the~     user and uses a combination of green and red LED lamps to achieve this. In this study~     investigators wish to determine how well a subject can differentiate colors at night in a~     quantifiable manner. Investigators will use the Farnsworth Munsell 100 hue test which~     requires the user to put shades of red, green, blue and yellow into progressive color order~     which is scored according to the manufactures specifications.~   "
125289|NCT01927523|"~     The purpose of this study is to learn more about the most cost-effective way to improve the~     long-term life outcomes of disadvantaged youth, by comparing best practice academic supports~     to best-practice non-academic supports, and learning more about whether investing in both~     simultaneously has synergistic (more than additive) effects.~   "
125290|NCT01927510|"~     Patients in the intensive care unit (ICU) traditionally receive bed rest as part of their~     care. They develop muscle weaknesses even after only a few days of mechanical ventilation~     that may prolong their time in ICU and in hospital, delay functional recovery and delay their~     return home and to work. Weakness may be avoided with simple strategies of early exercise in~     ICU. This pilot study aims to test the hypothesis that early mobilisation may improve~     functional recovery in this patient group and gather pilot data to support a larger~     randomised trial across Australia and New Zealand.~   "
125291|NCT01927497|"~     Rationale: Approximately 800 abdominoperineal resections (APR) are performed for rectal~     cancer each year in the Netherlands. The extralevator approach (eAPR) reduces the rate of~     positive margins and improves oncological outcome in distal rectal cancer. However, wider~     excisions increase wound healing problems and development of perineal hernia. This has~     resulted in a progressive increase of the use of musculocutaneous flaps and biological meshes~     associated with a substantial increase of costs, which is not supported by proper data.~      Objective: The aim of this study is to determine the cost-effectiveness of pelvic floor~     reconstruction using a biological mesh after standardized eAPR with neo-adjuvant~     (chemo)radiotherapy.~      Study design: This is a multicenter study in which patients undergoing an eAPR are randomized~     between standard care using primary closure of the perineum and the experimental arm with~     assisted closure using a biological mesh.~      Study population: Patients with a clinical diagnosis of primary rectal cancer who are~     scheduled for eAPR after neo-adjuvant (chemo)radiotherapy. A total number of 104 patients~     will be randomized.~      Intervention: The intervention in the experimental arm consists of suturing a biological mesh~     derived from porcine dermis in the pelvic floor defect, followed by perineal closure similar~     to the control arm.~      Main study parameters/endpoints: The primary endpoint is the percentage of uncomplicated~     perineal wound healing (Souphampton wound score less than II at day 30). Secondary endpoints~     are hospital stay, incidence of perineal hernia, quality of life, and costs.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: Both primary perineal closure and biological mesh assisted closure are being~     performed in daily clinical practise. The potential benefit resulting from participation of~     the study in patients randomized for biological mesh assisted closure may be a higher chance~     of uncomplicated perineal wound healing and lower perineal hernia rate. On the other hand,~     the use of a biological mesh has been associated with increased postoperative pain and seroma~     formation.~   "
125292|NCT01927484|"~     Osteoarthritis (OA) is a common disabling condition, for which no effective therapy currently~     exists. Synovitis is commonly demonstrated in knee OA imaging. Synovial inflammation due to~     the release of cytokines is an important cause of pain. Methotrexate (MTX) helps to decrease~     synovitis in many inflammatory joint diseases, particularly rheumatoid arthritis.~      The aim of the present study is to assess the efficacy of MTX in decreasing pain and~     inflammation in symptomatic knee OA.~      Methods: One hundred and forty-four patients with American College of Rheumatology (ACR)~     clinical and radiographic criteria of primary knee OA with knee pain, [>4 on the 24-hour~     average pain severity scale (0-10) using mean of daily ratings from week preceding~     randomization] for > 14 days/month during 3 consecutive months preceding enrollment will be~     included in this randomized double-blind placebo-controlled trial. Patients meeting the~     eligibility criteria were randomized in a 1:1 ratio to receive either 25mg/week oral MTX~     (n=72) or placebo (n=72) together with their usual therapy provided the dosages were kept~     constant for 28 weeks. Pain will be assessed using the Visual Analogue pain Scale, (VAS,~     0-100 mm). Functional assessment will be performed using the Western Ontario and McMaster~     Universities Osteoarthritis Index (WOMAC) and Activities of daily living (ADL) scores.~     Alterations in dosage of analgesic/NSAID drugs used will be recorded. Safety and tolerability~     will also be assessed. Synovitis will be detected by ultrasound imaging.~   "
125293|NCT01927471|"~     The investigators would like to determine how aspects of metabolism and age influence ovarian~     function. The purpose of the study is to understand how nutrition and metabolism relate to~     follicle development in women with regular cycles, irregular cycles, or polycystic ovary~     syndrome (PCOS). We also plan to identify lifestyle factors associated with PCOS and~     understand how diet and activity levels impact features of PCOS.~   "
125294|NCT01927458|"~     The purpose of this study is to determine if transcranial direct current stimulation~     (tDCS)applied over the lower extremity motor cortex in conjunction with treadmill training is~     effective for improving gait in patients with subacute stroke and to evaluate the effect and~     predictive value of a single session of anodal tDCS.~   "
125295|NCT01927445|"~     The objective of this project is to increase the proportion of patients with AF that receive~     adequate stroke prevention therapy. Over half of patients with AF who suffer strokes are~     permanently disabled. Yet there remains a large portion of patients who do not receive~     appropriate stroke prevention therapy. The investigators hypothesize that a toolkit of~     quality improvement strategies in primary care could increase the proportion of patients with~     atrial fibrillation appropriately treated with stroke prevention therapy. The investigators'~     goal is to ensure the toolkit of interventions can be easily incorporated into day-to-day~     practice in primary care and can be readily and broadly disseminated if successful.~   "
125296|NCT01927432|"~     In women with regular menstrual cycles, antral follicles have been shown to grow in~     synchronous cohorts, called waves, 2-3 times in a menstrual cycle. It is unknown whether~     these waves of follicle growth also occur in women with amenorrhea or if there is~     abnormal/absent follicle growth. Further, oligo- or amenorrhea has been associated with~     metabolic disturbances, such as over- or under-nutrition, central obesity and insulin~     resistance. Yet, mechanisms whereby metabolic factors influence folliculogenesis in women are~     poorly understood. To understand potential mechanisms, the investigators plan to characterize~     follicle growth dynamics in women with or without regular menstrual cycles and identifying~     key metabolic differences in these women which may be important in normal follicle~     development and fertility.~   "
125297|NCT01927419|"~     The primary purpose of this study is to compare the objective response rate, as determined by~     investigators, of Nivolumab combined with Ipilimumab versus Ipilimumab monotherapy in~     patients with untreated, unresectable, or metastatic melanoma~   "
125298|NCT01927406|"~     The purpose of this study is to evaluate the potential secondary beneficial effect of~     prostaglandin analogues (PA) treatment in thyroid eye disease (TED) patients. This study aims~     to determine if PA would change the course of the orbitopathy in TED patients by altering the~     progression of the common features of TED, including fatty hypertrophy, proptosis, eyelid~     retraction and optic nerve compression. The eyes with thyroid eye disease and elevated~     intraocular pressure will be randomised to the PA treatment and the other eye will serve as a~     control eye and will be treated with Timolol.~   "
125299|NCT01927393|"~     This randomized clinical trial studies palliative care in improving quality of life and~     symptoms in patients with stage III-IV pancreatic or ovarian cancer. Palliative therapy may~     help patients with advanced pancreatic or ovarian cancer live more comfortably.~   "
125300|NCT01927380|"~     The purpose of this study is to measure the variations of autonomic nervous system (ANS)~     modulation directed to the heart and vessels induced by pneumoperitoneum and steep~     trendelenburg position.~   "
125301|NCT01927367|"~     Research Question: Among community-based patients with AF, does providing an integrated~     Clinical Decision Support System (CDSS) to providers and patients improve process of care and~     clinical outcomes, and decrease the healthcare costs and resource utilization over 12 months,~     as compared to usual care?~      Intervention: A web-based clinical decision support system, computerizing the Canadian AF~     clinical guidelines, to support primary care providers and patients in optimizing and~     standardizing AF care.~   "
125305|NCT01927315|"~     Long-standing diabetes is often complicated by retinopathy. The mechanisms that induce the~     development of diabetic retinopathy are incompletely understood and include alterations in~     bone marrow derived vasculogenic cells called endothelial progenitor cells.~      Fenofibrate is a PPAR-alpha agonist used for the treatment of mixed dislipidemia and~     hypertriglyceridemia. In a trial conducted in type 2 diabetic patients, the drug fenofibrate~     has reduced retinopathy-related endpoints suggesting a direct effect of the drug on the~     mechanisms that drive the development of this complication.~      Herein, the investigators hypothesize that fenofibrate treatment can increase circulating EPC~     levels in diabetic patients with retinopathy, compared to placebo.~   "
125306|NCT01927302|"~     The purpose of this study is to investigate the effects of treatment for specific language~     deficits in people with aphasia. In addition to language and cognitive measures, changes in~     brain function will also be gathered before and after the treatment is administered in order~     to track any changes resulting from receiving treatment.~   "
125307|NCT01927289|"~     This is a double-blind prospective randomized control trial. The primary hypothesis is that~     the preservation of motor function is superior in distal forearm blocks compared to~     supraclavicular block. The secondary outcomes include patient satisfaction, surgeon's~     satisfaction, rate of block success, onset and duration of block.~   "
125308|NCT01927276|"~     Out of 300 million persons in the United States, about one-half of one percent, or 1.5~     million, have a diagnosis of schizophrenia. Schizophrenia begins in young adulthood, and~     often is chronic and disabling for the remainder of the life course], which is shorter than~     for the general population by as much as 25 years. The costs of schizophrenia in the United~     States are estimated to be between $30 and $60 billion dollars annually. Treatment for~     schizophrenia is only marginally successful: in the Clinical Antipsychotic Trials of~     Intervention Effectiveness (CATIE), for example, the medication prescribed at the beginning~     of the trial was stopped or changed in nearly 75% by the completion of the trial 18 months~     later. The medications have limited effect on negative symptoms or cognitive impairments of~     schizophrenia, and many have severe and permanent side effects. The basic hypothesis~     underlying treatment for schizophrenia has not changed for more than half a century. New~     treatments are needed.~      Much accumulating evidence suggests that sensitivity to gluten may be related to symptoms or~     etiology in schizophrenia and that gluten free diets may lead to significant symptom~     resolution, but only in patients who are known to have antibodies to gluten.~      Gluten sensitivity may be more common than thought and stems from a different etiology and~     symptom presentation than Celiac Disease. The investigators analysis of the CATIE sample show~     that about 23% of persons with schizophrenia (compared to 3% of healthy controls) have Gluten~     Sensitivity (about 300,000 persons in the United States) through the identification of~     gliadin positive antibodies in their blood. The investigators hypothesize that people with~     this biomarker could have robust symptom improvements with the removal of the antigen from~     the diet (gluten). If only half of people with schizophrenia and these antibodies were to~     substantially benefit from removal of gluten from the diet, as in the case studies and with~     certain subjects in the clinical trials, this would provide a new transformative treatment~     option for an identifiable subpopulation of people with schizophrenia and would be of~     enormous benefit to patients, families and society. Another benefit to the public's health~     from this study will be enhanced knowledge of the etiology of schizophrenia, including~     possible linkages between neuropsychiatric disease and immune system activation, and~     identification of novel, immune-linked treatment targets.~      The results of this research could lead to screening for Anti-Gliadin Antibodies early in~     life or at the first episode of schizophrenia, as recommended by some already. Screening~     involves financial and emotional costs, and better evidence is needed before this~     recommendation can be justified. Moreover, a new treatment paradigm of removing gluten from~     the diet by means of gluten blocking medications (already in early study) could advance~     treatment significantly.~      This study will test the efficacy, in a pilot fashion, of 20 participants in a double blind~     five week randomized placebo controlled gluten free diet vs identical diet with gluten in~     gliadin-positive individuals with schizophrenia. Approximately equal numbers will receive the~     addition of gluten, or non-gluten starch, in identical form (given as flour in food). The~     investigators plan to develop mechanisms and procedures to locate, screen, and recruit~     subjects into the inpatient intervention study, retain them during the inpatient phase. Once~     admitted baseline assessments may take approximately a few days but will be mostly completed~     in the first week prior to the 5 week randomization, thus patients may stay longer than 5~     weeks. At the end of the double blind trial the investigators will prepare for discharge and~     then test the feasibility of successfully maintaining gluten free diets after the~     intervention phase is complete, for at least two months.~   "
125309|NCT01927263|"~     The purpose of this study is to investigate similarity between NI-071 and infliximab(the~     comparator) in terms of efficacy in patients with Rheumatoid Arthritis not adequately~     responding to Methotrexate.~   "
125310|NCT01927250|"~     The purpose of this study is to determine whether multi-dimensional wellness program (diet,~     art and biofield therapy) influences the quality of life for those with different health~     status in Japan.~   "
125311|NCT01927237|"~     The purpose of this protocol is to perform serial physiological measurements and blood~     testing on mechanically ventilated patients comparing conditions of eucapnia and hypercapnia~     in the same patient. We will be testing two hypotheses: (1) while administering inspired~     carbon dioxide (CO2), eucapnia achieved by high respiratory rate (EHR) significantly~     decreases pulmonary artery pressures compared to hypercapnia with a lower respiratory rate~     (HLR), and (2) that EHR decreases myocardial strain compared to HLR.~   "
125312|NCT01927224|"~     This study will evaluate the bioequivalence as well as safety and tolerability of a novel 30~     mg tablet of nifurtimox compared to the corresponding marketed 120 mg tablet in adult~     subjects suffering from chronic Chagas' disease when administered after a high-fat /~     high-calorie test meal. This study is a necessary step for the development of an age~     appropriate pediatric oral dosage form for the treatment of Chagas' disease in endemic~     countries according to the recommendations provided by current international guidelines (EMA~     Guideline on Clinical Development of Medicinal Products, EMA Note for Guidance on Oral Dosage~     Forms).~   "
125313|NCT01927211|"~     The study will investigate whether the placement of silver plated dressings beginning in the~     OR will improve wound healing in patients undergoing cesarean delivery compared to~     traditional Telfa pads. This study will also explore the presumed improvement in scar~     integrity when silver plated dressings are used compared to Telfa pads. The study will~     examine post-operative pain by review of anesthesia and analgesic use during hospitalization~     and scar-related pain scores at the post-operative visits.~      The study will compare the percentage of patients who develop a surgical site infection after~     application of silver plated dressings versus standard Telfa dressings. Investigators will~     also assess the cosmetic appearance of the cesarean section scar at the patient's one week~     and 6 wekk post-operative visits.~   "
125314|NCT01927198|"~     This study will assess the serum uric acid lowering effects and safety of 3 dose levels of~     RDEA3170 compared to placebo in subjects with gout.~   "
125315|NCT01927185|"~     Central venous catheterization is commonly applied in patients undergoing cardiac surgery.~     The subclavian vein has lower risk of infection and provides more patients comfort. However~     central venous catheterization may results in complications such as pneumothorax, hemothorax~     or arterial puncture. It has been suggested that ultrasound (US) guidance could improve the~     success rate, reduce the number of needle passes and decrease complications. Two different~     real-time 2-dimensional US techniques can be employed in the insertion of central venous~     catheters. The first technique involves real-time US-guided cannulation of subclavian vein~     using a long axis/in-plane approach. The second one involves real-time US-guided using a~     short axis/out-off-plane approach. However to date no studies have compared their efficacy~     and safety. The purpose of this study was to compare the US-guided long-axis versus~     short-axis approach for the SCV catheterization in adult critical care patients.~   "
125316|NCT01927172|"~     The purpose of this study is to determine if the AirSonea device provides an objective~     assessment of breath sounds for the presence of wheeze in both medical and home environments.~   "
125317|NCT01927159|"~     The purpose of this study is to determine the safety, tolerability, and immunogenicity in~     BCG-vaccinated healthy adult subjects of an investigational vaccine being developed for the~     prevention of pulmonary tuberculosis.~   "
125318|NCT01927146|"~     By literature review, there is a clear trend towards a potential role for human epidermal~     growth factor receptor 2 (HER2) as a negative prognostic factor in gastric cancer was shown,~     but only in half of the analyses used multivariate statistics. Besides, For the studies in~     the current review that have looked at the Lauren classification in relation to HER2, a~     higher level of overexpression or amplification was found in the intestinal phenotype~     compared to the diffuse or mixed types. As lauren classification was reported as an~     independent prognostic factor result in favored outcomes in gastric cancer (GC), there may~     probably be histologic bias exists when compare overall survival (OS) between HER2 statuses~     without controlling this confounding. Similarly, patients with different disease settings~     (early stage and advanced stage; resectable and metastatic) affect outcomes either.~      In this study, the investigators will retrospectively analyze HER2 status and lauren~     classification in 800 gastric patients who received gastrectomy in the Cancer Center of Sun~     Yat-Sen University between January 1996 and December 2006 with formalin-fixed and paraffin-~     embedded tumor tissue samples. To avoid potential influence by histologic classifications and~     disease settings, the investigators assess difference in OS between HER2 positive and HER2~     negative groups in resectable Lauren classification of GCs, and further evaluate the~     prognostic value of HER2 status according to tumor-node-metastasis (TNM) stages.~   "
125321|NCT01927107|"~     The global obesity epidemic presents an unprecedented challenge to the public health~     worldwide. The factors associated with obesity are complex, and include health behaviors,~     such as eating habits and daily physical activity, and broader social, environmental and~     biological determinants that influence these health behaviors. The intestinal microbiota has~     several beneficial functions related to host health and accumulating evidence indicates that~     the gut microbiota plays a significant role in the development of obesity, obesity-associated~     inflammation and insulin resistance. Experimental studies reveal a shift in the abundance of~     Bacteroidetes and Firmicutes. Presumably, obesity affects the diversity of the gut microbiota~     and, probably, the way individuals harvest energy from nutrients. Differences in community~     composition, functional genes and metabolic activities of the gut microbiota appear to~     distinguish lean vs obese individuals, suggesting that gut 'dysbiosis' contributes to the~     development of obesity and/or its complications.~      Recent studies have suggested some beneficial effects of probiotics and/or prebiotics on~     obesity and metabolic syndrome in adults; such experience is limited in children and~     adolescents. The aim of this study was to evaluate potential effects of add-on probiotics to~     standard therapy on anthropometric measurements, lipid profile and oxidative stress~     parameters in children.~   "
125322|NCT01927094|"~     -  Acute diarrhea continues to be a major cause of childhood morbidity and mortality in~          developed and developing countries.~        -  Prevention and treatment of dehydration are the mainstays of therapy. Rehydration can be~          achieved with oral rehydratation solution (ORS).~        -  Even though ORS has reduced the mortality and morbidity very significantly, it has no~          effect on the duration of diarrhea, stool consistency and frequency and remains~          underused.~        -  ESPGHAN and ESPID published together an evidence based guideline and stated that in the~          management of acute gastroenteritis rehydration is the key treatment and that selected~          probiotics may reduce the duration and intensity of symptoms and can be used as an~          adjuvant to ORS.~        -  Current evidence also indicates that probiotic effects are strain-specific.~          Lactobacillus GG and Saccharomyces boulardii are the best studied strains. However, more~          research is needed to guide the use of particular probiotic regimens and strains and as~          there is still no evidence of efficacy for many preparations.~   "
125323|NCT01927081|"~     The purpose of this research study is to evaluate whether self-management discussion groups~     are helpful for women with advanced breast cancer who are experiencing pain. The study is~     looking at the usefulness of two different types of discussion groups, one of which also~     includes gentle exercise.~   "
125324|NCT01927068|"~     Cohort 1: Single-Arm, multicenter study to continue to assess the safety and performance of~     the Cardiovascular Ingenuity (CVI) Paclitaxel-Coated PTA Balloon Catheter in the treatment of~     de novo or restenotic lesions in the superficial femoral and/or popliteal arteries Cohort 2:~     To evaluate this patient population for treatment of in-stent restenotic lesions~   "
125325|NCT01927055|"~     Evaluate the clinical efficacy and safety of droxidopa versus placebo over a 17 week~     (maximum) treatment period in patients with symptomatic NOH.~   "
125326|NCT01927042|"~     Family therapy is considered an empirically supported treatment approach for adolescents and~     adults with eating disorders. One family based approach, Expert Carers Helping Others (ECHO)~     is based on evidence that suggests family environment, e.g., carer criticism, can influence~     an individual's eating disorder symptoms. ECHO aims to improve carer coping, reduce expressed~     emotion and manage eating disorder symptoms, and has been associated with reduced carer~     distress, caregiver burden, and an increase in general well being. The current pilot study~     seeks to evaluate a new condensed version of the ECHO intervention that is delivered entirely~     in a 2 ½ hour self-help DVD format (ECHOs). Sixty patients and their carers will be recruited~     from the Capital Health Eating Disorders Service and randomized into either a treatment as~     usual group (TAU) or a TAU+ECHOs group. Both carers and patients will be assessed along a~     variety of dimensions including psychiatric symptoms, family functioning, and carer and~     patient collaboration, at pre-intervention, four weeks later at post-intervention, and then~     three-months post-intervention. ANOVAs will be used to compare the primary outcomes between~     the two groups over time. This pilot study will be the first evaluation of ECHOs, which may~     ultimately boost the efficacy of current treatment for adults with eating disorders and~     reduce carer distress.~   "
125327|NCT01927029|"~     Twin pregnancies have very high preterm delivery rate. Until now, no RCT has proven benefit~     of progesterone in this population. In contrast, singleton pregnancies are treated with this~     hormone. The objective is to compare 180mg/day progeterone vaginal gel with 180mg/day with~     placebo, from 18 weeks to 34 weeks. The sample size was calculated and 213 cases in each~     group are needed to demonstrate a reduction of preterm delivery <34weeks from 13% to 7%.~   "
125328|NCT01927016|"~     Background~        -  Esophageal carcinoma is the sixth leading cause of cancer -related mortality and the~          eighth most common cancer worldwide~        -  The incidence is increasing rapidly~        -  The overall 5-year survival ranges from 15% to 25% in the literature and poor outcomes~          are related to diagnosis at advanced stages.~        -  Surgery used to be the cornerstone of treatment of resectable esophageal cancer, but~          treatment of esophageal carcinoma remains challenging and need to be considered through~          a multimodal approach. However the modalities and the impact of this multimodal approach~          at a national level are unknown Primary objective: To identify predictors of recurrence~          after esophageal cancer surgery~      Secondary objectives :~        -  5-year recurrence free survival~        -  5-year overall survival~        -  Predictors of postoperative mortality and morbidity after surgery~        -  Impact of pCR on recurrence and survival~        -  Impact of neoadjuvant treatments on recurrence and survival~        -  Impact of patient preconditioning (such as nutritional support, esophageal prosthesis,~          mini-invasive approach…) on outcomes~      Methodology : European French-speaking retrospective multicentric study Inclusion criteria:~     All consecutive patients operated on, for a histologically proven carcinoma of the esophagus,~     the oesophago-gastric junction (Siewert type I and II), in surgical investigator centers~     between January 2000 and December 2010 Exclusion criteria: Siewert III type carcinoma of the~     oesophago-gastric junction , non surgical treatment of esophageal carcinoma Planned study~     period: The data will be collected over a 11-year period from January 2000 to December 2010.~     Follow up will be ascertained in May 2013.~   "
125332|NCT01926964|"~     Oncotype DX® is likely to become more widely used in Europe as well as in Switzerland. The~     test is currently not reimbursed by the Swiss health insurances.~      The proposed study will investigate to what extent adjuvant treatment recommendations in~     breast cancer patients with an ER-positive tumor, made by Swiss tumor boards, are based on~     conventional factors, and whether the recommendations would change, when RS results from the~     Oncotype DX® test were available.~      In addition this study approaches the dilemma of adding adjuvant CT to adjuvant endocrine~     therapy in a systematic fashion. In this study, the St. Gallen consensus 2009 (with a minor~     update from the 2011 consensus, is used to predefine the patients suitable for endocrine~     therapy or chemo-endocrine therapy. Once results of this study are available they may help to~     better integrate Oncotype DX® with other factors. Currently, it is unclear how the different~     factors should be integrated into one recommendation.~      This study will provide data on the usefulness of this test for the two patient groups which~     are suitable for hormone therapy only and for those who are considered for hormone plus~     chemotherapy.~   "
125333|NCT01926951|"~     This study will evaluate the effects of renal denervation using externally focused~     therapeutic ultrasound with external targeting and tracking on patients with refractory~     hypertension.~   "
125334|NCT01926938|"~     Diabetes is a major public health problem. Hispanics/Latinos are known to be at higher risk~     for type 2 diabetes. The function of the endothelium has played a key role in the~     understanding of vascular complications in people with diabetes. Endothelial function and~     vascular reactivity are impaired not only in white adults with type 2 diabetes but also in~     those at risk for the disease by virtue of having impaired glucose tolerance or parental~     history of type 2 diabetes. Whether this finding is applicable to hispanics is not known. The~     investigators plan to assess the endothelial function and vascular reactivity in young~     Hispanic adults at risk of developing type 2 diabetes by virtue of being obese and belonging~     to a minority population.~   "
125335|NCT01926925|"~     Type 2 diabetes is now more frequent in children/adolescents, especially in those from~     minority populations, including Hispanic Americans (HA). Diabetes and the pre-diabetes state~     markedly increase the risk of cardiovascular disease. Endothelial dysfunction is seen in the~     earliest stages of atherogenesis, which ultimately leads to cardiovascular disease. The main~     aim of this study is to evaluate the endothelial function in HA children/adolescents who are~     at risk for developing type 2 diabetes (obese children/adolescents from the Hispanic~     population).~      The investigators' hypothesis is that endothelial dysfunction is present in this population~     and that it is associated with metabolic abnormalities linked to the insulin resistance~     syndrome. The investigators will study 2 groups of 15 individuals each, age 10-18 years.~     Group 1 will consist of obese (body mass index greater than 85th percentile for age and sex)~     Hispanic American children/adolescents and group 2 will consist of healthy, non-overweight~     (body mass index between the 25th and 50 th percentile for age and sex) Hispanic American~     children/adolescents.~      The study will be carried out at the Joslin Diabetes Center. During the first day,~     participants will have a medical history and full physical examination, a standard OGTT and~     measurement of blood cell count, plasma glucose, insulin, lipids, HbA1c, BUN, creatinine,~     electrolytes, estradiol, testosterone, free fatty acids, CRP, endothelial markers, urinary~     microalbumin and hCG, if appropriate. An OGTT will be performed in order to rule out IGT or~     Diabetes. Estimations of insulin secretion and insulin sensitivity will be assessed using the~     homeostasis model assessment (HOMA). In the second day, the body composition and the brachial~     artery vasodilatory response to hyperemia will be assessed. Those found with diabetes will be~     tested for GAD-65 and IA2.~      The investigators' hypothesis is that Hispanic American children/adolescents at risk for type~     2 diabetes have impaired endothelial function and vascular reactivity that are associated~     with the degree of insulin resistance and its metabolic abnormalities.~   "
125336|NCT01926912|"~     The purpose of this study to evaluate safety, tolerability, treatment outcomes, appropriate~     use and pattern of paliperidone palmitate usage in participants with schizophrenia in the~     hospital setting.~   "
125337|NCT01926899|"~     The objective of this study is to determine the maximum tolerated dose (MTD) of bortezomib in~     combination with calcineurin inhibitor and methotrexate as acute graft versus host disease~     (aGVHD) prophylaxis in pediatric patients undergoing allogeniec hematopoietic stem cell~     transplant (alloHSCT)~   "
125338|NCT01926886|"~     This single arm, multicenter study will evaluate the safety of assisted subcutaneous~     administration of Herceptin (trastuzumab) in patients with HER2-positive early breast cancer.~     Patients who have completed the first 6 cycles of intravenous Herceptin as part of the~     (neo)adjuvant treatment will be eligible to receive a further 12 cycles of Herceptin in this~     study. For the first 3 cycles, Herceptin will be administered intravenously (6 mg/kg) at the~     hospital. The next 3 cycles, Herceptin (600 mg every 3 weeks) will be administered~     subcutaneously via a hand-held syringe by a trained HCP at the hospital, and for the last 6~     cycles Herceptin will be administered subcutaneously via a hand-held syringe by a trained HCP~     at the patient's home.~   "
125339|NCT01926873|"~     This multi-center screening study will conduct a cognition assessment to collect reference~     data for comparison to patients with depression in healthy volunteers. Data will be collected~     for 6 weeks.~   "
125340|NCT01926860|"~     The present study explores whether a simultaneously given hepatitis A vaccine (Epaxal) will~     have an impact on the immune response to PCV13 (pneumococcal conjugate vaccine; Prevenar13)~     vaccine in adults. The immune response to PCV13 is measured as levels of serotype specific~     serum antibodies and their opsonophagocytic activity. The results of volunteers receiving~     PCV13 and Epaxal will be compared to that in a control groups of adults receiving either~     hepatitis A or PCV13 vaccines only.~   "
125341|NCT01926847|"~     Patients with Raynaud's phenomenon suffer from painful attacks triggered by stress or cold~     causing acute lowering of blood flow through the digits. In this trial the safety and~     efficacy as well as the effect of one dose of the sGC stimulator Riociguat on digital blood~     flow will be measured during a cold exposure test in patients suffering from Raynaud's~     phenomenon. Measurements of two periods will be compared: in one period the patient will be~     given active drug and in the other period a placebo.~   "
125342|NCT01926834|"~     To study the effects of Erigeron Injection on human serum VEGF, MMP-9 and EPC levels after~     acute cerebral infarction,test is made by random double-blind controlled.patients with acute~     cerebral infarction were divided randomly into erigeron injection+aspirin group,aspirin~     group,and health people. The main indexes are the serum level of VEGF, MMP-9 and EPC.The~     review is made by the reference to NIHSS and so on. So, Erigeron Injection have the function~     of promoting angiogenesis in multiple targets through this test.~   "
125343|NCT01926821|"~     The impact of sonifilan on the quality of life in patients with cervical cancer during~     radiation or chemoradiation therapy~        1. Primary endpoint : Quality of life~        2. Secondary endpoint : complications related to Sonifilan, treatment effect of Sonifilan~   "
145513|NCT01662518|"~     This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone~     (DDS-25) for the treatment of macular edema associated with retinal vein occlusion.~   "
125345|NCT01926795|"~     Toddler's fractures of the tibia are by definition non-displaced and of a stable pattern.~     Children have thickened periosteum compared with adults, which therefore may impart stability~     to the fracture without the need for additional immobilization. The goal of the study is to~     evaluate whether or not there is a difference in children treated with and without cast~     immobilization in regards to time to ambulation; perceived pain; difficulty in dressing &~     bathing; radiographic displacement or angulation; and time missed from work or daycare. Our~     null hypothesis is that there will be no difference in clinical or radiographic outcomes~     between the groups.~   "
125346|NCT01926782|"~     To determine the efficacy, long-term safety, and tolerability of alirocumab 300 mg every 4~     weeks (Q4W), in comparison with placebo, as well as its potential as a starting regimen. The~     dose regimen of 75 mg every 2 weeks (Q2W), as used in other studies, was added as a~     calibrator.~   "
125347|NCT01926769|"~     To determine the safety and efficacy of second-line treatment with Metformin and Chemotherapy~     (FOLFOX6 or FOFIRI) in the second line treatment of advanced colorectal cancer~   "
125348|NCT01926756|"~     This is a prospective randomized controlled trial to look into the reduction of catheter~     associated urinary tract infections in the postoperative period. It will specifically look at~     short gynecologic procedures such as D&C (dilation and curettage), hysteroscopies and LEEP~     procedures and the need to perform intraoperative catheterization. If a patient urinates~     immediately before a short operation then there is no need to drain the bladder with a~     catheter during the procedure. The investigators hypothesize that eliminating catheterization~     during these short procedures may decrease postoperative urinary tract infections. The hope~     is that this study would provide evidence to support a change in practice.~   "
125349|NCT01926743|"~     Lymph node dissection in gastric cancer surgery is a very important factor not only for exact~     acquisition of stage but also proper treatment. Realistically, it is impossible to identify~     complete removal of lymph node in dissected nodal station by naked eye. The investigators can~     assess the route of lymphatic drainage and identify residual lymph nodes in dissected area.~     In the field of gastric cancer treatment, ICG and near infra-red fluorescence imaging was~     used only detection of sentinel lymph nodes. However, this novel concept can help to~     understand lymphatic drainage and make surgeons to perform D1+ or D2 lymph node dissection~     completely.~   "
125350|NCT01926730|"~     The proposed study is a randomized controlled trial of a limited restriction diet compared to~     a regular diet among patients with Crohn's disease (CD) in remission. At baseline, patients~     will complete a semi-quantitative food frequency questionnaire assessing usual dietary~     patterns over the preceding month. Disease activity will be assessed with the abbreviated~     Crohn's Disease Activity Index (aCDAI)59. Self-reported disease status will be assessed~     during follow-up using an internet-based questionnaire. Repeat assessment of adherence to the~     study diets will be assessed with food frequency questionnaires (FFQs) administered after 20~     weeks. Follow-up duration will be for 48 weeks. Statistical analysis will compare the time to~     relapse using Cox regression for patients in the two study arms. In the exploratory aim, we~     will compare outcomes among patients in the highest tertile for other food items and~     nutrients to those in the lowest tertile based on self-reported usual dietary patterns at~     baseline. Thus, the study population will be analyzed both as a randomized controlled trial~     and as a prospective cohort study.~   "
125351|NCT01926717|"~     This study is being done to learn more about how different surgery procedures bring back the~     quality of life.After removing the small intestine at least 20cm in patients with pancreatic~     cancer, Some patients develop problems because they are disorder their digestive system, such~     as cramping, heartburn,vomiting.~   "
125352|NCT01926704|"~     Human visual acuity and contrast sensitivity are highly dependent on various different~     parameters. Each should be optimized for perfect visual performance. However, in real life~     our eyes lack such parameters, which might lead to unsatisfying results even after spectacle~     correction or contact lenses.~      A promising approach would be to design intra ocular lenses (IOL), which are implanted into~     the eye for example in the course of cataract extraction and are able to compensate for the~     human eyes' aberrations.~      For example cutoff frequency, edge-sharpness or specific contrast for selected structure~     sizes would need to be considered. Since, an aberration free optical system is almost~     impossible and since the impact of each single parameter is not yet known, IOL design~     parameters would have to be chosen very carefully.~      Furthermore, image quality of IOLs still is tested ex vivo by ray tracing for example, but~     this does not guarantee perfect function after implantation, as our visual system has complex~     image precessing units form the retina to the brain.~      The present study picks one of these parameters and seeks to assess its impact on visual~     quality in-vivo. By subjectively grading different images with objective changes to image~     quality by variations of the modulation transfer function (MTF), the potential influence and~     thus on our subjective visual impression shall be assessed.~   "
125353|NCT01926691|"~     Background: Recent studies have demonstrated that even mild stroke survivors experience~     residual damage, which persists and in fact increases in subsequent years. About 45% of~     stroke victims remain with different levels of disability. While studies on cognitive~     impairment and dementia after stroke are receiving increasing clinical attention, the~     underlying pathophysiology is poorly understood. Identifying the mechanisms involved and~     recognizing early biomarkers for individual vulnerability, require a multi-modal approach, as~     the mechanisms involved in cerebrovascular disease and individual trajectories of post-stroke~     recovery may impact upon each other on various levels.~      Aims and Hypothesis: To date there is no single measure that can be used to identify patients~     who are prone to develop cognitive impairment and other disabilities from those with better~     recovery prospects.~      We hypothesize that data based on biochemical, neuroimaging, genetic and psychological~     measures can, in aggregate, serve as better predictors for subsequent disability, cognitive~     and neurological deterioration, and suggest possible interventions.~      Design: The TABASCO (Tel-Aviv Brain Acute Stroke Cohort) study is an ongoing, prospective~     cohort study aim to recruit about approximately 1125 consecutive first-ever mild-moderate~     stroke patients. It is designed to evaluate the association between predefined demographic,~     psychological, inflammatory, biochemical, neuro-imaging and genetic markers, measured during~     the acute phase, and long-term outcome: subsequent cognitive deterioration, vascular events~     (including recurrent strokes), falls, affective changes, functional everyday difficulties and~     mortality.~      Discussion: This study is an attempt to comprehensively investigate the long term outcome of~     mild-moderate strokes. Its prospective design will provide quantitative data on stroke~     recurrence, the incidence of other vascular events and the evaluation of cognitive, affective~     and functional decline. Identifying the factors associated with post stroke cognitive and~     functional decline could potentially yield more effective therapeutic approaches.~      We believe that an extensive approach of analyzing the interaction between different risk~     factors would more accurately predict neurological deterioration.~   "
130541|NCT01858662|"~     To analyze the pathological tumor response on resected colorectal cancer metastases after~     preoperative treatment with cetuximab combined with FOLFOX or FOLFIRI regimen in a~     prospective cohort (RAS and B-RAF WT tumors) and to correlate this response with patient's~     outcome.~   "
125354|NCT01926678|"~     With approximately 12 million cancer survivors today in the United States alone, increased~     attention is being given to quality of life after cancer treatment. Cancer-related fatigue~     (CRF) is one of the most prevalent and debilitating symptoms experienced by people with~     cancer. It can persist for months or years after cancer therapy is completed and has a~     negative impact on all areas of function. Meaningful evidence-based treatment options for CRF~     are extremely limited and finding safe, inexpensive, and effective interventions for managing~     this distressing symptom are urgently needed. Basic research has shown that activation of the~     immune system can cause potent changes in behavior including reduced activity, fatigue, and~     decreased social behavior. Furthermore, research over the last decade has found a~     relationship between levels of CRF with increased inflammation. Thus, study of therapies that~     may decrease immune system activation in the setting of CRF represents a possible target for~     intervention. Massage therapy is one of the fastest growing alternative therapies and has a~     high rate of acceptance for symptom management among cancer patients. Massage has been shown~     in smaller studies with cancer patients to modulate the immune system. Moreover, massage has~     been demonstrated to significantly decrease markers of immune system activation in normal~     subjects. There are no published randomized controlled trials examining either the role of~     massage as an intervention primarily for CRF or investigating whether massage related~     decreases in immune system activation are responsible for improvement in CRF. This proposal~     investigates the effects of massage therapy on CRF among breast cancer survivors. The~     investigators' primary hypothesis is that Swedish Massage Therapy (SMT) will decrease CRF~     compared to a light touch condition and wait list control. The investigators' secondary~     hypothesis is that SMT will decrease CRF by reducing immune system activation. The~     investigators' main exploratory hypothesis is that a decrease in CRF will increase quality of~     life among cancer survivors.~   "
125355|NCT01926665|"~     The goal of this clinical research study is to find the highest tolerable dose of carfilzomib~     that can be given to patients with lymphoma after a stem cell transplant. The safety of this~     drug will also be studied.~      Carfilzomib is designed to block cancer cells from repairing themselves. If the cancer cells~     cannot repair themselves, this may cause them to die.~   "
125356|NCT01926652|"~     Clinical trial to evaluate the pharmacokinetic interactions and safety between single dose of~     amlodipine 10mg and candesartan 32mg and the combination dose amlodipine 10mg with~     candesartan 32mg in healthy male volunteers.~   "
125357|NCT01926639|"~     Patients with non-curable disseminated follicular lymphoma receive local radiotherapy~     targeting single lymph nodes and injection of low-dose rituximab (anti-CD20) and autologous~     dendritic cells. The therapy is repeated 3 times, targeting different lesion. Aims are to~     induce tumor immunity and clinical responses.~   "
125358|NCT01926626|"~     The proposed study will assess the efficacy of moclobemide, a selective, reversible MAO-A~     inhibitor, in facilitating smoking cessation in treatment-seeking female smokers. This~     rationale is based on several findings from previous work: 1) cigarette smoke contains~     constituents that inhibit both forms of the enzyme monoamine oxidase (MAO-A and MAO-B); 2)~     that severity of depression symptoms after smoking abstinence is correlated with the level of~     MAO-A inhibition previously obtained from smoking; 3) moclobemide, an MAO-A inhibitor was~     found efficacious in a smoking cessation treatment trial (Berlin et al., 1995); and 4) women~     show a greater association between smoking and depression than men and women smokers in our~     previous trials report smoking to alleviate symptoms of depression to a greater extent than~     men.~   "
125359|NCT01926613|"~     The purpose of this study is help people with serious mental illness and receiving vocational~     rehabilitation get and keep the job they want by improving their thinking skills, such as~     attention and memory, using computer exercises and other strategies. One half of the~     participants in the study will receive vocational rehabilitation and the exercises to improve~     thinking skills, and the other half will receive just vocational rehabilitation. All~     participants will receive an assessment of symptoms and thinking skills at the beginning of~     the study and 6, 12, and 24 months later. Work activity during the 24 months in the study~     will be collected. It is expected that those participants who receive the practice of their~     thinking skills will be more likely to get and keep the job they want compared with people~     who do not receive this treatment.~   "
125360|NCT01926600|"~     Compare 24-hour intragastric pH and therapeutic effectiveness of proton pump inhibitor (PPI)~     among different administration methods: per oral (PO), intravenous (IV), and sublingual (SL).~   "
125361|NCT01926587|"~     This study, is a Phase I/II clinical trial in three parts: Phase I Dose Escalation, Phase II,~     Part 1 RPTD Cohort, and Phase II, Part 2 Expansion. The first two parts have been completed.~     The Phase II, Part 2 Expansion will assess if treatment with rigosertib in combination with~     azacitidine, has measurable effects in patients with myelodysplastic syndrome (MDS). Safety~     of patients is an objective throughout all parts of the study.~   "
125362|NCT01926574|"~     Long-term sick-listing from work has considerable impact on social function, on the families~     of the sick-listed persons, the companies they work for, and society as a whole. Hence, the~     need for documented effective vocational rehabilitation programs is pressing. Vocational~     rehabilitation services described in the scientific literature have been specific to one~     single or a specific group of medical conditions (e.g.low back pain). In contrast, most~     people on sick leave have several health complaints, and many of the factors influencing sick~     leave are shared regardless of disorder (e.g. social surroundings, workplace environment),~     calling for rehabilitation programs that can be employed for both musculoskeletal-,~     unspecific- and common mental disorders. Aim of this study is to investigate whether a group~     based rehabilitation program for musculoskeletal, mental or unspecific complaints can~     facilitate return-to-work (RTW), thereby testing two multicomponent return-to-work RTW~     rehabilitation programs.~   "
125363|NCT01926561|"~     Patients's demographics and perioperative factors affect the occurrence of hypotensive~     bradycardic events in the patients undergoing arthroscopic shoulder surgery in the sitting~     position under interscalene block.~   "
125364|NCT01926548|"~     This study is designed to evaluate the pharmacokinetics of CJ Imatinib mesylate tablet 1 x~     200mg compared with Gleevec film-coated tablet 2 x 100mg in healthy male volunteers.~   "
125376|NCT01926392|"~     Partial thickness burns are a common, painful injury requiring a great deal of resources in~     their care. Silver sulfadizine is a commonly-used topical antimicrobial, but is difficult to~     remove due to its lipid base. We are comparing a water-based topical antimicrobial therapy to~     silver sulfadiazine and hypothesize that the water-based therapy is superior in terms of pain~     control and resources required to deliver care.~   "
125391|NCT01926197|"~     The goal of this study is to determine the safety and efficacy of a chemotherapy regimen~     known as Modified FOLFIRINOX (mFFX) alone or with the addition of Stereotactic Body~     Radiotherapy (SBRT). We hope to learn if this new treatment combination helps to control the~     disease and improve survival for patients with locally advanced pancreatic cancer.~   "
145514|NCT01662505|"~     To investigate safety, tolerability, maximum tolerated dose of volasertib in Japanese~     patients with AML~   "
125365|NCT01926535|"~     The amniotic membrane (AM) is an avascular structure derived from fetus, which is a good~     choice for regenerative medicine and effective treatment in eye surface pathologies such as~     bullous keratopathy (BK). This disease generates a chronic corneal edema evolving to the~     production of vesicles and bullae, chronic eye pain and visual acuity decrease.~      Definitive treatment for those patients is corneal transplant; however, donation is not~     always available and thus requires long waiting times. The currently available palliative~     treatment consists in the use of contact lenses to prevent the corneal epithelium from~     falling. However, this may be associated with corneal neovascularization, lens displacement~     or loss, infections, and discomfort for the patient.~      The objective of this work was to compare the use of amniotic membrane grafts versus contact~     lenses in patients suffering from BK awaiting a corneal transplant.~      A randomized clinical trial assay was performed with patients with a clinical diagnosis of~     BK. Twenty patients were randomized into 2 groups: amniotic membrane and therapeutic contact~     lenses. Eye pain intensity (Analog visual scale), visual acuity (Snellen questioner), bullae~     and corneal epithelial defects presence, as well as corneal neovascularization and~     complications (biomicroscopy) were compared during 6 months.~   "
125366|NCT01926522|"~     The investigators evaluated the effectiveness of the application of analysing treadmill,~     muscle strengthening and balance training compared to a control intervention in patients with~     diabetic neuropathy.~   "
125367|NCT01926509|"~     This study will evaluate the safety, tolerability, and PK of MK-8892 in participants with~     pulmonary arterial hypertension. The primary hypothesis is that the geometric mean of MK-8892~     area under the concentration time-curve from Hour 0 to 24 hours (AUC0-24hr) in participants~     with PAH, will be equal to or greater than the efficacious exposure in humans of 0.6 μM•hr.~   "
125368|NCT01926496|"~     The purpose of the study is to compare the risk of developing squamous skin cancer (SCC) or~     other types of cancer after treatment of AKs with ingenol mebutate gel or imiquimod cream.~     Subjects will be randomised to treatment with ingenol mebutate or imiquimod and will receive~     a second treatment cycle with the same treatment if the first treatment does not clear all~     AKs. Subjects will be followed over a period of three year (36 months) after first treatment~   "
125369|NCT01926483|"~     The investigators hypothesized that the Neoadjuvant Chemoradiotherapy was a beneficial~     treatment for Patients with Stage IIIA-N2 Non-Small Cell Lung Cancer, so we try to evaluate~     the security of treatment, the QoL of patients and the influence to the PFS and OS.~   "
125370|NCT01926470|"~     Lumbosacral transforaminal epidural steroid injection (TFESI) is helpful for the treatment of~     lumbosacral radicular pain, but in case of intravascular injection, infrequently serious~     complication can be developed. Against this backdrop, if there is any difference of frequency~     of intravascular injection incidence during S1 TFESI between method in anteroposterior view~     and method in oblique view using Scotty dog, the result can be crucial factor in selecting~     the approach. In addition, appropriate volume of injection will be checked in each approach.~   "
125371|NCT01926457|"~     The investigators plan to study a sample of women with prediabetes (diagnosed by Hemoglobin~     A1c (HbA1c) 5.7-6.4% or fasting plasma glucose (FPG) 92-125 mg/dL) in the first trimester of~     pregnancy, and patients will be randomized to first trimester or third trimester treatment;~     the first trimester group will receive intervention immediately upon diagnosis of prediabetes~     whereas the third trimester group will receive only routine prenatal care until 28 weeks at~     which time they will receive intervention.~      Intervention is defined as:~        -  diabetes education~        -  blood glucose monitoring~        -  medications as needed~        -  growth ultrasounds~        -  antenatal testing~      The primary outcome is umbilical cord C-Peptide >90th percentile. Secondary outcomes include~     neonatal fat mass at delivery, infant weight-for-length at 12 months of age, maternal~     gestational weight gain, and biomarkers (chemicals) measured in the placenta and the baby's~     umbilical cord blood.~      The investigators hypothesize that women who undergo the above intervention in the first~     trimester will deliver significantly fewer neonates with umbilical cord C-Peptide >90th~     percentile, and that the neonates will have lower fat mass, and weight-for-length at 12~     months. The investigators further hypothesize that a greater proportion of patients~     undergoing first trimester intervention will have appropriate maternal gestational weight~     gain as defined by the Institute of Medicine, and a greater proportion will return to~     prepregnancy weight within 12 months.~   "
125372|NCT01926444|"~     GIC-1001 is a novel, orally-administered, colonic analgesic drug developed as an alternative~     to i.v. sedation during full colonoscopy. It will be evaluated for efficacy and safety in a~     multi-center, randomized, double-blind, placebo controlled, dose-ranging, proof of concept~     Phase 2a trial. Up to 240 patients will receive one of 3 doses of GIC-1001 or its matching~     placebo. A pharmacokinetic evaluation will be carried out on a subset of patients (N: 24).~   "
125373|NCT01926431|"~     The primary aim of this study was to determine the effects of an acute bout of high intensity~     exercise on the brains response to viewing pictures of food using functional magnetic~     resonance imaging (fMRI).~   "
125374|NCT01926418|"~     The purpose of this study is to assess the utility of the Theory of Planned Behavior in~     predicting condom use among men who have sex with men. It also aims to assess the utility of~     two interventions, one known as implementation intentions, the other involves the practice~     of a planning task known as the tower of Hanoi, in increasing condom use in this~     population.~   "
125375|NCT01926405|"~     Hypersomnia is defined as a reduced ability to remain awake during the day. There are~     basically two types of central hypersomnia: narcolepsy and idiopathic hypersomnia. Currently,~     the diagnosis of these sleep disorders is based on polysomnographic recordings which is~     difficult to access. Tests of sleepiness (Epworth, Karolinska) are subjective.~      A biological marker of sleepiness, easily accessible and measurable, would be very useful for~     the diagnosis and therapeutic follow up of excessive diurnal sleepiness. Salivary secretions~     appear as good physiological markers. Studies have shown for healthy subjects, that the~     expression and activity of salivary amylase are increased when subjects are deprived of~     sleep.~      The investigators propose to explore the usefulness of salivary biomarkers (including~     amylase) as a new non-invasive and simple technique for the assessment of excessive daytime~     sleepiness.~   "
125390|NCT01926210|"~     This is a prospective, randomized clinical trial to compare the efficiency and safety of mild~     stimulation and controlled ovarian stimulation protocol on the treatment of POR. The~     randomization is achieved on the basis of a computer-generated randomization list in a 1:1~     ratio.~   "
125377|NCT01926379|"~     The purpose of the ENRICH study is to evaluate a combination intervention package (CIP)~     designed to improve implementation of Isoniazid Preventive Therapy (IPT) among people living~     with HIV (PLWH) in Ethiopia. The study is a two-arm cluster randomized trial, randomized at~     the HIV clinic level, which includes 10 HIV clinics in Dire Dawa and Harari, Ethiopia.~     Clinics are randomized to deliver the combination intervention package (CIP) or standard of~     care (SOC), with stratification by facility size (<80 or >80 patients enrolled in HIV care~     per year). The experimental intervention will be delivered to all patients in HIV clinics~     randomly assigned to CIP who initiated HIV care at the CIP site on or after January 1, 2013~     and initiated IPT on or after date of study initiation, July 1, 2013. In HIV clinics assigned~     to SOC, usual care procedures for provision of IPT will be delivered.~      Study Aims and Hypotheses~      Aim 1. Characterize and compare the effectiveness of a combination intervention package with~     standard of care for IPT provision in Ethiopia.~      Hypothesis 1.1: IPT initiation for new patients enrolling in HIV care at CIP clinics will be~     higher than that for newly enrolled patients at SOC clinics.~      Hypothesis 1.2: Adherence to and completion of IPT for participants initiating IPT at CIP~     clinics will be higher than that for those initiating IPT at SOC clinics.~      Aim 1a. Assess acceptability of CIP among participants enrolled in HIV care and healthcare~     providers at CIP clinics. Acceptability will include: 1) perceived barriers and facilitators~     of uptake and delivery of the intervention package among healthcare providers, and 2)~     acceptability and utilization of intervention components as well as the overall intervention~     package among IPT initiators and non-initiators.~      Aim 2. Assess the impact of CIP compared with SOC on HIV-related outcomes.~      Hypothesis 2: HIV-related outcomes for participants receiving IPT at CIP clinics will be~     superior to outcomes in participants receiving care at SOC clinics. HIV-related outcomes to~     be assessed include retention in care and, among those participants receiving antiretroviral~     therapy (ART), adherence to ART and CD4+ count.~      Aim 3. Assess the safety and tolerability of IPT among HIV-infected individuals under routine~     program conditions in Ethiopia.~      Aim 4. Identify patient and program characteristics associated with IPT adherence and~     completion at SOC sites.~      Hypothesis 4.1: IPT adherence and completion will be associated with modifiable patient~     characteristics, including ART status; knowledge and attitudes about IPT; and social support.~      Hypothesis 4.2: IPT adherence and completion will be associated with modifiable program~     characteristics, including provider/patient ratio, patient tracking, and patient support~     groups.~   "
125378|NCT01926366|"~     This is a randomized, double-blind, placebo-controlled study of single and multiple ascending~     dosage levels of AZD6423 in healthy volunteers. The study includes an up to 28-day screening~     period, an in-house period during which AZD6423 or placebo will be administered IV, and a 4-~     to 10-day follow-up period after discharge.~   "
125379|NCT01926353|"~     Endoscopic correction of VUR has gained its popularity due to its less invasiveness,~     associated low morbidity and short hospital stay. Although short term follow-up had justified~     their efficacy; however, long term recurrence and complications following endoscopic~     correction were also being reported in the literatures (6). Currently, there are insufficient~     evidences on the efficacy and safety of biocompatible tissue augmenting materials used for~     endoscopic correction of VUR; particularly on the new tissue bulking agents. (6) Polyacrylate~     polyalcohol copolymer (PPC)-Vantris ® (Promedon, Cordoba, Argentina) is the newest tissue~     augmenting biocompatible Acrylics used for endoscopic correction of VUR.~   "
125380|NCT01926340|"~     The study aims to examine the relationship between early maintenance therapy decisions in~     first episode psychosis, and the subsequent long-term clinical outcome at 9-10 years by~     comparing a group of patients who were randomized to discontinue (placebo) or continue~     medication (quetiapine) in the early stage of their psychotic disorders.~   "
125381|NCT01926327|"~     Osteoarthritis is the most common type of arthritis. The prevalence of osteoarthritis of the~     knee has significantly elevated in the elderly population and youth due to age and sport~     activities respectively. Our aims to treat the knee osteoarthritis are including; reduce knee~     pain and improve its function; return patients to normal daily activities and reduce health~     care costs.~      The current treatments which are already being used for osteoarthritis of the knee patients~     include:~        1. Symptomatic therapy: conservative therapies, physiotherapy, analgesics and non-steroidal~          anti-inflammatory drugs.~        2. Intra-articular injections of corticosteroids and hyaluronic acid.~        3. Current Surgical Therapy: knee arthroplasty, osteotomy, arthrodesis and debridement.~      As the low mitotic activity and lack of blood supply cause little ability for the articular~     cartilage to repair itself, so injection of platelet-rich plasma (PRP) has recently received~     much more attention due to its capacity to do self-healing in treatment of osteoarthritis of~     the knee.~      PRP consists of several concentrated growth factors in platelets of autologous blood that are~     applied to the different parts of medicine such as reconstruction of damaged tissue. Although~     platelets are well-known to involve in the blood clots formation, but current studies have~     shown that they secrete many bio-proteins which attract macrophages, mesenchymal stem cells~     and osteoblasts to remove necrotic tissue in addition to participate in healing procedure.~      This study is a prospective, randomized, controlled trial to assess The positive effects of~     platelet-rich plasma injection in 244 patients with osteoarthritis of the knee~   "
125382|NCT01926314|"~     Pregnancy and childbirth are considered as risk periods for injuries to the pelvic floor and~     development of pelvic floor dysfunction. This may leed to devastating loss of function and~     quality of life.The aim of this study is to evaluate the effect of postpartum pelvic floor~     muscle training with the device PHENIX Neuromuscular Stimulation Therapy Systems on the~     recovery of pelvic floor function for primiparous women.~   "
125383|NCT01926301|"~     The cerebrovascular autoregulation is impaired in patients with severe sepsis and septic~     shock. A continuous veno-venous hemodialysis may improve impaired cerebrovascular~     autoregulation.~      Hypothesis: continuous hemodialysis recovers impaired cerebrovascular autoregulation in~     patients with acute severe sepsis and septic shock.~   "
125384|NCT01926288|"~     The purpose of this study is to evaluate the safety and efficacy of Entecavir maleate tablets~     in Chinese patients with hepatitis B~   "
125385|NCT01926275|"~     The aim of this study is to determine whether noninvasive positive pressure ventilation with~     inspiratory muscle training can improve quality of life and respiratory muscle strength than~     noninvasive positive pressure ventilation or inspiratory muscle training alone.~   "
125386|NCT01926262|"~     The aim of this project is to investigate, whether physical training, targeted neck and~     shoulder muscles, can reduce and prevent neck pain among military helicopter pilots and~     crewmembers.~   "
125387|NCT01926249|"~     A Multicenter national prospective cohort study including at least 2300 individuals~     consecutively recruited from French Research Memory Centers and followed-up over 5 years.~   "
125388|NCT01926236|"~     The purpose of this study is to determine whether fit patients (with ECOG performance score~     of 0-1) with advanced biliary tract cancer (ABC) benefit from chemotherapy in the second-line~     setting (after prior therapy with cisplatin and gemcitabine) in terms of overall survival.~   "
125389|NCT01926223|"~     Massachusetts Healthy Families Evaluation is a randomized controlled trial of a statewide~     home visiting program for first time parents aged 20 years and under. The evaluation uses a~     mixed-method design to assess participant outcomes in five program goal areas: 1) prevention~     child abuse and neglect; 2) optimal child development; 3) educational achievement and~     economic self-sufficiency; 4) parental well-being; and 5) prevention of repeat teenaged~     births.~   "
125392|NCT01926184|"~     In the era of HIV treatment as prevention (TasP), efforts are needed to identify~     evidence-based combination prevention approaches that achieve greater decreases HIV viral~     load among populations that are more likely to engage in HIV transmission risk behavior.~     Because methamphetamine-using men who have sex with men (MSM) are at greater risk for~     acquiring and transmitting medication-resistant strains of HIV, interventions targeting~     stimulant use in this population of high-risk men could boost the effectiveness of TasP. At~     present, only conditional cash transfer approaches such as contingency management (CM) have~     demonstrated short- term efficacy in reducing stimulant use among substance-using MSM who are~     not actively seeking formal treatment. The proposed RCT will examine the efficacy of a~     positive affect intervention that is designed to optimize the effectiveness of CM to achieve~     long-term reductions in stimulant use and HIV viral load in this population. the~     investigators' team will examine the efficacy of this integrative intervention in a~     randomized controlled trial (RCT) with 230 HIV-positive, methamphetamine-using MSM. After~     enrolling in CM, participants will be randomized to receive either: 1) the positive affect~     intervention; or 2) a attention-matched control condition. Follow-up data will be collected~     at 3, 6, and 12 months post-randomization. This RCT will provide an opportunity to examine~     the efficacy of an integrative intervention designed to promote long-term reductions in HIV~     viral load as the primary outcome. Secondary outcomes that will be examined include:~     increases positive affect, reductions in stimulant use, improvements in T-helper (CD4+)~     count, and decreases HIV transmission risk behavior. Identifying an efficacious intervention~     approach to decrease HIV viral load among methamphetamine-using MSM would substantially~     support the goals of the National HIV/AIDS Strategy to reduce HIV incidence and mitigate~     HIV-related health disparities.~   "
125393|NCT01926171|"~     The purpose of this study is to evaluate the safety and efficacy of icotinib in combination~     with whole brain radiotherapy for NSCLC patients with brain metastases. The primary endpoint~     is objective response rate of intracranial lesions.~   "
125394|NCT01926158|"~     This randomized clinical trial will evaluate the efficacy of an antiresorptive osteoporosis~     drug (denosumab) in prevention of periprosthetic bone loss and in promotion of implant~     osseointegration (bone bonding) in postmenopausal women after total hip replacement. The~     investigators assume that denosumab prevents periprosthetic bone loss and enhances bone~     bonding of the hip stem in postmenopausal women.~   "
125395|NCT01926145|"~     The objective of this study is to describe: 1) Differences in perceived health at hospital~     discharge between diagnostic groups and in-hospital predicting factors. 2) Perceived health~     at hospital discharge as a predictor of morbidity and mortality after 1 and 3 years. 3) The~     association between perceived health, sick leave and health care utilization.~      The five heart centres in Denmark diagnose and treat about 50.000 patients with different~     diagnoses every year and offer both invasive and non-invasive treatment.~      Perceived health status is measured by self-reported health, quality of life, anxiety and~     depression and symptoms. Knowledge about perceived health status can help to guide inpatient~     practise and outpatient follow-up. Furthermore, it can be used to evaluate differences~     between diagnostic groups, regional differences and predicting factors for perceived health~     status at hospital discharge and long term morbidity and mortality. Also economic analysis of~     healthcare utilisation and work ability status are possible.~      Five Danish heart centres (Rigshospitalet, Gentofte Hospital, Odense University Hospital,~     Aarhus University Hospital and Aalborg University Hospital) are all including patients from~     April 2013 to April 2014. All patients discharged or transferred from one of the heart~     centres are potential participants in the study. Patients are unselected and consecutively~     included at hospital discharge. Included patients will be asked to complete and return a~     questionnaire before they leave the hospital.~      The following questionnaires will be used to measure the perceived health status of the~     patients at hospital discharge: SF-12, Hospital Anxiety and Depression Scale, EQ-5D, Brief~     Illness Perception Questionnaire, HeartQoL and Edmonton Symptom Assessment Scale. Furthermore~     14 ancillary about health and health behaviour are included in the questionnaire. This~     amounts to a total of 62 items in the questionnaire.~      The DenHeart study data collection, database development and reporting of primary outcomes~     are funded by the five participating heart centres in Denmark. Further funding for registry~     data, analyses and reporting will be applied for in external funds.~   "
125396|NCT01926132|"~     Reactive Oxygen Species (ROS) can cause oxidative damage, resulting in oxidation of lipids,~     proteins and DNA. In fatigue patients, there are some evidences of oxidative damage to DNA.~     Ascorbic acid was known to protect mitochondrial injury against oxidative stress by~     depolarizing the mitochondrial membrane. The copy number of mitochondrial DNA(mtDNA) was~     suggested mitochondrial gene stability and biogenesis and reflected mitochondrial function.~     There is no evidence ascorbic acid would decrease the mtDNA damage in fatigue patients. The~     investigators hypothesized that decreasing in mtDNA copy number in salivary and blood sample~     may be reversed by high-dose vitamin C intravenous injection in fatigue patients. The~     investigators will compare the mtDNA copy number and fatigue scale between moderate-severe~     fatigue patients and control group that had not malignant and chronic illness by a randomized~     controlled trial.~   "
125397|NCT01926119|"~     The purpose of this pilot study is to test whether Transcranial Magnetic Stimulation (TMS)~     may alleviate the symptoms of Complex Regional Pain Syndrome (CRPS). The investigators will~     test various methods of TMS in a small pilot study to investigate what methods may have~     clinical potential. This is a small pilot study to determine feasibility and signal to~     potentially inform future trials.~   "
125398|NCT01926106|"~     In the present study, we hypothesized that primary mode nIPPV initiated shortly after birth~     would decrease the incidence of intubation or death in twin infants when compared to nCPAP.~   "
125399|NCT01926093|"~     We aimed to assess the accuracy of visual and quantitative analysis performed on low~     radiation dose lung CT scan (30-60 mAs)compared with that performed on standard radiation~     dose lung CT scan (110 mAs), in ARDS patients. If the results in computing lung recruitment~     will be similar, we will be able to use Low Dose CT scan for monitoring of the evolution of~     the disease in ARDS patients.~   "
125400|NCT01926080|"~     Experts agree that neonatal death has long-term impact on parents. Many parents experience~     sadness, pain, anger, bouts of crying, and a depressed mood after the death of a child. There~     are no prospective studies that evaluate the effectiveness of bereavement management and~     follow-up on the grief process following the death of a newborn. The purpose of this study is~     to evaluate the impact of a neonatal intensive care unit (NICU) bereavement support program~     and the use of a newly designed family-centered bereavement DVD. This educational DVD~     includes personal interviews with parents, grandparents and siblings who have experienced the~     lost of a baby in the NICU.~   "
125401|NCT01926067|"~     Aim of the study: To validate accelerometers for continuous monitoring of global cardiac~     function during weaning from cardiopulmonary bypass (CPB) in cardiac surgery.~   "
125423|NCT01925781|"~     This is a randomized trial comparing electronic cigarettes (e-Cigarettes) to nicotine gum for~     smoking cessation. Participants will be randomly assigned to either e-cigarette use or~     nicotine gum use during a quit attempt. All participants will have a one hour meeting with a~     tobacco treatment specialist to develop a quit plan and set a quit date. Quit status will be~     determined at 12 weeks after the quit date. Continued use of nicotine replacement (either~     e-Cigarette or nicotine gum) and satisfaction with the treatment assignment will be~     evaluated.~   "
125424|NCT01925768|"~     The purpose of this study is to determine whether apremilast is safe and effective for~     treating patients with psoriatic arthritis.~   "
125610|NCT01923324|"~     The purpose of this study is to investigate whether pain control for patients with chronic~     pain is improved by the availability of structured telephone consultations between the~     patients' family physicians and pain physicians, compared to pain control for patients~     receiving usual care.~   "
125402|NCT01926054|"~     This is an open-label, randomized, multi-center, Phase IV study of Acthar Gel in patients~     with biopsy-proven membranous (Class V) lupus nephritis (LN) aimed at providing~     proof-of-concept data that Acthar is a safe and effective therapy for membranous LN. Class V~     LN is a secondary form of membranous nephropathy, and occurs in 8-20% of patients with LN.~      Two different doses of Acthar Gel will be tested. The active intervention phase of this study~     will take place over 6 months, and follow-up will occur over the following 6 months. Efficacy~     and safety of the use of Acthar Gel for treatment of membranous LN will be assessed and~     analyzed throughout the course of the study by laboratory testing, physical exams, and other~     evaluation tools. Subjects will be closely monitored for adverse effects associated with the~     use of Acthar gel and if necessary study drug dosing will be reduced. The anticipated~     benefits to subjects are a complete renal response rate of 40% at 6 months showing~     superiority over the published complete remission rates of the currently used~     immunosuppressive therapies, and no unexpected toxicity signals.~      Pure Class V LN affects a significant number of systemic lupus erythematosus (SLE) patients~     and although it is less aggressive than proliferative forms of LN it still causes important~     renal and non-renal morbidity and mortality over time, especially in patients who remain~     nephrotic. The therapy of Class V LN is not clear, and currently used therapies are highly~     toxic because of immunosuppression, risk of infertility, and risk of future malignancy.~     Additionally, these therapies are only modestly effective in inducing remissions of Class V~     LN. There is thus an unmet need for a more effective and less toxic treatment for Class V LN.~   "
125403|NCT01926041|"~     Diabetes mellitus (DM) has been established to contribute to cardiovascular comorbidities,~     malignancies and higher mortalities. The management of DM is not limited to aggressively~     controlling sugar levels after the diagnosis; instead, should be emphasized more on effective~     modification for prediabetics. Smoking cessation were also demonstrated to improve insulin~     resistance. Nowadays, the 2nd-generation cessation program in Taiwan brings higher~     accessibility. However, there is little evidence on the long-term health outcomes of~     combining smoking cessation and coach-assisted lifestyle change for the prediabetics in the~     community.~      The present new project extends the original pilot project (NSC 102-2628-B-002-046-MY2 and~     MOST 104-2314-B-002 -072) from August of 2013. The investigators have been making efforts to~     promote this project by cooperating with primary care doctors of the community medical groups~     and corporate nurses. Over 446 prediabetic smokers will be enrolled by July of 2017. The~     invention includes smoking cessation clinics for up to 16 weeks (from January to December of~     2017) and coach-assisted lifestyle change (from January of 2017 to July of 2020 and later)~     for every participant joining intervention. The lifestyle coaches will help the participants~     in intervention group reach the goal of at least a 7 percent weight loss within the first 6~     months. All smokers with prediabetes in intervention and self-management group are provided~     with educational materials for lifestyle change. All prediabetic smokers are prospectively~     followed up every 6 months till July of 2020 and later for smoking status, anthropometric~     indices and blood tests.~      Regarding the potential contribution to the national socio-economic development, this project~     will strengthen the motivation of smoking cessation in prediabetic smokers. Academically, cox~     regression will be used to investigate the effectiveness of the smoking cessation combined~     with coach-assisted lifestyle change on DM prevention in smokers with prediabetes. This~     prospective project will contribute to community-based diabetes research in preventive~     medicine.~   "
125404|NCT01926028|"~     This is a multi-center, randomized, double-blind, placebo-controlled study intended to assess~     the safety, tolerability and humoral and cellular immune response over a 12-month period~     after receiving one dose of either the NDV-3A vaccine, NDV-3 vaccine, or placebo. In~     addition, the clinical efficacy of NDV-3A vaccine in lowering the recurrence rate of~     vulvovaginal candidiasis (VVC) in patients with recurrent VVC (RVVC) will be evaluated~     relative to placebo.~   "
125405|NCT01926015|"~     The study will evaluate the immunogenicity of the Diphtheria, Tetanus, Pertussis and~     Inactivated Poliovirus Vaccine (DTP-IPV) with concomitant administration of RotaTeq™ (V260)~     in healthy Japanese infants. The hypothesis to be tested is that the antibody response rates~     to DTP-IPV with concomitant administration of RotaTeq™ are non-inferior to those with~     staggered administration of RotaTeq™.~   "
125406|NCT01926002|"~     The primary hypothesis of the study is single doses of MK-8351 will reduce the baseline early~     asthmatic response (EAR) as assessed by area under the curve from 0-3 hours (AUC0-3hr) of~     forced expiratory volume (FEV1) when compared to placebo.~   "
125407|NCT01925989|"~     This is a two-period study of participants with type 1 diabetes mellitus (T1DM). In each~     period, participants will receive once daily injections of stable dose LY2605541 or insulin~     glargine for 28 to 35 days followed by procedures to look at how the body uses or stores fats~     and sugars. Participants will continue to use meal time insulin throughout the study. Healthy~     participants will also enroll in the study. They will not receive any study medication.~   "
125408|NCT01925976|"~     The purpose of this study is to implement an individualized, face-to-face, parent supported~     and school-partnership dietetic intervention program to promote healthy eating habits in~     obese, Hispanic, children from low socioeconomic status due to the high predisposition to~     unhealthy eating habits and obesity in this population.~   "
125409|NCT01925963|"~     The purpose of the research study is to collect information about brain function and~     structure among active duty military personnel or civilians who are healthy. Researchers want~     to develop a database from normal volunteers that will be used in comparison with a similar~     database from active duty military with post-concussive syndrome (PCS) from a mild traumatic~     brain injury. Findings from this study may be used to design larger studies that will~     evaluate whether hyperbaric oxygen treatments actually improve PCS.~      Participants in this study will undergo numerous tests to assess physical, mental, and~     intellectual health and how they might change over time. Participants will wear heart and~     activity monitors, undergo brain imaging, provide blood and urine for laboratory testing, and~     have vision, hearing, balance, and muscle function tests. They will also complete a number of~     questionnaires and interviews. This battery of tests will be repeated twice more over the~     course of 6 months.~   "
125410|NCT01925950|"~     Use of an oral topically-active glucocorticoid with limited side effects may control the~     gastrointestinal inflammatory process of GVHD and minimize glucocorticoid exposure.~   "
125411|NCT01925937|"~     The aim of this study is to compare the effect of addition of combination of~     Atorvastatin/CoenzymeQ10 to standard congestive heart failure (CHF) treatment versus addition~     of Atorvastatin alone on CHF outcomes.~   "
125425|NCT01925755|"~     This is local prospective multicenter observational non-interventional local study. Primary~     study objective is investigate and describe prescription pattern of neurologists in secondary~     stroke or non-CNS (non-Central Nervous System) systemic embolism prevention in patients with~     AF (Atrial fibrillation) and prior stroke or TIA (Transient Ischemic attack) who treat with~     rivaroxaban at an initial visit and three follow-up visits.~   "
125412|NCT01925924|"~     Demineralization during orthodontic (brace) treatment is a common clinical problem leading to~     unsightly white or brown marks on the teeth. A recent systematic review has shown little~     evidence that current methods of delivering fluoride are effective at reducing this problem.~      Design: A multi-centre randomised single blinded controlled clinical trial will be conducted~     with two parallel groups.~      Setting: The trial patients will be treated by eight named operators on the Specialist List~     for Orthodontics held by the General Dental Council and who work either within the hospital~     service or specialist orthodontic practice. The sample size calculation suggests that each~     operator will need to treat 40 patients in the trial (approx 1 session per week) plus up to~     10 familiarisation patients before.~      Planned trial interventions: Brackets will be bonded to all teeth in front of the first~     permanent molars with either a resin-modified glass ionomer cement (Fuji Ortho LC) or a light~     cured composite control (Transbond). The material to be bonded will be allocated randomly.~      Outcome measures: The two main outcome measures will be the difference in demineralization of~     the anterior teeth before and after treatment assessed from photographs and the number of~     debonded brackets during treatment.~   "
125413|NCT01925911|"~     To evaluate the effect of IPI-145 on the pharmacokinetics of midazolam, a cytochrome P450 3A~     (CYP3A) substrate; to assess the safety and tolerability of IPI-145 when administered with~     midazolam in healthy subjects.~   "
125414|NCT01925898|"~     Sedation is often needed for young children undergoing minor procedures in the emergency~     department (ED). Oral midazolam is one of the most commonly used regimens for children~     undergoing laceration repair but its sedative efficacy was shown to be suboptimal. In only~     one randomized controlled study oral ketamine has been used successfully for procedural~     sedation for laceration repair. A recent study showed that the combination of oral midazolam~     and oral ketamine provided deeper sedation compared with oral midazolam alone. However~     children treated wuth the combination of midazolam and ketamine required longer recovery~      Hypothesis:~      Oral ketamine can provide superior sedation to oral midazolam in children requiring sedation~     for laceration repair.~   "
125415|NCT01925885|"~     -  Hypothesis: Focal Impulse and Rotor Modulation (FIRM) will substantially reduce or~          eliminate clinical atrial fibrillation in subjects with accepted indications for~          catheter ablation of paroxysmal AF, compared to standard pulmonary vein isolation.~        -  Summary: This is a prospective randomized study to assess the safety and effectiveness~          of FIRM procedures only, versus standard Pulmonary Vein Isolation (PVI) procedures for~          the treatment of symptomatic paroxysmal atrial fibrillation.~   "
125416|NCT01925872|"~     1. Clopidogrel resistance is common in patients of ischemic cerebrovascular disease.~        2. Genetic polymorphisms are the most important factors to clopidogrel resistance.~        3. The purpose of this study is to find the genes which are the related to clopidogrel~          resistance.~        4. Through gene sequencing, we can filter patient of clopidogrel resistance, so another~          drug maybe used to avoid the undesired efficacy.~   "
125417|NCT01925859|"~     To compare the pharmacokinetic properties of two different doses of EryDex (dexamethasone~     sodium phosphate encapsulated in erythrocytes) given as a single infusion in healthy~     volunteers, based on plasma concentrations of dexamethasone.~   "
125418|NCT01925846|"~     Microbial infection of the cornea, also known as microbial keratitis, causes severe corneal~     inflammation that could result in permanent visual loss. Contact lens wear is the strongest~     risk factor related to microbial keratitis in developed countries. The most commonly isolated~     pathogen of contact lens associated microbial keratitis (CLMK) is Pseudomonas aeruginosa,~     which accounts for over one third of the cases. Among the various virulence factors involved~     in the pathogenesis of pseudomonal keratitis, a secretion system known as type three~     secretion system (T3SS) secretes toxins that damage the host cells. ExoS is a bifunctional~     exotoxin with GTPase-activating protein (GAP) activity and ADP ribosyl transferase (ADPRT)~     activity. It results in an invasive phenotype of P. aeruginosa causing a relatively slower~     host cell death with intracellular invasion and possibly proliferation of bacterium. In~     contrast, ExoU expressing strains carries a cytotoxic phenotype that causes rapid host cell~     lysis due to its phospholipase activity. Previously, cytotoxic strains were reported to be~     more commonly found in patients with pseudomonal keratitis and were highly correlated with~     multidrug resistance.~      In order to understand the pathogenesis of CLMK, especially pseudomonal related CLMK, we~     proposed to recruit 180 volunteers who will wear different contact lens materials. We then~     collect the used contact lens and analyze 1) the microbiota on the used contact lens; 2) the~     bacterial-contact lens adhesion of wild strains, pscC mutant strains (T3SS needle-comples~     mutant), cytotoxic strain, and invasive strain P. aeruginosa; 3) the effect of shearing~     forces on bacterial-contact lens adhesion; 4) the bacteriocidal effect of multipurpose~     solution on different strains of P. aeruginosa.~   "
125419|NCT01925833|"~     Standard method of colonoscopy is to insert the colonoscope rapidly to reach the cecum, with~     careful inspection and polypectomy during the withdrawal phase. However, small polyps (e.g.~     <1cm) seen during insertion phase are difficult to find during withdrawal phase. Also, colon~     is in different conformation during insertion and withdrawal phases. We think careful~     inspection and polypectomy during both insertion and withdrawal can improve adenoma detection~     rate.~   "
125420|NCT01925820|"~     Currently, there are several antiviral treatments effective for suppression of viral~     replication but still failed to cure HBV infection in patients with chronic hepatitis B~     (CHB). Seven drugs have been worldwide approved for the treatment of CHB at present:~     conventional IFN (IFN) alfa, lamivudine (LAM), adefovir dipivoxil (ADV), pegylated IFN~     (Peg-IFN) alfa, entecavir (ETV), telbivudine (LdT) and tenofovir (TDF). Conventional or~     Peg-IFN alfa monotherapy has a narrow range of efficacy, is associated with several adverse~     effects and is inconvenient because of frequent injections. Oral nucleot(s)ide analogues (NA)~     are better tolerated; but virologic response to NA is frequently not durable and prolonged~     treatment is associated with the emergence of drug-resistant HBV mutants.~      Although the best treatment choice for CHB is not clarified yet, certain therapeutic concepts~     could be derived from the experience of treating patients with chronic hepatitis C or human~     immunodeficiency virus (HIV) infection. A major advancement in treating hepatitis C or HIV~     infection has been the development of combination therapy. Combination therapy has ever been~     investigated in patients with CHB, but again the optimal strategy remains to be identified.~     Entecavir, a carbocyclic deoxyguanosine NA, is one of the most potent anti-HBV agents ever~     discovered. In addition, the 6-year drug resistance rate is 1.2% in selected lamivudine-naïve~     cohorts. Pegylated interferon alfa-2a possesses both antiviral and immunomodulatory effects.~     Overall, satisfactory virologic and serologic responses could be achieved using pegylated IFN~     alfa in around 30-44% of these patients. Whether the combination therapy using Peg-IFN~     alfa-2a plus ETV can achieve a long-term beneficial effect against ETV or Peg-IFN alfa-2a~     alone is not clarified. A prior single-arm pilot study suggested that similar combination~     therapy may be beneficial in patients with CHB. In this proposal, the investigators thus~     hypothesize that the efficacy by using combination therapy with Peg-IFN alfa-2a plus~     prolonged ETV is superior to that by using ETV or Peg-IFN alfa-2a alone in that Peg-IFN may~     restore host immunity against HBV and prolonged ETV can maximize viral suppression.~      The objective of this clinical trial is to evaluate the efficacy of the combination of~     Peg-IFN alfa-2a at a dose of 180 mcg administered subcutaneously per week and ETV 0.5 mg~     daily for 48 weeks followed by ETV 0.5 mg daily monotherapy for an additional 96 weeks versus~     ETV 0.5 mg daily monotherapy for 144 weeks or Peg-IFN alfa-2a 180 mcg per week for 48 weeks~     in patients with HBeAg-negative CHB. It will be an open-label, randomized, comparative,~     multi-center clinical trial. The recruited patients will be equally randomized into three~     treatment groups. Treatment-free follow-up period will be 48 weeks in both groups of~     patients. The primary parameter is the Simultaneous achievement of HBsAg titer below 100~     IU/ml and HBV DNA below 300 IU/ml at 144 weeks after start of treatment, by an~     intention-to-treat analysis. Genotypic and virologic resistance to ETV will also be assessed~     at baseline and at end of years 1, 2 and 3.~      The investigators anticipate that the rate of HBsAg <100 IU/mL plus HBV DNA <300 IU/mL at 3~     years of the study period will be 30% for patients receiving Peg-IFN therapy and increased to~     be 45% for patients receiving Peg-IFN plus entecavir therapy. With a 5% nominal significance~     level (two-sided), 163 patients per group under a 1:1:1 ratio will provide 80% power to~     detect a difference of 15% in treatment response rates between group I and III. Because this~     will be a 4-year study for each patient, the investigators thus anticipate that the dropout~     rate may be as high as 10%. Accordingly, a total of 540 (180x3) patients will be recruited,~     in order to account for a dropout rate of up to10%.~   "
125421|NCT01925807|"~     Suicide is the second leading cause of mortality for Canadian adolescents. Mental health~     complaints are one of the leading reasons for an emergency department visit at the Children's~     Hospital of Eastern Ontario and 60% of adolescents report suicidal ideation. The goal of the~     present investigation is to test the efficacy of a brief group intervention for adolescents~     with passive suicidal ideation and their caregivers that will focus on coping, familial~     support, and emotional regulation. The investigators hypothesize that a brief group~     intervention, delivered in the weeks following presentation for crisis services, will reduce~     suicidal ideation and improve coping and familial support.~   "
125422|NCT01925794|"~     This is a prospective, multi-center, non-randomized, single arm clinical trial that will be~     conducted at up to 40 sites in the United States and Outside United States (OUS). This study~     will enroll patients with symptomatic ischemic heart disease due to a single de novo lesion~     contained within a native coronary artery with reference vessel diameter between 2.5 mm and~     4.0 mm and lesion length ≤ 24 mm that is amenable to percutaneous coronary intervention (PCI)~     and stent deployment. All patients will be followed at 30 days, 6 months, 9 months, 1 year~     and annually for 5 years post index stenting procedure.~   "
125426|NCT01925742|"~     Each year, 450,000 Canadian women become pregnant and, as a result of their participation in~     prenatal screening for Down syndrome, approximately 10,000 of them will have an amniocentesis~     (i.e. sampling of liquid surrounding the fetus) and of those, 315 will be found to carry a~     baby with Down syndrome and 70 normal pregnancies will be lost from complications of the~     procedure. It has been discovered recently that, during pregnancy, there is fetal DNA in~     maternal blood in sufficient quantities to be analysed and methods have been proposed to~     detect the presence or not of a fetus with Down syndrome using maternal blood. The~     introduction of genomic blood testing as proposed in the context of this project could lead~     to increased detection of Down syndrome, less invasive screening with 9700 amniocentesis~     avoided each year in Canada, improving the peace of mind of pregnant women, and preventing~     the accidental loss of 70 normal fetuses, at a lower overall cost than current practice.~     However, these methods still need to be validated before being appropriately introduced in~     routine care.~      The study hypothesis is that new genomics-based non-invasive methods using fetal-DNA in~     maternal blood during pregnancy can be more effective than current prenatal screening methods~     for fetal aneuploidy.~      This project will carry out an independent study that will validate the performance and~     utility of different new genomic technologies for screening in pregnant women using maternal~     blood. The team of researchers will compare the real-life performance of different~     non-invasive assays and strategies to screen for fetal aneuploidy, and identify an~     evidence-based cost-effective approach for implementation of this new technology in the~     Canadian health care system. The deliverables of this project will enable decision makers,~     pregnant women and their partner to make informed choices pertaining to prenatal genetic~     screening and diagnosis, such as screening for Down syndrome, and reduce the risk to~     pregnancies associated with amniocentesis.~   "
125427|NCT01925729|"~     This study will determine if exposure to an allergy material (ragweed) or exposure to an~     allergic-symptom-provoking substance (histamine) and medications typically used to decongest~     the nose changes the rate of blood-flow in the lining of the middle-ear. Otitis media (the~     build-up of water-like fluid in the middle-ear airspace) may occur if the blood flow in the~     lining of the middle-ear is too high and may be prevented if a way could be found to lower~     the blood flow in persons susceptible to the disease. Middle-ear blood flow is measured~     indirectly by measuring the change in middle-ear pressure while a person breathes a gas~     mixture containing nitrous oxide (laughing gas). In this study, 4 groups of subjects will~     be entered and middle-ear pressure in persons breathing a mixture of 50% Oxygen, 50% Nitrous~     Oxide (laughing gas)will be measured after exposure to one of four substances (ragweed,~     histamine,an oral decongestant, a decongestant nasal spray) and a fake medication (placebo)~     at separate test sessions. All subjects will have one set of 2 x-rays of the middle ears and~     mastoids. The group exposed to ragweed will require 3 study visits while the other 3 groups~     will have 2 study visits. From this information middle-ear blood flow will be calculated.~     This will help determine the relationship between what happens in the nose and what happens~     in the middle ear.~   "
125428|NCT01925716|"~     The objectives of this clinical trial are to assess the effects of dietary oils on blood~     lipids and other aspects of the fasting lipoprotein profile in healthy men and women with~     elevated cholesterol~   "
125429|NCT01925703|"~     Intravenous iron replacement has been shown to benefit patients with heart failure and iron~     deficiency, but the weekly outpatient regimens studied to date are impractical for many~     patients. Our purpose is to evaluate the short-term effects and safety of an accelerated~     intravenous iron regimen in hospitalized patients with these two conditions.~   "
125430|NCT01925690|"~     As many as 50% of MS patients prematurely discontinue their disease modifying medications.~     For this study, we will develop a telephone-based talk therapy intervention and then conduct~     a randomized controlled trial. Patients will be assigned to either 5 weekly 20 minute~     telephone sessions of psychotherapy or a brief education control condition. We hypothesize~     that patients undergoing phone therapy will be more likely to indicate they are interested in~     resuming taking disease modifying medications than patients given brief education and~     treatment as usual.~   "
125431|NCT01925677|"~     Feasibility study on robotic-assisted single-site donor nephrectomy utilizing da Vinci~     instrumentation and Single-Site platforms.~   "
125432|NCT01925664|"~     The goal of this study was to evaluate the impact of a doula home visiting intervention on~     young, low-income mothers' birth outcomes, breastfeeding, postpartum depressive symptoms, and~     parenting, and on their children's development.~   "
125433|NCT01925651|"~     The aim of this study is to evaluate the impact of adding bolus in adjuvant radiotherapy~     after mastectomy, in relation to the time of treatment interruption and acute effects. This~     study evaluates whether there is an increase in treatment time with the addition of the~     bolus, which can overshadow the benefit of increased dose to the skin and subcutaneous~     tissue.~   "
125434|NCT01925638|"~     The purpose of this study is to see if there is a difference between the way your body~     absorbs and distributes BAY86-9766 when given alone or in combination with ketoconazole, a~     drug which may affect how much BAY86-9766 is absorbed, distributed or eliminated from the~     body~   "
125435|NCT01925625|"~     HYPOTHESIS In a high risk population the EarlyCDT-Lung test reduces the incidence of late~     stage tumours;3 / 4 / Unclassified (U) at diagnosis compared to normal clinical practice.~   "
125436|NCT01925612|"~     This study has 3 parts. The purpose of Part 1 of this study is to assess the safety and~     efficacy of brentuximab vedotin in combination with RCHOP (rituximab, cyclophosphamide,~     doxorubicin, vincristine, and prednisone) (known as BV+RCHOP) in patients with DLBCL that~     have never been treated. Patients will be randomly assigned in a 1:1 ratio to receive RCHOP~     together with 1 of 2 doses of brentuximab vedotin. Patients will be tested to see if there is~     a difference in side effects between the 2 groups.~      The purpose of Part 2 of this study is to assess the safety and efficacy of brentuximab~     vedotin in combination with RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone)~     (known as BV+RCHP) in patients with CD30-positive DLBCL that have never been treated.~     Patients will be enrolled to receive RCHP together with 1.8mg/kg of brentuximab vedotin.~      The purpose of Part 3 of this study is to assess the safety and efficacy of BV+RCHP compared~     to standard RCHOP in patients with CD30-positive DLBCL that have never been treated. Patients~     will be randomly assigned in a 1:1 ratio to receive either BV+RCHP or RCHOP. Patients will be~     tested to see if there is a difference in side effects between the 2 groups.~   "
125437|NCT01925599|"~     The BAP1 trial will examine the blood of patients diagnosed with choroidal nevi or uveal~     melanoma for a germline BAP1 mutation and other genetic markers associated with developing~     malignancy as well as additional sequencing of the uveal melanoma genome.~   "
125438|NCT01925586|"~     This study is designed to look at whether it is feasible to observe women with atypical~     ductal hyperplasia (ADH) of the breast, or whether surgical excision is necessary.~   "
125462|NCT01925261|"~     This one-year study is designed to investigate the safety and efficacy of TPX-100, a 23-amino~     acid chondrogenic peptide, delivered by intra-articular injection, in regeneration of knee~     cartilage in subjects with bilateral osteoarthritis of the knee.~   "
125439|NCT01925573|"~     This protocol is designed to generate and provide preliminary data to determine the safety~     and activity of combination therapy using tumor treating fields (TTFields;~     Optune(NovoTTF-100A); Novocure, Haifa, Israel), a novel FDA-approved therapy utilizing~     alternating electric fields to inhibit tumor cell growth, along with bevacizumab (Avastin;~     Genentech, San Francisco, CA), a humanized monoclonal antibody that inhibits vascular~     endothelial growth factor (VEGF), and hypofractionated stereotactic radiotherapy, a~     highly-focal abbreviated course of brain irradiation, in the treatment of patients with~     bevacizumab-naive recurrent GBM. Each of these individual therapies, and also several~     combinations in doublets, has already demonstrated safety and efficacy but prospective~     clinical data for the concurrent combination of all three therapies are lacking.~   "
125440|NCT01925560|"~     The objective of this study is to assess the tolerance and utilization of agave inulin. This~     will be accomplished through analyses of breath and fecal samples to quantify fermentation~     end-products- hydrogen, carbon dioxide, and methane will be measured in the breath, and~     short-chain fatty acids, ammonia, phenol, and indole will be measured in feces. Microbial~     populations will also be measured in fecal samples.~   "
125441|NCT01925547|"~     The purpose of this study is to investigate the effect of micellar curcumin on inflammation~     and lipid metabolism markers in subjects at risk for the metabolic syndrome.~   "
125442|NCT01925534|"~     The purpose of this study is to assess whether Optiflow, a high-flow humidified oxygen~     delivery system, is superior to standard oxygen therapy during breaks off noninvasive~     ventilation in patients affected by acute respiratory failure and in respiratory distress.~     The investigators anticipate that the Optiflow will provide oxygen more effectively, be more~     comfortable and permit longer breaks off NIV, shortening the total duration of NIV.~   "
125443|NCT01925521|"~     The objective of this trial is to evaluate the safety and tolerability of single and multiple~     ascending oral doses of OPS-2071 in healthy male Korean~   "
125444|NCT01925508|"~     The purpose of this study is to verify that the implementation of a protocol physiotherapy~     musculoskeletal pain and reduces anxiety and improves quality of life in patients~     hospitalized at the clinic of high-risk pregnancies at the Hospital das Clinicas of Ribeirao~     Preto, with a diagnosis of preeclampsia and chronic hypertension with superimposed~     preeclampsia. Where patients will be recruited, answered questionnaires before and after~     application of physiotherapy protocol.~   "
125445|NCT01925495|"~     This is a study to determine if there are reflexes that detect changes in eardrum position or~     in the pressure of middle-ear gases and respond with changes in the ease by which the~     Eustachian tube is opened. The Eustachian tube is the normal tube that connects the middle~     ear to the nose. It is usually closed, but can be opened by contraction of 2 small muscles~     that surround the tube. If the Eustachian tube does not open frequently enough, the pressure~     in the middle ear will decrease, the eardrum will be pulled in toward the middle ear causing~     a hearing loss, and fluid will accumulate in the middle ear to try and stabilize its~     pressure. There is some evidence that the changes in eardrum position and middle-ear pressure~     when the Eustachian tube does not open frequently enough can be detected by the brain that,~     in turn, sends signals to the Eustachian tube and its muscles to make Eustachian tube opening~     easier. In this study, we will test this possibility.~      Specifically, in 3 experiments done on 5 different days, we will move the eardrum in and out,~     apply different pressures to the middle ear, or change the composition of the gases in the~     middle ear while we measure how difficult it is to open the Eustachian tube by increasing~     middle-ear pressure or by measuring the readiness of the Eustachian tube muscles to~     contract and open the tube.~   "
125446|NCT01925482|"~     This study will measure the speed at which gases move between the middle-ear air-space and~     the blood flowing through the middle-ear lining. The middle ear is a rigid biological gas~     pocket located behind the eardrum and is filled with the same gases as in air, primarily~     oxygen (O), nitrogen (N) and carbon dioxide (CO2), but in different proportions. The middle~     ear is lined by a thin layer of cells overlying tissues that surround blood vessels. The~     blood that flows through the middle-ear lining also contains these same gases but at~     different proportions from both the atmosphere (room air) and middle ear. Because of the~     differences in the proportions of these gases, each gas tends to flow between the middle ear~     and blood trying to make the proportions of gases in those compartments the same. This flow~     of gases to and from the middle ear changes the middle-ear pressure. If the middle-ear~     pressure decreases much below the air pressure of the atmosphere, the ability to hear sounds~     is impaired and fluid can build up in the middle ear. It is expected that each different gas~     will move between the middle ear and blood at a different speed, but it is not known what~     those speeds are for any of the gases. It is also expected that those speeds will be~     different for ears that have had middle-ear disease and those that have not. In this study,~     we will measure the speed of nitrogen, oxygen and carbon dioxide exchanges in both directions~     between the middle ear and blood. To do this, the gas mixture in the middle ear will be~     changed so that there is movement of only one gas for each experiment and then measure the~     change in the amount of the gas in the middle ear. This can be done using a special~     instrument called a mass spectrometer if there is an open, working tympanostomy (ventilation)~     tube, a small plastic tube, in the eardrum. For all participants in this study, we will~     conduct 6 experiments lasting about 2 hours each to measure the speed of nitrogen, oxygen and~     carbon dioxide flow. Subjects with and without tympanostomy tubes will be recruited. Those~     without a tube will have a tube inserted in one ear for study purposes and it will be removed~     at the end of the study; these subjects will be followed weekly until the hole in the eardrum~     (where the tube was) is closed.~   "
125447|NCT01925469|"~     The objective of this study is to assess the utility of benzocaine spray versus a placebo~     spray in alleviating pain during and after hysterosalpingogram (HSG).~   "
125448|NCT01925456|"~     A. Objectives & Hypothesis Overactive bladder (OAB) affects over 10 million adults in the~     United States and each year substantial costs are incurred from private and public funds to~     test the efficacy of new and existing drugs for OAB.14 However, effectiveness and adherence~     data from traditional clinical trials are not generalizable to clinical practice.3, 4 In an~     era of limited resources and competing demands, it is essential that cost-effectiveness data~     from clinical trials be generalizable to the clinical world. Pragmatic clinical trials~     measure the effectiveness of treatments in real clinical practice, and in the full spectrum~     of patients that require treatment.5 Pragmatic trials require patient reported outcomes that~     are valid but have low patient burden.5 The conduct of pragmatic clinical trials for OAB has~     been limited by a lack of instruments that have demonstrable validity and reliability in the~     typical clinical setting Pill counts, used to measure primary outcomes in most traditional~     trials, are burdensome in the clinical setting.1610 The optimal instrument for measuring~     utility scores, general quality of life scores for cost-effectiveness analyses for OAB, is~     also not known.~      Although poor adherence carries the potential for continued suffering for patients and wasted~     health care resources, there is a lack of data on the clinical and economic impact of poor~     adherence to treatment for OAB in real-world clinical practice. We have published preliminary~     data that underscores the role of adherence and utilities in the treatment of OAB. 3 Our~     hypothesis is that effectiveness, adherence, and utility preference scores can be measured~     using pragmatic patient reported instruments and that poor adherence is associated with lower~     effectiveness and quality of life in adults with OAB in a clinical setting. Specifically, the~     overriding goal of this proposal is to validate pragmatic instruments to measure~     effectiveness, adherence and utility preference scores and obtain preliminary data on the~     effect of adherence and quality of life in adults undergoing treatment for overactive bladder~     in a clinical setting.~   "
125449|NCT01925443|"~     The low level laser therapy is able to improve immediately and long term (after 4 weeks of~     treatment, 3 days per week resulting in 12 applications of low level laser therapy)~     isokinetic muscle performance of the quadriceps femoris muscle (peak torque, total muscular~     work , maximum power and fatigue index - normalized by body weight) pre-exercise concentric~     isokinetic quadriceps femoris muscle in subjects with diabetes mellitus~     non-insulin-dependent.~   "
125450|NCT01925430|"~     A new device is being developed to screen for sleep-breathing disorders. Within this device~     is a new software algorithm which will determine sleep/wake states. The aim of this study is~     to evaluate the performance of this new algorithm. This prototype will be compared against a~     commercially available device which monitors sleep/wake patterns. Volunteers will be asked to~     wear the prototype and comparative devices for 1-2 nights. The data from both devices will be~     downloaded after the completion of the study and analysis wil be performed to compare the two~     recordings.~   "
125451|NCT01925417|"~     This study will assess the safety of a new biologic drug, RBX2660 (microbiota suspension) as~     a treatment for recurrent Clostridium difficile-associated diarrhea (CDAD), which is the~     primary symptom of recurrent Clostridium difficile infection. All eligible subjects will~     receive RBX2660.~   "
125452|NCT01925404|"~     Encouraging greater levels of physical activity is critical to improving health among~     Americans, who are largely sedentary. Neighborhood parks are resources for physical activity~     that are available to most Americans within a couple miles of their homes, yet many residents~     are unaware of the programs and facilities available. Previous research indicates that park~     use is related to park programming and outreach. Because funding for parks is limited,~     low-cost interventions are needed to attract more people to parks to engage in~     moderate-to-vigorous physical activity. While many community-based organizations would like~     to invest in efforts that increase physical activity, few low-cost park programs are~     documented to be both scalable and cost-effective. Effective programs that can be replicated~     to make population-level impacts are needed. The goal of this study is to develop and test 2~     low-cost community-level approaches, free exercise classes vs. a frequent user program, to~     promoting physical activity, singly and in combination, in 48 park settings in Los Angeles~     low-income neighborhoods.~   "
125453|NCT01925391|"~     Pediatric glaucoma is a rare but potentially blinding condition where the pressure in the eye~     is too high. Diagnosis is based on intraocular pressure (IOP) and assessment of the optic~     nerve, cornea and other structures. Accurate intraocular pressure measurements in young~     children is often impossible to obtain in an office setting. Children need sedation or~     general anesthesia to determine IOP. All volatile general anesthetics affect the IOP. Nitrous~     Oxide, a weak volatile anesthetic, does not affect IOP in healthy adults. Since Nitrous Oxide~     has shown to be safe and effective in a variety of practice environments, we want to evaluate~     the use of nitrous oxide in oxygen to obtain IOP measurements in children.~   "
125454|NCT01925378|"~     Preliminary data showed that Nelfinavir has selective apoptotic effects on HPV+ cervical~     tumor cell lines. Furthermore, in a Phase I clinical trial, the combination of NFV and~     chemoradiotherapy showed acceptable toxicity and promising activity in patients with~     pancreatic cancer. Therefore, for the proposed research, the principal investigator will use~     a single-arm Phase II intervention trial study design with focus on the efficacy of NFV to~     induce complete or partial remission of CIN 2/3 or CIN 3 as well as biomarker evaluation.~   "
125455|NCT01925365|"~     Intake of whole grain cereals has been associated with reducing the risk of hyperlipidaemia~     and heart disease, however the mechanisms by which oats or oat fractions exert this effect is~     not totally clear. Furthermore, several large epidemiological studies and a number of recent~     meta-analyses of nutritional interventions have reported a positive association between~     increased whole grain intake and reduced risk of developing a range of chronic diseases.~     Recognising the important role of the gut microbiota in metabolism and metabolic disease~     risk, we examined the impact of whole grain oats on the human gut microbiota and~     cardio-metabolic risk factors.~      The main aims of this human study is to determine the effectiveness of a low GI whole grain~     oats breakfast cereal compared to a high GI, refined breakfast cereal to beneficially~     modulate gut microbiota and its metabolic output, plasma lipids, gut satiety hormones and~     inflammation markers in an at risk of cardio-metabolic disease population~   "
125456|NCT01925352|"~     To explore the safety and efficiency of adenovirus-hepatocyte growth factor(Ad-HGF) treatment~     in ischemic heart disease.~   "
125457|NCT01925339|"~     The purpose of this study is to compare two different timings of restoring dental implants~     that are placed right after tooth extraction: The test group will have the provisional crown~     placed at the time of implant placement. The control group will have the tooth removed and~     the implant placed at the same appointment but restorations placed after 4 months. Both~     procedures currently are accepted methods for replacing missing teeth but direct comparisons~     of the two procedures are lacking. The results of this study should aid clinicians in~     selecting the best timing for restoring implants for their patients. The hypothesis is that~     immediate restoration might increase aesthetic outcomes, e.g. less mucosal recession.~   "
125458|NCT01925313|"~     Study objectives~        -  To compare the safety and pharmacokinetic properties of CJ-30044 and bepotastine~          besylate after a single oral administration in healthy male volunteers.~        -  To evaluate the food-effect on pharmacokinetics of CJ-30044 after a single oral~          administration in healthy male volunteers.~   "
125459|NCT01925300|"~     This study is designated to evaluate the pharmacokinetic interactions of bisoprolol and~     rosuvastatin in healthy male volunteers.~   "
125460|NCT01925287|"~     Background: The oral bioavailability of curcumin is low due to its limited intestinal uptake,~     rapid metabolism and excretion from the body. Considering its potent reported~     health-beneficial properties, researchers have tried to increase its bioavailability as a~     means to enhance its biological activities.~      Objective: The aim of the project was to develop novel curcumin formulations with enhanced~     oral bioavailability and to study the safety of the formulations and potential~     sex-differences in humans.~      Design: In this single-blind crossover study with three arms separated by ≥1-week washout~     periods, healthy subjects (13 women, 10 men) were provided standardized meals and took, in~     random order, a single oral dose of 500 mg curcumin as native powder, micronized powder, or~     liquid micelles. Blood and urine samples were collected in intervals for 24 h and total~     curcumin, demethoxycurcumin, and bis-demethoxycurcumin were quantified.~   "
125461|NCT01925274|"~     This study will investigate whether the combination of PF-05212384 plus Irinotecan improves~     progression free survival in patients with KRAS and NRAS wild type metastatic colorectal~     cancer when compared with the combination of cetuximab plus Irinotecan. A Japanese Lead in~     Cohort will assess the safety of the combination of PF-05212384 + irinotecan in patients~     enrolled at Japanese sites.~   "
125464|NCT01925235|"~     Patients with impaired renal function are at elevated risk for development of acute kidney~     injury (AKI). AKI is associated with increased risk for cardiovascular morbidity and~     mortality. Effective AKI prevention strategies are needed. Remote ischemic preconditioning~     (RIPC) is a novel and successful strategy to attenuate contrast medium induced AKI in~     patients undergoing elective coronary angiography.~      The retrospective RenPro-TAVI Trial was designed to test the hypothesis whether remote~     ischemic preconditioning might attenuate kidney injury in patients receiving transcatheter~     aortic valve implantation (TAVI).~      Patients with impaired renal function undergoing TAVI will be evaluated in respect whether~     they received remote ischemic preconditioning before the procedure or not. This study will~     give insight if RIPC might be beneficial in these patients.~   "
125465|NCT01925222|"~     The purpose of this study is to assess the direct effects of the ten-valent pneumococcal~     conjugate vaccine administered to infants on nasopharyngeal carriage at 3 to 5 years of age.~      These children have been vaccinated in infancy in the cluster-randomized Finnish Invasive~     pneumococcal Disease (FinIP) Trial (a separate protocol reported at ClinicalTrials.gov~     Identifier:NCT00861380) during 2009 to 2011.~      Also the indirect effect on nasopharyngeal carriage will be assessed on vaccinees' elder~     non-vaccinated siblings aged 5 to 9 years.~   "
125466|NCT01925209|"~     This study evaluated the efficacy, safety and tolerability of multiple doses of~     bimagrumab/BYM338 vs placebo, when administered intravenously (i.v.), on physical function,~     muscle strength, and mobility in patients with sporadic inclusion body myositis (sIBM).~   "
125467|NCT01925196|"~     Background:~      - Some people have a mutation in the C9ORF72 gene that causes amyotrophic lateral sclerosis~     (ALS) or frontotemporal dementia (FTD). The mutation causes a small piece of DNA to repeat~     itself thousands of times. The C9ORF gene mutation mostly occurs in families. In those~     families, some persons have ALS and others have FTD. Occasionally the C9ORF gene mutation~     occurs in persons without a family history. Researchers want to understand how this gene~     causes different diseases. They will study how symptoms caused by the C9ORF gene develop and~     change over time. They will measure symptoms that occur in ALS and in FTD. In particular,~     they will measure strength, ability to move, thinking, and memory. They will also see if~     other tests are associated with progression of disease. These tests, called biomarkers, may~     help detect or measure C9ORF72 disease in the future.~      Objectives:~      - To understand how symptoms change over time in people with mutations in a gene called~     C9ORF72, which causes ALS and FTD.~      Eligibility:~      - Adults over age 18 who have this genetic mutation~      Design:~        -  Participants will have up to 4 in-person visits and 3 telephone interviews over 3 years.~          Each in-person visit may take place over several days. They may be either inpatient or~          outpatient visits.~        -  At each visit, participants will undergo a series of brain, language, and behavior~          tests. These will include:~        -  Magnetic resonance imaging (MRI) of the brain. This uses magnets, radio waves, and~          computers to produce detailed pictures of the brain.~        -  Collecting spinal fluid. The clinician will make the participant s back numb and then~          insert a needle to collect fluid.~      <TAB>- Blood samples will be taken.~      <TAB>- Participants will be asked to perform several language and movement tests.~      <TAB>- Small skin samples will be taken on one visit~      - Between visits, participants will answer questions about their health over the phone 3~     times.~   "
125468|NCT01925183|"~     Response-guided triple-therapy with boceprevir (BOC) in combination with pegylated interferon~     (PEGIFN) and ribavirin (RBV) is the current standard of care for HIV-negative patients~     infected with hepatitis C genotype (HCV-GT) 1. In contrast, in HIV-positive patients, a fixed~     treatment duration of 48 weeks is used.~      The aim of this study is to assess efficacy and safety of response-guided triple-therapy with~     BOC in combination with PEGIFN and RBV in HIV-positive patients. Thus, treatment duration~     will be individualized based on HCV-RNA negativity at treatment week 8 (W8). All patients~     will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at W8 will be~     treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment~     duration of 28 weeks, while patients with detectable HCV-RNA at W8 will receive 44 weeks of~     BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks.~   "
125469|NCT01925170|"~     A new test for breast cancer screening, molecular breast imaging (MBI) may be more sensitive~     than mammography for detecting breast cancer in women with dense breasts. The purpose of this~     study is to see if MBI using a low dose of gamma radiation can find cancers not seen on~     mammography.~      Hypotheses: 1. Low-Dose MBI has a significantly higher sensitivity and specificity and equal~     or higher positive predictive value than SM in women age 40 and older with mammographically~     dense breasts. 2. Low-dose MBI has comparable sensitivity and specificity to that previously~     achieved with MBI using a higher dose of radiation. 3. MBI produces a low false positive rate~     (specificity >90%) that permits its use as a screening tool in this patient population.~   "
125470|NCT01925157|"~     The main purpose of this study is to evaluate the safety of the study drug known as LY3090106~     in healthy participants and in participants with RA who are having an inadequate response to~     methotrexate (MTX). The study will investigate how the body processes the study drug and how~     the study drug affects the body. The study will last about 3 months for each participant.~   "
125471|NCT01925144|"~     The main purpose of this study is to find out how the body will react to a study drug called~     baricitinib when taken with another drug called omeprazole.~      For each participant, this study will include 2 periods in fixed order. The study will last~     approximately 25 days, not including screening.~   "
125472|NCT01925131|"~     This phase I trial studies the side effects and best dose of inotuzumab ozogamicin when given~     together with combination chemotherapy in treating patients with relapsed or refractory acute~     leukemia. Immunotoxins, such as inotuzumab ozogamicin, can find cancer cells that express~     cluster of differentiation (CD)22 and kill them without harming normal cells. Drugs used in~     chemotherapy, such as cyclophosphamide, vincristine sulfate, and prednisone, work in~     different ways to stop the growth of cancer cells, either by killing the cells or by stopping~     them from dividing. Giving inotuzumab ozogamicin together with combination chemotherapy may~     kill more cancer cells.~   "
125473|NCT01925118|"~     Partially HLA-matched irradiated donor lymphcyte infusion alone resulted in 27% overall~     response rate (ORR) in advanced renal cell carcinoma without significant toxicities. In~     addition, high-dose interleukin-2 (IL-2)showed an ORR of 6-21% in metastatic melanoma or~     renal cell carcinoma with a durable response in patients who achieved complete remission.~     Therefore, irradiated donor lymphocyte infusion plus high-dose IL-2 might show a synergistic~     anti-tumor activity agaist relapsed or metastatic melanoma or renal cell carcinoma.~   "
125487|NCT01924936|"~     In the United States in 2010, 38,000 people died from suicide and it is our nation's 10~     leading cause of death. Suicide prevention is a national priority and yet secondary~     prevention programs targeting those most at risk are lacking. The purpose of the current~     research is to develop and pilot test three promising suicide prevention programs that, if~     found acceptable to high-risk individuals, could be further evaluated and eventually offered~     broadly and affordably to the public.~   "
125474|NCT01925105|"~     Like most developed countries the population of Sweden is getting older and consequently the~     number of individuals with chronic diseases will be an increasing challenge for its~     healthcare system. To improve care of the frail elderly, wards with a coordinated~     multidisciplinary team and multidisciplinary mobile teams were established several years ago.~     Treatment and follow up is planned in accordance to the patients' medical, psychological and~     functional capabilities (Comprehensive Geriatric Assessment = CGA). There are to our~     knowledge only few studies concerning CGA applicable to Swedish conditions. We plan to~     conduct a Swedish study that evaluates if care and treatment with a modified CGA-model in an~     outpatient setting can improve quality of life for frail older people.~   "
125475|NCT01925092|"~     Study objectives are to obtain safety, pharmacokinetic, and pharmacodynamic data on the~     effect of mifepristone on glucose metabolism, body weight and the growth-hormone-IGF in~     children with refractory Cushing's disease.~   "
125476|NCT01925079|"~     Among the patients with coronary heart disease, those with ACS (acute coronary syndrome) are~     extremely high-risk patients. Therefore, management outside hospital, especially the regular~     administration of drugs, is vital to prevent the recurrence of cardiovascular events.~     However, most patients often fail to stay on a long-term administration regimen, especially~     the administration of statins. According to the statistics, the average duration adhered with~     statin in patients with ACS is less than 3 months, use of statin at hospital discharge was~     only 80% and 65% in 6 month, with a very low LDL-C control rate (about 11% at 6 months),~     which poses a threat to the recurrence rate of cardiovascular events in patients with ACS.~      It was found in previous studies that there were many factors influencing patients'~     compliance, in which patients' refusing to take medicine accounted for a higher proportion.~     It suggests that patient had not recognized the importance of long-term administration.~     Therefore, it is extremely important for physicians to strengthen patient education and~     regular follow-up visits during disease management. Moreover, the effectiveness of patient~     education during chronic disease management has already been proved in some studies abroad,~     and the interventional effect of multiple patient education process outweighs that of single~     approach education.~      Thus, we intend to conduct a randomized and controlled study to explore the effect of~     multi-channel intensive patient education on LDL-C target achieving rate and statin adherence~     in patients with ACS in China.~   "
125477|NCT01925066|"~     The purpose of this study is to determine whether aerosolized vancomycin is effective in the~     treatment of methicillin-resistant staphylococcus aureus pneumonia under mechanical~     ventilation.~   "
125478|NCT01925053|"~     This exploratory study is designed to compare the gastric layering and rates of emptying and~     by inference rates of digestion of a Palaeolithic inspired meal and a reference meal. Two~     types of meals, one high in fruit and vegetables will be used, and one based on WHO~     nutritional guidelines. Previous data suggests that the former meal releases nutrients more~     slowly than the latter. On each of two study days, a total of 11 MRI scans will be taken, 1~     baseline and 10 post meal, to assess gastric layering and emptying. Participants will also be~     asked to complete a questionnaire at predetermined times to assess feelings of satiation.~   "
125479|NCT01925040|"~     The purpose of this study is to compare the clinical performance of a new resin based filling~     material to an established resin-based filling material in posterior teeth at 2 different~     study centers.~   "
125480|NCT01925027|"~     Our hypothesis is to test that 1) The safety and efficacy of Nano+ DES in patients with de~     novo lesions; 2) A low neointimal hyperplasia after Nano+ DES implantation due to its~     effective and sufficient antiproliferative drug; 3) A very high coverage and an improved~     early arterial healing after Nano+ DES implantation due to polymer-free; 4) The safety of~     clopidogrel treatment discontinuation at 3 months when OCT results are defined as optimal.~   "
125481|NCT01925014|"~     To determine whether low-dose (LD) CT is noninferior to standard-dose (SD) computed~     tomography (CT) as the first-line imaging test in adolescents and young adults in regard to~     negative appendectomy rate (NAR).~   "
125482|NCT01925001|"~     Sickle Cell disease is caused by an inherited hemoglobin disorder. Healthy red blood cells~     are discoid and can deform and move through small blood vessels to carry oxygen to all parts~     of the body. In Sickle Cell disease, as red blood cells circulate and oxygen is released, the~     deoxygenated abnormal Hemoglobin S can begin to polymerize and cause red cells to become~     sticky and elongated. These sickled red cells are less flexible and will obstruct small~     blood vessels and prevent normal red cells from circulating freely, which limits oxygen~     delivery to tissues and organs. This is known as a sickling crisis or vaso-occlusive~     crisis and is the leading cause of hospitalization in patients with Sickle Cell disease.~      Patients suffering from a sickle crisis experience severe pain and are at risk of stroke,~     heart attack or even death. Current therapy is limited to hydration and symptomatic pain~     relief. The administration of MP4CO as an adjunct treatment to standard therapy may alleviate~     pain associated with a sickling crisis and potentially reduce the severity and duration of a~     crisis. This may shorten the time in hospital and potentially improve the quality of life for~     patients with sickle cell anemia.~   "
125483|NCT01924988|"~     This is a Phase I/II investigator sponsored FDA-approved Investigational Device Exemption~     protocol, with the primary goal of determining the safety of prostatic artery embolization~     (PAE) for benign prostatic hyperplasia. Our primary goal is to document the frequency of side~     effects, particularly bladder and rectal complications, which may occur as a result of this~     procedure. Secondarily, the study will provide preliminary data to determine its~     effectiveness in diminishing obstructive symptoms associated with BPH.~   "
125484|NCT01924975|"~     The purpose of this study is to compare the two different saphenous vein cannulation~     techniques; real-time ultrasound image-guided technique (Ultrasound group) vs. traditional~     landmark technique (Landmark group).~   "
125485|NCT01924962|"~     The study is a randomised comparison of recanalisation of chronic occluded coronary arteries~     with implantation of Sirolimus eluting stents and medical therapy. Myocardial function and~     scar-size are determinated by using magnetic resonance imaging. The study hypothesis is the~     superiority of medical therapy over revascularisation.~   "
125486|NCT01924949|"~     This study is to evaluate the antiviral efficacy, safety, and tolerability of~     ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with nosocomial~     genotype 1 hepatitis C virus (HCV) infection.~   "
125489|NCT01924910|"~     The purpose of this study is to determine if a single dose of vitamin D administered orally~     in the fall will provide adequate vitamin D in healthy individuals for the duration of the~     winter, during which vitamin D levels are known to decrease. The investigators are also~     interested in finding out if this level of vitamin D will provide adequate levels for the~     remainder of the year. While the benefits of once-yearly vitamin D administration are clear~     for patients with osteoporosis, osteomalacia, rickets, and other conditions associated with~     vitamin D deficiency and high bone turn-over, studies have not been performed in which high~     doses of vitamin D were used to prevent the seasonal decline of vitamin D concentrations in~     healthy individuals. These findings could provide evidence to support vitamin D~     administration to healthy individuals in the wintertime to improve health outcomes, and~     provide the basis for additional studies in both healthy and sick populations.~   "
125490|NCT01924897|"~     Colorectal Surgery Preoperative Exercise Training is a study being run by the colorectal~     surgery team at the Norfolk and Norwich University Hospital and the University of East Anglia~     to look at the role of exercise before surgery to improve recovery following an operation.~      Having an operation to remove part of the bowel puts physical stress on the body. We know~     that training can help the body cope with physical stress in the same way that an athlete~     trains before a competition. We hypothesise that the body may recover more quickly if it is~     trained prior to an operation with regular and simple exercises.~      Cardiopulmonary exercise testing (CPET) is used to evaluate the function of the lungs, heart~     and muscles at rest and during exercise. CPET testing is often done as part of standard~     pre-operative assessment in many hospitals for patients before undergoing major surgery. Some~     studies have demonstrated that CPET can be used to predict outcomes following surgery (such~     as time taken till discharge, complication rates).~      The study consists of two parts:~      Study 1) CPET variables to predict outcomes in surgery - patients will undergo a CPET test to~     determine baseline fitness. Blood tests will be taken around the time of surgery to examine~     whether biochemical markers in the bloodstream (when used in combination with results from~     the CPET test) can predict outcomes and recovery following colorectal surgery. Patients will~     then be monitored to assess their speed of recovery and rate of complications following~     surgery.~      This will enable us to determine which CPET variables or combination of variables are most~     useful in the prediction of post-operative complications following colorectal surgery.~      2) The second study will consist of an exercise intervention involving several sessions of~     supervised exercise in a laboratory. Before and at the end the exercise training regime, CPET~     measurements will be taken to see if fitness has improved with exercise.~      This part of of the study is to determine if it is feasible to implement a structured,~     supervised exercise programme for patients awaiting elective colorectal cancer surgery. The~     results of this study will be used to inform a larger randomised controlled trial to examine~     the influence of exercise on CPET variables and postoperative outcomes.~   "
125491|NCT01924884|"~     The goal of this study is to present a large single-institution experience reporting surgical~     site infection rates in patients who have undergone intra-abdominal surgery followed by wound~     closure with Negative Pressure Wound Therapy. A retrospective review of patients' charts will~     be conducted to analyze surgical site infection rates between wound closure with and without~     Negative Pressure Wound Therapy (NPWT). American College of Surgeons National Quality~     Improvement Program data from previous standard of care (primary closure after colorectal~     surgery) will be used for comparison with newly adopted standard of care treatment regimen~     (wound closure with NPWT).~      Data on patients who underwent intra-abdominal surgery will be retrospectively collected and~     a database will be created. These individuals will be identified through medical records and~     recontacted by mail and/or phone to collect study data.~      Finally, patients newly referred to the Principal Investigator for intra-abdominal surgery~     will be enrolled in the database. After giving informed consent, data on surgical site~     infection rates and outcomes will be collected. Longitudinal outcomes will be assessed at 30~     days, 6 months, and 12 months post-operatively. These patients' outcomes will be compared to~     a group of patients treated by the Principal Investigator who also underwent intra-abdominal~     surgery without Negative Pressure Wound Therapy. We hypothesize that fewer patients treated~     with negative pressure wound therapy following intra-abdominal surgery will develop surgical~     site infections than patients who had intra-abdominal surgery but were not treated with~     Negative Pressure Wound Therapy.~   "
125492|NCT01924871|"~     It has been reported that deep extubation can reduce cardiopulmonary complication against~     endotracheal tube extubation during emergence from general anesthesia. The investigators~     hypothesized that using desflurane with target controlled infusion of remifentanil is more~     effective than using desflurane alone during deep extubation. The purpose of this study is to~     evaluate the effect of remifentanil to prevent respiratory complication (etc. coughing)~     during emergence from general anesthesia.~   "
125493|NCT01924858|"~     This is an open label, PET study in healthy male subjects to determine if GSK2647544 is able~     to cross the blood-brain-barrier. The study will use GSK2647544 radiolabelled with~     fluorine-18 ([18F] GSK2647544) to determine the ratio of the concentration of the compound in~     tissue to that in plasma at equilibrium, expressed as the PET volume of distribution (VT).~     The study will consist of at least four visits; 2 screening visits, scanning day and~     follow-up. On Day 1 (scanning day) the subject will receive a single oral dose of GSK2647544~     (100 mg) followed approximately 2 hours later by a single intravenous (IV) infusion of~     [18F]-GSK2647544 and a dynamic PET scan. Arterial and venous blood sampling will be used to~     determine the plasma kinetics of [18F]-GSK2647544 and unlabeled GSK2647544. In addition, each~     subject will undergo a structural magnetic resonance imaging (MRI) scan of the brain to aid~     in the definition of neuroanatomy. The dose of GSK2647544 was selected based on the review of~     the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) data obtained in~     the first time in human (FTIH) study.~   "
125494|NCT01924845|"~     Study 701-301 is a single-arm, open-label, switchover study in patients with late-onset Pompe~     disease who have been receiving treatment with recombinant human acid alpha-glucosidase~     (rhGAA) for 48 weeks or longer. Ambulatory patients who have mild to moderate respiratory~     impairment will switch directly to receive BMN 701 20 mg/kg by IV infusion every other week.~     All participants will receive active drug. No dose of existing therapy will be missed -~     experimental drug is started immediately.~   "
125495|NCT01924832|"~     The primary objective of this study is to evaluate the pharmacokinetics (PK) profile of~     monomethyl fumarate (MMF) following delivery of BG00012 (dimethyl fumarate, DMF) 120 mg (Part~     1) and BG00012 240 mg (Part 2) to varying regions within the GI tract in healthy volunteers.~     The secondary objective of this study is to evaluate the safety and tolerability profile~     following the delivery of BG00012 120 mg (Part 1) and BG00012 240 mg (Part 2) to varying~     regions within the GI tract in healthy volunteers.~   "
125511|NCT01924624|"~     Postoperative recurrence of hepatocellular carcinoma (HCC) is a major problem after surgical~     resection. To date, adjuvant chemotherapy or other adjuvant modalities have not been proven~     effective in preventing or delaying recurrence. The aim of this prospective randomized study~     was to evaluate the effectiveness of Thalidomide as a postoperative adjuvant regimen in~     inhibiting the recurrence of HCC~   "
125496|NCT01924819|"~     Gastric cancer remains a significant global public health problem. Although in developed~     countries its incidence has dramatically decreased, on a worldwide scale it is still a~     leading cause of cancer-related deaths. Surgery is the only potentially curative treatment~     for gastric cancer. Although the survival rates for patients with early stage disease (stage~     1A and 1B) are good, this subgroup of patients constitutes only 20% of those undergoing~     resection. The majority of patients will have locally advanced or metastatic disease at~     presentation, which has an extremely poor prognosis. The current five-year survival rate for~     gastric cancer in Western countries is approximately 20-30%, a figure that has improved~     little over the past 30 years. The intervention arm in TOPGEAR consists of pre-operative~     chemotherapy, pre-operative chemoradiotherapy, surgery and post-operative chemotherapy. The~     control arm consists of pre-operative chemotherapy, surgery and post-operative chemotherapy.~     The primary objective of TOPGEAR is to investigate whether the addition of chemoradiotherapy~     to chemotherapy is superior to chemotherapy alone in the neoadjuvant setting by improving~     pathological complete response rates in the first instance, and subsequently overall~     survival, in patients undergoing adequate surgery (D1+ dissection) for resectable gastric~     cancer.~   "
125497|NCT01924806|"~     A Pilot Study of the WoundWand™ Debridement Device on Infection Prevention~   "
125498|NCT01924793|"~     This protocol will seek to enroll up to 60 immunocompromised subjects diagnosed with~     parainfluenza infection.~      All subjects will have additional PK and Immunogenicity blood samples collected.~   "
125499|NCT01924780|"~     This will be a two-stage study to test whether t-VNS using the NEMOS device can activate the~     CAP and reduce markers of systemic inflammation. Stage A (healthy volunteers) stage B~     (patients with Juvenile Idiopathic Arthritis).~      Stage A: healthy human volunteers. A randomized, single blind, three-period crossover design~     comparing the CAP activation effect of 10 minutes (active) versus 60 minutes (active) versus~     10 minutes (sham) stimulation with the NEMOS device. CAP activation will be assessed by~     reduction in the in vitro release of LPS-inducible cytokines from whole blood.~      Analysis of the reduction in whole blood cytokine release assay after 10 versus 60 minutes of~     stimulation, and the kinetics of the nadir of the whole blood cytokine release assay will~     inform the selection of dose duration and sampling time for Stage B. Performing this more~     extensive exploration of dose duration and kinetics in adults will allow one dose, and a~     single optimal sampling time in the JIA patients, thus minimizing blood drawing and~     discomfort in these children.~      Stage B will be performed in patients with JIA. This will be an open label design examining~     the effect of the optimal dose duration (either 10 minutes or 60 minutes of stimulation, as~     determined by results of Stage A). All information regarding Stage B will be registered in a~     separate registration at clincialtrials.gov. in order to keep accuracy. All details below~     concerns only Stage A.~   "
125500|NCT01924767|"~     To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 10773 with~     repeat dosing for eight days and the exploration of the pharmacokinetics and pharmacodynamics~     of BI 10773 after multiple dosing, including dose proportionality and assessment of steady~     state.~   "
125501|NCT01924754|"~     In collaboration with the Thai Red Cross AIDS Research Centre, the investigators are~     performing a study of 2 new HPV vaccine delivery regimens in healthy young Thai women. The~     study will be performed in Bangkok. The investigators will be testing the serum from these~     women at UCSF for HPV antibodies to measure the strength of their response to the vaccine.~   "
125502|NCT01924741|"~     Recently a new method of induce similar hypertrophy in the liver as is observed after~     hepatectomy has been described and was given the eponym ALLPS. ALPPS stands for~     Associating Liver Partition with Portal Vein Ligation for Staged Hepatectomy (ALPPS).~      Since the procedure is used worldwide this international registry was created to enable~     tracking of cases performed worldwide for safety and outcomes and innovations by the groups~     involved as well as allows a non-randomized comparison to the conventional methods of portal~     vein occlusion.~   "
125503|NCT01924728|"~     The aim of the study is to investigate the effects of QRS®-1010 PelviCenter in female~     patients with stress urinary incontinence.~      Based on the available data on magnetic stimulation, the investigators hypothesize that~     magnetic stimulation via QRS®-1010 PelviCenter will reduce the number and amount of urinary~     leakage upon exertion as well as improve patients' quality of life.~   "
125504|NCT01924715|"~     Objective: To evaluate whether or not cases treated with Intensive Short-term Dynamic~     Psychotherapy (ISTDP) facilitate healthcare cost reduction, whether any observed reduction is~     greater than that of a control group and whether any such gains would be maintained in follow~     up.~      Design: A quasi-experimental design was employed in which pre and post healthcare cost and~     usage data were extracted for all ISTDP treated cases from 1999 to 2008 and compared to~     parallel measures of a control group of cases referred but never treated.~   "
125505|NCT01924702|"~     The purpose of this study is to determine if non-invasive electrical brain stimulation can~     enhance the outcome of intensive language therapy in chronic aphasia.~   "
125506|NCT01924689|"~     This protocol will examine the safety of intratumoral administration of Clostridium Novyi-NT~     spores in patients with treatment-refractory solid tumor malignancies. This investigational~     study will measure anti-tumor activity of C. novyi-NT administered intratumoral in patients~     with treatment-refractory solid tumor malignancies.~   "
125507|NCT01924676|"~     To estimate the effects of food on oxycodone pharmacokinetics after administration of 40 mg~     doses of PF-00345439 Formulation K and to estimate its relative bioavailability compared to~     PF-00345439 Formulation X in the fasted state in healthy volunteers~   "
125508|NCT01924663|"~     The purpose of this study is to be able to better describe the incidence, timing and severity~     of myocardial dysfunction and acute kidney injury (AKI) following a documented respiratory~     viral illness (RSV, adenovirus, metapneumovirus, parainfluenza, influenza, etc.) in pediatric~     patients.~   "
125509|NCT01924650|"~     The purpose of this study is to investigate the effects of varying particle size on the~     pharmacokinetics of PH-797804~   "
125510|NCT01924637|"~     This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetic~     (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the~     investigated drug on the body) properties of FIAsp (faster-acting insulin aspart) in subjects~     with type 1 diabetes.~   "
125512|NCT01924611|"~     AIM: To evaluate influence of two methods to avoid saliva contamination on the survival rate~     of atraumatic restorations in primary molars. 232 children, aged between 6-7 years, of both~     genders, were selected having one primary molar with a proximal dentine lesion. The children~     were randomly divided into two groups: a control group with class II ART restoration made~     using cotton rolls and an experimental group using rubber dam. The restorations were made and~     they were followed up every six months. After two years, the results were compilated and~     analyzed.~   "
125513|NCT01924598|"~     Anorexia Nervosa (AN) has the highest mortality of any psychiatric disorder and a paucity of~     effective treatments. AN becomes intractable in around 20%, resulting in huge individual and~     healthcare costs. Exploration of underlying processes and novel treatment strategies is thus~     crucial. This is a pilot study of a novel translational approach to the investigation and~     treatment of severe AN. The aims are (1) to explore the safety, acceptability and feasibility~     of Deep Brain Stimulation (DBS) for AN (2) to map neural mechanisms underpinning aberrant~     reward and optimise DBS targets. The study will involve 6 consenting adults with full mental~     capacity, and will last 15 months. It incorporates an ethical substudy including assessment~     of capacity and informed consent. It combines complementary forms of cutting edge~     neuroimaging including fMRI and MEG (magnetoencephalography). These will be complimentary in~     helping identify the best strategy for treating severe AN using DBS. Individuals with severe~     intractable AN will be eligible to take part. The study will be conducted in Oxford, United~     Kingdom at the John Radcliffe and Warneford Hospitals. The individuals will have preoperative~     ethical, neuroimaging and psychological assessments, A DBS operation in month 2, DBS switch~     on in month 3 month postoperatively . DBS will be targeted to the Nucleus accumbens, followed~     by a 12 month post switch on follow-up period with monthly joint neurosurgical psychiatric~     and psychological assessments and postoperative MEG scans . The study will further our~     understanding of food reward processes in general and AN in particular indeed promises to~     provide important information which may revolutionize future treatments. The proposal builds~     upon a body of research investigating the role of aberrant reward processes in AN and~     exploits our complementary research experience in AN using experimental behavioural~     strategies, fMRI , MEG and DBS to establish a powerful translational research strategy.~   "
125514|NCT01924585|"~     Surgery in persons of older AGE (SAGE) is an observational study of patients aged 60 years~     and older undergoing major colorectal surgery. That is to say we are looking at how older~     patients recovery following surgery, and that patients who volunteer to take part will~     absolutely not have any changes made to patients planned treatment or surgery.~      Patients (identified by their Consultant) will be asked if they would like to participate in~     the study, agreeing to undertake an additional questionnaire, blood test, provide a urine~     specimen and several basic physical tests during the pre-assessment visit taking an~     additional 30-45 minutes.~      This will not affect their treatment in any way. Participation is voluntary.~      At the time of the pre-assessment process the patient will then be approached by a~     researcher, who will explain the study in more detail and obtain written consent.~      The questionnaire is a combination of questions, which have been used in other similar~     studies and may be used to identify people who are fitter than others to undergo surgery.~     These questions are not too dissimilar to those that may be asked during the pre-assessment~     process. In fact some hospitals use some of these questions (but not usually all) routinely~     during a hospital admission process.~      Several basic physical tests will be performed: hand grip strength test and some basic~     walking and chair rising tests. These will be supervised by the trained researcher to ensure~     they are carried out safely.~      A small blood sample (20ml) will be obtained, ideally at the same time as blood is taken for~     the standard pre-operative assessment process. We will also take urine specimens. The blood~     sample and urine specimens will be saved for tests later. There are several potential blood~     and urine tests that may be related to physical frailty/impairment and the aging process.~      The patient will undergo surgery as planned and be discharged from hospital. No researcher~     will interfere with the planned care or conduct any data collection at this point.~      At approximately 1. 3, 6 and 12 months following surgery the patient will be asked to~     complete the questionnaire either in person, by phone or mail. If reviewed in a clinic at the~     time of their postoperative follow-up checks, then we will repeat the basic physical tests~     again also.~      The patient's notes will be reviewed by a researcher (who is also a doctor) to see what~     operation was performed, the length of hospital stay, and if any problems developed. The~     patients GP may also be contacted if additional information is required.~      This study, while based on several others, is the first of its kind to see how persons~     recover after surgery being assessed over one year.~      We will recruit for 18 months across two hospitals aiming to recruit 200 patients during this~     time.~   "
125515|NCT01924572|"~     The proposed study is a pilot prospective controlled trial to measure the blood volume left~     in the placenta after varying cord clamping times when the infant is placed skin-to-skin on~     the maternal abdomen. Delaying cord clamping has been shown to decrease anemia in infants.~     However, the best way to get the most blood to the baby is not known. The practice of cord~     clamping at birth is not the same among doctors and midwives and we do not know the effect of~     putting he baby on the mother's abdomen.~   "
125516|NCT01924559|"~     We will investigate the impact biohazard gear has on time to successful intubation and, in~     particular, determine how the Supraglottic Airway Laryngopharyngeal Tube (Ecolab, Columbus,~     Missouri) device compares to traditional direct laryngoscopy and fiber-optic (video)~     intubation techniques.~   "
125517|NCT01924546|"~     There is a large body of evidence from adult populations suggesting cognition in adults is~     affected by hydration status. The few studies conducted in the global North in populations of~     schoolchildren indicate that drinking water has an impact on pupil performance on basic~     cognitive tasks. No studies assessing the impact of dehydration and cognition in~     schoolchildren have been published in the global South, where access to water is the poorest~     and dehydration prevalence is likely higher. Our group previously carried out research on~     this topic in Mali, and will build upon findings from that work with this trial. This study~     will examine the effect of drinking supplementary water during the school day on hydration~     status and on cognitive test scores in schoolchildren in Zambia.~      The investigators hypothesize that providing supplemental water will result in a decrease in~     prevalence of dehydration in the study group and will result in an improved performance on~     cognitive test scores.~      Data will be collected from up to four purposively-selected schools in the region of Zambia~     where this study is taking place, from up to a total of 400 children. At each school pupils~     in grades 3-6 will be eligible for recruitment, dependent upon their understanding of~     research instructions. Research staff will explain the study to pupils at the school and~     individually request informed oral assent for participation. A waiver of parental consent for~     pupil interviews will be secured from the Ministry of Education. At each school, school~     directors will be asked to sign in loco parentis (in the place of parent) on behalf of the~     pupil participants.~      Children that assent to participate in the study will be randomly allocated to the~     intervention or control group. In the intervention group, study participants will receive~     supplementary water in the morning. In the control group, study participants will receive~     supplementary water in the afternoon. Testing procedures in both groups is identical and will~     include a five-minute interview, two cognitive testing sessions of 45 minutes each, and~     collection of two urine samples during the day. None of these activities collect personal~     data or identifiers, and the urine sample will not be stored.~      All data collection will occur at the school and will be conducted by trained local~     enumerators. There are no risks to participation other than a small amount of class time~     missed by pupils, and great efforts will be made to minimize time outside of class.~   "
125518|NCT01924533|"~     This study is a phase III, multi-centre study of olaparib in combination with paclitaxel,~     compared with placebo in combination with paclitaxel in patients with advanced gastric cancer~     who have progressed following first-line therapy. Patients will be from China, Japan , Korea~     and Taiwan.~   "
125519|NCT01924520|"~     A study was to evaluate the safety and plasma concentration changes of quetiapine after~     repeated administration of FK949E (extended-release formulation of quetiapine) in patients~     with major depressive disorder (MDD).~   "
125520|NCT01924507|"~     The investigators aimed to evaluated the role of bedside sleep medicine in an cardiology~     intensive care unit. The patients will be submitted to a overnight polysomnography. Those~     individuals with sleep apnea will be treated with CPAP during the ICU admission. Also, the~     investigators will identify the factors that compromise the sleep and will act to minimize~     them to improve the sleep quality.~      After the interventions, the investigators will evaluate if there are reduced days of~     hospital admission, major cardiovascular events (infarction, reinfarction, heart failure and~     stroke) and overall mortality.~   "
125521|NCT01924494|"~     Synchronous Tele-Endoscopy: A clinical feasibility study of gastrointestinal tele-endoscopy~     by implementing and evaluating synchronous tele-endoscopy using ENDOALPHA in a hospital based~     endoscopy unit. EndoAlpha will be used on the hospitals existing Intranet/LAN and the~     possibilities of tele-endoscopy on WAN through existing network, on separate dedicated line~     or through new established transmission lines, will be evaluated. The EndoAlpha system will~     be integrated in a highly advanced endoscopy procedure room. The system will integrate~     through LAN with doctor office, clinic conference and lecture room and GI pathologist room.~     Through either LAN or WAN, connection will be establish to a referral GI center in Denmark.~     Through WAN, connection will be established to doctor home and to an expert Spanish center.~   "
125522|NCT01924481|"~     The Hershey Company is interested in investigating the effects of various chocolate beverages~     on brain physiology and cognitive function. The main substances in the drinks that are known~     to influence the brain are caffeine (and related chemicals such as theobromine) and~     flavonoids. Flavonoids are chemical found in plants and are most commonly associated with~     antioxidant activity. Caffeine, chemicals related to caffeine, and flavonoids are all~     naturally occurring and all potentially alter brain physiology. This study will evaluate~     changes in brain blood flow and cognition following the consumption of drinks with various~     combinations of the Primary Ingredients. Caffeine is likely to have peak effects within~     1-hour of ingesting the chocolate while the flavonoids are likely to have peak effects 3-4~     hours after ingestion. The study proposed here will evaluate ingredients in a 4-arm~     cross-over double-blind design in an attempt to understand the differential effects of these~     compounds in chocolate drinks.~   "
125523|NCT01924468|"~     Background:~      - The risk for becoming addicted to drugs varies from person to person, even among those~     using similar drugs in a similar way. Researchers do not fully understand why some people~     become addicted to drugs and others do not. Studies suggest that under certain life~     circumstances, some genes may increase the risk for addiction. This study will use genetic~     information, computer tasks, magnetic resonance imaging (MRI), and other tests to see what~     brain networks may be related to drug addiction.~      Objectives:~      - To better understand brain networks that may be related to susceptibility to drug~     addiction.~      Eligibility:~      - Healthy non-smoking volunteers between 18 and 55 years of age.~      Design:~        -  This study will have one screening visit and four all-day study visits. For male~          participants, the visits will be about 7 days apart over 5 to 7 weeks. Female~          participants will have the visits scheduled to coordinate with their menstrual cycle.~        -  This study involves small doses of three approved drugs: two oral dopamine drugs and a~          nicotine patch. For each scanning session, participants will have three study drugs.~          However, only one pill or patch will be the real drug; the other two will be placebos.~          Some participants may have only placebos during a visit.~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be taken. Other tests will be given to ensure that participants are not~          smoking or using drugs while they are in the study.~        -  During the all-day scanning visits, participants will receive two pills and one patch in~          the morning and they will be trained on simple computer tasks. In the afternoon,~          participants will have MRI scans and we will measure their brain activity while they~          rest and while they perform computer tasks in the scanner. Participants will also answer~          questionnaires during the scanning visits.~   "
125524|NCT01924455|"~     Despite effective ART that can suppress both HIV and HBV, HBV-related liver disease remains a~     significant co-morbidity in this population. Little is known about the histologic spectrum of~     liver disease, the significance of complete vs. incomplete HBV suppression, the utility of~     novel virologic and serum markers of disease severity, and the long-term renal and bone~     effects of TDF-based therapy. This proposal will address these important questions and impact~     the science and health of those coinfected with HBV-HIV.~   "
125525|NCT01924442|"~     The Department of Veterans Affairs Randomized On/Off Bypass (ROOBY) Trial (CSP #517) was~     funded in 2001. ROOBY was designed to compare the short-term (30-day) and intermediate-term~     (1-year) outcomes for patients undergoing off-pump versus on-pump coronary artery bypass~     graft (CABG) procedures. The ROOBY trial reported a significantly higher 1-year adverse~     composite outcome rate (i.e., all-cause death, non-fatal myocardial infarction (MI) and/or~     repeat revascularization) for off-pump versus on-pump patients. ROOBY documented that a~     higher percentage of off-pump patients received fewer grafts than originally planned (i.e.,~     off-pump patients were less completely revascularized) as compared to on-pump patients.~     Across all anatomic regions of the heart, the 1-year graft patency rates were significantly~     lower for off-pump CABG patients. Based on these ROOBY trial initial findings, critically~     important clinical questions related to the long-term efficacy, stability and durability of~     the off-pump versus on-pump techniques have been raised. Extending the original ROOBY trial,~     this CSP #517 follow-up study (CSP 517-FS) will evaluate the longer-term impact of off-pump~     versus on-pump surgical approaches upon the future occurrence of major adverse cardiovascular~     events (MACE).~   "
125526|NCT01924429|"~     The purpose of this study is to determine the effects of Vyvanse, an FDA approved medication~     used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD), on brain activity~     in adults with attention-deficit hyperactivity disorder (ADHD). Participants may qualify for~     participation in this study because they have ADHD and are willing to participate in two~     Functional Magnetic Resonance Imaging (fMRI) scans and receive Vyvanse for treatment of their~     symptoms. Another purpose of this study is to collect and bank samples of blood for research~     to examine how genes influence brain activation seen during the brain scans. The study also~     seeks to find out whether certain genes are related to ADHD. Participants' entire genetic~     makeup will not be determined from this sample.~   "
125527|NCT01924416|"~     The primary specific aim is to test the hypothesis that use of a decision aid to enhance~     informed, shared decision making coupled with quality of life assessment in patients with~     advanced lung cancer receiving first-, second-, or third-line therapy will lead to a~     reduction in two major contributors of cost (number of chemotherapy cycles; number of~     advanced imaging studies) compared with the control arm.~   "
125528|NCT01924403|"~     This study will assess which of the three most common methods of wound closure in primary~     total knee arthroplasty (staples, interrupted vertical mattress, or running subcuticular~     suture) provide the best wound vascular perfusion. This can be achieve by using SPY~     intra-operative vascular angiography, which is commonly used in clinical practice to assess~     perfusion of wound closure at the clinic. By understanding the differences in perfusion~     afforded by different closure techniques, surgeons will then be able to select the technique~     that optimizes this parameter so as to avoid complications such as tissue necrosis, wound~     dehiscence, or infection.~   "
125546|NCT01924169|"~     The goal of this clinical research study is to learn if lenalidomide can increase the level~     of immunoglobulins (parts of the blood that may help to improve the immune system's function)~     and/or will improve the protective effect of the flu and pneumonia vaccines in patients with~     CLL.~   "
125529|NCT01924390|"~     This entire protocol involves procedures that are standard care. The purpose of the research~     is to evaluate whether there are any differences in new bone formation following tooth~     extraction and grafting of the extraction socket with either 100% mineralized FDBA (FDBA) or~     a combination of 70% mineralized & 30% demineralized FDBA (DFDBA). Both FDBA and DFDBA are~     commonly used in dentistry for this purpose. Until recently, there has been no human evidence~     of differences in new bone formation with one material versus another. Recently, DFDBA has~     been shown to provide a greater percentage of vital bone formation than FDBA. No studies have~     been done on materials that provide a combination of demineralized and mineralized FDBA for~     ridge preservation. That is the purpose of this study.~      There will be two subject groups in this study. All subjects will require extraction of at~     least one non-molar tooth, followed by replacement of the missing teeth with dental implants.~     Each group will have 22 subjects. The primary distinction between groups will be the use of~     either a combination of 70% mineralized & 30% demineralized FDBA or 100% mineralized FDBA:~     Group 1 will have 70% mineralized & 30% demineralized FDBA grafted into the extraction socket~     for ridge preservation. Group 2 will have 100% mineralized FDBA grafted into the extraction~     socket for ridge preservation. The allocation of subjects into group 1 or 2 will based on~     numbers drawn from a stack of sealed envelopes. A small flap will be reflected to an extent~     about 3-4mm beyond the bony walls of the socket. A measuring stent will be placed and~     measurements of ridge width and ridge height will be taken and recorded to the nearest 0.5mm.~     Ridge width will be measured using a ridge caliper at a point approximately 4mm apical to the~     facial and lingual bony crest. Ridge height will also be measured. The tooth will be~     extracted and the subject will then be randomized by drawing a sealed envelope from the~     stack. Either 100% mineralized FDBA or a combination of 70% mineralized & 30% demineralized~     FDBA will be placed in the socket to restore the ridge to appropriate contour. A dense~     polytetrafluoroethylene (PTFE) membrane will then be placed over the socket orifice extending~     about 3mm beyond the bony socket walls. A PTFE suture will be placed over the membrane to~     secure it in place. Primary closure will not be attempted. The patient will be seen 7-10 days~     after extraction/ridge preservation to assess healing. The subject will be seen again 21-28~     days to remove the PTFE membrane and to assess clinical healing.~      At the time of implant placement, the measuring stent and caliper will be used to determine~     the ridge width and ridge height again. The implant site will be prepared using a hollow~     trephine which allows retention of the bony core. The bone removed from the osteotomy site~     remaining in the trephine will be prepared for histologic examination and analyzed for new~     bone growth. The following histologic parameters will be measured: percent vital bone~     formation; percent residual graft material; and, percent nonmineralized connective~     tissue/bone marrow. Following initial preparation of the implant site with the trephine, an~     implant of the appropriate length and diameter will be placed. A healing abutment will then~     be placed. All subjects will be examined at 7-10 days following implant placement. The study~     will end at the time of this follow up visit. The patient will then be referred to his/her~     restorative dentist for final restoration.~   "
125530|NCT01924377|"~     Recent clinical studies have shown that atrial fibrillation (AF) in humans might be sustained~     by localized sources called mother rotors which exhibit persistent, fast, and well~     organized activity during AF and play an important role in the generation and maintenance of~     the fibrillatory activity. In this study, investigators aim to identify the~     electrophysiological characteristics of mother rotors during atrial fibrillation in patients~     with paroxysmal and persistent AF and to test whether ablation of such patient-specific~     substrates might improve the acute and long-term success of conventional catheter ablation~     therapy.~   "
125531|NCT01924364|"~     The overall purpose of this research is to evaluate the physical changes that occur over time~     after fat grafting for craniofacial trauma. This protocol is similar to an existing study~     (IRB# PRO0906101) presently conducted at the University of Pittsburgh by the same research~     team which utilizes fat grafts. The preparation of the fat graft material in each clinical~     trial is processed differently evaluating the effects of graft resorption after treatment.~   "
125532|NCT01924351|"~     Primary Objective:~      To determine if treatment with SRS followed by a HER-2 directed therapy regimen results in a~     6-month distant brain relapse rate of less than 30%.~      Secondary Objectives:~        1. Describe the natural history of neurocognitive function for women with brain metastases~          treated with SRS and HER-2 directed systemic therapy and establish a reference benchmark~          to generate hypothesis for future design of a phase III trial.~        2. Describe patterns of distant brain relapse after SRS for all patients and compare them~          between (a) patients with 1-3 vs. 4-10 brain metastasis and (b) between patients treated~          with each systemic therapy regimen~        3. Describe patterns of neurologic death~        4. Describe patterns of local brain relapse~        5. Describe patterns of re-irradiation with WBRT or SRS~        6. Describe adverse events~   "
125533|NCT01924338|"~     The study is intended to verify a newly developed method to measure the thickness of cranial~     soft tissue. In the study, a high-resolution MRI scan is used as ground truth for a laser~     scan of the forehead. The laser scan is acquired point by point with a prototype scanning~     unit developed at the University of Luebeck's Institute for Robotics.~      The measured tissue thickness using the near-infrared scanning approach is validated against~     the ground truth obtained by the MRI scan. The average accuracy of the reconstruction method~     is then computed over all subjects from the individual study arms.~      The required laser intensity and exposure time as well as the achieved measurement accuracy~     is evaluated with respect to the different skin types of the test subjects. Correlation~     between these features and the skin type according to the Fitzpatrick scale will be computed.~      For 1/3 of the subjects, the laser and MRI scans are repeated after 2 and 8 weeks. The~     results of the scans are compared and time dependency is analysed.~   "
125534|NCT01924325|"~     Nondisabling cerebrovascular events represent the largest group of cerebrovascular disease~     with a high risk of recurrent stroke. A recent trial indicated that clopidogrel and aspirin~     treatment reduced the risk of recurrent stroke and was not associated with increased~     hemorrhage events, compared with aspirin monotherapy. Apixaban, a new oral anticoagulant, is~     proved to be as effective as traditional anticoagulants with less risk of bleeding events.~      To estimate whether apixaban is beneficial for acute TIA or minor stroke, a randomized,~     double-blind, multicenter, controlled clinical trial has been designed. The investigators~     will assess the hypothesis that a 21-days apixaban regimen is superior to clopidogrel and~     aspirin dual-therapy for the treatment of high-risk patients with acute nondisabling~     cerebrovascular event.~   "
125535|NCT01924312|"~     Vascular risk factors may account for up to 80% of the memory and thinking problems~     experienced by our aging population today, by far in excess of that caused by Alzheimer's~     disease. By doing this study, we hope to learn how vascular risk factors cause memory and~     thinking changes in the elderly, and whether we can prevent memory and thinking changes by~     reducing these risk factors. Successful completion of project aims will allow an integrated~     understanding of mild cognitive impairment caused by vascular risks (MCI-CVD) with the~     potential for tremendous impact on one of the major healthcare crises facing the nation~     today.~      The study will enroll 80 participants with memory and thinking problems (mild cognitive~     impairment; MCI) and are at risk for stroke and further difficulties with memory and thinking~     that may eventually lead to disability and a diagnosis of dementia. Each participant will be~     randomized into one of two groups (40 in each group) and followed over 36 months. One group~     will be followed to allow us to understand the natural history of memory and thinking~     impairment, while the other group will receive intensive education and assistance with~     vascular risk factor (CVD) control.~   "
125561|NCT01923974|"~     A study investigating the analgesic effect of melatonin in a human heat injury model using~     quantitative sensory testing.~   "
145515|NCT01662492|"~     To evaluate the efficacy and safety of Botulinum Toxin Type A versus placebo (normal saline)~     as headache prophylaxis in adolescents (children 12 to 17) with chronic migraine.~   "
125536|NCT01924299|"~     The main purpose of this study is to look at the effect of ketoconazole and fluconazole on~     how much baricitinib gets into the blood stream. The study will also look at the tolerability~     of baricitinib and ketoconazole when given together and the tolerability of baricitinib and~     fluconazole when given together.~      Participants will be recruited into 1 of 2 treatment groups (Group A or Group B). Each~     treatment group will participate in 2 study periods. Participants will take baricitinib alone~     in 1 period and baricitinib with either ketoconazole or fluconazole in the other period. This~     study will last approximately 7 weeks.~   "
125537|NCT01924286|"~     Tuberculosis (TB) is the most common opportunistic infection amongst HIV-infected patients~     starting antiretroviral therapy (ART) in developing countries and thus the most frequent form~     of immune reconstitution inflammatory syndrome (IRIS). Paradoxical TB-IRIS occurs in 8- 43%~     of patients starting ART while on TB treatment and results in morbidity, hospitalisation,~     consumes health care resources and TB-IRIS may be fatal. We have previously demonstrated in a~     clinical trial that prednisone reduces morbidity when used for treatment of paradoxical~     TB-IRIS. This trial is a double-blind placebo-controlled trial of prophylactic prednisone~     (40mg/day for 2 weeks followed by 20mg/day for 2 weeks, started on the same day as ART) in~     patients with TB who are identified as being at high risk for paradoxical TB-IRIS (starting~     ART within 30 days of initiating TB treatment and CD4 < 100/μL). The trial will enroll 240~     participants, randomised 1:1 (prednisone:placebo). The primary endpoint is development of~     paradoxical TB-IRIS, defined using international consensus case definitions. Secondary~     endpoints include time to IRIS event, severity of IRIS, quality of life assessment, mortality~     and corticosteroids adverse events. The trial is powered to determine a reduction in TB-IRIS~     events.~   "
125538|NCT01924273|"~     Port wine stains Birthmark are congenital, progressive vascular malformations of the skin~     that occur in approximately 0.7% of newborns. Approximately 1.5 million individuals in the~     United States and 32 million people worldwide have Port wine stains birthmarks. Two-thirds of~     these malformations occur on the face. Personality development of virtually all patients is~     adversely affected as a result of the negative reaction of others to a marked person.~     Detailed studies have documented lower self-esteem and difficulties with interpersonal~     interactions in Port wine stains patients. Port wine stains are initially flat and red, but~     with time, they tend to darken to purple and become thickened as vascular nodules develop.~     This thickening occurs in approximately two-thirds of lesions and further disfigures the~     facial features of many patients.~   "
125539|NCT01924260|"~     This phase I trial studies the side effects and the best dose of alisertib when given~     together with gemcitabine hydrochloride in treating patients with solid tumors or pancreatic~     cancer that is metastatic or cannot be removed by surgery. Alisertib may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. Giving alisertib~     with gemcitabine hydrochloride may be an effective treatment for solid tumors or pancreatic~     cancer.~   "
125540|NCT01924247|"~     Background:~      Stroke represents one of the major health problems worldwide, particularly in transitional~     and industrialized countries. Stroke has a remarkable socioeconomic impact, especially in the~     ageing population, and therefore stroke prevention is important. Secondary preventive~     measures and rehabilitation are essential for reduction of recurrent events. However, to date~     appropriate secondary preventive programs for patients surviving a stroke with minor or no~     residual deficits have been poorly studied.~      Specific aims/projects:~      The aim of this study is to validate the effects of an outpatient secondary prevention~     program on vascular risk factors, adherence to vascular-protective medication, exercise~     capacity and health related quality of life.~      Working Hypothesis:~      The outpatient rehabilitation program results in a significant short (3 months) and long-term~     (1 year) improvement of vascular risk factors, neurological functions, exercise capacity,~     adherence to vasoprotective medication and health related quality of life.~      Experimental design/Methods:~      This is a prospective, randomized clinical trial. At least 100 patients will be randomized~     either to the interventional group or to a group which is treated only by the family~     physician. All patients will be assessed at baseline, at 3 months and 1 year. The primary~     outcome is the number of reached cardiovascular health goals (6 metrics) between the~     interventional group and the group which is treated only by the family physician.~      Expected value of the proposed project:~      The study has the potential to show that an outpatient rehabilitation program significantly~     improves vascular risk factors, adherence to medication, enhances quality of life and~     eventually reduces recurrent strokes and other vascular events. If this is confirmed,~     introducing outpatient rehabilitation programs will have a major socioeconomic impact.~   "
125541|NCT01924234|"~     The purpose of the study is to determine whether remifentanil influence the pharyngeal phase~     of swallowing using using pressure and impedance recordings. The purpose is also to compare~     remifentanil to morphine and younger to elderly volunteers.~   "
125542|NCT01924221|"~     Cardiac resynchronization therapy with pacemaker alone, or in combination with a~     cardioverter-defibrillator, prolongs life and decreases risk of heart failure exacerbation in~     patients with low ejection fraction and wide QRS. Some patients achieve decrease in QRS~     duration 6 months after cardiac resynchronization therapy. Such fenomenon is called reverse~     electrical remodeling of native conduction. Retrospective analysis showed that reverse~     electrical remodeling of the native conduction after at least 6 months of CRT is associated~     with decreased rate of ventricular arrhythmias and better survival. This study is designed to~     study reverse electrical remodeling prospectively.~   "
125543|NCT01924208|"~     Hypotheses~        1. Immunotherapy induces tolerogenic effects to allergens in T cell regulation in tonsils.~        2. Influenza vaccination induces a strong interferon response and decreases Th2 response in~          tonsils.~        3. Influenza vaccination as an adjuvant on immunotherapy induces a better response to~          immunotherapy.~   "
125544|NCT01924195|"~     Anlotibib (AL3818) is a kind of innovative medicines approved by State Food and Drug~     Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing~     Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with~     multi-targets, especially for VEGFR2、VEGFR3、PDGFRβ and c-Kit. It has the obvious resistance~     to new angiogenesis. The trial is to explore Anlotinib for the effectiveness and safety of~     andvanced non-small cell lung cancer who failed two lines of chemotherapy~   "
125545|NCT01924182|"~     This study compares two different ways to treat pain. The two ways are:~        1. continuing to take current pain medication(s) or~        2. receiving morphine, a pain medication from a drug pump (a system to deliver drug to your~          body) that is implanted.~      None of the procedures or products used in this study are experimental. The length the study~     will be about 25 weeks (between 5½ to 6½ months). The purpose of this study is to compare~     pain and opioid side effects between people who get a drug pump and people who do not get a~     drug pump that will stay on their current pain medication treatment.~   "
125547|NCT01924156|"~     The aim of this Phase I/II study is to evaluate the safety and efficacy of dendritic cells~     (DC) vaccine combined with cytokine-induced killer (CIK) cells in patients with renal cell~     carcinoma. Experimental recombinant adenovirus-transfected DC, which engineered to express~     MUC1 and Survivin are used for DC-based immunotherapy. Based on the results of our previously~     performed preclinical study with DC vaccine combined with CIK cells, the investigators plan~     to perform the clinical trial.~   "
125548|NCT01924143|"~     The purpose of the study is to evaluate the absorption, distribution, metabolism, and~     excretion (ADME) of a single oral dose of [14C]TD-9855~   "
125549|NCT01924130|"~     The purpose of this study is to develop and evaluate the effects of a school breakfast policy~     initiative (SBPI) on the incidence of overweight and obesity as well as breakfast patterns~     (both inside and outside of school) among 4th-6th grade children. The study integrates~     research, education and extension to promote healthy breakfast consumption among low-income~     children in urban schools and will leverage ongoing SNAP-Ed and the School Breakfast Program~     efforts.~   "
125550|NCT01924117|"~     Objective: Determine the genotypes and risk factors associated with human papilloma virus~     infection in Mexican women.~      Methods: It was a cross-sectional study of women attended at the Materno-Perinatal Hospital~     Mónica Pretelini and the Medical Research Center (CICMED), who were asked to complete a~     risk factor questionnaire and submitted to colposcopy to identify SIL. Cervical swab samples~     were obtained to perform linear array HPV genotyping test (Roche®, Mannheim, Germany).~   "
125551|NCT01924104|"~     The purpose of the study is to determine whether low-dose aspirin and low molecular weight~     heparin improve the implantation and pregnancy rates in patients with repeated implantation~     failures in IVF cycle.~   "
125552|NCT01924091|"~     To compare drug concentrations in vaginal fluid, genital tissue, and blood~   "
125553|NCT01924078|"~     The present study is to determine the adverse effects and clinical efficacy of AI combined~     with Capecitabine metronomic chemotherapy in postmenopausal breast cancer patients with~     Estrogen receptor and/or Progestrogen receptor positive.~   "
125554|NCT01924065|"~     Patients with atrial fibrillation undergoing cardioversion will be randomized to undergo~     transesophageal echocardiography or they will receive warfarin for 3 weeks with an~     international normalized ratio (INR) value between 2.0-3.0. Those who do not want to use~     warfarin will be given an approved new oral anticoagulant agent istead of warfarin for 3~     weeks.~      If thrombus is detected in left atrium or in left atrial appendage, no cardioversion will be~     performed. Other patients in the both groups will undergo electrical cardioversion. After the~     procedures all the patients will be given oral anticoagulant for at least 4 Weeks. All~     patients will have neurological examination and diffusion magnetic resonance imaging (MRI) at~     baseline and at postprocedural 7th day. Clinical and subclinical cerebral thromboembolic~     events detected by diffusion MRI will be recorded. Any bleeding events will also be recorded.~   "
125555|NCT01924052|"~     The investigators hypothesized that migraine without patients with many genetic loci~     associated with migraine (high genetic load) would be more sensitive and get provoked more~     migraine attacks by calcitonin gene-related peptide (CGRP) compared to patients with few~     genetic loci associated with migraine (low genetic load).~   "
125556|NCT01924039|"~     The investigators are proposing a project that will examine the effectiveness of brief~     motivational enhancement therapy in a population with concurrent psychotic disorders and~     substance use disorders. This study will represent an emerging line of inquiry, as best~     practice interventions with this concurrent disordered (CD) populations are yet to be~     established.~   "
125557|NCT01924026|"~     Phenylketonuria (PKU) is a genetic disorder known to cause severe reduction in intelligence~     and deficits in cognitive function; it is associated with an elevated level of Phenylalanine~     (Phe) in blood.~      Newborn screening and early treatment with restricted protein diet supplemented by a formula~     of amino-acids will preserve intelligence. In those with the severe form treated from birth,~     some deficits that affect higher functions of the brain are seen.~      Given this, there is disagreement about how milder forms of this disease should be managed~     and what level of Phe is safe to be left untreated.~      We seek to assess whether higher Phe levels, between 360 and 600µmol/L, are safe with respect~     to preservation of intelligence and higher cognitive functions.~   "
125558|NCT01924013|"~     The primary aims of this study are: 1) to determine whether maternal prenatal vitamin D3~     supplementation (4200 IU/week, 16,800 IU/week, or 28,000 IU/week) versus placebo increases or~     decreases infant length at 1 year of age, and 2) to determine whether maternal postpartum~     vitamin D3 supplementation (28,000 IU/week) versus placebo increases or decreases length at 1~     year of age among infants born to women who received vitamin D 28,000 U/week during~     pregnancy. Infants enrolled in the study will be followed for 2 years to document the~     persistence of any observed effects measured at 1 year of age. This study aims to enroll 1300~     pregnant women in the 2nd trimester at a maternity hospital in Dhaka. Participants will be~     randomized to one of three doses of vitamin D3 (4200 IU/week, 16,800 IU/week, or 28,000~     IU/week) or placebo throughout pregnancy. Women in the 28,000 IU/week group will be~     additionally randomized to either placebo or a continuation of 28,000 IU/week for 6 months~     postpartum. In addition to linear length, the trial will include analyses of inflammatory and~     hormonal determinants of infant growth, epigenetic phenomena that affect vitamin D~     metabolism, and diarrheal and respiratory morbidity in the infants.~   "
125559|NCT01924000|"~     The purpose of the study is to compare efficacy and safety of minoxidil 1% versus placebo in~     enhancement of eyebrows.~   "
125560|NCT01923987|"~     Radical treatment of primary rectal cancer with synchronous distant metastases includes~     surgical resection of primary and metastatic lesion. However, primary rectal cancer in case~     of metastasized disease are often locally advanced disease and need downsizing before~     surgery. It is reported that pelvic recurrence rates and distant metastasis rates outside~     liver are 30~35% and 60%, respectively. Therefore, combined treatment with radiotherapy and~     chemotherapy is used. However, the sequence of treatment modalities is not yet definitely~     established and preoperative chemoradiotherapy and surgical resection is accepted as an~     option of treatment. Conventional long course chemoradiotherapy delays administration of~     full-dose chemotherapy, and metastatic lesion can be progressed during chemoradiotherapy. In~     present study, we evaluate the efficacy of short course radiotherapy (SCRT) followed by~     full-dose chemotherapy with delayed surgical resection of the primary tumor and metastases.~   "
125562|NCT01923961|"~     An increase of the free fraction may allow a better removal of of protein-bound uremic toxins~     during dialysis. During predilution hemodiafiltration, the sodium chloride (NaCl)~     concentration will be increased in the infusion fluid at a target NaCl concentration and the~     effect on the removal of protein-bound toxins will be determined. Comparisons will be made to~     standard hemodialysis and hemodiafiltration.~   "
125563|NCT01923948|"~     Pregabalin 150mg or placebo are administered 1 hour preoperatively in patients undergoing~     partial hepatectomy. Postoperatively, patients receive morphine as rescue analgesic. Morphine~     consumption in the first 48 hours is documented. Postoperative pain is measured by the visual~     analogue scale (VAS) score.~   "
125564|NCT01923935|"~     The purpose of this study is to determine whether intravenous busulfan and melphalan as a~     conditioning regimen is effective in the treatment of multiple myeloma undergoing autologous~     stem cell transplantation.~   "
125565|NCT01923922|"~     High grade cerebral glioma is the most common primary brain tumor in adults and accounts for~     about 2.5% of all cancer deaths. Brain tumor affects approximately 2300 individuals per year~     in Canada. Noninvasive accurate and timely diagnosis is imperative.~      High grade glioma is an aggressive neoplasm with median survival of 12 months, irrespective~     of any treatment. The prognosis of these patients can only be decided based on pathology~     after biopsy or surgery. Conventional imaging techniques, such as routine magnetic resonance~     imaging(MRI), do not accurately predict the grade of malignancy of cerebral gliomas. Computed~     tomography(CT) perfusion allows us to study the blood supply to the tumor at the level of~     capillaries. This information permits determination of aggressiveness of cerebral gliomas at~     the time of diagnosis.~      In a preliminary study of 20 patients with high grade cerebral gliomas, we have shown that CT~     perfusion can predict survival at the time of diagnosis irrespective of the pathological~     grade and the treatment received. In the present study, we would like to extend our~     preliminary findings in larger group of patients to ensure that this technique is indeed~     robust. If our hypothesis was supported by our study, we will be able to subselect patients~     based on initial imaging for more aggressive treatment. In patients with shorter survival,~     the perfusion parameters may help in identifying new therapeutic targets (e.g.,~     anti-angiogenic agents) that may help in the treatment of these patients.~   "
125566|NCT01923909|"~     Aim: To study and compare the clinical effects of platelet-rich plasma (PRP) injections and~     intra-articular (IA) corticosteroid injections in patients with primary osteoarthritis (OA)~     of the knee. This study aims to demonstrate this by using the Oxford Knee Score and Western~     Ontario and McMaster Universities Arthritis Index (WOMAC) to illustrate quantifiable~     difference between the two treatment modalities. Patient satisfaction will be compared by~     utilizing the Short-Form Survey-12 (SF-12) Score. Our null hypothesis states that~     intra-articular PRP injections is more beneficial in the long-term treatment of primary OA of~     the knee.~   "
125567|NCT01923896|"~     The proposed study represents the first attempt to systematically investigate the use of DCS~     as an adjunct to behavioral intervention to address chronic food aversion through an~     randomized control drug trial in children treated at the Marcus Autism Center's Pediatrics~     Feeding Disorders Program. This pilot and feasibility study will involve a total of 16~     participants randomly assigned to experimental conditions: behavioral intervention or~     behavioral intervention + DCS (8 in each group). All participants will receive the same~     behavioral protocol involving three treatment sessions per day (45 minutes in length), for a~     total of 15 sessions across five consecutive days. In addition, participants in the~     behavioral intervention + DCS group will receive a low dose (0.7 mg/kg) of the drug using an~     acute dosing methodology, which has been demonstrated to produce a nearly negligible side~     effect profile with comparable treatment outcomes to chronic dosing. Timing of dosing will~     occur 1 hour prior to behavioral intervention, in line with prior clinical studies. Study~     staff, with consultation from a psychiatrist, will observe administration of DCS to~     participants by caregivers via their preferred method of formula consumption (bottle, cup, or~     tube) in liquid form. Participants will be evaluated during each treatment session and at~     follow-up using trained observers to collect data on mealtime behaviors, including~     acceptance, swallowing, disruption, expulsion, and grams consumed. This type of data~     collection is standard practice in the feeding disorders program. It is hypothesized that~     participants who receive DCS as an adjunct to behavioral intervention will show greater~     improvement in mealtime behaviors as reflected by these measures.~   "
125568|NCT01923883|"~     EUS-guided fine needle aspiration (EUS-FNA) is a safe and effective method for diagnosing~     pancreatic and peripancreatic solid masses. The aim of this study is to compare the two~     aspiration methods in EUS-FNA: negative-pressure suction with syringe vs. capillary sampling~     with stylet slow-pull technique. We will evaluate the diagnostic adequacy and accuracy of the~     specimens obtained by EUS-FNA with two aspiration methods.~   "
125569|NCT01923870|"~     -  To determine and compare the pharmacokinetics (PK) of a single dose of 25 mg Androxal in~          overweight male subjects with hepatic impairment and in volunteers with normal hepatic~          function.~        -  To compare the safety profile of a single dose of 25 mg Androxal in overweight male~          subjects with hepatic impairment and in volunteers with normal hepatic function.~   "
125570|NCT01923857|"~     -  To determine and compare the pharmacokinetics (PK) of a single dose of 25 mg Androxal in~          overweight male subjects with various stages of renal impairment and in volunteers with~          normal renal function.~        -  To compare the safety profile of a single dose of 25 mg Androxal in overweight male~          subjects with various stages of renal impairment and in volunteers with normal renal~          function.~   "
125571|NCT01923844|"~     Exogenous bolus surfactant administration may affect hemodynamic parameters and peripheral~     perfusion. Surfactant therapy is commonly used for respiratory distress syndrome in premature~     infants, which is also associated with inflammation. There are different types and doses of~     surfactant preparations available. With the help of new generation monitors, changes in~     peripheral perfusion and transcutaneous CO, a marker of inflammation, may be demonstrated.~   "
125572|NCT01923831|"~     The purpose of this study is to compare the effect of magnesium sulfate and dexamethasone on~     postoperative sore throat after spinal surgery in prone position with tracheal intubation.~   "
125596|NCT01923506|"~     This phase I trial studies the side effects and best dose of stereotactic body radiation~     therapy in treating patients with prostate cancer after undergoing surgery. Stereotactic body~     radiation therapy may be able to send x-rays directly to the tumor and cause less damage to~     normal tissue.~   "
125573|NCT01923818|"~     Transient ischemic attack (TIA) or minor ischemic stroke has a high risk of early recurrent~     stroke. As the golden standard, aspirin effect modestly on acute ischemic stroke, and~     slightly increase the risk of intracerebral hemorrhage. Recently, rivaroxaban, a new oral~     anticoagulant, is proved to be as effective as traditional anticoagulants, while carrying~     significantly less risk of intracranial hemorrhage.~      The TRACE trial is a randomized, double-blind, multicenter, controlled clinical trial in~     China. The investigators will assess the hypothesis that a 30-days rivaroxaban regimen is~     superior to aspirin alone for the treatment of high-risk patients with acute nondisabling~     cerebrovascular event.~   "
125574|NCT01923805|"~     This prospective study will evaluate the effectiveness of Vitagel (VG) in reducing blood loss~     associated with Revision Total Knee Arthroplasty (RTKA) procedures by assessing the patient's~     change in hemoglobin/hematocrit. Transfusion rates with the use of VG compared to the current~     standard of care will also be evaluated. The effectiveness of VG to potentially reduce pain,~     and increase return to function and quality of life will be assessed through the modified~     Knee Injury and Osteoarthritis Outcome Score (Modified KOOS), the Numerical Assessment Pain~     Scale (NAPS), and the SF-12 health survey. Analgesic use will be recorded post-operatively.~   "
125575|NCT01923792|"~     House Dust Mites (HDM) are arachnids that infest bedding, carpet, upholstered furniture and~     fabric. Like many other allergens, exposure to HDM allergens in sensitised patients is~     associated with poorer lung function, greater medication requirements and more asthma~     symptoms as well as chronic rhinosinusitis symptoms. In contrast to other allergens, there is~     evidence that HDMA leads to the development of asthma, in addition to exacerbating~     pre-existing asthma in HDM-sensitised patients.~      ToleroMune HDM is currently being developed for the treatment of HDM allergy.~      The Purpose of this optional observational follow-on study is to evaluate the continued~     efficacy of TM-HDM in HDM allergic subjects based on change in TRSS from TH002 baseline~     approximately two years after the completion of the baseline EEC visit in TH002 following~     challenge with HDM allergen in an EEC.~   "
125576|NCT01923779|"~     Grass pollen allergens are recognised as a major cause of allergic diseases in humans and~     animals. Worldwide, at least 40% of allergic patients are sensitised to grass pollen~     allergens and between 50-90% of hayfever or seasonal allergy sufferers are allergic to grass~     pollen. ToleroMune Grass is a novel, synthetic, allergen-derived peptide desensitising~     vaccine, currently being developed for the treatment of grass allergy.~      The purpose of this optional observational follow-on study is to further evaluate~     rhinoconjunctivitis symptoms on exposure to Grass in the EEU among subjects who completed all~     dosing visits in study TG002 approximately one year after the start of treatment.~   "
125577|NCT01923766|"~     In this study, investigators are trying to see if infusion of m-CTLs will prevent or treat~     cytomegalovirus (CMV), Epstein Barr Virus (EBV) and adenovirus (AdV) reactivation or~     infection after cord blood transplant.~      Patients with blood cell cancer, other blood disease or a genetic disease may receive a cord~     blood transplant (UCBT) from an unrelated donor. After receiving a cord blood transplant,~     they are at risk of infections until a new immune system to fight infections grows from the~     cord blood cells. In this study, investigators are trying to give special cells from the cord~     blood called T cells. These cells will try to fight viruses that can cause infection.~      Investigators will test to see if blood cells from donor that have been grown in a special~     way, can prevent patients from getting an infection. EBV, AdV and CMV are viruses that can~     cause serious life-threatening infections in patients who have weak immune systems after~     transplant.~      T lymphocytes can kill viral cells but normally there are not enough of them to kill all the~     virus infected cells after transplant. Some researcher have taken T cells from a person's~     blood, grown more of them in the laboratory and then given them back to the person during a~     viral infection after a bone marrow transplant. Some of these studies have shown a positive~     therapeutic effect in patients receiving the CTLs (specially trained T cells) after a viral~     infection in the post-transplant period. In this study we are trying to prevent or treat~     viral infections by given the CTLs soon after getting the umbilical cord blood transplant.~      With this study, investigators want to see if they can use a kind of white blood cell called~     T cells to prevent or treat AdV, EBV and CMV infection. Investigators will grow these T cells~     from the cord blood before transplant. These cells have been trained to attack~     adenovirus/EBV/CMV- infected cells and are called multivirus-specific cytotoxic (killer)~     T-cells or m-CTL. Investigators would plan to give patients one dose of m-CTL any time from~     30 to 364 days after your transplant. They have used T cells made in this way from the blood~     of donors to prevent infections in patients who are getting a bone marrow or blood stem cell~     transplant but this will be the first time investigators make them from cord blood.~   "
125578|NCT01923753|"~     This is a double-blind randomised controlled crossover study to investigate whether high~     frequency airflow oscillation (HFAO), delivered using Aerosure, improves sputum clearance in~     patients admitted to hospital with infective exacerbations of cystic fibrosis (CF). This~     study will test the hypothesis that the wet weight of sputum expectorated is greater~     following the use of Aerosure than following the use of a sham Aerosure device.~   "
125579|NCT01923740|"~     To evaluate the safety and efficacy of the Absorb BVS System compared to the XIENCE V~     Everolimus Eluting Coronary Stent System (EECSS) in the treatment of subjects with ischemic~     heart disease caused by up to two de novo native coronary artery lesions in separate~     epicardial vessels.~   "
125580|NCT01923727|"~     This is a Phase I/IIa study evaluating the safety and feasibility of [89Zr]Df-IAB2M as an~     immunoPET tracer for metastatic prostate cancer. Individuals participating in this study will~     have a FDG PET scan, as well as four (4) PET scans (over a 3 day period) following the~     injection of [89Zr]Df-IAB2M PET tracer. Three different dosing levels will be explored. The~     purpose of the study is to demonstrate the safety of [89Zr]Df-IAB2M, ability to detect~     prostate cancer, and optimal time point and dose level for imaging.~   "
125581|NCT01923714|"~     This study aims at validating in real-life clinical practice and using the self-reported~     Glaucoma Symptom Scale (GSS) questionnaire, the impact of a switch to preservative-free~     dorzolamide/timolol fixed combination (DTFC) in patients using preserved topical therapy for~     glaucoma.~   "
125582|NCT01923701|"~     The main objective of this study is to decrease the severity of symptoms and improve~     psycho-social functioning in youth at high risk of developing psychosis by providing a~     specialized Group-and-Family-based Cognitive Behavioral Therapy (GF-CBT).~   "
125583|NCT01923688|"~     The purpose of the project is to improve in-patient safety by lowering the risk of severe~     hypoglycemia (low blood sugar) for patients with diabetes on insulin therapy and to improve~     communication between healthcare providers.~      The procedures of the study are:~        -  the hospital patient information system [Pharmacy Event System,(PES)] will generate for~          healthcare providers a real-time risk alert of severe hypoglycemia (low blood sugar)~        -  the real-time PES risk alert will be sent via a beeper to the patient's charge nurse~        -  the charge nurse will follow the specific guidelines in the alert for assessment of the~          patient's care and insulin regimen~        -  the charge nurse will then notify the physician of the patient's assessment and of the~          recommendation for change/no change in insulin regimen and/or clinical care~        -  the alerted charge nurse and physician will complete a collaboration scale~   "
125584|NCT01923675|"~     1. To determine the effect of spectacles with a red blocking filter on myopia progression~          in children.~        2. To determine the effect of spectacles with a holographic diffuser that spreads incident~          light rays over an angle of 0.5 degrees on myopia progression in children~        3. To determine the combined effects of spectacles with a red blocking filter and a~          diffuser that spreads incident light over an angle of 0.5 degrees on myopia progression~          in children.~   "
125585|NCT01923662|"~     The purpose of this study is to improve the performance of neuroprosthesis for standing after~     SCI by developing and testing new advanced methods that use multiple contact peripheral nerve~     electrodes to slow the onset of fatigue and increase standing duration. The new advanced~     methods will take advantage of the ability of multiple-contact nerve cuff electrodes to~     selectively activate portions of a muscle that perform the same action. Alternating~     activation to multiple muscles (or parts of the same muscle) rather than continuously~     activation the entire muscle group constantly should allow them to rest and recover from~     fatiguing contractions. This should allow users to remain upright for longer periods of time~     to perform activities of daily living, reduce the risk of falls due to fatigue, and increase~     the potential of receiving the health benefits of standing.~   "
125586|NCT01923649|"~     The purpose of this study is to assess if Somatuline autogel 90 mg is effective in the~     treatment of dumping syndrome.~   "
125587|NCT01923636|"~     The main objective of this study is to elaborate, in the neonatal period, a prognostic score~     for the development of neurological and sensorineural sequelae at 1 year in neonates infected~     in utero by cytomegalovirus. This score will be based on clinical, imaging and biological~     evaluations.~      The second objective of the study is to estimate the prevalence of this infection in France~     and to describe its epidemiology through the screening of 10,000 consecutive neonates.~   "
125588|NCT01923623|"~     This clinical, randomized, and controlled study will provide valuable scientific evidence~     regarding the effect of adding peripheral nerve blockades to general anaesthesia during ankle~     surgery. In particular, the investigators want to determine if the need for postoperative~     opioids will be reduced and whether this will lead to shorter admission to recovery room and~     fewer instances of side effects such as postoperative nausea and vomiting. In addition, the~     investigators will determine whether the functional outcome is improved i.e. faster and more~     successful rehabilitation. This would have profound benefits not only to the individual~     patient but also to society by reducing expenses during admission, the cost of sick leave~     etc.~   "
125589|NCT01923610|"~     24 healthy male and female volunteers who are at low risk of HIV infection and entered into~     the RISVAC02 study and were randomly allocated to receive 3 intramuscular injections of MVA-B~     at weeks 0, 4 and 16 will receive a boosting dose 4 years thereafter.~      Participants will attend one of two clinical centres on at least 5 occasions over 16 weeks.~     These visits will comprise:~        -  Screening~        -  Trial entry and boosting immunisation~        -  Early follow-up after immunisation~        -  Follow-up x 2 including the final visit Participants will have blood and urine~          collected, and receive 1 immunisation. They will be counselled prior to and following a~          HIV test, and given health education on prevention of sexually transmitted infections~          including HIV. T~      The two centres which participate are:~        -  Hospital Clinic, Barcelona and~        -  Hospital Gregorio Marañón, Madrid The primary objective is to explore the safety and~          immunogenicity of MVA-B.~   "
125590|NCT01923597|"~     The purpose of this study is to determine the safety and effect of green tea~     (epigallocatechin gallate) in albuminuria in diabetic patients and nephropathy.~   "
125591|NCT01923584|"~     The purpose of this study is to evaluate the effects of EPI-743 in patients with Parkinson's~     disease.~   "
125592|NCT01923571|"~     Intraoperative blood glucose concentration abnormalities are associated with increased~     perioperative morbidity and mortality (1-4). Severe intraoperative hyperglycemia (BGC ≥ 200~     mg/dl) in patients undergoing craniotomy for urgent/emergent craniotomy after traumatic brain~     injury complicates 15% of the cases and is associated with higher in-hospital mortality.~     Intraoperative use of dexamethasone during craniotomy is also known to induce an increase in~     blood glucose concentration.~      The importance of blood glucose concentration in neurosurgical patients is witnessed by the~     effects of tight blood glucose control on incidence of infections and neurological outcome .~     Currently available evidence suggest that, in neurosurgical patients, perioperative BGC~     values should be within the 80-180 mg/dl range .~      Data on the prevalence of severe intraoperative hyper (blood glucose concentration >180~     mg/dl) and hypoglycemia (blood glucose concentration <80 mg/dl) in patients undergoing~     craniotomy for supra or infratentorial surgery as elective or emergency procedure are lacking~     as it is not known whether in these patients intraoperative severe hyperglycemia relates to~     an increased incidence of postoperative infections is unknown.~      Aim of this prospective observational study -in patients undergoing craniotomy for supra or~     infratentorial surgery as elective or emergency procedure- was to test the hypothesis that~     severe intraoperative hyperglycemia (blood glucose concentration ≥180mg/dl) is associated~     with an increased incidence of infections within the first postoperative week (pneumonia,~     sepsis, urinary and wound and cerebral infections). We also recorded the prevalence of severe~     intraoperative hyper and hypoglycemia (blood glucose concentration<80 mg/dl) in recruited~     patients.~   "
125593|NCT01923558|"~     To evaluate and compare the relative bioavailability and therefore the bioequivalence of two~     different formulations of donepezil after a single oral dose administration under fasting~     conditions.~   "
125594|NCT01923545|"~     This study is to examine which dose of DA-3031(PEG-G-CSF) has similar efficacy and safety~     compared to daily G-CSF in chemotherapy-induced neutropenia.~   "
125595|NCT01923519|"~     The respiratory epithelium plays a leading role in the development of allergic respiratory~     disease with barrier function alteration, its repair mechanisms, of anti-viral fight and the~     ability to induce by itself Th2 responses. The majority of allergic asthmatic patients have~     reached concomitant ENT: the concept of one airway, one disease. Access to this material of~     epithelial study in the different phenotypes of the disease appears to be crucial. Nasal and~     bronchial epithelial tissues reveal essential differences in particular related to their~     environment (remodeling less intense and a lower sensitivity to the virus in the nose), but~     they nevertheless share many common cellular characteristics.~   "
125599|NCT01923467|"~     This project is designed to test the effects of affirmation and positive/negative imagery on~     individuals' thoughts about quitting smoking and willingness to join a stop smoking program.~     Previous studies have noted that viewing negative images elicits a stronger emotional~     response, and many stop-smoking campaigns have used such images to push people to quit~     smoking. However, research also shows that people are generally resistant to health messages.~     Using affirmation can help to lessen that resistance.~      In this study, we use a 2x3 design to study the individual effects of negative imagery and~     affirmation on smokers' intentions to quit smoking, acceptance of an offer to join a quit~     smoking program, and program participation and outcomes. We hope to find out whether there is~     an additive effect of the negative imagery and affirmation on the outcomes listed above. Our~     specific aims are:~      Aim 1: Determine if affirmation increases the uptake of an offer of joining a stop smoking~     program.~      Aim 2: Determine if image type (positive vs. neutral vs. negative) increases the uptake of~     the stop smoking program offer.~      Aim 3: Determine whether there is an interaction between image type and affirmation in~     people's willingness to join a stop smoking program.~   "
125600|NCT01923454|"~     This study was to evaluate the efficacy and safety of immediate anterior chamber paracentesis~     (ACP) with a 30-gauge needle as an initial treatment for acute primary angle closure (APAC).~   "
125601|NCT01923441|"~     Currently, there is no direct, reliable, bed-side, and non-invasive method for assessing~     changes in brain activity associated with concussion. Event Related Potentials (ERPs), which~     are temporal reflections of the neural mass electrical activity of cells in specific regions~     of the brain that occur in response to stimuli, may offer such a method, as they provide both~     a noninvasive and portable measure of brain function. The ERPs provide excellent temporal~     information, but spatial resolution for ERPs has traditionally been limited. However, by~     using high-density electroencephalograph (EEG) recording spatial resolution for ERPs is~     improved significantly. The paradigm for the current study will combine neurophysiological~     knowledge with mathematical signal processing and pattern recognition methods (BNA™) to~     temporally and spatially map brain function, connectivity and synchronization.~      The proposed study will provide additional evidence for the utility and contribution of the~     BNA™ test (reflecting temporal and spatial changes in brain activity as well as brain~     functional connectivity associated with concussion) in concussion management.~   "
125602|NCT01923428|"~     This phase 2, randomized, double blind, placebo-controlled, multi-center study will evaluate~     the safety and efficacy of three dose levels of AZD1722 in subjects with constipation~     predominant IBS (IBS-C) as defined by the ROME III criteria and who have active disease as~     determined during a two-week screening period. Subjects who qualify and are randomized into~     the study will receive 5, 20, or 50 mg of AZD1722 BID or placebo BID for 12 consecutive~     weeks. At the end of this treatment period, subjects will be followed for an additional 4~     weeks.~   "
125603|NCT01923415|"~     The purpose of this study is to characterize the clinical and molecular profiles of patients~     with cutaneous lupus.~   "
125604|NCT01923402|"~     This study was conducted to develop biomarkers of tobacco effect that would indicate~     potential harm related to tobacco consumption. To gain a better understanding of chronic~     effects of tobacco consumption, this cross-sectional clinical study enrolled generally~     healthy, adult male consumers of cigarettes (SMK), moist snuff (MSC), and no tobacco products~     (NTC).~   "
125605|NCT01923389|"~     This is a trial in obese subjects to study the safety, tolerability, pharmacokinetics and~     pharmacodynamics of multiple doses of PF-05231023.~   "
125606|NCT01923376|"~     The purpose of this study is to evaluate whether the use of polyethylene glycol is superior~     and more safe in treating hepatic encephalopathy compared to lactulose and also to determine~     if treatment with polyethylene glycol will reduce the duration of hospital stay.~   "
125607|NCT01923363|"~     Worldwide rates of obesity have doubled in the last 30 years, and obesity has been associated~     as a risk factor for hospital-acquired infections and increased occurrence of death in~     critically-ill patients. Piperacillin/tazobactam is a commonly prescribed antibiotic for~     critically ill patients with an infection, however, limited information exists for dosing~     this drug in obese patients. In these limited reports, standard doses of~     piperacillin/tazobactam given to the small number of obese patients resulted in lower blood~     concentrations, which could lead to inadequate killing of bacteria. The purpose of this study~     is to compare blood concentrations from standard piperacillin/tazobactam dosing compared to~     higher dosing regimens in obese patients. This study will also include information on the~     safety and tolerability of the higher dose regimens. The study investigators believe that the~     higher dosing regimen will produce adequate blood levels in obese patients and will not add~     any more risk of harm to obese patients receiving this higher dose.~   "
125608|NCT01923350|"~     The Avoiding Diabetes After Pregnancy Trial (ADAPT) study was designed to test the~     effectiveness of interventions that potentially increase the adoption of Diabetes Prevention~     Program (DPP) elements by women who had a pregnancy with gestational diabetes mellitus (GDM).~      The study was conducted as an integrated trial with two separate arms: one to facilitate~     weight reduction and the other to increase diabetes testing.~      There were two hypotheses:~        1. Women in the testing intervention will be more likely to have received a diabetes test~          within the 6 months post-intervention than women in the control group.~        2. Women in the weight reduction intervention will have lost more weight at the 6-month and~          9-month follow-up than women in the control group.~      The primary study aim was to determine the efficacy of a system of interactive~     technology-based supports to prompt women with a history of gestational diabetes to take~     steps to prevent diabetes. The secondary aims were focused on women's engagement:~        -  To evaluate the impact of the weight reduction intervention in terms of participant~          engagement with the interactive technology-based supports.~        -  To evaluate changes in the women's perception of their personal diabetes risk following~          after exposure to information about diabetes risk following a pregnancy with GDM.~        -  To identify the determinants and motivators of and barriers to diabetes testing in the~          6- to 12-week postpartum period and thereafter, using the Health Belief model to guide~          the study.~      There was an additional secondary aim involving metformin:~        -  To evaluate the impact of the diabetes risk reduction intervention in terms of women~          seeking out their physician's advice on metformin treatment and receiving a metformin~          prescription, if appropriate.~   "
125611|NCT01923311|"~     This study will evaluate the steady-state pharmacokinetics (PK) and confirm the dose of~     ritonavir (RTV)-boosted elvitegravir (EVG/r). This study will also evaluate the safety,~     tolerability, and antiviral activity of elvitegravir (EVG) administered with a background~     regimen containing a ritonavir-boosted protease inhibitor (PI/r) in HIV-1 infected,~     antiretroviral (ARV) treatment-experienced pediatric participants.~      The study consists of 2 parts: Part A and Part B. Part A will enroll participants with~     suppressed viremia (HIV-1 RNA < 50 copies/mL) or failing a current ARV regimen (HIV-1 RNA >~     1,000 copies/mL) to evaluate the steady state PK and confirm the dose of EVG. Part B will~     enroll participants who are failing a current ARV regimen (HIV-1 RNA > 1,000 copies/mL) to~     evaluate the safety, tolerability, and antiviral activity of EVG.~   "
125612|NCT01923298|"~     Estrogen receptor positive breast cancer is the most common type of breast cancer and~     anti-estrogen therapy has been shown to be very effective in preventing recurrence. Side~     effects of anti-estrogens are due to estrogen deprivation and include hot flashes, mood~     changes and vaginal dryness/pain. Vaginal symptoms including pain, dryness, itching, bleeding~     after intercourse and frequent urinary tract infections have been reported to cause~     significant morbidity in postmenopausal women and higher in breast cancer survivors on~     anti-estrogen therapy. Treatment options include vaginal lubricants, Replens etc but~     unfortunately many women continue to have persistent symptoms. Local estrogen has been shown~     to be effective in post menopausal women (Estring or Vagifem) for their vaginal symptoms.~     There is a concern of using this in women with breast cancer given it may increase their~     blood estrogen levels. Studies done so far show have shown controversial results but majority~     of them report that blood estrogen levels do not change significantly. The major drawback of~     the studies was the sample size and inadequate accrual. The most recent trial reported showed~     no significant change in blood estrogen levels in women with breast cancer treated with~     aromatase inhibitors (anti-estrogen therapy) and were on vagifem for their vaginal symptoms.~     The authors reported results in 26 patients and reported no significant change in blood~     estrogen level. We propose to study the change in blood estrogen level when postmenopausal~     women with breast cancer who are currently on aromatase inhibitors are treated with Estring~     for their vaginal symptoms.~   "
125613|NCT01923285|"~     The purpose of this study is to evaluate the safety and effectiveness of the AXIUM~     Neurostimulator System for the treatment of chronic lower limb pain in persons diagnosed with~     Complex Regional Pain Syndrome (CRPS) or Peripheral Causalgia (PC).~   "
125614|NCT01923272|"~     The purpose of this multi-center, prospective, double-blind, randomized, sham-controlled~     pilot study is to study feasibility and collect additional preliminary clinical data related~     to the safety and clinical benefits of non-invasive vagal nerve stimulation with the~     AlphaCore device for the treatment and prevention of exercise-induced bronchoconstriction,~     and to support the development and approval of a larger pivotal study.~      The objectives of this study are (1) to gather preliminary safety and efficacy data of the~     AlphaCore device for the treatment of EIB (Treatment Visit 1) and prevention of EIB~     (Treatment Visit 2), (2) to validate the sham device (blinding effects, placebo effect) as an~     effective control for use in future clinical studies, and (3) to support the development and~     approval of a pivotal study, confirm data collection methods and endpoint definitions, and~     confirm appropriateness of the subject follow up plan.~   "
125615|NCT01923259|"~     To evaluate and compare the relative bioavailability and therefore the bioequivalence of two~     different formulations of donepezil after a single oral dose administration under fed~     conditions.~   "
125616|NCT01923246|"~     The primary aim of the present study is to study the effect of a brief automated alcohol~     intervention in University students, and if there is a difference in effect between automated~     brief interventions delivered by internet (WEB) or Interactive Voice Response (IVR), and to~     study if there is difference in effect between single and repeated interventions.~   "
125617|NCT01923233|"~     This study is an individualized anti-cancer vaccine protocol where the vaccination occurs~     inside of the body. To create the vaccine, a tumor lesion is selected and caused to die by a~     process called Radiofrequency Ablation or RFA. RFA causes the tumor to release its internal~     contents to the surrounding environment, such contents include tumor-specific antigens.~     Immune cells respond to the tissue damage and take-up these tumor antigens. The injection of~     the experimental cell drug, AlloStim(TM) into the lesion is designed to cause the responding~     cells to signal the immune system of the danger of the tumor, creating tumor-specific~     immunity.~   "
125618|NCT01923220|"~     This is a single-center, open-label, randomized, prospective study evaluating the safety and~     efficacy of HO/02/02 20µg topically applied daily for 15 minutes (with gauze) on treatment~     fields vs. standard of care (SoC), Aloe Vera treatment~   "
125619|NCT01923207|"~     The purpose of this study is to assess the safety and tolerability of the study drug~     (DX-2930) administered subcutaneously in healthy subjects. Subjects will be randomized to~     receive DX-2930 or placebo.~   "
125620|NCT01923194|"~     Evaluate the Efficacy and Safety of Highly Purified Urofollitropin for Injection Compared to~     Recombinant Human Follitropin Alfa for Injection for Ovulation Induction in Chinese females~   "
125621|NCT01923181|"~     This trial is conducted globally. The aim of the trial is to examine the dose range,~     escalation and efficacy of oral semaglutide in subjects with type 2 diabetes.~   "
125622|NCT01923168|"~     The purpose of the study is to determine whether treatment with a PI3K inhibitor plus~     letrozole leads to an increase in pathologic clinical response and Objective Response Rate~     compared to treatment with placebo plus letrozole in patients with Breast cancer~   "
125623|NCT01923155|"~     There is no theoretical or practical reason why non-medical personnel such as nurses could~     not be trained to perform diagnostic colonoscopy with comparable proficiency as medical~     endoscopists. Nurse endoscopists have been widely accepted in the United Kingdom for the past~     15 years as a valuable resource to cope with the increasing demand for endoscopic service, in~     particular diagnostic colonoscopy for colorectal screening. A pilot study performed in Hong~     Kong in 2008 has shown that endoscopy nurses can be trained to perform diagnostic endoscopy~     safely and reliably. This study aims to demonstrate that properly trained nurse endoscopists~     have a comparable proficiency in performing colonoscopy procedures as their medical~     counterparts.~   "
146573|NCT01648517|"~     This is a prospective phase II trial, in patients with unresectable or metastatic NSCLC using~     chemotherapy regimens which will be defined according to the mRNA expression of ERCC1 and~     RRM1 of the tumor cells.~   "
125624|NCT01923142|"~     The purpose of this study is to evaluate the hypothesis that, in patients with stable~     vitiligo unresponsive to conventional treatments including traditional phototherapy and/or~     topical steroids, the application of a non-cultured autologous hair follicle~     outer-root-sheath melanocytes suspension in the area affected by the disease followed by~     targeted ultraviolet B (UVB) phototherapy can lead to a significant skin repigmentation. To~     assess the effect of the proposed treatment, a within-subject controlled study involving~     selected symmetric lesion areas localized to the back of the hands will be conducted.~   "
125625|NCT01923129|"~     There is no general agreement about the optimal duration of postoperative urinary drainage,~     with relevant literature reporting durations ranging from 1 to 10 days. The available~     research supporting the routine use of prolonged catheterization is limited and studies~     investigating early removal following infraperitoneal colorectal surgery have largely been~     underpowered to form valid practice conclusions. The aim of the investigators study is to~     determine whether a postoperative colorectal patient can safely have an indwelling catheter~     removed on postoperative day one (24 hours following surgery) with the addition of a study~     medication (prazosin), without a statistically significant difference in the incidence of~     urinary retention compared to the standard, accepted approach of delayed removal (72 hours~     postoperatively). Patients undergoing laparoscopic and open pelvic colorectal surgery below~     the peritoneal reflection for both benign and malignant conditions will be randomized into~     two groups: group one will have the catheter removed on postoperative day 3 (72 hours~     postoperatively) Group 2 will have a dose of the alpha-blocker prazosin given 6 hours prior~     to catheter removal and will have the urinary catheter removed on postoperative day 1 (24~     hours postoperatively).~   "
125626|NCT01923116|"~     The objective of the study is to assess, in a phase 1/2 study, the safety and efficacy of~     this synthetic vaccine SLP-HPV-01® in HIV+ men with CD4 counts > 350 x 10E6/l and~     HPV16-induced intra-anal high-grade AIN (grade 2-3) that failed on, or recurred after~     previous treatment.~   "
125627|NCT01923103|"~     Dupuytren disease (DD) is a progressive fibromatosis of the palmar fascias of the hand and~     fingers, which may lead to extension deficits of the fingers. The disease can be very~     disabling in moderate and severe cases, whereby performing normal daily activities can become~     very problematic. The aetiology and pathogenesis are not completely understood. There is a~     genetic disposition and it is influenced by environmental factors. The disease is especially~     prevalent in white males of Northern European descent above 50 years of age. There is paucity~     of knowledge about the natural progression of the disease. Several studies have been~     conducted on progression of disease and from these studies it becomes obvious that the~     disease is progressive over several years. However, in most studies only one moment of~     follow-up has taken place, so the course of the progression over time is unknown.~      The aim of this study is to enhance our knowledge on the natural disease progression of DD at~     different stages.~   "
125628|NCT01923090|"~     The purpose of this study is to see if an enzyme in the body (5-alpha reductase, 5αR) is~     important in controlling how the body handles sugar and fat. The investigators believe that~     5αR is a crucial step in regulating these actions as well as controlling how insulin works in~     the body but regulating the amount of steroid hormones including cortisol and testosterone in~     the body. In previous clinical studies, the investigators have shown that the activity of 5αR~     increases as you gain weight and decreases with weight loss. In addition, work that the~     investigators have performed in the laboratory has shown that if you increase 5αR levels in~     liver cell grown in the laboratory, the amount of fat that they contain increases. The~     investigators would therefore like to demonstrate the effect of inhibition 5αR on the~     regulation of insulin, glucose and fat in the body.~   "
125629|NCT01923077|"~     Objective: Statins have been shown to have beneficial pleiotropic effects besides being lipid~     lowering. The investigators hypothesized that early and intensive statin treatment was~     associated with improved left ventricular (LV) function and with a stabilization of the~     coronary atherosclerotic plaques in patients with acute myocardial infarction (AMI) Method:~     In a prospective randomized blinded endpoint trial patients with ST segment elevation or non~     ST segment elevation AMI were randomized to either intensive statin-therapy (loading dose~     rosuvastatin 80 mg immediately after randomization followed by 40 mg daily) or usual statin~     therapy (simvastatin 40 mg daily). Patients were followed 12 month and the investigators~     performed echocardiography at randomization, after 30 days and after 12 month. The~     investigators used 2D Speckle Tracking for the assessment of LV-function. Coronary plaque~     assessment was done with Cardiac-CT (MSCT) at baseline and after 12 month.~      Primary outcome for this study was assessment of LV function with global and regional~     myocardial strain. Secondary outcomes can be divided in 4 groups:~        1. Additional echocardiographic measurements such as Ejection Fraction, S´, LV-volume,~          atrial volume, VA-coupling, diastolic function, post systolic strain and strain rate.~        2. Biochemical assessment of inflammation and endothelial function: Hs-CRP, ICAM, VCAM,~          E-selection and Nitrate/Nitrite ratio.~        3. Coronary plaque assessment by MSCT: Plaque volume and plaque stability.~        4. Long term follow-up: Mortality and cardiovascular events~   "
125630|NCT01923064|"~     The purpose of this randomized study to compare effect of endoscopic injection of a mixture~     of cyanoacrylate and lipiodol versus cyanoacrylate and lauromacrogol in gastric varices.~   "
125642|NCT01922908|"~     The purpose of this study is to determine if mesenchymal stem cells given by IV is feasible~     and safe in patients with recent ischemic stroke and to decide the maximum tolerated dose~     when given between 3-10 days after an ischemic stroke.~   "
125643|NCT01922895|"~     This study is being done to find out whether a diet supplemented with a probiotic nutrient~     can improve alcoholic hepatitis and gut complications compared to routine standard care.~   "
125644|NCT01922882|"~     The purpose of this trial is to test whether, compared to the normal Standard of Care at~     primary health care clinics, a home-based counseling intervention ( the 'Amagugu' Counseling~     Intervention), will increase the number of HIV-infected mothers who are able to disclose~     their own HIV status to their primary school-aged children. The investigators also wish to~     examine whether the intervention improves the quality of the maternal-child relationship,~     emotional and well-being of the child and social support.~   "
130542|NCT01858649|"~     The study is designed to analyze the pathological tumor response on resected colorectal~     cancer metastases after preoperative treatment with bevacizumab combined with FOLFOX or~     FOLFIRI regimen in a prospective cohort and to correlate this response with patient's~     outcome.~   "
125631|NCT01923051|"~     The chronic obstructive pulmonary disease (COPD) is the occurrence of chronic bronchitis or~     emphysema, a pair of commonly co-existing diseases of the lungs in which the airways narrow~     over time. This limits airflow to and from the lungs, causing shortness of breath (dyspnoea).~     In clinical practice, COPD is defined by its characteristic airflow limitation on lung~     function tests. In contrast to asthma, this limitation is poorly reversible and usually gets~     increasingly worse over time.~      The COPD registry is a non-interventional multicentre observational prospective database~     focusing on the collection and analysis of data on real mortality and morbidity in COPD~     population of the Czech Republic population of COPD patients. Monitoring is done at the~     occasion of regular check-ups, followed by retrospective search of data in the documentation,~     and a record into the registry.~      The aim of Czech National Research Database of Chronic Obstructive Pulmonary Disease is to~     establish the clinical course of severe forms of COPD, establish the cause for deterioration~     of clinical status of our patients and describe the progression of COPD to death.~      The registry fulfils general objectives of health registries such as monitoring of causes,~     development, treatment and consequences of a severe disorder, including economic and social~     impacts. Statistical and scientific analyses of the registry data are focused, in particular,~     on the assessment of health determiners of the selected patient cohort with the aim to~     improve health status of the patients.~   "
125632|NCT01923038|"~     Atelectasis involving declive areas often occurs during general anesthesia and may persist~     postoperatively. This phenomenon could be amplified by pneumoperitoneum and Trendelenburg~     position. Hypothesis: To evaluate whether the shape of the airway pressure-time curve, Stress~     Index (SI), during constant flow inflation can lead ventilator setting during general~     anesthesia.~   "
125633|NCT01923025|"~     This single center, open-label study will evaluate the PK-PDE10A Enzyme Occupancy~     Relationship of RO5545965 after a single dose in healthy male volunteers by positron emission~     tomography (PET).~   "
125634|NCT01923012|"~     Randomized placebo-controlled study with vitamine K2 (Menaquinone-4) in calcified carotid~     stenosis. We evaluate the plaque remodelling after administration of vitamine, reducing the~     calcified component.~   "
125635|NCT01922999|"~     The study will evaluate the safety and efficacy of melatonin supplementation in CKD and ESRD~     patients with sleep disorders to reduce sleep latency times, the number of apnea/hypopneic~     episodes, and prolong duration in rapid eye movement (REM) sleep in CKD and ESRD patients~     with sleep disordered breathing.~   "
125636|NCT01922986|"~     When a certain area of the brain is injured, like in stroke, several events occur. One side~     of the body may become weak. This weakness is called hemiparesis and it may create difficulty~     in performing tasks like writing, eating, and walking. The weakness results from two sources:~        1. death of some brain cells in the affected side (hemisphere) of the brain~        2. exaggerated inhibitory signals from the unaffected hemisphere acting on surviving~          neurons in the affected hemisphere.~      Investigators cannot change neurons that have died but they may be able to change the~     exaggerated inhibition that impairs the surviving neurons in the affected hemisphere.The~     purpose of this study is to try to decrease the exaggerated inhibition coming from the~     unaffected hemisphere, which suppresses the affected hemisphere, with transcranial magnetic~     stimulation (TMS). Investigators hypothesize that, from admission to discharge, active rTMS~     combined with conventional therapy will produce greater functional gains in the paretic hand~     compared to sham rTMS combined with conventional therapy, as measured by standard tests.~   "
125637|NCT01922973|"~     The overall objective of this study is to determine the extent to which circulating ghrelin~     levels (total and bioactive ghrelin) are regulated by nutritional state and age.~   "
125638|NCT01922960|"~     Predict the development of multiple organ failure in patients with trauma and severe burns.~   "
125639|NCT01922947|"~     The purpose of this research is to test the feasibility and efficacy of a brief (one session)~     preventative intervention using motivational interviewing integrated with social network~     counseling for substance use among adolescent patients in a primary care setting. One hundred~     participants will be randomly assigned to either motivational interviewing integrated with~     social network counseling or attention control conditions. The motivational interviewing~     integrated with social network counseling condition is expected to show improvement when~     compared to the attention control condition.~   "
125640|NCT01922934|"~     Obesity is common, causing many medical problems in adults (e.g., diabetes, hypertension,~     high cholesterol, sleep apnea, heart attack, strokes). A range of treatments have shown to be~     effective for treating obesity. Treatments include lifestyle modification, meal replacements,~     and weight loss medication. Most primary care settings do not provide much obesity treatment,~     though, as primary care providers (PCPs) are not well trained and because reimbursement for~     treatments is not consistent.~      Hypothesis: If PCPs have training in weight management and if most costs of treatment are~     reimbursed, we surmise that a toolbox of treatments can produce a clinically important~     weight loss amount in a large group of patients.~      Design: We propose to establish a registry of obese patients with at least one common medical~     condition related to their weight. From the registry, we will randomly select 350 people to~     be offered treatments to assist with weight loss. The remainder of the registry's patients~     can still receive obesity treatment but will not be reimbursed. We will conduct the study at~     Denver Health, a large public health care system that treats a low income, ethnically diverse~     population. All 350 patients will be offered some self-monitoring tools for weight management~     and the chance to do a computer assessment to select the right treatment for weight loss.~     Patients who complete this and record their food intake and physical activity for 1 week will~     be offered a Level 2 treatment for weight loss. Level 2 treatments include: a voucher for a~     commercial weight loss program; intensive group weight loss counseling; meal replacements;~     gym membership; or weight loss medication. Patients will choose which treatment they want,~     with the approval of their PCP. Researchers at Denver Health will help with the computer~     assessment and dispensing the treatments. We are interested in what percentage of patients~     lose at least 5% of their starting weight. We will also explore changes in glucose, blood~     pressure, and cholesterol, and we will look at how much this intervention costs and whether~     patients need less medication for their weight-related conditions at the end of the study.~      Impact: If the study is successful, we plan to take the results to the leaders at Denver~     Health to see if they will make obesity treatment more broadly available for all patients~     there.~   "
125641|NCT01922921|"~     This randomized phase I/II trial studies the side effects of vaccine therapy with or without~     polysaccharide-K and to see how well it works in treating patients with stage IV human~     epidermal growth factor receptor 2 (HER2) positive breast cancer who are receiving~     HER2-targeted monoclonal antibody therapy. Vaccines made from HER2 intracellular domain (ICD)~     peptide may help the body build an effective immune response to kill tumor cells that express~     HER2. Polysaccharide-K may stimulate the immune system in different ways and stop tumor cells~     from growing. It is not yet known whether vaccine therapy works better when given with or~     without polysaccharide-K in treating breast cancer.~   "
125645|NCT01922869|"~     The era of general dietary recommendations for the whole population may be coming to an end,~     as it is becoming apparent that we are all unique and do not respond in the same way to the~     same foods. Within a decade it is believed that doctors will be able to take profiles of~     their patients, identify specific diseases for which they are at risk and create personalised~     nutrition plans accordingly. At the University of East Anglia, UK the investigators are~     interested in particular food compounds known as flavonoids which can be found in foods such~     as chocolate, orange juice and blackberries (COB). The study will determine if factors such~     as age, gender, genetics and the bacteria present in our guts contribute to variability~     between individuals in their absorption, metabolism and excretion of flavonoids.~   "
125646|NCT01922856|"~     The purpose of the study is to determine the efficacy of a vaccine against enterotoxigenic E.~     coli (ETEC)-caused diarrhea.~   "
125647|NCT01922843|"~     The goal of this study is to test a new vitamin D compound for its ability to reduce~     parathyroid hormone levels in patients who are on hemodialysis.~   "
125648|NCT01922830|"~     This study is a randomized clinical trial with 6 months probiotic supplement vs. placebo~     treatment and 6 month follow up on 100 NAFLD patients that will undergo sleeve gastrectomy~     surgery. Measurements will be conducted at: baseline, M3 (3 months after treatment~     initiation), M6 and M12 and will include: abdominal US, Fibroscan, biochemical tests,~     anthropometric measurements, glucose breath test for bacterial overgrowth, fecal samples and~     questionnaires for demographic details, quality of life, food intake, food tolerance and~     habitual physical activity. 20 subjects will undergo an additional liver-MRI test at baseline~     and M6.~   "
125649|NCT01922817|"~     Ninety years ago the discovery of insulin and its development as a drug revolutionized the~     management of type 1 diabetes, which until that point had almost inevitably proven fatal.~     However, very rapidly it was recognized that like all wonder drugs there were problems with~     insulin. Elliot Joslin, one of the pioneers of diabetes therapy described insulin as …a~     potent preparation alike for evil and for good(1922). There are two major reasons for this.~     Firstly, in non-diabetic individuals insulin produced by the pancreas acts directly on the~     liver, the major organ for regulating blood glucose levels. In contrast, people with type 1~     diabetes inject insulin under the skin, and this is then absorbed into the circulation and~     much of it is degraded (~50%) before it gets to the liver. This means that in order to act~     effectively in the liver a type 1 diabetic needs to inject at least double the amount of~     insulin. Many studies have now shown that high insulin levels lead to weight gain,~     accelerated blood vessel disease (atherosclerosis) and a higher risk of suffering low blood~     glucose (hypoglycaemia). A second major problem is that individuals with type 1 show high~     levels of the hormone, glucagon. Glucagon is also produced in the pancreas and is normally~     regulated by pancreatic insulin, so the loss of this effect in people with type 1 diabetes~     means they run high glucagon levels. This has been shown to increase blood glucose,~     particularly after a meal. It is because of this that the diabetes community has called for~     novel therapies that can reduce high insulin levels and high glucagon levels. A new class of~     drugs called dipeptidylpeptidase IV inhibitors (DPPIVi) are currently used to treat people~     with type 2 diabetes. DPPIV inhibition increases endogenous levels of glucagon like peptide-1~     (GLP-1). These drugs have a number of actions but the most relevant to this application is~     that they directly suppress glucagon, induce satiety (i.e. reduce hunger and leads to a~     reduction in body weight) and indirectly reduce the need for high dose insulin injections.~     This makes them an ideal candidate drug as an insulin sparing or adjunct therapy in type 1~     diabetes, but there is very limited data to date for this use. We would like to run a small,~     pilot, randomised, cross over trial that investigates the potential for DPPIVi therapy to~     reduce insulin requirements in type 1 diabetes. We would like to investigate to see if this~     drug reduces daily insulin doses, leads to weight reduction, reduces blood glucose~     fluctuation and improves glucose control. Through reduction of blood glucose variability, we~     want to investigate, whether it has the capability of improving the magnitude of epinephrine~     responses at 2.5mmol/L by performing a hyperinsulinaemic, hypoglycaemia clamp study after~     each arm. A successful outcome would then lead to an application for funds for a larger,~     multicentre intervention study. The benefits of this therapeutic advance are clear and this~     has the potential to make a dramatic improvement to the lives of people with type 1 diabetes~     in our community.~   "
125650|NCT01922804|"~     The aims of the present study are to investigate the effect of vitamin K2 on bone turnover,~     bone mass, bone structure, glucose metabolism, and arteriosclerosis.~      Osteoporosis, diabetes, metabolic syndrome and cardiovascular disease are common diseases~     that affect large groups of people in the Western world.~      Our hypotheses is that vitamin K2 (MK-7) reduces undercarboxylated osteocalcin in~     postmenopausal women and reduces bone turnover and increases bone mineral density; increases~     insulin sensitivity and decreases indices of arterial calcification.~   "
125651|NCT01922791|"~     A randomized double-blind placebo controlled intervention study with pregnant obese women~     (n=440) will be conducted. The intervention will involve consumption of fish oil and/or~     probiotic capsules from early pregnancy until 6 months after delivery.~      The aim of the study is firstly to investigate the effects of the supplements on the risk of~     gestational diabetes mellitus and obesity in the women and secondly to modify the risk~     markers of allergy and obesity in children of the women. Also the underlying metabolic~     mechanisms will be investigated.~   "
125652|NCT01922778|"~     The purpose of this study is to develop an endometrial biopsy screening program for~     endometrial cancer and its precursor lesions in overweight and obese women.~      There is a BMI threshold at and above which optimal screening parameters exist for~     identifying endometrial cancer and its precursor lesions in overweight and/or obese women.~     Prevention, diagnosis and treatment of endometrial cancer and its precursor lesions in~     overweight and/or obese women offers substantial health benefits.~   "
125653|NCT01922765|"~     If we compare eradication rate of Helicobacter pylori divided to 4 groups: amoxicillin,~     rabeprazole, clarithromycin(AOC), amoxicillin, rabeprazole, metronidazole(AOM), treated with~     amoxicillin, rabeprazole for 5 day, followed by clarithromycin, metronidazole, rabeprazole~     for 5 days(sequential), amoxicillin, clarithromycin, metronidazole, rabeprazole(concomitant),~     then the eradication rate of concomitant group will be the highest.~   "
125654|NCT01922752|"~     The primary objective is to determine the maximum tolerated dose (MTD), safety, and~     tolerability of oral CEP-37440 administered daily to patients with advanced or metastatic~     solid tumors.~   "
125655|NCT01922739|"~     This is a 6-month, nonrandomized, open-label extension study to assess the long-term safety~     of hydrocodone bitartrate extended-release (ER) tablets in patients with moderate to severe~     chronic low back pain who require continuous opioid treatment for an extended period of time.~      To be eligible for Study 3104, patients were required to have completed the entire double~     blind treatment period on study drug (either placebo or hydrocodone bitartrate ER tablets)~     through week 12 of Study 3103 (NCT01789970) and to have met the entry criteria for Study~     3104.~   "
125656|NCT01922726|"~     The purpose of the study is to evaluate at 12 Months follow-up the association between Atrial~     Fibrillation (AF) and Sleep Apnea (SA) severity based on data measured and stored in REPLY~     200 DR pacemaker.~   "
125657|NCT01922713|"~     The purpose of the study is to determine whether daily consumption of beta-carotene~     biofortified maize will increase breast milk retinol concentration in lactating Zambian~     women.~   "
125658|NCT01922700|"~     Pepper sprays and pepper gas grenades are used by riot police at various places in the world~     for crowd control. Data about the acute effects based on human studies is extremely scarce.~     Kashmir valley in the northern Indian state of Jammu & Kashmir has witnessed political~     turmoil for the past 22 years and incidents of stone pelting are common wherein groups of~     youth indulge in stone pelting at the security personnel. While there have been previous~     episodes of fatalities associated with incidents of firing by the security personnel; non~     lethal methods are adopted routinely now. These include lathis, water cannons, tear gas and~     more recently the pepper gas grenades. The pepper grenades explode in the area and the~     adverse effects are perceived by the population in the area too who are even sitting in their~     homes. The study proposes to observe the health effects of the pepper gas exposure in~     non-combatant civilians.~   "
125659|NCT01922687|"~     The primary objective of this study is to test the hypothesis that amlodipine plus~     atorvastatin given in a single tablet (Caduet), compared with amlodipine alone (Norvasc), has~     a stronger effect in protection of arterial structure and function.~   "
125660|NCT01922674|"~     Purpose: To determine if observation (watchful waiting is a safe alternative to routine~     repair of asymptomatic inguinal hernias in adult males.~      Scope: Traditionally surgeons are taught that all inguinal hernias should be repaired at~     diagnosis to prevent the life threatening complications of bowel obstruction or incarceration~     with strangulation and that operation becomes more difficult the longer a hernia is left~     un-repaired.~   "
125661|NCT01922661|"~     The primary objective of the study is to assess the safety and tolerability of single~     ascending doses of subcutaneously (SC) administered REGN1908-1909 in allergic, adult~     subjects.~   "
125662|NCT01922648|"~     Respiratory Syncytial Virus (RSV) is a virus that causes chest infections. It is the single~     most important cause of severe respiratory illness in infants and young children, and severe~     RSV infection early in life is associated with an increased risk of later developing asthma.~     RSV also causes severe disease in elderly and immune-compromised adults, and the amount of~     RSV disease in the elderly is similar to that from seasonal flu. The virus is transmitted in~     the secretions of the upper respiratory tract of infected individuals and by contact with~     contaminated surfaces (such as toys). Hospital outbreaks, especially on paediatric and~     neonatal wards, are not uncommon.~      Infection by RSV does not develop a natural long-lasting protection against re-infection~     (like, for example, measles does). In the USA nearly all children by 24 months of age have~     been infected at least once with RSV, and about half will have experienced two infections.~     There is no effective anti-viral drug to treat an infection and the only way of managing~     cases of severe infection is through supporting organs, such as the lungs, to withstand and~     recover from the illness.~      There remains a real need to develop an effective vaccine to prevent severe infections caused~     by RSV. A better understanding of the way the immune system responds to RSV in children would~     aid the development of such a vaccine.~      The purpose of this study is to increase our understanding of how the immune system responds~     to RSV. Only limited data is available on some important components of the immune response~     and this study is designed to measure these in more detail. This is done using a single blood~     sample.~      A total of 35 children are anticipated to be recruited to this study, at ages when we expect~     to see differences in the immune response to RSV;~        -  5 infants aged between 2 and 4 months (Group 1), who have not yet been exposed to RSV~        -  20 infants aged between 6 and 12 months (Group 2), who will have had exposure to one~          single RSV season in the winter of 2011/12~        -  10 children aged between 3 and 6 years (Group 3), who have been exposed to RSV over~          several winter seasons~   "
125663|NCT01922635|"~     The constitutional lymphœdema is a rare disease with an annual incidence before the age of 20~     years considered at 1,15/100 000. This chronic, incurable disease without hiring directly the~     prognosis for survival, alter the body image imposing a visible deformity and of which the~     treatment which aims at reducing and at stabilizing the physical deformation is binding and~     expensive. The lymphœdema is a crippling disease of the child. As such, it rings on the~     everyday life of the child and on the family environment. This question is all the more~     important, that all the studies show that the success of the treatment bases on the~     compliance in the concentration and in the care of hygiene. The parameters of the success of~     these treatments at the child are not known.~   "
125664|NCT01922622|"~     Fractured neck of femur (FNF) is a common cause of admission to hospital in elderly patients~     with multiple comorbidities. Anaesthetic management of this patient group is extremely~     challenging.Neuraxial anaesthesia with minimum doses of local anaesthetic agents administered~     via a spinal catheter leads to better cardiovascular stability.The minimum dose of local~     anaesthetic with intrathecal fentanyl was not established yet.We propose to study and~     determine the initial minimum local anaesthetic dose (MLAD) of 0.5% bupivacaine with 20 mcg~     of fentanyl administered via a spinal catheter to achieve a sensory block up to T10 for the~     operative fixation of FNF.We will use a previously well established Dixon and Massey~     up-and-down method to calculate initial MLAD in this prospective, observational trial.~      Objectives: We would like to determine the initial MLAD of 0.5% bupivacaine with 20mcg of~     fentanyl administered via a spinal catheter required to achieve a sensory block up to T10 on~     the side of FNF.~      Outcomes~      Primary outcome:~        1. Initial MLAD of 0.5% bupivacaine with 20mcg of fentanyl required for a sensory block up~          to T10 on the side of FNF.~           Secondary outcomes:~        2. Total dose of 0.5% bupivacaine with 20mcg of fentanyl required for the operative~          fixation of fractured neck of femur.~        3. The effect on haemodynamic variables (blood pressure, heart rate).~        4. Incidence of side effects~        5. The length of postoperative analgesia (the time from the last dose of local anaesthetic~          administered intrathecally to VAS>3).~        6. The time to first rescue analgesic requirement~      Study Design Prospective, observational trial.~      Study Size Based on the previously well established Dixon and Massey up-and-down~     method(10), we will recruit patients until a successful spinal block has been achieved in~     six consecutive patients who received a specific dose. This is the requirement to calculate~     the initial MLAD.~   "
125665|NCT01922609|"~     The aim of this observational pilot study is to determine whether intolerance of carotid~     occlusion during carotid artery stenting can be predicted with preprocedural transcranial~     Doppler evaluation.~   "
125666|NCT01922596|"~     The purpose of the study is to compare the effect of a Adductor Canal Blockade (ACB) vs a~     Femoral Nerve Blockade (FNB), on muscle strength, mobility and pain in patients with severe~     pain (VAS pain score > 60) after Total Knee Arthroplasty (TKA.~   "
125667|NCT01922583|"~     This is an open-label, single-arm, multicenter phase II trial in patients with stage IV EGFR~     T790M, EGFR exon 20 and other uncommon, HER2, or BRAF-mutated; ALK, ROS1, or RET-rearranged~     NSCLC.~   "
125668|NCT01922570|"~     Enteral nutrition (EN) is the first choice route for nutritional support in ICU patients with~     a functioning digestive tract. Nevertheless, EN alone is often associated with digestive~     intolerance, including diarrhoea. In case of diarrhoea, EN is often reduced or discontinued,~     resulting in insufficient energy and protein intakes and increase complications rate in ICU~     patients. Diarrhoea is more frequent in ICU patients receiving EN that in those without EN or~     on Parenteral nutrition (PN). This difference is likely to be related to the level of EN~     administration needed to optimize the coverage of nutritional needs at a time when the gut~     has reduced absorptive capacity. Diarrhoea is suspected to have a negative economic impact on~     global cost, because the management of patients with diarrhoea is time-consuming for the~     nurses and all medical staff, it requires investigations (water and electrolytes balances,~     microbiology investigations, etc.) and treatments (anti-diarrhoeal drugs, antibiotics, etc).~     However, the economic impact of diarrhoea related to EN or the combination of EN and PN has~     never been evaluated in the ICU setting.~   "
125669|NCT01922557|"~     To study the association of the thoracic fluid content and acute lung injury during liver~     transplantation.~   "
125670|NCT01922544|"~     In patients undergoing CRT device implantation a lead positioning in the coronary sinus is~     required. Even this part of the surgical procedure is challenging. In this study we compared~     retrospectively to methods of CS-lead implantation: conventional vs. EP-catheter guided.~   "
125671|NCT01922531|"~     To measure Axonal Injury in children with mild traumatic brain injury enrolled in an~     Emergency Department using Diffusion Tensor Imaging, a type of MRI and biomarkers.~   "
125672|NCT01922518|"~     Typically pacemaker electrode has been attached to the right ventricular apex. This method~     lead to Non-physiological Ventricular contraction. It has been reported to cause by~     ventricular dysfunction. In conclusion, this study demonstrate that impact of right~     ventricular pacing determined by electrocardiography was planned.~   "
125673|NCT01922505|"~     The purpose of this study is to investigate the trend of eradication rates of first-line~     triple therapy for Helicobacter pylori in recent ten years and clinical factors that affect~     the eradication in Korean.~   "
125674|NCT01922492|"~     -  Effects of autologous islet transplantation were compared to those of oral anti-diabetic~          drugs after distal pancreatectomy.~        -  The primary interest is a insulin-secretory function after the surgery in two~          intervention groups.~   "
125693|NCT01922245|"~     This project will investigate the use of noninvasive brain stimulation in the form of tDCS~     (transcranial direct current stimulation) in conjunction with speech-language therapy, for~     the improvement of language production in stroke survivors with aphasia. The hypothesis is~     that anodal tDCS and speech-language therapy will facilitate improved outcomes compared to~     speech therapy alone.~   "
125675|NCT01922479|"~     Heart failure (HF) is a major global public health issue which also affects Asia. Data from~     the National Registry of Disease in Singapore shows a 9.4% rise in HF admissions in public~     hospitals from 2008 to 2009 (4140 to 4530). Anaemia (low blood Haemoglobin level) is a common~     problem occurring in HF, ranging from 14% to 56% in outpatient registries and clinical~     trials. Anaemia exacerbates the basic symptoms of HF of dyspnea and exercise intolerance,~     thereby reducing quality of life (QoL). However, recent approaches aimed at improving and~     normalizing Haemoglobin have been unsuccessful.Novel approaches are required to address this~     problem. Iron deficiency (ID) is a well-understood cause of anaemia. ID without overt anaemia~     may be present in HF patients. A recent study by Jankowska et al published in 2010 of 546 HF~     patients showed a 37% prevalence of ID, regardless of Haemoglobin level. This was associated~     with worse outcomes including impaired exercise capacity. The presence of ID indicates a~     higher likelihood of deteriorating and dying early. A landmark study published in the New~     England Journal of Medicine (The Ferinject Assessment in Patients with Iron Deficiency and~     Chronic Heart Failure (FAIR-HF) study) showed that HF patients who were treated with IV iron~     in the form of Ferric Carboxymaltose (FCM) had better outcomes, including improved exercise~     capacity, overall function, and quality of life.~      There is a lack of contemporary data on ID in HF patients in Asia, including data on~     treatment with this novel IV iron FCM.~      Hypothesis We hypothesise that treating ID in HF patients in Asia using FCM will improve~     outcomes including exercise capacity, quality of life, overall functional status, and the~     need to be hospitalised for complications arising from HF.~   "
125676|NCT01922466|"~     The purpose of this study is to evaluate the efficacy and safety of east-west collaborative~     treatment using bee venom acupuncture and NSAIDs on pain intensity, functional status and~     quality of life of patients with chronic cervicalgia~   "
125677|NCT01922453|"~     This international study is looking to see if the addition of music and sound on the maternal~     abdomen encourages fetal position change from breech to vertex in near term women.~   "
125678|NCT01922440|"~     This is a prospective, observational disease and drug registry designed to evaluate the~     safety and effectiveness profile of rhPTH(1-84) under conditions of routine clinical practice~     and to observe the clinical course of chronic hypoparathyrodism. No treatment is provided as~     a result of participating in this registry and all decisions on the participant's treatment~     are determined by his or her physician.~   "
125679|NCT01922427|"~     The purpose of this study is to see if use of RNS60 during ACL reconstruction surgery~     decreases pain and improves functional capacity post-operation.~   "
125680|NCT01922414|"~     This study will be conducted to compare the results of Laser and ultrasonic lithotripsy in~     disintegration of staghorn stones during percutaneous nephrolithotomy.~   "
125681|NCT01922401|"~     for evaluating inverse ratio ventilation of laparoscopic bariatric surgery~   "
125682|NCT01922388|"~     Although deep brain stimulation of the subthalamic nucleus(STN DBS) has become the surgical~     treatment of choice for Parkinson's disease(PD), a consensus on the timing of surgery is~     lacking. This study is intended to demonstrate that early, compared with delayed,~     introduction of STN DBS is more beneficial for PD patients who have developed motor~     complications.~   "
125683|NCT01922375|"~     This study is designed to evaluate the efficacy and safety of Naftopidil in Korean male~     patients with with lower urinary tract symptoms associated with benign prostatic hyperplasia.~      The investigators hypothesized that Naftopidil which came onto marcket in Japan would effect~     in improvement of voiding and storage difficulty.~      Design:~      Placebo-controlled, Randomized, Double-blind, Double-dummy, Parallel group, Fixed dose design~   "
125684|NCT01922362|"~     To compare the efficacy and safety of negative pressure drainage system with controls~     (indirect saline soaks) in the coverage of recipient site wounds of split-thickness skin~     graft.~   "
125685|NCT01922349|"~     Safety, tolerability and pharmacokinetics of single and multiple oral doses of BI 113608 in~     healthy Chinese, Japanese and Caucasian male volunteers.~   "
125686|NCT01922336|"~     The purpose of this study is to compare the pharmacokinetics, safety, tolerability and~     immunogenicity of SB2 and Remicade (EU sourced Remicade and US sourced Remicade) in healthy~     subjects.~   "
125687|NCT01922323|"~     The PI will study metabolism during liver regeneration in living liver donors~   "
125688|NCT01922310|"~     The overarching aim of this study is to examine the process of organ donation decision-making~     and to determine whether changes in requesting practices change rates of consent for~     donation, and other family-based outcomes.~   "
125689|NCT01922297|"~     This study will determine the clinical effectiveness, moderators and mechanisms of change,~     and economic impact of an integrative, family-based intervention that concurrently targets~     change in HIV/Sexually Transmitted Disease (STD)-associated risk behaviors, drug abuse,~     delinquency, arrest and mental health outcomes for juvenile offenders committed to a juvenile~     justice day treatment program.~   "
125690|NCT01922284|"~     UKHVC Spoke 003 is a randomised Phase I, two centre study which will explore the impact of~     shortening a vaccination regimen using deoxyribonucleic acid (DNA) (CN54ENV and ZM96GPN),~     Modified Vaccinia Ankara - C (MVA-C) and CN54rgp140 adjuvanted with glucopyranosyl lipid A~     adjuvant - aqueous form (GLA-AF). The study population will be 40 healthy male and female~     volunteers 18 to 45 years old who are at low risk of HIV infection are to be recruited.~      Study participants will be immunised with trial immunogens:~        -  8mg DNA: one plasmid encoding a gag-pol-nef polypeptide derived from the 96ZM651-8 clone~          and one plasmid encoding gp140 env derived from clade C 97CN54~        -  1.108 TCID50 MVA-C (nominal titre) expressing the gag-pol-nef and gp120 env proteins~          derived from clade-C 97CN54~        -  100ug CN54rgp140, a trimeric recombinant envelope protein derived from clade C 97CN54~        -  5ug GLA-AF, an aqueous glucopyranosyl lipid A adjuvant~      All immunisations will be administered by the intramuscular route (IM). CN54gp140 and GLA~     will be mixed together before administration, and immunogens will be delivered in combination~     regimens~   "
125691|NCT01922271|"~     The purpose of this study is to further figure out differences of glycopyrronium bromide~     compared to tiotropium in early bronchodilation measured by a comprehensive assessment of~     lung function that includes hyperinflation and specific airway resistance in patients with~     moderate to severe COPD.~   "
125692|NCT01922258|"~     To compare the efficacy of flexible dosing of brexpiprazole with placebo in subjects with~     agitation associated with dementia of the Alzheimer's type~   "
125694|NCT01922232|"~     This is a prospective study of pretreatment DW-MRI to identify potential imaging biomarkers~     predictive of response to neoadjuvant chemotherapy in patients with muscle-invasive bladder~     cancer. Target enrollment of this study is 40 patients. Patients will first undergo baseline~     DW-MRI of the Abdomen and Pelvis prior to beginning standard treatment with neoadjuvant~     cisplatin-based chemotherapy after which DW-MRI will be repeated to assess for response or~     progression. Patients who remain eligible for surgery will proceed to standard radical~     cystectomy with pelvic lymph node dissection. DW-MRI metrics including apparent diffusion~     coefficient (ADC) values will be correlated to pathologic response rate in the radical~     cystectomy specimen to identify imaging markers predictive of response.~   "
125695|NCT01922219|"~     The purpose of this research study is to learn whether specific types of brain imaging and~     psychological testing can predict how much benefit patients with depression will receive from~     a well-studied psychotherapy for depression, called cognitive behavioral therapy (CBT), and~     how the brain imaging and psychological tests change with treatment. We will also be~     comparing brain scans from this study between individuals suffering from depression and~     volunteers without depression.~      This study offers 14 sessions of one-on-one cognitive-behavioral therapy (CBT) over twelve~     weeks, administered by an experienced doctoral-level psychologist or psychiatrist.~   "
125696|NCT01922206|"~     The purpose of this Collaborative R01, under Program Announcement PAR-09-153, is to conduct a~     full-scale trial of an intervention to assist mothers living with HIV (MLH) with disclosing~     their serostatus to their young age 6 - 14 year old), well children. A pilot study of the~     intervention has recently been completed (R01 MH077493) and met its major aims. The basis for~     development of the pilot intervention was work from three R01s (MH057207, currently Yr. 14)~     designed to longitudinally assess MLH and their children. Within that work, several studies~     were conducted on maternal disclosure, suggesting disclosure is difficult, and outcomes for~     MLH and children could be improved by intervention. The pilot study, known in the community~     as Teaching, Raising, And Communicating with Kids (TRACK), was based on integrative~     disclosure theory. Results of the pilot trial indicate that those in the intervention group~     were six times more likely to disclose their HIV/AIDS status to their child than those in the~     control group (O.R. 6.33); by the 9-month follow-up 33% of intervention MLH disclosed,~     compared to only 7.3% of the control group. Perhaps more importantly, the intervention~     group's emotional functioning and their satisfaction improved significantly following the~     intervention, compared to the control group. Similarly, child mental health indicators among~     children of intervention MLH were significantly better than control group children at~     follow-ups. In this study, TRACK II, we propose to conduct a full-scale trial of the~     intervention in two sites: (1) Los Angeles county (Site 1, where the pilot trial was~     conducted), which will include a high proportion of Latina families and a smaller proportion~     of African-American and White families; and (2) Atlanta, Georgia (Site 2, where the primary~     consultant on the pilot trial conducts research), which will include a high proportion of~     Southern African-American families, as well as White families. MLH and their children (N =~     440 total; 110 mothers and 110 children per site, n = 220 per site) will be assessed at~     baseline and at 3, 9, and 15-month follow-ups. MLH will be randomly assigned to the~     intervention or control. Aims are to:~        1. facilitate disclosure of the mothers' HIV status to the children, which will include~          secondary aims of:~             1. increasing mothers' self-efficacy to disclose and respond to child questions~               regarding HIV;~             2. reducing mothers' fears regarding disclosure and stigma;~             3. improving maternal knowledge of child development and how to provide appropriate~               levels of information given the age of the child;~        2. improve MLH mental health indicators over time (i.e., depression, anxiety, quality of~          life);~        3. improve child mental health indicators over time (i.e., depression, anxiety, acting out~          behaviors); and~        4. improve family functioning indicators (e.g., cohesion, perceived closeness between~          mother and child).~   "
125697|NCT01922193|"~     Evaluate the efficacy and safety of of Highly Purified Urofollitropin for Injection Compared~     to Recombinant Human Follitropin Alfa for Injection in Chinese Females Undergoing an Assisted~     Reproductive Technology (ART) Program.~   "
125698|NCT01922180|"~     To describe Computed Tomography (CT) features associated with severe exacerbations of Chronic~     Obstructive Pulmonary Disease (COPD).~   "
125699|NCT01922167|"~     Frailty is a clinical entity associated with an increase in risk for disease and death and~     becomes more common as people age. Frailty has a strong relationship with the age-related~     loss of muscle and strength, termed sarcopenia. Sarcopenia and frailty are strongly~     associated with disability, especially in women. Adequate protein intake, the amino acid~     leucine, and resistance exercise training have been individually shown to increase muscle~     mass to varying degrees. However, no studies have investigated how a longer-term resistance~     exercise training program with leucine supplementation when protein intake is optimized could~     increase muscle mass in frail and pre-frail elderly women. In addition, this is the~     population that stands the most to gain from such an intervention.~      The purpose of this study is to investigate the effects of the amino acid leucine added to~     resistance exercise training on muscle mass and physical performance in frail and pre-frail~     elderly women with adequate protein intake. We hypothesize that combining leucine in diet~     with an exercise program would be superior to exercise alone in stimulating muscle protein~     synthesis and phosphorylation status of muscle cellular key-regulatory proteins, leading to~     enhanced gains in muscle performance.~      A total of 24 subjects will take part in this study, conducted at the McGill University~     Health Centre (MUHC) Royal Victoria Hospital and the Institut Universitaire de Gériatrie de~     Montréal (IUGM). All subjects will undergo adjustments to their diet to optimize protein~     intake and a resistance exercise training program. Half of the participants will receive a~     supplement of powdered leucine (an amino acid), and the other half of the participants will~     receive a placebo in the same powder form. Neither the participants nor the study~     investigators will know which participants are receiving the leucine nor which are receiving~     the placebo.~      Each subjects participation in this study will involve 4 total visits: 2 initial screening~     visits followed by 2 two-day stays at the Centre for Innovative Medicine (CIM) of the~     MUHC-Royal Victoria Hospital. These two stays will be spaced by 12 weeks of the intervention~     (dietary adjustments, resistance exercise training, and the powdered supplement). The two~     stays each consist of a meal test to assess each subjects metabolic responses to a meal, and~     to obtain muscle biopsies necessary to measure the rate of protein accumulation in the~     muscle. Simple physical performance measurements will be taken before and at the completion~     of the intervention.~      This study aims to better understand how the presence of aging affects the body's responses~     to resistance exercise and how leucine, one of the amino acids that make up proteins, may~     help build muscle. This in turn, could lead to defining combined diet and exercise strategies~     to prevent muscle loss often seen with aging.~   "
125700|NCT01922154|"~     To evaluate the effects of intravitreal ranibizumab (IVR) as adjunctive treatment for~     trabeculectomy with mitomycin C (TMC) in neovascular glaucoma (NVG).~   "
125701|NCT01922141|"~     This study is designed to compare the blood pressure lowering efficacy of aliskiren, a~     combination of aliskiren plus amlodipine, and ramipril in elderly patients with mild to~     moderate hypertension. It will also compare the long-term safety of an aliskiren-based~     regimen to a ramipril-based regimen~   "
125702|NCT01922128|"~     Study to evaluate the safety and tolerability of MC-1101, a potential topical treatment for~     non-edxudative age Related Macular Degeneration (AMD) in medically stable individuals.~   "
125703|NCT01922115|"~     Anticholinergic medication is used to treat overactive bladder (OAB). A known side effect of~     this medication is cognitive dysfunction. OAB is more prevalent in the elderly population - a~     group that also has a higher baseline risk of cognitive dysfunction. Our objective is to~     evaluate the effect of an anticholinergic medication on cognitive function in elderly women.~   "
125704|NCT01922102|"~     This study is designed to evaluate the efficacy and safety of two different dosing regimens~     of 0.5 mg ranibizumab given as intravitreal injection in comparison to verteporfin PDT in~     patients with visual impairment due to choroidal neovascularization secondary to pathologic~     myopia (PM)~   "
125705|NCT01922089|"~     The purpose of this study is to assess the safety and tolerability of initiating LCZ696 in~     heart failure patients with reduced ejection fraction (HF-rEF) using conservative (reaching~     target dose over 6 weeks) and condensed (reaching target dose over 3 weeks) up-titration~     regimens.~   "
125706|NCT01922076|"~     This phase I trial studies the side effects and the best dose of WEE1 inhibitor AZD1775 when~     given together with local radiation therapy in treating children with newly diagnosed diffuse~     intrinsic pontine gliomas. WEE1 inhibitor AZD1775 may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy~     x-rays, gamma rays, neutrons, protons, or other sources to kill tumor cells and shrink~     tumors. Giving WEE1 inhibitor AZD1775 with local radiation therapy may work better than local~     radiation therapy alone in treating diffuse intrinsic pontine gliomas.~   "
125707|NCT01922063|"~     Hitherto no comprehensive long-term follow-up data of 10 years and more have been obtained~     from survivors of disc surgery that would have considered the type of postoperative care.~      Objectives: 1) To evaluate the long-term effects of postoperative comprehensive physiotherapy~     starting 1 week after lumbar disc surgery. 2) To assess the relative risk of segmental~     instability in the operated segment 12 years following lumbar disc surgery.~   "
125708|NCT01922050|"~     Part 1:~      To identify Maximum Tolerated Dose (MTD) levels of two formulations of LEO 43204 after once~     daily treatment for two consecutive days~      Part 2:~      To evaluate efficacy of two formulations of LEO 43204 in two doses after once daily treatment~     for two consecutive days compared to vehicle formulations~   "
125709|NCT01922037|"~     This multicenter, prospective study will evaluate the baseline participant characteristics~     (including biomarkers) associated with a variety of individual and composite clinical~     outcomes in participants with moderate to severe asthma initiating treatment with omalizumab.~   "
125710|NCT01922024|"~     The Curetis Unyvero LRT55 Application is intended to detect and to identify genes of 21~     microorganisms and 19 genes associated with antibiotic resistance in 4 hours.~      In this study, the performance of the Unyvero LRT55 Application shall be tested under~     clinical conditions and compared to (1) a composite reference method (for non-atypical or~     cultured microorganisms) or (2) a molecular PCR based reference method for the 3 atypical~     microorganisms Chlamydophila pneumoniae, Legionella pneumoniae, and Pneumocystis jirovecii,~     and for resistance genes.~      PCR amplifications are followed by bi-directional sequencing, including comparison of the~     test results Time to result will be compared for the Unyvero LRT55 Application and~     standard-of care.~   "
125711|NCT01922011|"~     The purpose of the study is to determine whether daptomycin is effective and safe in the~     treatment of pediatric participants with AHO when compared to vancomycin (or equivalent) or~     nafcillin (or β-lactam equivalent). The primary hypothesis is that daptomycin is non-inferior~     compared with vancomycin (or equivalent) or nafcillin (or β-lactam equivalent) with respect~     to improvement in Pain, Inflammation, and Limb Function on or before study Day 5.~   "
125712|NCT01921998|"~     Side effects from chemotherapy can be severe in some patients leading to admission to~     hospital, a worse quality of life and delays in subsequent doses of chemotherapy. A blood~     test that could predict patients who will go on to develop severe side effects could be~     useful and might allow early intervention with medicines to reduce the severity of the~     symptoms and prevent admission to hospital.~      This study will collect blood samples from patients with lymphoma or sarcoma who are~     receiving chemotherapy (with an expected admission rate for neutropenic sepsis, one of the~     side effects that most commonly results in hospital admission, of less than 20%). It will~     assess whether changes in blood proteins (biomarkers) taken 2 days after the 1st~     chemotherapy can predict subsequent severe side effects throughout the 4 months of~     chemotherapy. In addition the investigators will collect data on quality of life and contact~     with medical professionals to assess the costs of chemotherapy toxicity to both the patient~     and health service. This will allow us in the future to model the cost effectiveness of using~     biomarkers in this manner to try and reduce chemotherapy toxicity.~   "
125713|NCT01921985|"~     This study investigates if the administration of terlipressin reduces complications after~     major liver surgery.~   "
125714|NCT01921972|"~     This is a national multicenter, double-blind, randomized, parallel-group trial of 12 months~     in duration. Following a 4 week wash-out period, subjects will be randomized to one of 2~     treatment groups: (1) galantamine CR 24 mg/day with dose-titration over twelve~     weeks[maintenance phase from week 9], (2) a combination of galantamine CR 24 mg/day plus~     memantine 10 mg b.i.d. with a dose titration of sixteen weeks (12 weeks for galantamine~     [maintenance phase from week 9], additional 4 weeks for memantine).~   "
125715|NCT01921959|"~     The purpose of this ancillary study is to determine whether a behavioral weight loss~     intervention for postpartum mothers (5R01DK087889-02, PI Phelan; Co-I Tate) has a positive~     ripple effect on weight and health of partners and children/offspring.~   "
125716|NCT01921946|"~     A phase Ⅰ study to evaluate the pharmacokinetic interactions and safety between fimasartan~     and rosuvastatin in healthy male volunteers.~   "
125717|NCT01921933|"~     The objective of this study is to assess the performance and safety of the Optiflow~     Anastomotic Connector (Optiflow) when used to facilitate the creation of autogenous~     arteriovenous fistula (AVF) anastomoses.~   "
125718|NCT01921920|"~     This is An Open-label, Randomized, Single-center, 4-way Crossover, Single dose Bioequivalence~     Study Comparing Omeprazole 20 and 40-mg Aqueous solvent Based Capsules Manufactured by~     AstraZeneca with Omeprazole 20 and 40-mg Organic-solvent Based Capsules Manufactured by Merck~   "
125719|NCT01921907|"~     A topical treatment applied twice daily for 4 weeks to induce disappearance of facial actinic~     keratosis (AK). First 4 weeks treatment (visit 1, 2 and 3 at 0,2 an 4 weeks) treated as a~     double blind parallel study. From weeks 4 to 7 (visit 3 to visit 4) all patients to be~     treated by the active component.~   "
125720|NCT01921894|"~     This study of vitamin D is designed to assess both the safety and efficacy of potential doses~     (2,000 IU/day and 4,000 IU/day) in raising a vitamin D level to a normal range in a short~     period of time (e.g. 4 weeks or less) compared to 200 IU/day.~      In children with vitamin D insufficiency or deficiency who are at risk for severe asthma~     exacerbations, we hypothesize that both vitamin D supplementation with 4,000 IU/day and 2,000~     IU/day will safely achieve normal vitamin D levels, but that the higher dose (4,000 IU/day)~     will result in a larger proportion of subjects achieving this level at 4 and 8 weeks.~   "
125721|NCT01921881|"~     The goal of the study is to examine if healthy individuals that ingest St John's wort will~     have a significantly difference in glucose tolerance.~   "
125723|NCT01921855|"~     This is the first in humans study of BAY86-6150 (B0189) in non-bleeding subjects with~     moderate or severe congenital hemophilia A or B with or without inhibitors. This is a~     randomized, double-blind, placebo-controlled, single-dose, dose escalation study. It is~     designed to investigate the safety, tolerability, potential immunogenicity, pharmacokinetic~     and pharmacodynamic profile of BAY86-6150 (B0189) and to determine a dose or range of doses~     to be examined in subsequent studies.~   "
125724|NCT01921842|"~     The study is an evaluation of a nutrition and physical activity intervention in child care~     centers in NC, CA, and CT.~   "
125725|NCT01921829|"~     This research study is a randomized clinical trial to evaluate if taking diuretics~     (medications that increase urine production and help with fluid removal from the body) in a~     standardized fashion (using a guideline for adjusting doses based on measured urine output)~     could improve health outcomes in patients with cardiorenal failure or cardiorenal syndrome~     (combined heart and kidney failure) with edema (too much fluid in their arms, legs, and/or~     lungs). Under usual care, these patients are treated with diuretics and other medications in~     increasing doses, but not necessarily to maintain a specific amount of urine output per day.~     Current heart failure (HF) treatment guidelines do not provide any standard protocol, or~     guideline, for adjusting diuretic doses. At the point when kidney function worsens to the~     degree that the kidneys are no longer able to respond to the medications used to remove~     fluid, either ultrafiltration (UF) or dialysis (also called hemodialysis [HD]) is typically~     started in order to remove fluid. In both UF and dialysis, excess fluid is removed from the~     body by using a machine. In dialysis, both waste products and fluid are removed and~     electrolyte abnormalities are corrected. In UF, only fluid is removed. Both procedures use~     the same machine. This study will test whether a Protocolized Diuretic Strategy (ProDiuS), a~     plan for adjusting diuretic doses based on measured urine output, will improve clinical care~     for cardiorenal syndrome. Such a plan for adjusting diuretic doses is needed to improve~     symptoms, decrease the length of hospital stays and rehospitalization rates, and improve~     health-related quality of life (HRQOL) in cardiorenal syndrome patients.~   "
125726|NCT01921816|"~     The investigators aim to examine the efficacy and safety of using a new citrate containing~     commercially available solutions (Prismocitrate 18/0) as the regional citrate anticoagulation~     in continuous renal replacement therapy for critically ill patients.~   "
125727|NCT01921803|"~     External beam radiotherapy (RT) is one of the standard curative treatment options for~     patients with prostate cancer (PC). Several randomised trials have shown excellent long-term~     biochemical outcome with higher radiation doses. Nowadays, RT for PC commonly consists of~     delivering 74-80 Gy in 2 Gy fractions, resulting in an overall treatment time of 7-8 weeks.~     The sensitivity of different tissues to fractionation changes can be quantified through the~     α/β ratio in the linear-quadratic model. Dose-response analysis of PC patients treated with~     both external beam RT and brachytherapy has led to the hypothesis that the α/β ratio of PC is~     lower than for most other tumors and approaches a value characteristic of late responding~     tissues. Values between 1.2 and 3.9 Gy have been calculated. If the α/β ratio of PC is indeed~     low, then hypofractionating RT treatments can theoretically maintain high bioequivalent tumor~     doses, shorten overall treatment time and decrease late toxicities.The advantages in terms of~     patient convenience and treatment cost are obvious. There is level I evidence that shows that~     hypofractionated radiotherapy schedules have at least equivalent biochemical outcome with~     only a small increase in acute but not late toxicity when compared to conventional~     fractionation RT schedules.~      Results on different hypofractionation schedules have been reported, however the optimal~     hypofractionation is not clear so far. In this randomised trial we would like to compare 2~     different radiotherapyschedules: 16 fractions à rato of 4 fractions a week versus 25~     fractions à rato of 5 fractions a week. The incidence on acute toxicity and early late~     toxicity (i.e. within 2 year post radiotherapy) and the impact on quality of life will be~     registrated and compared. The study will be performed in 2 stages. For stage 1, sample size~     was calculated to rule out an upper limit of 40% of patients with RTOG grade 2 or worse bowel~     (GI) complications with an expected rate of 25%, based on a one-stage Fleming-A'Hern design.~     A power of 83.0% (alpha level 0.038 one-sided) was obtained when including 72 patients per~     group (144 patients in total). If 22 or more patients out of 72 had grade 2 or worse GI~     complications, then the study arm was to be rejected. To allow for a dropout of 10%, 160~     patients were included in stage 1. Sample size for stage 2 was calculated analogously~     allowing ruling out an upper limit of 35% of patients with RTOG grade 2 or worse GI~     complications with an expected rate of 25%. When including 155 patients per group (310 in~     total) a power of 85.7% (alpha level 0.049 one-sided) was obtained. If 45 or more patients~     out of 155 had grade 2 or worse GI complications, then the study arm was to be rejected. The~     sample size for stage 1 and stage 2 combined was set at 346 (173 per group), with a 10%~     allowance for dropout.~   "
125728|NCT01921790|"~     The purpose of this study is to evaluate the efficacy and safety of avastin combined with~     gemcitabine, oxaliplatin, pegaspargase and dexamethasone(Avastin+ GemAOD) as first-line~     treatment in patients with untreated natural killer(NK)/T cell lymphoma~   "
125729|NCT01921777|"~     To investigate and compare the effects of Traumeel®S tablets versus placebo on recovery and~     inflammatory immune response over a period of 72 hours after a second bout of strenuous~     concentric exercise on bicycle (exercise #2).~   "
125730|NCT01921764|"~     The prevalence and consequences of musculoskeletal pain is considerable among healthcare~     workers, allegedly due to high physical work demands of healthcare work. Previous studies~     have shown promising results of physical exercise for relieving pain among different~     occupational groups, but the question remains whether such physical exercise should be~     performed at the workplace or in the private sphere at home. Performing physical exercise at~     the workplace together with colleagues may be more motivating for some employees and thus~     increase compliance. On the other hand, physical exercise at the workplace may be costly for~     the employers in terms of time spend. Thus, relevant ground exists to compare the efficacy of~     workplace- versus home-based training on musculoskeletal pain. This study investigates the~     effect of workplace-based versus home-based physical exercise on musculoskeletal pain among~     healthcare workers.~      The main hypothesis is that physical exercise at the workplace for 10 weeks compared with~     physical exercise at home results in reduced musculoskeletal pain among healthcare workers.~   "
125731|NCT01921751|"~     This randomized phase II trial studies how well high or standard intensity radiochemotherapy~     after gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation~     (nab-paclitaxel) work compared with gemcitabine hydrochloride and nab-paclitaxel alone in~     treating patients with pancreatic cancer that cannot be removed by surgery. Drugs used in~     chemotherapy, such as gemcitabine hydrochloride and nab-paclitaxel, work in different ways to~     stop the growth of tumor cells, either by killing the cells, by stopping them from dividing~     or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor~     cells. Drugs, such as capecitabine, may make tumor cells more sensitive to radiation therapy.~     Giving radiation therapy in different ways and adding chemotherapy may kill more tumor cells.~     It is not yet known whether high intensity radiochemotherapy after gemcitabine hydrochloride~     and nab-paclitaxel is more effective than standard intensity radiochemotherapy after~     gemcitabine hydrochloride and nab-paclitaxel or gemcitabine hydrochloride and nab-paclitaxel~     alone in treating pancreatic cancer.~   "
125733|NCT01921725|"~     The research uses hydrophilic-based dressing (KoCarbonTM) which is developed by Medical~     Technology Company Limited (Bio-medical Carbon Technology; BCT) to investigate the wound~     healing effects of activated-carbon-fiber-based wound dressing on different types of~     wounds.The dressing is composed by three layers. The first layer is a material of~     polyethylene terephthalate (PET) weave which is great breathable; Second layer, the activated~     carbon fiber cloth, is as the absorption of excess tissue fluid, bacteria and contaminations.~     It reduces the smell of wound and restrains the development of bacteria. In addition,~     activated carbon has features of far-infrared and anion, which promote blood circulation,~     speed up metabolism and shorten the time of wound healing. The third layer is a polyethlene~     (PE) film, which touches the wound surface and provides the anti-adhesion effects.~      The aim of this study is to investigate how the application of the dressing affects the wound~     healing conditions on four different types of wounds, including general traumatic wounds,~     elective surgery wound, diabetes foot ulcer (level 2) and chronic wounds. Due to the~     characteristics of great fluid absorption and far-infrared features, the hydrophilic-based~     dressing (KoCarbonTM) is expected to work perfectly on improving the wound repair conditions.~   "
125734|NCT01921712|"~     The purpose of this study is to assess the safety and tolerability of PUR0200. In addition,~     the study will look at the blood levels of different doses of PUR0200 and their affect on~     lung function in COPD patients.~   "
125735|NCT01921699|"~     Macrophages are derived from monocytes recruited to the tumor site and stimulated by specific~     chemokines secreted by tumor cells. These tumor associated macrophages (TAMs) have been~     postulated as being involved in the progression of cancer.~      Based on our preliminary findings and on published data we hypothesized that~     macrophage-induced chemoresistance (MIC) can promote survival of pancreatic carcinoma cells~     during chemotherapy.~      The overall goal of this study is to evaluate the mechanism of MIC in an in-vitro model of~     Pancreatic ductal adenocarcinoma (PDA).~      methods:~        1. The human PDA cell line Panc1 will be grown in suitable conditions.~        2. Macrophages will be produced by incubating mononuclear cells from the blood of healthy~          donors in medium with M-CSF for 7 days.~        3. TAMs will be generated by culturing these macrophages with tumor-culture conditioning~          medium (TCCM) of PDA Cells for an additional 72 hours.~        4. Human pancreatic cells (PANC1) will be treated with gemcitabine following exposure to~          macrophages CM.~        5. Cell proliferation will be quantified by light microscopy and by an XTT Cell~          Proliferation Assay Kit.~   "
125736|NCT01921686|"~     The purpose of this project is to learn more about a new and promising way to diagnose acid~     reflux disease using a very high-powered microscope. This special microscope provides much~     finer detail than typical microscopes previously used for diagnosing reflux, and may help~     doctors to better identify children with acid reflux.~   "
125737|NCT01921673|"~     Docetaxel is currently one of standard second-line therapy in patients with gastric cancer.~     As angiogenesis and FGFR pathway has been suggested to be associated with gastric cancer,~     dovitinib, dual VEGFR and FGFR inhibitor, may have the potential to improve the outcomes of~     patients with gastric cancer. Therefore, we investigated the combination regimen of docetaxel~     and dovitinib.~   "
125738|NCT01921660|"~     Use of dipole density mapping to identify activation in complex supraventricular tachycardias~   "
125739|NCT01921647|"~     The objective of this study is not only to explore pharmacokinetic interaction after single~     oral administration but also pharmacodynamics interaction after multiple oral administration~     of YH4808, amoxicillin and clarithromycin each separately versus coadministration of YH4808,~     amoxicillin and clarithromycin in healthy volunteers~   "
125740|NCT01921634|"~     There is great variation seen in the incidence of appendiceal endometriosis. The variation is~     most likely multifactorial, but method with which the specimen is examined may play a role.~     If analysis using more cuts is used, appendiceal endometriosis may be diagnosed at a higher~     rate.~   "
125741|NCT01921621|"~     This study examines in a prospective, randomized and blinded study design the impact of a~     proficiency based training methodology on the acquisition of arthroscopic surgical skills~     employing both a dry shoulder simulator model, and cadaver specimens for the demonstration of~     surgical skill proficiency.~   "
125742|NCT01921608|"~     It is well known from a range of observational and epidemiological studies that the lifetime~     risk of acquiring HIV among males can be significantly reduced via circumcision. Numerous~     papers on the topic were published in the past two decades to elevate HIV prevention~     awareness, especially in sub-Saharan countries.~      Rwanda has a national plan to offer a voluntary circumcision program to 2 million adult men~     in 2 years as part of a comprehensive HIV prevention package. To achieve this goal, the~     government is continuing to study the PrePex™ device, developed to enable rapid adult male~     circumcision in resource limited settings.~      In February 2012, Rwanda has received WHO recommendation to scale up Adult Male male~     circumcision (MC) using the PrePex device. Based on WHO recommendation (Use of devices for~     adult male circumcision in public health HIV prevention programs: Conclusions of the~     Technical Advisory Group on Innovations in Male Circumcision, March 2012, WHO/HIV/2012.7),~     which recommended that the phased implementation include an active surveillance of the first~     1000 clients to identify and record all adverse events and side-effects based on standardized~     definitions. The active surveillance may change to passive surveillance after the first 1000~     clients, if the incidence of events is reassuringly low, as determined by independent review.~   "
125743|NCT01921595|"~     The purpose of study is to compare the effect of coagulation profile in patients receiving~     intraoperative balanced salt colloid undergoing spinal cord tumor surgery.~   "
125744|NCT01921582|"~     The purpose of this study is to determine whether methylphenidate is effective in the~     treatment of binge eating disorder, in a randomized controlled trial extended release~     methylphenidate versus cognitive behavioral therapy for binge eating disorder in overweight~     or obese adult females.~   "
125745|NCT01921569|"~     The purpose of this study is to determine whether micronized dehydrated human amniotic~     membrane (dHACM) suspension is more effective in reducing inflammation than conservative~     measures alone when used to treat acute/early lateral epicondylitis.~   "
125825|NCT01920529|"~     Regular aerobic physical activity in short-term moderate asthma and severe:~        -  Reduce the levels of inflammatory mediators~        -  Improves functional capacity~        -  Improves Quality of Life~        -  Improved lung function~        -  Reduces the sensation of dyspnea~        -  Improves symptoms scores and medication use~   "
125746|NCT01921556|"~     Background The Swiss health ministry launched a national quality program QualiCCare in 2011~     to improve healthcare for patients with COPD.~      The aim of this study is to determine whether participation in the COPD quality initiative~     (QualiCCare) improves adherence to recommended clinical processes and shows impact on~     patients COPD care and on quality of life in patients with COPD.~   "
125747|NCT01921543|"~     The main aim of this trial was to investigate whether patients suffering from treatment~     refractory- Major Depressive Disorder (MDD) can benefit from DBS (Deep Brain Stimulation) in~     the brain areas known as inferior thalamic peduncle (ITP) and/or Capsula Interna/Bed nucleus~     of the stria terminalis (CI/BNST)~   "
125748|NCT01921530|"~     Degenerative spondylolisthesis describes the slip of one spinal segment relative to the~     adjacent segment. It is usually associated with spinal stenosis (which limits one's ability~     to walk and stand) and is the most common indication for surgery in adults over age 65 years.~     A variety of surgical techniques are available; the most common are the Posterolateral~     Instrumented Fusion (PLF), and Interbody Fusion (IF) including Posterolateral Interbody~     Fusion (PLIF), and Transforaminal Interbody fusion (TLIF). IF uses a cage that is placed~     within the cleaned out disc space between the vertebral bodies being fused. Although this~     approach achieves a good fusion rate and deformity correction it is associated with a higher~     surgical cost and potential intra-operative complication rate. What is more, no consensus~     exists as to whether IF provides better patient rated functional outcome and quality of life.~     If the advantages of IF do not translate into superior patient rated outcomes, then the~     risk-benefit ratio would be tipped in favor of PLF. The purpose of this study is to determine~     if IF is equivalent to PLF for the treatment of degenerative spondylolisthesis. The~     investigators will conduct a prospective randomized control trial comparing these two~     procedures. Our primary outcome measure will be the Oswestry Disability Index, which~     evaluates spinal pain and function.~   "
125749|NCT01921517|"~     The response to a daily 10 minute session of low-magnitude mechanical stimulation (LMMS) on~     bone in 100 postmenopausal women ages 45-65 years will be evaluated at baseline and 12 months~     using high-resolution magnetic resonance (MR) imaging. Subjects will be assigned to an active~     platform that produces vibrations or to a placebo platform that produces no vibrations.~      The investigators propose to evaluate the hypothesis that LMMS applied to postmenopausal~     women ages 45-65 improves the mechanical integrity of bone while lowering marrow adiposity.~        1. The investigators will optimize an integrated imaging protocol for high-resolution~          structural MR imaging of the distal tibia and spectroscopic imaging-based quantification~          of bone marrow composition in the lumbar vertebrae.~        2. The investigators will further develop and validate micro-finite-element (FE) analysis~          for quantitative assessment of trabecular and cortical bone stiffness and failure load~          from high-resolution MR images of the distal tibia.~        3. The investigators will apply the methodology of Aims 1 and 2 (above) in a~          double-blinded, randomized, placebo-controlled study to a cohort of 100 healthy~          postmenopausal women in the age range of 45-65 years, studied at baseline and 12 months~          after having been subjected to 10 minutes daily of either 30 Hz/0.3g stimulation or~          placebo treatment, monitored rigorously via electronic feedback.~   "
125750|NCT01921504|"~     The aim of the study is to investigate the effect of acupuncture treatment on functional~     dyspepsia.~   "
125751|NCT01921491|"~     The purpose of this study is to determine whether dehydrated human amnion/chorion membrane~     (dHACM) is more effective than another commercially available product or conservative~     measures alone when used to treat diabetic foot ulcers (DFUs).~   "
125752|NCT01921478|"~     This retrospective, multi-centre, observational study will assess the daily practice patterns~     and outcomes of the management of rheumatoid arthritis in patients treated with~     RoActemra/Actemra (tocilizumab). No actual patient will be enrolled in this study; data will~     be collected from medical records.~   "
125753|NCT01921465|"~     The purpose of the study is to evaluate whether outpatient cesarean section can be performed~     in multiparous women without significant decrease in the parents' sense of security .~   "
125754|NCT01921452|"~     This is a Phase 4, single-center, open-label, interventional study, wherein all enrolled~     subjects will be tested for Thyroid Stimulating Hormone (TSH) by using the quantitative and~     the qualitative Point-of-Care (POC) TSH test kits and the third generation TSH test kit at~     the same time.~   "
125755|NCT01921439|"~     The long-term goal is to improve the quality of life of children and their parents who smoke~     tobacco by facilitating parental smoking cessation in a way that is easy to administer yet~     effective. We aim to accomplish this goal by administering an interactive computer-based~     program that will facilitate motivation and readiness to engage in smoking cessation by~     providing personalized feedback about the financial and health effects of the parent's~     smoking. We will compare the changes in motivation and readiness to quit smoking after the~     parent has taken the computer-based program and compare them to the changes in motivation and~     readiness to quit in parents who receive only information about the Oklahoma Tobacco~     Helpline. We will also measure salivary cotinine levels in both parents and children, to~     objectively measure changes in smoking habits and secondhand smoke exposure. Our hypothesis~     is that our computer-based program will cause a greater increase in motivation and confidence~     to quit smoking in the group that receives the customized feedback than the group that~     receives only information about the Tobacco Helpline. We also predict that both parent and~     child cotinine levels will show a greater decrease in the group randomized to receive~     personalized feedback.~   "
125756|NCT01921426|"~     The purpose of this study is to determine the safety, tolerability, and the highest dose of~     GC4419 that can be given to patients with squamous cell cancer of the head and neck who are~     receiving standard radiation therapy and chemotherapy. This study will also evaluate GC4419~     for the following:~        -  Effect on the incidence and severity of radiation induced oral mucositis;~        -  Effect on the response rate of squamous cell cancer of the head and neck who are~          receiving radiation therapy and chemotherapy;~        -  Total concentrations of GC4419 that can be achieved in the blood;~        -  Changes in proteins and genetics associated with oral mucositis;~        -  Impact on delayed toxicities of radiation (dry mouth and reduced ability to fully open~          the mouth);~        -  Observe changes in genetic and molecular markers of oral mucositis;~        -  Observe the usage of extra health resources (e.g., unplanned ER visits, feeding tube~          use, etc.) of study patients;~        -  Assess the overall quality of life in study patients with oral mucositis.~   "
125757|NCT01921413|"~     The purpose of this study is to evaluate the clinical performance of the one-step Fyodor~     Urine Malaria Test (UMT), to determine its accuracy (sensitivity and specificity) for the~     diagnosis of Plasmodium falciparum malaria in febrile patients. A total of 1500 properly~     consented children and adults presenting with fever (axillary temperature ≥37.5°C) or history~     of fever in the last 48 hours (Group 1), 250 apparently healthy individuals (Control, Group~     2), and 50 patients with Schistosoma hematobium and Rheumatoid arthritis (Group 3), will be~     recruited. Matched urine and fingerprick (capillary) blood samples will be collected and~     tested using the UMT and, Binax NOW® malaria rapid diagnostic test (blood test) and thick~     smear microscopy, respectively. The overall agreement of the UMT results to the Binax NOW~     analysis and thick smear microscopy will be used to establish UMT sensitivity and~     specificity.~   "
125758|NCT01921400|"~     To evaluate for the presence of HCV Core protein, HCV RNA and SPP in the placenta and fetal~     membranes using paraffin-embedded sections and post-delivery specimens respectively. In~     parallel, we will assess placental tissue for evidence of HCV infection using a novel in situ~     hybridization technique and translate our in vitro findings to these in vivo samples.~      Our overall hypothesis is that cytotrophoblasts at the maternal-fetal interface within the~     placenta serve as a barrier that must be crossed during vertical transmission and that~     cytotrophoblasts are permissive to HCV at a low level that may be enhanced under certain~     conditions. By comparing the regulation of key steps in the intracellular life cycle of HCV~     in cytotrophoblasts to highly permissive hepatocytes, significant differences in HCV~     regulation should be revealed.~      Based on our preliminary data, our working hypothesis is that HCV Core protein is~     differentially processed in cytotrophoblasts compared to hepatocytes.~   "
125759|NCT01921387|"~     This phase I/II trial studies the side effects and the best dose of radiolabeled monoclonal~     antibody when given together with combination chemotherapy before stem cell transplant and to~     see how well it works in treating patients with high-risk lymphoid malignancies. Radiolabeled~     monoclonal antibodies, such as yttrium Y 90 anti-CD45 monoclonal antibody BC8, can find~     cancer cells and carry cancer-killing substances to them without harming normal cells. Giving~     chemotherapy before a stem transplant stops the growth of cancer cells by stopping them from~     dividing or killing them. Stem cells collected from the patient's blood are then returned to~     the patient to replace the blood-forming cells that were destroyed by the radiolabeled~     monoclonal antibody and chemotherapy.~   "
125760|NCT01921374|"~     The incidence of Duchenne Muscular Dystrophy (DMD) is approximately 1 in 3.500 male newborns.~     During its progression there is loss of mobility, swallowing difficulties and a significant~     reduction in respiratory capacity. Due to the severity and consequences, is inevitable the~     need for a caregiver, that normally rely the mother.~   "
125761|NCT01921361|"~     The purpose of this study to compare the efficacy of intravenous or intrathecal~     dexmedetomidine on the incidence of shivering on patients who scheduled spinal anesthesia for~     elective surgery.~   "
125762|NCT01921348|"~     We hypothesize that ear acupressure will be effective in treating seasonal allergic rhinitis~     by changing the immune parameters and the psychological impact factors are associated with~     ear acupressure treatment outcome.~   "
125763|NCT01921335|"~     The purpose of this study is to test the safety of different doses of ARRY-380 in combination~     with trastuzumab. Trastuzumab is an FDA approved drug for the treatment of HER2 metastatic~     breast cancer. However, the combination of ARRY-380 and trastuzumab has not yet been tested.~     Both agents block the HER2 receptor, which is thought to be overactive in HER2-positive~     breast cancer. It is thought that ARRY-380 and trastuzumab might work together because they~     attach to different parts of the HER2 receptor and prevent it from functioning. Because HER2~     positive breast cancer contains high levels of HER2 receptor, but normal cells in your body~     generally do not, the drugs may be able to target the cancer cells. In addition, in~     laboratory studies, ARRY-380 appears to have some penetration into the brain.~   "
125764|NCT01921322|"~     This is a prospective, randomized (open label), multi-center and post-market study. The study~     is to compare effectiveness of sensor-augmented pump (SAP) therapy versus multiple daily~     injection (MDI) therapy in hospitalized patients with insulin treating type 2 diabetes in~     China~   "
125765|NCT01921309|"~     To demonstrate the safety and effectiveness of the Trinity™ BIOLOX delta™ Ceramic-on-Ceramic~     Total Hip System in comparison to the Trinity™ Acetabular Hip System,which is FDA cleared for~     use in the U.S. The comparison will be based upon clinical success at the Month 24 endpoint.~   "
125766|NCT01921296|"~     Many women with breast cancer who are treated with aromatase inhibitor medications develop~     difficulty sleeping and fatigue during treatment. Some examples of aromatase inhibitor~     medications include anastrozole (Arimidex), exemestane (Aromasin), and letrozole (Femara).~     Frequently, sleeping pills do not work very well to improve sleep. Cyclobenzaprine (Flexeril)~     is a medication that was originally developed to treat muscle spasms. It may also improve~     sleep in patients with chronic pain disorders, such as fibromyalgia. In this study we are~     testing to see if cyclobenzaprine at bedtime will help improve sleep in women treated with~     aromatase inhibitors.~   "
125767|NCT01921283|"~     There are clinical usefulness issues associated with bispectral index (BIS) for sedation of~     endoscopic submucosal dissection (ESD). However, the clinical usefulness of BIS for deep~     sedation is incompletely described. The purpose of this study is to show that BIS-guided~     sedation is safe and useful clinically and may provide stable sedation status to physicians~     and patients.~   "
125768|NCT01921270|"~     The purpose of this study is to study the efficacy and safety of AbobotulinumtoxinA (Dysport)~     for use in Oromandibular Dystonia (OMD).~   "
125769|NCT01921257|"~     Study to Assess the Safety of Cat-PAD in Cat Allergic Paediatric Subjects~   "
125795|NCT01920919|"~     This trial examines whether low grade suppression of the initial inflammatory process of~     sarcoidosis by intervention with low-dose dexamethasone therapy achieves significant~     alleviation of (sub-)acute symptoms, improvement in quality of life, increase in work~     productivity, and whether this intervention prevents disease progression and reduces total~     health-care costs.~   "
125853|NCT01920165|"~     The purpose of this study is to investigate whether there has been a change in the number of~     hospital admissions for respiratory tract infections among children following the July 2007~     introduction of a ban on smoking in public places in England.~   "
125770|NCT01921244|"~     Children with Autism Spectrum Disorder (ASD) commonly experience behavioral challenges that~     may be improved with pharmacotherapy, including difficulties with sleep, attention,~     hyperactivity, impulsivity, anxiety, obsessive-compulsive behavior, mood swings, self-injury,~     and aggression. While 34-58% of children with ASD take medication for such behaviors, there~     is wide practice variation nationally and a lack of evidence to support the use of most~     commonly prescribed agents. Complex clinical situations such as this where there is no clear~     best choice regarding which behaviors to target and which medications to use lend~     themselves well to the use of a Shared Decision Making (SDM) tool to ensure that~     well-informed parent preferences shape every treatment plan.~      The primary goal of this study is to modify a previously published decision aid about use of~     medication to manage challenging behaviors in children with autism to make it easy to~     implement in practice and then evaluate this version in terms of proximal decisional outcomes~     and parent/child outcomes 3 months later. Providers in a Developmental-Behavioral Pediatric~     clinic will be enrolled and randomly allocated to intervention or control (treatment as~     usual) groups. Initially, providers randomized to the intervention group will test and refine~     the modified intervention. Once the intervention is finalized, eligible patients of~     participating providers will be enrolled in the randomized controlled trial to test the~     efficacy of the intervention. Following the trial, control group providers will be crossed~     over and receive the intervention. Both proximal decisional outcomes (e.g. parent decisional~     conflict, provider amount of SDM, parent knowledge of treatment options) and outcomes 3~     months later (e.g. parenting stress, decisional conflict, and change in child behavioral~     symptoms) will be assessed.~      Approximately 10 providers and 240 of their patients with autism will be included in the~     study. Chart reviews, parental surveys, and recordings of provider-parent-patient~     interactions during the index visit will be collected at baseline (prior to physician~     allocation), during the intervention trial, and after the control group has crossed over.~     Between- and within-group analyses will examine factors associated with parental decisional~     conflict and whether the intervention produces significant improvements in outcomes over and~     above typical autism care. Analyses will include multiple linear regression modeling and~     general linear models / repeated measure models, accounting for data clustered by provider.~   "
125771|NCT01921231|"~     Selective spinal anesthesia is widely used for ambulatory surgery. Unilateral spinal~     anesthesia is a suitable option for ambulatory anesthesia as it is efficient and effective.~     Lidocaine has been the well-known choice for this procedure. However, it is associated to~     transient neurologic symptoms (TNS). Different anesthetic strategies for this procedure have~     been performed, for example, the use of small doses of long-acting agents and the use of~     additives such as opioids. The ideal local anesthetic should be lidocaine-like without risk~     of transient neurologic symptoms. We design and plan a randomised clinical trial to show if~     hyperbaric prilocaine 2% would be an alternative.~   "
125772|NCT01921218|"~     The purpose of this study is to test the safety and effectiveness of belatacept (Nulojix®) in~     preventing antibody formation in patients with chronic failing kidney transplants. This study~     is a randomized study of first-time kidney transplant patients who have worsening kidney~     function and biopsy proven grade 2 or 3 interstitial fibrosis/tubular atrophy (IF/TA).~     Patients must be eligible to get a second transplant. They must have completed or be actively~     undergoing evaluation for re-listing for a second transplant. Patients will be randomized to~     either convert to belatacept or continue on calcineurin inhibitor-based therapy.~   "
125773|NCT01921205|"~     Study to evaluate the efficacy of Lacosamide (LCM) administered in addition to 1 to ≤3 other~     Anti-Epileptic Drugs in subjects with epilepsy ≥4 years to <17 years of age who currently~     have uncontrolled partial onset seizures.~   "
125774|NCT01921192|"~     Homocysteine, a well-known inducer of vascular endothelial cell damage has been associated~     with extracellular matrix changes. Many studies demonstrated that high levels of this~     aminoacid in diabetic patients increases significantly the risk of the development of this~     pathology. This study has been undertaken to investigate the role of homocysteine and its~     cofactors (folic acid, vitamin B6 and B12) during the progression of the diabetic~     retinopathy.~   "
125775|NCT01921179|"~     One of the most pressing concerns within the VA currently is the provision of interventions~     that address the cognitive as well as emotional problems faced by Veterans with concurrent~     mild TBI and PTSD. One purpose of this study is to learn more about how PTSD and mild brain~     injury influences how people think, act, and feel. This may include how people pay attention,~     keep information in memory, organize plans for achieving important goals, and manage stress.~     Another purpose of this research is to learn more about the effects of cognitive training on~     the thinking, behavior, and emotions of individuals with PTSD and mild brain injury - both in~     the short- and long-term. With this research, the investigators hope to better understand and~     treat cognitive and emotional difficulties that can occur due to PTSD and mild brain injury.~   "
125776|NCT01921166|"~     The purpose of the study is (A) to determine if the following novel approach improves the~     live birth rate with In-Vitro Fertilization (IVF) for women with a poor prognosis due to~     diminished ovarian reserve:~        -  ovarian stimulation with medications that are effective in women with diminished ovarian~          reserve but adversely affect the endometrium~        -  oocyte retrieval and vitrification~        -  fertilization and embryo transfer in a subsequent cycle with controlled endometrial~          preparation B) To determine the optimal stimulation protocol for women with diminished~          ovarian reserve incorporating oocyte vitrification~      Women who are not eligible to participate in the Carolinas Medical Center (CMC) Assisted~     Reproductive Therapy program because of an extremely poor prognosis will be recruited for a~     prospective, randomized, open-label study to determine if a novel approach improves the live~     birth rate with traditional IVF poor prognosis stimulation protocols. The novel approach~     will incorporate one of two protocols utilizing medications that provide maximal ovarian~     stimulation but have a temporary detrimental fertility-reducing effect on the endometrium. If~     ovarian stimulation is adequate, oocyte retrieval will be performed and viable oocytes~     vitrified (stored in a glass-like state in liquid nitrogen). At a later time, oocyte~     warming and fertilization will be performed in a subsequent cycle, in which the endometrium~     has been prepared.~      Key points include:~        -  Randomization to one of two ovarian stimulation protocols that have been shown to have a~          detrimental effect on the endometrium, and therefore are rarely used in a fresh IVF~          cycle~        -  Oocyte vitrification is considered to be an investigational procedure by the American~          Society of Reproductive Medicine (ASRM), and should only be performed under the~          supervision of an IRB. With oocyte vitrification, ovarian stimulation and oocyte~          retrieval can unlinked from embryo transfer, allowing embryo transfer to occur in a~          more optimal environment~        -  Endometrial preparation is routine for frozen embryo transfer~   "
125777|NCT01921153|"~     The primary objective of this study is to test effectiveness of an environmental intervention~     designed to encourage healthy food intake during meals. It is hypothesized that fruit,~     vegetable, whole grain, lean protein, and low-fat dairy consumption will increase during the~     intervention. It is also hypothesized that nutrition knowledge, attitudes, and behaviors will~     change as a result of the intervention. The findings from this study will provide insight~     into the applicability of this intervention in military dining facilities.~   "
125778|NCT01921140|"~     This is a 3 part study for patients with solid tumours. The purpose of Part A is to measure~     the amount of olaparib or its breakdown products in the bloodstream for up to 72 hours after~     eating and the effect of olaparib on QT interval following a single oral dose of olaparib~     tablets. Part B will determine the effect of olaparib on the QT interval following multiple~     oral dosing. Part C will allow patients continued access to olaparib tablets and will provide~     additional safety data collection.~   "
125779|NCT01921127|"~     This study is intended to evaluate treatment effectiveness of BFC compared to FSC in COPD~     patients new to ICS/LABA combination therapy.~   "
125780|NCT01921114|"~     The main purpose of this study is to confirm whether the AngioDynamics BioFlo™ Peripherally~     Inserted Central Catheter (PICC) is associated with less formation of blood clots compared to~     another commercially available PICC.~   "
125781|NCT01921101|"~     The investigators propose a prospective randomized clinical trail to evaluate the impact of~     intensive medical nutrition therapy (IMNT) in patients with acute respiratory distress~     syndrome (ARDS) or acute lung injury (ALI) on short and long-term outcomes. Participant's (N~     = 200) will be randomized to receive either standard care (SC e.g. ad lib feeding of standard~     food) or IMNT provided early as enteral nutrition (EN) and continued as intensive diet~     therapy tailored to maximize oral intake until hospital discharge. Primary outcomes evaluated~     include infections while hospitalized, immune parameters (CD4 and CD8 cells, serum IL-10 and~     leptin levels, numbers of T regulatory cells and markers for T cell anergy), days on~     mechanical ventilation, in the ICU and hospital , and changes in fat free mass(measured by~     dual energy x-ray absorptiometry), weight, muscular weakness (measured as hand grip~     strength), fatigue (measured as distanced traveled in 6-minute walk) and pulmonary function.~   "
125782|NCT01921088|"~     The purpose of this study is to determine the potential efficacy of real-time functional~     magnetic resonance imaging neurofeedback (RT-fMRI-NF) in regulating brain activity and~     psychophysiological functions.~   "
125783|NCT01921075|"~     The main goal of the present study was to provide a technical basis for future studies~     assessing the role of cardiac lipids. More specifically, non-invasive MR-Spectroscopy (MRS)~     techniques will be used in this study to:~        1. assess the methodological reproducibility of MRS-measurements of cardiac lipids in~          humans~        2. investigate physiological variations of cardiac lipids by measuring day-to-day changes~          under identical conditions~        3. determining diurnal variations of cardiac lipids in humans~   "
125784|NCT01921062|"~     The aim of this study is to determine whether motor imagery training during the~     immobilisation period in patients with a distal radius fracture, results in an improved~     functional outcome compared to patients who do not perform motor imagery.~   "
125785|NCT01921049|"~     Patients undergoing major procedures in oral and maxillofacial surgery more often develop a~     systemic inflammatory response syndrome (SIRS) in the first days of postoperative critical~     care therapy than patients with a comparable major surgery in other regions. The reasons for~     this finding are unknown and have not been studied in depth so far. We hypothesize that~     surgical trauma in this region might activate pro-inflammatory pathways. By examining the~     proteome of patients at different stages (prior to the surgery, at ICU admission, on the~     second postoperative day and when SIRS has ended clinically), we aim to identify the involved~     pro-inflammatory pathways and identify possible target proteins that might be clues to~     modification of postoperative SIRS in the future.~   "
125786|NCT01921036|"~     Seventy patients in cardiac rehabilitation with maximal exercise capacity less than 1.4 watt~     per kilogram bodyweight will be randomized 1:1 into either an intervention training (IN)~     group or usual care (UC). The IN patients will perform supervised endurance and resistance~     exercise for approximately 90 minutes once a week and traditional cardiac rehabilitation~     (TCR) once a week; the UC patients will perform TCR twice a week. The intervention is planned~     for six months with a follow-up of a further six months. The primary investigation is~     differences between IN and UC with regard to changes in exercise capacity (max watt/kgBW).~   "
125787|NCT01921023|"~     This clinical investigation is being undertaken to examine the performance of the CE marked~     Proxima System - a patient attached blood gas analyser.~      The study forms an element of the Post Market surveillance plan for the Proxima system and~     will also generate method comparison data to allow Sphere Medical to submit the Proxima for~     FDA regulatory clearance.~   "
125788|NCT01921010|"~     The combination of HDL-C elevation, lowering of triglycerides and further LDL-C reduction~     accomplished by the addition of niacin to statin medication would improve endothelial~     function as compared to LDL-C reduction alone in patients with and without coronary artery~     disease and the combination of low HDL-C/high triglycerides.~      The combination of lipid lowering therapy would have beneficial effects on markers of~     inflammation. These benefits would be particularly evident in women.~   "
125789|NCT01920997|"~     This study will recruit 50 healthy women with normal menstrual cycles aged 40-50, to~     investigate the expression of their NEI network and urine metabolomics.~   "
125790|NCT01920984|"~     To determine the vitreous levels of fractalkine, cysteine-rich 61 (Cyr61), and VEGF in~     patients with PDR. Verifying that it is greater to that found in non-diabetic patients with~     different non-angiogenetic diseases.~   "
125791|NCT01920971|"~     To investigate the effects of short-term and medium-term monochromatic infrared energy~     therapy on patients with chronic low back pain (LBP) according to the International~     Classification of Functioning, Disability and Health.~   "
125792|NCT01920958|"~     The purpose of this study is to describe effectiveness and reliability of TachoSil® in lymph~     sealing after lymphadenectomy.~   "
125793|NCT01920945|"~     The purpose of this study is to evaluate the effect of BOTOX® (OnabotulinumtoxinA) on the~     number of headache days in patients with New Daily Persistent Headache (NDPH). NDPH is a~     benign form of chronic daily headache that comes in two forms: one that resolves on its own~     after months to years, or one that is difficult to treat and does not respond to preventive~     or abortive medications. Some patients experience migrainous features such as nausea,~     vomiting, photophobia, or phonophobia. BOTOX®, a treatment approved for chronic migraine,~     will be injected into specific muscles of the head and neck area by your study doctor, to~     evaluate its effectiveness in reducing or relieving NDPH days or severity. BOTOX has not been~     approved for NDPH and this is the first time it will be used for treatment of NDPH. All~     participants in this study will only receive BOTOX® and no other study drug.~   "
125794|NCT01920932|"~     This pilot phase II trial studies how well giving brentuximab vedotin, combination~     chemotherapy, and radiation therapy works in treating younger patients with stage IIB, IIIB~     or IV Hodgkin lymphoma. Monoclonal antibodies, such as brentuximab vedotin, can block cancer~     growth in different ways. Some block the ability of cancer to grow and spread. Others find~     cancer cells and help kill them or carry cancer killing substances to them. Drugs used in~     chemotherapy, such as etoposide, prednisone, doxorubicin hydrochloride, cyclophosphamide, and~     dacarbazine, work in different ways to stop the growth of cancer cells, either by killing the~     cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill~     cancer cells. Giving brentuximab vedotin with combination chemotherapy may kill more cancer~     cells and reduce the need for radiation therapy.~   "
125796|NCT01920906|"~     Psoriasis is a chronic, debilitating skin disorder with an estimated prevalence of 2%.~     Psoriatic skin lesions start with initial pinhead-sized macules and then coalesce into~     plaques of varying sizes. Despite the great strides in the studies for psoriasis, it is still~     unclear why psoriatic skin lesions start with small macules and then spread peripherally.~      To study peripheral spreading of psoriasis, investigators plan to study small plaque~     psoriasis in comparison to large plaque psoriasis in the Korean population. Large plaque~     psoriasis is the most common form of psoriasis, seen in approximately 90% of all psoriasis~     participants. Large psoriatic plaques are >5 cm in size and localize to the extensor aspects~     of the elbows, knees, scalp, and genital area. On the other hand, small plaque psoriasis is~     the common or typical form of psoriasis that occurs particularly in Korea and other Asian~     countries. Korean small plaque psoriasis, even when chronic, remains <2 cm in size and is~     widely distributed on the upper trunk and proximal extremities.~      Investigators hypothesize that the expression of immune-related genes are different between~     small and large plaque psoriasis. The study of a genetically homogeneous cohort,~     characterized by the relatively high prevalence of small plaque psoriasis in the Korean~     population, may filter out spurious signals while allowing for significant associations to~     emerge from a relatively low number of participants.~      By comparing small and large plaque psoriasis, it is expected this study could lead to new~     understandings of the mechanisms involved in spreading of psoriatic plaques and provide new~     insights into psoriasis development.~   "
125797|NCT01920893|"~     Primary Objective:~      To evaluate the efficacy of dupilumab (SAR231893/REGN668) in the treatment of bilateral Nasal~     Polyposis (NP) by assessment of the endoscopic nasal polyp score (NPS) in comparison to~     placebo.~      Secondary Objectives:~      To evaluate effect of dupilumab with regards to:~        -  symptoms of sinusitis,~        -  sinus computed tomography (CT) scan,~        -  NPS in the sub-group of participants with co-morbid asthma,~        -  Safety and tolerability.~   "
125798|NCT01920880|"~     Rationale: Chronic abdominal pain is a frequently occurring condition. Although hardly ever~     considered, the abdominal wall is the primary cause in 10-30% of cases. Most often it is~     caused by entrapment of an intercostal nerve in the anterior rectus sheath, the Anterior~     Cutaneous Nerve Entrapment Syndrome (ACNES). Treatment consists of local anaesthetic~     injections combined with methyl-prednisolon. When ineffective, a neurectomy at the site of~     penetration out of the ventral rectus sheet should be considered. This neurectomy however is~     effective in 73% of cases, leaving some 25% of patients in pain. Whether these refractory~     ACNES patients suffer from underlying pathologic pain disorders is subject to investigation,~     by using quantitative sensory testing (QST).~      Objective: To investigate nociceptive processing and possible underlying pathological pain~     processing mechanisms in ACNES patients.~      Study design: An observational case-control study.~      Study population: Patients treated for ACNES (n = 50) compared to healthy controls from an~     existing database.~      Measurements: Quantitative sensory testing (QST) of nociception, performed after treatment of~     ACNES for both successfully treated and refractory patients in comparison to healthy~     controls. Visual Analogue Scores (VAS) measured before, during and after testing procedures.~     Pain Anxiety Symptom Scale (PASS) and Pain Catastrophizing Scale (PCS) questionnaires.~      Main study parameters: Pressure pain and electrical pain thresholds as investigated by QST.~     Secondary study parameters are VAS-scores and results of PASS and PCS questionnaires.~   "
125799|NCT01920867|"~     This study will evaluate the use of autologous bone marrow derived stem cells (BMSC) for the~     treatment of retinal and optic nerve damage or disease. http://mdstemcells.com/scots-ii/~   "
125800|NCT01920854|"~     The purpose of this study is to determine the pharmacokinetics of fixed ascending doses of~     intravenously administered Soluble Ferric Pyrophosphate~   "
125801|NCT01920841|"~     The purpose of this study is to evaluate efficacy of two lipolytic creams differing in their~     bases and demonstrate that their herbal ingredients can reduce the size of the thigh and~     smooth the appearance of the thigh skin. It is hypothesized that creams with two different~     cream bases containing herbal products that stimulate the lipolytic process through~     stimulation of the beta-adrenergic receptor, with one cream base applied to each thigh daily~     5 days a week for 4 weeks will reduce thigh girth and smooth the thigh skin compared to~     baseline.~   "
125802|NCT01920828|"~     The purpose of this study is to learn about gait (walking) characteristics in MPS IVA and~     possible changes in gait with enzyme replacement therapy.~   "
125803|NCT01920815|"~     In order to determine the effectiveness of medical therapy options to prevent enlargement of~     the aorta in patients with a bicuspid aortic valve, a randomized study will be planned. This~     feasibility study will gather accurate data on number needed to screen, changes in medication~     use over time, and variance of the intended study endpoint.~   "
125804|NCT01920802|"~     The purpose of this pilot randomized clinical trial is to begin to delineate the~     pathophysiological changes associated with antipsychotic associated metabolic side effects.~     The study will be performed in 36 healthy people between the ages of 18 and 30, who have~     never taken an antipsychotic, will undergo baseline laboratory tests before being randomized~     to 5mg BID of olanzapine or 6mg BID of iloperidone or placebo to take for up to 4 weeks. The~     primary outcome measure will be a correlation of early changes in leptin with weight gain. We~     will also record changes in food intake, resting metabolic rate, oral glucose tolerance and~     fasting insulin and glucose levels, lipids and inflammation markers. Subjects will be~     followed closely to monitor for safety throughout the 4-week study and will be discontinued~     if there is a medically significant change in metabolic status or other antipsychotic side~     effects. Metabolic assessments will be performed again at the time of discontinuation or at~     the end of an 4-week period, and change from baseline in the two treatment groups will be~     compared.~   "
125805|NCT01920789|"~     A randomized phase II study for medically inoperable stage I non-small cell lung cancer where~     stereotactic body radiotherapy in three fractions to 66 Gy is compared with conventionally~     fractionated radiotherapy to 70 Gy in 35 fractions.~   "
125806|NCT01920776|"~     The investigators hypothesize that lung ultrasound and echocardiography will benefit the~     septic shock patients by making the treatment more precisely and rapidly. Septic shock~     patients from multicenter will be enrolled in the study. They will be randomly divided into~     two groups. The routine treatment group will receive routine treatment according to the SSC~     guideline. The study group will receive additional ultrasound examination, which will decide~     the improvement of therapy. Therapy change based on ultrasound results and the prognosis will~     be recorded.~   "
125807|NCT01920763|"~     This pilot study will examine the safety and the clinical outcomes after minimally invasive~     surgery (using a parafascicular technique guided by diffusion-tensor imaging) for~     intracerebral hemorrhage in patients selected according to evidence-based criteria. The~     investigators will compare 30 day and 90 day outcomes of patients who have surgery to that~     predicted by previously reported models for recovery after ICH, and will also describe any~     surgical complications related to the procedure.~      The investigators hypothesize that this technique will have the same mortality rate and~     function outcome, if not better, when compared to the outcomes predicted by previous models.~   "
125808|NCT01920750|"~     This is a small Phase I trial to evaluate the safety of the use as skin test antigens of the~     immunologically active proteins from the soluble/cytosol and insoluble cell wall of~     Mycobacterium leprae. The overall objective is to generate new leprosy skin-test antigens,~     equivalent to tuberculin-PPD in the tuberculosis context, to be used (I) for the early~     diagnosis of leprosy; and (ii) as epidemiological tools to measure the incidence of disease.~     Evaluating new leprosy skin test antigens may provide a better way to diagnose leprosy in its~     early stages of infection. With the early administration of drug therapy, infected~     individuals can then be cured of this disease before nerve damage occurs or nodules~     (lepromas) start to develop on the skin. Ten healthy, leprosy-unexposed, tuberculin-negative~     volunteers, 18-40 years old, from within the staff of the Mycobacteria Research Laboratories,~     Department of Microbiology, Colorado State University, Fort Collins, Colorado, will be~     selected.~   "
125809|NCT01920737|"~     The purpose of the study is to find out whether the combination of chemotherapy drugs that~     are routinely used in children with ALL, will be safe and effective in treating adult~     patients with ALL. The standard treatment for adults with ALL consists of many chemotherapy~     drugs that are given in different combinations and in several steps. In adult ALL there is no~     standard which drugs to give and how to combine them. Some leukemias have a chromosome~     abnormality called Philadelphia chromosome (also called Ph Positive) and some leukemias do~     not (called Ph Negative). In this study we want to see whether this combination of~     chemotherapy drugs will be safe and effective in treating adult patients with Ph Negative~     ALL.~   "
125810|NCT01920724|"~     Thailand has been facing with the double burden of malnutrition. Many studies in Thailand,~     which aim to explore the situation, causes, and strategies to prevent obesity, have focused~     on adults, adolescents, or school-aged children. Few studies have been conducted in preschool~     children. Obesity or stunting during childhood increases the risk of being obesity in~     adulthood and leads to chronic diseases. If obesity is established in adulthood, it is~     difficult to reduce the excess weight. Thus, the prevention of obesity or stunting in young~     children should be highly considered. Study of dietary pattern and reliable field methods to~     measure fat mass (FM) in children may partly contribute to primary prevention of childhood~     obesity. The deuterium dilution technique is an accurate and suitable method for children and~     population-based studies. However, it has not been widely used in children in Thailand.~     Hence, this study aimed to utilize the deuterium dilution technique for assessing body~     composition and to determine the quality and quantity of dietary intake among children 3-5~     years of age with different nutritional status. We conducted a cross-sectional study in 15~     daycare centers in Nakhon Pathom and Samut Prakarn provinces. 120 preschoolers were~     purposively selected according to their nutritional status: stunted, thin, normal, and~     overweight/obese. Anthropometric measurements were conducted. Body composition was determined~     based on total body water using deuterium dilution technique. Dietary intake data were~     obtained using 2-day 24 hr recall.We hypothesized that stunted and obese children will have~     more fat mass compared to the normal children.~   "
125811|NCT01920711|"~     The purpose of this study is to evaluate the effect of LCZ696 compared to valsartan in the~     reduction of cardiovascular death and heart failure(HF) hospitalizations in patients with HF~     with preserved ejection fraction.~   "
125812|NCT01920698|"~     The objective of this trial is to compare the safety, the efficacy and the cost-effectiveness~     of 2 therapeutic strategies (optimal standard of care therapy alone versus percutaneous~     MitraClip procedure and optimal standard of care therapy) in patients with severe secondary~     mitral regurgitation.~      This trial is a French, multicenter and randomized trial. Patients enrolled will be~     clinically followed for 2 years (phone call at 1 month, clinical visit at 6 months, 12 months~     and 24 months).~   "
125813|NCT01920685|"~     People with a schizophrenia spectrum diagnosis often experience distressing worries or~     beliefs about others intending to cause them harm (also known as paranoia). Paranoid beliefs~     are associated with significant distress and disruption to the person's life. This results in~     high use of services and costs to mental health providers.~      The National Institute of Clinical Excellence recommends that cognitive behavioural therapy~     for psychosis (CBTp) is offered to everybody with a schizophrenia spectrum psychosis. The~     latest meta analyses report improved outcomes, and reduced inpatient stays following CBTp,~     making it a cost effective intervention.~      Although improved outcomes have been obtained by therapies, CBTp has only small to moderate~     effects on paranoid beliefs. Further, training therapists to competently deliver CBTp is~     intensive, expensive and takes up to a year. CBTp is therefore not widely available to~     service users, resulting in inequalities in access to care.~      The investigators are seeking to improve outcomes and accessibility of CBTp for people with~     distressing, paranoid beliefs. The proposed research programme aims to conduct a feasibility~     study of a brief therapeutic intervention, aimed at targeting and improving anxiety processes~     that are causally implicated in paranoia (Freeman et al, 2015).~      The investigators have preliminary evidence indicating that the pilot intervention, with~     interactive multimedia content, reduced distressing beliefs and improved coping (Freeman et~     al, 2015). Participants also reported they found the therapy acceptable, enjoyable and~     useful. Based on these results, the investigators have further modified the intervention. The~     feasibility and efficacy of the therapy will be investigated in a randomised controlled~     design (n = 34).~      Please note the protocol has been been amended to exclude a pilot trial of a second brief~     intervention targeting reasoning styles in paranoia, as since the initial protocol was~     developed we have obtained data from two randomised pilot studies demonstrating its~     feasibility and acceptability (Garety et al, 2015; Waller et al, 2015). A further pilot trial~     of the reasoning styles intervention is therefore not indicated.~   "
125822|NCT01920568|"~     This is a randomized, double-blind, double-dummy study designed to provide bridging data in~     an Asian population to Amgen's studies of denosumab in subjects with bone metastases from~     solid tumors. The study is designed to provide data to a large global dataset of phase-III~     studies including breast cancer, prostate cancer, and all solid tumors, plus multiple~     myeloma, to support the regulatory approval for marketing and patient access to denosumab for~     the prevention of SREs in Chinese subjects with bone metastases from solid tumors. The~     primary objective of this study is to evaluate and compare the percent change from baseline~     to Week 13 in the bone marker urinary amino-terminal cross-linking telopeptide of type I~     collagen (uNTx) corrected for urine creatinine (uNTx/uCr) in subjects treated with denosumab~     to those treated with zoledronic acid. The study is designed to test the superiority of~     denosumab over zoledronic acid.~   "
125814|NCT01920672|"~     Over 5 million Americans have Alzheimer's disease or a related dementia, a progressive and~     irreversible neurodegenerative condition, affecting also close to 15 million family~     caregivers (CG). Sleep efficiency in AD patients is severely impaired and complicated by~     frequent night awakenings and nocturnal restlessness. Untreated sleep disruption in AD~     patients is associated with increased rates of neuropsychiatric symptoms, daytime napping,~     'sundowning' behaviors, cognitive and functional decline, and morbidity and mortality. The~     added strain of sleep disruption is the primary reason family caregivers make the decision to~     institutionalize AD patients. The circadian abnormalities in the sleep-wake cycle commonly~     observed in AD patients occur more often in individuals with hypothalamic/ pituitary/adrenal~     (HPA) axis hyperactivity. HPA axis hyperactivity may influence diurnal sleep-wake activity by~     diminishing an AD patient's ability to respond to external zeitgebers which, in turn, can~     further propagate HPA axis dysfunction. Thus, interventions to normalize diurnal HPA axis~     patterns may be beneficial in treating sleep-wake disturbances. Nonpharmacologic treatments~     are the first line therapy in AD patients with sleep wake problems, given the ineffective and~     potentially harmful effects of pharmacologic agents. Current clinical sleep hygiene practices~     in institutional (e.g., nursing home) settings holds promise for reducing disruptive sleep by~     reestablishing circadian patterns in HPA functioning. These interventions include use of~     timed and planned activities during daylight hours and creating a relaxing environment in the~     evening. However little systematic work has been done to determine the efficacy of these~     interventions in the home setting (where most individuals with AD reside).~      We propose a pilot study to (a) characterize objective sleep parameters and behavioral~     symptoms of sleep-wake disturbance, and biological indicators of diurnal HPA axis activity in~     a sample of community residing older adults with AD: (b) examine the effects of timed and~     planned activities on subjective and objective characteristics of sleep, behavioral symptoms,~     and HPA status; and (c) evaluate measurement approaches in home-dwelling AD patients.~     Subjective (CG questionnaires) and objective (wrist actigraphy) characteristics of sleep and~     behavioral symptoms will be measured in fifty-four AD patients being cared for at home by a~     family. Patients and CG with then be randomized to receive an intervention of timed, planned~     activities (TPA) or attention control (AC) condition. We will also obtain diurnal measures of~     HPA activity including salivary cortisol and alpha amylase.~   "
125815|NCT01920659|"~     Physical activity is a powerful lifestyle factor that on average reduces risk for development~     of diabetes and cardiovascular disease. Nevertheless, investigators have demonstrated that~     following supervised endurance exercise training, 20% of subjects show no change in fitness~     and 30% demonstrate no improvement in insulin sensitivity.~      Our concept is that by using molecular profiling of blood/muscle samples investigators will~     develop personalised lifestyle intervention tools. Further, revealing the biological basis~     for a variable metabolic or cardiovascular response to exercise will enable us to propose new~     targets and biomarkers for drug discovery efforts directly in humans. Using our established~     OMICS approaches (RNA, DNA and Metabo-) investigators will generate classifiers that predict~     the responses to exercise-therapy (fitness and insulin sensitivity). Classifier generation is~     a statistical strategy for diagnosis or prognosis. Critically, investigators have a large~     human tissue biobank, including subjects with insulin-resistance; young to elderly males and~     females, as well as twins. Our SME partner has significant intellectual property and capacity~     in the field of bio-prediction, with a proven track-record of collaboration with the team and~     product development. Investigators will add to the diversity of our biobank by carrying-out~     an exercise intervention study using a novel time-efficient strategy that investigators have~     recently proven to be effective in reducing insulin resistance in sedentary young people and~     in middle aged obese subjects. A time-efficient protocol is a critical as lack-of-time is a~     key reason for not maintaining physical activity levels. Finally, investigators have a novel~     out-bred rodent model that replicates high and low exercise training responses and~     investigators will establish its suitability for future drug screening purposes. Because of~     these substantial pre-existing resources investigators believe that our project has a very~     high probability of delivering on its goals of improving the healthcare of European citizens.~   "
125816|NCT01920646|"~     The combination of poverty-related infectious and lifestyle-related non-communicable~     diseases, both driven by malnutrition, causes a high burden for South Africa. Healthy and~     nutritious diets for populations depend on availability and accessibility of a variety of~     plant and animal foods, within a context that promotes and supports healthy behaviour. Food~     based strategies, such as supplementation, food fortification, and diversification of crops,~     are used to achieve optimal dietary requirements to combat malnutrition, including~     micronutrient deficiencies. A more sustainable food based strategy is the (promotion of) use~     of indigenous and traditional foods, such as African Leafy Vegetables (ALVs). Unfortunately,~     several studies from all over Africa have shown that there is a shift from traditional diets~     as result of the preparing techniques and the absence of women in homes. Furthermore,~     indigenous and traditional foods are considered as poor people's food.~      Against this background, a joint project between South Africa, Kenya and Benin is designed to~     fill the gaps in knowledge in these countries regarding the availability, acceptability and~     consumption and evidenced based benefits of foods from local biodiversity. The main aim of~     the study in South Africa is to provide empirical evidence of how the role of biodiversity~     can be translated into improved health status in contemporary poor rural and urban~     communities in the North West Province of South Africa. In order to achieve this it is~     important to gain knowledge on the possibility of using ALVs as a strategy to alleviate~     micronutrient deficiencies. Therefore an intervention study to determine the effect of~     selected ALV on the nutritional status (including zinc, iron, and vitamin A status) of school~     children (grade R-4) residing in contemporary poor rural community in the North West~     Province, South Africa has been designed.~   "
125817|NCT01920633|"~     This is a single visit study in which people with Down syndrome aged 12-30 will attend the~     clinical center to undergo assessments to evaluate their eligibility for potential enrollment~     in the future BP27832 Phase II clinical study which will evaluate the efficacy, safety and~     tolerability of RG1662. Study participants may withdraw from this study at any time and for~     any reason.~   "
125818|NCT01920620|"~     In this study we sought to determine whether inpatient weight loss counseling with post~     discharge phone follow-up would result in weight loss at six months. Secondary endpoints~     included weight change from baseline, changes in waist-to-hip ratios, assessment of weight~     perceptions and changes in patient reported health outcome measures. To our knowledge, this~     is the first randomized trial designed to evaluate the effects of an obesity intervention~     with post-discharge follow-up in an inpatient general medicine population.~   "
125819|NCT01920607|"~     The purpose of this study is to compare 2 surgical treatments of severe fecal incontinence~     (defined as more than a major leak per week). The hypothesis of this non-inferiority trial~     is that magnetic anal sphincter is clinically as effective as SNS, but more cost-effective in~     managing fecal incontinence~   "
125820|NCT01920594|"~     This study will test the hypothesis that GSK1278863 will reduce neurologic, renal, and/or~     cardiac ischemia in patients undergoing elective descending thoracic aorta/thoracoabdominal~     aortic aneurysm (DTA/TAAA) repair, a population known to be at high risk for ischemic events~     from their underlying pathology and the surgical complexity required to address their~     disease. Approximately 160 subjects will be stratified according to intervention type~     (surgical or endovascular repair, with the latter limited to 50% of the total study~     population) and randomized in a 1:1 fashion to treatment with GSK1278863 (300 milligrams~     [loading dose] followed by 100 milligrams [mg]/day x 4 days) or placebo starting prior to~     planned repair, through postoperative day 3. The duration of participation in this study is~     expected to be approximately 4 to 8 weeks from screening to follow-up.~   "
125821|NCT01920581|"~     The aim of this study is to evaluate benzodiazepines and related drugs (zolpidem and~     zopiclone) usage in an outpatient population of chronic users over 65 years in France using a~     questionnaire assessing substance dependence according to DSM-IV (Diagnostic and Statistical~     Manual of mental disorders) international standards.~   "
125823|NCT01920555|"~     This study is looking at the efficacy, durability, safety, and tolerability of multiple~     single doses of Ketamine vs. active placebo for treating patients with treatment resistant~     depression who are taking an antidepressant that is not working for them.~   "
125826|NCT01920516|"~     In-transit metastases occur in approximately 3% of melanoma patients, can be very symptomatic~     and the survival in this group may be prolonged. In-transit melanoma metastases are often~     confined to a limb. In this circumstance, treatment by isolated limb perfusion or isolated~     limb infusion can be a remarkably effective regional treatment option. Isolated limb infusion~     (ILI) was introduced in 1992 and is a technique used to deliver regional chemotherapy to~     treat advanced melanoma confined to a limb. Regional chemotherapy with melphalan delivered by~     isolated limb perfusion (ILP) or ILI are effective treatment options for in-transit melanoma~     and are generally well tolerated.~      ILI is a less invasive and simpler alternative to ILP. Complete response rates are 45- 69%~     for ILP and 23-44% for ILI. The limb is often warmed to lower temperatures in ILI compared to~     ILP and the limb becomes progressively more hypoxic and acidotic during ILI, each of these~     parameters potentially having an effect on outcome. ILP & ILI are used primarily as~     palliative options when excision of in-transit metastases is unfeasible but can be used as an~     adjunctive procedure to surgery, for other tumour types such as merkel cell carcinoma, and~     can be repeated if indicated. For ILI correction of melphalan dose for ideal body weight has~     been shown to substantially decrease the rates of severe local toxicity while maintaining~     complete response rates, but overall response rate is reduced.~      Response to ILI, moreover, is different in upper and lower limbs. ILI for Upper limbs disease~     is associated with similar complete response rates but lower toxicity than ILI for Lower~     limbs E disease and with different physiologic sequelae despite comparable methods. The Upper~     limbs appears relatively resistant to toxic effects of melphalan-based ILI as currently~     performed, which suggests a potential for further optimization of drug dosing for Upper limbs~     ILI.~      Regional therapy is an excellent therapeutic modality for disease limited to a limb and~     furthermore serves as an excellent model for scientific investigation, both clinical and~     translational. In this study we want to collect data on isolated limb infusion of~     chemotherapy to monitor efficacy and tolerability in patients with melanoma metastases of the~     arm or leg that cannot be removed by surgery.~   "
125827|NCT01920503|"~     Cholangiocarcinoma is a rare and very aggressive neoplasm that arises from the biliary~     epithelium, constitutes approximately 2% of all reported cancer, and accounts for about 3% of~     all gastrointestinal malignancies. Up to date, there are many modalities to diagnosis and~     treat with a range of sensitivity and specificity, and also the advantage and disadvantage of~     its modality. Cholangiocarcinoma has a poor prognosis. Surgical resection offers the only~     curative option and usually requires a major hepatic resection in addition to resection of~     the cholangiocarcinoma. Unfortunately, curative resection is possible in only about 30% of~     patients due to locally advanced disease, distant metastases or comorbidity in elderly~     patients. Even after resection, the recurrence rate is approximately 60%, resulting in a low~     5-year overall survival (OS).~      Patients with intra-hepatic Cholangiocarcinoma (ICC) have a very limited benefit from~     systemic chemotherapy, indeed, in unresectable cholangiocarcinoma Overall Survival with~     systemic chemotherapy is less than 1 year. Since most cholangiocarcinoma patients develop~     distant metastases at late stages only, locoregional therapy is an interesting therapeutic~     strategy.~      Locoregional therapy studies in patients with intrahepatic cholangiocarcinoma employing~     radiofrequency ablation (RFA), transarterial chemoembolization (TACE) or external as well as~     internal radiation therapy yielded promising results in the last couple of years.~      TACE is safe and may be effective for prolonging the survival of patients with nonresectable~     combined hepatocellular carcinoma (HCC) -cholangiocarcinoma, as compared with the~     historically reported survivals of these patients. Tumor vascularity is highly associated~     with tumor response. The patient survival period after TACE for combined~     HCC-cholangiocarcinoma is significantly dependent on tumor size, tumor vascularity,~     Child-Pugh class, and presence or absence of portal vein invasion.~      Currently, few centers perform TACE therapy for unresectable Cholangiocarcinoma. Several~     European studies have reported the efficacy and safety TACE for ICC.~      The establishment of a registry to obtain the majority of Cholangiocarcinoma cases treated~     with locoregional approach within and outside Europe can help the investigators evaluate a~     larger and non-ambiguous sample population. This would help the investigators evaluate the~     technical success rates, clinical success rates, feasibility and safety of TACE for ICC.~   "
125828|NCT01920490|"~     The investigators have shown that decoupling of brain networks when feeling guilty is the~     first potential functional neuroimaging biomarker of risk of major depression. It remains~     detectable on remission of symptoms (Green et al., 2012). Decoupling of neural networks was~     found while people felt guilty during functional magnetic resonance imaging (fMRI) relative~     to feeling indignation. Guilt-selective brain decoupling is therefore an excellent target for~     interventions to reduce the largely increased risk of recurrent episodes in people who have~     had one episode but are currently remitted. To our knowledge, however, there is no~     proof-of-concept study showing that self-blame-selective decoupling on fMRI can be detected~     and fed back to the participants after a short temporal delay in a real-time fMRI setting and~     whether coupling can be increased through neurofeedback training. This project aims at~     developing the first fMRI neurofeedback system to treat self-blame-selective neural~     decoupling and to test its feasibility in people with major depressive disorder currently~     remitted from symptoms.~   "
125829|NCT01920477|"~     Pemphigus vulgaris (PV) is a rare, chronic, debilitating, and potentially life-threatening~     autoimmune disorder that is characterized by mucocutaneous blisters. Ofatumumab is a novel~     monoclonal antibody (mAb) that specifically binds to the human CD20 antigen, which is~     expressed only in B lymphocytes.~      The purpose of this study is to evaluate the efficacy, tolerability, and safety of ofatumumab~     injection for subcutaneous use (ofatumumab SC) 20 milligrams (mg) administered once in every~     4 weeks, (with an additional 20 mg loading dose [i.e. 40 mg total] at both Week 0 and Week 4)~     in subjects with PV. It is anticipated that with sustained B-cell depletion in the presence~     of ofatumumab SC, and the resultant reduction of pathogenic anti Dsg (desmoglein)~     autoantibodies in PV, that clinical remission of the disease will result.~   "
125830|NCT01920464|"~     this study has been request by french health authorities to evaluate the use of flixovate in~     infants and its place in the treatment pathway.~      this study has 2 main pbjectives: 1/ Evaluation of changes in the prescription share of~     Flixovate® compared to other topical corticosteroids (low, medium and high potency) in the~     population of infants aged from 3 to 12 months, from 1st January 2010 to 31st December 2012.~     2/Description of the conditions of use of Flixovate® in infants aged less than 12 months~     (infant profile, dosage form, dosage, treatment duration, prior, concomitant and subsequent~     treatments etc.).~   "
125831|NCT01920451|"~     Sleep disturbance and posttraumatic stress disorder (PTSD) are common conditions in returning~     Veterans, and both conditions are known to increase the risk of cardiovascular disease.~     Research suggests that those with insomnia are at triple the risk of high blood pressure as~     compared to normal sleepers, and that having both insomnia and short sleep increases this~     risk to more than five times that of normal sleepers. These research findings suggest that~     recently deployed Veterans with insomnia may be at increased risk of developing high blood~     pressure, and this possibility is consistent with previous research. Vietnam era Veterans~     with combat-related PTSD assessed in 1985 were twice as likely to have died of early-onset~     heart disease relative to their non-PTSD counterparts when reassessed in 2000.~      Evidence for impaired cardiac function in individuals with PTSD has been demonstrated across~     several studies as well. Compared to individuals without PTSD, those with PTSD seem to have~     lesser reaction to stress in terms of both heart rate and heart beat pattern. However, there~     has been very little research examining the impact of behavioral sleep interventions on~     health outcomes, and even fewer that are specific to a PTSD or Veteran population. The~     purpose of this study is to determine if treating insomnia results in improved blood pressure~     and cardiac function in recently deployed Veterans with PTSD. The findings of this research~     will serve as pilot data for a future grant application testing the efficacy of~     Cognitive-Behavioral Therapy for Insomnia (CBTI) for reducing cardiovascular risk in Veterans~     with PTSD using a full-scale randomized trial design. We are hypothesizing that improved~     sleep will be significantly associated with improved blood pressure and increased heart rate~     variability (improved autonomic function) in adults receiving CBTI compared to those in a~     wait-list control condition.~   "
125854|NCT01920152|"~     The objective of this study is to compare the clinical efficacy of intra-articular injections~     of autologous platelet rich plasma (PRP) vs hyaluronic acid (HA) for symptomatic early~     osteoarthritis (OA) of the hip. Secondarily, this study aims to determine the feasibility and~     safety of treating early OA of the hip with HA and PRP.~   "
125832|NCT01920438|"~     A gastrostomy is a feeding tube that communicates from the skin directly into the stomach. It~     is a device frequently used in children that have feeding difficulties or are unable to~     maintain normal growth via oral feeds. The same device may be inserted in two ways: the~     percutaneous endoscopic method (PEG) which is guided by the use of an endoscope (flexible~     camera), or the radiologically inserted method (RIG) which is guided by the use of X-ray~     imaging. Both methods of insertion have been used in children for more than 20 years, but it~     is not clear which is the best method. Both methods are associated with complications,~     including injury to other abdominal organs and leakage leading to sepsis. There are no~     randomised controlled trials comparing the two techniques.~      We aim to compare the outcome of both methods of gastrostomy insertion in children, with~     emphasis on the complication rates. We have devised a complication score with weightage~     assigned to each complication according to its severity.~      A randomised controlled trial will be performed in children requiring a gastrostomy, 100 per~     group. The primary outcome will be the overall total complication rate.~   "
125833|NCT01920425|"~     The objective is to compare the sensitivity and test-retest reliability of Kinesia HomeView~     to electronic and hand-written diaries for tracking medication state in the home.~     Demonstrating comparable or superior results will further support use of the Kinesia HomeView~     system as an outcome measure in clinical drug trials.~   "
125834|NCT01920412|"~     This study mainly evaluated the feasibility and safety of LAmbre Left Atrial Appendage~     Occluder which is to prevent ischemic stroke caused by atrial fibrillation(AF).~   "
125835|NCT01920399|"~     Investigate the safety and tolerability, as well as PK profile of ceftazidime-avibactam (CAZ~     -AVI) administered in single and repeated intravenous (IV) infusions in healthy Chinese~     subjects.This study data will be used to support CAZ-AVI NDA in China.~   "
125836|NCT01920386|"~     A randomized, double-blind, active-controlled, parallel, multicenter Phase 3 study of~     Tramadol hydrochloride/Acetaminophen SR Tab. & Tramadol hydrochloride/Acetaminophen Tab. in~     Acute Toothache Patients above Moderate Pain after Teeth Extraction Surgery.~   "
125837|NCT01920373|"~     1.0 BACKGROUND AND HYPOTHESES~      1.1 Osteoarthritis is a continuous and entirely physiologic adaptive process that occurs in~     every joint. These include the replication of cells that produce matrix, enzymes, protease~     inhibitors, cytokines, and other peptides. Along with the synthesis of new tissue there is a~     release of breakdown products into the synovial fluid. Enzymes and phagocytes are required to~     clear these breakdown products. Normal tissue turnover involves synthesis and breakdown in~     well-regulated balance. In the degenerative state this balance is upset producing~     inflammation-derived alterations to the synovium, cartilage, capsule, tendons, and bone.~     Common causes of such alterations include increased loading, physical stress, and traumatic~     injury to the joint.~      1.2 The rationale for the use of corticosteroids in temporomandibular joint therapy is that~     they inhibit prostaglandin synthesis and decrease the activity of collagenase and other~     enzymes that degrade the articular cartilage. Platelet rich plasma is a novel therapeutic~     agent that has several potential advantages over corticosteroids for the treatment of~     degenerative pathology of the temporomandibular joint. Platelet rich plasma has been shown to~     have anti-inflammatory, analgesic, and anti-bacterial properties. It also restores~     intra-articular hyaluronic acid, increases glycosaminoglycan condrocyte synthesis, balances~     joint angiogenesis, and provides a scaffold for stem cell migration. Autologous platelet rich~     plasma injections for treatment of knee cartilage degenerative lesions and osteoarthritis~     have shown longer efficacy than hyaluronic acid injections in reducing pain and recovering~     articular function. Similarly, platelet rich plasma has shown to have better outcomes than~     corticosteroid injections in the management of lateral epicondylitis, and better outcomes~     than hyaluronic acid injections in the management of osteochondral lesions of the talus.~      1.3 Current treatments for degeneration and osteoarthritis of the temporomandibular joint are~     focused primarily on palliation by reducing inflammation and inflammatory mediators. This~     study seeks to validate a therapeutic agent that has the potential to actively prevent the~     progression of degeneration in addition to reducing pain and inflammation~   "
125838|NCT01920360|"~     The objectives are to evaluate the effects of immersion bath with sulphurous water in pain,~     joint mobility and quality of life in patients with knee osteoarthritis. Patients will~     undergo three weekly baths in sulphurous water and not sulphurous, twenty minutes each, for~     ten weeks.~      The expected results are: reduction of pain, improved range of motion of the lower limbs with~     consequent increase in muscle mass improvement in postural balance, which will come due to~     the reduction of pain and improvement movements of the lower limbs; greater independence in~     performing the activities of daily living, better quality of life.~   "
125839|NCT01920347|"~     The trial will evaluate the use of the Neurological Pupil index NPi, measured with the~     digital pupillometer (NeurOptics) compared to clinical examination for better reliability.~     The investigators hypothesize that digital evaluation will offer a higher sensitivity/~     specificity compared to clinical examination.~   "
125840|NCT01920334|"~     A double blind, randomized, placebo-controlled study will be conducted in cardiac ICU~     patients who had been diagnosed with acute coronary syndrome, using a sleep promoting drug~     (zolpidem controlled release).~      The study hypothesis is that sleeping better can improve the heart recovery in patients with~     a diagnosis of acute coronary syndrome.~   "
125841|NCT01920321|"~     Aim: To evaluate feasibility, safety and efficacy of relatively simple approach of~     bronchoscopic lung volume reduction (LVR) technology, independent of collateral ventilation.~      Description: Patients with severe upper lobes heterogeneous emphysema, undergo unilateral~     bronchoscopic installation of saline thermal energy 50-55 ºC intending to induce an~     inflammatory airway and parenchymal injury and consequently fibrotic response resulting in~     LVR;~   "
125842|NCT01920308|"~     The purpose of this study is to assess the deliverability, clinical utility and effectiveness~     of the 5 mm diameter size offering of the LifeStent® Vascular Stent~   "
125843|NCT01920295|"~     Cryoballoon ablation of paroxysmal atrial fibrillation can be used as first-line therapy~     compared to second choice after failed medical therapy~   "
125844|NCT01920282|"~     Numerous anti-hypertensive drugs have been reported to be efficacious in reducing central~     arterial stiffness and these effects may contribute to improved outcomes in hypertensive~     patients. However, the results of several studies suggest that beta-blockers may actually~     increase arterial stiffness. In contrast, there is limited evidence to suggest that~     nebivolol, a third generation beta-blocker that augments release of vascular nitric oxide,~     reduces central arterial stiffness in hypertensive individuals. Unfortunately, only a few~     studies have addressed this issue and all of these studies relied on indirect, blood pressure~     dependent measures of arterial stiffness. In addition, none of these studies focused on~     middle-aged and older, obese hypertensives, a population with accelerated arterial stiffening~     and at risk for cardiovascular diseases. Thus, the potential utility of nebivolol as a~     therapy to reduce large artery stiffness, particularly among the latter population, remains~     unclear.~   "
125855|NCT01920139|"~     The study was performed to determine if either ultrasound guided core biopsy or fine needle~     aspiration of an axillary lymph node has superior sensitivity in detecting metastatic~     carcinoma from the ipsilateral breast.~   "
125845|NCT01920269|"~     In laboratory and clinical studies, intravesical electromotive drug administration increased~     mitomycin bladder uptake, improving clinical efficacy in high-risk non-muscle invasive~     urothelial bladder cancer. The investigators' aim was to compare transurethral resection of~     bladder tumor and adjuvant intravesical electromotive mitomycin with transurethral resection~     and adjuvant intravesical passive diffusion mitomycin and transurethral resection alone in~     patients with primary stage pTa-pT1 and grade G1-G2 urothelial bladder cancer Patients will~     be randomly assigned to: transurethral resection alone, transurethral resection and adjuvant~     intravesical 40 mg passive diffusion mitomycin dissolved in 50 ml sterile water infused over~     60 minutes once a week for 6 weeks, or transurethral resection and adjuvant intravesical 40~     mg electromotive mitomycin dissolved in 100 ml sterile water with 23 mA pulsed electric~     current for 30 minutes once a week for 6 weeks. Patients in the intravesical adjuvant~     electromotive and passive diffusion mitomycin groups who are disease-free 3 months after~     induction treatment, will be scheduled to receive monthly intravesical instillation for 10~     months, with the same dose and methods of infusion as initial assigned treatment. All~     patients will be assessed for safety. The investigators' primary endpoints are recurrence~     rate and disease-free interval. Analyses will be done by intention to treat.~   "
125846|NCT01920256|"~     Patients with type 2 diabetes can attain superior disease outcomes if multiple therapy goals~     are simultaneously achieved and maintained. In reality, therapy goals are seldom achieved,~     and patients become susceptible to devastating complications and greater health care~     expenses. Studies have shown that regular monitoring and therapy adjustments are a~     prerequisite to achieving and maintaining therapy goals. Unfortunately implementation of~     regular monitoring and therapy adjustments have been hindered by high clinic workload and~     shortage of endocrinologists. Due to this shortage, endocrine care is accessible to less than~     20% of patients with type 2 diabetes. The overwhelming majority are managed by providers who~     may lack the necessary expertise or time to deliver optimal disease management, particularly~     when insulin is prescribed.~      Objectives: We hypothesize that type 2 diabetes endocrine clinics for high-risk patients that~     complement primary care, personalize the frequency of remote disease interventions and employ~     infrequent face-to-face outpatient visits, will achieve comparable clinical outcomes and~     patient satisfaction compared to usual endocrine clinic care, while reducing workload and~     increasing the clinic capacity. The intervention clinic will employ regular remote~     communications initiated by the endocrinologists, based on tailored individual plans.~     Frequent remote monitoring and interventions will reinforce attainment of the therapy goals~     and allow a decrease in the frequency of outpatient visits. In turn, the clinic workload will~     decrease and it will be able to accommodate more patients with type 2 diabetes than~     traditional endocrine clinics. The aims of the study are to test this new endocrine clinic~     model in a clinical trial by monitoring clinical parameters, patient satisfaction and~     clinical workload. The long-term objectives are to modify the current model of endocrine care~     for patients with type 2 diabetes.~   "
125847|NCT01920243|"~     This study will look at the use of a telehealth version of a self management program in~     individuals with both new onset and chronic traumatic spinal cord injuries. The program is~     called Health Mechanics. It is meant to enhance self management skills related to neurogenic~     bladder and bowel management to prevent associated problems and improve Quality of Life~     (QOL). This program is based on the needs and strengths of individuals with SCI. It focuses~     on enhancing skills, encouraging positive health behaviors, empowering people within their~     own environments, and recognizing that people differ in their resources and abilities. The~     skills that are part of the intervention are: attitude, self-monitoring, problem-solving,~     communication, organization and stress management. This study will address those skills in~     the context of bladder and bowel health, with expectations that these skills to be useful in~     other areas of life as well.~      The investigators hypothesize that individuals in the Health Mechanics intervention group~     will:~        -  show greater improvements in problem solving skills, healthy attitudes about disability~          and knowledge of SCI management skills than will the control group~        -  have greater adherence to recommended bladder and bowel management behaviors than the~          control group~        -  have fewer bladder and bowel complications than the control group~        -  have higher levels of QOL than the control group~      In other words, this study will investigate the effectiveness of a telehealth version of~     Health Mechanics to enhance self-management skills related to neurogenic bladder and bowel~     management in an attempt to prevent associated complications and improve QOL.~   "
125848|NCT01920230|"~     The aim of this study is to examine the effectiveness of intervention based on mindfulness~     and acceptance-commitment therapy (ACT) in the recovery from job burnout. The 8-week~     intervention is delivered using jointly face-to-face group meetings and web-based program.~     The study hypothesizes that the Muupu-program is more effective than the normal practices~     when promoting work well-being in Finland. The participants are recruited from Finland.~   "
125849|NCT01920217|"~     Sepsis is a common cause of death in intensive care unit, timely and accurate diagnosis and~     treatment directly affect the survival rate. Single nucleotide polymorphism (SNP) was~     promising genetic biomarker for sepsis patients. The present study was designed to screen~     several SNP by whole exome sequencing which evaluate the sepsis related snp site in order to~     be a new target for the treatment of sepsis.~   "
125850|NCT01920204|"~     Rationale: Patients with indolent or smoldering systemic mastocytosis can have severe~     disabling symptoms. Almost all patients have fatigue, a compromised quality of life,~     hampering normal functioning. Because this form of mastocytosis is not considered~     life-threatening, mast cell eradication has never been applied and patients receive only~     symptomatic therapy with histamine blockers. Midostaurin, a c-KIT inhibitor has shown~     activity regarding symptom control and decrease of malignant mast cells in patients with~     aggressive systemic mastocytosis (ASM) or mast cell leukemia~   "
125851|NCT01920191|"~     RATIONALE : IMA 950 is multi tumour-associated peptides (TUMAPs) vaccine, these peptides have~     been identified on primary glioblastoma multiforme (GBM) cells. Poly-ICLC is a potent vaccine~     adjuvant with broad innate and adaptive immune enhancing effects. IMA 950 and Poly-ICLC will~     be administered to patients alongside standard primary therapy for glioblastoma. This~     includes the alkylating drug temozolomide (TMZ). Effective vaccine-induced immune responses~     associated with prolonged survival have been observed in glioblastoma patients during TMZ~     adjuvant therapy, suggesting a possible synergistic effect. A second component of~     glioblastoma standard treatment is external beam irradiation of the tumor site post-surgery.~     As a side effect, potentially beneficial tumor-infiltrating immune cells may also be killed~     by radiation. However, the combination of radiation with immunotherapy has been suggested to~     be favorable both in pre-clinical models.~   "
125852|NCT01920178|"~     The purpose of this study is to assess the clinical efficacy and safety of the PinPointe Foot~     Laser device for the treatment of patients with onychomycosis who have been previously~     treated with oral Terbinafine and failed.~   "
125856|NCT01920126|"~     The purpose of study is to test whether perioperative sodium bicarbonate infusion can prevent~     acute kidney injury following open heart surgery in infective endocarditis patients.~   "
125857|NCT01920113|"~     Adequate, safe sedation is essential for Endoscopic submucosal dissection. Dexmedetomidine is~     a potent and selective a2-adrenoceptor agonist used for sedative and analgesic effects, but~     it is limited to use alone. The investigators designed this study to compare the effect and~     safety of two sedatives, dexmedetomidine and propofol in Endoscopic Submucosal Dissection~     (ESD), when sufficient analgesia-remifentanil is administered all throughout the procedure.~   "
125858|NCT01920100|"~     This project is based on a three-year program that aims to improve the knowledge of the~     socioeconomic consequences of dementia in Norway. By including patients with and without~     dementia in four different cohorts (from nursing homes, from memory clinics, home-dwelling~     persons with dementia and elderly persons without dementia), the project's aim is to describe~     tha course of dementia, the economical cost of dementia and to look into possible risk~     factors for dementia.~   "
125859|NCT01920087|"~     The purpose of the study is to test the efficacy of ATNC05 in the treatment of Atypical~     Facial Pain (AFP), also known as Persistent Idiopathic Facial Pain (PIFP). This research~     project targets patients with chronic constant facial pain and excludes patients with~     primarily paroxysmal pain.~   "
125860|NCT01920074|"~     RECTIV® is an ointment containing 0.4% nitroglycerin (NTG) for the treatment of moderate to~     severe pain associated with chronic anal fissure approved in June 2011 by the US Food and~     Drug Administration (FDA) for adults. The purpose of this study is to assess the safety,~     pharmacokinetics, and exploratory efficacy of RECTIV® in adolescents~   "
125861|NCT01920061|"~     This study will evaluate PF-05212384 (gedatolisib) PI3K/mTOR inhibitor)) in combination with~     either docetaxel, cisplatin or dacomitinib in select advanced solid tumors. The study will~     assess the safety, pharmacokinetics and pharmacodynamics of these combinations in patients~     with advanced cancer in order to determine the maximum tolerated dose in each combination.~     The cisplatin combination expansion portion will evaluate the anti tumor activity of PF~     05212384 plus cisplatin in patients with TNBC in 2 separate Arms (Arm 1 and Arm 2).~   "
125862|NCT01920048|"~     This study will assess whether percutaneous coronary intervention (angioplasty of the heart~     arteries) can improve survival and reduce hospitalization in patients with heart failure due~     to coronary disease, who have been treated with the best contemporary medical therapy.~   "
125863|NCT01920035|"~     Localized cooling/hypothermia using the UroCool System during robotic-assisted radical~     prostatectomy (RARP) surgery results in an improved overall return to continence, (defined as~     not wearing any protective urinary pads), compared with standard of care in men presenting~     for RARP.~   "
125864|NCT01920022|"~     Women having abortions are at high risk for subsequent unintended pregnancy and repeat~     abortion. Clearly, encouraging contraceptive use after abortion is a high priority. Long~     acting reversible contraceptives (LARCs, Implants and intrauterine contraception) are the~     most effective methods to help women avoid a repeat unwanted pregnancy and abortion. Studies~     in surgical abortion patients, show that quickstart of a LARC - i.e., inserting it during~     the surgical procedure - is associated with substantially greater use of that method six~     months later than requiring women to return later to get the device. However, today a~     majority of women chose medical abortion. The clinical routine is to insert LARCs at the~     follow up 2 to 3 weeks after the abortion treatment. Frequently women choose to do part of~     the abortion treatment at home and do not return for a follow up. Thus, the possibility to~     quick start a contraceptive method in medical abortion would be a major advantage especially~     if this could be done at the time of administration of mifepristone.~   "
125865|NCT01920009|"~     Introduction:~      In the United Kingdom(UK), about 838,000 men and 394,000 women have had a myocardial~     infarction (MI) and will need secondary prevention medications. Longterm adherence to~     secondary prevention therapies remains poor, nonadherence to medication in MI patients ranges~     from 13-60%(1). Studies show that approximately one fourth of cardiac patients do not refill~     their cardiac medications (2). Strategies to tackle the burden of non adherence could involve~     pharmacy care and The New Medicine Service (which is a service provided by community~     pharmacists to help patients on long term medications for chronic diseases) with a~     motivational interview incorporated as part of the counselling session of a community~     pharmacist. Communication of health providers with patients and between health providers~     could also be an important strategy to improve adherence.~      Cardiovascular disease is high in all ethnic groups as well as in the general population;~     however it is the South Asians who have the highest prevalence of coronary heart disease~     (CHD) (3). In addition, South Asians develop CHD at a younger age, often before the age of 40~     years (3).~      Aim of this study:~      This study is to investigate the feasibility and potential impact of a pharmacy care~     intervention involving motivational interviews and referral to the New Medicine Service in~     coronary heart disease patients on adherence to secondary prevention medication and on~     outcomes of coronary heart disease.~      Method:~      The study is designed as a prospective, controlled feasibility/pilot, intervention study. The~     study has two phases.~      In the intervention phase a total of 200 coronary heart disease patients discharged from the~     London Chest Hospital will be enrolled into the study and followed up for one year.~     Pharmacies from up to six London Boroughs will be invited to take place in the study.~     Pharmacies will be randomised using a table of random numbers into intervention site or~     control site. The pharmacists working in the intervention pharmacies will be invited for~     training on the delivery of the intervention and on motivational interviewing. The~     intervention will be performed by community pharmacists. Recruitment of patients will take~     place in the hospital. In the interview phase 20 patients from South Asian backgrounds will~     be invited for a telephone interview to study the effect of their beliefs and cultural~     backgrounds in regards to their adherence to cardiac medication.~      Outcome measures:~      The primary outcome measure is self report adherence with coronary artery disease medication~     employing a standard validated measure. Secondary outcomes are blood pressure and LDL-C (low~     density lipoprotein cholesterol) in addition to data regarding the feasibility of the~     intervention.~      Analysis:~      Both quantitative and qualitative data analysis will be performed.~   "
125866|NCT01919996|"~     This Post-Authorization Safety Study (PASS) is intended to fulfill a regulatory~     post-marketing requirement to provide data regarding visual abilities in children taking~     azithromycin (immediate-release formulation) for acute pharyngitis/tonsillitis. The primary~     objective of the study is to examine the incidence of clinically significant worsening in any~     of the following ophthalmic exams: best corrected visual acuity (distance), color vision,~     Amsler grid testing, anterior segment biomicroscopy, and fundus examination, in a group of~     approximately 30 pediatric patients taking azithromycin oral solution for treatment of an~     authorized indication of use (pharyngitis/ tonsillitis).~   "
125881|NCT01919801|"~     This study is being conducted to compare the safety and efficacy of icatibant with placebo in~     the treatment for Angiotensin-Converting Enzyme Inhibitor (ACE-I)-Induced Angioedema in~     Adults.~   "
125989|NCT01918397|"~     Multi-drug-resistant tuberculosis (MDR-TB) affects nearly 600,000 persons each year around~     the world. This type of tuberculosis is very difficult to treat, and many patients die from~     it. Drugs of the fluoroquinolone class are very important for treating MDR-TB, but the best~     dose of one of the most effective fluoroquinolones, levofloxacin, is not known. This~     application proposes a study to determine the best dose of levofloxacin to use in treating~     MDR-TB. 120 patients will receive their usual treatment, plus levofloxacin at one of four~     doses. The study will be performed in Peru and in South Africa, where MDR-TB is common.~   "
125867|NCT01919983|"~     Despite pharmacologic advances for the treatment of congestive heart failure (HF), sudden~     cardiac death (SCD) and pump failure remain the leading causes of mortality in patients with~     HF. Although, SCD is poorly understood, implantable cardiac defibrillators (ICD) have been~     shown to be an effective, but costly therapy in preventing SCD. At present, left ventricular~     systolic dysfunction is our best independent predictor of SCD, but only moderately predicts~     those patients who will eventually benefit from the placement of an ICD and, in most cases,~     left ventricular (LV) systolic dysfunction is a non-modifiable risk factor once acquired. As~     a result, there exists an intensive search for biomarkers that could improve the prediction~     of SCD and have the potential for risk factor modification.~      Experimental and clinical evidence has established that inflammation plays a critical role in~     stable coronary disease, plaque rupture, acute myocardial infarction, heart failure, and SCD.~     Studies at our institution have demonstrated that elevated levels of hsCRP and Interleukin-6~     are predictive of arrhythmic SCD; however, the mechanism of causing this increased risk is~     unclear.~      Another well-known risk factor for SCD is abnormal sympathetic innervation. The most robust~     clinical test of sympathetic innervation to date is Iodine-123 Metaiodobenzylguanidine (MIBG)~     imaging with gamma scintigraphy. MIBG imaging has emerged as one of our strongest predictors~     of SCD by detecting sympathetic nervous system abnormalities in patients with HF. Preclinical~     and clinical evidence suggests that myocardial inflammation adversely affects myocardial~     innervation.~      Based on these findings, the investigators hypothesize that elevated levels of inflammatory~     biomarkers are associated with abnormal sympathetic innervation as measured by MIBG imaging.~     The investigators aim to establish the strength of this association. This proposal will~     leverage unique access to the largest, most extensively phenotyped cohort of patients who~     have undergone ICD implantation for primary prevention of SCD, the PRospective Observational~     Study of the ICD in SCD, (PROSE-ICD).~   "
125868|NCT01919970|"~     Autism spectrum disorders affect as many as 1 out of 88 children and are related to~     significant impairment in social, adaptive, and school functioning. Co-occurring conditions,~     such as anxiety, are common and may cause substantial distress and impairment beyond that~     caused by the autism diagnosis. Accordingly, we are proposing a randomized controlled trial~     to examine the effectiveness of a form of cognitive-behavioral therapy relative to treatment~     as usual (TAU) in 50 youth ages 6-12 with autism spectrum disorders and comorbid anxiety.~   "
125869|NCT01919957|"~     This study has two purposes: firstly, a better understanding of the neurobiological processes~     underlying episodic memory and, secondly, the development of useful clinical applications for~     epileptic patients, in particular the prediction of postoperative memory deficits and the~     development of cognitive remediation therapies.~      Memory performances during a fMRI experiment will be assessed in controls and epileptic~     patients before and after the surgery.~   "
125870|NCT01919944|"~     The purpose of this study is to test whether VLY-686 can prevent or reduce the itch and~     dermatological reaction observed after healthy volunteers are injected with Substance P in~     comparison with placebo.~   "
125871|NCT01919931|"~     Candida albicans is one of the most common nosocomial infection and the onset relies on the~     host immune status. The purpose of this study is to determine the immunological profile of~     patients infected with Candida albicans, that could ideally lead to a strategy to identify~     patients who could benefit from prophylaxis.~   "
125872|NCT01919918|"~     The purpose of the study is to find out more about the mechanism by which neural feedback~     from the working muscle affects the development of central fatigue during exercise. Subjects~     with chronic heart failure (HF) and healthy subject counterparts will be tested to determine~     the mechanisms accounting for the premature fatigue characterizing HF patients during~     physical activity.~   "
125873|NCT01919905|"~     The purpose of this study is to evaluate the effect of heat on the bioavailability of vitamin~     D in industrially fortified mozzarella cheese baked with pizza.~   "
125874|NCT01919892|"~     Thirty subjects with a DSM-IV (Diagnostic and Statistical Manual, fourth version)diagnosis of~     BPD during a depressive or hypomanic episode will be divided in two groups according to age~     and time of illness. All patients will receive lithium (flexible therapeutic dose) for 6~     weeks and improvement will be evaluated weekly using depression and mania rating scales; this~     study also objectives to identify state/trait markers and predictors of response.~   "
125875|NCT01919879|"~     This is a multicentric, phase II and open label study.75 patients are expected to be~     randomized in 35 centers. The main objective is to assess the efficacy and safety of Afatinib~     -cetuximab combo versus cetuximab alone in treatment of patients with refractory wtKRAS~     metastatic colorectal cancer.~   "
125876|NCT01919866|"~     Feasibility and toxicity of haploidentical transplantation of CD3/CD19 depleted stem cells in~     combination with a toxicity reduced conditioning regimen or with standard conditioning~     regimens according to underlying disease.~   "
125877|NCT01919853|"~     The purpose of this study is to compare the effects of Mindfulness-Based Stress Reduction~     (MBSR) to an attention control psycho-educational support group in treating cancer-related~     fatigue (CRF) in early-stage (0-III) post-treatment cancer survivors with~     clinically-significant CRF. The study will collect, store, and later analyze blood and urine~     samples for several biomarkers that may be linked to persistent CRF in cancer survivors.~   "
125878|NCT01919840|"~     Main objective:~      Determine whether by introducing thromboelastograph, the investigators reduced the number of~     packed red cells received by each patient (median) compared to the usual protocol, in which~     the indication for transfusion is based on laboratory tests: Prothrombin time, time activated~     partial thromboplastin time, thrombin, reptilase, fibrinogen and platelet contage.~      Design:~      Prospective randomized controlled trial and single blinded.~      Disease or disorder under study:~      Study of coagulopathy in patients undergoing cardiac surgery with cardiopulmonary bypass~     (CPB).~      Primary endpoint:~      median transfusion of packed red blood cells per patient. Study population Male and female~     patients over 18 years undergoing cardiac surgery with cardiopulmonary bypass to bleed~     excessively.~      Duration of treatment:~      The coagulation monitoring methods tested are made from protamine administration to CEC~     output if a) the patient bleeds diffusely, or b) from arrival in the unit if not satisfied~     critics a) bleed excessively drains and until the patient stops bleeding (debit drains <a~     150ml / h).~   "
125879|NCT01919827|"~     Clinical Trial Phase I, open, multicentric, non randomized, study with escalating doses, to~     evaluate the safety and feasibility of treatment with mesenchymal stem cells in patients with~     diagnosis of idiopathic pulmonary fibrosis.~      Primary endpoint: The aim is to evaluate the safety and feasibility of the endobronchial~     administration of mesenchymal autolog stem cells derived from bone marrow (BM-MSC)in patients~     with mild-to-moderate idiopathic pulmonary fibrosis.~      Secondary endpoint:Assess the possible effect of the infusion of BM-MSC in stopping the fall~     of pulmonary function in patients with mild-to-moderate idiopathic pulmonary fibrosis.~   "
125880|NCT01919814|"~     The purpose of the study is to determine whether Appethyl™, made from spinach, will reduce~     appetite and hunger given on the same day of testing.~   "
125882|NCT01919788|"~     Diabetes mellitus type I (DMI) is characterized by lack of endogenous insulin and these~     patients are 100% dependent on insulin substitution to survive. Diabetes mellitus type II~     (DMII) is characterized by reduced insulin sensitivity and sometimes also reduced insulin~     production, thus patients with DMII might also be dependent on insulin substitution.~      Insulin is produced in- and secreted from the pancreas when blood glucose concentration rises~     during- and after a meal. Insulin increases cellular uptake of glucose leading to lower blood~     glucose concentration. Substitution with insulin is/can be necessary in DM, but at the same~     time it induces the risk of hypoglycemia. This makes treatment with insulin a balancing act~     between hyper- and hypoglycemia.~      A hypoglycemic episode is a dreaded consequence of insulin overdosing, and also a very~     frequent reason for hospital admission in patients with DM. Examples of hypoglycemic symptoms~     may be; shaking, a sense of hunger, sweating, irritability progressing to lack of relevant~     cerebral responses and eventually coma, convulsions and possibly death. People with diabetes~     lose the ability to sense of low blood glucose with time, because of a lack of appropriate~     counter-regulatory responses, hereby increasing the risk of severe hypoglycemia.~     Understanding normal physiologic counter regulatory mechanisms during hypoglycemia is of~     major importance to patients with DM and has the potential to change medical treatment in~     diabetes, to reduce the risk of hypoglycemia.~      Hypothesis: Hypoglycemia counteracts insulin signaling via hormone-dependent intracellular~     counter-regulatory mechanisms, involving phosphorylation of specific signaling proteins.~      Aim: To define counter-regulatory mechanisms in muscle- and fat tissue during hypoglycemia,~     and to investigate the effect of insulin on lipid metabolism in healthy- and type I diabetic~     subjects.~   "
125883|NCT01919775|"~     To clarify whether amnesia after treatment of anterior communicating aneurysm (ACoA)is~     related to infarcts caused by occlusion or damage of the perforating artery of the ACoA, we~     used 3.0-T 3D high resolution MR imaging to identify and localize infarcts in patients with~     amnesia following treatment of ACoA aneurysm.~   "
125884|NCT01919762|"~     To assure the uniform collection, handling, storage and transport of patient whole blood~     specimens and associated information to support validation of the T2 Bacteremia Assay.~   "
125885|NCT01919749|"~     This study will use proteomic and genomic profiling to analyze tumor tissue to see if~     treatment selected by this analysis will benefit patients.~   "
125886|NCT01919736|"~     The objective of this project is to determine the effects of gait-retraining on articular~     cartilage composition, gait mechanics, pain and function in persons with mild to moderate~     knee osteoarthritis (OA).~   "
125887|NCT01919723|"~     This purpose of this study is to measure platelet response to ticagrelor and eptifibatide~     bolus-only compared with ticagrelor and eptifibatide bolus plus 2-hour infusion administrated~     after cardiac catheterization in patients undergoing non-emergent percutaneous coronary~     intervention.~   "
125888|NCT01919710|"~     Safety and efficacy studies of rHSA/GCSF fusion protein for injection in treatment of~     neutropenia induced by chemotherapy of cancer patients.~   "
125889|NCT01919697|"~     This is a multi-center, open-label, 52-week safety and tolerability study of plecanatide in~     patients with Chronic Idiopathic Constipation (CIC).~   "
125890|NCT01919684|"~     This study is designed to evaluate the safety and tolerability of a range of single oral~     doses of LGD-6972 in healthy subjects. Additionally, the study will characterize the~     Pharmacokinetic profile in healthy subjects under fed and fasted conditions and in subjects~     with Type 2 Diabetes Mellitus under fasted conditions.~   "
125891|NCT01919671|"~     The purpose of this study is to assess the effects in improving life self-care ability of~     stroke patients after taking Tongxinluo Capsule(within 72 hours after onset) versus Placebos~     for 90 days.~   "
125892|NCT01919658|"~     The primary objective of the study is to compare motor strength in knee extension between two~     groups of patients. One group receiving a proximal thigh block of the femoral nerve, and one~     receiving a distal thigh block of the saphenous nerve. The secondary objective is to compare~     the pain relief and functional outcomes in these two groups.~   "
125893|NCT01919645|"~     Physical exercise programs are effective and safe for the improvement of the sleep efficiency~     in patients with Rheumatoid Arthritis.~   "
125894|NCT01919632|"~     Background: The impact of demographic changes on workplace has increased the importance of~     effective occupational preventive health programs. The primary goal of these programs is the~     improvement of overall health status (and therefore increase productivity and decrease~     healthcare costs) of the increasingly older workforce through positive lifestyle behavior~     change.~      A one- year preventive health behavior-change program for the employees of the company~     British Petrol (BP) shall be scientifically evaluated. The initial stage of the program~     consists of a health-behavior seminar and six weeks (twice a week for 90 minutes) of~     supervised endurance exercise (i.e. jogging, nordic walking, cycling or swimming) in groups.~     In the second phase of the program, the participants receive a recommendation to continue~     exercise regularly unsupervised for one year, and receive monthly supervised exercise~     training sessions. Clinical check-ups are performed at baseline (V1) at three months (V2) and~     at 12 months (V3).~   "
125895|NCT01919619|"~     The goal of this clinical research study is to study the safety of REVLIMID® (lenalidomide)~     when given with YERVOY® (ipilimumab) after a stem cell transplant. Researchers also want to~     find out if lenalidomide given with ipilimumab may help to control leukemia, lymphoma, and~     multiple myeloma.~   "
125896|NCT01919606|"~     The primary objective of this study is to determine the optimal of two different volumes of~     EXPAREL 266 mg when administered via infiltration into the transversus abdominis plane (TAP)~     for prolonged postoperative analgesia in subjects undergoing open total abdominal~     hysterectomy.~   "
125897|NCT01919593|"~     To evaluate the efficacy of 2% chlorhexidine gluconate in 70% alcohol compared with 10%~     povidone iodine in reducing blood culture contamination in pediatric patients.~   "
125898|NCT01919580|"~     Study on the carcinogenesis of Gα12 in oral cancer, and chemopreventive possibility for the~     treatment of oral cancer using Ga12 inhibitor.~   "
125899|NCT01919567|"~     Study on the Carcinogenesis of SOX-9 in Oral Cancer, and Chemopreventive Possibility for the~     Treatment of Oral Cancer Using SOX-9 Inhibitor.~   "
125900|NCT01919554|"~     The purpose of this study is to investigate the safety and tolerability of different doses of~     sublingual tablets of house dust mite (HDM) allergen extracts in adolescents with house dust~     mite-associated allergic rhinitis.~   "
125901|NCT01919541|"~     The investigators hypothesize that individuals who receive a personalized 4 week~     prehabilitation program consisting of exercise and nutrition counselling with post-workout~     whey protein supplementation will show, before colorectal surgery, improved insulin~     sensitivity, inflammatory profile, and substrate utilization compared to baseline measures.~     These results will translate into a higher functional capacity before surgery as demonstrated~     by an improvement in 6-minute walking test.~   "
125902|NCT01919528|"~     The central venous catheterization (central line placement) is the common procedure performed~     in the intensive care unit. This procedure is performed by percutaneous puncture of so called~     'the central vein' and than advancement of the catheter over the guidewire (Seldinger~     technique). The tip of the catheter is left in the superior vena cava in the vicinity of the~     right atrium of the heart. Central veins are large veins in the human body passing the blood~     into the heart.~      Typical, clinical indications for the central line placement in the intensive care unit are~     hemodynamic monitoring, volume monitoring, administration of medications, long-term total~     parenteral nutrition, access for renal replacement therapy, difficult peripheral~     catheterization.~      There are two methods of the central venous catheterization in terms of visualization. First~     and older is the blind technique. The operator is locating the anatomical landmarks and then~     performing the entire procedure blindly by percutaneous puncture. This is called the landmark~     technique. Second and new is the ultrasound-guided technique. The operator is locating the~     vein using ultrasonography and then performing the entire procedure under ultrasonographic~     visualization. The real time ultrasound-guided central venous catheterization became the~     standard of care in recent years mainly because of safety issues (is regarded as safer than~     landmark technique)~      The catheterization of the axillary vein is not popular procedure in daily clinical practice.~     But it can be reasonable and safe alternative to others, typically performed central venous~     catheterizations like the internal jugular vein and the subclavian vein catheterizations.~      The main intention of this study is to assess usefulness and safety of the real time~     ultrasound guided axillary vein catheterization in mechanically ventilated patients admitted~     to the intensive care unit.~   "
125903|NCT01919515|"~     The hypothesis to be tested is that NuSmile ZR esthetic primary molar crowns perform~     similarly to an established Stainless Steel primary molar crown (3M ESPE) for restoration of~     primary molar teeth.~   "
125904|NCT01919502|"~     Given the potential of semi-quantitative pregnancy tests as part of assisted fertility care,~     the investigators would like to document the feasibility and acceptability of a~     semi-quantitative pregnancy test as an adjunct to or replacement of current monitoring~     protocols to offer women and health care providers a new choice of diagnostic tools to~     confirm early pregnancy. The pilot will help us to better understand how this tool~     complements existing monitoring protocols. If a suitable addition or replacement to repeat~     blood draws for serum hCG assessment, the SQPT could also contribute to efforts to make~     assisted fertility treatments more patient-friendly. This study seeks to test this innovation~     by asking women assigned to perform a Quanti5 Multilevel hCG Pregnancy Test (Athenium~     Pharmaceuticals, LLC, Nashville, TN) at home on a weekly basis for up to 4 weeks after egg~     retrieval/embryo transfer or intrauterine insemination.~      The investigators hypothesize that the test, which can be used at home by women, will provide~     confirmation of the presence of a pregnancy compared with standard serum hCG testing because~     1) it has sensitivity and specificity that correlates well with serum testing, and 2) it can~     be used at home and thus earlier to determine presence of hCG.~   "
125905|NCT01919489|"~     High blood glucose levels in hospitalized patients with diabetes are associated with~     increased risk of medical complications and death. Improved glucose control with insulin~     injections may improve clinical outcome and prevent some of the hospital complications.~     Increasing evidence indicates that incretin-based agents are safe and effective for the~     hospital management of patients with type 2 diabetes (T2D).~      Liraglutide is a once-daily human glucagon-like peptide (GLP-1) analogue approved for the~     treatment of T2D. Liraglutide has been shown to lower blood glucose, stimulate endogenous~     insulin secretion, decrease plasma glucagon levels, inhibit gastric emptying, reduce food~     intake and body weight and improve ß-cell function when administered subcutaneously.~     Liraglutide increases insulin secretion in a glucose-dependent manner (i.e., only when plasma~     glucose levels are elevated), resulting in low-risk of hypoglycemia when used as monotherapy.~     When compared to insulin glargine therapy, the use of GLP-1 has resulted in comparable~     reduction in HbA1c level, lower rates of hypoglycemia and less weight gain. No prospective~     studies; however, have compared the efficacy and safety of liraglutide in the hospital~     setting or after hospital discharge.~      The primary objective is to compare the safety and efficacy of liraglutide (Victoza®) versus~     glargine insulin in combination to oral anti-diabetic agents (OADs: metformin, sulfonylureas,~     nateglinide, repaglinide or pioglitazone) on glycemic control after 26 weeks of treatment in~     medicine patients with T2D after hospital discharge.~   "
125906|NCT01919476|"~     Currently, about one third of all women entering pregnancy are obese. The prevalence of~     metabolic disorders during pregnancy has increased concurrently with the rise in maternal~     obesity. Although dietary interventions are used routinely to reduce metabolic disease in~     non-pregnant obese individuals, no specific dietary advice is provided to obese, pregnant~     women unless they develop gestational diabetes mellitus. In this study, the investigators~     will specifically assess the effect of replacing dairy fats with almonds in a breakfast meal~     on the postprandial metabolic response. This cross-over, randomized control trial will~     examine the postprandial metabolic response to 0 or 2 oz of almonds in standardized test~     meals in pregnant Hispanic women with prepregnancy BMI between 25 and 40. Hispanics are at~     higher risk for gestational diabetes and the metabolic syndrome. The investigators~     hypothesize that consuming almonds in place of dairy fat reduces the glycemic response and~     improves the postprandial lipid profile in these high-risk women.~   "
125907|NCT01919463|"~     The primary aim of this study is~      - to explore the usefulness of abdominal compression on intubation.~      Other aims include~        1. to investigate the effectiveness and the efficacy of different manners of abdominal~          compression and to analysis the reasons of their success and failure~        2. to get the knowledge of the formation of colon loops and its frequency~        3. to clarify the impact of intubation with loops on adenoma detection rate~   "
125908|NCT01919450|"~     The purpose of this study is to evaluate the consistency of quantitative peak stress~     myocardial blood flow and myocardial blood flow reserve following a 10 second, 1 minute, 2~     minute or 4 minute delay in beginning the rubidium-82 infusion post-Lexiscan (regadenoson)~     injection. It is anticipated that there will be no or minimal difference between the four~     delay times.~   "
125909|NCT01919437|"~     The purpose of this study is to develop the technology infrastructure for a mobile Web-based~     cognitive and neuropsychological assessment of substance abusers, and to perform a pilot~     trial using neurocognitive tasks designed to demonstrate that our system is statistically~     comparable to current clinical practice.~      The primary hypotheses are that results collected using a web-based data collection platform~     will be comparable (but not necessarily equivalent) to data collected under controlled~     laboratory conditions, that methamphetamine (MA) dependent participants will have worsened~     neurocognitive performance compared to healthy volunteers, and the platform will be~     acceptable to participants.~   "
125910|NCT01919424|"~     This study will compare the methacholine PC20 of two different modern-delivery aerosol~     systems to determine if one may replace the other for use in clinical settings.~   "
125911|NCT01919411|"~     Surgeons commonly prescribe post operative prophylactic antibiotics after sinus surgery.~     There is minimal data to support this. The investigators' study will aim to demonstrate that~     patients' quality of life and rate of post operative infection is the same whether they~     receive or do not receive antibiotics post operatively. The investigators hypothesis is that~     the disease specific quality of life of patients taking post-operative antibiotics is not~     inferior to the quality of life of patients who do not take post-operative antibiotics, and~     the rate of post-operative infections are the same. The investigators' specific aim is to~     compare validated symptom scores between post-operative populations who are given or are not~     given antibiotics. Rates of infections in the first 10 days after surgery will be recorded.~     The investigators will also compare endoscopic grades of sinus cavities during the~     post-operative follow up exams as an additional outcome measure.~   "
125912|NCT01919398|"~     The primary purpose of this study is to assess the safety and tolerability of LY2940680 up to~     the global recommended dose in Japanese participants with advanced solid cancers.~   "
125913|NCT01919385|"~     This study will be conducted in a Clinical Research Center (CRC) setting and recruiting type~     1 diabetes that are currently using an insulin pump.~   "
125914|NCT01919372|"~     This project is based on the contribution that could offer a technological system for a~     continuous monitoring, individualized treatment of obesity and prevention of cardiometabolic~     complications in high risk population.~      The main objective of PREDIRCAM study is to evaluate the benefits obtained with the use in~     high cardiometabolic risk individuals of a telemedical platform integrating applications for~     monitoring and providing recommendations to improve lifestyle habits (diet and physical~     activity) in a healthier way.~      The study population are obese subjects (type I or II) aged between 25 and 65 years with a 12~     month follow-up. In this population it will be analysed the cost-effectiveness of a telemedic~     assistance with a technological system and its ability to modify lifestyle habits, reduce~     weight and cardiovascular risk associated parameters.~      Previously to the clinical implementation, a pilot study for testing the telemedical system~     will be made. Efficacy and security variables will be evaluated along the study.~   "
125915|NCT01919359|"~     Nutritional supplementation is more effective than placebo in the reduction of redness and~     bruising following facial ablative laser resurfacing treatments and following soft tissue~     filler injections to the lips and/or malar areas.~   "
125916|NCT01919346|"~     The purpose of this study is to evaluate the efficacy of Eculizumab in the prevention of~     Delayed Graft Function following deceased donor kidney transplantation. Based on experimental~     data and supportive observations in humans associating complement gene upregulation with~     ischemic reperfusion (IR) injury, it is hypothesized that C5 cleavage is a key step in the~     pathogenesis of ischemic reperfusion injury following transplantation. It is further~     hypothesized that Eculizumab, a humanized monoclonal antibody that blocks C5 cleavage in~     humans will be an effective prophylactic agent to prevent IR injury in high risk recipients.~     This trial is a prospective, randomized study to test the efficacy of eculizumab vs. placebo~     given once at the time of transplantation and once again 24 hours later in preventing delayed~     graft function in first adult recipients of deceased donor kidneys.~   "
125917|NCT01919333|"~     This aim of the study is to evaluate the impact of endometrioma and laparoscopic cystectomy~     on ovarian reserve as measured by serum antimullerian hormone and to study the different~     effects of levels of serum antimullerian hormone between laparoscopic cystectomy and the~     non-ovarian pelvic surgery.~   "
125918|NCT01919320|"~     Study Purpose~      The purpose of this PAS is to confirm that patients implanted with the temporary Total~     Artificial Heart (TAH-t) and supported with the Companion 2 Driver System have outcomes~     similar to those patients implanted with the TAH-t and supported with the CSS Console. The~     data collection mechanism for this study is the INTERMACS Registry.~      Study Objectives~      Primary Objective 1:~      To confirm that patients implanted with the TAH-t and supported by the Companion 2 Driver~     System have outcomes similar to those patients implanted with the TAH-t and supported by the~     CSS Console.~      Primary Objective 2:~      To compare positive outcome rates for all TAH-t patients entered in the Intermacs Registry~     initially supported with the Companion 2 Driver System to positive outcome rates for all~     TAH-t patients initially supported by the CSS Console.~      Primary Objective 3:~      To review additional data (patient survival, adverse event rates and bridge to transplant~     rates) to support the conclusion that the use of an artificial heart is reasonable and~     necessary for the treatment of irreversible biventricular failure in Medicare/Medicaid~     patients.~      Secondary Objective:~        -  To evaluate the incidence of adverse events (AEs). The AEs will follow the definitions~          in the INTERMACS Registry.~      Study Hypothesis: Primary Objective 1 The primary hypothesis is that the positive outcome~     rate (defined as transplant , transfer to the Freedom Driver System support, or continuing on~     implant driver support, whichever occurs first; assessed at three and six months~     post-implant) for patients supported with the Companion 2 Driver System is non-inferior to~     the survival rate for patients supported with the Circulatory Support System (CSS) Console.~      Data Collection The data will be collected as defined in the INTERMACS Protocol and the~     patients will be followed at one week, one month, three months and six months or until their~     study endpoint is reached.~      Data Analysis~      Primary Objective 1:~      Data analysis will provide descriptive statistics on enrollment, adverse events, and outcomes~     for TAH-t patients who were implanted while supported with the Companion 2 Driver System~     compared to TAH-t patients who were implanted while supported with the CSS Console.~      Primary Objective 2:~      Data analysis will provide descriptive statistics on enrollment, adverse events, and outcomes~     for all TAH-t patients enrolled in the INTERMACS Registry.~   "
125919|NCT01919307|"~     This feasibility study will determine the tolerability of auricular acupuncture, compliance~     with self-reported seizure tracking, and the quality of a proposed sham acupuncture protocol~     to inform the design of a large, multi-center, placebo-controlled, double-blind study to~     demonstrate the therapeutic effect of auricular acupuncture for the treatment of~     Non-Epileptic Seizures.~   "
125920|NCT01919294|"~     The main research questions are: In hypogonadal men with non-alcoholic steatohepatitis~     (NASH), does Testosterone Replacement Therapy (TRT), given for 12 months~        1. improve severity of steatosis on liver biopsy (Primary Question)?~        2. improve severity of associated steatohepatitis on liver biopsy?~        3. reduce liver fat content as assessed by proton Magnetic Resonance Spectroscopy (1H-MRS)?~      The work proposed here is an open pilot study of 10 patients, the main aim of which is to~     assess the effect size of TRT in regard to these end points (regarding which there are no~     published data), thereby allowing power calculations for a more definitive phase II trial.~     Other aims would be assessing recruitment and consent rates, which would also inform the~     design of the larger study.~   "
125921|NCT01919281|"~     The aim is to investigate whether strength training or high intensity interval training is~     effective in improving insulin sensitivity, cardiovascular outcomes, body composition and~     reproductive outcomes in women with Polycystic Ovary Syndrome (PCOS).~      Few studies have examined the effect of strength training alone on insulin sensitivity,~     reproductive outcomes and body composition in women with PCOS. Most previous studies on~     aerobic exercise in PCOS have applied moderate exercise intensity.~   "
125922|NCT01919268|"~     This study aims to evaluate the effectiveness of the addition of the interferential current~     to Pilates method exercises in the treatment of 148 patients with chronic nonspecific low~     back pain.~   "
125923|NCT01919255|"~     The purpose of this study to bowel cleansing evaluation of mixed two other type bowel~     preparation drug(PICOLIGHT plus COOLPREP, PICOLIGHT plus CLICOLON).~   "
125924|NCT01919242|"~     Gastric cancer is still one of the main health care issue and gastrectomy with lymph node~     dissection is the only chance to be cure. Even though the development and standardization of~     gastric cancer surgery, the morbidity of gastric cancer surgery was reported around 20% with~     less than 1% of mortality in East. In contrast, around 40% of morbidity and 10% of mortality~     was reported in West. There has been several indexes which can define the complications after~     surgery, but adapting it into clinical practice is sometimes difficult due to the~     heterogeneous opinion between surgeons. Thus for clear defining the complications after~     surgery, consensus between many surgeons and prospective cohort study is necessary. The~     purpose of this study is collecting the complications data after gastric cancer surgery and~     defining it with every week meeting by at least 6 or more surgeons' discussion.~   "
125925|NCT01919229|"~     This is a multi-center, open-label Phase II randomized pre-surgical pharmacodynamics study.~   "
125926|NCT01919216|"~     The placebo effect represents a potent treatment for MDD—placebo response in acute randomized~     controlled trials (RCTs) of antidepressant medications averages 30%, and meta-analyses have~     estimated the proportion of medication response attributable to placebo to be 50-75%. Patient~     expectancy is the mechanism of placebo effects in antidepressant RCTs and has been positively~     associated with medication response. Determining how expectancy alters the course of MDD~     could lead to methods of optimizing placebo effects and improving the treatment of MDD. In~     addition, investigating the neurobiology of placebo effects has the potential to elucidate~     the pathophysiology of MDD and the mechanisms of action of antidepressant treatments. Brain~     regions implicated in expectancy and placebo effects comprise prefrontal cortical (PFC)~     areas, amygdala, insular cortex, rostral anterior cingulate cortex (rACC), and dopaminergic~     reward pathways in the striatum. Pathological decreases in PFC and striatal function,~     increases in limbic activity, and disordered connectivity between these regions have all been~     observed in MDD, and the rostral and dorsal ACC have been repeatedly linked to antidepressant~     treatment response.~      Therefore, studying placebo effects offers a window into the functioning of the neural~     circuits that are disturbed in MDD and improve with effective treatment. The goals of this~     study are to determine whether expectancy affects the outcome of antidepressant~     pharmacotherapy and to investigate the neural mechanisms of expectancy effects. These will be~     accomplished by conducting a clinical trial randomizing adult outpatients with MDD to 8 weeks~     of treatment in high vs. low expectancy conditions. The high expectancy condition will be~     open administration of citalopram, while the low expectancy condition will be~     placebo-controlled administration of citalopram. The neural mechanisms of expectancy will be~     determined using functional Magnetic Resonance Imaging (fMRI) paradigms to investigate~     treatment activation differences in brain regions associated with placebo effects and MDD.~   "
125927|NCT01919203|"~     This research attempts to find the optimum dose of remifentanil that can prevent the~     unnecessary responses such as coughing, gagging, and movement when LMA is inserted during~     sevoflurane induction in pediatric patients.~   "
125928|NCT01919190|"~     The purpose of this prospective, blinded assessor, randomized trial is to assess opioid use~     and patient-reported outcomes of EXPAREL as a foundation in postsurgical pain therapy in~     Transversus Abdominis Plane (TAP) infiltration in lower abdominal surgical procedures.~   "
125929|NCT01919177|"~     The main objective is to test the hypothesis that inorganic nitrate supplementation will: (1)~     Improve exercise efficiency and performance; (2) Enhance the systemic vasodilator reserve~     during exercise and specifically, the vasodilator response in exercising muscle; (3) Reduce~     arterial wave reflections and arterial load; (4) Improve skeletal muscle mitochondrial~     function in subjects with heart failure with preserved ejection fraction.~   "
125930|NCT01919164|"~     This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 2~     trial of AS902330 administered intra-articularly in subjects with primary osteoarthritis of~     the knee and Kellgren-Lawrence Grade 2 or 3. The trial is intended to investigate the~     efficacy and safety of different intra articular dosages of AS902330 (Sprifermin) in these~     individuals.~   "
125931|NCT01919151|"~     Prognostic and predictive value of assessing the patients micrometastasis status in blood and~     bone marrow when diagnosed GI cancer. 2 different patient subgroups are currently studied,~     patients with cancer of the pancreas and patients with liver metastasis secondary to~     colorectal cancer.~      Our hypothesis is that patients with detective circulating tumor cells in the blood or~     disseminated tumour cells in their bone marrow at diagnosis have a more advanced disease than~     negative patients. This information may be of therapeutic interest.~   "
125932|NCT01919138|"~     Retrospective review of the outcomes of severe sepsis patients in Surgical Intensive Care~     Unit of National Taiwan University Hospital from January 1, 2009 to December 31, 2011.~   "
125933|NCT01919125|"~     The purpose of this study is to evaluate the pharmacokinetics (PK) and safety and~     tolerability of single-dose administration of IDX719 in participants with normal hepatic~     function and participants with varying degrees of hepatic impairment.~   "
125934|NCT01919112|"~     Swallowing difficulties are common after a stroke and can lead to serious complications like~     pneumonia and malnutrition. Unfortunately, there are no effective treatment for improving~     swallowing in stroke patients.~      Previous investigations have shown that recovery of swallowing functions occurs from~     reorganization (rewiring) of the non-involved cerebral hemisphere. In this study, we~     propose to investigate a new intervention, which combines, swallowing exercises with brain~     stimulation targeted to the non-involved cerebral hemisphere, using low intensity current in~     acute. We will only be enrolling hospitalized stroke patients. We plan to assess the safety~     of this technique in this patient population and also assess its effect on improving~     swallowing functions and swallowing physiology. During this time trial participants will~     undergo standardized swallowing and neurological assessments as well as brain MRI scans.~   "
125935|NCT01919099|"~     Background:~      - The National Institutes of Health (NIH) performs up to 100 allogenic stem cell transplants~     (allo-HSCT) each year. Many studies already look at different problems that can follow a~     transplant. But there are many types of transplants, diseases, responses, and treatments. An~     organized study of this information could help researchers learn more about how often~     transplant complications occur and what problems they cause. It could also lead to ideas for~     future research. This study will focus on complications thought to be the most significant.~      Objectives:~      - To gather information on the complications that may occur after an allo-HSCT.~      Eligibility:~      - People over 2 years of age currently enrolled in an allo-HSCT study at NIH.~      Design:~        -  Visits for this study will be scheduled along with primary study visits. The number of~          visits will depend on the primary study schedule.~        -  At each visit, participants will answer questions and take physical exams.~        -  The same questions and physical exams will continue for as long as they are in the~          primary study.~        -  In between visits, researchers might call participants to discuss their health. They may~          also discuss the cases with the primary study doctors and other doctors. Primary~          transplant study doctors will make treatment decisions.~        -  When participation in the primary transplant study ends, participation in this study~          will also end.~   "
125936|NCT01919086|"~     The purpose of this study is to see if researchers could get the same good results with less~     toxicity by using this new approach.~      We already know that the three drugs bortezomib, lenalidomide, and dexamethasone given~     together at the same time are effective. Most physicians therefore treat patients with~     multiple myeloma with the 3 drug combination. However, the researchers also know that the~     three drugs given together result in more side effects than when only 2 drugs (bortezomib and~     dexamethasone or lenalidomide and dexamethasone) are given. The researchers believe that all~     patients may not necessarily need the three drugs to have good results. In this study, the~     researchers will first treat your disease with bortezomib and dexamethasone. If the disease~     is not well controlled with these 2 drugs, only then the third drug, lenalidomide, will be~     added. By using this sequential approach we may reach the same good results with fewer side~     effects.~   "
125937|NCT01919073|"~     The purpose of this study is to test the intervention using a more rigorous randomized~     controlled trial design in order to demonstrate its efficacy compared to a wait-list control,~     thus ensuring that change in behavior does not occur due to the passage of time alone. Using~     this design will also allow us to improve upon our prior clinical research by facilitating~     obtainment of post-treatment and follow-up data (as families in the clinical-only service~     stop attending treatment when behavior improves, and have often not followed-up for booster~     sessions or measure completion).~   "
125938|NCT01919060|"~     The purpose of the study is to investigate acute non-mechanical lower digestive tract~     disorders should distinguish whether colonic lesions or not in critically ill patients~   "
125939|NCT01919047|"~     This study is to determine the following information.~        1. The occurrence of adverse drug reactions in clinical settings.~        2. Factors potentially impacting safety, effectiveness, and other aspects.~   "
125940|NCT01919034|"~     According to above basic findings, it is important to confirm those results in clinic. In~     this branch, the investigators will use patient control analgesic (PCA) device to investigate~     the consumption of morphine for patients undergoing hepatic surgery. Preoperative and~     postoperative (before and after surgery) blood will be sampling (15cc/time) and y liver~     tissue (10mm3) will be harvested to measure the expression of above molecules (TM, IL-20,~     HD). Pain questionnaire will also be applied to evaluate their pain control quality.~     Certainly, the morphine consumption and results from pain questionnaire will be correlated~     with the molecule amount to figure out possible relationship between morphine consumption and~     those molecules.~      Patients undergoing abdominal surgery and using morphine pain control analgesia (PCA) device~     will be involved. Pre- and Post- operative (after anesthesia and at the end of surgery) blood~     sampling (total 30 ml) plus normal liver tissue (10mm3) e will be harvested. Above~     protein(TM, IL-20, HD) amount change will be measured (ELISA for TM, IL-20 (serum) or~     flowcytometry (white cells) for TM, HD, IL-20 expression, stain or blotting for skin tissue).~     Patients will be included in this branch to check the correlation between morphine~     consumption and protein expression. Pain questionnaire (BPI, McGill) will be applied for pain~     evaluation. 2-D gel analysis will also be applied to screen further possible molecules.~      Specific aims~        1. To investigate the correlation of morphine consumption and the serum amount of IL-20, TM~          or HD~        2. To investigate the relationship between IL-20, TM, HD amount in liver tissue and~          morphine consumption~   "
125941|NCT01919021|"~     Dyspeptic symptoms, such as pain after eating, bloating and nausea all have major impact on~     quality of life and health care costs. When no structural cause is identified, patients are~     diagnosed with functional dyspepsia. This trial aims to identify objective abnormalities of~     stomach function that explain patient's symptoms and establish diagnosis. Another group are~     diabetic patients who can often develop similar symptoms, labelled as diabetic gastroparesis.~     In some cases this is associated with delayed gastric emptying but not all.~      24 patients with functional dyspepsia will be studied and 24 healthy controls (to establish~     normal ranges) and 24 diabetic patients with symptoms of functional dyspepsia.~      The utility of 3 different non-invasive investigations will be assessed. At screening the~     nutrient drink test (NDT) asks the patient to drink 40ml of milkshake (0.75kcal/ml) every~     minute and score symptoms every 5 minutes. The patient continues until they reach the maximum~     tolerated volume.~      Participants will then be randomized to undergo non-invasive imaging on two separate test~     days by magnetic resonance imaging (MRI) and gastric scintigraphy MRI will be completed with~     the patient ingesting 400ml of milkshake (identical to NDT) and 12 agar beads (no additional~     calories) of known breaking strength. The emptying of the stomach will be visualised with the~     MRI alongside symptom recording.~      Gamma scintigraphy will ingest the same meal as for the MRI scan but radioactive labelling~     will allow the rate of liquid and solid meal emptying to be visualised alongside symptom~     recording.~      Additionally, blood sugars will be recorded before nutrient drink test and at 15 and 30~     minutes following ingestion of 400ml of milkshake and 12 agar beads.~      Data will be analyzed to assess the association of objective abnormalities of gastric~     function and patient symptoms. Additionally the results of non-invasive imaging by MRI and GS~     will be compared to assess the optimal measurement of gastric function and emptying in this~     clinical scenario.~   "
125942|NCT01919008|"~     This study is to compare the pharmacokinetics of FK949E low dose tablets and FK949E high dose~     tablets in non-elderly patients with major depressive disorder. The safety of FK949E in the~     population was also evaluated.~   "
125943|NCT01918995|"~     This study is to determine the safety, tolerability, and pharmacokinetics of two or three~     repeat intravenous (IV) bolus doses of regadenoson administered 10 minutes apart in healthy~     supine subjects.~   "
125944|NCT01918982|"~     We aimed to see if aortic aneurysms could be followed-up by circulating endothelial~     progenitor cells CD34+144+CD14- and CD34+VEGF-R2+CD14- blood level.~   "
125945|NCT01918969|"~     Circulating endothelial progenitor cells CD34+144+CD14- et CD34+VEGF-R2+CD14- have been shown~     to be inversely correlated to aortic aneurysm size. However reference values have not yet~     been determined. This study is aimed to determine reference values of CD34+144+CD14- et~     CD34+VEGF-R2+CD14- in healthy men and women blood donors.~   "
125946|NCT01918956|"~     This study investigates the safety of two up-dosing regimen. The safety of PURETHAL Birch~     will be evaluated in a rush regimen (maximum dose reached in 3 injections during 3 weeks)~     compared to the conventional regimen (maximum dose reached in 6 injections during 6 weeks).~      The primary endpoint of the sudy is the comparison of the proportions of the patients who~     have successfully reached the maintenance dose between the two treatment regimes.~      A similar previous study with PURETHAL Grasses has shown that the rush up-dosing scheme is as~     safe as the conventional up-dosing regime. Therefore it is expected that up-dosing with~     PURETHAL Birch according to the rush regimen is as safe as using the conventional regimen.~   "
126072|NCT01917318|"~     The purpose of the study is to determine whether Iloperidone is effective in the treatment of~     some symptoms in patients with PTSD, particularly difficulty falling or staying asleep,~     trauma dreams and daytime irritability or outbursts.~   "
125947|NCT01918943|"~     Lumbar spinal fusion was introduced approximately 70 years ago and has evolved as a treatment~     option for symptomatic spinal instability, spinal stenosis, spondylolisthesis, and~     degenerative scoliosis.~      Many techniques evolved since then, from wiring, rods, pedicle screws, and recently~     inter-spinous fixation devices like the Aspen. Along its evolutionary trail, various methods~     for achieving circumferential fusion have arisen. Distinct from staged anterior/posterior~     fusion techniques, two methods of achieving an interbody fusion from a posterior approach~     have emerged: posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody~     fusion (TLIF). Recently, the lateral approach for interbody fusion (XLIF) has became a more~     common technique, requiring in some cases, complemental posterior fixation with pedicle~     screws, facet screws or interspinous fixation devices like the Aspen device.~      In this study, we address the clinical and radiological outcome of a novel technique using~     standard PLIF interbody fusion and insertion of the Aspen device via posterior lumbar~     approach.~   "
125948|NCT01918930|"~     The purpose of this study is to gain a better understanding about how the study drug MGA271~     works. No test drug will be given in this study. Patients with easily accessible tumors at~     the screening visit for participation in Study CP-MGA271-01 will be asked to participate in~     this substudy. Patients will undergo two excisional biopsies, punch biopsies, or core needle~     biopsies.~   "
125949|NCT01918917|"~     The purpose of this study to search efficacy of intra-articular dexmedetomidine addition to~     levobupivacaine for postoperative analgesia in arthroscopic knee surgery.~   "
125950|NCT01918904|"~     Calcinosis cutis refers to a group of disorders characterized by calcium deposition in the~     skin (1). The disorders are classified according to etiology into the following types:~     dystrophic, metastatic, iatrogenic, and idiopathic (1,2). Dystrophic calcification occurs in~     the setting of varicosities, infection, tumors, and connective tissue disorders (1). The~     connective tissue disorders most commonly associated with calcinosis cutis are systemic~     sclerosis and dermatomyositis, although it has also been reported in patients with systemic~     lupus erythematosus, undifferentiated connective tissue disorder, and mixed connective tissue~     disorder (2). The pathophysiology of calcinosis cutis is not well understood, and there is a~     broad range of severity seen, from benign localized, small nodules to large, severely~     debilitating lesions (2). Although many therapies have been investigated for treatment of~     calcinosis cutis, including calcium channel blockers, colchicine, minocycline, intravenous~     immunoglobulin, and bisphosphonates, results have been mixed at best (2). Surgical removal is~     sometimes feasible in the case of a localized lesion, however, recurrence after surgery is~     common (2).~      Recently, several authors have reported cases of dramatic resolution of dystrophic calcinosis~     cutis lesions with topical sodium thiosulfate preparations (1,3,4). Systemic sodium~     thiosulfate therapy is commonly used to treat calciphylaxis in patients with renal disorders~     with very few adverse events (1). A search of the literature to date yields no formal studies~     that aim to determine whether topical sodium thiosulfate is truly an effective therapy for~     calcinosis cutis. As a result, patients are often treated with therapies that are unproven or~     ineffective and their calcinosis cutis eventually leads to significant pain and disability.~      Research Question:~      Does treatment of dystrophic calcinosis cutis with topical sodium thiosulfate result in~     diminution of the lesion and associated pain?~      Objective:~      The objective of this pilot study is to investigate whether topical sodium thiosulfate is an~     effective therapy for calcinosis cutis. This study will also determine the feasibility of our~     protocol and provide information to help direct a future full-scale trial.~   "
125951|NCT01918891|"~     The Stroke CTI study is a 3 arm randomized, controlled trial designed to assess the~     effectiveness of a nurse practitioner (NP) only and a NP and health coach (HC) community~     transitions intervention (CTI) in reducing secondary stroke risk by helping patients lower~     their systolic blood pressure.~   "
125952|NCT01918878|"~     This is a prospective, multicenter, single arm study. The study group will be compose of~     NVAMD patients who had partial or complete failure responding to initial bevacizumab or~     ranibizumab treatment of 3-6 monthly intravitreal injections. The patients in the study~     groups will receive 5 intravitreal injections of aflibercept 2mg/0.05ml at specific visits.~     Aflibercept will be provided for total period of 24 weeks.~   "
125953|NCT01918865|"~     The purpose of this study is to evaluate the safety, tolerability, and efficacy of~     ISIS-PTP1BRx + oral antidiabetic drug/s (metformin and/or sulfonylurea) versus placebo + oral~     antidiabetic drug/s.~   "
125954|NCT01918852|"~     The study is a two-arm randomised phase III trial. Patients will be randomised to receive~     capecitabine (arm A) or S-1 (arm B). Bevacizumab may be added according to the choice of the~     investigator. Patients will be followed 3-weekly at the outpatient clinic, toxicity will be~     assessed according to study protocol guidelines. Patients will be evaluated every 3 cycles~     for response. Upon disease progression patients will be treated according to the local~     investigators~   "
125955|NCT01918839|"~     This clinical trial is intended to evaluate the efficacy and safety of injection with VINCI~     Plus as compared to Restylane-L® in correction of nasolabial fold.~   "
125956|NCT01918826|"~     The Charcot syndrome Marie Tooth is the most frequent hereditary neuromuscular diseases:~     there is no curative treatment at present, on the other hand precautionary measures can be~     taken (physiotherapy, port of splints, orthopaedic surgery and technical assistants). In the~     literature and in our recent study (evaluation of the pain in the disease of CMT - Reference~     center of the neuromuscular diseases - CHU Bow) the frequency of the pain is important~     varying from 66 to 96 % cases, affecting especially hands and lower limbs. The care of the~     pain in the Charcot syndrome Marie Tooth is not codified. The transcutaneous~     neurostimulation(TENS) is a not medicinal and not invasive therapeutics, without any brought~     back collateral effect, used at the same time in the chronic pain and acute since 1960, as~     well for the neuropathic pains that musculo-scrawny. No study was realized this day on the~     use of the TENS with analgesic aim in the CMT. We suggest studying the analgesic efficiency~     of the TENS in the Charcot syndrome Marie Tooth on the pains of lower limbs, the most~     frequent painful location in our recent works.~      The main objective will be to analyze the improvement of the pain of lower limbs, based on~     the decrease of the analogical visual scale(ladder) (EVA), at least 30 %.~      The secondary objectives will be to estimate repercussions on the functional capacities (~     ONLS), the quality of life (SF(sci-fi) 12), the satisfaction (EVA), the global~     impression(printing) of change ( PGIC), the consumption of analgesic, DN4, NPSI (Neuropathic~     Pain Symptom Inventory), Concise Questionnaire of the Pains ( QCD), HAD (Hospital Anxiety and~     Depression scale).~   "
125970|NCT01918644|"~     This phase I trial studies the side effects and best dose of stereotactic body radiation~     therapy when given together with capecitabine before surgery in treating patients with~     pancreatic cancer that can be removed by surgery. Stereotactic body radiation therapy may be~     able to send x-rays directly to the tumor and cause less damage to normal tissue. Drugs used~     in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving stereotactic~     body radiation therapy and capecitabine before surgery may make the tumor smaller and reduce~     the amount of normal tissue that needs to be removed.~   "
125957|NCT01918813|"~     This study was designed to evaluate the effect of a targeted preoperative~     Methicillin-resistant Staphylococcus aureus (MRSA) detection by polymerase chain reaction~     (PCR) on either endogenous or exogenous postoperative MRSA infections in a high risk~     population undergoing gastroenterological surgery. The primary endpoint was to investigate~     whether the potentially high incidence of MRSA infections in patients with MRSA nasal~     colonization before surgery can be prevented with a PCR-based strategy. The second endpoint~     was to investigate the impact of acquisition of MRSA colonization after surgery on the~     occurrence of MRSA infections. Investigators hypothesize that postoperative MRSA infection is~     prevented by a targeted screening strategy in preoperative MRSA carrier, and there is limited~     effect in patients with postoperative MRSA acquisition.~   "
125958|NCT01918800|"~     The purpose of this study is to compare two different educational programs for people with~     multiple sclerosis (MS), which is a common and often disabling disease of the central nervous~     system. MS causes many symptoms including difficulty walking, loss of balance or muscle~     coordination, fatigue, numbness and tingling and stiffness. The investigators want to~     determine which program is better at helping improve quality of life and MS symptoms. Both~     programs use material from the National Multiple Sclerosis Society (NMSS). Both programs~     include 6 weekly 2-hour class sessions. Up to 600 participants will be enrolled total in 4 VA~     sites, with about 150 at each site. There will be 10 study visits, all to occur within 11~     months. These include 1 baseline visit, 6 two-hour class visits, and 3 follow-up data~     collection visits. The participants in Portland will also participate in a final 12 month~     followup visit. Participants will be randomly (by chance) assigned to be part of either group~     education program. They will have a 1:1 or 50% chance of being in either program.~   "
125959|NCT01918787|"~     rTMS over dorsolateral prefrontal cortex is effective in reducing repetitive behaviors in~     adults with autistic spectrum disorder rTMS over posterior superior temporal sulcus is~     effective in improving social ability in adults with autistic spectrum disorder~   "
125960|NCT01918774|"~     In 2010, 11.5% of all Gulf War-II Veterans were unemployed; that figure rose to 15.2% in~     January 2011 and continues to grow as the number of Veterans from recent wars increases. The~     prevalence of mental illness among Veterans is also notable; estimates range from 31% to~     nearly 37% for any psychiatric disorder, and over half of these Veterans are diagnosed with~     more than one psychiatric condition. In addition, empirical evidence suggests that some~     mental disorders are more prevalent in Veterans than in the general population. Linking~     unemployment and mental illness, a recent study found that 65% of Veterans using VA~     healthcare were unemployed, and compared to employed Veterans, the unemployed were more~     likely to have depression, bipolar disorder, post traumatic stress disorder (PTSD),~     schizophrenia, or substance use disorders. Vocational dysfunction was reported most often in~     disabled Veterans with schizophrenia, PTSD, and substance use disorders. Not surprisingly,~     this study also found that unemployed Veterans had significantly lower income than employed~     persons. Similarly, a large study focusing specifically on Veterans with PTSD concluded that~     vocational dysfunction is a notable problem among this group, as they were significantly less~     likely to be employed after participating in VA work programs compared with participants~     without the disorder. Because most individuals with mental illness desire to work in regular~     competitive employment, the nationwide problem of unemployment among Veterans with mental~     illness is particularly troubling.~      The VA is addressing this need by implementing supported employment (SE), a psychiatric~     rehabilitation approach that provides individual vocational assistance to Veterans with~     mental illness. While the SE model is empirically validated and SE programs have been shown~     to achieve partial success in improving employment outcomes, a sizable proportion of~     individuals, 40% or more, remain unemployed. A further challenge is job retention; Veterans~     with mental illness who obtain jobs frequently struggle to maintain them long-term. Even in~     the context of high quality, evidence-based vocational services, most studies show only~     modest job retention of a few months, and consequently, frequent job losses and inconsistent~     vocational functioning remain a substantial and unsolved problem.~      Rationale: Cognitive behavioral therapy (CBT) effectively reduces symptoms across a range of~     psychiatric conditions; however, its benefit to functioning remains less well understood.~     Work functioning has received little empirical attention in the CBT domain. Despite research~     evidence suggesting that maladaptive thoughts about oneself and expectations about the~     ability to work interfere with work success, no CBT programs have been developed specifically~     targeting vocational themes with the goal of improving competitive work outcomes. Further, a~     recent paper outlined needed avenues of future study in the SE domain; Drake and Bond (2011)~     state that cognitive strategies may be a fruitful area to develop to help nonresponder~     consumers with mental illness who struggle with vocational dysfunction despite high quality~     vocational assistance. The goal of the current project is to address this gap and the serious~     problem of unemployment in Veterans with mental illness by pilot testing the CBT for work~     success program (CBTw) and assessing key employment outcomes before and after the~     intervention, and six months after conclusion of the intervention.~      Specific Aims:~      Aim 1: Test the preliminary efficacy of the CBTw program on key Veteran employment and~     psychosocial outcomes utilizing a pre/post design.~      Aim 2: Further assess the feasibility of the program, including recruitment, retention rates,~     and program participation rates.~      Aim 3: Gauge effect sizes in preparation for a larger randomized controlled trial examining~     the effectiveness of the CBT program in routine practice settings~   "
125961|NCT01918761|"~     To identify a dose of dacomitinib in combination with pemetrexed that is safe and tolerated~     as determined by the incidence of DLTs (dose limiting toxicities).~   "
125962|NCT01918748|"~     Rationale: Approx. 80% of acute stroke patients suffer from acute hemiparesis. Stroke~     patients have not reached their full potential when they are discharged from hospital. It is~     proven that extra training opportunities lead to further improvement. To date, new training~     possibilities, such as robotic techniques for rehabilitation, virtual reality training~     systems and tele-rehabilitation are being developed to aid in the training of stroke~     patients.~      Objective: To obtain preliminary evidence on the efficacy of an individualised, intensive~     6-week technology-assisted training regime, featuring a robotics-based self-adapting arm~     training system (I-TRAVLE) in a virtual context, focussed on improvement of arm function and~     arm skill performance in chronic stroke patients with low to moderate proximal (shoulder/arm)~     muscle strength.~      Study design: single arm prospective cohort study. Study population: 16 stroke patients in~     the chronic phase after their stroke, aged >=18, diagnosed with a central paresis of the arm,~     having low to moderate proximal (shoulder and arm) muscle strength.~      Intervention (if applicable): Haptic feedback of the I-TRAVLE robot either supports or~     challenges the patient to perform movements of the arm, thereby training motor control and~     co-ordination of the affected arm. Also strength and endurance of arm muscle use may be~     trained. The I-TRAVLE based training will last 6 weeks. Each week participants will attend~     training sessions on 3 days, during which they will train 2x 30 minutes, interspaced by at~     least half an hour to avoid (general) fatigue and overuse.~      Main study parameters/endpoints: Baseline measurements will be performed 3x prior to the~     start of the intervention, each interspaced by 1 week to assess baseline stability or any~     fluctuations in baseline values. In these chronic stroke patients spontaneous improvement is~     not expected. Also measurements will be performed at 0 weeks and at 12 weeks post training.~     Primary outcome measures: Wolf Motor Function Test, ABILHAND, and Goal Attainment Scaling.~     Secondary outcome measures are: motricity index, plate tapping task, active range of motion,~     perceived strength and fatigue.~   "
125963|NCT01918735|"~     The primary objective of this study is to evaluate the safety and tolerability of single~     ascending (increasing) and multiple doses of GWP42006 compared with placebo.~   "
125964|NCT01918722|"~     In order to investigate the time window of acute intracerebral hemorrhage(AICH) by Blood~     Activating and Stasis Dispersing therapy and to verify traditional methods if it would~     influence or enlarge the brain hematoma, test is made by random double-blind controlled.~     Patients are classified to （0-6h）and (6-72h) teams. Herbs is separated too. The period of the~     therapy lasts two weeks, and the follow up should last three months. The main indexes are~     mortality rate, disability rate and the brain hematoma situation. The review is made by the~     reference to (NIHSS),(GCS) and so on. So, the window time is determined through this test.~   "
125965|NCT01918709|"~     Primary objective : To investigate pharmacokinetics after concomitant administration of~     valsartan and rosuvastatin compared to single administration of valsartan or rosuvastatin in~     healthy male volunteers~      Secondary objective : To investigate safety profiles after the administration of valsartan or~     rosuvastatin alone and concomitant administration of valsartan and rosuvastatin in healthy~     male volunteers~   "
125966|NCT01918696|"~     The purpose of this study is to determine whether a computerized intervention designed to~     reduce anger-provoking interpretation biases will reduce suicide risk among individuals with~     elevated levels of trait anger.~   "
125967|NCT01918683|"~     This trial is designed to be the initial prospective pilot investigation of the effectiveness~     of combined SBRT and TACE as bridging therapy for HCC patients awaiting liver transplanation.~     No prospective clinical trials regarding the combination of TACE and SBRT in pre-transplant~     population have been performed. We propose the trial be conducted as a pilot clinical trial~     with the goal of enrolling 40 patients into each arm~   "
125968|NCT01918670|"~     Atrial fibrillation is the most frequent sustained arrhythmia. Catheter ablation is a~     procedure that is currently used for the treatment of symptomatic atrial fibrillation~     patients.~      We have organized a multi-centric national survey of catheter ablation of atrial fibrillation~     in order to have a feedback on the type of procedures being performed and the overall results~     (freedom of atrial fibrillation) over an average follow-up of 18 months.~   "
125969|NCT01918657|"~     The purpose of this research study is to learn about the medical effects, safety, and how the~     Walnut Oral Immunotherapy (OIT) treatment affects your body (immune system). This type of~     immunotherapy involves giving increasing doses of walnut allergen to gradually build up a~     person's tolerance to walnut and at least one other tree nut. The goal of the study is to~     determine whether participants can tolerate (eat) walnuts and at least one other tree nut in~     their diet after stopping the study therapy.~   "
130543|NCT01858636|"~     To characterize the clinical outcomes of Angio-Seal VIP with St. Jude Medical (SJM) collagen~     through the collection of device/procedure-related major vascular complications and time to~     hemostasis.~   "
125971|NCT01918631|"~     Currently, five nucleos(t)ide analogs are approved for the treatment of chronic hepatitis B,~     namely lamivudine, adefovir dipivoxil, telbivudine, entecavir (ETV) and tenofovir disoproxil~     fumarate (TDF). ETV and TDF are recommended as first-line therapy by all regional guidelines~     due to their high anti-viral potency and low risk of inducing resistance.~      ETV monotherapy for chronic HBV infection is highly effective in both HBeAg-positive and~     negative treatment-naïve patients. The cumulative probability of maintained virologic~     suppression with undetectable HBV DNA at year 1, 2 and 3 were 76.5%, 83.0% and 88.3%~     respectively.~      TDF is another potent anti-viral treatment for chronic hepatitis B. Up to 72% and 87% of~     HBeAg-positive and -negative patients achieved undetectable HBV DNA by week 144 of TDF~     monotherapy. It is also effective in patients with prior exposure to other nucleo(s)tide~     analogs. Previous studies demonstrated that TDF can be used as an effective rescue therapy in~     lamivudine or adefovir-treated patients with incomplete virologic response.~      However, the optimal treatment for patients with suboptimal response to ETV is uncertain.~     With this background, we will conduct a randomized controlled trial to evaluate the efficacy~     of TDF switch therapy in patients with incomplete virologic response to ETV treatment.~   "
125972|NCT01918618|"~     Recent experimental and clinical data suggest a benefit of levosimendan on the kidney~     function. Therefore, this retrospective, single center, matched-pairs analysis aimed to~     investigate whether administration of levosimendan was associated with improved renal~     function in cardiac surgery patients.~   "
125973|NCT01918605|"~     The purpose of this study is to evaluate the usefulness of diluted and non-diluted DuraSeal~     product as a spacer between prostate and rectum in prostate cancer low-dose brachytherapy.~   "
125974|NCT01918592|"~     Muscle invasive bladder cancer is an aggressive malignancy. Currently the investigators lack~     accurate imaging technologies in clinical staging and estimation of response to neoadjuvant~     chemotherapy as well as prognostic biomarkers.~      In the current study novel imaging modality (MRI/PET) is utilized to stage bladder cancer~     prior to transurethral resection of bladder-tumor and after neoadjuvant chemotherapy. Also~     prognostic biomarkers are studied from TUR-BT tissues, blood and urine to estimate response~     to neoadjuvant chemotherapy.~   "
125975|NCT01918579|"~     Many studies have showed that rapid point-of-care (POC) c-reactive protein (CRP) test can~     reduce inappropriate use of antibiotic at primary health care level. In Vietnam, prevalence~     of antibiotic abuse for community acute respiratory infection has been reported. This study~     will test the hypothesis that CRP POC testing for patients with non-severe acute respiratory~     illness at primary healthcare stations reduces inappropriate antibiotic use safely.~      The study will be conducted at ten district health care facilities in Hanoi, Viet Nam.~     Investigators intend to enroll 2,000 participants aged 6-65 years with non-severe acute~     respiratory infection. Patients will be randomly allocated to the control or the intervention~     arm. Participants in the control group will be treated according to routine care.~     Participants in the intervention arm will have a CRP test, the results of which will be~     available to the health care practitioner to contribute to their diagnosis and treatment~     decisions.~      All patients will be followed-up via telephone call after 14 days. The study will compare the~     proportion of patients in each arm receiving any antibiotics within 2 weeks of study~     enrollment.~   "
125976|NCT01918566|"~     Our objective is to investigate neuro-anatomical correlates of the regulation of energy~     intake by means of functional MRI. Administration of glucose with and without lactisole and~     exendin as well as fructose is followed by functional brain MRI, and findings are correlated~     with serum GLP-1 levels as an endogenous satiety signal in humans.~   "
125977|NCT01918553|"~     Age-related Macular Degeneration (AMD) is the most cause of blindness in the industrialised~     countries. There are few epidemiological studies on the incidence of this disease. Studying~     the incidence of AMD in an elderly French population and identifying the predisposing factors~     is very important to allow a major advance in the epidemiological knowledge of AMD. This~     study will contribute to the identification of the clinical, genetic and modifiable~     parameters associated at the risk of developing AMD. This could result in means prevention as~     well as in the identification of subjects as high risk of AMD~   "
125978|NCT01918540|"~     The study aims at comparing the effect of hollow or solid centralizer designs on the long~     time fixation behaviour of hip prosthesis stems that are polished, tapered and collarless. In~     a prospective, controlled and randomized study comprising two groups of 30 patients/hips~     each, the patients will be followed up by RadioStereometric Analysis (RSA) for ten years. In~     completion general health questionnaires as well as hip specific scoring instruments will be~     used to evaluate patient satisfaction and outcome.The hypothesis of the study is that the~     different centralizers will result in different migration patterns of the stems, which might~     affect the risk for late aseptic loosening.~   "
125979|NCT01918527|"~     The purpose of this study is to compare 3 cycles of neoadjuvant (preoperative) chemotherapy +~     operation with the standard treatment of locally advanced colon cancer, which is operation +~     8 cycles of (adjuvant) chemotherapy.~      Patients receiving neoadjuvant chemotherapy may not need adjuvant chemotherapy after the~     operation and, if this is the case, they will be spared of 5 cycles of chemotherapy.~   "
125980|NCT01918514|"~     Regional anesthesia is a safe, inexpensive technique, with the advantage of prolonged pain~     relief.~      In the pain clinic the investigators perform different injections as the standard treatment~     for chronic pain based on the diagnosis and indications. Local anesthetic like Bupivacaine~     with or without Steroids (Depo-medrol) is used for these injections.~      The investigators' goal is comparing pain control in different groups adding the magnesium~     sulfate 100mg to our compounds as an inexpensive, effective, and safe adjuvant to prolong the~     duration of analgesia and reduce the amount of narcotic dose.~   "
125988|NCT01918410|"~     Contact lens induced dry eyes leads to lens intolerance and discontinuation. Incidence of dry~     eye in contact lens wearer is significantly higher in Asian population compared to other~     ethnic group considering Asian has lower tear break up time. Disruptions of tear integrity in~     contact lens wearer will further exacerbate the condition. Factors for successful contact~     lens fitting derive from the biocompatibility of lens material, lens design and stability of~     tear film in front of the contact lens. This study aim to investigate the efficacy of a novel~     daily disposable contact lens with zwitterionic material that contains alginic acid which act~     as a moisturizing agent. The improved lens material may likely improve the comfort and treat~     symptomatic wearers.~   "
125981|NCT01918501|"~     Background: Multiple sclerosis (MS) is a complex and multifactorial neurological disease~     characterized by infiltration of immune cells and progressive damage to myelin and axons.~     Remyelination, the generation of new myelin in the adult nervous system, is an endogenous~     repair mechanism that restores function of axons. Neurons require considerable energy for~     their activities, including synaptic neurotransmission, and hence have significant numbers of~     mitochondria. Unlike other cell types that are able to utilize glycolysis as an alternative~     energy source, glycolysis in fully differentiated neurons is basically suppressed to maintain~     their antioxidant status. This property makes neurons highly vulnerable to ATP deficiency,~     and may be a factor in the susceptibility of neurons to cell death. Mitochondria provide~     cellular energy by converting oxygen and nutrients into adenosine triphosphate (ATP); and~     reflect local metabolic needs and via oxidative phosphorylation. Nervous tissues contain~     about 70% lipids of their dry weight, and around 40% of these lipids are polyunsaturated~     fatty acids (PUFAs).~      Goal: Understanding the relationship between blood composition, mitochondria role and~     clinical status.~      Here, we will examine expression levels of different fatty acids in the blood and monitor~     mitochondrial transmembrane potential as marker for the mitochondria general function.~      Hypothesis: Remyelination efficiency in MS is likely mediated by many factors, besides~     reducing inflammation. Remyelination may not be achieved correctly /sufficient in MS patients~     due to nutrition low content causing mitochondrial dysfunction and/or due to fatty acid~     molecules deficit unable to create a new myelin layer.~   "
125982|NCT01918488|"~     The purpose of the study is to determine whether a diuretic drug called amiloride is capable~     of increasing renal salt excretion and thereby decrease blood pressure in diabetic patients~     with kidney disease. Our hypothesis states that amiloride is capable of reducing blood~     pressure in these patients and thus decrease the cardiovascular risk associated with diabetic~     kidney disease.~   "
125983|NCT01918475|"~     Carbetocin is a synthetic analogue of the hormone Oxytocin and is routinely used in obstetric~     anesthesiology to control uterine bleeding after cesarean section. As an incidental finding,~     women who received carbetocin had less pain after cesarean section than women who had~     received Oxytocin. Carbetocin may therefore have an analgesic effect.~      The present study examines this analgesic effect using different sensory tests, e.g.~     pressure, heat, cold and electrical pain before and after administration of carbetocin in~     healthy male volunteers. Any changes in these sensory tests might be indicative of an~     analgesic property of carbetocin.~   "
125984|NCT01918462|"~     The purpose of this study is to investigate the production, effects and interactions of the~     hepato-protective cytokine interleukine (IL)-22 in patients with alcoholic hepatitis.~   "
125985|NCT01918449|"~     The objective of the study is to compare the results of a coordinated and interactive program~     for the treatment, monitoring and control of patients with a moderate-severe diagnosis of~     Obstructive Sleep Apnea (OSA) and treated with positive continuous pressure (CPAP), with the~     currently established situation.~      Methodology: Equivalence randomized comparative study . It will include patients with~     diagnosis of moderate-severe OSA (apnea-hypopnea Index >=15) that should start treatment with~     (CPAP). Participating center is Hospital Santa María-Arnau de Vilanova in Lleida~     (Spain).These patients will be randomized to two monitoring groups (1: monitoring in the~     Sleep disorders unit, 2: monitoring in primary care consultations) once the OSAS diagnosis~     has been made and it was indicated that treatment with CPAP. Patients Will be carried out in~     both groups the same follow-up visits in two study arms: basal, 1 month, 3 months and 6~     months. Primary outcomes: number of hours of use per day (according to the accountant of the~     CPAP), so that use >= 4h/day is defined as good adherence to the treatment. Secondary~     outcomes: daytime sleepiness, patient satisfaction, Adverse events related to CPAP treatment.~     It will be collected demographic ,clinics and anthropometric variables. At the end of~     follow-up primary and secondary outcomes will be compared between two groups.~   "
125986|NCT01918436|"~     Background:~      TEAMS (Training Executive Attention and Motor Skills) is a non-pharmacological,~     neurocognitive intervention program targeted preschool children with ADHD developed by~     Professor Jeffrey Halperin, and his team from New York University. The uniqueness of this~     program lies in the concept, based on stimulating neurocognitive growth through focused~     physical activity and play (Halperin et al.; 2011, 2012, in press).~      Teams hypotheses:~      TEAMS is based on the notions that:~        1. The behavioural manifestations of ADHD are the result of deficient neural networks that~          affect a wide array of neurocognitive and behavioural processes which are not~          necessarily identical in all children with the disorder.~        2. Neurodevelopment is sensitive to and can be positively affected by appropriate~          environmental influences.~        3. Effective environmental stimulation will be best achieved within a social context.~        4. The engagement of the child in the core activities of the treatment must be~          intrinsically rewarding (i.e., fun) in order to facilitate compliance of the~          intervention.~      The initial research by Halperin et al. (2012)indicated significant improvement in ADHD~     severity from pre- to post-treatment, which also persisted 3 months later.~      Objective: The aim of this study is, through a randomized controlled trial (RCT), to validate~     the TEAMS treatment program in a clinical setting in Denmark.~      Method: Pre-school children age 3-6, from Region Zealand in Denmark, diagnosed with ADHD as~     primary diagnosis are offered participation in the RCT study of the TEAMS program. The~     control groups receive the standard treatment program, outlined by the clinical guidelines of~     Region Zealand. The intervention groups participate in eight weekly group sessions consisting~     of separate parent- and children's groups.~      In the child group the children are introduced to games that are designed to enhance~     inhibitory control, working memory, attention, visuospatial abilities, planning, and motor~     skills. The parent group consists of psychoeducation and instructions in how to encourage~     playing these games with their children and how to support the child's development.~   "
125987|NCT01918423|"~     Children born to obese women are at risk of increased adiposity and later adverse metabolic~     outcomes. We have conducted a follow-up study on an existing clinical trial, called the LiP~     study (Lifestyle in Pregnancy), registration number NCT00530439,in which 360 obese pregnant~     women were randomized to either lifestyle intervention or routine obstetric care. This~     present study follows the children until 3 years of age. We have the hypothesis, that the~     intervention during pregnancy results in a lower degree of adiposity and metabolic risk~     factors in the offspring. Clinical examination is taking place at age 2.5-3 years including~     anthropometric measurements, Dual energy x-ray (DXA) scans and blood samples measuring~     metabolic markers.In addition, we have included an extra control group of children born to~     normal weight women, who were not part of a lifestyle intervention program during pregnancy.~     We have the hypothesis that the children of the normal weight women have a better metabolic~     profile than the children born to the obese women.~   "
126073|NCT01917305|"~     The concept of platform-switching has been introduced to implant dentistry based on clinical~     observations of reduced periimplant crestal bone loss. However, published available data are~     controversial and most studies are limited to 12 months. The aim of the present RCT was to~     test the hypothesis that platform-switching has a positive impact on crestal bone level~     changes after 3 years.~   "
125990|NCT01918384|"~     Duchenne Muscular Dystrophy (DMD) is inherited neuromuscular disorders due to mutation in the~     gene that encodes critical muscle protein called dystrophin. Currently, there is no effective~     treatment option for the disease. A pharmacological approach by promoting mRNA translation~     regardless of the presence of premature stop codons by nonsense mutation, called the~     readthrough strategy, has been developing recently for DMD with nonsense mutation. NPC-14 is~     a candidate compound for the readthrough strategy, since effective readthrough activities~     were demonstrated in nonclinical studies. This study is a phase II study designed to assess~     safety, tolerability, and efficacy of NPC-14 in ambulant DMD patients with nonsense mutation~     that were confirmed by whole genome analysis. These goals will be accomplished by monitoring~     adverse events by physical examination, cardiac, pulmonary, auditory, balance, and laboratory~     tests as safety endpoints, and dystrophin expression in muscle biopsy as primary efficacy~     endpoint, muscle function (NSAA, timed test, muscle strength (QMT, MMT) , dairy activities by~     lifecorder), and biomarkers as secondary efficacy endpoints. The study is a randomized,~     double blind, placebo-controlled study in 21 DMD patients. After screening, eligible patients~     are allocated dynamically to weekly NPC-14 or a placebo (saline) in a 2:1 ratio and will~     receive study drugs for 36 weeks.~   "
125991|NCT01918371|"~     This retrospective data review study will evaluate anti-VEGF injections for retinal vein~     occlusion (RVO) or diabetic macular edema (DME).~   "
125992|NCT01918358|"~     To compare the safety and pharmacokinetics between ROVATITAN tab. 160/20 mg (ROVATITAN tab~     160/20mg-1, ROVATITAN tab. 160/20mg-2) and coadministration of Diovan® (Valsartan) 160 mg and~     Crestor® (Rosuvastatin) 20 mg in healthy male volunteers~   "
125993|NCT01918345|"~     Mothers with previous gestational diabetes mellitus (GDM) represent a population at higher~     risk of future Type 2 diabetes mellitus (T2DM), which is preventable through lifestyle~     modification. Yet, no formal prevention programs exist for this population. The postpartum~     period is a particularly vulnerable period for weight gain and unhealthy lifestyle in new~     mothers due to their competing demands of childcare and breastfeeding. This important time~     period may thus represent a 'window of opportunity' for women with previous GDM, whereby~     interventions to improve their lifestyle can be offered. Eligible women will be recruited~     during pregnancy from four hospitals and invited to participate in a home-based lifestyle~     intervention program starting from three to six months postpartum. This pilot study will~     investigate the feasibility and effectiveness of a physical activity and diet intervention.~     It will also explore the relationship between behaviour change and metabolic markers of T2DM~     in this high-risk population. Investigators hypothesize that the ADAPT-M program will be~     feasible and will be associated with an improvement in metabolic T2DM markers, as well as a~     high rate of satisfaction, adherence, and effectiveness.~   "
125994|NCT01918332|"~     This study aims to evaluate the efficacy and safety of the coadministration of valsartan~     (Diovan®) 160mg and rosuvastatin (Crestor®) 20mg in comparison to each component administered~     alone in patients with hypertension and hyperlipidemia.~   "
125995|NCT01918319|"~     Children born to obese women are at risk of increased adiposity and later adverse metabolic~     outcomes. We have conducted a follow-up study on an existing clinical trial, called the LiP~     study (Lifestyle in Pregnancy), registration number NCT00530439,in which 360 obese pregnant~     women were randomized to either lifestyle intervention or routine obstetric care. This~     present study follows the children until 3 years of age. We have the hypothesis, that the~     intervention during pregnancy results in a lower degree of adiposity and metabolic risk~     factors in the offspring. Clinical examination is taking place at age 2.5-3 years including~     anthropometric measurements, Dual energy x-ray (DXA) scans and blood samples measuring~     metabolic markers.~   "
125996|NCT01918306|"~     This phase I/II trial study evaluates the tolerability and best tolerated dose of the PI3K~     inhibitor GDC-0941 when given with the chemotherapy cisplatin. This study will also examine~     how well the combination of GDC-0941 and cisplatin work in treating patients with androgen~     receptor negative triple negative metastatic breast cancer. Patients will be randomized to~     receive cisplatin alone or cisplatin with GDC-0941 in the phase II portion. Those receiving~     cisplatin alone can receive GDC-0941 upon progression of their disease. Cisplatin is a~     chemotherapy which has been shown to be effective in treating triple negative breast cancer.~     Preclinical studies show that adding a PI3K inhibitor such as GDC-0941 to cisplatin may be a~     more effective treatment for breast cancer.~   "
125997|NCT01918293|"~     Bronchial asthma is an chronic airway disease with bronchial hypersensitivity due to~     inflammation and bronchial muscle contraction. It can cause recurrent dyspnea, cough,~     wheezing and severe life-threatening attack and lower quality of life. In addition, it make~     large amount of socioeconomic loss as about 3.7 billion US dollars.~   "
125998|NCT01918280|"~     Klinefelter Syndrome (KS) is the most common sex chromosomal abnormalities (1/600 newborn~     males), and is characterized by a hypergonadism hypogonadism. Until few years ago, mostly~     non-mosaic KS was considered as a model of a complete male infertility although few KS (4-8%)~     have an oligospermia. Recent studies in adult with non-mosaic KS reported the possibility of~     sperm retrieval by testicular biopsy (TESE) in around 50% cases and more than some~     pregnancies have been obtained after TESE with Intracytoplasmic Sperm Injection (ICSI). Since~     1997, more than one hundred births are described.~      As some studies shown a decrease of successful sperm retrieval with the increasing of age, we~     plan to compare the potential of sperm retrieval between two groups adult (23-55 years) and~     young after the onset of puberty (15-22 years). The study will be performed by searching~     spermatozoa on two seminal analyses spaced out 3 months followed by a testicular biopsy if~     the azoospermia is confirmed on semen analyses.~   "
125999|NCT01918267|"~     This non-interventional, observational, open-label multi-center follow-up study of patients~     from the U-Act-Early trial (ML22497) will evaluate the long-term efficacy and safety of~     starting tight control treatment with RoActemra/Actemra (tocilizumab) and/or methotrexate in~     patients early in the disease followed by treatment according to standard of care in routine~     clinical practice in a three year follow-up, independently of what treatment the patient will~     be receiving.~   "
126074|NCT01917292|"~     The purpose of this study is to determine the effect of periodontal intervention on vascular~     dysfunction among Chinese prehypertensive adults with moderate to severe periodontal disease.~   "
130544|NCT01858623|"~     This study was conducted to investigate any potential reaction between losartan and~     hydrochlorothiazide.~   "
126000|NCT01918254|"~     This multicenter, open-label dose-escalation study with an extension phase will evaluate the~     safety and pharmacokinetics of lumretuzumab in combination with pertuzumab and paclitaxel in~     participants with metastatic breast cancer expressing HER3 and HER2 protein. Cohorts of~     participants will receive escalating doses of lumretuzumab intravenously (IV) every three~     weeks (Q3W) in combination with pertuzumab 840 milligrams (mg) IV initial dose followed by~     420 mg IV Q3W and paclitaxel 80 milligrams per square meter (mg/m^2) IV weekly. After~     completion of dose-limiting toxicity period (21 days), the study will be conducted in two~     extension phase cohorts: Cohort 1 and Cohort 2. Enrollment in Extension Phase Cohort 2 will~     occur only upon completion of Extension Phase Cohort 1. Anticipated time on study treatment~     is until disease progression or unacceptable toxicity occurs.~   "
126001|NCT01918241|"~     This study will assess the Efficacy and Safety of different doses of PEG-rhG-CSF and a~     single-dose of G-CSF in Preventing Chemotherapy-induced Neutropenia.~   "
126002|NCT01918228|"~     RCT study of the effect of an educational-based intervention on low back pain-related~     outcomes concerning beliefs and behaviour.~   "
126003|NCT01918215|"~     Contemporary heart failure (HF) guidelines recommend insertion of a primary prevention~     implantable defibrillator (ICD) in patients with left ventricular ejection fraction less than~     35% (LVEF < 35%) on maximally tolerated medical therapy. Nevertheless, there are a~     substantial number of HF patients who have LVEF>35% and hence do not qualify for ICD, who~     succumb to sudden cardiac death (SCD). At present our tools to reliably risk stratify these~     patients with mild-moderate systolic dysfunction (LVEF 36-50%) are poor. It is likely that~     these patients have ventricular scar and/or replacement fibrosis as a substrate for their~     malignant arrhythmia. Cardiovascular magnetic resonance imaging (CMR) can reliably identify~     and quantify both ventricular scar (seen in Ischaemic cardiomyopathy, ICM) and replacement~     myocardial fibrosis (seen in Non-Ischemic Cardiomyopathy, NICM).~      Methods/Design: A multi-centre randomised controlled trial in which 428 patients with~     mild-moderate left-ventricular systolic dysfunction (either ICM or NICM) and ventricular~     scar/fibrosis on cardiovascular magnetic resonance are randomized to either ICD or~     implantable loop recorder (ILR) insertion and are followed up until the last patient~     recruited has been in the study for 3 years.~      Potentially eligible patients will have a screening CMR and will be enrolled into the device~     arm of study based on the presence of any ventricular scar/fibrosis (CMR +). Patients who do~     not have ventricular scar/fibrosis will be followed up in an observational registry, and will~     not be randomised.~      In both the device and registry arms, we aim to enrol 700 patients in Australia and 355 in~     Europe.~      The primary hypothesis is that among patients with mild-moderate left ventricular systolic~     dysfunction, a routine CMR guided management strategy of ICD insertion is superior to a~     conservative strategy of standard care.~   "
126004|NCT01918202|"~     This Phase 1 study will evaluate PDE10 enzyme occupancy using Positron Emission Tomography~     after a single dose of PF-02545920 in Healthy male volunteers.~   "
126005|NCT01918189|"~     The purpose of the proposed project is to develop and test how well an internet-based~     behavioral pain self-management program, the Pain EASE program, can be used for treating low~     back pain in Veterans. Veterans' experiences with usability and satisfaction with the Pain~     EASE program will also be examined. Behavioral interventions such as exercise and cognitive~     behavior therapy are known to be effective for low back pain but are often not readily~     available or easily accessed. Veterans will be able to access the Pain EASE program via their~     computer with an internet connection, which will increase access to this type of treatment.~     Study participants will receive 10 weeks of access to the Pain EASE program, which will teach~     them pain coping skills to manage their low back pain. The primary outcome is pain-related~     functional interference.~   "
126006|NCT01918176|"~     Fixed sequence, 2-period crossover study to compare the pharmacokinetic profiles of~     Palbociclib in absence and presence of prior administration of proton pump inhibitor~     Rabeprazole. The increased gastric pH achieved by the treatment with multiple doses of~     Rabeprazole might affect the absorption process of Palbociclib.~   "
126007|NCT01918163|"~     Some animal studies revealed that the pomegranate juice may improve sperm quality in terms of~     concentration, motility and morphology, as well as in fertilization rate.~      Minor data is available regarding the influence on male sperm.~   "
126008|NCT01918150|"~     The purpose of this study is to compare the effectiveness and safety, at 24 months, of the~     TITAN2 stent to any bare-metal stent (BMS) in Cobalt-Chromium in a population presenting an~     indication for these stents among 40% of which present an acute coronary syndrome (ACS).~   "
126009|NCT01918137|"~     The deep fried chocolate bar is a snack that the international community strongly associates~     with Scotland. It has previously been cited as being a symbol of all that is wrong with the~     high-fat, high-sugar Scottish diet. Despite the snack's reputation, no medical research has~     been performed to examine the effects of consuming a deep fried chocolate bar on the human~     body.~      In contrast to the deep fried chocolate bar, porridge has been shown to reduce the risk of~     cardiovascular disease, but its effect on cerebral blood flow has yet to be directly~     assessed.~      This study will focus on the potential (patho)physiological cerebrovascular effects of the~     deep fried chocolate bar and porridge. The research question to be addressed in this study is~     Does eating a deep fried chocolate bar or bowl of porridge induce changes in cerebral blood~     flow and cereborvascular reactivity in healthy adults?~      To assess the acute effects on eating either food on blood flow through the largest artery in~     the brain, the investigators will give healthy volunteers one regular-sized deep-fried~     chocolate bar or a bowl of porridge. Blood flow through the largest artery in the brain will~     be assessed using simple ultrasounds tests. The investigators aim to recruit 24 volunterrs~     who will visit twice, consuming a different food on each visit.~   "
126010|NCT01918124|"~     This phase II clinical trial was designed to assess the feasibility, safety, toxicity,~     recurrence and survival pattern when TP or CAP chemotherapy was combined with adjuvant~     radiation for patients with high-risk endometrial cancer.~   "
126075|NCT01917279|"~     It is a phase III trial to explore the efficacy and safety of metronomic chemotherapy with~     Capecitabine versus intermittent Capecitabine as maintenance therapy following first-line~     Capecitabine plus Docetaxel chemotherapy in treatment of HER2-negative metastatic breast~     cancer(mBC).~   "
126076|NCT01917266|"~     The purpose of this study is to evaluate Cardiac Resynchronization Therapy(CRT) response in~     subjects with concordant versus discordant left ventricular (LV) lead position as compared to~     the site of latest mechanical activation.~   "
126077|NCT01917253|"~     The Long and Short is a prospective, randomized, controlled, open label trial to test the~     complications of different device for peripheral vein cannulation, standard length (about 5~     cm in length) and long catheter (about 12 cm in length), inserted with Seldinger technique.~   "
130545|NCT01858610|"~     This study was conducted to investigate any potential reaction between irbesartan and~     hydrochlorothiazide.~   "
126011|NCT01918111|"~     1. (RENEWAL-EXERCISE trial) The investigators hypothesize that the increased sympathetic~          nervous system activation that is associated with resistant hypertension is a major~          contributor in the pathogenesis of exercise diastolic dysfunction and that modulation of~          the sympathetic nervous system activity with radiofrequency ablation of the renal artery~          sympathetic nerve fibers delivered via a treatment catheter, will have a significant~          effect on the diastolic function that is beyond BP-lowering effect.~        2. (RENEWAL-REGRESSION trial) The major cause of mortality and morbidity in hypertension is~          atherosclerotic cardiovascular disease. the significant decrease in the sympathetic~          nervous system activation after renal sympathetic denervation will contribute to~          regression over and beyond it's effect of blood pressure reduction.~        3. (RENEWAL-PREDICT trial) No data exists regarding the tests or methods predicting the~          successful renal denervation causing the effective reduction of BP. For these, the~          investigators sought to perform the new tests such as adenosine infusion test during~          procedure and skin sympathetic activity measurement before and immediate post-procedure~          (detailed explanation provided in section of Methods) and then evaluate the association~          between these tests and reduction of BP following procedures.~   "
126012|NCT01918098|"~     To determine the improvement in symptoms of constipation in subjects receiving treatment with~     oxycodone/naloxone prolonged release tablets (OXN) compared to oxycodone prolonged release~     tablets (OXY) based on the Bowel Function Index (BFI)~   "
126013|NCT01918085|"~     The aim of the study is to investigate the correlation in peel force when peeling off a~     standard hydrocolloid adhesive strip and standard strata adhesive strip from peristomal skin~     compared to pre-stripped healthy abdominal skin in colostomists.~   "
126014|NCT01918072|"~     VA community-based outpatient clinics (CBOCs) typically serve only a small number of women~     Veterans, and generally do not have the women's health care resources that are available in~     larger settings. Women Veterans using these sites for primary care must sometimes travel to~     other sites to receive women's health care. That can create travel burdens, reduce continuity~     of care, and negatively affect patient outcomes. To address this, VA is implementing a~     clinical operations innovation that supports women's primary care providers with a~     technology-based intervention that combines interactive communication with women's health~     specialists and ongoing education. This research study is evaluating the implementation and~     effects of this women's healthcare delivery innovation. Findings from this research will~     inform VA women's health clinical practice and education, and will advance science in~     delivering technology-supported non-face-to-face care that is applicable to other clinical~     conditions and patient populations.~   "
126015|NCT01918059|"~     This project is a randomized, controlled trial investigating wound cosmetic appearance after~     repair of traumatic lid lacerations with three different approaches to skin closure:~     absorbable sutures, non-absorbable sutures, and tissue adhesive. Photographs will be taken at~     two intervals after repair and later blindly assessed using standard cosmetic assessment~     scales. The investigators hypothesize that cosmetic wound outcome will be equivalent in~     across all three treatment arms.~   "
126016|NCT01918046|"~     This is a single-center, prospective sample collection study. Samples will be used to~     establish the performance characteristics of myo-inositol oxygenase (MIOX) as an aid in the~     early diagnosis of acute renal injury (AKI) following cardiac surgery.~   "
126017|NCT01918033|"~     This is a study to evaluate the efficacy and safety of desloratadine (MK-4117) in Japanese~     participants with perennial allergic rhinitis. The primary hypothesis is that desloratadine~     is superior to placebo after 2 weeks of treatment with regard to change from baseline in~     Total Nasal Symptom Score among Japanese participants with perennial allergic rhinitis.~   "
126018|NCT01918020|"~     Supplemental Nutrition Assistance Program - Education (SNAP-Ed) is a national initiative with~     the goal of improving the health and wellbeing of low income families. University of~     Minnesota Extension every year offers nearly 4000 educational events, serving approximately~     70,000 Minnesotans through the program. Extension is conducting an impact study to determine~     program effectiveness and assess sustained changes of participants and their families that~     can be directly attributed to programming on a larger and methodically sound scale.~   "
126019|NCT01918007|"~     Obstructive sleep-disordered breathing (SDB) in childhood is a disorder of breathing during~     sleep characterized by intermittent upper airway obstruction. Snoring, labored breathing and~     apneas reported by the parents are the most frequent symptoms.Obstructive SDB can result from~     many different abnormalities including large adenoids and tonsils or obesity.~      Intermittent upper airway obstruction during sleep is accompanied by low oxygen or high~     carbon dioxide in the blood and arousals from sleep. If obstructive SDB is not treated,~     complications may develop such as: i) enuresis; ii) delay in somatic growth rate; iii)~     central nervous system morbidity (e.g. hyperactivity and learning difficulties); and iv)~     elevated blood pressure.~      Overnight polysomnography (PSG) is considered the gold-standard method for defining severity~     of obstructive SDB and subgroups of children with snoring who should be treated. However, PSG~     is a labor-intensive, time-consuming and expensive diagnostic method, which is not available~     in many community settings. Thus, there is an urgent need for developing easy-to-use and~     low-cost diagnostic methods which can be used to determine severity of obstructive SDB and~     define subgroups of children with snoring and large adenoids and tonsils who will benefit~     from adenotonsillectomy (AT).~      Pulse oximetry is a widely available, non-invasive method which allows continuous monitoring~     of oxygen transport by hemoglobin. Episodes of upper airway obstruction are frequently~     accompanied by reductions in the hemoglobin oxygen transport (oxygen desaturation of~     hemoglobin).The hypothesis of this research project is that subgroups of children with~     snoring and adenotonsillar hypertrophy and certain abnormalities in oxygenation detected by~     nocturnal pulse oximetry will benefit from AT in a community setting.~   "
126078|NCT01917240|"~     To evaluate the impact of two FDA approved culture media on potential of human embryos~     resulting from IVF (sequential & monophasic media). Half of each patient's embryos will be~     randomly assigned to grow in monophasic media & the other half in sequential media. All~     embryos will undergo Comprehensive Chromosome Screening (CCS) & the best euploid embryo from~     each group will be transferred resulting in a double embryo transfer (DET). If there are only~     euploid embryos from one group, patient will have single embryo transfer (SET)(fresh or~     frozen).~   "
126020|NCT01917994|"~     Retention in care and virologic suppression are the key final steps of the HIV treatment~     cascade. Poor or intermittent retention has been associated with later initiation of~     antiretroviral therapy, virologic failure, and death. Regular HIV care has also been~     associated with a decrease in HIV transmission risk behavior. Despite the proven health and~     prevention benefits of consistent HIV care, only 40-50% of those infected with HIV in the~     United States are estimated to meet current retention in care standards and even fewer - only~     about 25% - are estimated to be virologically suppressed.~      The Behavioral Model for Vulnerable Populations provides a useful framework for understanding~     broad areas that may impact adherence to care and treatment. Individual-level domains include~     vulnerable (e.g., depression, stigma), enabling (e.g., social support, positive affect), and~     need (e.g., co-morbidities) factors, and structural domains include, for example, features or~     the clinic and the provider-patient relationship.~      Short message service (SMS) technology represents a new and exciting tool to help retain~     HIV-infected patients in care and treatment. SMS interventions have been deployed~     successfully in support of antiretroviral adherence and virologic suppression in sub-Saharan~     Africa, where two randomized trials have showed clear benefits. A pilot study conducted in~     our clinic suggests that use of SMS messages to promote adherence to care and treatment in~     the urban HIV-infected poor is both feasible and acceptable.~      The investigators believe that combining SMS technology with content-specific messages~     designed to impact factors highlighted in the Behavioral Model for Vulnerable Populations can~     improve retention in care and virologic suppression for an urban public hospital population~     living with HIV, thus the investigators propose the following specific aims.~      Specific Aim 1: Determine whether a behavioral theory-based SMS intervention improves~     virologic suppression [primary outcome] and retention in care [secondary outcome] for a~     vulnerable urban HIV-infected population through a randomized trial of this technology~     compared to SMS appointment reminders alone. Retention in care will also be analyzed as a~     mediator of virologic suppression. Exploratory outcomes include time to virologic~     suppression, sustained virologic suppression, emergency department utilization and~     antiretroviral adherence, as well as levels of depression, positive affect, social support~     and empowerment.~      Specific Aim 2: Examine patient experiences with the SMS intervention, focusing specifically~     on: 1) satisfaction with this technology; 2) identifying barriers to and facilitators of~     patient use of this technology, and; 3) the preferred frequency and content of intervention~     messages.~      Specific Aim 3: Conduct cost and cost-effectiveness analyses of the SMS intervention.~   "
126021|NCT01917981|"~     This study aims to determine the sensitivity and specificity of a Personal Heart Rhythm~     Monitor in the detection of prolonged paroxysmal atrial fibrillation (defined as lasting more~     than 12 hours) against pre-existing implantable devices, seen to be the 'gold-standard' for~     arrhythmia detection.~   "
126022|NCT01917968|"~     The purpose of this study is to compare transvaginal mesh repair to traditional native tissue~     repair in women surgically treated for anterior and/or apical pelvic organ prolapse.~   "
126023|NCT01917955|"~     The purpose of this prospective single-center trial is to compare the safety and diagnostic~     value of contrast medium-enhanced cardiac magnetic resonance imaging and transesophageal~     echocardiography in patients with acute ischemic stroke.~   "
126024|NCT01917942|"~     This is a two arm randomised phase III trial which will evaluate prospectively the benefits~     of humidification in patients receiving radiotherapy / chemoradiation for head and neck~     cancer. The intent of humidification is to moisturise the mucosa. The rationale for the use~     of humidification with radiotherapy can be considered an extension of the general principle~     of moist wound care in wound management.~   "
126025|NCT01917929|"~     This study is a prospective, open-label, post-market, non-randomized, multi-center clinical~     evaluation of the Secur-Fit Advanced Hip Stem for primary total hip arthroplasty with a~     cementless application in a consecutive series of patients who meet the eligibility criteria.~     The success rate of the Secur-Fit Advanced femoral stem, defined as absence of stem revision~     for aseptic loosening or femoral fracture, is expected to be no worse than 99% at 5 years~     postoperative with a non-inferiority margin of 2.5%.~   "
126026|NCT01917916|"~     Safety, tolerability, pharmacokinetics and pharmacodynamics of BI 655064 after single rising~     doses in healthy Asian male volunteers.~   "
126027|NCT01917903|"~     This study will evaluate gait when individuals with Parkinson's disease (PD) are walking~     while talking to see how walking changes when challenged to perform a functional cognitive~     task simultaneously. By looking at walking alone and walking with varying cognitive loads the~     investigators will be able to determine motor and cognitive factors vulnerable to~     interference in PD. Each is important to understand so that training can address components~     of walking that become impaired when someone is distracted by a common cognitive task and so~     that the intensity of treatment matches the level of task difficulty. Using this initial~     data, the investigators will establish a protocol to improve walking taking into account the~     unique features of PD, including bradykinesia, freezing of gait, stiffness, and problems with~     memory and attention. The investigators will evaluate the potential for this treatment to~     improve walking and improve or maintain cognitive abilities necessary to multitask.~   "
126028|NCT01917890|"~     Prostate cancer is the second most incident cancer among male population worldwide. Radiation~     therapy by itself or along with surgery and chemotherapy are the main treatments for prostate~     cancer however prostate cancer cells are only modestly responsive or even unresponsive to the~     cytotoxic effects of radiotherapy. Recently some in vitro and in vivo studies showed~     radiosensitizing and radioprotective effects for curcumin. No clinical trial has been done in~     this area and it is not yet known whether radiation therapy is more effective with or without~     curcumin supplements in treating patients with prostate cancer.~   "
126029|NCT01917877|"~     Due to the radiosensitivity of the lung, radiation-induced and chemotherapy-induced~     pneumonitis and pulmonary fibrosis are frequent happened following cancer therapy. It not~     only compromise cancer treatment, but also influence patient's life qualities and even death.~     there are no specific treatment modalities for this treatment-induced complication.~     Bevasizumab (Avastin), a VEGF inhibitor, can attenuate serum high expression VEGF and~     pulmonary permeability, maybe effective in the control acute pulmonary fibrosis. Patients~     will be randomized to receive Bevasizumab (7mg/kg iv) on day one and 21, followed by~     Dexamethasone （10mg iv d 1-10, then 5mg iv d11-15, 2.5mg iv d16-20) or Dexamethasone alone.~     The thoracic CT, plasma TNF-a, IL-6, VEGF and C-reactive protein are accessed on before~     treatment, 24 hours after Bevasizumab, 7 days, 4 and 8 weeks. the target sample size is 30~     cases.~   "
126030|NCT01917864|"~     The purpose of this study is to evaluate the utility of a specialized iPad application~     designed to treat difficulties with intonation (e.g., melody in voice) in children with~     autism spectrum disorders (ASD) and other communication disorders.~   "
126031|NCT01917851|"~     The purpose of the study is to define the precision, accuracy and variability of the NBM-200~     system in non invasive blood Hemoglobin (Hb) measurements relative to the laboratory blood~     analyzer by comparing two consecutive Hb values obtained by the NBM system to venous values.~   "
126125|NCT01916629|"~     Photocil is a topical drug (cream) that selectively delivers Narrow Band - Ultraviolet B~     (NB-UVB) therapy when exposed to sunlight. Photocil is intended to help protect users from~     non-therapeutic Ultraviolet B (UVB) radiation while selectively passing wavelengths of light~     in the NB-UVB range with peak transmission of 308nm. The aim of the study is to assess the~     safety and efficacy of Photocil in the treatment of psoriasis~   "
126032|NCT01917838|"~     The goal of this two-year R34 treatment development grant is to develop a mobile health~     (mHealth) application that will both advance theory in and clinical practice of homework (HW)~     implementation.~      HW can be described as between-session exercises where the client practices specific skills~     learned within-session in order to promote skill acquisition, which ultimately leads to~     improved acute- as well as longer-term therapeutic benefits on targeted outcomes,~     generalization of treatment effects and maintenance of treatment gains. Despite data~     demonstrating that HW is critical to achieving maximal benefits from evidence-based~     treatments, very little theory-driven approaches have been conducted focusing on improving~     the HW process. Through utilizing self-determination theory as a guiding framework and~     integrating principles from the field of gamification and goal-setting, the aim is to~     develop a two-component mHealth HW application (My MFG).~      The first component focuses on delivering HW via a highly engaging, multiplayer, interactive,~     cooperative, and skill-building game platform aimed at improving the Design and Do~     process of HW. The second component focuses on targeting factors putatively related to poor~     HW implementation within the Do process.~      The process of the development of My MFG will be guided by the clinic and community~     development model and iterative software development process to maximize the feasibility and~     sustainability of My MFG within practice settings often characterized by limited resources.~     Findings from this study have broad implications for evidence-based treatments for youth and~     adult mental health disorders that emphasize HW as the link between treatment and~     improvements in targeted outcomes.~   "
126033|NCT01917825|"~     The primary objectives of this clinical trial are to investigate the pharmacokinetics and~     safety of MDT-15 pellets in escalating sequential doses administered to different cohorts.~     Preliminary efficacy data will also be collected for assessment.~   "
126034|NCT01917812|"~     Despite their importance, health-related behaviors are hard to change. Among behaviors,~     physical activity is associated with protection from multiple diseases. People who are~     physically active have lower risk for heart disease, stroke, type 2 diabetes, depression, and~     some cancers with associated dose-dependent reductions in cardiovascular and all-cause~     mortality. However, most US adults do not meet CDC physical activity guidelines. Sedentary~     work behavior in industrialized nations is likely a contributor to this problem.~      Current low-technology strategies for encouraging lifestyle change are disappointingly~     ineffective and are highly resource intensive. Systematic reviews of the literature show~     mixed evidence for using activity trackers (i.e., pedometers) and a limited body of evidence~     for text messaging in preventive health care. However, prior studies have not integrated~     digital activity tracking with mobile phone text messaging feedback.~      Given 91% of adults in the United States now use a mobile phone, and 56% a smartphone, this~     represents a potentially widely applicable avenue for therapeutic intervention. There is~     growing interest in leveraging mobile health (mHealth) technologies to improve health~     behaviors in the general population. The investigators propose to conduct a blinded,~     randomized mHealth trial of digital activity tracking and smart texting to promote physical~     activity.~   "
126035|NCT01917799|"~     Efficacy of low dose aspirin (LDA) versus LDA plus low-molecular-weight-heparin (LMWH) in~     patients with a history of recurrent miscarriages.~   "
126036|NCT01917786|"~     Various medications used in anesthesia have been implicated in the prolongation of QT~     interval. Recently, there has been an increase in the use of dexmedetomidine in patients~     presenting for surgeries given its beneficial sedative, anxiolytic, and analgesic properties.~     It has several desirable properties including minimal respiratory side effects as well as the~     ability to decrease intraoperative and postoperative analgesic requirements. In many of the~     patients who present for routine surgical procedures, dexmedetomidine is a common component~     of their anesthetic care. This is a study to assess the effects of dexmedetomidine on the QT~     interval in children presenting for surgery.~   "
126037|NCT01917773|"~     The research study is designed to test how a medication called octreotide affects the~     motility (contraction or squeezing) of the colon (large intestine). Investigators are~     investigating whether octreotide can increase contraction and movement in the colon.~   "
126038|NCT01917760|"~     The purpose of this study is to determine upon administering GABA orally to a person how it~     is absorbed, distributed, as well as the drug's pharmacological effects on the body such as~     glucose levels, serum C-peptide and/or insulin levels (referred to as~     pharmacokinetics/pharmacodynamics). We will conduct experiments in normal subjects to address~     these questions.~   "
126039|NCT01917747|"~     Hearing loss is the most common sensory congenital disorder and this condition is diagnosable~     and treatable. Children that are born with hearing loss have to undergo several hearing tests~     to diagnose the condition and many families are delayed in receiving this testing or never~     obtain the needed testing. This research employs a new method for helping children with~     hearing loss receive timely care by using a patient navigator, who is someone who teaches and~     provides emotional/social support for the families of these children. The hypothesis of this~     study is that a patient navigator will hasten the timing of pediatric audiological testing,~     improve compliance with scheduled appointments, and expand parental knowledge of pediatric~     hearing loss.~   "
126040|NCT01917734|"~     The purpose of this study is to assesses the effectiveness of an integrated model for the~     management of severe acute malnutrition (IM-SAM) in India comprising facility- and~     community-based care and using locally-adapted protocols~   "
126079|NCT01917227|"~     Objective:Health videos and group education to allow patients to a correct understanding of~     diabetes and insulin treatment.~      Method:~      Standards and number of patients: The patients received subcutaneous insulin injection,~     estimated 30 people enrolled.~      Experimental Design and Methods:~        1. Screening out-patient treatment with insulin use, HbA1c> 8% or poor postprandial glucose~          (PPG)~        2. At the time of the visits, invite the patient to participate in the Video group~          education on insulin therapy By answering some questions about insulin injections, such~          as: do not know how to perform; afraid of the pain; fear of inconvenience, give patients~          time to complete the questionnaire.~   "
126080|NCT01917214|"~     This is a retrospective, non-interventional study which looks at the cohort of Renal Cell~     Carcinoma patients in a real life clinical setting and analyses into factors why these~     patients have been surviving for as long as 3-5 years unlike Clinical study where the~     survival is around 2 years.~      The factors which will be analysed include patient characteristics, dosage and adverse event~     management and tries to correlate these factors with survival.~   "
126041|NCT01917721|"~     Kawasaki disease (KD) affects infants and young children causing inflammation of the skin and~     blood vessels including the coronary arteries of the heart. Despite the currently available~     therapy, about one third of children develop enlargement of the coronary arteries that can~     lead to serious complications such as coronary artery stenosis, heart attack and even death.~      Kawasaki disease is the most common heart disease in children in the USA and it is especially~     common among the children of Hawaii. Every year, 50-90 children are diagnosed with KD in~     Hawaii and unfortunately there is no medication available to successfully prevent coronary~     artery damage in a subset of cases.~      During the first few weeks of the illness, cells of the immune system attack the coronary~     arteries and release a special substance (MMP) that is responsible for the coronary artery~     enlargement. There is a common antibiotic, doxycycline that can specifically block the action~     of this special substance (MMP). Research done on animals with KD showed that doxycycline was~     able to block this special substance and prevent enlargement of coronary arteries. Research~     in adults with enlargement of the main artery in their abdomen also showed that doxycycline~     may improve the outcome. Based on these studies doxycycline may be a promising therapy for~     children with KD, who develop enlargement of the coronary arteries.~      The investigators' proposed research study will assess the usefulness of doxycycline in~     preventing the progressive enlargement of coronary arteries in children with KD. The~     investigators plan to perform a small (pilot) study to evaluate how good is doxycycline in~     preventing coronary artery enlargement. The investigators will treat 25 children with KD and~     enlarged coronary arteries for two weeks with doxycycline and assess the change in coronary~     arteries as well as the blood levels of the special substance (MMP). If doxycycline proves to~     be beneficial in this small study, the investigators are going to design a large research~     study involving multiple institutions on Hawaii and the mainland and will recruit more~     children to be certain about the value of the proposed treatment. The investigators' proposal~     may change the treatment protocol of KD and could present a possible treatment for children~     with enlarged coronary arteries preventing potentially devastating consequences.~   "
126042|NCT01917708|"~     This is a single arm phase I study to assess the tolerability of abatacept when combined with~     cyclosporine and mycophenolate mofetil as graft versus host disease prophylaxis in children~     undergoing unrelated hematopoietic stem cell transplant for serious non-malignant diseases as~     well as to assess the immunological effects of abatacept.~   "
126043|NCT01917695|"~     The aim of this study is to establish the role of neoadjuvant chemotherapy and chemo~     irradiation in carcinoma cervix and to compare its results with the concurrent chemo~     irradiation in terms of overall survival, disease free survival and quality of life.~   "
126044|NCT01917682|"~     To collect data on the routine patterns of use, safety and effectiveness, including the~     clinical and technical performance of the CorPath 200 System, in the delivery and~     manipulation of coronary guidewires and stent/balloon catheters during PCI procedures.~   "
126045|NCT01917669|"~     The purpose of this research is to better understand how calcium and glucose may play a role~     in people developing diabetes. By doing this study, the investigator hopes to learn whether~     abnormal calcium and glucose responses in skin biopsies from healthy patients and patients~     with Type 2 diabetes can identify and predict patients at greatest risk for later~     complications.~   "
126046|NCT01917656|"~     This trial is conducted in Africa and Asia. The aim of the trial is to investigate the~     efficacy and safety of liraglutide versus sulphonylurea (SU) both in combination with~     metformin during Ramadan in subjects with type 2 diabetes (T2DM).~   "
126047|NCT01917643|"~     This study is intended to evaluate treatment effectiveness with budesonide/formoterol (BFC)~     and tiotropium tromide in patients new to ICS/LABA combination and LAMA therapies.~   "
126048|NCT01917630|"~     To determine the effects of 12 weeks administration of different dose levels of ALV003 on the~     mucosal lining of the small intestine and symptoms in celiac disease patients.~   "
126049|NCT01917617|"~     The objective of this study is to evaluate the safety and feasibility of oral rehydration~     therapy for short hydration in patients with biliary tract cancer who will undergo the~     chemotherapy including gemcitabine and cisplatin.~   "
126050|NCT01917604|"~     To test the null hypothesis that there are no differences in the outcomes between using an~     open or closed surgical method to expose canines that have become displaced in the roof of~     the mouth.~   "
126051|NCT01917591|"~     The objective is to determine, if healing of punch biopsy wounds treated with the fish skin~     derived MariGen Wound dressing is non-inferior to healing with wounds treated with pig~     intestines derived Oasis Sheet wound dressing. Secondary endpoints are: Incidence of~     erythema, Pain, Infection, Quantitative measurements of autoantibodies at baseline and 4~     weeks after start of treatment~   "
126052|NCT01917578|"~     The main clinical goal of NAC is to down-stage the primary tumor for BCS,yet BCS after NAC~     has been associated with significantly higher ipsilateral breast tumor recurrences.The~     accuracy of breast tumor excision in BCS can dramatically reduce IBTR.The main reseason of~     IBTR might be the uncertain shrinkage modes of the breast cancer after NAC.This clinical~     trial is firstly carried out to make clear the shrinkage modes of the primary tumor after 3~     cycles and whole cycles of NAC,respectively,with whole-mount serial section(WMSS) and~     three-dimensional(3D) pathological reconstruction of the residual tumor.The second objective~     is to investigate the predictive value of 3D MRI reconstruction for the shrinkage modes of~     the primary tumor after NAC.~   "
126053|NCT01917565|"~     The investigators hypothesize that when used by experienced anesthesiologists, Airtraq~     laryngoscope will increase the first-attempt success rate with shorter intubation times and~     more stable hemodynamic parameters.~   "
126054|NCT01917552|"~     multi-center, prospective, randomized, open-label phase III~   "
126055|NCT01917539|"~     Our primary aim is to determine whether pulsed light therapy (PLT) is effective in reducing~     symptoms and improving clinical stigmata of dry eye syndrome (DES) associated with meibomian~     gland dysfunction (MGD) in patients with facial rosacea (which includes ocular rosacea). The~     uses of PLT are for treatment of rosacea, hair removal, pigmented lesions, and skin~     telangiectasias. The risks include the potential for transient sunburn-like sensations (i.e.~     redness, burning sensation) and particularly if not used properly, the potential to cause~     burns, blistering, scarring, and pigmentary changes.~   "
126056|NCT01917526|"~     After general anesthesia, there are the risks for airway obstruction, hypoventilation,~     atelectasis, ventilation-perfusion mismatch, hypercarbia and hypoxemia,so oxygen supplement~     in PACU seems necessary.~      This study aim is to compare the two methods of oxygen supplement which are 1.nasal cannula~     at O2 flow 4 L/min. 2.oxygen mask with O2 flow 5 L/min. The hypothesis in this study is the 2~     methods can equally provide effective oxygen supplement to prevent anesthesia-related~     hypoxemia. Choosing nasal cannula would be reasonable because it is cheaper and more~     comfortable to patient.~   "
126057|NCT01917513|"~     The purpose of this study is to compare the adenoma detection rate of G-EYE™ high definition~     colonoscopy with that of standard high definition colonoscopy~   "
126103|NCT01916915|"~     Patients experience considerable amount of pain after cesarean section. The aim of this study~     is to investigate the effect of tramadol (an opioid pain killer) added to levobupivacaine (a~     local anesthetic) in continuous wound infusion (which is done by placing a catheter in the~     incision) after cesarean sections.~   "
126058|NCT01917500|"~     The objectives of this clinical trial is to validate a S/W application to compare the~     calculations of Hemodynamic parameters like Continuous blood pressure (BP) and Continuous~     cardiac output (CO). This Hemodynamic parameters are computed from Pulse Oximeter~     (PhotoPlethysmograph or PPG) signal with results obtained by NIBP intermittent measurements~     and Echocardiography. The first phase of the study will be done on 10 patients of the~     Cardiology dept.- Cardiac ICU, that have routine measurements of BP and CO using~     Echocardiography.~      The HeartBeat system combines an FDA/CE approved watch-like Pulse Oximeter for acquiring the~     data and a Smartphone S/W application that serves as the Hemodynamic calculator. The S/W~     application performs POST-PROCESSING of the PhotoPlethismoGraphic (PPG) signal (Normally the~     PPG signal in Pulse Oximeters is used only to compute heart rate and SpO2). The raw data is~     transferred from the watch oximeter to the smartphone using a standard Bluetooth protocol.~      The Post-processing uses wavelet signal processing to estimate and display certain~     Hemodynamic parameters like (Blood Pressure) BP and CO in a continuous and graphical way on a~     standard Android Smartphone. In addition to the standard heart rate and SpO2, the application~     displays the measured PPG signal and estimated continues BP and CO.~      HeartBeat is the only device that can non-invasively estimate Continuous BP and its Cardiac~     Output component and the resistance component in a mobile wearable device. Differentiating~     between these 2 components can play a major role in helping the doctor to understand the~     effect of cardiovascular medications and Lifestyle interventions.~   "
126059|NCT01917487|"~     The purpose of the study is to define the precision, accuracy and variability of the NBM-200~     system in non invasive blood Hemoglobin (Hb) measurements relative to the laboratory blood~     analyzer by comparing two consecutive Hb values obtained by the NBM system to venous values.~   "
126060|NCT01917474|"~     Headache is a frequently disabling disorder, which occurs in about 30% of the adult~     population, particularly in overweight/obese women. Aim of the study is to modify the~     nutritional habits of the patients and to evaluate the effects of a low lipid intake vs. a~     normal lipid diet on the incidence and severity of migraine crises. Moreover vascular~     reactivity will be evaluated in a randomly selected subgroup of patients. This randomized,~     cross-over intervention trial will be performed in about 150 patients, affected by migraine.~     Adherence to the diet, particularly regarding energy intake, percent of energy from lipids,~     carbohydrates and proteins will be carefully assessed at baseline and during the 2~     intervention periods~   "
126061|NCT01917461|"~     This is an observational prospective study of an in-vitro diagnostic (IVD) assay planned to~     enroll 632 subjects. The study will be conducted in two stages: Stage A is aimed at~     identifying individual biomarkers and constructing a multi-parametric diagnostic model,~     whereas Stage B is aimed at testing the multi-parametric diagnostic model using a fresh~     cohort of patients.~      A collection of clinical, radiological and laboratory data will be gathered in order to~     establish a final diagnosis. Blood samples will be analyzed and the levels of approximately~     700 and 250,000 biomarkers will be determined using immunoassays and molecular measurements~     respectively.~      A final diagnosis will be determined based on a majority decision of a panel of three or more~     independent physicians. Based on the final diagnosis, the accuracy of individual biomarkers~     and combined sets of biomarkers for differentiating between distinct groups of patients will~     be evaluated.~   "
126062|NCT01917448|"~     One-thirds of patients underwent video-assisted thorascopic surgery still have severe pain.~     Therefore we want to demonstrate weather 0.15 mg spinal morphine would reduce 24 hour~     postoperative requirement comparing to control group.~   "
126063|NCT01917435|"~     The aim of the study is to investigate the efficiency of the Video-stylet (Trachway ®) and~     the fiberoptic bronchoscopy in facilitation of nasotracheal intubation in limited mouth~     opening patients.~   "
126064|NCT01917422|"~     Dengue virus serological reagent, included antigen and antiserum, is a serum test for~     identification of serum antibodies to dengue virus.~   "
126065|NCT01917409|"~     The purpose of this study is to compare conventional laryngoscopy with video-stylet~     (Trachway) for nasotracheal intubation in patients undergoing oro-maxillo-facial surgery.~   "
126066|NCT01917396|"~     The researchers investigate that use of preoperative enema to the effect postoperative bowel~     gas passage.~   "
126067|NCT01917383|"~     The purpose of this study is to evaluate the intraocular pressure (IOP) lowering efficacy and~     the safety and tolerability profile of trabodenoson ophthalmic formulation compared to~     timolol maleate ophthalmic solution 0.5% in adults with ocular hypertension (OHT) or primary~     open-angle glaucoma (POAG) who are already receiving treatment with latanoprost ophthalmic~     solution 0.005% once every evening (QPM).~   "
126068|NCT01917370|"~     The investigators study the VEGF signaling in ICC cell lines／human tissues and its mechanism~     in HCC growth, proliferation and apoptosis.~   "
126069|NCT01917357|"~     This is a study to show that vaccination with three doses of Quinvaxem presented in Uniject~     is not inferior to vaccination with three doses of Quinvaxem presented in single dose vials,~     with respect to protection against all antibodies (anti-hepatitis B surface antibodies,~     anti-polyribosyl ribitol phosphate (PRP), anti-diphtheria, anti-tetanus and anti-Bordetella~     pertussis) one (1) month after completion of the 6-10-14 week vaccination course.~   "
126070|NCT01917344|"~     Newborn screening and early treatment prevent the most severe manifestations of~     phenylketonuria (PKU). However, executive functioning deficits, attention deficit disorder,~     slow processing speed, and visual-motor problems commonly occur. Many adults with this~     disorder also suffer depression and anxiety. Using advanced electroencephalogram (EEG) and~     magnetic resonance imaging (MRI) techniques, including novel MR spectroscopy (MRS) we hope to~     discover why this distinct constellation of deficits occurs in PKU. Adult subjects with PKU~     will undergo EEG and comprehensive MRI evaluations, including a novel method of MR~     spectroscopy to determine brain phenylalanine levels. In addition, they will receive~     neurological and neuropsychological examinations and dietary evaluation.~   "
126071|NCT01917331|"~     Randomized,double-blind,multicenter,multinational,parallel-group,Phase III study to~     demonstrate the superiority of the triple fixed combination of~     Beclometasone+Formoterol+Glycopyrrolate (BDP/FF/GB) administered via pMDI over the equivalent~     dose of Foster® in COPD (Chronic Obstructive Pulmonary Disease) patients after 52 weeks of~     treatment~   "
130560|NCT01858415|"~     The TriPollar is intended for non invasive treatment of facial wrinkles and rhytides. This~     study was designed in order to evaluate the safety and efficacy of the TriPollar.~   "
126081|NCT01917201|"~     The objective of this research is to assess the clinical results of implantation of different~     drug eluting stents under aggressive intravascular ultrasound (IVUS) guided all the way up~     to 24 months after operation and to establish the significance of the data of an optical~     coherent tomography (OCT) for the assessment of direct results of stenting and the degrees of~     endothelization of stent after 6 months.~      The following hypothesis formed the base for this study:~        -  IVUS guided intervention allows to improve the results and increase the safety of~          implantation drug eluting stents.~        -  Suboptimal results according to IVUS data can influence the follow up results of~          treatment.~        -  Suboptimal results according to OCT data, which are not revealed by IVUS, can influence~          the follow up results of treatment.~        -  The use of strategy of stenting with the achievement of optimal results under the~          intravascular methods of visualization allows to reduce the time of application of~          antiplatelet therapy.~        -  The modern limus-eluting stents do not differ in the follow up results in investigated~          criteria.~   "
126082|NCT01917188|"~     The initial aim of this study will be to assess current methods of heart failure (HF) patient~     education in terms of patient satisfaction, level of preparedness for home, and care provider~     satisfaction. The second aim will be to design and create a living with HF at home~     simulation session. The third aim will test the hypothesis that hospitalized HF patients who~     receive education in a simulation room in addition to usual HF education will have improved~     qualitative and quantitative outcomes as compared to those who do not receive the additional~     education support.~   "
126083|NCT01917175|"~     Set-up of a biobank for patients with an estimated date of infection seroconverters: store~     plasma and cells samples at initial contact and during follow-up for future analysis and~     analysis in international collaborative cohort seroconverters.~   "
126084|NCT01917162|"~     The purpose of this study is to compare the subjective performance of two daily disposable~     contact lenses with respect to comfort and handling.~   "
126085|NCT01917149|"~     Dilated cardiomyopathy (DCM) is a poorly understood cause of systolic heart failure and is~     the most common indication for heart transplantation worldwide. Despite advances in medical~     and device therapy, the 5-year mortality of patients with DCM remains high.~      Patients diagnosed of dilated cardiomyopathy with a NYHA functional class of II to IV and~     left ventricular ejection fraction(LVEF) <35% were selected for randomized controlled study~     of the efficacy and safety of high dose Renin-angiotensin system (RAS) inhibitor (benazepril~     or valsartan), in comparison with low dose RAS inhibitor(benazepril or valsartan) and~     standard beta-adrenergic blocker therapy (metoprolol). The primary endpoint was all cause~     death or admission for heart failure. Additional prespecified outcomes included all-cause~     death, cardiovascular death, all-cause admission, heart failure admission. Secondary~     cardiovascular outcomes included the changes from baseline to the last available observation~     after treatment in NYHA functional class, quality-of-life scores, LVEF, LVEDD, mitral~     regurgitation and wall-motion score index assessed by ECG. Adverse events were reported~     during in-hospital observation and follow-ups.~   "
126086|NCT01917136|"~     This study is looking at differences in metabolism and functional imaging between pulmonary~     hypertension subjects with normal right ventricular function and persistent right ventricular~     dysfunction. We will also measure right ventricular metabolic and structural changes using~     serial 11C-acetate and 18F-FDG PET/CT and cardiac MRI as response to treatment with~     ranolazine. Subjects undergo imaging procedures at week 0 and week 26 (optional for normal~     function patients). This is a companion imaging trial for patients who are eligible for the~     treatment trial entitled A randomized, double-blind, placebo controlled, multi-center study~     to assess the effect of ranolazine on outcomes in subjects with pulmonary hypertension and~     right ventricular dysfunction accompanied by a comparative study of cellular metabolism in~     subjects with pulmonary hypertension with and without right ventricular dysfunction.~     Subjects must enroll in companion treatment protocol to qualify for the imaging protocol.~   "
126087|NCT01917123|"~     In this randomized clinical trial before and after study we will assess the effect of~     L-citrulline malate on brachial index in patients with coronary heart disease based on their~     smoking history. Twenty patients with coronary heart disease with no history of diabetes or~     other chronic diseases and with no history of myocardial infarction in the last 6 months will~     participate in our trial.A written well-versed permission was attained from all patients. We~     will measure the brachial index tow times once before giving L-Citrulline malate and the~     other time after 2 weeks giving it.Patients receiving L-Citrulline malate as a 1 gram dry~     powder agent twice a day, that should in use with 250 mg dilute water .The patients will~     followed after 2 weeks by measuring brachial index which is our primary outcome measurement~     in this trial.We assumed that the brachial index in both smoker and non-smoker group of~     patients with coronary heart disease would change to normal or close to normal after giving 1~     gram L-citrulline malate twice a day for 2 weeks.~   "
126088|NCT01917110|"~     The purpose of the study is to quantify the effectiveness of CooperVision MiSight® (omafilcon~     A) soft (hydrophilic) contact lens in slowing the rate of progression of juvenile-onset~     myopia.~   "
126089|NCT01917097|"~     This is a retrospective chart review to evaluate the postoperative course of all pediatric~     patients admitted to the hospital following adenotonsillectomy over the past 24 months to~     evaluate the incidence of bradycardia in children who received dexmedetomidine~     intraoperatively and identify confounding factors which may be precipitating the bradycardia~     or potentiating the negative chronotropic effects of dexmedetomidine.~   "
126090|NCT01917084|"~     To determine if an exercise program of passive range of motion (ROM) is safe and feasible in~     infants with single ventricle (SV) physiology after their Norwood procedure.~   "
126091|NCT01917071|"~     Hypothesis: There is no difference in directional specific manipulation of the thoracic spine~     for patients with neck pain.~      Patients seeking physical therapy for neck pain routinely have their thoracic spine~     manipulated. This study seeks to determine if directional limitations in the spine can be~     specifically determined and treated to decrease neck pain.~   "
126403|NCT01912976|"~     Methyl aminolaevulinate photodynamic therapy (MAL-PDT) is an effective treatment for Bowen's~     disease (BD) of the lower extremities. Er:YAG ablative fractional laser (AFL) treatment~     removes the stratum corneum to increase MAL uptake and may improve efficacy. However, no~     studies have directly compared the efficacy of MAL-PDT with and without Er:YAG AFL in~     treating BD of the lower extremities in Asians.~   "
126092|NCT01917058|"~     The purpose of this study is to determine if receiving sub-cutaneous injections of a~     medication called abatacept causes regrowth of hair in people with alopecia areata.~      Among patients with alopecia areata, patients with worse disease are unlikely to have~     satisfactory outcomes with current therapies. Our hypothesis is that Abatacept will be~     effective therapy in moderate to severe alopecia areata by blocking re-activation of a~     special type of immunecell call a memory T-Cell (CD8+NKG2D+)thereby blocking the inflammatory~     response underlying alopecia areata.~   "
126093|NCT01917045|"~     The investigators noticed that Body Fat Ratio might have great influence on the efficacy of~     different lipid soluble anesthetics. The objective of this clinical trial was to compare the~     effect of that Body Fat Ratio on the efficacy of different lipid soluble anesthetics.~   "
126094|NCT01917032|"~     Objective: To acquire the local scientific evidence, to evaluate the effects of micronutrient~     Sprinkles™ powder, both the nutritional status and haematological values in the vulnerable~     preschool population, to corroborate the reported benefits of the experiences in other~     countries.~      Question: Will it improve the nutritional status and hematological levels after the home~     fortification with Sprinkles in children of two child care centres in the city of Medellin,~     in 2013?~      Hypothesis: At the end of intervention, hematologic levels and anthropometric indicators will~     be better in the intervention group with Sprinkles, compared with the placebo group.~      Design: Randomized clinical trial, triple-blind and placebo-controlled.~      Participants: Two groups of 50 children each, aged between 5 and 59 months, not anemic or~     with severe malnourished, full-time assistants to two children's centres that have the same~     alimentation menu.~      Intervention: The daily diet will be supplemented with sprinkles in one of the children's~     centres and will be compared anthropometric and hematological values before and after with a~     group receiving the same diet with placebo.~      Outcome measures: Nutritional status (anthropometric measures) and haematological values~     (hemoglobin, ferritin, transferrin and folate).~   "
126095|NCT01917019|"~     This is a multicenter study conducted in 3 parts. Part A is a double-blind placebo-controlled~     parallel-group period, and Part B and C are open-label extension periods. The primary~     objective of the double-blind study (Part A) is to assess the effect of Prolonged-Release~     Fampridine treatment on walking speed as measured by the T25FW (timed 25 foot walk) in~     Japanese participants with Multiple Sclerosis. The secondary objective of the double-blind~     portion of the study is to evaluate the safety and tolerability of prolonged-release~     Fampridine in this study population. The primary objective of the open-label extension study~     (Part B) is to evaluate the long-term safety profile of prolonged-release Fampridine. The~     primary objective of the additional open-label extension (Part C) is to provide participants~     who complete the study with continued access to prolonged-release fampridine until marketed~     drug can be used at the applicable site or until sponsor decision to discontinue the study.~   "
126096|NCT01917006|"~     This is a safety and efficacy study of BOTOX® (onabotulinumtoxinA) for the treatment of~     premature ejaculation in male patients.~   "
126097|NCT01916993|"~     The purpose of this research study is to: test the safety, tolerability, and pharmacokinetics~     (PK testing, the study of how the body absorbs, distributes, breaks down and eliminates a~     drug) of a single dose of the investigational study drug NBI-98854 in subjects with normal~     hepatic function or mild, moderate, or severe hepatic impairment.~   "
126098|NCT01916980|"~     This is an efficacy and safety study of up to 12 weeks of desloratadine in Japanese~     participants with eczema/dermatitis and dermal pruritus. The primary hypothesis of this study~     is that the sum of the daytime and nighttime pruritus/itch scores for both the~     eczema/dermatitis group and the dermal pruritus group will be significantly improved at Week~     2 compared to Baseline.~   "
126099|NCT01916967|"~     This is a study to evaluate the efficacy and safety of desloratadine (MK-4117) in Japanese~     participants with chronic urticaria. The primary hypothesis is that the efficacy of~     desloratadine 10 mg and 5 mg is superior to placebo as based on the change from Baseline in~     the sum score of pruritus/itch and rash as assessed by the Investigator at Week 2.~   "
126100|NCT01916954|"~     Malaria in pregnancy is a major cause of maternal and newborn morbidity and mortality in~     sub-Saharan Africa]. Effective antimalarial preventive and treatment regimens can~     significantly reduce malaria-related morbidity and mortality in the mother and baby. However,~     therapeutic choices are limited by concerns about possible toxicity to the fetus and because~     of these concerns pregnant women are normally excluded from clinical trials. This, combined~     with the lack of adverse events reporting system, results in a scarcity of data on drug~     safety and efficacy in pregnancy. Moreover, changes in the maternal physiology in pregnancy~     often alter the pharmacokinetic of drugs. Artemether-lumefantrine (ALN) is a highly~     efficacious artemisinin-based combination therapy approved by the World Health Organisation~     for use in the 2nd and 3rd trimesters, although it is still infrequently used in pregnancy~     and there is uncertainty as to the optimum dose. The pharmacokinetics of ALN are altered in~     pregnancy, resulting in reduced plasma concentrations and while the standard adult dose is~     still effective in high transmission settings, where pregnant women have higher levels of~     immunity, efficacy is reduced significantly in low transmission settings where women have~     lower levels of immunity. Inadequate antimalarial treatment dosing in pregnancy risks~     treatment failure or breakthrough infection and exposure of malaria parasites to~     sub-therapeutic drug concentrations thus selecting for drug resistance.~   "
126101|NCT01916941|"~     The study uses neurobiological measures through brain imaging, neuropsychological measures,~     and selfreport measures to try to understand how an effective treatment for alcoholism works.~     On the whole, less than 50% of people with alcoholism get better with treatment. This study~     will help researchers develop better treatments for alcoholism because if the investigators~     know why the treatments the investigators use are working, and in whom the treatments work~     best, then the investigators may be able to make treatment more effective by targeting~     treatments to individuals who would be most likely to benefit and by guiding development of~     more effective treatments in the future.~   "
126102|NCT01916928|"~     Women presenting to Washington Hospital Center with fetal loss would be offered participation~     in the study. The objective is to determine if ccffDNA obtained from maternal blood is~     present in the setting of missed abortion or fetal demise.~      The investigators primary hypothesis is that cell free fetal DNA will be present in maternal~     blood in the presence of a failed pregnancy.~   "
126104|NCT01916902|"~     Subjects presenting with probable acute coronary syndromes scheduled for cardiac~     catheterization will be enrolled in this study. Consented subjects will be randomized to~     receive ticagrelor started with a loading dose immediately after enrollment versus receiving~     a loading dose of ticagrelor during cardiac catheterization after diagnostic angiography but~     prior to stenting. Optical coherence tomography (OCT) will be performed after stenting and~     the volume of thrombus within the new stent will be measured and compared between the groups.~   "
126105|NCT01916889|"~     Delirium is a serious medical condition associated with increased mortality, longer hospital~     stay, increased rates of institutionalisation, and declines in post-admission functionality.~     Despite the prognostic utility of diagnosing delirium and its utility as an important~     indicator of health quality in elderly patients in developed countries, it is not routinely~     screened for in many busy general medical in-patient settings, especially in developing~     countries. Unpublished data from a recent study of general medical in-patients in Groote~     Schuur Hospital, Cape Town, South Africa, found that no patients admitted during an 8-week~     period received any formal cognitive testing or had documentation of the presence/absence of~     delirium in routine clinical notes. This under-recognition is largely the result of the~     length and complexity of available delirium diagnostic tools e.g. Mini-mental state exam~     (MMSE), although the perceived lack of clinical importance and conflicting results about~     specific treatment modalities also contribute.~      The investigators recently developed the simple 4-question RACY delirium screening tool for~     use in general medical in-patients. Preliminary data show the test to be simple and effective~     with a sensitivity and specificity of 78% and 85% respectively using a ROC-selected cut-point~     of RACY≤2. The investigators hypothesis that the RACY screening tool has the potential to be~     a simple and effective bedside delirium diagnostic instrument for use in non-geriatric, busy~     general medical in-patient settings. This study is a two-centre validation study to evaluate~     the diagnostic accuracy of this tool.~   "
126106|NCT01916876|"~     The post discharge time is a vulnerable time for general medical in-patients, with high rates~     of adverse events that may cause unnecessary readmissions and even death. A recent study of~     415 patients discharged from the general medical wards at Groote Schuur Hospital,~     demonstrated a very high 12 month mortality of 35%. The majority of these deaths were~     classified as unexpected. The reasons for this were not further examined, but it was~     speculated, given the authors' knowledge of the public sector in Cape Town, that three~     related factors contribute significantly to this early mortality: i) a lack of continuity of~     care, with patients not necessarily accessing the primary care support treatment that they~     need or being able to access early post discharge follow-up (for example for anti-retroviral~     or anti-tuberculous care); ii) the inability of primary care to deal with the complex nature~     of the discharged patients, most whom have significant co-morbid disease; iii) A lack of~     optimisation of therapy for chronic disease after acute discharge.~      The investigators hypothesise that an integrated post-discharge transitional care package,~     which includes an early medical specialist follow-up in the first 3 months after hospital~     discharge will decrease the 6- and 12-month mortality and re-admission rate amongst general~     medical hospital admissions in Cape Town, South Africa. Our study will compare an integrated~     package, suitable to implementation if effective, with current standard discharge packages.~   "
126107|NCT01916863|"~     The purpose of this study is to assess the effect of LX4211 and the comparator drug~     canagliflozin on intestinal glucose absorption and metabolism after a single dose in healthy~     subjects in comparison to placebo.~   "
126108|NCT01916850|"~     The primary objective of this study is to evaluate the safety and tolerability of multiple~     oral doses of LX4211 400 mg and LX4211 800 mg (administered once daily for 10 consecutive~     days) in healthy subjects.~   "
126109|NCT01916837|"~     In this prospective study the investigators sought to evaluate the feasibility of using the~     genomic signature - Genomic Grade Index (GGI) - in routine clinical practice and its impact~     on treatment recommendations.~   "
126110|NCT01916824|"~     In this trial, fifty participants with current major depressive disorder who are not~     receiving an antidepressant medication and fifty healthy controls will complete~     questionnaires and computerized tasks to assess their decision-making styles. There will be~     three visits for depressed patients and two for healthy controls (the first and third~     visits). The first visit will involve interviews and questionnaires to assess the~     participant's level of depression, medical history and quality of life. Participants will~     then complete the decision-making tasks, and will earn between $5-40 based on their choices,~     in order to make the decisions on the computer tasks financially meaningful. At the~     completion of this visit, depressed patients will be prescribed an FDA-approved~     antidepressant, chosen in consultation with the treating psychiatrist. Patients will be~     responsible for paying for the prescription themselves. After two weeks on the medication,~     the patient will be seen for a follow-up visit to ensure tolerability of the medicine. After~     six weeks on the medicine, patients and healthy controls will return to repeat the~     questionnaires and the computer based decision-making tasks, and will again earn between~     $5-40 based on their performance.~   "
126111|NCT01916811|"~     The mian purpose of this study is to analysis the imaging changes in 3.0T MRI of lumbar small~     joints, intervertebral discs, ligaments and muscle in hospital nurses first suffered with low~     back pain.~   "
126112|NCT01916798|"~     Intralipid can suppress natural killer cells that are known to be involve in repeated~     implantation failure and recurrent miscarriages.Intralipid is made of purified soybean oil,~     egg phospholipids, glycerol and water. It provides essential fatty acids, linoleic acid,~     omega- 3 and 6 fatty acids and alpha-linolenic acid. The effects of Intralipid in suppressing~     natural killer cell activity (NKa) were found to be comparable to intravenous immunoglobulin~     (IVIG) by laboratory experiments.We will study the effect of intralipid infusion on the~     pregnancy outcome of women aged 35-40 years with history of repeated implantation failure of~     miscarriage and who have positive peripheral blood natural killer cells~   "
126123|NCT01916655|"~     OSA is a major chronic condition affecting the quality of life of millions of Americans. Per~     the Institute of Medicine new treatment adherence strategies are needed to help improve the~     quality of care, reduce social and economic costs, and help those with chronic conditions~     (such as OSA) live healthier and more productive lives through better management of their~     conditions. Using an mHealth tool to help deliver the investigators' Self-Management~     intervention and improve the frequency and quality of patient-provider communications is a~     central component of that discovery process.~   "
126113|NCT01916785|"~     This protocol is a multicentric interventional phase II study from the French CML Intergroup~     (FILMC).~      The core of the protocol is to explore the efficacy and safety of an optimization strategy~     consisting in the modulation of the dasatinib daily dose according to the results of repeated~     plasmatic levels of dasatinib.~      The objective of this strategy is to improve the overall results of the treatment of early~     CP-CML in order to avoid the development of resistance and BCR-ABL tyrosine kinase mutations.~      The study will be conducted in selected FILMC and Canadian centers.~      The study is sponsored by the Hôpitaux de Versailles and supported by Bristol-Myers Squibb.~     The dasatinib treatment will be provided by Bristol-Myers Squibb until marketing~     authorization is granted in that indication.~   "
126114|NCT01916772|"~     To observe the natural history of cherubism.~   "
126115|NCT01916759|"~     To use a systems biological approach to study the molecular signatures of innate and adaptive~     responses to vaccination in a HIV infected versus uninfected adult population in Kampala,~     Uganda.~   "
126116|NCT01916746|"~     The aim of this study is to further demonstrate the safety and effectiveness of transvaginal~     resection of pregnancy tissue in the treatment of Caesarean Scar Pregnancy (CSP).~   "
126117|NCT01916733|"~     The aim of this study is to examine the effect of moderate glucose (blood sugar) control in~     diabetic and non-diabetic patients undergoing leg bypass surgery (LEB) or open abdominal~     aortic aneurysm (AAA) repair. We hypothesize that use of Fletcher Allen Health Care's current~     insulin infusion strategy will result in improved blood sugar control which will translate~     into decreased postoperative morbidity (fewer complications) and better long term outcomes~     when compared to patient outcomes at other institutions which utilize other blood sugar~     management strategies.~   "
126118|NCT01916720|"~     The primary objective is to determine Lp-PLA2 activity in atherosclerotic carotid plaques~     after 14 (+/-4) days treatment with darapladib, compared to placebo. Secondary objectives~     include determination of the change in Lp-PLA2 activity in blood, Lp-PLA2 mass in blood and~     plaque, specified biomarkers in blood and plaque and their respective correlation's with~     Lp-PLA2. In addition, the study aims to characterise the PK/PD of repeat oral doses of~     SB-480848, and safety and tolerability in this population.~   "
126119|NCT01916707|"~     Hospitalized trauma patients frequently suffer from blood clots in the legs or lungs. To~     minimize the risk of these blood clots developing, patients may be given a blood-thinner drug~     such as enoxaparin.~      Until now, a set dose of enoxaparin has been given to a patient, regardless of his or her~     weight. However, a recent study suggests that for obese patients, the set dose may be~     inadequate. The purpose of this study is to evaluate whether or not a dose of enoxaparin that~     is based on the patient's weight will help to prevent the formation of blood clots.~      The information gathered through this study will help doctors to understand the best way to~     prevent blood clots in future trauma patients. The potential risks of participating in this~     study include the minor risks of blood draws and ultrasounds, as well as the more significant~     risks of bleeding as a side effect of the enoxaparin.~   "
126120|NCT01916694|"~     Diabetes in pregnancy (gestational diabetes) is becoming more common. It can lead to problems~     for both mothers-to-be and their babies such as causing a large baby and difficult birth.~     Gestational diabetes in the mother may also lead to effects on the long term health of the~     baby.~      Most people today use mobile phones. Our research is looking at using a mobile phone app to~     help with diabetes care in pregnancy. In particular, the investigators are using phones which~     connect to the standard blood glucose monitoring machines given to all women with gestational~     diabetes to see if sending the hospital team blood test results between clinic appointments~     can result in the need for fewer clinic visits. The investigators are also testing to see how~     acceptable using mobile phones in this way, is to our patients and that the control of the~     blood glucose and outcomes for the mother and baby are at least as good as standard care.~      The investigators are planning to recruit 200 women who receive care for their gestational~     diabetes at the Oxford University Hospitals NHS (National Health Service) Trust. They will be~     randomised so that 100 will receive standard care, and 100 will have a mobile phone app~     linked to the blood glucose machines to send blood glucose readings directly to the diabetes~     care team to review.~      Both groups will be asked to test their blood glucose levels at home regularly with a~     glucometer. All participants will also be given lifestyle advice to reduce the chance they~     will need medication. Blood glucose control will be measured also by the percentage of~     glycated hemoglobin (HbA1c) at the time of diagnosis of gestational diabetes and before~     delivery.~   "
126121|NCT01916681|"~     The percentage of women undergoing an induction of labor (IOL) is estimated to be 20% and~     continues to rise. Simultaneously, the cesarean delivery (CD) rate has continued to increase~     (2). Induction is a known risk factor for CD. Despite numerous studies evaluating time~     periods to define a failed IOL, there are no guidelines or accepted definitions of when to~     call an IOL failed given the incremental gain in vaginal delivery when IOL is prolonged.~     While decreasing the CD rate is an important primary focus in obstetrics, attention must also~     be paid to the overall length of labor given that prolonged labor is associated with adverse~     maternal and neonatal outcomes. Furthermore, a prolonged labor is associated with an increase~     in direct hospital costs and healthcare utilization. The use of cervical ripening agents,~     such as vaginal prostaglandin and mechanical dilators, has been demonstrated to reduce labor~     time and CD rate. In addition to specific individual agents, certain dosing and regimens for~     IOL and active labor have been compared to evaluate whether a particular dose or regimen can~     decrease the length of labor and decrease the CD rate. Most of these regimens; however, focus~     on individual induction agents and few have compared the efficacy of using more than one~     agent simultaneously. Given the associated risks of prolonged labor and limited data~     evaluating the use of combined cervical ripening agents, our objective is to evaluate the~     difference in time to delivery among women who undergo an IOL with four different methods.~   "
126122|NCT01916668|"~     Observational evidence indicates that intradialytic hypertension is associated with high~     morbidity & mortality. The investigators impression is that this problem may be more~     prevalent than initially suspected. To the investigators knowledge, there are no studies on~     intradialytic hypertension in the South African haemodialysis population.~   "
126124|NCT01916642|"~     IV lidocaine administration can reduce the minimal amount of Etomidate and time for induction~     of anesthesia.~   "
126126|NCT01916616|"~     Vocal Cord Dysfunction (VCD) is characterized by involuntary closure of the vocal cords while~     inhaling. Children and adolescents with VCD may experience multiple symptoms, including~     difficulty breathing, coughing, wheezing, neck tightness, and voice changes. There is limited~     information on optimal management of VCD. In our proposed study, we will use~     cognitive-behavioral therapy (CBT) techniques to change how patients respond to their VCD~     symptoms. Measurements of airflow during breathing as well as symptom frequency and intensity~     will be examined prior to and following a series of four therapy sessions with a clinical~     psychologist that are focused on teaching patients strategies to decrease symptom reactivity.~   "
126127|NCT01916603|"~     NCDs are observed mostly in adults, however there is strong evidence that suggests NCDs~     origin early in life, thus the first 1000 days of life (conception to age 2yrs). Studies show~     that maternal BMI before conception and during pregnancy predict future risk of obesity and~     associated metabolic conditions in both mother and offspring. Weight gain during the first~     two years of life is also critical in defining the infant's predisposition to obesity during~     adulthood. Objective: to assess the effectiveness of delivering a primary health care~     intervention to enhance compliance with updated nutrition and health care (diet, physical~     activity and breastfeeding) standards from early pregnancy through the first year of life.~     Methods: cluster randomized controlled trial (CRCT), designed as a public health intervention~     program effectiveness study (i.e. intervention will be available through the established~     national health system under standard operating conditions). A cluster unit will be a primary~     health care centers (PHCC) in South-East Santiago 12 PHCC will be randomly allocated to:~     enhanced nutrition and health care (intervention group) or routine nutrition and health care~     (control group).We will recruit 200 women in each of 12 PHCC; assuming a 20% loss to f-up we~     will complete 960 women per arm. After randomization, pregnant women in the intervention~     PHCCs starting at their first pre-natal visit (< 15 wks.) will receive, diet and physical~     activity (PA) counseling-support based on updated recommendations and monitoring goals for~     weight gain & glycemic control and breastfeeding (BF) promotion till 12 m postpartum.~     Pregnant women who attend control PHCCs will receive routine antenatal care according to~     national guidelines. Expected results: participants in the intervention PHCCs will benefit by~     achieving adequate nutritional status & metabolic control, during and early after, pregnancy~     as well as adequate infant growth & development as a result of improved nutrition and health~     care practices. The results will likely be generalizable through the primary health care~     system; considering this is a program effectiveness trial conducted under real life~     conditions . Additionally, we will include specific ancillary mechanistic projects to better~     characterize the intervention and its impact.~   "
126128|NCT01916590|"~     Both single shot femoral nerve block and continuous femoral nerve block with catheter have~     been shown to be effective for pain control after anterior cruciate ligament reconstruction~     (ACLR). Continuous femoral nerve block may be the more effective of the two in reducing pain~     scores and opioid consumption for the first 48 hours postoperatively.~   "
126129|NCT01916577|"~     The purpose of this study is to determine if the drug Plerixafor (Mozobil) can lead to~     clinically relevant efflux of CD117+ stem cells from the bone marrow to the peripheral blood~     of normal controls and patients awaiting lung transplantation. The investigator's hypothesis~     is that Plerixafor (Mozobil) will lead to significant mobilization of CD117+ stem cells to~     the peripheral blood.~   "
126130|NCT01916564|"~     This study aims to compare split-dose vs. same-morning whole-dose of 2-litre PEG-ELS plus~     bisacodyl for bowel preparation for morning outpatient colonoscopy.~   "
126131|NCT01916538|"~     The Anorexia Nervosa Genetics Initiative (ANGI) is the largest and most rigorous genetic~     investigation of eating disorders ever conducted. Researchers in the United States, Sweden,~     Australia, and Denmark will collect clinical information and blood samples from over 13,000~     individuals with anorexia nervosa and individuals without an eating disorder.~      ANGI represents a global effort to detect genetic variation that contributes to this~     potentially life-threatening illness. The goal of the research study is to transform~     knowledge about the causes of eating disorders to work toward greater understanding and~     ultimately a cure.~      If you have suffered from anorexia nervosa at any point in your life, you can help us achieve~     this goal. Your contribution would include a brief questionnaire and a blood sample. If you~     have never had anorexia nervosa, but still want to contribute, we invite your participation~     as well.~   "
126132|NCT01916525|"~     The objective of this multidisciplinary study is to employ health-economic evaluation in~     determining the health benefits achieved with exercise-based cardiac rehabilitation and the~     costs derived from it compared with conventional post-acute care of cardiac patients in the~     Finnish health care system.~   "
126133|NCT01916512|"~     The aim of this study is to determine whether high high density~     lipoprotein-cholesterol(HDL-C) level and low Cholesteryl Ester Transfer Protein(CETP)~     activity is atherogenic or not in subjects who received health checkups. We investigate the~     association between CETP activities and the severity of atherosclerosis assessed by~     intima-media thickness (IMT) and compare the atherogenic change between in subjects with high~     HDL-C level, low HDL-C level, high CETP activities and low CETP activities by examining the~     morbidity rate of atherogenic diseases, the rate of ischemic electrocardiography(ECG) change,~     Calc Score of artery from chest X-ray, Ankle Brachial Index/Pulse Wave Velocity and various~     serum atherogenic markers. And we also examine the correlation between normal lipid profile~     and concentration, activity and function of surface lipoprotein in subjects with variety of~     lipoprotein levels, including patients with hyper-LDL-cholesterolemia,~     hyper-HDL-cholesterolemia with low or no CETP activity, patients with high level of remnant~     cholesterol or hyperlipoproteinemia of apolipoprotein(Apo)B-48.~   "
126134|NCT01916499|"~     This study involves adolescents operated with arterial switch procedure for transposition of~     the great arteries during the neonatal period. The purpose is to evaluate the coronary~     arteries and direct and indirect findings of coronary artery disease/complications with 3~     tesla magnetic resonance imaging.~   "
126135|NCT01916486|"~     The investigators will conduct a randomized controlled trial study to provide preliminary~     evidence of efficacy of exercise training or a complex mental and social activities program~     for improving cognitive function in older adults with chronic stroke, compared with a stretch~     and relaxation program.~   "
126136|NCT01916473|"~     Study Hypothesis: The analgesic requirements and pain scores postoperatively differ between~     the epidural and continuous wound infusion techniques.~   "
126214|NCT01915446|"~     This study aims to investigate the predictive value of novel biomarkers and contrast-enhanced~     ultrasonography for early detection of abdominal end-organ (kidney and intestinum)~     hypoperfusion and ischemia in patients undergoing endovascular aortic repair (EVAR) for~     aortic aneurysm or dissection. In this context, patients will be monitored for renal~     biomarkers (TIMP-2, IGFBP7) and intestinal biomarkers (plasmatic intestinal fatty acid~     binding protein (i-FABP)) and local tissue perfusion will be assessed using contrast-enhanced~     ultrasonography (CEUS).~      The ultimate goal of this study is an early identification of patients developing one or both~     of these complications, which may facilitate a timely intervention to improve outcome.~   "
126137|NCT01916460|"~     Patients who empty their stomach slowly may have what we call Slow gastric emptying or~     gastroparesis. These patients can have some changes in the thickness of their stomach wall.~     In addition, they may have loss of some important nerve cells in their stomach muscles. The~     loss of these cells can cause slow emptying of the stomach. Obtaining a sample from the~     stomach wall to examine the loss of these cells can help in diagnosing gastroparesis. Up to~     now, the only way to obtain a tissue sample from the stomach muscle was to undergo an~     operation in the surgery suite and be hospitalized for several days after the procedure.~     Usually, we obtain this sample while these patients are having a surgery for another purpose~     such as placement of a gastric stimulator (a machine which is inserted in the stomach wall to~     control the stomach rhythm and thus help the stomach to empty faster). Endoscopic ultrasound~     is an endoscope (a tube with a source of light and ultrasound installed in the tip of the~     tube) that can measure how thick the stomach wall is and can provide sample biopsies of the~     stomach wall which can be studied for the loss of these specialized muscles and cells.~      We are proposing that samples obtained by the endoscopic ultrasound can be sufficient to~     diagnose gastroparesis and can replace the need for obtaining samples by surgery.~     Endoscopic ultrasound is an outpatient procedure which is not as invasive as surgery.~   "
126138|NCT01916447|"~     The purpose of this study is to investigate the safety and determine the maximum tolerated~     dose of TAS-102 administered in combination with CPT-11 in patients with advanced~     gastrointestinal tumors.~   "
126139|NCT01916434|"~     Consumption of fish can help to prevent cardiovascular disease. The precise way in which fish~     is beneficial is not fully understood. This is important to find out as fish consists of a~     complex mixture of fatty acids and micronutrients such as vitamin D and selenium that could~     individually, or collectively, be responsible for the beneficial effects.~      Fish farming in Scotland is playing an increasingly important role in the provision of fish~     for human consumption. But issues with sustainability of raw materials are requiring fish~     farming to reformulate fish diets, which may affect the levels of beneficial omega-3 fatty~     acids and other components in fish.~      In this study we will be comparing the long-term health effects of eating two portions a week~     of Scottish salmon raised on a traditional fish diet versus eating two portions a week of~     Scottish salmon raised on a more sustainable fish diet. In addition, we will be looking at~     differences in health outcomes when eating two portions a week of either Scottish salmon,~     compared with eating no fish at all.~   "
126140|NCT01916421|"~     Obtaining a sample from a lesion in the gastrointestinal tract by endoscopic ultrasound (a~     flexible tube with a camera and small ultrasound machine at its end )requires the use of a~     needle for taking the sample from the lesion or what we call Fine needle aspiration (FNA).~     Currently, FNA is done by three commercially available needles. These needles are used~     routinely in our institution for FNA. The data regarding the safety and the successfulness of~     any of these needles are lacking. We sought to compare all three commercially available~     needles in a prospective manner.~   "
126141|NCT01916408|"~     The aim of the present study is to investigate changes in inflammatory status and incidence~     of infection after extreme aerobic physical stress (participation in a marathon). In~     addition, the impact of marathon running on the hemostasis and muscular state will be~     evaluated. Changes at the inflammatory, muscular, and rheological level will be related to~     ingestion of oral hydrolytic enzymes and bioflavonoids.~   "
126142|NCT01916395|"~     The primary objective is to determine whether inflammatory markers, such as C-Reactive~     Protein (CRP), Calcitonin Gene-Related Peptide (CGRP), Vasoactive Intestinal Polypeptide~     (VIP), or Substance P (SP) are reduced in patients having a migraine headache when treated~     with Imitrex or Treximet.~      The secondary objective is to determine the effects of Imitrex and Treximet on C-Reactive~     Protein (CRP) in patients with active migraine headaches.~   "
126143|NCT01916382|"~     This is a proposal to develop the orphan designated drug, nitisinone, for the treatment of a~     rare Mendelian disease, Alkaptonuria (AKU). Thanks to our existing successful fundamental and~     clinical research (cell models, animal models, natural history studies), we are now ready for~     this final stage of clinical development of nitisinone for AKU: a phase 3 clinical trial to~     prove efficacy. The results of DevelopAKUre will allow us to make the case to the European~     Medicines Agency for marketing authorisation of nitisinone for AKU, thereby contributing to~     the goal of the International Rare Diseases Research Consortium of developing 200 new~     therapies by 2020.~   "
126144|NCT01916369|"~     The primary objective of the Phase I ascending dose trial is to investigate the safety and~     tolerability of intramuscular (gastrocnemius) injections of human neural stem cell product,~     CTX, in patients with peripheral arterial disease (Fontaine Stage II through IV). This trial~     is based on independent preclinical data from a leading academic research institution that~     has been submitted for publication. Inclusion of patients with Fontaine Stage II is justified~     as these patients have a lower incidence of background events and will facilitate distinction~     between events which are possibly intervention-related versus spontaneous events associated~     with underlying advanced atherosclerosis. The trial is designed to treat 9-18 patients and~     evaluate safety measures over a 12 month follow-up period.~   "
126145|NCT01916356|"~     The purpose of this study is to determine the effectiveness of an online informational video~     in improving knowledge about infertility in couples experiencing problems conceiving. A pilot~     study will be conducted with first and second year medical students.~   "
126157|NCT01916200|"~     This is an open label, randomized, add-on, 8 weeks multicentre study to evaluate the efficacy~     and safety of paroxetine Controlled Release (CR) in patients with Major Depressive Disorder~     (MDD) comorbid Irritable Bowel Syndrome (IBS).~      Subjects will be patients who are referred to the outpatient or inpatient clinic of~     gastroenterology departments of province level general hospitals in China. All subjects~     present with irritable bowel syndrome according to ROME III, and also are diagnosed with MDD~     by Mini-International Neuropsychiatric Interview (MINI). All subjects will provide written~     informed consent prior to participating in the study. Subjects will be assessed for~     eligibility at a screening visit, with eligible patients returning for a assessment within 1~     week, at which time they will randomly enter into paroxetine CR (12.5mg/d, flexible dose:~     12.5-50mg/d) plus IBS regular treatment or IBS regular treatment only. Subjects will be~     evaluated at weeks 2 (Day 14), 4 (Day 28), 6 (Day 42) and 8 (Day 56), for a total of 5 study~     treatment visits.~   "
126146|NCT01916343|"~     Gynecologists are currently using laparoscopy to perform many surgeries traditionally~     approached by laparotomy. The technical skills required for laparoscopic surgery are~     different than the skills required for laparotomy, causing a prolonged learning curve.~     Currently there is no standardized laparoscopy curriculum for gynecology residents. This~     study aims to develop a specific evidence-based surgical skills gynecologic curriculum that~     could be instituted in residency programs at a national and international level. The~     investigators will then validate the curriculum using Obstetrics and Gynecology residents~     through a cognitive examination, a technical skills examination, and a video recording of~     performance in the operating room.~      HYPOTHESIS: The investigators aim is to design a standardized evidence-based comprehensive~     laparoscopic curriculum that focuses on cognitive knowledge, surgical skills, and team~     training exercises. The investigators hypothesize that residents in the experimental~     curriculum-trained group will perform better than the residents in the traditional residency~     curriculum-trained group on a cognitive examination, a technical skills examination, and in~     the operating room. The operating room performance will be judged by blinded experts on a~     previously validated evaluation tool.~   "
126147|NCT01916330|"~     Pharmacokinetics analysis and development of pharmacokinetics model in pregnancy women and~     fetus~   "
126148|NCT01916317|"~     Voltage Gated Sodium Channels Over the years, there is more evidence that ionic channels are~     involved in the oncogenic process. Among these, voltage gated sodium channels (VGSC)~     expressed in non-nervous or non-muscular organs are often associated with the metastatic~     behavior of different cancers.~      Expression of VGSCs has been reported both in vitro and/or in vivo in a range of human~     carcinomas, including breast cancer Ion channels are major signaling molecules expressed in a~     wide variety of tissues. They are involved in determining a variety of cellular functions~     like proliferation, solute transport, volume control, enzyme activity, secretion, invasion,~     gene-expression, excitation-contraction coupling, and intercellular communication.4 VGSC~     activity contributes to much cellular behavior integral to metastasis, including cellular~     process extension, lateral motility and galvanotaxis, transverse invasion, and secretory~     membrane activity.~      A correlation between Na transport and oncogenesis has been widely reported in literature. In~     1980, transformed mouse mammary cells were shown to have 3-fold higher intra-cellular sodium~     content than untransformed cells.5 Additionally evidence suggest that increasing the inward~     sodium current through voltage gated sodium channels increased the invasive capacity of~     breast cancer.6 Also, growth and proliferation of mammary adenocarcinoma cells can be~     inhibited by Amiloride suggesting that epithelial Na channels (ENaC) activity is correlated~     with proliferation of breast cancer cells~      Current evidence suggests that VGSC activity is necessary and sufficient for cancer cell~     invasiveness8. A recent in vitro study has shown that the human MDA MB 231 breast cancer cell~     line expressed functional VGSCs9. However, the molecular nature of the VGSC and its~     functional relevance to breast cancer in vivo are currently under study.~      Surgical operations for cancer have been reported to induce dissemination of cancer cells~     into surrounding tissues or into the circulation10,11and infiltration anesthetics can inhibit~     immune response12-14. Although the mechanism remains to be elucidated, infiltration~     anesthetics such as lidocaine have membrane- stabilizing action (Seeman, 1972) and these~     agents could have direct effects on cancer cells. Therefore, it is important to clarify the~     effects of infiltration anesthetics on behavior of the tumor cells.~      Commonly used local anesthetic agents inhibit the VGSCs and also possess a unique membrane~     stabilizing action through other unknown mechanisms. A study by Mammota et al 15 reported~     that lignocaine, effectively inhibited the invasive ability of human cancer (HT1080, HOS, and~     RPMI-7951) cells at concentrations used in surgical operations (5-20 mM). Lidocaine reduced~     the invasion ability of these cells by partly inhibiting the shedding of HB-EGF from the cell~     surface and modulation of intracellular Ca2+ concentration contributed to this action. In~     addition, lidocaine (5-30 mM) infiltrated around the inoculation site, inhibited pulmonary~     metastases of murine osteosarcoma (LM 8) cells in vivo.~      Dose of lidocaine15:~      40 mM (1%) lidocaine is usually used for infiltration anesthesia for surgical operations.~     Lower concentrations (1-20mM) of lidocaine were sufficient to suppress the invasive ability~     of cancer cells14. One mM lidocaine inhibited the invasive ability of HT1080 cells by about~     50%, and 20 mM lidocaine inhibited the invasion ability completely. Lidocaine also inhibited~     dose-dependently the invasive ability of HOS and RPMI-7951 cells, although it was less~     effective on HOS cells. Lignocaine exerts its anesthetic action by obstructing the sodium~     channel 16 however, 10 mMof tetrodotoxin (TTX), a specific sodium channel inhibitor, had~     little effect on the invasive ability of HT1080 cells. Ten mM lidocaine-N-ethylbromide (NEB),~     which does not cross the cell membrane, also had little effect on the invasive ability of the~     cells.~      Objectives~      Primary Objective:~      • To assess the in-vivo ability of local anesthetics agents like lignocaine to decrease the~     dissemination of cancer cells during surgery and improve the disease free interval~      Secondary Objective~      • To assess the in-vivo ability of local anesthetics agents like lignocaine on impacting long~     term survival.~      Methodology / Treatment plan~      The study drug (0.5% lidocaine 60mM) will be tested in the intraoperative setting prior to~     surgery will be tested in a randomized setting.:~      Arm A: 60mM of 0.5% lignocaine will be injected peritumoral prior to excision. The local~     anesthetic should be injected on all 6 surfaces of the tumor and also within the tumor. Wait~     for 7 minutes for its action followed by surgery. (Intervention arm) Arm B: No injection of~     lignocaine prior to excision (Control arm)~   "
126149|NCT01916304|"~     The purpose of this study is to investigate the effect of switching participants taking~     levothyroxine to a new sodium formulation.~   "
126150|NCT01916291|"~     Dinoprostone(propess) is commonly used for induction of labor in the pregnant women who has~     intact membrane after 38weeks of gestational age. The investigators study safety and efficacy~     of dinoprostone in the pregnant women with premature rupture of membrane or GA<38weeks~   "
126151|NCT01916278|"~     A 12-month, randomised, evaluator-blinded, comparative, multicentre study of the safety and~     efficacy of lip injections with Emervel Lips Lidocaine and Juvéderm Volbella with Lidocaine.~   "
126152|NCT01916265|"~     The ultimate goal of the PCDIAB project is to develop a bi-hormonal pump (insulin and~     glucagon) substituting for the pancreas and facilitating tight euglycemic control in patients~     with T1DM.~   "
126153|NCT01916252|"~     This protocol is a national, multicenter, comparative, open-label, randomized trial comparing~     the progression free survival (PFS) of two pre-transplant conditioning regimens (BUMEL~     versus. MEL-200).~      A total of 460 patients will be enrolled in the study. Scheduled evaluations and study visits~     will take place during the pre-treatment, treatment and follow-up periods.~      The pre-treatment period includes the screening visit in which participants provide informed~     consent in writing in order to take part in the study. The patient is then assessed to~     determine his/her eligibility. The selection process will begin 21 days before the first dose~     of medication is administered (days -21 to 0). During the treatment period, eligible patients~     will be included in the study and given six cycles of induction treatment with bortezomib/~     lenalidomide / dexamethasone (VRD-GEM). Each cycle will last 28 days, during which SC~     bortezomib will be administered on days 1, 4, 8 and 11, oral lenalidomide on days 1-21 of~     each cycle, and oral dexamethasone on days 1-4 and 9-12 of the cycle.~      After the first three induction cycles, and in the absence of progression or unacceptable~     toxicity, peripheral blood hematopoietic stem cells will be mobilized and collected using~     G-CSF for later autologous transplantation. Patients will be randomized in a 1:1 allocation~     ratio to receive conditioning treatment with MEL-200 versus BUMEL. Randomization will take~     place at the beginning of the study, once the screening is complete and the patient's~     eligibility verified. Three months after transplantation, patients will receive two cycles of~     consolidation treatment with VRD-GEM at the same doses administered during induction~     treatment.~      Once the treatment phase is complete, patients will begin the follow-up phase in which they~     will be visited every three months to evaluate disease progression and survival~   "
126154|NCT01916239|"~     The most relevant pomegranate phenolics (ellagitannins and ellagic acid) are extensively~     metabolized by the human gut microbiota to yield a number of metabolites called urolithins~     (mainly Uro-A). Urolithins have been reported to regulate in vivo the expression of genes~     involved in inflammation and cancer. Our hypothesis is that urolithins can be detected in the~     human colon mucosa where these metabolites can exert anti-inflammatory and anti-cancer~     activities. After colonoscopy and diagnosis, colorectal cancer patients will consume capsules~     containing three different pomegranate extract formulations until surgery. The aims of this~     trial are:~        -  To evaluate the disposition of pomegranate phenolics and urolithins in tumoral and~          normal colon tissues.~        -  To evaluate gene expression profiling and protein markers in tumoral and normal colon~          tissues from these patients.~        -  To compare different pomegranate extract formulations on the above.~   "
126155|NCT01916226|"~     This phase IV investigational trial is being conducted to evaluate the efficacy of a 2-week~     treatment of fluticasone propionate nasal spray (FPNS) vs. cetirizine on allergic nasal and~     ocular symptoms and quality of life in adult subjects with SAR. It is hypothesized that FPNS~     provides greater nasal symptom relief than cetirizine. The primary measure used to test this~     hypothesis is the change from baseline over two weeks in reflective total nasal symptom score~     (rTNSS) compared between FPNS and cetirizine. Approximately 648 subjects will be randomized~     into a 1:1:1:1 ratio of treatment allocation across approximately twenty-five to thirty-five~     sites in the US during the 2013 fall allergy season. All subjects will be outpatients. The~     total duration of study will be approximately 21 days including 7 days of screening period,~     and 14 days of treatment period.~   "
126156|NCT01916213|"~     The investigators would like to assess whether selecting mature sperm using PICSI (selecting~     for sperm that bind hyaluronan) can optimize the IVF outcome of ICSI .~      Aim~        1. Primary outcome: To compare routine sperm selection using ICSI with sperm selection~          using PICSI plates in terms of implantation and fertilization rates for couples with~          male factor fertility~        2. Secondary outcome : To compare live birth rates ,ongoing pregnancies and miscarriage~          rates for couples with male factor infertility using routine sperm selection with ICSI~          compared to using PICSI plates for sperm selection~      Hypothesis:~      Sperm selected for ICSI using (PICSI) will reveal increased implantation rates in comparison~     to sperm selected for conventional ICSI~   "
126158|NCT01916187|"~     The purpose of this study is to determine the best dose of imetelstat when given alone for~     patients with neuroblastoma and also when given in combination with 13-cis-retinoic acid.~   "
126159|NCT01916174|"~     This trial is conducted in Europe. The aim of this trial is to assess the expected biological~     equivalence between two formulations of insulin degludec/liraglutide (IDegLira) with~     identical active ingredient in healthy volunteers.~   "
126235|NCT01915173|"~     The purpose of this study is to investigate the effects of a widely available over the~     counter supplement marketed for heartburn symptoms on symptoms and health-related quality of~     life in patients with gastroesophageal reflux disease (GERD). This study is designed as a~     pilot trial to assess safety and feasibility and to provide preliminary estimates of effect~     sizes.~   "
126160|NCT01916161|"~     Inflammatory Bowel Diseases (IBD) are life-long, incurable illnesses that can have a profound~     effect on the patients quality of life. Disease education is a corner stone of IBD care to~     enable patients to take up an active role in their disease management. While patient~     education is enshrined in the IBD standards, actual patient knowledge is often poor.3~     Knowledge is not associated with the level of the patient's educational achievement, but~     member of patient organisations such as Crohn's and Colitis UK (CCUK) have significantly~     better knowledge than non-members. This may highlight the positive effects of education~     offered by CCUK, but it is also conceivable that patients with a greater interest in their~     disease are more like to join organisations like CCUK. Different sources of patient~     information may therefore influence what level of disease related knowledge a patient~     achieves.~      Apart from high quality clinical information provided by professional organisation (British~     Society of Gastroenterology, European Crohn's and Colitis Organisation), the National Health~     Service and charities (CORE, CCUK), there is also a host of unregulated information~     available. The emerging dominance of the internet for information gathering has provided easy~     access for patients to a host of websites providing information on IBD. A number of these~     provide alternative (not evidence based) views, which could have a potentially negative~     impact on patient's knowledge. Furthermore patients often share their stories on internet~     forums and it is likely that those stories share are more likely to represent the extreme~     ends of disease rather than those experienced by the majority. This could potentially cause~     anxiety in patients with IBD. The quality of information found on the internet varies widely~     and up to 50% of websites have been judged as poor. The vast majority of patients with IBD~     have access to the internet and more than half use to search for health related information.7~     We have previously also demonstrated that patients with anxiety have better disease related~     knowledge of IBD.~   "
126161|NCT01916148|"~     This purpose of this study is to determine the ability of an~     18F-fluoro-L-dihydroxyphenylalanine (18F-DOPA) PET scan to detect a focal lesion of~     hyperinsulinism and determine the location in patients with congenital hyperinsulinism,~     Beckwith Wiedemann Syndrome and suspected insulinoma. Safety data will be collected.~   "
126162|NCT01916135|"~     This study is the first time that a new experimental drug called [18F]-SKI-249380 is being~     used in people. [18F]-SKI-249380 is not a therapeutic drug. [18F]-SKI-249380 is a drug that~     will be used with PET scanners to 'see' where [18F]-SKI-249380 goes in the body, after its~     injected. The researchers believe that scans with [18F]-SKI-249380 might be able to find~     tumors in patients.~      This study is being done to see how long [18F]-SKI-249380 stays in the blood, when it is~     given to people in tiny amounts by an injection into a vein in their arm, and to see where~     [18F]-SKI-249380 goes in the body. If the results of this trial are good, then the study~     doctors plan to use [18F]-SKI-249380 in another trial to see if scans with [18F]-SKI-249380~     are better for finding tumors compared to the standard types of scans that doctors use.~   "
126163|NCT01916122|"~     These are tumors which expresses estrogen receptors. Estrogen receptors are found within~     breast cancer cells and are an important marker of which medicines may best treat a breast~     cancer. This study is being performed to imaging the amount of estrogen receptors expressed~     in the tumor. A research agent named 16α-18F-fluoroestradiol (FES) finds estrogen receptors~     and binds to them. Then tumors with estrogen receptors can be imaged by a PET/CT scanner, a~     machine that can take pictures of where the FES is and how much FES is present. The results~     of this study may help researchers know whether FES can be used to monitor changes in~     estrogen receptors in tumors during treatment.~   "
126164|NCT01916109|"~     The purpose of this study is to find out if using the combination of standard chemotherapy~     (gemcitabine and carboplatin) plus this new drug (panitumumab) can help to shrink the tumor~     before the patient undergoes surgery for bladder cancer.~   "
126165|NCT01916096|"~     The primary objective of the study examines the success rate of various OneTouch Delica~     lancet sizes across depth settings of the OneTouch Delica lancing device. The sample size is~     based on 30 subjects per lancet size for a given depth setting. Each subject is lanced 4~     times with two lancet sizes at a single depth setting. There will be 120 paired lancing~     events for each lancet size within the group.~      Null hypothesis (H0): there is a 90% success rate of attaining a minimum blood volume of~     1.0μL for the 28g lancet across all depth settings.~      Alternate hypothesis (H1): the success rate of attaining a minimum blood volume of 1.0μL for~     the 28g lancet across all depth settings is less than 90%.~   "
126166|NCT01916070|"~     Patients with the symptom complex syncope or near-syncope are quite often in the emergency~     department. Most patients with syncope have a positive prognosis. However some types of~     syncope are associated with an increased morbidity and mortality. It is a challenge to detect~     these patients reliably at an early stage. The current guidelines contain exact definitions~     concerning the characteristics of patients with syncope and recommendations on how to~     diagnose and treat these patients following standardized pathways. Due to the fact that~     near-syncope is poorly defined and therefore seldom evaluated in clinical trials, data~     concerning near-syncope are rare.~      Our aim was to characterize patients presenting with syncope or near-syncope to the emergency~     department regarding their risk profile, comorbidities and prognosis. First we evaluated if~     there is a difference between the two groups syncope and near-syncope concerning type and~     frequency of adverse events. Furthermore we analyzed the routinely measured cardiac~     biomarkers NT-proBNP and hs cTnT in patients with syncope or near-syncope. Then we determined~     both their prognostic accuracy in predicting adverse events and their diagnostic accuracy in~     finding the underlying etiology. Finally we analyzed a special patient collective, patients~     aged ≥ 65 years. It is assumed that elderly patients are suffering from comorbidities and~     age-related physiological and cognitive disabilities. We therefore hypothesize that elderly~     patients, in contrast to patients aged < 60, display an increased risk of adverse events and~     that they have a poorer prognosis.~   "
126167|NCT01916057|"~     The purpose of this study is to determine whether F18 fluorodeoxyglucose (18F-FDG)~     positron-emission tomography scan (PET scan) is useful for the therapy strategy of~     hepatosplenic candidiasis.~   "
126175|NCT01915953|"~     The purpose of the study is to define the precision, accuracy and variability of the NBM-200~     system in non invasive blood Hemoglobin (Hb) measurements relative to the laboratory blood~     analyzer by comparing two consecutive Hb values obtained by the NBM system to venous values.~   "
126176|NCT01915940|"~     The objective of this Phase 2 study is to evaluate whether the Bimatoprost Ocular Insert is~     non-inferior to that of timolol ophthalmic solution (0.5%) at 12 weeks.~   "
126271|NCT01914705|"~     The objective of the study is to investigate whether or not there will be a significant~     difference between landmark vs. ultrasound guided approach during Subclavian Central Venous~     Catheter (SCVC) placement in terms of the success rate, the time it takes to perform the~     procedure and the complication rate. By using ultrasound to identify anatomical structures~     that are not seen during the landmark approach, the investigators hypothesize that both the~     procedural time and the complication rate of ultrasound guided approach should be lower than~     the landmark approach. The investigators hypothesize that the success rate will be higher in~     the ultrasound group.~   "
126168|NCT01916044|"~     The rate of caesarians dramatically increased for 15 years. The main indication of caesarian~     became the iterative caesarian of principle because of a history of caesarian. Any attempt of~     reduction of the rate of caesarians should thus focus on the indications of iterative~     principal caesarean. Nevertheless, the main reason usually evoked to justify a reduction of~     the attempts of low way after caesarian is the concern generated by the risk of uterine break~     during the trial of labor. Yet, there is no reliable method to predict this risk of uterine~     break. A way of interesting research consists in estimating the potential profits of the~     echography of the scar lower segment. Indeed, the echography can be useful to determine the~     specific risk of uterine break of a patient by measuring the thickness of the lower segment~     of the womb.~      The strong negative predictive value of the echography of the lower segment on the risk of~     uterine break should encourage the women encircled to accept a trial of labor. That is why,~     this examination associated with a rule of decision could help to decrease the rate of~     iterative elective caesarians and especially to decrease the mortality and the foetal and~     maternal morbidity connected to the trial of labor among the patients having a history of~     caesarian.~   "
126169|NCT01916031|"~     The purpose of this study is to comparatively assess the effectiveness of a tailored~     educational intervention to improve health literacy levels regarding upper respiratory~     infections (URIs) and to decrease pediatric emergency department (PED) visits, among Latino~     households in Early Head Start.~   "
126170|NCT01916018|"~     Congenital hypothyroidism (CH) is a rare disease that affects 1 in 3500 newborn. This~     condition is detected consistently since the late 1970s in France, which has led to early~     care and a significant improvement in prognosis and intellectual stature of these children.~     However neurodevelopmental disorders persist in 10-15% of cases. More associated diseases~     have been reported in approximately 10% of cases. These observations are in most cases poorly~     understood. The family nature of the CH is now well recognized and a dozen genes involved up~     to now. However, in the majority of cases (HC not due to a disorder of the organification of~     iodine), few mutations have been found in the reported number of patients (5-10%), suggesting~     the involvement of other genes. Some of the genes have been implicated in particular specific~     syndromic forms but many pathological associations remain unexplained. Also, a more complete~     genetic elucidation of CH would enable a better understanding of its etiology and thus its~     risk of familial recurrence (frequently asked questions by parents of children with CH) and~     secondly the presence of associated pathologies.~      Main goal: to describe the population with CH (not due to a disorder of the organification of~     iodine) not only on clinical, biological and radiological (phenotypic analysis) but also on~     the genetic level to establish a genotype / phenotype correlation.~   "
126171|NCT01916005|"~     The diagnosis of prosthetic valve endocarditis (PVE) remains challenging. In PVE cases,~     initial echocardiography is normal or inconclusive in almost 30% of cases, leading to a~     decreased diagnostic accuracy for the modified Duke criteria.~      Aims: The investigators sought to determine the value of 18F-fluorodeoxyglucose positron~     emission tomography/computed tomography (18F-FDG PET/CT) for diagnosing PVE.~      Methods: In two referral French centers (Timone Hospial, Marseille and Georges Pompidou~     European Hospital, Paris), the investigators plan to include consecutive patients suspected~     of having PVE. All of the patients will be subjected to clinical, microbiological, and~     echocardiographic evaluation. Cardiac PET/CT will be performed at admission and the data~     analysis will be based on visual interpretation and quantitative measurement of FDG uptake~     (SUVmax). The final diagnosis will be defined according to the clinical and/or pathological~     modified Duke criteria determined during a 3-month follow-up (gold standard).~   "
126172|NCT01915992|"~     The NK cells participate in the innate immunity against infectious agents or transformed~     cells that are recognized as no self by the absent, weak or abnormal expression of human~     leukocyte antigen (HLA) class I molecules. According to the missing self hypothesis, a~     negative signal is delivered to NK cells when their inhibitory receptors are engaged by the~     specific HLA class I molecules. NK activation requires a positive signal delivered by the~     engagement of activating receptors, more particularly of the Natural cytotoxicity receptors~     or NCRs who are directly involved in the natural cytotoxicity of Natural Killer. The~     activating receptors include NKp46, NKp44 and NKp30, also called NCR 1, 2 and 3 respectively.~     NKp46 and NKp30 are constitutively expressed on the surface of the NK, the expression of~     NKp44 is observed only after activation of cells NK. NK cells from most (80%) healthy donors~     express a high quantity of NCR on their surface, corresponding to the NCRbright phenotype~     while only 20 % present the NCRdull phenotype. In sharp contrast, most patients (80%) having~     leukaemia have the NCRdull while only 20 % patients have the NCRbright phenotype. The culture~     of NK from healthy donors ( NCRbright) with leukaemic cells result in decreased expression of~     the NKp30 while there is no difference on expression if these same NK are cultivated with~     cells from healthy donors. Moreover, study of AML patients showed that the NCRdull phenotype~     was acquired during leukemia development because it was observed its complete (for NKp46) or~     partial (for NKp30) reversibility in patients achieving complete remission (CR).~     Reversibility of the NCRdull phenotype after CR suggested that leukemia cells might be~     involved in NCR down-regulation. In line with these observations, we aim to study the~     mechanism of NCR down-regulation by cultivating NK NCRbright from healthy donors with~     leukaemic cells or healthy haematopoietic cells, in order to observe the appearance of the~     NCRdull phenotype and verify by qPCR if this down-regulation is transcriptionnal. If this~     hypothesis is be verified, we will study the regulation of NCR by focusing on the implication~     of genes NCR transcription factors via bio-informatic analysis of putative transcription~     factors fixation sequences in the promoters of these genes, followed by the verification of~     the capacity of identified sequences to bind transcription factors. Ultimately, we will~     verify the real implications of these transcription factors by studying the effect of their~     silencing by RNA interference experiments.~   "
126173|NCT01915979|"~     The overall objective of the study is to assess the effectiveness of the treatment of~     degenerative rotator cuff tendinopathy using the application of plasma rich in growth factors~     (PRGF).~      Main objective:~      To show more effectiveness after 6 months of treatment with PRGF, with an improvement in the~     reference test of more than 15% compared to the treatment with corticosteroids.~      Secondary objective:~        -  To assess the efficacy of the treatment after 12 months.~        -  Quantification of platelet levels in patients treated with plasma rich in growth factors~          and its correlation with the clinical effect.~   "
126174|NCT01915966|"~     Xerostomia or dry mouth is the subjective feeling that there is not enough saliva in your~     mouth. It's a frequent symptom in terminally ill patients receiving palliative care, reducing~     their quality of life and comfort. Usual recommendations in these patients are good oral~     hygiene and mouthwashes, ad libitum consumption of camomile and lemon juice infusions, and ad~     libitum sucking of cold (e.g. ice, ice cream) or citric products (e.g. pineapple). Other~     xerostomia treatments such as artificial saliva and pharmacological drugs (e.g. pilocarpine)~     are less used in terminally ill patients due to cost and secondary effects.~      The purpose of this randomized parallel clinical trial is to determine if a new recipe of~     gelatin with orange juice, cardamome and ginger is more effective in the control of~     xerostomia than the usual treatment of camomile infusion with lemon juice against. Treatments~     will be consumed ad libitum during one week. The main outcome is the subjective assessment of~     dry mouth at end of treatment.~   "
126177|NCT01915927|"~     The investigators propose to study the safety of autologous mesenchymal stromal cell transfer~     using a biomatrix (the Gore® Bio-A®; Fistula Plug) in a Phase I study using a single dose of~     20 million cells. Twenty adult patients (age 18 years or older) with refractory, complicated~     perianal fistulizing Crohn's disease will be enrolled. Subjects will undergo standard~     adjuvant therapy including drainage of infection and placement of a draining seton with~     continuation of pre-existing anti-Crohn's therapy. Six weeks post placement of the draining~     seton, the seton will be replaced with the MSC loaded Gore® Bio-A® fistula plug as per~     current clinical practice. The subjects will be subsequently followed for fistula response~     and closure for 24 months. This is an autologous product derived from the patient and used~     only for the same patient.~   "
126178|NCT01915914|"~     This is an open-label, randomized, comparative study, including 4 phases: SCREENING, ACUTE,~     MAINTENANCE and FOLLOW-UP.~      Subjects will complete the SCREENING phase to check the eligibility within 7 days after they~     sign the written informed consent form. All eligible subjects will be enrolled in ACUTE phase~     to receive twice daily Fluticasone propionate (FP) 0.05% cream up to 4 weeks. The efficacy~     and safety in ACUTE phase will be assessed every 2 weeks up to 4 weeks or until Treatment~     Success which depends on which time point comes first. Then subject can get into the~     MAINTENANCE phase receiving either emollient twice daily plus FP 0.05% cream once daily twice~     a week (Group A), or emollient twice daily (Group B), by 1:1 randomization. The treatment~     duration in MAINTENANCE phase will be up to 20 weeks. The efficacy and safety in MAINTENANCE~     phase will be assessed every 4 weeks up to 20 weeks or until AD relapse that depends on which~     time point comes first. If subjects don't experience relapse during MAINTENANCE phase,~     subsequent FOLLOW-UP phase applying emollient twice daily won't be longer than another 12~     weeks.~      Total study duration is up to 37 weeks. All subjects receive FP 0.05% cream twice daily up to~     4 weeks to all affected sites and any newly occurring sites in ACUTE phase. After~     randomization in MAINTENANCE phase, subjects either receive emollient twice daily extendedly~     plus FP 0.05% cream once daily twice a week to all healed sites and any newly occurring sites~     (Group A), or emollient twice daily extendedly (Group B), up to 20 weeks. In FOLLOW-UP phase,~     all subjects apply emollient twice daily up to 12 weeks.~      This study will enrol 120 subjects, and propose at least 80 subjects to be randomized.~      Study Endpoints/Assessments:~      Primary endpoint is to observe the median time to the first relapse of AD during MAINTENANCE~     phase.~      Secondary endpoints are:~        1. Median time to the first relapse of AD during the whole study (including maintenance~          phase and follow-up phase.~        2. Numbers of recurrent patients at the end of MAINTENANCE phase;~        3. Numbers of recurrent patients at the end of FOLLOW-UP phase;~        4. The effective rates (proportion of treatment success patients) during ACUTE phase (V3,~          W-2±2days;V4, W0±2days )~        5. Evaluate the safety during the whole study duration (ACUTE phase, MAINTENANCE phase,~          FOLLOW-UP phase respectively);~        6. Evaluate visual skin assessment for signs of cutaneous atrophy, epidermal thickening /~          lichenification and abnormal pigmentation changes during the whole study duration (ACUTE~          phase, MAINTENANCE phase, FOLLOW-UP phase respectively);~        7. The change of Quality of Life (QoL) from baseline at the end of MAINTENANCE phase;~        8. The change of Quality of Life (QoL) from baseline at the end of FOLLOW-UP phase;~        9. Subjects' post-study evaluation to drugs.~   "
126179|NCT01915901|"~     The primary objective of the study is to determine the effect of bismuth subsalicylate~     (Pepto-Bismol®) 524 mg versus placebo on gastrointestinal (GI)-related events reported in~     healthy volunteers receiving TECFIDERA™ (dimethyl fumarate [DMF]; also known as BG00012)~     twice daily (BID) The secondary objectives of this study in this study population are: To~     characterize the effect of bismuth subsalicylate (Pepto-Bismol®) 524 mg versus placebo on the~     frequency, severity, and duration of GI-related events and to evaluate GI-related events that~     lead to discontinuation of DMF.~   "
126180|NCT01915888|"~     This study aims to estimate the clinical and cost impact of Rotarix vaccinations among~     children aged less than 5 years using insurance claims data from commercial plans and~     Medicaid low-income population. The impact of incomplete and complete Rotarix vaccination~     will also be examined, overall and stratified by calendar time of Rotarix vaccination (e.g.,~     2008 onward).~   "
126181|NCT01915875|"~     The purpose of this study is to evaluate the impact of the global approach to the pain in~     cystic fibrosis patients with chronic or intermittent pain. The patients will receive in~     addition to an usual pharmacological and psychological management, sophrology sessions at~     home. The results of this study will provide a new strategy of management of the patient's~     pain.~   "
126182|NCT01915862|"~     The purpose of this study is the evaluation and comparison of blood pressure variability~     indices and ambulatory arterial stiffness index obtained by ambulatory blood pressure~     monitoring as prognostic indicators in the functional outcome of acute ischemic stroke.~   "
126183|NCT01915849|"~     The purpose of the study was to assess the effect of LIK066 on intestinal glucose absorption~     immediately after a single dose (immediate effect) and 6 hours following the dose (after~     multiple daily doses; sustained effect) in patients with type 2 diabetes mellitus (T2DM).~   "
126184|NCT01915836|"~     The purpose of this study is to test a web-based video game to help cancer patients quit~     smoking. The investigators are interested in what participants like and do not like about the~     game.~   "
126185|NCT01915823|"~     The purpose of this study is to determine if Dymista nasal spray is better and safer than~     placebo in treating children ages 4 to <12 years old who have seasonal allergic rhinitis.~   "
126186|NCT01915810|"~     The goal of this research study is to better understand if taking part in physical activity~     might help smokers quit.~   "
126187|NCT01915797|"~     The overall project goal is to build a database of childhood cancers associated with~     developmental anomalies; it aims at identifying new syndromes of genetic predisposition and~     at enabling the further study of their molecular basis.~   "
126188|NCT01915784|"~     Preference study: Genuair® (Pressair™) vs Breezhaler® (Neohaler™) inhalers in patients with~     COPD~   "
126189|NCT01915771|"~     Objectives:~      To evaluate the intra-subject variability of the pharmacokinetics (PK) of single oral capsule~     doses of 20 mg lomitapide.~   "
126190|NCT01915758|"~     This was a single-center, evaluator-blinded, randomized, placebo (vehicle) -controlled phase~     I study to evaluate the photoallergic potential of Clindamycin-Tretinoin Gel. The design~     consisted of the following periods: screening, induction, rest, challenge, and rechallenge~     (if indicated). Induction visit 1 was to occur within 5 days of screening visit 2. The study~     expected to enroll approximately 62 healthy adult volunteers. Subjects were to receive~     repeated 24-hour study patch applications; after patch removal, the sites were irradiated~     with ultraviolet B light (UVB) and visible light (VIS) during the induction period~     (consisting of 6 consecutive induction phases), and ultraviolet A light (UVA)/ UVB and VIS~     during the challenge and rechallenge periods. Each application site was observed~     approximately 1, 24, 48, and 72 hours later for signs of inflammation.~   "
126191|NCT01915745|"~     The purpose of the study is to show that the standardized sending of SMS improve the bone~     mineral density (BMD) screening of patients seen in the Emergency department for low trauma~     fracture.~   "
126211|NCT01915485|"~     Medullary thyroid cancer is a neuroendocrine tumour. As so, it has somatostatin receptors in~     its membrane. Furthermore, very little is available to treat patients who have disease~     progression. The investigators hypothesized that those tumors may respond to 177-Lu-DOTA~     Tyr3-octreotate which is a ligand to somatostatin receptors.~   "
126272|NCT01914692|"~     Gastric cancer radical surgery related complications are common.Somatostatin is a~     conventional medical therapy for bleeding.This study explore the effect of Somatostatin for~     Advanced Gastric Cancer After D2 Lymph Node dissection.~   "
126192|NCT01915732|"~     This is a multicentre, randomized, assessor-blind, comparator-controlled evaluation of the~     efficacy, safety, and tolerability of Duac™Once Daily Gel and clindamycin phosphate gel in~     the topical treatment of mild to moderate facial acne vulgaris. A total of 1020 subjects will~     be enrolled, 510 per study arm. The subjects will be males and females between 12 and 45~     years of age, inclusive, at the time of consent, who have mild to moderate facial acne~     vulgaris.~      Subjects will use Duac™Once Daily Gel (once daily in the evening) or clindamycin phosphate~     gel twice daily (once in the morning and once in the evening) for 12 weeks. The subjects will~     be evaluated for change in lesion counts, investigator's static global assessment (ISGA),~     subject's global assessment (SGA), local tolerability and AEs/SAEs at Weeks0, 1, 2, 4, 8, and~     12 (or at early withdrawal). In addition, quality of life measures will be performed at every~     study visit.~   "
126193|NCT01915719|"~     Assess the superiority of early non invasive ventilation in comparison to Oxygen therapy~     only, for immuno-compromized patients with acute respiratory failure~   "
126194|NCT01915706|"~     The purpose of this study is to compare the post-operative complication rates and surgical~     outcomes in patients with a Baerveldt 350 implant following scheduled rip-cord removal in~     clinic at post-operative week 3 versus spontaneous tube opening. Patients age 18 or greater~     with uncontrolled glaucoma and scheduled to undergo their first superotemporal Baerveldt 350~     implant will be recruited and randomized at the time of enrollment to either scheduled~     ripcord removal at post-operative week 3 or no ripcord removal. Incidence of complications~     will be documented and compared between the 2 groups. The final intraocular pressure control~     between the 2 groups will also be compared in a secondary outcome analysis. This study will~     help to establish post-operative management guidelines to minimize complications and improve~     intraocular pressure lowering success following Baerveldt 350 implantation.~   "
126195|NCT01915693|"~     The single most distressing symptom for more than 70% of patients with oesophageal cancer is~     difficulty in swallowing (dysphagia) caused by blockage of the gullet by a tumour. This~     causes severe restrictions on food intake, physical activity, social functioning and overall~     quality of life. Amongst the more effective treatments for improving swallowing, is the~     insertion of a metal stent across the blocked part, which then self-expands to open up the~     gullet (Self Expanding Metal Stent or SEMS). The addition of radiotherapy may help to improve~     the problems caused by dysphagia and provide an additional survival benefit.~      The purpose of this study is to test the impact of adding radiotherapy to SEMS on:~        -  the length of time swallow remains improved for~        -  quality of life~        -  survival~   "
126196|NCT01915680|"~     The purpose of the study is to investigate the IOP difference between normal and glaucomatous~     eyes using standard ophthalmic tonometry devices while subjects are performing different~     standard yoga asanas. The IOP of participants will be measured prior, immediately at start of~     the asana, 2 minutes into the asana, and immediately after assuming a sitting position. The~     patient will wait 10 minutes and a final IOP will be taken. Four standard yoga asanas will be~     tested.~   "
126197|NCT01915667|"~     The purpose of the study is to evaluate the amount of compound present in the blood (relative~     bioavailability) after a single administration of GLPG0634 as a tablet versus a capsule in~     fasted conditions in male healthy subjects.~      Also, the effect of food on the bioavailability of the tablet formulation will be studied as~     well as the safety and tolerability of single oral doses of GLPG0634 given either as capsule~     or tablet.~   "
126198|NCT01915654|"~     The purpose of the transfusion of packed red blood cell is to overcome acute or chronic~     anemia cause tissue hypoxia. It increases hemoglobin concentration and consequently increase~     oxygen delivery to peripheral tissues. The perioperative period of major surgery is a field~     particularly favorable to the development of tissue hypoxia, which is associated with~     increased mortality and postoperative morbidity. Optimization of oxygen transport to tissues~     at the preoperative period is accompanied by a significant reduction of these major~     complications.~      Clinical complications (infectious or otherwise) related to transfusion of caps Red Blood~     cells Caps (RBC)are well known. Many studies seem to evidence the potentially deleterious~     effect of transfusion, especially in patients with poor condition, related to storage time.~     Indeed, during storage, impaired blood-related storage is created. It is metabolic,~     biochemical and molecular levels. Many studies, carried out in particular in cardiac surgery~     where patients are suitable for transfusion RBC, have focused on the effect of transfusions~     on consumption and the transport of oxygen to demonstrate the impact of conservation lesions~     on their role in vivo. In particular, a single-center retrospective American study showed~     reduction of postoperative complications in patients who received RBC under 14 days.~      However one of the confounding factors present is that all transfused RBCs are not~     leukoreduced (unlike the French transfusion policy). In addition, the greater part of the~     clinical studies are controversial. That is why we aim to assess, through a retrospective~     study of data, the impact of transfusion of red red blood cells within 14 days of~     post-operative morbidity and mortality, compared to the usual transfusion practice in cardiac~     surgery patients.~   "
126199|NCT01915641|"~     We have reported that CPAP treatment improved the walking capacity of overlap syndrome~     patients.~      However, the previous study was not randomized, double blinded study. Therefore, we design a~     prospective, randomized, double blinded, controlled, cross-over trial to confirm this~     finding.~   "
126200|NCT01915628|"~     Prospective, multi-center registry to be conducted at 6 Canadian interventional cardiology~     centers. The e-BioMatrix data will be compared with a historical control group, the Cypher~     arm of the Biosensors Leaders study consisting of 313 patients. All patients will be followed~     for up to 2 years.~   "
126212|NCT01915472|"~     This is a Phase II trial to study the safety and efficacy of IMMU-130. IMMU-130 is composed~     of a drug attached to an antibody. The drug is the active ingredient in irinotecan which is a~     common chemotherapy drug used for colorectal cancer. Antibodies are proteins normally made by~     the immune system. They bind to substances that don't belong in the body to prevent harm to~     the body. The antibody in this study was designed to bind to a marker located on colorectal~     cancer tumors. The antibody was originally made from mouse proteins, but was changed in the~     laboratory to be more like human antibodies. This study will investigate how IMMU-130 acts~     for the treatment of colorectal cancer. The study is mainly being done to see if IMMU-130 is~     safe and effective.~   "
126213|NCT01915459|"~     The purpose of this study is to evaluate the safety and efficacy of Botulax® compared to~     Botox® reducing upper limb muscle tone in post stroke patients.~   "
126201|NCT01915615|"~     Hypertrophic cardiomyopathy (HCM) is the most common monogenic heart disease and the most~     frequent cause of sudden cardiac death (SCD) in the young. It is characterized by unexplained~     left ventricular hypertrophy (LVH), diffuse and patchy fibrosis, and myofibrillar disarray.~     While the majority of patients remain asymptomatic, prognosis is poor in a subset who present~     with SCD or progress to heart failure (HF). Current methods to predict risk of these adverse~     events and to target therapy are limited. Current medical therapy does not protect against~     SCD, nor does it prevent development of HF. Therefore, the identification of novel risk~     markers would help develop therapeutic targets aimed at altering the phenotypic expression to~     impact the natural history, especially SCD and HF. Cardiovascular magnetic resonance (CMR) is~     emerging as a powerful tool for diagnosis and risk stratification in HCM including assessment~     of LV mass and pattern of hypertrophy. Late gadolinium enhancement by CMR is a marker of~     focal myocardial fibrosis which is thought to underlie the arrhythmogenic substrate as well~     as promote development of HF. The investigators hypothesize that HCM patients with a higher~     primary outcome event rate can be identified by novel CMR findings. The majority of cases of~     HCM are autosomal dominant and about 60% are caused by mutations in genes encoding cardiac~     sarcomeric proteins. However, the relationship between genetic mutation, disease phenotype,~     and clinical outcomes remains poorly understood. The investigators hypothesize that HCM~     patients with sarcomeric HCM mutations will have a higher primary outcome event rate and more~     marked myocardial pathology on CMR than those without. Furthermore, there may be a link~     between sarcomeric mutations and fibrosis, as mutation carriers with overt HCM as well as~     those without hypertrophy have elevated markers of collagen turnover. The investigators~     therefore hypothesize that serum biomarkers of collagen metabolism in HCM will predict~     outcomes. Thus, the Specific Aim is to develop a predictive model of cardiovascular outcomes~     in HCM by: 1) using exploratory data mining methods to identify demographic, clinical, and~     novel CMR, genetic and biomarker variables associated with the outcomes and 2) develop a~     score from the predictive model that can be used to assess risk given a patient's combination~     of risk factors, thus establishing the evidence base to enable clinical trial design to~     reduce morbidity and mortality in HCM in a cost-effective manner.~   "
126202|NCT01915602|"~     This is a study to investigate the potential clinical benefit of refametinib when given in~     combination with sorafenib as first line treatment in patients with unresectable or~     metastatic HCC carrying a RAS mutation. The study will be conducted in 2 stages.~     Approximately 95 patients (15 at Stage 1/ 80 at Stage 2) will be accrued to this study to~     receive treatment. Stage 2 of the trial will only be conducted if at least 5 out of 15~     patients at Stage 1 show at least partial response according to an objective criteria to~     evaluate tumor size based on contrast enhancement [modified response evaluation criteria in~     solid tumors (mRECIST)] assessed by external independent radiologists.~      Refametenib is an oral (i.e. taken by mouth) protein kinase inhibitor. A kinase inhibitor~     targets certain key proteins that are essential for the survival of the cancer cell. By~     specifically targeting these proteins, refametinib in combination with sorafenib may stop~     cancer growth. The growth of the tumor may be decreased by preventing these specific proteins~     from functioning.~      The primary endpoint (the most meaningful result to be tracked) of this study is based on the~     rate of response, i.e. the disease getting smaller. The aim is to show that the therapy with~     refametinib in combination with sorafenib improves the response rate in this patient~     population compared to historical results observed with the sorafenib only.~   "
126203|NCT01915589|"~     This is a study to investigate the potential clinical benefit of refametinib in patients with~     unresectable or metastatic HCC carrying a RAS mutation. The study will be conducted in 2~     stages. Approximately 95 patients (15 at Stage 1/ 80 at Stage 2) will be accrued to this~     study to receive treatment. Stage 2 of the trial will only be conducted if at least 5 out of~     15 patients at Stage 1 show at least confirmed partial response (PR) according to modified~     response evaluation criteria in solid tumors (mRECIST) assessed by central image review.~      Refametinib is an oral (i.e. taken by mouth) protein kinase inhibitor. A kinase inhibitor~     targets certain key proteins that are essential for the survival of the cancer cell. By~     specifically targeting these proteins, refametinib may stop cancer growth. The growth of the~     tumor may be decreased by preventing these specific proteins from functioning.~      The primary endpoint (the most meaningful result to be tracked) of this study is based on the~     rate of response, i.e. the disease getting smaller. The aim is to show that the therapy with~     refametinib improves the response rate in this RAS mutation patient population.~   "
126204|NCT01915576|"~     This is the first study where BAY1125976 is given to humans. Patients (all comers) will~     receive the study drug treatment in a dose-escalation scheme (no placebo group) to determine~     the safety, tolerability and maximum tolerated dose (MTD) of BAY1125976. The relative~     bioavailability of liquid service formulation and tablets will be determined.~      After the MTD is defined breast cancer patients with and without AKT1 mutation will be~     treated.~      The study will also assess the pharmacokinetics, biomarker status, pharmacodynamic parameters~     and tumor response of BAY1125976.~      BAY1125976 will be given daily as single oral application. Treatment will be stopped if the~     tumor continues to grow, if side effects, which the patient cannot tolerate, occur or if the~     patient decides to exit treatment.~   "
126205|NCT01915563|"~     To evaluate if a rest period before extubation after a successful SBT trial could reduce the~     extubation failure rate.~   "
126206|NCT01915550|"~     Adding metformin to insulin therapy in pregnant women with diabetes mellitus who show insulin~     resistance may be equivalently effective to further raising the insulin dose~   "
126207|NCT01915537|"~     A prospective, multi-centric, cohort study to observe the efficacy difference between~     intensive classic DMARDs and Infliximab(IFX) with methotrexate(MTX) treatment in sever~     rheumatoid arthritis(RA) 28 joints disease activity score>5.1(DAS28>5.1) patients with poor~     prognostic factors.Primary objective is compare the difference of clinical remission rate~     between classic DMARDs and Infliximab with MTX treatment in severe RA patients with poor~     prognostic factors at week 30.~   "
126208|NCT01915524|"~     The purpose of this study is to determine whether the new RNActive derived lung cancer~     vaccine CV9202 in combination with local radiation therapy is safe, tolerable and immunogenic~     for the consolidation and maintenance treatment of stage IV non small cell lung cancer~     (NSCLC) after first-line chemotherapy or therapy with an EGFR tyrosine kinase inhibitor.~   "
126209|NCT01915511|"~     This registry will collect data on the strategies used to achieve a diagnosis of Idiopathic~     Pulmonary Fibrosis (IPF) and the treatment and management efforts applied throughout study~     follow-up, clinical outcome events and patient reported outcome data. Blood samples will be~     collected periodically throughout the study for use in future research efforts.~   "
126210|NCT01915498|"~     Study AG221-C-001 is a Phase 1/2, multicenter, open-label, dose-escalation, safety, PK/PD,~     and clinical activity evaluation of orally administered AG-221 in subjects with advanced~     hematologic malignancies that harbor an IDH2 mutation. The study includes a dose escalation~     phase to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose~     (RP2D) and an expansion phase to further evaluate the safety, tolerability and clinical~     activity of AG-221 in select populations.~   "
126215|NCT01915433|"~     Based on favorable preliminary data from ongoing studies testing the safety and tolerability~     of a nutrition, exercise and neuromuscular electrical stimulation funded by Direct MS, the~     investigators are proposing a pilot study focused on the Wahls Paleo plus Diet and Wahls Diet~     intervention to usual care. The intent is to measure the effect size of a Wahls Paleo plus~     Diet and the effect size of the Wahls Diet in reducing fatigue and improving quality of life~     scores as measured by fatigue severity scale score and MS quality of life 54 physical and~     mental scores and various subscale scores. Inclusion criteria is the presence of fatigue and~     the diagnosis secondary and primary progressive MS, progressive relapsing MS or~     relapsing-remitting MS with an expanded disability status scale score (EDSS) score of 4.5 or~     greater but otherwise stable medically. The Wahls Paleo plus (ketogenic diet) and the Wahls~     diet (modified paleolithic diet) groups will be instructed in completing a daily food log and~     receive coaching from registered dieticians who are expert in motivational interviewing. The~     control group will receive usual care. Biomarkers of nutrient levels (e.g. vitamin) and~     inflammation, blood sugar and insulin levels will be monitored. Additional blood will be~     frozen for future analysis. Nutrient (e.g. vitamin and antioxidant) intake will be assessed~     using food frequency questionnaires and 24 hr diet recalls. Test of endothelial function will~     be done at baseline and 12 weeks. Outcome measures will be change in quality of life and~     fatigue, endothelial function and blood biomarkers between enrollment and end of study at 12~     weeks. The hypotheses are that the diet intervention groups will experience reduced fatigue~     and improved quality of life and improved biomarkers 1) between zero and 12 weeks and that~     the wahls paleo plus (ketogenic diet) and the wahls diet (modified paleolithic diet) groups~     will experience more improvements in quality of life and reduced fatigue and in biomarkers~     than the usual care group experiences at 12 weeks. The usual care group will be given~     instruction in following both the wahls paleo plus and the wahls diet plans and how to~     utilize the daily food logs at the end of study visit. The usual care group will receive one~     nutrition coaching call to assist with implementation of the study diet.~   "
126216|NCT01915420|"~     The registry aims to evaluate the safety, performance and efficacy of the Everolimus-eluting~     bioresorbable vascular scaffold (BVS) system following rotational atherectomy in patients~     with complex de novo native coronary artery lesions in all-day clinical practice.~   "
126217|NCT01915407|"~     To test the AggreGuide A-100 AA Assay's effectiveness for detecting aspirin induced platelet~     dysfunction.~   "
126218|NCT01915394|"~     The principle purpose of this multicenter trial is to determine the definition, timing and~     the percentage of nosocomial RSV epidemics throughout Turkey. In addition, secondary purpose~     of the trial is to determine the prevention strategies of further spread of Respiratory~     Syncytial Virus (RSV) in the neonatal intensive care unit (NICU).~   "
126219|NCT01915381|"~     AIM: Improve adherence to physical activity in people with Intellectual disabilities with a~     Smartphone Application DESIGN: Randomized controlled trial SUBJECTS OF THE STUDY: People with~     intellectual disabilities in Occupational Center ( ASPROMANIS) INTERVENTION: DATA ANALYSIS:~     descriptive statistics, measuring central tendency and dispersion of the variables study.~     Inferential statistics will be made between intervention of key variables and outcome~   "
126220|NCT01915368|"~     The investigators will conduct a proof-of-concept study to provide preliminary evidence of~     efficacy of physical exercise dose on ambulatory function in adults undergoing sub-acute~     stroke rehabilitation.~   "
126221|NCT01915355|"~     The purpose of this research is to investigate the use of the Candela V-beam Pulsed Dye Laser~     for the treatment of onychomycosis, or nail fungus.~      Hypothesis: Complete nail clearance will occur in approximately half of patients after 3~     laser treatments.~   "
126222|NCT01915342|"~     The overall aim of the proposed study is to determine optimal parameter of focal muscle~     vibration for improving spasticity and identify neurophysiological mechanism in healthy~     subjects.~      In investigation I-1, subjects will undergo focal muscle vibration with 40, 80, 120 Hz~     frequency at the medial gastrocnemius muscles (mGCM). As a surrogate maker of spasticity,~     H-reflex and compound motor action potential (CMAP) of the tibial nerve at mGCM will be~     recorded pre, during, and post vibration.~      In investigation I-2, subjects will undergo focal muscle vibration with 0.1, 0.3, 0.5 mm~     amplitude at mGCM. H-reflex and CMAP of the tibial nerve at mGCM will be recorded pre,~     during, and post vibration.~      In investigation II, subjects will undergo focal muscle vibration with predetermined~     parameters by the investigation I at mGCM. H-reflex and CMAP of the tibial nerve and motor~     evoked potential at mGCM will be recorded pre, during, and post vibration.~   "
126223|NCT01915329|"~     The purpose of this study is to test a specific nerve stimulation protocol as therapeutic~     option in patients diagnosed with CRPS (complex regional pain syndrome) of the upper~     extremity.~   "
126224|NCT01915316|"~     The purposes of this study are to: i) confirm and improve the accuracy of the correlation~     between levels of Zinc in prostate tissue and the grade of prostate cancer in that tissue as~     determined through pathology; and ii) determine the levels of zinc in prostate tissue~     declared as non-cancerous by pathology and located in the vicinity of tissue declared as~     cancerous by pathology, and verify that the Zinc levels for the declared non-cancerous tissue~     are lower (statistically significantly) than the levels for benign tissue not in the vicinity~     of cancerous tissue.~   "
126225|NCT01915303|"~     This study is to assess whether pasireotide alone and combined with cabergoline will give~     reliefs on patients with recurrent, persistent and newly diagnosed Cushing's disease. The~     study will also assess study drug safety, the changes in Quality of Life and on clinical~     signs and symptoms of Cushing's disease.~   "
126226|NCT01915290|"~     This is a substudy of the Generation-100 study (NCT01666340). Self reported physical activity~     versus objectively measured physical activity and its correlation to maximal oxygen uptake in~     an elderly Norwegian population (observational study).~   "
126227|NCT01915277|"~     The purpose of this Phase I study is to determine the safety of a drug called dexmedetomidine~     (DEX) as part of a balanced general anesthetic and sedative strategy for neonates and infants~     undergoing corrective cardiac surgery that requires the use of cardiopulmonary bypass for~     congenital cardiac problems. This study will also design and validate a dosing schema for the~     use of DEX as described above.~   "
126228|NCT01915264|"~     The study is designed as non interventional to collect data on the safety especially, severe~     hypoglycemia or documented symptomatic hypoglycemic episodes and effectiveness of~     acarbose/metformin fixed-dose combination under real-life treatment condition in large sample~     of type-2 diabetes patients in India. The study objective is to evaluate severe hypoglycemia~     or documented symptomatic or asymptomatic hypoglycemic events reported as adverse events. The~     study will begin after the study approval by ethics committee. All patients with type 2~     diabetes on acarbose or metformin monotherapy and prescribed Glucobay M will be included in~     study after taking the informed consent. Patients will be observed for up to 24 weeks (2~     weeks).The study involves general examination of patients, collection of data like history of~     disease, concomitant medication, drug dose etc. The study is planned to enroll 10000 subjects~     from multiple study centers spread across India. The study data will be analyzed with~     appropriate statistical methods.~   "
126229|NCT01915251|"~     Background:~      - Vaginal yeast infections are caused by a fungus called Candida. Candida can live harmlessly~     in the vagina, but most women will have symptoms from a vaginal yeast infection at some point~     during their life. Antibiotics increase the risk for yeast infections, but it is unclear why.~     They may disrupt the balance of healthy bacteria in the vagina. This could make it harder for~     the body to fight off yeast infections. Researchers will give healthy women a common~     antibiotic or a placebo. They will study how the antibiotic affects bacteria and yeast in the~     vagina and other parts of the body. This will let researchers study the normal changes of~     healthy bacteria and yeast over time.~      Objectives:~      - To see how the study drug changes healthy bacteria in the vagina, and how these changes may~     increase the risk for yeast infections.~      Eligibility:~      - Healthy women ages 18 to 40 who are not allergic to penicillin.~      Design:~        -  Participants will be screened with medical history, physical exam (including vaginal~          exam), blood tests and tests for sexually transmitted diseases.~        -  Participants must take birth control pills for at least 3 months before, and during the~          study.~        -  Participants will take the study antibiotic or placebo for 10 days.~        -  Participants will have 7 study visits over 3 months. Visits will be timed around~          participants menstrual cycles.~        -  At the visits, participants will answer questions about their health and undergo tests.~          These may include swabs of the vagina, mouth and skin as well as blood tests. Vaginal~          fluid, saliva and urine will also be collected.~        -  Between visits, participants will collect stool and vaginal samples at home and bring~          them to the next clinic visit.~   "
126230|NCT01915238|"~     Background:~      - The Age-Related Eye Disease 2 Study (AREDS2) looked at two eye diseases. These were~     age-related macular degeneration (AMD) and cataracts. Participants in that study took~     supplement pills and some participants had additional pictures taken of their eyes. That~     study is now over. Researchers want to do a follow-up study after participants finish taking~     the pills, to see if they cause long-term effects on AMD. This study will be combined with~     follow-up visits of the AREDS2 study if possible.~      Objectives:~      - To learn more about the effect of oral supplements on AMD.~      Eligibility:~      - People who completed the AREDS2 study.~      Design:~        -  Participants will have up to 2 study visits over 6 18 months.~        -  Each visit will last up to 5 hours. The visits will be combined with annual follow-up~          visits in the AREDS2 study if possible.~        -  At each visit, participants will undergo an eye exam and photography.~        -  The eye exam includes testing sight, measuring eye pressure, and checking eye movements.~          To examine the inside of the eye, the pupil will be dilated with eye drops.~        -  Photographs of the inside of the eye may be taken during the eye exam and while the eyes~          are dilated.~        -  A contact lens may be placed on the eye briefly to look at the retina at the back of the~          eye.~   "
126231|NCT01915225|"~     Background:~      - Recent advances in cancer research have led to new therapies to treat the disease. It is~     important to continue these advances and discover new ones. To do that, researchers need~     tissue samples from solid tumors. This study will collect such samples from people already~     scheduled to have a procedure at the National Institutes of Health Clinical Center (NIHCC).~      Objectives:~      - To collect tissue samples for use in studying new ways to treat tumors.~      Eligibility:~      - Adults 18 years and older, with a precancerous or cancerous solid tumor who are scheduled~     to have surgery or a biopsy at the NIHCC.~      Design:~        -  Before their procedure, participants will have a small blood sample taken.~        -  Some participants will undergo leukapheresis. In this procedure, blood is removed~          through a tube in one arm and circulated through a machine that removes white blood~          cells. The blood, minus the white blood cells, is returned through a tube in the other~          arm. The procedure takes 3 4 hours.~        -  For all participants, during the surgery or biopsy, pieces of the tumor and pieces of~          normal tissue near it will be removed for this study. The rest of the tumor or~          precancerous growth will be sent to a lab for analysis.~        -  Participants will return to the clinic about 6 weeks after the operation for a routine~          checkup. Some may have to return for additional follow-up.~   "
126232|NCT01915212|"~     Background:~      - Herpes simplex virus type 2 (HSV-2) is a major cause of genital herpes. It can also cause~     serious infection in newborns and in people with weakened immune systems. It increases the~     risk of getting an HIV infection and of spreading HIV to someone else. Therefore, a vaccine~     that could prevent genital herpes could improve the general health of the world s population.~     Researchers want to study whether a new vaccine, HSV529, which may be used in the future to~     prevent herpes infections, is safe.~      Objectives:~      - To test whether a new herpes vaccine is safe.~      Eligibility:~      - Healthy adults 18 40 years old.~      Design:~        -  Participants will have 3 vaccination visits, 7 follow-up visits, and 3 follow-up phone~          calls over 1 year.~        -  Each vaccination visit will last about 4 hours.~        -  Participants will be screened with a medical history and physical exam.~        -  Participants will have a blood sample taken.~        -  Participants will be given the vaccine or a placebo, by injection from a needle. They~          will be monitored for 30 minutes to check for any allergic reaction.~        -  Participants will be given a diary card to record any symptoms they may feel later.~        -  At follow-up visits, participants will give a blood sample and answer health questions.~        -  In the phone calls, participants will answer health questions.~   "
126233|NCT01915199|"~     The implementation of lifestyle modifications, home blood pressure (BP) measurement, and~     optimization of antihypertensive drug therapy have been shown to improve BP control in~     tightly controlled research settings. The investigators objective is to determine the effect~     of these interventions in a primary care setting, with the family practitioners and nurses~     serving as the interventionists. The investigaotrs hypothesis is that a comprehensive~     intervention performed in a primary care setting would lead to better blood pressure control.~   "
126234|NCT01915186|"~     The aim of the study is to evaluate the effect of DHEA supplement on ovarian reserve markers,~     ovarian response to gonadotrophins and cycle outcomes in patients with normal and poor~     ovarian reserve.~      Study Hypotheses:~        1. DHEA supplementation would improve markers of ovarian reserve and ovarian response to~          low dose FSH stimulation in both normal and poor responders~        2. DHEA supplementation would improve IVF cycle outcomes~   "
130561|NCT01858402|"~     We conducted a prospective, randomized double-blind study to compare the effectiveness of~     intravenous paracetamol and dipyrone for preventing pain during early postoperative period in~     school-age children undergoing lower abdominal surgery with spinal anesthesia.~   "
126236|NCT01915160|"~     Nearly 9 million U.S. children (1 in 8) meet criteria for at least one mental health disorder~     at any point in time. Effective treatments exist for these disorders, but children and~     families who seek services rarely receive them; mental health providers need more support in~     the delivery of these interventions to ensure that children and families are receiving the~     best quality care. This project aims to improve the delivery of best practices for families~     who seek mental health care by developing creative, technology-based resources for providers.~     Once we have completed development of the tablet-based resources, we will conduct a small~     randomized study with 20 families to examine the feasibility and prepare for a large study to~     test the effectiveness of the resources.~   "
126237|NCT01915147|"~     The study is intended to explore changes in the composition and quantity of gut bacteria~     subject to treatment with strong pain medication. Two pain medications will be compared (OXN~     PR and OxyPR). Other gastrointestinal parameters will be assessed.~   "
126238|NCT01915134|"~     The investigators designed this study to evaluate the efficiency and the acute toxicities of~     recombinant human endostatin (endostar) combined with chemotherapy in the metastatic~     nasopharyngeal carcinoma (NPC).~   "
126239|NCT01915121|"~     The study main objectives are to enhance treatment decision making and improve quality of~     life and post-treatment health care among patients diagnosed with invasive bladder cancer.~      Bladder cancer (BL Ca) is the 5th most commonly diagnosed cancer in the US . BL Ca is more~     common among men than women and 90% of all patients are over the age of 55. Surgery to remove~     the bladder followed by one of three diversion techniques (i.e., ileal conduit, continent~     reservoir, and neobladder) is the standard therapy following invasive bladder cancer. The~     emotional, functional, physical, and social impact of invasive Bl Ca treatment on patients'~     QOL and adjustment can be devastating. This impact significantly varies by treatment option.~     Treatment decision making in for BL Ca is difficult at best and potentially susceptible to a~     number of cognitive and affective factors (e.g., patients' emotional reaction, values, and~     expectations). Thus, in addition to adjusting to a potential life-threatening disease, having~     to cope with uncertainty about the efficacy and outcomes of different treatment options adds~     to the overall distress and may impair effective decision-making. In spite of increasing~     efforts in health communication and patient education, no study has examined treatment~     decision making among invasive bladder patients or has provided an educational intervention~     to facilitate treatment decision making among this population. To this end, and guided by the~     Self-Regulation theory (SRT) that emphasizes the role of cognitive and emotional factors in~     decision making, we have designed and pilot tested the acceptability of a preliminary~     educational and training experiential intervention (ETE) to address this gap in the~     literature. The ETE intervention uses new and innovative educational strategies and methods~     to educate patients about their treatment options and to facilitate their treatment decision~     making.~   "
126240|NCT01915108|"~     This study was designed to determine the optimal dose of remifentanil that can prevent the~     complications associated with the removal of LMA without delaying emergence.~   "
126241|NCT01915095|"~     The goals of this study are to examine the physiology of Central Nervous System pathways~     contributing to the control of upper and lower extremity movements after SCI, and to promote~     the recovery of extremity movements by using non-invasive brain stimulation and motor~     training.~   "
126242|NCT01915082|"~     This study investigates possible beneficial effects of peri-operative treatment (i.e.~     pre-transplant initiation and prompt post-transplant continuation) with azithromycin in lung~     transplantation. Our hypothesis is that this therapy will improve early allograft function~     and outcome following human lung transplantation.~   "
126243|NCT01915069|"~     Combined oral contraceptive pills (COCs) are the most commonly used hormonal form of birth~     control in the United States with at least 87% of women of reproductive age reporting oral~     contraceptive use at some point in their lives (9). Despite their frequent use, the six and~     twelve month discontinuation rates for oral contraceptive pills are 31 and 47 % respectively~     (17), with common reasons for discontinuation attributed to the side effects of abnormal~     bleeding, headache, and weight gain.~      Additionally, COCs are contraindicated in certain groups of women as outlined by The Centers~     for Disease Control Medical Eligibility Criteria (11). Given the high prevalence of oral~     contraceptive users who commonly discontinue use secondary to side effects or who are not~     eligible for use as a result of underlying health conditions, the development of novel oral~     non-hormonal methods that are equally effective at pregnancy prevention are warranted.~      This current study aims to evaluate the effect of an FDA approved drug, Cilostazol, on human~     oocyte maturation. Such a study has not been conducted to date. If Cilostazol demonstrates an~     ability in humans to affect resumption of meiosis, then this non-hormonal agent could be uses~     as a possible contraceptive agent in the future. This knowledge would have profound~     reproductive health implications.~      The investigators propose that women undergoing treatment with the FDA approved dose of 100mg~     PO every 12 hours of Cilostazol will demonstrate an impairment of egg maturation in~     comparison to paired historic controls following ovarian follicle stimulation.~   "
126244|NCT01915056|"~     The purpose of this study is to determine whether information regarding GA and GA-driven~     interventions improves outcomes in older cancer patients receiving first-line or second-line~     chemotherapy by comparing rates of chemotherapy toxicity, hospitalizations, dose delays and~     early termination of treatment in patients with and without GA-driven interventions. The~     investigators will identify information that will be useful based on questionnaire responses~     and blood tests. These results will be used to better understand which recommendations and~     interventions will benefit older cancer patients. It is our hope that these tools, which are~     well-established at identifying areas of risk, will provide meaningful opportunities for~     intervention to promote your safety during cancer management. The investigators will be able~     to use this information to teach others on how to best care for adults aged 70 and older with~     cancer.~   "
126273|NCT01914679|"~     The purpose of this study is to evaluate the mechanisms of noninvasive cortical~     electrostimulation therapy known as Reduced Impedance Noninvasive Cortical~     Electrostimulation RINCE)in the management of fibromyalgia. Patients who meet the 1990~     American College of Rheumatology criteria for fibromyalgia will receive up to 24 RINCE~     treatments delivered by a medical device called NeuroPoint. Approximately 20 patients will~     receive a combination of active and inactive (sham) therapy treatments over a 16-week period~     followed by a 4 week post-treatment evaluation. Patients will also undergo three (3)~     functional brain imaging scans while participating in the study: the first prior to the~     commencement of treatment, another mid-treatment; and the third at the completion of the~     treatment period.~      The study's primary outcome measure will be the change from baseline in self-reported 24-hour~     average pain intensity. The study's hypothesis is that there will be a change in pain~     intensity as well brain functioning. We do not expect there to be a statistically significant~     improvement in pain intensity due to the small sample but do expect to see statistically~     significant changes in cortical function as measured by EEG and fMRI~   "
126245|NCT01915043|"~     Background: The cancer-related lymphedema (BCRL) is the abnormal accumulation of fluid in the~     lymphatic system and can develop immediately after surgery / radiotherapy of breast cancer,~     or may appear months later. In the literature there are numerous educational recommendations~     to avoid the appearance BCRL, but there is a lack of adherence to these recommendations. With~     the increase of mobile technologies among adults, the mobile devices can be an effective~     method to meet their education.~      Objective: To determine the effectiveness of therapeutic adherence a brief educational~     intervention through a smartphone-based application in the prevention of lymphedema in women~     with mastectomies.~      Method: 100 women survivors of breast cancer will be randomized to a group that will receive~     lymphedema prevention education and an app specific for better adhesion compared to the~     control group will receive education only. They will be monitored for 28 weeks by specific~     measures of lymphedema onset, volume and perimeter arm and hand strength lymphedema~     disability questionnaire and other measures of fatigue, quality of life and mood related to~     cancer.~      Discussion: The lack of adherence to health education is the main cause of failure in~     maintaining these brief educational interventions, whether the program is beneficial, it~     could be successfully implemented in clinical practice.~   "
126246|NCT01915030|"~     The present study is designed to investigate whether a high protein diet will preserve muscle~     mass during caloric restriction in older adults.~   "
126247|NCT01915017|"~     Many individuals with schizophrenia continue to hear voices, have false beliefs, and problems~     with attention, memory planning and everyday functioning even with medication treatment. The~     process of recovery in schizophrenia involves treating the whole person. This study will test~     a new Multimodal Cognitive Treatment (Mcog). Mcog works around problems in attention, memory~     and planning by using supports in the home such as signs, checklists, and alarms to improve~     everyday functioning. Mcog also helps the individual to examine the evidence for their~     beliefs and to deal with symptoms like voices that are not completely resolved with~     medications. We will compare 4 treatments to determine if this combined approach improves~     both symptoms and functioning for individuals with schizophrenia.~   "
126248|NCT01915004|"~     Children with non-neurogenic lower urinary tract dysfunction (NLUTD) represent a significant~     subgroup of pediatric urology patients, comprising up to 30 percent of some out-patient~     clinics. These children present with urinary tract infections (UTIs), abnormal voiding habits~     and various other lower urinary tract symptoms (LUTs) such as incontinence, urinary urgency~     and urinary frequency. Furthermore, the effects of NLUTD on a child's physical health, mental~     health and its potential negative clinical sequelae, which includes upper or lower urinary~     tract damage, must be taken into account when treating these children. These patients have~     complex needs requiring a significant amount of health teaching and it is imperative to~     determine the effectiveness of the various modes of delivering urotherapy. To determine the~     best modality to deliver urotherapy, this trial will compare the effectiveness of a 7 minute~     bladder training video to the effectiveness of standard urotherapy provided at a pediatric~     urology clinic at improving NLUTD/DES symptoms and quality of life in children between 5-10~     years of age.~   "
126249|NCT01914991|"~     Study Design: Randomized controlled clinical study. Introduction: Physiotherapeutic~     intervention aiming to restore mobility using different techniques as stretching, hot packs,~     exercises, therapeutic ultrasound and orthotics. No scientific evidence has been found~     correlating improved joint mobility and the use of these techniques. Application techniques~     of orthoses to reshape the soft tissues have been well detailed, however, no scientific~     evidence supporting their effectiveness on proximal interphalangeal joint (PIPJ) lag~     extension resolution using them as a single treatment has been found.~      Purpose of the Study: The purpose of the study was to test the effectiveness of static and~     dynamic orthosis in patients with a PIPJ flexion retraction using them as a single treatment~     compared with traditional combined therapies.~      Method: 63 participants were included in the study. Patients who used splints were compared~     to a control group who received conventional treatment. Active and passive mobility were~     measured before the experiment and again three months after. All the patients were measured~     under the same conditions and treated by the same hand therapist. The relationship between~     contracture resolution and function was measured using the DASH Spanish Version.~   "
126250|NCT01914978|"~     The objective of this research is to evaluate the effectiveness of a handbook for parents of~     children newly diagnosed with food allergy. The handbook was developed to provide information~     and strategies to support families in effectively managing food allergies while maintaining~     positive quality of life. Parents of children newly diagnosed with food allergy (within the~     past year) will be randomized into either the treatment condition (handbook) or a control~     condition (management of food allergy as usual). Participants will complete study~     questionnaires online at three time points: baseline (this will be before receiving the~     handbook for the treatment group), post-intervention (2-3 weeks after baseline), and~     follow-up (2-3 months after baseline). Data will be analyzed for change on study outcome~     measures and satisfaction with the handbook. Parents in the control group will receive the~     handbook following the conclusion of their participation in the study.~   "
126251|NCT01914965|"~     The influence of bupropion compared to placebo on the change of apathy as quantified by the~     apathy evaluation scale (AES-I, where I [informant] is a friend or family member familiar~     with the daily activities of the subject) in patients with HD after ten (10) weeks of~     treatment.~   "
126274|NCT01914666|"~     The purpose of the study is to assess the long term safety of duloxetine in participants with~     Chronic Low Back Pain (CLBP).~   "
126275|NCT01914653|"~     Prospective, single center, postmarket clinical study to obtain clinical experience with the~     use of SERI® Surgical Scaffold for soft tissue support and repair in breast reconstruction.~   "
126276|NCT01914640|"~     The waist circumference (WC) cut off levels of the Caucasian people may not represent the~     characteristics of different ethnic groups. The investigators aimed to determine sex specific~     WC cut off points to predict obesity, metabolic syndrome and increased cardiovascular risk in~     Turkish adults.~   "
126277|NCT01914627|"~     The study will be conducted to evaluate the efficacy and safety of a topical dimeticone~     formulation (Loion®) compared to 10% salicylic acid in octyl-dodecanol with 15%~     Macrogol-4-laurylether for the removal of scaling in patients with chronic psoriasis capitis~     (scalp psoriasis).~   "
126252|NCT01914952|"~     The purpose of this study is to examine the rise in plasma Beta-hydroxy-beta-methylbutyrate~     (HMB) after the dietary supplement has been administered in different forms. Prior studies~     have indicated that form of administration affects bioavailability of the HMB supplement.~     Therefore the current study will examine the bioavailability of a single dose of HMB given~     as:~        -  1.0g CaHMB in gelatin capsule~        -  0.8 g HMB free acid in a gelcap~        -  0.8 g HMB free acid in water~        -  1.0 g CaHMB in water~        -  0.8 g HMB free acid~      The randomized study will be a crossover design and each study subject will undergo the~     experimental protocol for each of the supplementation forms. Because of the different~     administration forms, the study will be an open label study. Briefly, the fasted participants~     will report to the laboratory in the morning. After an initial blood sample is taken, the~     dose of HMB will be administered. Blood will then be samples at 2, 5, 10, 15, 25, 35, 45, 60,~     90, 120, 180, 360, 720, and 1440 min post administration. A 24 h complete urine collection~     will also be performed. Participants will be given a light sack lunch 4 h after~     administration of the dosage and will remain at the laboratory through the 360 min sampling.~     Participants will then be allowed to leave the laboratory and return for the 720 min sampling~     after which the participants can eat an normal evening meal. Participants will return to the~     laboratory fasted the next morning for the final sample. A minimum 48 h washout period will~     be required before the next dosage form is administered and the process repeated.~   "
126253|NCT01914939|"~     This 3-year study is a trial of cognitive behavioral therapy (CBT), with or without oxytocin~     (OT) augmentation, in young adults with autism spectrum disorders. Participants will be~     randomly assigned to receive either a social skills-focused CBT intervention or a stress~     management/relaxation training CBT intervention. Participants will also be randomized to~     receive either a) intranasal oxytocin or b) a placebo drug, prior to the psychotherapy. The~     design of the study will enable examination of the efficacy of CBT for young adults with~     autism spectrum disorders. The design of the study will also allow examination of whether~     oxytocin enhances the efficacy of CBT.~      The investigators will perform functional (fMRI) and structural (MRI) imaging with all~     participants prior to treatment. This will enable examination of the relations between~     measures of brain function and structure, and improvements in target symptoms over the course~     of treatment. The aim is to discover whether there are neural characteristics that can~     identify which participants with autism spectrum disorders are most likely to respond to CBT~     interventions and/or oxytocin treatment.~   "
126254|NCT01914926|"~     Acute atrial fibrillation is the most common sustained, clinically significant dysrhythmia~     encountered in the emergency department (ED) and the most common dysrhythmia treated by~     emergency physicians. Atrial flutter is less common than atrial fibrillation but its~     management in the ED is very similar, and the majority of patients with atrial flutter also~     have atrial fibrillation. Symptomatic relief and ventricular rate control are generally the~     primary therapeutic objectives in the ED management of acute atrial fibrillation and flutter~     (AFF). The need for swift, appropriate action by the emergency physician is highlighted by~     the fact that up to 18% of patients with AFF develop potentially life-threatening~     complications such as congestive heart failure, hypotension, ventricular ectopy, respiratory~     failure, angina and myocardial infarction.~      Both beta-blocking agents and calcium channel blockers are commonly used to treat AFF in the~     ED. Metoprolol is the most commonly used beta-blocker; and diltiazem is the most frequently~     used calcium channel antagonist.[8] Diltiazem was released by the FDA for treatment of AFF in~     1992. Shreck et al. were the first to demonstrate both the efficacy of diltiazem in the ED~     management of AFF with rapid rate and its clear superiority over the previously most commonly~     used pharmacologic agent, digoxin.~      To date, only one prospective, randomized trial has compared the effectiveness of a calcium~     channel blocker (diltiazem) with a beta-blocker (metoprolol) for rate control of AFF in the~     ED. Despite the relatively small sample size (n=20 in each group) the authors concluded that~     both pharmacologic agents were similarly effective. In order to test this finding, the~     investigators conducted a prospective comparison of metoprolol and diltiazem for the~     management of patients presenting to the ED with AFF with rapid ventricular rate.~   "
126255|NCT01914913|"~     Retinitis pigmentosa is an eye disease in which there is damage to the retina. The retina is~     the layer of tissue at the back of the inner eye that converts light images to nerve signals~     and sends them to the brain.Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs) is~     used for this condition .~   "
126256|NCT01914900|"~     This is a phase II study of preoperative chemotherapy with docetaxel, cisplatin and~     5-fluorouracil (TPF) in locally advanced resectable oral cavity squamous cell cancer. The aim~     is to improve the rate of pathological complete response to induction chemotherapy in a~     molecular enriched population, consisting of patients with tumour harbouring a functional p53~     protein and/or showing low expression of beta-tubulin II.~   "
126257|NCT01914887|"~     The aims of our study are to evaluate the feasibility and safety of endoscopic injection of~     adipose tissue-derived mesenchymal stem cells in human subjects with moderate active~     ulcerative colitis, assessing the absence of adverse events associated to the investigational~     drug, and to evaluate the efficacy of the treatment to induce remission of moderate active~     ulcerative colitis, by improvements in disease activity index, quality of life index, and~     endoscopic index.~   "
126258|NCT01914874|"~     The aim of this study is to evaluate the feasibility and initial efficacy of an enhanced~     mindfulness-based program that includes mindful exposure to reduce anxiety and avoidance of~     social situations, and the Buddhist practice of self-compassion aimed at reducing harsh~     judgment and self-criticism that is characteristic of people with social anxiety disorder.~   "
126259|NCT01914861|"~     The purpose of this study is to examine a possible link between the time of day of exposure~     to a traumatic event and the risk of developing post-traumatic stress disorder. Clinical and~     biological correlates will also be examined from this perspective.~   "
126260|NCT01914848|"~     Multiprofessional Advance Care Planning and shared decision making for end of live care for~     terminal patients and their relatives.~      The aim of this study is to develop, implement and test a complex intervention for improving~     patients' preparation for and participation in end of life decisions. In cooperation with~     local, national and international partners, the investigators will focus on strategies to~     enhance advance care planning and shared decision making on end of life issues, and~     documentation and transferability of end of life decisions across health care settings in~     coordinated approach involving patients, their families and care givers (in and out of~     hospital).~   "
126278|NCT01914614|"~     The purpose of this research is to better understand the relationship between employment and~     breast cancer. Research is being conducted to understand how workplace factors influence~     breast cancer patients' ability to adhere to recommended cancer treatment and effectively~     recover from cancer. Investigators hope to use the findings from the study to help working~     breast cancer survivors make informed decisions about treatment and employment in~     collaboration with their employers and healthcare providers.~   "
126261|NCT01914835|"~     Cocaine/Crack Dependence has been associated with neuropsychological impairments mainly in~     executive functions and decision-making, which are predominantly managed by the prefrontal~     cortex (PFC) in the brain. However, none study in Neuropsychological Rehabilitation (NR) has~     been done in order to remediate the executive functioning in this population. The aim of this~     research is to investigate the impact of neuropsychological intervention based on the~     stimulation of cognitive functions such as attention, planning, organization, logical~     reasoning, executive functioning, and decision making. For this research it will be proposed~     interventions through motivational strategies and board games, especially chess because it~     has been associated with PFC functioning, since it is a game which requires complex cognitive~     abilities, such as: inhibitory control, mental flexibility, sustained attention, future~     planning and decision-making. There will be two groups of patients with cocaine/crack~     dependence (n = 56), one with NR (group A, n = 28) and another without NR (group B, n = 28).~     Group B will be submitted to the placebo intervention. Both groups will be submitted to an~     extensive battery of neuropsychological tests and psychopathological rating scales before and~     after interventions. A sub-group will also be submitted to functional magnetic resonance~     imaging and biomarkers measures (BDNF and cortisol). The hypothesis is that group A will~     present a pronounced improvement not only on the neuropsychological test but also on the PFC~     functioning in neuropsychological functions compared to group B.~   "
126262|NCT01914822|"~     1. To examine whether Ritalin has analgesic properties in healthy subjects.~        2. To examine if Ritalin analgesic effect is a pain specific phenomenon or a part of a~          broader, non-specific effect on high mental functions.~   "
126263|NCT01914809|"~     Preeclampsia is a frequent pathology. His etiology is doubtful.~      Targets :~      The study target is to identify a risk of preeclampsia group obtained with transcriptom~     analysis from circulating peripheric cells.~      Design:~      Multidisciplinary study (Gynaecology-Obstetric, Immunology, North CIC).~      The study of the transcriptional history of peripheral blood cells of 2patients groups:~        -  A patient group with a preeclampsia before 34 SA~        -  A patient group with a normal pregnancy paired on main confusion factors. Blood sampling~          will be collected at the diagnosis and 8 weeks after delivery.~      Results and perspectives~        -  Obtain a transcriptionnal signature of preeclampsia~        -  To identify new mechanism of the disease~        -  Identification of a specific transcriptom analysis with the comparison after delivery~          For long-term, the target is to identify risk patient in order to conduct easily~          preventive clinical trials in preeclamsia (primary prevention) and to consider a~          specific follow-up for risk patients.~   "
126264|NCT01914796|"~     This study will determine the safety and tolerability of PF-06412562 given orally to healthy~     volunteers. To determine the optimal dose for future studies, the concentration of the drug~     over time will be determined by periodic blood samples. The rate of eye blinks will be~     measured as an indicator of PF-06412562 action on the receptors of interest in the brain.~   "
126265|NCT01914783|"~     The primary hypothesis of the study is that in healthy elderly subjects experimental exposure~     to air pollutants increases sympathetic nervous system activity compared with sham (clean~     air) exposure. The secondary hypothesis of the study is that combined experimental exposure~     to air pollutants (particles + ozone) increases sympathetic nervous system activity to a~     greater extent than does the exposure to particles alone.~   "
126266|NCT01914770|"~     This pooled analysis will assess data from the Phase 3 belimumab registration studies~     BLISS-52 (aka BEL110752) and BLISS-76 (aka BEL110751). The analysis was pre-planned and~     agreed prior to the unblinding of either study. The primary objective is to evaluate the~     impact of belimumab treatment on a more severe subpopulation of systemic lupus erythematosus~     (SLE) subjects from BLISS-52 and BLISS-76 to aid physicians and payers in decision making.~     Subjects are from the modified Intent-to-Treat (ITT) population defined as randomized~     subjects who received at least 1 dose of study agent. This more severe subpopulation will~     have renal, neurological, haematological, or cardiovascular/respiratory organ domain~     involvement (as defined by a British Isles Lupus Assessment Group (BILAG) domain score of A,~     B or C in at least one of the domains) at baseline AND anti-double-stranded deoxyribonucleic~     acid (anti-dsDNA) positive (≥ 30 IU/mL) at baseline OR low C3 and/or C4 complement relative~     to the normal range at baseline.~   "
126267|NCT01914757|"~     The purpose of this study is to determine whether Benralizumab reduces the exacerbation rate~     in patients with a history of asthma exacerbations and uncontrolled asthma receiving ICS-LABA~     with or without oral corticosteroids and additional asthma controllers.~   "
126268|NCT01914744|"~     The aim of this study is to prove the superiority of entecavir over lamivudine for preventing~     the risk of hepatitis B virus reactivation in patients with non-Hodgkin lymphoma on~     CHOP/R-CHOP.~   "
126269|NCT01914731|"~     Fecal microbiota transplantation (FMT) is the reconstitution of normal flora by a stool~     transplant from a healthy individual to a C. difficile-infected recipient, and has long been~     a successful approach to recurrent/refractory C. difficile. The purpose of this project is to~     generate a frozen FMT inoculum from well-screened healthy volunteer donors which can be used~     repeatedly, particularly in those who do not have a healthy intimate partner or other related~     donor. Delivery of FMT has been performed colonoscopically, by fecal retention enema, or by~     the nasogastric route. This study will evaluate the safety and secondarily the efficacy of an~     inoculum administered by frozen orally-administered capsules.~      Subjects with recurrent/relapsing C. difficile infection will receive FMT via oral capsules~      The primary endpoint is assessment of safety as measured by clinical events (GI, procedural,~     systemic). Efficacy will be defined as a resolution of diarrhea off antibiotics for C.~     difficile, in the absence of a need for OTHER systemic antibiotics, i.e. resumption of a~     normal bowel status for the individual. Secondary efficacy endpoints include weight,~     subjective well-being and relative clinical improvement per standardized questionnaire, and~     subject qualitative assessment of, and satisfaction with, the transplant procedures. Subjects~     will be monitored for clinical safety by history and standard exams and the follow-up~     questionnaire as well as followed closely by phone and in person.~   "
126270|NCT01914718|"~     The aim of this study is to evaluate the efficacy and toxicity of dose-adjusted EPOCH-R in~     patients with MYC positive diffuse large B-cell lymphoma.~   "
126279|NCT01914601|"~     Extensive cervical spines movement during endotracheal intubation can result in serious~     neurological injury, especially in the patients with unrecognized cervical spines~     injury.[1-2] Moreover, direct laryngoscopy may be difficult if spine movement is limited~     because of arthritis, disc disease or a small gap between the occiput and the spinous process~     of the atlas.[3-4]~      Video laryngoscopes allow for intubation without alignment of the oral, pharyngeal, and~     tracheal axes which minimize the cervical movements, especially in the patients with~     restricted cervical movements. [5,6] Compared with the Macintosh laryngoscope, the use of~     AirWay Scope decreases median upper cervical-spine movement during intubation under in-line~     stabilization in patients with normal cervical-spine. [6] Unfortunately, the use video~     laryngoscopes are associated with longer times to tracheal intubation compared with the~     traditional techniques which may be attributed to the variable learning curves of the~     practitioners. [7-9]~      The King Vision video laryngoscope® (King Systems Company, a division of Consort Medical,~     Indianapolis, Indiana, USA) is an anatomically shaped, rigid laryngoscope that uses~     fiberoptic technology to view the larynx with micro camera offers a 160 degree of view~     potentially eliminating the need for neck flexion and head extension. [10]~      To the best of the authors' knowledge, there is no study has evaluated the King vision~     laryngoscope regarding the neck movement during routine tracheal intubation under general~     anesthesia.~   "
126280|NCT01914588|"~     Heart failure is a chronic disease associated with an increasing risk of morbidity,~     disability, repeated hospitalizations and mortality. Telemedicine could promptly identify~     signs of worsening cardiac disease in order to improve elderly patients' home care and~     quality of life by reducing the need of hospital admissions and sanitary costs. The~     investigators present a randomized, parallel-group trial to test the ability of a~     multiparametric remote monitoring system, in addition to standard care, to promptly identify~     worsening of heart failure and prevent hospital admission and mortality.~   "
126281|NCT01914575|"~     Use of dipole density mapping to identify activation in complex supraventricular tachycardias~   "
126282|NCT01914562|"~     This is an open label, randomized, balanced, single center, single dose, trial to assess the~     pharmacokinetic (PK) profile of OCA, glyco-OCA and tauro-OCA on an empty stomach (fasted~     condition) and following a high fat, high calorie meal (fed condition) in a 2-period,~     2-sequence, crossover manner.~   "
126283|NCT01914549|"~     Use of dipole density mapping to identify activation in complex supraventricular tachycardias~   "
126284|NCT01914536|"~     This project is an observational prospective study in which patients affected by an adult~     onset Pompe disease will be followed-up during three years using different clinical,~     analytical and radiological tests in order to know which is the natural history of the~     disease and which is the impact that treatment with recombinant enzyme has in the progression~     of the disease.~   "
126285|NCT01914523|"~     Failure to successfully intubate the trachea and secure the airway remains a leading cause of~     morbidity and mortality, in the operative [1-2] and emergency settings. [3-4]. When the~     concept of endotracheal intubation was developed, 100 years ago the procedure was performed~     blindly. Shortly thereafter, laryngoscopes were invented, allowing for direct visualization~     of the larynx with a viewing angle of 15 degrees [5]. Insufficient laryngoscopic view~     constitutes the main reason for difficult intubations [6].~      Video laryngoscopes provide an improved view of the glottis, as the camera is a few~     millimeters away from the glottis. The use of Glidescope [7-8] and AirTraq [9] laryngoscopes~     has superior glottis view and ease of tracheal intubation compared with the traditional~     Macintosh laryngoscope. Unfortunately, the use video laryngoscopes is associated with longer~     time to tracheal intubation compared with the traditional techniques which be explained with~     the variable learning curves of the practitioners. [10]~      The King Vision video laryngoscope® (King Systems Company, a division of Consort Medical,~     Indianapolis, Indiana, USA) is a relative newcomer to the video laryngoscopes of devices that~     claim to provide the perfect view for intubation via use of video and digital technology.~      The King Vision Video laryngoscope is a two piece design. It has a reusable monitor that~     attaches to disposable blades. Blades are made of high quality poly-carbonate plastic and~     house a complementary semi-conductor (CMOS) micro camera offers a 160 degree of view and LED~     light source.~      Up to best of the authors' knowledge, there is no current published or ongoing randomized~     controlled comparative study of the use of King Vision laryngoscope with traditional~     laryngoscope and other video laryngoscopes for endotracheal intubation.~   "
126286|NCT01914510|"~     This is a phase 2 study to see how useful, safe, and tolerable an investigational drug called~     ENMD-2076 is in treating patients with ovarian clear cell carcinomas.~      ENMD-2076 is an oral drug that works by blocking certain enzymes called Aurora A and tyrosine~     kinase from working. These enzymes are needed for cells to divide including cancer cells.~     ENMD-2076 also works by stopping the growth of new blood vessels which would provide the~     tumor with nutrients for it to grow. It is believed that by blocking Aurora A and tyrosine~     kinase enzymes from working and stopping new blood vessels from growing, the tumors may stop~     growing or shrink.~   "
126287|NCT01914497|"~     Study to determine the feasibility of the Acutus Medical System in obtaining data to create~     Dipole Density Maps of electrical activation in the right atrium in patients with typical~     atrial flutter.~   "
126288|NCT01914484|"~     This is the study to test combination regimen of Nilotinib and Ruxolitinib therapy for the~     treatment of patients with Philadelphia positive chronic myeloid leukemia (CML) or acute~     lymphoblastic leukemia (ALL) who is resistant to multiple tyrosine kinase inhibitor therapies~     with BCR-ABL kinase inhibition activity. Ruxolitinib is a tyrosine kinase inhibitor blocking~     alternative pathway independent of BCR-ABL mediated pathway, thus having a potential to~     overcome tyrosine kinase inhibitor resistance in Philadelphia positive CML or ALL patients.~     Phase I study will be conducted to define a recommended phase II dose (RPTD) and phase II~     study will examine the hypothesis that combinational approach will increase response rate of~     resistant CML/ALL patients, thus evaluating efficacy of the combination regimen.~   "
126325|NCT01914003|"~     Congenital sucrose-isomaltase deficiency (CSID) is a rare, genetic disease in which mutations~     in the sucrose-isomaltase (SI) gene cause digestion problems of sucrose resulting in diarrhea~     and abdominal pain. Children with chronic, idiopathic diarrhea or abdominal pain will have~     their sucrose-isomaltase gene assessed for a panel of known CSID mutations to determine the~     prevalence of these mutations in an enriched population and also determine functional~     deficiency using a breath test.~   "
126289|NCT01914471|"~     Objectives: We conducted a randomized controlled trial (RCT) of Students for Nutrition and~     eXercise (SNaX), a middle-school-based obesity-prevention intervention combining school-wide~     environmental changes, multimedia, encouragement to eat healthy school cafeteria foods, and~     peer-led education and marketing.~      Methods: We randomly selected schools from the Los Angeles Unified School District (LAUSD)~     and assigned five to the intervention group and five to a wait-list control group. School~     records were obtained for number of fruits and vegetables served, students served lunch, and~     snacks sold per attending student. Pre- and post-intervention surveys assessed psychosocial~     variables among 2,997 seventh-graders (75% of all seventh-graders across schools).~      Hypotheses: For the RCT of SNaX, we hypothesized that SNaX would lead to increases in the~     proportion of students served in the cafeteria (because SNaX markets cafeterias' healthy~     foods); increased fruit and vegetable servings (because SNaX increases access to~     sliced/bite-sized fruits and vegetables); decreased school store snack sales; and greater~     water consumption. We also hypothesized that SNaX would lead to more positive attitudes about~     the cafeteria and water, improve obesity-prevention knowledge, and increase intentions to~     drink water.~   "
126290|NCT01914458|"~     Lung cancer is the leading cause of cancer related death in Taiwan and world wide. The~     application of low dose helical computed tomography (CT) has been the milestone of lung~     cancer screening. Recently, The National Lung Screening Trial (NLST) shows screening with~     low-dose CT could reduce mortality from lung cancer. We conducted this clinical trial to~     determine the efficacy of low dose CT in early lung cancer screening in Taiwan.~   "
126291|NCT01914445|"~     The purpose of this study is to examine whether oral administration of Indigo Carmine~     together with Polyethylene Glycol (PEG), the usual colon preparatory solution, can be used~     instead of staining during the examination itself.~   "
126292|NCT01914432|"~     To evaluate efficacy and safety of YH16410 versus rosuvastatin and telmisartan monotherapies~     in patients with hypertension and hyperlipidemia~   "
126293|NCT01914419|"~     The study will evaluate whether prophylactic oxytocin administered in the third stage of~     labor via intravenous (IV) infusion or IV bolus reduces the rate of postpartum hemorrhage~     compared to intramuscular (IM) injection.~   "
126294|NCT01914406|"~     The aim of this study was to examine the effects of high intensity aerobic interval training~     (AIT) versus moderate continuous training (CON) in heart transplant recipients.~   "
126295|NCT01914393|"~     This is an open-label, 104-week, multicenter, extension study designed to evaluate the~     long-term safety, tolerability and effectiveness of flexibly dosed lurasidone (20, 40, 60 or~     80 mg/day) in pediatric subjects who have completed the 6-week treatment period in the~     preceding studies, D1050301, D1050325, and D1050326~   "
126296|NCT01914380|"~     The study aims to investigate the effectiveness of Eylea in patients with wet age-related~     macular degeneration in routine clinical practice in Germany. The study is purely~     observational, only data from routine treatment are to be collected. The treatment and~     treatment conditions are solely at discretion of the treating physician.~   "
126297|NCT01914367|"~     Six identical female twins aged 9-13 years will participate. One sib of each twin pair will~     be given Cervarix according to the 0, 1, 6 month vaccination scheme, while the other sib will~     be given Gardasil according to the 0, 2, 6 month vaccination scheme. Three blood samples will~     be taken (the first prior to vaccine administration, the second and third 7 days after dose 2~     and 3, respectively). The blood samples will be used to determine: 1) the magnitude the~     anti-HPV 16 and anti-HPV-18 antibody responses, 2) as well as the cross-reactive pattern of~     these responses towards related, non-vaccine HPV strains (HPV-31 and -33, and HPV-45). 3)~     plasmablast isolated from blood taken 7 days after the 3rd dose in the first place (and~     eventually after the 2nd dose also) will be examined for for the usage of VDJ and VJ segments~     in the immunoglobulin heavy (VH) and light (VL) heavy and light chains. Gene useg in B cells~     induced by Cervarix and Gardasil will be compared. Finally the cross-reactive potential of~     monoclonal antibodies obtained by eukaryotic expression of a series of heavy (VH) and light~     (VL) chains from single ASC isolated after the 3rd dose of a three-dose schedule of either~     Cervarix or Gardasil will be examined.~      The duration of the study is approximately 187 days. Five study visits will take place, over~     a time period of 6.5 months, followed by a telephone call after 12 months.~      The purpose of the study is to learn more about the molecular mechanisms underlying the~     cross-neutralizing capacity of AS04-adjuvanted HPV vaccine (Cervarix®) in comparison with the~     aluminiumhydroxyphosphate sulphate adjuvanted HPV vaccine (Gardasil®).~   "
126298|NCT01914354|"~     This is an observational multi-center study to determine whether any single immune monitoring~     test or a combination of tests obtained in the first 6 months after renal transplantation~     correlates with acute rejection or graft loss in renal allograft recipients receiving~     commonly used immunosuppressive.~   "
126299|NCT01914341|"~     The purpose of this study is to determine the effects of live music on physiological~     parameters in newborn infants. The mother is asked about the effects of music on her own and~     the child's wellbeing.~   "
126300|NCT01914328|"~     The purpose of this study is to determine the incidence of pulmonary complications in~     patients undergone major abdominal elective surgery performed under general anesthesia.~   "
126301|NCT01914315|"~     The purpose of this prospective study is to determine whether comprehensive cardiac~     rehabilitation is superior to usual disease management in the treatment of patients with~     heart failure with preserved systolic function (HFpEF) recently discharged after an acute~     heart failure event.~      The investigators hypothesize that the addition of bi-weekly structured exercise training and~     interaction with medical personnel will lead to a greater reduction in all cause~     hospitalization and mortality while providing additional functional and clinical benefits~     such as exercise capacity, quality of life and well-being.~      Furthermore the investigators seek to establish clinical, laboratory and echocardiographic~     predictors of hospital readmissions and cardiovascular events in the predefined HFpEF~     population.~   "
126302|NCT01914302|"~     Characterize expressed blood volume ≥1μL across representative, commercially available~     lancing device systems using finger sticks.~   "
126303|NCT01914289|"~     The purpose of this study is to confirm that prognosis of Intrahepatic Cholangiocarcinoma~     (ICC) with resection and radiotherapy ,to find which is safe and effective treatment.~   "
126304|NCT01914276|"~     Objectives: (1) To determine the incidence of lower-extremity lymphedema after staging~     surgery for endometrial cancer; (2) to describe lymphedema-related morbidity after staging~     surgery for endometrial cancer and (3) to evaluate pre- and post-operative quality of life in~     women with endometrial cancer who undergo staging surgery.~      Data analysis and risk/safety issues: The proposed study will consist of a convenience sample~     of women who undergo minimally invasive surgery for endometrial cancer over a 1 year period.~     The investigators anticipate enrollment of 75 to 100 women. Frequency tables and difference~     with its 95% exact confidence intervals between pre-and post-operative lower extremity~     lymphedema measurements and quality of life questionnaires will be estimated.~   "
126305|NCT01914263|"~     Cytokine-induced killer (CIK) cells are a heterogeneous subset of ex-vivo expanded T~     lymphocytes which present a mixed T-NK phenotype and are endowed with a major~     histocompatibility complex-unrestricted antitumor activity. Radical surgery is a good therapy~     for patients with solid tumor.However, tumor relapse is still a risk for those patients. Our~     hypothsis is that cytokine induced killer cells maybe decrease the recurrence rate. The~     purpose of this study is to evaluate the safety and tolerability of cord blood-derived~     cytokine induced killer cells in patients with solid tumor following radical resection.~   "
126306|NCT01914250|"~     The present study sought to examine the efficacy of two oral anesthetic drugs in reducing the~     pain associated with neonatal frenotomy.~   "
126307|NCT01914237|"~     Aim:Castor is a novel single-branched stent graft system for endovascular repair of aortic~     arch dissection. This is a prospective, one-arm, open, multi-center, pre-market study of~     Castor stent to evaluate its efficacy and safety in treatment of aortic dissection.~      Number of patients: 70 patients will be included and undertaken endovascular repair with~     Castor stent.~      Follow-up: 1.aortic computed tomographic angiography (CTA) examination 6 and 12 months after~     the surgery 2.telephone or clinical follow-up 30 days and 2-5 years after the surgery~      Primary Outcome Measure: success rate of endovascular repair for efficacy measurement.~      Secondary Outcome Measure: 1 year stent related adverse event rate for safety measurement.~      Other Outcome Measures:~        1. efficacy:~             -  1 year success rate of treatment~             -  1 year patency rate of branch stent~        2. safety:~             -  in-hospital mortality~             -  complication rate of neural system~             -  1 year dissection or stent related mortality~   "
126308|NCT01914224|"~     Reduction in sodium consumption is important approach in public health care. In general~     population, reduction of sodium intake can reduce the future development of hypertension and~     cardiovascular event. Meanwhile, enhancement of potassium consumption is also important to~     reduce blood pressure and cardiovascular events. We hypothesized that combined education of~     low sodium and high potassium consumption is more effective in reducing blood pressure~     compared to dietary education of low sodium consumption only.~      The present survey study was designed to test the effectiveness of combined education of low~     sodium and high potassium consumption in blood pressure reduction and improvement of other~     variables.~   "
126309|NCT01914211|"~     This is an observational, prospective study to evaluate the role of tranexamic acid in~     reducing blood transfusion in neonates undergoing cardiopulmonary bypass.~   "
126310|NCT01914198|"~     The investigators are proposing a study where the investigators would give a survey to the~     parents of patients having a sleep study. The survey would contain questions relating to~     symptoms of sleep apnea and then the investigators would correlate the parent answers to the~     results of the sleep study.~   "
126311|NCT01914185|"~     The objectives were to 1) make students eat healthier and be more active; and 2) prevent~     overweight and obesity. Children will therefore be less likely overweight or obese. Beginning~     in January 2008, the Alberta Project Promoting active Living and healthy Eating in Schools~     (APPLE Schools) was implemented in 10 schools throughout the Canadian Province, Alberta.~     Full-time School Health Facilitators were placed in each of the schools to implement what is~     know in Canada as Comprehensive School Health (CSH). In the United States, CSH is more~     commonly referred to as Coordinated School Health, while the synonymous term Health~     Promoting Schools is often used in Australia and Europe. The project was evaluated annually~     in the spring from 2008 to 2011 and as of 2009 evaluations included the use of time-stamped~     pedometers. The comparison group included approximately 150 schools that were randomly~     selected to reflect the population of Alberta, Canada. Twenty of these randomly selected~     schools also participated in data collection which involved the use of time-stamped~     pedometers.~   "
126312|NCT01914172|"~     Kallmann syndrome (KS), also known as congenital hypogonadotropic hypogonadism (CHH), is a~     rare endocrine disorder that is characterized by failure to undergo puberty combined with~     infertility. KS/CHH patients face a number of psychosocial burdens related to delays in~     diagnosis, inadequate access to expert care, and lack of information about the condition. As~     such, there is some evidence to suggest that KS/CHH patients have unmet health needs. This~     study aims to identify the needs of patients and understand the issues that must be overcome~     to achieve improved health and quality of life.~   "
126313|NCT01914159|"~     The Ranibizumab in Pigment Epithelium Tears Secondary To Age-Related Macular Degeneration~     (RIP) Study is a prospective, multicenter, uncontrolled, interventional phase 2 clinical~     trial that investigates the effect of fixed monthly intravitreal injections of ranibizumab~     (Lucentis, Novartis Pharma, Germany) on visual acuity and retinal morphology over a study~     period of 12 months in 30 patients.~   "
126314|NCT01914146|"~     In the proposed study, the investigators examine in older adults with Type 2 diabetes the~     impact of beginning insulin therapy on the orthostatic drop in blood pressure as well as the~     response of arterial blood pressure and Doppler measures of cerebral blood flow during~     upright tilt. The investigators hypothesize that in older adults with Type 2 diabetes, the~     cardiovascular effects of insulin would precipitate or worsen orthostatic intolerance not~     present at baseline.~   "
126315|NCT01914133|"~     The current proposal will determine if blocking carbohydrate intake in the small intestine~     with Acarbose can be a possible therapy for older adults with (PPH) Post Prandial Hypotension~     (a drop of blood pressure after eating), which can result in falls.~   "
126519|NCT01911442|"~     This is a randomized, double-blind, placebo-controlled study designed to evaluate the~     efficacy and safety of 2 fixed doses of lurasidone (20 mg/day and 60 mg/day) for 6 weeks~     compared with placebo in pediatric and adolescent subjects with irritability associated with~     autistic disorder who reside in the community setting.~   "
126316|NCT01914120|"~     The goal of this study is assess the quality of life of advanced non-small cell lung cancer~     (NSCLC) patients who are undergoing first-line chemotherapy, analyze the current status and~     tendency of quality of life (QOL). The method is to use the Functional Assessment of Cancer~     Therapy-Lung (FACT-L) scales, assess the quality of life before the chemotherapy, after 1st~     cycle of chemotherapy and after 2nd cycle. After 3 time-points, investigators analyze all the~     subscales and constructs of FACT-L. The assumption is the quality of life will be better~     after 2 cycle of chemotherapy.~   "
126317|NCT01914107|"~     This study aim at the advanced malignant tumor patients who suffer from cancer pain,~     investigate the current status of cancer pain treatment, and study the effects in pain~     control and quality of life improvement using the method of real-time monitoring and~     treatment instruction of cancer pain. This study is a randomized, controlled, single center~     clinical study. After recruitment, the subjects will randomly assign to standard cancer pain~     treatment group and standard cancer pain treatment plus real-time dynamic monitoring and~     treatment intervention of cancer pain using the cloud computing concept system. And then,~     assess the alleviation of cancer pain and quality of live. The assumption is the system will~     alleviate the cancer pain efficiently.~   "
126318|NCT01914094|"~     Low levels of physical fitness increase the risk of death in patients with cardiovascular~     disease. Although cardiac rehabilitation programs improve the health of patients after heart~     surgery, most patients are not referred until after surgery. Therefore, the purpose of this~     study was to determine if an exercise pre-habilitation (i.e., Prehab) program before heart~     surgery would improve the health of patients before surgery and whether these improvements~     would be maintained after surgery.~      The investigators hypothesized that Prehab would promote the health of patients before heart~     surgery, and these improvements would be maintained three months post-operatively, as~     compared to patients who received standard care.~   "
126319|NCT01914081|"~     The purpose of this study is to determine if resveratrol can improve heart function and~     quality of life. Although, population studies have revealed that a mild to moderate intake of~     red wine reduces cardiovascular disease risk in humans, clinical studies that evaluate the~     potential heart benefits of resveratrol in patients with non-ischemic cardiomyopathy have not~     been previously reported. Accordingly, this research is being done because it will fill this~     deficiency in the information available in the literature and establish the clinical benefits~     of resveratrol in patients with this type of heart disease.~   "
126320|NCT01914068|"~     Patients' ability to tolerate surgery is associated with physical fitness: less fit patients~     have an increased rate of death and serious complications following major surgery. Combined~     chemotherapy and radiotherapy (x-rays) prior to rectal cancer surgery is known as~     neo-adjuvant chemoradiotherapy (NACRT) and is associated with improved cancer removal but~     adversely affects physical fitness. In Liverpool, the investigators have pre-pilot data~     showing that NACRT reduces objectively measured physical fitness (measured by cardiopulmonary~     exercise testing) in patients having surgery. This pre-pilot study investigated the effects~     of a 6-week structured responsive endurance training programme (SRETP) after NACRT and before~     cancer surgery. This programme has improved both their fitness and their health related~     quality of life(HRQL). Now, the investigators are undertaking a randomised controlled trial~     to compare changes in patient's physical fitness in response to SRETP with a group of~     patients who will be given exercise advice. The SRETP group will exercise 3 times a week for~     9 weeks. The investigators will make objective measurements of physical fitness in both~     groups. The investigators will monitor patient's perceptions of the training programme, HRQL,~     daily activity (using an accelerometer), and outcomes after surgery. The investigators~     believe that, patients in the exercise group will improve their physical fitness prior to~     surgery, change behaviour towards exercise, improve activity and HRQL following NACRT. These~     results will contribute to the design of a large, multi-centre trial to determine whether a~     SRETP increases physical fitness with a reduction in adverse outcome following surgery. The~     investigators will conduct an adequately powered randomized controlled trial (RCT) comparing~     a SRETP with 'exercise advice' in 46 rectal cancer patients. Specifically, we will test the~     following hypotheses and outcomes: PRIMARY HYPOTHESIS A 9-week, structured responsive~     endurance training programme (SRETP) compared with a control group (no training) will result~     in a clinically significant difference in physical fitness (2.0ml/kg/min VO2 at LT)~     post-NACRT prior to surgery.~      SECONDARY OUTCOMES~        1. A 9-week SRETP compared with a control group (no training) will result in a clinically~          significant difference in physical fitness (2.0ml/kg/min VO2Peak) in patients who have~          had NACRT prior to surgery.~        2. SRETP following NACRT and prior to cancer surgery will provide psychological health~          benefits and improve patient's HRQL (assessed by semi-structured interviews and~          questionnaires -EORTC QLQ-30 and EQ-5D). This will provide vital exploratory information~          that will inform a future application to deliver a larger appropriately powered RCT~          exploring the hypothesis that patients with greater pre-operative fitness will encounter~          lower postoperative morbidity and mortality. Specifically, these exploratory outcomes~          are:~      EXPLORATORY OUTCOMES~        1. To investigate whether SRETP following NACRT and prior to surgery is associated with a~          change in overall physical activity (assessed by the number of steps while active using~          an accelerometer).~        2. To investigate whether there is a change in the day 7 surgical morbidity (using the~          Post-Operative Morbidity Survey) and mortality.~        3. The effect of SRETP on cancer downstaging post-NACRT (Tumour, Node and Metastasis~          Staging-TNM staging).~   "
126321|NCT01914055|"~     demonstrate that FD-OCT guidance is feasible and possibly results in reduction of~     frequency-domain Optical Coherence Tomography-defined residual thrombus burden after~     thrombus-aspiration.~   "
126322|NCT01914042|"~     Clinical, psychophysical, behavioral or genetic factor will predict the response to opioid~     treatment in patients with chronic neuropathic pain.~   "
126323|NCT01914029|"~     The purpose of the study is to add to the knowledge of mechanisms of immune health.~     Parameters of the immune system will be followed over time in volunteers allergic to dust~     mites and bee sting after receiving immunization therapy. This information will be compared~     to healthy volunteers without allergy. We aim to bring new understanding of immune processes~     by this comparison.~   "
126324|NCT01914016|"~     People with Multiple Sclerosis (pwMS) often experience 'foot-drop' which means that the foot~     is not adequately lifted during the so-called swing phase (foot is off the ground) during~     walking which can lead to trips and falls. Functional Electrical Stimulation (FES) to the~     shin muscles will aid lifting of the foot and therefore reduces the risk of trips and falls.~     There have been several studies showing the benefits of FES to the walking of pwMS. The~     proposed study aims to optimise the FES prescription and fitting care pathway for pwMS in~     Edinburgh and the Lothians This will be achieved firstly through a survey to all clients with~     MS in the last 5 years who have been regarded as suitable for FES. Secondly, a pilot study~     will assess the suitability of the use of simple clinical measurement (electrogoniometry)~     which will allow the measurement of the degree of foot-drop. The degree is foot drop is~     usually assessed by the physiotherapist using visual observation. Using a small device which~     can be quickly fitted to the patient's lower and foot for the duration of a 2-6 minute walk,~     the physiotherapist will be able to quantify the degree of foot drop over time. Such a~     measurement is especially important for people with MS who are often affected by increased~     mental and physical fatigue.~      Our first hypothesis is that the degree of foot-drop at the end of the walk is increased~     compared to the start of the walk. Secondly, we hypothesise that the degree of foot drop is~     less when the participant walks with the assistance of Functional Electrical Stimulation at~     their next clinical appointment.~   "
126520|NCT01911429|"~     Efficacy and Safety study of Lurasidone in pediatric patients.~   "
126326|NCT01913990|"~     For breast cancer patients receiving chemotherapy regimens, the use of a validated emesis~     (nausea and vomiting) risk calculator will provide superior anti-emetic (nausea and vomiting)~     control compared with standard anti-emetic regimen. The risk calculator has the potential~     to provide more individualized anti-emetic regimen by decreasing the use of toxic/costly~     anti-emetics in patients at low risk and possibly more importantly enhancing the appropriate~     anti-emetic regimen in patients at high risk.~   "
126327|NCT01913977|"~     This prospective study includes 5 patients with ARDS (Acute Respiratory Distress Syndrome)~     treated by mechanical ventilation. In case of respiratory acidosis, extracorporeal CO2~     (carbon dioxide)removal might be necessary. We hereby work with the Abylcap system with the~     oxygenator Lilliput2 as CO2 remover (Bellco, Italy).~      The patients (M/V) are older than 18, not pregnant, have a BMI<30, and no contraindication~     for anticoagulation therapy.~      Under standard conditions patients are treated with a blood flow of QB=300mL/min and a gas~     flow (100% 02) of QG=7L/min. Blood sampling is performed from the arterial bloodline in the~     patients at 0, 1h, 3h, 24h, 48h, 72h, 96h, and 120h.~      A parameter study is also performed to optimise CO2 removal. Herewith, blood samples (1mL)~     are taken from the inlet and outlet line of the Lilliput2 at the previously mentioned time~     points and for different flow setting: Blood flow (QB) 200-300-400mL/min and gas flow (QG)~     1.5, 3, 6, 7, 8L/min~      Blood samples are analysed for the different blood gases from which the extraction in the CO2~     remover can be calculated for each setting of QB (blood flow) and QG (gas flow).~   "
126328|NCT01913964|"~     To assess the effects of Acetyl-L-Carnitine administration on work productivity, daily~     activity, and fatigue in subjects with chronic hepatitis C treated with~     Pegylated-Interferon-α2b and Ribavirin.~   "
126329|NCT01913951|"~     This phase I trial studies the side effects and the best dose of vosaroxin when given~     together with azacitidine in treating patients with myelodysplastic syndromes. Drugs used in~     chemotherapy, such as vosaroxin and azacitidine, work in different ways to stop the growth of~     cancer cells, either by killing the cells or by stopping them from dividing.~   "
126330|NCT01913938|"~     The purpose of the study is to find out whether non-responsiveness to therapeutic recombinant~     human granulocyte colony-stimulation factor (rhG-CSF) is associated with hemophagocytosis in~     critically ill adult patients with cytopenias.~   "
126331|NCT01913925|"~     The objective of this research is to determine if tyrosine, an amino acid found in~     protein-containing foods, will mitigate the cognitive deficits and adverse effects on~     behavior and mood produced by exposure to military stress. This study was conducted at the US~     Navy Survive, Evade, Resist, Escape (SERE) school at Brunswick, Maine (ME).~      Tyrosine is the dietary precursor of the catecholamine norepinephrine, a key brain~     neurotransmitter that is critical for the central nervous system (CNS) response to various~     types of acute stress. Psychological stress increases catecholamine turnover in the brain,~     increasing the requirement for tyrosine to support synthesis of norepinephrine. Animal and~     human studies have shown that tyrosine supplementation can produce beneficial effects on~     cognitive and physiological functions during exposure to a variety of acute stressors.~      This project will determine if volunteers treated with supplemental tyrosine during stressful~     phases of SERE training experience less degradation in cognitive performance and mood than~     volunteers treated with placebo. Tyrosine or placebo will be administered in a specially~     developed food bar provided to volunteers. The bar is part of a prototype of ration-component~     designed for use during assault operations. A between-subjects, double blind experimental~     design will be employed. Tyrosine, an amino acid found in most protein-containing foods, has~     been tested in hundreds of volunteers without adverse effects.~      Approximately 100 volunteers will be recruited from several SERE classes to ensure up to 80~     volunteers complete the study. They will be tested during several portions of SERE. A~     comprehensive but brief battery of cognitive tests, as well as saliva samples, and heart rate~     data will be collected in a manner that does not interfere with ongoing training.~      Hypotheses:~        1. Exposure to the stressors of SERE school will adversely impact cognitive performance and~          mood of volunteers.~        2. The adverse effects of psychological stress on cognitive performance and mood during~          SERE school will be reduced when volunteers are given supplemental tyrosine compared to~          placebo treatment.~   "
126332|NCT01913912|"~     Stimulants alleviate information processing and task performance deficits in Attention~     Deficit/Hyperactivity Disorder (ADHD). Long acting formulations of amphetamines such as~     lisdexamphetamine dimesylate (LDX) are especially valuable as they target the school day and~     improve classroom performance. Although stimulants have been widely used in treatment of~     ADHD, the exact mechanism action and effect on task performance is not completely known.~      According to the State Regulation Deficit (SRD) model, children with ADHD have difficulty~     regulating their levels of arousal/activation during tasks in response to the changing~     demands of the environment. This leads to problems with downregulating overaroused states and~     upregulating underaroused states. According to this view, stimulants exert their therapeutic~     effect (in part) by optimising arousal/activation levels - especially during states of~     underarousal/activation. Arousal/activation levels can also be altered by extrinsic factors~     such as event rate (ER), e.g., the rate at which information is presented. Multiple studies~     suggest that very fast and very slow events can both cause problems for individuals with~     ADHD, related to overarousal and underarousal state respectively. Putting these intrinsic~     (stimulants) and extrinsic (ERs) factors together leads to the prediction that changing the~     rate at which information is presented in a task may alter the efficacy of stimulants and~     affect the optimal stimulant dose level. More specifically, one dose of stimulant that may be~     optimal on slow ER tasks (as it increases arousal/activation level) may be less effective~     under high ER tasks because in such a setting arousal/activation level needs to be lowered~     and not increased further. Adding stimulants to an already overactivated state may exacerbate~     the associated problems. The implication of this is that a different dose of stimulant will~     be needed under different environmental conditions for optimal performance. For example,~     children with ADHD might require different dosage in the classroom setting to optimize~     performance. In addition, the neuropsychological basis of performance deficits and~     improvement by ER and stimulants are also unclear. According to the SRD model, the underlying~     mechanism can be specific problems in motor activation/preparation or effort regulation.~     Event-related potentials (ERP), pupil size measurements and cardiac measures enable us to see~     objectively how motor activation/preparation and effort are affected by ER and simulants.~      In this study the investigators aim to test these predictions of the SRD model and identify~     the neurobiological basis of stimulant action.~   "
126333|NCT01913899|"~     The aim of the study is the measurement of the short term effect of post surgical mirror~     therapy concerning pain intensity and frequency of patients with upper or lower amputation in~     comparison to standard occupational or physical therapy. The hypothesis is that patients in~     the intervention group (mirror therapy) suffer significantly less from phantom limb pain and~     pain attacks within a follow-up period of 4-8 weeks.~   "
126334|NCT01913886|"~     This study will evaluate the safety and efficacy of intracoronary injection of mesenchymal~     stem cells (MSCs) to repair heart function in patients with myocardial ischemia.~   "
126335|NCT01913873|"~     Among patients undergoing heart surgery, a measurable degree of heart muscle tissue injury is~     expected. The level of injury can be shown by measuring the blood levels of specific~     molecules called cardiac biomarkers. Those cardiac biomarkers are often used in the acute~     cardiac care to diagnose a myocardial infarction.~      Postoperative heart infarction remains a frequent and important complication after heart~     surgery.Therefore it is important to recognize any cardiac event in patients who underwent~     heart surgery. Although different diagnostic tools can be used to recognize these events, few~     is known about the value of those cardiac biomarkers to diagnose a myocardial infarction~     after heart surgery.~      In this study the investigators will describe the concentration changes of those cardiac~     biomarkers over time in patients undergoing heart surgery, and the investigators will try to~     establish a upper level value who could indicate heart infarction.~   "
126336|NCT01913860|"~     Background The over use of antimicrobials is recognised as the main selective pressure~     driving the emergence and spread of antimicrobial resistance in human bacterial pathogens.~     Urinary Tract Infections (UTIs) are one of the most common infections presented in primary~     care and empirical antimicrobial treatment is currently recommended. Previous research has~     identified that a substantial proportion of Irish GPs prescribe antimicrobials for UTI that~     are not in accordance with the Guidelines for Antimicrobial Prescribing in Primary Care in~     Ireland.~      Aim To design, implement and evaluate the effectiveness of a complex intervention on GP~     antimicrobial prescribing and adult (18 years of age and over) patients' antimicrobial~     consumption when presenting with a suspected UTI.~      Methods The SIMPLE study is a randomised three armed intervention with practice level~     randomisation. Adult patients presenting with suspected UTI in primary care will be included~     in the study.~      The intervention integrates components for both GPs and patients. For GPs the intervention~     includes interactive workshops, audit and feedback reports and automated electronic prompts~     summarising recommended first line antimicrobial treatment and, for one intervention arm, a~     recommendation to consider delayed antimicrobial prescribing. For patients multimedia~     applications and information leaflets are included. A minimum of 920 patients will be~     recruited through 30 practices. The primary outcome is change in prescribing of first line~     antimicrobials in accordance with the Guidelines for Antimicrobial Prescribing in Primary~     Care in Ireland. The intervention will take place over 15 months. Data will be collected~     through a remote electronic anonymised data extraction system (iPCRN), a text messaging~     system and through GP and patient interviews and surveys. The intervention will be~     strengthened by the implementation of a social marketing framework and an economic~     evaluation.~   "
126337|NCT01913847|"~     The purpose of this study is to investigate the safety and clinical efficacy of HGP1207~     (Sildenafil) in subjects with pulmonary hypertension associated with systolic heart failure.~   "
126338|NCT01913834|"~     Osteoporosis is a reduction in bone density that increases the risk of fractures;~     particularly of the spine, hip and wrist. Osteoporosis is estimated to affect 200 million~     women worldwide - approximately one tenth of women aged 60, one-fifth of women aged 70,~     two-fifths of women aged 80 and two-thirds of women aged 90. Treating osteoporosis and the~     associated fractures costs the NHS more than two billion pounds per annum.~      Teriparatide is a drug currently prescribed for some osteoporosis patients by their doctor to~     be taken by injection. It is currently the only drug available which promotes the deposition~     of new bone as opposed to preventing resorption. This is the drug treatment we will be~     studying in this clinical trial.~      The drug is of a type that cannot normally be taken as a swallowed pill. This type of drugs~     tends to be delivered by injection, as is currently the case for teriparatide. Injections~     have numerous limitations and are disliked by patients.~      This trial will assess how well the nasal spray devices work, how long the drug stays in the~     nose and also how well the drug enters the bloodstream.~   "
126339|NCT01913808|"~     Postoperative anaemia are common in patients undergoing major orthopaedic surgery. The main~     consequence of perioperative anaemia is an increased risk of red blood cell (RBC)~     transfusions. Allogeneic RBC transfusion and anaemia are associated with higher postoperative~     mortality and morbidity.~      The aim of this study was to compare the efficacy of postoperative i.v. ferric carboxymaltose~     (FCM) and oral ferrous glycine sulphate (FS) for early improvement of postoperative anaemia~     after total knee arthroplasty and whether iron treatment could facilitate recovery from~     surgery.~   "
126340|NCT01913795|"~     The investigators aim to pilot the role of school based intervention consisting of enhanced~     integrated pest management, classroom air purifiers and cleaning improves asthma morbidity.~   "
126341|NCT01913782|"~     Chronic low back pain (CLBP) is the most prevalent form of chronic pain, and the most common~     reason for disability in working-age population [2]. CLBP has also been reported associated~     with many abnormal brain anatomy and function which includes the reduction in cortical gray~     matter in the bilateral dorsolateral prefrontal cortex (DLPFC), thalamus, brain stem, primary~     somatosensory cortex, and posterior parietal cortex. [3-5] There are already many studies~     that demonstrated abnormal cortical function for people with CLBP [6-10]. Meanwhile, DLPFC~     was also reported to be influenced by many pain process which included pain modulation~     [11-13], placebo analgesia [14, 15], pain control [16, 17]or pain catastrophizing[18]. And~     recent report has showed that effective treatment of chronic back pain patients reverses~     abnormal DLPFC function[19]. Meanwhile, epidural steroid injection has been performed in~     clinical for routinely managed for low back pain patients. Patients refused or have no~     indication for surgery or have little response to rehabilitation may consider this~     management. There was good evidence for short- and long-term relief of chronic pain secondary~     to disc herniation with local anesthetic and steroids[20, 21]. However, the impact of this~     treatment on functionalMRI (fMRI) has never been investigated. The investigators research~     will try to solve this issue.~      This study will provide a good relationship for the pain fMRI image in brain after local~     lumbar spine management. And the investigators also want to perform the first data that~     showed local lumbar analgesia have the impact on brain image change.~   "
126342|NCT01913769|"~     Background:~      Chemoradiation is an important treatment strategy of locally advanced inoperable or~     unresectable disease. Radiation dose is an independent predictor of a pathological response.~     In addition, chemotherapy has further impact on the aspect of outcome. Improvements in local~     treatment delivery are needed to facilitate dose escalation and to minimize toxicity. There~     have been sequential improvements in tumor localization, radiation planning and delivery over~     the years. Helical tomotherapy nowadays provides the most precise data on radiotherapy (RT)~     dose delivered to thoracic malignancies, and allows greater sparing of the heart from doses~     associated with increased complications. However, heart disease shows a wide spectrum of~     pathologies, and multiple risk factors related. The damage of the myocytes may lead to not~     only myocardial perfusion defects, but also in functional deterioration, or even in~     biomarkers.~      Since the impact of radiation-induced heart injury in patients with thoracic malignancies~     (including esophageal cancer, lung cancer, et al) is poorly documented, we try to delineate~     of RT-related cardiac effects and clinical impacts.~      Objective:~      This study aims to investigate the correlation of post-tomotherapy cardiovascular effects~     with myocardial perfusion and cardiac functional studies.~      Methods:~      The study plans to enroll thoracic cancer patients who will undergo local RT after complete~     staging. Patients will receive global risk scoring assessment (Framingham Risk Score, FRS),~     blood sampling for basic biochemistry, inflammatory biomarker, and myocardial perfusion image~     (MPI) at the time points of before and after RT. The results of MPI will be analyzed in~     qualitative visual interpretation of perfusion patterns, and functional quantitative data for~     cardiac functional parameters as well. The patients will be regular followed-up in CV OPD,~     following clinical judgement and guideline. The association between baseline and follow-up~     MPI, biomarker and clinical presentation will be further investigated.~      Expected results:~      We will obtain myocardial perfusion visual qualitative data in patients who received~     locoregional RT, respectively. These results will help in the understanding of~     pathophysiology, clinical management and follow-up of suspected RT-related heart disease.~   "
126364|NCT01913483|"~     The primary objective of the study is to test whether anticoagulation with bivalirudin~     results in fewer major bleeding complications compared with unfractionated heparin (UFH) in~     participants undergoing peripheral endovascular interventions (PEI). The secondary objective~     is to test whether there were potential benefits from bivalirudin therapy on other clinically~     important events such as death, myocardial infarction (MI), stroke and/or transient ischemic~     attack (TIA), amputation, unplanned repeat revascularization (URV), and minor bleeding, as~     well as potential economic benefits that may result from improved clinical outcomes.~   "
126343|NCT01913756|"~     The purpose of this trial is to investigate the effect of dairy products on the so called~     metabolic syndrome. Metabolic syndrome is a cluster of risk factors, such as high blood~     pressure and high cholesterol, for the development of diabetes and heart disease.~     Participants will be randomly assigned to either eat a portion of a Norwegian traditional~     cheese which is high in protein and low in fat (group 1), or eat a slightly higher than~     normal intake of regular Gouda-type cheese (group 2), or to limit their intake of cheese~     (group 3).~      Dairy products are a significant source of bioactive peptides, small pieces of protein which~     may have an effect on our health. These effects may be antimicrobial, antioxidative, or blood~     pressure lowering. The traditional Norwegian cheese, Gamalost, which is naturally high in~     protein (50%) and low in fat (<1%), has been found to be particularly high in these bioactive~     peptides. Specifically, the cheese was found to have a very high ACE-inhibitory activity,~     meaning it has the potential to lower blood pressure without the use of pharmaceuticals.~      A pilot study was performed in May 2012. No intervention was given in this trial, but~     participants answered an extensive questionnaire about dietary habits and lifestyle. This~     trial found that the people who ate the most Gamalost had a slightly lower blood pressure~     than those that did not eat the cheese. Since that was just a point-in-time study with no~     intervention or control, the investigators are not able to say anything certain about cause~     and effect, which is why the investigators want to perform this larger controlled study.~      In total, the investigators aim to recruit 300 people to participate in this trial, i.e. 100~     in each group. The participants will be randomly placed in one of the groups and they will~     have to do the intervention for eight weeks. At inclusion, the investigators measure blood~     pressure, fasting blood glucose, weight, height, waist circumference, and the investigators~     draw a fasting blood sample to measure cholesterol. The same measurements will be repeated at~     the end of the eight weeks. At inclusion they will also fill out an extensive questionnaire~     about their diet and lifestyle. A shorter version of the same questionnaire will also be~     given at the end of the trial period.~      The overall goal of the study is to assess the effect of dairy products on the metabolic~     syndrome, but the main hypothesis is to assess whether a high intake of Gamalost can reduce~     blood pressure in a group of people.~   "
126344|NCT01913743|"~     Previous studies have shown that obese individuals exhibit greater reward-related brain~     activity in response to food cues than lean individuals and our group has shown that~     successful weight loss maintainers who were previously obese and now maintain a healthy~     weight have increased control-related activity when viewing food cues. These findings suggest~     key roles for both reward-related brain areas and inhibitory control regions in eating~     behavior. However, no studies to date have examined (a) whether the response to food cues~     (i.e., cue-reactivity) can be changed in obese individuals, (b) which strategies are most~     effective at altering brain response to food cues, or (c) the neural mechanisms that support~     such change.~      Given the omnipresent environmental cues to eat and the association between heightened~     reward-responsivity and obesity, it is critical to investigate ways to potentially alter food~     cue-reactivity in the obese. The most widely employed approach for behavioral weight loss~     treatment is Cognitive Behavioral Therapy (CBT), which incorporates strategies to control and~     change cognitions (e.g., avoid desire to eat tempting foods by focusing on something else).~     This approach is sometimes described as change- focused because modifying negative thoughts~     is assumed to thereby change associated maladaptive emotions and behaviors. Alternatively,~     emerging evidence suggests Acceptance and Commitment Therapy (ACT), which teaches~     participants to recognize and accept their cravings as feelings that need not be acted upon,~     may also be effective in treating obesity. A third strategy often employed in smoking~     cessation and substance abuse treatment is to focus on the long-term consequences of~     behaviors, however this form of treatment is not typically used in behavioral weight loss~     therapy. Thus although each approach is potentially effective, these treatment approaches~     differ greatly in the cognitive strategies they employ.~      The primary aim of the proposed research is to compare a cognitive strategy used in CBT~     (ʻCHANGEʼ), a cognitive strategy emphasized in ACT (ʻACCEPTʼ), and a cognitive strategy used~     in smoking cessation (ʻLATERʼ) relative to a control condition (ʻNOWʼ), in their~     effectiveness in altering reward and inhibitory control responses to food cues among obese~     individuals.~   "
126345|NCT01913730|"~     This is a multicenter, randomized, open label study designed to evaluate the efficacy and~     safety of prolonged treatment with bortezomib twice monthly and dexamethasone after a salvage~     treatment containing bortezomib for relapsed or refractory multiple myeloma patients.~   "
126346|NCT01913717|"~     The present research project aims to improve the current treatment for prostate-confined~     tumor, evaluating the safety and feasibility of a very short hypofractionated radiotherapy~     schedule administered with one of the best available dose delivery systems. The study will~     include 2 sub-studies (in-silica and clinical study) and 4 tasks.~   "
126347|NCT01913704|"~     The purpose of this study is to determine the effectiveness of the NatroxTM Topical Oxygen~     device versus a placebo in patients with non-healing leg ulceration in conjunction with~     standard best practice.~   "
126348|NCT01913691|"~     Background:~      - Ipilimumab is a drug used to treat melanoma that cannot be treated surgically. It targets a~     molecule found on T-cells in the human immune system. Blocking these molecules on the T-cells~     might allow the cells to help destroy melanoma cells more effectively. This drug has also~     been studied in other cancers such as prostate cancer and lung cancer, but not yet in Merkel~     cell carcinoma (MCC). Researchers think therapy like ipilimumab that enhances the immune~     system may be effective against MCC. They want to study how safe the drug is and its effect~     on the immune system and tumors.~      Objectives:~      - To determine the number of subjects with MCC who take the study drug that remain alive 12~     months later.~      Eligibility:~      - Adults 18 years and older who have metastatic MCC.~      Design:~        -  Participants will be screened with a medical history and physical exam.~        -  Participants will receive the study drug 4 times, one dose every 21 days. After the 4~          visits, participants will receive a maintenance dose of the drug every 12 weeks until~          the drug is no longer beneficial.~        -  They will receive the drug through a plastic tube usually inserted in a vein on the arm.~        -  It will take 90 minutes to give each dose.~        -  At all visits, participants will be screened with a medical history, physical exam, and~          blood tests. Any tumors on their skin will be measured and photographed.~        -  Every 12 weeks during the study and maintenance period, participants will have a CT~          scan. Throughout the study and maintenance period, they will have blood and skin tests.~   "
126349|NCT01913678|"~     The objective of this study is to investigate whether intake of a diet with a high content of~     butyrate (from dairy fat) can affect blood FIAF concentration compared to a control diet.~     Further to examine whether high intake of inulin (a prebiotic) can increase the proportion of~     butyrate-producing bacteria in the gut and thereby affect blood FIAF concentration. In~     addition, the correlation between FIAF blood concentrations and resting energy expenditure,~     blood lipid profile and gut microbiota composition will be investigated.~      Furthermore, this study will investigate whether the source of FIAF can be determined. To~     this end, adipose tissue biopsies will be analyzed and an in vitro experiment with fecal~     water samples will be carried out.~      The study is a crossover randomized controlled trials with 3 arms. Each arm has a duration of~     3 weeks. 20 overweight/obese subjects will be enrolled into the study and randomized to the~     order of interventions. Before and after each intervention period, blood samples will be~     collected and the participants will have their resting metabolic rate measured. At the end of~     each intervention period, the participants will collect feces for 5 consecutive days. In~     addition, adipose tissue biopsies will be taken after each intervention period.~   "
126350|NCT01913665|"~     The aim of this study is to asses the effect of Bifidobacterium lactis and Inulin on~     functional constipation in children~   "
126387|NCT01913184|"~     To compare the continuous and sicontinuous delivery of drug with AKITA.~   "
126388|NCT01913171|"~     o determine effects of hula-hooping on android obesity, metabolic parameters and adipose~     tissue (AT) gene expression.~   "
126351|NCT01913652|"~     Soft tissue sarcomas (STS) are a rare group of malignant heterogenous tumors (> 50~     histological subtypes, including liposarcoma, the commonest subtype of STS) with distinct~     genetic, pathological and clinical profiles, and varying patterns of tumor spread. The~     optimal cytotoxic treatment for this group of patients remains uncertain. Single agents which~     are most effective include doxorubicin and ifosfamide, but objective response rates and~     progression-free survival times remain modest. There is clearly a need to improve treatment~     options for liposarcoma. Eribulin, a antimicrotubule agent that targets the protein tubulin~     in cells, interfering with cancer cell division and growth , has demonstrated activity in~     STS. Therefore, it is reasonable to explore whether other anti-microtubule agent like~     cabazitaxel have a role in STS. Cabazitaxel has been shown to be a relatively safe, effective~     and tolerated. This drug has been approved by FDA for prostate cancer. The main objective of~     this trial is to determine whether cabazitaxel demonstrate sufficient antitumor activity for~     liposarcoma.~   "
126352|NCT01913639|"~     The purpose of this study is to evaluate the effects, good and/or bad, of the drug~     regorafenib with chemotherapy regime (FOLFOX). This is a a Phase II trial that will study if~     this new treatment is effective and safe in patients with esophagus and stomach cancer.~   "
126353|NCT01913626|"~     assessing the Efficiency of cognitive group therapy for patients with subjective memory~     complains, using the neuropsychological computerized assessment of WebNeuro by Brain resource~     (BRC).~   "
126354|NCT01913613|"~     The objective of this clinical study is to evaluate the safety and performance of the IASD~     System II in the treatment of heart failure patients with elevated left atrial pressure, who~     remain symptomatic despite appropriate medical management.~   "
126355|NCT01913600|"~     Prospective, multi-center, non-randomized, single-arm, open-label study to assess the safety~     and efficacy of the Resolute Integrity Stent for the treatment of de novo lesions in native~     coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm in patients who~     receive extended length stents (34 mm or 38 mm) referred to as the Extended Length Study.~   "
126356|NCT01913587|"~     This study is to investigate the effectiveness of acupuncture for alleviating pain from~     Spinal Compression Fracture in Patients Treated with Nerve Block.~   "
126357|NCT01913574|"~     This study is to investigate the effectiveness of acupuncture for alleviating the upper~     abdominal pain of cancer patients~   "
126358|NCT01913561|"~     The Master Caution Garment is embedded with 10/13 textile dry electrodes that enable~     12/15-lead ECG.~      The electrodes are dry, textile ECG electrodes. The garment is designed to position the~     electrodes in the appropriate anatomical locations, without any special guidance. The dry~     electrodes are made from unique yarns with silver embedded into the garment using a~     proprietary technique developed by HealthWatch (HW)that obviates the need for skin~     preparation or the application of fluids. The garment can be connected to any standard ECG~     device available in the hospitals.~      The purpose of this study is to evaluate the safety and effectiveness of the Master Caution~     Garment for continuous monitoring of ECG signal compared to standard gel electrodes.~      The following endpoints will be evaluated in subjects participating in the study:~      Primary:~      Compare the quality of the ECG signal of HW textile electrodes compared to gel electrodes~     using standard ECG devices.~      Secondary:~      Compare the quality of the ECG signal of HW textile electrodes compared to gel electrodes~     when event is detected by the ECG devices.~   "
126359|NCT01913548|"~     The purpose of this study is to demonstrate that a sufficient number of iron-overloaded~     thalassemia (THAL), Sickle Cell Disease (SCD)and Diamond Blackfan Anemia (DBA) populations~     with similar duration of chronic transfusion, and age at start of transfusions would be~     available for a confirmatory study. The study will examine the hypothesis that a chronic~     inflammatory state in SCD leads to hepcidin- and cytokine-mediated iron withholding within~     the RES (reticuloendothelial system), lower plasma NTBI (non-transferrin bound iron) levels,~     less distribution of iron to the heart in SCD.~   "
126360|NCT01913535|"~     This study is looking at the efficacy, rapidity, safety, and tolerability of two doses of~     oral CERC-501 for treating patients with treatment resistant depression who are taking an~     antidepressant that is not working for them.~   "
126361|NCT01913522|"~     Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and is associated~     with reductions in quality of life, functional status, cardiac performance, and overall~     survival.1 Catheter ablation, which is centered on electrical isolation of triggering foci~     within the pulmonary veins (PVI) through circumferential lesions around PV ostia, has been~     shown to result in sustained improvements in quality of life, decreased hospitalizations and,~     potentially, improved survival.2-4 PVI can be accomplished by percutaneous catheter-based~     thermo-coagulation (burning) with radiofrequency (RF) energy delivery or alternatively by~     thermo-cooling (freezing) with a cryoballoon catheter.5 Cryothermal ablation with a~     cryoballoon catheter offers an efficacious means to achieve PVI that is safer than the~     established technique. Although cryoballoon ablation has been used in clinical practice for~     sometime, the optimal duration of cryoballoon ablation has not been determined. Moreover, the~     biophysics of cryo-lesion formation suggests that repeated short freezes~     (freeze-thaw-freeze cycles) may be more efficacious in achieving deep homogenous lesion~     when compared to prolonged freezing durations. This grant proposal is to verify if repeated~     short freezing cycles are more efficacious (i.e., fewer recurrence of AF), and safer, than~     the established standard of long, single freeze cycles.~   "
126362|NCT01913509|"~     The investigators anticipate this research will shed light on metric properties of outcome~     measures of pain and fatigue and the effects of the combined therapy for stroke patients. The~     overall findings will contribute to guide the choice of proper assessment tool and the~     development of effective rehabilitation programs.~   "
126363|NCT01913496|"~     The study is planned for people who would like to reduce or maintain their weight and keep a~     healthy life style .After signing an informed consent, participants will be divided randomly~     into two groups :control group and an intervention group that will get the application~     (eBalance ). Participants will be followed for 12 weeks.~   "
126389|NCT01913158|"~     The primary objective of this study is to determine the safety and efficacy of G&W~     Laboratories' Anucort HC TM (Hydrocortisone Acetate) 25mg Rectal Suppositories in subjects~     with internal hemorrhoidal symptoms.~   "
126365|NCT01913470|"~     Non-alcoholic fatty liver disease (NAFLD) is the most common liver disease among children and~     is closely associated with obesity and the metabolic syndrome. NAFLD increases risk of~     mortality and natural history studies of adults show that NAFLD is an independent risk factor~     for cardiovascular disease. Pediatric NAFLD is particularly concerning from a public health~     standpoint, as it represents an early and possibly more aggressive form of the disease.~     Currently there is no effective treatment for pediatric NAFLD.~      Losartan is an orally-administered angiotensin II receptor antagonist which is currently on~     the market to treat high blood pressure. The renin-angiotensin-aldosterone (RAA) system has~     been shown to be important in many disease states including renal disease, cardiovascular~     disease, and NAFLD. Angiotensin antagonists are a class of medications that has been proposed~     as a novel treatment of NAFLD in part because they would treat both the factors increasing~     cardiovascular (CVD) risks as well as potentially improve steatosis, fibrosis and hepatic~     inflammation.~      This study is a randomized, double-blinded, placebo-controlled pilot study to evaluate~     whether 8 weeks of Losartan will decrease inflammatory markers among children ages 12-19 with~     a current diagnosis of NAFLD. Efficacy will be assessed by improvement in alanine~     aminotransferase (ALT) from baseline. Secondary endpoints will include aspartate~     aminotransferase (AST), cytokeratin 18 levels, and fasting triglyceride levels among others.~     Safety will be assessed by the recording of adverse events, clinical laboratory parameters,~     vital signs and physical examinations.~   "
126366|NCT01913457|"~     Recently it has been shown that clear reproducible Doppler signals can be recorded from the~     lung parenchyma by means of a pulsed Doppler ultrasound system incorporating a special signal~     processing package parametric Doppler, TPD, EchoSense Ltd., Haifa, Israel). These lung~     Doppler signals (LDS) are in full synchrony with the cardiac cycle and can be obtained from~     the lungs, including areas remote from the heart and main pulmonary vessels. The LDS waves~     typically have peak velocities of up to 30 cm/s and are of relatively high power, making it~     possible to detect them despite the aforementioned attenuation by the air in the lungs. The~     LDS are thought to represent the radial wall movement of small pulmonary blood vessels,~     caused by pressure pulse waves of cardiac origin which propagate throughout the lung~     vasculature. The LDS may contain information of significant diagnostic and physiological~     value regarding the pulmonary parenchyma and vasculature, as well as the cardio-vascular~     system in general.~      Pulmonary arterial hypertension (PAH) is a condition characterized by reshaping of the small~     pulmonary arteries with increase in pulmonary vascular resistance, leading gradually to~     right-sided cardiac failure. A trans-thoracic echocardiograph (TTE) is a test classically~     undertaken in order to screen for pulmonary hypertension. However, the systolic pulmonary~     artery pressure (SPAP) values thereby obtained are often imprecise and depend upon the~     expertise of the individual carrying out the test. Therefore, the pulmonary arterial pressure~     and cardiac output values have to be ascertained with a right-sided cardiac catheterization,~     which is considered the gold-standard, but is invasive.~      In a pilot study of adult PAH patients (unpublished), lung Doppler signals have been shown to~     have the potential to diagnose pulmonary hypertension in two different ways: First, by~     measuring the degree of attenuation of the LDS during acute pressure rise in the chest cavity~     (i.e. during Valsalva maneuver). Second, by detecting differences between the LDS in patients~     with PAH and control subjects.~      One of the objectives of the present study is to evaluate the lung Doppler signals in~     pediatric patients of various age groups, with and without pulmonary vascular disease. The~     second objective of the study is to verify previous findings of abnormal lung Doppler signals~     in adult patients with pulmonary hypertension.~   "
126367|NCT01913444|"~     Maintenance of adequate anticoagulation or blood thinning is of critical importance when~     patients are placed on extracorporeal life support, such as extracorporeal membrane~     oxygenation (ECMO). During ECMO, a patient's entire blood volume is constantly exposed to the~     artificial surfaces of the ECMO circuit. This exposure activates the clotting cascade, and~     not only is the circuit at risk for clot formation, but the patient is also at risk for~     clotting within the body. Hence anticoagulation is vital in allowing the ECMO circuit to~     support a patient for an extended period of time. Anticoagulation on ECMO is achieved~     primarily by the use of a blood thinning agent called heparin. Heparin's main mechanism of~     action is to activate an enzyme called antithrombin III (AT III). AT III deficiency has been~     shown to be a common finding in pediatric patients requiring ECMO. This deficiency may then~     result in ineffective blood thinning by heparin. The purpose of this study is to determine~     how a neonate on ECMO, processes and eliminates a medication called ATryn® from their body.~     ATryn® is a form ATIII that is made from goat's milk. This will ultimately aid in~     establishing standardized dosing for the use of ATryn® in this patient population.~   "
126368|NCT01913431|"~     This is a multicenter, double blind, active-controlled, randomized, parallel group study to~     demonstrate the anti-viral activity and safety of Baracle Tab. and Baraclude Tab. for~     patients with HBeAg Chronic Hepatitis B. The subject will receive two tablets daily for 48~     days.~   "
126369|NCT01913418|"~     The purpose of this study is to evaluate the efficacy of Suan-Zao-Ren Tang in improving sleep~     quality, anxiety, depression, and heroin craving among methadone-maintained persons with~     sleep complaints.~   "
126370|NCT01913405|"~     The purpose of the study is to evaluate the efficacy and safety of BAX 855 in severe~     hemophilia A previously treated (PTP) males, 12 to 65 years of age who are undergoing~     elective surgical or other invasive procedures.~   "
126371|NCT01913392|"~     A prospective clinical trial will study the effects of laparoscopic sleeve gastrectomy in the~     potential renal transplant candidate who is denied acceptance due mainly to the morbid~     obesity.~   "
126372|NCT01913379|"~     A study to assess possible drug-drug interactions between MDV3100 and gemfibrozil and MDV3100~     and Itraconazole.~   "
126373|NCT01913366|"~     Dr. Brooke Hollister, Ph.D. from the department of Social and Behavioral Sciences at the~     University of California, San Francisco is conducting a study comparing two types of~     interventions for treating depression in rural older adults.~   "
126374|NCT01913353|"~     To demonstrate the efficacy of MVA-BN® by showing that vaccination prior to administration of~     ACAM2000® results in an attenuated take.~   "
126375|NCT01913340|"~     Hypoxic-ischemic encephalopathy (HIE), a condition of reduced blood and oxygen flow to a~     baby's brain near the time of birth, may cause death or neurologic disability. Cooling~     therapy (hypothermia) provides some protection, but about half of affected infants still have~     a poor outcome. This clinical trial will determine if the drug erythropoietin, given with~     hypothermia, is safe to use as a treatment that may further reduce the risk of neurologic~     deficits after HIE.~   "
126376|NCT01913327|"~     The purpose of the study is to determine whether two commonly-prescribed antipsychotic~     medications (aripiprazole and risperidone) have different effects on brain function and~     cognition in schizophrenia patients.~   "
126390|NCT01913145|"~     This is a study to evaluate the safety and effectiveness of Micro-Serum/Micro-Blood (finger~     Stick) Specimen Collection as compared to samples obtained by standard venipuncture (blood~     taken from the arm vein).~   "
126377|NCT01913314|"~     This type of study is called a radiolabeled study. For this study, LY2835219 (study drug) has~     been specially prepared to contain radiolabeled carbon [14C]. [14C] is a naturally occurring~     radioactive form of the element carbon. This study will help understand how the drug appears~     in the blood, urine, and stool after it is administered.~      In addition, this study will also evaluate the safety and tolerability of a single dose of~     LY2835219 when given to healthy participants. Information about any side effects that may~     occur will also be collected.~      This study will last about 3 weeks for each participant, not including screening.~   "
126378|NCT01913301|"~     The purpose of the study is to gather information regarding the safety and effectiveness of~     an investigational drug called Alagebrium when used treating Heart Failure in relation to~     exercise tolerance after 6 months in the trial.~   "
126379|NCT01913288|"~     The purpose of this RCT is to learn more about how sounds that we experience in the womb can~     affect early development in premature infants. The investigators are specifically interested~     determining whether and what types of maternal sensory stimulation can influence physical~     growth, brain maturation, respiratory stability and early vocalization during postnatal~     development. The investigators hypothesize that daily exposure to biological maternal sounds,~     such as mother's voice and heartbeat, will improve both short-term and long-term~     developmental in premature infants and will increase their potential to grow into healthy~     children.~   "
126380|NCT01913275|"~     Periampullary carcinoma and carcinoma head of pancreas are common causes of obstruction at~     the lower end of the common bile duct. Whenever possible, surgical resection in the form of~     Whipple Pancreaticoduodenectomy (WPD) is the treatment of choice. However, this operation is~     associated with a substantial postoperative morbidity and mortality. With advances in~     surgical techniques and postoperative care there has been a decrease in the operative~     mortality. However, the postoperative morbidity remains high varying between 5%-64%. Of the~     various risk factors, the degree of jaundice as indicated by the serum bilirubin levels has~     been associated with an increased risk of complications. Preoperative biliary drainage has~     been tried to decrease the serum bilirubin levels and consequently decrease postoperative~     morbidity and mortality. Internal biliary drainage can be achieved by surgical~     cholecystojejunostomy or endoscopic bile duct stenting. Endoscopic stenting can be done as a~     day care procedure under conscious sedation, but involves insertion of a foreign body~     (stent), which results in introduction of bacteria into the bile and problems of~     postoperative infection. Also, endoscopic stenting before surgery may result in difficulty in~     dissecting around the common bile duct during the surgical procedure. While the surgical~     bilioenteric bypass has the advantage that no foreign body is inserted into the biliary tree~     and hence the likelihood of sepsis is low, it requires anesthesia and involves a surgical~     incision.~      There is no study comparing the outcomes of preoperative endoscopic and surgical drainage in~     patients undergoing pancraticoduodenectomy. We plan to compare the outcomes of preoperative~     endoscopic biliary drainage with surgical drainage in patients undergoing~     pancreaticoduodenectomy.~   "
126381|NCT01913262|"~     This is an observational registry intended to track depression scores of patients over time~     in treatment.~   "
126382|NCT01913249|"~     The aim of this study is to compare short term (3 week) with long term (6 months) treatment~     with seton prior to LIFT surgery. The main end-points are recurrence rates and complication~     rates after surgery.~   "
126383|NCT01913236|"~     Background The prevalence of depression is high and the elderly have an increased risk of~     developing a chronic course. International data suggest that depression in the elderly is~     under-recognised, the latency before clinicians provide a treatment plan is longer, and~     elderly patients with depression are not offered psychotherapy to the same degree as younger~     patients. Although recommendations for the treatment of elderly patients with depression~     exist, health care professionals adhere to these recommendations to a limited degree only.~     Investigators conducted a systematic review to identify recommendations for managing~     depression in the elderly and prioritised six recommendations. Investigators identified and~     prioritised determinants of practice related to implementation of these recommendations in~     primary care, and subsequently discussed and prioritised interventions to address the~     identified determinants. The objective of this study is to evaluate the effectiveness of~     these tailored implementation interventions to implement six recommendations for the~     management of elderly patients with depression in primary care.~      Methods/design Investigators will conduct a pragmatic cluster randomised trial comparing~     implementation of the six recommendations using tailored interventions with usual care.~     Investigators will randomize 80 municipalities into one of two groups: an intervention group,~     to which investigators will deliver tailored interventions to implement the six~     recommendations, and a control group, to which investigators will not deliver any~     intervention. Investigators will randomise municipalities rather than patients, individual~     clinicians or practices because we will deliver the intervention for the first three~     recommendations at the municipal level and investigators want to minimise the risk of~     contamination across practices for the other three recommendations. The primary outcome is~     the proportion of general practitioners' behaviours which are consistent with the~     recommendations.~      Discussion This trial will investigate whether a tailored implementation approach is an~     effective strategy to improve collaborative care in the municipalities and health care~     professionals' practice towards elderly patients with depression in primary care. The~     effectiveness evaluation described in this protocol will be accompanied with a process~     evaluation exploring why and how the interventions were effective or ineffective.~   "
126384|NCT01913223|"~     ESD (Endoscopic Sub-mucosal Dissection)is the first-intent method to treat superficial~     neoplasms of the digestive tract at it allows an en-bloc R0 resection. Following marking of~     the lesion margins, ESD comprises 3 steps: 1) liquid injection into the sub-mucosal space 2)~     circumferential (complete or partial) incision and 3) dissection of the submucosa. Several~     tools are necessary to perform ESD with the standard technique. Development of water jet with~     bi functional (injection and cutting) catheter allows time and significant reduction of~     perforation risk (due to multiple changes of instruments). For this purpose, Nestis~     introduced the Enki 2 pulsed jet technology with high pressure system to inject efficiently~     and at any time viscous solutions in direct viewing and retroflexion. Preliminary pig studies~     indicate that injection of glycerol, hyaluronate and hydroxyethlstarch with Enki 2 are~     possible. In addition, preclinical studies on living pig colon models using saline solutions~     have demonstrated that perforation rates and operating times are significantly reduced~     compared to a standard electrosurgical knife. The present clinical study is being performed~     to confirm this system capability to perform ESD in humans.~   "
126385|NCT01913210|"~     To determine the effect of ginseng on blood pressure control.~   "
126386|NCT01913197|"~     In standard prostate brachytherapy treatment, the seeds are placed throughout the prostate to~     treat the entire gland. This is done because, in the past, it was impossible to know where~     the cancer was located within the prostate. Multiparametric magnetic resonance imaging (MRI)~     can identify tumor(s) with a high degree of accuracy. This trial will assess whether using~     MRI to guide prostate brachytherapy can result in less chronic toxicity by allowing lower~     doses to be delivered to the regions of the prostate without tumor while simultaneously~     allowing higher doses to the tumor. Subjects enrolled in this study will then be followed~     over two years and evaluated for toxicity. In addition, after two years they will undergo an~     MRI and a biopsy to assess the cancer control rate of the treatment.~   "
126391|NCT01913132|"~     The wound infection rate in the groin after vascular surgery has been denoted to be high~     since the wound surveillance register started in 2005. The current wound infection rate based~     on a validation study was 22.9% (24/105 patients with groin incision(s) between 1 March to 30~     June in 2012). The Deep/superficial infection ratio was 7/17. To prove that PICO (negative~     wound pressure therapy) reduces the wound infection rate with ½ standard deviation, 90% power~     at the 5% significance level, inclusion of 160 patients, 80 patients in the PICO Group and~     the standard dressing group are needed.~   "
126392|NCT01913119|"~     Extranodal NK/T-cell lymphoma is a rare disease entity with aggressive clinical course and~     poor prognosis. Currently, there is no treatment option for relapsed or refractory extranodal~     NK/T-cell lymphoma. Romidepsin is a histone deacetylase inhibitor which was approved for~     cutaneous T-cell lymphoma. A recent phase II study of romidepsin for relapsed/refractory~     peripheral T-cell lymphoma reported an overall response rate of 38% (95% confidence interval~     24%-53%). The median duration of overall response was 8.9 months. Considering the median~     number of previous treatments in these patients was three (range 1-11), romidepsin has single~     agent activity against relapsed/refractory T-cell lymphoma. Thus, if the single agent~     activity of romidepsin is demonstrated, it could be a therapeutic agent for combination with~     salvage treatment.~   "
126393|NCT01913106|"~     The purpose of this study is to conduct a Phase I - II clinical trial to extend preclinical~     studies involving in situ HSV-tk + Valacyclovir gene therapy in combination with~     brachytherapy for recurrent prostate cancer. This will provide a novel therapeutic approach~     to prostate cancer and hopefully impact on the development of metastatic disease and the~     control of preexisting metastasis.~   "
126394|NCT01913093|"~     To find possible therapeutic targets to help prevent long-term brain and behavioural side~     effects in survivors of childhood leukemia that may have been caused by chemotherapy~     (Treatment-Related late Adverse Neuro-Cognitive Effects: TRANCE). The study hypothesis is~     that genetic variations of the elements in the folate-related cycles and methotrexate~     disposition networks are associated with the TRANCE phenotype of childhood leukemia~     survivors.~   "
126395|NCT01913080|"~     The goal of the present study is to determine if a health management tool improves~     self-efficacy, satisfaction with the doctor's visit, and agreement of the statement How~     satisfied are you that your concerns were addressed during your clinic visit today over~     time.~   "
126396|NCT01913067|"~     A phase II trial evaluating Cabazitaxel in patients with brain metastasis secondary to breast~     and non-small-cell lung cancer (NSCLC).~      OBJECTIVES:~      Primary:~      The purpose of this study is to determine if cabazitaxel can induce a reduction in the size~     brain metastasis in metastatic HER2-negative breast cancer and NSCLC with brain metastasis~     who were not previously treated with whole brain irradiation or require immediate brain~     irradiation.~      Secondary:~        -  To determine the effect of cabazitaxel on the time to initiating whole brain irradiation~          or radiosurgery~        -  To determine the effect of cabazitaxel on the time to developing neurological symptoms~        -  To determine the effect of cabazitaxel on the time to disease progression in the brain~        -  To determine the effect of cabazitaxel on the time to disease progression outside the~          brain. This will be evaluated separately for the breast and NSCLC cohorts To determine~          the objective extra-cranial response (if applicable). This will be evaluated separately~          in the breast and NSCLC cohorts~        -  To determine the safety of cabazitaxel~   "
126397|NCT01913054|"~     Gastroscopy, as a conventional examination for gastrointestinal tract disease, plays a very~     important role especially in early diagnosis and differential diagnosis of esophageal and~     gastric carcinoma. However, conventional gastroscopy is associated with several adverse~     effects (including throat discomfort, breath-holding, nausea, vomiting, laryngeal spasm and~     increased heart rate) due to which some patients are intolerant to this examination or even~     refuse the procedure due to fear of these effects. Recently, painless gastroscopy has been~     applied increasingly widely in outpatients to meet the increasing needs for comfortable~     medical care.~      Painless gastroscopy is commonly performed under general anesthesia without establishing an~     artificial airway. This is associated with an even higher anesthetic risk than general~     anesthesia in the operating room due to more basic patient monitoring and life-supporting~     equipment, only one anesthetist to perform anesthesia, fatigue in anesthesia, the requirement~     for a high turnover rate, as well as limited understanding of a patient's condition.~     Therefore, the availability of sedatives and analgesics which can provide rapid onset,~     sufficient sedation and analgesia, a short recovery time and less adverse effects are the~     premise of performing painless gastroscopy. Currently, combined intravenous anesthesia with~     fentanyl and propofol, commonly used in the clinic, is still associated with a long duration~     of action, hypotension in some patients and prolonged recovery. Etomidate has been~     increasingly utilized for in-clinic diagnosis and treatment for procedures such as painless~     coloscopy and early induced abortion due to its rapid onset, rapid metabolism and minimal~     impact on the circulatory and respiratory systems. However, no study on combined intravenous~     anesthesia with fentanyl and etomidate for painless gastroscopy had previously been reported.~     The main purpose of this study is to explore the efficacy and safety of combined intravenous~     anesthesia with fentanyl and etomidate for painless gastroscopy compared with the combination~     of fentanyl and propofol in middle aged and elderly patients, and to provide reliable~     evidence for the implementation and promotion of comfortable medical care.~   "
126398|NCT01913041|"~     -  The purpose of this study is to understand and grasp the incidence rate of hypothermia~          during perioperative period of elective operations under general anaesthesia in Beijing.~        -  The purpose of this study is to carry out a subgroup analysis on the survey data and~          explore the high-risk factors for the incidence of hypothermia.~   "
126399|NCT01913028|"~     The purpose of this study is to assess safety, tolerability, pharmacokinetics and~     immunogenicity of MEDI9929 following administration of single ascending doses in healthy male~     Japanese subjects.~   "
126400|NCT01913015|"~     This randomized pilot phase I trial studies the side effects of dietary fat levels and~     abiraterone acetate uptake in patients with metastatic hormone-resistant prostate cancer.~     Abiraterone acetate may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. Eating a low or high fat diet may increase the uptake of abiraterone~     acetate.~   "
126401|NCT01913002|"~     This Phase 1 study is to investigate the effects of higher doses of LX4211 (800 mg and 2000~     mg) do not differ from placebo in the mean change in QTcI from Baseline in healthy subjects.~   "
126402|NCT01912989|"~     The purpose of this study is to investigate if a brief, motivational interviewing~     intervention (NOURISH+MI) can improve retention and treatment adherence for parents enrolled~     in an intervention for their child's overweight (NOURISH+). The investigators hypothesize~     that children whose parents participate in NOURISH+MI will demonstrate lower attrition and~     greater adherence with NOURISH+, ultimately leading to greater treatment effects, compared~     with children whose parents are randomized to NOURISH+ or a control group.~   "
126565|NCT01910844|"~     Study assessing efficacy of a Cisplatine- Métronomic cyclophosphamide treatment in Patients~     with Metastatic Triple Negative breast Cancer Secondary Resistant to Anthracyclines and~     Taxanes.~   "
126404|NCT01912963|"~     In this study, the investigators are testing the effectiveness of the combination of~     eribulin, pertuzumab and trastuzumab to learn whether this combination of drugs works in~     treating advanced HER2-positive breast cancer that had received at least one prior treatment~     previously. At this point, the standard treatment for HER2-positive cancer that has~     progressed (grown) after a first treatment is chemotherapy combined with therapies that~     target the HER2 protein (e.g., trastuzumab or lapatinib).~      All of the medications that are being tested in this study are approved by the Food and Drug~     administration (FDA) for the treatment of metastatic breast cancer. However, the combination~     of these three medications in participants has not yet been tested. Eribulin is a~     chemotherapy agent that is approved for the treatment of metastatic breast cancer for women~     who have previously received at least two prior chemotherapeutic regimens for the treatment~     of their metastatic disease. Pertuzumab and trastuzumab are also both approved for the~     treatment of advanced HER2-positive breast cancer. Both agents help treat breast cancer by~     binding HER2 receptor. However, pertuzumab and trastuzumab bind to different parts of the~     HER2 receptor.~      The goal of this research study is to find out if adding pertuzumab, trastuzumab and eribulin~     is effective in treating women with metastatic, HER2-positive breast cancer. The~     Investigators, will also gather more information on the side effects of these treatments~      The investigators also plan to gather genetic information from participants' tumors~     (collected at biopsies). Cancers occur when the molecules that control normal cell growth~     (genes and proteins) are altered. Changes in the tumor genes and in the genes of normal cells~     are called alterations. Many of these alterations can be detected by directly examining~     cancer cells in a tumor or circulating in blood. Several alterations that occur repeatedly in~     certain types of cancers have already been identified. These discoveries have led to the~     development of new drugs that target those alterations. More remain to be discovered.~      Some of the alterations are found in genes. Genes are composed of DNA letters, which~     contain the instructions that tell the cells in our bodies how to grow and work. Genes make~     proteins which actually carry out the instructions in our cells.~      The investigator would like to use your DNA to look for alterations in the genes in cancer~     cells and blood cells using a technology called sequencing. Gene sequencing is a way of~     reading the DNA to identify errors in genes that may contribute to the behavior of cells.~     Some changes in genes occur only in cancer cells. Others occur in normal cells as well, in~     the genes that may have been passed from parent to child. This research study will examine~     both kinds of genes.~      One of the scientific goals of this research study is to perform gene sequencing (gene tests)~     on your cancer cells (obtained from biopsies or surgery) and normal tissues (usually blood).~     The results of the gene tests will be used to try to develop better ways to treat and prevent~     cancers. As part of this work, we may also learn things about the genes in your normal cells.~     However, because interpretation of these tests will require further study,the investigator~     will not disclose these results to participants who participate on this component of the~     study.~   "
126405|NCT01912950|"~     The purpose of this randomized, controlled, open-label pilot study is to evaluate the safety~     and efficacy of a novel intense pulsed light (IPL) device for removal of unwanted fine body~     hair.~      Subjects will have a designated treatment area on one forearm divided into four equal-size~     quadrants. One quadrant will serve as the un-treated control area and the other 3 quadrants~     will be treated with the Cutera Prowave LX IPL. Subjects will receive 3 IPL treatments,~     spaced 8 weeks apart, on the designated area and will be followed at 12-weeks post-final~     treatment.~   "
126406|NCT01912937|"~     To describe the pharmacokinetics of paclitaxel in the blood delivered from a paclitaxel~     coated percutaneous angioplasty balloon catheter as a result of treatment of de novo or~     restenotic lesion(s), occluded/stenotic or re-occluded/restenotic lesion(s).~   "
126407|NCT01912924|"~     A study for patients who have chronic postoperative pain who had knee replacement surgery. If~     qualified, a 14 day trial and an implantation of spinal cord stimulator for control of pain~     will be administered. This study will evaluate effectiveness of pain control. Subjects will~     be followed for one year post implantation.~   "
126408|NCT01912911|"~     The investigators goal in this study is to examine the feasibility and efficacy of AliveCor~     iphone case monitoring device in monitoring patients after AF ablation by comparing~     transmissions using Alive Cor with transmissions from a traditional transtelephonic monitor~     (TTM).~      A secondary goal is to assess the ease of use of AliveCor device compared to traditional TTM~     system from the patient's perspective~   "
126409|NCT01912898|"~     Lack in vitamin D reduces the absorption of calcium in the body; accelerates bone loss tnd~     may increase the risk of fractures due to osteoporosis. An algorithm that will allow~     immadiate and non -invasiv quanification of vitamin D levels will shorten the time of~     diagnosis; reduce lab costs and prevent hazards or discomfort to patient associated with a~     blood test.~      The goal of the study is therfore to develop a non invasive method for quanitifying vitamin D~     levels in the body using specroscopy.~      40 subgects will be recruited: 20 hospitalized patients in the endocrinology departmet,~     diagnosed with vitamin D deficiency. and 20 healthy subjects. Spectroscopy will be used with~     wisible lighy on the subject's skin and middle infrared (MIR) on the blood sample to find~     correlation with the chemical lab test results.~   "
126410|NCT01912885|"~     INTRODUCTION: Overactive bladder syndrome is defined by The International Continence Society~     as urgency, with or without incontinence, usually with increased urinary frequency and~     nocturia. It is difficult to estimate the prevalence of this syndrome because many patients~     do not seek medical help, despite considerable negative impact on quality of life. Lower~     urinary tract dysfunctions can be treated using electrical stimulation of the posterior~     tibial nerve. This therapy is conservative, effective, inexpensive and promotes high adhesion~     to treatment. It has good results, decreasing symptoms of urgency, urge-incontinence, urinary~     frequency and nocturia . Due to lack of consensus on the parameters of this technique,~     further research is necessary. OBJECTIVE: To compare the effectiveness of protocols for the~     electrical stimulation of the posterior tibial nerve for treatment of non-neurogenic~     overactive bladder. METHODS: The study was a blind randomized clinical trial. The study will~     accept up to 145 women with overactive bladder diagnosis for at least six months prior to the~     beginning of the study. The subjects will be divided into five groups: group 1 (placebo~     group), group 2 (electrical stimulation of one leg once a week), group 3 (electrical~     stimulation of one leg twice a week), group 4 (electrical stimulation of two legs one a week)~     and group 5 (electrical stimulation of two legs twice a week). Physical evaluation will be~     done at the beginning and at the end of the treatment. Evaluation will be done using the King~     s Health Questionnaire, the International Consultation Incontinence Questionnaire - Short~     Form, the Overactive Bladder Questionnaire, a three day urinary diary and a table for~     follow-up treatment.~   "
126411|NCT01912872|"~     To assess efficacy and safety of omalizumab treatment during 12 months in order to reduce the~     use of inhaled corticosteroid (ICS) in pediatric and adult patients with severe IgE-mediated~     asthma inadequately controlled with high doses of corticosteroids.~   "
126412|NCT01912859|"~     The purpose of Next Steps pilot intervention is to develop and test a new program designed to~     help low-income multiethnic families with overweight or obese children achieve long-term~     maintenance of healthful behaviors following completion of Hennepin County Medical Center's~     (HCMC) 16-week intensive obesity management course (Taking Steps Together (TST)).~   "
126413|NCT01912846|"~     The purpose of this 5-year interventional study is to design, implement, and evaluate the~     effectiveness of an intervention aimed at facilitating prognosis communication and~     end-of-life care decision-making to increase the extent of congruence between the patient's~     preferred and actual EOL care received and patients' and family caregivers' QOL and~     psychological well-being, reduce futile aggressive healthcare resources utilization at~     end-of-life, and facilitate bereavement adjustment.~   "
126414|NCT01912833|"~     The purpose of the funded study is to determine a) examine associations among OT levels,~     stress, trauma history, PPD, and lactation failure in the full 60-subject sample and assess~     whether there are differences between immigrant women and non-immigrant Latina women on these~     measures; b) quantify whether there is a correlation between ACTH, cortisol, and PPD and~     whether there are differences between immigrant and non-immigrant Latina women; and c) assess~     the feasibility of enrolling Latinas into a laboratory-based study that includes the~     collection of venous blood for measurement of oxytocin, ACTH, and cortisol. Sixty prenatal~     (34 to 37 weeks) Latinas (30 immigrants and 30 U.S.-born) who are between the ages of 18 and~     45 will be enrolled. Women with a singleton pregnancy who are Latina, who intend to~     breastfeed for more than 2 months, who have or do not have a history of depression, and who~     are willing to be followed for 8 weeks after delivery will be enrolled in the study. Latinas~     who report maternal or infant disorder that may interfere with breastfeeding; those who~     endorse substance use, and/or who have or have had a psychiatric disorder (e.g., psychosis or~     serious personality disorders) other than depression or anxiety will be excluded to minimize~     risk and confounds with the outcomes of interest.~   "
126415|NCT01912820|"~     This randomized pilot phase I trial will evaluate if quercetin enhances the uptake of green~     tea polyphenols in the prostate tissue of men taking green tea extract and undergoing radical~     prostatectomy. Side effects of green tea extract and quercetin in combination with green tea~     extract will also be evaluated. In preclinical studies, green tea polyphenols have anticancer~     and cancer preventative effects in a number of malignancies. Likewise, in preclinical studies~     quercetin was found to enhance the anticancer effects of green tea. This trial is designed to~     translate these findings forward in a short-term human intervention trial.~   "
126416|NCT01912807|"~     The aim of this study was to investigate the efficacy of intraoperative intravenous dextrose~     in preventing POV in pediatric population undergoing dental day surgery.~      Post-operative vomiting (POV) in children is a frequent complication. Studies using~     intravenous (IV) fluids containing dextrose in the perioperative period have shown~     improvement of POV in adults. Similar studies have not been done in children.~      Knowing that Intravenous (IV) fluids containing dextrose are safe and commonly used in the~     paediatric population, this intervention could potentially reduce the amount of rescue~     antiemetic medications and improve recovery in same-day surgery paediatric patients.~   "
126417|NCT01912794|"~     To maintain stable body balance in daily activities, the ability to respond to external~     perturbations is an essential factor. Such capacity is limited in pathological conditions,~     such as in stroke, in which postural control is impaired due to lesions to the central~     nervous system. Impairment to postural control increases body sway during upright posture and~     leads to augmented frequency of falls. In this sense, the identification of mechanisms~     involved in body balance disorders after stroke is particularly important in situations of~     postural perturbation. The purpose of this project is to evaluate reactive postural responses~     to unpredictable external perturbations, analyzing postural dysfunctions caused by lesion to~     different brain areas as a result of stroke, and test principles of dynamic body balance~     rehabilitation.~   "
126418|NCT01912781|"~     The purpose of this study is demonstrate substantial equivalence of an investigational~     contact lens disinfecting solution to a commercially available contact lens solution in gas~     permeable lens wearers.~   "
126419|NCT01912768|"~     The purpose of this study is demonstrate substantial equivalence of an investigational~     contact lens disinfecting solution to a commercially available contact lens solution in~     silicone hydrogel and soft contact lens wearers.~   "
126420|NCT01912755|"~     The aim of this study was to verify the effectiveness of an anesthetic called articaine for~     dental treatment, comparing it with an anesthetic commonly used in dental clinic: lidocaine.~     Two types of local anesthesia (oral injection) in accordance with the solution used were~     performed. For patients anesthetized with articaine, an injection of anesthesia close to the~     tooth to be treated was used. For the anesthetic lidocaine an injection on the cheek at the~     bottom of the mouth was made. Differences between both techniques are mainly regarding the~     area of numbness. In the injection with articaine only a small part of the lip and the tooth~     was anesthetized. With lidocaine injection, the lower region of the entire side of the tooth~     and half of the tongue on the same side was numbed. The treatment was electronic randomized~     and there was equal chance to one or another treatment. The investigators are studying this~     new form of anesthesia (near the tooth that was treated) to see if it can numb the tooth to~     an emergency treatment, if it really decreases the feeling of numbness and discomfort during~     the service. Patients receiving articaine were submitted to cone beam exam at no cost.~   "
126421|NCT01912742|"~     Obesity has become a global epidemic with huge public health implications. Although clinical~     significant weight loss (WL) can be achieved by a combination of diet and behavioral~     modification, strong metabolic adaptations, with increased appetite and suppressed energy~     expenditure, are activated, which compromise WL maintenance and increase the risk of relapse.~     The aim of this project is to investigate the potential role of WL rate in modulating such~     responses. More specifically, the investigators want to determine if a similar WL achieved~     rapidly vs slowly induce the same compensatory responses to weight reduction. A secondary aim~     is to assess if speed of weight loss can influence motivation. A large battery of assessments~     will be performed before and after weight reduction including body composition, resting~     metabolic rate, substrate oxidation, exercise efficiency, fasting and postprandial release of~     several appetite-regulating hormones, subjective feelings of hunger and fullness and~     motivation. This project can bring large practical benefits concerning the design of weight~     loss programs to minimize weight relapse.~   "
126422|NCT01912729|"~     The mission of this project is to develop novel systems of care that can provide efficacious,~     scalable, cost-effective, participant friendly behavioral intervention technologies (BITs)~     for the prevention of depression in adolescents. The investigators define BITs as~     interventions that use information and telecommunications technologies such as the internet,~     mobile or traditional phones, computers and/or other technologies to support and deliver~     psychological and behavioral interventions. Through usability testing, focus interviews, and~     field trials, investigators may modify the technologies and intervention based on immediate~     usage data.~   "
138716|NCT01751607|"~     This prospective study aims to examine the association of specific genetic variants (single~     nucleotide polymorphisms) located on chromosome 1, 4 and 16, with presence of non-pulmonary~     vein triggers (NPVT) as well as ablation-outcome in AF patients~   "
126423|NCT01912716|"~     It is now established that indomethacin, a non-steroidal anti-inflammatory drug, at a dose of~     100 mg, is effective in reducing the frequency and severity of pancreatitis (inflammation of~     the pancreas) after endoscopic retrograde cholangiopancreatography (ERCP) in high risk~     patients. However, the optimal dose required is not known. The purpose of this study is to~     determine whether a dose of 200 mg, administered as rectal suppositories, is more effective~     than the standard dose of 100 mg. An ERCP procedure is a scope procedure where a lighted tube~     with a camera is passed down the patient's throat and allows for evaluation of the bile duct~     and/or pancreatic duct. The most common side effect of this procedure is post-ERCP~     pancreatitis, or swelling of the pancreas. Some patients are at higher risk for this~     complication than others. Our hypothesis is to compare the efficacy of these two dose~     regimens (100 mg vs 200 mg) of prophylactic rectally-administered indomethacin on the~     frequency and severity of post-ERCP pancreatitis in high-risk patients.~   "
126424|NCT01912703|"~     It is well-known that preterm delivery can be accompanied by complications. One of these~     complications is Intraventricular Hemorrhage (IVH). There are four degrees of IVH, according~     to severity. It is known that IVH Grades 3-4 can cause severe neurodevelopmental outcomes,~     including cerebral palsy (CP), hemiplegia, lower motor and cognitive skills and social~     difficulties. It is not known whether IVH Grades I-II have any of these effects and the aim~     of this study is to determine whether they do have any neurodevelopmental outcomes.~   "
126425|NCT01912690|"~     The hypothesis of the study is that aerobic conditioning following acute heart attack will~     improve autonomic function and electrical stability of the heart.~   "
126426|NCT01912677|"~     This is a pragmatic, open-label, randomised control trial of three oral anti-hypertensive~     regimens for women with severe hypertension in pregnancy. Women presenting with severe~     hypertension in pregnancy in two hospitals in Nagpur, India will be randomised to one of~     three oral regimens: nifedipine, labetalol or methyldopa. This trial will compare the~     efficacy, safety and side effects of these three oral regimens for management of hypertension~     in pregnant women. The investigators hypothesize that nifedipine treatment of severe~     hypertensive parturient women is more effective than treatment with labetalol or methyldopa~     in controlling high blood pressure within six hours.~   "
126427|NCT01912651|"~     Antibiotics are sometimes prescribed to patients who have had reconstructive surgery of~     wounds on their face using skin grafts. But, it is not yet known whether antibiotics improve~     the healing of skin grafts and reduce the risk of infections after surgery in these patients.~     It is known that antibiotics, like all medications, have side-effects although these are~     rare. This research study is designed to show us whether antibiotics improve wound healing or~     not, so that we may determine if we should continue using antibiotics even if they have~     side-effects in some patients.~      Our hypothesis is that patients treated with post-operative, systemic antibiotics will~     demonstrate a statistically significant improvement in the survival of their facial full~     thickness skin grafts compared to patients who are not treated with systemic antibiotics.~   "
126428|NCT01912638|"~     The purpose of this prospective randomized study is to assess and compare the clinical~     efficacy and safety of primary trabeculectomy with Ologen® collagen implant and cohesive~     viscoelastic (Provisc®) - augmented trabeculectomy in patients with medically uncontrolled~     steroid induced glaucoma.~   "
126429|NCT01912625|"~     This phase I trial studies the side effects and the best dose of trametinib when given~     together with combination chemotherapy and radiation therapy in treating patients with stage~     III non-small cell lung cancer that cannot be removed by surgery. Trametinib may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth~     of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells. Giving~     trametinib, combination chemotherapy, and radiation therapy may be a better treatment for~     non-small cell lung cancer.~   "
126430|NCT01912612|"~     Early stage breast cancer is typically treated with surgery, chemotherapy, radiation therapy,~     and/or endocrine therapy. Following treatment, 25-60% of breast cancer survivors have~     reported chronic pain, which can be difficult to manage. Duloxetine is a serotonin~     norepinephrine reuptake inhibitor that is FDA approved for treatment of depression, anxiety,~     fibromyalgia, diabetic neuropathic pain, knee arthritis, and low back pain.~      Pilot data suggest that duloxetine is effective in management of endocrine therapy-associated~     musculoskeletal pain, and a randomized placebo controlled trial of duloxetine has~     demonstrated efficacy for treatment of chemotherapy-induced neuropathic pain. In this~     mechanistic study of duloxetine versus placebo, we will investigate the change in pain~     sensitivity with treatment in order to evaluate both why duloxetine is effective for~     management of pain for some patients, as well as predictors of who is likely to benefit from~     duloxetine. A total of 84 women with early stage breast cancer who have chronic pain~     following treatment, as well as 48 women who are pain free, will be enrolled. All subjects~     will undergo assessment of pain sensitivity and complete questionnaires. Subjects with pain~     will be treated with duloxetine for a total of 7 weeks, with pain sensitivity assessments~     before treatment and after 4 weeks of full-dose treatment.~   "
126431|NCT01912599|"~     Purpose: To study the feasibility of a larger study by determining the tolerability of~     measuring blood pressure (BP) and intraocular pressure (IOP) over 24 hours in an ambulatory~     fashion with automatic devices.~      Participants: 20 patients with moderate to severe normal tension glaucoma and 20~     non-glaucomatous patients.~      Procedures (methods): Both BP and IOP will be measured automatically in each participant in~     an ambulatory fashion during a 24-hour period. BP will be monitored using an appropriately~     sized cuff Oscar 2 (Suntech Medical, Morrisville, NC), which will be placed by a person~     trained in ambulatory BP monitoring devices. The device will be set up to automatically~     inflate every 30 minutes during the day and every hour during the night to measure and record~     the BP. IOP will be measured using Sensimed Triggerfish contact lens (Sensimed AG, Lausanne,~     Switzerland); the measurements will be taken and recorded every 10 minutes. The contact lens~     will be inserted by eye doctors (investigators). Both monitoring devices will be removed the~     following day.~   "
128301|NCT01888029|"~     The aim of this study is to investigate whether the anodal transcranial direct current~     stimulation (tDCS) over the primary motor cortex (M1) in patients with mild cognitive~     impairment (MCI) leads to an increase in cortical plasticity (change in motor evoked~     potentials (MEP) in mV).~   "
126432|NCT01912586|"~     Although the high prevalence of erectile dysfunction (ED) was detected among male patients~     after the treatment for colorectal cancer, published reports depicting the erectile~     dysfunction experience of patients with colorectal cancer ot underpin service development are~     insufficient. Furthermore,unlike patients with prostate cancer, men with colorectal cancer~     are not routinely offered information and treatment for erectile dysfunction.However,~     investigations on patients after surgery for prostate cancer could provide some potentially~     useful insights. The ability of sildenafil and vacuum erection device (VED) to aid in the~     return of erections after nerve-sparing radical prostatectomy has been established, which may~     benefit rectal cancer patients after surgery with ED.~      Laparoscopic surgery, although technically demanding and associated with a long learning~     curve, has the advantage of clear visualization for the smallest structures,including the~     autonomic nerves. Laparoscopic resection for rectal cancer could thus facilitate preservation~     of the pelvic autonomic nerves.~      This study aimed to identify whether early intervention is effective at reducing the rate of~     ED at 12 months.~   "
126433|NCT01912573|"~     The goal of this study is to determine if nasal naloxone is inferior to standard care for~     naloxone administration in a pre-hospital setting. Ambulance squads in Adams, Clermont, and~     Scioto counties in southern Ohio will be randomized to provide either standard care or nasal~     (IN) naloxone as the initial response to a suspected opioid overdose. Standard care includes~     administration of naloxone by intravenous (IV), intramuscular (IM) or intraosseus (IO)~     methods.~   "
126434|NCT01912560|"~     The purpose of this study is to determine the safety and efficacy of different doses of~     CAT-2003 in patients with hyperlipidemia when CAT-2003 is taken for 4 weeks. The study will~     evaluate effects of CAT-2003 on (1) fasting triglycerides and non-HDL-C in patients with~     moderate hypertriglyceridemia and (2) fasting LDL-C levels in combination with a statin in~     patients with hypercholesterolemia who are on a statin.~   "
126435|NCT01912547|"~     Surgery for malignant pleural mesothelioma is complex and prolonged, and may involve~     significant blood loss with considerable blood and product transfusion. Thromboelastography~     (TEG) is a global assay of coagulation that uses whole blood to produce a tracing that~     records kinetic changes in clot formation. This study aims provide a better understanding of~     the coagulation profile of these patients, and will form the basis of a TEG-based transfusion~     algorithm for future surgeries for mesothelioma.~   "
126436|NCT01912534|"~     The purpose of this trial is to determine whether treatment with valsartan will have~     beneficial effect in early hypertrophic cardiomyopathy (HCM) by assessing many domains that~     reflect myocardial structure, function and biochemistry.~   "
126437|NCT01912521|"~     This pilot study is a non-randomized controlled cohort study evaluating the impact of social~     network-based HIV education on antiretroviral therapy (ART) adherence, clinical outcomes,~     food security, social support, HIV knowledge, and risk behaviors among people living with~     HIV/AIDS, as well as members of their associated social support networks. The intervention,~     known as the Mfangano Health Net Microclinic Pilot Program, consists of a 6-month education~     program on HIV biology, interpersonal communication and community mobilization for both HIV~     positive individuals and their self-selected social network members selected irrespective of~     HIV status. Investigators hypothesize that participation in the microclinic program will~     improve ART adherence, cluster of differentiation 4 (CD4) count, social support, HIV~     knowledge and food insecurity and will reduce HIV-related stigma, as compared to participants~     in control communities.~   "
126438|NCT01912508|"~     Cervical length is a already known predictor for preterm labor. In this study the~     investigators want to examining the hypothesis that cervical curvature is also a predictor~     for preterm labor and that moderate transducer pressure influence cervical length.~      study population: 200 consecutive pregnant women between 14-34w, visiting in the ultrasound~     unit ether for routine screening or because of preterm labor.~      During their examination cervical length and curvature measurements will be taken. Another~     measurement will be taken after applying moderate cervical pressure.~      The investigators will compere cervical contour and pressure influence between groups and~     according to cervical length Demographic data will be taken at the time of recruitment and~     pregnancy outcome measures in a later telephone interview.~   "
126439|NCT01912495|"~     Prospective open label proof of concept feasibility interventional clinical trial in which 60~     acute HCV genotype 1 patients co-infected with HIV will receive 12 weeks of boceprevir in~     addition to Standard Of Care Peginterferon + Ribavirin if they show a Rapid Viral Responds at~     week 4.~      The primary hypothesis of this study is that the subset of patients with a Rapid Viral~     Responds after 4 weeks of triple therapy with boceprevir, peginterferon alpha-2b (P) and~     ribavirin (RVR4) can be successfully treated with a shorter 12-week triple therapy regimen.~   "
126440|NCT01912482|"~     The cardiorespiratory training can increase muscle strength ventilatory.~   "
126441|NCT01912469|"~     To investigate and compare the effects of Traumeel®S tablets versus placebo on exercise~     induced muscle damage and muscle soreness for 72 hours after strenuous eccentric exercise~     test on downhill treadmill.~   "
126442|NCT01912456|"~     The aim of this study is to assess the efficacy of C1-esterase inhibitor in preventing~     hereditary angioedema attacks when it is administered under the skin of subjects with~     hereditary angioedema. The safety of C1-esterase inhibitor will also be assessed. Each~     subject will enter a run-in period of up to 8-weeks. Subjects who complete the run-in period~     and who are eligible will then enter the treatment phase which comprises two sequential~     treatment periods. In the treatment phase, subjects will be randomized to one of four arms~     consisting of treatment with low- or higher-volume C1-esterase inhibitor in one treatment~     period and treatment with low- or higher-volume placebo in the other treatment period. The~     study will measure the number of hereditary angioedema attacks that subjects experience while~     receiving each treatment.~   "
126443|NCT01912443|"~     To assess the safety profile of bevacizumab in combination with chemotherapy for the~     treatment of metastatic colorectal cancer~   "
126457|NCT01912261|"~     The purpose of this research study is to examine how an oral iron supplement (Feramax®)~     influences fatigue during early postoperative recovery (at three months) among CABG patients~     and, the effects on recovery outcomes (e.g. quality of life, functional capacity, anemia, and~     medication adherence).~      It is hypothesized that CABG surgery patients receiving oral iron (Feramax®) 150mg orally~     (once a day therapy) will have a 15% reduction in POF (measured by the Identity Consequence~     Fatigue Scale (ICFS)), compared to patients receiving a placebo.~   "
126444|NCT01912430|"~     New payment methods such as Accountable Care Organization (ACO's) and medical homes~     facilitate are new models for providers to deliver cost effective, quality patient outcomes.~     Integrated Care Coaching (ICC) is a healthcare delivery model combining telephonic~     interventions with an intelligent information technology platform that offered validated~     protocols and patient outcomes tracking. Health Integrated, Inc. has developed a validated~     program of Integrated Care Coaching (ICC), which was branded as VitalCare, and implemented~     with over 7,000 members of the Scott and White Health Plan in Texas, would reduce healthcare~     costs/achieve a return on investment (ROI), improve clinical outcomes, and be satisfying for~     participants.~   "
126445|NCT01912417|"~     The aim of this study is to evaluate the effect of aerobic exercise during dialysis on the~     hemodialysis efficacy in the removal of small molecules measured by continues spend sampling~     of dialysate (liquid metabolites produced by the body which is disposed) technique.~   "
126446|NCT01912404|"~     The main purpose of the study is to test if taking a study drug called emricasan (also known~     as IDN-6556 and PF-03491390) will affect overall patient survival after one month of~     treatment.~   "
126447|NCT01912391|"~     Selegiline is superior to placebo in improving psychological and physical functioning in~     patients with Borderline Personality Disorder.~   "
126448|NCT01912378|"~     The study will investigate the effects of an intranasal administration of oxytocin (OT) to~     parents of children with autism spectrum disorders (ASD) on the quality of~     mother-father-child interactions. Physiological and behavioral measures of parent-child~     triadic interaction quality will be assessed.~      H1: Parents who receive OT will demonstrate greater parental engagement and nonverbal~     prosocial behaviors compared to parents who receive placebo.~      H2: Children with ASD whose parents receive OT will have increased nonverbal prosocial~     behaviors during the discussion and play tasks compared to children whose parents' receive~     placebo.~      H3: Parents who receive OT will demonstrate increased behavioral and physiological synchrony~     with their child during the discussion and play tasks compared to parents who receive placebo~     and their child.~   "
126449|NCT01912365|"~     Elbow fractures are very common in young children. Type I supracondylar fractures are stable~     fractures to the elbow that are treated conservatively across the world and typically heal~     very well without complications. There are several treatment options, including an above~     elbow cast or long arm splint. This study aims to determine if one treatment is no worse than~     the other in order to standardize the treatment of these fractures at our institution. The~     investigators hope to save families from extra hospital visits and reduce the amount of~     x-rays required for treatment of these fractures.~   "
126450|NCT01912352|"~     The aims of the current study are to examine gene-environment interactions associated with~     norepinephrine (NE) system genes (ADRA2A, SLC6A2) in ADHD, and to evaluate whether genetic~     changes in norepinephrine pathway are associated with differences in functional connectivity~     of white matter fiber tracts, as measured by diffusion tensor imaging (DTI). Furthermore,~     this study aims to examine neurobiological markers, such as intermediate neuroimaging~     phenotypes or neuropsychological endophenotypes associated with the pathophysiology of ADHD.~     Through evaluating drug responses and side effects with the associated measures of clinical,~     neuropsychological and neuroimaging characteristics, investigators would like to investigate~     predictors of treatment response associated with NE system genes in ADHD.~   "
126451|NCT01912339|"~     To evaluate the safety and efficacy of the Rezūm System and assess its effect on urinary~     symptoms secondary to benign prostatic hyperplasia (BPH).~   "
126452|NCT01912326|"~     Evaluation of dynamic Atrial Overdrive Stimulation using the AF Suppression Algorithm to~     prevent atrial tachyarrhythmias in patients with more than 2% Auto Mode Switch Episodes with~     optimized pacemaker programming.~      Hypothesis:~      Dynamic atrial Overdrive (AF Suppression) reduces AT/AF Burden by 30% as compared to~     programming DDDR-(60) without AF Suppression when all other parameters are optimized.~   "
126453|NCT01912313|"~     Rectal biopsies from IBS patients or healthy subjects will be taken.~      Biopsies will be used for:~        1. the isolation of submucosal plexus to perform: 1.1 live nerve recordings and Calcium~          imaging; 1.2 immunohistochemistry; 1.3 mRNA (Messenger ribonucleic acids) isolation and~          real time PCR (Polymerase chain reaction);~        2. culturing biopsies~      On the basis of these observations, the general aim of the study is to move a significant~     step forward in the current knowledge on human ENS (enteric nervous system) in IBS by~     establishing a live imaging method to record enteric nerves activity in small intestinal~     biopsies from humans. This development is unique in its kind as not other research groups~     have reported successful live recordings with calcium imaging in this preparation.~      In particular, the investigators aim:~        1. to develop and validate the technique to measure activity in human enteric nerves in the~          submucous plexus isolated from rectal biopsies from healthy subjects and IBS patients;~        2. to characterize this nerve activity in healthy subjects and IBS patients using both~          calcium imaging to evaluate the effect of different neuromodulators,~          immunohistochemistry and rtPCR to determine receptor expression levels and identify~          neurons and glial cells in the submucous ganglia;~        3. to investigate whether the biopsies of IBS patients secrete more modulators/cytokines~          compared to healthy subjects and their potential to activate neurons.~        4. to evaluate the influence of different food constituents (cow‟s milk, wheat, yeast,~          gluten and soy) on the local reaction of the rectal mucosa and evaluate mast cell~          activation/degranulation in biopsies of IBS patients compared to healthy subjects.~        5. To evaluate the amount of inflammatory mediators/metabolites in urine samples of IBS~          patients and healthy volunteers by the use of metabolic profiling~   "
126454|NCT01912300|"~     Sedentary behaviors have been shown to increase food consumption among youth and adults. The~     recent active video games devices have been suggested to compensate for the increased energy~     intake they induce by the increased energy expenditure they generate. To date no study has~     been conducted to question whether or not such modern sedentary activities induce energy~     consumption modification in youth. The aim of this work is to compare the impact of a passive~     video games vs. active video games vs. physical exercise in terms of subsequent energy intake~     and appetite feelings in normal weight and obese youth.~   "
126455|NCT01912287|"~     The purpose of this randomized study is to examine the comparative efficacy of yoga,~     cognitive behavioral therapy, and stress education, a previously employed control condition,~     for patients with Generalized Anxiety Disorder.~   "
126456|NCT01912274|"~     The purpose of this study is to determine the safety and effectiveness of pracinostat when~     combined with azacitadine for patients who are 65 years of age or older and have Acute~     Myelogenous Leukemia (AML)~   "
126458|NCT01912248|"~     Moderate and heavy strength training exercise and the acute blood pressure rise in cardiac~     patient, how high?~   "
128302|NCT01888016|"~     The purpose is to evaluate the effectiveness of fascial manipulation treatment in terms to~     reduce pain and improve physical functionality after rotator's cuff surgery. The technique~     involves deep friction manipulation of fascia's specific spots. Distant from surgical site.~   "
126459|NCT01912235|"~     Arginine synthesis in mammals is a complex process involving at least 8 enzymes and~     intracellular and interorgan transfer of substrates.~      The investigators have shown in our neonatal studies that there is no conversion of glutamate~     to arginine but proline label appears in ornithine, citrulline and arginine. It is clear~     therefore that arginine is synthesized in human neonates from proline.~      In adults the source of the carbon backbone is less clear.~   "
126460|NCT01912222|"~     This is a phase 1, 2-part, pharmacokinetic study in patients with advanced solid tumors or~     hematologic malignancies and varying degrees of liver dysfunction (normal function, moderate~     hepatic impairement or severe hepatic impairment) as defined by the National Cancer Institute~     (NCI) Organ Dysfunction Working Group.~   "
126461|NCT01912209|"~     The purpose of BEHHS is first to assess the baseline sub-clinical disease in a population of~     Baptist Health Employees who have Metabolic Syndrome, a known contributor to cardiovascular~     disease. Second, the investigators wish to encourage a healthy lifestyle through personalized~     nutrition and fitness advice, delivered as part of a web based program, which will in turn~     lead to increases in heart healthy behaviors such as increased consumption of heart healthy~     foods, increased exercise initiation, and more positive attitudes about health. To assess~     this, the investigators plan to randomize 200 employees with Metabolic Syndrome to either the~     new web-based diet and lifestyle program, or to care-as-usual, which is the currently offered~     MyWellnessAdvantage and WebMD websites. The investigators hypothesize that the web-based~     group will show greater improvements in physical health (such as weight loss, cholesterol~     reduction, etc.) as well as increased consumption of heart healthy foods, exercise~     initiation, and quality of sleep as measured by surveys administered at the 4,8, and 12 month~     follow-up appointments.~   "
126462|NCT01912196|"~     The purpose of this study is to determine the efficacy and safety of 800 mg MSI-195 in~     reducing symptoms of depression in Major Depressive Disorder (MDD)patients with inadequate~     response to current antidepressant therapy.~   "
126463|NCT01912183|"~     This is a pilot study to examine the feasibility of implementing an objective physical~     activity and sleep monitoring tool into a pediatric weight management program in conjunction~     with a personal health record (PHR) for children and their families. This feasibility study~     is intended to provide proof of concept in the incorporation of monitoring devices within the~     PHR for pediatric patients and their families. Additionally, the investigators will examine~     whether the PHR helps to empower pediatric patients, their families and the health care team~     to more effectively monitor the patient's behavior change. Participants will be randomized to~     receive, or not receive, augmented communication with the health care team between clinical~     in person visits.~   "
126464|NCT01912170|"~     This study is to examine the change of fasting insulin, glucose, insulin sensitivity and~     related traits in response to the 14 wk treatment of omega-3 fatty acids, including fish oil~     (n=25) and flaxseed oil(n=25), in Chinese gestational diabetic patients. Corn oil(n=25), rich~     in omega-6 fatty acids, will be selected as a controlled oil. The intervention will start~     from the third trimester of these pregnant women and finish at the 4wk after the birth of~     their children. The investigators hypothesize that omega-3 fatty acids could improve insulin~     sensitivity and glucose metabolism in these patients.~   "
126465|NCT01912157|"~     Handling of complex health situations (as defined by multimorbidity) in partnership:~     communication between romantic partners; subjective illness perception; coping with stressful~     experiences due to multimorbidity.~      Intervention : Expressive Writing about subjective illness perception vs. Writing about~     individual Time-Management Primary Endpoint: subjective Health (e.g. SF 12 questionnaire)~     Secondary Endpoints: Psychosocial Adjustments (Depression, somatic symptoms, quality of~     partnership and others)~   "
126466|NCT01912144|"~     Phenolic acids are naturally-occurring constituents of plant-derived foods and beverages and~     are characterised by a phenol ring in their structure. The phenolic compounds we are going to~     focus on in this study are the Chlorogenic acids (CGAs), a family of esters conjugates formed~     between a Hydroxycinnamic acid and quinic acid (1) and that show a strong antioxidant~     activity (2).~      HCAs represent about 50% of the total polyphenolic coumpounds intake in a typical UK diet (3)~     and for people who drink it, coffee is a/the major dietary source of/for HCAs (4). A few~     studies suggest protective effects for cardiovascular diseases (5), neurodegenerative~     diseases, type 2 diabetis and liver and kidneys cancer risk. However, many data in the field~     are obtained from in vitro and/or in animal, and it is difficult and dangerous to extrapolate~     between these and risk in humans of development or progression of particular health~     conditions, more human studies are therefore needed.~      We aim to compare people that metabolise the best CGAs from coffee to those that metabolise~     them the least well. This will be achieved by measuring the metabolites in urine. The effect~     of CGAs on the human body does not only depend on the amount ingested, but also on the~     quality of the metabolism, we therefore also want to determine which mechanisms are~     responsible for inter-individual variations in order to identify any link with health~     biomarkers, these including non-cellular inflammation and cardiovascular risk indicators.~      For this cohort study funded by the University of Leeds, approximately 60 healthy volunteers~     will be recruited at the School of Food Science & Nutrition. If they meet the selection~     criteria, participants will be asked to undergo a 36-hour wash-out period. During those 36~     hours, participants won't be allowed to drink coffee, they will be asked to follow a diet low~     in phenolic acids and keep a record of their meals. On the first day of the study, a single~     dose of coffee rich in antioxidants will be given to the participant and urine will be~     collected from that time until 36 hours after coffee consumption. Participants will be~     followed again after 5 to 6 weeks.~   "
126467|NCT01912131|"~     This study is being done to get individuals' feedback on advanced care planning and decision~     making.~      This study is divided into two parts (Part 1 and Part 2). The purpose of Part 1 is to survey~     people to find out what is important to people with advanced cancer (again, their values,~     such as their goals, concerns and sources of support). This has never been done before in the~     way the investigators are doing it, and that is why this is called a pilot study, which is~     where a new method or treatment is being created and evaluated.~      The purpose of Part 2 is to see if combining a medical options video with a short interview~     about values helps people with how they feel about their medical situation, and what they~     know about their medical options for their medical situation.~   "
126495|NCT01911754|"~     The purpose of this study is to obtain immunogenicity and safety data of an H5N1 pandemic~     influenza vaccine in a Japanese pediatric population aged 6 months to 17 years~   "
126496|NCT01911741|"~     A study to evaluate the bioavailability (BA) of a single oral dose of MDV3100 (enzalutamide)~     formulated as a solid spray dried tablet compared to oral liquid-filled capsules, and the~     safety and tolerability of oral formulations.~      Subjects are admitted to the clinic from days 1 to 5, followed by outpatient assessments up~     to Day 50. They return to the clinic for an end of study visit (ESV) 7-10 days after the last~     pharmacokinetic (PK) sampling or after early withdrawal.~   "
126468|NCT01912118|"~     Despite various efforts there is still the need for adequate monitoring of pain and~     nociception during anesthesia. In a previous protocol the investigators measured pain~     responses during anesthesia based on single end‐points, eg heart rate,blood pressure and~     pulse transit time. None of these parameters provided sufficient information regarding~     nociception. The investigators therefore want to further investigate this matter using a~     composite parameter, the Nociception Level or NoL. The NoL is a novel index that measures the~     magnitude of the autonomic response to painful stimuli. The NoL combines information from~     several physiological parameters, which represent different autonomic pathways. The~     multi‐parameter approach empowered with state‐of‐the‐art signal processing and machine~     learning techniques. In the current study the investigators will measure the NoL in ASA 1‐3~     patients undergoing elective surgery under general anesthesia. The investigators will measure~     NoL responses and the occurrence of patient movement upon the administration of a painful~     stimulus: Introduction of the laryngoscope, Insertion of the endotracheal tube, Insertion of~     the gastric tube, Insertion of the bladder catheter and Skin incision.~   "
126469|NCT01912105|"~     Cleaning the endotracheal tube with a specifically designed device results in lower amount of~     secretions at extubation, assessed by micro CT scan~   "
126470|NCT01912092|"~     The purpose of this study is to assess the efficacy of Askina® Calgitrol® Paste in reducing~     local infection in subjects treated for mildly infected Diabetic Foot Ulcers (DFU) with~     Askina® Calgitrol® Paste.~   "
126471|NCT01912066|"~     This is a phase IV clinical study to evaluate the preventive effectiveness of~     NSAID-Associated Gastroduodenal Injury. The study is consisted of multi-center, doubleblind,~     active-controlled, stratified randomized, parallel group. A tablet of DA9601, Cytotec (200ug~     of Misoprostol), Acrofen (100mg of Aceclofenac) will be assigned randomly to the subjects for~     four weeks.~   "
126472|NCT01912053|"~     The purpose of this study is to assess efficacy and tolerance of intra-hepatic administration~     of Yttrium 90-labelled microsphere (Theraspheres®, Nordion) in association with intravenous~     chemotherapy with Gemcitabin and Cisplatin for the treatment of intra-hepatic~     cholangiocarcinoma.~   "
126473|NCT01912040|"~     Assessing 123 Iodine MIBG produced locally for safety while being used in clinical practice~     to help in patient management decisions.~   "
126474|NCT01912027|"~     The open Latarjet techniques has benn considered as an effective treatment on anterior~     shoulder instability.Over the past decade there has been a shift from open to~     all-arthroscopic technique in many surgeries. The arthroscopic technique may result in less~     postoperative stiffness and faster rehabilitation. So we hypothesized that the arthroscopic~     Latarjet techniques would have better clinical and radiographic outcomes than the open~     Latarjet Techniques on anterior shoulder instability.~   "
126475|NCT01912014|"~     The purpose of this feasibility study is to develop and initially test a dialogue-based~     psychosocial intervention aimed at promoting coping and psychosocial wellbeing following an~     acute stroke. The intervention is carried out by primary care registered nurses or other~     appropriate health professionals. The intervention included persons with and without aphasia.~   "
126476|NCT01912001|"~     Home based renal replacement therapy (RRT), including peritoneal dialysis (PD) and home~     hemodialysis(HHD), offers enhanced quality of life and clinical advantages compared to~     conventional in-center hemodialysis. Patients with end stage renal disease, that is failure~     of the kidneys such that dialysis is required, are at high risk for adverse health events~     especially during a period of transition following a change in care settings. The~     investigators aim to implement a Home Dialysis Virtual Ward (HDVW) strategy of telephone~     follow-up, which is targeted to minimize gaps of care during transitions in care.~      The investigators aim to have clinicians follow patients by telephone if they meet one of the~     following four criteria;~        1. Discharge from hospital.~        2. Having an interventional procedure.~        3. Prescription of an antibiotic.~        4. Completion of Home Dialysis training.~      The major goal of this HDVW initiative is to provide appropriate and effective supports to~     medically complex patients in a targeted window of vulnerability.~   "
126477|NCT01911988|"~     The purpose of this study is to determine association between Peripheral Immune Cells(PIC)~     and recurrence in stage II/III colorectal cancer~   "
126478|NCT01911975|"~     Lacosamide is a functionalized amino acid with antinociceptive properties in inflammatory and~     neuropathic pain, and displays a unique mechanism: it enhances slow inactivation of Nav1.3,~     Nav1.7, and Nav1.8.~      Nav1.7 is expressed predominantly in nociceptive and sympathetic neurons. Gain-of-function~     mutations have been described in Nav1.7 that result in extreme pain disorders such as~     SCN9A-associated small fiber neuropathy. In the disease states genetically linked to a~     gain-of-function of Nav1.7, the sodium channel is mutated to increase the sodium influx~     resulting in a hyperexcitable sensory neuron, and a resultant sensation of pain.~      The objective of the study is to determine the efficacy and safety of lacosamide, a sodium~     channel blocker, in patients with pain due to SCN9A-associated small fiber neuropathy.~   "
126479|NCT01911962|"~     To evaluate the postoperative outcome of low medium-low rectal endometriosis: Natural orifice~     surgery VS transabdominal surgery.~   "
126480|NCT01911949|"~     Hip replacement surgery is one of the most common elective surgeries in Canada and with this~     surgery, there is considerable pain after the operation. By decreasing the amount of pain~     after surgery, the patients may be able to move and walk quicker, resulting in easier~     physiotherapy sessions, shorter hospital stays and may help to avoid adverse outcomes like~     nausea and vomiting and being overly sedated. By using ultrasound guided femoral nerve block,~     it may be an alternative for pain management with minimal side effects for patients having~     hip replacement surgery.~   "
126481|NCT01911936|"~     This study will evaluate safety and tolerability to estimate the MTDand/or recommended dose.~   "
126482|NCT01911923|"~     Atelectasis is common during and after general anesthesia. The investigators hypothesized~     that a ventilation strategy with a combination of 1) continuous positive airway pressure~     (CPAP) or positive end-expiratory pressure (PEEP) and 2) a reduced end-expiratory oxygen~     fraction (FETO2) before commencing mask ventilation with CPAP after extubation would reduce~     the area of postoperative atelectasis.~   "
126497|NCT01911728|"~     A drug-drug interaction study to investigate the potential pharmacokinetic interaction~     between MDV3100 and a cocktail of substrates for pioglitazone (CYP2C8 substrate), S-warfarin~     (CYP2C9 substrate), omeprazole (CYP2C19 substrate), and midazolam (CYP3A4 substrate).~   "
126483|NCT01911910|"~     Diseases of the heart and blood vessels, such as heart attacks and strokes, are very common~     and can lead to severe disability or death. Changes in the body leading to heart attacks and~     strokes usually develop over decades as a result of smoking, diet, and lack of exercise,~     obesity, diabetes and high blood pressure. Changes in lifestyle and diet can significantly~     reduce the risk of heart diseases. General Practitioners invite 40 to 74 year-olds who have~     no known heart disease to take part in the NHS Health Check, which measures each person's~     individual risk of developing a heart attack or stroke and encourages them in a face-to-face~     meeting to take part in programmes to help them to give up smoking, lose weight etc. where~     necessary. In this new clinical trial the investigators will test whether computer-tailored~     electronic (e)-coaching via email and the internet can help people make the necessary changes~     in their lifestyle to reduce the risk of heart attacks and strokes.~   "
126484|NCT01911897|"~     To evaluate the safety and performance of the MobiusHD system in subjects with resistant~     hypertension.~   "
126485|NCT01911884|"~     The principal objective is to assess the general health status and the sexual health status~     of women with Rokitansky syndrome having received a surgical or non surgical treatment.~      The secondary purpose is to assess the anatomical aspect and the quality of sexual life. To~     search a correlation between the anatomical result, the general and sexual quality of life.~     To compare the different techniques of medical follow-up in terms of anatomic results,~     general quality of life, sexual quality of life, complications and morbidities.~      To evaluate social inclusion of these women with their family situation, social and~     professional category and their job.~      At the same time, we propose an evaluation with a psychologist to study the impact of the~     announcement of the diagnosis. This impact study is conducted at a distance from diagnosis.~   "
126486|NCT01911871|"~     The investigators' primary objective is to study prevalences of myocardial iron overload,~     defined as a cardiac T2*< 20 ms, in 3 populations of multiply transfused patients, affected~     with thalassemia, sickle cell disease, and myelodysplasia.~   "
126487|NCT01911858|"~     The purpose of the study is to demonstrate that Askina® Calgitrol® Paste is safe to use on~     III degree burns by quantifying the concentration of silver in the blood during treatment and~     thus to show that the amount of silver absorbed will be no greater than those reported in the~     literature.~   "
126488|NCT01911845|"~     The purpose of this study is to evaluate the safety and efficacy of ABT-450/ritonavir/ABT-267~     (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and~     ABT-333 (also known as dasabuvir) coadministered with ribavirin (RBV) in hepatitis C virus~     (HCV) genotype 1-infected adults taking methadone or buprenorphine ± naloxone.~   "
126489|NCT01911832|"~     The incidence of cancer of the esophagogastric junction has rapidly risen in recent three~     decades, and surgery still remains the optimum therapy. For Siewert's type II and III cancer,~     esophagojejunostomy after total gastrectomy and Roux-en-Y gastrojejunostomy after subtotal~     gastrectomy are regarded as the two main surgical approaches. Esophagojejunostomy after total~     gastrectomy brings high survival rate and low local recurrence rate which may also induces~     pulmonary infection or regurgitation. Roux-en-Y gastrojejunostomy after subtotal gastrectomy~     needs reconstruction of the gastric tube and the width of reconstruction tube was a key~     factor to predicate prognosis. However, no evidence supplies a comprehensive standard on the~     width of reconstruction tube which often ranges from 3 cm to 6 cm. Both narrow and wide~     reconstruction tubes have their own advantages and disadvantages. So the prospective trail~     recruits patients into three groups: total gastrostomy group (TG group), wide gastric tube~     group (WG group) and narrow gastric tube group (NG group). And the investigators compare the~     quality of life using integrated questionnaire of QLQ-STO22 and QLQ-C30 and related symptom~     relief as main endpoints.~   "
126490|NCT01911819|"~     The purpose of this study is to compare new bone formation following bone graft in sinus~     using three different commercially available bone graft materials. The study hypothesis is~     that there is no difference in new bone formation among three bone graft materials under~     microscope.~   "
126491|NCT01911806|"~     This study aim to investigate the effects of back care pillow, in adjective with standard~     physical therapy treatment for chronic non-specific low back pain.~   "
126492|NCT01911793|"~     Postoperative ileus is common after colorectal surgery, occurring in up to 20% of patients.~     Stomas are frequently created in conjunction with major colorectal surgery. Obstruction at~     the level of the stoma is a common cause of bowel obstruction or ileus. This is often~     manifested by decrease or delay in stoma output and is often attributed to edema at the level~     of the stoma. Thus, a temporary tube (red robinson catheter) is placed into the stoma at~     bedside, which often relieves the obstruction until the edema at the level of the stoma~     resolves and stoma function occurs around the temporary tube. At this time, the tube is~     removed and the stoma continues to function normally.~      The purpose of this study is to evaluate whether a stoma tube (red-robinson catheter) placed~     at the time of stoma creation would reduce the incidence of postoperative ileus in patients~     undergoing major colorectal surgery with creation of a stoma.~   "
126493|NCT01911780|"~     This is a multi-centre, randomised, double-blind, active-controlled, parallel-group~     comparative trial to compare the fixed dose combination (FDC) of telmisartan 80 mg +~     hydrochlorothiazide 12.5 mg and amlodipine 5 mg (T80/A5/H12.5 mg) to telmisartan 80 mg+~     hydrochlorothiazide 12.5 mg (T80/H12.5 mg) in blood pressure lowering effect at week 8, the~     end of the double-blind period in essential hypertensive patients who fail to respond~     adequately to telmisartan 80 mg+ hydrochlorothiazide 12.5 mg.~      Patients are assigned to one of the two groups after a 6-week open-label run-in period taking~     T80/H12.5 mg.~      In addition the long-term safety of telmisartan 80 mg+ amlodipine 5 mg+ hydrochlorothiazide~     12.5 mg will be evaluated in a 52-week extension period.~      In the 52-week open label extension period patients who are assigned to the T80/A5/H12.5 mg~     group continue the T80/A5/H12.5 mg therapy, and patients who are assigned to the T80/ /H12.5~     mg group change to the T80/A5/H12.5 mg therapy.~   "
126494|NCT01911767|"~     The primary objective of the study is to prospectively evaluate pregnancy outcomes in women~     with multiple sclerosis who were exposed to a Registry-specified Biogen Multiple Sclerosis~     product during the eligibility window for that product. The Registry-specified Biogen MS~     products being studied are dimethyl fumarate, Pegylated human interferon beta-1a, and~     Dalclizumab High Yield Process (DAC HYP).~   "
126498|NCT01911715|"~     A study to investigate the excretion routes of radio-labelled MDV3100.~   "
126499|NCT01911702|"~     Acute abdomen is the clinical manifestation of irritation of the peritoneum, due to~     intra-abdominal generalized infection. With the exception of the primary ones which are the~     result of a bacterial translocation from the gastro-intestinal tract or an abdominal~     contamination for hematogenous way sometimes treatable with medical therapy alone,~     peritonitis represents a complex condition that requires an early surgical treatment.~      Mortality linked to the peritonitis is extremely high and variable between 42% and 80% when~     associated with a systemic framework of severe sepsis. This variability is linked to a number~     of risk factors, including advanced age of the patients, the presence of comorbidity, male~     sex, a poor nutritional status, and a number of re-operations; as well as specific~     characteristics related to the type of infection, the timing of surgery, the beginning of an~     appropriate and early antibiotic therapy.The post-operative treatment of the patient with~     peritonitis significantly affects the outcome of the same. The presence of peritonitis and~     then the seizure of large volumes of liquids and the possible state of systemic vasodilation~     induced by the infectious process, provide a framework of hypovolemia. There is a literature~     that identifies in abdominal trauma damage patient's volemic aggressive resuscitation an~     element of pejorative outcomes. The purpose of this work is to evaluate the clinical changes~     determined by a different volemic strategy.~   "
126500|NCT01911689|"~     To quantitatively analyze the T2* values of the head, body, and tail of normal pancreas, and~     observe the value of GRE T2*-weighted MRI in the diagnosis of acute pancreatitis and the~     relationship between the T2* value and the severity of AP.~   "
126501|NCT01911676|"~     This is a Phase II, randomized, double-blind, placebo-controlled, cross-over POC study of~     stable patients with Schizophrenia or Schizoaffective disorder. The primary objective of this~     study is to test the efficacy of treatment with one of two does of a glycine transporter~     inhibitor (GlyT1I) combined with cognitive remediation to enhavce cognitive function.~     Subjects will be randomized to one of two doses of the glycine transporter inhibitor (GlyT1I)~     and placebo twice daily in addition to their antipsychotic medication for 2 treatment~     periods, each lasting a minimum of 5 weeks. Treatment periods will be separated by a washout~     period lasting approximately 3 weeks.~   "
126502|NCT01911663|"~     This study is a randomized, double-blind, placebo-controlled clinical trial designed to~     evaluate the effect of Korean red ginseng supplementation on glucose control in subjects with~     impaired fasting glucose, impaired glucose tolerance or newly-diagnosed type 2 Diabetes~     Mellitus and to establish a clinical evidence on glucose control effect of KRG.~   "
126503|NCT01911650|"~     The overall goal of this proposal is to correlate ultrasound elastography technique with more~     standard clinically based outcome measures within the setting of a small sample sized group~     of patients affected by moderate-to- severe, chronic (>6months) midsubstance Achilles~     tendinopathy (AT).~   "
126504|NCT01911637|"~     VBY-036 may treat or prevent nerve pain. This study aims to find the highest safe and~     tolerable single dose of VBY-036 in healthy volunteers. Volunteers are randomly selected to~     receive one dose of either a placebo or VBY-036 (10, 30, 100, 300, 600 or 900 mg).~   "
126505|NCT01911624|"~     Safety and efficacy of direct thrombin inhibitors versus enoxaparin in patients with~     staphylococcus aureus bacteraemia.~      The study hypothesizes that inhibition of the coagulase-activity of S. aureus by direct~     thrombin inhibitors is safe and translates into a better outcome of patients with S. aureus~     bacteremia.~   "
126506|NCT01911611|"~     This randomized, double-blind, placebo-controlled study will evaluate the safety,~     tolerability, pharmacokinetics of RO6870868 in healthy volunteers. Subjects will be~     randomized to receive single ascending doses of either RO6870868 or placebo, with or without~     food.~   "
126507|NCT01911598|"~     This open-label, multicenter study will evaluate the safety, tolerability, and~     pharmacokinetics of MEHD7945A in combination with chemotherapy (either cisplatin plus 5-FU or~     carboplatin plus paclitaxel) in participants with previously untreated R/M SCCHN. There are~     two stages for each arm in this study: a Dose-limiting Toxicity (DLT)-evaluation stage (Stage~     I) and a cohort-expansion stage (Stage II). In Stage I, DLTs will be assessed during a DLT~     Assessment Window of 21 days (i.e., Cycle 1 Day 1 through Cycle 1 Day 21) for both arms. In~     Stage II, participants will be enrolled to further characterize the safety, pharmacokinetics,~     and anti-tumor activity of MEHD7945A in combination with cisplatin + 5-FU or carboplatin +~     paclitaxel at the identified recommended Phase II dose.~   "
126508|NCT01911585|"~     The purpose of this study is to determine whether 60-minute sessions of prolonged exposure~     (PE) are as effective as the standard 90-minute session for treating posttraumatic stress~     disorder (PTSD). Participants will include patients ages 18 or older with a current diagnosis~     of PTSD who are seeking treatment in our clinic. Patients who have current substance~     dependence, psychosis, and suicidal ideation with intent and plan may not be suitable for~     receiving PE and may be offered another treatment or referred to a different treatment~     center. Participants will be randomized to receive either the 90- minute or 60-minute PE~     session. A blind evaluator will assess for pre-treatment, post-treatment, and follow-up~     levels of symptom severity using the PTSD Symptoms Scale Interview (PSS-I). Participants will~     attend weekly treatment sessions with any of our faculty members and will complete~     self-report measures at every session (see below).~   "
126509|NCT01911572|"~     Invasive bacterial infection is a dangerous but relatively uncommon disease where bacteria~     spread deep into the body causing diseases like blood poisoning ('bacteraemia'), pneumonia,~     meningitis and others. The various bacteria of the streptococcus family are an important~     cause, often leading patients to require intensive care despite which, for some strains, one~     in five patients die. One notable form is called necrotising fasciitis, a condition where~     bacteria rapidly spreads through and destroys the layers of tissue just under the skin.~      As individuals vary greatly in their risk of developing such serious infections,~     investigating how the genome, the inherited blueprint of our bodies, of these patients~     differs from that of healthy volunteers can help to explain why the disease develops in some~     and not others. For some streptococcal bacteria such as Streptococcus pneumoniae this~     approach is already proving successful; for others such as the Group A strain~     (Streptococcus pyogenes) it has yet to be explored but carries excellent potential.~      The investigators have secured the support of the Lee Spark Necrotising Fasciitis Foundation~     to recruit from their membership survivors of streptococcal infections and some of their~     family members. The investigators will also ask infection specialists from NHS hospitals to~     invite patients they have looked after. The investigators also have a small existing~     collection. Taking part would involve registering information on a website, discussing the~     study on the telephone and then providing us with a sample of saliva from which the~     investigators can isolate DNA. The investigators would prepare the sample for analysis of the~     genome and compare the patients with both their family and an existing reference collection~     from healthy volunteers using technology that reads the DNA code.~      Our study will be a first key step in renewing efforts to understand the determinants of~     invasive streptococcal infection, which is important for developing better treatments and~     vaccines.~   "
126510|NCT01911559|"~     Children with Cerebral Palsy and quadriplegia or severe diplegia suffer from highly reduced~     mobility and consequent constipation. Clinicians frequently recommend standing-frames to~     exercise the support reaction in this population, sharing the opinion that the upright~     position may facilitate intestinal transit, although no evidence supports this assumption.~      The investigators conducted this single-subject research to determine the effects of the~     standing-frame on the frequency of evacuation in chronically constipated children with CP and~     quadriplegia.~      Moreover, the investigators studied its effects on the frequency of induction of evacuation,~     the characteristics of the stool and the pain suffered by the child due to constipation~     and/or evacuation.~   "
126511|NCT01911546|"~     A growing number of patients on the kidney transplant waiting list are broadly human~     leukocyte antigen (HLA) sensitized (HS). These patients are unlikely to have a compatible~     donor. Therefore they wait longer and have increased morbidity and mortality. Desensitization~     with intravenous immune globulin (IVIG) and rituximab with alemtuzumab induction improves~     transplant rates and achieves good allograft outcomes. However, HS patients are at risk for~     viral infections after transplant. We have previously shown an increased incidence of BKV~     infections after desensitization with HS patients having higher peak viral loads.~     Cytomegalovirus (CMV) and polyomavirus BK (BKV) infections place HS renal transplant~     recipients at particular risk. Allograft rejection is associated with both CMV and BKV~     infection. This is of particular concern for HS patients as they are at an increased risk of~     rejection at baseline. Furthermore, the frequent development of leukopenia after~     transplantation often requires the CMV prophylactic agent to be discontinued along with~     lowering immunosuppression. This increases the risk of CMV infection and allograft rejection.~      Everolimus was approved for rejection prophylaxis in combination with calcineurin inhibitors~     (CNI). CNI used in the study that led to drug's approval was cyclosporine. There are several~     trials nearing it's completion that utilize low dose tacrolimus instead. In 2012 Novartis~     published data from several trials showing superior outcomes using everolimus + low dose~     tacrolimus. This combination is currently approved in EU. It is also a combination that is~     standard of care (SOC) at our center for patients on everolimus.~      This study aims to demonstrate that use of everolimus as part of a maintenance~     immunosuppression regimen may decrease viral infections without lowering overall~     immunosuppression thus improving allograft function and survival.~   "
126512|NCT01911533|"~     Hypothesis:~      Extracorporeal removal of CO2 can treat hypercapnia and respiratory acidosis, which allows~     application of lung protective ventilation. This downgrading of mechanical ventilation~     promotes better and more quickly lung recovery.~      Aim:~      The aim of the study is to treat respiratory acidosis and to reduce plateau pressures by~     using an extracorporeal removal of CO2 (ECCO2-R).~      This prospective study will include 10 patients with an Acute Respiratory Distress Syndrome~     (ARDS). ARDS is an inflammatory response in the lungs, the onset is acute with pulmonary~     oedema and shows bilateral densities on chest radiography. The take up of oxygen and the loss~     of CO2 in the lungs are difficult. Moreover the patient's blood can become acidic due to too~     much CO2.~      To promote a better gas-exchange, the patient with ARDS will be mechanically ventilated. This~     can be aggressive and harmful for the lungs. With the use of an extra-corporeal CO2-remover,~     CO2 can be removed so that the mechanical ventilation setting will be less aggressive and~     will decrease lesions in the lung. The veno-venous extracorporeal CO2-remover pumps blood~     from a vein via a catheter through an oxygenator (gas exchanger that adds oxygen to the blood~     and extracts carbon dioxide from the blood) and back into a vein.~      The investigators will use a standard dialysis catheter that will be put in a large vein. To~     prevent clotting of the system, the patient will receive heparin.~      In the study the investigators will work in periods of two hours, the situation before and~     after carbon dioxide removal will be compared. With this study the investigators want to~     prove that the CO2 in the blood decreases with at least 20 % with the use of the~     extracorporeal CO2 remover. More over the investigators want to prove that lower mechanical~     ventilation settings (thanks to CO2-removal by the ECCO2-R) will produce fewer lesions to the~     lungs.~   "
126513|NCT01911520|"~     During laparoscopic bariatric surgery, adequate muscle relaxation is important to maintain~     good surgical conditions. To achieve this muscle relaxation, neuromuscular transmission~     blocking agents, such as rocuronium (Esmeron®) are used. It sometimes happens that there is~     still some neuromuscular blocking activity left in the patient on awakening from anesthesia.~     This is called residual curarization and is known to cause postoperative complications such~     as impairment of respiratory function.~      Sugammadex (Bridion®) is a novel drug which selectively binds rocuronium (Esmeron®). It~     allows for reversing of neuromuscular transmission blocking activity. Until now, all studies~     with sugammadex were performed in non-obese patients.~      Obese patient have a high risk to suffer from post-operative respiratory failure. Therefore~     it is vital to avoid residual curarization. Sugammadex might be an important factor.~      Obese patients have a large total body weight different from ideal body weight. Recent~     research demonstrated that the dose for the neuromuscular blocking agent rocuronium~     (Esmeron®) needs to be calculated on the patients' Ideal Body Weight rather than on Total~     Body Weight.~      At this moment no data is available on the dose-response relationship of sugammadex in~     morbidly obese patients.~      We hypothesize that in morbidly obese patients sugammadex should be dosed on ideal~     bodyweight, instead of total bodyweight.~   "
126514|NCT01911507|"~     This phase I trial studies the side effects and best dose of c-Met inhibitor INCB028060 and~     erlotinib hydrochloride when given together in treating patients with previously treated~     non-small cell lung cancer. C-Met inhibitor INCB028060 and erlotinib hydrochloride may stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
126515|NCT01911494|"~     This project is being undertaken to test the hypothesis that implementing a community based~     package of care for women with hypertensive disorders of pregnancy will result in overall~     improvement in maternal and neonatal outcomes. This is based on the premise that there are~     three main modifiable reasons why women (and their fetuses/newborns) die due to pregnancy~     complications: 1) delays by the woman herself in recognizing the seriousness of her~     condition; 2) delays in her being assessed and then transported to a center capable of~     providing effective and life-saving interventions; and 3) delays in the health facility in~     providing those interventions. The treatments for pre-eclampsia that are poorly accessed in~     LMIC are 1) magnesium sulfate (MgSO4) for prevention and treatment of the grand mal seizures~     of eclampsia; 2) oral antihypertensive medication to lower maternal BP to reduce the risk of~     stroke.~      The CLIP pilot and definitive cRCT will investigate whether the community level intervention~     including implementation of the CLIP package (oral antihypertensive therapy when indicated,~     intramuscular (i.m.) MgSO4 when indicated; and appropriate referral to an CEmOC facility when~     indicated) of care will reduce the incidence of all-cause maternal morbidity and mortality.~   "
126516|NCT01911481|"~     The investigators are carrying out a study of 164 pregnant women, with breech presentation at~     term who will undergo to external cephalic version. The investigators' goal is to know if~     oral maternal hydration can increase the successful of external cephalic version~   "
126517|NCT01911468|"~     The purpose of this study was to determine whether combined treatment with liraglutide and~     metformin is more effective than liraglutide or metformin as monotherapy in the treatment of~     obese women with polycystic ovary syndrome (PCOS) who had been previously poor responders~     regarding weight reduction on metformin monotherapy. We anticipated greater changes in body~     weight in patients on combined treatment than in those on monotherapy with liraglutide or~     metformin.~   "
126521|NCT01911416|"~     Pancreatic cancer is considered a rare form of cancer with about 277,000 new cases diagnosed~     in 2008 world-wide, which is about 2.5% of all forms of cancer. However, pancreatic cancer is~     more common in developed countries where the rate of this tumor is on the rise compared to~     other types of cancer.~      LDE225 is a new medicine that blocks a cellular pathway (called Hedgehog pathway) that is~     thought to be changed in some patients with pancreatic cancer. LDE225 is a medicine which has~     not been approved by the FDA for the treatment of people with your medical condition. The~     medicine being tested in this study is currently not on the market (available to buy) in~     any country.~      The purpose of this study is to see the effect LDE225 has on blood and tumors.~   "
126522|NCT01911403|"~     Clinical study in patients undergoing any intervention requiring vascular access to the~     femoral artery. The study compares Angio-Seal™ vs. Manual Compression with regard to control~     the vascular access.~      It is designed to demonstrate superiority of the Angio-Seal™ with an unchanged risk-profile.~   "
126523|NCT01911390|"~     A multidisciplinary team of clinicians and researchers will conduct a pilot feasibility study~     to evaluate whether dietary intake of dry bean powder or rice bran or a combination is a~     helpful dietary recommendation to reduce total cholesterol levels in children with~     identified, modifiable CVD risk factors, elevated total cholesterol and obesity. Consumption~     of dry bean powder and rice bran merit additional investigation to study feasibility and~     acceptability in children and how they influence their lipid levels or obesity.~   "
126524|NCT01911377|"~     This study will examine the efficacy of Botulinum Toxin Type A (Botox) in treating~     Allodynic-type neuropathic pain in people with spinal cord injury or multiple sclerosis.~      Neuropathic pain is pain initiated or caused by injury to or disease of the nervous system,~     and is common in spinal cord injury patients or people with multiple sclerosis.~      Allodynia is a type of neuropathic pain caused by something that normally would not cause~     pain, such as light touch, pressure from clothing, or bed sheets brushing against the skin.~      Botox has been used to treat the muscle overactivity that causes spasticity in spinal cord~     injured patients. It has been noticed to exert some analgesic(pain relieving) effect, and has~     recently been studied as a treatment for neuropathic pain.~      We want to see if Botox, injected intradermally, will relieve the symptoms of allodynic-type~     neuropathic pain.~      24 volunteers are to be enrolled, with 16 receiving active treatment, and 8 controls~     receiving placebo.~   "
126525|NCT01911364|"~     The purpose of this study is to determine the triple combination of beclometasone~     dipropionate+Formoterol fumarate+Glycopyrrolate bromide is effective for the treatment of~     severe COPD patients (chronic obstructive pulmonary disease)~   "
126526|NCT01911351|"~     Title:~      High-concentration continuous flow nitrous oxide use for procedural-induced pain or anxiety~     during pediatric minor procedures.~      Objective: To assess whether the use of high-concentration continuous flow nitrous oxide in~     addition to standard management increases the comfort level in pediatric patients undergoing~     minor procedures compared to standard management alone.~   "
126527|NCT01911338|"~     -  Background Context: no studies have been identified to analyse the effect of real time~          feedback (using inertial sensors) on physiotherapy students learning the art of~          posterior-anterior thoracic manipulation (PATM).~        -  Purpose: to study the effect caused by real-time feedback on the learning process for~          PATM, comparing two undergraduate physiotherapy student groups. Hypothesis: significant~          differences will exist in the execution parameters of manipulation among students~          receiving real-time feedback versus those who do not.~        -  Study Design/Setting: longitudinal, pre-post intervention.~        -  Patient Sample: Sixty-one undergraduate physiotherapy students were divided randomly~          into two groups, G1 (n = 31) (group without feedback in real time) and G2 (n = 30)~          (group with real-time feedback).~        -  Outcome Measures: time, displacement and velocity and improvement (only between groups)~          to reach maximum peak, to reach minimum peak from maximum peak, total manipulation time.~        -  Methods: two groups of physiotherapy students learned PATM, one using a traditional~          method and the other using real-time feedback (inertial sensor). Measures were obtained~          pre- and post-intervention. Intragroup pre- and post-intervention and intergroup~          post-intervention scores were calculated. An analysis of the measures' stability was~          developed through an ICC (1,2).~        -  Results: the values of ICC ranged from 0.881 to 0.997. Statistically significant~          differences were found in all variables analysed (intra- and inter-group) in favour of~          G2.~        -  Conclusions: the learning process for posterior-anterior thoracic manipulation is~          facilitated when the student receives real-time feedback.~   "
126528|NCT01911325|"~     This is a multi-center, open-label Phase Ib dose escalation part followed by a randomized~     double-blinded placebo controlled Phase II part.~      The Phase Ib part will determine the Maximum Tolerated Dose (MTD)/Recommended Phase II Dose~     (RP2D) of buparlisib in combination with docetaxel. Subsequently the MTD/RP2D will be~     investigated in a Phase II randomized trial in patients with advanced or metastatic squamous~     NSCLC.~   "
126529|NCT01911312|"~     An investigation into the relative effectiveness of thermal-aided muscle stimulation vs. body~     temperature muscle stimulation for eliciting muscle contraction in the quadriceps~   "
126530|NCT01911299|"~     The purpose of this study is to determine whether choline supplementation can improve~     cognitive functioning of children with prenatal alcohol exposure.~   "
126531|NCT01911286|"~     Clinical diagnostic of brain death requires a non-reactive coma, absence of brain stem~     reflex, and absence of spontaneous breathing. The confirmation of absence of spontaneous~     breathing is established the apnea test (according to the American Academy of Neurology's~     Guidelines). However this test may lead to complications (acute hypoxemia, ventilatory and~     cardiocirculatory disorders) and reduces significantly the number of lung transplants. Some~     data suggest modifying the apnea test : replace the ventilator switching off with continuous~     positive airway pressure (CPAP) use. These studies showed that this alternative method (CPAP)~     increased the level of lung harvest but they were not sufficient because these studies were~     monocentric with little patients,. That why the aim of the present study is to compare the~     standard strategy and CPAP strategy with a prospective, multicenter,cluster trial; each~     center will use the method of apnea test which it uses usually.~   "
128337|NCT01887561|"~     The purpose of this study is to assess whether dasatinib can be discontinued without~     occurrence of molecular relapse in patients with chronic myeloid leukemia in chronic phase in~     complete molecular remission(CMR) while on dasatinib.~   "
126532|NCT01911273|"~     The primary purpose of the study is to explore whether treatment with PF-03446962 and best~     supportive care is better than placebo plus best supportive care in prolonging survival of~     patients affected by recurrent liver cancer. In addition, the study will explore if adding~     PF-03446962 to best supportive care is safe, how PF-03446962 is metabolized, if there are~     patients' characteristics (biomarkers) that may predict response to PF-03446962, and if~     PF-03446962 has any effect on the patients' quality of life.~   "
126533|NCT01911260|"~     The purpose of this study is to measure the effect of weekly zinc supplementation on~     schoolchildren with growth deficit or normal stature.~   "
126534|NCT01911247|"~     The overall goal of this proposal is to investigate the potential benefit of metformin as a~     novel therapy for the treatment of endometrial cancer. Investigators will evaluate the effect~     of short-term metformin treatment on the endometrium of obese women with endometrial cancer~     by comparing each patient's endometrial biopsy before treatment with metformin to their~     post-treatment hysterectomy specimen.~      Participants: Obese women who are to undergo surgical staging for endometrial cancer will~     also receive short-term treatment (1-4 weeks) with metformin that will continue until the day~     prior to surgical staging.~      The effect of metformin on proliferation, apoptosis and downstream signaling pathways will be~     compared between pre-treatment endometrial biopsies and post-treatment hysterectomy~     specimens. Tissue microarrays will be constructed and immunohistochemstry performed to~     evaluate proliferation, apoptosis and changes in critical signaling pathways mediated by~     metformin, and these findings will be correlated with our in vitro preclinical studies. Fresh~     tissue will also be obtained, and Western immunoblotting will be used to assess expression of~     the phosphorylated forms of the downstream targets of metformin. The hypothesis is that~     treatment with metformin will result in a decrease in proliferative markers and an increase~     in markers of apoptosis in the endometrial cancer tumors. AMPK phosphorylation and inhibition~     of critical downstream targets of the mTOR pathway will be seen in the post-treatment~     hysterectomy specimens. Metabolomic profiling will also be performed of tumors and associated~     biofluids (i.e. serum and urine) before and after treatment with metformin to identify~     potential biomarkers of response to this therapy.~   "
126535|NCT01911234|"~     The safety and immunogenicity of the TNF-Kinoid (TNF-K) have been evaluated in a phase II~     clinical study conducted in subjects with Rheumatoid arthritis. Preliminary results of~     clinical efficacy are promising.~      The principal aim of the present study is to confirm the clinical efficacy of the TNF-K in~     subjects with Rheumatoid arthritis in whom treatment with methotrexate is not working~     anymore. Subjects who have never been treated with anti-TNFα monoclonal antibodies will be~     enrolled in this trial. In addition, the immune responses and the safety elicited by TNF-K~     will also be evaluated.~   "
126536|NCT01911221|"~     The study will evaluate the immunogenicity and safety of the rMenB+OMV NZ in an adult~     population potentially at risk for meningococcal disease (e.g. lab workers).~   "
126537|NCT01911208|"~     The purpose of this study is to test a recruitment intervention to increase racial and ethnic~     diversity in clinical trials. The trial will be conducted in specialty care clinics. In~     RECRUIT minorities are those underrepresented in clinical trials and include:~        -  African Americans/ Blacks~        -  Asians~        -  Native Hawaiians/Other Pacific Islanders~        -  Hispanic/Latinos~        -  Native Americans/Alaskan Natives~   "
126538|NCT01911195|"~     Currently it is unknown how the human brain reorganizes its network organization to generate~     conscious experience and cognitive activity after a period of unconsciousness. Therefore, the~     purpose of this study is to assess how cognitive activity is reconstructed after general~     anesthesia. The investigators hypothesize that the brain's transition from unconsciousness to~     consciousness and full cognition is a complex process that occurs over an extended period of~     time. Specifically, the investigators hypothesize the following order of cognitive~     reconstitution: responsiveness to command, attention, complex scanning and visual tracking,~     working memory, and executive function.~      Volunteers will be healthy participants who are anesthetized with commonly used anesthetic~     drugs as well as a non-anesthetized group to control for circadian influences. A total of 60~     subjects will be recruited for this study. All subjects (male and female) will perform basic~     tests for cognition on a laptop computer at 30-minute intervals during this study. The~     testing battery to be administered was assembled to assess multiple cognitive functions in~     order to determine whether and how cognitive processes return to baseline function.~     Electroencephalogram (measuring brain electrical activity) data will be monitored and~     recorded during both anesthesia and cognitive testing, for subsequent analysis.~      This study is significant because it could lead to a better understanding of the neural~     correlates of human consciousness, as well as normal and abnormal conscious state transitions~     (including barriers to such transitions).~   "
126539|NCT01911182|"~     In premature infants, apnea of prematurity is one of their major clinical problems. Caffeine~     is currently a worldwide therapy to reduce the number and severity of these apneas. This~     practice has shown to be safe on cognitive and neurodevelopmental outcomes at 18 to 21 months~     of age. However, caffeine is not 100% effective, and may have little effect on hypoxemia and~     bradycardia. Infants with intractable apneas unresponsive to caffeine treatment may require~     endotracheal intubation and mechanical ventilation. This procedure is invasive and has been~     associated with complications and increased risk for chronic lung disease and adverse~     neurodevelopmental outcome. Therefore, an alternative treatment modality would be preferable~     if it would prevent the infants from requiring endotracheal intubation. The investigators~     have been testing the overall hypothesis that small concentrations of inhaled CO2 (~1%) are~     effective in treating apnea of prematurity. The investigators have completed three studies in~     preterm infants showing that inhalation of low concentration of CO2, in infants not on~     caffeine, regularize breathing and decrease apneas significantly. The effects of inhalation~     of CO2 in infants already on caffeine, are unknown. The hypothesis to be tested is that~     inhalation of low concentration CO2 (1%) will significantly reduce apnea in infants treated~     with caffeine. The investigators have three specific aims in this proposal. 1) the~     investigators want to know if the apnea rate (number of apneas of ≥5 seconds/hour) is~     decreased with CO2 inhalation in preterm infants already on caffeine for the treatment of~     apnea of prematurity; 2) the investigators want to know whether inhalation of CO2 can make~     breathing more regular with less apneic time and whether it decreases prolonged apneas (>20~     seconds) in infants already on caffeine for the treatment of apnea of prematurity; 3) the~     investigators want to assess the effect of inhalation of low concentration of CO2 on the~     regional oxygen saturation of the brain measured by near-infrared spectroscopy (NIRS) during~     apneas. This is to see whether CO2, by protecting cerebral blood flow, minimizes the decrease~     in cerebral oxygenation during apneas. This study entails a new and possibly more~     physiological method of treating apneas of prematurity that can be added to the present~     treatment of caffeine. These two treatments together, could minimize the number and severity~     of apneas and possibly decrease the need for mechanical ventilation in preterm infants.~   "
126566|NCT01910831|"~     To determine the efficacy (measured at 12 weeks) of DerMend Moisturizing Bruise Formula in~     improving the appearance of bruising and reducing the appearance of photoaging of the~     forearms and hands in mature skin. Assessments will be made through ongoing objective~     measurements and clinical ratings.~      To confirm the safety (local tolerance) of DerMend Moisturizing Bruise Formula.~   "
126540|NCT01911169|"~     Determine the effect of vitamin D repletion on flow mediated dilation (FMD, a measure of~     endothelial function) in vitamin D deficient systemic lupus erythematosus (SLE) patients. The~     investigators will enroll vitamin D deficient SLE patients and randomize them to receive~     either 400 IU or 5,000 IU of cholecalciferol (D3) daily and measure change in FMD as a~     measure of EC function at baseline and after 16 weeks of repletion.~      Determine mechanisms by which vitamin D repletion may improve endothelial function in vitamin~     D deficient SLE patients and in vitro.~      Determine effect of oral D3 repletion on the Type I interferon signature in WISH and ECs~     cultured with pre and post plasma from D3 treated lupus patients.~      Determine effect of D3 repletion on the number of circulating apoptotic and non-apoptotic EC~     and EPC ex vivo.~      Determine effect of exogenous 1,25(OH)D on IFN gene signature in WISH and ECs stimulated by~     pretreatment SLE plasma in vitro.~      Determine the effects of exogenous 1,25(OH)D on the phenotype of ECs cultured with~     pretreatment lupus plasma.~      This study is designed to efficiently test our hypothesis and begin to define~     interferon-dependent pathways through which vitamin D repletion can restore clinical and in~     vitro endothelial function.~   "
126541|NCT01911156|"~     This is a prospective randomized, open-label, phase IV clinical trial to learn the effects,~     good and/or bad, of discontinuing or continuing nucleos(t)ide analogue (NA) treatment for 72~     weeks in participants with chronic hepatitis B infection whose immune system is controlling~     the amount of virus levels in the blood for at least 12 months of NA therapy.~      About 66 adult men and women will participate in this study from University Health Network~     which includes the Toronto Western Hospital for about 72 weeks.~   "
126542|NCT01911143|"~     This is a retrospective, blinded, external validation study of a novel in-vitro diagnostic~     (IVD) assay that will include samples that were previously collected from febrile pediatric~     patients. The investigated assay measures the levels of a few host-related, blood-based,~     bio-markers that will be integrated into a single score. Based on this score, each patient~     will be classified into one of three categories: (i) bacterial immune response, (ii) viral~     immune response, and (iii) marginal immune response. The assay prediction and the patient~     diagnosis will than be unveiled and compared to determine their level of concordance.~   "
126543|NCT01911130|"~     A new strength measurement device called Accurate Test of Limb Isometric Strength (ATLIS) was~     developed to precisely and conveniently measure static limb strength in patients with ALS.~     The investigators will compare ATLIS data with data from two commonly used ALS outcomes~     measures, the ALS Functional Rating Scale-Revised (ALSFRS-R) and slow vital capacity (SVC) in~     a prospective, longitudinal study. All three outcomes measures will be performed on 100~     subjects collected preferably at bi-monthly clinic visits during the study period.~   "
126544|NCT01911117|"~     In one previous study, esCCO was compared with continuous thermodilution CO (TDCO),~     measurements in 36 postoperative cardiac surgery patients, showing a bias (mean difference)~     of -0.06 and a precision (1 SD) of 0.82 L/min. In addition, esCCO was compared with~     intermittent bolus TDCO, showing a correlation coefficient of 0.82 (P < 0.001, n = 24), a~     bias of -0.63, and a precision of 1.01 L/min (n = 119). The results of clinical use of esCCO~     suggest that its measurement accuracy is comparable to the thermodilution method in general~     population. However, no any intraoperative comparison for cardiac surgery patients was~     reported before. This study is designed for the accuracy in the patients undergoing cardiac~     surgery.~      Specific aims:~        1. To investigate the correlation of esCCO and the traditional CO measurement in cardiac~          surgical patients.~        2. To investigate the intraoperative t accuracy of time point between ecCCO and traditional~          CO measurement for patients undergoing bypass cardiac surgery.~   "
126545|NCT01911104|"~     The purpose of this study is to collect data to help researchers identify factors that~     prevent certain individuals from receiving the beneficial effects of exercise.~   "
126546|NCT01911091|"~     The purpose of this study is to collect data to help researchers identify factors, such as~     certain proteins or genetic codes, that are secreted from muscle that are associated with the~     beneficial effects of exercise.~   "
126547|NCT01911078|"~     The purpose of this clinical investigation is to determine the effects of renal sympathetic~     denervation on insulin resistance and muscle sympathetic nerve activity in patients with~     metabolic syndrome.~   "
126548|NCT01911065|"~     In this study the investigators are trying to identify immune signatures that are associated~     with effective or poor vaccine responses to naturally-acquired herpes zoster virus and the~     zoster (shingles) vaccine, Zostavax.~   "
126549|NCT01911052|"~     Inadequate bowel preparation results in decreased rates of cecal intubation, increased rates~     of missing important lesions, increased patient discomfort, higher risk of complications,~     prolonged procedure time and increased health-care cost. Recent study reported that~     Telephone-based re-education (TRE) on the day before colonoscopy significantly improved the~     quality of bowel preparation and polyp detection rate. However, there is no study to compare~     the effect of telephone with short message system (SMS) based re-education on the quality of~     bowel preparation in health screened population. Our goal is to improve the quality of bowel~     preparation with telephone or SMS based re-education for outpatients undergoing screening~     colonoscopies. The investigators hypothesise that efforts to improve education and maximise~     patient compliance during the preparatory period will enhance the efficacy of bowel~     preparation.~   "
126550|NCT01911039|"~     Chronic graft versus host disease (cGVHD) is a common complication of bone marrow or~     hematopoietic cell transplant from another person (allogeneic transplant). This study will~     determine if subjects with steroid dependent/refractory cGVHD can tolerate infusion of donor~     regulatory T cells and whether their cGVHD responds to the infusion.~   "
126587|NCT01910558|"~     Saturated fat leading to elevated low density lipoprotein (LDL) cholesterol is considered a~     cardiovascular risk factor. The properties associated with α- cyclodextrin, allow it to~     selectively reduce saturated fat and calories which will have a medically beneficial effect~     on LDL cholesterol and obesity. The purpose of the research is to evaluate this effect of α-~     cyclodextrin. It is hypothesized that alpha cyclodextrin supplementation will increase fecal~     fat on a high saturated fat diet compared to the same diet supplemented with a digestible~     carbohydrate control~   "
129126|NCT01877239|"~     This is a prospective non-interventional observational study to evaluate the treatment of~     moderately active RA patients in every day clinical practice in Austria. Patients will be~     observed over 52 weeks. The primary endpoint will be percentage of patients who reach CDAI~     remission after 24 weeks.~   "
126551|NCT01911026|"~     Effective bowel preparation is important for examination of the entire colon adequately and~     for identifying colonic lesions during colonoscopy. However, it is well known that bowel~     preparation of inpatients is much poorer than that of outpatients. Our goal is to improve~     bowel preparations with reinforcement of nurse education that explains the steps required for~     bowel preparation for inpatients undergoing colonoscopies. The education will focus on~     explaining the purpose of a screening colonoscopy, the rationale for bowel preparation, the~     pre-colonoscopy diet, and the instructions for completing the laxative. Patients in the~     control group will receive the standard written bowel preparation instructions, while~     patients in the intervention group will receive standard written instructions plus a~     explanation from reinforcement-educated nurse. The investigators hypothesize that patients~     received a explanation from reinforcement-educated nurses will lead to improved patient~     compliance and a better bowel preparation. In addition, the investigators hypothesize that a~     better quality bowel preparation will improve detection of colonic polyps and patients'~     satisfaction for colonoscopy.~   "
126552|NCT01911013|"~     The purpose of this study is firstly to determine the efficacy of cervical plate for anterior~     cervical discectomy and fusion using cervical cage, and secondly to investigate the~     determining factors for surgical outcomes.~   "
126553|NCT01911000|"~     The presence of portal vein tumor thrombosis (PVTT)in patients with HCC is one of the most~     significant prognostic factors for poor prognosis, without treatment, their survival is less~     than 3 months. In the HCC patients who combined with PVTT, RT showed 50% of local control and~     about 10 months survival duration. Despite the standard treatment of the HCC combined with~     PVTT is sorafenib, but Korean Liver Cancer Study Group (KLCSG) recommend RT as an option in~     those patients. Investigators previously reported the retrospective study that the scheduled~     interval TACE followed by RT for HCC combined with PVTT and 60% of the patients showed~     objective response without significant elevation of complication. It is reported that~     hyperthermia considered as the most valuable radiosensitizer in cancer treatment,~     theoretically. Based on those studies, we start this prospective study to evaluate the~     objective response and adverse event in the combination treatment of RT and hyperthermia~     after Transarterial chemoembolization (TACE) in the unresectable HCC patients who combined~     with PVTT.~   "
126554|NCT01910987|"~     The objective of this study is to describe the effect of optimized retreatment with~     bortezomib in combination with dexamethasone followed by prolonged therapy with bortezomib,~     versus standard retreatment with bortezomib in combination with dexamethasone on progression~     free survival (PFS).~   "
126555|NCT01910974|"~     safety evaluation of endoscopic sub-mucosal dissection with nestis enki2 system. This system~     is a new water jet system which allows to perform Endoscopic submucosal dissection with a~     bifunctional catheter (injection and cutting).~   "
126556|NCT01910961|"~     To investigate the influence of limb remote ischemic preconditioning (LRIP) on mortality,~     hospitalization costs and quality of life in patients undergoing open infrarenal abdominal~     aortic aneurysm (AAA) repair.~   "
126557|NCT01910948|"~     To evaluate immunomodulatory effects of perioperative application of omega-3 polyunsaturated~     fatty acids in gastric cancer surgery, the effects of postoperative recovery, the improvement~     of nutritional status, incidence rate of related complications, and whether it can reduce the~     average postoperative hospitalization days.~   "
126558|NCT01910935|"~     The purpose of this study is to evaluate the effectiveness of a program to increase the~     physical activity of hypertensive patients using medical services and sports facilities of~     the Mexican Social Security Institute. The primary hypothesis to be proven is: The~     intervention will increase the proportion of hypertensive patients complying the physical~     activity minimum at week to get benefits on health in 20%, compare to patients in control~     group.~   "
126559|NCT01910922|"~     The aim of this study is to understand the formation of food preferences from an early age.~   "
126560|NCT01910909|"~     1. Background 1.1. Hepatocellular carcinoma (HCC) HCC is the third most common cause of~     cancer death globally. It is also the second cause of cancer mortality in Korea, despite the~     incidence of HCC was fifth. The most important cause of this discrepancy is connected with~     the fact that the significant portion of the HCC is detected as unresectable status.~      1.2. Standard treatment of the HCC At the point of HCC diagnosis, only 30% of the patients~     could receive standard curative treatment, like resection, liver transplantation, and~     radiofrequency ablation (RFA). Transcatheter arterial chemoembolization (TACE) has been shown~     in randomized trials to improve survival compared with symptomatic therapy alone, in the~     patients without macrovascular involvement, extrahepatic disease and tumor related symptoms.~     However, in the recent review of TACE, TACE might be contraindicate or not recommended in the~     patients who showed vascular tumor invasion, more than 10 cm size, poor portal blood flow~     and/or repeated poor response.~      Recently, Sorafenib, which is one of the target agents, showed survival advantage on~     unresectable HCC patients in two randomized study. In those study, sorafenib improved~     approximately three month overall survival increment, however, the median survival duration~     was only 10.7 months in experiment group (received sorafenib), and even 6.5 months in~     Asian-Pacific trial. Additionally, the possibility that sorafenib effect could be reduced in~     the patients had hepatitis B virus (HBV) was suggested in the subgroup analysis.~      1.3 Radiation therapy (RT) for the HCC The use of RT in HCC is increased with the radiation~     technological advances. In the unresectable patients, RT showed 50 to 60% response rate with~     the dose response relationship. Recently, stereotactic body radiation therapy (SBRT) showed~     excellent local control and comparable survival rate in thoracic tumor. In the HCC, SBRT also~     showed 75 to 100% local control rate without significant elevation of the toxicities. One~     study reported that 24 to 54 Gy SBRT achieved 87% 1year local control and 17 months overall~     survival. The standard treatment of unresectable HCC is sorafenib, but Korean Liver Cancer~     Study Group (KLCSG) recommend RT as an option in localized unresectable HCC. Furthermore,~     Radiation Therapy Oncology Group (RTOG) started randomized trial to confirm the effect of~     SBRT in unresectable HCC (RTOG 1112).~      Investigators previously reported the retrospective result that the higher dose SBRT achieved~     2 year overall survival 87.9% and local control 85% in the patient who showed less than 5 cm~     solitary HCC without portal vein involvement.~      Based on those studies, we start this prospective study to evaluate the effectiveness and~     adverse event of SBRT in the patients who had solitary 3 cm or less size HCC without~     extrahepatic lesion and vascular involvement.~   "
126561|NCT01910896|"~     To investigate the effectiveness of an Overnight Intensive Patch (OIP) on improvement of post~     dermatological surgery scars and its safety over 12 to 24 weeks.~   "
126562|NCT01910883|"~     This is the first time finafloxacin was administered to humans intravenously. The principal~     aim of this study was to obtain safety and tolerability data when finafloxacin was~     administered intravenously as single and multiple doses to healthy subjects.~   "
126563|NCT01910870|"~     To evaluate response rate of cisplatin - metronomic cyclophosphamide treatment.~   "
126564|NCT01910857|"~     -  The overall hypothesis for the project is that racial health disparities will be reduced~          by improving hypertension control in African Americans.~        -  This will be accomplished through the development, implementation, and evaluation of a~          cost-effective hypertension control strategy based on the involvement of a community~          health worker.~   "
126567|NCT01910818|"~     Radiotherapy, an essential modality in cancer treatment, frequently induces a fibrotic~     process in the skin which can lead to increased risk of malignancy, poor wound healing, pain~     and limitation of movement, and permanent loss of skin appendages with~     hyper/hypopigmentation, decreased sweating and xerosis, posing significant cosmetic and~     quality of life issues. Advances in laser therapy has led to the use of fractional laser~     treatment (FLT) to treat fibrosis associated with in hypertrophic scars and morphea, leading~     to tissue repair, scar remodeling. The investigators propose a pilot clinical study to test~     the hypothesis that FLT can normalize the fibrotic process and induce normal scar remodeling~     in patients affected by chronic radiation injury. Understanding and correcting this~     underlying fibrotic process can help restore normal skin functions in patients affected with~     chronic radiation dermatitis (RD) and other debilitating fibrotic diseases in dermatology~     such as scleroderma, morphea, or nephrogenic systemic fibrosis.~   "
126568|NCT01910805|"~     Women with a history of gestational diabetes (GDM) have a substantially increased risk of~     developing type 2 diabetes. In fact, 50-70% of these women will go on to develop type 2~     diabetes within the 20 years following their GDM-complicated pregnancy. Perceived risk of~     developing type 2 diabetes among women with a history of GDM may be particularly important to~     altering behavior changes associated with reducing risk. Certain populations have lower~     perceived risk of developing type 2 diabetes, despite having a higher prevalence of the~     disease. Specifically, African-Americans have a lower perceived risk of developing type 2~     diabetes compared to whites, despite their more than doubled risk of developing the disease.~     Improvement in awareness of diabetes risk among African-American women at high-risk of~     developing type 2 diabetes, such as those with a history of GDM, could reduce future risk of~     this disease among this group.~      As such, we will conduct a two-armed, pilot randomized controlled trial to evaluate whether a~     postpartum diabetes education intervention, incorporating nutrition, exercise, and diabetes~     risk assessment can improve diabetes risk awareness, diet, and physical activity levels at~     1-year post-pregnancy among African-American women with a recent history of gestational~     diabetes.~      We hypothesize that attendance at a 3-month and 9-month postpartum diabetes education class~     will:~        1. Improve diabetes awareness as measured using the Risk Perception for Developing Diabetes~          among women in the intervention group compared to women in the control group when~          measuring at 3-months postpartum compared to 12-months postpartum~        2. Improve dietary habits and physical activity levels in the intervention group compared~          to the control group when measuring at 3-months postpartum compared to 12-months~          postpartum~   "
126569|NCT01910792|"~     Patients with fat malabsorption due to Crohn's disease, ulcerative colitis, or other causes~     including cystic fibrosis, among others, or who have undergone gastric bypass have increased~     incidence of vitamin D deficiency relative to the general population. Given that vitamin D is~     fat soluble and absorbed in the proximal small intestine, it has been documented that vitamin~     D deficiency in people with a fat malabsorption syndrome is due to decreased absorption of~     vitamin D.~      The amount of vitamin D produced from winter sunlight (in Boston, MA) and dietary sources~     will negligibly raise blood vitamin D levels in these patients, and oral vitamin D~     supplementation may have limited efficacy due to malabsorption. A variety of UV light sources~     have been developed and sold as in-home tanning devices and to produce vitamin D in reptiles.~     The efficacy of correcting vitamin D deficiency by the skin exposure to an artificial source~     of UVB radiation in patients with fat malabsorption syndromes (Crohn's disease, ulcerative~     colitis, or cystic fibrosis) or after gastric bypass surgery has not been studied. The~     investigators have conducted a pilot study in healthy adults that demonstrated that exposure~     to the lamp raised the blood level of 25-hydroxyvitamin D with no side effects. The main~     purpose of this study is to evaluate the effect of the FDA approved artificial source of~     ultraviolet (UVB) radiation (Sperti® lamp) in improving vitamin D status in patients with fat~     malabsorption syndromes and patients who have undergone roux-en-Y gastric bypass surgery.~   "
126570|NCT01910779|"~     Use of higher energy doses (120-150 J) may not offer additional benefits and higher success~     rate compared with low to moderate initial energy (100-120 J) of biphasic shock for atrial~     fibrillation cardioversion. In this prospective open-label randomized trial consecutive~     patients with AF and candidate to AF electrical cardioversion will be randomized to receive~     100J or 120 J as initial dose of biphasic shock. Patients will be also randomized in each~     group to anterolateral or postero-anteriore placement of defibrillator electrodes.~   "
126571|NCT01910766|"~     Objective of the study was to evaluate the effect of combination of oral Coenzyme Q10~     (CoQ10), with clomiphene citrate (CC) for ovulation induction in CC-resistant polycystic~     ovary syndrome (PCOS).In a prospective controlled randomized trial performed in a university~     hospital and private practice setting. One hundred ten infertile women with PCOS resistant to~     CC were randomized to either combined CC/CoQ10 (51 patients, 82 cycles) or CC 150 mg/day~     alone (50 patients, 71 cycles) for ovulation induction in patients with CC-resistant PCOS.~      Main outcome measures: Number of follicles, serum E2, serum P, endometrial thickness,~     pregnancy rate (PR) and miscarriage rate.~   "
126572|NCT01910753|"~     The purpose of this study is to examine the feasibility of resistance training and physical~     functioning associated with nutrition therapeutic education in head and neck cancer patients,~     during their treatment (chemotherapy with or without radiotherapy).~   "
126573|NCT01910740|"~     The main aim of this study is to investigate whether increasing the amount of physical~     activity in frail older people during hospital based rehabilitation is associated with better~     mobility outcomes compared to usual care. A second aim is to investigate whether this~     physical activity intervention is associated with improvements in health related quality of~     life. Finally we plan to investigate whether increasing the amount of physical activity~     during rehabilitation is cost effective, measured from a health system perspective, compared~     with usual care.~      Older people receiving inpatient rehabilitation will be randomly assigned to an intervention~     group, who will receive extra physical activity on weekdays and weekends or a control group,~     who will receive additional activities based on social interaction. The activity sessions~     will be individualized to the particular participant. Both groups of people will be assessed~     at baseline, discharge from hospital and at 6 months following discharge. The intervention~     group will be provided with one or two extra sessions on weekdays and two extra sessions on~     weekends for the duration of their rehabilitation stay. To account for the extra~     physiotherapy time that the intervention group receives, the people in the control group will~     spend the same amount of time performing other activities, such as cards, board games or~     reading, whilst seated. To ensure the safety of the participants in this study, each physical~     activity session will be supervised by either a physiotherapist or allied health assistant.~      Hypothesis 1: The primary hypothesis is that, compared with usual care, increasing the amount~     of physical activity in frail older people during rehabilitation will lead to more optimal~     mobility at discharge, as measured by gait speed.~      Secondary hypotheses are that, compared with usual care, increasing the amount of physical~     activity during rehabilitation will:~      Hypothesis 2: lead to significantly greater improvements in mobility and function both at~     discharge and six months following discharge.~      Hypothesis 3: lead to better quality of life six months following hospital discharge,~     measured using the EuroQol Health (EQ5D) Questionnaire and the EuroQol-Visual Analogue Scale~     (EQ-VAS).~      Hypothesis 4: be cost effective compared to usual care~   "
126574|NCT01910727|"~     The objective of the Together on Diabetes study is to test the efficacy of a pilot~     intervention to improve the prevention and management of type 2 diabetes among American~     Indian youth.~      The primary aim of this study is to determine the impact of the Together on Diabetes pilot~     intervention on youth diabetes risk behaviors, including:~        -  Improvement in youth dietary intake, with a specific focus on reducing the percent of~          total calories from fat.~        -  Improvement in youth physical activity, with a specific focus on increasing the number~          of minutes of physical activity each week.~      An additional primary aim of the study is to determine the feasibility and acceptability of~     the pilot intervention and evaluation, including program adherence and program satisfaction.~      The secondary aim of this study is to determine the feasibility of collecting data to~     determine program impact on a number of physiological measures.~   "
126575|NCT01910714|"~     The investigators seek to adapt, implement and evaluate a randomized controlled trial of an~     evidence based intervention delivered by Apache interventionists to reduce HIV/AIDS risk,~     targeting Apache adolescents. Specific study objectives include:~        1. To perform formative research through focus groups and individual interviews on~          attitudes, practices and intervention preferences among Apache adolescents and community~          stakeholders.~        2. To adapt the Focus on Youth (FOY) evidence-based intervention using findings from the~          formative research, components of Protection Motivation Theory, and input from a~          community advisory board.~        3. To enroll 304 White Mountain Apache youth ages 13-19 to participate in a randomized~          intervention trial measuring behavior change at 6- and 12- months follow-up.~        4. To determine the feasibility of gathering biological specimens via self-administered~          swabs to track sexually transmitted diseases among 18-19 year olds enrolled in this and~          future studies.~   "
126576|NCT01910701|"~     The aim of the proposed research is to implement and evaluate a follow-up study of the impact~     of the Family Spirit family strengthening program among a high-risk sample of Apache mothers~     and their children. The Family Spirit intervention is a 52-session home-visiting curriculum~     administered by American Indian paraprofessionals to young mothers from 28 weeks gestation~     through the child's first 3 years of life. In a series of pilot studies and a recently~     completed randomized controlled trial, the Family Spirit intervention has been found to~     positively impact several maternal, parenting and child outcomes up through three years~     postpartum. In the proposed study, the investigators will implement the Family Spirit~     intervention to young mothers (12-20 years at conception), with revisions to several~     assessment measures and to the curriculum such that the substance abuse prevention curriculum~     modules will be taught earlier than in the original study.~   "
126577|NCT01910688|"~     The present study will assess the feasibility of using endoscopic radiofrequency ablation~     (RFA) to treat the gastric pouch and stoma with the intent to cause tissue contraction and~     decreased compliance after a failed Roux-en-Y gastric bypass.~   "
126578|NCT01910675|"~     The purpose of the study is to find out if the regimen of prothrombin complex concentrate~     (PCC) together with fibrinogen concentrate is as efficient as fresh frozen plasma (FFP) (plus~     fibrinogen if needed) during the early stages of the transfusion therapy in postpartum~     haemorrhage (PPH). The original protocol included the use of HES and the recruitment of~     patients was postponed while waiting the final decision by EMA. All HES solutions were~     abandoned at our institution in September and an amendment was made to change the protocol.~     HES solution are replaced by the use of hyperoncotic (20%) albumin.~   "
126579|NCT01910662|"~     This is an exploratory study to develop methodologies for the assessment of T-cell mediated~     therapies via skin immune challenges studies in healthy volunteers. The study will~     investigate what is the most appropriate; skin challenge agent, time and methodology to~     sample and characterise T-cells in the delayed type hypersensitivity (DTH) skin reaction. The~     skin challenge agents to be used in this study will be the neoantigen Keyhole Limpet~     Hemocyanin (KLH) and recall antigen Tuberculin Purified Protein Derivative (PPD). Part A of~     the study will assess an intradermal (ID) KLH challenge in three subjects to assess if the~     immune response to KLH is initiated by the innate or adaptive immune system. Each subject~     will receive one ID dose of 0.1 milligram (mg) KLH and will be assessed for a skin~     inflammatory response. Part B of the study will assess repeat ID challenges 28 days apart;~     the objective will be to characterise the T-cell response to each challenge and the kinetics~     of that response.~      For Cohorts 1A and 1B, 16 subjects will receive an initial subcutaneous (SC) 5 mg dose of~     KLH. Fifteen days later the subjects will receive 0.1 mg ID KLH dose and the response will~     then be assessed 48 and 120 hours after the initial challenge. The ID KLH challenge will then~     be repeated 28 days later and the response will be assessed at 48 hours (Cohort 1A, 8~     subjects) and at 120 hours (Cohort 1B, 8 subjects) post challenge. For Cohort 2, a repeat~     challenge of either 2 tuberculin Unit (TU) or 10 TU ID PPD will be administered 28 days~     apart, to 8 subjects. The first challenge response will be assessed 48 and 120 hours post~     challenge. The second challenge will be administered 28 days after the first and will be~     assessed at the same timepoints. The repeat challenge 28 days later will allow an~     intra-subject analysis and will determine if a subject can be used as their own control. Part~     C of the study will assess repeat ID challenges of PPD and PBS; the objective will be to~     characterise the T-cell response to each challenge and the kinetics of that response. For~     Cohort 1, 6 subjects will receive a 0.1ml ID dose of PBS and another dose 24 hours later.~     Each challenge will be assessed 48 hours post challenge. Approximately 2 subjects will have~     an assessment of their normal skin as a control. For Cohort 2, a repeat challenge of either~     2TU or 10TU ID PPD will be administered 28 days apart, to 6 subjects. The first challenge~     response will be assessed 48 post challenge. The second challenge will be administered 28~     days after the 1st and will be assessed at the same timepoint. The repeat challenge 28 days~     later will allow an intra-subject analysis and will determine if a subject can be used as~     their own control.~      The total duration of this study for Part A is 14-18 days plus up to 30 days screening. The~     total duration of this study for Cohort 1A is 56-60 days plus up to 30 days screening. The~     total duration of this study for Cohort 1B is 59-63 days plus up to 30 days screening. The~     total duration of this study for Cohort 2 if 2TU is used is 45-49 days plus up to 30 day~     screening. The total duration of this study for Cohort 2 if 10TU is used is 48-51 days plus~     up to 30 days screening. The total duration of this study for Part C Cohort 1 is 15-19 days~     plus up to 30 day screening. The total duration of this study for Cohort 2 if 2TU is used is~     42-46 days plus up to 30 day screening. The total duration of this study for Cohort 2 if 10TU~     is used is 45-49 days plus up to 30 days screening.~   "
126580|NCT01910649|"~     The purpose of the extension phase of this study is to determine whether Drisapersen is~     effective in the treatment of boys with Duchenne muscular dystrophy resulting from a mutation~     thought to be corrected by exon 51 skipping.~   "
126581|NCT01910636|"~     This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF)~     plus ribavirin (RBV) in Japanese participants with chronic genotype 2 hepatitis C virus (HCV)~     infection.~   "
126582|NCT01910623|"~     This study will focus on acute promyelocytic leukemia patients who have been diagnosed more~     than 5 years ago and their present quality of life.~      The possible late effects of cancer treatment can include several issues and, thus, there has~     been an increasing interest worldwide in studying the long-term impact of these in patients'~     life.~   "
126583|NCT01910610|"~     STRATEGIC-1 is a study designed to determine the best sequence of therapy in patients with~     metastatic colorectal cancer.~   "
126584|NCT01910597|"~     Soluble Beta-Glucan (SBG) is a compound prepared from commercial active dry Baker's yeast~     which is then proceeded through a multi-step laboratory processes invented by Prof. Rapepun~     Wititsuwannakul, Faculty of Science, Prince of Songkla University, Thailand. Based upon~     pre-clinical data, SBG has been shown to inhibit angiogenesis and probably enhance immune~     function, leading to shrinkage of tumor size in athymic nude mice injected by hepatocellular~     carcinoma cells (HepG2) and cervical cancer cells. Therefore, the investigators expect to see~     the safety and anti-cancer property of SBG in patients with advanced cancer whom no available~     therapy can be offered.~   "
126585|NCT01910584|"~     The aim of this study is to investigate the influence on the quality of life and sexual~     function before, 6 month and one year after Novasure Endometrial Ablation in the treatment of~     Menorrhagia.~   "
126586|NCT01910571|"~     -  This is a single centre, phase I, randomized, double-blind, placebo-controlled,~          crossover, dose escalating study of P7435 using single and multiple doses, to be~          conducted in healthy male and female (Non child bearing) subjects having BMI between 19~          to 40 kg/m2.~        -  The study will be conducted in 2 parts as follows: Part A will consist of the Single~          Ascending Dose (SAD) study and Part B will consist of the Multiple Ascending Dose (MAD)~          study.~   "
126628|NCT01910012|"~     Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from~     microbes that degrade arginine. ADI has been formulated with polyethylene glycol and has been~     used to treat patients that have cancers that require arginine. In this study, the~     investigators will evaluate the response rate, as determined by the revised International~     Working Group recommendations.~   "
126588|NCT01910545|"~     The purpose of this study is to test the safety and tolerability of an investigational drug~     called OTS167. OTS167 is a maternal embryonic leucine zipper kinase (MELK) inhibitor which~     demonstrated antitumor properties in laboratory tests. It is being developed as an~     anti-cancer drug. In this first-in-human study OTS167 will be administered to patients with~     solid tumors which have not responded to treatment.~   "
126589|NCT01910532|"~     This is a single-arm, open label safety and dose titration study evaluating the use of~     Clevidipine to rapidly control elevated blood pressure in patients who have an Intracranial~     Pressure Monitoring device.~   "
126590|NCT01910519|"~     This study will compare the different immune responses to Influenza A (H5N1) Virus Monovalent~     Vaccine with and without the AS03 adjuvant. The Influenza A (H5N1) Virus Monovalent Vaccine~     with AS03 adjuvant vaccine is approved for use for adults to protect against flu caused by~     the A/H5N1 bird flu virus in Europe but none of the vaccines to be used in the study are~     approved for use in the United States. The results of this study will help researchers learn~     about better ways to vaccinate people against the H5N1 flu.~   "
126591|NCT01910506|"~     This study will determine the characteristics of absorption, metabolism, and excretion (AME)~     of RDEA3170 following a single 10 mg dose of RDEA3170 oral solution with 500 microcuries~     (µCi) of [14 C]RDEA3170 in healthy adult male subjects.~   "
126592|NCT01910493|"~     Mobile phone SMS are increasingly used to promote positive health behaviour with an aim to~     improve health outcomes. However, robust data on the efficacy of SMS on health seeking~     behaviour and patient outcomes in resource-limited settings is sparse. The SMSaude study aims~     to assess whether regular SMS-reminders improve retention on antiretroviral therapy (ART) and~     prevention of mother to child transmission of HIV (PMTCT) programmes in Mozambique.~   "
126593|NCT01910480|"~     The purposes of this study are to: learn about the safety of the study drug (NBI-98854);~     learn how subjects tolerate the study drug; and evaluate and compare the pharmacokinetics (PK~     testing, the study of how the body absorbs, distributes, breaks down and eliminates a drug)~     of the investigational study drug after taking it alone and with ketoconazole. Ketoconazole~     is known to affect the PK of many drugs and is studied to more safely prescribe medications.~   "
126594|NCT01910467|"~     Objectives Firstly to examine in preterm neonates, whether it is possible to reduce number of~     hypotensive episodes and use of catecholamines by applying cerebral/peripheral near infrared~     spectroscopy in combination with predefined interventions and secondly to explore the~     potential impact on cerebral injury and mortality.~      Hypothesis By using predefined interventions for changes in cerebral/peripheral oxygenation~     ratio investigators will reduce hypotensive episodes and use of catecholamines which will~     reduce cerebral injury and mortality.~      Methods Cerebral (cTOI) and peripheral-muscle (pTOI) tissue-oxygenation-index (NIRO 300) will~     be measured for 24h starting <6 hours postpartum. When cTOI/pTOI ratio increases >5% within a~     6h period, predefined interventions will be performed.~      Primary outcome parameter will be duration of hypotensive episodes and use of catecholamines~     during the first 48h after birth. Secondary outcome parameters will be cerebral injury and~     mortality.~   "
126595|NCT01910454|"~     Stroke is the most serious disabling condition in the United States and the developed world.~     Novel stroke rehabilitation approaches, such as task-specific training, have shown promise in~     improving an individual's recovery in the rehabilitation setting; however, evidence suggests~     that these improvements are not generalized or transferred to the home, community, or work~     settings. Thus, these interventions usually do not impact overall health and participation~     outcomes. This research study seeks to improve task-specific training as a stroke~     rehabilitation approach by integrating it with evidence-based cognitive-oriented strategies~     which have shown great promise as a way to address the limitations of task-specific training.~     The new treatment protocol is called Cognitive-Oriented Strategy Training Augmented~     Rehabilitation, or COSTAR. The hypothesis of this study is that COSTAR will result in more~     efficient functional skill acquisition, better long-term retention of skills learned, and~     generalization and transfer of skills learned to home, community, and work settings.~   "
126596|NCT01910441|"~     Compare the effect of Vildagliptin plus Metformin versus Glimepiride plus Metformin on~     glucose variability in T2DM patients.~   "
126597|NCT01910428|"~     Asparaginase (Asp) is used during the induction phase of ALL treatment for children and young~     adults. Its efficacy is counterbalanced by its toxicity, mainly in patients 40 years or~     older. The efficacy rate in older adult population is lower than for children or young~     adults. A recent review on outcomes in older adults with ALL pointed out that there were~     significantly more drug reductions, omissions or delays in the older group as compared to~     younger adults and that asparaginase was the drug most commonly omitted.~      The investigational product ERYASPASE is a dispersion for infusion of homologous red blood~     cells (RBC) encapsulating E. coli L-asparaginase.~      A previous European phase I/II clinical study in children and adults (<55 yo) at first~     relapse of ALL was conducted to determine the optimal dose of homologous RBC encapsulating~     native E. coli Asp (GRASPA®) in 24 patients with relapsed ALL. The activity and safety~     profiles of 3 doses of GRASPA® (50, 100 and 150 IU/kg) in combination with standard~     chemotherapy were compared to free native Asp. The global safety profile is also improved,~     reducing hypersensitivity, liver toxicity and coagulation disorders. Study showed that a~     single dose of GRASPA® 150 IU/kg induced a depletion in plasmatic asparagine for 18.6 days,~     i.e. similar to that obtained with 8 injections of 10,000 IU/m² of free native Asp. A~     reduction in the incidence and severity of the allergic reactions and coagulation disorders~     were observed with GRASPA® (Domenech 2011).~      A French phase II study designed to determine the maximum tolerated dose of GRASPA® in~     combination with a polychemotherapy regimen in ALL patients older than 55 yo at first~     diagnosis has been performed, and showed that both 100 and 150 IU/kg doses fulfilled the~     predefined criteria for efficacy and tolerability but the better profile of 100 IU/kg dose~     was considered the optimal dose in this setting. A phase II/III trial in adult and children~     patients with relapsed ALL is currently ongoing.~      Based on these results, the combination of ERYASPASE with the CALGB chemotherapy regimen~     appears to be an attractive combination for the treatment of adults patients with ALL/LBL.~   "
126598|NCT01910415|"~     This study is designed to evaluate the effect of multiple doses of lumacaftor in combination~     with ivacaftor on cardiac repolarization, as detected by QT/QTc interval corrected for heart~     rate in healthy subjects.~   "
126599|NCT01910402|"~     This study is designed to demonstrate the non-inferior antiviral activity of DTG/ABC/3TC~     fixed dose combination (FDC) once daily (OD) compared to atazanavir plus ritonavir (ATV+RTV)~     and tenofovir disoproxil fumarate/emtricitabine fixed dose combination (TDF/FTC FDC) OD in~     HIV-1 infected, ART-naïve women over 48 weeks. This study will also characterize the safety~     and tolerability of DTG/ABC/3TC FDC compared to ATV+RTV+TDF/FTC FDC. Sufficient number of~     subjects will be screened in order to ensure a total of approximately 474 subjects will be~     randomized (237 in each study arm)~   "
129127|NCT01877226|"~     The purpose of this study is to evaluate pharmacokinetics (explores what the body does to the~     drug), safety and tolerability of single and multiple-dose of tapentadol in healthy~     participants.~   "
126600|NCT01910389|"~     This study is a multi-center, prospective, randomized, double blind, placebo-controlled~     clinical trial. Subjects in the study will be adults with New York Heart Association (NYHA)~     Class II-IV heart failure (HF) due to left ventricular systolic dysfunction (LVSD), left~     ventricular ejection fraction (LVEF) <0.40, and secondary pulmonary hypertension (PH). The~     purpose of the study is to evaluate the safety, effectiveness, and effects of tadalafil~     compared to placebo on the subjects' functional capacity / quality of life.~   "
126601|NCT01910376|"~     Cancer is a disease of the elderly. Cancer incidence is 11-fold higher in persons over the~     age of 65, than in younger ones. Approximately 60% of all cancers and 70% of cancer mortality~     occurs in people older than 65 years. Moreover, due to the aging of the population in the~     Western world the number of elderly people is expected to increase and therefore the number~     of older cancer patients is expected to rise. Despite this rapid increase in cancer incidence~     and cancer-related mortality with age, our knowledge about ageing and cancer and about~     optimal treatment for older cancer patients is still far from adequate. Therefore, it is~     clear that cancer in the elderly is a major and increasing health problem. A key problem in~     geriatric oncology research is the important selection bias because very old/frail patients,~     are very rarely included in clinical trials.~      Changes in the patterns of health care delivery have shifted the care of the elderly from~     acute care settings to the community and long-term care facilities. As the European~     population ages, more and more people will become nursing home residents, many of whom will~     have a suspicion of, or be diagnosed with, and eventually die from, cancer. Although cancer~     is very common in elderly nursing home residents, it is poorly studied. This lack of~     information may impact on clinical decision making and the appropriateness of treatments~     offered and therefore collection of this information is needed.~      This project has two main objectives. The first objective is to report on demographics,~     referral patterns and motives for non-referral, anti-cancer treatments and outcome of~     patients in nursing homes with suspected or diagnosed active invasive cancer where a~     diagnostic or treatment decision has to be taken. The second objective is to develop better~     prognostic tools (for survival) including biological markers of ageing to help treatment~     decisions in the elderly.~   "
126602|NCT01910363|"~     To test the safety and efficacy of a new generation botulinum toxin preparation A2NTX for~     treating stroke patients with lower limb spasticity.~        -  we study the degree of spasticity in the ankle and knee joints, and walking speed in 30~          patients with stroke before and after injecting 300 units of BOTOX or A2NTX in a blinded~          manner as for the patient, the physician, and the examiner.~        -  we also assess the safety of A2NTX and compare it to that of BOTOX.~   "
126603|NCT01910350|"~     1) To determine if the Kin KeeperSM Cancer Prevention Intervention increases first time and~     appropriately timed breast cancer screening rates among Black, Latina and Arab women; 2) To~     determine if the Kin KeeperSM Cancer Prevention Intervention increase first time and~     appropriately time cervical cancer screening rates among Black, Latina and Arab women; 3) To~     measure functional cancer literacy over time at the individual and familial level and 4)~     Assess rates of healthcare utilization cost among women in the Kin KeeperSM intervention and~     control-comparison groups.~   "
126604|NCT01910337|"~     The purpose of this study is to use heart rate variability as a monitor of cardiovascular~     safety during third molar surgeries, using the Polar heart rate-meter.~   "
126605|NCT01910324|"~     The fundamental objective of the proposed study is to develop and test an innovative~     two-stage, cross-systems family-based intervention for substance abusing juvenile offenders.~     The first stage of the experimental treatment is provided for youths in juvenile detention~     settings. Stage two of the intervention occurs after the offender is released to the~     community. Participants are randomized to one of two study conditions: the cross-systems~     family-based intervention (Multidimensional Family Therapy-Cross Systems (MDFT-CS), or 2)~     Enhanced Services as Usual (ESAU). Both conditions incorporate HIV prevention in detention~     and we will also examine the effects of a family-based HIV/STD prevention module beyond the~     impact of a standard HIV/STD education intervention delivered in detention by including~     ongoing HIV/STD intervention in MDFT-CS following release from detention. There are five aims~     of the proposed study. These aims relate to: 1) Intervention development and implementation;~     2) Clinical effectiveness; 3) Impact of HIV/AIDS/STD prevention; 4) Comparative~     benefit-costs; and 5) Systems-level impact~   "
126606|NCT01910311|"~     The purposes of this study are to look at what effect multiple doses of rifampicin have on a~     single dose of baricitinib and to look at the safety and tolerability of these drugs. Side~     effects will be documented. The study will last approximately 31 days from the first dose to~     the end of the study.~   "
126607|NCT01910298|"~     This is a prospective, multicenter, non-randomized, parallel design comparing a primary~     efficacy endpoint between subjects undergoing immediate post-mastectomy breast reconstruction~     with a breast implant and Strattice™ Reconstructive Tissue Matrix (TM) and subjects~     undergoing immediate, two-stage post-mastectomy breast reconstruction, where the initially~     placed expander will be exchanged for a breast implant only, without any type of~     reinforcement.~   "
126608|NCT01910285|"~     The main objective is the comparison of intubation conditions after anesthetic induction~     bolus of propofol-sufentanil when compared to injection of propofol-remifentanil in patients~     undergoing surgery for tooth extraction.~      Intubation without myorelaxant with propofol and sufentanil is classic but less efficient~     than induction with curare on achieving perfect intubation conditions. The use of a protocol~     without curare is sometimes justified for short gestures or when you want to avoid allergia.~     Remifentanil often provides excellent intubation conditions without myorelaxant. However,~     remifentanil was never compared to sufentanil in terms of intubating conditions without~     muscle relaxant.~   "
126609|NCT01910272|"~     Invasive cardiac procedures involve procedural guidance with x-rays in the form of~     fluoroscopy. X-ray exposure poses a potential risk of acute and long-term complications to~     staff involved in these procedures. Lead shields are placed between the operators (on their~     left side) and the x-ray source to limit exposure. However as the operator requires direct~     access to the patient and x-ray scatter occurs, full protection is not possible. Lead gowns,~     thyroid collars, and leaded glasses are typically worn to protect the body, thyroid, and eyes~     respectively, but their thickness is limited by their relatively heavy weight. Nevertheless~     this leaves the brain exposed. Further, interest in the risk of brain cancer in invasive~     cardiologists has re-emerged after a recent report of left-sided brain cancer in primary~     operators of interventional cardiology procedures. Lead caps have been tested in the past but~     the relatively heavyweight of lead has limited wide-spread implementation. The cap typically~     worn during invasive procedures is lightweight, has no significant x-ray absorption~     properties, and is worn to help maintain a sterile environment. A novel, lead-free cap,~     composed mainly of barium sulfate and bismuth oxide, has been developed that has been shown~     to absorb x-rays while being significantly lighter than lead. The investigators propose using~     multiple x-ray detectors to test exposure differences between the primary and secondary~     operators, the left side and right side of the head, and absorption via a lead-free cap.~   "
126610|NCT01910259|"~     Multiple sclerosis (MS) is a disabling and progressive neurological disease that affects~     approximately 100,000 people in the UK. Many patients with MS experience two phases of~     disease; early MS (also called relapsing remitting MS, RRMS) and late MS (also called~     secondary progressive MS (SPMS). Early MS is due to inflammation of the nerves and the~     insulation (called myelin) that surrounds the nerves. Early MS is often characterised by~     periods of attacks interspersed with periods of remission with no or low disease~     symptoms. Late or progressive MS, which affects the majority of patients and typically~     emerges after 10-15 years of disease, results from actual nerve death (also called~     neurodegeneration). The progressive stage of disease results not in individual attacks but~     slow, cumulative and irreversible disability affecting walking, balance, vision, cognition,~     pain control, bladder and bowel function. Critically, and unlike early disease, there is no~     proven treatment for the late stage of MS. This is therefore an urgent and major unmet health~     need. MS-SMART directly addresses this need and will evaluate in this clinical trial three~     drugs (fluoxetine, riluzole or amiloride), all of which have shown some promise in MS, and in~     particular in SPMS. The trial is randomised and blinded. Randomisation means patients can get~     any one of the three active drugs or the inactive placebo/dummy; blinded means that neither~     patients nor the doctors will know which drug or placebo patients are receiving.~     Randomisation and blinding are standard approaches in clinical trials to ensure unbiased~     testing of drugs. All patients in MS-SMART will have periodic MRI (magnetic resonance~     imaging) brain scans and after 96 weeks these will be analysed. We will then compare the~     scans of each drug to the placebo or dummy to see if any of the drugs slow the rate of brain~     shrinkage that normally occurs in SPMS. This measured change in brain size is the primary~     (major) outcome of MS-SMART.~   "
126611|NCT01910246|"~     It has been shown that asymptomatic obese adolescents can demonstrate abnormal regional~     myocardial contraction, with preserved global cardiac function. Metformin has been shown to~     decrease cardiovascular mortality in patients with type 2 diabetes and insulin resistance,~     but the mechanism of cardiovascular protection is unknown.~      The purpose of this study is to evaluate the reversibility of subclinical cardiovascular~     abnormalities in obese adolescents with insulin resistance after a six-month course of~     Metformin. The investigators hypothesized that the beneficial effects of Metformin will be~     progressive and sustained after six months of therapy.~   "
126612|NCT01910233|"~     This is a prospective registry of patients presenting with acute dyspnea to the emergency~     department of the city hospital in Nuremberg. There is evidence that acute dyspnea is~     associated with a mortality rate of 10%, however acute dyspnea is not perceived as a~     life-threatening condition, both in public and in health care providers. Our aim is to~     describe the patient collective concerning their demographics, baseline characteristics, type~     of referral and disposition, medical care processes and prognosis. Secondly, we want to~     evaluate if the subjective risk assessment of emergency department personnel matches with~     objective risk stratification tools and the actual outcome of the studied patients.~   "
126613|NCT01910220|"~     This is a study to assess the safety and bioeffect of REGN1033 (SAR391786) in healthy~     volunteers.~   "
126614|NCT01910194|"~     Impact of combined Lantus (insulin glargine) and Lyxumia(lixisenatide) on insulin secretion~     and gastric emptying~   "
126615|NCT01910181|"~     This open-label, multicenter study will evaluate the pharmacokinetics, safety and efficacy of~     vemurafenib in Chinese participants with BRAF V600 mutation-positive unresectable or~     metastatic melanoma. Participants will receive vemurafenib 960 milligrams (mg) orally twice~     daily until disease progression or unacceptable toxicity occurs.~   "
126616|NCT01910168|"~     In this single center study blood samples for biomarker analysis will be collected from~     patients with spinal muscular atrophy. Up to 21 mL blood will be drawn from eligible patients~     at a single visit.~   "
126617|NCT01910155|"~     The objective of this study is to compare the relative efficacy and safety of the test~     formulation of ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension (Par~     Pharmaceutical Companies, Inc.) to the already-marketed formulation CIPRODEX® (ciprofloxacin~     0.3%/dexamethasone 0.1%) sterile otic suspension (Alcon) in the treatment of acute bacterial~     otitis externa.~   "
126618|NCT01910142|"~     The present study aims to develop a technique based on a single dose of a calcium isotope,~     which enables to determine the effect of a nutritional intervention on bone calcium~     metabolism. For this purpose nutritional interventions with calcium, vitamin D and vitamin K~     will be applied in postmenopausal women. Treatment effects will be determined by the urinary~     excretion of the calcium isotope and related to classical bone markers.~   "
126619|NCT01910129|"~     The purpose of this study is to see the effects of non-invasive vagal nerve stimulation for~     the reduction in frequency of seizure associated with epilepsy in subjects 18 or older.~   "
126620|NCT01910116|"~     GCSB-5 (Shinbaro capsule), is a mixture of 6 oriental herbs that have anti-inflammatory and~     analgesic effects along with an excellent safety profile. This study is aimed at~     investigating efficacy of Shinbaro in the treatment of hand osteoarthritis which needs a long~     term treatment in a placebo controlled, double-blind randomized trial.~   "
126621|NCT01910103|"~     Diagnostic performance of digital breast tomosynthesis (DBT) would be not inferior to the~     that of breast ultrasound in women with dense breast.~   "
126622|NCT01910090|"~     To assess the bioequivalence of Test oral formulation of FLURBIPROFEN 100 mg FAMOTIDINE 20 mg~     MULTI-LAYER TABLET versus Reference ANTADYS®100 mg Comprimé Pelliculé & PEPCID® (Famotidine)~     20mg Tablets, USP.~   "
126623|NCT01910077|"~     The purpose of this study is to demonstrate bioequivalence between tacrobell capsule 1mg and~     prograf capsule 1mg.~   "
126624|NCT01910064|"~     This open label study is to determine the safety profile of GK530G in a long-term treatment~     (up to 12 months) in subjects with acne vulgaris and to evaluate the efficacy of GK530G in a~     long-term treatment.~   "
126625|NCT01910051|"~     The rationale for this trial is to apply a simple and minimally strenuous pre-screening~     approach prior to performing more extensive trial-specific screening and~     baseline-characterization activities in the resulting pre-selected population of subjects.~   "
126626|NCT01910038|"~     It has been reported that around 40% of GCA patients are able to decrease the prednisone dose~     until 0.1 mg/Kg/d or less after 6 months of treatment. In this study, we hypothesized that~     adding 3 months of tocilizumab to prednisone could increase the percentage from 40 to 70%.~   "
126627|NCT01910025|"~     Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from~     microbes that degrade arginine. ADI has been formulated with polyethylene glycol and has been~     used to treat patients that have cancers that have arginine. In this study, the primary~     efficacy variable will be assessment of tumor response rate.~   "
132590|NCT01831817|"~     The purpose of this exploratory study is to compare the treatment effect on dentinal~     hypersensitivity of a tubule occluding dentifrice as measured by Schiff and Tactile~     sensitivity. This proof of concept study will compare the test dentifrice with three other~     treatment groups.~   "
126629|NCT01909999|"~     The aim of this study was to compare the release of the osteoprotegerin (OPG), transforming~     growth factors (TGF-α), osteocalcin (OCN), osteopontin (OPN), and parathyroid hormone (PTH)~     during osseointegration of dental implants with and without immediate loading. Forty patients~     were selected and randomly divided into: Group IM - implant and prosthesis placement within~     72 hours; and Group NL - implant insertion and no prosthesis placement during 120 days.~     Peri-implant crevicular fluid (PICF) was collected immediately after implant insertion and~     with 7, 15, 30, 60, 90, and 120 days after surgery and were evaluated levels of OPG, TGF-α,~     OCN, OPN and PTH using Luminex assay. Clinical aspects (Sulcus bleeding and peri-implant~     probing depth) were also assessed. The data were compared using the ANOVA/Tukey and~     Friedman/Mann-Whitney tests (α=5%).~   "
126630|NCT01909986|"~     This is a single dose mass balance study in healthy adult male volunteers to investigate the~     metabolism and excretion of [14C]-ONO-4053.~   "
126631|NCT01909973|"~     The goal of this project is to develop and pilot a mobile smartphone delivered intervention~     that will improve antidepressant medication care by providing medication adherence monitoring~     and support to the patient, feedback on patient adherence and response to treatment to the~     primary care team, and information to both patients and providers on guideline-congruent care~     personalized to the patient's response to antidepressant medication.~   "
126632|NCT01909960|"~     Normal pressure hydrocephalus diagnosis based on quantitative study of cerebro-spinal fluid~     and blood flow by phase contrast magnetic resonance imaging.~   "
126633|NCT01909947|"~     The investigators hypothesize that machine learning methods using a combination of novel,~     quantitative measures of cardio-respiratory variability can accurately predict the optimal~     time to extubate extreme preterm infants. In this multicenter prospective study,~     cardiorespiratory signals will be recorded from 250 extreme preterm infants who are eligible~     for extubation. Automated signal analysis algorithms will compute a variety of metrics for~     each infant describing the cardiorespiratory state. Machine learning methods will then be~     used to find the optimal combination of these statistical measures and clinical features that~     provide the best overall predictor of extubation readiness. Finally, investigators will~     develop an Automated system for Prediction of EXtubation (APEX) that will integrate the~     software for data acquisition, signal analysis, and outcome prediction into a single~     application suitable for use by medical personnel in the Neonatal Intensive Care Unit (NICU).~     The performance of APEX will later be clinically validated in 50 additional infants~     prospectively.~   "
126634|NCT01909934|"~     This is a single-arm, open-label, multicenter, phase 4 clinical trial to evaluate the~     efficacy and safety of brentuximab vedotin as a single agent in patients with relapsed or~     refractory Systemic Anaplastic Large Cell Lymphoma (SALCL).~   "
126635|NCT01909921|"~     The purpose of this study is to assess the effectiveness of a Relaxation Response~     Intervention for Depression offered to low income populations at Massachusetts General~     Hospital (MGH) - Chelsea, Revere and Charlestown health centers.~   "
126636|NCT01909908|"~     The Extracellular Matrix (ECM) and Blood Components for Wound Healing feasibility study is a~     clinical trial approved by Health Canada to study the safety of extracellular matrix (ECM)~     and autologous blood products in wound healing.~   "
126637|NCT01909895|"~     Study aims and hypotheses are as follows:~      Primary Hypotheses:~      Compared to the neutral condition, the anger recall task will acutely induce endothelial~     dysfunction by impairing endothelium-dependent arterial vasodilation (Hypothesis 1a);~     increasing circulating levels of EC-derived microparticles (EMPs), a marker of EC injury~     (Hypothesis 1b); and reducing circulating levels of bone marrow-derived endothelial~     progenitor cells (EPCs), a marker of EC reparative capacity (Hypothesis 1c).~      Secondary Hypotheses:~      Compared to the neutral condition, the depressed mood and separately the anxiety recall tasks~     will acutely impair endothelium-dependent arterial vasodilation, increase circulating levels~     of EMPs, and reduce circulating levels of bone marrow-derived EPCs. There will be a relation~     of the level of self-reported anger, depressed mood, and anxiety with endothelial~     dysfunction.~   "
126638|NCT01909882|"~     The effect of family member's massage therapy on the Vital signs and Glasgow Coma Scale Score~     of hospitalized patients in Intensive Care Unit: A Triple-blinded Randomized controlled~     Clinical Trial Study~   "
126639|NCT01909869|"~     One of the purpose of this study is to assess the preliminary safety and feasibility,and to~     provide related information and evidence for the design of the further pivotal randomized~     control trial.the other purpose is to assess the performace of the stent delivery system.~   "
126640|NCT01909856|"~     This study is to assess the efficacy and safety of palonosetron in preventing the acute and~     delayed emesis induced by 3-day highly emetogenic chemotherapy. A double-blind, crossover~     design is used and granisetron is the positive control.~   "
126641|NCT01909843|"~     This is a Phase I, single-centre, open label study to evaluate the occurrence and subsequent~     reversibility and prevention, of bronchoconstriction following single and repeated oral~     inhalations of ALX-0171 in adults with hyperresponsive airways.~      This phase I study is an exploratory study and serves to evaluate the occurrence and~     reversibility of bronchoconstriction upon inhalation of ALX-0171. The study is an open label~     trial with a sequential administration regimen of placebo and verum in all planned study~     subjects. Each subject will start the treatment with a single dose of ALX-0171 placebo (=~     formulation buffer) followed by escalating doses of ALX-0171 verum.~      Eventually a second administration of ALX-0171 placebo may take place at the end of the study~     (as defined per protocol).~   "
126642|NCT01909830|"~     Study Design:~      Multicenter, non randomized, open label phase II study designed to evaluate the efficacy and~     safety of Gemcitabine/Pemetrexed combination.~      Enrollment period: 18 months. Treatment period: maximum for 24 weeks for each patient (12~     cycles lasting 2 weeks).~      Total duration of the study: 24 months.~      Number of Subjects:~      Approximately 38 subjects will be enrolled on study:~      - First stage:12 patients enrolled~      If 1 or 0 responses were observed, the trial had to be terminated:~      - Second stage: an additional of 23 patients were to be enrolled. If 5 or less responses were~     observed in 35 patients, the combination would not be considered worthy of further study,~     while if 6 or more responses were observed, the combination would be considered sufficiently~     active to warrant further testing. Taking into account an invalidity rate of 5%, 38 patients~     will be needed for this step.~   "
126643|NCT01909817|"~     The investigators aim to determine whether a new method of enhancing and improving ECG~     acquisition, analysis and display is effective. The investigators will perform~     superimposition and summation of multiple standard ECG cycles, in the same lead, by temporal~     alignment to the peak R wave and voltage alignment to an improved baseline at the T-P~     segment.~   "
126644|NCT01909804|"~     The primary objectives of this study are to evaluate the antiviral efficacy, safety, and~     tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV)~     in treatment-naive adults with chronic genotype (GT) 1 or 3 hepatitis C virus (HCV)~     infection.~   "
126645|NCT01909791|"~     Although multiple studies have clearly demonstrated that ranibizumab therapy is more~     effective than laser alone for vision gain and avoiding vision loss in patients with~     central-involved Diabetic Macular Edema (DME), only eyes with poor visual acuity, such as a~     visual acuity letter score of 78 or worse (approximate Snellen equivalent of 20/32 or worse)~     were eligible. Eyes that have central-involved DME with good visual acuity (20/25 or~     better) have not been addressed systematically by recent studies for treatment of DME.~     Baseline cohort characteristics from the Early Treatment Diabetic Retinopathy Study (ETDRS)~     suggest that a substantial percentage of eyes with central-involved DME may retain good~     vision. The investigators do not know definitively whether eyes with central-involved DME and~     good vision do better with anti-VEGF (vascular endothelial growth factor) (e.g. aflibercept)~     therapy initially, or focal/grid laser treatment or observation initially followed by~     anti-VEGF only if vision worsens.~      The primary objective of the protocol is to compare the % of eyes that have lost at least 5~     letters of visual acuity at 2 years compared with baseline mean visual acuity in eyes with~     central-involved DME and good visual acuity defined as a Snellen equivalent of 20/25 or~     better (electronic-ETDRS letter score of 79 or better) that receive (1) prompt focal/grid~     photocoagulation + deferred anti-VEGF, (2) observation + deferred anti-VEGF, or (3) prompt~     anti-VEGF.~      Secondary objectives include:~        -  Comparing other visual acuity outcomes between treatment groups, such as the percent of~          eyes with at least 5, 10 and 15 letter losses in visual acuity from baseline mean visual~          acuity, percent of eyes with at least 5 letter gain in visual acuity from baseline, mean~          visual acuity, mean change in visual acuity, adjusted for baseline mean visual acuity~        -  For eyes randomized to deferred anti-VEGF, the percentage of eyes needing anti-VEGF~          treatment~        -  Comparing optical coherence tomography (OCT) outcomes, such as the mean change in OCT~          central subfield (CSF) thickness, adjusted for baseline mean thickness~        -  Comparing the number of eyes with PDR at randomization, proportion of eyes avoiding~          vitreous hemorrhage or panretinal photocoagulation (PRP) or vitrectomy for PDR between~          treatment groups~        -  Comparing safety outcomes between treatment groups~        -  Comparing associated treatment and follow-up exam costs between treatment groups~   "
126646|NCT01909778|"~     This trial was intended to investigate the pharmacokinetics, safety and tolerability of BI~     201335 NA soft-gel capsules in patients with compensated liver cirrhosis, i.e. grade A~     according to Child-Pugh classification (< 7 points).~   "
126647|NCT01909765|"~     To compare the effect of two different surgical techniques, the dorsal slit and double~     incision technique, on postoperative pain.~   "
126648|NCT01909752|"~     This study will test an investigational vaccine, called DRibbles, for the treatment of~     non-small cell lung cancer (NSCLC). We hypothesize that vaccination with the DRibble vaccine~     will cause an immune responses against proteins contained in the DRibble vaccine and the~     protein antigens targeted by this strong immune response will include common antigens shared~     by both the vaccine and the patient's tumor.~   "
126649|NCT01909739|"~     The aim of this study is to examine the association between preoperative statin treatment and~     the incidence of postoperative acute kidney injury(AKI) in patients undergoing valvular heart~     surgery.~   "
126650|NCT01909726|"~     The purpose of this study is to test the hypothesis that providing low-intensity~     opportunities for interactive play can improve the waiting and overall clinic experiences of~     children. This study evaluates an innovative, interactive system called ScreenPlay designed~     to realize the intentions of the Healing Environment in the waiting space of a paediatric~     hospital.~   "
126651|NCT01909713|"~     The purpose of this study is to determine the tolerability of Cetaphil® DermaControl™ Foam~     Wash and Moisturizer SPF 30 in pediatric subjects (7-11) with acne prone skin.~   "
126652|NCT01909700|"~     Objectives: To evaluate whether the use of single incision un-anchored small mesh implants is~     feasible, safe and effective for women with moderate pelvic organ prolapse.~      Design: Patients diagnosed with moderate pelvic organ prolapse were enrolled to undergo a~     single incision un-anchored mesh operation. Follow-up was 4 to 23 months. The outcome~     measures for this study were the operative safety and post-operative pain, adverse effects~     and anatomical as well as functional cure.~      Setting: The operations were performed under general anesthesia according with the reported~     surgical techniques at university and private hospitals.~   "
126653|NCT01909687|"~     System accuracy evaluation of different blood glucose monitoring systems with 3 lots of test~     strips per systems according to ISO 15197:2013~   "
126654|NCT01909674|"~     Our group previously conducted a study looking at the performance of three styles of positive~     airway pressure masks during laboratory treatment studies for obstructive sleep apnea, and we~     found that patients using a full-mask mask required higher positive airway pressures than~     patients using nasal or nasal pillows style masks to achieve successful reduction of~     respiratory events. In the current study we want to randomly assign patients to either nasal~     or full-face masks and then switch to a different mask (if nasal was originally chosen than~     the mask will be switched to full-face and vise versa) after 3-weeks of use to see if the~     number of respiratory events change with the different mask style. We expect the number of~     respiratory events will increase with the use of full-face masks.~   "
126655|NCT01909661|"~     The objective of this double blinded randomized study is to assess the tolerance of two~     extensively protein hydrolyzed infant formulas, one based on rice protein and the other one~     on casein, at introduction, and after 3 months of consumption, and their efficacy on growth~     and on the reduction of allergy symptoms through a 3 months consumption period.~   "
126656|NCT01909648|"~     The study is designed to demonstrate HbA2 Leuven mutation and to asssess its impact on~     routine HbA1c measurements.~   "
126657|NCT01909635|"~     Kelsey Wallour and Dr. Hollie Raynor are doing a study to investigate the effect of focusing~     on certain thoughts and feelings during a meal on liking of items in the meal. A total of 36~     women are anticipated to participate in this study.~   "
126672|NCT01909440|"~     This randomized pilot clinical trial studies resistance training and protein supplementation~     in increasing lean body mass in patients with prostate cancer receiving androgen deprivation~     therapy. Resistance training and protein supplementation may help improve quality of life in~     patients with prostate cancer receiving androgen deprivation therapy.~   "
126673|NCT01909427|"~     The purpose of this study is to assess the efficacy and safety of CNTO6785 in participants~     with active rheumatoid arthritis (RA) despite methotrexate (MTX) therapy.~   "
126674|NCT01909414|"~     The purpose of this study is to evaluate the safety of two HIV vaccines in HIV-1-infected~     young adults who are taking anti-HIV medications and have very low virus levels. This study~     will also look at how the immune system responds to the vaccines.~   "
126658|NCT01909622|"~     Prevalence of VDD is high worldwide, even in sunbathed equatorial regions where it had not~     been suspected before. The most cost-effective method for reducing population-wide VDD is~     through fortification of commonly consumed foods. Nevertheless, the efficacy of fortification~     varies by dose, duration, and population characteristics; and it is currently unknown whether~     it could be an efficacious public health intervention to curb the VDD epidemic among children~     living in tropical areas. We propose to conduct a randomized, controlled, double blind trial~     to assess the effect of vitamin D3 fortification of milk on serum 25-hydroxyvitamin D~     concentrations in school-age children and their mothers in Bogotá, Colombia. Eighty families~     with a child participating in an ongoing cohort study will be randomized to receive one liter~     per day of either skim milk fortified with 600 IU vitamin D3 per 250mL or unfortified skim~     milk for a six-week period. Caregivers will be instructed to give the index child two cups of~     milk per day and to distribute the remaining milk to the rest of the family. We will measure~     serum 25(OH)D concentrations of the children and mothers at baseline and at the end of the~     intervention period.~   "
126659|NCT01909609|"~     The American Academy of Pediatrics changed their stance on circumcision to health benefits~     of newborn male circumcision outweigh the risks and that the procedure's benefits justify~     access to this procedure for families who choose it (AAP, 2012).~      We wonder if parents are aware of guidelines such as those of the AAP. Are parents able to~     make this medical decision by weighing the risks against the benefits of circumcision, or do~     they simply use sociocultural/religious reasons to make this decision? We hypothesize that~     parents are unaware of the specific benefits and risks of circumcision, and make this~     decision based primarily on sociocultural, religious, and/or familial norms.~      Expectant parents' knowledge will be assessed via a Qualtrics survey. Participants will be~     recruited in the OB/GYN clinic sometime between their 24-28 week prenatal visit. We hope to~     accrue at least 680 participants for this study in order to achieve statistical significance~     and acquire a range of demographics. Expectant mothers and fathers (and single mothers) will~     be encouraged to participate.~      This survey will assess their desire to get their child circumcised when they are born.~     Participants will be asked to list perceived risks and benefits of circumcision. This will~     hopefully allow us to see two things: if parents are aware and knowledgeable of the risks and~     benefits or circumcision, and what they perceive to be risky or beneficial from a medical~     standpoint.~      Parents will be randomly given 1 of 2 pieces of information (1 per couple [or per single~     mother]; 1 control, 1 experiment) with different information about circumcision. We will see~     if there are any outcome differences based on which group the couple randomized into.~     Follow-up phone call will serve to assess outcome if baby was circumcised and any factors~     that led up to the decision. This will allow us to see if the AAP stance has any effect on~     decision making when we compare the control and experiment groups.~   "
126660|NCT01909596|"~     The purpose of this is to test lateral foot orthoses with different amount of wedging to find~     a model that predicts the optimal lateral inclination of foot orthosis based on biomechanical~     or feelings measures. This study was a cross-sectional study with patients serving as their~     own control. The investigators recruited 24 knee osteoarthritis. Knee radiography and~     clinical angles measures was carried out before making orthoses, then motion analysis with an~     optoelectronic system was performed with each pair of foot orthoses. During motion analysis,~     five gait trials were carried out in each condition.~   "
126661|NCT01909583|"~     We have developed a pre-operative educational / counselling booklet with the focus on~     informing parents / patients about the different stages before, during, and after cardiac~     surgery that they will encounter; both chronologically and emotionally. With this approach~     and study our objectives are:~      1. To provide anticipatory guidance for parents to decrease parental stress and improve~     parental experience and preparedness, thus involving the parent as a partner in caring for~     their child.~      We hypothesize that this additional tool will improve parental satisfaction in regards to~     being prepared for their child's heart surgery.~   "
126662|NCT01909570|"~     The purpose of this study is to determine whether a policy of elective single embryo transfer~     (eSET) plus single embryo cryotransfer is as effective as a double embryo transfer in terms~     of clinical pregnancy rate~   "
126663|NCT01909557|"~     To assess the effects of Acetyl-L-Carnitine, probiotics and antioxidant nutritional~     substances administration on work productivity, daily activity, and fatigue in subjects with~     chronic hepatitis C treated with Pegylated-Interferon-α2b and Ribavirin.~   "
126664|NCT01909544|"~     The purpose of this study is to investigate whether a localized exercise, in which~     cardiorespiratory demand is reduced, will result in greater limb muscle fatigue in patients~     with COPD as a consequence of muscle oxygenation and muscle metabolism disturbances.~   "
126665|NCT01909531|"~     The primary goal of this study is to evaluate and compare outcomes, trends, and effectiveness~     of both awake and asleep Deep Brain Stimulation (DBS) surgical treatments, target selection,~     targeting accuracy and outcomes in patients with Parkinson's disease and Essential tremor.~   "
126666|NCT01909518|"~     The aim of the present study：~        1. To investigate the diagnosing value of pCLE for early esophageal squamous neoplasia.~        2. To assess the detection rate of early esophageal squamous neoplasia by virtual~          chromoendoscopy~   "
126667|NCT01909505|"~     Low testosterone is a common male problem. The diagnosis of low testosterone often requires~     blood sampling and expensive testing. We want to know if measuring saliva testosterone can be~     used in place of blood sampling. Study participants will be asked to provide samples of blood~     and saliva for the measurement of testosterone. These results may lead to the development of~     a saliva test for testosterone.~   "
126668|NCT01909492|"~     This study will evaluate relaxin (RLX) levels in patients with multiple sclerosis.~   "
126669|NCT01909479|"~     This will be a randomized, double-blind, placebo-controlled, parallel-group, multicenter~     study in adult subjects with GHD to assess the safety and efficacy of a long-acting, once~     weekly injection of modified hGH (MOD-4023).~   "
126670|NCT01909466|"~     To determine the safety and tolerability of multiple-dose administrations of aripiprazole~     intramuscular (IM) depot in the deltoid muscle in adult subjects with schizophrenia~   "
126671|NCT01909453|"~     This is 2-part, randomized, open label, multi-center, parallel group, phase III study~     comparing the efficacy and safety of LGX818 plus MEK162 to vemurafenib and LGX818 monotherapy~     in patients with locally advanced unresectable or metastatic melanoma with BRAF V600~     mutation. A total of approximately 900 patients will be randomized.~      Part 1:~      Patients will be randomized in a 1:1:1 ratio to one of 3 treatment arms:~        1. LGX818 450 mg QD plus MEK162 45 mg BID (denoted as Combo 450 arm)~        2. LGX818 300 mg QD monotherapy (denoted as LGX818 arm) or~        3. vemurafenib 960 mg BID (denoted as vemurafenib arm)~      Part 2:~      Patients will be randomized in a 3:1 ratio to one of the 2 treatment arms:~        1. LGX818 300 mg QD plus MEK162 45 mg BID (denoted as Combo 300 arm) or~        2. LGX818 300 mg QD monotherapy (denoted as LGX818 arm)~   "
126675|NCT01909401|"~     Currently, there is no treatment standard for use of anti-HCV (hepatitic C virus) medications~     for those preparing for a liver transplant. The purpose of this study is to determine whether~     those individuals who require liver transplantation for Hepatitis C, genotype I, who are~     undergoing liver transplantation may successfully get rid of their virus before the~     transplant by taking three medicines, peginterferon, ribavirin, and boceprevir, up until the~     time of the liver transplant surgery. If successful, the Hepatitis C virus will not re-infect~     the new liver that they receive and they will not require therapy for Hepatitis C after liver~     transplantation. This study involves the use of peginterferon alfa-2b, ribavirin, and~     boceprevir, all of which are approved for the treatment of genotype I Hepatitis C.~      Hypothesis: The addition of boceprevir to peginterferon alfa-2b and ribavirin in patients~     with Hepatitis C genotype 1 with or without hepatocellular carcinoma undergoing orthotopic~     liver transplantation will lead to rapid HCV RNA clearance of genotype I infected~     individuals. Transplantation with anhepatic boceprevir will prevent reinfection of the new~     transplanted graft and prevent graft infection posttransplantation.~   "
126676|NCT01909388|"~     The Magnetic Resonance (MR) provides high resolution of soft tissue images allowing an~     appropriate assessment of the local extent of the disease. Recent studies have shown an~     increase in sensitivity and specificity for the detection of Dominant intraprostatic lesions~     when using multiparametric MRI as a diagnostic tool in the staging of the disease.~      Among the various irradiation techniques currently available for prostate cancer,~     Brachytherapy is the superior in terms of dose conformation; this conformation allows greater~     dose escalation, adjusting the isodoses to the prostate with exquisite accuracy, keeping~     healthy adjacent organs, such as the urethra and rectum, in a tolerable dose range~      Brachytherapy companies have recently developed software allowing for TRUS-MR image fusion.~      The purpose of this study is to demonstrate the feasibility of the delivery of a higher than~     prescription dose to the dominant intra-prostatic nodule as defined on multiparametric MRI.~      Dose to prostate, and adjacent structure will remain the same as the current treatment~     practice. Timing and the delivery of brachytherapy will not change from our current practice~   "
126677|NCT01909375|"~     The American Joint Replacement Registry is a not-for-profit 501(c)(3) organization for data~     collection and quality improvement initiatives for total hip and knee replacements. The AJRR~     is a collaborative effort supported by the American Academy of Orthopaedic Surgeons (AAOS),~     the American Association of Hip and Knee Surgeons (AAHKS), The Hip Society, The Knee Society,~     hospitals, health insurers, medical device manufacturers, and contributions from individual~     orthopaedic surgeons.~   "
126678|NCT01909362|"~     Patients are being asked to participate in this study who have colorectal cancer that has~     come back after initial treatment. The investigators want to improve treatment in patients~     with this disease. In other types of cancers, it has been possible to improve treatment by~     studying the gene mutations (called biomarkers) in a patient's cancer and matching these to~     existing cancer therapies or study drugs which target that specific mutation. Colorectal~     cancers have not been routinely tested in this way.~      In this study, investigators will determine whether mutational testing can be successfully~     done on colorectal cancers and how often mutations are detected for which there are existing~     drugs (or drugs in development). The results will be used to determine if treating physicians~     use this information in planning subsequent treatment.~   "
126679|NCT01909349|"~     Persons undergoing cardiac rehabilitation often have difficulties transferring the learned~     health behaviors into their daily routine which decreases their health status. Computer-based~     tailored interventions have been shown to be effective in increasing physical activity as~     well as fruit and vegetable consumption. The aim of this study is, to support people in~     transferring these two learned behavior changes and their antecedents into their daily life~     after cardiac rehabilitation in Germany, the Netherlands and China. The primary goal of the~     study is to analyze the effectiveness of a rehabilitation aftercare program with regard to~     the level of physical activity and nutrition.~   "
126680|NCT01909336|"~     The purpose of this study is to determine if isotonic solutions reduce the risk of hospital~     acquired hyponatremia compared with hypotonic solutions.~   "
126681|NCT01909323|"~     Digestive symptoms following consumption of low digestibe carbohydrates are generally~     assessed product by product but several ingredients can be used simultaneously. The study~     aimed at evaluating to digestive tolerance of maltitol and FOS used in a same food.~   "
126682|NCT01909310|"~     After routine induction of general anaesthesia peak airway pressure (= P max) and other~     respiratory parameters(i.e. expiratory tidal volume, expiratory CO2) are measured with and~     without head support in three different head positions: neutral position, reclination of the~     head, a position deemed ideal by the anaesthesist; primary study goal is pmax depending on~     different head positions;~   "
126683|NCT01909297|"~     The investigators aimed to compare of the i-gel, supreme and proseal laryngeal mask airways~     in paralysed patients undergoing gynaecological laparoscopic surgery with oropharyngeal leak~     pressure. The investigators also studied their relative ease of insertion, time to insertion~     and complications of use as secondary outcome measures.~   "
126684|NCT01909284|"~     This study is being conducted to investigate the effectiveness and safety of acupuncture for~     alleviating pain of spondylosis.~   "
126694|NCT01909141|"~     Polycystic ovary syndrome (PCOS) affects 5-10% of women in childbearing age. Hyperinsulinemia~     contributes to chronic anovulation commonly encountered in women with PCOS. The first choice~     therapy is clomiphene citrate (CC). In CC resistant cases, the American College of Obstetrics~     and Gynecology (ACOG) recommends the use of insulin sensitizer metformin. Other insulin~     sensitizing agents include rosiglitazone and pioglitazone. Pioglitazone is said to improve~     fertility and ovulation in patients with PCOS.CC may be associated with poor endometrial~     thickening due to its antiestrogenic effect. Letrozole may improve this condition. In this~     study we will compare the effect of combined letrozole-metformin-pioglitazone with that of~     combined CC-metformin-pioglitazone in ovulation induction in CC-resistant PCOS women.~   "
126695|NCT01909128|"~     The respiratory and gastrointestinal infections are a very common problem with high morbidity~     in children. These conditions were due, in general, immaturity and all inexperience of the~     immune system, as well as to the particular anatomical structure and function of the~     respiratory and gastrointestinal tract still developing. This inevitably means that~     school-age children develop disease (as a result of infection) more easily than at later~     ages. The frequency and duration of these conditions implies a high discomfort and incur~     significant costs in relation to drug administration, the need for hospitalization, days of~     absence from school and work days lost by parents.~      Recently probiotics, defined as microorganisms that prove able, once ingested in adequate~     amounts, exert beneficial functions for the body have been proposed for the treatment of~     treatment of respiratory and gastrointestinal infections of childhood but only in recent~     years have been conducted controlled clinical trials that have conclusively proven~     effectiveness. All probiotics induce an immune response, the characteristics of which are~     related to the strain or the mixture of bacteria used. Recent studies have demonstrated~     positive effects of probiotics on the respiratory system, and in particular on the prevention~     and reduction of the severity of respiratory infections, probably mediated by an increase of~     cells that secrete Immunoglobulin A in bronchial mucosa. It 'been shown that probiotics can~     be a sure way to reduce the risk of early acute otitis media and the use of antibiotics for~     recurrent respiratory infections during the first year of life. Similar results were seen in~     a study conducted on a population of 326 children aged between 3 and 5 years, who found a~     decrease in the incidence of antibiotic use by over 65% and a reduction of days of absence of~     more than 25% among children treated with a probiotic. Many of the studied effects of~     probiotics, understandably, refer to the digestive system. These effects relate to both~     conditions paraphysiological (constipation) and more specifically in situations of illness.~      Most of the studies carried out in recent years has demonstrated the efficacy of specific~     probiotics in reducing the symptoms in the pediatric population affected by infectious~     gastroenteritis. Probiotics reduce the duration of infectious diarrhea by 0.7 days and reduce~     the frequency of diarrheal episodes in the first few hours.~      The microbiota on the other hand participates in the function of the mucosal barrier against~     the adhesion of pathogenic bacteria, crucial time for the start of the infectious process.~      When this barrier function is altered by chemical agents, by antigens or by stressors of~     different nature, may manifest intestinal disorders, sometimes due to the growth of bacteria~     pathogens. Numerous experimental data suggest that probiotics can contribute to the~     reinforcement of the activities of gut mucosal barrier, in particular aspects affecting the~     functionality of the intestinal epithelial cells or macrophages.~      More recently it has been shown that daily intake for 3 months of preparation with probiotics~     reduce the incidence and severity of the most common respiratory infections and limits the~     number of days of absence school children during the winter season.~      It's scientifically recognized as some probiotic effects can also be obtained with the use of~     inactivated bacteria or bacterial components isolated (eg bacterial DNA). It has been~     recently proposed a modified definition of probiotic products as prepared bacterial cells or~     bacterial components that have a beneficial effect on the health and welfare of the host.~      Among these products probiotic-like fall ingredients object of this study: food ingredients~     (rice flour and skim milk) fermented, or in which has been made to grow a probiotic~     (Lactobacillus CBA-L74) that has been inactivated at the end of the fermentation process~     through a heat treatment. The benefits are attributable to bacterial components that remain~     in the final product (for example, DNA, cell wall, etc.) and factors produced during the~     fermentation (short chain fatty acids, bacterial proteins, etc.).~      The main effects of these bacterial components relate to the stimulation of the~     gastrointestinal tract associated lymphoid tissue (GALT), through interaction with the immune~     cells via Toll-like receptors.~      In addition, some components, such as proteins and peptides, may have a Bifidogenic activity~     and are available in the literature some studies that have demonstrated the ability of infant~     formula, milk-based fermented to reduce the severity of episodes of infectious diarrhea in~     children.~      With this data, the Commission of the European Society of Nutrition Gastroenterology,~     Hepatology and Pediatric Nutrition (ESPGHAN) has defined this type of products are not only~     safe but to determine a potential prebiotic effect and the reduction of the severity of~     episodes of infectious diarrhea.~   "
126815|NCT01907555|"~     This project will make it possible to better understand the natural history of Cohen Syndrom~     and the phenotypes associated with mutations in the VPS13B gene, to improve the therapeutic~     management of patients. It will also provide a better description of Cohen-like syndrome for~     genetic counselling for the families concerned.~   "
126685|NCT01909271|"~     Stroke is the leading cause of adult disability and costs U.S. taxpayers >$60 billion~     annually. Interventions designed to educate patients to seek treatment sooner when a stroke~     occurs may increase low rates of treatment with thrombolysis (current rates 3% national~     average). Thrombolysis can increase the odds of minimal to zero disability from stroke if~     emergency medical system response times and in-hospital response times are optimized (maximum~     time from symptom onset to intravenous thrombolysis is 4.5 hours). Black and Hispanic~     Americans have higher stroke incidence compared to Whites and are less likely to receive~     thrombolysis for acute stroke. The latency to hospital arrival is largely dependent on~     patients'recognition of stroke symptoms, and immediate presentation to the emergency~     department. Our group has found very low stroke literacy rates among Blacks and Hispanics~     compared to Whites, which may, in part, be responsible for disparities in acute stroke~     treatment. Building on our previous work, in which the investigators have identified barriers~     to increasing stroke literacy and behavioral intent to call 911, the investigators will~     develop and evaluate the effectiveness of a novel, culturally tailored intervention using~     storytelling (narrative persuasion) in the form of two professionally produced 12-min films~     (in English and Spanish), in minority populations in New York City. The investigators~     hypothesize that participants in the intervention arm (who view the stroke education film)~     will demonstrate greater behavioral intent to call 911 for suspected stroke compared to those~     in the usual care arm, who will receive written stroke education materials. Behavioral intent~     to call 911 will be assessed immediately after viewing the film, 6 months later, and one year~     later.~   "
126686|NCT01909258|"~     The main objective of this study is to describe for the first time the expansion reserve of~     the pelvic area (measurements using the EOS system) for each of the four morphotypes~     (Roussouly classification) commonly found in a population of healthy volunteers.~   "
126687|NCT01909245|"~     City of Hope National Medical Center, located in Duarte, CA, is hosting a clinical study on~     islet cell transplantation, an experimental procedure being evaluated as a treatment for~     patients with type 1 diabetes. Islet cell transplantation involves taking insulin-producing~     cells from organ donors and transplanting them into the liver of a patient with diabetes.~     Once transplanted, the islets produce insulin, which can improve blood sugar control and~     eliminate the need to inject insulin or use an insulin pump.~      Anti-thymocyte globulin (ATG) is an anti-rejection medication that works by decreasing a~     patient's T-cells. T-cells are special white blood cells that recognize and destroy unwanted~     things like infections but can also attack transplanted cells and organs. Reducing the number~     of T-cells at the time of transplant is expected to protect islets and improve long-term~     transplant results. Transplant programs around the world have seen improved islet transplant~     results using T-cell depleting medications. Approximately 5-6 out of every 10 patients remain~     off insulin five years after transplant. These results are similar to those achieved with~     whole pancreas transplant without requiring major surgery, and therefore, may be an option~     for patients who are not eligible for a whole pancreas transplant.~      The purpose of this study is to determine if islet cell transplantation using ATG, along with~     additional medications to prevent the body from rejecting the transplanted cells, is a safe~     and effective treatment for type 1 diabetes. Study participants may receive up to three islet~     transplants and will be followed for five years to monitor blood sugar control, islet~     transplant function, and changes in quality of life.~   "
126688|NCT01909232|"~     The purpose of this study is to determine whether the Cervel Neurotech rTMS device is safe~     and effective in the treatment of depression in people who do not get better with~     antidepressant medications or cannot take antidepressant medications.~   "
126689|NCT01909219|"~     This is an endoscopist-blinded, prospective, multicenter study involving adult outpatients~     aiming at evaluating whether sodium picosulphate/magnesium citrate split dosing is associated~     to higher efficacy and acceptability in comparison to the standard dose regimen in bowel~     cleansing before colonoscopy~   "
126690|NCT01909193|"~     Adults with Social Anxiety Disorder will be pseudo randomly assigned to either an individual~     cognitive behavior therapy, attention bias modification treatment (allocation ratio - 1.5:1).~      Outcome measures will be social anxiety symptoms and severity as measured by gold standard~     questionnaires as well as diagnosis of social anxiety disorder derived from structured~     clinical interviews based on Diagnostic and Statistical Manual (DSM) IV criteria.~      The investigators expect to find significant reduction in social anxiety symptoms in all of~     the groups, with the cognitive behavior therapy group showing greater reduction in symptoms~     than the other groups. Mechanisms of change in all of the groups will be examined via~     measures of cognitive biases, affect, and other common and specific factors.~   "
126691|NCT01909180|"~     An external evaluation to obtain clinical data to create sample clinical images.~      The data will also be used for product and technology development, marketing materials, and~     inclusion in publications.~   "
126692|NCT01909167|"~     Most depression during pregnancy is undetected and untreated although it is known to be~     harmful both to the woman herself and her future child. When these mental disorders are~     detected, psychotherapies remain difficult to access, especially in primary care, despite~     being effective.Also, prenatal depression is known to be a strong risk factor for postnatal~     depression and may prejudice the mother-infant relationship. This leads us to the following~     question: Will individual Cognitive Behavioral Therapy (CBT) delivered online be a more~     effective treatment for symptoms of depression in pregnant women, than treatment as usual~     (TAU)?~      The proposed randomized controlled trial aims at evaluating the efficacy of internet based~     cognitive behavioural therapy(CBT) delivered individually via skype, using video and audio~     resources, by a fully trained psychotherapist, compared to treatment as usual, in women~     suffering from symptoms of depression in pregnancy.~      Hypothesis The internet based interventions will be more effective at reducing symptoms of~     depression in pregnant women than treatment as usual, in terms of rates of diagnoses and~     levels of self rated symptoms of depression.~   "
126693|NCT01909154|"~     The purpose of this study is to confirm the security, and detect the effect of the local~     administration in damaged nervous tissue, of autologous bone marrow stromal cells.~   "
126718|NCT01908829|"~     The purpose of this study was to see if adding a new type of medication recently approved to~     treat overactive bladder (mirabegron) to an antimuscarinic treatment (solifenacin) would be~     more effective in controlling incontinence than when using the antimuscarinic treatment~     alone.~   "
126696|NCT01909115|"~     Vitamin D deficiency is common in the general population and more common in children with~     chronic kidney disease. Vitamin D is very important for bone health, especially in children~     with chronic kidney disease. To date, several studies using different doses of vitamin D have~     been tried to correct vitamin D deficiency, but none has been completely successful. The~     investigators are comparing two different doses of vitamin D to determine which one is more~     effective at correcting and maintaining normal blood levels of vitamin D. The investigators~     hypothesize that a higher percentage of children receiving a higher dose of vitamin D will be~     vitamin D replete at the end of 6 months.~      This study will enroll 80 children 9 to 18 years old who have chronic kidney disease and can~     take pills. They will be enrolled from Chronic Renal Insufficiency Clinic, the Hemodialysis~     Unit, Peritoneal Dialysis Clinic and Transplant Clinic at Children's Healthcare of Atlanta.~      After the investigators obtain informed consent and assent, children will be randomly~     assigned to either low dose (1000 units daily) or high dose (4000 units daily) vitamin D~     pills (50% in each group). Patients will be in this study for 6 months. They will take~     vitamin D pills for 6 months. Vitamin D levels will be obtained at baseline, 3 months and 6~     months. The study visits will be at the same time as routine clinic visits when the children~     are having blood drawn for routine care. At the end of the study, the investigators will~     compare the percentage of patients who have normal vitamin D levels at 6 months in the two~     groups. The investigators will also describe the percentage of patients who have elevated or~     low levels of trace elements.~      The two doses of vitamin D in this study are within the dosing range recommended by the~     Institute of Medicine, and thus the investigators do not anticipate any adverse effects.~     Vitamin D toxicity could theoretically occur, and an elevated vitamin D level at 3 months~     would be an indication to withdraw a patient from the study.~   "
126697|NCT01909102|"~     The study will determine whether a brief intervention program based on Acceptance and~     Commitment Therapy can be effective for the reduction of modifiable risk factors and~     improvement of psychological well-being in patients referred to cardiac rehabilitation~   "
126698|NCT01909089|"~     Combined spinal-epidural (CSE) analgesia has become a widely accepted approach to provide~     analgesia for labour pain. Despite the increasingly widespread use of this technique, an~     optimal intrathecal drug regimen has not been established yet.~      Several investigations using local anesthetics such as Bupivacaine, Levobupivacaine and~     Ropivacaine in CSE during labour have been published. But despite the reintroduction of~     Chloroprocaine recently there haven't been any investigations about spinal chloroprocaine.~     Chloroprocaine is already a long-know drug with a beneficial pharmacodynamic/kinetic profile.~     It is known for a very quick onset of action (2 - 3 minutes), high efficacy, rapid metabolism~     by plasma cholinesterases and short half-life both in mother and fetus.~      Because of this beneficial profile, Chloroprocaine is widely used intrathecally for surgical~     anesthesia. Several investigations demonstrate that for surgical anesthesia doses~     Chloroprocaine ranging from 30 - 60 mg are used and that they have an effective surgical~     duration of 40 - 90 minutes.~      Despite these standards for surgical anesthesia, little is known about spinal~     Chloroprocaine dose regimens. Therefore the primary goal of this study is to determine the~     minimum adequate dose of Chloroprocaine that is to be given spinally to a woman in labour~     using a CSE procedure. We will use the up-down sequential allocation to identify the median~     effective dose (ED50) or concentration (EC50).~      The Effective dose in 95% of the population (ED95) can be estimated also from an up-down~     sequential allocation and will become an important valuable approximation of the clinical~     dose.~   "
126699|NCT01909076|"~     Prescription opioid misuse is a significant public health problem as well as a patient safety~     concern. Primary care providers are the leading prescribers of opioids for chronic pain, yet~     few providers follow standard practice guidelines regarding assessment and monitoring. The~     investigators propose a novel system change in delivery of primary care services to decrease~     misuse of and addiction to prescription opioids for patients with chronic pain.~      The proposed intervention for the overall project includes a nurse-managed registry for~     planning individual patient care and conducting population-based care for a population of~     patients receiving opioids for chronic pain. Academic detailing to clinicians is another~     effective way to improve care. Finally, the researchers will create a knowledge management~     tool to facilitate guideline adherence. This tool will be accessible via an internet link,~     and will include validated instruments to assess patient status and also to facilitate~     physician adherence to suggested monitoring.~   "
126700|NCT01909063|"~     The goal of this investigator-initiated study is to determine whether the fortification of~     orange juice with vitamin D, vitamin A, and vitamin E will enhance the vitamin D, vitamin A,~     and vitamin E status children ages 6-10 that are seen at the Division of Pediatrics at Boston~     University Medical Center. Circulating concentrations of 25-hydroxyvitamin D [25(OH)D],~     vitamin A, and vitamin E before, will be measured at mid-intervention (week 6), and after a~     period of twelve weeks. This study plans to recruit 180 male and female subjects between the~     ages of 6 and 10. An informed consent will be explained and discussed with the subjects and~     their parents/guardians willing to participate in the study. The study will be twelve weeks.~     Blood will be drawn during the initial visit, mid-intervention (week 6), and week 12. Dietary~     intake will be assessed at baseline and at the conclusion of the 12-week intervention using a~     3-day food record. The subjects will be randomized in a double-blinded manner via an~     electronically shuffled listed. Subjects will be randomized to receive one of three~     beverages: (1) calcium plus vitamin D fortified orange juice (intervention A), (2) calcium~     plus vitamins D, A, and E fortified orange juice (intervention B) or (3) calcium-only~     fortified orange juice (controls). Subjects in all groups will drink two 8-oz. glasses of~     juice at least six hours apart (morning and afternoon) per day for a period of 12 weeks.~     Subjects randomized to intervention A will receive 200 IU vitamin D and 700 mg of calcium per~     day in 2 glasses of juice, intervention B will receive 200 IU vitamin D, 12 IU vitamin E,~     2000 IU vitamin A as beta carotene, and 700 mg of calcium per day in 2 glasses of juice,~     while controls will receive 700 mg of calcium per day in 2 glasses of juice. A blood sample~     will be obtained before the subjects begin drinking the orange juice and at week 12 to~     determine levels of 25(OH)D which is a measure of vitamin D status. Blood will also be used~     for determining osteocalcin, parathyroid hormone (PTH), alkaline phosphatase, phosphorus,~     calcium, C-telopeptide (CTX), albumin, vitamin A, and vitamin E. A blood sample will also be~     obtained at week 6 for 25(OH)D and PTH.~   "
126701|NCT01909050|"~     The main purpose of this study is to see how cells taken from the lining of the intestine~     behave in the laboratory with exposure to gluten and other substances that act on the immune~     system. The cells lining the intestine of a person with celiac disease should be different~     than a person without celiac disease. The study doctors would like to see how the cells react~     after coming in contact with gluten and if substances that act on the immune system can~     prevent gluten related inflammation. Examples of these substances include steroids. The cells~     should produce chemicals of their own in response to the gluten. These other chemicals will~     be measured and the results compared between those with:~        -  celiac disease that does not respond to a gluten-free diet (refractory celiac disease)~        -  celiac disease which is controlled by a gluten-free diet~        -  uncontrolled celiac disease (either newly diagnosed with celiac disease or not on a~          gluten-free diet~        -  gluten-sensitivity~        -  disorders other than celiac disease.~   "
126702|NCT01909037|"~     The purpose of this study is to evaluate the efficacy of bio-optimized curcumin(Flexofytol)~     during a 90-days period in knee ostearthritis patients on the serum levels of specific~     biomarkers of osteoarthritis and on the evaluation of pain.~   "
126703|NCT01909024|"~     The aim of this study is to identify whether the treatment of pelvic venous reflux (pelvic~     embolisation) in females with recurrent leg varicose veins, who have a proven contribution to~     their leg varicose veins from pelvic venous reflux, have a reduction in future recurrence~     after endovenous laser treatment for recurrent varicose veins in the legs.~   "
126704|NCT01909011|"~     The purpose of this study is to assess the antidepressant effects of Cranial Electrotherapy~     Stimulation (CES) in the depressed phase of bipolar II disorder.; to examine the safety of~     daily CES in bipolar II patients; and to examine the effects of 20 minutes of daily CES on~     EEG reading.~      The investigators hypothesize:~        1. The CES will reduce symptom severity more than sham (placebo) CES.~        2. That CES administered for 20 minutes daily for four weeks is safe and well tolerated~          when treating bipolar II patients.~        3. That CES will shift the alpha and beta power fractions of EEG downward, and that this~          shift correlates with a decrease in level of anxiety and depression~   "
126705|NCT01908998|"~     The Y-balance test is a lower extremity, dynamic test performed in single limb stance that~     measures a person's ability to reach in 3 directions. The test is typically conducted in~     barefoot. The purpose of this study is to assess the impact of footwear on Y-Balance test~     scores. The investigators hypothesize that by improving alignment and augmenting muscle~     mechanics, sandals with medial arch support may improve Y-Balance scores.~   "
126706|NCT01908985|"~     Monocentric prospective study conducted in two phases evaluating the secretion and~     elimination of aqueous humor by fluorophotometry in patients with glaucoma treated with~     cyclo-coagulation with ultrasound.~      Population selected:~      - Patients with refractory open angle glaucoma despite previous treatments currently~     validated for glaucoma.~      The purpose of our study is:~      - To evaluate the mechanism of action of glaucoma treatment by cyclo-coagulation with high~     intensity focused ultrasound in studying the secretion and elimination of aqueous humor by~     fluorophotometry.~      Planning:~        -  First phase: 2 patients (feasibility study) If reduction of at least 10% of the flow of~          aqueous humor production at one month in the first two patients in the feasibility~          study, further in second phase.~        -  Second phase: 6 patients~   "
126707|NCT01908972|"~     The purpose of this study is to determine the safety and efficiency of Propranolol as an~     initial treatment for pediatric hemangioma.~   "
126708|NCT01908959|"~     The purpose of Madres Para la Salud [Mothers for Their Health] is to see how support and~     encouragement can help women to make positive changes in their health. This program tested if~     supportive information, encouragement, and walking as a group would increase physical~     activity and health benefits, such as weight loss and postpartum depression.~      Participants in this study were randomly assigned to one of two groups, a walking or a~     non-walking group. The walking group met weekly. Participants were given a pedometer to~     record the number of steps taken daily.~      Participants met one time each week with our study staff. Participants walked four other days~     per week on their own, or with other group members. Participants measurements included body~     fat, waist, and hip at the beginning of the study, and at 3, 6, 9, and 12 months. The~     non-walking group received a weekly mailed newsletter about topics such as parenting, infant~     growth and development, and reproductive health. Non-walking group participants' measurements~     included body fat, waist, and hip at the beginning of the study and at 6 and 12 months.~   "
126709|NCT01908946|"~     The investigators plan to test the effectiveness of reminders to parents/guardians on cell~     phones through short messaging system (SMS) in improving the on-time routine immunization for~     children in Pakistan. SMS message as a reminder tool can be very effective in health care~     settings at public health scale. This study will be conducted in an urban- squatter~     settlement area, Ibrahim Haidry union council in Karachi. Parents/guardians of children~     randomized in intervention arm will be sent SMS reminders vaccination visit reminders at 6,~     10 and 14 weeks of life.~   "
126710|NCT01908933|"~     The purpose of this study is to prospectively evaluate the safety and efficacy of the~     AeriSeal System in patients with advanced Non-Upper Lobe Predominant Heterogeneous Emphysema.~   "
126711|NCT01908920|"~     The aim of the present study is to determine the extend to which osteopathic manipulative~     treatment (OMT) is effective on a sample of healthy subjects in changing high frequency (HF)~     parameters.~   "
126712|NCT01908907|"~     The purpose of this study is to understand if the DHA gap can be corrected by giving a~     daily dose of DHA oil to preterm babies.~      DHA is an essential omega-3 fatty acid, which means our body cannot make DHA. We have to take~     it in through our diet. DHA is important for normal brain and eye health and it may also~     decrease inflammation. This is important for premature babies because they are at a greater~     risk for getting diseases related to inflammation, especially in their lungs, eyes and~     intestines. Since DHA is so important for normal growth, you will find DHA naturally in~     breast milk and it is now added to infant formula. But the amount in breast milk and infant~     formula is about half of what your infant should expect to get in the womb (about 13-29mg per~     day in breast milk vs. 50-75mg per day in the womb). Very premature babies are at an even~     greater disadvantage because they cannot always eat very much right away and that is the only~     way they can get essential fatty acids in their body. This means premature babies are getting~     less DHA than they would in the womb and then the DHA gap continues for a longer period of~     time. This gap also comes at a time when their brain is growing most rapidly and their bodies~     need it the most. This trial is designed to see if giving DHA, even before the baby can take~     food orally, will raise his/her DHA blood levels to those of normal term babies.~   "
126713|NCT01908894|"~     The primary objective is to assess the speed of absorption of BIOD-123 and BIOD-125 and~     compare them to Humalog.~   "
126714|NCT01908881|"~     The purpose of this study is to determine whether a group intervention for primary health~     care dyads (two interacting people, in this case: mother-infant or caregiver-infant), which~     have been screened during pregnancy to be at psychosocial risk, has an impact on parental~     sensitivity.~   "
126715|NCT01908868|"~     The investigators hypothesize that conventional or EBUS-TBNA will have equal efficiency in~     diagnosing sarcoidosis when performed in conjunction with endobronchial and transbronchial~     lung biopsy.~   "
126716|NCT01908855|"~     The purpose of this study is to evaluate whether cognitive-behavioral therapy enriched with~     strategies from emotion regulation training leads to better improvement in somatic symptoms~     and comorbid problems than cognitive-behavioral therapy alone.~   "
126717|NCT01908842|"~     The purpose of this study was to assess retention in treatment after induction with~     buprenorphine/naloxone (BNX) sublingual tablets compared with generic buprenorphine and after~     stabilization with BNX sublingual tablets compared with BNX film. Secondary objectives~     included assessment of treatment effects on opioid withdrawal symptoms, opioid cravings, and~     safety.~   "
126728|NCT01908699|"~     This is a multicenter, double-blind, randomized, placebo-controlled Phase 3 study, to assess~     the efficacy and safety of BPS-314d-MR when added-on to inhaled treprostinil (Tyvaso®)in~     patients with pulmonary arterial hypertension.~      Patients new to Tyvaso, will enter a run-in period on inhaled treprostinil until 90 days of~     experience is achieved to ensure drug tolerability before enrolling in the study.~      Treatment groups consist of one active and one placebo group. Subjects will be randomly~     allocated in a 1:1 ratio to one of the two treatment groups.~   "
126729|NCT01908686|"~     The purpose of this study is to evaluate the application of an evidence-based, manualized~     treatment for children with Autism Spectrum Disorder (ASD) (Pivotal Response Treatment, PRT)~     to children ages four through six years of age with ASD. Specifically, children will be~     randomly assigned to receive either (1) 10 hours per week of intervention services, including~     two hours per week of parent education, and eight hours per week of direct~     clinician-delivered services, or (2) a treatment as usual control. Intervention will focus on~     enhancing the following developmental skills: expressive and receptive language, play, and~     social interaction. Outcome measures will address changes in the aforementioned domains~     during structured observation and standardized assessment.~   "
126730|NCT01908673|"~     Background: Depression in the elderly, also known as late life depression (LLD) is common and~     its prevalence ranges from 2 to 6% in the community. Heart Rate Variability (HRV), a~     physiological autonomic variable is reduced in LLD and this might have implications for~     cardiovascular events including death. Methods to improve HRV in LLD have not been adequately~     assessed. Automatic Self-Transcending Meditation (ASTM) is a simple yet powerful technique~     that allows the mind to become calm and peaceful. HRV biofeedback is a method of teaching~     individuals to voluntarily improve HRV and other physiological functions to a prescribed~     range.This pilot study attempts to investigate feasibility of these interventions and provide~     preliminary data regarding the effectiveness of these techniques.~      Hypothesis: ASTM and HRV biofeedback are feasible and their effectiveness for improving HRV~     in patients with LLD can be assessed.~      Methods: Participants with LLD between the ages of 66 and 80 will be randomized to either~     ASTM or HRV biofeedback after optimizing them on antidepressant therapy. Participants will~     receive training and continue practice in either of these techniques over a period of twelve~     weeks. HRV and secondary measures will be assessed pre and post at the end of study period.~      Expected Results and Significance: The investigators expect to find both techniques to be~     feasible treatments for those with LLD. Results from this pilot study will help to assess the~     potential for successful implementation of a future larger study which will evaluate the~     efficacy of these treatments for improving HRV.~   "
126731|NCT01908660|"~     The purpose of this study is to compare the liver toxicity in HIV-infected patients with~     chronic hepatitis B and/or hepatitis C, who start a new antiretroviral drug regimen, as well~     as the influence of the degree of pre-existing liver fibrosis on the incidence of liver~     toxicity.~   "
126732|NCT01908647|"~     In this randomized, controlled clinical trial, we will evaluate the effects of (1) a~     brain-training program that uses real-time neurofeedback in functional magnetic resonance~     imaging (fMRI) to allow people to learn how to gain voluntary control over activity in~     targeted brain regions and/or (2) 8 weeks of computer-based cognitive training using a~     software program (Cognitive Remediation for Brain Injury (CRBI)) versus control training~     tasks on cognitive learning and symptoms. In addition, the investigators will measure brain~     function (active and resting functional magnetic resonance imaging) and structure (high~     resolution magnetic resonance imaging) before and after treatment.~   "
126733|NCT01908634|"~     Primary objective is to evaluate the influence of matrix on the bioavailability of key~     phytochemical constituents in fruits and their subsequent effect on chronic disease risk~     factors.~   "
126734|NCT01908621|"~     The purpose of the study is to compare safety and efficacy of stem cell mobilization using~     G-CSF (filgrastim) alone vs. intermediate-dose cytosine arabinoside plus G-CSF in multiple~     myeloma patients.~   "
126735|NCT01908595|"~     This study is to evaluate the efficacy and safety for long term use of M518101 in subjects~     with plaque psoriasis.~   "
126736|NCT01908582|"~     The main purpose of this study is to determine how much evacetrapib gets into the blood~     stream and how long it takes the body to get rid of it when given with rifampin. The safety~     and tolerability of the two drugs, given together, will also be evaluated. The study will~     also look at blood cholesterol levels and levels of a hormone called cortisol before and~     after taking rifampin. Information about any side effects that may occur will also be~     collected.~      For each participant, this study will include 2 periods in fixed order. The study will last~     approximately 29 days.~   "
126737|NCT01908569|"~     The MACS technique (magnetic-activated cell sorting) is based on the usage of microbeads,~     magnetic particles with a diameter of 35 nanometers joined to the compound annexin V. Annexin~     V is a protein with a high affinity for the molecule phosphatidylserine. This system allow us~     to eliminate those spermatozoids which have begun the apoptosis and have phosphatidylserine~     residues on their membrane surface. Using this technique, the apoptotic spermatozoids will~     join the microbeads and consequently be retained in a column applying a magnetic field.~      Recent studies show the benefits of spermatozoid selection using MACS and the improvement in~     mobility, viability, DNA fragmentation and fertilization potential. It has also been observed~     an improvement in the embryo cells division rate, clinical pregnancy rates and spermatozoid~     survival after thawing. However, it is necessary to perform new clinical studies in order to~     evaluate the real potential of this technology and its safety.~      The purpose of this study is to evaluate the effect of the MACS technique on the clinical~     results of good-prognosis patients who are going through IVF/ICSI treatments in order to~     achieve a pregnancy.~      The hypothesis of this study is that the application of the MACS technique in assisted~     reproduction treatments is associated with a better embryo quality and pregnancy rates.~   "
126760|NCT01908270|"~     Women with breast cancer and breast cancer survivors are often bothered by menopausal~     symptoms to a special degree. Treatment options for those symptoms are currently limited as~     hormone replacement therapy is often prohibited. Yoga has been shown to reduce menopausal~     symptoms as well as symptoms associated with breast cancer. Therefore, this study aims to~     investigate whether a 12-week yoga intervention can reduce menopausal symptoms in women with~     breast cancer and breast cancer survivors.~   "
126738|NCT01908556|"~     Aromatase inhibitors have shown a superior efficacy compared to tamoxifen in the treatment of~     hormonal receptor positive breast cancer in postmenopausal patients.~      Side effects like osteoporosis, bone fractures and muscle/bone pain are however more frequent~     using of aromatase inhibitors compared with tamoxifen. These side effects compromise the~     patients' well being in a significant way and may favour the use of Tamoxifen in clinical~     practice.~      Furthermore there is evidence that polymorphisms in the CYP2D6 Gene might be associated with~     an improved efficacy of Tamoxifen that is equieffective to aromatase inhibitors.~      Concerning the pharmacogenetics of aromatase inhibition there are known polymorphisms of the~     CYP19A1 gene that are associated with altered peripheral sex hormone levels and altered~     prognosis in breast cancer patients. One study could even associate a polymorphism in the~     CYP19A1 gene with a prolonged time to progression in patients with metastatic breast cancer~     who have been treated with letrozol.~      Therefore the aim of this study is to identify biomarkers that could predict the efficacy of~     an adjuvant Letrozol treatment in postmenopausal breast cancer patients.~   "
126739|NCT01908543|"~     Managing iron deficiency is important for more than 1 billion individuals worldwide, to avoid~     blood transfusions, or excessive strain on vital organs that depend on iron-containing~     haemoglobin to deliver oxygen to the tissues. Iron deficiency is a particular problem for~     people with the inherited condition hereditary haemorrhagic telangiectasia (HHT). Their iron~     deficiency and anaemia results from blood losses, especially from the nose (nosebleeds, and~     they often need additional iron to replace that lost through bleeding.~      Our goal is to stratify HHT patients into high/low absorbers of iron; to define what extra~     iron they need to adjust for their current and likely future blood losses; and to work out~     how to achieve this most safely for each individual to improve their later health.~      We will test the hypothesis that informed assessment of iron intake and post absorption~     cellular profiles changes the recommendations for iron intake for HHT patients.~   "
126740|NCT01908530|"~     The purpose of the study is to assess the safety and efficacy of the Imperial College~     Microprobe Array Continuous Glucose Sensor in healthy volunteers and in subjects with type 1~     diabetes.~   "
126741|NCT01908517|"~     There has been very limited research that has looked at electronic reminders (text messages)~     and its effectiveness in adherence to vaccination among low-income minority populations.~     Results have shown that text messages, among low-income parents and adolescents who were~     identified as having a cellphone, is an effective strategy to increase the likelihood of~     adolescent vaccination adherence. Hard copy and electronic messaging reminders have also been~     proven to be effective when coupled with other prevention strategies for immunizations for~     influenza and pneumococcal pneumonia and screening for colon, breast, and cervical cancer in~     adults. Additionally, Merck and Co. recommend electronic reminders in their patient~     compliance program as a key strategy for adherence. To our knowledge, this community-based~     pilot intervention study will be the first to assess electronic reminders and HPV vaccine~     initiation and adherence among rural uninsured and Medicaid populations. The investigators~     hypothesize that adolescent whose parents who receive the intervention will be more likely to~     initiate HPV vaccination and be compliant at 3 months and at 7 months as compared to the~     control group.~   "
126742|NCT01908504|"~     The purpose of this study is to determine the benefit of using positron emission tomography~     (PET) in addition to the standard (computed tomography) CT to plan radiation therapy for~     cancer treatment. The information from the PET-CT may allow the investigators to change the~     radiation plan or the delivery of the radiation to the tumor/tumor site such as the total~     dose of radiation or the size of the area to receive further radiation. Presently the use of~     PET scans to adjust radiation therapy during radiation treatment is not standard of care and~     is being investigated in this study.~   "
126743|NCT01908491|"~     Postoperative pain management is a major problem after repair of pectus excavatum.Various~     methods of pain management have been introduced. However, the effects of continuous wound~     infusion of local anesthetics through ON-Q catheters were not well evaluated in pectus~     surgery. Therefore, we conducted prospective randomized controlled study to compare the~     effects of IV PCA and continuous wound infusion after repair of pectus excavatum.~   "
126744|NCT01908478|"~     This is a Phase I Study of veliparib (ABT-888) in combination with Gemcitabine and Intensity~     Modulated Radiation Therapy in Patients with Locally Advanced, Unresectable Pancreatic~     Cancer.~      Primary Objectives:~        -  Determine the maximum tolerable dose of veliparib in combination with gemcitabine and~          intensity modulated radiation therapy in patients with locally advanced pancreatic~          cancer.~        -  Determine the safety and toxicity of the combination of veliparib with gemcitabine and~          radiation therapy in patients with locally advanced pancreatic cancer~   "
126745|NCT01908465|"~     Purpose:~      To evaluate the efficiency of Irritable Bowel Syndrome (IBS) patients treatment with the~     H1-receptor antagonist ebastine.~      Design:~      Double blind randomized placebo controlled trial. IBS patients receive a 12-weeks treatment~     with ebastine 20mg once daily or placebo (1:1 randomization).~   "
126746|NCT01908452|"~     Objectives: The mechanisms of tardive dyskinesia (TD) remain unclear, although~     pathophysiologic theories have proposed mechanisms such as dopamine receptor~     supersensitivity, the degeneration of cholinergic striatal interneurons, γ-aminobutyric acid~     (GABA) depletion, and an excess of free radicals.~      Prior development of second generation antipsychotic agents, tardive movement disorders were~     widespread among neuroleptics treated patients. There were great expectations of the new~     novel drugs. Unfortunately, reports about tardive movement disturbances induced by these~     medications became more and more frequent, although it has been in use for less than two~     decades.~      A recent study demonstrated that schizophrenic and schizoaffective patients suffering from TD~     had the mean level of pyridoxal 5'-phosphate (PLP) below lower limit of normal range, while~     those patients without TD had normal values. At the same time, some open and double-blind~     placebo-controlled, randomized clinical studies showed that vitamin B6 was very effective in~     treatment of TD.~      Pyridoxal kinase is a key enzyme for the biosynthesis of PLP, the biologically active form of~     vitamin B6. Some publications reported that the finding of high vitamin B6 levels is~     consistent with recent reports of low levels of PLP and low activity of pyridoxal kinase. It~     may explain the functional need for high-dose vitamin B6 supplementation in subjects with TD.~      Methods: A multicenter study including 300 schizophrenia and schizoaffective subjects will be~     performed. The trial will be consisted of 2 parts: the first part a single comparison~     pyridoxal kinase plasma activity in patients with and without TD; in the second part only TD~     schizophrenia and schizoaffective patients will continue. It will be a 12-week, randomized,~     double-blind placebo-controlled trial. Vitamin B6 (1200 mg/day) or placebo capsules will be~     added to the stable ongoing antipsychotic treatment of 150 schizophrenia patients.~     Participants will be assessed at baseline and after every 2 weeks of treatment till week 12.~     Pyridoxal kinase activity will be compared between patients who positively respond to vitamin~     B6 versus non responders. In addition, PLP levels will be monitored at baseline and at the~     end of the study.~      A battery of research tools will be used for assessment of movement disorders,~     psychopathology, and side effects. The study will be performed along a period of 2 years.~   "
126747|NCT01908439|"~     The purpose of this study was to examine the validity of the measurement method based on~     observation of vibration stimulation-MUAP (motor unit action potential) (1 to 1) matching~     that helps to measure human WBV-induced muscular reflex latency and to compare these results~     with the latency determination obtained using the classical methods. The investigators'~     principle hypothesis is that the simple method is capable of determining the WBV induced~     reflex response latency as reliably as the complex methods described earlier.~      To achieve this goal, the investigators have averaged the electrical responses of the soleus~     muscle (sEMG and multi motor unit (MMU) potential) against the vertical force data obtained~     during all the six vibration frequencies tested in this study. The investigators have then~     combined all the averaged EMG data belonging to six different vibration frequencies to~     generate the 'cumulative averaged' sEMG and MMU for each subject. The investigators have also~     obtained the standard error for the cumulative averaged records which indicated the~     WBV-induced muscular reflex (WBV-IMR) latency.~   "
126748|NCT01908426|"~     The purpose of this study is to evaluate the effect of Cabozantinib (XL184) compared with~     placebo on overall survival in subjects with advanced hepatocellular carcinoma who have~     received prior sorafenib.~   "
126749|NCT01908413|"~     This is a phase I, open-label, dose-escalation study of CUDC-427 in patients with advanced or~     refractory solid tumors or lymphoma. CUDC-427 is a drug that is designed to antagonize~     proteins that prevent or interfere with cell death. The study is designed to assess the~     safety, including the maximum tolerated dose, the pharmacokinetics, and the anti-cancer~     activity of CUDC-427.~   "
126750|NCT01908400|"~     Mental retardation is a condition diagnosed before age 18 that includes below-average general~     intellectual function, and a lack of the skills necessary for daily living. Mental~     retardation affects about 1 - 3% of the population. There are many causes of mental~     retardation, but find a specific reason in only 25% of cases.Bone marrow derived stem cells~     are used in this condition to prove its safety and efficacy .~   "
126751|NCT01908387|"~     To identify the maximum tolerated dose (MTD) of oral azacitidine on different treatment~     schedules in Japanese subjects with hematological neoplasms~   "
126752|NCT01908374|"~     The primary objective of this study is to test the effects of two different fish oil products~     containing DHA and EPA by comparing the omega-3 fatty acid levels in the blood.~   "
126753|NCT01908361|"~     In the unilateral vs. bilateral hybrid rehabilitation trials, we will conduct two separate~     clinical trials: one to recruit subacute stroke patients and another to recruit chronic~     stroke patients. The two trials will have identical study designs and interventions. The~     overall goal of this research project is to provide scientific evidence of the treatment~     effects of unilateral and bilateral hybrid therapies in subacute and chronic stroke patients~     and thus to contribute to evidence-based stroke rehabilitation and translational research for~     neurorehabilitation.~   "
126754|NCT01908348|"~     This study is an open-label pilot designed to examine the dose-dependent effects of~     erythritol, a zero calorie sweetener, on endothelial function. Twenty-four subjects with type~     2 diabetes mellitus will make three study visits. At each visit, the will consume an~     orange-flavored beverage containing escalating amounts of erythritol (6, 12, and 18 grams).~     Endothelial function will be assessed before and two hours after beverage consumption.~     Endothelial function will be measured as the change in pulse amplitude in response to~     reactive hyperemia measured in the fingertip by peripheral arterial tonometry. The results~     will be used to plan a randomized, placebo-controlled study.~   "
126755|NCT01908335|"~     This dose-escalating study is to evaluate the efficacy and the safety of different doses of a~     new bio-product Pegylated Recombinant Consensus Interferon Variant Solution for Injection~     (PEG-IFN-SA) and Ribavirin（RBV） in the treatment of Chronic hepatitis C who have not been~     previously treated with Interferon(IFN) by exploring the dose-effect relationship, while~     identity the optimal dose for phase Ⅲ study. In addition, population pharmacokinetic method~     is adopted to assess the pharmacokinetic behavior, individuals / intra-individual~     variability, and the possible factors for further study.~   "
126756|NCT01908322|"~     The study aims to investigate patient characteristics of intermediate stage hepatocellular~     carcinoma patients treated with Nexavar and their distribution to different treatment groups~     as well as determining efficacy and safety parameters.~   "
126757|NCT01908309|"~     We previously demonstrated that the slope of the relationship plotting individual iodine~     loads against contrast-induced serum creatinine changes ( the load-to-damage relationship,~     LDR) characterizes the intrinsic nephrotoxicity of the contrast. Aim of the present study is~     to compare, through the assessment of the LDR slope, the intrinsic nephrotoxicity of two~     different contrast media using serum cystatin-C changes as the LDR dependent variable.~   "
126758|NCT01908296|"~     The objective of the study was to assess the effect of multiple-dose fluvoxamine on the~     pharmacokinetics of quetiapine (FK949E) in healthy adult male subjects. The safety of FK949E~     in the population was also evaluated.~   "
126759|NCT01908283|"~     Patients with inflammatory bowel disease are at increased risk for infections due to their~     baseline disease and the subsequent immunocompromising regimen. Streptococcus pneumoniae~     (pneumococcus) has a high mortality and morbidity, particularly in immunosuppressed patients.~     A polysaccharide vaccine covering 23 different serotypes of pneumococcus (PPSV23) is~     currently recommended to immunocompromised patients to reduce their risk of invasive~     pneumococcal infections (such as bacteremia, meningitis, or pneumonia). Its immunogenicity is~     however limited, both in magnitude and duration, even in healthy individuals. Several studies~     have investigated the immunogenicity of PPSV23 in patients with IBD and have reported a~     marked inhibitory effect of immunosuppressive therapy on vaccine responses.~      A pneumococcal conjugated vaccine (PCV) was originally developed to protect young children~     and demonstrated as highly effective and safe. PCV13 contains polysaccharides from thirteen~     different serotypes, conjugated to an inactivated diphtheria toxin, and has the capacity to~     induce both primary and memory responses. PCV also appears much more immunogenic than PPSV23~     in immunocompromised pediatric and adult patients. Whether some therapeutic regimens may~     nevertheless prevent the induction of protective responses by PCV13 is yet unknown.~      To date, no study has yet reported the immunogenicity / safety of PCV13 in adult IBD~     patients.~      Study's objectives~        -  Primary objective: evaluate the immunogenicity and safety profile of PCV13 immunization~          in IBD patients~        -  Secondary objective: evaluate the relative influence of treatment and disease on immune~          responses to PCV13 immunization~        -  Tertiary objective: evaluate the immunity/vulnerability against vaccine-preventable~          diseases (VZV, measles) in the IBD cohort of Switzerland (optional, depending on funds)~   "
126761|NCT01908257|"~     This is a drug-drug interaction study in healthy volunteers to evaluate the potential~     pharmacokinetic (PK) effects of ranitidine on lesinurad.~   "
126762|NCT01908244|"~     The purpose of this study is to determine the effects of pentatonic live music on~     physiological parameters in preterm infants.~   "
126764|NCT01908218|"~     Anticipated difficulties at laryngoscopy give time to prepare alternative method and proper~     management.~      Several methods to evaluate the anatomical structures has been used during preoperative~     period for airway assessment.~      Evaluation methods are such as the Mallampati classification, mouth opening, thyromental~     distance and sternocostal distance.~      the Upper Lip Bite test, evaluates the possibility of a patient cover the mucosa of the upper~     lip by the lower incisor.~      The aim of this study was to assess the clinical usefulness of the Upper Lip Bite test(ULBT)~     in Korean compared to Modified Mallampati classification(MMT).~   "
126765|NCT01908205|"~     We are studying an investigational drug called intranasal oxytocin (Syntocinon®). Syntocinon®~     has been approved by the U.S. Food and Drug Administration for use in helping women~     breastfeed, but it has not been approved for use in children with ASD. However, there is~     previous research conducted that has indicated that after administration of oxytocin, adults~     with ASD demonstrated improvements in social cognition, and reduced repetitive behaviours and~     anxiety. There is also early research to suggest that children may also benefit in these~     areas. The purpose of this study is to test if oxytocin works to help children and~     adolescents with ASD.~   "
126766|NCT01908192|"~     The purpose of this study is to determine if NaBen® is a safe and effective add-on treatment~     for schizophrenia in adolescents.~   "
126767|NCT01908179|"~     This registry study will evaluate patients with metastatic brain tumors undergoing, or having~     undergone, stereotactic radiosurgery (SRS) at Swedish Medical Center. Clinical outcomes will~     be evaluated at the 3, 6 and 12-month time points. Clinical data, SRS treatment data, and~     imaging data (including anatomic and advanced imaging sequences obtained prior to and~     serially following SRS) will be archived in an online informatics platform, specifically a~     metastatic brain tumor registry known as the Comprehensive Neuro-oncology Data Repository for~     Metastatic Tumors (CONDR - Mets).~   "
126768|NCT01908166|"~     This clinical trial studies ultrasound elastography in diagnosing patients with kidney or~     liver solid focal lesions. New diagnostic procedures, such as ultrasound elastography, may be~     a less invasive way to check for kidney or liver solid focal lesions.~   "
126769|NCT01908153|"~     The study aims to provide a better understanding of the neural influence of eating behavior~     in the development of childhood obesity. Children ages 4-8 will be recruited to examine fMRI~     brain response to pictures that signal delivery of a chocolate milkshake and to the taste~     itself. The brain response will be compared to body mass index percentile scores for each~     child to help us determine whether brain differences present in adolescents and adults with~     obesity are present in young children.~   "
126770|NCT01908140|"~     The purpose of the study is to compare the efficacy, safety and tolerability of aclidinium~     bromide/formoterol fumarate and salmeterol/fluticasone propionate in patients with chronic~     obstructive pulmonary disease (COPD)~   "
126771|NCT01908127|"~     The aim of this study is to evaluate the effect of Filmed modelling in comparison with~     commonly used Tell-Show-Do technique on the anxious and cooperative behaviour of 4-6 years~     old children during dental practice.~   "
126772|NCT01908114|"~     The objective of the projects is to Develop and implement a Package of interventions that~     will comprise of an augmented communication and counseling strategy coupled with private~     sector involvement and a combined Oral Polio Vaccine and Inject able Polio Vaccine approach~     during the Polio campaigns followed by the evaluation of this project for acceptability,~     feasibility and effectiveness of the intervention Package.~   "
126773|NCT01908101|"~     This phase II trial studies how well eribulin mesylate works in treating patients with~     previously treated breast cancer that has spread to other places in the body. Drugs used in~     chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading.~   "
126774|NCT01908088|"~     Epidermolysis Bullosa (EB) is a blistering disease that is caused by defective anchoring~     fibrils and hemidesmosome in basement membrane of the skin layer. EB is inherited either~     autosomal or recessive and has 3 types. Recessive Dystrophic Epidermolysis Bullosa (RDEB) is~     severe with some morbidity such as mitten hand deformity.~      The management of these patients is very difficult because no effective treatment has been~     known yet.~      The EB patients with mitten hand deformity need surgery to have a biologic dressing for areas~     of hand which is without the skin. In this study the investigators assess the safety of~     autologous transplantation of cultured fibroblast on amniotic membrane (AM,as coverage) for~     them.~   "
126775|NCT01908075|"~     To evaluate whether beclomethasone dipropionate / formoterol (BDP/FOR; Fostair® 100/6) is at~     least equivalent in terms of exacerbation prevention to fluticasone dipropionate / salmeterol~     (FP/SAL; Seretide® 125) in matched asthma patients switching to BDP/FOR following treatment~     with FP/SAL in normal clinical practice compared with patients not switched.~   "
126776|NCT01908062|"~     The purpose of this study is to learn how best to treat substance use disorders in an HIV~     clinic setting. Specifically, the purpose of this pilot study is to learn if extended-release~     naltrexone (XR-NTX) would be a feasible and acceptable treatment for HIV-infected individuals~     with opioid or alcohol use disorders.~   "
126786|NCT01907932|"~     In internal medicine, assessment of spleen size on physical examination is an extremely~     important part of the overall evaluation of patients with many illnesses. Examination of the~     spleen is also one of the core competencies that the investigators expect the students and~     residents to learn as part of their training. Unfortunately, the sensitivity and specificity~     of examination of the spleen at the bedside is not very good. The investigators wish to~     determine if medical residents can be taught to use hand carried ultrasound to accurately~     assess spleen size. Doing so would make physical examination of the spleen obsolete and~     transform training objectives for medical trainees.~   "
126787|NCT01907919|"~     The purpose of this study was to compare the conventional and diode 808 nm laser-assisted~     techniques in direct pulp capping in permanent teeth .The present study was based on a series~     of ten clinical studies with pulp exposure caused by carious lesions.The hypothesis of this~     paper was laser supported direct pulp cap-ping has proven effectiveness by its capacity to~     stimulate reparative dentine formation by pulp cells, de-contamination ability of irradiated~     areas, its ability in the fast and better haemostatic, and pain reduction.~   "
126777|NCT01908049|"~     Objectives: MAIN: To evaluate the parameters of microbial translocation after treatment with~     probiotics (Saccharomyces boulardii) in HIV+ patients and its role on immune reconstitution~     and the changes in gut microbiota composition.~      SECONDARY OBJECTIVES: 1) To analyze the progress of immune activity markers after the~     administration of probiotics. 2) To determine the improvement of CD4+ lymphocytes and HIV~     viral load in patients after taking probiotics.~      Methods: Design: A prospective randomized open controlled double-blinded trial, to be~     performed at a tertiary care hospital in Barcelona. Subjects: Chronic HIV infected patients.~     Sample size: 44 cases. They´ll be divided in 2 groups: (1) Patients with CD4 +> 400 cells /~     ml and undetectable viral load for more than two years (22 cases) and (2) Patients with~     immunodiscordancy, defined as patients with CD4 + T cells lower than 350 cells / ml despite~     4-7 years of effective antiretroviral therapy. (22 cases). Intervention: Patients were~     randomized in 2 subgroups: (A) they´ll receive daily oral supplementation with S. boulardii~     for 3 months and (B) they ´ll receive placebo. Variables: bacterial lipopolisaccharide levels~     measured by the Lipid-Binding protein (LBP), parameters of immune activation in plasma~     (soluble CD14, IFN-Υ, TNF-Alpha, IL (interleukine)-2, IL-5, IL-6, IL-12)and gut microbiota~     composition prior to the use of probiotics (baseline), at 3 and 6 months. Immunological and~     clinical data. Outcome measures: quantification of bacterial translocation levels, markers of~     activity and immune recovery. Analysis: Comparison of variables before and after the~     intervention. The analysis will be performed by biological and immunological effectiveness.~   "
126778|NCT01908036|"~     The use of an activity monitor to determine increase or decrease of activity in patients~     suffering from chronic fatigue syndrome.~   "
126779|NCT01908023|"~     Every year, almost 3000 Norwegian women are diagnosed with breast cancer. Various symptoms of~     short-and long-term side effects may be experienced, such as physical deterioration, reduced~     quality of life and fatigue. At St.Olavs Hospital, Trondheim University Hospital, all~     out-patients undergoing post operative radiotherapy are currently offered participation in~     group exercise training sessions. The main purpose of this study is to evaluate these~     out-patient group exercise sessions.~   "
126780|NCT01908010|"~     This study will investigate safety, tolerability and pharmacokinetics of ABT-354 in up to 20~     male and female subjects, between 55 to 90 years of age with mild to moderate Alzheimer's~     disease on stable doses of acetylcholinesterase inhibitors.~   "
126781|NCT01907997|"~     Systemic lidocaine infusion may improve the patients' recovery quality and chronic post~     surgical pain after robot-assisted thyroidectomy~   "
126782|NCT01907984|"~     Purpose:~      According to the proposal of the International Headache Society acute postcraniotomy headache~     (PCH) is defined as a headache of variable intensity, being most serious at the site of~     surgical intervention and developing within 7 days after craniotomy. Typically, pain resolves~     within 3 months after surgery. According to the literature the incidence of acute PCH during~     the postoperative period is 60% among patients undergoing elective craniotomies. No~     standardized international guidelines are available on the treatment of PCH to the present~     day. Treatment methods can be different based on the country and institution where they are~     used, or even physicians individually can have distinct medication regime, which sometimes~     happens to be habitual and lacks clinical evidences.~      The Department of Anesthesiology and Intensive Care Medicine at the University of Debrecen~     has been giving 100 mg diclofenac with analgesic purpose, as part of the premedication to~     neurosurgical patients for several years. It was observed that the postoperative headache~     following craniotomy was milder comparing to data published in the international literature.~     A pilot study was carried out with similar settings which found the that incidence of PCH was~     lower and less analgesics were required without any further unwanted side-effects among~     patients who received 100 mg diclofenac as part of the premedication.~      Hypothesis:~      100 mg preoperatively given diclofenac significantly reduces the incidence and severity of~     postcraniotomy headache.~   "
126783|NCT01907971|"~     Ebstein anomaly is a rare congenital heart disease. It encompasses abnormalities of the~     tricuspid valve, the right atrium and the right ventricle (RV).~      Currently, cardiac magnetic resonance imaging (MRI) is considered the method of choice for~     the assessment of RV volume and function. To evaluate the right heart function VentriPoint~     method was designed to assess the RV in a fraction of the time, resulting in better efficacy~     and lower costs. VentriPoint is approved for Tetralogy of Fallot patients as well as patients~     with systemic RV in d-transposition of the great arteries. This method uses 2 dimensional~     standard ultrasound views linked to a VentriPoint Medical Systems unit. After acquisition,~     the physician identifies anatomical landmarks with dots on a number of the 2D ultrasound~     views through the heart. With a sensor (magnetic tracking system: GPS) on the ultrasound~     probe we know where the 2D plane is in 3D space. In this way the precise anatomical landmark~     is located in 3D space.~      The aim of the present study is to assess the feasibility, reliability and accuracy of the~     echocardiographic knowledge-based 3D reconstruction method to measure RV volume and function~     in patients with Ebstein anomaly. The accuracy of the method will be assessed by comparison~     with measurements obtained by cardiac MRI.~      In addition to the right ventricle the investigators want to assess the left ventricular~     function in patients with Ebstein anomaly in this study. By using speckle tracking~     echocardiography the investigators would like to investigate on the left ventricular~     contractility, rotation and synchrony of the left ventricle together with the RV. Not seldom~     the left ventricle is neglected in a patient with Ebstein anomaly by impressive findings of~     the right ventricle. Changes in the myocardial left ventricular structure (non compaction)~     are also described and may have negative impact on the function.~      The investigators want to analyze 25-30 patients with Ebstein anomaly including children~     starting at 11 years of age.~   "
126784|NCT01907958|"~     Multicenter stepped wedge cluster randomized trial of family practice clinics in Quebec and~     Ontario comparing the effect of introducing a Point of Care testing (POCT) for urine albumin~     to usual practice on quality of care in hypertensive patients with Type 2 diabetes.~   "
126785|NCT01907945|"~     This study is a non-randomized double cohort study evaluating the impact of social~     network-based water treatment education on sustained household water treatment behaviors over~     12 months of follow up. A three-session curriculum was developed on the spread of water borne~     illness, water treatment methods, and the role of social support in water treatment.~     Participants in the intervention arm will receive this curriculum in a group setting, where~     group members are self-selected members of the study participants' social networks.~     Participants in the comparison arm will receive the same curriculum taught at the individual~     household level. All participants will receive CeraMaji ceramic filters for use in household~     water treatment after participating in the three sessions. Research staff will conduct~     surveys and water quality testing over a period of 12 months to determine whether~     participants continue to use the ceramic filters. Investigators hypothesize that social~     network-based training on household water treatment will result in a higher proportion of~     households using ceramic filters at 6- and 12-months as compared to households receiving~     individual training.~   "
126789|NCT01907893|"~     The study uses a multi-site, cluster design to determine the effectiveness of an intervention~     based on a Trauma Collaborative Care (TCC) model in improving patient outcomes for persons~     with severe orthopedic trauma and enhancing both patient and provider satisfaction with~     overall care. The study will also determine the cost and cost-effectiveness of the~     intervention.~      Primary Hypothesis: Compared to standard treatment alone, access to the TCC Program plus~     standard treatment will result in lower rates of the composite outcome (i.e. positive for~     poor function, depression, and/or PTSD).~      Secondary Hypotheses: Compared to standard treatment alone, access to the TCC Program plus~     standard treatment will result in lower levels of pain and higher rates of return to usual~     major activity and higher levels of health related quality of life. In addition, both primary~     and secondary outcomes will correlate strongly with the intermediate outcome of~     self-efficacy.~   "
126790|NCT01907880|"~     Metastatic breast cancer patients with bone involvement who are at high-risk of subsequent~     skeletal related event (SRE), defined as radiotherapy or surgery to the bone, pathological~     fracture, spinal cord compression, or hypercalcemia (as reflected through: elevated sCTX or~     bone pain or a prior SRE despite receiving standard bisphosphonate therapy) should experience~     a decrease in the surrogate marker, sCTX, at week 12 if switched to zoledronic acid compared~     with those patients who continue on intravenous pamidronate (i.e. current standard of care).~     The investigators propose that a drop in sCTX will correlate with improved pain, quality of~     life and a reduced incidence of further SREs.~   "
126791|NCT01907867|"~     This study investigates the safety, tolerability, and PK profile of finafloxacin as a novel~     fluoroquinolone and a potential therapeutic agent for lower respiratory infections such as~     bacterial pneumonia. A comparison of the PK profile of finafloxacin in plasma and lung ELF~     using different bronchoscopic ELF sampling techniques (BMS and BAL) is conducted.~   "
126792|NCT01907854|"~     This trial is conducted in Asia, Europe and North America. The aim of the trial is to~     investigate the efficacy and safety of switching from sitagliptin to liraglutide in subjects~     with type 2 diabetes not achieving adequate glycaemic control on sitagliptin and metformin.~   "
126793|NCT01907841|"~     Strenuous exercise or exercise involving eccentric muscle contractions can lead to muscle~     damage and changes in muscle function; this is known as exercise-induced muscle damage~     (EIMD). It is known that brief, repeated periods of ischemia followed by reperfusion, known~     as Ischemic Preconditioning (IPC) cause a delay in cell injury in cardiac muscle as well as~     in various other organs.~      Therefore the purpose of this study is to:~        1. Quantify the use of IPC in recovery following EIMD.~        2. Identify any effect of IPC during recovery on muscle function~   "
126794|NCT01907828|"~     The purpose of this post market clinical investigation is to complete preliminary evaluation~     on whether or not concomitant renal denervation with the EnligHTN™ Renal Denervation System~     and cardiac ablation will result in improved outcomes as compared to ablation alone in~     patients with uncontrolled hypertension being treated for Atrial Fibrillation~   "
126795|NCT01907815|"~     This phase II trial studies how well trametinib and protein kinase B (Akt) inhibitor~     GSK2141795 work in treating patients with acute myeloid leukemia. Trametinib and Akt~     inhibitor GSK2141795 may stop the growth of cancer cells by blocking some of the enzymes~     needed for cell growth.~   "
126796|NCT01907802|"~     This phase I trial studies the side effects and best dose of dabrafenib in treating patients~     with solid tumors and kidney or liver dysfunction. Dabrafenib may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth.~   "
126797|NCT01907789|"~     The goal of this clinical research study is to compare ovarian cancer screening,~     risk-reducing salpingo-oophorectomy (RRSO), and prophylactic salpingectomy with delayed~     oophorectomy (PSDO). The safety of RRSO and PSDO will also be studied.~      Ovarian cancer screening does not involve a surgical procedure. Instead, physical exams,~     blood tests, and ultrasound are used to check for ovarian, fallopian tube, and peritoneal~     cancer.~      The surgical procedures, RRSO and PSDO, are designed to lower your risk of ovarian cancer.~      In RRSO, the fallopian tubes and ovaries are removed at the same time.~      In PSDO, the fallopian tubes are removed and the ovaries remain in place so that the patient~     does not go through menopause. The ovaries are removed at a later date. The main goal of this~     study is to learn how many patients actually have their ovaries removed at a later date.~     Researchers also want to learn whether the removal of fallopian tubes will decrease the risk~     of ovarian cancer.~   "
126798|NCT01907776|"~     This is a single-center, randomized, double-blind, placebo-controlled, sequential group~     study. The primary objective of this study is to assess the tolerability and safety of single~     doses of ME1100 inhalation solution (orally inhaled arbekacin). The secondary objective is to~     determine the systemic exposure to, and urinary elimination of, ME1100.~   "
126799|NCT01907763|"~     The objective of this study is to assess the efficacy and safety of SOTB07 in asthma patients~     by observing changes FEV1 (% predicted) as the primary efficacy endpoint after oral~     administration of SOTB07 200mg, 400mg, placebo for 12 weeks.~   "
126800|NCT01907750|"~     To evaluate the safety and effectiveness of the use of transcystic biliary drainage tube (not~     transanastomotic) in comparison to the usual transanastomotic biliary drainage tube.~   "
126801|NCT01907737|"~     Cerebrovascular disease is a major cause of disability worldwide. The catastrophic burden of~     stroke is more dramatic in low- and middle- income countries, and the scarcity of~     evidence-based rehabilitation interventions represents a major challenge to global health~     care. Upper limb weakness is frequent after stroke, but there is no universally accepted~     treatment to effectively improve hand function in patients with moderate and severe motor~     impairment. These are the patients in deepest need of rehabilitative interventions. This~     project addresses this important issue, by testing effects of a novel approach. We will~     non-invasively stimulate the brain and peripheral nerves in order to enhance effects of motor~     training aided by an electrical stimulation device in patients with moderate to severe hand~     weakness. Our hypothesis is that brain stimulation, when added to peripheral nerve~     stimulation, will enhance effects of motor training to a greater extent than brain~     stimulation alone, peripheral stimulation alone, or no stimulation.~   "
126802|NCT01907724|"~     The purpose of this study is to evaluate the potential for a PK drug-drug interaction when~     IDX719, simeprevir, TMC647055 and low-dose ritonavir (RTV) are administered in combination.~     Safety and tolerability will also be assessed.~   "
126803|NCT01907711|"~     background: The Chronic Fatigue Syndrome (CFS) presents many disturbances multidimensional~     affect holistically to people who have the disease and current management of fatigue, pain,~     anxiety, depression and sleep disturbances present in this clinical entity is unsatisfactory.~      Hypothesis:~      The hypothesis of this essay is to contrast that acupuncture is more useful than placebo.~      The investigators suggest the use of a clinical study protocol (PEC), randomized,~     placebo-controlled, acupuncture technique, aimed at increasing the patient's sense of~     well-being, relief of pain and stiffness, acupuncture is effective to reduce fatigue,~     anxiety, depression and sleep disorders in patients diagnosed with CFS.~   "
126804|NCT01907698|"~     Vaginal intercourse to promote labour onset is biologically plausible. Oxytocin release~     during female orgasm, cervix mechanical stimulation and the effect of semen's prostaglandins~     are possible involved mechanisms. The investigators propose to evaluate the effect of vaginal~     intercourse on spontaneous labour at term.~   "
126805|NCT01907685|"~     Primary Objective:~      To determine the dose limiting toxicity (DLT), the maximum administered dose (MAD) and the~     maximum tolerated dose (MTD) of AVE8062 and docetaxel in combination administered~     sequentially on D1 & D2 respectively every 3 weeks in patients with advanced solid tumors.~      Secondary Objectives:~        -  To define the overall safety profile of the combination.~        -  To characterize the pharmacokinetic (PK) profile of AVE8062 and docetaxel when~          administered in combination.~        -  To evaluate anti-tumor activity of the combination.~        -  To evaluate potential predictive biomarkers.~      The study includes a tumoral pharmacogenomic sub-study conducted in a subset of sites. The~     objective to analyse a set of biological biomarkers in order to identify a potential~     predictive signature of efficacy for AVE8062 in combination with docetaxel.~   "
126806|NCT01907672|"~     This study aims to test directly by means of a cluster randomized controlled trial, the~     impact of the introduction of RDTs for malaria on dispensing behaviour of chemical sellers,~     the main non-formal outlet for drugs locally, at community level.~   "
126807|NCT01907659|"~     This trial is a pilot study to determine the feasibility of a randomized clinical trial~     comparing a treatment algorithm consisting of a limited number of clinical parameters, rapid~     molecular viral diagnostics, and serum procalcitonin testing to standard of care for~     directing antibiotic use in patients with non-pneumonic lower respiratory tract infection.~     The reduction in antibiotic use in those subjects randomized to the treatment algorithm~     compared to those randomized to standard care will be determined.~   "
126808|NCT01907646|"~     The objective of the study is to evaluate the impact and the outcome of bladder training~     during post-operative hospital stay after radical hysterectomy, mainly after neoadjuvant~     concurrent chemo-radiation therapy for locally advanced cervical cancer.~   "
126809|NCT01907633|"~     The purpose of this observational study is to assess the risk of out-of-hospital Sudden~     Cardiac (heart) Death (SCD) associated with current use of domperidone compared to current~     use of a Proton Pump Inhibitor (PPI), current use of metoclopramide, or non-use of any of~     these medications.~   "
126810|NCT01907620|"~     The aim of this study is to explore a mechanism that could potentially explain why women with~     a pregnancy complicated by pre-eclampsia are described as having an increased risk of~     cardiovascular disease later in life.~      If the hypothesis of this study turns out to be true, that is to say that women with~     pre-eclampsia have a higher level of oxidative stress than women with a normal pregnancy and~     that this difference persists after the delivery (6 months), a controlled randomized~     interventional study aiming to evaluate either therapeutic supplementation with antioxidant~     vitamins (Vit C and E) or modifications in diet could be envisaged.~   "
126811|NCT01907607|"~     The treatment of advanced GIST patients is based on imatinib followed with sunitinib in case~     of resistance/intolerance. However, the median progression-free survival (PFS) on sunitinib~     is frequently short, and after failure with both imatinib and sunitinib, treatment remains~     controversial.~      Previous studies on GISTs have linked 9p21 alterations to tumor progression (El-Rifai et al.~     2000; Kim et al., 2000; Schneider-Stock et al., 2003; Schneider-Stock et al., 2005; Romeo et~     al. 2009; Haller et al., 2008) but the driver gene was not positively identified (CDKN2A,~     CDKN2B, or MTAP) (Astolfi et al., 2010; Belinsky et al., 2009; Perrone et al., 2005; Assamaki~     et al. 2007; Huang et al., 2009). A recent study has shown that homozygous 9p21 deletions~     target CDKN2A and more specifically p16INK4a 4. Most of the CINSARC genes are known to be~     under the transcriptional control of E2F. RB1 sequesters E2F, which is released from the~     complex upon RB1 phosphorylation by CDK4. CDK4 is, in turn, inhibited by p16INK4a. Hence, we~     hypothesize that alteration of the restriction point via deletion of p16INK4a (and more~     rarely of RB1: 20% of cases) gene in GISTs is likely to be a causative event that leads to~     the overexpression of CINSARC genes, which in turn induce chromosome instability and~     ultimately metastasis. Low p16INK4a expression was associated with response to PD-0332991 in~     several in vitro tumor model(Konecny et al. 2011; Katsumi et al. 2011; Finn et al. 2009).~     Considering our molecular data, we believed that PD-0332991 warrants clinical investigation~     in advanced gastrointestinal stromal tumors with alteration of p16INK4a. This alteration is~     detectable by comparative genomic hybridization which is a technique highly manageable in the~     context of routine clinical care and clinical trial.~      Exploratory, one-arm, multicenter, phase II clinical trial based on twostage Simon's design~      To assess the antitumor activity of PD-0332991 in terms of non-progression at 16 weeks (after~     centralized review) in patients with documented disease progression while on therapy with~     imatinib and sunitinib for unresectable and/or metastatic GIST.~      This is a multicentre single-arm Phase II study evaluating the efficacy and safety of orally~     PD-0332991, 125 mg/day, 21 days on/7 days off, in patients with documented disease~     progression while on therapy with 2nd line sunitinib for unresectable and/or metastatic GIST.~     Indeed, the usual treatment for advanced Gastrointestinal Stromal Tumors Refractory to~     Imatinib and Sunitinib is best supportive care for which outcome data are already available~     (Demetri et al., 2012; Italiano et al., 2012). Sixty three patients will be included in 10~     centres of the French Sarcoma Group over a period of 18 months of enrolment.~      Patients will be evaluated at scheduled visits in up to three study periods:~        -  Pre-treatment (PRE TT): from signature of informed consent to the first treatment by~          PD-0332991.~        -  Treatment (TT): from the first treatment by PD-0332991 to the first 28 days following~          the last PD-0332991 administration.~        -  Follow-up (FUP): after treatment discontinuation, all patients must be followed up for~          28 days after the last dose of the study drug for safety assessment (AEs and/or SAEs).~   "
126812|NCT01907594|"~     The investigators previously developed a cigarette cue extinction treatment (CET) procedure~     in non-treatment seeking volunteer smokers in our nicotine laboratory. The goal of Cue~     Extinction Treatment is to un-pair a behavioral or autonomic response from the stimulus that~     triggers it. This is accomplished through repeated exposure to that trigger, while removing~     the patient's ability to act out the conditioned response. In the present study, the trigger~     is a lit cigarette, and the response the investigators seek to un-pair is cigarette craving.~     In the procedure the investigators have previously developed and intend to use again, the~     participant is shown a pack of his brand of choice cigarettes. The researcher removes a~     cigarette from the pack, lights it, and asks the participant to hold the cigarette without~     smoking it for 90 seconds. This procedure is repeated seven times over the course of a~     six-hour lab session. The investigators hope to boost the clinical response to smoking cue~     exposure therapy in quitters on NRT (nicotine replacement therapy) pretreatment by~     pharmacological augmentation with the partial NMDA receptor agonist D-cycloserine (DCS).~     Behavioral extinction training is a form of learning that may be modulated by NMDA receptor~     mediated glutamate transmission. The study's main hypothesis is that the partial NMDA~     receptor agonist D-cycloserine (DCS) facilitates cue exposure training and may prevent~     relapse to smoking. The aim of the proposed study is to assess whether DCS-facilitation of~     cue-exposure therapy improves abstinence among smokers on the nicotine patch seeking~     treatment. Development of an effective treatment strategy to enhance the effectiveness of~     NRTs would have a direct and significant positive impact on public health.~   "
126813|NCT01907581|"~     A gravity admission largest resuscitation and a poorer prognosis are expected for patients~     experiencing socio-economic vulnerability. This is the first study in France and~     investigating the field of resuscitation which will allow us to have a vision of the French~     health system and its consequences. The frequency of PTSD is expected to be more important in~     this vulnerable population itself with quality of life at discharge worse. The results of~     this study are a prerequisite for the implementation of preventive measures targeted and more~     suitable for those patients experiencing socio-economic vulnerability remediation.~   "
126814|NCT01907568|"~     Psychotic symptoms (hallucinations and delusions) are present in several psychiatric and~     neurological disorders as well as in the general population. Effective treatment strategies~     for these symptoms in all patients are lacking and treatment-response can presently not be~     predicted. To date, the exact pathophysiological mechanism of these symptoms remains unknown.~     By investigating (subtypes) of hallucinations and delusions in all populations, a common~     pathway may be found, leading to more effective treatment options. Alternatively, different~     subtypes may be associated with different pathophysiological mechanisms.~   "
126816|NCT01907542|"~     Background Stapled skin closure is frequently performed following open colectomies. However,~     its pain and cosmetic outcomes have been suboptimal. Monocryl sutured skin closure has been~     shown to be cosmetically superior and does not require removal of the sutures. But its~     association with wound infection has been questioned Aims This study aims to compare the~     outcomes using skin stapler or Monocryl suture in the skin closure following open colectomy.~     Hypotheses We believe Monocryl suture is associated with reduced pain and better cosmesis.~     Methodology Inclusion criteria: All patients who underwent elective open colectomy for~     various etiologies Exclusion criteria: i) Emergency laparotomies ii) Patient who require the~     creation of a stoma After consenting for the trial, patients will be randomized into either~     the skin stapler or the Monocryl suture group. Randomization is performed using a computer~     model. To minimize confounders, the pre-operative preparation and antibiotics regime will be~     standardized. The closure of the fascia and the skin will also be performed by at least a~     Registrar. The wounds will then be covered with a thick sterile dressing to blind the patient~     and the research assistant. The wound will only be reviewed on the POD 3. The patient is~     scheduled to return on POD 14, POD 30, 3 and 6 months post operatively upon discharge. Some~     of the variables that will be collected for this study include: 1. Time taken for skin~     closure 2. Superficial surgical site infection 3. Pain score 4. Cosmesis We aim to enrol 72~     participants in each group. Importance/Impact to Medicine This study will validate the role~     of Monocryl suture as an effective method for skin closure following open colectomy. We~     believe Monocryl sutured closure can potentially change the practice of surgeons worldwide~     for the benefits of the patients.~   "
126817|NCT01907529|"~     The trial was designed to study the efficacy and safety of neoadjuvant docetaxel, epirubicin~     in combination with cyclophosphamide(DEC) plus human recombinant endostatin (endostar) for~     breast cancer patients. The hypothesis of this protocol is that the combined an active~     angiogenesis agent to chemotherapy could enhance the pathological responce rate and further~     benefit breast cancer patients.~   "
126818|NCT01907516|"~     To compare compliance and satisfaction between a traditional method of blood glucose~     reporting using voicemail (control) and a novel method using cell phone /internet (Confidant)~     technology in the management of diabetic pregnant women.~   "
126819|NCT01907503|"~     To assess the prognostic value of a characteristic evaluation of gait in persons suffering~     from hip OA for subsequent indications for THR.~   "
126820|NCT01907490|"~     The purpose of the study is to evaluate the safety and tolerability of a single application~     of Ha44 Gel 0.74% w/v for the treatment of head lice under maximal use conditions.~      Secondary objective is to evaluate pharmacokinetics of Ha44 and benzyl alcohol (contained in~     Ha44 vehicle) under maximal use conditions.~   "
126821|NCT01907477|"~     The aim of the present work is to study the protein expressions profiles of neutropenic~     patients (with a high risk of invasive mycosis) who developed - versus who did not develop~     invasive mycosis (principally aspergillosis and candidosis) in order to identify biomarkers~     for the diagnosis, prognosis and /or prediction of invasive mycosis.~   "
126822|NCT01907464|"~     Nutritional deprivation of adolescent girls with anorexia nervosa (AN) reduces the bone mass~     acquisition. A better understanding of this process would improve the medical treatment of~     bone alteration and its long-term consequences.~      160 patients (age < 38 yr) with AN and 160 age-matched controls (CON) will be enrolled in~     this study. The areal bone mineral density (aBMD) will be determined using dual-X-ray~     absorptiometry. Calciotropic hormones, bone turnover markers will be concomitantly evaluated.~   "
126823|NCT01907451|"~     This project aims to study the effects early individualised retraining programme on walking~     ability in patients following hemiplegic stroke.~   "
126824|NCT01907438|"~     Susceptibility to breast cancer is related to the combination of genetic, hormonal and~     multiple other environmental risk factors, such as mutations in the BRCA gene and excess~     exposure to exogenous estrogen, respectively. BRCA is a nuclear protein that maintains genome~     stability, by acting as a key player in the DNA repair complex. Recently, evidence has~     emerged that BRCA mutation heterozygosis itself enhances aborted DNA repair and can~     contribute to breast cancer initiation after exposure to irradiation. In our preliminary~     results on short-term lymphocyte cultures, we found additional evidence that healthy~     heterozygous BRCA1 and BRCA2 mutation carriers have a different response to DNA damage than~     do non-carriers.~      The main aim of our ongoing project is to identify the transcriptional modulation and~     transformation potential of normal BRCA1 and BRCA2 mutation heterozygous epithelial breast~     cells following irradiation and to examine how it is affected by exposure to estrogen. Our~     hypotheses will be investigated by RNA-seq and microRNA-seq in order to identify a unique~     molecular expression profile of the estrogen exposed cells following ionizing irradiation.~      Understanding the role of BRCA heterozygosity in cell response to exposure to estrogen and to~     irradiation may facilitate the development of more appropriate diagnostic and therapeutic~     strategies for these individuals.~   "
126825|NCT01907425|"~     In the prenatal period, les supernumerary marker chromosomes (SMC) and de novo apparently~     balanced reciprocal translocations are revealed by foetal karyotyping, which does not always~     make it possible to determine whether the anomaly is balanced or not and does not reveal~     uniparental disomy. The presence of these chromosomal rearrangements raises a difficult~     question for genetic counselling during pregnancy because of the risk of intellectual~     deficiency in the foetus. CGH+SNP-Array can provide information concerning 1) the balanced or~     not nature of these translocations 2) the presence or not of euchromatin in the SMC 3) the~     presence or not of uniparental disomy.~   "
126826|NCT01907412|"~     This is a research study to evaluate the effectiveness of the Family Foundations program and~     to better understand how families cope with having a new baby. The research questions~     include: What is the effectiveness of the Family Foundations program? How do families cope~     with having a new baby?~   "
126845|NCT01907165|"~     This clinical trial studies disulfiram in treating patients with glioblastoma multiforme~     (GBM) who have completed radiation therapy with temozolomide. Disulfiram may block some of~     the enzymes needed for tumor cell growth and improve clinical outcome in GBM patients.~   "
126846|NCT01907152|"~     The objective of this study is to investigate the acceptance, intake, and compliance of~     protein enriched bread and protein enriched yoghurt drinks in elderly patients in two real~     life settings (short term; hospital, and longer term; rehabilitation home).~   "
126827|NCT01907399|"~     There is a link between activation of the immune response inducing chronic inflammation and~     both obesity and type 2 diabetes. To date, however, the cause(s) of this inflammation, the~     mechanisms of the inflammatory cascade and the type of cells involved are not completely~     known. The aim of our project is to study the principal cell types involved in the immune~     response from a quantitative and functional point of view in obese diabetic patients versus~     obese non-diabetic patients and healthy subjects who are neither diabetic nor obese.~      Despite possible inter-individual heterogeneity of immune cells, the fact that this work will~     be carried out by an accredited team with considerable expertise in the study of almost all~     the different types of immune cells will probably make it possible to know whether cell~     dysfunction and inflammation are associated with obesity or rather linked to insulin~     resistance. This study will be completed later by a second study on cell infiltration in~     adipose tissues in the 3 groups defined above. Better understanding of the physiopathology~     and especially the mechanisms and type of cells involved in obesity-related inflammation~     could quickly lead to the development of appropriate therapies that could act specifically on~     the cells involved and thus preclude the onset of complications.~   "
126828|NCT01907386|"~     Abdominal aortic aneurysm (AAA) is an abnormal dilatation of the aorta in the abdomen~     secondary to hypertension and atherosclerosis. Surgical treatment of AAA is increasingly~     being replaced by endovascular aneurysm repair (EVAR) using stent-grafts (SGs). However, the~     efficacy of this less invasive approach is often jeopardized by the incidence of persistent~     flow within the aneurysm, called endoleaks leading to aneurysm rupture if not properly~     detected and treated. Hence, a life long annual CT-scan surveillance is required increasing~     the cost of EVAR, exposing the patient to ionizing radiation and nephrotoxic contrast agent.~     The goal of this project is to adapt and test a new ultrasound technology called ultrasound~     elastography to improve patient follow-up after EVAR and ultimately avoid the use of~     CT-scans. This technique measures the deformation of the tissue secondary to blood pressure~     variation (quasi-static elastography) or to a shear wave generated by the ultrasound probe~     (dynamic elastography). The investigators will optimize 2 approaches to generate elastic maps~     of the AAA. One approach will be a quasi-static elastography (QSE-LSME) technique developed~     by our team giving an estimation of the deformation (strain) of the different components of~     the AAA by the blood pressure. The second is a dynamic elastography (SSWI) technique that~     will provide information on the elastic property of the AAA components.~   "
126829|NCT01907373|"~     Hypertension and hyperuricaemia are widespread conditions. There is significant overlap~     between the two conditions. Serum uric acid (SUA) is currently recognized as a risk factor~     for cardiovascular disease. Thus, at some point in their therapy, hypertensive patients with~     hyperuricaemia are likely to require concurrent treatment with anti-hypertensive and~     hypouricaemic agents. For this reason, it is important to determine whether there are any~     pharmacokinetic interactions resulting from the concomitant administration of such~     agents.Olmesartan is an angiotensin II receptor antagonist and effective and well tolerated~     in the treatment of arterial hypertension. Probenecid is a well-established hypouricaemic~     agent for the treatment of hyperuricaemia and gout.The goal of this study was to examine the~     impact of coadministration of probenecid on the pharmacokinetic parameters and tolerability~     of olmesartan in healthy volunteers.~   "
126830|NCT01907360|"~     This study will be conducted in 2 separate stages, the first in adolescents and the second in~     children. Both Stages 1 and 2 will use an adaptive, single or multiple cohort open-label,~     single-treatment, fasting design examining the pharmacokinetic (PK) effects of up to 2~     separate modified release (MR) formulations (B and C) of HLD200 (54 mg).~   "
126831|NCT01907347|"~     Critically ill patients feature a loss of fat-free mass (FFM) up to 440 g/day, which is~     associated with increased morbidity and prolonged recovery. In several clinical conditions,~     FFM or phase angle (PhA)derived from BIA have been associated with clinical outcome. However,~     solid data to support this association in ICU patients are lacking. Only one retrospective~     study of 51 ICU patients with acute respiratory failure correlated loss of active cell mass~     with mortality. In a pilot study performed in 55 ICU patients, the investigators observed~     that five kHz BIA PhA was significantly related to SOFA (r=0.38, P=0.03). The relation~     between PhA and mortality remains to be determined in ICU patients.~      Classic ICU validated severity scores (e.g. Acute Physiology and Chronic Health Evaluation~     (APACHE), Sequential Organ Failure Assessment (SOFA), Simplified Acute Physiology Score~     (SAPS)) and recent nutritional scores have been developed to foresee the clinical outcome of~     ICU patients. Most of these scores are time consuming and suffer some degree of~     discriminative power (i.e. APACHE II and SAPS II are not validated in cardiovascular surgery~     patients).~      PhA is reflecting intracellular status: altered intracellular water (ICW) to extracellular~     water (ECW) distribution is suggested by low PhA. PhA measurement does not require anamnestic~     parameters, body weight, and lab tests. It could easily, accurately and repeatedly measured~     at bedside. PhA has been correlated with the disease prognosis in HIV infection,~     hemodialysis, peritoneal dialysis, chronic renal failure and liver cirrhosis patients. These~     studies suggest that PhA may be useful in determining increased risk of morbidity in the ICU.~      Computerized tomography (CT) images targeted on the 3rd lumbar vertebrae (L3) could~     accurately measure FFM13 and predict survival in cancer patients. Body composition evaluation~     by CT presents great practical significance due to its routine ICU use in the initial~     diagnosis or follow-up. The usefulness of measuring FFM with L3-targeted CT has never been~     evaluated in ICU patients.~      Therefore, the investigators aim to conduct an international multicentre prospective~     observational study in ICU patients to assess the prognosis value of BIA PhA at admission,~     and to compare the performances of BIA and L3-targeted CT for FFM measurement.~   "
126832|NCT01907334|"~     To examine whether a breathing test (methacholine challenge using impulse oscillometry) can~     be used to tell the difference between two different doses of an inhaled drug, salmeterol,~     delivered by Advair in children with asthma~   "
126847|NCT01907139|"~     There are 3 specific study purposes. First, we will examine the treatment effects of RT~     combined with dCIT (RT + dCIT) compared to RT, dCIT, and a dose-matched control therapy~     (DMCT) in stroke patients. Outcome domains will include motor, sensory, and muscle functions,~     amount of arm activity in real-life situations, patient-reported outcomes of daily~     performance and quality of life, and kinematic performance. Additionally, potential adverse~     effects including fatigue, pain, and a biomarker of oxidative stress will be examined.~     Second, we will investigate if the demographical and clinical characteristics of stroke~     patients may predict the probability of achieving clinically important changes of treatment~     outcomes. Thirdly, this study will examine whether the improvements after treatment reach~     clinically important or not and assess clinimetric properties of the outcome measures.~   "
126870|NCT01906840|"~     Despite advances in prevention of cardiovascular diseases, the incidence of accelerated~     atherosclerosis in hemodialysis (HD) patients has still remained high. Oxidative stress is~     considered as a major player in uremia associated morbidity and mortality in HD patients. The~     aim of this study was to evaluate the effects of turmeric on oxidative stress markers in HD~     patients.~   "
126833|NCT01907321|"~     Stroke is the leading case of neurologic swallow dysfunction, or dysphagia. Post stroke~     dysphagia is associated with approximately 50% increase in the rate of pneumonia diagnoses;~     aspiration pneumonia is the most common respiratory complication in all stroke deaths,~     accounting for a three-fold increase in the 30-day post stroke death rate. The long-term goal~     of this systematic line of research is to decrease the morbidity, mortality, and health care~     costs associated with disordered airway protection following stroke.~      The overall hypothesis central to this proposal is that the ability to protect the airway is~     dependent upon a continuum of multiple behaviors, including swallowing and cough. Safe,~     efficient swallowing prevents material from entering the larynx and lower airway, and~     effective cough ejects aspirate or mucus material. Currently, only one end of the continuum,~     swallowing, is rigorously assessed in stroke patients. However, ineffective or disordered~     cough is indicative of the inability to eject aspirate material or clear mucus and secretions~     from the lower airway. Ineffective clearance and subsequent accumulation of material in the~     lower airway increases the risk of chest infection. Hence, patients at the greatest risk for~     chest infection would not only have disordered swallowing (dysphagia) but also disordered~     cough (dystussia), meaning they are more likely to aspirate material and then cannot~     effectively eject the aspirate from the airway. There is a high likelihood that swallowing~     and cough are simultaneously disordered following stroke. To date, there is a treatment that~     targets both swallowing and cough function in stroke patients.~      Expiratory muscle strength training (EMST) increases expiratory muscle strength (Baker et~     al., 2005) and there is evidence that supports its use to improve both swallow and cough~     functions in patients with Parkinson's disease (Troche et al., in press). This cross-system,~     device-driven approach to rehabilitating multiple contributors to airway protection deficits~     is highly desirable in the stroke population due to the likelihood of the co-occurrence of~     both swallow and cough disorders. To date, EMST has not been tested in stroke patients. We~     propose that by including cough in the screening, evaluation and treatment processes for~     disorders of airway protection, we will be able to better identify and treat patients most at~     risk for airway compromise and associated sequelae.~   "
126834|NCT01907308|"~     This study plans to learn more about the combination of AMG 386 and docetaxel for the~     treatment of advanced urothelial cancer. Subjects are being asked to be in this research~     study because they have advanced urothelial cancer which has progressed after treatment with~     a platinum-based therapy.~      The hypothesis is that AMG 386 will increase the historical response rate of docetaxel as a~     single agent.~   "
126835|NCT01907295|"~     Pulmonary arterial hypertension (PAH), or high blood pressure in the lungs, is a rare~     condition that can shorten life. Although the cause of this disease is usually unknown, in~     about 70% of heritable and 15-20% of idiopathic cases there is a change in a gene (a~     mutation) that controls how blood vessels grow and function. The gene is called bone~     morphogenetic protein type receptor 2 (BMPR2). Although mutations in BMPR2 are a risk factor~     for PAH, not everyone with a mutation gets the disease. Additional genetic and environmental~     factors are likely to contribute. The investigators suspect that mutations in other genes are~     responsible for some cases of PAH. In this study the investigators aim to recruit all~     patients with PAH and some of their relatives and follow them up for several years. The~     investigators hope to discover new mutations for this disease and to determine what factors~     lead to poor outcome, and to understand what triggers disease in patients with mutations.~      Who can participate? Adults with PAH, their relatives and controls (one off blood sample)~   "
126836|NCT01907282|"~     Preventing psychotic disorders such as schizophrenia and associated functional disability~     could relieve an enormous burden of personal and family suffering and economic losses to~     society. This project aims to conduct a pilot randomized trial to determine the efficacy of a~     family-focused treatment in comparison with treatment-as-usual in enhancing functional~     outcomes, stabilizing symptoms, and preventing or delaying the onset of full psychosis in~     transitional age youth with prodromal symptoms. The results of this study will be crucial for~     the development of cost-effective, evidence-based psychosocial approaches to psychosis~     prevention and thus will have major implications for public health.~   "
126837|NCT01907269|"~     The purpose of this study is to conduct a randomized trial of a tailored intervention~     designed to provide personalized feedback regarding patients' risk of subsequent fractures,~     customized information regarding osteoporosis care, and messaging to activate patients to~     become more engaged in improving osteoporosis treatment and doctor-patient communication.~     This novel content will use story-telling delivered via the Internet and digital video~     discs (DVDs). The content will be uniquely tailored to each person based on barriers to care,~     age and race/ethnicity. We will conduct a controlled, cluster-randomized trial of this~     intervention to determine differences in post-intervention rates of osteoporosis care between~     two randomization arms.~      We hypothesize that participants randomized to the intervention arm, compared to those~     randomized to a control arm, will receive more osteoporosis care at 6 months~     post-intervention, as evidenced by higher rates of: (H1) Prescription osteoporosis therapies,~     (H2) Non-prescription therapy with calcium and vitamin D, and (H3) Bone mineral density (BMD)~     testing.~   "
126838|NCT01907256|"~     There was not any randomize trial to show what is the best type of incision in open~     rhinoplasty. So, we use both self-rating by patients ,independent physician observers Visual~     Analogue Scale (VAS) and also a validated scar analysis to compare inverted V and stair step~     incisions.~   "
126839|NCT01907243|"~     Nasal obstruction is a preventable complication of rhinoplasty, for which the spreader graft~     is the gold standard. More recently, the spreader flap technique has been espoused as an~     alternative to spreader grafting. Herein we evaluated the efficacy of this technique in a~     randomized trial setting.~   "
126840|NCT01907230|"~     Antiviral prophylaxis can prevent the risk of biologic agents-associated HBV reactivation in~     hepatitis B inactive carriers and patients with past HBV infection~   "
126841|NCT01907217|"~     Electroconvulsive therapy (ECT) is the most powerful antidepressant treatment available and~     is often life-saving. There are concerns, however, that standard bitemporal ECT (the most~     commonly used form of ECT worldwide) causes persisting retrograde amnesia. However, clinical~     trials have indicated that high-dose unilateral ECT may be as effective as bitemporal ECT but~     have much less cognitive side-effects.~      The trial aims to test the primary experimental hypothesis: High-dose (6 x ST) right~     unilateral ECT is as effective as (i.e. not inferior to) standard (1.5 x ST) bitemporal ECT~     for severe depression in terms of Hamilton Depression Rating Score (HDRS) at the end of the~     treatment course.~   "
126842|NCT01907204|"~     The purpose of this study is to determine whether inhaled corticosteroid (specially~     nebulized) could be a good alternative to oral corticosteroid and whether they are effective~     in the treatment of sinusitis~   "
126843|NCT01907191|"~     This study is being undertaken to compare the pain control using either bupivacaine versus~     liposomal bupivacaine. Liposomal bupivacaine can potentially provide pain relief lasting up~     to 72 hours while regular bupivacaine can provide pain relief up to 12 hours~   "
126844|NCT01907178|"~     To investigate postoperative pain management in patients undergoing knee or hip replacement~     while they are in the hospital and following discharge to their home. Additionally, sample~     questions will be asked prior to surgery to predict patient's postoperative pain experience.~   "
126848|NCT01907126|"~     The pilot study aims to conduct a randomized pilot trial in a sample of 40 incarcerated women~     with lifetime interpersonal violence who are 6-10 weeks away from release to demonstrate the~     feasibility and acceptability of the proposed recruitment methods and research design, of the~     intervention training methods, of delivering the enhanced Women's Coop and nutrition control~     interventions. Per recent guidance from NIMH, the investigators will also examine 95%~     confidence intervals around differences between the proposed intervention and a dose-matched~     control condition (Nutrition Program), for the following outcomes through 8 months post~     prison release: reduced unprotected vaginal or anal sex occasions and fewer cases of vaginal~     trichomoniasis (primary); reduced interpersonal violence episodes, symptoms of PTSD and~     depression, and drug using/heavy drinking days (secondary); and increased affect management~     and social support (including effectiveness in obtaining substance use, mental health~     treatment and other resources) (tertiary).~   "
126849|NCT01907113|"~     Assessment of the effect of normal and impaired kidney function on the pharmacokinetics,~     pharmacodynamics and safety of BI 10773~   "
126850|NCT01907100|"~     This is a phase II/III confirmatory study designed to evaluate the safety and efficacy of~     nintedanib (BIBF 1120) in combination + (pemetrexed / cisplatin) followed by nintedanib (BIBF~     1120) versus placebo + pemetrexed / cisplatin followed by placebo for the treatment of~     patients with unresectable malignant pleural mesothelioma.~   "
126851|NCT01907087|"~     The purpose of this study is to determine whether BMN 190 is safe and effective in the~     treatment of patients with Late-Infantile Neuronal Ceroid Lipofuscinosis Type 2 (CLN2)~     disease.~   "
126852|NCT01907074|"~     As the treatments for liver disease and the availability of liver transplantation have~     progressed, the number of patients with end stage liver disease continues to increase. This~     has increased the need to risk-stratify patients with cirrhosis to better direct their~     treatments and provide an accurate prognosis for their outcomes. The traditional assessment~     of the liver patient has been limited to imaging, static measures of liver function tests~     and liver biopsy. This protocol is designed to increase the spectrum of tests in the~     evaluation of the patient with end stage liver disease.~   "
126853|NCT01907061|"~     Trial to test the effect of administering N-acetylcysteine on cytokines and markers of~     oxidant stress and the incidence of acute renal failure post liver tranplant~   "
126854|NCT01907048|"~     This cross-sectional epidemiologic study will measure physician and patient awareness and~     understanding of the key messages in the Xarelto prescriber guide and Xarelto patient alert~     card.~   "
126855|NCT01907035|"~     OBJECTIVE: Evaluate the effectiveness of quality of life score, a cognitive-behavioral~     intervention by psychologists in the field of primary care in anxiety-depressive patients,~     mild to moderate, compared with usual care.~      DESIGN: Clinical trial, multicenter, prospective, and randomized into two parallel groups.~     SCOPE AND SUBJECTS: We included a random sample of 246 patients anxious-depressive, mild /~     moderate, belonging to the target population of 41 doctors from several health centers.~     INTERVENTION: In the 246 patients randomly assigned to the intervention group, with a~     standardized program of cognitive behavioral therapy applied by psychologists, by the usual~     treatment or control group, which will be standard care. MEASUREMENTS: The main result will~     be changes in general health scores of the SF-36. It will also measure the change in~     frequency and intensity of anxiety-depressive symptoms on the scales HARS, HDRS, STAI and BDI~     at baseline and at 2, 6 and 12 months. In addition, also collected for drug use and health~     services.~      ANALYSIS: Analyses were performed by intention to treat, comparing the change obtained in~     both groups at the end of the 12 month follow up. Estimates of the effect attributable to the~     intervention by the difference in those changes, adjusting in addition to the baseline, the~     possible confounding covariates or effect modifiers of the intervention, using longitudinal~     mixed-effects models.~   "
126856|NCT01907022|"~     Repetitive Transcranial Magnetic Stimulation in combination with relaxation therapy is used~     to modulate the neural pathways contributing to the perception and distress of phantom~     sounds.~   "
126857|NCT01907009|"~     The management of (castration-resistant) prostate cancer (CRPC) is becoming increasingly~     complex. The use of peripheral anti-androgens with gonadorelin analogues (maximum androgen~     blockade) is common place. Following the failure of such an approach, several strategies may~     be employed. Both corticosteroids and estrogens have a role and increasingly chemotherapy is~     being used. The demonstration of enhanced survival using 3 weekly docetaxel has meant that~     this is viewed by many as the standard of care for fit patients.~      Melphalan is an established alkylating drug that has demonstrated some activity in CRPC, but~     to date, myelosuppression has prevented adequate dosing. We have recently conducted a phase I~     dose escalation study using melphalan and whole blood stem cell re-infusion and it shows that~     median overall survival is 22 months, which is higher than the median survival rate of 19~     months for Docetaxel~      Data from a previous phase I study has proved the successful administration of higher doses~     of IV Melphalan in combination with autologous blood infusion in patients with~     Castration-resistant prostate cancer.~      Rapid falls in circulating tumour cells were seen within 2 weeks of starting Melphalan,~     however slow platelet recovery meant longer periods of platelet transfusion. For this study~     we intend to assess the efficacy of an intensified intravenous melphalan with autologous~     whole blood stem cell transplantation over three treatment cycles.~      39 patients will be enrolled over a 3 year period and at least 17 patients need to survive~     progression free at least 6-months for this study to be considered positive.~      Mel-CAP is a combination chemotherapy consisting of two chemotherapy drugs:~      MELPHALAN and LENOGRASTIM for 3 cycles alternately.~   "
126858|NCT01906996|"~     There are two types of interventions to treat a post-traumatic wrist osteoarthritis: the~     proximal row carpectomy and the four corner fusion. They are used to reduce pain and to~     maintain the mobility. In previous studies are shown that the proximal row carpectomy shows a~     better mobility of the wrist postoperatively, whereas the four corner fusion has lower~     progression of radiocarpale osteoarthritis.~      The purpose of this study is to compare the clinical, radiological and subjective outcomes~     after the treatment with a proximal row carpectomy or a four corner fusion.~   "
126910|NCT01906307|"~     Hepatorenal syndrome (HRS) is a life-threatening condition marked by rapid decline in kidney~     function in patients with liver cirrhosis or fulminant liver failure. Vasodilation in the~     gastrointestinal region is largely thought to contribute to the disease. LJPC-501 is a~     vasoconstrictor that may restore proper circulation and kidney function in patients with HRS.~   "
126859|NCT01906983|"~     The true incidence of thrombosis in the portal venous system after blunt splenic trauma is~     unknown and has not been elucidated in the medical literature. The investigators hypothesize~     that this entity is more common than previously suspected. Consequences of missing this~     diagnosis can be clinically significant, i.e. mesenteric ischemia in the acute phase and~     portal venous hypertension in the chronic phase. Early diagnosis would facilitate treatment~     with anticoagulation and avoidance of these complications. In a prospective fashion, doppler~     ultrasound will be performed prior to discharge and at 3 months in all patients 18 and up who~     have sustained blunt splenic trauma. Clinical follow-up will be extended to 6 months in~     patients initially diagnosed with thrombosis in the portal venous system on their 3 month~     ultrasound. The investigators will attempt to identify risk factors in this trauma population~     that would facilitate an early screening protocol.~   "
126860|NCT01906970|"~     A single centre, clinical experimental study. Every subject will undergo clamp experiments,~     where a clamp device (ClampArt®) measures and controls the blood glucose concentration after~     administration of marketed insulin products.~   "
126861|NCT01906957|"~     The aim of study is to investigate the impact of two different training modalities (high~     intensity interval training (HIIT) versus moderate intensity continuous exercise training~     (MICET) on cognitive performance, cerebral oxygenation, cardiac output and physical fitness~     in older healthy adults, patients with metabolic syndrome, coronary heart disease and heart~     failure. The investigators hypothesized that HIIT modality will lead to a larger improvement~     in physical fitness (i.e. VO2peak), cardiovascular parameters (cardiac output and stroke~     volume) and cognitive performance at rest and during submaximal exercise. The primary~     endpoint will be the improvement in cognitive performance.~   "
126862|NCT01906944|"~     Patients with chronic abdominal pain- with a component of abdominal wall pain- are often~     treated with trigger point injections. This study will help to determine if a block within~     the transversus abdominis plane (TAP) will provide superior analgesic benefit to a trigger~     point injection as therapy for these patients.~   "
126863|NCT01906931|"~     People with interstitial lung disease (ILD) are frequently prescribed ambulatory oxygen, to~     increase oxygen levels in the blood during daily activities. The best way of delivering this~     type of oxygen has not been established. The aim of this study is to compare two devices for~     delivering oxygen in people with interstitial lung disease - the traditional method using~     portable cylinders and a newer method using a portable concentrator. The investigators~     hypothesise that oxygen levels during exercise will be significantly higher when using a~     portable cylinder, but this difference will be small.~   "
126864|NCT01906918|"~     Strategies for myocardial protection during open heart surgeries are desired. Several~     experimental studies have shown beneficial effects of remote ischemic preconditioning (RIPC).~     The underlying mechanisms are not totally understood. This study intends to evaluate~     molecular mechanisms involved with RIPC on myocardium of patients underwent open heart~     surgeries.~   "
126865|NCT01906905|"~     Trancranial Magnetic Stimulation (TMS) is a non-drug and non-invasive treatment for~     depression and has been investigated for the treatment of psychiatric illness for over 15~     years. There is now established evidence indicating TMS is an effective treatment for~     depression. However, the effectiveness of TMS varies between people, thus requiring further~     research to investigate its optimal application. Investigators want to compare the~     effectiveness of different forms of TMS, given with differing stimulation settings to the~     right or left side of the brain that has been associated with depression. This could~     potentially help clinicians in the future to improve the prescription of TMS as a treatment~     for depression.~   "
126866|NCT01906892|"~     This study explores the hypothesis that mental health service users, their carers and~     musicians can - through the creative act of music learning and performing - mutually enhance~     wellbeing through the development of more meaningful and resilient lives. The project seeks~     to explore three interconnected issues: (i) the extent to which music learning and performing~     provides a forum for 'mutual recovery' among adult mental health service users, their~     formal/informal carers, and musicians, (ii) the characteristic features of 'mutual recovery'~     through music, and (iii) the underlying mechanisms of such 'mutual recovery'.~      The study will consist of three different stages. Stages 1 and 2 will examine the effect of a~     variety of group activities - including participatory music, listening to live music,~     listening to recorded music and a non-music control - on psychological scales, saliva samples~     of stress hormones and cytokines, and subjective experience to see which provide the most~     relaxing, sociable and supportive environments for mutual recovery. Stage 3 will explore the~     impact of musical interventions over longer periods of time.~      A systematic review we have just carried out has revealed a major gap in research comparing~     different music interventions and testing the effects of different lengths of interventions.~     As a result, our study should help us answer the following questions:~        -  Which aspect(s) of music can contribute to mutual recovery?~        -  Do carers, patients and musicians all respond to the same activities, or do some musical~          activities suit certain groups more than others?~        -  Do carers, patients and musicians all recover at the same rate?~        -  What length of intervention is most effective?~      If certain interventions are found to produce stronger results than others, these results~     could help guide community groups and healthcare settings in their design of music activities~     and have implications for the spending of arts-in-health budgets.~   "
126867|NCT01906879|"~     Whether non-bismuth quadruple therapy (concomitant therapy) is more effective than bismuth~     quadruple therapy or triple therapy for 14 days remains unknown.~      Therefore, we aim to compare the eradication rates and long term re-infection rates of~     quadruple therapy for 10 days versus non-bismuth quadruple therapy for 10 days vs. triple~     therapy for 14 days.~      Methods: This will be a multi-center, open labeled, randomized control trial Patients: H.~     pylori infected patients who have willingness to receive eradication therapy~      Testing for H. pylori infection Before First Line Ttreatment~      (1)Any two positive of rapid urease test, histology, serology and culture or a positive UBT~     will be considered as H. pylori infected~      After First Line Treatment: C13-Urea breath test will be used to assess the existence of H.~     pylori 6-8 weeks after first line therapy.~      Long term reinfection: C13- Urea breath test will be used to assess the recurrence of H.~     pylori 1 year after eradication therapy~   "
126868|NCT01906866|"~     The purpose of this study is to establish the efficacy and safety of Circadin in children~     with neurodevelopmental disorders and to determine the dose, this randomized,~     placebo-controlled study is planned to evaluate the efficacy of a double-blind, 13 week~     treatment period with Circadin 2/5mg in improving maintenance of sleep, sleep latency and~     additional parameters in children with neurodevelopmental disabilities. The efficacy and~     safety of Circadin 2/5 mg will continue to be assessed during an open-label extension period~     of 13 weeks.~   "
126869|NCT01906853|"~     1. To determine if BCG immunisation at birth, compared to no BCG immunisation, leads to a~          reduction in measures of allergy and infection in the first 12 months of life.~        2. To evaluate the immunological mechanisms underlying the non-specific effects of BCG by~          comparing markers of immunity between the BCG and non-BCG groups.~   "
126871|NCT01906827|"~     The bile acids has been demonstrated to cause arrhythmia and abnormal calcium dynamics in~     cultured neonatal rat cardiomyocytes. Bile acids may alter maternal cardiomyocyte function~     like fetus.Increased P-wave duration and P-wave dispersion have been reported in various~     clinical settings. The investigators hypothesized that PWD and p wave duration may affect in~     pregnancy with ICP.~   "
126872|NCT01906814|"~     The purpose of this study is to determine whether 3 cycles of chemotherapy(CEV) are as~     effective as 6 cycles of chemotherapy(CEV) in the treatment of Stage I enucleated~     retinoblastoma.~   "
126873|NCT01906801|"~     The purpose of this study is to compare pain scores, WOMAC total and subscores, actual and~     change of joint space width and the rate of gastrointestinal side effects at 4, 8, 12, and 24~     weeks between dual-therapy of diacerein and glucosamine versus a mono-therapy of glucosamine~     in OA patients~   "
126874|NCT01906788|"~     The investigators' Hypothesis is that The correct timing of gametocytocidal drug in~     combination with an effective Artemisinin Combination Therapy can limit the infectiousness of~     malaria-infected individuals to less than one week after initiation of treatment~   "
126875|NCT01906775|"~     Implantable cardioverter defibrillators (ICD) may have the capacity to provoke or worsen~     ventricular tachyarrhythmias (VT). It has been reported that ICD shocks by itself can~     increase mortality. This study aimed to determine the role of back-up pacing-induced VT (PIT)~     to the overall ICD shock burden by avoiding pause-related ventricular back-up pacing by~     programming the pacing output to a sub-threshold level for ineffective pacing.~   "
126876|NCT01906762|"~     Kidney stone is one of the most common diseases in every human society and also Iran. What is~     normally used to treat renal colic pain is Intravenous Opioid with a variety of side effects~     including hypotension, respiratory depression and apnea, nausea and vomiting. Regarding less~     complications of Intravenous Acetaminophen, we aimed to compare it with Intravenous Morphine~     in management of renal colic pain.~   "
126877|NCT01906749|"~     Multicenter, double blind, randomized trial to assess the effect of low-dose colchicine~     (0.5mg/day) on overall mortality, new coronary syndromes, and ischemic stroke at 2 years~     after an acute coronary syndrome. The study hypothesis is that colchicine may reduce the~     specified combined endpoint from 16% to 7-8% at a 2-years follow-up.~   "
126878|NCT01906723|"~     Unstrained ambulation is the main goal of gait rehabilitation for preventing fatigue and~     increasing functionality in patients with gait deficiencies. The Up n' Free (Easy Walking) is~     a gait trainer equipped with a dynamic partial weight-bearing. The trainer is designed to~     provide the user with independence, safety, and endurance. It allows for easy transfer from~     sitting to standing position and stabilizes the pelvis, allowing for free movement of the~     hands. The effectiveness of the Up n' Free trainer in increasing the patient's functionality~     at the hospital or at home has not been quantified. We therefore aim to evaluate~     effectiveness of the gait trainer in increasing the functionality and spatiotemporal~     parameters of gait of 4 patients.~   "
126879|NCT01906710|"~     The purpose of this study is to determine whether a hospital pharmacy team (pharmacy~     technicians and pharmacists) together with (recently admitted) patients are able to diminish~     the number of drug related problems including adverse drug events, made before, during and~     after admissions resulting in reductions of re-hospitalizations and costs.~   "
126880|NCT01906697|"~     The aim of this study is to evaluate the effect of middle turbinate Radio Frequency (RF)~     turbinoplasty with middle turbinate resection and medialization~   "
126881|NCT01906684|"~     This study will determine changes in: 1) the immune activity, characterized as the~     immunorepertoire; 2) 7 Tesla MRI brain images; 3) clinical outcomes; and 4) patient~     reported quality of life outcomes in subjects with relapsing-remitting multiple sclerosis who~     are treated with Acthar Gel.~   "
126882|NCT01906671|"~     Acute lymphoblastic leukemia (ALL) accounts for 30 % of all childhood malignancies. The~     patients undergo four phases of treatment, finishing with a late maintenance phase in which~     6-mercaptopurine and Methotrexate are essential components. Insufficient treatment intensity~     in this phase is associated with increased risk of relapse. Excessive variation in the~     bioavailability of 6-mercaptopurine has been observed which can cause both risks of~     undertreatment/relapse as well as overtreatment with severe side effects.~      In the attempt to achieve individualized 6-mercaptopurine dosing different approaches have~     been pursued. Nonetheless variation in bioavailability remains a problem.~      Earlier, oral tablets of 50 mg (Purinethol) were the only administration form of~     6-mercaptopurine and it was primarily designed for adult patients. Challenges with accurate~     dosing and getting the children to swallow the tablets have been a widespread problem,~     forcing the caregivers to divide or crush the tablets as well as having to administer~     different dosages over 2-3 days. Due to these problems, an oral liquid formulation of~     6-mercaptopurine (Xaluprine) has been developed. However this oral liquid has only been~     tested on healthy adult volunteers, and not on the target group, childhood patients. This~     project will assess the bioavailability and plasma kinetics of oral liquid and tablet~     formulation of 6-mercaptopurine in children with acute lymphoblastic leukemia.~      The investigators hypothesize to observe comparable plasma kinetics, in children with acute~     lymphoblastic leukemia when treated with 6-mercaptopurine in the form of a tablet and oral~     liquid formulation, as previously observed in healthy adults.~   "
126883|NCT01906658|"~     This 8-week randomized, open-label evaluation will examine the acute safety and tolerability~     of 4 different dosing regimens of Acthar to inform dose selection for future studies of~     Acthar in patients with Amyotrophic Lateral Sclerosis (ALS). The study will also investigate~     the mean rate of change in the ALSFRS-R total score as an exploratory endpoint to help design~     future studies.~      This study will enroll up to 40 patients and include an optional 28-week open-label extension~     period plus a 3-week treatment taper and 1-week follow up period. After completion of Week 8,~     patients enrolled in a treatment group that is considered safe and tolerable at that time~     have the option to continue into the open-label extension period. A 3-week treatment taper~     and a follow-up visit are planned for all patients enrolled in the study, beginning either at~     Week 8 or at Week 36 if a patient continues into the optional open-label extension period.~   "
126911|NCT01906294|"~     This observation plan outlines the approach to build a diabetes registry to collect data on~     daily routine of treatment of Type 2 Diabetes Mellitus.~   "
126884|NCT01906645|"~     The purpose of this protocol is to evaluate the Care Transitons Innovation, a quality~     improvement project being implemented at OHSU to improve the transition from hospital to home~     for uninsured and Medicaid patients admitted to general medicine and cardiology wards at~     OHSU. The evaluation includes a baseline in-person survey and a 30 day post-discharge phone~     follow-up survey. Prior to C-TraIn, the local healthcare delivery model lacked an effective~     way to assure timely, safe, and effective follow-up care for uninsured and underinsured~     hospitalized patients. Most uninsured patients have no source for primary care, and many have~     limited social support, complex medical problems, and are prescribed many medications.~     Patients are frequently discharged without any coordinated plan for follow up. Based on a~     needs assessment performed in 2009 (OHSU eIRB 5514) investigators developed a quality~     improvement program that will include three major components: 1) a care transitions RN~     advocate who will see patients in the hospital and after discharge, 2) a pharmacy~     consultation and 30 days of medications post-discharge, 3) linkages with primary care medical~     homes, including payment for primary care for uninsured patients who lack a usual source of~     care, and 4) monthly meetings that serve as a platform for continuous quality improvement. In~     order to measure the success of our program, investigators will track patient utilization,~     sociodemographic factors, and patient factors including satisfaction, activation, and~     self-reported health status. To be included patients must be uninsured, have Oregon Medicaid,~     or be low income (200% or less of federal poverty level) Medicare recipients, and live within~     Multnomah, Washington and Clackamas Counties in Oregon.~   "
126885|NCT01906632|"~     To investigate gene expression profile and immunological associated analysis relating to~     immunotherapy response of patients with malignant tumor after DC-CIK immunotherapy.~   "
126886|NCT01906619|"~     Febrile seizures occur in 2-5% of the population and are typically limited to children~     between 3 months and 5 years-of-age. The pathophysiological link between increased body~     temperature and increased seizure susceptibility is unsolved in humans. In a mouse model it~     has been shown that young animals had a tendency to hyperventilate thereby causing~     intra-cerebral hypocapnia / alkalosis and a decrease of their seizure threshold. This effect~     was not observed in older animals. Redressing the pCO2 (carbon dioxide partial pressure) by~     breathing carbon dioxide enriched air instantly stopped the seizures.~      In this study the investigators want to investigate the respiratory physiology in children~     with febrile seizures and compare it to children who have fever but did not have febrile~     seizures.~      The investigators hypothesize that in children with febrile seizures the rising body~     temperature triggers a larger increase of respiratory rate (hyperventilation) and subsequent~     drop in pCO2 levels.~      This study could provide the basic physiological data for an interventional trial to test the~     efficacy of carbon dioxide inhalation to interrupt febrile seizures.~   "
126887|NCT01906606|"~     The purpose of the current study involves the development, implementation and evaluation of a~     parenting program to target maternal well-being and child health, growth and development in~     Lira, Uganda. The current study aims to address maternal care within a parenting program as~     well as parenting practices emphasizing nutrition, hygiene, and psychosocial stimulation~     through peer-support, practice and problem-solving. Outcomes include child health, growth and~     development, maternal mental health, mother-child interactions, and maternal-spousal~     relations.~      We hypothesize that:~        1. Children of parents who attend the parenting program will have better health, height and~          cognitive/language development at post-test, than children whose parents did not have~          the opportunity to attend parenting sessions.~        2. Parents who attend the parenting program will have more knowledge about child~          development and provide more home stimulation, dietary diversity and preventive health~          practices than parents who do not have the opportunity to attend parenting sessions.~        3. Mothers who attend the parenting program will have improved well-being compared to~          mothers who do not have the opportunity to attend parenting sessions.~   "
126888|NCT01906593|"~     To monitor the safety of Beijing Tiantan Biological's influenza vaccine in elderly through~     Adverse Events Following Immunization Surveillance System of China.~      The hypothesis is that there is no significant difference in the occurrence of adverse events~     among influenza vaccines manufactured by independent companies.~   "
126889|NCT01906580|"~     Currently, seven medications are approved for the treatment of hepatitis B: two formulations~     of interferon and five nucleons(t)ide analogues. The current treatment strategy of chronic~     hepatitis B is now standard: initial selection of entecavir, tenofovir, or peginterferon~     alfa-2a (peg-IFNα-2a). Interferon is administered for a finite duration while nucleotide~     analogues are usually administered for many years. But among hepatitis B e antigen （HBeAg）~     positive patients with high serum hepatitis B virus DNA levels, the rates of virological~     response are poor. And antiviral drug resistance is a major limiting factor to the success of~     nucleotide analogue treatment. Therefore, combination therapy using peginterferon with an~     oral agent with a high genetic barrier to resistance might be superior to standard current~     monotherapy. However, the addition of lamivudine to peg-IFNα-2a therapy led to a greater~     decrease in serum HBV DNA levels during treatment but did not increase the rate of HBeAg~     sero¬conversion. Entecavir is a nucleoside analogue superior to lamivudine and adefovir in~     achieving higher virological response, histological improvement and normalisation of ALT.~     Moreover, Entecavir has a high genetic barrier with a very low incidence of drug resistance.~     This study is aimed to investigate the efficacy of combination or sequential therapy using~     peg-IFNα-2a and entecavir in HBeAg-positive chronic hepatitis B(CHB) patients.~   "
126890|NCT01906567|"~     The purpose of this study, to investigate whether severity of preeclampsia is associated with~     altered levels of heavy metals (Cd, Hg, arsenic and Pb) in maternal blood, fetal blood, and~     maternal hair.~   "
126891|NCT01906554|"~     Eggs contain an essential nutrient called choline and adequate levels of choline are required~     for good health. Studies in mice have demonstrated that high levels of choline may increase~     risk of heart disease through a process that involves the breakdown of choline by gut~     bacteria. Previous research did not show that human consumption of eggs increases risk of~     heart disease. This study is designed to investigate whether the number of eggs in the diet~     affects blood and urine markers for heart disease.~   "
126912|NCT01906281|"~     Adipocytokines play an important role in joint inflammation in patients with knee~     osteoarthritis as measured by ultrasound and high sensitivity protein-C reactive.~     Adipocytokines could be the link between osteoarthritis and cardiovascular risk factors more~     prevalent in these patients.~   "
126892|NCT01906541|"~     X-linked chronic granulomatous disease (X-CGD) is a rare inherited immune defect, which is~     caused by the inability of phagocytic cells to produce reactive oxygen species due to a~     defect in the gp91phox subunit of the NADPH oxidase complex. X-CGD patients suffer from~     recurrent and life-threatening infections and severe hyperinflammatory complications.~      The only curative treatment for X-CGD is allogenic hematopoietic stem cell transplantation,~     but this procedure implies severe risks and many patients lack an appropriate donor.~     Therefore alternative curative approaches are urgently needed. In this study, patients will~     be treated with gene-corrected autologous CD34+ cells, using a SIN gammaretroviral vector for~     ex-vivo gene-therapy.~   "
126893|NCT01906528|"~     Muscle relaxants are drugs providing muscle relaxation during surgical treatment. Previous~     studies have shown that males and females respond differently to this kind of drug. Our~     hypothesis is that males are more sensitive to the effect of Mivacurium (a muscle relaxant)~     than females, meaning that males need a lower blood concentration of the drug than females in~     order to obtain a given effect.~   "
126894|NCT01906515|"~     Continuous and noninvasive hemoglobin (SpHb) monitoring provides clinicians with real-time~     trending of changes or lack of changes in hemoglobin, which has the potential to alter red~     blood cell (RBC) transfusion decision making. The objective of this study was to evaluate the~     impact of SpHb monitoring on RBC transfusions in high blood loss surgery. The investigators~     hypothesize that SpHb will improve blood transfusion practice in the for of change the number~     of blood unit per patient and improve the outcome regards the time to take decision of~     transfusion trigger.~   "
126895|NCT01906502|"~     A database (Snapfish) has been generated at Sensimed compiling all data acquired up to now on~     healthy volunteers and patients with glaucoma. However, healthy subjects were much younger~     than glaucoma patients. Additionally, the number of glaucoma patients in Snapfish database~     was almost twice higher than the number of healthy subjects. As it is generally accepted that~     intra ocular pressure (IOP) in the aging population is higher than IOP in young adults it is~     of interest to evaluate the 24-hour IOP pattern of older healthy subjects. Furthermore,~     improving our knowledge of the healthy 24-hour IOP pattern in comparison to glaucoma~     profiles would be beneficial for management of glaucoma.~   "
126896|NCT01906489|"~     The purpose of this study is to evaluate the hemoglobin response (efficacy), safety, and~     tolerability of orally administered AKB-6548 in patients with Chronic Kidney Disease~     (pre-dialysis) with anemia with dosing for 20 weeks.~   "
126897|NCT01906476|"~     This is a randomized, controlled trial comparing telephone-cognitive behavior therapy (T-CBT)~     with a therapist to a Stepped Care intervention for depression treatment (iCBT with support~     from a telephone coach with the possibility of being stepped up to receiving T-CBT with a~     therapist).~   "
126898|NCT01906463|"~     This study should also raise questions about the interest and feasibility of establishing a~     permanent registry of CVA in the Antilles and Guyana. Indeed in coming decades, the expected~     doubling of the population of persons aged over 60 years and the foreseeable changes in~     lifestyle will increase the burden of this disease, in particular since the region is marked~     by a high prevalence of arterial hypertension and diabetes and a high level of precarity. In~     addition, this study will provide epidemiological information on CVA, its risk factors and~     management, which are non-existent for the department of French Guyana where the health~     environment is manifestly insufficient. These data should make it possible to better evaluate~     the resources available and the healthcare needs in Guyana.~   "
126899|NCT01906450|"~     Human periodontitis is a group of highly prevalent oral inflammatory diseases and infections~     with relatively easy treatment and preventive features. The present study is aimed to~     determine if treating human individuals with chronic periodontitis, along with the use of~     antibiotics, reduces cardiovascular risk marker (HsPCR) and also intends to identify if~     severity of periodontitis could be associated with a raise of systemic inflammatory~     biomarkers on baseline.~   "
126900|NCT01906437|"~     A study to test the effectiveness of an investigational imaging technique for detecting~     cardiac injury after the administration of certain chemotherapies, such as doxorubicin.~     Investigational means that the imaging technique is still being studied and that research~     doctors are trying to find out more about it- such as whether the technique can detect lower~     levels of cardiac injury after treatment with doxorubicin. It also means that the FDA (the~     U.S. Food and Drug Administration) has not yet approved the use of gadolinium or approved the~     use of CMR studies for detection of cardiac toxicity after doxorubicin.~      The chemotherapy drug that you have been scheduled to be treated with, doxorubicin, has been~     associated with the development of heart failure in some patients. Cardiac Magnetic Resonance~     (CMR) is a type of MRI scan that uses a magnetic field to produce pictures of the heart. The~     CMR scan has been used in other studies and information from those other research studies~     suggest that this imaging technique may help to better detect differences in the structure of~     the heart muscle after treatment with doxorubicin. In this research study, we hope that we~     can better detect changes in the heart muscle after treatment with doxorubicin with a CMR~     scan in the hopes that cardiac injury can be detected and treated earlier to ultimately~     prevent the possible development of heart failure~   "
126901|NCT01906424|"~     This study is to determine if non-invasive electrical stimulation of the spinal cord can help~     improve hand and arm function in people with paralysis who suffered a cervical spinal cord~     injury.~   "
126902|NCT01906411|"~     The broad aim of the study is to obtain a better understanding of alterations in mesolimbic~     reward pathways in adiposity based on the hypothesis of a hypofunctioning reward system in~     obesity.~      This will be achieved by integrating a functional neuroimaging (fMRI) with behavioral reward~     tasks and the modulation of the dopamine level by dopamine depletion.~   "
126913|NCT01906268|"~     The objective of this project is to test the combination of active or placebo Attentional~     Bias Modification Treatment (ABMT) to usual treatment for anxiety disorder patients resistant~     to antidepressants.~   "
126938|NCT01905943|"~     This multicenter, open-label, single-arm study will evaluate the safety and efficacy of~     obinutuzumab alone or in combination with chemotherapy in participants with previously~     untreated or relapsed/refractory chronic lymphocytic leukemia (CLL). Participants will~     receive 6 cycles of single-agent obinutuzumab or obinutuzumab in combination with~     chemotherapy at the investigator's discretion. Each participant will be followed until 30~     months after the last participant has been enrolled. Total length of the study is anticipated~     to be approximately 5 years.~   "
126903|NCT01906398|"~     The purpose of the study is to obtain pilot data on safety and efficacy of ketogenic diet~     (KD) as adjunctive treatment of adults with refractory epilepsy. This will be an open label~     study comparing seizure frequency during 4 months of prospective baseline observation period~     with seizure frequency during 4 months of add-on KD treatment. 18-65 year old men and women~     with refractory epilepsy, defined as seizures persisting in spite of past/present treatments~     with ≥ 3 AEDs, with seizure frequency of ≥ 0.5/month, will be evaluated. Subjects with both~     primary generalized and localization-related epilepsy (PGE, LRE) will be recruited. Subjects~     will have had epilepsy for at least 2 years prior to enrollment. Following initial screening,~     subjects will be observed for 4 months, with no change in AEDs except when deemed necessary~     by the patient's neurologist according to standard clinical care. Patients will then start~     ketogenic diet. Evaluations will include seizure frequency using a seizure diary, adverse~     events, treatment compliance using urine and plasma ketone levels. Quality of life will be~     evaluated with a standardized questionnaire of Quality Of Life In patients with Epilepsy,~     QOLIE-31-P. Level of alertness will be evaluated with Epworth Sleepiness Scale. These~     questionnaires will be administered at each visit.~   "
126904|NCT01906385|"~     While radiation is an essential component to the treatment of glioblastoma, it's use is~     limited due to toxicity when higher doses are attempted. Rhenium is a compund which releases~     radiation in small particles that are absorbed after only a fraction of an inch. This limited~     penetration means that high doses potentially can be given without the toxicity of other~     forms of radiation. In order for the radiaiton to be retained within the tumor, it has been~     packaged in microscopic fat like particles termed nanoliposomes. These facilitate the uptake~     of the radiation particles by the tumor. In order to better characterize this form of~     radiation therapy, it is being administered in patients who have failed other forms of~     therapy for glioblastoma. The treatment is administered by tubing inserted into the center of~     the tumor in the operating room. There are two portionms to this study. The first involves~     progressively increasing doses until the most tolerable dose can be identified. The second~     portion of the study involves a larger number of patients being treated at the determined~     most tolerable dose to better evalaute how well the treatment works.~   "
126905|NCT01906372|"~     The purpose of this research study is to evaluate the effectiveness of the study drug, ACTH~     Gel in people diagnosed with dermatomyositis a disease that causes muscle weakness and is~     associated with a rash (DM) or polymyositis (PM) a disease that causes muscle weakness~     without a rash. The study doctors want to evaluate whether ACTH Gel will improve the symptoms~     of this disease. This drug is approved by the Food and Drug Administration (FDA) for~     dermatomyositis (DM) and polymyositis (PM). ACTH gel has been an FDA-approved treatment for~     myositis since 1952, and in 2010 the FDA retained PM and DM as diseases approved for ACTH gel~     use.~   "
126906|NCT01906359|"~     Type 2 diabetes mellitus (T2DM) is a chronic disorder determined by lifestyle and genes. It~     is associated with chronic hyperglycaemia along with other metabolic abnormalities. It is~     also one of the risk factors for cardiovascular disease (CVD). This disease is due to insulin~     resistance and/or deficiency as well as increased hepatic glucose output. According to the~     Third National Health and Morbidity Survey (3rd NHMS), the prevalence of T2DM for adults aged~     30 years and above is 14.9%, increased by almost 80% from 1996 to 2006. Dietary composition~     may affect insulin sensitivity, postprandial triacylglycerol concentration and the risk of~     T2DM. The role of dietary fats in T2DM is of particular interest and has been clinically~     studied for many decades. The type of fat we ingest every day consists of different types of~     fatty acids and different degree of saturation, which in turn influence glucose metabolism by~     altering cell membrane function, enzyme activity, insulin signalling and gene expression.~     Previous studies demonstrated that interesterification of dietary fat alter postprandial~     lipaemia. Saturated fat such as palm olein has been reported to display lower postprandial~     lipaemia after interesterification. Changing the structure of triacylglycerol (TAG) alters~     the physical properties of dietary fat which affects digestibility, metabolism and~     atherogenicity. A recent study conducted by Sanders and co-workers demonstrated reduced~     levels of plasma glucose-dependent insulinotropic polypeptide (GIP) following both the lard~     and interesterified palm olein (IPO) compared with the palm olein (PO) and high oleic~     sunflower oil (HOS) diets in healthy subjects. The GIP and glucagon-like peptide-1 (GLP-1)~     are major players in the modulation of postprandial insulin secretion by the pancreas.~     Although GIP secretion in response to meals is normal in patients with Type 2 diabetes~     mellitus (T2DM), GIP induced secretion of insulin is defective in diabetes. This is observed~     to be predominantly a defective stimulation of the late phase of insulin response (20-120~     minutes). The effect of IPO on GIP may be exaggerated in T2DM patients with impaired insulin~     sensitivity. Hence, IPO may change the concentrations of gut hormones, postprandial lipaemia,~     insulinaemic response and CVD related haemostatic markers.~   "
126907|NCT01906346|"~     Cocaine-use disorders continue to be a significant public health concern, yet no effective~     medications have been identified. The goal of this study is to establish a research platform~     for the development of medications for treatment of cocaine abuse and dependence. This study~     will incorporate self-administration procedures and a non-drug alternative reinforcer, which~     is hypothesized to reduce the reinforcing effects of cocaine.~   "
126908|NCT01906333|"~     There is increasing evidence that skeletal muscle lipid content (IntraMyoCellular Lipid,~     IMCL) markedly increases the risk of metabolic complications, including insulin resistance~     and cardiovascular events. The investigator hypothesizes that skeletal muscle is passively~     taking up FFAs when the availability is high, thereby leading to an increased storage. To~     test this hypothesis, the investigator wants to manipulate FFA levels, by means of exercise,~     and monitor intramuscular lipid content.~      Therefore the objective is to examine the effect of an exercise-induced elevation of FFA on~     skeletal muscle lipid content in healthy lean men. To this end, skeletal muscle lipid content~     will be investigated at baseline and after an exercise protocol and again after a four-hour~     recovery period from exercise, once in a condition with high FFA concentration, once with low~     FFA concentration. To achieve high- versus low FFA concentrations, an exercise protocol was~     chosen and participants had to perform this protocol once with a glucose supplementation and~     once without.~      Skeletal muscle lipid content will be determined before, directly after exercise and 4 h post~     exercise (from muscle biopsies) with or without glucose supplementation.~   "
126909|NCT01906320|"~     The aim is to test the hypothesis that high-resistance training for 8 weeks, following the~     recommendations for healthy adolescents, is capable of eliciting increases in muscle~     strength, agility, skeletal muscle mass, and functional capacity without losing weight, body~     mass index (BMI) or fat mass in anorexia nervosa restricting type patients. Further, we~     hypothesize that the effects produced by the high-resistance training program will be~     maintained 4 weeks following the completion of the training program.~   "
126954|NCT01905735|"~     the purpose of the study is to assess the safety and efficacy of commonly used Homeopathic~     medicine Rhustoxicodendron in 30 potency in the treatment of Rheumatoid arthritis.~   "
126914|NCT01906255|"~     This is an observational nested case control study among pre-exposure prophylaxis (PrEP)~     observational or clinical studies. The study will assess level of adherence as measured by~     drug level and its relationship to renal and bone adverse events, risk of seroconversion, and~     resistance development in subjects taking emtricitabine (FTC)/tenofovir disoproxil fumarate~     (TDF) (Truvada®) for PrEP.~      In the protocols of the parent PrEP observational or clinical studies, participants will have~     follow-up visits on average every 3 months for evaluation of adherence, HIV-1 status, renal~     and bone adverse events, and seroconversion. Adherence will be determined by the specific~     FTC/TDF drug level measurement(s) outlined in the parent protocol.~      There are two case definitions: a) One-hundred-fifty subjects who seroconvert (become HIV-1~     positive) and b) any subjects who either develop a protocol-defined renal adverse event~     (stratified by Division of AIDS [DAIDS] grading) or have a skeletal adverse event (any~     fracture) while taking FTC/TDF for PrEP.~      Among the estimated 7,000 subjects from Truvada for PrEP observational and clinical studies~     all cases, defined as subjects who seroconvert and/or develop either renal or skeletal~     adverse events, will be identified. Randomly chosen controls on Truvada will be selected in a~     3:1 ratio, from the same site, with a similar treatment duration.~   "
126915|NCT01906242|"~     Adequate denture hygiene is important to patient's oral health maintenance in particular~     because of Candida albicans, responsible for the development of denture stomatitis. The aim~     of this study is to conduct a randomized controlled trial seeking for the best hygiene~     protocols to be used in removable denture wearers. The null hypothesis tested is that there~     will be no difference among the denture hygiene protocols tested.~   "
126916|NCT01906229|"~     Acute respiratory distress syndrome (ARDS) is a devastating form of acute lung inflammation,~     that may be caused by a variety of insults with pulmonary and systemic infectious disease~     being the most common predisposing factor. Sepsis, on the other hand, represents the systemic~     inflammatory response to an invading pathogen, which may inflict damage upon the host through~     organ dysfunction. ARDS and sepsis are heterogenous clinical conditions that have a high~     mortality, and both diseases involve a complex interplay of different inflammatory mediators~     and cell types. It has been suggested that locally released inflammatory mediators pass from~     the lungs into the bloodstream following ARDS, triggering systemic inflammation. Conversely,~     it is possible that severe systemic inflammation may lead to ARDS by an influx of~     inflammatory mediators from the bloodstream to the lungs. However, the time course and the~     possible pathways for this transmission of disease have yet to be established.~      Investigators hypothesize that:~        1. Primary systemic inflammation is followed by a secondary pulmonary inflammatory response~        2. Primary pulmonary inflammation is followed by a secondary systemic inflammatory response~        3. Both primary and secondary inflammatory responses are characterized by the appearance of~          pro-inflammatory cytokines, inflammatory cells and production of collagen-like proteins~          (termed 'lectins')~        4. The inflammatory response is most pronounced in the primary afflicted compartment.~   "
126917|NCT01906216|"~     This prospective, multicenter, randomized, controlled study aims to evaluate the efficacy and~     safety of sorafenib combined with transarterial chemoembolization (TACE) in advanced~     hepatocellular carcinoma (HCC) patients compared with sorafenib alone, and to determine the~     prognostic factors that influence the survival.~      Data on the efficacy and safety of sorafenib in combination with TACE in patients with~     advanced HCC are lacking. Because in western countries, advanced HCC is considered as a~     contraindication for TACE treatment. However, clinical practice patterns differ markedly~     between Asia and western countries: in Asia TACE is performed in selected advanced HCC~     patients. We consider sorafenib combined with TACE could achieve better survival benefit than~     sorafenib alone in selected advanced HCC patients.~   "
126918|NCT01906203|"~     Prospective cohort, monocentric non-randomized and interventional clinical study in ICU~     assessing the evolution of body composition using bioelectrical impedance analysis.~   "
126919|NCT01906190|"~     This clinical study will be performed in subjects aged 12-60 years old enrolled in~     NCT01310374 who received 2010 seasonal influenza vaccine to evaluate the persistence of the~     immune response of influenza vaccine up to 24 months after vaccination.~   "
126920|NCT01906177|"~     The primary objectives of this pilot clinical study include:~        -  Evaluate clinical outcomes and quality of life on patients who received Vanguard PS~          Total Knee in Korean population~        -  Evaluate safety of Vanguard PS Total Knee in Korean population~   "
126921|NCT01906164|"~     This study will assess the safety, tolerability, and pharmacokinetics (PK) of orally~     administered ALS-008176 in healthy volunteers.~   "
126922|NCT01906151|"~     The purpose of the study is to determine the relationship of the intraocular pressure~     patterns recorded during 2 sessions using Triggerfish, before and after elective laser~     peripheral iridotomy in angle closure glaucoma patients~   "
126923|NCT01906138|"~     The purpose of the study is to determine the relationship of the intraocular pressure~     patterns recorded during 2 sessions using Triggerfish, before and after elective laser~     peripheral iridotomy in angle closure glaucoma patients.~   "
126924|NCT01906125|"~     This study is intended to establish the equivalence of 2 formulations to the intended final~     market product. The formulations to compare are the capsule given to patients in the phase I~     and II studies and the capsule that is being administered to the patients in the phase III~     trials. Both capsules will be compared to the intended final market capsule. The comparison~     will be performed looking at the pharmacokinetic parameters that define the rate and extent~     of absorption, those are Cmax and AUC. A statistical analysis will be performed comparing~     these parameters calculated after a single 125 mg dose of the 3 capsules identifying like~     that if there are significant differences between these 3 formulations.~   "
126925|NCT01906112|"~     The purpose of this study is to determine benefits of surgery for the primary in patients~     with breast cancer stage IV in randomized controlled study.~   "
126926|NCT01906099|"~     This randomized cross-over study was designed to investigate the effects of legume enriched~     diet consumption on cardiovascular risk factors among first degree relatives of diabetic~     patients.~   "
126927|NCT01906086|"~     The aim of this randomized cross-over study was to determine the effects of legume~     consumption on adiponectin and inflammatory factors among first degree relatives of diabetic~     patients~   "
126928|NCT01906073|"~     Today, patients with cancer pain in need of opioids for moderate to severe pain get~     long-acting morphine twice a day and morphine tablets taken on demand in addition. This~     procedure might be based on the assumption that cancer pain is persistent, although the~     evidence to support whether this assumption applies to all cancer patients is lacking. Some~     cancer patients might not need a fixed dose of long-acting morphine.~      Because of rapid pain relief, the new fentanyl drugs open for the possibility to take an~     opioid on demand when pain occurs.~      A pilot study where 10 patients with cancer pain were treated with a rapid-acting fentanyl~     nasal spray taken on demand, showed that this treatment was apparently feasible and safe for~     these patients.~      This approach is studied further in NFCP-II. The participants will be treated with~     rapid-acting fentanyl nasal spray and long-acting morphine in a crossover study. The primary~     outcome will be patient satisfaction.~      The study will consist of a test dose of nasal fentanyl, a dose-finding phase and a treatment~     phase with either nasal fentanyl taken on demand or slow-released morphine taken twice a day.~     After 10 days of treatment there is a crossover and the opposite drug is used for the same~     participant. Morphine tablets can be taken on demand in all phases of the study.~      The participants will meet the investigator at inclusion, at the crossover and at the end of~     treatment. During the study, a diary is filled in by the participants every morning.~     Questions about pain and side effects are answered. Satisfaction is measured at the crossover~     and at end of treatment while preference is measured at the end of treatment.~   "
126929|NCT01906060|"~     The disposable Air-Q self-inflating laryngeal intubation mask (Air-Q, Mercury Medical,~     Clearwater, FL, USA) is an extra-glottic airway device which enables blind intubation with a~     tracheal tube. This intubating laryngeal airway device (ILA) is already commercially~     available and worldwide certificated (CE 0482), but data about the success rates of blind~     intubation via this device in adult patients are lacking. Success rates of blind intubations~     with the non-self-inflating device range between 57 and 97%.~      Although the self-inflating disposable Air-Q device is certified for blind intubation, the~     success rate and rate of adverse events associated with this procedure have not been~     published so far. In a study comparing adverse events of conventional intubation with blind~     intubation via a different supra-glottic airway device (ILMA) the rates of sore throat and~     cough were comparable in both groups and were reported in 10-17% of the patients. In a pilot~     study using the non-self-inflating Air-Q for blind intubation in 19 patients, 10% reported~     dysphagia and one patient had a bilateral lingual nerve injury which was self-limited. One~     study using the self-pressurised disposable Air-Q for ventilation of children showed broncho-~     or laryngospasm in 3% and mucosal damage such as blood stained ILA or sore throat were~     reported in 1%.~      This data suggests that the rate of adverse events using the Air-Q supra-glottic device are~     comparable to other devices such as LMA.~        -  Trial with medical device~   "
126930|NCT01906047|"~     We aim at investigation the impact of chronic air pollution exposure on non-cystic fibrosis~     bronchiectasis outcome.~   "
126931|NCT01906034|"~     Background With increasing age neuromuscular deficits (e.g., sarcopenia) may result in~     impaired physical performance and an increased risk for falls. Prominent intrinsic fall-risk~     factors are age-related decreases in balance and strength / power performance as well as~     cognitive decline. Additional studies are needed to develop specifically tailored exercise~     programs for older adults that can easily be implemented into clinical practice. Thus, the~     objective of the present trial is to assess the effects of a fall prevention program that was~     developed by an interdisciplinary expert panel on measures of balance, strength / power, body~     composition, cognition, psychosocial well-being, and falls self-efficacy in healthy older~     adults. Additionally, the time-related effects of detraining are tested.~      Methods/Design Healthy old people (N = 66) between the age of 65 to 80 years will participate~     in this trial. The testing protocol comprises tests for the assessment of static / dynamic~     steady-state balance (i.e., Sharpened Romberg Test, instrumented gait analysis), proactive~     balance (i.e., Functional Reach Test; Timed Up and Go Test), reactive balance (i.e.,~     perturbation test during bipedal stance; Push and Release Test), strength (i.e., hand grip~     strength test; Chair Stand Test), and power (i.e., Stair Climb Power Test). Further, body~     composition will be analysed using a bioelectrical impedance analysis system. In addition,~     questionnaires for the assessment of psychosocial (i.e., World Health Organisation Quality of~     Life Assessment-Bref), cognitive (i.e., Mini Mental State Examination), and fall risk~     determinants (i.e., Fall Efficacy Scale - International) will be included in the study~     protocol. Participants will be randomized into two intervention groups or the control /~     waiting group. After baseline measures, participants in the intervention groups will conduct~     a 12-week balance and strength / power exercise intervention 3 times per week, with each~     training session lasting 30 min (without warm-up and cool-down). One intervention group will~     complete a supervised training program (2x supervised training per week / 1x home training~     per week), while the other intervention group will complete a training after the same~     protocol that is home-based (3x home training per week) and controlled by phone calls every~     two weeks. Post-tests will be conducted right after the intervention period. Additionally,~     detraining effects will be measured 12 weeks after program cessation. The control group /~     waiting group will not participate in any specific intervention during the experimental~     period, but will receive the extensive supervised program after the experimental period.~      Discussion It is expected that particularly the supervised combination of balance and~     strength / power training will improve performance in variables of balance, strength / power,~     body composition, cognitive function, psychosocial well-being, and falls self-efficacy of~     older adults. In addition, information regarding fall risk assessment, detraining effects,~     and supervision of training will be provided. Further, training-induced health-relevant~     changes, such as improved performance in activities of daily living, cognitive function, and~     quality of life, as well as a reduced risk for falls may help to lower costs in the health~     care system. Finally, practitioners, therapists, and instructors will be provided with a~     scientifically evaluated, feasible, safe, and easy-to-administer exercise program for fall~     prevention.~   "
126932|NCT01906021|"~     Background:~      - Ablation is a procedure that heats tumor tissue to a high temperature to destroy it.~     Doctors perform this procedure by putting a probe in the tumor. This delivers heat to the~     site. Currently, doctors tell what area is heated by using the probe s manufacturer~     estimates. These estimates are imprecise. Doctors insert small needles to measure the~     temperature around the area being heated. Doctors also perform scans of the area, but these~     cannot show which tissue has been heated and which has not. Right now, only contrast scans~     can show that. But researchers have developed software that uses images from routine scans to~     create a temperature map. They want to test the software to see if doctors can monitor the~     procedure without using more needles and without contrast scans.~      Objectives:~      - To test software that might help doctors perform ablations better in the future.~      Eligibility:~      - People over 18 years of age already scheduled to have an ablation.~      Design:~        -  Participants will be screened with a medical history.~        -  Participants will visit the clinic for their already-scheduled ablation. The doctor will~          use the study software to~      analyze the temperature in the area being heated. The software will not come into contact~     with a participant s body.~      - Participants will undergo scans that are necessary for the procedure, but one or two~     additional scans may be done as part of this study.~   "
126933|NCT01906008|"~     The goal of this clinical research study is to learn if minocycline can reduce numbness,~     pain, and/or loss of motor function in patients with colorectal cancer. In this study,~     minocycline will be compared to a placebo.~      The study doctor can explain how the study drug is designed to work.~      A placebo is not a drug. It looks like the study drug, but it is not designed to treat any~     disease or illness. It is designed to be compared with a study drug to learn if the study~     drug has any real effect.~   "
126934|NCT01905995|"~     Electrid activity of the basal ganglia will be recorded with an implantable deep brain~     stimulation device (supplied by Medtronic Inc).~      Study hypothesis is that these activities differ according to what the patient does, i.e. are~     different during gait and speech.~   "
126935|NCT01905982|"~     The purpose of this study is to determine whether different types of breathing therapies in~     patients with COPD III-IV decrease dyspnea, increase activity and have impact on~     parasympathetic activities.~   "
126936|NCT01905969|"~     Adjuvant chemotherapy followed by curative gastrectomy for Stage II/III gastric cancer has~     improved disease free time and survival. However, there are still considerable number of~     patients experience relapse even after adjuvant chemotherapy. In an attempt to select~     patients who really benefit the postoperative adjuvant chemotherapy, we have identified~     potential biomarkers (NF-kappaB/JNK) from cell line panel screening followed by~     immunohistochemical validation. In the present study, we further validate the significance of~     the biomarkers in a larger set of clinical samples to see if chemotherapeutic response can be~     determined immediately after surgery.~   "
126937|NCT01905956|"~     The individual ingredients in IQP-AK-102 have been widely used. Backed by data from several~     studies demonstrating their efficacy, we are conducting this study to look into the efficacy~     and safety of this novel combination of three fibres, in appetite regulation.~   "
126970|NCT01905514|"~     Nonadherence to immunosuppression is a leading cause of late graft rejection, chronic~     rejection and graft failure and it is regarded as a preventable cause of graft loss after~     solid organ transplantation. The purpose of this study is to evaluate whether mobile~     application for drug medication can enhance the drug adherence rate.~   "
126939|NCT01905930|"~     On October 26, 2012, the FDA granted Premarket Approval (PMA) for the PCM Cervical Disc. PCM~     Cervical Disc is indicated for use in skeletally mature patients for reconstruction of a~     degenerated cervical disc at one level from C3-C4 to C6-C7 following single-level discectomy~     for intractable radiculopathy (arm pain and/or a neurological deficit), with or without neck~     pain, or myelopathy due to a single-level abnormality localized to the disc space, and~     manifested by at least one of the following conditions confirmed by radiographic imaging (CT,~     MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of~     osteophytes), and/or visible loss of disc height as compared to adjacent levels.~      The purpose of this post-approval study is to evaluate the long-term (7 year) safety and~     effectiveness of the PCM Cervical Disc.~   "
126940|NCT01905917|"~     The primary hypothesis tested in this randomized control trial is that a tele-rehabilitation~     intervention involving video-conferencing with a therapist and use of wearable monitoring~     devices in the first three months after stroke results greater functional recovery using the~     Jette Late Life Functional and Disability Instrument (LLFDI) (primary outcome) among stroke~     at three months survivors compared to usual care.~      The secondary hypotheses tested in this randomized control trial are that a~     tele-rehabilitation intervention involving video-conferencing with a therapist and use of~     wearable monitoring devices in the first three months after stroke results in:~        -  Functional recovery using the LLFDI at 6 months,~        -  Functional recovery using gait speed, 2-minute walk test and Shah modified Barthel Index~          at 3 and 6 months,~        -  Greater contact time with a therapist at 3 & 6 months,~        -  Better balance at 3 & 6 months,~        -  Better self-report health-related quality of life at 3 & 6 months,~        -  Decreased health service utilization at 3 & 6 months,~        -  Reduced caregiver burden at three months survivors compared to usual care at 3 & 6~          months.~   "
126941|NCT01905904|"~     The purpose of the study was to investigate the effects of different doses of sevoflurane~     used in electroconvulsive therapy (ECT) on duration of seizure, hemodynamic response and~     recovery profiles~   "
126942|NCT01905891|"~     The purpose of this study is to correlate pathological features from specimens in order to~     determine if this new molecular diagnostic technique can be used to detect risk of skin~     cancer.~   "
126943|NCT01905878|"~     DLBS1033 is bioactive protein fraction which extracted from Lumbricus rubellus earthworm.~     This earthworm comes from Pengalengan, West Java, Indonesia. DLBS1033 possesses 8 major~     proteins with molecular weight below 100 kDa, so its named as Lumbricus Low Molecular weight~     Proteins (LLP). This enzyme can be transported to the bloodstream via intestinal epitel. As a~     drug that consists of serin protease enzyme, suspected that the mechanism of action of~     lumbrokinase, especially as fibrinolytic and antithrombotic. One study of DLBS1033 concluded~     that plasmin-antiplasmin (PAP) complex is a sensitive parameter for evaluating fibrinolytic~     effect of this drug. But, until now there is no clinical study that evaluate pharmacokinetic~     of this drug. As a pilot study, the aim of this study is to evaluate biological half life of~     DLBS1033.~   "
126944|NCT01905865|"~     Background:~      - Parents of a child with an undiagnosed medical condition face a lot of uncertainty. They~     may not know how to take care of their child or how the illness will affect their family~     life. Researchers want to study how these parents cope with and adapt to their child s~     condition in light of this uncertainty. Being uncertain can make it hard for parents to~     adapt. But it also might give them hope. Researchers want to study how uncertain the parents~     think their situation is and how that affects the way they think they can cope. Personality~     traits, like being able to handle uncertainty and being resilient, might also affect coping.~      Objectives:~      - To understand how having a child with an undiagnosed illness affects the way their parents~     think they can cope.~      Eligibility:~      - Adults with a child who has a medical condition that has not been diagnosed for at least 2~     years and involves at least 2 parts of the body.~      Design:~        -  Participants will answer survey questions for about 30 minutes. The questions are about~          their thoughts and feelings about having a child with an undisclosed illness.~        -  Participants can take the survey on paper or online.~   "
126945|NCT01905852|"~     Background:~      - Aortic valve stenosis is a disease that makes a major heart valve get smaller. This reduces~     heart function and causes death. Severe aortic stenosis (AS) can be treated in a couple of~     ways, including replacing a heart valve.~      Objectives:~      Researchers want to study fibrosis in the heart. A sub-study will test whether heart function~     and blood supply improve after a valve replacement.~      Eligibility:~      - Adults at least 18 years old with aortic stenosis.~      Design:~        -  Participants will visit a clinic for 1 day for magnetic resonance imaging (MRI) of their~          heart. This uses magnets, radio waves, and computers to produce detailed pictures of the~          heart.~        -  After this visit, participants will have their aortic valve procedure at the the~          Washington Hospital Center. A hospital team will contact participants for 1 year by~          phone or email. This follow-up will consist of 15 minutes of questions about the~          participant s health status.~        -  Some participants will join a sub-study.~        -  They will be given an additional medication to evaluate the blood supply of the heart.~        -  They will visit a clinic for 1 day for an MRI of their heart, as part of the main study,~          prior to the aortic valve replacement.~        -  After they have their valve replaced at the hospital, they will return to the clinic for~          another MRI.~        -  They will have the same follow-up as in the main study.~   "
126955|NCT01905722|"~     The overarching goal of this program project grant is the development of technologies that~     lead to new methods for studying, detecting, and treating type 2 diabetes, and their~     integration with hypothesis-driven diabetes research projects.~      Project 4 of the grant, led by Dr. Craig Malloy at UTSW, will develop and apply new~     technology in MRI to test core hypotheses about the development of insulin resistance in~     people. The long-term goal is to develop technology to monitor metabolism in skeletal muscle,~     brain and the liver using magnetic resonance imaging (MRI) and magnetic resonance~     spectroscopy (MRS) in a 3 Tesla and 7 Tesla MRI scanners. These advanced imaging methods~     allow researchers to take pictures of the inside of the body and to measure metabolism as it~     occurs in the MRI scanner. Standard clinical MRI for medical diagnosis and treatment is~     performed in a 1 Tesla or 3 Tesla MRI scanner.~      A primary goal of the 7 Tesla research program is to develop a group of protocols for~     investigating specific metabolic pathways in adipose (fat) tissue, skeletal muscle and the~     liver. This study is being done to improve methods of imaging and measuring molecules in a 3~     Tesla or 7 Tesla scanners.~   "
126946|NCT01905839|"~     Background:~      - Parkinson s disease (PD) affects half a million Americans, causing slow movements, tremors,~     stiffness, and trouble walking. Currently, these symptoms are measured by physical exam, but~     this is unreliable and requires an office visit. Researchers want to study a different way to~     measure PD symptoms, using a home-testing machine called a QMAT device. It can test how~     quickly someone moves doing different tasks. Researchers will study how this testing compares~     to physical exam testing and whether the device can detect changes in PD symptoms over time.~      Objectives:~      - To see if a home testing device can be used to evaluate Parkinson s disease symptoms.~      Eligibility:~      - Adults at least 18 years old with PD.~      Design:~        -  Participants will have about 22 clinic visits over 5 years. Each visit will take up to 3~          hours. Visits will be scheduled along with visits for another study.~        -  At visit 1, participants will learn to use the QMAT device and how to send testing~          information to the clinic by computer. The device has a computer screen, some buttons,~          and some pegs. Participants will get a device to take home and any accessories.~        -  Participants will learn 2 QMAT tests. For one, they will press keys as fast as possible.~          For the other, they will move pegs into holes. The tests will take a total of about 20~          minutes.~        -  Participants will take both tests at home, 2 times on the same day each week, once~          before their medication, once after.~        -  A study coordinator will monitor the participant s computer data and discuss the at-home~          testing at the clinic visits.~   "
126947|NCT01905826|"~     Background:~      - GATA2 deficiency is a genetic disorder that can cause problems with a person s immune~     system and other body systems. Some people who have this disorder develop few problems from~     it. Others can have a wide range of health problems, from skin problems, to hearing loss, to~     cancer. These problems can happen at any age. Researchers want to study GATA2 deficiency to~     better understand what types of health problems it can cause, and why it causes problems in~     some people but not others, and at different ages.~      Objectives:~      - To improve understanding of GATA2 deficiency so there can be better diagnostic tests and~     treatments in the future.~      Eligibility:~      - People 2 years of age or older who have a GATA2 gene mutation or certain health conditions~     that are commonly seen in people with this mutation and their blood relatives.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected to see whether participants have the GATA2 genetic mutation.~          Several other tests may be recommended, but participants can decline to take them.~        -  Participants will be eligible to receive standard care for GATA2 deficiency through this~          protocol. They may be eligible for other clinical trials at the National Institutes of~          Health as well.~        -  Participants will have regular study visits once a year to evaluate their GATA2~          deficiency. Participants will take part in the study for at least 3 years and up to 15~          years. At these follow-up visits, participants will fill out a questionnaire and take a~          physical exam and blood tests. Other tests may be performed as needed.~   "
126948|NCT01905813|"~     The study will be conducted in three parts. Part 1 is a dose escalation phase to determine~     the maximum tolerated dose (MTD) of INCB040093, a PI3Kδ inhibitor, or a tolerated,~     pharmacologically active dose; Part 2 will evaluate the combination of INCB040093 and~     itacitinib (INCB039110), a JAK1 inhibitor, to determine the MTD of the combination or a~     tolerated dose that produces substantial pharmacologic inhibition of both targets; Part 3~     will further evaluate the chosen doses of INCB040093 alone and in combination with itacitinib~     (INCB039110) in subjects with relapsed/refractory B-cell malignancies.~   "
126949|NCT01905800|"~     Benign paroxysmal positional vertigo (BPPV) represents the most common cause of labyrinthine~     vertigo with a lifetime prevalence of 2.4 percent. Onset is most common between the fifth and~     seventh decades of life. The disease can be a major handicap for the affected patient, and~     causes a great expense for society. The traditional manual treatment with repositioning~     maneuvers has greatly improved the possibilities for treatment of BPPV the last decade.~     However some patients are still difficult to diagnose and treat, and there are some who for~     health reasons cannot undergo traditional manual treatment. In this perspective there is a~     demand for a reliable, effective and precise method to treat all semicircular canals for the~     differentiated patient groups, and the techniques are under continuous development.~   "
126950|NCT01905787|"~     The purpose of this study is to take advance of the presence of two different cohorts of SCA~     patients in one country, the first group included SCA patients from Bedouin Arab origin that~     lives in Israel for more than one century and originally comes from African countries or~     Saudi Arabia, those patients lives in north east Israel and are treated at the Hematology~     Unit of the Emek Medical Center, the second group are SCA patients from African origin that~     come to Israel in the last decades and belong to original African population, this group~     receive treatment at the Pediatric Hematology Unit, Dana Children's Hospital, Ichilov Medical~     Center. A third group is a cohort of SCA patients treated at Schneider Children's Hospital~     Hematology Unit. Those patients belong also to the Israel Arab population and patients from a~     village that African Muslims live for many years. The characteristics of the three groups~     will be compared to the characteristics of a fourth group, a cohort of Afro-American SCA~     patients that are followed up and treated at the Pediatric Hematology Unit, Detroit~     Children's Medical Center, Detroit, Michigan, USA.~   "
126951|NCT01905774|"~     Thalassemia Major patients developed Iron Overload due to blood transfusions and intestinal~     iron absorption. Renal function caused by Iron overload was studied in a previous study and~     shows principally tubular disfunction. In this previous study the Iron chelator used was~     Deferrioxamine. In the last five years an oral Iron chelator was introduced and approved by~     the FDA, Deferasirox, (Novartis, Switzerland and USA). The purpose of this study is to assess~     the renal function in Thalassemia Major patients treated with this new oral iron chelator and~     compare the results with our previous study.~   "
126952|NCT01905761|"~     To systematically follow patients seen at the University of Minnesota's Lifestyle Medicine~     Program for Weight Management.~   "
126953|NCT01905748|"~     Acute Migraine attacks can be related to vascular or coagulation activation. Previous studies~     found relative high incidence of prothrombotic events in Migraine. The present study intends~     to assess the coagulation system and activation in patients with Migraine during steady state~     phase and at the beginning of attacks and after 72 hours. A control group of patients with~     another acute neurologic event like convulsions will be also studied. Patients will be at~     pediatric age and teenagers.~   "
126956|NCT01905709|"~     The objective of this study is to provide treatment with Fecal Microbiota Transplantation~     (FMT) to patients with recurrent or refractory Clostridium difficile infection (CDI). It has~     been shown that good bacteria (like that found in the stool from a healthy donor) attack~     Clostridium difficile in multiple ways: they make substances that kill Clostridium difficile~     - and they attach to the surface of the colon lining, which prevents the Clostridium~     difficile toxin (poison) from attaching.~      FMT involves infusing a mixture of saline and stool from a healthy donor into the bowel of~     the patient with CDI during a colonoscopy.~      The method used to deliver the FMT will depend on individual characteristics of the subject~     and is at the discretion of the treating physician. FMT may be administered by the following~     methods.~        -  Colonoscopy: This method allows full endoscopic examination of the colon and exclusion~          of comorbid conditions (such as IBD, malignancy or microscopic colitis) which may have~          an impact on subject's treatment or response to therapy.~        -  Sigmoidoscopy: This method still allows infusion of the stool into a more proximal~          segment of the colon than an enema, but may not require sedation. This method may be~          beneficial in subjects who are elderly or multiparous and who may have difficulty~          retaining the material when given as enema. Sigmoidoscopic administration eliminates the~          additional risks associated with colonoscopy in subjects who may not have a clear~          indication for colonoscopy.~        -  Retention enema: This method may be preferable in younger subjects who have already had~          recent endoscopic evaluation, in subjects who prefer not to undergo endoscopy or in~          subjects with significant co morbidities and may not tolerate endoscopy.~      The physician will administer 300-500 mL of the fecal suspension in aliquots of 60 mL,~     through the colonoscope or sigmoidoscope or 150 mL via retention enema. In cases of~     colonoscopic delivery, the material will be delivered to the most proximal point of~     insertion.~      The subject is encouraged to retain stool for as long as possible.~   "
126957|NCT01905696|"~     Nitric oxide is believed to contribute to regulation of blood flow by its selective binding~     to circulating hemoglobin (forming S-nitrosohemoglobin, SNO-Hb) and release in a~     PO2-dependent manner. This study is designed to test that hypothesis by measuring the effect~     of hypoxia and exercise on forearm blood flow before and after depletion of SNO-Hb using oral~     N-acetylcysteine.~   "
126958|NCT01905683|"~     The purpose of this study is to determine whether injections of Botulinum toxin type A into~     muscles of the leg(s) or of leg(s) and one arm are safe in treating children/adolescents (age~     2-17 years) long-term with increased muscle tension/uncontrollable muscle stiffness~     (spasticity) due to cerebral palsy.~   "
126959|NCT01905670|"~     The study is intended to demonstrate the safe implant of small receiver-electrodes into the~     endocardial surface of the left ventricle and to demonstrate its utility in providing cardiac~     resynchronization therapy in heart failure patients.~   "
126960|NCT01905657|"~     This study compared two doses of pembrolizumab (MK-3475) versus docetaxel in participants~     with non-small cell lung cancer (NSCLC) who had experienced disease progression after~     platinum-containing systemic therapy. Participants were assigned randomly to receive either~     pembrolizumab 2 mg/kg once every three weeks (Q3W), pembrolizumab 10 mg/kg Q3W or docetaxel~     75 mg/m^2 Q3W. This study used an adaptive trial design so that the total number of~     participants randomized depended upon demonstration of sufficient objective responses at an~     interim analysis.~      Protocol Amendment 12 (effective date: 09 Dec 2015) enabled eligible participants who were~     allocated to docetaxel and experienced disease progression, to be permitted to crossover to~     receive pembrolizumab 2 mg/kg Q3W as long as Inclusion/Exclusion criteria were met. These~     participants were participating in the Cross-Over Phase. With Protocol Amendment 15~     (effective date: 03 Jan 2018), all second course and crossover participants will receive~     pembrolizumab 200 mg Q3W. Also with Amendment 15, once a participant has achieved the study~     objective or the study has ended, the participant will be discontinued from this study and~     enrolled in an extension study to continue protocol-defined assessments and treatment.~     Crossover participants who have not transitioned to pembrolizumab will be considered for the~     extension study on a case-by-case basis.~      The primary study hypotheses are that pembolizumab prolongs Overall Survival (OS) and~     Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1~     (RECIST 1.1) by independent radiologists' review in previously-treated participants with~     NSCLC in the strongly positive programmed cell death ligand 1 (PD-L1) stratum compared to~     docetaxel and in participants whose tumors express PD-L1 compared to docetaxel.~   "
126961|NCT01905644|"~     The main objective of this study is to compare post partum rates of anal sphincter rupture~     (that is to say the rate of sutures) diagnosed in women with ≥ 2nd degree vaginal tears~     between two groups: (1) women who are screened just after delivery by performing a perineal~     ultrasound versus a similar group of women who did not receive screening. This study was not~     designed to evaluate ultrasound as a diagnostic test but to compare the rate of perineal~     surgical procedures in each arm.~   "
126962|NCT01905618|"~     This study compares two methods of teaching the 5As (Ask, Advise, Assess, Assist, Arrange)~     for tobacco dependence treatment to medical students: 1) traditional medical education (TE),~     and 2) multi-modal education (MME). The MME arm builds upon the traditional curriculum at the~     medical school by providing a web-based instructional program, a role play, preceptor~     training, and a booster session. The hypotheses are that MME will outperform TE on observed~     5As counseling skills on the Objective Structured Clinical Exam (OSCE); and MME will~     outperform TE on self-reported 5As counseling skills.~   "
126963|NCT01905605|"~     Sensory gating is defined as the automatic process of inhibiting brain response to repeated~     auditory sounds. Infants who brains respond similarly to two identical sounds presented about~     1/2 second apart are more likely to have later problems with attention than infants who~     suppress response to the second sound. This study will examine whether providing a~     nutritional supplement, phosphatidylcholine, for two months in infancy will result in an~     increased likelihood of developing more robust sensory gating.~   "
126964|NCT01905592|"~     The purpose of this study is to compare progression-free survival (PFS)in patients with~     advanced/metastatic breast cancer who have a BRCA gene change when treated with niraparib as~     compared to those treated with physician's choice~   "
126965|NCT01905579|"~     The purpose of this study is to compare flaremetry readings with the protein content of the~     aqueous humor and the clinical grading of flare.~   "
126966|NCT01905566|"~     Objectives: To compare the effects of clopidogrel versus ticagrelor on atherosclerotic plaque~     inflammation using serial FDG PET/CT imaging of carotid artery and ascending aorta.~      Hypothesis: Thrombosis and inflammation are tightly linked rather than separate entities.~     Therefore, P2Y12 receptor inhibitors may have an anti-ischemic effect by inhibiting plaque~     inflammation, and ticagrelor may be superior in efficacy to clopidogrel.~   "
126967|NCT01905553|"~     To assess the effect of food on the pharmacokinetic profile of SSP-004184 compared to~     administration under fasted conditions.~   "
126968|NCT01905540|"~     This study will evaluate the relative bioavailability of the new SSP-004184SS capsule~     formulation compared to the original SSP-004184AQ drug plus excipients formulation.~   "
126971|NCT01905501|"~     This study aimed to evaluate the possible protective effect of anesthetic technique~     balanced(with sevoflurane) compared with total intravenous anesthetic technique~     (propofol,remifentanil). The hypothesis is that the Sevoflurane may exert protective effect~     in regard to the ischemia-reperfusion injury induced on the microsurgical breast free flap~     during transfer to receiving area. The investigators will evaluate the continuous flap tissue~     oximetry and the level of biochemical markers.~   "
126972|NCT01905488|"~     Internal jugular vein (IJV) is the main pathway of cerebral venous drainage and it has valve~     system to prevent retrograde blood flow to the brain. Anatomical studies revealed that~     bicuspid or tricuspid valves were located in both jugular veins 2 cm above the~     subclavia-jugulars bifurcation and 7-18% of the valves were incompetent. IJVV incompetence~     (IJVVI) may result in retrograde flow which leads to brain congestion and increase of~     intracranial pressure, which can cause brain dysfunctions in some patients. IJVVI has been~     reported to be associated with transient global amnesia (TGA), cough syncope, exertional~     headache, transient ischemic attack, and air embolism. Demographic data are associated with~     the development of IJVVI. Akkawi et al. demonstrated that old age over 50 years and male~     gender are the risk factors for IJVVI. A few physiologic conditions are related with IJVVI~     including elevated intra-thoracic and intra-abdominal pressure, and pulmonary hypertension.~     Robot assisted laparoscopic prostatectomy (RLP) is one of the most common robotic surgery~     because of its significant benefits such as smaller incision, less severe postoperative pain,~     less intraoperative bleeding, and shorter hospital stay compared to traditional radical~     prostatectomy. The patients undergoing RLP are mostly over 60 years old, have neurologic,~     cardiac and pulmonary comorbidities. For RLP, patients are in Trendelenburg position most of~     the time during surgery, which could cause increases in intra-abdominal and intrathoracic~     pressure.~   "
126973|NCT01905475|"~     The purpose of this study is to investigate the effects of POL6326 (CXCR4 antagonist) as a~     stem cell mobilizing agent, on cardiac function and infarct size and on safety and~     tolerability, in patients with reperfused ST-Elevation Myocardial Infarction (STEMI).~   "
126974|NCT01905462|"~     This study will assess the risk of spontaneous abortion during weeks 1-23 and weeks 1-19 of~     gestation, respectively, and other pregnancy outcomes, in an exposed cohort, i.e. women with~     last menstrual period (LMP) between 30 days before and 45 days after, or 30 days before and~     90 days after any dose of Cervarix, when compared to a non-exposed cohort, i.e. women with~     LMP between 120 days and 18 months after the last Cervarix dose. The data collected in the~     Clinical Practice Research Datalink General Practitioner OnLine Database (CPRD GOLD) in the~     UK, will be analysed in this study.~   "
126975|NCT01905449|"~     Children with speech sound disorders will receive speech therapy using real-time images of~     the tongue from ultrasound. These images will be used to cue the child to change the tongue~     position when producing speech sounds.~   "
126976|NCT01905436|"~     Approximately 5,200 people will participate per year. The study population will include~     females and males over 5 years of age who live in filariasis and onchocerciasis endemic~     areas. Subject selection will not be based on health status.~      Two sites will be studied, and each study will last for 4 years. Participants will be studied~     only once in cross-sectional surveys. Some subjects may be included in more than one annual~     population survey, but this is not a longitudinal study.~      Investigators will compare annual and semiannual mass drug administration (MDA) for lymphatic~     filariasis and onchocerciasis, and investigators will compare the impact of these MDA~     schedules on soil transmitted helminth infections. MDA will be administered by others~     (Liberian Ministry of Health or Liberian Institute of Biomedical Research).~      The investigators will test the hypothesis that semiannual mass drug administration (MDA) is~     superior to annual MDA for elimination of lymphatic filariasis, onchocerciasis and for~     control of soil transmitted helminth (STH) infections.~        1. Compare the relative impact and cost effectiveness of annual vs. twice yearly mass drug~          administration (MDA) for elimination of lymphatic filariasis (LF) in these populations.~        2. Compare the relative impact and cost effectiveness of annual vs. twice yearly mass drug~          administration (MDA) for elimination of onchocerciasis in these populations.~        3. Study the impact of annual vs. semiannual MDA on soil transmitted helminth (STH)~          infection in these populations.~   "
126977|NCT01905423|"~     Approximately 3,500 people will participate per year. The study population will include~     females and males over 5 years of age who live in filariasis endemic areas. The study will be~     performed in Indonesia in B. timori and W. bancrofti endemic areas over a period of 4 years.~     Participants will be studied only once in cross-sectional surveys. Some subjects may be~     included in more than one annual population survey, but this is not a longitudinal study.~     Purpose of the study is to evaluate different mass drug administration (MDA) regimens for~     lymphatic filariasis and also to study the impact of MDA on soil transmitted helminth~     infections (STH). MDA will administered by others (e.g., Ministry of Health). Results of this~     study may enhance efforts to control and eliminate these important neglected tropical~     diseases.~      The investigators will test the hypothesis that accelerated mass drug administration will be~     superior to annual MDA for elimination of lymphatic filariasis and for control of soil~     transmitted helminth infections (STH):~        1. Compare the relative impact and cost effectiveness of annual vs. twice yearly mass drug~          administration (MDA) for elimination of lymphatic filariasis (LF).~        2. Study the impact of annual vs. semiannual MDA on soil transmitted helminth (STH)~          infection in these populations.~   "
126978|NCT01905410|"~     VVZ-149 is a novel analgesic drug candidate that shows a potential analgesic activity~     inhibiting GlyT2 and 5HT2A simultaneously. There have been many efforts to develop~     single-target selective drugs to treat pain, but usually unsuccessful due to the lack of~     efficacy or limitations of single-target approach for new drug discovery. VVZ-149 is expected~     to have a dual-target activity, demonstrated having a synergism between GlyT2 and 5HT2A~     antagonistic activities to maximize an antinociceptive effect in the in vivo animal models.~     Now the investigators are developing VVZ-149 as an IV injection to treat post-operative pain.~      The primary objective of this study is to evaluate a safety, tolerability and pharmacokinetic~     properties of VVZ-149 injection with placebo in healthy male volunteers. This Phase 1 study~     consists of a randomized, double-blind, placebo controlled, single and multiple ascending~     dose (SAD & MAD) escalation clinical trials.~   "
126981|NCT01905371|"~     This is an NIH Pilot Clinical Trial Grant designed to provide data to permit the rationale~     design of a subsequent efficacy study. The purpose of this project is to determine the~     potential benefit of amphetamine combined with physical therapy in enhancing motor recovery~     in patients admitted for inpatient rehabilitation between 10 and 30 days after hemispheric~     ischemic stroke. The study hypotheses are: 1, The addition of treatment with d-amphetamine~     will result in at least a 12.6 point improvement in the Fugl-Meyer motor score 3 months after~     stroke. 2, There will be no clinically significant increase in the frequency of serious~     adverse events associated with treatment with d-amphetamine which would preclude further~     testing.~   "
126982|NCT01905358|"~     The purpose of this prospective data collection is to track patients who are treated at HSS~     who are confirmed with knee osteoarthritis. The registry will collect prospective patient~     related and functional outcomes (including use of assistive devices), medication use and~     imaging data on patients with confirmed osteoarthritis, and the effect of different medical~     interventions that include PRP, Synvisc / Orthovisc /Euflexxa, bracing, suggested exercises,~     supplements, and diet. Information from the data collection will be used to compare outcomes~     of non-surgical alternatives with the end point being knee arthroplasty. The information~     results will enhance our knowledge of the long-term efficacy and effectiveness of~     non-surgical interventions intended to treat the progression of osteoarthritis.~      Hypotheses:~        -  Different non-surgical interventions such as PRP, Synvisc®, Orthrovisc®, Euflexxa,~          bracing, physical therapy, and a prescribed combination of exercise, diet, and~          supplements will demonstrate statistically significant differences in patient pain and~          functional outcomes compared to usual interventions including use of NSAIDs,~          corticosteroid injections, and use of assistive devices such as canes.~        -  Non-operative interventions for knee osteoarthritis will be associated with different~          rates of breakdown of articular cartilage and different rates of progression of~          osteoarthritis as evidenced by MRI or joint space narrowing on standing knee films?~        -  Education about available non-operative treatment methods may change time the end point~          of total or partial knee replacement for patients with knee osteoarthritis of varying~          severity.~        -  Different non-operative interventions will be associated with different times to total~          or partial knee arthroplasty in patient with knee osteoarthritis of similar severity.~        -  An electronic data capture system (EDC) for osteoarthritis patients will improve patient~          care and patient outcomes.~   "
126983|NCT01905345|"~     Randomised training intervention.~      Influence of consecutive training regime on the impact of the myonuclear domain and satellite~     cell~      Sarcopenia~      Despite that the muscle mass can be positively influenced by training, the loading with high~     weights and/or to the total exhaustion is for many old persons not possible.~      Therefore we aim to enhance the myonuclei in the muscle fiber of old male subjects in a first~     phase by endurance training, in order to promote a more effective muscle growth in a second~     phase by resistance exercise.~   "
126984|NCT01905332|"~     This study's aim is to validate a parent-completed brief literacy screening tool (Early~     Literacy Screener) at the 4 year well child check using the Get Ready to Read- Revised~     screening tool as a gold standard. Four year old children who fall below the cutoff score for~     the GRTR-R will be randomized to either receive current standard of care (control group) or a~     referral to receive a 6 month home based literacy promoting program (intervention group).~     After 6 months, both groups will be retested using the GRTR-R. The hypothesis is that the~     change in raw scores on the GRTR-R in the intervention group after 6 months will be greater~     than the change in raw scores in the control group.~   "
126985|NCT01905319|"~     Aims of the study:~        -  to study the incidence rate of juvenile idiopathic arthritis (JIA) and it's clinical~          subtypes in Estonia for the years 1998-2000;~        -  to examine the course and short-term clinical outcome of JIA.~      Method: a prospective population-based study carried on in 14 counties of Estonia~   "
126986|NCT01905306|"~     This clinical study has the objective to compare the radiographic evaluations after 3 years~     of follow-up of immediate loaded implant-prosthetic rehabilitation, carried out randomly~     using the methodology for computer guided implant planning with software polyvalent or free~     hand implants placement.~   "
126987|NCT01905293|"~     The portion size of foods has been identified as an important determinant of energy intake in~     children. It remains to be determined to what extent child weight status and the relative~     reinforcing value of food may interact with the obesogenic food environment to affect energy~     intake. The primary aim of this study was to compare energy intake at a meal in normal-weight~     and obese children when the portion size of palatable, energy-dense foods and a~     sugar-sweetened beverage was systematically increased. We hypothesized that increasing the~     portion size of all foods and the beverage at a meal will lead to a significant increase in~     energy intake in both normal-weight and obese children. Obese children, however, will show a~     significantly greater increase in energy intake than will normal-weight children. A second~     aim of this study was to test if children's response to increases in portion size was~     affected by how reinforcing they find food to be. We hypothesized that, when controlling for~     BMI, children who find food very reinforcing relative to nonfood alternatives will show a~     significantly greater increase in energy intake than will children who find food less~     reinforcing.~   "
126988|NCT01905280|"~     The purpose of this study is to compare the clinical and histologic outcomes for acellular~     dermal matrix and a nonresorbable membrane to determine if either provides a significant~     therapeutic advantage. The hypothesis is that there will be no difference in crestal ridge~     width between the two treatments.~   "
126989|NCT01905267|"~     The Pediatric Mood Disorders Program at the University of Illinois at Chicago is conducting a~     research study examining how mindfulness can help teenagers stay healthy and prevent~     depression relapse.~   "
126990|NCT01905254|"~     Recent, research has focused on the evaluation of non-invasive methods for the assessment of~     liver fibrosis in patients with chronic liver disease. Among these methods, transient~     elastography is the most promising. The method has been investigated mainly in patients with~     viral hepatitis. Several studies have shown, that the optimal cut-off value of TE for~     detection of liver cirrhosis by transient elastography is highly dependent on the aetiology~     of the underlying liver disease. Only a few studies have evaluated the value of transient~     elastography for patients with autoimmune liver disease and here primarily patients with PBC~     and PSC. For patients with autoimmune hepatitis the data is limited. We prospectively~     investigated the diagnostic accuracy of TE in autoimmune hepatitis compared to liver~     histology with and without inclusion of the macroscopic appearance using mini-laparoscopy~   "
126991|NCT01905228|"~     The primary objective of the study is to determine the maximally tolerated dose and~     recommended Phase 2 dose of CBL0137 when administered intravenously (IV) to patients with~     metastatic or unresectable advanced solid malignancies.~   "
126992|NCT01905215|"~     The purpose of this first time in human (FTiH) study is to evaluate the safety,~     reactogenicity and immunogenicity of several formulations of Respiratory Syncytial Virus~     (RSV) investigational vaccines in healthy men.~   "
126994|NCT01905189|"~     Pulmonary arterial hypertension is a disease characterised by pathological changes in the~     pulmonary arteries leading to a progressive increase in pulmonary vascular resistance and~     pulmonary artery pressure. Right ventricular failure is the main cause of death in patients~     with pulmonary arterial hypertension, and the ability of the right ventricle to adapt to the~     progressive increase in pulmonary vascular resistance associated with changes to the~     pulmonary vasculature in pulmonary arterial hypertension is the main determinant of a~     patient's functional capacity and survival.~      Right ventricular dyssynchrony was present in a substantial proportion of patients with~     pulmonary arterial hypertension and this dyssynchrony adversely affected right ventricular~     function.~   "
126995|NCT01905176|"~     The current trial aims to examine the effectiveness of three different types of nursing~     interventions, on heart failure (HF) patients' quality of life and on HF outcomes, compared~     to the usual care. The interventions include promotion of self-care practices through~     education and support; they are either provided before discharge, post-discharge through~     telephone, or both.~   "
126996|NCT01905163|"~     This prospective nonrandomized multicenter phase II study, will evaluate the possibility of~     performing a laparoscopic interval debulking after a minimum of 3 cycles of chemotherapy in~     highly chemo-sensitive patients with advanced ovarian, tubal cancer or primary peritoneal.~   "
126997|NCT01905150|"~     Pancreatic cancer, especially at advanced metastatic stage, is a devastating disease. It is~     the fourth leading cause of cancer death. Its prognosis is grim - 5-year survival rate being~     6%. The current therapies for advanced metastatic pancreatic cancer are very toxic and with~     limited efficacy. A safer and more effective therapy for this devastating disease is greatly~     needed.~      G-FLIP regimen is a combination of low doses (doses lower than those approved by the FDA and~     used in the clinic) of several anti-cancer drugs, Gemcitabine, Fluorouracil, Leucovorin,~     Irinotecan and Oxaliplatin. The efficacy of G-FLIP against cancers (especially pancreatic~     cancer) is based on laboratory and clinical results, which indicates the synergistic efficacy~     of these anti-cancer drugs against cancer cells and overcoming tumor drug resistance that~     cancer cells frequently develop. Also, because of their low doses, this regimen is less toxic~     than when these drugs are used alone.~      Meanwhile, intravenous infusion of high doses (doses significantly higher than the daily~     nutritional requirements) of Vitamin C (ascorbic acid) has been observed to have anti-cancer~     activities. This is especially true when Vitamin C is used in combination with other~     anti-cancer drugs.~   "
126998|NCT01905137|"~     The purpose of this study is to determine whether there is a change in patient-reported~     pelvic pain following pelvic floor injections of 200 units of Botox compared with 20cc of~     normal saline.~   "
126999|NCT01905124|"~     This is a Phase 2, randomized, double-masked, placebo-controlled study subjects with active,~     sight-threatening, noninfectious intermediate or posterior uveitis.~   "
127000|NCT01905111|"~     The primary objective of this trial is to explore the safety and tolerability of BI 853520~     monotherapy and determine the maximum tolerated dose (MTD) for Japanese and Taiwanese~     patients with advanced or metastatic solid tumours.~      Secondary objective is collection of preliminary data on anti-tumour efficacy~   "
127001|NCT01905098|"~     The purpose of this study is to determine the impact of sauna use on polychlorinated~     biphenyls (PCB) in the blood of healthy human adults, as well as to assess safety,~     feasibility, and tolerability, and effects on quality of life and wellness. We hope to~     determine if there is a link between lower PCB levels in blood and sauna use.~   "
127002|NCT01905085|"~     Indirect calorimetry is valuable in determining resting energy expenditure in infants,~     children and adults. This measure will estimate the number of calories needed per day under~     resting conditions.~      Adding physical activity measures will help estimate total energy requirements in~     individuals. With the rise in obesity, numerous programs of prevention are being developed.~     Being able to characterize carefully energy intake and energy expenditure is one of the~     challenges of most of these initiatives.~   "
127003|NCT01905072|"~     The goal of this study is to compare the effectiveness of structured CHW- provided home~     visits, using an intervention created through community-based participatory research, to~     standard care received through WIC office visits in preventing the development of overweight~     (weight/length >85th percentile) and obesity (weight/length >95th percentile) in infants~     during their first 2 years of life.~      Hypothesis 1: Children in the intervention group will remain within their growth centiles in~     height/weight and weight for age, while children in the control group will increase in~     height/weight percentiles and weight percentiles more rapidly (> .67 SD) during the first~     year of life.~      Hypothesis 2: Fewer children who receive the intervention will have BMI >95th percentile at~     ages 2 and 3 than the children in the control group.~      Hypothesis 3: Children who receive the intervention will exclusively breastfeed for a longer~     period of time than will children in the control group.~      Hypothesis 4: Children who receive the intervention will have a higher percentage of fruits~     and vegetables and a lower percentage of sweetened beverages, desserts, and candy in their~     diets at ages 1, 2, and 3, than will children in the control group.~      Hypothesis 5: Parents in the intervention group will be more responsive to infant feeding~     cues (hunger, satiety)than parents in the control group.~   "
127004|NCT01905059|"~     Multicenter, randomized, superiority trial to evaluate efficacy of a mono or bi-therapy of~     protease inhibitors with or without lamivudine over a period of 96 weeks. The primary outcome~     will be the failure rate at 96 weeks. This study will include 260 participants, former~     participants of the 2LADY trial. It will be carried out in Yaoundé, Bobo Dioulasso and Dakar.~   "
127005|NCT01905046|"~     This randomized phase III trial studies metformin hydrochloride to see how well it works~     compared to placebo in preventing breast cancer in patients with atypical hyperplasia or in~     situ breast cancer. Chemoprevention is the use of certain drugs to keep cancer from forming.~     The use of metformin hydrochloride may prevent breast cancer.~   "
127018|NCT01904877|"~     1. The number of MSM who are tested for HIV in the 4 study clinics over 12 months will~          increase compared with historical data from the same 4 clinics over the past 12 months~          prior to the intervention.~        2. Persons diagnosed with HIV over the duration of 12 months will have higher CD4 counts at~          diagnosis than persons diagnosed with HIV over the past 12 months prior to the~          intervention~   "
127006|NCT01905033|"~     Background: Sepsis is a major cause of in-hospital morbidity and mortality. Current tools~     available to the clinician to initiate therapy of patients with sepsis mainly comprise of~     symptom classification systems and culture techniques, which provide aspecific and slow~     information.~      Objective: The ultimate goal of this program is to assist the physician at the bedside in~     tailoring the treatment of an individual patient suffering from sepsis by generating rapid~     molecular information about the causative pathogen and the host response.~      Deliverables: Rapid tests (sample-in-result-out) that can be used by health care personnel~     at or close to the bedside and that provide rapid information (within two hours) about the~     presence or absence of sepsis, the causative pathogen and the risk of the individual patient~     for sepsis complications and death.~      Design: The program is organized into four Work Packages (WPs) along a clinical, discovery~     and technology platform. In WP1 two university hospitals will enroll 7500 patients admitted~     to the Intensive Care Unit during the first 3 years of the project; 25% - 40% of these~     patients will have or will develop sepsis. In WP2 (Pathogen Detection), blood obtained from~     these patients will be used to develop rapid, fully automated DNA-based bedside tests that~     identify microorganisms and also provide information about their resistance to antibiotics.~     In WP3 (Host Response), RNA from blood cells will be analyzed to find novel biomarkers and to~     develop rapid and easy to perform tests that provide information about the risk profile of~     the patient. In addition, plasma levels of selected protein biomarkers will be measured for~     comparison of their value with that of the identified leukocyte molecular signatures. WP4 is~     responsible for the ICT management of the project. The Clinical Platform (covered by WP1 and~     WP4) delivers patient data and biological samples to the discovery and technology platforms.~     The Discovery Platform (covered by WP2 and WP3) uses patient data and biological samples to~     develop tests for detection of the infectious agent causing sepsis and for stratification of~     patients according to their risk for sepsis complications, including death. The results~     generated within the discovery platform will be delivered to the technology platform. The~     Technology Platform (part of WP2 and WP3) has the specific aim to develop rapid assays that~     run on a fully automated (micro)fluidics platform that is so easy to operate that it can be~     used in decentralized settings such as (close to) the ICU. The developed assays will make use~     of the knowledge generated in the discovery platform.~   "
127007|NCT01905020|"~     Closed-loop strategy is composed of three components: glucose sensor to read glucose levels,~     insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required~     insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would~     regulate glucose levels through the infusion of two hormone: insulin and glucagon.~      The main objective of this project is to compare the efficacy of single-hormone closed-loop~     strategy, dual-hormone closed-loop strategy and pump therapy to regulate overnight glucose~     levels in a out-patient study in adults and adolescents with type 1 diabetes.~      The investigators hypothesized that dual-hormone closed-loop strategy is more effective in~     regulating overnight glucose levels in adults and adolescents with type 1 diabetes compared~     to single-hormone closed-loop strategy, which in turn is more effective than the conventional~     pump therapy.~   "
127008|NCT01905007|"~     The primary objective of this study is to compare the composite outcome of total mortality~     and operative complications in patients who do not undergo defibrillation testing to those~     who do undergo defibrillation testing at the time of initial ICD implantation.~   "
127009|NCT01904994|"~     Despite increased HIV (Human Immunodeficiency Virus) infection testing in Africa, many~     patients never enroll in subsequent HIV care after testing or remain in care after an initial~     enrollment. This study's aim is to improve linkage to HIV care and retention in HIV care~     through the use of feasible, evidence-based, and practical interventions. The study takes~     place in Swaziland, the country with the highest HIV prevalence (24%) in sub-Saharan Africa.~     The study will randomize groups of HIV testing sites and affiliated clinics to either~     standard of care or a combined intervention strategy (CIS) which consists of point-of care~     CD4 (cluster differentiation 4 (CD4)) testing at time of HIV testing, fast-track HIV~     medications for those who are eligible for treatment,mobile phone appointment reminders, care~     bags filled with health prevention materials, and financial incentives. The study outcomes~     are linkage to and retention in care as well as cost effectiveness, feasibility of~     interventions, and patient acceptability of interventions.~   "
127010|NCT01904981|"~     Various medical therapies have been proposed to prevent abdominal aortic aneurysm expansion.~     However, there have been very few randomized clinical trials to support use of any of these~     treatments. Several animal studies and observational reports suggest that ARBs can be useful~     in reducing abdominal aortic aneurysm (AAA) growth. However, so far, ARBs have not been~     evaluated in a randomized clinical trial. Therefore, the purpose of the study is to evaluate~     the effect of valsartan, an ARB, on annual growth rate in comparison with atenolol, a~     beta-blocker. Our hypothesis is that valsartan is superior to atenolol in the suppression of~     the aneurysm growth at 12 months. The BASE trial is designed as a investigator-initiated,~     multi-center, randomized controlled open-label trial. Patients with small AAA (aorta diameter~     <5cm) will be randomized 1:1 either to valsartan or to atenolol group. Randomization will be~     stratified by the AAA size (max. diameter >4 cm or ≤4 cm). Patients will receive either~     valsartan (daily dose 80 mg or more) or atenolol (daily dose 50 mg or more) for 12 months. A~     CT scan will measure the maximal diameter of AAA at baseline and 12 months. The annual growth~     of AAA will be compared between the valsartan and the atenolol group.~   "
127011|NCT01904968|"~     We conducted a preliminary study in 2010 using the innovative Illumina GoldenGate~     (methylation assay) which has enabled us to characterize the level of methylation of 807~     potential markers on a series of 200 adenocarcinomas of the colon (C18) and rectosigmoid~     junction (C19) resected between 1998 and 2001. The results, validated by pyrosequencing,~     allowed us to establish a panel of 12 markers to assess the level of methylation. The aim of~     this project is to validate the prognostic value of this panel in a second cohort of patients~     with adenocarcinomas (stage I to IV) resected between 2002 and 2006 in public and private~     hospitals (n=685).~      This study relies on an original collection of surgical specimens of colorectal cancers~     resected in public and private hospitals among patients resident in the département of~     Côte-d'Or and followed by the cancer registry of Burgundy. Samples obtained from each cancer~     and from adjacent normal mucosa are stored in liquid nitrogen in the Ferdinand Cabane~     Biological Resources Centre(certified S 96900). Annotations are collected by the cancer~     registry staff from multiple sources (pathologists, gastroenterologists, oncologists and~     radiotherapists).~      Pyrosequencing will be used to quantify the level of methylation. The percentage of~     methylated allele for each marker on cancerous DNA and the ratio of methylated markers to the~     number of markers analyzed will be determined. The molecular status of MSI, BRAF, KRAS, and~     PI3K will be taken into consideration.~      To study the prognosis, relative and relapse free-survival will be calculated. A multivariate~     relative survival analysis will be performed to determine independent prognostic factors~     taking into account the characteristics of patients and tumours and epigenetic and molecular~     alterations. Epigenetic alterations will be described according to age group, sex and~     subsite. The epigenetic phenotypes will be evaluated according to already known molecular~     status using logistic regression models.~   "
127012|NCT01904955|"~     The results of this study will make it possible, thanks to better understanding of the~     natural history of colorectal cancer, to define new treatment and surveillance strategies for~     colorectal cancers resected with curative intent, so as to improve management and thus~     improve patient survival.~      These data will also make it possible to calculate the prevalence of patients who require~     treatment or surveillance because of their disease.~   "
127673|NCT01896232|"~     The purpose of this study is to demonstrate that treatment with etelcalcetide (AMG 416) is~     not inferior to treatment with cinacalcet for lowering serum parathyroid hormone (PTH) levels~     by > 30% from baseline among patients with chronic kidney disease (CKD) and secondary~     hyperparathyroidism (SHPT) who require management with hemodialysis.~   "
127013|NCT01904942|"~     The project is based on a case-control study including cirrhotic patients with (200 cases)~     and without (400 controls) Hepatocellular carcinoma. The determination of sample sizes in~     proteomic or spectroscopic studies has to be adapted to the high dimensional setting. The~     proteomic analysis will be conducted by Clinical Innovation Proteomic Platform of Dijon. Two~     approaches will be used in the proteomic study: A global approach based on the comparison of~     proteomic spectra profiles obtained after mass spectrometry analysis (MALDI-TOF). The~     particularity of this study with regard to previous studies is : the procedures used to~     purify the sub proteomes (Five automated methods including depletion fractionation and~     purification will be applied), the qualification of the generated data with the introduction~     of quality controls, the high number of samples included in the study. The second approach~     BIA-MS (Biomolecular interaction analysis mass spectrometry) is targeted approach allows the~     capture, quantification and characterization of proteins.~      The quality controls allow to quantify the various variability sources and to validate that~     biological variability is higher than technical variability. All the samples will be treated~     and analyzed with the same protocols, 100 samples will be used to validate the marker and~     statistical models developed after analysis of the first 500 samples. The infra-red~     spectroscopy analysis will be conducted by MéDIAN team, CNRS UMR 6237 of Reims university.~     The first 300 samples after feature selection reference spectra, are classified into~     different classes by means of mathematical classification methods such as multivariate~     statistical processes of pattern recognition, neuronal networks, support vector machines and~     methods of case-based classification or machine learning, genetic algorithms or methods of~     evolutionary programming. The analysis of a second set of samples (300) will validate the~     different mathematical classification methods developed.~      In the global study the investigators will unravel the relationship between proteomic,~     spectroscopic and metabolic/nutritional data. The description of these relationships will use~     canonical analysis and multi-block analysis in a more general extent. The goal of these~     methods is to explore relationships that may exist between several groups of quantitative~     variables observed on the same set of individuals.~   "
127014|NCT01904929|"~     The objective of this project is to clarify and improve the efficiency of the standardized~     walk-test in Cardiovascular Rehabilitation. The psycho-metric properties of the 400m walk~     test at a self-selected speed will be evaluated. Such tests, made at a self-selected~     (comfortable, free) speed particularly assess the endurance capacities. The results of~     the physiological measurements during the tests will be compared with those of TM6min of Test~     of Fast Walking of 200m (TMR200m) and a maximal treadmill exercise. Stable coronary patients,~     aged over 55 years old, will be included.~      This study should permit a simplification and a better understanding of the clinical-use of~     walk tests. In the future, two kinds of tests might be proposed with different distances, 1-~     200m-fast-walking-test aimed to evaluate the performance closed to the maximum capacity, 2-~     self-selected-walk-test on a doubled distance (400m) aimed to evaluate the aerobic capacities~     of the adaptation of the body in response to effort.~   "
127015|NCT01904916|"~     Our knowledge on the genetic mutations in cancer is rapidly expanding and we are increasingly~     testing drugs in mainly metastatic cancer patient populations with rare mutations. Successful~     examples of this new strategy are ALK inhibitors in ALK translocated NSCLC (less than 5%~     frequency) and EGFR inhibitors in EGFR mutant NSCLC (approximately 5% frequency). Selecting~     molecularly stratified patient populations for studies benefits the patient as it increases~     the odds of obtaining benefit from experimental treatment, especially in early clinical~     trials. Moreover it increases the speed and efficacy of drug development as signs of efficacy~     are picked up in earlier phases. Therefore, broad screening of molecular lesions in the~     tumors of patients that are being considered for participation in trials is crucial. This~     pre-selection increases our ability to perform several trials in parallel and thus include~     more patients in more meaningful trials. With the still dismal prognosis of patients with~     metastatic cancer, increasing the accrual rate to pivotal trials in selected patient~     populations is a key factor in improving prognosis.~      The advent of Next Generation Sequencing (NGS) platforms enables us to probe a limited number~     of cancer related genes within 2-4 weeks. We have extensively piloted this approach and are~     now able to deliver clinically meaningful turn-around-times. This development enables us to~     use this technology to enrich clinical trials using targeted therapies for patients with~     specific mutations.~      We will obtain tumor biopsies of a metastatic or locally advanced lesion and a peripheral~     blood sample from all patients included in the trial; the biopsies to obtain information on~     the tumor related genetic mutations (mutational profile) and the blood samples to assess each~     patient's germline DNA background variation. As patients will be asked to undergo an invasive~     procedure it is important to address the potential safety issues. Review of the literature~     and our own experience show that tumor biopsies can be performed with only minor~     complications and acceptable risks. We will recruit patients with metastatic or locally~     advanced solid tumors from patients that can potentially be included in clinical trials.~   "
127016|NCT01904903|"~     HER2 positive breast cancer cells have more HER2 receptor (a protein on the surface of cells)~     than normal breast cells. Approximately 30% of patients with breast cancer have HER2 positive~     breast cancer. Before HER2 targeted therapies (i.e. treatments that directly block the~     receptor HER2) were developed, patients with HER2 positive breast cancer had a very~     aggressive form of disease. With the use of trastuzumab, an anticancer drug that directly~     targets the receptor HER2, and more recently, pertuzumab and ado-trastuzumab emtansine,~     patients are able to live longer and have better control of their cancer.~      Unfortunately the use of HER2 targeted therapies can increase the risk of heart problems and~     for this reason these treatments were only studied and approved for patients with normal~     heart function.~      In this study we plan to give HER2 targeted therapies to patients with HER2 positive breast~     cancer and mildly decreased heart function along with concomitant evaluation by a heart~     doctor (called cardiologist) and appropriate medications to strengthen the heart. We will do~     frequent monitoring of the heart function with a test called echocardiogram that will give us~     a detailed picture of the heart. We will also draw blood along with routine blood tests to~     try to understand why some patients develop heart problems and others do not. The study will~     take a maximum of 12 months and patients will be monitored for 6 additional months.~      We hypothesize that it is safe to administer HER2 targeted therapies to patients with breast~     cancer and mildly decreased heart function, i.e. LVEF between 40 and 50%, while on~     appropriate heart medications.~   "
127017|NCT01904890|"~     This is a behavioral research study to evaluate the effectiveness of a type of health~     education, lay health worker (LHWs), on increasing the use of a routine health behavior,~     colorectal cancer (CRC) screening, among Asian Americans, who underutilize such screening.~     Using quantitative and qualitative methods and a community-based participatory research~     (CBPR) approach, the project will develop and implement a group randomized controlled trial~     to evaluate LHW effectiveness in promoting CRC screening among Asian Americans age 50 to 75.~     The investigators will conduct focus groups and individual interviews with community~     participants to revise training and survey materials developed in prior projects. The~     investigators will recruit LHWs to be randomly assigned to the intervention arm and to the~     comparison arm. The LHWs will each recruit 15 participants from their social network.~     Intervention LHWs will be taught to teach their participants about CRC screening through 2~     outreach sessions and 2 telephone calls aimed at increasing their CRC screening receipt. LHWs~     and participants in the comparison group will receive a bilingual CRC brochure as well as 2~     lectures on healthy nutrition for cardiovascular health delivered by a health educator and an~     optional post- intervention LHW outreach session on CRC screening. Effectiveness of the~     intervention will be measured by pre-intervention and post-intervention surveys of community~     participants' CRC screening behaviors. The investigators will also conduct ethnographic~     observations of LHWs and their participants during the small group sessions and post-~     intervention focus groups to understand how such a health education approach may work.~   "
127019|NCT01904864|"~     This study is a randomized, controlled, double-blinded single center trial to compare the~     efficacy of NovaFerrum® to ferrous sulfate for the treatment of nutritional iron deficiency~     anemia (IDA) in infants and young children.~      Hypothesis: NovaFerrum® has greater efficacy than ferrous sulfate in increasing hemoglobin~     concentration during a twelve week course of treatment to subjects with iron deficiency~     anemia.~      Primary Aim:~      To compare the efficacy of NovaFerrum® to ferrous sulfate for the treatment of nutritional~     IDA in infants and young children as determined by increase in hemoglobin concentration.~      Secondary Aims:~        1. To compare the adverse effects of treatment for IDA between ferrous sulfate and~          NovaFerrum®~        2. To compare normalization of iron stores as demonstrated by laboratory measures of IDA~          (ferritin, TIBC, reticulocyte hemoglobin content) between subjects treated with ferrous~          sulfate or NovaFerrum®~        3. To compare the adherence to study medication between subjects on ferrous sulfate and~          NovaFerrum®~        4. To demonstrate efficacy of a once daily dosing regimen in the treatment of nutritional~          IDA~   "
127020|NCT01904851|"~     XLPAD is an observational study designed to evaluate the effectiveness and use of stent and~     non-stent based therapies among PAD patients. The study will create a registry that will~     include entry of procedural and clinical follow-up information into an online data collection~     software, REDCAP.Data available since Jan 1 2005 will be included in the registry, until~     14,000 patients have been included. The primary objectives of this observational registry~     study are to:~        1. Compare stent and non-stent based outcomes defined as a composite of symptom driven~          target vessel revascularization (TVR), unplanned surgical revascularization of the~          target limb and need for target limb amputation through 12 months post-index procedure~          (Primary efficacy endpoint)~        2. Compare stent and non-stent based outcomes defined as a composite of causes such as:~          death, myocardial infarction (MI), stroke, peri-procedural complications, target vessel~          revascularization (TVR) and unplanned surgical revascularization/amputation of the~          target limb through 12 months (Primary safety endpoint)~        3. Compare stent and non-stent based change in walking distance, Rutherford category and/or~          ankle- brachial index (ABI) at 12 months compared to baseline (Primary clinical~          improvement endpoint)~      Approximately 14,000patients will be enrolled at approximately 60 sites worldwide. Enrollment~     in the observational study will be monitored in an effort to achieve at least 20% (and no~     more than 80%) of the population receiving stents as the initial treatment strategy.~     Follow-up visits by sites will be reported at 6 and 12 months after index procedure to~     collect data on treatment patterns and effectiveness, and outcomes. The follow-up procedures~     are not mandated by the registry protocol. Each site will be encouraged to enter follow-up~     information derived from clinically indicated follow-up visits. All events post-index~     procedure till the 7th month will be reported under the 6 month follow-up form and subsequent~     follow-up till the 13th month post-procedure will be entered on the 12 month follow-up form.~      Patient management and treatment decisions are at the discretion of the care team per routine~     clinical practice. The procedural aspects (including selection of stent type or non-stent~     based treatments) and follow-up are not mandated by the registry and will be up to the~     discretion of the operator and/or based upon the practice dictated by the clinical care of~     the patient. Therefore the study poses minimal risk to the patient.~   "
127021|NCT01904838|"~     The overall objective of this study is to develop and test an efficient set of self-report~     instruments to measure Complementary and Alternative Medicine(CAM)-relevant contextual~     factors important in healing. The initial phase of the study involves developing and refining~     an item bank. During the initial 'item bank development' phase, the investigators will run~     focus groups and cognitive interviews with individuals who participate in CAM and~     conventional medicine interventions. The next step of instrument development is called~     Calibration, and involves administering the revised item bank to an internet sample and to~     persons who receive services in a CAM clinic and a conventional primary care setting. The~     items will be calibrated using item response theory and classical test theory. This will~     result in a computerized adaptive testing version of the instrument, as well as a static~     short form of the instrument. This current protocol in ClinicalTrials.gov pertains only to~     the Calibration Phase of the study. The final phase of the project will involve conducting~     initial validation studies of the set of instruments. The set of instruments will be called~     the Healing Encounters and Attitudes Lists (HEAL). The investigators will evaluate the~     convergent, discriminant, and predictive validity of the HEAL instruments in a sample of 200~     persons with chronic low back pain who are receiving physical therapy, chiropractic care, or~     mindfulness-based stress reduction. For convergent validity, the HEAL is expected to display~     moderate to large correlations with measures of similar constructs. The HEAL is expected to~     correlate modestly with self-report measures of general psychosocial functioning, in support~     of discriminant validity. Finally, HEAL scores should account for a significant proportion of~     the variance in treatment outcome, supporting predictive validity.~   "
127022|NCT01904825|"~     The aim is to set up tools that will serve as quality tracers for cryopreservation~     procedures.~      To meet this objective, we have chosen to develop reference samples (sentinel cells) that, in~     the medium term, can be used as controls to guarantee the quality of preservation for~     biological samples.~      The biological tools and an optimised follow-up strategy will make it possible to validate~     preservation procedures at the CRB in order to guarantee the perfect stability of samples and~     the validity of clinical studies.~   "
127023|NCT01904812|"~     Systemic lupus erythematosus is a complex disease whose evaluation in everyday practice and~     in clinical research requires several aspects to be taken into account, in particular the~     impact of disease activity on quality of life. To date, the effect of systemic lupus on~     quality of life has only been described using generic questionnaires. Among the specific~     questionnaires for systemic lupus, the LupusQol, which has been validated in French, shows~     interesting psychometric properties. The determinants of quality of life specifically related~     to the disease are still unknown and could be studied using a longitudinal cohort thanks to~     the French version of the LupusQol.~   "
127024|NCT01904799|"~     After a CVA, all of the cognitive functions can be affected and analysed, but the presence of~     a language disorder may considerably hamper the evaluation of other functions.~      The battery of rapid tests to screen for and quantify cognitive disorders, including the~     MMSE, the MOCA, the R-CAMCOG or the RBANS, are not suitable for aphasic patients because they~     contain items with a strictly verbal response. Because of this, inexperienced doctors cannot~     evaluate higher functions (other than language) of aphasics in routine practice. For the same~     reason, aphasics are regularly excluded from post-cva therapeutic protocols, whether or not~     the trial bears on the evolution of cognitive functions.~      Nonetheless, it is possible to evaluate, at least roughly, all of the cognitive functions~     without resorting to language.~      The investigator have developed , from validated tests and classical clinical manoeuvers, the~     Cognitive Assessment for Stroke Patients (CASP) :~        -  for the rapid screening (less than 15 minutes) and quantification of post-cva cognitive~          disorders (6 functions: language, apraxia, short-term memory, temporal orientation,~          impaired spatial/visio-construction and executive functions);~        -  the CASP can be used in most patients, including those with severe disorders of~          expression and moderate problems with comprehension, The format of these tests has been~          adapted so that severe disorders of expression (essentially left-hemisphere CVA), and~          left spatial impairment (right-hemisphere CVA) do not affect the ability to take the~          test. Its validity in terms of appearance and content were verified in 2011.~   "
127035|NCT01904656|"~     The purpose of this project is to implement and evaluate an intervention to increase and~     sustain rates of use of colorectal cancer (CRC) screening among men and women aged 50 and~     older in 6 intervention counties in Appalachia Ohio. Researchers will employ community-based~     participatory research (CBPR) in combination with two CRC interventions that have been~     developed and piloted with community partners to improve CRC screening~   "
127025|NCT01904786|"~     During the birth process certain conditions can cause oxygen delivery and/or blood flow to~     the baby's brain to become interrupted. This can cause permanent brain damage. Brain damage~     occurs in two phases. The first occurs at the time of injury when brain cells in the affected~     area 'die'. There is nothing that can be done about this. The second phase of injury occurs~     over the next few days. This second phase is caused by inflammation and release of toxic~     chemicals from the injured site. Cooling the baby to a temperature of 92.5° F, for 3 days has~     been shown to reduce the second phase of injury and bran death. All babies will receive the~     benefit of cooling. Although cooling helps it does not completely stop the second phase of~     injury.~      Melatonin is a naturally occurring hormone that is produced by the brain, and helps regulate~     the sleep-wake cycle. It has the potential to stop the second phase of brain injury by~     inhibiting inflammation and release of toxic chemicals. The reason for this research is to~     find out if melatonin can or cannot improve the outcome of babies with this kind of brain~     damage. Every baby enrolled in the study has a 50:50 chance of getting melatonin. A total of~     six doses of medicine will be given. The baby's brain function will be assessed by an EEG,~     brain oxygen monitoring, and a neurologic examination at 18 months of life. All of these are~     routinely used as part of standard care for patients with this kind of problem. The only~     difference is that half the babies enrolled in the study will get the drug called melatonin~     and the other half will receive placebo. The dose of melatonin being used in the study is~     higher than the amount normally produced by the body. No side-effects of this dose have been~     reported in other research studies using melatonin in newborn and premature babies.~   "
127026|NCT01904773|"~     This is a two-part, randomized, multi-center, blinded study in adolescents with Tourette's~     Disorder. There will be an up to 21-day screening period in which subject eligibility will be~     determined. In Part 1 of the study, the safety, tolerability and pharmacokinetics of AZD5213~     will be assessed during a 1- week period.~      In Part 2 of the study, the safety, tolerability, and preliminary efficacy of two doses~     (depending on tolerability in Part 1 of the study) of AZD5213 and placebo will be assessed~     through six consecutive four-week crossover periods. Each subject will receive both AZD5213~     and placebo. A follow-up vist will take place at 14 (±) 7 days following the last dose of~     study drug.~   "
127027|NCT01904760|"~     Reconstruction using microvascular free tissue flap has been an important management in~     patients with maxillofacial tumor. It is often characterised as long operation time, more~     traumatic and require restriction of patient's head movement postoperatively in order to~     prevent disruption of microvascular anastomosis. Agitation and delirium are common in~     patients with free flap surgery, which may lead to serious consequences such as self~     extubation, injury or even failure of the flap.~      Dexmedetomidine is a sedative and co-analgesic drug with high specificity for~     α2-adrenoceptor. It is widely used in ICU sedation in general hospital. However its use after~     free flap surgery is not well documented. Furthermore the effect of Dexmedetomidine on~     preventing delirium has not been proved.~      The investigators hypothesized that the use of Dexmedetomidine would reduce emergence~     agitation and prevent delirium in patients after free flap surgery.~   "
127028|NCT01904747|"~     This study is intended to quantify the effect of food on the extent of absorption of~     palbociclib.~      The caloric content of the food and the time of the meals with respect to palbociclib~     administration may influence the capacity of the body to absorb the drug.~      High and low calorie meals will be given to the subjects 30 minutes before palbociclib~     administration as 2 of the 3 conditions to compare with completely absence of food in the~     body when dosing (fasted).The third condition to test and compare with fasted stage will be~     the administration of food before and after palbociclib administration.~      This information will help the program to decide wether or not the presence of food when~     dosing palbociclib help with its absorption and to what extent it does help. Based on the~     collected information, a recommendation about the administration of palbociclib with food~     will be provided to patients.~   "
127029|NCT01904734|"~     This study aims to explore whether men with low testosterone levels, due to altered brain~     regulation of male hormone function, who have been previously treated with testosterone,~     respond as well as men who have not been so treated to clomiphene citrate, an agent commonly~     used for female infertility that has been shown to improve male hormone secretion in some~     cases.~   "
127030|NCT01904721|"~     This is a safety and efficacy study of bimatoprost in male subjects with androgenic alopecia~     (AGA).~   "
127031|NCT01904708|"~     Phenylketonuria (PKU), an inherited genetic disorder, can cause irreversible brain damage,~     declined executive function, and autistic tendencies unless a phenylalanine (Phe) restricted~     diet is consistently maintained throughout life. Promoting anabolism, the uptake of free~     amino acids from the extracellular space, is a key component to maintaining plasma~     phenylalanine concentrations within treatment range among patients with PKU. Exercise~     promotes muscle protein synthesis and anabolism, but the effect on blood phenylalanine~     concentrations in patients with PKU has not been reported.~      Our objective is to assess the impact of an acute bout of moderate intensity exercise on~     protein oxidation and plasma amino acid concentrations, as a potential adjunctive therapy for~     patients with PKU.~      The investigators hypothesize that moderate intensity exercise decreases amino acid~     oxidation, increases muscle protein synthesis, and promotes tissue uptake of essential amino~     acids, thereby lowering plasma phenylalanine concentrations in patients with Phenylketonuria.~   "
127032|NCT01904695|"~     The research of clinical effectiveness assessment is to explore the causal relationship~     between treatment and outcome.Accordingly, based on the effectiveness of tan-yu treatment,~     the research takes the Resistant Hypertension (RH) as example to study the causal inference~     methods under real world.~   "
127033|NCT01904682|"~     The study will enroll low risk MDS patients who need red blood cell transfusions and who are~     refractory to or are not using erythropoiesis-stimulating agents. The purpose of the study is~     to determine whether oral rigosertib treatment results in hematological improvements~     according to the 2006 International Working Group criteria in these patients. The study will~     also record any side effects that may occur during the study.~   "
127034|NCT01904669|"~     The purpose of this study is to assess the feasibility of conducting an Internet-based~     prospective pregnancy study with preconception enrollment with women completing daily~     journals for up to 12 months while trying to conceive and weekly through pregnancy if it~     occurs.~   "
127036|NCT01904643|"~     This phase I trial studies the side effects and the best dose of lenalidomide when given~     together with combination chemotherapy in treating patients with relapsed or refractory acute~     myeloid leukemia. Lenalidomide may stop the growth of acute myeloid leukemia by blocking~     blood flow to the cancer. Drugs used in chemotherapy, such as mitoxantrone hydrochloride,~     etoposide, and cytarabine, work in different ways to stop the growth of cancer cells, either~     by killing the cells or by stopping them from dividing. Giving lenalidomide and combination~     chemotherapy may be an effective treatment for acute myeloid leukemia.~   "
127037|NCT01904630|"~     The project will use exome sequencing to search for genetic predispositions for familial~     colorectal cancer (CRC). Except for certain syndromes there is today no good method for~     identifying individuals with a hereditary high risk for CRC (about 25% of the cases). There~     is currently no routine screening of the population in Norway for CRC today. Coloscopy, which~     is the most reliable method, is demanding with respect to resources, it can be painful, and~     may have complications. This project will attempt to find genetic determinants for~     identification of individuals with increased risk for familial CRC. Such methods will reduce~     unnecessary medical examination of unaffected family members, and will make it easier to~     focus health services on individuals with increased risk. This will represent a significant~     contribution towards improved health reduced death rate caused by CRC. The project includes~     research on the ethical aspects, in particular challenges related to how feedback to donors~     is handled.~   "
127038|NCT01904617|"~     This randomized controlled trial aims to compare three groups of intravenous fluids and their~     impact on labor: 1) 125 mL/hr of 5% dextrose in normal saline 2) 250 mL/hr of normal saline~     3) 250 mL/hr of 5% dextrose in normal saline~   "
127039|NCT01904604|"~     Food allergy occurs when the immune system reacts against foods. The immune system is the~     part of the body that protects us from illness and germs, but it can also cause allergies.~     Peanut allergy occurs in 1 - 2% of people in the United States and other Western countries.~     There is proof that allergy to peanut is increasing. Allergic reactions to peanut can be~     severe and life threatening. The only way that you can prevent an allergic reaction is to~     avoid exposure to peanuts. However, peanut proteins are found in a variety of foods and~     people can be accidently exposed to peanut proteins. Treatment for accidental exposure~     include antihistamines (medications like Benadryl), and injectable epinephrine (adrenalin)~     which must be carried at all times. DBV Technologies has developed an epicutaneous delivery~     system, a patch that puts the peanut protein on the skin.~   "
127040|NCT01904591|"~     This study will enroll 10 adults with a chronic spinal cord injury. The investigators will~     image their damaged motor tracts using MRI tractography scanning, and the investigators will~     formally assess their ASIA motor level at the outset of the study. Then, the investigators~     will treat them with one year of 'over the counter' dosage of selenium and vitamin E. These~     are two vitamins known to be anti-oxidants. After one year the investigators will repeat the~     MRI scans and ASIA assessments to determine if their has been any change in the appearance of~     motor tracts on MRI tractography, or in motor level on ASIA exam. As this is a pilot study~     the investigators are primarily concerned with establishing safety of this intervention, with~     a view to conducting a larger and more rigorous controlled trial in the future. The~     investigators also have a small hope that in fact some improvement might be found with~     vitamin treatment.~   "
127041|NCT01904578|"~     Sleep disorder is a common problem in menopausal women and the decrease in the sleep leads to~     poor daily activity. Traditional Chinese acupressure is a noninvasive, effective and safe~     technique that can be easily taught to menopausal women so that they apply it as a self-care~     method and a manager of sleep disruption. The purpose of the present study was to evaluate~     the effectiveness of acupressure on sleep quality of postmenopausal women.This double blind~     randomized clinical trial was performed on 120 qualified menopausal women at the age of 41-65~     years; and sleep quality was measured with Pittsburgh Sleep Quality Index (PSQI~     ).Participants were randomly assigned to an acupressure group, a sham acupressure group and a~     control group by two time randomized method (systematic and simple randomized). These~     interventions were carried out for 4 consecutive weeks. Participants in acupressure group and~     sham acupressure group learned to carry out acupressure technique as a self care at home with~     the simultaneous massage techniques that were to be performed 2 hours before sleep, whereas~     only conversation was used in the control group. The statistical software package for social~     science (SPSS) Version 17 was used for data analysis.~   "
127042|NCT01904565|"~     This is a multi-institutional phase I/II clinical trial with concomitant local hyperthermia~     and proton beam radiotherapy in patients with primary or recurrent unresectable soft tissue~     sarcomas of the extremities, trunk, retroperitoneum (except intrabdominal). The primary~     purpose would be to assess the safety and efficacy of this approach along with local tumour~     regressions and subsequent tumour downstaging, thereby enabling a near total removal of these~     tumours following the hyperthermia and proton beam therapy.~   "
127043|NCT01904552|"~     The aim of this in vivo study is to evaluate the influence of apical periodontitis (AP) on~     the accuracy of Dentaport ZX, Raypex 5, and i-Root electronic root canal length measurement~     devices.~   "
127044|NCT01904539|"~     This is a phase 1 study to evaluate the safety of a single 10 mg dose of obeticholic acid~     (OCA) in healthy volunteers and patients with liver disease.~   "
127045|NCT01904526|"~     Evaluate whether a 4mg/day or 6/mg day dose of extended-release guanfacine produces~     pharmacokinetic/dynamic (PK/PD) properties similar to 3mg/day immediate release guanfacine.~   "
127046|NCT01904513|"~     The primary objective of this pilot study is to determine if consumption of a probiotic~     yogurt causes reduced levels of environmental toxins in a group of school-aged Tanzanian~     children. The secondary objective is to determine the levels of environmental toxins in~     Tanzanian children and compare these to literature values of levels believed to negatively~     affect health and development. The third objective is to analyze the intestinal microbiota of~     the children and to determine if consumption of a probiotic yogurt has a significant affect~     on the microbiota composition.~   "
127317|NCT01900925|"~     There will be two groups of patients with low back pain (by randomization). Both groups will~     receive a pragmatic treatment approach by physical therapists for low back pain. One group~     will also receive a prescriptive treatment approach for both hips. The investigators feel~     that the additional of a standardized exercise program and stretching for the hips will~     improve outcomes in patients with mechanical low back pain.~   "
127047|NCT01904500|"~     Obesity has become an increasingly prevalent public health problem in the United States,~     reaching epidemic proportions. According to 2009 CDC epidemiologic data on obesity in the~     United States, 35.7% of the United States population is considered overweight or obese.~     Currently, on the review of the literature, over 20% of pregnancies in this country are~     complicated by maternal obesity. Obesity has been well demonstrated to be correlated with~     numerous adverse pregnancy outcomes such hypertensive disorders of pregnancy, gestational~     diabetes, and increased rates of operative delivery. Moreover, obesity, irrespective of~     pregnancy, has been demonstrated to be an independent risk factor for the development of~     postoperative surgical site infections. Development of such infections can have both~     consequential long-term medical sequelae for patients and economic impacts on the health care~     system at large. Cefazolin, a first generation hydrophilic cephalosporin whose clearance is~     exclusively mediated via the kidneys unchanged, is used as pre-operative antibiotic~     prophylaxis for cesarean deliveries. The current accepted standard of care is to administer 2~     grams of cefazolin within 60 minutes of skin incision. Studies of drug concentrations of~     cephalosporins for pre-operative antibiotic prophylaxis in obese bariatric patients have~     shown that therapeutic concentrations may not be achieved in both tissue and plasma. Limited~     data exist in pregnancy. Therefore, it is the goal of this study to investigate whether obese~     patients presenting for cesarean delivery require an increased dosing amount of pre-operative~     antibiotic prophylaxis. This study will randomized women with a pre-pregnancy body mass index~     of 30 kg/m2 or more who are presenting for their scheduled cesarean delivery to receive~     either 2 grams or 3 grams of cefazolin for pre-operative antibiotic prophylaxis. By drawing~     blood at specific time points in the peri-operative period and extracting adipose tissue~     samples during cesarean delivery, this study will investigate the pharmacokinetics of~     cefazolin in both the plasma and tissues of the obese gravida.~   "
127048|NCT01904487|"~     Background:~      - This study is being done to examine the role of a chemical GABA in the brain of alcohol~     dependent patients. GABA is the chief inhibitory neurotransmitter in the central nervous~     system. It helps induce relaxation and sleep and balances the brain by inhibiting~     over-excitation. Several studies have reported that anxiety disorders such as panic attacks,~     seizure disorders, and numerous other conditions including addiction, are all related to low~     GABA activity. Therefore, we will examine differences in GABA levels between healthy controls~     and subjects with alcohol addiction. Studies such as this are important to the understanding~     of the role of GABA in alcohol addiction.~   "
127049|NCT01904474|"~     This study aims to:~      I. Determine the e-therapeutic intervention program effectiveness compared with the standard~     treatment protocol, on both the behavioural change (treatment adherence and promotion of~     healthy lifestyles) and health impact (weight control and quality of life), based on a~     population of adolescents followed at Paediatric Obesity Clinic (POC) of Hospital de Santa~     Maria (HSM), Lisbon (Portugal).~      II. Evaluate the health profile, treatment adherence, lifestyle and impact of weight on~     quality of life of this population.~      III. Test the usability of an e-therapeutic platform for obese adolescents and their~     families.~   "
127050|NCT01904461|"~     The long-term objective of this study is to prove:~        -  the equivalence of the number of post-operation hemorrhages, and maybe a decrease of the~          number of secondary hemorrhages~        -  the decrease of pain and quicker re-feeding~        -  an easier haemostasis~        -  the simplification of the tonsillectomy surgical kit~        -  the decrease of dissection time~   "
127051|NCT01904448|"~     To purpose of this feasibility study is to demonstrate the safety and efficacy of the Nucleus~     24 Multichannel Auditory Brainstem Implant (ABI, Cochlear Corp, Sydney, AUS) in children~     without the diagnosis of neurofibromatosis type II (NFII) that have either experienced failed~     cochlear implantation (CI) or have been unable to receive a CI secondary to cochlear or~     cochlear nerve disorders. These conditions can include: developmental or acquired cochlear~     nerve deficiency (CND), cochlear aplasia (Michel), post-meningitic cochlear ossification or~     cochlear malformation.~      This study proposes to implant up to 10 young children (<5 yrs. of age) with the Nucleus 24~     Multichannel ABI (Sydney, AUS) in an attempt to demonstrate safety of the surgical procedure,~     tolerance of device stimulation, and the potential for auditory benefit beyond that~     experienced with their CI. This study will provide the preliminary experience for a larger~     scale clinical trial.~      Aim 1: Demonstrate the safety of ABI surgery in children. Aim 2: Demonstrate the development~     of sound awareness and improved speech understanding among children implanted with the ABI~     when compared to their baseline skills. Aim 3: Demonstrate the development of oral language~     skills following the use of the ABI that were not evident prior to its use.~   "
127052|NCT01904422|"~     Periodontitis is an infectious disease that destroys the tooth supporting tissues and~     triggers a local and systemic immune response. Type 2 Diabetes Mellitus (DM2) is a risk~     factor for periodontitis.Patients with DM2 and periodontitis have greater difficulty getting~     and maintaining an appropriate glycemic control. It has been reported an average decrease of~     0.4% in glycosylated hemoglobin levels (HbA1c) in patients periodontally treated versus~     untreated. It is not has been established that periodontal treatment type in spaced sessions~     (multiple sessions over a period of 4 weeks) or rapid and intensive (2 sessions in 24 hours),~     has a greater impact on glycemic control in type 2 diabetes patients.~      Objective: To evaluate the effectiveness of intensive periodontal treatment modality as~     compared with conventional on HbA1c level in periodontitis and DM2 decompensated patients.~   "
127053|NCT01904409|"~     The primary objective of this study is to assess the efficacy of rifaximin SSD versus placebo~     in preventing complications of liver cirrhosis, such as all-cause mortality (death due to all~     causes) or hospitalization, in subjects with early decompensated liver cirrhosis.~      Rifaximin, a non-systemic antibacterial agent, is currently marketed as a 550 mg tablet for~     the reduction in risk of recurrent overt hepatic encephalopathy, a complication of liver~     cirrhosis. The rifaximin SSD tablet was formulated to maximize the efficacy of rifaximin.~      Subjects will receive 1 of 5 doses of rifaximin SSD tablets or placebo tablets every day for~     24 weeks.~   "
127074|NCT01904123|"~     The goal of this clinical research study is to find the highest tolerable dose of WP1066 that~     can be given to patients with recurrent (has returned after treatment) cancerous brain tumors~     or melanoma that has spread to the brain. The safety of this drug will also be studied.~      WP1066 is designed to target the STAT3 pathway in cancer cells, which makes these cells~     divide, increases new blood vessels to the tumor, causes the cancer cells to move throughout~     the body and brain, and avoids them being detected by the immune system. Targeting this~     pathway may cause the immune system to kill the cancer cells.~      This is the first study using WP1066 in humans.~      This is an investigational study. WP1066 is not FDA approved or commercially available. It is~     currently being used for research purposes only.~      Up to 33 participants will be enrolled in this study. All will take part at MD Anderson.~   "
127075|NCT01904110|"~     The purpose of this study is to evaluate the Efficacy and the Safety of Monthly(RisenexM~     group) versus Weekly Oral risedronate(Risenexsplus group) in Korean postmenopausal~     osteoporotic women(Phase IV)~   "
127054|NCT01904396|"~     There are some adults with skeletal muscle weakness (called myopathy) and heart muscle~     weakness (called cardiomyopathy) who have low blood levels of a compound called carnitine~     as a cause of their problems. Carnitine is very important to energy production in muscles. In~     fact, there are reports of some people with carnitine deficiency who have developed myopathy~     and cardiomyopathy that was completely reversed with carnitine treatment. The main objective~     of our project is to determine the number of patients who have carnitine deficiency as a~     cause of their myopathy and cardiomyopathy. The investigators will be measuring carnitine~     levels in 1000 patients with cardiomyopathy and will describe the specific features in all~     the study patients to see if there are any trends that may help us predict which patients~     with muscle weakness are at risk of developing low carnitine levels. The investigators will~     be treating patients with low carnitine levels with carnitine and observing them to see if~     their cardiomyopathy and their muscle weakness improve. Knowing the exact percentage of~     myopathy and cardiomyopathy patients with carnitine deficiency may allow for screening of~     patients in a cheap and targeted way to treat the serious complication of this condition,~     including heart failure and sudden death.~   "
127055|NCT01904383|"~     Study to investigate the safety and efficacy of long-term daily use of Trazenta® Tablets as~     add-on therapy in patients with type 2 diabetes mellitus.~   "
127056|NCT01904357|"~     The primary objective of this study is:~      • To examine the pharmacokinetics (PK) of cefazolin in children aged 10 to 12 years~     (inclusive) receiving weight-dependent 1gram (g) or 2g of cefazolin intravenous (IV)~     delivered over 30 minutes via the DUPLEX® drug delivery system for surgical prophylaxis.~      The secondary objectives of this study are:~        -  To compare the PK data in children aged 10 to 12 years (inclusive)receiving 1g or 2g of~          cefazolin IV delivered over 30 minutes via the DUPLEX® drug delivery system with~          modeling data for adolescents aged 13-17 years (inclusive) and historical data from~          adults receiving a single 2g dose of cefazolin.~        -  To assess the safety of a single dose of cefazolin in children aged 10 to 12 years~          (inclusive) receiving 1g or 2g of cefazolin IV delivered over 30 minutes via the DUPLEX®~          drug delivery system for surgical prophylaxis.~   "
127057|NCT01904344|"~     The NXT_SLEEP study, bringing together industry partners, research groups and (home) care~     providers, tackles will develop a next generation sleep-monitoring platform that consists of~     less obtrusive sensors, and that delivers complete and useful information regarding the~     physiological parameters relevant for sleep-related breathing disorders.~      These new and innovative sensors need to be validated in a clinical setting where they will~     be benchmarked with the classical sleep monitoring systems. In order to compare the novel~     sensors with the classical monitoring system, the investigators use existing technologies~     that capture simultaneously the acquired signals of different physiological parameters~     relevant for sleep-related breathing disorders.~   "
127058|NCT01904331|"~     The purpose of this study is to assess the prevalence of cardiac dysfunction and~     (undiagnosed) heart failure in women registered in general practice with a history of breast~     cancer who received chemotherapy and / or radiotherapy as compared to a matched female~     control population.~   "
127059|NCT01904318|"~     A dose block-randomized, double-blinded, placebo-controlled, single dose, dose-escalation~     clinical phase I study to evaluate the safety, pharmacokinetics and food effect of IDP-73152~     mesylate after oral administration in healthy male volunteer~   "
127060|NCT01904305|"~     This study aims to determine whether interpretations of bronchoscopic results enable~     physicians to successfully predict the presence of pneumonia in traumatically injured~     patients.~   "
127061|NCT01904292|"~     This open-label, multicenter study will evaluate the pharmacokinetics, pharmacodynamics, and~     safety of subcutaneously administered tocilizumab in participants with Systemic Juvenile~     Idiopathic Arthritis (sJIA). Participants with body weight less than (<) 30 kilograms (kg)~     will receive subcutaneous (SC) tocilizumab dose every 2 weeks (Q2W) and participants with~     body weight greater than or equal to (>=) 30 kg will receive weekly (QW), for 52 weeks.~     Tocilizumab was administered every 10 days until pre-planned interim analysis was performed~     and changed to Q2W in participants with body weight <30 kg.~   "
127062|NCT01904279|"~     This open-label, multicenter study evaluated the pharmacokinetics, pharmacodynamics and~     safety of SC administered TCZ in participants with pJIA.~   "
127063|NCT01904266|"~     This research project intends to look at the effect that a certain type of freezing~     injection, called a paravertebral block, has on the pain after an operation for breast~     cancer, the amount of pain relief that is needed and the side effects from this pain relief.~     The hypothesis is that the paravertebral block, in combination with a general anesthetic will~     reduce both pain scores and the amount of strong pain killers (opioids) that is needed. This~     will reduce the side effects of the pain killers such as nausea and vomiting.~      This will be assessed by comparing it a general anesthetic with pain killers given through~     the intravenous (IV) as is routine practice. Patients requiring breast cancer surgery, who~     agree to be involved in the trial, will be randomly allocated into two groups: both groups~     will receive a block, then a standardised and optimised general anesthetic. In one group~     however the block is simply a small injection under the skin (a sham block), whereas the~     other group will receive a proper paravertebral block prior to this. Both groups will receive~     opioids as necessary, depending on both their bodies reaction during the surgery and their~     pain scores when they wake up.~      The paravertebral block is a very safe procedure with a very low side effect profile, and~     many studies have shown a benefit in breast cancer surgery. The investigators would like to~     assess this in our own practice. The block is normally inserted under some light sedation,~     with freezing into the skin initially. It is normally very well tolerated. The sham block~     will also be performed under light sedation and freezing into the skin. The patients will not~     be able to tell whether they are having the sham block or the paravertebral block, because~     both are very well tolerated. There are no potential complications from the sham block.~   "
127064|NCT01904253|"~     The purpose of this trial is to compare the effects of TAS-102 with either amrubicin or~     topotecan (drugs used in Small Cell Lung Cancer) on lung cancer to find out the effects on~     survival, how much time may pass without disease progression, and the safety of TAS-102.~   "
127076|NCT01904097|"~     The purpose of this study is to evaluate effectiveness and cerebral neuronal ability to~     adaptation in patients with fibromyalgia who receive pregabalin and transcranial direct~     current stimulation.~   "
127065|NCT01904240|"~     The cause of Parkinson's disease (PD) is currently unknown. Both environmental and genetic~     factors have been found to contribute to PD pathogenesis. The pathology of PD is distributed~     throughout the entire nervous system including the central, peripheral, and enteric nervous~     system. There is evidence that inflammation plays a major role in neurodegeneration in PD. In~     both the striatum and substantia nigra of PD patients activated microglia were found and~     proinflammatory cytokines (TNF, IL-1B, IL-6, iNOS) are increased in the CSF. An~     inflammation-driven animal model has emerged and has been widely accepted as a model of the~     disease based on lipopolysaccharide (LPS) induced neurotoxicity. LPS is an endotoxin found on~     the outer membrane of gram negative bacteria and humans are exposed to LPS through the~     intestinal tract. The intestinal tract and thus the enteric nervous system serve as a conduit~     to the central nervous system. It has been posited that the inflammatory process could gain~     access to the lower brainstem via the vagal nerve and then ascend through the basal mid- and~     forebrain until it reaches the cerebral cortex, producing various pre-motor and motor~     symptoms of PD along the way. LPS may be one of the inflammatory triggers involved in this~     process. Systemic exposure to bacterial endotoxin can be determined by measuring plasma LPS~     binding protein (LBP). A study of 9 patients with early PD (median Hoehn and Yahr stage 2)~     and age matched controls found that the PD subjects had a significantly lower mean level of~     plasma LBP compared to control subjects. The aim of the research plan is to establish LBP as~     a potential biomarker for PD across a spectrum of disease severity.~   "
127066|NCT01904227|"~     An randomized clinical trial to investigate whether among adult borderline patients (18 - 40~     year), intensified inpatient short term (12 weeks) inpatient Dialectical Behavior Therapy~     (DBT) is more effective in declining the proportion of patients that show~     suicidal/self-harming behavior in the first 3 months of treatment, compared to standard~     outpatient DBT, and whether this difference between the groups is sustained at 6 and 12~     months.~   "
127067|NCT01904214|"~     to quantify the effect of different degrees of renal impairment on the pharmacokinetics of~     BAF312 (and selected metabolites) and to assess safety and tolerability in order to develop~     dosing recommendations for subjects with renal impairment~   "
127068|NCT01904201|"~     The health of the immune system in HIV infected people is currently determined from a blood~     test measuring the number of cluster of differentiation 4 (CD4) T lymphocytes. These cells~     play a critical role in an immune response. Studies have shown that low numbers (below the~     normal range) of CD4 T lymphocytes indicates a defect in the immune system. Conversely, the~     number of CD4 T lymphocytes within the normal range generally indicates a normal immune~     system. When a person is infected with HIV the CD4 T lymphocytes are attacked and destroyed~     and the numbers decline meaning that the immune system can no longer effectively protect the~     body from infection or cancers. However, when the HIV infected person is successfully treated~     with Highly Active Antiretroviral Therapy (HAART) the CD4 T lymphocytes numbers increase and~     may end up in the normal range but the immune system may still not function properly as a~     number of these cells are incapable of functioning properly.~      It would be interesting to know how functional the immune system is rather than the number of~     cells. For this, the QuantiFERON® Monitor (QFM or CST007) test is an experimental diagnostic~     test used in this study to measure the immune function from people infected with HIV. The~     objective of this study is to evaluate the usefulness of the QFM test in HIV infected people~     compared with uninfected people by measuring the function of the immune system. The QFM test~     measures interferon-gamma released in the plasma following incubation of heparinised whole~     blood with a combination of stimulants. As immune function is directly influenced by cells~     with actively replicating HIV an additional research test called the HIV Reservoir Test will~     be included to better understand the level of immune function in each study subject.~      How long will it take? One visit for about 1 hour with Dr. Gatpolintan and his Clinical Study~     Coordinator to answer questions, then about 10 minutes for a blood draw (nine blocks from Dr.~     Gatpolintan' office).~      Study outcome measures (Correlation between QFM and CD4 counts and CD4/CD8 ratios) will be~     assessed, including data presentation, within an average period of 1 year after study subject~     enrollment.~   "
127069|NCT01904188|"~     The aim of this project is to test the utility of the Gene-Z device as well as other rapid~     identification techniques that we have developed in the lab on clinically obtained bodily~     fluid samples taken from patients with suspected sepsis based on having three of four~     positive Systemic Inflammatory Response Syndrome markers, or having a known infection for~     which a specimen is being collected. Specimens will be collected by Sparrow Laboratories and~     McLaren Greater Lansing laboratories, processed and stored for analysis at a later date to~     determine if the microbial pathogens identified by current methods of culture, as well as~     pathogen susceptibility to antibiotics by culture results, can be identified by the GeneZ~     technology or other developed technology accurately, and more timely. It will not affect~     current patient care nor impact patient care, which will continue in the standard fashion~     today for sepsis. Results will be compared to standard culture results and antibiotic~     sensitivities.~   "
127070|NCT01904175|"~     Allogeneic transplantation is used to treat many malignant and non-malignant diseases. The~     investigators and others have shown that less toxic preparative regimens (reduced intensity~     or 'mini' transplants) allow reliable allogeneic engraftment and durable remissions,~     significantly broadening the population of patients who may be offered this therapy to those~     who are older and more infirmed. The field is now focusing on the period post transplant for~     approaches to immune recovery leading to improved outcomes.~      The primary objective of this registry is to catalogue data from patients who undergo~     standard of care reduced intensity allogeneic transplantation.~   "
127071|NCT01904162|"~     Previous clinical studies have indicated that finafloxacin is well-tolerated with few~     treatment-related adverse events. As a part of the clinical development of finafloxacin,~     other PK studies are required to determine the effect of other variables on the PK profile of~     finafloxacin. This study aims to determine the effect of age and gender on the~     pharmacokinetic profile of finafloxacin.~   "
127072|NCT01904149|"~     This study aims to evaluate the analgesic efficacy of single and repeated doses of fixed~     combination of dexketoprofen trometamol (DKP) and tramadol hydrochloride (TRAM) in comparison~     to the single agents (and placebo for the single dose phase only).~      Approximately 600 female patients presenting moderate to severe pain after a total/subtotal~     abdominal hysterectomy are eligible to be randomised provided that they experience moderate~     to severe pain on the day after surgery.~   "
127073|NCT01904136|"~     The goal of this clinical research study is to learn about the safety of giving a kind of~     immune cells called natural killer (NK) cells with standard chemotherapy and an allogeneic~     stem cell transplant (using cells from a donor). Researchers also want to learn the highest~     tolerable dose of NK cells that can be given.~      Immune system cells (such as NK cells) are made by the body to attack foreign or cancerous~     cells. Researchers believe that the NK cells you receive from the donor may react against the~     leukemia cells in your body, help eliminate leukemia, and prevent disease relapse.~   "
127078|NCT01904071|"~     Hip Fracture (HFx) is a painful injury that is often treated in the Emergency Department (ED)~     with intravenous opiates. However, this class of medications may cause deleterious side~     effects. An alternative analgesic approach involves regional anesthesia. The investigators~     attempted to determine (1) whether ultrasound guided peripheral nerve blocks (UPNBs) could be~     safely performed in an ED setting, (2) whether UPNBs would be more effective than standard~     treatment in controlling pain from HFx and (3) which of two UPNBs was superior for pain~     relief.~      A convenience sample of patients with an isolated HFx and a pain score > 5/10 were enrolled~     and randomized to one of three arms: (1) Ultrasound guided 3-in-1 femoral nerve block (UFNB),~     (2) Ultrasound guided fascia iliaca compartment block (UFIB), or (3) IVMS. Patients indicated~     their pain from 0 (no pain) to 10 (extreme pain).~   "
127079|NCT01904058|"~     The study is a randomized, double-blind, placebo-controlled, multicenter study. It is a~     13-week Phase 2 study in adults with primary biliary cirrhosis designed to compare the effect~     of daily dosing with UDCA in combination with LUM001 or placebo.~   "
127080|NCT01904045|"~     Aim of this study is to investigate whether in patients following kidney transplantation (>6~     months after transplantation), the intra-patient variability of levels of tacrolimus is~     comparable after administration of tacrolimus twice daily (Prograf) to tacrolimus once daily~     (Advagraf), with each regimen for 3 months.~   "
127081|NCT01904032|"~     This is a randomized clinical trial (RCT) to determine the effectiveness of vitamin D3~     supplementation on depressive symptoms, self-management, and blood pressure in approximately~     180 adult women with type 2 diabetes who have significant depressive symptoms. Consenting~     adult women who are eligible to participate will be randomly assigned to either a weekly dose~     of 50,000 international units of vitamin D3 supplementation or a matching weekly active~     comparator of 5,000 international units of vitamin D3 for six months. Participants will~     complete approximately four in-person study visits and several telephone visits throughout~     the six month trial period, where the researchers will assess depressive symptoms, diabetes~     self-management, and systolic blood pressure.~   "
127082|NCT01904019|"~     Comparison of functional outcome at 3 years after trapezio-metacarpal arthroplasty with~     trapeziectomy and trapeziectomy with ligament reconstruction and tendon interposition.~   "
127083|NCT01904006|"~     Previous studies in human and different mammals have proved that the embryo group culture (in~     the same culture medium drop) using a reduced volume is associated with a better embryo~     development. This is due to the effect of different autocrine and paracrine factors secreted~     by the embryos. Besides, previous studies with embryos from human and other mammals have~     shown that a high oxygen concentration may have a negative effect on embryo quality due to~     the generation of reactive oxygen species, which cause oxidative stress. The embryo culture~     at low oxygen tension is correlated to better success rates in IVF/ICSI treatments.~      The purpose of this study is to evaluate the combined effect of the embryo group culture and~     the low oxygen tension on the embryo development and the results of the IVF/ICSI treatments.~     The specific goal is to compare the embryo group culture in a reduced volume of medium at a~     low oxygen tension (5%) with the standard individual culture at an atmospheric oxygen tension~     (20%). The first culture condition will be applied in a K-MINC incubator (COOK Medical®),~     whereas the second condition will be applied using a Heracell incubator (Heraeus®).~   "
127084|NCT01903993|"~     This multicenter, open-label, randomized study will evaluate the efficacy and safety of~     Atezolizumab compared with docetaxel in participants with advanced or metastatic non-small~     cell lung cancer after platinum failure. Participants will be randomized to receive either~     Atezolizumab 1200 milligram (mg) intravenously every 3 weeks or docetaxel 75 milligram per~     meter square (mg/m^2) intravenously every 3 weeks. Treatment with Atezolizumab may be~     continued as long as participants are experiencing clinical benefit as assessed by the~     investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration~     attributed to disease progression.~   "
127085|NCT01903980|"~     Epipericardial fat necrosis is a benign and self-limited condition that mainly curses with~     acute pleuritic chest pain and therefore must be an important differential diagnosis for~     patients in emergency department (ED). The knowledge of characteristics symptoms and correct~     management may avoid misdiagnosis or mistakes with other severe conditions like pulmonary~     embolism, pericarditis or acute coronary disease.~      Despite the importance of this entity, only fewer than 40 cases have been reported since~     1957, when the condition was first described.~      We have seen a couple of similar cases in our institution during a short period of time, and~     we suspect that these numbers doesn`t mean the real prevalence of epipericardial fat~     necrosis, so maybe this condition could be underdiagnosed. Instead, there isn't a study that~     tried to estimate an incidence of this entity.~   "
127086|NCT01903967|"~     Recent studies estimate that the prevalence of pituitary adenomas is approximately 1/1500~     persons. Pituitary tumours are usually considered as benign. However, local invasion is~     reported in 35-40% of pituitary adenomas; resistance to medical treatment or recurrence~     leading to multimodal therapy is reported in about 15% of cases. These tumours are considered~     as aggressive pituitary tumours and present a distinct biological and clinical entity with~     continued growth despite multimodal therapy, including surgery and radiotherapy (McCormack et~     al., 2011). Whilst these tumours have malignant potential, the term of pituitary carcinoma is~     strictly reserved for those rare tumours (0.2%) with demonstrated craniospinal or systemic~     metastases (Heaney, 2011).~      Pituitary aggressive and malignant tumours are very difficult to control and ultimately prove~     to be lethal. It was suggested that early aggressive treatments (chemotherapy, radiotherapy)~     may control progression and occurrence of metastases. However, these therapeutic options are~     associated with important side effects limiting their use and the prediction of pituitary~     tumor behaviour remains a challenge. At the diagnosis, clinical signs are not specific and~     the results concerning proliferative factors (Ki-67 and P53), putative oncogenes (PTTG)~     conflict from one series to another.~      In a case-control retrospective study of a cohort of 410 patients (HYPOPRONOS), we validated~     a prognostic pathological classification based on histological and radiological data (J.~     Trouillas 2012 in preparation). Tumours were classified into 3 grades: grade 1= non-invasive~     tumour, grade 2= invasive tumour and grade 3 = aggressive-invasive tumor with the combination~     of radiological signs of invasion and 2 of 3 signs of increased proliferation (Ki-67~     index>3%, number of mitoses>2 per 10 fields at 400X, P53 nuclear detection).~      It is now widely accepted that cancer is a clonal disease, which arises from a single normal~     cell and progresses thanks to the accumulation of DNA alterations (Sanson et al., 2011). To~     identify the role of these DNA alterations, we conducted array CGH analysis limited to 13~     prolactin pituitary tumours, from frozen fragments, and identified allelic loss of chromosome~     11 associated with aggressiveness and malignancy (Wierinckx et al., 2011).~      To confirm these encouraging results we propose to conduct a study on a large series of~     tumours, fixed and embed, and to be correlated the results to clinical data.~   "
127383|NCT01900054|"~     The objective of this study is to evaluate the long-term safety and efficacy of TAU-284~     (Bepotastine besilate) in pediatric patients with perennial allergic rhinitis for 12 weeks~     administration.~   "
127087|NCT01903954|"~     This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety~     of setrobuvir in patients with genotype 1 chronic hepatitis C. Treatment-naïve patients will~     be randomized to receive either setrobuvir (800 mg orally b.i.d loading dose followed by 200~     mg orally .b.i.d.) or placebo in combination with standard of care Pegasys (peginterferon~     alfa-2a) and Copegus (ribavirin). Treatment duration will be 28 weeks or 48 weeks depending~     on response. Treatment-experienced patients categorized as relapsers, partial responders and~     viral breakthrough patients to previous pegylated interferon and ribavirin therapy will be~     randomized to receive either setrobuvir or placebo in combination with Pegasys and Copegus~     for 48 weeks. Treatment-experienced patients categorized as null-responders to previous~     pegylated interferon and ribavirin therapy will be assigned to treatment with setrobuvir plus~     Pegasys and Copegus for 48 weeks.~   "
127088|NCT01903941|"~     Aerobic physical activity attenuates systemic inflammatory activity in individuals with~     cardiovascular risk.~   "
127089|NCT01903928|"~     This study is to evaluate safety and tolerability of a therapeutic vaccine, ASP0113, in~     subjects undergoing allogeneic HCT. The occurrence of CMV viremia and immunogenicity are also~     assessed.~   "
127090|NCT01903915|"~     There were a few studies about the relationship of structural or functional abnormalities of~     brain and social cognitive dysfunctions in patients with schizophrenia. In addition, default~     network, which increases activity during mental explorations referenced to oneself including~     remembering, considering hypothetical social interactions, and thinking about one's own~     future, may be associated with social cognitive dysfunctions in patients with schizophrenia.~     Therefore, we will investigate the dysfunction of default network in patients with~     schizophrenia compared with healthy controls and the effect of default network dysfunctions~     on the social cognition in patients with schizophrenia.~   "
127091|NCT01903902|"~     The purpose of this study is to evaluate the efficacy and safety of paclitaxel-eluting~     balloon (SeQuent® Please) for treatment of lesions in native small coronary arteries.~   "
127092|NCT01903889|"~     The study employs a quasi-experimental design in 8 public health centers in southwest Uganda~     offering care and treatment (C&T) services. In 4 health centers, a basic intervention is~     introduced, whereby HIV/AIDS providers are trained on contraception for HIV-positive women.~     They are charged with counseling C&T clients on FP; offering condoms, pills and injectables;~     and referring clients for other FP methods. In the other 4 health centers, the basic~     intervention is introduced along with an intervention for constructive male engagement in HIV~     and FP services. This includes training of C&T providers on gender-based influences on health~     behaviors; provision of couples' HIV testing and FP counseling services; and community-based~     education for men to promote gender equitable norms and male participation in health~     services.~   "
127093|NCT01903876|"~     This is a study to determine whether a theoretically-driven web-based 3-hour intervention~     designed for male college students called RealConsent is effective in increasing prosocial~     intervening behaviors and in preventing sexual violence perpetration. Sexual violence~     programs for this population have been implemented for decades in the United States, but a~     program that is web-based and incorporates the bystander education model has never been~     implemented or tested. In this study, male college students will be recruited online,~     enrolled and randomly assigned to RealConsent or to a comparison condition. Prior to the~     intervention, investigators will ask questions about their intervening and sexually coercive~     behaviors and other theoretical and empirical factors related to the study outcomes.~     Investigators will survey the young men again at post-intervention, and at 6-months follow-up~     to determine whether young men in the RealConsent program intervened more often and engaged~     in less sexual violence compared to young men in the comparison condition. The main~     hypotheses are: (1) college men in the RealConsent program will report more instances of~     prosocial intervening; and (2) college men in the RealConsent program will report less sexual~     violence against women.~   "
127094|NCT01903863|"~     The purpose of this study is to assess the impact of scheduled fresh frozen plasma (FFP)~     administration on extracorporeal membrane oxygenation (ECMO) pump longevity in critically ill~     pediatric and neonatal patients. Almost all ECMO patients receive multiple FFP transfusions~     during their ECMO course. The investigator proposes that scheduled FFP may maintain pro and~     anticoagulation balance thus mitigating the need for expensive and dangerous ECMO pump~     changes. In addition, this may lead to less overall transfusion with all products (red blood~     cells, platelets, and FFP) if coagulation homeostasis is maintained. The subjects will be~     neonatal and pediatric patients requiring ECMO support for any reason in the pediatric and~     pediatric cardiac critical care units. Subjects will be randomized to receive every other day~     FFP infusions or FFP administration per current standard of care. ECMO pump longevity (hours)~     and FFP use will be compared between the two groups There is a small risk that study subjects~     may receive more FFP transfusions and therefore have the increased associated risks however~     it is also possible that these subjects may benefit from less ECMO circuit changes and/or~     fewer transfusions of all blood products.~   "
127095|NCT01903850|"~     The purpose of this study is to prospectively assess the efficacy and safety of spray~     cryotherapy ablation with the truFreeze System in conjunction with mechanical dilation or~     debridement for the treatment of clinically significant obstructions of the central airways.~     The primary effectiveness endpoint is the proportion of subjects with a minimum of 25%~     improvement in luminal patency following SCT treatment and mechanical intervention 30 days~     (+/- 5 days) following treatment. Additionally, a primary clinical safety endpoint is the~     reporting of all adverse events.~   "
127096|NCT01903837|"~     This is a Phase 2, randomized, placebo-controlled multicenter study, which will be conducted~     in 2 parts. The study duration for each subject will be approximately 33 weeks and will~     include 25 study visits.~   "
127097|NCT01903824|"~     This is a single center, double-blind, placebo and positive-controlled, randomized, partial~     6-way cross-over study to investigate the pharmacodynamics and pharmacokinetics of CEP-26401~     (5, 25, and 125 μg) following single-dose administration to healthy male and female subjects.~   "
127448|NCT01899209|"~     Obstructed Defecation is a profoundly disabling condition. Many different surgical procedures~     has been introduced to treat patients affected by this disease. The most used are STARR and~     ventral rectopexy. Because of the heterogenity of studies and overall the lack of comparison~     trials, there is no accepted standard surgical treatment.PRO-REST aimed to compare these two~     procedures (STARR and Ventral Rectopexy) evaluating functional and anatomical results.~   "
127098|NCT01903811|"~     This randomized phase II trial compares how well two different doses of carfilzomib work when~     given with dexamethasone in treating patients with multiple myeloma that has come back after~     a period of improvement or has not responded to treatment. Carfilzomib may stop the growth of~     cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Giving carfilzomib together with dexamethasone may kill more cancer cells. It is~     not yet known whether a higher or lower dose of carfilzomib works better when given with~     dexamethasone.~   "
127099|NCT01903798|"~     This clinical trial will test two new therapies for the treatment of alcoholic hepatitis.~     Patients who respond to the current standard of care therapy for alcoholic~     hepatitis(corticosteroid/prednisolone therapy) after 1 week of treatment will be randomly~     assigned to either continue on standard therapy, or, to begin treatment with rilonacept in~     combination with standard therapy. Patients who are non-responders to the current standard~     of care therapy after 1 week of treatment will be randomly assigned to standard of care or to~     begin treatment with mycophenolate mofetil in combination with standard therapy. Patients~     will be treated for a total of 4 weeks in this clinical trial. Patients will be followed for~     up to five months after completing therapy (6 months total).~   "
127100|NCT01903785|"~     Athletes using asthma medications called β2-agonists win a disproportionately high number of~     medals at Olympic Games. Due to a large variety in the genes that affect how individuals~     respond to β2-agonists, the investigators will look at variations in the genetic response to~     these medications by dividing athletes into high-responders and low-responders. The~     investigators will then compare athletic performance after the inhalation of β2-agonists to~     placebo. Furthermore, the investigators will analyze the effect of β2-agonists on breathing~     mechanics. Due to differences in their anatomy females may decrease the energy needed for~     breathing during high-intensity exercise to a greater extent compared to male athletes after~     the inhalation of β2-agonists.~   "
127101|NCT01903772|"~     The additional effect of inspiratory muscle training as an adjunct to a general exercise~     training program in patients with COPD with inspiratory muscle weakness will be studied. The~     main hypothesis is that inspiratory muscle training combined with an exercise training~     program improves functional exercise capacity more than an exercise training program without~     the addition of an inspiratory muscle training program.~   "
127102|NCT01903759|"~     The principal aim of this study is to help obstetricians to diagnose chorioamniotic infection~     early, in cases of premature rupture of the fetal membranes before 34 WA, by proposing~     earlier and more specific markers of infection than FBC and CRP. The aim is to reduce vital~     and functional risk of acute chorioamnionitis for the mother, the fetus or the newborn,.~      If the kinetics profile of one or several markers correlates strongly with the diagnosis of~     chorioamnionitis, it could be used in clinical practice, possibly in the context of another~     clinical study.~      The results of the study presented here are destined to be published in obstetrics journals.~   "
127103|NCT01903746|"~     The epidemiology of this study aims and outcome of patients with septic shock in the~     intensive care unit (or versatile) of the North-East region in france as well as the~     modalities of care.~   "
127104|NCT01903733|"~     The objective of the study is to provide long term access to bosutinib treatment and assess~     long term safety, tolerability and duration of clinical benefit, without any formal~     hypothesis testing; therefore, there is no formal primary endpoint.~   "
127105|NCT01903720|"~     This study will evaluate the safety and efficacy of OZURDEX® (700 µg dexamethasone implant)~     in patients with macular edema associated with branch retinal vein occlusion.~   "
127106|NCT01903707|"~     The aim of this project is to undertake a randomized placebo controlled trial of cognitive~     remediation therapy (CRT) that focuses on working memory training in a sample of community~     based patients with chronic schizophrenia or other psychoses.~      Cognitive deficits are a problem for many people with schizophrenia. This study will use~     computerized cognitive remediation training (which the participant can carry out at home)~     over a period of a few months.~   "
127107|NCT01903694|"~     Principal objective: to evaluate the effect of the combination pravastatin - sorafenib versus~     sorafenib alone on overall survival in patients with hepatocellular carcinoma developing on~     Child-Pugh A cirrhosis who are unsuitable for curative treatment.~      Secondary objectives: evaluate the effect of this treatment on progression-free survival, the~     time to progression, the time to treatment failure and quality of life (QLQ-C30 et FACT HEP)~   "
127108|NCT01903681|"~     There is increasing evidence that chronic sleep disorders in children with autism spectrum~     disorder (ASD), Angelman Syndrome (AS) and Smith-Magenis syndrome (SMS) are associated with~     disturbed melatonin secretion and melatonin administration has been shown to be effective in~     these populations. For children who have difficulties swallowing a tablet, Neurim has~     developed an age-appropriate Melatonin formulation in the form of mini-tablets which have the~     same dissolution profile as the Circadin® tablets product, thus should produce the same~     melatonin concentration-time profile with the same effects. This study concerns the~     pharmacokinetic study.~      The purpose of this study is to :~        -  Establish the 24 hour baseline profile of endogenous saliva melatonin concentrations and~          urine 6-SMT excretion in children aged 2 up to and including 17 years with~          neurodevelopmental disorders with sleep disturbances.~        -  Establish the concentration-time profile of saliva melatonin concentrations and 24 hour~          6-SMT urine excretion after 2 and 10 mg Circadin® mini-tablets single dose~          administration in children aged 2 up to and including 17 years with neurodevelopmental~          disorders with sleep disturbances.~        -  Evaluate the adverse event profile after a single dose of 2 or 10 mg Circadin®~          mini-tablets in children aged 2 up to and including 17 years with neurodevelopmental~          disorders with sleep disturbances.~   "
127109|NCT01903668|"~     Step 1: Identification and characterisation of the TREM1L protein from samples already~     available characterised at the hospital Central of Nancy Step 2: Study of the isoforms of~     TREM1L in correlation with the prognosis of sepsis, Step 3: implementation of assay methods~     for TREM1L (ELISA or SUPRA MS) Step 4: Validation of assays for TREM1L and its isoforms in a~     larger number of subjects (inclusion of samples from Dijon CHU and Besançon CHU)~   "
127449|NCT01899196|"~     Protocol date and version RCB Id : 2013-A00547-38~      Etude ANRS EP 52 PIECVIH Title of Study: EPICARDIAL ADIPOSE TISSUE AND CORONARY RISK IN~     HIV-INFECTED PATIENTS~      Short title - PIECVIH study~      Sponsor French National Institute for Health and Medical Research - French national agency~     for research on AIDS and viral hepatitis (Inserm-ANRS)~      Coordinating Investigator Pr Franck BOCCARA Service de Cardiologie, Hôpital St Antoine INSERM~     UMRS 938 Paris, UPMC, Institut hospitalo-Universitaire- Institute of Cardiometabolism and~     Nutrition (IHU-ICAN) 184, rue du Faubourg Saint-Antoine 75571 PARIS Cedex 12 Tél. : 01 49 28~     24 49 - Fax : 01 49 28 26 83 Courriel : franck.boccara@sat.aphp.fr~      Participating country: France~      Objectives Principal objective To compare the inflammatory profile of the epicardial adipose~     tissue (EAT) between people living with and without HIVwho present with coronary heart~     disease and will undergo a coronary artery bypass graft (CABG)~      Secondary objectives~        -  To compare the volume of EAT between people living with and without HIV who present with~          coronary heart disease~        -  To evaluate the relationship between the abnormalities of the expression profiles of the~          adipocytokines and cytokines with the atherosclerotic lesions.~        -  To evaluate the relationship between the abnormalities of the expression profiles of the~          adipocytokines and cytokines of the EAT with the circulating levels and metabolic~          parameters.~        -  To compare the histological and inflammatory profiles of the EAT with the subcutaneous~          adipose tissue for each patient individually.~      Methodology multicentric, comparative study~      Estimated enrollment 31 participants in total~        1. st group of- 15 people living with HIV undergoing CABG (coronary heart disease HIV+~          group)~        2. nd group of- 16 people without HIV- undergoing CABG (coronary heart disease HIV- group)~          People without HIV-will be matched to people living with HIV+ by : age (± 5 years) and~          sex Outcomes~      Primary outcome:~      Comparative analysis of the inflammatory profile of the EAT : expression profile of the pro~     and anti inflammatory cytokines and adipokines within the EAT in both groups of participants~     : coronary heart disease HIV+ and HIV- groups~      Secondary outcomes :~        -  Determination of the EAT volume by echocardiography and cardiac scanner for both groups~        -  Macroscopic profile of the EAT : adipocytes, fibrosis, endothelial cell density)~        -  RT-PCR analyses : renin, adiponectine, PPARɣ~        -  Comparatison of the inflammatory and macroscopic profiles between the EAT and the~          subcutaneous adipose tissue in the two groups by ARN messagers analysis.~      Eligibility Inclusion criteria HIV+ group~        -  Men or women above the age of 18 years old, HIV1 seropositive for more than 6 months~        -  Individual undergoing, for the first time, cardiac surgery for CABG~        -  Affiliated with a social security regimen (the AME is not a social security regimen)~        -  Signed the consent form~      HIV- group~        -  Men or women above the age of 18 years old, HIV seronegative~        -  Individuals undergoing, for the first time, cardiac surgery for CABG~        -  Affiliated with a social security regimen (the AME is not a social security regimen)~        -  Signed the consent form~      Non-inclusion criteria History of surgery for CBAG and/or congenital heart defect- being~     under the tutorship or guardianship of the state or in custody of the justice system.~      Statistical methods Categorical variables will be compared using Fisher's exact test.~     Continuous variables will be compared using the Student's t-test (parametric) and the~     Wilcoxon-Mann-Whitney test (non-parametric) as appropriate considering the data distribution.~     (statistical analysis software STATA 11 (StataCorp, Texas, USA))~      Provisional study planning and timetable Study start date: July 2013 Enrollment period: 32~     months Subject participation duration: 24 hours Total study duration: 32 months Estimated~     study completion date: end of March 2016~   "
127110|NCT01903655|"~     The mechanisms of oxidative stress and inflammation involved in mood disorders are factors of~     chronicity and severity. These mechanisms induce a phenomenon of accelerated cellular~     senescence and are reflected by alterations in systemic gene expression detectable in~     leukocytes in peripheral blood. The genetic markers of these mechanisms are clinically~     significant markers. The identification of new genetic markers will make it possible to~     improve evaluations of the severity and somatic consequences of depressive syndromes.~   "
127111|NCT01903642|"~     The hypotheses of our research are based on the fact that various pathological states,~     infection, cancer, inflammatory disease, can induce an inflammatory syndrome, through~     different pathways, even though the clinical presentation can be identical. The~     identification of biological markers specific to an etiology would therefore allow a faster~     diagnosis and improve care for patients. We thus took an interest in the three groups of~     diseases most frequently responsible for an inflammatory syndrome, infections, cancers and~     auto-immune diseases. To achieve this, various methods will be used.~   "
127112|NCT01903629|"~     Passive video capsule endoscopy is the criterion standard for small-bowel diseases but cannot~     be used for the large gastric cavity.This blinded prospective study investigates the accuracy~     of the magnetic-controlled capsule endoscopy compared to gastroscopy in patients with gastric~     symptoms and indication for upper GI Endoscopy.~   "
127113|NCT01903616|"~     This study investigates the longitudinal course of developmental patterns in movement and~     participation in life activities (MPLA) of young children with cerebral palsy (CP) in Taiwan.~     Additionally, the predictors in the initial stage in determining the final developmental~     patterns in movement and participation in life activities MPLA of these children will be~     identified.~   "
127114|NCT01903603|"~     The primary goal of this study is to establish and evaluate an image-based biomarker for the~     impaired motor control and sensory information processing present in Cerebral palsy (CP)~     patients~   "
127115|NCT01903590|"~     The aim of this study is to compare trans-vaginal tape(TVT) and trans-obturator tape(TOT)~     procedure in female urinary stress incontinence with no intrinsic sphincter deficiency.~   "
127116|NCT01903577|"~     Robotic surgery holds the potential to overcome many of the ergonomic challenges posed by~     laparoscopic surgery. In this study, we propose to quantify this potential ergonomic benefit~     by measuring electromyography (EMG) and instrument motion analysis of subjects performing~     surgical tasks using robotic assistance versus standard laparoscopic instrumentation.~      Hypothesis: We hypothesize that surgeons will experience significant, measurable ergonomic~     advantages when performing tasks using robotic surgery when compared to conventional~     laparoscopic tools.~      Study design: Subjects for the study will include three groups of varying degrees of training~     - (1) novice laparoscopists/novice roboticists, (2) expert laparoscopists/novice roboticists,~     and (3) expert laparoscopsts/expert roboticists. Subjects will perform the following tasks~     (chosen based on their reliability and validity in previous studies). Each task will be~     performed with standard laparoscopic instrumentation and with the da Vinci Surgical System.~        -  Inanimate (dry lab): Fundamentals of Laparoscopic (FLS) peg transfer, pattern cutting,~          intracorporeal suturing.~        -  Animate (porcine lab): laparoscopic bowel resection and anastomosis, robotic bowel~          resection and anastomosis.~        -  Human (clinical case): any laparoscopic or robotic procedure (preferably laparoscopic~          bowel resection and anastomosis, robotic bowel resection and anastomosis).~      Outcome measures:~        -  Time to completion of tasks~        -  EMG: peak amplitudes, % maximum voluntary contraction and frequency analysis~        -  NASA Task Load Index scores~        -  Subject-Reported Qualitative Data from surveys~        -  Quality analysis of tasks (e.g., pattern cutting accuracy, % knots tied securely) for~          dry lab and animate lab tasks only)~        -  Instrument motion analysis of tasks (for dry lab and animate lab tasks only)~   "
127117|NCT01903564|"~     Fetal research and clinical practice has been hampered by a lack of suitable investigational~     techniques. Currently, ultrasound is the only widely used method of studying fetal anatomy~     and physiology, but it has significant limitations for assessment of cardiac rhythm. The~     proposed study will allow us to investigate fetal magnetocardiography (fMCG) as a new tool~     for the study of normal and abnormal fetal heart rate and rhythm, with a goal of~     demonstrating probable benefit from use of the device in patients with serious fetal~     arrhythmia. We propose a study that will last 1-2 years and will provide data to aid in~     assessing the safety and effectiveness of fMCG for diagnosis and management of patients with~     abnormal fetal heart rate and rhythm. We hope that the data from the study will support a~     Humanitarian Device Exemption (HDE) application for the subject device. The safety and~     efficacy study designs are described below. High-risk subjects will undergo echocardiography~     as part of their routine clinical management, and our results will be compared to the~     echocardiography results, as well as with postnatal ECG, when available. (Since many~     arrhythmias resolve prior to birth, either due to resolution of disease or due to treatment,~     only a limited number of diseases allow postnatal comparison). For rhythms that persist after~     birth, the diagnostic utility of fMCG and echocardiography will be assessed by computing the~     sensitivity (Sn) and specificity (Sp) relative to postnatal ECG for the following prenatal~     modalities: (i) the fMCG, (ii) the original (referral) echo, (iii) if available, the in-lab~     echocardiogram at the time of the fMCG study. Secondary endpoints will assess changes in~     diagnosis and in clinical management due to the additional information provided by fMCG,~     compared to the information provided by echocardiography alone.~   "
127118|NCT01903551|"~     The aim of the study is to evaluate whether loco-regional analgesia reduces post operative~     pain compared to intravenous analgesia, in patients undergoing cardiac surgery in~     minithoracotomy. All patients will be randomized to receive locoregional analgesia (treatment~     group) or intravenous analgesia (control group), at the end of the cardiac intervention.~   "
127119|NCT01903538|"~     Insufficient cognitive control over emotional distracters is characteristic for major~     depressive disorder (MDD). Hypoactivation of the dorsolateral prefrontal cortex (dlPFC) is~     associated with this deficit. In this study the investigators assess the effect of a decrease~     of dlPFC activity in healthy subjects by cathodal transcranial direct current stimulation~     (tDCS) on cognitive control.~      In a double-blinded, balanced randomized, sham-controlled crossover trial the investigators~     determine the effect of a single-session of cathodal tDCS to the left dlPFC on cognitive~     control in healthy subjects. To assess the cognitive control the investigators use a delayed~     response working memory task (DWM)and an arithmetic inhibition task (AIT) with pictures of~     varying valence.~   "
127129|NCT01903408|"~     For patients with prostate cancer and a high risk of lymph node involvement or confirmed~     pelvic lymph node metastases, radiotherapy of the whole pelvis is a treatment option.~     However, conventional radiotherapy of the pelvis has limited by gastrointestinal and~     urogenital side effects. The PLATIN trial investigates an intensity-modulated radiotherapy of~     the pelvic lymphatic drainage that spares small bowel, bladder and rectum. A higher dose is~     given during each session to the prostate or the prostate bed and to confirmed lymph node~     metastases. Prior to radiotherapy, two months of neoadjuvant antihormonal treatment are~     required, and continuation during radiotherapy and for a further two years are strongly~     recommended.~   "
127120|NCT01903525|"~     In recent years, media attention has focused on the long-term sequelae of repeated concussive~     episodes in professional athletes. The growing understanding of the damage done by what was~     once considered a ding during a game or match, and the neurologic consequences of playing~     through or returning to play too soon has led to additional interest in and concern for~     pediatric athletes (18 or under) who experience sports-related concussions during game or~     practice play.~      Because it has only been in recent years that the full scope of damage done by repeated~     concussive episodes has come to light, very little research has been done on treatment of~     concussion in either adults or children. Brain injuries in children can be especially~     problematic, as the brain may continue to develop until the child reaches the age of 24 or~     older, so concussion during this time of development may be particularly damaging.~      Docosahexaenoic acid (DHA) is an omega-3 fatty acid commonly found in both fish oils and~     algae. DHA is known to improve development of the eyes and brain in young children. It is~     thought to be an effective anti-inflammatory and anti-oxidant, and since it occurs naturally~     and causes very few harmful side effects, it may be a useful compound in the treatment of~     pediatric concussion.~      This is a feasibility trial of DHA for the treatment of sports concussion in a pediatric~     population. The investigators' primary aim is to determine acceptability of randomization for~     this compound as well as rate of enrollment given our clinical population. The investigators'~     secondary aim is to examine preliminary outcomes. The investigators hypothesize that subjects~     who take 2 g of DHA daily for 3 months will see a shorter time to full recovery and return to~     play and a shorter time to resolve balance disturbance. These are good, albeit unvalidated,~     clinical indicators of concussive recovery.~   "
127121|NCT01903512|"~     This study aims to evaluate the efficacy of arthrocentesis in the treatment of internal~     derangement of the temporomandibular joint (TMJ).~   "
127122|NCT01903499|"~     The satiety effects of beef will be compared to beans. Beef is hypothesized to be more~     satiating than beans.~   "
127123|NCT01903486|"~     Would systemic steroids be an effective treatment in early variants of achalasia?~   "
127124|NCT01903473|"~     The immune system has offensive and defensive capacities. In bone marrow transplantation,~     offensive cells in the donor grafts may attack host's organs, leading to a complication known~     as Graft versus Host Disease (GVDH). At present, patients receive steroid treatment to combat~     this tricky situation. Nevertheless, some patients do not respond to this therapy. Recently,~     it has been shown that immune system cells having defensive capacities can help in preventing~     the occurrence of a GVDH.~      This study aims to evaluate if these protective cells together with a non-standard~     immunosuppressor can improve the clinical condition and suppress the activity of the~     offensive cells in the graft.~   "
127125|NCT01903460|"~     The study is a randomized, double-blind, placebo-controlled study to evaluate the safety and~     tolerability of LUM001. Efficacy will be assessed by evaluating the effect of LUM001 versus~     placebo on the biochemical markers and pruritus associated with Alagille Syndrome.~   "
127126|NCT01903447|"~     Internalizing psychopathologies (IPs) involving depression and anxiety are among the most~     prevalent, costly and disabling illnesses. Treatments for IPs are available but the extent to~     which individual patients respond is quite heterogeneous. Little information exists,~     particularly in the biological domain, which helps to explain individual differences in~     treatment response. IPs share similar patterns of dysfunction within the Fronto-Limbic Affect~     Regulation and Emotional Salience (FLARES) brain circuit, and two commonly used, 'gold~     standard' treatments - selective serotonin reuptake inhibitors (SSRIs) and cognitive~     behavioral therapies (CBTs) - are equally effective for both anxiety and depressive~     disorders, and appear to change brain activity in the same areas within the FLARES circuit.~     The overarching goal of the project is delineate what are common versus specific FLARE brain~     targets for SSRI and CBT and identify specific aspects of FLARE dysfunction that might better~     predict response to both and to a specific modality of treatment. This experiment integrates~     emotion and its interaction with cognition across several stages of emotional experience,~     encompassing studies that probe sensitivity to acute and potential threat and automatic and~     volitional forms of affect regulation in relation to the FLARES brain network.~      We will enroll 200 patients presenting to our Mood and Anxiety Disorders Program seeking~     treatment for disabling 'anxiety, worry, depressed mood' (IPs, including those characterized~     as Not Otherwise Specified) and randomize them to a 12-week course of SSRI or CBT.~     Dimensional, transdiagnostic negative valence systems (NVS) constructs, including FLARES~     function, will be measured before and after each treatment. Specifically, the project will~     examine 2 Specific Aims: 1) Where and how do SSRI and CBT treatments exert their effects on~     NVS constructs?; and 2) Which NVS construct can predict the likelihood of success from SSRI~     and CBT treatment? Such findings can be used to guide the right patients to the right~     treatments with the highest likelihood of success. They also elucidate a~     pathophysiologically-driven mechanistic model of where and how treatments work in the brain~     and thus hasten the development of new treatments that target the underlying pathophysiology~     across internalizing conditions.~   "
127127|NCT01903434|"~     The purpose of this study is to measure and compare the amounts of the study drug evacetrapib~     found in the blood after taking two different formulations. The study has 3 periods.~     Participants will take each formulation by mouth at least once. A minimum of 14 days will~     pass between study drug doses. The safety and tolerability of the study drug will also be~     examined. Information about any side effects that may occur will also be collected. This~     study will last approximately 6 weeks.~   "
127128|NCT01903421|"~     Many elderly patients undergoing surgical procedures already have impaired cognitive~     (memory/concentration) status. Patients with pre-existing cognitive impairment, or dementia,~     may benefit from modified anesthesia techniques. It is estimated that one in eight people age~     65 and older has Alzheimers disease. More so, nearly half of people that are 85 years or~     older have Alzheimers disease. Currently, both spinal (regional) and inhalational (general)~     anesthesia, are used in patients undergoing common urological, orthopedic, and general~     surgical procedures. Inhalational anesthesia has been associated with higher risk of memory~     impairment in experimental (animal) and human studies. However, currently, there are simply~     no large or good enough studies to be sure that inhalational anesthesia is responsible for~     causing dementia and Alzheimers disease.The proposed study investigates if elderly patients~     (65 years and older) undergoing spinal anesthesia (patient is awake or slightly sedated) are~     less likely to develop dementia and Alzheimers disease for up to 2 years after surgery, when~     compared to inhalational anesthesia (patient is kept asleep with gas anesthetic). The~     investigators will also test all patients for the presence of apolipoprotein (ApoE-Îμ4 type~     of gene that is present in 15-20% of patients), and beta-amyloid tau protein (present in~     cerebrospinal fluid) that are known risk factors for Alzheimers disease. The particular~     strength of this study is that it takes into account whether the frequency and/or severity of~     dementia and Alzheimers disease is different in patients with and without these markers. The~     investigators believe that this study will make a major contribution to better understanding~     of development of Alzheimers disease.~   "
127146|NCT01903187|"~     The purpose of the EnligHTN IV clinical investigation is to demonstrate the safety and~     effectiveness of the EnligHTN™ Renal Denervation System in the treatment of subjects with~     drug-resistant uncontrolled hypertension.~   "
127147|NCT01903174|"~     This study is intended to support previous positive results of the AeroForm™ Patient~     Controlled Tissue Expander System for breast reconstruction~   "
127148|NCT01903161|"~     The purpose of this study is to evaluate delayed myocardial protective effect of RIPC in~     patients undergoing cardiac valve replacement surgery.~   "
127130|NCT01903395|"~     BACKGROUND: First-degree relatives of patients with colorectal cancer are at increased risk~     for colorectal cancer as well. Nevertheless, participation in the German national screening~     program stagnates at 2-3 percent per year even in this high-risk population.~      AIM: The study is aimed to increase the portion of the first-degree relatives on 50% which~     take up a preventive colonoscopy.~      METHODS: Cluster-randomized controlled multi-center trial. Study sites (clusters) are mainly~     certified cancer centers and office-based gastroenterologists from all over Germany.~     Index-patients with colorectal cancer of different stages are asked to hand over the study~     material to their relatives, consisting of an invitation to a nurse-led counseling on~     preventive colonoscopy and an one-to-one appointment with a clinical expert of one of the~     study sites next.~   "
127131|NCT01903382|"~     Mortality is subject to cyclic variability: circadian, weekly, and seasonal. This has been~     shown for different populations, different diseases and in different countries, but not for~     surgical patients. Aim of this study is therefore to investigate the association between~     circadian, weekly, and seasonal effects time of surgery postoperative mortality of patients~     undergoing surgery and general anesthesia.~   "
127132|NCT01903369|"~     The investigators would like to compare the stiffness inside and outside nerves using a~     special type of ultrasound imaging called shear wave elastography. Shear wave elastography is~     a special form of ultrasound as the pictures taken are in colour. An ultrasound machine has~     different ways of taking pictures of inside the body: one is by measuring the brightness of~     different body parts (often referred to as the B-Mode scan), the pictures taken in this way~     are the same as those you may have seen of unborn babies inside their mum's tummies; another~     way is by measuring the stiffness of different body structures which is how shear wave~     elastography works. The investigators hope that this new technology will help doctors to see~     the parts of the body that are important to them.~   "
127133|NCT01903356|"~     The primary objective of this study is to monitor the safety profile of Trajenta Duo in~     Korean patients with type 2 diabetes mellitus (T2DM) in a routine clinical setting.~   "
127134|NCT01903343|"~     The aim of the study is to assess the accuracy of shear wave elastography in volunteers.~     Shear wave elastography is a non-invasive, non-painful measure of tissue stiffness obtained~     using an ultrasound machine. It may be easier to think of shear wave elastography as a~     special type of ultrasound imaging which gives doctors a colour picture of body structures~     based on their stiffness.~   "
127135|NCT01903330|"~     This phase II clinical trial studies how well ERC1671 plus Granulocyte-macrophage~     colony-stimulating factor (GM-CSF) plus Cyclophosphamide with Bevacizumab works compared to~     Placebo Injection plus Placebo Pill with Bevacizumab in treating patients with~     recurrent/progressive, bevacizumab naïve glioblastoma multiforme and gliosarcoma (World~     Health Organization (WHO) grade IV malignant gliomas, GBM).~   "
127136|NCT01903317|"~     The purpose of this research study is to find out more about the relationship between vitamin~     D and psoriasis.~   "
127137|NCT01903304|"~     This is a prospective, randomized controlled nutrition intervention trial to determine~     immunological impact of high olive oil consumption in elderly. Aging is associated with~     impaired immune response which contributes to higher incidence of infections in elderly.~     Previously the investigators have shown that the type of fatty acids in the diet influences~     the immune response. In particular, reducing consumption of fats high in n-6 fatty acids has~     been shown to improve the immune response in aged. Very few studies have evaluated the role~     of olive oil, the main oil consumed as part of the Mediterranean diet on the immune response~     of elderly. The investigators hypothesize that high olive oil consumption will improve immune~     function in elderly. In addition, the investigators will investigate the effect of high olive~     oil consumption on gene expression of relevant pathways in circulating mononuclear cells, as~     well as on cognitive function.~   "
127138|NCT01903291|"~     The primary objective of the study is to estimate the annualized relapse rate (ARR) over a~     12-month period in patients with relapsing forms of multiple sclerosis (MS) who are treated~     with dimethyl fumarate (DMF) after suboptimal response to glatiramer acetate (GA). The~     secondary objectives of this study in this study population are to assess the impact of DMF~     over a 12-month period on patient-reported outcomes (PROs) and health economic-related~     outcomes and to evaluate additional clinical outcomes at Month 12.~   "
127139|NCT01903278|"~     This study is to confirm the potential effects and assess the safety of a new bio-product~     Pegylated Recombinant Consensus Interferon Variant Solution for Injection (PEG-IFN-SA) and~     Ribavirin（RBV） in the treatment of Chronic hepatitis C who have not been previously treated~     with Interferon.~   "
127140|NCT01903265|"~     TNX-102 capsules [formerly known as very low dose (VLD) cyclobenzaprine] at bedtime have~     shown promise as a treatment of fibromyalgia, but the drug required new formulation~     technology for bedtime use. The present trial was designed to assess the safety and efficacy~     of TNX-102 SL 2.8 mg tablets, taken daily at bedtime over 12 weeks to treat fibromyalgia.~   "
127141|NCT01903252|"~     The purpose of this research study is to compare the medication TP05 to the medication~     Asacol™ for the treatment of ulcerative colitis (UC) and to assess the safety and~     tolerability of TP05. This study will investigate whether TP05 is as good as (non-inferior~     to) Asacol™.~   "
127142|NCT01903239|"~     The purpose of this study is to determine the narrowest excision margin for head and neck~     Basal Cell Carcinoma (BCC) tumors satisfying the National Comprehensive Cancer Network®~     (NCCN) low-risk for recurrence clinical and histopathological criteria that gives an~     acceptable (95%) clinical cure-rate over a 3 year follow-up period. Margins of 1 and 2mm are~     evaluated.~   "
127143|NCT01903226|"~     The aims of this study are to assess the effects of medium versus high intensity 12-week~     adjusted training programs on physical capacity in persons with incomplete SCI, early after~     discharge from primary rehabilitation, and to investigate if the training program induces a~     more active lifestyle in terms of increased daily energy expenditure.~   "
127144|NCT01903213|"~     To evaluate the safety and efficacy of long-term use of Kiklin® Capsules in actual clinical~     settings.~   "
127145|NCT01903200|"~     The objective of the study was to evaluate the safety and plasma concentration changes of~     quetiapine after multiple oral administration of FK949E (extended-release formulation of~     quetiapine) in elderly patients with major depressive disorder (MDD).~   "
127150|NCT01903135|"~     Rationale of the BIO-OHS study (Prevalence of Obesity Hypoventilation Syndrome):~      The overall prevalence of Obesity Hypoventilation Syndrome (OHS) has never been directly~     assessed in the general population. Actually, this prevalence has been assessed in patients~     referred to sleep clinics with a potential diagnosis of sleep-disordered breathing or in~     patients already diagnosed with sleep apnea. The purpose of this study is to determine the~     prevalence of Obesity Hypoventilation syndrome in obese patients referred to clinical~     laboratories for regular follow-up medical analysis.~   "
127151|NCT01903122|"~     The objective of this study was to prove the bioequivalence of Roxane Laboratories'~     Cevimeline 30 mg under fasted conditions~   "
127152|NCT01903109|"~     The objective of this study was to prove the bioequivalence of Roxane Laboratories'~     Cevimeline 30 mg under fed conditions~   "
127153|NCT01903096|"~     The strong demand for primary care (PC) services in Spain exceeds resources. Part of this~     demand is due to the increasing number of anxiety, depression, and somatization disorders~     that affect the general population. These disorders, commonly known as emotional disorders,~     are very common in Spanish PC settings, they are poorly detected by physicians, rarely~     receive adequate treatment (if they receive treatment it is mostly drugs instead of~     psychological treatment), they generate a highly frequent use of PC services, a greater~     burden than physical diseases and tend to become chronic without treatment.~      Other countries have successfully put psychological techniques in PC into practice (in the~     United Kingdom the program known as Improving Access to Psychological Therapies has~     obtained very positive results) in order to correctly diagnose and treat emotional disorders.~     The results obtained in terms of symptoms, quality of life, diagnosis, etc., have been better~     than the usual treatment offered in PC services, involving no side effects, fewer relapses,~     and lower costs in the long term.~      The general aim of this study is to test how well a psychological treatment program for~     anxiety, depression, and somatization disorders works in PC and to compare the results~     obtained after seven 90-minute group sessions (every to two to four weeks approximately, for~     a period of 24 weeks) with the usual treatment offered in Spanish PC services. Similar~     results to the ones already obtained in other countries are expected to be found.~      Approximately 1130 adults, regardless of their age and sex, with an anxiety, depression~     and/or somatization disorder (diagnosed with a simple and short questionnaire) will~     participate in this study.~      Participation will be voluntary and confidentiality will be guaranteed. Half of the~     participants in the study will be randomly assigned to receive their usual care and the other~     half will receive psychological treatment, within the same health care centre. Since it is a~     double-blind study, neither the health professional nor the patient will know which~     treatment will be applied. Psychological assessments will be carried out before and after~     receiving treatment and participants will be followed up at 3, 6 and 12 months.~      Participation will pose no risks different from the typically present when receiving usual~     treatment. The aim of this study will be to maximize benefits and reduce potential harms~     (principle of proportionality).~   "
127154|NCT01903083|"~     The goal of this study is to evaluate the safety of combination treatment that includes~     chemotherapy, radiation therapy, and immunotherapy in patients with pancreatic cancer.~   "
127155|NCT01903070|"~     This is a bi-centric, prospective, open study comparing the effects of linagliptin on active~     GLP-1 concentrations in subjects with renal impairment compared to subjects with normal renal~     function.~   "
127156|NCT01903057|"~     Trachoma and lymphatic filariasis (LF) are two 'Neglected Tropical Diseases' (NTDs),~     infectious diseases that affect millions of poor people in countries in the developing world.~     Trachoma is an eye infection that can lead to painful scarring of the eyelids and blindness~     later in life. LF can lead to swelling of usually the limbs (elephantiasis).~      Trachoma and LF are preventable and treatable diseases. One important treatment strategy is~     annual Mass Drug Administration (MDA): Communities receive drug treatment once a year.~     Azithromycin is given for trachoma. Ivermectin and albendazole are given for LF.~      Trachoma MDA and LF MDA are currently separated campaigns. Combined MDA campaigns for~     trachoma and LF, where three drugs would be given at one time, would reduce costs and~     decrease the burden on the health system.~      Before combined MDA with three drugs (azithromycin, ivermectin and albendazole) could be~     recommended, we would have to demonstrate that the safety profile of this treatment with~     three drugs is acceptable. An earlier study in Mali in 2010 (AZIVAL) comparing standard MDA~     (one week space between the two MDA campaigns) with combined MDA (trachoma and LF MDA on the~     same day) showed that the safety profiles were comparable; but the results of the study were~     not statistically significant and we could not use them to make an official recommendation.~      The AZIVAL 2 study has been designed to answer the questions that remain after the AZIVAL~     study performed in Mali in 2010. If the safety results of the AZIVAL 2 study are acceptable,~     an official recommendation for combined MDA with azithromycin, ivermectin and albendazole can~     be drafted.~      We will conduct the AZIVAL 2 study in Mozambique. The target population (inclusion and~     exclusion criteria) is the same as in the AZIVAL study in Mali. Main criteria are: Age ≥ 5~     years and ≤ 65 years, height ≥ 90 cm, if female, not pregnant or breast-feeding.~      Important differences between the AZIVAL study and the AZIVAL 2 study are a) smaller clusters~     for sufficient power (average household size is 5 people), b) placebo to double-blind~     participants and study staff for azithromycin, c) the study area will have undergone fewer~     previous rounds of MDA for LF and none for trachoma, and d) smartphones for data entry.~   "
127157|NCT01903044|"~     The purpose of this study is to determine whether autologous bone marrow-derived stem cells~     are effective in the treatment of lower extremity ischemia.~   "
127158|NCT01903031|"~     This study was done to look at a method of hormonal birth control, called the NuvaRing, and~     specific anti-HIV medications, called antiretrovirals (ARVs). Some studies of women who use a~     hormonal birth control method (specifically oral pills, patches, and injections) and take~     ARVs have shown that ARVs interact with the hormones released by the birth control~     medication. These interactions may cause the birth control to be less effective at preventing~     pregnancy. There is also concern that hormonal birth control can increase HIV spreading to~     others, but more studies are needed to determine if this is true. The investigators did not~     know whether the NuvaRing and ARVs interact when they are used together, so this study looked~     to see if certain ARVs (efavirenz and atazanavir/ritonavir) interact with the two hormones~     released by NuvaRing. This will help us to determine if NuvaRing is safe and effective for~     women with HIV infection who are taking ARVs. The study also included HIV-infected women who~     were not on ARVs but used the NuvaRing to show us what the hormone levels are like in a~     similar group of women not on ARVs.~      Vaginal rings are also currently being studied to deliver anti-HIV medications that may~     prevent HIV acquisition, and to provide birth control over a longer period of time (more than~     1 month). Since vaginal rings will become more commonly used to administer medications, the~     investigators wanted to better understand the potential for drug interactions with drugs~     given vaginally. This study will also help us understand the potential for drug interactions~     between ARVs given orally, and other drugs given through vaginal rings, like the NuvaRing.~     Additionally, this study will help us understand how hormones released from a vaginal ring~     affect the amount of HIV virus in the genital tract, the bacterial make-up (microbiome) of~     the female genital tract, and the immune system within the genital tract, all of which may~     affect the chances of spreading HIV.~   "
127159|NCT01903018|"~     A Clinical Study to Assess Radiation Induced Mucositis in Subjects with Locally Advanced~     Squamous Cell Carcinoma of the Head and Neck~   "
127160|NCT01903005|"~     The purpose of this study was to assess safety, efficacy, and treatment retention following~     extended treatment with OX219, a higher-bioavailability buprenorphine/naloxone (BNX)~     sublingual tablet formulation in opioid-dependent patients who completed 1 of 2 primary~     efficacy and safety studies of OX219.~   "
127161|NCT01902992|"~     This study will assess efficacy and safety of intraseasonal specific short-term immunotherapy~     with Depiquick® Birch in patients with allergic rhinitis and or rhinoconjunctivitis with or~     without intermittent asthma that have a clinical relevant IgE-mediated allergic sensitization~     against birch pollen. The term intraseasonal means that patients will start with~     immunotherapy treatment during the birch pollen season, i.e. when the already experience~     allergic symptoms.~   "
127578|NCT01897493|"~     The main purpose of this study is to determine how much digoxin gets into the blood stream~     and how long it takes the body to get rid of it when given with the study drug evacetrapib.~     This study will also look at the effect of evacetrapib on the removal of digoxin from the~     body by the kidneys. Information about any side effects that may occur will be collected.~     This study will last approximately 33 days for each participant, not including screening.~   "
127162|NCT01902979|"~     Obesity is one of the most important determinants of quality of life and function. People~     with lumbar spinal stenosis may be at increased risk of obesity given walking limitations.~     Spinal stenosis is a very common degenerative condition in people over 45. People with this~     condition have pain and numbness in the legs during walking, and therefore avoid physical~     activity. Lack of physical activity is related to weight gain and increased risk of chronic~     disease. Objective: The objective of this project is test a new e-health (online) pedometer~     and nutrition intervention aimed at promoting weight loss and increasing physical activity in~     overweight and obese individuals with spinal stenosis. Methods: The investigators will~     recruit 88 people with lumbar spinal stenosis who are overweight or obese. Half of these~     people will receive the 12-week intervention, and the other half will receive usual care (no~     intervention). In Weeks 1 and 6, people in the intervention group will meet with a Registered~     Dietitian and an Exercise Physiologist for personalized sessions. They will receive a~     pedometer and instructions on how to log in to the e-health site~     (https://sspanli.mtroyal.ca). They will wear the pedometer daily and log in to the website~     each week for a nutrition education session, a weekly step goal, and tips. The investigators~     will look to see whether people in the intervention group show greater change in physical~     activity, body composition and quality of life compared to the individuals who received usual~     care. Relevance: The increasing number of people with spinal stenosis represents a huge~     health care burden in Canada. This intervention could provide a new treatment option that~     would increase mobility, quality of life, and potentially alleviate the need for expensive~     treatments like surgery. E-health interventions provide an opportunity for patients to take~     an active role in their own health, and promote behaviour changes that will result in~     healthier Canadians less likely to access care in the future.~   "
127163|NCT01902966|"~     The goal of this clinical research study is to learn how many patients with advanced,~     recurrent, incurable cervical cancer will complete questionnaires about symptoms, any~     anxiety, depression, and/or pain, and the quality of their lives. Researchers also want to~     learn how many of these patients will complete a study treatment of propranolol hydrochloride~     and relaxation and guided imagery sessions.~      Researchers also want to learn if and how propranolol hydrochloride and relaxation and guided~     imagery may affect cancer symptoms and any anxiety, depression, and/or pain, and quality of~     life.~      Propranolol hydrochloride is designed to block certain chemicals that affect the heart.~      Relaxation and guided imagery sessions are a form of relaxing meditation that involves~     tensing and relaxing various parts of your body from your feet to your head. In the guided~     imagery portion, you listen to recordings that are designed to help with calmness, control,~     and decreasing stress.~   "
127164|NCT01902953|"~     45 patients undergoing a colon (large bowel/intestine)removal operation for the diagnosis of~     colon cancer will be included in this study. During colon operation the affected portion of~     the colon is removed. In addition, lymph nodes are included in the specimen and evaluated by~     a pathologist. Analysis of the lymph nodes in the specimen are important because this is an~     important aspect of determining the stage of the cancer.~      Once the standard technique is used for the colon removal operation and the specimen is~     removed it will be injected with two drugs to help identify the lymph nodes. One is a blue~     dye and the other a radiotracer. The colon and ALL of the lymph nodes will then be sent for~     the standard pathologic evaluation. The patient themselves will never be injected with these~     drugs being used for research.~      Following the standard lymph node evaluation, an additional pathologist at an outside~     research facility will further examine the lymph nodes in the specimen using more in depth~     techniques which are above and beyond the standard of care.~      The results of all the pathologic tests will be conveyed to the surgeon of record to help in~     their decision making regarding further treatment.~      The study hypothesis is that radiotracer will be at least as effective as blue dye in~     identifying the lymph nodes most likely to harbor cancer cells (sentinel nodes). Once~     identified, these sentinel nodes can then undergo a more in depth review leading to improved~     staging of colorectal cancer and more accurate treatment.~   "
127165|NCT01902940|"~     So far, only limited data is available regarding the natural course in Congenital Cataract~     Facial Dysmorphism Neuropathy Syndrome (CCFDN) and sporadic and hereditary inclusion body~     myopathies (IBM). Several criteria and outcome measures have led to contradicting results.~     The investigators want to retrospectively assess the natural course of the disease in CCFDN~     and IBM patients according to the data recorded during clinical routine visits.~   "
127166|NCT01902927|"~     Chronic obstructive pulmonary disease (COPD) is a major health problem whose prevalence is~     increasing rapidly. The gradual decrease in exercise tolerance is one of the usual~     consequences of COPD that affects the functional independence and quality of life of~     patients.~      In COPD patients, breathlessness and muscle fatigue are the main symptoms limiting exercise.~     Recent studies have shown that most of the physiological mechanisms of psychological factors~     such as emotions, motivation, memory, personality, expectations, or prior experience can~     greatly influence and modulate the perception of breathlessness. It has been proposed that~     the attentional distraction (visual or auditory) during exercise may be associated with a~     decrease in anxiety and shortness of breath and could improve exercise tolerance in COPD. We~     therefore propose to study the impact of attentional strategies of distraction on the~     perception of dyspnea and walking tolerance in patients with COPD.~      The research hypotheses are:~      i) Compared with exposure to a strategy of negative attentional distraction during exercise,~     exposure to a strategy of positive attentional distraction will improve walking exercise~     tolerance in patients with COPD;~      ii) For a given level of effort, sensory perception and emotional perception will be enhanced~     by exposure to a strategy of positive attentional distraction.~      Ten subjects with moderate to severe COPD will be recruited at the Research Center of the~     Institut Universitaire de cardiologie et de pneumologie de Québec (CRIUCPQ). During an~     assessment visit, we will measure complete pulmonary function, body composition and maximal~     functional capacity during a maximal incremental test work performed on a treadmill.~      During two subsequent experimental visits, and after spirometry control, participants will~     perform a walking test performed on a treadmill at an intensity corresponding to 75% of~     maximum effort during maximal incremental test. The test will be carried out in combination~     with a strategy of either positive attentional distraction, neutral attentional distraction~     or negative attentional distraction . The order of the condition will be randomized.~   "
127167|NCT01902914|"~     To test the effectiveness of body-worn, digital hearing aids, model 02 which is developed by~     the National Electronics and Computer Technology Center, Thailand.~   "
127168|NCT01902901|"~     This study is conducting a randomized controlled trial (RCT) with up to 400 subjects (women &~     partners) seeking pre-conception carrier testing to assess the impact of the program using~     Whole Genome Sequencing (WGS).~        1. The investigators hypothesize that whole genome sequencing will increase the detection~          of carrier status for Mendelian recessive and x-linked conditions.~        2. The investigators hypothesize that parents will act on the knowledge of their carrier~          status by making different reproductive choices than parents who do not receive this~          information.~        3. The investigators hypothesize that the psychosocial risks are increased among parents~          who receive expanded carrier screening using Next Generation Sequencing (NGS) compared~          with usual care.~   "
127169|NCT01902888|"~     This is a multicenter, non-randomized, single arm, retrospective study of GORE® VIABAHN®~     Endoprosthesis for the treatment of a Popliteal Artery Aneurysm (PAA).~   "
127170|NCT01902875|"~     This clinical Trial is proposed to explore whether preconditioning chemotherapy of~     Paclitaxel+cisplatin(TP)regimen combined with autologous adoptive CIK cell immunotherapy~     could benefit NSCLC patients with a better clinical outcome.~   "
127171|NCT01902862|"~     The purpose of this study is to evaluate the efficacy (effectiveness) and tolerability (how~     well a participant can stand a particular medicine or treatment; ability to be used) of~     bortezomib in combination with rituximab standard therapy (medicine or medical care given to~     a participant for a disease or condition) in participants with relapsed or refractory (not~     responding to treatment) follicular lymphoma (a cancer of the lymph nodes [or tissues] in~     follicle).~   "
127172|NCT01902849|"~     Knowing the fact that the anesthetic substances can alter the immune response during the~     surgery, the purpose of the study is to evaluate the influence of two general anesthetic~     techniques - inhalation vs. total intravenous anesthesia on the immune response in patient~     with colorectal surgery for neoplastic disease, evaluated by the plasma level of the~     interleukins 6 and 10(IL6, IL10).~   "
127173|NCT01902836|"~     Patients with atopic dermatitis treated with conventional treatment plus Dialyzed Leukocyte~     Extracts (DLE-oral Transferon) as adjuvant, have better clinical outcome than patients~     treated only with conventional treatment.~   "
127174|NCT01902823|"~     There is widespread anecdotal evidence that Cancer Nurse Navigators (CNNs) are highly valued~     by cancer patients, but no studies have evaluated the effects of CNNs on important~     patient-reported outcomes or indicators of quality of care. This study has two aims:~        1. To assess the feasibility of studying the impact of Aurora CNN Program.~        2. To pilot test the effects of CNN services on patient-reported outcomes and indicators of~          quality of care.~   "
127175|NCT01902810|"~     This efficacy and safety trial will examine the effects and safety of propranolol~     administered to adult patients with severe burn injury. The investigators hypothesize that~     propranolol will provide significant benefit to adults following severe burn injury at doses~     that are safe and do not increase risk of adverse infectious and non-infectious outcomes.~   "
127176|NCT01902797|"~     According to the World Malaria Report, there were significant decreases in the number of~     P.falciparum (PF) malaria cases worldwide in the past decade. On the Thai-Myanmar border~     where transmission is low and seasonal and where incidence of Multi-drugs resistant~     P.falciparum parasites is the highest, the same trend has been observed with a clear decline~     in malaria episodes and the ratio of P. falciparum/P. vivax (PF/PV.~      Economic development, unprecedented financial support, renewed efforts in vector control, a~     wider use of rapid diagnosic tests (RDTs) for malaria and the deployment of artemisinin based~     combination treatments (ACT) are the main contributing factors to those successes against~     malaria.~      However the emergence in Cambodia and on the Thai-Myanmar border of P.falciparum isolates~     that exhibit resistance to artesunate is threatening those gains . This is characterized by a~     slow parasite clearance rate observed in patients treated with artesunate.~      At the same time, recent SMRU surveys along the Thai-Burmese border using a new cutting-edge~     technology i.e. highly sensitive quantitative Real Time PCR (RT-PCR) able to detect very low~     parasitaemia (10 parasites per ml), found up to a 3-5 fold increase in the prevalence of~     malaria compared to what is found with the usual diagnostic tools such as microscopy, RDT or~     even conventional PCR.~      It seems that a large number of asymptomatic carriers with very low parasites counts (a large~     potential malaria reservoir) go undetected. If confirmed, this might pose the greatest~     obstacle for malaria elimination in the region and containment of artemisinin resistance.~      The purpose of the survey is to further study and understand the epidemiology of malaria in~     the refugee camp population using cutting-edge technology (RT-PCR) .~   "
127177|NCT01902784|"~     Research Protocol Abstract:~      This is a phase II controlled trial (RCT) of a storytelling intervention compared to no~     treatment among surrogates who have participated in a decision to limit life-sustaining~     treatment in the ICU for an incapacitated loved one. Subjects will be sequentially assigned~     to storytelling (a facilitated elicitation of the experience 2-4 weeks after bereavement)~     or no treatment with follow up monitoring of well-being. Subjects will receive print~     bereavement brochures at 1 week, and undergo telephone symptom assessment at 2-weeks,~     3-months, and 6-months after bereavement.~   "
127178|NCT01902771|"~     DC vaccine manufactured and partially matured using our standard operating procedures,~     developed in collaboration with the HGG Immuno Group, then administered through imiquimod~     treated skin will be safe and feasible in children with refractory brain tumors. This will~     result in anti-tumor immunity that will prolong survival of subjects treated and results will~     be consistent with the outcomes found for subjects treated by HGG Immuno Group investigators.~     Study treatment will correlate with laboratory evidence of immune activation. Correlative~     studies will also reveal targets in the immune system which can be exploited to improve~     response for patients on successor trials.~   "
127179|NCT01902758|"~     This study is being conducted to determine the effectiveness of using two FDA approved~     medications in concert to reduce the likelihood of sickness due to low oxygen levels and to~     reduce the decrement in physical performance at higher elevations. The investigators~     hypothesize that this drug combination will reduce the symptoms of acute mountain sickness~     and improve exercise performance at high altitude compared to placebo.~   "
127180|NCT01902745|"~     There are over 2 million breast cancer survivors today. Persistent cancer-related fatigue~     (PCRF), a state of being tired or weary, is one of the most common and distressing symptoms~     experienced by breast cancer (BC) survivors. PCRF is associated with decreased quality of~     life, decreased sleep quality, depression, chronic pain and impaired cognition. Currently,~     there are few treatment options for PCRF and existing treatment options are associated with~     significant costs, are a considerable burden on the part of the patient, or have unacceptable~     side-effects. As such, there is a clear need to conduct studies evaluating the impact of~     safe, easy to implement and inexpensive treatments for PCRF in BC survivors.~      Individualized nutritional counseling has been found to be beneficial for decreasing fatigue~     and improving quality of life in cancer patients receiving treatment.However, there is a~     dearth of research examining the use of diet for treating fatigue in cancer survivors. Our~     preliminary data in 40 adult cancer survivors found that fatigue severity was associated with~     decreased intake of key food groups, e.g., green leafy vegetables, and nutrients, e.g.,~     omega-3 fatty acids, as reported in diet records. However, diet records are often not highly~     correlated with actual nutrient concentrations in the body and tend to capture short-term~     dietary habits not long-term patterns. The main objective of this research is to expand upon~     and confirm our cross-sectional preliminary data and to take advantage of a pilot clinical~     dietary study we are conducting by examining key nutrient differences in biological samples~     in the breast cancer survivors. By examining differences in biological samples we will be~     able to explore three key questions, which will directly influence our future interventional~     studies: (1) to determine if there are actual differences in concentrations of key nutrients~     in body tissue and which nutrients these are; (2) to assess if a dietary intervention focused~     on improving fatigue in BC survivors changes baseline levels of key nutrients; and (3) what~     is the effect size and variability of change in key nutrients in body tissue both at baseline~     and after a dietary intervention.~   "
127674|NCT01896219|"~     Estimate the medical service of a system of navigation (IMACTIS-CT®)in terms of SAFETY,~     EFFICIENCY and PERFORMANCE, in comparison with the reference method during gestures of~     interventional radiology under scan in the thoraco-abdominal level.~   "
127182|NCT01902719|"~     African Americans represent a particularly vulnerable subgroup of persons with hypertension,~     as they are more likely than Whites to have hypertension, equally as likely to be aware of it~     and to be treated for it, but less likely to achieve blood pressure control while receiving~     treatment. African Americans are also more likely than Whites to suffer end organ damage as a~     result of hypertension. Patients' hypertension self-management behaviors (including adherence~     to prescribed care, self-blood pressure monitoring, lifestyle changes, and shared medical~     decision-making) represent a cornerstone of hypertension therapy. Evidence suggests some~     African Americans with hypertension may experience difficulties carrying out positive~     self-management behaviors, in part due to cultural beliefs and practices, knowledge and~     perceptions regarding the nature and consequences hypertension, and lack of systems to~     support ongoing engagement in prescribed care within their communities. Substantial evidence~     has demonstrated the important role of family and community support in improving patients'~     management of a variety of chronic illnesses.~      The goal of this study is to rigorously test the effectiveness of hypertension~     self-management interventions that engage African American patients, their families, and~     their community-level resources to improve African American patients' blood pressure.~      We hypothesize patients' hypertension control rates may be improved when combining community~     health worker self-management support with other types of hypertension self-management skills~     training.~   "
127183|NCT01902693|"~     Human Immunodeficiency Virus (HIV) infection is very successfully treated with a type of~     therapy called Highly Active AntiRetroviral Therapy (HAART). Although HAART has made a great~     improvement to the health and lives of all people living with HIV, HAART cannot be stopped~     because it is not able to 'cure' or eliminate the HIV virus from all cells in the body - the~     remaining viruses are referred to as 'latent' or sleeping virus. As soon as the HAART~     treatment is stopped the virus comes back (wakes up). It is for this reason that stopping~     HAART treatment is not recommended. However, it may be that other drugs if given with HAART~     could have a stronger effect on the latent virus. There is some evidence from laboratory~     research that suggests that some of the drugs we use to treat certain types of cancer may~     have an effect on the latent virus. The purpose of this research study is to use new~     laboratory research technology to measure the amount of 'latent' virus in people who are~     treated with HAART who then need to use chemotherapy treatments for cancer. We will look at~     whether the levels of HIV virus are reduced in patients having chemotherapy by looking at the~     virus levels before, during and after chemotherapy treatment. We do not know very much about~     how HIV persists in the body despite therapy and unless new approaches are developed, removal~     of the HIV virus from all cells in the body will not be possible.~   "
127184|NCT01902680|"~     This is a pilot prospective biomedical study of interventional type which includes 17~     patients on 24 months (12 months of inclusion and 12 months of follow-up).~      The objective of this study is to verify that the focal therapy technique used (with the help~     of Koelis® system) allows to obtain optimal dosimetric coverage of the prostate target (ie~     dose of 160 Gy +-5% delivered on the envelope isodose) evaluated by CT scan performed 30 days~     after implantation.~   "
127185|NCT01902667|"~     This is a prospective observational study in which patients with untreated retroperitoneal~     sarcoma will have Magnetic Resonance Imaging (MRI) prior to surgery. In addition, patients~     who will be undergoing pre-operative radiotherapy will have an additional MRI scan at two~     weeks post radiotherapy. For both groups, the magnetic resonance images will be correlated~     with tumour pathology.~      The study hypothesis is that Magnetic Resonance Imaging will provide a more accurate~     assessment of tumour volume and local staging than CT and will identify areas of altered~     oxygenation, cellularity and perfusion which change in response to radiotherapy before tumour~     shrinkage occurs.~   "
127186|NCT01902654|"~     We analyze retrospectively the relationship between traditional cardiovascular risk factors~     as hypertension, obesity, dislipidemia and diabetes and hand or knee osteoarthritis and we~     compare the results with a control groups of patients with soft tissue disease with no other~     rheumatologic condition.~   "
127187|NCT01902641|"~     Succinylcholine is commonly used for neuromuscular relaxation for short procedures such as~     rigid bronchoscopy. A more modern alternative is the application of low-dose rocuronium,~     reversed by low-dose sugammadex. The investigators compare the intubating conditions,~     incidence of postoperative myalgia (POM), as well as patient satisfaction for these two~     muscle relaxants.~   "
127188|NCT01902628|"~     This prospective observational study will evaluate the efficacy and safety of Mircera~     (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease patients not on dialysis~     with renal anemia. Patients initiated on treatment with Mircera according to the Summary of~     Product Characteristics and standard clinical practice will be followed for 10 months.~   "
127189|NCT01902615|"~     This multicenter, retrospective, observational study will evaluate the therapeutic~     effectiveness of a strategy of induction with Fuzeon (enfuvirtide) within an optimized~     regimen of antiretroviral drugs in patients with HIV-1 infection in routine clinical~     practice.~   "
127190|NCT01902602|"~     The objective of this clinical study is to evaluate the influence of the Great~     autohemotherapy with oxygen-ozone (hyperbaric ozone therapy ) to describe the cardiovascular~     system in patients with resistant hypertension. The primary endpoint is the change in mean~     blood pressure after 10 treatments .~      In addition, data are collected on the immune system as well as for food and sleep quality.~   "
127191|NCT01902589|"~     Helicobacter Pylori (HP) is one of the most common pathogens in humans. This infection can~     present in children with abdominal pain, vomiting and iron deficiency. The treatment is~     usually empiric and includes antibiotic treatment usually Amoxycillin and Clarithromycin or~     Metronidazole. Between 40 to 70 % of the pathogens are resistant to those drugs, and it is~     important to characterize the specific sensitivity of the pathogens in any specific area and~     in pediatric population. The aims of this study is to assess the sensitivity of HP in~     pediatric population in Northern Israel.~   "
127192|NCT01902576|"~     The purpose of this study is to develop and validate endpoint measures that can accurately~     determine whether patients are responding to treatment for chronic Graft-versus-Host Disease~     (GVHD). Hopefully, this will also lead to being better able to predict which patients will~     respond to what therapies.~   "
139029|NCT01747538|"~     The purpose of this study is to evaluate the efficacy of gevokizumab in reducing the risk of~     recurrent uveitic disease in subjects with non-infectious uveitis whose disease is currently~     controlled with systemic treatment.~   "
127193|NCT01902563|"~     Background Several studies have shown the effect of osteopathic manipulative treatment on~     neonatal care in reducing length of stay, gastrointestinal problems, clubfoot complications~     and improving cranial asymmetry of infants affected by plagiocephaly. Despite several results~     obtained, there is still lack of standardized osteopathic evaluation and treatment procedures~     for newborns recovered in neonatal intensive care unit (NICU).~      The aim of this research is to provide a guideline on osteopathic approach in treating~     hospitalized newborns. Specific evaluation tests and treatments have been developed to tailor~     osteopathic method according to preterm and term infants' needs, NICU environment, medical~     and paramedical assistance.~   "
127194|NCT01902550|"~     The purpose of this study is to evaluate effect of co-administration of JNJ-54452840 and~     metoprolol tartrate immediate-release (metoprolol IR) compared to metoprolol IR alone on the~     exercise heart rate and blood pressure measured at the end of each 3-minute exercise test in~     healthy participants.~   "
127195|NCT01902537|"~     The purpose of this observational study is to investigate health related quality of life~     (QoL) in Korean female participants with chronic constipation (long term decreased number of~     or difficulty making bowel movements) having received treatment previously.~   "
127196|NCT01902524|"~     The purpose of this study is to confirm effectiveness and safety of fentanyl transdermal~     patch Durogesic® D-Trans for treatment of chronic pain in participants with chronic~     non-cancer pain.~   "
127197|NCT01902511|"~     This will be a randomized double blind study which will be conducted on patients admitted to~     Department of Hepatology from June 2013 to may 2014 at ILBS, New Delhi. Patients not having~     any exclusion criteria will undergo bone marrow examination and liver biopsy at the baseline.~      60 patients of decompensated cirrhosis will be randomised into two limbs- limb A (30~     patients) will receive G-CSF and erythropoietin while those on limb B (30 patients) will~     receive G-CSF alone. The drugs will be given for 2 months and patient will be followed for 1~     year. G-CSF will be given at a dose of 5 µg/kg s/c at days 1, 2, 3, 4, 5 and then every 3rd~     day till day 60 (total 22 doses). Erythropoietin will be given s/c at dose of 500 IU/Kg twice~     a week for 2 months.~      Follow up will be done on days 0,3,7,14,28, day 42 (6 weeks), day 60 (2 months), day 90 (3~     months), day 180 (6 months), day 270 (9 months); and day 360 (1 year).~   "
127198|NCT01902498|"~     Cardiac bypass surgery is an important treatment for patients with severely blocked arteries~     (tubes that delivery oxygen and nutrients to the heart). Hundreds of thousands of these~     operations are done each year to help relieve patients' chest pain and to prevent future~     heart attacks. The surgery is done by bypassing blood flow around badly clogged arteries by~     sewing on healthy vessels from another part of the body (usually from the leg or the chest).~     Aspirin (a blood thinner) is given to patients once a day after their surgery because it~     stops sticky cells in the blood (platelets) from blocking these new vessels (which may lead~     to a future heart attack).~      Research has shown that aspirin does not work as well in people after they have bypass~     surgery as the investigators might expect (for reasons that are not fully understood). One~     reason aspirin may not work as well after surgery is because the body makes many more~     platelets after surgery than it would under normal circumstances. All of these new platelets~     overwhelm the aspirin and continue to be sticky and ready to block off arteries. The~     investigators believe that giving multiple daily doses of aspirin following bypass surgery is~     more effective at blocking platelet activity than giving aspirin once daily.~   "
127199|NCT01902485|"~     This study will compare immediate to post-abortion start of two progestin-based~     contraceptives (DMPA and etonorgestrel implants) among women having first trimester medical~     abortion who wish to use that method for post-abortion contraception.~   "
127200|NCT01902472|"~     This study will evaluate HIV-1 RNA and the presence or absence of resistance at baseline and~     following seroconversion, assess the frequency of HIV-1 screening and screening method(s)~     used for evaluation of seroconverters, and collect information regarding whether the~     seroconverter experienced signs and symptoms of acute HIV-1 infection prior to or at the time~     of seroconversion.~   "
127201|NCT01902459|"~     The objective of this study is to evaluate the clinical utility of EVARREST™ Fibrin Sealant~     Patch (Fibrin Pad) as an adjunct to hemostasis in soft tissue bleeding during intra-abdominal~     (stomach area), retroperitoneal (hip and stomach area), pelvic (hip area) and non-cardiac~     thoracic (chest area) surgery.~   "
127202|NCT01902446|"~     Traumatic injury in rural America is a significant cause of morbidity and mortality, and the~     challenges of a rural trauma system can put patients at unique risk. Prolonged transport~     times to a trauma center, stopping for care at referring hospitals, and longer exposure to~     care-associated factors distinguish rural patients from their urban counterparts.~     Ventilator-associated pneumonia (VAP) is a significant risk in rural patients, increasing~     hospital stay, healthcare costs, and even mortality in the critically injured. The~     investigators propose a pilot study to test the hypothesis that a single dose of oral~     chlorhexidine gluconate (antiseptic) for trauma patients in the prehospital environment will~     decrease subsequent development of early VAP. Chlorhexidine is currently a standard therapy~     in intensive care units to prevent airway colonization and subsequent development of VAP.~     Demonstrating safety and effectiveness of prehospital infection control practices could~     significantly improve outcomes of traumatic injury in rural America.~   "
127203|NCT01902433|"~     The purpose of this study is to compare the changes in pain and self-perceived function~     between two different treatments for Achilles tendinopathy: the Astym® protocol (a form of~     soft tissue mobilization using instruments) and a specific exercise protocol that involves~     strengthening the calf and Achilles tendon. Astym® (A-stim) is not an acronym, but rather~     stands for A Stimulation of the body's healing response, describing the physiologic process~     which occurs with Astym treatment. Astym is the trademark name of a non-invasive treatment~     where instruments are applied topically to locate unhealthy soft tissue, and to transfer mild~     to moderate pressure to the underlying soft tissue structures. The aim of Astym treatment is~     to eliminate scar tissue and stimulate tissue regeneration. Both the principal investigator~     and co-investigator have been trained and certified in administering the Astym treatment. The~     specific exercise protocol will involve exercises that strengthen the Achilles and calf~     through eccentric exercise. Eccentric exercise is a form of exercise where the benefit comes~     from applying a controlled lengthening stress to the muscle and tendon.~   "
127204|NCT01902420|"~     Acromegaly is a rare disease caused by growth hormone (GH) secreting pituitary adenoma in~     more than 95% of cases. Acromegaly can be seen sporadically or may be associated with a~     variety of genetic syndromes such as Multiple Endocrine Neoplasia Type 1, Carney Complex,~     familial isolated pituitary adenoma (FIPA) and Mc-Cune Albright Syndrome. The accompanying~     features of these syndromes and family history are helpful in the differential diagnosis.~     Aryl hydrocarbon receptor (AHR)-interacting protein (AIP) gene mutations can be seen~     sporadically as well as in FIPA. But the prescience of the presence of AIP mutation is~     limited by positive family history and early-onset of acromegaly. Furthermore, the~     probability of the patient to be the index case of the family should not be ignored.~      Screening for AIP gene mutation is recommended in patients with pituitary adenomas of~     childhood-onset, GH or prolactin secreting tumors who are diagnosed before the age of 30~     years and positive family history in two or more family members according to present evidence~     in the literature. It is also known that AIP mutation is usually associated with more~     aggressive clinical behavior due to unclarified reasons.~      The prevalence of AIP mutation in Turkish population and types of mutations have not been~     defined previously. The primary aim of the present study is to define the AIP gene mutation~     prevalence and the relation with clinical and tumour behaviour in a subgroup of Turkish~     acromegalic patients. If AIP gene mutation is detected in some patients, it will be possible~     to screen the family of the patient for the presence of AIP mutation or at least for the~     presence of pituitary adenoma.~      Acromegalic patients who are followed in Erciyes University Medical School Department of~     Endocrinology will be enrolled into the study. After DNA isolation, each exon of AIP gene~     including splicing points will be reproduced by polymerase chain reaction (PCR) and will be~     analyzed for the presence of mutation by sequence analysis. The cases will be analyzed~     further in means of clinical features according to presence of AIP gene mutation.~      The prevalence of AIP gene mutation, clinical reflection of presence of AIP mutation will be~     determined and genetic consultation will be given to the carriers of AIP gene mutation at the~     end of the study.~   "
127205|NCT01902407|"~     The purpose of this research study is to develop a way of predicting with computers how~     surgery on the airway will affect night time breathing called Obstructive Sleep Apnea (OSA)~     in children with Down Syndrome.~      Subjects will be in the research study for approximately a year. Participation in this~     research study will involves a screening visit and 1 overnight sleep study (PSG) for research~     purposes that will be done before airway surgery. During the research sleep study, a~     measurement will be taken for airway resistance. A research measurement for airway resistance~     will also be done during the clinical sleep MRI. The airway resistance measurement will take~     about 10 minutes and is done during sleep. The airway resistance measurement is called~     critical closing pressure (Pcrit).~   "
127206|NCT01902394|"~     The purpose of this study is to determine if substituting whole grains for refined grains in~     the diets of healthy adults over a period of 6 weeks alters the composition of the bacteria~     in the gut, and has beneficial effects on immune function, digestive health, cardiovascular~     health, regulation of body weight and composition, and vitamin K status.~      The investigators hypothesize that whole grain consumption over a period of 6 weeks will~     alter the gut microflora toward a more beneficial bacterial profile, improve the immune~     response while reducing oxidative stress and inflammatory markers, have favorable effects on~     factors influencing the regulation of body weight and composition,increase bacterial vitamin~     K synthesis, and beneficially effect surrogate markers of cholesterol synthesis/absorption,~     vitamin D concentrations, and whole genome DNA methylation patterns. In statin users it is~     hypothesized that, consumption of whole grains will alter statin pharmacokinetics by~     decreasing rate of statin absorption, resulting in more sustained plasma concentrations.~   "
127207|NCT01902381|"~     This pilot clinical trial studies 6, 8-bis (benzylthio) octanoic acid (CPI-613) in treating~     patients with myelodysplastic syndromes who failed previous therapy. Sometimes when~     chemotherapy or biological therapy is given, it does not stop the growth of tumor cells. The~     tumor is said to be resistant to treatment. 6, 8-bis (benzylthio) octanoic acid may interfere~     with the growth of tumor cells and may be an effective treatment for myelodysplastic~     syndromes that did not respond to previous therapy.~   "
127208|NCT01902368|"~     The purpose of this study is to see if it makes sense to test people for celiac disease who~     have a first or second degree relative (parent, sibling, child, grandparent, aunt or uncle)~     with celiac disease. The investigators will check to see what differences there are in the~     health and quality of life between those who know they have celiac disease and start the~     gluten free diet and those who do not.~   "
127209|NCT01902355|"~     The purpose of this study is to compare two needle insertion techniques(Seldinger vs.~     modified Seldinger technique) on success rate and complications during central venous~     catheterization.~   "
127210|NCT01902342|"~     Investigate genetic variability of CES1 gene on pharmacokinetics of oseltamivir in healthy~     Korean volunteers.~   "
127211|NCT01902329|"~     This study will examine the safety profile of vadastuximab talirine (SGN-CD33A) administered~     as a single agent and in combination with a hypomethylating agent (HMA). The main purpose of~     the study is to find the maximum tolerated dose (MTD, which is the highest dose that does not~     cause unacceptable side effects) of SGN-CD33A in patients with acute myeloid leukemia (AML).~     The MTD will be determined by observing the dose-limiting toxicities (the side effects that~     prevent further increases in dose) of SGN-CD33A. In addition, the pharmacokinetic profile and~     anti-leukemia activity of SGN-CD33A will be assessed.~   "
127212|NCT01902316|"~     Although diabetes has been controlled since insulin became available, it is still considered~     incurable and poses serious threats to human health. Reports have suggested that the~     hyperglycemic condition of patients with diabetes mellitus may be greatly alleviated or even~     reversed if it could be controlled at an early stage of diabetes. Thus, early detection and~     diagnosis of diabetes and prediabetes are become increasingly important in the treatment and~     prevention of diabetes. Diabetes mellitus is currently diagnosed by recurrent or persistent~     hyperglycemia. In an effort to identify novel biomarkers for diabetes, research has shown~     that neither plasma glucose nor glycated hemoglobin (HbA1c) levels are unable to be used in~     the early detection of diabetes. In this work, the investigators have found 8 biomarker~     candidates by developing a standard-free, label-free MS-based proteomics method based on~     standard protein (human serum albumin, the highest abundance protein in human plasma) model~     in vitro. Then, the investigators wanted to verify these biomarker candidates by clinical~     plasma samples to see if there is significant quantitative difference between normal people~     and diabetes patients.~   "
127213|NCT01902303|"~     The purpose of this study is to determine if a new drug treatment is effective to block the~     development of a cold sore lesion following Ultra Violet (UV) exposure.~   "
127214|NCT01902290|"~     The purpose of this study is to determine if brodalumab (AMG 827) is safe and effective~     compared to placebo as measured by change in Asthma Control Questionnaire (ACQ) composite~     scores.~   "
127588|NCT01897363|"~     This project will study whether infants with Prader-Willi Syndrome experience low blood~     sugars after short periods of fasting. This study will also evaluate metabolic markers in the~     blood to determine if infants with Prader-Willi Syndrome process energy differently than~     other children during fasting.~   "
127215|NCT01902277|"~     ICU delirium negatively impacts on patient outcomes, as well as on resources and clinical~     workflow of the ICU. Effective healthcare resource planning requires reliable (i.e.,~     multicentre) data that can inform on both of these.~      The purpose of this study was to determine the impact of ICU delirium in terms of both~     patients and beds. The study was carried out prospectively, over a one-week period, at adult~     ICUs comprising the Norfolk, Suffolk, and Cambridgeshire Critical Care Network (NSC CCN).~   "
127216|NCT01902264|"~     The objective of this study is to compare the red blood cell (RBC) and plasma concentrations~     of folate in subjects treated with drospirenone (DRSP)/ethinyl estradiol (EE) plus~     levomefolate calcium (L-5-MTHF) at 24 weeks with respect to basal determination.~      Increased intake of folic acid (synthetic form of the naturally occurring B-vitamin) before~     and in the first few weeks of pregnancy has been shown to reduce certain types of birth~     defects. This is important for women who may become pregnant following discontinuation of~     oral contraception. Information about any side effects that may occur will also be collected.~   "
127217|NCT01902251|"~     A multiple dose relative bioavailability study in patients with prostate cancer comparing a~     capsule and a tablet formulation of enzalutamide.~   "
127218|NCT01902238|"~     The present study evaluate the safety and efficacy of EUS-guided ethanol-lipiodol ablation~     for the treatment of pancreatic NET~   "
127219|NCT01902225|"~     This a multi-center, single arm, open-label, Phase I dose-finding and preliminary efficacy~     study of the combination of the histone deacetylase inhibitor romidepsin (Istodax®) in~     combination with doxorubicin HCl liposomal (Doxil®) for adult patients with relapsed or~     refractory cutaneous T-cell lymphoma after at least 2 lines of skin-directed therapy or one~     prior line of systemic therapy. Patients will be treated with Doxil 20mg/m2 on day 1 and~     romidepsin 8-14mg/m2 on days 1, 8 and 15, every 28 days, until 2 cycles beyond the best~     response, 8 cycles, disease progression or intolerability whichever comes first. Importanly,~     doxil is administered prior to romidepsin on day1 of each cycle. Patients will be followed~     until disease progression or death whichever comes first.~   "
127220|NCT01902212|"~     The objective of this study is to capture gastrointestinal tolerance (GI) information on a~     nutrient dense oral nutritional supplement (ONS) in healthy elderly subjects.~   "
127221|NCT01902199|"~     A randomized control trial evaluating a novel smoking cessation intervention in individuals~     at a an inpatient clinic for clients with addiction and concurrent disorders. The~     intervention is based on cognitive bias modification, where participants are explicitly or~     implicitly trained to make avoidance movements by pushing a joystick in response to pictures~     of smoking, and as a result altering their cognitive biases towards smoking and tobacco~     dependence.~      Hypothesis: Participation in the experimental (tobacco-avoidance) condition will induce~     reduction of smoking, assessed as lower levels of carbon monoxide measured at baseline and 12~     week follow-up.~   "
127222|NCT01902186|"~     Given the high prevalence of bone alteration in the course of HIV infection or antiretroviral~     treatment and the favourable properties of raltegravir the investigators designed this pilot~     randomized and controlled study. Adult female HIV-positive patients on successful treatment~     with tenofovir/emtricitabine plus atazanavir plus ritonavir will be randomized either to~     continue such a regimen or to switch to raltegravir plus atazanavir plus ritonavir. Bone~     mineral density changes will be compared in the two groups at 48 weeks: the hypothesis is~     that removing tenofovir and using tenofovir will increase bone mineral density at 48 weeks.~   "
127223|NCT01902173|"~     This phase I/II trial studies the side effects and the best dose of Akt inhibitor GSK2141795~     when given together with dabrafenib and trametinib and to see how well they work in treating~     patients with stage IIIC-IV cancer. Akt inhibitor GSK2141795, dabrafenib, and trametinib may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving~     Akt inhibitor GSK2141795 with dabrafenib and trametinib may be a better treatment for cancer.~   "
127224|NCT01902160|"~     This phase I trial studies the side effects and best dose of temsirolimus when given together~     with brentuximab vedotin in treating patients with Hodgkin lymphoma that has returned or has~     not responded to treatment. Temsirolimus may stop the growth of cancer cells by blocking some~     of the enzymes needed for cell growth. Biological therapies, such as brentuximab vedotin, may~     stimulate the immune system in different ways and stop cancer cells from growing. Giving~     temsirolimus with brentuximab vedotin may work better in treating patients with Hodgkin~     lymphoma.~   "
127225|NCT01902147|"~     Recovery following general anesthesia and surgery is a complex issue confounded by the type~     of surgery, surgical care, inflammation, different anesthetic drugs and techniques, patient~     co-morbidities, and differing patient and clinician perceptions of what constitutes good~     recovery. In this observational study, quality of recovery and patient satisfaction will be~     measured using the Postoperative Quality Recovery Scale (PQRS). This tool includes six~     domains of recovery: physiological, nociceptive (pain and nausea), emotive (anxiety and~     depression), functional recovery (return of activities of daily living), self-assessed~     recovery, and cognitive recovery.~   "
127226|NCT01902134|"~     This study aims to evaluate the analgesic efficacy of single and repeated doses of fixed~     combination of dexketoprofen trometamol (DKP) and tramadol hydrochloride (TRAM) in comparison~     to the single agents (and placebo for the single dose phase only) Approximately 600 male and~     female patients presenting moderate to severe pain after an elective primary hip arthroplasty~     are eligible to be randomised provided that they experience moderate to severe pain on the~     day after surgery.~   "
127227|NCT01902121|"~     A Phase 1, open-label, randomized, crossover study in 36 healthy normal volunteers (HNVs) to~     evaluate the bioequivalence of TI Inhalation Powder delivered using the Gen2 Inhaler and~     administered as one 30 U cartridge versus a combination of one 10 U cartridge and one 20 U~     cartridge.~   "
127228|NCT01902108|"~     The objective of this prospective randomized double-blind study is to evaluate the added~     analgesic value of clonidine to the conventional local bupivacaine wound infiltration in~     posterior spine surgery.~   "
127384|NCT01900041|"~     Pantovigar - a high effective product designed primarily for the treatment of diffuse hair~     loss in women as well as for the treatment of damaged hair, in the combined therapy can be~     successfully applied in other types of alopecia.~      The purpose of this study is to evaluate efficacy and tolerability of combination therapy~     Pantovigar plus 2% minoxidil vs 2% minoxidil. To collect tolerability data for combined~     treatment Pantovigar plus 2% Minoxidil course therapy.~   "
127229|NCT01902095|"~     Dental plaque, known as dental biofilm, is implicated as the primary etiological agent~     responsible for oral inflammatory diseases. Matured form of dental plaque plays a major role~     in the pathogenicity of gingivitis; if not managed in early stages it results in a cascade of~     events leading to the destruction of periodontal tissues.~      Effective plaque control techniques have been suggested that maintain dental biofilm at~     levels compatible with oral health and is the cornerstone for all preventive strategies to~     control oral diseases particularly gingivitis. To clean teeth and ensure effective plaque~     control, different mechanical means have been in use since centuries. However because of an~     inadequacy in plaque removal, different antimicrobial and antiplaque agents have been~     introduced in oral-care products.~      The use of dentifrices has been recommended over the years as the ultimate way of preventing~     the incidence of oral diseases. Dentifrices have the anti-plaque and the anti-gingivitis~     capabilities due to their composition. Toothpastes and to a lesser extent toothpowders are~     common oral-care products used to eliminate plaque and other deposits from tooth surfaces.~     Existent literature has focused more on toothpaste and mouth rinse and derelicts toothpowder~     despite its difference owing to the absence of humectants. With the intention to advance the~     knowledge on this issue as well as close the research gap, this study was conducted to~     evaluate the efficacy of toothpowder in alleviating gingivitis, controlling dental plaque,~     and inhibiting extrinsic stains.~      A single-blind, parallel arm randomized controlled trial (RCT) evaluated the efficacy of~     toothpowder against toothpaste through oral hygiene parameters of plaque and stain deposits~     on teeth and gingival inflammation. Plaque Index, Lobene Stain Index and Gingival Index were~     used as measures of oral hygiene.~      The current RCT revealed that toothpowder and toothpaste were equally effective in both~     treatment and control groups from clinical perspective however toothpowder showed a~     statistically significant effectiveness as compared to toothpaste. Toothpowder, composed of~     calcium carbonate and essential oils, has demonstrated to be statistically more effective~     than toothpaste in controlling extrinsic dental staining, dental plaque and gingival~     inflammation.~   "
127230|NCT01902082|"~     Currently, there is no proven effective pharmacologic treatment available for patients with~     the acute respiratory distress syndrome (ARDS). Mesenchymal stem cells have been shown to be~     effective in treating several inflammatory diseases. The main purpose of this study is to~     assess the safety of allogeneic adipose-derived mesenchymal stem cells in patients with ARDS.~   "
127231|NCT01902069|"~     The aims of this project are to:~        1. Determine if 3-weeks dietary supplementation with NOPE-EGCG (PhosphoLEANtm, 85mg~          NOPE+50mg EGCG per capsule) versus a placebo will improve performance on impulsivity,~          go/no-go tasks and negative outcome learning in heavy drinkers.~        2. Evaluate whether supplementation with NOPE-EGCG versus placebo results in reductions in~          alcohol consumption.~        3. Preliminary data in the rodent model suggests that rats treated with OEA shift~          preference for lower fat test stimuli. In aim 3 we will Determine if 3-weeks of~          supplementation with PhosphoLEAN shifts fat preference towards lower fat test puddings.~   "
127232|NCT01902056|"~     The purpose of this study is to compare the effect on soft tissue thickness of placing either~     a single or double layer of acellular dermal matrix simultaneous with dental implant~     placement. The hypothesis is that 2 layers of acellular dermal matrix will produce thicker~     tissues that one layer.~   "
127233|NCT01902043|"~     Diabetes, one of the most prevalent chronic disease (~ 9% worldwide), represents a major~     public health burden in terms of morbidity, disability and mortality. Caring for patients~     with diabetes requires effective collaboration between healthcare providers, teamwork,~     self-management education and use of evidence-based medicine. However, these processes of~     care are complex and often suboptimal. Improving quality of diabetes care is thus needed to~     reduce the health and societal burden of this disease.~      In the canton of Vaud, a state in Switzerland with more than 700,000 inhabitants, a recent~     population-based study has shown that the prevalence of diabetes was around 7%. Data on the~     quality of diabetes care is scarce and quality of care data are still infrequently and~     unsystematically collected in Switzerland. In addition, when data are available, they focus~     on intermediate outcomes as well as clinical and biological cardiovascular risk factors.~     Population-based data on patient-reported outcomes are not considered.~      In 2010, the Public Health Department of the canton of Vaud initiated the development of a~     regional diabetes program entitled Programme cantonal Diabète (PcD). It aimed both at~     decreasing the incidence of diabetes and improving care for patients with diabetes.~      To tailor the program to the healthcare needs of patients and healthcare professionals~     involved in diabetes care, an exploratory study using qualitative methods was conducted in~     2010. This was followed by a population-based survey conducted in fall 2011 and summer 2012.~     The objectives of the survey were to characterize patients with diabetes and assess the~     quality of the care they received. In addition, the results of the survey were used to help~     targeting unmet needs and possible areas of improvements, and constituted the patients'~     baseline measurement for the evaluation of the PcD.~      The CoDiab-VD cohort emerged from that initial project; its specific objectives were 1) to~     follow over time the quality of diabetes care, 2) to explore topics that the PcD needed for~     its development, 3) to assess the impact of the PcD on the care of patients with diabetes,~     and 4) to evaluate the coverage of the PcD in the canton of Vaud.~   "
127234|NCT01902030|"~     Although being a frequent and lethal complication in patients (pts) with hematologic~     malignancies, diagnosing invasive aspergillosis (IA) still remains a difficult issue as~     culture-based methods show low sensitivity especially under the current clinical practice of~     antifungal prophylaxis or rapid antifungal therapy. In certain clinical settings, performing~     biopsies for identification of the underlying infectious organism becomes important. However,~     as culture-based methods only yield results in a minority of patients, using~     non-culture-based methods like Aspergillus specific polymerase chain reaction (PCR) for~     detection of IA directly in clinical specimens is becoming increasingly important and might~     help to characterize the causative pathogen.~      Therefore the performance of an established Aspergillus-specific nested PCR in biopsies,~     re-section material or pleural effusions is evaluated.~   "
127235|NCT01902017|"~     Injured joints, especially at the elbow, are at risk for permanent motion loss, also known as~     joint contractures. Joint contractures limit the function of an elbow and are a recognized~     complication that occurs often after a traumatic injury. The benefits of early motion after~     injury has helped in preventing joint contractures but there are still several patients that~     develop debilitating joint contractures. Current research suggests that mast cells, which are~     found in the joint, are key in causing joint contractures. Research has been done using a~     medication called Ketotifen. Ketotifen has been linked to stabilizing mast cells and~     preventing the joint contracture. It is hoped that short-term use of this medication after an~     injury will prevent the contracture from occurring.~   "
127236|NCT01902004|"~     The proposed project will evaluate the role of neuroimaging biomarkers of brain aging (i.e.,~     neurodegenerative and vascular brain changes) and mild cognitive impairment in the patterns~     of treatment response to memantine combined with escitalopram compared to escitalopram and~     placebo.~   "
127264|NCT01901614|"~     The purpose of this study is to determine if a new procedure, called laser-assisted lamellar~     anterior keratoplasty (LALAK), can achieve the same level of vision with a lower risk of~     potential complications after surgery compared to another corneal transplant procedure. The~     current procedure is called Intralase-enabled keratoplasty (IEK) and replaces the entire~     cornea.~      The LALAK procedure involves transplanting only the top layers of the cornea instead of the~     entire cornea. Only one eye will have this experimental procedure performed. If both eyes~     need to have surgery your doctor will help you decide on the best non-study option for your~     other eye.~   "
139030|NCT01747525|"~     The primary objective of this study is to characterize coronary artery blockages as~     determined by the LipiScan combined NIRS-IVUS catheter using multi-vessel imaging.~   "
127237|NCT01901991|"~     Each year the Danish mammography-screening programme identifies a large number of patients~     with small non-palpable breast cancers or precancerous lesions. The majority of these~     patients are suitable for breast conserving surgery (BCS). The object of BCS is to remove the~     suspicious lesion completely without removing excess healthy breast tissue. To obtain this~     accurate lesion localization is essential.~      Until today the standard procedure in Denmark has been wire guided localization (WGL).~     Although the method has been utilized for a number of years it has several disadvantages.~     Often inaccurate lesion localization leads to incomplete lesion removal (positive margin) and~     subsequently reoperation. It can postpone the additional systemic treatment, offered after~     the operation. Other disadvantages are poor cosmetic outcome and inconvenient planning for~     the patient and the departments involved. The wire needs to be placed on the day of the~     operation, which decreases the flexibility of the procedure.~      The purpose of this study is to test a new method named radioactive seed localization (RSL).~     The method uses a small titanium seed containing radioactive iodine. It will be placed in the~     centre of the lesion, and during the operation, the surgeon can locate it with a handheld~     gamma probe. The seed can be placed a few days in advance, which means a more flexible course~     of treatment. The method seems promising with regards to reoperation rates, but it needs~     further testing.~      Hypothesis:~      RSL is a more accurate method, for localization of nonpalpable breast lesions, than WGL.~     Using RSL obtains, to a great extent, adequate negative margins, resulting in a reduced~     number of re-operations.~      The study will be performed as a randomised clinical trial, where the two methods will be~     compared to each other. The trial will be performed at the department of breast surgery at~     Rigshospitalet and include patients with nonpalpable breast lesions. Besides reoperation~     rates, duration of the surgical procedure and the amount of removed breast tissue will be~     compared.~   "
127238|NCT01901978|"~     The purpose of this study is to investigate the changes in subcutaneous adipocyte size,~     number and gene expression after weight loss and to assess whether those changes contribute~     to decreases in ectopic fat accumulation and insulin resistance in women between ages of~     16-32.~   "
127239|NCT01901965|"~     The main aims of the study are (1) to examine the impact of contralateral strength training~     on the quadriceps muscle function after ACL surgery and (2) to compare the magnitude of~     cross-education induced by NMES versus eccentric strength training.~   "
127240|NCT01901952|"~     The primary aim of the LIFE study is to compare low-income African American diabetes patients~     in a lifestyle intervention group with those in a standard of care control group on change in~     glycemic control at 12-months. We hypothesize that, on average, participants in the~     intervention group will achieve greater glycemic control at 12-months relative to their~     baseline A1c, than those in the control group.~   "
127241|NCT01901939|"~     The proposed preliminary study from this interdisciplinary team will provide important~     information about the feasibility and safety of bedside low intensity pedaling exercise~     during hospitalization. The findings from this study are essential to develop high-value,~     effective treatments that can be used by any hospital setting throughout the country. The~     program that investigators are proposing may provide important changes in how disability can~     be prevented in elderly patients who are hospitalized because of an acute illness.~   "
127242|NCT01901926|"~     The purpose of this study is to determine the effects of non surgical periodontal treatment~     on glycemic control in type II diabetics.~   "
127243|NCT01901913|"~     The MDLAP (MD-Logic Artificial Pancreas)system is as an automatic system to regulate glucose~     levels by delivery of insulin operable in clinical trial settings. The safety of the system~     was proved in previous inpatient and outpatient trials in large number of patients. In the~     current study we aim to optimize post-prandial closed-loop glycemic control by developing an~     automated MD-bolus calculator and to evaluate its safety and efficacy in controlling~     postprandial blood glucose when used together with the MD-Logic artificial pancreas system in~     type 1 diabetes patients.~      The study will consist of a pilot study with two segments and a main study segment. The aim~     of each segment is detailed below:~        1. Pilot Study - Segment 1 - Hybrid meal bolus ratio The aim of this segment is to evaluate~          the efficacy and safety of different pre-meal bolus dosing compared to full closed-loop~          operation with no meal announcement.~        2. Pilot Study - Segment 2 - Insulin dosing during meal In this segment we would like to~          test the optimal distribution of insulin delivery during the meal.~        3. Main study - Segment 3 - Automatic bolus calculator In this main segment of the study we~          will use the results and conclusions from the previous two pilot segments to develop the~          MD-Bolus Calculator for closed-loop control use. The safety and efficacy of this~          automated insulin bolus calculator will be tested in a randomized cross-over study that~          will compare postprandial glycemic control under MDLAP with and without the use of the~          MD-Bolus Calculator.~   "
127244|NCT01901887|"~     The BRAVO study seeks to determine if dietary supplementation with omega-3 highly unsaturated~     fatty acids (omega-3 HUFAs) reduces the risk for serious suicidal behaviors, suicidal~     thinking, negative emotions, and symptoms associated with suicide risk, in a Veteran and~     non-Veteran population that is at risk for suicidal behaviors. This study seeks to evaluate~     the efficacy of omega-3 HUFAs among a representative population of US Veterans and~     non-Veterans already receiving appropriate medical care so that if successful, these results~     can be readily applied to broader populations in the US.~   "
127245|NCT01901861|"~     study hypothesis to examine the acute effects on glycaemia and islet hormone secretion of~     increased levels of endogenous GLP-1 and GIP on islet cell function in men with type 2~     diabetes. To this purpose, a standardized mixed meal test will be ingested with or without~     concomitant administration of sitagliptin (100mg).~   "
127246|NCT01901848|"~     Posttraumatic stress disorder (PTSD) and cigarette smoking are both associated with~     significant impairment in Veterans and cost to the Veterans' Affairs (VA) system. Though~     research suggests smoking is linked with PTSD symptoms, existing smoking cessation treatments~     targeting PTSD smokers do not include PTSD treatment. The purpose of this study is to examine~     a treatment that combines evidence based treatment for PTSD (cognitive processing therapy, or~     CPT) with smoking cessation treatment for PTSD and a mobile text messaging program. The study~     objectives are to evaluate feasibility of the treatment and to examine effectiveness of CPT~     and smoking cessation treatment combined compared to smoking cessation treatment without CPT.~     Fifty Veteran smokers with PTSD will participate in fourteen study sessions, ending with the~     final follow-up session six months after the scheduled quit date.~   "
127247|NCT01901835|"~     This randomized clinical trial studies media diversion in improving quality of life in~     patients with recurrent gynecologic cancers receiving chemotherapy. Media diversion may~     improve mood and quality of life in patients having cancer treatment.~   "
127248|NCT01901822|"~     The hypothesis of this study is that coronally positioned tunnel with acellular dermal matrix~     using a continuous sling suture to secure both the graft and the flap will result in better~     percent root coverage compared to the continuous sling suturing technique to secure the graft~     and the flap separately.~   "
127249|NCT01901809|"~     Heart Failure with preserved Ejection Fraction (HFPEF) accounts for 40-50% of all heart~     failure patients with a frequency of hospital admissions for acute decompensation and short~     and long term mortality similar to patients with heart failure with reduced ejection fraction~     (HFREF). Patients with HFPEF are often preload dependent and despite admission to the~     hospital for acute decompensated heart failure (ADHF), are typically difficult to diurese due~     to the development of acute kidney injury. No studies have been performed evaluating~     treatment strategies for these patients. The investigators hypothesize that changing the~     method of diuresis and/or the addition of low-dose dopamine for the treatment of ADHF in~     patients with HFPEF will reduce renal injury, resulting in a shorter length of stay, and~     decrease hospital readmissions over the ensuing year. This trial will randomize patients to~     either bolus or continuous infusion furosemide and then to either dopamine or no dopamine.~     The primary endpoint will be renal function at 72 hours as measured by change in Glomerular~     Filtration Rate (GFR). Secondary endpoints for readmission, functional capacity, quality of~     life, and amount of diuresis will also be collected.~   "
127250|NCT01901796|"~     We hypothesize that the intervention will: (1) offer a feasible approach for providing mental~     healthcare to pregnant women and have a high level of acceptability by pregnant women and~     healthcare providers; (2) reduce symptoms of depression, stress, anxiety, and parenting~     stress; improve parenting competence, coping, and relationship adjustment compared to usual~     care; and (3) reduce the risk of poor maternal-infant attachment. As such, this early~     intervention holds promise for reducing maternal mental health morbidity and its negative~     influences on infants, children, and families.~   "
127251|NCT01901783|"~     This study is designed to compare the clinical and histologic results of ridge augmentation~     with and without primary closure over the barrier membrane. The hypothesis is that there will~     be no difference in crestal ridge width between the two groups.~   "
127252|NCT01901770|"~     This clinical trial studies an educational intervention for parents and providers in~     increasing human papillomavirus (HPV) vaccination rates in younger girls in Ohio Appalachia.~     Educational interventions may be effective in increasing the number of participants whose~     daughters receive HPV vaccination.~   "
127253|NCT01901757|"~     To investigate the effect of food in healthy male volunteers who receive HCP1201 tablet in~     fed versus fasted condition~   "
127254|NCT01901744|"~     The study evaluates contrast sensitivity in older children following surgery for lamellar and~     posterior subcapsular cataracts. Often, pediatric surgeons tend to delay surgery in these~     children who present beyond the amblyogenic age group. These cataracts are often compatible~     with reasonable visual acuity and therefore some surgeons prefer to wait for surgery, whereas~     others tend to operate.~      The study evaluates improvement in contrast sensitivity at different spatial frequencies~     following cataract surgery for lamellar and posterior subcapsular cataracts in older~     children.~   "
127255|NCT01901731|"~     The aim of this study is to identify whether the treatment of pelvic venous reflux (pelvic~     coil embolisaton) in females with leg varicose veins, who have a proven contribution to their~     leg varicose veins from pelvic reflux, have a reduction in recurrence after varicose vein~     surgery.~   "
127256|NCT01901718|"~     Chronic pain patients who experience breakthrough pain in the background of controlled~     persistent pain with opioids will be followed for 3 months in order to assess the safety and~     titration trends in the clinical practice setting of a novel fentanyl sublingual spray~     (Subsys™) for the treatment of breakthrough pain.~   "
127257|NCT01901705|"~     Psoriasis is a common, chronic skin disease for which only remissive, as opposed to curative,~     treatments are available. Traditional Chinese medicine is one of the most frequently chosen~     alternative therapies in China and Taiwan, and psoriasis has been treated for centuries with~     topical and oral herbal preparations. Topical indigo naturalis ointment has been reported to~     exhibit potential anti-psoriatic efficacy. The study objective is to investigate~     pharmacological effect and explore targeting mechanisms of Traditional Chinese Medicine (TCM)~     Indigo Naturalis topical ointment as a single treatment agent in Chinese subjects with mild~     to moderate plaque-type Psoriasis.~      This was a single site, randomized, double-blinded, placebo controlled study of topical~     indigo naturalis vs. vehicle alone (placebo) to treat mild to moderate plaque-type psoriasis~     during an 8-week period. Pharmacological effect will be evaluated by biomarker evaluation and~     clinical evaluation. The trial was conducted at the China Medical University Hospital (CMUH),~     Taichung, Taiwan. All patients provided written informed consent before inclusion in the~     study. The study protocol was approved by the institutional review board (IRB) of CMUH.~   "
127258|NCT01901692|"~     To evaluate and compare the efficacy and safety of sorafenib versus trans-arterial~     chemoembolization plus external beam radiation therapy in patients with hepatocellular~     carcinoma invading major intrahepatic vessels~   "
127259|NCT01901679|"~     The study plans to find out whether Celebrex may be potentially useful to decrease~     inflammation in fat tissues and thereby lower the production of substances such as estrogens~     that may increase the risk of developing breast cancer and lead to a poor outcome of the~     disease.~   "
127260|NCT01901666|"~     CML is a myeloproliferative disorder defined by the presence of the Philadelphia chromosome,~     which arises from the reciprocal translocation of genes on chromosomes 9 and 22.It is rare in~     childhood and accounts for 2-3% of all leukemias in childhood.~      BCR-ABL gene on Philadelphia chromosome results in a 210kd fused BCR-ABL protein with~     constitutive tyrosine kinase activity, and subsequent activation of cytoplasmic and nuclear~     signal transduction pathways including STAT, RAS, JUN, MYC, and phosphatidylinositol-3~     kinase. The ultimate result of such activation is the myeloid proliferation and~     differentiation and suppressed apoptosis.~      Children present with a higher WBC count, otherwise presentation is nearly identical to~     adults. Current treatment include tyrosine kinase inhibitors (TKI) and allogeneic stem cell~     transplant (SCT).Imatinibmesylate inhibits the tyrosine kinase (TK) activity of BCR-ABL1 and~     several related TKs, including c-kit and the platelet-derived growth factor receptor (PDGFR).~     Development of tyrosine kinase inhibitor (TKI) therapy has revolutionizedtreatment of CML.~     Imatinib or second generation TKIs (dasatinib or nilotinib) have become standard front-line~     therapy forchildren and adults with CML and are also important componentsof therapy for Ph+~     acute lymphoblastic leukemia (ALL).~      TKIs are administered orally and cause a number of side effects including fatigue,~     hypertension, rash, impaired wound healing, myelosuppression, and diarrhea . The overall~     toxicity of TKIs, while less life-threatening than conventional cytotoxic chemotherapy,~     nevertheless is common, and may require dose reduction.Recently, proposed endocrine-related~     side effects of these agents include alterations in thyroid function, bone metabolism, linear~     growth, gonadal function, fetal development, glucose metabolism and adrenal function.~      Growth impairment is one of the major adverse effect of long-term imatinib treatment in~     children with CML. Multiple case reports have demonstrated growth retardation in children~     onimatinib.Imatinibmesylate inhibits the TK activity of BCR-ABL1 and several related TKs,~     including c-kit and theplatelet-derived growth factor receptor (PDGFR). It isthe inhibition~     of TK activity at the non-BCR-ABL sites that couldbe the likely cause for the adverse effect~     on growth. Severalstudies in adults have suggested that inhibition of c-kit,c-fms, and PDGF~     receptors results in modulation of bone metabolism. Other reports are focusing on disturbance~     of the growth hormone (GH) axis as a mechanism for growth impairment. Receptor and non~     receptor TK is expressed at multiple levels in GH-IGF-1 axis including GHRH-R, GH-R and~     IGF-1R. Inhibition of TKs with TKI, at any one of these level, might result in growth~     impairment.~      Various studies are available to show that Imainib therapy may cause short stature in~     children on prolonged treatment but exact mechanism by which this occurs is still not clear.~     Further, no treatment modality has been tried so far, for short stature in these children.~      So, the purpose of this study is to study GH-IGF1 axis in these children and to administer GH~     therapy to GH deficienct children in remission.~   "
127261|NCT01901653|"~     The purpose of this study is to assess the safety and tolerability of SC16LD6.5 at different~     dose levels in patients with small cell lung cancer whose cancer has progressed or recurred~     following standard chemotherapy. Once a safe and tolerable dose is determined, the~     anti-cancer activity of SC16LD6.5 will be assessed by measuring the extent of tumor~     shrinkage. SC16LD6.5 is an antibody-drug conjugate (ADC). The antibody (SC16) targets a~     protein that appears to be expressed on the surface of most small cell lung cancers that have~     been assessed using an immunohistochemical assay. The drug, D6.5, is a very potent form of~     chemotherapy, specifically a DNA-damaging agent, that is cell cycle independent. ADC's~     theoretically provide more precise delivery of chemotherapy to cancer cells, possibly~     improving effectiveness relative to toxicities.~   "
127262|NCT01901640|"~     Phase : Phase III Indication : Erectile Dysfunction Study Design : open-label, fixed dose,~     6-month extension study (parent study : DA8159_EDD_III)~   "
127263|NCT01901627|"~     A multicenter registry to explore the clinical outcome of Chinese adult patients with active~     Ankylosing Spondylitis *AS* treated with adalimumab,prescribed according to the local~     label,in the real world practice~   "
127265|NCT01901601|"~     The purpose of this protocol is to compare and develop new surgical technique of~     partial-thickness corneal transplantation for treating corneal opacity. A newly developed~     technique, dovetail laser-assisted lamellar anterior keratoplasty (LALAK), will be tested~     and compared with standard full-thickness corneal transplantation, Intralase-enabled~     keratoplasty (IEK). The new LALAK technique replaces only the front portion of the cornea and~     does not have the risks associated with conventional IEK. Additionally, optical coherence~     tomography (OCT) will be used to guide the depth of the graft and donor dissections.~      The data will be analyzed to understand whether the new technique (LALAK) can repeatedly~     achieve good visual outcomes with lower risk from the operation compared to the visual~     outcomes and risk associated with the current standard of care, IEK.~   "
127266|NCT01901588|"~     This study is trying to see if using precedex pre-operatively prevents emergence delirium in~     pediatric (ages 1-7) patients undergoing strabismus surgery.~   "
127267|NCT01901575|"~     Determine effects of remifentanil conscious sedation in patients undergoing~     Electrophysiological (EP) studies for the ablation of idiopathic ventricular tachycardia~     and/or persistent frequent premature ventricular contractions (PVCs) of non-ischemic origin~   "
127268|NCT01901562|"~     In this prospective clinical trial, patients who sign an approved informed consent for~     ductoscopy to assess etiology of Pathologic nipple discharge (PND) will be enrolled in the~     study. Consented patients who have been diagnosed with a solitary papilloma within the~     discharging duct will be recruited to have interventional ductoscopy.~      Patients who are identified ductoscopically with a solitary non-sessile papilloma will~     undergo an attempted ductoscopic papillomectomy (DP). Patients with ductoscopic findings~     other than single non-sessile papilloma will undergo standard ductoscopically guided~     microductectomy. The investigators will investigate whether the ductoscopic basket can be~     used as a safe endoscopic extraction instrument without adverse events. Histopathological~     evaluation will be performed to confirm the ductoscopic diagnosis and to determine the~     existence of any malignant tissue.~   "
127269|NCT01901549|"~     This study is aimed to evaluate the effect of renal denervation to decreasing blood pressure~     and left ventricle remodeling progression in patients after acute coronary syndrome.~   "
127270|NCT01901536|"~     This is a research study to evaluate the effectiveness of the Family Foundations program and~     to better understand how families cope with having a new baby. The research questions~     include: What is the effectiveness of the Family Foundations program? How do families cope~     with having a new baby?~   "
127271|NCT01901523|"~     Clinical research, like all science, is self-correcting, with errors detected by the~     scientific community and communicated to the publishing journals, which then relay the~     information (and its resolution) to its readers. If this relaying process fails, science~     grinds to a halt. In this study we are testing its integrity.~   "
127272|NCT01901510|"~     This study first is designed to see what dose of indigo carmine ingested orally mixed with~     the standard colonoscopy prep is needed to provide adequate staining of the right colon. It~     then will use this adequate staining concentration of Indigo Carmine to study whether this~     dye will increase the detection of polyps during colonoscopy.~   "
127273|NCT01901497|"~     The purpose of the study is to compare the pharmacokinetics of nebulized amikacin~     administered with three vibrating mesh nebulizers coupled with a single limb circuit bilevel~     ventilator in healthy volunteers. Following our previous in vitro study, our hypotheses are~     that the pharmacokinetics varies among the devices tested and that a most efficient device~     can be identified.~   "
127274|NCT01901484|"~     This study is about intestinal schistosomiasis, commonly known as bilharzia, in children aged~     1-5 years along Lake Victoria shoreline.The children will be screened for S. mansoni and the~     effects of the disease will be assessed.Children found positive with S. mansoni will be~     treated with praziquantel and followed up for a year.~   "
127275|NCT01901471|"~     The size of the acute myocardial infarction (AMI) is related to ischemia and injury induced~     by tissue reperfusion. These reperfusion's injuries can be reduced by injection of~     cyclosporin A (CsA) at the time of reperfusion. This post-conditioning reduces the final~     infarct size 20 to 40%. This has been demonstrated in STEMI patients non-complicated by~     cardiogenic shock. Early revascularization in the AMI complicated by cardiogenic shock~     improves short-term and long term survival by reducing the size of the myocardial infarction.~     The hypothesis of this study is that the administration of Cyclosporin A to these patients,~     in addition to mechanical reperfusion, is likely to reduce the severity of the multi-organ~     failure associated with the cardiogenic shock and improve clinical outcome.~   "
127276|NCT01901458|"~     The study will determine the advantage of the Spectra Optia® IDL set compared to the standard~     collection set for collection of peripheral blood progenitor cells using the Spectra Optia®~     apheresis system. The study will assess the reduction of apheresis time to obtain the~     required amount of hematopoietic progenitor cells.~   "
127277|NCT01901445|"~     The purpose of this study is to determine if the quality of life in children and adolescents~     diagnosed with chronic functional constipation improves after educational activity in focus~     group composed by these patients' mothers.~   "
127304|NCT01901094|"~     This randomized phase III trial studies axillary lymph node dissection to see how well it~     works compared to axillary radiation therapy in treating patients with node-positive breast~     cancer treated with neoadjuvant chemotherapy followed by surgery. Lymph node dissection may~     remove cancer cells that have spread to nearby lymph nodes in patients with breast cancer.~     Radiation therapy uses high-energy x-rays to kill tumor cells. This study will evaluate~     whether radiation therapy is as effective as lymph node dissection.~   "
127305|NCT01901081|"~     This study will evaluate the feasibility of using implanted myoelectric sensors (IMES) to~     control an electromechanical prosthetic wrist and hand.~   "
127385|NCT01900028|"~     This is a 3-part study in patients with advanced solid tumours: Part A will assess the effect~     of itraconazole on the PK parameters of olaparib and will determine the effect of olaparib on~     the QT interval following single oral dosing; Part B will determine the effect of olaparib on~     the QT Interval following multiple oral dosing; Part C will allow patients continued access~     to olaparib after the PK and QT phases and will provide for additional safety data~     collection. A total of 48 patients are planned to be enrolled; at least 42 evaluable patients~     will be required to complete the study. Patients will participate as a single cohort in all~     parts of the study.~   "
127278|NCT01901432|"~     This is a two-part, multicenter, open label, non-randomized, phase Ib/II study to assess the~     safety and tolerability, Maximum Tolerated Dose and preliminary efficacy of Givinostat in~     patients with JAK2V617F positive Polycythemia Vera. Part A is the dose finding part while~     Part B is assessing the preliminary efficacy. Patients will be enrolled either in Part A or~     Part B and transition from one part to the other is not allowed.~      Eligible patients for this study will have a confirmed diagnosis of Polycythemia Vera~     according to the revised World Health Organization criteria. Only if the enrolment in Part A~     is slow (i.e. < 5 patients enrolled in 3 months), eligibility for this part of the study may~     be expanded to all patients with chronic myeloproliferative neoplasms.~      Study therapy will be administered in 28 day cycles (4 weeks of treatment). Disease response~     will be evaluated according to the European LeukemiaNet criteria after 3 and 6 cycles (i.e.~     at weeks 12 and 24, respectively) of treatment with Givinostat for both parts of the study.~     All phlebotomies performed in the first 3 weeks of treatment will not be counted to assess~     the clinico-haematological response.~      The study will last up to a maximum of 24 weeks of treatment. However, after completion of~     the trial, all patients achieving clinical benefit will be allowed to continue treatment with~     Givinostat (at the same dose and schedule) in a long-term study.~      Safety will be monitored at each visit throughout the entire duration of the study. Treatment~     will be administered on an outpatient basis and patients will be followed regularly with~     physical and laboratory tests, as specified in the protocol; in case of hospitalization, the~     treatment will be continued or interrupted according to the Investigators' decision.~   "
127279|NCT01901419|"~     Hypothermic cardiopulmonary bypass results in peripheral vasoconstriction and heparin~     trapping. Hypoperfusion and ischemic-reperfusion injury are associated with systemic~     inflammatory response, while insufficient and delayed neutralization of heparin by protamine~     may contribute to more blood loss during rewarming stage.~      Nitroglycerin infusion, an NO-related vasodilator, is an established and effective treatment~     for unstable angina, myocardial infarction, congestive heart failure, and perioperative~     hemodynamic management for cardiac surgery. Therefore, we hypothesize that nitroglycerin~     infusion during rewarming corrects systemic ischemic stress and facilitates heparin~     neutralization in cardiac surgery.~   "
127280|NCT01901406|"~     Epiretinal membrane is common disease, affecting 5~10 % incidence over 60 years old~     population. It reduce visual acuity, cause metamorphopsia. In the past, vitrectomy and~     epiretinal membranectomy was indicated in patients with visual acuity less than 20/40, but~     nowadays with technical improvement and surgical instrument renovation, it seems to have been~     changed the surgical indication. Therefore, we plan to evaluate the changes of binocular~     visual acuity, aniseikonia in patients with epiretinal membrane.~   "
127281|NCT01901393|"~     The purpose of this study is to assess the efficacy of intravenous ibuprofen compared to~     ketorolac for the treatment of postoperative pain as measured by patient pain intensity~     (Visual Analog Scale, VAS)~   "
127282|NCT01901380|"~     Cow's milk allergy (CMA) is the most common food allergy in early childhood, with an~     estimated incidence ranging between 2% and 3% in infants and marginally lower in older~     children. It has been demonstrated that it could be a risk factor for the development of the~     functional gastrointestinal disorders in children. Intestinal microflora has been indicated~     as potential target for the management of CMA and FGDIs through the use of probiotics.~     Lactobacillus rhamnosus GG (LGG) is the most studied probiotic. Recently, it has been~     demonstrated that an extensively hydrolyzed casein formula remains hypoallergenic following~     the addition of LGG, satisfying both the American Academy of Pediatrics guidelines.~     Lactobacillus GG exerts several benefits when added to an extensively hydrolyzed casein~     formula (Nutramigen LGG), including decreased severity of atopic dermatitis, improved~     recovery of intestinal symptoms in infants with CMA-induced allergic colitis, and faster~     induction of tolerance in infants with CMA. The mechanisms of these effects are multiple and~     exerted at different levels: epithelium, immune system and enteric nervous system. Studies~     and meta-analyses showed that LGG increases treatment success in children with functional~     gastrointestinal disorders.~   "
127283|NCT01901367|"~     This randomized pilot phase II trial studies how well nutritional intervention and exercise~     intervention works in preventing metabolic syndrome in younger patients with acute~     lymphoblastic leukemia. Nutritional intervention may help weight loss and improve quality of~     life in patients with acute lymphoblastic leukemia. Exercise may help decrease feelings of~     being tired caused by cancer, may help improve strength, and may help build up lost muscle~     tissue. Nutritional intervention plus exercise intervention may be effective at preventing~     metabolic syndrome.~   "
127284|NCT01901354|"~     This study will compare two ventilator modes in mechanically ventilated patients with acute~     lung injury.~      Acute lung injury (ALI) is a condition in which the lungs are badly injured and are not able~     to absorb oxygen the way healthy lungs do. About 25% of patients who are ventilated get ALI.~     ALI causes 75,000 deaths in the US each year.~      Ventilators can be set to work in different ways, called modes. One mode, called ARDSNet,~     pumps a small amount of air into the patient's lungs and then most of the air is released~     prior to the next breath. Another mode, called Airway pressure release ventilation (APRV),~     keeps air in the lungs longer between breaths. Both of these modes are currently used at this~     hospital. The investigators think APRV may help patients with ALI, but we do not know for~     sure.~   "
127285|NCT01901341|"~     The purpose of this study is to evaluate the safety and efficacy of CB-5945 for the treatment~     of opioid-induced constipation (OIC) in adults taking opioid therapy for chronic non-cancer~     pain.~   "
127286|NCT01901328|"~     The purpose of this study is to evaluate the safety and efficacy of CB-5945 for the treatment~     of opioid-induced constipation (OIC)in adults taking opioid therapy for chronic non-cancer~     pain.~   "
127287|NCT01901315|"~     The purpose of this project is to compare the effectiveness between face-to-face~     consultations and consultations via videoconferencing among patients treated in the Institute~     of Psychiatry (IPq).~   "
127288|NCT01901302|"~     The purpose of this study is to evaluate the safety and efficacy of CB-5945 for the treatment~     of opioid-induced constipation (OIC) in adults taking opioid therapy for chronic non-cancer~     pain.~   "
127289|NCT01901289|"~     The Zilver® PTX® V Clinical Study is a post-market clinical trial required by the US FDA to~     provide continued evaluation of the safety and effectiveness of the Zilver PTX Drug-Eluting~     Peripheral Stent in treatment of narrowing of the femoropopliteal arteries.~   "
127290|NCT01901276|"~     The colonic microbiome is essential in human health and disease. Clostridium~     difficile-associated diarrhea (CDAD), a highly morbid form of infectious diarrhea, is caused~     by antibiotics which perturb the microbiome and allow C. difficile to proliferate. Proton~     pump inhibitors (PPIs) are powerful suppressors of gastric acid and among the most common~     medicines in the United States. Dozens of observational studies show that longterm PPI use is~     associated with CDAD. However, the mechanism by which PPIs cause CDAD is unknown. We believe~     that PPIs cause CDAD by inducing alterations in the human colonic microbiome. We will confirm~     or refute the hypothesized mechanism for the association between PPIs and CDAD using an~     unblinded, single-armed study design. We will use pyrosequencing of the hypervariable V4~     region of the bacterial 16S ribosomal subunit gene in human fecal samples to describe the~     colonic flora. We will collect fecal samples from volunteers before and after PPIs given for~     different durations and test the microbiome to determine 1) whether PPIs diminish overall~     diversity, 2) whether PPIs diminish relative abundance of Bacteroidetes, 3) whether increased~     duration of PPIs affects diversity, and 4) whether there is recovery of diversity after~     completing a defined course of PPIs. We believe that PPIs will cause a pattern of diminished~     overall microbiome diversity and reduced anaerobes — the same pattern seen after use of~     antibiotics. Furthermore, we believe that increased PPI duration will further diminish~     diversity and that the microbiome will return to pre-PPI levels of diversity after PPIs are~     stopped. These results will facilitate biologically-based clinical interventions to reduce~     rates of CDAD among patients who require acid suppression.~   "
127291|NCT01901263|"~     Cognitive and behavioral units (CBUs) have been created between 2008 and 2012 French National~     Alzheimer plan for the management of behavior problems of patients suffering from Alzheimer's~     disease or other related disorders and necessitating hospitalisation. This Alzheimer plan is~     promoting the evaluation of these units through the observation of the behavioral and~     psychological symptoms of dementia (BPSD) evolution. As these units are new, it appears~     important to assess their long-term impact on patients care.~   "
127292|NCT01901250|"~     The purposes of this study is to determine whether xylitol use in kindergarten school~     children in addition to oral health education, provision of tooth brush and fluoride paste,~     fluoride varnish and sealant treatment will reduce decay in the first permanent molars and~     other permanent teeth.~   "
127293|NCT01901237|"~     Adolescents and young adults who are living with cancer are not benefiting from the same~     age-appropriate physical and psychosocial care, as are children and older adults. As a~     result, their unique needs often go unmet or unaddressed. Studies have demonstrated that a~     lack of age-appropriate care may be responsible for a deceased quality of life. Studies have~     also shown that physical activity is able to reduce many of the negative side-effects linked~     to cancer and its treatment (e.g., nausea, vomiting, fatigue). A light form of physical~     activity that is both safe and manageable for cancer patients is yoga. The purpose of this~     study is to examine the achievability and safety of a light 7-week home/hospice-based Hatha~     yoga program (available on DVD) in the adolescent and young adult non-curative cancer~     population. This study will also examine the ability of yoga to reduce cancer related side~     effects.~   "
127294|NCT01901224|"~     The investigators are doing this research study to find out if taking Metformin improves~     walking ability in patients with peripheral arterial disease (PAD). In PAD the arteries~     (blood vessels) in the legs are narrowed because of the build up of plaque. The leg muscle~     can hurt in patients with PAD and this is usually described as a cramp or tiredness. This~     pain is called intermittent claudication. Metformin is an FDA approved medication for the~     treatment of diabetes. The investigators believe that Metformin may help your leg muscles~     work better.~      The investigators will enroll up to 100 subjects in order to find 60 subjects with PAD at~     Brigham and Women's Hospital (BWH).~   "
127295|NCT01901211|"~     As children with cerebral palsy (CP) become teenagers, they experience a decrease in their~     physical function and mobility. Decreased mobility leads to increased social isolation for~     the teens and impacts negatively on their quality of life. This loss of function is~     multifactorial, but poor physical fitness and muscle weakness secondary to disuse are~     significant contributors. Exercise video games are a novel approach to engage youth in~     physical exercise and social interaction with their peers. The objective of this study is to~     evaluate the impact of an exercise video gaming intervention to improve physical fitness and~     social wellbeing. Our over-arching research questions are whether exergames can provide~     health benefits (improved physical fitness) and improved social wellbeing in youth with CP.~   "
127296|NCT01901198|"~     This study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of~     Recombinant Human Serum Albumin/interferon alpha2a Fusion Protein single dose in Chinese~     healthy volunteers.~   "
127297|NCT01901185|"~     The purpose of this study is to assess the ability of people with rheumatoid arthritis (RA)~     or psoriatic arthritis (PsA) to use an experimental autoinjector to self inject etanercept~     (Enbrel®).~   "
127298|NCT01901172|"~     This multicenter, open-label study will evaluate the effect of posaconazole on the~     pharmacokinetics of RO5503781, the relative bioavailability of two new RO5503781~     formulations, and the effect of food on the pharmacokinetics of RO5503781 in patients with~     solid tumors.~   "
127299|NCT01901159|"~     This randomized, open-label, cross-over study will assess the bioavailability and safety of~     RO4995819 in healthy volunteers. Volunteers will receive two different formulations (tablet~     and capsule) of the study drug under fed and fasting conditions.~   "
127300|NCT01901146|"~     The purpose of this research study is to compare the effectiveness and safety of ABP 980~     against trastuzumab in women with early breast cancer.~   "
127301|NCT01901133|"~     This study will assess the influence of hepatic impairment on the pharmacokinetics, safety~     and tolerability of a single dose of MDV3100 in male subjects.~      The study will consist of two treatment arms. Arm A will assess the influence of mild hepatic~     impairment, and Arm B will assess the influence of moderate hepatic impairment. Data obtained~     from subjects with hepatic impairment will be compared to data from Body Mass Index (BMI) and~     age-matched subjects with normal hepatic function.~   "
127302|NCT01901120|"~     This study is to evaluate the safety and efficacy of long-term use of Betanis (generic name:~     mirabegron), and to determine the adherence to treatment with mirabegron.~   "
127303|NCT01901107|"~     The purpose of this survey is to evaluate the safety and efficacy of long-term use of Kiklin®~     Capsules in actual clinical settings.~   "
127306|NCT01901068|"~     A great number of different suture techniques and suture materials are in use in order to~     reconstitute the abdominal wall integrity, but there is no surgical gold standard for~     abdominal wall closure until today. Various Meta-Analyses and randomized controlled trials~     have been performed, which compared non-absorbable or long-term absorbable versus rapid~     absorbable suture materials or monofilament versus multifilament suture materials, or~     continuous versus interrupted suture techniques respectively. This lack of evidence has the~     following outcome: burst abdomen is observed in 1-3% of patients within the first days after~     a laparotomy. The incidence of abdominal wall hernias 12 months postoperatively is estimated~     to be up to 20% (range 9 to 20%) . Wound infections develop in 3 to 21% of patients~     undergoing a median laparotomy within the first 30 days. At present most surgeons favour~     monofilament long-absorbable continuous sutures as the most suitable material for closing~     abdominal wounds after midline laparotomy.~   "
127307|NCT01901055|"~     Diabetes self-management is important to help adults with type 2 diabetes achieve glucose~     control. Obstructive sleep apnea often co-exists with type 2 diabetes and may act as a~     barrier to diabetes self-management and glucose control. We will examine if treatment of~     obstructive sleep apnea with continuous positive airway pressure (CPAP), combined with~     diabetes education, results in improved diabetes self-management and glucose control.~   "
127308|NCT01901042|"~     Radiation proctitis is quite common in treatment of pelvic tumors. We investigated whether~     the use of symbiotic would prevent early symptoms of radiation proctitis and improve the~     quality of life in patients undergoing radiotherapy for prostate cancer treatment. We~     randomized patients to intake one sachet of either a symbiotic product containing 4.3 g of~     dietary fiber and Lactobacillus reuteri in a concentration greater than 10(8)colony forming~     units (CFU)(Fibermais Flora Nestlé Brazil) or sachets containing 5 g of maltodextrin. They~     were instructed to dilute one sachet in 200mL of water and drink once a day during the week~     before the beginning of radiotherapy sessions, and increase the dose to two sachets daily~     after the beginning of the sessions for four weeks. Every week a questionnaire named EORTC~     QLQ-PRT23 was applied to evaluate GI symptoms and quality of life.~   "
127309|NCT01901029|"~     To determine the prevalence of sexual problems particularly premature ejaculation and~     erectile dysfunction among men working in factories of Dongguan city, using the self-rating~     scales like International Index of Erectile Function, and to investigate the characteristics~     or risk factors associated with these sexual problems in floating population through~     regression analysis.~   "
127310|NCT01901016|"~     Prevalence of depression is higher in people living with human immunodeficiency virus (PLHIV)~     than among seronegative people. Depressive symptoms have been observed in up to 40% of~     seropositive population. Presence of depressive symptoms has a negative impact on quality of~     life, optimal compliance of antiretroviral treatment, adoption of safe sexual behaviors, and~     on immune status and viral load.~      Although antidepressants and psychotherapeutic interventions -particularly those with~     cognitive-behavioral components— have been proven effective in decreasing depressive symptoms~     in PLHIV, their use is limited among other causes due to misdiagnosis, patient refusal,~     possible interaction with antiretroviral treatments, or unavailability in the case of~     psychotherapy. Furthermore, identification and assessment of more accessible interventions~     that would decrease depressive symptoms and improve quality of life in PLHIV has become a~     crucial objective in the management of this chronic disease.~      A meta-analysis shows that relaxation is an efficient intervention to reduce depressive~     symptoms in people diagnosed with depression or with high levels of depressive symptoms.~     According to some authors, relaxation, an easy-to-learn and self-applied intervention, proves~     to be a simple first line therapy capable of reducing depressive symptoms. However, the~     amount of relaxation needed to produce an effect on depression was not established in this~     meta-analysis and there are no results on the effects of relaxation in people whose~     depressive symptoms were caused by other diseases and only a study which includes PLHIV.~      Given the prevalence of depressive symptoms and its consequences on the health of PLHIV and~     given the effects of relaxation on depressive symptoms, this pilot project aims to evaluate~     feasibility and acceptability of a relaxation intervention in PLHIV who suffer depressive~     symptoms, assess the feasibility and acceptability of the research project and assess the~     preliminary effects of a relaxation intervention.~   "
127311|NCT01901003|"~     Seven French university hospitals will participate in this multicentric prospective, blinded~     and randomized study. The investigators designed 3 study groups: Lorazepam 2.5mg, Placebo~     (microcrystalline celluloses) and no premedication at all. The third group (no premedication)~     is necessary in order to evaluate a placebo response, which may be significant on anxiety~     level and patients perceptions of care. It was calculated that 969 patients had to be~     included in order to obtain a 5 point difference between groups on the EVAN score with 80 %~     statistical power, leading to the inclusion of 1200 patients with an estimated maximum~     dropout rate of 15 %. All adults below 70 years and scheduled for elective surgery under~     general anesthesia can be included after information by an anesthesiologist in charge of the~     study and written informed consent. Non inclusion criterions are: a weight below 45 Kg, a~     counter indication to benzodiazepine, surgeries that could impair cognitive functions~     (cardiac or neurologic surgery), usual use of neuroleptics or lithium, drug addiction or~     former cognitive disease. The technique of anesthesia will be decided by the attending~     anesthesiologist, who will be unaware of the premedication technique, independently of the~     study protocol.~   "
127312|NCT01900990|"~     The investigators adopt Noninvasive Positive Pressure Ventilation for weaning in tracheotomy~     patients innovatively. The investigators randomly allocate the subjects into two groups. One~     group is weaned by traditional strategy. The other one is weaned by Noninvasive Positive~     Pressure Ventilation by plugging the tracheotomy tube and deflating the cuff.~   "
127313|NCT01900977|"~     PopART is a community randomized trial that is investigating whether a community-wide~     combination HIV prevention package including annual home-based HIV testing, active referral~     and the offer of immediate ART for those testing HIV-positive, along with the promotion of~     proven HIV prevention methods (such as voluntary medical male circumcision, prevention of~     mother to child transmission and condom use), will help to prevent transmission and~     substantially reduce new HIV infections. The study is being conducted in 21 communities in~     Zambia and South Africa (randomized into 3 arms, each with 7 communities) with a total~     population of approximately 1.2 million individuals.~   "
127314|NCT01900964|"~     A non-resorbable PTFE (teflon) membrane will be compared to a resorbable collagen membrane~     when used for a post-extraction ridge preservation procedure to prevent the bone loss that~     typically occurs. The hypothesis is that there will be no difference in the clinical and~     histologic results between the two membranes.~   "
127315|NCT01900951|"~     Temozolomide, a nonclassic oral alkylating agent, may delay progression in sequence with~     chemotherapy. This phase II trial was designed to evaluate the role of Temozolomide following~     4 or 6 cycles of first-line treatment in patients with newly diagnosed SCLC.~   "
127318|NCT01900912|"~     Behavioral change is a key ingredient for successful adoption of better sanitation practices~     in rural Africa. Sanitation programs have, for some time now, incorporated the need to raise~     awareness and emphasize the benefits of toilet usage. These endeavors, often combined with~     subsidies linked to toilet construction by households, seek to create a demand for sanitation~     goods. Yet, progress in securing the desired outcomes from sanitation programs has been slow.~     Moreover, benefits of sanitation largely take the form of externalities, which individuals do~     not take into account when making their own decisions about investments. This makes~     sanitation promotion at the household level particularly challenging.~      A new approach to sanitation entails a shift away from the provision of subsidies for toilets~     to individual households and a promotion of behavioral change at individual-level towards~     emphasizing collective decision-making in order to produce 'open defecation-free' villages.~     The objective of the intervention is to reduce the incidence of diseases related to poor~     sanitation and manage public risks posed by the failure to safely confine the excreta of some~     community members. The way to achieve this objective is by empowering communities motivated~     to take collective action. Local governments and other agencies perform a facilitating role.~     There is a growing recognition that this approach, referred to as Community-Led Total~     Sanitation (CLTS), may help with the reduction of open defecation practices. However, no~     rigorous impact evaluation of CLTS has been conducted so far. This randomized controlled~     trial will study the effect of CLTS in rural Mali. As a result, sound evidence will become~     available to see to what extent CLTS improves health outcomes and what is driving collective~     action in order to increase sanitation coverage.~      The direct recipients of the intervention are members of rural communities in Mali who aspire~     to live in a cleaner environment. The donor community, international organizations, and~     governments in developing countries will benefit from having simple and clear evidence on the~     effectiveness of an innovative program for improving sanitation in rural areas. They will~     learn whether the program has worked or failed to achieve its objective of eradicating open~     defecation, and about key factors explaining success and failure.~   "
127319|NCT01900899|"~     The purpose of this study is to evaluate the long-term antibody persistence as well as safety~     of GSK Biologicals' MenACWY-TT vaccine versus Meningitec up to 6 years after booster~     vaccination administered in healthy 5 year old children in the study MENACWY-TT-048 EXT: 039~     Y2, 3, 4, 5 (NCT00955682), who were primed with the same vaccine in the study MENACWY-TT-039~     (NCT00474266) at 12 through 23 months of age.~   "
127320|NCT01900886|"~     Primary objective: Evaluate the prevalence of personality disorders in patients starting~     treatment for hepatitis C in the prison and determine their influence on the evolution of the~     disease.~   "
127321|NCT01900873|"~     Patients with chronic obstructive pulmonary disease are often limited in their exercise~     capacity by intolerable shortness of breath (dyspnea). Patients are breathing at high lung~     volumes during exercise which forces inspiratory muscles to work at a high percentage of~     their maximal capacity. This increased inspiratory effort has been shown to be independently~     related to symptoms of dyspnea during exercise in previous research. Eight weeks of high~     intensity variable flow resistive inspiratory muscle training is hypothesized to reduce~     inspiratory effort and to decrease neural drive to inspiratory muscles. These factors are~     hypothesized to jointly contribute to delaying the occurrence of intolerable symptoms of~     dyspnea and to improve exercise tolerance in these patients.~   "
127322|NCT01900860|"~     We propose to conduct a randomized double blind trial of three doses of vitamin D, 400, 4000,~     and 10,000 International Units (IU) per day, to assess the effect on bone density and~     architecture as assessed by high resolution peripheral quantitative tomography (HR-pQCT)~     measurements at the radius and distal tibia, and standard Dual X-ray absorptiometry (DXA).~     Other measures of bone and calcium metabolism will be assessed. The trial will last as long~     as three years. Approximately 300 healthy men and women, aged 50-70 years of age, will be~     recruited, and randomly assigned to one of the three doses of vitamin D. Other outcome~     variables assessed include quality of life, depression, muscle strength and balance.~   "
127323|NCT01900847|"~     Our goal is to study whether giving people low dose ketamine along with morphine when they~     come to the Emergency Department will help their pain more than giving morphine by itself.~     There have been many studies showing that low dose ketamine is safe and effective for pain~     control. Ketamine is frequently used for pain control in ambulances and helicopters~     transporting injured patients to the hospital and has also been used for pain control in~     people who have just had surgery. The investigators would like to see if low dose ketamine~     would be safe and effective for patients with pain in the Emergency Department.~      Patients are eligible for the study if they come to the Emergency Department and their~     treating physician decides to treat them with morphine (with certain exceptions such as~     pregnant patients and patients with eye injuries). They will be given information about~     participating in the study and if they agree, they will be given the study drug. The study~     drug will be either ketamine or salt water (saline). If patients continue to be in pain they~     will continue to receive doses of morphine just as they would if they were not in the study.~     If the treating physician feels that morphine alone is not enough, they will be free to~     choose another pain medication as they would normally.~   "
127324|NCT01900834|"~     This study is conducted in the United States of America (USA). The aim of this study is to~     assess longitudinal variation of immune biomarkers in subjects with type 1 diabetes (T1D),~     type 2 diabetes (T2D) and healthy, non-diabetic subjects over a one year period.~   "
127325|NCT01900821|"~     The National Mammography Database (NMD) leverages data that radiology practices are already~     collecting under federal mandate by providing them with comparative information for national~     and regional benchmarking. Participants receive semi-annual feedback reports that include~     important benchmark data such as cancer detection rates, positive predictive value rates and~     recall rates. Participation in the NMD is free to Breast Imaging Center of Excellence (BICOE)~     facilities.~   "
127326|NCT01900808|"~     Transient elastography (TE)is the reference method to identify liver stiffness (LSM) but~     fails to obtain a measurement in 3% of cases and results are considered unreliable in 16%.~     The aim of this study is to evaluate the applicability and diagnostic accuracy of TE~     performed by trained operators (<500 explorations), after a second evaluation by experienced~     explorers (>500 explorations) and after a third exploration using XL probe. Inadequate LSM~     will be re-evaluated by experienced operators with the M (standard size) probe. A third~     register will be performed with XL (obese size) probe in those patients with inadequate M~     probe determination. Diagnostic accuracy will be estimated in patients with liver biopsy to~     identify significant fibrosis with a TE cut-off value of 7.6 kPa (kilo pascal).~   "
127327|NCT01900795|"~     The primary objective of this study is to assess the analgesic properties of an oral dose of~     V117957 4.5 mg aqueous suspension in the third molar extraction model~   "
127328|NCT01900782|"~     This withdrawn study was to assess the safety and efficacy of secukinumab compared to~     etanercept and placebo in patients who have moderate to severe, chronic, plaque-type~     psoriasis.~   "
127329|NCT01900769|"~     Although blood volume is such an important parameter in everyday clinical medicine it cannot~     be measured easily. As a matter of fact, it is almost never measured but estimated or~     calculated based upon numbers derived from mostly healthy patients.~      The investigators do not even know whether someone's normal - i.e. before a surgery - blood~     volume is actually anywhere close to the generally accepted estimate or calculation.~      Tests exist in which a substance of known concentration is diluted in a person's blood volume~     and the resulting concentration is then measured, which allows the blood volume to be~     calculated. However, none of these tests can be completed at the bedside since they are not~     fast and require considerable set-up.~      This study turns the above approach upside-down: we will dilute the blood slightly with a~     known small volume of an intravenous fluid commonly used in many clinical settings and~     measure the concentra-tion of hemoglobin - the oxygen carrier contained in red blood cells -~     before and after adding the fluid. That allows for similar calculations without using neither~     specialized substances nor equipment.~      Hemoglobin is routinely measured in laboratories and is often a routine test before and~     during surg-eries and in intensive care units.~      Devices that can measure hemoglobin through the skin without actually drawing any blood are~     avail-able. If found comparable to laboratory determination of hemoglobin they could provide~     for a bedside and almost real-time assessment of blood volume, something that could be~     extremely valuable for de-cision making in critical areas of medicine and promoting goal~     directed therapies.~   "
127330|NCT01900756|"~     The purpose of this study is to determine whether a culturally-sensitive multipronged~     post-discharge intervention can significantly reduce blood pressure, enhance achievement of~     guideline recommended targets for risk factor control, and lower recurrent vascular events in~     a low-income and middle-income (LMIC). The study will have 2 Phases - a qualitative phase~     (Phase 1) lasting less than one year involving development of the intervention through focus~     group methodologies and structured interviews, and a clinical trial phase (Phase 2)lasting 3~     years involving a randomized trial testing the efficacy of the intervention.~   "
127331|NCT01900743|"~     This is an international (France, Austria and Germany), randomized, double-blind,~     placebo-controlled, phase II study to evaluate the efficacy and safety of regorafenib in~     patients with histologically proven metastatic and/or unresectable Soft Tissue Sarcoma (STS)~     after failure or intolerance to doxorubicin (or other anthracycline).~      Five cohorts will be defined:~      Cohort A: Liposarcoma Cohort B: Leiomyosarcoma Cohort C: Synovial sarcoma Cohort D: other~     sarcomas (see Appendix C) Cohort E: Leiomyosarcoma, Synovial sarcoma and other sarcomas~     listed in Appendix C previously treated with pazopanib Approximately 226 patients who meet~     the eligibility criteria will be randomly assigned in a 1:1 ratio to one of the treatment~     groups.~   "
127332|NCT01900730|"~     The goal of this clinical research study is to learn if receiving valproic acid (VPA)~     compared to a placebo can reduce the amount of time you will need to have an indwelling~     pleural catheter compared to the standard of care, which involves using an indwelling pleural~     catheter alone.~      VPA is designed to stop cancer cells from dividing and maturing. This may cause the cancer~     cells to become less malignant and cause less pleural fluid production.~      A placebo is not a drug. It looks like the study drug but is not designed to treat any~     disease or illness. It is designed to be compared with a study drug to learn if the study~     drug has any real effect.~   "
127333|NCT01900717|"~     To evaluate tolerance to and efficacy of bevacizumab in the treatment of MCRC in elderly~     patients, we propose a phase II randomised study comparing a chemotherapy + bevacizumab arm~     with a chemotherapy alone arm in the first-line treatment of MCRC in patients aged 75 years~     and older.~      This study is destined to continue as a phase III trial if both arms meet the selection~     criteria to show or not the benefits of treatment with bevacizumab combined with~     chemotherapy.~   "
127334|NCT01900704|"~     To investigate the efficacy and safety of SER120 nasal spray formulations in patients with~     nocturia~   "
127335|NCT01900691|"~     The CLARITY study is a clinical trial approved by US FDA to study the removal of the~     Evolution® Esophageal Stent-Fully Covered in malignant and benign indications.~   "
127336|NCT01900678|"~     The objective of this investigation is to evaluate whether pulmonary vein isolation using the~     VytronUS ablation system is safe and effective acutely and at 3 months.~   "
127337|NCT01900665|"~     To test the idea that solanezumab will slow the cognitive decline of Alzheimer's Disease (AD)~     as compared with placebo in participants with mild AD.~   "
127338|NCT01900652|"~     The primary purpose of this study is to evaluate the efficacy of the study drug known as~     LY2875358, administered alone or in combination with a second drug named Erlotinib, in~     participants affected by a defined type of lung cancer (MET biomarker diagnostic positive~     Non-Small-Cell Lung Cancer) that experienced a disease progression during the most recent~     treatment with Erlotinib.~   "
127339|NCT01900639|"~     Low-dose aspirin is a cornerstone in the secondary prevention of cardiovascular disease (CVD)~     and is usually taken on awakening, although evidence regarding optimal time of intake is~     lacking. Platelet reactivity follows a circadian rhythm, with a peak in the morning,~     contributing to the morning peak of cardiovascular disease. Due to its short half life,~     aspirin only inhibits platelets which are present at the time of intake. Thus, the timing of~     aspirin intake may influence its inhibitory effect on platelets and intake of aspirin at~     bedtime may attenuate the morning peak of platelet reactivity. The time-dependent effect of~     aspirin on circadian rhythm of platelet function has never been studied before. We~     hypothesize that aspirin intake at bedtime compared with intake on awakening results in a~     reduction of the morning peak in platelet reactivity.~   "
127340|NCT01900626|"~     This is a study comparing pain control utlilizing one or two epidural catheters, along with a~     hydromorphone PCA, for analgesia following surgery for correction of scoliosis.~   "
127396|NCT01899885|"~     The objective of this study is to implement an optimized perioperative course for patients~     undergoing acute high-risk abdominal surgery in order to improve the outcome.~      The optimized perioperative course consists of a number of interventions carried out before,~     during and after surgery.~   "
127397|NCT01899872|"~     The aim of this study is to evaluate the effect of a single session of aerobic plus~     resistance exercises on the vascular function of patients with type 1 diabetes mellitus. The~     investigators hypothesize that a single aerobic exercise session would promote greater~     benefit in vascular function of patients with type 1 diabetes, as compared with the resistive~     exercise session.~   "
127341|NCT01900613|"~     Obesity and overweight are health problems resulting from the interaction of predisposing~     genes with environmental, economic and social stimuli, in conjunction with excess caloric~     intake throughout growth from childhood to adulthood. Evidence suggests that a major barrier~     in controlling overweight/obesity is the complex interrelation of these factors, making~     single-approach interventions less likely to succeed than integrated, multi-faceted~     approaches. The proposed project aims to deliver a multi-faceted behavioral intervention~     developed over the past 18 months by a university-community /school-based collaborative. This~     project aims to provide new knowledge about the effectiveness of interventions designed~     specifically to achieve successful weight management among Mexican-origin children ages 3-8,~     and identify associated mediating factors. Deliverables will include community-based,~     collaborative and sustainable tools to support weight-management goals in this demographic.~     UC Davis and UC Cooperative Extension (UCCE) faculty form the investigator team,~     collaborating on key decision points with the project community in California's Central~     Valley. The investigators hypothesize that the identified mediating factors will increase~     fruit and vegetable consumption. The investigators also hypothesize an increase in the~     intensity and frequency of physical activity among children in the intervention group.~   "
127342|NCT01900600|"~     The proposed study is a sub-study of the CANTOS trial (A randomized, double-blind,~     placebo-controlled, event driven trial of quarterly subcutaneous canakinumab in the~     prevention of recurrent cardiovascular events among stable post-myocardial infarction~     patients with elevated high sensitivity C-reaction protein (hsCRP) [CACZ885M2301]).~      The study proposes to perform serial Cardiopulmonary Exercise Tests (CPX) to prospectively~     measure changes in aerobic exercise capacity in patients with prior myocardial infarction~     (MI), elevated C reactive protein plasma levels, and symptomatic heart failure with reduced~     systolic function, who are enrolled in the main CANTOS trial and are randomly assigned to~     Canakinumab (3 different doses) or Placebo.~      The subjects enrolled in this substudy will undergo repeated CPX and echocardiograms over the~     first 12 months of the CANTOS trial. The subjects will received the experimental treatment as~     randomized in the main CANTOS trial and they will not receive any additional experimental~     treatment as part of the sub-study.~      This study is a an Investigator-initiated (Dr. Abbate) single-center (Virginia Commonwealth~     University) sub-study of the CANTOS trial, supported by Novartis pharmaceuticals.~   "
127343|NCT01900587|"~     The purpose of this study is to evaluate bio-equivalence of tapentadol extended-release (ER)~     tamper-resistant formulation (TRF) tablet, to the current tapentadol ER, prolonged-release~     formulation 2 (PR2) tablet, in healthy participants.~   "
127344|NCT01900574|"~     The purpose of this study is to evaluate the pharmacokinetics (what the body does to the~     study medication) and safety of subcutaneously (under the skin) administered golimumab in~     pediatric participants (aged 2 to 17 years) with moderately to severely active Ulcerative~     Colitis (UC).~   "
127345|NCT01900561|"~     This study will provide much needed information about how to optimize the quality of care and~     quality of life of Veterans who are survivors of prostate cancer.~   "
127346|NCT01900548|"~     The aim of this study is to investigate potential metabolic effects of whey protein high in~     protein and high in leucine(HPHL) compared to soy protein high in protein and low in~     leucine(HPLL) in osteopenic patients in a randomized controlled intervention study.~      The investigator hypothesize that HPHL will increase physical function and the ratio muscle~     mass / fat mass in this condition.~   "
127347|NCT01900535|"~     The purpose of this study is to evaluate the usefulness of triphala mouthwash in comparison~     with the gold standard chlorhexidine in hospitalized and periodontally diseased patients.~   "
127348|NCT01900522|"~     The purpose of this study is to characterize the safety and tolerability profile of ITI-214~     when administered as multiple doses of oral solution at escalating dose levels.~   "
127349|NCT01900509|"~     Participants with relapsed or refractory leukemia or lymphoma will be recruited for this~     study to find whether or not the addition of a new drug called bendamustine will be safe and~     possible to give with other chemotherapy drugs. This drug is approved by the Food and Drug~     Administration (FDA) for the treatment of other cancers in adults that are similar to those~     being studied in the research trial.~      PRIMARY OBJECTIVES~        -  To establish the maximum tolerated dose (MTD) of bendamustine in combination with~          clofarabine and etoposide in pediatric participants with hematologic malignancies.~        -  To characterize the safety profile and dose-limiting toxicities (DLTs) of bendamustine~          in combination with clofarabine and etoposide.~      SECONDARY OBJECTIVES~        -  To estimate event-free survival at 4 months.~        -  To estimate minimal residual disease (MRD) levels present at end of each cycle of~          therapy in participants with leukemia.~        -  To characterize the pharmacokinetic profile of bendamustine in the proposed regimen.~   "
127350|NCT01900496|"~     This research is being done to study a combination of Brentuximab vedotin and Rituximab for~     the treatment of relapsed Hodgkin's Lymphoma (HL).~   "
127351|NCT01900483|"~     The project will specifically focus on the examination of the influence of substantial weight~     loss due to bariatric surgery on brain functions. Our hypothesis is that substantial weight~     loss after Bariatric Surgery (BS) is also accompanied by changes in the balance of reward and~     inhibitory networks in diabetic subjects. Therefore the investigators will conduct a~     functional magnetic resonance imaging (fMRI) study investigating functional measures.~   "
127352|NCT01900470|"~     The purpose of this proposal is to compare the effectiveness of community health worker (CHW)~     support vs. usual primary care for helping chronically-ill, low-SES patients to improve~     control of chronic conditions. Upon enrollment each patient will select one of their multiple~     chronic conditions as a focus for the trial and work with his/her PCP to set a chronic~     disease management goal. Patients are then randomized to receive usual primary care vs. CHW~     support for moving towards that goal.~   "
127398|NCT01899859|"~     The primary objective of this study is to characterize the safety, tolerability and~     dose-limiting toxicities (DLTs) for GR-MD-02 when administered intravenously to subjects with~     biopsy-proven NASH with advanced liver fibrosis.~   "
127654|NCT01896479|"~     The objective of this study is to evaluate the efficacy and safety of oral cabozantinib at a~     60 mg dose compared with a 140 mg dose in subjects with progressive, metastatic MTC. It will~     test if the lower dose results in similar progression free survival (PFS) and overall~     response rate (ORR) with fewer adverse events compared to the PFS, ORR and adverse events~     found in previous clinical trials of 140 mg.~   "
127353|NCT01900457|"~     The present project aims at describing how vestibular signals contribute to the multisensory~     mechanisms of bodily self-consciousness.~      There is a large body of data regarding the sensory and neural mechanisms of~     self-consciousness, but most studies have so far demonstrated the contribution of visual,~     tactile and proprioceptive signals to bodily self-consciousness. Thus, most studies have~     neglected the contribution of the vestibular system, a major sensory system for spatial and~     bodily representations. The vestibular system is sensitive to head motions in space and head~     inclinations with respect to gravity and it should therefore contribute significantly to~     several bodily experiences. This contribution should be put under neuroscientific scrutiny.~     We believe that the current neuroscientific models of bodily self-consciousness will be~     incomplete until they incorporate the contribution of vestibular signals.~      The present project specifically aims at testing the hypothesis according to which vestibular~     signals significantly influence bodily self-consciousness, in particular first-person and~     third-person perspective taking and the internal body models (i.e. the body schema and body~     image). The present project also aims at describing how cortical vestibular processing is~     modified during experimental changes of perspective taking and viewpoint. In addition, the~     present project will describe whether vestibular disorders change performances in~     third-person perspective taking tasks and modify internal body models. This should help~     understanding bodily symptoms in vestibular-defective patients. To this end, we will combine~     approaches from psychophysics and electrophysiology (electromyography,~     electroencephalography) in healthy volunteers and behavioral approached in patients with~     vestibular disorders.~      These studies should further the understanding of how the brain processes vestibular signals,~     which is to date poorly understood. In addition, the outcome of the present project should~     help understanding the multiple and complex symptoms reported by patients with vestibular~     diseases, and should therefore improve their treatment.~   "
127354|NCT01900444|"~     The aim of this study was to document the immunogenicity and safety of a booster dose of~     IMOJEV administered at least 12 months after the primary dose.~      Primary objective:~        -  To describe the immune response to Japanese Encephalitis (JE) before and 28 days after a~          booster dose of IMOJEV administered at least 12 months after primary vaccination with~          IMOJEV.~      Exploratory objectives:~        -  To describe the safety profile of a booster dose of IMOJEV® .~   "
127355|NCT01900431|"~     Primary Objective:~      To evaluate the efficacy of sarilumab at Week 16 in participants with non-infectious uveitis~     (NIU).~      Secondary Objectives:~      To evaluate the change in best corrected visual acuity (BCVA). To evaluate the safety of~     subcutaneous sarilumab in participants with NIU. To evaluate the change in macular edema. To~     evaluate the change in other signs of ocular inflammation. To evaluate the effect on retinal~     vessel leakage. To evaluate the effect of sarilumab on reducing concomitant immunosuppressant~     therapy.~      To evaluate the change in ocular inflammation in the anterior chamber. To evaluate the~     pharmacokinetics of sarilumab in NIU participants. To evaluate the immunogenicity with~     anti-drug antibodies (ADA).~   "
127356|NCT01900418|"~     For post-menopausal women diagnosed with hormone-receptor positive breast cancer tumors,~     aromatase inhibitors (AIs) are the standard adjuvant hormone treatment to prolong~     disease-free survival and time-to-recurrence. Unfortunately, joint pain/stiffness/achiness~     (arthralgia) is a common side-effect of AIs. This proof-of-concept study explores how an~     evidence-based physical activity (PA) program- the Arthritis Foundation's Walk with Ease~     (WWE) program- can be adapted for breast cancer survivors on AI therapy to: 1) Help them~     maintain or achieve recommended levels of PA, 2) reduce their joint pain/stiffness/achiness,~     and 3) thereby enable them to remain on AI therapy as prescribed.~   "
127357|NCT01900405|"~     This study has the objective to determine if intranasal dexmedetomidine, a sedative, is~     suitable for pediatric sedation in children undergoing tomographic scans.~   "
127358|NCT01900392|"~     This study aims to evaluate the effectiveness of financial incentives in improving and~     maintaining weight loss.~   "
127359|NCT01900379|"~     The aim of this clinical trial is to evaluate the effect of obstructive sleep apnea syndrome~     (OSAS) treatment in heart failure patients following coronary artery bypass graft (CABG)~     surgery or other coronary reperfusion.~   "
127360|NCT01900366|"~     This study will test the potential of two techniques using light properties of adipose tissue~     to diagnose crown-like structures and inflammation to be compared with pathologic examination~     of adipose tissue biopsies from ongoing clinical studies.~   "
127361|NCT01900353|"~     The aim of this randomized, single-blind, split-mouth design, clinical trial was to evaluate~     the effectiveness in plaque removal of the vertical and the horizontal brushing methods.~     Trauma on soft tissues were also registered. Sixty-one (61) young adults were enrolled for~     this trial and forty-three (43) completed the brushing session. All subject were asked to~     abstain from oral hygiene procedures for 48 hours before the brushing session to allow~     adequate plaque accumulation. They were firstly instructed to use a dental disclosing tablet~     in order to easily permit to detect dental plaque on teeth and to highlight soft tissue~     abrasions. Plaque and the abrasion indexes were recorded according to the Rustogi Modified~     Navy Plaque Index (RMNPI) and the Danser Index (DI) by the same examiner. The brushing~     session was always performed by the same dental hygienist who brush with a randomized~     split-mouth design. After the brushing session, the blinded examiner recorded the indexes~     again.~   "
127362|NCT01900340|"~     The aim is to further establish a physiological role for GLP-1 as an endogenous satiety~     signal by examining the effect of the specific GLP-1 receptor antagonist exendin (9-39) on~     appetite and food intake in healthy male subjects.~   "
127363|NCT01900327|"~     Sequential Neoadjuvant Chemoradiotherapy (CRT) Followed by Curative Surgery vs. Primary~     Surgery Alone for Resectable, Non-metastasized Pancreatic Adenocarcinoma~   "
127364|NCT01900314|"~     The purpose of this research is to learn more about how rTMS works to reduce the symptoms of~     depression. This information can be used to improve the effectiveness of the treatment. The~     study will use functional magnetic resonance imaging (fMRI) to examine changes in brain~     function after treatment with rTMS. fMRI is a safe and painless technique that allows~     investigators to observe the brain at work. The investigators will use fMRI to see what~     regions of the brain become active when you perform a concentration task and how that~     activation is changed after rTMS.~   "
127408|NCT01899729|"~     IMO 8400 is a second-generation oligonucleotide antagonist of endosomal Toll-like receptors~     (TLR) 7, TLR8 and TLR9. These TLR react to complexes of exogenous nucleic acids (as might be~     encountered during infection) and endogenous nucleic acids (as might be released during~     tissue damage during autoimmune disease). In vitro and in multiple animal models of~     autoimmune disease, IMO-8400 blocks immune activation mediated through TLR7, 8 and 9. In~     Phase 1 studies (Protocol 8400-001) IMO 8400 has been administered to healthy adults by SC~     injection at single-doses and multiple-doses (4 weeks) up to 0.6 mg/kg. All treatments were~     well-tolerated, with mild injection site reactions and no pattern of systemic reactions or~     laboratory changes.~      The current study represents the first clinical trial of IMO-8400 in patients with active~     autoimmune disease. Moderate to severe plaque psoriasis was chosen for this 12-week proof of~     activity trial based on a prior 4-week study using a first generation TLR7 and 9 antagonist~     which demonstrated clinical improvement in this patient population.~   "
127365|NCT01900301|"~     Fear, whether it occurs in humans suffering from an anxiety disorder or in experimental~     models with rodents, is reduced by exposing the frightened organism to the fearful stimulus~     in the absence of any negative consequences (i.e., extinction, or exposure therapy). However,~     fear often renews when the feared stimulus is encountered in a context different from the~     exposure context. In rats, the investigators found that interfering with the animal's ability~     to process contexts during extinction by administering an anticholinergic drug prevented fear~     renewal. This proposal will determine if the beneficial effect of this drug translates to~     exposure therapy in socially anxious humans. To this end, 100 individuals with Social Phobia~     who fear public speaking will undergo repeated sessions of exposure to public speaking,~     within a virtual reality context. Participants will be randomized to either drug placebo,~     .2mg/.01 mL Scopolamine, .3mg/.01 mL Scopolamine or .4mg/.01 mL Scopolamine, administered via~     nasal drops, prior to each session of exposure therapy. One month after completion of~     exposure therapy, context renewal will be tested by comparing physiological and subjective~     responses to public speaking in the same virtual context as used during exposure therapy~     versus a context different than the one used during exposure therapy. The goal is to identify~     the dose of Scopolamine associated with the greatest reduction in context renewal. In~     addition, a secondary analysis will attempt to identify those individuals who benefit most~     from Scopolamine-augmentation of exposure therapy.~   "
127366|NCT01900288|"~     The purpose of this study is to test Mobile Technologies in Assisting Patients & Family~     Caregivers in Healthy Living and complex home care by connecting to information and~     professionals from a distance.~   "
127367|NCT01900275|"~     Across the world, the most common cause of dying in the ICU is a disease called sepsis.~     Sepsis is a disease in which the body's protective response to infection becomes too intense,~     unnecessarily damaging important organs in the body. Kidney damage during sepsis is~     particularly bad, as a person's chance of survival drops significantly when he or she~     develops kidney failure. This study plans to learn more about how to detect (and thus~     prevent) kidney failure early in sepsis. The current tests doctors use only detect kidney~     failure once it's already happened. We must therefore find better ways of detecting kidney~     failure earlier, when there is still a chance to protect the kidneys.~      In this study, patients will provide a one-time sample of urine. We will check this urine for~     signs of a protein called heparanase, which we believe is important in early kidney~     failure. We will then see if high heparanase activity in urine predicts the risk of~     developing kidney failure. We will compare results from patients with sepsis with results~     from patients with trauma, allowing us to determine if heparanase is only important in sepsis~     kidney failure.~   "
127368|NCT01900262|"~     The purpose of this study is to understand the effects of muscle strengthening and balance~     exercise interventions on muscle strength, running mechanics and postural control in novice~     recreational runners. Participants will be assessed before and after they engage in an 8-week~     exercise intervention program.~   "
127369|NCT01900249|"~     The purpose of this study is to determine whether 0.2% and 0.5% R348 Ophthalmic Solutions are~     safe and effective in the treatment of Patients with Keratoconjunctivitis Sicca.~   "
127370|NCT01900236|"~     iENGAGE is a 4 session, in-clinic behavioral intervention that is delivered to new clinic~     patients during the first year of HIV care on a flexible delivery schedule, with intervention~     visits scheduled to coincide with HIV medical care visits. Interventionists from each~     participating collaborating site will be trained centrally to implement the iENGAGE protocol.~     Following study enrollment and baseline assessment, participants will be randomized to~     treatment as usual and intervention groups. For intervention-arm participants, each iENGAGE~     intervention session includes: interventionist-delivered educational content for managing HIV~     medical care appointment-keeping and information sessions for learning to manage HIV~     medications. The intervention will have a tailored, interactive agenda for each of the 4~     sessions based on behavioral motivational interviewing (MI) techniques. The goal of this~     intervention is for the participant to establish early behaviors that help him/her to arrive~     at scheduled medical appointments and learn to take medications as prescribed during the~     initial year of HIV care in order to improve overall health.~   "
127371|NCT01900223|"~     Chronic pain is relatively common after different types of surgery. The investigators intend~     to study prevalence, characteristics and risk factors of chronic pain after shoulder~     arthroplasty, focusing on neuropathic pain characteristics, and risk factors such as~     preoperative pain, severe acute postoperative pain, age, gender, and pain elsewhere.~   "
127372|NCT01900210|"~     The purpose of the Texas Christian University (TCU) Disease Risk Reduction (DRR) Project is~     to develop and test an intervention designed to increase positive decision-making skills~     among offenders for healthy living, including skills for making decisions for reducing~     disease risk behaviors, particularly those involving HIV and Hepatitis B & C. This project~     focuses on the critical transition time between incarceration and return to the community.~   "
127373|NCT01900197|"~     The purpose of this study is to monitor and quality assure the efficacy and safety of~     Monofer® in a broad patient population when Monofer® is used according to the Monofer® label~     (SPC) in current practice and where standard routines are being followed.~   "
127374|NCT01900184|"~     1QG2 is a Phase 1 study aiming to assess the safety and tolerability of ascending~     single/multiple oral doses (SAD & MAD) in healthy young subjects, the preliminary food~     interaction and the effect of QGC001 on blood pressure and heart rate, but also to determine~     pharmacokinetic preliminary profiles of QGC001 and its metabolite EC33 and pharmacodynamic~     preliminary profiles of QGC001 and its metabolite EC33 especially effects on the~     renin-angiotensin-aldosterone and copeptin systems.~   "
127375|NCT01900171|"~     QGC001/1QG1 is a Phase I first time in man study aiming to determine the overall safety and~     tolerability of single ascending oral doses of QGC001 in healthy male subjects compared to~     placebo, as well as the pharmacokinetics of QGC001 and its metabolite EC33 and the~     pharmacodynamic properties of QGC001 (effects on the renin-angiotensin-aldosterone system,~     blood pressure and heart rate) in healthy male subjects.~   "
127376|NCT01900158|"~     This is a Phase I/II Dose Escalation Study in which the safety, tolerability and efficacy of~     Amphinex-induced Photochemical Internalisation (PCI) of Gemcitabine followed by~     Gemcitabine/Cisplatin Chemotherapy will be assessed in patients With advanced inoperable~     cholangiocarcinomas.~   "
127377|NCT01900132|"~     Background:~      - Electrical impedance myography (EIM) is a new technique being studied to see if it is~     helpful in evaluating muscle disorders and nerve disorders. EIM looks at how a mild, painless~     electrical current travels through muscles. Researchers want to gain experience in using the~     EIM device. They will collect information on the results of using it on people with and~     without nerve and muscle diseases, and compare that with information from other standard~     tests. First, they will test the device on healthy people. Then they will test people with a~     variety of neuromuscular diseases. Because the test is noninvasive and not painful,~     researchers will test both children and adults.~      Objectives:~      - To gain experience using the EIM muscle testing device.~      Eligibility:~        -  Healthy volunteers at least 2 years old.~        -  Individuals at least 2 years old who have neuromuscular disease.~      Design:~        -  Participants will be screened with a medical history and physical exam.~        -  Participants will have one 2 3 hour clinic visit. Researchers may request follow-up~          visits.~        -  Participants will be tested with the EIM device. The device and small electrodes will be~          placed on their skin. An electric current will pass through the device, but the~          participants will not feel this.~        -  Participants may have an ultrasound test. A gel will be put on their skin, and a device~          will be moved over the skin.~        -  Participants may have a nerve test. Electrodes will be placed on their skin, and they~          will feel a small shock.~        -  Participants may have a test where a thin needle is inserted in their muscle.~   "
127378|NCT01900119|"~     Background:~      - This research is being done to describe the types of bacteria found in the mouths of~     patients who have severe aplastic anemia (SAA) and are treated with drugs that suppress the~     immune system or with stem cell transplant. People with SAA who receive these treatments are~     more likely to get infections. Studies show that there might be a link between the bacteria~     in your mouth and those bacteria that can cause infections. The bacteria found in the mouths~     of patients with SAA will be described.~      Objectives:~      - To understand the changes in mouth bacteria that are related to treatment and to describe~     the oral bacterial environment.~      Eligibility:~        -  Adults at least 18 years of age who are going to be treated for SAA.~        -  Healthy volunteers at least 18 years of age.~      Design:~        -  Participants will answer questions about their medical history and dental care. Their~          mouths will be examined.~        -  Participants with SAA will be tested during treatment for their disease, over the course~          of 1 year. All participants with SAA will be tested at 3 scheduled appointments. Any~          participants who require a breathing tube will receive additional tests.~        -  Healthy volunteers will be tested during 1 visit.~        -  Participants will give two samples each time. A saliva sample will be taken with a~          disposable padded tool. Skin cells will be collected from the tongue with a small~          plastic brush.~   "
127379|NCT01900106|"~     1. PROTOCOL SUMMARY This is a prospective, randomized open-label, 2 arm, 3-phase trial to~     compare the 48-weeks virological response of two different regimens containing~     abacavir/lamivudine (abacavir/lamivudine +darunavir/ritonavir (DRV/r) vs abacavir/lamivudine~     + raltegravir (RAL) in antiretroviral therapy naive, HIV+ individuals presenting for care~     with CD4+ counts < 200/mm3.~      1.1 Clinical Objectives: Primary Objective: To compare the 48-week virological response to~     two different regimens containing abacavir/lamivudine (abacavir/lamivudine~     +darunavir/ritonavir (DRV/r) vs abacavir/lamivudine + raltegravir (RAL) in antiretroviral~     therapy naive, HIV+ individuals presenting for care with CD4+ counts < 200/mm3.~      Secondary Objective: a) To compare immunological response at 48 weeks; b) To determine the~     safety and tolerability of the 2 regimens.~      1.2 Study population: 350 in/out patients 1.3 Outcome Primary Endpoint~        -  Proportion of patients with HIV RNA<50 copies/mL after 48 weeks Secondary Endpoints(s)~        -  Change in CD4+ cell count from baseline through week 48~        -  Time to virological rebound 1.4 Study design: Multicentre, parallel group, randomised,~          open label, non-inferiority study 1.5 Treatment regimens: Arm A: abacavir/lamivudine 1~          tablet once a day + raltegravir 400 mg (1 tablet twice a day) Arm B: abacavir/lamivudine~          1 tablet once a day + ritonavir 100 mg + darunavir 800 mg once a day.~      All drugs have been approved for the treatment of HIV infection. The study population will~     consist of 350 HIV-positive, HLA B5701-negative patients. At baseline, patients will be~     randomized 1:1 to start abacavir/lamivudine plus either raltegravir or darunavir/ritonavir.~     Randomization will be stratified on the basis of the screening CD4+ cell count (≤100 vs ≥100~     cells/µL), to ensure balance across treatments groups 1.7 Criteria for Safety: Adverse events~     and laboratory assessments. 1.8 Statistical analysis: As this is a non-inferiority trial, we~     will calculate the difference in the proportions of patients experiencing the primary outcome~     in the two treatment arms and will calculate a 95% confidence interval for this.~     Non-inferiority of the raltegravir arm will be demonstrated if the lower limit of the 95%~     confidence interval is greater than -12%. In case non-inferiority will be met, analyses for~     superiority will be performed.~   "
127380|NCT01900093|"~     Although ACTHAR gel is approved for the treatment of acute relapses, it is currently not~     widely used. Thus, we propose to conduct a small open-label proof-of-concept trial to~     evaluate the response to ACTHAR gel therapy in patients who have failed to make a~     satisfactory recovery after treatment with high dose IVMP. Documentation of the clinical~     course as well as any adverse events related to IVMP use will be made. The investigators~     propose to study the potential benefit of a 14-day course (the dose historically used since~     the landmark clinical trial of Rose et al1) of subcutaneous ACTHAR gel in 10 patients who~     have demonstrated inadequate improvement after a course of IVMP, 1000 mg daily, for 5~     treatments (over a maximum of 8 days). These would be patients for whom PLEX would be~     considered as a treatment possibility. The primary outcome measure will be improvement in the~     targeted neurological deficit, as measured on the appropriate functional system score (FSS)~     of the EDSS.~   "
127381|NCT01900080|"~     The purpose of this study is to determine if same-day HIV testing and antiretroviral therapy~     (ART) initiation improves retention in care (as measured by the proportion of participants~     who are alive and in-care with an undetectable viral load 12 months after HIV testing),~     compared with standard of care (three visits prior to ART initiation). Secondary outcomes~     include survival, ART initiation, retention in care with viral load < 200 and < 1000~     copies/ml, 6-month viral load, and adherence as measured by self-report and pharmacy refill~     records. Enrollment for the main study was completed in October 2015.~      In June 2015, enrollment was started for a new sub-study. This sub-study, funded by MAC AIDS,~     includes patients with WHO stage 1 or 2 disease and CD4 count >500 cells/mm3. The purpose of~     the sub-study is to compare 6-month retention for patients who receive same-day ART vs.~     standard pre-ART care. Secondary outcomes include adherence to INH and Bactrim, and~     cost-effectiveness between the two groups. Enrollment for the sub-study is ongoing.~   "
127382|NCT01900067|"~     The investigation was designed as an Open-Label, Multicenter, Randomised, Controlled~     Investigation to Evaluate the Efficacy and Safety of the BARRIER® EasyWarm Active~     Self-Warming Blanket Used for Continuous Active Warming to Prevent General Anaesthesia~     Induced Hypothermia During the Perioperative Surgical Period. Null hypothesis (H0): There is~     no difference between the two study populations (interventional treatment group versus~     control treatment group) regarding the average of core body temperature measurements during~     the perioperative phase.Alternative hypothesis (H1): The average of core body temperature~     measurements during the perioperative phase is significantly higher in the interventional~     group compared to that of the control group.~   "
127386|NCT01900015|"~     Primary Objective:~      To compare the impact of switching from efavirenz (EFV) plus two nucleoside analogs to~     rategravir (RAL) plus two nucleoside analogs versus keeping the same antiretroviral regimen~     on hepatic steatosis (HS) as measured by the controlled attenuation parameter (CAP) among~     HIV/HCV-coinfected patient.~      Secondary Trial Objective:~        1. To compare the proportion of HIV/HCV-coinfected patients with one category decrease in~          the grade of HS between patients continuing with EFV plus two nucleoside analogs and~          those switching from EFV plus two nucleoside analogs to RAL plus two nucleoside analogs.~        2. To evaluate the proportion of patients who maintain viral control (HIV RNA < 50~          copies/mL) after switching.~      Design:~      Open-label, randomized clinical trial to evaluate safety (phase IV)~      Condition:~      HIV and HCV coinfection.~      Intervention:~      Patients on current EFV plus two nucleoside analogs will be randomly assigned to switch EFV~     to RAL (400mg BID), maintaining nucleoside analogs unchanged, or to continue the current~     regimen.~   "
127387|NCT01900002|"~     The goal of this clinical research study is to learn about the safety of combining sorafenib~     with TheraSphere in the treatment of patients with advanced liver cancer.~   "
127388|NCT01899989|"~     The purpose of this study is to determine if the use of exploratory immunologic biomarkers,~     functional MRI images can serve as early predictors for response of NSCLC. It also will~     provide important information on the perceived side effects from a patient perspective.~     Patients may participate if they have tumors ≥3 cm without lymph node involvement (for which~     chemotherapy is not part of the standard of care). Patients will only receive stereotactic~     body radiation therapy (SBRT) per standard dose guidelines.~   "
127389|NCT01899976|"~     The purpose of this study is to provide safety and efficacy data for the X-Suit NIR® Covered~     Biliary Metallic Stent for subjects with malignant stricture(s) in the biliary tree. The~     study is designed to support the regulatory requirement of a 510(k) marketing application in~     the United States.~   "
127390|NCT01899963|"~     In this province, optometrists are often responsible for contacting the retinal specialists'~     office to arrange patients to be examined for suspected emergencies or more routine referrals~     related to the eye. This is often done by faxing a referral form to the specialists' office,~     where the retinal specialist will examine the information presented in the referral form and~     make a decision on when the patient should be seen. This current method has some important~     considerations, such as the difficulty of transmitting clear images of the back of the eye~     over fax. Having this information could help the retinal specialist in determining when the~     patient should be seen, especially in terms of booking additional tests or when treatment~     should be given.~      Teleophthalmology is a branch of telemedicine that delivers eye care through digital~     equipment and telecommunications technology. It offers some unique advantages, such as the~     ability to be integrated with electronic health records, the ability to be viewed by multiple~     members of the health care team, and potentially reduce wait times and travel times to the~     ophthalmologist.~      However, there is no comparison known to the study team between whether patients being~     referred from optometrists to retina specialists through a teleophthalmology system will be~     treated earlier than patients through a conventional fax system. This study aims to examine~     and provide more information on this topic.~   "
127391|NCT01899950|"~     Niemann-Pick Disease, Type C (NPC) is a rare neurodegenerative disorder with a wide clinical~     spectrum and variable age of onset. Classically, children with NPC demonstrate neurological~     dysfunction with cerebellar ataxia (an inability to coordinate balance, gait, extremity and~     eye movements), dysarthria (difficulty speaking), seizures, vertical gaze palsy (ability to~     move eyes in the same direction) motor impairment, dysphagia (trouble swallowing), psychotic~     episodes, and progressive dementia. There is no curative treatment for NPC and it is a lethal~     disorder. The purpose of this protocol is to obtain both baseline and rate of progression~     data on a clinical and biochemical markers that may later be used as outcome measures in a~     clinical trial. Specifically, this study will examine and characterize the longitudinal~     progression of neurocognitive symptoms of NPC with the goal of identifying early markers of~     disease progression that may be utilized in later trials to evaluate treatment efficacy.~   "
127392|NCT01899937|"~     Flow mediated dilation (FMD) of the brachial artery has been widely used as a non-invasive~     measure of endothelial function. FMD independently predicts future cardiovascular events and~     can be readily influenced by pharmacological, dietary or lifestyle interventions. However,~     the interpretation of FMD data is currently importantly hampered by differences in~     measurement methodologies and analysis techniques between laboratories. These differences~     result in large variation of 'normal' values between laboratories, highlighting the need for~     adopting widely supported and evidence-based guidelines.~   "
127393|NCT01899924|"~     The main objective of this study is to describe differential cognitive processing of various~     stimuli by a population of control subjects and a population of patients with selective~     cognitive deficits or altered states of consciousness by using dedicated ERP paradigms and~     high-density EEG picked up system.~   "
127394|NCT01899911|"~     A clinical study designed to determine the accuracy of the peripheral capillary oxygen~     saturation (SpO2) function of the Vital Signs Patch (VSP) device for measuring blood~     saturation level.~   "
127395|NCT01899898|"~     One third of children with epilepsy have seizures that are medically intractable.~     Uncontrolled seizures pose a variety of risks to children, including higher rates of~     mortality, developmental delay and cognitive impairment. Epilepsy surgery is not a feasible~     option for most children with refractory epilepsy. The ketogenic diet and the modified Atkins~     diet have been shown to be effective alternative treatments in children with refractory~     epilepsy. However, these need parents to be educated, and understand complex instructions of~     weighing foods and diet preparation. Therefore, children with parents with low levels of~     literacy and poor socioeconomic status have not been able to benefit from these therapies.~     Also, the paucity of trained dieticians and limited availability of labeled foods in~     resource-constraint settings has made these dietary therapies even more inaccessible.~      This study aimed to to develop a simple-to-administer variation of the modified Atkins diet~     for use in children with refractory epilepsy and to evaluate the efficacy and tolerability of~     this simplified modified Atkins diet in children with refractory epilepsy in a randomized~     controlled open-label trial.~   "
127399|NCT01899846|"~     This study will evaluate the levels of hydroxyprogesterone caproate and it's metabolites in~     blood throughout pregnancy~      There will be 3 cohorts of subjects~      Cohort 1 (6 subjects) will have daily blood draws in the morning at approximately the same~     time each day for one week following their first dose of Makena and will have blood drawn~     immediately prior to 2 successive Makena doses during Epoch 1 (24 - 28 weeks) and Epoch 2 (32~     - 36 weeks)~      Cohort 2 (8 subjects) will have blood drawn to determine the trough concentration 7 days~     after their first dose of Makena. Subjects will have daily blood draws for one week following~     a dose of Makena given in Epoch 1 (24 - 28 weeks) and blood drawn immediately prior to 2~     successive doses during Epoch 2 (32 - 36 weeks)~      Cohort 3 (16 subjects) will have blood drawn to determine the trough concentration 7 days~     after their first dose of Makena. Subjects will have blood drawn immediately prior to 2~     successive doses in Epoch 1 (24 - 28 weeks) and daily blood draws for one week following a~     dose of Makena given during Epoch 2 (32 - 36 weeks)~      A maximum of 10 subjects will be monitored on selected days following a completed course of~     Makena therapy to determine the terminal elimination phase.~   "
127400|NCT01899833|"~     This study will compare how well a new radiolabeled imaging agent ECDG compares to the~     current testing for coronary artery disease (radiolabeled Sestamibi) during a rest and stress~     cardiac test as documented from results of a coronary angiogram (if performed).~   "
127401|NCT01899820|"~     Artemisinin-based combination therapies (ACTs) are recommended for use against uncomplicated~     malaria in areas of multi-drug resistant malaria. The Ministry of Health, Division of Malaria~     Control (DOMC) rolled out the use of artemether-lumefantrine as the first line treatment for~     uncomplicated malaria in 2006.The development of the ACTs and its derivatives are the most~     rapidly acting of all the current antimalarial drugs and recognition of their potential role~     as a component of combination therapy have led to several large trials aimed at assessing~     different combinations of existing drugs, and to the specific development of new combination~     drugs.~      This proposal aims to (1) evaluate the efficacy of artemisinin-based anti-malaria combination~     drugs in different sites across Kenya (2) elucidate the markers of resistance to ACTs through~     molecular genetics and in this process further strengthen capacity in the proposed study~     sites as well as improve links between research and control ultimately to influence malaria~     treatment policy and practice.~      Five groups in East Africa will conduct a multi-centre, randomised, two arm trial to assess~     the efficacy of dihydroartemisin-piperaquine with artemether-lumefantrine as the comparative~     drug. The network will determine antimalarial drug efficacy using standardised protocols and~     collate clinical responses and adverse events. Molecular markers to artemisinin resistance~     will be investigated by molecular sequencing and comparison of parasite profiles in drug~     failure cases. Recrudescence or re-infections will be differentiated by analysis of the MSP1,~     MSP2 and GLURP genes and assess transmission dynamics post treatment. Data from these studies~     will be captured into a database developed by the network. The latter offers several~     advantages including~        -  Working towards the standardization of methodologies and common protocols as a way of~          comparing data across sites~        -  Pulling together datasets and conduct a multi-centre analysis~        -  Sharing and coordinating quality assurance mechanisms~   "
127402|NCT01899807|"~     The purpose of this study is to evaluate a new ceramic metal bone graft substitute for hemi~     craniectomies. The frequency of infections and rupture of skin will be studied, which is a~     reoccurring problem with currently used bone graft substitutes in this subject population. In~     addition, the quality of life before and after implantation will be evaluated as well as the~     bone regeneration around implant.~   "
127403|NCT01899794|"~     The purpose of this study is to determine in female patients who suffer mixed urinary~     incontinence (MUI) the following: 1) the proportion of patients that are cured or improved by~     a single modality therapy (drug or surgery alone), cured or improved by a combined therapy~     (drug and surgery in any order) or non-responders to any of theses therapies; 2) which of the~     combined therapy sequences (surgery first, then followed by oral drug therapy or oral drug~     therapy first, then followed by surgery) is the most effective in patients needing combined~     therapy.~   "
127404|NCT01899781|"~     The investigators assume that simple hand lacerations involving flexors or extensors tendons,~     do not require prophylactic antibiotic treatment to prevent wound infection.~   "
127405|NCT01899768|"~     This study is designed to evaluate the effect of GSK2339345 relative to placebo on the number~     of coughs in patients with Chronic Idiopathic Cough (CIC) administered by an Aqueous Droplet~     Inhaler (ADI). The primary aim is to investigate the efficacy of GSK2339345 on reducing~     objective cough frequency in CIC patients. The secondary aim of this study is to investigate~     the efficacy of GSK2339345 in inhibiting a hypertussive cough response elicited by capsaicin~     and citric acid in CIC patients which have a hyperresponsive cough reflex.~      Following the screening visit, all eligible subjects will attend the unit for dosing at~     Visits 1-7. At Visits 1, 2 and 3 (Part A of the study), subjects will receive two doses of~     either GSK2339345 or placebo, 4 hours apart and will undergo 8 hours of cough monitoring. At~     Visits 4 and 5 (Part B of the study) and Visits 6 and 7 (Part C of the study), subjects will~     be administered a single dose of either GSK2339345 or placebo. Subjects will then undergo~     capsaicin (Part B) or citric acid (Part C) tussive challenge and will undergo cough~     monitoring for 1 hour post dose.~      The maximum study duration will be approximately 11 weeks, including 3 weeks screening and 2~     weeks follow-up. Approximately 30 patients will be randomised into the study, such that~     approximately 24 patients complete dosing and critical assessments.~   "
127406|NCT01899755|"~     GSK2800528 is being developed as a human anti-tumor necrosis factor (TNF) alpha monoclonal~     antibody (mAb) for the treatment of immune-inflammatory diseases. The study will be conducted~     in healthy volunteers and divided into 4 cohorts. Cohorts 1 to 3 will consist of groups of 12~     subjects, 9 on active treatment (GSK2800528), and 3 on placebo. Cohort 4 will consist of a~     group of 9 subjects, all on active treatment (adalimumab).~   "
127407|NCT01899742|"~     The primary objective is to compare the efficacy of UMEC/VI Inhalation Powder (62.5/25 mcg)~     once-daily with tiotropium (18 mcg) once-daily over 12 weeks for the treatment of subjects~     with COPD who have received tiotropium and continue to have symptoms while on tiotropium.~   "
127409|NCT01899716|"~     The study aimed to evaluate the use of exercise as a complementary strategy to treat severe~     major depression in inpatients.~      Hypothesis: Exercise can be used as a safe and efficacious complimentary strategy in severe~     depressed inpatients.~   "
127430|NCT01899443|"~     Primary total knee or total hip replacement surgeries are costly high volume procedures &~     outcomes may be affected by surgical & care processes & individual patient characteristics.~     The primary hypotheses is that non compliance with recommended practice impacts patient~     outcomes (e.g. the likelihood of complications following surgery). The primary aims of the~     study are to evaluate the links between processes & outcomes & if possible develop a model~     that will improve patient outcomes & reduce unnecessary practice variation whilst considering~     costs.~   "
127410|NCT01899703|"~     This will be a randomized, double-blind, placebo-controlled study to assess safety and~     tolerability of GSK2330672 administration in subjects with primary biliary cirrhosis (PBC)~     and symptoms of pruritus. It is a double-blind, crossover study with subjects receiving~     placebo or GSK23306772 in random order during two 14-day treatment periods. Additionally, the~     study will determine GSK2330672 exposure and interactions with ursodeoxycholic acid (UDCA).~     The total duration of subject participation will be 14 weeks for screening (45 days) and the~     treatment period. Subjects who are eligible for enrolment will participate in a 2-week~     placebo run-in period. Subjects will be randomized in a crossover fashion (Sequence 1 /~     Sequence 2) to receive placebo or GSK2330672 treatment during two consecutive 2-week study~     periods. Subjects will then participate in a 2-week placebo dosing follow-up period ending in~     final follow-up assessments. Study results will be utilized to form a benefit: risk profile~     for GSK2330672 in PBC that will determine plans for progression to exploratory efficacy~     trials~   "
127411|NCT01899690|"~     This study is a randomized controlled non-blinded double arm study examining the effect of~     routine postoperative oral antibiotic therapy in preventing postoperative surgical site~     infections after breast reconstruction. The investigators hypothesize that use of~     prophylactic antibiotics after breast reconstruction does not reduce surgical site~     infections.~   "
127412|NCT01899677|"~     The aim of this prospective double blinded randomised study is to investigate the efficacy of~     symbiotic preparation which contains lactobacillus casei, L. rhamnosus, L. plantarum,~     Bifidobacterium lactis, fructo and galactooligosaccharide on cytokines as interferon-gama~     acting on Th1 pathway, interleukin -5 acting on Th2, interleukin -10 acting on T regulatory~     pathway, and interleukin -17 acting on Th-17 pathway that were related with necrotizing~     enterocolitis pathogenesis in very low birth weight neonates.~   "
127413|NCT01899664|"~     The goal of the investigators work is to establish how nerve transfers can be best used to~     improve upper extremity function in patients with cervical level spinal cord injury (SCI).~     The investigators' hypothesis is that nerve transfers are safe and effective and will improve~     function and quality of life in patients with loss of upper function due to spinal cord~     injury. The investigators plan on looking at upper limb function, and health-related quality~     of life in patients before and after surgery to better understand how patients benefit from~     these treatments.~      A nerve transfer procedure can be used to rewire the system to make some muscles work again~     following SCI. The nerve transfer procedure (which is done in the arm and not at the level of~     the spinal cord) can be used to bypass the damaged area and to deliver a signal from the~     brain to a muscle that became disconnected following that injury. A donor nerve is taken from~     another muscle whose use is not essential and then transferred to help in providing more a~     more critical function.~      For example, one type of nerve transfer is done to restore the lost ability to pinch or grasp~     small objects between the fingers that occurs in many patients with cervical SCI. In this~     surgery, a donor nerve that normally helps flex the elbow. This nerve can be used because the~     biceps muscle is also working to flex the elbow. This donor nerve is cut and re-attached to~     the nerve going to muscles in the forearm that provide pinch by bending the tips of the thumb~     and index finger.~      Because the nerve transfer procedure involves cutting and reattaching nerve and muscle~     tissues, time is required to regenerate working connections between the nerves and muscle as~     well as to allow the brain to relearn how to use and strengthen that muscle.~   "
127414|NCT01899651|"~     Dense array EEG and EIT (electrical impedence tomography) are new technologies that can add~     to information needed to diagnose neurological problems in infants - both preterm and term.~     The investigators propose a method to test these technologies in the preterm population to~     determine its safety and ease of use. The investigators will test on preterm infants of 30-34~     weeks gestation, starting first with the older infants (32-34 weeks) then moving down to the~     smaller population (30-32 weeks). In both groups the investigators will start with a short~     time period and gradually extend the time as safety is established.~      All studies will be conducted at Shands Teaching Hospital at the University of Florida.~   "
127415|NCT01899638|"~     This study is to assess the pharmacokinetics (PK), safety and tolerability of UMEC (62.5µg~     and 125µg) and VI (25µg) as monotherapies and combinations in healthy Chinese subjects.~   "
127416|NCT01899625|"~     This study is a 2-arm randomized controlled trial to evaluate the feasibility, acceptability~     and preliminary efficacy of an MI-based program for weight loss in young adults.~   "
127417|NCT01899612|"~     Many postmenopausal women suffer from vaginal symptoms such as dryness, itching, and painful~     intercourse. The underlying pathology is unknown. Since symptoms are comparable to those~     found in infectious vaginitis during the reproductive life stage, the investigators~     hypothesize that the vaginal milieu in symptomatic postmenopausal women is comparable to~     inflammation in vaginitis. The investigators therefore study vaginal cytokines in symptomatic~     and asymptomatic postmenopausal women.~   "
127418|NCT01899599|"~     Efficacy of PankoMab-GEX vs Placebo in maintaining a response to chemotherapy in advanced~     ovarian, fallopian tube or primary peritoneal cancer.~   "
127419|NCT01899586|"~     The aim of this study is to devise a sufficiently high intensity training program that~     provided an optimal stimulus to remove the peripheral factors known to reduce functional~     capacity, and can be cardiovascular and orthopedically well tolerated by the elderly.~     Findings from study laboratories have suggested that a regional specific training stimulus~     (RSTS) results in rapid improvements in both vascular and muscular function. RSTS is a novel~     combination of resistance training and aerobic training applied simultaneously, and in a~     serial manner, to specific regions of the body. It involves high-intensity and frequency~     muscle contractions, generating a targeted exercise stimulus, without producing excessive~     cardiovascular or orthopedic stress. The hypothesis is that initiating training with RSTS at~     multiple, strategically selected peripheral sites, in a serial manner will elicit local~     vascular and muscular changes, thereby preparing individuals at elevated risk of losing~     independence, to respond and progress more favorably to whole-body exercise.~   "
127420|NCT01899573|"~     The study is designed to demonstrate the safety, feasibility and potential efficacy of using~     the AccuCinch® System to reduce functional mitral regurgitation.~   "
127431|NCT01899430|"~     The purpose of this study was to determine whether liraglutide is more effective than~     metformin in the treatment of obese women with newly diagnosed polycystic ovary syndrome~     (PCOS). We anticipated greater changes in body weight in patients treated with liraglutide~     than in those treated with metformin.~   "
127421|NCT01899560|"~     The recruitment strategy in Acute respiratory distress syndrome (ARDS) patients mechanically~     ventilated combines recruitment maneuvers and positive end expiratory pressure (PEEP).~     Recruitment maneuvers promote alveolar recruitment leading to increased end-expiratory lung~     volume in order to prevent repetitive opening and closing of unstable lung units and reduce~     the strain induced by ventilation. In addition, recruitment is effective in improving~     oxygenation. Variety of recruitment maneuver have been described, the most commonly used is~     the application of sustained continuous positive airway pressure at 40 cmH2O for 40 seconds.~     Staircase recruitment maneuver (SRM) is an alternative with good hemodynamic tolerance.~     Staircase recruitment maneuver (SRM) involves a progressive increase in positive end~     expiratory pressure (PEEP) (up to 40 cmH2O), in pressure control ventilation, in order to~     increase end-expiratory lung volume (EELV); then a decreasing PEEP trial is performed. The~     positive end expiratory pressure (PEEP) to prevent alveolar collapse depends on ratio between~     lung elastance and chest wall elastance. If chest wall elastance is high, the PEEP to obtain~     a positive end-expiratory transpulmonary pressure is high. The only way for the time being to~     know the transpulmonary pressure and the ratio between lung and chest wall elastance is the~     use of esophageal catheter. A non-invasive method for measuring the lung elastance by~     measuring volume recruited during a change of pressure (∆PEEP/∆EELV) could be used to avoid~     the use of esophageal catheter.~   "
127422|NCT01899547|"~     The purpose of this study is to evaluate the safety and oncological feasibility of~     laparoscopy-assisted surgery for low rectal carcinoma compared with open surgery.~   "
127423|NCT01899534|"~     To compare e-screening versus usual screening on: 1) women's and healthcare providers' views~     on feasibility and acceptability; 2) rates of detection of prenatal and postpartum depression~     and anxiety; 3) perceived risk and benefit of disclosure; 4) cost-effectiveness; 5)~     psychometric properties. We also aim to identify factors associated with feasibility of~     e-screening.Compared to usual screening:1) e-screening is as feasible; 2) e-screening yields~     similar rates of prenatal and postpartum depression and anxiety; 3) the mean score for risk~     of disclosure is significantly lower and benefit of disclosure is significantly higher in the~     e-screening group; 4) e-screening is as or more cost effective in detecting prenatal and~     postpartum depression and anxiety; 5) features of e-screening are significantly associated~     with feasibility and acceptability, whereas demographic factors are not; and 6) reliability~     and validity indices of ALPHA and EPDS are strongly correlated for both administration modes.~   "
127424|NCT01899521|"~     This is a randomized, placebo controlled trial of dietary zinc and S-adenosylmethionine~     (SAMe) in otherwise healthy alcoholic US Veterans. The primary goal is to determine if either~     dietary zinc or S-adenosylmethionine (SAMe) can augment lung immune defenses in alcoholics~     and thereby decrease the risk of lung injury and infection.~   "
127425|NCT01899508|"~     This study is looking at whether virtual reality combined with pain coping skills training~     helps reduce pain in people who suffer from OA of the knee. Eligible participants will be~     asked to come into the study offices for one visit where they will fill out a couple of~     questionnaires, do some low impact performance tasks and be taught pain coping skills while~     looking into a 3D virtual reality viewer.~   "
127426|NCT01899495|"~     Previous studies have demonstrated that single nucleotide polymorphisms (SNPs) of the~     sodium-bicarbonate co-transporter gene (SLC4A5) are associated with hypertension. We tested~     the hypothesis that SNPs in SLC4A5 are associated with salt sensitivity of blood pressure in~     185 whites consuming an isocaloric constant diet with a randomized order of 7 days of low~     sodium (Na+) and 7 days of high Na+ intake. Salt sensitivity was defined as a ≥7-mm Hg~     increase in mean arterial pressure during a randomized transition between low and high Na+~     diet.~      A total of 35 polymorphisms in 17 candidate genes were assayed, 25 of which were tested for~     association. Association analyses with salt sensitivity revealed 3 variants that associated~     with salt sensitivity. Of these, 2 SNPs in SLC4A5 (rs7571842 and rs10177833) demonstrated~     highly significant results and large effects sizes, using logistic regression. These 2 SNPs~     had P values of 1.0×10−4 and 3.1×10−4 with odds ratios of 0.221 and 0.221 in unadjusted~     regression models, respectively, with the G allele at both sites conferring protection. These~     SNPs remained significant after adjusting for body mass index and age (P=8.9×10−5 and~     2.6×10−4 and odds ratios 0.210 and 0.286, respectively). Furthermore, the association of~     these SNPs with salt sensitivity was replicated in a second hypertensive population.~     Meta-analysis demonstrated significant associations of both SNPs with salt sensitivity~     (rs7571842 [P=1.2×10−5]; rs1017783 [P=1.1×10−4]).~      In conclusion, SLC4A5 variants are strongly associated with salt sensitivity of blood~     pressure in 2 separate white populations.~   "
127427|NCT01899482|"~     The purpose of this study is to compare functional status and quality of life of a group of~     patients with chronic venous insufficiency treated with manual lymphatic drainage with a~     group not treated with manual lymphatic drainage.~      Investigators hypothesized that manual lymphatic drainage can improve:~        -  quality of life,~        -  functional status,~        -  calf muscle strength,~        -  ankle range of motion,~        -  edema,~        -  severity of disease,~        -  and symptoms.~   "
127428|NCT01899469|"~     Aim: To evaluate and compare the effectiveness of a combined treatment of TENS or~     Elec-tromagnetic and Back School with the effectiveness of only the Back School treatment.~      Design: Single-blind experimental prospective study of clinic intervention. Setting:~     Physiotherapy and Speech Therapy Unit at the Cambrils Slight Hospital. Spain.~      Population: 96 women (50-85 years) with chronic low back pathology. Methods: Subjects were~     divided into three randomized groups: Back School (group 1), TENS with Back School (group 2),~     and Magnetic therapy with Back School (group 3). They have re-ceived 20 sessions of~     treatment. The intensity of pain (EVA Scale) and the quality of life (Oswestry Scale) were~     measured, at the beginning and at the end of the treatment and after three and six months.~     Anthropometric and physical activity variables were collected.~   "
127429|NCT01899456|"~     The study is aiming to document the safety and effectiveness of renal denervation in patients~     after renal transplantation with hypertension. Catheter-based renal denervation will be~     performed using CE marked, percutaneous Symplicity catheter.~   "
127432|NCT01899417|"~     The purpose of this study is to evaluate the costs and benefits of the ConforMIS iTotal®~     total knee replacement system versus standard total knee arthroplasty.~      This study is designed to illustrate the difference in cost between standard total knee~     replacements and the ConforMIS iTotal at a single institution.~   "
127433|NCT01899404|"~     The standard treatment for cervix cancer at Princess Margaret Hospital is external radiation~     with chemotherapy followed by internal radiation, called brachytherapy. Currently,~     brachytherapy treatment is planned on a type of Magnetic Resonance Imaging (MRI) called~     T2-weighted (T2W) MRI.~      The main purpose of this study is to determine whether the following imaging tests can~     visualize the tumor better for planning the brachytherapy treatment:~        1. special types of MRI called diffusion weighted MRI (DWI) and dynamic-contrast enhanced~          MRI (DCE-MRI); and~        2. an x-ray test called positron emission test (PET) performed with a sugar dye called FDG.~          MRI-guided brachytherapy is resource-intensive and not widely available.~   "
127434|NCT01899391|"~     Right now it is not possible to predict which patients are going to react more to RT. Many~     things could affect patient's response to radiation. One of the factors is whether the person~     can repair damage to the genetic material (DNA/RNA) caused by the RT. There is some evidence~     that a certain protein called Gamma H2AX is involved in DNA damage and repair and this can be~     used to predict the sensitivity of individual patients. The investigators will be studying~     this protein: Gamma H2AX) in the blood samples of prostate cancer patients exposed to both~     computed tomography (CT) scan and RT treatment. This will help us to understand why different~     individuals show differences in side effects following RT.~   "
127435|NCT01899378|"~     Here the investigators propose to preliminarily investigate the safety and effects of~     probiotics in infants in Bangladesh through a pilot randomized clinical trial. The~     investigators hypothesize that two probiotics are safe for infants in Bangladesh and may have~     an effect on biomarkers of gut health and immunity. The specific aims of this pilot are: i)~     to confirm the safety of administering probiotic strains to infants in low-income countries,~     ii) to determine the effects of dosing frequency on colonization and persistence of~     probiotics in the GI tract, iii) to measure markers of intestinal and immune function and~     microbiota structure.~   "
127436|NCT01899365|"~     Background :~      Community-acquired pneumonia (CAP) is a threat in industrialized countries. It represents the~     6th cause of death. CAP also frequently associates with other disorders responsible for~     admission and death. Among bacteria responsible for CAP, Streptococcus pneumonia is a major~     pathogen that is commonly involved and frequently leads to severe infection and admission.~     Categories at risk for this pathogen have been determined, and can be proposed~     anti-pneumococcal vaccination (APV) that efficiently and safely protects from this~     microorganism.~      In the context of US health services, monocenter pilot experiences have reported improvement~     of pneumococcal prophylaxis implementing vaccination procedure at ED. A study that set in New~     Mexico (2003) reported a significant increase in APV (from 18% to 84%) when patients at risk~     were proposed vaccination at ED. To obtain these results, medical students were specifically~     trained and dedicated to screen and vaccinate against St. pneumoniae. Another single center~     trial (Tennessee, 2007) for APV at ED obtained an improvement (from 38.8 to 45.4%) when~     physicians were alerted for pneumococcal risk by the software they usually utilized at~     bedside. However these experiences remain sparse as additional dedicated resources are~     required or patients and attending ED physicians can be reluctant to proceed to vaccination~     at ED.~      Mobile phone and derived communication modalities are current vectors to deliver information~     in several fields including education and medicine. Initially used in developing countries,~     short-message services (SMS) have improved behaviour of patients in various medical areas. In~     France, the investigators have observed that most patients above 50 years of age admitted~     after ED visit are equipped with mobile phone and can receive alerts by SMS.~      These observations prompt us to propose a multifaceted procedure to improve APV after ED~     visit in at-risk patients, combining structured oral interview, written information and SMS~     as reminders.~      Purpose : The investigators hypothesized that~        -  a multifaceted intervention to promote anti-pneumococcal vaccination combining a~          structured oral interview, a written information to patient and his/her general~          practitioner, and a series of 3 SMS,~        -  improves anti-pneumococcal vaccination at 6 months,~        -  in at-risk patients (65+ years) visiting the emergency department. In order to answer~          this question, the investigators designed an interventional prospective multicenter~          randomized study (cluster).~   "
127437|NCT01899352|"~     Tracheostomy is worldwide used for critically ill patients. The aim of our study is to assess~     the mortality, quality of life, laryngeal function, procedures, early and late complications~     of tracheostomy performed for critically ill patients admitted in intensive care units.~   "
127438|NCT01899339|"~     Patients with Submassive Pulmonary Embolism treated with ultra-sound therapy will have an~     improved right ventricular function 72 hours post treatment.~   "
127439|NCT01899326|"~     This pilot clinical trial studies how well desipramine hydrochloride and filgrastim works for~     stem cell mobilization in patients with multiple myeloma undergoing stem cell transplant.~     Giving colony-stimulating factors, such as filgrastim, and other drugs, such as desipramine~     hydrochloride, helps stem cells move from the patient's bone marrow to the blood so they can~     be collected and stored.~   "
127440|NCT01899313|"~     This Phase I behavior therapy development study seeks to improve treatment outcomes for~     methamphetamine (MA)-dependent subjects by developing a novel cognitive behavioral therapy-~     (CBT-) based short message service (SMS) text messaging intervention.~   "
127441|NCT01899300|"~     The purpose of this study is to establish clinical proof of concept of temporary indwell of~     the WallFlex™ Esophageal Fully Covered Metal Stent (FCMS) for the treatment of refractory~     benign esophageal strictures caused by caustic ingestion.~   "
127442|NCT01899287|"~     Occupational hand eczema (OHE) is a frequent disease which often takes a chronic course. The~     burden of the disease is high in a personal as well as in a socio-economic context. There is~     a need for evaluating new strategies to improve the prognosis for OHE patients. The~     objectives of the study is to evaluate the effect of group education on sick lave,~     health-related quality of life and disease severity among individuals with newly notified~     OHE.~      The trial population consist of individuals from the Capital Region of Denmark and Region~     Zealand with a suspected skin-related industrial injury notified to the Danish National Board~     of Industrial Injuries (DNBII). Recruitment is started Juli 2012, and will continue until the~     designed number of participants have been included.~      All participants will be assessed in a questionnaire at time T=0 with regard to: self~     evaluated disease severity, health-related quality of life, skin protective behaviour,~     knowledge of skin protection, self-efficacy, work-role function and if active in workforce.~     The participants will then be randomised. The intervention group will be invited to~     participate in the educative course, and work place visits will be offered. In the~     intervention group a telephone hot line will be available for further questions concerning~     these topics. The control group will not have access to any of these interventions. Both~     intervention group and control group will be contacted every eighth week about number of days~     of sick leave/absence from workforce. Both groups are re-assessed using a questionnaire at~     T=12 months. There will be a total of 742 included participants.~   "
127443|NCT01899274|"~     The purpose of the study is to assess whether an electronic self-management tool,~     specifically an iPhone application entitled bant, can improve glycemic control in Adolescents~     who have Type 1 Diabetes Mellitus (T1DM).~   "
127450|NCT01899183|"~     The effectiveness of surgical fundoplication in treating classical reflux symptoms is well~     documented, but the role of surgery in alleviating extra-esophageal symptoms allegedly~     secondary to gastro-esophageal reflux disease (GORD) is far to be assessed.~      The effectiveness of anti-reflux surgery on extra-esophageal reflux symptoms varies from 15%~     to 95%; the spread of these data is largely attributable to disparate study design and~     methodology, patient selection, and outcome metrics.~      In order to assess whether anti-reflux surgery may have beneficial effects on chronic cough~     allegedly secondary to GERD and to eventually identify the preoperative clinical profile~     which could predict those positive effects, we considered two groups of patients presenting~     with 1) GERD associated to chronic cough, 2), typical GERD who underwent anti-reflux surgery.~   "
127451|NCT01899170|"~     Chronic neuropathic pain affects millions of individuals worldwide. It causes marked~     reduction of health, utility and quality of life and represents a considerable economic~     burden to society due to loss of work capacity and large treatment expenses. The proposed~     project will explore new and rational methods for deep brain stimulation treatment of~     patients with severe chronic neuropathic pain, resistant to conventional treatment. Deep~     brain stimulation is a neurosurgical procedure in which a small stimulating electrode is~     implanted into deep brain areas. Furthermore, we will utilize new positron emission~     tomography neuroimaging and a new prototyped technology, called targeted transcranial~     magnetic stimulation, to predict the outcome of deep brain stimulation and localize brain~     regions with maximum symptom relief for each patient. This will optimize the selection of~     patients for deep brain stimulation and provide a rational customized choice of brain target~     for each patient, without surgical intervention. Novel techniques will be validated on~     healthy volunteers and at the same time provide new insights into the mechanisms underlying~     brain stimulation and pain perception. The project has great clinical impact, potential for~     innovative development and industrial spin-out, facilitates exchange for Danish research~     talents and senior researchers with Stanford University and California Pacific Medical~     Research Institute in San Francisco, and unites world leading experts in pain research and~     clinical treatment to achieve its goals.~   "
127452|NCT01899157|"~     A prospective cross-sectional study evaluates nutritional status and its relationship to the~     related factors in Thai HIV-infected patients who attending in out patient clinic.~   "
127453|NCT01899144|"~     This is a multicenter, randomized, double-blind, double-dummy, placebo-controlled,~     single-dose, 5-treatment, 5-period, 5-way crossover study in pediatric patients with~     persistent asthma. The primary purpose of this study is to compare the efficacy and safety of~     Albuterol Spiromax with that of ProAir HFA in pediatric asthma patients at 2 delivered dose~     levels equivalent to 90 mcg and 180 mcg of albuterol base.~   "
127454|NCT01899131|"~     1. To investigate the hard and soft tissue adaptation and maintenance to the Laser-Lok®~          microchannels permanent abutment/ new Laser-Lok® implant assembly by performing clinical~          and radiographic evaluations.~        2. To investigate the effect of inter-implant spacing (minimum of 2 or 3 mm) on hard and~          soft tissues.~        3. To perform clinical and radiographic evaluations on these abutment/implant assemblies up~          to 2 years.~   "
127455|NCT01899118|"~     Neoadjuvant (preoperative) concomitant chemoradiotherapy (CRT) is now considered as a~     standard treatment of locally advanced rectal adenocarcinomas, which correlates better local~     control and higher sphincter preservation rate. Nimotuzumab, a humanized monoclonal antibody~     against epidermal growth factor receptor (EGFR) has been reported to improve the therapeutic~     effect of radiotherapy in some cancers. This study is a clinical phase II trial designed to~     evaluate the efficacy of the combination of Nimotuzumab administered concurrently with~     neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancer, and to further~     investigate its side-effect and toxicity.~   "
127456|NCT01899105|"~     This study is designed to investigate the effect of food on the relative bioavailability of 2~     different strengths of fixed-dose combinations of lumacaftor and ivacaftor tablet~     formulations.~   "
127457|NCT01899092|"~     The study is a first in man, dose escalation study that will measure the safety and efficacy~     of TT-034 in the treatment of patients with chronic hepatitis C. The study is divided into 5~     dose levels. Subjects will be given a single dose delivered by IV infusion. The subjects will~     be monitored and the data analyzed. After a set time, between 6 and 10 weeks depending on the~     dose level, the next set of subjects will be dosed. The study drug is a gene therapy~     treatment that produces molecules that destroy the Hepatitis C virus (HCV) in infected cells.~     Once the study drug is given, it cannot be withdrawn. Additionally, once an individual~     receives a dose, he or she will not be able to receive a second dose, but will remain~     eligible to receive most other HCV treatments.~   "
127458|NCT01899079|"~     The primary objective of this study is to assess the extent to which the Prosigna™ Breast~     Cancer Prognostic Gene Signature Assay affects the medical oncologist's treatment~     recommendations regarding adjuvant chemotherapy and actual treatments received for patients~     with early-stage breast cancer.~   "
127459|NCT01899066|"~     This study will evaluate the clinical efficacy of intravitreal injections of Ranibizumab~     (Lucentis) together with chemotherapy in the treatment of Retinoblastoma as compared to~     chemotherapy alone.~   "
127460|NCT01899053|"~     This study is a multicenter, open-label, phase 1b trial of MLN0128 (an oral mTORC1/2~     inhibitor) in combination with MLN1117 (an oral inhibitor of the PI3K (alpha) isoform) when~     administered to adult patients with advanced nonhematological malignancies.~   "
127461|NCT01899040|"~     This is a randomized, blinded study designed to assess the efficacy of a portable,~     non-invasive neuromodulation system for the treatment of episodic migraine headaches.~   "
127462|NCT01899027|"~     The primary objective of this study is to test the hypothesis that twice overnight high-dose~     rosuvastatin loading before RNA followed by 3-month treatment with regular doses of~     rosuvastatin can reduce both the acute and late renal artery damage.~   "
127463|NCT01899001|"~     The purpose of this study is to help determine the best treatment plan for women with PCOS~     who are overweight or obese and experiencing significant symptoms of depression and anxiety.~      Specifically, the investigators are attempting to see if there is a difference between~     cognitive behavioral therapy in combination with nutritional counseling in improving mood~     symptoms, response to stress, and risk factors for heart disease compared to nutrition~     counseling alone. The investigators hypothesize that combined treatment with Cognitive~     Behavioral Therapy (CBT) and nutritional counseling will be more beneficial.~   "
127464|NCT01898975|"~     Optimal fluid management has been considered as crucial part to determine postoperative~     outcome and organ function. Recently developed, non invasive cardiac output~     measurement(NICOM, Cheetah Medical, Portland, OR)has enabled continuous cardiac output(CO)~     monitoring just by attaching electrode on chest wall. Moreover, CO and SSV derived from NICOM~     have been demonstrated as predictors of fluid responsiveness. Therefore, the aim of this~     study is to evaluate stroke volume variation derived from NICOM as a predictor of fluid~     responsiveness in neurosurgical patients. In addition, we plan to reveal inconclusive~     patients using gray zone approach.~   "
127465|NCT01898962|"~     Patients with metastatic cancer are usually treated with systemic therapy (treating the~     entire body) with the assumption that any localized treatment of clinically apparent~     metastases would not impact survival. In the setting of increasingly effective systemic~     therapy and limited metastatic disease, aggressive treatment to clinically active sites of~     disease (alone or in addition to systemic therapy) may improve survival.~   "
127466|NCT01898949|"~     Human fat tissue is essentially white fat, the main function of which is to store excess~     energy intake, and to release it when necessary. Brown fat is far less abundant and is~     present in the body to burn fat (and thus energy) to generate heat to maintain body~     temperature around 96 degrees. This phenomenon is called thermogenesis. When humans are~     exposed to cold on a chronic basis, brown fat expands and becomes more active, and~     consequently burns more energy. The amount of brown fat is higher during winter, and daily~     short (20 minutes) exposures to cold might be sufficient to induce its activity.~      We hypothesized that daily short term (20 minutes) exposure to a cold environment (4 °C) for~     four weeks increases adaptive BAT-mediated thermogenesis. CIT and DIT will be increased~     proportionally (the increase in CIT and DIT will be correlated).~   "
127467|NCT01898936|"~     Organ transplant recipients (OTR) have an increased risk of non-melanoma skin cancer, in~     particular squamous cell carcinoma (SCC), often developing in areas of field cancerization,~     areas with multiple precancerous actinic keratoses. The risk of developing SCC in OTR is~     65-100-fold the normal population (Jensen 1999, Lindeløf 2000), and this cancer often runs a~     more aggressive course with metastasis reported to occur in 5-8% of cases (Berg 2002). The~     treatment options in field cancerization are limited. In Norway, the registered treatment~     alternatives are the topical immune response modifier imiquimod and photodynamic treatment.~     Neither of these treatments has shown long term beneficial effects.~      In this study, we will study the effect of pre-treating the skin with ablative, fractional~     carbondioxide laser before photodynamic therapy in a group of OTR with multiple actinic~     keratoses~   "
127468|NCT01898923|"~     The primary objective of this study is to evaluate the efficacy of the new treatment of WH-1~     ointment compared to Aquacel® Hydrofiber® dressing, applied to chronic diabetic foot ulcers~     for up to 16 weeks.An additional objective of this study is to collect safety information~     including adverse events and clinical laboratory abnormalities.~   "
127469|NCT01898910|"~     The investigators have conducted a prospective, double-blind, randomized study to assess the~     comparative safety and efficacy of two different strategies, PVI plus Renal Denervation (RD)~     versus PVI plus GP ablation, in patients with atrial fibrillation. Results were assessed~     after follow-up of at least 1 year with the use of an implanted monitoring device (IMD).~   "
127470|NCT01898897|"~     The study hypothesis is that regional anesthesia offers better outcome for the patients who~     underwent robot assisted laparoscopic urogenital surgery.~   "
127471|NCT01898884|"~     The objectives of the study are:~        -  To evaluate the safety and tolerability of single and multiple oral doses of VP 20629 in~          subjects with Friedreich's ataxia (FA). [Primary]~        -  To characterize the pharmacokinetics of VP 20629 by investigation of the plasma~          concentration-time profile following single and multiple oral doses in subjects with FA.~          [Secondary]~        -  To investigate the pharmacodynamic effects of VP 20629 on plasma 8-isoprostane and~          malondialdehyde and urinary 8-hydroxydeoxyguanosine concentrations following multiple~          oral doses in subjects with FA. [Exploratory]~   "
127472|NCT01898871|"~     The purpose of this study is to determine whether an improved corn-soya blend (CSB+) and a~     new formulated ready-to-use supplementary food (RUSF) are effective in the treatment of~     moderate acute malnutrition in children.~   "
127473|NCT01898858|"~     The aim of this study is to describe the pulmonary hemodynamic evolution at rest and during a~     short constant load exercise in 4 conditions :~        -  normoxia~        -  hypoxia~        -  hypercapnia~        -  association hypoxia and hypercapnia~   "
127474|NCT01898845|"~     This study will evaluate safety and tolerability to estimate the MTD and/or recommended dose~     for expansion.~   "
127475|NCT01898832|"~     The aim of this study is to investigate maternal and fetal serum IL-17 levels in pregnant~     women with intrahepatic cholestasis of pregnancy and to find out if Th-17 cells have a role~     in progress of intrahepatic cholestasis of pregnancy.~   "
127476|NCT01898819|"~     Intraocular pressure is significantly increase during robot-assisted laparoscopic radical~     prostatectomy which is performed in a steep trendelenburg position at prolonged timeds of~     pneumoperitoneum. Threrefore we decided to evaluate the effect of dexmedetomidine in~     intraocular pressure during roboti-assisted laparoscopic radical prostatectomy.~   "
127477|NCT01898806|"~     This study aims to determine the frequency of response to treatment with 3 concentrations of~     IL TAC, 2.5mg/ml, 5mg/ml or 10mg/ml as well as the duration of response and incidence of side~     effects compared to treatment with placebo (sterile saline solution). After the 1st 6 months,~     nonresponders or partial responders may be treated for 6 months with open label triamcinolone~     at the dose deemed appropriate by the investigator.~      The investigators will also perform skin biopsies of the scalp and draw blood at selected~     time points in order to examine the immunohistochemical/pathological response in scalp hair~     follicles and the systemic circulation to treatment with IL TAC for alopecia areata.~   "
127511|NCT01898364|"~     Primary Objective:~      To evaluate the safety and tolerability of neoGAA in treatment naïve and alglucosidase alfa~     treated late-onset Pompe disease patients.~      Secondary Objective:~      To evaluate the pharmacokinetics, pharmacodynamics of neoGAA in treatment naïve and~     alglucosidase alfa treated late-onset Pompe disease patients.~      To evaluate the effect of neoGAA on exploratory efficacy endpoints in treatment naïve and~     alglucosidase alfa treated late-onset Pompe disease patients.~   "
127478|NCT01898793|"~     This phase I/2 trial studies the side effects and best dose of activated natural killer cells~     in treating patients with relapsed or refractory acute myeloid leukemia and myeloid~     dysplastic syndromes. Giving chemotherapy before a donor natural killer cell infusion helps~     stop the growth of cancer cells. It may also stop the patient's immune system from rejecting~     the donor's natural killer cells. Modified natural killer cells may help the body build an~     immune response to kill cancer cells. Aldesleukin (interleukin-2) may stimulate the white~     blood cells (including natural killer cells) to kill leukemia cells.~      In the phase II portion of the study, the investigators intend to use maximal tolerated or~     tested (MT/TD) CIML NK cell dose as determined from the phase I part of this study. The phase~     II portion of the study also replaces IL-2 with ALT-803. The rationale for this change is to~     support the donor derived NK cells in vivo after adoptive transfer.~   "
127479|NCT01898780|"~     The aim of this study is to verify that the frequency of pancreatic fistula (ISGPF grade B~     and C) in horizontal mattress suture are lower than in interrupted suture during~     pancreaticojejunostomy in pancreatoduodenectomy by randomized clinical trial.~   "
127480|NCT01898767|"~     The long-range goal of this protocol is to more completely understand the risks and the~     pathophysiology of asthma exacerbations, in order to develop prevention strategies and/or~     expedite a return to complete control of baseline asthma symptoms.~   "
127481|NCT01898754|"~     The investigators propose to gauge improvements in the rate of durable suppression of viral~     replication by ART when OLA is used to guide clinical decisions at the PEPFAR Coptic Hope~     Center in Kenya, and to determine the cost-effectiveness of implementing this strategy at~     Coptic Hope Center.~   "
127482|NCT01898741|"~     Pancreatic cancer has a very poor survival, due to late diagnosis and lack of sufficient~     treatment options for locally advanced tumors and metastasized patients. High dose~     radiotherapy with small margins seems feasible with current technical possibilities, e.g. by~     fiducial guided stereotactic radiotherapy. In this study, we want to evaluate safety and~     technical feasibility for cone beam CT guided stereotactic radiotherapy for locally advanced~     pancreatic carcinoma.~   "
127483|NCT01898728|"~     The eye contains a lens that focuses light. A clouding of the lens is known as a cataract.~     Cataracts decrease vision. The treatment for cataracts is cataract surgery. Cataract surgery~     is one of the most commonly performed surgical procedures. Although rare, complications of~     cataract surgery are significant given the number of people who have surgery each year and~     more serious complications may have a significant impact on the vision and quality of~     patients. Endophthalmitis is an infection in the eye and it is one of the worst complications~     of cataract surgery. Most of these infections are caused by bacteria from the patient's skin~     and conjunctiva, which makes cleaning the skin and eye before surgery very important. Before~     cataract surgery, patients receive an umber of eye drops; many surgical centers have a~     combination of medications in a thick gel, so that the medications remain in the eye for a~     long period of time, which may improve their effect. Laboratory studies suggest that the~     antibacterial effect of cleaning solutions may be inhibited by gels but this has not been~     proven, and many believe it to be untrue. This study is to compare the amount of bacteria on~     the eye prior to surgery in patients receiving a gel formulation of the medications before~     surgery as compared to those receiving the same medication in eye drop (liquid) form.~   "
127484|NCT01898715|"~     This first-in-human study is designed to establish the safety and tolerability of ATR-101 in~     patients with advanced adrenocortical carcinoma whose tumor has progressed on standard~     therapy. Information will also be collected to determine how long ATR-101 stays in the blood,~     and if any effect on tumor progression is seen. Biomarkers (blood and urine tests) will~     determine if any effects on production of steroid hormones (cortisol, aldosterone, estrogen~     and testosterone) are seen.~   "
127485|NCT01898702|"~     The purpose of this study is to determine whether participation in a diabetes expert patients~     programme course is effective in self-management of a chronic condition such as diabetes, if~     it reduces Haemoglobin A glycosylated levels, improves patient's quality of life, and~     prevents the use of some health services.~   "
127486|NCT01898689|"~     A continuous peripheral nerve block—also termed perineural local anesthetic~     infusion—involves the insertion of a tiny tube (a catheter) through the skin and adjacent~     to a peripheral nerve, followed by local anesthetic (numbing medicine) administration via the~     catheter, providing pain control following surgery. Continuous peripheral nerve blocks may be~     provided in the hospital setting, but the use of lightweight, portable pumps permits infusion~     at home as well. However, it remains unknown if the concentration of the local anesthetic~     influences the block effects; or, is it rather simply the total dose of medication that is~     important. If it is the latter, then the concentration of local anesthetic could be~     increased, allowing a decreased basal infusion rate, which would allow patients at home to~     receive twice the duration of potent pain control since their infusion pump local anesthetic~     reservoir would last twice as long as current practice. In addition, if one~     concentration/dose combination results in less muscle weakness, but with at least equivalent~     analgesia, then the risk of falling might be decreased as well.~      The investigators will test the hypothesis that providing ropivacaine at different~     concentrations and rates (0.1% at 8 mL/hour vs. 0.4% at 2 mL/hour)—but at an equivalent total~     basal (8 mg/hour)—produces comparable effects when used in a continuous popliteal-sciatic~     nerve block.~   "
127487|NCT01898676|"~     A study in stable epilepsy patients comparing levels of valproic acid after administration of~     brand and generic divalproex sodium extended release tablets.~   "
127488|NCT01898663|"~     The aim of this Phase Ⅰ/Ⅱ study is to evaluate the safety and efficacy of dendritic cells~     (DCs) vaccine combined with cytokine-induced killer (CIK) cells in patients with high-risk~     soft tissue sarcoma. Experimental recombinant adenovirus-transfected DCs, which engineered to~     express MUC1 and Survivin are used for DCs-based immunotherapy. Based on the results of our~     previously performed preclinical study with DCs vaccine combined with CIK cells, the~     investigators plan to perform the clinical trial.~   "
127529|NCT01898130|"~     This is a study to evaluate a drug called bevacizumab in patients with cancer whose disease~     has spread to their brain. This study will not evaluate the effect of bevacizumab on the~     systemic solid tumor cancer. Bevacizumab is a medication and it is thought that bevacizumab~     may interfere with the growth of new blood vessels; therefore it might stop tumor growth and~     possibly shrink the tumor by keeping it from receiving nutrients and oxygen supplied by the~     blood vessels.~   "
127489|NCT01898650|"~     Craniosynostosis is a birth defect that causes the bones on a baby's head to fuse together~     earlier than normal. This causes the baby to have an abnormally shaped head. These children~     are operated on to prevent or treat increased pressure on the brain, allowing for normal~     development. There is not good evidence of which children with craniosynostosis have~     increased pressure on the brain. Up to twenty patients with craniofacial abnormalities will~     be enrolled in this pilot study. The investigators will use a magnetic resonance scanner to~     obtain several measures of brain metabolism. The investigators will also obtain data which~     are markers of developmental delay.~      The results will also be compared to age and gender matched data from children without~     craniofacial abnormalities.~      There study hypothesis is that patients with craniofacial abnormalities associated with~     intracranial pressure will have decreased metabolic activity compared to control patients.~   "
127490|NCT01898637|"~     The goal of this project is to determine if the change in oxygen saturation during deep~     inspiration (augmented pulse oximetry) can be used as a method to rule out pulmonary~     embolism (PE). The investigators propose to evaluate a simple, non-invasive clinical tool to~     help rule out PE. The investigators plan to measure the oxygen saturation of 40 consecutive~     patients with newly-diagnosed PE (within 60 minutes of diagnosis) and 80 matched controls who~     do not have a PE. Trained, blinded Respiratory Therapists or Study Coordinators will record~     each patient's oxygen saturation before, during, and after a 2-minute period of deep~     inspirations (vital capacity [the maximal amount of air that can be inhaled, measured in~     milliliters]) using an incentive spirometer. The investigators' central hypothesis is that~     persons with a PE will not respond to augmented pulse oximetry and will not significantly~     improve or normalize their oxygen saturation.~   "
127491|NCT01898624|"~     To investigate the effects of mirabegron on the symptoms of glaucoma in overactive bladder~     (OAB) patients with coexisting glaucoma.~   "
127492|NCT01898611|"~     Frailty is a geriatric syndrome leading to physical deterioration including muscle wasting~     (sarcopenia) and unintentional weight loss. There are currently no approved therapies for~     frailty. Ghrelin is a hormone produced by the stomach that stimulates appetite centers in the~     brain. The investigators already know that a single dose of Ghrelin improves food intake~     immediately after the dose in frail older people. In addition, exercise programs have been~     shown to improve strength and function in older people. In this study, the investigators are~     trying to find out if a joint intervention of ghrelin and resistance training will improve~     walking, balance and leg strength in frail elderly people.~   "
127493|NCT01898598|"~     This randomized, double-blind, placebo-controlled study will assess the efficacy and safety~     of vismodegib with surgery in participants with basal cell carcinoma.~   "
127494|NCT01898585|"~     This open-label, single-arm, multicenter study will assess the safety and efficacy of~     Zelboraf (vemurafenib) in patients with Braf V600 mutation positive metastatic melanoma.~     Patients will receive Zelboraf 960 mg twice a day until progressive disease, unacceptable~     toxicity, consent withdrawal, death, reasons deemed by the treating physician or study~     termination.~   "
127495|NCT01898572|"~     It has been hypothesized, based on recent trials, that only early intervention can reduce~     cardiovascular morbidity and mortality in individuals with type 2 diabetes (T2DM). This~     finding may imply that atherosclerosis at diabetes diagnosed, is either negligible, or at~     early, or non-advanced, still modifiable disease stage. However, sparse information is~     available regarding atherosclerosis prevalence and its characteristics at diabetes~     presentation. Furthermore, although cardiovascular disease (CVD) prevention is the major goal~     of treatment in T2DM, risk assessment tools, mostly based on traditional CV risk factors,~     lack of adequate specificity to identify individuals at higher risk. Therefore, non-invasive~     tests, such as carotid ultrasound, have been recommended to better define CV risk in several~     groups of individuals, including those with intermediate risk or with T2DM.~      This clinical study aims to improve the investigators knowledge on cardiovascular disease~     (CVD) in subjects with newly diagnosed T2DM (NEWDM). The investigators hypothesis is that~     carotid ultrasound (carotid intimae media thickness [CIMT] and carotid plaque [CP]) will show~     a worse subclinical/preclinical CVD stage in NEWDM compared with non-diabetic (CONTROL)~     individuals. Moreover, carotid ultrasound will also identify T2DM individuals at a higher~     risk in whom intervention should be more intensive.~      Because individuals with T2DM have a higher prevalence of several CV risk factors, NEWDM will~     be matched with CONTROL individuals, not only for age and sex (the main determinants of~     atherosclerosis), but also for known, treated hypertension and dyslipidemia, and smoking~     habit.~      The investigators will study NEWDM and CONTROL individuals without clinical CVD. This is a~     cross-sectional and longitudinal (18 months of follow-up) case-control study. The main study~     variables will be carotid ultrasound derived variables. The main aims of the study are: 1) to~     investigate CIMT and CP prevalence differences between NEWDM and CONTROL subjects; 2) to~     characterize the subset of NEWDM subjects with a higher CIMT (≥ mean+1SD o ≥ P75th) or CP~     presence; and 3) to early characterize individuals in whom subclinical CVD worsens (CIMT~     progression ≥ mean + 1SD o ≥ P75th) even after standard (according to clinical guidelines)~     diabetes treatment.~   "
127496|NCT01898559|"~     This study examines the effects of smoking little cigars in different groups of smokers. The~     investigators are focusing on differences in how smokers' bodies break down and eliminate~     nicotine from their systems. Some people are fast metabolizers of nicotine, meaning they~     break down and eliminate nicotine from their bodies more quickly. Other people are slower~     metabolizers meaning they break down and eliminate nicotine more slowly. The investigators~     are comparing these two groups of smokers when they switch to smoking cigars instead of~     cigarettes.~   "
127497|NCT01898546|"~     Objectives. We will evaluate the effect of ischemic postconditioning (PCON) on microvascular~     obstruction (MVO) in patients with a first ST-segment elevation myocardial infarction (STEMI)~     treated with primary angioplasty.~      Background. PCON appears as a potentially beneficial tool in STEMI. Its impact on MVO is~     unknown.~      Methods. In a multicenter study, 132 patients with a first STEMI will be randomized to~     undergo primary angioplasty followed by PCON or primary angioplasty alone (non-PCON). MVO and~     infarct size (IS) will be quantified (% of left ventricular mass) in a core laboratory~     analyzing late enhancement cardiovascular magnetic resonance imaging.~   "
127498|NCT01898533|"~     In this study, investigators intend to measure changes in BOLD contrast in the breast induced~     by breath-holding for subjects receiving radiation therapy to the breast. This study will~     provide the preliminary data and experience needed to successfully apply BOLD to quantify~     changes in oxygenation and blood flow of breast and tumor for a larger cohort of breast~     radiotherapy patients. The current study has the following objectives:~        1. To determine the feasibility of BOLD contrast MRI of the breast, induced by breath-hold.~        2. To measure the change in BOLD contrast of the breast and / or chest wall tissue for~          females undergoing radiotherapy~   "
127499|NCT01898520|"~     A study to assess the effects of Sativex treatment on spasticity in a population of children~     and adolescents aged from 8 to 18 years with cerebral palsy or traumatic central nervous~     system injury. Efficacy (ability to improve symptoms), safety and tolerability will be~     monitored.~   "
127500|NCT01898507|"~     This study examines the effects of smoking low nicotine cigarettes in different groups of~     smokers. The investigators are focusing on differences in how smokers' bodies break down and~     eliminate nicotine from their systems. Some people are fast metabolizers of nicotine, meaning~     they break down and eliminate nicotine from their bodies more quickly. Other people are~     slower metabolizers meaning they break down and eliminate nicotine more slowly. The~     investigators are comparing these two groups of smokers for their responses to low nicotine~     cigarettes. The investigators hypothesize that individuals who smoke low nicotine cigarettes~     may smoke more intensely or smoke more each day, thereby maintaining their desired nicotine~     levels, and as a result continue to be exposed to significant toxin levels.~   "
127501|NCT01898494|"~     This randomized phase II trial studies how well transoral surgery followed by low-dose or~     standard-dose radiation therapy works in treating patients with human papilloma virus (HPV)~     positive stage III-IVA oropharyngeal cancer. Radiation therapy uses high-energy x-rays to~     kill tumor cells. Drugs used in chemotherapy work in different ways to stop the growth of~     tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation~     therapy with chemotherapy may kill any tumor cells that remain after surgery. It is not yet~     known how much extra treatment needs to be given after surgery.~   "
127502|NCT01898481|"~     The purpose of this pilot study is to test the feasibility of identifying and interviewing~     healthcare triads (patients, loved ones and oncologists) in a research study and evaluate the~     influences of patients' loved ones and oncologists on cancer treatment decision-making. the~     study team plans to explore concordance or discordance within the triad about the decisions,~     and also assess decisional conflict, regret and distress. Study methods involve interviewing~     a total of 75 patients, their loved ones and oncologists about past cancer treatment~     decisions. Analysis will consist mainly of qualitative content analysis. The investigators do~     not anticipate risk or safety issues beyond loss of confidentiality or minimal discomfort~     while discussing a cancer treatment decision.~   "
127503|NCT01898468|"~     Post-thoracotomy Pain Syndrome (PTPS) is defined as pain that recurs or persists along a~     thoracotomy scar at least 2 months following surgery. PTPS presents a frustrating challenge~     to patients and healthcare providers alike. PTPS can affect up to 80% of patients undergoing~     thoracotomies, and results in significant impairment. A proposed mechanism for PTPS is the~     compression of the intercostal nerves during routine closure. Closure of thoracotomies using~     intracostal sutures is a novel technique where sutures are passed through holes drilled into~     the rib; thus, avoiding compression of the nerves. We propose a double-blind, randomized~     control study involving 90 patients undergoing elective posterolateral thoracotomies.~     Participants will be randomly assigned to undergo thoracotomy closure with pericostal sutures~     or intracostal sutures. Our primary outcome will assess the incidence and severity of PTPS at~     3, 6, and 12 months after surgery between groups.~   "
127504|NCT01898455|"~     This study will be looking at the clinical efficacy of using a intranasal evaporative cooling~     device in providing relief of the symptoms of migraine and cluster headache. It will involve~     using a nasal catheter to spray a liquid coolant into the nasal cavity where it evaporates~     and removes heat from the tissue, thereby cooling the tissue and the blood vessels which~     supply blood to the brain. This cooling effect will cause the blood vessels to constrict and~     it is thought that this may provide symptomatic relief in both these forms of headache. 10~     migraine patients and 5 cluster headache patients will be enrolled in the study and will~     receive 10 treatments each, for a maximum of 20 minutes at a time. They will be monitored~     during the treatment and for two hours afterwards to assess headache severity and side~     effects. There will be a further follow up 2 months after the last treatment to assess for~     longer term side effects from the treatment.~   "
127505|NCT01898442|"~     Ticagrelor is a reversible direct acting P2Y12 antagonist, which has shown to be superior to~     clopidogrel, in adjunct to aspirin, in preventing recurrent ischemic events. Ticagrelor is~     considered a first line therapy to be administered as soon as possible in ACS patients.~     However, the pharmacodynamic effects of ticagrelor at the recommended 180mg loading dose are~     delayed in patients with STEMI undergoing primary PCI. The use of higher loading dose~     regimens of ticagrelor has therefore been advocated. The proposed investigation will have a~     prospective, randomized, parallel design in which STEMI patients undergoing primary PCI will~     be randomized to receive three different loading dose of ticagrelor (180 mg, 270 mg and 360~     mg). Pharmacodynamic testing will be performed at several time points to test our study~     hypothesis that a higher loading dose regiment will achieve more promptly enhanced platelet~     inhibitory effects.~   "
127506|NCT01898429|"~     In this pilot study, we propose to test whether high frequency stimulation of the subcallosal~     cingulate (SCC) is a safe and efficacious antidepressant treatment in five TRD patients, to~     compare the effects of left-sided vs. right-sided stimulation, and to investigate potential~     mechanisms of action of this intervention. Importantly, this study will be used to assess the~     need for and assist in planning a larger, more definitive trial of SCC DBS for TRD.~   "
127507|NCT01898416|"~     The purpose of this study is to evaluate the efficacy of preoperative 5-ALA oral~     administration and subsequently intraoperative tumor bed phototherapy with red light laser,~     as an adjuvant therapy on the 3 years rate of local tumor recurrence in patients with desmoid~     tumors. To evaluate the Safety of 5-ALA administration. 5 years local recurrence rate.~   "
127508|NCT01898403|"~     This clinical trial compares and contrasts lymph node mapping using indocyanine green~     (IC-GREEN), isosulfan blue (ISB), and TSC and Lymphoscintigraphy with 99-technetium (99Tc)~     sulfur colloid (TSC).~      Study participants with malignant melanoma will undergo all 3 evaluations to assess the~     extent of the spread of the melanoma.~   "
127509|NCT01898390|"~     The Transeuro Transplant study is a trial which will involve grafting foetal tissue into the~     brain of patients with Parkinson's disease, who are already been followed in the~     observational study. The tissue inserted in the brain is to help replace and rebuild lost~     dopamine from the brain due to Parkinson's disease. Only 20 patients will be selected for the~     transplant.~   "
127510|NCT01898377|"~     In this study we will combine mycophenolate mofetil and imatinib mesylate to treat~     steroid-refractory sclerotic/fibrotic type chronic graft-versus-host disease (GVHD) to see~     the response rate and to find the safety of combination.~   "
127512|NCT01898351|"~     Summary~      This research will examine the nutritional effects of supplementing diets with alternative~     plant sources of protein with potential to be grown in Scotland. In particular, we will~     assess the potential of these plant protein sources to complement diets in which the~     predominant source of protein is meat. These protein sources will include plants from the~     Fabaceae, Cannabaceae and Polygonaceae families, which could be used as the basis for the~     development of new foods. The research will assess if these plant proteins can deliver a~     comparable alternative to meat based diets.~      It is anticipated that the results could encourage increased consumption of plant products~     which would be favorable for consumers shifting away from animal-derived proteins for health~     and/or environmental reasons.~      Hypothesis: Consumption of protein rich plants could be a sustainable and healthy choice for~     partial replacement in predominantly meat based diets.~      Objective: The objective of this acute study is to assess satiety, postprandial effects,~     metabolite bioavailability and metabolism of single alternative proteins from a shortlist~     including buckwheat, fava beans, lupin, pea, and hemp in comparison with red meat.~      Study protocol~      Aims: To assess the impact of a pea, fava bean, lupin, hemp, buckwheat in comparison with~     meat in healthy people on:~        -  Biomarkers of satiety as measured by gut-related hormones and subjective appetite using~          visual analogue scales, specifically to be collected during the meal over a three hour~          period, every 30 minutes. The energy intake measured for each volunteer after an ad~          libitum lunch (five hours after test meal).~        -  Biomarkers of CVD risk including total cholesterol, low density lipoproteins (LDL), high~          density lipoproteins (HDL), triglycerides and non-esterified fatty acids (NEFA).~        -  Assessment of peripheral glycaemic control, fasting glucose, area under the curve~          combined with insulin data.~        -  Plasma and urine markers of important phytochemical and protein metabolites will be~          quantitatively analysed to determine the systemic availability, in vivo concentrations~          and excretion times.~        -  Volunteer views towards diets rich in plant proteins will be assessed.~   "
127513|NCT01898338|"~     To demonstrate that the combination of daptomycin and fosfomycin is superior to daptomycin~     alone in the treatment of methicillin resistant Staphylococcus aureus (MRSA) bacteremia.~   "
127514|NCT01898325|"~     The investigated cohort will examine liver and spleen fibrosis in patients with Gaucher~     disease divided into two groups, naive GD patients and GD patients treated with ERT. As liver~     biopsy in these patients not recommended because the risk of bleeding using Fibroscan is a~     safe with diagnostic accuracy regarding the liver (& Spleen) fibrosis. Estimating spleen~     fibrosis is an innovative approach in liver disease and Gaucher.~      The evaluation of fibrosis with this new and safe method could avoid complications~     antiinvasive procedure in GD patients. The addition of fibrosis biomarkers will help for~     patients score evaluation. The finding of liver and spleen stiffness will be evaluated in~     native and ERT treated Gaucher patients in order to assess ERT effect on fibrosis.~      The Aims are: 1) To assess liver and spleen stiffness measurement using fibroscan and~     evaluate liver and spleen fibrosis in patients with GD.~      2) To compare the elastography in two cohorts of GD patients: ERT treated and naïve GD~     patients and two control groups of patients: healthy and Non Alcoholic Steatohepatitis (NASH)~     patients.~      3) To correlate the elastography findings with clinical and laboratory data in the four~     patient groups focusing on Gaucher disease manifestations and GD severity. To compare the~     elastography in GD naïve and ERT treated patients.~   "
127515|NCT01898312|"~     Ovarian steroids, as well as their synthetic counterparts gestagens and estrogens have a role~     in breast cell proliferation and the development of breast cancer. Here, the effect of a~     progesterone receptor modulator, mifepristone, on cell proliferation in human breast tissue~     in vivo will be studied in women with BRCA-1 or -2 mutations. Our preliminary results~     implicate a possible protective effect of mifepristone in breast epithelium. The ability of~     mifepristone to block breast epithelial cell proliferation may prevent tumorigenesis and may~     also prove beneficial when used for contraceptive purposes and on other indications. The~     proposed project concerns a Randomized Controlled Trial on mifepristone versus placebo~     treatment of women with BRCA-1or -2 mutations with a high risk/incidence of breast cancer and~     ovarian cancer.~   "
127516|NCT01898299|"~     The purpose of the present research is to test a potential new treatment for auditory verbal~     hallucinations in schizophrenia that uses transcranial Direct Current Stimulation (tDCS), a~     neurostimulation technique that passes an extremely weak electric current through the brain.~     During the treatment, two electrodes are positioned on the scalp above regions of the brain~     implicated in abnormal cortical activity associated with auditory verbal hallucinations in~     schizophrenia. Due to the directional flow of current, one electrode, termed~     cathodal,inhibits cortical activity, and the other, termed anodal, increases cortical~     activity. These electrodes will be placed such that cathodal stimulation is applied to an~     area associated with hyperactivity and anodal stimulation to an area associated with~     hypoactivity. One preliminary study has revealed that this form of neurostimulation can~     alleviate auditory verbal hallucination symptoms both immediately following five days of~     treatment and up to three months after the final treatment. The goal of this study is to~     replicate these effects and explore the mechanisms that may underpin them.~   "
127517|NCT01898286|"~     This is an extension study to evaluate the safety and tolerability of long-term treatment~     with DiaPep277® and to determine the long-term treatment effect of DiaPep277® on parameters~     of metabolic control and on preservation of beta-cell function in subjects who have long~     exposure to DiaPep277®.~   "
127518|NCT01898273|"~     The primary objective of this trial is to determine the optimal dose and imaging time~     point(s) of I-124-CLR1404 in subjects with newly diagnosed and recurrent glioma to be used in~     future trials.~   "
127519|NCT01898260|"~     The purpose of this study is to compare the subjective performance of two daily disposable~     contact lenses with respect to comfort and handling.~   "
127520|NCT01898247|"~     The goal of the proposed research is to investigate the use a medical simulation and mastery~     learning (where all learners must reach a high standard before completion of training)~     curriculum to improve internal medicine residents' skills when performing thoracentesis~     procedures (remove fluid from around the lung) on patients. Additionally, we will evaluate~     how these skills affect patient outcomes by comparing thoracenteses performed by~     simulator-trained residents to those who have traditional training. This project will~     evaluate these overall hypotheses: simulation-based training using the mastery learning~     approach improves medicine resident's thoracentesis skills and improves patient outcomes and~     satisfaction.~   "
127530|NCT01898117|"~     Triple negative breast cancer (TNBC) is a difficult to treat molecular subtype with a poor~     survival. TNBC can be divided into at least two molecular entities; BRCA-like and~     non-BRCA-like. In this trial we would like to investigate whether a molecular subgroup exists~     within TNBCs that derives a benefit from atezolizumab added to first line chemotherapy.~   "
127671|NCT01896258|"~     As a first step towards reform of the emergency medical service system by standardizing~     triage scale to Korean Triage and Acuity Scale(KTAS), we aimed to assess the present status~     of our emergency department triage systems and illustrated the present status and problems of~     the Korean emergency department triage system.~   "
127521|NCT01898234|"~     Background:~      High- and low-flux dialysis membranes made of different materials may correlate with various~     hemodynamic tolerance profiles. This study aims to investigate hemodynamic response and~     incidence of hypotensive episodes by comparing some of the most commonly used high- and~     low-flux dialyzers.~      Methodology:~      The study was designed as an open label, randomized, cross-over investigation, including 25~     patients undergoing chronic hemodialysis. Four polysulfone dialyzers of 1.8 m2, A (Revaclear,~     Gambro), B (Helixone high flux, Fresenius), C (Xevonta, BBraun) and D (Helixone low flux,~     Fresenius), were compared with each other. The hemodynamic profile was assessed with a~     non-invasive technique and patients were asked to provide tolerance feedback through a~     questionnaire.~   "
127522|NCT01898221|"~     The broad, long-term objective of this project is to evaluate the therapeutic value of vein~     of Marshall (VOM) ethanol infusion when added to catheter ablation of atrial fibrillation~     (AF). AF is the most common sustained arrhythmia in adults, and it is a leading cause of~     stroke, disability and increased mortality. Catheter ablation - pulmonary vein (PV) antral~     isolation (PVAI)- can lead to cure, but is best suited for paroxysmal AF, in which ectopic~     beats arising from the pulmonary veins were shown to initiate AF. PVAI success is lower in~     persistent AF, in which the role of the cardiac autonomic system, particularly the intrinsic~     cardiac ganglia, is being increasingly recognized. Expanding the ablation lesions to include~     greater areas the left atrial (LA) anatomy marginally improves outcomes, but also leads to~     increases in procedural complexity and duration, need of repeat procedures, and complications~     such as atrial flutters, particularly perimitral flutter (PMF). The investigators have~     developed a technique to perform rapid ablation of atrial tissues in AF using ethanol~     infusion in the vein of Marshall (VOM), and have shown: 1) Effective, rapid and safe tissue~     ablation of LA tissue neighboring the LA ridge and left inferior PV; 2) Regional LA vagal~     denervation by reaching the intrinsic cardiac ganglia; and 3) Facilitation of cure of PMF by~     ablating most of the mitral isthmus.~      The investigators propose to evaluate outcomes differences yielded by VOM ethanol when added~     to conventional PVAI. The specific aims are: #1.To assesses the impact of VOM ethanol~     infusion in procedure success when added to de novo catheter ablation of persistent AF. The~     investigators will randomize patients with persistent AF undergoing a first AF ablation to~     standard PVAI vs. a combined VOM ethanol infusion plus PVAI (VOM-PV) #2. To assess the impact~     of VOM ethanol infusion added to repeat catheter ablation of recurrent AF after a failed~     ablation. Patients undergoing a repeat procedure for persistent AF after a failed PVAI will~     be randomized to either PVAI or VOM-PV as their repeat procedure. End points will include~     freedom from symptomatic or electrocardiographic AF after 12-15 months.~   "
127523|NCT01898208|"~     Would rapid identification of bacteria and rapid detection of methicillin-resistant S. aureus~     (MRSA) and vancomycin-resistant enterococci (VRE) (using an FDA-cleared assay) in positive~     blood culture bottles improve patient care at Mayo Clinic Rochester (or just lead to~     increased cost)?~   "
127524|NCT01898195|"~     Smoking rates among individuals living with HIV/AIDS range between 47% and 65%, a prevalence~     that is roughly three times the rate of the general population. This elevated prevalence is~     alarming given the increased likelihood of numerous adverse health outcomes experienced by~     HIV-positive smokers. Cigarette smoking is associated with greater levels of HIV-related~     symptom burden and appears to decrease the effectiveness of HAART as assessed by both viral~     load and CD4 counts (Vidrine 2009, Marshall 2009, Vidrine 2007, Miguez-Burbane 2005). PLWHA~     who smoke are also at increased risk of infections and noninfectious pulmonary complications~     and both AIDS-associated and non-AIDS-associated malignancies compared to nonsmokers. This~     study will refine and pilot test a theory-driven smoking cessation intervention that enhances~     existing behavioral approaches by testing the impact of text message reminders to take~     varenicline and the feasibility and additional impact of including adherence-focused~     behavioral cessation counseling. The investigators propose to randomize 190 participants,~     recruited from three HIV/AIDS clinic, to a three arm pilot study that compares: 1) Standard~     Care (SC), 2) SC + text message reminders, and 3) SC + text message reminders + cell~     phone-delivered adherence-focused behavioral therapy (ABT). Participants in all three arms~     will receive varenicline for 12 weeks. The primary outcomes are adherence to varenicline and~     biochemically validated smoking abstinence at 12 weeks and 3-month follow-up from the time of~     study enrollment.~   "
127525|NCT01898182|"~     The purpose of the study is to evaluate the change in the severity and clinical signs of skin~     photoaging among Filipino patients using Kinerase cream (Kinetin 0.1%). This study will~     recruit 132 subjects from dermatological clinics in a tertiary hospital in the Philippines~     for a period of 3 months (12 weeks). Changes in severity will be documented using physician~     evaluation, self-evaluation, and through VISIA complexion analysis system.~   "
127526|NCT01898169|"~     Electronic Nicotine Delivery Systems (ENDS), commonly referred to as electronic cigarettes~     have gained in popularity over the last several years. The technology used to manufacture~     ENDS has been evolving rapidly with a variety of delivery mechanisms, nicotine content,~     e-liquids and flavorings. Only in the last few years have researchers begun to examine the~     health risks and benefits, nicotine blood levels, patterns of use, likability, and craving~     and withdrawal relief of ENDS. These studies have shown great variability in nicotine~     delivery, effects on heart rate, and relief of craving or withdrawal among various ENDS~     brands among tobacco cigarette smokers.~      This study will test a new generation ENDS, the NJOY King Bold (NJOY, Scottsdale, AZ). It is~     a single use unit that resembles a traditional cigarette and delivers approximately 150~     puffs. The cartridge inside contains 26 milligrams of nicotine.~      Our primary objective is to evaluate the short-term effects of using the NJOY Kings ENDS on~     heart rate, carbon monoxide and blood nicotine levels and well as on craving for cigarettes~     and nicotine withdrawal. Our secondary objective is to evaluate the subject's usage patterns~     for cigarettes and NJOY King ENDS during a one-week period in which they can use each freely.~      The study includes three visits to the clinic spaced approximately one week apart. Subjects~     who pass the screening visit will return to the clinic for Visit 2 in which they will sample~     the NJOY King ENDS for about 20 minutes before taking home enough to last till Visit 3, one~     week later. They will be instructed to use as many or as few as they like during the week.~     Subjects will keep a daily diary of number of tobacco cigarettes smoked and number of~     e-cigarette puffs taken. Subjects will return to the clinic for Visit 3 after 12 hours of~     abstinence from any form of nicotine in order to assure that they have no nicotine left in~     their bloodstream. Eligible subjects will then participate in two series of 10 puffs of NJOY~     Kings spaced one hour apart. During the 2.5 hours of the testing day, the following will be~     measured: 1) heart rate, 2) carbon monoxide, 3)blood will be sampled for nicotine levels, 4)~     craving for cigarettes and nicotine withdrawal symptoms will be assessed.~   "
127527|NCT01898156|"~     This Phase 1/2 study is designed to assess the following: safety and tolerability of~     BIW-8962, Dose Limiting Toxicities (DLTs), Maximum Tolerated Dose (MTD), Recommended Phase 2~     Dose (RP2D) in Phase 1 in subjects with advanced/recurrent lung cancers or mesothelioma and~     preliminary efficacy in Phase 2 in subjects with advanced/recurrent Small Cell Lung Cancer.~   "
127528|NCT01898143|"~     Whole body vibration training seems to be a useful adjunct in exercise training in patients~     with severe COPD. The basic principle relies on reflectory muscle contractions caused by a~     vibration stimulus. Until now the impact of whole body vibration training on cardiopulmonary~     parameters remained unknown. Therefore aim of this study is to investigate cardiopulmonary~     parameters during whole body vibration training in patients with chronic lung disease.~   "
127576|NCT01897519|"~     This study will evaluate the safety and efficacy of ABT-719 in patients undergoing high risk~     major surgery.~   "
127577|NCT01897506|"~     Our central hypothesis is that dietary limitations introduced by food allergy will contribute~     to increased food insecurity in households with food allergic children when compared to food~     insecure households without food allergic children.~   "
127531|NCT01898104|"~     The purpose of this study is to first determine the maximum tolerated dose of capecitabine~     given alone or in combination with valproic acid during preoperative short-course~     radiotherapy (Phase 1). The next part of the study (Phase 2)will explore whether the addition~     of valproic acid or the addition of capecitabine to short-course radiotherapy, before optimal~     radical surgery might increase the pathologic complete tumor regression rate in patients with~     low-moderate risk rectal cancer.~   "
127532|NCT01898091|"~     This study involves adults receiving radiation therapy for head and neck cancer and will test~     whether or not the study mouthrinse may lessen oral mucositis.~   "
127533|NCT01898078|"~     This is an open-label, multicenter, phase 1 study with the primary objective of evaluating~     the effect of food on the single-dose PK properties of alisertib administered as the ECT~     formulation. The secondary objective is to further evaluate the safety and tolerability of~     alisertib.~   "
127534|NCT01898065|"~     With functional imaging development, it becomes possible to increase radiation dose to~     radioresistant areas (located inside tumor volume) using radiotherapy dose-painting. This~     strategy is particularly suitable for prostate cancer where tumor hypoxia plays a major role~     in the resistance of these tumors to radiation.~      In order to develop intratumoral hypoxia targeting by radiotherapy dose-painting areas, we~     should characterize changes in hypoxia before treatment and during radiotherapy.~        -  If hypoxia does not change during radiotherapy, radiotherapy dose-painting strategy by~          an integrated boost is performed.~        -  If hypoxia varied (increasing or incomplete regression), a final boost strategy of~          radiotherapy dose-painting(IMRT, stereotactic brachytherapy or high dose rate) after a~          first fractionated IMRT could be considered.~      This study should show that PET imaging with fluoromisonidazole (18F-MISO) is an available~     tool to physicians in assessing tumor hypoxia.~   "
127535|NCT01898052|"~     The purpose of this study is to determine the periarticular multimodal drug injection has~     more efficacy for controlling pain after TKA than single anaesthetic drug injection.~   "
127536|NCT01898039|"~     This study is designed for patients who had malignant melanoma and, following tumor removal,~     are now free of disease, or have only very minor residual disease, and are at a very high~     risk of disease recurrence. These patients will be treated with the A2/4-1BBL melanoma~     vaccine, a compatible melanoma cell line that has been engineered to express a molecule~     termed 4-1BBL, which enhances the chances of the cell line to be recognized by the patient's~     immune system, and to induce its stimulation. The hypothesis that drives the study states~     that the immune response against the cell line will also be effective against the residual~     tumor that may still be present in the body.~   "
127537|NCT01898026|"~     The proposed study will examine the effects of incorporating a soluble fibre blend into~     commonly consumed refined carbohydrate foods on sensory parameters and postprandial blood~     glucose. A sensory evaluation will be conducted in phase I to asses for differences between~     the control and fibre enriched samples of white bread, mashed potatoes, muffin, hot breakfast~     cereal. Phase II will be investigating the postprandial blood glucose responses of the 8 test~     foods from phase I.~   "
127538|NCT01898013|"~     The study design is a randomized, double-blind, two-arm trial of pregnenolone and placebo to~     determine the possible analgesic effects in OEF/OIF Veterans with chronic low back pain. The~     total study duration is 6 weeks (followed by two-follow up phone calls). All patients will~     monitor pain symptoms for one week with pain diaries, followed by a 1-week placebo-only~     lead-in period, 90 subjects will be randomly assigned to one of two groups. Of these~     subjects, 45 subjects will receive pregnenolone, and 45 subjects will receive placebo for 4~     weeks. Patient interview assessments and laboratory studies will be performed at each~     interview time point. Pregnenolone, allopregnanolone and other neurosteroid metabolites will~     be determined by gas chromatography / mass spectrometry (GC/MS), proceeded by high~     performance liquid chromatography (HPLC).~   "
127539|NCT01898000|"~     The present study was a randomized control clinical trial, which included 90 subjects with~     chronic generalised gingivitis of age group 25-40 years, reporting to outpatient department~     of Periodontics, Government Dental College & Research Institute, Bangalore form January 2013~     to April 2013. The research protocol was initially submitted and approved by the~     Institutional Ethical Committee and Review Board of the Government Dental College and~     Research Institute, Bangalore. After ethical approval, all subjects were verbally informed~     and written signed informed consent was taken for participation in the study.~      Ninety subjects diagnosed with chronic generalized gingivitis were randomly assigned into~     three groups: Group I: Placebo mouthwash, Group II: Triphala (TRP) mouthwash, Group III:~     Chlorhexidine (CHX) mouthwash. Subjects were instructed to use mouth wash twice daily. The~     plaque index (PI), gingival index (GI) and oral hygiene index- simplified (OHI-S) and~     microbiological colony counts were recorded on baseline (B/L) and 7, 30 and 60 days~     respectively.~      TRP mouthwash was found to decrease the inflammatory parameters. As improvement in gingivitis~     was comparable to that of CHX mouthwash thus TRP mouthwash can be considered as a potential~     therapeutic agent in treatment of gingivitis.~   "
127540|NCT01897987|"~     This is a follow-up study to investigate the long-term safety and efficacy of PNEUMOSTEM®~     versus placebo, for the treatment of BPD in premature infants. Subjects who participated in~     and completed the initial stage of the Phase II trial (NCT01297205 ) will be followed-up~     until 60 months of corrected age.~   "
127541|NCT01897974|"~     Children with seizure disorder face unique challenges during the perioperative period.~     Fasting, sleep-deprivation, and missed doses of medications while patients are required to~     have nothing per mouth (NPO) are a few factors that decrease the seizure threshold. The~     incidence of seizures in this population is unknown but correlated with patient's underlying~     condition and missed doses of anti-convulsant. Previous work has determined this is not a~     unique problem.~      The investigators initially found compliance extremely poor at 60%. The investigators have~     made improvement to about 80% compliance through various interventions: education of nursing,~     availability of anticonvulsant intravenous dosing alternatives, and re-wording the hospital~     NPO policy. The investigators feel that a new, more focused, survey will help identify,~     perioperative reasons for non-compliance on part of the parents. This information will be~     utilized to guide further interventions aimed at improving compliance.~   "
139454|NCT01741987|"~     The purpose of this project is to determine the effectiveness of an eyewash osmoprotective~     lubricant comparing to castor oil containing and non-osmoprotective lubricants in different~     types of DTS and post refractive surgery patients.~   "
127542|NCT01897961|"~     The Membranous nephropathy (GEM)idiopatic is the most frequent cause of syndrome néphrotique~     at the adult and represent approximately 2 % of the causes of terminal chronic renal~     insufficiency. A etiology balance assessment must be systematically realized to eliminate a~     secondary cause. Antibodies managed against the receiver of phospholipases A2 secreted by~     type M (PLA2R1) was recently detected in a population of GEM idiopatic, but not secondary~     GEM. PLA2R1 is expressed by the podocytes of the glomerules of healthy subjects, and this~     receiver co-is located with the deposits of extramembraneous IgG of the expanding subjects of~     idiopathique GEM. The good IgG the extramembraneous depositsof GEM idiopathic recognize~     PLA2R1. At some patients, the activity anti-PLA2R1 seems to decrease or to disappear during~     the stake in forgiveness of the disease.~      Some cases of second offense of GEM idiopathique after renal transplantation presenting~     antibodies anti-PLA2R1 have also described. The appearance of antibody anti-PLA2R1 seems~     parallel to the increase of a proteinurie in touch with a second offense of GEM, and~     antibodies sometimes disappeared after a therapeutic strengthening by Rituximab allowing to~     obtain a forgiveness.~      A GEM can also appear of novo on the renal transplant, it is to say without notion of GEM on~     the native loins. The physiopathology of this affection remains unknown.~      Working hypothesis and objectives We shall look in which proportion the presence of antibody~     anti-PLA2R1 is associated with the second offense of GEM idiopathic in renal transplantation.~     We anticipate that the GEM of novo of the renal transplant answers a different~     physiopathology, and will not be associated with the presence of antibody anti-PLA2R1. We~     hope to demonstrate that at the expanding patients of antibody anti-PLA2R1, the title of~     these antibodies is correlated in the activity of the disease and in the renal survival, and~     that the longitudinal follow-up of the title of these antibodies has an interest forecast and~     therapeutics.~   "
127543|NCT01897948|"~     This clinical trial will measure Docosahexaenic Acid (DHA) levels in the blood and evaluate~     the relation to cognitive outcomes.~   "
127544|NCT01897935|"~     This is a cross sectional study of a novel non-invasive optical flare photometer (OFAM).~     Patients meeting the inclusion/exclusion criteria will receive a standard eye examination~     including a slit lamp examination to collect ocular flare data. In addition to the standard~     eye examination, subjects will receive flare measurements using the OFAM device.~   "
127545|NCT01897922|"~     This clinical trial will evaluate an investigational infant formula with a probiotic to~     determine if it provides normal growth and if it is well tolerated by term infants compared~     to a marketed routine infant formula.~   "
127546|NCT01897909|"~     The main objective of the study is to investigate the impact of H. pylori infection on immune~     activation and clinical outcome in HIV patients.~      Other specific study objectives are:~        1. To investigate the effects of H. pylori infection on immune activation and the T-cell~          profile in HIV positive patients and compare those with HIV negative controls.~        2. To assess the influence of H. pylori infection on virological and immune parameters, and~          on clinical progression of HIV infection (WHO stage, opportunistic infections).~        3. To assess the prevalence of H. pylori infection among HIV patients in the Komfo Anokye~          Teaching Hospital.~        4. To assess the prevalence of gastrointestinal symptoms in HIV patients in Kumasi.~        5. To assess the association of H. pylori infection with gastrointestinal symptoms and~          pathology in HIV patients.~        6. To compare the clinical and immunological response to antiretroviral therapy and in~          HIV-patients with and without concomitant H. pylori infection.~   "
127547|NCT01897896|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of~     SD-809 ER in subjects switching from tetrabenazine to SD-809 ER. In addition, the safety and~     tolerability of long term treatment with SD-809 ER will be assessed in Switch subjects as~     well as Rollover subjects completing a randomized, double blind, placebo controlled study~     of SD-809 ER,~   "
127548|NCT01897883|"~     The purpose of this study is to provide current and reliable data of dyslipidimia management~     together with control situation of blood pressure and glucose for post-stroke patients within~     6-12 months from attack, and also the association between patient characteristics and control~     rate of lipids in this population.~      It is an non-interventional study, no study specified treatment is required.Approximately~     5000 post ischemic stroke patients within 6-12 months from attack will enter into the study.~     Fifty centres from different regions of China will participate in this study.~   "
127549|NCT01897870|"~     the purpose of this study is to determine the the effect of a home-based medication~     management program on drug-related problems post-discharge.~   "
127550|NCT01897857|"~     In atherosclerotic patients undergoing kidney transplantation, arterial cannulation is~     commonly performed for continuous monitoring of systemic blood pressure and intermittent~     assessment of arterial blood gases. The radial artery is the preferred artery, because of its~     well-documented low complication rate and easy access, but, radial artery cannulation is may~     associated with complications. Atherosclerosis is a systemic phenomenon, and structural~     changes attributable to atherosclerosis, such as luminal narrowing, intimal hyperplasia, and~     reduction in distensibility occur frequently throughout the arterial tree. Especially in~     patients with diabetes mellitus (DM), the radial artery is prone to atherosclerosis and~     perhaps calcification. In a recent study, it was found that the radial artery flow was~     decreased immediately after cannulation, but recovered to its pre-cannulation value after~     5min, whereas a compensatory increase of blood flow in the ulnar artery occured immediately~     after cannulation, persisting until 5 min. This study enrolled the patients of ASA physical~     status 1-2. In the patients scheduled for elective kidney transplantation, this compensatory~     increase of blood flow in the ulnar artery may not be occurred, because of atherosclerosis,~     particularly in patients with DM. In our study, we found whether there is appropriate~     compensatory increase of blood flow in the ulnar artery after the radial artery cannulation~     in two groups, patients with DM (group DM) or without DM (group nonDM), both undergoing~     elective kidney transplantation.~   "
127551|NCT01897844|"~     The purpose of this study is to assess the safety,tolerability, pharmacokinetics (PK) and~     pharmacodynamics (PD) of an extended dosing regimen of ITF2984: part A, designed as~     double-blind, placebo-controlled, randomized, tested an extended dosing regimen, i.e. 14~     consecutive dosing days and higher doses, i.e. up to 6000 mcg/day and in part B, open label,~     continuous subcutaneous infusion for 7 days were tested as ascending doses of ITF2984 up to~     9000 mcg/day of ITF2984.~   "
127552|NCT01897831|"~     In the proposed study, the investigators plan to evaluate the efficacy and safety of~     Piperacillin sodium and sulbactam sodium for injection (2:1) for the treatment of respiratory~     and urinary tract acute bacterial infection under the widely used in clinical conditions.~   "
127553|NCT01897818|"~     ALS is a severe progressive neurodegenerative disease characterized by degeneration motor~     neurons leading to death in 3 to 5 years. Gradually in time, the patient deprived of all~     motor skills as well as the possibility of communication written and oral developing a state~     close Locked In Syndrome (LIS). The main objective is to establish the feasibility of~     brain-computer interface using the pathological condition, with dependent disabled subjects~     as a means of communication.~   "
127554|NCT01897805|"~     Title:~      A randomized, double-blind, multi-centered, placebo-controlled trial to examine effects of of~     Heart-protecting Musk Pill on clinical outcomes in patients with chronic stable coronary~     artery disease~      Objective:~      To examine effects of of Heart-protecting Musk Pill, a traditional Chinese medicine, on~     clinical outcomes in patients with chronic stable coronary artery disease~      The study hypothesis:~      The null hypothesis: the combined incidence of cardiovascular death, nonfatal myocardial~     infarction, nonfatal stroke in the treatment group is the same as that in control group.~      The alternative hypothesis: the combined incidence of cardiovascular death, nonfatal~     myocardial infarction, nonfatal stroke in the treatment group is different from that in~     control group.~      Sample size:~      2700 patients will be randomized, 1350 in treatment group and 1350 in placebo group.~      Number of sites: 99 sites in China~      Study drugs:~      Heart-protecting Musk Pill and the matching placebo pills.~      Design:~      A randomized, double-blind, multi-centered, placebo-controlled trial. Patients will be~     randomized to treatment group and placebo group after screening and get corresponding~     treatment as follow.~      Treatment group: Standard treatment for coronary artery disease plus 2 Heart-protecting Musk~     Pills each time, three times a day by mouth for 24 months.~      Control group: Standard treatment for coronary artery disease plus 2 placebo pills each time,~     three times a day by mouth for 24 months.~      Patients will be followed up at baseline, 1, 3, 6, 9, 12, 18, 24 months after randomization.~     During follow-up period, patients could undertake PCI or CABG if angina get out of control or~     evidence of ischemia aggravated is found.~   "
127555|NCT01897792|"~     The purpose of this study is to determine the effect of antioxidant vitamins (vitamins C and~     E) on the development of coagulation derangements and nosocomial pneumonia after severe~     trauma in patients.~   "
127556|NCT01897779|"~     RPX7009 (beta-lactamase inhibitor) is being studied in combination with a carbapenem~     (RPX2014) to treat bacterial infections, including those due to multi-drug resistant~     bacteria.~   "
127557|NCT01897766|"~     The objective of this surveillance is to collect Safety and Effectiveness information for~     Long term Use of Somatropin for Patients with a Small for Gestational Age (SGA).~   "
127558|NCT01897753|"~     The purpose of this protocol is to retrospectively study the influence of age at start of~     growth hormone (GH) treatment on height gain in children born small for gestational age~     (SGA).~   "
127559|NCT01897740|"~     The purpose of this study is to provide Sildenafil therapy for subjects who completed~     A1481156 study and are judged by the investigator to derive clinical benefit from continued~     treatment with Sildenafil, prior to reimbursement and availability for subjects in the~     Russian Federation.~   "
127560|NCT01897727|"~     Hypertension affects an estimated 60-70 million Americans, predisposing them to potentially~     life threatening cardiovascular complications. Resistant hypertension, defined as~     uncontrolled blood pressure on 3 or more different antihypertensive agents, is common,~     affecting 15-20% of the entire hypertensive population or an estimated 12-14 million~     Americans. Although associated with obesity, increasing age, black race, and chronic kidney~     disease, mechanisms of treatment resistance remain obscure. The investigators' laboratory~     identified primary aldosteronism (PA) as a common cause of treatment resistance with a~     prevalence of 20% among subjects with resistant hypertension. This is clinically important~     because recognition of PA can lead to effective treatment with use of aldosterone blockers.~     Obstructive sleep apnea (OSA) is strongly associated with and predicts development of~     hypertension as demonstrated in landmark cohort studies including the Sleep Heart Health~     Study and the Wisconsin Sleep Cohort Study.~      The investigators' laboratory has confirmed OSA to be extremely common in subjects with~     resistant hypertension, with a prevalence of approximately 85%. Recognizing that PA and OSA~     are exceptionally common in subjects with resistant hypertension, the investigators~     hypothesized that the 2 may be causally related. In testing this hypothesis, the~     investigators recently reported that plasma aldosterone levels are positively correlated with~     OSA severity in subjects with resistant hypertension but not in normotensive control~     subjects. This observation suggests that there is an important mechanistic interaction~     between untreated OSA and aldosterone excess in subjects with resistant hypertension. While~     the investigators' original hypothesis was that OSA stimulates aldosterone release, the~     investigators recognize that the opposite may also be true; that is, aldosterone excess in~     subjects with resistant hypertension worsens OSA. Distinguishing between these two~     possibilities has potentially far-reaching clinical implications. If the former hypothesis is~     true, effective treatment of OSA would be expected to suppress aldosterone release in~     subjects with resistant hypertension, thereby reversing the underlying cause of their~     treatment resistance. If the latter hypothesis is true, use of mineralocorticoid receptor~     antagonists would be expected to reduce OSA severity in subjects with resistant hypertension,~     thereby enhancing treatment of OSA. Either scenario would represent a new treatment approach~     for a highly prevalent and serious medical problem.~   "
127561|NCT01897714|"~     The study will explore escalating doses of melflufen in combination with dexamethasone in~     small groups of patients to find the maximum tolerated dose of melflufen. That dose will then~     be used to determine the efficacy and safety profile of melflufen in combination with~     dexamethasone in a larger group of patients.~   "
127562|NCT01897701|"~     This is a randomized, observer-blinded, placebo-controlled trial in adults ≥18 years old.~     Randomization will be stratified by age (18 to 49 years and ≥50 years) and by prior influenza~     immunization within the past three months. Proportions of subjects in the various strata will~     not be pre-specified; rather, the goal will be to achieve an approximately equal distribution~     of subjects with these characteristics across the various treatment groups.~      Treatments will comprise two identical IM doses at a 21-day interval (Day 0 and Day 21), in~     alternate deltoids. For each subject, study follow-up will span approximately 385 days total,~     or approximately 13 months from the first dose.~   "
127563|NCT01897688|"~     Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells~     are destroyed, resulting in poor blood sugar control. The purpose of this study is to~     determine the safety and effectiveness of islet transplantation, combined with~     immunosuppressive medications, specifically using Campath as induction, for treating type 1~     diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic~     episodes.~   "
127564|NCT01897675|"~     Management of abscesses traditionally involves incision and drainage (I&D). Abscesses are~     frequently are packed or stented open with the presence of a wick, and traditional care~     requires re-visits every 2-3 days to have the packing removed and replaced, until finally the~     abscess cavity has closed, usually 1-2 weeks after initial presentation.~      Recently there have been attempts to employ less invasive techniques for abscess management.~     One novel technique, loop drainage, has been reported in case reports/case series for~     management of a variety of types of abscesses in the surgical subspecialty literature.~      We propose to conduct a randomized prospective study comparing the efficacy of the loop~     drainage technique with the traditional incision and drainage technique of abscess~     management.~      Patients presenting to the main or urgent care areas of the Emergency Department at Boston~     Medical Center for treatment of an abscess will be considered for enrollment as potential~     subjects. After the treating clinician identifies the patient as an appropriate subject, a~     Research Associate (RA) will approach the patient and obtain written informed consent to~     enroll in the study. The subject will then be randomized to the management arm of either loop~     drainage or traditional I&D. The clinician will fill out a data sheet describing the abscess~     characteristics, and then perform either loop drainage or incision and drainage, depending on~     randomization and the subject will fill out a satisfaction survey. Fourteen days after~     initial visit, subjects will return for follow-up. The subject will fill out a satisfaction~     survey, and a study investigator blinded to the treatment group will assess the subject for~     abscess resolution, cosmetic outcome, number of follow-up visits, and complications.~      The study investigators will then compare outcomes between the two study groups.~   "
127565|NCT01897662|"~     NUTRIOSE is a food ingredient defined as a carbohydrate polymer of vegetable origin (wheat~     starch or corn) with a degree of polymerization ≥ 3 and chemically transformed. It is soluble~     in aqueous solution, very poorly digested in the small intestine, it mostly reaches the colon~     where it stimulates fermentation. AFSSA, in its opinion of July 30, 2007, considers that this~     ingredient is a soluble dietary fiber. Recent work in China in overweight volunteers have~     shown an effect of NUTRIOSE on satiation and satiety, and demonstrate an effect on reducing~     weight and fat mass. By its action on satiety and reduced food intake, the NUTRIOSE be of~     interest in the management of overweight or obese. Among the possible mechanisms of action,~     are the metabolites produced by colonic fermentation of NUTRIOSE.~      The goal of this biomedical research is to study the effect of a dose of 14g/day of NUTRIOSE~     FB06 for 12 weeks on the evolution of weight, percentage of body fat and digestive tolerance~     in Caucasians overweight subjects. To gather evidence to support mechanisms of action, it is~     proposed to measure before consumption, then every 4 weeks, the effects of NUTRIOSE FB06 on~     satiety and satiation and changes in colonic flora and its metabolites.~   "
127566|NCT01897649|"~     NUTRIOSE is a food ingredient defined as a carbohydrate polymer of vegetable origin (wheat~     starch or corn) with a degree of polymerization ≥ 3 and chemically transformed. It is soluble~     in aqueous solution, very poorly digested in the small intestine, it mostly reaches the colon~     where it stimulates fermentation. AFSSA, in its opinion of July 30, 2007, considers that this~     ingredient is a soluble dietary fiber. The objective of this research is to determine,~     among healthy subjects, the effect of this dietary fiber on changes in gut microbiota and~     digestive tolerance during a 28 days consumption. Microbiological analyzes will be performed~     by RT-PCR. Digestive tolerance will be measured by the intelligence of a questionnaire by~     volunteers.~   "
127567|NCT01897636|"~     Pancreatic cancer is the second most frequent gastrointestinal malignancy. The overall~     survival is dismal. Especially for advanced pancreatic cancer, the conventional approaches~     are typically not curative and provide only minor increases in survivals in most cases.~     Dendritic cells (DCs) are powerful antigen-presenting cells (APCs) that play a pivotal role~     in the initiation, programming, and regulation of tumor-specific immune responses. Isolated~     DCs loaded with tumor antigen ex vivo and administered as a cellular vaccine have been found~     to induce protective and therapeutic anti-tumor immunity in experimental animals. Some~     clinical trials of DC vaccination for cancer patients have shown the induction of anti-tumor~     immune responses and tumor regression. Endoscopic ultrasound (EUS) is an established~     technique for the diagnosis and staging of pancreatic cancer. Endoscopic ultrasound guided~     fine-needle direct injection of dendritic cells vaccination into pancreatic tumors may be a~     promising treatment modality.Therefore, The purpose of the study is to evaluate the efficacy~     and safety of endoscopic ultrasound guided fine-needle injection of DCs vaccination into~     advanced pancreatic cancer~   "
127568|NCT01897623|"~     The purpose of this study is to investigate the prevalence of abdominal aortic aneurysms~     (AAA) among male patients with coronary artery disease (CAD) verified in coronary~     angiography. Ethiology of AAA is known to be common with atherosclerotic arterial diseases~     (coronary artery disease, peripheral artery disease and carotid artery disease), so the~     hypothesis is that AAA should be more common among these CAD patients, thus making screening~     of these patients (for AAA) more cost-efficient.~      Study will be carried out as a multi-center prospective screening study. Data will be~     collected in North Karelia Central Hospital, Kuopio University Hospital and Tampere~     University Hospital. Data consists of 200 consecutive coronary angiography patients in each~     hospital, resulting in 600 patients in total. All male patients with diagnosed CAD will be~     recruited for the study and screened for AAA with ultrasound. Nevertheless, patients with~     previously known AAA will be excluded from the study.~   "
127569|NCT01897610|"~     Immuncell-LC in aspects of therapeutic efficacy and safety when administered with Nexavar~     to advanced Hepatocellular carcinoma patients when compared with the control group who did~     not receive administration of the drug.~   "
127570|NCT01897597|"~     The purpose of this trial is to investigate the relative bioavailability of a BI 144807~     tablet formulation compared to the oral solution formulation after single dose administration~     (intermediate and high dose) under fasted conditions. Further objectives are to assess~     whether and to what extent food affects single dose pharmacokinetics of BI 144807~     administered as tablet, and to compare the relative bioavailability of two different tablet~     formulations.~   "
127571|NCT01897584|"~     Changes of inspiration: expiration ration from 1:2 to 1:1 could improve the arterial~     oxygenation and respiratory mechanics~   "
127572|NCT01897571|"~     This is a multicenter, open-label, Phase 1/2 study that is being conducted in two parts. The~     Phase 1 part (closed to accrual as of January 25, 2016) is comprised of dose escalation and~     expansion parts to establish the MTD and/or the recommended Phase 2 dose (RP2D) when~     tazemetostat is given BID (twice daily) orally on a continuous basis. Additionally, in~     separate cohorts in Phase 1, the effect of food on the bioavailability of tazemetostat as~     well as the drug-drug interaction (DDI) potential of tazemetostat are being evaluated. The~     Phase 2 part was initiated once the MTD and /or RP2D was established. Phase 2 enrolls~     subjects with DLBCL (Cohorts 1-3 and 6) and FL (Cohorts 4 and 5) for the determination of~     efficacy and safety of tazemetostat monotherapy (Cohorts 1-5) and of tazemetostat in~     combination with prednisolone (Cohort 6) with placement determined by centrally confirmed~     histology, cell of origin (COO), and EZH2 mutation status.~   "
127573|NCT01897558|"~     Pacemaker electrodes are either equipped with tines (passive fixation) or with a screw~     (active fixation) for initial fixation in the patient´s heart. Both types of electrodes~     provide similar results in a long-term follow-up and the use of one or the other electrode~     type in many instances is mainly based on the implanter´s preference. The PACMAN-trial~     investigates whether the two lead types are associated with different amounts of myocardial~     micro-damage during implantation.~   "
127574|NCT01897545|"~     The purpose of this study is the comparative evaluation of systolic blood pressure (SBP)~     lowering, atrial fibrillation (AF) recurrence and clinical data in patients with~     paroxysmal/persistent AF and resistant/non-resistant hypertension, undergoing AF ablation~     alone or combined with percutaneous renal denervation.~   "
127575|NCT01897532|"~     The aim of the study is to investigate the longterm impact on cardiovascular morbidity,~     mortality and renal function of treatment with linagliptin in a selected population of~     patients with T2DM and to compare outcomes against placebo, on a background of standard of~     care.~   "
127579|NCT01897480|"~     The primary purpose of this study is to compare the efficacy of the study drug LY2875358,~     given together with erlotinib, against erlotinib, alone. Participants will have Non-Small~     Cell Lung Cancer (NSCLC) that has advanced to Stage IV. Participants should not have been~     treated with drugs for Stage IV NSCLC, previously. All participants will get erlotinib alone,~     for approximately 8 weeks. Participants with radiographic disease control at the end of the~     erlotinib lead-in study period will be randomly assigned to receive LY2875358 plus erlotinib~     or erlotinib alone. Participants, who were chosen to receive erlotinib, alone, may cross over~     to the combination treatment at the time of progression.~   "
127580|NCT01897467|"~     Losses of muscular fitness/balance are common occurrences with aging that can lead to an~     increased fall-risk. The accelerated bone loss that may accompany menopause makes some women~     even more at-risk for serious consequences related to falling. Interventions to reduce~     fall-risk have been conducted in an attempt to improve balance or muscular fitness, but often~     these interventions require monotonous exercises that don't arouse enough long-term interest~     to elicit the improvements. In other words, while the intervention may be beneficial,~     participants quit before they can realize any gains.~      Currently, there is little research that uses novel technology-based programs to promote~     balance exercises among middle-aged women. The Wii Fit system includes various strength and~     balance exercises integrated into games intended to have the participant have fun and retain~     interest, while also improving fitness. By using such a program, women could potentially~     improve their balance and decrease their fall risk in a way that is fun and exciting.~      The purpose of this study is to investigate the effect of a Wii Fit based exercise program on~     balance/muscular fitness/markers of bone health in women between the ages of 45-60 with low~     bone mass. Volunteers who have moderately low bone levels (n = 28) will be randomly assigned~     to either the Wii Fit exercise intervention or a normally active control. Balance ability,~     muscular fitness, body composition, physical activity levels and markers of bone health will~     be assessed before and after the intervention.~      Each participant in the intervention will be provided a pre-programmed Wii Fit console and~     balance board to use at home. The intervention will consist of a 12-week program that they~     perform 30 minutes a day 3 days a week. The exercises include 10 minutes of Yoga poses and~     strength exercises and then 20 minutes of balance games such as soccer heading, ski slalom~     and table tilt.~      At the 6 week point and the conclusion of the intervention, participants will come to the lab~     for testing on the same tests done initially.~      The overall goal of this study is to gauge the efficacy of this intervention to improve~     balance, fitness, and bone health in at-risk women. This project is important because it~     offers an exciting, fun, and motivating way to impact fall-risk before clinical symptoms~     develop. Overall, this intervention could significantly reduce healthcare dollars spent on~     fall-related outcomes, as well as reduce fall-related mortality.~   "
127581|NCT01897454|"~     This phase II trial studies how well combination chemotherapy, gemcitabine hydrochloride, and~     radiation therapy before surgery works in treating patients with pancreatic cancer that has~     not spread to other places in the body and can be removed by surgery. Drugs used in~     chemotherapy, such as fluorouracil, leucovorin calcium, irinotecan hydrochloride,~     oxaliplatin, and gemcitabine hydrochloride, work in different ways to stop the growth of~     cancer cells, either by killing the cells or by stopping them from dividing. Fluorouracil,~     irinotecan hydrochloride, and gemcitabine hydrochloride may also stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy~     and gemcitabine hydrochloride with radiation therapy before surgery may make the tumor~     smaller and reduce the amount of normal tissue that needs to be removed.~   "
127582|NCT01897441|"~     This randomized pilot clinical trial studies chemotherapy before surgery and tissue sample~     collection in patients with stage IIA-IIIC breast cancer. Drugs used in chemotherapy, such as~     doxorubicin hydrochloride, cyclophosphamide, and paclitaxel, work in different ways to stop~     the growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Monoclonal antibodies, such as trastuzumab, may interfere with the ability of tumor cells o~     grow and spread. Giving doxorubicin hydrochloride, cyclophosphamide, paclitaxel and~     trastuzumab may kill more tumor cells. Collecting and storing samples of tissue from patients~     with breast cancer to study in the laboratory may help doctors learn more about how well~     patients will respond to treatment.~   "
127583|NCT01897428|"~     To compare the relative bioavailability and pharmacokinetic characteristics of a newly~     developed bepotastine formulation, bepotastine salicylate, with a conventional formulation,~     bepotastine besilate, in healthy subjects with a single dose, randomized, open-label,~     2-sequence -2period crossover study.~   "
127584|NCT01897415|"~     This is a Phase I safety and feasibility study. Subjects will be enrolled serially. For~     subject safety, the preceding subject must have completed one cycle of therapy (28 days)~     before the next subject can be treated. Subjects will be treated with i.v. administration of~     1 to 3e8 per meter squared RNA CAR T cells three times weekly (M-W-F) for three weeks.~   "
127585|NCT01897402|"~     The purpose of this study is to evaluate the production of antibodies to a new conjugate~     vaccine, NmVac4-A/C/Y/W-135-DT, as a measure of vaccine effectiveness, compared to the~     production of antibodies to a similar, licensed meningococcal (Groups A, C, Y, W-135)~     polysaccharide diphtheria toxoid (DT) conjugate vaccine. The investigators will also evaluate~     the safety of NmVac4-A/C/Y/W-135-DT™ conjugate vaccine compared to the licensed vaccine. The~     hypothesis is that the test vaccine is comparable to the licensed active control vaccine.~   "
127586|NCT01897389|"~     The purpose of this study is to evaluate the relative bioavailability of 4 new formulations~     of abiraterone acetate compared to the current commercial formulation.~   "
127587|NCT01897376|"~     The purpose of this study is to determine if there is a difference between Pfannenstiel and~     midline vertical skin incision at time of cesarean section in preventing wound complications~     in the morbidly obese patient. This is a comparative effectiveness study of two commonly-used~     skin incisions. The investigators plan to enroll morbidly obese obstetrical patients upon~     admission and randomize them to one of the above incision types in the operating room. The~     investigators will follow them for 6 weeks post-op to evaluate for wound complications. There~     is minimal risk to the participant as both incision types are acceptable in current~     obstetrical practice. There is no direct benefit to the patient.~      Currently, there is no level I evidence to support either Pfannenstiel or midline vertical~     skin incision in the prevention of wound complications in the obese patient undergoing~     cesarean section. Therefore, current practice is for the surgeon to make the decision based~     on preference and weighing theoretic risks. Therefore, there is clinical equipoise. Cesarean~     section is a very common procedure, with a national rate of 32% of all live births in 2007.~     Not only does obesity increase the expectant mother's risk of a cesarean section, it is also~     a well recognized risk factor for wound complication. The cesarean wound complication rate in~     the morbidly obese population at the University Of Texas at Houston - Memorial Hermann~     Hospital Texas Medical Center in 2011 was roughly twenty times as high as the normal weight~     population, 28% compared to 1.4%. Results from this study could be extrapolated in the future~     to affect lower post-operative morbidity, higher patient satisfaction, less antibiotic use,~     shorter hospital stay, and overall lower health care costs.~   "
127589|NCT01897350|"~     Cardiac magnetic resonance imaging (CMR) is a non invasive technique used to obtain~     functional and anatomical information on the heart. Several CMR parameters measured after~     primary percutaneous coronary intervention (PPCI) have been shown to have prognostic value~     and are increasingly being used as surrogate endpoints in clinical trials. Myocardial oedema~     is a prognostic indicator following myocardial infarction1. Myocardial salvage is calculated~     as the myocardial oedema minus infarct size; this again is a prognostic indicator following~     STEMI. However, myocardial oedema imaging is controversial. There are multiple sequences~     available, with no standardisation of sequences used to assess this surrogate endpoint. The~     investigators propose to conduct a study to measure the myocardial oedema by all available~     techniques to determine the agreement between these methods.~   "
127590|NCT01897337|"~     PONV (Postoperative nausea and vomiting) is one of most common complications after general~     anesthesia. Female sex, history of PONV, motion sickness, nonsmoker status, use of volatile~     agents, duration of anesthesia, opioid administration and laparoscopic surgery are known as~     risk factors for developing PONV. In consequence, patients undergoing laparoscopic~     gynecologic surgery are at high risk for developing PONV. Most of these patients use fentanyl~     based IV-PCA. And it also causes PONV.~      So, we should prevent PONV in these patients by using multimodal or combination therapy.~      Aprepitant is a NK1 receptor antagonist.And it is used to prevent chemotherapy induced nausea~     and vomiting. Many studies using aprepitant to prevent PONV are in progress.~      In this study, we investigate the effect of combining aprepitant with ondansetron in~     high-risk patients for PONV.~   "
127591|NCT01897324|"~     in this study, we are trying to monitor the effect of the addition of growth hormone on the~     different down regulation protocols ( long, short, antagonist and microflare). The outcome~     will be primarily assessed by the clinical pregnancy rates.~   "
127592|NCT01897311|"~     The aim of the study was to evaluate the analgesic effect of transcutaneous electrical nerve~     stimulation High (100 Hz) and low (4 Hz) frequency in postpartum pain after cesarean section.~   "
127593|NCT01897298|"~     This project plans on a training intervention by using public spaces and urban walkable~     trails, adapted to each patient needs and capabilities. Primary objective is to assess 12~     months effectiveness of the intervention with respect to: (primary outcome): physical~     activity level, and (secondary outcomes): COPD admissions, exercise capacity, body~     composition, quality of life, and mental health.~   "
127594|NCT01897285|"~     AQUACEL® foam adhesive dressing is a sterile Hydrofiber® foam wound dressing consisting of a~     waterproof outer polyurethane film, and a multi-layered absorbent pad, having a silicone~     adhesive border. The multi-layered absorbent pad contains a layer of polyurethane foam and a~     non-woven wound contact layer of Hydrofiber® (NaCMC). This dressing product was launched in~     2012. A new source of silicone adhesive is now under assessment for this product. This~     Healthy Volunteer Wear test will form part of the Design Validation for this change in~     supplier and is required to confirm that the new Silicone Adhesive trilaminate supplier can~     coat the silicone adhesive to provide comparable adhesive dressing performance in terms of~     wear time, ease of use and with a similar safety profile in relation to the skin.~   "
127595|NCT01897272|"~     This research study is for patients who are schedule to have carpal tunnel release surgery.~     The investigators have developed this study in order to determine if post-operative splinting~     is effective in improvement of patient outcomes after this surgical procedure. The study is~     being conducted under the direction of Huey Tien, MD. The purpose of this study is to~     determine if post-operative splinting is effective in improving patient outcomes after having~     short-incision carpal tunnel release. The investigators will randomize each patient into~     group 1, splinting after surgery or group 2 no splinting after surgery. Each group will have~     the same outcome measurements done to determine the best outcome of the two groups.~   "
127596|NCT01897259|"~     This is a prospective study where patients with lateral epicondylitis (tennis elbow) will be~     randomized into one of 4 possible treatments. The purpose is to individually examine the~     efficacy of each treatment, and determine if one treatment method is more effective than~     another. The four treatments are: corticosteriod injections, prolotherapy, NSAIDs~     (non-steroidal anti-inflammatory drugs) combined with physical therapy, and a placebo.~   "
127597|NCT01897246|"~     The investigators are comparing post-operative patient-rated functional outcome between~     patients who undergo corrective osteotomy for extra-articular malunited distal radius~     fractures with and without computer assisted pre-operative planning and virtual osteotomy.~   "
127598|NCT01897233|"~     This is a Phase 3, 2-part (Part A and Part B), open-label, multicenter study to evaluate the~     pharmacokinetics, safety, and tolerability of lumacaftor in combination with ivacaftor in~     subjects with cystic fibrosis aged 6 to 11 years who have the F508del-mutation in the cystic~     fibrosis transmembrane conductance regulator (CFTR) gene.~   "
127599|NCT01897220|"~     The aim of the study is to analyze the present use of antithrombotic therapy on a large~     cohort of consecutive cardiacs undergoing non-cardiac surgery. If even and for how long the~     medication was discontinued, if any other antithrombotic therapy was used in the~     perioperative period and prevalence of perioperative complications - especially ischemic or~     bleeding. These complications will be correlated with the pattern of antithrombotic therapy~     administration. Working hypothesis is to obtain a large database of unselected cohort of~     consecutive patients for mapping of this practically important, but in the evidence-based~     medicine, still neglected problem.~   "
127600|NCT01897207|"~     The main aim of this trial is to assess the response rate, the feasibility and toxicity of~     the treatment with antigen loaded Dendritic Cell Vaccination in Prostate Cancer patients.~     Furthermore we want to investigate biological responses by measuring markers of in-vivo and~     ex-vivo immunomodulation.~   "
127613|NCT01897038|"~     This multicenter, open-label study will evaluate the maximum tolerated dose (MTD) and~     dose-limiting toxicities of onartuzumab as single agent or in combination with sorafenib in~     participants with advanced hepatocellular carcinoma. Participants in Cohort 1 will receive~     onartuzumab as single agent on Day 1 of each 21-day cycle. Participants in Cohorts 2 or 3~     will receive onartuzumab on Day 1 of each 21-day cycle in combination with sorafenib 400 mg~     orally daily or twice daily. Anticipated time on study treatment is until disease progression~     or unacceptable toxicity occurs.~   "
139455|NCT01741974|"~     The purpose of this study is to investigate the anti-atherosclerotic and anti-climacteric~     action of natural drug Karinat based on phytoestrogen-rich botanicals in perimenopausal~     women.~   "
127601|NCT01897194|"~     Despite its clinical significance, the pathophysiology of coma is still under investigation~     and the physiology of emergence from coma remains a mystery. Furthermore, predictors of~     emergence from coma, despite their obvious clinical value, remain un-established. Because of~     its low arousal state and hypothesized parallel neurophysiological mechanisms, sleep has been~     studied as both an animal and human model of coma, and awakening from sleep has likewise been~     studied as a surrogate of coma emergence. In this study, we will determine whether certain~     electrographic patterns, known as spectral shifts, which have correlates in normal sleep, are~     predictive of eventual awakening from coma and the time course of this emergence. To detect~     spectral shifts in comatose patients, EEG monitoring must be performed for several days.~     Quick, simple, and reliable EEG recording in the ICU will be enhanced by a small device that~     can be easily and properly positioned on the head by hospital personnel and which lacks~     cumbersome cables or receivers. Traditional EEG monitoring requires placement of up to 25~     wires, which can impede efficient intensive patient care. Our hypothesis is that we can~     detect a difference in spectral shifts in comatose patients who will eventually emerge from~     coma as compared to comatose patients who do not wake up and that a wireless EEG patch-type~     device can effectively make this distinction.~   "
127602|NCT01897181|"~     The purpose of this study is to evaluate the central auditory processing in patients with~     bilateral sensorineural hearing loss and to observe the change of the central auditory~     processing ability after using hearing aids.~   "
127603|NCT01897168|"~     The primary purpose of this study is to determine the effects of early diet on bone health.~   "
127604|NCT01897155|"~     The purpose of this randomized clinical trial is to evaluate the effect of acute arterial~     hypertension maintained during surgery on morphine's requirements in patients undergoing~     laparoscopic cholecystectomy~   "
127605|NCT01897142|"~     The purpose of this study is to determine what the study drug does to the body, what the body~     does to the study drug, and if the study drug is safe and well tolerated when given to adult~     healthy volunteers.~   "
127606|NCT01897129|"~     Purpose Our study involves two hypotheses. One is that genital infection with HPV is~     associated with increased risk of miscarriage and preterm birth. The second hypothesis is~     that human papillomavirus can ascend from the vagina to the uterus through the cervix and~     cross the placental barrier. We wish to verify these hypotheses in our studies.~      This study will determine the prevalence of HPV in Danish pregnant women and examine HPV's~     role in the aetiology of spontaneous abortion and preterm birth.~   "
127607|NCT01897116|"~     This is a Phase I study combining vemurafenib and hydroxychloroquine in the treatment of BRAF~     V600E+ metastatic melanoma.~   "
127608|NCT01897103|"~     The proposed PIVOTAL study will examine a panel of platelet/coagulation activity markers~     during the perioperative period. The goal is to develop a clinically useful assessment of~     platelet/coagulation activity for risk stratification that may ultimately serve as a target~     for therapeutic intervention. This study will enroll 200 patients with peripheral artery~     disease undergoing vascular surgery. PIVOTAL is funded by American Heart Association and is~     scheduled to begin enrollment in July 2013 for approximately two years.~   "
127609|NCT01897090|"~     A 16-week randomized, pilot study to determine if an elimination diet reduces symptoms of~     Crohn's disease. Sixty (60) adult patients (18-75 yrs) with a mild or moderate Crohn's~     Disease Activity Index (CDAI) of 150-450, will be recruited through the GI practices at Johns~     Hopkins University. Patients agree not to be on any other major treatments, with the~     exception of consistent/stable doses of 5-aminosalicylate (ASA) drugs/other medications~     during the course of the study and will obtain their physician's permission.They will be~     divided into a treatment and standard diet group: thirty (30) patients will be on the~     Crohn's Disease Diet (primarily an anti-inflammatory diet that is an elimination diet -~     gluten-free, casein-free based with limited carbohydrate) and thirty (30) patients will be~     given the Dietary Guideline recommendations and similar dietary counseling attention. To~     assess the clinical efficacy and tolerance of the trial population, patients will be~     monitored by two office visits (at 0 and 12 weeks) by visits with the Clinical Research Unit~     (CRU) registered dietitians (RDs) at 0, 6, 12, and 16 weeks (4 weeks after the end of the~     study) for blood and dietary data collection. Clinical endpoints will be Crohn's disease~     Activity Index (CDAI) scores (remission < 150; mild = 150-220; moderate = 220-450; severe =~     450+), C-Reactive Protein (CRP) values (0-0.8 mg/L), sedimentation rate /(male: 15-20 mm/hr,~     female: 20-30 mm/hr)/, possibly interleukin-6(/normal value: <10pg/ml)/, Overall Quality of~     Life (QOL) through the Inflammatory Bowel Disease Questionnaire (IBDQ), Dudley IBD Symptom~     Questionnaire (DISQ) surveys, and Brown's Gastrointestinal Quality of Life (QOL)~     Questionnaire, and health care costs measured by a health care cost questionnaire.~   "
127610|NCT01897077|"~     The purpose of this study is to determine if a new method of administration of peanut~     sublingual immunotherapy, a dissolving peanut film, is effective.~   "
127611|NCT01897064|"~     The aim of this study is to look at the effects of Aerobic Exercise (AE) on daily and~     neurocognitive functioning including memory, attention, the ability to plan activities, and~     learn new information. Participants will be assigned by chance to receive regular care or~     exercise sessions in addition to regular care. This study will allow determining the~     potential positive influence of AE on cognitive and daily functioning in individuals with~     schizophrenia.~   "
127612|NCT01897051|"~     To reduce portal pressure, the only recommended medication is nonselective beta~     blocker(NSBB). However, NSBB has some limitation to apply clinically because of poor response~     rate and compliance.~      Recent literature has supported the role of bacterial translocation as a mediator of~     splanchnic vasodilatation and portal hypertension. This stimulates the release of~     pro-inflammatory cytokines and the activation of the vasodilator NO resulting in a more~     pronounced deterioration of the baseline hyperdynamic circulatory state. Selective gut~     decontamination with Rifaximin can induce inhibition of bacterial translocation and~     associated worsening of portal hypertension. The investigators hypothesized that Rifaximin~     plus NSBB could result in decrease of portal pressure in cirrhotic patients with esophageal~     varices.~   "
127631|NCT01896778|"~     This randomized pilot clinical trial studies body warming in improving blood flow and oxygen~     delivery to tumors in patients with cancer. Heating tumor cells to several degrees above~     normal body temperature may kill tumor cells.~   "
139456|NCT01741961|"~     Long term results after Ahmed glaucoma valve implantation for uncontrolled glaucoma are~     retrospectively examined.~   "
127614|NCT01897025|"~     Stroke is the most common cause of adult disability. Current treatments for functional loss~     of the upper extremity post-stroke remain limited in efficacy, particularly for those with~     moderate to severe impairment.~      Previous studies have demonstrated the efficacy of transcranial direct current stimulation~     (tDCS) for motor recovery post-stroke, a technique of neuromodulation. Motor imagery is~     effective to enhance motor recovery, with activation of neural pathways similar to that of~     motor execution. This treatment is accessible to more severely impaired stroke survivors. Our~     previous studies have demonstrated feasibility and efficacy of motor imagery-based brain~     computer interface (MI-BCI) for post-stroke motor impairment, in which motor imagery is~     detected by surface EEG and translated to execution of the target movement with the aid of an~     arm robot (MIT-Manus).~      In this study, we investigate the feasibility of combining robot-assisted MI-BCI training,~     with tDCS to facilitate post-stroke motor recovery in moderate to severe impairment of upper~     extremity function. We hypothesise that both tDCS-BCI and sham-BCI will improve motor~     function in the stroke-affected arm; but that tDCS-BCI will be more effective than sham-BCI.~     Our secondary aim is to gain insight into the neurophysiological mechanism by comparing the~     cortical excitability changes following sham-BCI vs tDCS-BCI, using transcranial magnetic~     stimulation (TMS).~      We will conduct a randomized, double-blinded study with MI-BCI combined with tDCS (tDCS-BCI)~     vs MI-BCI combined with sham-tDCS (sham tDCS-BCI). Subjects will undergo 10 sessions of tDCS~     each lasting 20 minutes, followed by 40 minutes of robot-assisted MI-BCI training at each~     session. Primary outcome will be functional ability measured by upper extremity component of~     the Fugl-Meyer Assessment. Secondary outcome measures will be the Box & Block Test, Modified~     Ashworth Score (measuring spasticity), grip strength and measures of brain activity including~     transcranial magnetic stimulation (TMS) measures of magnetic resonance imaging (MRI) measures~     including functional MRI and diffusion tensor imaging (DTI).~      This study will be important to develop a new and effective treatment (tDCS-BCI) for~     post-stroke motor impairment.~   "
127615|NCT01897012|"~     This phase I trial studies the side effects and best dose of alisertib and romidepsin in~     treating patients with B-cell or T-cell lymphomas that have returned after a period of~     improvement (relapsed) or have not responded to treatment (refractory). Alisertib may stop~     the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used~     in chemotherapy, such as romidepsin, work in different ways to stop the growth of cancer~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Giving alisertib and romidepsin may be a better treatment for relapsed or~     refractory B-cell or T-cell lymphomas.~   "
127616|NCT01896999|"~     This phase I/II trial studies the side effects and best dose of ipilimumab and nivolumab when~     given together with brentuximab vedotin, and how well they work in treating patients with~     Hodgkin lymphoma that has returned after a period of improvement or has not responded to~     previous treatment. Monoclonal antibodies, such as ipilimumab and nivolumab, may interfere~     with the ability of cancer cells to grow and spread. Brentuximab vedotin is a combining~     monoclonal antibody with an anticancer drug that binds to a protein on the surface of~     lymphoma cells called cluster of differentiation (CD)30 and may kill the cells. It is not~     known whether giving brentuximab vedotin and nivolumab with or without ipilimumab may kill~     more cancer cells.~   "
127617|NCT01896986|"~     In 2007-2009 the investigators conducted a study to determine the immunogenicity response to~     HPV vaccine in special risk patients known to be at increased risk of abnormal cervical~     cytology. The serological response to the vaccine was measured 1 month post the third and~     final dose (n=70) finding a robust response overall.~      The aim of this follow-on study is to provide data on the long-term protection offered by the~     HPV vaccination. The persistence of antibody 5 years post immunisation is unknown and the~     impact on cervical cytology abnormalities in these special risk groups is important.~      The study results will help inform national immunisation program recommendations re- booster~     HPV vaccine doses.~   "
127618|NCT01896973|"~     The HistoSonics' Histotripsy BPH Device, the Vortx Rx, is a portable ultrasound therapy~     device. The purpose of this study is to assess and monitor the performance of the Vortx Rx~     for initial safety and efficacy for the treatment of Benign Prostatic Hyperplasia.~   "
127619|NCT01896960|"~     Hypotension is extremely common after induction of spinal anesthesia for cesarean delivery.~     Anesthetic blockade of the sympathetic outflow of the spinal cord causes vasodilation, and is~     one cause of this hypotension. The higher the spread of the blockade will result in a higher~     incidence of hypotension. Injected hyperbaric medication has about 15 minutes to spread~     within the intrathecal space before it will be taken up by the nerve roots. The time that a~     patient remains in one position after medication injection will affect the spread of the~     resultant anesthetic block. A patient who is left sitting for a longer period of time after~     injection of hyperbaric medication will have a lower level of block than someone who is~     placed supine immediately. In this study, the investigators wish to use up down sequential~     analysis to determine the time period a patient should remain seated after intrathecal~     injection of hyperbaric bupivacaine and fentanyl that will result in a 50% rate of~     hypotension.~   "
127620|NCT01896947|"~     The purpose of this study is to evaluate the diagnostic performance of three Tesla magnetic~     resonance imaging (3T MRI) compared to magnetic resonance arthrogram (MR arthrogram) in~     diagnosing superior labrum anterior posterior (SLAP) lesions. We hypothesize that 3T MRI will~     have non-inferior sensitivity compared to MR arthrogram in diagnosing SLAP lesions utilizing~     arthroscopy as our gold standard test. To evaluate our hypothesis, the investigators will~     include patients suspected to have a SLAP lesion on history and physical examination by a~     fellowship trained orthopaedic surgery. Patients will be offered advanced imaging (both 3T~     MRI and MR arthrogram) as well as arthroscopy for definitive diagnosis and treatment after~     consent is obtained. A fellowship trained musculoskeletal radiologist will perform and~     interpret the magnetic resonance tests while the arthroscopy will be performed by orthopaedic~     surgeons. The diagnostic characteristics of each imaging modality, including sensitivity,~     specificity, negative predictive value, and positive predictive value, will be compared to~     each other.~   "
127621|NCT01896934|"~     The long-term goal of this line of research is to determine if decreased vascular reactivity~     and frontal hypoperfusion is associated with poor response antidepressants. Such perfusion~     deficits could contribute to antidepressant nonresponse as they would hinder improvements in~     dorsal system metabolism seen with antidepressant treatment. The objective of the current~     proposal is to determine if decreased vascular reactivity and frontal hypoperfusion in~     depressed elders predicts and persists with antidepressant nonremission. The investigators~     will pursue the primary aim testing the hypothesis that decreased reactivity and~     hypoperfusion, specifically in the dorsolateral prefrontal cortex and dorsal anterior~     cingulate cortex, predict antidepressant nonremission. The investigators will enroll 40~     depressed elders who will complete clinical, cognitive, and MRI assessments before and after~     a 12-week open-label antidepressant trial of sertraline.~   "
127672|NCT01896245|"~     Anesthesia induction and tracheal intubation can be performed with and without neuromuscular~     blocking agents (NMBAs). Tracheal intubation can be performed with sevoflurane instead of~     NMBAs; intubating conditions are similar and the incidence of vocal cord injuries are~     similar, too.~   "
127622|NCT01896921|"~     This clinical study proposes to evaluate the combination of maraviroc with an integrase~     strand transfer inhibitor (either raltegravir or dolutegravir) in antiretroviral-experienced~     patients to document the efficacy, safety, and tolerability of this combination in order to~     provide clinicians with a treatment regimen that minimizes the risk of metabolic~     complications by avoidance of NRTI/NNRTIs and PIs. The development of an alternative ART~     regimen which lessens the risk of metabolic complications could improve long-term adherence~     and reduce the risk of certain co-morbidities associated with long-term ART use. If this new~     combination is found to be as efficacious as the standard regimen with enhanced tolerability~     and improved metabolic effects, there is great potential for altering the current practice of~     HIV medicine.~   "
127623|NCT01896908|"~     Although half of the patients with HF has normal ejection fraction or slightly altered~     (HF-PEF) and the prognosis differs little from those with reduced ejection fraction, the~     pathophysiology of HF-PEF is still poorly understood.~      Sodium restriction is the most common measure of self-care oriented to HF patients for~     management of congestive episodes. The role of this orientation in the treatment of patients~     with preserved ejection fraction, however, is still unclear. The evaluation of the effects of~     sodium restriction on neurohormonal activation and episodes of decompensation in HF-PEF can~     promote a better understanding of the pathophysiological progression of this complex~     syndrome.~   "
127624|NCT01896895|"~     This phase 3 study will serve to collect efficacy and safety data of two different doses of~     NT 201 in subjects suffering from Bilateral Blepharospasm (BEB) who are BTX treatment-naïve.~      In this study, BTX treatment-naïve subjects are defined as those who have not received BTX~     treatment within the last 12 months for the treatment of BEB. This definition aims to avoid~     bias by comparison of treatment effects in the subject's assessments. Furthermore, this study~     will substantiate the existing efficacy and safety database for the indication BEB.~   "
127625|NCT01896882|"~     Excess dietary sodium can lead to poor outcomes, such as hypertension, edema and increased~     risk for cardiovascular diseases. These complications are associated with end stage renal~     disease (ESRD) progression and mortality in renal patients. This study aims to evaluate the~     effects of nutritional counseling restricting dietary sodium and its relation to clinical and~     diet factors, nutritional knowledge and quality of life in hemodialysis patients.~   "
127626|NCT01896869|"~     This study will enroll patients who have metastatic pancreatic cancer with stable disease on~     FOLFIRINOX chemotherapy. The main purpose of this study is to compare survival between~     patients that receive ipilimumab and a pancreatic tumor vaccine and patients who continue to~     receive FOLFIRINOX.~      Funding Source - FDA OOPD~   "
127627|NCT01896856|"~     This is a phase I/randomized phase II study of the combination of SGI-110 and previously~     treated metastatic colorectal cancer patients. This study will be conducted in two~     components. First, patients will be enrolled in a phase I study of SGI-110 combined with~     irinotecan in a standard 3+3 design. After the maximum tolerated dose (MTD) is determined,~     patients will subsequently be enrolled in a 2:1 randomized phase II study of SGI-110 and~     irinotecan versus the standard of care regorafenib or TAS-102.~   "
127628|NCT01896843|"~     Background:~      - A small brain protein called the metabotropic glutamate receptor subtype 5 (mGluR5) may~     affect several brain diseases such as autism and depression. Researchers will use 2~     radioactive chemicals ([11C]SP203 and [11C]FPEB) and a research drug (STX107) that can attach~     to the receptor, to figure out the best way to use positron emission tomography (PET) to see~     the mGluR5 receptor. They will use scans to monitor where the radioactivity goes.~      Objectives:~      - To find the best way to image the mGluR5 receptor in the brain.~      Eligibility:~      - Healthy volunteers ages 18 to 55.~      Design:~        -  All participants will be screened with a medical exam at visit 1. In later visits, they~          may have a PET scan, when two small tubes are placed under the skin and they lie down in~          a scanner. They may have an MRI scan, when they lie down in a scanner.~        -  Part 1 participants will have 2 more visits. They will have a PET brain scan using~          [11C]FPEB and will have blood drawn. Then they will have an MRI brain scan.~        -  Part 2 participants will have 1 more visit, with a whole body PET scan using [11C]FPEB~          and blood drawn.~        -  Part 3 participants will have 4 more visits, including 1 overnight stay at a hospital.~          Over all the visits, they will have 4 PET scans and 1 MRI brain scan. They will receive~          the research drug and injections of both chemicals. Blood will be drawn during the~          scans.~   "
127629|NCT01896830|"~     The aim of the study is to evaluate a candidate C. difficile Toxoid Vaccine in the Japanese~     population.~      Primary objectives:~        -  To describe the safety profile of all subjects who receive at least 1 injection~        -  To describe the immunogenicity to toxin A and toxin B in all subjects from serum samples~          obtained on Days 0, 14, 30, and 60.~   "
127630|NCT01896791|"~     Climacteric or Menopausal Transition is defined as the time period where there is a change to~     non-reproductive reproductive life, with extension of variable length. During this period,~     and after the establishment of Menopause and non-functioning ovarian, the appearance of~     various symptoms that express the depletion of ovarian follicles is common; among these~     symptoms, the most frequently reported by women are vasomotor symptoms or hot flashes. In~     addition to hormonal therapy, other medications have been employed in an attempt to improve~     these symptoms; although they present better results than placebo, yet have little clinical~     impact in reducing vasomotor symptoms. Therefore, this gap allows the evaluation of~     alternative therapies, such as Transcranial Direct Current Stimulation (tDCS). The rationale~     for studying the effect of this technique in this context is its possible autonomic~     modulatory effect. What reinforces the choice of this technique is the fact that it~     demonstrated efficacy in other pathologies such as depression, pain, Parkinson's disease,~     among others. Transcranial direct current stimulation (tDCS) is a renewed method of~     non-invasive brain modulation. It is based on a transcranial application of weak direct~     currents in a non-invasive, simple and painless manner. Its use in the treatment of vasomotor~     symptoms has not been studied. The objective of this study is to evaluate the improvement of~     vasomotor symptoms in postmenopausal women, after application of tDCS, and compare them to a~     control group. This Randomized Clinical Trial will be held in female postmenopausal patients,~     followed in the outpatient Menopause Clinic of Obstetrics and Gynecology Service, Hospital de~     Clinicas de Porto Alegre. From these results, it is expected to present a new therapeutic~     option in the treatment of vasomotor symptoms.~   "
127632|NCT01896765|"~     It is unknown, if a modern prevention program, including intense nurse-coordinated education~     sessions, regular telephone contacts and a telephone hotline for 12 months, significantly~     reduces cardiovascular risk factors, clinical events and quality of life in myocardial~     infarction patients compared to usual care. Furthermore, actually no data on the additional~     effects and the feasibility of longterm telemetric care of cardiovascular risk factors exist.~      The primary hypothesis to be tested is that an intensive longterm prevention program compared~     to the standard of medical care, will achieve better risk factor control and consecutively~     less clinical adverse events in patients after myocardial infarctions. A nurse-coordinated~     program and telemetric prevention will be analyzed.~   "
127633|NCT01896752|"~     High-dose methotrexate therapy (HDMTX) is an important part of treatment of childhood acute~     lymphoblastic leukemia (ALL). HDMTX would be improved substantially if it were possible to~     predict the clearance of MTX for each patient and use this to tailor an individualized dosing~     of the drug. However, only about 3.7, 0.2, and 2% of the inter-individual variation in MTX~     clearance is explained by age, gender and ancestry, respectively. Genetic variation seems to~     explain about 10% of this difference, and SNPs in genes encoding transporter proteins (e.g.~     organic anion transporter 1B1 (OATP1B1) and reduced folate carrier (RFC)) are suggested to~     have a particular large impact. A serious limitation to the applicability of SNPs in~     prediction of MTX pharmacokinetics, however, is the substantial intra-individual variation in~     MTX clearance.~      The intra-individual variation in MTX clearance is related to renal function but a large~     amount of a HDMTX dose also enters the liver, where it is metabolized to 7-hydroxy MTX and~     probably also undergoes enterohepatic circulation. Thus, the aim of this study is to~     determine the role of the liver and renal function in MTX pharmacokinetics, and evaluate the~     predictive potential of pharmacogenetic (e.g. the rfc SNP) and pharmacokinetic parameters of~     MTX elimination during HDMTX.~   "
127634|NCT01896739|"~     To evaluate and compare the immunogenicity of Eutravac (Diphtheria-Tetanus-acellular~     Pertussis [DTaP] Hepatitis B [HB] combined) vaccine with separate but simultaneous~     administrations of DTaP and HB vaccine each administered to healthy infants, as measured by~     seroprotection/vaccine response rates 4-8 weeks post-final immunisation.~   "
127635|NCT01896726|"~     The main purpose of this study is to find out how the body absorbs and breaks down a common~     birth control pill called Microgynon when it is given with the study drug called baricitinib.~     Safety and the body's ability to tolerate baricitinib and Microgynon will also be studied.~     The study will last approximately 6 weeks for each participant.~   "
127636|NCT01896713|"~     MultiSpectral 3 Tesla MRI (MS3TMRI) can increase the yield of Trans Rectal Ultrasound Biopsy~     (TRUSBx) to improve identification of patients on active surveillance requiring treatment.~   "
127637|NCT01896700|"~     Methylphenidate is an amphetamine-like psychomotor stimulant drug currently approved for the~     treatment of attention-deficit hyperactivity disorder (ADHD), postural orthostasis~     tachycardia syndrome and narcolepsy. It is also often prescribed off label to people with MS~     to improve fatigue. It is proposed that methylphenidate may also improve imbalance and~     walking deficits in MS by improving concentration and central integration, one of the primary~     mechanisms thought to underlie imbalance and walking deficits in MS.~   "
127638|NCT01896687|"~     This pilot study will evaluate Scrambler therapy and Sham treatment on levels of low back~     pain, pain sensitivity and mRNA expression of pain sensitivity candidate genes.~   "
127639|NCT01896674|"~     The purpose of this study was to compare FBP-, hybrid IR-, and IMR techniques to assess their~     role in the identification of coronary artery disease and abnormalities in cardiac~     structures.~   "
127640|NCT01896661|"~     Obstructive sleep apnea and hypertension are well-known cardiovascular risk factors. Their~     control could reduce the burden of heart disease across populations. There are several drugs~     to control hypertension, but the only consistently beneficial treatment to reduce apneas is~     continuous positive airway pressure. The demonstration that one drug could improve sleep~     apnea and hypertension would support a novel approach in the treatment of both diseases. The~     role of fluid retention in sleep apnea is known for several decades. The role of diuretics is~     well established in hypertension but was never appropriately tested in sleep apnea. Besides~     to test the efficacy of these drugs, this study will help to understand the mechanisms that~     link hypertension and sleep apnea and its treatment.~   "
127641|NCT01896648|"~     Type 2 diabetes mellitus is becoming an increasingly problem for public health and it is~     related with various complications such as sexual problems. The prevalence of erectile~     dysfunction has been widely studied in men as a complication of diabetes; the prevalence of~     sexual dysfunction in women, instead, has not been well investigated. The aim of this study~     is to evaluate the prevalence of sexual dysfunction in type 2 diabetic women using~     international validated questionnaires.~   "
127642|NCT01896635|"~     The purpose of this study is to determine whether fecal microbiota transplantation (FMT) is~     safe and efficacious in the treatment of chronic active ulcerative colitis (UC) by conducting~     a randomised controlled trial~   "
127643|NCT01896622|"~     Background:~      - People who have the human immunodeficiency virus (HIV) often take several medications to~     control their disease. They may also need to take medicine to prevent blood clots. Taking~     both kinds of medicine together can cause bleeding or other problems. But this might not~     happen if the medications are taken at different times. Researchers will study two particular~     HIV drugs (ritonavir and cobicistat) and how they interact with blood clot medications.~      Objectives:~      -To understand how HIV medicine and blood clot medicine interact, so doctors can choose what~     to prescribe for people who take both.~      Eligibility:~      - Healthy adults between 18 and 70 years old who are not on any medications.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood samples~          will be collected. Urine samples will be collected from participants who might become~          pregnant.~        -  Participants will visit the National Institutes of Health 7 times after the screening~          visit. Three visits will last about 12 hours. The other 4 will last about 1 hour.~        -  Participants will take a daily dose of either study medication for 22 days. They will~          keep a diary of medicine they take and any side effects.~        -  Treatment will be monitored with blood tests over about 2 months.~        -  When the study of one drug is completed, the next drug study will begin with a different~          group of participants.~   "
127644|NCT01896609|"~     A single Center, Prospective Phase IV, Open-Label, Controlled, Randomized Trial comparing the~     efficacy, safety, and tolerability of Quadritherapy regimen (Reiferon Retard® , Ribavirin ,~     Nitazoxanide and Alfacalcidol (Bon-One ® ) versus Triple therapy regimen (Reiferon Retard® ,~     Ribavirin and Nitazoxanide) versus the standard of care regimen(Reiferon Retard® and~     Ribavirin) in the treatment of Naïve chronic hepatitis C among the Egyptian population.~     Effectiveness will be evaluated based on Sustained Virological Response (SVR) .~      PRIMARY OBJECTIVE(S): The primary objectives of this trial are as follows:~        -  To compare the efficacy of the three treatment arms in naïve Chronic Hepatitis C Virus~          (HCV) genotype 4 patients by evaluating the sustained virological response ( SVR) at~          week 60 ( 3 months after end of treatment period)~        -  Identify optimum treatment protocol for HCV genotype 4 in respect to used combination of~          medications~        -  Whether adding vitamin D, a potent immunomodulator, could improve viral response.~      STUDY DESIGN: This is a phase IV, single center, open labeled, randomized (1:1:1) controlled~     study.~      NUMBER OF EVALUABLE SUBJECTS: 300 NUMBER OF CENTER/S: 1 Country:Egypt DURATION OF THE STUDY:~     94 weeks TREATMENT: randomized 1:1:1 ratio into 3 Arms SUBJECT POPULATION: male or female~     subjects assessed by BMI less than 35, between the ages of 20 and 50 years. Subjects have to~     be diagnosed as Naïve Chronic Hepatitis C genotype 4 patients with compensated liver disease~     assessed by hematological and biochemical tests.~      - DURATION OF THE STUDY: 94 weeks as follows:~      Estimated Enrollment Duration: 16 weeks Collection of last Case Report Form (CRF) : 2 weeks~     from Last patient out. Queries Resolution: 4 weeks from Collection of last CRF. Database lock~     planned date: 2 weeks from Quires resolution. Final Study Report: 8 weeks from Database lock.~     Estimated duration of subject participation: 62 weeks as follows;~        -  Screening period per subject = 2 weeks~        -  Treatment phase per subject = 48 weeks~        -  Follow-up phase per subject = 12 weeks~      N.B : Each patient will receive medications for Maximum 48 weeks if his/her Polymerase Chain~     Reaction (PCR) -ve at weeks 12 and 24 , and if his/her PCR +ve at week 12 or week 24 the~     treatment will be stopped .~   "
127645|NCT01896596|"~     In the UK, infants currently receive a 5-in-1 vaccine (Pediacel) at 2, 3 and 4 months of age,~     which protects against diphtheria, tetanus, pertussis (whooping cough), polio and Haemophilus~     influenzae type b (Hib). Infants also routinely receive a meningococcal group C vaccine~     (MenC) at 3 and 4 months and a 13-valent pneumococcal vaccine (Prevenar13) at 2 and 4 months~     of age. This study aims to offer infants a 6-in-1 vaccine (Infanrix-Hexa)that also helps~     protect against hepatitis B alongside the other routine vaccinations in the UK infant~     immunisation schedule and assess their immune responses to the different vaccines. Hepatitis~     B virus infects the liver and usually affects adults, but children can be infected through~     close contact with carriers of the virus. Children with hepatitis B infection may not have~     symptoms for many years but may go on to develop liver failure, cirrhosis and cancer. Many~     other countries already use Infanrix-Hexa and this study is being undertaken to help decide~     whether the UK can do the same. Babies taking part in this study will receive Infanrix-Hexa~     instead of Pediacel. All other vaccines given will be the same as in the routine schedule but~     will include one MenC vaccine instead of 2 doses because the UK infant immunisation schedule~     is soon going to change so that all babies will receive only one MenC vaccine at 3 months of~     age.~      There are currently several licensed MenC vaccines that can be given to babies. In order to~     check whether there are differences in protection, babies taking part will randomly receive~     one of 3 MenC-containing vaccines: NeisVacC, Menjugate or Menitorix. Studies have already~     shown that one dose of Neis-Vac or Menjugate given to babies at 3 months provides similar~     protection against MenC infection as two doses given at 3 and 4 months. Menitorix protects~     against both Hib and MenC, so babies in the group receiving MenitorixTM will have an extra~     dose of Hib which is also included in Infanrix-Hexa but might have a lower antibody response~     to MenC compared to the other two MenC vaccines, although all infants should be~     well-protected after their 12-month booster vaccinations, which also contain Menitorix.~   "
127646|NCT01896583|"~     This trial will evaluate the effect of ASP7147 on daily abdominal pain due to IBS-D during 4~     weeks of treatment. It will also evaluate safety and tolerability in patients with IBS-D over~     the 4-week treatment period.~   "
127647|NCT01896570|"~     In this study, the investigators aim to examine the prognostic role of subsequent Atrial~     Tachycardias (ATs) in the mechanisms of atrial fibrillation (AF). Therefore, the~     investigators compare patients who were randomly assigned to either undergo cardioversion~     after AF has been terminated to AT or further ablation until the achievement of sinus rhythm.~   "
127648|NCT01896557|"~     Previous reports have shown a possible drug interaction between clopidogrel and proton pump~     inhibitors (PPI´s), which could result in increased number of adverse cardiovascular events~     among patients on dual antiplatelet therapy(DAPT). Because of this, ranitidin has been~     proposed as an alternative drug to PPI´s for prophylaxis of gastrointestinal bleeding in~     patients who need DAPT. The study´s aim is to test the hypothesis that ranitidin doesn´t have~     any influence on clopidogrel pharmacodynamic.~   "
127649|NCT01896544|"~     Sepsis in a clinical entity that occurs in patients with serious infections. Though the~     severity of illness may vary, every year, approximately 1.6 million Americans are treated for~     sepsis. Even with timely interventions, anywhere from 16% to >80% of patients with sepsis~     will not survive. Immune dysfunction is thought to play a critical role in the ability for~     infections to evolve into sepsis and to eventually lead to death. Recently, vitamin D has~     been identified as a key regulator of the immune system. While it remains unclear whether~     optimizing vitamin D status may improve outcomes in sepsis, little is known about the effects~     of vitamin D supplementation in patients with severe infections. As such, our goal is to~     study whether high doses of cholecalciferol (vitamin D3) can improve vitamin D status and~     boost certain aspects of the immune system in patients with sepsis.~   "
127650|NCT01896531|"~     This multicenter, randomized, double-blind, placebo-controlled study will evaluate the~     efficacy of GDC-0068 in combination with oxaliplatin, 5-fluorouracil, and leucovorin~     (modified FOLFOX6 [mFOLFOX6]) chemotherapy in participants with advanced or metastatic~     gastric or gastroesophageal junction (GEJ) cancer. Participants will be randomized to receive~     either GDC-0068 or placebo orally daily on Days 1 to 7 of each 14-day cycle in combination~     with mFOLFOX6 on Day 1 of each cycle. Anticipated time on study treatment is until disease~     progression or unacceptable toxicity occurs (up to approximately 2 years).~   "
127651|NCT01896518|"~     The overall aim of the current study is to determine if the use of nicotine containing~     products by caregivers who smoke and who are not interested in quitting, is effective in~     reducing children's secondhand smoke exposure.~   "
127652|NCT01896505|"~     The purpose of this research study is to find out more information such as: to determine the~     effects of high and low fat foods on the pharmacokinetics (PK) of oral KPT-330 tablets, to~     compare PK of capsules and tablets, to assess the effects of KPT-330 on cellular morphology~     and biomarker changes on sarcoma biopsy specimens (in patients who can safely undergo~     biopsy).~   "
127653|NCT01896492|"~     Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders, affecting~     approximately 6-10% of women of reproductive age. Anovulation, infertility and~     hyperandrogenism often co-exist with hyperinsulinaemia and insulin resistance .~      Clomiphene citrate remains the standard drug for induction or augmentation of ovulation.~     However, it is not equally effective in all situations, and therefore it may require~     additional expensive drugs such as N-acetyl cysteine, as an antioxidant, has been suggested~     as an adjuvant in clomiphene-resistant cases .NAC may also improve the circulating level of~     insulin and insulin sensitivity in hyperinsulinaemic women with PCOS, and may be useful for~     the treatment of insulin resistance by ameliorating the homocysteine and lipid profile in~     PCOS .~   "
127655|NCT01896466|"~     The purpose of this study is twofold:~        1. Establish baseline measures of gait performance in healthy young and older adults, and~          older adults with a history of falls.~        2. Investigate the effects of gait and balance training with and without cranial nerve~          noninvasive neuromodulation (CN-NINM) on postural balance and gait performance in older~          adults.~      For the second purpose, the study will incorporate a placebo-controlled design to evaluate~     the effects of CN-NINM augmented exercise compared to physical exercises alone. Both groups~     will perform gait and postural balance training (outlined in more detail below) but will~     differ in the stimulation level of the PoNS device. The investigators will use the results of~     this study as a first step toward evaluating the benefits of CN-NINM in a falls prevention~     program.~   "
127656|NCT01896453|"~     The purpose of this study is to evaluate the efficacy of brain and peripheral electrical~     stimulation on chronic non-specific low back pain patients.~   "
127657|NCT01896440|"~     We will study the effects of ondansetron on measurements of electrical activity in the heart~     to make sure doses we are using to prevent nausea and vomiting in children receiving~     chemotherapy are safe.~   "
127658|NCT01896427|"~     In some cases, impacted wisdom teeth should be extracted. Surgical extraction of these~     impacted third molars may provide special complication as pain, swelling, and trismus. In~     previous studies, some techniques as sutureless flap closure, modified flap designing,~     antibiotic usage, and injection of corticosteroids were presented. These methods are reducing~     post operative complications to moderate level. In this study, pain, swelling, trismus,~     general patients' satisfaction, and associated quality of life after the surgical removal of~     third mandibular impacted molars will be compared while injection of dexamethasone (8mg) does~     not need excessive time, effort, and equipments and it will be injected in numbness area into~     medial pterygoid muscle and pterygomandibular space to current corticosteroid injecting~     non-corticosteroid methods. To achieve this aim, 75 non pregnant participants have single~     impacted mandibular third molar in healthy and without pericoronitis manner, after provision~     of written informed consent will be entered to the study. During the study, unwilling~     participants to continue the study and those with abnormality of wound healing process will~     be excluded. The included participants will be assigned into three 25-people groups. The~     surgeries were done by 3 same instructed experienced oral and maxillofacial residents. After~     the surgery pain, swelling, trismus, general patients' satisfaction, and associated quality~     of life were evaluated using interview of questionnaire in 48 hour, 96 hour, and one week~     period of time. The comparison was done between these three groups.~   "
127659|NCT01896414|"~     The metabolic syndrome raises the risk of heart disease and is currently at epidemic~     proportions in the U.S. It consists of 3 of the following components: central obesity, high~     triglycerides, low HDL, abnormal blood pressure and impaired fasting glucose levels. Previous~     studies have suggested that omega-3 fish oil may influence some of these components but the~     mechanisms involved are not well understood. Therefore, this proposal will investigate how~     omega-3 fish oils affect inflammation, lipids and fat breakdown by comparing it to placebo.~     Favorable outcomes from this study could translate into a new approach to improve heart~     disease risk in men and women with the metabolic syndrome.~   "
127660|NCT01896401|"~     The InSeal vascular closure device (VCD)is assessed as percutaneous closure of artery access~     sites for quick hemostasis and ambulation in patients who have undergone large bore~     endovascular catheterization procedures.~      The study hypothesis is that the VCD is safe and efficaient in achieving hemostasis in the~     study population.~   "
127661|NCT01896388|"~     Accumulating evidence suggests a key role of the N-methyl-D-aspartate (NMDA) receptor in the~     pathophysiology of post-traumatic stress disorder (PTSD). Recent studies suggest that the~     NMDA receptor antagonist ifenprodil tartrate may be a potential therapeutic drug for PTSD.~     The purpose of this study is to confirm whether ifenprodil tartrate is effective in the~     treatment of adolescents PTSD patients. If ifenprodil tartrate is effective in these~     patients, this study contributes to the development of novel therapeutic drugs for PTSD.~   "
127662|NCT01896375|"~     Present study is conducted on Gutkha and Pan Masala users to find out the impact of ban on~     them. It will also try to find out awareness about ban and source of information for the~     same. Availability of Gutkha and Pan Masala in post ban period will also be assessed.~   "
127663|NCT01896362|"~     The aim of this work was to investigate the healthcare professionals' knowledge about~     leishmaniasis in Divinópolis, an endemic county of Minas Gerais state, Brazil.~   "
127664|NCT01896349|"~     The purpose of this study is to determine whether combination of antidepressant drugs plus~     interpersonal psychotherapy is superior to antidepressant drugs alone in treatment resistant~     depression.~   "
127665|NCT01896336|"~     The purpose of this study is to evaluate the efficacy and safety of sublingual zolpidem~     presentation 5 mg in the induction of sleep in patients with primary insomnia.~   "
127666|NCT01896323|"~     This is a single-center open-label study to compare how CC-223 (the study drug being~     investigated) interacts with the drug ketoconazole.~   "
127667|NCT01896310|"~     The aim of the present study was to propose a new pCLE classification of gastric pit patterns~     and vessel architecture, and to assess the accuracy and interobserver agreement of this new~     pCLE classification system in the stomach.~   "
127668|NCT01896297|"~     The goal of this study is to assess dabigatran pharmacokinetics in NVAF subjects with severe~     renal impairment defined as creatinine clearance between 15 and 30 mL/min calculated by~     Cockcroft-Gault formula.~      The dabigatran etexilate dose of 75 mg BID was approved by the FDA for NVAF patients with~     severe renal impairment (CrCl 15-30 mL/min) , based on pharmacokinetic modeling and~     simulation.~   "
127669|NCT01896284|"~     Patients with neovascular age-related macular degeneration who do not respond to usual~     treatment with conventional medications may respond to a new drug of the same class which is~     designed to block a larger fraction of proangiogenic factors.~   "
127670|NCT01896271|"~     In this i-SABR (immunotherapy + Stereotactic Ablative Body Radiation) trial, the stereotactic~     radiation to multiple metastatic sites is delivered not only to eradicate sites of bulky~     progressive disease, but also to provide antigen presentation and immune stimulation which is~     expected to act synergistically when immediately followed by the non-specific immune~     stimulation provided by treatment with HD IL-2 and thereby increase the response rate and~     complete response for metastatic clear cell renal cell cancer patients. Both HD IL-2 and SABR~     are FDA approved therapeutic cancer treatment~   "
127675|NCT01896206|"~     This study will compare accuracy of a newly developed monitor for continuous non-invasive~     blood pressure monitoring (CNAP™ Monitor 500; CNSystems Medizintechnik AG, Graz, Austria)~     that provides beat-to-beat BP readings with two of the current and more commonly used~     intermittently oscillometric non-invasive blood pressure device (NIBP), and the invasive~     arterial line (IBP).~   "
127676|NCT01896193|"~     This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir plus~     ribavirin administered for 16 weeks and 24 weeks in participants with chronic genotype 1~     (GT1) or genotype 3 (GT3) hepatitis C virus (HCV) infection.~   "
127677|NCT01896180|"~     This is a pilot, proof of concept study to evaluate the safety and efficacy of ALZ-1101 dosed~     once daily for 28 days compared to latanoprost 0.005% ophthalmic solution in patients with~     elevated intraocular pressure not adequately controlled with latanoprost.~   "
127678|NCT01896167|"~     In this study the investigators will investigate the following hypothesis~        -  that hypoxia induce migraine headache and migraine aura~        -  the aura phase is associated with a spreading reduction in cerebral blood flow~        -  the migraine headache is associated with dilatation of intra- and extracerebral arteries~        -  the migraine headache is associated with changes in brain metabolism~        -  the pre-ictal stage of a migraine attack with aura is associated with specific patterns~          in neural activity.~   "
127679|NCT01896154|"~     The aim of the study is to estimate the effect size of a 5-week consumption period of~     different dietary non-digestible polysaccharides (NPS) on antibody response to influenza~     vaccination and cellular immunity of healthy volunteers (aged ≥ 50) for clarifying whether~     these NPS may enable enhancement of immune defence and to estimate the sample size for a~     confirmative trial. Furthermore the effects on faecal microbiota and its metabolites will be~     investigated.~   "
127680|NCT01896128|"~     Armodafinil is an FDA approved medication with wakefulness-promoting properties. It is a~     relatively safe agent with interesting neurochemical effects on the catecholamine system,~     producing an improvement in cognitive function, particularly working memory in humans. When~     combined with intensive task-related training, armodafinil may accelerate motor recovery in~     chronic stroke patients.~      The primary aim of this study is to determine whether administration of armodafinil during~     subacute post-stroke rehabilitation will augment cortical plasticity and enhance motor~     recovery. The primary hypothesis suggests that cortical plasticity will be enhanced by~     armodafinil and, therefore, will induce an improvement in motor function and better~     performances on measures of motor control.~   "
127681|NCT01896115|"~     The objective of the study is to compare different deep brain stimulation (DBS) settings~     using the commercially approved Boston Scientific Neuromodulation Vercise system.~   "
127682|NCT01896102|"~     This trial will assess the efficacy and safety of autologous CD34+ hematopoietic stem cells,~     transduced ex-vivo with Lenti-D lentiviral vector, for the treatment of cerebral~     adrenoleukodystrophy (CALD). A subject's blood stem cells will be collected and modified~     (transduced) using the Lenti-D lentiviral vector encoding human adrenoleukodystrophy protein.~     After modification (transduction) with the Lenti-D lentiviral vector, the cells will be~     transplanted back into the subject following myeloablative conditioning.~   "
127683|NCT01896089|"~     This is a prospective, multi-center, observational study to determine if a combination of~     desensitization and enrollment in a regional kidney paired donor (KPD) exchange program~     improves the overall rate of kidney transplantation in sensitized patients.~   "
127684|NCT01896076|"~     Caudal anesthesia is commonly employed in pediatrics to produce postoperative analgesia in~     low abdominal or urologic surgery.~      An exact understanding of the anatomy of the sacral area including sacral hiatus and~     surrounding structures is crucial to the success of caudal block.~      The aim of this study is to evaluate the anatomy of the caudal space in pediatrics by~     ultrasound evaluation.~   "
127685|NCT01896063|"~     Insomnia is a common clinical disease.The serious patients could not sleep all night, often~     accompanied by headache, dizziness, forgetfulness and so on. All of these increase the mental~     burden of insomnia patients and seriously affected the normal work and quality of life of~     patients. Modern medical treatment to treat insomnia is using sedative and hypnotic drugs,~     mainly benzodiazepine, zopiclone. But long-term use of these drugs can induce the adverse~     reactions, including resistance, dependence and addiction. Many articles indicate that~     electroacupuncture can effectively improve insomnia, play the role of sedative and hypnotic~     effect and avoid many adverse reactions and side effects. Then there are no more objective~     indicators to affirm that which part of brain takes place the appropriate changes when~     electroacupuncture induces the sedative effect. So we designed this experiment.~   "
127686|NCT01896050|"~     Early stage hormone receptor positive breast cancer is typically treated with adjuvant~     endocrine therapy in order to decrease risk of breast cancer recurrence and to improve~     overall survival from the disease. Typical agents used for treatment include tamoxifen and~     the aromatase inhibitors. In postmenopausal women, aromatase inhibitor therapy is~     increasingly common because it is associated with fewer long-term serious toxicities compared~     to tamoxifen. However, aromatase inhibitors cause arthralgias in 40-50% of patients, which~     can influence adherence to therapy and can lead to treatment discontinuation in a minority of~     cases. The mechanism underlying development of this toxicity remains unclear, and predictors~     of who will develop these symptoms remain undefined. Initial reports suggest that grip~     strength decreases during aromatase inhibitor therapy, and that body-mass index may influence~     development of this symptom. Therefore, this longitudinal study has been developed to~     determine change in grip strength over time in women treated with aromatase inhibitors and~     tamoxifen, as well as to identify potential associations between change in grip strength and~     BMI. Patient self-reported symptoms will also be collected. A total of 115 women with early~     stage breast cancer who are initiating therapy with either an aromatase inhibitor or~     tamoxifen will be enrolled.~   "
127697|NCT01895907|"~     The purpose of this study is to examine if Special Olympic athletes's life participation~     improves through involvement with Special Olympics. This project will be undertaken in~     coordination with Special Olympics entities from Texas and around the nation to determine how~     involvement in Special Olympics improves the strengths and limitations of their athletes. The~     Short Child Occupational Profile (SCOPE) will be used to gather this information from the~     parents and coaches. The SCOPE measures the impact that personal and environmental factors~     have on a child or youth's occupational participation.~   "
127687|NCT01896037|"~     People with a spinal cord injury (SCI) characteristically have low levels of high-density~     lipoprotein-cholesterol (HDL-c; good cholesterol) and high levels of low-density~     lipoprotein-cholesterol (LDL-c; bad cholesterol), and are at a higher risk of developing~     cardiovascular health problems, such as heart disease, heart attack and stroke, than the~     able-bodied population. A common way for able-bodied people to improve their lipid profile is~     through exercise; however, SCI people, especially tetraplegics, are often unable to achieve~     and maintain a level of exercise needed to obtain these benefits. It is therefore clinically~     important to find an effective, safe and inexpensive method of increasing HDL-c levels in~     people with chronic tetraplegia. This study will investigate the effects of omega-3 fatty~     acid supplementation on the lipid profile of people with tetraplegia. The investigators~     hypothesize that 5 months of daily consumption of high doses of omega-3 fatty acids will~     increase plasma levels of HDL-c in those with tetraplegia, leading to decreased risk of~     cardiovascular health issues.~   "
127688|NCT01896024|"~     The present research aims at examining the effectiveness of a specific set of therapist~     relational interventions and attitudes, called the Motive-Oriented Therapeutic Relationship~     (MOTR), based on Plan Analysis (Caspar, 2007) in the early-phase treatment of patients~     diagnosed with Borderline Personality Disorder.~      The investigators intend to include N = 80 outpatients diagnosed with Borderline Personality~     Disorder, consulting at the Outpatient Personality Disorder Program of the Karl Jaspers~     Clinical Unit, in collaboration with the Institute of Psychotherapy, at the Department of~     Psychiatry-CHUV, University of Lausanne and in collaboration with the University of Berne,~     Switzerland. Patients are assigned by chance to two treatment conditions 1) Control condition~     (General Psychiatric Management; Gunderson & Links, 2008) and 2) MOTR-condition. The~     investigators hypothesize better results in the MOTR-condition, as compared to the control~     condition in terms of symptom reduction pre-post.~      The conduct of the study represents a significant contribution to the understanding and~     enhancement of relationship aspects in the treatment of patients diagnosed with Borderline~     Personality Disorder which may be of potential benefit for these patients.~   "
127689|NCT01896011|"~     Atypical femur (thigh bone) fractures (AFFs) are uncommon low-trauma fractures which often~     occur without warning, are highly debilitating, and are slow to heal. As physicians learn~     more about them, AFFs are increasingly being identified prior to a total break. However,~     there's no evidence on the best way to treat these non-displaced AFFs. One option is~     teriparatide, an osteoporosis medication that can build new bone. Investigators will conduct~     a double blind randomized placebo controlled trial to examine whether teriparatide use in AFF~     patients with an incomplete break will help accelerate fracture healing and prevent surgical~     intervention. Co-primary outcomes include change in WOMAC scores from baseline to 12 months~     and number of participants requiring surgical intervention at 12 months. Investigators will~     recruit 60 women and men over the age of 30 who have experienced an incomplete AFF.~     Participants will be randomly assigned to either teriparatide (20 mcg/day) or placebo (using~     an identical injection pen) for up to 2 years. As AFFs are highly debilitating, a trial~     examining the use of Teriparatide in this population is urgently needed.~   "
127690|NCT01895998|"~     The proposed research study is a cross-sectional study enrolling young children with sickle~     cell disease between 5 and 12 years of age. They will be screened as outpatients for consent~     to perform pulmonary function testing (PFT) and echocardiography. In addition, the degree of~     bronchodilator response will be assessed at each session. To estimate presence of pulmonary~     hypertension, echocardiography will be performed at the time of PFT measures.~      Study Design:~        1. Enroll children aged 5 to 12 years of age with sickle cell disease (HbSS, HbSC, HbS beta~          plus thalassemia, HbS beta zero thalassemia, and HbS OArab) who are established patients~          within the Duke Pediatric Sickle Cell Clinic.~        2. Perform a chart review of all enrolled subjects to obtain specific details regarding~          birth history, nutritional status (weight, height), family history, sickle cell~          genotype, parental smoking history, recent laboratory parameters, parental smoking~          history, any concurrent conditions (atopy, asthma, airway anomaly), history of sickle~          cell complications and prescribed medications.~        3. Perform spirometry and plethysmography with the administration of albuterol.~        4. Before or after completion the PFT session, the patient will have echocardiography in~          the PFT lab area~        5. Using medical record information, determine number of hospitalizations for any pulmonary~          symptoms indicative of acute chest syndrome (ACS) (dyspnea, fever, wheezing, hypoxia,~          cough, chest pain). In addition, we will track any respiratory or cardiac symptoms or~          therapies for each subject 6 years after enrollment up to age 18 years using the~          registry.~        6. As standard of care, refer any child identified as having lung disease or pulmonary~          hypertension to a pediatric pulmonologist and/or cardiologist for monitoring, treatment~          and ongoing care.~   "
127691|NCT01895985|"~     The objective of this study is to evaluate the effect of latanoprostene bunod dosed once~     daily (QD) in reducing intraocular pressure (IOP) measured over a 24-hour period in healthy~     subjects.~   "
127692|NCT01895972|"~     The objective of this study is to demonstrate the clinical safety of latanoprostene bunod~     0.024% once daily (QD) over a 1-year treatment period.~   "
127693|NCT01895959|"~     The purpose of this study is to identify novel imaging markers for characterizing the~     biochemical profiles in synovial fluid and cartilage matrix in OA knee joints after~     intra-articular HA (Euflexxa) injection using high field NMR and MRI techniques.~      We hypothesize that:~        1. High-field HRMAS NMR spectroscopy will provide sensitive measures for biochemical~          changes within knee synovial fluid after HA injection;~        2. Baseline HRMAS spectroscopy, in particular N-acetyl peaks, as well as early changes of~          glutamate will predict patient response of pain relief after HA injection;~        3. MR cartilage T1p and T2 quantifications will provide sensitive measures for biochemical~          changes within knee cartilage matrix after HA injection. Specifically cartilage T1p and~          T2 will decrease in patients who respond to the treatment, indicating potential~          beneficial effects of HA injection to cartilage preservation.~   "
127694|NCT01895946|"~     Comparison of Two Formulations of AZD5363 and the Effect of Food on Pharmacokinetic Exposure,~     Safety and Tolerability~   "
127695|NCT01895933|"~     This clinical trial is intended to evaluate the impact, efficacy, and safety of Chitosan~     formulated adhesion inhibitor, SurgiShield when used in the process of wound healing after~     endoscopic sinus surgery.~   "
127696|NCT01895920|"~     This project aims at characterizing HIV-1 viral biofilms structural and functional properties~     and at deciphering its role as a new viral reservoir and as a new mode of viral spread. The~     prospective national study will be conducted on cells isolated from blood samples from 20~     patients infected with HIV.~   "
128266|NCT01888484|"~     This is an open-label phase III study with a 12-week wash-in/wash-out period followed by a~     12-month efficacy period. The main goals of the study are to assess the efficacy of octanorm~     in preventing serious bacterial infections (SBI) compared with historical control data and to~     evaluate the pharmacokinetic (PK) characteristics of octanorm.~   "
127698|NCT01895894|"~     Idiopathic nephrotic syndrome is generally responsive to steroid therapy, but some patients~     need other immunosuppressants to reduce steroid dependency. The long-term use should be~     restricted due to adverse effects of cyclosporine, such as hypertension and nephrotoxicity.~      Mycophenolate mofetil for steroid-dependent nephrotic syndrome has been reported to have~     similar efficacy and fewer undesirable effects to other drugs in mainly observational~     studies. To determine the efficacy of mycophenolate mofetil in the management of~     steroid-dependent nephrotic syndrome, the investigators designed this prospective randomized~     controlled study.~   "
127699|NCT01895881|"~     This study aims to determine if hormone replacement therapy, given during perimenopause may~     prevent the progression of saccular cerebral aneurysms.~   "
127700|NCT01895868|"~     The clinical effects of simulation-based ultrasound training has not yet been explored. To~     examine the long-term effects of training, we plan to conduct a trial, where half of all new~     residents are randomized to simulation-based training and the other half to traditional~     clinical training only. The effects are assessed after two months of practice by evaluating~     two ultrasound scans performed by the residents. These scans are subsequently evaluated by a~     blinded consultant gynecologist and rated using the Objective Structured Assessment of~     Ultrasound Skills, which has been validated in previous studies.~   "
127701|NCT01895855|"~     the purpose of the study is to determine if PXVX0200 is safe and effective in preventing~     cholera infection~   "
127702|NCT01895842|"~     The goal of this clinical research study is to find the highest tolerable dose of ruxolitinib~     that can be given to patients with low or intermediate-1 risk MDS. The safety of this drug~     will also be studied, and whether it can help to control the disease.~   "
127703|NCT01895829|"~     The goal of this clinical research study is to learn if ferumoxytol, when given at the time~     of a magnetic resonance imaging (MRI), can help researchers learn more about the spread of~     certain kinds of cancers.~      Ferumoxytol is designed to deliver iron to treat iron-deficiency anemia (low red blood cell~     counts) in patients with chronic kidney disease. In this study, it will be used as an MRI~     contrast. Contrasts are used by doctors in order to see MRI images more clearly.~   "
127704|NCT01895816|"~     The purpose of this study is to determine whether the effect of mixed herbals drug (citrus,~     citrolus vol, lan, carrot seed, zingiber, onion, basil, cinnamon) administration on male~     infertility: oligospermia~   "
127705|NCT01895803|"~     Discovery of factors affect the decision of the woman to perform or not to perform a Pap~     test.Participate in the study 100 women who smoke. Age range 18-60~   "
127706|NCT01895790|"~     This research is being done to assess the effects of pancreatic duct stenting on relief of~     obstructive pain (pain due to outflow obstruction of main pancreatic duct) caused by~     pancreatic cancer.~   "
127707|NCT01895777|"~     The main objectives of this large phase IIb/III paediatric study are to assess the efficacy~     and safety of dabigatran etexilate relative to standard of care and to document the~     appropriateness of the proposed dabigatran etexilate dosing algorithm for use in patients~     from birth to less than 18 years of age.~   "
127708|NCT01895764|"~     The purpose of this study is to determine if association of methotrexate with adalimumab~     leads to decrease immunogenicity beside adalimumab alone in Ankylosing Spondylitis.~   "
127709|NCT01895751|"~     Background: Most coronary artery bypass grafts (CABG) are diseased or blocked within 10 years~     of surgery meaning CABG survivors have an ever increasing risk of recurrent angina, heart~     attack and death. Given the large number of CABG survivors in the United Kingdom (UK), and~     the complexities of their clinical management, their heart health problems and related~     treatment are an increasing challenge in the UK National Health Service (NHS) and worldwide.~      There is considerable controversy in the NHS and internationally about how to best manage~     patients with prior CABG and unstable angina / non-ST elevation acute coronary syndromes~     (NSTE-ACS). This is because there is no robust evidence to inform treatment practices or~     clinical guidelines since, historically, these patients have been excluded from randomised~     trials. This is the rationale for our study.~      Aims: Our overall aim is to undertake a clinical trial of conservative non-invasive~     management with optimal drug therapy versus routine invasive management in NSTE-ACS patients~     with prior CABG during routine clinical care in NHS hospitals across the UK. Our trial is a~     proof-of-concept study of feasibility, safety, potential efficacy and health economics.~      Hypothesis: A routine invasive approach in NSTE-ACS patients with prior CABG will not be~     superior to a conservative non-invasive approach with optimal medical therapy.~      Design: The pilot study will involve 60 patients recruited in large urban hospitals (Western~     Infirmary, Glasgow Royal Infirmary) and district general hospitals (Royal Alexandra Hospital,~     Royal Blackburn Hospital (RBH)) to reflect usual practice in the UK. One of these hospitals~     (RBH) has an on-site cardiac catheterization laboratory, whereas the other hospitals refer~     patients who have been triaged for invasive management to the regional cardiothoracic centre~     (the Golden Jubilee National Hospital). In this proof of concept study, the investigators aim~     to gather information about screening, recruitment, randomisation, patient characteristics~     (including comorbidity and quality of life) and initial clinical outcomes to inform the~     design of the definitive trial. The follow-up will be in line with standard clinical care~     i.e. 30-42 days and 1 year. The investigators will hold data in the longer term to enable~     long-term follow-up analyses. The investigators will record information on NSTE-ACS patients~     with prior CABG who are ineligible to take part or who do not wish to be randomised as part~     of all follow-up registry of 'all-comers'.~   "
127710|NCT01895738|"~     Youth injured by violence is a major public health concern in Canada. It is the fourth cause~     of death and the leading reason for a youth to visit an emergency department (ED). In~     Winnipeg, 20% of youth who visit an emergency department with an injury due to violence have~     a second visit for a subsequent violent injury within the following year. This is consistent~     with studies in other jurisdictions that demonstrate that violent injury is a chronic~     condition. Youth injured by violence are in a reflective and receptive state of mind,~     rendering the emergency department setting appropriate for intervention. The investigators~     propose a WrapAround Care model delivered by a support worker with lived experience with~     violence, supported by a social worker, an addictions and mental health counsellor, a family~     counsellor and links to multiple community partners. Support workers will be on call 24 hours~     a day, 7 days a week in order to start the intervention in the ED and take advantage of the~     teachable moment. The proposed study is a pilot randomized control trial to assess the~     feasibility of a randomized control trial designed to assess efficacy. For the pilot trial~     the investigators will assess recruitment, treatment fidelity, participant adherence and~     safety. The intervention arm will receive wraparound care initiated at the time of their~     visit for injury due to violence. The control arm will receive standard of care (usually a~     list of community contacts). The investigators will use an adapted pre-consent randomization~     methodology. This intervention has been developed using a community based participatory~     research approach. Our team includes clinicians, nurses, social workers, community youth~     workers, ex-gang members, elders and researchers.~   "
127711|NCT01895725|"~     The proposed project is a prospective observational, single-center cohort study aimed to~     examine the progression of atherosclerotic alterations of the carotid arteries (IMT, plaque~     volume) during a follow-up of up to four years and to correlate the observed changes with~     traditional and novel biomarkers of atherosclerosis. A total of 600 subsequent patients with~     or established cardiovascular disease or at least one cardiovascular risk will be tested with~     a high-frequency ultrasound probe equipped with automated IMT measurements and 3D~     quantitative plaque volumetry. Plasma samples will be collected and tested for traditional~     and novel cardiovascular risk factors. Both ultrasound examinations and blood sampling will~     be repeated once per year to assess changes in these parameters over time depending on~     treatment modalities, which are left to the discretion of the treating physicians. The~     primary endpoint of the planned study will be the correlation between P-selectin and the~     progression of atherosclerosis as measured by plaque volume and IMT in the carotid and~     femoral arteries, respectively. Secondary endpoints will include the correlation of~     established (hypertension, smoking, diabetes, dyslipidemia) and novel risk factors (hsCRP,~     P-selectin, cholesteryl ester transfer protein (CETP), intercellular adhesion molecule-1~     (ICAM-1), CETP TaqIb polymorphism) with the progression of atherosclerosis, the correlation~     of cardiovascular events with the progression of atherosclerosis and the additional~     predictive value of plaque volume and IMT compared to an established risk score (SCORE card).~   "
127712|NCT01895712|"~     BIOTRONIK - SaFety and Performance Registry for a diabetic patient population with the .bimus~     Eluting Orsiro Stent System Within daily clinical practice - III~   "
127713|NCT01895699|"~     Contrast medium is essential for diagnosis of many diseases. However, recent studies showed~     that contrast agents can induce renal injury and is associated with poor long-term clinical~     outcome, especially in diabetes. To date, no data are available on the relationship between~     contrast medium and endothelial function. Endothelial dysfunction is known to precede~     atherosclerosis and is considered a risk marker for future development of cardiovascular~     disease. Therefore, we hypothesized that contrast agents may induce endothelial dysfunction~     in healthy men. In addition, we hypothesized that contrast induced endothelial dysfunction~     via free radicals. Thus, we also test alpha-lipoic acid whether or not protect endothelial~     dysfunction induced by contrast agents.~   "
127714|NCT01895686|"~     The aim of this study is to analyze similarities and evaluate interchangeability of Visante~     and Cirrus OCT (optical coherent tomography)and to compare agreement between gonioscopy and~     the two systems for evaluation of anterior segment parameters.~   "
127715|NCT01895673|"~     The primary objective of this study is to evaluate the ability of PET-MRI and to detect a~     local site recurrence during the first year of follow-up after RFA or MWA of colorectal liver~     metastases (CRLM) as compared with contrast enhanced (ce) CT and PET-CT. Standard reference~     will be clear focal uptake in the rim of the lesion on PET-CT, possibly in combination with~     histology (when available) or clinical follow-up.~      Secondary outcomes are the inter-observer variability, the ability to diagnose new~     intrahepatic lesions and in what way PET-MRI is able to influence future treatment compared~     to PET-CT and ceCT. The patients satisfaction concerning the PET-MRI will be examined with a~     questionnaire.~   "
127716|NCT01895660|"~     What is the CHAMP Study?~      The CHAMP Study is a multisite clinical trial funded by the National Institutes of Health~     that is comparing the efficacy of alternative therapies for young children with unilateral~     spastic cerebral palsy (or hemiparetic cerebral palsy). Children who meet study eligibility~     criteria at one of the three clinical sites (Roanoke, VA; Charlottesville, VA, and Columbus,~     OH) will be invited to enroll, and their parents will be provided all necessary paperwork~     along with informed consent documentation. Assignment to one of the alternative therapy~     conditions will be random. Participation in the study includes assessment of each child prior~     to treatment, close monitoring of the child's progress during treatment, and post-treatment~     evaluation at the end of therapy, as well as, 6 and 12 months later. Parents will have an~     active role in the project, both observing their child during therapy sessions and then~     engaging in home-based activities that allow the child to practice and extend new motor~     skills. There will be no charge for the therapy provided.~      What are the therapies being tested? In the past decade or so, a new form of therapy for~     children with hemiparetic cerebral palsy was developed and has shown to produce positive~     changes in individual children and in small clinical trials (e.g., DeLuca, Echols, Ramey, &~     Taub, 2003; DeLuca, Echols, Law, & Ramey, 2006; Case-Smith, DeLuca, Stevenson, & Ramey,~     2012). The therapy is named Constraint-Induced Movement Therapy (CIMT) and refers to a~     multi-component form of therapy in which the child has the unimpaired or less impaired upper~     extremity constrained (by a cast or a splint) while also receiving active therapy from a~     specially trained therapist who shapes new skills and functional activities with the child's~     more impaired upper extremity. Traditionally, CIMT therapy dosages have been high - often~     lasting many hours per day, 5 days a week, for 4 consecutive weeks. There are important~     clinical and scientific questions that need to be answered about the effects of different~     dosage levels and about different types of constraint on the child's more functional (less~     impaired) arm and hand. This study will be the first that will directly compare different~     amounts of therapy and different types of constraint to evaluate what works best for young~     children. The therapy is very play-like and engaging for children, and no negative effects of~     casting or the high dosages have been detected in previous clinical trials.~      Who is eligible: Children between 2 and 8 years of age with a diagnosis of unilateral spastic~     cerebral palsy or hemiparetic cerebral palsy. Children must be relatively healthy, not~     currently receiving Botox (or other similar medications), and able to understand simple~     communication and instructions. In advance, the treatment will be explained in detail to~     parents and a written protocol available to share with the child's physician and other~     current therapist for review. During the one month of treatment, children will not receive~     other forms of physical or occupational therapy.~   "
127717|NCT01895647|"~     Rationale : Electric muscle stimulation reduced critical-illness related weakness in patients~     with severe sepsis and septic shock. But optimal protocol of the stimulation in unknown.~      Hypothesis: Focal muscle contraction may improved the muscle power and have systemic~     anti-inflammatory via cytokine secretion . The difference of electricity used in upper limb~     or lower limb stimulation may lead to different effect.~      Study design: Stratified randomized parallel control study, comparing Biceps, Quadriceps~     electric muscle stimulation vs. non-stimulation group.~      Participant: adult patients with severe sepsis and acute respiratory failure requiring~     mechanical ventilation.~      Intervention: daily stimulation of bilateral Biceps or Quadriceps by programmed electric~     devices 32 minutes, 5 days/week~      Outcome:~        1. Primary outcome: Ventilator-dependent days~        2. Secondary outcome: change of hand drip muscle~          power/interleukin-1b/interleukin-6/interleukin-8/TNF-alpha~   "
127718|NCT01895634|"~     The main objective of this study is to document that the thrombectomy catheter (Rev-01) is~     effective and safe when used for revascularization in subjects with acute ischemic stroke~     within 8 hours of symptom onset who are ineligible for treatment with IV t-PA, or in whom~     treatment with IV t-PA has been ineffective.~   "
127719|NCT01895621|"~     The postoperative course of the decompression of the median nerve in the carpal tunnel~     syndrome can sometimes be complicated by pain, paresthesias and other unpleasant symptoms, or~     may be characterized by a slow recovery of nerve function. Lipoic acid is considered to be a~     powerful and effective antioxidant with neuroprotective and neurotrophic properties. Dietary~     supplementation with lipoic acid helps reduce the damage to the nervous structure. Its action~     as a dietary supplement may positively modulate and accelerate healing after decompression of~     the median nerve.~      The aim of the study is to explore any possible effects of this molecule in the postoperative~     period after decompression of the median nerve at the wrist.~      Patients will be enrolled with proven carpal tunnel syndrome. By means of randomization,~     patients will be placed into one of two groups:~      Group A: surgical decompression of the median nerve followed by alpha lipoic acid, 800 mg~     daily for 40 days.~      Group B: surgical decompression of the median nerve followed by treatment with placebo~      The primary endpoint of the study will be Nerve conduction velocity at 3 months after surgery~     after 50 days of discontinuing treatment with alpha lipoic acid (TIOBEC) / PLACEBO.~   "
127720|NCT01895608|"~     The first goal of this study is to examine the extent to which the inclusion of dual-task~     practice to standard balance rehabilitation results in greater benefits to dual-task ability.~     The second goal of this study is to examine the extent to which the addition of cognitive~     training following balance rehabilitation results in greater benefits to dual-task ability.~   "
127737|NCT01895387|"~     We determined the effects of dietary intervention (replacement of refined rice with whole~     grains and legumes and a high intake of vegetables) on circulating Lp-PLA2 activity and~     enzyme activity in peripheral blood mononuclear cells (PBMCs) in patients with impaired~     fasting glucose (IFG), impaired glucose tolerance (IGT) or newly-diagnosed type 2 diabetes.~   "
127738|NCT01895374|"~     Bovine amniotic membrane may show better efficacy than hydrocolloid dressing.~   "
127721|NCT01895595|"~     Guided imagery, a mind-body complementary/alternative treatment modality, offers promise to~     reduce stress and promote lifestyle behavior change to reduce diabetes and heart disease risk~     in obese Latino adolescents. The overall purpose of this study was to determine whether~     guided imagery, could reduce diabetes risk in obese Latino adolescents undergoing a lifestyle~     intervention. The specific objectives were: 1) To pilot test a new 12-week lifestyle~     intervention in obese Latino adolescents, in order to determine the effects of the mind-body~     technique of Interactive Guided ImagerySM, over and above those of healthy lifestyle~     education, on eating and physical activity behaviors, stress and stress biomarkers, and~     hormonal markers of diabetes risk; and 2) To explore the way that changes in stress produced~     by the intervention were associated with changes in hormonal markers of diabetes risk,~     particularly insulin resistance. The investigators hypothesized that participants who~     received guided imagery program in addition to the healthy lifestyle education would show~     greater improvements in insulin resistance, physical activity, dietary intake, and stress,~     than those receiving the healthy lifestyle education without the guided imagery. The~     investigators further hypothesized that reductions in stress due to the intervention would be~     associated with improvements in insulin resistance, a major hormonal marker of diabetes risk.~     For this study, obese, Latino adolescents (age 14-17) were randomized to receive either 12~     weekly sessions of the lifestyle education plus guided imagery program, or lifestyle~     education plus a digital storytelling computer program (as a control). Outcome measures were~     assessed before and after the 12-week intervention, comparing the differences between the~     intervention groups behavioral (eating and physical activity behaviors), biological (insulin~     resistance and stress hormones), and psychological (stress) outcomes.~   "
127722|NCT01895582|"~     Background: Diagnosis and screening for latent tuberculosis in old patients is of special~     interest in regards of the morbidity-mortality of this disease in that context.~      TB-infection diagnosis based on immunological memory detection can be impaired with age. New~     blood tests (QFTB-G and T-SPOT.TB) specific for MTB infection have not been evaluated in~     those old patients.The primary endpoint of this study is the evaluation of the IGRAS for~     active TB diagnosis in patients above 75 years old.~   "
127723|NCT01895569|"~     The treatment of type 2 diabetes mellitus often requires the use of one or more hypoglycemic~     agents to reach the adequate glycemic control. The aim of the study is to evaluate the~     effects of a triple therapy with metformin, pioglitazone and sitagliptin on glycemic~     variability compared to metformin monotherapy, and compared to a combination of metformin and~     pioglitazone. To assess glycemic variability a continuous glucose monitoring system will be~     used.~   "
127724|NCT01895556|"~     The purpose of this study is to measure the behavioral effects of learning information about~     male circumcision and HIV risk on sexual behavior and the demand for male circumcision.~   "
127725|NCT01895543|"~     Safety and Tolerability Extension Trial for Patients with Chronic Idiopathic Constipation~     (CIC)~   "
127726|NCT01895530|"~     The investigators would study about impact of the administration of probiotics in the~     intestinal mucosa of patients undergoing resection colic, by evaluating cytokine profile by~     quantitative real time PCR. The investigators believe that patients who use probiotic~     preoperative would provide cytokine profile less inflammatory than those of the control~     group.~   "
127727|NCT01895517|"~     The aim of this study is to assess efficacy of the screening with concurrent liquid-based~     cytology and HPV DNA testing for the primary cervical cancer screening over 7 years.~   "
127728|NCT01895504|"~     Colonoscopy aims to investigate the entire colon by advancing the colonoscope tip from the~     rectum to the cecum, a process called cecal intubation. Cecal intubation may be difficult for~     different reasons, and features of the colonoscope and the use of imaging devices may~     influence the success rate. We want to compare the performance of a new colonoscope with~     novel features including gradual stiffness with that of a colonoscope supplied with a~     magnetic endoscope imaging (MEI) device. The hypothesis is that the performance of the new~     instrument is non-inferior to the MEI system.~   "
127729|NCT01895491|"~     The main objective of this study is to evaluate the safety of VM206RY in subjects with~     expression of HER2 in breast cancer.~   "
127730|NCT01895478|"~     This study examined whether the Pediatric Asthma Control and Communication Instrument for the~     Emergency Department (PACCI-ED), a 12-item questionnaire, can help doctors in the emergency~     department accurately assess a child's asthma control.~      This study involved an intervention with the doctors in the emergency department of an urban~     pediatric hospital. The intervention was done when one of the doctors involved in the study~     treated a child aged 1-17 years for an asthma exacerbation. Parents answered questions on the~     PACCI-ED about their children's asthma. Half of the doctors were allowed to see the PACCI-ED~     results and half were not. The two groups of doctors were compared on their ability to~     correctly identify asthma control categories, whether a child's asthma was worsening or~     improving, whether the family was administering controller medications as often as they~     should, and how much burden the child's asthma was for the family.~   "
127731|NCT01895465|"~     The population of children presenting to the Emergency Department (ED) for treatment~     increases day by day, creating a further burden on the limited nursing staff and where many~     children and their parents are forced to wait many hours until their medical investigation~     ends. Part of the many hours waited are for various tests the patient has to undergo, where~     the urine test is one of the main ones.~      Urinary tract infections in children are a common cause of death due to acute and chronic~     complications alike. Our study aims to test a urine collection method to see whether it~     reduces parents' and/or nursing staff's involvement and thereby reducing the urine sample's~     percentage of contamination.~   "
127732|NCT01895452|"~     This is an extension of a previous study (ALK9072-003EXT). The purpose of this study is to~     continue to evaluate the long-term safety and durability of effect of ALKS 9072 in subjects~     with stable schizophrenia, and to allow subjects who are doing well on ALKS 9072 to continue~     treatment.~   "
127733|NCT01895439|"~     1. Expanding and priming Bone Marrow (BM)- Mesenchymal Stem Cells (MSCs) to a clinical~          scale according to Good Laboratory Practice using xenogenic free media instead of the~          previously used FCS.~        2. Assessing the safety of injecting autologous BM-MSCs to Multiple Sclerosis (MS)patients~          who fail to respond to conventional treatment.~        3. Assessing the therapeutic benefits on the participants in the trial as per established~          methods.~   "
127734|NCT01895426|"~     The purpose of this study is to collect clinical and radiological mid-term (2 years) data on~     the ArcadiusXP L® lumbar stand-alone cage in a post-market clinical follow-up study (PMCF)~     limited to 32 patients.~   "
127735|NCT01895413|"~     This is a non-randomized study aimed to determine the safety and efficacy of intra-articular~     injection of autologous bone marrow-derived mesenchymal stem cells in patients with knee~     articular cartilage defects.~   "
127736|NCT01895400|"~     The purpose of this study is to determine whether Renexin is effective in the treatment of~     vestibular symptoms in patients with recurrent vestibulopathy.~   "
127770|NCT01894958|"~     The purpose of this study is to determine whether NNZ-2566 is safe and well tolerated in the~     treatment of Fragile X Syndrome in adolescent and adult males.~   "
127739|NCT01895361|"~     The purpose of this study is to determine whether the investigational drug SelG1 when given~     to sickle cell disease patients either taking or not taking hydroxyurea is effective in~     preventing or reducing the occurrence of pain crises. SelG1 prevents various cells in the~     bloodstream from sticking together. By stopping these cell-cell interactions, SelG1 may~     prevent small blood vessels from becoming blocked and therefore reduce the occurrence and~     severity of pain crises. Other effects of SelG1 will also be evaluated, as well as the safety~     of the drug and how long it stays in the blood stream.~      Funding Source - FDA Office of Orphan Products Development (OOPD)~   "
127740|NCT01895348|"~     Obstructive sleep apnea is a common disease, associated with cardiovascular disease,~     cerebrovascular disease, and many other medical conditions. Therefore the precise diagnosis~     and treatment are important. With drug-induced sleep endoscopy (DISE), the three-dimensional~     evaluation of upper airway and airway obstruction could be possible. The problem of the DISE~     is that there is the difference between a sedative-induced sleep and normal sleep. Moreover~     there were no standard sedation protocol of DISE. Propofol has short half-life, about 3~     minutes, so the patients could recover quickly from it. In recent years, using target~     controlled infusion(TCI) of propofol, the effective effect-site concentration for DISE could~     be reached easily with hemodynamic stability and minimal toxic effect. In a previous pilot~     study, the endoscopy for the diagnosis of sleep apnea could be done successfully with~     propofol TCI. However there were some desaturation events, although the EEG showed that the~     patient was not in deep sleep enough. Therefore we thought that not only further study of~     propofol for DISE but also the study of other drugs for DISE will be needed to overcome this~     limitation. Dexmedetomidine, the selective α2-adrenoreceptor agonist, has analgesic effect~     and almost no respiratory depression, therefore it could be a good alternative drug for DISE.~     The purpose of this study is designing the appropriate sedation protocol for DISE using~     propofol or dexmedetomidine, and enabling the safer and more accurate DISE.~   "
127741|NCT01895335|"~     Primary Objective:~      To describe efficacy, tolerability and convenience of teriflunomide treatment through the~     evaluation of Participant Reported Outcomes (PROs).~      Secondary Objectives:~      To describe disease progression using PROs. To describe clinical outcomes (ie, treated~     relapses) in teriflunomide treated participant.~      To describe the change in cognition in teriflunomide treated participants. To describe safety~     of teriflunomide in participant treated (based on adverse events reporting).~      To describe adherence and persistence to teriflunomide treatment. To describe quality of~     life, activity and leisure over the period of teriflunomide treatment.~      To compare Participant Determined Disease Steps (PDDS) and Expanded Disability Status Scale~     (EDSS) in assessing Multiple Sclerosis (MS) disease progression.~   "
127742|NCT01895322|"~     To investigate the efficacy, pharmacokinetics, pharmacodynamics, and safety of OPC-41061 in~     patients with chronic renal failure who are undergoing peritoneal dialysis, using daily urine~     volume, body weight, and edematous conditions as parameters and conducting dose escalation~     every 2 days until reaching the dose that achieves urine volume increase and then performing~     5-day repeated administration at the fixed dose, the final dose used in the dose escalation~     period.~   "
127743|NCT01895309|"~     This is a randomized, double-blind, parallel group, multicentre clinical study to evaluate~     the efficacy, safety, pharmacokinetics and immunogenicity of SB4 compared to Enbrel in~     subjects with moderate to severe Rheumatoid Arthritis (RA) despite Methotrexate (MTX)~     therapy. In some countries, after 52 weeks of treatment with either SB4 or Enbrel, subjects~     will be enrolled into an open label extension period. Subjects will receive SB4 for an~     additional 48 weeks.~   "
127744|NCT01895296|"~     Dumping Syndrome consists of (1) a too rapid gastric emptying, (2) an inappropriate release~     of GI hormones (as a reaction to the hyperosmolar contents in the duodenum) and (3) an~     hyperinsulinemic response to a too rapid absorption of glucose. Because it is not well known~     which somatostatin receptor(s) (sst1-5) influence(s) Dumping Syndrome most, the goal of this~     trial is to evaluate :~        -  the effect of pasireotide (sst1, 2, 3, 5 agonist) on the control of gastric emptying.~        -  the effect of pasireotide (sst1, 2, 3, 5 agonist) on the release of GI hormones (during~          OGTT).~        -  the effect of pasireotide (sst1, 2, 3, 5 agonist) on the hyperinsulimic response (during~          OGTT).~        -  the efficacy of pasireotide (sst1, 2, 3, 5 agonist) for control of objective parameters~          of Dumping Syndrome (hematocrit (Hct), pulse rate and occurrence of hypoglycemia after~          an Oral Glucose Tolerance Test (OGTT) with 75g of glucose)~        -  the efficacy of pasireotide (sst1, 2, 3, 5 agonist) for control of overall symptoms as~          measured by the combined Dumping Syndrome score~        -  the efficacy of pasireotide (sst1, 2, 3, 5 agonist) for control of symptoms as measured~          by (a) early and (b) late phase dumping symptom score separately~        -  the efficacy of pasireotide (sst1, 2, 3, 5 agonist) for control of quality of life (QoL~          SF-36)~   "
127745|NCT01895283|"~     Muscular dystrophy is a group of disorders that are characterized by progressive muscle~     weakening and loss of muscle mass, caused by defects in muscle proteins. Muscular dystrophy~     is almost always inherited disorders, and so far, no curative treatments exist.~      Previous studies have shown that endurance training significantly improves fitness and~     self-assessed muscle function in a variety of muscular dystrophies. In this study, we wish to~     investigate whether patients with Bethlem myopathy (a specific form of muscular dystrophy)~     also benefit from endurance training.~      The study consists of two test days, a 10-week training period and five blood tests.~      Patients will be required to train, three times per week, for 10 weeks, on a bike ergometer~     with a specific training intensity, under pulse rate monitoring.~      The training period will be flanked by two test days, where we will determine, and compare~     the patients' muscle strength and fitness level, from before to after the training program.~     The patients conditioning level will be determined from a 15 minute cycle ergometer test and~     patients will undergo three functional tests to determine their functional muscle strength.~      We will as a safety measure analyze blood tests before, during and after the training program~     for the muscle enzyme creatine kinase (an indicator of muscle damage) and through adverse~     effects as reported by patients during weekly telephone-consultations with the Principal~     investigator.~      We anticipate, that Bethlem myopathy patients will have a similar rise in fitness level and~     functional muscle strength, as that seen in patients with other forms of muscular dystrophy,~     who undertake a similar training program.~   "
127746|NCT01895270|"~     This application seeks to address the problem of opioid withdrawal by examining the utility~     of the L-type calcium channel blocker (CCB) isradipine as an adjunct to BUP detoxification.~     This project will address the need for improved detoxification strategies by assessing the~     tolerability and preliminary efficacy of adjunct isradipine during a BUP detoxification in~     opioid-dependent participants. This pilot clinical trial will determine the potential utility~     of the L-type CCB isradipine to improve treatment outcomes in up to 60 opioid-dependent~     individuals undergoing a BUP detoxification procedure. Specifically, this study will~     determine the efficacy of isradipine to reduce withdrawal symptoms, craving, and illicit use~     of opioids in opioid-dependent individuals undergoing BUP detoxification and determine the~     tolerability and safety of controlled-release isradipine (10 mg/day) in opioid-dependent~     individuals undergoing BUP detoxification. Currently, the only FDA-approved medications for~     opioid withdrawal are the opioid agonists methadone and BUP, both of which have abuse~     liability. Our findings, if positive, will support a larger phase II clinical trial.~   "
127747|NCT01895257|"~     The investigators propose to conduct a randomised phase III trial evaluating a maintenance~     strategy comparing hepatic arterial injection of Yttrium-90 resin microspheres plus~     continuing simplified chemotherapy with/without targeted therapy versus continuing simplified~     chemotherapy with/without targeted therapy alone for patient with dominant or exclusive and~     unresectable liver mCRC controlled after 3-6 months of chemotherapy induction.~   "
127748|NCT01895244|"~     Autologous stem cell therapy has been shown to be effective in patients with systemic~     sclerosis. Nevertheless treatment is associated with treatment related mortality and patients~     die during follow up despite successful transplantation.~      Intention of this trial is to improve overall survival by modifying the existing protocol~     used for the ASTIS trial.~      To reduce treatment toxicity we reduce the dose of Cyclophosphamide (CYC) for mobilisation to~     2x1g.~      Especially in patients with cardiac manifestations we also modify the conditioning regimen by~     adding thiotepa and reducing CYC; as CYC has known cardiotoxic side effects.~   "
127749|NCT01895231|"~     The primary purpose of the study is to evaluate the effect of IV iron isomaltoside 1000~     compared with placebo on Hb in first-time female donors with p-ferritin below 30 µg/L~   "
127750|NCT01895218|"~     The primary purpose of this study is to compare the efficacy of IV high single dose infusion~     of iron isomaltoside 1000 to standard medical care in women with PPH evaluated as physical~     fatigue.~   "
127751|NCT01895205|"~     The primary purpose of this study is to get explorative information about IV high single dose~     infusion of iron isomaltoside 1000 compared to RBC transfusion in the treatment of severe~     PP-IDA evaluated as physical fatigue~   "
127752|NCT01895192|"~     A new concept for observing the fine morphology of spermatozoa at high magnification (x6000)~     with an inverted microscope, a numeric camera using differential interference contrast has~     been developed (1). This technique called Motile Sperm Organellar Morphology Examination~     allows to see some abnormalities, mainly vacuoles on the head of spermatozoa. These vacuoles~     appear to be related to sperm DNA damage and to affect embryo developmental potential (2, 3,~     4). The application of Motile Sperm Organellar Morphology Examination may represent an~     improvement in the evaluation of semen quality, with some potential clinical repercussions at~     the diagnostic/prognostic level. First of all, the investigators need data on fertile men in~     order to define  normality  of sperm morphology at high magnification. The aim of this~     study is therefore to better characterize these vacuoles (number, surface, position) in a~     population of men fertile in order to establish normality criteria.~   "
127753|NCT01895179|"~     The purpose of this pilot study is to find out what eating meals in a short time period early~     in the day (time-restricted feeding) versus eating meals spread out during the day (grazing)~     does to the body's ability to control blood sugar and to the health of its blood vessels.~      The investigators hypothesize that time-restricted feeding will be more effective at~     improving glucose tolerance and vascular condition (inflammation and micro- and~     macro-vascular function) than grazing.~   "
127754|NCT01895166|"~     The purpose of this study is to evaluate the efficacy and safety of endobronchial~     ultrasound-guide sheath(EBUS-GS) for the diagnosis of peripheral pulmonary lesions (PPLs)~     without radiographic fluoroscopy.~   "
127755|NCT01895153|"~     The efficacy of pentosan polysulfate sodium, hydrodistension and combination therapy in~     patients with bladder pain syndrome.~   "
127756|NCT01895140|"~     The purpose of this study is to evaluate the clinical and economic impact of implementation~     of renal denervation with the Symplicity™ Catheter System for treatment-resistant~     hypertension in Ontario, Canada.~   "
127757|NCT01895127|"~     This is an open-label analysis that will compare eculizumab versus Plasmapheresis (PP) and~     Immunoglobulin (IVIg) for the treatment of antibody-mediated rejection (AMR) in renal~     transplant recipients. All patients will be evaluated from the time of AMR diagnosis for 12~     months.~   "
127758|NCT01895114|"~     The purpose of this study is to help determine whether cystatin C is a more sensitive~     laboratory measurement for renal function in cirrhotic patients.~   "
127759|NCT01895101|"~     It remains still unclear whether topical tranexamic acid has an added value besides the~     administration of intravenously tranexamic acid. We hypothesize that the addition of topical~     tranexamic acid, besides intravenous administration of tranexamic acid, results in a 25%~     reduction of post-operative blood loss after cardiac surgery.~      The aim of this study is to determine whether the application of topical tranexamic acid~     reduces the 12 hours postoperative blood loss by 25% in patient scheduled for cardiac surgery~     on cardiopulmonary bypass, whereby intravenous tranexamic acid is administrated.~      Just before sternal closure, 250 subjects receives pericardial lavage with 2 gr tranexamic~     acid in 200 ml normothermic saline solution (NaCl 0.9%), 250 subjects receives pericardial~     lavage with 200 ml normothermic saline solution without TA and 250 subjects (control group)~     receives no pericardial lavage. The main study parameter is 12 hours post-operative blood~     loss and is assessed by 12 hours post-operative chest tube production.~   "
127760|NCT01895088|"~     This is a 2 year follow up study to monitor the long term safety of the ACI 7000PDT in~     subjects who are still implanted with the ACI and have successfully completed the~     ACU-P08-020/020A studies.~   "
127780|NCT01894828|"~     The aim of the study was to assess the effect of nutritional supplementation on nutritional~     status and postoperational complications in cancer patients with no clinical signs of~     malnutrition~   "
127761|NCT01895075|"~     Bronchopulmonary dysplasia (BPD) is one of the most important morbidities of preterm infants~     with a high incidence and significant impact on resource utilization and long-term outcome.~     Systemic corticosteroids have been shown to be effective in the prevention of BPD through~     their potent anti-inflammatory effects but there are serious concerns on their potential~     detrimental effects on neurodevelopment of infants. In contrast, inhaled corticosteroids~     administered to ventilated infants are thought to be safer due to their topical effect but~     have not been shown to improve outcomes including BPD. To date, there have been few studies~     evaluating the effect of inhaled corticosteroids administered to non-ventilated infants for~     the prevention of BPD. Hence, we are conducting a double-blind randomized controlled pilot~     trial to examine the impact of inhaled budesonide on non-ventilated infants.~      The study objectives, in a cohort of very preterm infants with signs of early BPD are: 1) to~     evaluate the effect of aerosolized budesonide on 'days on supplemental oxygen', and 2) to~     gain an estimate of the impact on BPD and 3) to assess the safety of the intervention in a~     small cohort of preterm infants.~      This will be a single-center randomized double-blind controlled pilot trial. We will recruit~     a total of 50 infants born at less than 30 weeks gestation who are on continuous positive~     airway pressure (CPAP) with fraction of inspired oxygen ≥25% on day 14 of life or later.~     Inhaled budesonide 1mg (intervention group) or normal saline (placebo) will be administered~     three times a day until the infants do not need CPAP or supplemental oxygen or reach 36+0/7~     weeks corrected gestational age. We will evaluate 'days on supplemental oxygen', BPD,~     re-intubation rates, days on mechanical ventilation and days on CPAP as well as adverse~     outcomes.~      The prevention of BPD would have a significant positive impact on patient quality of life and~     medical resource utilization and costs. The study hypothesis is that inhaled budesonide on~     non-ventilated infants with early signs of BPD will reduce the 'days on supplemental oxygen'~     indicating a positive effect for the prevention of BPD. The result of this pilot study might~     also justify and support to proceed to a large confirmatory study to evaluate an effect of~     the intervention on BPD, in which the estimate of the impact on BPD gained in this pilot~     trial may be used to calculate a sample size.~   "
127762|NCT01895062|"~     The primary goal of this study is to determine the effectiveness and safety of delivering~     continuous negative external pressure (cNEP) to the upper airway as a means of preventing~     episodes of respiratory impairment (RI) such as hypoxemia, apnea and hypoventilation~     associated with the use of intravenous sedation in elective colonoscopy in adult patients.~   "
127763|NCT01895049|"~     The disparity between supply and demand for organs has stimulated the development of~     strategies to increase the availability of kidney grafts. Such strategy involves the use of~     kidneys with expanded donor criteria (EDC). This is a study initiated by the investigator,~     open, prospective, randomized, single center designed to compare the safety and efficacy of~     two immunosuppressive regimens based on thymoglobulin, tacrolimus and everolimus versus~     thymoglobulin, tacrolimus and mycophenolate sodium in renal transplant recipients with donor~     criteria expanded.~   "
127764|NCT01895036|"~     The efficacy of buprenorphine as a long-term agonist treatment has been offset by the~     emergence of intolerable withdrawal phenomena in a subset of individuals on chronic~     maintenance who attempt to discontinue the medication. Efforts are needed to better~     understand these challenges encountered with buprenorphine, as well as to develop~     interventions to facilitate medication discontinuation.~      Emerging evidence suggests that these difficulties may be related to the unique effects of~     buprenorphine on sites other than mu-opioid receptors, such as kappa-opioid receptors.~     Kappa-opioid agonism produces aversive, dysphoric-like effects, and can also increase the~     likelihood of reinstatement to drug use through stress-mediated mechanisms. Some of the~     discomfort observed during drug taper may therefore be due to the attenuation or loss of~     kappa-opioid antagonism afforded by buprenorphine, as well as to rebound kappa-opioid~     activation. Naltrexone represents a promising candidate for extending kappa blockade and~     therefore for facilitating discontinuation attempts. Naltrexone and its active metabolite~     6-Beta-naltrexol are competitive antagonists at the mu and kappa receptors, and to a lesser~     extent at the delta receptor. Naltrexone and buprenorphine have comparable affinity for the~     mu-opioid receptor and thus buprenorphine is displaced by naltrexone more gradually than are~     other opioids with less affinity; a careful titration of naltrexone is less likely,~     therefore, to precipitate severe withdrawal states in individuals coming off buprenorphine,~     and the two have been combined to good effect in other settings.~      The purpose of this study is therefore to investigate the feasibility of naltrexone~     augmentation on discontinuing buprenorphine in eligible patients on long-term maintenance.~   "
127765|NCT01895023|"~     Sevoflurane is frequently used for pediatric anesthesia because it has low pungency and rapid~     onset and offset of action.The reported incidence of emergence agitation (EA) following~     sevoflurane anesthesia varies from 10-80%. Despite its spontaneous resolution, EA is still~     considered as a potentially serious complication because of the risks of self-injury, and~     because of the stress caused to both caregivers and families.~      Dexmedetomidine, an Alpha2-adrenoceptor agonist with sedative, analgesic, and anxiolytic~     actions, has been used in pediatric populations.Several prospective clinical trials in~     children have shown that dexmedetomidine significantly reduces the incidence of EA prior to~     recovery from sevoflurane anesthesia. However, the effect of dexmedetomidine premedication on~     emergence agitation has not been fully evaluated. The purpose of the present study was to~     verify the hypothesis that intranasal premedication with dexmedetomidine is effective in~     reducing emergence agitation after sevoflurane anaesthesia.~   "
127766|NCT01895010|"~     Observation on acupoint electric stimulation combined with tropisetron in preventing and~     treating nausea and vomiting and improving the patient's appetite after TACE for primary or~     metastatic liver cancer patients.~   "
127767|NCT01894997|"~     Deep Vein Thrombosis (DVT) is a life threatening condition and a serious concern among~     hospitalized patients, with death occurring in approximately 6% of cases. It involves the~     formation of a clot where stagnant blood flow occurs, predominantly in the deep veins of the~     legs. Three mechanisms underlie DVT, venous stasis (slowing or stopping of the blood),~     hypercoagulability (increased clotting) and damage to blood vessel endothelium (damage to~     blood vessel wall), collectively known as Virchow's triad.~      Intermittent pneumatic compression (IPC) and neuromuscular electrical stimulation (NMES) have~     been shown to improve lower limb blood flow. However, few studies have directly compared the~     two methods and those that have, have used dated NMES techniques.~      The objective of this study is to compare the two methods in terms of blood flow, in both a~     young and an older population.~   "
127768|NCT01894984|"~     The purpose of this study is to evaluate the long-term treatment efficacy, and safety of~     risperidone long-acting injection in participants with schizophrenia (psychiatric disorder~     with symptoms of emotional instability, detachment from reality, often with delusions and~     hallucinations, and withdrawal into the self).~   "
127769|NCT01894971|"~     Single-center prospective randomized trial to evaluate the effect of thermal damage of~     Ligasure® to destroy cornual portion of fallopian tube tisse.~      Right of Left side of fallpian tube is randomized and coagulated one more time than other~     side before cut off. The pathologist evaluate the amount of fallopian tube tissue left at~     both cornual portion of cut off specimen.~   "
127771|NCT01894945|"~     This study aims to investigate the value of dual time point PET/CT in lymphoma. Since FDG~     uptake is linked to glucose metabolism, PET imaging is also used to detect suspected sites~     for infectious and inflammatory disorders. In a clinical setting, it is a challenge to~     distinguish between FDG uptake in benign and malignant lesions and this gives rise to a~     considerable quantity of false positive results and decreased positive predictive values.~     Performing FDG-PET imaging sixty minutes after injection is common practice in the staging~     and surveillance of lymphoma but this procedure may not be optimal, especially not in~     settings where benign inflammatory lesions are of clinical concern.~      In an attempt to find an alternative method for this discrimination, dual time point FDG-PET~     was introduced. This technique has shown itself to be a potentially promising method in~     FDG-PET imaging for distinguishing between malignant and benign lesions using SUV values. The~     reason for the different FDG uptake patterns between inflammatory and malignant lesions is~     unclear. Several factors may contribute to this phenomenon on a cellular basis. It has been~     shown that cancer cells exhibit increased numbers of glucose transporter and low level of~     glucose-6-phosphatase. Varying levels between different cancer cell types may explain the~     different FDG uptake curves. Because various cell types exhibit varying rates of FDG uptake~     we believe that kinetic investigation may prove to be of value in understanding different~     types of lymphoma and identifying how to perform precise imaging for staging and~     surveillance.~   "
127772|NCT01894932|"~     Cases of physical and psychological stress problems is the need to prevent the risk of~     depression, primary care model will help to prevent depression. Many scholars have advocated~     for depression treatment not only concern symptom control and relief, prevention of~     recurrence should also be aware. The literature found cases had depression, with cognitive~     strategy bias , may cause recurrence of depression, under the influence of stress. The study~     was to assist the physical and mental disorder patient caused by stress and depression~     patient having cognitive and emotional regulation, and increased adapting Ability by ongoing~     two separate treatment groups ,Mindfulness-based Cognitive Group Therapy and~     psycho-physiological stress regulation Group Therapy. In addition, psychological groups can~     also help regulation daily Trivia stress, study will try to know about how group therapy's~     effects on patient's immune system.Research has three purposes,to validation 2 group model's~     results in assisting psycho-physiological stressed and depression patient, to establish group~     leader training center and prepare groups' standard procedure manuals,and to understand the~     patient's psycho-physical stress reaction on the immune system and fat cell hormone.~   "
127773|NCT01894919|"~     The aim of this extension study is to explore the antibody persistence 24 to 36 months after~     the last dose of vaccine, in infants that received a two or three dose primary series plus a~     booster dose at 11 months of age, of the Novartis meningococcal B vaccine (rMenB + OMV NZ) in~     groups I to III of the parent V72_28 study.~      This study will also explore the antibody persistence 24 to 36 months after two catch-up~     doses of the Novartis meningococcal B vaccine (rMenB + OMV NZ) administered in children (2 to~     10 years old) in group IV of the parent V72_28 study.~   "
127774|NCT01894906|"~     The purpose of this study is to determine the quantity of iron derived from SFP that is~     transferred from the dialysate to patients during a single dialysis session. The effects of~     various conditions which may affect the transfer of iron such as blood and dialysate flow~     rate, changes in bicarbonate delivery, dialyzer membrane type and the effect of reuse will~     also be investigated. The absorption and removal of iron from the blood will also be~     investigated.~   "
127775|NCT01894893|"~     The main objective of this clinical trial is to collect human milk samples from 0 to 4 months~     after delivery in order to characterize human milk components. The secondary objectives of~     this study are:~        1. To assess whether there is a correlation between human milk composition and mothers'~          diet~        2. To assess whether there is a correlation between human milk composition and maternal~          clinical parameters~        3. To assess whether there is a correlation between human milk composition and mother and~          infant clinical parameters~   "
127776|NCT01894880|"~     In the past decades frequency of cesarean section was increasing. Bonding or early~     skin-to-skin contact (SSC) starts ideally straight after birth. After vaginal delivery~     bonding/early SSC is already well-established. After cesarean section this important process~     starts after termination of operation. A Cochran review analyzed randomized studies and shows~     positive effects of early SSC. Possible concerns to adopt bonding in the operating room are~     beside organizational ones (change of established processes) also a different ambiance in the~     operating room (temperature, light, noise). In a prospective randomized trial, early SSC~     after cesarean section should be analyzed.~      Hypothesis~      Mothers, who have the chance to bond immediately after birth in the operating room, have~     lower cortisol, chromogranin A and alpha amylase levels as well as higher oxytocin levels.~     Adaptation of the newborn is within the normal range. Early bonding has a further positive~     effect on breast feeding, maternal pain processing and mental health.~   "
127777|NCT01894867|"~     Several studies have shown in patients magnesium deficiency with liver cirrhosis.~      Patients with liver cirrhosis showed considerably reduced muscle strength and muscle~     magnesium.~      We suggest addition of magnesium to patients with established cirrhosis in order to reduce~     the neuromuscular and neuropsychiatric manifestations of chronic liver disease.~   "
127778|NCT01894854|"~     The aim of this study is to further investigate the clinical and radiological importance of~     design changes in cementless hip prosthesis. The investigators have earlier evaluated the~     classical Furlong HAC total hip prosthesis and a first design change Furlong Active. Now a~     further development, Furlong Evolution, is to be evaluated. This prosthesis, furthermore,~     comes with and without a collar, and the investigators are going to randomize between the~     two. The investigators hypothesize that the new design will be easier to implant and will~     present equal or less migration than the older designs which would imply a favourable outcome~     in the long term. The investigators further hypothesize that the collar play no major part~     for the long term migration and bone remodelling.~   "
127779|NCT01894841|"~     The proposed study seeks to test the efficacy of an intervention to reduce suicide behaviors~     in Veterans. The Veterans Coping Long Term with Active Suicide Program (CLASP-VA) is an~     innovative, telephone-based intervention that combines elements of individual therapy, case~     management, and significant other/family therapy and is designed to be integrated into a VA~     system.~   "
127781|NCT01894815|"~     Major depressive disorder (MDD) is a common psychiatric condition, mostly treated with~     antidepressant drugs, which are limited for issues such as refractoriness and adverse~     effects. In this context, the investigators investigate a non-pharmacological treatment known~     as transcranial direct current stimulation (tDCS). To prove that tDCS is similarly effective~     than antidepressants would have a tremendous impact in clinical psychiatry, since tDCS is~     virtually absent of adverse effects. Its ease of use, portability and low price are also~     interesting characteristics for using in primary and secondary health care. Thus, our aim is~     to compare tDCS against a fully dosed, effective antidepressant. The study will be a~     non-inferiority, randomized, double-blinded, placebo-controlled, three-arm trial comparing~     active tDCS/placebo pill, sham tDCS/escitalopram 20mg/day and sham tDCS/placebo pill. Our~     primary aim is to show that tDCS is not inferior to escitalopram 20mg/day with a~     noninferiority margin of at least 50% of the escitalopram-placebo effect.~   "
127782|NCT01894802|"~     The purpose of this research study is to demonstrate the safety and efficacy of using two CRS~     Arrays (microelectrodes) for long-term recording of brain motor cortex activity and~     microstimulation of brain sensory cortex.~   "
127783|NCT01894789|"~     Ticagrelor is one of 3 anti-platelet medications used in patients with acute coronary~     syndrome (ACS) to prevent further clot formation and further ischemic damage to myocardial~     tissue. Overall benefits of one drug over the other is neutral in this generally unstable~     population. In pre-clinical trials, ticagrelor showed secondary effects, involving the~     release of adenosine to heart muscle where the demand for blood was increased due to a stress~     condition. Blood flow was increased, potentially preventing potential damage.~      This study will compare ticagrelor, currently only approved for use in ACS patients, against~     clopidogrel by measuring the myocardial blood flow(MBF) during stress to validate this~     phenomenon. The effect on blood flow will be measurable by using two specific doses of~     adenosine as the pharmacologic stress and correlating with measurements of blood flow using~     positron emission tomography (PET) nuclear imaging.~      This study hypothesizes that the increase in MBF during intermediate dose adenosine infusion~     will be greater in ticagrelor treated subjects compared to clopidogrel treated subjects~   "
127784|NCT01894776|"~     Healthy volunteers are being recruited for this pharmacokinetics study. The objective is to~     characterize the pharmacokinetic properties of maraviroc alone and when administered with~     rifabutin and to assess rifabutin and 25-O-desacetyl-rifabutin pharmacokinetics compared to~     the literature.~   "
127785|NCT01894763|"~     Esophageal cancer often causes difficulty swallowing (dysphagia) that can be relieved by~     placement of a stent (a flexible, expandable tube that props open the blockage caused by the~     cancer). Stents are effective but can cause complications. Stents come in different~     diameters. The purpose of this study is to learn if stents of different diameters are more or~     less effective for treatment of dysphagia caused by esophageal cancer.~   "
127786|NCT01894750|"~     The purpose of this study is to pilot and feasibility test an innovative cognitive behavioral~     intervention to improve heart failure self-care among community dwelling older adults.The~     primary aim of this study is to test the effect of the intervention on improving heart~     failure self-care, knowledge and Health related quality of life at 1 month and 3 months. We~     will test three hypotheses comparing 60 older adults with heart failure randomly assigned to~     either the intervention or a control group:~      Hypothesis 1. Participants in the intervention group will have significantly improved heart~     failure self-care than control participants.~      Hypothesis 2. Participants in the intervention group will have significantly improved~     knowledge about heart failure and heart failure self-care than control participants.~      Hypothesis 3. Participants in the intervention group will have significantly better Health~     Related Quality of Life than control participants.~      A secondary exploratory aim is to assess and describe implementation feasibility of providing~     a heart failure self-care intervention in a community group setting.~   "
127787|NCT01894737|"~     The primary aim of this study is to determine the effect of creatine supplementation on~     muscle mass loss during short-term immobilisation in healthy, young people.~   "
127788|NCT01894724|"~     This study designed to evaluate the safety and feasibility of the NeuroSave device to rapidly~     reduce brain temperature while maintaining the brain at a lower temperature than the body~     core during cardiac surgery.~   "
127789|NCT01894711|"~     AIM To determine the value of trastuzumab in the early breast cancer setting in the~     Netherlands.~      RESEARCH QUESTIONS / OBJECTIVES~        1. Is adjuvant trastuzumab in daily practice effectively used, that is, how and to whom is~          it given?~        2. Is the introduction of trastuzumab in early breast cancer cost-effective for the~          Netherlands?~      To address the research questions (objectives), the following outcome measures will be~     determined:~      CLINICAL OUTCOME MEASURES~        1. Actual trastuzumab administration as opposed to planned trastuzumab administration~        2. Selection criteria for chemotherapy and trastuzumab in daily practice~        3. Immediate and longterm toxicities due to adjuvant treatment, specifically cardiac~        4. Disease-free, breast cancer specific, and overall survival in relation to trastuzumab~           ECONOMIC OUTCOME MEASURES~        5. Volumes and costs of diagnostic tests and therapies including those for (distant)~          relapse~        6. Cost-effectiveness of trastuzumab in clinical trials versus in real world~   "
127790|NCT01894685|"~     Several studies indicate that mesalazine might have a preventive effect on recurrence of~     adenomas in patients with and without inflammatory bowel disease. As mesalazine has limited~     adverse effects, it is an attractive candidate for chemoprevention. In this study we aim to~     investigate the antineoplastic properties of mesalazine in patients with sporadic colorectal~     adenomas.~   "
127791|NCT01894672|"~     The purpose of this phase II study is to find out if an investigational drug called LGX818~     can stop the melanoma from growing.~   "
127801|NCT01894542|"~     The investigators have previously shown the intact protein from cod filet improves glucose~     regulation and serum lipid profile in overweight adults. A large amount of trimmings from~     various fish species such as cod is thrown away or sold at very low prices for animal feed,~     and analyses of the amino acid composition reveals that this can be a good protein source for~     humans. Two fractions are normally isolated from intact fish meal, i.e. water soluble and~     non-water soluble proteins. In the present study the investigators will compare these~     fractions, by studying their effects on glucose regulation in overweight/obese adults.~   "
127792|NCT01894659|"~     Premature neonates admitted to the neonatal intensive care unit (NICU) require up to several~     hundred procedures during their hospitalization. Many of these are tissue-damaging procedures~     (TDPs) that cause pain. Through our NIH funded research, we made the novel observation that~     exposure to a single TDP can significantly increase ATP utilization and oxidative stress, as~     evidenced by increased plasma levels of hypoxanthine, uric acid and malondialdehyde in~     neonates exposed to TDPs as compared to controls (no TDP). Because neonates are exposed to~     numerous TDPs, it is relevant to explore the energy costs of repeated exposures to painful~     procedures, an important information that is currently not known, as the effect of this~     cumulative metabolic dysfunction could result in potentially treatable or preventable cell~     injury.~      Oral sucrose analgesia is frequently given to relieve procedural pain in neonates on the~     basis of its effect on behavioral and physiological pain scores. However, we found, through~     our prospective, randomized, double blind study funded by NIH, that although oral sucrose~     significantly reduced pain scores, its administration before a single TDP (heel lance)~     significantly increased ATP utilization. This is evidenced by higher plasma concentrations of~     hypoxanthine and uric acid in neonates given sucrose compared to control neonates (no TDP, no~     sucrose) or neonates just given a pacifier. These novel findings raise concern because~     preterm neonates have limited ATP stores and are susceptible to cell injury due to ATP~     depletion. In addition, it raises the relevant concern: If a single dose of oral sucrose can~     alter ATP metabolism, what are the effects of exposure to multiple doses of oral sucrose?~     More importantly, what is the effect of multiple TDPs and/or multiple oral sucrose dosages on~     ATP utilization, oxidative stress and cell injury? This application will also explore the~     effect of 30% oral glucose, another sweet solution currently used to relieve pain, on ATP~     metabolism.~      In this study, we will test the general hypothesis that exposure to multiple TDPs and/or~     multiple doses of oral sucrose analgesia compared to oral glucose or standard care, alter~     biochemical markers of ATP utilization, oxidative stress and cell injury. We will use a~     prospective randomized clinical research design to test this hypothesis during days of life~     3-7 of human premature neonates. Increased ATP utilization will be quantified by~     concentrations of hypoxanthine, xanthine and uric acid measured using HPLC. Oxidative stress~     will be quantified by concentrations of allantoin using gas chromatography/mass spectroscopy,~     and cell injury will be quantified through urinary concentration of intestinal fatty acid~     binding protein, an early marker of enterocyte injury. Data from this application will~     provide insight into the cellular and biochemical effects of repetitive and accumulated TDPs~     and/or multiple doses of oral sucrose. With this knowledge, we will propose and test~     innovative strategies that will not only decrease pain but also will prevent cell injury or~     cell death.~   "
127793|NCT01894646|"~     Currently, only three radiotracers, (2-[18F]FA, 6-[18F]FA and [18F]AZAN), are available for~     studying α4β2-nicotinic acetylcholine receptors (α4β2-nAChR) in human brain using PET~     imaging. A crucial problem for 2-[18F] FA, 6-[18F] FA and ([18F] AZAN is low binding~     potential (BP) in extrathalamic (ET) regions, including hippocampus, cortex and caudate which~     have lower receptor densities than the thalamus. The importance of imaging ET-α4β2-nAChRs~     (ET-nAChR) has emerged from the post-mortem demonstration of altered densities of ET-nAChRs~     (but not thalamic nAChR) in neurodegenerative diseases and schizophrenia. PET imaging of~     ET-nAChR may prove to be useful in both detecting early changes and following functional~     deterioration in neurodegenerative diseases such as Alzheimers disease. Furthermore, PET~     imaging of ET-nAChR may allow investigation and development of new therapies acting on the~     acetylcholine system.~      The imaging drawbacks of the presently available nAChR radioligands have initiated the~     development of radioligands with greater binding potential by several research groups. The~     available pre-clinical data on the investigators' new radioligand [18F](-)-JHU86428~     ([18F]XTRA) suggest that this radioligand is superior to 2-[18F]FA for quantitative PET~     imaging of α4β2-nAChR (Gao, J. Med. Chem, 2008). In baboon PET studies [18F]XTRA exhibits~     200% greater brain uptake, 300% higher BPs and reaches steady-state in approximately 1.5 h in~     cortical regions post-bolus administration versus 6-8 h for 2-[18F]FA. In vitro binding~     assays shows greater binding affinity of XTRA and similar nAChR-subtype selectivity in~     comparison with 2-FA. Both ligands bind selectively with the β2-subtypes that are predominant~     nAChR subtypes in the mammal brain and display little binding affinity at ganglionic~     α3β4-nAChR.~      The current planned human protocol will be conducted to (1) determine brain distribution~     (brain uptake) and test the reproducibility (in test-retest design) of [18F]XTRA brain PET~     scans for validation of the radioligand; (2) generate estimates of the whole body and~     internal organ radiation absorbed doses from exposure to single iv administrations of~     [18F]XTRA in healthy human subjects; and (3) determine brain distribution of [18F]XTRA in~     patients with Alzheimer's disease.~   "
127794|NCT01894633|"~     Background and purposes:Chloroquine (CLQ), an antimalarial drug, has a lysosomatrophic effect~     associate with increase the sensibility of Radiation through leakage of hidroliticenzimes,~     increase of apoptosis, autophagy mediated by lysosomalhidrolases and increase of oxidative~     stress in vitro. In this phase II study we evaluated the efficacy and safety as~     radiosensitizing of the Chloroquine plus concomitant 30 Gray (Gy) of Whole-brain irradiation~     (WBI)in patients with brain metastases (BM) from solid tumors.~   "
127795|NCT01894620|"~     This research is being conducted to study whether rTMS (repetitive Transcranial Magnetic~     Stimulation) could be potentially used as a treatment for Alzheimer's disease. rTMS is a~     technique that stimulates the brain by rapidly switching a magnetic field in a coil placed~     over your head. Prior to rTMS, single pulse TMS will be used to localize the specific brain~     region that we are interested in.~   "
127796|NCT01894607|"~     The goal of this clinical research is to learn how effective an ultrasound contrast agent,~     called DEFINITY, is when used during ultrasound-guided surgery to remove part of one or both~     kidneys.~   "
127797|NCT01894594|"~     The objective of this study is to assess the effect of alkali administration on bicarbonate~     and potassium levels in patients with Sickle Cell Disease (SCD) and depressed serum~     bicarbonate levels. The study is a prospective non-blinded evaluation of tolerability and~     efficacy of alkali repletion with 4 weeks of observation and two sequential 4 week courses of~     escalating oral sodium bicarbonate treatment.~   "
127798|NCT01894581|"~     The United States has the highest prevalence of obesity among all countries surveyed in 2012~     by the Organization for Economic Cooperation and Development. Maternal obesity is linked with~     anovulation, menstrual cycle abnormalities, subfertility, fetal loss, obstetrical~     complications and congenital anomalies. Changes in reproductive hormones and diminished~     oocyte quality have also been demonstrated. A gap of knowledge exists as the mechanisms~     underlying these harmful effects are poorly understood and no specific treatments exist.~      This proposal will test the hypothesis that dietary omega-3 fatty acids (FA) will improve the~     output of hypothalamicpituitary- ovarian axis in obese women. The investigators will perform~     paired assessments before and after supplementation in 10 obese and 10 normal weight women.~     To test the pituitary and hypothalamic output, the investigators will examine the luteinizing~     hormone (LH) and follicle-stimulating hormone (FSH) responsiveness during frequent blood~     sampling. To test the corpus luteum function, the investigators will examine urinary~     reproductive hormones (E1c, estrone conjugates, and pregnanediol glucuronide (Pdg)) over an~     entire menstrual cycle. The investigators ultimate goal is to collect preliminary data for an~     adequately powered randomized control trial.~   "
127799|NCT01894568|"~     The purpose of this study is to compare LY2605541 to insulin glargine in Asian insulin naïve~     participants who have been treated with oral anti hyperglycemia medications. Participants~     will receive 26 weeks of treatment.~   "
127800|NCT01894555|"~     This clinical trial is examining the effect of 4-week aspirin therapy on platelet~     transcriptome in persons at high-risk for myocardial infarction or stroke due to family~     history of early-onset coronary artery disease.~   "
127814|NCT01894373|"~     to determine the therapeutic roles of CIK cells on patients with psoriasis~   "
127827|NCT01894204|"~     Forward-looking troop established(constituted) by the patients having been included in the~     study  PADIS EP , PHRC on 2006 and 2009, randomized checked(controlled), double-blind,~     comparing an anticoagulating treatment(processing) extended by coumadine versus placebo~     during 18 months at patients having had a first episode of EP idiopathique treated(handled)~     initially 6 months by anti-vitamin K.~   "
127802|NCT01894529|"~     Stroke is accompanied by local inflammatory response and systemic immunosuppression.~     Immunosuppression markers are associated with the occurrence of medical complications~     (infections), whereas inflammatory markers are associated with worse functional prognosis.~      This prospective study tries to validate in acute stroke patients the prognostic usefulness~     of a panel of immune biomarkers that have previously been associated with various clinical~     outcomes.~      The identification of beneficial and harmful immune responses in cerebral ischemia will allow~     the prediction of the clinical course of the patients and will be helpful in designing~     immunomodulatory therapeutic strategies for acute stroke.~   "
127803|NCT01894516|"~     -  280 patients suffering from active rheumatoid arthritis who have an inadequate response~          to methotrexate will be evaluated for improvement of disease activity (efficacy) when~          taking GLPG0634 as monotherapy (3 different doses - 50mg, 100mg and 200mg once daily) or~          matching placebo for 24 weeks.~        -  During the course of the study, patients will also be examined for any side effects that~          may occur (safety and tolerability), and the amount of GLPG0634 present in the blood~          (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of~          action-related parameters in the blood (Pharmacodynamics) will be determined. Also, the~          effects of different doses of GLPG0634 administration on subjects' disability, fatigue~          and quality of life will be evaluated.~   "
127804|NCT01894503|"~     The purpose of this study is to assess the safety and performance of the steroid-releasing S8~     Sinus Implant when used in post sinus surgery patients who present with recurrent sinus~     obstruction.~   "
127805|NCT01894490|"~     Curative treatment of upper gastrointestinal tract neoplasms is complex and associated with~     high morbidity and mortality. In general, the patients are already malnourished, and early~     postoperative enteral nutrition is recommended. However, there is no consensus concerning the~     best enteral access route in these cases.~   "
127806|NCT01894477|"~     This randomized phase II trial studies how well treosulfan and fludarabine phosphate, with or~     without total body irradiation before donor stem cell transplant works in treating patients~     with myelodysplastic syndrome or acute myeloid leukemia. Giving chemotherapy, such as~     treosulfan and fludarabine phosphate, and total-body irradiation before a donor stem cell~     transplant helps stop the growth of cancer cells. It may also stop the patient's immune~     system from rejecting the donor's stem cells. The donated stem cells may replace the~     patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor~     effect). Sometimes the transplanted cells from a donor can also make an immune response~     against the body's normal cells. Giving tacrolimus before and mycophenolate mofetil after the~     transplant may stop this from happening.~   "
127807|NCT01894464|"~     The Early Truancy Prevention Project is designed to prevent elementary school truancy through~     teacher-led interventions that are individualized to meet student needs.~   "
127808|NCT01894451|"~     This research study is a pilot study, which tests the ability of an investigational compound~     to be used in humans for further studies. Investigational means that 89Zr-bevacizumab for~     PET/CT imaging is being studied. It also means that the FDA (U.S. Food and Drug~     Administration) has not approved 89Zr-bevacizumab for PET/CT imaging for use in patients,~     including people with your type of cancer.~      89Zr-bevacizumab is a newly developed radiotracer. Radiotracers are compounds or drugs that~     are attached to small amounts of a radioactive substance. The amount of the compound or drug~     in a radiotracer is also very small. Radiotracers are used to make images of processes that~     are happening in the body, but they do not affect how the body works. 89Zr-bevacizumab is~     made up of the drug bevacizumab and the radioactive substance zirconium-89 (89Zr).~     89Zr-bevacizumab is used for an imaging procedure called positron emission~     tomography/computed tomography (PET/CT). This radiotracer has been used in other research~     studies. Information from those other research studies suggests that 89Zr-bevacizumab-PET/CT~     imaging may be able to measure new blood vessel formation to determine where the cancer is in~     your body and if your cancer is being killed by chemotherapy.~   "
127809|NCT01894438|"~     Non-alcoholic fatty liver disease (NAFLD) is considered as the hepatic manifestation of the~     metabolic syndrome. NAFLD is a pathologic condition which involves both hepatic steatosis and~     non alcoholic steatohepatitis (NASH), as the result of fat accumulation in the liver (liver~     fat >5-10% of liver weight), not due to excess alcohol consumption or other causes of~     steatosis.~      At present, no medication or surgical procedure has been approved for treating NAFLD and~     lifestyle modifications remain the cornerstone therapy targeting both at weight reduction for~     overweight subjects and at prevention of overweight for the normal weight individuals. Given~     that a Mediterranean dietary pattern has a beneficial effect both on the prevention and the~     resolution of the metabolic syndrome, the main aim of the present study is to implement and~     evaluate the potential benefits of an intervention based on the Mediterranean lifestyle in a~     sample of patients with NAFLD.~   "
127810|NCT01894425|"~     The main objective of this study is to investigate the association between the presence of~     HPV infection in one or both members of infertile/sub-infertile couples and the outcome of~     pregnancies obtained by assisted reproduction.~      The success of assisted medical procreation is defined as achieving a pregnancy resulting in~     the birth of a living, viable child.~   "
127811|NCT01894412|"~     The purpose of this study is to compare the safety and pharmacokinetic characteristics of~     HD203 liquid with those of etanercept (enbrel) prefilled injection after subcutaneous~     injection~   "
127812|NCT01894399|"~     Study Design~        -  Open, escalating single-dose design.~        -  7 ascending dose cohorts~        -  In each cohorts, subjects will receive a single dose of HM61713.~        -  Main objective of this study is to evaluate the pharmacokinetics of HM61713 tablet.~   "
127813|NCT01894386|"~     This study will evaluate the pharmacokinetics of FF, UMEC and VI administered from one~     inhaler (at two different strengths of UMEC (125 and 62.5microgram [mcg]) and FF/VI~     (ICS/LABA) and UMEC/VI (LAMA/LABA).~      Subjects will receive each of the four treatments once, separated by a wash-out period of~     7-21 days between doses in a four way crossover design. There will be 4 treatment periods in~     total. During each treatment period, subjects will attend the clinical unit on Day -1 for~     standard safety assessments in addition to familiarization with the inhaler. Each subject~     will remain resident in the unit until at least 24 hours after the dose given on Day 1.~     Following completion of all four treatment periods, a follow up visit will take place 7 to 21~     days following the final dose of study medication.~   "
127815|NCT01894360|"~     This will be a randomized, parallel-group, open-label, single-dose study of belimumab in~     healthy subjects to estimate the relative bioavailability, tolerability and safety of a~     single dose of belimumab 200 milligram (mg) when self-administered SC by healthy subjects~     using a prefilled syringe or autoinjector. This study will also assess the usability and~     reliability of the injection devices. A total of approximately 80 subjects (40 per group)~     will be randomly assigned in a 1 to 1 ratio to receive 200 mg belimumab SC as a single 1.0~     milliliter (mL) injection of the liquid formulation (200 mg/mL) on Day 0 via the assigned~     injection device. Subjects will continue to be followed for 70 days after the administration~     of belimumab.~   "
127816|NCT01894347|"~     Multi-Drug resistant pathogens (MDR) are reported worldwide with increasing incidence,~     especially in intensive care settings.~      One of the drugs which are effective against MDRs, is colistin (polymyxin E). This agent has~     been reintroduced in response to the increase of MDR pathogens and might be used more often~     in the future. Data on safety regarding the most important side effects are not sufficiently~     available. l This study evaluates the toxicity in patients who receive aerosolized colistin.~   "
127817|NCT01894334|"~     The morbidity rate of Stanford A type Acute Aortic Dissection（AAD） has been increasing, about~     5-10/100,000* per year. Emergency surgery has been the main treatment for Acute Aortic~     Dissection, however perioperative mortality rate can be as high as 15~30%. Acute lung injury~     (ALI) is one of the main complications that happen during the perioperative period, which by~     itself covers 30%-50% of the overall mortality rate. Both domestic and foreign countries lack~     researches on risk factors, pathogenesis, disease progression and outcome of ALI, which~     happen during the perioperative period of Acute Aortic Dissection patients.~      This topic study follow projects in the preoperative of Acute Aortic Dissection'surgery~        1. hemodynamic changes (aortic dissection resulting in acute aortic regurgitation, cardiac~          tamponade and proximal high blood pressure)~        2. ischemia - reperfusion injury of aortic dissection distal organ~        3. Aortic intima-media exposure cause coagulation / fibrinolytic system function disorder~        4. systemic inflammatory response syndrome; use relevant clinical radiographic parameters,~          indicators of respiratory mechanics (oxygenation index and lung injury index) and~          biochemical indicators.~      To discuss risk factors and possible mechanisms of ADD patients with pre-operative ALI and~     observe their influences on the progress and prognosis of AAD, to explore early intervention~     in the preoperative for possible risk factors and mechanisms and to evaluate their influences~     on the prognosis, to achieve the purpose of reducing AAD perioperative mortality of ALI and~     medical expenses.~   "
127818|NCT01894321|"~     Percutaneous cholecystostomy (PC) is an effective treatment for cholecystitis in surgical~     high risk patients. However, there has been no definite agreement of the additional~     cholecystectomy in these patients. The investigators surveyed the clinical outcomes of the PC~     in surgical high risk patients. And the investigators tried to prove the PC can be~     appropriate and ultimate treatment for acute cholecystitis patients with critical illness~     through this study.~   "
127819|NCT01894308|"~     This study is a continuation of previous studies done in healthy volunteers to prove the~     efficacy of delivering Testosterone, the male hormone, rapidly across intact skin in s series~     of doses from low to high in men with low-to-no natural testosterone production to measure~     their response to the varying doses. The results of this study will inform further studies~     which will be longer in length, as to the starting doses. The study will be conducted in~     London, U.K. at the Advanced Therapies Centre, The London Clinic.~   "
127820|NCT01894295|"~     The aim of this double blind clinical trial study is to investigate whether alphacalcidol~     treatment in obese subjects can affect the resting metabolic rate. Moreover, the~     investigators will evaluate the pathways of Nesfatin-1, Peroxisome proliferator-activated~     receptor gamma (PPARγ) and eroxisome proliferator-activated receptor- coactivator-1 α (PGC1α)~     protein which may lead to change in metabic rate following treatment with either~     alphacalcidol or placebo.~   "
127821|NCT01894282|"~     This pilot study will evaluate the feasibility of having a non-behavioral health provider~     deliver a combination of manual therapy (MT) and cognitive behavioral therapy for pain~     (CBT-p). In addition, we will evaluate differences in outcomes in patients undergoing the~     combined intervention of CBT-p and MT and those undergoing MT alone.~   "
127822|NCT01894269|"~     Although it is commonly accepted that antiviral therapy should be commenced before or during~     hepatocellular carcinoma (HCC) treatment if the patients have high viral loads and elevated~     ALT or total bilirubin values with signs of cirrhosis, the dilemma exists when HBV DNA and~     liver function (such as ALT, AST, TBIL) remains low level. Whether antiviral therapy make~     sense or not in these patients with no signs of hepatitis or high viral replication remains~     unclear, especially for the relatively advanced stage HCC patients receiving TACE. Thus, the~     investigators carried out this prospective control study to compare the survivals for~     patients after TACE between with or without antiviral therapy.~   "
127823|NCT01894256|"~     This is a 2-part study in patients with advanced solid tumours. Part A will investigate the~     PK of olaparib in patients with mild or moderate renal impairment compared to patients with~     normal renal function; Part B will allow eligible study patients continued access to olaparib~     after the PK phase and will provide additional safety data.~   "
127824|NCT01894243|"~     This is a 2-part study in patients with advanced solid tumours. Part A will investigate the~     PK of olaparib in patients with mild or moderate hepatic impairment compared to patients with~     normal hepatic function; Part B will allow patients with mild or moderate hepatic impairment~     or normal hepatic function continued access to olaparib after the PK phase and will provide~     additional safety data.~   "
127825|NCT01894230|"~     The purpose of this study is to examine if using genetics can improve statin adherence in~     patients who should be taking statins but are not because of prior side effects. This study~     will assist physicians/providers in making a personalized health care plan for prevention of~     cardiovascular disease.~   "
127826|NCT01894217|"~     The purpose of this pilot study is to examine if using genetics can improve statin adherence~     in patients who should be taking statins but are not because of prior side effects with~     statins. This study will assist physicians in making a personalized health care plan for~     prevention of cardiovascular disease.~   "
127828|NCT01894191|"~     Interval (missed) cancers and lower than expected mortality reduction of proximal colon~     cancers in the United States and elsewhere after screening colonoscopy drew attention to~     quality indicators. Missed adenomas which are more likely to be in the proximal colon may be~     contributing factors. An independent predictor of the risk of interval cancers is adenoma~     detection rate. In pilot observations, the investigators showed that water exchange enhanced~     adenoma detection in the right colon (cecum to hepatic flexure). This prospective, randomized~     controlled trial will compare water exchange with water immersion and traditional air~     insufflation in patients undergoing colonoscopy. The investigators test the hypothesis that~     compared with air insufflation and water immersion, water exchange produces a significantly~     higher adenoma detection rate in the right colon.~   "
127829|NCT01894178|"~     A recent article examined the use of Parker Flex-Tip tubes to standard ETTs for oral~     fiberoptic intubation and concluded that there was a significant benefit in terms of~     difficulty encountered when using the Parker Flex-Tip. The Parker Flex-Tip tracheal tube has~     a flexible, curved, and tapered tip design different from traditional endotracheal tubes. The~     design allows the tube to lie closely against the fiberoptic scope that is often used to~     facilitate intubation, resulting in a smaller gap between the ETT and the fiberoptic scope.~     This may allow the ETT to clear anatomic obstructions more easily. The patients they examined~     had an average body mass index (BMI) categorized as normal weight. To our knowledge, there~     have not been any studies that have investigated the use of the Parker Flex-Tube for~     fiberoptic intubations in patients categorized as obese by BMI. Our hypothesis is that the~     Parker Flex-Tip ETT results in easier passage of the ETT over a fiberoptic scope during~     elective fiberoptic intubation of obese patients in comparison to a traditional ETT.~   "
127830|NCT01894165|"~     Phase 1 single dose study of ALXN1101 in healthy volunteers.~   "
127831|NCT01894152|"~     Abbott Vascular (AV) obtained marketing approval for the XIENCE PRIME Everolimus Eluting~     Coronary Stent System (XIENCE PRIME EECSS) in China from the China Food and Drug~     Administration (CFDA) on August 10th, 2011.~      This prospective, observational, open-label, multi-center, single-arm, post-approval study is~     designed to evaluate the continued safety and effectiveness of the XIENCE PRIME EECSS in a~     cohort of real-world patients receiving the XIENCE PRIME EECSS during commercial use in~     real-world settings in China.~      This study has no primary outcome measure. All observations are of equal weight.~   "
127832|NCT01894139|"~     The Nutrition Research Unit at Copenhagen University Hospital Herlev will during the fall~     2013 initiate a randomized and controlled intervention study engaging 390 obese pregnant~     women. The overall aim of APPROACH is to investigate how an optimal diet during pregnancy~     influences the programming of the offspring. The children will after birth be included in a~     prospective cohort according to maternal randomization and examined six times from delivery~     until the age of nine years.~   "
127833|NCT01894126|"~     With the increased prevalence of cellular phones, mobile technology provides an important~     tool to reach underserved populations in low to middle income countries. mHealth~     interventions offer promise to improve maternal child health throughout the reproductive~     health continuum if they contribute to increasing skilled birth attendance, family planning~     and exclusive breastfeeding. We propose a randomized clinical trial to determine effect of~     using mobile phones to deliver SMS (one-way) versus an interactive SMS dialogue (two-way) on~     uptake of reproductive and neonatal health services and maternal and infant outcomes~   "
127834|NCT01894113|"~     The use of cryoprobes improves the diagnostic yield in transbronchial biopsies compared to~     forceps biopsies to diagnose an interstitial lung disease~   "
127835|NCT01894100|"~     Limb length inequality is when a person has one leg that is longer than the other. This~     research will look at correcting limb length inequality in adults with knee or hip symptoms.~     This study will examine whether ways of measuring leg length inequality in the clinic are~     valid and reliable, determine whether foot posture (flat foot, normal, and high arch) is~     related to leg length inequality, and determine whether shoe lifts are a helpful treatment~     for leg length inequality and knee/hip symptoms.~   "
127836|NCT01894087|"~     Unintentional poisoning is a developing public health problem in the U.S. Unintentional~     poisoning (or overdose) deaths increased 157% among adults between 1999 and 2008. There~     were ~700,000 emergency department (ED) visits due to overdoses in 2007. Medication-related~     overdoses, particularly prescription opioid overdoses, have accounted for much of this~     increase. There have been parallel increases in sales of opioids (with a 6 fold increase~     between 1997 and 2007), as well as both medical and non-medical use of prescription opioids.~     Prescription opioids are now among the most common of drugs used non-medically in the U.S.~      The specific aims of this project are to: 1) Develop an ED-based tailored brief prescription~     opioid overdose prevention intervention. We will examine therapeutic alliance, perceived~     satisfaction, and perceived utility of the intervention; 2) Examine intervention effects on~     precursors of overdose risk behavioral change immediately post-intervention. We will compare~     intervention and control participants on knowledge, self-efficacy, readiness to change, and~     behavioral intentions regarding overdose risk behavior; and 3) Examine intervention effects~     on overdose risk behaviors six months post-intervention. We will compare intervention and~     control participants on: 1) use of high dose/quantity of opioids; 2) using opioids in~     combinations with certain psychoactive substances (i.e., alcohol, heroin, cocaine, and~     sedatives); and, 3) route of administration.~   "
127837|NCT01894074|"~     This is a study to determine whether a low calorie diet using meal replacement shakes~     compared to current counseling about diet, followed by 3 cycles of clomiphene citrate (if~     needed) will result in: 1) improvements in ability to ovulate and achieve pregnancy either~     spontaneously or during 3 clomiphene citrate cycles 2) greater weight loss with reductions in~     waist and hip circumferences and improvements in hormones that are involved in allowing~     pregnancy to occur and hormones that are involved in metabolism, such as insulin and glucose~     (sugar) 3) improvements in other health conditions such as blood pressure, and emotional and~     physical well-being.~      Women eligible to participate will be between the ages of 18-35 with a BMI (ratio of weight~     in kg divided by height in m2) of ≥ 35≤45 kg/m2 who are seeking help for anovulatory~     infertility including women with a diagnosis of polycystic ovarian syndrome (PCOS).~   "
128267|NCT01888471|"~     The purpose of this study is to evaluate antibody levels against Group B streptococcus in~     mothers and the risk of developing invasive Group B streptococcus disease in newborns of less~     than 6 days age as well as infants of age less than 90 days age.~   "
127838|NCT01894061|"~     NovoTTF-100A is a device and Bevacizumab is a study drug that have both been approved by the~     FDA (Food and Drug Administration) for use as monotherapy in treating glioblastoma~     multiforme. The NovoTTF-l00A is a portable battery operated device which produces TTFields~     within the human body using surface electrodes (transducer arrays). Intermediate frequency~     electric fields (TTFields) stunt the growth of tumor cells.~      The purpose of this study is to determine the efficacy of the combination of Bevacizumab and~     NovoTTF-100A in Bevacizumab naive (meaning have never received bevacizumab before) patients~     with recurrent glioblastoma (GBM) as measured by 6-month progression free survival.~   "
127839|NCT01894048|"~     The mainstay of asthma treatment is with inhaled steroids (commonly called a 'preventer') to~     keep the symptoms of asthma under control. Increasing strengths of steroid inhaler may be~     required in order to gain control of asthma, and this is usually guided both by symptoms and~     simple measurements of lung function such as peak flow.~      The airways (breathing tubes) in the lungs get smaller the further into the lungs they go.~     Most simple measurements of lung function only reflect the larger 'central' airways and don't~     provide information on the smaller 'peripheral' airways.Newer measurements have been~     developed that can now give us accurate information on how the smaller airways are~     working.Indeed the small airways seem to play a significant role in asthma in terms of~     inflammation and airway narrowing.~      Recently, new types of steroid inhalers have been developed that have a much smaller particle~     size than other standard inhaled steroids.These have been shown to go deeper into the lungs,~     thus getting into the smaller airways. There have been a few studies suggesting that this~     might improve asthma control. However, we do not know if when small airway function is shown~     to be abnormal, whether this improves with extra-fine particle inhaled steroids, nor whether~     by improving small airway function specifically this translates into improved asthma control.~      In this study we wish to study asthmatic patients who are not completely controlled on~     standard particle size inhaled steroids, in addition to having evidence of abnormal small~     airway function. By doing this we want to find out whether changing to the same dose of an~     extra-fine particle inhaled steroid instead will improve asthma control by getting deeper~     into the lungs and improving small airway function.~   "
127840|NCT01894035|"~     This pilot, non-interventional, company-sponsored, multi-center study documents observational~     data on patients under routine treatment of Pulmonary Arterial Hypertension (PAH) with~     inhaled iloprost (using I-Neb device for the inhalation).~      The planned study recruitment time is 18 months. The maximum follow up period in this study~     will be 12 months.~      The data will be collected from patients who have initiated the treatment mentioned above~     (inhaled iloprost using I-Neb device) since February 1st, 2013.~      Frequency of visits and procedures will be performed under routine conditions. The primary~     objective of this study is to assess the compliance of patients with WHO/NYHA (World Health~     Organization/New York Heart Association) functional Class III Pulmonary Arterial Hypertension~     treated with Inhaled Iloprost in clinical practice, using the I-neb Insight tool.~   "
127841|NCT01894022|"~     This is an open label, long term extension to Study AMB115811. All subjects may remain in the~     extension study for a minimum of 18 months. Beyond the 18-month period, subjects may continue~     in the extension study until one of the following: the product is approved locally for use in~     inoperable CTEPH patients; development for use in the CTEPH population is discontinued or~     product is not approved by the local regulatory authorities; or the investigator decides to~     discontinue the subject or subject decides to discontinue from the study. The primary purpose~     of this study is to provide clinically relevant information on the long term safety of~     ambrisentan in subjects with inoperable CTEPH.~   "
127842|NCT01894009|"~     Background: Asymmetrical foot posture influences the pelvic girdle stability and might give~     pain in the pelvic region. The objective was to investigate if foot manipulation to correct~     foot asymmetry can relieve pregnancy related pelvic girdle pain (PPGP) and shorten sick leave~     periods.~      Design: Randomized single blinded (patients and evaluators) clinical trial comparing foot~     with sham manipulation at 6 weekly treatment sessions.~      Setting: Five physiotherapy out-patient clinics (10 physiotherapists) in Skaraborg Primary~     Care, Sweden.~   "
127843|NCT01893996|"~     Rheumatoid arthritis patients are at increased risk of cardiovascular disease because of~     systemic inflammation that can persist even in patients with well-controlled joint disease.~     We hypothesize that adding an anti-tumor necrosis factor medication, adalimumab, to standard~     non-biologic therapy for rheumatoid arthritis will improve endothelial function (reduce~     cardiovascular risk) in these patients. The design of the trial is as follows: 18 month~     prospective, randomized, double-blind crossover trial comparing the addition of adalimumab to~     the addition of placebo. The primary endpoint is a change in endothelial cell function, as~     detected by brachial artery FMD, at 6 months of adalimumab treatment compared to 6 months of~     placebo.~   "
127844|NCT01893983|"~     The purpose of this study is to investigate health problems among rural Veterans. The~     research project also aims to test a new telephone-based approach for helping Veterans who~     need treatment connect with the appropriate care. This study will help us to better~     understand the kinds of problems Veterans experience. The study will also help us to find~     better ways to help Veterans get the help they may need.~   "
127875|NCT01893580|"~     Background: Improved surgical techniques combined with effective adjuvant chemotherapy, has~     led to a better survival in individuals with NSCLC. The treatment of NSCLC and other cancer~     diseases are after all still complex and potentially lethal.~      Study aim: The rationale for the study PROLUCA is to identify the optimal timing of exercise~     to improve recovery after surgery in patients operated for lunge cancer with focus on~     physical capacity and quality of life.~      Who can participate? Patients above 18 years and diagnosed with lung cancer and referred for~     operation. Participation in this study is not possible if the participants by a doctor are~     advised not to do strenuous exercise.~      What does the study involve? The intervention consists of a combination of (1) exercise~     before surgery and (2) exercise after surgery for lung cancer.~        1. Exercise before surgery is a home-based exercise program is individually designed and~          must be performed for at least 30 minutes every day until surgery. The home-based~          exercise program varies in length due to number of days until surgery, and the intention~          is not exceed 14 days.~        2. The exercise initiated two weeks and 6 weeks after surgery consists of a 12 weeks~          rehabilitation program and three individual counseling sessions. Special needs in terms~          of smoking cessation, nutritional counseling or patient education, this is also offered.~          The exercise consists of individually prepared supervised strength - and fitness~          exercise in a team, two sessions of 60 minutes/week.~      What interventions will be compared? A home-based post-operative exercise program, combined~     with exercise initiated two weeks after surgery, will be compared with usual care (exercise~     initiated six weeks after surgery).~      Will all participants receive the same treatment?~      By draw it is decided which of the 4 groups the participants will attend to in the study:~        -  Group 1: Home-based exercise before surgery and rehabilitation initiated as early as two~          weeks after surgery~        -  Group 2: Home-based exercise before surgery and rehabilitation initiated six weeks after~          surgery~        -  Group 3: Rehabilitation initiated as early as two weeks after surgery~        -  Group 4: Rehabilitation initiated six weeks after surgery (Usual practice as control~          group) What are the possible benefits and risks of participating? There are no risks or~          side- effects of participating other than muscle soreness and exercise is beneficial~          when it comes to recover from an operation from lung cancer.~   "
127845|NCT01893970|"~     Mild traumatic brain injury (mTBI) is a prevalent and costly public health problem with~     disabling consequences. More than one million civilians with mTBI are treated in US hospitals~     and emergency departments each year (Faul, et al., 2010). While the exact number is debated,~     approximately 10-15% of individuals with mTBI will experience prolonged and disabling~     post-concussive symptoms (Stranjalis, et al., 2008; Ruff and Weyer Jamora, 2009), and 34%~     will experience a psychiatric illness in the first year after injury (Fann, et al., 2004). In~     addition, at least 188,270 military service members sustained a TBI from 2000 to mid August~     2010, and nearly 77% of these injuries were mild (Defense and Veterans Brain Injury Center,~     2010). Many individuals require treatment for resulting mTBI symptoms.~      The proposed study builds on preliminary research conducted by the investigators to develop~     and test the effectiveness of a social work delivered education and reassurance intervention~     for adults with mTBI (SWIFT-Acute) against usual care. The proposed study will assess~     acceptability and obtain preliminary effectiveness data for an enhanced social work~     assessment and intervention for adults with mTBI (SWIFT) discharged from the Emergency~     Department (ED). SWIFT includes early education, reassurance, coping strategies, resources~     and a brief alcohol use intervention in the ED plus follow up telephone counseling, needs~     assessment and case management referral to necessary services. The intervention targets~     cognitive, physical, psychiatric and functional outcomes; specifically, post-concussive~     symptoms, depression, anxiety, posttraumatic stress disorder, alcohol use, community~     functioning and successful linkage to community resources.~      It is hypothesized that SWIFT will be acceptable to patients and that participants in the~     SWIFT group will report superior outcomes on measures of post-concussive symptoms, depression~     and anxiety, alcohol use and community functioning and will report increased successful~     linkages to needed resources when compared to the SWIFT-Acute group.~      The specific aims of the study are:~        1. Implement an innovative social work intervention for adults with mTBI (SWIFT).~        2. Assess acceptability of SWIFT using qualitative interviews with participants.~        3. Assess preliminary effectiveness of SWIFT compared to SWIFT-Acute alone on reduction or~          prevention of post-concussive symptoms, depression, anxiety, posttraumatic stress~          disorder (PTSD) symptoms, and alcohol use, and on improvement of community functioning~          and successful linkage to community resources. 80 participants will be randomized to~          receive SWIFT or SWIFT-Acute. Preliminary intervention effectiveness will be assessed~          using standard measures of post-concussive symptoms, the primary outcome, depression,~          anxiety, PTSD, alcohol use, and community functioning. A structured survey will be used~          to assess linkage to community resources.~   "
127846|NCT01893957|"~     The aim of this study is to investigate the influence of electrical stimulation at the speed~     of blood circulation and tactile sensitivity of the arms of women who underwent axillary~     dissection for breast cancer.~   "
127847|NCT01893944|"~     To evaluate the influence of virtual reality and vibrational therapy in reducing pain~     intensity secondary to breast cancer before and after application of treatment protocols,~     through biomedical instrumentation.~   "
127848|NCT01893931|"~     The purpose of this study is to determine whether a phone call from a nurse within 1-3 days~     after discharge from the Emergency Department (ED) decreases return visits to the ED/~     hospital admissions/ death (combined outcome) in patients age 65 and above. As secondary~     outcomes, time to follow up appointment with physician and economic impact of this~     intervention will be assessed.~      Patients 65 years of age and older will be randomized following discharge from the ED into~     one of two groups. Group 1(Intervention) will receive a phone call collecting information~     about understanding of ED discharge instructions and guiding patient through the discharge~     instructions, and Group 2 (Placebo) will receive a follow up phone call for a satisfaction~     survey.~      We hypothesize return visits to the ED and readmission to the hospital will decrease as a~     result of the nurse phone call intervention.~   "
127849|NCT01893918|"~     Cigarette smoking, the major risk factor for Chronic Obstructive Pulmonary Disease (COPD),~     causes systemic effects, such as systemic cellular and humoral inflammation, that could~     substantially contribute to the development of chronic diseases, other than COPD, mainly~     cardiovascular diseases and metabolic disorders. Such chronic comorbidities affect health~     outcomes in COPD, particularly in terms of disease severity and prognosis. The aim of the~     project is to investigate the prevalence of chronic comorbidities associated with COPD and~     their impact on prognosis in elderly patients.~   "
127850|NCT01893905|"~     The main objective is to assess the efficacy of a new formulation containing chondroitin~     sulfate and glucosamine sulfate (CS+GS) compared with placebo in patients with primary~     osteoarthritis of the knee.~   "
127851|NCT01893892|"~     This randomized clinical trial studies levocarnitine in treating patients with~     vismodegib-associated muscle spasms. Levocarnitine may decrease muscle spasms caused by~     vismodegib.~   "
127852|NCT01893879|"~     This randomized clinical trial studies an investigational drug in preventing lymphedema in~     patients at high risk after undergoing axillary lymph node dissection. The study drug may~     prevent lymphedema in patients undergoing axillary lymph node dissection.~   "
127853|NCT01893866|"~     The primary purpose of this study is to evaluate pharmacokinetic comparability of 1x30 mg~     pegvisomant injection administered as a single 1 mL injection versus 2x15 mg/mL pegvisomant~     administered as two separate 1 mL injections and to characterize the pharmacokinetics of the~     new 30 mg strength.~   "
127854|NCT01893853|"~     The purpose of the APEX study is to determine whether carbohydrate-electrolyte beverage~     intake promotes fluid balance during exercise in the heat compared with water or placebo~     intake.~   "
127855|NCT01893840|"~     A study to assess the effect of negative pulsating pressure therapy on patients with impaired~     blood flow to the leg caused by arterial disease, to see if the FlowOx device will increase~     the blood flow to the leg in these patients.~   "
127856|NCT01893827|"~     The proposed study is a pragmatic, randomized, open-label clinical trial of 24 weeks of~     XR-NTX vs. O-NTX using a COMBINE-adapted Medical Management primary care treatment model. 234~     adults >18yo with alcohol dependence will be recruited from the community into treatment in~     public sector primary care settings. The primary outcome which powers this study is a~     dichotomous good clinical outcome defined by abstinence or moderate drinking, and as measured~     by the Timeline Follow-back and analyzed using an intention-to-treat approach among all~     randomized participants. Secondary outcomes include the incremental cost effectiveness of the~     two arms, differences between arms by continuous measures of alcohol intake (drinks/day, %~     days abstinent, time to first heavy drinking day, bio-markers), and the exploratory analysis~     of factors possibly associated with effectiveness, including gender, prior treatment~     abstinence, and mu opioid receptor (OPRM1) genotypes.~      Specific Aim 1: Treatment Effectiveness. To evaluate the effectiveness of extended-release~     naltrexone (XR-NTX) vs. oral naltrexone (O-NTX) in producing a primary good clinical outcome,~     defined as abstinence or moderate drinking (<2 drinks/day, men; <1drink/day,women; and <2~     heavy drinking occasions/month), during the final 20 of 24 weeks of primary care-based~     Medical Management for alcohol dependence. Hypothesis: The rate of this good clinical outcome~     will be approximately twice as great among participants receiving XR-NTX compared with those~     receiving O-NTX.~      Specific Aim 2: Cost Effectiveness. To estimate the incremental cost effectiveness of XR-NTX~     vs. O-NTX,both in conjunction with primary care-based Medical Management. Hypothesis: XR-NTX~     treatment will be more cost effective than O-NTX.~      Specific Aim 3: Patient-Level Predictors of Effectiveness. To identify patient-level~     characteristics associated with effectiveness in both arms.~   "
127857|NCT01893814|"~     To demonstrate benefit and tolerability of a probiotic product in infants with abdominal~     discomfort.~   "
127858|NCT01893801|"~     The primary objective of this study is to determine the efficacy of nab-paclitaxel plus~     cisplatin plus gemcitabine for patients with metastatic pancreatic ductal adenocarcinoma~     (PDA).~   "
127859|NCT01893788|"~     The primary objective of this study is to determine which treatment will be more effective to~     reduce left ventricular mass in hypertensive patients with left ventricular hypertrophy~     comparing aliskiren and eplerenone.~   "
127860|NCT01893775|"~     Background:~      - Celiac disease is a condition where the immune system attacks the cells of the small~     intestine. The intestine becomes inflamed and cannot digest food properly. The disease most~     often causes a reaction to foods that contain gluten. Most people can treat celiac disease~     with a gluten-free diet. However, some people have digestion problems even on a gluten-free~     diet. Researchers want to try a new antibody therapy for celiac disease. The treatment may~     block the immune reaction that causes the disease. They will test this antibody in people who~     have celiac disease that has not responded to a gluten-free diet.~      Objectives:~      - To see if antibody therapy is a safe and effective treatment for celiac disease that has~     not responded to standard treatments.~      Eligibility:~      - Individuals at least 18 years of age who have been on a gluten-free diet for 6 to 12 months~     but still have symptoms of celiac disease.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood samples~          will be collected. These samples will help determine if the specific antibody treatment~          is likely to work.~        -  Before the start of the study, participants will have a biopsy of the small intestine.~        -  Participants will receive three doses of the study antibody as injections. These doses~          will be given 3 weeks apart.~        -  Treatment will be monitored with blood tests and heart function tests. Participants will~          also have a second small intestine biopsy within a week after the last dose of the~          antibody.~   "
127861|NCT01893762|"~     Exercise induces innate immune response activation in athletes. The response starts during~     exercise and lasts for approximately 24 hours. This innate immune response shows similarities~     to the innate immune activation observed in, for example, bacterial infection and trauma.~     Immediately after exercise, athletes develop leukocytosis and cytokine production is altered~     towards an inflammatory pattern. However, to gain insight in immune response, a detailed cell~     receptor expression is required. To investigate the physiological innate immune response to~     exercise, we developed a model in rowers.~      Aim: To determine the type and degree of cellular inflammatory response in peripheral blood~     of elite rowing athletes after both anaerobe and aerobe exercise.~      Study design:~      Investigator driven, monocenter observational pilot study.~      Study population: 16 healthy, non-asthmatic, human volunteers, 18-25 year old. All~     competitive rowing athletes.~   "
127862|NCT01893749|"~     The purpose of this randomized multiple-site clinical study is to determine whether a revised~     CATCH-IT (Internet-based depression prevention program) is more effective than a general~     health education Internet intervention (Health Education)on teens ages 13-18 (inclusive). It~     is hypothesized that teens in CATCH-IT will exhibit lower levels of depressed mood and/or~     maintain lower depressive scores over 2 years long-term follow up as compared to teens in~     Health Education group.~   "
127863|NCT01893736|"~     The investigators will conduct an early postpartum professional breastfeeding intervention to~     postpartum women who are intended to breastfeed newborn babies to improve breastfeeding~     outcomes.~   "
127864|NCT01893723|"~     The Physiodoloris (MetroDoloris, Lille, France) monitor, CE marqued, uses the ECG signal in~     order to compute the Analgesia Nociception Index (ANI) which has been shown to measure the~     relative parasympathetic tone, and hence to reflect the analgesia/nociception balance during~     general anesthesia. The primary endpoint of this randomized multicenter study is to measure~     whether there is a benefit to use the ANI in order to adapt remifentanil administration~     during propofol anesthesia for laparoscopic surgery. Primary endpoint : lesser proportion of~     patients presenting with at least one episode of hemodynamic reactivity, hypotension or~     bradycardia in the ANI guided group vs control group ?~   "
127865|NCT01893710|"~     Within few years the peritoneal membrane of adult peritoneal dialysis (PD) patients undergoes~     substantial morphological transformation, including progressive fibrosis, vasculopathy and~     neoangiogenesis. Ultrafiltration capacity steadily declines and ultimately results in PD~     failure. In children, peritoneal biopsies demonstrating PD associated alterations have not~     yet been obtained. They, however, should be particularly informative, since secondary tissue~     and vascular pathology related to ageing or diabetes is absent.~      An international, prospective peritoneal membrane biopsy study in children on PD will~     therefore be performed. Biopsies will be obtained at time of PD catheter insertion, on~     occasion of intercurrent abdominal surgery (e.g. hernia repair, catheter exchange) and at~     time of renal transplantation. Quantitative histomorphometry and tissue protein expression~     analyses will be correlated with time integrated PD treatment modalities and functional~     characteristics as well as inflammatory and cardiovascular comorbidity surrogate parameter.~     Blood will be obtained during clinical routine sampling. Biopsies will be obtained during~     clinically indicated operations, without substantially increasing operation time and~     associated surgical risks. The detailed histomorphometry of the PD membrane will give~     additional information, potentially impacting on the individual PD regime.~   "
127866|NCT01893697|"~     FRI could give the opportunity to investigate the possible effect of a lateral posture on~     airway diameter and airflow distributions. This physiological study in healthy subjects may~     help to identify the role of positioning as an aid in airway clearance techniques for~     patients with respiratory diseases.~   "
127876|NCT01893567|"~     The aim of this study is to investigate the utility of a technological based rating scale for~     assessing improvement in plaque psoriasis with Clobex spray treatment.~   "
127877|NCT01893554|"~     Human respiratory syncytial virus (RSV) is a common cause of respiratory illness in infants~     and children around the world. This study will evaluate the safety and immune response to a~     RSV vaccine in three groups of participants: healthy children who have already had an RSV~     infection (RSV seropositive), healthy infants and children who have not already had an RSV~     infection (RSV seronegative), and healthy younger infants who have not been screened for~     prior RSV infection.~   "
127878|NCT01893541|"~     This prospective randomized controlled trial will compare endoscopic band ligation (EBL) with~     propranolol and EBL alone in primary prophylaxis of variceal bleeding among cirrhotic~     patients with high-risk varices.~   "
127879|NCT01893528|"~     This is a phase 1, randomized, double-blind, placebo-controlled first-in-human (FIH) study to~     assess the safety and tolerability of ascending single doses of REGN2009 administered to~     healthy volunteers.~   "
127880|NCT01893515|"~     The objectives of this study is~        -  To evaluate the efficacy of PRC-4016 by assessment of the percentage change in blood~          lipids and lipoprotein parameters from baseline after 12 weeks of treatment.~        -  To evaluate the safety of PRC-4016 as assessed by adverse events and other safety~          parameters~   "
127867|NCT01893684|"~     The prevalence of obesity continues to increase at an alarming rate for all sectors of the~     population in the US. Obesity in the older adult cohort is of great concern as it is~     associated with reductions in mobility, declines in physical performance and increased risk~     for physical disability. With regard to body composition, a) fat mass has been determined to~     be a stronger predictor of mobility limitations than low muscle mass in older individuals and~     alternatively, b) leg lean mass has also been cited as a primary determinant of lower~     extremity physical function.~      Obesity is related to increased levels of fatigue and lack of motivation and mental energy.~     Fatigue can be categorized as both a subjective perception and a performance decrement.~     Fatigue can be defined as a perceived lack of physical or mental energy while fatigability is~     another construct categorized by the degree of fatigue associated with activity in any~     dimension (i.e. physical, mental, emotional, and/or social).~      The impact of a higher protein diet on muscle quality, muscle fatigability, perceptions of~     fatigue and systemic inflammation in older adults has not been well documented. The utility~     of a higher protein weight loss diet combined with resistance exercise training to augment~     fat mass loss, attenuate lean mass loss and improve muscle quality and physical function~     could potentially be of high value to overweight older women. The potential further benefits~     of this regimen to enhance mental energy and other aspects of psycho-social well-being are~     unknown.~      The aims of the present study include assessing the effects of the proposed diet and exercise~     intervention on 1) body composition, 2) strength and muscle quality, and 3) energy and~     fatigue symptoms.~   "
127868|NCT01893671|"~     The primary goal of the study is to determine if Optical Coherence Tomography (OCT)~     measurement of corneal power and astigmatism is more accurate than conventional Placido-ring~     corneal topography. A second goal is to evaluate OCT-based epithelial thickness mapping. The~     postoperative epithelial thickness variation will be used to calculate refractive effects and~     calibrate the smoothing parameter in the mathematical model relating corneal mean curvature~     and epithelial thickness. A third goal is to assess the repeatability of OCT measurements. A~     fourth goal is to develop a method of estimating the focusing power, astigmatism, and HOA of~     the crystalline lens based on measurements of the lens' anterior and posterior capsular~     topographies and positions with the ultrahigh-speed MIT OCT prototype.~   "
127869|NCT01893658|"~     The investigators goal is to evaluate the role of XOLAIR® in treatment of Acute~     Tubulointerstitial Nephritis (AIN) with the goal of shortening the duration and dose of~     prednisone for treatment of drug-induced AIN. Currently there is no good treatment for~     drug-induced AIN. Prednisone is the standard treatment but is associated with many~     side-effects when used long-term and at high doses.~   "
127870|NCT01893645|"~     The measurement of blood hemoglobin (Hb) concentration is a routine procedure in pregnant~     women. The assessment of Hb involves several steps, including a needle stick, blood~     collection, blood sample analysis in the laboratory, and waiting for the results.~      Pronto-7 (manufactured by Masimo, CA, USA) is a new portable device that allows a quick~     bedside Hb spot check. A finger clip probe, similar to the standard oxygen finger clip probe,~     provides hemoglobin values in less than 60 seconds.~      In this prospective observational study the investigators will assess the clinical accuracy~     of Pronto-7 derived Hb values compared to the gold standard laboratory Hb values in obstetric~     patients. We will be calculating the mean difference between Pronto-7 and laboratory Hb~     values. We plan to recruit 55 pregnant women admitted for vaginal or cesarean delivery at BC~     Women's Hospital.~   "
127871|NCT01893632|"~     Benzodiazepine dependence is a growing public health problem for which very few~     evidenced-based treatment approaches are available. Approximately 683,000 individuals met~     past year criteria for sedative-hypnotic use disorders in the US during 2010, a prevalence~     greater than heroin or methamphetamine dependence. The most commonly prescribed~     sedative-hypnotic agents are the benzodiazepines. Chronic use induces pharmacodynamic~     tolerance in the GABA neurotransmitter system and individuals with physiological dependence~     find benzodiazepines difficult to discontinue because of withdrawal or rebound symptoms,~     which include autonomic arousal, depression, anxiety, and insomnia. Available evidence-based~     treatment approaches have been primarily directed at therapeutic users of benzodiazepines who~     do not meet criteria for a substance use disorder, with a general consensus that the gradual~     taper of benzodiazepines over a period of several months is the optimal approach. However,~     patients with benzodiazepine dependence are typically referred for inpatient detoxification~     treatment, which rapidly tapers patients off benzodiazepines. Protracted withdrawal symptoms~     frequently persist after discharge, predisposing patients to relapse. More effective~     pharmacotherapeutic strategies are needed for the treatment of benzodiazepine dependence in~     the outpatient setting.~   "
127872|NCT01893619|"~     Observational study regarding the use of supplements in chronic fatigue syndrome patients~   "
127873|NCT01893606|"~     This study is a withdrawal randomized clinical trail to evaluate the clinical efficacy and~     safety of 1.1 chemical drugs N-acetyl glucosamine on Chinese IBS-D patients coming from four~     centers in chongqing. 180 IBS-D patients in this research are accord with the Rome III~     diagnostic criteria, screening/import period pain intensity scores of the NRS week mean value~     are 3.0 plus and the days which at least more than one time a stool type are 6 or 7 type over~     2 days/week. Test cycle includes screening/import period (2 weeks), open treatment period (8~     weeks), a double-blind placebo-controlled randomized withdrawal period (8 weeks), the main~     outcome measures are pain intensity (NRS score 11 point scale) and stool type ( Bristol~     type). And secondary endpoints included overall symptoms sensory scores, defecation~     frequency, abdominal distension, mucous stool and quality of life parameters (IBS-36 scale).~     After the end of the treatment period, the participants whose pain intensity and stool type~     are effective subjects into a randomized withdrawal period, analysis and comparison of the~     difference between treatment group and placebo group withdrawal rate and curative effect~     index score reduces.~   "
127874|NCT01893593|"~     This is a cluster randomized trial of pediatric cardiovascular risk reduction guideline~     implementation in 32 clinical practices~   "
127910|NCT01893125|"~     To investigate the effect of repeat oral dosing of CNV2197944 75 mg tid on the pain~     experienced in diabetic peripheral neuropathy (DPN) as measured by changes in PI-NRS after~     three weeks of treatment compared to the baseline period.~   "
139492|NCT01741493|"~     This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose~     study in healthy volunteers, multiple dose study in patients with rheumatoid arthritis and~     multiple dose study in healthy volunteers.~   "
127881|NCT01893502|"~     Smoking cessation improves mortality, even in patients with existing smoking-related~     morbidity. Telephone follow-up after smoking cessation counselling as been shown to be an~     important method to provide support to smokers and to improve quit rates, especially if three~     or more calls were used in addition to face-to-face counselling. While it is reasonable to~     assume that more counselling leads to better smoking cessation outcomes, little evidence~     exists over the amount of telephone follow-up counselling that is required for optimal and~     sustained abstinence. We aim to investigate if six-months of weekly telephone follow-up is~     superior to one-month of weekly telephone follow-up.~   "
127882|NCT01893489|"~     Until now, no specific atherosclerosis-targeting agent labeled with positron emitter is not~     yet available. Investigators developed neomannosyl human serum albumin(MSA) for the terminal~     mannose residues of MSA binding with the mannose receptors of macrophages in atherosclerosis,~     and investigators investigate whether 68Ga-MSA can be a novel agent for non-invasive~     molecular imaging of carotid atherosclerotic lesion in PET.~   "
127883|NCT01893476|"~     Background: Chronic Obstructive Pulmonary Disease (COPD) remains a major health problem,~     which is strongly related to smoking. Despite publication of guidelines on the prevention and~     treatment of COPD, not all COPD patients receive the best available healthcare. Investigators~     developed a tailored implementation strategy for improving primary care physicians' adherence~     to COPD management guidelines. The primary aim of the presented trial is to evaluate the~     effects of this strategy on physician's performance. The secondary aim is to examine the~     validity of the tailoring of implementation interventions.~      Primary Trial Hypothesis: To study if the rate of adherence to the COPD guideline over a 1~     year will increase among participants assigned to the intervention group in comparison to~     those assigned to the control group?~      Methods/Design: A two-arm pragmatic cluster randomized trial is planned. A total of 540~     patients with diagnosed COPD will be included from 18 general practices in Poland. A tailored~     implementation program will be offered to general practitioners. Participating physicians in~     the intervention practices (n=18) will receive training to provide brief anti-smoking~     counselling. An additional form containing COPD severity scale will be inserted into~     patient's medical records. The checklist with key information about the disease and its~     management while consulting a patient with COPD will be provided to practitioners.~     Investigators will provide practices with training inhaler devices for general practitioners~     (GPs) to teach patients in correct use of each device and to note this education/training in~     patient's medical records. The control practices will provide usual care.~      Discussion: The results of this trial will be directly applicable to primary care in Poland~     and add to the growing body of evidence on interventions to improve chronic illness care.~   "
127884|NCT01893463|"~     Early and effective control of severe bleeding is critical to survival of trauma patients.~     The iTClamp™50 is a Health Canada approved medical device for temporary wound/skin closure~     that quickly controls bleeding by sealing the skin. Similar to a clip, the device seals the~     skin edges within a pressure bar, enabling the creation of a hematoma where blood collects~     under pressure to form a stable clot until definitive repair. The iTClamp50 is indicated for~     use as a skin closure device for short-term soft tissue approximation, including use in~     trauma wounds, lacerations, junctional bleeds or surgical incisions. The purpose of this~     prospective clinical study is to evaluate the effectiveness and safety of the iTClamp50 in~     the ambulance (pre-hospital) and emergency department setting. This will be accomplished by~     observing patients with the device applied from the pre-hospital through to patient~     discharge. The hypothesis is that the iTClamp50 will be safe and effective at providing~     temporary wound closure to control hemorrhage in the pre-hospital and emergency department~     setting.~   "
127885|NCT01893450|"~     Autoimmune ophthalmopathy is clinically evident in one third of Graves' disease cases. In~     most cases it is mild; however, in 3 to 5% of cases it has a severe presentation. At present,~     the treatment is directed to identify vision threatening which requires aggressive~     intervention, usually with glucocorticoids. For mild cases the treatment is limited to the~     normalization of hyperthyroidism and support measures. Preliminary data show that~     pentoxifylline and bromocriptine may have a favorable effect in the course of ophthalmopathy~     by inhibition of the synthesis of TNF-α, VEGF, glycosaminoglycan production, and lymphocyte~     infiltration. Therefore, the aims of this study were to evaluate the effect of bromocriptine~     and pentoxifylline on the clinical course and quality of life of patients with mild to~     moderate ophthalmopathy associated to Graves´disease.~      Methods. Patients with mild to moderate ophthalmopathy, with less than one year of evolution,~     and naive to treatment were randomized to receive treatment during 12 months with either 1)~     bromocriptine (5 mg twice a day) + methimazole (30 mg/day), 2) pentoxifylline (400 mg twice a~     day) + methimazole (30 mg/day), or 3) methimazole only (30 mg/day). They completed 10 visits~     to evaluate proptosis and clinical activity score (CAS). In addition, in the first and last~     visit the quality of life questionnaire specific for Graves' ophthalmopathy(GO-QOL) was~     applied.~   "
127886|NCT01893437|"~     This single-center, randomized, double-blind, placebo-controlled, single dose study will~     investigate the safety, pharmacokinetics, pharmacodynamics of RO6799477 in healthy~     volunteers.~   "
127887|NCT01893424|"~     This project is intended to evaluate self-emulsifying drug delivery system termed~     Piperine-Pro-Nano-Lipospheres (P-PNL) for enhancing the oral bioavailability of~     tetrahydrocannabinol (THC) and cannabidiol (CBD).The oral bioavailability of these~     cannabinoids is hampered by extensive first pass metabolism, resulting in relative~     bioavailability of 6%.~      The main goal of this study is to evaluate the bioequivalence of THC-CBD P-PNL product for~     oral administration to Sativex® buccal spray, as measured by AUC 0-24h, Tmax and Cmax.~   "
127888|NCT01893411|"~     The purpose of this study is to determine whether injections of Botulinum toxin type A into~     muscles of the leg(s) are effective in treating children/adolescents (age 2-17 years) with~     increased muscle tension/uncontrollable muscle stiffness (spasticity) due to cerebral palsy.~   "
127889|NCT01893398|"~     Our previous findings support the notion that group activity program, based on cognitive~     stimulation, recreational-occupational activities and physical-psychomotor exercises, can~     lead to an improvement in behavioral aspects for people with Alzheimer's Disease (AD).~      The purpose of this study is to clarify the efficacy of a rehabilitation program in~     outpatients affected by AD in mild to moderate stages.~   "
127968|NCT01892358|"~     We propose a randomized controlled trial (RCT) of the Skin intervention, compared to an~     assessment-only condition (both groups receive rapid HIV testing, a review of testing~     results, and brief HIV prevention counseling) among 350 injection drug users recruited during~     an acute medical hospitalization at Boston Medical Center. In the general hospital setting,~     injection drug users who otherwise might not seek care are accessible and teachable, and the~     presence of a drug-related illness can set the stage for patients to be more receptive to~     interventions2. We hypothesize that the Skin intervention will produce better outcomes at 1-,~     3-, 6-, 9-, and 12-month(s) post-intervention.~   "
127890|NCT01893385|"~     The main objective is to assess the variation in plasma levels of cathelicidin before and~     after influenza vaccination.~      All bibliographic data suggests that supplementation vitamin D in the elderly often deficient~     in this vitamin may have a double interest:~        -  By induction of cathelicidin, assist in anti-infective response in particular to the~          influenza virus~        -  The normalization of vitamin D status, promote the return to an appropriate immune~          response limiting excess inflammation and improving capacity to respond.~      The entire project will collect new information on the merits of the use of vitamin D in~     aging. A better knowledge of mechanisms involved and the impact of aging on them is a~     necessary prerequisite the definition of a new strategy using this drug in the elderly~     particularly fragile in order to improve its autonomy. This definition seems a sociological~     interest obvious economic knowing the current aging population and its impact future of our~     health system.~   "
127891|NCT01893372|"~     The goal of this clinical research study is to learn if eltrombopag can help to control MDS.~     The safety of this drug will also be studied.~   "
127892|NCT01893359|"~     The objectives of this study are to evaluate the safety and efficacy, with regards to~     regression of refractive outcome, as measured by manifest refraction spherical equivalent~     (MRSE), of two treatment regimens for hyperopic and hyperopic astigmatic subjects: LASIK~     followed by cross-linking performed with the KXL System and Photrexa ZD™ (Riboflavin~     Ophthalmic Solution), as compared to LASIK alone.~   "
127893|NCT01893346|"~     To assess the pharmacokinetics, safety and tolerability of a single dose of CAZ-AVI in~     children from 3 months of age to <18 years.~   "
127894|NCT01893333|"~     To develope nerve sparing radical hysterectomy for treatment of cervical cancer to minimize~     the complication of radical hysterectomy and to maximize quality of life and to evaluate the~     feasibility and efficacy by prospective randomized trial.~   "
127895|NCT01893320|"~     The goal of this clinical research study is to learn if the combination of vosaroxin and~     decitabine can help to control AML or MDS. The safety of these drugs will also be studied.~   "
127896|NCT01893307|"~     The goal of this clinical research study is to compare the side effects of 2 radiation~     treatments for head and neck cancer. The 2 treatments are intensity modulated photon therapy~     (IMRT) and intensity modulated proton therapy (IMPT). Participants will also receive~     chemotherapy along with radiation therapy.~      IMPT is designed to use beams of proton particles to send radiation to the tumor. IMRT is~     designed to use beams of photon therapy to send radiation to the tumor. Both of these types~     of radiation treatment may give a full dose of radiation treatment to the tumor while not~     damaging as much of the healthy tissue around it.~      This is an investigational study. IMRT and IMPT are delivered using FDA-approved and~     commercially available methods. Comparing them is investigational.~      Up to 360 participants will be enrolled in this study. Up to 250 patients will take part at~     MD Anderson.~   "
127897|NCT01893294|"~     This phase I trial studies the side effects and best dose of gemcitabine hydrochloride in~     treating patients with locally advanced pancreatic cancer. Drugs used in chemotherapy, such~     as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing.~   "
127898|NCT01893281|"~     This study will evaluate if testosterone solution can raise testosterone hormone levels into~     the normal range after treatment for up to 9 Weeks, in those participants with a documented~     history of subtherapeutic levels [total testosterone <300 nanograms per deciliter (ng/dL)]~     when previously treated with a topical testosterone gel.~   "
127899|NCT01893268|"~     This prospective, observational study will assess the effectiveness and safety of Avastin~     (bevacizumab) as 1st line therapy in elderly patients with advanced non-squamous non-small~     cell lung cancer in clinical practice. Therapy with Avastin and standard chemotherapy will be~     administered according to the treating physician. Data will be collected for approximately 4~     years.~   "
127900|NCT01893255|"~     This observational study will evaluate the use and efficacy of RoActemra/Actemra~     (tocilizumab) in monotherapy in routine clinical practice in patients with rheumatoid~     arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the~     approved label will be followed for 6 months.~   "
127901|NCT01893242|"~     This randomized, double-blind, placebo-controlled study will evaluate the potential of~     aleglitazar to reduce the risk of end stage renal disease and cardiovascular mortality in~     patients with type 2 diabetes mellitus and chronic kidney disease. Patients will be~     randomized to receive oral daily doses of aleglitazar or matching placebo. The anticipated~     time on study treatment is approximately 3 years.~   "
127902|NCT01893229|"~     Background:~      Bipolar disorder is one of the most common mental illnesses affecting 1%-4% of the~     population, and one of the leading causes of worldwide disability. Mania is a condition of~     excessively elevated mood, characterizes bipolar disorder, and usually is a main cause of~     hospitalization. Mood stabilisers and antipsychotic drugs have long been the maintenance~     treatment of acute mania with and without psychotic symptoms. Though clinical trails have~     been demonstrated that these drugs are individually more effective than placebo in the~     relatively long term (e.g 4, 8 weeks). However, in the pragmatic practice, patient at acute~     mania urgently want to see the effectiveness, and psychiatrist under great pressure and are~     in great need to evaluate the very short-term effectiveness (e.g one week). If the first~     attempted antimanic drug fails, psychiatrist need the evidence that which medication should~     be to added on or switch to.~      Objectives:~      one main aim is to rank the short-term ( e.g.one and two week) effectiveness and~     acceptability of the common anti-mania drugs, including Lithium, Valproate, Oxcarbazepine,~     Quetiapine, Olanzapine, or Ziprasidone. Secondary aim is to investigate which medication to~     add on for non-responders or switch to.~      Methods:~      The study setting: it is expected that 120 subjects with a diagnose of DSM-IV bipolar I~     disorder will be recruited from Guangzhou Psychiatric Hospital, the earliest psychiatric~     hospital in the history of China established by Dr.J. G. Kerr in 1898.~      Design:This study is a randomized, controlled trial. Participants with a Diagnostic and~     Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of bipolar I~     disorder, manic or mixed episode will be randomly assigned to a treatment of Lithium,~     Valproate, Oxcarbazepine, Quetiapine, Olanzapine, or Ziprasidone. In the following~     conditions, participants will take another antimanic drug as a combination medication: 1)~     those who have a reduction in YMRS scores less than 25% after one week of treatment; 2) those~     who have a reduction in YMRS scores less than 50% after two weeks of treatment; or 3) those~     who have a increase in YMRS more than 30% at day 4. An antipsychotic (Quetiapine, Olanzapine,~     and Ziprasidone) will be added on for those who use lithium, Valproate or Oxcarbazepine as a~     first attempted medication; while Lithium, Valproate, or Oxcarbazepine will be added on for~     those who use an antipsychotic as a first attempted medication. Those participants who are~     recognized as non-response/partial response to two combined medications after 6 weeks of~     treatment will switch to Modified Electroconvulsive Therapy (MECT).~      Measures: Primary outcome measures are change scores on the Young Mania Rating Scale (YMRS)~     and dropout rates. Secondary outcome measures include Clinical Global Impressions (CGI)~     Scale, Global Assessment Scale (GAS), Treatment Emergent Symptom Scale (TESS), and Brief~     Psychiatric Rating Scale (BPRS).~      Response criteria: <25% reduction in YMRS scores or >=4 scores of CGI is defined as~     non-response. 25-49% reduction in YMRS scores from baseline as well as <=3 scores of Clinical~     General Impression (CGI) is recognized as partial response.>= 50% reduction in YMRS as well~     as 1 (very much improved) or 2 scores (much improved) of CGI is recognized as response.~     Remission is defined as a YMRS score <=12 and CGI score equal to 1 or 2.~   "
127903|NCT01893216|"~     To investigate the prevalence of psychological symptoms and sexual dysfunction, and to~     estimate their possible interactions in infertile men.~   "
127904|NCT01893203|"~     The aim of the study is to compare the efficacy of two photosensitizers,~     methyl-aminolaevulinate (MAL) and 5-aminolaevulinic nanoemulsion (BF-200 ALA) in the~     treatment of facial actinic keratosis. We use randomized, double-blinded prospective study~     design. The efficacy will be assessed clinically, histopathologically and~     immunohistochemically.~   "
127905|NCT01893190|"~     Phase 1/2a Multicenter, Controlled, Randomized, Open Label, Dose Escalation, Safety,~     Tolerability, and Pharmacokinetic Study Comparing EG-1962 and Nimodipine in Patients with~     Aneurysmal Subarachnoid Hemorrhage~   "
127906|NCT01893177|"~     The study is to assess whether the influenza vaccine Inflexal V for season 2013/2014 fulfills~     the EMA requirements for re-registration of influenza vaccines.~   "
127907|NCT01893164|"~     The purpose of this study is to determine which is the best surgery to treat different~     severity scales of cubital tunnel syndrome.~   "
127908|NCT01893151|"~     The purpose of this study is to evaluate the efficacy of Iguratimod versus placebo on~     synovial inflammation,bone erosion and bone edema as measured by MRI of wrist and~     Metacarpophalangeal joints in patients with early Rheumatoid Arthritis (RA).~   "
127909|NCT01893138|"~     This randomized, double-blind, placebo-controlled, multicenter, confirmatory study will~     evaluate the efficacy and safety of Cook MyoSite Incorporated Autologous Muscle Derived Cells~     for Urinary Sphincter Repair (AMDC-USR) compared to a placebo (vehicle) control dose in the~     treatment of stress urinary incontinence (SUI) in adult female patients.~   "
127911|NCT01893112|"~     African American women account for 66% of HIV infections in women in the U.S., AIDS is a~     leading cause of death for African American women, and African Americans have the lowest~     medication adherence rates compared to other groups in the U.S. One of the reasons for low~     medication adherence among African Americans is fear of stigma. HIV stigma has been linked to~     depression, psychological distress, poor quality of life, poor medication adherence and~     service utilization contributing to morbidity and mortality. Research has found that stigma~     is a moderator to poor adherence via depressive symptoms.~      The current study is a randomized control trial with a time and attention control group to~     test the effectiveness of a stigma reduction intervention adapted for use with African~     American women. A total of 224 African American women will be recruited to participate in the~     study. Half of the women will be from Chicago, Illinois (112) and the other half will be from~     Birmingham, Alabama (112). A workshop will be held once a study site has recruited 28 women,~     half of the women will be in the intervention group (14) and the other half will be in the~     control group (14). Each study site will have 4 cohorts of 28 women.~      The main aims of the current study are:~        1. to determine the long-term effectiveness of the intervention to reduce stigma for~          African American women living with HIV in Chicago Illinois and Birmingham, Alabama~        2. to examine whether stigma reduction due to the intervention is associated with improved~          physical health biomarkers (CD4+ T cell count, viral load), mediated by reduced~          psychological symptoms (depressive symptoms), improved engagement to care, and improved~          medication adherence~        3. to explore whether stigma reduction due to the intervention is moderated by location~          (Chicago vs. Birmingham), transmission risk factor, time since diagnosis, and perceived~          social support~      We expect that the multimedia workshop intervention will demonstrate effectiveness in~     reducing internalized stigma through an easily-disseminated method, and that it will have a~     positive impact on medication adherence and engagement in care for African American women~     living with HIV.~   "
127912|NCT01893099|"~     The best way to combine a loco-regional procedure such as chemoembolisation or~     radioembolization combined with an anti-angiogenic drug is not clear. This phase I trial aims~     to establish, first, the tolerability of the combination of liver radioembolization with~     SirSpheres® and sorafenib in uveal melanoma patients with liver metastasis studying different~     schedules of administration of sorafenib after and before radioembolization. Secondly, we aim~     to evaluate angiogenic markers modifications during these different schedules, either in the~     serum or radiologicaly. Dose of Sorafenib will be 400 mg BID and the timing of introduction~     will differ for one cohort to the other, given after the radioembolization for initials~     cohorts and finally, before and concomitantly to radioembolization for the last cohort.~   "
127913|NCT01893086|"~     Recently, many gynecologic oncologists proposed that surgeons should consider opportunistic~     salpingectomy to prevent ovarian cancer for all patients undergoing hysterectomy for benign~     disease. However, the safety and the consequences regarding ovarian function after~     salpingectomy have not yet to be established. Therefore, the aim of this randomized~     controlled study is compare the ovarian reserve via anti-Müllerian hormone (AMH) between~     laparoscopic hysterectomy (LH) alone and LH combined with salpingectomy.~   "
127914|NCT01893073|"~     The purpose of this study is to determine whether a mindful walking program is effective in~     the treatment of patients with chronic low back pain.~   "
127915|NCT01893060|"~     Umbilical catheters are necessary for many infants admitted to the Newborn Intensive Care~     Unit (NICU)and utilized when indicated for up to 7 to 14 days. Bacterial colonization can~     occur at the umbilical stump and potentially lead to serious bloodstream infections (BSIs).~     This study is a prospective, randomized controlled feasibility trial to evaluate three types~     of hygiene products on umbilical line stumps, on the effect of line colonization and~     subsequent infections. Infants admitted to the NICU with an umbilical line(s) will be~     randomized into one of four study groups, three products against standard of care (no~     product). The three products that will be evaluated are currently being used in different~     capacities for skin care in the University of Virginia (UVA) NICU. The study hypothesizes~     that twice daily topical application of 1 or more antiseptic to the top of the umbilical~     stump will decrease colonization of the umbilical stump while umbilical lines are in place.~   "
127916|NCT01893047|"~     A mother of a preterm infant listening to music while pumping her breasts will produce more~     milk than a similar mother who is not listening to music. A mother listening to live music~     will produce more milk than a mother listening to recorded music~   "
127917|NCT01893034|"~     Femoroacetabular Impingement (FAI) describes a condition of the hip where additional bone~     results in the abutment of the femoral neck against the rim of the acetabulum. This gives~     rise to localised cartilage damage and pain, but also increases the risk of developing~     osteoarthritis. The purpose of this study is to compare the effectiveness of arthroscopic~     surgery versus physiotherapy and activity modification for the treatment of this condition.~   "
127918|NCT01893021|"~     The purpose of this study is to understand the family planning needs and practices of~     postpartum Malawian women, with a focus on long-acting reversible contraception (LARC).~      Hypotheses:~        1. Postpartum women who are older, who have a history of unintended pregnancy, who do not~          desire another child within 2 years, and who were counseled about LARC during their~          pregnancy are more likely to have interest in using LARC.~        2. Postpartum women who are older are more likely to be aware of LARC methods.~        3. HIV+ postpartum Malawian women will have similar knowledge about LARC as postpartum~          Malawian women who are HIV-.~   "
127919|NCT01893008|"~     The PREPARE study is the first multicenter randomized controlled trial to evaluate the~     hypothesis that preoperative inspiratory muscle training leads to decreased pulmonary~     complications in patients undergoing esophageal resection.~   "
127920|NCT01892995|"~     This study will enroll patients presenting to the emergency department with acute suicidal~     ideation meeting inclusion and exclusion criteria. Patients will be randomized to one of~     three arms: ketamine (intervention) or diphenhydramine (control) or placebo (control). Serial~     measurements will be made in the ED and at follow-up intervals.~   "
127921|NCT01892982|"~     The investigators' goal is to optimize the developmental outcomes of preterm infants by~     preventing depression and improving functioning among their mothers during the critical first~     year of life. The investigators are conducting a randomized controlled trial of a replicable,~     lay-delivered intervention - the basic approach of which is to use an empirically-supported,~     cognitive behavioral strategy to help mothers solve their unique daily problems and address~     some of the predictable challenges to parenting a preterm infant.~   "
127922|NCT01892969|"~     Project Summary We propose an ancillary study to The Heart and Lung Failure Pediatric Insulin~     Titration trial (HALF PINT), which is investigating the impact of normalizing blood glucose~     using insulin infusions on clinical outcomes among children with hyperglycemia and heart and~     lung failure. In this ancillary study, we will measure plasma levels of inflammatory,~     coagulation, and fibrinolysis proteins and genotype DNA for polymorphisms among patients~     enrolled in the HALF PINT trial. The results from this ancillary study will help us to~     understand potential mechanisms through which normalizing blood glucose provides benefit,~     which may lead to development of new therapeutic strategies in critically ill children~   "
127923|NCT01892956|"~     Categorization of glucose levels into 'healthy', 'pre-diabetic' or 'diabetic' is increasingly~     seen as artificial. Furthermore, most micro and macrovascular complications may be present~     already at the pre-diabetic stage.~      Hyperglycemia, pre-diabetes and impaired glucose tolerance (IGT) are fully reversible, thus,~     maintaining normal blood sugar levels is crucial for the prevention and control of diabetes~     and the various other consequences of the metabolic syndrome. Only interventions that are~     individually tailored can achieve proper glycemic control, and the glycemic index (GI), which~     quantifies the glycemic response to particular foods, was developed for this purpose.~      In this study the investigators will characterize the blood glucose responses and microbiota~     of healthy individuals, aiming to assess the influence of food intake on gut microbiota and~     the influence of gut microbiota on glycemic responses.~   "
127924|NCT01892943|"~     The objective of this survey is to establish the clinical course of vision loss and recovery~     in patients with a genetically confirmed diagnosis of Leber Hereditary Optic Neuropathy~     (LHON).~      Visual acuity changes over time from onset of symptoms and from visual acuity nadir will be~     the main endpoint analysed.~      The survey will collect historically documented visual acuity data for all patients at~     participating sites with a genetically confirmed diagnosis of LHON. No exclusion criteria~     apply. Patients are not required to attend the clinic for the survey.~      Data will be collected in a completely anonymous manner. Ethical approvals and data release~     agreements will be obtained as required by local regulations.~   "
127925|NCT01892930|"~     This pilot clinical trial studies stereotactic body radiation therapy in treating patients~     with metastatic kidney cancer undergoing surgery. Stereotactic radiation therapy may be able~     to send x-rays directly to the tumor and cause less damage to normal tissue.~   "
127926|NCT01892917|"~     This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring~     coronary revascularization with Drug Eluting Stents (DES)~   "
127927|NCT01892904|"~     The is a multi-center, randomized, open-label, active-controlled, parallel-group comparative~     study (24-week treatment period).~      The objective of this study is to prove the superiority of BAY 86-5300 with flexible extended~     regimen for treatment of dysmenorrhea to BAY 86-5300 with 28-day cyclic regimen in terms of~     primary efficacy variable, number of days with dysmenorrheic pain over 140 days of evaluation~     period.~      In addition, the long-term safety of the flexible extended regimen of BAY86-5300 in patients~     treated for one year will be investigated.~   "
127928|NCT01892891|"~     VBY-036 may treat or prevent nerve pain. This study aims to find the highest safe and~     tolerable dose of VBY-036 in healthy volunteers. Volunteers will be randomly selected to~     receive either a placebo or VBY-036 (30, 100, 300, 600 or 900 mg) once daily for seven days~     in a row.~   "
127929|NCT01892878|"~     The purpose of this clinical study is to evaluate fusion of the facet joints in a prospective~     cohort of patients utilizing the VerteLoc facet fixation device in patients receiving lumbar~     laminectomy (L1-S1), without ancillary stabilization devices such as pedicle and transfacet~     screws.~   "
127930|NCT01892865|"~     This study compares two different methodologies of scheduling cases in the operating room.~   "
127931|NCT01892852|"~     The purpose of this study is to evaluate whether acupuncture can be effective for~     chemotherapy-induced peripheral neuropathy in lymphoma or multiple myeloma patients.~   "
127932|NCT01892839|"~     Hemodialysis keeps patients with renal failure alive but does not restore normal health.~     Retention of chemicals that bind to plasma proteins and are therefore poorly removed by~     dialysis may contribute to ill health in patients receiving conventional treatment. This~     proposal will test the effect of a new method designed to improve the removal of~     protein-bound solutes during dialysis. The effects on blood chemical levels of two different~     dialysis prescriptions will be tested in patients already undergoing nocturnal in-center~     hemodialysis three times weekly.~   "
127933|NCT01892826|"~     The rational of the study is to assess the pregnancy rate after the transfer of frozen~     blastocyst in natural cycle controlled by external administration of hCG.~   "
127934|NCT01892813|"~     The project is designed to examine the effectiveness of strategies to increase access to~     treatment for tobacco use and dependence among rural Veteran smokers. In addition, it will~     examine whether tailored treatment that is designed to address common comorbid conditions~     that are related to cigarette smoking enhances success with quitting relative to enhanced~     standard of care. The investigators hypothesize that participants assigned to the tailored~     tobacco cessation intervention will report greater cessation rates at six months. The~     investigators also anticipate more favorable outcomes on measures of depressive symptoms,~     alcohol use, and body weight.~   "
127935|NCT01892800|"~     The purpose of this study is explore the impact of lung cancer surgery on the function of the~     right side of the heart.~   "
127936|NCT01892787|"~     The airways in the lungs get smaller the further into the lungs they go. Most simple~     measurements of lung function only reflect the larger 'central' airways and do not provide~     information on the smaller 'peripheral' airways. Newer measurements have been developed that~     can now give us accurate information on how the smaller airways are working. Indeed the small~     airways seem to play a significant role in asthma in terms of inflammation and airway~     narrowing. Recently, new types of inhaler formulations have been developed that have a much~     smaller particle size than other standard formulations. These formulations have been shown to~     go further into the lungs, thus getting into the smaller airways. In this study we aim to~     compare the two extremes of available long acting beta agonists in terms of particle size~     i.e. extra fine formoterol (Atimos) versus coarse particle salmeterol (Serevent)in asthmatics~     with abnormal small airway function using a breathing test called impulse oscillometry. By~     using this test we will be able to find out whether using an extrafine particle inhaler~     improves small airway function.~   "
127937|NCT01892774|"~     This study would assess the impact of radio-frequency catheter ablation on exercise capacity~     and quality of life in long-standing persistent atrial fibrillation (LSP-AF) patients~   "
127969|NCT01892345|"~     The primary objective of the study is to assess the efficacy and safety of eculizumab~     treatment as compared to placebo in relapsing NMO patients using a time to first relapse~     study design.~   "
129545|NCT01871727|"~     The purpose of this trial is to assess the efficacy and safety of E7777 (improved purity~     ONTAK) in patients with persistent and recurrent cutaneous T-cell lymphoma. A lead-in~     dose-finding part will be used to determine the dose of E7777 that should be used to test~     efficacy and safety.~   "
127938|NCT01892761|"~     Adequate exposure to mycophenolic acid (MPA) is associated with better outcomes in kidney~     transplantation. This study evaluated repeated, MPA pharmacokinetics (MPA-PK) according to~     post-transplant time-points and concomitant CNIs. Fifty-two patients, 33 allocated to~     tacrolimus (TCL) and 19 to CyA (all with mycophenolate mofetil (MMF) and steroids), had the~     full MPA area under the time-concentration curve (AUC0-12hrs) repeatedly evaluated at days 7,~     14, 30, 60 and 180 post-transplant. MMF daily dose was lower in TCL group as per protocol.~     Dose-adjusted MPA-AUC0-12hrs progressively increased throughout the study period in both~     groups but profiles were different according to the CNI regimen and time. The majority of~     patients were underexposed to MPA on day 7 for both groups what reinforces the need of a~     higher dose in the first week. Dose-adjusted MPA-AUC0-12hrs was higher in TCL group, after~     day 7, due to both a diminished MPA clearance (for both groups) and higher AUC4-12hrs in the~     TCL group. There was a progressive overexposure to MPA in order that at day 180, 21-30% of~     the patients were overexposed to MPA what indicates a time for MPA monitoring and dose~     correction for long-term follow-up. These PK data suggest that changes in MPA profile occur~     according to time and CNIs used and suggests that MPA monitoring may be mandatory at specific~     time-points.~   "
127939|NCT01892748|"~     The potential role of vitamin D on disease susceptibility, activity and severity has been~     considered for several autoimmune rheumatologic diseases include systemic lupus erythematosus~     (SLE) . Although, there are few studies of vitamin D supplementation in SLE patients,~     especially in Juvenile Onset Systemic Lupus Erythematosus (JoSLE).~      The objective of this study is to evaluate the effect of vitamin D supplementation~     (cholecalciferol 50.000 international units (IU)/week for 24 weeks) on disease activity~     (clinical and laboratory parameters), fatigue and bone mass.~   "
127940|NCT01892722|"~     To evaluate the safety and efficacy of fingolimod vs. interferon beta-1a i.m. in pediatric~     patients with multiple sclerosis~   "
127941|NCT01892709|"~     This is an exploratory, hypothesis-generating safety and efficacy study for patients who come~     to the ER in acute (less than 7 days in duration) severe pain. Patients with chronic pain~     will not be enrolled. Eligible patients will receive up to a maximum of 4 mg IV hydromorphone~     over a 4 hour period. Hydromorphone will be given as 1 mg increments based on how the patient~     responds to the question, Do you want more pain medicine?. This question will be asked~     repeatedly 30 minutes after the patient answers no or 30 minutes after the most recent dose~     of IV hydromorphone (which occurs if the patient answers yes). Up to 10% (approximately 30~     patients) will serve as a pilot at the start of the study.~   "
127942|NCT01892696|"~     The clinical usefulness of inspiratory flow pattern manipulation during mechanical~     ventilation remains unclear. The aim of this study was to investigate the effects of~     different inspiratory flow waveforms, i.e. constant and decelerating, on cardiac preload in~     mechanically ventilated patients assessed by arterial pulse pressure variation (PPV) and~     inferior vena cava distensibility.~   "
127943|NCT01892683|"~     This trial investigates the relationship between concentrations of the anesthetic drug~     propofol in exhaled breath and blood in patients undergoing general anesthesia for elective~     surgery. The main goal of this study is to develop a population pharmacokinetic model for~     propofol in exhaled breath.~   "
127944|NCT01892670|"~     In a combat situation the need for safe and high-quality blood products is increasing. WB~     (Whole Blood) is used in many trauma situations, but we wish to investigate whether there is~     an even better whole blood product.~      The purpose of this study is to examine the quality of leucoreduced, cold-stored whole blood.~     We also wish to examine the effects of filtration of whole blood without a 1-2 hour~     holding-time (warm-filtration) and the effects of forced filtration. We also wish to explore~     the possibility of using cold-stored WB for production of RCC.~      Analyses are performed with a main focus to investigate function and quality of red blood~     cells and platelets.~   "
127945|NCT01892657|"~     This study examined the possible sensitization and irritation effects of a moisturizer with~     sunscreen SPF 50+.~   "
127946|NCT01892644|"~     Hypothesis: Deferasirox can be used as a therapeutic agent to deplete the liver, heart and~     bone marrow of excess iron in patients with iron overload caused by myelodysplastic syndrome~     (MDS) and hemochromatosis (HC.~      Assess the effect of new serum biomarkers (NTBI and hepcidin) and MRI as indicators of iron~     overload and their usefulness to monitor iron depletion treatment.~      Study the effect of iron overload and iron depletion on intracellular signal transduction,~     trace metals concentrations in serum and urine and markers of oxidative stress in blood cells~     and urine.~   "
127947|NCT01892631|"~     Influenza morbidity and mortality cause a substantial financial burden to the NHS and to the~     UK as a whole. Influenza vaccine is safe and effective but is required annually because the~     circulating strain of virus changes each year. In the UK in 2012, the Chief Medical Officer~     (CMO) recommended that at least 75% of elderly people (aged 65+) and 75% people under 65 with~     certain chronic conditions (e.g. chronic heart disease, diabetes, asthma, etc) should be~     vaccinated. While primary care practices are achieving these targets for elderly patients,~     those set for younger patients with chronic conditions are not being met, with a third of~     patients being missed in the 2011/12 flu season and with no substantial improvements in~     uptake in the past decade. Therefore strategies to increase flu vaccine uptake in these~     patients are required.~      Previous trials have shown that patient reminders can increase vaccine uptake and in~     particular, text messaging has shown to work in some populations in the United States as a~     cheap, simple and effective reminder. However, whether the same is true in UK general~     practice is unclear. The use of text messaging in the NHS for appointment reminders is also~     increasing as it is cheap, quick and effective. Text messaging is already used in roughly 30%~     of practices to remind patients about their flu vaccine but there has been no trial~     addressing its effectiveness. Therefore, we propose a trial of a text messaging flu vaccine~     reminder in patients aged under 65 who have a chronic condition. We hypothesise that~     practices that send a text message will have increased flu vaccine uptake.~   "
127948|NCT01892618|"~     The purpose of the study is to determine whether patients with chronic lymphocytic leukaemia~     (CLL) will benefit from vaccination with a 13-valent conjugated pneumococcal vaccine,~     Prevenar13, compared with a conventional 23-valent capsular polysaccharide vaccine in terms~     of immune response.~   "
129546|NCT01871714|"~     The current study design incorporates two previously developed, non-invasive approaches to~     characterize the phenotype of individuals affected with XLHED.~   "
127949|NCT01892605|"~     Music has a long history in healing physical and mental illness. The Mozart effect was~     initially reported by Rauscher, Shaw, and Ky in the journal of Nature in the year of 1993.~     They examined performance on Stanford-Binet spatial tasks immediately following either 10~     minutes of listening to Mozart's sonata K.448, silence, or instruction to relax. They found~     the performance scores were 9 point higher in Mozart-listening group than other two groups.~     Later, the beneficial influence of Mozart music on parkinson's disease, epilepsy, senile~     dementia, and attention-deficit/hyperactivity disorder was reported. However, the real~     neurophysiological mechanism of the influence remains unclear.~      Epilepsy is a common disorder in the field of pediatric neurology. Although we had greatly~     advanced in develop of new anticonvulsant, thirty percent of patients with epilepsy have~     drug-resistance, which is associated with an increased risk of debilitating psychosocial~     consequences. In addition, the adverse effects of anticonvulsants are not uncommon. Few~     reports demonstrated that patients exposed to Mozart's music can significantly decrease in~     seizure frequencies and interictal epileptiform discharge. However, the case number of these~     studies was limited and the mechanisms of music therapy on epilepsy were not well known. In~     our recent studies, Mozart's music indeed decreased the epileptifrom discharge in the~     patients with epilepsy, particularly in the patients with generalized discharge and central~     discharge. On the basis of these encouraging results, we will try to investigate the neural~     mechanisms and clinical applications of music therapy in the following three years.~      In the first year of our study, we use animal model to examine the possible mechanism of~     Mozart's effect. The aim of the second year study is investigation the effect of music on the~     cortical functions in the epileptic rat model. According to our previous study, Mozart's~     sonata K.448 was effective in reducing epileptiform discharge. On the basis of previous~     two-year results, the patients with epilepsy will be enrolled in the third year project to~     perform an individualized music therapy. In this study, we can provide an alternative therapy~     in the patients of epilepsy and investigate the possible biological mechanism of music~     effect.~   "
127950|NCT01892592|"~     The goal of this pragmatic study is to improve hypertension (HTN) control rate in blacks and~     to reduce racial disparity in HTN control. To accomplish this, the investigators propose to~     perform a cluster randomized controlled trial at the primary care provider (PCP) level and~     including 191 PCPs within KPNC East Bay Service Area with more than 45,000 patients in the~     HTN registry of which approximately 15,000 are black. The investigators will randomize all~     PCP patient panels to a three-arm trial to receiving either 1) usual care; or 2) culturally~     tailored diet and lifestyle coaching; or 3) an intensified BP management protocol with~     pharmacotherapy. The Shake, Rattle and Roll trial is named for: 1) shake the salt habit;~     2) rattle the intensity of current BP management; and 3) design the interventions with the~     goal of being able to adapt and roll them out to community clinics outside of a managed~     care system. Primary research question: whether a primary prevention intervention of either~     diet and lifestyle coaching or an intensive pharmacotherapy protocol is more effective than~     usual care in improving rates of HTN control in blacks and thereby reducing disparities~     between black and white. Primary aim: By implementing either intervention, the investigators~     will reduce the disparity in hypertension control rates between blacks and whites by 4% at 1~     year post-study enrollment. Hypothesis: Among blacks with HTN, a diet/lifestyle coaching~     intervention or an intensified BP management protocol will result in an increase in HTN~     control rate compared to usual care. Primary outcome: the proportion of patients with~     sustained BP control at 1 year post-study enrollment.~   "
127951|NCT01892579|"~     Over 5 million Americans have Alzheimer's disease or a related dementia, a progressive and~     irreversible neurodegenerative condition, affecting also close to 15 million family~     caregivers (CG). A hallmark of the disease and one of the most significant challenges in~     dementia care is neuropsychiatric symptoms (NPS) of which agitation is the most disabling and~     frequently occurring. It is associated with increased health care costs, reduced life~     quality, heightened caregiver burden, disease acceleration and nursing home placement.~     Treatment typically involves pharmacologic agents; however, these are at best modestly~     effective, carry serious risks including mortality, and may not reduce family distress.~     Recently issued position statements from medical organizations suggest nonpharmacologic~     strategies as first-line treatment. Nevertheless, nonpharmacological strategies for agitation~     remain understudied. We propose a Phase III efficacy trial to test a novel 8-session~     patient-centric intervention, the Tailored Activity Program. We will test the program using a~     randomized two-group parallel design of 250 people with dementia (PwD) and their CGs (dyads)~     who will be randomly assigned to received a program of tailored activities or a control~     intervention of equivalent in-home attention and social contact. The trial assesses PwDs'~     preserved capabilities, deficits, previous roles, habits, interests and home environment from~     which activities are developed to match PwD profiles. Families are trained to implement~     activities and modify them for future decline. Our primary study aim evaluates the effect of~     tailored activities at 3 months on agitation (Hypothesis: PwD in the tailored activity~     program will have less frequent agitation compared to the control intervention condition.~     Three secondary aims evaluate: 1) 6-month effects of tailored activities on agitation and~     quality of life in PwD (Hypothesis: PwD receiving tailored activities will manifest lower~     severity scores at 6 months and better quality of life compared to PwD in the control~     intervention); 2) Immediate effects of tailored activities at 3 and 6 months on CG wellbeing,~     and time spent providing care (Hypothesis: CGs receiving training in tailoring activities~     will report enhanced wellbeing and less time caregiving compared to the control intervention~     (3 and 6 months); and 3) Cost effectiveness of the Tailored Activity Program expressed as an~     incremental cost outcome achieved in the form of CG burden reductions and willingness to pay~     for burden reductions (3 and 6 months; Hypothesis: Tailoring activities will be cost~     effective compared to the control intervention at each test occasion). Exploratory aims will~     evaluate treatment effects on psychotropic medication use and other troublesome behaviors, if~     effects differ by cognitive status, if CGs receiving the tailored activity program will use~     activities at 6 months and with what frequency, how time gained is spent, and if~     frequency/duration of treatment and activity use affects outcomes. If proven efficacious and~     cost effective, the Tailored Activity Program has potential to transform clinical practice by~     offering a proven nonpharmacologic treatment for agitation of PwDs at home. This trial~     addresses a critical clinical need and public health priority identified by recent~     legislative activity.~   "
127952|NCT01892566|"~     Investigators propose to develop methods to improve early identification of acute~     exacerbations of COPD (AECOPD) among HIV-infected individuals. Investigators hypothesize that~     earlier identification of acute exacerbations through in-home monitoring of respiratory~     symptoms, lung function and medication usage will allow appropriate intervention to reduce~     the morbidity associated with AECOPD. Therefore, the investigators propose using innovative~     mobile health (mHealth) applications to Respond Early to Acute exacerbations of COPD in HIV~     (mREACH). COPD is a co-morbidity of HIV with growing recognition, but remains greatly~     under-recognized among HIV-infected persons. In this application, among HIV-infected~     individuals with spirometry-confirmed COPD, investigators will conduct a pilot randomized~     trial of mHealth monitoring compared to usual care to reduce the symptom and clinical burden~     of AECOPD.~   "
127953|NCT01892553|"~     Dyspnea is a frequent, mostly unpleasant and long-lasting, but also often undertreated~     symptom. Transcranial direct current stimulation (tDCS), a new non invasive method to modify~     brain activation has shown good efficacy in the treatment of pain especially in the clinical~     context. Given the fact that dyspnea has many common characteristics with pain, especially~     concerning the brain areas involved in its central processing, we hypothesize that tDCS may~     also modify the perception of dyspnea. In order to test this, we first shall determine~     whether tDCS has a significant effect on acutely induced dyspnea in healthy volunteers. In~     case of promising results of this pilot study, the next step will be the evaluation of the~     benefit of tDCS in patients with severe dyspnea.~   "
127954|NCT01892540|"~     This clinical trial studies positron emission tomography (PET)/computed tomography (CT) or~     PET/magnetic resonance imaging (MRI) in measuring tumors in patients undergoing clinical~     imaging or with newly diagnosed breast cancer. New diagnostic procedures, such as PET/CT or~     PET/MRI, may be more effective than MRI alone in measuring tumors in patients undergoing~     clinical imaging or with newly diagnosed breast cancer.~   "
127955|NCT01892527|"~     This is a single-arm, Simon 2-stage, phase 2 clinical study conducted in subjects with~     advanced or metastatic colorectal cancer who have previously received ≥ 1 prior line of~     systemic therapies and are resistant to EGFR inhibitor (cetuximab or panitumumab).~      This trial will be conducted to determine objective response rate (ORR), progression-free~     survival (PFS) and overall-survival (OS) of cetuximab plus tivantinib in patients with~     wild-type KRAS CRC that is resistant to anti-EGFR antibody treatment (cetuximab or~     panitumumab) and shows overexpression of cMET.~   "
127970|NCT01892332|"~     Epidural lidocaine is widely used in anesthesia for urologic or lower abdominal surgery~     because of its rapid onset. But the epidural anesthesia using high concentration of lidocaine~     may cause excessive motor block and unwanted side effects such as nausea, vomiting and~     hypotension.~      This is a study to determine the effective concentration of lidocaine with fentanyl in lumbar~     epidural anesthesia for transurethral resection of prostate in elderly patients.~   "
127971|NCT01892319|"~     This study is conducted in Europe and Asia. The purpose of the study (Diabetes Pregnancy~     Registry) is to evaluate the safety of treatment with insulin detemir in pregnant women with~     diabetes mellitus.~   "
128088|NCT01890798|"~     This is a single arm, open-label continued access protocol of drisapersen for the treatment~     of male subjects with Duchenne muscular dystrophy (DMD) having dystrophin mutations~     correctable by drisapersen-induced DMD Exon 51 skipping. The purpose of this continued access~     protocol is to offer pre-approval access to drisapersen for the treatment of subjects with~     DMD who previously participated in eligible drisapersen studies. The protocol will collect~     safety data required to assure subject safety and periodic efficacy data on muscle function.~   "
127956|NCT01892514|"~     Femoral head avascular necrosis is a relatively common disease (10,000 - 20,000 yearly new~     United States of America cases) characterized by ischemic cell necrosis in a hip proximal~     epiphysis area frequently requiring total Hip Arthroplasty (THA).~      Even though THA resolves symptoms and restores good joint function, young patients are prone~     to major disabilities and require prosthesis revision surgeries.~      In this clinical trial a comparison between two groups of patients, treated with the same~     procedure but with two different regenerative techniques, will be performed:~        1. 52 patients with necrosis in an early stage, without deformity of the femoral epiphysis~          (stage 2A-B-C in Association for Research on Osseous Circulation (ARCO) classification,~          will undergo wide decompression of the necrotic area and reconstruction with homologous~          Lyophilized Bone Chips (LBC), growth factors from platelet concentrate Platelet-Rich~          Fibrin (PRF) and Concentrated Bone Marrow (CBM).~        2. 52 patients with necrosis of similar features, without deformity of the femoral~          epiphysis, will undergo wide decompression of the necrotic area and reconstruction with~          Demineralized Bone Matrix (DBM), growth factors from Platelet-Rich-Fibrin (PRF) and~          Concentrated Bone Marrow (CBM).~      Patients will be evaluated post-surgery at 6 weeks, 3, 6, 12, and 24 months to assess joint~     damage evolution by ARCO classification, and hip function by clinical scores (Harris Hip~     Score (HHS), Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score, and~     Visual Analogic Scale (VAS)).~   "
127957|NCT01892501|"~     Impact of screening nodes mediastinal by PET, at different times of the management of cancer~     disease, remain unclear.~      Benefits of combined PET and puncture with echoendoscopy for the diagnosis subsequent~     therapeutic management should be evaluated in these different contexts.~      We would like to demonstrate the clinical utility of this association to replace more~     invasive diagnostic procedures and to assess the impact of the puncture on a possible~     modification of the therapeutic management.~      It is a single center prospective diagnostic assessment~   "
127958|NCT01892488|"~     The ultimate goal is to reduce unnecessary antibiotic prescriptions which drive the~     development of antibiotic resistance in the community. The primary objective of ABACOPD is to~     demonstrate in a sufficiently sized clinical study that there is no relevant increase in the~     failure-rate for patients with acute moderate exacerbations of COPD (AE-COPD) treated with~     placebo instead of antibiotic treatment both on top of standard of care. A patient is~     classified as treatment failure if additional antibiotic therapy is required during treatment~     period or until the test of cure visit (TOC at day 30, primary endpoint).~   "
127959|NCT01892475|"~     The purpose of this study is to test the overall effects of incentives on physical activity~     among older taxi drivers, and whether mental accounting exists in this context.~   "
127960|NCT01892462|"~     The purpose of this study is to determine whether levels of inflammatory markers in~     circulating blood can correlate with risk for dangerous heart rhythms. Patients with systolic~     heart failure, which has been shown to increase risk for dangerous heart rhythms, will be~     enrolled. All subjects will have an implantable cardioverter-defibrillator (ICD) in place,~     which allows regular evaluation of heart rhythm.~   "
127961|NCT01892449|"~     The steep trendelenburg position and pneumoperitoneum during laparoscopic surgery have the~     potential to cause an adverse effects on respiratory mechanics and gas exchange. Previous~     studies have proposed that a prolonged I:E ratio ventilation improved respiratory mechanics~     and gas exchange. Therefore, the aim of this study is to evaluate whether a prolonged I:E~     ratio ventilation improves gas exchange and respiratory mechanics in patients undergoing~     robot-assisted laparoscopic radical prostatectomy.~   "
127962|NCT01892436|"~     This study is designed as a 3-year extension to the phase III core study CAIN457F2306. It~     aims to provide continuous treatment with secukinumab in pre-filled syringes (PFS) for~     subjects who completed the core study CAIN457F2306, to obtain further long term efficacy,~     safety and tolerability information in subjects with active psoriatic arthritis receiving~     secukinumab every 4 weeks. At Week 104 of the study CAIN457F2306, eligible subjects will~     complete the assessments associated with the core study visit and will subsequently continue~     in the extension study on the same dose that they were receiving during the core study. The~     regular assessments of disease activity will ensure that subjects who are experiencing~     worsening of disease in any of the treatment groups can exit the study upon their own wish or~     based on the advice of the investigator at any time.~   "
127963|NCT01892423|"~     Human repeat insult patch test to assess the potential for Cetaphil Moisturizing Lotion Daily~     Advance to induce sensitization to the skin~   "
127964|NCT01892410|"~     Determine if Cetaphil Restoraderm Skin Restoring Body Wash proves to be a contact sensitizer~     or irritant in certain individuals.~   "
127965|NCT01892397|"~     The purpose of this study is to find out what effects, good or bad, the Optune device has on~     the patient and meningioma. This study is being done because currently there are no proven~     effective medical treatments for a progressive meningioma that has failed surgery and/or~     radiation. The study uses an experimental device called Optune. Optune is experimental~     because it has not been approved by the U.S. Food and Drug Administration (FDA) for this type~     of tumor, although it has been approved for a different type of brain tumor.~   "
127966|NCT01892384|"~     The primary objective of the current study is to investigate the safety and tolerability of~     BI 409306 in schizophrenic patients following oral administration of multiple low, medium,~     and high doses over 14 days.~      A secondary objective is the exploration of the pharmacokinetics and pharmacodynamics of BI~     409306 in schizophrenic patients.~   "
127967|NCT01892371|"~     The goal of the Phase 1 part of this clinical research study is to find the highest tolerable~     dose of AC220 (quizartinib) that can be given with either 5-azacitidine (azacitidine) or~     cytarabine to patients with AML or MDS.~      The goal of the Phase 2 part of the study is to learn if quizartinib with either azacitidine~     or cytarabine can help to control AML or MDS. The safety of these combinations will also be~     studied.~      This is an investigational study. Quizartinib is not FDA approved or commercially available.~     It is currently being used for research purposes only. Cytarabine and azacitidine are FDA~     approved and commercially available for certain types of MDS and AML. The study drug~     combinations are investigational.~      Up to 72 participants will be enrolled in this study. All will take part at MD Anderson.~   "
128089|NCT01890785|"~     Compare the pharmacokinetic profiles when the contents are emptied into a soft food and~     orange juice compared to the SPD489 when swallowed as an intact capsule.~   "
127972|NCT01892306|"~     The specific goal of this research study is to investigate the feasibility, acceptability,~     and preliminary efficacy of a transdiagnostic, cognitive-behavioral therapy developed~     specifically to target common core processes across mood and anxiety disorders [Unified~     Protocol for Transdiagnostic Treatment of Emotional Disorders (UP)], for the treatment of~     patients with bipolar I disorder (BD-I) and comorbid anxiety. The study will compare~     treatment-as-usual with pharmacotherapy (TAU) plus 18 one-hour sessions of treatment with the~     UP to TAU alone. Patients in both treatment conditions will be followed over a 12-month~     period and will be assessed monthly to track changes in mood, anxiety and emotion-related~     symptoms; functional impairment; and relapse rates. Data on the acceptability of the~     treatment will be gathered concurrently through monthly patient self-reported ratings of~     treatment satisfaction, and by tracking rates of acceptance for randomization into the study,~     number of completed sessions, and dropout rates. The study will examine: 1) whether combined~     cognitive behavioral treatment (UP) for BD-I and comorbid anxiety disorders is an acceptable~     and feasible approach to treatment; 2) whether treatment with the UP for BD-I and comorbid~     anxiety disorders as an adjunct to pharmacotherapy treatment-as-usual (TAU) leads to greater~     symptom reduction and reduced functional impairment than pharmacotherapy alone, 3) whether~     treatment for BD-I and comorbid anxiety disorders with the UP improves relapse rates over a~     6-month follow-up relative to TAU; and 4) whether reduction in symptoms, relapse rates, and~     functional impairment are mediated by changes in emotion regulation skills. The broader aim~     of this study is to address the need for improved treatments for bipolar disorder.~   "
127973|NCT01892293|"~     This study will enroll patients with multiple myeloma who have received prior therapy for~     their disease but their disease has progressed or relapsed.~   "
127974|NCT01892280|"~     The purpose of this 18-month randomized controlled trial (RCT) is to find out if (1) a set of~     psychoeducational materials for teens with type 1 diabetes and (2) text message reminders to~     check blood glucose levels can help improve blood glucose levels in teens with type 1~     diabetes.~   "
127975|NCT01892267|"~     Our main hypothesis is that self-propelled Percutaneous Endoscopic Gastrojejunostomy tube~     (PEG-J) that has a balloon on it's tip is associated with lower J-tube retrograde migration~     rate, and lower rates of short- and long-term complications when compared to standard PEGJ~     feeding tubes.~   "
127976|NCT01892254|"~     This study investigates the incretin effect in women with polycystic ovary syndrome (PCOS)~     before and after removal of their insulin resistance by metformin.~      The investigators' hypothesis is that insulin resistant women with PCOS have a reduced~     incretin effect and elevated glucagon responses as measured by a 75-g oral glucose tolerance~     test and isoglycemic i.v. glucose infusion. The investigators hypothesise that both can be~     improved when their insulin resistance is removed.~   "
127977|NCT01892241|"~     Patients with spontaneous decline of HBV DNA were non-randomly assigned to accept~     peginterferon alfa-2a or entecavir therapy, or didn't accept any antiviral regiment.~   "
127978|NCT01892228|"~     The aim of the study is to measure the effectiveness of a pilot program in Guangxi, China to~     decrease mortality related to HIV.~      The study's proposed mechanism of decreasing mortality rates is to shorten the time between~     initial HIV screening and ART implementation to within two weeks.~      The study population consists of participants who received an initial HIV infection diagnosis~     within the study period. Medical institutions will provide one-stop services by following~     detailed guidelines regarding reporting of positive HIV antibody screenings, further testing~     procedures, and treatment referrals in accordance with a pre-determined timetable. In~     addition, additional strategies focusing on policy development, medical personnel training,~     and a broad general public education campaign will be implemented.~      Main assessment measures are HIV-related mortality rates, treatment coverage, or other health~     outcomes.~   "
127979|NCT01892215|"~     Obstetrical blood loss is an important reason of maternal morbidity and mortality. Because of~     the increase in the rate of cesarean section, any procedure that could help reduce blood loss~     during cesarean section should be investigated. The purpose of this study was to compare 2~     methods of blunt expansion of the uterine incision at the time of cesarean delivery:~     transversal vs. cephalad-caudad.~   "
127980|NCT01892202|"~     This multicenter observational study will evaluate the efficacy and safety of Mircera~     (methoxy polyethylene glycol-epoetin beta) in patients with chronic kidney disease not on~     dialysis in routine clinical practice. Eligible patients treated with Mircera for chronic~     renal anemia according to the standard of care and in line with the current local label will~     be followed for 6 months.~   "
127981|NCT01892189|"~     The purpose of this study is to determine whether ketamine-induced brain activity changes are~     modulated by TAK-063 administration using neuroimaging battery tests.~   "
127982|NCT01892176|"~     The investigators hypothesise that measuring biomarkers of oxidative damage could better~     inform investigators on the potential merits (and pitfalls) of CoQ10 supplementation in PD~     subjects.~   "
127983|NCT01892163|"~     Multicentre randomized controlled trial to evaluate whether 5 monthly fixed dosing of 700 µg~     Dexamethasone Posterior Segment Drug Delivery System (Ozurdex) is as efficacious as Optical~     coherence tomography (OCT)-guided PRN dosing in patients with refractory diabetic macular~     edema.~   "
127984|NCT01892150|"~     Anti-inflammatory and anti-oxidant agents have become the important ingredients in sunscreen.~     However, there is no histologic study about the effects of anti-inflammatory and~     anti-oxidative properties of sunscreen to prevent premature aging from UVA and UVB.~   "
127985|NCT01892137|"~     The main purpose of this trial is to demonstrate the predictive value of the clinical~     diagnosis of clearance of Actinic Keratoses after treatment with Ingenol Mebutate using~     histopathological examination as the standard.~   "
127986|NCT01892124|"~     American Indians (AIs) living in the Northwest have very high rates of diabetes, obesity,~     tobacco use, depression, and other risk factors associated with cardiovascular disease.~     Depression and diabetes have a pernicious effect on CVD risk and susceptibility. This study~     seeks to build upon the success of the 1-month, 5-session motivational interviewing (MI) CVD~     prevention component of the həli?dxw Project (aka Healthy Hearts-originally funded under~     RFA-HL-06-002; U01 HL HL087322-05). həli?dxw successfully culturally adapted MI for CVD~     prevention for AIs, trained AIs to implement the intervention, and conducted a preliminary~     feasibility and efficacy trial. Initial results indicated that participants enthusiastically~     embraced the MI component of the program; however, observations of the counselors, survey~     data, and feedback from participants suggest that depressive symptomatology served as a~     barrier to achieving CVD preventive behaviors and desired outcomes; and, that more time and~     attention to underlying depressive symptomatology may enhance motivation and CVD prevention~     behaviors, particularly among AIs with pre-diabetes and Type 2 diabetes. Building upon solid~     preliminary CVD epidemiological data, preliminary acceptability and feasibility of utilizing~     an MI approach, and motivated by the need to address elevated depression and diabetes~     profiles from the həli?dxw study, the investigators will develop a 3-month, 10-session~     MI-based cognitive-behavioral-adherence (MI-CBT-CVD) treatment program to address underlying~     depressive symptomatology, activate CVD prevention behaviors, and decrease BMI and CVD risk~     behaviors among 50 pre-and recently diagnosed diabetic AIs at risk for CVD. The study~     proposes three innovative and significant aims. First, in line with community-based~     participatory (CBPR) principles and pre-established indigenous research protocols with the~     tribal community, the investigators will conduct formative research to develop the MI-CBT-CVD~     intervention. Second, the investigators will conduct a pilot randomized two-group,~     single-site waitlist-controlled clinical trial of a 10-session, 3-month MI-based~     cognitive-behavioral treatment for CVD prevention (MI-CBT-CVD) among 50 pre-and recently~     diagnosed diabetic AI adults with depressive symptomatology and who are also at risk for CVD.~     Assessments will be conducted at pre and post intervention and at 6-months (3 month~     follow-up). Third, the investigators will disseminate the findings to the tribe as well as~     research outlets and prepare an RO1 to conduct a full-scale RCT should the pilot intervention~     be efficacious, acceptable to the community, and feasible. The primary objectives will be to~     determine the effect of the proposed culturally-grounded behavioral intervention program on~     (a) reducing weight as measured by BMI (7-10% reduction in BMI); (b) decreasing depressive~     symptomatology; (c) increasing physical activity; (d) decreasing sedentary activities; (d)~     increasing healthful food habits; and (e) improving biomedical outcomes (e.g., blood lipid~     profiles, glucose, hemoglobin A1C, and blood pressure). The intervention will be culturally~     relevant and utilize existing Native resources and personnel wherever possible.~   "
128063|NCT01891123|"~     As cytotoxic agents, DTX and PTX have a narrow therapeutic window. BSA dosing leads to great~     inter-individual PK variability, which is a major contributor for severe toxicity, especially~     in East-Asian populations. DTX exposures measured by area under plasma concentration-time~     curve (AUC), PTX exposures measured by the time above a plasma concentration of 0.05 µmol/L~     (TC>0.05), are the most biologic effects associated PK parameters for DTX and PTX,~     respectively, which could positively predict related toxicities such as neutropenia,~     peripheral neuropathy, etc. So, we conducted a randomized clinical trial to compare the~     effect on related toxicities and efficacy of PK-guided dosing strategy and BSA dosing~     strategy.~   "
127987|NCT01892111|"~     Obese women experience increased infertility rate and longer time to conception showing lower~     pregnancy and live-birth rates both in natural and assisted conceptions. Body weight loss~     improves not only spontaneous pregnancy rates but also those of assisted reproductive~     techniques (ARTs). Almost all studies refer to body weight loss due to lifestyle intervention~     programs consisting in hypocaloric diet and increased physical activity, whereas very little~     is known about the specific effects of physical activity alone on human reproduction.~      In a previous retrospective study, we demonstrated that physical activity enhances the~     reproductive performance of obese infertile patients who receive in vitro fertilization (IVF)~     and intracytoplasmic sperm injection (ICSI) cycles, regardless of body weight loss.~      The aim of this randomized controlled trial (RCT) will be to evaluate if a structured~     exercise program improve the effectiveness of ARTs.~   "
127988|NCT01892098|"~     The purpose of the study is to determine the effects of zinc supplementation on bone growth~     over four weeks. Participants will agree to attend two visits to our laboratory and at each~     will complete blood and urine samples, questionnaires related to diet and physical activity~     and will receive a bone scan at the first appointment.~   "
127989|NCT01892085|"~     Compelling evidence exists that breast milk helps protect very premature infants from~     prematurity-specific morbidities. Unfortunately, mothers of premature infants often exhibit~     delayed lactogenesis stage II (when the milk comes in) and decreased breast milk~     production. Several studies have linked earlier initiation of breast milk expression~     following delivery with a greater milk production. However, none conclusively determined the~     optimal timing of breast milk expression. As a result these mothers continue to struggle with~     inadequate breast milk production. This study will follow 180 mothers of premature infants~     for 6 weeks following delivery to test~      Earlier initiation of breast milk expression following delivery is associated with (1) an~     earlier lactogenesis stage II, (2) greater volume of breast milk production during the first~     6 weeks, (3) improved short-term infant health outcomes and (4) women who deliver at an~     earlier gestation will have decreased milk production and a later lactogenesis stage II.~     Following stratification according to the gestational age of the infant (23-27 weeks vs.~     28-32 weeks), eligible women will be randomly assigned to one of three groups and instructed~     to start mechanically expressing their r breasts, either in the first hour, 1-3 hours or 3-6~     hours following delivery. The timing of lactogenesis stage II will be documented, and the~     volume of breast milk produced will continue to be measured for the first 6 weeks following~     delivery and at discharge. Infant nutritional outcomes will be measured throughout the 6-week~     study. The impact of the differences in timing of initiation of milk expression following~     delivery on timing of lactogenesis stage II, milk volume, short term nutritional outcomes,~     amount of breast milk feedings at discharge, and impact of gestational age on milk volume and~     lactogenesis stage II will be determined.~   "
127990|NCT01892072|"~     The investigators study the VEGF signaling in HCC cell lines and its mechanism in HCC growth,~     proliferation and apoptosis.~   "
127991|NCT01892059|"~     The purpose of this study is to compare the efficacy and safety of the segmental artery~     clamping and main renal artery clamping during laparoscopic partial nephrectomy~   "
127992|NCT01892046|"~     Heat shock protein 90 (Hsp90) is a chemical in the body that is involve in the promotion of~     cancer. SNX-5422 is an experimental drug that blocks Hsp90.~   "
127993|NCT01892033|"~     The overall aim of this pilot feasibility study is to determine if 12-week moderate intensity~     exercise can safely alleviate posttraumatic symptoms in premenopausal women veterans.~      Specific aims of the study are to;~        1. Determine the feasibility, safety, and tolerability of 12-week moderate intensity~          exercise~        2. Explore potential therapeutic benefits of 12-week moderate intensity exercise. Outcome~          data will include posttraumatic and depressive symptoms.~        3. Explore potential therapeutic effects of a 12-week moderate intensity exercise on~          comorbid pain syndrome and quality of life.~   "
127994|NCT01892020|"~     This trial is conducted in Asia. The aim of the trial is to investigate the efficacy and~     safety of biphasic insulin aspart 50 (BIAsp 50) twice daily versus biphasic human insulin 50~     (BHI 50) twice daily, both in combination with metformin, in Chinese subjects with type 2~     diabetes mellitus.~   "
127995|NCT01892007|"~     A double-blind randomised active-controlled trial aims to assess whether Cogmed (adaptive)~     working memory training results in improvements in untrained measures of cognition, speech~     perception and self-reported hearing abilities in older adults (50-74 years) with~     mild-moderate hearing loss who are existing hearing aid users, compared with an active~     placebo Cogmed (non-adaptive) control. It is hypothesised that improvements on trained Cogmed~     tasks, representing increased working memory capacity, will result in improved performance on~     cognitive and speech perception tasks that engage working memory. We also measure~     self-reported hearing ability to assess self-perceived benefit of Cogmed training.~   "
127996|NCT01891994|"~     Background:~      - Eltrombopag is a drug being tested for treating severe aplastic anemia. It can help improve~     blood counts in these patients. However, researchers do not know how long the drug can and~     should be taken for this type of anemia.~      Objectives:~      - To look at whether 6 months of treatment with eltrombopag can improve patient s blood~     counts.~      Eligibility:~      - Individuals at least 2 years of age who are taking eltrombopag for severe aplastic anemia.~      Design:~        -  Participants will take eltrombopag by mouth once a day for 6 months.~        -  Blood samples will be collected every 2 weeks for the first 6 months. Bone marrow~          samples will be collected at 3 and 6 months. These samples will look at the effects of~          the study drug on the marrow.~        -  Participants will continue to take the study drug for as long as it is effective and if~          the side effects are not severe.~   "
127997|NCT01891981|"~     The goal of this clinical research study is to find the highest tolerable dose of moxetumomab~     pasudotox that can be given to patients with relapsed and/or refractory ALL.~   "
127998|NCT01891968|"~     The goal of this clinical research study is to learn if bortezomib can help to control MDS.~     The safety of this drug will also be studied.~      Bortezomib is designed to block a protein that causes cells to grow. This may cause cancer~     cells to die.~   "
127999|NCT01891955|"~     The purpose of this study is to compare two healthy diets (according to official Spanish~     guidelines) that have been shown to be effective in the treatment of type 2 diabetes in order~     to see if one is better than the other.~      Another goal is to test the hypothesis that food choice has metabolic effects that are~     independent of macro/micronutrient composition, fiber content, glycemic load and weight loss~     in the treatment of type 2 diabetes.~   "
128000|NCT01891942|"~     The inspiratory pressure trigger is essential when assessing the twitch mouth pressure (Tw~     Pmo) for avoiding glottic closure. However, the difference in inspiratory pressure trigger~     threshold may influence the values of Tw Pmo. We sought to determine the trigger threshold~     for healthy subjects and COPD patients.~   "
128101|NCT01890629|"~     To compare efficacy and safety of initial combination therapy of Gemigliptin versus~     Sitagliptin or Glimepiride with Metformin on Glucose Variability(MAGE, Glucose SD) in~     Patients With Type 2 Diabetes Mellitus.~   "
128001|NCT01891929|"~     This study, driven on schizophrenic patients, is aimed at :~        1. Measuring the efficiency of the cognitive remediation program RECOS (COgnitive~          REmediation in Schizophrenia) on the capacity of the patients suffering from~          schizophrenia to improve the integration in sheltered employment (ESAT and EA).~        2. Comparing the efficiency of the program of cognitive remediation RECOS (RECOS arm) to~          the one of an usual program of coverage/care (TAU arm = Treatment As Usual) on~          integration in sheltered employment of patients suffering from schizophrenia.~        3. Realizing a comparative analysis, in both arms, of :~             1. the number of working hours achieved in sheltered environment during the 6 months~               following the two programs (reported to the working time planned by the contract of~               employment)~             2. the duration of such employments in sheltered areas.~        4. Estimating the impact of RECOS on the neuropsychological variables, the symptomatology,~          the consciousness of the disorders(insight), the quality of life and the social autonomy~          before the treatment (month M0), at the end of the treatment (month M3), and 6 months~          later (month M9), and looking for a correlation between the improvement of these~          parameters and sheltered employment.~        5. Estimating the impact of cognitive remediation on integration in sheltered employment.~   "
128002|NCT01891916|"~     Food allergy (FA), defined as an adverse immune response to food allergens, is among the most~     frequent allergic disorders in childhood and it has recognized as a major paediatric health~     problem due to the severity of the reactions and the dramatic increase over the past decades.~     Cow's milk allergy (CMA) is the most frequent FA in children worldwide, and it has been~     demonstrated that it could be the first manifestation of the so-called atopic march,~     characterized by the occurrence of other allergic disorders in the subsequent years after the~     onset of CMA. In a previous study, involving children with CMA over a period of 5 years, 40%~     developed asthma, 21% atopic eczema, and 43% allergic rhinitis. Similar results have been~     reported in a recent study on Finnish children Intestinal microflora appears to have a~     crucial role in the development of atopic disorders. Children with atopic diseases have~     different commensal bacterial groups in the gut compared to non-atopic children, and~     differences are also found between countries with high and low incidence of atopic diseases.~     There is currently great interest in manipulating the normal microbiota to accrue health~     benefits through an approach known as probiotics. Probiotics are defined as live~     microorganisms which when administered in adequate amounts confer a health benefit on the~     host. The conceptual basis of possible use of probiotics in the prevention and treatment of~     atopic disorders is well grounded. Lactobacillus GG (LGG) is the most studied probiotic in~     the prevention and treatment of atopic disorders. Wide and well-designed clinical studies~     have provided several evidences on the efficacy of LGG as preventive or therapeutic strategy~     in pediatric atopic disorders. More recently, in vitro studies have provided evidences on the~     potent immunoregulatory role and on the influence on intestinal microflora composition~     (toward a more beneficial composition in the prevention and treatment of atopic disorders)~     elicited by LGG. This view has been further reinforced by recent research showing that LGG is~     able to improve recovery of intestinal symptoms in infants with CMA-induced allergic colitis.~   "
128003|NCT01891903|"~     TO TRANSALETE AND VALIDATE DE TORONTO PSORIATIC ARTHRITIS SECREENING QUESTIONAIRE INTO~     SPANISH~   "
128004|NCT01891890|"~     Seizures that arise in specific areas in the brain are called Localization Related Epilepsy~     (LRE) and are the most common seizure disorder in children. Children that receive drug~     treatment for this disorder may suffer from treatment related side effects which impact their~     ability to think or concentrate and their ability to interact socially. These negative~     treatment effects can impact the child's performance in school and long term may impact~     employment and job options.~      This study will determine whether changes in attention and social interactions are seen in~     children treated for LRE using three of the most common medications used to treat pediatric~     LRE. Children who are newly diagnosed with LRE by their doctors and are between the ages of 5~     years 6 months and 16 years 0 months will be randomized to receive levetiracetam,~     lamotrigine, or oxcarbazepine.~      There will be 14 study sites throughout the US. Children will undergo evaluation of their~     thinking and ability to pay attention before and after starting drug treatment for LRE.~     Regardless of the specific findings, results of this study will provide the information~     needed to help parents and their clinicians choose treatment options that maximize cognitive~     abilities in children with LRE, and provide the data needed for practice guidelines to be~     established on the basis of cognitive side effect risks.~   "
128005|NCT01891877|"~     This study will look at the five different types of sickle cell and their relation to~     self-reported ill health to determine whether or not one or two of the sickle cell haplotypes~     are correlated with worse health outcomes. Participants can do complete the study in under~     half an hour in the privacy of their own home.~   "
128006|NCT01891864|"~     The purpose of this study is to demonstrate equivalent efficacy of GP2015 and Enbrel® in~     patients with moderate to severe chronic plaque-type psoriasis with respect to PASI 75~     response rate at Week 12.~   "
128007|NCT01891851|"~     The purpose of this study is to evaluate the drug-drug interaction between steady-state~     concentrations of CYP3A4 or ritonavir and TMC435350 after its first and the last dose of the~     multiple dosing regimen and to explore the short term safety and tolerability of multiple~     doses of 200 mg of TMC435350 administered alone and in combination with 100 mg of ritonavir.~   "
128008|NCT01891838|"~     The risk of bleeding is important during transsphenoidal surgery. This study aims to find if~     the ventilation mode, controlled pressure and controlled volume, modifies the risk of~     bleeding.~   "
128009|NCT01891825|"~     Persistent atrial fibrillation (AF) is a common and distressing condition, that can cause~     significant symptoms. AF ablation is a recognised technique to treat persistent AF, but can~     be technically difficult. This study compares percutaneous ablation to thoracoscopic surgical~     AF ablation.~   "
128010|NCT01891812|"~     Patients who have sickle cell VOC are usually treated with opioids, such as morphine.~     However, this current way of treating them has not improved the health, medical outcomes, or~     rates of hospitalizations. In addition, since VOC can happen very frequently over a long~     period of time, giving opioids over and over again can cause both short-term and long-term~     problems. Nitrous oxide (N2O) is a way of treating pain that may provide a better alternative~     to repeatedly giving opioids over long periods of time. N2O has been shown to provide up to 3~     hours of pain relief in inpatient patients with VOC whose pain did not improve with morphine~     infusions, and is used extensively in France, where almost half of 85 pediatric emergency~     departments use nitrous oxide to treat children with VOC whose pain did not get better with~     standard treatment with morphine. However, pain relief which N2O provides in the acute~     setting has not been well described. Therefore, the purpose of our study is to describe how~     well N2O can relieve the pain in patients with SCD who present to the emergency department~     and are experiencing a VOC.~   "
129547|NCT01871701|"~     To evaluate the corrected QT interval change(automatic-reading) after single oral~     administration of escitalopram, quetiapine and moxifloxacin versus placebo in healthy Korean~     Adults.~   "
128011|NCT01891799|"~     The purpose of this study is to understand how best to provide care and treatment services to~     human immunodeficiency virus (HIV) positive pregnant women and their babies in Swaziland. The~     study is designed to evaluate a new approach for Preventing Mother-to-Child Transmission~     (PMTCT)where all HIV positive pregnant women initiate lifelong triple antiretroviral (ARV)~     therapy regardless of their disease stage. The goal is to prevent delays in women accessing~     treatment for their own health and ensure that women and their children remain in care. This~     study will compare this new approach to PMTCT, known as Option B+, to Option A, which is the~     current standard of care for PMTCT in Swaziland. The study will be conducted at 10 health~     facilities in the Manzini and Lubombo regions in Swaziland. The study has three components:~     the main component is a PMTCT Options Evaluation where data from medical records will be~     abstracted on all HIV positive pregnant women attending antenatal services at the 10 selected~     study facilities; data will be abstracted on their HIV exposed infants as well. Other~     components of the study include a PMTCT Options Acceptability Evaluation using~     semi-structured questionnaires with PMTCT clients and health care workers (HCWs) as well as a~     cost effectiveness evaluation comparing costs under conditions of Option A and Option B+.~   "
128012|NCT01891786|"~     The primary objective of the CORDIA study is to use an effective evidence-based~     self-management intervention (SMI) for type 2 diabetes, with and without a novel test to give~     a personalised genetic and lifestyle risk of coronary heart disease, to examine their~     capacity to reduce the risk of coronary heart disease (CHD) and improve diabetes management~     in primary care patients with type 2 diabetes. The effect of these interventions on clinical,~     behavioural and psychological outcomes will be investigated.~   "
128013|NCT01891773|"~     Asthma is the most common chronic pediatric disease in the United States, and is the most~     common cause of school absenteeism due to a chronic disease. Socioeconomically disadvantaged~     minority children receive disproportionately poor asthma care and incur a disproportionate~     share of asthma-related morbidity. The District of Columbia is particularly severely~     affected, with a lifetime asthma prevalence rate among children 0-17 years of age in 2010 of~     22%, more than double the national average.~      One of the major challenges in treating asthma is poor adherence to daily controller~     medications, particularly inhaled corticosteroids (ICS) which are the cornerstone of the NIH~     guidelines for asthma management. In an attempt to overcome poor compliance, investigators in~     Rochester, New York have partnered with primary care providers in their community to arrange~     for ICS administration at school by school nurses, and this approach yielded significant~     improvements in several asthma outcomes.~      The investigators propose to collaborate in a pilot research project with the overall goal of~     improving asthma outcomes through reducing barriers to medication adherence. Specifically,~     the investigators aim to improve adherence to controller medications (inhaled corticosteroids~     - ICS) among DC children with asthma through the following activities:~        1. A pilot prospective randomized clinical trial of home vs. school administration of ICS~          among DC children in grades kindergarten-8 with persistent asthma.~        2. Qualitative interviews with nurses from DC public and public charter school to identify~          key barriers to administration of daily controller medications in the school setting~   "
128014|NCT01891760|"~     -  Observe the long-term (1-year) outcomes of Dermagraft, compared with conventional~          treatment of four-layer compression bandaging therapy alone, in subjects who completed~          the ABH-Dermagraft-001-08 study.~        -  Study Hypothesis: N/A (Long-term follow-up study)~   "
128015|NCT01891747|"~     This is a Phase I/II non-randomized prospective study of high-dose L-methylfolate in~     combination with bevacizumab and temozolomide in patients with recurrent high-grade glioma.~     The primary objective of this phase II trial is to determine whether the addition of~     high-dose L-methylfolate to bevacizumab and temozolomide therapy improves progression-free~     survival (PFS) compared to previously reported results.~   "
128016|NCT01891734|"~     This project will be the first to evaluate the Moving Forward app in VA. Identifying an~     effective treatment for anxiety and depression in primary care is imperative within Veterans~     Health Administration as they are both common, chronic, and debilitating conditions~     associated with a number of personal and health-related costs. In close partnership with app~     developers at Mental Health Services, a major contribution of this research is the actionable~     feedback on the acceptability, feasibility and effectiveness of augmenting traditional~     Problem Solving Therapy with the Moving Forward app for future app development. If~     effectiveness can be established, Moving Forward has the potential for integration into the~     larger continuum of care for depression and anxiety in Primary Care-Mental Health Integration~     (e.g., care management, co-located collaborative care). Lastly, this pilot project will~     provide preliminary data for future research on SmartPhone technology. Veteran feedback on~     treatment components, ease of executing the study successfully and preliminary effect size~     calculations, will inform the design of the larger project.~   "
128017|NCT01891721|"~     Cognitive dysfunction is a major contributor to the poor community outcome of individuals~     with schizophrenia. Developing more effective cognitive remediation interventions is~     imperative to improve the daily lives of affected subjects and reduce the disability of this~     illness. The goal of this clinical trial is to evaluate two types of cognitive training~     approaches to determine which one is more beneficial for individuals with schizophrenia. This~     study also uses electrophysiological techniques to gain a better understanding of the~     mechanisms involved in cognitive remediation. Findings from this study will provide~     information about how to design the most optimally efficient cognitive training intervention~     to improve the cognitive and social functioning of patients with severe mental illness.~   "
128018|NCT01891708|"~     a. VEGFRs may be the biomarker which can predict the effect of bevacizumab in non small cell~     lung cancer~   "
128076|NCT01890954|"~     The purpose of this study is to use a closed-loop Control-to-Range (CTR) system in~     adolescents with type 1 diabetes in an outpatient setting, and to evaluate the CTR system's~     ability to significantly improve blood glucose levels when an insulin bolus is omitted for a~     30 gram carbohydrate snack and when insulin bolus is insufficient for the amount of~     carbohydrates consumed for a meal. The primary objective of this study is to use a~     closed-loop Control-to-Range (CTR) system to significantly reduce the post-prandial blood~     glucose excursion in adolescents with type 1 diabetes who omit and/or under-bolus insulin for~     either snacks or meals. Up to 20 subjects aged ≥13 and ≤18 years old will be tested.~   "
128019|NCT01891695|"~     The dose of radiation most commonly used to treat oropharyngeal cancer results in side~     effects including sores in the mouth and throat, dry mouth and thick saliva, loss or altered~     taste, swallowing problems including pain or inability to swallow requiring feeding tubes to~     be placed in the stomach, hoarseness or breathing problems from swelling requiring~     tracheostomy or a hole surgically placed in the windpipe to allow the patient to breathe,~     nausea and vomiting, fatigue and loss of energy, decreased hearing from fluid behind the ear~     drums in the middle ear, skin redness tenderness and blistering.~      The purpose of this study is to determine if the investigators can reduce the dose of~     radiation to the lymph nodes in the neck that may contain cancer cells that are not detected~     by physical examinations or radiologic studies (CT scans, PET CT scans, or MRI scans) in~     order to reduce the side effects from treatment and still adequately kill any cancer cells~     that may be contained in those lymph nodes.~   "
128020|NCT01891682|"~     Critically ill children have abnormal utilization of nutrients such as glucose, lipids and~     protein. Protein synthesis is increased mainly in the form of immune and signaling proteins,~     while synthesis of muscle and structural proteins is decreased. The metabolism of sulfur~     amino acids and specifically methionine and cysteine have not been investigated in critically~     ill septic children, despite that sulfur amino acids have important roles on thiol,~     antioxidant and epigenetic reactions, as well as precursor of glutathione (GSH). Methionine~     metabolism in critically ill children will be influenced by its rate of utilization through~     the transmethylation, remethylation and transsulfuration pathways, which are the major~     pathways of methionine metabolism.~      The investigators study aims to investigate the metabolism of methionine and cysteine in~     parenterally fed critically ill septic children. The investigators aim to determine the rates~     of transmethylation, remethylation, transsulfuration and GSH synthesis rates in critically~     ill septic children, to determine in vivo, whole body sulfur amino acid metabolism when~     sulfur amino acids are supplied by the parenteral route. The objective is to determine~     whether current parenteral intakes support GSH synthesis and if methionine metabolism differs~     when supplied by the parenteral versus the enteral route. Methionine parenteral requirements~     will be also studied by using the indicator amino acid oxidation and balance technique.~   "
128021|NCT01891669|"~     To assess the safety and tolerability at increasing dose levels of PF-06263507 in patients~     with advanced solid tumors in order to determine the maximum tolerated dose and select the~     recommended Phase 2 dose.~   "
128022|NCT01891656|"~     Substance abuse treatment in the criminal justice system can reduce drug use and related~     criminal behavior. Although drug and alcohol treatment are common mandates in criminal~     justice programs, only a minority of clients actually initiate treatment. This proposal will~     compare two intervention formats that target motivation to initiate and engage in treatment~     among a group of probationers who have drug or alcohol treatment conditions. Six hundred drug~     and alcohol offenders in two probation sites (Baltimore, MD and Dallas, TX) will be~     randomized to receive: 1) an in-person motivational interviewing session (MI), 2) a~     motivational computer program (MC), or 3) supervision intake and monitoring as usual (SAU).~     The MI condition will be structured along the lines of the Check-Up format which consists~     of an assessment and personalized feedback delivered in an MI style; the content of the MC~     condition will be drawn from previous literature on effective motivational computer programs.~     Both interventions will be delivered at the start of the probation process, with follow-up~     assessments at 2 and 6 months. Primary outcomes include engagement and participation in~     substance abuse treatment; secondary outcomes include drug and alcohol use, probation~     progress, criminal behavior, and HIV testing and care. This project will be the first to~     develop and test two interventions for encouraging criminal justice clients to follow through~     with treatment recommendations, with the goal of increasing treatment initiation, and~     reducing subsequent drug use and criminal behavior. It also contributes to ongoing~     partnerships with two large probation agencies—the Dallas County Supervision and Corrections~     Department and the Maryland Division of Parole and Probation.~   "
128023|NCT01891643|"~     The purpose of the study is to look at subjects who receive Lenalidomide, Dexamethasone, and~     Elotuzumab and determine if they will have lower surface CS1 expression on malignant plasma~     cells at the time of progression than those who receive Lenalidomide and Dexamethasone~     without Elotuzumab~   "
128024|NCT01891630|"~     To determine if baseline asthma control influences susceptibility to pollutant-induced health~     effects in African-American children with moderate-to-severe asthma.~   "
128025|NCT01891617|"~     Determine whether the mid-day suppression of hunger and amplified increase in the release of~     glucose-dependent insulinotropic peptide (GIP) and glucagon-like peptide 1 (GLP-1) following~     morning exercise is due to increased fat content of the diet per se or a combination of high~     fat diet after morning exercise. The action of gut peptides, particularly GLP-1, on gastric~     emptying is likely to be important in mediating its effects on postprandial appetite and~     glycemia (Nauck et al. 1997). Our hypothesis is that exercise amplifies gut peptide secretion~     when diet is enriched with fat, and that this stimulus suppresses the hunger sensation.~   "
128026|NCT01891604|"~     Prophylactic enteral probiotics may enhance clinical markers and biomarkers of preterm~     infants' health, and may also play a role in reducing NEC and associated morbidity.~   "
128027|NCT01891591|"~     This study is aimed at assessing how Roux-en-Y gastric bypass (RYGP) impacts on energy and~     nutrients' intake, energy expenditure, and nutritional status in obese patients. It will try~     quantitate energy and protein balance after RYGP, and to identify how RYGP effects the intake~     of various common dietary protein sources 16 female patients with BMI > 40 kg/m2 and on a~     waiting list for bariatric surgery will be included. The following measurements will be~     performed before, and 1, 3, 6, 12, and 36 months after RYGP~        -  body weight~        -  body composition (bio impedancemetry)~        -  basal metabolic rate (open circuit indirect calorimetry)~        -  24-hour urinary urea excretion~        -  fasting blood chemistry~        -  energy and macronutrient's intake (3-day dietary recall)~   "
128028|NCT01891578|"~     Evaluation of immunological reconstitution after haploidentical BMT using a nonmyeloablative~     preparative regimen and post-transplant cyclophosphamide in patients with poor prognosis~     lymphoma~   "
128077|NCT01890941|"~     The purpose of this study is to evaluate the efficacy and safety of KCT-0809 compared to~     placebo in patients with dry eye syndromes.~   "
128029|NCT01891565|"~     The amount of active therapy provided to patients on an inpatient stroke rehabilitation unit~     has been reported as often insufficient. Observational studies have found that in the first~     14 days post stroke, patients receive very little therapy and have very low activity levels.~     More opportunity to practice may, however, improve short-term outcomes such as the level of~     mobility, endurance, use of the affected arm and leg, and length of stay. The Stroke~     Inpatient Rehabilitation Reinforcement of ACTivity (SIRRACT) trial will utilize sensors that~     reveal the type, quantity, and aspects of quality of patient activities outside of the~     confines of research laboratories. SIRRACT will deploy inexpensive Personal Activity Monitors~     (PAMs), comprised of triaxial accelerometers worn on the thighs.~      The objectives of the study are:~      i. To assess the impact of feedback from Personal Activity Monitors (PAM)s on amount of~     active practice, walking speed and distance in stroke patients undergoing rehabilitation.~      ii. To assess the impact of feedback from PAMs on physical, psycho-emotional, cognitive and~     ecosocial Health-Related Quality of Life of stroke patients undergoing rehabilitation.~      iii. To assess the acceptability of thigh-strapped accelerometer use among stroke patients~     undergoing rehabilitation.~      iv. To assess the reliability and validity of thigh-strapped accelerometer use among stroke~     patients undergoing rehabilitation.~      Hypotheses In moderate to severely disabled subjects who are receiving in-patient~     rehabilitation, daily feedback from PAMs about purposeful activity will increase the amount~     of active practice by >30%, a higher proportion of subjects who reach the level of~     independence for walking, and increase walking speed by 25%, leading to higher mean walking~     speeds and distances at the time of discharge from inpatient rehabilitation. Daily feedback~     from PAMs on increase in walking speed and distances will improve physical, psychological,~     cognitive and ecosocial domains of Health-related quality of life.~   "
128030|NCT01891552|"~     -  The recently introduced chemoembolization has been considered to be a very attractive~          new method in terms of response in the treatment of liver metastases from colon cancer~          carcinoma (LM-CRC). It appears to be particularly useful if carried out with the new~          embolization materials.~        -  An 80% response rate was reported using TACE with Irinotecan pre-loaded Beads in~          patients with liver metastases from colon cancer, who had been pretreated with 2 or more~          lines of chemotherapy.~        -  Since a greater activity was attained by a combination of Cetuximab and Irinotecan~          versus Cetuximab in monotherapy, the European Agency for the Evaluation of Medicinal~          Products (EMEA) has granted authorization to the use of Cetuximab in association with~          irinotecan in the treatment of irinotecan-refractory CRC-LM.~        -  In this study we want to collect data on on time to progression and tolerability using~          DEBIRI+Cetuximab in LM-CRC~   "
128031|NCT01891539|"~     Hepatocellular carcinoma (HCC) is the fifth most common type of cancer in men and the seventh~     in women and is the third most common cause of death from cancer worldwide. The overall~     incidence of HCC remains high in developing countries and is steadily rising in most~     industrialized countries.~      TACE with Doxorubicin-eluting beads (DEB-TACE) has recently been developed as a novel therapy~     option for HCC. In order to maximize its therapeutic efficacy, doxorubicin-loaded beads were~     developed to deliver higher doses of the chemotherapeutic agent and to prolong its permanence~     within the tumor. The comparison of efficacy and safety of TACE with drug-eluting~     microspheres in comparison with conventional TACE (cTACE) showed that response and time to~     progression in the group was significantly higher than that of the cTACE group. TACE with~     drug-eluting microspheres thus appears to be a feasible and promising approach to the~     treatment of HCC.~      This study's purpose is evaluating treatment efficacy, survival rate and safety of TACE using~     drug-eluting microspheres loaded with doxorubicin for unresectable hepatocellular carcinoma.~   "
128032|NCT01891526|"~     To test whether patients with hepatic insufficiency can tolerate one oral dose of~     9-cis-retinoic acid and to test whether the metabolism of retinoic acid is altered.~   "
128033|NCT01891513|"~     The purpose of this study is to compare, when combined with chronic exercise, the effects of~     perindopril, losartan, and hydrochlorothiazide.~   "
128034|NCT01891500|"~     The investigators in this study are concerned about the harmful effects of oxygen exposure in~     newborn infants, particularly at high concentrations. Inhaled nitric oxide (iNO) is an FDA~     approved drug for the treatment of hypoxic respiratory failure (HRF) in term and late-preterm~     babies greater than 34 weeks gestation. Hypoxic respiratory failure occurs when a patient's~     lungs cannot get enough oxygen into their bloodstream. This condition is traditionally~     treated with high concentrations of oxygen and most often requires the patient be placed on a~     ventilator (breathing machine). The administration of inhaled nitric oxygen directly into the~     lungs often improves blood oxygen levels and allows caretakers to reduce the amount of oxygen~     given to the baby. The purpose of this research study is to evaluate if giving the inhaled~     nitric oxide earlier in the course of disease improves the effectiveness of the drug, reduces~     the amount of cellular injury from oxygen exposure, and decreases the total amount of time a~     patient requires supplemental oxygen. This study uses an FDA approved drug in a new manner.~   "
128035|NCT01891487|"~     This is a study researching the safety and efficacy of Bimatoprost 0.03% soultion versus~     placebo applied to the eyebrow for the treatment of thinning eyebrows. This is a 36 week~     study where Bimatoprost 0.03% solution/placebo will be applied once daily to the subjects~     eyebrow for duration of the study.~   "
128036|NCT01891474|"~     Ubiquitous healthcare service for elderly patients with type 2 diabetes have been developed~     and improved glycemic control. However, previous U-healthcare service had some limitations,~     which needs specific devices to check blood glucose and send it to central system. Voice~     inception technique based U-healthcare service is expected to improve glycemic control~     without specific devices.~      To evaluate the clinical efficacy of this system, researchers plan to compare the improvement~     of glycemic control, self-management, and quality of life between U-health care group~     (intervention) and conventional treatment group (control).~   "
128037|NCT01891461|"~     The purpose of this study is to compare Floseal to our standard of care (SOC) to decrease~     intraoperative and immediate post-operative bleeding.~   "
128078|NCT01890928|"~     Critically ill children have abnormal utilization of nutrients such as glucose, lipids and~     protein. Often sick children have increased glucose concentrations in blood. However, the~     origin of the high glucose has not been determined in these populations. There is a close~     interrelationship between protein and energy metabolism. An increase in the energy supply~     will not promote nitrogen retention unless the amino acid supply is adequate, and conversely,~     an increased amino acid supply will be useless if energy is limiting, hence the importance of~     adequate protein and energy intake. Our study aims to investigate the protein-energy~     interactions in critically ill septic children and adolescents with the objective to~     eventually provide the best nutritional support for these patients.~   "
128102|NCT01890616|"~     In this research study the investigators want to learn more about gut transit times in~     Duchenne Muscular Dystrophy (DMD) patients over 18.~      The investigators hypothesized:~        1. DMD patients will exhibit prolonged gut transit times when compared to the general~          population;~        2. Abnormal transit times will correlate with increased age and worsening functional~          status.~   "
128038|NCT01891448|"~     The CONSORT (Consolidated Standards of Reporting Trials) Statement aims to improve the~     reporting of randomized trials. If trials are not well reported it is difficult for~     clinicians to use best evidence to inform clinical practice and patients may not get the best~     care. A number of different CONSORT extensions have been developed which specify additional~     information needed for more complex trials. The aim of this project is to evaluate whether~     using a simple web-based tool (WEBCONSORT) improves the reporting of clinical trials. The~     tool combines different CONSORT extensions and allows authors to obtain a checklist and flow~     diagram which is specific to their individual trial. In this study authors of participating~     journals are requested, at the manuscript revision stage, to use a web-based tool to improve~     the reporting of their randomized trial. Authors registering to use the tool are randomized~     to intervention or control. In the intervention group authors are directed to the WebCONSORT~     tool. In the control group, authors are directed to a different version of the WebCONSORT~     tool which includes the flow diagram part of the tool but not the main checklist or elements~     relating to CONSORT extensions. The aim is that this tool should lead to improvements in the~     reporting of randomized trials, making it easier for clinicians to read and interpret~     published findings.~   "
128039|NCT01891435|"~     A randomized clinical trial to check the antipyretic efficacy of oral and intravenous~     paracetamol and intramuscular diclofenac sodium in patients presenting with fever to~     emergency department.~   "
128040|NCT01891422|"~     The glycoproteinoses are among the most rare and least researched of the lysosomal diseases.~     The diseases include aspartylglucosaminuria, fucosidosis, galactosialidosis,~     alpha-mannosidosis, beta-mannosidosis, mucolipidosis II, mucolipidosis III, Schindler~     disease, and sialidosis. Longitudinal studies of these conditions are needed in order to~     better define how common the diseases are, identify clinical features which could contribute~     to early diagnoses, detail progression of the diseases, assess the supportive therapies~     currently used, and identify potential treatments. Laboratory tests will evaluate metabolic~     and genetic defects found in participants' blood and urine samples.~   "
128041|NCT01891409|"~     A proof of concept study to evaluate the feasibility of using the Shang Ring, a novel male~     circumcision device across all childhood age groups namely infants (under 1), 1-5 age group,~     6-12 age group and the 13-17 age group. The study will evaluate the safety, efficacy and~     course of wound healing when using the Shang Ring technique across the four childhood age~     groups.~   "
128042|NCT01891396|"~     The purpose of this study is to see if a single injection of Cingal into the knee provides~     safe relief of pain caused by osteoarthritis.~   "
128043|NCT01891383|"~     The objective of this study is to measure the frequency and clinical types of mild cognitive~     impairment (MCI) or dementia that occur among up to 150 military retirees with and without a~     history of traumatic brain injury (TBI) among residents of the Armed Forces Retirement Home,~     Washington D.C. and the Veterans Home of California-Yountville. Investigators will compare~     the characteristics of dementia in those who have had a prior TBI to the characteristics in~     those without a history of TBI. It is our hypothesis that the dementia or MCI among those~     with prior TBI has distinct neuropsychological features that distinguishes it from those with~     dementia or MCI without a history of TBI.~   "
128044|NCT01891370|"~     The purpose of this study is to get initial values (normal medians) for certain biochemical~     serum markers for pregnancy weeks 10-13. Also initial values for mean arterial blood pressure~     measurement and certain ultrasound measurement may be established.~   "
128045|NCT01891357|"~     The Neo-PREDICT-HER2 Study is phase II trial to validate predictive markers for the response~     evaluation of a combined chemo-immunotherapy in patients with HER2-positive early breast~     cancer. The only treatment arm consists of Paclitaxel 80 mg/m2 weekly for 12 weeks with~     lapatinib 750 mg P.O. daily and trastuzumab 2 mg/kg IV (loading dose 4 mg/kg) weekly for 12~     weeks.~   "
128046|NCT01891344|"~     The purpose of this study is to determine which patients with ovarian, fallopian tube, and~     primary peritoneal cancer will best respond to treatment with rucaparib.~   "
128047|NCT01891331|"~     CYP51 is an enzyme essential for fungal growth. Inhibition of CYP51 results in the~     accumulation of compounds toxic to the fungus. CYP51 is the target of the class of drugs~     referred to as 'azole antifungals'. The lack of selectivity by the azole antifungals is~     responsible for many of the side effects associated with these drugs. VT-1161 has been design~     to be safer and more active against the fungal species typically responsible for vaginal~     yeast infections (i.e. vulvovaginal candidiasis)~   "
128048|NCT01891318|"~     This Phase I/II trial studies the ability to stop brain metastases from coming back after~     treatment with radiosurgery followed by surgical resection. It will also evaluate the side~     effects of these combined treatments and help determine the best radiosurgery dose.~     Radiosurgery focuses the x-rays directly to the tumor and cause less damage to the normal~     tissue in the brain.~   "
128049|NCT01891305|"~     The purpose of this study is to determine if the novel oral agent VT-1161 is safe and~     effective in treating patients with moderate - severe tinea pedis (also referred to as~     athletes foot). VT-1161 has been designed to inhibit CYP51, an enzyme essential for fungal~     growth. Inhibition of CYP51 results in the accumulation of chemicals know to be toxic to the~     fungus. CYP51 is the molecular target of the class of drugs referred to as 'azole~     antifungals'. All currently approved azole drugs have poor selectivity for CYP51 and this~     results in many of the side effects associated with the azole antifungals. The safety profile~     of the class similarly limits use in chronic treatment of non-life-threatening fungal~     infections. A safer antifungal drug would improve treatment options for infections seen in~     otherwise healthy individuals where significant side-effect risks are unacceptable.~   "
128050|NCT01891292|"~     The purpose of this study is to determine whether enalapril or antioxidant therapy~     (N-Acetylcysteine) is effective in reducing microalbuminuria in children with sickle cell~     disease and and its progression to sickle nephropathy~   "
128051|NCT01891279|"~     In neonates with recent small bowel resection or congenital bowel anomalies (gastroschisis or~     omphalocele), does an elemental formula as compared to a partially hydrolyzed formula allowed~     the infant to wean off Total Parenteral Nutrition (TPN) earlier?~   "
128103|NCT01890603|"~     Cluster randomized controlled trial comparing care coordination incentives to pay for~     performance (quality measure) incentives in clinics on utilization, cost, quality, and~     patient experience.~   "
128052|NCT01891266|"~     Background:~      Osteoarthritis (OA) is the most common joint disease that causes symptomatic health problems~     in the elderly population. For some patients with knee OA, total knee arthroplasty (TKA) may~     be the only option that offers the possibility of reestablishing the patient's life quality.~      Surgery of TKA usually takes place in a complete bloodless field established by a tourniquet~     around the thigh. The method aims to reduce blood loss and give the surgeon better visibility~     during the operation. The method is, however, not without side effects as patients often~     experience severe pain and swollen leg in the time after surgery. Furthermore, has the method~     shown decidedly muscle- and nerve damage followed by prolonged rehabilitation and reduced~     physical function.~      It is, however, possible to perform the operation without the use of the tourniquet.~      Aim and hypothesis:~      The aim of the present study is to assess the effects of tourniquet use in TKA on physical~     function, early rehabilitation, pain and opioid consumption.~      Hypotheses H1: TKA without tourniquet leads to better physical function and early~     rehabilitation.~      H2: TKA without tourniquet causes less pain and opioid consumption H3: Recovery of mechanical~     lower limb function post TKA is faster without use of tourniquet.~      Methods:~      80 patients (40 in each group) all eligible for TKA will be consecutively recruited and~     randomized to A) TKA without tourniquet, B) TKA with tourniquet. Subjects will be evaluated~     before the operation (baseline) and 14 days, 3, 6 and 12 months after the operation.~      The primary outcome will be the change from baseline to 3 months in self-administered~     knee-function (KOOS-ADL subscale). Further, will we examine a number of pre-specified~     secondary outcomes, which include self-rated knee-related pain, symptoms, difficulty with~     sports and leisure activities, and quality of life. In addition, muscle function, physical~     performance, and the use of pain medication will be studied~      Impact of the project:~      The project design of this study will enable analyses for determining the impact of operating~     without tourniquet and whether such an intervention can in fact improve physical function,~     performance and quality of life within TKA patients. The results may impact notably on the~     patient level and possible redefine current surgical strategies. The societal perspective of~     the project is to remobilize patients faster, which may reduce hospital services and absence~     from work.~   "
128053|NCT01891253|"~     Measuring hemodynamic parameters in ventilated patients is important yet still complicated to~     perform. Inert gas rebreathing (IGR) showed promising results when being compared to other~     invasive as well as non-invasive techniques for the measurement of cardiac output. The aim of~     our study is to evaluate the feasibility of IGR in ventilated patients.~   "
128054|NCT01891240|"~     The overall objective of the IMPROvED project is to develop a sensitive, specific,~     high-throughput and economically viable early pregnancy screening test for preeclampsia.~      This will involve a multicentre, phase IIa clinical predictive study to assess and refine~     novel and innovative prototype tests based on emerging metabolomic and proteomic technologies~     developed by SMEs (small to medium size enterprise) within the consortium. The study will i)~     recruit 5000 first-time pregnant women; ii) establish a high calibre biobank, augmented by~     accurate clinical metadata; iii) determine whether prototype predictive assays and algorithms~     translate to the clinical environment; iv) assess potential synergy of a combined metabolomic~     and proteomic approach and v) progress regulatory approval and development of the selected~     test into the clinical arena.~   "
128055|NCT01891227|"~     Patients with pretreated, Her2-negative, advanced breast cancer will receive chemotherapy~     with capecitabine and bendamustine for a maximum of eight cycles and afterwards capecitabine~     alone until disease progression or unacceptable toxic effects. Safety assessments will be~     conducted in 3-weekly intervals, efficacy assessments (CT or MRI) will be conducted every 9~     weeks.~      Aim of this study is to determine whether treatment with capecitabine in combination with~     bendamustine is efficacious and safe.~   "
128056|NCT01891214|"~     The purpose of the study is to develop a validated French version of the IBDQ in a cohort of~     patients suffering from Inflammatory bowel diseases, namely Crohn's disease and Ulcerative~     Colitis.~   "
128057|NCT01891201|"~     The aim of this study was to assess whether administration of oxytocin intrapartum (Oxt) has~     any effect on Neonatal Primitive Reflexes (RNP) and if dose dependent. The secondary~     objective is to assess the effects on exclusive breastfeeding at 3 months~   "
128058|NCT01891188|"~     Clinical studies are required to validate the hepatic NIRS monitor with other regional and~     global hemodynamic parameters and to evaluate its clinical use for continuous non-invasive~     hemodynamic monitoring. Using newer NIRS sensors the correlation between hepatic regional~     oxygen saturation and hepatic venous oxygen saturation (SvHO2) needs to be determined. If~     found to correlate then the NIRS can be used to evaluate early liver transplant failure~     and/or hepatic artery thrombosis, used as an early marker for shock, and necrotizing~     enterocolitis, and finally used in the outpatient setting to evaluate patients with chronic~     liver pathologies. If our validation study finds that NIRS monitors are an appropriate marker~     of hepatic venous saturation then it will lead to further clinical studies.~   "
128059|NCT01891175|"~     The hypotension defined as 20 % less than the basal SBP (systolic blood pressure)and / or an~     absolute value <90-100 mmHg, he presents an incident of 80-85% after an anesthesia intradural~     in the pregnant women, fact that worries for provoking undesirable effects so much in the~     mother and as in the fetus /newborn baby.~      The purpose of this study is to determine the effectiveness of intermittent pneumatic~     compression system in the lower extremities in order to reduce the vasopressors drugs~     requirements to maintain hemodynamic stability in pregnant women undergoing elective~     caesarean sections with an spinal anaesthesia.~   "
128060|NCT01891162|"~     Age, parity, obesity and a number of comorbidities are the major clinical and lifestyle risk~     factors for female urinary incontinence and pelvic organ prolapse at the population level.~     The socioeconomic risks for incontinence have however, conflicting evidence with assorted~     measures of socioeconomic status. Brazil is a country with enormous social contrasts, and~     deep inequality. We have a mixed origin of cultures and different economic and regional~     conditions. We believe that the perception and the impact that has Pelvic floor dysfunction~     in the quality of life of the woman must vary widely according to socioeconomic status~     (including household income, highest educational level, family income). There is to date no~     studies have correlated a criterion for classifying economic official in Brazil with the~     impact of quality of life (based in KHQ or PQOL) of women with urinary incontinence and~     pelvic organ prolapse.~   "
128061|NCT01891149|"~     This study is a cross-sectional study of 110 Malawian women to compare the ultrasonographic~     and hormonal characteristics of women and without obstetric fistula.~      Hypothesis #1: Women with obstetric fistula have a mean cervical length measurement that is~     at least 10 mm shorter than the mean cervical length measurement of similar women without~     obstetric fistula.~      Hypothesis #2: Evaluation of the hormonal and ultrasonographic characteristics of women with~     obstetric fistula will allow us to assess the cause of amenorrhea in these women.~   "
128062|NCT01891136|"~     This is a study to determine if peanut oral immunotherapy (OIT) would desensitize or tolerize~     peanut allergic patients to peanuts in order prevent peanut allergic reactions.~   "
128129|NCT01890265|"~     To evaluate the safety and tolerability of FG-3019 in subjects with IPF, and the efficacy of~     FG-3019 in slowing the loss of forced vital capacity (FVC) and the progression of IPF in~     these subjects.~   "
128064|NCT01891110|"~     Background:~      The presence of orthostatic hypotension (OH) as a consequence of blood volume redistribution~     during verticalisation in persons with spinal cord injury (SCI) is a common condition.~      Aims:~      To investigate the impact of three different types of electric stimulation (ES) (ES of the~     abdominal muscles versus ES of lower limb muscles versus simultaneously ES of abdominal and~     lower limb muscles versus control) on blood pressure stabilization and~     verticalisation-degrees between 0° and 70°. The hypothesis is, that the ES-induced~     contractions of the muscles cause a stabilisation respectively an increase of the blood~     pressure during the tilt-table test.~      Subjects:~      20 Women and men, at least 18 years of age, following an acute and traumatic SCI, with a~     lesion level above T6, an American Spinal Injury Association (AIS) Impairment Scale A,B or C~     and a diagnosis of OH (by tilt table test) were eligible for the study.~      Methods:~      Each patient underwent randomly three different types of ES sessions while being positioned~     on a tilt-table. The following sessions were planned:~      A) ES of the abdominal muscles B) ES of the lower limb muscles C) Combination of A and B D)~     Control session (=diagnostic session)~      Study type: Intervention Design: Prospective interventional study~   "
128065|NCT01891097|"~     This is a randomized controlled trial to evaluate the clinical efficacy of combined~     electro-acupuncture and auricular acupuncture for persistent Iinsomnia in the adult~     population in Hong Kong.~   "
128066|NCT01891084|"~     The purpose of this study is to investigate the potential benefits and risks of antipyretics~     use in naturally occurring influenza virus infections in humans.~   "
128067|NCT01891071|"~     Multiple sclerosis is a neurological disease that can affect lung function and cough~     efficacy. This pilot study will examine whether the lung volume recruitment technique can~     slow down the decline in lung function and cough.~   "
128068|NCT01891058|"~     Atrial fibrillation (AF) and atrial flutter (AFL) are cardiac rhythm problems where there is~     an irregular, rapid heart rate. Investigators plan to study Emergency Department (ED)~     patients with recent-onset episodes of AF or AFL (RAFF) where rapid heart rate requires~     urgent treatment to restore normal heart rhythm. RAFF is the most common rhythm disorder~     managed in the ED. Investigators recently showed that doctors use a wide variety of treatment~     approaches in Canadian EDs for RAFF. Also, the Canadian Cardiovascular Society Guidelines~     indicate that there have not been enough studies to know if the best treatment is to use an~     electrical shock (Shock Only) or drugs followed by shock (Drug-Shock). Investigators believe~     that Drug-Shock approach will be more effective and will help avoid an electric shock for~     many patients. Investigators also do not know if electrical shocks should be given with the~     electrode pads on the front (antero-lateral) or front and back (antero-posterior).~      Investigators intend to conduct 2 randomized protocols within one study (partial factorial~     design) in order to answer these two questions. 1. Will initial drug treatment followed by~     electrical shock if necessary (Drug-Shock) lead to more patients being converted to normal~     heart rhythm than a strategy of only electrical shock (Shock Only)? 2. Will the~     antero-posterior pad position be more effective than the antero-lateral position?~     Investigators plan to enroll 468 RAFF patients at 8 large Canadian EDs. Patients will be~     randomized to 1 of 2 arms for each of the two protocols. Investigators primary outcome will~     be conversion to normal heart rhythm. Other outcomes will include heart rhythm at discharge,~     need for hospital admission, length of stay in ED, adverse events, patient satisfaction, and~     14-day follow-up status.~      Investigator results will add important information about the best and safest ways to treat~     RAFF patients in Canadian EDs. Ultimately Investigators expect to see fewer patients admitted~     to hospital and more patients rapidly and safely returned to their normal activities.~   "
128069|NCT01891045|"~     Dropout represents one of the largest problems in substance abuse treatment. International~     and Nordic research show that only 20 - 40 % of substance abusers complete treatment as~     intended. At the same time, one of the most consistent factors of favourable post-treatment~     outcome is treatment completion. In spite of the serious and continuous challenge dropout~     represents the phenomena is not well understood and there is a need to explore more of the~     factors that influence dropout and how it can be counteracted. As also stated: …effective~     methods for reducing the problem of dropouts from treatment is one more area in need of~     further research (NOU 2003:4, s 77).~      For the general field of mental health one of the most important innovations involves~     providing therapists with patient feedback about their progress. The most well-established~     and widely researched feedback system is the Outcome Questionnaire (OQ-45.2). The system has~     been shown to improve treatment outcomes, including reduced treatment dropout and length of~     treatment, but the system is yet to be utilized with a substance abusing patient group. The~     aim of the present study is to examine the usefulness of OQ-45.2 with substance abusing~     patients.~   "
128070|NCT01891032|"~     Urinary Neutrophil gelatinase associated lipocalin (NGAL) has been recently reported to be~     related with the degree of acute kidney injury. We are trying to analyze whether it is~     related with the grade of acute kiney injury after partial nephrectomy and there is any~     difference between the kinds of surgery.~   "
128071|NCT01891019|"~     The objective of this study is to obtain information on the effectiveness of thalidomide in~     psoriasis.~   "
128072|NCT01891006|"~     The purpose of this study is to examine whether Negative Pressure Wound Therapy is an~     effective wound treatment compared to conventional wound treatment in the period of time from~     reoperation to re-suturing in women having surgical wound rupture after Caesarean Section.~   "
128073|NCT01890993|"~     This study is conducted in Europe. The aim of this study is to demonstrate the clinical~     effectiveness and safety of liraglutide and dipeptidyl peptidase-4 (DPP-4) inhibitor therapy~     in routine primary care in Europe.~   "
128074|NCT01890980|"~     The goal of this clinical research study is to learn if the Wilms Tumor-1 (WT1) vaccine, when~     given in combination with montanide and GM-CSF, can help to prevent or delay mesothelioma~     from coming back after surgery and treatment. The safety of this vaccine will also be tested.~      Montanide and GM-CSF are designed to cause white blood cells to grow, which may help to~     increase the immune response.~      WT1 is a protein in cancer cells that regulates gene expression and causes cell growth.~     Mesothelioma tumors usually have high levels of WT1. The WT1 vaccine is designed to cause the~     increased immune response created by other drug combinations (like montanide and GM-CSF) to~     be directed at mesothelioma.~   "
128075|NCT01890967|"~     This study is designed to define the amount and duration of cholesterol lowering and to~     assess the safety and tolerability of different dose regimens of LY3015014 in participants~     with high cholesterol. The study will also investigate how the body processes the drug and~     how the drug affects the body. Participants will remain on a stable diet and will continue~     taking cholesterol-lowering medications (statins with or without ezetimibe). After signing~     the informed consent document, the participant will complete a screening/run-in period that~     will last at most 8 weeks. Then, the treatment period will last approximately 16 weeks. After~     the treatment period, the participants will complete a follow-up period lasting approximately~     8 weeks for a total study duration ranging from approximately 25 to 32 weeks.~   "
128079|NCT01890915|"~     The deleterious effects of hyperthermia are well appreciated in able-bodied persons. However,~     the consequences of impaired regulation of normal body temperature on cognitive performance~     of persons with tetraplegia is not known. This study will provide the preliminary findings~     necessary for future work to design and explore physical and medical interventions to improve~     temperature regulation in those with tetraplegia with the goal of improved clinical care,~     health, and quality of life.~      The proposed study consists of 1 visit during which 20 subjects (10 with tetraplegia, 10~     controls) will be exposed to 81°F for 40 minutes and then 95° F for up to 2 hours.~     Physiological as well as psychological processes will be monitored in all subjects during the~     study for safety and to determine differences in responses to exposure to hot ambient~     temperatures~   "
128080|NCT01890902|"~     The primary objective of the study is to assess analgesic efficacy of Impracor (Ketoprofen~     10% Cream) compared to placebo for acute pain associated with OA flare of the knee.~   "
128081|NCT01890889|"~     The purpose of this study is to evaluate the effectiveness of a food-source nutrient~     containing bitter orange by comparing changes 45 blood chemistries and self-reported quality~     of life.~   "
128082|NCT01890876|"~     Concentric (CE) and eccentric (EE) exercises may differently affect glucose metabolism which~     may be additionally modified when exercises are performed in hypoxia, e.g. at moderate (1500~     - 2500 m) or high (2500 - 3500 m) altitudes. However, data on the effects of glucose~     metabolism due to CE and EE in hypoxia are scarce but would be of utmost importance~     considering the increasing number of persons suffering from impaired glucose tolerance or~     diabetes and the unique opportunities provided by the mountainous regions of the Alps to~     perform CE (e.g. uphill hiking) and EE (downhill hiking, downhill skiing) at altitude between~     1500 - 3500 m. Metabolic responses to exercise may be largely mediated by interleukin 6~     (IL-6), which is predominantly derived from the contracting limbs and may support the~     maintenance of metabolic homeostasis during exercise. In addition, IL-6 is elevated with~     acute and chronic altitude exposure at least partly mediated via adrenergic stimulation.~     Thus, the type of exercise as well as hypoxia may contribute to IL-6 elevations and~     differences in serum IL-6 concentrations might help to explain distinctions between responses~     of glucose metabolism to CE and EE at low and moderate to high altitude.~      32 male subjects suffering from pre-diabetes will be randomly assigned to a downhill (EE) or~     uphill (CE) walking group performing 9 sessions at low altitude (860 - 1360 m) and 9 sessions~     at moderate to high altitude (2000 - 2500 m). Between normoxic and hypoxic condition will be~     a break of approximately 12 month. Measurements of glucose metabolism, IL-6 plasma~     concentration will be performed pre, mid (day 5) and post intervention. Moreover~     anthropometric, strength and exercise capacity characteristics will be performed pre and post~     intervention.~      We hypothesize that EE in hypoxia is more effective in the modulation of glycemic control in~     pre-diabetic men than CE in hypoxia as well as EE and CE in normoxia. It is suggested that~     effects on glucose metabolism are associated with changes in plasma IL-6 concentrations. EE~     in hypoxia is expected to result in a more persistent rise of plasma IL-6 concentration than~     CE in hypoxia and in normoxia and to a more pronounced rise in plasma IL-6 than EE in~     normoxia.~   "
128083|NCT01890863|"~     This study will compare the pharmacokinetic (PK) of Fluticasone Propionate/Salmeterol~     combination (FSC) 100/50 micrograms (mcg) delivered via the capsule-based inhaler (Rdpi)~     relative to FSC 100/50 mcg delivered via the multi-dose dry powder inhaler (Ddpi) to~     establish whether the Rdpi inhaler has exposure (in terms of fluticasone propionate area~     under time concentration curve [AUC] and Salmeterol maximum concentration [Cmax]) no greater~     than 1.2500 compared to the Ddpi, sufficient to allow progression to Phase 3. This study will~     enroll 36 healthy adult male and female subjects and each subject will be allocated to one of~     two sequences and will participate in four treatment periods, receiving each of the~     treatments twice.~   "
128084|NCT01890850|"~     This study aims to estimate the risk factors associated with pertussis/whopping cough~     infection among infants less than one year of age in a United States (U.S.) commercially~     insured population. The study will utilize a large research data base associated with a~     geographically diverse U.S. health plan not limited by one geographic area or disease~     outbreak to evaluate pertussis in infants between 2005 and 2010. Healthcare costs and~     utilization among infants with a reported diagnosis of pertussis/whooping cough stratified by~     the number of DTaP vaccinations received prior to infection will also be reported.~   "
128085|NCT01890837|"~     The purpose of this study is to compare the effects of 5g of Daikenchuto (TU-100) three times~     per day (Daikenchuto [TU-100] is a botanical agent that modulates gastrointestinal nerves),~     and placebo on rectal sensation (sensation ratings of urgency to defecate and sensation~     threshold for pain) in response to rectal balloon distension by barostat in patients with~     IBS.~   "
128086|NCT01890824|"~     Following chemotherapy, breast cancer patients primarily gain fat mass and lose muscle mass.~     Both depletion of muscle and an increase of fat mass in breast cancer patients are related to~     short survival, and decreased skeletal muscle mass and function may result in fatigue and~     inactivity, which contributes to fat mass changes and can be responsible for chemo-toxicity~     and increased mortality. The purpose of this study is to provide detailed insight in~     chemotherapy related changes in lipid metabolism and gut digestion and absorption of fat in~     breast cancer patients compared to matched healthy controls. This will provide required~     information that is necessary to implement new strategies to develop optimal nutritional~     regimen in breast cancer patients. The hypothesis is that chemotherapy in breast cancer is~     related to altered gut function and absorption and to increases in fat synthesis that lead to~     fat accumulation. In addition, we will examine the effect of cancer, chemotherapy, and gender~     by comparing fat digestion/absorption and fat metabolism of the breast cancer before and~     after chemotherapy, to aged matched healthy female and male controls.~   "
128087|NCT01890811|"~     Weight loss commonly occurs in patients with chronic kidney disease (CKD), negatively~     influencing their quality of life, treatment response and survival. Loss of muscle protein is~     generally a central component of weight loss in CKD patients but patients also have~     reductions in fat mass and bone density, independent of the severity of the disease state.~     Attempts to reverse weight and muscle loss in CKD and improve nutritional status by~     nutritional supplementation have been unsuccessful and there are currently no approved~     therapies.~      Purpose of this study is to provide detailed insight in disease related gut function by~     obtaining information on gut permeability, digestion and absorption of glucose, fat and~     protein in CKD patients compared to matched healthy controls. Additionally, to examine~     whether protein and amino acid metabolism is disturbed in CKD patients compared to healthy~     controls. This will provide required information that will lead to implement new strategies~     to develop optimal nutritional regimen in order to enhance nutritional status, quality of~     life and survival in relation to kidney disease.~   "
128141|NCT01890109|"~     The primary objective of this study was to evaluate the frequency of moderate to severe daily~     hot flashes 4 weeks after a single dose of erenumab (AMG 334) in women with hot flashes~     associated with menopause.~   "
128090|NCT01890772|"~     This study is for people who have been diagnosed with chronic hepatitis C, specifically those~     who have a certain type of the virus, genotype 1, and who have not yet received treatment for~     hepatitis C. This pilot study is designed to test whether the addition of vitamin D, to the~     three drugs (Incivek (telaprevir), Pegasys (peginterferon alfa-2a), and ribavirin) that are~     approved by the Food and Drug Administration (FDA) for the treatment of hepatitis C, can help~     eliminate the HCV from the body. Currently, doctors are unsure if the addition of vitamin D~     to prescribed hepatitis C therapy will have any effects on how the body clears the virus.~      Once enrolled, participants will be randomly assigned (like flipping a coin) to receive~     telaprevir + peginterferon alfa-2a + ribavirin + vitamin D3 (treatment group) or telaprevir +~     peginterferon alfa-2a + ribavirin (control group). A total of 80 participants, of all~     races/ethnicities, will be included in this study, at 5 to 10 VA hospital study sites (10 -~     20 participants/site).~      Participants assigned to the treatment group will begin a lead-in phase where they will~     receive 5,000 IU of vitamin D3 per day. Every two weeks during the lead-in phase,~     participants will be tested to determine the Vitamin D level in their blood, as well as other~     tests, including HCV RNA (to determine the amount of virus present) and calcium levels. Once~     an adequate level of Vitamin D is detected in participants' blood, participants will begin~     treatment with telaprevir + peginterferon alfa-2a + ribavirin + vitamin D3 (15,000 IU/week)~     for 12 weeks.~      Participants randomized to the control group will immediately begin treatment with telaprevir~     + peginterferon alfa-2a + ribavirin for 12 weeks. At the end of Week 12 the participants'~     involvement in the study will be complete.~      Adverse events and effects of vitamin D3 will be obtained by assessing participants' medical~     history, physical examination, and blood tests at clinic visits. HCV RNA will be assessed at~     Screening, Day 1, Week 2, 4, 8 and 12.~   "
128091|NCT01890759|"~     The purpose of this study is to assess the immunogenicity and safety of Menactra® vaccine~     given as a two-dose series in infants and toddlers.~      Primary Objectives:~        -  To assess the seroprotection rate (percentage of subjects with a serum bactericidal~          assay using human complement [SBA-HC] titer ≥ 1:8) 28 days after the second of 2 doses~          of Menactra® administered 3 to 6 months apart.~      Secondary Objectives:~        -  To assess the immune responses to meningococcal antigens (serogroups A, C, Y, and W-135)~          28 days following the second vaccination with Menactra® using SBA-HC and SBA-BR titers.~        -  To assess the safety profile of Menactra® after each and any vaccination.~   "
128092|NCT01890746|"~     The purpose of this randomized, blinded, placebo-controlled study is to provide clinical~     safety and exploratory efficacy data on the use of Eltrombopag in adult subjects with Acute~     Myeloid Leukemia (AML) receiving standard induction chemotherapy with daunorubicin plus~     cytarabine. These safety data are considered necessary to further development of Eltrombopag~     in both adult and paediatric patients suffering from malignant diseases with secondary~     thrombocytopenia. A minimum of 120 evaluable subjects with newly diagnosed with AML will be~     stratified by antecedent malignant hematologic disorder and age.~   "
128093|NCT01890733|"~     This is a post-marketing study to further assess the safety and effectiveness of the InSpace™~     device implantation in comparison to surgical repair of full thickness Massive Rotator Cuff~     Tear .~      The effectiveness will be assessed by comparing the scores of the ASES, Constant and Quick~     DASH outcome questionnaires with respect to pain reduction, improvement of activity of daily~     living(ADL) and improvement of range of motion (ROM).~   "
128094|NCT01890720|"~     The purpose of this study is to examine whether obese women (BMI >= 30) who give birth by~     caesarean section have a reduced incidence of wound infection and dehiscence when incisional~     Negative Pressure Wound Therapy is applied prophylactically following caesarean section.~   "
128095|NCT01890707|"~     The use of deep sedation may improve the quality of recovery of patients undergoing minor~     gynecologic procedures. These patients may also have shorter hospital stays and potentially~     lower healthcare costs. Additionally, the use of deep sedation for second trimester pregnancy~     termination may be associated with less bleeding, a smaller decrease in perioperative~     hemoglobin and better quality of recovery.~   "
128096|NCT01890694|"~     Hyponatremia is a condition in which there is a low sodium level in the blood. Individuals~     with cirrhosis may develop low blood sodium as a complication of their liver disease. In~     these patients, the presence of low blood sodium may exacerbate other complications such as~     encephalopathy, resulting in confusion, drowsiness, or coma. It may also affect the ability~     of the body to fight infection. In certain cases, cirrhotic patients may be hospitalized for~     the treatment of their low blood sodium.~      The drug tolvaptan is currently FDA approved for the treatment of hyponatremia in patients~     with cirrhosis. Although it has been shown to increase the sodium level, the clinical trials~     that led to its approval did not otherwise assess clinical benefit of the drug.~      This study is designed to determine whether patients with cirrhosis derive a clinical benefit~     when they receive tolvaptan for the treatment of hyponatremia within 2 days of admission.~     Specifically, whether it is associated with shortened length of stay and improvement in other~     complications of cirrhosis.~   "
128097|NCT01890681|"~     This study will evaluate the efficacy of a six-month-long intervention in improving the~     nutrition and physical activity environments of child care centers serving racially and~     ethnically diverse children from birth to two years of age and the family home. The focus of~     the intervention will be on center policies, provider and parent practices, and children's~     home environments that influence dietary intake and physical activity. Outcomes for this~     study include child dietary intake, physical activity, and two adiposity measures:~     weight-for-length and skinfold thicknesses. Child care centers and children's home~     environments will also be measured to evaluate how well they support healthy behaviors.~   "
128098|NCT01890668|"~     Breastfeeding is one of the prime factors of long-term health protection in newborns, for~     nutritional, immunological and developmental reasons. In France there is a wide~     inter-regional variability of breastfeeding rates at discharge. This variability associates~     different factors involving both, mothers, birth conditions, newborns and mother-child~     couple. Some approaches, including osteopathy, aim to support early breastfeeding~     difficulties. As many others non-conventional medicines, there is a huge and growing interest~     for this alternative therapy and a spontaneous recourse in the first months of life.~     Nevertheless, neither efficacy nor the benefits have been studied. Thus, our objective is to~     evaluate for the first time in France, in a randomized, double-blinded design, the efficacy~     of early osteopathic manipulative treatment (OMT), in suboptimal breastfeeding behaviour~     healthy newborns.~      128 couples mother-child will be randomized in two groups: with or without osteopathic~     intervention on the newborn.~   "
128099|NCT01890655|"~     To evaluate the long-term safety and tolerability of MT-1303 in subjects with relapsing~     remitting multiple sclerosis (RRMS).~   "
128100|NCT01890642|"~     This study looks at the use of Jet Injection Lidocaine (J tip) for pain during blood draws in~     children ages 6 and younger. The investigators will use video observation of patients to~     asses their pain during lab draws using either 1) Jet Injected lidocaine ( J tip) 2) Pain~     Ease spray 3) Pain Ease spray plus the J tip noise.~   "
128104|NCT01890590|"~     CyberKnife Based Radiosurgery is a way to deliver large doses of radiation very accurately to~     a tumor. The ability of this technology to minimize radiation dose to organs adjacent to the~     target tumor allows a high dose to be delivered to the tumor, thus potentially increasing the~     efficacy of radiation treatment. Currently, radiosurgery is commonly used for brain~     metastases, Stage I lung cancer, spine tumors, and localized prostate cancer. The purpose of~     this protocol is to evaluate the role of Radiosurgery for the treatment of clinically~     localized primary renal cell carcinoma.~   "
128105|NCT01890577|"~     An observational study to describe the treatment of anaemia in patients with chronic kidney~     disease, who are receiving dialysis treatment at selected study centres in South Africa.~   "
128106|NCT01890564|"~     During minimally invasive surgery, a pneumoperitoneum is created to facilitate surgical~     visualization. Although effective in facilitating the procedure, there are respiratory~     consequences of the pneumoperitoneum, which significantly increases intra-abdominal pressure~     (IAP) up to 20 cmH2O. The increased IAP can decrease functional residual capacity and~     increase closing capacity resulting in increased resistance, decreased compliance, and~     increased ventilation-perfusion mismatch. In a randomized, cross-over design, this study will~     evaluate in sequential order, 3 modes of ventilation during laparoscopic bariatric surgery to~     determine which is better able to support oxygenation and ventilation while limiting the peak~     inflating pressure (PIP).~   "
128107|NCT01890551|"~     Purpose: The impact of kinematic-MRI (KINE-MRI) in the patellofemoral instability and~     anterior knee pain of the adolescents is rarely reported.Interest was to evaluate the~     patellofemoral joint biomechanics with KINE-MRI in adolescents with affected and unaffected~     knees in a case-control study.Methods: KINE-MRI was performed in 29 adolescents (affected~     knee group, AKG, n=29 and n=26 unaffected knee group, UAKG, n=26) aged 11-16 years with~     unilateral patellofemoral instability. For the control group invvestigators enrolled ten~     healthy age- and sex-matched volunteers (healthy knee group, HKG, n=19 ).The study~     parameters, Bisect Offset (BSO), Lateral Patellar Displacement (LPD), Patellar Tilt Angle~     (PTA), Sulcus Angle and Insall-Salvati ratio at 0, 10, 20 and 30 degrees of~     flexion-extension, were measured for the AKG patients (n=29), and UAKG patients (n=26) and~     the HKG subjects (n=19). Results: In a comparison between the AKG patients and the HKG~     subjects there was a significant difference in the BSO-ratio, LPD-test and PTA-test. In these~     parameters the difference between the AKG patients and the HKG subjects progressively~     increased towards the full extension of the knee. In the AKG and UAKG patients BSO-ratio at 0~     degree ranged between 0.5 and 1.2 in both groups, whereas the BSO-ratio in the HKG subjects~     ranged between 0.33 and 0.75 (P < .001). At the zero degree the LPD-test ranged between 0 and~     10 mm in the AKG patients and between 0 and 35 mm in the UAKG patients, whereas the lateral~     displacement-test ranged between 0 and 5 mm in the HKG subjects (P = .003). Patellar tilt~     angle-test ranged between -30 and 20 degrees in the AKG patients and between -30 and 24~     degrees in the UAKG patients and in the HKG subjects the PTA-test ranged between 10 and 24~     degrees (P < .001).Conclusion: The KINE-MRI could be a feasible method for the evaluation of~     patellar tracking in adolescents.~   "
128108|NCT01890538|"~     This study aims to investigate efficacy of two different intravenous drugs (dimenhydrinate~     and piracetam) in the symptomatic management of peripheral vertigo.~      The patients will be randomized in two groups according to symptomatic treatment modalities:~     Dimenhydrinate (100 mg) and piracetam (2 g) will be given in 100 cc normal saline in 30~     minutes. Each patient will be asked if her/his vertigo symptoms resolved or not, according to~     a numeric rating scale (0=no vertigo, 10=worst possible vertigo). The patient will be rate~     the intensity of symptoms in the following times:~        -  Numeric rating scale (1 to 10): Admission~        -  Numeric rating scale (1 to 10): After the study drug (No ambulation)*~        -  Numeric rating scale (1 to 10): After the study drug (Ambulation)*~             -  Ambulation refers to head movements or walking in the room, if applicable.~   "
128109|NCT01890525|"~     The purpose of this study is to compare different methods of collecting the amount of~     radiation exposure patients receive in a clinical study. As part of the PROMISE study, the~     Duke Clinical Research Institute Outcomes and Follow-up Group will be contacting patients~     every six months to ask if they had any heart procedures or testing. This information will be~     used to estimate the amount of radiation that they may have received from heart testing being~     studied in this study, PROMISE-SAFER. Patients will be asked to collect information about~     each heart testing they receive during the time that they are enrolled in the PROMISE study.~     At the conclusion of the study, we will be able to determine which method was most accurate~     in collecting the amount of radiation exposure for this clinical study. Through this study we~     hope to develop an improved methodology to estimate cumulative radiation exposure from~     cardiac imaging. Comprehensive measurement of cumulative radiation exposure to patients may~     be critically important to minimize potential harm in future studies and in clinical~     practice.~   "
128110|NCT01890512|"~     The INFINITE MRI Study is a prospective, non-randomized, multicenter, single arm study aimed~     at collecting data on ImageReady™ MR Conditional Pacing System (consisting of an INGENIO™ MRI~     or ADVANTIO™ MRI pacemaker with FINELINE™ II Sterox or FINELINE™ II Sterox EZ endocardial~     pacing lead(s)) when used in the Magnetic Resonance Imaging environment under the labeled~     Conditions of Use.~   "
128111|NCT01890499|"~     Prospective randomized controlled trial investigating commencement of low residue diet versus~     clear feeds on postoperative day one following elective colorectal surgery, with regards to~     patient tolerability, incidence of nausea and/or vomiting, and postoperative length of~     hospitalization stay.~   "
128112|NCT01890486|"~     To provide the IRB approved mechanism for the prospective collection, analysis and reporting~     of data on patients who are undergoing either an autologous or allogeneic hematopoietic stem~     cell transplant for a disease in which a research question is not being addressed and for~     which peer reviewed, published data have demonstrated efficacy for this treatment approach.~   "
128113|NCT01890473|"~     The primary purpose of the protocol is to describe the pharmacokinetics of a single dose of~     Abatacept 125 mg in Rheumatoid Arthritis patients delivered via the autoinjector device or~     the approved prefilled syringe.~   "
128114|NCT01890460|"~     The purpose of the study is to compare ultrasound measurements of the liver obtained prior to~     surgery on the skin to measurements obtained during surgery directly on the diseased liver.~     The objective is to determine if ultrasounds of the liver on the skin can provide accurate~     measurements of disease of the liver to provide an alternative option to liver biopsies.~   "
128115|NCT01890447|"~     This study aims to establish an effective method to inform parents or close relatives of~     newborns about the risk of pertussis transmission to newborns and the advantages offered by~     the cocooning strategy (vaccinating those who are in close contact with the newborn) by~     assessing the factors that affect the parents' decision-making to accept pertussis~     immunisation.~   "
128610|NCT01884012|"~     In this randomized-controlled, cross-over trial the investigators test the effect of~     long-term oxygen therapy (> 16h/day) given for 5 weeks with a wash-out period between phases~     of 2 weeks on exercise performance and quality of life and many physiological parameters in~     patients with pulmonary arterial and chronic thromboembolic pulmonary hypertension.~   "
128116|NCT01890434|"~     Subjects being evaluated for suspected or known Coronary artery Disease (CAD) based on signs~     and/or symptoms, will be invited to participate in the study. The duration for a subject in~     the study may range from 2 days to 4-6 weeks. One to four visits to the study doctor will be~     required.~      The primary objective of this study is to demonstrate that sensitivity and specificity of~     gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) exceed pre-specified minimum~     performance thresholds of 60% and 55%, respectively, and to show superior sensitivity over~     unenhanced wall motion CMRI at vasodilator rest/stress for the detection of significant CAD.~     The CMR images acquired with a uniform imaging acquisition software will be evaluated either~     against the results from routine clinical Coronary Angiography (CA) or Computed Tomography~     Angiography (CTA), which are the standard of reference.~      CMRI and CA/CTA images will be collected for an independent image review (blinded read).~   "
128117|NCT01890421|"~     Participants being evaluated for suspected or known Coronary artery Disease (CAD) based on~     signs and/or symptoms, will be invited to participate in the study. The duration for a~     participant in the study may range from 2 days to 4-6 weeks. One to four visits to the study~     doctor will be required.~      This study will investigate the diagnostic results of gadobutrol-enhanced Cardiac Magnetic~     Resonance Imaging (CMRI) images regarding the detection (sensitivity) and exclusion~     (specificity) of coronary artery disease utilizing a uniform image acquisition software. The~     CMR images will be tested either against the results from routine clinical Coronary~     Angiography (CA) or those from Computed Tomography Angiography (CTA), which is used as the~     standard of reference. The CA/CTA may have been performed up to 4 weeks prior to enrollment~     or be scheduled up to 4/6 weeks after the study.~      CMRI and CA/CTA images will be collected for an independent image review (blinded read).~   "
128118|NCT01890408|"~     Intravenous morphine Patient-Controlled analgesia is gold standard on post - operative liver~     resection. But, opioids tend to be ineffective for pain that is associated with movement and~     have significant short-term side effects including nausea, vomiting, sedation, pruritus,~     constipation, urinary, retention, and respiratory depression, which are factors that often~     hinder a patient's recovery. Prospective randomized trials has found continuous wound~     catheter analgesia as an accepted alternative to IV morphine PCA.~      The researchers will investigate whether ropivacaine, administered through a wound catheter~     placed by the surgeon, will reduce morbidity and provide a better recovery.~   "
128119|NCT01890395|"~     To identify patients who may be predisposed for developing MOF (multiple organ failure)by the~     sampling of blood.~   "
128120|NCT01890382|"~     The combination of protein and resistance exercise seems to be one of the most effective~     tools to counteract sarcopenia. Randomized controlled trials supporting this possibility are~     still scarce. These series of clinical trials aim to investigate the therapeutic role of~     protein ingestion combined with resistance training in frail elderly participants. These~     studies will mainly address the following research questions: Is the protein source (i.e.,~     whey versus soy) a factor in inducing a differential anabolic response? Does dietary protein~     consumption dictate a whey/training-induced anabolic response? Does leucine supplementation~     promote anabolic response? Does co-supplementation of creatine and whey protein foster an~     anabolic response?~   "
128121|NCT01890369|"~     The investigators plan to explore the ability of amino acids, the building blocks of proteins~     in our bodies and in the food we eat, to stimulate muscles to grow and stay strong. The~     investigators will investigate how rapidly after one meal the human body is ready to make use~     of a second meal and look at the molecular mechanisms underlying this. The investigators will~     look at these phenomena in older men as this group is known to be subject to a gradual loss~     of muscle mass and strength.~   "
128122|NCT01890356|"~     Transcranial electrical stimulation (TES) techniques offer a novel treatment approach for~     depression and have shown promising efficacy. However, there is no published data to date on~     their effectiveness as a maintenance treatment. This study will investigate ways of using TES~     as a maintenance treatment to prevent relapse in depression.~   "
128123|NCT01890343|"~     Study 18F-AV-45-010 is designed to evaluate the cerebral uptake of florbetapir 18F as~     measured by PET imaging in frontotemporal disorder (FTD) in comparison to cognitively normal~     volunteers and subjects with Alzheimer's disease (AD).~   "
128124|NCT01890330|"~     MetS is an early stage of CVD and is an appropriate target for dietary interventions. MetS is~     a clustering of risk factors (abdominal obesity, elevated serum triglycerides, low~     HDL-cholesterol, hypertension, elevated fasting blood glucose) accompanied by low grade~     chronic inflammation, hepatic steatosis (fatty liver) and reduced vascular function.~      This study will investigate the effect of a 12 week intervention with canola oil versus the~     typical fat mixture in the Western diet on blood lipids, blood vessel function and MetS~     parameters. CVD risk will be assessed based on the profile of lipids and other factors in the~     blood as well using specialized equipment for non-invasive monitoring of blood vessel~     function.~   "
128125|NCT01890317|"~     Prospective, randomized, single-center, controlled, open-label Pilot-study to investigate~     whether induction of mild hypothermia in addition to primary percutaneous coronary~     intervention and optimal medical therapy in myocardial infarction complicated by cardiogenic~     shock improves cardiac power index after 24 h.~   "
128126|NCT01890304|"~     To identify the changes in the brain following repeated sports-related concussion in men's~     football, women's soccer, and women's lacrosse college athletes by reviewing the findings of~     MRI studies that look at the structure of the brain and the appearance of the white matter at~     baseline, during the acute phase of a concussive injury, and upon completion of collegiate~     athletic play and correlate these findings with standard clinical measures.~   "
128127|NCT01890291|"~     To observation that long term follow-up study of 'Immuncell-LC groups' and 'Non-treatment~     groups' in patient undergo curative resection (PEIT, RFA or Operation) for hepatocellular~     carcinoma in Korea~   "
128128|NCT01890278|"~     In this study the patient will receive either whole brain radiation therapy given by~     intensity modulated radiation therapy (IMRT) or standard conventional radiation. In IMRT~     therapy radiation dose to the parts of the brain that do not contain tumors is reduced. This~     study will look to see if this approach results in less hair loss or fewer memory Problems,~     as compared to the standard technique. The study will also look at the effectiveness of both~     techniques in controlling the growth of the tumor.~   "
128130|NCT01890252|"~     The Hyper-CL™ lenses are indicated for therapeutic use as a bandage to protect the corneal~     surface and to relieve corneal pain in the treatment of acute or chronic ocular pathologies,~     such as bullous keratopathy, corneal erosions, entropion, corneal edema, and corneal~     dystrophies as well as post-surgical conditions resulting from cataract extraction and~     corneal surgery. The lenses may be prescribed for daily wear with removal for cleaning and~     disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care~     professional.~      In addition Hyper-CL™ contact lenses can also provide optical correction during healing if~     required.~      Prospective open-label, randomized, crossover clinical study To evaluate the safety and~     efficacy of the Hyper-CL™ lens in subjects suffering from corneal edema.~      This study is designed to evaluate the efficacy of the Hyper-CL™ lens contact lens on corneal~     edema thickness as compared with salt solution treatment only in subjects suffering from~     corneal edema.~      Treatment with the Hyper-CL™ lens may result with greater reduction in edema thickness as~     compared with treatment with salt solution only in subjects suffering from corneal edema.~      Men and women suffering from a decrease in vision due to corneal edema that meet the~     inclusion/exclusion criteria and provide written Informed Consent will be enrolled in the~     study.~      A total of 25 subjects will be enrolled. Each subject will be treated with:~        -  Treatment A: Hyper-CL™ lens only (7 days)~        -  Treatment B: Hyper-CL™ lens + salt solution (7 days)~        -  Treatment C: salt solution only (7 days) One week (7 days) of washout without any~          treatment will be between treatments. Subject will be equally allocated (with a~          1:1:1:1:1:1 ratio) to one of the following 6 crossover regimen based on a randomization~          scheme with blocks stratified by center: C-A-B; B-C-A; A-B-C; C-B-A; B-A-C; A-C-B.~      Up to 2 centers will participate in this study. Each subject will be followed from baseline~     to 42 days. All Subjects will come for a clinic visit at 7, 14, 21, 28, 35 and 42 days post~     first treatment.~      Completion of active enrolment is anticipated to last approximately 6 months. The primary end~     point will be achieved when the final study subject has completed 42 day follow-up.~   "
128131|NCT01890239|"~     BACKGROUND Demographic trends coupled with a rise in chronic diseases mean that the~     population of patients requiring palliative and end-of-life care is ageing. Due to the ageing~     population palliative care for older people has been identified as one of the worldwide~     public health priorities. A majority of elderly patients die in hospital. Studies from the~     United Kingdom and other countries have shown that many older persons dying in hospital~     experience suboptimal care. The Care Programme for the Last Days of Life has been developed~     to improve the quality of end-of-life care in acute geriatric hospital wards. The programme~     is based on existing end-of-life care programmes but modeled to the acute geriatric care~     setting. There is a lack of evidence of the effectiveness of end-of-life care programmes and~     the effects that may be achieved in patients dying in an acute geriatric hospital setting are~     unknown. The aim of this study is to evaluate the effectiveness of the Care Programme for the~     Last Days of Life in improving the quality of care and quality of life during the last 48~     hours of life of patients dying in acute geriatric hospital wards in Flanders as compared to~     usual care.~      METHODS In order to contribute substantially to the increase of evidence for the effect of~     the Care Programme for the Last Days of Life in patients dying in acute geriatric hospital~     wards, a cluster randomized controlled trial will be conducted. Ten hospitals with one or~     more acute geriatric wards will conduct a one-year baseline assessment during which care will~     be provided as usual. For each patient dying in the ward, a questionnaire will be filled in~     by a nurse, a physician and a family carer. At the end of the baseline assessment hospitals~     will be randomized to receive intervention (implementation of the Care Programme) or no~     intervention. Subsequently, the Care Programme will be implemented in the intervention~     hospitals over a six-month period. A one-year post-intervention assessment will be performed~     immediately after the baseline assessment in the control hospitals and after the~     implementation period in the intervention hospitals. Primary outcomes are symptom frequency~     and symptom burden of patients in the last 48 hours of life.~      DISCUSSION This will be the first cluster randomized controlled trial to evaluate the effect~     of the Care Programme for the Last Days of Life for the acute geriatric hospital setting. The~     results will enable us to evaluate whether implementation of the Care Programme has positive~     effects on end-of-life care during the last days of life in this patient population and which~     components of the Care Programme contribute to improving the quality of end-of-life care.~   "
128132|NCT01890226|"~     Poor quality of medical care is a major contributor to excess medical morbidity and premature~     mortality in persons with serious mental illnesses (SMI). To address this problem, community~     mental health providers are increasingly partnering with safety net medical providers to~     develop behavioral health homes, integrated clinics in which persons with SMI receive~     coordinated medical and mental health care. However, behavioral health homes have faced~     logistical and privacy challenges in integrating electronic medical records across~     organizations.~      This application proposes to develop and test a mobile Personal Health Record (mPHR) to~     overcome this problem while more fully engaging patients in their health care. The study will~     develop, test, and disseminate the mPHR. The investigators will develop the app building on~     experience and preliminary data from a PC-based PHR project, and link it to the medical and~     mental health EHR in a behavioral health home. Next, the investigators will conduct a~     randomized trial of the mPHR in 300 subjects randomized to the mPHR or usual care.~   "
128133|NCT01890213|"~     This is a pilot study to evaluate the safety of a vaccine that consists of an alphavirus~     replicon (VRP) encoding the protein (CEA) that has been found to be associated with cancers~     such as colon cancer in patients that have stage III colon cancer. We will also evaluate the~     patient immune response to the vaccine.~   "
128134|NCT01890200|"~     This is a randomized, double blind, multi-center, placebo controlled, three parallel arms,~     Phase IIb/III clinical study to evaluate the effects of adding a TCM-700C with a low or high~     dose onto the combination treatment (PegIFN plus RBV) for subjects with naive genotype 1 HCV~     infection.~      This will be demonstrated by a higher sustained virologic response rate, defined as the~     absence of detectable HCV RNA 24 weeks after the termination of combination treatment,~     compared with the placebo add-on.~   "
128135|NCT01890187|"~     The objective of this study is to determine the repeatability and reproducibility of the~     Cirrus HD-OCT measurement of illumination areas under the retinal pigment epithelium (RPE).~   "
128136|NCT01890174|"~     The objective of this study is to determine the repeatability and reproducibility of the~     Cirrus HD-OCT measurements of drusen area and volume.~   "
128137|NCT01890161|"~     This is the first study in human patients with asthma that the sponsor is conducting in order~     to evaluate if there are signals that the investigational medication, AXP1275, may be a safe~     and effective treatment for asthma. The results of this study may help the sponsor to design~     additional studies.~   "
128138|NCT01890148|"~     Distribution of neutrophils in bronchial mucosal tissue in asthma patients before and after 4~     wk treatment with AZD 5069~   "
128139|NCT01890135|"~     Peripheral artery disease (PAD) is a major complication of atherosclerosis when blockages in~     the arteries to leg reduce blood flow and one of the resulting problems is termed~     intermittent claudication (IC). IC is leg pain with walking that is relieved with rest and IC~     is the most frequent clinical manifestation of PAD and it effects millions of Americans. The~     number of patients with, and the health care costs of, PAD will increase as the prevalence of~     PAD is associated with advancing age, diabetes, and smoking. Zibotentan (ZD4054) is an~     endothelin receptor A (ETA) blocker that undergone extensive human testing and has been shown~     to be safe in several patient population. There is ample evidence to suggest that an ETA~     blocker could improve blood flow to the legs in patients with PAD. In a study that will be~     funded by the National Institute of Health, the investigators will test the ability of this~     medication to allow better blood flow to the legs of patients with PAD. In patients with IC,~     the investigators will test the ability of ZD4054 to improve leg blood flow using a~     non-invasive imaging technique. In parallel the study will test for the ability of patients~     with leg pain to walk further and feel better.~   "
128140|NCT01890122|"~     The purpose of this study is to evaluate the efficacy and safety of alogliptin and metformin~     fixed-dose combination (FDC) as compared with alogliptin alone or metformin alone on Type 2~     Diabetes Mellitus (T2DM).~   "
128142|NCT01890096|"~     A single high dose rate brachytherapy (HDR) treatment combined with a short course of~     external beam radiotherapy (EBRT) is a highly effective and well tolerated treatment for men~     with intermediate risk prostate cancer. High cancer control rates have also been reported~     with HDR used on its own, without the EBRT. The challenge has been to determine what HDR dose~     to use with a move towards one or two fractions by several investigators. These schedules are~     reported to be well tolerated in the short term, but with little long term data. The~     objective of this study is to investigate HDR monotherapy given as either one fraction of 19~     Gy or two fractions of 13.5 Gy in a randomized phase II clinical trial. The primary endpoint~     is patient reported toxicity and health related quality of life at 1 year, and efficacy data~     will be also be analyzed. Sample size for the study is 174 patients, which we expect to~     accrue within 18 months.~   "
128143|NCT01890083|"~     Interferon-alpha (IFN-α) is an efficacious treatment for Hepatitis C (HPC); however, IFN-α~     treatment results in a significant increase in depressive symptoms. The aim of this project~     is to compare two health interventions (exercise vs. health education) to prevent depression~     in HPC patients receiving IFN-α. Participants will be recruited from the Clinical Center for~     Liver Diseases at UT-Southwestern and randomized to 26 weeks of either: aerobic exercise or a~     health education control group.~   "
128144|NCT01890070|"~     The present protocol is designed to conduct nutrigenomic and nutrigenetic studies on foods~     conforming to the Mediterranean diet, in order to determine the effect functional foods have~     on blood parameters (cholesterol metabolism, glucose metabolism, hepatic function,~     inflammation, nutritional status) and body composition in the context of four different diets~     (standard, high fat, high protein, low carbohydrate). The study focuses on the effect of~     these nutraceutical foods in relation to different diets. Diets were chosen to reflect the~     standard reference diets used by the general population, so as the outcomes of the addition~     of each interventional food element may be interpreted in the context of a variety of dietary~     patterns.~   "
128145|NCT01890057|"~     To find out the dose of sugammadex for recovery of the TOF ratio to 0.9 within 2 minutes from~     profound rocuronium-induced neuromuscular block in young and elderly adult patients.~   "
128146|NCT01890044|"~     Venous thromboembolism (VTE) remains a leading cause of death in trauma patients. Based on~     the EAST Management Guidelines for the prevention of VTE in trauma patients, a number of~     research questions could be addressed by a thorough current literature review combined with a~     multicenter concurrent analysis. This proposal seeks to create a data registry of trauma~     patients from multiple trauma centers around the United States that will serve as a platform~     for the study of VTE.~   "
128147|NCT01890031|"~     The purpose of this study is to show that we can effectively deliver health information and~     education, online, via computer regarding cholesterol. This computer program is called the~     Interactive Cholesterol Advisory Tool (ICAT).~   "
128148|NCT01890018|"~     The overall objectives of this study are to improve medication adherence of patients and~     subsequent health outcomes.~      This study is designed to examine the existence of strong associations between social~     networks and health behavior. This study intends to demonstrate that social forces are~     particularly effective at building enduring habits for healthy behavior, specifically~     adherence to statin medication for this study. The investigators believe the improved~     medication adherence will result in fewer additional vascular events, following the most~     recent of these events, and will result in fewer patient hospitalizations. The investigators~     will leverage insights from the fields of social comparison (being provided with information~     about the actions of others prompts social comparison that can significantly influence~     behavior), social pressures (encouragement or discouragement from others is a powerful social~     force that can influence individual behavior), and social triggers (cues in the environment~     can motivate people to take certain actions and have powerful effects on purchasing~     behavior).~      The results of this study and experience gained from the implementation of these~     interventions will be used to inform new versions of a larger trial intervention to be tested~     in new patient cohorts in a rapid cycle framework.~   "
128149|NCT01890005|"~     Preeclampsia is one of the three leading causes of maternal morbidity and mortality all over~     the world. The use of low dose aspirin has been mentioned in several studies with promising~     results. The investigators decided to evaluate the use of low dose aspirin, starting between~     13 and 16 weeks of pregnancy, based on clinical characteristics only to reduce the incidence~     of preeclampsia.~   "
128150|NCT01889992|"~     Cardiac allograft remodeling causes poor quality of life, allograft failure and increased~     mortality after heart transplantation. Risk factors for cardiac allograft remodeling and its~     progression are poorly defined and there is a need for effective interventions.This is a~     multi-factorial phenomenon, associated with various immunological and non-immunological~     factors. Animal studies suggest M-TOR inhibition attenuates cardiac allograft remodeling~     secondary to down-regulation of M-TOR downstream targets and increased autophagy. There is a~     paucity of data regarding effect of Sirolimus, a M-TOR inhibitor, on human heart remodeling.~      This aim of the proposal to identify the prevalence of cardiac allograft remodeling on~     current immunosuppressive strategies and determine risk factors for its development. It will~     also identify molecular pathways associated with cardiac allograft remodeling and determine~     the impact of Sirolimus on these pathways.~   "
128151|NCT01889979|"~     Tramadol is a centrally acting synthetic analgesic used to treat moderate to moderately~     severe pain. It has been previously evaluated as a method to reduce pain during labour, but~     there is always some fear related to its effects (neonatal respiratory depression). The~     purpose of our study was to evaluate the efficacy of subcutaneous tramadol in regards to pain~     during labour, duration of labour and neonatal outcomes.~   "
128152|NCT01889966|"~     Sildenafil is a selective pulmonary vasodilator; in patients with a special kind of pulmonary~     hypertension it is approved for treatment. The trial seeks to find out, whether the acute~     response to this treatment (= vasoreactivity testing) given intravenously is effective and~     allows prediction of therapy success during a following oral treatment.~   "
128153|NCT01889953|"~     This research is being done to study the safety and feasibility of recruiting patients~     eligible for EUS-guided biliary drainage (EGBD). Our goal is to prospectively study safety~     and effectiveness of this procedure.~   "
128154|NCT01889940|"~     The purposes of the ESPELMA project are twofold: 1) To increase acute spinal cord injury~     patients' satisfaction with treatment while hospitalization and 2) To increase mastery among~     rehabilitation professionals with regard to the clinical management of patients'~     psychological distress.~      For these purposes, a tailored training for professionals will be designed and offered.~      It is hypothesized that building capacity among professionals will serve to better management~     of patients' distress and a greater ability to commit them to the rehabilitation process.~     Thus, it is expected to lead to better and faster functional recovery and consequently to~     higher perceived satisfaction with treatment.~   "
128155|NCT01889927|"~     The primary aim of the research is to evaluate whether an alternative model of cystic~     fibrosis (CF) physiotherapy care can produce statistically significant improvements in~     clinical and patient reported outcomes, and whether this alternative model is economically~     advantageous and/or sustainable.~      Children randomised to the control group will receive 24-months of current model of CF care~     at Great Ormond Street Hospital (GOSH).~      Children randomised to the intervention group will receive 24-months of current model of CF~     care at GOSH PLUS a weekly structured, individually prescribed and personally supervised~     exercise intervention at a local fitness facility or at school. The exercise prescription~     will include aerobic, anaerobic, strength, core conditioning and stretching components.~      The main objectives of the study are:~        1. Determine differences, if any, in lung function between the two groups;~        2. Determine differences, if any, in exercise capacity between the two groups;~        3. Evaluate cost of care of alternate model of care versus current model of care.~   "
128156|NCT01889914|"~     The aim of the TRICIDIA2 study is to compare two modalities of administration of insulin.~      In our future study, the investigators wish to study if the treatment by continuous infusion~     of insulin improves the insulinosensitivity of type 2 diabetic patients; the investigators~     indeed expect that the insulin delivered in a continuous way decreases the~     insulino-resistance of these patients compared with the intermittent delivering of insulin.~   "
128157|NCT01889901|"~     Epilepsy is common in childhood. Throughout life, including adulthood, children with epilepsy~     are at increased risk of impaired health, functioning, psychological well-being and~     quality-of-life. There is evidence that physical activity improves the medical and~     psychosocial aspects of health in adults with epilepsy- but there are no such studies in~     children. The investigators predict that we can increase levels of physical activity and~     influence children's functioning, psychological well-being and quality of life through~     multiple pathways. The investigators propose to evaluate the relationship between enhanced~     physical activity and health, and explore facilitators and barriers to physical activity in~     children with epilepsy.~   "
128158|NCT01889888|"~     Autologous adipose-derived regenerative cells (ADRC) extracted using Celution 800/CRS System~     (Cytori Therapeutics Inc)from a portion of the fat harvested from the patient's front~     abdominal wall. ADRC will be administered one-time endoscopically into submucosal layer of~     urethra under eye control into the stricture site after mechanical dilation. This is a single~     arm study with no control. All patients receive cell therapy.~   "
128159|NCT01889875|"~     Treatment of pollen allergies can be roughly divided into symptomatic treatment (e.g.~     antihistamines, steroids) and potentially curative immunotherapy. Immunotherapy can be~     delivered using subcutaneous or oral (mucosal) routes, with similar clinical outcome. The~     study seeks to compare immunological changes during subcutaneous (SCIT) and sublingual tablet~     (AIT) immunotherapy of grass pollen allergy (hayfever).~   "
128160|NCT01889862|"~     The BMN 165 clinical development program has been designed to demonstrate the safety and~     efficacy of BMN 165 in reducing blood Phe concentrations in adults with PKU.~   "
128161|NCT01889849|"~     This research protocol Comparative pharmacokinetics and pharmacodynamics of peginterferon~     Bacterial Intravenous Protein 48 kilodaltons (BIP48) and 40 kilodaltons (40kDa) in healthy~     volunteers. This is a Phase I clinical trial which will compare pharmacokinetic and~     pharmacodynamic parameters, and safety of two products: peginterferon alfa-2a (PEGASYS ®) and~     BIP48. It will be a double-blind, randomized crossover with a rest period (wash-out) of 4~     weeks. The study population will be 32 healthy male volunteers to whom will be administered a~     single dose of 180 microgram of each product, subcutaneously. The study will have a total~     duration of 14 days in each treatment step. The serum concentration of PEG-interferon for~     both products, measured by enzyme immunoassay (EIA) and by antiviral activity of~     PEG-interferon, is the main variable.For this purpose 15 samples of each volunteers will be~     needed. Clinical and laboratory variables, useful as pharmacodynamics parameters Beta-2~     microglobulin (β2M) - 2'5'oligoadenylate synthetase - oligoadenylate synthetase (OAS)- and~     neopterin) and safety evaluation, will be measured.~   "
128162|NCT01889836|"~     Clinical trial phase I, randomized, double blind, where 30 individuals will receive the~     experimental vaccine while 30 other volunteers will receive a meningococcal C conjugate~     vaccine already licensed in Brazil and available in the National Immunization Program for~     children less than 12 months of age. The primary outcome of the study is to evaluate the~     safety profile of the vaccine under test, which should allow its application in humans.~     Secondly, the investigators will study its immunogenicity from the evaluation of the~     correlates of seroprotection for meningococcal, defined by the World Health Organization~     (WHO).~   "
128163|NCT01889823|"~     It has been shown in in vitro and animal models that hypoxia can have pro-inflammatory~     effects and hyperoxia can have anti-inflammatory effects. The pro-inflammatory effect could~     be the result of activation of Hypoxia Inducible Factor, a transcription factor that is known~     to activate many cell systems aimed at cell survival, including the inflammatory response.~     The anti-inflammatory effects of hyperoxia could be the annihilation of Hypoxia Inducible~     Factor, but also a decrease in inflammation due to oxygen toxicity resulting in a decrease in~     clearance of pathogens. These effects have been sparsely studied in humans. Therefore, we~     hypothesize that hypoxia results in an increase in Hypoxia Inducible Factor in circulating~     leukocytes and increases inflammatory reactions, whereas hyperoxia decreases these reactions.~   "
128298|NCT01888068|"~     A new investigational device (BIA/Vitality Analyzer™) is being compared to a United States~     Food and Drug Approved 'predicate' reference device (EFG®) to demonstrate that they provide~     equivalent measurements of body fat. Both devices are over-the-counter bioimpedance body~     composition analyzers (estimate of body fat). These devices are classified as 'Not~     Significant Risk' devices; they do not expose you to any significant risks.~   "
128164|NCT01889810|"~     Insulin resistance is a state where the body does not respond as it should to the insulin it~     produces. Individuals who are insulin resistant are at increased risk of both heart disease~     and type 2 diabetes; importantly, diabetes more than doubles the risk of heart disease,~     independent of other recognised risk factors. Interventions that prevent or reverse insulin~     resistance may help to attenuate risk of heart disease and diabetes. A number of randomised~     controlled trials provide proof of concept evidence regarding a beneficial effect of vitamin~     D on insulin resistance and other cardiovascular risk markers but experts have stated that~     further studies are required. Importantly, these studies should use appropriate endpoints,~     provide a high enough dose of vitamin D to optimise vitamin D status, and they should be~     conducted in clearly defined populations, The vitamin D trial we propose addresses these~     issues and aims to evaluate a potentially straightforward and low cost health care~     intervention for populations at highrisk of heart disease and diabetes. Specifically, this~     study would provide clinically relevant information on the metabolic effects of optimising~     vitamin D status in these high risk patients. This has clear economic and social implications~     given the current, and projected, burden of heart disease and diabetes.~      This study will investigate the effect of vitamin D3 supplementation on insulin resistance~     and cardiovascular risk factors in people at high risk of type 2 diabetes and cardiovascular~     disease using the gold standard euglycaemic hyperinsulinaemic clamp method.~   "
128165|NCT01889797|"~     Patients with previously untreated low tumor burden indolent Non-Hodgkin's Lymphoma (NHL)~     will receive either rituximab or GA101 weekly for 4 weeks followed by re-staging to determine~     response.~      Rituximab, an anti-CD20 chimeric antibody, was approved by the United States Food and Drug~     Administration in 1998 for the treatment of patients with relapsed low-grade B-cell~     lymphomas. Clinically, four weekly doses of rituximab have proven to be well tolerated and~     effective in previously untreated as well as relapsed patients with low-grade lymphoma.~      GA101 is an anti-CD20 humanized and glyco-engineered monoclonal antibody. GA101 has been~     shown to have increased antibody-dependent cellular cytotoxicity (ADCC) and direct cell-death~     induction compared to Rituximab. It is possible that GA101 may have greater efficacy than~     rituximab.~      PrE0401 Sub-Study Evaluation of Corrected QT (QTc) Interval and Pharmacokinetic Parameters in~     Patients Participating in GA101 (Obinutuzumab)~      Approximately twenty-five patients randomized to GA101 may participate in the sub-study.~     Electrocardiograms and blood samples will be obtained.~   "
128166|NCT01889784|"~     The purpose of this study is to determine the phototherapy may be adjuvant to exercise to~     improve muscular efficiency and increase aerobic capacity. We hypothesized that phototherapy~     adjuvant with physical exercise may be benefit to populations with Diabetes mellitus that~     have impairment in cardiopulmonary fitness and low oxygen uptake peak values (VO2peak) in~     exercise tests. Two doses will be tested 150J and 300J.~      Additionally, this study aims to evaluate the effect of phototherapy previously applied to~     the exercise on the cardiovascular coupling. We hypothesize that phototherapy previously~     applied to the exercise will result in the increase baroreflex sensitivity (increased~     coherence and gain and decreased phase), promoting the improvement of the cardiovascular~     autonomic control and cardiovascular coupling in diabetic subjects. Two doses will be tested~     150J and 300J.~   "
128167|NCT01889771|"~     The study is to understand whether distribution of two different supplies of nicotine patches~     through a telephone quitline has an effect on quit rates. The two different supplies are four~     vs. eight (in two separate four-week mailings) weeks of nicotine patches. The hypothesis is~     that eight weeks will be slightly more efficacious but four weeks will be more~     cost-effective.~   "
128168|NCT01889758|"~     The study is designed to compare the steady-state pharmacokinetics of Prograf (Brand) and the~     two most disparate generic formulations (Generic Hi and Generic Lo) in a fully replicated,~     3-way cross-over study in stable kidney (n=36) and liver transplant (n=36) subjects.~   "
128169|NCT01889745|"~     This study is designed to multiple dose and dose escalation study~   "
128170|NCT01889732|"~     Rotational thromboelastometry (ROTEM) is reliable point of care management of coagulation~     disorder undergoing surgery. Recently, there are some reports about prediction of~     perioperative bleeding using ROTEM. But, the effectiveness of ROTEM for predict bleeding and~     improve outcomes is still debate. In this retrospective study, the investigators will compare~     immediate postoperative bleeding with ROTEM parameters using a Gray zone approach, and access~     the reliability of ROTEM for prediction of bleeding after cardiac surgery.~   "
128171|NCT01889719|"~     This trial will investigate whether immunizations with an MVA recombinant HIV vaccine are~     safe and whether they will boost immune responses generated by immunizations with a dendritic~     cell (DC) targeted protein vaccine, DCVax-001, plus poly ICLC in healthy HIV-uninfected~     volunteers.~   "
128172|NCT01889706|"~     The use of exogenous insulin and incorrect nutritional habits are conducive to obesity and~     excess weight. This leads to the development of insulin resistance, even in patients with~     type 1 diabetes mellitus. The purpose of this study is to assess the effects of metformin as~     adjunctive therapy on anthropometric parameters, insulin resistance and metabolic control in~     overweight and obese patients with type 1 diabetes mellitus.~      The study group consists of 200 Caucasian type 1 diabetic patients with elevated adipose~     tissue content as measured by electrical bioimpedance, treated at the Poznan University of~     Medical Sciences Department of Diabetology in 2009-2014. All patients have type 1 diabetes~     diagnosed by autoimmune antibodies, and are treated with intensive insulin therapy. This~     group is divided into metformin treated arm (group I+ M, 100 subjects), the remaining 100~     patients are treated with insulin alone (control group, group I). Metformin is administered~     at least 6 months at a mean dose of 1000 mg/day.~      The investigators would like to assess the impact of metformin treatment on metabolic~     control, insulin resistance and anthropometric parameters in overweight and obese patients~     with type 1 diabetes.~   "
128186|NCT01889524|"~     In vivo deposition studies of aerosol administration during noninvasive ventilation are~     scarce in the current literature.~      We assessed 10 normal subjects in a crossover study evaluated by pulmonary scintigraphy~     aiming to compare radiaoaerosol pulmonary index and radioaerosol mass balance in the~     different compartments (pulmonary and extrapulmonary) of radiotagged aerosol administered~     using vibrating mesh nebulizers (VMN) and conventional jet nebulizer (JN) during noninvasive~     ventilation (NIV).~   "
128173|NCT01889693|"~     Despite of intensive efforts, no specific ath¬erosclerosis-targeting agent labeled with~     positron emitter is not yet available. Fortunately, some scientists made the major advance in~     the field of clinical atherosclerosis molecular imaging by the metabolic PET reporter agent~     18F(fluorine-18)-FDG(Fludeoxyglucose) applied to noninvasively image plaque macrophages in~     carotid arteries. However, coronary and cerebral arterial segments remain uninterpretable due~     to metabolic property of 18F-FDG. Applying the character of the terminal mannose residues of~     MSA binding with the mannose receptors of macrophages in atherosclerosis, we investigate~     whether 68Ga-MSA can be a novel agent for non-invasive molecular imaging of atherosclerotic~     lesion in PET.~   "
128174|NCT01889680|"~     FC-8 is a Phase II, multi-center randomized study of a continuation regimen of 5-FU/LV with~     ziv-aflibercept or 5-FU/LV alone (control arm) following the induction regimen of mFOLFOX6~     and ziv-aflibercept as first-line therapy for patients with metastatic colorectal cancer. The~     primary aim of the study is to determine the value of adding ziv-aflibercept to the~     continuation regimen of 5-FU/LV in improving progression-free survival (PFS) of patients with~     metastatic colorectal cancer who have achieved at least stable disease after induction~     therapy. The secondary aim is to determine the overall objective response rate (complete,~     partial or stable responses) by Response Evaluation Criteria in Solid Tumors (RECIST 1.1).~   "
128175|NCT01889667|"~     The purpose of this study is to test the safety and pharmacodynamics of an oral formulation~     of insulin in subjects with Type 2 Diabetes.~   "
128176|NCT01889654|"~     Lupus disease is characterized by the production of pathogenic autoantibodies, which~     participate in end-organ damages. The phenotype of B cells producing the pathogenic~     autoantibodies in lupus patients is today unknown. Antinucleosome antibodies are~     characteristic of lupus disease.This project proposes to detect antinucleosome B cells in~     lupus patients and to analyse their phenotype and their frequency.~   "
128177|NCT01889641|"~     Treatment of multisystemic forms of lupus displays severe side effects and limited efficacy,~     underscoring the need to better dissection of the pathogenic mechanisms. Concordant with~     preliminary data, IL26 signaling could be impaired in systemic lupus. Moreover, IL 26 could~     be a marker of the disease activity and then a potential therapeutic target. In the present~     study, serum IL 26 level in lupus patients and control will be measured.~   "
128178|NCT01889628|"~     Nutritional formula drinks are widely consumed in Asia especially by those having chronic~     illnesses such as diabetes. Therefore, gauging the impact of nutritional formulas on blood~     glucose levels is very important. Asia is home to three predominant ethnic groups- Chinese,~     Malay and Indians. It is still unknown if the blood glucose response to nutritional formulas~     differs between ethnic groups. Therefore the aim of this study is to observe if there are~     ethnic differences in the blood glucose response to nutritional formula drinks.~   "
128179|NCT01889615|"~     The investigators want to compare the use of MRI with PET/CT preformed after 1 hour and 3~     hours in preoperative assessment of resectability.~      The investigators' hypothesis is that dual time PET/CT performed at 60 and 180 minutes will~     increase the diagnostic accuracy of conventional PET (performed at 60 minutes) in~     preoperative assessment of resectability.~      Further more the investigators suggest that the GLUT/G6Pase index correlates to the SUVmax.~     And retention index (RI, see Methods - PET protocol) is a prognostic marker in ovarian~     cancer.~   "
128180|NCT01889602|"~     Cognitive impairment is a widely reported side effect of many commonly used drugs. Even a~     mild, untoward effect on an essential function such a linguistic behavior, a directly~     observable product of complex cognitive processes, is disruptive to daily life. Nevertheless,~     the mechanisms underlying a drug's impact on cognition are poorly understood. This lack of~     understanding impedes the ability to predict both the effects of drugs in development and the~     degree to which an individual is vulnerable to the cognitive impact of a particular agent.~     Topiramate (TPM, an antiepileptic drug) is, with increasing frequency, being prescribed for a~     range of conditions including migraine prophylaxis, obesity and pain. It is a prime example~     of a drug that causes speech and language problems severe enough in some patients to result~     in discontinuation of therapy. For reasons not well understood, TPM has a poorer cognitive~     profile than many of the older antiepileptic drugs. The investigators' rational for this~     study is that it will offer insight into the mechanisms underlying drug-induced cognitive~     deficits.~   "
128181|NCT01889589|"~     This surveillance project will assess NYC population sodium intake using the gold standard~     measurement of 24-hour urine collection. This surveillance project is a critical component of~     a larger initiative, coordinated by NYC, to reduce sodium intake nationwide through voluntary~     industry reductions in processed food sodium content. The project will assess current~     population sodium intake, against which population intake changes at three years can be~     assessed~   "
128182|NCT01889576|"~     Hypomagnesemia is common early after transplantation, especially in association with~     calcineurin inhibitors and predicts diabetes after transplantation. Magnesium improves~     glycemic control and insulin sensitivity in diabetics and insulin resistant subjects without~     diabetes but this was never evaluated in transplant recipients.~      The aim of the study is to assess whether magnesium improves glycemic control and insulin~     sensitivity early after transplantation.~      The study is an open label study in which adult hypomagnesemic renal transplant recipients~     are randomized the first 2 weeks after kidney transplantation to magnesium oxide or no~     supplementation.~      The hypothesis is that magnesium supplementation in renal transplant recipients exerts a~     beneficial effect on glycemia and the development of diabetes after transplantation.~   "
128183|NCT01889563|"~     To contrast the potential effects of physical exercise training program (PTP) of a 6 versus~     12 weeks on cardiac autonomic modulation by linear and non-linear heart rate variability~     (HRV) indices and functional capacity in moderate-to-severe COPD patients.~   "
128184|NCT01889550|"~     The research aims at generating new knowledge about ways to inform pregnant women about~     prenatal screening for Downs syndrome.~      The overall purpose of this project is to increase pregnant women's knowledge of prenatal~     screening for Downs syndrome, and thereby an option to make an informed choice. The project~     is planned as a research into whether the use of an eHealth solution (in this project an~     interactive website) may be an appropriate intervention for pregnant women.~   "
128185|NCT01889537|"~     The purpose of the research is to see whether a low dose of ketamine, a medication used to~     reduce pain, enhances the effectiveness of a virtual reality video game, which is used as a~     form of distraction from pain during a painful burn care procedure.~   "
128187|NCT01889511|"~     The purpose of this Academic Research Enhancement Award proposal is to conduct a small-scale~     health-related research project on text messages to improve adherence to oral chemotherapy~     agents. Michigan State University College of Nursing has not been a major recipient of~     National Institute of Health grant funding. As a result, the overall objective of this~     proposal is to strengthen the research environment in the College of Nursing so that it can~     develop into a significant health-related scientific research enterprise. This project would~     involve undergraduate and graduate students, and thus, generate student interest in research~     as a career. The importance of the research planned for this proposal is as follows. More~     than 50 oral chemotherapy agents in pill form are currently on the market, with projections~     that in 3 years, 25% of cancer treatments will be delivered in pill form. For oral agents to~     achieve a therapeutically effective level for cancer treatment, patients must strictly adhere~     to the regimen. Adherence to oral cancer agents is often less than 80%, which may be~     inadequate for treating the cancer. To date, empirical research in the area of improving~     adherence to oral agents is underdeveloped. The goal of this research is to improve adherence~     to oral chemotherapy agents through a technology based strategy, tailored SMS text messages.~     This prospective randomized controlled trial will examine the feasibility, acceptability, and~     satisfaction with a 3-week tailored text message intervention for oral agent adherence.~     Descriptive statistics, generalized linear modeling, and generalized estimating equations~     will be used for analysis. In this proposal, preliminary data will be collected to examine~     efficacy of the text message intervention to promote adherence to oral agents. Data will then~     be used to further inform the development of an intervention to improve adherence to oral~     agents for an R01 application to conduct a larger randomized trial to test this innovative~     intervention. This study can have a transformative impact on oral agent adherence by~     developing a technology-based strategy to promote adherence among the increasing number of~     cancer patients who receive their cancer treatment in pill form. This type of novel~     intervention also has the potential to transform and impact many other ill populations that~     require adherence to a medication regimen.~   "
128188|NCT01889498|"~     The aorta is a large vessel that carries blood away from the heart. Sometimes it becomes~     dilated (swells) and this is known as 'aneurysm'. It may cause either dissection (splitting~     of the wall) or rupture (bursting).~      Treatments could be through open surgery or by use of stents (tubular mesh) through the~     groin. There is a risk of causing paraplegia, which is the loss/weakness of leg function as~     well as incontinence (loss of bladder and/or bowel control).~      To try and prevent this, a number of techniques are used such as removing/draining of~     cerebrospinal fluid (CSF) (the clear fluid surrounding the brain and spinal cord).~      Sometimes however;~        -  CSF cannot be drained~        -  drain cannot be inserted~        -  draining is unlikely to improve the situation~        -  Paralysis/weakness of the leg is seen~      In these situations, the use of a drug called acetazolamide may be helpful. This reduces the~     production of CSF and therefore decreases the need for CSF draining. It may also have an~     effect in decreasing the risk of paraplegia.~      Patients will be randomly (by chance) placed into one of two groups. One will get the drug as~     tablets and injection and the other will not receive any acetazolamide at all. Blood tests~     will be done in both groups. We expect to have 100 patients in the study, with patient~     involvement for a total of 10 days (maximum).~   "
128189|NCT01889485|"~     This is a pilot study designed to validate our methods of recruitment, screening and data~     collection in the community. The project will help to establish the feasibility of the study~     design to lay the groundwork for a potentially larger study. The final study will allow us to~     estimate the incidence and prevalence of abdominal aortic aneurysm (AAA), carotid artery~     stenosis, and peripheral artery disease (PAD) in different geographic areas in a large urban~     setting, as well as determine patient access to healthcare and treatment for vascular disease~     as related to geographic and racial differences.~   "
128190|NCT01889472|"~     CPAP is the most effective treatment of obstructive sleep apnea. Oro-nasal masks may be used~     in case of mouth leaks but these are associated with higher positive pressure needs and lower~     compliance to treatment. The present investigation evaluates if CPAP compliance would~     increase when an oral appliance is used in combination with a nasal mask compared to the use~     of an oro-nasal mask. Eligible patients are those demonstrating a low compliance when using~     an oro-nasal mask during CPAP therapy. Patients will be treated with automatic CPAP with one~     of the above-detailed interfaces for 4 weeks and data will be extracted from the machine~     report in each condition.~   "
128191|NCT01889459|"~     The purpose of this study is to establish a consensus of treatment strategy of percutaneous~     coronary intervention (PCI) for chronic total occlusion (CTO) through patient registry of PCI~     for CTO performed by Japanese certified operators.~   "
128192|NCT01889446|"~     Propionic acid (PA) is used as a preservative in foods such as cheeses, baked goods, or~     additive for artificial fruit flavors. The U.S. Environmental Protection Agency considers it~     safe and therefore, has no limitation on its use. Since PA has been shown before to serve as~     a substrate for glucose production in the liver, the purpose of this study is to find out if~     PA intake causes changes in levels of glucose, insulin and other important hormones following~     a meal.~      This research study will compare PA to placebo. The placebo looks exactly like the active~     substance, but it does not contain any active agent (PA). Placebos are used in research~     studies to see if the results are due to the study drug or to other reasons.~      The investigators plan to have 20 subjects take part in this study at the Brigham and Women's~     Hospital (BWH).~   "
128193|NCT01889433|"~     The purpose of the study is to demonstrate the noninferiority of Algeron in combination with~     ribavirin compared to Pegasys in combination with ribavirin in the treatment of chronic~     hepatitis C.~   "
128194|NCT01889420|"~     This study is being conducted to test the possibility that a combination of three drugs,~     pomalidomide and everolimus with dexamethasone, may improve patient responses when compared~     with use of either drug alone, with dexamethasone in refractory/relapsed multiple myeloma.~   "
128195|NCT01889407|"~     Whether Idarubicin can overcomes multidrug resistant 1 induced chemoresistance with higher~     induction remission rate than daunorubicin in de novo acute myeloid leukemia patients.Whether~     induction therapy with IA regimen has a higher remission quality with AML patients than that~     of DA regimen in high MDR1 expression AML patients.~   "
128196|NCT01889394|"~     To compare primary wound closure using a limberg flap with secondary (p.s.) wound healing~     following excision of a pilonidal sinus.~   "
128217|NCT01889121|"~     Opiate drug abuse/addiction is a significant co-morbidity in pregnancy. Opiate maintenance~     program enhances the outcome of pregnancies for the mother and the infant. Our objective was~     to assess if provision of structured psychosocial support in addition to methadone~     maintenance program adds incremental benefits with regards to the outcome of pregnancy.~   "
128299|NCT01888055|"~     The aim of this study is to investigate whether the anodal transcranial direct current~     stimulation (tDCS) over the primary motor cortex (M1) in healthy older adults leads to an~     increase in cortical plasticity (change in motor evoked potentials (MEP) in mV).~   "
139504|NCT01741337|"~     The aim of this clinical trial is to evaluate the effect of an early treatment of~     sleep-disordered breathing by adaptive servo-ventilation in heart failure patient following~     coronary artery bypass graft surgery or other coronary reperfusion.~   "
128197|NCT01889381|"~     Background: The human face is critically important for breathing, eating, seeing, and~     speaking/ communicating, but its most important job may be to look like a human face.~     Devastating facial deformities often cause affected individuals to avoid human contact and~     disappear from society. Although current surgical advancements can somewhat restore facial~     defects, this process often requires many operations and the resulting face only resembles~     the human face. To date, over 20 face transplants have been performed with highly encouraging~     functional and aesthetic results, but widespread clinical use has been limited due to the~     adverse effects of life-long and high-dose immunosuppression needed to prevent graft~     rejection. Risks include infection, cancer, and metabolic problems, all of which can greatly~     affect recipients' quality of life, make the procedure riskier, and jeopardize the potential~     benefits of face transplantation.~      Study Design: This non-randomized, Phase II clinical trial will document the use of a new~     immunomodulatory protocol (aka - Pittsburgh Protocol, Starzl Protocol) for establishing face~     transplantation as a safe and effective reconstructive treatment for devastating injuries/~     defects by minimizing maintenance immunosuppression therapy in face transplant patients. This~     protocol combines lymphocyte depletion with donor bone marrow cell infusion and has enabled~     graft survival using low doses of a single immunosuppressive drug followed by weaning of~     treatment. Initially designed for living-related solid organ donation, this regimen has been~     adapted for use with grafts donated by deceased donors. The investigators propose to perform~     15 full or partial human face transplants employing this novel protocol.~      Specific Aims: 1) To establish face transplantation as a safe and effective reconstructive~     strategy for the treatment of devastating facial injuries/defects; 2) To reduce the risk of~     rejection and enable allograft survival while minimizing the requirement for long-term,~     high-dose, multi-drug immunosuppression.~      Significance of Research: Face transplantation could help injured individuals recover~     functionality, self-esteem, and the ability to reintegrate into family and social life as~     whole individuals. This protocol offers the potential for minimizing the morbidity of~     maintenance immunosuppression, thereby beneficially shifting the risk/benefit ratio of this~     life-enhancing procedure and enabling a wider clinical application of face transplantation.~   "
128198|NCT01889368|"~     In people with the metabolic syndrome, the investigators hypothesize that administration of a~     single 300 mg dose of a grape seed extract (GSE) will reduce insulin resistance (how well~     cells in the body can take up and use glucose), oxidative stress, and the amount of oxidized~     LDL in the blood during a 24 hour period. These measurements will be assessed at hourly~     intervals during the 24 hour study day protocol. Additionally, the investigators hypothesize~     that daily administration of 300 mg of GSE for 30 days will decrease baseline insulin~     resistance, oxidative stress, and the level of oxidized LDL in the blood.~   "
128199|NCT01889355|"~     This enhanced meter feature raises awareness among patients by providing additional~     information regarding their glycemic control in between Healthcare Professional visits. This~     information may facilitate increased dialogue between patient and Healthcare Professional and~     can remind patients of the importance of glycemic control.~      This study will evaluate a user's ability to use the enhanced meter feature.~   "
128200|NCT01889342|"~     Comorbidity is normal in clinical practice. Metacognitive Therapy (MCT) is a transdiagnostic~     model and could therefore be well suited when it comes to treating patients with high rates~     of comorbidity. So far, no studies have examined MCT in comparison with the best documented~     and evidence based treatment, cognitive behavioral treatment(CBT), in a randomized controlled~     trial consisting of mixed anxiety disorder sample with high degree of comorbidity.~      The main aim of this study is to 1) Evaluate the effectiveness of metacognitive therapy in a~     sample of mixed anxiety disorders as compared to a group receiving existing evidence-based~     single diagnosis CBT- treatment protocols 2) Investigate patterns and mechanisms of change in~     the two treatments.~   "
128201|NCT01889329|"~     Around 0.5 million under-five children are currently suffering from severe acute malnutrition~     (SAM) in Bangladesh and are at risk of death. Children with SAM and complications should be~     treated in a health care facility. It is imperative, however, to manage children with SAM but~     without any complications in the community. This requires a ready-to-use-therapeutic food~     (RUTF) that conforms to standard recommendations on its composition. The prototype RUTF is~     peanut based, made outside Bangladesh, and has to be imported. By developing a RUTF using~     local food ingredients, test it for acceptability and efficacy in the treatment of children~     with SAM, hopefully make the treatment of SAM cost-effective and sustainable.~      Hypothesis: Does the locally developed ready-to-use-therapeutic foods (RUTFs) demonstrate~     similar or better acceptability and efficacy in the treatment of children suffering from~     severe acute malnutrition (SAM) when compared to the prototype RUTF (Plumpynut)?~   "
128202|NCT01889316|"~     This is a prospective clinical trial involving the use of the FDA-cleared Fetal ECG tracing~     in labor with the AN24 (Fetal Monitoring device marketed by Monica Healthcare) to the Novii~     (a newer device also created by Monica Healthcare) using the same technology with different~     monitor placement.~   "
128203|NCT01889303|"~     Concurrent chemoradiotherapy has been demonstrated a significant improvement in overall~     survival and disease-free survival according to Intergroup Trial 0116 in patients with~     gastric cancer after surgical resection. However,there are still many patients experiencing~     local recurrence or distant metastasis after adjuvant chemotherapy and concurrent~     chemoradiotherapy for locally advanced gastric cancer after resection. The optimal and~     standard regimen for adjuvant treatment has not been established in locally advanced gastric~     cancer yet.The investigators designed the trial to investigate the efficacy and safety of~     docetaxel plus cisplatin regimen as adjuvant chemotherapy and concurrent chemoradiotherapy~     regimen compared with classical FOLFOX6 regimen as adjuvant chemotherapy and 5-FU/CF as~     chemoradiotherapy in patients of locally advanced gastric cancer after D2 radical resection.~   "
128204|NCT01889290|"~     -  Assessment of pharmacokinetic parameters of once daily subcutaneously administered~          methylnaltrexone in 10 evaluable neurointensive care patients.~        -  Quantification of methylnaltrexone passage through the blood-brain-barrier in critically~          ill patients with severe cerebral affections.~        -  Observation of laxation response after methylnaltrexone application and relation to~          plasma concentrations of methylnaltrexone.~        -  Assessing the safety of once daily administered methylnaltrexone in neurointensive care~          patients.~        -  Trial with medicinal product~   "
128205|NCT01889277|"~     The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of MT-3995~     in Subjects with Diabetic Nephropathy~   "
128229|NCT01888965|"~     This study is for patients with stage 4 colon cancer who have had initial chemotherapy or had~     surgery to remove metastases and patients with pancreas cancer, which has been surgically~     removed and are receiving adjuvant chemotherapy or is locally advanced and have already~     received chemotherapy and radiation.~      The purpose of this study is to determine the effects of oral dovitinib in patients with~     advanced stage colorectal and pancreas. Effects include biomarker changes, progression-free~     survival and safety. Dovitinib will be taken by mouth for 5 days out of every week for up to~     2 years.~   "
128206|NCT01889264|"~     Critically ill children have abnormal utilization of nutrients such as glucose, lipids and~     protein. Protein synthesis is increased mainly in the form of immune and signaling proteins,~     while muscle and structural protein synthesis is decreased. The metabolism of sulfur amino~     acids through the splanchnic area and specifically methionine and cysteine have not been~     investigated in critically ill septic children, despite that sulfur amino acids have~     important roles in thiol, antioxidant and epigenetic reactions. Methionine metabolism in sick~     children will be influenced by its rate of utilization through different pathways. Our study~     aims to investigate the metabolism of methionine and cysteine when both amino acids are given~     by the enteral route in critically ill septic children. The investigators are focused on the~     rates of transmethylation, remethylation and transsulfuration in critically ill septic~     children, and if the current standard nutrition maintains methionine nutritional balance and~     functional requirements in critically ill children fed by the enteral route.~   "
128207|NCT01889251|"~     The purpose of this study is to evaluate the superiority regarding vitreomacular adhesion~     (VMA) resolution of a single intravitreal injection of A01016 (Ocriplasmin) compared to~     sham-injection in subjects with symptomatic VMA.~   "
128208|NCT01889238|"~     The purpose of this study is to determine if enzalutamide is safe and effective in the~     treatment of patients with advanced breast cancer that express the androgen receptor but do~     not express the estrogen or progesterone receptor and are not Her2 amplified.~   "
128209|NCT01889225|"~     Previous analyses of the National Health and Nutrition Examination Survey have suggested that~     the mortality rate associated with obesity has decreased over calendar time in the U.S.~     population, potentially due to improvements in the medical care of obesity and its associated~     diseases. The primary aim of this project is to evaluate whether this reduction in the~     detrimental association of obesity with mortality rate over calendar time is supported by~     other data from U.S. prospective studies.~   "
128210|NCT01889212|"~     New treatment strategies have been developed in lung cancer targeting the Epidermal Growth~     Factor Receptor (EGFR). Patients with an activating mutation in the EGFR have high responds~     rates to the treatment and should be treated with a EGFR inhibitor as first line of~     treatment. Some wild type patients do as well respond but selection of these patients is more~     difficult.~      Erlotinib has been labeling with 11C and used as a new PET tracer. Accumulation of the tracer~     (11C-erlotinib) in tumors has showed promising results for selection of responders.~      The investigators now want to conduct a larger clinical study to evaluate if accumulation of~     tracer on a pre-treatment 11C-erlotinib PET/CT can predict responds to erlotinib.~   "
128211|NCT01889199|"~     The purpose of this research study is to collect specimen samples and study medical~     information from women with Polycystic Ovary Syndrome (PCOS) and women without PCOS. The goal~     is to learn more about the changes that take place in the body that result in PCOS.~      We anticipate that 59 women will take part in this study (15 without PCOS and 44 with PCOS).~     All patients will undergo a physical exam, blood tests, and ultrasound of their ovaries. If~     they meet the criteria for this study, they will then undergo additional blood tests, removal~     of a small amount of subcutaneous abdominal fat, measurement of regional body fat (i.e., MRI,~     DXA scan), a modified frequently-sampled intravenous glucose tolerance test (FSIGTT), and~     determination of ovarian function (via a follicle stimulating hormone [FSH] test). The women~     without PCOS will be complete the study at this point.~      The women with PCOS will be randomized to receive the drug flutamide 125 mg/day or placebo.~     They will take the drug every day for six 28-day cycles. They will be asked to collect and~     store a urine sample once a week. They will also be asked to complete a pill diary and~     menstrual diary. Once a month while they are taking the flutamide/placebo, they will return~     to the clinic and bring their frozen urine samples. At that time they will undergo a physical~     exam, toxicity assessment, and blood draw.~      Quality of Life assessments will be done at the beginning of the study for all participants.~     Women with PCOS who are taking the flutamide or placebo will be asked to repeat the Quality~     of Life assessments during the study and at the end of the study.~      Six months following the completion of protocol procedures, participants who received~     flutamide/placebo will be contacted by phone to check on the status of their health. They~     will be asked if they have experienced any health problems or have become pregnant since they~     completed the study procedures.~      After the six 28-day cycles are completed they will then undergo additional blood tests,~     removal of a small amount of subcutaneous abdominal fat, measurement of regional body fat~     (i.e., MRI, DXA scan), a modified frequently-sampled intravenous glucose tolerance test~     (FSIGTT), and determination of ovarian function (via a FSH test).~   "
128212|NCT01889186|"~     This is a Phase 2, open label, multicenter, study evaluating the efficacy and safety of~     ABT-199 in relapsed or refractory subjects with CLL harboring 17p13 (TP53 locus) deletion.~     One hundred seven (107) subjects were enrolled in the main cohort, with evaluation of~     efficacy as the primary objective, and approximately 50 subjects will be enrolled in the~     safety expansion cohort to evaluate safety and updated tumor lysis syndrome prophylaxis and~     management measures. Enrollment into the main cohort is closed. Enrollment into the safety~     expansion cohort is closed.~   "
128213|NCT01889173|"~     Very low dose (VLD) cyclobenzaprine at bedtime has shown promise as a treatment for~     fibromyalgia, but the chemistry of cyclobenzaprine requires new formulation technology for~     bedtime use. The present trial is designed to assess the safety and tolerability of 3~     different formulations of TNX-102 2.8 mg SL Tablets (a new formulation of cyclobenzaprine~     designed to result in increased dosage precision and decreased potential for morning~     grogginess) and to compare the bio-availability of 3 different formulations of TNX-102 2.8 mg~     SL Tablets (TNX-102 with potassium phosphate, TNX-102-B with sodium phosphate, and TNX-102-C~     with trisodium citrate) to that of cyclobenzaprine (5 mg tablets).~   "
128214|NCT01889160|"~     Study to investigate the safety profile of AZD4721 after single doses at different dose~     levels~   "
128215|NCT01889147|"~     In the present study human recombinant placental alkaline phosphatase (hRESCAP) will be~     investigated. Alkaline Phosphatase is naturally present in the body and reported to use~     lipopolysaccharde (LPS, bacterial endotoxins) and extracellular nucleotides leaking from~     damaged and ischemic cells as physiological substrates. The LPS-substrate prevalence makes~     alkaline phosphatase an interesting novel therapeutic agent in the treatment of LPS-mediated~     diseases. A bovine homologue of this protein (bovine intestinal alkaline phosphatase, BIAP)~     has previously been investigated for treatment of acute inflammatory responses such as~     sepsis, and was shown to be safe in humans. hRESCAP, which will be investigated in the~     current study, is expected to have a longer half-life in humans than the previously~     investigated BIAP, due to the fact that it is more sialylated. The possibility to increase~     the t1/2 to days instead of minutes enables treatment of chronic diseases.~   "
128216|NCT01889134|"~     The purpose of this study is to determine whether osteoprotegerin and RANKL (receptor~     activator of nuclear factor-κB ligand) are involved in bone remodeling in patients with~     primary hyperparathyroidism (PHPT), and whether alendronate may be useful in treatment of the~     patients with PHPT who are not treated with parathyroidectomy.~   "
128264|NCT01888510|"~     This clinical trial studies computed tomography (CT) in diagnosing patients with lung cancer.~     Diagnostic procedures, such as CT, may help find and diagnose lung cancer.~   "
128218|NCT01889108|"~     The proposed feasibility study will evaluate the investigators ability to conduct a clinical~     trial of a novel intervention (SPEEDI) which addresses a striking gap in the literature.~     Supporting Play, Exploration, and Early Development Intervention (SPEEDI) differs from~     current early intervention practices in 2 important ways. First it bridges the traditional~     gap in services from the Neonatal Intensive Care Unit (NICU) to home providing ongoing and~     intensive support for developmental activities when parents are establishing care giving~     routines. Second, in contrast to wide-ranging intervention provided by current early~     intervention models, SPEEDI uses an action perception model to target specific behaviors~     which lead to improved early motor abilities and provide a foundation for learning.[6] The~     purpose of this feasibility study is to extend the investigators preliminary data and~     evaluate the feasibility of conducting a randomized control trial to evaluate the efficacy of~     SPEEDI.~   "
128219|NCT01889095|"~     Glycemic control is fundamental in the management of diabetes mellitus .If lifestyle~     intervention and full tolerated doses of one or two oral glucose lowering drugs (OGLDs) fail~     to achieve or sustain glycemic goals, insulin should be initiated. New insulin analogs are~     generated to improve glycemic control .New insulin analogs are generated to improve glycemic~     control,However, the cost of these analogs is a major problem .The aim of this piggy back~     evaluation was to assess the effect of BIAsp 30 versus NPH plus regular human insulin on~     metabolic control as well as its cost-effectiveness in people with type 2 diabetes in the~     Iranian setting.~   "
128220|NCT01889082|"~     A randomized pilot study will be conducted, the goal of which is to determine which format~     represents the most viable approach to behavioral weight loss treatment with 18-25 year olds.~     Specifically, participants will be randomized to one of three arms; all arms will receive a~     12-week behavioral weight loss intervention, including identical dietary, physical activity,~     and weight loss prescriptions.~   "
128221|NCT01889069|"~     This single arm, multicenter study will evaluate the safety, efficacy and pharmacokinetic~     (PK) of subcutaneous (SC) rituximab in previously untreated participants with cluster of~     differentiation 20 positive (CD20+) DLBCL or FL. In addition to standard chemotherapy,~     participants will receive at least 4 doses of rituximab 1400 mg SC once a month during the~     Induction period, and at least 6 doses of rituximab 1400 mg SC once every two months during~     the Maintenance period.~   "
128222|NCT01889056|"~     The blood hormone Erythropoietin (Epo) is not only produced by the kidneys but also by the~     brain, especially under hypoxic conditions. It has been shown in animal studies and human~     studies that Epo has neuroprotective properties. Furthermore, there is scientific evidence~     for central modulatory effects of Epo in the brain but high dose of Epo is needed to overcome~     the blood brain barrier. In a double blind placebo controlled crossover study we will~     investigate the effects of a single high dose of Epo on cognitive function and exercise~     capacity in healthy subjects. The subjects will receive a single high dose of Epo (60.000 IU)~     and will perform a computerized cognitive test battery, a breathing test, a maximal exercise~     capacity test (VO2max), and a time trial (TT) 24 hours after the treatment. The primary~     outcome of the study will be the cognitive function.~        -  Trial with medicinal product~   "
128223|NCT01889043|"~     Non-invasive ventilation (NIV) has already shown to improve survival and quality of life in~     patients with amyotrophic lateral sclerosis (ALS). Quality of sleep seems already to be~     impaired in patients with preserved diaphragmatic dysfunction. Until now, only few research~     has been performed on the quality of sleep in patients with ALS when using NIV, and these~     data are mainly based on patient reported outcomes.Further on, only very little research has~     been done on patient-ventilator interaction.~      Our study would like to perform research on quality of sleep before and after NIV use by~     using full polysomnography with incorporation of transcutaneous carbon dioxide measurement~     and built-in ventilator software.~   "
128224|NCT01889030|"~     This is an observational, cross-sectional, national multicenter study, trying to obtain local~     data about the global cardiovascular risk profile of patients attending ambulatory offices of~     general practitioners and cardiologists.~      The aim of the study is to describe how physicians diagnose and stratify their patients in~     cardiovascular primary prevention setting and to highlight if patients are stratify through~     objective tools (risk scores and in this case, wich of them are used) or in subjective ways~     (clinical evaluation).~   "
128225|NCT01889017|"~     Extent of use of generics immunosuppressive drugs in clinical practice after lung~     transplantation~   "
128226|NCT01889004|"~     The explanation of consciousness poses one of the greatest challenges to science and~     philosophy in the 21st century. It remains unclear what consciousness is and how it emerges~     from brain activity. By studying anesthesia and sleep, the investigators aim to reveal what~     happens in the brain when consciousness is lost and when it returns. During the study, a~     series of Positron Emission Tomography (PET), Magnetic Resonance Imaging (MRI) and~     electroencephalography (EEG) studies will be carried out on healthy male subjects to reveal~     the neural correlates of consciousness. Consciousness of the subjects will be manipulated~     with normal sleep and anesthetic agents dexmedetomidine and propofol.~      First, various neurophysiological tools to separate consciousness, connectedness and~     responsiveness during normal sleep will be tested. The most suitable methods and subjects~     will be selected and then tested during anesthetic-induced sedation and loss of~     responsiveness (LOR). The anesthetics (dexmedetomidine or propofol) will be administered as~     target-controlled infusions (TCI) with step-wise concentration-increments until LOR is~     detected. Then, TCIs are repeated in the same subjects but adjusted according to the~     individual drug target concentrations sufficient for LOR, and a series of PET perfusion~     imaging measurements will be performed to obtain the brain activity information in various~     states of consciousness. The same subjects will then be imaged with PET for brain activity~     after sleep deprivation (awake), during various sleep stages and immediately after awakening.~     Finally, ten dexmedetomidine subjects will be given the drug once more, and functional MRI~     (fMRI) data will be collected at various states of consciousness before and during verbal and~     nonverbal vocalizations. EEG will be continuously collected in all sessions. The depth of~     anesthesia will be measured using quantitative EEG and bispectral index (BIS) monitoring.~      The results may lead to the discovery of new and better objective indicators of the depth of~     anesthesia and consciousness, and new insights into the understanding of neural mechanisms~     behind drug-induced loss of consciousness and ultimately the mechanisms of action of~     (general) anesthetics as well as consciousness itself.~   "
128227|NCT01888991|"~     The purpose of this study is to investigate the effect of substrate oxidation, expressed by~     RER, on food intake regulation and net energy balance.~   "
128228|NCT01888978|"~     Patient therapy is tailored according to the molecular profile of the patient's tumor.~   "
128265|NCT01888497|"~     This study will examine the next-day residual effects of a nighttime dose of gabapentin 250~     mg, diphenhydramine citrate 76 mg and triazolam 0.5 mg compared to placebo and each other on~     simulated driving performance in normal volunteer subjects. It will also examine other~     measures of next-day performance and next-day sleepiness.~   "
128230|NCT01888952|"~     This is a Phase 0/1 open-label, non-randomized, biomarker and pharmacodynamic study in~     patients with advanced B-cell lymphoid malignancies, including B-cell chronic lymphocytic~     leukemia (CLL), small lymphocytic lymphoma (SLL), acute lymphocytic leukemia (ALL), multiple~     myeloma (MM), Waldenström's macroglobulinemia (WM), mantle cell lymphoma, follicular~     lymphoma, or diffuse large B-cell lymphoma (DLBCL) who have failed at least one prior therapy~     and for whom no standard curative therapy exists. Patients with advanced stage disease are~     those whose disease is resistant or refractory to standard chemotherapy or biological~     therapies.~   "
128231|NCT01888939|"~     Background:~      - Some studies in adults have found that insulin and glucose blood levels are lower when a~     long period of sitting is broken up with walking, compared to sitting without breaks. This~     means that the body can better process sugars when there are walking breaks during the day.~     Researchers want to know if this is also true for children. Some studies have found that~     children s attention and memory might be better after exercise. Researchers want to know if~     short walking breaks have the same effects.~      Objectives:~      - To understand if breaking up sitting with walking helps children s bodies better use sugars~     and improves children s concentration.~      Eligibility:~      - Healthy children ages 7 to 11.~      Design:~        -  Participants will be screened with a physical exam, medical history, exercise test,~          picture vocabulary test, and medical tests including blood tests and X-rays.~        -  Participants will return for two 7-hour visits. In the month before the visits, they~          will wear a physical activity monitor for one week so researchers know how active they~          are. Once they will take the sitting only test and once the sitting breaks test.~        -  During the sitting only test, participants will sit for 3 hours.~        -  During the sitting breaks test, they will sit for 3 hours with 3-minute walking breaks~          every 30 minutes.~        -  Both days, they will drink sugar water. Then the participants will have blood drawn from~          a needle that is kept in place, and they will wear a heart monitor. They will take~          attention and working memory tests on a computer and answer questions about how they~          feel. They will eat a meal at the end of the test day.~   "
128232|NCT01888926|"~     Background:~      - People with dystonia have serious muscle contractions that cause abnormal movements or~     postures. This significantly affects their daily lives. The common type is called organic.~     The other type is psychogenic. People with this type have typical symptoms plus some~     psychological effects. Researchers will look at how rapid transcranial magnetic stimulation~     (rTMS) of the brain combined with stimulation of a nerve affects the ability to detect~     sensations. They will compare the responses of people with different types of dystonia. They~     will also compare the responses of people with dystonia to responses of people without it.~     This study may help us learn more about the nature of different types of dystonia.~      Objectives:~      - To see whether TMS combined with nerve stimulation affects the brain differently in people~     with different types of dystonia and those without dystonia.~      Eligibility:~        -  Individuals at least 18 years old, who are right-handed and have dystonia.~        -  Healthy volunteers at least 18 years old.~      Design:~        -  Participants will have two clinical visits. Each visit will be a few hours long. They~          can be done on the same day.~        -  Participants will be screened with a medical history and physical exam.~        -  Participants will take several sensory tests. For these tests, electrodes will be placed~          on their skin. The participants will feel small electric shocks during some of the~          tests.~        -  Participants will undergo TMS. For 2 minutes, quick electrical currents will pass~          through a wire coil placed on their head. As this happens, researchers will ask the~          participants to move certain muscles.~   "
128233|NCT01888913|"~     Background:~      - We are studying people s psychological experiences and how these relate to the way people~     respond have when they see information communicated in different ways. We are testing~     multiple research questions in this research.~      Objectives:~      - To learn about how to design future research studies. Also to learn about how to best give~     people information about health topics.~      Eligibility:~      - Women with a Body Mass Index of 25 or higher.~      Design:~        -  Before the study visit, participants will answer some questions online about themselves,~          their experiences, and their thoughts about their weight.~        -  During the study visit, participants will watch a short scene from a movie, and then~          answer questions about it.~        -  Participants will have a simulated doctor visit with a computerized, virtual reality~          doctor. They will answer more questions about themselves, their experiences, and their~          thoughts about their weight. Then they will answer questions with researchers.~   "
128234|NCT01888900|"~     Background:~      - Some people who have chronic hepatitis C do not respond to the usual treatment with~     peginterferon and ribavirin. New chronic hepatitis treatments are being developed that may~     work better for different people. The treatments will look at how specific genes interact~     with the drugs. Researchers want to see how well these new drugs work in people whose chronic~     hepatitis C has not responded or only partly responded to the usual treatment drugs.~      Objectives:~      - To compare new treatments for people with chronic hepatitis C.~      Eligibility:~      - Individuals at least 18 years of age who have chronic hepatitis C that has not responded to~     standard treatments.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Liver scans and a biopsy will be taken before the start of~          treatment.~        -  Participants will be separated into two groups. One group will have the new treatment~          drugs (assunaprevir and daclatasvir). The second group will have these two drugs as well~          as peginterferon and ribavirin. All participants will have an initial 4-day hospital~          stay with regular blood tests to see how the start of the treatment works.~        -  The first group will take the new study drug tablets daily for 24 weeks. Those who do~          not respond to this treatment will also start to take peginterferon and ribavirin, and~          the treatment will continue for 24 weeks after starting the additional drugs.~        -  The second group will take all four drugs according to the standard dosing schedule for~          24 weeks.~        -  Treatment will be monitored with frequent blood tests. Liver scans, biopsies, and other~          tests will be performed as directed by the study doctors.~        -  Participants will have 24 weeks of regular followup visits.~   "
128235|NCT01888887|"~     Determine if Cetaphil Daily Facial Cleanser is a contact sensitizer or irritant to the skin~   "
128236|NCT01888874|"~     -  595 patients suffering from active rheumatoid arthritis despite continued treatment with~          methotrexate will be evaluated for improvement of disease activity (efficacy) when~          taking GLPG0634 (3 different doses - 50mg, 100mg and 200mg daily -, each evaluated as QD~          and BID regimen) or matching placebo for 24 weeks.~        -  During the course of the study, patients will also be examined for any side effects that~          may occur (safety and tolerability), and the amount of GLPG0634 present in the blood~          (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of~          action-related parameters in the blood (Pharmacodynamics) will be determined. Also, the~          effects of different doses and dose regiments of GLPG0634 administration on subjects'~          disability, fatigue, and quality of life will be evaluated.~   "
128237|NCT01888861|"~     Increasing Reactive oxygen and nitrogen production occurred simultaneously with decreasing~     serum and intracellular level of antioxidants and enzymes in critical ill patients, which~     result in increasing ventilator dependency and length of stay in intensive care unit and it~     also accelerate organ failures in patients. In this double blind clinical trial, the~     investigators examine effect of alfa-lipoic acid on those patients who admitted to intensive~     care unit that the investigators expect to stay for more than 7 days in this ward and who~     have tube feeding and don't have severe liver and kidney failure, AIDS and hepatitis. After~     randomization of included patients by block randomization the investigators will give~     900mg/day alfa-lipoic acid for ten days to treatment group and identical placebo to control~     group by naso-gastric tube. The purposes of this study are decreasing ventilator dependency~     period, length of stay in ICU, mortality and decelerate of organ failures.~   "
128238|NCT01888848|"~     This study is being conducted to assess the effect of dietary blueberry supplementation on~     cognition and mobility in older adults. It is hypothesized that plant compounds, present in~     blueberries, may improve cognition and mobility by protecting against oxidative stress and~     inflammation.~   "
128239|NCT01888835|"~     The investigators recently conducted a double-blind, randomized controlled trial (n=60) of~     limited duration (12 weeks), and found that compared with placebo, oral mirtazapine, an~     FDA-approved antidepressant, significantly reduced meth use in those receiving mirtazapine,~     as determined by reduction in meth-positive urines. Sexual risk behaviors also declined~     significantly in the mirtazapine arm compared to placebo. Mirtazapine decreased meth use~     despite low adherence: by medical event monitoring system (MEMS) caps, only 48.5% of daily~     doses were taken. All participants received weekly substance use counseling and monthly,~     brief clinician-delivered adherence counseling. The investigators propose expanding upon~     these results by lengthening the treatment period to 24 weeks, with adherence reminders added~     to the counseling, and determining if efficacy is sustained up to 12 weeks after drug~     discontinuation. The sample size for this 9-month study is 120.~   "
128240|NCT01888822|"~     The trial aims to assess the value of two-regimen antibiotic prophylaxis versus placebo in~     elective laparoscopic cholecystectomy.~   "
128241|NCT01888809|"~     This study will evaluate the effectiveness of providing a combination of evidence-based~     behavioral health treatments for mothers who gave birth to their first child prior to the age~     of 21 and who meet eligibility requirements and their children on prevention of child~     maltreatment and promotion of positive socioemotional development.~   "
128242|NCT01888796|"~     Examination of the effect of Linagliptin versus placebo on diastolic function in patients~     with type 2 diabetes mellitus and diastolic dysfunction as assessed by transthoracic~     echocardiography.~      Furthermore the effect on serum levels of NT-pro BNP as a biomarker of heart failure will be~     investigated.~   "
128243|NCT01888783|"~     This study aims to investigate whether two different measures of tactile acuity lead to~     comparable results in patients diagnosed with CRPS Type I of the upper extremity.~     Additionally patients with a neuropathy of the median nerve and healthy controls are~     included.~   "
128244|NCT01888770|"~     The purpose of this study is to investigate whether exposure to hypertensive disorders of~     pregnancy and/or a preterm birth results in alterations in the cardiovascular system during~     infancy.~   "
128245|NCT01888757|"~     This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single~     dose, crossover, oral bioequivalence study.~   "
128246|NCT01888744|"~     The aim of our study is to define the optimal ovarian stimulation protocol concerning PGD and~     for this reason we plan a randomized controlled trial (RCT) comparing gonadotropin-releasing~     hormone (GnRH) agonist protocol versus GnRH antagonist protocol. The follicle stimulating~     hormone (FSH) preparation in both arms will be highly purified FSH (Menopur®).~   "
128247|NCT01888731|"~     This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single~     dose, crossover, oral bioequivalence study.~   "
128248|NCT01888718|"~     To assess the bioequivalence of Fexofenadine Hydrochloride Orally Disintegrating Tablets 30~     mg of Dr. Reddy's Laboratories Limited, India comparing with that of Allegra® (containing~     fexofenadine hydrochloride) Orally Disintegrating Tablets 30 mg of Sanofi - aventis U.S. LLC,~     Bridgewater, NJ 08807 in healthy, adult, human subjects under fasting conditions. To monitor~     adverse events and ensure the safety of subjects.~   "
128249|NCT01888705|"~     Recently, there has been a growing interest in the study of nonlinear dynamics as a~     methodology for complementary analysis to characterize the respiratory pattern. These methods~     are well established in studies of heart rate. The analyzes evaluate complex signals,~     including large-scale fractal correlations and distributions in time series, and can provide~     relevant clinical information.~      Measures such as approximate entropy and sample entropy have shown great potential in the~     evaluation of the complexity of the respiratory system, providing information relevant to the~     understanding of physiological and pathophysiological processes. These measures are based on~     the concept of non-linearity in the presence of a high number of interconnections, resulting~     in the complex behavior exhibited by physiological systems.~      The approximate entropy (ApEn) is related to the amount of clutter, complexity or~     unpredictability of a data series over time. In a complementary way, the sample entropy~     (SampEn), is a far more elaborate than the ApEn, to reduce possible biased estimates due to~     self-similarity.~      A study conducted by our group in asthma patients with different levels of bronchial~     obstruction demonstrated a significant reduction in airflow approximate entropy (ApEnV´) in~     asthmatic subjects. Investigators believe that in COPD, similar to that which occurs in~     asthma disorders that are associated with complex changes in the pathophysiology triggering~     breath control, possibly resulting in changes in air flow (V´).~      Considering the development silent changes of mechanical ventilation in COPD patients and~     its clinical relevance, as well as the difficulty of identifying such changes through~     conventional methods, we observed the need to obtain more detailed information, including the~     complexity of the system breathing for better understanding of factors that contribute to the~     illness.~      In this context, the objectives of this study were: (1) analyze the influence of airway~     obstruction in the complexity of the patterns of airflow in patients with COPD, (2) evaluate~     the diagnostic power of the test in identifying the changes caused by COPD.~   "
128250|NCT01888692|"~     Acknowledging that level I evidence already exists regarding the general beneficial impact on~     FDG PET in the staging and subsequent management of lung cancer the investigators postulate~     that fusing PET/CT data sets with RT CT simulation data sets for adult patients with~     conventionally/clinically assessed stage III non-small cell lung cancer will have a~     significant impact on GTV as well as normal tissue irradiation. This research will also~     estimate inter and intra-observer variability of treatment planning, relative to GTV, between~     and amongst radiation oncologists.~   "
128251|NCT01888679|"~     The purpose of this study is to evaluate and measure the movement of the endotracheal tube~     depending on the type and the amount of movement of the head of the patient intubated using a~     flexible fiberoptic.~   "
128252|NCT01888666|"~     The aim of this study is to evaluate the periodontal effects during rapid palatal expansion~     (RPE) or slow palatal expansion (SPE) and to compare them by means of periodontal indices, in~     order to establish the possible differences and advantages of one of these treatments in~     periodontal terms.~      Materials and methods: 10 patients will selected and submitted to RPE treatment; other 10~     patients will selected and submitted to SPE treatment. The patients will treated with the~     Haas appliance. In both the groups the periodontal clinical indices (plaque index, PI;~     papillary bleeding index, PBI; probing pocket depth, PPD) will collected three times during~     the treatment (before, during and at the end). All measurements will performed by the same~     examiner.~      A descriptive statistical analysis will conducted. The paired samples Student's T test will~     used to evaluate the intra-group differences between t1 and t2. The unpaired samples~     Student's T test will used to evaluate between groups differences at t1 and t2. The~     significance level will set at 95%.~   "
128253|NCT01888653|"~     Emerging research implicates biased attention to threat in the pathophysiology of anxiety~     disorders. Recent findings demonstrate significant associations between attention bias and~     stress vulnerability. This work has motivated the development of a novel therapy,~     attention-bias-modification treatment (ABMT). ABMT is designed to implicitly modify patients'~     biased threat attendance via computerized training protocols. Emerging evidence indicates~     that ABMT is effective in modifying threat-related attention biases and in ameliorating~     anxiety symptoms. However, it is unclear whether ABMT is efficacious for Posttraumatic stress~     disorder (PTSD). The present pilot study is a double blind trial that seeks to examine~     feasibility, acceptability, safety, efficacy, and risk/benefit ratio of ABMT in individuals~     with PTSD. In addition this pilot study seeks to identify specific genes associated with~     anxiety disorders and to examine whether these can predict the success of the ABMT.~   "
128254|NCT01888640|"~     Pain associated with fibromyalgia interferes with daily function, work, and social activities~     resulting in a decreased quality of life. People with fibromyalgia also have a significant~     amount of fatigue and a fear of movement. People with fibromyalgia show enhanced excitability~     of pain neurons in the central nervous system and reduced pain inhibition. Therefore, one of~     the main treatments for patients with fibromyalgia must focus on pain relief to allow the~     person to function more independently both at home and at work. Transcutaneous electrical~     nerve stimulation is used by health professionals to deliver electrical stimulation through~     the skin for pain control. Basic science studies, from the PI's laboratory show that TENS~     activates descending pain inhibitory pathways to inhibit excitability of pain neurons. Thus~     the ideal patient population for the treatment of TENS would be one in which there is~     enhanced central excitability and reduced inhibition; fibromyalgia is such a condition.~      Hypothesis: The investigators hypothesize that application of Transcutaneous Electrical Nerve~     Stimulation (TENS) to patients with fibromyalgia will reduce resting and movement-related~     pain and reduce central excitability by restoring diffuse noxious inhibitory controls (DNIC),~     and that this decrease in pain and/or central excitability will reduce fatigue and fear of~     movement, thereby improving function and quality of life~   "
128255|NCT01888627|"~     The study examine the effectiveness of an integrated care program including therapeutic~     assertive community treatment (ACT) for people with psychotic disorders fulfilling severe and~     persistent mental illness (SPMI, ACCESS-II study).~   "
128256|NCT01888614|"~     The investigators propose to evaluate etCO in patients with HbSS, HbSC, and HbS-beta~     thalassemia during routine clinic visits, and longitudinally. Our goal is to know whether~     etCO differs amongst subjects with different sickle cell syndrome genotypes, and whether it~     is a stable marker of hemolytic rate, as reflected in routine labs obtained for clinical care~     (including total hemoglobin, reticulocyte count, lactate dehydrogenase, and, when sampled,~     total and direct bilirubin). We hope to establish whether this inexpensive and non-invasive~     test faithfully reflects hemolytic parameters in sickle cell syndromes.~   "
128257|NCT01888601|"~     To study the NSCLC evolutionary genomic landscape between primary and metastatic sites and~     the dynamics of intratumour heterogeneity over time combined with detailed clinical,~     histopathological and cancer phenotypic annotation for each patient, in order to~     significantly improve the outcomes of NSCLC patients (e.g. reduce their chance of recurrence~     and improve survival).~   "
128258|NCT01888588|"~     The analyses are conducted in a previous population-based cohort study using The Health~     Improvement Network database in the UK (Cai et al 2009).The aims of the post hoc analyses~     are:~      To estimate the relative risk of uncomplicated symptomatic peptic ulcer (UPU) associated with~     use of low dose aspirin (ASA) and other anti-inflammatory drugs (NSAIDs, steroids) in the~     general population To estimate the dose-response and duration-response associated with use of~     these drugs To estimate the relative risk of UPU associated with naive/non-naive use of low~     dose ASA in the general population To evaluate the effect of proton pump inhibitors (PPI)~     (alone or in combination with anti-inflammatory drugs) on the occurrence of UPU in the~     general population To investigate the management of low dose ASA/oral antiplatelets after UPU~   "
128259|NCT01888575|"~     This study is conducted in a cohort of low dose aspirin (ASA) users previously ascertained~     .The aims of the post hoc analyses are:~      To estimate the one year risk of discontinuation of use of low-dose ASA associated to PPI~     concomitant use versus non-use, crude and adjusted by confounding.~      To estimate the one year risk of discontinuation of use of low-dose ASA associated to PPI~     concomitant use stratified by age and sex.~      To evaluate other predictors of discontinuation of low-dose ASA during the first year of ASA~     therapy.~   "
128260|NCT01888562|"~     To test the patient's cancerous tumor to see if it has a FGFR mutation and, if so, to see how~     their cancer responds to a treatment with the drug ponatinib as well as examine the side~     effects caused by ponatinib.~   "
128261|NCT01888549|"~     Efficacy of proton pump inhibitor for chronic cough caused by gastroesophageal reflux;~     double-blind, placebo-controlled, randomized clinical trial~   "
128262|NCT01888536|"~     This trial is a comparative study of Opast tablet and Rikalin capsule 75mg and Rikalin~     capsule 75mg in combination with Opast tablet to evaluate improvement effectiveness of Opast~     tablet on subjective symptoms and neurologic claudication in patients with lumbar spinal~     stenosis.~   "
128263|NCT01888523|"~     Determine the efficacy of a brief and inexpensive psychosocial intervention, (called~     expressive writing) in improving health outcomes for cancer survivors.~   "
128268|NCT01888458|"~     Infections due to post transplant immune deficiency are a major problem following allogeneic~     stem cell transplantation (Allo-SCT), particularly in patients receiving cord blood~     transplant (CB). Duration of neutropenia is one of the most important risk factor for~     invasive fungal infection (IFI). In this setting, Micafungin has been approved for antifungal~     prophylaxis for patients undergoing Allo-SCT. In a randomized, double-blind, comparative,~     phase III trial, the overall efficacy of micafungin was superior to that of fluconazole as~     antifungal prophylaxis during the neutropenic phase after Allo-SCT. However, very few~     patients in this study received a CB transplant.~      This is phase IIb, prospective, open-label, non-comparative study to assess the safety of~     micafungin when use in prevention of IFI in neutropenic patients receiving allo-SCT using CB~     as source of stem cells.~   "
128269|NCT01888445|"~     This study is to evaluate safety and efficacy of intermittent oral dosing of ASP1517 in~     dialysis chronic kidney disease patients with anemia.~   "
128270|NCT01888432|"~     The purpose of this trial is to demonstrate the efficacy and safety of everolimus in~     combination with reduced tacrolimus, compared to tacrolimus control, in living donor liver~     transplant recipients.~   "
128271|NCT01888419|"~     Background~      In Denmark, breast cancer is the most common fatal cancer in women with more than 4700 new~     cases annually. Unfortunately, up to 60% of women who are treated surgically for breast~     cancer, will experience chronic pain as a consequence of the treatment. This state of chronic~     neuropathic pain is termed Post Breast Therapy Pain Syndrome or PBTPS.~      The purpose of the study~      The purpose of this study is to investigate whether transplantation of fat cells~     (lipotransplantation) to the pain affected mastectomy area, could have an analgesic effect in~     women who have developed PBTPS. Secondary, we wish to investigate if lipotransplantation has~     a beneficial effect on the quality of the skin and the scar in the area where the~     transplanted fat cells are placed.~      Hypotheses~        -  Lipotransplantation to the area under the scar tissue and the area under the~          pain-afflicted area reduces the pain in women with PBTPS.~        -  The neuropathic pain in PBTPS is correlated to the number of free nerve endings crossing~          the border between the dermis and the epidermis~        -  Lipotransplantation have a beneficial effect on the scar tissue structure and improves~          the skin quality.~      Patients~      Women who have undergone treatment for breast cancer and subsequently developed PBTPS. A~     total of 32 patients with PBTPS will be included.~      Methods~      Patients will be randomly assigned to receive either lipotransplantation or no active~     treatment. At three follow-up visits, the perceived pain of the patient and the skin and scar~     quality will be scored. In addition, a 3-mm biopsy will be taken from the skin on both the~     missing and the healthy breast, and from the mastectomy scar.~      The scoring of the perceived pain and the quality of the skin and the scar, allows us to~     investigate if the lipotransplantation have an effect on pain, and skin/scar quality.~     Additionally, the skin and scar biopsies will be examined on a microscopic level, in order to~     investigate why lipotransplantation has these effects.~      Conclusion~      In summary, the results of this project could help to increase our understanding of why some~     patients develop chronic neuropathic pain after mastectomy and radiotherapy. It is our hope~     that our results may contribute to the development of better and more effective treatment~     that will be beneficial for the project participants and future patients.~   "
128272|NCT01888406|"~     BEST4US compares the effectiveness of two forms of self-help interventions that target~     college students, ages 18 years to 22 years, who report binge eating. The overall question is~     whether one or the other format will prevent excess weight gain and lead to differences in~     eating behaviors. The two formats are (1) pure self-help (receipt of a self-help program~     via book form or online texts) and (2) a combination of the self-help program and guidance~     provided by a trained peer coach over the course of 8 weekly sessions.~   "
128273|NCT01888393|"~     This study is designed to evaluate the pharmacokinetics (PK) and safety of multiple doses of~     lumacaftor in combination with ivacaftor in subjects with moderate hepatic impairment.~   "
128274|NCT01888380|"~     In light of declining autopsy rates around the world, post-mortem MR imaging is a promising~     alternative to conventional autopsy in the investigation of infant death. A major drawback of~     this non-invasive autopsy approach is the fact that histopathological and microbiological~     examination of the tissue is not possible. The objective of this prospective study is to~     compare the performance of minimally invasive, virtual autopsy, including CT-guided biopsy,~     with conventional autopsy procedures in a paediatric population.~      Foetuses, newborns, infants and children that are referred for autopsy at three different~     institutions associated with the University of Zurich will be eligible for recruitment. All~     bodies will be examined with a commercial CT and a 3 Tesla MRI scanner, and investigators~     will be blinded to the results of conventional autopsy. After cross-sectional imaging,~     CT-guided tissue sampling will be performed by a multifunctional robotic system (Virtobot)~     allowing for automated post-mortem biopsies. Virtual autopsy results will be classified with~     regards to the likely final diagnosis and major pathological findings and compared to the~     results of conventional autopsy, which remains the diagnostic gold standard.~      This interdisciplinary study will determine whether virtual autopsy will narrow the gap in~     information between non-invasive and traditional autopsy procedures.~   "
128275|NCT01888367|"~     This is a randomized, blinded, placebo and standard of care controlled study of the efficacy~     of a novel antibiotic containing gel compared to placebo gel in preventing surgical site~     infection after abdominal surgery. patients will be randomized to active or placebo gel in a~     double-blind manner. The gel will be applied a single time in the incision during closure at~     the end of surgery. A cohort of patients will also be randomized to standard of care, saline~     irrigation at prior to skin closure, in an open manner. The efficacy, safety and tolerability~     of the active gel will be assessed compared to the control group (combined placebo gel and~     standard of care groups). Patients will be randomized to DFA-02 active gel: placebo gel:~     standard of care in a 4:1:1 ratio.~   "
128276|NCT01888354|"~     This pilot study is designed as a prospective cohort study to determine whether standard~     subcutaneous (SQ) Highly-Purified (HP) Acthar Gel 14 days is superior to SQ HP Acthar Gel 5~     days in the treatment of relapses or attacks in multiple sclerosis (MS).~   "
128277|NCT01888341|"~     The purpose of this study is to determine the pharmacokinetics and bioequivalence of~     isotretinoin formulations after administration of single doses to normal, non-smoking,healthy~     males under fasting conditions~   "
128278|NCT01888328|"~     The purpose of this study is to determine the pharmacokinetics and bioequivalence of~     isotretinoin formulations after administration of single doses to normal, non-smoking,healthy~     males under fed conditions~   "
128279|NCT01888315|"~     The study is aiming to document the long-term safety and effectiveness of renal denervation~     in patients with hypertension and other diseases characterized by elevated sympathetic drive.~     Catheter-based renal denervation will be performed using CE marked, percutaneous, systems.~   "
128300|NCT01888042|"~     It is a an open label, multicentric, phase II study assessing the efficacy of everolimus~     (given per os) as a first line treatment in kidney cancer of bad prognosis.~      92 patients will be included (anticipated). The treatment by everolimus will continue until~     progression, significant toxicity or withdraw of consent~   "
128280|NCT01888302|"~     This pilot phase I trial studies the side effects and best way to give sirolimus, gemcitabine~     hydrochloride, and cisplatin in treating patients at high risk for cholangiocarcinoma~     recurrence after liver transplant or surgery. Sirolimus may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as~     gemcitabine hydrochloride, and cisplatin, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving sirolimus with~     gemcitabine hydrochloride and cisplatin may prevent disease recurrence in patients with a~     high risk of recurrence after a liver transplant or surgery.~   "
128281|NCT01888289|"~     The purpose of this study is to determine the pharmacokinetics and bioequivalence of~     isotretinoin formulations after administration of single doses to normal, non-smoking,healthy~     males under fasting conditions~   "
128282|NCT01888276|"~     The pathophysiology of compulsive disorders as gambling could be close to behavior problems~     encountered in Parkinson's disease associated with a hyperactivity of the motivational~     system.~      Thanks to the words generation test, which reflects the cortico-subcortical loop functioning,~     involved in motivation, we want to evaluate and compare using tools (words generation and~     behavioral tests) the motivational functioning of gamblers and healthy volunteers that we can~     then compare to that of Parkinson's patients with and without behavioral hyperdopaminergic~     disorders which were explored in another study.~   "
128283|NCT01888263|"~     This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single~     dose, crossover, oral bioequivalence study.~   "
128284|NCT01888250|"~     This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single~     dose, crossover, oral bioequivalence study.~   "
128285|NCT01888237|"~     The purpose of this study is to compare the efficacy between 1-day high dose PPI-based triple~     therapy vs. 10-day sequential therapy for Helicobacter pylori eradication in functional~     dyspepsia patients.~   "
128286|NCT01888224|"~     To characterise the pharmacokinetic profile of sponsor's test formulation Isotretinoin~     Capsules 40 mg in comparison to the reference formulation Amnesteem (Containing Isotretinoin)~     Capsules 40 mg after single oral dose administration to healthy, normal, adult, human male~     subjects under fed condition.~   "
128287|NCT01888211|"~     The mechanisms through which omega-3 fatty acids reduce adverse cardiac events remain~     uncertain. The aim of the study was to investigate the effect of omega-3 fatty acid~     supplementation on endothelial vasomotor function, endogenous fibrinolysis, and platelet and~     monocyte activation in patients with coronary heart disease.~   "
128288|NCT01888198|"~     The purpose of this study is to better understand how effective ablation is for destroying~     tumor cells in the kidney and whether quality of life is improved for patients. Participation~     in ARMOR may involve retrospective data collection only, combined retrospective and~     prospective data collection, or prospective data collection~   "
128289|NCT01888185|"~     This study is designed to determine if magnetic resonance imaging (MRI) measures can be used~     to diagnose and monitor the progression of Parkinson's disease (PD) while distinguishing~     between PD and parkinsonisms [conditions that are PD look-a-like diseases such as progressive~     supranuclear palsy (PSP) or multiple system atrophy (MSA)] when combined with changes in~     certain proteins in body fluids that are related to iron (Fe).~   "
128290|NCT01888172|"~     The purpose of this study is to conduct a randomized controlled trial to compare the weight~     losses produced by the Weight Watchers Online program (WWO) and WWO plus the Philips~     ActiveLink physical activity system, over a 1-year period, compared to a control group.~   "
128291|NCT01888159|"~     Randomised study to investigate if salpingectomies done to women wishing tubal sterilisation~     has an effect on ovarian reserve.~   "
128292|NCT01888146|"~     The overall aim of this study is to adopt an integrative rehabilitation approach for helping~     patients adopt self-management skills for managing chronic pain, limiting use of opioid~     medications, and identifying exacerbating factors amenable to treatment (e.g., depression,~     sleep problems) that is feasible and sustainable within the primary care setting.~   "
128293|NCT01888133|"~     Can participation in group physical activity, such as a community-based organized group walk,~     help adult diabetes patients develop a physically active lifestyle? Can such engagement~     ultimately lead to an improvement in hemoglobin A1c? To address this question, the~     investigators have designed this pilot study with the aim to investigate the effect of~     community-based group walks among Joslin adults with diabetes on the development of a~     physically active lifestyle and glycemic level. The investigators hypothesize that~     participation in group walking events helps Joslin adults with diabetes engage in physical~     activity and improves glycemic control.~   "
128294|NCT01888120|"~     The objectives of this study are to evaluate the effectiveness, long-term safety,~     tolerability, satisfaction with treatment, and health-related quality of life (HRQoL)~     associated with Intrathecal PRIALT use for severe chronic pain of varying etiologies.~   "
128295|NCT01888107|"~     The purpose of this study is to assess the maintenance of antipsychotic efficacy and safety~     of risperidone long-acting injectable (RLAI) in patients with schizophrenia (psychiatric~     disorder with symptoms of emotional instability, detachment from reality, often with~     delusions and hallucinations, and withdrawal into the self) or schizoaffective (a mixed~     psychiatric disorder relating to a complex psychotic state that has features of both~     schizophrenia and a mood disorder such as bipolar disorder) disorder who were receiving~     treatment with any antipsychotic medication and who required a long-term antipsychotic~     therapy. The secondary aim is to investigate prospectively (a study that starts with the~     present condition of a population of individuals and follows them into the future) the~     prevalence of patients who met standardized remission criteria (according to Andreasen et al.~     criteria) and the psychopathological, psychosocial and subjective predictors of achieving~     remission.~   "
128296|NCT01888094|"~     Prospective, randomized controlled clinical unicentric study, in ICU, Cannulation of the~     subclavian venous and examination guided with ultrasound~   "
128297|NCT01888081|"~     The purpose of this trial is to study A-dmDT390-bisFv(UCHT1) in combination with ionizing~     irradiation for the treatment of stage IV melanoma, a disease that is essentially incurable~     with median overall survival periods that range from 8-16 months.~   "
128303|NCT01888003|"~     The goal of this study is to gain further insight into the comparative effectiveness of~     treating patients, who are found to be anemic before their elective surgery, with a series of~     weekly subcutaneous doses of a drug given before surgery, which stimulates the natural~     production of red blood cells (a so-called erythropoietic stimulating agent [ESA]) along with~     intravenous iron, in reducing the need for blood transfusions (donated by someone other than~     the patient) during and after adult total hip arthroplasty (hip replacement surgery). The~     effects of a Preoperative Anemia Management Program (PAMP) on the patient's quality of~     recovery, health-related quality of life, fatigue, and rehabilitation pattern after surgery~     will also be examined. A cost-effectiveness analysis will be performed to compare the cost of~     these commercially available, FDA-approved medications versus the cost of transfused blood~   "
128304|NCT01887990|"~     This study is dedicated to achieving better treatments for suicidal thoughts. Specifically,~     the investigators are studying the effect of a medication called ketamine to quickly treat~     suicidal thoughts and depression.~   "
128305|NCT01887977|"~     A computational model of human sound production based on high quality anatomic measurements~     and physical laws of sound propagation cannot be accomplished without a comprehensive data~     set including both 3D-images of the speaker's anatomy and the simultaneous recording of~     speech. Since the computational model has separate models for the vocal folds and the vocal~     tract, patients undergoing an orthognathic surgery is an optimal test object for the model~     development. Vocal folds remain unchanged while substantial changes take place in the vocal~     tract. Moreover, since the aim of the research is to predict acoustic changes in speech due~     to operations in head neck area, the orthognathic patient group is par excellence an example~     of such a prediction problem. If the model can be shown to give valuable information~     pre-operationally, many other patient groups could benefit from the results.~   "
128306|NCT01887964|"~     Metabolic syndrome is a condition characterized by excess body weight, large waist~     circumference, high cholesterol and glucose in the blood, and hypertension. People with~     metabolic syndrome are at increased risk for heart diseases. Research shows benefits of~     regular fiber intake in metabolic syndrome. However, due to altered taste and texture of the~     high fiber foods, long term intake of fiber is a challenge for metabolic syndrome patients.~     This study is designed to find if blinded-substitution of regular wheat flour in domestic~     kitchen with wheat flour enriched by an adaptable type of fiber (resistant starch-4),~     minimizes metabolic syndrome symptoms. this special type of fiber is also obtained from~     wheat.~   "
128307|NCT01887951|"~     Introduction~      Current practice in Singapore Emergency Ambulance Service (EAS) includes the use of analgesia~     delivered via inhalation Enthanox (Nitrous Oxide). However there are difficulties~     administering Enthanox on-scene due to the added weight of carrying bulky cylinder tanks. It~     is common for a delay in administration of analgesia. Inhaled methoxyflurane (Penthrox) is a~     potential agent for early administration of analgesia by Singapore Civil Defense Force (SCDF)~     EAS. It is extensively used in the pre-hospital setting in Australia. However data on its use~     as an analgesic agent in general are limited and there are few published controlled trials of~     methoxyflurane in an analgesic role. Intramuscular (IM) tramadol is a common medication used~     in the hospital setting for analgesia. It is well proven, simple to deliver and is not a~     controlled drug.~      Aim~      To compare Penthrox and Tramadol in the treatment of acute pain in patients transported by~     the SCDF EAS.~      Methodology~      The trial will recruit 400 eligible patients over 1 year (200 Penthrox and 200 tramadol).~     Patients managed by SCDF EAS for treatment of acute pain and who meet the eligibility~     criteria will be recruited into the study. Half of SCDF's 30 ambulances (15 ambulances), will~     be randomly assigned, equipped and trained to carry the new medication (Penthrox). The other~     half (15 ambulances), will be trained and equipped with tramadol. Allocation will be on a per~     station level. After 6 months, they will cross over to Penthrox and tramadol respectively.~      All paramedics will be trained to use both medications, pain scales and Ramsey scores, and~     will record patient's pain, sedation scores and patient satisfaction as part of routine~     clinical practice. All patients will be followed up by a review of their Emergency Department~     and hospital records for any medication related adverse effects.~      Hypothesis~      The investigators hypothesize that in patients with acute pain (pain score ≥3), presenting to~     the ambulance service with musculo-skeletal trauma (limbs or back); pain relief by inhaled~     methoxyflurane will be equivalent to IM tramadol, as assessed by Visual Analogue Scale (VAS)~     at 5, 10, 15 and 20 min after start of the study treatments.~   "
128308|NCT01887938|"~     The purpose of this study is to collect long-term safety data in patients with metachromatic~     leukodystrophy (MLD) who are receiving HGT-1110 and have participated in Study HGT-MLD-070~     through Week 40.~   "
128309|NCT01887925|"~     The purpose of this study is the evaluation of effect of circadian gene on sleep and other~     symptoms in breast cancer patients under chemotherapy.~   "
128310|NCT01887912|"~     The aim of this study is to evaluate the efficacy of the candidate Clostridium difficile~     vaccine to prevent primary symptomatic C. difficile infection (CDI) in subjects a risk for~     CDI where there is a substantial unmet medical need.~      Primary objective:~        -  To assess the efficacy of the C. difficile vaccine in preventing the onset of~          symptomatic primary CDI confirmed by polymerase chain reaction (PCR) in adult subjects~          aged ≥ 50 years who are at risk for CDI and have received at least 1 injection.~      Secondary Objectives:~      Efficacy:~        -  To assess prevention of symptomatic PCR-confirmed primary CDI cases after 3 injections~          administered at 0, 7, and 30 days~        -  To assess prevention of symptomatic PCR-confirmed primary CDI cases after completion of~          at least 2 injections.~      Immunogenicity:~        -  To describe the immunogenicity to toxin A and toxin B in the subset of subjects at~          specific time points.~      Safety:~        -  To describe the safety profile of all subjects who receive at least 1 injection.~   "
128311|NCT01887899|"~     The aim of this study is to investigate whether the anodal transcranial direct current~     stimulation (tDCS) over the primary motor cortex (M1) in patients with dementia of the~     Alzheimer type (DAT) leads to an increase in cortical plasticity (change in motor evoked~     potentials (MEP) in mV).~   "
128312|NCT01887886|"~     This multicenter, randomized, double-blind, placebo-controlled study will evaluate the safety~     and efficacy of onartuzumab in combination with erlotinib in patients with previously~     untreated, unresectable stage IIIB or IV non-small cell lung cancer identified to carry and~     activating EGFR mutation and MET-positive. Patients will be randomized to receive either~     onartuzumab 15 mg/kg intravenously every 3 weeks in combination with erlotinib 150 mg orally~     daily or placebo in combination with erlotinib. Anticipated time on study treatment is until~     disease progression or unacceptable toxicity occurs.~   "
128338|NCT01887548|"~     Quality of life is recommended as one of essential parameters to evaluate treatment effect~     and clinical outcome in patients with Crohn's disease (CD). Recent studies reported that~     several disease-unrelated variables may affect quality of life in CD patients. This study is~     dedicated to investigate the influence of various personality traits on quality of life, and~     whether or not they should be taken into account when evaluating clinical outcomes in~     patients with CD.~   "
128313|NCT01887873|"~     The study is designed to assess the safety of Hyaluronan Thiomer i.o. implant in patients~     with primary open angle glaucoma undergoing a combined phacoemulsification - non penetrating~     deep sclerectomy procedure.~      In this study, Hyaluronan Thiomer i.o. will be implanted during a combined surgery of~     cataract and non - penetrating deep sclerectomy in a group of 16 patients with primary open~     angle glaucoma and clinically significant cataract. Given that a considerable number of~     glaucoma patients also suffer from cataract, it is reasonable to test Hyaluronan Thiomer i.o.~     during a combined procedure of phacoemulsification and deep sclerectomy. This is also of~     importance because a combined procedure avoids the need of a second operation in this group~     of patients. Finally, it has been shown that combined phacoemulsification - deep sclerectomy~     does not induce a further risk compared to deep sclerectomy alone(open phase I study).~      Safety will be assessed based on the occurrence of adverse events.~      Efficacy assessments will be performed at every visit and efficacy analysis will include:~        -  Proportion of subjects at each study time point which will need additional IOP lowering~          drug therapy to achieve an IOP reduction to values < 21 mmHg. If a subject needs more~          than one drug to achieve target IOP, the number of drugs needed to achieve adequate IOP~          reduction will be recorded.~        -  Proportion of subjects at each time point which will need Neodymium:YAG goniopuncture to~          achieve an IOP reduction to values < 21 mmHg.~   "
128314|NCT01887860|"~     Determine if Cetaphil Daily Facial Moisturizer SPF 50 proves to be a contact sensitizer or~     irritant in certain individuals.~   "
128315|NCT01887847|"~     The objective of this study is to compare the pharmacokinetics of an investigational 2 mg~     sublingual nicotine tablet (Pharmaceutical Productions Inc.) to a 2 mg Commit® nicotine~     lozenge (GlaxoSmith Kline) in a randomized crossover design in 6 male and female otherwise~     healthy smokers.~   "
128316|NCT01887834|"~     The Canadian College of Naturopathic Medicine is conducting a research study on Irritable~     Bowel Syndrome (IBS), a common condition in North America. It is a long term, recurring~     gastrointestinal disorder that is estimated to affect 30% of the general population. IBS is~     characterized by abdominal pain and cramps, and bowel dysfunction such as diarrhea and~     bloating.~      The medicines that are currently used to help people with IBS are not as effective as we~     would like them to be. These medicines are usually only prescribed to reduce the pain of IBS~     and not actually treat the disorder itself. Recently, scientists have found that probiotics~     (beneficial bacteria that live inside humans) may help reduce the painful symptoms and~     diarrhea that are part of IBS.~      This research is being conducted to determine whether this particular combination of three~     probiotic bacteria (named Lactobacillus gasseri, Bifidobacterium bifidum and Bifidobacterium~     longum) will reduce the symptoms of severe IBS.~   "
128317|NCT01887821|"~     This is a study of drug effectiveness for 2 treatments of vivax malaria, which is one of the~     two main types of malaria in Viet Nam. There are two important drugs used in Viet Nam for~     treating vivax malaria, Chloroquine and Artemisinin. Sometimes, when medicines are used for~     many years they become less effective at treating a disease, especially when they are not~     used at adequate doses according to national guidelines or when counterfeit drugs are~     available in the market. The purpose of this study is to check that Chloroquine and~     Artemisinin, are still effective for patients in Viet Nam.~      Participants in this study will be treated with either Dihydroartemisinin-Piperaquine~     (DHA-PPQ) or Chloroquine (CQ) for 3 days. Both drugs are recommended by the national~     guidelines to treat vivax malaria. The investigators would like to know if both of these~     treatments are equally effective so half of the patients in the study will be treated with~     DHA-PPQ and the other half will be treated with CQ. This way the investigators can compare~     the drugs to find out if one is better than the other.~      Participants will be followed for 3 days in hospital, then regularly by follow-up visits~     until the 63rd day. Tests will be done to determine the amount of drug and malaria parasites~     in the participant's body and how the blood cells react to the malaria. The parasite will be~     tested to determine what type it is and how it reacts to the treatment.~      The results of the study will be used to inform malaria treatment guidelines in Viet Nam.~   "
128318|NCT01887808|"~     Determine if Cetaphil DermaControl Oil Control Moisturizer SPF 30 proves to be a contact~     sensitizer or irritant in certain individuals~   "
128319|NCT01887795|"~     1. Verify the effect of Erlotinib concurrent whole-brain radiation therapy as ﬁrst-line~          treatment for patients with multiple brain metastases from non-small-cell lung cancer to~          compare with WBRT alone.~        2. Verify pre-built EGFR mutation prediction model for NSCLC brain metastases~   "
128320|NCT01887782|"~     This trial will compare a novel form of rTMS, intermittent Theta Burst Stimulation to the~     standard conventional high frequency left sided stimulation protocol. The Left dorsolateral~     prefrontal cortex will be the site of stimulation in both treatment conditions. The site of~     stimulation will be targeted using MRI co-registration. The study seeks to determine if the~     two treatment protocols have similar effectiveness in treating major depression.~   "
128321|NCT01887769|"~     Rationale: With 1.6 million new cases diagnosed each year and 1.3 million deaths, lung cancer~     is the leading cancer-related death worldwide and it represents a pressing health issue.~     Patients with lung cancer are more likely to experience cachexia, a severe debilitating~     disorder causing fatigue, weight loss, muscle wasting and associated with reduced physical~     function, increased chemotherapy toxicity and reduced survival. This syndrome occurring in~     about 80% of advanced cancer patients is the direct cause of death in about 20% of cases.~     However, despite the importance of cachexia in lung cancer, it has been mainly studied from~     several assessment methods which do not usually differentiate muscle from other tissues.~      Aim: To analyze body composition of patients with lung cancer at diagnosis using computed~     tomography (CT-Scan) image analysis.~      Methods: This is a retrospective study extending over a period of 3 years conducted at the~     Institut universitaire de cardiologie et de pneumologie de Québec (2009-2012). We listed~     patients newly diagnosed with lung cancer who had a thoraco-abdominal CT-scan performed in~     our institution. Following the collection of clinical data from patient records, we used~     SliceOmatic software to quantify muscle area, visceral fat area and subcutaneous fat area~     from a single abdominal cross-sectional image at the level of the third lumbar vertebra.~   "
128339|NCT01887535|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and~     pharmacodynamics of multiple-ascending dose JNJ-54861911 which is currently being developed~     for the treatment of Alzheimer's disease.~   "
128322|NCT01887756|"~     Telerehabilitation refers to the use of Information and Communication Technologies (ICT) to~     provide rehabilitation services to people remotely in their homes or other environments. By~     using ICT, patient access to care can be improved and the reach of clinicians can extend~     beyond the physical walls of a traditional healthcare facility, thus expanding continuity of~     care to persons with disabling conditions. The concept of telecare, when telerehabilitation~     is used to deliver services to patients in their homes or other living environments, empowers~     and enables individuals to take control of the management of their medical needs and~     interventions by enabling personalized care, choice and personal control Research Goal and~     Objectives~        1. To investigate the clinical feasibility and usability of the Gertner Tele-Motion-Rehab~          system in post-stroke patients, in their homes.~        2. To evaluate Gertner Tele-Motion-Rehab system clinical improvement within the patient's~          home in terms of:~             1. function of the weak upper extremity~             2. performance of ADL~   "
128323|NCT01887743|"~     The World Health Organization has declared childhood obesity to be one of the most serious~     public health challenges of the 21st century,~     (http://www.who.int/dietphysicalactivity/childhood). Given that obese children are generally~     excluded from clinical trials, little to no information exists regarding the impact of~     obesity on drug disposition and drug action, creating a gap in physicians' knowledge on how~     to appropriately select the dose of many critical medications (e.g., anticancer agents), so~     as to prevent toxicity associated with overdosing, while avoiding the harms of~     under-treatment. The proposed study will examine the effect of obesity on the metabolism of a~     commonly used medication, the proton pump inhibitor pantoprazole, by exploring the~     relationships between age, obesity, basal metabolic rate and genetic control of the enzyme~     primarily responsible for pantoprazole metabolism. We will also validate a simple breath test~     that can be used to predict pantoprazole dose requirement for obese children.~      The study is designed to test the following experimental hypotheses:[13C]-pantoprazole~     pharmacokinetic parameters are not different between non-obese and obese children and~     adolescents, collectively (both age groups combined) or stratified by age group (SA 1)~     [13C]-pantoprazole pharmacokinetic parameters or DOB values (and thus, CYP2C19 activity) are~     not different between males and females (SA 1 & 2) [13C]-pantoprazole pharmacokinetic~     parameters and DOB (Delta over baseline) values (and thus, CYP2C19 activity) are independent~     of age over the age range of 6 to 17 years (SA 1 & 2) Obesity does not alter the relative~     contributions of CYP2C19-dependent and non-CYP2C19-dependent (i.e., CYP3A4) metabolism of~     pantoprazole, as measured by the urinary ratio of 4-hydroxy-pantoprazole to pantoprazole~     sulfone (SA 1 & 2) The [13C]-pantoprazole breath test, by determining DOB at discrete time~     point(s), is a non-invasive measure of CYP2C19 phenotype (SA 2) Clearance of pantoprazole~     (surrogate for CYP2C19 activity) is a function of REE in obese and non-obese children and~     adolescents (SA 3) Pantoprazole clearance (surrogate for CYP2C19 activity) is associated with~     fat distribution, as determined by waist-to-hip ratios (SA 3)~   "
128324|NCT01887730|"~     In this study the investigators aim to elucidate the possibility to reduce occurrence of~     infectious diseases in a garrison with enhanced and guided hand hygiene. The investigators~     will study occurrence and transmission of infections. In addition, the investigators will~     find out the causative agents of infections in a garrison with virological analyses of~     naso-pharyngeal and fecal specimens. The costs of lost service days and other expenses due to~     infectious diseases will be evaluated with a cost analysis study.~   "
128325|NCT01887717|"~     This is a two-arm, open-label, prospective, multi-center, randomized, active-controlled~     clinical trial to assess efficacy and safety of TheraSphere in comparison to standard of care~     therapy (sorafenib) in the treatment of patients with inoperable liver cancer and blockage of~     the portal vein.~   "
128326|NCT01887704|"~     The optimal treatment of calcified coronary lesion remained to be elucidated. A Prospective,~     randomized controlled trial was perform to explore the immediate effect and long-term outcome~     of rotational atherectomy in patients with balloon resistant coronary lesion.~   "
128327|NCT01887691|"~     The purpose of this study is to examine the influence of sleep effectiveness on glucose and~     insulin metabolism in health and disease (prediabetes and type two diabetes).~      We will monitor sleep effectiveness using the sleep spectrogram, obtain serial nocturnal~     blood glucose and insulin measurements, and assess the impact of pharmacologic enhancement~     [using eszopiclon (Lunesta), a medication that promotes stable sleep)] on glucose and insulin~     homeostasis.~      We hypothesize that 1: Effective sleep is associated with enhanced insulin sensitivity,~     relative to ineffective sleep states, and 2: Enhancing sleep effectiveness using eszopiclone~     (Lunesta) improves 24-hour glucose metabolism in prediabetics and diabetics compared to~     baseline.~   "
128328|NCT01887678|"~     The aim of this study is to evaluate the effectiveness and safety of a combined Traumeel® /~     Zeel® injection against placebo (saline) in patients with moderate-to-severe pain associated~     with osteoarthritis of the knee.~   "
128329|NCT01887665|"~     The clinical trial portion of this study tests the hypothesis that contingency~     management-based incentives for primary care patients with substance use disorders to attend~     treatment services will increase treatment initiation and engagement. The investigators are~     investigating whether this approach that has been found effective in specialty treatment~     settings will work in the primary care context, in conjunction with screening.~   "
128330|NCT01887652|"~     The purpose oh the study is to determine the usefulness of anti-Mullerian hormone (AMH) to~     identify women at risk of excessive and poor response in controlled ovarian stimulation (COS)~     for in vitro fertilization (IVF), and the clinical impact of applying individualized COS~     strategies in these subsets of patients.~   "
128331|NCT01887639|"~     A non interventional, descriptive, longitudinal cohort study is designed, trying to obtain~     local data about the prevalence of non remitted depressed patients after an antidepressant~     treatment, and to get information about sociodemographic and clinical characteristics of~     these patients as well as features of their treatments and compare them with those of the~     patients that achieve remission. Also the effect of patient´s expectation in the treatment~     outcome will be examined.~   "
128332|NCT01887626|"~     Study to investigate if the uptake of Ticagrelor into the body differs depending on method of~     administration.~   "
128333|NCT01887613|"~     This study is to investigate the long-term safety and efficacy and the information on the~     proper use of Regnite® under conditions of daily clinical use.~   "
128334|NCT01887600|"~     This study is conducted to treat anemia in patients with chronic kidney disease. Anemia is a~     reduced number of red blood cells or hemoglobin. Hemoglobin is important for the transport of~     oxygen in your blood. The purpose of the study is to see if Roxadustat is both effective and~     safe as a treatment for anemia in patients with chronic kidney disease.~   "
128335|NCT01887587|"~     This is a phase I study of vincristine, doxorubicin and dexamethasone (modified VXD) plus~     MLN9708 in adults with relapsed or refractory acute lymphoblastic leukemia/lymphoma,~     lymphoblastic lymphoma or mixed phenotype acute leukemia.~   "
128336|NCT01887574|"~     Collect valuable risk factor and quality of life data from Renal Cell Carcinoma patients and~     harness the latest technology to organize and analyze data.~   "
128341|NCT01887509|"~     This innovative study will involve the use of probe-based confocal laser endomicroscopy, a~     new medical imaging technology never used for surgical indications to date. Virtual biopsies~     (pCLE images) will be compared to histopathology analysis.~      This study focuses on the evaluation of rectal tumor margins. The hypothesis is that pCLE~     will allow identification of rectal tumor margin, comparable to that of histopathology. In~     the future, decision of resection margin could rely on intraoperative pCLE exam.~      The proposed study is a feasibility study, first in the indication of rectal cancer.~   "
128342|NCT01887496|"~     Epidemiological information on varicella complications in children is essential for the~     development of appropriate immunization recommendations. Economic analyses of varicella~     immunization are sensitive to the costs of hospitalized cases, so there is a need to validate~     varicella-related hospitalization data in a country-specific manner. These data also provide~     a baseline for comparison with data collected after routine varicella immunization to~     evaluate the overall impact and cost-effectiveness of varicella immunization programs.~     Knowledge about the cause and incidence of varicella-related hospitalizations in Turkey is~     limited, center-specific and not sufficiently accurate. The aim of this multicenter study~     (VARICOMP) was to estimate the annual incidence of pediatric varicella-related~     hospitalization, describe the associated complications and estimate the annual mortality and~     economic cost of these cases.~   "
128343|NCT01887483|"~     A two month intervention trial assessing the effect of Vetal Laban containing L. acidophilus~     on enhancing functional bowel wellbeing among subjects with irritable bowel syndrome (IBS).~   "
128344|NCT01887470|"~     The purpose of the study is to determine the efficacy of 2 regimens of lactulose as a~     preparation for colonoscopy.~   "
128345|NCT01887457|"~     This is a trial to determine whether giving a patient a tailored dose of voriconazole is safe~     and effective.~   "
128346|NCT01887444|"~     The purpose of this study is to evaluate the efficacy of the oral administration of~     Lactobacillus reuteri in treating infantile colic as defined by the Rome III criteria. Forty~     breastfed infants aged from 29 days to 3 months will be enrolled and blinded randomized to~     receive orally L.reuteri or placebo. The rate of responders (reduction of daily crying time~     >50% compared to the baseline) will be assessed at day 7, day 14 and day 21 in both groups.~     The average daily crying time as well as the associated digestive symptoms will also be~     analyzed.~   "
128347|NCT01887431|"~     The purpose of this study is to determine whether Telecare can be used for efficient~     management of adults with Type 1 Diabetes Mellitus using insulin pump, in lieu of frequent~     clinic visits.~   "
128348|NCT01887418|"~     Relative Bioavailability and Safety comparison of 3 formulations of Testosterone Enanthate.~   "
128349|NCT01887405|"~     The purpose of the study is to demonstrate non-inferiority of Jext compared with EpiPen for~     the proportion of subjects with a successful self-injection. And to evaluate and compare the~     handling characteristics of two auto-injectors (Jext and EpiPen).~   "
128350|NCT01887392|"~     The aim of this study is to disseminate the 2010 Osteoporosis Canada clinical practice~     guidelines, using a multi-faceted Knowledge Translation (KT) model, as KT aims to close the~     gap between knowledge generated from research and practice. The investigators' primary~     objective is to evaluate if this intervention can increase the percent of long-term care~     (LTC) residents receiving appropriate treatment for osteoporosis (i.e. treatment is~     considered appropriate for an individual over age 50 who has had a diagnosis of osteoporosis~     or a fragility fracture of the hip or vertebrae and those who have had more than one~     fragility fracture and is therefore considered high-risk). A secondary objective is to~     examine whether the intervention increases the percent of all LTC residents receiving Vitamin~     D equivalent to ≥800 IU/day.~   "
128351|NCT01887379|"~     Furosemide is a diuretic drug, used in the treatment of oedematous states associated with~     cardiac, renal, and hepatic disorder, and may be effective in patients unresponsive to~     thiazide diuretics. Furosemide is also used in the treatment of hypertension.~      Absorption of furosemide from the gastrointestinal tract is fairly rapid; bioavailability is~     60-70%, but variable and not predictable, with large intra- and inter-individual variability,~     and are influenced by dosage form, underlying diseases, and by the presence of food after~     oral administration. Data from animal model show that furosemide administered into the~     stomach is more rapidly absorbed than if is administered into the small intestine.~      To increase the residency of furosemide in the stomach after oral administration, a~     gastroretentive dosage form (GRDF) of furosemide has been developed. In the current study,~     the new formulation (30mg furosemide coated tablet) will be tested in healthy male subjects.~     Absorption will be characterised by an effective and safe imaging technique - Magnetic Marker~     Monitoring (MMM), based on Fe3O4 added to the drug product to generate magnetic signal that~     can be used for up to 12 h after furosemide administration to localize the medication in the~     gastrointestinal tract. Fe3O4 is frequently used as colouring pigment in medicinal products.~     It does not exhibit own pharmacodynamic activity and is considered as an inactive ingredient.~      In the current study, GRDF formulation of furosemide will be evaluated for: gastric residence~     as well as pharmacokinetic and pharmacodynamic characteristics under fasting and fed~     conditions. As part of the study, the subjects will be hospitalized for 1 day during each~     drug administration. The duration of the stay will depend on the intestinal behaviour of the~     investigational product.~   "
128352|NCT01887366|"~     The primary objective of this study is to assess the efficacy and safety of TV-1380~     [Recombinant human serum albumin (HSA) mutated butyrylcholinesterase (AlbuBChE)] in~     facilitating abstinence in cocaine-dependent subjects.~   "
128353|NCT01887353|"~     The purpose of this study is to evaluate the efficacy of ranolazine in the prevention of~     recurrent atrial fibrillation in post-cardioversion patients with heart failure and preserved~     ejection fraction.~   "
128354|NCT01887340|"~     The purpose of the study is to evaluate the ration of patients getting an lighten therapeutic~     strategy after 18F-fluoro-désoxyglucose positron emission tomography (PET-TDM) in grade I~     (cohort 1) or metastatic (cohort 2) seminoma~   "
128407|NCT01886651|"~     The purpose of this study is to explore the impact of thiopurine methyltransferase (TPMT)~     activity on the risk of HDM-related bone marrow- and hepatotoxicity and treatment~     interruptions during maintenance therapy for children with ALL.~      Hypothesis of the study: Patients with TPMT activity compatible with TPMT low activity~     polymorphisms have an increased risk of toxicity following high-dose methotrexate (HDM)~     compared to children with normal TPMT activity.~   "
128355|NCT01887327|"~     Neonatal jaundice is the most common cause of hospital readmission for term- and near term~     infants and its management poses a significant burden on the healthcare system.~      Infants with isoimmune hemolytic disease, such as ABO or Rhesus (Rh) incompatibility, or~     glucose-6-phosphate dehydrogenase (G6PD deficiency), have an increased rate of red cell~     destruction and, thus, an increase in bilirubin production. Newborn infants have immature~     liver function and do not conjugate bilirubin well, which results in accumulation of~     unconjugated bilirubin. Thus, bilirubin levels may rise rapidly and intervention may be~     required. At present, phototherapy (PT) is the most frequently used treatment for~     hyperbilirubinemia; it converts unconjugated bilirubin to less toxic water soluble~     photoisomers that are then excreted in the urine without need for conjugation. Infants who do~     not respond to PT are treated by exchange transfusion (ET), considered a therapy of last~     resort because of associated morbidity and mortality. Both PT and ET enhance the elimination~     of, but have no impact on the production of bilirubin.~      Stannsoporfin is a heme oxygenase inhibitor that acts to reduce bilirubin production. It is~     being developed for the management of neonatal jaundice.~   "
128356|NCT01887314|"~     The purpose of the study is verify the capability of a standardized Ginger (Zingiber~     officinale) extract to manage nausea in cancer patients receiving highly emetogenic~     treatments and standard anti-emetogenic therapy.~   "
128357|NCT01887301|"~     A Phase I open-label study to evaluate the pharmacokinetics (what the body does to a drug),~     safety and tolerability of a single dose of Sativex (containing 10.8 mg tetrahydrocannabinol~     [THC] and 10 mg cannabidiol [CBD]) in healthy patients and those with hepatic (liver)~     function impairment.~   "
128358|NCT01887288|"~     To evaluate the Growth Modulation Index (GMI) of the combination of metronomic capecitabine~     with oral digoxin in metastatic breast cancer~   "
128359|NCT01887275|"~     The purpose of this study is to investigate the efficacy and safety of medical ozone in~     treatment of chronic hepatitis B patients.~   "
128360|NCT01887262|"~     Bioimpedance-guided fluid management in peritoneal dialysis patients may provide better~     protection of residual renal function over 1 year period, compared with management guided by~     clinical information alone - such as blood pressure, body weight, and physician's physical~     examination.~   "
128361|NCT01887249|"~     10-day sequential therapy was not sufficient to overcome tough situation for H. pylori~     eradication in Korea due to high antimicrobial resistance. The present investigators assumed~     that doubling duration of second phase of sequential therapy might have more potent~     bactericidal efficacy than previous 10-day sequential regimen. But 15-day regimen with~     initial 5-day PPI with amoxicillin followed by remaining 10-day PPI, clarithromycin with~     metronidazole was not ever tested before. Moreover, whether extending the sequential therapy~     to 15-day might be more effective than 10-day sequential therapy is unknown especially in~     Korea. From this background, the present investigators prepared clinical trials regarding~     modified sequential therapy which was extending the treatment duration to 15 days compared~     than previous 10-day sequential therapy regimen. In addition, pre-treatment antimicrobial~     susceptibility testing was performed to find the possibility to overcome antimicrobial~     resistance.~   "
128362|NCT01887236|"~     Individuals of advanced age undergo both physical and cognitive deterioration. The aim of~     this study is to explore the effect of two types of physical activity on stability~     parameters.~   "
128363|NCT01887223|"~     When the glaucoma filtering surgery failures (intraocular pressure rises again), the options~     is start to use the hypotensive eye drops again (medical treatment). However, in some cases~     (encapsulated blebs), there is a simple surgical revision that can revival the primary~     failure surgery. It calls transconjunctival needling revision. In this study, the~     investigators compare the efficacy of this revision versus medical treatment in 12-month~     follow up in eyes with encapsulated blebs.~   "
128364|NCT01887210|"~     This study will develop and test a novel, technology based intervention to improve treatment~     adherence among youth living with HIV who are taking antiretroviral medication. In the~     intervention youth will access an engaging and immersive app/game on their smartphone.Data~     about the opening of the smart pill bottle will be transferred from the bottle cap wirelessly~     and will trigger a text message about their adherence. While gaming, participants will gain~     information about their health, improve motivation for ARV and medical appointment adherence,~     and practice healthy behaviors. If the Intervention is found to be effective, it can be~     tested in a larger study and then disseminated to other youth on antiretroviral medications.~   "
128365|NCT01887197|"~     The investigators are developing a new nuclear medicine imaging technique for measuring~     liquid absorption in the airways that can be applied to screen new medications being~     developed to treat cystic fibrosis (CF). The investigators believe that the absorption of the~     small molecule radiopharmaceutical Indium 111 diethylene triamine pentaacetic acid (In-DTPA)~     will indicate changes in liquid absorption in the airways and demonstrate whether new CF~     medications will be effective. In this study the investigators will determine whether the~     imaging technique will demonstrate similar results when it is repeated on different days.~     They will also determine how their results change when subjects utilize several common CF~     medications.~   "
128392|NCT01886846|"~     We aimed to investigate if adiponectin facilitates diagnosis of ARF by analyzing adiponectin~     levels in acute and convalescent periods of the acute rheumatic fever and by comparing~     results with that of healthy control group; also by comparatively examining levels of~     adiponectin in ARF cases who had different clinical findings at presentation. In addition, we~     aimed to investigate its role in the pathogenesis of ARF by evaluating correlations with~     cytokines such as TNF-α, IL-6 and IL-8 and acute phase reactants.~   "
128418|NCT01886508|"~     The investigators designed this multicentre randomized study to investigate the clinical~     benefits of nerve-spring radical hysterectomy for cervical cancer. Patients with FIGO stage~     Ia2, Ib1, IIa1 and FIGO stage Ib2, IIa2 after neoadjuvant chemotherapy are randomized to~     either nerve-spring radical hysterectomy or radical hysterectomy. The primary endpoint are~     urodynamic outcome including maximum flow rate, residual volume, maximum vesical compliace,~     cystomctric capacity at first desire, and maximum cystomctric capacity. A total 240 patients~     (120 per treatment arm) are planned to accrue for this study within 7 years.~   "
128419|NCT01886495|"~     The investigators aimed to determine the effects of HP diet on adiponectin and inflammatory~     factors among overweight and obese children.~   "
128366|NCT01887184|"~     Upper gastrointestinal endoscopy, like many other diagnostic and therapeutic procedures, may~     be associated with discomfort. Although upper endoscopy is usually of shorter duration and~     better tolerated by patients, most trials investigating the influence of analgesia and~     sedation have been performed on patients undergoing this procedure. Some patients may~     tolerate colonoscopy without sedation, but various techniques are used to limit discomfort~     and pain. Selection and dosing of sedatives depends on the patient's emotional state, the~     intensity of pain during examination, foreseeable technical difficulties, the endoscopist's~     experience, the presence or absence of anesthesia personnel, and hospital-specific~     procedures.~      Conscious sedation is a popular technique for colonoscopy and upper gastrointestinal~     endoscopy. The combination of an opioid and a benzodiazepine is known to provide good~     analgesic and sedative conditions during endoscopy. This combination of opioid and~     benzodiazepine, however, also increases the risk of respiratory depression. Therefore,~     pharmacologic agents which may provide adequate sedation without respiratory depression are~     of great interest to clinicians.~      Dexmedetomidine is a highly selective α2-adrenoceptor agonist with sedative and analgesic~     effects. Compared with clonidine, it is more selective for the α 2 adrenoceptor and acts as a~     full agonist in most pharmacologic test models. Potentially desirable properties include~     decreased requirements for other anesthetics and analgesics, a diminished sympathetic~     response to stress and the potential for cardioprotective effects against myocardial~     ischemia. When compared with conventional sedatives such as opioids or benzodiazepines, its~     lack of respiration depression is a distinct advantage. Previous studies using~     dexmedetomidine for sedation has been promising with maintenance of respiratory function.~     Patients are readily arousable. With intravenous slow bolus administration, there is a~     minimal increase in blood pressure initially, followed by a slight decrease in blood~     pressure. Lower dose ranges, avoidance of rapid bolus injection, and a slow rate of~     administration tend to decrease these circulatory side effects. Many clinical studies have~     shown that it can be well and safely used intravenously, intramuscularly and transdermally.~     Although not an officially technique, there are also reports of intranasal administration~     resulting in fairly predictable onset in both adults and children.~   "
128367|NCT01887171|"~     The purpose of this study is to determine whether the Tacrolimus added to~     histidine-tryptophan-ketoglutarate (HTK) solution given through intraportal and intraarterial~     infusion during back-table procedure is capable of reducing the degree of early allograft~     liver dysfunction, as assessed by postoperative levels of aspartate aminotransferase (AST),~     alanine aminotransferase (ALT), during first 7 postoperative days and by serum and~     histochemical markers of liver injury and inflammation.~   "
128368|NCT01887158|"~     Studies that have investigated different bowel preparations in patients with history of~     colorectal surgery are surprisingly lacking.Therefore, which is the best colon preparation in~     this subgroup of patients is still unknown. Polyethylene glycol (PEG)-based solutions are the~     most popular and safest bowel preparation regimens, however the 4-Liter volume is often~     poorly tolerated. More recently, it has been shown that the use of a low volume preparation~     (2-Liter PEG solution with the adjunct of a laxative, bisacodyl) achieves comparable bowel~     cleanliness rates to 4-Liter PEG in general population.The primary aim will be to compare the~     efficacy of 2-L mixed preparation (bisacodyl plus PEG) to 4-L PEG preparation.~   "
128369|NCT01887145|"~     No randomized trials have compared long-term outcomes following endoscopic and open carpal~     tunnel release in patients with carpal tunnel syndrome (CTS). The investigators conducted a~     single-center randomized controlled trial between January 1998 and December 2002, including~     128 patients (25 to 60 years) with clinically diagnosed and electrophysiologically confirmed~     idiopathic CTS. The outcome measures included the validated CTS symptom severity and~     functional status scales completed at baseline and 1 year postoperatively. The trial showed~     that the 1-year outcomes of open and endoscopic carpal tunnel release regarding symptoms and~     function were equivalent. This extended follow-up of the randomized trial will primarily~     measure the symptom outcomes at 10-15 years after surgery. A questionnaire will be sent by~     mail to the patients. The questionnaire will consist of the CTS symptom severity and~     functional status scales, the 6-item CTS symptoms scale (CTS-6), the 11-item disabilities of~     the arm, shoulder and hand (QuickDASH), the 2-item palmar pain scale, and a visual analog~     scale about treatment satisfaction. The patients will also be asked about whether they had~     undergone further surgery for CTS in the same or contralateral hand after their operation in~     the randomized trial. The completed questionnaires will be scanned into a database. The~     scores for the different scales will be calculated. Analysis will include comparison between~     the open and endoscopic groups as well as within-group changes of scores from 1 year to 10-15~     years.~   "
128370|NCT01887132|"~     Background:~      - Some children with autism spectrum disorders (ASD) do not have normal sleep cycles. Some of~     these children spend very little time in the rapid eye movement (REM) stage of sleep. Some~     studies suggest that less time in REM sleep can be associated with learning and behavior~     problems. Donepezil is a medication used to treat Alzheimer s disease. Donepezil can increase~     REM sleep in some adults with different disorders. A small study showed that Donepezil can~     also increase REM sleep in children with ASD. Researchers now want to see if Donepezil can~     improve communication skills and social interaction in children with ASD. They also want to~     see if any change in symptoms seems to come from changes in REM sleep.~      Objectives:~      - To see if a medication, Donepezil, can improve the way communication skills and social~     interaction develop in young children with autism spectrum disorders.~      Eligibility:~      - Children 22 to 44 months of age with ASD.~      Design:~        -  Participants will be screened with a blood test, heart tests, and a sleep study. During~          the sleep study, children will sleep in a darkened room for 2 nights with electrodes on~          their body and a tube under their nose. Parents can sleep in the room with their child.~          A technician will monitor the room all night.~        -  Participants will take the study medication once a day.~        -  Treatment will be monitored at visits every 3 months. At each visit the participant will~          take blood tests, heart tests, or behavior tests. Participants will have 2 more sleep~          studies.~        -  Participation will end after 18 months.~   "
128402|NCT01886716|"~     The purpose of this research is to test a computerized intervention for people with~     co-occurring social anxiety and alcohol dependence. The intervention seeks to reduce symptoms~     by shifting attention away from alcohol-relevant and/or socially threatening cues. The~     investigators expect that participants receiving alcohol or anxiety training will experience~     reductions in those specific symptoms compared to participants in a control condition. The~     investigators also expect that participants receiving combined alcohol and anxiety training~     will show the largest reductions in alcohol and anxiety symptoms, relative to participants in~     any other condition.~   "
128403|NCT01886703|"~     This pilot study will assess whether a supported pedometer-based walking program is helpful~     in maintaining physical activity for breast and head-and-neck cancer patients who are~     undergoing radiation therapy. Follow-up monitoring sessions will be scheduled to help provide~     support for physical activity during radiation therapy. We will also examine the relationship~     of physical activity and quality of life outcomes to help inform future research.~   "
128420|NCT01886482|"~     The investigators aimed to determine the effects of HP diet on CVD risk factors among~     overweight and obese children.~   "
128371|NCT01887119|"~     The prevalence of obesity and obesity-related complications is currently taking epidemic~     proportions. These complications increase the risk of type 2 diabetes and cardiovascular~     disease, which are important causes of morbidity and mortality worldwide.~      It is important to gain insight in the mechanisms underlying obesity-related complications,~     because this may lead to the development of directed therapeutic strategies.~      Currently, there is significant evidence that the cause of both insulin resistance and~     hypertension must be sought at the level of the microcirculation.~      Over activity of the renin-angiotensin-aldosterone system is a potential cause of~     microvascular dysfunction. Angiotensin II was indeed found to be implicated in the~     pathogenesis of obesity-associated hypertension and insulin resistance, possibly through~     interference with the vascular effects of insulin.~      Increased aldosterone levels have also been associated with resistant hypertension and~     insulin resistance, which is illustrated in patients with primary aldosteronism. Furthermore,~     aldosterone is known to exert several detrimental effects on the vasculature, some of which~     are offset by mineralocorticoid receptor antagonists.~      In obese individuals, plasma aldosterone concentrations are increased as well. We hypothesize~     that increased aldosterone levels in adipose persons induce microvascular dysfunction, which~     contributes to the development of insulin resistance and hypertension, and mineralocorticoid~     receptor antagonism results in improved insulin sensitivity and decreased blood pressure by~     counteracting the adverse effects of aldosterone on the microvasculature.~   "
128372|NCT01887106|"~     The purpose of this First-in-Human study is to evaluate the safety and tolerability after~     single ascending oral doses of GLPG1205 given to healthy male subjects, compared to placebo.~     Also, the safety and tolerability of multiple ascending oral doses of GLPG1205 given to~     healthy male subjects daily for 14 days compared to placebo, will be evaluated.~      Furthermore, during the course of the study after single and multiple oral dose~     administrations, the amount of GLPG1205 present in the blood and urine (pharmacokinetics) as~     well as the receptor occupancy by GLPG1205 in blood samples (pharmacodynamics) will be~     characterized compared to placebo.~      Also, the potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1205~     will be explored.~   "
128373|NCT01887093|"~     It has been well known that moderate and regular levels of physical activity has a favorable~     effect on many of the established risk factors related to coronary artery disease (CAD).~     Given that exercise in the morning has a greater potential for inducing sudden cardiac death~     and myocardial ischemia, it may be sensible for patients with CAD not to take exercise at~     this time. Our previous study indicated that the protective effect of exercise in the evening~     was greater than morning. However, which times of day to exercise could achieve the greatest~     improvements in lipids and inflammatory markers remains unclear. The purpose of the present~     study was to investigate the responses of lipid profiles and inflammatory markers to walking~     at different times of day in sedentary patients with CAD.~   "
128374|NCT01887080|"~     The aim of this study was to investigate the effects of electric stimulation~     (electrolipolysis) in a home-based cardiovascular rehabilitation program in patients with~     acute myocardial infarction~   "
128375|NCT01887067|"~     To demonstrate the efficacy of renal denervation therapy in treating resistant hypertension~     and its effect on glucose metabolism in patients with type 2 diabetes mellitus~   "
128376|NCT01887054|"~     This study is designed to evaluate whether a specific visuospatial training task will change~     gait performance of Parkinson's disease (PD) patients in doorways, specifically freezing of~     gait.~   "
128377|NCT01887041|"~     To compare the quality of life (QoL) in patients receiving a bilioenteric anastomosis vs.~     endoscopical stenting for palliation of biliary obstruction due to locally unresectable or~     metastatic pancreatic cancer. In the past, endoscopy seems to have been favoured based on~     older studies, but with new chemotherapeutic regimens available, the likelihood to experience~     stent complications has increased. Therefore, the issue as to which palliation should be~     favoured has to be reconsidered.~   "
128378|NCT01887028|"~     Use lay language.~      The primary purpose is to compare the impacts of intraperitoneal pressure (8mmHg versus 12~     mmHg) and CO2 gas (cool, dry CO2 gas versus warmed, humidified CO2 gas) on gene expression in~     peritoneal tissues during laparoscopic surgery. We hypothesize that combined use of a low~     Intraperitoneal pressure (8mmHg) and warmed, humidified CO2 gas during CO2 pneumoperitoneum~     may be better in minimizing adverse effects on surgical peritoneal environment and improving~     clinical outcomes compared to the standard intraperitoneal pressure (12mmHg) and standard~     cool, dry CO2 gas.~   "
128379|NCT01887015|"~     To evaluate whether early application of nasal high flow oxygen therapy after extubation can~     reduce the incidence of postoperative hypoxemia (defined as a PaO2/FiO2 ratio <300) after~     abdominal surgery in patients with intermediate to high risk of postoperative pulmonary~     complications.~   "
128380|NCT01887002|"~     The objective is to evaluate whether ONO-2952 modulates visceral pain perception produced by~     rectal distention in female patients with IBS-D~   "
128381|NCT01886989|"~     This study aims to investigate the postprandial effects of cocoa supplementation in glucose~     and lipids, and surrogate markers of atherosclerosis in patients with type 2 diabetes. The~     investigators aim to test the hypothesis that cocoa will lower high-fat mixed meal~     breakfast-induced postprandial rise of glucose, lipids and markers of atherosclerosis in~     patients with diabetes. Randomized cross-over controlled trial, in which participants will be~     assigned to the placebo or cocoa group with breakfast meal. Patients with type 2~     diabetes(n=25) will qualify for the study. The participants will be asked to consume 2 cups~     cocoa or placebo beverage on 2 separate postprandial study days. Both groups will receive~     high-fat mixed meal breakfast on each day. Blood draws and blood pressure (including HDI)~     measurements will be conducted at fasting, 30 min, 1,2, 4 & 6 hours postprandial each day for~     2 days.~   "
128382|NCT01886976|"~     RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory~     into patient autologous or donor-derived T cells may make the body build immune response to~     kill cancer cells.~      PURPOSE: This clinical trial is to study genetically engineered lymphocyte therapy in~     treating patients with CD138 positive multiple myeloma that is relapsed (after stem cell~     transplantation or intensive chemotherapy) or refractory to further chemotherapy.~   "
128404|NCT01886690|"~     This study will compare the safety and efficacy of a new eye drop formulation with REFRESH~     PLUS® in participants following LASIK surgery.~   "
128383|NCT01886963|"~     The purpose of this project is to assess the efficacy of the Spy Elite System (LifeCell~     Corporation, Branchburg, NJ, USA) in planning tissue advancement flaps and reducing wound~     complications after complex ventral hernia repairs. Complex ventral hernia repairs are~     associated with a high rate of wound complications. To a large degree these complications are~     caused by creating tissue advancement flaps to close the abdomen, which can compromise the~     blood supply to the skin and subcutaneous tissues. The current standard of care for~     assessment of blood perfusion to the flaps is a surgeon's clinical judgment. It is, however,~     often inaccurate. The Spy Elite System was developed to address this problem. The Spy Elite~     System is a device that enables surgeons to visualize and evaluate tissue perfusion in real~     time. It can help the surgeon to identify optimal flap design and reduce the risk of~     postoperative wound complications related to tissue ischemia. The primary goal of this study~     is to evaluate the efficacy of Spy Elite System to aid a surgeon in creating tissue flaps~     with adequate blood supply through a prospective, randomized clinical trial. The Spy Elite~     System has been used successfully for assessing the viability of mastectomy flaps in breast~     surgery and has been shown to be extremely sensitive in predicting mastectomy flap necrosis.~     However, no clinical trial has been conducted in order to evaluate the efficacy of the Spy~     Elite System for assessing the viability of abdominal subcutaneous flaps in complex ventral~     hernia repairs.~   "
128384|NCT01886950|"~     A study of the natural history of bone and mineral disease (BMD) in patients with end-stage~     renal disease before and after kidney transplantation~   "
128385|NCT01886937|"~     The goal of this study is to determine whether one week of phentermine compared to placebo~     administration results in changes in food intake during a laboratory meal.~   "
128386|NCT01886924|"~     The long-term goal of this program of research is to disseminate an effective, brief~     computer-based intervention that can be readily integrated into HIV treatment settings to~     motivate tobacco quitline use among smokers living with HIV. The overall objective of this~     application is to develop this computer intervention, modify it based on initial piloting and~     feedback, and obtain preliminary data supporting the efficacy of the intervention. This will~     be accomplished by pursuing three specific aims: 1) to develop and conduct preliminary pilot~     testing (n=16) of a brief, computer-based intervention intended to motivate tobacco quitline~     use among cigarette smokers living with HIV (Computer Intervention to Motivate Engagement in~     Tobacco Quitline treatment; CI-METQ) and to develop and pilot (n=4) a computer-based, time~     matched nutrition education for PLWH control intervention (NC) equated for the offer of a~     tobacco quitline referral and 8 weeks of free nicotine patch for those who engage in quitline~     treatment, 2) to conduct a preliminary smoking cessation, randomized controlled trial (RCT)~     with 100 people living with HIV (PLWH) who smoke cigarettes, comparing CI-METQ vs. NC, with~     predictions that CI-METQ relative to NC will result in increased readiness, higher rates of~     tobacco treatment engagement, more quit smoking attempts and higher rates of 7-day point~     prevalence abstinence rates at 1-, 3- and 6-month follow-ups. Health-related quality of life~     over this period will also be examined, and 3) to examine CI-METQ's effects on key mechanisms~     during the computer session and their associations with tobacco treatment engagement and~     smoking outcomes at 1- and 3-month follow-ups.~   "
128387|NCT01886911|"~     This project is focused on the neural and behavioral correlates of two different videos games~     that will be used as training tools. The two video games, developed by the Games Learning~     Society research group at the University of Wisconsin-Madison (UW) and the Wisconsin~     Institute for Discovery, are tailored to train mindfulness, particularly the regulation of~     attention; and prosocial behavior, especially sensitivity to others, in adolescents. This~     study will evaluate the hypothesis that systematic playing of mindfulness and prosocial games~     will change brain function in specific attentional, social and emotional circuits in~     potentially beneficial ways, and will impact performance on cognitive tasks of attention, and~     on measures of social cue perception and the propensity to share and behave altruistically.~     The investigators will employ behavioral and functional MRI-based neuroimaging measures to~     evaluate the investigators hypothesis.~   "
128388|NCT01886898|"~     The primary objective of the trial is to assess the growth of the infants enrolled into the~     study. Other parameters to be measured include microbiota balance and certain blood~     biochemical values. In addition the infants' digestive tolerance of the formulae and~     frequency of morbidity will be investigated.~   "
128389|NCT01886885|"~     The primary objective for this pilot study is to determine if the Mindfulness-Based Chronic~     Pain Management (MBCPM) intervention would decrease pain and pain catastrophizing and~     increase pain acceptance in participants with chronic pain. The secondary objective is to~     explore if MBCPM will reduce depression and increase quality of life and mindfulness in the~     same group of participants. The additional aim of the pilot study is to evaluate the~     feasibility of conducting the MBCPM intervention in participants with chronic pain. We~     hypothesize that participants with chronic pain will show relatively good compliance with~     completing the MBCPM protocol and will show increased satisfaction associated with~     improvement in pain-related and other psychosocial indicators of functioning.~   "
128390|NCT01886872|"~     This randomized phase III trial studies rituximab with bendamustine hydrochloride or~     ibrutinib to see how well they work compared to ibrutinib alone in treating older patients~     with previously untreated chronic lymphocytic leukemia. Monoclonal antibodies, such as~     rituximab, may block cancer growth in different ways by targeting certain cells. Drugs used~     in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the~     growth of cancer cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Ibrutinib may stop the growth of cancer cells by blocking some~     of the enzymes needed for cell growth. It is not yet known whether rituximab with~     bendamustine hydrochloride may work better than rituximab and ibrutinib or ibrutinib alone in~     treating chronic lymphocytic leukemia.~   "
128391|NCT01886859|"~     This phase I trial studies the side effects and best dose of lenalidomide when given together~     with ibrutinib in treating patients with chronic lymphocytic leukemia or small lymphocytic~     lymphoma that has returned after a period of improvement or does not respond to treatment.~     Biological therapies, such as lenalidomide, may stimulate the immune system in different ways~     and stop cancer cells from growing. Ibrutinib may stop the growth of cancer cells by blocking~     some of the enzymes needed for cell growth. Giving lenalidomide together with ibrutinib may~     work better in treating chronic lymphocytic leukemia or small lymphocytic lymphoma.~   "
128393|NCT01886833|"~     Zambia recently introduced routine infant immunization against rotavirus - the most important~     cause of severe gastroenteritis and diarrhoea mortality in children. Although vaccines like~     Rotarix are a cost effective tool against infectious diseases, live oral vaccines can be less~     immunogenic and efficacious in developing world settings as compared with industrialized~     countries. Reasons behind this phenomenon are not well understood, but may relate to~     continued maternal antigen exposure and high level maternal immunity that is passed to the~     foetus/newborn transplacentally and/or through breast milk.~      Therefore, three arising hypotheses include: (i) high-level rotavirus-specific maternal~     immunity (in the form of anti-rotavirus breast-milk IgA and transplacental serum IgG) is a~     major contributor to failed seroconversion following infant vaccination. (ii) Malnutrition~     negatively impacts infant immunity and increases the risk of post-vaccination rotavirus~     gastroenteritis. (iii) Introduction of rotavirus vaccine will alter the molecular~     epidemiology of circulating rotavirus strains detected in vaccinated children presenting with~     severe diarrhea.~      To address these hypotheses, the proposed study will recruit a prospective cohort of 420~     mother-infant pairs. These will be enrolled at the time of vaccination and followed for up to~     four years. Baseline immunological status will be ascertained and seroconversion rates~     determined a month after full immunization. Incident rotavirus gastroenteritis will be~     monitored in the vaccinated infants whenever episodes of diarrhoea occur; through this~     surveillance, the sero-strains of rotaviruses causing disease will be tracked over the four~     year period. Contributions of HIV infection both in mothers and infants, vitamin A and zinc~     deficiency, weight for age Z-scores as well as mid upper arm circumference will also be~     assessed. Knowledge gained from this study will inform future interventional trials on~     strategies to improve rotavirus vaccine effectiveness in the developing world.~   "
128394|NCT01886820|"~     To Determine the the Efficacy and Safety of [18F]NAV4694 PET for Detection of Cerebral~     β-Amyloid When Compared With Postmortem Histopathology~   "
128395|NCT01886807|"~     Patient demographics (age, height and weight) will be collected for 546 consecutive patients~     presenting for dental restoration under general anesthesia. The baseline saturation will be~     recorded. The induction of anesthesia will be standardized for all patients. All patients~     will undergo an inhalational induction administered by face mask. After inserting an~     intravenous (IV) line, rocuronium will be administered. Intravenous propofol and fentanyl~     could be added at the discretion of the anesthesiologist. The patients will be mask~     ventilated then be with a mixture of Air/Oxygen (O2) to achieve an FiO2 of 0.3 for 3 minutes~     after the administration of rocuronium.~      Patients will be randomly assigned to one of three groups for the purpose of airway~     management: 1) direct laryngoscopy for nasotracheal intubation without oxygen insufflation~     (DL group); 2) direct laryngoscopy for nasotracheal intubation with oxygen insufflation (DLO2~     Group); and 3) nasotracheal intubation using the Truview PCD video laryngoscope (VL Group).~     Computer-generated treatment allocations (using the PLAN procedure in SAS statistical~     software, using random-sized blocks) will be maintained in sequentially numbered sealed~     envelopes that will be opened after consent is obtained. The laryngoscopy and intubations~     will be performed by the study investigators who are faculty anesthesiologists or by the~     mid-level or resident or fellow working with them.~      The study will be stopped when:~        -  the patient will be intubated and a CO2 trace is obtained on the capnography or~        -  if the patient desaturates to 90%~        -  or if the patient shows signs of cardiac instability (ectopic beats, arrhythmia or~          hypotension)~      Randomized groups will be compared for balance on potentially confounding baseline variables~     using descriptive statistics. Primary outcome: In the primary hypothesis, desaturation will~     be characterized using both time to 1% saturation drop from the baseline and the rate (slope)~     of desaturation after an initial 1% drop. We will consider a given intubation technique (DLO2~     or VL) better than DL on controlling saturation if found noninferior (i.e., not worse) on~     both outcomes and superior on at least one of the outcomes. Thus our primary hypothesis will~     be assessed in a joint hypothesis testing framework described by Mascha and Turan. We~     a-priori define the non-inferiority delta for the outcome time to 1% drop as 5 seconds (or~     1.05 if using hazard ratio) and the slope delta as 0.05 percent per second.~   "
128396|NCT01886794|"~     Our primary aim in the current study is to determine important tissue differences, including~     muscle and connective tissue changes, between postmenopausal women and reproductive age women~     with pelvic floor dysfunction to help develop targeted and noninvasive treatments.~   "
128397|NCT01886781|"~     In patients with IBS, will supplementation with a probiotic demonstrate symptomatic efficacy~     and will the probiotic influence gut microflora and thus improve clinical outcomes, as~     compared to no intervention.~   "
128398|NCT01886768|"~     Unsedated ultrathin transnasal esophago-gastro-duodenoscopy (UT-EGD), in comparison with~     conventional peroral EGD (P-EGD) has been shown to be more tolerable, safer, cost-effective~     and time-efficient. The investigators and in other studies have showed that nasal pledgetting~     (or commonly termed nasal packing) is better than nasal spray in terms of patient tolerance~     and visual capacity. Although pledgetting method to a selected meatus can achieve better~     decongestion effect, epistaxis and nasal pain in some patients are still frustrating to~     endoscopists.~      The investigator has proposed a novel meatus scoring scale to evaluate nasal insertability by~     anterior rhinoscopy using a transnasal endoscope. The investigator also suggest~     endoscopic-guided gauze pledgetting can provide precise nasal anesthesia, thereby reducing~     trauma/bleeding in the nasal cavity and increasing patient tolerance during transnasal~     endoscopy. Endoscopic guidance to deliver a gauze strip can confirm delivering it to at least~     the posterior end of a turbinate. We hypothesize that by using endoscopic-guided method,~     gauze pledgetting to both the inferior nasal meatus (INM) and middle nasal meatus (MNM)~     simultaneously is more tolerable than only gauze pledgetting to a single meatus.~   "
128399|NCT01886755|"~     An ORS with L. reuteri DSM 17938 and zinc is expected to reduce duration and severity of~     symptoms in infants and young children with acute gastroenteritis.~   "
128400|NCT01886742|"~     The population continues to increase in weight. Currently there are no guidelines in the~     dosing of cefazolin for the obese population. Standard dosing of cefazolin 2 grams for~     patients <120 kg and 3 grams for patients >120 kg is used as the dose for surgical~     prophylaxis. This makes no provisions for weight based dosing. There has been some recent~     data which states this might not be enough for the obese patients. The primary objective of~     this study is to determine if weight based dosing (30 mg/kg) of cefazolin as surgical~     prophylaxis for patients undergoing elective gastric bypass/laparoscopic Roux-en-y gastric~     bypass provides appropriate serum concentrations for a larger percentage of time than the~     current method of giving the standard 2 or 3 gram doses of cefazolin peri-operatively. The~     concentration of cefazolin in tissue will also be measured to help assess this question.~   "
128401|NCT01886729|"~     The treatment for patients with acute tinnitus consists of Methylprednisolone and hyperbaric~     oxygen therapy. For this study transcranial direct current stimulation (tDCS) was added to~     the protocol. The purpose is to determine the effect of the time shift of tDCS. Two~     conditions will be compared: tDCS simultaneously with the hyperbaric oxygen therapy or tDCS 3~     weeks after the start of the tinnitus.~      An audiological testing will be performed at the day of admission, after 3 weeks, 6 weeks and~     12 weeks.~   "
128405|NCT01886677|"~     RATIONALE: Obesity and overweight are associated with the risk of aggressive disease, and~     energy balance may play a major role in prostate cancer progression.~      PURPOSE: Randomized phase II trial to study the effectiveness of weight loss, via a healthy~     energy-restricted diet and exercise, in slowing or preventing disease progression in patients~     who have newly diagnosed prostate cancer.~   "
128408|NCT01886638|"~     HIV positive patients have a two fold increased risk of developing cardiovascular disease~     (such as heart attacks and strokes). Cardiovascular disease appears to be due in part to both~     HIV and the side effects from anti-HIV medications.~      Abacavir (an important component of current HIV treatment regimens) is one medication shown~     to be associated with an increase the risk of heart attacks in some studies. The mechanism by~     which abacavir does this is unknown.~      We hypothesise that abacavir is leading to heart disease by interacting with platelets, which~     then form blood clots within the arteries supplying the heart, the subsequent blockage of the~     artery causing a heart attack.~      This study aims to determine if abacavir increases the activity (or stickiness) of~     platelets, and thus provide evidence as to how it may be promoting heart attacks.~      It will consist of 23 HIV positive men who currently have well controlled HIV. Participants~     will take abacavir for 15 days in addition to their usual anti-HIV medications. A blood~     sample to assess platelet activity will be taken at baseline, following the 15 days of~     therapy (i.e. at the time of maximal abacavir effect) and again after a 28 day washout period~     (to determine if any effects are reversible).~   "
128409|NCT01886625|"~     Background of the study: CRPS type-1 is a pain syndrome that usually develops after an~     initiating noxious event (e.g. fracture) in an extremity. Although treatment options life~     dimethyl-sulphoxide (DMSO), N-acetylcysteine (NAC) and intensive physical therapy exist, the~     treatment effect is often unsatisfactory, even leading to amputation of the extremity.~     Surgical treatment of chronic pain disorders by dividing the sympathetic chain is an~     established treatment. Its more invasive nature has prevented widespread application. After~     introduction of minimal invasive techniques in recent years, the UMCG has now devised a truly~     minimal invasive, yet safe and effective thoracoscopic technique, that requires only a single~     1 cm long incision in the anterior axillary line. This technique is developed as treatment~     for primary focal axillary and palmar hyperhidrosis, and is performed in over 50 patients~     producing very satisfying results. This fact has led to the hypothesis that this same~     surgical technique can offer this group of chronic pain patients a safe, effective treatment~     modality.~      Objective of the study: The effect of the intervention on pain an regain of function in de~     affected extremity. This will be quantified in multiple questionnaires at baseline and three~     follow-up points, and by clinical evaluation of the hand function at baseline and two~     follow-up points.~      Study design: Single center prospective feasibility study~   "
128410|NCT01886612|"~     Deep Vein Thrombosis (DVT) is a life threatening condition and a serious concern among~     hospitalized patients, with death occurring in approximately 6% of cases. It involves the~     formation of a clot where stagnant blood flow occurs, predominantly in the deep veins of the~     legs. Three mechanisms underlie DVT, venous stasis (slowing or stopping of the blood),~     hypercoagulability (increased clotting) and damage to blood vessel endothelium (damage to~     blood vessel wall), collectively known as Virchow's triad.~      Intermittent pneumatic compression (IPC) and neuromuscular electrical stimulation (NMES) have~     been shown to improve lower limb blood flow. However, few studies have directly compared the~     two methods and those that have, have used dated NMES techniques.~      The objective of this study is to compare the two methods in terms of blood flow.~   "
128411|NCT01886599|"~     The purpose of the study is to determine how Asunaprevir is handled by the body of subjects~     with kidney disease compared with subjects with normal kidney function~   "
128412|NCT01886586|"~     This study will adapt Problem Solving Therapy (PST) for individuals with mild cognitive~     impairment (MCI) as an intervention for preventing major depression (DEP). PST will be~     modified so as to be provided to both MCI probands as well as their support person. The~     primary aim is to examine the effectiveness of PST in individuals with MCI and the support~     person, at preventing DEP over 12 mos. in MCI probands. We also will examine the effect of~     exercise on preventing depression.~   "
128413|NCT01886573|"~     This pilot clinical trials studies azacitidine and entinostat in treating patients with newly~     diagnosed stage IA-IIIIA non-small cell lung undergoing surgery. Drugs used in chemotherapy,~     such as azacitidine, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Entinostat may stop the growth of cancer~     tumor cells by blocking some of the enzymes needed for cell growth. Giving azacitidine with~     entinostat may be an effective treatment for non-small cell lung cancer.~   "
128414|NCT01886560|"~     To evaluate the safety and efficacy of oral low dose doxycycline in the treatment of corneal~     burn.~   "
128415|NCT01886547|"~     We aim to determine the effectiveness of 2013 Mag paDRE ka programme in increasing general~     public awareness on prostate health and promoting prostate health assessment among Filipino~     males aged 40 or older.~   "
128416|NCT01886534|"~     Close to ninety percent of older heart failure (HF) patients have some cognitive deficits at~     hospital discharge which may impact their ability to make effective decisions about their~     healthcare. However, informal care partners (CPs) may assist in managing HF when provided~     with appropriate education and support. The goal of this randomized clinical trial (RCT) is~     to evaluate an intervention which will provide 1) additional teaching on management of HF to~     the patient and CP following hospital discharge, 2) improved communication with the family~     physician, 3) a HF decision support tool for oral diuretic management, and 4) a digital~     talking scale. The investigators believe this intervention will improve outcomes and be cost~     saving.~      The investigators hypothesize that enhanced education and support for the CPs to assist older~     HF patients following hospital discharge, combined with improved communication with family~     physicians, contact with a HF nurse, and simple decision support tools, will lead to earlier~     recognition of clinical deterioration, and improved patient outcomes. Innovative and~     cost-effective approaches to manage HF patients following hospital discharge are urgently~     needed in Canada.~   "
128417|NCT01886521|"~     Recently, a clinical trial showed that the use of lumbar drains compared to ventricular drain~     in patients suffering from subarachnoid hemorrhage resulted in less delayed ischemic~     neurological deficits but failed to show a clinical benefit after 6 months. The underlying~     assumption was, that the cerebrospinal fluid (CSF) obtained from lumbar drains has a higher~     concentration of blood than CSF from lumbar drains. The investigators decided to test this~     assumption. In this study, the investigators will randomize patients to either placement of a~     ventricular or a lumbar drain and analyze the CSF drainage on a daily basis.~   "
128422|NCT01886456|"~     To investigate the effect of patterned laser trabeculoplasty (PLT) compared to selective~     laser trabeculoplasty (SLT) on intraocular pressure (IOP) in treatment naiv patients~     suffering from open-angle glaucoma or ocular hypertension.~      Values for IOP will be measured at baseline, 1 day and 1 month post-interventional as well as~     2, 3, 6, 9, 12, 18 and 24 months after treatment.~        -  Trial with medical device~   "
128423|NCT01886443|"~     The purpose of this study is to establish the safety of the combined drug approach~     (anti-thrombin III, infliximab, apotransferrin, human recombinant erythropoietin beta,~     C1-inhibitor, glutathione, alfa-tocopherol, melatonin and epoprostenol)aimed to reduce~     ischemia-reperfusion injury during liver transplantation in eligible recipients.~   "
128424|NCT01886430|"~     The purpose of this study is to verify the effects of low frequency functional electrical~     stimulation in heart failure patients hospitalized for treatment of the syndrome.~   "
128425|NCT01886417|"~     Auditory verbal hallucinations (AVHs) are speech perceptions in the absence of a relevant~     external stimulation. Some accounts of AVHs claim that a deficit in inner speech monitoring~     would cause the verbal thoughts of the patient to be perceived as external voices resulting~     in AVHs.~      In order to examine whether AVHs correspond to self-generated inner speech, the present study~     aims at collecting speech muscle activity during covert AVHs (without articulation), overt~     speech and rest. Surface electromyography (sEMG) is used on schizophrenia patients and~     control subjects to detect any speech muscle activity during AVH.~   "
128426|NCT01886404|"~     The primary purpose of this study is to investigate the steady-state pharmacokinetics of~     efavirenz in older HIV-infected patients as compared to historical controls; to investigate~     the relationship of drug exposure to neuropsychiatric side effects and neuropsychological~     performance; and to explore the role of host polymorphisms in drug metabolism in the older~     patient.~   "
128427|NCT01886391|"~     The purpose of this study is to provide information on how the practicing of deep~     breathing(DBR - diaphragmatic breathing re-training)may improve the health outcomes and~     likelihood of heart failure patients to engage in health-promoting activities by successfully~     controlling their shortness of breath (dyspnea).~   "
128428|NCT01886378|"~     UX007-CL201 is an open-label Phase 2 study to assess the safety and clinical effects of UX007~     in subjects with LC-FAOD. Following a 4 week run in period on current therapy, subjects will~     cross over to daily UX007 treatment for an initial 24 week treatment period, followed by an~     additional 54 week extension period. Approximately 30 subjects at least 6 months of age~     inclusive with severe LC-FAOD, specifically VLCAD, LCHAD, CPT 2, or TFP disorders, will be~     enrolled and treated with UX007.~   "
128429|NCT01886365|"~     The debate about tight glycemic control (TGC) in the operating room and on the intensive care~     unit is ongoing, especially in cardio-surgical patients treated with blood cardioplegia, due~     to high blood glucose levels during operations and subsequent high rates of sternal wound~     infections. We showed in a feasibility study that early computer based insulin therapy~     starting in the operating room is a safe therapy that allows to better warrant normoglycemia~     in patients undergoing major cardiac surgery with the use of blood cardioplegia.~   "
128430|NCT01886352|"~     In this study, we will compare 3 treatments. The first group of patients will receive the~     standard treatment (paracetamol, diclofenac and an opioid if necessary) with infiltration of~     the portal sites with the local anesthetic ( 0.5% levobupivacaine) . The second group of~     patients will receive the standard of care, with infiltration of the portal sites with the~     local anesthetic ( 0.5% levobupivacaine) and additional injection of the local anesthetic (~     0.5% levobupivacaine, non -diluted) in the peritoneal cavity via a trocar both at the~     beginning and the end of the surgery . The third group of patients will receive the standard~     of care, with infiltration of the portal sites with the local anesthetic ( 0.5%~     levobupivacaine) and additional intraperitoneal atomization of the local anesthetic. We will~     use non-diluted 0.5% levobupivacaine delivered directly onto the target sites both at the~     beginning and the end of surgery. The drug will be delivered using OptiSpray® surgical spray~     device, an inexpensive delivery system that will direct a fine mist of drug directly to the~     areas of the peritoneal cavity that are theoretically the cause of post-op pain (diaphragms,~     peritoneal abdominal surface, surgical dissection site).~      Our primary goal is to assess the efficacy of intraperitoneal atomization of levobupivacaine~     in reducing postoperative pain and of opioid requirements in patients undergoing~     gynecological laparoscopic procedures in one-day surgery.~   "
128431|NCT01886339|"~     SNIF test has been described as a method to explore the diaphragmatic function. But there are~     no defined the reference values of this test in healthy population. The investigators'~     hypothesis is that there is a variation on SNIF values in Mediterranean population depending~     on gender, age and anthropometric variables such as height and weight.~      The investigators will analyze 1000 SNIF test of healthy people. The investigators will~     divide in 5 groups of age (20-30, 30-40, 40-50, 50-60, 60-70) and in each group the~     investigators will study 100 men and 100 women.~      All the subjects will perform a forced spirometry, maximal inspiratory pressure (MIP) and~     SNIF. If spirometry and MIP are correct the investigators will consider that person has a~     correct diaphragmatic function and strength. Then the investigators will measure the SNIF~     test. With all of these SNIF values the investigators will try to achieve the reference~     values of this test in the different groups of age in Mediterranean population. And the~     investigators will compare SNIF with MIP.~      Cross multicentric study. Hospitals involved: Hospital de Bellvitge, Hospital del Mar,~     Hospital Parc Taulí, Hospital de la Santa Creu i Sant Pau (coordinator center) and Hospital~     de la Vall d'Hebrón.~   "
128444|NCT01886170|"~     In this two-phase mixed methods study, the investigators will first use patient feedback from~     semi-structured interviews to explore the ways in which patients with diabetes understand~     their diabetes and assess their disease control. The investigators will also use these~     interviews to elicit patient feedback on promising alternative communication formats to the~     hemoglobin A1C (A1C). In the second phase of the study, the investigators will test new~     formats to communicate information regarding diabetes control to patients with poorly~     controlled diabetes. This phase will be a three arm RCT comparing the effect of A1C (standard~     medical information) versus two alternative formats on several participant outcomes,~     primarily glycemic control at 6 months post-intervention.~   "
128445|NCT01886157|"~     Hypothesis: Treatment of trigger finger by corticosteroid injection and splinting is superior~     to corticosteroid treatment alone.~   "
128432|NCT01886326|"~     Evidence is accumulating that peanut consumption confers health benefits, such as reduction~     of cardiovascular disease risk and possibly diabetes risk (Jenkins et al., 2008; Mattes et~     al., 2008). However, peanuts are a high fat, energy dense food and concerns about weight gain~     are widespread. Although research indicates that other characteristics of peanuts offset~     these properties, and that peanuts may be incorporated into diets without posing a threat to~     weight gain (Mattes et al., 2008), concern remains among policymakers, healthcare providers,~     and consumers. Furthermore, worry exists that eating salted peanuts may elevate blood~     pressure and that eating honey-roasted peanuts make elevate blood sugar. These fears create~     substantial obstacles to increased peanut consumption.~      Recommendations to increase peanut consumption may be made, but if they are not followed,~     there will be no impact on health. Additional knowledge is needed on: (1) the acceptability~     of peanuts consumed on a chronic basis, (2) the chronic intake of moderate levels of peanuts~     and body weight, and 3) the effects of peanuts on blood pressure and blood sugar. The~     proposed research will examine the acceptability of long-term inclusion of a single form~     versus varied forms of peanuts in the diet. It is expected that responses will be varied~     among individuals with different personality characteristics (e.g., prefer sweet versus~     savory foods, hedonic versus non-hedonic eaters). A better understanding of how different~     segments of the population choose to include peanuts in their diet and how to optimize~     long-term consumption should provide insights for better marketing and improved health.~     Furthermore, it is anticipated that eating salty peanuts will not raise blood pressure and~     that eating honey-roasted peanuts will not raise blood sugar. Documenting this will add~     credibility to the evidence that peanuts do not cause weight gain, as well as reinforce~     recommendations to increase peanut consumption for their health benefits.~   "
128433|NCT01886313|"~     Herpes zoster (commonly referred to as shingles) results from the reactivation of the~     varicella-zoster virus acquired during a primary infection, usually chickenpox. The virus~     lays dormant in the cells of the nerves until activated. Once activated, patients develop a~     characteristic red blistering rash which crusts and heals in 2 - 4 weeks. Postherpetic~     neuralgia (PHN), the term for pain persisting after the herpes zoster (HZ) eruption heals, is~     the most common and most feared complication of herpes zoster infection. The drug, Civamide~     is thought to desensitize the nerves and decrease the pain of PHN. This is the pharmacologic~     rationale for its use in the nose in postherpetic neuralgia of the trigeminal nerve, a nerve~     that is in the nose and transmits pain from the face. The objective of this study is to~     evaluate the safety and efficacy of intranasally administered Civamide (0.01%) for the~     treatment of moderate to severe daily pain associated with postherpetic neuralgia of the~     trigeminal nerve. Neuropathic pain must have persisted for ≥ 12 months.~   "
128434|NCT01886300|"~     This prospective, multicenter, observational study will evaluate the sustained response in~     patients with HBeAg positive chronic hepatitis B who are treated with Pegasys according to~     standard of care and in line with the current local labeling in routine clinical practice in~     Vietnam. Eligible patients will be followed for the duration of their treatment and for up to~     2 years thereafter.~   "
128435|NCT01886287|"~     The primary purpose of the study is to investigate the effects of high-dose octreotide on~     flushing, diarrhea, and quality of life in patients whose disease-related symptoms are~     inadequately controlled by the maximum approved dose of octreotide LAR.~   "
128436|NCT01886274|"~     Migraine has been described as one of the most common neurological diseases, with high social~     and economic impact. Despite the high prevalence, the pathophysiology of migraine is still~     unknown, several studies have been developed in order to advance the understanding of the~     pathophysiological mechanisms of the disease which are not yet entirely elucidated. The aim~     of this study is to observe the effects of transcranial direct current stimulation (tDCS),~     applied in the visual cortex, on neurophysiological and clinical measures (frequency,~     intensity, duration of attacks and severity of pain) in migraine patients.~   "
128437|NCT01886261|"~     Usability of the PALMS system, validity of the PALMS system and added value to an existing~     cohort study.~      Hypothesis: Addition of GPS device and use of PALMS system will allow researchers to better~     examine place-based interventions.~   "
128438|NCT01886248|"~     To evaluate efficacy and safety of AT-III treatment in patients with hepatic veno-occlusive~     diseases following hematopoietic stem cell transplantation.~   "
128439|NCT01886235|"~     This pilot clinical trial studies intravital microscopy for identifying tumor vessels in~     patients with stage IA-IV melanoma that is being removed by surgery. New imaging procedures,~     such as intravital microscopy, may determine the extent of melanoma.~   "
128440|NCT01886222|"~     This study is a prospective multi-centre randomized trial to compare the effect of long-term~     mild hypothermia versus routine normothermic intensive management in patients with severe~     traumatic brain injury.~      The primary hypothesis is that the induction of mild hypothermia (maintained at 34-35℃) for 5~     days will improve the outcome of patients at six months post injury compared with~     normothermia.~   "
128441|NCT01886209|"~     This study is designed to evaluate the effect of VX-509 on the pharmacokinetics (PK) of~     corticosteroids (prednisone or methylprednisolone) and the effect of corticosteroids on the~     PK of VX-509 and its metabolite. The study will also evaluate the safety and tolerability of~     VX-509 when coadministered with each of these corticosteroids.~   "
128442|NCT01886196|"~     Inflammation increases with aging and is implicated in the reduction of bone mass, muscle~     mass, and strength. Resistance training is safe and effective for increasing muscle mass and~     strength in older adults,however resistance training by itself cannot suppress inflammation.~     Ibuprofen is a non-steroidal anti-inflammatory drug that may provide benefits to muscle mass~     and strength when given after resistance training sessions in older adults; however, more~     evidence is required to confirm effects across the lifespan. The objectives are to determine~     the effect of 9 months of exercise training and ibuprofen supplementation, compared to~     placebo, in older women (≥65years)on the following dependent variables:~        -  bone density, geometry, and architecture~        -  muscle mass and strength~        -  balance~   "
128443|NCT01886183|"~     The objective of this work will be compare the effects of two balance training programs, one~     Nintendo Wii Fit-based and the other traditionally-based without the use of a gaming system,~     on the (1) motor function, (2) cognition, (3) balance and (4) gait in chronic stroke~     patients. It is a prospective, single blinded, randomized clinical trial performed at Center~     of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of~     São Paulo University. Forty patients will be randomly assigned in control and experimental~     group, 20 each one.~   "
128490|NCT01885572|"~     This multicentre, non-randomised, observational clinical device investigation will be~     performed to obtain postmarketing information on the TiLOOP® Bra and in particular on the~     improvement of the patients' quality of life as well as on the rate of complications of the~     device under investigation.~      The objective of this clinical investigation is to establish the feasibility, efficacy and~     safety of the TiLOOP® Bra.~   "
128446|NCT01886144|"~     Knee osteoarthritis (OA) is characterized by complaints of knee pain, aching and stiffness~     that commonly alter the way one will climb stairs and walk reducing an individual's function~     and the activities they may perform on a day-to-day basis. Providing a person with a knee~     brace designed for OA can help unload the arthritic part of the knee, thereby reducing pain~     and lead to improved function. The purpose of this study is to determine if use of the Rebel~     Reliever knee brace manufactured by Townsend Design can reduce pain and stiffness, improve~     strength and balance, and enhance functional activities such as stair and level gait, and~     ultimately lead to increased participation in the community.~   "
128447|NCT01886131|"~     To compare the electrical activity of SubThalamic Nuclei (STN), by mean of local field~     potentials recordings, during the phasic behaviours of RBD with the electrical activity~     recorded at this level during the execution of voluntary movements during the off and the~     on phases in patients with RBD secondary to PD.~   "
128448|NCT01886118|"~     One of the main factors in the success of in-vitro fertilization is the quality of the~     environment of the embryo. In contrast to maternal age, the environment in which the embryo~     develops is a modifiable factor. Many techniques, such as assisted hatching and perfecting~     culture media have been attempted in order to reproduce as much as possible the natural,~     physiological environment of the mother for the embryo in in-vitro fertilization. However,~     the different new culture media used are devoid of growth factors normally secreted by~     uterine cells that enhance the interaction between the embryo and its environment.~      Because the endometrial lining of the uterus secretes many different cytokines necessary for~     growth of the embryo, a new procedure has been developed to mimic the natural environment of~     the growing embryo using autologous (patient's own) endometrial cells in co-culture with the~     embryo. Endocell, a product developed by Genévrier Laboratories, received commercial~     authorization in France in 2011. It is the only system of autologous embryo-endometrium~     co-culture available on the actual market. The process consists of developing the embryo on a~     monolayer of the patient's own endometrial cells in order to favor its growth until the~     blastocyst stage (day 5) and to improve its implantation.~   "
128449|NCT01886105|"~     The primary goal of this study will be to examine tumor response after radiation treatment~     via a combination of Samarium-153 EDTMP and external beam radiotherapy.~   "
128450|NCT01886092|"~     Efficacy of different protocols of transcranial magnetic stimulation for the treatment of~     tinnitus~   "
128451|NCT01886079|"~     The purpose of study is to compare the incidence of acute kidney injury in patients receiving~     perioperative dexmedetomidine or placebo undergoing valvular heart surgery.~   "
128452|NCT01886066|"~     The standard of care for women with high risk endometrial cancer is the removal of all~     visible lymph nodes in the pelvis and lower abdomen to identify if disease has spread to~     these areas. It is estimated that no more than 25% of all women with presumed early stage~     high risk endometrial cancer will have positive lymph nodes however currently the majority of~     women are subjected to extensive resection of all pelvic lymph and or para-aortic lymph nodes~     and its associated morbidities. The objective of this study is to determine if intraoperative~     sentinel lymph node (SLN) mapping will improve the assessment of regional lymph nodes and~     enhance the detection of lymph nodes with metastatic disease in endometrial cancer. This~     would benefit the majority of women with early stage high risk endometrial cancer and would~     prevent the associated complications of pelvic lymph node dissection.~   "
128453|NCT01886053|"~     The purpose of this study is to evaluate the safety and Efficacy of Faropenem in~     community-acquired pneumonia (CAP) subjects，and explore its therapeutic dose.~   "
128454|NCT01886040|"~     Endometrial cancer is the second common gynecologic malignancy in Taiwan. The prevalence has~     been overcome the epithelial ovarian cancer because of the change of life style to western~     style recently. Most patients with endometrial cancer are stage I & II, the most histology is~     still endometrioid adenocarcinoma (type I endometrial cancer). In statistics, advanced~     stage (FIGO stage III and IV) is approximately 16% of all cases.~      Most patients has good outcome of endometrial cancer because their surgical stage is belonged~     to early stage. However, the recurrence, distant metastases and mortality are high if the~     diseases is confirmed to be advanced stage. The adjuvant therapies after staging/debulking~     operation are systemic chemotherapy and whole pelvic radiation therapy/ brachytherapy.~     Whether the adjuvant therapy can cure the disease of not is still controversial.~      Because of the rarity of the advanced endometrial cancer, varies adjuvant therapeutic~     modalities, eg. chemotherapy only, pelvic radiation therapy only, combination of chemotherapy~     and radiation therapy or sequential sandwich therapy were ever used for such group patients~     in each medical center. But the case number is insufficient and limited to show the survival~     or progression free benefit during the statistics. Besides, the surgical procedures and~     adjuvant therapy for early endometrial cancer is still remained to be determined. The~     investigators are also interested to analyze the factors affecting their survival.~      The investigators will perform a retrospective study to review the data of patients with~     endometrial cancer in Department of Obstetrics & Gynecology in Far Eastern Memorial Hospital.~   "
128455|NCT01886027|"~     The primary goal of this study is to test the efficacy of emotional awareness and expression~     training (EAET), a novel emotional processing intervention that the investigators have~     developed, for people with IBS. In this randomized, controlled trial, the investigators will~     compare EAET to a standard intervention that teaches the conceptually opposite~     approach—relaxation training (RT)—and test how both of these interventions compare to a~     wait-list control condition. The investigators hypothesize that individuals in the EAET group~     will demonstrate greater improvement in their IBS symptom severity, psychological~     functioning, quality of life, and health care utilization at 4 and 12-week follow-up time~     points, compared to individuals in the wait-list control group. It is also expected that both~     of the active interventions (EAET and RT) will be more efficacious than the wait-list control~     condition.~   "
128456|NCT01886014|"~     Placebo responses contribute to medical treatment outcome. The purpose of this study is to~     determine whether a single intranasal application of oxytocin can increase the placebo~     response in an experimental model of placebo analgesia in healthy volunteers.~   "
128611|NCT01883999|"~     The Iliac Branch Endoprosthesis (IBE) 12-04 study will be a prospective, nonrandomized,~     multicenter, single-arm evaluation designed to assess the safety and efficacy of the IBE~     Device in subjects with common iliac artery aneurysms (CIAA) or aorto-iliac aneurysms (AIA).~   "
128457|NCT01886001|"~     Umbilical catheters are necessary for many infants admitted to the Newborn Intensive Care~     Unit (NICU)and utilized when indicated for up to 7 to 14 days. Bacterial colonization can~     occur at the umbilical stump and potentially lead to serious bloodstream infections (BSIs).~     This study is a prospective, randomized controlled feasibility trial to evaluate three types~     of hygiene products on umbilical line stumps, on the effect of line colonization and~     subsequent infections. Infants admitted to the NICU with an umbilical line(s) will be~     randomized into one of four study groups, three products against standard of care (no~     product). The three products that will be evaluated are currently being used in different~     capacities for skin care in the UVA NICU. The study hypothesizes that daily topical~     application of 1 or more antiseptic to the top of the umbilical stump will decrease~     colonization of the umbilical stump while umbilical lines are in place.~   "
128458|NCT01885988|"~     The study will take part at The Men's Health Center It will involve men who have a diagnosis~     of erectile dysfunction and also have high blood pressure.~      High blood pressure can affect the lining of the arteries and cause stiffness in the~     arteries. The arteries and veins throughout the body have a lining called the endothelium~     which gives them the ability to stretch. If the lining of the penile arteries becomes~     impaired, it can decrease the stretching of the artery and decrease blood flow. Decreased~     blood flow in the penile arteries can cause problems obtaining an erection.~      The study medication Nebivolol controls blood pressure by relaxing smooth muscle around the~     lining of the arteries, thereby improving stretch and blood flow.~      The primary objective is to determine if treatment with nebivolol improves endothelial~     function and erectile function in men with pre-hypertension and stage 1 hypertension~      70 men will be enrolled into the study. Half of the subjects will receive active medication~     and half will receive a placebo. All men will receive educational informational handouts~     about blood pressure and behavior modifications to improve blood pressure. The study will~     last for 3 months for each subject. The expected recruitment time is one year, with a 2 year~     study completion goal. Subjects will have approximately 5 study visits.~      Subjects will have initial/final blood work, a Rigiscan test (a take home penile erection~     test), two EndoPat tests to assess endothelium function, 3 SphygmoCor tests to assess central~     blood pressure, 2 sexual health questionnaires at 2 visits. Vital signs will be monitored at~     each visit to assess safety and effectiveness of the study medication.~   "
128459|NCT01885975|"~     The investigators' hypothesis is that patients with apical ballooning syndrome (ABS) will~     manifest a personality profile that differs than that of a population of similar range of~     ethnic and socioeconomic status.~   "
128460|NCT01885962|"~     The investigators propose to test the feasibility of iSHIFTup (Internet Skin Health~     Intervention For Targeted Ulcer Prevention) for adults with spinal cord injury (SCI) to~     prevent serious pressure ulcers (PrUs) and promote protective health behaviors. This protocol~     is Phase 2 of a three phase project. In Phase 1, the investigators developed iSHIFTup. In~     Phase 2, the investigators will test the intervention by partnering with Woodrow Wilson~     Rehabilitation Center (WWRC) to conduct a randomized controlled trial (RCT) of 18~     participants. In Phase 3, the investigators will focus on optimizing the intervention based~     on our outcome findings and feedback, sustaining the program at WWRC, and seeking future~     funding for a larger RCT.~      The investigators will conduct an RCT of up to 18 participants (9 participants in treatment~     as usual (TAU) group, 9 participants in TAU + iSHIFTup intervention group) (18 participants~     are needed to obtain statistically significant results).~      The investigators will meet with potential participants in-person to complete the informed~     consent process and confirm eligibility. Participants in the TAU+iSHIFTup group will use the~     program during the study period. Participants randomized to TAU will have usual treatment~     during the study period and an opportunity to use the program following trial participation.~     The investigators will collect information from participants at two times during the study,~     at enrollment and post-intervention at 6-weeks (42 days). The investigators will also collect~     qualitative information from participants in the TAU+iSHIFTup group, during an optional~     focus-group setting, to learn users' experiences with the program. The investigators expect~     participants in the TAU+iSHIFTup group as compared to the TAU group, to display greater~     awareness of personal risk for pressure ulcers; increased preventive behaviors; and increased~     skin care self-efficacy and knowledge.~   "
128461|NCT01885949|"~     This research study is a Phase II clinical trial, which tests the safety and effectiveness of~     an investigational combination of drugs to learn whether they work in treating a specific~     cancer. Investigational means that the combination of drugs is still being studied and that~     research doctors are trying to find out more about it, such as the safest dose to use and the~     side effects they may cause. It also means that the FDA has not yet approved the combination.~      The two drugs being tested in this study are tivozanib and enzalutamide. Enzalutamide has~     been approved by the FDA for treatment of prostate cancer. On the other hand, tivozanib is~     still investigational, and has not been tested in a combination with enzalutamide before.~      Enzalutamide is an androgen receptor antagonist (it blocks the activity of the male sex~     hormones). Prostate cancers are initially dependent on the male hormone testosterone for~     growth. Hormonal therapies that lower testosterone or block the ability of testosterone to~     act at the level of the prostate cancer are currently among the most effective treatments for~     prostate cancers taht have spread to other body organs (metastasized). The effectiveness of~     hormonal treatments, however, is not permanent, and over time many prostate cancers progress~     in spite of these treatments. Enzalutamide is a drug that has been proven to help delay the~     progression of advanced prostate cancer on average for about 8 months.~      Tivozanib is an anti-angiogenesis medicine that fights different types of cancer by blocking~     the blood supply to the tumor, so that the tumor does not receive the nutrients it needs to~     grow. The main goal of this study is to determine whether the combination of tivozanib and~     enzalutamide is more effective in delaying the progression of disease than when enzalutamide~     is given alone. This study will also determine whether treatment with the combination of the~     tivozanib and enzalutamide will have more side effects then treatment with enzalutamide~     alone.~   "
128462|NCT01885936|"~     In this study the study team proposes to investigate the efficacy of albuterol on motor~     function of individuals with Late Onset Pompe Disease (LOPD) who are receiving enzyme~     replacement therapy, given albuterol was well-tolerated in patients with Late Onset Pompe~     Disease.~   "
128463|NCT01885923|"~     THE AIM OF THE PROJECT The main aim lies in the prevention of frequent relapses typical for~     schizophrenia and schizoaffective disorder by means of simple, highly cost-effective~     information technology-aided approach RESEARCH HYPOTHESIS A the end of 18 months study~     duration, patients in the active group enrolled in ITAREPS will demonstrate statistically~     significantly reduced risk of hospitalization, decreased number of hospitalization days and~     reduced direct inpatient costs in comparison to control group not using the program.~   "
128464|NCT01885910|"~     This pilot study will explore if continuation of treatment of treatment with Aczone 5% gel~     following combination treatment with with doxycycline and Aczone 5% gel can maintain~     therapeutic response.~   "
128487|NCT01885611|"~     To date, there has been no clinical investigation on the effects of virgin coconut oil (VCO)~     oral supplementation on patients with Hansen's disease (HD) undergoing medical treatment.~     This study aims to examine the possible protective effect of exogenous supplementation of VCO~     on the oxidative stress, antioxidant status, and treatment response among HD patients.~     Treatment response will be defined as the clinical changes in cutaneous and neurologic~     manifestations as measured by the clinical response score. This study also aims to~     investigate the potential of VCO as an adjunct to Multi-Drug Therapy (MDT) in mitigating~     lepra reactions.~   "
128488|NCT01885598|"~     The primary objective of this study is to examine the safety profile of Eliquis in Korean~     nonvalvular atrial fibrillation patients.~   "
128465|NCT01885897|"~     This is a multi-center, phase I/II clinical trial for patients who have relapsed more than 60~     day after allogeneic transplant for a hematologic malignancy. The study consists of two~     phases. The dose finding phase is a modified version of a phase I trial and the extended~     phase is a modified version of a phase II trial.~      The primary objective of the dose finding phase is to determine the maximum tolerated,~     minimum efficacious dose (MTD/MED) of a interleukin-15 (IL-15) super agonist complex~     (ALT-803) when given once weekly for 4 weeks in the outpatient setting. The study will follow~     a standard 3+3 design of dose escalation for toxicity with an added feature of stopping early~     if efficacy is confirmed. There are six dose levels of ALT-803 for to determine the MTD/MED:~     1, 3, 6, 10, 20, and 30 mcg/kg.~      Once the MTD/MED for ALT-803 is determined, this cohort will be used in the extended phase.~     The primary goal of this extended phase is to study the potential efficacy of ALT-803 in this~     patient population. Efficacy will be measured using rates of remission induction. An optimal~     Simon's two-stage design will be used in this phase. Stage 1 will enroll 14 patients~     (including the 6 patients treated at the MTD/MED during the dose finding phase). If 3 or more~     of these 14 patients respond to ALT-803, the trial will move to stage 2 and enroll an~     additional 23 patients. If 2 or fewer respond, the study will terminate enrollment early.~   "
128466|NCT01885884|"~     This is a pilot, randomized controlled trial of an embedded collaborative model of supportive~     care designed to improve quality of life and decrease use of unwanted healthcare services at~     the end of life for patients with advanced pancreatic cancer. We will enroll 30 patients who~     are receiving treatment at the Hillman Cancer Center for recently diagnosed, locally advanced~     or metastatic pancreatic adenocarcinoma, as well as their accompanying caregivers and~     providers. Patients will be randomized to receive either the supportive care intervention or~     usual care. The purpose of this study is to refine an embedded collaborative model of~     supportive care and to develop protocols for recruitment, randomization, and longitudinal~     data collection.~   "
128467|NCT01885871|"~     The purpose of this study is to determine whether picosecond laser is effective in the~     treatment of age (sun) spots.~   "
128468|NCT01885858|"~     This study is designed as a crossover randomized controlled trial, to investigate the effects~     of client's ethnic characteristics on the quality of family planning services.~   "
128469|NCT01885845|"~     Postpartum hemorrhage is one of the most common causes of maternal mortality and serious~     maternal morbidity, especially in the developing world. In India, hemorrhage is a major cause~     of maternal mortality: A study by the Register General in 1993 showed that 23 percent of all~     maternal deaths in rural areas were caused by hemorrhage (Sibley, 2005).~      The measurement of postpartum blood loss and identification of postpartum hemorrhage are~     important measures in efforts to prevent and treat postpartum hemorrhage. In recent years,~     researchers have employed several different methods to measure blood loss in hospital and~     community-based birth settings. Although research has demonstrated that these laboratory~     measures are more accurate then visual estimation techniques, no studies have explicitly~     documented the systematic differences (if any) among different collection modalities.~     Moreover, only a few of these studies have correlated measured blood loss with changes in~     hemoglobin levels experienced between the antepartum and postpartum period. The aim of this~     study is to compare variations in the measurement of blood loss obtained using two popular~     measurement methods: the Excellent BRASSS-V Drape™ and a modified version of the blood~     collection method developed by the World Health Organization (WHO).~   "
128470|NCT01885832|"~     Autologous stromal vascular fraction (SVF) injected into joints of 20 patients with grade 2,~     3, or 4 radiographic OA severity will be safe and feasible as assessed by lack of treatment~     associated adverse events. Improvements in joint function as assessed by Western Ontario and~     McMaster Universities Osteoarthritis Index (WOMAC) are anticipated.~   "
128471|NCT01885819|"~     Autologous stromal vascular fraction (SVF) injected at 8 and 10 days after extraction is safe~     and useful procedure in inducing remission of RA in patients resistant to standard DMARD~     therapy.~   "
128472|NCT01885806|"~     We aim to evaluate the safety and efficacy of repetitive transcranial magnetic stimulation~     (rTMS) for apathy treatment in patients with Alzheimer's disease (AD). We hypothesize that~     rTMS will be superior to placebo to reduce apathy symptoms and severity in patients with AD.~   "
128473|NCT01885793|"~     This is a prospective study looking at ways to measure the cuff pressure of cuffed~     endotracheal tubes (ETTs). We will be comparing a hand-held manometer (MM) to the transducer~     of an invasive pressure monitoring setup (IPMS), which is commonly used for arterial or~     central venous pressure monitoring. The investigators previously did this study in vivo with~     ETTs in polyvinyl chloride (PVC) tracheas and we found that there is good correlation~     between the pressure readings using the MM and the IPMS. The purpose of the current study is~     to validate the in vitro findings in clinical situations.~   "
128474|NCT01885780|"~     This clinical phase IV study is an open, prospective phase IV study and acts to evaluate the~     effectiveness of the femtolaser-assisted astigmatic keratotomy.~   "
128475|NCT01885767|"~     The NF Registry is a database of patient-reported experiences of living with~     neurofibromatosis. It also serves as a referral source for clinical trials.~   "
128485|NCT01885637|"~     Danish studies have shown that the majority of palliative cancer patients wish to be cared~     for and spend the rest of their lives at home. Nevertheless > 50% of palliative cancer~     patients die in acute hospitals and these figures are found in countries with a highly~     developed palliative care service as well. Some studies have suggested that, among other~     causes, delays in the discharge process represent a significant obstacle for achieving care~     and treatment, and ultimately death at home. Therefore, this randomized controlled trial~     (RCT) aims at investigating an accelerated transition program from oncological treatment to~     continuous specialized palliative care at home for patients with incurable cancer. The~     primary objective of the study is to investigate whether an accelerated transition from~     oncology care to palliative home care significantly increases home care and death. The~     secondary objectives are to investigate whether the intervention improves symptom control and~     quality of life, increases survival, affects health care expenses, improves caregiver quality~     of life and burden, dyadic coping and grief outcomes. The study will take place in the~     departments of oncology at Rigshospitalet, where palliative cancer patients will enter the~     intervention or usual care arms. The intervention is an accelerated transition program, which~     consists of planning palliative home care and if needed optimization of facilities at home,~     and a transfer to home care within 5 days of informed consent. On day 1 at home the patient,~     informal caregiver, nurse, representatives of the specialized palliative care team and if~     possible the general practitioner and project psychologist meet to organize home care. A~     dyadic psychological intervention is offered to patients and their informal caregiver during~     specialized palliative care at home and to bereaved caregivers. The control group will be~     treated according to the usual principles, but if inadequate palliative care is observed in~     this group, the study group is obliged to involve responsible professionals. Both groups will~     be followed by assessments of the patient and the caregiver for up to 6 months and the~     caregivers 19 month after the patient's death.~   "
128476|NCT01885754|"~     Rationale: With 1.6 million new cases diagnosed each year and 1.3 million deaths, lung cancer~     is the leading cancer-related death worldwide and it represents a pressing health issue.~     Patients with lung cancer are more likely to experience cachexia, a severe debilitating~     disorder causing fatigue, weight loss, muscle wasting and associated with reduced physical~     function, increased chemotherapy toxicity and reduced survival. This syndrome occurring in~     about 80% of advanced cancer patients is the direct cause of death in about 20% of cases.~     However, despite the importance of cachexia in lung cancer, its mechanisms ans its relation~     with muscle function and effort tolerance are still unknown.~      Aim: To explore muscle function, signaling pathways and its relationship to impaired~     functional capacity of patients with non-small-cell lung cancer(NSCLC); depending of whether~     they have cachexic state at diagnosis.~      Methods: This study will be conducted at the Institut universitaire de cardiologie et de~     pneumologie de Québec. 56 patients newly diagnosed of NSCLC will be recruited and separated~     whether or not they have a cachexic state. The evaluation will need two visits separated by 5~     days.~      During the evaluation the following tests will be done:~        -  Anthropometric measures~        -  Level of daily physical activity~        -  Pulmonary function test~        -  Maximal incremental cardiopulmonary exercise test on ergocycle~        -  Endurance test on ergocycle~        -  Muscle function tests~        -  Magnetic stimulation~        -  Quadriceps biopsy~   "
128477|NCT01885741|"~     A preliminary demonstration of the Safety of IPBS in positioning a vacuum assisted biopsy~     (VAB) tool to enable an MRI-guided automated breast biopsy. This will consist of 10-15 biopsy~     procedures facilitated by the MRI-guided system. Patients will be followed after the~     procedure to assess clinical outcomes.~   "
128478|NCT01885728|"~     The primary objective of this study is to characterize the immune-modulatory effects of~     arginine-rich nutritional supplements in patients undergoing surgery. Numerical and~     functional changes of all circulating immune cells will be assessed with mass cytometry.~   "
128479|NCT01885715|"~     This study aims to find appropriate dose of neostigmine which is possible to reverse~     rocuronium or cisatracurium till train of four (TOF) 0.9 within 10 minutes.~   "
128480|NCT01885702|"~     Objectives:~      In this Radboud University Nijmegen Medical Centre (RUNMC) initiated study our first~     objective is to investigate toxicity (safety and feasibility) of vaccination with~     frameshift-derived neoantigen-loaded DC of CRC patients with an MSI-positive CRC and persons~     who are known to be carrier of a germline MMR-gene mutation with no signs of disease yet.~      The secondary objectives of the study are:~        -  to demonstrate that peptide-loaded DC can induce or enhance an immune response to~          tumor-associated antigen CEA and specific frameshift-derived neoantigens in the study~          population.~        -  to study the pathological and clinical responses, e.g. disease-free survival, determined~          according to the standard protocol.~      Study design:~      This study is a phase I/II open-label study.~      Study population:~      Two groups of adults will be vaccinated:~      Group I) CRC patients, who are known to carry a germline MMR-gene mutation and patients with~     an MSI-positive CRC and yet unknown or negative MMR-gene mutation status.~      Group II) persons who are known to be carrier of a germline MMR-gene mutation with no signs~     of disease yet. All participants need to be HLA-A2.1 positive.~   "
128481|NCT01885689|"~     This phase II trial studies how well clofarabine and melphalan before a donor stem cell~     transplant works in treating patients with a decrease in or disappearance of signs and~     symptoms of myelodysplasia or acute leukemia (disease is in remission), or chronic~     myelomonocytic leukemia. Giving chemotherapy, such as clofarabine and melphalan, before a~     donor stem cell transplant helps stop the growth of cancer cells. It may also stop the~     patient's immune system from rejecting the donor's stem cells. When the healthy stem cells~     from a donor are infused into a patient they may help the patient's bone marrow make stem~     cells, red blood cells, white blood cells, and platelets. Giving clofarabine and melphalan~     before transplant may help prevent the cancer from coming back after transplant, and they may~     cause fewer side effects than standard treatment.~   "
128482|NCT01885676|"~     -  Androgenetic alopecia (AGA) or common baldness is the most common cause of hair loss in~          both men and women and is caused by the action of androgens in genetically predisposed~          individuals.~        -  This clinical trial was designed to evaluate the efficacy and safety of using a~          preparation of autologous plasma rich in growth factors (PRGF-Endoret) in the treatment~          of androgenetic alopecia.~   "
128483|NCT01885663|"~     This open label trial is conducted to investigate the efficacy and safety of allogeneic~     umbilical cord blood (UCB) therapy for patients with acquired brain injury.~   "
128484|NCT01885650|"~     Cystic Fibrosis (CF) is a genetic disorder of altered ion transport across cell membranes~     which is characterised by the production of thickened bodily secretions, affecting the~     function of organs such as the pancreas and the lungs. Within the lungs, thickened sputum is~     very difficult to clear, which can results in recurrent chest infections, which can lead to~     lung damage. therefore it is important to optimise the removal of sputum to try and prevent~     these complications. Traditionally, a variety of approaches are usually combined including~     inhaled medications to thin or hydrate secretions, and chest physiotherapy to mobilise~     secretions and improve sputum clearance.~      There are many chest physiotherapy or airway clearance techniques (ACT) available including~     breathing methods such as the Active Cycle of Breathing Techniques (ACBT) or Autogenic~     Drainage (AD) and adjuncts such as Positive Expiratory Pressure (PEP), High Frequency Chest~     Oscillation (the Vest), or oscillatory devices such as the Flutter or Acapella. When people~     with CF have an infection or have severe disease often the effectiveness of ACTs can decrease~     due to fatigue, shortness of breath or having an overwhelming amount of sputum. At this time~     it is necessary to re-assess ACTs and the addition of positive pressure to airway clearance~     techniques has been shown to be helpful in decreasing fatigue during chest physiotherapy.~      At present no research studies have reported an increase in sputum cleared with the addition~     of positive pressure, however it is thought that the ability to take a deeper breath when~     using positive pressure would help to improve sputum clearance. With clinical experience of~     the use of NIV with adult CF patients, the investigators aim to explore this objectively in~     this study.~      Research Question:~      Does the addition of non-invasive ventilation (Breas, I-Sleep 25) as supplementary positive~     pressure to normal airway clearance techniques improve sputum clearance in stable adult~     patients with cystic fibrosis?~      Hypothesis~      The inclusion of non-invasive ventilation in addition to a patient's normal airway clearance~     technique will lead to improvements in subjective ease of clearance and work of breathing~     during airway clearance and objectively increase sputum clearance, as well as being well~     tolerated in patients as an adjunct to airway clearance.~   "
128486|NCT01885624|"~     The purpose of this study is to assess safety and tolerability of ascending dosed of TAB08~     after single i.v. infusion to the adult healthy volunteers. Additionally were assessed~     infusion speed tolerability, pharmacokinetics and pharmacodynamics of TAB08 after single i.v.~     infusion and to explore TAB mechanism-of-action biomarkers.~   "
128489|NCT01885585|"~     The objective of this regulatory Post-Marketing Surveillance in Korea is to reconfirm the~     clinical usefulness of Eliquis through collecting, reviewing, identifying and verifying the~     safety and effectiveness information about Eliquis in general practice~   "
128491|NCT01885559|"~     The efficacy of interruption of the renin-angiotensin-aldosterone system (RAAS) on the~     progression of cystic disease and on the decline in renal function in autosomal dominant~     kidney disease (ADPKD) will be assessed in two simultaneous multicenter randomized clinical~     trials targeting different levels of kidney function: 1) early disease defined by GFR >60~     mL/min/1.73 m2 (Study A); and 2) moderately advanced disease defined by GFR 25-60 mL/min/1.73~     m2 (Study B). Participants will be recruited and enrolled, either to Study A or B, over the~     first three years. Participants enrolled in Study B will be followed for five-to-eight years,~     with the average length of follow-up being six and a half years.~      Combination therapy will use angiotensin-converting-enzyme inhibitor (ACE-I) and an~     angiotensin-receptor blocker (ARB). Monotherapy will use ACE-I alone.~   "
128492|NCT01885546|"~     This enhanced meter feature raises awareness among patients by providing additional~     information regarding their glycemic control between Healthcare Professional visits. This~     information may facilitate increased dialogue between patient and Healthcare Professionals~     and can remind patients of the importance of glycemic control.~      This study will evaluate a user's ability to obtain the enhanced meter feature.~   "
128493|NCT01885533|"~     Thyroid dysfunction following radioiodine for Graves' disease is common, potentially~     detrimental and avoidable. A variety of clinical strategies are employed in the~     post-radioiodine era util the patient is on a stable thyroid hormone replacement regimen,~     which include the use of anti-thyroid drugs, antithyroid drugs with thyroxine, early~     thyroxine replacement and watchful monitoring until the onset of hypothyroidism. Which of~     these is most effective in avoiding dysthyroidism, is unknown. This study aims to address~     this lack of evidence. It will focus on Graves' disease as this is the commonest cause of~     thyrotoxicosis and the commonest indication for RI therapy. It will provide an insight into~     potential strategies for improving important clinical outcomes.~   "
128494|NCT01885520|"~     The purpose of this study is to evaluate the food effect on the pharmacokinetics of eperisone~     HCl SR tablet~   "
128495|NCT01885507|"~     Protective ventilation (association of a tidal volume < 8 ml/kg with a positive end~     expiratory pressure) is poorly used in severe brain-injured patients. Moreover, a systematic~     approach to extubation may decrease the rate of extubation failure and enhance outcomes of~     brain-injured patients.~      We hypothesized that medical education and implementation of an evidence-base care bundle~     associating protective ventilation and systemic approach to extubation can reduce the~     duration of mechanical ventilation in brain-injured patients.~   "
128496|NCT01885494|"~     AFF008E is set-up to assess the long term effects of the 4 PD01A vaccinations that have been~     applied during AFF008 with regard to safety as well as immunological-, radiological and~     clinical activity. Accordingly, during AFF008E, no further vaccine dose will be applied.~     Instead, patients who were participating in AFF008 will be assessed for another 52 weeks at~     the occasion of 4 quarterly visits. This is offered to patients who received PD01A~     vaccinations but also to the patients who served as controls in AFF008. Thus, AFF008E will~     ensure standardized and controlled management of individuals who have received PD01A as part~     of AFF008, the Phase I study analyzing for the first time in humans this first in class~     candidate.~   "
128497|NCT01885481|"~     Particle steroid drug such as triamcinolone has been used widely for epidural steroid~     injection (ESI) treatment in Korea. However, Korea FDA recently prohibit ESI using~     triamcinolone, following the regulation of US FDA. Therefore, dexamethasone and betamethasone~     become only candidate drugs for ESI in Korea and the investigators are curious about the~     effectiveness and safety of both drugs due to limitation of information about comparison of~     two drugs in previous literature. So, this study aims to compare the effectiveness and safety~     of both drugs and our hypothesis is that there is no difference of the effectiveness between~     dexamethasone and betamethasone at 2 weeks after ESI.~   "
128498|NCT01885468|"~     This study is to verify the use of a hand held tool to verify the new setting of a~     hydrocephalus shunt (proGAV). This tool would be used in place of an Xray of the patient's~     head, which is how settings are verified currently.~   "
128499|NCT01885455|"~     This is a randomized, interventional trial in which the navigation is the intervention. Phase~     is not applicable. The study is a randomized trial to evaluate the impact of a nurse-led~     patient navigation intervention in improving rates of receipt of lung-directed therapy with~     curative intent (LDTCI) among African Americans with early stage lung cancer. Study sites are~     cluster-randomized to either the usual care study arm or the to the navigation intervention~     study arm. Randomization occurred at the level of the study site rather than at the level of~     individual participants. There are two arms.~   "
128500|NCT01885442|"~     Background: Patients in the intensive care unit (ICU) are the sickest in hospital, and need~     advanced life-support. Survivors of critical illness are very vulnerable to weakness and~     disability. Up to 1 in 4 have severe leg weakness impairing their quality of life for as long~     as 5 years after ICU discharge. In-bed cycling employs special equipment that attaches to a~     patient's hospital bed, allowing them gentle leg exercise while in the ICU. The investigators~     will offer patients in-bed cycling while they are needing a breathing machine, to help them~     recover from weakness as fast as possible. Before doing a larger trial testing if in-bed~     cycling reduces disability, data on safety (Is it safe?) and feasibility (Can the~     investigators do it?) are needed.~      Objectives: To study the safety and feasibility of in-bed leg cycling in critically ill~     patients who need breathing machines.~      Methods: Adult patients admitted to the ICU who need a breathing machine and are expected to~     survive their ICU stay are eligible. Specially trained physiotherapists will provide patients~     with 30 minutes of in-bed cycling each day while they are in the ICU.~      Outcomes: The investigators will study (1) Safety: the heart rate and breathing patterns of~     patients doing in-bed cycling, while carefully monitoring for safety. (2) Feasibility:~     whether patients can cycle on most days of their ICU stay, whether patients and their~     families agree to be a part of the study, and whether the investigators can assess patients'~     strength in the ICU and at hospital discharge.~      Relevance: As the Canadian population ages, the demand for breathing machines during acute~     illness will increase dramatically. Effective methods of physiotherapy are needed for~     critically ill patients to minimize muscle weakness, speed recovery, and improve quality of~     life. This pilot study is the first of several future larger studies about in-bed cycling in~     the ICU. This program of research will help patients needing life support to regain their~     strength and recover as fast as possible from critical illness.~   "
128525|NCT01885117|"~     The present study is designed to confirm the safety and immunogenicity of trivalent, surface~     antigen, inactivated influenza vaccine in 2 age cohorts: 18 to ≤60 years and ≥61 years and~     the antibody response to each influenza vaccine antigen, as measured by Single Radial~     Hemolysis (SRH) or Hemagglutination Inhibition (HI) at approximately 21 days post~     immunization.~      The vaccine composition will be based on the World Health Organization (WHO) recommended~     influenza strains for the 2013/2014 Northern Hemisphere vaccine.~      The results of this study are intended to support the use of this vaccine in future influenza~     seasons if the recommended vaccine composition remains the same, in compliance with the~     requirements of the current European Union (EU) recommendations for clinical trials related~     to yearly licensing of influenza vaccines.~   "
128501|NCT01885429|"~     Muscle mass is normally maintained through the regulated balance between the processes of~     protein synthesis (i.e. making new muscle proteins) and protein breakdown (breaking down old~     muscle proteins). Proteins are composed of amino acids and we know that amino acids increase~     muscle protein synthesis. However, not all amino acids are the same. Essential amino acids~     are ones that must be consumed through food, while non-essential amino acids can be made by~     our body. Interestingly, the essential amino acids are all that are required to increase the~     rate of muscle protein synthesis. In addition, the essential amino acid leucine appears to be~     particularly important in regulating protein synthesis. However, how leucine is able to~     increase protein synthesis is not entirely understood. Previously, it has been shown that~     20-25 g of high-quality protein, such as that found in milk (whey), appears to be the amount~     of protein that maximizes the rate of muscle protein synthesis after performing a bout of~     resistance exercise. Thus, we aim to measure the synthesis of new muscle proteins after~     ingesting different amounts of protein and amino acids. We will measure muscle protein~     synthesis after consumption of the beverage a participant is randomized to in a leg that has~     done no exercise ( ie. a rested leg) and in the other leg that has done resistance exercise.~     Amino acids are 'strung-together' to make protein. The 'essential' amino acids must be~     consumed through food because our body cannot make them, thus they are consumed when you eat~     protein rich foods like milk or chicken. Leucine, isoleucine, and valine are simply 3 of the~     8 essential amino acids that make up dietary protein. Unlike essential amino acids,~     'non-essential' amino acids may be synthesized by the body, however they are also present in~     protein rich foods like chicken or milk. We aim to determine if it is the leucine content~     found in 25 g of whey protein that is primarily responsible for maximizing muscle protein~     synthesis at rest and following resistance exercise. We also wish to determine how muscle~     genes and metabolism respond to this protocol.~   "
128502|NCT01885416|"~     The study will quantitatively evaluate the systemic, postprandial inflammatory and metabolic~     response to the ingestion of three different meals in obese subjects. The administered meals~     will differ in the proportion of dairy products. Postprandial response will be monitored~     during 6 hours after meal consumption.~   "
128503|NCT01885403|"~     The aim of the study is to determine the feasibility of collecting respiratory parameters~     during recompensation following ADHF (Acute Decompensated Heart Failure)with non-invasive~     measurements. This could lead to a better understanding of how respiratory parameters may~     change during re-compensation therapy and could also be a comfortable method for patients.~   "
128504|NCT01885390|"~     The purpose of this registry is to evaluate the safety and performance of the ROX COUPLER in~     patients with treatment-resistant or uncontrolled hypertension.~   "
128505|NCT01885377|"~     Objective: A randomized clinical trial in order to evaluate the efficacy of a specific~     exercise strategy for patients with subacromial pain.~      Hypothesis:~      H1 - The three month specific exercise strategy has a satisfactory effect improving shoulder~     function and/or shoulder pain.~      H0 - No difference between the two exercise strategies (specific exercise strategy and active~     control exercises).~      Method: Patients attending primary care with subacromial pain are offered participation. If~     accepted, they will participate in a three month rehabilitation program. The duration of~     symptoms can vary from 2 weeks and longer. The patients will be randomized to either~     rehabilitation; the specific exercise strategy or active control exercises. All patients has~     an equal number of sessions with the physical therapist (PT) to offer similar attention and~     support with exercise performance. A blinded physical therapist evaluates the following~     outcomes at baseline and after three-, six and twelve months:~      Primary outcomes: Constant-Murley shoulder assessment (CM-score). Secondary outcomes;~     Disabilities of the Arm Shoulder and Hand questionnaire (DASH), different aspects of pain by~     Visual Analogue Scale (VAS), EuroQol-5D index (EQ-5D) and EuroQol-VAS (EQ-VAS), The Patient~     Specific functional Scale, and Patients' global impression of change (PGIC). Also sick-leave~     and return to work will be recorded. All patients are evaluated with a diagnostic ultrasound~     to reveal the status of the rotator cuff.~      Additional to the analysis of treatment effect on shoulder function and pain, factors~     influencing and explaining the CM-score at follow-ups will be analyzed.~      This study is warranted in order to evaluate if an earlier reported positive effect on~     shoulder function and pain with the specific exercise strategy, in patients on waiting list~     for subacromial decompression, can be repeated in the primary care population of patients~     with subacromial pain. There is no consensus about first-line exercises for patients with~     subacromial pain, and these positive results on pain and shoulder function need to be~     reproduced in primary care before they can be recommended and implemented. Further, knowledge~     about which factors that can be used in prediction rules for patients that will respond to~     the exercises or needs surgery is lacking.~   "
128506|NCT01885364|"~     Pain on injection of propofol is a common side effect. The present study was designed to~     investigate the effect of esmolol on pain on propofol injection and to compare it with~     remifentanil and placebo.~   "
128507|NCT01885351|"~     This study involves 3 phases that modifies current Interactive Preventative Health~     Record-Colorectal Cancer Screening (IPHR-CRCS) modules to address each patient's individual~     colorectal cancer screening (CRCS) knowledge, attitudes, preferences, and test-specific~     barriers. The study will engage patients, ages 50-75 years who are non-adherent to CRCS, to~     assess their CRCS test preferences and corresponding test-specific barriers in real time.~     Based on patient characteristics (e.g. age, personal and family history, physician CRCS~     recommendation, CRCS test preferences, top test-specific barriers), tailored messages/videos~     will appear in the pop-up screens to address/reduce the top patient-reported, test-specific~     CRCS barriers while incorporating an action plan for CRCS adherence. The investigators~     hypothesize that modifying the IPHR-CRCS module to address each patient's individual CRCS~     knowledge, attitudes, preferences, and test-specific barriers will further increase CRCS.~   "
128508|NCT01885338|"~     This study will evaluate the effect of the dietary supplement N-acetylcysteine (NAC) on~     electrophysiologic (EEG) markers related to cognition, as well as performance on~     psychological tests measuring cognition. The primary hypothesis is that participants treated~     with NAC will show improvements in cognitive function, as measured by EEG and~     performance-based tests.~   "
128509|NCT01885325|"~     The study addresses a critical public health problem, childhood obesity, by testing a~     physical activity intervention in the types of preschools that millions of children attend.~     Information gained in this study may lead to adoption of preschool policies and instructional~     practices that increase physical activity and reduce the risk of obesity in preschool~     children.~   "
128510|NCT01885312|"~     This study is designed to develop and test a tailored adaptive text messaging/short message~     service (SMS) intervention for individuals interested in stopping or reducing their alcohol~     consumption; and test and compare it to tailored but static, once a day messaging, gain~     framed messaging, and ecological momentary assessment only.~   "
128511|NCT01885299|"~     The RSSearch® Registry is an international multi-year database designed to track SRS/SBRT~     (Stereotactic Radiosurgery/Stereotactic Body Radiation Therapy) utilization, treatment~     practices and outcomes to help determine, over time, the most effective use of these systems~     in management of patients with life threatening tumors and other diseases. (This study was~     formally called ReCKord and included the CyberKnife only; The ReCKord study continues as a~     CyberKnife subset of RSSearch.)~   "
128512|NCT01885286|"~     The investigators are testing a novel surgical device to facilitate safe circumcision among~     adult males. The investigators hypothesize that this device will allow non-medical providers~     to perform safe surgical circumcision without adverse events.~   "
128526|NCT01885104|"~     The purpose of this study is to compare the safety and tolerability of oral ingestion of PEG~     3350 solution concentrate to oral ingestion of a placebo solution concentrate, in~     participants with constipation.~   "
128527|NCT01885091|"~     The purpose of the K.I.S.S. study is to evaluate the efficacy of Kinerase® Cream (Kinetin~     0.1%) in Thai patients, on the basis of the severity and clinical signs of facial~     photodamage.~   "
128513|NCT01885273|"~     The study is to examine the effectiveness of cleansing wound with pressurized irrigation~     method compared with conventional practice of swabbing on the wound healing and infection of~     acute and chronic wound, and to evaluate the patient's physical symptoms related to wound,~     patient's satisfaction to cleansing method, and cost of materials used between the two~     groups.~      Patients with acute or chronic non-sutured wounds as well as being eligible to exclusion~     criteria will be recruited and randomly assigned to be cleansed using either: pressurized~     irrigation method (experimental group) or swabbing method (control group).~      244 patients will be recruited in the study. This will take place in four community health~     centres run by the Hospital Authority in Hong Kong. The wounds of participants will be~     cleansed using the assigned method for a six week period. The clinic staff nurse is~     responsible for the ongoing assessment of the wound.~      Wound assessment will be undertaken at enrolment and upon healing of the wound or at the end~     of six-week period if the wounds have not healed. Demographic data and information related to~     the wound -wound size +/- wound volume, wound culture swab, and symptoms -wound discomfort,~     pain and odour will be collected at enrolment. Information related to the wound and~     subjective measures of patient satisfaction -feeling of cleanliness, liking, and of staff~     satisfaction -feeling user-friendliness, accessibility, cleanliness, liking to the cleansing~     method using VAS will be assessed at completion of treatment. A list of cost measurements for~     the wound cleansing would also be captured.~   "
128514|NCT01885260|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of ISIS-GCGRRx~     in combination with metformin versus placebo + metformin~   "
128515|NCT01885247|"~     The management of patients with Obstructive Chronic BronchoPneumopathy (OCBP) is based on a~     progression of therapeutic options and on a sensitization to physical activity.~      For these patients selected on OCBP stage 2, the treatment options include Long Acting~     Beta-Agonist Bronchodilator (LABA) or Long Acting Muscarinic Antagonist Anticholinergic~     (LAMA) or both (LAMA+LABA).~      The purpose of this study is to observe in common clinical practice the benefit of physical~     activity on quality of life, dyspnoea and walking distance for these patients under treatment~     (LABA and/or LAMA) and to determine whether these 3 medical strategies (LABA/LAMA/LABA+LAMA)~     benefit from physical activity.~   "
128516|NCT01885234|"~     The aim of the present study is verify glycated hemoglobin (HbA1c) and HOMA behavior in~     pregnant women with gestational diabetes or chronic hypertension after an aerobic training in~     cycle-ergometer. The sample is composed by 64 pregnant and sedentary women, 20 weeks'~     pregnant.~      Two experimental groups (gestational diabetes and chronic hypertension, n = 16 each) will~     perform a low-intensity aerobic training in cycle-ergometer, three times/week, for 45 minutes~     each session. Two control groups (gestational diabetes and chronic hypertension, n = 16 each)~     will perform an unique session/week of relaxation and stretching.~      Outcomes: first ventilatory threshold, HbA1c,HOMA, type of delivery, weight and height of the~     newborn.~   "
128517|NCT01885221|"~     In an earlier study, the investigators developed a guidebook that taught women supportive~     behaviors to help their husbands/partners quit smokeless tobacco. This study will create a~     website using the information in the guidebook, along with interactive features, videos, and~     forums. The investigators will then conduct a randomized trial comparing an intervention~     group (receiving website access and the printed guidebook) with a delayed treatment control~     condition, to learn if the support intervention can effectively teach women supportive~     behaviors and thereby increase their partners' smokeless tobacco cessation rates.~   "
128518|NCT01885208|"~     This trial is conducted in Europe and North and South America. The aim of the trial is to~     investigate the efficacy and safety of semaglutide once-weekly versus exenatide ER (extended~     release) 2.0 mg once-weekly as add-on to 1-2 oral antidiabetic drugs (OADs) in subjects with~     type 2 diabetes.~   "
128519|NCT01885195|"~     The purpose of this signal seeking study is to determine whether treatment with MEK162~     demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic~     malignancies to warrant further study~   "
128520|NCT01885182|"~     To Determine the Safety and Efficacy of Oxycodone / Naloxone Prolonged Release Tablets~     compared to Oxycodone PR in Subjects with Moderate to Severe, Chronic Cancer Pain~   "
128521|NCT01885169|"~     Influenza (the flu) is one of the most common respiratory viruses associated with~     respiratory deteriorations in children and adolescents with cystic fibrosis. These~     deteriorations usually mean antibiotics, hospitalizations, and worsening of pulmonary~     function tests. A new flu vaccine has been recently approved for use in Canada (Flumist®).~     What is particular about this flu vaccine is that it is a spray in the nose, which mimics how~     influenza usually infects us. This particular vaccine protects children and adolescents much~     better than the regular injectable flu shot.~      This new vaccine has been given to > 2,000 healthy children and to >2,000 children with~     asthma and well tolerated. The investigators want to know if Flumist® is well tolerated in~     children with CF and does not cause worsening of respiratory symptoms. The investigators will~     conduct a study where all participants will receive Flumist® in the nose. This study is~     particularly important because its results will provide safety information on a vaccine that~     is more efficacious for a population who needs safe and easy to administer protection against~     the flu.~   "
128522|NCT01885156|"~     To see how well Naftin 1% cream works when applied once daily to the affected area. The~     results will be compared to those using a placebo cream, which is a cream with no active~     ingredient. Safety will also be measured.~   "
128523|NCT01885143|"~     Collect clinical images requested by FDA with GE Breast Tomosynthesis to show they are of~     acceptable quality as defined in the relevant FDA guidance document before and after artifact~     correction and in standard screening images. Lossy compression will also be evaluated to~     demonstrate that images are of acceptable quality when lossy compression is enabled.~   "
128524|NCT01885130|"~     Determine if Cetaphil Daily Advance Ultra Hydrating Lotion proves to be a contact sensitizer~     or irritant in certain individuals.~   "
128528|NCT01885078|"~     The purpose of this study is to investigate the long-term safety and any side effects of~     baricitinib in participants who have completed a previous baricitinib rheumatoid arthritis~     study.~      The study provides for 7 years of additional treatment with baricitinib.~   "
128529|NCT01885065|"~     The purpose of this study is to determine whether continuous use of edible, gel-based~     artificial saliva in cancer patients with dry mouth problems will reduce signs and symptoms~     of dry mouth and improve quality of patients' saliva.~   "
128530|NCT01885052|"~     Background:~      - Researchers want to see how well the QuitTXT text-message program helps smokers ages 18 29~     stop smoking. This is part of a larger online stop-smoking program by the National Cancer~     Institute. The QuitTXT program is a 2-week countdown to the smoker s quit date with 6 weeks~     of follow-up messages. Program participants will receive texts on their cell phones,~     including tips, information, and motivational messages, and then fill out surveys.~      Objectives:~      - To study how well the QuitTXT program helps smokers ages 18 29 stop smoking.~      Eligibility:~      - Adults ages 18 29 who have smoked on at least 5 of the past 30 days and who want to stop~     smoking in the next 30 days.~      Design:~        -  Participants will receive a certain number of text messages during the 8-week study.~          They will receive between 0 to 5 messages per day (or up to a total of 130 messages).~        -  Participants will first fill out a survey about their smoking and quitting experiences.~          Then they will choose a date to quit smoking (a quit date ) between 2 and 3 weeks after~          this survey.~        -  Participants will take four other surveys online, one during the program and three more~          after they ve completed the program. Each survey will take about 10 20 minutes and asks~          about their smoking habits and views on smoking and quitting. Each survey will be sent~          by email, with reminders sent by email or telephone.~        -  Participants will receive an iTunes or Amazon gift card for completing each survey~          honestly.~   "
128531|NCT01885039|"~     Background:~      - The Chinese University of Hong Kong and the National Cancer Institute are conducting a~     breast tissue study in connection with another study on breast health. This larger study will~     look at breast health in women who live in Hong Kong. Women in the breast health study will~     provide a breast tissue sample during biopsy surgery. Researchers want to use part of the~     sample to study changes in breast tissue that are related to breast diseases. This sample~     study is part of the larger study.~      Objectives:~      - To look at changes in breast tissue that are related to breast diseases.~      Eligibility:~        -  Women who are participating in the Hong Kong breast health study.~        -  Participants must be having a biopsy to remove breast tissue for study.~      Design:~        -  Participants will have a biopsy to remove a breast tissue sample. Most of the sample~          will be used for diagnosis. A portion of the leftover tissue will be used for this~          study.~        -  No extra surgery will be required.~        -  Treatment will not be provided as part of this study.~   "
128532|NCT01885026|"~     Objectives: This study evaluates the efficacy of eScreen for internet psychiatry patients~     treated for major depressive disorder, panic anxiety and social phobia. The eScreen brief~     Internet intervention for problematic alcohol and drug use offers self-screening, in-depth~     self-reporting, personalized feedback and treatment recommendations as well as an electronic~     diary. Progress over time is shown in diagrams detailing consumption levels.~      Method: This is a two-armed randomized controlled design, measuring outcomes in terms of~     changes in problematic alcohol use up to one year after study recruitment. Participants with~     problematic alcohol use (AUDIT >7 for men and >5 for women) and/or problematic drug use~     (DUDIT > 1 for both men and women) are randomized into one of two groups: T1, eScreen~     referral or Control group. Outcomes on alcohol and drug use as well as health-related~     symptoms are assessed after 3, 6 and 12 months.~      The hypothesis is that the group receiving the eScreen intervention will reduce their~     alcohol/drug use to a larger extent than the control group at follow-up compared to the~     baseline level.~   "
128533|NCT01885013|"~     This is a phase II comparative randomized clinical trial.~      Eligible patients will be randomized (1:1) to:~      Arm A: Myocet plus Cyclofosfamide plus Metformin Arm B: Myocet plus Cyclofosfamide~      Statistical Considerations:~      In this randomized phase II study, the sample size was calculated basing on the primary~     end-point (PFS) and assuming an error α = 10% (2-tailed) with a power of 80%.~      To find an advantage of 4 months of median time to progression (6 months in the control arm B~     and 10 months in the experimental arm A) will be recruited 112 patients (98 events) for a~     period of 24 months and will be considered further 12-month of follow-up. The primary~     analysis of the study will be conducted in accordance with the intention to treat~     principle, the secondary analysis will be conducted in the per protocol population.~   "
128534|NCT01885000|"~     The purpose of the study is to evaluate the patient-reported outcomes (feedbacks of~     patients)of a new drug for the treatment of erythema of rosacea (central facial redness). The~     feedback of patients receiving the active drug will be compared to the feedback of patients~     receiving the placebo.~   "
128535|NCT01884987|"~     Cerebral radiation necrosis (CRN) is a well-documented late complication of radiation therapy~     for cancers, and may have a devastating effect on the patient's quality of life (QOL).~     However,CRN was once regarded as a progressive and irreversible disease, no standard therapy~     has been suggested for CRN. In our clinical practice, we have used~     monosialotetrahexosylganglioside (GM1)to treat CRN, and found that GM1 can successfully~     reverse CRN. So we carried out this prospective study to test the efficacy of GM1 for CRN.~   "
128536|NCT01884974|"~     Pulmonary hypertension (PH) is defined as a group of diseases characterised by an elevated~     mean pulmonary artery pressure (Ppa) ≥25 mmHg at rest. Recently, chronic myeloproliferative~     diseases (CMPD) associated with pulmonary hypertension were included in the group 5 category,~     corresponding to PH for which the aetiology is unclear and/or multifactorial. CMPD include~     chronic myelogenous leukaemia, chronic neutrophilic leukaemia and chronic eosinophilic~     leukaemia (which primarily express a myeloid phenotype and polycythaemia vera), idiopathic~     myelofibrosis, and essential thrombocytosis in which erythroid or megakaryocytic hyperplasia~     predominates.~      The purpose of this research:~        1. Assess Prevalence of PH in patients with CMPD in Northern Israel~        2. Describe the demographics and clinical course in patients with CMPD who are diagnosed~          with PH.~   "
128537|NCT01884961|"~     Title: Radiotherapy as an immunological booster in patients with metastatic melanoma or renal~     cell carcinoma treated with High-dose Interleukin-2: evaluation of biomarkers of immunologic~     and therapeutic response~      Phase: Proof of Principle phase II study~      Study Design: Single center, open-label trial to assess the immune response and potential~     biomarkers predictive of response~      Study Duration:~      Total duration: 36 months Enrollment: 20 months Treatment: 5 months per patient Follow-up~     every three months~      Number of Subjects:~      Mini-max two-stage Simon design:~      • Step 1: 7 patients enrolled~      If tumor antigen-specific immune response is observed in at least 3 patients:~      • Step 2: recruitment of an additional 12 patients~   "
128539|NCT01884935|"~     The primary objective of the study is to determine the pharmacokinetic (PK) profile of~     multiple doses of natalizumab in pediatric subjects with relapsing-remitting multiple~     sclerosis (RRMS). The secondary objectives are as follows: to characterize the~     pharmacodynamic (PD) profile of natalizumab (as defined by α4 integrin binding) and to~     explore the safety and tolerability of multiple doses of natalizumab in the pediatric~     population.~   "
128540|NCT01884922|"~     Multicenter, open label, prospective study including successively a phase I trial and then a~     phase II trial Phase I : Open label, non-randomized, sequential dose escalation of both~     drugs, vinblastine and nilotinib.~   "
128541|NCT01884909|"~     This is an open Label, randomized, two-period, two-treatment, two-sequence, crossover,~     balanced, single dose pivotal study. The purpose of this study is to assess the~     bioequivalence between Test Product and the corresponding Reference Product under fed~     condition in healthy adult human subjects.~   "
128542|NCT01884896|"~     This is an open Label, randomized, two-period, two-treatment, two-sequence, crossover,~     balanced, single dose pivotal study. The purpose of this study is to assess the~     bioequivalence between Test Product and the corresponding Reference Product under fasting~     condition in healthy adult human subjects.~   "
128543|NCT01884883|"~     The aim of this study is to confirm the biomechanical effects and evaluate functional~     benefits of a new knee brace combining valgus inducing effect on medial compartment and leg~     external rotation during the stance phase in patients with symptomatic medial knee~     osteoarthritis.~   "
128544|NCT01884870|"~     Ureteral stones may be silent in 5.3% of patients. The goal of this study was to~     prospectively evaluate the impact of a silent ureteral stone on renal function.~   "
128545|NCT01884857|"~     This is an open Label, randomized, two-period, two-treatment, two-sequence, crossover,~     balanced, single dose pivotal study. The purpose of this study is to assess the~     bioequivalence between Test Product and the corresponding Reference Product under fasting~     condition in healthy adult human subjects.~   "
128546|NCT01884844|"~     The purpose of this study is to whether vitamin d supplementation in those with low levels~     may reduce depression symptoms in people experiencing bipolar depression.~   "
128547|NCT01884831|"~     In Russia the treatment nonhealing skin defects often limited to surgical interventions,~     despite having developed modern methods of treatment of non-healing ulcers and other skin~     imperfections. During the many years of research we have developed a skin equivalent~     comprising living cells.~      During pilot trial showed that the skin equivalent provides healing skin defect within 1-4~     weeks in 95% of patients.~   "
128548|NCT01884818|"~     The study includes two phases. In phase one the reliability of thoracic spine mobility~     measurements are studied in subjects with thoracic spine pain. In phase two the reliable~     measurements are used to measure the effects of thoracic spine manipulation in subjects with~     thoracic spine pain. The changes in pain is measured as well.~      In second phase the control group receives TNS treatment six times at home as a placebo so~     that the power of TNS is limited to very low level. The number of treatments are controlled~     as well as the time of treatment. The treatment group receives six manipulation treatments~     within 3 week period. The effects are measured immediately after the treatment weeks, and 3~     and 8 week follow-up. Moreover the one year follow-up will be performed by mail~     questionnaire.~   "
128549|NCT01884805|"~     The primary purpose of the protocol is to evaluate the adaptive optics visual simulator to~     measure optical aberrations in hyperopic eyes.~      The study hypotheses are the:~        -  Ability to measure optical aberrations in hypermetropia.~        -  Knowledge of optical aberrations of the eye hyperopic.~        -  To adapt therapeutic management in optical aberrations measured.~   "
128550|NCT01884792|"~     The study is a crossover, pilot trial examining the acute effects of standing on blood sugar~     in prediabetic, working adults. Participants will complete oral glucose tolerance testing,~     once while sitting and once while standing. They will also wear a continuous blood sugar~     monitor once while sitting at their desk for a week and once while using their desk as a~     sit-stand desk with a goal of standing intermittently for at least half of the work day.~     Physical activity levels will be measured with an accelerometer. The primary study hypothesis~     is that blood sugar will differ between the sitting and standing conditions for each of the~     tests performed.~   "
128551|NCT01884779|"~     Histoplasma capsulatum var. capsulatum histoplasmosis is the leading cause of acquired~     immunodeficiency syndrome (AIDS) and death in French Guiana and probably in the Amazon. The~     diagnosis of this disease requires invasives procedures, laboratory performance, and delays~     up to several weeks. The Mycotic Diseases Branch of the Centers for Disease Control and~     Prevention (CDC) has established a rapid, sensitive and specific ELISA test for blood and~     urine samples that looks interesting in endemic areas, particularly in developing countries.~     The study aims to measure the proportion of HIV-infected patients hospitalized or in~     outpatient awaiting hospitalization for a suspicion of infectious syndrome whose serum and/or~     urinary antigen detection tests are positive for Histoplasma capsulatum var. capsulatum.~   "
128552|NCT01884766|"~     In many fields of medicine, except seizure disorders, blood biomarkers have captured an~     integrated part of diagnostic decision making, including copeptin, the surrogate marker of~     vasopressin release. There are strong arguments to hypothesize circulating copeptin is~     elevated in epilepsy, especially in generalized seizures such as fever seizures (FS), and~     that copeptin is predictive for complexity and relapse at least in FS. Although long-term~     morbidity and mortality are both low in FS, there is high anxiety among parents because of a~     lack of criterions to identify children at risk for relapse. Copeptin may fill this gap by~     adding important diagnostic and prognostic information. Eventually, less children may receive~     needlessly over years fever drugs or anti-epileptic drugs.~   "
128553|NCT01884753|"~     The main purpose of this study is to get the urethra and pelvic sonographic imaging by 4D~     ultrasound examinations, and to correlate the sonographic findings with urodynamic variables,~     pad weights and LUTS. Besides, the associations of the blood flow of vagina/urethra and~     sexual dysfunction can be explored.~   "
128612|NCT01883986|"~     The aims of this project are to assess the feasibility of recruiting patients and delivering~     a nurse-led telephone based palliative care intervention for patients with newly diagnosed~     lung cancer and to assess if among patients with newly diagnosed lung cancer, the~     investigators can estimate the effect of a nurse-led telephone based palliative care~     intervention on quality-of-life, symptom burden and patient satisfaction.~   "
128554|NCT01884740|"~     Central nervous system (CNS) malignancies are the second most common malignancy and the most~     common solid tumor of childhood, including adolescence. Annually in the United States,~     approximately 2,200 children are diagnosed with CNS malignancy and rates appear to be~     increasing. CNS tumors are the leading cause of death from solid tumors in children. Survival~     duration after diagnosis in children is highly variable depending in part on age at~     diagnosis, location of tumor, and extent of resection; however, most children with high grade~     glioma die within 3 years of diagnosis. All patients with high grade glioma experience a~     recurrence after first-line therapy, so improvements in both first-line and salvage therapy~     are critical to enhancing quality-of-life and prolonging survival. It is unknown if currently~     used intravenous (IV) therapies even cross the blood brain barrier (BBB). We have shown in~     previous phase I trials that a single Superselective Intra-arterial Cerebral Infusion (SIACI)~     of Cetuximab and/or Bevacizumab is safe for the treatment of recurrent glioblastoma~     multiforme (GBM) in adults, and we are currently evaluating the efficacy of this treatment.~     Therefore, this phase I/II clinical research trial is an extension of that trial in that we~     seek to test the hypothesis that intra-arterial Cetuximab and Bevacizumab is safe and~     effective in the treatment of relapsed/refractory glioma in patients <22 years of age. We~     expect that this project will provide important information regarding the utility of SIACI~     Cetuximab and Bevacizumab therapy for malignant glioma in patients <22 years of age and may~     alter the way these drugs are delivered to our patients in the near future.~   "
128555|NCT01884727|"~     To test the effect of ASEA consumption on 24-hour resting energy expenditure. Hypothesis:~     consumption of 8-oz of ASEA water (4-oz before breakfast and 4-oz before bedtime) will~     significantly elevate 24-h resting energy expenditure as compared to consumption of a placebo~     control (salt water, same dietary intake).~   "
128556|NCT01884714|"~     The purpose of this study is to better understand the genetic and metabolic differences in~     obese individuals with and without type 2 diabetes. It is expected that this research will~     help improve our understanding of the variability observed between obese and diabetic~     individuals.~   "
128557|NCT01884701|"~     The current study is a prospective, single-arm, non-randomized, multi-center study to~     evaluate the outcome of the ENABLER-P Catheter System for crossing chronic total occlusions~     during endovascular intervention for femoral-popliteal occlusive disease.~   "
128558|NCT01884688|"~     The purpose of this study is to determine the safety and in vivo persistence and expansion of~     autologous and expansion of autologous, ex vivo expanded-natural killer(ENK) cells.~   "
128559|NCT01884675|"~     It is hypothesised that ambrisentan may provide benefit to subjects with inoperable chronic~     thromboembolic pulmonary hypertension (CTEPH), where currently no proven or licensed~     treatment options exist. This Phase III, randomized, double-blind placebo controlled parallel~     group, 16 week study will compare the safety and efficacy of ambrisentan 5 milligrams (mg)~     versus placebo in subjects with inoperable CTEPH. The study will enrol 160 subjects, to~     assure at least 72 evaluable subjects per treatment arm, based on 10% drop-out rate.~   "
128560|NCT01884662|"~     Spinal cord injury neuropathic pain (SCI-NP) is a common problem, and when severe, is one of~     the most problematic of secondary conditions that is minimally to modestly responsive to~     currently available treatments. It is usually described as burning or stabbing, and is~     located at or below the level at which their sensation changes from normal to impaired;~     persons with no feeling at all in their legs for example can experience pain in the legs. The~     purpose of this project is to further investigate the use of a novel visual stimulation~     treatment; a technique that has shown benefit in other populations with chronic pain~     secondary to deafferentation. To accomplish this, a novel treatment - virtual reality (VR)~     walking - will be examined. Should this treatment show benefit, a portable, accessible means~     of treatment will be available for persons with SCI and for whom transportation to health~     care providers is often difficult.~   "
128561|NCT01884649|"~     Fetuin-A levels are reported to be low as a negative acute phase reactant in systemical~     inflammatory situations. Hashimoto thyroiditis is characterized with inflammation. In this~     study, we hypothesised that the serum fetuin A levels could be found to be low due to~     inflammation in patients with Hashimoto thyroiditis~   "
128562|NCT01884636|"~     The purpose of this study is to assess the effect of multiple doses of isavuconazole on the~     pharmacokinetics of a single dose of methotrexate. Safety and tolerability of isavuconazole~     will be assessed alone and in combination with methotrexate.~   "
128563|NCT01884623|"~     To test whether cetuximab improves efficacy/tolerance as compared to methotrexate in first~     line treatment of unfit patients ³ 70 years old with recurrent and /or metastatic HNSCC.~     Efficacy assessed by failure free survival~   "
128564|NCT01884610|"~     Granulocyte Colony Stimulating Factor (GCSF) is used extensively as a means of mobilising~     donor peripheral blood stem cells as an alternative to bone marrow harvesting for the purpose~     of recipient stem cell transplantation. The principal objective of the research is to study~     any longterm genetic effects of GCSF in the peripheral blood white cells of unrelated blood~     stem cell donors.~      The study subjects will be Retrospective and Prospective voluntary unrelated donors on the~     Anthony Nolan Bone Marrow Registry being harvested at the Royal Free Hospital and University~     College Hospital, London and British Bone Marrow Registry donors harvested at the Royal Free~     Hospital and BUPA Glen Vale in Bristol.~      All participants in the Prospective Arm will be asked to donate one 5−10ml sample of blood at~     study entry prior to stem cell donation and further samples at 120 and 360 days post~     donation. Those found to carry aneuploid cell clones at these time points will be asked for a~     further 5−10ml blood sample at least twice − at the end of 24 months and 36 months~     respectively. The Retrospective and Positive Control group will be asked to supply one 5−10ml~     sample of blood.~   "
128565|NCT01884597|"~     This is a 24-month study of ranibizumab (2.0 mg and 1.0 mg) in subjects with polypoidal~     choroidal vasculopathy as diagnosed by fluorescein/indocyanine green (FA/ICG) angiography.~   "
128653|NCT01883440|"~     Glucose oxidase is a hydrogen peroxide producing enzyme, which also is present in honey.~     Human rhinoviruses are sensitive to the action of hydrogen peroxide, which is documented in~     laboratory studies.~      In the present study we aim to investigate if a nasal spray with glucose oxidase could treat~     a common cold, when the treatment is started even after the onset of the symptoms. The study~     is randomized and placebo controlled.~   "
128566|NCT01884584|"~     The surgeon may remove a very small amount of additional tissue compared to what would be~     removed if you were not enrolled in the study. This tissue may prove to contain tumor or it~     may contain normal tissue. The surgical cavity will be examined by a special laser pen after~     the tumor is removed, and if areas of fluorescence are seen, that may indicate tumor cells~     where the ICG dye collected are still remaining and the surgeon would then remove those.~     After the tumor and the tissue around it are removed and sent to the laboratory, the tissue~     may be examined using that same laser pen to see where the cancer cells are and compare that~     to what the laboratory sees when it looks at the tumor and tissue with a microscope. It is~     hoped that what the dye shows and what is seen with the microscope will be alike.~   "
128567|NCT01884571|"~     This is a multicenter, 15-month study evaluating the effect of immunosuppression treatment on~     the rate of change on the ALS Functional Rating Scale (Revised) (ALSFRS-R) score in up to 33~     subjects with Amyotrophic Lateral Sclerosis (ALS).~   "
128568|NCT01884558|"~     The purpose of this study is to assess the effect of multiple doses of isavuconazole on the~     pharmacokinetics of a single dose of metformin. Safety and tolerability of isavuconazole will~     be assessed alone and in combination with metformin.~   "
128569|NCT01884545|"~     The purpose of this study is to examine whether the use of genetic test information and/or~     health coaching in patient risk counseling for heart disease and diabetes affect health~     behaviors and health outcomes in active-duty Air Force (ADAF), beneficiaries or dependents~     and Air Force retiree patients.~      Total of 400 subjects will be enrolled. They will be randomly(like flipping a coin)assigned~     to 4 groups: 1)Standard risk assessment (SRA)only; 2)SRA plus genetic risk information~     (SRA+G); 3)SRA plus health coaching (SRA+HC); or 4)SRA, genetic risk information, and health~     coaching (SRA+G+HC). Subjects randomized to the two genetic arms will have blood collected~     for testing of investigational coronary heart disease (CHD) and type 2 diabetes (T2D) risk~     markers. Participants in the two groups that include health coaching will be assigned to a~     trained certified health coach for a period of 6 months. The duration of the study is 12~     months with 3 in person visits (baseline, 6 months and 12 months) and completion of surveys~     at 6 weeks and 3 month time points.~   "
128570|NCT01884532|"~     The purpose of this clinical study is to evaluate blood metal ion levels as a function of~     time of implantation for the ASR-XL MoM system.~   "
128571|NCT01884519|"~     The purpose of this study is to assess, in adults 18 years of age and above, the~     immunogenicity and reactogenicity of the seasonal influenza vaccine, Fluarix/Influsplit SSW~     2013/2014, containing the three vaccine influenza strains (two A strains and one B strain)~     for the 2013/2014 season.~   "
128572|NCT01884506|"~     A total of 75 subjects will be recruited for this study (25 normal weight, 25 overweight, 25~     obese). In each subject blood volume will be determined using the minimally invasive carbon~     monoxide-rebreathing method (substudy 1) and iron absorption will be measured from a test~     meal labeled with stable iron isotopes. The effect of ascorbic acid on iron absorption will~     further be determined using a second labeled test meal (substudy 2). In addition,~     inflammation, hepcidin and iron status will be determined. In order to study the effect of~     body fat content on blood volume and iron absorption weight and height will be measured, and~     body fat will de determined by dual energy X-ray absorptiometry.~   "
128573|NCT01884493|"~     The gait symptoms are usually refractory to the dopaminergic agents and some other~     resolutions, i.e. repetitive transcranial magnetic stimulation (rTMS) should be searched for~     in this regard. To study the impact of rTMS, investigators will adopt a domestically~     developed ambulatory recorder (PK-16CH EXG) for the concomitant recording of the~     electroencephalographic and electromyographic signals for PD patients when walking in the~     gait laboratory or when conducting leg dorsiflexion movement on sitting.~   "
128574|NCT01884480|"~     In Kidney transplant recipients Once daily Tacrolimus has the poteb]ntial advantage of better~     adnerence, and perhpas improvement in reanl function compred with the twice daily tacrolimus~     formulation.~      Our center has the largest experience in North America with once-daily tacrolimus ( advagraf)~     in Renal transplant recipients.~      Recently we converted ~500 stable patients from the twice daily to once-daily tacrolimus.~      We are interested in:~        1. change in renal function~        2. dose changes based on ethnic diveristy~        3. dose changes based on pharmacogenetics~      This will helpnus understand better ways to utilize this anti-rejection medication~   "
128575|NCT01884467|"~     Recurrent UTIs are common among patients on IC. These create significant patient morbidity~     and healthcare burden. In desperation, many physicians prescribe prophylactic oral or~     intravesical antibiotics. This practice is common among our Gillette clinic patients.~     However, the benefit is unclear and the risks are not insignificant. As such, practice~     variation is significant. In order to better define the evidence for or against gentamicin~     bladder irrigation and thus inform clinical practice both locally at our Gillette urology~     clinic and for practitioners at large we will pursue the following specific aims:~        1. Compare rates of symptomatic urinary tract infection and asymptomatic bacteriuria among~          a population of Gillette patients on IC with and without gentamicin bladder~          instillation.~        2. Compare antibiotic resistance rates among a population of Gillette patients on IC with~          and without gentamicin bladder instillation.~   "
128576|NCT01884454|"~     In view of the hormonal changes induced by both sleep deprivation and obstructive sleep apnea~     syndrome (OSA), and the importance of maintaining these hormones in reproductive processes.~     The present study aims to evaluate the effects of the OSA or sleep deprivation (total or~     selective REM sleep for 48h) on reproductive function in adult men with normal body mass~     index.~   "
128577|NCT01884441|"~     Test of bendamustine in combination with gemcitabine and vinorelbine could contribute to a~     higher response rate with the reduction of toxic side effects~   "
128578|NCT01884428|"~     study to assess maximum tolerated dose (MTD), safety, tolerability and activity of IGEV~     (Ifosfamide, Gemcitabine,Vinorelbine, Prednisolone) + Panobinostat new combination in order~     to determine the recommended phase II dose~   "
128579|NCT01884415|"~     The objective of this clinical trial is to compare the response rate obtained with two~     different vaccination schemes against HBV in cirrhotic patients. These patients must be~     candidates for liver transplantation, who have failed seroconversion (anti-HBs < 10 IU/ml)~     after three intramuscular doses of 40 µg.~   "
128580|NCT01884402|"~     Primary objective:~      • Develop and validate a tool towards patients with chronic hepatitis C genotype 1 and 4 to~     allow optimize treatment.~   "
128581|NCT01884389|"~     This study is testing a navigation program for early palliative care provided in tandem with~     HIV primary care for persons living with HIV (PLWH) who are at high risk or mortality and~     morbidity related to their co-morbid chronic conditions. Participants are enrolled for a~     period of 36 months, with data collection at enrollment and every 9 months after, for a total~     of 5 data collection time points. Study participants enrolled will be randomized into one of~     two groups: control or intervention. Control group participants will receive control calls in~     between survey data collection time points. Intervention group participants will participate~     in a Navigation Program which includes home visits and phone calls with an advanced practice~     nurse (APN) and licensed social worker (LSW), as well as visits / calls by a volunteer if~     desired. The frequency of visits / calls will be determined based on level of need (high,~     medium or low).~      The specific aims of the study are to: 1) identify needs and preferences for palliative care~     and advance care planning for PLWH, in order to tailor an existing Navigation Program for~     this study; 2) test the effectiveness of an HIV Navigation Program intervention on outcomes~     of quality of life, symptom burden, coping ability, and advance care planning; and 3)~     determine if effectiveness of the HIV Navigation Program intervention differs by age, gender,~     ethnicity, education, income level, and level of palliative care service need.~   "
128582|NCT01884376|"~     The aim of this study is the development and initial clinical application of the nerve guide~     Neuromaix in humans to provide evidence for the safety and performance of the device.~      Neuromaix is intended to be used as a guiding structure to bridge a peripheral nerve~     discontinuity, and to create a conduit for axonal growth across the nerve gap.~   "
128583|NCT01884363|"~     This study will examine whether a twelve-week intervention with one ounce (28 g) per day of~     walnuts improves endothelial function measured non-invasively using finger probe~     (EndoPat-2000) in people with coronary heart disease or type 2 diabetes.~   "
128584|NCT01884350|"~     The study purpose is to assess the impact of an educational program on patient adherence in~     patients taking Apixaban for SPAF at 24 weeks~   "
128585|NCT01884337|"~     The primary purpose of this protocol is to evaluate the safety of Apixaban in prophylaxis of~     Venous Thromboembolism (VTE) in Indian patients undergoing elective total knee or hip~     replacement~   "
128586|NCT01884324|"~     Primary objective: to test the hypothesis that elective early delivery will protect the fetal~     bowel from the deleterious intrauterine factors late in the pregnancy and will be associated~     with improved neonatal outcomes.~      Secondary objective: to introduce a standardized diagnostic, monitoring, and postnatal~     surgical management of infants with gastroschisis.~   "
128587|NCT01884311|"~     The main objective of the study is to determine the pharmacokinetics profile of Subgam-VF.~     The secondary objectives are to assess the safety of Subgam-VF and refine the dose adjustment~     coefficient for Subgam-VF needed for subjects switching from prior intravenous immunoglobulin~     (IGIV) therapy.~   "
128588|NCT01884298|"~     In General anesthesia, two main ways of pain control are used intra-operatively, one is~     opioids, the other is epidural. Many colleges prefer using epidural analgesia because it is~     potent and more effective , and also the benefits of stress block, less depression of breath.~     however, the epidural technique often causes more drop of blood pressure, especially in~     dehydrated patients. The investigators designed the trial to see if the benefit weigh out the~     potential risk of epidural in isolated hypertensive patients.~   "
128589|NCT01884285|"~     This is a phase I, open-label, multicentre study of AZD8186 administered orally in patients~     with advanced castrate-resistant prostate cancer (CRPC), squamous non-small cell lung cancer~     (sqNSCLC), triple negative breast cancer (TNBC) and known PTEN-deficient/mutated or PIK3CB~     mutated/amplified advanced solid malignancies as monotherapy and in combination with~     abiraterone acetate or AZD2014.~   "
128590|NCT01884272|"~     This is a drug-drug interaction study in healthy volunteers to evaluate the potential~     pharmacokinetic (PK) effects of non-steroidal anti-inflammatory drugs on lesinurad and~     leinurad on the non-steroidal anti-inflammatory drugs.~   "
128591|NCT01884259|"~     This multicentre, randomised Phase II Pilot Study evaluates the efficacy of docetaxel,~     cisplatin and 5-fluorouracil or Cetuximab, followed by Cetuximab with radiotherapy.~   "
128592|NCT01884246|"~     Individuals in Appalachian Kentucky are vulnerable to cardiovascular disease (CVD) by virtue~     of having high rates of multiple CVD risk factors. There is a critical need to develop and~     test CVD risk reducing interventions that are appropriate and effective in Appalachia. In the~     absence of such interventions, the dramatic CVD disparities seen in this area will continue~     to rise.~      Lifestyle interventions reduce CVD risk by 44%. The investigators and others have~     demonstrated that lifestyle change is most effective when patients are given the tools to~     engage in effective self-care, and that interventions individualized to patients' specific~     needs and barriers are more effective than interventions that are not. The central hypothesis~     is that to be successful in Appalachia, CVD risk reducing interventions must focus on~     patient-centered lifestyle change that increase individuals' abilities to engage in~     self-care, must be culturally appropriate, and must have components that overcome barriers~     faced by individuals living in Appalachia.~      The investigators propose a randomized, controlled comparative effectiveness trial with 300~     individuals from Appalachian Kentucky who do not have a primary care provider and who are at~     risk for CVD by virtue of having two or more modifiable CVD risk factors. The investigators~     will compare (1) a patient-centered, culturally appropriate, self-care CVD risk reduction~     intervention (HeartHealth) designed to improve multiple CVD risk factors while overcoming~     barriers to success with (2) referral of patients to a primary care provider for management~     of their CVD risk factors. The investigators propose the following specific aims to be tested~     at 4 months and 1 year after baseline. To compare the short and long-term impact of the~     interventions on:~      1) the risk factor selected by patients (i.e., tobacco use, blood pressure, lipid profile,~     hemoglobin-A1c (HgA1c) for diabetics, body mass index, waist circumference, depressive~     symptoms, or physical activity level); 2) all of the CVD risk factors of each patient; 3)~     quality of life; 4) patient and healthcare provider satisfaction; 5) desirability and~     adoptability by assessing adherence to recommended CVD risk reduction measures, and retention~     of recruited individuals. The investigators hypothesize that in comparison to the referral~     strategy, the multifaceted patient-centered, self-care intervention will engender more~     favorable outcomes across all measures.~   "
128593|NCT01884233|"~     The objective of the current research is to improve treatment for injection opioid users by~     augmenting pharmacotherapy with an innovative text-messaging strategy to promote relapse~     prevention skills, reduce HIV-risk behaviors, and improve HIV treatment regimen adherence.~   "
128594|NCT01884220|"~     The purpose of this study are: to characterize and understand the natural history of disease~     progression in WD and CESD, and to provide historical controls for WD and CESD for developing~     clinical treatment trials. The hypothesis is that the variability and clinical progression in~     WD and CESD is large and represents a continuum of severities from a lethal infantile to near~     normal adults with only fatty livers.~   "
128654|NCT01883427|"~     To investigate if use of glucosoxidas nasal spray can reduce the number of days with upper~     respiratory tract infections in children beyond 4 years.~   "
128595|NCT01884207|"~     Prospective study on patients with orbital tumors of unknown origin. Aim of the study is to~     differentiate benign from malignant tumors upon MR imaging. Magnetic resonance imaging of the~     orbit will be performed including standard morphological sequences and advanced sequence~     techniques. These advanced sequence techniques may allow to differentiate benign from~     malignant tumors based on their cellularity and vascularity (diffusion and perfusion~     imaging). These MRI data will be analysed and the level of diffusion and perfusion will be~     measured and compared to the histological findings. Cut-off values of diffusion and perfusion~     will be calculated that allow to separate benign from malignant tumors.~   "
128596|NCT01884194|"~     MRI is useful for diagnosing pinealoblastoma in retinoblastoma patients~   "
128597|NCT01884181|"~     The hypotheses of the project are~        1. Diffusion MRI using compressed sensing could have reduced motion sensitivity and~          improved susceptibility related artifact because of accelerated acquisition.~        2. The macromolecule deposition in the brain of patients with Huntington Disease (HD) can~          lead to changes detectible by diffusion MRI.~      To validate the hypothesis that the new accelerated diffusion MRI technique could produce a~     new biomarker for HD, patients with Huntington Disease will be recruited. The diffusion index~     will be calculated using accelerated acquisition. The diagnostic performance will be~     evaluated for data reconstructed with and without acceleration. The correlation with the~     disease severity will be assessed.~   "
128598|NCT01884168|"~     To investigate gene expression profile and immunological associated analysis relating to~     immunotherapy response of patients with malignant tumor presenting malignant cavity effusion~     after DC-CIK immunotherapy.~   "
128599|NCT01884155|"~     This open label trial is conducted to investigate the efficacy and safety of allogeneic~     umbilical cord blood (UCB) therapy for patients with stroke.~   "
128600|NCT01884142|"~     The investigators hypothesize that exercise training would improve the mechanoreflex and~     metaboreflex control in heart failure patients.~   "
128601|NCT01884129|"~     We hypothesized that the number of circulating tumor cells (CTCs) and molecular markers on~     CTCs could be a prognostic factor or predictive factor to patients with head neck cancer.~   "
128602|NCT01884116|"~     Myofascial pain syndrome (MPS) is a common clinical problem of musculoskeletal pain and~     various treatment modalities have been introduced. If self-applicable physical modalities and~     medications that are used for treatment of MPS patients are combined, they may open up new~     possibilities for effective and practical self-care. The aim of this study is to compared the~     therapeutic effect of non-steroidal anti-inflammatory drug (NSAID) patch given in monotherapy~     and NSAID patch in combination with transcutaneous electric nerve stimulation, heating pad,~     or topical capsaicin in the treatment of patients with MPS of the upper trapezius.~   "
128603|NCT01884103|"~     Our overall goal in this proposed study is to describe the current prehospital trauma triage~     process for older adult (age≥55) patients with suspected Traumatic Brain Injury (TBI), to~     identify the effect of certain medications (anticoagulants and platelet inhibitors) on~     TBI-related need for trauma center services, and to identify novel TBI screening strategies~     that are feasible for use in the prehospital setting.~   "
128604|NCT01884090|"~     The Youth Empowerment Solutions for Positive Youth Development (YES) Study , is a randomized~     controlled trial that compares youth in standard after school programs offering activity~     choice (e.g. sports, academic enrichment, arts) to youth assigned to an after school program~     that includes training in community development, formation of intergenerational partnerships~     and experience conducting community improvement projects. The study aims are to: 1) implement~     and evaluate an empirically developed intervention for empowering youth (YES) using a~     randomized controlled trial design in a high risk urban and suburban sample; 2) test a~     conceptual model that posits a causal relationship from youth empowerment processes to~     positive developmental outcomes; and 3) follow youth over time to assess sustainability of~     gains in healthy development. Developmental outcomes will be assessed at baseline, curriculum~     completion and at three and nine months post-intervention.~      This study will be referred to as the Genesee County Afterschool Study (GCAS) in recruitment,~     consents, assents and promotional materials. The study compares different types of after~     school programs, and we will be randomly assigning students into two groups, 1) the regular~     21st Century Afterschool programs and 2) the regular 21st Century Afterschool programs with~     the YES supplement. We do not want to bias desirability of the random groups by naming one of~     the groups to be tested in the study name. Therefore, in documents we will refer to the study~     as the Genesee County Afterschool Study (GCAS).~      Study hypotheses:~        1. Youth in the YES intervention arm will demonstrate increased intrapersonal,~          interactional, and behavioral empowerment than youth in the comparison group arm.~        2. Youth in the YES intervention arm will demonstrate higher scores on the positive~          developmental outcome variables, and lower scores on the negative developmental outcome~          variables, than youth in the comparison group arm.~        3. Behavioral empowerment will partially mediate the relations between intrapersonal and~          interactional empowerment and youth developmental outcomes, such that youth with greater~          intrapersonal and interactional empowerment skills will demonstrate increased behavioral~          empowerment, which in turn will result in higher scores on positive developmental~          outcome variables, and lower scores on negative developmental outcome variables.~   "
128605|NCT01884077|"~     Specific Aim: To compare early postoperative pain relief in patients over the age of 70 who~     undergo either Total Shoulder Arthroplasty or Reverse Shoulder Arthroplasty in treatment of~     glenohumeral osteoarthritis.~      Hypothesis: Early postoperative pain relief will be greater in those undergoing Reverse~     Shoulder Arthroplasty.~   "
128606|NCT01884064|"~     This study investigated the short term effects of repeated administrations of~     repetitive-transcranial magnetic stimulation (rTMS) on clinical changes and investigate~     neurophysiologic responses to rTMS of the activated motor system in patients with FHD.~   "
128607|NCT01884051|"~     Our hypothesis is that optimal treatment of the dysfunctional metabolic pathways which~     underlie PAH will improve pulmonary vascular function and consequences of the disease.~   "
128608|NCT01884038|"~     Patients undergoing orthotopic liver transplant will experience some degree of clinical~     and/or biochemical hepatic dysfunction. This early injury is known as primary graft~     dysfunction and varies from minor abnormalities to primary nonfunction. Prostaglandin-class~     drugs, including prostacyclin and its analogs, could represent an important advance toward~     the goal of reducing transplant related morbidity, mortality and associated costs by~     providing these benefits.~   "
128609|NCT01884025|"~     Individuals with serious mental illness have greater morbidity from physical illness and~     mortality than the general population, but tend not to initiate or sustain engagement in~     health promotion interventions. Although promising weight management and wellness~     interventions have been developed for this population, they are very intensive and tend to~     have low enrollment, high attrition, and low reach. This pilot study will investigate a novel~     low-demand intervention that may be initially more acceptable, the Get Moving and Get Well!~     (GMGW) program. The primary objectives of the proposed study are to investigate the effects~     of participation in the GMGW program on measures of behavioral activation, self-efficacy,~     physical activity, general physical and mental health, mood, participants' intent to engage~     in more intensive physical health interventions, and actual engagement in those programs.~     Results of this pilot study will inform a future full-scale study of GMGW.~   "
128613|NCT01883973|"~     Most leading academic centers including Baylor College of Medicine (BCM) perform deep brain~     stimulation surgery in the awake patient using microelectrode recording to guide final~     electrode placement. Microelectrode recording is a means of analyzing the electrical activity~     of the brain, and assessing whether we have found the target for the deep brain stimulator~     electrode. However, no evidence exists that microelectrode recording improves patient~     outcomes. The use of microelectrode recording does extend the duration of surgery and there~     is evidence to suggest that microelectrode recording may increase the risk of bleeding in the~     brain during surgery.~   "
128614|NCT01883960|"~     The primary goal of this study is to establish and evaluate an image-based biomarker for the~     impaired motor control and sensory information processing present in Cerebral palsy (CP) and~     stroke patients.~   "
128615|NCT01883947|"~     The aim is to study effects of touch massage in the sub-acute phase after stroke in two main~     areas; general health and independence.The hypothesis are that; touch massage in the~     sub-acute phase after stroke decreases anxiety and pain, increases health related-quality of~     life, decrease physiological stress responses, increase sensorimotor function, decrease~     disability, and increase activity in sensorimotor areas and decrease redundant brain activity~     in motor-related areas.~   "
128616|NCT01883934|"~     The purpose of this study is to improve patient understanding of and interest in donating~     frozen embryos resulting from in vitro fertilization (IVF) to others undergoing infertility~     treatment.~   "
128617|NCT01883921|"~     Primary:~        -  Demonstrate the utility of an electronic data capture (EDC) system (CareExchange™) using~          infusion nurse and patient measured physical, quality of life (QOL), respiratory,~          laboratory, and disability assessments in patients with Primary Immunodeficiency Disease~          (PIDD).~      Secondary:~        -  Change in Intravenous/Subcutaneous Immunoglobulin (IVIg/SCIg) dose effects measured~          outcomes.~        -  Change in IVIg/SCIg dose timing effects measured outcomes.~        -  Change in patient status is reflected in measured outcomes.~        -  Assess the value to physicians from collected outcomes data.~        -  Identify types of patients by response to IVIg/SCIg therapies (well maintained,~          problematic, etc.).~        -  Change in response rate as measured by outcomes to IVIg/SCIg therapies by disease state,~          co-morbidities, and demographics.~   "
128618|NCT01883908|"~     Patients are asked to be in this study if have oropharyngeal cancer and will be treated with~     chemotherapy and radiation.~      This research is being done to find out if acupuncture can reduce the mouth inflammation and~     pain caused by chemotherapy and radiation. Chemoradiation may cause mouth inflammation and~     pain.~      Acupuncture is a medical technique of inserting very thin needles into the energy points on~     the body with the aim to restore health and well-being. It has been used widely to treat~     pain, such as lower back pain and joint pain. In this study we will assess the potential~     usefulness of acupuncture to decrease the severity of mucositis and mucositis-related mouth~     and throat pain in patients receiving chemoradiation for oropharyngeal cancer.~      Mouth cancer patients receiving chemoradiation who have not had acupuncture within the last~     one month and who do not have a history of head and neck cancer may join this pilot study.~   "
128619|NCT01883895|"~     The study involves recording response to discomfort following different forms of exercise. We~     think that there will be a increased pain tolerance following exercise but are unsure if~     there will be a difference between exercises.~   "
128620|NCT01883882|"~     The proposed research will develop, demonstrate the feasibility of, and pilot test in a~     randomized controlled trial a prescription opioid taper support intervention. This~     intervention aims to prevent opioid misuse and adverse events among patients receiving~     chronic opioid therapy for chronic non-cancer pain without evidence of current substance~     abuse.~      The project will yield information essential to planning a future, larger-scale RCT designed~     to evaluate: 1) the efficacy of the intervention in preventing prescription opioid abuse,~     misuse, overdose and other adverse events among patients receiving chronic opioid therapy for~     chronic non-cancer pain, 2) the effects of the intervention on opioid use, pain, pain related~     activity interference, and mood. Participants in our pilot study will be limited to those~     without current opioid abuse or other substance abuse, but past substance abuse will be~     allowed. This will provide a sample of patients at risk for opioid abuse, misuse and~     overdose, but who may be able to taper their opioids successfully. Hypothesis: Patients~     receiving chronic opioid therapy for chronic non-cancer pain who are randomized to the opioid~     taper support intervention, as compared with patients randomized to usual opioid prescribing~     care, will have lower opioid average daily doses at 22 and 34 weeks.~   "
128621|NCT01883869|"~     The hypothesis to be tested is that ticagrelor (Brilinta™) will reduce platelet activation~     and markers of inflammation in patients with pneumonia.~   "
128622|NCT01883856|"~     The purpose of this study is to evaluate and compare the clinical outcomes after implantation~     of the porous plate (polyethylene) (Model M4) Ahmed Glaucoma Valve with the silicone plate~     Ahmed Glaucoma Valve (Model FP7) in participants with refractory glaucoma.~   "
128623|NCT01883843|"~     Stroke is one of the major causes of disability in the Western world. Initially gait is the~     most affected function, 80% of patients lose this ability.~      Rehabilitation in stroke patients improves walking abilities in terms of gait and related~     gait activities, though six months after stroke many patients are significantly disabled.~      Recently, a prospective study of 205 stroke patients showed that approximately 21% of~     patients have a significant decrease of mobility between the first and the third year after~     stroke. The main finding showed that inactivity was the most important factor for the~     mobility decline.~      Evidence about effects of direct current brain stimulation on motor recovery function of~     lower limb are still little, some show that quadriceps strength after stimulation of damaged~     M1 area increased. Another study where tDCS was associated with robotic gait training did not~     report any effect compared to treatment alone. It is necessary to define if a different~     dosage of stimulation or the association of tDCS with gait training can improve walking and~     if further studies are required to investigate their effectiveness.~      The aim of this clinical trial is to test the possibility of gait improvement through the~     association of tDCS with a specific task-oriented circuit training for walking abilities,~     balance and mobility.~   "
132886|NCT01827930|"~     The Imatinib Mesylate at a dose of 400 mg / day is the standard treatment for patients with~     CML-CP. Recent studies show that the quality of response rate (complete cytogenetic response~     and major molecular response rate) is dependent on the residual plasma Imatinib.~   "
128624|NCT01883830|"~     Traumatic brain injury is an extremely common disease, it counts 50.000 deaths and 235.000~     hospitalizations every year. Functional consequences of an acquired brain injury have a~     considerable impact on quality of lives of patients and care-givers with direct effects on~     balance, mobility and on psycho-social functions. Attention deficits are one of the most~     frequent and disabling consequences of severe brain injury. Within the wide spectrum of~     attentive problems, patients with traumatic brain injury frequently have shown difficulties~     in divided attention. Patients, care-givers and professionals frequently refer difficulties~     also in selective attention and vigilance as consequence of the trauma. It has been shown how~     these difficulties are tightly related with the missed return to work after two years from~     the injury.~      The hypothesis of this study is to investigate the feasibility of a rehabilitative protocol~     on gaming using the console Xbox and its efficacy in improving balance, mobility, risk of~     falling, attentive functions (selective and divided attention) in subjects which have had a~     traumatic brain injury at least 12 months before.~   "
128625|NCT01883817|"~     The study hypothesis is that DHA is more effective than placebo in increasing brain~     activation and reducing symptoms in psychostimulant-free children with ADHD.~   "
128626|NCT01883804|"~     Type 1 Diabetes is an autoimmune condition in which segments of the immune system cause the~     destruction of insulin producing cells in the pancreas, leaving individuals with an impaired~     ability to control blood glucose levels. Currently there is no cure for Type 1 Diabetes and~     the treatments involve lifelong insulin administration and careful monitoring of blood~     glucose levels. Long-term complications like cardiovascular disease, nerve damage, and retina~     damage, may result. Previous studies have shown that improvement in the control of blood~     glucose can reduce the risks from these long-term complications. Residual insulin production,~     typically within the first few years following diagnosis, helps to reduce an individual's~     need to supplement insulin by injection or pump. This effect helps in maintaining the body's~     ability to regulate blood glucose levels and reducing the needs of external insulin.~      Methyldopa, or Aldomet, has been approved by the Food and Drug Administration and is commonly~     used to treat high blood pressure. This drug has been approved for several decades and has~     been shown to be safe and effective. This drug has been identified by the researcher to be~     able to block the communication between two important types of immune cells; which play a~     critical role in the autoimmune processes of Type 1 Diabetes. The investigators hypothesize~     that Methyldopa, over a 6 week treatment period, will block this communication and possibly~     slow down the destruction of insulin producing cells. The investigators hope to assess the~     appropriate and safe dose to achieve this effect, along with the drug's ability to maintain~     insulin production and blood glucose control.~   "
128627|NCT01883791|"~     An estimated 40% of patients in mental health treatment settings engage in hazardous alcohol~     and/or drug use. One model of intervention that has been shown effective in medical settings~     to reduce alcohol use and/or promote engagement in addiction treatment is screening, brief~     intervention, and referral to treatment (SBIRT). Despite the effectiveness of SBIRT for risky~     alcohol use in medical settings, there has been no research on the effectiveness of SBIRT in~     mental health treatment settings. Given the proportionately large number of mental health~     patients who also engage in hazardous substance use, research is needed to find an~     appropriate and effective substance use intervention for patients in these settings.~      The proposed study uses a randomized controlled trial to examine the extent to which the~     World Health Organization's SBIRT model, the ASSIST (Alcohol, Smoking, and Substance~     Involvement Screening Test) and its associated brief behavioral intervention, leads to~     reductions in substances prevalent in mental health settings: alcohol, cannabis and~     stimulants (i.e., cocaine and methamphetamine). The study will also examine the effect of~     SBIRT on improvement in psychiatric symptoms, improved quality of life and for those whose~     level of substance misuse indicates a need for treatment, initiation and engagement into SUD~     treatment services. Eligible participants will be mental health patients who report any past~     year use of cannabis or stimulants or at least one heavy drinking day in the past year.~     Mental health patients (N=750) who meet eligibility criteria will be enrolled and randomly~     assigned to either the SBIRT intervention condition or to a health education attention~     control condition. Participants will be assessed at baseline on substance use, psychiatric~     symptoms and quality of life. Each participant will be assessed at 3-, 6- and 12- month~     follow up points for alcohol and drug use, involvement in SUD treatment services, severity of~     psychiatric symptoms and quality of life. If successful this study will yield valuable new~     knowledge about the effectiveness of SBIRT in mental health treatment settings and will~     promote improved well being of mental health patients. Further, the study will provide~     evidence on the effectiveness of SBIRT for reducing illicit drug use. Results from this~     research will be used as the basis for broader dissemination and of SBIRT in mental health~     settings.~   "
128628|NCT01883778|"~     The purpose of this study is to identify existing cost knowledge of Emergency Medicine (EM)~     physicians and patients and investigates its reported impacts on medical compliance. A~     cross-sectional survey will be administered electronically to Emergency Medicine physicians~     at the University of Utah Hospital and the Emergency Physician Integrated Care, LLC (EPIC)~     who staff ten-community hospital Emergency Departments (ED) in order to investigate physician~     knowledge and attitudes regarding cost and perceived patient compliance. In addition, a~     cross-sectional survey will be administered to a convenience sample of patients presenting to~     the University of Utah Emergency Department to obtain information about their cost knowledge~     and reported compliance. All ED patients will complete a follow-up phone survey to measure~     compliance with recommendations made during the ED visits. Following administration of the~     baseline survey physicians will be provided the prices of the test and procedures and will be~     re-surveyed 30-days later as a post intervention test to measure changes in knowledge and~     attitudes.~   "
128629|NCT01883765|"~     Neurofeedback training (NFT) has been frequently investigated as an alternative treatment for~     ADHD mainly in children and adolescents. However, randomized double-blind trials that include~     a sham-neurofeedback control group are lacking, as well as studies examining the efficacy of~     NFT in adult ADHD populations. The inclusion of a sham-neurofeedback group is crucial to~     monitor and exclude unspecific effects.~      This study aims to investigate the efficacy of NFT as compared to a sham-feedback condition~     and a cognitive behavioral treatment in adults with persistent ADHD.~      Efficacy is assessed on several outcome parameters, such as symptom severity,~     neuropsychological variables (e.g., attention, memory), and EEG parameters.~   "
128630|NCT01883752|"~     The purpose of this study is to evaluate whether goal directed fluid management using~     respiratory variations in the oxygen saturation by pulse oximetry (SpO2) waveform has~     potential to decrease postoperative complications and outcomes.~   "
128655|NCT01883414|"~     Up to 25 subjects will be enrolled. Enrolled subjects will received on Ulthera® treatment on~     one half of their surgical scar. Follow up visits will occur at 30, 90 and 180 days after~     treatment. Study images will be obtained before treatment, immediately after treatment and at~     each follow-up visit.~   "
128738|NCT01882335|"~     The study will estimate the effect of peer-counseling for exclusive breast feeding (EBF) in~     the first 6 months of life on cognition and other determinants of human capital formation~     including behavioral and emotional status; school readiness and attainment; health status;~     fine and gross motor skills; physical growth; and household economic status.~   "
128631|NCT01883739|"~     The investigators shall conduct a randomized controlled trial to investigate the effect of~     parental presence at transfer rounds on parental anxiety and patient safety following~     transfer from the Pediatric Cardiac Intensive Care Unit (PCICU) to the ward. The~     investigators plan to test the hypothesis that parental involvement in the child's transfer,~     with the option of peer support, will result in measurable reductions in medication errors,~     unplanned nutritional and feeding management, and parental anxiety after transfer as compared~     to the control group. The investigators goal is to improve continuity of care by implementing~     multidisciplinary transfer rounds at the child's bedside in which patients and family share~     in the control of the management plan when a cardiac child is discharged from PCICU to the~     ward.~   "
128632|NCT01883726|"~     Two types of Presurgical Nasoalveolar Molding (NAM) coexist in Craniofacial Center in Chang~     Gung Memorial Hospital. The objective of this study is to compare the number of clinical~     visits, total prices, complications and nasal symmetry between these two NAM reconstruction~     methods.~   "
128633|NCT01883713|"~     Acute and chronic anemia continue to be associated with increased mortality in a number of~     clinical settings, including cardiac and non-cardiac surgery. However, We have no clinical~     measures that let us know of impending insufficient oxygenation as anemia progresses (R.B.~     Weiskopf). The current proposal is based on experimental and clinical data which suggest that~     plasma methemoglobin (MetHb) may be a sensitive biomarker of tissue hypoxia and anemic~     stress in surgical patients.~      Hypothesis: Increased methemoglobin is a biomarker of tissue hypoxia during acute anemia.~      Primary Objective: To demonstrate a direct relationship between decreased Hb and increased~     MetHb in patients undergoing acute hemodilution on cardiopulmonary bypass (CPB).~   "
128634|NCT01883700|"~     This study examines the effects of carbohydrate type (high- or low-Glycemic Index (GI)) and~     amount (high- or low-Glycemic Load (GL)) have on blood glucose levels, blood pressure and~     arterial stiffness in healthy individuals. It will also determine whether subjective ratings~     such as test meal palatability and hunger are related to changes in blood glucose. The~     investigators hypothesize that: (1) High-GI meals, regardless of GL, will increase arterial~     stiffness; low-GI meals, regardless of GL, will have a neutral or lowering effect on arterial~     stiffness (augmentation index). (2) High-GI meals, regardless of GL, will have an elevating~     effect on both central and peripheral blood pressures. (3) The incremental area under the~     curve for blood glucose will show most significant differences between high-GI, high-GL and~     low-GI, low-GL meals at 30 and 90 min.~   "
128635|NCT01883687|"~     Objectives: The aims of this study are (1) to define the effectiveness of functional nasal~     surgery during Le Fort I osteotomy on nasal obstruction through objective as well as~     subjective evaluations, (2) to determine guideline for concomitant functional nasal surgery~     with Le Fort I osteotomy, and (3) to explore possible mechanisms by which functional nasal~     surgery may reduce nasal obstruction severity.~      Design: A prospective, single-blnd, randomized trial. Setting: Chang Gung Craniofacial Center~     and Department of Otolaryngology (ENT). Patients: A total of 80 Taiwanese patients with~     unilateral cleft lip and palate and dentofacial deformity (age >16 for females, >18 for~     males; 40 in experimental and 40 in control groups) Interventions: In the experimental group,~     all patients will receive Le Fort I osteotomy and septoplasty. In the control group, all~     patients will receive Le Fort I osteotomy only.~      Measurements: All patients will undergo history taking, clinical examination,~     radioallergosorbent (RAST) examination (before surgery), standard questionnaire and image~     examination before surgery, one week, 1, 3, 6, 12 and 24 months after surgery. To reduce~     radiation exposure, cone-beam CT will only be performed before surgery and one week, 12 and~     24 months after surgery.~      Data Analysis: Independent t and chi-squared tests, correlation coefficients and repeated~     measures analysis of variance (ANOVA) will be used. Statistical significance is assumed for a~     p value of less than 0.05.~      Key Words: cleft lip palate, nasal septum deviation, Le Fort I osteotomy, septoplasty,~     effectiveness~   "
128636|NCT01883674|"~     This project evaluates the use of different types of proteins from various food sources after~     an exercise session, on muscle mass and physical capacity in aged sarcopenic men (who have~     low muscle mass). Specifically, researchers want to:~        -  Examine the efficiency of protein intake after exercise on muscle mass and physical~          abilities;~        -  Examine the impact of exercise and proteins on blood lipids (LDL cholesterol, HDL~          cholesterol, total cholesterol and triglycerides);~        -  Examine the impact of exercise and proteins on liver enzymes;~        -  Examine the impact of exercise and proteins on a hormone that controls hunger;~        -  Evaluate the program's impact on the ability of the body to produce energy.~      All participants are exercising (resistance training) and ingest one of the 3 different~     sources of proteins, immediately after training:~        -  Milk proteins (from milk beverage)~        -  Essential amino acids (added to a soya beverage)~        -  No protein (rice beverage - control group)~      Our hypothesis is that proteins from milk will induce a gain in muscle mass and physical~     function equivalent to the essential amino acids (EAA). We anticipate that both milk proteins~     and EAA will be both superior to control group.~      This would represent an interesting finding since milk is more accessible, palatable and~     cheaper than essential amino acids commercial mix.~   "
128637|NCT01883661|"~     The aim of this study is to prove the BMMNC Therapy in Multiple sclerosis, and to control~     symptoms and help to maintain a normal quality of life of suffering patients.~   "
128638|NCT01883648|"~     This is a randomized, cross over study to determine the efficacy of coconut oil in subjects~     with mild to moderate Alzheimer's disease.~   "
128639|NCT01883635|"~     The purpose of the study is to see whether exercise can improve the health and well-being of~     cancer survivors. We also want to know about the health and well being of caregivers.~   "
128640|NCT01883622|"~     Continuous glucose monitoring (CGM) methods provide details of magnitude and duration of~     glucose fluctuations, giving a unique insight on daily blood sugar control. Limited data are~     available on glucose variability (GV) in pregnancy. The aim of this study was to assess GV in~     normal pregnant women and cases of type 1 diabetes mellitus or gestational diabetes (GDM),~     and its possible association with HbA1c.~   "
128676|NCT01883141|"~     The purpose of the iSPOT Study is to evaluate the contractility using positive left~     ventricular (LV) dP/dt max across LV pacing site(s) in patients indicated for cardiac~     resynchronization therapy (CRT).~   "
132887|NCT01827917|"~     The objective of this study was to achieve the post-marketing protective effect research of~     Speeda® rabies vaccine for human use from Chengda Bio.~   "
128641|NCT01883609|"~     This is a clinical trial in which healthy volunteers will be administered experimental~     malaria vaccines. One group of volunteers will receive vaccination with the leading malaria~     vaccine candidate, RTS,S/AS01. This vaccine schedule will consist of 3 doses of RTS,S/AS01~     with an interval of 4 weeks between doses (Doses given at 0,4 and 8 week timepoints). Another~     group will receive a vaccination schedule composed of the same dosage and timing regimen of~     RTS,S, but they will also receive vaccination with ChAd63 ME-TRAP, 2 weeks after the first~     RTS,S followed 8 weeks later by vaccination with MVA ME-TRAP (2 and 10 week timepoints).~      The study will assess the safety of the vaccinations, and the immune responses to~     vaccination. Immune responses are measured by tests on blood samples. Volunteers will be~     infected with malaria by mosquito bites, 12 weeks after the first vaccination. In addition, a~     group of volunteers not receiving vaccines will also be infected with malaria by the same~     method. These infection experiments will be used to assess vaccine efficacy: how well the~     vaccines act to prevent malaria disease. A further single volunteer may also be infected with~     malaria; this volunteer participated in a previous trial where they received vaccines and was~     completely protected against malaria disease after infection by mosquito bite.~      The RTS,S/AS01 vaccine is a protein (RTS,S) mixed with an adjuvant (AS01). The ChAd63 ME-TRAP~     and MVA ME-TRAP vaccines are called viral vectored vaccines. They are made from viruses which~     are modified so that they can not multiply. The viruses have extra DNA in them so that after~     injection, the body makes malaria proteins (but malaria does not develop), so that the immune~     system builds a response to malaria without having been infected by it.~      Healthy volunteers will be recruited in England at three research sites: in Oxford, London~     and Southampton.~   "
128642|NCT01883596|"~     To determine the efficacy of prophylaxis with 0.12% chlorhexidine gluconate compared with~     placebo to prevent ventilator associated pneumonia in children admitted to a pediatric~     critical care unit.~   "
128643|NCT01883583|"~     To check the possibility of the acquisition of a number of parameters through real-time~     contrast-enhanced ultrasound and sonoelastography images and to verify the correlation with~     pathologic results from ultrasound guided biopsy of transplanted kidney~   "
128644|NCT01883570|"~     Currently, teaching X-ray interpretation to medical students is not standardized, and is~     generally not very effective.~      Objective: The goal of our study is to evaluate whether directly teaching an expert search~     strategy for x-ray interpretation to 3d year medical students is effective.~      Methods:~        -  An expert's visual search strategy was recorded using a gaze-tracking device. The search~          strategy was then reproduced using a dynamic cursor moving across the corresponding~          chest x-ray, and incorporated into a teaching program accessible via the internet.~        -  Participants are 3rd year medical students who will be randomized into two groups. The~          experimental group will have access to the teaching program as described. The control~          group will have access to the same x-rays but not the expert's search strategy.~        -  At the end of the study period the investigators will collect performance data (the~          participants' accuracy at reading a series of chest x-rays) and process data (using~          gaze-tracking to evaluate the participants' search strategies); the experimental and~          control groups will be compared.~      Expected results:~      The investigators expect the group trained in expert search strategy to show improved~     accuracy at reading chest x-rays, and an improvement in their visual search strategy~   "
128645|NCT01883544|"~     The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), and~     pharmacodynamics (PD) of multiple intravenous (IV) doses of ALXN1007 in healthy male and~     female subjects.~   "
128646|NCT01883531|"~     It is hypothesised that inhaled mannitol 400 mg b.d. will lead to a significant improvement~     in the absolute change in percentage of predicted FEV1 from baseline following eight-weeks of~     trial treatment compared to treatment with inhaled placebo b.d.~      Any improvement in FEV1 is considered clinically meaningful; however, this trial has set a~     threshold of 3% for the purposes of determining an appropriate sample size for statistical~     power whilst retaining trial feasibility in an orphan disease population.~   "
128647|NCT01883518|"~     The purpose of this study is to achieving a six-month progression free survival (PFS) of~     patients receiving autologous dendritic cell vaccine (ADKV) loaded with allogeneic tumor~     lysate expression of cancer-testis antigens (CTA) in patients with soft tissue sarcomas~   "
128648|NCT01883505|"~     This phase 2a randomized double blind placebo controlled, in 30 Parkinson's disease (PD)~     subjects who are treated with oral levodopa/carbidopa (LD/CD) and suffer from motor~     fluctuations. The aim of the study is to determine the safety, tolerability, the levodopa~     pharmacokinetics, the need for oral LD dose adjustment and the usability of the ambulatory~     drug delivery pump following repeated dosing of ND0612 in a conventional home setting in~     Parkinson's disease patients. Safety and tolerability, pharmacokinetic profile of levodopa~     and carbidopa, pump usability and the potential clinical effect of ND0612 will be explored in~     subjects with PD and motor fluctuations.~   "
128649|NCT01883492|"~     The primary objectives of this clinical study include:~        -  Evaluate E1 Wear including early bedding-in process, clinical outcomes on patients who~          received Total Hip Arthroplasty with E1~        -  Compare E1 wear used with CoCr and Biolox Delta heads~   "
128650|NCT01883479|"~     The purpose of this study is to examine the efficacy of the active interventions (exercise or~     wellness/support intervention) compared to usual care on the prevention of postpartum~     depression among women at risk for depression. The investigators will also examine the~     efficacy of an exercise intervention compared to a wellness/support intervention on~     postpartum depressive symptoms among women at risk for depression.~   "
128651|NCT01883466|"~     Urban air pollution is a major contributor to greenhouse gases and has been shown to increase~     cardiovascular mortality and morbidity. This century has seen a rebirth of biofuel marketing~     and research, with biodiesel emerging as one of the strongest contenders within international~     markets. The pursuit of alternative renewable fuels is incredibly complex and has powered~     research in agriculture, biotechnology, production, transportation, feedstocks, ecology and~     biomass manufacturing. In spite of this, health effects have been an almost completely~     overlooked aspect. The purpose of this study is to investigate whether 100% biodiesel exhaust~     exposure in healthy volunteers leads to cardiovascular and inflammatory responses. Further~     investigations into the chemical composition of biodiesel exhaust will also be performed.~   "
128652|NCT01883453|"~     Healthy persons are invited to participate in the study and are given a home protocol~     (WURSS21), nasal spray and a sample pin. The included persons are told to make a~     nasopharyngeal sampling from the nose when they are sure that they have caught a common cold.~     After the sampling they start to spray and also fill in the records daily. The aim of the~     study is to investigate whether a nasal spray with glucose oxidase could shorten an episode~     of common cold.~   "
128739|NCT01882322|"~     The objective of this study is to compare the efficacy and safety between a group that has~     been on Prograf twice daily therapy but converted to Advagraf once daily therapy and a group~     that maintained Prograf twice daily therapy.~   "
128656|NCT01883401|"~     Berry anthocyanins have been shown to improve lipid profile in subjects with dyslipidemia~     while no such studies with whole strawberries have been reported in the US population. The~     investigators propose to examine the effects of low and high doses of freeze-dried~     strawberries on serum glucose, insulin, and lipid profile, biomarkers of oxidative stress and~     inflammation, in a 12-week randomized controlled trial. Subjects with abdominal adiposity and~     dyslipidemia (n=15/group) will be recruited at OUHSC and OSU, and randomly assigned to the~     low (25g/day) or high (50g/day) strawberry dose, or matched control (fiber and calories)~     group. The strawberry group will consume freeze-dried strawberry beverage (2 cups/day) and~     the controls will consume 2 cups beverage (fiber +calories) daily for 12 weeks. Blood draws,~     anthropometrics, blood pressure, and dietary data will be collected at screen, 6 and 12 weeks~     of the study to determine chronic and acute effects of strawberry intervention. Serum or~     plasma samples will be analyzed for fasting glucose, insulin, lipid profile including total~     cholesterol, LDL-, and HDL-cholesterol, triglycerides, lipid particle size, and levels of~     oxidative stress (malondialdehyde, oxidized LDL, myeloperoxidase), inflammation (high~     sensitivity C-reactive protein, adiponectin, interleukins) and adhesion molecules. Repeated~     measures ANOVA will be performed using a 5% significance level. We anticipate a dose response~     effect in decrease in lipids, oxidative stress or inflammation following strawberry~     intervention versus controls.~   "
128657|NCT01883388|"~     NovellusDx early detection test is a simple to perform blood test, which identifies the~     deregulated signaling pathways within the patient tumor based on protein secretion to the~     blood, thus enabling early stage disease signature detection. The investigators' current~     clinical trial is focused on proving the main feature of NovellusDx's Early Detection Test-~     discriminating between cancer patients and healthy subjects.~   "
128658|NCT01883375|"~     Dying patients and their families face many challenges near the end-of-life. Not only do~     patients often experience physical distress, but they also have feelings of loss of dignity,~     isolation, and uncertainty. Family members also face many challenges. They bear witness to~     the suffering of loved ones, and they face uncertainty, loss, and at times a mounting sense~     of helplessness.~      The purpose of this study is to introduce and evaluate a new intervention called Dignity~     Talk, meant to enhance end-of-life experience for both patients and their families. Dignity~     Talk is based on a set of questions by which terminally ill patients and their family members~     can engage in meaningful conversations with each other. It is intended to lessen feelings of~     loss and helplessness and enhance feelings of connectedness by facilitating conversations~     that tap into a sense of meaning and purpose, sharing of memories, wishes, hopes, and giving~     guidance to those who will soon be left behind.~      In Phase 1, 20 patients and family members will help finalize the method and Dignity Talk~     question framework (is it easy to understand, do the investigators have the right questions,~     and is the wording sensitive). In Phase 2 of the study the investigators will ask 100~     patient-family pairs for feedback about Dignity Talk: what influence it had on their~     palliative care experience, whether it works well, and whether this intervention should~     become a regular part of palliative care. The investigators will also ask for feedback from~     health-care providers in both phases. We are requesting approval for an amendment to the~     healthcare provider feedback focus group questions. Will add those documents when they are~     approved.~      Four to six months after the death of their loved one, the investigators will contact the~     family member to ask their thoughts about Dignity Talk, how it shaped their experience of~     their grief and bereavement.~      The investigators expect that the study will show that Dignity Talk can be an effective,~     highly accessible palliative care intervention, which will enhance the end-of-life experience~     for palliative patients and the families who support them.~   "
128659|NCT01883362|"~     To determine if the addition of midostaurin (PKC412) to Standard of Care (SOC) therapy~     reduces relapse in FLT3-ITD mutated AML patients receiving an allogenetic hematopoietic stem~     cell transplant,~   "
128660|NCT01883349|"~     The purpose of this study is to understand cognitive impairment in end stage renal disease~     before and after a kidney transplant.~   "
128661|NCT01883336|"~     This study intends to investigate the long term follow-up of small non-inflammatory~     pancreatic cysts.~   "
128662|NCT01883323|"~     This is a phase II clinical study for patients with metastatic (the cancer has spread to~     other parts of the body) melanoma. Patients will receive an infusion (given by vein) of~     autologous tumor infiltrating lymphocytes (TILs). TILs are a type of white blood cells that~     recognizes tumor cells and enter them which causes the tumor cells to break down.~      Prior to the cell infusion, patients will receive a two drugs cyclophosphamide and~     fludarabine to prepare the body to receive the TILs. After cell infusion, patients will~     receive low-dose interleukin-2 therapy which is an approved drug to treat melanoma. This~     study will see how useful this regimen is in treating metastatic melanoma.~   "
128663|NCT01883310|"~     Aims of the study:~      This is a double-blind randomized-controlled trial to test the effects of a task oriented~     training combined with cerebellar transcranial direct current stimulation on locomotor~     function, mobility and balance in multiple sclerosis subjects with moderate gait impairments~     (EDSS 4-5,5).~      Subjects and methods: 30 multiple sclerosis patients will be recruited in an outpatient~     rehabilitation clinic University Hospital Ferrara. Informed consent will be obtained.~     Participants enrolled will included in 2 different treatment groups: Task Oriented Circuit~     Training (TOCT) + anodal cerebellar transcranial direct current stimulation (experimental~     group) and TOCT + sham transcranial direct current stimulation over the cerebellum (control~     group). The group with anodal transcranial direct current stimulation will receive continuous~     stimulation with intensity of 2 mA during the first 15 minutes of functional circuit~     training. In the sham session, anodal transcranial direct current stimulation was applied for~     30 s and then shut off. Each subject will receive 10 task-oriented training sessions over 2~     weeks (5 sessions/week). 3 subjects with a supervisor physiotherapist will take part at the~     TOCT. During the stimulation sessions both the subject and the researcher, responsible for~     carrying out clinical tests, will be unaware of the type of stimulation set.~      Treatment efficacy outcome measures will be clinical test for gait speed (Timed 25-Foot~     Walk), walking endurance (six minute walking test), balance (Dynamic Gait Index) and mobility~     (Time Up and Go Test); self-assessment questionnaire for motor fatigue (Fatigue Severity~     Scale FSS) and quality of life (Short Form (36) Health Survey).~      Outcome measures will be assessed the week prior to treatment initiation (T0), the week after~     the end of treatment (T1) and at 3 months follow-up (T3) to evaluate treatments retention, by~     a clinician blinded to the treatment. At the end of each session, the subject will complete a~     questionnaire where report side effects due to stimulation (headache, neck pain, burning,~     redness and/or itching in the site of stimulation).~   "
128664|NCT01883297|"~     This is a phase I clinical study for patients with platinum resistant (does not respond to~     platinum-based chemotherapy) high grade serous ovarian, fallopian tube, or primary peritoneal~     cancer. Prior to the main treatment, patients will receive cyclophosphamide by vein. Patients~     will then receive an infusion (given by vein) of autologous tumor-infiltrating lymphocytes~     (TILs) which will first be taken from the patient, then be stimulated with certain substances~     called autologous dendritic cells (DCs) and OKT3 (anti-CD3 antibody), and then given back to~     the patient as an infusion. This is believed to make the TILs work better. TILs are a type of~     white blood cells that recognizes tumor cells and enter them which causes the tumor cells to~     break down. After infusion of TILs, low-dose interleukin-2 (IL-2) therapy will be given.~   "
128665|NCT01883284|"~     Epigenetic modifiers has been showed to rescue F508del-CFTR channel to apical membrane of~     epithelial cell lines. In this study, the investigators evaluate epigenetic modifiers effects~     firstly on CFTR rescue, then on secretion and synthesis of inflammatory factors (IL-8, LXA4~     and SCGB1A1) and mucines (MUC5AC and MUC5B) in a dynamic epithelium model using an~     air-liquide interface culture of nasals cells from CF patients or controls.~   "
128666|NCT01883271|"~     Study objectives:~        1. To compare cardiovascular function in older compared to young healthy adults.~        2. To compare the effect of 8 weeks of aerobic interval training vs. continuous moderate~          exercise on cardiovascular function in healthy older adults.~      Hypotheses:~        1. Compared to young adults, older adults will have lower cardiovascular function.~        2. Compared to continuous moderate intensity exercise training, interval training will be~          more effective in improving cardiovascular function in older adults.~   "
128667|NCT01883258|"~     The study objectives are:~        1. To compare cardiovascular function in type 2 diabetes patients vs. healthy controls.~        2. To compare the effect of 8 weeks of aerobic interval training versus continuous moderate~          exercise on cardiovascular function in adults with type 2 diabetes.~        3. To examine the mechanisms underlying the exercise-related changes in cardiovascular~          function.~      The investigators hypothesize that compared to continuous moderate intensity exercise~     training, interval training will be more effective in improving cardiovascular function in~     adults with type 2 diabetes.~   "
128668|NCT01883245|"~     Patients affected by chronic orofacial pain represent an emergent medical problem due to the~     lack of knowledge on the cause, pathophysiology and psychology of many of these conditions,~     that belongs to a multifactorial origin.~      Particularly, temporomandibular joint disorders involve a series of symptoms that refers both~     to intrinsic and extrinsic joint conditions where pain can be associated to a reduction of~     the joint movement, click or to other sounds of the joint.~      The lack of a recognized causal therapy led to the suggestion of many treatment modalities~     with a multidisciplinary approach for the management of symptoms that include the use of~     occlusal splints, physiotherapy-speech therapy, behavioral and physical therapy, drugs,~     chirurgical approaches. In most cases these strategies together allow the control of the~     symptoms, even though they aren't completely resolutive.~      In these patients is frequent chronic pain and ineffectiveness of common drugs used.~      It has been demonstrated how transcranial electrical brain stimulation with direct current~     (tDCS) is able to reduce the intensity and the duration of chronic pain.~      Stimulating the motor cortex can reduce pain by modulating brain activities in the areas~     involved in cerebral circuits controlling pain, such as thalamus, facilitating the descendant~     inhibitory mechanisms and enhancing the number of opiates receptors.~      This clinical trial is based on the evaluation of the effects of tDCS on pain and on~     activities daily living (ADL) participation patients with chronic orofacial pain that don't~     respond to other treatments.~   "
128669|NCT01883232|"~     As a dentist, administering anesthetic to patients, especially children, proves to be one of~     the most difficult parts of a procedure. Pain is one of the most common symptom in dentistry,~     and a serious concern for the dentist. The pain of the local anesthetic injection has several~     causes. Of the many reasons for pain at the site of injection, the acidity of the solution is~     thought to be most important. This study will be measuring the effects of adding sodium~     bicarbonate (buffer) to local anesthetic during dental procedures. This is commonly used in~     medical applications but is not widely used in the dental setting. Using this biochemistry~     and human physiology, one can predict when buffering the lidocaine injection, a quicker~     response in analgesia and a decrease in pain during administration. I will be measuring the~     effect using several measuring devices to gauge if buffering the local anesthetic will~     benefit the pediatric dental patient by reducing the time it takes for the analgesic effect~     as well as decreasing the pain during administration. Along with time, I will be using the~     Wong-Baker Scale to assess the pain. This scale is standard protocol for assessing pain in~     the pediatric population. The pediatric dental population has aversions to dental procedures~     because of the associated pain produced from most procedures. If limiting the time it takes~     for the analgesic to take effect and decrease the pain altogether, the pediatric patient will~     be less likely to skip treatment therefore, increase dental health.~   "
128670|NCT01883219|"~     The purpose of this study is to evaluate the efficacy of tyrosine kinase inhibitor(TKI)~     therapy based on molecular monitoring of BCR/ABL levels in Philadelphia chromosome-positive~     acute lymphoblastic leukemia (Ph+ ALL)undergoing allogeneic hematopoietic stem cell~     transplantation(allo-HSCT).~   "
128671|NCT01883206|"~     The purpose of this study is to see how well the antibody levels found months to years after~     patients entered a previous randomised placebo-controlled trial of a glycoprotein B vaccine~     against cytomegalovirus have persisted and to have the previous samples retested using~     different methods which have been further developed in different laboratories.~      Also, to prepare monoclonal antibodies from the B lymphocytes of these patients and define~     their strength. If potent antibodies are identified, the investigators would like to consider~     developing them further to see if they can protect future transplant patients against~     cytomegalovirus.~   "
128672|NCT01883193|"~     Multi-country three-arm, individually randomized, non-masked, controlled trial to ascertain~     the benefits of ensuring optimal maternal nutrition before conception and providing an~     evidence base for programmatic priority directed to minimizing the risk of malnutrition in~     all females of reproductive age.~   "
128673|NCT01883180|"~     The purpose of this study is to compare the incidences of GVHD and viral infections in~     haploidentical hematopoietic stem cell transplant recipients receiving different dose of~     antithymocyte globulin (ATG) for acute graft-versus-host disease(aGVHD) prophylaxis. Our~     first objective was to investigate the optimal dose of ATG for aGVHD and second object was to~     evaluate the effect of different dose of ATG on post-transplant viral infection.~   "
128674|NCT01883167|"~     This study will evaluate the potential pharmacokinetic (PK) and pharmacodynamic (PD)~     interaction between the XO inhibitor febuxostat and the investigational URAT1 inhibitor~     RDEA3170 and provide information for potential future clinical studies using this~     combination. Combination treatment using 2 drugs with different mechanisms of action may~     achieve improved response and may allow the use of lower doses, resulting in fewer side~     effects than the use of either drug alone.~   "
128675|NCT01883154|"~     Genetic and environmental factors are believed to play a major role in intrauterine growth~     and intrauterine programming. We intend to study genetic factors such as Telomere~     homeostasis, senescence, genomic instability and the presence of Genomic copy number~     variations in placental tissue from pregnancies complicated with Intrauterine growth~     restriction(IUGR), Gestational and pre gestational Diabetes, placentas from IVF pregnancies~     and from normal pregnancies. We also intend to assess these factors in cord blood and~     maternal blood.~   "
128677|NCT01883128|"~     Radiotherapy is the commonest form of prostate cancer treatment in the UK. In one in four~     men, radiotherapy will fail to control the cancer. These men are offered hormonal treatment~     which has significant side effects. Few men are offered a further treatment such as surgery,~     HIFU or cryotherapy. Only half of these men are cancer free at 5 years. The investigators~     believe this is due to poor imaging tests such as CT and Bone scan that cannot accurately~     detect whether cancer has come back inside or outside of the prostate or both. Also~     radiotherapy damages tissue surrounding the prostate which affects tissue healing for example~     after surgery. Treating just the cancer in the prostate only (focal treatment) rather than~     the whole prostate may limit this damage and cause fewer side-effects. The investigators want~     to see if new imaging tests can better identify cancer that has spread outside of the~     prostate and areas of cancer inside the prostate. Our new tests are whole-body MRI (for~     distant disease) and MRI guided biopsies (MRI-TB) (for local disease). First, the~     investigators will compare the results of whole-body MRI to existing imaging tests~     (bone-scan, and choline PET/CT) that try to find distant spread. Second, the investigators~     will compare the results of MRI-TB to a very detailed and accurate biopsy of the prostate~     called template prostate mapping which will show us where and how aggressive the cancer is.~     Third, if the cancer is confined to the prostate, the investigators will treat men using~     focal salvage therapies HIFU and cryotherapy. The investigators believe that these new~     imaging tests could better identify those who will benefit from early hormone treatment and~     those who will benefit from local salvage treatment. Our study may help justify carrying out~     a larger trial looking at how good the treatment is in controlling cancer in the medium and~     long-term.~   "
128678|NCT01883115|"~     Our recent prospective randomized controlled study comparing single-port vs. multiport~     laparoscopic total extraperitoneal inguinal herniorraphy (NCT 01660048) demonstrated~     superiority of the single-port technique in reducing post-op pain/analgesic requirements,~     quicker return to work/normal physical activities and improved cosmetic scar scores. During~     this study all patients underwent the initial extraperitoneal dissection with the distension~     balloon. However, the balloon itself costs AU $380 per device which represents a significant~     percentage of the overall cost of the procedure (when the hospital/operating rooms cost is~     approximately AU $2500 for a unilateral laparoscopic inguinal hernia repair) especially if~     only unilateral inguinal herniorraphy is performed.~      The European Hernia Society Guidelines encourage the use of the distension balloon for the~     initial distension/dissection of the extraperitoneal space especially during the learning~     curve. This recommendation arises from the fact that during the conventional multiport repair~     the umbilical port allows only the insertion of the laparoscope and the extraperitoneal space~     cannot easily be dissected with the scope itself, especially in patients with well-developed~     linea alba extending down to the pubic symphysis, and the camera itself, if used as~     dissection device, would become smudged and it would have to be repeatedly withdrawn for~     cleaning. Yet this must occur since the extraperitoneal space must be dissected in the~     midline sufficiently for safe insertion of two additional 5 mm ports for insertion of~     dissecting instruments in order to complete the extraperitoneal space dissection and the~     repair.~      With single incision laparoscopic surgery the use of the Triport™ system ensure that the port~     can be place under direct vision into the extraperitoneal space when the scope and two~     dissecting instruments can be safely inserted at the outset. In this way the extraperitoneal~     space can be dissected under direct vision. The balloon dissection is essentially a blind~     dissection even though the balloon distension is being observed by the scope, incorrect~     tissue planes can be entered ie the dissection can occur below the pre-peritoneal fascia~     exposing the nerves in the groin with the potential risks for nerve damage and entrapment.~     This is an argument that surgeons who practise transabdominal preperitoneal inguinal hernia~     repair use to justify their superior technique over the TEP repair because, in the TAPP~     repair, the peritoneum is carefully dissected free from and leaving the underlying~     preperitoneal fascia intact.~      While the use of the balloon, when some 25 pumps of air are used during the insufflation,~     to create a significant space to place not only the two 5 mm ports but also to create a~     significant extraperitoneal dissection when usually only the lateral space and the hernia sac~     need to be dissected this is not always possible. In patients who have had previous lower~     abdominal surgery including previous anterior inguinal herniorraphy (especially if the mesh~     plug is used) the balloon dissention is normally judicious as one cannot predict whether~     there are any significant peritoneal or even bowel adhesions. Consequently, in such cases,~     the balloon distension is normally confined to an area just inferior to the umbilical port~     and superior to the pubic symphysis so that there is just enough extraperitoneal dissection~     to place the two 5 mm trocars. Usually this means only using only 5 pumps of air in the~     distension balloon for placement of two 5 mm trocars. Then the dissection of the~     extraperitonealy space under direct vision can take place. The use of the distension balloon~     in such cases represents an enormous waste of resources since AU $380 is spent just to create~     enough space to place the two 5 mm ports and hence allowing the insertion of the dissecting~     instruments. With the Triport+™ port the dissecting instruments can easily be placed in the~     extraperitoneal space and the dissection can begin under direct vision hence achieving the~     same safe dissection that TAPP surgeons claim to perform.~      In this study we aim to look at the safety and efficacy of telescopic vs. balloon dissection~     by prospectively comparing a similar former group of patients to the ones who had previously~     undergone single-port inguinal herniorraphy with balloon dissection in our previous study~     (NCT 01660048).~      All patients having surgical treatment of groin hernia at St Luke's and Holroyd Private~     Hospitals are subject to very careful assessment and study. All patients are requested to~     report immediately if there are any problems.~   "
128679|NCT01883102|"~     This is a study of epidermal (the outer most layer) nerve fibers (ENFs) in the skin of the~     body; counts of which are used to determine a disease of nerves called small nerve fiber~     neuropathy.~      Capsaicin is approved by the Food and Drug Administration (FDA) for pain relief. Since 0.1%~     capsaicin is known to cause ablation (removal) of ENFs, this study will test whether such~     ablation results in relief of spontaneous pain, touch, or heat-pain.~   "
128680|NCT01883089|"~     The current study combines both clinical trial and daily process methodology to examine the~     dynamic longitudinal relationships between daily approach and avoidance inclinations (i.e.,~     craving) and drinking behaviors in those diagnosed with an Alcohol Use Disorder (AUD) prior~     to, during, and after receiving a brief alcohol intervention. It is hypothesized that daily~     avoidance inclinations will significantly moderate the effect of daily approach inclinations~     on drinking behaviors, and that significant increases in avoidance inclinations will be~     observed prior to treatment entry, followed by significant decreases in approach inclinations~     during treatment.~   "
128681|NCT01883076|"~     This is a Phase I study to determine the safety and feasibility of injections of autologous~     umbilical cord blood (UCB) cells into the right ventricle of Hypoplastic Left Heart Syndrome~     (HLHS) children undergoing a scheduled Glenn surgical procedure.~      The investigators are doing this research study to find out if autologous stem cells from the~     individual's own umbilical cord blood can be used to strengthen the muscle of the right side~     of their heart. This will help determine the safety and feasibility of using cell-based~     regenerative therapy as an additional treatment for the management of HLHS.~   "
128682|NCT01883063|"~     This is a prospective multi-site study. Subjects with distal radius fractures will be~     enrolled. Subjects will be treated surgically with a Sonoma WRx™ device or managed~     non-operatively with a splint or cast. Subjects will be enrolled in each group according to~     physician's standard of care (either casting/splinting or surgery) for distal radius~     fractures. Subjects will be enrolled based on the study's inclusion/exclusion criteria with a~     final qualifying decision made by a group of three independent adjudicators. The final~     qualifying review should allow for similar patient groups within each arm of the study due to~     the variability that can arise in fracture classification. Review by the adjudicators should~     be completed within 1 week.~   "
128683|NCT01883050|"~     Patients who recently suffered a heart attack will use a smart-phone/computer application~     during cardiac rehabilitation to reduce their risk of a future attack, their~     re-hospitalizations, their cost of care, and increase their quality of life.~   "
128684|NCT01883037|"~     There are very few studies comparing the accuracy, sensitivity and specificity of HemoCue~     glucose 201 RT system with the laboratory gold standard.~      The incidence of cystic fibrosis related diabetes (CFRD) has risen significantly as patients'~     survival improves. Around 30% of all cystic fibrosis (CF) adult patients have CFRD. Early~     diagnosis of CFRD is important to slow the deterioration of lung function and nutritional~     status, both of which increase mortality.~      The oral glucose tolerance test (OGTT) is the accepted method for detecting CFRD and the~     Cystic Fibrosis Trust guidelines recommend that patients with CF over the age of twelve years~     should be screened annually.~      The World Health Organisation has pointed out that due to the absence of a more specific~     biological marker to define diabetes, plasma glucose estimation remains the basis of~     diagnostic criteria. WHO recommends that venous plasma glucose should be the standard method~     for measuring and reporting glucose concentration in blood. However, it has also recognised~     that there is a widespread use of capillary sampling. Although fasting values for venous and~     capillary plasma glucose are the same, in the nonfasting state capillary samples will give~     higher results than venous samples, and glucose values require conversion which can be~     problematic.~      HemoCue Glucose 201 RT (HGS 201 RT) analyzer with plasma conversion provides laboratory~     quality test results at the point of care for the diagnosis, screening and monitoring of~     diabetes mellitus. The analyzer is easy to use and the system can be operated by~     nonlaboratory personnel, also the results can be presented immediately, leading to~     significant time and resource saving. The patient also benefits from having the result~     immediately instead of waiting for several hours. With immediate result, the doctor and~     health care professionals can provide education, support and reassurance, and implement care~     plans, if appropriate, at the earliest opportunity.~      The aim of the study is to compare the clinical accuracy of HemoCue Glucose 201 RT with the~     laboratory standard method in the analysis of blood glucose concentration during oral glucose~     tolerance test.~   "
128685|NCT01883024|"~     The purpose of the study is to assess the relevance of the advices provided by the IPRA©~     smartphone application for guiding the responses of insulin pump treated type 1 diabetes~     patients using real-time continuous glucose monitoring.~   "
128686|NCT01883011|"~     The aim of this study was to confirm the efficacy of piracetam after 12 weeks of treatment on~     the aphasic status of subjects suffering from aphasia after acute ischemic middle cerebral~     artery stroke and having received their medication within 7 h post-stroke onset.~   "
128687|NCT01882998|"~     This study aims to test the effectiveness of a behavioral intervention aimed at preventing~     the primary acquisition of HIV by uninfected pregnant and lactating women in Uganda, East~     Africa where HIV transmission is high. Women who acquire HIV during pregnancy or lactation~     are at higher risk of adverse health and pregnancy outcomes and their baby is at high risk of~     acquiring HIV and dying.~      Keeping HIV-uninfected women uninfected during pregnancy and lactation is an important~     component of the global World Health Organization (WHO) strategy to eliminate mother-to-child~     transmission of HIV but there has been no study to date to assess interventions that can~     effectively keep these women uninfected.~      In this study, the investigators will test the hypotheses that:~        1. extended repeat HIV testing and enhanced counseling (ERHTEC) during late pregnancy (>36~          weeks) and breastfeeding can increase and sustain risk reduction behaviors and prevent~          incident STI and HIV infections among HIV-uninfected pregnant women, and~        2. that couple HIV testing and counseling (HTC) can further enhance this effect through~          improved couple communication and emotional and economic support from male partners.~   "
128688|NCT01882985|"~     This phase II trial evaluated the impact of giving docetaxel together with lycopene~     supplements in treating patients with hormone-resistant prostate cancer not previously~     treated with chemotherapy. Drugs used in chemotherapy, such as docetaxel, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Chemoprevention is the use of certain drugs, such as lycopene, to keep cancer from~     forming. Giving docetaxel together with lycopene may be an effective treatment for prostate~     cancer.~   "
128689|NCT01882972|"~     Despite a robust literature on the benefits of exercise for cancer survivors, most of the~     research to date falls in two primary areas - aerobic exercise and breast cancer survivors.~     The focus on aerobic training alone is a concern as resistance training is critical for~     building the muscle mass necessary to maintain physical function. However, concerns have been~     raised about the potential for higher than tolerated adverse event rates during resistance~     training, particularly that which is unsupervised, despite a history of safe use of~     resistance training in other chronically diseased patient populations. The aim of this pilot~     study is to demonstrate the feasibility, safety and quality of life benefit of a home-based~     resistance-training program among colorectal cancer survivors. The investigators will recruit~     n=30 men and women with stage I-III colon cancer. Participants will be randomized to a~     home-based exercise intervention that combines aerobic and resistance exercise. Control arm~     participants will receive a home-based meditation program.~   "
128690|NCT01882959|"~     The meta-analysis of data obtained from randomized controlled trial on effectiveness of~     radiofrequency denervation on reducing chronic neck and low back pain.~   "
128691|NCT01882946|"~     The study comprises a Phase I component during which the optimal dose of DCVax-Direct for the~     treatment of solid tissue tumors will be identified, followed by a Phase II component to~     determine if the injection of DCVax-Direct into selected solid tissue tumors has the ability~     to reduce tumor growth.~   "
128692|NCT01882933|"~     A prospective, opened, multicentric, randomised, phase III trial with two arms:~        -  Arm A: curative gastrectomy with D1-D2 lymph node dissection + HIPEC with oxaliplatin~        -  Arm B: curative gastrectomy with D1-D2 lymph node dissection~      Main objective: Compare overall 5-year survival rates in patients surgically treated for~     advanced gastric adenocarcinoma (T3, T4 and/or N+ and/or with positive peritoneal cytology),~     treated either with curative gastrectomy and adjuvant HIPEC, or with curative gastrectomy~     alone.~   "
128693|NCT01882920|"~     The aim of the study is to assess whether in cytoreductive surgery (CRS) and hyperthermic~     intraperitoneal chemotherapy (HIPEC) the use of a protocol of intravenous fluid therapy~     combined with goal directed fluid therapy (GDT) is associated with a significant change in~     morbidity, length of hospital stay and mortality compared to a standard fluid therapy.~     Patients undergoing CRS and hipec are randomly divided into two treatment groups. The GDT~     group receive fluid intravenous therapy according to a specific treatment protocol guided by~     monitored hemodynamic parameters assessed using the arterial pressure signal monitoring to~     assess stroke volume and cardiac output via an automated pulse contour analysis~     (Flotrac/Vigileo®); the control group receive the standard fluid therapy (crystalloid and~     colloid). Fluid therapy regimen is free in the control group and targeted in the GDT group.~     In both groups, the investigators evaluate the incidence of major abdominal and systemic~     complications, the total duration of hospital stay, mortality, the total amount of fluids~     administered, their breakdown (crystalloid/colloid) and the total number of colloid boluses~     administered.~   "
128694|NCT01882907|"~     The purpose of this study is to compare the effect of 16 weeks treatment with vildagliptin to~     pioglitazone as add-on the therapy to metformin in patients with type 2 diabetes inadequately~     controlled with metformin monotherapy.~   "
128695|NCT01882894|"~     The aim of this randomized control trial is to identify the possible effectiveness of the~     temporary use of an inexpensive, custom-made plantar fascia orthotic (PFO).~   "
128696|NCT01882881|"~     The purpose of this study is to investigate the individual and combined effects of dark~     chocolate/cocoa and almonds on lipids, lipoproteins, antioxidant defense, lipid peroxidation,~     phenolic acids, inflammatory status, blood pressure and arterial health. It is hypothesized~     that dark chocolate/cocoa and/or almonds will favorably affect lipids, lipoproteins,~     antioxidants, inflammatory status, blood pressure and arterial health compared to a healthy~     American control diet; however, the effects will be greater when dark chocolate/cocoa and~     almonds are consumed together versus consumption of each food individually.~   "
128697|NCT01882868|"~     Primary Objective:~      To assess efficacy aflibercept + 5-fluorouracil (5-FU)/levofolinate/irinotecan (FOLFIRI) by~     objective response rate (ORR).~      Secondary Objective:~      To assess the following:~        -  safety profile;~        -  progression free survival (PFS);~        -  overall survival (OS);~        -  pharmacokinetics (PK);~        -  immunogenicity.~   "
128698|NCT01882855|"~     Hepatic encephalopathy (HE) is a potentially reversible, metabolically caused complication of~     acute or chronic liver diseases such as cirrhosis. Due to the diseased liver's inability to~     remove toxins such as ammonia, which is produced in the gastrointestinal tract, the ammonia~     accumulates in the brain and causes forgetfulness, confusion, disorientation, concentration~     and memory problems, changes in mood, decreased alertness and responsiveness, changes in~     sleep habits, muscle tremors and stiffness, speech impairments, uncontrollable movements,~     agitation.~      This study will examine music as a possible external factor that could contribute to~     impairment in attention and progressive memory in cirrhotic patients while driving.~     Sustaining attention is important for learning and remembering new information, for e.g.~     keeping the car within lane and paying attention to cyclists and pedestrians. Prospective~     memory is the ability to remember to perform previously intended tasks at the appropriate~     time or occasion, for instance remembering the correct exit while driving on the highway.~     Impairment in any of these areas may result in serious consequences for patient with~     cirrhosis. There is evidence that some subsets of cirrhotic patients have a diminished~     ability to drive and significantly more motor vehicle crashes and traffic violations. In~     these patients, listening to music while driving may further jeopardize their driving~     ability, which in turn may lead to reduced quality of life and increased medical costs (from~     motor vehicle accidents).~      This is a cross-sectional study designed to determine if there is any effect of listening to~     music on attention and prospective memory in patients with cirrhosis. For these purposes,~     subjects will be asked to come for one study visit, which will last approximately 2 hours.~     During this visit, subjects will undergo a series of screening procedures (consent,~     assignment of subject identification number, demographics, medical history, physical~     examination, vitals, height, weight, and eligibility assessment). If they are found eligible,~     subjects will undergo several neuropsychological assessments to measure any effect of music~     on attention and prospective memory. These assessments include including Number Connection~     Test (NCT), Digit Symbol Test (DST), Cambridge Prospective Memory Test (CAMPROMPT) and~     Inhibitory Control Test (ICT).~   "
139651|NCT01739426|"~     The primary objective of this study is to evaluation the success of endoscopic treatment of~     Zenker's diverticulum using a LigaSure device (thermal fusion of vessels) via a measure of~     swallowing function at 12 months post-surgery.~   "
128699|NCT01882842|"~     This study aims to see if taking a small sample from the lining of the womb (the 'scratch')~     before starting in vitro fertilization (IVF) treatment can influence the chance of getting~     pregnant and having a healthy, term baby.~      This study also aims to explore why an embryo is not accepted or indeed rejected by the~     lining of the womb. This will be analysed by carefully looking at the sample taken from the~     lining of the womb under the microscope and analysing the levels of natural killer (NK)~     cells. These cells are thought to regulate the implantation process and to be altered in some~     women with infertility and miscarriage.~   "
128700|NCT01882829|"~     There is an urgent need, therefore, to identify well-tolerated, orally available compounds~     that target the NMDA receptor as a novel treatment approach for TRD. The current project aims~     to test the safety, tolerability and efficacy of Nuedexta - containing the NMDA antagonist~     dextromethorphan.~   "
128701|NCT01882816|"~     The purpose of this Phase 2 study is to find out what effect, good and/or bad, external beam~     radiation therapy, has on the patient and their thyroid cancer where surgery is not an option~     or where despite surgery, the disease is still present.~   "
128702|NCT01882803|"~     Phase 2 clinical trial to evaluate the safety and efficacy of IPI-145 as a monotherapy in~     subjects with iNHL (Follicular Lymphoma, Marginal Zone Lymphoma, or Small Lymphocytic~     Lymphoma) that is refractory to rituximab and to either chemotherapy or RIT.~   "
128703|NCT01882790|"~     Autonomic nerve function is involved in both blood pressure (BP) regulation and the~     pathogenesis of coronary artery spasm(CAS), but few studies have been published about the~     relationship between CAS and effect of BP lowering drugs in patients with hypertension. The~     purpose of this study is to investigate the incidence of CAS, atrioventricular (AV) block and~     effect of BP lowering drugs on CAS in hypertensive patients treated with BP lowering agents.~     The investigators will register consecutive patients who underwent coronary angiography with~     an acetylcholine (Ach)-induced provocation test. The investigators will include hypertensive~     patients who were taking antihypertensive drugs, and exclude patients who had a documented~     history of cardiovascular disease or who were not treated with antihypertensive agents. CAS~     is defined as >70% luminal narrowing on Ach provocation and /or concurrent chest pain. The~     study population will be divided into quartiles of rising systolic BP and diastolic BP. The~     incidence of Ach-induced CAS according to each systolic BP/diastolic BP quartile will be~     evaluated.~   "
128704|NCT01882777|"~     DelAgua Health and Development, Manna Energy and the Rwanda Ministry of Health are~     collaborating on a project financed by carbon credits that will distribute household-based~     water filters and high-efficiency cook stoves to approximately 700,000 households in Rwanda.~     Prior to the full roll out of the campaign, the implementers are conducting a pilot project~     among 2000 households in western Rwanda. The objectives of this pilot evaluation are to~     document the delivery of the intervention to the intervention population, assess coverage and~     uptake of the intervention target households and conduct a 5-month randomised controlled~     trial among 500 households to assess the impact of the intervention on drinking water quality~     and indoor air quality.~   "
128705|NCT01882764|"~     A study with an 8 week open label phase study followed by a year long placebo controlled~     maintenance phase in subjects with active mild to moderate ulcerative colitis (UC), with a~     modified Mayo Score 4-10 and an endoscopy subscore of 2-3, taking mesalamine (or equivalent)~     as a concomitant medication. Subjects are required to be in clinical remission or clinical~     response to enter the year long maintenance phase. This study will help evaluate if HMPL-004~     is effective in subjects maintaining clinical remission following successful induction~     therapy achieving clinical remission or clinical response.~   "
128706|NCT01882751|"~     A better understanding of knee joint kinematics is important to explain the premature~     polyethylene wear failures within total knee arthroplasties (TKAs) and to help design a~     prosthesis that most closely approximates the normal knee. Previously, most experimental~     studies of knee kinematics have involved cadaveric, in vitro analyses, or have not tested the~     knee in a weight-bearing mode. Others have used exoskeletal linkages and skin markers that~     permit error due to undesired motions between markers and the underlying bone. More recently,~     fluoroscopy has been used to assess in vivo kinematics for subjects having a TKA.~      ConforMIS has attempted to follow a clearly different path than the major orthopaedic~     companies. They have chosen to offer patients a personalized knee implant based off of each~     patient's femoral and tibial bone geometry. The hypothesis is that these subjects will~     experience a more normal-like kinematic pattern, eliminating paradoxical anterior sliding~     during weight-bearing knee flexion. Therefore, the objective for this study is to analyze the~     in vivo kinematics for 25 patients implanted with a personalized ConforMIS TKA and 25~     patients implanted with a traditional TKA design to determine if there are any kinematic~     differences between these TKA designs.~   "
128707|NCT01882738|"~     All consecutive pregnant patients in 2nd or 3rd trimester will be asked to participate.~     Cervical length will be assessed in all patients, once abdominally and then vaginally (that~     would serve as golden standard). Correlation would be assessed between accuracy of~     measurement to BMI~   "
128708|NCT01882725|"~     The purpose of this study is to determine whether low level laser light therapy is effective~     in increasing local blood circulation in people with chronic heel pain arising from plantar~     fasciitis.~   "
128709|NCT01882712|"~     The purpose of this study is to compare the efficacy and assess the safety of CD07805/47 gel~     0.5% applied topically once daily for 29 days versus vehicle control, in subjects with~     moderate to severe chronic persistent vascular facial erythema~   "
128735|NCT01882374|"~     The purpose of this study is to evaluate the efficacy of TXA127 to reduce the incidence~     (Grade II-IV) of acute Graft-vs.-Host Disease (aGVHD) in adult subjects undergoing double~     umbilical cord blood transplantation (UCBT). The study will also evaluate the effects of~     TXA127 on incidence, severity and duration of mucositis; neutrophil engraftment and platelet~     recovery; platelet transfusion requirements; immune reconstitution; and duration of~     corticosteroid use. TXA127 has shown to be well tolerated by patients and appears to induce~     rapid production of neutrophils and platelets in the bloodstream, as well as increase the~     immune system components. TXA127 has also been shown reduce the severity of~     chemotherapy-induced mucositis.~   "
128740|NCT01882296|"~     Primary object: Evaluate Pharmacodynamic property and safety administered S-pantoprazole 10,~     20, 40mg and Pantoprazole 20, 40mg in healthy male subjects~      Secondary object : Evaluate Dose-response of S-pantoprazole and pantoprazole and compare each~     dose-response~   "
128710|NCT01882699|"~     This study will build upon a previously approved protocol entitled A multi-center~     prospective, blinded, randomized crossover study to compare the Cerêve Sleep System at two~     different temperatures in primary insomnia patients (CIP-003; CER1-01-090). In that study,~     150 insomnia patients were targeted to be randomized to complete in lab assessments of sleep~     using the Cerêve Sleep System. In this follow-on study, 36 patients who completed the in lab~     study will be enrolled to complete 2 phases of in home use of the device. In the first phase,~     the durability study, 30 patients are targeted to complete additional in lab assessments~     following 30 days of in home use of the device. In the second phase, the home use pattern~     study, 24 patients are targeted to complete an additional 5 months of in home use in which~     their use patterns will be monitored.~      Hypothesis:~      EEG sleep latency and sleep efficiency following 30 days in home use of the device at 14-16°C~     will be similar to those measures after the initial acute, 2-night use in the parent study in~     the 14-16°C condition. The device will demonstrate a benign safety profile over 6 months in~     home use.~   "
128711|NCT01882686|"~     A series of case-studies to explore the efficacy of classification based cognitive functional~     physiotherapy according to the classification system proposed by Peter O'Sullivan in specific~     nursing population with non specific chronic low back pain.~      The investigators hypothesis was that treatment targeting the mechanisms behind the problem~     from a multidimensional perspective would be effective to reduce pain, disability and~     sick-leave.~   "
128712|NCT01882673|"~     The long-term goal of this program of research is to disseminate an effective, brief~     computer-based intervention that can be readily integrated into Substance Use Disorders (SUD)~     treatment programs to motivate tobacco quitline use in patients who smoke. The overall~     objective of this application, which is the first step in the attainment of this long-term~     goal, is to fully develop this computer-based intervention, modify it based on initial~     piloting and feedback to insure its feasibility and acceptability, and obtain preliminary~     data supporting the efficacy of the intervention. This will be accomplished by pursuing three~     specific aims: 1) to develop and conduct preliminary pilot testing (n=20) of a brief,~     computer-based intervention intended to motivate tobacco quitline use among cigarette smokers~     in SUD treatment (TIME-TQ; Tablet computer Intervention to Motivate Engagement in Tobacco~     Quitline use) and to develop and pilot test a computer-based, time matched control~     intervention (CON), 2) to conduct a preliminary randomized controlled trial (RCT) with 60~     smokers in SUD treatment, comparing TIME-TQ vs. CON, with predictions that TIME-TQ relative~     to CON will result in increased readiness, higher rates of tobacco treatment engagement, more~     quit smoking attempts and higher rates of 7-day point prevalence abstinence rates at 1- and~     3-month follow-ups. Substance use outcomes over the course of the 3-month follow-up period~     will also be examined, and 3) to examine TIME-TQ's effects on key mechanisms during the~     computer session and their associations with tobacco treatment engagement and smoking~     outcomes at 1- and 3-month follow-ups.~   "
128713|NCT01882660|"~     Background of the study: Colon cancer is the second leading cause of cancer-related death~     world wide.~      Although patients presenting with early disease (stage I-III) can be cured, prognosis varies~     from 90% in stage I to 50-80% in stage II and III. Therefore, prevention of metastases after~     early disease is of utmost importance. Derepression of Wnt targets may provide a novel target~     for therapy.~      Objectives: The primary objective of the study is to assess in patients with primary colon~     cancer whether short-course pre-operative treatment with decitabine can increase Wnt target~     gene expression as measured in resected tumors compared to pretreatment biopsies. The~     secondary objective of the study is to assess in patients with primary colon cancer whether~     short-course pre-operative treatment with decitabine can revert CpG methylation and induce~     more favorable tumor characteristics as measured in resected tumors compared to pretreatment~     biopsies. The tertiary objective is to compare changes in Wnt target gene expression, CpG~     methylation and tumor characteristics for Wnt methylated and nonmethylated tumors as measured~     in resected tumors compared to pretreatment biopsies and identify new stratification markers.~   "
128714|NCT01882647|"~     This Phase 3 study has been designed to determine and compare the efficacy and safety of~     000-0551 Lotion and Vehicle Lotion applied twice daily for two weeks in subjects with plaque~     psoriasis.~   "
128715|NCT01882634|"~     To determine the prevalence of Abdominal Aortic Aneurysm (AAA) in the Spanish men over 60~     years through a screening program in Primary Health Care using a hand-held ultrasound and to~     analyze the relationship between cardiovascular risk factors and cardiovascular disease in~     patients with AAA.~   "
128716|NCT01882621|"~     Evaluate the efficacy and safety of Monosialoganglioside(GM1) to prevent the neurotoxicity~     induced by cisplatin~   "
128717|NCT01882608|"~     Mood disorders -- major depression, bipolar disorder, and dysthymia -- frequently recur; they~     affect one in four people during their lives. At Sunnybrook, 75% of inpatient admissions are~     due to mood disorders. Mental health telemetry (MHT) lets patients in the community use cell~     phones to track the severity of their mood symptoms over time, and enables clinicians to view~     these symptom ratings in real-time. Evidence suggests that MHT is better for detecting~     exacerbations of illness earlier than standard clinical practice alone. In this study, we~     will assess if MHT can reduce re-hospitalization rates in previously-hospitalized patients~     with mood disorders.~   "
128718|NCT01882595|"~     To compare lung deposition of amikacin in two settings: spontaneously breathing through a~     tracheostomy cannula and through the mouth.~   "
128719|NCT01882582|"~     The purpose of this study is to better understand whether and to what extent the activity of~     immune cells in blood varies over time under normal conditions as assessed in healthy~     subjects. Results of this study will provide the foundation for helping us evaluate changes~     in immune cell activities in response to surgery and drugs used in anesthesia. The overall~     purpose of our research is to understand immune health in the context of anesthesia and~     surgery.~   "
128720|NCT01882569|"~     Surgical trauma triggers a massive inflammatory response. Over time, both the innate and~     adaptive branches of the immune system are affected by surgical trauma. The purpose of this~     study is to use a single cell flow cytometry approach to characterize the cellular and~     molecular mechanisms involved in the inflammatory response to surgical trauma.~   "
134433|NCT01807676|"~     No prospective randomized clinical trial assessed the performance of this new device in a~     clinical setting. Consequently the aim of this study is to determine clinical performance of~     this new device compared with conventional DLT.~        -  Trial with medical device~   "
128721|NCT01882556|"~     Patients who survive a stroke are often left with an arm that cannot be used. One reason for~     this is that the muscles affected by the stroke become overactive. This is known as~     spasticity. Such unwanted muscle overactivity, if left untreated or poorly managed, can lead~     to limb deformities. For example, the wrist and fingers in the arm affected by spasticity~     become stiff and curl into a fist and the hand cannot be used for any functional purpose.~     Palm hygiene can become difficult and patients find this deformity unsightly and painful.~     Botulinum toxin (BT) has been shown to reduce muscle overactivity and is licensed for this~     purpose. In current practice this treatment is often used as a last line of defence. Although~     BT can reduce the muscle overactivity, when injected using current protocols, it seems to~     have little impact on the recovery of function and/or treating the limb deformities and pain.~     If BT can be given in the early stages of a stroke, i.e. as soon as the muscle overactivity~     is observed, then we will be able to treat spasticity and may prevent the limb deformities~     and pain from developing. We may also be able to assist the recovery of arm movement in some~     of the patients who would otherwise not have regained this. In addition to benefiting the~     patient, the prevention of secondary complications by early treatment may reduce the costs of~     long term care to the NHS . We hope to discover if our plan of providing early treatment with~     BT is more effective than the current approach. If we demonstrate that the treatment is~     effective we will be able to introduce this new method almost immediately within the NHS~     through our collaboration with doctors and therapists who are actively treating patients with~     this condition.~   "
128722|NCT01882543|"~     The primary objective of this study is to evaluate the effect of 6 weeks of treatment with~     once daily administration of AQX-1125 compared to placebo on average daily pain in subjects~     with interstitial cystitis/bladder pain syndrome (IC/BPS), during and after treatment, using~     a standardized 11-point numerical rating scale (NRS) pain score recorded by electronic diary~   "
128723|NCT01882530|"~     The combination of different analgesic drugs and/or analgesia techniques is part of the~     standard management of postoperative analgesia. The analysis of the literature reveals a lack~     of comparison of the associations of non-opioid analgesic (NOA) with morphine for~     postoperative analgesia.~      The objectives of this study are :~        -  comparing the morphine sparing effect of different combination of 3 NOA (paracetamol,~          nefopam, ketoprofen) for postoperative analgesia.~        -  determining whether the morphine-sparing effect is associated with or without a~          reduction in the incidence of morphine side effects.~        -  evaluating the effects of NOA on postoperative hyperalgesia.~   "
128724|NCT01882517|"~     To determine the effect of investigational products on serum LDL cholesterol.~   "
128725|NCT01882504|"~     The study will evaluate the safety and biologic activity of gevokizumab in subjects in the~     acute inflammatory phase of pyoderma gangrenosum.~   "
128726|NCT01882491|"~     The purpose of this proof-of-concept study is to determine whether gevokizumab is effective~     in the treatment of inflammatory erosive osteoarthritis of the hand.~   "
128727|NCT01882478|"~     The purpose of this study is to determine whether cryotherapy is effective in the treatment~     of persistent high grade dysplasia (HGD) or early esophageal adenocarcinoma (IMCA) in~     patients who have not responded to radiofrequency ablation (RFA).~   "
128728|NCT01882465|"~     Limbal ring contact lenses enhance the look of the eye by adding pigmentation in a ring~     pattern to the contact lens. The purpose of this investigation is to determine if corneal~     staining increase is dependent upon the lens pigment location.~   "
128729|NCT01882452|"~     Depression involves the tendency to recall overgeneral personal memories, a phenomenon which~     has been linked to numerous adverse psychological outcomes. The purpose of this study is to~     investigate whether a group-based Memory Specificity Training (MEST) programme improves~     outcomes in depression, and how this compares to an education and support control group. The~     primary aim is to examine whether MEST, which involves repeated practice retrieving specific~     autobiographical memories reduces depressive symptoms immediately post-treatment, and whether~     this is maintained 3 months after treatment. The secondary objective of this trial is to~     examine the role of hypothesised cognitive processes (ie., rumination, executive control,~     cognitive avoidance) which may underlie improvements in depression and memory.~   "
128730|NCT01882439|"~     To examine the safety and efficacy of tofacitinib in subjects with active psoriatic arthritis~     who have previously had an inadequate response to at least one TNF inhibitor either due to~     lack of efficacy or an adverse event.~   "
128731|NCT01882426|"~     Assess if standardized care-path that features objective evaluations of disease activity and~     time-bound algorithms is superior to usual step-care in the treatment of ulcerative colitis.~   "
128732|NCT01882413|"~     This study will evaluate the prevalence of inflammatory dry eye disease in patients prior to~     cataract surgery. No treatment is administered in this study.~   "
128733|NCT01882400|"~     By supplying an adequate amount of calcium and vitamin D with the addition of weekly~     bisphosphonate, the investigators will be able to increase bone mass and decrease the~     incidence of fragility fractures in these children with muscular dystrophy.~      The investigators think this treatment will also decrease the intensity of pain frequently~     present in these patients and slow the progression of scoliosis.~   "
128734|NCT01882387|"~     The purpose of this study is to evaluate the efficacy of TXA127 to reduce the incidence~     (Grade II-IV) of acute Graft-vs.-Host Disease (aGVHD) in adult subjects undergoing allogeneic~     peripheral blood stem cell transplantation (PBSCT). The study will also evaluate the effects~     of TXA127 on incidence, severity and duration of mucositis; neutrophil engraftment and~     platelet recovery; platelet transfusion requirements; immune reconstitution; and duration of~     corticosteroid use. TXA127 has shown to be well tolerated by patients and appears to induce~     rapid production of neutrophils and platelets in the bloodstream, as well as increase the~     immune system components. TXA127 has also been shown reduce the severity of~     chemotherapy-induced mucositis.~   "
128736|NCT01882361|"~     To address the question of the comparison of two courses of Vivitrol with differing lengths~     in 130 HIV negative, consenting, opioid addicted patients who have completed inpatient~     treatment. Participants will be randomized under double blind conditions to a 24 or 48-week~     course of pharmacotherapy, along with bi-weekly drug counselling, over 48 weeks, with~     follow-ups at weeks 60 and 72. The 24-week cohort will receive Vivitrol placebo injections in~     weeks 24 to 48.~   "
128741|NCT01882283|"~     A diet-controlled clinical trial which attempts to provide estimates of the effect of black~     tea consumption on serum lipids under tightly controlled conditions, including a controlled~     diet. Mildly hypercholesterolemic individuals (total cholesterol levels between 4.9 and 6.7~     mmol/L, 190 and 260 mg/dl), non-smoking, chronic disease-free individuals were enrolled in a~     15-week, double blind, randomized crossover trial, during which they consumed a controlled~     low-flavonoid diet plus 5 cups of black tea or a tea-like placebo over two 4-week treatment~     periods.~   "
128742|NCT01882270|"~     The purpose of this research study is to find out if the infection around 3rd molars and the~     resulting inflammation around the gum also produces a general systemic inflammation.~   "
128743|NCT01882257|"~     -  Patients with spinal cord injury (SCI) usually breathe without any mechanical~          assistance, but significant breathing problems occur often during sleep, either because~          the upper airway closes (obstructive sleep apnea; OSA), or because of weakness/paralysis~          of the breathing muscles. These problems often go unrecognized, as SCI patients face~          logistical barriers that cause them to refuse appropriate testing in sleep laboratories.~          We have devised a strategy for diagnosing sleep-disordered breathing in the patient's~          home, using placement of noninvasive devices that monitor breathing overnight. This~          project is designed to test the feasibility and utility of this strategy.~        -  After collecting baseline data on symptoms and medical events for four months, the~          home-based studies are performed noninvasively with FDA-approved devices: a type III~          sleep system and a recording oxygen saturation/ transcutaneous carbon dioxide monitor.~          If these studies identify sleep-disordered breathing, noninvasive ventilatory support is~          prescribed according to standard clinical practice. Over the following twelve months,~          the subjects monitor their symptoms daily, and answer quality-of-life questionnaires~          every three months. After 3, 6, and 12 months, blood tests are performed to measure~          blood sugar and cholesterol/lipids. Data is downloaded from the ventilator device to~          monitor compliance and ventilator performance. This study is designed to determine the~          prevalence of sleep-disordered breathing in SCI, the feasibility of home-based testing~          to establish the diagnosis, and the short term effects on symptoms, quality-of-life, and~          associated conditions (glucose intolerance, blood lipid disorders).~   "
128744|NCT01882244|"~     Injury to the brain can change the core of a person's being, affecting brain functions~     necessary to accomplish important goals in a complex world. Deficits in attention, working~     memory, and other aspects of goal-directed cognition affect a broad range of pursuits in~     everyday life, and are among the most prevalent and long-lasting consequences of brain~     injuries. The objective of this research is to develop remotely deployed training tools that~     target the most common, persistent and debilitating cognitive functions affected by traumatic~     brain injury (TBI); test the potential effects of the intervention and compare these effects~     to an active comparison intervention; and determine the neurocognitive and functional effects~     of computer-assisted remote training.~   "
128745|NCT01882231|"~     The objective of these studies is to use changes in 3 Tesla MRI measurements of tumor protein~     content, cell density, and microvessel perfusion, obtained before and after a single cycle of~     NAC, to predict eventual tumor response observed at the conclusion of NAC, within patients~     with osteosarcoma or Ewing Sarcoma.~   "
128746|NCT01882218|"~     The purpose of this study is to find out if direct peritoneal resuscitation (DPR) (putting a~     sugar solution into the abdominal cavity) helps blood flow through vital organs in the body~     that may suffer from low blood flow due to surgery. We will also try to find out if the DPR~     will help patients recover faster from liver surgery. Lastly, this study will also try to~     find if direct peritoneal resuscitation decreases levels of signaling chemicals in the blood~     called 'cytokines' and a protein called high-mobility group protein 1, which is known to~     cause tissue damage.~   "
128747|NCT01882205|"~     The risk for colon cancer in patients with longstanding ulcerative colitis exceeding the~     rectum is increased and therefore patients should be enrolled in a surveillance program eight~     years after the diagnosis. Until today, official international guidelines for endoscopic~     screening in patients with ulcerative colitis advise to take 4 biopsies every 10 centimeters~     (with a minimum of 32) and of each suspected visible lesion. These guidelines are merely~     based on consensus during expert opinion meetings rather than evidence based. Recent studies~     have shown that chromo-endoscopy guided biopsies significantly reduced the number of biopsies~     for each procedure and detected more neoplastic lesions. Chromo-endoscopy is therefore~     considered the gold standard in this study in which we want to compare it to the performance~     and efficiency of new endoscopic imaging techniques.~      Narrow-Band Imaging (NBI) selectively uses certain wavelengths of the visible light leading~     to a shift in the excitation spectrum towards blue light. The first studies with NBI showed~     that the additional value of NBI in the detection of neoplastic lesions is comparable to~     chromo-endoscopy, but time saving and easier to perform. The Fujinon Intelligent~     Chromo-Endoscopy (FICE) system uses a similar theoretical principal as NBI but this is~     achieved via the use of post hoc computer algorithms, applying different filters to the~     stored endoscopic images and enabling a theoretically endless number of combinations of~     filters that can be used. The Pentax I-scan system also allows post hoc modification of the~     images. On the one hand, surface enhancement enables to better highlight mucosal changes.~     Spectral modification allows to apply different modes in analogy with to FICE system.~      These new imaging techniques have a theoretical advantage which is extendedly used for sales~     purposes but has however so far not been proven in ulcerative colitis patients. We want to~     test their clinical use in the screening for neoplastic lesions in patients with long~     standing ulcerative colitis.~   "
128748|NCT01882192|"~     The primary research question is:~      1) Does the planning condition improve adherence to regular physical activity compared to the~     control condition at six months? Hypothesis: Adherence will be higher for the planning~     condition in comparison to the more standard physical activity education condition. The~     effect may wane over time from the initial measurement period but all outcomes will remain~     significantly higher at six months.~      Secondary Research Questions~        1. Does the planning condition improve motivational, health-related quality of life, and~          health-related fitness outcomes compared to the control condition at six months?~           Hypothesis: The planning condition will not affect intentions or underlying motives~          (theory of planned behaviour constructs) for physical activity because its effect on~          behavior is to tie initial intentions better to behavioural action (i.e., behavioural~          regulation) and not to enhance motivation. Health-related fitness and quality of life,~          however, will be higher for the planning condition in comparison to the standard~          physical activity education intervention condition. The effect may wane over time from~          the initial measurement period but all outcomes will remain significantly higher at six~          months in the planning condition compared to the standard physical activity education~          group.~        2. Can group differences among these motivational, behavioural, and health-related fitness~          outcomes be explained through a mediation model? Hypothesis: The covariance of the~          assigned conditions (planning, education) on use/adherence will be explained by planning~          and use of behavioural regulation strategies (i.e., manipulation check). In turn, the~          covariance between planning and behavioural regulation strategies and health-related~          outcomes will be explained by physical activity adherence among conditions.~        3. Can motivational variables predict adherence? Do these differ by condition?~           Hypothesis: The approach will test Ajzen's theory of planned behavior, extended by the~          concept of active planning. Affective attitude and perceived behavioural control will~          predict intention, intention will predict planning and planning will predict adherence~          across conditions.~        4. Is there an intergenerational, seasonal, or gender difference across primary outcomes by~          assigned condition? Hypothesis: Children will show greater adherence to the planning~          condition than their parents. No differences in gender or season are hypothesized but~          these are exploratory research questions because there is limited research at present to~          make any definitive statement.~   "
128893|NCT01880307|"~     The purpose of this study is to determine whether a top-down treatment approach, prescribing~     infliximab and azathioprine at diagnose, yields better outcome in comparison to the usual~     step-up treatment approach, starting with prednison and azathioprine, in moderate-to-severe~     pediatric Crohn's disease (CD) patients.~   "
128749|NCT01882179|"~     Heart attacks, or myocardial infarcts, are a major cause of death and disability in the UK.~     Immediate unblocking of the obstructed heart vessel with a balloon catheter and implantation~     of a mesh scaffold (stent) in heart centers is warranted in these patients. Morbidity and~     mortality in this patient group is related to the infarct size. Therefore, there is a need to~     discover novel therapeutic agents which reduce myocardial infarct size and preserve the~     contractile heart function.~      Large trials involving several thousand patients have demonstrated a survival benefit in~     patients with impaired heart function due to a heart attack, who received a~     mineralo-corticoid receptor antagonist (MRA, drug name: spironolactone). In these trials~     patients received the drug late, 3-14 days after the heart attack.~      Our proposal is to investigate whether MRA therapy administered intravenously prior to~     unblocking an occluded heart vessel, can reduce infarct size and as such can prevent long~     term sequelae of heart attacks.~      150 patients admitted to 4 tertiary care hospitals (Heart Hospital London, London Chest,~     Essex Cardiothoracic Center and Leeds General Infirmary) for heart attack will be randomly~     assigned to receive MRA treatment or placebo. The first dose of the MRA will be applied~     intravenously immediately in the catheter suite, even before re-opening of the occluded~     vessel. From the second day on, patients will be prescribed oral MRA treatment, as a pill,~     for a total of three months. Before hospital discharge and after three months, a magnetic~     resonance image (MRI) of the heart will accurately investigate the evolution of infarct~     (scar) size and the contractile heart function and compare the group of patients who received~     the MRA drug versus the placebo control group. Of note, patients with an ejection fraction~     <40% AND signs of heart failure OR diabetes will go on open label eplerenone according to~     current guidelines, instead of the study drug.~      This study will give first evidence, if very early MRA treatment improves heart function and~     should be used as early as possible for treatment of patients after a heart attack.~   "
128750|NCT01882166|"~     The number of children conceived by assisted reproductive technology is increasing in Nordic~     countries as well as worldwide. An important factor of success in treatment of infertility is~     a short time to pregnancy with impact on both economical aspects for the society and~     medical and psychological aspects for the couple. During treatment, success relies on 1)~     optimal stimulation of growth and maturation of multiple follicles by administration of~     exogenous follicle stimulating hormone (FSH), and 2) selection of the fertilized egg / embryo~     with the highest potential of implantation to be transferred to the mother. In the present~     project stimulation of egg production by human urine derived FSH (Fostimon®) and recombinant~     FSH (Puregon®) will be compared. To this end early embryo development and kinetics after~     fertilization will be evaluated. The system to be used is time-lapse recording of embryo~     morphology during the first days of embryo development by means of an embryoscope. Aim of~     this study is to investigate if Puregon and urinary Fostimon have different effect on embryo~     quality. The hypothesis of the study is that stimulation of egg production by these two types~     of follicle stimulating hormone does not have the same effect on early embryo quality.~   "
128751|NCT01882153|"~     The investigators will assess the efficacy of parent delivered interventions in the treatment~     of social and communication deficits in children with autism. By collecting information about~     parent and child functioning before and after intervention, the investigators will be able to~     determine whether the intervention is effective in improving child social communication and~     reducing parent stress.~   "
128752|NCT01882140|"~     The high incidence of burn injuries and mortality and morbidity as well as the high economic~     impact associated with this type of injury justifying the need to develop new technologies~     for the treatment of burn patients. Electrical stimulation for wound healing is a resource~     that has been increasingly used in routine physical therapists, but has the disadvantage of~     needing means of wet contact between the electrode and injury. The other resource used for~     therapeutic healing is conventional electrical stimulation of low intensity for capacitive~     field, a technique of physical therapy intervention not commercially available in Brazil.~     This new technology seems to have significant physiological effects in tissue repair and has~     been used for the treatment of chronic wounds which healed with difficulty. The objective is~     to analyze the effects of electrical stimulation of low intensity for capacitive field in~     healing skin burns. Patients from both genders aged over 18 years who have burns, will be~     evaluated and treated at the Emergency Unit of the Hospital of the Faculty of Medicine of~     Ribeirão Preto, University of São Paulo. The stimulation will be initiated within 24 hours~     after surgery to perform the graft and will be held daily for 60 minutes during the patient's~     stay or until complete healing of the skin. The electromagnetic field will be placed on the~     care of the burned area and / or the donor skin graft, not interfering with departmental~     procedures. Will be performed photographic record standardized wound by a digital camera, and~     then quantified by a computer program. Expected to reduce the period of hospitalization and~     thus lowering the cost of treatment, and the possibility of improving the quality of life of~     patients.~   "
128753|NCT01882127|"~     The project was undertaking by Qilu Hospital of Shandong University in China. In order to~     report the efficacy and safety of All-Trans Retinoic Acid (ATRA) combining with High-dose~     Dexamethasone for the treatment of adults with primary immune thrombocytopenia (ITP),~     compared to conventional high-dose dexamethasone therapy.~   "
128754|NCT01882114|"~     The prevalence of metabolic syndrome in patients suffering from non valvular atrial~     fibrillation is derived from studies regarding recurrences of atrial fibrillation after~     catheter ablation. Prospective studies in european countries are lacking. Furthermore, the~     impact of metabolic syndrome on cardiovascular events in patients with non valvular atrial~     fibrillation is still unknown.~   "
128755|NCT01882101|"~     Until recently, there is no definite treatment for fecal incontinence that is proven to be~     effective with low morbidity. The efficacy of biofeedback therapy for incontinence has not~     been proven on the randomized controlled trials. Sacral nerve stimulation is too expensive~     although some prospective studies showed the therapeutic potential. Recently, posterior~     tibial nerve stimulation has been reported to be effective with lower cost in comparison with~     sacral nerve stimulation. This study is designed to show the efficacy of posterior tibial~     nerve stimulation compared with biofeedback therapy for fecal incontinence.~   "
128766|NCT01881958|"~     Type 1 diabetes is caused by an autoimmune process resulting in a selective destruction of~     the pancreatic insulin-secreting beta-cell. DiaPep277® is a small, lyophilized powder~     containing 24 Amino-acids. We have proved in former studies that DiaPep277® can slow down~     beta cells destruction in the pancreas and therefore decelerate the progress of Diabetes.~      The objective of the study is to assess the efficacy and safety of administrating DiaPep277®~     in type 1 diabetes patients.~   "
128767|NCT01881945|"~     The aim of the study was to validate tools of physiological signal processing and~     interpretation on healthy human volunteers in order to improve the understanding in~     respiratory physiology and its interactions with heart function, and swallowing.~   "
128756|NCT01882088|"~     Gastroesophageal reflux disease (GERD) is a chronic condition, which may significantly~     decrease patients' quality of life due to the typical symptoms - heartburn and regurgitation.~     These are caused by increasing number of transient lower esophageal sphincter relaxations,~     regularly recurring reflux of gastric content into oesophagus, acidification of the esophagus~     and consequent esophageal mucosa damage. In addition, an important role is played by the~     increase in production of hydrochloric acid in the stomach, the slowdown in the evacuation of~     the contents from the stomach and increase of gastric and intra-abdominal pressure. All of~     these factors may depend on the patient's diet.~      Theoretical premises of the positive influence of including dietary fiber on the course of~     gastroesophageal reflux disease may be the fact that dietary fiber may absorb nitric oxide~     (NO) containing in food, which in turn has relaxing effects on the lower esophageal~     sphincter. In addition, fiber deficiency has been shown to be associated with increased~     chance of developing hiatal hernia, which is associated with greater risk of the disease~     manifestations. There is lack of data about diet modification with its enreaching by dietary~     fibers and their type on the symptoms frequency and objective (i.e. esophageal pH-impedance~     and manometric) parameters.~      Mucofalk® is a drug of plant origin, consisting of a shell seeds of Plantago ovata~     (isphagula, psyllium). High content of mucuses in the composition of psyllium seed allows it~     to include to group of soft food fibers, which has fundamental value for the appointment of a~     drug at a number of diseases, when, for example, the use of coarse food fibres not~     recommended or contraindicated.~      Mucofalk is the registered medicinal (registration number of the Russian State register of~     medicines P N014176/01, registration date 14.07.2008, manufacturer: Lozan Pharma GmbH,~     packager: Dr. Falk Pharma GmbH, Germany). Recommended dosage and administration: orally,~     adults and children over 12 years - 1 pack. 2-6 times a day. Before use, the contents of 1~     packet poured in a glass, in which slowly poured with cold water (150 ml), stir and drink~     immediately. Then drink another glass of liquid.~   "
128757|NCT01882075|"~     The investigators want to test during anesthesia the feasibility of a closed-loop automated~     fluid replacement system using cardiac output monitoring as the input value.~   "
128758|NCT01882062|"~     The purpose of this project is to study the efficacy of an anaplerotic treatment on brain~     energy profile evolution at an early stage of the Huntington disease.~   "
128759|NCT01882049|"~     This study is to investigate the use the adjustable gastric band for the treatment of obesity~     in adolescents.~   "
128760|NCT01882036|"~     The focus of this proposal is to define the mechanism by which bariatric surgery acutely~     improves insulin sensitivity. Our central hypothesis is that drastically reduced caloric~     intake early after Bariatric surgery improves the pro-inflammatory profile of macrophages,~     which in turn improves insulin sensitivity and glucose homeostasis.~   "
128761|NCT01882023|"~     Currently, there is not a robust, testable neural model available that sufficiently explains~     the development and maintenance of anorexia nervosa (AN) a severe, often fatal,~     adolescent-onset eating disorder. Using state of the art neuroimaging and neuropsychological~     techniques, our objective is to identify neural mechanisms in the adolescent brain underlying~     AN. This is of high clinical relevance in as much as it will provide a robust platform for a~     diagnostic battery so that physicians can identify those who are prone to develop AN at a~     very early stage of life.~      The aim of this research plan is: 1) To develop knowledge of cognitive dysfunction in~     adolescents who have recently been diagnosed with AN, with a battery of cognitive tests~     during a series of clinical visits. 2) To provide a scientific basis for our knowledge about~     how the brain of an adolescent with an eating disorder differs from that of a healthy~     adolescent, by conducting functional and structural magnetic resonance imaging on adolescent~     females with AN.~   "
128762|NCT01882010|"~     The purpose of this study is to determine if Leukine (sargramostim) can be safely~     administered to Parkinson's disease patients for an extended period of time (56 days) and~     restore immune deficits seen in Parkinson's patients compared to controls. The development of~     magnetoencephalography (MEG) as a monitoring tool for PD will also be explored. At enrollment~     and repeating again at two 4-week intervals, whole blood from PD patients and controls will~     be obtained for analyses and the results will be used to calculate immune response profiles~     as a baseline for comparison after drug treatment. Physical examinations and motor~     assessments will also be performed on PD patients. After the 8-week baseline data collection,~     control participation will end and drug treatment of PD patients will begin. PD patients will~     be randomized, and half will receive drug and half will receive placebo. Leukine at a dosage~     of 6 µg/kg or saline as placebo will be administered by subcutaneous injection daily for 56~     days (8 weeks). During drug treatment, PD patients will be monitored every two weeks by~     physical examinations, motor assessments, and blood analyses. As follow-up, four weeks after~     drug administration has stopped, subjects will again have physical examinations, motor~     assessments, and blood analyses. MEG will be performed on PD patients and controls at the~     start of drug treatment, and on PD patients at the end of the drug treatment period and 4~     weeks after drug is stopped. In addtion, at the second cohort of 8 PD subjects, we will~     evaluate the potential Leukine-induced motor control and mobility improvements. Also, levels~     of the neurotransmitters glutamate, glutamine, serotonin, acetylcholine, GABA, norepinephrine~     and epinephrine in serum/plasma will be analyzed to correlate with changes in motor function~     and drug treatment.~   "
128763|NCT01881997|"~     Patients presenting with painful procedures in the Emergency Department (ED) have been shown~     to frequently have inadequate pain management. The incision and drainage (I&D) of an abscess~     is a common procedure that is viewed by many emergency physicians as only requiring a~     localized anesthetic for pain management. However, it has been documented in previous~     research that there can be disconnect between what emergency medicine physicians interpret as~     painful and what patients experience as pain. A trial will be conducted to focus on use of~     intramuscular (IM) Fentanyl as an intervention to help alleviate pain associated with the~     incision and drainage of an abscess. This is a procedure that rarely receives systemic~     opioids.~      This double blinded protocol will randomize a total of 50 patients patients with abscesses to~     receive either a combination of Fentanyl IM followed by subcutaneous (SC) local bupivicaine~     analgesia or Normal Saline IM followed by SC local bupivicaine analgesia. Only opiate naive~     patients will be enrolled. The primary outcomes studied are patients overall satisfaction~     with procedure, and patients level of pain associated with the procedure.~   "
128764|NCT01881984|"~     This is a medical research study to test a medication in adult patients with a disease called~     medium-chain acyl-CoA dehydrogenase (MCAD) deficiency caused by at least one copy of the~     985A>G mutation. The medication is glycerol phenylbutyrate, called Ravicti, which is~     currently FDA approved for the treatment of urea cycle disorders. Previous research suggests~     that Ravicti may also be effective in the treatment MCAD deficiency. This study will~     investigate the safety and efficacy (how well it works) of Ravicti in patients with MCAD~     deficiency caused by having at least one copy of the 985A>G mutation.~   "
128765|NCT01881971|"~     Hypothesis: Statin therapy will decrease inflammation and slow progression of cardiopulmonary~     abnormalities in HIV.~   "
128770|NCT01881906|"~     The aim of this study is to evaluate the effect of twelve weeks of a physical and~     psycho-social program consisting of: supervised, structured exercise training in a group of~     advanced lung cancer patients (cardio and strength training, relaxation training) twice~     weekly. Primary outcome is (VO2peak). The hypotheses are that patients who undergo this~     intervention will increase maximal oxygen uptake (VO2peak), strength (1RM), functional~     capacity (6MWD) and quality of life (HRQOL) and reduce the level of anxiety and depression~     compared to those who do not.~   "
128771|NCT01881893|"~     The psychosocial development of adults with congenital heart disease (CHD) can be challenged~     by many issues including family overprotection, impaired peer relationships, delayed~     progression into independent adulthood, and difficulties with career and future planning.~     One-third of patients have diagnosable mood or anxiety disorders and the prevalence of~     depression is 3 times that of the general Canadian population. Unfortunately, most adults~     with CHD and significant depression or anxiety do not receive mental health treatment.~     Despite an increasing awareness of the unique psychosocial concerns of this patient~     population by both health care providers and patients, there have been no interventions~     targeting psychosocial outcomes in the adult CHD population. Our quantitative and qualitative~     research suggests that patients themselves are very interested in psychological services that~     target their distinctive life experiences, are provided in a group setting, and emphasize~     coping and resilience. The overarching aim of this proposal is to assess the feasibility of a~     full-scale randomized controlled trial of a group intervention aimed at improving the~     psychosocial functioning, quality of life, and resilience of adults with CHD.~   "
128772|NCT01881880|"~     Study Rationale: an accurate breast cancer staging has a great impact in the management of a~     breast cancer. MRI is considered as the most sensible exam for this staging. However it has a~     low specificity and it may result in extra testing and stress for the patient, add to costs,~     and delay treatment. By contrast, Tomosynthesis is performed during the same time than~     mammography and has a good specificity. Although this modality is very promising, it has not~     been assessed in a population of consecutive patients.~      Study objectives: To compare the diagnostic performance of preoperative bilateral Combo mode~     (MG+Tomosynthesis) versus mammography among women with breast cancer for the detection of~     additional multifocal, multicentric, and contralateral cancers.~   "
128773|NCT01881867|"~     This randomized phase II trial studies how well glycosylated recombinant human interleukin-7~     (CYT107) after vaccine therapy works in treating patients with castration-resistant prostate~     cancer that has spread to other areas of the body or has not responded to at least one type~     of treatment. Biological therapies, such as glycosylated recombinant human interleukin-7, may~     stimulate the immune system in different ways and stop tumor cells from growing. Vaccines~     made from white blood cells mixed with tumor proteins may help the body build an effective~     immune response to kill tumor cells. It is not yet known whether glycosylated recombinant~     human interleukin-7 works better with or without vaccine therapy in treating prostate cancer.~   "
128774|NCT01881854|"~     The hypothalamus is a part of the brain containing a number of nuclei with a variety of~     functions. It is central in the regulation of hormone secretion, sleep, and circadian~     functions. The suprachiasmatic nucleus of the hypothalamus is a key component in controlling~     circadian rhythms and generates the rhythm of melatonin secretion from the pineal gland and~     cortisol secretion. Both melatonin and cortisol are involved in the regulation of circadian~     rhythms and sleep.~      Craniopharyngiomas are a type of brain tumors that usually affect the hypothalamus~     indirectly. In general, they are locally aggressive invading crucial structures e.g. the~     hypothalamus, the pituitary, and the optic nerve. Compared to healthy controls,~     craniopharyngioma patients have previously been reported with impaired quality of life,~     increased self-reported general and physical fatigue, increased daytime sleepiness, and~     increased prevalence of severe sleepiness~      Damage to the hypothalamus by local tumour or its treatment might involve the suprachiasmatic~     nucleus and thereby melatonin secretion leading to disturbed circadian function causing~     clinical manifestations in terms of daytime sleepiness and fatigue.~      The investigators aimed to assess the influence of craniopharyngiomas or their treatment on~     melatonin secretion, and the association with sleep pattern, sleep quality, fatigue, and~     sleepiness.~      15 patients with craniopharyngioma and 15 gender, age, and BMI matched healthy controls were~     included. Salivary melatonin and cortisol were measured over a 24h-period. Sleep-wake~     patterns were characterized by two weeks of actigraphy recordings and sleep diaries.~     Sleepiness, fatigue, sleep quality, and general health were assessed by questionnaires.~   "
128775|NCT01881841|"~     The goal of this project is to evaluate the feasibility, acceptability, and effect size of a~     new computerized Motivational Enhancement Therapy (cMET) intervention for alcohol-involved~     adolescents in primary care.~   "
128776|NCT01881828|"~     The objective of the proposed research is to evaluate the efficacy and safety of the use of~     metformin in addition to standard insulin therapy in overweight and obese children and~     adolescents, age 12-<20 years, with type 1 diabetes for at least 1 year. Secondary objectives~     are to assess the effect of metformin on C-peptide levels, a measure of how much insulin is~     still being produced by the beta cells of the pancreas, and on vascular dysfunction. In~     addition, an ancillary study is planned to assess if metformin will improve tissue-specific~     insulin resistance in type 1 diabetes using a hyperinsulinemic euglycemic clamp.~   "
128777|NCT01881815|"~     The objective of this study is to collect wound exudate (fluid) swab samples from Subjects~     who have wounds that show clinical signs of infection, as well as from Subjects who have~     wounds that do not show clinical signs of infection. Swab samples will be collected from~     acute and chronic wounds of different etiologies and these will be analysed for bacteria~     types and markers of infection.~   "
128778|NCT01881802|"~     This trial aims to investigate the effects of opioid-inducing immune suppression on opioid~     drug abused patients. The methods of the investigators research mainly includes the~     expression of morphine-related miRNAs in peripheral blood mononuclear cells and cytokine in~     plasma.~   "
128792|NCT01881620|"~     Hypothesis:~      The investigators would like to demonstrate that diagnosis performance of PET/CT scan without~     and with contrast agent (COMBI TEP), are equivalent or better than those of PET/ non enhanced~     CT scan (PET scan) associated with an enhanced CT scan. This research project is a pilot~     study given the few available data concerning this imaging exam reproducibility.~      This study is a prospective single center study.~   "
128779|NCT01881789|"~     Phase 1b:~        -  To establish the maximum tolerated dose (MTD) of oprozomib and dexamethasone~          administered in combination with lenalidomide or oral cyclophosphamide~        -  To evaluate the safety and tolerability of oprozomib and dexamethasone administered in~          combination with lenalidomide or oral cyclophosphamide~      Phase 2:~        -  To estimate the overall response rate (ORR) and complete response rate (CRR)~        -  To evaluate the safety and tolerability of oprozomib and dexamethasone administered in~          combination with lenalidomide or oral cyclophosphamide~      Secondary Objectives:~        -  To evaluate population pharmacokinetic (PK) parameter estimates of oprozomib and~          variability in these estimates when administered in combination with dexamethasone and~          lenalidomide or oral cyclophosphamide~        -  To estimate the duration of response (DOR)~        -  To estimate progression-free survival (PFS)~   "
128780|NCT01881776|"~     The investigators undertook this prospective, randomized trial to compare the recovery~     profile throughout the first postoperative week in patients receiving continuous (CISB)~     interscalene brachial plexus block, single injection (SISB), or general anesthesia (GA) for~     arthroscopic rotator cuff repair surgery. Specifically, the effects of the three anesthetic~     techniques when used intraoperatively as a sole anesthesia modality were studied on~     postoperative pain, time-to-first pain, analgesic consumption, fast-tracked PACU bypass rate,~     length of PACU stay, time-to-discharge home, sleep duration, and related adverse effects. The~     investigators hypothesized that CISB results in a superior postoperative recovery profile as~     compared to SISB or GA alone.~   "
128781|NCT01881763|"~     The study aims to compare outcomes of Electroconvulsive Therapy (ECT) using ketamine versus~     methohexital anesthesia in depressed patients. The investigators hypothesize that patients~     who receive ketamine anesthesia during ECT will achieve remission status faster than those~     receiving methohexital anesthesia. Also, at the end of the ECT course subjects will display~     fewer cognitive side effects compared to those treated with methohexital anesthesia.~   "
128782|NCT01881750|"~     This is a research study examining the effectiveness of pivotal response treatment group~     (PRTG) in targeting language skills in young children with autism. Research has demonstrated~     that behavioral interventions, such as Pivotal Response Training (PRT), lead to improvements~     in the core symptoms of autism. The purpose of this study is to further examine the~     effectiveness of teaching pivotal response treatment to parents of children with autism in a~     group format. To determine the effectiveness of pivotal response training group (PRTG) it~     will be compared to another parent education group by conducting a randomized controlled~     12-week trial.~   "
128783|NCT01881737|"~     This study will assess the tolerability and effectiveness of pregnenolone in the treatment of~     behavioral deficits in adults with autism. Pregnenolone is a naturally occurring hormone~     found in the body which has been shown to help with the function of nerve cells. It is also~     shown to modulate the activity of certain brain receptors implicated in autism. We hope to~     examine the tolerability of pregnenolone in adults with autism.~   "
128784|NCT01881724|"~     This is a randomized controlled trial with 12 month sleep education as intervention, followed~     by a 12 month observational period, to study whether sleep education would improve glycemic~     control and cardiometabolic profile of sleep deprived type 2 diabetic patients and evaluate~     the neurohormonal changes associated with sleep education.~   "
128785|NCT01881711|"~     Primary objective is to demonstrate that data collected from ShuntCheck-Micro-Pumper (SCMP)~     testing results can be used in conjunction with imaging to diagnose shunt patency or~     obstruction in pediatric/adolescent subjects presenting to an Emergency Department or~     Neurosurgery Clinic (ED/NC). SCMP results and SCMP results combined with other diagnostic~     methods, including the Attending Physician's and the Neurosurgeon's clinical judgment will be~     compared to clinical outcomes within 7 days of ED/NC visit - either shunt obstruction~     confirmed during shunt revision surgery or shunt patency confirmed by no surgery or patency~     confirmed in surgery.~   "
128786|NCT01881698|"~     Establishment of a range of normal values in pregnancy with the Multiple Electrode~     Aggregometry (Multiplate@) device, a device that allows measurement of not only platelet~     count but platelet function. This has not been studied in ths special patient group. Results~     from this trial will be used as a basis for further investigation of abnormal platelet~     function in pregnancy.~   "
128787|NCT01881685|"~     The objective of the study is to evaluate the association between certain markers in the~     blood of neonatal brain injury and specific Fetal Heart Rate monitoring findings using the~     device under study.~   "
128788|NCT01881672|"~     Inhalation is a common condition in patients with impaired their awareness requiring~     protection of the upper airway by endotracheal intubation. This inhalation may lead to~     chemical pneumonitis and/or bacterial pneumonia. Only the latter requires the administration~     of antibiotics. Patients developing such a bacterial pneumonia, has a mortality, duration of~     mechanical ventilation and length of ICU stay increased. However, the proportion of patients~     with such bacterial pneumonia, bacterial ecology and morbidity that are little known.~      The aim of this study is to determine the frequency of bacterial pneumonia in patients~     admitted to the ICU for coma and treated with mechanical ventilation~   "
128789|NCT01881659|"~     HPV testing for primary cervical cancer screening of women over 30 years of age is likely to~     become the standard of care in the near future in many areas of the world. Its high~     sensitivity can significantly improve the effectiveness of screening programs and its~     prolonged negative predictive value can allow extension of screening intervals. However, a~     single HPV test has low positive predictive value and can lead to unnecessary workup and~     over-treatment and generate unnecessary distress. This multi-centric study will screen 50,000~     women with HPV testing and compare several triage approaches that can follow HPV testing in~     order to make an HPV-based screening programme efficient, affordable and sustainable.~   "
128790|NCT01881646|"~     The main purpose of this study is to assess the induction of neuroinflammation in brain~     regions of interest for learning and memory in adult patients undergoing urological surgery~     under general anesthesia~   "
128791|NCT01881633|"~     The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of~     single dosing study with three ascending dose cohorts of ISU302 in healthy subjects.~   "
128830|NCT01881126|"~     This efficacy and safety study will evaluate LUMIGAN® RC/ LUMIGAN® .01 (bimatoprost 0.01%)~     alone compared to TRAVATAN Z® (travoprost 0.004%) and TIMOLOL MALEATE-EX, 0.5%/TIMOLOL GFS~     0.5% (timolol 0.5% ophthalmic gel forming solution) in patients who require IOP lowering~     therapy.~   "
128793|NCT01881607|"~     This is a community essay to assess the effectiveness of a multi-level (individual, family,~     and school) school-based intervention to prevent the exposure to secondhand smoke (SHS) in a~     population of 1,734 schoolchildren (12-14 years old) in Terrassa (Catalonia, Spain). Schools~     were assigned to the intervention or the controlgroup at random. The investigators assessed~     SHS exposure in different settings (at school, at home, on transportation and leisure time)~     and tobacco consumption by means of a questionnaire before and one year after the~     intervention. Based on a previously evaluated intervention to prevent smoking initiation~     (PASE/ESFA program) the investigators designed a new intervention (the RESPIR•NET Program)~     including two new activities to prevent passive smoking to be applied at three levels: in the~     classroom (pupils), at the school (pupils, teachers, and parents), and in the family (pupils~     and parents).~   "
128794|NCT01881594|"~     The aim of this study is to compare postoperative ileus between stimulated and unstimulated~     patients prior to ileostomy closure.~   "
128795|NCT01881581|"~     This is a randomized, double-blind placebo-controlled dose-escalation clinical trial to~     evaluate the safety and the immunogenicity of DNA and modified vaccinia virus Ankara (MVA)~     HIV-1 vaccines in subjects receiving stable highly active antiretroviral therapy (HAART) who~     have an HIV-1 RNA < 50 copies/mm3 and CD4+ T cells count ≥ 350 cells/mm3.~   "
128796|NCT01881568|"~     The main objective is to evaluate the efficacy and safety of topical Tranexamic Acid (TA) to~     reduce the blood transfusion rate in total knee arthroplasty. The secondary endpoints are to~     estimate the visible blood loss at 24 hours after surgery, and invisible blood loss through~     serial counting of Hb/Htc. Methodology. TRANEX1 is a phase III, unicentric, controlled,~     randomized, double blind clinical trial that compare efficacy and safety of topical TA versus~     intravenous TA in a multimodal protocol, with no-inferiority criteria(n=79).~   "
128797|NCT01881555|"~     The objective of this trial is to compare the clinical outcomes and cost-effectiveness of 2~     therapeutic strategies, one based on coronary angiography guidance and the other based on~     coronary angiography with fractional flow reserve (FFR) in multivessel coronary artery~     disease patients.~      The trial is a prospective, multicenter, French, randomized clinical trial including men and~     women ≥ 18 years presenting with significant multivessel disease defined by coronary~     angiography as coronary narrowing > 50% diameter stenosis in at least 2 major epicardic~     vessels. The patients who give their informed consent will be randomly assigned to a~     therapeutic strategy based upon coronary angiography or angiography with FFR testing. In the~     FFR group, a significant coronary stenosis will be defined by a FFR ≤ 0.8. Based upon this~     multivessel evaluation (angiography or FFR), the investigator will choose the best~     therapeutic strategy to his discretion (medical optimal treatment, coronary stenting,~     coronary artery bypass graft surgery). The aim of revascularization procedures will be to~     obtain complete revascularization. In the FFR group, only stenosis with FFR≤0.8 will be~     treated.~      The primary end point of the trial is a composite of major cardiovascular events including~     death from any cause, myocardial infarction, any hospitalization for coronary~     revascularization performed in addition to initial treatment and stroke at 1 year of~     follow-up.~      Secondary end points will include adverse events, individual major cardiovascular events,~     stent thrombosis, bleeding events, occlusion of coronary artery bypass graft, patient's~     quality of life and cost-effectiveness and 30-day, 6 month, 2-year and 5-year outcomes.~   "
128798|NCT01881542|"~     Background and project rationale:~      Preeclampsia is a common complication of pregnancy, affecting 6-8% of all pregnancies and~     constitutes a leading cause of maternal morbidity and mortality. Preeclampsia is liable to~     endanger the lives of both the gravida and the fetus, particularly if treatment is initiated~     inappropriately or in an untimely fashion.~      Diagnosis of preeclampsia is dependent on the finding of proteinuria, determined as being~     over 300mg of protein in a 24 hours urine sample. However, urine collection spanning 24 hours~     sometimes constitutes a bottleneck, extending the time to diagnosis of preeclampsia.~     Additionally, the collection of urine for 24 hours entails a degree of discomfort, requiring~     that the woman be in proximity to for collection vessel, and increases the length of her~     hospital admission.~      The use of an abbreviated test may permit diagnosis and treatment in a more timely fashion.~     Similarly, the ability to exclude the diagnosis more rapidly could reduce length of hospital~     stay and consumption of the health system's limited resources. Further, a shorter test may~     reduce the discomfort associated with the 24-hour test and thus increase compliance.~      Previous research has suggested that briefer tests correlate with the traditional 24 hour~     urine collection, however these studies were based on small study populations.~      Research Objective:~      To validate a brief and rapid test for the diagnosis of urinary protein excretion.~      To assess whether, in women with suspected preeclampsia, a difference exists between protein~     excretion during the daytime and at night.~      Methods:~      Urine collection will be performed on pregnant women admitted for investigation of suspected~     preeclampsia, with volumes recorded and samples taken at 6, 12 and 24 hour intervals for~     assessment of urinary protein content. As such, a comparison will be made between the protein~     excretion after 6 and 12 hours with that over a full 24 hour period; in addition, comparison~     will be made between daytime and nighttime urinary protein excretion. The results will allow~     for assessment of whether a shorter test can substitute the full 24 hour collection in the~     diagnosis of preeclampsia; results of women who are shown to not suffer from preeclampsia~     will be used to assess whether a short test can rule out the disease. Additionally a urine~     sample for protein/creatinine ratio will be examined and correlated with results of the~     different collection periods.~   "
128799|NCT01881529|"~     To treat patients with scleroderma by blocking the expression of LOXL2. The investigators~     first need to confirm (through observation) that LOXL2 is overexpressed in disease.~   "
128800|NCT01881516|"~     we plan to conduct this trial to find out：~        -  If acpuncture treatment could relieve CRF among lung cancer patients receiving chemo- or~          radio-therapy？~        -  How about the extent it relieves？the safety and applicability ？~        -  What's the possible influential factor and mechanism ？~   "
128801|NCT01881503|"~     The purpose of this expanded access study is to be able to provide treatment with HBOC-201 to~     patients with life-threatening anemia for whom blood is not an option.~      HBOC-201 is not FDA approved for use in the United States, but is approved as an oxygen~     carrier in South Africa and Russia.~   "
128802|NCT01881490|"~     The overall objectives of this study are to develop two indices capable of measuring~     intestinal damage, and, separately, inflammatory disease activity in Pediatric Crohn's~     disease by means of Magnetic Resonance Imaging with Enterography protocol (MRE) and pelvic~     MRI.~   "
128831|NCT01881113|"~     The purpose of this study is to evaluate the onset and duration of action of AC-170 0.24%~     compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in~     the conjunctival allergen challenge (CAC) model.~   "
128832|NCT01881100|"~     It was hypothesized that resin infiltration in conjunction with fluoride varnish treatment of~     smooth-surface caries lesions in deciduous teeth reduce considerably the progression of~     treated caries lesions, compared to fluoride varnish therapy only.~   "
128833|NCT01881087|"~     The purpose of this study is to evaluate motor block probability throughout time and clinical~     profile when using three different doses of HLBP 0.75% (7.5, 9.37 and 11.25 mg) by a~     unilateral spinal block technique.~   "
128803|NCT01881477|"~     CONTEXT: The physical deconditioning in the critically ill patient is favored by prolonged~     immobilization, which compromises the ability to function. This perpetuates the stays in~     hospital and intensive care units (ICU). To combat this, there physiotherapy intervention~     methods that can reverse or reduce their occurrence.~      OBJECTIVE: The purpose of this research is to determine the effects of passive movements,~     assisted active and resisted, and changes of position on grip strength, joint mobility and~     functional capacity in patients in ICU.~      METHODS: A quasi-experimental intervention, before and after, no control group, in which 40~     patients in an adult ICU in Medellin, receive physiotherapy care. Electrogoniometry,~     dynamometry and functional independence measure, will be made before the intervention and~     serial assessments every four days, until discharge from ICU.~   "
128804|NCT01881464|"~     Study hypothesis - this study will assess the presence of endothelial dysfunction in patients~     with Crohn's disease before and after 12 weeks treatment of anti TNF α.~   "
128805|NCT01881451|"~     The purpose of this study is to use 18F-EF5 PET/CT scans to locate areas with low oxygen~     levels (hypoxia) in patients with recurrent and/or metastatic cancer.~   "
128806|NCT01881438|"~     The purpose of this study is to assess the association of retinal detachment (separation of~     the retina [the innermost layer of the eyeball] from its connection at the back of the eye)~     with exposure to oral ciprofloxacin or oral fluoroquinolones.~   "
128807|NCT01881425|"~     Assess the safety and effectiveness of the InnFocus MicroShunt when used to lower intraocular~     pressure (IOP) in subjects with primary open angle glaucoma where the IOP is not controlled~     when using maximum tolerated glaucoma medications.~   "
128808|NCT01881412|"~     Many children have asthma and this causes problems with their health. A lot of children with~     uncontrolled asthma use emergency departments for asthma care, and so this is an ideal place~     for an intervention for these children. One intervention is prescribing inhaled steroids to~     children with uncontrolled asthma, but currently this is rarely done in the emergency~     department. Inhaled steroids have been shown to be good at making children better long-term~     when they have uncontrolled asthma.~      This study identifies children in the emergency department with uncontrolled asthma using a~     tool called the Pediatric Asthma Control and Communication Instrument (PACCI). If children~     meet criteria for uncontrolled asthma they will be randomly assigned to either: 1) routine~     asthma care which includes close follow up with their doctor or 2) prescribing of an inhaled~     corticosteroid from the emergency department. The investigators hypothesize that children who~     are prescribed inhaled steroids for uncontrolled asthma from the emergency department will~     have better 6 month asthma control than children who receive routine asthma care.~   "
128809|NCT01881399|"~     The burden of iatrogenic bile duct injury (BDI), the most feared complication of laparoscopic~     cholecystectomy (LC), is extremely high and the repercussions on the patient's outcomes may~     be severe ranging from intraoperative repair to liver transplant or patient's death.~     Different techniques have been proposed to prevent BDI.~      Our hypothesis is that a fluorescence-based Imaging would allow visualization of the biliary~     tree anatomy as good as with the Intraoperative Cholangiogram with several main advantages:~        1. ease of use~        2. lack of invasiveness~        3. absence of ionizing radiation to the patient and the operating staff~        4. performed prior to any dissection (prior to critical view of safety)~      Capacity of enhanced-reality based on virtual cholangiography (computer treatment of MRI~     images) to guide biliary tree anatomy visualization will be also evaluated in this study.~      The study requires a 2-month patient participation.~   "
128810|NCT01881386|"~     This project is designed to investigate whether measurements of lactate in tumours, made~     using a magnetic resonance technique similar to MRI, is an effective non-invasive method to~     detect whether some new targeted drugs are having their desired effect.~      The study hypothesis is that by using magnetic resonance spectroscopy techniques, we will be~     able to observe changes in tumour lactate levels in vivo, in response to treatment.~   "
128811|NCT01881373|"~     The goal is to build social/cultural, political/economic, and physical/built environments~     that will promote active play and intake of healthy food to prevent young child obesity in~     the Pacific Region. Our methods will support local culture in order to achieve this goal in~     these remote, underserved native populations. CHL will engage the community, and focus on~     capacity building and sustainable environmental change.~      The focus of the CHL community-based program is to promote healthy eating and to increase~     physical activity. In order to demonstrate effectiveness, the investigators will recruit and~     measure children in six communities selected in each of our jurisdictions in the Pacific.~     These represent intervention communities, comparison communities, and temporal communities.~   "
128812|NCT01881360|"~     Fibromyalgia patients frequently suffer from symptoms similar to those of adult celiac~     disease, raising the possibility that some fibromyalgia patients experience oligosymptomatic~     celiac disease or non-celiac gluten intolerance. The objective of this study is to compare~     the effect of a gluten-free diet with a hypocaloric diet in patients with fibromyalgia and~     celiac-type symptoms.~   "
128813|NCT01881347|"~     The present study is designed to test the hypothesis that resveratrol supplementation will~     improve the function of the endothelium in patients with type 2 diabetes mellitus.~      The function of the endothelium will be tested with a non-invasive technique that uses~     ultrasound to measure the amount of dilation that occurs in the brachial artery following~     5-minute cuff occlusion. To help us understand potential mechanisms of benefit, we will also~     collect blood, urine, and cell samples and test the effects of treatment on protein~     expression, nitric oxide production, and function of mitochondria.~   "
128814|NCT01881334|"~     The objective of this study is to make T-cell depleted stem cells from a family member who is~     a half match (haplo-identical) available on an expanded access basis to patients receiving~     one or two unrelated cord blood transplants who are at a higher risk of not engrafting in a~     safe amount of time. The purpose of the related stem cells is the give the bone marrow a~     jump start towards recovery. Ultimately, the cord blood cells will grow and permanently~     rescue the bone marrow.~   "
128848|NCT01880892|"~     In patients with gastroesophageal reflux and/or laryngopharyngeal reflux with cricopharyngeal~     hypertrophy or Zenker's diverticulum, does cricopharyngeal myotomy increase the amount of~     laryngopharyngeal reflux?~   "
128815|NCT01881321|"~     Study design: This is a 2-phase study. During the first phase, the investigators developed a~     contraceptive counseling intervention based on the principles of Motivational Interviewing,~     trained counselors, and conducted a small pilot study to develop skills and refine the~     intervention.~      The second phase is this feasibility randomized controlled trial (RCT) to compare outcomes~     between:~      Group 1 - Women randomized to a 20-40 minute contraceptive counseling session based on the~     principles of motivational interviewing, vs.~      Group 2 - Women receiving usual clinic care.~      Population: Women, aged 15-29 years, presenting to the University of Chicago family planning~     clinic for termination of an unintended pregnancy.~      Hypothesis: A larger proportion of women who are randomized to receive the MI counseling~     intervention will be using very effective contraception 3 months after the intervention.~   "
128816|NCT01881308|"~     The purpose of this study is to assess the effect of disease-modifying anti-rheumatic drugs~     (DMARDs) dose reduction in patients with rheumatoid arthritis (RA).~      Remission is the treatment target in RA, but knowledge about the best way to treat RA~     patients who achieve sustained remission is limited. DMARDs have potential serious adverse~     events, and biologic DMARDs are costly to the society. The objectives for ARCTIC REWIND are~     to assess the effect of tapering and withdrawal of DMARDs on disease activity in RA patients~     in sustained remission, to study predictors for successful tapering and withdrawal of DMARDs~     in this patient group, and to study cost-effectiveness of different treatment options in RA~     remission.~      ARCTIC REWIND is a randomized, open, controlled, parallel-group, multicenter, phase IV,~     non-inferiority strategy study. Patients with less than five years of disease duration and~     stable remission for at least 12 months are randomized to either continued stable treatment~     or tapering and withdrawal of DMARDs, including tumor necrosis factor (TNF) inhibitors and~     synthetic DMARDs. Patients are assessed by clinical examination, patient reported outcome~     measures, ultrasonography, MRI and X-ray, and monitored for adverse events. The primary~     endpoint of the study is the proportion of patients who are non-failures (have not~     experienced a flare) at 12 months. Secondary endpoints include composite disease activity~     scores and remission criteria, joint damage and inflammation assessed by various imaging~     modalities, work participation, health care resource use and health related quality of life.~   "
128817|NCT01881295|"~     This study is designed to compare the effect of sources of potassium on uptake and the effect~     of potassium on blood pressure.~   "
128818|NCT01881282|"~     The purpose of this study is to compare the therapeutic effect and safety of compound~     carraghenates cream with Mayinglong musk hemorrhoid (swollen veins in the lower part of the~     rectum or anus) ointment in the treatment of hemorrhoids, especially regarding the relief of~     pain.~   "
128819|NCT01881269|"~     The purpose of this study is to evaluate the performance of the software that calculates~     respiration rate for the study pulse oximetry monitoring system during transitions of~     ventilation type from spontaneous breathing to controlled ventilation.~   "
128820|NCT01881256|"~     This is a longitudinal, observational study on nutrition, growth and body composition in~     preterm infants. Aims to determine the adequacy of actual nutrient intake during the preterm~     period by investigating associations between macronutrient supply, growth, and body~     composition at 34-weeks gestation, term equivalent and 2-month corrected gestational age.~   "
128821|NCT01881243|"~     The broad objective of this study is to test the association between hyperoxia exposure after~     resuscitation from cardiac arrest and outcome. Our overarching hypothesis is that hyperoxia~     after ROSC is associated with increased oxidative stress and worsened neurological and~     cognitive outcomes.~   "
128822|NCT01881230|"~     The purpose of this study is to compare the safety and efficacy of nab-paclitaxel in~     combination with either gemcitabine or carboplatin to the combination of gemcitabine and~     carboplatin as first line treatment in female subjects with triple negative metastatic breast~     cancer (TNMBC) or metastatic triple negative breast cancer.~   "
128823|NCT01881217|"~     An open-label, non-randomized, Phase I dose-escalation study designed to assess the safety,~     tolerability, pharmacokinetics(PK) /pharmacodynamics( PD) and tumor response profile of~     BAY1179470 in subjects with advanced, refractory solid tumors~   "
128824|NCT01881204|"~     The primary objective of this clinical trial is to test hesperidin with and without~     CALCILOCK® for bone resorption suppressing effect in postmenopausal women. The secondary~     objective is the comparison between 41Ca technology and classical biomarker to evaluate bone~     resorption.~   "
128825|NCT01881191|"~     This study will evaluate the effects of Aubagio on changes in the brain using MRI.~   "
128826|NCT01881178|"~     This study has been developed to investigate the anti-inflammatory effects of a commercial~     product (Nopalea) containing Prickly Pear Cactus Fruit Juice in healthy adults. The research~     method employs a double blind, placebo controlled, and time-series (repeat measures) design~     with high-sensitivity C-Reactive Protein (HS-CRP) serving as a marker for inflammation -~     testing for levels of CRP at time points: baseline (pre-test), 8 weeks (60 days) and 12 weeks~     (90 days). The final time point (i.e., 12 weeks) will serve as the post-test. It is expected~     that baseline CRP levels in healthy participants will decline.~   "
128827|NCT01881165|"~     This study aims to determine whether a cranberry concentrate reduces recurrent urinary tract~     infections (UTIs) in women who consume it. About 150 adult women will participate in this~     study. Subjects will be randomized (like flipping a coin) to take either cranberry capsule or~     a placebo for 12 months. We expect cranberry supplement to have better results than the~     placebo. Subjects will not know which supplement they are taking. The primary outcome is the~     number of UTIs over 12 months.~   "
128828|NCT01881152|"~     The starting hypothesis is that a multilevel educational campaign, specifically developed for~     the local community, can increase public stroke awareness and reduce pre-hospital delay.~      The effectiveness of such intervention will be evaluated according to a cluster randomized,~     stepped wedged design. The clusters are the four communities of the Area Vasta Emilia Nord,~     AVEN (Parma, Piacenza, Modena e Reggio Emilia). As analysis Units, we will consider the~     patients consecutively admitted to the six participating hospitals throughout the study~     period, for suspected stroke or transitory ischemic attack (TIA).~   "
128829|NCT01881139|"~     The purpose of this study is to monitor the impact of exercise training on cardiac functions~     and lipoprotein lipids.~   "
128834|NCT01881074|"~     Diabetes mellitus affects > 171 million people worldwide, with type II diabetes being the~     most prevalent, affecting 85-95% of the diabetic population. Unfortunately, despite~     conventional medical treatment, some diabetic patients do not seem to be able to reach~     desirable metabolic control. This is a double-blinded, randomized study investigating the~     effects of triclosan containing toothpaste (commercial name: Colgate Total) on the response~     to periodontal treatment in type II diabetic patients with periodontal disease. The~     investigators believe that using triclosan containing toothpaste during periodontal treatment~     will decrease the local inflammatory response and that this reduction will improve~     periodontal status and metabolic control.~   "
128835|NCT01881061|"~     The purpose of this study is to evaluate the role of lung sonography during different PEEP~     settings in ICU patients with ARDS.~   "
128836|NCT01881048|"~     The purpose of this study is to evaluate the effect of two anti-inflammatory drugs, fish oil~     capsules and the COX-2 inhibitor celecoxib, on pregnancy associated breast cancer (PABC).~     Short-term intervention with anti-inflammatory medications will demonstrate a reduction in~     the inflammation and immune suppressive phenotype of PABC, and decreased metastatic potential~     in PABC. This unique window in breast cancer management serves as a valuable opportunity to~     obtain preliminary data on biomarkers and the alterations that occur when the system is~     troubled by a drug or other intervention which will be instrumental in designing future~     therapeutic or preventative strategies for larger clinical study.~   "
128837|NCT01881035|"~     The study is designed to investigate the efficacy of renal nerve denervation in treating~     drug-resistant hypertension in patients with end stage renal disease.~   "
128838|NCT01881022|"~     Diagnosis and treatment of breast cancer often leads to lower levels of sexual desire,~     decreased sexual arousal, painful intercourse, and difficulties achieving orgasm, and thus~     adversely impacts sexual functioning and intimacy. Despite the overwhelming evidence that~     many couples experience sexual distress following breast cancer, very few interventions have~     been designed exclusively to address these concerns. The purpose of this study is to develop~     and evaluate an online psychosexual program geared to the unique needs of couples~     experiencing sexual distress after breast cancer. This study will utilize a web-based~     approach, allowing couples to participate in the program from the privacy and comfort of~     their homes, and providing a resource to couples who may not otherwise be able to readily~     access support. Accordingly, this project has the potential for widespread positive impact~     for couples affected by breast cancer.~   "
128839|NCT01881009|"~     To test the function and safety of the Medtronic Overnight Closed Loop (OCL) System in a~     closely monitored 12 hour overnight inpatient study. Once the safety of the device has been~     validated we will move the study to an outpatient diabetes camp setting. The camp setting~     will allow us to obtain pilot efficacy and safety data in a real-life environment.~      We plan to compare the subject control nights to the subject nights on the OCL system to~     assess the percent of sensor glucose readings in the target range of 70-150 mg/dl. Based on~     previous research, we anticipate that the use of the OCL system will contribute to a greater~     percentage of sensor glucose readings in the target range.~   "
128840|NCT01880996|"~     Oncologic patients often report increased fatigue during and after chemotherapy. Evidence~     suggests Tai-chi/Qi-gong may improve quality of life (QOL) in oncologic patients treated with~     chemotherapy. Previous studies, mostly performed in a population of breast cancer patients,~     have demonstrated the benefits of Tai-chi/Qi-gong practice in improving quality of life (1),~     reducing bone resorption (2), preventing the decrease of blood counts (WBC and Hb) (3), and~     reducing inflammation (4).~      The aim of this pilot study is to evaluate the effect of Tai-chi/Qi-gong on QOL, sleep, and~     fatigue in patients with gynecological malignancies, particularly in patients with ovarian~     cancer.~   "
128841|NCT01880983|"~     The purpose of this study is to identify the biochemical/genetic defects in erythropoietic~     protoporphyria (EPP). People with EPP have skin sensitivity to sunlight and occasionally~     develop liver disease. In this study, the investigators hope to learn the nature of the~     biochemical/genetic defects in EPP because this may help explain the severity of these~     clinical features.~   "
128842|NCT01880970|"~     The aim of this trial is to test the efficacy of an infant formula containing synbiotics on~     the prevention of gastro-intestinal infections.~   "
128843|NCT01880957|"~     The primary aims of this study are to:~        1. Quantify serotonin transporter (5-HTT) binding potential (BP) in vivo in bipolar~          disorder patients (BPD) during a major depressive episode (MDE).~        2. Assess the effect of lithium treatment of bipolar disorder on 5-HTT.~        3. Assess the effect of lithium treatment of bipolar disorder on 5-HT1A BP.~        4. Assess the effect of lamotrigine treatment of bipolar disorder on 5-HTT and 5-HT1A BP.~        5. Assess the effect of lithium treatment of unipolar depression on 5-HTT BP.~   "
128844|NCT01880944|"~     Non-contrast MRI with T2 fat suppression has been a useful imaging modality in evaluation~     spinal trauma.~      However, the role of contrast enhancement has not investigated in patients with spinal~     trauma.~      Therefore, this prospective study aims to evaluate the usefulness of contrast enhanced MRI~     for spinal trauma W/U clinically.~      The study hypothesis is that there is no additional gain in addition of contrast enhanced~     study to routine non-contrast MRI.~   "
128845|NCT01880931|"~     To find out the effect site concentration of remifentanil for preventing QTc interval~     prolongation during intubation under propofol-remifentanil anesthesia in normotensive and~     hypertensive patients~   "
128846|NCT01880918|"~     The proposed study is a post marketing, observational, retrospective data collection intended~     to gather and record data on patients treated with the ColonRing device in routine clinical~     practice at 4-6 centers. The data will assist in future evaluating the performance of the~     ColonRing device in regards to the creation of a colorectal anastomosis in Low Anterior~     Resection procedures.~      Hypothesis: The performance of the ColonRing, determined by the rate of complications, will~     be within the acceptable range reported in the literature for alternative treatment~     modalities.~   "
128847|NCT01880905|"~     Ovarian torsion is one of the gynecological emergency. This complication requires high~     clinical suspicion and early detection, to prevent permanent loss of ovarian function. The~     long uterine ovarian ligament could be a risk factor for ovarian torsion. We want to measure~     the uterine ovarian ligament length during routine laparoscopy/laparotomy and to compare the~     length between the torsion group and other non torsion patients~   "
128849|NCT01880879|"~     research topic:helios After registration of clinical research bidders:kinhely bio-tech Co.Ltd~     study design:A prospective single treatment group multicenter clinical study Number of~     patients:Included in the subjects of 800 cases Main research purpose:Evaluation of safety and~     effectiveness Mainly studies the finish:1 year target lesion of the failure~      Inclusion criteria :~      one:Gender not limited at the age of 18 to 80 two:myocardial ischemia or angina symptoms of~     coronary artery disease three:A narrow is less than 50% treated with stents four:Comply with~     the instructions five:Voluntarily signed the informed consent form exclusion criteria:~     one:Pregnant women two:cardiac shock three:Against a suppository medicines or allergies~     four:Participated in other test research in the first 6 months five:Within 6 months after PCI~     plans to accept non cardiac surgery six:Non-compliant patient Follow-up time:A month for 6~     months and 9 months to 1 year to 2 years follow-up progress plan:All center within 6 months~     after start of complete into the group~   "
128850|NCT01880866|"~     Pulmonary arterial hypertension (PAH) is a progressive disease that results in severe~     activity limitation and death. There are few treatments for PAH and the available medications~     are expensive, difficult to administer and have significant toxicities.~      (-)-Epicatechin is a non-toxic compound that naturally occurs in foods such as tea, wine and~     chocolate. Clinical intervention studies using dark chocolate in normal volunteers and~     subjects at risk for or with established cardiovascular disease have demonstrated~     improvements in peripheral and coronary vascular endothelial function, blood pressure,~     lipids, glucose tolerance and inflammatory markers.~      Our study intends to examine the hemodynamics effects of purified (-)-epicatechin in subjects~     with pulmonary arterial hypertension. We hypothesize purified (-)-epicatechin will reduce~     pulmonary vascular resistance in patients with pulmonary arterial hypertension.~   "
128851|NCT01880853|"~     Early detection of breast cancer through screening has been a common practice in the United~     States and several European countries for decades.It is effective in reducing the mortality~     of breast cancer and improving the postoperative quality of life of patients. Mammography has~     been the standard imaging method for the screening, and in recent years, a supplemental~     ultrasound exam is also recommended.A prospective, multi-center, randomized trial is needed~     to define an optimal screening strategy that suits Chinese women and the socioeconomics of~     China.~   "
128852|NCT01880840|"~     The purpose of this study is to compare the safety of 2 different doses of the~     investigational use of an allergy medication (Astepro Nasal Spray) in the treatment of~     allergic rhinitis (AR). This is an open-label study; that is, parent and child will know~     which group each is in.~   "
128853|NCT01880827|"~     Obesity is a worldwide problem and leads to multiple metabolic and endocrinological problems.~      Bariatric surgeries are a growing field as a treatment choice for morbid obesity (BMI > 35~     kg/m2). Clinical and research evidence shows that shortly after RYGB, T2DM resolves with~     improving glucose tolerance. Foregut hypothesis behind bariatric surgeries postulate, that~     bypassed portions of intestine contain a substance, that acts as an anti-incretin, ie. to~     counteract metabolically favourable incretins. In view of the recent studies, it may be that~     GIP is really the anti-incretin behind this hypothesis.~      The current study is conducted to investigate the vasoactive roles of the GIP. The~     investigators aim to show that GIP is the major contributor to the blood flow and tissue~     blood volume observed in postprandial state.~   "
128854|NCT01880814|"~     The purpose of the study is:~        1. To conduct a pilot SMART (Sequential, Multiple Assignment, Randomized) study with the~          long-term goal of developing a personalized treatment for child depression.~        2. To collect pilot data on ways to personalize treatment for child depression using~          cognitive behavioral therapy (CBT), caregiver-child treatment, or both.~   "
128855|NCT01880801|"~     The purpose of this study is to determine whether mothers with Idiopathic thrombocytopenic~     purpura (ITP) has antibodies against platelets in breastfeeding milk aside control group of~     healthy mothers.~      In order to prevent severe thrombocytopenia in infants born to mothers with ITP.~   "
128856|NCT01880788|"~     The study will be designed as a case control evaluation to compare the genetic profiles of~     three groups of patients categorized according to diagnosis.~      Group 1 - CNV secondary to CSC Group 2 - CSC without CNV Group 3 - CNV secondary to advanced~     AMD.~   "
128857|NCT01880775|"~     In this prospective randomized study the investigators aimed to investigate difference of the~     duration of spinal anesthesia, discharge times and efficacy between low dose heavy~     Prilocaine-Fentanyl and heavy Bupivacaine-Fentanyl in outpatient minor anal surgery.~   "
128858|NCT01880762|"~     Developing an MRI protocol at 1.5 T allowing quantification of the hematopoietic, fatty and~     trabecular moieties of marrow. An ideal protocol would differentiate red marrow from~     neoplastic cellular infiltration, and detect loss of trabecular bone. This study assesses the~     feasibility of a multiple gradient echo sequence for differentiation of water and fat~     constituents of marrow, combined with T2* mapping to interrogate the trabecular component The~     investigators hypothesize that these techniques will allow better identification of lesion~     type than routine MR sequences, and can be used to quantitatively characterize myelomatous~     marrow replacement, with iliac crest biopsy (which is routinely performed in the diagnosis of~     myeloma) as gold standard.~      Fluoro-deoxyglucose (FDG)/PET CT imaging can detect FDG uptake in active myeloma and is~     obtained routinely for certain cohorts of patients with myeloma. PET/CT is commonly used in~     both initial whole body assessment and in monitoring remission. PET has been found to be~     about 59% sensitive and 75% specific for detection of myeloma .~      Myelomatous lesions are detected on MRI by the replacement of marrow fat. Routine MRI however~     is limited by scope/field of view, usually evaluating marrow in a single anatomic region~     (such as an extremity, the pelvis or spine). To assess the diffuse marrow involvement in MM,~     whole body MRI imaging potentiates near global assessment of the marrow, which aids in~     evaluating tumor burden, and may be useful in staging.~   "
128859|NCT01880749|"~     The primary objective is to estimate the proportions of vestibular schwannomas (VS) and~     meningiomas after 10 days of exposure to the study drug RAD001 at a dose of 10 mg daily, as~     determined by immunohistochemistry. This is a phase 0 PK (pharmacokinetic) and PD~     (pharmacodynamic) study of RAD001 in patients with Neurofibromatosis Type 2-related and~     sporadic VS and meningiomas. Enrolled patients will take RAD001 prior to a scheduled VS or~     meningioma surgery, and blood and tissue samples will be obtained for further analysis.~   "
128861|NCT01880723|"~     Our aims were to determine if exhaled breath condensate (EBC) could detect differences in ion~     regulation between cystic fibrosis (CF) and healthy and measure the effect of the albuterol~     on EBC ions in these populations. We hypothesized EBC chloride and sodium would be lower in~     CF patients at baseline and that albuterol would decrease EBC sodium and increase EBC~     chloride.~   "
128862|NCT01880710|"~     319 Women undergoing hysterectomy for benign (not cancer) indications were randomly allocated~     to 2 types of surgery (Total (TAH) and Subtotal (SAH)) abdominal hysterectomy 15 years ago.~     They were followed by questionnaire at time of surgery and up to 5 years (not yet published)~     after the surgery and evaluated regarding following outcomes: Urinary incontinence, pain,~     bowel problems, per and postoperative complications, sexuality, quality of life, pelvic organ~     prolapse and vaginal bleeding. Now the investigators are conducting a 15 year follow up with~     the same out-come measures but also including physical examinations regarding Urinary~     incontinence, voiding difficulties, pelvic organ prolapse and problems with the cervix. The~     investigators' hypothesis is that several of the out-come measures will be present in more~     cases than earlier due to age and menopausal changes. The investigators expect more urinary~     incontinence in the subtotal group as this was seen at earlier follow ups. The investigators~     expect to find more women with pelvic organ prolapse with the physical examination than by~     questionnaire alone, possibly with a higher incidence in the subtotal group.~   "
128863|NCT01880697|"~     The present study is designed to confirm the safety and immunogenicity of cell-derived,~     trivalent, surface antigen, inactivated influenza vaccine in 2 age cohorts: 18 to ≤60 years~     and ≥61 years and the antibody response to each influenza vaccine antigen, as measured by~     Single Radial Hemolysis (SRH) or Hemagglutination Inhibition (HI) at approximately 21 days~     post immunization. The vaccine composition will be based on the WHO-recommended influenza~     strains for the 2013/2014 Northern Hemisphere vaccine. The results of this study are intended~     to support the use of this vaccine in future influenza seasons if the recommended vaccine~     composition remains the same, in compliance with the requirements of the current EU~     recommendations for clinical trials related to yearly licensing of influenza vaccines.~   "
128864|NCT01880684|"~     The aim of this study is to evaluate the correlation of capnography with non-invasive~     measurement of cardiac output with the FloTrac/EV1000 following a reversible fluid challenge,~     a passive leg raising maneuver, using thermodilution as the gold standard.~      The main hypothesis is a correlation of 0.8 between the increasing of ETCO2 and the~     increasing of ejection volume measured by FloTrac/EV1000 following a passive leg raising~     maneuver.~   "
128865|NCT01880671|"~     The purpose of this study is to evaluate the efficacy of a novel therapy for treatment of~     migraine, pain reduction and relief of associated symptoms during ongoing migraine attacks,~     and presence of a preventive effect post treatment.~   "
128866|NCT01880658|"~     RATIONALE: Surgical resection and adjuvant therapy has become the main treatment for~     resectable colorectal cancer. Treatment with current strategies, however,recurrent rate is~     high for stage IIIC or R0 resected stage IV. The efficacy and safety of maintenance therapy~     with capecitabine is still unknown.~      PURPOSE: This single arm study is exploring surgical resection and adjuvant chemotherapy~     followed by maintenance therapy with capecitabine to see the efficacy and safety, then to~     investigate the effect of maintenance therapy for stage IIIC or R0 resected stage IV~     colorectal cancer.~   "
128867|NCT01880645|"~     The goal of this clinical research study is to learn if it is feasible to use find (using~     ultrasound) and surgically remove cancer that has spread to the lymph nodes, during routine~     lymph node surgery.~      In standard care, all affected lymph nodes are removed. In this study, however, the cancerous~     lymph nodes will be removed separately and then the rest of the lymph nodes under the arm~     will be removed after that.~   "
128868|NCT01880632|"~     1. Target population:locally advanced gastric adenocarcinoma (LAGC, cT2~3/N+M0,or~          cT4aN+M0);no previous chemo or radio therapy.~        2. Primary objective:Response rate of XELOX in the neoadjuvant setting of LAGC.~           Secondary objectives:~             -  The progression free survival (PFS) in the perioperative treatment of locally~               advanced gastric adenocarcinoma (cT3/N+M0,or cT4aN+M0);~             -  percentage of pathological response ; percentage of grade 3 or 4 adverse events as~               safety profile of perioperative treatments;~             -  D2 resection -rate after neoadjuvant chemotherapy of XELOX;~             -  Overall survival;~             -  QOL during the whole period of treatment.~        3. Trial design:This is a multicenter, single arm, open-label, phase II study to evaluate~          the efficacy and safety of Oxaliplatin plus capecitabine(XELOX) in the perioperative~          treatment of locally advanced gastric adenocarcinoma in combination with D2 resection.~        4. Treatment plan:Patients will be given the perioperative chemotherapy as below once~          recruited:Schedule of Oxaliplatin plus capecitabine (XELOX) will be as follow:~          Capecitabine 1000 mg/m2 ，bid,d 1~14 every 3 weeks(treatment for 2 weeks and rest 1~          week)Oxaliplatin：130mg/m2， iv infusion over 2h，d1,every 3 weeks.~        5. Number of subjects:50 patients.Number of centers 5 sites, which have the high volume of~          gastric operations in China, more than 500 per year.~   "
128869|NCT01880619|"~     This study will be conducted to compare the effectiveness of alpha blocker (Tamsulosin) and~     Anticholinergic (Solifenacin) in relieving lower urinary tract symptoms caused DJ ureteral~     stents.~   "
128870|NCT01880606|"~     Evaluation of the efficacy of laser-based endomicroscopy as a complement to white-light~     colonoscopy and chromoendoscopy for early detection of colon dysplasia in patients with~     PSC-IBD. White-light colonoscopy is a routinely used procedure in colorectal cancer~     surveillance programs. However, it does not permit detection of early dysplastic lesions.~     Chromoendoscopy by applying a dye (indigo-carmine) through the colonoscope helps to identify~     flat lesions but is not suitable for accurate endoscopic diagnosis of dysplasia and~     intraepithelial neoplasia Under this aim we will perform a clinical study evaluating a newly~     developed technique allowing for in vivo confocal microscopy assessment of the colon mucosa~     using laser-based endomicroscopy together with intravenous administration of fluorescein~     (FITC).~   "
128894|NCT01880294|"~     The purpose of the study is to evaluate the differences or similarities in the results~     obtained with two different scoring systems for chronic constipation in Asian participants~     consulting in gastroenterology clinics (the Asian Neurogastro-enterology and Motility~     Association (ANMA) chronic constipation (CC) diagnostic tool (diagnosis questionnaire) and~     the ROME III diagnosis criteria (western gold standard).~   "
128871|NCT01880593|"~     The purpose of this study is to test the antidepressant effect of ketamine when given~     repeatedly over a period of 1 week, as well as the use of Lithium as a relapse-prevention~     strategy for patients with treatment-resistant depression (TRD) who respond to an initial~     series of ketamine infusions. Ketamine is a Food and Drug Administration approved anesthetic~     (a drug used to produce loss of consciousness before and during surgery). Ketamine is not~     approved for the treatment of major depressive disorder and is considered experimental in~     this study. An additional purpose of this study is to research the effects of ketamine on~     brain function.~      You may qualify to take part in this research study because you have been diagnosed with~     major depressive disorder (MDD) and have not responded to past treatments.~   "
128872|NCT01880580|"~     The objective of this pilot study is to investigate Cone Beam Computed Tomography Imaging~     (CBCT), with the primary goal, the accumulation of a body of evidence to provide preliminary~     data for a future extensive clinical trials.~   "
128873|NCT01880567|"~     Objectives:~      Primary Objective~        -  To evaluate the response rate of Ibrutinib plus rituximab in patients with relapsed~          and/or refractory mantle cell lymphoma (MCL).~        -  To evaluate the safety and response rate of Ibrutinib plus rituximab in elderly patients~          (> 65) with newly-diagnosed, untreated MCL.~   "
128874|NCT01880554|"~     Hypothesis: Use of contrast ultrasound showed interesting results, which can increase~     ultrasonography sensitivity performed during surgery in the evaluation of operable liver~     metastases.~      This study is a two-stage phase II multicenter study (Simon's two-stage).~   "
128875|NCT01880541|"~     The emergence of cognitive disorders after surgery under general anesthesia (GA) is the~     second leading cause of patient complaints (after dental debris caused by intubation~     techniques). These cognitive disorders can range from simple reversible confusion (26%) with~     postoperative cognitive dysfunction without actual recovery (10%).~      The hypnosedation is an ancient technique of anesthesia expanding its effects on cognitive~     function remain to this day unknown, but appear promising.~   "
128876|NCT01880528|"~     This pilot clinical trial studies lisinopril in reducing shortness of breath caused by~     radiation therapy in patients with lung cancer. Lisinopril may decrease the side effects~     caused by radiation therapy in patients with lung cancer.~   "
128877|NCT01880515|"~     1. Advanced NSCLC has a poor prognosis and the positive impact of chemotherapy is limited~          by the development of intrinsic and acquired resistance.~        2. Over the past decade, less toxic agents such as the innovative targeted therapies, i.e.~          erlotinib or gefitinib, have the potential to improve the effectiveness and keep a good~          quality of life with a low toxicity~        3. BIBW2992 (afatinib), an aniline-quinazoline, is an epidermal growth factor receptor~          (EGFR) and human epidermal growth factor receptor 2 (HER-2) irreversible inhibitor, and~          it has activity against erlotinib-resistant isoforms having mutations in EGFR and HER-2.~        4. This molecule has shown benefits as a single agent in pre-treated patients who have~          progressed despite platinum-based chemotherapy, with a minimal toxicity compared to~          chemotherapy.~        5. BIBW2992 is associated with adverse effects similar to those for erlotinib and~          gefitinib, such as rash and diarrhea. These symptoms can reduce the quality of life (QL)~          in patients and lead to inconsistent EGFR inhibitor dose administration~        6. There is not a standard treatment for rash. However, case reports have tried to~          demonstrate the benefit in the treatment of these cutaneous injuries obtained with~          alcohol-free emollients, sunscreen with titanium dioxide or antibiotic (topic or oral)~          treatment regimens that include clindamycin or doxycycline, as well as anti-inflammatory~          drugs such as steroids and isotretinoin.~        7. In order to reduce the incidence and severity of cutaneous toxicities, we will compare~          the prophylactic antibiotic treatment using tetracycline and general dermatological~          recommendations versus using only dermatological recommendations, in patients initiating~          the treatment with BIBW2992.~   "
128878|NCT01880502|"~     A randomized, double-blind, placebo-controlled, single-dose, dose escalation study (Phase I)~     to evaluate the tolerability and pharmacokinetics of Belviq in adult Korean volunteers.~   "
128879|NCT01880489|"~     The objective is to expand and refine an intervention for transgender women (TW) into a~     7-session individual- and group-based intervention that is scalable for community settings to~     reduce sexual risk and substance use and to increase stigma-coping and risk-buffering~     behaviors among TW in NYC. The investigators will pilot test the intervention with 20 TW and~     subsequently, conduct a randomized controlled trial with 240 TW to compare the intervention~     to a wait list control condition.~   "
128880|NCT01880476|"~     This study will examine the feasibility and acceptability of a 6-month interprofessional~     community-based health promotion program, and explore its effects on older adults'~     self-management of Type 2 Diabetes (T2DM). Recently enrolled clients of Diabetes Care Guelph~     (DCG), who are age 65+ and have at least two other chronic conditions, will be eligible to~     participate. Participants must be English speaking, community-dwelling, independent in~     activities of daily living, and mentally competent to give informed consent. The 6-month~     intervention will consist of: in-home visits by a Registered Nurse and Registered Dietitian~     from DCG; participation in a monthly Diabetes Wellness Day group program offered through the~     Guelph Wellington Seniors Association (GWSA) together with DCG; peer support from trained~     volunteers at the Diabetes Wellness Day group program; care coordination by the DCG~     Registered Nurse to help participants access necessary supports and services; and monthly~     team conferences between care providers at DCG and the GWSA to develop a client-centred plan~     of care. To evaluate the program, participants will complete interviewer-administered~     questionnaires before and after the intervention, and care providers and peer volunteers will~     take part in group interviews.~   "
128881|NCT01880463|"~     The VITamin D and OmegA-3 Trial (VITAL; NCT 01169259) is a randomized clinical trial in~     25,875 U.S. men and women investigating whether taking daily dietary supplements of vitamin~     D3 (2000 IU) or omega-3 fatty acids (Omacor fish oil, 1 gram) reduces the risk of developing~     cancer, heart disease, and stroke in people who do not have a prior history of these~     illnesses. This ancillary study is being conducted among participants in VITAL and will~     examine whether omega-3 fatty acids or vitamin D3, compared to placebo, reduce the incidence~     and/or progression of dry eye disease.~   "
139710|NCT01738659|"~     The aim of the study was to verify the effects of moderate versus low sodium intake on~     pulmonary capillary wedge pressure (PCWP), determined by Doppler echocardiography and tissue~     Doppler imaging in patients suffering from compensated heart failure.~   "
128882|NCT01880450|"~     Project Prepared is a theoretically based, comprehensive, intensive group intervention that~     is designed to prepare early adolescents for middle adolescence and its challenges. It~     emphasizes skills in avoiding risky sexual situations, and provides medically accurate~     information about sexual development, sexually transmitted infections and pregnancy.~     Effectiveness is measured by using a randomized control trial design and tracking differences~     in cognitive factors (HIV/STI (Sexually Transmitted Infections) knowledge, sexual~     self-efficacy; intention to use a condom); relationship factors (immature romantic beliefs,~     relationship self-efficacy), gender norms (macho man, powerless female), and resilience.~   "
128883|NCT01880437|"~     This study will assess the safety and efficacy of vismodegib in patients with~     relapsed/refractory acute myelogenous leukemia (AML) and relapsed/refractory high-risk~     myelodysplastic syndrome (MDS). Patients in Cohort 1 will receive single-agent vismodegib 150~     mg orally daily. In Cohort 2, patients will receive vismodegib 150 mg orally daily in~     combination with cytarabine 20 mg subcutaneously for 10 days.~      Anticipated time on study treatment is until disease progression, intolerable toxicity, or~     patient withdrawal of consent.~   "
128884|NCT01880424|"~     This clinical trial is an international, multicenter, randomized, double-blind,~     placebo-controlled, parallel-group trial comparing one dose of linaclotide to placebo.~     Approximately 800 patients with a diagnosis of IBS-C (modified Rome III criteria) will be~     randomized at up to 60 trial centers in China, Australia, and New Zealand.~      The trial will consist of up to 21 days of screening, 14 to 21 days of pre-treatment, 12~     weeks of double-blind treatment, and 2 weeks of follow-up. At the end of the Pre-treatment~     Period, patients meeting the entry criteria for this trial will be randomized to one of two~     double-blind treatment groups: 290 ug linaclotide, or placebo (1:1).~   "
128885|NCT01880411|"~     Phase I, Open-Label Study of the Safety, Tolerability, and Immunogenicity of a Three Dose~     Regimen of Escalating Doses of PEK Fusion Protein Vaccine in Women with LSIL or HSIL.~      PEK fusion protein vaccine (PEK + GPI-0100) is safe and well tolerated in patients with~     low-grade squamous intraepithelial lesions (LSIL) or high grade squamous intraepithelial~     lesions (HSIL) of the cervix and induces a measurable immune response.~   "
128886|NCT01880398|"~     Background: Fistula in ano is one of the most common diseases of the ano rectal region.~     Treatment of Fistula in ano has puzzled the medical fraternity due to its complex nature.~     Commonly prevalent surgical treatment for anal Fistula, that is Fistulectomy does not~     provide successful cure for the disease, post operative complications and recurrences being~     common. Acharya Sushruta an ancient Indian Surgeon has described in his text ' Sushruta~     Samhita' about an ancient Ayurvedic technique of medicated thread called Ksharsutra treatment~     for Bhagandara ( Fistula in ano). Treatment of anal Fistula (Bhagandara)and Nadi-Vrana(Sinus)~     with Ksharsutra was practiced by Sushruta (1000-600B.C.) .~      Hypothesis: Aycharya Sushruta advocated Kshar Sutra therapy in Fistula in ano and in various~     types of Fistula.~   "
128887|NCT01880385|"~     Multi-center, non randomised, open label, non controlled pilot study. Evaluating the~     treatment of bevacizumab in association with pre-operative chemotherapy, followed by surgery,~     adjuvant chemotherapy and radiotherapy in Patients with inflammatory breast cancer.~   "
128888|NCT01880372|"~     The purpose of this study is to evaluate the role of alpha lipoic acid in patients who have~     moderate non-proliferative diabetic retinopathy.~      The primary aim of this study is to test the hypothesis that the addition of alpha lipoic~     acid in a diabetic patient's therapeutic regimen can decrease the progression of diabetic~     retinopathy and preserve visual acuity.~   "
128889|NCT01880359|"~     The drug nimorazole belongs to a class of chemicals known as 5-nitroimidazoles. Drugs from~     this class are used against infection. In addition, nimorazole makes tumor cells more~     sensitive to radiotherapy.~      Therefore, the investigators want to find out whether the addition of nimorazole to the~     standard treatment with radiotherapy in combination with chemotherapy with cisplatin shows~     activity against your type of head and neck cancer and is safe.~      Furthermore the investigators will investigate if a specific examination done with your tumor~     tissue will help to predict whether the treatment will work or not.~      To find out if the activity observed with this treatment is not caused by chance alone, the~     investigators need to obtain data from patients who receive this treatment and from patients~     who receive other treatments.~      The data from these two groups of patients will be compared to see which treatment is better.~      Participants will be split into 2 groups. Each group will receive different treatments. The~     treatment each group receives is determined by chance using a computer program. This works~     like flipping a coin and is called randomization. This helps to make sure that groups of~     patients are similar when the study starts. Neither you, your study doctor, nor the study~     staff can influence in which group you will be placed or which treatment you will receive.~      If allocated to group 1, Patient will receive radiotherapy in combination with chemotherapy~     with cisplatin and nimorazole as a pill. This is considered the 'experimental' treatment.~      If allocated to group 2, patient will receive radiotherapy in combination with chemotherapy~     with cisplatin and a so called 'placebo' as a pill. The placebo is a dummy treatment. It~     looks like the real one, but it is not. It contains no active ingredient/medicine.~   "
128890|NCT01880346|"~     The investigators predict that a powder pill form of vitamin D will be more effectively~     absorbed than an oil form of vitamin D in people diagnosed with Cystic Fibrosis.~   "
128891|NCT01880333|"~     The modified Atkins diet is a non-pharmacologic therapy for intractable childhood epilepsy~     that was designed to be a less restrictive alternative to the traditional ketogenic diet.~     This diet is started on an outpatient basis without a fast, allows unlimited protein and fat,~     and does not restrict calories or fluids. Modified Atkins diet is of special importance in~     resource constraint settings with paucity of trained dieticians. However, there is paucity~     published data on the use of the modified Atkins diet in refractory epilepsy in young~     children. This study aims to evaluate the efficacy and tolerability of the modified Atkins~     diet in refractory epilepsy in young children.~   "
128892|NCT01880320|"~     The study hypothesis are based on the assumption that :~        -  CD0271 0.3%/CD1579 2.5% Gel provides superior clinical efficacy compared with Topical~          Gel Vehicle in the overall population and in the subgroup of severe Subjects~        -  CD0271 0.3%/CD1579 2.5% Gel applied once daily for up to 12 weeks has an acceptable~          safety and tolerability profile~   "
128895|NCT01880281|"~     -  The G coupled-protein receptors 99 (GPR99) was discovered in 2002 by Wittenberg et al.~          and is involved as a metabolic receptor. It has been shown that the natural ligand of~          GPR99 is an intermediate in the Krebs cycle, alpha-ketoglutarate (aKG). Studies done on~          rats have shown that aKG is measurable in the blood, freely filtered by the glomerulus~          and highly reabsorbed in the proximal tubule in metabolic acidosis, while it is not~          reabsorbed in metabolic alkalosis. No absorption or secretion of aKG intervene between~          the end of the proximal tubule and the final urine. Thus, having a receptor aKG in the~          distal tubule creates a paracrine communication with the proximal tubule, informing~          about the acid-base status of the body and allows adjustment of the urinary excretion of~          acid or base.~        -  The hypothesis is that GPR99 is aKG sensor in the distal tubules and allow to report the~          acid-base status (determined by the metabolic activity of the proximal tubule) of the~          body to the distal tubule. This can then adapt the urinary excretion of acid or base in~          the final urine. Acidifying the body by a high meat consumption associated with a test~          of acidification, the kidney should reduce its aKG excretion and the concentration of~          this metabolite should be even lower in the urine. And vice versa in the case of~          alkalizing the body through a vegetarian diet associated with an alkalizing test.~        -  Twelve healthy omnivorous volunteers will be selected. First inclusion visit includes~          verification of inclusion/exclusion criteria and signed informed consent. Urine and~          plasma baseline measurements will be performed and volunteers will meet a dietician.~          This person will tell them concerning meat and vegetarian diet as well as how to have a~          diet with 6g of salt per day.Volunteers are then randomized in order to determine which~          diet they will start first.The first phase will last during 4 days. The diet is followed~          during 3 days, and a 24-hour urine collection will begin on the third day at 7: 00 am.~          The fourth day, volunteers will have an investigational's day at the investigation's~          center after completing their urine collection at home (7:00 am). During the day of~          investigation, volunteers will give their urine (8: 00 am, corresponding to the baseline~          urine), and then the meat arm will receive a tablet of 50meq of NH4Cl and the~          vegetarian arm will receive a tablet of 1g of NaHC03. Volunteers will stay in the~          investigation center for 6h. Each hour since 8:00am, a urine sample will be taken, and~          at 3 hours and 6 hours post-tablet, a blood sample will also be made.This~          investigational's day will be followed by one to two weeks of treatment washing out.~          After that, the second phase will begin and will as the first phase excepted that the~          diet will be inversed.~           5 other healthy vegetarian or vegan volunteers are recruited. Inclusion visit is the~          same as omnivorous volunteers. Only investigational's day at the investigation's center~          will be performed (no diet, no urine collection).~   "
128896|NCT01880268|"~     This study integrates the wireless EEG system with an ordinary rehabilitation device (an~     upper limb ergometer, arm bike) used in the Department of Physical Medicine and~     Rehabilitation at our hospital for a brain-computer-interface (BCI)-controlled~     neurorehabilitation device, and aims to test the effectiveness of this device. We hypothesize~     that, the coupling of electroencephalographic signals related with initiation of limb~     movements with a mechanical device which assists the intended movement is effective to~     facilitate motor recovery in patients with brain lesion. We propose to enroll 20 patients~     with cerebrovascular accident (CVA) (4-24 months after the onset of CVA) and the patients~     will be randomly assigned to experimental (using BCI controlled device and undergoing~     standard rehabilitation) and control groups (undergoing standard rehabilitation alone). To~     compare the rehabilitation results among these groups, we propose to use various assessment~     tools including clinical evaluation (Fugl-Meyer assessment, Modified Ashworth scale, Motor~     Activity Log, Functional Independence Measure) as well as functional Magnetic Resonance~     Imaging (fMRI) and Diffusion Tensor Imaging (DTI) before, immediate and 2 months after~     completion of the training protocol.~   "
128897|NCT01880255|"~     In this study, the investigators will be examining the effects of repetitive transcranial~     magnetic stimulation (rTMS) on memory deficits in individuals with schizophrenia and~     schizoaffective disorder. Half of the study participants will be chosen by chance to receive~     active rTMS stimulation while half will be chosen by chance to receive sham rTMS. Sham rTMS~     will feel the same as active rTMS only there will be no direct brain stimulation. This is~     necessary to ensure that active rTMS is efficacious in the enhancement of memory in~     individuals with schizophrenia. Based on results from a recently published pilot study, the~     investigators propose that active rTMS treatment will result in a significant improvement in~     working memory performance compared to sham rTMS treatment.~   "
128898|NCT01880242|"~     For the majority of Coronary Artery Disease (CAD), treatment with Percutaneous Transluminal~     Coronary Angioplasty (PTCA) provides high initial procedural success. However, the medium to~     long-term complications range from rather immediate elastic recoil or vessel contraction to~     longer processes like smooth muscle cell proliferation and excessive production of extra~     cellular matrix, thrombus formation and atherosclerotic changes like restenosis or~     angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from~     30%-50%. Such rates of recurrence have serious economic consequences. Bare Metal Stents~     (BMS), designed to address the limitations of PTCA, reduced the angiographic and clinical~     restenosis rates in de novo lesions compared to PTCA alone and decreased the need for CABG.~     BMS substantially reduced the incidence of abrupt artery closure, but restenosis still~     occurred in about 20%-40% of cases, necessitating repeat procedures. The invention of Drug~     Eluting Stents (DES) significantly improved on the principle of BMS by adding an~     antiproliferative drug (directly immobilized on the stent surface or released from a polymer~     matrix), which inhibits neointimal hyperplasia. The introduction of DES greatly reduced the~     incidence of restenosis and resulted in a better safety profile as compared to BMS with~     systemic drug administration. These advantages and a lower cost compared to surgical~     interventions has made DES an attractive option to treat coronary artery disease. This~     observational registry is designed to investigate and collect clinical evidence for the~     clinical performance and safety of the Orsiro Drug Eluting Stent System in an all-comers~     patient population in daily clinical practice.~   "
128899|NCT01880229|"~     BioSensics has developed a Physical Activity Monitoring System (PAMSys) that consists of a~     single wearable motion sensor that is worn on the torso. The objectives of this observational~     study are the following: 1) to test the efficacy of PAMSys for objectively assessing a~     persons risk of falling based on activity data measured during activities of daily living and~     2) to test the efficacy of PAMSys for identifying precise early physical activity or~     functioning indicators of frailty in those who are pre-frail or frail as compared to~     non-frail controls.~   "
128900|NCT01880216|"~     Deep-vein thrombosis (DVT) is a common but under-diagnosed medical condition that occurs when~     a thrombus forms in one of the large veins, usually in the lower limbs, leading to either~     partial or complete blocked circulation. The condition may progress to severe health~     complications, such as pulmonary embolism (PE), if not diagnosed and treated in a timely and~     effective manner.~      The goal of the therapy for lower-extremity DVT is to prevent the extension of thrombus and~     pulmonary embolism in the short term and to prevent recurrent events in the long-term.~     Although anticoagulant therapy decreases the risk of recurrent thrombosis, the treatment also~     increases the risk for major hemorrhage.~      This trial aims to optimize the current medical knowledge on the effectiveness and safety of~     two low molecular weight heparins, bemiparin and enoxaparin in the treatment of deep vein~     thrombosis.~   "
128901|NCT01880203|"~     The purpose of the study is to investigate the contribution of molecular cytological analysis~     (CMA) and shear wave elastography ShearWave (SWE) in the diagnosis of nodules with~     indeterminate cytology (IC)~   "
128902|NCT01880190|"~     Various stimuli such as trauma, infection and major surgery may alter the physiologic immune~     balance and initiate systemic inflammatory processes. This pathophysiological event is~     characterized by the release of potent inflammatory mediators into the circulation.~      Among these, pro- and anti-inflammatory cytokines such as interleukin-6 (IL-6), IL-8 or~     IL-10, ICAM-1 play a dominant role as local or systemic regulators in the acute inflammatory~     response. Recent studies have also investigated the role of matrix metalloproteinases (MMPs)~     in the inflammatory response. The MMPs constitute a family of enzymes that are structurally~     related neutral proteinases. MMPs can degrade essentially all extracellular matrix (ECM)~     components and play an important role in wound healing and remodeling of the ECM. The~     Tissutal Inhibitor MetalloProteine (TIMPs) are important regulator of MMPs activity.~      The inflammatory response coming of surgery mainly affects surgical patients' outcome. Many~     factors may attributed to this response, such as the kind of operation, the extent of~     surgical trauma, the patient's medical history and therapy, as well as the type of anesthesia~     used. Apart from that, the kind of fluids administered for volume replacement was revealed to~     alter the inflammatory processes. Several studies have addressed on this issue mainly~     involved abdominal surgery and provided compelling evidence that perioperative fluid~     optimization produces benefits for the patient, with regard to inflammatory biomarkers such~     as cytokines, matrix metalloproteinases, intercellular adhesion molecule-1(ICAM-1). They~     support that the different volume replacement strategies, using only crystalloids or~     combination of crystalloids with colloids (HES 130/0,4), may have important impact on immune~     response. However, the relevant studies investigated different inflammatory biomarkers, and~     usually involved either metalloproteinases, and their inhibitors (TIMPs) or cytokines.~      In our study we investigated the hypothesis that intra- and postoperative volume replacement~     with HES attenuates inflammatory response to elective abdominal surgery compared to RL fluid~     therapy. For this purpose both metalloproteinases, MMP-9, MMP-13, their inhibitor, TIMP-1,~     cytokines, IL-6, IL-8 and the intercellular adhesion molecule-1, ICAM-1 were investigated~     postoperatively. Their changes during the first 24 postoperative hours consisted our primary~     outcomes.~   "
128903|NCT01880177|"~     The purpose of this qualitative work is to inform the content and structure of a new~     screening measure for identifying undiagnosed at-risk COPD cases in primary care and support~     content validity of the measure. This work will build on the results of a comprehensive~     literature review and data mining analyses by identifying the symptomatic and health event~     experiences of at-risk and newly diagnosed patients, as described by the patients themselves.~     Specific objectives are as follows:~      Objective 1: To elicit concepts and symptom descriptions of COPD from patients with a recent~     diagnosis of COPD and those without a diagnosis but with risk factors for the disease. The~     qualitative information obtained in these focus groups will be used to develop a new~     questionnaire for identifying undiagnosed at-risk COPD cases in various clinic settings.~      Objective 2: To review the new questionnaire with a new set of participants with a recent~     COPD diagnosis or those at risk for COPD to ensure that: (a) the instructions are clear, (b)~     the content of each question is appropriate and understandable to participants, (c) the~     intended connotation of each questions is consistent with participants' interpretation or~     assigned meaning, and (d) to assure that content is not seen as redundant across items. This~     will be done through one-on-one cognitive interviews.~      Objective 3: To gather data on the ease/difficulty of peak flow meter use by people without~     or with a new diagnosis of COPD and the consistency of readings between electronic and~     mechanical readings in these patients. This information will be used to inform the~     development of peak-flow meter instructions for use as part of the screening methodology.~   "
128904|NCT01880164|"~     Quantify the efficacy and cost of nonoperative treatment modalities used for adult spinal~     deformity.~   "
128905|NCT01880151|"~     Recent diagnostic criteria for Alzheimer's disease (AD) recognize an extended spectrum of AD~     stages as part of the disease, including a preclinical stage. This underscores the importance~     of early prognosis of AD when it is still possible to influence the course of the disorder.~     The investigators propose a comprehensive project which will target the data-driven modeling~     of the disease development. This goal will be achieved by creating and validating a battery~     of new sensitive biomarkers for clinical evaluation and prediction of AD in individuals. The~     AD-related brain changes will be assessed by noninvasive functional EEG measured during an~     episodic memory task in subjects at different stages of AD, as well as in healthy controls.~     The novel functional biomarkers will be extracted using a rigorous multistage selection~     procedure involving advanced methods for feature extraction, as well as statistics and~     classification for optimal selection. The ESTIMATE project will serve as a first step in an~     extensive array of research procedures which will enable the early clinical identification of~     Alzheimer's disease in elderly individuals who could then take advantage of preventive~     pharmaceutical therapies.~   "
128906|NCT01880138|"~     Emergence agitation (EA) in children early after sevoflurane anaesthesia is a common~     postoperative problem, with incidence ranging up to 80%. Younger patients, particularly in~     the age range from 1.5 to 5 yr of age, are at increased risk of EA. Preoperative anxiety, as~     measured by the modified Yale Preoperative Anxiety Scale, has been shown to increase the risk~     of EA for each increment of 10 points in the child's state anxiety score. So, Alleviates~     preoperative anxiety in Children maybe decrease the incidence and severity of EA. Preschool~     children enjoy watching animated cartoons, and they can be immersed to animated cartoon so~     they become oblivious of their surroundings. Therefore, viewing an animated cartoon maybe~     reduce preoperative anxiety in children. This study was performed to determine effect of~     animated cartoon for prevention of emergence agitation in children aged 1.5 - 5 yr after~     general anesthesia~   "
128907|NCT01880125|"~     1. Objective: To evaluate the pharmacokinetic profiles of an SR 75 mg tramadol/650 mg~          acetaminophen formulation compared with an immediate release (IR) 37.5 mg tramadol/325~          mg acetaminophen formulation after a single dose and at steady state~        2. Subjects: Healthy subject~        3. Methods: A phase I study to evaluate the pharmacokinetic sustained release and immediate~          release treatment profiles at steady state.~   "
128908|NCT01880112|"~     Patients undergoing Cesarean delivery (C-Section) with a body mass index of 30 or less will~     be given either 2 grams or 4 grams of an antibiotic before surgery. The antibiotic is~     intended to prevent infection from the surgery. It is unknown what the best dose for the~     usual medicine used for this purpose (an antibiotic medicine called cefazolin). Samples of~     the tissue just under the skin will be biopsied at the time the incision is made and at the~     time the cut is stitched or stapled closed. A sample of the muscle of the womb will be taken~     as the womb is stitched closed after the delivery. Blood tests will be done at the start and~     end of surgery to test the antibiotic level. A blood sample will be taken from the umbilical~     cord after the baby has been delivered and the umbilical cord has been cut. The umbilical~     cord blood sample will be tested for the antibiotic level. These tests will be used to find~     out if the usual dose of medicine is enough or if more medicine is needed to prevent~     infection in normal weight women undergoing c-sections.~   "
134861|NCT01802099|"~     The purpose of this study is to assess the hypothesis that, as compared to early intravenous~     feeding, early nutrition via the enteral route is associated with reduced Day 28-mortality in~     critically ill patients treated with mechanical ventilation and vasoactive drug.~   "
128909|NCT01880099|"~     You are invited to participate in a research study at the VA Connecticut Healthcare System~     (West Haven campus) that examines whether a medication called galantamine can improve your~     learning and memory, and also help you to quit smoking. You have been invited to participate~     because you currently smoke cigarettes, and want to quit smoking. If you are eligible and~     agree to be in the study, your participation will last for approximately 8 weeks. To~     determine if galantamine (8 or 16 mg) is superior to placebo a) in reducing smoking~     self-administration in a human laboratory model and b) improving abstinence rates at the end~     of 4 weeks of treatment.~   "
128910|NCT01880086|"~     The purpose of this randomized controlled clinical trial is to evaluate the effects of~     clomiphene citrate compared to placebo (substance without active medication) in men who are~     taking pain medication (opioids) for chronic pain conditions and who have low blood~     testosterone levels.~      The condition of men having low testosterone with long-term pain medication (opioid) usage is~     called opioid-induced androgen deficiency (OPIAD). Low testosterone can be caused by pain~     medication effects on part of the brain (hypothalamic-pituitary axis) which ultimately result~     in decreased testosterone production by the testes. Typical symptoms of low testosterone~     (hypogonadism) may include decreased muscle mass, increased fat, osteoporosis, anemia,~     erectile dysfunction, delayed ejaculation. In addition, men with low testosterone may~     experience decreased attention, and decreased libido, fatigue, and depressed mood. Few~     studies have looked at hormonal changes caused by long-term opioid usage in men.~      Clomiphene citrate, a selective estrogen receptor modulator (SERM) oral medication which~     inhibits estrogen effects (feedback) on the brain, has been identified by prior studies to~     raise testosterone in men with low testosterone (due to reasons other than chronic pain~     medication). Clomiphene citrate is also known to lead to increased sperm production in men~     with low testosterone unlike testosterone topical or injection medications. Although~     clomiphene citrate has been studied in hypogonadal men with beneficial outcomes and minimal~     side effects, no group has previously studied clomiphene citrate as treatment in patients~     with OPIAD.~   "
128911|NCT01880073|"~     A thorough infertility evaluation commonly involves determining whether a woman's fallopian~     tubes are patent. The two most often utilized methods of evaluating the fallopian tubes are~     hysterosalpingogram (taking an X-ray of the pelvis after injecting dye through the uterus and~     fallopian tubes) and laparoscopic chromopertubation (a surgical procedure in which dye is~     visualized passing through the fallopian tubes).~      The FemVue Saline-Air device is a new method of assessing tubal patency. The device utilizes~     a mixture of saline and air bubbles that can be seen passing through the fallopian tubes by~     ultrasound. FemVue can be efficiently performed in a physician's office and is minimally~     invasive. Unlike hysterosalpingogram and laparoscopic chromopertubation, it does not carry~     the risks of anesthesia or surgery, and doesn't expose the patient to radiation or contrast.~     It does, like the other two methods, carry a small risk of infection.~      This study will involve using the FemVue device on patients under anesthesia in the operating~     room before they undergo scheduled laparoscopic chromopertubation, the gold standard for~     evaluating tubal patency. The two methods will be compared to determine the accuracy of the~     FemVue device.~   "
128912|NCT01880060|"~     Given the prevalence of overweight and obesity, worksite-based health promotion programs have~     been recommended due to their potential reach and social support impact. Within worksite~     contexts, many strategies to prevent and treat obesity have focused on educational programs~     delivered in person or to small groups that target knowledge acquisition and strategies~     targeted at individuals to improve their dietary and activity practices. These programs have~     been criticized because they typically reach a small percentage of workers—and seldom those~     that could benefit most, are of short duration, and have typically small effects that are not~     sustained. They have also typically been conducted in large worksites that have the greatest~     resources. The lack of success of these programs may be due to: 1) inadequate intervention~     intensity, 2) implementation challenges, and 3) a lack of theoretical models as the bases for~     intervention development. To overcome the limitations of previous research we will conduct a~     2 group randomized controlled trial to determine the reach and effectiveness of an extensive~     intervention that: (a) is based upon sound theory, (b) is delivered primarily through~     scalable interactive technologies, and (c) leverages the existing organizational and~     environmental context of the workplace.~   "
128913|NCT01880047|"~     Study rationale is based on the data that in previous clinical studies of eltrombopag in ITP~     there are some patients who have been reported as non responders at the maximal approved dose~     of 75 mg daily. The trend in both normal volunteers and in patients with ITP suggest and~     increasing response rate with increased doses of eltrombopag up to a dose of 75mg. Previously~     published data has shown no overt increase in toxicity in normal volunteers, oncology~     patients and aplastic anemia patients treated with escalated doses as high or higher than~     those proposed in this study.~      It therefore seems possible that in ITP patients who did not respond to a dose of 75mg daily,~     eltrombopag could be more effective at a higher dose. We propose a double blind randomized~     controlled trial in ITP patients who have been defined as non-responders at the maximum dose~     (75mg) of eltrombopag, assessing efficacy and toxicity at higher daily doses (100mg, 125 mg,~     150 mg)~   "
128924|NCT01879904|"~     Superficial rectal tumors could be removed by ESD with two major advantages showed by the~     literature: high rate of monobloc resection and R0 resection. Hence, recurrence rate was~     lower than ERM therapy. This technique is actually performed routinely in Japan and~     experience is limited in Europe, with few data in the literature.~      This study is suggested to patients with superficial medium or distal rectal tumors. The~     lesion was identified and demarcated using white-light endoscopy, magnifying endoscopy, and~     chromoendoscopy. Then, marking around the lesions was performed. Local injection was made~     using injection needle, and then mucosal incision was performed around the lesion using~     endo-knives. Submucosal dissection was performed using endo-knives. Hemostasis and vessel~     coagulation were practiced using primary hemostatic forceps during the procedure.~      Follow-up is one year. For lesion with invasive carcinoma (vessel and lymphatic involvement,~     undifferentiated, free margin less than 1 mm), a surgical resection is performed.~      All the patients have an endoscopic control 3 months after ESD (rectosigmoidoscopy with~     biopsies):~        -  For complete resection, an endoscopic control was performed at 1 year.~        -  For incomplete resection, another endoscopic therapy was attempted (EMR) an endoscopic~          control was performed at 1 year.~      At one year, patient with incomplete resection have a surgical resection.~   "
128914|NCT01880034|"~     Significant data exists to suggest that lipid emulsion administration in the setting of local~     anesthetic toxicity has the potential to be life-saving. Unfortunately, a variety of~     potential barriers exist to routine lipid emulsion administration for those performing~     regional anesthesia including drug availability, drug cost and drug location. Inadequate~     training or lack of established protocols also have the potential to negatively impact~     patient outcomes. A previous study by Toledo et al (Availability of lipid emulsion in United~     States obstetric units. Anesth Analg 2013;116:406-408.) evaluated lipid emulsion availability~     on obstetric units and found that it was nearly universally available.~      The Accreditation Council for Graduate Medical Education (ACGME) publishes a list of contact~     information for each anesthesia institution that engages in resident training. Investigators~     will contact these institutions by phone or email to obtain contact information for their~     regional anesthesia program director. In the absence of a program director, investigators~     will send a survey and consent information via email to the faculty physician most involved~     in regional anesthesia. Survey completion instructions (survey itself to be completed on~     Qualtrics Survey Hosting Service) and copy of the study consent form will be attached to the~     initial contact email. The study consent form will contain a description of the study itself.~     Survey participants will be allowed time to complete their survey in private at their~     discretion. Non-responders will receive two follow-up emails at one month intervals.~   "
128915|NCT01880021|"~     The purpose of this study is to determine whether synthetic hernia mesh materials undergo~     physical and/or chemical changes while in the body.~   "
128916|NCT01880008|"~     Glioblastoma is the most common primary malignant neoplasm of the adult brain. Even after~     multimodal therapy, outcomes remain poor, with a median survival of one year. Although~     advanced imaging methods have been suggested as molecular markers of prognosis and~     therapeutic response, these methods have not been validated for clinical use. In this~     exploratory, imaging-based, trial, thirty patients with a pathological diagnosis of~     glioblastoma will be followed prospectively for two years. The study examines how PET and MR~     imaging signals change following administration of a standard radio-chemotherapy treatment~     regimen to determine whether these imaging modalities can provide early indicators of~     response to therapeutic intervention. The investigators hypothesize that decreases in uptake~     of an investigational 18F-FLT PET tracer following treatment with radiation and chemotherapy~     will be a reliable predictor of glioblastoma response. In a more exploratory fashion, the~     investigators also will identify changes in diffusion and hypoxia MR imaging that may also~     correlate well with treatment response.~   "
128917|NCT01879995|"~     The mainstay of PKU treatment is a low-phenylalanine diet (i.e restriction of natural~     protein), and supplementation with a protein substitute (a mixture of amino acids free from~     phenylalanine, also containing micronutrients and vitamins) and special low-protein foods, to~     meet the patient's energy requirements. When diet and treatment is relaxed after childhood,~     adult and adolescent patients with phenylketonuria are at risk for malnutrition, depending on~     the compliance with treatment and the intake of amino acid supplements.~      In this study, nutrition status of patients with PKU and hyperphenylalaninemia is~     systematically assessed under ongoing current treatment, in relation to Phe-tolerance,~     compliance with treatment, and psychosocial issues.~      Study participants do not undergo any specific therapeutic or diagnostic intervention.~   "
128918|NCT01879982|"~     For the moment, the detection of a mood episode in Bipolar Disorder (BD) relies on the~     appearance of the first clinical signs that the clinician detect or that the patient becomes~     aware of and reports to the clinician. Since physiological parameters such as cardiac~     rhythms, respiratory rate, voice characteristics and actigraphy seem to be related to the~     onset of a mood episode, information collected through the combined monitoring of multiple~     selected physiological parameters (such as cardiac rhythms, respiratory rate, movements,~     voice) during wake and sleep time, using wearable user friendly systems included into~     garments as well as with a smartphone, may offer a new perspective in the long-term treatment~     of BD.~   "
128919|NCT01879969|"~     The specific aims of the study were to measure and compare the rates of alignment and cant~     reduction of the dental and facial midlines among the two groups.~   "
128920|NCT01879956|"~     Primary Objective:~      Efficacy of Occupational Therapy (OT) based Occupational Goal Intervention (OGI) in improving~     executive functions in patients with refractory schizophrenia as measured by the BADS.~      Secondary Objectives: improvement of functional aspects,basic and instrumental activities of~     daily living,negative symptoms and cognitive functions improvement~      Hypothesis: OT is more effective than control group to improve executive functions in~     patients with refractory schizophrenia.~   "
128921|NCT01879943|"~     The study will compare the diagnostic efficacy of the VCC (PillCam COLON 2) to standard~     colonoscopy in patients with prior colorectal surgery.~      The hypothesis is to validate the VCC as a means of screening for colonic polyps after~     resection, which would avoid a colonoscopy with its associated general anesthesia and~     potential side effects.~   "
128922|NCT01879930|"~     Chronic bladder pain syndrome is a chronic disabling disorder characterized by chronic pelvic~     pain, pressure or discomfort perceived to be related to the urinary bladder accompanied by at~     least one other urinary symptom such as persistent urgency or frequency in the absence of an~     identifiable cause. Chronic bladder pain syndrome severely decreases an individual's quality~     of life and represents a significant financial burden to those affected by it. Currently,~     multifactorial pathogenesis is assumed including endocrine-involvement, pelvic floor muscle~     irregularities, immunologic aspects and chemical causes. Corresponding to the wide spectrum~     of presumptive triggers, a large number of therapeutic approaches are propagated, however~     most are associated with limited effectiveness. Thus, treatment of BPS is a challenge and the~     ideal therapy remains to be elucidated. Microorganisms such as Chlamydia trachomatis,~     Ureaplasma urealyticum and Mycoplasma genitalium remains a challenge so that these organisms~     may well be involved in the pathogenesis of chronic bladder pain syndrome. The investigators~     hypothesise that doxycycline orally for 4 weeks, including therapy of the sexual partner, can~     significantly relieve symptoms in women with chronic bladder pain syndrome~   "
128923|NCT01879917|"~     The purpose of this study is to investigate the effect and safety of liraglutide 1.8 mg once~     daily compared to placebo for 52 weeks on change in beta-cell function in patients with newly~     diagnosed type 1 diabetes as an adjunctive therapy to insulin treatment.~   "
128925|NCT01879891|"~     The primary goal is to test the hypothesis high interval exercise increases energy~     expenditure and Insulin sensitivity more than 2 days of rest or moderate intensity exercise~     cumulatively over 23 hours during and following the exercise. Secondary goals are to evaluate~     exercise difficulty during moderate intensity exercise and high interval exercise as well as~     difficulty of activities of daily living and free living physical activity following rest,~     moderate intensity exercise and high interval exercise.~      A secondary study is designed to evaluate potential mechanism. Hypotheses are that changes in~     muscle lipid metabolism, mitochondrial function, fat and cellular insulin signals will be~     increased following the high intensity interval exercise. In addition, these changes will be~     related to changes in insulin sensitivity and increases in protein metabolism and muscle~     damage.~   "
128926|NCT01879878|"~     The goal of the POUDER trial is to determine the feasibility of a randomized controlled trial~     regarding the application of freeze-dried broccoli sprouts rich in sulforaphane and quercetin~     in patients with advanced pancreatic ductal adenocarcinoma that receive palliative~     chemotherapy.~   "
128927|NCT01879865|"~     Dexmedetomidine is an α2-adrenoceptor agonist that has only recently been registered for~     human use in Europe. It has sedative, analgesic and anxiolytic properties, but patients~     remain arousable. This makes it an ideal drug for procedures which require the patient to~     perform tasks, or for light sedation during procedures or in the Intensive Care Unit.~     Pharmacokinetic models of (anaesthetic) drugs can be used in target controlled infusions~     (TCI), to deliver stable plasma concentrations of drug during anaesthesia or sedation. There~     are several models available for dexmedetomidine at this time, but the most often used models~     (Dyck and Talke) underpredict the plasma concentration at higher concentrations. Also, plasma~     concentrations aren't what the clinician is interested in, but in the effect. Therefore,~     pharmacokinetic/pharmacodynamic (PKPD) models can be developed to titrate the drug to effect~     instead of plasma concentration, using TCI. This has been done for many anaesthetic drugs,~     but not for dexmedetomidine. Additionally, we want to investigate the effect of stimulation~     on the pharmacodynamic effect of dexmedetomidine. The reason for this is that patients under~     dexmedetomidine sedation are arousable by noises or touch. An operating room or ICU is never~     quiet, and there are always sounds of monitors, alarms, and talking between team members or~     activity around another patient in the same room, therefore the stimulation of the patient in~     such an environment may have a profound effect on the sedative effect of dexmedetomidine.~   "
128928|NCT01879852|"~     This is a single-center, randomized, single-blind (evaluator) study. Enrolled patients had a~     traumatic meniscal tear and underwent meniscectomy. The study included 6 weeks (12 visits) of~     standard or quadriceps intensive rehabilitation. The objective of the study was to determine~     the effect of quadriceps intensive rehabilitation on knee function and articular cartilage.~   "
128929|NCT01879839|"~     The aim of this study is to assess the effect of a diet prior to administration of contrast~     agent in terms of a preventive procedure which leads to an attenuation of the~     contrast-induced nephropathy (CIN).~      Patients with a known kidney disease are especially at risk. A potential beneficial effect of~     a diet prior to intervention has been shown in investigations in mammals, therefore this~     study will investigate if a pre-interventional diet in patients with known kidney disease and~     scheduled contrast agent examination can attenuate or prevent a post-interventional loss of~     kidney function.~   "
128930|NCT01879826|"~     The purpose of this study is to test if treatment with laser therapy in pediatric patients~     undergoing renal biopsies will improve patient satisfaction of the overall procedure. In this~     study, the participant will receive a laser acupuncture treatment targeting either kidney~     acupoints or targeting sham points not associated with the kidney; the participant will not~     get both. Both treatment sessions are given by a certified medical acupuncturist. The patient~     will still receive standard pain control protocols with anesthetic medications like lidocaine~     plus ketamine or fentanyl and versed during the biopsy, along with pain management after the~     procedure. All medication will be administered without regard for which group the participant~     has been randomized, as the treatment team will also be blinded.~      Hypothesis:~      We will test the hypothesis that treatment with laser acupuncture in patients undergoing~     renal biopsies will improve patient satisfaction of the overall procedure.~      Specific Aims:~      Specific Aim 1: Determine whether the use of laser acupuncture improves patient's overall~     satisfaction of renal biopsy.~      Specific Aim 2: Determine whether the use of laser acupuncture decreases the amount of~     sedative medication given during renal biopsy.~   "
128931|NCT01879813|"~     The study will explore the effects of a 6-week phospholipid drink intervention on the~     cognitive performance and physiological and subjective stress parameters of males following a~     repeated psychosocial/physical stressor.~   "
128932|NCT01879800|"~     The goal of this study is to 1) examine the feasibility and acceptability of a one-day~     Acceptance and Commitment Training + Illness Management (ACT-IM) intervention in patients~     with comorbid vascular disease risk factors and depression or anxiety; and 2) to evaluate the~     effectiveness of this brief group intervention(ACT-IM), compared to Treatment-As-Usual (TAU)~     on the mental health and functioning of patients with co-morbid mood/anxiety and vascular~     disease risk factors. Patients with vascular disease risk factors will be identified by~     physicians in Family Practice or Internal Medicine, through chart review, or through~     advertisements. Those with vascular risk factors will be screened and assessed for symptoms~     of depression or anxiety. Patients who are experiencing significant depressive or anxiety~     symptoms and are interested in the treatment arm of the study will be randomized to the~     ACT-IM intervention or to TAU. Assessments of the following will take place both before and~     after the intervention: depression, anxiety, functioning, illness self-management, blood~     vessel health, and blood.~   "
128933|NCT01879787|"~     This study aims to evaluate systematically and controlled the effectiveness of mental~     practice techniques and modified constraint- induced movement therapy (mCIMT)in the treatment~     of post-stroke patients with motor deficit in the upper limb. As well as finding a protocol~     of transcranial direct current stimulation(tDCS)that will maximize the effects of the~     practice of mental image and mCIMT. To this end, the subjects included will be submitted to~     12 therapy sessions with active or sham tDCS combined with at least one of the following~     techniques: conventional physiotherapy, mental practice technique or mCIMT~   "
128991|NCT01879020|"~     The purpose of this study is to assess the safety, tolerability, pharmacokinetics and~     pharmacodynamics of TA-8995 after multiple doses in healthy adult male subjects~   "
128934|NCT01879774|"~     The aim of this epidemiological study is to characterize the neuropsychological and motoric~     performance in patients with hyponatremia. Newer studies revealed an association between mild~     hyponatremia and unstable walking, frequency of falls and risk of a fracture, questioning the~     paradigm of an asymptomatic hyponatremia. Until now, there is no known detailed~     investigation and characterisation of the cognitive and motoric performance or limitation by~     this disorder. Therefore this study will investigate patients with hyponatremia on the basis~     of neuropsychological and neurological tests.~   "
128935|NCT01879761|"~     The purpose of this study is to determine how monocyte HLA-DR and other markers of immune~     function change with time in patients with and without prior immune dysfunction who survive~     sepsis from Staphylococcus aureus bacteremia.~      We hypothesize that patients with prior immune dysfunction will have greater reductions in~     HLA-DR and other markers of immune function after an episode of sepsis than people who do not~     have prior immune dysfunction.~   "
128936|NCT01879748|"~     This study is designed to evaluate the pharmacokinetics of rasagiline in healthy Japanese and~     Caucasian subjects after single and multiple doses of rasagiline.~   "
128937|NCT01879735|"~     We wish to develop a protocol for PET/CT examination of humans using the bile acid tracer~     11C-cholylsarcosine. This is done by a series of PET/CT examinations of healthy humans and~     patients with cholestatic disorders.~   "
128938|NCT01879722|"~     The purpose of this study is to characterize the safety and tolerability of TAK-063 when~     administered as multiple oral doses at escalating dose levels in participants with stable~     schizophrenia and in healthy Japanese participants.~   "
128939|NCT01879709|"~     Cognitive impairment is a key disabling feature of SZ. The impairment affects functional~     outcome and employability, resulting in increased burden. Currently, medications offer only~     modest benefits for the cognitive dysfunction. Hence, non-pharmacological interventions are~     worth consideration. Yoga is known to enhance cognitive abilities in healthy persons. Our~     preliminary studies have shown for the first time that there may be remarkable improvement in~     selected cognitive domains among outpatients with SZ. The improvement is unlikely to be due~     to rater bias, as they were noted using a computerized neurocognitive battery. Since our~     preliminary studies involved an open trial, it is necessary to conduct more controlled~     studies. To evaluate our results further, we propose to test the effectiveness of yoga~     supplementation using a controlled single blind design in India. Outpatients with SZ (N=258)~     undergoing treatment at a large academic center in New Delhi, India will be randomly assigned~     to one of the three groups- yoga training (YT, N=86), physical exercise (PE, N=86) or~     treatment as usual (TAU, N=86). The YT group will undergo 21 days yoga supplementation, while~     the PE group will complete a 21 day systematic physical exercise training regime. The third~     group will have no such supplementation. Cognitive state, symptom severity and overall~     function will be assessed at four time points: just before, immediately after, three months~     later and six months after completion of YT/PE supplementation. The evaluations will be~     conducted by raters blind to group status.~      Hypotheses:~        1. Yoga enhances attention, as well as related cognitive function among persons with~          schizophrenia.~        2. Yoga has beneficial effects on the short term functional outcome of schizophrenia~   "
128940|NCT01879696|"~     The proposed study is a double-blinded, randomized clinical trial of tissue pressure~     monitoring only (Control group) vs. tissue pressure monitoring plus tissue ultrafiltration~     (Treatment group) in patients with tibia fractures presenting to the trauma or emergency~     departments at participating clinical sites. Tissue ultrafiltration refers to the removal of~     muscle interstitial fluid by the ECSPRESS PMFC. The primary objective of the study is to~     demonstrate whether the removal of interstitial fluid by the ECSPRESS PMFC/FC catheters~     decrease the incidence of fasciotomy in the Treatment group when compared to the Control~     group. Fasciotomy was chosen as the primary outcome because it is clearly defined and~     clinically relevant; reduction of fasciotomy is of clear clinical benefit. Enrolled patients~     may have isolated tibia fractures OR be multiple trauma patients (those with another major~     fracture in a different body region or two distinct body system injuries, excluding those~     with injuries to the opposite leg that would preclude them from completing required tests).~   "
128941|NCT01879683|"~     The purpose of the study is to evaluate if LiRIS 400 mg is safe and tolerable when~     administered to women with Interstitial Cystitis with Hunner's lesions, and to evaluate any~     change in the bladder or in IC symptoms, following LiRIS administration.~   "
128942|NCT01879670|"~     Heart failure is a common condition, and the number of people with advanced disease continues~     to increase. We need new treatments that improve patients' symptoms and extend life. Recently~     the new CircuLite Synergy pump has come into use. It is the smallest pump manufactured to~     date and does not cover the full work of the heart, instead providing partial support. One~     interesting thing about this is that taking some strain off the heart might allow the muscle~     to repair and rebuild its own strength. This process is called reverse remodelling, and is~     the topic of this research. Our hypothesis is that partial support improves patients'~     symptoms and causes improvement in heart muscle function. We also want to examine the best~     techniques for assessing this, including new scanning and molecular tests, and study some~     practical aspects of the pump to do with blood clotting.~   "
128943|NCT01879657|"~     To evaluate the concordance and discordance between results of 68Ga-DOTATATE PET-CT scan and~     OctreoScan ® which is considered standard of care diagnostic test for neuroendocrine cancers~     and other imaging modalities like CT scan/MRI as gold standard.~   "
128944|NCT01879644|"~     Neurofeedback has proved to be effective in treating Attention deficit hyperactivity disorder~     (ADHD) in experimental settings. This study investigates whether neurofeedback can be used as~     a therapeutic intervention in regular outpatient care. The investigators compare high~     frequent neurofeedback with high frequent self-management therapy and suppose that both~     result in comparable effects.~   "
128945|NCT01879631|"~     Keratoconus is a progressive ectatic disorder that steepens the cornea resulting in a conical~     shape. Radial Keratotomy can provide an optical rehabilitation by its flattening effect. It~     can also halt the progression of disease owing to fibrotic activation in perpendicular~     corneal incisions.~   "
128946|NCT01879618|"~     The study will determine if the Fragmin dose can be adjusted to suit the clinical needs of~     patients during dialysis.~   "
128947|NCT01879605|"~     This study investigated the effect of preoperative bowel preparations for patients undergoing~     spinal fusion surgery.~   "
128948|NCT01879592|"~     Asthma and sickle cell disease each are serious medical problems. People with asthma have~     difficulty breathing, wheeze (a whistling noise when breathing), cough, produce sputum or~     phlegm, and have inflammation (swelling, irritation, redness) and narrowing of the bronchial~     tubes.~      When a person has both asthma and sickle cell disease together, more serious medical problems~     can occur such as having acute chest syndrome and pain episodes more often. It is sometimes~     hard to diagnose asthma in a person with sickle cell disease because sickle cell disease can~     also cause lung problems.~      The purpose of this study is to see if the investigators can better understand asthma when it~     occurs in a person who has sickle cell disease. The investigators will do this by taking a~     blood, urine, and saliva sample. The blood and urine samples will be analyzed for chemicals~     and DNA (genes). Certain genes can cause patients to have sickle cell disease or asthma. The~     investigators will use the saliva sample for future studies to compare the results from the~     blood testing with saliva. The investigator's long-term goal is to make sure people who have~     asthma and sickle cell disease are getting the best asthma treatments. The investigator's~     hypothesis is that the analysis of the blood, urine and saliva using a method called,~     metabolomics, may identify a unique asthma signature in children with sickle cell disease~     which may lead to targeted treatments.~   "
128949|NCT01879579|"~     The purpose of this pilot study is to determine whether text message (and phone)~     communication can be effectively utilized to adjust long-acting insulin, compared to standard~     practice.~   "
128950|NCT01879566|"~     The aim of this prospective single-center study is to evaluate sympathetic nervous system~     directly measured by microneurography, 24-hour blood pressure, endothelial function, vascular~     compliance, quality of life and platelet adhesion in patients with sleep apnea syndrome~     (defined by a complaint of excessive daytime sleepiness, an Epworth sleepiness score>8[10],~     and an apnea/hypopnea index (AHI>15/h) before and after catheter-based radiofrequency~     ablation of renal nerve. If the selected patients are treated with CPAP, this therapy should~     be stable during the whole study time. Primary and secondary end-point will be measured~     before and 1, 3, 6 and 12 months after renal sympathetic denervation.~   "
128951|NCT01879553|"~     The present study is designed to confirm the safety and immunogenicity of trivalent, surface~     antigen, inactivated influenza vaccine in 2 age cohorts: 18 to ≤60 years and ≥61 years.~      For the immunogenicity endpoint the antibody response to each influenza vaccine antigen will~     be evaluated by means of Single Radial Hemolysis (SRH) or Hemagglutination Inhibition (HI) at~     approximately 21 days post vaccination.~      The vaccine composition will be based on the WHO-recommended influenza strains for the~     2013/2014 Northern Hemisphere vaccine, and the results of this study are intended to support~     the use of this vaccine in future influenza seasons if the recommended vaccine composition~     remains the same, in compliance with the requirements of the current European Union (EU)~     recommendations for clinical trials related to yearly licensing of influenza vaccines.~   "
128952|NCT01879540|"~     The present study is designed to confirm the safety and immunogenicity of trivalent, surface~     antigen, inactivated influenza vaccine including MF59C.1 adjuvant, formulation 2013/2014~     Northern Hemisphere, in adults ≥65 years of age.~      For the immunogenicity endpoints the antibody response to each influenza vaccine antigen,~     will be measured by means of Single Radial Hemolysis (SRH) or Hemagglutination Inhibition~     (HI) at approximately 21 days post immunization.~      The vaccine composition will be based on the World Health Organization (WHO) recommended~     influenza strains for 2013/2014 Northern Hemisphere.~      The results of this study are intended to support the use of this vaccine in future influenza~     seasons if the recommended vaccine composition remains the same, in compliance with the~     requirements of the current European Union (EU) recommendations for clinical trials related~     to yearly licensing of influenza vaccines.~   "
128953|NCT01879527|"~     Following acute inflammation of the optic nerve region, as commonly seen in multiple~     sclerosis patients, the optic nerve often undergoes atrophy, thus representing permanent~     damage. Data from animal studies suggest that amiloride may prevent this process. The aim of~     this study is to assess a potential neuroprotective effect of amiloride in acute autoimmune~     inflammation of the optic nerve region.~   "
128954|NCT01879514|"~     IgA nephropathy(IgAN) is the highest incidence of kidney pathology in the primary~     nephropathy. In terms of differences in prognosis, severe IgA nephropathy,one of the most~     main primary renal disease,could cause the uremia. It will be significant that early~     indicators of prognosis and early intervention can be normalized and the scientific criteria~     for judging the efficacy of great clinical can be established. The subject based on the past~     study,literature research and various treatment will take the method of multi-center,~     double-blind, randomized, control to investigate the standard treatment of severe IgA~     nephropathy. Otherwise the uniformity and objectivity of Traditional Chinese Medicine (TCM)~     will be improved by the standardization of TCM research based on the epidemiological~     investigation and statistical analysis. The subject will determine the efficacy of more~     sensitive biomarkers and establish more scientific criteria for judging the effect with the~     application of urine proteomics and metabolomics technologies in order to operate in the~     formation of the standardization program of the treatment of severe IgA nephropathy with the~     Integrative medicine of TCM.~   "
128955|NCT01879501|"~     The need for low vision services (LVS) will increase exponentially over the coming years due~     to the anticipated and exponential growth in the ageing population in Singapore and a rise in~     chronic non-communicable eye diseases. Finding the best evidenced-based management for~     chronic eye diseases contributing to low vision (LV) is therefore crucial. Improving patient~     responsibility is the key to managing LV effectively.1 This means achieving optimum self~     management (SM).2 However, there are currently no LV SM programs in Singapore and none has~     been evaluated using a randomized controlled trial (RCT) design, the gold standard methods to~     evaluate health interventions.~      The aims of this study are to assess the effectiveness of the 'Living Successfully with Low~     Vision (LSLV)' program in improving quality of life (QoL) in 160 elderly people with LV~     attending the Singapore National Eye Centre (SNEC) LV clinic. Of these, 80 will be randomly~     allocated to receive the LSLV 4-week SM program while the remaining 80 will receive the usual~     care. Comparisons will be made to determine the efficacy of the LSLV program. QoL,~     self-efficacy, emotional well being, and vision-specific distress will be assessed 2 weeks~     after training, and at six months and 12 months post intervention.~      This study will be the first evidenced-based RCT investigating the effectiveness of a novel~     vision-specific self-management strategy to improve QoL. It will also adopt a longitudinal~     design where the effectiveness of these interventions will be evaluated at 12 months-the~     first follow-up assessment of that duration at both national and international levels.~     Furthermore this will be the first study to characterize and profile the patients where the~     effect of the program did not demonstrate an improvement in both primary and secondary~     outcomes six months after its completion. The future clinical implications of this study~     include the potential to implement a successful model of LV rehabilitation in other tertiary~     centres around the country.~   "
128956|NCT01879488|"~     Controlling the respiratory pattern of mechanically ventilated patients in volume control~     mode is recommended during nebulization. No studies looked into conditions of nebulization~     during assisted mechanical ventilation to define the optimal nebulization technique and its~     effect on pulmonary deposition.~      The aim of this study is to analyse the effect of ventilation mode (barometric versus~     volumetric) on deposition by planar scintigraphy during mechanical ventilation.~   "
128957|NCT01879475|"~     The effectiveness objective of this study is to evaluate whether 032-11 is non-inferior to~     Floseal as an adjunct to achieving haemostasis during surgical procedures involving cardiac~     and aortic thoracic surgery.~   "
128958|NCT01879462|"~     GSK2878175 is a site IV NS5B non-nucleoside inhibitor (NNI) being developed for the treatment~     of chronic HCV infection. This study represents the first administration of GSK2878175 in~     humans to define safety, tolerability, and pharmacokinetics (PK) following single and repeat~     doses of GSK2878175 in healthy subjects.~      This is a Phase 1, randomized, single-blind, placebo-controlled, dose escalation study to~     determine the safety, tolerability, and PK profile of GSK2878175 in single (Part 1) and~     repeat doses (Part 2) in healthy subjects. In addition the study will explore the effect of a~     moderate (30%) fat meal on single dose PK endpoints in healthy subjects.~   "
128959|NCT01879449|"~     The purpose of the study is to conduct a feasibility survey of the prevalence of spasticity~     at a single long-term care facility for veterans and their spouses in Murfreesboro,~     Tennessee. These data will be used to strengthen a future grant application to the Department~     of Defense in response to their ongoing Traumatic Brain Injury initiative.~   "
128960|NCT01879436|"~     Maternal malignancy during pregnancy is estimated to occur in 1 out of 1000 pregnancies.~     Controversy exists regarding the effect of pregnancy on cancer prognosis. Gestational~     hormones and pregnancy-related growth factors may induce a more aggressive behavior in~     malignant cells. However, metastasis to the products of conception is rare. In the current~     study investigators wish to analyze the effect of placental explants on cancer cells~     (cervical, ovarian, thyroid, melanoma, lymphoma, leukemia and breast)phenotype (cell death,~     proliferation, migration , invasion), signaling pathway, mRNA, miRNA and protein expression.~   "
128961|NCT01879423|"~     This is a single dose, open-label, randomized, two-period crossover study to demonstrate the~     bioequivalence of lamotrigine dispersible/chewable tablets (5mg×5) and lamotrigine compressed~     tablets (25mg) in healthy Chinese male subjects in fasting conditions. The safety,~     tolerability and pharmacokinetic profile of lamotrigine dispersible/chewable tablets will~     also be assessed.~   "
128962|NCT01879410|"~     Umeclidinium/vilanterol (UMEC/VI) is a combination product under development that is used for~     the treatment of airflow obstruction in patients with COPD. Fluticasone propionate/salmeterol~     (FSC) is an approved drug that is already in use for the treatment of COPD. This is a~     multicenter, randomized, double-blind, double-dummy, parallel group study to evaluate the~     efficacy and safety of UMEC/VI 62.5/25 microgram [mcg] once daily administered via Novel Dry~     Powder Inhaler (NDPI) compared with fluticasone propionate /salmeterol (FSC) 250/50 mcg~     twice-daily when administered via ACCUHALER/DISKUS inhaler over a treatment period of 12~     weeks in subjects with COPD. Eligible subjects will be equally randomized to UMEC/VI 62.5/25~     mcg or FSC 250/50 mcg for 12 weeks. A safety follow-up assessment will be conducted~     approximately 7 days after the end of the study treatment.~   "
128963|NCT01879397|"~     Pilot prospective two group observational study to create a model of the carotid plaque~     composition based on ultrasonic backscattered signals and select clinical data.~   "
128964|NCT01879384|"~     Microdialysis is admitted to be reliable by numerous surgeons to monitor flaps. Nevertheless,~     a few authors reported follow up with microdialysis in bone flaps, and they all described the~     position of the catheter in the surrounding soft tissue muscle. This surrounding soft tissue~     is not always the reflect of bone vascularisation.~      The aim is to study the feasibility of a follow up of microanastomosed bone flaps with~     microdialysis. To reach this goal, investigators perform a clinical prospective research~     project untitled MTM project~   "
128965|NCT01879371|"~     To investigate the relative bioavailability of ibuprofen from a (FDC) film-coated tablet of~     ibuprofen and caffeine vs. a tablet of ibuprofen (Brufen®) and a tablet of ibuprofen lysinate~     (Nurofen Immedia®).~   "
128966|NCT01879358|"~     The aim of the Danish Organization for Randomized Trials with Clinical Outcome (SORT OUT) is~     to compare the safety and efficacy of the sirolimus eluting ORSIRO stent and the~     biolimus-eluting NOBORI stent in a population-based setting, using registry detection of~     clinically driven events~   "
128967|NCT01879345|"~     Single centre, double-blind, randomised, placebo-controlled study of two dosage regimens of~     BIA 2-093 - 1800 mg (Group 1) and 2400 mg (Group 2) - in two groups of healthy male~     volunteers~   "
128968|NCT01879332|"~     Randomized, double-blind, placebo-controlled, sequential multiple ascending dose study to~     determine a maximum tolerated dose~   "
128969|NCT01879319|"~     The primary objective of this study was to assess users' ability to administer a full dose of~     evolocumab in a home-use setting using either an automated mini-doser (AMD) or~     autoinjector/pen (AI/pen).~   "
128970|NCT01879293|"~     Cardiovascular disease is the most common cause of death in the world. Most of the attention~     in treating ischemic heart disease (IHD) is understandably directed toward treating coronary~     artery disease. However there are other treatable culprits in these patients.~      Left ventricular hypertrophy (LVH) is widespread in IHD patients, even in the absence of~     hypertension. It is a strong predictor of cardiovascular events and all-cause mortality. In~     one study, the presence of LVH was a stronger predictor of mortality than either multivessel~     cor-onary disease or impaired LV function.~      Metformin is an antihyperglycemic agent with a history of successful use in type 2 diabetes.~     In the UKPDS (United Kingdom Prospective Diabetes Study), metformin was associated with a 39%~     lower risk of myocardial infarction compared with conventional therapy. Metformin also~     offered dual benefits of improving vascular function and lessening ischemia in nondiabetic~     patients.~      Hence, the main aim of this study was to assess whether metformin could regress LVM in~     patients with IHD. The secondary aim was to assess the effect of metformin on LV volumes and~     endothelial function in this patient group.~   "
134872|NCT01801943|"~     The purpose of this study is to determine the effects of a coordinated intervention of~     cognitive remediation training (CRT) and walking intervention on cognition and gait in the~     elderly.~   "
128971|NCT01879280|"~     The scientific objectives of this study are to systematically study the problems that are~     created by incising the attachment of the temporalis muscle in a randomized group of~     patients, and to determine whether another approach that does not detach the temporalis~     muscle results in less post-operative morbidity. Cutting through the attachment of the~     temporalis muscle to the skull is a widely-accepted procedure used to gain access to the~     skull prior to the drilling used for a pterional craniotomy (one of the most frequent types~     of surgeries used in neurosurgical practice). Despite the frequent use of this maneuver and~     the known sequelae of temporalis mobilization (e.g. post-operative myofascial pain,~     temporalis weakness, and pain with mastication), very little is known about the true~     incidence of these post-operative symptoms. Furthermore, there is very little objective~     evidence at the present time to support the claim that the incidence and severity of these~     post-operative phenomena can be decreased with use of an osteoplastic craniotomy (a procedure~     where the temporalis is left attached to the bony calvarium). The investigators would like to~     evaluate whether this slightly more time-consuming and technically demanding approach is less~     morbid in this respect than the contemporary pterional approach. Special note is made that~     the osteoplastic approach has been used in standard neurosurgical practice for quite some~     time.~   "
128972|NCT01879267|"~     Huntington's disease (HD) is an incurable and fatal disorder characterised by progressive~     degeneration of the basal ganglia and the cerebral cortex. Contrary to earlier thinking, HD~     is associated with abnormalities in peripheral tissues which might even contribute to brain~     pathology including muscle wasting, mitochondrial abnormalities, and impaired muscle energy~     metabolism. Mitochondrial impairment and muscle atrophy in human HD patients and murine~     models of HD are associated with altered expression of PGC-1a, a transcriptional cofactor~     that seems to regulate many, if not all of the adaptations of muscle fibres to chronic~     endurance training, and induces improved exercise performance and increased peak oxygen~     uptake. We aim at investigating whether endurance exercise has the capability of stabilizing~     and / or reversing PGC-1a dependent alterations of muscle function and structure in HD~     patients, and whether muscle training ameliorates musculoskeletal and cardiovascular~     function, as well as motor and cognitive symptoms in HD patients.~   "
128973|NCT01879254|"~     For this human research, 17 treatment-refractory OCD patients who already received DBS~     implants for treatment refractory OCD between June 1998 and October 2007 will be included.~     New patients that complete the protocol on refining the target for DBS in OCD will be~     included in this follow-up study as well. They will be psychiatrically evaluated on regular~     bases: at least twice yearly in the years two to five after surgery, at least once a year for~     the years thereafter. The duration of this protocol is indefinite, but spans at least 10~     years. The main aim of this study is to investigate the long-term effect of DBS in OCD~     patients.~   "
128974|NCT01879241|"~     The primary objective of the trial is to investigate the survival time (the time from~     randomization until death or end of the trial) compared between control group and~     experimental group.~      This is a prospective, multicenter, randomized, stratified, parallel-group, double-blind~     trial comparing placebo with 1 mg/d rasagiline as add-on therapy to 100 mg riluzole in~     amyotrophic lateral sclerosis (ALS) in 250 enrolled patients. For entry, the El Escorial~     Criteria for the diagnosis of ALS will be used. The patients have to be stable on riluzole at~     least 4 weeks prior to randomization.~   "
128975|NCT01879228|"~     In recent years, diabetes has emerged as one of the most significant co-diseases that many~     Cystic Fibrosis (CF) patients develop. Type 1 and Type 2 diabetes results when either the~     body does not make enough insulin or the body does not respond correctly to this insulin.~     Insulin is a hormone which is made by cells in the pancreas and helps carry glucose (sugar)~     from the food we eat to the cells of the body for energy. While cystic fibrosis related~     diabetes (CFRD) has many features similar to both Type 1 and Type 2 diabetes, it is very~     different; therefore, treatment and care of CFRD is not the same.~      The purpose of this research study is to examine and understand the various mechanisms that~     contribute to CFRD and gain a better understanding of potential means to treat CFRD. The~     primary objective is to determine effectiveness of chronic incretin-based therapy vs. placebo~     on insulin secretion in CF patients with indeterminate glucose tolerance, impaired glucose~     tolerance, or CFRD.~   "
128976|NCT01879215|"~     This study will utilize T1-Rho MRI to evaluate the effect of intramedullary nailing on~     patellofemoral articular cartilage when the surgery is performed using the infrapatellar vs.~     the suprapatellar approach. Subjects will be randomized to one or the other standard care~     surgical approaches.~   "
128977|NCT01879202|"~     Fatigue is a common symptom in multiple sclerosis (MS) that is characterized by physical~     and/or mental exhaustion. Fatigue is difficult to treat and treatment efficacy of available~     therapy is limited. The goal of this study is to determine whether MS-associated fatigue~     improves after 6 weeks of methylphenidate therapy. Treatment efficacy will be measured by a~     questionnaire called Fatigue Severity Scale (FSS).~   "
128978|NCT01879189|"~     In order to better communicate personal risk of breast cancer to women who have not yet~     initiated breast cancer screening (mammography), The Annenberg School of Communication at the~     University of Pennsylvania has created a personal breast cancer screening decision aid tool.~     This tool will be pilot tested, and then implemented and tested in nine primary care and~     OB/GYN practices within the University of Pennsylvania Health System.~   "
128992|NCT01879007|"~     This study seeks to compare the pharmacokinetic characteristics of Factive 200mg Intravenous~     Formulation (Gemifloxacin 200mg) with those of Factive 320mg Tablet Formulation (Gemifloxacin~     320mg) and to explore possibility of clinical use of the IV formulation.~   "
129011|NCT01878760|"~     The aims of the APRICOT study are:~        -  To establish the incidence of severe critical events in children undergoing anesthesia~          in Europe.~        -  To describe the differences in paediatric anaesthesia practice throughout Europe.~        -  To study the potential impact of this variability on the occurrence of severe critical~          events (Laryngospasm, Bronchospasm, Pulmonary aspiration, Drug error, Anaphylaxis,~          Cardiovascular instability, Neurological damage, Perianaesthetic cardiac arrest and~          postanaesthetic Stridor).~   "
129284|NCT01875159|"~     The purpose of this pilot study is to document the extent to which intermittent hypoxia~     persists beyond the age of discontinuing clinical methylxanthine, and will assess the effect~     of caffeine treatment on the number of intermittent hypoxia episodes and the total number of~     seconds with a hemoglobin oxygen saturation (HbO2 SAT) below 90%.~   "
128979|NCT01879176|"~     Cardiopulmonary bypass (CPB) surgery initiates a systemic inflammatory response induced by~     extrinsic (e.g. anesthesia, contact activation within the extracorporeal circuit,~     endotoxemia) and intrinsic (e.g. tissue damage, endothelial cell activation,~     ischemia-reperfusion injury of myocardium) factors. Monocytes are important players in~     systemic inflammation and the main producers of pro- and antiinflammatory cytokines.~     Monocytes activated by the extracorporeal circuit lead to a dysregulation of inflammatory~     homeostasis, increased levels of proinflammatory plasma mediators such as TNF-a, IL-1β, IL-6~     and IL-18 are joined by antiinflammatory cytokines such as IL-10. This strong inflammatory~     response induces post surgical monocyte immunosuppression which is indicated by an impaired~     production of ex vivo LPS induced TNF-a production. Also malfunction of the peripheral~     circulation with increased lactate levels, pronounced fluid accumulation, increased need of~     vasopressors and cerebral dysfunction are observed. All of these factors may delay weaning~     from the ventilator, recovery of organ functions and discharge from ICU. Thus measures to~     decrease the inflammatory process have the potential to improve the perioperative course.~      Use of cytokine adsorbing circuit during CBP has an effect on circulation cytokine levels for~     the first 36 hours after surgery and induces a decreased inflammatory response for up to 3~     days post surgery.~   "
128980|NCT01879163|"~     This is a Phase I trial to evaluate the safety and immunogenicity of MVA85A-IMX313~     vaccination compared to MVA85A vaccination, in BCG vaccinated adults.~   "
128981|NCT01879150|"~     Single center, open-label, single arm, pilot study designed to evaluate safety, tolerability~     and efficacy of CYCLAPLEX device, a minimal invasive enhanced suture and button implant and~     surgery tools for correction of inter-metatarsal angle in subjects suffering from mild to~     moderate Hallux Valgus deformity~   "
128982|NCT01879137|"~     the purpose of the study is to investigate whether arginine infusion is a new tool to~     differentiate patients with diabetes insipidus, primary polydipsia and healthy subjects.~   "
128983|NCT01879124|"~     The purpose of this study is to evaluate the prognostic performance of intrarenal resistive~     index in the first years after kidney transplantation on graft function and on patient and~     graft survival. In addition, the determinants of the intrarenal resistive index, including a~     detailed analysis of the relation between graft histology and the intrarenal resistive index,~     will be assessed.~   "
128984|NCT01879111|"~     Out-patients with coronary heart disease or hypertension will fill out a depression screening~     questionnaire while waiting in a cardiac clinic. Using a randomised-controlled study design~     half of the patients will receive a patient-targeted written screening feedback. This~     feedback contains information about depression in general, depression-severity adapted~     treatment guidelines and contact-information for treatment. Patients in the control group~     receive no direct screening-feedback but their cardiologist will be informed about the~     screening result. All patients with a positive screening-result will be contacted after one~     month and six months and asked for symptoms of depression, and their use of health care. The~     aim of this study is to evaluate the efficiency of this minimal intervention on the course of~     depressive symptom in patients with known coronary heart disease or hypertension.~   "
128985|NCT01879098|"~     The purpose of this research study is to determine whether a probiotic can change the way~     bile is used by the body. The investigators will also look at the effect of the probiotic on~     your intestinal health.~   "
128986|NCT01879085|"~     This is a Phase Ib/II experimental, open-label, dose escalation, active treatment study~     designed to determine the safety, tolerability, and recommended dose of the combination.~      During the Phase 2 portion of the study, we will assess progression-free survival (PFS),~     overall survival (OS),overall response rate (ORR), correlative endpoints, DNA methylation~     measured by microarray, and expression level of the genes as measured by microarray~   "
128987|NCT01879072|"~     The goal of this protocol is to establish a cohort of at least 1500 biologic samples~     collected prospectively from patients treated in BMT CTN centers that will be a shared bio~     specimen resource for conducting future allogeneic hematopoietic stem cell transplantation~     (HCT) correlative studies.~   "
128988|NCT01879059|"~     The effects of physical inactivity on variations in blood glucose and vascular health are not~     fully understood. The purpose of this study is to determine if an acute transition from~     physical activity to inactivity alters vascular health. Specifically, the investigators wish~     to examine in healthy, lean physically active individuals (obtaining greater than 10,000~     steps/day) if decreasing physical activity (obtaining less than 5,000 steps/day) will alter~     blood flow following a meal a marker of vascular health. Furthermore, the investigators wish~     to examine if a one day return to physical activity (obtaining >10,000 steps/day) can restore~     the detrimental effects on blood flow following a meal.~   "
128989|NCT01879046|"~     Articular cartilage can be the seat of many diseases including osteoarthritis and traumatic~     defaults. The cartilage has no intrinsic ability to repair resulting at long term in function~     loss in the joints. Currently available treatments are not satisfactory in the long term, the~     use of mesenchymal stem cells appears to be promising due to their ability to multipotency~     and immunomodulation properties. This project aims to determine the most appropriate source~     for regenerative medicine of cartilage stem cells from tissue taken during arthroplasty in~     patients with osteoarthritis. These cells will be tested for different chondrogenic markers.~     The success of this project will consider the implementation of a strategy for regenerative~     medicine in bone and joint diseases.~   "
128990|NCT01879033|"~     Childhood obesity is perhaps the most significant public health problem in the most developed~     countries and is rapidly becoming so in developing countries. National Health and Nutrition~     Examination Survey data shows a 3-fold increase in the prevalence of obesity in childhood,~     over past few decades. Furthermore, childhood obesity has markedly contributed to the~     prevalence of the metabolic syndrome and type 2 diabetes in U.S. children. Alarmingly, there~     is increasing evidence that atherosclerosis develops silently during childhood in obese~     children. In the Bogalusa Heart Study, pediatric autopsy studies showed a clear relationship~     between the number and severity of risk factors, principally obesity, with atherosclerosis in~     both the aorta and coronary arteries. Increased intimal medial thickness (IMT) was not~     present among obese adults who had been normal weight as children, emphasizing the cumulative~     effects of childhood obesity persisting into adulthood. Thus, the need for primary prevention~     of cardiovascular disease beginning in childhood is strongly suggested.~   "
128993|NCT01878994|"~     Objectives: To evaluate the effectiveness of the Nereu program compared to standard care~     (advice on increased physical activity and nutrition) such as a health intervention tool for~     the childhood obesity management~      Methods/Design: The study design is a randomized controlled multicenter clinical trial using~     two types of treatment. Population and sample: Children 6 to 12 years with overweight or~     obesity, according to the z score of body mass index (BMI z) >= 1 for age and gender defined~     by International Obesity Task Force (IOTF). It is considered necessary to recruit 100~     children: 50 control group (CG) and 50 Intervention (IG). Study Intervention: Nereu Group: 8~     month intervention with 3 weekly training sessions doing physical exercise for children and a~     weekly session for parents of physical activity and healthy eating habits and behaviour~     strategies, that involves both parental and child participation. The control group will~     receive a monthly session of healthy physical and eating habits. Main Outcome Measures:~     Improvement of BMI z, physical activity and nutrition habits, behaviour components and~     quality life related to health at the end, 6 and 12 months after intervention.~   "
128994|NCT01878981|"~     To generate real world evidence to compare clinical outcomes and patient health-related~     quality of life, resulting from catheter ablation therapy with clinical outcome and patient~     health-related quality of life resulting from drug therapy in China. An economic model will~     be constructed, and using the clinical events evidence collected in this study, and China~     long-term disease progression and local disease cost data to perform a cost-effectiveness~     evaluation of Catheter Ablation versus Drug Therapy in AF (Paroxysmal plus Persistent AF)~     patients.~   "
128995|NCT01878968|"~     There is evidence to suggest that patients make different end-of-life decisions if they~     understand the risks, benefits and alternatives of CPR and mechanical ventilation. This study~     will examine whether evidence-based informed consent impacts patients choices and healthcare~     outcomes compared to routine care.~   "
128996|NCT01878955|"~     AMH is a member of the transforming growth factor family. It is produced by the granulosa~     cells from 36th weeks of pregnancy.Ovarian granulosa cells are the only source of the~     antimüllerian hormone. AMH production continues until response to exogenous FSH occurs and~     follicles reach 4-6 mm in diameter.The number of follicles in patients with polycystic~     ovaries are 2-6 times higher than normal women. Serum AMH levels are 2-3 times higher in~     patients with PCOS. The cause of elevated serum AMH levels in patients with PCOS is unknown.~     There are data showing elevated serum AMH level is due to the increase in the number of~     follicles 2-8 mm in diameter. Although there is no precise definition; multicystic ovarian is~     defined by the presence of more than six follicles 4-9 mm in diameter and mixed~     morphologically with PCO. PCO and multicystic ovaries are distinguished by the absence of the~     increase in stroma / volume.The aim of this study is to investigate whether there is a~     difference of serum AMH levels between patients with PCO or multicystic ovaries. A primary~     goal is to investigate the usability of AMH as a marker besides ultrasound for discrimination~     of nonhyperandrogenic patients with PCO or multicystic ovaries.~   "
128997|NCT01878942|"~     The purpose of this study is to characterize the acute psychological, physiological,~     endocrine, and pharmacokinetic, as well as long-term psychological effects of LSD in humans.~   "
128998|NCT01878929|"~     Subcutaneous allergen immunotherapy (SCIT) is a widely used and effective treatment modality~     for allergic rhinoconjunctivitis and asthma. SCIT starts with a build-up phase during which a~     patient receives frequent, escalating doses of the allergens they are allergic to until they~     reach a predetermined maintenance dose. This is followed by a maintenance phase during which~     the allergen dose is kept constant and administered at greater intervals. Maximum clinical~     improvement is generally not seen until a patient is in the maintenance phase. Anecdotal~     evidence of possible reactions to SCIT administered during a patient's pollen season has led~     to dosage freezes during a patient's pollen season which extends the length of the build-up~     phase by many months. Prolonging the buildup phase increases the time required to obtain~     maximal benefit from SCIT, and at the same time, can decrease patient compliance with therapy~     due to the prolonged period of time when frequent injections are required.~      The aims of this study are to determine if adverse reactions to pollen SCIT are increased if~     doses are increased during pollen season.~   "
128999|NCT01878916|"~     Hyperhomocysteinemia is a risk for thrombosis. Thrombosis is more frequent in~     myeloproliferative neoplasms (MPNs) than the normal population. In this study, we~     investigated the thrombosis incidence, the effects of plasma homocysteine levels on~     thrombosis, and the correlations between folate, cobalamin, pyridoxine and homocysteine~     levels in MPNs, and to compare these results with the healthy controls.~   "
129000|NCT01878903|"~     When assessing acute post-operative pain, the validity, reproducibility and reliability of~     Visual Analogue Scale (VAS) and verbal Numerical Rating Scale (NRS) have been investigated~     extensively. The use of electronic version of VAS has been published in the recent 10 years~     yet publication related to its use in pain medicine were few. Jamison et al have shown good~     correlation between electronic VAS vs paper VAS on healthy volunteers using weight as the~     stimulus. In normal subjects as well as fibromyalgia patients, electronic form of VAS could~     be used to describe different levels of experimental heat stimulation.~      Long term study had been done where electronic pain diary were compared against paper diary~     in recording pain in 36 patients with chronic low back pain. The 2 scales showed good~     correlation. This author use a software that is Palm-top computer based. Following these few~     studies, validation study in chronic pain patient were published. A Palm-top computer based~     VAS was compared with paper NRS in 200 chronic pain patients. The pain level recorded by the~     two methods were considered equivalent by the author. However, Palm-top computer has almost~     disappeared from the market nowadays.~      Recent handheld electronic devices (iPad®) were incorporated with touch screen input~     interface which allow users to use their finger as the input device. To our knowledge, there~     is no published data concerning iPad-based VAS, especially in post-operative pain. We would~     like to compare the data obtained from electronic VAS on iPad with verbal numerical rating~     scale when acute post-operative pain is assessed.~      Hypothesis The null hypothesis is that the two pain measurement method do not correlate. The~     Spearman correlation coefficient between electronic VAS and verbal NRS will be reported.~   "
129337|NCT01874457|"~     On a previous study conducted in Brazil. The MMR vaccine from 2 different producers had a~     mumps seroconversion much lower (71%) than the expected 95%, according to the package insert.~     This could indicate that a substantial proportion of children was not protected after MMR~     dose.~   "
129001|NCT01878890|"~     Hypothesis: encouraging results of phase II study FAVE in the treatment of hormonal resistant~     prostate cancer lead us to continue clinical development of efavirenz. Furthermore, all~     available pre-clinical and clinical data lead us to conduct a Phase 1 study with efavirenz.~     Objective of this Phase I is to test doses above 600 mg / day in patients with cancer in~     order to determine the maximum tolerated dose to improve therapeutic effect.~      This study is a single center Phase I trial, conduct with dose escalation scheme of efavirenz~     by continual reassessment method likehood approach (CRML) on solid tumours (except pancreatic~     cancer) and non-Hodgkin lymphoma (NHL).~      Main objective is to determine the safety profile, and particularly the maximum tolerated~     dose of efavirenz for the treatment of patients with solid tumors (except pancreatic cancer)~     or NHL in therapeutic failure.~      Secondary objectives are:~        -  Evaluate efavirenz pharmacokinetics at 2, 4 and 12 weeks;~        -  Evaluate objective response at 12 weeks;~        -  Evaluate progression free survival at 6 months;~        -  Assess biological progression-free survival at 6 months (prostate tumours only).~      Primary Endpoint~      Safety will be evaluated according to the toxicity scale NCI-CTCAE v4.0. Dose limiting~     toxicities will be collected during the first 28 days (+ / - 7 days) after first dose of~     Efavirenz and will be defined as follows:~        -  Any drug-related toxicity with grade ≥ 3 according to NCI-CTCAE v4.0 (except alopecia,~          nausea and vomiting, regardless of grade),~        -  Any drug-related toxicity, regardless of grade, who led a treatment delay> 14 days,~        -  Score ≥ 19 HAD during treatment. Secondary Criteria~        -  Solid tumors: response and progression defined by RECIST v1.1 [Eisenhauer EA et al. EJC~          2009).~        -  Non-Hodgkin lymphomas: Response and progression defined according to Cheson criteria~          [Cheson BD et al. JCO 1999]~        -  Biological progression (particular case of prostate tumors): defined according to Scher~          [Scher HI et al. JCO 2008] Statistical Considerations This is a Phase I dose escalation~          strategy using the method CRML, described by O'Quigley and Shen [O'Quigley et al.~          Biometrics 1996] and commonly used in Phase I trials in oncology.~        -  Maximum number of eligible and evaluable subjects is 30.~        -  Six dose levels are initially defined: 600 mg, 1200 mg, 1800 mg, 2200 mg, 2600 mg, 3000~          mg.~        -  The risk of dose limiting toxicities maximum allowed is 25%.~   "
129002|NCT01878877|"~     Background Chronic pain is one of the major health problems among Western countries. It is~     also one of the most frequent reasons for seeking medical care. Chronic pain is also an~     important problem in Hong Kong. A study conducted in our institution in 2002 discovered that~     the prevalence of chronic pain among Hong Kong adult population was 10.8%. This is expected~     to be higher after a decade as the population is aging because old age is one of the risk~     factors of chronic pain.~      The changes in prevalence, pattern, severity and help seeking behavior should be explored in~     order to evaluate the attitude toward chronic pain and the efficacy of chronic pain~     treatment. A local study reported the prevalence of chronic pain in 2007 in Hong Kong was as~     high as 34.9%. The reported rate was much higher than that of Ng et al. However, the~     difference in methodology produced different results even though they were done in the same~     population, which make the comparison difficult. Besides, the treatment efficacy and help~     seeking behavior were not studied in this study. The differences in mode of data collection,~     the wording of the questionnaire and the grouping of categories also influence the results of~     the study. It is also desirable to have the update information of chronic pain in Hong Kong~     regularly (i.e. every 5 years) in view of the rapid increase in prevalence of chronic pain in~     Hong Kong.~      To compare the changes in chronic pain prevalence and related outcomes, this study design is~     similar to the previous study done in our institution in 2002. The definition of chronic pain~     is the same as the previous study, which is pain persistence for 3 months or more. The mode~     of conducting the interview and the questionnaire used will be grossly similar to the~     previous study. Because chronic neuropathic pain is common and sometimes difficult to be~     managed, questions about the incidence of chronic neuropathic pain will also be sought. This~     important information has not been reported in Hong Kong before. The purpose of this study is~     to obtain the update cross-sectional prevalence and demographic information of chronic pain~     among Hong Kong adult population. The data will be compared with a similar study 4 done 10~     years ago at our center in order to assess the change of chronic pain over the past decade.~     Treatment seeking preference will also be assessed. We hypothesize that the prevalence of~     chronic pain is increased when compare that of a decade ago.~   "
129003|NCT01878864|"~     A randomised cross-over study comparing two methods of local anaesthesia for patients~     diagnosed with periodontitis undergoing scaling and root planning. 40 patients will be~     included in the study, which aims to demonstrate that the effect of a bupivacaine lozenge is~     non-inferior to lidocaine-adrenalin injections.~   "
129004|NCT01878851|"~     Following medical history and clinical examination the children which are scheduled for~     treatment with suspected pulpary involved primary teeth will be selected. During the regular~     treatment if a pulp of primary teeth is opened and before the regular pulpotomy procedure is~     performed the blood that is flowing out of the pulp will be collected and stored until~     analyzed for the present of inflammatory markers. Clinical and radiographic evaluation will~     be obtained in follow up appointments if the child will remain in regular treatments in our~     clinic.~   "
129005|NCT01878838|"~     This study compares two FDA approved Cataract Lasers.~   "
129006|NCT01878825|"~     The purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of~     Fluviral™ containing the influenza strains recommended for the 2013-2014 season in adults~     aged 18 years and older.~   "
129007|NCT01878812|"~     The purpose of this study is to assess, in adults 18 years of age and above, the~     immunogenicity and reactogenicity of the seasonal influenza vaccine, Fluarix/Influsplit Tetra~     containing the four influenza strains (two A strains and two B strains) for the 2013/2014~     season.~   "
129008|NCT01878799|"~     Background:~      - Present treatment for hepatitis C includes the use of a weekly injection and two different~     pills. This treatment is associated with serious side effects. Drugs that can be taken by~     mouth and cure HCV infection without serious side effects would be a great help to the large~     number of people infected with HCV. GS-7977 and GS-5885 are new medications being developed~     to treat the hepatitis C virus (HCV) infection. They are still being researched and are not~     approved by the Food and Drug Administration. They are being developed as treatment for~     hepatitis C as a single pill taken once a day.~      Objectives:~      - To determine whether a combination of the two study drugs can safely and effectively treat~     HCV infection in people with HIV infection and who do not have cirrhosis of the liver.~      Eligibility:~      - Individuals who have HIV infection and have liver disease caused by infection with HCV.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood samples~          will be collected. Urine samples will be collected from participants who might become~          pregnant. If a participant has not had a liver biopsy in the past 3 years, one will be~          required.~        -  Participants will take one pill daily for 12 weeks. This pill will be a combination of~          the two study drugs.~        -  Treatment will be monitored with frequent clinic visits and blood tests over a total of~          60 weeks.~   "
129009|NCT01878786|"~     The purpose of this pilot study is to evaluate concentration-controlled everolimus with low~     dose tacrolimus compared to early conversion to CNI-free regimen and MMF/MPA with standard~     dose tacrolimus in de novo renal transplant recipients of ECD/DCD kidneys. Given tacrolimus~     and MMF/MPA is a widely prescribed immunosuppressive regimen in the United States,~     comparisons of tacrolimus and MMF/MPA regimens to investigational therapies and treatment~     regimens are needed. Also, considering the fact that ECD/DCD is a fast growing fraction of~     donors, evaluation of various regimens' effects on rather delicate ECD/DCD kidneys is~     necessary.~   "
129010|NCT01878773|"~     This study will look at how feasible it is to use a certain type of Computed Tomography (CT)~     to scan prostate cancer, called a high quality volume CT scan. It is hoped that this~     technique will help doctors provide a higher-quality image of the prostate cancer, making it~     easier to plan the area that will be treated. Using this type of CT scan will also lessen the~     amount of time patients spend in the scanner.~      This study will not offer patients a different treatment for their prostate cancer. Patients~     will receive the most appropriate standard treatment whether or not they are in this study.~   "
129012|NCT01878747|"~     The goal of this randomized trial is to examine the effectiveness of a Provider Tailored~     Intervention for Perioperative Stress (P-TIPS) in preventing high anxiety and improving the~     recovery process in children undergoing surgery. Four hospitals and all Healthcare Providers~     (HCP) in it will be randomized to either a P-TIPS Group, who will receive the newly developed~     intervention, or a Control Group who will receive a 2-hour seminar on the management of~     preoperative anxiety and postoperative pain and otherwise will provide standard care. The~     aims of this study are to:~      PRIMARY AIM~      1. Determine if P-TIPS is more effective than standard care for preventing high preoperative~     anxiety among children undergoing anesthesia and surgery. The primary outcome will be~     observational anxiety in the operating room settings as measured by m-YPAS (modified-Yale~     Preoperative Anxiety Scale).~      SECONDARY AIMS~        1. Examine the impact of P-TIPS on surgical recovery parameters such as postoperative pain,~          recovery room stay, nausea and vomiting, emergence delirium and maladaptive behavioral~          changes as measured by the PAED, and PHBQ~        2. Determine if the use of P-TIPS results in higher satisfaction and lower anxiety scores~          in the parents.as measured by the STAIs, STAIt and Parent Satisfaction questionnaires~        3. Determine if HCP in P-TIPS group display more desired behaviors and less undesired~          behaviors as compared to control group and whether these behaviors mediate the child and~          parent-level outcomes.These behaviors will be measured using the m-PCAMPIS~   "
129013|NCT01878734|"~     Addressing micronutrient deficiencies in Zambia is recognized as a national priority by the~     government due to its major contribution to morbidity and mortality among children,~     especially infants in their formative years. One of the most successful, cost-effective, and~     recommended strategy to address micronutrient malnutrition is 'in-home fortification' with~     micronutrient powders (Sprinkles being the most widely recognized) along with nutrition~     education. While this intervention has proven to be safe, effective, and efficacious in~     numerous other countries, a specific national protocol must be developed to maximize its~     effect on reducing anaemia in Zambian children. The proposed research aims to inform such~     protocol.~   "
129014|NCT01878721|"~     The purpose of this study is to evaluate the value of positron emission tomography/computed~     tomography in various inflammatory conditions caused by bacterial infection or vasculitis.~     Glucose analog FDG is sensitive to detect inflammation foci but we hypothesize that other~     imaging agents such as PK11195 and Ga-citrate may have added value in certain applications.~   "
129015|NCT01878708|"~     This is an open-label, single-arm pilot study of Oncaspar® with dexamethasone for patients~     with relapsed or refractory peripheral T-cell lymphoma (PTCL), excluding extranodal NK/T cell~     lymphoma (ENKTL). Patients will receive up to 8 courses of treatment.~   "
129016|NCT01878695|"~     NAC is the N-acetyl derivative of the naturally occurring amino acid, L-cysteine. It is a~     common over-the-counter supplement and also is available as an injectable pharmaceutical that~     protects the liver in cases of acetaminophen overdose. In the exercise physiology literature,~     both oral and injectable NAC have been shown to reduce fatigue and improve recovery from~     exertion which has interesting implications for exploring cancer-related fatigue.~      In terms of cancer cell biology, reactive oxygen species (ROS) may play an important role in~     the development and progression of breast cancer~   "
129017|NCT01878682|"~     VibraTip® is a pocket-sized, wipe-clean, disposable device that provides a consistent source~     of gentle vibration. It has been specifically designed to overcome the limitations of tuning~     forks for testing the integrity of vibration sense in clinic and by the bedside. The product~     is a hand held device that is used to examine the feet of Diabetic patients who are~     susceptible to peripheral neuropathy that can in turn lead to ulcers. Treatment is expensive~     and can be over a period of time, often not being completely resolved, and can lead to~     amputation. The product will increase awareness of foot care and achieve a reduction in~     incidence of foot ulcers.~      The study aims to evaluate the accuracy of the VibraTip device compared to the Gold Standard,~     the 10g Semmes Weinstein Monofilament (MF) Test, and the accuracy and usability of the~     VibraTip® device, as measured by different community medical practitioners.~   "
129018|NCT01878669|"~     The aim of this study is to evaluate the effects of N-acetyl cysteine on periprocedural~     myocardial infarction and major cardiac and cerebral events in patients undergoing~     percutaneous coronary intervention and who have moderate to high risk for contrast induced~     nephropathy.~   "
129019|NCT01878656|"~     Emergence agitation is a major concern in patients undergoing orthognathic surgery. The~     patients may experience the sense of suffocation during emergence due to nasotracheal~     intubation and orofacial edema. Postoperative pain is also associated with emergence~     agitation. Although there is a lot of studies about emergence agitation in children, there is~     a few in adults, furthermore, no data about comparison of emergence agitation between~     sevoflurane and desflurane anesthesia in adults. Therefore, the investigators would like to~     compare the incidence and severity of emergence agitation between sevoflurane and desflurane~     anesthesia in adults after orthognathic surgery.~   "
129020|NCT01878643|"~     The purpose of this study was :~        -  to determine the effect of inhaled antibiotics on airway bacteria in ventilated patients~        -  to determine the effect of inhaled antibiotics on respiratory infection~   "
129021|NCT01878630|"~     Superiority of additional Remote Patient Management (RPM) in patients with chronic heart~     failure (CHF) in comparison to usual care in terms of, e.g.:~        -  days lost due to unplanned cardiovascular hospitalization or death~        -  all-cause mortality~        -  cardiovascular mortality~        -  quality of life~   "
129045|NCT01878318|"~     This open-label, single arm study will evaluate the effect of RoActemra/Actemra in~     combination with methotrexate on articular damage in the hand (synovitis/osteitis and~     erosions) in patients with moderate to severe rheumatoid arthritis who have an inadequate~     response to non-biological disease-modifying ante-rheumatic drugs (DMARDs). Patients will~     receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks for 24 weeks.~   "
129079|NCT01877863|"~     The purpose of this study is to explore the impact of an intradialytic exercise program on~     functional capacity, aerobic capacity, strength, quality of life, depression,~     hospitalizations and intradialytic episodes of hypotension. The investigators would also like~     to look at the impact of exercise training over twelve weeks on hemoglobin levels as well as~     the clearance of potassium, phosphate and urea. Our hypothesis is that the above mentioned~     outcomes will positively improve over the twelve week intervention.~   "
129022|NCT01878617|"~     Historically, medulloblastoma treatment has been determined by the amount of leftover disease~     present after surgery, also known as clinical risk (standard vs. high risk). Recent studies~     have shown that medulloblastoma is made up of distinct molecular subgroups which respond~     differently to treatment. This suggests that clinical risk alone is not adequate to identify~     actual risk of recurrence. In order to address this, we will stratify medulloblastoma~     treatment in this phase II clinical trial based on both clinical risk (low, standard,~     intermediate, or high risk) and molecular subtype (WNT, SHH, or Non-WNT Non-SHH). This~     stratified clinical and molecular treatment approach will be used to evaluate the following:~        -  To find out if participants with low-risk WNT tumors can be treated with a lower dose of~          radiation to the brain and spine, and a lower dose of the chemotherapy drug~          cyclophosphamide while still achieving the same survival rate as past St. Jude studies~          with fewer side effects.~        -  To find out if adding targeted chemotherapy after standard chemotherapy will benefit~          participants with SHH positive tumors.~        -  To find out if adding new chemotherapy agents to the standard chemotherapy will improve~          the outcome for intermediate and high risk Non-WNT Non-SHH tumors.~        -  To define the cure rate for standard risk Non-WNT Non-SHH tumors treated with reduced~          dose cyclophosphamide and compare this to participants from the past St. Jude study.~      All participants on this study will have surgery to remove as much of the primary tumor as~     safely possible, radiation therapy, and chemotherapy. The amount of radiation therapy and~     type of chemotherapy received will be determined by the participant's treatment stratum.~     Treatment stratum assignment will be based on the tumor's molecular subgroup assignment and~     clinical risk.~      The participant will be assigned to one of three medulloblastoma subgroups determined by~     analysis of the tumor tissue for tumor biomarkers:~        -  WNT (Strata W): positive for WNT biomarkers~        -  SHH (Strata S): positive for SHH biomarkers~        -  Non-WNT Non-SHH, Failed, or Indeterminate (Strata N): negative for WNT and SHH~          biomarkers or results are indeterminable~      Participants will then be assigned to a clinical risk group (low, standard, intermediate, or~     high) based on assessment of:~        -  How much tumor is left after surgery~        -  If the cancer has spread to other sites outside the brain [i.e., to the spinal cord or~          within the fluid surrounding the spinal cord, called cerebrospinal fluid (CSF)]~        -  The appearance of the tumor cells under the microscope~        -  Whether or not there are chromosomal abnormalities in the tumor, and if present, what~          type (also called cytogenetics analysis)~   "
129023|NCT01878604|"~     Identify new or novel genes which may impact on cholesterol level, and establish the~     relationship between those gene mutations with atherosclerosis, as well as responses to~     lipid-lowering drugs.~   "
129024|NCT01878591|"~     To assess whether ultrasound methods can predict outcome of operative vaginal deliveries in~     nulliparous women at term with singleton pregnancies and prolonged second stage of labor.~      To compare different ultrasound assessments Compare digital assessments and ultrasound~     findings. Investigate if movement of the fetal head during active pushing is a predictive~     factor~      Null hypotheses:~        -  Ultrasound measurements cannot predict outcomes of operative vaginal delivery.~        -  Ultrasound is not better than digital examination in predicting delivery outcome.~        -  Movement of fetal head with active pushing is not a predictive factor.~   "
129025|NCT01878578|"~     The purpose of this study is determine the interaction of eslicarbazepine acetate (ESL, BIA~     2-093) on the steadystate pharmacokinetics of phenytoin in patients and to evaluate the~     tolerability and safety of ESL administered concomitantly with phenytoin in patients.~   "
129026|NCT01878565|"~     The host immunity has been generally recognized as the main factors to determine the outcome~     of chronic hepatitis B virus (HBV) infection; however, previous studies have shown that~     HBV-specific T cell and B cell function are exhausted in chronic hepatitis B (CHB) patients.~     Recently, It is suggested that hepatitis B surface antigen (HBsAg) may play a key role in the~     immune tolerance or immune exhaustion. Anti-HBV immune responses are partially recovered when~     patients achieved hepatitis B e antigen (HBeAg) seroconversion during antiviral therapy, and~     can be nearly recovered during HBsAg seroconversion. However, it is still difficult to~     achieve the ideal terminal, HBsAg seroconversion. For this reason, immunotherapy would be~     helpful to enhance the anti-HBV immunity and acquire higher HBsAg seroconversion. Here, the~     investigators propose a hypothesis that hepatitis B immune globin~     (HBIG)+granulocyte-macrophage colony-stimulating factor (GM-CSF)+HBV vaccine can enhance~     anti-HBV immune responses and improve HBsAg seroconversion in CHB patients who has achieved~     HBeAg seroconversion using nucleoside analogues treatment.~   "
129027|NCT01878552|"~     The investigator would assess if there is an incremental energy load during mechanical~     ventilation in Acute Respiratory Distress Syndrome (ARDS) patients.~   "
129028|NCT01878539|"~     An intervention program targeting patients and caregivers based on education about their~     condition and training in the use of portable coagulomenter to self monitor and training on~     the treatment adjustment to self manage, can be effective to enable patients in OACs to self~     manage as well as to identify determinant factors associated with the success and failure of~     the program.~   "
129029|NCT01878526|"~     The investigators purposes are to define the prevalence of omeprazole resistance~     gastroesophageal reflux disease (GERD) in systemic sclerosis (SSc), to compare the efficacy~     of omeprazole in combination with algycon versus omeprazole in combination with domperidone~     on the severity of reflux symptoms in omeprazole resistant GERD in SSc, and to compare the~     efficacy of omeprazole in combination with algycon versus omeprazole in combination with~     domperidone on the frequency of symptoms in omeprazole- resistant GERD in SSc.~   "
129030|NCT01878513|"~     The aim of the study is to examine whether determining treatment strategies based upon~     Cytochrome P450 2D6 (CYP2D6) genotype will improve drug response rates and clinical outcome~     in patients with psychosis.~      The investigators predict that prospectively testing CYP2D6 genotype and using this~     information to treat psychotic patients with risperidone will improve clinical outcomes.~     Specifically, CYP2D6 poor metabolizers who are treated with low dose and slow titration of~     risperidone will do better than those who are treated with usual dose and titration approach~     in terms of rates of side effects and clinical improvement.~   "
129031|NCT01878500|"~     The aim of this study is to investigate the use of intraoperative stereotactic imaging of the~     pelvic floor musculature during closure of bladder exstrophy.~   "
129032|NCT01878487|"~     To use IVUS to assess (1) culprit plaque morphology and thrombus burden in patients with~     ST-elevation myocardial infarction; (2) the efficacy of thrombus removal with an aspiration~     catheter in 40 patients during primary PCI.~   "
129033|NCT01878474|"~     The purpose of this study is to assess the safety and tolerability of single doses of TA-8995~     in healthy Caucasian and Japanese volunteers.~   "
129034|NCT01878461|"~     This study is to evaluate the efficacy and safety of M518101 in subjects with plaque~     psoriasis~   "
129035|NCT01878448|"~     Anlotibib (ALTN) is a kind of innovative medicines approved by State Food and Drug~     Administration（SFDA） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co.,~     Ltd.~      ALTN is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2 and~     VEGFR3. It has the obvious resistance to new angiogenesis. The protocol is to explore ALTN~     for the effectiveness of advanced soft tissue sarcoma and security.~   "
129036|NCT01878435|"~     The project goal is to conduct a randomized controlled trial (RCT) to test whether mobile~     phone short message system (SMS) reminders, either with or without mobile-phone based travel~     subsidies will improve timeliness, coverage, and drop-out rates of routine EPI vaccines in~     rural western Kenya.~   "
129037|NCT01878422|"~     Study Design: This is a pragmatic study on the management strategy for patients with~     metastatic colorectal cancer (CRC) who are candidates for CT, independently of any previous~     adjuvant therapy received. The aim of this study is to define the role of new target~     molecules in combination with CT in first- and second line treatment.~      First line study: Eligible patients were randomized to either treatment:~      Arm A: FOLFIRI or FOLFOX + Bevacizumab, cycle to be repeated every 2 weeks~        -  BEVACIZUMAB: Day 1,1st cycle 5 mg/kg IV infusion of 90 min Day 1, 2nd cycle if well~          tolerated, 5 mg/kg IV infusion of 60 min Day 1, 3rd cycle and subsequent cycles if well~          tolerated, 5 mg/kg IV infusion of 30 min after 5-Fluorouracile (FU) bolus~        -  FOLFIRI Day 1: Irinotecan 180 mg/m2 IV infusion 30-90 min~      Day 1,2:~      L-Folinic acid 100 mg/m2 IV infusion of 2 hours 5-Fluorouracil 400 mg/m2 as a bolus~     5-Fluorouracil 600 mg/m2 continuous IV infusion of 22 hours - FOLFOX Day 1: Oxaliplatin 85~     mg/m2 IV infusion of 2hours~      Day 1,2:~      L-Folinic acid 100 mg/m2 IV infusion of 2 hours 5-Fluorouracil 400 mg/m2 as a bolus~     5-Fluorouracil 600 mg/m2 continuous IV infusion of 22 hours Arm B: FOLFIRI or FOLFOX, cycle~     to be repeated every 2 weeks If FOLFIRI: FOLFIRI as specified in arm A without Bevacizumab If~     FOLFOX: FOLFOX as specified in arm A without Bevacizumab Duration of Therapy For both arms,~     CT was repeated until progressive disease (PD) or unacceptable toxicity occurs. If~     unacceptable CT-related toxicity occurs in ARM A, in the absence of PD patients stopped CT~     and continued with only bevacizumab 5 mg/kg as a 30-min infusion every 2 weeks until~     progression or intolerable toxicity occurred.~      Second line - it is divided in two different studies (2A and 2B):~      Study 2A: Patients from arm A and Kras Wild Type were randomized to:~        -  Arm C: FOLFIRI or FOLFOX (the CT schedule not received in 1st line trial, as defined in~          arm B)~        -  Arm D: FOLFIRI or FOLFOX (the CT schedule not received in 1st line trial, as described~          in arm B) plus CETUXIMAB CETUXIMAB 1st cycle Day 1 400 mg/m2 infusion of 120 min 2 hrs~          before CT infusion 1st cycle Day 8 and subsequent cycles 250 mg/m2 infusion of 60 min 1~          hr before CT infusion Patients from arm A and Kras Mutant were treated according to arm~          C.~      Study 2B: Patients from arm B and Kras Wild Type were randomized to:~        -  Arm E: FOLFIRI or FOLFOX (the CT schedule not received in the 1st line trial, as defined~          in arm B) plus BEVACIZUMAB~        -  Arm F: FOLFIRI or FOLFOX (the CT schedule not received in the first-line trial, as~          defined in arm B) plus BEVACIZUMAB and CETUXIMAB; cycle to be repeated every 2 weeks,~          whilst cetuximab will be administered weekly.~        -  BEVACIZUMAB 2nd day of 1st cycle 5 mg/kg IV infusion of 90 min 2nd day of 2 nd cycle if~          well tolerated, 5 mg/kg IV infusion of 60 min 2nd day of 3 rd cycle and subsequent~          cycles if well tolerated, 5 mg/kg IV infusion of 30 min after the end of 5-FU bolus on~          the 2nd day~        -  CETUXIMAB 1st cycle Day 1 400 mg/m2 infusion of 120 min 2 hr before CT infusion 1st~          cycle Day 8 and subsequent cycles 250 mg/m2 infusion of 60 min 1 hr before CT infusion~          If cetuximab will be stopped for any of the reasons specified in this protocol,~          bevacizumab will be administered as defined in arm A of the 1st line study Patients from~          arm B and Kras Mutant were treated according to arm E. Objectives of study The primary~          objective of the 1st line study is to determine whether the addition of bevacizumab to a~          poly-chemotherapy (polyCT) regimen (FOLFIRI or FOLFOX) improves efficacy in terms of~          progression-free survival (PFS). The secondary objectives of the 1st line study are to~          determine the Overall Response Rate (ORR) and the safety profile of the treatments~          administered.~      The primary objective of the 2nd line studies is to determine, separately for each study,~     whether the addition of cetuximab to a polyCT schemes (FOLFOX or FOLFIRI), or to polyCT~     schemes plus bevacizumab, improves efficacy in terms of PFS.The secondary objectives of the~     2nd line studies are to determine the ORR, the overall survival (OS) and the safety profile~     of the treatments administered.~   "
129038|NCT01878409|"~     The aim of this study is to evaluate the different aspects of sexual function among adults~     with Parkinson Disease to develop a treatment and address sexual problems as a routine part~     of diagnostic workup and therapeutic planning.~   "
129039|NCT01878396|"~     The purpose of this study, is to evaluate Circulating Melanoma Cell (CMC) changes in~     Metastatic Melanoma (MM) patients, undergoing treatment with selective inhibitors of mutated~     BRAF.~   "
129040|NCT01878383|"~     PCR detection of HSV DNA shedding in the female genital tract using the GeneXpert system~     (Cepheid, Sunnyvale CA) will be compared with traditional (routine) PCR (pregnant and~     nonpregnant women) and with HSV culture (nonpregnant women). The GeneXpert system performs~     all sample-processing steps and real-time PCR in a single integrated cartridge. The standard~     cartridge is an inexpensive disposable plastic cartridge with filtration and ultrasonic lysis~     capabilities. It consists chiefly of several combined molded plastic components: a cartridge~     body containing eleven fluid reservoirs or chambers along with an attached PCR tube, a~     specialized valve body with an ultrasonic interface containing a sub-micron filter and glass~     lysis beads, and a rotary valve with an axial syringe barrel. The operation of the cartridge~     is simple. The rotary valve contains an inlet and an outlet port. Fluid such as a sample~     buffer can be drawn up into a syringe drive through the inlet port of the rotary valve and~     then dispensed into any other chamber within the cartridge by rotating the valve and~     expelling the fluid through the outlet port. The fluid can either be passed through a filter~     contained within the valve assembly or it can be passed directly into the next chamber~     without filtration, depending on the path that is chosen. The cartridge fluidics and~     subsequent real-time PCR all are performed within the GeneXpert instrument. The GeneXpert~     contains multiple modules (ICORE units) that can be independently programmed to drive the~     syringe/rotary valve, and to perform four-color real-time PCR. Each cartridge fits inside one~     module, and all processing, PCR, and analysis steps are performed automatically. Each ICORE~     module can be run and analyzed independently, so batching of samples is unnecessary.~   "
129041|NCT01878370|"~     In a previous study, the investigators delivered graphs to family physicians that outlined~     the proportion of patients with a history of diabetes or heart disease achieving~     evidence-based quality targets derived from guideline recommendations. A qualitative~     evaluation found that participating family physicians did not act upon the feedback for two~     main reasons. First, they felt that targets recommended in guidelines often did not apply for~     particular patients. Second, they complained that had difficulty using the feedback reports~     that only provided aggregate level data for clinical action. In this cluster-randomized~     trial, the investigators test two approaches to conducting audit and feedback that aims to~     address these issues. The investigators hypothesize that feedback identifying a small number~     of patients at high-risk for cardiovascular events requiring action will more effectively~     lead to changes in clinical behavior than feedback identifying all patients not reaching~     optimal care targets.~   "
129042|NCT01878357|"~     Mass Drug Administration (MDA) and Mass Screening and Selective Treatment (MST) might be~     applied as strategies for eliminating malaria when focusing on transmission stages. Many~     studies either with MDA or MST has been done in low transmission areas demonstrated the~     impact of those activities to reduce malaria transmission. However, in high transmission such~     study is still very limited which is becoming the reason behind this study.~      A randomized cluster trial of MST study using dihydroartemisinin-piperaquine plus primaquine~     (DHP + PQ) will be conducted in some villages at the Belu regency, Nusa Tenggara TImur~     province, Central Indonesia. There will be three arms in the study, i.e. (1) intervention arm~     of mass screening and treatment with interval of 6 weeks; (2) intervention arm of mass~     screening and treatment with interval of 3 months and (3) control arm without mass screening~     and treatment. The intervention arm with 6 weeks interval represents a new proposed method to~     detection malaria infections, while the intervention arm with 3 month interval represents the~     Ministry of Health current policy of active case detection in Indonesia, and the third arm~     will serve as the control for Ministry of Health's policy.~      The study will be conducted in 6 months period and evaluate various parameters including~     malaria incidence and proportion of anemia in monthly cohort school children (in arm1, 2 and~     3), in addition to malaria prevalence in the community (only in arm 1 and arm 2). All~     positive subject in all arms will receive supervised treatment. Secondary objectives are the~     proportion of gametocytemia in the community, the proportion of malaria antibody of various~     age groups, population genetic of local parasite, submicroscopic incidence based polymerase~     chain reaction and the proportion of infective mosquitoes. Data analysis will be performed~     according to the method for cluster randomized trial evaluation.~   "
129043|NCT01878344|"~     The aim of this study is to evaluate the effects of N-acetyl cysteine on major cardiac and~     cerebral events in patients undergoing primary percutaneous coronary intervention who have~     moderate to high risk for contrast induced nephropathy.~      In a sub-group of patients coronary flow reserve will be evaluated.~   "
129044|NCT01878331|"~     Patients with an edentulous mandible restored with implants who have participated in the core~     study CR 04/07 will be recruited for this extension study. No further interventions will be~     made for this extension study other than a clinical follow-up examination and questionnaires.~     Patients will not receive an investigational treatment in this study. Patients will be~     followed at 5 to 10 years from the date of the original implant loading~   "
129338|NCT01874444|"~     The purpose of this study is to determine whether rTMS are effective in the treatment of~     tinnitus~   "
129046|NCT01878305|"~     Neuromonitoring of critically ill patients in the intensive care unit (ICU) is challenging.~     Clinical scoring systems produce insufficient information with deeply sedated patients, and~     disturbances of normal hemostasis limit the use of invasive intra-cranial pressure~     measurements. EEG based monitoring algorithms have been introduced into the operation theater~     and general anaesthesia, but these algorithms cannot be used in the intensive care setting~     without modifications. EEG is also susceptible to electrical disturbances, such as those~     created by patient movement.~      The study is conducted in Finland, in the intensive care unit of the Surgical Hospital of~     Helsinki. The total number of patients in this study is 20, and it is a part of a larger~     neuromonitoring study with a total of 110 patients. The patients are divided into four~     subgroups, as follows: 1. patients admitted to ICU with acute liver failure, 2. patients~     admitted to the postoperative cardio-thoracic ICU after cardiac surgery with perioperative~     total heart arrest, 3. patients admitted to the ICU because of status epilepticus and finally~     4. patients in critical condition, admitted to the ICU after any surgery. This study~     concentrates on the first group of patients with acute liver failure.~      Clinical care of patients is not altered. When arriving into the ICU EEG-monitoring will~     added to routine monitoring. To evaluate the neurological status the following tests are~     performed: clinical test, blood tests and transcranial doppler ultrasound. The Entropy of EEG~     is measured along with the raw EEG signal.~      The recruiting of study patients was begun in December 2005 and the final study patients were~     recruited in December 2011. GE Healthcare Finland supplies the entropy monitoring devices and~     pays the salary of the research nurses who collect the study data. Clinical investigators~     will not receive funding from any commercial company. All patients (or their next of kin)~     included have given their written informed consent for inclusion in the study.~      The aim of this study is to find new factors and new non-invasive techniques, which correlate~     with the neurological state and outcome of patients suffering critical illness.~   "
129047|NCT01878292|"~     The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone~     relative to placebo in adolescent outpatients (12-17) with major depressive disorder.~   "
129048|NCT01878279|"~     In the proposed study, the investigators will carry out novel research to evaluate both~     symptomatic and asymptomatic daily oral herpes simplex virus (HSV) shedding rates and copy~     number in children with and without HIV.~      Study Objectives:~        1. To evaluate the frequency of oral HSV reactivation in HIV-infected and uninfected~          children~           Secondary Objectives:~        2. To determine the acceptability of performing daily oral swabs in children age 3-12~   "
129049|NCT01878266|"~     This Trial offers a reduction in patient burden, which is especially preferable in children~     with a poor compliance and poor performance status. This prospective randomized trial was~     extension to the previous controlled prospective study performed in Children's Cancer~     Hospital, Egypt and registered at clinicaltrials.com (NCT01635140). The ultimate aim of this~     work is to demonstrate noninferiority of the hypofractionated regimens relative to the~     conventional regimen in a controlled randomized clinical study.~   "
129050|NCT01878240|"~     Abdominal aortic aneurysms (AAAs) continue to be a leading cause of death in older age~     groups. In the 60-85 year-old population, AAA represents the 14th-leading cause of death.~     Federal funding through Medicare has been allocated for early detection using abdominal~     ultrasound screening programs. Despite these more aggressive screening programs and concerted~     efforts by surgeons for timely repair, the incidence of ruptured AAA has continued to~     increase.~      Endovascular aneurysm repair (EVAR) has been the most common type of repair since 2006.~     Multiple studies reflecting decreased perioperative morbidity and mortality over open repair~     make this an attractive option for patients. EVAR requires more intensive follow-up than~     standard open surgical repair, however. Secondary interventions are more common to maintain~     seal of the endograft within the aorta and subsequent exclusion of the aneurysmal~     component.~      The term endoleak is specific to EVAR, and describes the primary means by which endografts~     fail. Type I endoleaks occur because of inadequate graft seal proximally or distally,~     resulting in perigraft flow and aneurysm sac pressurization. Type II endoleaks occur when~     branch arteries arising from the aneurysmal aorta back-bleed into the aneurysm sac due to~     collateral flow. Type III endoleaks occur when flow persists between segments of a modular~     graft. Type IV endoleaks occur when flow persists through endograft material (graft~     porosity). Type V endoleaks have also been called endotension, and occur when~     pressurization of the sac occurs in the absence of any demonstrable endoleak. Type I and Type~     III endoleaks are most concerning for rupture, although persistent Type II endoleaks can also~     lead to aneurysm rupture and premature death.~      The most common method of EVAR follow-up is computed tomographic angiography (CTA). These~     studies allow accurate measurement of aneurysm sac diameters and volumes. They also are~     highly sensitive and specific for endoleaks. Type II endoleaks are treated if they remain~     persistent and are present in the setting of aneurysm sac enlargement. Type I and III~     endoleaks are immediately treated when identified. Type IV endoleaks are rarely seen with~     current endograft technology.~   "
129051|NCT01878227|"~     The purpose of this study is to compare the lipid lowering effects and clinical safety of a~     natural hypolipidemic compound, coenzyme A capsule with a marketed drug, fenofibrate, in~     Chinese patients with moderate dyslipidemia.~   "
129052|NCT01878214|"~     The purpose of this study is to test an innovative and sustainable intervention to increase~     participation in a union-sponsored smoking cessation program among carpenters and floor~     layers. The investigators will conduct a randomized controlled trial comparing targeted~     messaging versus standard messaging. All subjects will receive information about the free,~     union-sponsored smoking cessation program. Subjects randomized to the intervention group will~     receive additional targeted materials to encourage enrollment in the union's smoking~     cessation program. The intervention will include monthly mailed and text messages. The~     investigators hypothesize that subjects who receive targeted messages will be more likely to~     enroll in the union-sponsored smoking cessation program, be more likely to show change in~     readiness to quit smoking, and be more likely to quit smoking compared to subjects who~     receive only standard messaging.~   "
129053|NCT01878201|"~     The purpose of this study is to Evaluate the Antihypertensive efficacy of Fimasartan 30 mg~     during 24 hours in Patients with Mild to Moderate Essential Hypertension~   "
129054|NCT01878188|"~     -  Safety and tolerability of three regimens of intravesically administered BC-819/PEI and~          BCG (number of participants with AEs, discontinuations due to AEs)~        -  Recurrence after treatment with BC-819/PEI and BCG~        -  Approximately 18 patients with superficial transitional cell carcinoma TCC) of the~          bladder~        -  After initial evaluation and qualification, patients will be randomized to one of two~          treatment groups, either alternating or sequential~   "
129055|NCT01878175|"~     Total hip arthroplasty (THA) is a common surgical procedure among Veterans. It is most often~     used to treat hip osteoarthritis, which is more common among Veterans than the general~     population. Some patients continue to experience functional limitations after THA, and~     studies have shown that these patients still tend to put greater loads on the opposite leg,~     which can increase the risk of developing osteoarthritis in that leg. One likely reason for~     these post-surgical limitations is that rehabilitation is very minimal following this~     procedure. This project will involve development and preliminary testing of a functional~     movement retraining program, designed to help Veterans improve their function and~     biomechanics after THA. The project will also develop processes for delivering this program~     in Veterans' homes, to increase accessibility.~   "
129075|NCT01877915|"~     The purpose of this study is to assess the effectiveness and safety of rivaroxaban compared~     with placebo (inactive medication), in reducing the risk of death, myocardial infarction or~     stroke in participants with heart failure and significant coronary artery disease following~     an episode of decompensated heart failure.~   "
129056|NCT01878162|"~     Law enforcement officials (LEOs) demonstrate an elevated risk for occupational injury. The~     effectiveness of exercise-based work injury prevention programs (WIPPs) to reduce the risk~     and costs associated with occupational injury has yet to be tested rigorously in LEOs. The~     accuracy of existing field tests of physical functioning to predict occupational injuries and~     related expenses remains unclear. The objectives of this study are to: (i) determine the~     effect of an exercise-based WIPP on occupational wellness and productivity in a cohort of~     LEOs, and (ii) to determine the accuracy of 2 common field assessments of physical function~     to predict lost work productivity and related expenses in a cohort of LEOs.~   "
129057|NCT01878149|"~     The purpose of this retrospective clinical evaluation is to compare VEO® single or multilevel~     results to XLIF® single or multilevel results relative to the safety endpoints. This study~     will collect retrospective data on subjects who were treated with VEO® and XLIF® at least 3~     months prior to the initiation of this study. Given that fusion generally takes at least 6~     months to determine, the aim of this study is not to determine fusion but to consider the~     short-term (out to 6 months) reported adverse events between the two cohorts.~      Devices used in both systems are cleared for use and conform to US regulatory requirements.~     The study employs these procedures and devices for uses that are consistent with their~     510(k), legally cleared, labeling.~   "
129058|NCT01878136|"~     This study will evaluate the hypothesis that the administration of intraventricular tPA~     reduces the rates of cerebral vasospasm and ventriculoperitoneal shunt-dependent~     hydrocephalus in patients with aneurysmal subarachnoid hemorrhage.~   "
129059|NCT01878123|"~     This is a Phase 1, single-dose, placebo-controlled, dose-escalation,multi-center, first time~     in human study of AMP-110 in adult subjects with rheumatoid arthritis.~   "
129060|NCT01878110|"~     This pilot study is being conducted in order to help make the case for later, more systematic~     research on the effectiveness of the Comprehensive Behavioral (COMB) model of treating~     trichotillomania (compulsive hair pulling). The goals are to standardize COMB treatment~     techniques in the form of a clear written manual for therapists; determine whether therapists~     can use these guidelines in a consistent manner in making treatment decisions; develop and~     test the reliability of measures of how well therapists are conducting the treatment; and~     collect preliminary data on the acceptability of the treatment to patients.~   "
129061|NCT01878097|"~     The purpose of this study is to evaluate the statewide application of Green Dot among high~     schools students. We hypothesize that students in high schools with Green Dot will over time~     report lower rates of sexual violence (SV) compared with students in comparable high schools~     randomized not to have Green Dot. This reduction in sexual violence will be mediated through~     a reduction in social norms supporting sexual violence (measured with violence acceptance~     scales) and an increase in bystander behaviors.~   "
129062|NCT01878084|"~     The purpose of the present research is to evaluate the effect of bioactive glass in bone~     regeneration immediately following extraction of mandibular and maxillary premolars.The~     hypothesis of the study assumes that this treatment would promote the healing of the~     extraction socket while preserving both the height and width of the bone. Furthermore, it~     would allow more effective tooth movement during orthodontic treatment.~   "
129063|NCT01878071|"~     In recent years, greater emphasis has been placed on the link between oral and systemic~     health. Obesity, a growing medical problem worldwide, has been associated with multiple~     chronic inflammatory diseases such as diabetes mellitus and cardiovascular disease. With~     respect to the effect of obesity on periodontal health, it has been shown that obese subjects~     exhibit higher inflammation around natural teeth and are at increased risk of tooth loss than~     individuals with normal weight. Peri-implantitis, an inflammatory condition of bacterial~     origin that occurs around oral implants and resembles periodontal disease, has become a~     serious concern for the dental profession given its increasing prevalence and challenging~     treatment. There is also strong evidence that individuals with a history of periodontitis are~     also at risk for peri-implantitis. However, knowledge about the pathogenesis and treatment of~     peri-implantitis is scarce. Hence, it is extremely important to understand the implications~     of excessive body fat on peri-implant health. Based on the current understanding on the~     effect of obesity on systemic and local inflammation around natural teeth, the investigators~     hypothesize that obesity will have a significant impact on peri-implant health by inducing an~     increased inflammatory response as measured by clinical as well as molecular markers of~     inflammation.~   "
129064|NCT01878058|"~     This study will look at the feasibility of using a type of Magnetic Resonance Imaging called~     Susceptibility Weighted Imaging (SWI) to detect your implanted radioactive seeds. Researchers~     hope that using SWI will eliminate the need to use CT imaging to detect your implanted~     radioactive seeds.~      This study will also see if the MRI seed detection is as effective as current standard~     practice of seed detection (routine MRI and CT imaging). This technique would be beneficial~     for brachytherapy without the need to fuse the MRI and CT images, as is done currently.~   "
129065|NCT01878045|"~     Background:~      - An ongoing study is looking at American Indians who have kidney problems caused by type 2~     diabetes. Kidney disease due to type 2 diabetes is a major problem in American Indians. We~     previously found that early treatment of kidney disease with losartan was probably beneficial~     for reducing progression of the disease. Researchers now want to see if these benefits~     continue to be seen several years after the end of the treatment study.~      Objectives:~      - To study long-term benefit of losartan treatment for diabetic kidney disease in American~     Indians with type 2 diabetes.~      Eligibility:~      - Participants in the American Indian diabetic kidney disease study (OH95-DK-N037).~      Design:~        -  Participants will have a physical exam and medical history before starting the study.~          Blood and urine samples will be collected.~        -  Participants will have a set of tests as part of this study. Those who have severe~          kidney problems, such as kidney failure, will only have a basic kidney exam with scans.~          The remaining participants will have a full urine collection and analysis. They will~          also provide a kidney biopsy.~        -  Treatment will not be provided as part of this study.~   "
129076|NCT01877902|"~     STUDY OF USE OF PEMETREXED IN PATIENTS WITH NON-SMALL LUNG CANCER METASTATIC IN ANDALUSIAN~     PUBLIC HEALTH SYSTEM~   "
129077|NCT01877889|"~     The purpose of this study is to compare the pharmacodynamics (ie, how the drug affects the~     body) of canagliflozin with the pharmacodynamics of dapagliflozin.~   "
129066|NCT01878032|"~     Background:~      - The purpose of this study is to find out whether color vision measured with the Cambridge~     Color Test is a good way to examine the severity of inherited retinal diseases (IRDs). IRDs~     are a major cause of vision loss worldwide, but very little is known about how the diseases~     affect color vision over time. This study will tell us if color vision may be used to track~     changes in inherited retinal diseases over time.~      Objectives:~      - To improve understanding of color vision as a way to measure changes in inherited retinal~     diseases.~      Eligibility:~        -  People 5 years of age or older who have an IRD.~        -  Healthy volunteers at least 5 years of age.~      Design:~        -  Participants will make at least one visit to the National Eye Institute clinic. If they~          sign up for more tests, they may have up to three visits to the NEI clinic.~        -  Participants will be asked questions about their medical and eye history.~        -  Participants will be given an eye exam, including eye drops to dilate their pupils. They~          will take the Cambridge Color Test, which includes looking at a monitor and pressing a~          button, and arranging colored circles. Several other tests may be offered, but~          participants can decline to take them.~        -  Treatment will not be provided as part of this study.~   "
129067|NCT01878019|"~     Background:~      - Researchers want to look at how the brain responds to painful stimulations. They also want~     to see if these responses are different in people with and without chronic pain. To test the~     brain s response, they will use a chemical called naloxone. Naloxone is used to treat~     overdoses of painkilling drugs like morphine. It may be able to block the effect of a~     pain-relieving cream. Researchers will apply a pain-relieving cream to a person s lower leg~     and look at the results of sensitivity tests with either naloxone or a placebo. This study~     will compare the results from people with chronic pain (like fibromyalgia) to those of people~     without chronic pain.~      Objectives:~      - To look at the brain s response to pain in people with and without chronic pain.~      Eligibility:~        -  Individuals at least 18 years of age who have fibromyalgia.~        -  Healthy volunteers at least 18 years of age.~      Design:~        -  This study will involve a screening visit and two testing visits. The testing visits~          will be about a week apart.~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. After the screening participants will be administered several~          questionnaires about their personality, and their thoughts and feelings.~        -  At the first visit, participants will try out the magnetic resonance imaging (MRI) scan~          before using it at the next visit. They will then have the painkilling cream applied on~          one part of their lower leg and a normal moisturizing cream on the other part of their~          lower leg. They will have heat pulses on these skin areas and rate the pain.~        -  At the second visit, participants will have tests in the MRI scanner. The heat pulse~          tests will be repeated after an infusion of either naloxone or a placebo.~   "
129068|NCT01878006|"~     Background:~      - Small differences in genes may alter responses to drugs. One gene that has different forms~     is the mu opioid receptor gene. People with one form of this gene are more sensitive to~     alcohol. People with a different form are sometimes more sensitive to pain. Morphine and~     other prescription pain pills produce pain relief by acting at the mu opioid receptor.~     Researchers want to see how well a drug called remifentanil can help determine sensitivity to~     pain. Remifentanil is a strong but short-acting pain medication that is sometimes used for~     anesthesia during surgery. The study will test how much the drug causes the pupils to~     constrict.~      Objectives:~      - To see if remifentanil can help determine pain sensitivity.~      Eligibility:~      - Individuals between 21 and 55 years of age who are taking pain pills that were prescribed~     to treat pain from a medical or dental procedure.~      Design:~        -  This study has a screening phase and a study phase. The screening phase involves one or~          two visits of 5 to 6 hours. The study phase is one outpatient visit that will take about~          3 hours.~        -  Participants will be screened with a medical and psychiatric history and physical exam.~          They will be asked about drinking and drug-taking history, and any family history of~          alcoholism or drug abuse. Blood, urine, and breath samples will be collected.~        -  During the study session, participants will test their sensitivity by placing one hand~          in cold water. Pupil diameter will be measured before and after the sensitivity test.~        -  After a blood sample is taken, participants will receive the remifentanil. The~          sensitivity test will be repeated. Final blood samples will be collected. A brief~          physical exam will also be performed.~        -  Participants will stay in the clinic until the effects of the drug have worn off.~        -  About 1 week after the study session, participants will have a follow-up phone call.~   "
129069|NCT01877993|"~     Autonomic nerve function is involved in both blood pressure (BP) regulation and the~     pathogenesis of coronary artery spasm (CAS), but few studies have been published about the~     relationship between CAS and BP, with the exception of studies that explore hypertension as a~     risk factor for CAS. The purpose of this study was to investigate the incidence of CAS and~     atrioventricular (AV) block in association with BP level. The investigators will register~     consecutive patients who underwent coronary angiography with an acetylcholine (Ach)-induced~     provocation test from November 2004 to May 2012. The investigators exclude from the patients~     who were taking antihypertensive drugs or who had a documented history of cardiovascular~     disease in order to avoid the confounding effects of cardiovascular medications on coronary~     vasomotion. CAS is defined as >70% luminal narrowing on Ach provocation and /or concurrent~     chest pain. The study population will be divided into quartiles of rising systolic BP and~     diastolic BP. The incidence of Ach-induced CAS according to each systolic BP/diastolic BP~     quartile will be evaluated.~   "
129070|NCT01877980|"~     The aim of the present study was to evaluate the ultrasonographic airway measurement in~     pediatric patients to compare the correct size of an uncuffed endotracheal tube (ETT) with~     the minimal transverse airway diameter (MTAD) with tube size predicted by different~     age-related formulas and diameter of little finger.~      Previous studies already showed that a prediction of pediatric ETT is possible with the~     ultrasonographic measurement of the MTAD. In this study measurements are performed at three~     predefined anatomic structures of the airway with each of These at two airway pressures.~      The investigators hypothesize that one of the specific measurements predicts the fitting ETT~     size better than age-related formulas or diameter of little finger.~   "
129071|NCT01877967|"~     This research aims to determine whether a 12 week daily dose of VSL#3 has any measurable~     effects on memory, attention, executive function or self-reported mood and anxiety in healthy~     older adults.~   "
129072|NCT01877954|"~     The primary aim of this study was to compare the absolute and relative effectiveness of~     asthma management in paediatric patients in the UK on inhaled corticosteroid (ICS)~     maintenance therapy as extra-fine HFA-BDP (Qvar®) pressurised metered dose inhaler (pMDI)~     compared with fluticasone propionate (FP) pMDI.~   "
129073|NCT01877941|"~     The specific aim of this study is to assess whether a device approved by the FDA to measure~     pulse oximetry can accurately estimate cardiac output.~   "
129074|NCT01877928|"~     The purpose of this study is to assess the efficacy of the Boussignac positive airway~     pressure system (a mask) applied immediately following post-operative extubation in improving~     lung function in patients with obstructive sleep apnea (OSA). Assessments will be done before~     surgery and then at 1, 2 and 24 hours following extubation and will be compared to standard~     care for perioperative airway support. The study aims to give a broader and more inclusive~     picture (than the current literature) in terms of whether the Boussignac CPAP system should~     be considered for utilization by anesthesiologists caring for surgical patients with OSA.~   "
129078|NCT01877876|"~     Evaluation of a new generation of sensors for monitoring blood hemoglobin. The newest version~     is RevK.~   "
129081|NCT01877837|"~     This protocol will be investigating the use of stem cell transplantation, in related donors,~     to cure sickle cell disease. Sickle cell disease is a recessive disorder caused by a point~     mutation that results in the substitution of valine for glutamic acid at the sixth position~     in the B-chain of hemoglobin. This leads to sickling of the red blood cells under many~     conditions, such as hypoxia, dehydration, and hyperthermia. The sickling leads to~     vaso-occlusion, which causes irreversible damage in almost all systems in the body, including~     the central nervous system (CNS), lungs, heart, bones, eyes, liver, and kidneys.~   "
129082|NCT01877824|"~     All Danish trainees in surgery in a two-year period asked for participation when enrolled in~     the formal five-year training program for specialty in surgery. The participants are~     randomized for either educational intervention or control (without intervention). The~     intervention group receive a skills-lab course in hernia repair followed by an opportunity to~     perform 20 groin hernia repairs in their departments within 4-8 weeks. Their performance will~     be video recorded three times during the intervention and as follow-up at end of the first~     year of training. After termination of the hernia training program a similar program for~     laparoscopic cholecystectomies are made. Each participant receive both intervention. The~     control group are video recorded at start of their first year and at end. All videos are~     blindly assessed with a validated rating scale of operative performance. The purpose is to~     assess if a fast-track program improves technical skills and if a change is sustained.~     Furthermore we want to compare outcome in similar training programs in open and laparoscopic~     skills.~   "
129083|NCT01877811|"~     This is a first-in-human, multicenter, open-label study consisting of 2 phases. Phase 1 is a~     dose escalation study of RXDX-105 (formerly known as CEP-32496) in patients with advanced~     solid tumors aimed at defining the recommended Phase 2 dose (RP2D) and schedule for~     administration. Phase 1b is a dose expansion in approximately 90 patients with advanced solid~     tumors with specific histologies and/or molecular alterations of interest. Patients in Phase~     1b will be treated at the RP2D determined in Phase 1.~   "
129084|NCT01877798|"~     Reducing tissue hypoxia is the ultimate goal of severe sepsis and septic shock~     therapy.Venoarterial PCO2 difference /arteriovenous O2 content difference ratio~     (△PCO2/Ca-vO2) is considered to be a good indicator of global anaerobic metabolism.The~     purpose of this study was to compare the efficacy of △PCO2/Ca-vO2 and central venous oxygen~     saturation (ScvO2) in the treatment of severe sepsis and septic shock.~   "
129085|NCT01877785|"~     This randomized, double-blind, placebo-controlled, single-ascending dose study will assess~     the safety, tolerability and pharmacokinetics of ascending doses of MHAA4549A in healthy~     volunteers. Volunteers will be randomized to receive a single dose of MHAA4549A or matching~     placebo.~   "
129086|NCT01877772|"~     This Clinical Trial is being conducted to study an adjunctive treatment for rotator cuff~     repair; bone trephination. Trephination is a procedure that involves making small~     perforations in the bone that the tendon is repaired to. The rotator cuff is repaired by~     sewing the tendon down to the bone in the shoulder. Trephination is a new technique that is~     used in addition to the standard method of repairing the rotator cuff tendon. The control~     group will undergo the standard repair for rotator cuff tears.~      It is the investigators' hypothesis that healing rates in patients who undergo bone~     trephination will be higher compared with surgery without trephination in arthroscopic~     rotator cuff repair at 24 months post-operatively.~   "
129087|NCT01877759|"~     Cirrhosis is caused by sustained liver damage over several years either by alcohol, viral~     infection (Hepatitis B, C), a toxic substance (for eg. drugs, excess copper or iron in the~     liver), or by blockage of biliary system such that the liver undergoes progressive scarring~     that slowly replaces all of normal liver cells.(LC) represents a late stage of progressive~     hepatic fibrosis characterized by distortion of the hepatic architecture and formation of~     regenerative nodules. For this condition of disease the liver transplantation is one of the~     only effective therapies available ,but due to lack of donors, surgical complications,~     rejection, and high cost are it`s serious problems.~      Presently stem cells are used to be a one of the treatment for the same. So our approach is~     to evaluate the safety and efficacy of mesenchymal stem cell in condition of liver cirrhosis~     .~   "
129088|NCT01877746|"~     The aim of this study is to compare the effect of combined immunosuppressive therapy given on~     the top standard medical therapy of chronic heart failure according to current guidelines~     with standard medical therapy of chronic heart failure alone in patients with infammatory~     cardiomyopathy (ICM).~      Suitable subjects are characterized by EMB established presence of myocardial inflammation /~     negative polymerase chain reaction assay (PCR) findings of cardiotropic infectious agents and~     with varying duration of heart failure symptoms and left ventricular (LV) systolic~     dysfunction (phase A).~      Further, to compare the effect of two regimens of combined immunosuppressive therapy in these~     patients with ICM (phase B).~   "
129089|NCT01877733|"~     The purpose of this study is to investigate the effect of maximal strength training (MST)~     compared to standard rehabilitation in patients operated with total knee arthroplasty.~     Previous studies report reduced physical function and muscle strength despite successful~     surgery inserting an artificial implant.~      Furthermore, great loss of muscle strength has been found in these patients in the early~     postoperative phase.~      The study is a randomized controlled trial. The investigators hypothesize that MST will~     increase muscle strength and physical function more than standard rehabilitation.~   "
129090|NCT01877720|"~     Neurally adjusted ventilatory assist (NAVA) has been shown to improve patient- ventilator~     interaction and reduce asynchronies. This is a short-term physiologic comparison between PSV~     (pressure support ventilation) and NAVA in delivering noninvasive ventilation through a nasal~     cannula, in premature infants postextubation. Patients will undergo a 30-min crossover trial~     of noninvasive PSV and NAVA, 15 minutes each. Diaphragm electrical activity (EAdi)and airway~     pressure (Paw) are recorded to derive neural and mechanical respiratory rate and timing,~     inspiratory trigger delays time of synchrony between diaphragm contraction and ventilator~     assistance, and the asynchrony index (AI).~   "
129091|NCT01877707|"~     To identify whether home monitoring of multiple physiological parameters and biomarkers in~     sputum could provide advanced warning of an infective exacerbation or treatment failure~     before changes in patient-reported symptoms.~   "
134873|NCT01801930|"~     To assess the safety and tolerability of OCV-C02 in Patients With Advanced or Relapsed~     Colorectal Cancer Who Are Refractory or Intolerant to Standard Chemotherapy~   "
129092|NCT01877694|"~     The purpose of this study is to evaluate the microbiological and clinical efficacy of~     Auriclosene compared to its vehicle for bacterial conjunctivitis. Adults and children one~     year of age and older with bacterial conjunctivitis in at least one eye may be eligible.~     Subjects will be randomly assigned to receive either Auriclosene Ophthalmic Solution or~     Vehicle Ophthalmic Solution.~   "
129093|NCT01877681|"~     Introduction: Pressure ulcers (PU) are the most common chronic wounds in all levels of care~     in health centers. The chronic wound care by skilled personnel is key to healing and~     management of these injuries. An inter-clinical telematic program for PU in Primary Care (PC)~     can improve the effectiveness of interventions and cost savings.~      Objective: To evaluate the effectiveness and costs reduction after the implementation in PC~     setting of a chronic wounds reference nurse and a teleconsultation program aimed to nurses~     for the management of PU in patients in home care setting.~      Methodology: A prospective pilot clinical trial in which 46 primary care nurses in Osakidetza~     will be randomly assigned to two parallel groups: experimental group and control group. Each~     nurse will recruit at least 1 new patient in home care with PU in stage II-III. The~     intervention will consist of a telematic advice from the reference nurse regarding chronic~     wound management in relation to a specific PU. Patients will be monitored for 8 weeks with a~     minimum of 4 repeated measurements of the Resvech Index 2.0. To evaluate the effectiveness of~     the intervention, multilevel models or linear mixed models to take into account the~     auto-correlation at the individual level and nurse, will be used~   "
129094|NCT01877668|"~     This is a 12-month study investigating the effectiveness and safety of tofactinib in treating~     the signs and symptoms of active psoriatic arthritis and improving physical function and~     preserving bone structure in patients with an inadequate response to a traditional,~     nonbiologic disease-modifying antirheumatic drug. Adalimumab is used as a comparator.~   "
129095|NCT01877655|"~     The purpose of the study is to evaluate the efficacy of ASP0113 compared with placebo as~     measured by a primary composite endpoint of overall mortality and CMV end organ disease (EOD)~     through 1 year post-transplant. Safety of ASP0113 in subjects undergoing allogeneic HCT will~     also be evaluated.~   "
129096|NCT01877642|"~     This study will compare the safety and effects over time for giving both ADASUVE and~     lorazepam (intramuscular) compared to that of each agent given alone.~   "
129097|NCT01877629|"~     To explore the pharmacokinetics (PK) of a single dose of two different formulations of~     ACT-129968, i.e., tablet versus capsule and to evaluate the safety and tolerability of a~     single dose of two different formulations of ACT-129968, i.e., tablet versus capsule.~   "
129098|NCT01877616|"~     Little is known on the prevalence of sleep disorders and their role in the increased~     prevalence of cardiovascular diseases in the developing world. We To assess the prevalence of~     major sleep disorders in a rural South American population, and to determine whether these~     conditions are associated with a poor cardiovascular health or with the occurrence of stroke~     or ischemic heart disease. This is a three-phase, population-based, door-to-door survey in~     Atahualpa. During phase I, all residents aged ≥40 years will be screened with validated~     Spanish versions of five questionnaires to evaluate major sleep disorders. In phase II,~     neurologists will examine persons suspected of having a sleep disorder and a random sample of~     negative individuals to assess the prevalence of these conditions and to validate the~     accuracy of questionnaires. In phase III, patients with a confirmed sleep disorder will~     undergo nocturnal polysomnography for achieving a more specific diagnosis. The occurrence of~     sleep disorders will be correlated with the cardiovascular health of the population as well~     as with the presence of stroke and ischemic heart disease. This epidemiological study may~     prove cost-effective in improving sleep conditions of people living in rural areas of~     developing countries, and may be used as a model for the evaluation of sleep disorders and~     their cardiovascular correlates in these populations.~   "
129099|NCT01877603|"~     Irisin is a signaling protein that is released into the blood from skeletal muscle after~     proteolysis of the membrane protein FNDC5 . FNDC5, encoded by the Fndc5 gene. Irisin activity~     on subcutaneous white adipose tissue, both in culture and in vivo, stimulated UCP1 expression~     and induction of brown adipocytes in white adipose tissue depots, a process known as white~     fat ''browning''. Irisin increases total energy expenditure in animal models, and irisin~     expression in mice fed a high fat diet resulted in a significant improvement in glucose~     tolerance and a reduction in fasting insulin levels. Collectively, these data suggest that~     decreased serum irisin levels may be associated with the development of insulin resistance~     and Type 2 diabetes. Indeed, some studies showed that irisin levels were decreased in newly~     diagnosed Type 2 diabetes.~      Endothelial dysfunction is an early physiological event in atherosclerosis. However, to date,~     no data are available on the relationship between circulating irisin and endothelial~     dysfunction in diabetes. Therefore, the investigators hypothesized that circulating irisin~     level is associated with endothelial dysfunction.~   "
129100|NCT01877590|"~     Cardiovascular complications account for the highest mortality in type 2 diabetic patients,~     mainly due to coronary artery disease (CAD). Most of the attention in treating CAD in type 2~     diabetes is understandably directed toward treating coronary artery conditions. However there~     are other treatable culprits in these patients.~      Left ventricular hypertrophy (LVH) is widespread in type 2 diabetic patients with CAD, even~     in the absence of hypertension. It is a strong predictor of cardiovascular events and~     all-cause mortality. Regression of LVH has been associated with an improved prognosis,~     independent of change in blood pressure (BP). Therefore, cardiovascular events and mortality~     in type 2 diabetes with CAD might will be reduced if the investigators can find novel~     therapies to regress LVH.~      Alpha-lipoic acid reduces oxidative stress which then regresses LVH. Alpha-lipoic acid can~     improve endothelial function in diabetic conditions. Hence, the main aim of this study was to~     assess whether alpha-lipoic acid could regress LVM in type 2 diabetic patients with CAD.~   "
129101|NCT01877577|"~     This study aims to evaluate the effect of vitamin D3 supplementation on disease activity and~     quality of life in IBD patients deficient in vitamin D, and also help determine the optimal~     dose of vitamin D3 for them.~      Hypothesis: Supplementation of vitamin D3 in IBD patients with hypovitaminosis D can improve~     their quality of life and decrease IBD activity.~   "
129102|NCT01877564|"~     The purpose of this research is to determine the effects of Metformin, a well tolerated drug~     widely prescribed for treatment of Type 2 Diabetes Mellitus, on endometrium cancer patients.~   "
129103|NCT01877551|"~     Rates of cardiovascular disease and diabetes are more than 2-fold greater in HIV infected~     people than the general population. Protease inhibitor booster antiretroviral therapy~     (PI-ART) which is used by ~50% of HIV infected people in the USA is an established risk~     factor for diabetes. Tauroursodeoxycholic acid (TUDCA), a naturally occurring bile salt,~     improves insulin sensitivity in HIV uninfected subjects, although the mechanisms for these~     benefits are unclear. This study will explore the hypothesis that TUDCA will improve insulin~     action in people with HIV who are receiving PI-ART. Further, this project will clarify the~     molecular mechanisms responsible for these improvements potentially benefiting society,~     irrespective of HIV status.~   "
129104|NCT01877538|"~     AIM: To validate the tracer [11C]donepezil for use in the parasympathetic nervous system.~      MATERIALS AND METHODS: The Investigators will include 7 healthy males aged 45-75 in our~     study. The participants will receive a careful medical examination, including a neurological~     examination, as part of the inclusion process. The subjects also have an MRI scan of the~     brain. PET/CT scans with [11C]donepezil are conducted. Six subjects will receive two PET/CT~     scans - once for the upper abdominal region and once for the head region two evaluate dynamic~     binding characteristics of the tracer in internal organ. Additionally, one single subject~     will receive 5 consecutive whole body PET scans to estimate radioactive dosimetry of this~     tracer.~      PERSPECTIVES: The study will potentially result in the development of a PET ligand for~     imaging the parasympathetic nervous system. This will have applications for research in~     Parkinson's disease, diabetes, heart disease and other disorders, in which the autonomic~     nervous system is involved~   "
129105|NCT01877525|"~     Resect and discard (RD) is a new paradigm for management of diminutive colorectal polyps~     wherein histology is determined by real-time endoscopic imaging; polyps are then resected and~     discarded rather than sent for histopathological review. The aims of this study were to~     compare the surveillance recommendations between RD and the standard of care where polyps are~     sent for histopathological review in a mixed setting of academic and community~     gastroenterologists and to evaluate the diagnostic performance of an RD program for~     management of diminutive polyps.~   "
129106|NCT01877512|"~     Rationale: Abnormally low and high levels of insulin-like growth factor-I (IGF-I) are both~     associated with increased metabolic risk. Since (U-shaped) associations of IGF-I, within the~     normal range, have also been found with cardiovascular risk factors and disease in the~     general population, it would be interesting to investigate if this association can also be~     found in growth hormone deficient (GHD) adults treated with Growth Hormone (GH). This could~     be of interest for endocrinologists prescribing GH in clinical practice because strict dosing~     may become even more important. Next to that, scientific evidence for clinical practice is~     wanted.~      Objective: Next to cardiovascular risk factors (main objectives: body composition and lipid~     profile; secondary objectives: remainder) we investigate the effect on glucose metabolism,~     physical performance, and neuropsychological functioning of different levels of IGF-I in GH~     treated GHD men and women.~      Study design: Open-label randomized trial.~      Study population: At least 32 subjects, both childhood as adult onset GHD men and women,~     receiving GH treatment for at least one year, with an age between 20 and 65 years.~      Intervention: At entry subjects are already receiving GH treatment according to general~     clinical practice, and are expected to demonstrate an IGF-I concentration of 0 - 1 SD score~     (SDS) (normal dose). The group of men and group of women will be randomized to receive either~     a decrease of their regular dose of GH treatment (IGF-I target level of -2 - -1 SDS) (low~     dose), or an increase of their regular dose, (IGF-I target level of 1 - 2 SDS) (high dose)~     for at least 24 weeks.~   "
129107|NCT01877499|"~     Two recent randomized controlled trials (RCT) on online hemodiafiltration (HDF) did not show~     a treatment effect on patient survival when compared with low‐ or high‐flux hemodialysis.~     Interestingly, post‐hoc (on treatment) analyses from both trials unequivocally showed reduced~     mortality in the patient group achieving the highest convection volumes. Moreover, a third~     trial recently found a significant 30% decrease in mortality when HDF was applied with a mean~     convection volume of 23.7 L per session, which was somewhat higher than the average volumes~     reached in the aforementioned trials. Altogether, these findings support the concept of a~     dose-response effect, in which a minimally delivered convection volume is required in order~     to show a survival benefit.~      Hence, the question arises whether high convection volumes are achievable in the majority of~     patients. The aim of this study is thus to test the following hypothesis: high‐volume (>22~     liters per treatment) post-dilution on‐line hemodiafiltration (HDF) is achievable in the~     majority (>75%) of patients treated with chronic intermittent hemodialysis. This will be done~     through the use of a dedicated standardized protocol, in which the three most important~     determinants of convection volume will be successively optimized: treatment time, blood flow~     rate and filtration fraction.~   "
129108|NCT01877486|"~     To determine the efficacy of cryoablation alone in patients with paroxysmal atrial~     fibrillation who have been pretreated with dofetilide and converted from persistent atrial~     fibrillation.~   "
129109|NCT01877473|"~     The hypothesis of this study is that by facilitating reverse atrial remodeling with~     maintenance of sinus rhythm in the weeks preceding ablation makes it feasible to perform a~     simple pulmonary vein isolation (PVI) with results equivalent or superior to more complex~     atrial ablation for patients with persistent AF.~   "
129110|NCT01877460|"~     This study compares the effects of isovolumetric (325 ml) preloads of chocolate milk~     supplemented with sodium alginates at incremental doses on inter-meal glucose levels,~     appetite scores and food intake in healthy adult men. The findings of this study will~     illustrate whether the addition of sodium alginate to chocolate milk will improve the~     glycemic properties of chocolate milk and will potentiate its satiating characteristics. This~     study will also elucidate whether sodium alginates, incorporated into chocolate milk, will~     influence glycemia, appetite sensations and food intake in a dose-dependent manner. It is~     hypothesized that there will be a synergy between milk and sodium alginate beyond either~     alone. When combined with milk components, sodium alginate is expected to improve glycemia~     and induce satiety more than does either milk alone or alginate alone.~   "
129339|NCT01874431|"~     To assess a new drug, BAY94-8862 given orally at different doses, to evaluate whether it is~     safe and can help the well being of patients with type 2 diabetes and diabetic nephropathy.~     These treatment doses will be compared to placebo.~   "
129111|NCT01877447|"~     Transcranial direct cranial stimulation (tDCS) is a novel technique based on the application~     of a weak electrical current over the scalp through two electrodes - the anode, which~     facilitates neuronal depolarization, and the cathode, which leads to neuronal~     hyper-polarization. Recently, several open-label and sham-controlled clinical trials applied~     daily tDCS sessions for the treatment of major depressive disorder (MDD). Theoretically, tDCS~     displays depression improvement through anodal stimulation over the left dorsolateral~     prefrontal, inducing excitability-enhancing effects over this area, which is hypoactive~     during the acute depressive episode. The present study is aimed at comparing two different~     tDCS protocols: (1) active anodic stimulation over left dorsolateral prefrontal cortex with~     cathode placed over an extra cephalic area; (2) active cathode placed over the right~     dorsolateral prefrontal cortex with anode placed over an extra cephalic area.~   "
129112|NCT01877434|"~     Reverse total shoulder arthroplasty (RSA) is a accepted treatment for different shoulder~     diseases with improved functional outcome. This study has evaluated patients operated with~     reversed shoulder arthroplasty after 1,5-3 years postoperatively with patient reported~     outcome, clinical and radiological examination, complication and reoperations. The radiologic~     phenomenom and clinical impact of scapular notching (SN) and arm length difference has been~     evaluated.~   "
129113|NCT01877421|"~     This study is to assess the safety and tolerability of single doses and multiple doses in~     reducing plaque and gingivitis when delivered in a chewing gum formulation.~   "
129114|NCT01877408|"~     To identify a minimally-invasive surgical circumcision technique for men, which is easy to~     learn and perform, is safe, and is associated with high patient satisfaction and excellent~     cosmetic results.~   "
129115|NCT01877395|"~     The aim of the study is to document the safety and immunogenicity of Purified Vero Rabies~     Vaccine (VRVg) when given in a simulated post-exposure regimen, i.e. with co-administration~     of human rabies immunoglobulins (Imovax® Rabies).~      Primary Objectives:~        -  To demonstrate that VRVg is non-inferior to Imovax® Rabies in terms of proportion of~          subjects achieving a rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 international~          units (IU)/mL at Day 14.~        -  To demonstrate that the observed proportion of subjects achieving an RVNA titer ≥ 0.5~          IU/mL at Day 14 is at least 99%, with a lower limit of the 95% confidence interval (CI)~          of at least 97%.~      Secondary Objectives:~        -  To assess the clinical safety of each vaccine after each vaccine injection when~          administered in a simulated post-exposure schedule.~        -  To describe the geometric mean titer ratio (GMTR) between the 2 vaccine groups at Day~          14.~   "
129116|NCT01877382|"~     This will be a Phase 1, open-label study of DS-3032b to assess its safety and tolerability,~     identify a maximum tolerated dose (MTD)/tentative recommended phase 2 dose (RP2D), and assess~     its pharmacokinetic (PK)/ pharmacodynamic (PD) properties in subjects with advanced solid~     tumors or lymphomas.~      Approximately 5 US sites are planned for Part 1 (Dose Escalation). Approximately 10 US sites~     are planned for Part 2 (Dose Expansion).~   "
129117|NCT01877356|"~     The purpose of this study is to compare unilateral spinal anesthesia using hyperbaric~     Prilocaine with classical bilateral spinal anesthesia using plain Prilocaine according to~     block characteristics and quality of micturition, standardized to the subjects own functional~     bladder capacity. Our hypothesis is that unilateral spinal anesthesia will provide faster~     time to micturtition and discharge, lesser hypotension and lesser micturition problems.~   "
129118|NCT01877343|"~     This is a single-center, non-randomized study.Enrolled patients will be placed on a tilt~     table and a stress test will be performed in a total of 4 different positions. Their blood~     pressure will be measured at each position. Also, a pulse oximeter will be placed on the~     forehead to measure pulse rate and strength. These results will be compared to cardiac~     functional classifications defined by New York Heart Association (NYHA) criteria for adults~     and New York Pediatric Heart Failure (NYPHF) index for our pediatric age patients. The~     primary aim of this initiative is to assess the discriminatory value of a cardiac functional~     health classification based upon the degree of dependency of cardiac function on changes in~     cardiac preload and afterload circulatory volume.~   "
129119|NCT01877330|"~     This is a prospective randomized clinical trial to determine where is the optimal location~     for local anesthetic injection for ultrasound guided interscalene nerve blocks. The~     investigators are investigating if local anesthetic deposited between the nerve roots is more~     effective than local anesthetic deposited in the interscalene groove.~   "
129120|NCT01877317|"~     The purpose of this clinical study is to validate the comparability of prescription formula~     fitting of hearing aids based on full diagnostic audiometry and SelfFit interactive fitting~     of hearing aids based on hearing loss screening (mild to moderate hearing losses) using~     in-situ audiometry, provided and executed through the mobile medical app.~   "
129121|NCT01877304|"~     To compare deposition between two modalities of nebulization~   "
129122|NCT01877291|"~     Background: Smoking is a key factor for development and progression of chronic obstructive~     pulmonary disease (COPD). Although persons with COPD often have concomitant nasal disease,~     there are few studies that report physiological or inflammatory changes in the upper airways~     in young asymptomatic smokers. The investigators investigated physiologic and inflammatory~     changes in the nasal and lower airways of young smokers and if these changes were related to~     smoking history.~      Methods: Seventy-two subjects aged ≤ 35 years (32 healthy nonsmokers and 40 young smokers)~     participated in this study. The investigators measured nasal mucociliary clearance (MCC),~     nasal mucus physical properties, cell count, myeloperoxidase and cytokines concentrations in~     nasal lavage fluid, exhaled breath condensate (EBC) pH and lung function.~   "
129123|NCT01877278|"~     The aim of the study is to evaluate the efficacy of a wearable device using pulse~     electromagnetic fields on pain intensity reduction, measured by visual analogue score (VAS)~     and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), in patients~     affected by osteoarthritis Secondary aim is the evaluate the effect on knee effusion~     reduction, when present and to evaluate pain intensity changes corrected by pain threshold~     measured by pressure algometry.~   "
129124|NCT01877265|"~     This study looks at the amount of LY2605541 in the body after it is injected under the skin.~     The study has 3 periods, each lasting 10 days. Each participant will receive one injection in~     each period. At least 14 days will pass between each injection.~   "
129128|NCT01877213|"~     One third of the costs of medical care for people with diabetes are related to~     hospitalization. Difficult diabetic patient, i.e. those with very high HbA1c, patients >~     75y, those with diabetic foot ulcers, or those with a recent cardiovascular event have a high~     rate of readmission when discharged at home after an initial hospitalization related to~     diabetes or its complications. The objective of the study is to test if a coaching with a~     care coordinating team after hospital discharge would decrease diabetes-related~     rehospitalization rate compared with usual care.~   "
129129|NCT01877200|"~     This study is conducted in Asia. The aim of this non-interventional study is to evaluate the~     the current status of diabetes management, control, and complications in diabetic subjects~     with type 2 diabetes in Bangladesh.~   "
129130|NCT01877187|"~     The purpose of this study is to determine the whether Lipiodol can be used as an imaging~     biomarker, predicting tumor response to therapy in patients with primary and metastatic liver~     cancer. Lipiodol-based transarterial chemoembolization (TACE) has been an accepted standard~     of care procedure for unresectable liver lesions for several decades. Lipiodol is used as a~     carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol~     is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery,~     causing necrosis of the targeted tumor(s). Response to therapy will be evaluated every 1, 3~     and 6 months by clinic visits, MRI/CT/PET scans and blood tests (to include assessment of~     liver function and tumor markers).~   "
129131|NCT01877174|"~     This study will be conducted in up to 10 hospitals in Europe, up to 75 patients will be~     enrolled. The purpose of the study is to evaluate any debris that may be captured in the~     inline filter of the MICHI(TM) Neuroprotection System with Filter (NPS+f) during its use in a~     transcarotid stenting procedure. The MICHI NPS+f is an embolic protection device that uses~     reverse flow to protect the brain during stenting of the Internal Carotid Artery. It is CE~     marked and is used in routine practice for the purpose of this study.~   "
129132|NCT01877161|"~     Repetitive transcranial magnetic stimulation induced virtual lesions for aphasia.~   "
129133|NCT01877148|"~     The present study aims to investigate the effect of transcranial direct current stimulation~     (tDCS) associated with physiotherapy in parkinson´s rehabilitation. Previous studies showed~     that tDCS could reduce the bradykinesia, one of the symptom of Parkinson disease. In this~     way, this study will combine tDCS with physiotherapy in order to enhance the motor~     rehabilitation and the quality of life.~   "
129134|NCT01877135|"~     Evaluation of the 3-years anal carcinoma (AC) incidence in patient with anal AIN3 lesions,~     and factors associated with this AC. A retrospective cohort study will be conducted~     (2000-2013) followed by a prospective cohort study (starting in 2013) with new diagnoses of~     anal AIN3 lesion. The main outcome is histology proven AC. The 3-years incidence rate of AC~     will be calculated. Factors associated with AC will be estimated using a multivariate Cox~     regression model.~   "
129135|NCT01877122|"~     Proflex® Mesh (partially absorbable mesh, Korea) and Marlex® Mesh (heavyweight mesh) will be~     used for inguinal hernia repair to compare the safety and efficacy (pain score, quality of~     life)of two devices at 3 months follow-up.~   "
129136|NCT01877109|"~     The purpose of this study is to establish a model which can predict the treatment outcome and~     the risk of treatment-related morbidity in patients with lymphoma.~   "
129137|NCT01877096|"~     The purpose of this study is to begin to examine the efficacy of a motivational interviewing~     intervention to increase African Americans' screening colonoscopy rates. The results from~     this pilot study will allow us to estimate the magnitude of the intervention and mediation~     effect sizes.~   "
129138|NCT01877083|"~     This is a Phase 2, open-label, safety and activity study of lenvatinib in subjects with~     KIF5B-RET-positive adenocarcinoma of the lung and other confirmed RET translocations. At~     least 20 subjects with KIF5B-RET will be treated and will receive lenvatinib at a starting~     dose of 24 mg orally, once per day. Additional subjects with other RET translocations will be~     treated with lenvatinib at a starting dose of 24 mg orally, once per day. The study will~     consist of 3 phases: The Pretreatment Phase, The Treatment Phase and the Extension Phase. The~     Pretreatment Phase will include screening procedures and eligibility assessments. The~     Pretreatment Phase consists of a Screen 1, Screen 2 and Baseline Period. The Treatment Phase~     will begin when the subject has met all eligibility criteria on Day 1 of the first Treatment~     Cycle. The Treatment Phase contains the Treatment and Follow-up Periods. The Extension Phase~     will begin for subjects who received treatment in the study (either in the Treatment Period~     or Follow-up Period) at the time of database cutoff.~   "
129139|NCT01877070|"~     The purpose of this study is to collect information on how patients and their partners/close~     allies make treatment decisions when they have been diagnosed with early stage prostate~     cancer.~   "
129140|NCT01877057|"~     The increasing prevalence of overweight and obesity among the population contributes to~     increased incidences of chronic metabolic diseases. Healthcare costs related to these~     diseases are rising; prevention or delay of onset of disorders associated with overweight is~     needed. Food ingestion exerts a transient suppressive effect on appetite and further food~     intake by releasing gastrointestinal hormones. Proteins have been shown to be more satiating~     than carbohydrates and fat. Intraduodenal administration (via a naso-duodenal intubation) of~     pea protein has been shown to reduce food intake and increase satiety hormone levels in~     humans, in contrast to orally dosed (unprotected) pea protein. In the present study we aim to~     investigate the effects of human gastric fluid on the degradability of five different~     protected pea protein products. Further, in an ex vivo experiment on freshly obtained human~     duodenum tissue applying Ussing chamber technology; we aim to investigate the intestinal~     satiety hormone release by the five different prototypes. The prototype that is less degraded~     by human gastric fluid and is most effective in intestinal satiety hormone release will be~     used in a future clinical trial.~   "
129159|NCT01876810|"~     The purpose of this study is to investigate the effect of gemfibrozil on nicotine~     reinforcement and cue-elicited craving. Other objectives of this study include screening for~     the ability of gemfibrozil to aid smoking abstinence during a brief quit attempt and~     examining the validity of using laboratory measures of tobacco dependence to predict smoking~     abstinence. It is hypothesized that gemfibrozil will result in diminished nicotine~     reinforcement, an attenuated response to smoking cues, and an increase in smoking abstinence~     compared with placebo. It is also hypothesized that the laboratory measures will prove valid~     in predicting abstinence.~   "
129141|NCT01877044|"~     The higher prevalence of overweight and obesity among the population contributes to increased~     incidences of chronic metabolic diseases. Obesity is considered a low-grade systemic~     inflammatory condition through 1) production of pro-inflammatory cytokines by adipose tissue~     and 2) alterations in intestinal microbiota composition and associated increase in intestinal~     permeability. Healthcare costs related to these diseases are rising; prevention or delay of~     onset of disorders associated with overweight is needed. Administration of wheat~     arabinoxylans (NAXUS), a non-digestible carbohydrate, may change the intestinal microbiota~     composition and have beneficial effects on gut epithelial barrier, especially on permeability~     and innate immune function.~      Objective: To assess the effects of NAXUS on intestinal barrier function, immune system~     performance and metabolic control. Prebiotic properties of NAXUS will be studied. Tolerance~     of the product in different doses will also be investigated.~   "
129142|NCT01877031|"~     We aim to compare the use of ultrasound guidance alone versus a magnetically tracked needle~     to look at the time taken to place a central line, or specifically the time taken to place a~     needle in the internal jugular vein prior to utilizing the Seldinger technique to insert a~     central line.~   "
129143|NCT01877018|"~     The implementation of screening programs for colorectal cancer by screening for fecal occult~     blood has proven effective in reducing the incidence and mortality from this type of~     neoplasms. However, to ensure the efficiency of the programs require population participation~     rates of at least 50%. Experiences in our country show that the population participation is~     far from this recommended minimum number.~      Interventions to promote preventive activities in primary care are well received by the~     population; in the case of colorectal cancer, direct recommendation of primary care~     professionals to carry out the screening is one of the factors with greatest impact on~     increasing population participation in such programs. Care overload, circuit design for~     screening without the direct intervention of primary care professionals and the multiplicity~     of tasks that they must face, are elements that influence the low recommendation for~     screening in the target population who consults for any other reason.~      The introduction of specific reminders in electronic medical record (in widespread use in~     primary care), as a tool to facilitate and encourage direct referral by physicians and nurse~     practitioners to perform colorectal cancer screening will mean an increase of at least 10% in~     participation of the target population, increasing the efficiency of screening programs. The~     introduction of this new software tool will have good acceptance and increase compliance with~     recommendations from health professionals.~   "
129144|NCT01877005|"~     Phase II study to assess the efficacy of 6 cycles of oral JAK1/2 inhibitor ruxolitinib in~     patients with advanced Hodgkin's lymphoma for whom no curative option is available.~   "
129145|NCT01876992|"~     The investigators know that metformin works at the level of the cells in the body by acting~     on a protein called Cyclic amine monophosphate- Response Binding Elements (CREB) binding~     protein or Constitutive Reverter of eIF2α Phosphorylation (CREP) Binding Protein (CBP). What~     the investigators do not know is how this process is affected when the dose of the metformin~     is increased or changed.~      Currently the same doses of metformin are often used in both children and adults, but it is~     possible that the dose of metformin should be based on age and weight. Understanding how CBP~     works could potentially help us to tailor metformin treatment individually for patients based~     on their age, weight and CBP response.~   "
129146|NCT01876979|"~     Determining the cost effectiveness, based on the time duration of application, of two methods~     of wiring the jaws together during surgery to repair mandible fractures. One technique is~     more expensive but faster in application, while the other is less expensive and takes more~     time to apply.~   "
129147|NCT01876966|"~     The purpose of this study is to investigate the pharmacokinetic interaction between~     etravirine and artemether/lumefantrine and darunavir/ritonavir and artemether/lumefantrine in~     healthy Human Immunodeficiency Virus- (HIV-)negative patients. 'Pharmacokinetic interaction'~     means that one medication can influence the absorption and elimination from the body of the~     other medication.~   "
129148|NCT01876953|"~     This phase I/II trial studies the side effects and best dose of dasatinib when given together~     with cytarabine and idarubicin hydrochloride and to see how well they work in treating~     patients with acute myeloid leukemia that is likely to come back or spread. Dasatinib may~     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs~     used in chemotherapy, such as cytarabine and idarubicin hydrochloride, work in different ways~     to stop the growth of cancer cells, either by killing the cells or by stopping them from~     dividing. Giving dasatinib together with cytarabine and idarubicin hydrochloride may be a~     better treatment for acute myeloid leukemia.~   "
129149|NCT01876940|"~     The goal of this prospective randomized study is to compare the effect of operator experience~     on the ability to use fiberoptic-guided intubation in children less than two years old, with~     and without the use of an air-Q as a conduit. The question the investigators are trying to~     answer is: Does the operator experience make a significant difference in the time for~     successful fiberoptic guided tracheal intubation with and without the use of an air-Q~     intubating laryngeal airway?~   "
129150|NCT01876927|"~     Study design:~      Multicenter, randomized, open label phase II study Arm A: DOX 4 cycles - Surgery - Follow-up~     Arm B: DOX 2 cycles - Surgery - DOX 2 cycles - Follow-up~      Population:~      Male or female, 18-75 years of age, with a diagnosis of histologically confirmed, potentially~     resectable adenocarcinoma of the stomach.~      Sample Size: Planned sample size is 90 patients, 45 patients for each arm (p0=50%, p1=80%,~     alpha=0.05 (two sides), beta=0.2)~      Treatment Plan:~      Treatment will be administered for 4 and 2 cycles before surgery in arm A and B,~     respectively, and in arm B for a further 2 cycles after surgery unless progression or~     unacceptable toxicity occurs, or a patient refuses treatment. In such cases patients will go~     off treatment. 3-6 weeks after the end of the fourth (arm A) or second (arm B) preoperative~     cycle, patients will undergo surgery.~      After surgery 3-6 weeks from surgery patients in arm B will receive 2 more cycles.~      DOX: Docetaxel 35 mg/m2 day 1 and 8 Oxaliplatin 80 mg/m2 day 1 Capecitabine 750 mg/m2 x 2~     daily for 2 weeks~      Cycles repeated every 3 weeks~      Evaluation criteria: Tumor assessment will be performed according to the RECIST criteria~     (version 1.1).~      Duration of Study:~      Overall study duration: 07/2010- 03/2017 Planned study duration per patient: 5 years~   "
129151|NCT01876914|"~     Diabetic Macular Edema (DME), which can happen as a complication of diabetes, occurs when~     fluid and proteins collect in the macula (the yellow central area of the retina). The fluid~     can cause swelling which in turn can lead to worsening central vision. The purpose of this~     study is to see if the study device (Swept Source Optical Coherence Tomography or SS-OCT) is~     able to diagnose DME as well as an already approved imaging procedure called fluorescein~     angiography (FA). FA is standard of care and would be conducted regardless of study~     participation. The dye used in FA, which can cause allergic reactions in some patients and is~     not used in pregnant women, is not needed with the study device. Another purpose of the study~     is to avoid the risk of administering the FA dye if possible.~   "
129152|NCT01876901|"~     Hypothesis:~      In France, approximately 12,000 new rectal cancers are diagnosed each year. Frequency is one~     and a half times higher in men than in women. The average age of diagnosis is 65. Unlike~     colon cancer, technical management remains challenging with unresolved operating~     difficulties. Morbidity of surgical procedures remains high with a very large number of~     preventive or curative stoma derivations.~      Reference in surgical treatment is total excision of the rectum and its mesentery, followed~     by continuity restoration by immediate coloanal anastomosis (ACAI). In this procedure, rate~     of fistula that results is reported in the literature between 15 and 25%.~      An alternative to ACAI is delayed coloanal anastomosis without reservoir (ACAD). Based on~     retrospective experiences, we form the hypothesis that ACAD offers a much lower rate of~     fistula (<5%) and allows diminution of preventive stoma derivation practice. Morbidity and~     mortality are reduced, and patient's quality of life greatly improved. Direct costs~     (consumables intraoperative, hospitalization, stoma complications) and indirect~     (pocket-fitting stoma) are greatly reduced.~      This study is a multicentre, two arms, phase 2 clinical trial.~   "
129153|NCT01876888|"~     The aims of this study were to perform cultural adaptation of the MedRisk Instrument for~     Measuring Patient Satisfaction With Physical Therapy Care (MRPS) instrument and provide~     information regarding the factor structure, group-level reliability, and criterion-referenced~     validity of the instrument in Turkish speaking patients.~   "
129154|NCT01876875|"~     Low-grade systemic inflammation associated with obesity may worsen the clinical course of~     psoriasis. Both a low-calorie diet and nutritional supplementation have been shown to have an~     impact on the clinical course of psoriasis, including an anti-inflammatory effect of n-3~     polyunsaturated fatty acids (PUFAs). This study aimed to assess the effectiveness of an~     energy-restricted diet, enriched in n-3 PUFAs and poor in n-6 PUFAs, on metabolic markers and~     clinical outcome of obese patients with psoriasis.~      Methods: Forty-four obese patients with mild-to-severe plaque-type psoriasis treated with~     immuno-suppressive drugs were randomized to assume either their usual diet or an~     energy-restricted diet (20 kcal/kg/ideal body weight/day) enriched of n-3 PUFAs (average 2.6~     g/d). All patients continued their immuno-modulating therapy throughout the study. End-point~     measures included anthropometric, biochemical and clinical parameters at baseline, 3 and 6~     months.~   "
129155|NCT01876862|"~     During the ERAMUNE-01 and -02 studies, the HIV-DNA quantification in the PBMCs (Peripheral~     Blood Mononuclear Cells) showed showed that some patients had a very low or undetectable~     reservoir.~      Recent studies showed that a low reservoir is associated to a spontaneous virologic control~     in three specific categories of patients:~        -  Elite Controllers: these rare patients are able to spontaneously maintain an HIV-RNA~          viral load below 50 copies/mL and elevated CD4 counts without any treatment. These~          patients belong to the B27/B57 haplotypes associated to a reduced risk of HIV~          contamination but these haplotypes are very rare in the global population (0,3 %)~        -  Visconti patients: early-treated patients, during the primo-infection stage. After 3~          to 5 years of treatment, these patients are able to maintain an undetectable HIV-RNA~          viral load.~        -  Salto patients: these patients are treated a bit later compared to the Visconti~          cohort, when their CD4 count was above 350 cells/mm3 and their HIV-RNA viral load below~          50 000 copies/mL. The follow-up of these patients showed the same capacity of control of~          the HIV infection for at least 2 years following treatment interruption.~      Taking into account these 3 categories of patients which common characteristics is a low~     reservoir, our objective is to answer the 2 following questions:~        1. Is it possible to discontinue the treatment in chronically-infected patients with a~          normal immune system and with an undetectable HIV-DNA reservoir?~        2. Is a low viral reservoir predictive of a treatment-free remission of the HIV infection~          in chronically-infected patients?~      The main objective of the proof-of-concept ERAMUNE-03 trial is to evaluate the proportion of~     patients in success (i.e. able to maintain a virologic and an immunologic control of the~     infection) after treatment discontinuation, failure is defined as:~        -  An HIV-RNA viral load > 400 copies/mL on 2 consecutive tests starting from Week 4~        -  Or CD4 count < 400 cells/mm3 on 2 consecutive measures starting from Week 4~        -  Or the onset of an AIDS-related event~   "
129156|NCT01876849|"~     The aim of this study is to assess the long-term safety of exenatide in patients with type 2~     diabetes who were treated with exenatide in Study H8O-MC-GWAA (6-month study) or Study~     H8O-MC-GWAD (12-month study). Study H8O-MC-GWAN serves as an open-ended extension to Studies~     H8O-MC-GWAA and H8O-MC-GWAD.~   "
129157|NCT01876836|"~     1. i-gel~        2. C-LMA~      Compare the effect on gastroeosephageal reflux Postoperative complicatios.~   "
129158|NCT01876823|"~     Alzheimer's disease (AD), the most common dementing disorder of later life, is a major cause~     of disability and death in the elderly. Although a number of theoretical causes exist, the~     etiology of AD is still unknown. Consequently, the focus of treatments has been palliative,~     designed to ameliorate AD symptoms. Recent efforts, however, have revealed some surprising~     data suggesting that cholinesterase inhibitors (AchEIs), used over the last decade, and~     recently released memantine (an N-methyl-D-aspartate (NMDA) receptor antagonist), may confer~     protection to neurons. Thus, they may offer a slowing of cognitive decline and/or improvement~     in behavioral symptoms associated with memory impairment.~      Over the last decade, it has been well documented that mild cognitive impairment (MCI)~     increases the risk of conversion to AD and that coincident depression and MCI (Dep-MCI)~     further increases the risk 2 to 3 fold. The primary focus of this line of investigation is to~     treat the very high risk to dement patient population with Dep-MCI, before they develop AD,~     in the hopes of delaying AD onset.~      Memantine had not been studied in DEP-MCI patients. Since treatment of these patients with~     combined antidepressant and AChEIs has been associated with cognitive improvement in pilot~     studies, we explore whether treatment of DEP-MCI with memantine in addition to antidepressant~     treatment would benefit cognitive performance and lead to a low rate of conversion to~     dementia. We evaluate the cognitive and antidepressant benefit of combined open-label~     es-citalopram and memantine treatment over 48 weeks in a DEP-CI sample.~   "
129168|NCT01876693|"~     The purpose of the study is to determine whether prophylactic gastrostomy leads to less~     treatment interruption and provide better quality of life in head and neck cancer patients~     receiving chemoradiotherapy.~   "
129169|NCT01876680|"~     The purpose of this study is to investigate the effects of specific neck/shoulder muscle~     exercises on pain, function, biochemistry and psychological factors in women suffering~     chronic neck/shoulder pain.~   "
129160|NCT01876797|"~     This study is to characterize the pharmacokinetic and pharmacodynamics of ticagrelor and~     prasugrel in healthy Korean male subjects.~      The study is open label, one sequence, crossover design. In period 1, a single oral dose of~     180 mg ticagrelor will be administrated. After at least 7 days washout period, in period 2, a~     single oral dose of 60 mg prasugrel will be administrated.~      After dosing each period, blood sampling for PK and PD assessment will be conducted.~        1. Blood Sampling Times~             1. PK :predose,10 min,15 min,25 min, 0.5,1,1.5,2,2.5,4,6,8,12 and 24h post-dose~             2. PD :predose,15 min,0.5,1,2,4,6,8,12 and 24h post-dose~        2. Bioanalysis~             1. plasma Ticagrelor~             2. plasma AR-C124910XX (active metabolite of ticagrelor)~             3. plasma R-95913 (inactive metabolite of prasugrel)~             4. plasma R-13727 (active metabolite of prasugrel)~        3. Platelet Aggregation Test using turbidometric Method Maximal Platelet Aggregation(MPA)~        4. PK-PD Modeling analysis~   "
129161|NCT01876784|"~     Primary Objective:~      To determine the efficacy (as assessed by progression-free survival [PFS]) of vandetanib when~     compared to placebo in participants with differentiated thyroid cancer that is either locally~     advanced or metastatic who are refractory or unsuitable for radioiodine therapy.~      Secondary Objectives:~        -  To determine the efficacy of vandetanib when compared to placebo in this participant~          population as assessed by efficacy variables including duration of response (DOR),~          objective response rate (ORR), change in tumour size (TS) and overall survival (OS).~        -  To evaluate the pharmacokinetics (PK) of vandetanib in this participant population and~          potentially investigate any influence of participant demography and pathophysiology on~          vandetanib PK.~        -  To demonstrate an improvement in time to worsening of pain (TWP) in participants treated~          with vandetanib when compared to placebo in this participant population.~        -  To evaluate the safety and tolerability of vandetanib treatment in this participant~          population.~   "
129162|NCT01876771|"~     Neuroendocrine tumours (NETs) are rare, slow growing, and diagnosis is often delayed with~     advanced metastases at presentation. In select patient populations, radioisotope therapy with~     Lutetium-177 (Lu-DOTA-TATE) has been shown to be a safe and effective palliative therapy, and~     has been widely used by research groups in Europe. Lu-DOTA-TATE has been used at the Cross~     Cancer Institute to treat more than 200 patients with NETs since August, 2010. This study is~     being done because the Lu-DOTA-TATE treatment was initially given under Health Canada's~     Special Access Programme (SAP), with each individual treatment requiring separate approval.~     Health Canada requested that the investigators conduct a clinical trial with Lu-DOTA-TATE,~     with the goal of receiving approval to use Lu-DOTA-TATE as a marketed treatment agent.~      The purpose of this study is to: 1) assess the efficacy of Lu-DOTA-TATE treatment in patients~     with somatostatin receptor positive tumours; 2) and assess the safety of Lu-DOTA-TATE.~   "
129163|NCT01876758|"~     Although electroconvulsive therapy (ECT) remains the most effective treatment for people with~     severe depression, patients may experience a significant degree of persistent and/or~     permanent memory problems following ECT. Many patients report the memory problems are the~     most disturbing and serious side effect of ECT, and that such effects impact their quality of~     life following treatment and their willingness to consent to further ECT needed to complete a~     treatment course or to maintain remission. New developments in the field of cognitive~     remediation have demonstrated the benefits of cognitive training to improve memory~     performance in various conditions, such as epilepsy. However, these strategies have never~     been applied to help patients regain memory after ECT. The investigators have designed and~     piloted a novel cognitive program specifically targeted to the cognitive effects of ECT,~     based upon a program tailored to people with seizure disorders, a group with memory problems~     very similar to people who undergo ECT. This Memory Training for ECT (Mem-ECT) is designed to~     help cognitive functions that may be compromised following ECT remain relatively preserved.~     In addition, the intervention attempts to help ECT patients quickly regain their general~     memory skills immediately following ECT. Recent results from our preliminary group of~     patients who underwent ECT and memory training at New York Presbyterian shows no overall~     decline in memory function following ECT. On the basis of these promising findings, the~     investigators propose a more rigorous and larger study to confirm whether this novel memory~     training program can help alleviate memory problems associated with ECT.~   "
129164|NCT01876745|"~     This study is conducted in Asia. The aim of the study is to evaluate the safety and efficacy~     of NovoSeven® (activated recombinant factor VII, eptacog alfa (activated)) during bleeding~     episodes and for the prevention of bleeding during surgery/delivery in patients with~     Glanzmann's thrombasthenia (GT)/Glanzmann's disease.~   "
129165|NCT01876732|"~     Vitamin B12 has several important functions in the body, two of which are production of red~     blood cells and the maintenance of a healthy nervous system. When vitamin B12 is deficient,~     abnormal red blood cells form. These cells are called megaloblasts. The end result is a~     decreased number of red blood cells; a condition called anemia. Some symptoms of anemia~     include fatigue, weakness, shortness of breath, and pallor. Vitamin B12 is also important in~     maintaining a healthy nervous system. Nerves are surrounded by an insulating material that~     helps them conduct impulses. Patients with low B12 levels who receive this vitamin in~     injection form, state that there quality of life is better. Anemia in Hemodialysis patients~     is treated with Epogen, a synthetic material which helps your body make blood cells. The~     investigators believe that if you have a low vitamin B12 level in your blood and the~     investigators give you the vitamin during dialysis your requirement for epogen will be lower~     and you will be able to produce blood cells better. When evaluating for Vitamin B12~     deficiency a special test is needed called methylmalonic acid level (MMA). This is a blood~     test that will be performed and when this level is high and your vitamin B12 level is in the~     low normal range the investigators can make a diagnosis of vitamin B12 deficiency.~   "
129166|NCT01876719|"~     This is a multicenter, multiple dose, randomized, double-blind, placebo-controlled, forced~     titration study. Patients will be randomized to 1 of 4 treatment groups in a 1:1:1:1 ratio.~     One-hundred twenty (120) patients are planned to be randomized. Each patient will receive~     AR08 (0.5, 1, or 2 mg per day) or matching placebo for seven (7) weeks.~   "
129167|NCT01876706|"~     The purpose of the study is to evaluate procedure tolerability and surgical recovery~     following the UroLift® system procedure when conducted with local anesthesia in subjects with~     symptomatic benign hyperplasia (BPH). Primary effectiveness will be achieved by looking at~     the Quality of Recovery Visual Analog Scale (QoR VAS) by the one month follow-up visit.~   "
129170|NCT01876667|"~     Clinical pharmacy specialists are in an ideal position to assist medical teams in the~     management of patients with ischemic stroke. Given their extensive and specialized knowledge~     regarding medication efficacy, safety, and cost-effective use as well as their ability to~     critically review, interpret and apply the results from clinical studies to patient care,~     clinical pharmacy specialists have the potential to have a significant impact on stroke care~     delivery. There are numerous opportunities for clinical pharmacy specialists to become more~     extensively involved in the delivery of care to these high-risk patients. However, to-date~     there are few studies demonstrating the impact of clinical pharmacy specialists on outcomes~     of patients with stroke Stroke is the third leading cause of death in the United States~     (U.S.) and the most common life-threatening neurologic disorder.1 Stroke is a leading cause~     of long-term disability and results in significant individual and societal financial burdens.~     In 2006, stroke accounted for 1 of every 18 deaths and ischemic stroke accounted for 87% of~     all strokes.1 In the U.S., out of the approximately 795,000 people who develop a stroke each~     year, approximately 185,000 (23%) are recurrent events.1 After the first year, the average~     annual risk for recurrent stroke is 4%.2 Patients who survive at least 30 days after a~     first-ever stroke, have an average annual risk of death of 9.1%, much of the risk due to~     nonstroke cardiovascular disease.~      Despite the evidence supporting the use of various therapeutic interventions within the~     ischemic stroke population, a significant proportion of patients continue to have~     uncontrolled risk factors and remain undertreated.26-30 A recent prospective study of more~     than 4933 high-risk patients reported that, as compared to patients with coronary artery~     disease, patients with cerebrovascular disease are undertreated and thus less likely to~     achieve blood pressure (45.3% vs. 57.3%; p<0.001) and lipid (19.4% vs. 30.5%; p<0.001)~     targets.28 Although the reasons for the so-called treatment gap have not been explored~     specifically within this population, data from studies within the coronary artery disease~     population suggest that provider, patient and health care system factors likely all~     contribute.~      This will be the first, prospective, randomized study to evaluate the impact of a clinical~     pharmacist disease management program on both surrogate and clinical outcomes for patients~     with non-cardioembolic ischemic stroke.~      This will be a randomized, controlled study comparing a clinical pharmacist-led disease~     management intervention by the Clinical Pharmacy Cardiac Risk Service (CPCRS) to usual care~     (UC).~   "
129171|NCT01876654|"~     Patient specific instrumentation is an alternative to conventional intra- and extra-medullary~     guides to perform the femoral and tibial cuts in total knee replacement (TKR).~      This instrumentation could provide a better alignment of a TKR, reduce blood losses and~     operative time, and improve clinical outcomes.~      The primary goal of this study is to compare the femorotibial mismatch angle of two groups of~     patients: patients undergoing posterior stabilized, fixed bearing TKR with conventional~     Attune® instrumentation (DePuy Johnson & Johnson, Warsaw, Indiana), versus patient undergoing~     TKR with the TruMatch® (DePuy Johnson & Johnson, Warsaw, Indiana) cutting guide.~   "
129172|NCT01876641|"~     The purpose of this study is to see if the combination of Vemurafenib with Decitabine plus~     Cobimetinib improves the low therapy response rate in subjects with malignant melanoma.~   "
129173|NCT01876628|"~     The aim of this study is to see whether the addition of Clindamycin, a protein inhibiting~     antibiotic, to the standard antibiotic treatment of limb cellulitis, with Flucloxacillin,~     results in less tissue damage and a more rapid resolution of both systemic and local~     features, in a cost-effective manner. This study is a randomised controlled trial comparing~     Clindamycin with placebo.~   "
129174|NCT01876615|"~     The objective of this study is to compare pharmacokinetics after single oral administration~     of YH4808 and Diclofenac each separately versus coadministration of YH4808 and Diclofenac in~     healthy male volunteers~   "
129175|NCT01876602|"~     The specific aims of this study are to: 1) evaluate the impact of a novel intervention~     delivered via school-based physical education (PE) on adolescents who have a high sensitivity~     to exercise-induced negative affect; 2) determine whether adolescents' tendency to feel~     uncomfortable during exercise is a stable trait that persists even in the face of an~     intervention; and 3) compare and contrast three alternative methods of measuring adolescents'~     sensitivity to exercise-induced affect.~      Healthy middle-school students who do not participate in team or individual competitive~     sports will be recruited and assessed to determine their existing predisposition toward~     exercise (i.e., reluctant exercisers and latent exercisers). The assessment will be~     conducted using three methods that have been used to measure individuals' propensity to~     experience positive affect in the face of a stimulus: 1) a pencil-and-paper assessment that~     measures tendency to respond to a challenge with positive affect; 2) electroencephalogram~     (EEG) to ascertain frontal cortical asymmetry; and 3) empirically assessed affective response~     to a standardized exercise task. Reluctant and latent exercisers will be assigned in equal~     numbers to one of two conditions. One condition will implement a PE-based intervention that~     differs from the traditional approach in that students will be instructed to exercise at an~     intensity that has been determined to elicit positive affect in that individual (based on~     baseline testing). In the other condition, students will be instructed to exercise at an~     intensity derived from standard formulas typically used in exercise prescriptions. It is~     hypothesized that the non-traditional approach will increase reluctant exercisers' enjoyment~     of PE and also their level of participation in physical activity outside of PE. The latter~     will be determined using portable monitors (accelerometers) worn at baseline, after the~     intervention, and again 1 year after the end of the intervention.~   "
129176|NCT01876589|"~     The purpose of this study is to examine the improvement of myocardial blood flow induced by~     regained vasomotor functions of the stented coronary segment after resorption of BVS over~     time.~   "
129177|NCT01876576|"~     This study will evaluate the expansion of dietary options from clear liquids the entire day~     to a low reside breakfast and lunch for patients prior to undergoing bowel preparation with~     MoviPrep® and its effect on preparation quality for colonoscopy.~   "
129178|NCT01876563|"~     The aim of this study is the comparision between the effects of vitamin D or placebo~     supplementation for 2 months in serum level of thioredoxin, TBP-2 and thioredoxin reductase~     activity in patients with type 2 diabetes~   "
129179|NCT01876550|"~     The primary objective of this study is to determine the comparability of the safety and~     efficacy of Mupirocin Calcium Cream, 2% and Bactroban® Cream in subjects with secondarily~     infected traumatic skin lesions. It will also be determined whether the efficacy of each of~     the active treatments is superior to that of the vehicle cream (placebo).~   "
129180|NCT01876537|"~     THEME RELEVANCE. Sacrococcygeal pilonidal sinus disease (SPD) is a congenital disease that's~     well spread and constitutes 1-2% of all surgical pathologies. In all Coloproctological~     pathologies, the disease composes 14-20% (G.I. Vorobjov, 2006; V.D. Fedorov, 2005; Gupta P.J.~     et al., 2005). Clinical manifestations of pilonidal sinus disease mainly due to the~     appearance of inflammation in it.~      The main approach in the complex treatment of this group of patients is to execute radical~     surgery. The guiding principles in it are adequate sanation and drainage of purulent focus.~      Despite the fact that this disease is the subject of numerous medical journals, monographs,~     research works, masters and doctoral theses, frequency of unsatisfactory outcomes remains~     high (recurrence - from 10% to 19%, wound inflammation - 20-30%). In this case terms of~     stationary and out-patient treatment increase till 30-70 days (G.I. Vorobjov, 2006; B.M.~     Dacenko et al., 2004; Cubukcu А., 2001, Perruchoud С, 2002).~      The frequency of unsatisfactory results after excision of SPD directly depends on the kind of~     surgery. After palliative surgery (incision and drainage of abscess) in 11.7 - 25.2% of~     patients occurs recurrence of the disease (McCallum I., King P.M., Bruce J., 2007;), for the~     open wound healing recurrence occur in 3-8% of the operated. For primary wound healing in~     7,5-9,7% required re-surgery (V.K. An, 2003; A.A. Kartashev, 2011).~      Sacrococcygeal pilonidal sinus disease overwhelmingly affects people, mostly young working~     age, and treatment failure leads to long-term temporary disability of patients.~      In the last few years continue to discuss methods of one-time or multi-stage radical surgical~     treatment of pilonidal sinus, but to date there is no single approach to the choice of~     surgical treatment for this disease (V.L. Denisenko, 2008).~      Success of surgical treatment of SPD depends on the development and introduction of new~     devices and techniques exist to produce convergence and immobilization of the wound edges,~     thereby obtaining its primary healing and a significant reduction of wound surface.~      The high frequency of the disease and postoperative complications, as well as long-term~     temporary disability of patients demonstrates the relevance of the development of modern~     methods of radical surgery of sacrococcygeal pilonidal sinus disease (V.I. Pomazkin, 2008).~      AIM OF RESEARCH. The aim of our research is to improve the results of complex radical~     surgical treatment of patients of sacrococcygeal pilonidal sinus disease through the~     development and introduction of new devices and techniques for convergence and immobilization~     wound edges.~      TASKS OF RESEARCH.~        1. To conduct a comparative analysis the most common surgical treatment of SPD in the~          frequency of complications in the intra- and postoperative periods.~        2. To develop a device for convergence and immobilization wound edges in patients with SPD.~        3. To analyze the effectiveness of the developed techniques and devices in comparison with~          traditional surgical treatment.~        4. To make practical recommendations on the options and methods of using the developed~          methods and devices.~      NOVELTY OF RESEARCH. For the first time, based on the design and creation of an~     approximation-immobilization device (RU Patent № 112020, Bull. № 1, 01.10.2012) will be~     improved the surgical treatment of patients with this pathology, clinical and anatomical~     study of the proposed device for different configurations of gluteal-sacrococcygeal region,~     as well as the analysis and justification of the basic parameters of wound (length, depth and~     width of the wound, the number of stitches, the complication rate , the area of the wound).~      Developed a method of closure of the wound defect after radical excision of pilonidal sinus~     by Krivonosov-Brezhnev (RU Patent № 2,464,943, Bull. № 30 from 10.27.12.), that significantly~     reduces the risk of postoperative complications in patients with acute inflammation of the~     SPD.~      For the first time an analysis of postoperative period in patients operated with the proposed~     methods compared with traditional methods of surgery was performed.~      POSSIBLE APPLICATION AREAS. Results of the research designed for use in the treatment process~     of coloproctological departments at all levels, as well as the learning process of medical~     schools.~      EXPECTED EFFECTIVENESS.~        1. Scientific and technical effect: developed new techniques and devices for convergence~          and immobilization wound edges used for the treatment patients with SPD.~        2. Medical and social effects: the introduction into clinical practice of the developed~          techniques and devices will improve the results of surgical treatment of patients with~          SPD by rigid fixation of wound edges, by reducing the time of postoperative wound~          healing, by decreasing the risk of complications in the early postoperative period.~   "
129181|NCT01876524|"~     The purpose of this study is to study the efficacy and security of noninvasive brain~     stimulation as a new approach for patients with Substance Use Disorders (SUDs) plus other~     psychiatric conditions like ADHD, Schizophrenia, Bipolar disorder, etc.~   "
129182|NCT01876511|"~     This study will be looking at whether MK-3475 (an antibody that blocks negative signals to T~     cells) is effective (anti-tumor activity) and safe in three different patient populations.~     These include: 1. patients with MSI positive colon cancer, 2. patients with MSI negative~     colon cancer 3. patients with other MSI positive cancers, and 4. patients with MSI negative~     cancer with a mutator phenotype.~   "
129183|NCT01876498|"~     The purpose of this study is the validation of the Brief Michigan Hand Questionnaire by~     patient with Morbus Dupuytren and to build up a register.~   "
129257|NCT01875536|"~     Given previous evidence that non invasive brain stimulation enhances the effects of~     conventional therapies, this randomized sham-controlled trial with 4-weeks follow-up aimed to~     determine if the repetitive transcranial magnetic stimulation (rTMS)combined with~     conventional physical therapy (VRT) would be superior to physical therapy in improving upper~     limb function and quality of life with chronic stroke individuals.~   "
129340|NCT01874418|"~     The purpose of our study is to investigate CSF and blood biomarkers among the subjects with~     mild cognitive impairment (MCI) and Alzheimer's disease (AD) as well as normal controls.~   "
129184|NCT01876485|"~     This hybrid effectiveness/implementation trial will be conducted in two phases over four~     years. In Phase 1, the investigators will evaluate the process of implementing a~     collaborative, diabetes goal-setting intervention (Empowering Patients in Chronic Care~     [EPIC]) personalized to self-reported patient activation and functional health literacy (FHL)~     levels into routine primary care practices. In Phase 2, the investigators will conduct a~     randomized, clinical trial to compare the effectiveness of EPIC to enhanced usual care (EUC).~     In Phase 2, the investigators will conduct a randomized clinical trial enrolling 284 Veterans~     with poorly controlled diabetes defined by average hemoglobin A1c over the last six months of~     >= 8% to receive EPIC or enhanced usual care (EUC). Consented subjects will be allocated~     evenly between EPIC and EUC. EPIC consists of six 1-hour group sessions focusing on 1) Your~     Health, Your Values, 2) Diabetes ABCs, 3) Setting Goals and Making Action Plans, 4)~     Communication with Your Health Care Provider, 5) Staying Committed to Your Goals, and 6)~     Reviewing and Planning for the Future. After each group session, a one-on-one session between~     a designated PACT member and patient participants will focus on collaborative goal-setting.~     Patients randomized to EUC will be referred to the PACT RN Care Manager for diabetes~     management, and will also receive a packet of educational materials regarding diabetes~     management, including a letter delineating the diabetes management resources available at~     their facility. Study measurements using self-reported questionnaires and blood tests to~     assess blood sugar control will be obtained at baseline, post-intervention, and post-six~     month maintenance period.~   "
129185|NCT01876472|"~     Adult recipients of cochlear implants (CI) generally loose interest in listening to music.~     This may be due to the rather limited spectral resolution of CI. However, child~     CI-recipients, if offered the opportunity, like to listen to music. They participate actively~     in musical acitivities, such as singing, dancing or playing an instrument. Thus, there seems~     to be a fundamental difference in the music perception of people who receive CI as child or~     as adult.~      This study assesses music perception skills of child, teen and adult cochlear implant~     recipients in settings with simple tone sequences and in a more complex, melodious context.~   "
129186|NCT01876459|"~     Patients with memory disorders are experiencing different trends which are difficult to~     predict. Moreover, the distinction between Lewy body disease and Alzheimer's disease is not~     easy as both diseases can present similar symptoms. Nowadays, routine examinations exist and~     can improve the diagnosis but there are not specific enough of one of those two pathologies.~      Lewy body disease is characterized by the presence of particular structures in patient's~     brain, called Lewy body, composed of a protein called alpha-synuclein. The aim of this~     study is to measure the rate of alpha-synuclein in cerebrospinal fluid. This measurement~     could allow us to differentiate patient with Alzheimer's disease from those with Lewy body~     disease.~   "
129187|NCT01876446|"~     This phase II trial studies how well pegylated irinotecan NKTR 102 works in treating patients~     with small cell lung cancer that has returned after a period of improvement. Pegylated~     irinotecan NKTR 102 may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth.~   "
129188|NCT01876433|"~     Objective: The objective of the study is to assess the structural and functional cardiac~     effects of treatment with the beta 3 AR agonist Mirabegron in patients with chronic heart~     failure.~      Design: We are planning a study aiming at establishing proof of concept that treatment of~     patients with HF with Mirabegron has significant positive effects, as assessed by clinical~     and biochemistry measurements, but not by hard endpoints. We are performing a combined~     dose-finding - chronic efficacy study.~      The study is a randomized, placebo‐controlled, double‐blinded trial. The follow‐up period is~     6 months. 70 patients with chronic heartfailure will be included.~      Specific aims~        1. Determine safety of administration of Mirabegron to patients with heart failure.~        2. Determine if treatment with Mirabegron for 6 months induces beneficial cardiac~          structural remodelling in patients with heart failure.~        3. Determine if Mirabegron improves symptoms and exercise capacity as indicated by~          questionnaires and 6 min walk test in patients with heart failure.~        4. Determine effects of Mirabegron on cardiac conduction, repolarisation and rhythms and~          arrhythmias in patients with heart failure.~        5. Determine effects of Mirabegron on circulating biomarkers in patients with heart~          failure.~   "
129189|NCT01876420|"~     To assess the safety and clinical performance of the CoreValve™ Evolut R™ System.~   "
129190|NCT01876407|"~     The purpose of this study is to evaluate the effectiveness of using to low intensity laser as~     an intervention against preventive and therapeutic oral mucositis induced by radiotherapy and~     chemotherapy.~   "
129191|NCT01876394|"~     The purpose of the study is to examine the effect of consuming 50g of fat from 5 different~     sources (coconut, canola, grapeseed, chia, and butter) on arterial stiffness, blood pressure~     and blood glucose levels. It is hypothesized that butter will have the most detrimental~     effect on acute vascular function. Canola, grapeseed and chia oil with their decreased~     content of SFA are hypothesized to impair vascular function to a lesser extent.~   "
129192|NCT01876381|"~     To investigate the safety, pharmacokinetics, pharmacodynamics, and efficacy of OPC-41061 in~     patients with chronic renal failure undergoing hemodialysis or hemodiafiltration using~     variables, such as daily urine volume and increase in interval body weights between~     hemodialysis or hemodiafiltration, in 4-day intermittant administration (excluding the days~     of hemodialysis or hemodiafiltration) at the dose fixed during the dose-escalation period~   "
129193|NCT01876368|"~     This study will assess the efficacy and safety of LCZ696 in comparison to olmesartan in~     essential hypertensive patients not adequately responsive to olmesartan~   "
129236|NCT01875809|"~     Despite a rapidly increasing number of renal denervation (RDN) procedures, only little is~     known regarding the patient or procedural characteristics influencing the outcome. None of~     the detectable variables like number of ablation points, temperature rise, impedance drop,~     have been shown to correlate with the blood pressure (BP) reduction. In this study, the~     investigators assess different patient and procedural characteristics, like exact patient~     medication, stress hormones, heart rate variability, and focus on the change of the~     catecholamine spill-over, and the impact on BP and heart rate after RDN and after EP~     ablation. The investigators hypothesize the correlation between reduction of catecholamine~     spill-over due to denervation and the BP reduction. In this study, the investigators will~     assess 40 patients undergoing RDN and 40 patients undergoing EP ablation.~   "
129194|NCT01876355|"~     Rationale: Delirium is highly prevalent in the ICU. GABA-ergic anaesthetics may provoke~     delirium. Alpha-2-adrenergic agonists may lead to a reduction of the total amount of~     GABA-ergic anaesthetics and reduction of delirium. There are no large studies proving that~     this therapy is effective and safe.~      Objective: The objective of this study is to compare the effect of clonidine with placebo on~     the occurrence and duration of delirium in mechanically ventilated ICU patients.~      Study design: Prospective randomised double-blind placebo controlled intervention study in~     115 patients.~      Study population: All patients >18 years old, intubated mechanically ventilated and sedated~     at inclusion.~      Intervention: Clonidine infusion of 0,25 mcg/kg/h added to the standard sedation regimen.~     Comparison: NaCl 0,9 % infusion as placebo.~      Main study parameters/endpoints: The main study parameter is the total number of awake and~     delirium-free observation periods the first 7 days after randomisation. An observation period~     is a nursing shift of 8 hours.~   "
129195|NCT01876342|"~     Sportsman's hernia causes chronic groin pain in physically active adults. Open hernia repair~     without mesh or laparoscopic technique with mesh have been advocated in the treatment of~     sportsman's hernia. The aim of this randomized study is to compare the effectiveness of open~     technique to laparoscopic technique for the treatment of Sportsman´s hernia. The hypothesis~     is that laparoscopic technique is less painfull than open surgery for repair of sportsman's~     hernia.~   "
129196|NCT01876329|"~     A review of the literature reveals that very few studies have assessed the potential~     co-existence of vitamin B12 deficiency due to gastric parietal cell autoantibodies. While~     Segal et al. in 2004 published a study which found that 49% of patients with RA had vitamin~     B12 deficiency, no assessment of the etiology or the presence of autoantibodies was made.~     While Goeldner et al. in 2011 and Datta et al. in 1990 demonstrated that anti-gastric~     parietal cell antibodies (anti-GPC Ab) were found in <5% to 28% of RA patients respectively,~     no additional testing was implemented to determine the significance, specifically whether or~     not the presence of anti-GPC Ab related to vitamin B12 deficiency.~      The purpose of this study is to determine the prevalence and metabolic significance of~     anti-GPC Ab in three cohorts: (1) a group of patients with Rheumatoid Arthritis, (2) a group~     of patients with autoimmune thyroid disease (AITD), and (3) a group of patients with neither~     RA or AITD. To determine the significance of the presence of anti-GPC Ab, testing of the~     current serum B12 level along with a metabolite dependent on adequate vitamin B12 levels~     (Methylmalonic acid) will be tested.~   "
129197|NCT01876316|"~     The Effect of Ethnic on Moxifloxacin Induced QT Interval Prolongation in Korean and Japanese~     Healthy Subjects~   "
129198|NCT01876303|"~     This clinical trial studies genetic biomarkers from saliva samples in patients with Ewing~     sarcoma. Studying samples of saliva from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify~     biomarkers related to cancer.~   "
129199|NCT01876290|"~     The investigators want to test if it is indicated to associate dexamethasone and ondansetron~     in obese patients having bariatric surgery under total intra-venous closed-loop anesthesia.~   "
129200|NCT01876277|"~     In adolescence, the effects of cancer and its treatment can lead to bodily changes such as~     hair loss, weight loss or gain, amputations, scars and developmental delay. As treatments for~     childhood cancers improve and life expectancy increases, more adolescents have to deal with~     the effects of cancer and the treatment on their bodies throughout their lives.~      Body image can be defined as The mental image we hold of our bodies. There are two aspects~     to this, how we see our size/shape/weight etc, and then how we feel about this. Often the~     actual change in body does not always predict how people cope with it, or how they feel about~     it.~      Prior research suggests, and clinical experiences suggests that body image issues arise for~     at least some adolescents with cancer, however it is unknown whether a disturbance in body~     image is seen as distressing for the adolescent, or how this affects them psychologically.~      Body image problems were always seen as a typically female problem, and therefore researchers~     have often neglected to look at the issues for men. There is currently no research~     specifically addressing the impact of body image in adolescent boys with cancer.~      This research will involve interviewing adolescent males with cancer with the aims to find~     out;~        1. What the body image issues are, if any for this group.~        2. How any body image issues might affect them, particularly psychologically.~        3. What helps or hinders this group maintain a positive body image, or stop it having a~          negative impact on them psychologically.~      It is hoped that this will help to inform psychological treatments for body image~     difficulties in the future.~   "
129201|NCT01876264|"~     The trial will investigate if removing an additional length of small bowel will result in~     lower risk of recurrence at the surgical join (anastomosis), thereby decreasing the need for~     further surgery in the future.~   "
129202|NCT01876251|"~     This study is aimed to determine the tolerability of the PF-03084014 plus docetaxel~     combination in patients with advanced breast cancer. Preliminary information about the~     efficacy of the combination will also be collected.~   "
129203|NCT01876238|"~     This research study will examine how patients with advanced breast cancer and their oncology~     team communicate and plan ongoing care.The purpose of this study is to find out more about~     care planning during advanced breast cancer. The study will see if certain aspects of~     communication make a difference in how patients understand their illness.~   "
129204|NCT01876225|"~     The use of forced coughing during cervical punch biopsy may reduce pain & discomfort~     associated with the procedure.~   "
129214|NCT01876095|"~     Nursing home residents are among the frailest patient groups with a high number of~     co-morbidities and a high use of medicines. Inappropriate polypharmacy (i.e. often~     overprescribing) is one of the major problems in the nursing home population increasing the~     number of adverse drug reactions, falls, hospital admissions, mortality as well as having an~     impact on health care utilization. Multidisciplinary medication reviews have a great~     potential to reduce inappropriate medication use. The purpose of this study is to determine~     the efficacy of a multidisciplinary medication review model focussing on discontinuing~     inappropriate medication in a cluster randomized controlled trial in 600 nursing home~     residents. The primary outcome measure is the difference in proportion of residents who~     successfully discontinued medication between intervention and control group after four~     months. Secondary outcome measures will be the drug burden index, adverse drug withdrawal~     events related to the discontinued medication, death, referral to hospitals and quality of~     life.~   "
129205|NCT01876212|"~     Current therapeutic approaches available for patients with advanced-stage melanoma remain~     inadequate, and existing approaches including those involving immunotherapy with cytokines~     and/or targeted strategies have resulted in disappointingly low rates of durable and complete~     responses. Correcting immune dysfunction in advanced-stage melanoma patients using~     tyrosine-kinase inhibitor (TKI) such as dasatinib is proposed to relicense the patient's~     immune system to respond optimally to specific immunization. The integration of antigens~     expressed by tumor-associated blood vessel cells provides a means to selectively target the~     genetically-/antigenically-heterogeneous population of tumor cells in the advanced-stage~     melanoma patient.~      This is a single-center, prospective randomized Phase 2 trial evaluating the activity, safety~     and immune effects of dasatinib given in combination with an autologous type-1 polarized~     Dendritic Cell (αDC1) vaccine. The current trial represents a randomized Phase 2 study to~     determine the activity and safety of intradermal (id) administration of αDC1s loaded with a~     mixture of six TBVA-derived peptides at the time of, or immediately after, an initial therapy~     cycle with the TKI dasatinib.~      Dasatinib will be administered at the standard dose and schedule recommended by the FDA (70~     mg BID). The autologous type-I DC vaccine will be administered either prior to, or~     concomitant with, the initiation of dasatinib administration. All patients will receive~     dasatinib at a starting dose of 70 mg twice daily by mouth in the outpatient setting~     approximately every 12 hours, at the same time each day.~      The DC vaccine will be administered by a single intradermal injection of approximately 10e7~     cells, with all the DCs being administered on days 1 and 15 of every cycle on an outpatient~     basis in the University of Pittsburgh Clinical and Translational Research Center (UPCI-CTRC).~      Patients on Arm A will start dasatinib administration on cycle 2, day 1 (week 5), while those~     patients in Arm B will start dasatinib administration on cycle 1, day 1 (week 1).~      Men and women at least 18 years of age must be HLA-A2+ and have histologically confirmed~     melanoma that is metastatic (Stage IV) or unresectable Stage IIIB/C and for which standard~     curative or palliative measures do not exist or are no longer effective.~   "
129206|NCT01876199|"~     In this research, the investigators want to see if early detection of HIV infection can be~     improved by testing young adults who seek urgent health care from pharmacies and healthcare~     facilities with symptoms similar to those people get with recent HIV infection.~      Specific objectives:~        1. What proportion of people presenting with these symptoms are HIV positive at the point~          of seeking urgent health care?~        2. What proportion of those who test negative or where the result is unclear (one rapid~          test positive and one negative) at first rapid HIV testing, will test positive two weeks~          later?~        3. What is the best way (SMS, phone call or home visit) to remind people to come for the~          second test after two weeks?~        4. Will young adults who seek urgent health care for fever, body pains, diarrhoea or an STD~          from pharmacies or health facilities find it acceptable to be invited for an HIV-1 test~          at the time of health care seeking?~      Hypotheses~        1. Targeted screening for AHI among patients seeking health care for symptoms compatible~          with AHI or sexually transmitted disease (STD) will identify AHI cases in more than 1%~          of those screened.~        2. Intense follow-up of patients evaluated for AHI will improve rates of repeat HIV-1~          testing 2-4 weeks after initial health-care seeking, relative to standard practice~          (i.e., recommendation to return for testing on a given date).~   "
129207|NCT01876186|"~     To investigate whether prolonged period of treatment (6 months) can have a better therapeutic~     outcome than conventional period (3 months) of antimuscarinics.~   "
129208|NCT01876173|"~     Sudden cardiac death (SCD) due to a ventricular arrhythmia is a serious cause of~     cardiovascular death in Canada. The implantable cardioverter defibrillator (ICD) offers~     high-risk patients a treatment option to reduce the incidence of SCD by delivering an~     internal shock to restore a normal rhythm, if needed. Definitive evidence has established the~     effectiveness of the ICD for reducing mortality when used as prophylaxis for SCD (a primary~     prevention indication). Approximately 3,700 new candidates accrue annually. Practice~     guidelines define the criteria to determine patient ICD candidacy for primary prevention.~     However, in addition to SCD risk, ICD candidates may have chronic diseases such as diabetes,~     renal insufficiency, hypertension, and atrial fibrillation. Thus, balancing the benefits and~     risks of an ICD can become complex, particularly when competing mortality risks are present.~     Research has recognized human costs associated with device complications and shocks affecting~     psychological, health related quality of life (HRQL), and morbidity outcomes. The~     complexities surrounding the long-term benefits/risks, complications, replacements, and~     shocks, warrant decision support to prepare patients to make decisions. In Canada, there is~     no clear framework to support patients' decision-making in the context of ICD treatment~     options. Decision support, using a decision aid, could moderate treatment related uncertainty~     and prepare patients to make active, informed, quality decisions.~      Objectives: 1) develop a decision aid for ICD candidates to support quality decision-making~     (informed, deliberate, values-based choices), 2) to evaluate the decision aid, and 3) to~     determine the feasibility of conducting a trial.~   "
129209|NCT01876160|"~     The sensory and motor perception thresholds can influence the therapeutic effects of~     Transcutaneous Electrical Nerve Stimulation. This study aimed to determine the threshold of~     sensory perception and the threshold of motor response in young and elderly subjects of both~     sexes. Eighty healthy volunteers were evaluated; 40 women and 40 men divided into two equal~     groups of young and elderly subjects. Half of the individuals in each group were stimulated~     with 5 and 50Hz frequency, with pulse duration of 20, 100, 400, 1000 and 3000µs applied on~     the flexor muscle bellies of the wrist and fingers. The threshold of sensory perception was~     identified as the first sensation of increased current intensity and the threshold of motor~     response as the minimum muscle contraction detected. The results were submitted to ANOVA~     test, followed by the Tukey test, with a significance level of 5%.~   "
129210|NCT01876147|"~     Vision testing is a fundamental part of every optometry and ophthalmology assessment.~     Traditional vision testing charts are not able to measure vision below a certain level.~     Vision in this range is classified as counting fingers (CF), hand movements (HM) and light~     perception (LP). These measures are not very accurate or easily quantifiable. They are also~     poorly understood in terms of impact on quality of life. This study aims to assess new~     methods for measuring the vision of patients with very low vision.~   "
129211|NCT01876134|"~     Acute kidney injury (AKI) is a common heterogeneous disease that complicates several medical~     and surgical conditions. Recent studies have demonstrated that the occurrence of AKI~     significantly increase the risk of adverse outcomes. Despite the advanced in modern medicine,~     the interventions for AKI are not improved. One major reason of the failure to shift~     therapeutic progress is the clinicians' widespread dependence upon serum creatinine, an~     unreliable marker during acute changes of renal function, for the diagnosis of AKI.~      In the past decade, over 20 unique biomarkers of AKI had been explored. Among them,~     neutrophil gelatinase-associated lipocalin (NGAL), interleukin-18 (IL-18), and kidney injury~     molecule-1 (KIM-1) have received the most interest. None of them, however, is an idea one.~      Cysteine-rich protein 61 (Cyr61), a secreted matrix-associated heparin-binding protein,~     belongs to the CCN family. It regulates a broad spectrum of cellular activities, including~     cell adhesion, migration, proliferation, survival, differentiation, apoptosis, angiogenesis,~     and extracellular matrix production of multiple cell types. By the kidney~     ischemic/reperfusion injury animal model, Cyr61 gene was found to be rapidly up-regulated in~     the renal outer medulla. That portion of the kidney is corresponding to the area of~     marginally oxygenated under normal condition and most tubular injury following renal~     ischemic/reperfusion injury.18 Elevation of Cyr61 protein was detected in the kidney and also~     in urine following injury, making it a potential marker of AKI.~      Additionally, pulse diagnosis is an integrative part of traditional Chinese medicine. With~     spectral analysis of the pulse waves, researchers started to observe the pulse wave~     harmonics. An in vivo study of rats revealed that ligating one or both of the renal arteries~     significantly reduced the second harmonic component of the pressure pulse at the caudate~     artery. Ligating the artery toward the spleen prominently reduced the third harmonics~     component of the pulse. Analysis of the harmonics in the spectrum of the arterial pressure~     wave revealed that individual organs might have their own natural frequencies. These~     observations suggested that individual vascular beds exert independent, frequency-specific,~     effects on the peripheral pressure wave.~      Among different etiologies, cardiac surgery is an important cause of AKI. It has been shown~     that AKI after cardiac surgery is relatively highly prevalent and prognostically important.~     Cardiac surgery is usually performed with the use of extracorporeal cardiopulmonary bypass~     machine ('on-pump').~      Based on the evidence from cell culture study and animal study in the literature, we~     hypothesize that Cyr61 is rapidly increased in the urine after AKI. We thus design this~     project to evaluate study the diagnostic role and clinical application of Cyr61 in AKI. We~     will conduct a prospective cohort study to evaluate the changes of urinary Cyr61 in patients~     undergoing cardiac surgery. Cyr61 may serve a good biomarker for the early diagnosis of~     patients with AKI, either singly or in combination with NGAL. By the way, we also try to~     correlate the changes in those biomarker with a potential new tool：harmonic analysis of~     arterial pressure pulse waves. We have special interest in following the time course of~     changes in biomarker and correlate with changes in pulse analysis. Physiological parameters~     of vascular compliance and regional blood oxygen saturation will be correlated concurrently.~     It is hoped that early detection of AKI will lead to earlier intervention, thus enhancing our~     ability to develop beneficial therapies.~   "
129212|NCT01876121|"~     This study is to assess the safety and efficacy of celecoxib on the pain relief from acute~     pain.~   "
129213|NCT01876108|"~     The role of Helicobacter pylori(HP)in the pathogenesis of non-alcoholic fatty liver disease~     (NAFLD) is controversial.~   "
129237|NCT01875796|"~     This project tests the feasibility and utility of a novel, integrated approach to treatment~     of patients with cannabis use disorder (CUD) and anxiety disorders.~   "
129258|NCT01875523|"~     The study is designed to evaluate the pharmacokinetics, safety and tolerability,~     immunogenicity and pharmacogenetics of a single dose of serelaxin/RLX030 in patients with~     severe renal impairment and end-stage-renal-disease (ESRD) compared to healthy volunteers.~   "
129215|NCT01876082|"~     Desmoids tumors are benign soft tissues tumors characterized by aggressiveness and potential~     local recurrence. There is a female predominance with a sex ratio of 2/1 and median age at~     diagnosis is about 30 years.~      Only a complete surgical excision is recommended in desmoids tumors. Some forms of desmoid~     tumors are recurrent and/or symptomatic and are not accessible to a conservative surgical~     treatment. In these clinical situations, only a medical treatment may achieve tumor control~     and quality of life maintenance. Place of systemic treatments in the management of desmoids~     tumors is poorly evaluated. Regarding chemotherapy, methotrexate and vinblastine protocol is~     actually the best evaluated combination, which allowed observing objective response rate~     between 40 and 75%. Toxicity was mainly marked by the risk of haematological toxicity.~      Pazopanib is an inhibitor of multi-target tyrosine kinase, in oral form, with selective type~     receptors -1, -2 and -3 of VEGF receptors on the PDGFA and B, and c-Kit. It is currently~     under clinical development in humans in the treatment of several tumor types.~   "
129216|NCT01876069|"~     Background:~      Pancreatic cancer is associated with a poor prognosis. Therefore, rapid and accurate~     diagnosis of a pancreatic mass is important to direct patient management. Endoscopic~     ultrasonography-guided fine needle aspiration (EUS-FNA) is the current standard for sampling~     pancreatic mass lesions, with diagnostic accuracy of 78% to 95%. But, the EUS-FNA has some~     limitations include stromal cell tumors and lymphomas may be difficult to diagnose. To~     overcome these limitations, a new needle device with ProCore reverse-bevel technology was~     developed recently.~      Aims:~      The objective of this prospective study is to compare the rate of diagnostic sufficiency in~     the EUS sampling by using newly developed ProCore needle with conventional FNA needle in~     suspected unresectable pancreatic cancer. We will also compare the safety, the yield of~     histologic core tissue and the cost-effectiveness between these modalities.~   "
129217|NCT01876056|"~     While Cognitive behavior therapy for psychosis (CBTp) is now established as an effective and~     evidence based therapy for psychotic illnesses in the west and is recommended by the national~     organizations both in Europe and in the USA. However, CBT remains limited to the western~     clients. We have adapted CBT for psychosis in Pakistan for use with local clients. Initial~     evaluations have found that these therapies are effective. Due to the financial restraints we~     would like to test a brief version of the Culturally adapted CBTp (CaCBTp) in Pakistan. We~     want to see if brief CaCBTp (6 sessions of CBT) would be effective in non western cultures in~     educing symptoms of schizophrenia. This study will test brief CaCBTp against care as usual in~     Pakistan in secondary care.~   "
129218|NCT01876043|"~     Liposarcomas are soft tissue sarcomas most frequent. We distinguish three subtypes on the~     basis of their histological and cytogenetic characteristics: well-differentiated liposarcoma~     / dedifferentiated, myxoid liposarcoma and / or round cell liposarcoma and pleomorphic.~     Dedifferentiated liposarcomas (LDD) represent 20% of liposarcomas and are characterized by~     well-differentiated component associated with a contingent sarcomatous differentiation and~     fat-usually high grade. The LDD are most often rétropértionéal seat. Thus, their development~     is very long asymptomatic. At diagnosis, tumor volume is often very important making surgical~     removal impossible in a high proportion of cases. Operable tumors have also a risk of local~     recurrence by about 50% and about 20% metastatic. Chemotherapy is the only treatment of these~     advanced forms. However, the currently available drugs (adriamycin, ifosfamide) have only~     very limited effectiveness. Progression-free survival of patients does not exceed 2 months.~     The LDD is characterized cytogenetically by the constant presence of two amplicons (1p32 and~     6q23) respectively targeting genes MAP3K5 and JUN. These two genes encode proteins involved~     in the signaling pathway Jun N-terminal kinase (JNK). Activation of JNK is involved in the~     loss of adipose differentiation and tumor aggressiveness of LDD. The plitidepsin is a drug~     capable of inducing apoptosis of tumor cells carrying a functional activation of the JNK~     pathway. This drug has such a pro-apoptotic and anti-proliferative in vitro models of LDD.~     plitidepsin could represent the treatment of choice for patients with advanced LDD. The~     objective of this study is to evaluate the anti-tumor activity of plitidepsin patients with~     locally advanced dedifferentiated liposarcomas and / or metastatic.~   "
129219|NCT01876030|"~     The investigators hypothesize that the gait pattern of following the utilization of a~     functional electrical stimulation device will be much improved when compared to the effect of~     regular gait re-education with ankle-foot-orthosis (AFO) fitting in patients in early stages~     following stroke.~   "
129220|NCT01876017|"~     This Study is single arm, single center trial to check the safety and efficacy of Autologous~     Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs)for the patient with CRF~   "
129221|NCT01876004|"~     Objectives: To evaluate if, when considering expectant management in tubal ectopic pregnancy~     if the complementary use of Methotrexate could provide better results. We evaluate the~     success of treatment and the time required for titers of β-hCG to become negative. Methods: A~     double-blind randomized study, held at the Department of Obstetrics UNIFESP. The patients~     will be divided into two groups: in one patients will be administered a single intramuscular~     dose of 50 mg/m2 of Methotrexate and in the other patients will be prescribed Placebo~     intramuscularly. The monitoring will be done by measurement of β-hCG in the 4th and 7th day.~     When the decline of beta-hCG titers was > 15% in this interval, the patient was followed with~     weekly dosing of β-hCG until the titers become negative. The criterion of success is when the~     β-hCG was negative. The treatment failure occurs when surgery was necessary.~   "
129222|NCT01875991|"~     The study will estimate the preference of rheumatoid arthritis (RA) and Plaque Psoriasis~     (PsO) patients who self inject etanercept for one of two experimental autoinjectors.~   "
129223|NCT01875978|"~     Phytosterols are plant sterols . Phytosterols have anti-inflammation effect. Investigators~     have a hypothesis: phytosterols reduce oxidative stress , enhance Insulin-like growth~     factor-1(IGF-1) and endothelial progenitor cells(EPCs). Therefore, phytosterols has novel~     role in cardiovascular protection.~   "
129238|NCT01875783|"~     The purpose of this protocol is to determine whether point of care optical coherence~     tomography (OCT) imaging combined with an OCT-guided retinal referral algorithm at primary~     diabetes care visits increases rates of retina specialist eye care for patients with diabetic~     macular edema. The hypothesis is that OCT imaging with an automated OCT-guided referral~     algorithm will enable identification of patients at risk for vision loss from diabetic~     macular edema and facilitate direct referral to retina specialists for more timely evaluation~     and treatment.~   "
129224|NCT01875965|"~     Background and Purposes: Orthognathic surgery is necessary in more than 25% of patients with~     cleft lip and palate (CLP) to correct skeletal discrepancy and to obtain harmonious facial~     esthetics in the final phase treatment. A setback of mandible by bilateral sagittal split~     osteotomy (BSSO) along with maxillary osteotomy is usually performed when large skeletal~     discrepancies or associated mandibular deformities (e.g., asymmetries, canting of the~     mandibular occlusal plane) are present. Although the surgical technique of BSSO is~     well-developed, the neurosensory disturbances of the inferior alveolar nerve (IAN) remain one~     of the major postoperative complications. The purpose of this study is to identify the risk~     factors of IAN disturbances after BSSO and in turn to help clinicians to avoid such~     complication and to raise the satisfaction level of patients.~      Design: Prospective prognosis study. Setting: Chang Gung Craniofacial Center, Taoyuan.~     Patients: Two hundred Taiwanese patients with nonsyndromic CLP (age, >16 for females, >18 for~     males), who will undergo a BSSO as a part of the correction of their dentofacial deformities~     Measurements: All patients will undergo subjective (e.g., questionnaire) and objective (e.g.,~     2-point discrimination, light touch detection, and sharp/blunt detection) neurosensory~     assessments before surgery, and 1, 3, 6, 12 and 24 months after surgery. Cone beam computed~     tomography is performed before surgery and 1 week after surgery. Peri-operative factors~     including type of BSSO, extent of surgical correction, extent of split and fixation screws,~     concomitant genioplasty or third molar extraction are assessed. Patient-related factors~     including age, gender, bone quality of inferior alveolar canal are recorded as well.~      Data Analysis: Univariate and multivariate analyses will be performed. Statistical~     significance is assumed for a p value of less than 0.05.~   "
129225|NCT01875952|"~     The purpose of this study is to determine of once identified to the subjects infected with~     human immunodeficiency virus (positive VIH), to diagnose latent Tuberculosis, and to treat~     her with isoniazid for six months, measuring the production of Interferon range pre and~     posttreatment, to evaluate this way the result of the treatment on the immune response~   "
129226|NCT01875939|"~     This study is aimed to ascertain the effect of food on pharmacokinetics of WCK 2349 and~     determine the absolute bioavailability of WCK 2349 1000 mg (oral, QD dose) with respect to~     WCK 771 800 mg (intravenous, QD dose).~      This study would ascertain/confirm the therapeutically equivalent oral and IV doses of WCK~     2349 and WCK 771 respectively, and provide guidance in case of switch over therapy (WCK 771,~     IV to WCK 2349, oral) in future clinical trials in patients.~   "
129227|NCT01875926|"~     The overall aims of the study are:~        -  To provide additional information on the pharmacokinetics of ALX-0171 by measuring (i)~          local (bronchoalveolar lavage fluid (BALF)) and systemic (plasma) concentrations of~          ALX-0171 after oral inhalation, and (ii) systemic (plasma) and urine concentrations~          after intravenous administration.~        -  To further determine the safety and local and systemic tolerability of ALX-0171.~        -  To further evaluate local (induced sputum) and/or systemic (serum) immunogenicity of~          ALX-0171, by analysing the potential occurrence of anti-drug antibodies (ADA).~   "
129228|NCT01875913|"~     The investigators will work with one of Vitality's partner corporations to test whether~     curiosity can motivate employees to follow through on their virtuous intentions and complete~     their annual health risk assessment (VHR). Employees will receive email messages that contain~     either a curiosity-inducing question or a standard encouragement message. The investigators~     predict that presenting people with curiosity-arousing questions will make them more likely~     to complete a health risk assessment, as compared to standard messages.~   "
129229|NCT01875900|"~     Simulation-based training has been widely implemented in medical education. According to~     educational theories, simulation-based medical education (SBME) is associated with~     significant advantages, which has been investigated and proved by many studies. However, the~     value of SBME in comparison to other instructional methodologies remains largely unknown.~     Therefore, the aim of this study is to directly compare two instructional methods for~     neonatal resuscitation training.~   "
129230|NCT01875887|"~     Combined application of surgery planning software and rapid prototyping technology and~     preshaped titanium plates can effectively promote the accuracy of the diagnosis and treatment~     of bilateral maxillofacial post traumatic deformities, reduce operation time and improve~     surgical effect.~   "
129231|NCT01875874|"~     This phase 2 study is developed to evaluate the effect of ELAD on overall survival (OS) in~     subjects with acute liver failure (ALF) compared to matched historical controls.~   "
129232|NCT01875861|"~     The purpose of this study is to test an approach for implementing guideline recommendations~     for assessing and managing metabolic side effects (including weight gain, diabetes, elevated~     lipids) in patients prescribed antipsychotic medications.~   "
129233|NCT01875848|"~     This study compares buprenorphine/naloxone to opioid dose escalation among patients with~     poorly controlled non-cancer pain on 30-100 mg daily morphine equivalent opioid dose.~   "
129234|NCT01875835|"~     Primary percutaneous coronary intervention (PCI) represents the preferred reperfusion~     strategy for patients with ST-segment elevation myocardial infarction (STEMI), since it is~     more effective than thrombolytic regimens in reducing adverse events, including death.~     Drug-eluting stents (DES) are currently being widely used in patients with STEMI. The~     effectiveness of DES to reduce restenosis and the need for revascularization compared with~     bare-metal stents (BMS) has been documented in randomized controlled trials. The~     first-generation DESs implanted in STEMI have been associated with delayed healing and~     incomplete strut coverage. Therefore, in patients with implanted DES, longer duration of dual~     antiplatelet therapy is needed. The second-generation DESs (ZES and EES) have been improved~     the drug and polymer, which have been proved to improve neointima healing compared with the~     first generation DESs.~      However, the difference of strut coverage between EES and BMS implanted in STEMI patients is~     unknown. In this study, we assess the neointimal coverage at 3-month and 12-month follow-up~     in EES and BMS implanted in patients with STEMI by optical coherence tomography.~   "
129235|NCT01875822|"~     Current evidence suggests that schizophrenia as a serious and complex psychiatric disorder,~     continues to challenge mental health professionals in their search for better treatment~     options in the community. In the present study, the investigators hypothesized that in~     patients diagnosed as schizophrenia, adjunct treatment with Curry extract from the plant~     labeled by botanists as Curcuma Longata, formulated as Super-Curcumin@ , would bring about~     :1)positive behavioral changes in areas of socialization, emotional well-being, verbal~     communication and motivation; 2)improvement in measures of memory. Throughout the study, the~     proprietary product, Super-Curcumin@ consisting of Curcumin C-3 complex combined with the~     black pepper extract Bioperine to boost the effects of Curcumin. The study was developed to~     examine whether Curcumin's interaction with the two major signal pathways in the brain~     regulating brain-behavior: the epigenetic signal (histone modification) and the~     anti-inflammatory signal (inducible nitric oxide synthetase)in preclinical models is~     translated to beneficial effects in the treatment of schizophrenia.~   "
129240|NCT01875757|"~     A phase III multicenter randomized double blind clinical trial will be conducted. After~     obtaining written consent the infant will be randomized, during the first two weeks of life,~     to a study group to receive either 400 IU or 1,000 IU / day of vitamin D to the year of age.~      Baseline and all follow up visits (2, 6, and 12 months of life) will include anthropometric~     measurements and a questionnaire about health issues. A blood sample will be obtained at~     baseline for analysis of 25OH vitamin D, and at 6 and 12 months for analysis of 25 OH vitamin~     D, and calcium.~      Healthy term born infants of appropriate size for gestational age will be included. We will~     need to include 359 children in each group.~      The primary objective of the study is to decrease the proportion of infants with acute~     bronchitis during the first year of life by supplementation of 1,000 IU/day vitamin D.~     Secondary otcomes are: To check that the administration of 1,000 IU/day vitamin D decreases~     the proportion of infants with upper respiratory tract infections, the proportion of children~     under one year of age hospitalized for acute bronchiolitis, and the demand on the healthcare~     system due to respiratory infections and absences from work for parents and achieves a higher~     proportion of children with adequate blood levels 25 OH vitamin D.~   "
129241|NCT01875744|"~     Background:~      Aim:~      Clinical evaluation of the effectiveness of two different polyethylene glycol doses for the~     maintenance treatment of functional constipation in children.~      Study design:~      Randomized, open-label trial.~      Randomized, double-blind, placebo controlled trial.~   "
129242|NCT01875731|"~     The aim of this study is to test if BPS (Bacterial Pneumonia Score) guided antibiotic use in~     children with non severe community acquired pneumonia (CAP) and pneumoccocal vaccine will~     reduce antibiotic use as compared to standard care practice (current guidelines for CAP).~   "
129243|NCT01875718|"~     The study is a phase 1/2 study in two parts. In part 1, the primary objective is to assess~     the pharmacokinetics of UC1010 when administered subcutaneously as a single dose to healthy~     women. The safety and tolerability of UC1010 is also evaluated in study part 1.~      In part 2, the primary objective is to assess the pharmacodynamic effect of UC1010 on~     premenstrual symptoms in women with Premenstrual Dysphoric Disorder (PMDD) when given during~     the luteal phase of the menstrual cycle. The pharmacodynamic effect is evaluated through the~     patients' daily ratings of premenstrual symptoms. In both study parts, two active treatment~     groups are compared to one placebo group.~   "
129244|NCT01875705|"~     This is an open-label, multicenter, dose-escalation study to assess the safety, tolerability,~     and pharmacokinetics of GDC-0994 in patients with locally advanced or metastatic solid~     tumors. Patients will be enrolled in one of two stages: a dose-escalation stage (Stage I) or~     the subsequent expansion stage (Stage II). Stage I will evaluate the safety, tolerability,~     and pharmacokinetics of increasing doses of GDC-0994 administered daily. Stage II will gather~     additional data on safety, tolerability, and pharmacokinetics of the recommended dose of~     GDC-0994 determined in Stage I.~   "
129245|NCT01875692|"~     Pathogens of ventilator-associated pneumonia (VAP) come from colonizers of the trachea. The~     hypothesis of the investigators is that during the first days of intubation, independently of~     the use of antibiotics, there is a change in the oro-pharyngeal flora leading to the~     selection of one pathogen in the trachea, that will finally be the cause of VAP.~      The investigators designed a prospective study including 300 patients intubated for more than~     3 days, with daily analysis of oro-pharyngeal juice and tracheal aspirate by culture and~     metagenomics, in order to determine if this microbiological surveillance permits:~        1. To predict a high risk to develop a VAP in the next 48h and even to predict its agent~        2. To better understand the development of VAP by studying the evolution of the~          respiratory flora in the context of intubation~   "
129246|NCT01875679|"~     Simulation in surgical skills training is widely accepted as a necessary step to improve~     surgical training outside the operating room. Simulation predominately focuses on teaching a~     specific task or procedure. Once this task is acquired ongoing optimization of technique is~     desirable. Commonly ongoing skills assessment occurs in the form of peer feedback throughout~     training rotations. This feedback is frequently subjective and of variable educational use.~     Identifying ongoing technical training needs and enabling personalized objective feedback~     represents an important training concept that has not yet been formally used in resident~     training.~      The specific goal of this study is to prove the effect of a comprehensive surgical coaching~     (CSC) approach which combines concepts of behavior modeling training, task debriefing and~     error recognition to improve overall surgical technique without additional technical skills~     training.~   "
129247|NCT01875666|"~     Kinases are a group of proteins that are important in how cancer cells grow. HER2 is a kind~     of kinase. This study looks at a new approach to identifying kinases, which may help target~     therapy more precisely.~      LCCC1214 is a randomized, multiarm, multicenter, open-label window trial designed to explore~     the kinome response in Stage I-IV HER2 positive (HER2+) breast cancer patients scheduled to~     undergo definitive surgery (either lumpectomy, mastectomy or surgical resection of~     oligometastatic disease). Patients will initiate dosing with either a single HER2-directed~     agent or a combination of two HER2-directed agents, one week prior to surgery. Forty patients~     will be randomized to one of four study groups:~      A) single dose trastuzumab; B) single dose pertuzumab; C) combination single dose trastuzumab~     plus single dose pertuzumab; or D) combination single dose trastuzumab plus lapatinib daily~     for 7 days.~      Pre- and post- dosing tissue will be analyzed for kinome response and resistant signatures.~     The initiation of study drug will be defined by the surgical schedule; there will be no~     delays in standard treatment for the purposes of this study.~   "
129259|NCT01875510|"~     Docosahexaenoic acid (DHA) has been shown to be particularly important for fetal and neonatal~     development. Infants born prematurely are at special risk for DHA insufficiency. The source~     of DHA after birth for preterm babies who are not fed full enterally, are mostly fat~     emulsions as the component of total parenteral nutrition solutions which usually do not~     contain DHA. The aim of this study is to investigate if the fish oil emulsion-administered~     from the first day of life and during parenteral nutrition-prevents infants from cholestasis~     and retinopathy of prematurity.~   "
129341|NCT01874405|"~     Iron overload is a leading cause of morbidity and mortality in transfusion-dependent~     patients. Deferasirox is the most promising iron chelator agent in several clinical~     scenarios. The investigators propose a retrospective study (chart review) to evaluate~     comprehensive iron overload management in transfusion-dependent patients treated with~     deferasirox for up to 5-10 years in a real clinical practice setting.~   "
129248|NCT01875653|"~     The purpose of this research is to evaluate the safety and effectiveness of tumor cell~     therapy.~      This research study is evaluating if a patient-specific experimental therapy for metastatic~     melanoma will lengthen survival with minimal harmful effects. It is called an experimental~     therapy (or study therapy) because it is not yet approved by the U.S. Food and Drug~     Administration (FDA). This research study will use the patient's own tumor cells,the~     patient's own dendritic cells (a type of immune cell), and a granulocyte-macrophage colony~     stimulating factor (GM-CSF, a type of growth factor). GM-CSF is a natural growth factor that~     stimulates growth of white blood cells in the body. Since 1991, GM-CSF has been used as a~     standard treatment to help increase the number of white blood cells after chemotherapy.~      The patient's dendritic cells are grown in a test-tube with the patient's tumor cells and the~     growth factor. The resulting solution is called the study therapy. The intent of the study~     therapy is to make the dendritic cells more effective at fighting the tumor when they are~     injected back into the patient.~   "
129249|NCT01875640|"~     The birth of a child with a disorder of sex development (DSD) is stressful for parents and~     members of the healthcare team. The right decisions about gender assignment (is it a boy? a~     girl?) and the best course of action (e.g., should there be surgery? what kind? when?) are~     not obvious. While there have been large advances in diagnostic assessments like genetic and~     endocrine testing, the tests do not always show what caused the DSD. And, even when the tests~     do reveal an explanation for the DSD, knowing what happened genetically or hormonally does~     not usually lead to a single correct treatment plan. Instead, it is likely that there are~     different acceptable treatment options - and parents will need to make decisions based, in~     part, on their personal preferences, values, and cultural background. Adding more stress to~     the situation is knowledge that many of the decisions that need to be made by parents early~     in a child's life are irreversible and exert life-long consequences for the child and the~     family.~      To support parents becoming actively involved in making such decisions, and to reduce the~     likelihood of future worry and regret about decisions that have been made, the investigators~     will create a decision support tool (DST). The DST will help educate families about typical~     and atypical sex development of the body, the process by which DSD are diagnosed (especially~     how to interpret genetic test results), and possible relationships between diagnostic/genetic~     testing, decisions about care, and known consequences of those decisions on their child and~     entire family. The DST will be used by parents of young children together with their child's~     health care provider.~      The investigators will bring together a network of researchers, health care providers,~     representatives of patient support and advocacy organizations, and parents of children with~     DSD to share their experiences. Participants of this network will be involved at each stage~     of creating the DST, revising it, and putting it into practice. At the end of this project,~     the investigators will have a fully formed DST that will be available for parents to use with~     their child's healthcare team as they are first learning their child may have a DSD.~   "
129250|NCT01875627|"~     To evaluate the effects of Konjac on satiety and subsequent food intake in healthy~     individuals.~   "
129251|NCT01875614|"~     Use of dipole density mapping to identify activation in complex supraventricular tachycardias~   "
129252|NCT01875601|"~     BACKGROUND:~        -  Despite progress, some children and young adults with solid tumors still experience poor~          survival.~        -  Activated NK cells potently kill autologous pediatric solid tumors, and clinical grade~          procedures are available to generate large numbers of activated NK cells for adoptive~          cell therapy.~      OBJECTIVES:~        -  Primary objectives are: 1) to assess the feasibility of harvesting and expanding~          activated NK cells to meet escalating dose goals in Cohort A, 2) to assess the toxicity~          of infusing escalating doses of activated NK cells following lymphodepleting~          chemotherapy without rhIL15 (cohort A), and 3) to assess the toxicity of infusing NK~          activated cells with escalating doses of rhIL15 (cohort B) in pediatric patients with~          refractory malignant solid tumors.~        -  Secondary objectives are: 1) to identify biologically active doses of activated~          autologous NK cells plus or minus rhIL15 by monitoring changes in NK cell number,~          phenotype and function, 2) to assess pharmacokinetics and immunogenicity of rhIL15 in a~          pediatric population, and 3) assess antitumor effects and changes in FDG-PET following~          administration of activated NK cells to lymphopenic hosts plus or minus rhIL15. 4) to~          evaluate saftey and efficacy of subsequent cycles of autologous NK cell infusions in~          patients in cohort A who received benefit from the first NK cell infusion.~      ELIGIBILITY:~        -  Patients in Cohort A: 2-29 years with with refractory pediatric malignant solid tumors,~          Patients in Cohort B: 2-25 years with refractory pediatric malignant solid tumors.~        -  Adequate performance status and organ function, recovered from toxic effects of prior~          therapy, no requirement for systemic corticosteroids and no history of allogeneic stem~          cell transplantation.~      DESIGN:~        -  All patients receive pre-NK lymphodepleting chemotherapy with cyclophosphamide.~        -  Cohort A receives escalating doses of activated autologous NK cells to identify~          feasibility of generating cells and tolerability, and potentially identify an MTD.~        -  A1: 1x10(6) NK cells/kg~        -  A2: 1 x 10(7) NK cells/kg~        -  A3: 1 x 10(8) NK cells/kg~        -  If feasibility and acceptable toxicity is demonstrated for all doses in Cohort A,~          patients enrolled on cohort B will receive activated autologous NK cells plus escalating~          doses of rhIL15 using the following schema:~        -  B1: 1 x 10(7) NK cells/kg + rhIL15 0.25 mcg/kg/d IV x 10~        -  B2: 1 x 10(7) NK cells/kg + rhIL15 0.25 mcg/kg/d IV x 10~        -  B3: 1 x 10(7) NK cells/kg + rhIL15 0.5 mcg/kg/d IV x 10~        -  B4: 1 x 10(7) NK cells/kg + rhIL15 0.75 mcg/kg/d IV x 10~        -  Three patients will be enrolled at each dose level, with the dose level expanded to 6 if~          dose-limiting toxicity occurs. An expanded group of 12 patients will be treated at the~          highest tolerable dose level. DLT toxicity monitoring will continue for 21 days after~          the NK infusion, or 14 days after the last rhIL15 dose in Cohort B (whichever is later).~   "
129253|NCT01875588|"~     Background:~      - People with human immunodeficiency virus (HIV) can sometimes develop thinking and memory~     problems. These problems can vary widely, from few symptoms to severe problems with memory~     and concentration. It initially was thought that good HIV treatment could prevent almost all~     HIV-related memory problems. However, even people with low HIV viral loads can have these~     problems. It may be caused by HIV affecting the brain and spinal fluid. It is not yet clear~     why HIV causes these problems and why they may be worse in some people than others.~     Researchers want to study people with HIV and healthy volunteers to see how HIV may affect~     people with only small amounts of the virus in their blood.~      Objectives:~      - To study thinking and memory problems in individuals with HIV that is otherwise controlled~     with medications.~      Eligibility:~        -  Individuals between 18 and 61 years of age whose HIV has been controlled with~          medications for at least 1 year.~        -  Healthy volunteers between 18 and 61 years of age.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. A neurological test will also be given. Participants will~          have a baseline imaging study of the brain.~        -  Within 12 weeks of the first visit, participants will have a second visit. Additional~          blood samples will be drawn. Another brain imaging study will be performed.~        -  Within 8 weeks of the second visit, participants will have a third visit to collect more~          blood samples. They will also provide spinal fluid samples, either as a single visit or~          a longer procedure.~        -  After this visit, participants will return every 6 months for up to 5 years. Blood~          samples will be collected as needed at these visits. Thinking and memory tests and~          imaging studies may also be given as needed. Spinal fluid may be collected at one visit~          a year.~   "
129254|NCT01875575|"~     The objective of this study is to examine gastric emptying and satiety hormones after oral~     glucose stimulation in 2 different concentrations in normal-weight and obese patients.~   "
129255|NCT01875562|"~     Neck pain is a common symptom in most patients suffering from cervical radiculopathy.~     However, some conservative treatments are limited by their modest effectiveness. On the other~     hand, surgical intervention for cervical disc disorders is indicated when symptoms are~     refractory to conservative treatments and neurological symptoms are progressive. Many~     patients use complementary and alternative medicine, including Traditional Chinese Medicine,~     to address their symptoms. The purpose of the present study is to examine effectiveness and~     safety of Qishe Pill, a compound traditional Chinese herbal medicine, for neck pain in~     patients with cervical radiculopathy.~   "
129256|NCT01875549|"~     Internal biliary drainage is an useful method for a control of jaundice and cholangitis to~     patients who had a malignant hilar obstruction due to hepatocellular carcinoma,~     cholangiocarcinoma, gall bladder cancer or metastatic lymphadenopathy.~      Bilateral biliary drainage is more physiologic but technically difficult to compared with~     unilateral biliary drainage specially related to conformability and flexibility between using~     stents.~      There are no prospective clinical trials compared with these internal biliary drainage~     methods in hilar malignant obstruction using metal stent.~      Therefore, the investigators want to compare the clinical outcome of two method: Unilateral~     biliary stent and Bilateral biliary stent~   "
129260|NCT01875497|"~     There is evidence that intense physical activity has a potential effect on thrombotic events~     due to catecholamine release. The hormones leptin and adiponectin have been used as markers~     of cardiovascular risk, but they are few and contradictory studies that relate physical~     training intensity and duration of high plasma concentrations of these hormones. The use of~     antioxidants, such as proanthocyanidins present in grapes, may help in reducing the~     undesirable effects of intense training.~   "
129261|NCT01875484|"~     Purpose: The purpose of this study is to evaluate the impact of circulating miR-126 on left~     ventricular remodeling and clinical outcomes in patients undergoing primary percutaneous~     coronary intervention for ST-segment elevation myocardial infarction.~   "
129262|NCT01875471|"~     The objective of this study is to compare the ease of removing two daily disposable soft~     contact lenses off the eye.~   "
129263|NCT01875458|"~     Bisphosphonates are drugs that prevent bone loss by blocking the activity of cells that~     normally resorb bone. The most common examples of these drugs are Boniva and Fosamax. These~     drugs are available for oral or intravenous dosing and are prescribed at daily, weekly,~     biweekly, or monthly intervals. Among the many thousands of individuals who currently take~     these medications, certain individuals experience atypical femur fractures preceded by~     prodromal pain, changes in cortical thickening of bone, or bisphosphonate related~     osteonecrosis of the jaws (BRONJ). Osteonecrosis of the jaws is defined as exposed bone of~     the jaws for 8 weeks or more and requires surgical treatment.~      This study will attempt to identify genomic and rna biomarkers that may play a role in~     differential metabolism of bisphosphonates or indicate tendency toward the severe adverse~     events associated with these drugs.~   "
129264|NCT01875445|"~     The purpose of this study is to evaluate the safety and effectiveness of inositol for the~     treatment of compulsive hair pulling, also known as trichotillomania. Inositol is used for~     diabetic nerve pain, panic disorder, high cholesterol, insomnia, cancer, depression,~     schizophrenia, Alzheimer's disease, attention deficit-hyperactivity disorder (ADHD), autism,~     promoting hair growth, a skin disorder called psoriasis, and treating side effects of medical~     treatment with some medications, including lithium. The hypothesis to be tested is that~     Inositol will be effective and well tolerated in patients with trichotillomania compared to~     placebo. The proposed study will provide needed data on the treatment of the disabling~     disorder that currently lacks a clearly effective treatment.~   "
129265|NCT01875419|"~     Depression is a serious mental health problem that affects millions. Depression is usually~     treated using drugs and/or psychotherapy, but neither approach is successful for everyone,~     and some people do not respond to either. Therefore it is crucial that we continue to seek~     new methods for treating depression, and develop enhancements to existing treatments. In~     recent years, trials have documented improvements in depressive symptoms using noninvasive~     brain stimulation techniques, such as transcranial direct current stimulation, or tDCS. Our~     aim in this research is to investigate the effects of brain stimulation combined with~     psychological therapy in depression, an area that remains largely unexplored. Specifically,~     stimulation of the dorsolateral prefrontal cortex (DLPFC), a brain region known to work~     inefficiently in depression, has been shown to result in an improvement of depressive~     symptoms, as well as in the patient's 'cognitive control' abilities. Because 'cognitive~     control' processes, such as concentrating and ignoring distracting thoughts, are engaged~     during psychological therapies for depression, we predict that DLPFC stimulation should~     improve how patients respond to psychological therapy. This study has considerable~     implications as it will potentially benefit a large number of patients for which current~     treatments are ineffective.~   "
129266|NCT01875406|"~     The purpose of this study is to determine the predictive value of a composite of 3 simple~     clinically practical diagnostic tests (Mekhail's test, Patrick's and Thigh thrust) combined~     with a pain referral diagram in predicting response to a single diagnostic SIJ injection.~   "
129267|NCT01875393|"~     The aim of this study is to confirm the Efficacy,the Safety and the Quality of Life after~     TOOKAD® Soluble VTP in localized prostate cancer patients.~   "
129268|NCT01875380|"~     The purpose of this study is to assess the efficacy and safety of single-agent regorafenib in~     the first line treatment of frail and/or unfit for polychemotherapy patients with metastatic~     colorectal cancer (mCRC)~   "
129269|NCT01875367|"~     GEICAM/2012-07 is a study phase III, prospective, open, randomized, multicenter and national~     designed to assess patient preference for intravenous (IV) or subcutaneous (SC) of~     trastuzumab, and within the SC by the administration through the vial or device~     self-administration in patients with disseminated breast cancer HER2.~      Approximately 195 patients will be included to receive subcutaneous trastuzumab a fixed dose~     of 600 mg every 3 weeks for 4 cycles (2 administered from the injection of a vial with a~     syringe and 2 with the injection device). Following administration of these four cycles, the~     patient will decide whether or not to continue with the subcutaneous formulation of~     trastuzumab every 3 weeks until progression. Since the randomization in the study until the~     start with subcutaneous trastuzumab, patients will receive a treatment cycle of intravenous~     trastuzumab as usual.~      Main objective: Proportion of patients indicate a preference for the use of subcutaneous vs~     intravenous trastuzumab.~      This principal primary objective will be analyzed with the answers to questionnaire of~     experiences and preferences of the patients (Principal endpoint) The duration of the study~     has been estimated after 34 months.~   "
129270|NCT01875354|"~     The purpose of this study is to assess the safety and efficacy of a weight management program~     composed of dietary supplements and a reduced calorie eating program.~   "
129271|NCT01875341|"~     Hypertension is highly prevalent in type 2 diabetic patients (NIDDM) with nephropathy, and is~     the single most important determinant of the rate of renal function loss. In many of these~     patients, hypertension is resistant to therapy. Although increased sympathetic activity is~     also highly prevalent in NIDDM patients with nephropathy and chronic renal insufficiency,~     little attention has been paid to sleep apnea as the cause of both resistant hypertension and~     sympathetic hyperactivity in this population. Since the prevalence of sleep apnea is~     increased in patients with either NIDDM, or resistant hypertension, or chronic renal~     insufficiency, it is almost certain that sleep apnea has a high prevalence in patients in~     whom all three states co-exist, i.e. NIDDM patients with nephropathy and hypertension~     resistant to therapy. As a consequence of undetected and untreated sleep apnea, resistant~     hypertension, nocturnal hypertension, and sympathetic hyperactivity likely contribute to~     accelerated loss of renal function and increased cardiovascular morbidity and mortality in~     these patients.~      Hypothesis: A. Sleep apnea is highly prevalent in type 2 diabetic patients with diabetic~     nephropathy and hypertension resistant to therapy. Treatment with nasal continuous positive~     airway pressure (NCPAP) will result in a decrease in blood pressure and restore normal~     diurnal blood pressure pattern.~      B. Sleep apnea-caused hypertension is mediated by sympathetic hyperactivity and increased~     activity of the renin-angiotensin-aldosterone system (RAAS) in type 2 diabetic patients with~     nephropathy. A decrease in sympathetic hyperactivity in response to NCPAP therapy will result~     in a decrease in plasma renin activity and plasma aldosterone concomitant with decreases in~     blood pressure.~      Randomized, double blind, parallel comparative (two groups) one center trial.~      Therapeutic treatment with nasal continuous positive airway pressure (NCPAP) Sub-therapeutic~     treatment with nasal continuous positive airway pressure~   "
129272|NCT01875328|"~     This study aims to determine whether patients who have had a stroke caused by a blockage of~     blood flow to the brain can have medical follow up after they leave the hospital in their~     home using a camera connected to a computer, also called telemedicine. Patients who have~     follow-up with telemedicine will be compared with patients following up in the usual way, by~     coming to clinic, and will have the same expectations for medical care and lifestyle changes~     like quitting smoking, exercising, and controlling their cholesterol. The study will try to~     show those stroke patients who live 75 miles or more from Oregon Health & Science University~     (OHSU) and use a computer for follow up: 1) Will be able to complete the recommended visits~     using telemedicine in the home as well as those who come to clinic; 2) Will have blood~     pressures controlled at one year's time as well as those who follow up in the usual way by~     coming into clinic; 3) The patients followed with telemedicine will be as satisfied with the~     type of follow up they had as those followed in the usual way in the clinic. In the future,~     more patients who live at a distance from a major hospital might be able to get quality~     stroke care follow up using telemedicine if the study finds that telemedicine does meet these~     goals.~   "
129273|NCT01875315|"~     The primary objective of this project is to demonstrate that a new approach to cardiac stress~     imaging that combines treadmill exercise with cardiac magnetic resonance (CMR) provides~     valuable clinical information in a cost-effective manner.~   "
129274|NCT01875302|"~     This protocol defines the requirements to demonstrate that the PRO instruments which were~     designed as paper-based are equivalent to the nSpire Health ePRO (electronic patient reported~     outcome), following the ISPOR's ePRO Good Research Practices Task Force recommendations. All~     validation studies of the questionnaires were conducted using the original paper versions.~   "
129275|NCT01875289|"~     Efficacy of a modified obturator nerve block technique by using only a single morphological~     landmark, a double-blinded randomised pilot study.~   "
129276|NCT01875276|"~     The proposed study will evaluate the unmet therapy need in seasonal rhinitis by aiming to~     answer the following research questions~        1. What is the first prescription of the hay-fever season and how many of these patients~          are on some form of combination therapy?~        2. To what extent does initial therapy not meet clinical need (as measured by need for~          additional medical intervention in terms of consultations and changes in therapy)?~        3. Does treatment for allergic rhinitis differ for asthma Vs non-asthma and seasonal Vs~          perennial patients?~   "
129277|NCT01875263|"~     Evaluate the efficacy of a sequential regimen of 14 days in patients with catheter-related~     bacteremia by S. aureus methicillin-susceptible, selected based on a pre-established clinical~     and microbiological criteria.~   "
129278|NCT01875250|"~     Background:~      - Enzalutamide is a well tolerated hormone therapy that is used to treat advanced prostate~     cancer. It is given to help kill cancer cells and limit cancer cell growth. A new possible~     way of treating prostate cancer is using a therapeutic cancer vaccine (immune stimulating~     therapy) that may help activate the immune system against the cancer. The immune stimulating~     vaccine will help white blood cells recognize and kill the cancer cells throughout the body.~     This vaccine therapy has been tested in hundreds of patients and is very well tolerated.~     Researchers want to see whether this vaccine, given with enzalutamide, is more effective at~     treating advanced prostate cancer than enzalutamide alone.~      Objectives:~      - To compare the safety and effectiveness of enzalutamide with and without vaccine therapy~     for advanced prostate cancer.~      Key Eligibility:~        -  Men at least 18 years of age who have advanced castration sensitive prostate cancer.~        -  Patients must have testosterone within the normal range~        -  No evidence of metastatic prostate cancer on CT or Bone scan~        -  No history of autoimmune diseases~        -  No previous immunotherpy within 3 years~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Imaging studies will be used to monitor the cancer before~          treatment.~        -  Participants will be separated into two groups. One group will have enzalutamide and the~          study vaccine. The other group will have enzalutamide alone.~        -  All participants will take enzalutamide once a day. They will take the drug for 3~          months. This form of intermittent therapy is common in this population of patients.~        -  The vaccine group of participants will receive the new study vaccine. They will have a~          single injection on the first day of the first study cycle. There will be regular~          booster injections afterward. There will be one injection during the third week of~          treatment, and one in the fifth week. The vaccine will then be given every 4 weeks until~          21 weeks have passed.~        -  Treatment will be monitored with frequent blood tests and imaging studies.~   "
129279|NCT01875237|"~     The goal of this clinical research study is to learn if giving genetically changed immune~     cells, called T-cells, after chemotherapy will improve the response to a stem cell~     transplant. The safety of this treatment will also be studied.~      The process of changing the DNA (the genetic material in cells) of these T-cells is called~     gene transfer. Researchers want to learn if these genetically-changed T-cells are effective~     in attacking cancer cells in patients with leukemia, MDS, lymphoma, Hodgkin disease, or MM,~     after they have received an allogeneic stem cell transplant.~      The chemotherapy you will be given on study is fludarabine, melphalan, and alemtuzumab. These~     drugs are designed to stop the growth of cancer cells, which may cause the cancer cells to~     die. This chemotherapy is also designed to block your body's ability to reject the donor's~     stem cells.~      Researchers also want to learn if giving AP1903 will help the symptoms of graft-versus-host~     disease (GvHD) that may occur after the T-cell infusion. GvHD occurs when donor cells attack~     the cells of the person receiving the stem cell transplant.~   "
129280|NCT01875224|"~     This study is being conducted to determine if belatacept is an appropriate alternative~     immunosuppressive medication (reducing the immune system's effect) when a kidney transplant~     patient develops new onset diabetes after transplant (NODAT). Patients who are diagnosed with~     NODAT will be approached with the opportunity to participate in this study. If they agree to~     participate, they will be randomized one-to-one (like a coin flip) to the study arm~     (belatacept) or the control arm (their current medication regimen). If a patient is~     randomized to the study arm, they will be tapered off of their current regimen when they have~     started receiving their monthly belatacept infusions. The control arm will mean the patient~     will continue their current, standard of care medications, but following the tacrolimus~     trough levels indicated within the study protocol. Different laboratory tests (i.e. fasting~     blood glucose) will be measured during the study to monitor the progression of NODAT in all~     patients.~   "
129281|NCT01875198|"~     When distal pancreatectomy is carried out for left-sided pancreatic cancer, splenectomy is~     usually performed not only for margin-negative resection but also for effective clearance of~     the splenic hilar lymph nodes. However, there was no scientific evidence regarding the~     justifiability for spleen resection. Considering potential immunological function of the~     spleen, the investigators hypothesized that distal pancreatectomy without pancreatectomy for~     left-sided pancreatic cancer is superior than Distal pancreatectomy with pancreatectomy in~     terms of short-term perioperative outcomes and disease-specific overall survival.~   "
129282|NCT01875185|"~     The investigators are attempting to determine if the response to aspirin in women is related~     to the level of estrogen and progesterone that a woman has.~   "
129285|NCT01875146|"~     Investigation of the training effects following 8 weeks of high-intensity interval training~     (HIT)in combination with side-alternating whole-body vibration compared to conventional HIT~     or side-alternating whole-body vibration. The adaptations are investigated on a molecular~     (muscle biopsy of the M. vastus lateralis) and systemic (e.g. cycling, jumping mechanography,~     dynamometry) level. In addition, the acute effects of the first and last training session~     will be investigated on a molecular (e.g. satellite cell activation, mRNA abundance) and~     systemic (e.g. ventilatory ga exchange, heart rate, rating of perceived exertion) level.~   "
129286|NCT01875133|"~     The purpose of this study is to investigate the effect of a stay at moderate altitude on~     exercise performance of patients with chronic obstructive lung disease.~   "
129287|NCT01875120|"~     This prospective observational study aims to evaluate the influence of somatic symptom load~     and anxiety sensitivity as risk factors for the occurrence of postoperative nausea and~     vomiting (PONV). Physiological and psychological variables are assessed in female patients~     with an increased risk for PONV prior to a planned surgical intervention with a 33-item~     questionnaire composed of the ASI-3 and the PHQ-15. Postoperative evaluation includes the~     occurrence of nausea and vomiting in the first 24 hours after surgery. It is hypothesized~     that patients with high sum scores for somatic symptom load (measured with the Patient Health~     Questionnaire, PHQ-15) and with increased levels for anxiety sensitivity (measured with the~     Anxiety Sensitivity Index, ASI-3) experience more frequently postoperative nausea and~     vomiting (PONV) than patients with low scores in both self-rating instruments.~   "
129288|NCT01875107|"~     Our objective is to assess whether pre-treatment with a fixed dose of insulin, based on~     weight, given to pregnant patients with gestational or preexisting diabetes receiving~     betamethasone can provide adequate glycemic control.~      Our hypothesis is that pre-treatment with a weight-based calculated insulin dose will help~     maintain euglycemia for pregnant patients with gestational and preexisting diabetes after~     steroid administration, and possibly impact length of hospital admission.~   "
129289|NCT01875094|"~     This is a feasibility study of using health-IT to promote self-management of risk factors in~     stroke survivors.~   "
129290|NCT01875081|"~     If the participant voluntarily agrees to participate in the clinical trial before~     registration, the investigator conducts a screening test to evaluate the participant's~     suitability.~      A participant that satisfies all selection and exclusion criteria is assigned randomly to a~     test group (1-time or 2-time injection group) or control group (no-cell therapy group).~     Participants assigned to the 1-time injection group conduct cell therapy within 1 month after~     bone marrow aspiration. Before implementing cell therapy, implement hepatic artery~     catheterization which inserts a catheter into the hepatic artery through the right aorta~     femoralis and inject 5X107 autologous bone marrow-derived mesenchymal stem cells.~     Participants assigned to the 2-time injection group store 1-time injection amount of~     mesenchymal stem cells while being cultivated after sampled from the bone marrow, and will~     re-inject autologous mesenchymal stem cells within 1 month after first injection.~      Participants will make a total of 8 hospital visits on a 4-week interval after registration,~     and effectiveness and safety will be evaluated based on a fixed procedure on every visit.~   "
129291|NCT01875068|"~     The investigators have previously demonstrated utilizing a validated tool, that the quality~     of referrals from nurse practitioners (NP) and physician assistants (PA) is less than~     referrals from physicians. The investigators hypothesize that with local physician input, the~     quality of referrals from nurse practitioners and physician assistants will improve. This is~     a prospective study comparing patient referrals from nurse practitioners and physician~     assistants with and without prior discussion with a local physician.~   "
129292|NCT01875055|"~     STUDY OBJECTIVES: The main objective of this study is to determine the feasibility of~     implementing measures in the ICU, based on a physiological algorithm, to reverse decreases in~     cerebral oxygen saturation using, near infrared-reflected spectroscopy (NIRS).~      WHAT IS INVOLVED: Randomization of 50 patients is balanced by experimental group; control and~     intervention, with an allocation sequence based on a block size of ten, generated with a~     computer random number generator. In the INTERVENTION group ICU Staff will use NIRS to follow~     a physiologically guided strategy to maintain rSO2 within 90% of baseline values. In the~     CONTROL group ICU Staff will provide standard of care without the use of NIRS.~   "
129293|NCT01875042|"~     The proposed study is a multi-center, randomized, double blind (patient and assessor), sham~     controlled clinical trial using a parallel 2 group design recruiting 220 patients of at least~     18 years of age. The investigators will include patients presenting with clinically and~     radiologically diagnosed knee OA according to the criteria of the American College of~     Rheumatology, who experienced knee pain lasting for at least six months, and were diagnosed~     with radiographic severity of ≥ 2 on the Kellgren-Lawrence grading system or had one or more~     of the following signs and symptoms in the knee; restricted range of motion, pain in motion,~     crepitations, morning stiffness. Patients will be randomly allocated to receive TENS or sham~     TENS for 3 weeks.~   "
129294|NCT01875029|"~     Back School (BS) is a behavioural intervention designed to treat and prevent chronic low back~     pain. Up to date clinical research studies have shown that transcranial direct current~     stimulation (tDCS) is able to decrease the intensity and duration of pain modulating the~     activity of brain areas involved in the circuits that regulate pain and facilitating the~     mechanisms inhibitors descendants of pain control.~      The aim of this study is to test the feasibility of combining tDCS with a behavioural~     intervention (i.e. BS) in subjects with chronic low back pain.~   "
129295|NCT01875016|"~     The purpose of the study is to perform endocardial catheter CRyo-Ablation to relieve the LVOT~     obstruction in patients with Hypertrophic Obstructive Cardiomyopathy.~      The investigators hypothesize that the investigators will be able to reduce > 50% of the~     initial LVOT gradient. This will be considered as a successful procedure.~   "
129390|NCT01873755|"~     This proposal will address the existent gaps in the literature by identifying barriers and~     facilitators to participation in physical activity in inner-city minority elementary~     schoolchildren with asthma, more that half of whom are also overweight; developing and~     refining a school-based intervention in partnership with the community to improve physical~     activity; and conducting a pilot randomized controlled trial of the intervention to determine~     feasibility and obtain preliminary data for a future large-scale trial.~   "
129296|NCT01875003|"~     This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will~     evaluate the efficacy, safety, and tolerability of lebrikizumab in adolescent participants~     with asthma whose disease remains uncontrolled despite daily treatment with inhaled~     corticosteroids (ICS) therapy and at least one second controller medication. Participants~     will be randomized in a 1:1:1 ratio to receive double-blind treatment with either~     lebrikizumab ('High' or 'Low') or placebo, administered as subcutaneous (SC) every 4 weeks~     (Q4W) for 52 weeks, in addition to their standard-of-care therapy. This will be followed by~     an optional 52-week double-blind active-treatment extension. The anticipated time on study~     treatment is up to 104 weeks. Participants who complete the study to Week 104, discontinue~     prematurely or decide not to take part in the optional active-treatment extension will~     transition to the 20-week safety follow-up period.~   "
129297|NCT01874990|"~     Cardiovascular diseases are the principal cause of death in women in developed and developing~     countries and are importantly promoted by hypertension. Salt sensitivity of the blood~     pressure is considered as an important cardiovascular risk factor at any blood pressure~     level. Severe preeclampsia is a hypertensive disorder of the pregnancy that also arises as a~     risk factor for cardiovascular and renal diseases.~      The major aim of this study is to examine the salt sensitivity of the ambulatory blood~     pressure in women with a history of severe preeclampsia (< 34 weeks gestation) compared with~     women with no history of pregnancy-related hypertensive complications. We plan to recruit 20~     non-menopausal women with a history of severe preeclampsia, and 20 age, parity, race- matched~     premenopausal women as controls. The study has a case control randomized design. The salt~     sensitivity of the ambulatory blood pressure is defined as an increase of ≥4 mmHg in 24h~     ambulatory blood pressure on a high sodium diet. The high sodium diet is obtained by adding~     capsules of 6gr of NaCl/ day in the usual diet.~      The participants are identified as women discharged from the Maternity of University Hospital~     of Geneva between 1999 and 2001 with a preeclampsia coding. Fetal and maternal data will be~     carefully recovered from hospital records to identify severe preeclampsia (PE), based on~     International Society for the Study of Hypertension in Pregnancy criteria. These criteria are~     systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥110 mmHg with severe~     proteinuria (≥ 5g /24h or 3+ dipstick) and one or more signs of multisystem disease~     developing after 20 weeks of gestation in previously normotensive women. Severe preeclampsia~     was also defined as occurring before 34wk of gestation. Women with a history of hypertension,~     diabetes mellitus, renal or cardiac impairment, polycystic ovary syndrome will be excluded.~     Other exclusion criteria are anti-inflammatory drugs, diuretics, aspirin, oral contraceptives~     and hormonal replacement therapy. The protocol is approved by the University Hospital Ethical~     Committee and written informed consent will be obtained from each individual in accordance~     with the declaration of Helsinki. The study is conducted between 2009 and 2012 at the~     University Hospitals of Geneva, Switzerland.~   "
129298|NCT01874977|"~     The major goal of this project is to conduct a randomized, controlled trial of the impact of~     a practical, low cost physical activity intervention on fatigue among persons with rheumatoid~     arthritis (RA). Fatigue has been identified as a major concern for individuals with RA, and~     is considered a core outcome measure for RA. Our recent study of the sources of fatigue~     identified physical inactivity as a primary predictor of fatigue. Studies have examined the~     impact of exercise interventions on RA outcomes, but most of these interventions have focused~     on pain or function as outcomes. The few exercise studies examining fatigue suggest that~     increasing physical activity reduces fatigue, but the interventions have been~     resource-intensive, requiring specially trained personnel to administer them, highly~     structured activities, and/or attendance at classes or a specified facility. Each of these~     components increases the cost and barriers to implementation of an intervention. Pedometers~     have been shown to be an effective means of increasing physical activity, and could form the~     basis of a simple means to increase physical activity.~      This project will test the effect of a simple pedometer-based intervention, with two~     incremental degrees of guidance, on increasing physical activity and decreasing fatigue.~     Three groups (n=40 in each) will be studied: a control group with an educational pamphlet~     only, a pedometer-only intervention group, and a pedometer group with step targets. Both~     intervention groups will keep step-count diaries. Groups will be followed over 20 weeks. We~     expect that (1) the pedometer-only intervention group will increase activity more than the~     education group, and the group with step-count targets will demonstrate even greater~     increases in activity; and (2) greater increases in activity will be associated with greater~     decreases in fatigue. Secondary outcome measures will include depressive symptoms,~     self-reported sleep quality, and body composition. Our overall goal is to demonstrate an~     effective, yet simple and low cost, physical activity intervention to decrease fatigue that~     could be broadly accessible and have the potential for wide implementation.~   "
129299|NCT01874964|"~     Methadone maintenance treatment (MMT) has been shown to be effective in reducing drug use,~     criminal activity and recidivism. Given this effectiveness, maintaining individuals who are~     enrolled in community MMT when committed to the Department of Corrections for short term~     incarceration would improve post release outcomes. However, this is rarely practiced in the~     United States. Current practice at the Rhode Island Department of Corrections is to detox~     inmates on methadone within 30 days of being incarcerated. More than 75% of these individuals~     are incarcerated for less than six months. The period immediately after release from~     incarceration is a particularly high-risk time for HIV and other problems including drug~     relapse and overdose.~      The investigators hypothesize that inmates who are incarcerated for 6 months or less will~     have better outcomes and cost the state less money if they are maintained on their methadone~     dose and relinked to their community clinic at release, than the current practice of~     detoxification.~   "
129300|NCT01874951|"~     The purpose of this pilot study is to determine if taking a low dose of naltrexone in~     addition to an antidepressant medication can help treat relapse or recurrence in people with~     Major Depressive Disorder (MDD). The U.S. Food and Drug Administration (FDA) has approved~     naltrexone for the treatment of alcohol dependence and opioid dependence, but the FDA has not~     approved naltrexone to treat depression. The investigators hypothesize that patients with~     breakthrough depression on an antidepressant regimen containing a pro-dopaminergic agent~     assigned to treatment with low dose naltrexone will demonstrate higher rates of response~     compared to those patients taking placebo.~   "
129301|NCT01874938|"~     The main purpose of this study is to evaluate the effectiveness of LY2875358 in participants~     with MET diagnostic positive (+), advanced gastric or gastroesophageal junction (GEJ) cancer.~   "
129302|NCT01874912|"~     Irisin has been identified as a novel myokine that drives brown-fat-like conversion of white~     adipose tissue. In this cross-sectional study, the researches investigated whether serum~     irisin levels are decreased in patients with sarcopenia compared with control subjects with~     normal muscle mass, and assessed the association between serum irisin levels and various~     metabolic parameters.~   "
129303|NCT01874899|"~     The main purpose of this study is to establish the extent that chronic pain patients~     implanted with surgical, laminectomy-type, leads experience position-related variation in~     spinal cord stimulation therapy and to investigate the effects of manual versus automatic~     position-adaptive spinal cord stimulation on clinical outcome.~   "
129342|NCT01874392|"~     This clinical trial is a feasibility study to assess the performance of an Artificial~     Pancreas (AP) device using the Artificial Pancreas System (APS©) platform for subjects with~     type 1 diabetes using rapid-acting insulin as well as preprandial inhaled insulin~     (Technosphere® Insulin Inhalation System by MannKind Corporation). The goal of this proposed~     study is to explore the feasibility of using multiple insulin delivery routes in order to~     mimic the physiology of both first- and second-phase insulin secretion. The intent is to~     exploit the rapid action achieved by inhaled insulin to compensate for part of the meals and~     utilize the conventional subcutaneous route for management of basal insulin and as~     second-phase meal-related insulin.~   "
129304|NCT01874886|"~     Marijuana (Cannabis sativa) is the most widely used illicit drug worldwide, with 17.4 million~     Americans reporting past month use in 2010 and 4.6 million meeting criteria for dependence,~     underscoring the public health importance of understanding the biological implications of~     use. How heavy cannabis use affects brain structure and cognitive performance in late life is~     unknown. The ongoing maturation in the adolescent brain, including the developmental~     circuitry underlying memory performance and executive control puts the adolescent brain at~     high risk for detrimental effects of heavy cannabis use. With the aging of the 'baby boomer'~     generation, many people who used cannabis heavily as adolescents are now entering their~     senior years when age-related cognitive decline may begin. Cannabis use doubled in less than~     a decade during the 1970's when 38% of those surveyed in the U.S. Survey on Drug Abuse~     reported using cannabis and 12% of those users reported using cannabis more than 20 times a~     month. Understanding how heavy, early cannabis use may affect neurobiological and cognitive~     outcomes is of high importance for this aging population, which is already at risk for memory~     and cognitive deficits in aging. Because cannabis use appears to have a primary effect within~     the hippocampus, the main structure for memory and the structure affected most by age-related~     memory impairments and pre-clinical Alzheimer's disease, we expect that the effects of~     chronic cannabis use may be greatest during aging. To our knowledge, no study has~     investigated the long-term effects of adolescent cannabis use on hippocampal morphology and~     cognitive performance in an aging population.~      Investigators will investigate hippocampal integrity and cognitive performance using~     high-resolution magnetic resonance imaging (MRI), diffusion tensor imaging (DTI) and~     neuropsychological testing in an aging population of subjects (55-70 years old) who used~     cannabis more than 20 times a month for at least a year during adolescence. Investigators~     will compare data collected from heavy cannabis users to subjects who did not use cannabis~     but are matched for age, gender, education, light tobacco and light alcohol use. Finally,~     because family history and genetic risk are known to accelerate hippocampal morphology and~     memory decline in aging, the investigators will investigate whether possession of the APOE ε4~     variant in heavy cannabis users is synergistically related to thinner hippocampal cortex and~     white matter deficits.~   "
129305|NCT01874873|"~     Anlotibib (ALTN) is a kind of innovative medicines approved by State Food and Drug~     Administration（SFDA） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co.,~     Ltd. ALTN is a kinase inhibitor of receptor tyrosine with multi-targets, especially for~     VEGFR2 and VEGFR3. It has the obvious resistance to new angiogenesis. The trial is to explore~     ALTN for the effectiveness of advanced medullary thyroid carcinoma and security.~   "
129306|NCT01874860|"~     The purpose of this study is to determine if using preventive treatments such as Doxycycline~     (an anti-biotic) capsules, sunscreen with SPF 30, Hydrocortisone 1% cream and a moisturizer~     will help to reduce the incidence and severity of the skin rash associated with Cetuximab~     (Erbitux®) when compared to receiving standard care for the treatment of skin rash.~   "
129307|NCT01874847|"~     PURPOSE: The long-term goal of this line of research is to develop rational, biologically~     based evidence for the treatment of post-concussion syndrome (PCS) in children. The objective~     of this application is to examine the effect of melatonin on the symptoms of PCS and its~     neurobiology using integrated neurodiagnostic techniques in children.~      OVERVIEW: PCS is a constellation of clinical symptoms including physical (i.e. headaches),~     cognitive (i.e. memory), and behavioral disturbances. PCS is associated with significant~     morbidity in the child and his/her family), and yet there are no evidence-based medical~     treatments available. This suggests an urgent need to develop novel treatment options to~     improve outcomes for children suffering from PCS. Melatonin has several relevant mechanisms~     of action, and neuroprotective effects. Recent research suggests that the explanations for~     persistent PCS symptoms may be due to alterations in neurotransmissions and neuronal~     circuitry, particularly involving the dorsolateral prefrontal cortex (DLPFC). Investigators~     have two specific aims:~        1. To determine if treatment with melatonin improves PCS in children following mild~          traumatic brain injury. Hypothesis: treatment of mTBI children with PCS with 3mg or 10mg~          of oral melatonin for 28 days will result in a decrease in PCS symptoms as compared with~          placebo. Effects will be dose-dependent and may be independent of sleep effects.~          Methods: A randomized double blind, placebo controlled trial (RCT); Outcome measure is a~          PCS symptom questionnaire. A subsequent RCT will then be performed using the optimal~          melatonin dose at a second centre.~        2. To understand the neurophysiological mechanisms of paediatric PCS and assess any~          resultant effects of treatment with melatonin. Methods: A case-controlled study within~          the RCT, using functional MRI and Transcranial Magnetic Stimulation to investigate the~          neurophysiological properties of paediatric mTBI before and after treatment; Treatment~          groups from the RCT will be compared with two control groups: i) normal controls and ii)~          asymptomatic mTBI children.~      SIGNIFICANCE: This study has the potential to 1) provide a safe and effective treatment for~     PCS and 2) will provide valuable information about the neurophysiological properties of the~     brain associated with PCS following mTBI in children and how these change with symptom~     resolution.~   "
129308|NCT01874834|"~     The US EPA Clean Air Multiyear research program is moving toward a multi-pollutant approach~     to the assessment of air pollution in response to recommendations by the NRC 2004 and the~     BOSC in 2005. Such an approach better reflects the complexity of real-world air pollution~     problems and parallels evolving scientific and regulatory considerations. Ozone (O3) and~     diesel exhaust (DE) generally are major and important components of ambient air pollution.~     This proposed study will address the agency's goals by investigating the cardiopulmonary~     health effects in healthy human subjects co-exposed to O3 and DE. The findings derived from~     these exposures will provide NCEA findings for risk assessments of O3 and DE, as well as the~     Office of Air and Radiation (includes OTAQ and OAQPS) with information relevant to possible~     modulation of PM-induced health effects and responses by a gaseous co-pollutant for potential~     standard setting. Additionally the findings will address the fundamental driving principle of~     the Clean Air Research strategy related to reduction of health due to air pollutant~     exposures.~   "
129309|NCT01874821|"~     The purpose of this study is to examine the efficacy of dynamic splinting in reducing~     contracture following diagnosis of adhesive capsulitis.~   "
129310|NCT01874808|"~     This research program will focus on gait initiation and postural control in Amyotrophic~     Lateral Sclerosis (ALS) patients, by comparing patients with vs without postural instability~     (but also in comparison to controls), by using a multidisciplinary approach which combines~     neurophysiological and neuroimaging analyses.~      After clinical evaluation, two groups of ALS patients, defined upon the feature of postural~     instability, and one group of healthy subjects (n=25 for each group of patients and 20 for~     healthy subjects) will be included in the study.~      The neurophysiological evaluation will be performed through a gait initiation assessment,~     which will alow us to collect biomechanical and electromyographical data, such as the braking~     index.~      The neuroradiological evaluation will include first an fMRI analysis, a study of specific~     circuits in networks will be performed which will provide the first description of neural~     network dynamics associated with the preparation and execution of movement in ALS patients.~      The investigators major research hypothesis is:~        -  By comparing patients with vs without postural instability, but also in comparison to~          controls, the investigators main research neurophysiological hypothesis is that patients~          with postural instability will display an impaired braking.~        -  This impaired braking could be partly explained by a dysfunction and/or lesion of the~          basal ganglia and brain stem structures, corresponding to the investigators main~          neuroradiological hypothesis.~   "
129311|NCT01874795|"~     This study will evaluate the applications of ganglionar electrical stimulation in patients~     with Chagas Disease and Ischemic Heart Failure patients.~   "
130615|NCT01857687|"~     To assess the feasibility of CT-derived computed fractional flow reserve (FFRCT), wall shear~     stress and total plaque force on coronary atherosclerotic plaque and to collect the~     preliminary data to apply those parameters for the prediction of clinical outcomes in~     patients with coronary artery stenosis.~   "
129312|NCT01874782|"~     Individuals with acute cervical spinal cord injury (SCI) can suffer from an excessive and~     prolonged fall in blood pressure when assuming an upright position, such as transitioning~     from lying to sitting or standing, a condition also known as orthostatic hypotension (OH).~     Due to a decrease in cerebral oxygenation, affected individuals can develop debilitating~     symptoms including lightheadedness, blurred vision, fatigue and even loss of consciousness.~     Recent evidence suggests that OH has a negative impact on cognition in individuals with SCI.~     Clinical observations suggest that OH can lead to neurological deterioration in individuals~     who may otherwise have a stable SCI. The presence of symptomatic OH prevented participation~     in 43% of physical therapy treatment sessions in a study of individuals with acute SCI~     despite the use of current treatment options. OH is known to adversely affect health, delay~     rehabilitation and prolong hospitalization in the acute phase of management of individuals~     who display it. Our team found OH was present in 41 of 55 (75%) patients with acute cervical~     SCI at our center in 2004.~      We plan to research the efficacy of a low-cost, non-invasive device known as transcranial~     electrical stimulation (TES) to manage OH in individuals with acute cervical SCI. Previous~     studies have shown that this device is safe to use in individuals with SCI, and has improved~     blood pressure control in non-SCI individuals.~      We hypothesize that in individuals with acute cervical SCI and OH, TES intervention will~     elicit an attenuation of the drop in systolic BP (SBP)in response to orthostatic stress.~     TES-induced differences will be most pronounced in those individuals with sparing of spinal~     autonomic pathways~   "
129313|NCT01874769|"~     Recessive Dystrophic Epidermolysis Bullosa (RDEB) is one of the most severe rare inherited~     skin disorders affecting children and adults. Current medical care protocols for RDEB~     patients are limited to palliative procedures to treat blistering and erosive lesions,~     wounds, and severe local and systemic complications such as fusion and contracture of the~     digits, skin cancer, esophageal stricture, severe anemia, infections, malnutrition and growth~     retardation. However, current medical treatments still cannot prevent the recurrence of the~     lesions arising from defective expression of type VII collagen (COL7A1), the main constituent~     of anchoring fibrils which form essential structures for dermal-epidermal adherence.~      The purpose of this study is to investigate the capacity of keratinocytes and fibroblasts to~     repair skin wounds in patients suffering from Recessive Dystrophic Epidermolysis Bullosa~     (RDEB).~   "
129314|NCT01874756|"~     The primary objectives of this application are to determine if the selective ERβ agonist~     LY500307, when added to antipsychotic medications, improves negative and/or cognitive~     symptoms in patients with schizophrenia. The specific hypotheses to be tested are to~     determine if LY500307 is safe and well tolerated in this population and whether it elicits a~     sufficient efficacy signal to be advanced for further testing in schizophrenia. A two-stage~     Phase 1b/Phase 2a adaptive (drop the inferior dose) experimental design is ongoing that~     combines three studies (clinical dose optimization, cortical target engagement confirmation~     and efficacy and safety assessment) into a single clinical trial.~      Stage 1 was conducted in year 1 and Stage 2 will be conducted in years 2 and 3. The goal of~     Stage 1 was to identify and advance the highest dose that did not demonstrate a safety signal~     and had target selectivity as determined by lack of TT suppression. This criteria was~     fulfilled at both doses, the larger of the two (75 mg/day dose) was advanced to Stage 2.~     Furthermore, there was no suggestion of ERα receptor activation (i.e., no pattern of TT~     decreases or feminization AEs) at either dose (25 mg/day and 75 mg/day). A third arm of 150~     mg/day was added to Stage 2 for evaluation. Stage 2 results in the following three arms:~     placebo, 75 mg/day and 150 mg/day. The goals of Stage 2 are to further assess LY500307 doses~     for safety and target selectivity, confirm cortical target engagement and assess efficacy.~      Primary Aim 1: To determine if LY500307 demonstrates cortical target engagement as assessed~     by fMRI/N-back in frontal-parietal regions. Secondary measures of target engagement are fMRI~     episodic memory, Pseudo-Continuous Arterial Spin Labeling, Mismatch Negativity/evoked~     response potentials, Auditory Steady State Response, Auditory P300 and Quantitative EEG~     (QEEG).~      Primary Aim 2: To determine if LY500307 is superior to placebo for one or more of the primary~     efficacy endpoints: negative symptoms (Negative Symptom Assessment Scale - 16-item total~     score), working memory (the composite score for the Letter Number Sequencing and Spatial Span~     tests) and verbal memory (Hopkins Verbal Learning Test).~      Primary Aim 3: To determine if LY500307 reduces total testosterone (TT) plasma~     concentrations, which is indicative of loss of selectivity for ERβ and engagement of ERα,~     using the following criteria: Decrease in TT plasma concentrations of 50% from baseline in~     50% of subjects per arm treated for two consecutive post-randomization values with LY500307~     in Stage 1 and Stage 2 of the trial.~      Primary Aim 4: To assess the safety of LY500307 by determining if there are SAEs, AEs~     probably related to study drug, QTc prolongation, TT suppression (50% reduction from~     baseline) and to evaluate for other safety signals.~      Secondary aims are to assess LY500307 effects on regional brain activation and connectivity~     during working (2-Back visual-verbal working memory task) and episodic (scene encoding and~     recognition)and memory tasks, and to evaluate electrophysiological indices of auditory~     sensory processing and working memory (auditory steady state responses, mismatch negativity~     (MMN) and auditory P300). It is predicted that LY500307 will produce greater increases than~     placebo in brain activity in prefrontal cortex and hippocampus during the working memory and~     episodic memory tasks, respectively, connectivity during resting fMRI, as well as increases~     in power of the auditory steady state response, MMN amplitude and P300 amplitude. The fMRI~     and electrophysiological measures will provide evidence of target engagement of LY500307 in~     schizophrenia and will be assessed as potential biomarkers for future clinical trials.~     Additional secondary aims will include assessing the effects of LY500307 on safety, positive~     symptoms, depression, social functioning and quality of life.~   "
129315|NCT01874743|"~     Participating countries: France Objectives Principal objective To evaluate, in HIV-1 infected~     patients receiving effective antiretroviral therapy, the effect of the addition of~     Rosuvastatin (dose of 20mg/day) for 3 months, on CD8 T cell activation as assessed by the~     proportion of peripheral CD8 T cells that co-express the activation markers CD38 and HLA-DR~     Secondary objectives To evaluate the effect of Rosuvastatin administration on residual CD4~     and CD8 T cell activation To evaluate the effect of Rosuvastatin administration on the main~     serum soluble biomarkers of activation (CRP- HS, D-dimers, IL-6 and soluble CD14) To evaluate~     the effect of Rosuvastatin administration on CD4 T-cell count and on the CD4/CD8 T-cell ratio~     To study the relationship between the level of immune activation and the level of residual~     HIV replication in plasma To study the effect of Rosuvastatin administration on lipid~     profiles and the correlation between the HDL cholesterol and the CD4/CD8 T-cell ratio To~     evaluate the tolerance of Rosuvastatin at the dose of 20 mg/day~   "
129316|NCT01874730|"~     This is a multi-centre study to take place in approximately 3 centers in Seoul, South Korea.~     The study will be carried out as a prospective, randomized, controlled, multicenter, clinical~     trial in patients undergoing colorectal surgery. The purpose of this study is to determine if~     an enhanced recovery strategy paying close attention to the type and amount of fluid given~     during the surgery with proper monitoring combined with a comprehensive perioperative pain~     management will have a better post-operative outcome compared to institutional standard of~     care (SOC), in patients undergoing surgery of the colon. One of the fluids used, Volulyte®,~     is an intravenous solution used to treat low blood volume. The Volulyte® solution being used~     in the study and the monitor used are approved by the Korean Food and Drug Administration~   "
129317|NCT01874717|"~     Use lay language.~      To compare patient level of cooperation during dental care under conscious sedation with~     midazolam according to the administration route~   "
129318|NCT01874704|"~     A stressful state can lead to symptoms of mental exhaustion, physical fatigue, medical~     errors, and also increase coronary heart disease. Emergency physicians subjectively complain~     of stress related to changes in work shifts. Several potential biomarkers of stress have been~     described, but never investigated in emergency physician, who may represent a good model of~     stress due to the complex interplay between stress (life-and-death emergencies, which is the~     defining characteristic of their job), lack of sleep and fatigue due to repeated changes in~     shifts.The aim of this study was to compare biomarkers in emergency physicians working a~     24-hour shift (24hS) or a 14-hour night shift (14hS), and in those working a control day~     (clerical work on return from leave). We also followed these markers three days following~     each shift (D3/24hS and D3/14hS).~   "
129319|NCT01874691|"~     This study is to build a Chinese national registry and surveillance system for acute~     myocardial infarction(AMI) to obtain real-world information about current status of~     characteristics, risk factors, diagnosis, treatment and outcomes of Chinese AMI patients; And~     to propose scientific precaution strategies aimed to prevent effectively from the incidence~     of AMI; And to optimize the management and outcomes of AMI patients through implementation of~     guideline recommendations in clinical practice, and analysis and development of effective~     treatment strategies; And to create cost-effective assessment system.~   "
129320|NCT01874678|"~     Objectives:~        1. Primary Objective:~           To bridge the data of efficacy in term of overall response rate of TS-1 plus cisplatin~          in Taiwanese advanced NSCLC patients from that gained from Japanese population~        2. Secondary Objectives:~      A. To assess progression free survival B. To assess overall survival C. To bridge the safety~     profile by assessing the toxicities and tolerability~   "
129321|NCT01874665|"~     The purpose of this study is to evaluate the efficacy and safety of ponatinib in participants~     with metastatic and/or unresectable gastrointestinal stromal tumor (GIST) following failure~     of prior tyrosine kinase inhibitor (TKI) therapy.~   "
129322|NCT01874652|"~     The purpose of this study is to evaluate safety and effectiveness of Light Weight Breast~     Implant (LWBI) in breast augmentation.~   "
129323|NCT01874639|"~     Blood loss in hepatic surgery is the main factor of postoperative morbidity. The use of the~     most effective possible tool for hemostasis allows a bleeding decrease during liver~     transection and thus could reduce postoperative morbidity.~      In the past decade, the improvement of techniques of transection of the hepatic parenchyma~     was one of the most important factors to ensure the hepatectomy safety. But the clinical~     performances of these technological innovations (ultrasound dissectors, monopolar~     radiofrequency probes and dissection devices using pressurized water) remain still unclear.~      The medical device of hemostasis Aquamantys® (Salient company, Innopath) use the technology~     of transcollation combining a source of radiofrequency associated with a conductive liquid~     (NaCl 0.9% solution). The system consists of a specific generator (Aquamantys Pump~     Generator®) and single-use probes (Aquamantys 2.3 BipolarSealer®). The energy of~     radiofrequency is delivered by two bipolar electrodes. The innovative aspect of this device~     consists in maintaining the tissue to a temperature of 100°C, while using a conductive liquid~     which acts as process of cooling and avoids the drying out of tissues, smoke, risks of~     electric arc and overheating met with conventional electrosurgery. This device allows the~     coagulation of blood vessels but also bile ducts. The Aquamantys® system could decrease the~     postoperative morbidity and mortality due to a decrease of blood loss and biliary leak. These~     clinical benefits could be translated by an improvement of the direct and indirect costs~     associated to the surgery. However the Aquamantys® technology has not been scientifically~     validated in the context of the hepatic surgery, and this technology is expensive due to the~     purchase of single-use bipolar probes (Aquamantys 2.3 BipolarSealer®) and to the investment~     in a generator (Aquamantys Pump Generator®).~      Consequently, it is essential to realize a study measuring the clinical and medical economic~     impact of the transcollation technology (Aquamantys® device) in the hepatic surgery.~   "
129324|NCT01874626|"~     This is a randomized, multi-center, double-blind, placebo-controlled, multi-dose,~     parallel-group study. Approximately 300 subjects (150 per group) 16 years of age and older~     with a current (within 24 hours from Visit 1) Grade I or II ankle sprain, and who meet all~     eligibility criteria, will be randomized into the study and will receive either the active~     treatment (SST-0225 ibuprofen cream), or matching placebo. Subjects will apply an amount~     equivalent to a 4 inch line of investigational product to the affected ankle approximately~     every 4-6 hours. At Visit 1 two doses will be applied at the site. All subsequent doses of~     the investigational product will be applied every 4 to 6 hours with a total of 4 doses in a~     24 hour period. Duration of treatment with the investigational product is 7 days.~   "
129325|NCT01874613|"~     Bioactive fibre-reinforced composite implant is used for reconstruction of skull bone defects~     and orbital floor defects.~      Functional and aesthetic outcome is assessed by patient and doctor.~   "
129326|NCT01874600|"~     The seizure detection and warning system is an ambulatory system designed to monitor and~     analyze EMG data to detect the onset of GTC seizures and to provide a warning signal to alert~     caregivers that a seizure is occurring.~   "
129327|NCT01874587|"~     The Phase III study will include 174 patients with locally advanced oropharynx carcinoma,~     receiving all arc-IMRT (Intensity-Modulated Radiation Therapy) (70 Gy) with concomitant~     systemic therapy. Two arc-IMRT treatment arms will be compared: one standard arm based on~     the use of a single pre-treatment planning and one experimental arm (adaptive RT) based on~     a weekly replanning to spare the salivary glands. The main objective is to increase by 25%~     the salivary flow (Parafilm) 12 months after RT thanks to adaptive RT, while not decreasing~     local control. The secondary objectives are to increase the salivary flow (scintigraphy),~     reduce xerostomia, acute and late toxicities (Eisbruch questionnaire, MDAS-HN, v.4 CTCAE),~     while maintaining local control (stopping rule of the trial if difference>15%). 174 patients~     will be included in 6 French centers for 2 years and followed for 2 years. The HPV (Human~     Papillomavirus) status will be identified and the tumors frozen. A central IMRT QA (Quality~     Assurance) will be performed.~   "
129328|NCT01874574|"~     Corticosteroid and Hylan G-F 20 are both effective in improving pain and function of~     osteoarthritic knee patients.~   "
129329|NCT01874561|"~     This is a 3-arm, parallel-group, active- and placebo-controlled, double-blind, randomized~     study, to compare treatment with intravenous custirsen at 640 mg (highest intended~     therapeutic dose) with placebo. The purpose of this study is to assess the effect of~     custirsen treatment on cardiac conduction and repolarization (electrical activity of the~     heart) in healthy subjects. The positive control employed to demonstrate assay sensitivity~     consists of a group receiving a single oral dose of 400 mg moxifloxacin on day 7. The~     moxifloxacin arm is un-blinded but the ECG readings are blinded.~   "
129330|NCT01874548|"~     The purposes of this study are: (1) to develop magnetic resonance (MR) imaging and~     spectroscopy as surrogate biomarkers for altered cancer metabolism in cervical cancer; (2) to~     understand the function of human papillomavirus (HPV) infection and autophagy (a cellular~     catabolic degradation response to stress) in the metabolic alterations in cervical cancer.~   "
129331|NCT01874535|"~     To investigate the impact of initial treatment duration (4-week versus 8-week)of Esomeprazole~     (40mg) on the rate of symptom relapse and sustained healing of esophagitis in patients with~     symptomatic erosive esophagitis~   "
129332|NCT01874522|"~     The purpose of this study is to compare the bioavailability of TAS-102 tablets to an oral~     solution containing equivalent amounts FTD and TPI.~   "
129333|NCT01874509|"~     Alcohol is one of the leading contributors to premature mortality and disability. Most people~     with alcohol problems will never seek treatment. There is a need to develop alternate ways to~     help problem drinkers outside of formal treatment settings.~      One promising strategy is Internet-based interventions for problem drinkers. The first~     randomized controlled trial found that the investigators could reduce alcohol consumption by~     about six drinks per week at a six-month follow-up using a minimal, personalized feedback~     Internet-based intervention. The investigators second randomized trial demonstrated that an~     extended Internet-based intervention that contained a range of cognitive-behavioural and~     relapse prevention tools could produce greater reductions in problem drinking compared to~     that provided by the same minimal intervention at a six-month follow-up. Building upon this~     research, the current project will assess whether this extended Internet-based intervention~     can have a sustained impact on problem drinking. Specifically, the major objective of this~     project is to conduct a randomized controlled trial comparing the impact of an extended~     Internet-based self-help intervention for problem drinkers to a minimal Internet-based~     intervention in the general population of problem drinkers over a two year period.~      Problem drinking participants will be recruited through media advertisements across Canada~     and will be randomly assigned to the minimal or extended Internet-based interventions.~     Six-month, twelve-month and two-year drinking outcomes will be compared between experimental~     conditions. It is predicted that participants receiving the extended Internet intervention~     will display sustained improved drinking outcomes compared to participants in the minimal~     Internet intervention condition. This programmatic line of research will advance the science~     of Internet-mediated intervention.~   "
129334|NCT01874496|"~     Slow release iron capsules have been designed based on the gastric delivery system. Iron~     absorption from those capsules administered with and without meals will be measured using~     stable iron isotopes.~   "
129335|NCT01874483|"~     To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 187004~     following multiple dose administration over 14 days.~   "
129336|NCT01874470|"~     The purpose of ALLEGRO-HTN trial is to evaluate the safety and effectiveness of renal~     denervation in subjects with resistant hypertension by using Allegro renal denervation system~   "
129343|NCT01874379|"~     In the M-TIJRP protocol the investigators will utilize two Integrative Medicine modalities in~     a randomized, controlled study using either the 'M'-Technique® developed by Jane Buckle, PhD~     or Diane L. Tusek's Guided Imagery for Pre-Procedure/Surgery™ with nature sounds to determine~     their effects on a specific group of pre- and post-operative patients, compared to no~     integrative medicine intervention - considered Standard of Care. A total of 225 patients~     undergoing surgical hip or knee replacement will participate; one third of the patient~     population will receive the 'M'-Technique touch intervention, one third will receive Tusek's~     Guided Imagery intervention delivered by headsets monitored by therapists from our Center for~     Complementary Medicine (CCM) and one third will comprise the control group, consisting of~     routine preoperative & postoperative care without integrated intervention.~      Patients will be asked to complete Pain and Anxiety scales at four different timepoints~     throughout their hospital stay. These will occur at Same Day Surgery (pre-operatively), and~     Post Operatively Day 0, Day 1 & Day 2.~      Rationale: Patients are often at their most vulnerable just prior to surgery when their~     stress and anticipation are high and again immediately afterward when their energy is lower~     and their bodies are trying to accommodate after an invasive procedure. In addition, the~     patient and his or her family sense a lack of control and feel a rise in anxiety over the~     possible outcomes. This stress, anxiety, and pain associated with surgery and recovery can~     increase complication rates and slow recovery times resulting in longer hospital stays.~   "
129344|NCT01874366|"~     -  Study to Determine the Safety, Tolerability, Pharmacokinetics, Food Effect and~          Pharmacodynamics of Single and Multiple Ascending Doses of P11187~        -  It will be conducted in three parts, as described below:~        -  Part I will be the Single Ascending Dose (SAD) study~        -  Part II will be the Multiple Ascending Dose (MAD) study~        -  Part III will be the food effect evaluation~   "
129345|NCT01874353|"~     A Phase III, randomised, double-blind, placebo-controlled, multi-centre study to assess the~     efficacy of olaparib maintenance monotherapy in relapsed high grade serous ovarian cancer~     (HGSOC) patients (including patients with primary peritoneal and / or fallopian tube cancer)~     or high grade endometrioid cancer with BRCA mutations (documented mutation in BRCA1 or BRCA2~     that is predicted to be deleterious or suspected deleterious (known or predicted to be~     detrimental/lead to loss of function)) who have responded following platinum based~     chemotherapy.~   "
129346|NCT01874340|"~     To evaluate the efficacy and safety of AIN457 versus placebo in patients with relapsing~     multiple sclerosis.~   "
129347|NCT01874327|"~     The study will evaluate the efficacy of a novel intervention implemented in a classroom~     setting aimed at improving joint attention and joint engagement skills with infants who are~     at risk of developing an Autism Spectrum Disorder.~   "
129348|NCT01874314|"~     This will be a single center, open label, crossover study to evaluate the safety and~     tolerability of multiple dose levels of SQ109.~   "
129349|NCT01874301|"~     Gastrointestinal discomfort regularly affects >25% of the population worldwide. One of the~     major contributors to Gastrointestinal discomfort is constipation, which has a prevalence of~     ~15%, and symptoms of which have a significant negative impact on the sufferer's quality of~     life. One of the hallmarks of chronic constipation is slow progression of contents through~     the gut (i.e. slow gut / colonic transit time), which may be associated with hard stools that~     are difficult to expel. Previous studies have shown that probiotics improve colonic transit~     times in constipated patients. In addition, several other studies, employing a range of~     different probiotic strains, have shown a significant increase in defaecation frequency and~     improvement in stool consistency. However, the clinical relevance of these results is~     uncertain, due to small sample sizes and limitations in study methodology. The current study~     is designed to compare changes in gut transit time and gastrointestinal symptoms following 4~     weeks consumption of a probiotic strain in a randomized, double-blind, placebo-controlled~     manner, in adults with constipation.~   "
129350|NCT01874288|"~     An open-label, dose-escalation trial of the safety, tolerability, pharmacokinetics (PK),~     biological, and clinical activity of DI-Leu16-IL2 administered to patients with CD20~     (B-lymphocyte antigen CD20) positive Non-Hodgkin Lymphoma (NHL) that have failed standard~     rituximab-containing therapy. Following peripheral blood B cell depletion with rituximab (if~     needed) each patient will receive DI-Leu16-IL2 administered as a subcutaneous (SC) injection~     for three consecutive days every three weeks.~   "
129351|NCT01874275|"~     The primary objective of this investigation is to assess the effectiveness of transcutaneous~     electrical nerve stimulation applied using VECTTOR to reduce the symptoms of Duchenne~     Muscular Dystrophy and reduce the impact of DMD upon the participants' quality of life.~      The primary outcome measures will include:~        1. increased muscle strength,~        2. increased range of joint motions and~        3. improved sleep parameters of ASI, N3 and REM.~   "
129352|NCT01874262|"~     The purpose of this study is to evaluate whether the mobile-phone based patient support has~     an impact on the adherence and persistence of ticagrelor treatment or on lifestyle changes~     that will have a positive impact on the cardiovascular risk factors.~   "
129353|NCT01874249|"~     The purpose of this randomized clinical trial is to evaluate the utility of noninvasive~     markers for the detection of advanced fibrosis in patients newly diagnosed with Non-alcoholic~     Fatty Liver Disease (NAFLD) by ultrasound.~      The primary objective is to determine the effectiveness of noninvasive markers for detect of~     advanced fibrosis in patients with diagnosis of fatty liver disease.~      The secondary objectives are:~        -  To determine the increase in health care with the specialist (gastroenterologist or~          endocrinologist).~        -  To determine which noninvasive evaluation strategy favors any treatment of fatty liver~          disease.~   "
129354|NCT01874236|"~     The purpose of the trial is to confirm the validity and reliability of diagnostic SI joint~     blocks.~   "
129378|NCT01873924|"~     This study aims to assess the natural history of Batten disease by obtaining information~     about the motor, behavioral, and functional capabilities of individuals with Batten disease~     (Neuronal Ceroid Lipofuscinosis). This study will also refine and validate the Unified Batten~     Disease Rating Scale (UBDRS) as a clinical rating instrument for Batten disease.~   "
129556|NCT01871584|"~     The aim of this study is to demonstrate the efficacy of the hydrocolonic lavage method in~     order to prepare the colon prior to performing a colonoscopy, by comparison the hydrotherapy~     to standard preparation solution.~      Hypothesis: Colon cleansing by hydrotherapy is as good as colon cleansing by standard~     preparation solution.~   "
129355|NCT01874223|"~     The purpose of this study is to test cough, dyspnea (shortness of breath), and quality of~     life (QOL) questionnaires for their accuracy, sensitivity, and ability to reliably measure~     the severity of cough, breathlessness, and changes in cough and disease-related quality of~     life over time in Idiopathic Pulmonary Fibrosis (IPF) patients. These questionnaires have~     been used in other types of disease, but have not all been tested and validated in patients~     with cough due to IPF. Our hypothesis is that worsening of cough, dyspnea, and cough-related~     QOL questionnaire scores will correlate with physiologic markers of IPF severity and~     worsening of disease. Written, valid questionnaires measuring cough, dyspnea, and QOL are~     important to assess the benefit of investigational drugs under development to treat patients~     with IPF.~   "
129356|NCT01874210|"~     Chronic kidney disease is associated with the accumulation of various metabolites, i.e.,~     uremic retention solutes. Evidence is mounting that the colonic microbiome contributes~     substantially to these uremic retention solutes. Indoxyl sulfate and p-cresyl sulfate are~     among the most extensively studied gut microbial metabolites, and are associated with~     cardiovascular disease, chronic kidney disease progression and overall mortality. Indirect~     findings suggest that chronic kidney disease influences the colonic microbial metabolism with~     higher p-cresyl sulfate urinary excretion rates at more advanced renal disease. Therefore,~     this study aims to elucidate the influence of renal dysfunction on microbial metabolism and~     to test the hypothesis that chronic kidney disease patients carry a different fecal~     metabolite profile.~   "
129357|NCT01874197|"~     An investigator-initiated, prospective, consecutively enrolling, non-randomized single~     institution clinical evaluation of the safety and effectiveness of physician modification of~     a currently FDA-approved off the shelf thoracic aortic stent graft (COOK Zenith® TX2®) to~     preserve branch vessels when used in the treatment of patients with thoraco-abdominal aortic~     aneurysms.~      The primary objectives of this study are to determine whether physician modified branched~     endovascular grafts are a safe and effective method of treating patients with~     thoraco-abdominal aortic aneurysms.~   "
129358|NCT01874184|"~     This randomized clinical trial studies a group-based lifestyle intervention or usual care in~     measuring biomarker levels in participants at high risk for breast cancer. Studying the~     effects that changes to daily eating and exercise habits can have on the body's hormone~     levels and the body's ability to activate proteins may help doctors identify interventions~     for individuals at high risk for breast cancer.~   "
129359|NCT01874171|"~     Oropharyngeal squamous cell carcinoma (OPSCC) incidence is increasing rapidly in the~     developed world. This has been attributed to a rise in Human Papillomavirus (HPV) infection.~     HPV+OPSCC is considered a distinct disease entity, affecting younger patients and has a good~     prognosis following treatment. Subsequently, patients can live with the considerable side~     effects for several decades.~      Radiotherapy and cetuximab (Epidermal Growth Factor Receptor-inhibitor) have demonstrated~     similar efficacy to 'platin' chemoradiotherapy (current standard treatment containing~     platinum-based compounds) in head and neck cancer, but is potentially less toxic.~      Results of this trial will be used to determine the optimum treatment of this debilitating~     cancer, with the primary aim of decreasing toxicity and improving quality of life for~     HPV+OPSCC patients.~   "
129360|NCT01874158|"~     The objective of this study is to screen treated Trichomonas vaginalis (TV) positive women~     weekly using culture and Polymerase Chain Reaction (PCR) to determine how long TV DNA is~     detectable post treatment and to examine potential confounders to clearance such as bacterial~     vaginosis.~   "
129361|NCT01874145|"~     This is an open-label, randomized, multi-center, parallel-arm study to assess the safety and~     tolerability of a daily dose of Glatiramer Acetate (GA) 40 mg/mL three times a week (TIW)~     administered subcutaneously (SC) as compared to GA 20 mg/mL every day (QD) administered SC.~   "
129362|NCT01874132|"~     Cardiovascular diseases (CVD) represent the most frequent cause of death among the elderly~     population. Hypertension, unfavorable lipid profile, obesity and physical inactivity are~     among the main risk factors for CVD. In contrast, mortality from CVD is inversely related to~     levels of physical activity, and is lower in individuals who exercise and have higher~     functional fitness levels. Thus, the Centers for Disease Control and Prevention, the American~     College of Sports Medicine, and the American Heart Association have recommended 20-30 min of~     moderate-to-vigorous aerobic training for the elderly, preferably every day or at least 3~     days a week in the case of vigorous exercise.The same organizations also suggest the~     inclusion of resistance training in order to improve functional fitness. Therefore, the~     purpose of this study was to compare different exercise modalities in long-term changes of~     CVD risk factors and physical fitness among older adults.~   "
129363|NCT01874119|"~     The purpose of this study is to investigate the effectiveness of intravenous fosaprepitant~     therapy to reduce nausea and vomiting during the treatment of high dose interleukin-2 (HD~     IL-2) therapy for metastatic melanoma or metastatic renal cell carcinoma. Fosaprepitant is an~     intravenous (IV) medication that is FDA- approved for use in adults for the prevention of~     nausea and vomiting during chemotherapy. Fosaprepitant works by blocking the neurokinin-1~     receptor, which is a receptor in the brain that is known to cause nausea and vomiting. Past~     studies estimate that up to 70% of patients undergoing treatment with HD IL-2 will have~     nausea and/or vomiting. While fosaprepitant has been used in clinical practice to treat~     nausea and vomiting during HD IL-2, there have not been any studies done to see how well it~     works. All patients will receive treatment (IV fosaprepitant) during the study during either~     the first or second hospital admission for HD IL-2. On the admission that the subject is not~     receiving IV fosaprepitant, the subject will receive placebo (a medicine that looks like~     fosaprepitant, but is not active). The study is double-blinded, which means neither the~     subject, nor the study doctor will know to which group you have been assigned to that~     admission (IV fosaprepitant or placebo). This study design was chosen to limit the potential~     for bias, which means the trial was designed to try to ensure that unknown factors do not~     affect trial results. When patients start the study, patients will be randomly assigned to~     one of two groups: those who receive treatment (IV fosaprepitant) first and those who receive~     placebo first. During the first admission, subjects will be given the IV fosaprepitant or IV~     placebo during admission. During the second admission, subjects will 'crossover' and receive~     the other treatment that they did not receive during the first admission. Improvement in~     nausea and vomiting will be assessed by counting the number of nausea and vomiting episodes,~     recording if the subject needs additional medication for nausea and vomiting, and by using~     patient questionnaires.~   "
129364|NCT01874106|"~     The purpose of this study is to evaluate the effect of especial diet therapy~     Anti-inflammatory Diet on inflammatory, oxidative stress, and nutritional markers in the~     context of protein-energy wasting syndrome(PEW) in hemodialysis patients.~   "
129365|NCT01874093|"~     The primary objective of the study is to assess the safety and effectiveness of SPG~     stimulation with the ISS in a 24 hour window, in patients with an acute ischemic stroke in~     the anterior circulation, who received Mechanical Thrombectomy and/or IV-rtPA and Standard of~     Care.~   "
129366|NCT01874080|"~     The purpose of this study is to determine if tablets manufactured at different sites have the~     same bioavailability, that is yield similar blood levels/concentrations of the drugs and are~     handled by the body similarly~   "
129367|NCT01874067|"~     This is a collaborative study with 11 Occupational Therapy (OT) departments in North-West~     England. The OTs provide arthritis gloves to 25% of out-patients with inflammatory,~     rheumatoid and osteoarthritis. The pressure applied by the glove(s) may help relieve hand~     pain, swelling and stiffness. People find they help but there is little research testing~     this. Of the five small studies published: two found little or no benefit; one found similar~     effects from arthritis and ordinary thermal gloves; two found some benefits. Testing if~     gloves work helps therapists and patients judge if they will help.~      This is a feasibility study to help us plan a future trial testing if arthritis gloves work~     for people with arthritis. We aim to find out: the rate we can recruit people to the study;~     if OTs can assess people's hands and provide gloves as agreed; how many people do we need to~     take part in a trial; what do people think (if any) is the gloves' most important effect and~     how long should we test them for? We will analyse the data to see what effect the gloves~     have.~      The study will last 12 months. People will get arthritis gloves as part of their usual care.~     The OTs have agreed a standard way of assessing and providing the gloves to ensure best~     practice across departments. The assessments include: difficulties using hands, pain and~     stiffness levels, and measuring hand and finger joint size and movement. People can take part~     if they: have one of the three types of arthritis; are willing to wear Isotoner three-quarter~     length gloves; can attend the usual 4 week review appointment for re-assessment; will allow~     us to use their anonymized hand assessments. We will also interview some people about their~     views of the assessment and their treatment. Each patient will be involved for 4-8 weeks.~   "
129368|NCT01874054|"~     The purpose of this study is to assess safety and efficacy of brentuximab vedotin in~     combination with bendamustine in patients with relapsed or refractory Hodgkin lymphoma. It is~     an open-label, 2-stage study designed to determine the recommended dose level of bendamustine~     in combination with brentuximab vedotin. The study will assess the safety profile of the~     combination treatment and determine what proportion of patients achieve a complete remission.~   "
129369|NCT01874041|"~     The objectives of this study were to investigate the effects of massage therapy and occlusal~     splint therapy in the electromyographic activity and mandibular range of motion (ROM) in~     individuals with temporomandibular disorder (TMD) and compare the results with those obtained~     in a group of individuals without this disorder. Twenty-eight volunteers with TMD were~     randomly distributed into two groups, massage therapy and occlusal splint. Both treatments~     lasted 4 weeks. Fourteen individuals without TMD were consecutively allocated to the control~     group. The Fonseca's anamnestic index was used to characterize TMD and allocate the~     volunteers to either the intervention groups or control group. The electromyographic activity~     and Mandibular ROM was evaluated before and after treatment using a digital caliper. Two-way~     analysis of variance with the Bonferroni test was used for inter and intragroup comparisons~     (level of significance was set to 5%). Cohen's d was used to calculate the effect size.~   "
129370|NCT01874028|"~     To evaluate the effects of a single dose of trientine in children ≥6 years and adult patients~     with Wilson's disease.~   "
129371|NCT01874015|"~     This study is a prospective, randomized, parallel, phase 1 trial to assess the safety and~     feasibility of the transplantation of bone marrow derived mesenchymal stem cells (MSCs) in~     fistulizing Crohn's disease.~   "
129372|NCT01874002|"~     Patients with stenosis in one or more coronary artery are often treated with a percutaneous~     coronary intervention (PCI). As part of the PCI treatment a stent is often placed to keep the~     vessel open over time.~      The Combo-Stent is a novel stent for use during percutaneous angioplasty. In short, the Combo~     stent combines a drug eluting technique and an endothelial cell attracting layer. The drug~     coating is designed to prevent re-narrowing of the stent. The endothelial cell attracting~     layer is designed to ensure rapid coverage of the stent struts with vascular wall cells.~      The REMEDEE REGISTRY evaluates the long-term safety and performance of the Combo stent in~     routine clinical practice. In total 1000 patients will be registered and followed for five~     years.~   "
129373|NCT01873989|"~     This study is designed to develop an effective treatment intervention for chronic pain,~     symptomatic hypogonadism, and opioid addiction~   "
129374|NCT01873976|"~     Cardiomyopathy is a disease of the heart muscle. It is rare, but it can be serious.~     Cardiomyopathy in children can result in death, disability, heart transplantation or serious~     heart rhythm disorders. Natural substances in the blood called cardiac biomarkers can be~     measured in the laboratory and could be a less invasive way (compared to echocardiograms or~     MRIs) to detect heart dysfunction in children with cardiomyopathy. Little is known about how~     useful and valid cardiac biomarkers are in the diagnosis and determination of the symptoms in~     children with cardiomyopathy. The long-term goal of this project is to study how helpful~     measuring cardiac biomarkers in children with cardiomyopathy is to their doctors in managing~     the care of these patients as well as improving their overall health. Measures of these~     cardiac biomarkers could help doctors in determining how best to care for a child with~     cardiomyopathy, including when to consider heart transplantation as a treatment option.~   "
129375|NCT01873963|"~     Cardiomyopathy in children is a serious disease which can result in death, disability, heart~     transplantation or serious heart rhythm disorders. Doctors know little about the causes of~     cardiomyopathy but would like to learn more. In fact, up to 50-75% of cases in children have~     no known cause. For this reason, the purpose of this study is to identify genes that cause~     cardiomyopathy or that influence how people with cardiomyopathy do over time. These findings~     could improve disease prevention, surveillance, early management, and prognosis.~   "
129376|NCT01873950|"~     This study seeks to compare 4 known QT prolonging drugs versus placebo to determine their~     effects on electrophysiological and other clinical parameters. The underlying purpose is to~     determine if depolarization and repolarization effects caused by drugs with differing ionic~     channel mechanisms can be distinguished from one another, and to gauge the sensitivity and~     specificity of novel signal analyses for detection of depolarization and repolarization~     changes. Secondarily, to evaluate the exposure response relationship and drug induced effects~     on the heart rate biomarker relationship.~   "
129377|NCT01873937|"~     Low intensity laser therapy (LILT) has been widely applied in pain relief in several clinical~     situations. With the advent of new LED-based (light emitting diode) light sources, the need~     of further clinical experiments aiming to compare the effectiveness between them is~     paramount.~   "
129379|NCT01873911|"~     Hypothesis #1: Factor analysis of the revised Sanfilippo Behavior Rating Scale (SBRS) will~     identify a group of externalizing behaviors and a group of Klüver-Bucy syndrome-like~     behaviors as two different factors that are at least partially independent.~      Hypothesis #2a: Children with MPS III will show more hyperlocomotion, fearlessness,~     asociality and noncompliance than children of similar cognitive ability with MPS I.~      Hypothesis #2b: These behaviors will become more frequent and/or intensify over time,~     consistent with the Cleary and Wraith (1993) model. Quantifying them will provide a more~     empirical framework for staging disease progression.~      Hypothesis #3: Brain volumetric analysis and diffusion-tensor imaging will reveal~     abnormalities of frontal and temporal lobe structures that will correlate with externalizing~     and Klüver-Bucy syndrome-like behaviors, respectively.~      Hypothesis #4. Loss of cognitive and language function as measures of neurologic decline will~     directly precede or co-vary with behavioral decline.~      The primary objective of this study is to identify the behavioral phenotype and its neural~     basis in MPS III (Sanfilippo syndrome). Is the behavioral phenotype similar to that of~     Klüver-Bucy syndrome, and is there evidence for amygdala abnormality? The secondary objective~     of this research study is to develop easily administered, sensitive and specific~     neurobehavioral and neuroimaging markers to characterize the behavioral phenotype(s) of MPS~     III; to track their progression; and to delineate their neural substrates. Such markers are~     critical for identifying the stage of disease for each patient, and to measure treatment~     outcome. Although we know that severe cognitive decline is one essential characteristic of~     MPS III, the other highly salient characteristic is a range of abnormal and disruptive~     behaviors that can include, but go well beyond, childhood noncompliance and oppositionality.~     These behaviors set Sanfilippo syndrome apart from the other MPS disorders. They cause major~     disruption in the child's familial, school, and community environments. Delineating these~     behavioral abnormalities will help in better understanding the neurological disease.~   "
129380|NCT01873898|"~     The purpose of this study is to evaluate the safety and efficacy of the Rex Medical Closer™~     Vascular Closure System to close the femoral arterial puncture site in subjects who have~     undergone diagnostic angiography procedures with early ambulation and discharge.~   "
129381|NCT01873885|"~     This study is an exploratory Phase 1 randomized, double-blind (Investigator and study subject~     and 2-D echo endpoint assessor), placebo-controlled single IV infusion dose escalation study~     that will enroll up to approximately 32 subjects with stage 1 or 2 essential hypertension.~   "
129382|NCT01873872|"~     We have designed this study to measure the effect of normal flora supplementation, using~     available probiotics, on the incidence of Clostridium difficile-associated diarrhea~      in a population of general inpatients who are receiving antibiotics.~   "
129383|NCT01873859|"~     The purpose of this study is to determine whether metformin causes lactic acidosis in~     diabetic patients with preserved kidney function, undergoing coronary angiography or~     angioplasty with new contrast media.~      In other words is it necessary to discontinue metformin before these procedures, even when~     Iodixanol is used as contrast media, which is isosmolar agent and much more safer than~     urografin which was the main agent in the previous studies that were the base of present~     guidelines?~   "
129384|NCT01873833|"~     This phase II trial studies how well capecitabine, cyclophosphamide, lapatinib ditosylate,~     and trastuzumab work in treating patients with human epidermal growth factor receptor 2~     (HER2)-positive metastatic breast cancer. Drugs used in chemotherapy, such as capecitabine~     and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Giving capecitabine and cyclophosphamide~     daily may kill more tumor cells. Lapatinib ditosylate may stop the growth of tumor cells by~     blocking some of the enzymes needed for growth. Monoclonal antibodies, such as trastuzumab,~     can block tumor growth in different ways. Some block the ability of the tumor to grow and~     spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.~     Giving capecitabine, cyclophosphamide, lapatinib ditosylate, and trastuzumab together may be~     an effective treatment for breast cancer.~   "
129385|NCT01873820|"~     The purpose of this study is to compare the tolerance of two forms of vitamin C in adults~     with sensitivity to acidic foods.~   "
129386|NCT01873807|"~     Intensified conditioning regimen allo-HSCT is based on a hypothesis of that intensifying~     condition with less-used drugs could overcome resistance,reduce tumor burden, and most~     importantly, spare enough time for slow-growing GVL effect following immune reconstitution to~     finally get rid of MRD and control the disease. Our previous trial of HDE-ALL-2011~     (NCT01457040) have confirmed the role of intensified conditioning allo-HSCT in adult ALL,~     resulting in significantly improved OS and EFS in comparison with previous standard TBI/CY2~     conditioning regimen(data not yet published). But at the same time, FA-TBI/CY2-VP16~     conditioning regimen was associated with high transplantation-related mortality (TRM), which~     might be attributed to excessive suppression on both bone marrow and immune. TT-ALL-HIE-2013,~     substituting FA with idarubicin, is aimed at maintaining anti-tumor effect with less~     cross-resistance and immune suppression and reducing TRM.~   "
129387|NCT01873794|"~     Cancer related fatigue (CRF) - a persistent sense of exhaustion related to cancer or cancer~     treatment - can severely interfere with activities of daily living, and has even been~     reported to be a factor in patient requests for hastened death. CRF can represent a serious~     clinical problem years after all treatment has ended. There is currently no effective~     treatment for CRF. The purpose of this study is to investigate whether systematic exposure to~     light (from a commercially available Litebook) reduces CRF or other symptoms.~   "
129388|NCT01873781|"~     Age related cataracts are responsible for about 51 percent of blindness worldwide and~     according to the WHO affect about 20 million people, according to the WH . As cataract~     surgery is firstline treatment in the western world, there is a constant attempt to improve~     artificial intraocular lenes (IOL).~      As for this study, the investigators seek to compare four different IOL designs in in a~     psychophysiological setting, allowing to assess the impact of these IOLs on vision and~     psychological processing of visual information.~      As these IOLs also have downsides, such as reduced light intensity or image alterations, the~     subjective preference and overall impression shall be investigated. The healthy subjects look~     through a stable spectacle frame mounted onto a table, which enables the investigator to~     insert the different IOLs. This would allow subjective testing of IOLs before surgery.~   "
129389|NCT01873768|"~     Tranexamic acid (TXA) and ε-aminocaproic acid (EACA) are two drugs shown to limit blood loss~     following major surgery, from cardiac to orthopedic procedures. Yet compared to tranexamic~     acid (TXA), research on the clinical impact of ε-aminocaproic acid (EACA) in total knee~     arthroplasty (TKA) is limited. The primary aim of this study is to determine whether TXA and~     EACA provide similar blood decreasing effects following TKA or whether one drug provides a~     superior effect over the other in reducing patients' blood loss.~   "
129628|NCT01870635|"~     The primary objective is to determine if the administration of a single dose of oral~     ondansetron (an anti-vomiting medication), compared to placebo, results in a reduction in~     intravenous (IV) rehydration therapy in children presenting for emergency department care~     with vomiting and diarrhea in Pakistan.~   "
129391|NCT01873742|"~     Feedback in psychotherapy involves clients monitoring therapy process and progress, and on a~     frequent basis clients register these data into online questionnaires. These data are then~     fed back to the therapist, hence informing about the process and progress in therapy. This~     information can be shared with the client, something that may enhance the client involvement~     in evaluating and planning of the therapy. The same data can be used for research purpose.~     This randomized controlled multicenter study within Norwegian couple and family contexts will~     explore the effects of feedback in natural settings, and it collaborates closely with a~     similar American study in Chicago/Evanston, Ill.~   "
129392|NCT01873729|"~     The primary aim of this study is to assess whether naltrexone as a monotherapy is effective~     in treating Attention Deficit Hyperactivity Disorder (ADHD) in adults. Medications that~     increase dopamine are often effective in treating ADHD in adults. Since naltrexone is a kappa~     opioid receptor antagonist, it increases dopamine in the brain.~      We predict that naltrexone as a monotherapy will be effective for ADHD symptoms in adults~     with ADHD.~   "
129393|NCT01873716|"~     This will be a pilot study of 9 patients undergoing standard-of-care clinically indicated~     carotid endarterectomy. The nine patients will receive an injection of Indocyanine green~     (ICG) at a dose of 0.25 mg/kg (maximum 25 mg) as an intravenous bolus.~      Immediately following endarterectomy, the resected specimen will be immersed in normal~     saline. Ex vivo fluorescence reflectance imaging (FRI) and immunohistochemistry will be~     performed.~      The investigators hypothesize that compared to controls, ICG-injected patients will~     demonstrate increased ex vivo and microscopic ICG fluorescence signal within areas of plaque.~   "
129394|NCT01873703|"~     The purpose of this randomized, double-blind, placebo-controlled study is to determine the~     safety and efficacy of pracinostat compared to placebo when combined with azacitidine, and~     FDA approved treatment for Myelodysplastic Syndrome (MDS).~   "
129395|NCT01873690|"~     The purpose of this research study is to test whether administering one dose of an antibiotic~     before a routine shock wave lithotripsy procedure is more effective at avoiding any urinary~     infections compared to not taking an antibiotic. This is an important topic to study because~     urinary tract infections are one of the most common complications after this procedure and~     there is no clear standard of care regarding the use of pre-procedure antibiotics. Our study~     results will benefit future patients either by decreasing the rate of infections or~     decreasing the use of unnecessary antibiotics.~   "
129396|NCT01873677|"~     This study is to evaluate the efficacy and safety of M518101 in subjects with plaque~     psoriasis.~   "
129397|NCT01873664|"~     The purpose of this study is to examine the possibility of using jaw-tapping training as a~     self-exercise for developing memory and preventing dementia in elderly subjects with memory~     disturbances using functional magnetic resonance imaging (fMRI).~   "
129398|NCT01873651|"~     The aim of the study is to describe the results after > 10 years due to a prosthesis implant.~   "
129399|NCT01873638|"~     Minlaparotomy (MC) and laparoscopic cholecystoctomy (LC) are commonly applied surgical~     techniques for the management of symptomatic gallstone disease and both techiques have shown~     to be feasible for day surgery. However, to our knowledge the long-term outcome between these~     approaches has not been compared in randomised trials as day surgery procedures.~   "
129400|NCT01873625|"~     Osteoarthritis of the knee is one of the most common causes of disability among elderly.~     Arthritis rheumatoid is an autoimmune disease which causes multi articular arthritis, such as~     knee osteoarthritis. As the disease progresses the cartilage become frustrated, surrounding~     bone react to become thicker and inflammation occurs in subchondral bone seen in T2-weighted~     MRI as increase in signal density. Patients are treated initially by pain management. In~     patients who don't response to first line treatment invasive treatment like total knee~     replacement is done. The investigators designed this clinical study with the aim of~     evaluating therapeutic effects of intra-articular injection of bone marrow mesenchymal stem~     cells (BM-MSCs) in 60 patients with knee osteoarthritis.~   "
129401|NCT01873612|"~     The overall aim with this project is to investigate the effect of dexmedetomidine on control~     of breathing in healthy volunteers and to compare it with propofol at the same degree of~     sedation.~   "
129402|NCT01873599|"~     In this study the investigators plan to recruit 70 patients reporting high levels of stress~     to test the impact of Positive Affect Journaling. Patients randomized to use the online~     intervention will be asked to journal about one of seven topics, several days each week, for~     three months. The topics (e.g., What went well) are designed to help the individual focus~     on some positive aspect of their life or themselves over the past day. Each topic is based on~     prompts shown to be effective in studies of up to one week in duration. In the summer of~     2012, our research team pilot tested each prompt with 20 patients with high levels of~     anxiety, which led to important changes to the prompts, to increase their potential impact.~     The main aim is to understand the impact of Positive Affect Journaling on psychological~     distress, as measured by the National Health Interview Survey.~   "
129403|NCT01873586|"~     The objective of this study is to prospectively evaluate the performance of Integra's~     OsteoStrux Collagen Ceramic Scaffold combined with bone marrow aspirate as an adjunct for~     instrumented posterolateral spine fusion, as compared to local autograft.~   "
129404|NCT01873573|"~     The purpose of this pilot study is to find out if adding triamcinolone (steroid) injection at~     the participant's initial esophagogastroduodenoscopy (EGD) procedure will improve the opening~     of their esophagus and decrease the need for repeat dilations.~   "
129405|NCT01873560|"~     Fractional flow reserve (FFR) is a physiologic index for the determination of~     ischemia-causing coronary stenosis as well as drug eluting stent (DES) optimization, even~     multiple anatomic imaging parameters have been widely used in clinical practice for the~     assessment of optimal stent procedure. Prognostic value between post-stent FFR (FFRpost) have~     been rarely evaluated in patient treated with DES. This multicentre, prospective registry was~     aimed to evaluate influence of physiologic parameters on the clinical outcome after DES~     implantation.~   "
129669|NCT01870102|"~     Part 1 : A randomized, open Label, multiple doses, cross-over, phase I trial to investigate~     the pharmacokinetics of Pelubiprofen IR (Pelubiprofen 30mg) TID and Pelubiprofen SR~     (Pelubiprofen 45 mg) BID in healthy male volunteers Part 2 : A randomized, open label, single~     dose, cross-over, Phase I trial to investigate the food effect of Pelubiprofen SR~     (Pelubiprofen 45 mg) in healthy male volunteers~   "
129406|NCT01873547|"~     The morbidity of spinal cord injury (SCI) is increasing year by year significantly in China.~     The methods to treat SCI patients in sequela stage update are poor. Though traditional~     rehabilitation therapy is the routine method to treat SCI in sequela stage, aiming to improve~     the neurological disorders of these patients, such as sensory disturbance, dyskinesia,~     autologous adjustment of blood pressure, dysfunction of urination, defecation and~     perspiration , etc. What's a pity, the efficacy of the rehabilitation therapy is~     unsatisfactory. Rehabilitation Therapy can prevent the process of muscle atrophy and joint~     stiffness. However, it can not repair the damaged nerve function. Studies show that~     mesenchymal stem cell transplantation can remarkably improve the neurological function of SCI~     in animals without any severe side effect.~      In this study, 300 patients will be divided into three groups and the investigators will use~     mesenchymal stem cells derived from umbilical cord to treat 100 SCI patients. They will also~     follow up 100 patients who only receive rehabilitation and another 100 patients who accept~     neither stem cell therapy nor rehabilitation. On this basis, the investigators can compare~     the efficacy of these two treatments.~   "
129407|NCT01873534|"~     The trial is an uncontrolled, open-label, parallel group clinical trial. Approximately 10~     subjects per dose group in 3 groups will be treated twice weekly for a total of 9 doses,~     followed by a 4-week observation period. Eligible subjects who have Hgb ≥10.5 g/dL and have~     stable Hgb levels will start the washout period of one to eight weeks. During the washout~     period, 30 subjects whose Hgb are < 10.0 will complete the baseline assessment to confirm~     their eligibility. Eligible subjects will be randomly assigned to one of the 3 cohorts in a~     1:1:1 ratio. Subjects will be admitted on the day of the first dose and stay in the clinic~     overnight for pharmacokinetic (PK) sampling after the first (day 1) and the last dose (day~     29). FMX-8 will be administered as 30 min i.v. infusion. After the 29-day treatment period,~     the trial subjects will be observed for an additional 28 days to allow safety and~     immunogenicity assessments.~   "
129408|NCT01873521|"~     It is hypothesized that the use of Neurally Adjusted Ventilatory Assist (NAVA) compared to~     pressure support to provide noninvasive ventilation to children will result in a decrease in~     the number of children with moderate to severe respiratory failure failing noninvasive~     ventilation and requiring endotracheal intubation. It is further hypothesized that~     noninvasive ventilation with NAVA compared to pressure support will result in a decrease in~     the length of mechanical ventilation, and the length of PICU and hospital stay.~   "
129409|NCT01873508|"~     This single-center, open label, randomized, 3-period cross-over study will compare 3~     modified-release formulations of RO4917523 in healthy volunteers. Subjects will be randomized~     to one of six sequences to receive single oral doses of RO4917523 slow, target and fast~     release modified release (MR) capsules along with a reference intravenous microdose with the~     target capsule. A washout period of at least 21 days will occur between treatments.~   "
129410|NCT01873495|"~     The purpose of this pilot study is to assess the safety and tolerability of omacetaxine for~     consolidation in patients age 55 and older with acute myelogenous leukemia (AML) in first~     complete remission following induction with cytarabine and an anthracycline, and also to~     assess the safety and tolerability of omacetaxine for maintenance in patients age 55 and~     older with acute AML in first complete remission following 3 consolidation courses with~     omacetaxine.~   "
129411|NCT01873482|"~     Pre-agricultural societies almost universally used healing ceremonies that involved~     reverence, rhythm and dance in the presence of a healer. It is believed that we are wired~     for such experiences and they foster an integrative mode of consciousness similar to that of~     mindfulness based stress reduction, which has been shown to have therapeutic effects in a~     variety of conditions. Collaborator Ava Lavonne Vinesett of the Duke Dance Program has~     developed a healing ceremony based in sub-Saharan African traditions. The investigators plan~     is to have 25 subjects with a variety of clinical conditions participate in this ceremony.~     Subjects will then be asked to write a commentary about their experience and to participate~     in a focus group discussion. It is anticipated that the study will give us some idea of how~     promising this approach would be and what kinds of patients might benefit. Safety issues are~     minimal and include the possibility of injury (though the dancing is not strenuous) and~     psychological distress.~   "
129412|NCT01873469|"~     Local recurrence is a major problem of clinical treatment of glioblastoma multiforme (GBM).~     Today a very sensitive imaging method to detect glioblastoma is [11C]MET Positron emission~     tomography (PET), where in some patients also tumour manifestations can be detected that are~     not visible in MRI investigations.~      The aim of the study is to investigate the association of high [11C]MET tracer uptake before~     postoperative radiochemotherapy and concurrent temozolomide (TMZ) with time to recurrence in~     patients with glioblastoma multiforme. Also site of recurrence will be correlated with the~     [11C]MET imaging before and early during radiochemotherapy. All imaging information will be~     included in treatment planning or treatment decisions.~      The study provides a basis for later radiation dose escalation trials on the base of [11C]MET~     imaging.~   "
129413|NCT01873456|"~     The hypothesis is that there is a profit potential by implementing a multifactorial~     nutritional intervention among frail elderly since this will result in an improved~     nutritional status, functional capacity and improved quality of life.~   "
129414|NCT01873443|"~     This is an open-label, single-arm, multicenter, efficacy, and safety maintenance study of the~     Phase 1 Study CT-P10 1.1. This study is designed to assess the long-term efficacy and safety~     of CT-P10 co-administered with MTX and folic acid in patients with RA who have completed the~     scheduled visits in Study CT-P10 1.1~   "
129415|NCT01873430|"~     The aim of this study is to investigate the sun protective effect of melatonin, when used as~     a cream applied before sun exposure.~      Sun exposure induces erythema as indication of an inflammatory reaction in the skin. It is~     proven that the amount of free radicals in the skin are increased by UV exposure.~     Furthermore, it is known that melatonin is a potent antioxidant. It is hypothesized that~     melatonin can be protective against the UV induced release of free radicals by acting as a~     radical scavenger and thereby protect against UV-induced cellular damage.~   "
129788|NCT01868542|"~     This trial is conducted in Asia. The aim of the trial is to compare the glycaemic control of~     Levemir® (insulin detemir) administered once daily according to two titration algorithms~     after 20 weeks in subjects with type 2 diabetes inadequately controlled on metformin~     treatment with or without other anti-diabetic drugs (OADs).~   "
129416|NCT01873417|"~     The primary objective of this study is to evaluate the effect of symptomatic therapies on~     gastrointestinal (GI)-related events reported by participants with relapsing forms of~     multiple sclerosis (MS) initiating therapy with dimethyl fumarate (DMF) in the clinical~     practice setting.~      The secondary objectives of this study are as follows:~        -  To evaluate GI-related events requiring symptomatic therapy and the role of those~          therapies over time in participants with relapsing forms of MS initiating therapy with~          DMF in the clinical practice setting.~        -  To evaluate GI-related events that lead to DMF discontinuation after the use of~          symptomatic therapy in participants with relapsing forms of MS initiating therapy with~          DMF in the clinical practice setting.~   "
129417|NCT01873404|"~     The primary objective of the study is to assess the efficacy of Intravenous (IV) BG00010~     (Neublastin) in improving pain in painful lumbar radiculopathy participants when administered~     3 times per week for 1 week.~      The secondary objectives of this study in this study population are as follows: To explore~     the duration of the effect of BG00010 in improving pain; To explore the dose response curve~     on pain reduction; To assess the safety and tolerability of BG00010; To assess the serum~     exposure to BG00010.~   "
129418|NCT01873391|"~     The objective of this study is to assess which factors influence the pain perceived during~     diagnostic anesthesia-free hysteroscopy.~   "
129419|NCT01873378|"~     The primary outcome of this study is to assess if the GnRHa administration before cold loop~     hysteroscopic myomectomy contributes to accomplish the treatment in only one surgical~     procedure. Moreover, we will investigate the intraoperative influence of such pharmacologic~     therapy in terms of distension liquid absorption and duration of the procedures.~   "
129420|NCT01873365|"~     The study aims to estimate the incidence of herpes zoster (HZ), proportion of postherpetic~     neuralgia (PHN) and the economic burden and impact on quality of life, in Japanese adults~     greater than or equal to sixty years of age.~   "
129421|NCT01873352|"~     The objective of this trial is to determine the role of renal sympathetic denervation in the~     prevention of atrial fibrillation (AF) recurrence in patients with hypertension for whom a~     catheter-based AF ablation procedure is planned. Patients will be randomized to either AF~     catheter ablation (usual therapy) or AF catheter ablation plus renal sympathetic denervation.~   "
129422|NCT01873339|"~     This study will determine the effect of single and repeat administration of darapladib, a~     novel, selective, orally active inhibitor of lipoprotein associated phospholipase A2~     (Lp-PLA2) currently under clinical development on the pharmacokinetics of a single oral dose~     of midazolam, a cytochrome P450 3A4 (CYP3A4) probe substrate. This study will investigate the~     inductive and inhibitory effect of darapladib on CYP3A4 metabolic pathway.~   "
129423|NCT01873326|"~     The purpose of this study is to learn about the safety and effectiveness of two different~     drug combinations in patients who have intermediate- and poor-risk germ cell tumors (GCT).~     One combination of drugs, paclitaxel, ifosfamide and cisplatin (TIP), is experimental. The~     other combination of drugs, bleomycin, etoposide and cisplatin (BEP), is the standard of care~     treatment for intermediate- and poor-risk germ cell tumors. However, BEP does not cure every~     patient and therefore newer treatments are needed.~   "
129424|NCT01873313|"~     The primary goal is to evaluate ropivacaine blood concentrations during and after local~     anaesthetic (ropivacaine) infiltration - the Caledonian technique - for total knee~     replacement surgery. The investigators plan to measure these levels by testing blood samples~     taken over a timed period.~      This will allow us to confirm whether the current regimen of local anaesthetic use is within~     safe limits.~   "
129425|NCT01873300|"~     Endoscopic Esophageal Myotomy (POEM), the research procedure, splits the lower esophageal~     sphincter muscle fibers from the inside of the esophagus, avoiding several abdominal~     incisions (belly area cuts), by using an endoscope to create a small cut at the most inner~     layer of the esophagus to expose the esophageal sphincter muscle fibers from the inside of~     the esophagus. The investigators are studying whether subjects who undergo Endoscopic~     Esophageal Myotomy will have similar functional outcome, and at the same time less pain, scar~     formation and wound infection than with laparoscopic or open surgery.~   "
129426|NCT01873287|"~     Concussion, a mild traumatic injury common in children and adolescents, is a complex~     pathophysiological process affecting the brain. The lay press is inundated with reports of~     tragic consequences of concussion, and children are not immune.~      Persistent postconcussive symptoms (PCS) is defined as the persistence of somatic, cognitive,~     physical, psychological or behavioural changes lasting more than one month following injury.~     PCS significantly impacts children and their family's quality of life through school~     absenteeism, depressed mood and loss of activities.~      Validated, easy-to-use prognosticators do not exist for clinicians to identify children at~     highest risk for PCS. As a result,physicians cannot accurately inform children and parents~     whether they should expect longer symptoms, nor initiate pharmacotherapy or other management~     to reduce the occurrence or severity of PCS.~      The investigators objective is to derive and validate a clinical prediction rule for the~     development of PCS in children and adolescents presenting to the emergency department (ED)~     following acute head injury. The investigators have three aims: (1) determine PCS incidence~     at one-month follow-up in children aged 5-17 who sustain a concussion; (2) derive a rule to~     predict PCS from variables present in the history and physical examination; and, (3) assess~     the accuracy, reliability and acceptability of the prediction rule in a subsequent cohort.~     Using a prospective, multicentre study at nine large Canadian pediatric EDs, the~     investigators will recruit the largest prospective epidemiological cohort of children with~     concussions in the literature.~      This work will provide rigorous evidence to determine PCS incidence in children and its~     impact on quality of life. The results will enable clinicians to identify children at highest~     risk for PCS, optimize treatment and provide families with realistic anticipatory guidance.~     This study will also establish a strong and vital evidence base to advance concussion~     research.~   "
129427|NCT01873274|"~     The objective of this study is to investigate the absorption of menaquinone-7 from a~     nutrient-enriched dairy product compared to a general dairy product enriched with~     menaquinone-7 and a menaquinone-7-containing supplement.~   "
129428|NCT01873261|"~     This pilot study will be an observational no randomize study in which the NiNAVAped protocol~     will be applied solely to the NIV NAVA arm.~   "
129429|NCT01873248|"~     This is a prospective, Phase 1-2, single center study in a total of 100 subjects with~     Neuroendocrine Tumors (NETs). Study participants will receive a one-time administration of~     68Ga-DOTATATE and undergo a PET/CT imaging study, to investigate its suitability as a PET~     imaging agent for NETs.~   "
129789|NCT01868529|"~     This trial was conducted in Europe. The aim of this trial was to compare the pharmacodynamic~     (the effect of the investigated drug on the body) response of insulin degludec (insulin 454)~     with insulin glargine at steady-state conditions in subjects with type 1 diabetes mellitus.~   "
129430|NCT01873235|"~     Advances in our understanding of the pathogenesis of autosomal dominant polycystic kidney~     disease (ADPKD) have opened up possibilities of new therapies to prevent disease progression.~     High quality clinical investigations in patients with ADPKD, however, pose significant~     challenges to investigators including limited access to patients with ADPKD,insufficient~     guidance by experienced investigators and lack of resources to conduct these studies.~      The Polycystic Kidney Disease Research Clinical and Translational Core (P30) aims to~     establish an infrastructure that will assist investigators in designing and conducting~     highest quality clinical and translational research focused on a diverse group of patients~     with ADPKD.~      Objective 1: To establish a Mid-Atlantic cohort of ADPKD patients (N=200) with baseline~     clinical phenotyping performed at the General Clinical Research Unit of the University of~     Maryland School of Medicine.~      Objective 2: To establish a state-of-the-art biobank of specimens from the ADPKD cohort~     including serum, plasma,urine and DNA.~      Objective 3: To develop a collaborative network of physicians and practices in the~     Mid-Atlantic region who will contribute to the ADPKD cohort and will be willing to refer~     patients for future studies and trials.~      Objective 4: To establish a web-based registry of ADPKD patients in the Mid-Atlantic area.~   "
129431|NCT01873222|"~     This study is the sub-study of OPINION Trial. (UMIN000010580) The aim of this study is to~     evaluate how Optical frequency domain imaging (OFDI) or Intravascular Ultrasound (IVUS)~     imaging technology influence to the Percutaneous Coronary Intervention (PCI) strategy.~   "
129432|NCT01873196|"~     This research will test alternative methods of ensuring compliance with recommended~     preparation and targeting of supplementary foods for malnourished children under five years~     of age.~      The hypotheses that the proposed study intends to test are as follows:~        1. With appropriate behavior change communication (BCC) and social support, and with~          provision of CSB and FVO in the correct proportions, it is possible to get women to~          prepare CSB with oil in the recommended ratio of 100:30, and in quantities just~          sufficient for the target child.~        2. Providing CSB to Beneficiary Mothers/Caretakers pre-packaged bags of 2 kg with~          appropriate messaging and with instructions to direct the food to children and to~          prepare the CSB with oil in the recommended ratio and feed as instructed will result in~          better compliance.~   "
129433|NCT01873183|"~     In bariatric surgery functional and feasible non- or mini-invasive modalities for monitoring,~     and ideal/lean body weight estimates are addressed to meet up individual variability in~     hydration needs, and to avoid hyperhydration.~      The aim of the study is to evaluate need of perioperative hydration by comparing conventional~     monitoring (the control group) to a more advanced approach (individualized goal-directed~     therapy, IGDT) (the intervention group). In addition to conventional cardiovascular~     monitoring (ECG, non-invasive blood pressure, Sp02) preoperative transthoracic~     echocardiography (TTE) and a intraoperative perioperative mini-invasive pulse-contour device~     (FloTrac™) will be used for the purpose.~   "
129434|NCT01873170|"~     This study is being done to understand if using birth control causes changes in the immune~     cells within the reproductive tract (including the cervix and the lining of the uterus) of~     healthy women. Immune cells are important because they help prevent infections from starting~     and help fight infections that have started. Immune cells are also the type of cells that HIV~     (human immunodeficiency virus) infects so understanding more about them will help to better~     understand how to prevent the spread of HIV.~      Immune cells will be studied from the reproductive tract of women who want to start using one~     of the following contraceptives: an oral contraceptive pill (COC), Depo-Provera (DMPA), the~     levonorgestrel IUD (Mirena®), the copper IUD (ParaGard®), or the etonogestrel subdermal~     implant (Nexplanon®).Immune cells will also be studied from the reproductive tract of women~     who are not using birth control and who are not at risk of pregnancy for comparison.~   "
129435|NCT01873157|"~     Late antibody-mediated rejection (AMR) after kidney transplantation is defined as a separate~     rejection entity. So far, no appropriate treatment has been established for this rejection~     type. One promising strategy could be the targeting of alloantibody-producing plasma cells.~     There is now accumulating evidence that the proteasome inhibitor Bortezomib may substantially~     affect the function and integrity of non-malignant alloantibody-secreting plasma cells. The~     impact of this compound on the course of late AMR , however, has not yet been systematically~     investigated. In the planned phase IIa study we will examine the effect of Bortezomib on late~     AMR after kidney transplantation. We plan an initial cross-sectional HLA antibody screening~     of 1000 kidney transplant recipients to identify patients with detectable donor-specific~     antibodies (DSA). DSA-positive recipients will be subjected to kidney allograft biopsy to~     detect morphological features consistent with AMR. Forty-four patients with late AMR will be~     included in a randomized double-blind placebo-controlled parallel-group intervention trial.~     Patients in the active group will receive two cycles of Bortezomib (4 x 1.3 mg/m2). The~     primary end point will be the course of estimated GFR over 24 months after randomization.~     Secondary endpoints are the course of DSA levels and protein excretion, measured GFR after 24~     months, transplant and patient survival, and the development of acute and chronic~     morphological lesions in 24-month protocol biopsies. Our study will clarify the impact of an~     innovative anti-humoral strategy on the deleterious effects of late AMR processes.~   "
129436|NCT01873144|"~     The purpose of this study is to demonstrate that heated, humidified, high-flow nasal cannula~     (HHHFNC) is superior to hypertonic saline solution (HSS) in the treatment of moderate acute~     viral bronchiolitis in infants in improving respiratory distress and comfort and reducing~     length of hospital stay (LOS) and admission to Pediatric Intensive Care Unit (PICU).~   "
129443|NCT01873053|"~     This trial is a multi-center, randomized, double-blind, placebo-controlled, parallel, phase~     II clinical trial and aimed at osteoarthritis of the knee.~      Patients who signed informed consent voluntarily and eligible for this study are assigned~     randomly to one of 3 groups after 2 week-Washout period.~        1. st group (experimental) : WIN-34B 450mg BID~        2. nd group (experimental) : WIN-34B 900mg BID~        3. rd group (Comparator) : Placebo BID~      Patients will take WIN-34B or Placebo BID for 12 weeks. Based on baseline, after 4~     weeks(Visit 3) and 12 weeks(Visit 5), Researchers check patients' physical examination,~     questionnaire, laboratory experiment.~      After 8 weeks(Visit 4), researchers check adverse effects and current medication status via~     telephone interview.~      After 12 weeks(Visit 5) patients stop taking drugs and after 16 weeks(Visit 6) researchers~     check patients' physical examination, questionnaire, adverse effects and current medication~     status.~   "
129437|NCT01873131|"~     The purpose of this study is to find out if pulsed dye laser treatment or timolol maleate~     0.5% gel can help infants who have a hemangioma. The investigators also want to find out if~     pulsed dye laser treatment and timolol maleate 0.5% gel are safe to use without causing too~     many side effects.~      Hemangioma is a common type of birthmark. These birthmarks happen when many new blood vessels~     grow in a specific area on the skin. Blood vessels are tiny tubes that carry blood through~     the body. No one knows what causes blood vessels to group together. Most birthmarks don't~     hurt at all and they usually aren't a sign of any kind of illness. Lots of newborns have~     these birthmarks on their bodies, like between the eyebrows. These birthmarks usually~     disappear within the first few months to years of life. These birthmarks tend to disappear~     spontaneously. Most hemangiomas are not treated unless the hemangioma threatens the child's~     health, which occurs in about 1 in 3 children with hemagiomas.~      Pulsed dye laser is widely used in children, and is approved by the U.S. Food and Drug~     Administration (FDA) for treating hemangioma.~      The FDA has approved timolol maleate to treat glaucoma in adults, but the FDA has not~     approved timolol maleate to treat hemangiomas in children. About 7 infants with hemangiomas~     have received timolol maleate. The results so far show that timolol maleate may be helpful~     and safe in treating hemangiomas in infants.~      An important question being tested in this study is whether pulsed-dye laser or timolol~     maleate can prevent hemangioma from growing when used very early after birth.~   "
129438|NCT01873118|"~     Preparation of patients for discharge is a primary function of hospital-based nursing care~     and readiness for discharge is an important outcome of hospital care. Inadequacies in~     discharge preparation have been well-documented and linked to difficulty with self-management~     after hospital discharge and with increased likelihood of emergency department (ED) use and~     readmission. Prior studies by the research team have led to recommendations for~     implementation of discharge readiness assessment as a standard nursing practice for hospital~     discharge.~      The investigators will conduct a multi-site study to determine the impact on post-discharge~     utilization (readmission and ED visits) and costs of implementing discharge readiness~     assessment as a standard nursing practice for adult medical-surgical patients discharged to~     home. The study tests, in a stepped approach, the impact of implementing discharge readiness~     assessment by the discharging nurse as standard nursing practice (RN-RHDS protocol), the~     incremental value of informing the nurse assessment with the patient's perspective~     (RN-RHDS+PT-RHDS protocol), and of requiring that the nurse initiates and documents~     risk-mitigating actions for patients with low readiness scores (RN-RHDS+PT-RHDS+NIAF~     protocol).~      HYPOTHESIS 1: Patients discharged using the RN-RHDS protocol will have fewer hospital~     readmissions and ED visits within 30 days post-discharge compared to patients discharged~     under usual care conditions.~      HYPOTHESIS 2: Patients discharged using the RN-RHDS+PT-RHDS protocol will have fewer hospital~     readmissions and ED visits within 30 days post-discharge compared to patients discharged~     using the RN-RHDS protocol.~      HYPOTHESIS 3: Patients discharged by nurses using the RN-RHDS+PT-RHDS protocol plus a~     Nurse-Initiated Action Form [NIAF] (RN-RHDS+PT-RHDS+NIAF protocol) will have fewer~     post-discharge readmissions and ED visits than patients discharged using the RN-RHDS+PT-RHDS~     protocol; the effect will be strongest for patients with low RHDS scores.~      Aim 4: Conduct cost-benefit analysis of implementing discharge readiness assessment as~     standard practice, by comparing cost-savings from reduced post-discharge utilization against~     implementation costs.~   "
129439|NCT01873105|"~     The purpose of this study is to improve the experience of discharge of adult medical surgical~     patients through improved discharge preparation communication between patients and care team~     members, with subsequent improvement in the post-discharge experience. Obtaining multiple~     perspectives on discharge readiness creates the opportunity for patient and care team to~     partner in identifying deficiencies in discharge readiness that warrant anticipatory,~     compensatory, or corrective interventions prior to discharge, with the goal of averting~     post-discharge problems and utilization. The results will also inform development and~     translation of tools for assessment of discharge readiness to clinical care environments.~      Specific Aims are to:~        1. Describe patterns of communication about discharge and collaboration among members of~          the health care team~        2. Conduct psychometric testing of 3 forms of the Readiness for Hospital Discharge Scale~          (RHDS - MD, RN, Patient)~        3. Describe relationships between care team communication, patient perceptions of quality~          of discharge preparation and perceived readiness for discharge, care team (RN and MD)~          assessments of discharge readiness, and post-discharge outcome ( post-discharge coping~          difficulty, Emergency Department (ED) use, and 30 day readmission.~        4. Determine the impact of an intervention with the inpatient care team to improve~          discharge preparation communication.~      H1: Patient perceptions of discharge readiness, post-discharge coping difficulty, ED use and~     readmission will improve following a care team educational intervention about discharge~     preparation, compared to pre-intervention baseline measures.~      H2: Care team members will report improved frequency and amount of discharge preparation~     communication following a care team educational intervention about discharge preparation,~     compared to pre-intervention baseline measures.~      H3: RN-MD collaboration will increase following a care team educational intervention about~     discharge preparation, compared to pre-intervention baseline measures~   "
129440|NCT01873092|"~     Chronic obstructive lung disease (COPD) is characterized by airflow obstruction that is~     progressive over many years and is largely irreversible. Advanced COPD is associated with~     arterial oxygen desaturation leading to a series of complications and, ultimately, decreased~     survival. Long-term oxygen therapy can improve clinical outcomes in these patients, but the~     exact target of oxygen saturation that actually translates into improvements is not known.~     The basis for the work in this proposal is to focus a new approach to measure oxygen~     desaturation linked to daily activity. Accelerometers are used to measure daily activity and~     then synchronized with ambulatory oximetry to establish an activity/oxygen-saturation profile~     for individual patients. The three main objectives of this study are 1) determine the~     feasibility of AOM as a measurement of the temporal profile of oxygen saturation in patients~     with chronic lung disease; 2) determine if serial AOM-derived data is reliable and~     reproducible; and 3) determine thresholds of oxygen desaturation that are associated with~     different activity profiles~   "
129441|NCT01873079|"~     Endoscopic biliary sphincterotomy is a common and important procedure for biliary access and~     therapy during endoscopic retrograde cholangiopancreatography (ERCP). Bleeding is one of the~     important complications related to sphincterotomy. This study determines the role of proton~     pump inhibitor (PPI) in preventing post-sphincterotomy bleeding in patients undergoing ERCP~     and sphincterotomy.~   "
129442|NCT01873066|"~     Type 1 diabetes (T1D) is one of the most common chronic childhood diseases requiring lifelong~     insulin therapy. Children and adolescents with T1D need regular insulin injections or the~     continuous insulin delivery using an insulin pump in order to keep blood glucose levels~     normal. We know that keeping blood sugars in the normal range will help prevent long-term~     diabetes-related complications involving the eyes, kidneys and heart. However, achieving~     treatment goals can be very difficult particularly due to the risk of low glucose levels~     (hypoglycaemia). One solution is to use a system where the amount of insulin injected closely~     matches the blood sugar levels on a continuous basis. This can be achieved by what is known~     as a closed-loop system where a small glucose sensor placed under the skin communicates~     with a computer containing an algorithm that drives a subcutaneous insulin pump. We have been~     testing such a system in Cambridge over the last five years in children and have found that~     this system is effective, and superior to usual insulin pump therapy, at maintaining tight~     glucose control. More recently the system has been tested overnight, in the home setting, for~     three weeks in adolescents during a pilot single-centre study.~      The next step is to evaluate use of the closed loop system day and night over a period of 7~     days (phase 1) and 21 days (phase 2) in adolescents with type 1 diabetes. In the present~     study we are planning to study 24 (12 phase 1 ans 12 phase 2) young people aged 10-18 years~     on insulin pump therapy. This study will involve two 7 (phase 1) and 21 (phase 2) day home~     study periods, during which glucose levels will be controlled either by an automated~     closed-loop system or by subjects usual insulin pump therapy combined with continuous glucose~     monitoring alone in random order. Prior to the closed-loop study period, there will be a~     training period in the clinical research facility, which will allow participants to~     familiarise themselves with the closed-loop system before going home.~      We aim to to determine the effect of the closed-loop computer algorithm in keeping glucose~     levels between 3.9 and 10.0 mmol/L during the daytime and overnight.~   "
129493|NCT01872403|"~     Albumin-bound paclitaxel plus carboplatin regimen in advanced NSCLC especially in lung~     squamous cell carcinoma has a better tumor response rate and safety, therefore.The main~     purpose of this study is to observe the safety and efficacy of albumin-bound paclitaxel /~     carboplatin in the treatment of lung squamous cell carcinoma of stage IIB and IIIA.~   "
129444|NCT01873040|"~     This study will assess the effectiveness of social media website devoted to vaccines to~     change immunization knowledge, perceptions and behavior. If effective, this intervention will~     represent an innovative, low cost and broadly applicable resource to reduce parental~     vaccination concerns.~      The study has two hypothesis:~        1. Parents receiving usual care plus social media website will demonstrate higher early~          childhood immunization rates to parents receiving either usual plus non interactive~          website or usual care only.~        2. Parents receiving usual care plus social media website will demonstrate positive changes~          in knowledge, attitudes and beliefs supporting vaccination compared to parents receiving~          either usual care plus non-interactive website or usual care only.~   "
129445|NCT01873027|"~     The aim of this randomized study is to evaluate the impact of Optical frequency domain~     imaging (OFDI) guidance for Percutaneous Coronay Intervention (PCI) with drug-eluting stent~     (DES) as compared with Intravascular ultrasound (IVUS) guidance.~   "
129446|NCT01873014|"~     safe study of Chinese Herbs to Treat Thyroid Diseases With Different Iodine~   "
129447|NCT01873001|"~     The purpose of this study is to evaluate the effects of abiraterone on the pharmacokinetics~     (study of what the body does to a drug) of pioglitazone when coadministered with abiraterone~     acetate in healthy adult male participants.~   "
129448|NCT01872988|"~     Hepatocellular carcinoma (HCC) is one of the most common solid cancers worldwide, and chronic~     hepatitis B virus (HBV) infection is the most common etiology of HCC in Asia. Transarterial~     chemoembolization (TACE) is the standard treatment for patients with unresectable HCC in the~     BCLC intermediate stage, but the HCC recurrence rates and long-term mortality rates are quite~     high. These intermediate-staged HCC patients usually need repeated TACE due to tumor~     recurrence, and they may die of HCC progression or liver decompensation after repeated TACE.~     Improved liver function and decreased liver disease progression due to oral antiviral therapy~     have been proven to be effective for chronic hepatitis B, and oral antiviral therapy may keep~     better liver reserve and provide better chance for HCC patients received TACE. In addition,~     chronic HBV infection is one of the most important factors for HCC development, and antiviral~     therapy can improve the outcomes after curative treatment. However, the evidence of improving~     outcomes of HCC patients underwent TACE by oral antiviral therapy is lacking. Moreover,~     Tenofovir Disoproxil Fumarate (TDF) is one of the most potent oral antiviral agents, and its~     safety and very low long-term viral resistance rate have been also reported. There is no~     study to evaluate the impacts of TDF for HBV-related HCC patients underwent TACE. Until now,~     routine antiviral therapy for HBV-related HCC patients underwent TACE has still not been~     recommended by current guidelines. The hypothesis of this study is that a potent oral~     antiviral therapy for patients with HBV-related HCC patients receiving TACE improve patients'~     outcomes~   "
129449|NCT01872975|"~     This randomized phase III trial studies standard or comprehensive radiation therapy in~     treating patients with early-stage breast cancer who have undergone surgery. Radiation~     therapy uses high-energy x rays to kill tumor cells. It is not yet known whether~     comprehensive radiation therapy is more effective than standard radiation therapy in treating~     patients with breast cancer~   "
129450|NCT01872962|"~     The purpose of this study is to compare induction chemotherapy (gemcitabine+cisplatin) plus~     concurrent chemoradiotherapy (CCRT) with CCRT alone in patients with locoregionally advanced~     nasopharyngeal carcinoma(NPC), in order to confirm the value of induction chemotherapy in NPC~     patients.~   "
129451|NCT01872949|"~     The study is designed to observe the clinical outcomes of heart failure patients treated with~     C-Pulse® System in the usual manner and according to the approved indications and~     contraindications.~   "
129452|NCT01872936|"~     The purpose of this open-label study is to assess the safety, tolerability, antiviral~     activity, genotype resistance associated with virological failure, pharmacokinetics and~     pharmacodynamics of two dose regimens of miravirsen in combination with telaprevir and~     ribavirin in subjects with hepatitis C virus genotype 1 infection who are null responder to~     pegylated-interferon alpha and ribavirin.~   "
129453|NCT01872923|"~     The primary goal of this extension study is to further investigate the tolerability and~     efficacy in a phase I setting in order to see whether lower doses than the initial study dose~     of 0.25 mg/kg bw Amphinex in Amphinex-based PCI of bleomycin will show a comparable or~     improved safety and tolerability profile in combination with comparable signs of efficacy.~   "
129454|NCT01872910|"~     The main purpose of this study is to test if a single dose of LY3023703 relieves pain after~     wisdom teeth removal. The study will last about one week for each participant, not including~     screening.~   "
129455|NCT01872897|"~     This study is being conducted to assess the effectiveness of the Compound Sodium Alginate~     Double Action Chewable Tablets compared to placebo on acidic reflux events into the esophagus~     in patients diagnosed with Gastroesophageal Reflux Disease (GERD).~   "
129456|NCT01872884|"~     The purpose of this study is to evaluate whether general anesthesia or sedation technique is~     preferable during embolectomy for stroke, measured in terms of three months neurological~     impairment. In addition we study if there is any difference between the methods regarding~     complication frequency.~   "
129457|NCT01872871|"~     Retinopathy of prematurity (ROP) is one of the major morbidity among preterm infants.~     Although, local anesthetics reduce pain to some extent, eye examination still remains as a~     painful procedure. The investigators aimed to evaluate the effect of oral paracetamol~     combined with local anesthetics for pain relief during ophthalmological examination.~   "
129458|NCT01872858|"~     Patients of vascular cognitive impairment-no dementia (VCIND) in one group is prescribed~     cilostazol,in the other group is prescribed aspirin. Evaluate both of them in cognitive~     function, MRI and other sides at given time. The investigators hypothesize that cilostazol is~     more efficient and safer than aspirin in patients with VCIND.~   "
129513|NCT01872143|"~     The purpose of this study is to determine whether transcranial direct current stimulation~     (tDCS) is effective in the treatment of psychiatric disorders in which available treatments~     are either ineffective or not tolerated~   "
129790|NCT01868516|"~     Overactive bladder (OAB) is a syndrome characterized by symptoms of a sudden need to urinate~     with or without incontinence (leaking). The purpose of this study is to test whether~     dexmecamylamine is safe and effective compared to placebo for the treatment of symptoms of~     OAB.~   "
129459|NCT01872845|"~     Current consensus papers recommend statin medication to reduce Low density lipoprotein (LDL)~     cholesterol level less than 100mg/dL (optional 70mg/dL) in patients with coronary artery~     disease. However, there is lack of solid evidence whether a specific kind of statin have the~     superiority against other statins in clinical outcomes. Furthermore, recent data have showed~     that several kinds of statin could have an adverse effect on glucose metabolism and increase~     the risk of development of diabetes. Carotid Intimamedia thickness (CIMT) is a surrogate~     marker of atherosclerosis to predict long term cardiovascular outcomes in not only general~     population but also patients with established coronary artery disease. Consequently, we will~     evaluate the efficacy of high dose of pravastatin on CIMT, comparing with moderate dose of~     rosuvastatin in patients with established coronary artery disease. Additionally, we will~     assess the clinical outcomes of pravastatin after percutaneous coronary intervention as well~     as adverse outcomes including insulin resistance and new onset diabetes compared with~     rosuvastatin. Our main hypothesis is that pravastatin 40mg would be non-inferior to~     rosuvastatin 20mg regarding CIMT at 1 year follow up.~   "
129460|NCT01872832|"~     This study will explore the safety, tolerability, and serum uric acid lowering effect of~     RDEA3170 in healthy Japanese males to allow comparison with the Western population.~   "
129461|NCT01872819|"~     This clinical trial uses a laboratory test called a high throughput sensitivity assay in~     planning treatment for patients with relapsed or refractory acute myeloid leukemia. The aim~     is to try to identify drugs that may be effective in killing leukemia cells for those~     patients who will not be cured with conventional chemotherapy. This assay will test multiple~     drugs simultaneously against a patient's own donated blood sample. The goal is to use this~     laboratory assay to best match a drug to a patient's disease.~   "
129462|NCT01872806|"~     The main objective of this study is to investigate whether radiofrequency electromagnetic~     radiation, induced by a dialing mobile phone placed on the body, causes a change in~     electrophysiology.~   "
129463|NCT01872793|"~     Despite the importance of nutritional status in patient's outcome, there is no gold standard~     for nutritional assessment. Traditional techniques used in healthy subjects to assess~     nutritional status cannot be used in cirrhotic patients due especially to ascites and~     peripheral edema, and altered rates of biochemical markers due to liver failure.~      Bioelectrical impedance vector analysis has emerged as a useful method to assess body~     composition and nutritional status especially in patients at the extremes of body weight~     (fluid overload, excess of adipose tissue, etc.).~      With previous results from our research group, BIVA showed to be useful for evaluating~     cirrhotic patients.~      The aim of this study is to validate our previous results and validate BIVA for nutritional~     assessment in patients with liver cirrhosis~   "
129464|NCT01872780|"~     The genotype profile of CYP2C8 was analyzed in a Korean population. Frequency in multi-ethnic~     population and in vivo functionality of novel null allelic CYP2C8 variant were evaluated.~   "
129465|NCT01872767|"~     After successful screening diagnosis of cirrhosis and/or acute or chronic liver failure will~     be made. These patients will undergo detail clinical, biochemical and microbiological~     examination at baseline. Clinical examination and Biochemical evaluation will be done daily~     and signs of infection will be noted. Patients will undergo microbiological screening for~     infection every 48 hours. Patients suspected or diagnosed to be suffering from infections~     will be treated as per ILBS (Institute of Liver and Biliary Sciences) antibiotic policy. Site~     and etiology (bacterial and/or fungal) of infections will be noted in all patients at~     admission in liver specialty ICU (Intensive Care Unit) and during the ICU (Intensive Care~     Unit) stay. All the patients will be followed until discharge or death in ICU (Intensive Care~     Unit).~   "
129466|NCT01872754|"~     The purpose of this study is to determine whether the use of Target-Controlled Infusion (TCI)~     of Remifentanil can deliver better conditions for performing bronchial fibroscopy with~     spontaneous ventilation (decrease the duration of cough) compared to the use of TCI of~     Propofol.~   "
129467|NCT01872741|"~     This randomized prospective study was designed to compare the clinical, functional and~     aesthetic results of two surgical techniques for microsurgical clipping of anterior~     circulation aneurysms~   "
129468|NCT01872728|"~     A bilateral facial block (infraorbital and infratrochlear) will be performed immediately~     after intubation in patients undergoing outpatient rhinoplasty with 2.5% levobupivacaine~     (intervention group) or saline as control. Intravenous saline or morphine will be~     administered at the end of surgery in intervention or control groups, respectively. In case~     of pain in post-anesthesia care unit (numerical pain score >3 on a 0-10 scale), both groups~     will receive intravenous morphine titration. The total perioperative morphine consumption~     (intraoperative and in post-anesthesia care unit) will be compared between groups. Pain~     intensity, presence of nausea/vomiting and patient's satisfaction will be compared between~     groups.~   "
129469|NCT01872715|"~     The purpose of this study is to characterize rosacea patients', being treated with Oracea,~     perception through visual analog scale reporting.~   "
129470|NCT01872702|"~     The overall aim of this study is two fold:~        1. to pilot targeted chemo-elimination of plasmodium falciparum malaria in known areas of~          artemisinin resistance in South East Asia.~        2. to understand the micro-epidemiology of malaria in these areas; chiefly, the prevalence~          and importance to on-going transmission of sub-clinical p.f malaria infections.~   "
129471|NCT01872689|"~     This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will~     evaluate the efficacy and safety of lebrikizumab as monotherapy in the absence of background~     IPF therapy or as combination therapy with pirfenidone background therapy in participants~     with IPF. Participants will be randomized to receive either lebrikizumab or placebo~     subcutaneously (SC) every 4 weeks.~   "
129514|NCT01872130|"~     The purpose of this study is to evaluate a new instrument that shines light and takes digital~     pictures of skin. The goal is to develop a technique that may enable fast and accurate~     assessment of surgical margins in the excision of basal cell carcinoma (BCC) or squamous cell~     carcinoma (SCC). The investigators will evaluate the pictures obtained by the confocal~     microscope to determine whether this technique may be useful in the future for helping Mohs~     surgeons remove cancers. In the future, patients may benefit with shorter surgery and~     improved care.~   "
129472|NCT01872676|"~     The aim of the present study was to assess the immediate effects of upper thoracic~     manipulation on skin surface temperature in the region of the T3 vertebra and biceps brachii~     muscle in healthy women. It is a randomized controlled blind study. Twenty-six healthy women~     of the university community were randomly allocated to an experimental group (n = 13) and a~     placebo group (n = 13). A single session of the upper thoracic spine manipulation (segment~     T3)was performed. Infrared thermography was used to determine changes in skin surface~     temperature in the region of T3 and the biceps brachii muscle, which would indirectly reflect~     sympathetic activity. Images were taken prior to manipulation, immediately after and both~     five and 10 minutes after manipulation. Repeated measures ANOVA with the post hoc Bonferroni~     test and the independent samples t-test were used for the intragroup and intergroup~     comparisons, respectively, with the level of significance set to 5%.~   "
129473|NCT01872663|"~     The aim of this study will be to investigate the effects of using physical therapy resources~     in the postoperative morbidly obese individuals undergoing gastroplasty.~      It is believed that the application of these various features of physiotherapy after~     abdominal surgery may contribute differently in restoring lung function and prevention of~     pulmonary complications and can thus identify the resources that can contribute more~     effectively in post-operative bariatric surgery.~   "
129474|NCT01872650|"~     Adhesions develop in more than 90% of patients undergoing an intra-abdominal surgical leading~     to serious consequences and complications at reoperation.~      The investigators initiate a prospective, randomized, controlled, multicenter trial to assess~     whether the use of C-Qur™ Film decreases the incidence of adhesion formation in subjects~     undergoing colorectal surgery. Treatment with the application of C-Qur™ Film as an adhesion~     prevention barrier for colorectal surgery will be compared with the control group at the~     second stage ostomy takedown procedure. The primary outcome evaluation will be assessment of~     adhesions to the incision site.~   "
129475|NCT01872637|"~     Hospitalization increases the risk for new disability in older adults. In the current health~     care system, home health physical therapy is understudied and often does not return older~     adults to prior levels of function. The proposed evidence-based multicomponent intervention~     that combines high intensity strength training and motor control based systems of gait and~     balance training will advance clinical practice by providing an intervention strategy for~     practitioners. If successful, improving patient function and decreasing re-hospitalization~     rates and falls will have large cost saving implications.~   "
129476|NCT01872624|"~     The combined use of one-way endobronchial valves and bone-marrow derived mesenchymal stromal~     cells in patients with severe pulmonary emphysema is safe and will contribute to increase~     quality of life.~   "
129477|NCT01872611|"~     The purpose of this study is to demonstrate superiority of Nepafenac Ophthalmic Suspension,~     0.3% dosed once daily relative to Nepafenac Vehicle based upon clinical outcomes among~     diabetic participants following cataract surgery.~   "
129478|NCT01872598|"~     The objective is to compare the efficacy and safety of oral masitinib 3 or 4.5 mg/kg/day in~     combination with cholinesterase inhibitors and/or memantine to placebo in combination with~     cholinesterase inhibitors and/or memantine in patients with mild-to-moderate Alzheimer's~     disease.~   "
129479|NCT01872585|"~     The purpose of this two-year pilot study is to adapt a 12-week attachment-based parenting~     intervention for implementation with female adult caregivers who have or are at risk for~     long-term interpersonal conflict with family members, children, or significant others and are~     caring for a child between the ages of birth and 7 years.~   "
129480|NCT01872572|"~     This was a Phase 1a, single-center, double-blind, randomized, placebo-controlled study of the~     safety, tolerability, PK, and PD of single ascending doses of RB006 administered as an SC~     injection, with and without IV RB007 (an active control agent for RB006), in healthy young~     volunteers. The study originally planned to enroll 4 cohorts of 8 subjects each (N=32);~     however, upon review cohort (Cohort 1-A) was necessary in order to fully define the PK~     profile of SC RB006. Therefore, 36 subjects were enrolled in this study.~      Each cohort was balanced by sex with no more than 2/3 of one sex enrolled in any particular~     cohort (i.e., 5 of 8 subjects in each cohort). No subject participated in >1 dose group, and~     progression to the next higher dose only occurred if the prior dose level was well tolerated,~     as assessed by a Safety Review Committee (SRC)~   "
129481|NCT01872559|"~     The study is designed to evaluate a new imaging modality, 3-dimmensional sonographic~     volumetric analysis, and compare it to the conventional 2-dimmensional analysis that is~     currently in place. Those patients who are scheduled to have an ultrasound as part of their~     infertility treatment will be offered the opportunity to have additional measurements done at~     the time of their ultrasound; these additional measurements will take less than 2 minutes and~     do no require any additional sonograms, tests, or interventions. All patients are eligible~     (oocyte donors and autologous oocyte patients) and only patients with a serum estradiol >~     2000pg/ML will be enrolled in the study. After the additional measurements are obtained, the~     results will be digitally stored. The results of the 3D sonographic volumetric analysis will~     then be correlated with the patients' IVF performance.~   "
129482|NCT01872546|"~     The expertise in the characterization of transcriptomics profile in lesional psoriatic skin~     and on the availability of innovative therapy for these patients.The investigators propose to~     follow the modification of the skin transcriptomics profile in psoriatic patients during~     successful Adalimumab biotherapy. Skin transcriptomics profiles of normal skin, psoriatic non~     lesional skin, and psoriatic lesional skin before and after biotherapy will be compared. The~     investigators will focus on the modification of the cytokine signature in these skin~     lesions and of some markers of keratinocyte inflammation. The modification of the~     transcriptomics profile induced by the biotherapy will be correlated to the clinical response~     Psoriasis Area and Severity Index.~   "
129483|NCT01872533|"~     The purpose of this study is to look at how a reduction in oxygen levels (hypoxia) influences~     insulin sensitivity and carbohydrate metabolism. It is expected that 10 nights of exposure to~     moderate hypoxia (~ 15% O2, similar to conditions at an altitude of ~7500 feet) will improve~     glucose metabolism.~   "
129484|NCT01872520|"~     Magnesium Lithospermate B, the main constituent of the Injection of DanShenDuoFenSuanYan (the~     Injection of Depsides Salts From Salvia Miltiorrhiza), is the active ingredient of Salvia~     Miltiorrhiza. This study record clinical use of The injection of DanShenDuoFenSuanYan in the~     real world, and observe the adverse drug reactions/ adverse drug events during treatment.~   "
129485|NCT01872507|"~     The effect of breathing biofeedback training to influence the function of the cardiac~     autonomic nervous system at rest and in activity in children with cerebral palsy.~      Cerebral palsy children suffer from a non-progressive damage of the brain. It is the most~     common injury that causes physical handicapped in childhood. There are a few researches that~     investigated the autonomic function in cerebral palsy children. Those researches found~     hyperactivity of the sympathetic autonomic system, including high resting heart rate compare~     to their typically developed pears. The recommended treatment for cerebral palsy is activity,~     muscle strengthening and mobility. The impairment in the autonomic system influences the~     everyday function and has correlation with secondary morbidity.~      As far as we know there are no researches who investigated the following issues.~      In this study we would like to:~        1. Describe the autonomic cardiac function, Breathing function, motor function and the~          correlation between them in children with cerebral palsy.~        2. Compare the autonomic cardiac function at rest in aerobic test and in diaphragmatic~          breathing.~        3. Test the influence of breathing training on Heart rate variability parameters at rest,~          in aerobic test right after the breathing training program and one month after, in~          children with cerebral palsy~   "
129486|NCT01872494|"~     Posterior thoracolumbar operation always chooses general anesthesia. Due to surgical trauma~     and rich periosteum and joint capsule innervation, patients after general anesthesia~     immediately feel acute pain.The use of appropriate postoperative analgesia in patients with~     thoracolumbar surgery is beneficial to postoperative recovery. Infusions of local anaesthetic~     via multilumen catheters that deliver directly to wound sites have been used for~     postoperative analgesia in procedures. Reducing the morbidity from both pain and nausea will~     make the mode of analgesia a better tolerated and more palatable option for patients. The aim~     of this study is to examine the effects of using local anaesthetic infusion catheters~     following posterior thoracolumbar surgery, and compares the outcomes of patients managed~     using intravenous analgesia pump infusion of systemic opioids.~   "
129487|NCT01872481|"~     Phantom Limb Pain (PLP) is a neuropathic chronic syndrome, characterized by a painful~     sensation in a body part that has been amputated. The incidence of phantom limb pain is~     between 50-80% of all amputees, however, additional risk factors as psychological trauma,~     blood loss, and infection increases its incidence after a traumatic amputation in landmine~     victims. Satisfactory management is often difficult to achieve and different clinical trials~     with medical and surgical measures have yielded unsatisfactory results. The response rate~     with pharmacologic treatment is around 30% using conventional medication as opiates and~     N-methyl-D-aspartate (NMDA) receptor antagonists, which is not significantly different from~     response rates with placebo.~      Recent case series have shown that repetitive Transcranial Magnetic Stimulation (rTMS) of the~     motor cortex can display an effectiveness that goes from 52% to 88% in the treatment of some~     refractory neurogenic pain cases which is quite superior to conventional management. However,~     the use of this type of treatment has not been studied in patients with phantom limb pain~     secondary to landmine injuries. The main objective of this trial is to evaluate the efficacy~     and safety of rTMS in the treatment of phantom limb pain in landmine victims.~      A double blind randomized placebo-controlled clinical trial, including 54 landmine victims~     with PLP will be performed. At the time of enrollment, a complete medical evaluation will be~     performed and those patients who meet the inclusion criteria will be randomly assigned to one~     of two groups, to receive rTMS in series of 20 trains of 6 s in duration (54-s intertrain~     interval) at a stimulation rate of 10 Hz (1200 pulses) and an intensity of 90% rest motor~     threshold using an active coil or a sham coil. Sessions will be administered 5 days a~     week (Monday to Friday) during two consecutive weeks. The stimulation will be directed to the~     primary motor cortex contralateral to the amputated limb. Response will be evaluated by~     measuring the pain intensity at baseline and after each session using a visual analog scale.~     These measurements will be repeated 2 weeks after the end of the treatment scheme, in order~     to determine the duration of the analgesic effect of rTMS~   "
129488|NCT01872468|"~     The propose of study is to study if an informative intervention and a structured follow-up~     carried out in health centres of primary care in patients with chronic kidney failure, stage~     3, is more effective than the current follow-up in slowing the disease progression measured~     by the glomerular filtration rate.~   "
129489|NCT01872455|"~     n-3 Polyunsaturated fatty acids (PUFAs) supplementation reduces systemic inflammation and~     improves renal and cardiovascular prognosis in kidney transplant recipients. A good patient~     compliance is often difficult to obtain because bad tasting fish oils are used as n-3 PUFA~     source. Therefore, we explored whether n-3 beneficial effects can be obtained by~     administering a diet based on n-3 rich foods.~   "
129490|NCT01872442|"~     Interferon alpha was a therapy used in Chronic Myeloid Leukemia in Chronic phase prior to the~     advent of tyrosine kinase inhibitors. Synergistic effect of the combination of Peg-IFNα2a~     with Imatinib was demonstrated in the clinical SPIRIT trial. In this study, the investigators~     address the question of the efficacy and safety of dasatinib in combination with low dose of~     Peg-IFNα-2b as frontline therapy for patients with newly diagnosed Chronic Myeloid Leukemia~     in Chronic phase.~   "
129491|NCT01872429|"~     The impact of parathyroidectomy (PTX) on the bone mineral parameters in dialysis patients~     with secondary hyperparathyroidism (SHPT) remains unclear. The investigators performed this~     study to present the short- and long-term impact of PTX on calcium, phosphorus and intact~     parathyroid hormone control in dialysis patients with severe SHPT after operation. In~     particular, the investigators evaluate the impact based on the achievement of recommendations~     of the current clinical practice guidelines for bone and mineral parameters in dialysis~     patients after PTX.~   "
129492|NCT01872416|"~     At present, there is no standard second-line treatment of refractory and relapsed SCLC,~     topotecan, gemcitabine, paclitaxel, irinotecan and drugs such as cyclophosphamide second-line~     treatment of small cell lung cancer currently being explored, Anthracycline antibiotics is a~     cell cycle non-specific anticancer drugs could inhibit the synthesis of DNA, DNA and~     dependent RNA, its wide antitumor spectrum, widely used in malignant hematologic diseases and~     lung cancer and other solid tumors. Jacot W, et al evaluated epirubicin combined with~     ifosfamide (EI) for treatment of refractory and recurrent SCLC in 70 cases, the objective~     response rate (ORR) reached 21.4%, including 1 cases of complete remission, 10% other~     patients obtained stable disease (SD), all the patients had a median survival of 3.9 months,~     most (71%) patients with neutropenia, platelet count and anemia are also common, showed that~     EI treatment of refractory and relapsed SCLC is effectively controlled, toxicity.~      In view of epirubicin combined with ifosfamide (EI) scheme is effective and safety in the~     treatment of refractory and relapsed SCLC, the investigators will use liposomal doxorubicin~     plus ifosfamide second-line treatment of refractory and relapsed small cell lung cancer, may~     obtain better tumor remission rate, improve the prognosis of the patients.~   "
130668|NCT01856998|"~     The purpose of this study is to evaluate the therapeutic equivalence, based on~     pharmacodynamic parameters of Propofol 2% (20 mg/mL) MCT Fresenius and Diprivan® 20 mg/mL~     (AstraZeneca), administered by target controlled infusion (TCI).~   "
129494|NCT01872390|"~     The purpose of the START Study is to identify an effective, cost-effective, acceptable~     intervention that addresses programmatic, structural and psychosocial barriers to ART~     initiation and retention during TB treatment, with the ultimate goal of improving health~     outcomes among HIV-infected TB patients in Lesotho. The study is a two-arm cluster randomized~     trial, randomized at the TB/HIV clinic level, which includes twelve TB/HIV clinics in Berea~     district. Clinics are randomized to deliver the combination intervention package (CIP) or~     standard of care (SOC), with stratification by facility type. The experimental intervention~     will be delivered to all HIV-infected TB patients in TB/HIV clinics randomly assigned to CIP.~     In TB/HIV clinics assigned to SOC, usual care procedures for ART initiation and retention~     will be delivered.~      Study hypotheses focus on the effectiveness of the CIP on HIV- and TB-related outcomes.~      Compared to HIV-infected TB patients attending SOC clinics, HIV-infected TB patients at CIP~     clinics will have superior HIV- and TB-related outcomes, including:~        -  Greater ART initiation during TB treatment~        -  Shorter time to ART initiation~        -  Greater retention in ART care~        -  Higher adherence to ART~        -  Greater change in CD4+ count~        -  Greater TB treatment success (completion and cure)~        -  Greater sputum smear conversion~        -  Higher adherence to TB treatment~      Additionally, CIP delivery will have an incremental cost-effectiveness ratio more favorable~     than alternative resource uses.~   "
129495|NCT01872377|"~     Currently the standard treatment for locally advanced, unresectable pancreatic cancer~     consists either of chemotherapy by itself or a combination of chemotherapy plus radiation~     therapy or no treatment at all. Unfortunately, no treatment thus far has been able to provide~     patients with a consistent chance for a cure although there are rare patients who will live~     for many years after treatment. For most patients the chemotherapy or chemotherapy plus~     radiation will maintain or improve quality of life by keeping the cancer under control for a~     period of time.~      Approximately 25-30% of patients with early pancreatic cancer who are able to have the cancer~     completely removed surgically will live beyond 5 years and will be considered cured. This~     tells us that aggressive treatment directed at the tumour in the pancreas can lead to cure.~     For the majority of patients who can not have an operation, giving more radiation as part of~     the treatment may be a strategy that results in better control of the tumour in the pancreas~     which may or may not result in patients living longer.~      The purpose of this study is to test the safety of adding a higher dose (a boost dose) of~     radiation using a radiation unit called CyberKnife when combined with standard chemotherapy~     and radiation for patients with locally advanced, unresectable pancreatic cancer.~      Participants on this study will receive a 'boost' dose of radiation which consists of 3~     treatments over 1 week. The participants will then receive the standard of care treatment of~     chemotherapy and standard radiation therapy over a 5 week period, which will be followed by~     the conventional 20 weeks of chemotherapy alone. The participants will then be followed for~     progression of disease and toxicity related to the boost treatment for up to 5 years.~   "
129496|NCT01872364|"~     Expenditures on material supplies and medications constitute the greatest per capita costs~     for surgical missions. We hypothesized that supply acquisition at nonprofit organization cost~     would lead to significant cost-savings compared to supply acquisition at US academic~     institution costs from the provider perspective for hernia repairs and minor procedures~     during a surgical mission in the Dominican Republic.~   "
129497|NCT01872351|"~     The purpose of this study is to determine whether therapy that has been shown to be~     beneficial for mitochondrial diseases is also beneficial for Chronic Fatigue Syndrome (CFS)~     patients. This study is a chart review of previous CFS patients who received daily~     conditioning exercise, a high protein diet and nutraceutical therapy (ENT). Prescribed~     nutraceutical supplements included alpha-lipoic acid, acetyl-L-carnitine, omega-3fatty acids~     (maxDHA), coenzyme Q10 (CoQ10), plus a multivitamin.~      Twelve CFS male and female patients between the ages of 20-70 years will be recruited to~     participate in this pilot study. Subjects will be eligible to participate if they meet the~     criteria for CFS of the Centers for Disease Control and Prevention (CDC). These include~     persistent, unexplained fatigue for at least 6 months, concurrent with four of the following:~     impaired memory/concentration, sore throat, new headaches, unrefreshing sleep, muscle pain,~     multi-joint pain, tender lymph nodes, and post-exertional malaise.~   "
129498|NCT01872338|"~     The purpose of this study is to test a psychotherapeutic intervention that integrates~     cognitive therapy and mindfulness meditation techniques to prevent suicide in military~     Veterans.~   "
129499|NCT01872325|"~     The main goal of this project is to help 9-1-1 emergency medical dispatchers save the lives~     of more cardiac arrest victims. The investigators will develop teaching tools to help the~     dispatchers recognize abnormal breathing that may indicate a victim as having a cardiac~     arrest. After training sessions, the investigators will see if dispatchers can get better at~     recognizing abnormal breathing, how often they give CPR instructions, and if use of the~     teaching tool will increase bystander CPR and the number of victims leaving the hospital~     alive.~   "
129500|NCT01872312|"~     This procedure allows patients to use the Humanitarian Use Device, IBV® Valve System.~   "
129501|NCT01872299|"~     SICA-HF is a prospective, multicentre, multinational, longitudinal, pathophysiological~     evaluation study, which is being conducted in 11 centres across six countries. SICA-HF~     receives funding from the European commission's Seventh Framework Programme (FP7/2007-2013)~     under grant agreement no. 241558 (SICA-HF) and from the Russian Ministry of Science and~     Education within the file transfer protocol R&D in priority fields of the S&T complex of~     Russia 2007-2012 under state contract number 02.527.11.0007. The aim of SICA-HF is to~     provide detailed characteristics of co-morbidities of heart failure at baseline and over~     time, particularly with regards to obesity, cachexia, and type 2 diabetes.~   "
129502|NCT01872286|"~     Capsule endoscopy has been shown to be the first-line endoscopic procedure for small bowel~     disease. This study was aimed to compare the performance between the frequency-altering AKE-1~     capsule and the Pillcam SB2 in patients with suspected small bowel disease.~   "
129503|NCT01872273|"~     Moderate exercise is recommended to improve cardiovascular health in obese and overweight~     people particularly with metabolic syndrome (MetS) that have hypertension, elevated fasting~     blood sugar, and elevated blood lipids. This study is being done to determine how platelets~     respond when a person performs an initial period of moderate exercise.~   "
129504|NCT01872260|"~     The purpose of this trial is to inform the future clinical development of the two~     investigational agents in ER+ breast cancer, LEE011 (CDK4/6 inhibitor) and BYL719 (PI3K-alpha~     inhibitor).~      This is a multi-center, open-label Phase Ib study. The Phase Ib dose escalation will estimate~     the MTD and/or RP2D for three regimens: two double combinations, LEE011 with letrozole and~     BYL719 with letrozole, followed by triple combinations of LEE011 + BYL719 with letrozole~     (Arms 3 and 4).~      The Phase Ib dose escalation part will be followed by Phase Ib dose expansions to further~     characterize the safety, tolerability, PK and preliminary clinical anti-tumor activity of the~     combinations. Optional crossover for patients who have progressed while on dose escalation or~     dose expansion with doublet treatment on Arms 1 or 2 to be treated with the triplet~     combination (Arm 3) after the determination of the RP2D for Arm 3; is no longer permitted~     after protocol amendment 6.~      Approximately 250 adult women with ER+/HER2- locally advanced or metastatic breast cancer~     will be enrolled.~   "
129505|NCT01872247|"~     HP-hMG, recombinant FSH (r-hFSH) and a combination of r-hFSH/r-hLH, are commonly used for~     ovarian stimulation in infertile women undergoing IVF/ICSI treatments. Several publications~     have compared the effectiveness of these compounds, in terms of clinical outcomes.~      The aim of our study is to investigate the effects of three different ovarian stimulation~     protocols (HP-hMG, r-hFSH and r-hFSH/r-hLH), in a pilot prospective observational study,~     evaluating the effects of recombinant LH and extractive hCG (with LH like activity) on the~     biological outcome as well as on the clinical outcome. We will use the apoptosis rate of the~     cumulus cell, usually discarded after oocyte collection, as molecular biomarker to assess the~     oocyte quality, as biological outcome. The clinical outcome was estimated measuring~     implantation and ongoing pregnancy rates within and between the three different ovarian~     stimulation protocols~   "
129506|NCT01872234|"~     The purpose of this trial or study is to determine if pacemaker therapy can be a beneficial~     alternative to conventional medical therapy in patients with a history of moderate heart~     failure. The investigators are looking to enroll approximately 180 people in this trial.~     Patients will be randomized in two groups. One group will be implanted with a pacemaker and~     will continue to receive conventional medical therapy as prescribed by their doctor. The~     second group will continue to receive conventional medical therapy as prescribed by their~     doctor and will not be implanted with a pacemaker. Clinical histories, physical exams, and~     external device testing will be collected both at the time of enrollment in the trial and~     during follow-up study visits. Patients who enter the study will be seen for study visits at~     1 month, 3 and 6 months.~   "
129507|NCT01872221|"~     This is a prospective biomedical study of interventional type which includes 16 patients on~     52 months (24 months of inclusion and 28 months of follow up).~      This pilot study, combining a metabolic imaging approach (Proton Magnetic Resonance~     Spectroscopy = 1HMRSI) and a biological one, will be performed in patients harbouring a~     Glioblastoma (GBM)to determine whether MRI markers of aggressiveness (CNI2) are associated~     with specific biological patterns as regards to GBMSC (GBM contains tumor stem cell).~      In the first part of the study, patients with radiological criteria of GBM amenable to~     surgical resection will be included ; pre-operative multimodal MRI scans will be done and all~     data acquired (including H1MRS and DTI data) will be integrated in the image-guided surgical~     device (ie neuronavigation system) to be used intraoperatively. During tumor resection,~     tissue samples will be individualized, based on their multimodal imaging characteristics and~     sent to the radiobiology laboratory INSERM for biological analysis.~      After surgery, patient will be treated by the standard radio-chemotherapy stupp protocol and~     will be followed according to standard practices; multimodal MRI will be performed every 2~     months during the first year and then every 3 months until progression.~   "
129508|NCT01872208|"~     The purpose of this study is to assess the safety and efficacy of a novel, tissue-engineered~     vascular prosthesis, the Human Acellular Vascular Graft, HAVG.~      The HAVG is intended as an alternative to synthetic materials and to autologous grafts in the~     creation of an above-knee femoro-popliteal bypass graft in patients with peripheral arterial~     disease.~   "
129509|NCT01872195|"~     This project aims to produce a systematic review on present knowledge on effects of using~     safety checklists in medicine. Implementation of a checklist system throughout surgical care~     may reduce patient morbidity and mortality. The reliability of patient data is crucial to~     make firm conclusions as to such effects. This project aims to investigate if such morbidity~     and mortality effects are obtainable in two Norwegian hospitals while at the same time making~     a crucial evaluation of the patient data used in this study itself.~      We hypothesise~        1. An updated systematic review of the research literature provide evidence that safety~          checklists use does enhance safety and reduces patient mortality and morbidity~        2. Implementation of the patient safety checklist system will reduce patient mortality and~          morbidity in the checklist cohort, and subsequent effects on length of stay~        3. The sensitivity and specificity of ICD-10 coding vs. medical journal information is~          poor, with study results to be adjusted accordingly.~   "
129510|NCT01872182|"~     The main objective of this study is to evaluate efficacy and safety of ALS-L1023 tablet in~     patients with abdominal obesity of metabolic syndrome.~   "
129511|NCT01872169|"~     Gastroenterological disorders are disorders affecting the stomach, intestines and associated~     organs. Symptoms of these types of disorders vary but often include vomiting, diarrhoea,~     weight loss and loss of appetite. Due to the nature and symptomatology of these disorders~     research has suggested that sufferers may be vulnerable to developing disordered eating~     behaviours. Treatment of such disorders often requires dietary restriction which has been~     found to lead to an obsessive preoccupation with food and in some cases to an increase in~     binge eating. Further to this, symptoms of Gastroenterological disorders such as vomiting~     have also been suggested to be linked with disordered eating. At the present there is limited~     research in this area and as such evidence is inconclusive. Particularly little research has~     looked at this area in relation to adolescents, who have been recognised as being at~     increased risk for the development of disordered eating . Gastroenterological disorders are~     likely to affect the typical development of eating habits and therefore it seems plausible~     they may also predispose adolescents to developing abnormal eating behaviours /weight~     concerns.~      The aim of this study is to further investigate the possibility that Gastroenterological~     disorders may be a risk factor for disordered eating in children and adolescents. This study~     will recruit children/ adolescents aged 5-17 and their parents, who are attending Great~     Ormond Street Gastroenterology Clinic and ask them to complete a screening questionnaire. The~     recruitment process will be on going for around 5 months until the study has around 300~     participants. Following this initial questionnaire, participants who are categorised as~     screening positively for disordered eating and a 10% sample of participants that screen~     negatively, will be contacted to complete a further questionnaire interview that will look~     more specifically into this area.~   "
129512|NCT01872156|"~     The purpose of this study is to evaluate the effectiveness of the behavior treatment~     accompanied by self-help materials in Primary health care, across the intervention of the~     midwifes in the pregnancy follow-up visits.~   "
129515|NCT01872117|"~     The deep heat therapies are increasingly frequent in daily physical therapist for the~     treatment of musculoskeletal diseases. The use of such procedures is justified by their~     analgesic, anti-inflammatory, antiespasmolíticos and hiperemiantes. However, studies on the~     cardiovascular effects of these therapies are still incipient. Therefore, this study has as~     objectives: map the skin temperature changes in the lower limbs in different areas and~     positions after applying shortwave diathermy and microwave; assess hemodynamic and autonomic~     cardiovascular parameters, and investigate the occurrence of changes in conduction velocity~     superficial blood resulting from the application of these thermal features. The study will be~     conducted on 40 female volunteers between 18 and 30 years, university, healthy, that fit the~     inclusion and exclusion criteria of the study. The analysis by infrared thermography will be~     held in a room with temperature maintained at 23 ± 1°C and humidity average 50%. The~     volunteers will stay in prone position, with the legs bare, resting for 20 min to stabilize~     skin temperature with temperature of the room. After this period will be held applying~     diathermy of shortwave or microwave for 20 minutes at moderate heat on the lower limb regions~     of the hamstrings and triceps surae in extension and flexion to 180° to 90°. The records beat~     to beat blood pressure and heart rate to autonomic and cardiovascular hemodynamic evaluation~     will be performed by means of equipment Finometer (Finapress Medical Systems, Inc.) and~     electrocardiogram (ADInstruments, Inc.), respectively, before and after application of~     diathermy. On the other hand, the images will be processed using FLIR ThermoScan and blood~     flow data will be collected through the Doppler ultrasound. The results will be processed and~     analyzed using descriptive statistics, submitted to a linear regression model with mixed~     effects (random effects and fixed), with p≤0.05.~   "
129516|NCT01872104|"~     This research is a prospective randomized controlled trial.It aimed to determine longterm~     outcomes and factors associated with increased survival after photodynamic therapy (PDT)~     through colonscopy compared with chemotherapy alone in patients presenting with advanced~     rectal cancer.~   "
129517|NCT01872091|"~     Cryotherapy is a resource applied thermal rehabilitation in order to reduce skin temperature~     and muscle as well as nerve conduction velocity, and promotes vasoconstriction of arteries~     and veins resulting in decreased blood flow.~   "
129518|NCT01872078|"~     To assess the effects of AZD4901 when given in multiple doses to females with Polycystic~     Ovary Syndrome~   "
129519|NCT01872065|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of~     ARC-520 in normal, adult volunteers.~   "
129520|NCT01872052|"~     Study to determine the feasibility of the Acutus Medical System in obtaining data to create~     Dipole Density Maps of electrical activation in the right atrium in patients with typical~     atrial flutter.~   "
129521|NCT01872039|"~     To compare the efficacy and safety of two dose adjustment regimens (i.e. weight-based and~     non-weight-based) for the treatment of Chinese hypertensive emergency patients.~   "
129522|NCT01872026|"~     This study is to assess the safety, tolerability, plasma concentration and pharmacodynamics~     of ASP7991 after oral administration to patients with chronic kidney disease undergoing~     hemodialysis.~   "
129523|NCT01872013|"~     This study is to assess the safety, tolerability, plasma concentration and pharmacodynamics~     of ASP7991 after multiple oral administrations to non-elderly subjects.~   "
129524|NCT01872000|"~     Following cataract surgery, an intraocular lens (IOL) is implanted in the eye. The majority~     of people develop an operable cataract when they are over the age of 50. Occasionally people~     under 50 years develop a cataract requiring an operation. The visual demands in this age~     group are very different due to both physiological and lifestyle factors. Traditionally IOLs~     are focussed for distance vision and additional spectacles are worn for near vision. Under~     the age of 45 years we have the ability to naturally change the focus of our eyes and do not~     require additional reading glasses. This is known as accommodation. By removing the~     cataractous lens and replacing it with an IOL with a fixed single focus, both eyes work~     together for distance vision but only the unoperated eye is able to change focus for~     different working distances. This study aims to establish whether a multifocal IOL implanted~     in one eye is able to complement the accommodation in the other eye so the 2 eyes work more~     effectively together. This may enhance depth perception and improve the quality of vision.~     Depth perception is important for more comfortable vision on the computer screen, when~     reading and for jobs that require good depth perception.~   "
129525|NCT01871987|"~     A study to evaluate the effect of food on the plasma concentration changes of quetiapine~     after oral administration of FK949E (extended release formulation of quetiapine) in healthy~     male subjects.~   "
129526|NCT01871974|"~     The objective of the study was to evaluate the safety and plasma concentration changes of~     quetiapine after multiple oral administration of FK949E (extended-release formulation of~     quetiapine) in patients with major depressive disorder (MDD).~   "
129527|NCT01871961|"~     To evaluate the human factors/usability of Rheumatoid Arthritis (RA) patients with the~     Metoject® prefilled pen (including a label comprehension assessment and a device robustness~     evaluation).~   "
129528|NCT01871948|"~     Cancer patients often experience problems in their care, many of which are caused by~     communication breakdowns. Some communication breakdowns lead to adverse events and even~     harmful errors. Deficiencies in provider-patient communication can compound patients'~     distress, lower the quality of care, and disrupt patient-provider relationships. There is~     little research on patients' and providers' experiences of the communication breakdowns that~     precipitate adverse events and errors, or on effective responses to these events. Because of~     this, cancer providers are unsure how to communicate with patients in these difficult~     situations. The goal of the proposed study is to improve patient-centered communication~     around adverse events and errors in cancer care. Our specific aims are: 1) To describe~     patients' experiences with communication around adverse events and errors in cancer care, 2)~     To describe providers' experiences and practices with communication around adverse events and~     errors in cancer care, 3) To develop practical recommendations, provider training materials~     and patient educational materials for improving communication around adverse events and~     errors in cancer care, 4) To disseminate the recommendations and materials through three~     health plans, and 5) To conduct a preliminary evaluation of the perceived usefulness and~     impact of the materials. The investigators will first conduct interviews with breast and~     colorectal cancer patients who have experienced adverse events or errors at 3 Cancer Research~     Network (CRN) health plans (Atlanta, Georgia; Seattle, Washington and Worcester,~     Massachusetts). The interviews will focus on instances where patients believe that better~     communication might have prevented an adverse event or error, or mitigated the event's~     impact. Next the investigators will conduct focus groups to understand providers' attitudes~     and experiences with these communication dilemmas, and use simulations to describe providers'~     communication practices. Finally, the investigators will interview health plan leaders to~     identify the systems factors that influence communication with patients around adverse events~     and errors. These perspectives will be synthesized to create patient and provider educational~     material for improving communication. Three advisory panels: a Patient Advisory Panel, a~     Health Plan Advisory Panel and a Dissemination Advisory Panel (including all 14 CRN health~     plans) will help create and disseminate these educational interventions. Dissemination will~     occur at the three core clinical sites. The investigators use patient and provider surveys to~     evaluate the educational materials' impact. This evaluation will provide the evidence-base to~     refine the study products before widespread dissemination throughout the CRN and beyond. The~     project will have the advantage of the CRN infrastructure, the CRN Clinical Communication~     Research Center, and is led by nationally recognized communication researchers.~   "
129535|NCT01871857|"~     Research suggests that hypertonic saline may improve mucous flow in infants with acute~     bronchiolitis. Data suggest a trend favoring reduced length of hospital stay and improved~     pulmonary scores with increasing concentration of nebulized solution to 3% and 5% saline as~     compared to 0.9% saline mixed with epinephrine. To our knowledge, 7% hypertonic saline has~     not been previously investigated. OUr hypothesis was that 7% hypertonic saline would improve~     bronchiolitis severity scores and admission rate.~   "
129529|NCT01871935|"~     Induction of general anaesthesia with a combination of opiates and hypnotics often induces~     vasodilation resulting in several haemodynamic effects such as a decrease in blood pressure~     (MAP), heart rate (HR) and cardiac output (CO). This haemodynamic suppression may jeopardize~     tissue oxygenation, particularly cerebral oxygenation. Previous research of the investigators~     group has revealed that atropine has an exceptionally beneficial effect on the determinants~     of tissue oxygen delivery as well as on tissue oxygenation. The investigators have~     demonstrated a significant and clinically relevant increase in CO and cerebral tissue~     oxygenation (SctO2) for a desired increase in MAP. This is in steep contrast with the more~     usual clinical practice of administrating classical vasoactive medication such as~     phenylephrine or norepinephrine, since the two latter have an even negative effect on CO and~     SctO2. In previous research the investigators used standardized target controlled~     propofol/remifentanil infusions for induction and maintenance of anaesthesia. It is known~     that remifentanil has more intense haemodynamic side-effects compared to other opiates such~     as fentanyl, sufentanil or alfentanil. This raises the question whether the beneficial effect~     of atropine is restricted to propofol/remifentanil anaesthesia, or if this is equally valid~     during anaesthesia of propofol combined with other opiates such as sufentanil.~      Patients undergoing off-pump coronary artery bypass grafting (CABG) require a long and deep~     general anaesthesia, which is usually performed with the combination of drugs as mentioned~     above. Because these patients often experience severe haemodynamic fluctuations they need to~     be closely monitored.~   "
129530|NCT01871922|"~     Remifentanil is a widely used potent intravenous opioid with the advantage of having a short~     time of action. Compared to other opiates however remifentanil generates more intense~     hemodynamic side-effects. In ophthalmic surgery the specific anesthesiological challenges~     necessitate the administration of a combination of relatively high doses of analgesics on the~     one hand and a short time for postoperative recovery from anesthesia on the other. For these~     reasons, anesthetic management often consists of a combination of relatively high doses of~     propofol and remifentanil. A primary concern during this deep propofol/remifentanil~     anesthesia is preserving hemodynamic stability and adequate tissue oxygenation. Previous~     research of the investigators group has revealed that atropine has an exceptionally~     beneficial effect on hemodynamics as well as on tissue oxygenation. Therefore, the~     investigators hypothesize that administration of intravenous atropine during induction of~     propofol/remifentanil may have a positive effect on the hemodynamic profile and peripheral~     and cerebral tissue oxygenation during and after induction of anesthesia.~   "
129531|NCT01871909|"~     Lower body negative pressure (LBNP) is a laboratory model used to study hemorrhage in humans.~     The investigators hypothesize that the physiologic changes that occur with application of~     LBNP mimic those observed in bleeding and hemodynamically unstable trauma patients, and that~     LBNP is a truly valid model of human hemorrhage.~   "
129532|NCT01871896|"~     Morbid obesity and its associated metabolic diseases are on the rise in the United States.~     Currently, the best treatment for obesity is bariatric surgery where both roux-en-Y gastric~     bypass and sleeve gastrectomy offer substantial weight loss. Unfortunately, 20% of patients~     who undergo bariatric surgery fail to lose enough weight defined as less than 50% of excess~     body weight loss or regain of weight. For those patients who fail to lose weight after~     bariatric surgery and have failed maximal medical therapy and diet supervision, the treatment~     is re-operation and revision. Re-operation of the abdomen carries significant postoperative~     morbidity and mortality. The investigators propose to use the Apollo OverStitch endoscopic~     suturing device that has already been approved by the FDA as an option for bariatric surgery~     revision without having to re-operate on the patient. The investigators believe that the~     endoscopic technique may be able to provide weight loss without having to re-operate on the~     patient.~   "
129533|NCT01871883|"~     Sensitive skin syndrome is defined as the presence of burning, itching or any other~     unpleasant sensation on the skin, due to physical, chemical or psychological factors. It is~     frequently a self-diagnosed condition, and there are no accurate tests to recognize or~     quantify it because of the individual variations in perception and intensity of the related~     symptoms. The most accepted physiopathogenic theory is the presence of an altered barrier~     function of epidermis. Also, changes in the pH of the stratum corneum have been found to~     induce skin sensitivity through the activation of the transient potential receptor vanilloid~     (TRPV) neuronal receptors.~      TRPV1 has been found in human keratinocytes, although its physiologic role in the skin is not~     yet established. Their presence in keratinocytes and cutaneous nervous fibers suggests a role~     in the sensitive function of the epidermis. Since this receptors can be activated by low pH~     (< 5.9), which is also important for the development of sensitive skin, we hypothesized that~     an increase in the expression of these receptors can be the responsible for the syndrome.~   "
129534|NCT01871870|"~     The objectives of this outpatient research study are (1) to assess the ability of this~     automated system to be operated by a subject with limited professional oversight; (2) to~     assess whether the new devices (Dexcom Gen 4 sensors, Motorola ES400 smart phone, iDex pump~     controller) will reduce the frequency of hardware and data communication lapses seen in the~     previous system; and (3) to measure the degree of glucose control achievable with this~     automated system. The system will adjust blood glucose by administering insulin and glucagon.~     Insulin is a hormone that lowers blood glucose and will be given nearly continuously during~     this study. Glucagon raises blood glucose and will be automatically administered during~     hypoglycemia. Both are natural hormones made by people without diabetes. Each subject will~     have four devices placed on his abdomen: two Omnipod insulin pumps, one for delivering~     insulin and one for delivering glucagon, and two Dexcom G4 glucose sensors for measuring~     glucose. The two sensors will feed glucose data into Motorola smart phone master controller,~     which will calculate the correct amount of insulin or glucagon to deliver. The system will~     then send the command to the correct Omnipod through the iDex pod controller.~      In this new system, the research subject will be able to monitor the progress of the study by~     use of the smart phone graphical user interface. The subject will have a companion with~     him/her during the entire study for safety purposes. Both the subject and companion will~     complete a training course on how to treat diabetic emergencies and how to operate the~     system. A study physician and technician will be in the hotel during each study and will be~     monitoring the study via a cloud-based data communication system. These studies will be~     carried out in a hotel setting.~   "
129536|NCT01871844|"~     This was a within group, randomised, repeated dose, placebo- and octreotide controlled study~     in a target population of 45 healthy male subjects. Subjects were required to attend the~     clinical for screening procedures between 3 and 28 days before dosing commenced. The study~     was conducted in 4 groups of subjects; Groups 1 to 3 were a double-blinded, randomised~     design, each consisting of 12 subjects. Group 4 was an open-label design and consisted of 9~     subjects. There was a minimum interval of 96 h between dosing of Groups 1, 2 and 3 to allow~     for interim analyses of PK and safety/tolerability data for dose escalation purposes. Group 4~     (the active control group) was still to proceed if the decision was taken to prematurely stop~     dosing with ITF2984 (somatostatin analogue) following review of the PK and safety data~     presented at the interim decision meeting; dosing of this group was conducted independently~     from Groups 1 to 3. On Days 1 to 6, subjects in Groups 1 to 3 were to receive 2 doses of~     investigational medicinal product (IMP) approximately 12 h apart; subjects in Group 4 were to~     receive 3 doses of IMP approximately 8 h apart. For all groups, subjects were scheduled to~     receive their final dose of IMP on the morning of Day 7.~      In addition, subjects were to receive exogenous test administrations(stimulation test) on Day~     -1, Day 1 and Day 7 at the same time on each day (ie for Day -1, 23.5 h before the first dose~     of IMP, and for Days 1 and 7, 0.5 h after the first dose of IMP on the respective day). Blood~     samples for PD and PK analyses were taken at specified time points after each dosing.~      Subjects remained on site for 10 days (ie 36 h after the final dose of IMP on Day 7)~     providing that discharge conditions had been met, and returned to the clinic between 5 and 10~     days after the last IMP administration for a follow-up visit.~   "
129537|NCT01871831|"~     Systems for blood glucose monitoring with glucose oxidase enzyme reaction on test strips can~     be affected by the partial pressure of oxygen of the blood sample. In this study, we~     investigate the influence of different partial pressure of oxygen in blood samples on~     measurement results. Systems with labelled oxygen-dependency as well as systems without~     labelled oxygen-dependency are evaluated.~   "
129538|NCT01871818|"~     The purpose of this study was to compare the effectiveness of two rehabilitation programs~     (one month) in patients with multiple sclerosis. The first program is combined with~     physiotherapy, endurance training and resistance training. The second one is physiotherapy in~     private practice. Another purpose is to assess the length of the benefits of the combined~     program.~   "
129539|NCT01871805|"~     This non-randomized, open-label, multicenter study will evaluate the safety and efficacy of~     CH5424802/RO5424802 in patients with ALK-rearranged non-small cell lung cancer who failed~     crizotinib treatment. In Phase I, cohorts of patients will receive escalating doses of~     CH5424802/RO5424802 orally twice daily. In Phase II, patients who failed crizotinib treatment~     will receive the recommended phase II dose (600 mg) daily in two oral doses.~   "
129540|NCT01871792|"~     Contrast-induced nephropathy (CIN) is a well-recognized complication of radiographic contrast~     administration and is associated with increased short- and long-term mortality. Previous~     strategies including forced diuresis with diuretics or mannitol, intravenous administration~     of fenoldopam or dobutamine, and postprocedure hemodialysis to prevent CIN have been largely~     unsuccessful. In addition, the use of N-acetylcysteine to prevent CIN has yielded conflicting~     outcomes.~      A review of a large insurance database and retrospective study have shown that statins~     therapy is associated with a lower incidence of CIN after percutaneous coronary intervention.~     The preventive effect of statins on CIN may be attributed to direct pleiotropic effects on~     the vascular wall such as improvement of endothelial dysfunction, anti-inflammatory or~     anti-oxidative effect. However, recent randomized trial could not demonstrate the preventive~     effect of statin on CIN in patients with chronic kidney disease.~      Thus, we will investigate the preventive effect of pitavastatin on CIN in patient with renal~     dysfunction undergoing coronary angiography or intervention.~   "
129541|NCT01871779|"~     Cardiovascular disease remain one of the leading causes of death in Australia, accounting for~     47637 (36%) of deaths in 2004.~      Peripheral arterial disease (PAD) is a category of cardiovascular disease, characterised by~     intermittent claudication. This is defined as walking induced pain, cramping, aching,~     tiredness or heaviness in one or both legs that does not go away with continued walking and~     is relieved with rest. It is estimated that between 5-10% of individuals aged over 50 years~     suffer from claudication. The primary and most effective treatment for these patients is~     focused on improving walking ability and functional status.~      Current research has shown that approximately 30% of patients improve with exercise, while~     30% continue to deteriorate and the rest show no change. The changes produced at a~     biochemical and cellular level due to exercise are unknown. To help better understand this,~     our study will assess the entire range of proteins expressed before and after exercise in the~     skeletal muscle tissue of patients with intermittent claudication. This will help to~     identifying key proteins that have a role in improving patient symptoms and outcome.~   "
129542|NCT01871766|"~     This study will treat participants with newly diagnosed, low, intermediate and high risk~     rhabdomyosarcoma (RMS) using multi-modality risk-adapted therapy with standard or intensified~     dose chemotherapy, radiation and surgical resection. Intermediate and high risk participants~     will receive an additional 12 weeks (4 cycles) of maintenance therapy with anti-angiogenic~     chemotherapy.~      PRIMARY OBJECTIVE:~        -  Estimate event-free survival for intermediate risk participants treated with~          vincristine, dactinomycin and cyclophosphamide with the addition of maintenance~          anti-angiogenic therapy.~      SECONDARY OBJECTIVES:~        -  Estimate the false negative rate and incidence of additional positive lymph nodes in~          participants undergoing sentinel lymph node biopsy followed by limited nodal dissection.~        -  Maintain a high local control rate in participants treated with surgery and/or limited~          volume proton and photon radiation without dose escalation.~        -  Define the incidence and type of failure in participants who receive risk-adapted local~          therapy relative to the primary tumor volume.~        -  Establish the feasibility of delivering 4 cycles of maintenance anti-angiogenic~          chemotherapy in intermediate and high risk patients following standard chemotherapy.~        -  Estimate the event free survival for high risk patients receiving interval dose~          compressed therapy and maintenance anti-angiogenic therapy.~        -  Define the incidence of CTC grade 3 and higher toxicities (and specific grade 1-2~          toxicities) related to proton beam therapy.~   "
129543|NCT01871753|"~     The purpose of this study is to compare antibiotics versus no-treatment in kidney transplant~     recipients with asymptomatic bacteriuria.~   "
129548|NCT01871688|"~     As cancer treatment improves, the cancer survivor's quality of life and level of function~     have gained increasing importance. Pelvic floor function is directly affected by~     gynecological cancer and treatment, and pelvic floor dysfunction (PFD) can severely affect a~     patient's life. PFD negatively affects health-related quality of life (HRQOL). Evaluation of~     PFD provides information about the disease burden and treatment-related effects directly from~     the patient's perspective and informs clinical decision-making. The pelvic floor musculature~     and sacral nerves are not easily accessible, and it is difficult to test them. Several~     functional assessments have been used to evaluate pelvic floor dysfunction; however, reports~     on methodology are sparse, and consensus on their use is lacking. Research on functional~     outcomes is highly complex and, consequently, must be addressed in a comprehensive framework.~   "
129549|NCT01871675|"~     The goal of this study is to characterize the safety, maximum tolerated dose (MTD) and~     preliminary efficacy profile of IPI-145 given in combination with rituximab, or bendamustine~     plus rituximab, to subjects with select relapsed/refractory hematologic malignancies.~   "
129550|NCT01871662|"~     The purpose of this study is to explore whether silibinin plus ribavirin with/without~     peg-interferon can be more effective than the peg-interferon plus ribavirin based standard of~     care (SoC) in the treatment of patients infected with hepatitis C virus genotype 4.~   "
129551|NCT01871649|"~     The investigators will perform a 22-week randomized, double-blind, placebo-controlled trial~     of golimumab + methotrexate (MTX) versus methotrexate alone in methotrexate-naïve patients~     with Psoriatic Arthritis (PsA). Afterwards, a 28 week open label phase with methotrexate~     alone is started. Golimumab will be discontinued.~      Hypotheses:~      First, the investigators hypothesize that initiation of a combination therapy with golimumab~     + MTX will be safe and superior to MTX alone in MTX-naïve PsA patients, as assessed by the~     percentage of patients achieving Disease Activity Score (the investigators hypothesize that~     more patients with the early combination treatment will respond (according to Disease~     Activity Score (DAS), American college of Rheumatology (ACR), or Psoriatic Arthritis Response~     Criteria (PsARC) responses) and achieve a state of Low Disease Activity (LDA) or Minimal~     Disease Activity (MDA) than patients on MTX alone.~      Third, the investigators hypothesize that a significant proportion of the patients will~     continue to benefit from this early aggressive treatment initiation even after stopping~     golimumab treatment.~   "
129552|NCT01871636|"~     Conventional techniques of endoscopic mucosal resection (EMR) by snare resection do usually~     not achieve resection of gastrointestinal mucosal neoplastic lesions larger than 1 cm in~     diameter in a single piece. Complete R0 resection cannot be histologically confirmed. In~     contrast to EMR the technique of endoscopic submucosal dissection (ESD) allows en-bloc~     resection even of large neoplastic lesions. The waterjet-assisted ESD technology (WESD)~     allows pressure controlled injection of fluids through the tip of a recently developed~     HybridKnife®. Submucosal injection, circumferential cutting and dissection of lesions as well~     as coagulation of bleeding sources can be performed with the same device without need for~     changing the instrument. Our group reported on effective en-bloc resection of esophageal~     areas in all of 14 cases of an Erlangen porcine model. We subsequently compared WESD with EMR~     of predefined esophageal mucosal lesions in anesthetizised pigs in a randomized controlled~     trial. The results demonstrated that WESD more frequently achieved a complete resection with~     a significantly lower number of specimen. WESD caused no perforations and bleedings could be~     endoscopically managed during the procedure. In addition we recently reported on this~     technology in a first clinical trial on WESD for early Barrett`s neoplasia . The results~     indicated that WESD can be safely and effectively performed in the esophagus.~      Therefore the primary objective of this study is to compare the R0 resection rate of ESD and~     EMR for visible lesions of HIgh grade intraepithelial neoplasia (HGIN) or esophageal~     adenocarcinoma (EAC). Secondary objectives are related to completeness of resection, safety~     of the procedures, the medium term outcome and comparison of costs.~   "
129553|NCT01871623|"~     Le Fort I osteotomy is often used in orthognathic surgery for patients to solve midface~     retrusion. It is known that post-surgical stability of Le Fort I osteotomy can be influenced~     by single jaw or bimaxillary procedures, fixation techniques or interpositional grafting. In~     patients with cleft lip and palate, the postoperative instability of Le Fort I osteotomy can~     be even worse due to scar tissue resulted from palate surgery. Segmental LeFort I osteotomy~     is another useful surgical modifications that can be easily done through the alveolar cleft.~     It is performed to allow the correction of differences in the occlusal planes, correction of~     transverse discrepancy or to facilitate an optimal occlusion. The most important benefits is~     that the alveolar cleft in patients who have not had alveolar bone graft surgery or failed to~     have successful result can be narrow down or even closed by approximation of two separating~     alveolar segments. However, there are limited previous studies comparing the stability of~     segmental versus one-piece Le Fort I osteotomy especially in patients with cleft. It is our~     aim to investigate whether one-piece Le Fort I osteotomy or segmental Le Fort I osteotomy can~     provide a better stability after surgery.~   "
129554|NCT01871610|"~     There will be 200 participants, who aged 30 years or older with TBI in 1,5,10,15 years ago~     and GCS=13-15 will be recruited. Another group of 200 participants with the same age and~     gender and without TBI will be recruited as the controls. All of them will undergo AD8~     questionnaire for dementia screening and APOE4 genotyping. Further CASI and CDR will be~     tested for the confirmation of dementia diagnosis for the individuals with AD8 scaore >/=2.~     10 TBI with dementia, 20 TBI without dementia and 10 controls will be selected randomly for~     AV45 amylid PET study.~      There will also be 10 participants without traumatic brain injury and interested in this~     study, aged 55 years or older better.~   "
129555|NCT01871597|"~     Video assisted thoracoscopic surgery (VATS) anatomical lung resections (lobectomy or~     pneumonectomy) provide an effective minimally invasive treatment for stage 1 lung cancer.~      Currently, a minority of anatomical pulmonary resections are being performed by VATS (15%)~     (6). The technical difficulty and danger of VATS lobectomy is related to pulmonary arterial~     branch manipulation and this is the main limitation of many thoracic surgeons regarding the~     adoption of VATS lobectomy. We believe that if we can decrease the manipulation required by~     the surgeon on the pulmonary arterial branch, we can make these procedures safe and therefore~     more prevalent for anatomical pulmonary resections.~   "
129557|NCT01871571|"~     This phase II trial studies how well bevacizumab, fluorouracil, leucovorin calcium, and~     oxaliplatin before surgery works in treating patients with stage II-III rectal cancer.~     Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some~     block the ability of tumor to grow and spread. Others find tumor cells and help kill them or~     carry tumor-killing substances to them. Drugs used in chemotherapy, such as fluorouracil,~     leucovorin calcium, and oxaliplatin, work in different ways to stop the growth of tumor~     cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab~     together with fluorouracil, leucovorin calcium, and oxaliplatin may be an effective treatment~     for rectal cancer.~   "
129558|NCT01871558|"~     To compare a therapeutic strategy combining vildagliptin+metformin + Basal Insulin versus~     SU+metformin + Basal Insulin on the incidence of hypoglycemic events over 24 weeks.~   "
129559|NCT01871545|"~     The incidence of hepatocellular carcinoma (HCC) has recently increased in the United States.~     Although imaging plays a major role in HCC screening and staging, the possibility of~     predicting HCC tumor grade, aggressiveness, angiogenesis and hypoxia with imaging are unmet~     needs. In addition, new antiangiogenic drugs now available to treat advanced HCC necessitate~     the use of new imaging criteria beyond size. The investigators would like to develop and~     validate non-invasive magnetic resonance imaging (MRI) methods based on advanced~     diffusion-weighted imaging (DWI), MR Elastography, BOLD (blood oxygen level dependent) MRI~     and perfusion-weighted imaging (PWI, using gadolinium contrast) to be used as non-invasive~     markers of major histopathologic features of HCC, and to predict and assess early response of~     HCC to systemic therapy. The investigators also would like to develop quality control tools~     to improve the quality and decrease variability of quantitative MRI metrics. These techniques~     combined could represent non-invasive correlates of histologic findings in HCC, could enable~     individualized therapy, and provide prognosis in patients with HCC.~   "
129560|NCT01871532|"~     This is a prospective, multicenter, open-label, comparative and parallel-group study of~     ovulation induction evaluating tailoring of Recombinant follicle stimulating hormone (FSH)~     treatment using the Gonal-f® prefilled pen in World Health Organization (WHO) Type 2~     anovulatory subjects who have previously failed to conceive with clomifene treatment.~   "
129561|NCT01871519|"~     The study objective is to collect and report 12-month outcomes pertaining to activities of~     daily living, quality of life, and safety parameters in a Medicare population to be treated~     with balloon kyphoplasty in the treatment of painful, acute, vertebral body compression~     fractures (VCFs) associated with either osteoporosis or cancer. The primary objective is to~     show statistically significant improvement from baseline in the four co-primary endpoints~     (SF-36v2, PCS, EQ-5D, NRS back pain and ODI) at 3-months; study success will be declared if~     the primary objective is met. New radiographic fractures, non-surgical management received,~     VCF-related healthcare resource utilization, and vertebral body height restoration data will~     also be collected.~   "
129562|NCT01871506|"~     There are currently over 11 million cancer survivors in the U.S. and survival rates are~     increasing. Unfortunately, 10-30% of cancer patients are current smokers at the time of~     diagnosis, and many of these patients have elevated socioeconomic, medical, and psychosocial~     vulnerabilities. Documented risks associated with continued smoking following cancer~     diagnosis include decreased survival time; increased complications from surgery, radiation,~     and chemotherapy; and increased risk of second primary tumors. U.S. Department of Health &~     Human Services Public Health Service evidence-based tobacco treatment guidelines exist but~     have not been integrated into the cancer setting. This is a tremendous missed opportunity to~     address a modifiable risk factor. In recognition of this treatment gap, the National Cancer~     Institute (NCI) sponsored a conference in 2009 to address how to increase the readiness and~     capacity for delivery of tobacco treatment in Cancer Centers. The American Society of~     Clinical Oncology (ASCO) recommends identification, advice, and counseling of all smokers by~     their second oncology visit as a core quality indicator; however, currently only half of~     patients report being asked about tobacco use.~      Specific Aim: To conduct a randomized controlled comparative effectiveness trial of two~     strategies to promote smoking cessation in suspected or newly diagnosed cancer patients.~      Study Design: A multi-site randomized controlled comparative effectiveness trial will enroll~     295 current smokers with suspected or newly diagnosed melanoma, lymphoma, thoracic, breast,~     genitourinary, gastrointestinal, head and neck, or gynecologic cancer. Participants will be~     randomly assigned to receive Intensive Counseling (IC) or Standard Care (SC). Both groups~     will receive an initial motivational counseling session and 3 weekly follow-up counseling~     sessions with a tobacco treatment counselor, conducted in-person or by telephone. The IC arm~     has the option to also receive:~        -  Smoking Cessation Medication: Up to a 12-week supply of FDA approved smoking cessation~          medication (Varenicline, bupropion, or combination NRT) at no cost to the participant.~        -  Extended Counseling: An additional 4 biweekly and 3 monthly proactive counseling~          sessions with a tobacco treatment counselor (total of 11 counseling contacts).~      All participants will complete 1 baseline and 2 follow-up surveys, at 3 and 6 months.~     Self-reported abstinence will be biochemically confirmed at 3 and 6 months.~   "
129563|NCT01871493|"~     The main purpose of this study is to evaluate how the body absorbs and removes LY2605541,~     insulin lispro, and a mixture of both from the blood. The study has two parts. Participants~     may enroll in only one part. Each part has four treatment periods in a fixed order. The study~     will last approximately 8 weeks, not including screening. Screening is required within 28~     days prior to the start of the study.~   "
129564|NCT01871480|"~     Lung cancer is the most common cancer worldwide, non-small cell lung cancer (NSCLC) comprises~     about 85% of all lung cancer cases, which is the leading cause of cancer mortality, and~     adenocarcinoma is the most prevalent subtype. Gefitinib showed lower efficiency of treatment~     as second or third-line in patients with advanced adenocarcinoma NSCLC. It is necessary to~     further improve the efficiency of treatment in patients with advanced NSCLC. Immunotherapy~     with cytokine-induced killer cells (CIK) may improve tumor control and survival, as well as a~     better quality of life. This study is to evaluate the efficacy of Autologous CIK Transfusion~     plus Gefitinib for advanced, recurrence, metastatic adenocarcinoma NSCLC.~   "
129565|NCT01871467|"~     Previous studies have demonstrated a deficiency of blood dendritic cells in patients with~     kidney disease that is associated with the development of viral infections after kidney~     transplantation. We plan to test the ability of sargramostim to increase blood dendritic cell~     levels in patients with kidney disease in the hopes of developing new therapies to prevent~     viral infections after kidney transplantation.~   "
129566|NCT01871454|"~     The objective of this prospective phase II protocol is to assess the toxicity and efficacy of~     pentoxifylline and SABR in the re-treatment of recurrent or new lung cancers~   "
129791|NCT01868503|"~     This phase II trial studies how well lapatinib ditosylate and radiation therapy work in~     treating patients with locally advanced or locally recurrent breast cancer. Lapatinib~     ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Radiation therapy uses high energy x rays to kill tumor cells. Giving lapatinib~     ditosylate together with radiation therapy may be an effective treatment for breast cancer.~   "
129792|NCT01868490|"~     Cytokine-induced killer (CIK) cells exhibit high proliferation rate and cytotoxic activity in~     vitro. The major effector cells are the CD3+CD56+ subset. The cytolytic activity of CIK cells~     being independent of MHC restriction implies feasibility in using CIK cells allogeneic to the~     tumors. Experiments to block the MHC class-I and -II pathways on tumors-RNA transfected DCs~     showed that only MHC class-I blocking led to a significant reduction of heterogeneous CIK~     cells cytotoxicity after the co-culture. The safety of CIK cells was demonstrated by the lack~     of cytotoxicity toward autologous as well as allogeneic normal cells. Co-culture of CIK cells~     with dendritic cells (DCs) has been reported by us and others in a myriad of cancer (e.g.,~     cholangiocarcinoma, osteosarcoma, glioblastoma multiforme, multiple myeloma, hepatocellular~     carcinoma, pancreatic carcinoma, renal & colon carcinoma, murine leukemia & lymphoma showing~     enhancement of anti-tumor cytotoxicity of CIK cell in all. The co-culture of CIK cells with~     DCs were reported to decrease the number of professional regulatory/ suppressor T cells~     (Treg, CD4+CD25+ cells) and decrease the secretion of IL-10, an immune suppressor cytokine,~     whereas the cytotoxic activity against target cells increased.~      We have recently brought CIK cells through the preclinical phase (animal study) of human~     cholangiocarcinoma treatment. Cholangiocarcinoma (CCA), is a bile duct epithelial cancer~     endemic in the Northeast of Thailand, with an increasing incidence discernible in Europe and~     North America. Conventional treatments including surgery, chemotherapy, and radiation do not~     bring satisfactory survival due to anatomic location, presence of metastases, and high~     recurrent rates. These unsatisfactory outcomes urge to search innovative treatments such as~     immunotherapy. We reported the safety and efficacy of CIK cells in SCID mice model for~     cholangiocarcinoma. Several conditions of human CIK cells were examined using ex vivo~     cytotoxic assay and SCID mice pre-inoculated with human cholangiocarcinoma cells. We~     monitored the ex vivo cytotoxicity, tumor sizes and immunohistochemistry. Optimal tumor~     suppression was observed when CIK cells were pre-exposed to dendritic cells (DCs).~     Tumor-infiltrating human CD3+ cells were observed from day 2 - 14, but not in normal tissues~     elsewhere. These altogether indicated the specific homing of CIK cells to tumor mass. All~     animals did not exhibit any noticeable adverse reaction from the CIK treatments. The~     CD3+CD56+ cells are logical candidates for clinical trial while the DC-co-cultured CIK cells~     produced similar efficacy and more feasible for clinical application.~      With a complete array of in vitro and in vivo study, the next rational step is moving forward~     to phase I/II clinical trials for a number of specified solid tumors (i.e.,~     cholangiocarcinoma, osteosarcoma, and glioblastoma multiforme, nueroblastoma) using the~     optimized autologous CIK cells. Subjects without prior exposure to or weaned for at least 3~     months from chemotherapy can be recruited to maintain the integrity of their immunological~     system, a critical factor for a successful immunotherapy.~   "
129567|NCT01871441|"~     This phase II trial studies how well haploidentical donor hematopoietic stem cell transplant~     works in treating patients with hematologic malignancies. Giving chemotherapy and total-body~     irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It may~     also stop the patient's immune system from rejecting the donor's stem cells. Giving an~     infusion of the donor's T cells (donor lymphocyte infusion) may replace the patient's immune~     cells and help destroy any remaining cancer cells. When the stem cells from a related donor,~     that closely matches the patient's blood, are infused into the patient they may help the~     patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.~   "
129568|NCT01871428|"~     This multicenter, randomized, double-blind, placebo-controlled study will evaluate the~     efficacy, safety and tolerability of aleglitazar monotherapy in patients with Type 2 diabetes~     mellitus who are drug-naïve to anti-hyperglycemic therapy. Patients will be randomized to~     receive either aleglitazar 150 mcg orally daily or placebo for 26 weeks.~   "
129569|NCT01871415|"~     This multicenter, randomized, double-blind, placebo-controlled study will evaluate the~     efficacy, safety and tolerability of aleglitazar in combination with metformin in patients~     with Type 2 diabetes mellitus who are inadequately controlled with metformin monotherapy.~     Patients will be randomized to receive either aleglitazar 150 mcg orally daily or placebo for~     26 weeks in combination with their pre-existing metformin regimen and dose.~   "
129570|NCT01871402|"~     This Phase 3 study has been designed to determine and compare the efficacy and safety of~     000-0551 Lotion and Vehicle Lotion applied twice daily for two weeks in subjects with plaque~     psoriasis.~   "
129571|NCT01871389|"~     Vitamin D deficiency is common after bariatric surgery. This study is designed to determine~     if a high dose monthly supplement of vitamin D 3 will be effective in helping improve vitamin~     D status after surgery such as gastric bypass. Bariatric surgery subjects taking monthly high~     dose cholecalciferol supplements in addition to the standard vitamin D protocol will have a~     significant rise in serum vitamin D levels compared to the subjects taking only the usual~     vitamin D protocol.~   "
129572|NCT01871376|"~     To evaluate the efficacy and safety of intravitreal aflibercept injection in the treatment of~     PCV~   "
129573|NCT01871363|"~     Pathological complete response, (pCR) correlates with a favourable overall prognosis in~     locally advanced rectal cancer patients underwent preoperative chemoradiation, so obtaining a~     pCR might be beneficial. The aim of the study is to investigate safety and efficacy of~     preoperative IMRT combined with bevacizumab and capecitabine. primary endpoint is~     pathological complete remission rate.~   "
129574|NCT01871350|"~     Weight loss and muscle wasting commonly occurs in patients with cancer, negatively~     influencing their quality of life, treatment response and survival. Weight loss has been~     reported as a side effect of chemotherapy treatment in cancer. Weight changes may be the~     consequence of energy imbalance and disturbances in protein metabolism (through different~     factors linked with chemotherapy), such as reduced caloric and protein intake (partly related~     to depression), poor treatment tolerance, hormonal alterations, systemic inflammation etc.~     This results in body composition modiﬁcations in favor of fat gain and/or lean body mass loss~     in early stage cancer and loss of both fat mass and lean mass in advanced cancer. Depletion~     of lean tissue in cancer patients is related to short survival, and decreased skeletal muscle~     mass and function may result in fatigue and inactivity, which contributes to fat mass changes~     and can be responsible for chemo-toxicity and increased mortality.~      Gains in muscle mass are difficult to achieve in cancer unless specific metabolic~     abnormalities are targeted. Recently, the investigators observed that essential amino acid~     mixtures (EAA) are able to induce protein anabolism in patients with stage III and IV~     non-small cell lung cancer. Previous experimental research and clinical studies in cachectic~     conditions (including cancer) indicate that polyunsaturated fatty acids (PUFA) are able to~     attenuate protein degradation by improving the anabolic response to feeding and by decreasing~     the acute phase response. Eicosapentaenoic acid (EPA) (in combination with docosahexaenoic~     acid (DHA)) has been shown to effectively inhibit weight loss in several disease states;~     however, weight and muscle mass gain was not present or minimal. Recent studies examining the~     effect of fish oil supplementation in relation to chemotherapy have been inconclusive but~     found potential beneficial effects on physical performance and increased efficacy of~     first-line chemotherapy in patients with non-small cell lung cancer.~      It is the investigators' hypothesis that supplementation with milk protein (containing~     essential amino acids) carbohydrate (CHO) mixture in combination with fish oil~     supplementation will target the metabolic alterations in cancer patients receiving~     chemotherapy, attenuating the negative effects of chemotherapy on gut function, muscle mass~     and muscle function, and cognition; and leading to reduced toxicity from chemotherapy.~   "
129575|NCT01871337|"~     This study will examine whether the Paula method is an effective treatment for UI and the~     correlating LUTD symptoms. We assume that the Paula method, a simple, non-aerobic exercise~     method that significantly decreased urinary incontinence in women with MIX in two randomized~     controlled trials, would also be effective in Multiple Sclerosis (MS) patients with UI. The~     secondary aim is to evaluate the effectiveness in terms of MS general physical functioning,~     quality of life and sexual function and to detect adherence and continuity six months post~     intervention.~   "
129576|NCT01871324|"~     The purpose of this study is to compare the influence of an intervention program especially~     designed to young ultra orthodox men that were diagnosed with diabetes type one.~   "
129577|NCT01871311|"~     The purpose of this study is to determine the recommended Phase II dose of nilotinib when~     used in combination with cetuximab in the treatment of patients with recurrent and/or~     metastatic Kras wildtype colorectal cancer or squamous cell carcinoma of the head and neck.~   "
129578|NCT01871298|"~     The purpose of this exploratory study is to examine factors associated with frequency and~     type of internet and mobile technology use among illegal drug users, specifically use of~     internet and text-messaging to obtain health care information and engage in health care~     utilization, specifically human immunodeficiency virus (HIV) prevention and treatment~     services. We will target high drug activity neighborhoods in New York City and enroll~     participants recruited through targeted street outreach. All participants (n=336) will~     undergo an audio computer-assisted self-interview (ACASI) that will assess sociodemographics,~     health care access and utilization, sex/drug use behavior, health status, and characteristics~     of general and health-related internet/mobile technology use including factors that promote~     or hinder use. Participants identified as using the internet ≥1/month (n=151) will return for~     a 4-week ACASI to report on use of the pilot website (which will largely display information~     currently available in the community in print/ pamphlet/ video form).~   "
129579|NCT01871285|"~     The primary aim of this study is to determine if chronic pain subjects on around-the-clock~     opioids who are receiving 100 to 220 mg oral morphine sulfate equivalent (MSE) can be safely~     transitioned on to buprenorphine hydrochloride (HCl) buccal film at 50% of their MSE dose~     without inducing opioid withdrawal or reversing analgesic effects.~   "
129580|NCT01871272|"~     PURPOSE: To investigate the natural time course of patient-reported outcomes after meniscus~     surgery and identify factors associated with good and bad outcome after surgery.~   "
129581|NCT01871259|"~     To relate two different predictive values of sleep apnea: the STOP score (snoring while~     sleeping, daytime tiredness, observed breathing stoppages, and high blood pressure) and the~     estimated respiratory disturbance index (eRDI) with the occurrence of apnea-hypopnea during~     propofol sedation,thirty four middle-aged male patients who underwent urologic surgery under~     spinal anaesthesia will be enrolled. Before surgery, patients will be asked to complete a~     STOP-questionnaire. The eRDI will be calculated using the modified Mallampati's grade, tonsil~     grade, and the body mass index. After performing spinal anaesthesia, propofol will be infused~     and adjusted to BIS 70-75. An ApneaLinkTM, which measures airflow through a nasal cannula,~     will be then applied to estimate the level of apnea-hypopnea.~   "
129582|NCT01871246|"~     People with chronic obstructive pulmonary disease (COPD) are very sedentary and efforts to~     establish an active lifestyle are challenging because of periodic acute exacerbations of COPD~     that interrupt physical activity patterns and contribute to further decline in physical~     activity. The purpose of this preliminary research is to learn more about the experience of~     acute exacerbations of COPD (AECOPD) from the perspective of the patient and his/her family~     and to learn how AECOPDs affect physical activity.~   "
129583|NCT01871233|"~     The Extended Access Program (EAP) is a managed access programme for Perampanel. The main~     objective of this EAP is to ensure that patients participating in studies E2007-A001-207,~     E2007-G000-307, or E2007-G000-235 continue to have access to perampanel until such time~     perampanel tablets become commercially available for the treatment of Partial Onset Seizures~     (POS) in the country in which they reside. This EAP will consist of 2 phases:~        -  Screening: The patient will start the program once the Screening assessments are~          completed and the patient is qualified for participation.~        -  Treatment: Additional assessments, physical examinations, and dosage changes will be~          clinically determined by the treating physician.~      Patients will enter this program on the same dose of perampanel that they were receiving at~     the end of their participation in previous study. Doses of perampanel and of concomitant~     anti-epileptic drugs (AEDs) can be adjusted (i.e., added,removed, or changed in dose) based~     on clinical judgment.~      Treatment will be prescribed as long as clinically appropriate according to the judgement of~     the treating physician and the approved Summary of Product Characteristics (SmPC).~      The program will complete in a staggered fashion, country by country, as and when perampanel~     becomes commercially available for the treatment of POS in each country.~   "
129584|NCT01871220|"~     The purpose of this study is to compare the effect of two different implant abutment designs~     on gum tissue volume changes over time after implant placement.~   "
129585|NCT01871207|"~     Some studies have recently shown that the concentration of erythropoietin in the vitreous~     humor of diabetic patients suffering from diabetic retinopathy is higher than non-diabetic~     patients. It was reported a higher concentration of erythropoietin in vitreous humor than~     blood, indicating a local production. In some cases it was also found a positive association~     between concentrations of Erythropoietin and Vascular Endothelial Growth Factor (VEGF). Both~     of these factors, erythropoietin and VEGF, show important angiogenic activity and may play a~     role in the development of diabetic retinopathy.~      This study enrolled type 2 diabetic patients with PDR who had to undergo vitrectomy during~     the period May 2011-January 2012 at the Unit of Ophthalmology, A.O. Civil Hospital and~     University of Brescia. Inclusion criteria were the following: type 2 diabetes, age greater~     than 18 years, and PDR; exclusion criteria were: age less than 18 years, type 1 diabetes,~     initial DR, PDR patients not requiring surgery, previous vitrectomy in the eye under~     examination or other ophthalmic surgery or laser therapy within the previous 3 months.~      Non-diabetic patients who underwent vitrectomy for macular hole or pucker represented the~     control group (CTRLs); their inclusion criteria were: age greater than 18 years and the~     presence of macular pucker or macular hole requiring vitrectomy. Exclusion criteria were: age~     less than 18 years, diagnosis of diabetes mellitus, and previous vitrectomy in the eye under~     examination or other ophthalmic surgery or laser therapy within the previous 3 months. All~     patients underwent a complete ophthalmologic examination (visual acuity, slit lamp,~     tonometry, fluorescein retinal angiography, and optical coherence tomography -OCT-). Informed~     consent was obtained from all patients after a detailed description of the aims and~     procedures of the study.~      The following data were recorded for each patient:~        1. Population: age (years), sex (M/F);~        2. Clinical: diabetes (Absent or Type 2); time since initial diagnosis of diabetes (years);~          type of therapy for DM: diet, oral hypoglycaemic agents, mixed (oral agents and insulin,~          insulin); hypertension (defined as systolic blood pressure > 140 and diastolic blood~          pressure > 90 mmHg or on antihypertensive drugs); current (Yes/No) antihypertensive~          therapy; use of angiotensin II receptor blockers (ARB) or angiotensin converting enzyme~          inhibitors (ACE-i); presence of hypercholesterolaemia, comorbidities, therapy with~          statins (Yes/No), anticoagulants (Yes/No), antiplatelet therapy (Yes/No); other~          therapies performed, smoking (non-smoker, active smoker); complications of diabetes~          mellitus present at the time of evaluation (heart disease, nephropathy, neuropathy);~        3. Ocular: eye (OD/OS); visual acuity; presence and grade of diabetic retinopathy; presence~          of emovitreo; presence of diabetic macular oedema; presence of cataract or lens implant;~          intervention with phacoemulsification during vitrectomy; presence of retinal diseases,~          or any other concomitant eye diseases; performance of previous retinal laser therapy,~          intravitreal injection of Avastin before the vitrectomy;~        4. Biochemical: Haemoglobin (g/dL); glucose (mg/dL); glycated haemoglobin (%); platelets~          (N/mmc); creatinine (mg/dL); albuminuria (mg/day), creatinine clearance (mL/min),~          calculated by the Modification of Diet in Renal Disease (MDRD) formula; total~          cholesterol (mg/dL); HDL and LDL; triglycerides (mg/dL).~      All patients underwent a 23- or 25-gauge pars plana vitrectomy. The primary outcome of the~     study was the measurement of EPO and VEGF concentrations in serum and vitreous and aqueous~     humor. Blood samples, taken before surgery, were centrifuged at 3000 rpm for 10 minutes to~     separate the serum fraction, which was stored at -80°C. Aqueous and vitreous humor were taken~     during the surgery and immediately frozen at -80°C. Both EPO and VEGF concentrations were~     measured in serum and vitreous humor; however, owing to the small amount of sample, only EPO~     concentrations were determined in aqueous humor. EPO was assayed by radioimmunoassay~     (Immulite EPO 200, Siemens), with the lowest detection limit of 1.0 mIU/mL. VEGF was assayed~     by ELISA (Human VEGF Immunoassay, R & D Systems Europe, Abingdon, UK) with a lower limit of~     detection of 10.0 pg/mL. VEGF concentrations below the lower limit of detection were set to 5~     pg/mL to perform statistical analysis. VEGF values above 2000 pg/mL were set to 2500 pg/mL;~     statistical tests were also performed after deleting the data above 2000 pg/mL.~   "
129586|NCT01871194|"~     This study aims to evaluate the use of rivaroxaban and its short term safety when used by~     patients for the new indications of prevention of stroke and systemic embolism in patients~     with non-valvular atrial fibrillation, treatment of deep vein thrombosis (DVT) and pulmonary~     embolism (PE) and prevention of recurrent DVT and PE. Any adult patient started by their care~     team on rivaroxaban or an alternative anticoagulant for the specified indications during the~     study period will be eligible to take part. A questionnaire will be completed by the care~     team of each patient at the start of treatment and again 12 weeks later. The care team will~     complete the questionnaires using information from the patient's medical notes, not by asking~     the patient directly. If a participant has an adverse event during the 12 week period, we may~     ask the patient's care team to fill out a further follow up questionnaire. No other~     examinations or tests will be performed. Patients will only be recruited to the study after~     the clinical decision to prescribe rivaroxaban or an alternative anticoagulant has been made,~     so that prescribing behaviour is not altered by the study. It is an observational,~     non-interventional study covering the whole of England and Wales.~   "
129587|NCT01871181|"~     Injection of local anesthetic drugs is an effective way to freeze (block) nerves to achieve~     loss of sensation during surgery and satisfactory pain control afterwards. Many studies have~     shown that nerve block is associated with higher degree of success in controlling pain after~     open inguinal hernia repair. Nerve block can be administered by a single injection with a~     long acting local anesthetic agent using ultrasound guidance. This study is to compare~     different techniques for freezing the nerves responsible for pain after open inguinal hernia~     repair. Patients will be randomized to one of two groups. In the first group, participants~     will receive ultrasound-guided nerve block following induction of general anesthesia but~     prior to surgical procedure. In the second group, participants will receive local anesthetic~     injection directly into the wound by the surgeon prior to closure. The investigators will~     assess the level of pain control for 48 hours after the surgical procedure. Patients will be~     provided with additional medications for pain relief if necessary. The investigators will~     also contact participants to follow-up with regard to possible chronic groin pain after 3~     months following the surgical procedure.~   "
129588|NCT01871168|"~     The purpose of this study is to establish an alternative method of postoperative pain control~     to the current standard of practice, patient-controlled analgesia with intravenous opioids,~     for patients undergoing a major major abdominal surgery at the University of Alberta~     Hospital. The primary objective is to determine whether a continuous transversus abdominis~     plane (TAP) block, run until the third postoperative day, will reduce the amount of~     intravenous morphine required. Additionally, the investigators propose to measure the amount~     of local anesthetic (lidocaine) in the blood during this time frame to provide patient safety~     data for this procedure. This will be a prospective controlled randomized double-blind~     clinical trial. The patients, anesthesiologists and staff providing post operative care will~     be blinded to group assignment. Patients will be randomized by sealed envelopes.~   "
129589|NCT01871155|"~     The purpose of this study is to determine whether a novel edible nutritious gel for patients~     with chewing and swallowing difficulties, Nutri-jelly, is effective in improving the quality~     of life of head and neck cancer patients while undergoing conventional radiotherapy.~   "
129823|NCT01868087|"~     The purpose of this study is determine if using Impact Advanced Recovery® before and after RC~     surgery helps reduce surgical complications.~   "
129824|NCT01868074|"~     This research is being conducted to determine whether use of an arch-supporting insole during~     pregnancy prevents alterations in foot structure and lower limb rotational movements. The~     investigators hypothesize that the arch collapse during pregnancy will be significantly~     reduced in women randomized to use the supportive insole compared with women randomized to~     the control group.~   "
129590|NCT01871142|"~     In low oxygen environments, such as high-altitude, some adults may become ill and suffer from~     acute mountain sickness. Further, all adults will find that exercising becomes much more~     difficult when compared with exercise at lower altitudes (e.g. sea-level). The purpose of~     this investigation is to study the effects of a new medicine called Aes-103. A company called~     AesRx, LLC makes this medicine. The active ingredient in the medicine is~     5-Hydroxymethyl-2-Furfural (5HMF), a naturally occurring substance that can be found in~     coffee, honey, dried fruits, fruit juices, malt, barley, Balsamic vinegar and caramel.The~     investigators believe that Aes-103 may help people adjust to high-altitude quickly and~     prevent them from becoming ill. The purpose of the study is to determine if Aes-103 will~     promote endurance performance in low oxygen environments in healthy adult humans.~      Aes-103 is currently being investigated by AesRx, LLC (Newton, MA) in collaboration with the~     National Heart, Lung and Blood Institute of the NIH (Bethesda, MD) as a potential~     anti-sickling agent in sickle cell disease. Sickle-cell disease is characterized by problems~     in blood that prevent blood cells from carrying oxygen. Aes-103 might be able to help blood~     cells carry more oxygen. It is for this reason that the investigators in this study believe~     Aes-103 might help people adjust to high-altitude quickly.~      There are no known special safety considerations with the active ingredient in Aes-103~     (5-HMF). In recent, placebo controlled, clinical safety tests, Aes-103 was given in single~     doses of 300 mg, 1000 mg,2000 mg and 4000 mg to healthy normal volunteers. Additionally, the~     toxicological effects of Aes-103 have been studied when given acutely, sub-acutely, and~     chronically in rodents, and for up to 28 days in dogs. Based on these safety studies, single~     doses of Aes-103 are expected to have no significant negative/toxicological effect at the~     doses being evaluated in this study.~   "
129591|NCT01871129|"~     The postoperative removal of intubation tube induces a noticeable sympathic response and~     increase of blood pressure. The risk of complications is especially elevated with the~     patients having cardiac surgery. Though sedation inhibits the sympathetic responses to~     extubation, according to the current protocol the propofol infusion has to be discontinued~     well before extubation because of its inhibitory effects on breathing centers.~      Dexmedetomidine is relatively new anesthesia drug. Dexmedetomidine is unique in its~     characteristic that it does not have the paralyzing effect on breathing. The aim of our study~     is to work out whether dexmedetomidine-extended propofol sedation over the extubation~     diminishes the aforementioned harmful effects of the extubation procedure.~      Study design is prospective double-blinded randomized study. The investigators compare two~     groups of 25 patients (total 50), who are of 60-90 years of age and are having either aortic~     valve surgery or the mentioned accompanied with cardiopulmonary bypass operation. The first~     group receives dexmedetomidine infusion and the other receives placebo infusion after the end~     of propofol infusion.~      The specific goal of the study is to figure what haemodynamic - mostly blood pressure related~     - changes can be observed when the postoperatively cut propofol infusion is continued with~     dexmedetomidine over the extubation procedure.~      Our hypothesis is that by using dexmedetomidine supplemented sedation the normally notifiable~     peak in blood pressure may be avoided.~      The study will be carried out completely in Cardiac ICU in Tampere University Hospital.~   "
129592|NCT01871116|"~     This research is being done to assess the effectiveness of a weight loss program in women~     with early stage breast cancer whose body mass index (BMI) is in the overweight or obese~     range (>25). Weight loss is beneficial in improving cardiovascular risk factors and overall~     health, but may also decrease the chance of breast cancer coming back. A weight loss~     counseling program was studied in a general population and was found to be effective to help~     reduce weight over a 2 year period.~      The main goal of this study is to determine if women with a recent diagnosis of early breast~     cancer will also lose weight with this program. To better understand the effect that weight~     loss has on women with breast cancer, we will compare the patterns in blood and breast tissue~     samples (tissue biopsies will be optional), and questionnaires evaluating different aspects~     of one's well-being, before and after a dietary intervention or no intervention.~   "
129593|NCT01871103|"~     Soft tissue reconstruction in the finger continues to evolve. The dorsum of the finger is a~     reliable flap donor site in reconstructive hand surgery because of its similar quality to the~     original. The dorsal homodigital island flap can be used as a reliable alternative for~     reconstructing small to moderate defects of the fingers. In this retrospective study, the~     investigators would evaluate the efficacy of the technique for tissue reconstruction in~     different regions of the finger, with an emphasis on sensibility, pain and donor site~     morbidity.~   "
129594|NCT01871090|"~     A prospective, post market, non-randomized study to evaluate the reduction in time to~     interrogation for patients with St. Jude Medical remote care compatible devices interrogated~     by the unpaired Merlin@home transmitter in the Emergency Department (ED). Two sites will~     enroll up to 100 patients total.~      Expected duration of the study is 6 months. Once enrolled the patient will participate in the~     study for the duration of the Emergency Department stay, until discharged or admitted to the~     hospital.~   "
129595|NCT01871077|"~     The purpose of this study is to evaluate safety and tolerability of the ophthalmic solution~     PRO-156 over the ocular surface of ophthalmologically healthy volunteers~   "
129596|NCT01871064|"~     This study will assess the residual neuromuscular blockade (NMB) Train-Of-Four (TOF) ratios~     at tracheal extubation when anesthesiologists have determined that full recovery of~     neuromuscular function has occurred using standard clinical criteria for participants whose~     non-depolarizing-induced NMB is either not reversed or reversed with an acetylcholinesterase~     inhibitor administered as per standard routine care.~   "
129597|NCT01871051|"~     This project was aimed to identify the risk factors associated with the occurrence of~     respiratory complications in post anesthesia care unit. The primary outcome was the composite~     measure of occurrence of complications in PACU. The components were apnea or hypopnea,~     laryngospasm, bronchospasm and prolonged oxygen requirement.~   "
129598|NCT01871038|"~     To determine the effectiveness of rotavirus vaccines, active surveillance will be conducted~     at two sites, Cincinnati Children's Hospital Medical Center (CCHMC) in Cincinnati, Ohio and~     the Medical University of South Carolina (MUSC) in Charleston, South Carolina.~      Children born on or after April 1, 2006 presenting to CCHMC as an inpatient or for a~     short-stay or Emergency Department (ED) visit with acute gastroenteritis (AGE) and/or fever~     will be approached for enrollment. Children will be eligible if they have vomiting and/or~     diarrhea less than or equal to 10 days duration. Data including demographic information,~     illness characteristics and socio-economic status will be collected from each patient. A~     sample of the patient's stool will be collected within 14 days of the onset of symptoms.~     Stool specimens will be tested for rotavirus antigen by Rotaclone at CCHMC. All rotavirus~     positive stool specimens will be typed for common G and P serotypes. Using the children~     identified with rotavirus as our cases and the children who were rotavirus negative as our~     controls, we will conduct a case control study to assess the effectiveness of rotavirus~     vaccines, in particular Rotarix.~   "
129599|NCT01871025|"~     To study the effects of early exercise training in hospitalized patients for Chronic~     Obstructive Pulmonary Disease exacerbation (COPD). Interventions are randomized. In one~     group, early exercise training (aerobic and strength) during hospitalization for COPD~     exacerbation followed by exercise training at home until 90 days to discharge and in the~     other the intervention is usual care. In both group, usual respiratory physiotherapy~     techniques during hospitalization and adequate physical activity recommendations have been~     included. The main variable is the presence of a new COPD exacerbation according to Global~     Initiative for COPD (GOLD guidelines) with a minimum of 12 months-follow up.~   "
129600|NCT01871012|"~     Total Knee Replacement (TKR) performed under general anesthesia is a common successful~     orthopedic procedure. Nonetheless, in elder patients with diabetes mellitus (DM) this~     procedure can present unique challenges to orthopedic surgeon and anesthesiologist alike.~     Many diabetic patients have clinical or subclinical neuropathy. Although there is no evidence~     that the neuropathy is exacerbated by neural blockade, recent studies have suggested that the~     peripheral nerves in diabetic patients may be more susceptible to trauma and local~     anaesthetic toxicity. Therefore, The investigators observe peripheral nerve blocks with~     ropivacaine on diabetic patients or non-diabetic patients undergoing TKR by assessing the~     management of intraoperation and the Postoperative Recovery and complications.~   "
129601|NCT01870999|"~     This study will evaluate the safety, tolerability, efficacy and pharmacokinetics of~     aripiprazole intramuscular (IM) depot multiple doses every 4 weeks in adult patients with~     schizophrenia.~   "
129602|NCT01870986|"~     This healthy volunteers study will evaluate 210 subjects who will receive a single~     sub-cutaneous dose of PF-06410293 or adalimumab (United States) or adalimumab (European~     Union). This study will involve sampling and pharmacokinetics evaluation of drug levels~     following administration of PF-06410293 and the licensed adalimumab products.~   "
129603|NCT01870973|"~     The purpose of this study is to evaluate patients with emergency pain and a sore (infected)~     tooth to determine if immediate root canal therapy is better at reducing pain, when compared~     to initial treatment with antibiotic and pain medication followed by root canal therapy. Each~     participant will be randomly assigned a number, which will determine if they will receive~     initial endodontic treatment that day or at a later date. Each participant will receive an~     anesthetic injection, pain medication and a prescription for an antibiotic. They will be~     asked to keep a diary to record their pain level after the injection and their pain levels~     and the amount and type of pain medication taken each day for the next 5 days. Participants~     who did not receive root canal therapy at the initial appointment will receive it after the 5~     day postoperative period. The pain levels and medication use will be compared between the~     treatment and nontreatment groups.~   "
129604|NCT01870960|"~     The main problem of using xenogenic bone in sinus floor elevation is the slow rate of~     absorption, which gives the percentages of vital bone low (20 to 30% depending on the study)~     in which the dental implant will be positioned However, osseointegration of the implant can~     be achieved only in vital bone. Enamel Matrix Derivative, through their angiogenic and~     osteogenic properties known, could promote bone healing during surgery sinus floor elevation~     by increasing the percentage of vital bone reformed, when added to xenografts.~   "
129605|NCT01870947|"~     This is an assisted exercise trial involving exercise on a stationary bike, brain imaging and~     DNA(genetics)sampling. The purpose of this study is to find out if performing a progressive,~     supervised assisted exercise program on a stationary bike improves quality of life, increases~     motivation to continue to exercise, improves dietary behavior and leads to sustained weight~     loss in women who have had early-stage endometrial cancer. Questionnaires will be used to~     assess exercise motivation and dietary behavior. Brain's responses to different visual images~     will also be assessed.~   "
129606|NCT01870934|"~     Diabetic foot ulcers are deep wounds that occur as a result of nerve damage in the feet~     (peripheral neuropathy). Amputation is a common consequence of diabetic foot ulcers;~     approximately 85% of all diabetes-related amputations are caused by foot ulcers. The ulcer~     treatment is extensive, resource demanding and highly specialized and necessitates~     involvement of patient, hospital and local in-home care personnel.~      The 3D photo optic camera project aims at a much more efficient and precise method for~     diagnosis and treatment of foot ulcers. The Department of Endocrinology and the section for~     LEAN and Innovation at Odense University Hospital has developed a prototype for a 3D camera~     that takes pictures and measurements of the ulcer that can provide the basis for correct~     diagnosis and treatment of the ulcer. The camera was developed in close cooperation with~     TECCLUSTER A/S, Svendborg Municipality, Team Online and ComMed.~   "
129607|NCT01870921|"~     A multicenter, single arm, open label, Phase IV study to evaluate safety and to describe the~     incidence of major cardiovascular events of ticagrelor in Chinese patients with acute~     coronary syndrome~   "
129608|NCT01870908|"~     This study is to evaluate the safety and the effectiveness of treatment with tacrolimus and~     biological agents.~   "
129609|NCT01870895|"~     To demonstrate the superiority of YM060 to a placebo in global assessment of relief of~     overall IBS symptoms and stool form normalization, and to evaluate safety in female patients~     with diarrhea-predominant irritable bowel syndrome (D-IBS).~   "
129610|NCT01870882|"~     The purpose of this study is to determine the feasibility and preliminary efficacy of~     attention training using a portable electronic device for opioid-dependent cocaine-users~     stabilized on methadone.~   "
129611|NCT01870856|"~     The purpose of this study is to evaluate the effect of contact lens lubricity on lid wiper~     epitheliopathy (LWE) in symptomatic contact lens wearers. LWE is defined as an alteration of~     that portion of the marginal conjunctival epithelium of the upper eyelid that wipes the~     ocular surface during blinking.~   "
129612|NCT01870843|"~     The purpose of this study is to evaluate the impact of escitalopram on quality of life and~     social functionality in patients with major depressive disorder with anxiety symptom.~   "
129613|NCT01870830|"~     The purpose of this study is to evaluate whether nocturnal breathing and sleep of patients~     with chronic obstructive pulmonary disease (COPD) are disturbed during a stay at moderate~     altitude.~   "
130118|NCT01864226|"~     This single-center, randomized, investigator/subject-blind, adaptive multiple ascending-dose,~     placebo-controlled study will evaluate the safety, tolerability, pharmacokinetics and~     pharmacodynamics of RO5545965 in healthy volunteers. Subjects will be randomized to receive~     either RO5545965 or matching placebo daily for 12 days.~   "
129614|NCT01870817|"~     After surgery for oesophageal (gullet) or gastric (stomach) cancer, patients are routinely~     fed by means of a small feeding tube into the intestine (jejunostomy, JEJ) while they are in~     hospital. Current practice is to stop feeding once the patient leaves hospital, although the~     tube is left in place for the first 6 weeks. Most patients lose weight after surgery and have~     to learn to adjust to new eating habits and behaviours. A few patients have the JEJ feed~     restarted because of nutritional problems and this requires a further inpatient stay.~      It is unknown whether every patient would benefit from this type of feeding at home. Previous~     studies have only assessed the value of JEJ feeding while patients are still in hospital.~     There is little known about the benefit of continuing JEJ feeding after discharge from~     hospital, although home feeding is not uncommon in other patient groups (eg. after a stroke).~      The proposed study will provide initial information on patients' well being by measuring~     quality of life and factors such as change in body weight and dietary intake following a~     period of home JEJ feeding after surgery. Subjects recruited into the study will be placed,~     randomly, into a control group who receive current nutritional care (based on dietary advice~     and oral nutritional supplement drinks) or an intervention group who will receive home JEJ~     feeding for 6 weeks after hospital discharge, in addition to current treatment.~      If subjects in the control group are experiencing problems eating at home, home feeding~     through the JEJ tube will be started as needed.~      The study will also examine how surgery and JEJ feeding at home impact on the patient and~     carer(s) by means of questionnaires and interviews conducted in the patients' home.~      Information obtained will assist in the design of a multicentre study. This intervention is~     considered important because it has the potential to benefit thousands of patients each year~     at a modest cost.~   "
129615|NCT01870804|"~     The aim of the project is to compare the nephro-protective effects of high-dose atorvastatin~     and high-dose rosuvastatin on the incidence of Contrast Induced-Acute Kidney Injury in~     patients with non-ST-elevation acute coronary syndromes scheduled for early invasive~     strategy.~   "
129616|NCT01870791|"~     The prognosis for patients with advanced oesophago-gastric cancer is poor. Approximately~     16,000 patients in the United Kingdom die from the disease. In spite of new chemotherapy~     regimens, the average survival for these patients is around 9 months from diagnosis.~      Omegaven is an infusion comprising omega-3 fish oils. There is evidence that omega-3 fish oil~     supplementation can improve general well-being and quality of life in patients receiving~     palliative chemotherapy for a number of different cancer types. It has also been suggested~     that omega-3 fish oil supplementation may reduce the toxicity of chemotherapy.~      This clinical trial aims to see whether the addition of Omegaven to EOX chemotherapy, the~     most widely used regimen for patients with advanced oesophago-gastric cancer, will make this~     drug regimen more effective at killing oesophago-gastric cancer cells, such that disease~     progression is delayed. Forty-five patients who have been diagnosed with advanced~     oesophago-gastric cancer will be recruited over a two year period to receive standard~     chemotherapy and omega-3 fish oil supplementation. The results in these 45 patients will be~     compared to a matched historical control group of patients who have received identical~     chemotherapy. If results suggest that the combination of EOX and Omegaven is sufficiently~     effective, tolerable and feasible then it will be the intention of the trial team to take the~     combination forward to treat patients with advanced oesophago-gastric cancer in a randomised~     study.~   "
129617|NCT01870778|"~     The purpose of the study was to evaluate the efficacy, safety and tolerability of intravenous~     infusion of serelaxin, when added to standard therapy, in acute heart failure (AHF) patients.~   "
129618|NCT01870765|"~     Bronchoscopy with broncho-alveolar lavage is a diagnostic tool in patients with pneumonia.~     Especially patients with acute or chronic pulmonary diseases are at risk of respiratory~     failure during or after bronchoscopy. It is known that in these cases bronchoscopy can be~     performed safely using non-invasive ventilation. It seems probable that high-flow oxygen,~     which is used in the treatment of patients with hypoxemic respiratory failure, is equally~     effective in preventing the development of respiratory failure during fiberoptic bronchoscopy~     while improving patient comfort. In this prospective randomised study the safety of high-flow~     oxygen is compared with non-invasive ventilation in patients with hypoxemic respiratory~     failure undergoing fiberoptic bronchoscopy.~   "
129619|NCT01870752|"~     Chemotherapy and radiation therapy for the treatment of cancer can compromise fertility.~     Ovarian tissue cryopreservation is an experimental strategy offered at The University of~     Pennsylvania to preserve future fertility (protocol 806062). The primary objective of this~     study is to determine the efficacy and safety of autologous transplantation of previously~     cryopreserved ovarian cortical tissue in patients who experience infertility or ovarian~     insufficiency after cancer treatments.~   "
129620|NCT01870739|"~     This was the first evaluation of the effects of LCZ696 on local and regional measures of~     aortic stiffness in subjects with mild to moderate hypertension and widened pulse pressure.~     The results of this exploratory study will help to understand the mechanism of action of~     LCZ696 and used to inform the design of future clinical studies with LCZ696 in subjects with~     cardiovascular diseases.~   "
129621|NCT01870726|"~     The study assessed the safety and the dose of the combination of INC280 and buparlisib~     (BKM120), as well as the anti-tumor activity of the combination, in patients with recurrent~     glioblastoma with PTEN mutations, homozygous deletion of PTEN or PTEN negative by IHC. In~     addition, the anti-tumor activity of INC280 single agent should have been assessed in~     patients with recurrent glioblastoma with c-Met alteration.~   "
129622|NCT01870713|"~     The purpose of this study is to reveal the key proteins involved in gastric bypassing surgery~     which may effect the decreased glucose in type 2 diabetes patietns, and evaluate standard~     remission rate as well as cost-benefit of gastric bypassing surgery for type 2 diabetes~     mellitus patients in China.~   "
129623|NCT01870700|"~     A double-blind, placebo Randomized Controlled Trial, To evaluate the effects of L. reuteri in~     adult patients with functional constipation.~   "
129624|NCT01870687|"~     The purpose of this study is to proof the efficacy and safety of 20 mg (2 tablets of 10 mg)~     VAC BNO 1095 film-coated tablets in patients suffering from cyclic mastodynia and PMS (pre~     menstrual syndrome).~   "
129625|NCT01870674|"~     Study to evaluate the safety/tolerability and pharmacokinetics/pharmacodynamics(PK/PD)of~     YH12852 after oral administration in healthy subjects~   "
129626|NCT01870661|"~     Comparison of peripheral IV catheters inserted by ultrasound using the long axis vs. the~     short axis technique. Our hypothesis is that long axis ultrasound placement will increase the~     longevity of the IV catheter.~   "
129627|NCT01870648|"~     The primary objective is to determine if the administration of a single dose of oral~     ondansetron (an anti-vomiting medication), compared to placebo, results in a reduction in~     intravenous (IV) rehydration therapy in children presenting for emergency department care~     with some dehydration, vomiting and diarrhea in Pakistan.~      SOME Dehydration is defined as 2 or more of the following signs and symptoms:~        -  Restlessness, irritability~        -  Sunken Eyes~        -  Drinks eagerly, thirsty~        -  Skin pinch goes back slowly~   "
129629|NCT01870622|"~     Most premature babies have difficulty breathing at birth and need help (resuscitation). The~     treatment for this is to gently inflate their lungs with a resuscitation device and a~     facemask. To gently inflate an infant's lungs the clinical team places a breathing tube in~     the windpipe and blow air into your baby's lung (puffs). With the first puffs the clinical~     team checks if the breathing tube is correctly placed within the windpipe. The investigators~     routinely use a detector which checks for exhaled carbon dioxide or the graphical display of~     waves forms of the infants breathing to check that the breathing tube position. However, the~     investigators do not know which one (exhaled carbon dioxide or the graphical display of waves~     forms) is better to check that the breathing tube position is correct and therefore the~     investigators would like to study them. The purpose of this study is to compare exhaled~     carbon dioxide detectors (ECO2 group) with the graphical display of waves forms (flow waves~     group) to provide us with information on how the investigators can help babies who struggle~     with breathing at birth.~   "
129630|NCT01870609|"~     This study is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study of~     defactinib (VS-6063) in subjects with malignant pleural mesothelioma (MPM) who have not~     progressed (confirmed partial response or stable disease) following ≥ 4 cycles of treatment~     with pemetrexed/cisplatin or pemetrexed/carboplatin. Prior to entry and randomization to the~     study, each subject must have tumor Merlin status(high or low) established by~     immunohistochemistry performed at a central laboratory. Subjects will be randomized in a 1:1~     ratio to receive oral VS-6063 400 mg twice per day, or matched placebo. Randomization will be~     stratified by tumor Merlin status (high versus low). Progression will be assessed both~     locally and by central review using the Response Evaluation Criteria In Solid Tumors (RECIST)~     Version 1.1. Subjects will continue to receive treatment until disease progression or other~     discontinuation criteria are met. Following documentation of nonfatal disease progression,~     all subjects will be followed for overall survival by telephone contact every 2 months until~     end of life or the close of the study.~   "
129631|NCT01870596|"~     This randomized phase II trial studies how well cytarabine with or without SCH 900776 works~     in treating adult patients with relapsed acute myeloid leukemia. Drugs used in chemotherapy,~     such as cytarabine, work in different ways to stop the growth of cancer cells, either by~     killing the cells or stopping them from dividing. SCH 900776 may stop the growth of cancer~     cells by blocking some of the enzymes needed for cell growth. It is not yet known whether~     cytarabine is more effective with or without SCH 900776 in treating acute myeloid leukemia.~   "
129632|NCT01870583|"~     In women that undergo non-emergency cesarean delivery, we are comparing the skin preparation~     solutions for best outcome of surgical site infection. The three different solutions are:~     Group 1: Iodine povidone based skin preparation solution. Group 2: Chlorhexidine based skin~     preparation solution or Group 3: Combination usage of iodine povidone and chlorhexidine based~     skin preparation solutions. Women are prospectively randomized to one of the three groups and~     followed until thier postpartum visit at 6-8 weeks following delivery.~   "
129633|NCT01870570|"~     The purpose of this study is to determine and compare the glycaemic index values and response~     parameters of 6 food products between 3 laboratories.~   "
129634|NCT01870557|"~     Objective To collate the bone status in type 1 and type 2 diabetics using biochemical markers~     and bone scans.~      Methods:~      This is a multicenter trial involving the University Hospitals of three major danish cities:~     Aalborg, Aarhus and Odense. The trial is of cross-sectional design and consists of~     examinations including:~        -  Blood samples to analyze bone markers, glycemic state, kidney function and sex-hormones.~        -  24 hour urine sample to analyze bone markers and kidney function.~        -  Bone scans including dual energy x-ray absorptiometry (DXA) and high resolution~          peripheral quantitative computed tomography (HRpQCT) to evaluate Bone Mineral Density,~          t-score and bone structure.~      Participants:~      100 type 1 diabetics and 100 type 2 diabetics recruited from outpatient clinics at Aalborg,~     Aarhus and Odense, general practitioners and flyers.~   "
129635|NCT01870544|"~     The purpose of the weight-loss study is to characterize the effect of LGG supplementation on~     the relative abundance of phyla in the gut microbiota of patients undergoing gastric bypass~     and sleeve gastrectomy surgery, and to elucidate a relationship between the gut microbiota~     pattern and the degree of weight-loss post-surgery.~      The investigators hypothesize that LGG administration will result in a leaner pattern of~     gut microbiota that will lead to higher weight loss at 3 months post-surgery.~   "
129636|NCT01870531|"~     This study is to determine the clinical and neuroimaging characteristics of Transient~     Ischemic Attacks in Korean populations.~   "
129637|NCT01870518|"~     Purpose: This is a prospective single-center, randomized, patient and evaluator-blind~     clinical trial to compare the neurocognitive outcomes of globus pallidus interna (GPi) versus~     subthalamic nucleus (STN) deep brain stimulation (DBS) in Parkinson's disease (PD) patients~     with mild cognitive impairment (MCI).~   "
129638|NCT01870505|"~     The purpose of this study is to test the safety of a drug called BYL719 at different dose~     levels. The investigators want to find out what effects, good and/or bad, BYL719 has on the~     patient and breast cancer. BYL719 will be given with either letrozole or exemestane to~     patients with HR+ locally-advanced or metastatic breast cancer. When the recommended phase II~     dose of BYL719 in combination with letrozole or exemestane has been determined in the~     dose-finding phase, an additional 10 patients will be enrolled onto each arm in an expansion~     phase of the study. The purpose of the expansion phase is to further define the safety and~     feasibility of BYL719 in combination with letrozole or exemestane at the recommended phase II~     dose, and to estimate efficacy.~   "
129724|NCT01869387|"~     There is evidence that noninvasive mechanical ventilation (NIV) is effective in the treatment~     of severe exacerbations of COPD presenting respiratory acidosis.~      The aim of the study is to evaluate the benefit of adding NIV to conventional treatment in~     patients with COPD exacerbation and hypercapnic respiratory failure without acidosis~     requiring hospital admission. It is known that NIV improves respiratory mechanics, so the~     primary outcome will be respiratory muscle function.~      All patients admitted to the hospital for COPD exacerbation and hypercapnic respiratory~     failure without acidosis will be included for a period of 12 months. The patients will be~     randomized into two groups (conventional treatment or conventional treatment plus NIV).~     Clinical data, blood gases, muscle strength parameters will be collected at the inclusion~     time and 24h after starting NIV. Quality of life and hospital stay will be measured at~     discharge. All patients will be followed for a year.~   "
129639|NCT01870492|"~     Limited access is a major hurdle in the treatment of AIS; many hospitals, especially rural~     hospitals, do not have the infrastructure or medical support to effectively treat AIS~     patients.5 Failure to recognize the signs and symptoms of stroke by the patient and/or~     emergency medical services (EMS) is another barrier to the timely treatment of AIS. Several~     studies, including the Paul Coverdell National Acute Stroke Registry (PCNASR), have reported~     low rates of adherence to stroke care guidelines, suggesting that many AIS patients do not~     receive proper treatment according to established guidelines. Thus, there remains an~     increasing need to assess and address the barriers that prevent patient access to proper AIS~     treatment.~      Annually, approximately 20,000 patients are discharged from Wisconsin hospitals with the~     diagnosis of stroke and an estimated 4,000 patients die from stroke each year in WI. To date,~     there have been no statewide studies initiated in Wisconsin to assess the regional barriers~     to the treatment of AIS patients with thrombolytic or endovascular therapy, and many~     hospitals do not routinely collect and analyze AIS patient data.~      The goal of the Improving Patient Access to Stroke Therapy (IMPACT) pilot study is to engage~     community hospitals statewide to identify the regional barriers to AIS therapy in WI.~   "
129640|NCT01870479|"~     Main purpose: To determine if live music moderates the level of chemotherapy related anxiety,~     in patients with haematological cancer~      The investigators hypothesize that live music:~        1. Have an ameliorating effect on physical and psychological symptoms during chemotherapy~          treatment~        2. May counteract the patients feeling of loss of identity and alienation in this~          particular group of cancer patients.~        3. Is more effective in patients with good musical abilities.~        4. Is more effective than taped music.~      Method: Intervention groups:~        1. Listening to patient-preferred live music during chemotherapy~        2. Listening to patient-preferred taped music during chemotherapy~        3. Standard care~      Endpoints:~      Primary: Level of anxiety measured by STAI. Secondary: Serum catecholamines.~      Background: In order to establish the intervention procedures, the investigators have carried~     out a pilot study at the hematology department at Hospital of Southwest Denmark, including~     students from the Academy of Music and Dramatic Arts, Southern Denmark. The pilot results~     indicates that live music has an uplifting, pain relieving, and then releasing effect and~     that music has a positive impact on hospitalisation. According to the evaluation forms filled~     out by 243 cancer patients, the music experience has provided human anchorage/cohesion as a~     counterweight to disease fixation and alienation Chemotherapy involves major physical and~     psychological problems. Not much has been provided in the clinical setting which relieves the~     symptoms of anxiety associated with chemotherapy. A review of the literature illustrate the~     need for developing new potential areas of intervention that takes into account, that not~     only do cancer patients face challenges in everyday life ranging from physiological changes~     over social to psychological problems, but also during treatment procedures, which may cause~     a higher level of anxiety associated with these procedures, e.g., chemotherapy infusion.This~     project investigates to what degree live music may relieve some of these symptoms during~     treatment for haematological cancer. The project is created in order to both measure~     psychosocial effects as well as direct stress measures, i.e. serum catecholamine. These~     physiological changes are measured in order to shed light on the mechanism behind the~     potential effects of live music on discomfort in connection with chemotherapy treatment.~      Perspectives: The vision of the project focus on strengthening the cancer patients' ability~     to cope with physiological and psychological issues during chemotherapy sessions and to make~     the patients conscious of music as an option in these coping efforts. Hopefully, the results~     will provide a scientific basis for an evaluation of the perspectives and the potentials of~     live music treatment during chemotherapy infusion among cancer patients.~   "
129641|NCT01870466|"~     The purpose of this study is to evaluate pharmacodynamic drug interaction between cilostazol~     and statins (simvastatin as a CYP3A substrate and rosuvastatin as a non-CYP3A substrate) in~     healthy male subjects.~   "
129642|NCT01870453|"~     The objective of the study is to determine the effects of different anesthetic agents on~     cognitive function in patients with Alzheimer's disease (AD). The investigators will test the~     hypothesis that anesthesia with desflurane or propofol, compared to isoflurane or~     sevoflurane, will have less of an effect on post-operative cognitive dysfunction in patients~     with AD.~   "
129643|NCT01870440|"~     The purpose of this study is to determine whether an intravitreal dexamethasone implant~     (Ozurdex, Allergan) is effective to manage macular edema secondary to non-infectious uveitis.~   "
129644|NCT01870427|"~     The purpose of the study is to determine the effect of Intravitreal Aflibercept Injection~     (IAI) on previously treated Central Retinal Vein Occlusions (CRVOs) with other Anti-VEGF~     agents.~   "
129645|NCT01870414|"~     The influence of cryotherapy on ankle motor control and balance of athletes is controversial.~     The aim of this study is to assess the neuromuscular response of the dominant leg and body~     balance basketball athletes after application of cryotherapy. The sample is distributed into~     two groups. Group one will consist of 20 basketball players without a history of ankle~     sprains in the past 12 months and no complaints of instability in this joint, and group two,~     20 non-athletes, active, no complaints in the lower limb in the last 12 months. Will perform~     the inversion movements and single-leg hop for the analysis of the electromyographic signal~     of anterior tibial, peroneal, gastrocnemius (lateral), rectus femoris, hamstrings and gluteus~     medius. Will also be performed kinematic analysis in search of body balance and range of~     motion of the joints of the lower limbs. And yet, the analysis of the plantar support and~     ground reaction force. After the initial collection of the data subjects will be submitted to~     the application of cryotherapy by immersion in a time of 20 minutes, with a temperature of 6~     ± 2 degrees Celsius. Data collection will be held in pre, 0, 10, 20 and 30 minutes after~     application of cryotherapy. The data will be statistically analyzed to compare the results in~     collection times within and between groups. The significance level is set at 5%. The data~     support the intended use of cryotherapy in motor control of the inversion movement, jump and~     balance of athletes.~   "
129646|NCT01870401|"~     To assess the safety and efficacy of the Lutonix Drug Coated Balloon (DCB) for treatment of~     stenosis or occlusion of native below-the-knee arteries.~   "
129647|NCT01870388|"~     The main purpose of this study is to measure how much of the study drug called baricitinib~     gets into the blood stream and how long it takes the body to get rid of it. Healthy~     participants and those with liver disease may enroll. The study will last about 7 days for~     each participant, not including screening.~   "
129648|NCT01870375|"~     Neurobehavioral function and quality of life are compromised in many patients with~     mucopolysaccharidosis (MPS) disorders. The long-term goals of this research are to: 1) more~     accurately inform patients/parents regarding potential neurobehavioral outcomes; 2) develop~     sensitive measures of disease progression and central nervous system (CNS) treatment outcome;~     and 3) help clinical researchers develop direct treatments for specific brain~     structures/functions. The investigators hypothesize that specific and localized neuroimaging~     and neuropsychological findings and their relationship will be distinct for each MPS~     disorder. It is further hypothesized that without treatment, functions will decline and~     structure will change over time in a predictable fashion, and will be related to locus of~     abnormality and stage of disease.~   "
130119|NCT01864213|"~     Ametop is a numbing cream used to ease the pain of having blood drawn or an IV inserted. It~     is safe and virtually none enters the blood stream. It's effectiveness at reducing the pain~     of the freezing injection prior to epidural/ spinal anesthesia in pregnant women has not been~     studied.~   "
129649|NCT01870362|"~     Periodontal disease is a major cause of tooth loss in humans and is one of the most prevalent~     diseases associated with bone loss. Following bacterial colonization, the gingiva becomes~     inflamed leading, in some cases, to the destruction of the alveolar bone. Periodontitis has~     two distinct but interconnected etiologic components, periodontopathic bacteria and~     host-mediated connective tissue-destructive responses to the causative bacteria and their~     metabolic products.~      A few studies have revealed that probiotic Lactobacillus strains were useful in reducing~     gingival inflammation and the number of black-pigmented rods, including Porphyromonas~     gingivalis (Pg), in the saliva and sub-gingival plaque. Concerning periodontal conditions,~     its shown that application of beneficial bacteria, as an adjunct to scaling and root planing~     (SRP), can inhibit re-colonization of pathogens in periodontal pockets and reduce bleeding on~     probing.~      The aim of the present study is to evaluate the improvement of periodontal health with~     probiotic (Inersan) lozenges, used as an adjunct to scaling and root planing [SRP].~   "
129650|NCT01870349|"~     The purpose of this study is to determine whether there are differences in inflammatory~     markers and bone-mediator protein expression in the fluid surrounding implant abutments~     manufactured with either titanium or zirconium.~   "
129651|NCT01870336|"~     The purpose of this study is to evaluate the immediate and short-term effects of the~     combination of lateral customized foot orthoses on the pain and medial knee loading during~     gait among medial knee osteoarthritis patients. The effects of the combination is compared to~     the single use of these devices. The investigators recruited 22 knee osteoarthritis. They~     have to wear each of treatments (foot orthoses, knee brace and combination) during three~     months. A fifteen days wash-out period is given after each three months. Biomechanical~     evaluation is carried out before and after each three months. This evaluation consisted of~     three questionnaires (Knee Osteoarthritis Outcome Score (KOOS), Western Ontario and McMaster~     Universities Osteoarthritis Index ( WOMAC) and Medical Outcome Study Short Form-36(~     MOS-SF36)), a motion analysis with an optoelectronic system, then a 6-min walk test. During~     motion analysis, ten gait trials are executed without treatment and ten with the treatment.~   "
129652|NCT01870323|"~     In an effort to address the physical inactivity crisis among adolescents, the present study~     will examine the efficacy of using an already established Web-based social networking~     platform (i.e., Facebook) to deliver a physical activity intervention to adolescents.~   "
129653|NCT01870310|"~     It is a randomized prospective controlled study evaluating the effect of transcatheter renal~     denervation on the clinical status of patients with chronic heart failure and its safety~     procedures. The working hypothesis of the study is that by performing transcatheter renal~     denervation in patients with chronic heart failure and severe left ventricular systolic~     dysfunction there will a resultant reduction in the renal sympathetic activation which in~     turn will reduce the number of hospitalizations and deaths from heart failure.~   "
129654|NCT01870297|"~     The main purpose of this study is to assess the safety and tolerability of LY3025876 given~     alone (Part A) and in combination with liraglutide (Part B) in participants with type 2~     diabetes mellitus (T2DM).~   "
129655|NCT01870284|"~     This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to placebo~     in participants with active AS.~   "
129656|NCT01870271|"~     The aim of this pilot study is to evaluate the developmentally adapted cognitive processing~     therapy (D-CPT)in adolescents suffering from childhood abuse(CA)or physical abuse (PA)~     related PTSD. D-CPT's feasibility and efficacy will be examined in 20 adolescents suffering~     from CA or PA-related PTSD in a multicenter study (3 sites).Patients will be assessed prior~     to (t0), post (t1) and 6 weeks after treatment (t2). Assessments include Clinician~     Administered PTSD Scale (CAPS), UCLA PTSD Index (UCLA), Beck Depression Inventory (BDI),~     Adolescent Dissociative Experiences Scale (A-DES), and Borderline Symptom List (BSL-23).~   "
129657|NCT01870258|"~     prediction of MI in patients with chest pain and nondiagnostic ECG was done in 2 weeks~   "
129658|NCT01870245|"~     This is a randomized, double-blind, placebo-controlled, multiple-dose study, designed to~     assess the safety, tolerability, and pharmacokinetics (PK) of ACHN-975. This study will take~     place in the US at one clinical site.~   "
129659|NCT01870232|"~     Dental anesthesia is routinely performed based on anatomical landmarks which can be variable~     leading to repeated injections and failure. Ultrasonography can be used to guide these~     injections by identifying the nerves, accompanying blood vessels and the bony landmarks. 20~     healthy adult patients will be selected to receive ultrasound guided greater palatine nerve~     block (gpn) (10 patients) or inferior alveolar nerve (ian) block (10 patients) depending on~     the dental procedure they are undergoing. The study will evaluate the feasibility and success~     rates of the ultrasound guided gpn and ian nerve block.~   "
129660|NCT01870219|"~     The aim of this study was to evaluate the effect of sevoflurane or ketamine on the QTc and~     Tp-e interval during in patients with major depression.~   "
129661|NCT01870206|"~     Polio is a highly infectious disease caused by a virus. It invades the nervous system, and~     can cause total paralysis in a matter of hours. The virus enters the body through the mouth~     and multiplies in the intestine. Initial symptoms are fever, fatigue, headache, vomiting,~     stiffness in the neck and pain in the limbs. One in 200 infections leads to irreversible~     paralysis (usually in the legs). Among those paralysed, 5% to 10% die when their breathing~     muscles become immobilized. There is no cure for polio, it can only be prevented. Polio~     vaccine, given multiple times, can protect a child for life.~      Compare in newborns the immunogenicity and safety of the vaccine OPV produced by Birmex~     compared with the vaccine OPV produced by Sanofi Pasteur, both produced in Vero cells.~   "
129725|NCT01869374|"~     To evaluate the feasibility, tolerability and efficacy of Magnetic Seizure Therapy (MST) in~     elderly patients with a major depressive episode, who are randomly assigned to receive an~     acute course of MST or ECT.~      The investigators hypothesize:~        1. MST and ECT will have similar antidepressant efficacy~        2. MST will have less post-treatment amnesia than ECT as reflected in a primary measures of~          anterograde and retrograde amnesia following the acute treatment phase.~        3. At follow up, MST will show a lesser degree of persisting deficit in measures of~          retrograde amnesia than ECT.~   "
130149|NCT01863823|"~     1. Gastric eradication has no effective on oral H. pylori infection.~        2. Treatment of oral infection increase success rate of eradication on stomach infection.~   "
129662|NCT01870193|"~     Glutathione is an important antioxidant protein which protects cells from harmful oxidative~     stress. Elderly humans are known to have elevated oxidative stress and deficiency of~     glutathione, but it is not known whether there is deficient synthesis of glutathione in~     muscle tissue of elderly humans.~      Mitochondria are engines of cells where food consumed is burned to make energy. Under normal~     conditions the fuel of choice in the fasted state is fat, but fasted elderly humans are not~     able to oxidize fat as well as healthy young humans. Elderly humans also have the highest~     incidence and prevalence of being overweight and obese, and have increased storage of fat in~     liver and muscle.~      This study will help determine whether~        1. elderly humans have diminished synthesis of glutathione in the skeletal muscle, and~          whether this can be improved by supplementing cysteine and glycine (and not an~          isonitrogenous placebo) in the diet;~        2. improving muscle glutathione concentrations can also improve fuel oxidation in aging;~        3. improvement of intracellular glutathione concentrations will be associated with a change~          in total body fat content~   "
129663|NCT01870180|"~     Meibomian gland dysfunction (MGD) is a common condition that causes the secretion from~     meibomian glands in the eyelids to become blocked. Normally, the secretion helps to maintain~     a healthy tear film. In MGD, the tear film becomes unstable and often causes dry eye~     symptoms. Treatments often involve gently warming the eyelids to melt this blockage which~     prevents tears from spreading over the eye. Although there has been some research on~     application of heat with warm moist flannels, the Eye Bags potentially offers a simpler and~     more effective method of applying heat to the eyelids. This study will test the efficiency of~     these eyelid warming devices over a period of two weeks use in one eye compared to the other~     non-treated eye.~   "
129664|NCT01870167|"~     The aim of this study is to evaluate if a single i.v. dose of co-amoxiclav before PEG can~     reduce the incidence of peristomal wound infection in the paediatric population.~   "
129665|NCT01870154|"~     Background: Burnout syndrome is an important health problem that affects many professionals~     and must be addressed globally, with both organizational measures and personal interventions.~     Burnout of health professionals can be prevented in order to avoid personal, familial, and~     social consequences, as well as repercussions for patients.~      Methods/Design: This work describes a protocol for a controlled, pragmatic, randomized~     clinical trial in 2 parallel groups: intervention and control. All health professionals from~     7 health care centers (HCCs) will form the intervention group, and all health professionals~     from 7 different HCCs will form the control group. The intervention group will receive 16~     hours of training at their work place. The Maslach's burnout inventory (MBI), burnout~     physician Questionnaire (CDPM) or burnout nurse Questionnaire (CDPE), and the 28-item~     Goldberg's General Health Questionnaire (GHQ-28), validated for our setting, will be used as~     measurement tools. Change in the average scores from the MBI emotional exhaustion scale will~     be compared between the intervention and control groups, measured as intention-to-treat, and~     the intervention will be considered effective if a minimum increase of 20% is achieved.~      Discussion: Due to the deleterious consequences of burnout syndrome for people suffering from~     it and for the organization where they work, it is necessary to evaluate the effectiveness of~     certain interventions for its prevention. Organizational measures are important for~     preventing burnout syndrome, but so is providing professionals with coping strategies, as~     this group intervention intends to do.~   "
129666|NCT01870141|"~     Increasing evidence suggests that psychological disorders play an important role in the~     development and worsening of type 2 diabetes (T2D). Among the spectrum of psychological~     disorders, there is a wide literature about the association between depression and T2D and~     current data show an approximately two-fold prevalence of depression in adults affected by~     diabetes compared to un-affected subjects. Moreover, depression in diabetic patients is~     associated with higher blood glucose levels, poorer adherence to therapeutic regimens~     (whether pharmacological or therapeutic lifestyle changes), more medical complications, and~     higher hospitalization rates. Nevertheless, at the best of our knowledge, the mechanism~     underlying the association between depression and adverse diabetes-related outcomes is~     currently unresolved.~      Aim of this project is to assess the efficacy of a psychological treatment for diabetic~     patients with suboptimal level of Hemoglobin A1c. This project is a RCT that seeks to address~     the question if type 2 diabetic patients with suboptimal glycaemic control would benefit from~     a specific psychological intervention, as specified below. A total of 80 diabetic patients~     will be recruited and randomly assigned to two treatment arms:~        1. Standard diabetes care~        2. 24 individual sessions of psychological intervention The expected main outcome is the~          improvement of glycaemic control under psychological intervention in 38 weeks of follow~          up.~      Secondary outcomes: reduction of depression and anxiety, improvement in self-efficacy,~     perceived interference caused by diabetes, family support and eating problems.~   "
129667|NCT01870128|"~     Many studies have been conducted to evaluate the role of pulse steroids in early rheumatoid~     arthritis (RA) but no consensus exists. The aim of this study is to study the efficacy of~     various treatment regimens in early RA. Methods: This is a randomized open-labeled trial.~     Patients were randomised into three groups. In group A, patients were treated with single~     drug (methotrexate 15 mg/wk). The patients in Group B were treated with a combination of~     DMARDS (Methotrexate, sulfasalazine and hydroxychloroquine). The patients in Group C received~     combination therapy as in group B and 3 pulses of methylprednisolone intravenously.~   "
129668|NCT01870115|"~     The investigators' long-term goal is to employ novel methods to improve bone formation and~     bone density in women (and men) with osteopenia or osteoporosis while also decreasing signs~     and symptoms of degenerative joint and disc disease that commonly accompany bone loss as well~     as improve quality of life (QOL). These conditions generally begin silently as early as the~     menopause transition and progress to osteopenia and osteoporosis during the post-menopausal~     years in aging women. The investigators also envision this will be beneficial in aging~     andropausal men with these conditions. The investigators postulate that melatonin in novel~     combination with other natural bone-protective agents may act in a chronosynergy manner to~     prevent and correct these perturbations, reducing the risk of bone fractures, and lessening~     the stiffness and pain associated with bone, joint and cartilage degeneration and improving~     quality of life (QOL). The objective here, which is the investigators' next step in pursuit~     of our goal, is to assess the efficacy of an alternative therapy that uses a novel~     combination of bone-forming agents, melatonin, strontium (citrate)/ vitamin K2 (MK7), and~     vitamin D3 on bone health in a postmenopausal population. Melatonin is a novel alternative to~     current treatment(s) because it has multiple bone-protective and sleep-promoting activities~     within the body, and it is relatively safe so it can be used in an aging population without~     untoward side effects; strontium and vitamin D3 are shown to enhance bone mineralization and~     improve post-menopausal osteoporosis. The project goal is to identify if this combination~     therapy improves bone health and QOL compared to women taking placebo. The investigators'~     central hypothesis is that combination therapy using melatonin, strontium, vitamin K2, and~     vitamin D3 will improve bone health and overall QOL in postmenopausal women not taking this~     regimen by reducing osteoclast activity and increasing osteoblast activity and by improving~     subjective measures of stress, anxiety, depression and menopause-related symptoms.~   "
129670|NCT01870089|"~     Knowledge-based systems were initially developped to automatically adapt pressure support~     settings during invasive ventilation, and proved to be at least as efficient as experienced~     clinicians.~      Non-invasive ventilation has become the standard of care for patients suffering from acute~     hypercapnic respiratory failure (ARF)and has reduced the need for endotracheal intubation in~     these patients, thus reducing their hospital mortality.~      NIV success or failure is closely related to the tolerance of NIV treatment, which is tightly~     correlated to patient-ventilator synchrony. As severe asynchronies frequently occurs during~     NIV (namely in more than 40% of patients) and as the occurence of asynchronies is related to~     the use of high pressure support levels, to the presence of leaks and/or to non optimal~     expiratory trigger settings, very frequent ventilator settings adaptations should allow~     reducing patient-ventilator asynchronies but require the presence of an experienced clinician~     at the bedside during NIV treatment.~      A computer-driven ventilator settings adaptation has the adavantage of permitting very~     frequent ventilator settings adaptation whithout requiring the presence of an experienced~     clinician at the bedside and could possibly improve patient-ventilator interaction.~      The aim of the present study is to test the faisability of using the Smartcare NIV~     computer-driven system to automatically adapt ventilator settings during non invasive~     ventilation delivered because of acute respiratory failure.~   "
129671|NCT01870076|"~     Healing Touch improves measures of sleep the night prior to surgery, thus improving~     surgery-related morbidity.~   "
129672|NCT01870063|"~     Correlation between FIBTEM and intraoperative blood loss~   "
129673|NCT01870050|"~     Principal aim of this study is to assess whether a combination of topical dapsone and~     clobetasol as a topical steroid is superior to clobetasol alone as treatment of prurigo~     nodularis or lichen simplex chronicus in a side to side comparison. The study is primarily~     exploratory and essentially meant to inform the sponsor whether further development of a~     combination treatment formulation is warranted~   "
129674|NCT01870037|"~     The primary objective of this study is to evaluate the safety of a single treatment of~     hMaxi-K compared to placebo (PBS-20% sucrose) administered by direct bladder wall injections.~     Two dose levels (16000 µg and 24000 µg -20 or 30 bladder wall injections, respectively) in~     females with moderate OAB/DO of ≥ six months duration will be evaluated. In each dose level,~     6 participants will receive hMaxi-K and 3 will receive placebo. .~      In addition secondary efficacy parameters will be evaluated (change from baseline compared to~     placebo), including number of micturitions per day, volume of micturitions, incontinence~     episodes, pad weight, uninhibited contractions during cystoscopy, and quality of life~     assessments.~   "
129675|NCT01870024|"~     The main purpose of this study is to know on one hand if lorazepam is more (effective) than~     clonazepam and on the other hand if lorazepam is also effective as the association clonazepam~     + fosphenytoin in out-of-hospital treatment of the generalized convulsive status epilepticus~     in adult patients.~   "
129676|NCT01870011|"~     Renal ischemia/reperfusion (I/R)-induced injury is known to be associated with immediate and~     long-term kidney dysfunction after renal transplantation. Protecting the kidney against I/R~     injury and maintaining renal function during renal transplant surgery is therefore very~     important in order to improve post-operative outcome. This purpose of this study is to~     investigate whether propofol anesthesia done in both kidney donors and recipients during~     deceased brain dead donor kidney transplantation is effective in reducing renal I/R injury~     via its antioxidant and antiinflammatory properties and improve post-transplant outcome~     compared to desflurane anesthesia.~   "
129677|NCT01869998|"~     Implication of left veNtricle vortex flow guided aNticOagulation therapy for preVenting~     Apical Thrombus formation In patients with acute myOcardial infarctioN: Multicenter~     Prospective Randomized Clinical Trial; INNOVATION study~   "
129678|NCT01869985|"~     The purpose of this study is to evaluate pharmacokinetics and safety after oral~     administration of HCP1104 and Eperisone Hydrochloride plus Aceclofenac.~   "
129679|NCT01869972|"~     Phenylketonuria (PKU) is a rare disease where the level of phenylalanine (one of the amino~     acids) in the body is greatly increased. High levels can cause brain damage, especially in~     babies and children. This brain damage can be prevented if a special low phenylalanine diet~     is started soon after birth. A new drug, sapropterin, can also lower phenylalanine levels in~     some patients. PKU therapy is monitored by measuring the blood phenylalanine every week, with~     the goal to keep the level within a target range. Recently, studies have suggested that the~     variation in the blood phenylalanine may be just as important as the absolute blood~     phenylalanine level for brain outcome.~      The investigators will look at the variation in blood phenylalanine level over 24 hours to~     see how much the level changes. The investigators will measure this in patients with typical~     PKU who are compliant with the diet and in patients who are not compliant with the diet. The~     investigators will also measure this in patients with mild PKU who do not usually have as~     high levels of phenylalanine. Finally, the investigators will see if patients on sapropterin~     have lower variation.~   "
129680|NCT01869959|"~     The main purpose of this study was to evaluate the safety and tolerability of LY2405319. It~     was given as a daily injection under the skin to participants with type 2 diabetes mellitus~     (T2DM) for 28 days. This study determined how long the drug stays in the body and how it~     affects blood sugar levels. After screening, the study lasted about 2 months for each~     participant. Participants continued their prestudy regimen of diet and exercise alone or in~     combination with metformin.~   "
129681|NCT01869946|"~     The primary goal is to evaluate ropivacaine blood concentrations during and after local~     anaesthetic (ropivacaine) infiltration - the Caledonian technique - for total hip replacement~     surgery. The investigators plan to measure these levels by testing blood samples taken over a~     timed period.~      This will allow us to confirm whether the current regimen of local anaesthetic use is within~     safe limits.~   "
129734|NCT01869257|"~     Despite adequate antimicrobial prophylaxis and perioperative correction of risk factors,~     surgical site infections (SSI) remain the most frequent complication of colorectal resection~     (range 10-17%). Several strategies may be implemented to prevent SSI. Among these, the use of~     local antimicrobial agents seems successful.~      The primary aim of the present trial was to evaluate the efficacy of a surgical suture,~     coated with Triclosan a synthetic soluble antimicrobial agent, in reducing the SSI rate after~     colorectal operations.~   "
129735|NCT01869244|"~     The aim of the study is to collect comments form users of new type of hand resting splint.~   "
129682|NCT01869933|"~     The present study is intended to evaluate the safety and tolerability of topical OC-10X~     Ophthalmic Suspension in healthy human subjects. OcuCure Therapeutics, Inc. (Roanoke, VA) has~     developed a lead compound, known as OC-10X, which is a selective tubulin inhibitor under~     development for the treatment of Proliferative Diabetic Retinopathy (PDR) and Age-related~     Macular Degeneration (AMD). When administered as a topical eye drop, OC-10X has demonstrated~     both anti-angiogenic (inhibition) and angiolytic (regression) properties in animal models of~     AMD. Unlike other therapies, OC-10X provides the efficacy of a vascular targeting agent~     without the traditional toxicity and works downstream independently of growth factors. As~     demonstrated by OcuCure's preclinical data, tubulin inhibition using OC-10X has promise as a~     new therapeutic approach. PDR is a major cause of blindness in adults and is also caused by~     the growth of abnormal blood vessels. These new blood vessels are fragile and may hemorrhage~     into the vitreous. PDR affects up to 80% of all diabetics who have had diabetes for 15 years~     or more. If administration of OC-10X is well tolerated as a topical eye drop and is well~     tolerated systemically, then OC-10X will have the potential to provide benefits to patients~     with ocular diseases associated with angiogenesis.~   "
129683|NCT01869920|"~     Hypothesis: An educational intervention increases the proportion of mother-infant pairs using~     exclusive breastfeeding~   "
129684|NCT01869907|"~     The purpose of this study is to determine if minocycline is effective in the treatment of~     neuropathic pain. The effect of minocycline will be compared to the effect of placebo and~     amitriptyline.~   "
129685|NCT01869894|"~     Our study is the prospective randomized study for efficacy of uncovered double bare metallic~     stent compared to uncovered single bare metallic stent in malignant biliary obstruction~   "
129686|NCT01869881|"~     Phase 4 Study to evaluate the safety and effect on decreasing subjects' albuminuria who have~     Type 2 Diabetes by using sarpogrelate and placebo.~   "
129687|NCT01869868|"~     The purpose of this study is to determine functional and structural changes in brain~     following treatment of severe depression with electroconvulsive therapy with correlation to~     clinical outcome. Our hypothesis is that there are state-dependent changes in functional~     connectivity within specific neurocircuits systems, as well as structural plasticity changes~     in hippocampus, when recovering from depression.~   "
129688|NCT01869855|"~     The aim of our study is to investigate in randomized controlled fashion whether the~     recurrence and complication rate, after insertion of subperiosteal drainage in the treatment~     of chronic subdural haematoma, is higher compared to insertion of subdural drainage.~      We hypothesize that patients treated with a subperiosteal drainage do not show higher~     recurrence rates than those treated with a subdural drainage, and suffer less complications.~   "
129689|NCT01869842|"~     Optical coherence tomography (OCT) after the stent procedure to improve the adhesion and~     expansion, or incomplete uncovered struts attached to the main track. OCT in clinical areas~     by improving the parameters of the best stent will be useful. However, for better results for~     optical coherence tomography in percutaneous interventions have little useful data on the~     role. Randomized controlled study of the traditional percutaneous coronary intervention and~     intervention using optical coherence tomography.~   "
129690|NCT01869829|"~     The overarching objective is to develop new evidence-based treatment guidelines for invasive~     fungal diseases in children. To accomplish that, this protocol will focus on two specific~     aims: 1) Compare the effectiveness of echinocandin versus amphotericin B or triazole~     antifungal therapy for pediatric invasive candidiasis and for the subset of patients with~     invasive candidemia; 2) Characterize the incidence rate of inpatient pediatric invasive~     candidiasis per hospital admissions.~   "
129691|NCT01869816|"~     Visceral obesity is the one of the major causes of cardiovascular morbidity and mortality in~     industrialized countries. Adipose tissue secretes various kinds of bioactive molecules termed~     adipokines which contribute to the development of obesity-related disorders including~     cardiovascular disease (CVD). Progranulin and CTRP3 are recently discovered novel adipokines.~     Therefore, the investigators tried to compare circulating CTRP-3 and progranulin levels in~     patients with CAD and investigated whether CTRP-3 or progranulin is significantly associated~     with CAD prevalence after adjustment for well-known CAD risk factors.~   "
129692|NCT01869803|"~     This clinical trial studies gemtuzumab ozogamicin in treating patients with relapsed or~     refractory acute myeloid leukemia or acute promyelocytic leukemia. Monoclonal antibodies,~     such as gemtuzumab ozogamicin, can block cancer growth in different ways. Some block the~     ability of cancer to grow and spread. Others find cancer cells and help kill them or carry~     cancer-killing substances to them.~   "
129693|NCT01869790|"~     The purpose of this study is examine the effect of different fat types on postprandial~     glucose control in patients with type 1 diabetes.~      Subjects will have several admissions and, in random order, will receive lunches with~     identical carbohydrate content but different fat content: lunch A will minimal fat content,~     lunch B will contain added butter, lunch C will contain added olive oil, and lunch D will~     contain added cheese. Total fat content in lunches B-D will be the same. Subjects will~     receive identical insulin doses (calculated using the subject's usual insulin-to-carbohydrate~     ratio) for the meals.~      The investigators hypothesize that, despite identical carbohydrate content,the lunches higher~     in saturated fat will lead to more postprandial hyperglycemia than the lunch containing~     minimal fat and the lunch high in monounsaturated fat.~      The hypothesis is that from time points 0-180 minute area under the curve for Lunches A, B,~     C, and D will be the same, whereas from time points 180-360 minutes for Lunch B and D will be~     greater than that of Lunch A and C.~   "
129694|NCT01869777|"~     This clinical trial studies bioelectrical impedance measurement for predicting treatment~     outcome in patients with newly diagnosed acute leukemia. Diagnostic procedures, such as~     bioelectrical impedance measurement, may help predict a patient's response to treatment for~     acute leukemia.~   "
129695|NCT01869764|"~     This phase II clinical trial studies how well omega-3 fatty acid works in treating patients~     with stage I-III breast cancer. Studying samples of tissue and blood in the laboratory from~     breast cancer patients receiving omega-3 fatty acid may help doctors learn more about the~     effects of omega-3 fatty acid on tumor cells.~   "
129736|NCT01869231|"~     Aim was to investigate efficacy of current treatments - water, chewing gum, and olive oil, in~     resolving postoperative ileus.~   "
129696|NCT01869751|"~     Chronic kidney disease is associated with the accumulation of various metabolites, i.e.,~     uremic retention solutes. Evidence is mounting that the colonic microbiome contributes~     substantially to these uremic retention solutes. Indoxyl sulfate and p-cresyl sulfate are~     among the most extensively studied gut microbial metabolites, and are associated with~     cardiovascular disease, chronic kidney disease progression and overall mortality. Colonic~     transit time is an important determinant of intestinal generation and uptake of bacterial~     metabolites. However, it is unknown if accelerating the colonic transit time reduces the~     intestinal generation and uptake of indoxyl sulfate and p-cresyl sulfate. Prucalopride is a~     selective, high-affinity 5-HT4 receptor agonist with a stimulating effect on colonic motility~     and transit. It is currently used in treating chronic slow-transit constipation. An~     observational study will be initiated in non-chronic kidney disease patients with chronic~     slow-transit constipation necessitating treatment with prucalopride to observe its effect on~     serum concentrations and intestinal generation of indoxyl sulfate and p-cresyl sulfate.~   "
129697|NCT01869738|"~     To evaluate the safety and efficacy of the MGuard™ Prime stent in the treatment of blocked~     arteries in coronary arteries in patients undergoing a stenting procedure due to having a~     heart attack. The MGuard Prime stent wil be compared to other FDA approved bare-metal (BMS)~     or drug-eluting (DES) coronary stents. The hypotheses are that (1) the MGuard Prime stent~     will achieve a higher rate of complete ST-segment resolution as seen on the post-procedure~     ECG as compared to the comparator stent, and will have a similar effect on the rate of~     all-cause death or recurrent target vessel myocardial infarction at 365 days post-procedure.~   "
129698|NCT01869725|"~     This clinical trial studies gallium Ga 68-edotreotide positron emission tomography~     (PET)/computed tomography (CT) compared with indium In 111 pentetreotide plus~     contrast-enhanced CT (or MRI) in diagnosing patients with neuroendocrine tumors and other~     somatostatin receptor positive tumors. Diagnostic procedures, such as gallium Ga~     68-edotreotide PET/CT, may help find and diagnose somatostatin receptor positive~     neuroendocrine tumors. It is not yet known whether Ga 68-edotreotide PET/CT is as effective~     as indium In 111 pentetreotide plus contrast-enhanced CT (or MRI) in diagnosis and staging of~     patients with neuroendocrine tumors.~   "
129699|NCT01869712|"~     To assess the application of partially randomized patient preference (PRPP) trial model which~     concerns the patients' preference on evaluation the therapeutic effect of non-pharmaceutical~     therapy, and to observe the therapeutic effect of two kinds of non-pharmaceutical therapies~     (acupuncture and cupping therapy) for fibromyalgia.~   "
129700|NCT01869699|"~     The purpose of this study is to compare the effects of intravenous acetaminophen to placebo~     on body temperature and hemodynamic (heart rate and blood pressure) responses in febrile~     critically ill adult patients.~      There are limited data to explain the variable and unpredictable antipyretic and hemodynamic~     response to acetaminophen in febrile ICU patients. The complex pathophysiology of critically~     ill patients, co-morbid conditions, the effect of multiple pharmacologic and~     non-pharmacologic care interventions, and/or the potential interferences with absorption of~     enteral or rectal formulations may be related to variations in the antipyretic response to~     acetaminophen. It is necessary for clinicians to have a better understanding of the therapy~     response and potential adverse effects of this commonly administered medication, especially~     the recently available IV formulation, in critically ill patients. Further research of the~     antipyretic response to acetaminophen in critically ill patients is warranted to inform~     evidence-based practice guidelines for fever management. Further randomized,~     placebo-controlled studies of hemodynamic responses to IV acetaminophen are also warranted.~      Primary Hypothesis:~      There is a significant reduction in time-weighted average core body temperature over 4 hours~     after administration of IV acetaminophen compared to placebo in febrile critically ill~     patients.~      Secondary Hypotheses:~        1. There is a significant reduction in time-weighted average heart rate over 4 hours after~          administration of IV acetaminophen compared to placebo in febrile critically ill~          patients.~        2. There is a significant reduction in time-weighted mean arterial pressure over 4 hours~          after administration of IV acetaminophen compared to placebo in febrile critically ill~          patients.~      Adult patients with fever (≥ 38.3ºCentigrade/101ºFarenheit) in the intensive care unit will~     be screened for eligibility and enrolled after informed consent. Patients will be randomized~     to receive IV acetaminophen 1 gram or normal saline 100 mLs. Body temperature, heart rate,~     and blood pressure will be measured at baseline and during the 4 hours post study drug~     administration.~   "
129701|NCT01869686|"~     This is a phase 1b, open-label, single dose study in healthy male subjects. Approximately 12~     healthy male subjects will receive a subcutaneous injection of denosumab on Day 1. Subjects~     will be followed by a 105 day treatment-free follow-up period.~   "
129702|NCT01869673|"~     Difficult mask ventilation is usually studied in relation to airway management and difficult~     intubation and mostly during the induction period of anesthesia.~      According to the closed claim reports tracheal extubation and recovery of anesthesia is~     associated with brain damage or death.~      Difficult mask ventilation can also be a problem during the emergence phase of anesthesia~     after extubation. Especially after nasal surgery the use of nasal tampon and casts can~     resemble upper airway obstruction and facial deformity and cause difficult mask ventilation.~      The effectiveness of ventilation is affected by the design of the mask. Leaks may develop due~     to the inability to obtain a tight seal.~      The use of an oral mask for ventilation in patients with nasal tumors and after rhinoplasty~     for patients with a nasal cast has been reported. This suggests that oral mask ventilation,~     rather than face mask ventilation, should be considered after nasal surgery.~      The aim of this prospective randomized study is to compare the face mask and oral mask~     ventilation after nasal surgery in terms of the mask ventilation classification, airway~     pressure, minute ventilation and tidal volume.~      Our hypothesis is that ventilation with oral mask would provide better airway pressures,~     superior mask-ventilation classification and higher tidal volumes compared to face mask~     ventilation in patients with obstructed nasal pasage (nasal packing and/or cast) after nasal~     surgery'.~   "
129703|NCT01869660|"~     To determine whether shared decision making (SDM) intervention improves patient satisfaction~     in patients with first-admission schizophrenia compared with usual care.~   "
129704|NCT01869647|"~     This is the third phase (feasibility and impact) of a three-phase project designed to derive,~     validate and test the feasibility and impact of implementing clinical decision support to~     safely limit the use of Computerized Tomography (CT) and its accompanying radiation and cost~     in emergency department patients with suspected renal colic.~      Hypothesis: Using a before and after model, integration of a clinical prediction rule into~     decisions about imaging in patients with suspected renal colic will result in a reduction of~     between 25-50% of radiation received from CT scanning in this population, without adverse~     affects on patient-centered outcomes.~   "
129705|NCT01869634|"~     Potent HIV suppression with Darunavir-based antiretroviral therapy (ART) will lead to~     repopulation of gastrointestinal-associated lymphoid tissue (GALT) cluster of differentiation~     (CD)4+ T-cell populations, normalization of systemic immune activation, and improved~     HIV-associated cardiovascular disease (CVD) risk.~   "
129706|NCT01869621|"~     The trough concentration of metformin will be examined in monozygotic and dizygotic twins.~     Current twin study will determine the total weight of genetics on the trough concentration of~     metformin.~   "
129707|NCT01869608|"~     Gestational diabetes mellitus (GDM) complicates 5 to 30 % of pregnancies. GDM is defined as~     hyperglycemia with onset or first recognition during pregnancy. Because it is a forerunner of~     type 2 diabetes mellitus (T2DM), professional associations recommend T2DM postpartum~     screening (T2DM-pPS) at 6 weeks/6 months post delivery, using a 75g oral glucose tolerance~     test (OGTT).~      However, less than a quarter of these women are screened. This recommendation has failed for~     multiple reasons; the most important being that busy new mothers must deal with the major~     inconveniences of returning to a sampling center for a 2h testing session, bringing baby~     along or paying for a sitter, transportation, parking… A mother-friendly solution is direly~     needed.~      The investigators hypothesize that, in these women, results of an OGTT performed after~     delivery on the last day of their hospital stay (OGTT-1) will predict results of the~     recommended OGTT (OGTT-2) at 6 weeks/6 months postpartum.~      The main aim of our project is to determine the optimal cut-off value for the 2h glucose~     result during OGTT-1 in order to predict abnormal glucose tolerance status at OGTT-2 (the~     gold standard), in the same woman.~   "
129708|NCT01869595|"~     Objectives~        1. To determine the uptake of universal HIV testing among Thai men who have sex with men~          (MSM) and transgender women (TG)~        2. To determine the uptake of antiretroviral treatment (ART) regardless of CD4 count among~          Thai MSM/TG who test positive for HIV~      Subject population:. Men or transgender women who have sex with men,Thai nationals, age ≥18~     years old, Have engaged in anal intercourse with a man without using a condom at least one~     time in the last 6 months or have had at least 3 male sex partners in the last 6 months,Not~     known to be HIV-positive (either have never been tested for HIV or have had a previous~     negative HIV test)~      Number of participants:2000 Thai MSM and TG with approximately 76%-90% in Bangkok, 5%-12% in~     Lampang and 5-12% in Ubonratchathani.~   "
129709|NCT01869582|"~     Safer Births is a research and development collaboration to establish new knowledge and new~     innovative products to better equip and increase competence of health workers for safer~     births and increased newborn survival worldwide.~      The main objectives are:~      To randomize different devices for fetal heart rate assessments. To assess if a novel Newborn~     Resuscitation Monitor will facilitate newborn resuscitation in a low-resource setting. To~     determine bag mask ventilation treatment and devices beneficial for neonatal outcome.~   "
129710|NCT01869569|"~     Rationale: Pregabalin is effective on radiotherapy-related neuropathic pain. Purpose: This~     randomized, double-blind, placebo-controlled trial aims to investigate the effect and safety~     of pregabalin in treating radiotherapy-related neuropathic pain.~   "
129711|NCT01869556|"~     Patients having Cesarean section after they have been in labor for many hours bleed much~     more, in average twice as much, as compared with patients having an elective Cesarean~     section. The investigators believe a simple change in practice might contribute to reduce~     this bleeding. This study will involve the use of oxytocin (also known as syntocinon),~     ergonovine (also known as ergot) and carboprost (also known as hemabate). Oxytocin is~     routinely used to help contract the uterus and keep it contracted after the delivery of the~     baby and placenta, so as to reduce the amount of blood loss. Ergonovine is also given through~     the intravenous line, while carboprost is given as an injection in the muscle. Although they~     are not routinely given in every case, these are very frequently given as rescue medications~     to patients who fail to respond appropriately to oxytocin. This study is designed to~     determine if ergonovine or carboprost given in association with oxytocin, in a preventive~     way, after delivery of the baby and placenta, can reduce the amount of blood loss during~     Cesarean sections following a trial of labour.~   "
129712|NCT01869543|"~     Two hundred moderate to severely asthmatic children (6-12 years) will be enrolled in a study~     to look at the effectiveness of high efficiency filtration of indoor air in homes on reducing~     asthma symptoms. One intervention group will have high efficiency filters or filtration~     systems installed in their central heating and air conditioning (HVAC) system. The second~     intervention group will have high efficiency portable air cleaners placed in the child's~     bedroom and in the main living area. Each participant will receive true air filtration for a~     year and a placebo for a year. During the placebo period a sham filter will be used that~     removes very little of the particles. Measures of health effects will include days of~     symptoms, unplanned utilization of the healthcare system for asthma-related illness,~     short-term medication use, peak exhaled flow, spirometry, and exhaled nitric oxide (eNO).~   "
129713|NCT01869530|"~     TARGet Kids! (The Applied Research Group for Kids) is a research study enrolling healthy~     children aged 0-5 years. The aim of the TARGet Kids! registry is to link early life exposures~     to health problems including obesity, micronutrient deficiencies, and developmental problems.~      TARGet Kids! represents an innovative collaboration between child health researchers and~     children's primary care doctors (pediatricians and family physicians) to promote research~     that really matters and create solutions to some of the today's biggest health concerns. The~     results of this collaborative research study are not only improving the quality of children's~     healthcare but also the health of children across the country. Coordinated by Sick Kids and~     St. Michael's Hospital with data management services by the Applied Health Research Centre~     (AHRC), TARGet Kids! is the only primary care research network for children in Canada.~   "
129714|NCT01869517|"~     Various approaches, including surgical and non-surgical management have been proposed for~     keratoconus. One of the surgical procedures is Intrastromal Corneal Ring implantations that~     have been designed to achieve refractive readjustment by flattening the cornea. There are~     different models of Intrastromal Corneal rings available: intrastromal corneal ring segments~     (ICRS) such as Keraring and intrastromal corneal continuous ring (ICCR) like Myoring.~      Most studies of these two types of ring implantation outcomes are retrospective case series.~     Thus, this Randomized Clinical Trial study was designed with the aim of Comparing visual and~     refractive outcomes and complications of insertion Myoring versus Keraring using Femtosecond~     laser. Keratoconus patients with compound myopic astigmatism who meet the inclusion criteria~     will randomly allocated to the Keraring and Myoring groups. Subsequently, the clinical~     outcomes of two groups will be compared at one,3 and 6 months after surgery.~   "
129833|NCT01867957|"~     1. BACKGROUND The newly developed anthrax vaccine GC1109 has been proven safe and effective~          in preclinical studies.~        2. OBJECTIVE~           - To evaluate the immunogenicity and safety of the anthrax vaccine GC1109 in healthy~          male volunteers.~        3. STUDY DESIGN~             -  single-blinded~             -  randomized~             -  placebo controlled~             -  phase 1 study~   "
129715|NCT01869504|"~     Drainage of air and fluid from the chest cavity using plastic tubes (chest drains) is an~     essential tool in Chest Medicine. A common complication of drain insertion is accidental~     removal of the drain, usually as a result of inadequate securing techniques, with rates of up~     to 1 in 5 reported. This often results in the need for further procedures (including drain~     re-siting), with associated additional risk to the patient and an increase in health care~     costs. One suggested method to reduce premature drain removal is to use chest drains with~     ballooned tips, much like a bladder catheter. These would provide a physical obstruction~     inside the chest cavity at the insertion site, whilst being easy to use as stitching or~     extensive taping may not be required.~      The investigators propose a trial of a dedicated ballooned chest drain to investigate whether~     a reduction in drain re-siting rates can be achieved. Pain scores will also be assessed~     during this trial to ensure that irritation of the lining of the lung or chest wall by the~     balloon is not excessive.~   "
129716|NCT01869491|"~     This study is being conducted to provide evidence that Compound Sodium Alginate Double Action~     Chewable Tablets are effective in managing the symptoms of heartburn, acid regurgitation and~     dyspepsia in patients with Gastroesophageal Reflux Disease (GERD).~   "
129717|NCT01869478|"~     This pilot trial will be the first step toward direct comparison of delivery of endovascular~     reperfusion therapy to intravenous recombinant tissue plasminogen activator (rt-PA) in a~     time-to-treatment framework shown as most effective by the NINDS rt-PA Stroke Trial. A~     randomized trial is justified for the following reasons: 1) The high rate of death and~     disability associated with ischemic stroke despite treatment with intravenous rt-PA mandates~     critical analysis of alternate therapies with therapeutic potential, 2) endovascular~     treatment for acute ischemic stroke is expanding in North America without compelling evidence~     of safety and efficacy from well-designed clinical trials, 3) critical cost-effectiveness~     analysis cannot be done without acquiring pertinent outcomes data from controlled studies.~   "
129718|NCT01869465|"~     Previous research undertaken among adults in high endemic districts of Busia, Adjumani, Moyo~     and Nebbi reported unwillingness to take preventive treatment. A particular study conducted~     in primary schools of Jinja district showed that only 30% of school children took~     praziquantel during the 2011 Mass Drug Administration (MDA). Fear of side effects of~     praziquantel, lack of knowledge about schistosomiasis transmission and prevention and lack of~     teacher support were some of the major factors associated with the low uptake. Similar~     reasons for non-uptake have been reported elsewhere. Thus, measures are needed to increase~     uptake of Mass Drug Administration (MDA) in Uganda. There is no doubt that health education~     facilitates a better understanding of the obvious risks to health, including the knowledge of~     preventing parasitic infections among primary school children. Better compliance to treatment~     for schistosomiasis among school children can be achieved through implementing carefully~     designed programs involving face to face education methods. Increasing knowledge about~     schistosomiasis transmission and prevention and implementing measures to mitigate the side~     effects attributable to praziquantel, such as providing a snack prior to drug administration~     may improve uptake of the drug among school children.~      Hypothesis- Provision of a pre-treatment snack is effective in improving uptake of preventive~     treatment for intestinal schistosomiasis among primary school children.~   "
129719|NCT01869452|"~     A first therapeutic education is given before patient's discharge at the hospital, then a~     dedicated nurse follows patients through the phone,regularly according to patients' needs,~     continues to give advise on risk factors, information on medication and alert symptoms and~     therapeutic education.~   "
129720|NCT01869439|"~     The purpose of this study is to test wounds found on the outside of the body surface with an~     investigational medical imaging device that collects visual pictures and thermal digital~     pictures of the wound site. The investigational device has not been approved by the Food and~     Drug Administration (FDA).~      The medical imaging device is non-contacting and is non-radiating (delivers no energy to the~     body). It passively collects pictures (typical digital color photographs)and thermal pictures~     (black and white digital photographs of heat at the body surface.)~   "
129721|NCT01869426|"~     Infantile colic is one of the most commonly reported medical problems within the first three~     months of life causing appreciable distress for both parents and pediatricians.~      It appears that multiple independent origins might be involved: amongst them infant's~     difficult temperament, inadequate mother-infant communication or maternal anxiety, transient~     lactase deficiency, exposure to cow's milk, abnormal gastrointestinal function, maternal~     smoking during pregnancy or after delivery. Consequently, various treatment approaches have~     been tried to alleviate this condition.~      Recent studies have suggested that changes of intestinal microflora of a newborn may play an~     important role in pathogenesis of infantile colic. Therefore, dietary supplementation with~     probiotics has been proposed for the improvement of this condition.~   "
129722|NCT01869413|"~     A cystectomy is the removal of the bladder and adjacent organs in patients with bladder~     cancer. This often results in significant blood loss, and about 60% of patients will require~     a blood transfusion during or up to 30 days after surgery. Significant blood loss may result~     in cardiovascular morbidity, and the use of blood products are expensive and expose patients~     to risk.~      Tranexamic acid reduces breakdown of hemostatic blood clots and it has therapeutic benefit~     when used in other surgical procedures to reduce blood loss and the need for transfusion. The~     current study will be the first to evaluate whether tranexamic acid is effective and safe to~     use during radical cystectomy. The results of the study will have an immediate impact on~     patient care.~   "
129723|NCT01869400|"~     Clinical trials are, due to the inclusion and exclusion criteria, accomplished with defined~     patient groups, which are not representative for the whole patient population.~      Especially elderly patients and patients with co-morbidities are underrepresented in clinical~     trials.~      This non-interventional study will examine the efficiency and toxicity of the Yondelis® + PLD~     combination therapy in a general patient population to evaluate if the data collected in the~     clinical trials can be assigned to a general patient population.~   "
129737|NCT01869218|"~     This study is aimed to determine the feasibility of obtaining and molecularly characterizing~     pre-treatment tumor biopsies, to determine the feasibility of obtaining and molecularly~     characterizing archival and post-treatment tumor biopsies, to assess molecular expression~     changes between archival and baseline tumor samples, and to assess molecular expression~     changes between tumor samples obtained at baseline and at the time of disease progression.~   "
129726|NCT01869361|"~     Background: Indomethacin is frequently used as a tocolytic, however there is currently only~     scant evidence to support its efficacy.~      Goals: To delay preterm delivery by 48 hours and to examine longer latency periods and~     maternal and neonatal outcomes Methods: Randomized placebo-controlled trial of indomethacin~     for tocolysis. Women with a singleton pregnancy between 23w0d and 31w6d in preterm labor~     randomly assigned to 50mg indomethacin by mouth followed by 25mg by mouth every 6hour for 48~     hours or placebo. Patients receive betamethasone for fetal lung maturity, if not previously~     administered, and magnesium sulfate for neuroprotection. Ultrasound performed before~     initiation of study drug and after completion of study medication for amniotic fluid index~     and fetal cardiac assessment.~   "
129727|NCT01869348|"~     As individuals age, their physical activity decreases and sedentary time increases. Even~     small changes in these two behaviors can greatly decrease risks for several major health~     problems, including cardiovascular disease, diabetes, and many cancers. Studies that use~     pedometers to encourage walking have successfully increased physical activity, but do not~     address sedentary behaviors such as television watching. The investigators propose to use a~     novel pedometer-like device (Jawbone Up) that encourages both increased physical activity and~     decreased sedentary time. First, the investigators will recruit 10 adults to participate in a~     brief intervention for six weeks. They will wear the wrist-based activity monitor and use a~     mini-tablet device to see feedback on their activity and sedentary time. They will also~     receive brief counseling weekly. The investigators will use this first study to investigate~     the basic feasibility of the intervention materials. Next, the investigators will recruit 20~     adults and randomize them to receive the intervention for 12 weeks or to a waiting list.~     Here, the investigators will test the intervention with refinements made based on participant~     responses from the first small study. Our primary outcomes will be measures of feasibility~     and acceptability across all parts of the study. The investigators hypothesize that the~     intervention will be feasible and acceptable to the participants. The investigators will also~     measure physical activity, sedentary behavior, fitness, body fat, and psychological feelings~     of motivation.~   "
129728|NCT01869335|"~     Radiography of breast specimens is currently the only radiological procedure used to verify~     removal of microcalcifications and presence of tumor-free margins after breast surgical~     resection. Ex vivo MRI will be tested for its ability to detect residual tumor tissue not~     detected by radiography in resected breast tumor specimens and/or its ability to verify~     tumor-free margins in breast cancer detected by MRI only.~   "
129729|NCT01869322|"~     When people break their arm and arrive at Oregon Health and Science University's Emergency~     Department (OHSU ED), they are treated with a short-term means of immobilizing their broken~     arm. The two most common ways of stabilizing the broken parts of the arm are 1) with a~     plaster-based coaptation splint, or 2) with a soft cloth sling and swathe. These hold the arm~     steady until the patient can schedule an appointment with the OHSU Orthopaedic Trauma clinic~     where they will receive definitive evaluation and stabilization/fixation. In much of the~     orthopaedic literature coaptation splints are the default immobilization method. The~     investigators hypothesize however, that sling and swathe immobilization may be equally~     effective for short term stabilization, while being faster to apply, and more comfortable for~     the patient. This randomized, unblinded prospective study will follow the satisfaction,~     quality of life and limited functional outcomes of all enrolled participants during the first~     week following their injury.~   "
129730|NCT01869309|"~     The primary objective is to determine the pharmacodynamic effect of ticagrelor dosing (180mg~     LD/ 90mg BID) at 2, 4 hours and 14 days in stable Coronary artery disease (CAD) patients who~     exhibit high-on prasugrel platelet reactivity defined as Vasodilator Stimulated~     Phosphoprotein-Phosphorylation (VASP-P) >50%.~   "
129731|NCT01869296|"~     The purpose of this study is to compare the cecal intubation rate between two endoscopy water~     pump with different flow rates (1.7 ml/sec vs 10.4 ml/sec) in water immersion colonoscopy~     examination in unsedated patients undergoing diagnostic colonoscopy.~   "
129732|NCT01869283|"~     Neck pain is a prevalent musculoskeletal dysfunction. Studies point that individuals with~     chronic pain have metabolic, vascular and electromyographic changes in trapezius muscle.~     Moreover, a common clinical sign in this muscle in subjects with neck pain is the presence of~     myofascial trigger points. These are related to the sensory, motor and autonomic changes,~     being defined as palpable nodules located in the taut band of skeletal muscle. In this~     context, the focus on treatment modalities stands out in the literature, however, other~     resources commonly used in clinical practice still lack scientific evidence. Therefore, the~     aim of this project is to evaluate the effectiveness of physiotherapy resources in the~     treatment of myofascial trigger points in the trapezius muscle of patients with neck pain.~     For such, volunteers with neck pain for more than 90 days, of both genders, aged between 18~     and 59 years and bilateral myofascial trigger points in the upper trapezius will be~     randomized into the following groups: group 1 (kinesiotherapy, n = 20), group 2~     (kinesiotherapy + static ultrasound, n = 20), group 3 (kinesiotherapy + diadynamic currents,~     n = 20) and group 4 (untreated control, n = 20). Volunteers will undergo ten sessions of~     treatment, being realized the following evaluations: surface electromyography, infrared~     thermography, numerical scale of pain assessment, algometry, Neck Disability Index and skin~     impedance. For data analysis, normality test will used to verify the data distribution and~     consistent statistical test for the appropriate comparisons within and between groups, and~     thus considered two factors in the comparisons, time and group. Will adopt a significance~     level of 5%.~   "
129733|NCT01869270|"~     Hypothesis: To study the natural history of Tay-Sachs disease and evaluate therapeutic~     interventions.~      This study is intended to work in collaboration with NCT00668187 A Natural History Study of~     Hexosaminidase Deficiency. Because so few patients with Tay-Sachs disease present annually,~     we will maximize both research projects by enrolling patients in both studies. For this~     present study, we will perform retrospective medical record review to gather data. Through~     this medical record review, we will collect biomarker analysis results, neuroimaging report~     data, quality-of-life questionnaire data and ophthalmology exam findings. If the subject has~     undergone therapy or treatment, the results will be noted.~   "
129738|NCT01869205|"~     To assess efficacy of bronchoscopic lung volume reduction in Korean emphysema patients~   "
129739|NCT01869192|"~     A primary objective of this study is to evaluate the in vivo response of tumor to~     chemotherapy through gene microarray analysis. Neoadjuvant treatment allows the unique~     opportunity to observe the in vivo effects of cytotoxic therapy on gene expression in tumor~     tissue. The investigators plan to evaluate several different questions by comparing gene~     profiles in different phases of treatment in this study. These are outlined below.~      Hypotheses~        1. Chemotherapy enriches for tumor cell populations that have enhanced resistance and~          survival mechanisms. These mechanisms will in part be identifiable through changes in~          gene expression profiles pre vs. post treatment.~        2. Use of two distinct chemotherapy selection pressures, for example a DNA-damaging regimen~          (epirubicin and cyclophosphamide) or a mitotic spindle/metabolic targeted regimen~          (docetaxel and capecitabine), will allow for the identification of a smaller set of~          genes associated to resistance and survival mechanisms of broad importance.~        3. Genes associated with enrichment for resistance and survival mechanisms will not be~          present in large amounts pretreatment in tumors destined for complete pathologic~          response.~   "
129740|NCT01869179|"~     The investigators will recruit 450 older adults and will utilize 12 Administration on Aging~     (AoA)-supported senior centers to implement a multisite, cluster randomized (by center),~     wait-list clinical trial. Centers will be randomized to receive the choir program immediately~     (intervention group) or after a 6-month delayed intervention phase (control group). The~     community choirs will be led by professional music directors. The investigators will assess~     both primary and secondary outcomes at baseline, 6 and 12 months, with the main intervention~     group comparison being at 6 months. The investigators will also evaluate the start-up and~     ongoing program costs for senior centers, including cost/person served and determine quality~     adjusted life years.~      The hypotheses are:~        1. Compared to delayed intervention controls, participation in a community choir program~          will be associated with improvements/maintenance on the primary outcomes of physical~          function (balance, walking speed, strength), depressive symptoms, and cognition~          (executive function and memory) at 6 months. The investigators also predict within-group~          improvements on these primary outcomes at 12 months.~        2. Compared to delayed intervention controls, participation in a community choir program~          will be associated with improvements in the secondary outcomes of well-being (depressive~          symptoms, loneliness, resilience, social participation, health-related quality of life,~          shortness of breath, functional status, falls, and health services use) at 6 months. The~          investigators also predict within-group improvements on these secondary outcomes at 12~          months.~   "
129741|NCT01869166|"~     RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory~     into patient autologous T cells may make the body build immune response to kill cancer cells.~      PURPOSE: This clinical trial is to study genetically engineered lymphocyte therapy in~     treating patients with EGFR positive advanced/unresectable operation solid tumors, such as~     lung cancer, colorectal cancer，ovary cancer，cholangiocarcinoma，pancreatic cancer，renal~     carcinoma and other relapsed/metastatic tumors.~   "
129742|NCT01869153|"~     Growth is poor in preterm infants, partly due to difficulty identifying when growth is slow.~     The investigators will examine the use of a computer program to try and identify periods of~     growth slowing in preterm babies, and compare those results to the usual assessments made on~     patient care rounds.~   "
129743|NCT01869140|"~     To study the immediate effect of spinal manual therapy on pain perception in normal subjects~   "
129744|NCT01869127|"~     Small association studies have hypothesised that shoes protect against hookworm infection.~     The purpose of this pragmatic study was determine, under field conditions, whether school-age~     children on Pemba Island, Zanzibar, would wear shoes and if shoes protected them against~     hookworm infection.~   "
129745|NCT01869114|"~     This phase II trial studies how well sirolimus and azacitidine works in treating patients~     with high-risk myelodysplastic syndrome or recurrent acute myeloid leukemia. Sirolimus may~     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs~     used in chemotherapy, such as azacitidine, work in different ways to stop the growth of~     cancer cells, either by killing the cells or by stopping them from dividing. Sirolimus and~     azacitidine may kill more cancer cells.~   "
129746|NCT01869101|"~     The purpose of this observational study is to assess the treatment and outcomes of patients~     with prediabetes in community-based clinical practices.~   "
129747|NCT01869088|"~     The purpose of this study is to determine if TACE plus Recombinant Human Adenovirus Type 5~     Injection will improve outcome in patients with advanced hepatocellular carcinoma (HCC) not~     amenable to surgery or local ablative therapy.~   "
129748|NCT01869075|"~     Venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary~     embolism (PE, is one of the common and preventable complications of hospital stay. VTE~     prophylaxis through the use of evidence-based anticoagulant medication options or mechanical~     prophylaxis have been shown to reduce this risk and improve patient safety. Despite an~     abundance of evidence, use of VTE prophylaxis remains low.~      This study assesses the effectiveness of quality improvement strategies (use of pre-printed~     orders, audit and feedback, involvement of the pharmacist as project need and as a reminder~     to the physician, and education of staff) on use of appropriate VTE prophylaxis. The study~     aims to measure if the use of these strategies improves the use of VTE prophylaxis and~     therefore, improves patient safety and patient care by reducing the risk of developing DVT or~     PE.~   "
129749|NCT01869062|"~     The main objective of the SONR-ECHO trial is to demonstrate that optimization of CRT~     parameters by SonR technology is able to increase the rate of CRT-D responders, based on~     significant LV reverse remodeling, as compared to Standard of Care settings.~      This study will also evaluate the effectiveness of CRT-D SonR system as compared to Standard~     of care (SoC) programming methods in providing appropriate LV filling, as expected from the~     Ritter method.~   "
129750|NCT01869049|"~     This project was undertaken by Qilu Hospital of Shandong University and other well-known~     hospitals in China. In order to report the alteration on the macrophage function in the~     spleen tissue of primary immune thrombocytopenia (ITP).~   "
129751|NCT01869036|"~     The aim of this study is to test an efficacy and safety of supplemented by Morphine caudal~     anesthesia in children who undergo renal surgery in our department.~   "
129752|NCT01869023|"~     Malignant pleural mesothelioma (MPM) is a rare disease, but with a very high mortality. MPM~     is frequently found in advanced stages. The standard treatment in advanced pleural~     mesothelioma is cisplatin-based chemotherapy combined with pemetrexed/raltitrexed (phase III~     studies showed its benefit in response and overall survival compared with cisplatin alone).~     There are other active drugs such as liposomal doxorubicin and gemcitabine. Unfortunately,~     cost is an important factor to consider in our population and standard treatments are very~     expensive. Gemcitabine 250 mg infused over 6 hrs in combination with cisplatin, compared to~     the standard administration of gemcitabine 1250 mg infusion of 30 minutes in NSCLC, combined~     with cisplatin showed 75 mg shown in a study to be equally effective in treating cancer~     non-small cell lung. A phase II study using this strategy for advanced MPM has shown~     promising results. Gemcitabine administered in low dose in a six hour infusion may reduce~     cost of treatment without altering the effectiveness.~      Primary Objective.~      -Evaluate the response of treatment with gemcitabine at a dose of 250 mg/m2SC in 6-hour~     infusion combined with cisplatin in patients with unresectable malignant mesothelioma.~      Secondary objectives.~        -  Evaluate toxicity of the combination of gemcitabine at a dose of 250 mg/m2 infused over~          6 hours in with cisplatin in patients with unresectable malignant mesothelioma.~        -  Evaluate the progression free survival (PFS) and overall survival (OS) in patients with~          unresectable MM treated with this combination.~      Hypothesis:~      Combination therapy of gemcitabine at a dose of 250 mg/m2 infusion of 6 hrs applied on day 1~     and 8 combined with cisplatin 35 mg/m2SC applied on day 1 of 3 weeks cycles is a treatment~     that provides similar results in responses when compared with previous studies with the same~     combination therapy, but with a conventional administration (gemcitabine 1,250 mg in 30~     minutes on days 1, 8 and 15).~   "
129753|NCT01869010|"~     The objective of the present study is to analyze the overall tubular function, and in~     particular that from the proximal tubule and the thick ascending loop of Henle (TALH) in~     patients with HIV infection receiving or not tenofovir-containing antiretroviral treatment in~     comparison with seronegative controls, by applying a validated tubular physiological test~     known as Low sodium infusion test.~      Hypothesis is that patients with HIV infection and normal renal function will show~     subclinical tubular abnormalities compared with seronegative controls~   "
129754|NCT01868997|"~     The primary objective of this study is to investigate the efficacy, safety, and tolerability~     of RV 001 (teprotumumab), a fully human anti-IGF1R antibody, administered q3W for 6 months,~     in comparison to placebo, in the treatment of participants suffering from active TED.~      Funding Source - FDA OOPD~   "
129755|NCT01868984|"~     The objective of this study is to evaluate the safety and effectiveness of the use of~     intravascular paclitaxel, in addition to standard therapy, for the treatment of arteriovenous~     dialysis access fistula stenosis.~      A fistulogram will be performed in standard fashion. The diagnostic component will include~     evaluation of the inflow artery, arterial anastomosis and full length of the fistula vein or~     graft, plus venous return up to the heart. The location, vessel size, lesion diameter and~     percent stenosis for each lesion will be recorded. Enrollment and randomization will occur at~     this point.~      All patients will then receive standard therapy for their stenosis. This will include~     intravenous heparin administered in a standard dose of 70 units/kg. Lesions that respond~     poorly to angioplasty (>30% residual stenosis after angioplasty treatment with 2 inflations)~     will be stented. Stent selection will be based on clinical setting. Initial stent treatment~     will utilize an uncovered nitinol stent. Treatment of in-stent restenosis will include~     initial balloon angioplasty, and use of a covered stent (Viabahn, GORE, or Fluency, Bard).~     Documentation of location and type of treatment for each lesion treated will be recorded.~      Once standard treatment is completed, the operating surgeon will be informed of the patient~     randomization: treatment (paclitaxel) or control. For subjects assigned to treatment,~     Paclitaxel solution treatment of each lesion encountered from proximal to distal will be~     attempted until the 20 mg Paclitaxel dose limit is met.~      A TAPAS infusion catheter will be used for all paclitaxel dose administrations. The TAPAS~     infusion catheter will be positioned to reduce the presence of branches which permit the loss~     of paclitaxel from the treatment zone. After the full outflow vein segment is treated, the~     fistulogram is completed in the standard fashion. Prior to removal of the sheath, a final~     angiographic study of all areas treated is performed to document patency and lesion~     appearance.~      For the control group, instead of paclitaxel administration, a sham treatment period of 10~     minutes is allowed to elapse followed by the performance of the final completion angiogram.~     Any additional lesions identified with this study are then treated appropriately following~     standard technique.~      All patients will follow the same follow up evaluation schedule.~   "
129756|NCT01868971|"~     The purpose of this prospective clinical study is to establish the feasibility and usability~     of the ENDORINGS™ when used during standard colonoscopy procedure.~   "
129757|NCT01868958|"~     More than half of the middle-aged population has radiologic evidence of cervical spondylosis~     (Irvine 1965) and a subset of this population develops cervical spondylotic myelopathy (CSM),~     a condition in which the spinal cord is impaired, either by direct mechanical compression or~     indirectly by arterial deprivation and/or venous stasis. In this study we aim to test the~     hypothesis that diffusion tensor imaging can provide prognostic information on the integrity~     of the spine in these patients which is unavailable from conventional MRI images~   "
129758|NCT01868945|"~     The purpose of this study is to assess the dose of Hy.D Calcifediol 25 SD/S (a metabolite of~     vitamin D3) which will achieve the range of mean serum 25(OH)D between 75-100nmol/L in~     physically frail elderly people after 24 weeks of daily supplementation with different doses~     of Hy.D Calcifediol 25 SD/S compared to vitamin D3.~   "
129759|NCT01868932|"~     Hypothesis: substitution of nebulized 3% NaCl (HS) for the standard normal saline (NS) used~     in bronchodilator therapy for acute viral wheezing in all children under age 6 years will~     provide superior symptom relief leading to decreased admission rates from the Emergency~     Department.~      The study will test the efficacy of frequent doses of inhaled bronchodilator co-administered~     with either 3% hypertonic saline (HS, study group) or 0.9% normal saline (NS, control group)~     in a prospective, double blind, randomized controlled, multi-centre clinical trial of~     children under age 6 years presenting to the ED with acute viral-associated wheezing.~   "
129760|NCT01868919|"~     Joint research (quantitative and qualitative methodology) with quasi-experimental design,~     before-after without control group to evaluate the pilot implementation of Positive Parenting~     Program (Triple P) in the context of primary health care in Chile. The hypothesis is that the~     program is feasible and acceptable to the Chilean population.~   "
129761|NCT01868906|"~     The aim of this study is to assess, with 18F-FMISO PET, hypoxia in high grade gliomas and~     changes by spinal cord stimulation in a subset of patients. Additionally, the potential~     correlation with pathological, imaging and clinical parameters will be analyzed.~   "
129762|NCT01868893|"~     This is a multicenter, open-label, single-arm, expanded access treatment study designed to~     provide obinutuzumab to patients with previously untreated Chronic Lymphocytic Leukemia (CLL)~     in combination with chlorambucil and to evaluate the safety and efficacy of obinutuzumab~     administered in combination with chlorambucil. This study will enroll patients with~     previously untreated CD20-positive CLL requiring treatment according to the IWCLL guidelines~     (Hallek et al 2008), as assessed by the investigator.~   "
129775|NCT01868711|"~     Psychological mindedness(PM) is a meta cognitive process in which the person uses his~     cognitive and affective abilities to better understand his thoughts, feelings, and his~     behaviors as they interact with his internal experiences and his external experiences in the~     world, and dynamically modifies his behavior to move towards self actualization, in a manner~     positive to himself and the world. We investigate whether assessment of PM can distinguish~     depressed patients who benefit from CBT.~   "
140637|NCT01726478|"~     The purpose of the study was to determine whether 2.5 international units of oxytocin gives~     adequate uterine tone and is safe as compared to 10 international units of oxytocin following~     caesarean section delivery at Mulago hospital.~   "
129763|NCT01868880|"~     The aim of this prospective, randomized and controlled trial is to evaluate the use of the~     ivabradine in combination to a low-dose of beta-blocker (bisoprolol) versus up-titration of~     beta-blocker (bisoprolol) to obtain heart rate (HR) control with reduction in RV pacing in~     single-chamber or dual chambers ICD recipients HF patients with moderate to severe left~     ventricular dysfunction (FE ≤ 40%) and an heart rate ≥ 70 bpm in sinus rhythm over a~     12-months follow up.~      Besides the investigators want to assess if the combination of ivabradine to a low-dose of~     beta-blocker (bisoprolol) versus up-titration of beta-blocker (bisoprolol) may determine a~     lower degree of left ventricular dysfunction progression, the reduction of ventricular~     arrhythmias burden and ICD appropriate therapy occurrence and the improvement of quality of~     life in ICD heart failure patients.~   "
129764|NCT01868867|"~     The goal of this study is to examine the use of new technologies in disseminating and~     improving CBT treatment for adolescent depression. An on-line therapist training tutorial~     will be followed by 12 weeks of CBT treatment according to the training protocol. CBT~     treatment will be augmented with the use of automated text messages for homework reminders~     and reinforcement of learning. In session patient education and review of CBT concepts will~     be augmented through teaching materials delivered via iPad. 16 therapists will be recruited,~     each treating 4 depressed adolescents. Half the therapists will be randomly assigned to TAU,~     followed by the training intervention. Automated patient outcomes measures will be examined.~   "
129765|NCT01868854|"~     The location of the catheter tip in radiographic planes 1 and 2, is a protection factor for~     the mechanical performance of peritoneal Dialysis. Instead radiographic planes 3 and 4 are~     risk factors.~   "
129766|NCT01868841|"~     The purpose of this study is to demonstrate correlation of the H/M ratio of AdreView when~     derived from a large field of view Anger SPECT system and from a small field of view high~     sensitivity (CZT) SPECT system.~   "
129767|NCT01868828|"~     A multicenter, double arms, prospective randomized controlled phase 4 study. Approximately 50~     previously untreated subjects with multiple myeloma will be enrolled. The study will consist~     of 6 phases, screening, treatment and follow-up.~   "
129768|NCT01868802|"~     A randomized multicentric parallel arms study involving the use of ketamine for~     treatment-resistant depression will be held at three national health provider clinics in the~     Mexican population. The purpose of this study is to determine whether clinical response seen~     in previous studies is replicable in this population.~   "
129769|NCT01868789|"~     The purpose of this study is to compare the average joint motion and joint axis orientation~     of the hindfoot bones between patients diagnosed with adult-acquired flatfoot disorder (AAFD)~     and a control group of patients without foot deformity, using weight-bearing CT technology.~   "
129770|NCT01868776|"~     The purpose of this study is to determine the effect of buffered lidocaine (a numbing~     solution) on the ability to numb patients with toothaches. Buffered anesthetic (numbing)~     solutions have shown promise in some medical and dental research. Patients presenting with~     toothaches will be given either a buffered numbing solution or a nonbuffered numbing~     solution. Neither the patient nor the operator will know which solution they will receive.~     Root canal treatment will be performed on the tooth and the ability of the buffered versus~     non-buffered numbing solutions will be compared.~   "
129771|NCT01868763|"~     Lifestyle changes often fail due to loss of motivation. Telemedicine and personal coaching~     have the potential to support lifestyle change and weight loss. Therefore, the aim of our~     randomized controlled trial was to examine the effect of telemedicine with and without~     coaching in comparison to a control group on weight loss in overweight participants.~   "
129772|NCT01868750|"~     One of the major side effects of surgery to remove the thyroid gland is transient (lasting~     for a short time) low calcium levels in the blood, or hypocalcemia. Low calcium levels can~     cause symptoms such as numbness around the mouth, tingling or cramping in the hands and feet,~     severe muscle spasms, inability to breathe, or heart rhythm (heart beat) abnormalities.~     Severe symptoms are life threatening, so it is important to start the management of these~     symptoms in the hospital. Treating low calcium levels sometimes require patients to spend a~     few extra days in the hospital.~      The human body needs vitamin D to function and stay healthy. Vitamin D helps the body get the~     calcium needed to make strong bones and teeth. The purpose of this study is to determine if~     taking vitamin D before surgery to remove the thyroid gland affects whether or not you may~     have low calcium levels after your surgery and to test the hypothesis that those who are~     given the Vitamin D before surgery will have decreased hypocalcemia and a shortened hospital~     stay.~   "
129773|NCT01868737|"~     A randomized, double blind, placebo controlled clinical trial was conducted in the neonatal~     high care unit of Tygerberg Children's Hospital (TBCH) Cape Town, South Africa for the period~     July 2011 to August 2012. The primary objective of the study was to assess the effect of~     probiotics on the incidence of NEC in high risk infants born to HIV-positive and HIV-negative~     women.~      Throughout the study period, the standard of care protocol consisted of one dose (5 drops)~     probiotic/placebo daily for 4 weeks (28 days). This provided the study group with L.~     rhamnosus GG (0.35 x 109 colony-forming units [CFU]) and B. infantis (0.35 x 109 CFU) daily.~     The control group received placebo consisting of medium chain triglyceride (MCT) oil.~     Supplementation of the probiotic/placebo was initiated when enteral feeds started. Probiotic/~     placebo supplementation was delayed/ halted in the event of: the infants being nill per os~     (NPO); when a query Necrotizing Enterocolitis (NEC) was suspected the infant continued with~     treatment until a confirmed a positive diagnosis of NEC I was made through abdominal X-ray;~     if the infant remained a query NEC and was NPO the infant did not receive probiotics/ placebo~     until the enteral feeds were commenced again. Supplementation was discontinued when~     HIV-exposed infants had a positive polymerase chain reaction (PCR) result on day 14 of life.~      All study participants received human breast milk. Both the probiotics and placebo were mixed~     with the mothers own breast milk or donor breast milk before administration via the~     orogastric tube or orally. The probiotic/ placebo was added to the breast milk by the~     researcher and two research assistants who were blinded and not involved in the routine care~     of the infants. Participants exited the study on day 28 after birth or upon discharge from~     the hospital.~   "
129774|NCT01868724|"~     This study is to collect blood and urine samples to help identify and validate protein~     biomarkers of recovery from moderate or severe acute kidney injury (AKI).~   "
129776|NCT01868698|"~     Peripheral arterial disease (PAD) is a pathological condition limiting, resulting from a~     narrowing or occlusion of the artery diameter due to aneurysms, inflammation, atherosclerosis~     and thromboembolic events. One of the main risk factors for the development of DAP is~     diabetes mellitus due to its relation to the process of atherogenesis. Thus, the objective of~     this study is to evaluate the effects of three treatment modalities for PAD on the blood flow~     velocity. It is a crossover study. Fifteen women with diabetes receive three types of~     treatment, the order defined according draw: high voltage electrical stimulation, shortwave~     diathermy and kinesiotherapy. The blood flow of the lower limb will be assessed by Doppler~     ultrasound. The hypothesis of this study is that physical therapy resources increase the~     circulation of the lower limb.~   "
129777|NCT01868685|"~     The purpose of this study is to evaluate the effect of BYM338 on muscle mass and function in~     Group III failure to wean patients, as compared to placebo controls.~   "
129778|NCT01868672|"~     The burden of tobacco use falls disproportionately on low-income populations, through high~     rates of primary smoking and exposure to secondhand smoke. The remarkable progress in~     creating smoke-free environments in the U.S. over the past two decades has left smoker's~     homes as one of the primary sources of exposure to secondhand smoke for both children and~     nonsmoking adults. Intervention research that identifies effective and practical strategies~     for reaching the minority of households that still allow smoking in the home has considerable~     potential to reduce smoke exposure, but suitable channels to reach low-income families are~     limited.~      The proposed research will systematically test an intervention designed to create smoke-free~     homes in low income households among 2-1-1 callers. During this randomized control trial,~     researchers will disseminate and evaluate a brief smoke-free homes intervention through the~     established infrastructure of a North Carolina 2-1-1 call center. 2-1-1 is a nationally~     designated 3-digit telephone exchange, similar to 9-1-1 for emergencies or 4-1-1 for~     directory assistance, that links callers to community-based health and social services. The~     main hypothesis to be tested is that a higher proportion of households in the intervention~     group will establish and maintain a smoke-free home than in the measures-only control group.~   "
129779|NCT01868659|"~     Diagnostic errors are common, but they have been largely ignored by patient safety groups.~     Diagnostic errors are often traced to physicians' cognitive biases and failed heuristics~     (mental shortcuts). We know how these faulty thinking processes lead to diagnostic errors,~     but we know little about how to resist them. Faulty thinking has plagued other high-risk,~     high-reliability professionals, such as airline pilots and nuclear plant operators. These~     professions have learned from their mistakes and have developed checklists to help prevent~     them. The medical profession has started to use checklists and time-out periods in the~     operating room and intensive care unit, but these strategies have not been used to reduce~     diagnostic errors. The most common reason that physicians fail to make the correct diagnosis~     is that they never consider it. This failure could potentially be prevented if the physician~     took a time-out to review a checklist. Our broad long-term goal is to reduce diagnostic~     errors by developing interventions that help counter faulty diagnostic thinking. The specific~     aims of this project are to (1) determine the feasibility of taking a diagnostic time-out in~     the acute outpatient setting (urgent care clinic and emergency department), (2) determine if~     new diagnostic possibilities are seriously considered as a result of the time-out and~     checklist, and (3) compare the initial differential diagnosis with the new differential~     diagnosis following the time-out, and with the discharge diagnosis documented in the medical~     record, and with the final diagnosis based on a one-month follow-up. To achieve these aims,~     the investigators will ask 5 urgent-care physicians to complete a time-out procedure for 10~     diagnostically challenging adult patients and 5 physicians will serve as controls (no time~     out) for 10 diagnostically challenging patients (total of 100 patients). The investigator~     will ask the intervention physicians to take a 2-minute time-out to review a~     complaint-specific differential-diagnosis checklist, which includes the differential~     diagnosis for 60 common presenting complaints, such as dyspnea and chest pain. The time-out~     will occur at the conclusion of the history and physical exam. We will use descriptive~     statistics and qualitative methods to characterize physicians' reactions to the time-out and~     checklists. We will use this pilot project to plan a larger study that will determine the~     risks and benefits of diagnostic time-outs and checklists.~   "
129780|NCT01868646|"~     The purpose of this study is:~        -  to assess clinical efficacy of Subetta in the combined treatment of type II diabetes~          mellitus;~        -  to assess safety of Subetta in the combined treatment of type II diabetes mellitus.~   "
129781|NCT01868633|"~     The purpose of this study is to assess the effectiveness intravenous (IV) dexamethasone when~     used as part of a multimodal regimen to manage post cesarean delivery pain.~      We hypothesize that a single dose of IV dexamethasone administered, as part of a multimodal~     analgesia after spinal anesthesia will significantly reduce post cesarean delivery opioid~     consumption and pain~   "
129782|NCT01868620|"~     The primary purpose of the protocol is to compare the current standard CXL with iontophoretic~     CXL to provide evidence in relation to the efficacy and safety in progressive keratoconus.~      Corneal collagen crosslinking (CXL) is the first surgical procedure that appears to halt the~     progression of keratoconus. In the current standard CXL, the central corneal epithelium must~     be debrided to efficiently permeate the corneal stroma with riboflavin. The epithelium~     debridement can cause severe pain, infection and stromal haze. The study hypothesis is that~     iontophorese CXL is as effective as standard CXL to stabilize a progressive keratoconus.~   "
129783|NCT01868607|"~     The objective of the study is to evaluate the reliability of the impedance data in adult~     subjects measured with five different FOT devices.~   "
129784|NCT01868594|"~     The purpose of this study is:~        -  to assess clinical efficiency of Subetta in the combined treatment of type I diabetes~          mellitus;~        -  to assess safety of Subetta in the combined treatment of type I diabetes mellitus.~   "
129785|NCT01868581|"~     This trial is conducted i Europe. The aim of this trial is to test for bioequivalence between~     two explorative formulations of insulin degludec (insulin 454) and between two explorative~     insulin degludec/insulin aspart (IDegAsp - formerly SIAC) formulations, all with or without~     buffer, in healthy male subjects. The investigated formulations are explorative, not similar~     to the proposed commercial formulation.~   "
129786|NCT01868568|"~     This trial is conducted in Europe. The aim of this trial is to compare insulin degludec and~     insulin aspart (IDegAsp) co-formulations with separately injected, simultaneous doses of~     insulin degludec (insulin 454) and insulin aspart, compared with biphasic insulin aspart 30~     (NovoMix® 30) in subjects with type 1 diabetes mellitus. Each subject will be randomised to~     four out of nine possible treatment arms. IDegAsp 40, IDegAsp 45, IDegAsp 55 and IDeg high~     concentration were explorative formulations, not similar to the proposed commercial~     formulation.~   "
129787|NCT01868555|"~     This trial is conducted in Asia. The aim of this trial is to assess the safety,~     pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the~     effect of the investigated drug on the body) of two insulin degludec/insulin aspart (IDegAsp)~     preparations and two insulin degludec (insulin 454) preparations in healthy Japanese male~     subjects. IDegAsp 45 (B) and insulin degludec (B) are explorative formulations, not similar~     to the proposed commercial formulations.~   "
129793|NCT01868477|"~     The primary purpose of this trial is to assess the effect of treatment with deferasirox~     combined with erythropoietin vs. erythropoietin alone on erythropoiesis in patients with low-~     and int-1-risk myelodysplastic syndrome.~      The addition of deferasirox to erythropoietin could lead to a potential synergism with the~     reduction of reactive oxygen species, through both the NF-kB pathway and the control of free~     toxic iron. This may create a better environment in the bone marrow for a better response~     with erythropoietin.~      This study is designed to test in a prospective way the combination of deferasirox with~     erythropoietin in term of their effect on hematopoiesis.~   "
129794|NCT01868464|"~     This is a Phase I open-label, dose escalation trial to evaluate the use of Tice® BCG as a~     challenge for future assessment of in vivo TB immunity. Subjects will be recruited from the~     target population reflecting the community at 2 VTEU sites. Enrollment will occur over 14~     months. Subjects who provide informed consent will be screened, and up to 120 eligible, HIV~     and TB uninfected subjects, 18-45 years, inclusive, will be enrolled for study interventions~     and sequentially assigned to 1 of 4 dose groups. Doses of Tice BCG from 2 to 16x10^6 cfu will~     be delivered ID in a dose escalation format to 4 groups of 30 subjects per dose group.~     Primary Objectives: 1) Evaluate the safety of different doses of ID Tice BCG for use as a~     human challenge model for TB infection. 2) Examine shedding from ID challenge sites after~     administration of different doses of Tice BCG in TB naive healthy subjects. 3) Evaluate the~     reproducibility of BCG shedding over time with both quantitative PCR and culture.~   "
129795|NCT01868451|"~     The purpose of this study is to compare the outcomes across the 4 different treatment groups.~     The investigators hope that this treatment will improve the ability to cure more patients~     with HL and also limit the long-term side effects from the treatment. Although eliminating~     radiation in cohort 4 will eliminate the risk for long-term side effects from radiation, it~     is also possible that with BV+AVD chemotherapy alone there may be an increased risk of the~     Hodgkin lymphoma coming back after initial treatment.~   "
129796|NCT01868438|"~     The purpose of this study is to compare the bioavailability of two formulations (tablets and~     granules for dispersion) of the antimalarial drug Pyramax (which is a combination of~     pyronaridine and artesunate).~   "
129797|NCT01868425|"~     This study will evaluate the effectiveness of an aggressive multimodal regimen versus~     standard multimodal for ACL repair using hamstring graft for patients having surgery in our~     outpatient surgicenter.~   "
129798|NCT01868412|"~     In recent years, salve prepared from Norway spruce (Picea abies) resin and refined honey from~     manuka myrtle (Leptospermum scoparium), has successfully been used in medical context to~     treat both acute and chronic surgical wounds. The objective of this prospective, randomized~     and controlled clinical trial is to investigate healing rate and healing time of surgical~     wounds in patients, who have undergone peripheral vascular surgery, and whose complicated~     wounds are candidate for topical treatment with the resin or honey. In addition, factors~     contributing with delayed wound healing, antimicrobial properties, safety and~     cost-effectiveness of the resin salve and medical honey will be analyzed.~   "
129799|NCT01868399|"~     Since 2009, Kaohsiung Medical University Hospital organized a medical team to provide the~     medical service for people in Solomon Islands thru Taiwan Health Center at the local. In~     addition to Malaria and pulmonary tuberculosis, the investigators also found dengue virus,~     Japanese Encephalitis virus, Chikungunya virus infections and intestinal parasitic infections~     might be the existing but overlooked and neglected medical issues in Solomon Islands. These~     infections show similarity in clinical manifestations and usually difficulty in clinical~     diagnosis, instead these infections rely on the laboratory identification with good~     laboratory quality and facility.~   "
129800|NCT01868386|"~     Radiation therapy is one of the standard treatments for men with prostate cancer who have~     detectable levels of prostate specific antigen (PSA, a prostate cancer specific marker) after~     surgery. When radiation therapy is given to patients who have an increase in PSA after~     surgery, it is called salvage radiation therapy. Currently the standard radiation therapy~     course length for this type of cancer is around 7 ½ -8 weeks. Sometimes, radiation therapy~     after prostate removal causes unpleasant side effects. A shorter course of radiation therapy,~     known as a hypofractionated course, gives fewer but higher doses of radiation than standard~     radiation.~      The purpose of this study is to test the safety of a shorter course of radiation therapy at~     progressively lower dose levels and shorter lengths of treatment (hypofractionated) with~     patients who have had their prostate removed. The study will assess whether the~     hypofractionated course works better without causing additional side effects to the remaining~     cancer cells in the prostate bed.~   "
129801|NCT01868373|"~     To confirm and extend the work of Trede and Rask-Madsen (Lancet 1989;1:1156-1160) that~     administration of a defined fecal microbiota will lead to rapid and sustained resolution of~     C. difficile associated chronic relapsing diarrhea.~      The current rationale behind FMT for CDI is that introduction of microbes from a healthy~     donor allows restoration of a normal microbial community in the diseased host with consequent~     suppression of C. difficile colonization and disease pathogenesis. The first modern use of~     FMT was reported in a 1958 case series of 4 patients with pseudomembranous enterocolitis. The~     first case of confirmed CDI treated with FMT was reported in 1983; treatment was curative.~     Until 1989, retention enemas were the most common technique for FMT. Alternative methods for~     delivering FMT have included fecal infusion via duodenal tube (1991), rectal tube (1994), and~     colonoscopy (1998). FMT for recurrent CDI has been used successfully whether administered by~     nasogastric tube, rectal administration by colonoscopy, rectal tube including~     self-administration at home by enema. FMT has proven to be remarkably effective and~     remarkably safe without any significant problems (see below and attached reviews and~     meta-analyses).~      Increasing, interest is emerging regarding the changes in the intestinal microbiota~     associated with CDI. In 2008 Chang et al. constructed small (< 200 sequences per subject) 16S~     rRNA gene libraries from the stools of 4 patients with first-time CDI and 3 patients with~     recurrent CDI. Based on 16S rRNA gene classification, they found that the fecal microbiomes~     of patients with an initial episode of CDI were similar at the phylum level to healthy~     subjects (i.e., the majority of sequences belonged to dominant fecal phyla Bacteroidetes and~     Firmicutes), while a major reduction or loss of Bacteroidetes was observed in patients with~     recurrent CDI. The loss of the Bacteroidetes was accompanied by the expansion of other phyla,~     including Proteobacteria and Verrucomicrobia, which are normally minor constituents of the~     fecal microbiota. Khoruts et al. (2010) compared the microbiota of a patient with recurrent~     CDI before and after FMT by using terminal-restriction fragment length polymorphism and~     clone-based 16S rRNA gene sequencing. Before transplantation, the patient's microbiota were~     deficient in members of Bacteroides and instead were composed of atypical fecal genera such~     as Veillonella, Clostridium, Lactobacillus, Streptococcus, and unclassified bacteria similar~     to Erysipelothrix. Two weeks after infusion of donor fecal suspension, the bacterial~     composition of her feces approached normal and was dominated by Bacteroides sp. strains.~      In 1989, Tvede and Rask-Madsen used a combination of nine normal fecal organisms to treat 6~     patients with chronic relapsing C. difficile diarrhea. These investigators cultivated 10~     strains of bacteria, including Enterococcus (Streptococcus) faecalis (1108-2), Clostridium~     innocuum (A27-24), Clostridium ramosum (A3I-3), Bacteroides ovatus (A40-4), Bacteroides~     vulgatus (A33-14), Bacteroides thetaiotaomicron (A33-12), Escherichia coli (1109), E. coli~     (1108-1), Clostridium bifermentans (A27-6), and Blautia producta (Peptostreptococcus~     productus) (1108-2) in broth for 48 h to a concentration of approximately 10 to the 9th power~     bacteria/mL. Two mL from each bacterial culture were admixed with 180 mL saline that had been~     pretreated in an anaerobic chamber for 24 h; the bacterial suspension was then instilled~     rectally. This procedure was followed promptly by a decline of C. difficile to undetectable~     levels by culture and the loss of detectable toxin from the stools. Normal bowel function was~     restored within 24 hours, and abdominal symptoms disappeared. Stool cultures and toxin assays~     for C. difficile remained negative during a year of follow-up. It is especially important to~     note that feces from none of the 6 patients contained Bacteroides sp.~   "
129802|NCT01868360|"~     The cornea is the clear front part of the eye. Corneal neovascularization, the excessive~     growth of blood vessels into the cornea, is a sight-threatening condition. Corneal~     neovascularization is also a well recognized risk factor for corneal graft failure. The~     current standard of care to prevent graft rejection includes use of topical steroids and~     medicines that suppress the immune system. These medicines do not address corneal~     neovascularization. The purpose of the study is to establish the safety and potential~     efficacy of subconjunctival injections of aflibercept (EYLEA® , marketed by Regeneron)~     injection in inducing regression of blood vessels growing into the cornea and promoting graft~     survival.~      This study is being conducted by Dr. Balamurali Ambati at the Moran Eye Center.~   "
129803|NCT01868347|"~     Analysis of the specific elastance during general anesthesia in patients treated with RARP~     (robotic assisted radical prostatectomy), to evaluate the efficacy of the preemptive~     strategy, involving recruitment maneuver and setting of 10 cmH2O PEEP before induction of~     pneumoperitoneum and trendelenburg position.~   "
129804|NCT01868334|"~     The purpose of this study is to test whether or not the 4 Pillars Toolkit increases adult~     Influenza, pneumococcal polysaccharide vaccine (PPSV), tetanus, adult diphtheria and~     acellular pertussis vaccine (Tdap/Td) vaccination rates. The vaccines are all FDA licensed~     vaccines and to be used according to national guidelines. The investigators will conduct a~     randomized cluster trial of this toolkit in diverse primary care practice with electronic~     medical records (EMRs).~   "
129865|NCT01867541|"~     Refractive outcome after cataract surgery mainly depends on the prediction of the intraocular~     lens that is implanted in the eye during surgery.~      Aim of this study is to measure the position of the lens capsule during surgery and to use~     this measurements to improve post-operative refractive outcomes.~   "
129805|NCT01868321|"~     The purpose of this international, multicenter study is to determine ventilation practice and~     outcomes of intubated and ventilated intensive care unit (ICU) patients. Ventilation~     characteristics and outcomes will be compared between patients without the acute respiratory~     distress syndrome (ARDS), patients at risk for ARDS, and patients with mild, moderate or~     severe ARDS.~      Participating centres worldwide will include adult patients undergoing mechanical ventilation~     in the ICU during a 7-day period. Patients data will be collected during the first 7 days in~     the ICU, or until ICU discharge. Follow up is until day 90. Primary endpoint is the tidal~     volume size used during mechanical ventilation. Secondary endpoints are development of ARDS~     in patients without ARDS at the onset of mechanical ventilation, worsening of ARDS in~     patients with ARDS at the onset of mechanical ventilation, pulmonary infection, other~     pulmonary complications, need for tracheostomy, extra-pulmonary complications, duration of~     ventilation, length of ICU and hospital stay, and ICU, hospital and 90-day mortality.~   "
129806|NCT01868308|"~     Our objective is to investigate the predictive value of a panel of biomarkers associated with~     two biologically plausible pathways of preterm birth: membrane breakdown and cervical~     remodeling. The investigators will obtain cervical length, cervicovaginal fetal fibronectin,~     and a panel of novel cervicovaginal biomarkers associated with cervical remodeling in a~     prospective cohort of symptomatic women with a singleton pregnancy at high risk for preterm~     birth in an effort to better risk stratify this cohort.~   "
129807|NCT01868295|"~     Tooth loss and sleep problems are common conditions in elders. Tooth loss can influence sleep~     quality by changing the shape of the lower face and upper airway. While some studies suggest~     that sleeping without dentures can worsen sleep quality in toothless elders, others suggest~     the opposite. Consequently, there are currently no evidence-based practice guidelines~     regarding whether dentures should be used at night, and dentists and doctors do not know how~     to properly advise their patients on these issues. To address this knowledge gap, over the~     past 5 years we have carried out research examining the quality of sleep of a group of~     edentulous elders. In addition, we conducted a pilot study to examine the link between~     night-time denture wear and sleep. Our results indicate that edentulous elders who wore their~     dentures at night had high levels of daytime sleepiness. Furthermore, use of dentures at~     night seemed to increase the risk of apneic events in those elders who had mild sleep~     disturbance. While intriguing, these results require confirmation in larger samples. In line~     with our previous research, the aim of the proposed study is to produce reliable evidence~     that clinical practice guidelines could be based on and which could be used by dentists and~     doctors who treat toothless elders.~      We will enroll 70 toothless elders who will be randomly assigned to wear and not wear their~     dentures at night for two periods of 30 days. Sleep studies will be conducted at the homes of~     participants. The participants will also be asked to respond to questions on sleep quality~     and oral health-related quality of life. Ultimately, the results of this study will help~     improve the health and quality of life of millions of elders in Canada and around the world.~   "
129808|NCT01868282|"~     Patients scheduled to undergo knee arthroscopy with anterior cruciate ligament repair with~     graft from the ipsilateral hamstrings and gracilis will be randomized to one of three groups.~     All patients will receive subsartorial saphenous nerve block. Along with this, Group 1 will~     receive perihamstring local anesthetic infiltration (Hamstring block), Group 2 will receive~     blockade of the anterior division of obturator nerve and Group 3 (control group) will receive~     sham injections of hamstrings and anterior division obturator nerve. All patients will~     receive co-analgesics for home discharge. The study will evaluate the efficacy of~     subsartorial saphenous nerve block alone or in combination with either hamstring block or~     obturator block with regards to postoperative analgesia especially the donor site pain and~     total analgesic consumption.~   "
129809|NCT01868269|"~     The OMS/DES study is a multinational European Trial for Children with the Opsoclonus~     Myoclonus Syndrome / Dancing Eye Syndrome.~      This trial brought on the way by specialists of the EPNS (European Paediatric Neurology~     Society), the GPOH (Gesellschaft für Pädiatrische Hematologic und Oncologie) and the SIOPEN~     (SIOP (International Society Oncology Pediatric) Europe Neuroblastoma).~      This protocol will investigate an escalating treatment schedule starting with a~     corticosteroid standard treatment with dexamethasone pulses (first step), which is followed,~     if response has been inadequate after 3 months of treatment, by the addition of CP (second~     step) and, if still no sufficient improvement, by the replacement of CP by Rituximab (third~     step). Treatment intensification is decided on the basis of standardized scoring of OMS/DES~     severity.~   "
129810|NCT01868256|"~     -  Objectives: The primary objective of this study is to evaluate the safety of an early~          discharge strategy in patients with low risk ST-elevation myocardial infarction (STEMI),~          treated with primary percutaneous coronary intervention (PPCI), compared to a~          conventional strategy.~        -  Methodology: Unicentric, randomized, controlled, non-inferiority and open label clinical~          trial. The investigators will compare an early discharge strategy (≤72 hours) with a~          conventional strategy (discharge according to treating physician's criterion). Inclusion~          criteria will be: low risk (Zwolle risk score ≤3) STEMI treated with PPCI within 24~          hours from symptoms onset. Exclusion criteria will be: arrhythmias (ventricular~          tachycardia or fibrillation, asystole, pulseless electrical activity, advanced~          atrio-ventricular block), mechanical complications (cardiac tamponade, free-wall or~          septal rupture, acute mitral regurgitation, pericarditis), severe or moderate bleeding~          (according to the GUSTO criteria), complications related to vascular access of the~          procedure, acute kidney failure, infection, heart failure. Sample size will be 1558~          subjects (n=779 per group). The investigators will study demographic, clinical,~          biochemical, echocardiographic and angiographic variables. The primary endpoint will be~          a composite of death, reinfarction, new angina, heart failure, ventricular arrhythmias,~          stroke and severe bleeding. The secondary endpoint will include each of the items of the~          primary endpoint and quality of life and functional capacity questionnaire SF-36.~          Finally, the investigators will analyze the degree of compliance with the European~          Society of Cardiology guidelines on STEMI and the rate of hospitalization-related~          complications. Follow up will be at 30 days.~   "
129811|NCT01868243|"~     DAWA is a phase 2, prospective, open-label, randomized, pilot study. The main variable to be~     observed in this study is intracardiac thrombus. There are no formal primary or secondary~     clinical efﬁcacy or safety outcomes because it is a pilot study.~   "
129886|NCT01867268|"~     -  Purpose of study : to determine the preventive effect of acetazolamide administration,~          prone positioning, and the combination of both following the neurosurgical interventions~          in lumbosacral region for cerebrospinal fluid (CSF) leak, CSF collection and wound~          dehiscence.~        -  Sample size: 144~        -  intervention groups:~             -  Group A: Acetazolamide administration for 10 days~             -  Group B: prone positioning for 10 days~             -  Group C: Acetazolamide administration and prone positioning for 10 days~             -  Group D: no intervention~        -  Period of study: Autumn 2012 to the end of winter of 2015~   "
129812|NCT01868230|"~     The overall goal of this randomized controlled trial is to test the efficacy of a culturally~     and linguistically modified, individually tailored lifestyle intervention to reduce excess~     gestational weight gain (GWG), increase postpartum weight loss, and improve maternal~     metabolic status among overweight/obese Hispanic women. Specific aims are to evaluate the~     impact of the intervention on 1) GWG and postpartum weight loss, 2) pregnancy and postpartum~     biomarkers of insulin resistance (i.e., glucose, insulin, HbA1c, HOMA, leptin, adiponectin),~     3) postpartum biomarkers of cardiovascular risk (i.e., blood lipids, blood pressure), 4)~     offspring outcomes (i.e., anthropometric measures and biomarkers of insulin resistance), and~     5) to evaluate the cost-effectiveness of the intervention per average incremental improvement~     in the outcome variables. Overweight/obese Hispanic women will be recruited in early~     pregnancy (around 10 wks gestation) and randomly assigned to a Lifestyle Intervention (n=150)~     or a Comparison Health and Wellness (control) Intervention (n=150). The intervention will~     utilize exercise (R01NR011295) and dietary intervention materials (R18DK067549) culturally~     adapted for Hispanics and shown to be efficacious in our previous controlled trials in this~     ethnic group. Multimodal contacts (i.e., in-person, telephone counseling, and mailed~     print-based materials) will be used to deliver the intervention during pregnancy (~12 wks~     gestation to delivery) continuing into postpartum (~6 wks to 6 mos postpartum); follow-up~     will continue for one year postpartum. Targets of the intervention are to achieve Institute~     of Medicine Guidelines for GWG and postpartum weight loss; ACOG guidelines for physical~     activity through increasing walking and developing a more active lifestyle; and reduction in~     total calories by following a balanced healthy diet in compliance with American Diabetes~     Association guidelines. The intervention draws from Social Cognitive Theory and the~     Transtheoretical Model and includes strategies for partner and/or family support to address~     the specific social, cultural, and economic challenges faced by underserved Hispanic women.~     Measures of compliance will include actigraphs and Hispanic food frequency questionnaires.~     The proposed project builds upon the expertise of the investigative team in conducting~     randomized controlled trials of exercise interventions among Hispanic pregnant women (R01~     DK074876) and dietary interventions among low-income Hispanics with type 2 diabetes (R18~     DK0658850) and can readily be translated into clinical practice in underserved and minority~     populations.~   "
129813|NCT01868217|"~     -  To Investigate the Prevalence of Capsular Bag Distention Syndrome~        -  To Analyze Influencing Factors of Capsular Bag Distention Syndrome~   "
129814|NCT01868204|"~     Adoption, twin and family studies have reported that obesity has a strong heritable component~     and in particular, it has been suggested that BMI in adults is due to genetic influence~     rather than shared family environment. Binge eating in obese patients was described.~     Therefore, it has been proposed that binge eating disorder (BED) may contribute to obesity in~     some individuals.~      Pharmacological studies reported that topiramate plays an important role in the treatment of~     binge eating disorder. It has been observed improvement of co-occurring binge eating disorder~     in patients receiving topiramate for treatment of mood disorders. In addition, topiramate was~     associated with anorexia and weight loss in clinical trials with epilepsy patients. Also,~     topiramate has been demonstrated efficacy in pilot and controlled studies for binge eating~     disorder (BED) associated with obesity. Genetic studies will be important to elucidate the~     mechanism by which putative susceptibility variation in candidate genes influences in~     pharmacological improvement of binge eating disorder in obese patients treated with~     topiramate.~      Connecting drug response with relevant functional DNA variants and differences in brain~     regions represents the ultimate goal for pharmacogenetic research playing an important role~     in advancing this understanding. The use of brain imaging combined with genetics can aid in~     understanding the pathophysiological mechanism of the disease. Additionally, brain imaging~     has the ability to bridge between preclinical research and human pharmacological studies.~      This will be a naturalistic clinical study designed to analyze the effect of genetic variants~     and neurofunctional brain areas associated with food craving in patients with obesity and~     binge eating disorder responders to topiramate.~      Hypothesis: The use of topiramate in obese subjects with binge eating disorder is associated~     with a differential gene variants and different activation brain areas in subjects that~     showed a reduction of food craving and weight lost.~   "
129815|NCT01868191|"~     The aim of the present study is to assess before, as well as 6 and 12 months following a~     therapy with benfotiamine the influence of therapy on intraepidermal nerve fiber density~     (skin biopsy) and neuropathic symptoms and deficits in people with type 1 or 2 diabetes~     mellitus and diabetic sensomotoric neuropathy.~   "
129816|NCT01868178|"~     The aim of this study was to estimate the relationship between BIS and Spectral Entropy~     values and any explicit or implicit memory or dreams recall during desflurane anaesthesia.~   "
129817|NCT01868165|"~     Older adults are at increased risk of high blood pressure and cognitive decline. High blood~     pressure itself also increases risk of cognitive decline. A particular type of blood pressure~     lowering drug (a calcium channel blocker(CCB)) may lower risk of dementia in younger adults~     but there is no clear evidence of it's impact in those >=80. It is important that we know~     whether CCB use impacts on cognitive function in this age group. This study will compare~     change in cognitive function in those taking CCBs to those not taking CCBs.~   "
129818|NCT01868152|"~     This study aimed to find a quick and timely way to predict the individual variation of~     efficacy of opioid analgesic during the operation and postoperative analgesia in Chinese~     patients undergoing elective surgeries. Methods: female patients receiving elective surgery~     under general anesthesia were recruited into this study. At the time of routine intravenous~     anesthetic induction we observe the efficacy of opioid analgesic including analgesic effect,~     effects on Narcotrend index, sedative effect, effects on respiratory system, and aslo effects~     on cardiovascular system. Then we record the consumption of of opioid analgesic during the~     operation and postoperative analgesia. Also we record the side effect of the opioid~     analgesic.~   "
129819|NCT01868139|"~     The goal of this study is to evaluate the safety and efficacy of endoscopic spray cryotherapy~     using the CSA Medical, Inc. truFreeze System for patients with previously untreated~     early-stage cancer (T1a, N0, M0) who are ineligible or refuse conventional therapy including~     surgery, chemotherapy, radiation therapy, and endoscopic resection.~      It is hypothesized that one of the two following outcomes will occur:~        1. Complete response to therapy: complete tumor eradication confirmed through histologic~          examination of biopsy specimens from the targeted esophageal tissue site;~        2. Stable disease: tumor remission is not attained, but disease progression is halted.~   "
129820|NCT01868126|"~     The purpose of this study is to investigate the safety and efficacy of four concentrations of~     DE-117 ophthalmic solution.~   "
129821|NCT01868113|"~     The purpose of this study is to find out whether adjunct treatment with inhaled~     corticosteroids lead to faster improvement and reduce mortality of children under 5 years of~     age admitted to hospital with ALRI.~   "
129822|NCT01868100|"~     Advanced cancer has an adverse effect in virtually all dimensions of patients' lives~     (physical, psychosocial, spiritual, familial, role function). One of the less frequently~     explored effects of cancer is its impact on personal finances and the contribution of~     financial-related distress to overall suffering and quality of life. Financial issues have~     been recently found to be the second most frequent source of distress identified by cancer~     patients in a community cancer center context (22%).~      In the context of continuous increased health care costs, it is likely that the frequency of~     health care related financial problems will keep rising. The relative contribution of these~     adverse financial events in advanced cancer patients to overall patient distress is not well~     assessed and this is particularly true in France. The main objective of this work is to~     determine the association between financial distress and quality of life of patients with~     advanced cancer in a Public General Hospital and in a Comprehensive Cancer Center. A~     secondary objective is to characterize the frequency and intensity of financial distress~     reported by French cancer patients and their impact on their quality of life.~   "
129825|NCT01868061|"~     This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will~     evaluate the efficacy and safety of lebrikizumab in participants with asthma whose disease~     remains uncontrolled despite daily treatment with inhaled corticosteroid (ICS) therapy and at~     least one second controller medication. Participants will be randomized in 1:1:1 ratio to~     receive double-blind treatment with either lebrikizumab (high or low) or placebo,~     administered as subcutaneous (SC) injection every 4 weeks for 52 weeks, in addition to their~     standard-of-care therapy. This will be followed by a 52-week double-blind active treatment~     extension. Participants who were assigned to placebo during the placebo-controlled period of~     the trial will be re-randomized at Week 52 to receive blinded SC lebrikizumab 37.5 milligrams~     (mg) or 125 mg every 4 weeks from Weeks 53 to 104. The anticipated time on study treatment is~     104 weeks. After study treatment, all participants will complete a 20-week safety follow-up.~   "
129826|NCT01868048|"~     The purpose of this study is to determine the effective dose range and to demonstrate a~     non-effective dose range of Sativex compared with placebo in relieving symptoms of spasticity~     due to multiple sclerosis.~   "
129827|NCT01868035|"~     This is a multicenter study for the long-term follow-up of surviving patients who are~     expected to complete or who have completed at least two years of follow-up after treatment~     with Iodine I 131 Tositumomab (BEXXAR) on studies CP-97-011, CP-98-025, CP-99-032, or~     CP-99-036. All patients will be assessed for survival and disease status, including~     subsequent therapy for Diffuse Large B-cell Non-Hodgkin's Lymphoma (NHL), and for long-term~     safety. Additionally laboratory evaluations consisting of a thyroid stimulating hormone (TSH)~     level and a complete blood cell (CBC) count with a differential and platelet count will be~     obtained annually. Additionally, patients who remain in long-term response following Iodine I~     131 Tositumomab treatment will be followed for response and progression.~   "
129828|NCT01868022|"~     This phase IB trial aims to identify anticancer activity of GSK3052230 in subjects with~     malignancies with abnormal dependence on FGF pathway signaling. Combination doses of~     GSK3052230 with standard of care chemotherapy in the first and second line or greater setting~     of metastatic squamous non-small cell lung cancer (NSCLC) and first line malignant pleural~     mesothelioma subjects will be studied in the 3+3 dose-escalation design. This will be a~     multi-arm, multicenter, non-randomized, parallel-group, uncontrolled, open-label Phase IB~     study designed to evaluate the safety, tolerability and preliminary activity of GSK3052230 in~     combination with paclitaxel + carboplatin (Arm A), in combination with docetaxel (Arm B), or~     in combination with pemetrexed + cisplatin (Arm C). Approximately 70 subjects will be~     enrolled in the study (approximately up to 120 may be enrolled).~   "
129829|NCT01868009|"~     Subjects who have not used the ELLIPTA™ inhaler nor the DISKUS™ inhaler in the past 6 months~     will be screened to participate in the study. Subjects will have an equal chance of being in~     any of the following two groups (1:1 allocation). One group will be dispensed the ELLIPTA~     inhaler at Visit 1 to use during the first period (once daily for 5 to9 days), and the DISKUS~     inhaler at Visit 2 to use during the second period (twice daily for 5 to 9 days). The other~     group will be dispensed the DISKUS inhaler at Visit 1 to use during the first period (twice~     daily for 5 to 9 days), and the ELLIPTA inhaler at Visit 2 to use during the second period~     (once daily for 5 to9 days). At the end of the second period, subjects will complete the~     study by answering 7 questions to assess their preference of device attributes and dosing~     regimens between the two inhalers.~      The null hypothesis for device preference for a specific attribute is that 50% subjects~     express a preference in that attribute for ELLIPTA and 50% do NOT express a preference in~     that attribute for ELLIPTA, i.e., the odds for preferring ELLIPTA to not preferring ELLIPTA~     is unity.~      The null hypothesis for dosing regimen preference is that 50% subjects express a preference~     of once daily dosing and 50% do not express a preference of once daily dosing (prefer twice~     daily dosing or have no preference).~   "
129830|NCT01867996|"~     This will be a randomized single sequence open label study. This study is designed to~     determine if chronic dosing with efavirenz (EFZ) will have an effect on the pharmacokinetics~     (PK) of intravenously-administered retosiban in healthy volunteers. The study consists of~     screening (28 days), treatment (1 dosing session) and follow-up (7 to 14 days) period, and~     the total duration of study participation for each subject will be approximately 8 weeks.~     During the treatment period, subjects will be admitted to the clinical research unit the day~     before dosing (Day 1) and will remain until completion of the last assessment on Day 20. All~     subjects will receive on Day 1, a 6 milligrams (mg) bolus of retosiban for 5 minutes (min),~     followed by a 6 mg/hour (hr) infusion for 12 hrs. On Day 2, a washout day will occur. On Days~     3-17, subjects will receive EFZ 600 mg once daily in the evening. On Day 18, subjects will~     receive a 6 mg bolus of retosiban for 5 mins, followed by a 6 mg/hr infusion for 12 hrs plus~     a 600 mg dose of EFZ.~   "
129831|NCT01867983|"~     This randomized controlled trial compares the effectiveness for both smoking cessation and~     weight control of two alternative combined interventions offered via telephone quitline, as~     compared to standard of care quitline treatment addressing cessation alone. The interventions~     to be compared are cessation treatment alone versus cessation treatment combined with weight~     control treatment added either simultaneously or sequentially.~   "
129832|NCT01867970|"~     Rationale: Physical activity is an important factor for a healthy lifestyle. Although~     physical activity can delay complications and decrease the burden of the disease in~     chronically ill persons, their level of activity is often far from optimal. Many~     interventions have been developed to stimulate physical activity, with disappointing results.~     New in this field is the use of technology. Human persuasion (for example guidance by a~     practice nurse) can be enhanced by technological persuasion. Therefore a monitor and feedback~     tool, consisting of an accelerometer linked to a smart phone and webserver, has been~     developed and tested.~      Objective: The main objective of this study is to measure the effects of the monitoring and~     feedback tool embedded in a Self-management Support Program on physical activity. The~     secondary objective is to measure the effect on self-efficacy, quality of life and health~     status. In addition a process evaluation will be conducted.~      Study design: A three-armed cluster randomised controlled trial will be conducted with 240~     patients from 24 general practices. Randomisation level is the practice. The following~     conditions will be compared: 1) Tool and Self-management Support Program; 2) Self-management~     Support Program; 3) Care as usual. Outcome measures will be measured at t0 (before the start~     of the intervention), t1 (after 6 months, at the end of the intervention) and t2 (after 9~     months).~      Study population: 120 People with COPD and 120 people with Diabetes type 2 (aged 40-70)~     treated in primary care will be included from 24 GP practices.~      Intervention: Spread over a period of six months patients in condition 1 and 2 have to visit~     the practice nurse for 3-4 times for physical activity counselling. Specific activity goals~     will be set that are tailored to the individual patient's preferences and needs. On top of~     this, patients in condition 1 will be instructed to use the monitoring and feedback tool in~     daily life. Patients in condition 3 will not be exposed to any intervention.~      Main study parameters/endpoints: Primary outcome: physical activity measured with a physical~     activity monitor (PAM). Secondary outcomes: quality of life, general self-efficacy, exercise~     self-efficacy and health status.~   "
129834|NCT01867944|"~     The primary aim of this study is to test a non-medicinal technique for chronic constipation.~     The core of the technique is to have subjects repeatedly press on and massage their perineum~     before defecation to fragment and soften the stool before it passes the lower rectum and~     anus. The technique will be evaluated as a complementary treatment to standard treatment of~     constipation (patient educational materials about treatments such as stool softeners,~     laxatives fiber supplements, and increased exercise). Although this technique has been~     studied for other conditions (for example in pregnant women to prevent birthing-related~     injuries), and it is recommended anecdotally by some physicians, this would be the first time~     it will be studied for chronic constipation in a randomized, controlled clinical trial.~      $50 dollars in compensation is provided for about an hour of participant's time.~   "
129835|NCT01867931|"~     The purpose of this study is to characterize and compare epithelial damage in patients with~     erosive esophagitis and non-erosive reflux disease.~   "
129836|NCT01867918|"~     In this study the investigators will include colo-rectal cancer (CRC) patients starting last~     line of standard palliative chemotherapy. Eligible patients include patients with KRAS~     mutation starting line or KRAS wild type starting line treatment. Standard treatment today~     for these patients is chemotherapy only and median overall survival (OS) is about 10 months.~     The hypothesis is that local treatment in addition to systemic treatment will increase time~     to progression, progression free survival and overall survival compared to patients who~     receive systemic chemotherapy only. The investigators experience with local treatment of~     liver metastases in CRC patients is that side-effects of treatment in general are minor,~     although gastric bleeding have been observed after stereotactic body radiation therapy.~   "
129837|NCT01867905|"~     Sepsis is a significant cause health care expenditure and carries an extremely high rate of~     morbidity and mortality if not treated appropriately. From 1979 to 2000, sepsis resulted in~     over 10 million admissions to hospital in the United States with a mortality rate of 17.9 to~     27.8 percent. In Canada, it is estimated that the incidence of sepsis from 2008-2009 was~     103.3 per 100,000 per year.~      Advances in the multifaceted management of sepsis in recent years have resulted in improved~     clinical outcomes. However, the cornerstone of sepsis management relies on the prompt~     administration of appropriate antibiotics. Current clinical practice suggests that antibiotic~     administration can be delayed up to 45 minutes in order to obtain blood cultures, whose~     results have a profound impact on the type and duration of antimicrobial therapy.~     Unfortunately, this recommendation is based on very little evidence and the investigators~     have found that potential life-saving treatment is often delayed in order to abide by it.~     Furthermore, recent data suggest that mortality could be increased by approximately 5% by~     delaying antibiotic administration for that time period.~      The investigators therefore wish to organize a prospective, multi-centre trial in order to~     identify the effect of antibiotic administration on blood culture positivity in patients~     presenting with severe sepsis or septic shock. Other objectives will be to elucidate which~     patient factors, including age, co-morbid conditions and clinical presentation, as well as~     antibiotic choice will affect blood culture results.~      This study will be conducted in the emergency departments at St. Paul's Hospital (SPH),~     Vancouver General Hospital (VGH), Lion's Gate Hospital (LGH), Surrey Memorial Hospital,~     Montreal General Hospital and Royal Victoria Hospital. Patients identified for the~     aforementioned conditions will be treated as per routine hospital protocol. If the patient is~     deemed eligible for the study, a second set of blood of blood cultures will subsequently be~     drawn ideally between 30 and 60 minutes after the administration of antibiotic therapy.~     Subject demographic data will be collected pertaining to age, comorbid immunocompromised~     conditions, vital signs, laboratory tests pertaining to end organ dysfunction, suspected~     source of sepsis, the type antibiotics administered and the timing of antimicrobial~     administration with respect to the second set of blood cultures taken.~      Our hypothesis is that blood culture positivity in patients presenting with severe sepsis and~     septic shock will not be altered significantly by antibiotic therapy. If so, our study would~     strongly argue against delaying life-saving therapy and would thus greatly improve patient~     care in our local emergency rooms. If incorrect, our study would be the first to demonstrate~     the benefit of obtaining blood cultures before antibiotic therapy and would strengthen~     current recommendations.~   "
129838|NCT01867892|"~     The primary end point is to evaluate the 9-month progression free survival rate and safety~     profile after FOLFIRINOX versus GOFL induction chemotherapy followed by concurrent~     chemoradiotherapy in locally advanced pancreatic cancer.~      The secondary end points are to evaluate the disease control rate, overall survival time,~     toxicity profile and compliance after induction chemotherapy and concurrent chemoradiotherapy~     as well as the disease control rate after inductional chemotherapy alone in locally advanced~     pancreatic cancer. Translational research including pharmacogenomic study and biomarker study~     will also be done concomitantly.~   "
129839|NCT01867879|"~     The purpose of this study is to evaluate the cardiac safety of TAS-102 in patients with~     advanced solid tumors.~   "
129840|NCT01867866|"~     The purpose of this study is to compare the pharmacokinetics of trifluorothymidine (FTD) as a~     component of TAS-102 with FTD alone.~   "
129841|NCT01867853|"~     To evaluate the performance of volume responsiveness in predicting the outcome of mechanical~     ventilation weaning in critically ill patients.~   "
129842|NCT01867840|"~     In recent years, ion channels have emerged as new therapeutic targets for pain. Among these~     channels, ASICs (Acid Sensing Ion Channels) are of particular interest because they are~     directly activated by extracellular acidity, which is a major cause of pain. Indeed, many~     painful conditions such as ischemia, inflammation, tumor development or tissue incision are~     accompanied by tissue acidification. ASIC are excitatory ion channels that are expressed in~     neurons, including nociceptive sensory neurons. In humans, the use of amiloride, a~     nonspecific inhibitor of ASICs, has demonstrated their role in the perception of pain induced~     by subcutaneous injections of acidic solutions. ASICs thus appear as new candidates capable~     of mediating pain in humans. A growing number of data suggests that, in addition to protons,~     ASICs may also be activated by one or more endogenous compounds produced during inflammation.~     The purpose of this research project is to identify these compounds by testing the effects of~     human inflammatory exudates on ASICs activity. The discovery of such compounds would~     definitely validate ASICs as novel therapeutic targets for pain treatment in humans~   "
129843|NCT01867827|"~     The aim of the study is to train patients with Parkinson's Disease to increase activity in a~     brain area that is involved in the control of motor functions with the use of a technique~     called real-time fMRI neurofeedback (NF) along with regular physical exercise. This will be a~     randomised and controlled clinical trial to evaluate the benefits of a novel treatment. The~     investigators expect NF training along with physical exercise practise to better improve~     motor functions compared to physical exercise alone.~   "
129887|NCT01867255|"~     The purpose of the study is to determine whether a significant and predictable change in~     bioavailability of extended-release venlafaxine occurs following Roux-en-Y gastric bypass.~   "
129971|NCT01866150|"~     This cross-sectional, non-interventional, retrospective chart review will compare the~     efficacy and safety of biologic monotherapy and biologic and methotrexate combination therapy~     in patients with rheumatoid arthritis who have had an inadequate response to prior treatment~     with disease-modifying anti-rheumatic drugs including methotrexate. Data will be collected~     from patients who have been on first-line biologic treatment for at least 6 months.~   "
129844|NCT01867814|"~     Laparoscopic surgery is frequently associated with hemodynamic changes due to~     pneumoperitoneum (PnP). Those complex hemodynamic changes are difficult to predict and~     occasionally they require active therapeutic interventions or even interruption of the~     surgical procedure.~      One of the main hemodynamic effects of PnP is a decrease in cardiac output due to reduction~     of venous return and cardiac preload. Although it has been shown repeatedly that waveform~     variables are good predictors of cardiac output response to volume loading, the prediction~     hemodynamic response to decrease of preload is more complex.~      The investigators hypothesize that waveform variables will predict cardiac output changes~     resulting from PnP. Particularly, augmented values of waveform variables before PnP will be~     associated with a larger decrease of cardiac output after establishing PnP.~   "
129845|NCT01867801|"~     The purpose of this Registry is creating a database management that allows continuous~     monitoring characteristics, evolution, prognostic indicators and management of patients~     undergoing coronary angioplasty in Portuguese Hospitals, and identify the appropriateness of~     clinical and interventional practice recommendations for diagnosis and treatment of coronary~     disease and monitoring its evolution.~   "
129846|NCT01867788|"~     The Harvard Biomarker Study is a Harvard-wide, longitudinal case-control study designed for~     discovering, replicating, and developing biomarkers for Parkinson's disease and Alzheimer's~     disease. High-quality biosamples and high-resolution clinical phenotypes are tracked at three~     visits over a two-year period for more than 2,000 individuals with early-stage PD, MCI/AD,~     and controls without neurologic disease.~      The present Ancillary Longitudinal CSF Collection Study (short HBS2) is an ancillary study~     to the parent Harvard Biomarker Study. HBS2 is funded by the NINDS. In HBS2, 75 participants~     are more intensely studied and followed over a three-year time period. Clinical data and~     blood biospecimens are collected every six months and four annual CSF collections are~     performed. Biospecimens and clinical data are deposited into the NINDS PD Biomarkers Program~     (PDBP) Repository and the Data Management Resource (DMR) and are accessible through the PDBP~     DMR website.~   "
129847|NCT01867775|"~     The purpose of this study is to determine whether mirtazapine is effective in the treatment~     of sleep disorders in Alzheimers disease.~   "
129848|NCT01867762|"~     The purpose of this study is to assess the effectiveness and safety of JNJ 49095397 in~     participants with symptomatic moderate to severe chronic obstructive pulmonary disease~     (COPD).~   "
129849|NCT01867749|"~     The purpose of this study is to conduct a randomized pilot trial in a sample of 60 women who~     meet criteria for Major Depressive Disorder (MDD) 1-18 months after a perinatal loss to~     demonstrate the feasibility of the proposed recruitment methods and research design, of the~     therapist training methods, and of delivering the adapted Interpersonal Psychotherapy group~     treatment.~      The investigators would like to examine preliminary evidence for the following hypotheses:~        -  Perinatal-loss specific IPT-G will be more acceptable to women who experience MDD~          following perinatal loss than will Coping with Depression (CWD).~        -  Perinatal-loss specific IPT-G will result in reduced time to remission from MDD and~          reduced depressive symptoms relative to CWD.~        -  Perinatal-loss specific IPT-G will result in increased social support and social~          functioning, reduced couple distress, and reduced grief relative to CWD.~   "
129850|NCT01867736|"~     A prospective, multicentric, randomized controlled trial to assess the safety and performance~     of the Passeo-18 Lux Paclitaxel releasing PTA balloon catheter versus the uncoated Passeo 18~     PTA balloon catheter for the treatment of stenosis, restenosis or occlusion of the~     infrapopliteal arteries.~   "
129851|NCT01867723|"~     Being diagnosed and treated for cancer is usually associated with severe side effects and~     symptoms. Cancer patients can have difficulty to manage the symptoms as a result of treatment~     which may cause i) an interruption or cessation of cancer treatment ii) can have a negative~     impact on patients' quality of life (QoL). Family caregivers (FCs) of cancer patients are~     often the primary source of social and emotional support for patients, and play major roles~     in how well patients manage with the consequences of illness and treatment. Thus, FCs are~     clinically important, since supporting FCs indirectly supports patients.~      To help both cancer patients and their FCs to manage their symptoms, our center has developed~     WebChoice now called Connect, an internet based support system that extends traditional~     health services into cancer patients' homes. Connect provides individualized symptom~     management support, illness relevant information, and communication with a clinical nurse~     specialist in cancer care, as well as with other cancer patients and their FCs over the~     Internet. The objectives of this interdisciplinary research project are to test main and~     interaction effects of providing Connect to patients, to FCs or both simultaneously on 1)~     primary patient outcomes in terms of symptom distress, QoL, depression, fatigue and sleep 2)~     Primary FC outcomes in terms of symptom distress, QoL, depression, fatigue, sleep and FC~     burden 3) Secondary, or intermediate, patient and FC outcomes in terms of self-efficacy~     social support, and self-reported health care utilization.~   "
129852|NCT01867710|"~     The purpose of the study is to determine the safety and clinical benefit of the combinations~     of abiraterone acetate and prednisone or abiraterone and dexamethasone in prostate cancer~     patients. Prednisone will be given at one of three different dose schedules. Dexamethasone~     will be given at one dose schedule. This will include looking at what side effects occur and~     how often they occur. In addition the impact of the study drug on quality of life and pain~     will be evaluated. The study will also collect data on subsequent treatment of patients after~     they come off the study drug (up to a maximum of 5 years after the study starts). By~     analyzing blood samples, the study aims to identify if some markers could help to understand~     if the treatment with abiraterone is effective and also help to understand if patients can~     become resistant.~   "
129888|NCT01867242|"~     This is a multi-center trial involving the University of Minnesota, Ohio State University~     Comprehensive Cancer Center, and Roswell Park Cancer. Cigarette smokers who are eligible will~     enter a Camel Snus sampling phase. Smokers interested in continuing with the study after the~     sampling phase will undergo a 2 week baseline assessment phase and will then be randomized to~     one of the five experimental conditions for 8 weeks. Tobacco use patterns, subjective~     responses to product, and nicotine and toxicant exposure will be assessed.~   "
129889|NCT01867229|"~     Relation between chemotherapy and amennorhea~   "
129972|NCT01866137|"~     The aim of the PsyCo Study is to determine whether psychological Stress has an influence on~     copeptin levels.~   "
129853|NCT01867697|"~     Nordic randomized phase II trial which evaluates whether biweekly cetuximab with alternating~     FOLFIRI and mFOLFOX6 is more effective than biweekly cetuximab with continuously FOLFIRI in~     patients with potential resectable KRAS wildtype metastatic colorectal cancer.~      All patients will be randomized to biweekly cetuximab 500 mg/m2 in combination with arm A)~     FOLFIRI (irinotecan 180 mg/m2 IV, leucovorin: 400 mg/m2 IV, 5FU bolus: 400 mg/m2 IV and 46~     hours 5FU infusion of 2400 mg/m2 every 2 weeks) or arm B) FOLFIRI alternating with FOLFOX6~     (Oxaliplatin: 85 mg/m2 IV, leucovorin: 400 mg/m2 IV, 5FU bolus: 400 mg/m2 IV and 46 hours 5FU~     infusion of 2400 mg/m2 every 2 weeks) .~      Primary objective: response rate (RECIST 1.1) in patients with with potential resectable KRAS~     wildtype metastatic colorectal cancer.~      Secondary objectives: Resection rate, PFS, OS, Quality of life, tolerability. Biomarker~     evaluation to measure plasma biomarkers, Tumour blocks and sequential serum and plasma will~     be collected to search for markers that may predict efficacy including respectability and~     safety.~   "
129854|NCT01867684|"~     Stroke, head injury and other forms of brain injury are a major cause of physical,~     psychological and social disability in the adult population. Psychological distress is common~     following brain injury, but the evidence base for specific psychotherapeutic methods in this~     population is limited, and standard treatment approaches may not be suitable. Recently there~     has been a growing interest in positive psychology - the study of wellbeing, positive~     emotions and characteristics, and personal growth. The investigators believe that positive~     psychotherapy interventions may be beneficial after acquired brain injury, to reduce~     psychological morbidity. Because such interventions have not previously been applied in this~     population, the investigators propose to conduct a pilot randomised controlled trial to~     examine the feasibility of a brief positive psychotherapy intervention in an out-patient~     setting. This project will produce essential information to allow us to plan future~     full-scale clinical trials in this area.~   "
129855|NCT01867671|"~     This is a randomized, double-blind, placebo-controlled, multi-center study comparing peanut~     oral immunotherapy (OIT) to placebo in the induction of tolerance and desensitization in~     peanut-allergic children. Eligible participants with peanut allergy will be randomly assigned~     to receive either peanut OIT or placebo for 134 weeks followed by peanut avoidance for 26~     weeks.~   "
129856|NCT01867658|"~     The objective of this clinical study is to evaluate the safety of the Progel® PALS, including~     the Progel® Extended Applicator Spray Tips, in sealing or reducing intraoperative air leaks~     in patients undergoing video assisted or robotic assisted thoracoscopic (VATS/Robotic)~     surgeries.~      The data collected in this clinical study will supplement the Approved PMA P010047 Progel®~     PALS product.~   "
129857|NCT01867645|"~     Critical illness polyneuropathy and/or myopathy (CIPNM) is a severe complication of critical~     illness. Retrospective data suggest that early application of IgM-enriched intravenous~     immunoglobulin (IVIG) may prevent or mitigate CIPNM. Therefore, the primary objective was to~     assess the effect of early IgM-enriched IVIG versus placebo to mitigate CIPNM in a~     prospective setting.~   "
129858|NCT01867632|"~     The goal of the present study is to definitely determine whether the use of acellular dermal~     matrix (ADM) during primary cleft palate repair decreases the rate of fistula formation.~     Although individual studies have described promising advantages to its use in cleft palate~     surgery, no consensus currently exists. Without concrete evidence, one must question the~     whether the increased cost, time and potential patient risk (human derived tissue) to~     patients justifies its use in primary cleft palate repair.~   "
129859|NCT01867619|"~     The primary objective of the phase II study is to assess the objective (CR+PR) response rate~     at a maximum tolerated dose (MTD) of Lomustine in combination with Temozolomide and~     Thalidomide after the first cycle (8 weeks) in patients with metastatic melanoma in the~     brain. Secondary objectives include the evaluation of objective response in the extracranial~     metastases, duration of response and overall survival.~   "
129860|NCT01867606|"~     This randomized pilot phase II trial studies how well serum bovine immunoglobulin protein~     isolate works in improving quality of life and post-operative recovery in patients with~     cancer of the female reproductive tract after undergoing surgery. Serum bovine immunoglobulin~     may help provide nutrition to patients who are not able to eat or digest ordinary food. This~     may improve the quality of life of patients with gynecological cancer and help them recover~     more quickly from surgery.~   "
129861|NCT01867593|"~     This research study is a prospective pilot study. The purpose of a pilot clinical study is to~     obtain preliminary data to support the reason for doing a larger clinical trial on testing~     the clinical effectiveness of an investigational intervention. Investigational means that~     the role of MET-PET scans is still being studied and that research doctors are trying to find~     out more about it. It also means that the FDA has not approved this intervention for your~     type cancer.~      In this research study, the investigators are evaluating whether or not MET-PET scans have~     value in predicting response to standard chemoradiation therapy in participants with~     newly-diagnosed glioblastoma. A standard treatment for glioblastoma is treatment with a~     combination of radiation therapy and chemotherapy with the drug temozolomide.~      In PET scans, a radioactive substance is injected into the body. The scanning machine finds~     the radioactive substance, which tends to go to cancer cells. With standard PET scans, the~     radioactive substance used is FDG. FDG goes to many areas of the normal brain which makes it~     difficult for use in distinguishing brain tumors from normal tissue.~      For the PET scans in this research study, the investigators are using a radioactive substance~     called MET, instead of the standard substance FDG. MET gets absorbed by cancer cells but not~     by normal brain and therefore may be better than FDG in evaluating brain tumors and therefore~     may be better than FDG in evaluating brain tumors and their response to treatment.~      In this research study, participants will receive standard chemotherapy and radiation therapy~     for glioblastoma as well as standard MRI scans. In addition, participants will undergo~     L-[Methyl]-11C Methionine Positron Emission Tomography (MET-PET) scans twice. The first~     MET-PET scan will occur after enrollment but prior to radiation therapy. The second MET-PET~     scan will occur approximately one month after completion of radiation therapy.~   "
129862|NCT01867580|"~     The purpose of this study is to examine the effectiveness of the Veraflo with Prontosan vs~     VAC in wounds that require operative debridement.~   "
129863|NCT01867567|"~     Women undergoing their first second or third cesarean section will be randomized into two~     groups. One group will have the abdominal bandage removed at 6 hours post-surgery and the~     other group will have the bandage removed at 24 hours. Staple removal will be at 5 - 7 days~     for both groups. The incision will be inspected at the time of staple removal. The 2 groups~     will be compared for incision disruption and infection. Also, the women will be asked about~     their satisfaction for time of bandage removal.~   "
129864|NCT01867554|"~     Intellectual disability (ID) occurs in 2 to 3 % of the general population but the cause is~     identified only in 30 to 60% of cases.~      The purpose of this study is to indentify genes involved in ID with new genetics tools~     (SNP-arrays, next generation sequencing...) and establish genotype-phenotype correlations.~   "
129866|NCT01867528|"~     Small bowel obstruction is a common reason for surgical admission. Most common reason for~     small bowel obstruction is adhesions, which account up to 70-80 % of small bowel~     obstructions. Large proportion of adhesive small bowel obstructions may be treated~     nonoperatively, but up to 50-60% may need surgical intervention. Current golden standard for~     surgical intervention is open adhesiolysis. Recently, retrospective studies have provided~     encouraging results of laparoscopic adhesiolysis for small bowel obstructions. However, no~     prospective randomized trials have been carried out and retrospective series carries a high~     risk for patient selection and bias. Although in general laparoscopy has been associated with~     shortened hospital stay, less pain and reduced mortality, laparoscopic adhesiolysis for small~     bowel obstruction has been reported to cause iatrogenic small bowel lesions up to 7% of~     patients. Aim of the study is to compare open adhesiolysis to laparoscopic adhesiolysis. The~     investigators hypothesis is that laparoscopic adhesiolysis is safe, will shorten the hospital~     stay, and reduce mortality compared to open approach.~   "
129867|NCT01867515|"~     The purpose of this program of research is to understand the perception of the dynamic~     spectral properties of speech by hearing-impaired listeners, with the long-term goal of~     improving speech understanding by these individuals in adverse listening conditions. The~     proposed research compares the performance of normally-hearing and hearing-impaired listeners~     on measures of speech understanding in the presence of different types of signal distortion~     and speech understanding of signals with enhanced spectral dynamics. A computational model~     based on the amount of potential information available in speech will be used to quantify~     differences in speech intelligibility due to hearing status and stimulus characteristics.~   "
129868|NCT01867502|"~     Exercise is considered a way to benefit the health of unhealthy and healthy individuals. This~     is confirmed by different scientific researches, in which people who participated improve~     their health. The present study will be conducted to test the hypothesis that vildagliptin~     associated with metformin may have more impact in improving glucose variability after a~     sub-maximal exercise test, as compared to glibenclamide. Our general aim will be to evaluate~     glucose variability after the submaximal exercise test under the treatment with vildagliptin~     or glibenclamide. The specific aims of this study are to evaluate the oxidative stress,~     endothelial function, metabolic and cardiovascular responses to exercise under the treatment~     with vildagliptin or glibenclamide. All these responses are important in patients with~     Diabetes Mellitus type II. Allied to the patient's routine treatment (metformin), they will~     receive orally a second drug, to take in 12 weeks. The patients will be raffled to take one~     of the two drugs that act on glycemia, that are called vildagliptin (50 mg of this drug twice~     a day) and glibenclamide (5 mg once a day during the first week and later you will increase~     to 5 mg twice a day). The metformin drug will continue be used.~      Patients who meet the eligible criteria for the study will first make the test of the maximum~     effort, to determination of peak oxygen consumption (VO2peak) and ventilatory thresholds.~     Forty eight hours after this test, patients will be allowed to do the pre-drugs protocol that~     will be given in three consecutive days as explained below.~        -  Day 1: Begin a 24-hour urinary collection, perform vascular doppler ultrasound to~          evaluate endothelial function and then the glucose sensor will be inserted~          subcutaneously (begin continuous glucose monitoring system - CGMS evaluation);~        -  Day 2: End the 24-hour urinary collection, submit to the submaximal test (blood~          collection at baseline, 15 and 30 min of the session, and 60 min after recovery). On the~          same day, the patients will begin 24h ambulatory blood pressure monitoring (24h-ABPM).~        -  Day 3: Removal of the glucose sensor; end of the 24h ABPM, randomization. This same~          protocol, except the randomization will be repeated at the end of the 12 week treatment.~   "
129869|NCT01867489|"~     This qualitative study explores how patients deal with the side effects from chemotherapy at~     their home, what factors and ideas influence their symptom self-management and how~     professional caregivers contribute to the management of their symptoms at home. Data are~     collected through semi-structured interviews with adult patients treated with chemotherapy~     and analysed using a Grounded Theory approach.~   "
129870|NCT01867476|"~     The purpose of this study is to determine the feasibility and accuracy of an automated~     adherence monitoring system, and to compare the variance between urine and oral fluid~     riboflavin levels when specimens are obtained 'as usual' and after a one-hour inter specimen~     interval.~   "
129871|NCT01867463|"~     Background:~      - Malaria is a disease that is spread by mosquitoes. Researchers are looking for a vaccine~     that can prevent mosquitoes from transmitting malaria to people. They want to test a vaccine~     called Pfs25-EPA/Alhydrogel that may help stop malaria parasites from developing in~     mosquitoes. When a mosquito bites a vaccinated person, the vaccine should prevent parasites~     from developing in the mosquito. As a result, the mosquito will not spread malaria to the~     next person it bites. However, the vaccine will not directly prevent people vaccinated from~     getting sick with malaria. Researchers want to test this vaccine in people who live in rural~     Mali. To do so, the study will compare the symptoms and the blood tests of the participants~     who receive either the study vaccine or a regular hepatitis B/meningococcal vaccine.~      Objectives:~      - To see if Pfs25-EPA/Alhydrogel is a safe and effective malaria vaccine.~      Eligibility:~      - Healthy volunteers between 18 and 45 years of age who live in Bancoumana, Mali.~      Design:~        -  Participants will be screened with a medical history, physical exam, and blood tests.~        -  Participants will be separated into two groups. One group will have Pfs25-EPA/Alhydrogel~          to test the study vaccine. The other group will have the regular Hepatitis B vaccine~          series, meningococcal vaccine.~        -  In the study vaccine group, participants will have either a lower dose or a higher dose.~          For the lower dose, they will have two vaccine shots over 1 year. For the higher dose,~          they will have four vaccine shots over about 14 months.~        -  In the other vaccine group, participants will have the Hepatitis B vaccine series,~          meningococcal vaccine according to the standard dose schedule.~        -  All participants will provide regular blood samples for testing during the study.~        -  Participants who develop malaria during the study will participate in evaluation of~          transmission and parasite development of malaria parasite from the person to mosquito~          via transmission assays. They will allow mosquitoes (that have no diseases) to bite them~          in a controlled clinic setting. This will let researchers see if the vaccine can stop~          the mosquitoes from carrying malaria to other people.~   "
129872|NCT01867450|"~     Background:~      - Diesel fuel is the most commonly used fuel to power cars and trucks worldwide. However,~     diesel exhaust fumes can have harmful effects on the body. Researchers are interested in~     studying how diesel exhaust exposure can affect lung health. To study these effects,~     researchers will look at employees of a diesel truck engine testing facility in China. Some~     workers at this facility are exposed to high levels of diesel exhaust. This study will~     compare tests and monitoring information from a group of highly exposed workers and a similar~     group of unexposed comparable controls.~      Objectives:~        -  To study the effects of diesel exhaust on lung health.~      Eligibility:~        -  Participants will be drawn from a diesel truck engine testing facility and other~          workplaces in China.~        -  Individuals at least 18 years of age who work in workshops with diesel fuel.~        -  Individuals at least 18 years of age who work in workshops that do not use diesel fuel.~      Design:~        -  Depending on what type of factory study subjects work in, participants will wear~          personal air pumps and small badges on their clothing on one or more days. This~          equipment will measure particles, chemicals, and other compounds in the air. This~          information plus other information collected in the study including workplace practices~          will be used to estimate exposure to diesel exhaust among study subjects.~        -  Participants will provide a number of study samples. These samples include blood, urine,~          and sputum. To collect other samples, participants will also have a mouth rinse, cheek~          cell scrapes, and nasal cell scrapes. They will also have a physical exam.~        -  Treatment will not be provided as part of this study. Participants will receive~          financial compensation for participation in the study.~   "
129873|NCT01867437|"~     Background:~      - RM-493 is a drug that stimulates parts of the brain that control eating and metabolism. It~     has helped to reduce body weight and improve insulin sensitivity in lab tests. However, it is~     not fully known whether RM-493 causes weight loss by just decreasing appetite or by~     increasing metabolism or both. Researchers want to see how RM-493 affects metabolism and~     hormones that affect the metabolic rate. They also want to see how RM-493 affects appetite by~     assessing feelings of hunger and fullness. They will study this drug in people who are obese~     but are otherwise in good health.~      Objectives:~      - To see how RM-493 affects metabolic rate and appetite in obese but otherwise healthy~     individuals.~      Eligibility:~      - Individuals between 18 and 50 years old who are obese (body mass index between 30 and 40~     kg/m2) but are otherwise healthy.~      Design:~        -  The study consists of three phases. The first phase is the screening visit. The second~          phase is an 8-day inpatient stay. The final phase is a follow-up phone call one week~          after the end of the second phase.~        -  Participants will be divided into two groups. One group will receive the study drug~          first, followed by a placebo. The other group will receive the placebo followed by the~          study drug. The study drug and placebo will be given under the skin for 3 days each by a~          small device (OmniPod) that normally is used to give insulin to people with diabetes.~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. They will also meet with a dietitian. The OmniPod device will~          be demonstrated before use.~        -  Participants will have the following procedures during their 8-day inpatient stay:~        -  Daily exercise routine (walking on treadmill) after setting a comfortable pace (miles~          per hour) during an exercise test~        -  Wear physical activity monitors~        -  Body composition study to measure amounts of fat and muscle~        -  Calorie controlled study diet~        -  Study drug/placebo dose through the OmniPod (Days 2 through 4 and 5 through 7)~        -  Metabolic rate studies using a cart or the metabolic chamber~        -  Daily blood samples~        -  Urine collection for 24 hours~        -  Questions about weight history and appetite~        -  About a week after the inpatient stay, participants will have a followup phone call to~          ask about any side effects from the study.~   "
129874|NCT01867424|"~     Background:~      - Prostate cancer is the most common cancer type among men. Some prostate cancers respond to~     hormonal therapy. However, some cell characteristics of other prostate cancers cause it not~     to respond as well to these therapies. Researchers want to see if gadoxetate, a contrast~     agent used to help identify damaged liver tissue, can help tell these types of prostate~     cancer apart. It may be able to identify if a man has a type of prostate cancer for which~     hormone therapy may not work as well.~      Objectives:~      - To see if gadoxetate can help identify different types of prostate cancers during imaging~     studies.~      Eligibility:~      - Men at least 18 years of age who have prostate cancer. Participants will be having surgery~     to either remove the prostate or take tumor tissue samples.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood samples~          will be collected.~        -  Participants will have a magnetic resonance imaging (MRI) scan of the lower torso. They~          will receive gadoxetate during the MRI scan.~        -  Participants who have surgery will have a sample of their tumor cells collected. Those~          who have a biopsy will provide cells from this biopsy for study.~        -  Treatment will not be provided as part of this study.~   "
129875|NCT01867411|"~     Background:~      - Smoking is a difficult habit to quit, and some people find it more difficult to quit than~     others do. Nicotine is the substance in cigarettes that makes smoking so addictive. Nicotine~     changes some patterns of brain activity, and smokers have differences in brain activity when~     compared to non-smokers. Some genes make it more likely that a person will become addicted to~     smoking. Researchers want to study how nicotine interacts with genes and brain activity. This~     may help develop better treatments to help people quit smoking.~      Objectives:~      - To develop a test of nicotine dependence, using brain activity and genetic analysis, which~     may be useful in predicting success in smoking cessation and in the development of new~     smoking cessation treatment targets.~      Eligibility:~        -  Main group: Current smokers between 18 and 55 years of age who are seeking treatment to~          quit.~        -  Comparison group: Current smokers between 18 and 55 years of age who are not seeking to~          quit.~        -  Comparison group: Healthy former smokers between 18 and 55 years of age.~        -  Comparison group: Healthy nonsmoking volunteers between 18 and 55 years of age.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood samples~          will be collected.~        -  The three comparison groups will have one magnetic resonance imaging (MRI) scan session.~          They will have tests of thinking, concentration, and memory both inside the scanner, and~          while sitting in front of a computer.~        -  Current smokers who are trying to quit must be willing to undergo a course of nicotine~          treatment that includes weekly counseling (for 12 weeks) and e-cigarettes. Participants~          will attempt smoking abstinence and will have a total of 6 MRI scanning sessions. They~          will do thinking, concentration, and memory tasks inside and outside of the scanner.~        -  For smokers, the first scanning session will take place before they attempt to quit.~          This will be a baseline scan. The second scanning session will take place 48 hours after~          having their last real cigarette. After this scan, they will use electronic cigarettes~          to help quit their habit.~        -  After using e-cigarettes for two weeks, smokers will have a third scan session.. They~          will then gradually taper their use of the electronic cigarettes over the course of~          three weeks, at which point they will be nicotine abstinent.~        -  After about 5 weeks of abstinence, they will have the fourth scan. The fifth scan will~          be approximately 6 months after start of the study, and the final scan will take place~          at about 1 year from the study start.~        -  Smokers will continue to receive support on quitting smoking until the study ends at~          about 1 year.~   "
129876|NCT01867398|"~     Background:~      - Some children and teenagers have conditions known as conduct disorders. They often have~     long-term chronic behavior problems, such as defiant behavior or violence. Conduct disorders~     are often treated with antipsychotic medication. Researchers want to study two types of newer~     antipsychotics (aripiprizole and risperidone) for children and adolescents with conduct~     disorders. They will look at how these drugs affect brain activity. To do so, they will give~     brain activity tests using magnetic resonance imaging (MRI). The tests will compare the~     results from healthy volunteer children and teens to those of others with behavior problems.~      Objectives:~      - To see how atypical antipsychotics affect brain activity of children and teenagers with~     conduct disorders.~      Eligibility:~        -  Children and teenagers between 10 and 18 years of age who have a conduct disorder and~          are taking aripiprizole.~        -  Children and teenagers between 10 and 18 years of age who have a conduct disorder and~          are taking risperidone.~        -  Children and teenagers between 10 and 18 years of age who have a conduct disorder and~          are not taking an atypical antipsychotic.~        -  Healthy volunteers between 10 and 18 years of age.~      Design:~        -  Participants will be screened with a physical exam and medical history.~          Parents/guardians will be asked questions about their child s feelings, experiences, and~          behavior. Participants will also answer questions about their feelings and moods.~        -  This study will involve two visits. Each visit will involve MRI scanning.~        -  At the first visit, participants will have memory and thinking tests. The tests will~          involve making decisions or playing games. Some of these tests will use MRI scanning to~          look at brain activity.~        -  The second visit will be 3 to 5 months after the first visit. The tests from the first~          visit will be repeated.~   "
129877|NCT01867385|"~     Background:~      - Fatigue is a common and often disabling symptom in people with chronic liver disease. Its~     causes are not well understood. Sleep disturbance may play a role in people with cirrhosis,~     but these factors have not been studied in people with other stages of liver disease. This~     study will look at the body's circadian rhythms (internal clock) to see if problems with~     these rhythms can contribute to fatigue. It will look at the causes and mechanisms of fatigue~     in people with chronic liver disease by comparing people with and without fatigue.~      Objectives:~      - To study reasons for fatigue in people with chronic liver disease.~      Eligibility:~        -  <TAB>Individuals at least 18 years of age who have chronic liver disease.~        -  <TAB>Participants with or without fatigue may enroll.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will have a~          2-day inpatient stay for the study.~        -  For the 7 days before the inpatient stay, participants will keep a sleep diary. They~          will record any caffeine or alcohol consumption, medicines, exercise, and sleep or naps.~          They will also wear an actigraph to measure their activity levels.~        -  During the inpatient stay, participants will answer questions about fatigue and sleep~          habits. They will have regular blood tests for 24 hours. Their body temperature will~          also be monitored. During the night, they will have a sleep study to look at how well or~          poorly they sleep.~        -  Treatment will not be provided as part of this study.~   "
129890|NCT01867216|"~     The main purpose of this study is to determine the safety of LY2922470, taken as oral~     capsules, once or twice daily for approximately 28 days, in participants with diabetes. It~     also aims to determine how long the drug stays in the body and how it affects blood sugar~     levels. A screening appointment is required within 28 days before the start of the study and~     a follow up appointment is required approximately 14 days after the last study dose is taken.~   "
129878|NCT01867372|"~     Background:~      - Participants in the Baltimore Longitudinal Study of Aging are being studied to examine~     changes in brain structure and function over time, and to determine if these changes can~     predict the likelihood that an individual will develop thinking and memory impairments such~     as Alzheimer s disease later in life. Imaging studies and neuropsychological testing have~     been conducted on current participants, and new participants are being recruited to the~     study. To develop better treatments and therapies for aging-related memory loss and other~     disorders, researchers are interested in determining whether early prediction of thinking and~     memory impairments are accurate and in evaluating factors that affect these predictions.~      Objectives:~      - To use imaging studies and tests of thinking and memory to determine early markers of~     Alzheimer s disease and other cognitive impairments.~      Eligibility:~      - Current participants and new recruits to the Baltimore Longitudinal Study of Aging.~      Design:~        -  Participants will be screened with a full medical history and physical examination, as~          well as blood and urine tests.~        -  Participants will have testing visits as directed by the study researchers. All~          participants will have tests as part of their an initial enrollment in the study, and~          may be asked to return yearly, 2 years later, or 4 years later for repeated tests.~        -  At each visit, participants will have brain imaging scans (including magnetic resonance~          imaging and/or magnetic resonance spectroscopy to measure brain structure and function,~          and positron emission tomography to study blood flow in the brain) to evaluate brain~          structure and function. Participants will also take tests of memory and problem-solving~          skills.~        -  Treatment will not be provided as part of this protocol.~   "
129879|NCT01867359|"~     Background:~      - Researchers are interested in learning more about dementia and its causes. They want to~     look at the genetic basis of dementia. Identifying genetic aspects of dementia may help~     provide better tests and treatments for it. It may also show rare gene variants that can~     cause or alter a person's risks for developing dementia. This study will look at people who~     have dementia, their family members, and healthy volunteers.~      Objectives:~      - To study genetic influences on dementia.~      Eligibility:~        -  Individuals who have been diagnosed with dementia.~        -  Family members of individuals who have been diagnosed with dementia.~        -  Healthy volunteers at least 18 years of age.~      Design:~        -  Participants will be interviewed and answer questions about their medical history. They~          will also provide general information on the relatives' medical histories.~        -  Participants will provide a blood sample for genetic testing.~        -  Participants will remain on the study for up to 10 years. They will have regular visits~          to monitor their brain health and function.~        -  Treatment will not be provided as part of this study.~   "
129880|NCT01867346|"~     Background:~      - The Baltimore Longitudinal Study of Aging (BLSA) is a long-term study of human aging. To~     see how the brain changes with age, researchers will study BLSA participants who are at least~     60 years old. In particular, researchers are looking for early markers of possible~     Alzheimer's disease and other conditions that cause memory loss. To do so, they will give~     tests of memory and brain function, and stay in close contact with participants.~      Objectives:~      - To study cognitive changes that occur in normal aging and in people who develop memory~     problems.~      Eligibility:~      - Individuals at least 60 years of age who are participating in the BLSA.~      Design:~        -  There are three parts to this study. These study procedures will be done under the usual~          BLSA guidelines.~        -  Participants will take paper and pencil tests. The tests measure skills such as~          language, attention, memory, and problem solving. They will also ask questions about~          emotions and feelings.~        -  Participants will give the name and phone number of a person who knows them well and~          sees them often. Researchers will ask this person to fill out questionnaires on the~          effects of aging on the participant. These questions will monitor the participant's~          memory and ability to function independently.~        -  Participants will have regular phone calls between study visits. These calls will help~          to keep their information up to date.~        -  Participants will continue on this study for as long as they are able to participate.~   "
129881|NCT01867333|"~     Background:~      - Enzalutamide is a hormone therapy that is used to treat advanced prostate cancer. It is~     given after chemotherapy and surgery to help the body destroy the cancer cells. A new~     possible way of treating prostate cancer is using a vaccine that may help stimulate the~     immune system. It will help white blood cells recognize and kill the cancer cells in and~     around the prostate. Researchers want to see whether this vaccine, given with enzalutamide,~     is more effective at treating advanced prostate cancer than enzalutamide alone.~      Objectives:~      - To compare the safety and effectiveness of enzalutamide with and without vaccine therapy~     for advanced prostate cancer.~      Eligibility:~      - Men at least 18 years of age who have advanced castration-resistant prostate cancer.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Imaging studies will be used to monitor the cancer before~          treatment.~        -  Participants will be separated into two groups. One group will have enzalutamide and the~          study vaccine. The other group will have enzalutamide alone.~        -  All participants will take enzalutamide once a day. They will take the drug during~          4-week cycles of treatment.~        -  Treatment will be monitored with frequent blood tests and imaging studies. Participants~          will continue to take the study drug for as long as the cancer does not grow and the~          side effects are not severe.~        -  The vaccine group of participants will also have the new study vaccine. They will have a~          single injection on the first day of the first study cycle. There will be regular~          booster injections afterward. There will be one on day 15 of the first cycle, the first~          day of the second cycle. The vaccine will then be given every 4 weeks for the next four~          cycles, and then every 12 weeks (every 3 cycles) thereafter. Participants will continue~          to have the study vaccine for as long as the cancer does not grow and the side effects~          are not severe.~   "
129882|NCT01867320|"~     Background:~      - Human T-cell lymphotropic virus type 1 associated myelopathy/tropical spastic paraparesis~     (HAM/TSP) is an infection of the spinal cord. The infection is caused by a virus that has~     been known to cause cancers like leukemia and lymphoma. It causes a weakening of the legs.~     Researchers want to see if raltegravir, a drug for treating human immunodeficiency virus~     (HIV), can be used to treat HAM/TSP. They will see if the drug can reduce the amount of virus~     in the blood of people with HAM/TSP.~      Objectives:~      - To see if raltegravir can reduce the viral load of people with HAM/TSP.~      Eligibility:~      - Individuals at least 18 years of age who have HAM/TSP.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood samples~          will be collected. Imaging studies will be performed. A lumbar puncture will also be~          taken.~        -  Participants will take the study drug twice a day for 6 months. They will note each dose~          in a study diary, as well as any side effects.~        -  At the 6-month visit, participants will stop taking the study drug. They will have a~          physical exam and blood samples, as well as other tests.~        -  Participants will have two further exams 9 months and 15 months after starting the study~          drug. They will have a physical exam and blood samples, as well as other tests.~   "
129883|NCT01867307|"~     Single center, 14-day, open-label trial to examine the effect of 25 mg q.d. empagliflozin on~     kinetics of renal glucose reabsorption in patients diagnosed with type 2 diabetes mellitus~     and healthy controls~   "
129884|NCT01867294|"~     This randomized phase II trial studies how well giving spironolactone works in preventing~     rash in patients with cancer that has spread to other places in the body and are receiving~     panitumumab and cetuximab. Spironolactone may prevent endothelial growth factor receptor~     (EGFR) inhibitor-induced skin rash.~   "
129885|NCT01867281|"~     The purpose of this study is to determine the effect of aspirin desensitization on symptoms~     and immunologic profile of patients with aspirin-exacerbated respiratory diseases (AERD).~   "
129891|NCT01867203|"~     Patients needing lipid lowering therapy will be recruited before initiation of the treatment.~     For each patient, total and LDL cholesterol levels before start of therapy will be measured.~     One, three and six months after his/her first visit, when steady-state will be reached, for~     each included patient, the cholesterol levels will be re-assessed in order to evaluate the~     response to statin therapy calculated as the amplitude of cholesterol reduction. The aim is~     to assess the association between patient's genotype and the response to statin therapy.~   "
129892|NCT01867190|"~     This study will assess the safety and efficacy of intra-arterial infusion and intramuscular~     injection of an autologous, bone marrow-derived stem cell preparation (ASCT01) versus placebo~     in patients with critical limb ischemia who have exhausted all medical and surgical~     therapeutic options. The safety and tolerability will be evaluated by regular monitoring of~     the general physical condition, vital signs, and the occurrence of AE and SAE, respectively.~     Furthermore, the standard biochemical and blood variables (red and white blood cell counts,~     Hb, Ht, platelets, sodium, potassium, chloride, calcium, phosphor, ASAT, ALAT, bilirubin,~     total protein, albumin, AP, cholesterol (LDL,HDL), triglycerides, urea and creatinine,~     immunoglobulins, HBA1c, C-peptide) will be checked before the treatment as well as 30 and 90~     days after the treatment.~   "
129893|NCT01867177|"~     The purpose of this study is to conduct a cross-site evaluation of the Kaiser Permanente's~     Community-based Interventions to Increase HIV Testing and HIV Care Utilization Program,~     designed to support community-based interventions to reduce the number of new HIV cases and~     to increase HIV care acquisition and maintenance in minority communities disproportionately~     affected by the HIV epidemic. This effort builds on the President's National Strategy for HIV~     Prevention and recent research documenting the importance and efficacy of test and treat~     and treatment as prevention approaches. Hence, goals of this important and novel work will~     focus on the following objectives:~        1. identification of HIV infection among recently infected adolescents and adults~        2. improved access to HIV care, particularly among newly diagnosed adolescents and adults~      To achieve these objectives, the following outcomes are expected from grantee programs:~        1. increased HIV testing among populations at risk for HIV~        2. improved health care utilization among HIV infected adults and adolescents~      This initiative has been undertaken by Kaiser to affect HIV at a population level via~     community approaches to prevention, intervention and care in minority communities most~     affected by HIV (e.g. gay, African American, and Latino communities). The University of~     California, San Diego has developed and will oversee a cross-site evaluation of Kaiser~     grantee programs funded under this initiative. Each site will have a treatment and comparison~     group, and will conduct follow up surveys with their participants three and six months after~     their interventions.~   "
129894|NCT01867164|"~     The purpose of this comparative study is to evaluate the efficacy of an ovule with triple~     active agents (terconazole, clindamycin and fluocinolone) versus another ovule with triple~     active agents (nystatin, metronidazole and fluocinolone) in the treatment of symptoms caused~     by the presence of vaginitis (inflammation of the vagina) or bacterial vaginosis~     (polymicrobial, nonspecific vaginitis associated with positive cultures of Gardnerella~     vaginalis and other anaerobic organisms and a decrease in lactobacilli).~   "
129895|NCT01867151|"~     Gluten free diet (GFD) is now being tested in patients affected by schizophrenia, autism and~     multiple sclerosis, making GFD a possible therapeutic weapon not only for celiac disease or~     gluten sensitivity. In this protocol we investigate the effect of GFD in patients affected by~     burning mouth syndrome (BMS), a disease of unknown origin characterized by oral and~     especially tongue burning sensation, deeply decreasing the quality of life of patients~   "
129896|NCT01867138|"~     The objective is to evaluate the effectiveness of empiric treatment with cefazolin versus to~     vancomycin in newborn infants with presumptive clinical signs of hospital acquired bacterial~     sepsis probably caused by Coagulase-negative staphylococcus.~      The investigators hypothesized that newborn infants with the presumptive diagnosis of~     nosocomial sepsis who received cefazolin as empiric treatment would have a clinical outcome~     not inferior to that of those treated with vancomycin.~   "
129897|NCT01867125|"~     This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will~     evaluate the efficacy and safety of lebrikizumab in participants with asthma whose disease~     remains uncontrolled despite daily treatment with inhaled corticosteroid (ICS) therapy and at~     least one second controller medication. Participants will be randomized in 1:1:1 ratio to~     receive double-blind treatment with either lebrikizumab (high or low) or placebo,~     administered subcutaneously (SC) every 4 weeks for 52 weeks, in addition to their~     standard-of-care therapy. This will be followed by a 52-week double-blind active treatment~     extension. During double-blind active treatment extension period, all participants will~     receive SC injection of lebrikizumab from Week 53 to Week 104. The anticipated time on study~     treatment is 104 weeks. After study treatment, all participants will complete a 20-week~     safety follow-up.~   "
129898|NCT01867112|"~     Individuals of advanced age undergo both physical and cognitive deterioration. The aim of~     this study is to explore the connection between level of physical activity and health~     parameters, quality of life, and frailty.~   "
129899|NCT01867099|"~     Ablation of atrial fibrillation (AF) using pulmonary vein isolation is employed when patients~     do not respond favorably to medical therapy. Successful procedures are accomplished in the~     majority of patients, but the outcome after many years of follow-up after ablation is~     unknown.~   "
129900|NCT01867086|"~     This is a Phase II study of Vigil™ autologous tumor cell vaccine integrated with~     carboplatinum. All patients will have Vigil™ prepared and stored from ovarian tumor cells~     obtained at the time of primary surgical debulking. Patients meeting eligibility criteria~     will receive either carboplatinum alone (AUC 6/30 minute infusion) or carboplatinum (AUC 5/30~     minute infusion) and taxol (175 mg/m2/3 hour infusion) one day prior to Vigil™ 1.0 x 10e7~     cells/intradermal injection, once every 3 weeks.~   "
129913|NCT01866904|"~     THis study is intended to provide contemporary data on the burden of disease in patients 1 to~     3 years post-MI, including a description of patient characteristics, current treatment~     patterns, rate of major CV events, and healthcare resource utilization in a 'real world'~     patient population at high atherothrombotic risk.~   "
141106|NCT01720329|"~     The goal of this study is to assess the feasibility of randomizing residents of long-term~     care facilities to either probiotics or placebo to assess whether probiotics can reduce~     influenza and other viral laboratory confirmed respiratory infection.~   "
129901|NCT01867073|"~     OPB-51602 is a novel oral small molecule STAT3 inhibitor developed by Otsuka Pharmaceutical~     Company, Ltd, and is currently undergoing clinical investigation at the National University~     Health System (NUHS), Singapore. The proposed correlative pharmacodynamic and pharmacogenetic~     biomarker study is initiated and funded by the investigators, and will be conducted in~     conjunction with the extension phase I protocol of OPB-51602 in patients with advanced solid~     tumours (Study code 266-09-801-01/ DSRB protocol B/09/514). All biomarker and pharmacogenetic~     samples will be collected, stored and analysed at the local laboratory of the study site~     (Cancer Science Institute, National University Health System, Singapore, Dr Boon-Cher Goh).~   "
129902|NCT01867060|"~     This propsective study aims to compare the diagnostic yield of a Personal Heart Rhythm~     Monitor (PHRM) with an automated cardiac event recorder (ACER) to detect paroxysmal Atrial~     Fibrillation PAF). The investigators hypothesise that the PHRM, used intermittently for 3~     months, will detect significantly more cases of PAF than the ACER, used continuously for one~     week.~      A case-control sub-study will identify individuals with confirmed PAF, and matched~     individuals with no evidence of PAF, to identify potential serum biomarkers for PAF.~      A further case-control study will assess markers of left atrial function in patients with PAF~     and their matched controls.~      Another case-control sub-study will determine the significance of frequent Atrial Premature~     Beats (APBs) in the development of AF over a one year period.~   "
129903|NCT01867047|"~     The purpose of this study is to determine the effects of Angiotension Converting Enzyme~     Inhibitors (ACE-I) during surgery and in the immediate postoperative period for patients~     undergoing elective total hip or knee arthroplasty.~   "
129904|NCT01867034|"~     It is hypothesized that patients with low pre-PCI serum levels of sRAGE should receive DES~     implantation and/ or procedures taken to increase serum levels of sRAGE and/ or decrease the~     serum levels of AGE.~      The purpose of this pilot study is to afford invasive cardiologists with additional evidenced~     based information to guide their decision as to which patients should receive a BMS or DES~     for coronary implantation.~      The objectives of the study are to determine whether or not:~        1. Patients with low pre-PCI serum levels of sRAGE who receive bare metal stents develop~          restenosis~        2. Patients with high pre-PCI serum levels of sRAGE who receive bare metal stents will have~          reduced risk of the development of restenosis~        3. Patients with low pre-PCI serum levels of sRAGE who receive drug eluting stents will~          have an increased risk of the development of restenosis~   "
129905|NCT01867021|"~     Demonstrate non-inferiority of the post-vaccination (Day 22) Hemagglutination inhibition (HI)~     Geometric Mean Titers (GMTs) of trivalent, inactivated, subunit influenza vaccine (TIV) over~     the corresponding GMTs of the comparator vaccine for all three strains, in healthy adults~     aged 50 years and above.~      Demonstrate non-inferiority of the percentages of subjects achieving seroconversion in~     antibody titers at Day 22 in the TIV group over the corresponding percentages of subjects in~     the comparator group for all three strains, in healthy adults aged 50 years and above.~   "
129906|NCT01866995|"~     The purpose of this study is to investigate the efficacy of Phytotherapy Raylis (Ginseng~     Root Powder 50 mg, False Ginseng Root Powder 50 mg, Codonopsis Root Powder 50 mg, Astragalus~     Membranaceus Root Powder 50 mg, Epimedium Alpinum Herbal Extract 100 mg) In Congestive~     Processes Of The Pelvic Organs (Prostatostasis) In Congestive Processes Of The Pelvic Organs~     (Prostatostasis)~   "
129907|NCT01866982|"~     Premature babies can be very sick and have bleeding in the brain. Giving babies more blood~     before cutting the umbilical cord by delayed cord clamping or umbilical cord milking has been~     shown to reduce the risk of bleeding in the brain. This may be related to improving perfusion~     to the brain. However, some studies suggest that delayed cord clamping may not increase~     hemoglobin or blood volume in babies delivered by cesarean section. Milking the umbilical~     cord may give more blood in babies delivered by Cesarean Section may improve perfusion and~     reduce bleeding in the brain.~   "
129908|NCT01866969|"~     This clinical trial studies quality of life in caregivers of hospitalized older patients with~     cancer.~   "
129909|NCT01866956|"~     The KSADS-COMP will facilitate identification of comorbid psychiatric and substance use~     diagnoses frequently missed in clinical practice, and improve adolescent treatment outcomes.~     The self-administered version of the KSADS-COMP can also be used cost-effectively in schools~     and juvenile justice settings where there is a growing interest in early identification and~     referral of youth in need of mental health services. The KSADS-Bridge assessment tool with~     its RDoC neurocognitive tasks, when completed with the self- or clinician administered~     KSADS-COMP, will help to create cross-talk between the DSM and RDoC diagnostic perspectives,~     and begin to generate a database on the relationship between RDoC constructs and treatment~     outcomes across a range of diagnostic categories.~   "
129910|NCT01866943|"~     Total hip arthroplasty (THA) is a procedure associated with perioperative blood loss,~     requiring blood transfusions in some patients. The major cause of this blood loss is due to~     surgical trauma that induces the clotting cascade and fibrinolysis. Several previous studies~     and meta-analyses have shown that tranexamic acid is an effective antifibrinolytic agent that~     reduces blood loss in a variety of situations. Tranexamic acid given in an intravenous form~     has been extensively studied and shown to be efficacious in cardiothoracic, spine surgical~     procedures as well as total knee arthroplasty (TKA) and THA. Similarly, topical tranexamic~     acid has been associated with decreased blood loss in cardiac surgeries as well. Recently,~     results from a prospective randomized study on the topical use of tranexamic acid in total~     knee arthroplasty found it to be effective for reducing postoperative blood loss. Taking all~     of the above into consideration we have proposed a study to evaluate effects of topical~     application of tranexamic acid on postoperative blood loss and blood transfusion on patients~     undergoing total hip arthroplasty. The aim of this study is to evaluate the efficacy of the~     topical application of tranexamic acid on blood loss in patients undergoing a primary~     unilateral total hip arthroplasty.~   "
129911|NCT01866930|"~     To evaluate Sustained Virologic Response at post treatment Week 12 (SVR12)following treatment~     with Lambda/RBV/DCV in chronic HCV GT-1, -2, -3 or -4 subjects co-infected with HIV-1~   "
129912|NCT01866917|"~     Study the effect of the Transversis Abdominis Plane (TAP) block on pain after surgery for~     obese women undergoing laparoscopic or robotic gynecologic procedures.~   "
129914|NCT01866891|"~     Chronic kidney disease (CKD) is associated with high level of peripheral arterial disease~     (PAD). This could lead wounds, infections then amputations or deaths by impairment of the~     peripheral cutaneous perfusion. Medical therapies are presently unable to cure, but only slow~     down these disorders. Impact of exercise and lower extremity PAD rehabilitation is decreased~     by the significant inactivity of the chronic hemodialysis patients. Recently, many studies~     have shown several various favorable effects of the perdialytic physical activity. There is~     currently no data about effects of the perdialytic activity on the lower extremity perfusion.~     The aim of this clinical study is to show the impact of three months perdialytic cycling on~     the microcirculation, in chronic hemodialysis patients. Primary outcome will be the increase~     of cutaneous perfusion, assessed by measuring transcutaneous oxygen pressure (tcPO2) on about~     twenty patients.~   "
129915|NCT01866878|"~     Sensory disorders in patients with multiple sclerosis are among the most common symptoms~     encountered.~      A functional impairment based on sensory disorders of the hand. The hand is a sensory organ~     that transmits the cerebral cortex protopathic sensitive information, proprioceptive or~     epicritiques. The view-hand association plays an important role in the understanding of the~     environment. Its exploratory use remains an essential and voluntary basis. The process of~     recognition of the object passes through manipulation, but operates instantaneously. The~     brain is able to do a quick summary of the information it receives to determine the nature of~     the manipulated object. The exploration takes a posteriori, the brain can then determine the~     details component object (texture, shape, composition, temperature and weight).~      Neurophysiological mechanisms that would explain the analgesic effects of transcutaneous~     electrical nerve stimulation (TENS) are not fully understood. Several theories underlying its~     use as a neuromodulator of pain. The gate control theory has led to the development of TENS~     devices. Recruitment of myelinated, large caliber, by the TENS electrodes afferent fibers~     increases the control exerted on spinal level, thereby inhibiting the action of afferent~     fibers of small caliber related to nociception. This stimulation strengthens the blocking of~     gate at the corresponding cell bodies of spinothalamic tract and reduces the transmission~     of nociceptive impulses to the spinal cord dorsal horn. This is segmental presynaptic~     inhibition depends on the area and stimulated.~      The objective of this study is to improve the quality of life through improved sensitivity~     disorders of the hand in patients with MS, thanks to reeducation of the hand.~   "
129916|NCT01866865|"~     Background:~      - Women who have a BRCA1/2 gene mutation have a very high risk of developing breast or~     ovarian cancer. They are also at increased risk of other developing other cancers. Male~     carriers are at increased risk for breast, prostate and other cancers. Testing for this~     mutation and living with this increased risk can be a source of stress for both people with~     the mutation and their partners. Researchers want to look at how well people adapt to living~     with this type of cancer risk over time.~      Objectives:~      - To see how women with the BRCA1/2 gene mutation and their partners adapt to the stress of~     long-term cancer risk.~      Eligibility:~      - Women at least 18 years of age who have a BRCA1/2 mutation, and their male or female~     partners.~      Design:~        -  This study involves a one-time self-administered questionnaire. Participants will be~          recruited from local and national hereditary cancer support groups and cancer centers.~        -  There are two versions of the survey. One is for the woman with the BRCA1/2 gene~          mutation. The other is for her partner.~        -  The survey will ask about risk perception, cancer worry, risk-related stress, and coping~          and adaptation methods.~        -  Treatment will not be provided as part of this study.~   "
129917|NCT01866852|"~     Background:~      - An earlier study on child development focused on the relationship between children and~     their caregivers (usually mothers). It looked at how this relationship influenced children's~     social and mental development. It also studied how these children related with family members~     and friends. Researchers are now interested in expanding the study with the same group of~     children. They want to look at these children, who are now young adults, and focus on their~     current romantic relationships. This new study will look at how child development affects the~     formation of stable, mature romantic relationships in young adulthood. Original child study~     participants and their significant others will be included in the new study. Only~     participants who are living together with a partner will be studied.~      Objectives:~      - To look at romantic partnerships in a childhood study s original participants and their~     significant others.~      Eligibility:~        -  Participants of the 88-CH-32 study who are at least 18 years of age.~        -  Significant others of the study participants who are at least 18 years of age.~        -  Original participants and significant others must be cohabiting (living together).~      Design:~        -  No screening tests will be required for this study. No study visits will be needed.~          Samples will not be collected.~        -  Original study participants will fill out four online questionnaires. They will be on a~          National Institute of Child Health and Human Development (NICHHD) website. They will ask~          personal questions about relationships with the current romantic partner and other~          important people. The questions will take about 25 minutes to answer.~        -  Significant others will fill out 13 online questionnaires. They will be on a NICHHD~          website. They will ask personal questions about the romantic partner and other important~          people. The questions will take about 1.5 hours to answer.~        -  All participants will receive a small amount of money for completing the study.~   "
129918|NCT01866839|"~     Background:~      - Researchers are working to make stem cell transplant procedures safer and more effective.~     One complication of transplants is graft-versus-host disease (GVHD). This complication~     happens when certain white blood cells from the donor attack the recipient's own body.~     Researchers want to test a blood separator machine that may help remove more of the donor's~     white blood cells before transplant. They will study donors and recipients during stem cell~     transplant to see how well this process can prevent GVHD and other complications.~      Objectives:~      - To see if a new blood separator machine can improve outcomes of stem cell transplants.~      Eligibility:~        -  Individuals between 10 and 75 years of age who are having a stem cell transplant for~          leukemia or other blood-related cancers.~        -  Donors for the stem cell transplant.~      Design:~        -  Recipients and donors will be screened with a physical exam and medical history.~        -  Donors will have two blood collection procedures. The first will collect only white~          blood cells, and return the rest of the blood. After the first collection, participants~          will have filgrastim injections to help their stem cells enter their blood. Then, they~          will have a second blood collection for the stem cells.~        -  Recipients will have radiation and chemotherapy to prepare for the stem cell transplant.~          They will then have the stem cell transplant with the donor cells that have been treated~          with the blood separator machine.~        -  Recipients will be monitored closely after the procedure. They may receive some of their~          donor's white blood cells if needed to fight serious infections.~        -  Recipients will have the regular standard of care after their transplant. Blood samples~          will be taken and any side effects will be monitored and treated.~   "
129938|NCT01866579|"~     Ethambutol is widely used as first-line drug, but has serious side effect of optic~     neuropathy. As previously reported, incidence of ethambutol optic neuropathy is about 1~2%,~     there was considerable screening efforts and medical cost is increasing. However, there is no~     effective treatment of ethambutol optic neuropathy or no definite preventable measure.~     Moreover, multi-drug resistance tuberculosis or extensively drug resistance tuberculosis is~     emerging, more toxic secondary drug is used in the long-term.~      It is known that retinal nerve fiber layer is increased early stage in ethambutol optic~     neuropathy. So we decide to evaluate the retinal nerve fiber layer thickness measured by~     optical coherence tomography in longitudinal manner.~   "
129939|NCT01866566|"~     Through evaluating the immunogenicity and safety for Varicella vaccine two doses immune~     procedure we could supply scientific and practical evidence for this two doses immune~     procedure promotion and management.~   "
129919|NCT01866826|"~     Background:~        -  Human immunodeficiency virus (HIV) treatment can control the amount of virus in the~          blood, but it does not provide a cure. The reasons why HIV treatment does not cure the~          infection are not well understood. HIV persists in blood cells for years, even if people~          receive treatment for it. In addition, HIV infection leads to an activated immune~          system, which can cause other problems.~        -  One theory for why HIV infection causes immune activation involves the intestinal tract.~          HIV infects immune cells the intestine soon after infection and damages their immune~          barrier. This damage lets bacteria cross into the bloodstream, leading to ongoing~          inflammation. Even when a person with HIV feels well, this chronic inflammation may~          affect the immune system. Researchers want to see if the antibiotic Rifaximin can reduce~          this inflammation. Rifaximin is designed to stay inside the digestive system, so it~          affects only bacteria in the intestines.~      Objectives:~      - To see if Rifaximin can reduce bacteria-related inflammation in people with HIV.~      Eligibility:~      - Individuals at least 18 years of age who have HIV infection and are taking medications to~     treat it.~      Design:~        -  Participants will be screened with a physical exam, blood test, and medical history.~        -  Participants will take either Rifaximin or a placebo for 4 weeks. They will have no~          medication for 4 to 6 weeks, and then take the other drug for 4 more weeks.~        -  During the study, participants will have frequent blood and urine tests. They will also~          provide stool samples. Liver and kidney function tests will be performed. HIV viral load~          (the amount of virus in the blood) will also be studied.~        -  Participants will have a final follow-up visit after an additional 4 weeks.~        -  Two additional tests are optional for study participants:~        -  Two blood draws: one on the third day after starting Rifaximin, and one on the third day~          after starting the placebo.~        -  Up to three colonoscopies of the lower intestine and biopsies of the intestine. These~          studies will collect samples of the intestinal tract to look at the effects of Rifaximin~          in the study.~   "
129920|NCT01866813|"~     The aim of the proposed study is to investigate whether women treated for breast cancer who~     experience cognitive difficulties will profit from the Internet-based program Scientific~     Brain Training Pro with respect to: 1) attention, working memory, learning and recall, and~     executive function as assessed by standardized neuropsychological tests and 2,) self-reported~     cognitive difficulties in daily life as measured by questionnaires.~   "
129921|NCT01866800|"~     Evaluating whether forced diuresis with matched hydration will reduce the risk of contrast~     induced nephropathy in patients undergoing Transcatheter Aortic Valve Implantation (TAVI).~   "
129922|NCT01866787|"~     The purpose of this observational study is to evaluate the baroreceptor function in relation~     to surgical inflammation and orthostatic intolerance after elective hip arthroplasty.~      The main hypothesis is that baroreceptor function is attenuated after surgery and related to~     surgical inflammation.~   "
129923|NCT01866774|"~     Triaging new pediatric gastroenterology consultations is challenging as both inflammatory and~     non-inflammatory gastrointestinal (GI) diseases can present with non-specific chronic~     abdominal pain and/or diarrhea. Examples of inflammatory GI diseases include Crohn's disease,~     ulcerative colitis and celiac disease and non-inflammatory GI diseases lactose intolerance,~     irritable bowel syndrome and non-ulcer dyspepsia. Inflammatory GI diseases require different~     investigations and treatment than non-inflammatory GI diseases and ideally, would be~     identified early. Higher priority triage of these patients would allow timely organization of~     further investigations including pertinent laboratory testing, radiologic studies and~     gastrointestinal endoscopies. These more invasive procedures are not needed in most patients~     presenting with non-specific gastrointestinal symptoms. Therefore, the investigators do not~     routinely ask for screening laboratory testing or other studies in children referred to our~     clinic.~      Non-invasive screening tests for GI disorders may aid in appropriately triaging new~     consultations to pediatric gastroenterology. Calprotectin is a protein found in inflammatory~     cells called neutrophils. The concentration of calprotectin in stool reflects the presence of~     an inflammatory process occurring in the GI tract. Thus, testing for calprotectin has been~     proposed as a potentially useful test for detecting some inflammatory GI diseases, most~     notably Crohn's disease and ulcerative colitis. Alternatively, a simple gastrointestinal~     questionnaire of red flag symptoms and family history of GI disorders may also be of~     benefit. The investigators hypothesize that the use of fecal calprotectin and a screening GI~     questionnaire will aid in identifying children at higher risk of an inflammatory GI disorder.~     Subsequently, higher priority triaging of these patients will decrease the time to diagnosis~     of inflammatory GI disease.~      This will be a single centre, stratified, randomized clinical trial conducted in Kingston,~     Ontario, Canada. Patients referred to the pediatric gastroenterology service without a known~     diagnosis for non-specific chronic abdominal pain and/or diarrhea will be asked to~     participate in the study. All patients who meet the inclusion criteria will be consented by~     telephone with a standard form. Consenting patients will be mailed the GI questionnaire and~     the fecal calprotectin test kit. The fecal calprotectin test kid includes instructions, a~     stool collection kit and return postage. All patients will be given the next available~     appointment with a pediatric gastroenterologist. Patients will then be randomized to receive~     either usual care (50%, 40 patients) or to have a screening fecal calprotectin (FC)~     measurement (50%, 40 patients). Patients in the FC group will have FC measured by the Quantum~     Blue® Rapid Calprotectin Assay. If the calprotectin level is high (above 50 μg/g), the~     patient will be contacted again by telephone and given a new appointment time (within 14~     working days). This study may have a positive impact by demonstrating a novel method for~     decreasing the time to diagnosis of inflammatory GI disease.~   "
129924|NCT01866761|"~     Objective: We aimed at analyzing the relationship between periodontal disease and~     atherosclerosis in medical treatment and periodontal treatment under medical and dental care~     across borders in a local cooperation system of Japanese medical services.~      Materials and methods:~        -  A prospective multi-center case cohort study was conducted on 37 ambulatory medical~          patients (with lifestyle-related diseases under consultation in either of the medical~          clinics registered as collaborative investigation facilities) and 79 periodontal~          patients (who were seen by the dental clinics registered as collaborative investigation~          facilities).~        -  Medical treatment and clinical periodontal treatment were provided on the subjects under~          medical and dental care across borders by each internal medicine and dental clinics.~        -  Systemic examination of lifestyle-related disease and periodontal examination were~          performed before and after periodontal treatment, and the relationships between~          periodontal and atherosclerosis-related clinical markers were analyzed before and after~          periodontal treatment.~   "
129925|NCT01866748|"~     This trial is conducted in Europe. The aim of the trial is to investigate the safety,~     tolerability and pharmacokinetics (the effect of the investigated drug on the body) of single~     and multiple doses of a long-acting GLP-1 analogue (semaglutide) in an oral formulation in~     healthy male subjects.~   "
129926|NCT01866735|"~     This study will demonstrate that Standardized Rehabilitation Therapy for burn patients with~     ARF reduces hospital stay through immediate improvement in functional capacity and functional~     performance. Our team comprises Burn Surgeons, Intensivists with expertise in Critical Care~     Trial design, Exercise Physiologists and Outpatient Functional Outcome Assessment Experts.~     The design was conceived through the US-Critical Illness and Injury Trials Group which~     allowed these investigators to bring varied expertise to the problems faced by critically ill~     Burn patients.~      Hypotheses:1) Standardized Rehabilitation Therapy (SRT) will shorten hospital stay in burn~     patients with ARF. 2) SRT will prevent loss in muscle size and loss of architecture during~     critical illness of severe burns. 3) SRT will improve objective functional measures and~     quality of life at 3, 6, 12, 24, and 36 months post-enrollment.~   "
129940|NCT01866553|"~     The purpose of this trial is to assess the effect of switching CML patients, who have been~     treated with imatinib ≥ 2 years and who have stable detectable molecular residual disease~     between 0.01-1.0% (IS), to the combination of Nilotinib and PegIFN, in terms of the~     proportion of patients who achieve confirmed MR4.0.~   "
130156|NCT01863732|"~     This 3-year extension study aims at making available the treatment with secukinumab in~     prefilled syringes (PFS) to patients with ankylosing spondylitis who took part in phase III~     study CAIN457F2305, defined as core study, as well as to generate additional data on the~     sustainability of clinical benefits, safety and tolerability during long-term administration~     of secukinumab.~   "
129927|NCT01866722|"~     In our communications with the public, the investigators will call this the Not Quite Ready~     to Quit Smoking Study.~      One new method to increase quit attempts is to have smokers reduce their cigs/day. The~     investigators and others have shown that reduction aided by nicotine medications can increase~     quit attempts and later abstinence among smokers not ready to quit. Because half of smokers~     are reluctant to use nicotine medications for a non-cessation reason, the investigators now~     propose to test whether reduction not aided by nicotine medications can be effective. Another~     new method to increase quit attempts is motivational counseling. The investigators previously~     found implementation of the brief United States Public Health Service (USPHS) Guidelines 5 Rs~     motivational intervention via three 15 min phone calls can provide a large increase in~     quitting (OR = 6.3); however, the investigators need to replicate that result. A vendor will~     proactively email adult, daily smokers listed in a consumer panel to recruit 560 smokers who~     do not plan to quit in the next month and randomize them to a) reduction counseling without~     the aid of nicotine medications , b) brief counseling guided by the USPHS 5 R's, or c) usual~     care. The first two conditions will be delivered via brief counseling calls at study onset~     and then 2 and 4 weeks later (total = 35 min). The usual care condition will consist of a~     brief (< 5 min) phone intervention followed by a quit guide. Our major hypothesis is that the~     incidence of quit attempts over the 6 months of the study will be greater in both the~     reduction and the motivational conditions than in the usual care condition. A secondary~     hypothesis is that the increase in quit attempts will lead to increased abstinence. Another~     secondary hypothesis is that beneficial effects of both treatments will be mediated by~     increases in self-efficacy and intentions to quit. A final hypothesis is that decreases in~     cigs/day and nicotine dependence will mediate the efficacy of the reduction treatment but not~     the motivational treatment and, conversely, that a shift in decisional balance will mediate~     the efficacy of the motivational treatment but not of the reduction treatment.~   "
129928|NCT01866709|"~     It is hypothesized that SPS is more effective than placebo control (alternative hypothesis)~     in lowering i-STAT potassium levels in subjects with i-STAT potassium levels between 5.0 -~     6.5 mmol/l versus no difference between SPS and placebo control (null hypothesis).~   "
129929|NCT01866696|"~     Purpose: The aim of this study was to analyze the clinical and radiographic outcomes of 23~     edentulous jaws treated with 3D software planning, guided surgery, immediate loading and~     restored with Cad-Cam Zirconia and titanium full arch frameworks.~      Material & methods: This study was designed as a prospective clinical trial. Twenty patients~     have been consecutively rehabilitated with an immediately loaded implant supported fixed full~     prosthesis. A total of 120 fixtures supporting 23 bridges (8 mandible, 15 maxilla) were~     placed , 22 of which in fresh post extraction sockets. All the implants were inserted with an~     insertion torque of 35/45 Ncm. 117 out of 120 implants were immediately loaded the other 3~     were delayed loaded.~      Outcome measures were implants survival, radiographic marginal bone-levels and bone~     remodeling, soft tissue parameters and complications.~   "
129930|NCT01866683|"~     Since yoga breathing exercises are traditionally used to tranquilize the mind, and have a~     well-known positive effect on the cardiovascular system, it is our hypothesis that a~     respiratory yoga exercise named bhastrika pranayama may have positive effects on heart rate~     variability, electroencephalography, quality of life and salivary cortisol (stress hormone).~   "
129931|NCT01866670|"~     Condition: patients with breast cancer. Intervention: spiritual support (relaxation + image~     guided + meditation) or relaxation in three consecutive meetings (day 2, 3 and 4), three days~     of intervention in the same week. The first day the participants will be evaluated if she~     meets the needs of the research and will answer questions about their indentification and~     spirituality.~      Type of study: intervention Study design: randomized controlled trial Masking: blind study.~     Randomization: sequence generated by SPSS (Statistical Package for the Social Sciences)~     version 15, organized in sealed envelopes by another qualified professional.~      The research ends in 2014 jun.~   "
129932|NCT01866657|"~     This is a prospective, randomized controlled pilot study of cerebral oximetry use in elderly~     patients undergoing thoracic surgical procedures that require the use of single lung~     ventilation. The hypothesis is that subjects randomized to open cerebral oximetry monitoring~     that have active intervention to mitigate observed desaturations will have measurable~     postoperative clinical outcome benefits when compared to the patients randomized to blinded~     cerebral oximetry monitoring with no active interventions to mitigate desaturations.~   "
129933|NCT01866644|"~     Evaluate the effectiveness of the administration produced antioxidant N-acetylcysteine (NAC),~     decreasing the incidence of primary graft dysfunction and primary failure. The degree of~     dysfunction will be monitored by the method of LIMON, metabonomics techniques and according~     to the latest published validation Liver Transplantation (16 943-949 2010), total~     billirrubina greater than 10 mg / dl, INR greater than 1.6 in the seventh postoperative day~     and alanine or aspartate aminotransferase greater than 2000 IU / L in the first seven days.~     Liver dysfunction is considered, the presence of a transaminase value> 2000 IU / L 1-7~     postoperative day or BT> 10 mg / dl or INR> 1.6, both only in the 7th postoperative day~     (Olthoff et al Liver Transplantation 16,943 -949 2010).~   "
129934|NCT01866631|"~     The investigators hypothesise that the research data will enable them to elucidate local~     clinical practices with regard to breast cancer care and enable them to extrpolate the data~     to improved local clinical care for their patients through self-regulation and audit.~   "
129935|NCT01866618|"~     Natural IVF study patients will undergo an IVF cycle with trigger shots of Lupron & hCG.~     Patients will not be given any other stimulating medications during the cycle. They will have~     2 uterine aspirations and an endometrial biopsy at designated times. The first uterine~     aspiration will be randomized to one of four days (day before retrieval, day of retrieval,~     day after retrieval or 2 days after retrieval). The second uterine aspiration and endometrial~     biopsy will be performed 6 days after retrieval. Any embryo(s) obtained will be biopsied for~     Comprehensive Chromosome Screening (CCS) and frozen for use in a subsequent thaw cycle.~   "
129936|NCT01866605|"~     Patients are often anxious immediately before surgery. The investigators hypothesis is that a~     warming blanket is as effective as the sedative midazolam in allaying anxiety before surgery.~   "
129937|NCT01866592|"~     VIP-E is a one-arm, open-label, 40-52 week extension study to continue or cross over subjects~     of the VIP study (# 814278) to active drug (adalimumab) to determine if there is sustained~     improvement in vascular inflammation, lipid metabolism, and inflammatory markers. VIP-E~     extends VIP study procedures for 40-52 weeks including questionnaires, physical exams, blood~     and urine samples, lab tests, one additional FDG-PET/CT scan, and adalimumab injections~     following FDA-approved psoriasis treatment regimen.~   "
129982|NCT01866007|"~     The purpose of this study is to evaluate the pharmacokinetic (what the body does to the~     medication) comparability of guselkumab in lyophilized and liquid formulations. Also to~     evaluate pharmacokinetic comparability of liquid formulation of guselkumab when delivered as~     prefilled syringe with UltraSafe Passive Delivery System [PFS-U] or with a prefilled syringe~     facilitated injection device [PFS FID]) following a single subcutaneous (SC) administration~     of 100 mg guselkumab in healthy participants.~   "
129941|NCT01866540|"~     This research during the last decade has focused on the kinetics of the systemic and local~     immune response to parenteral influenza vaccine in humans. The investigators have shown that~     normally high numbers of influenza specific antibody secreting cells (ASC) are present in the~     nasal mucosa of healthy adults but upon parenteral vaccination the numbers remain stable.~     However, a rapid transient increase in specific ASC is observed in the tonsils and peripheral~     blood after parenteral vaccination. In the tonsils, this is associated with a significant~     decrease in both naïve/effector (CD45RA+) and memory (CD45RO+) CD4+ cells upon vaccination.~     In this study the investigators will extend our work to investigate the characteristics of~     influenza-specific T- and B-cells induced locally and systemically after intranasal~     vaccination in man.~   "
129942|NCT01866527|"~     Early treatment is considered essential for developmental dysplasia of the hip (DDH), but the~     choice of screening strategy is debated. The investigators evaluated the effect of a~     selective ultrasound (US) screening programme.~      All infants born in a defined region during 1991-2006 with increased risk of DDH, i.e.~     clinical hip instability, breech presentation, congenital foot deformities or a family~     history of DDH, were subjected to US screening at age one to three days. Severe sonographic~     dysplasia and/or dislocatable/dislocated hips were treated with abduction splints. Mild~     dysplasia and/or pathological instability, i.e. not dislocatable/dislocated hips were~     followed clinically and sonographically until spontaneous resolution, or until treatment~     became necessary. The minimum observation period was 5,5 years.~   "
129943|NCT01866514|"~     This will be a prospective, non-controlled study using healthy adult volunteers as subjects~     receiving bilateral proximal humerus intraosseous (IO) vascular access to evaluate the~     insertion technique and IO infusion flow rates.~   "
129944|NCT01866501|"~     A Follow-up Study Validating a Blended Technique for Identifying the Proximal Humerus~     Intraosseous Vascular Access Insertion Site~   "
129945|NCT01866488|"~     The current study is a randomized, controlled, double-blinded trial of Obstetric Cook~     Catheter combined with oral misoprostol for induction of labor in pregnant patients. The~     primary outcome to be studied is vaginal delivery rate for the Obstetric Cook Catheter in~     combination with oral placebo and the Obstetric Cook Catheter in combination with oral~     misoprostol. Secondary outcomes to be studied include the safety of the method, composite~     maternal morbidity and composite neonatal morbidity.~      The hypothesis is that there is a higher vaginal delivery rate in the patient whom receive~     both the Obstetric Cook Catheter and the oral misoprostol.~   "
129946|NCT01866475|"~     A prospective study to determine the safety of intraosseous (IO) access for a period up to 48~     hours in healthy adult volunteers and volunteers with a history of mild to moderate renal~     disease and/or controlled diabetes.~   "
129947|NCT01866462|"~     The purpose of the study is to determine if NM504 will prevent GI side effects that are~     associated with using metformin for the treatment of diabetes.~   "
129948|NCT01866449|"~     The proposed study is an open-label, single-arm, Phase- II trial to assess the efficacy of~     cabazitaxel in GBM WHO grade IV patients with a progression during or within 6 months after~     last temozolomide treatment (Figure 1).~      Cabazitaxel will be given at a dose of 25mg/m² as 1h infusion every 3 weeks with standard~     concomitant medication (as outlined below):~        -  On Day 1 of each cycle, patients will receive cabazitaxel at a dose of 25mg/m²,~          administered by i.v. route in 1 hour.~        -  Cycle length for cabazitaxel is 3 weeks (21 days).~        -  New cycles of therapy may not begin until Absolute Neutrophil Count (ANC) ≥1500/mm3,~          platelet count ≥75 000/mm3, and non-hematological toxicities (except alopecia) have~          recovered to baseline.~        -  A maximum of 2 weeks (14 days) delay is allowed between 2 treatment cycles.~        -  Patients should come off treatment if treatment delay is more than 2 weeks.~      At least 30 minutes prior to each administration of cabazitaxel, patients will receive i.v.~     premedication including:~        -  An antihistamine (dexchlorpheniramine 5mg, diphenhydramine 25mg, or equivalent). In case~          of i.v. antihistamine other than promethazine is not being available, local practice~          should be followed.~        -  Corticosteroid (dexamethasone 8mg or equivalent)~        -  H2 antagonist (ranitidine or equivalent).~        -  Antiemetic prophylaxis is recommended and can be given orally or intravenously if~          necessary.~        -  Primary prophylaxis with Granulocyte Colony-Stimulating Factor (G-CSF) should be given~          on day 4 of each treatment cycle as per ASCO and ESMO guidelines.~   "
129949|NCT01866436|"~     To practice independently surgeons require competency in surgical skills, encompassing a~     combination of technical and non-technical skills. Cognitive skills, aspects of non-technical~     skills, represent an integral component of surgical competency. Cognitive skills comprise~     factual knowledge and decision-making.~      Changing work patterns in the United Kingdom, as specified by the European Working Time~     Directive (EWTD), have had a profound impact on the delivery of surgical skills training.~     Surgical trainees are now increasingly removed from normal working hours in which the~     majority of traditional operative training and experience is gained, leading to a net~     reduction in trainees' operative exposure. This reduction in operative experience means that~     surgical competence can no longer be assured on the basis of experience alone.~      Although there is no educational technology that can replace the craft apprenticeship~     required to train a competent surgeon, reduction in training hours has led to rapid~     development of educational tools to augment surgical skills training outside the operating~     room environment. These tools tend to concentrate on technical skills performance without~     emphasis on cognitive skills.~      Trainees in today's era have grown up in a multimedia environment; multimedia is media that~     uses a combination of text, voiceover, animation and video. Multimedia is an underdeveloped~     educational resource that can supplement cognitive skills training in operative surgery.~      The purpose of this study was to design and develop an online multimedia educational tool in~     a common colorectal surgery procedure (Anterior Resection) and determine the effectiveness~     of this tool in teaching and assessment of cognitive skills.~      Study hypothesis: Multimedia learning is equivalent to conventional teaching Study Day in~     improving scores in cognitive surgical skills.~   "
129950|NCT01866423|"~     This phase II trial studies how well orteronel works in treating patients with metastatic~     hormone-resistant prostate cancer. Orteronel may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth.~   "
129951|NCT01866410|"~     This phase II trial studies how well cabozantinib-s-malate and erlotinib hydrochloride works~     in treating patients with previously treated metastatic non-small cell lung cancer.~     Cabozantinib-s-malate and erlotinib hydrochloride may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Cabozantinib-s-malate may also stop the~     growth of non-small cell lung cancer by blocking blood flow to the tumor. Giving~     cabozantinib-s-malate together with erlotinib hydrochloride may be an effective treatment for~     non-small cell lung cancer.~   "
132192|NCT01837056|"~     Investigate the prevalence of Toxoplasma gondii and Toxocara canis in Uveitis~        -  serum antibody to T. gondii and T. canis~        -  PCR with peripheral blood for T. gondii and T. canis~        -  PCR with aqueous humor for T. gondii and T. canis~        -  Clinical manifestation of patient with uveitis~   "
129952|NCT01866397|"~     Cidofovir is an acyclic nucleotide analog with broad-spectrum antiviral activity against~     herpesviruses. Its potency in inhibiting HCMV has been shown in conventional in vitro~     studies. It is approved for the systemic treatment of human cytomegalovirus (HCMV) retinitis~     in patients with AIDS and as a second line therapy for HCMV infections not responding to~     ganciclovir or foscarnet.~      In intensive care patients continuous venovenous haemofiltration (CVVH) is a well-established~     extracorporal renal replacement therapy with a high clearance rate.~      Pharmacokinetic studies of antifungal agents in critically ill patients treated with CVVH are~     rare. Elimination of any given drug by renal replacement therapy is determined by several~     major factors which are membrane specific, due to physico-chemical properties of the drug and~     characteristics of the renal replacement technique used.~      Study objective The trial is conducted to investigate the pharmacokinetics of cidofovir~     during CVVH in critically ill patients. It is suspected that Hemofiltration will influence~     cidofovir plasma levels.~   "
129953|NCT01866384|"~     Early hematoma growth (HG) after spontaneous intra-cerebral/intra-parenchymal hemorrhage~     (IPH) is common and associated with neurological deterioration and poor clinical outcome.~     Temperature modulation to hypothermia (Temperature, 32-34°C) has been associated with~     reduction or improvement of physiopathologic processes associated with inflammatory~     activation and degradation of blood-brain barrier after all types of brain injury. In this~     sense, we believe that the initiation of an ultra-early protocol of active temperature~     modulation or Targeted Temperature Management (TTM) to mild induced hypothermia (MIH,~     32-34°C) may be associated with good safety and tolerability profile, less HG and cerebral~     edema after IPH by modulation of systemic and local inflammatory responses, so we hypothesize~     that TTM to MIH will be a safe/tolerable and effective therapy to limit HG and cerebral edema~     after IPH.~   "
129954|NCT01866371|"~     Studying the morphology and function of the normal and diseased retina in vivo is needed for~     advancing the detection, diagnosis, and treatment of retinal disease. This protocol uses an~     adaptive optics scanning laser ophthalmoscope (AOSLO) to image the normal and diseased retina~     with individual cellular resolution non-invasively. The primary objective of this study is to~     obtain and analyze high-resolution images of the retina, in particular by imaging the cone~     photoreceptor mosaic, the retinal vasculature and other retinal layers. The study design will~     involve case-control studies, where cases are followed over time. Subjects age 7 and older~     may be invited to participate. The main research procedure involves retinal imaging with the~     AOSLO. The primary endpoint is the observation of differences in retinal images between~     subjects with and without retinal diseases. These changes will be quantified by examining the~     cell density, size, spacing and regularity of the cone photoreceptor mosaic, as well as~     examining the differences between other retinal layers.~   "
129955|NCT01866358|"~     Intraosseous infusion is better than umbilical vein infusion for neonatal asphyxiated~     resuscitation~   "
129956|NCT01866345|"~     The purpose of this investigation is intended to evaluate the efficacy of surgically~     facilitated orthodontic treatment (SFO) in terms of treatment time, incidence of root~     shortening, and occurrence of mucogingival side effects compared to conventional orthodontic~     therapy in patients undergoing orthodontic treatment to correct crowding and/or~     retroclination of their mandibular anterior dentition.~   "
129957|NCT01866332|"~     The purpose of this study is to determine the effectiveness of the addition of the use of~     Kinesio Taping in patients with chronic nonspecific low back pain who receive conventional~     physical therapy.~   "
129958|NCT01866319|"~     This study will evaluate the safety and efficacy of 2 different dosing schedules of~     pembrolizumab (MK-3475), every 2 weeks (Q2W) and every 3 weeks (Q3W), and compare the 2~     schedules to treatment with ipilimumab in ipilimumab-naïve participants with unresectable or~     metastatic melanoma.~      Participants assigned to treatment with pembrolizumab could receive up to 2 years of~     treatment; if participants stopped treatment at 2 years and later experienced progression,~     they were eligible for a second course of treatment for up to 1 additional year. With~     Amendment 05, all Second Course participants will be treated with a fixed dose of~     pembrolizumab 200 mg Q3W. With Amendment 06, after the study has achieved its key objectives~     or the study has ended, participants will be discontinued from this study and enrolled in an~     extension study to continue protocol-defined assessments and treatment.~   "
129959|NCT01866306|"~     The purpose of this study is to establish the safety and tolerability of Unbiased Biomarkers~     for the Prediction of Respiratory Disease Outcomes (U-BIOPRED) human rhinovirus 16 (RV16UB)~     in healthy and asthmatic participants, and to identify an appropriate dosage of RV16UB in~     order to study biomarkers in asthmatic participants. The study is divided into 2 parts. Part~     1 is a dose-finding study where healthy participants, and asthmatic participants, who were~     either treated or not treated with a class of long-acting beta antagonists (LABA) will be~     recruited to undergo nasal challenge with increasing doses of RV16UB. Part 2 is a biomarker~     study where mild to moderate asthmatics undergo challenge with the most appropriate dose of~     RV16UB identified in Part 1, based on tolerability and viral effects. .~   "
129960|NCT01866293|"~     This study is an open label phase I/II trial to investigate the safety and efficacy of~     Cabozantinib for patients with relapsed or refractory myeloma.~   "
129969|NCT01866176|"~     The purpose of this study is to evaluate the immediate effects of a knee brace with a new~     mechanism on the pain and medial knee loading during gait among medial knee osteoarthritis~     patients. The effects of this new brace is compared to a stabilizing brace and a typical~     valgus knee brace. The investigators recruited 24 knee osteoarthritis and they have to wear~     each of the three braces during three months. A fifteen days wash-out period is given after~     each three months. Biomechanical evaluation is carried out before and after each three~     months. This evaluation consisted of three questionnaires (KOOS, WOMAC and Medical Outcome~     Score Short Form-36 (MOS-SF36)), a motion analysis with an optoelectronic system, then a~     6-min walk test. During motion analysis, ten gait trials are executed without brace and ten~     with the brace.~   "
129970|NCT01866163|"~     The purpose of this trial is to compare the efficacy of treatment with LEO 90100 to that of~     treatment with vehicle for up to 4 weeks in subjects with psoriasis vulgaris.~   "
130960|NCT01853189|"~     Asthma is a highly prevalent chronic disease in children. Complementary and Alternative~     Medicine research on asthma showed a potential effect on pediatric patients.~      Studies looking at the effect of Osteopathic Manipulative Treatment seems to reveal positive~     results.~      The aim of study is to further explore the role of OMT on asthma in a pediatric population.~   "
129961|NCT01866280|"~     The purpose of this study is to test the effects of sleep and meal timing, independent of~     sleep duration, on glucose regulation and metabolic and hormonal control of energy balance in~     normal weight adults.~      This study will be a 4-phase, randomized controlled study of 5 days each in which~     participants will undergo 2 phases of late sleep times that differ in meal timing (normal or~     late) and 2 phases of normal sleep times that differ in meal timing (normal or late).~      The Aims and Hypotheses of this study are:~      Aim 1: To compare hormonal regulation of food intake and metabolic risk markers in response~     to altered sleep and meal timing.~        -  Hypothesis 1: There will be an interaction between sleep and meal time on glucose,~          insulin, and glucose and insulin area under the curve after the glucose tolerance test~          such that the late sleep/late meal will result in the worst metabolic profile, normal~          sleep/late meal and late sleep/normal meal will have an intermediate profile, and normal~          sleep/normal meal will result in the best metabolic profile.~        -  Hypothesis 2: There will be an interaction between sleep and meal time on leptin and~          ghrelin concentrations such that the late sleep/late meal timing phase will result in~          low leptin/high ghrelin, normal sleep/late meal timing and late sleep/normal meal will~          have an intermediate profile, and normal sleep/normal meal timing will result in high~          leptin/low ghrelin.~      Aim 2: To compare food intake over a 24-h period in response to altered sleep and meal~     timing.~      • Hypothesis 3: Energy and fat intakes will be greater during the late sleep timing phase~     compared to normal sleep timing.~   "
129962|NCT01866267|"~     This pilot single arm, single site, open-labeled switch study seeks to enroll thirty (30) HIV~     positive patients infected with CCR5 tropic virus that have achieved an undetectable viral~     load on a non-Selzentry®-containing regimen [Protease Inhibitor (PI)/Non-Nucleoside Reverse~     Transcriptase Inhibitor (NNRTI)/Integrase Inhibitor plus 2 Nucleoside Reverse Transcriptase~     Inhibitor (NRTI)] and switch them to once-daily Selzentry® (600mg qd) plus the same 2 NRTIs.~   "
129963|NCT01866254|"~     The purpose of this study is to determine if intrathecal hydromorphone will relieve pain as~     well as intrathecal morphine after cesarean delivery, with fewer side effects.~   "
129964|NCT01866241|"~     Null hypothesis: 10 IU Oxytocin is better than sublingual misoprostol 600µg in management of~     third stage of labor Alternative hypothesis: Sublingual misoprostol 600µg is non- inferior to~     10 IU oxytocin and will not be more than 6% worse [than 10 IU oxytocin] in management of~     third stage of labor~   "
129965|NCT01866228|"~     The time period from diagnosis through to the end of treatment is challenging for patients.~     Patients need information, assistance with decision making, and emotional and social support~     to help cope with their diagnosis and treatment. The first meeting with the cancer doctor is~     especially anxiety-provoking for patients who will learn, for the first time, their treatment~     options and likelihood of being cured. This anxiety causes many patients to have difficulty~     remembering the important pieces of information that their cancer doctor tells them during~     this consultation. The main goal of this study is to demonstrate the benefits of giving~     cancer patients an audio-recording of their first consultation with their cancer doctor. The~     investigators will include newly diagnosed patients from cancer centres in Winnipeg and~     Calgary. The types of cancer that will be included in this study are brain and~     neuroendocrine. Patients with these types of cancer are more likely to have confused~     thinking, and therefore may have the most to gain from receiving their consultation~     recordings. The study will include 244 patients, and those who sign consent forms to~     participate will be assigned by chance to either receive their treatment consultation~     recording or not. Patients will receive their recording immediately after their consultation,~     and will be able to listen to the recording at any time either alone, or with family and~     friends. To figure out whether the consultation recording provides patients with benefits,~     the investigators will administer some questionnaires to patients at 1 week after the~     consultation, and again at 3 and 6 months after the consultation. These questionnaires will~     assess the following patient outcomes: i) anxiety and depression, ii) perception of being~     informed about the disease and treatment, iii) satisfaction with cancer care, iv)~     satisfaction with the doctor, and v) the extent to which patients are satisfied with their~     degree of involvement in treatment decision making. The investigators hypothesize that~     patients who receive their consultation recording will experience more benefits than patients~     who do not receive their consultation recording.~   "
129966|NCT01866215|"~     A high fructose diet increases fasting and post-prandial triglyceride (TG) concentrations in~     sedentary healthy human subjects.These effects may be secondary to fructose-induced hepatic~     de novo lipogenesis. Recent evidence indicate that exercise can prevent fructose induced~     dyslipidemia.This study will evaluate~        1. how exercise effects the metabolic fate of oral fructose 1a) when exercise is performed~          before fructose ingestion 1b) when exercise is performed after fructose ingestion~          Metabolic effects of exercise will be assessed in healthy male subjects by measuring~          fructose oxidation (13CO2 production), fructose conversion into glucose (13C glucose~          concentrations in blood) and hepatic fructose conversion into lipid (13C palmitate-very~          low density lipoprotein (VLDL) concentrations in blood) after ingestion of 13C-labelled~          fructose meals~        2. how fructose and protein modulate muscle glycogen and intramyocellular lipid repletion~          after exercise Healthy male subjects will be fed various fructose, glucose, lipid and~          whey protein meals after a glycogen/intramyocellular lipid depleting exercise. The~          effects of meals' composition will be assessed after 24 hours by measuring~          intramyocellular lipids and glycogen using proton-magnetic resonance spectroscopy (MRS).~   "
129967|NCT01866202|"~     Aims: To evaluate the role of monoclonal antibodies in the detection of cancer specific~     antigens in blood and tumor tissue, and the potential use of these antibodies for future~     evaluation for therapy. Also, to evaluate the presence of circulating tumor cells (CTCs) and~     to study EMT (epithelial-mesenchymal) signature changes during chemotherapy.~      Methods: To take 20mls of blood from advanced breast cancer patients before a new course of~     anti-cancer therapy, and another 20mls of blood 3 weeks after treatment. In addition, Consent~     will be obtained to cut 10-15 tissue sections from their archival tumor specimens. Whenever~     possible, the blood taking will be timed such that no additional needle prick will be done~     specifically for the purpose of the study, by coinciding it with standard blood taking which~     is required for the patient's treatment.~      Importance of proposed research to science or medicine:Detection of tumor specific antigens~     in the blood may potentially reduce the need for more invasive biopsies for confirmation of~     diagnosis of cancer or follow-up of cancer in the future. The identification and development~     of antibodies specific to these tumor antigens or markers may offer future therapeutic~     options, or as a vehicle to deliver cytotoxic therapy. Identification of CTCs as well as~     understanding the changes that occur in EMT signature in these circulating tumor cells may~     serve as a means of potential means of prognostication and modification of therapy in the~     future.~      Potential Benefits and Risks: Potential risks to the patient include that of blood taking~     (pain, feeling faint, infection). Patients will not benefit directly from the study but the~     knowledge gained may help the management of future patients.~      Cancer biomarkers, such as antigens and circulating tumor cells, may be a potential area to~     developing new methods of diagnosis and treatment of cancer. Monoclonal antibiotics are now~     able to be identified and isolated that may specifically target progenitors of breast cancer~     as well as CTCs. The changes that occur to CTCs during treatment may serve as a means of~     prognostication, as well as allow for therapeutic modifications. Clinical correlative studies~     into these areas (MAbs and CTCs) will serve to determine the role of these in clinical~     application in the future.~   "
129968|NCT01866189|"~     This study is a French multicenter prospective study including 5 stroke units with available~     MRI and F-MISO PET for patients with acute ischemic stroke.~      Background and Purpose: 18F-Fluoromisonidazole (FMISO) PET has been used to identify hypoxic~     tissues in animals and stroke patients. While MRI has become the gold standard acute stroke~     imaging, no published study has compared FMISO PET and MRI.~      The aim of this prospective study is to identify hypoxic tissues in 40 patients with acute~     ischemic stroke with F-MISO PET and to compare the location and the outcome of these hypoxic~     cells with MRI datas (weighted diffusion and FLAIR) and to clinical outcome.~   "
129973|NCT01866124|"~     The MAM'Out research project aims at evaluating a seasonal and multi-annual cash transfer~     program in the framework of a safety net to prevent acute malnutrition by children under 24~     months, in terms of effectiveness and cost-effectiveness in the Tapoa province (East region~     of Burkina Faso, Africa). The program will be targeted to economically vulnerable households~     with children less than 1 year old at the time of inclusion and the cash distributed to~     mothers. The transfers will be assimilated to unconditional ones, leading to beneficiaries'~     self-determination on the use that will be made of cash. This study will be designed as a~     two-arm cluster randomized intervention trial, based on randomization of rural villages of~     the Tapoa province. One arm will receive the intervention and one will be a control arm. The~     main outcomes will be the cumulative incidence of acute malnutrition (or wasting) and the~     cost-effectiveness. Anthropometric measures (height, weight and MUAC) will be measured, as~     well as indicators of dietary diversity, food security, health center frequentation,~     families' expenses and morbidities. Questionnaires and 24-hour food recalls will also be~     analyzed. Finally, based on a model theory framework built a priori, the pathways used by the~     cash to have an effect on the prevention of under-nutrition will be assessed.~   "
129974|NCT01866111|"~     This is a multicenter, double-blind, randomized, placebo-controlled dose response study, with~     an 8-week prospective baseline and an 18 week double-blind treatment period (including a~     6-week titration phase and 12 week maintenance phase), followed by a 3-week blinded study~     drug taper period (for subjects leaving the study) or a 2-week blinded conversion period (for~     subjects who will participate in the open-label extension).~      The primary objective of this study is to determine the effective dose range of YKP3089 as~     adjunctive therapy for the treatment of partial seizures.~      The trial will also evaluate the safety and tolerability of YKP3089 in the partial epilepsy~     population.~   "
129975|NCT01866098|"~     This study is designed to look at the effects of naltrexone on weight loss in individuals~     treated with antipsychotic medications. Naltrexone is an FDA approved medication for the~     management of alcohol dependence and drug dependence, but has not been fully evaluated for~     its effect on weight loss in individuals with severe mental illness (i.e. schizophrenia,~     schizoaffective disorder, bipolar disorder etc.) The purpose of this study is to find out how~     effective two different doses of oral naltrexone is on reducing body weight when compared to~     placebo (an inactive substance or sugar pill).~   "
129976|NCT01866085|"~     The study is designed to assess efficacy and subject satisfaction of two sling devices:~     Advance and Argus, in male patients with stress urinary incontinence after prostatectomy.~   "
129977|NCT01866072|"~     Transient elastography is novel non-invasive method for assessment of hepatic fibrosis in~     patients with chronic liver disease, by measuring liver stiffness. Transient elastography is~     a user friendly technique that can be easily performed at bedside or in outpatient clinic~     with immediate results and good reproducibility.~      Liver stiffness values ranges from 2.5 to 75 kPa with lower values <6kPa suggest no fibrosis~     where as higher values above 14kPa suggests cirrhosis. In the present study the investigators~     hypothesis that the investigators can differentiate ACLF and acute severe viral hepatitis~     based on fibroscan as patients with underlying fibrosis with superadded inflammation would~     have higher fibroscan value than when patient have only inflammation with no underlying~     fibrosis and hence the investigators can avoid unnecessary test in such subgroup.~   "
129978|NCT01866059|"~     This study will involve filling teeth which have decay on their roots with three different~     filling materials. Patients will attend Cork University Dental School and hospital for a~     clinical examination and to complete a questionnaire describing how they feel about the~     comfort and appearance of their teeth. Patients will be asked to provide a sample of saliva~     by spitting into a tube. This saliva will be tested to see what levels of bacteria are~     present and how well their saliva neutralises acid in their diet. This is used to assess how~     high or low the patient's risk of dental decay is. They will also complete a questionnaire~     about the amount of sugar in their diet and how often they clean their teeth. If the exam~     shows that any teeth are so decayed that they cannot be filled, the patient will then be~     offered extraction of these teeth. All treatment will be discussed with the patient. Patients~     will be randomly assigned one of the three materials and this material will be used for their~     fillings. Patients will not know which of the three materials they received but all three~     materials are already in use in dentistry and all of the elements of each treatment plan are~     well recognised, routine dental procedures. After all the treatment has been completed, each~     patient will be shown how best to take care of their teeth and how to manage their sugar~     intake to reduce their risk of further decay.~      Patients will be given appointments to return for review at 6 months, 12 months, 18 months~     and 24 months after treatment. This will include a dental examination and dental impressions~     will be taken. These are used to measure how the restorative materials wear over time.~     Patients will also be asked to complete again the two questionnaires that they completed at~     their first visit to see if any of their answers have changed.~   "
129979|NCT01866046|"~     This is a developmental study evaluating a new rapid HIV testing and risk prevention~     intervention for residents of battered women's shelters who endorse risky sexual behaviors.~   "
129980|NCT01866033|"~     The purpose of this study is to assess the absolute bioavailability of oral PCI-32765 and the~     effect of grapefruit juice on the absorption of PCI-32765 in healthy adult participants.~   "
129981|NCT01866020|"~     Invasive pulmonary aspergillosis (IPA) is difficult to diagnose and remains a cause of high~     morbidity and mortality in critically ill patients in the ICU. Accepted diagnostic protocols~     for haemato-oncological patients are not applicable for critically ill patients in ICUs.~     Definitive discrimination between aspergillic colonisation and IPA often depends on the~     clinical experience of the treating physician, evaluating clinical signs, co-morbidities, and~     course of the disease. Life saving treatment with the first line antimycotic Voriconazol~     (Vfend®) can only be initiated after diagnosis of IPA.~      In this prospective clinical trial the investigators aim to structure, optimize and fast~     track the diagnostic pathway of IPA in critically ill patients treated in our ICU-department.~   "
129983|NCT01865994|"~     The purpose of this study is to determine the measuring accuracy of the truly non-invasive~     method estimated continuous cardiac output (esCCO) against the reference method~     transesophageal echocardiography in pediatric cardiac surgery. esCCO is calculated using the~     pulse wave transit time, which is defined as the time between the R-wave of the ECG and the~     30% increase of the differentiated pulseoximetry waveform.~   "
129984|NCT01865981|"~     Hereditary cardiac arrhythmias (genetically caused disturbances of heart rhythm) are life~     threatening conditions affecting otherwise healthy young individuals. Due to the~     inaccessibility of heart tissue, the abnormal electrical current(s) in the heart cells~     causing the rhythm disturbance can be difficult to study in detail and therefore in many~     cases remain untreatable. The investigators propose to study heart cell electrical function~     from such patients by reprogramming skin cells to become stem cells and then differentiating~     them to heart muscle cells.~      The hypothesis of the study is that the differentiated cardiac cells will display electrical~     abnormalities dependent on the mutation causing the disease. These abnormalities can~     therefore provide a clue as to the nature of the mutation causing the disease or information~     about its effective management~   "
129985|NCT01865968|"~     A phase IV, randomization, single center, controlled clinical trial to compare the safety,~     immunogenicity,three-year immune persistence of inactivated hepatitis A vaccine (HAV) with~     one- or two-dose regimen and live attenuated HAV with one-dose regimen in Chinese young~     adults, and to evaluate the immunogenicity of a booster dose.~   "
129986|NCT01865955|"~     Pre-procedural ultrasound for Spinal & Epidural anesthesia is now being increasingly~     performed worldwide. Pre-procedural ultrasound assessment of the spine has been shown to~     facilitate the placement of epidural anesthesia in pregnant women, diagnostic lumbar~     punctures, performance of spinal anesthesia in non-obstetric patients and accurate~     identification of the interspace at which the puncture is being performed. This is especially~     important during spinal anesthesia, where puncture below the ending of the spinal cord is~     recommended for safety.~      The purpose of this study is to compare the performance of spinal anesthesia between the~     pre-procedural ultrasound assessment of the spine and the traditional palpatory technique, in~     term pregnant women undergoing elective cesarean delivery. Furthermore, we aim to describe~     sonoanatomic features of the spine that could predict the ease of insertion of spinal~     anesthesia in that patient population.~      We hypothesize that in term pregnant women undergoing elective cesarean delivery,~     pre-procedural ultrasound assessment of the spine will improve the success rate of spinal~     anesthesia at first attempt, compared to the traditional palpatory technique.~   "
129987|NCT01865942|"~     The investigators wish to evaluate the effect of minimal access spinal surgery compared to~     traditional open surgery spinal surgery in patients with metastatic spinal cord compression.~      Minimal access surgery has been shown to bee less damaging for the tissue compared to~     traditional open surgery and also cause fewer wound complications, the investigators expect~     the above could have impact in a vulnerable patient group like patients with metastatic~     spinal cord compression.~   "
129988|NCT01865929|"~     A randomised controlled trial comparing hysterectomy by minimally invasive surgical methods;~     robotic hysterectomy versus vaginal hysterectomy or traditional laparoscopic hysterectomy;~     outcome and cost analyses.~   "
129989|NCT01865916|"~     This study is a randomized, controlled, single centre, endoscopist-blinded non-inferiority~     trial. The purpose of our study is to determine if using a 2-litre mixture in combination~     with vitamin C is better than using 2 litres of mixture with bisacodyl tablets. Two-litre~     PegLyte based preparations with an added laxative agent are commonly used for colonoscopies~     in outpatient settings. If the investigators discover that a 2-litre mixture with either the~     tablets or the ascorbic acid work better, future patients undergoing colonoscopy will be able~     to experience fewer side effects and be less troubled by the preparation while still allowing~     a good view of the colon.~   "
129990|NCT01865903|"~     Weight loss and loss of lean body mass are common and associated with adverse outcomes such~     as loss of strength, reduced immune- and pulmonary function and increased disability in~     advanced cancer. Progressive weight loss interferes with cancer therapy and is responsible~     for reduced quality of life (QoL) as well as shorter survival irrespective of tumour mass or~     presence of metastases. Weight loss in advanced cancer is regarded as a major clinical~     challenge because of its serious consequences, its varying aetiology and the contribution of~     multiple pathophysiological mechanisms that are poorly disentangled.~   "
129991|NCT01865890|"~     The investigators are trying to find out if Clopidogrel (Plavix) is as effective in~     hemodialysis patients as in patients not hemodialysed.~   "
129992|NCT01865877|"~     The objective of the study is to assess the effect of motor, non-motor and genetic factors on~     the progression of Parkinson's disease as well as its impact on complications rates.~      A large sample of Mexican subjects with Parkinson's disease attending several referral~     centers will be included.~      Data collected will include disease severity and motor scales, non-motor scales as well as~     genotyping for monogenic forms of the disease.~      Assessments will be performed every 6 months for two years.~   "
129993|NCT01865864|"~     to test whether using CPAP can restore the normal pattern of drop of blood pressure during~     sleep.~   "
129994|NCT01865851|"~     Currently used face mask has certain disadvantages; such as, not providing a complete seal in~     certain patients, causing hand fatigue after holding the mask in place for more than a few~     minutes, causing claustrophobia in an occasional patient, the need to hold the mask from head~     of the bed, and possible worsening of the trauma in patients with facial injuries, and the~     need to use different size masks in different patients. The NuMask overcomes all of these~     disadvantages and does benefit the patients.~   "
129995|NCT01865838|"~     The investigators intend to determine the role of Seprafilm, a popular anti-adhesive agent in~     minimising internal adhesion formation in the neck after thyroid surgery and therefore reduce~     swallowing discomfort experienced by patients after surgery.~   "
129996|NCT01865825|"~     The investigators would like to determine if there are patients with PPI responsive~     Eosinophilic Esophagitis Infiltration that have significant loss of esophageal distensibility~     suggestive of esophageal fibrosis typical of classic Eosniophilic Esophagitis.~      If this group of patients exists, the investigators would like to determine if they have the~     typical endoscopic features of EoE rather than those of GERD.~   "
129997|NCT01865812|"~     The purpose of this study is to determine if obeticholic acid (OCA) has an effect on~     cholesterol levels in the blood in patients with PBC.~   "
130037|NCT01865292|"~     This trial is conducted in Europe. The aim of this trial is to compare the pharmacodynamics~     (the effect of the investigated drug on the body) and pharmacokinetics (the exposure of the~     trial drug in the body) of insulin degludec (insulin 454), an explorative formulation, not~     similar to the proposed commercial formulation, with insulin glargine in subjects with type 1~     and type 2 diabetes.~   "
129998|NCT01865799|"~     This is a prospective, 3-year observational study to describe drug utilization in uninfected~     individuals (UIs) who initiate emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)~     (Truvada®) for a pre-exposure prophylaxis (PrEP) indication.~      An electronic source of pharmacy/medical encounter information will be used to assess the~     demographics and other characteristics of the subjects prescribed FTC/TDF or its components~     in a prospective fashion. The data provider will supply all the de-identified information~     regarding each visit/interaction that the subject has had with the health system and all the~     diagnoses and medications that the UI has had prospectively and retrospectively for the~     length of time captured by the source selected.~      200 physicians who prescribe FTC/TDF for a PrEP indication will be sampled from the same~     source.~   "
129999|NCT01865786|"~     This is a prospective, observational study to describe pregnancy outcomes among HIV-1~     uninfected pregnant women who are taking emtricitabine (FTC)/tenofovir disoproxil fumarate~     (TDF) (Truvada®) for a pre-exposure prophylaxis (PrEP) indication nested in the~     Antiretroviral Pregnancy Registry (APR).~      Information on subjects is provided to the APR prospectively (prior to the outcome of the~     pregnancy being known) through their healthcare provider, with follow-up obtained from the~     healthcare provider following determination of the pregnancy outcome.~   "
130000|NCT01865773|"~     A major limitation of standard hemodialysis is that it does not clear the plasma from~     interleukin-6 (IL-6) and p-cresol, two uremic toxins responsible for the high cardiovascular~     risk in end stage renal disease (ESRD). In the present study, we evaluated whether these~     compounds are removed by HFR-Supra, a double-chamber hemodiafiltration system in which the~     ultrafiltrate (UF) returns to the patient after its regeneration through a resin cartridge.~     We selected 8 inflamed chronic hemodialysis (HD) patients, which underwent a single 240~     minutes HFR session. We studied the change in both IL-6 and p-cresol circulating levels, by~     comparing pre- and post-HFR serum concentrations. In addition, we compared Il-6 and p-cresol~     levels in the UF entering (UFin) and exiting (UFout) from the cartridge, either at the start~     or at the end of the HFR session. The proinflammatory activity of UFin and UFout was~     determined by evaluating the changes that they induced in IL-6 messenger ribonucleic acid~     (mRNA) expression and release in peripheral blood mononuclear cells (PBMC) collected from 8~     healthy volunteers and cultured in vitro for 24 hr.~   "
130001|NCT01865760|"~     With increasing rates of obesity the number of anti-obesity operations performed is~     increasing; one of the most common is gastric bypass. Anti-obesity surgery ameliorates~     diabetes and several other serious comorbidities, but bariatric surgery is also associated~     with medical and nutritional complications.~      Post-gastric bypass hyperinsulinemic hypoglycemia is a relative rare but serious complication~     often seen months to years after gastric bypass surgery. The patients experience~     neuroglycopenic symptoms (eg. inability to concentrate, weakness, altered mental status, loss~     of consciousness).~      The purpose of this study is to determine whether glucagon-like peptide-1 (GLP-1)or other~     enteropancreatic factors (eg. gastric emptying rate) are responsible for the excessed insulin~     secretion seen in some patients after bariatric surgery.~   "
130002|NCT01865747|"~     The purpose of this study is to evaluate the effect of Cabozantinib (XL184) compared with~     Everolimus (Afinitor) on progression-free survival (PFS) and overall survival (OS) in~     subjects with advanced renal cell cancer that has progressed after prior VEGFR tyrosine~     kinase inhibitor therapy.~   "
130003|NCT01865734|"~     Plantar heel pain (PHP) is one of the most common foot conditions in podiatry and physical~     therapy practice and often is associated with chronic symptoms, and disability. Persistence~     of symptoms adds to the economic burden of PHP and cost-effective solutions are needed to~     reduce this burden. Currently, there is wide variation in treatment, cost, and outcomes of~     care for PHP. Two practice guidelines are available to direct management patterns, but the~     guidelines and recent evidence of PHP interventions are unclear about the timing and~     influence of physical therapy in the multidisciplinary management of PHP. The purpose of this~     investigation is to compare the outcomes and costs associated with early physical therapy~     (ePT) following initial presentation to podiatry versus usual podiatric care (uPOD) in~     individuals with PHP. It is hypothesized that there will be greater improvement and/or~     reduced costs associated with either ePT or uPOD. In this study, 112 individuals with PHP~     will be randomized to receive uPOD or ePT after an initial visit with a podiatrist. Treatment~     provided in the uPOD group will reflect usual management patterns and intervention will be~     determined by the podiatrist. Treatment provided in the ePT group will be determined by the~     physical therapist and will focus on impairment-based manual therapy and exercise to the~     lower half of the body. In addition, evidence-based pain modulating modalities will be~     integrated into ePT treatment. Comparisons will be made between groups in the Foot and Ankle~     Ability measure (FAAM), the European Quality of Life (EQ-5D), Numeric Pain Rating Scale~     (NPRS), Global Rating of Change (GROC), and cost of treatment at 6, 26, and 52, weeks. The~     association between successful outcome based on GROC score and patient expectation of~     physical therapy or podiatry, and general expectations of symptom improvement will be~     analyzed. The results of this investigation will help to determine the impact of ePT to~     inform practice, update existing guidelines to reduce practice variation, and identify the~     most cost effective treatment for patients with PHP.~   "
130004|NCT01865721|"~     This study will randomise patients undergoing screening colonoscopy to receive Entonox either~     continuously or as required.~      Both these methods are used in the published studies of Entonox and in clinical practice.~      Null hypothesis There will be no difference in pain levels between these two methods of~     Entonox administration~   "
130005|NCT01865708|"~     Hypothesis 1: Blood alcohol concentration will be <25 mg/100ml (equivalent to a blood alcohol~     concentration of <0.025%) after a 1 hour urinary catheter ethanol lock.~      Hypothesis 2: Daily urinary catheter ethanol locks will not result in increased hematuria or~     increased urinary white cells.~   "
130006|NCT01865695|"~     Faecal elastase is an enzyme test used to identify the presence of pancreatic exocrine~     insufficiency. This condition manifests with symptoms of diarrhea, weight loss, causing~     potential impairment on an individual's quality of life. Creon, a pancreatic enzyme~     supplement, marketed by Abbott Laboratories, Inc. is currently the standard treatment for~     this condition. However, there has been limited work evaluating the merits of this medication~     in this condition. This study aims to evaluate the benefits that Creon may have in coeliac~     patients with low faecal pancreatic elastase by randomising patients with low faecal~     pancreatic elastase (<200 ug/g) to either treatment with Creon or placebo. Outcome measures~     that we aim to assess to determine the benefits of Creon include evaluation of stool~     frequency, abdominal pain, body mass index (BMI) and quality of life.~   "
130038|NCT01865279|"~     This trial is conducted in Europe. The aim of this trial is to investigate the safety,~     tolerability, pharmacokinetics (the exposure of the trial drug in the body) and~     pharmacodynamics (the effect of the investigated drug on the body) of insulin degludec~     (insulin 454), an explorative formulation, not similar to the proposed commerical~     formulation.~   "
132201|NCT01836939|"~     The purpose of this study is to evaluate the safety and effectiveness of CNDO 201Trichuris~     suis ova (TSO) for the treatment of moderate to severe plaque psoriasis.~   "
130007|NCT01865682|"~     The purpose of this study is to quantify changes in ankle and knee motion and force resulting~     from five progressive modifications to the anterior-posterior trim lines of thermoformed~     ankle-foot orthoses (AFO). It is hypothesized that the AFO with the most anterior trim line~     will prevent the most plantar flexion during loading response (the first 10% of the gait~     cycle)and prevent the most dorsiflexion at terminal stance (from 30 to 50% of the gait cycle)~     as compared to the non-device condition. This will be evidenced by the sagittal plane ankle~     motion and ground reaction force magnitude and location during loading response and terminal~     stance. Additionally, the angular velocity of knee flexion will increase during these same~     periods. By contrast, as the trim lines are moved more posterior this will result in lowering~     the effective stiffness of the device which will result in progressive increases in~     dorsiflexion and allow increasing amounts of knee flexion during terminal stance.~   "
130008|NCT01865669|"~     Women with advanced maternal age and morbid obesity, have a higher incidence of labor~     induction/ augmentation and cesarean section (CS), and are at a greater risk for postpartum~     hemorrhage (PPH). Oxytocin is the first line drug in the treatment of PPH, however, oxytocin~     receptor (OTR) desensitization has been recognized in the context of prolonged labors~     secondary to either endogenous or exogenous oxytocin exposure. It is unknown if oxytocin~     desensitization specifically affects contractility in women with advanced maternal age and~     morbid obesity when compared to younger or normal weight populations. Further it is not known~     if the higher incidence of PPH seen in these women is due to poor uterine contractility~     and/or poor response to oxytocin.~      The investigators hypothesize that women with advanced maternal age and morbid obesity will~     exhibit poor myometrial contractility as compared to women that are younger and of normal~     body habitus, in both oxytocin pre-treated and untreated myometrium.~   "
130009|NCT01865656|"~     To evaluate the effectiveness of a First Referral Unit (FRU) Emergency Obstetric and Newborn~     Care (EmONC) skills and drills intervention, to estimate the appropriateness and~     effectiveness of referrals in intervention arm compared to control arm and to calculate the~     incremental cost and cost effectiveness of EmONC skills and drills intervention.~   "
130010|NCT01865643|"~     The aim of this study is to compare the hemodynamic response to tracheal intubations using~     the standard technique versus the alternative GS intubation technique. As secondary outcomes~     the investigators will analyze procedure time, success rate and injury rate.~      The investigators hypothesize that the alternative intubation technique will have a shorter~     procedure time and lower injury rate when compared to the standard technique of GS~     intubation.~   "
130011|NCT01865630|"~     Subarachnoid hemorrhage (SAH) is a special type of stroke that typically results from a~     ruptured intracranial aneurysm, a weakening in the wall of a blood vessel. This type of~     life-threatening bleeding occurs in over 3000 Canadians per year, usually in working age~     adults. Although this type of stroke accounts for only 5-10% of strokes, it contributes a~     disproportionately larger percent of overall stroke morbidity and mortality due in part to~     the young age of those affected. If one is fortunate enough to survive the initial bleeding~     episode and the subsequent surgical treatment of the aneurysm, a patient may still develop~     secondary strokes 3 to 14 days after the initial bleed. These delayed strokes are the most~     significant cause of morbidity and mortality after SAH and may be potentially preventable.~     Currently, there is only one medication (an anti-hypertensive) that has convincingly shown to~     improve outcomes after SAH. The molecular pathway causing these delayed strokes is still not~     clear, and this is an active area of research.~      Animal studies have revealed that these delayed strokes may be caused by a pro-inflammation~     molecule called tumor necrosis factor alpha (TNFa). Delayed strokes were prevented~     experimentally by a TNFa blocker called etanercept. This clinical study, utilizing~     prophylactic treatment with etanercept in patients with SAH, will ensure the safety of this~     drug and determine its effectiveness in preventing delayed strokes.~   "
130012|NCT01865617|"~     This phase I/II trial studies the side effects and best dose of laboratory treated T cells to~     see how well they work in treating patients with chronic lymphocytic leukemia, non-Hodgkin~     lymphoma, or acute lymphoblastic leukemia that have come back or have not responded to~     treatment. T cells that are treated in the laboratory before being given back to the patient~     may make the body build an immune response to kill cancer cells.~   "
130013|NCT01865604|"~     The aim of the study is to investigate whether there is a polarity-specific influence of tDCS~     on cerebral vasomotor reactivity monitored by transcranial doppler sonography.~   "
130014|NCT01865591|"~     The aim of this study is to assess the potential therapeutic benefit of catheter-based renal~     sympathetic denervation using therapeutic unfocussed ultrasound in a single-arm feasibility~     trial.~   "
130015|NCT01865578|"~     Patients suffering from anti-NMDA receptor encephalitis show impaired NMDA-receptor dependent~     neuronal transmission. Furthermore, they often have cognitive deficits of different~     magnitude. Impaired neuronal signaling of NMDA-receptors very likely result in decreased~     cortical synaptic plasticity. Thus, this represents one major reason of cognitive deficits.~     Synaptic plasticity can be assessed in humans via the non-invasive technique of transcranial~     magnetic stimulation (TMS).~      The current study aims to investigate whether learning ability and also cortical plasticity~     can be changed by applying sessions of transcranial direct current stimulation (tDCS).~     Therefore, we are recruiting 10 to 15 patients suffering from anti-NMDA receptor encephalitis~     as well as healthy controls in order to compare tDCS effects. Learning ability is assessed by~     motor sequence tasks, whereas cortical plasticity is measured via TMS.~      tDCS is a novel non-invasive technique allowing induction of changes in cerebral excitability~     level and also cortical plasticity. Previous studies showed positive outcome of anodal~     stimulation on learning tasks. Especially motor learning seems to be an important target for~     tDCS treatment since it showed best results for both post-stroke patients and healthy~     subjects. Multiple sessions of tDCS are inducing long-term effects and improved learning~     function, which were present three months after stimulation.~      In this study we hope to reveals new insights into the pathomechanisms of impaired cognitive~     and learning abilities in patients having anti-NMDA receptor encephalitis. Moreover, we~     evaluate whether tDCS is an effective treatment for patients with cognitive and learning~     deficits.~   "
133348|NCT01821885|"~     The aim of the study is to asses the efficacy of the spirometry and a minimal smoking~     cessation counselling intervention to quit smoking after a year in patients older than 40~     years, smokers of more than 10 packs-year and without a chronic obstructive pulmonary disease~     (COPD) diagnosis.~   "
130016|NCT01865565|"~     Gastrointestinal stromal tumors (GISTs) are a form of sarcoma and the most common sarcoma~     tumors of the gastrointestinal tract. The limited clinical experience suggests that GIST~     patients may benefit from neo-adjuvant therapy from primary GIST. This is a prospective,~     multicenter, open, observational study in evaluation of safety and efficacy of imatinib~     compared with that of historical data for locally unresectable advanced GIST without~     metastasis. The study will include an up to 28-day screening period, followed by receiving~     imatinib mesylate (400 mg/day) for at least 6-12 months and followed up for 3 years after~     surgery.~   "
130017|NCT01865552|"~     The purpose of this study is to compare the pharmacokinetics, safety and immunogenicity of~     SB4 and Enbrel (EU sourced Enbrel and US sourced Enbrel) in healthy male subjects.~   "
130018|NCT01865539|"~     A randomized sham controlled trial evaluating the efficacy of the use of custom foot~     orthotics in veterans suffering from chronic lower back pain. The current study hypothesizes~     that those veterans with chronic lower back pain who receive the custom foot orthotics will~     show greater improvements in pain and disability associated with the chronic lower back pain~     than those who receive the sham orthotic.~   "
130019|NCT01865526|"~     The dietary restriction of proteins and sodium is a cornerstone in the treatment of chronic~     kidney disease (CKD) and of its metabolic consequences. Dietary adjustments in CKD are~     complex and the patients' compliance is very low. A dietary interview method is a validated~     instrument to evaluate the patients' compliance; however, it the presence of a dedicated~     dietitians. For these reasons, and because of the absence of dedicated dietitians in many~     nephrology centres, it is usual practice to give standard low protein diets to CKD patients~     not on dialysis.~      Aim of this study was to verify if few simple tips were able to reduce protein, phosphate and~     sodium intake in patients with CKD, as compared to the practice of giving a low protein diet~     elaborated by a renal dietitian.~   "
130020|NCT01865513|"~     International multicenter observational study of a random-sample cohort of patients~     undergoing any in-hospital surgical procedure under general or regional anaesthesia during a~     continued 14-day period of recruitment.~      Primary hypothesis of this study is that the use of muscle relaxants, their reversal agents,~     or neuromuscular monitoring increases the incidence of postoperative pulmonary complications.~     The secondary hypothesis is that the use of muscle relaxants increases in-hospital mortality.~   "
130021|NCT01865500|"~     Chronic obstructive pulmonary disease (COPD) is a common disease that has a chronic and~     progressive course. Patients with COPD may have exacerbations one to four times in a year.~     Numbers of exacerbations are important because of increased morbidity and mortality and~     healthcare costs.~      Systemic corticosteroids (SC) are recommended in the management of exacerbations of COPD as~     well as bronchodilator, oxygen and antibacterial treatment by all international guidelines.~     However, there are still some concerns about systemic corticosteroid use because COPD~     patients are older and relatively immobilized. In addition, exacerbation rate is~     significantly higher in a group of COPD patients, and these patients need higher amounts of~     SC in order to control of exacerbation. It results in some adverse effects such as~     osteoporosis and bone fractures, thinning of the skin, posterior subcapsular cataract~     formation, glucose intolerance and myopathy. Thus, this condition leads clinicians to seek~     alternative options. However, there are few studies showing that nebulized steroids (NS) are~     as effective as SC in exacerbations of COPD and the optimal NS dose is not certain.~      The investigators aimed to determine the optimal NS dose and evaluate the efficacy and safety~     of NS compared with SC in the treatment of patients with COPD exacerbations requiring~     hospitalization.~   "
130022|NCT01865487|"~     This is a Phase I/IIa, double-blind, randomized, placebo-controlled, dose- and~     regimen-finding study in healthy adults with and without LTBI, who are BCG-vaccinated, HIV~     negative, and have no history or evidence of TB disease. The investigational product is~     AERAS-456 at 3 dose levels: 5, 15, and 50ug of H56 antigen with 500 nmol IC31. The vaccine is~     administered by IM injection.~   "
130023|NCT01865474|"~     This is a prospective, double-blind, randomized, and controlled study. The investigational~     product, DLBS1033 at a dose of 490 mg thrice daily or placebo, will be given for an 8-week~     course of therapy.~      DLBS1033 effectively demonstrated fibrinolytic, fibrinogenolytic as well as antithrombotic~     activities. Hypercoagulation state with high fibrinogen level is usually found in diabetes~     mellitus patients.~      Therefore, the hypothesis of interest of this study is that DLBS1033 will reduce fibrinogen~     level of diabetes mellitus patients better than that of the Control Group.~   "
130024|NCT01865461|"~     MRI, without any contrast injection, allows a non-invasive evaluation and quantification of~     hepatic overloads, especially iron (liver iron content LIC) and fat (steatosis) overloads,~     but in certain clinical circumstances, cases require to improve performances. The aim of the~     study is to add to MRI scans which currently must be performed innovative sequences~     appropriate for the clinical question to overall appreciate on a varied range of patients~     their quality, their robustness, their relative performance and, for patients having a~     biopsy, their accuracy.~   "
130025|NCT01865448|"~     Comparative, randomized, placebo-controlled, single-centre, single-blind clinical trial to~     assess the effectiveness of providing additional DHA omega-3 fatty acids supplements to~     increase the levels of pro-resolving and anti-inflammatory lipid mediators and decrease the~     biological markers of chronic inflammation in obese patients following a weight-loss~     programme.~   "
130026|NCT01865435|"~     Actually, there is an increasing number of arguments for a premature origin of chronic~     adult's diseases, as the chronic obstructive pulmonary disease (COPD). Several factors~     interacting with the foetal or postnatal lung growth are associated with early and~     long-lasting respiratory functional changes susceptible to contribute very significantly to~     the arisen of a COPD in the adulthood. It is possible that these situations reflect phenomena~     of premature cellular senescence, recently involved in the physiopathology of the COPD. An in~     utero exposition to cigarette smoking is one of these situations, because it is known to~     induce, not only functional respiratory changes, but also multiple diseases in the child~     which could testify of cellular ageing phenomena.~      Our project aims to demonstrate that in utero smoking is associated with markers of premature~     cellular senescence in newborn children~      The study will be driven in human newborn child's, with comparison of the length of the~     telomeres in circulating lymphocytes (umbilical blood is collected), according to the~     exposure in in utero smoking and also according to the degree of hypotrophy. This study will~     be a pilot study completed by an animal experimental study.~   "
130027|NCT01865422|"~     Cough is one of the most common reasons for consultation. Even if cough is a non-specific~     symptom, it can be the first sign of a chronic pathology. Several studies have demonstrated~     that chronic cough causes quality-of-life (QoL) impairment. Physicians' incapability to~     evaluate cough impact and patients' QoL has been documented. Therefore, a parent-proxy QoL~     chronic cough specific questionnaire (PC-QOL) has been developed and validated by Chang A. B.~      Objective : The aim of the study is to validate the French version of the PC-QoL, a~     parent-proxy QoL chronic cough specific questionnaire.~      Methods : Linguistic validation will be performed using backward/forward translation~     guidelines, and cognitive debriefing by 10 parents. Psychometric validation will be tested in~     150 patients. Inclusion criteria are: patients with a diagnosis of chronic cough (> 4 weeks);~     18 years of age or younger; all etiologies excepting cystic fibrosis. Informed consent from~     parents will be obtained. At enrollement, each parent will fulfill the PC-QOL questionnaire~     and two cough-related measures (visual analogue score, verbal category descriptive). Clinical~     data (medical history, physical examination) will be collected. Children QoL will be assessed~     using VSPA, Kidscreen and Qualin questionnaires. For assessing reproductibility and~     sensitivity to change, parents will be retested 7 and 21 days later. Content validity,~     construct's validity, external validity and instrument's reliability will be explored.~   "
130028|NCT01865409|"~     Physiological processes leading to a preterm infant to be able to feed orally has not been~     fully understood. The investigators hypothesized that maturation of autonomic nervous system~     may play a major role in this process and kangaroo care may accelerate this maturation. The~     investigators will use heart rate variability to measure the maturation of autonomic nervous~     system.~   "
130029|NCT01865396|"~     The World Health Organization (WHO) defines palliative care as an approach to improve the~     quality of life of patients and their families facing life-threatening illness, through~     prevention and relief of pain and of physical, psychosocial and spiritual problems. The WHO~     stresses that palliative care is applicable early in the course of the illness together with~     other therapies that are intended to cure or prolong life, such as chemotherapy or radiation~     therapy. For the benefit of the patient, palliative care is however often given (too) late in~     the course of the disease of incurably ill patients.~      The aim of our study is to measure the effect of interventional palliative care on quality of~     life, mood and end-of-life care of patients with advanced cancer and their families. These~     patients have a limited life expectancy and a high symptom burden, this leads us to suggest~     that these patients may be benefited with palliative care soon after diagnosis of metastatic~     disease (interventional palliative care).~      The research design of this study is a randomized controlled trial with, on the one hand, an~     intervention group in which patients and their families receive interventional palliative~     care in combination with standard cancer care and on the other hand a control group in which~     patients and their families receive only standard oncologic care. Participants in the~     intervention group will meet the palliative support team shortly after diagnosis. Afterwards,~     the palliative support will meet them at least once a month. This intervention focuses on~     topics such illness understanding, symptom management, decision making and coping with the~     disease. Participants in the control group will only meet with the palliative support team at~     the patient's own request or after referral by the oncologist or the nursing staff.~   "
130030|NCT01865383|"~     Young men who are members of the camps randomized to receive a microfinance and health~     leadership intervention will have a lower incidence of sexually transmitted infections~     (Neisseria gonorrhea (NG), Chlamydia trachomatis (CT) and Trichomonas vaginalis (TV) and~     report perpetrating less physical or sexual violence against sexual partners as compared to~     young men who are members of camps not randomized to receive the intervention.~   "
130031|NCT01865370|"~     The investigators performed a 12-week, randomized, double-blind, placebo-controlled human~     trial to evaluate the efficacy and safety of Kochujang pills on improvement of blood lipids.~     The investigators measured improvement of blood lipids parameters , including Total~     Cholesterol, LDL-C, Triglyceride and HDL-C, and monitored their blood pressure.~   "
130032|NCT01865357|"~     Clinically isolated demyelinating syndromes (CIS) can evolve into multiple sclerosis (MS).~     Cognitive deficiencies could occur at this early stage and concern mainly information~     processing speed (IPS) and their mechanisms are not fully understood. Diffusion Tensor~     Imaging (DTI) can help in the understanding of these mechanisms.~   "
130033|NCT01865344|"~     To provide a preliminary evaluation of the correlation between Numeric rating Score (NRS) and~     skin conductance responses per second at rest and in response to a painful stimulus.~     Sensitivity and specificity will be calculated for NRS and skin conductance responses per sec~     to a standardized painful stimulus. Furthermore, predictors of pain will be examined.~   "
130034|NCT01865331|"~     This trial is conducted in Europe. The aim of this trial is to investigate safety,~     tolerability and pharmacokinetic (the exposure of the trial drug in the body) and~     pharmacodynamic (the effect of the investigated drug on the body) characteristics of insulin~     degludec (insulin 454) and insulin degludec/insulin aspart (IDegAsp) 50 - formerly SIAM),~     both explorative formulations, not similar to the proposed commercial formulation, in healthy~     male Japanese subjects.~   "
130035|NCT01865318|"~     This trial is conducted in Europe. The aim of this trial is to investigate the~     pharmacodynamic (the effect of the investigated drug on the body) of insulin degludec~     (insulin 454), an explorative formulation, not similar to the proposed commercial~     formulation, under single-dose and steady-state conditions in male subjects with type 1~     diabetes.~   "
130036|NCT01865305|"~     This trial is conducted in Europe. The aim of this trial is to compare different ratios of~     explorative formulations, not similar to the proposed commercial formulation, of IDegAsp~     (co-formulation of insulin degludec/insulin aspart and insulin aspart) with separately~     injected, simultaneous doses of insulin degludec (insulin 454), and insulin aspart, compared~     with biphasic insulin aspart 30 in male subjects with type 1 and type 2 diabetes mellitus.~      Trial part 1 is a five-period cross-over trial with incomplete block-design in subjects with~     type 1 diabetes where each subject will be randomised to five out of the ten possible~     treatments. Each treatment consists of an injection of the insulin product followed by a~     euglycemic clamp with a washout period of 7-15 days between treatments.~      Trial part 2 is a three-period cross-over trial with complete blockdesign in subjects with~     type 2 diabetes. Each treatment consists of an injection of the insulin product followed by a~     euglycaemic clamp with a washout period of 7-15 days between treatments.~   "
130039|NCT01865266|"~     Ventilator-associated pneumonia (VAP) is an important cause of morbidity and mortality in~     ventilated critically ill patients specially in intensive care unit (ICU). It is associated~     with an increased duration of mechanical ventilation, high death rates and increased~     healthcare costs in the development country.~      Although VAP is preventable and many practices have been demonstrated to reduce the incidence~     of this disease, the morbidity is still so high. VAP is hard to cure and the mortality is~     about to 40% which was reported in China in 2004. If the bacteria of~     multidrug-resistance(MDR) is isolated, the mortality can increase to 70%. So much more~     methods should be needed in treating VAP in addition to using antibiotics.~      Ulinastatin is a serine protease inhibitor with a molecular weight of 67,000 found in healthy~     human urine. It is used worldwide for patients with inflammatory disorders, including~     disseminated intravascular coagulation(DIC),shock, and pancreatitis . Furthermore,~     ulinastatin administration can help reduce sepsis, prevent multiple organ dysfunction, and~     modulate immune functions.~      Actually, three studies have showed that ulinastatin treatment is associated with reduced the~     levels of inflammatory factors in blood serum in patients with acute respiratory distress~     syndrome(ARDS).Though analyses of serum inflammatory factors such as tumor necrosis factor~     (TNF)-α and interleukin (IL)-6 have been used to determine the degree of systemic~     inflammation under various clinical conditions, they can not reflect the degrees of lung~     infection directly.~      Basing on the results of previous studies, meta analyses and system reviews, the~     investigators hypothesized that the anti-inflammatory function of ulinaststin may also~     decrease the levels of inflammatory factors in bronchoalveolar lavage(BAL) fluid in Patients~     with VAP.~      In addition there is no prospective study to investigate the role of ulinastatin in BAL. The~     investigator hopes that this study can approve the relationship between ulinastatin and~     inflammatory factors in BAL. And it can improve the processes,outcomes and costs of critical~     care as well.~   "
130040|NCT01865253|"~     This is an observational proof of concept study investigating the safety and effectiveness of~     renal denervation to lower blood pressure in people whose blood pressure is not adequately~     controlled due to:~        -  intolerance to antihypertensive medication~        -  inability to take antihypertensive medication due to planned pregnancy~        -  renal artery stenosis~        -  chronic kidney disease~        -  non-compliance to antihypertensive medication~      A total of 125 participants, 25 from each of the groups mentioned above will be recruited to~     the study.~      The duration of this study is 36 months.~   "
130041|NCT01865240|"~     This is a study investigating the effectiveness of renal denervation in lowering blood~     pressure in people whose blood pressure is not adequately controlled despite treatment with 3~     or more blood pressure lowering drugs. The study is designed to compare the effects of renal~     denervation to a usual care group receiving additional blood pressure lowering drugs.~   "
130042|NCT01865227|"~     Obesity has become a global epidemic causing enormous human and economic costs. Incidence~     rates have doubled over the last few decades and obesity-related illnesses such as diabetes~     and cardiovascular diseases now constitute one of the major contributors to the global burden~     of disability. Overall, obesity has been recognized as one of the most pressing public health~     concerns worldwide and effective treatment and prevention strategies are urgently required.~     While behavioral and pharmacological treatments (e.g.low calorie diets, medication) are~     successful means for overcoming overweight and mild obesity, more severe cases of obesity~     usually fail to respond to such interventions. As a result, the demand for weight loss~     surgery is growing among this population. However, uncertainties about the effectiveness of~     obesity surgery persist and high relapse rates (i.e. weight regain) are common. Further~     research in this field is needed to identify risk factors that may trigger relapse and to~     understand patients' treatment needs in greater depth. Previous studies have pointed toward~     high levels of mental health problems among patients. However, the impact of preoperative~     psychopathology on actual surgery outcomes remains unclear. Similarly, few studies have~     investigated the effect of postoperative therapy on patients' psychological functioning and~     weight loss patterns. Research addressing these gaps is imperative to establish best-practice~     approaches. This challenge applies in particular to Middle East and North Africa(MENA)~     countries where research in the field of bariatric surgery and related mental health is~     largely missing. This is a major concern given the fact that the MENA region experienced the~     highest increase in overweight and obesity in recent decades compared to other countries.~      The proposed study aims to address this deficiency by examining obesity surgery patients in~     two Arab countries (UAE and Jordan). The goals of the project are to investigate the nature~     and extent of psychological health concerns among these patients before and after surgery and~     potential associations with treatment outcomes. Moreover, it will test the efficacy of~     post-operative counseling to improve weight loss and psychological health. For this purpose,~     a randomized clinical trial design will be employed so that cause and effect relationships~     between postoperative counseling and treatment outcomes(i.e. weight loss and psychological~     functioning) can be examined experimentally. The study will start by assessing participants'~     psychological health prior to surgery by using standardized self-report measures.~      After surgery, participants will be randomly assigned to either the intervention condition~     consisting of 3-monthly post-operative medical checkups plus group counseling or the~     treatment as usual condition (i.e. 3-monthly standard medical checkups only). Additionally,~     participants' psychological health will be reassessed in both groups at 3, 6, 9 and 12 months~     after surgery. The benefit of the experimental study design is that it allows comparing~     patient outcomes between groups while at the same time controlling for a wide range of~     potential confounding variables.~      The data collected are expected to make a significant contribution to the treatment challenge~     of one of the most pressing public health concerns worldwide. Study results will add to~     clinical practice by broadening and deepening our knowledge of the treatment needs of obese~     patients. By identifying psychological health concerns that may threaten successful treatment~     outcomes high-risk patient groups can be recognized early, which in turn may help to reduce~     postoperative weight regain and other complications.~      To the best of the PI's knowledge, the proposed work would be the first study of this kind in~     the Arab world. Findings will be helpful for developing culturally sensitive and~     evidence-based best-practice guidelines, which are vital to achieve satisfying long-term~     outcomes. Moreover, study results will be relevant for research communities and practitioners~     outside the MENA region since empirical support for the effectiveness of obesity surgery~     remains weak internationally.~   "
130043|NCT01865201|"~     It is hypothesized that excessive generation of free radicals involves in the pathogenesis of~     radiation-induced brain necrosis. This study therefore evaluated the effect of free radical~     scavenger, edaravone, on radiation-induced temporal lobe necrosis (TLN) in patients with~     nasopharyngeal carcinoma (NPC) after radiotherapy.~   "
130044|NCT01865188|"~     To evaluate the blood pressure lowering effect and safety of LCZ696 when given alone and in~     combination with amlodipine in patients with essential hypertension.~   "
130045|NCT01865175|"~     This is a pilot study designed to compare the tolerance of ionic iron (ferrous sulphate) with~     heme iron polypeptide. Subjects will take one week of one product followed by a week with no~     product followed by a week with the other product. Subjects will complete a daily diary to~     assess side effects.~      Hypothesis: Heme iron polypeptide is associated with fewer gastrointestinal side effects than~     ionic iron.~   "
130046|NCT01865162|"~     The first weekly KD meal package will be given to the patient at the study site. The patient~     will be instructed in how to process the week-long meal plan package content. Participants~     will measure urine ketone bodies with Ketostix 2x day and blood for glucose and ketone levels~     using self-administered Precision Xtra® Meter (Abbot Diabetes Care, Alameda, CA, USA)~     starting with the first day of the diet. Self-administered blood checks for glucose and~     ketone bodies will be done in fasted state in the morning and 2 hours post-prandially in the~     evening. Participants will be seen on day 7 of treatment by the study nutritionist and a~     study investigator-physician (separately) to review possible AEs, and for further education~     about the diet. Study staff will review and evaluate the participant's method of urine ketone~     and blood glucose and ketone levels testing. Subsequently, participants will be seen at one,~     2 weeks, and 4 weeks after KG diet initiation, and then monthly. KD treatment will last until~     exit criteria are met or for 6 months, whichever comes first. Exit criteria are the primary~     outcome measures, the first of either (a) cerebral edema requiring steroid rescue therapy or~     (b) death.~      Treatment will occur in outpatient office setting at the Mid-Atlantic Epilepsy and Sleep~     Center, Bethesda, MD. The location of subsequent treatment administration may change to~     hospital setting at Holy Cross Hospital should a patient need hospitalization during the~     study for any reason, as determined by the patient's clinical care needs.~   "
130047|NCT01865149|"~     Studies in patients with intracranial hypertension have shown a good relationship between~     optic nerve sheath diameter measured by retrobulbar ultrasound and invasively measured~     intracranial pressure. The aim of this study was to evaluate changes in optic nerve sheath~     diameter before and after drainage of cerebrospinal fluid in patients with hydrocephalus.~   "
130048|NCT01865136|"~     The aim of this project is to study the safety, efficacy and effectiveness of medical~     treatment of incomplete abortion provided to women by physicians or midwives in Kisumu,~     Kenya.~      In Kenya, Post Abortion Care (PAC), provided by physicians, nurse-midwives and clinical~     officers, has been integrated at private reproductive health facilities since 1998.~     Misoprostol as treatment of incomplete abortion was launched I Nyanza Province in April,~     2012. The involvement of midwives in medical (Misoprostol) treatment of incomplete abortion~     has, however, not been systematically evaluated. There is a need to determine whether~     midwives and physician can perform medical treatment of incomplete abortion equally safe and~     effective in Kenya. The results will thus provide evidence-based information that can~     contribute to the development of strategies to increase women's access to Post Abortion Care~     in Kenya as well as in other low-income contexts.~   "
130049|NCT01865123|"~     The purpose of this study is to compare the effectiveness of the Transcendental Meditation~     (TM) program to the more standard Cognitive Behavioral Therapy with Prolonged Exposure~     (CBT-PE) in treating posttraumatic stress disorder (PTSD) in war Veterans over a three month~     treatment period.~   "
130061|NCT01864967|"~     Carbon dioxide infusion is a non surgical procedure applied via percutaneous, transdermal and~     subcutaneous. Increase in the concentration of carbon dioxide decreases pH activating local~     nitric oxide that stimulates collateral vessels formation, vascular endothelial growth factor~     and basic fibroblast growth factor. Carbon dioxide infusion restores the blood flow in~     chronic wounds of the lower limbs.~   "
130050|NCT01865110|"~     This study aims to evaluate whether the addition of lenalidomide to rituximab-maintenance~     improves progression free survival (PFS) compared to standard rituximab maintenance after~     induction treatment consisting of R-CHOP + R-HAD vs R-CHOP alone in older patients (≥ 60 year~     old) with mantle cell lymphoma.~      The treatments consist of two phases: induction treatment (3 R-CHOP21 + 3 cycles of R-HAD28~     alternating) vs 8 cycles of R-CHOP21) followed by maintenance treatment (13 cycles of~     rituximab + 26 cycles of lenalidomide vs 13 cycles of rituximab).~   "
130051|NCT01865097|"~     Parkinson's disease patients may have severe non-motor symptoms. A common and troublesome~     non-motor symptom is pain. Currently these symptoms are treated with medication with limited~     success. Our study aims to determine whether relaxation guided imagery can alleviate pain in~     Parkinson's disease patients.~   "
130052|NCT01865084|"~     The main purpose of this study is to determine if tadalafil can slow the decline in walking~     ability of boys who have Duchenne muscular dystrophy (DMD). The study will also assess the~     safety of tadalafil and any side effects that might be associated with it in boys who have~     DMD. Participants will receive study treatment (tadalafil or placebo) for the first 48 weeks~     of the study, and can then continue into an open label extension (OLE) that consists of two~     periods during which all participants will receive tadalafil. In OLE period 1, all~     participants will receive tadalafil for 48 weeks. Participants completing OLE period 1 will~     continue into OLE period 2 and will receive tadalafil for at least another 48 weeks.~   "
130053|NCT01865071|"~     Early Closure of Temporary Loop Ileostomy After Rectal Resection for cancer~   "
130054|NCT01865058|"~     Non-Hodgkin lymphoma (NHL) is one of the more frequent cancers in the western world with~     approx. 800 new cases annually in Denmark. Diffuse large B-cell lymphoma (DLBCL) in Denmark~     accounts for almost 40% of newly diagnosed NHL cases. Treatment with the combination of~     chemotherapy and monoclonal antibodies has significantly improved prognosis over the past~     decade, but a large proportion of patients with DLBCL will continue to relapse with our~     current treatment options. Therefore, there is a need for reliable methods for detection of~     treatment response as early as possible in the treatment course in order to identify patients~     who respond poorly to standard treatment and potentially would benefit from a change in~     treatment strategy. This has still not been established, but a valid early marker is required~     in order to allow randomized trials of treatment stratified by early response. One of the~     most promising applications of PET is the metabolic assessment of the early response of~     cancer treatment.~      This study is a national prospective multicenter study emanating from the Danish Lymphoma~     Group (DLG). Patients are scanned after each of the early 4 cycles of chemo therapy. The aim~     is to establish the correct timing of response evaluation. Additionally, the investigators~     wish to investigate the optimal qualitative and quantitative method of response assessment in~     order to predict post-therapeutic remission and long-term prognosis.This study will~     contribute to interim-PET being implemented in the most optimal way in daily clinical~     practice.~   "
130055|NCT01865045|"~     This is a multicenter retrospective analysis .The aim of the present study is to investigate~     the molecular predictors of vinorelbine response in tumor samples of a series of MPM patients~     and evaluate the possible impact on clinical outcome.~      Sample size: around 150 patients based on the availability of tumor size~   "
130056|NCT01865032|"~     This study is a single-site trial assessing the specificity of CL Detect™ Rapid Test versus~     the gold standard for Leishmania diagnosis in the US which is microscopic identification of~     Leishmania amastigotes in a stained lesion sample. Subjects will be patients who present for~     dermatology consultation with a primarily ulcerated lesion. After informed consent is~     obtained and the subject is screened for eligibility, 2 diagnostic samples will be collected~     from the subject's lesion in the following order: 1) one sample will be obtained with a~     dental broach for use with the CL Detect™ Rapid Test and 2) a second sample will be obtained~     by scraping for use in the microscopic identification of amastigotes. Samples will be~     analyzed by microscopy and CL Detect™ Rapid Test. The CL Detect™ Rapid Test will be performed~     by different operators who are clinical staff members. These staff members, blinded to each~     other's results, will evaluate the samples from each method independently. Each of the 150~     study subjects will be followed administratively to the point where a diagnosis is~     established (if possible) for their tested lesion, even if that diagnosis is not cutaneous~     leishmaniasis (CL). If a specific diagnosis cannot be determined for a non-CL lesion, the~     investigator will assign a likely etiology (eg, infectious, oncological, immunological,~     vascular, or undetermined/other origin). Based on the diagnosis determined for each lesion,~     subjects will be referred for appropriate treatment.~   "
130057|NCT01865019|"~     pressure controlled ventilation will improve oxygenation indices , hemodynamics during~     anesthesia for living donor liver transplantation recipients ,improving postoperative graft~     function and decreasing postoperative pulmonary complications~   "
130058|NCT01865006|"~     The purpose of this study is to compare effect of sutureless thyroidectomy with vessel~     closure devices and conventional thyroidectomy with suturing on voice quality with phoniatric~     evaluation.~   "
130059|NCT01864993|"~     Non Celiac Gluten Sensitivity (NCGS) is an emergent syndrome mainly inducing gastrointestinal~     symptoms. NCGS is suspected to be present in the 6% of the population and thus it represents~     an important issue in health care. Actually it remains difficult to diagnose and prove due to~     the lack of established criteria. The investigators intention is to establish a diagnostic~     flowchart to evaluate the real impact of NCGS in a cohort of patients suffering from~     functional gastrointestinal symptoms.~   "
130060|NCT01864980|"~     Certain types of surgery are associated with occult blood loss, which is hard to detect~     intraoperatively by intermittent conventional, invasive Hb concentration measurements using~     the clinical standard of Hb monitoring by satellite laboratory analysis (Hbsatlab). The~     investigators want to see whether continuous non-invasive transcutaneous Hb measurement using~     a finger sensor (SpHb), (a) reduces the total time (area under the curve, AUC) a patient's Hb~     is below a predetermined transfusion threshold (HbAUC) for administration of red blood cell~     concentrate (RBC), and (b) prevents a decrease in total oxygen delivery (DO2) possibly~     associated with transfusion below a critical haemoglobin concentration. Furthermore, the~     investigators want to study if SpHb monitoring changes the timing of RBC administration and~     reduces the need for intra- and post-operative RBC transfusion.~   "
130062|NCT01864954|"~     This study seeks to develop and test a Web-based tobacco relapse prevention program targeting~     postpartum women who quit smoking for pregnancy. Participants are randomly assigned to one of~     two conditions: (1) an Enhanced Web+phone Condition that receives access to an interactive~     Web-based intervention plus up to 3 brief supportive phone calls from a personal coach; (2) A~     Basic Web Information-Only Control Condition that receives access to an informational website~     plus an introductory phone call. The hypothesis is that Women in the Enhanced Condition will~     be more successful in avoiding tobacco relapse than women assigned to the Basic Control~     Condition.~   "
130063|NCT01864941|"~     To investigate the safety and tolerability of balloon venoplasty compared to sham in Multiple~     Sclerosis patients with Chronic Cerebrospinal Venous Insufficiency (CCSVI) as measured by~     adverse events occurring within 48 weeks of the procedure.~   "
130064|NCT01864928|"~     Despite abundant evident supporting the use of acute reperfusion therapy in the setting of~     acute ischemic stroke (AIS), adoption of this practice in routine clinical care is poor. We~     hypothesize that a significant barrier is the difficulty in weighing the benefits and risks~     of rt-PA treatment in the care of an individual patient, a problem compounded by the time~     urgency of decision-making and clinical fears that weigh risks of treatment more heavily than~     benefits.~      The goal of this Quality Improvement (QI) study is to leverage an IT solution that we have~     developed, ePRISM, that executes multivariable risk models with patient-specific data so that~     a personalized estimate of an individual's outcomes (both risks and benefits) with and~     without rt-PA, can be generated so support safer, more effective clinical care. Through an~     earlier project, we will have programmed ePRISM with the best available risk-stratification~     models and developed a clinically useful format for presenting the data to support clinical~     decision-making in AIS.~      Through QI, we propose to identify the optimal mechanism for integrating the tool within the~     routine flow of patient care in preparation for more definitive studies, or dissemination~     strategies, to improve the treatment of patients with AIS.~   "
130065|NCT01864915|"~     Colon capsule endoscopy is a new technology that is a noninvasive method of examining the~     large bowel. The bowel preparation required for this test differs from colonoscopy in that it~     needs to clean the colon but also needs to provide propulsion. Most published studies have~     used medications as part of their regime that are not available in parts of North America~     (ex. sodium phosphate) and have shown poor test completion, bowel preparation and polyp~     detection rates.~      Objective: In this study a bowel preparation for the colon capsule is proposed that uses~     medications approved for use in Canada that may provide a better preparation quality and~     better completion rates.~      Methods: Patients who are being referred for a colonoscopy will be recruited to participate~     in the study. They will all receive split-dose polyethylene glycol (PEG) for bowel~     preparation. They will be randomized to receive either 1) Prucalopride 2mg daily for four~     days, 2) Prucalopride 2mg daily for four days plus a Prucalopride booster, or 3) Prucalopride~     2mg for four days plus 1 and 1/2 sachets of Picosalax boosters for the colon capsule study.~     The day after the colon capsule they will drink PEG ( 2 Liters) at 5am -or approx 4hrs prior~     to procedure time and return for a colonoscopy. The colon capsule results will be reviewed by~     two endoscopists experienced in video capsule endoscopy who will assess the bowel preparation~     using a previously defined scale and examine for polyps. We propose that administering~     Prucalopride daily for 4 days will increase intestinal motility and improve colon capsule~     completion rates and a booster dose of Picosalax will improve colon capsule completion rates~     compared to prucalopride by itself.~   "
130066|NCT01864902|"~     RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory~     into patient autologous or donor-derived T cells may make the body build immune response to~     kill cancer cells.~      PURPOSE: This clinical trial is to study genetically engineered lymphocyte therapy in~     treating patients with CD33 positive acute myeloid leukemias that is relapsed (after stem~     cell transplantation or intensive chemotherapy) or refractory to further chemotherapy.~   "
130067|NCT01864889|"~     RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory~     into patient autologous or donor-derived T cells may make the body build immune response to~     kill cancer cells.~      PURPOSE: This clinical trial is studying genetically engineered lymphocyte therapy in~     treating patients with B-cell leukemia or lymphoma that is relapsed (after stem cell~     transplantation or intensive chemotherapy) or refractory to chemotherapy.~   "
130068|NCT01864876|"~     This protocol is for a phase 1, randomized, single-blinded study to evaluate the safety and~     tolerability of a single 5 mcg dose of GLA-SE administered intramuscularly and GLA-AF~     administered subcutaneously. The second focus will be to detail the global immune response by~     measuring systemic cytokines, chemokines, and global gene regulation. The third focus will be~     to investigate the effects of GLA on the peripheral blood immune cells including monocytes~     and dendritic cells. The results of this trial will generate supportive human data to use GLA~     as an adjuvant in a dendritic cell-targeted vaccine strategy.~   "
130069|NCT01864863|"~     The purpose of this study is to compare the pharmacokinetics of two Traclear 62.5 mg tablets~     and one HGP1206 125 mg tablet in healthy male volunteers.~   "
130070|NCT01864850|"~     Randomized comparison between standard radiotherapy and hypofractionated split course~     schedule. Compared to standard radiotherapy, the investigators expect that hypofractionated~     split course (interruption of 2 weeks) radiotherapy will improve compliance to treatment,~     acute tolerance of treatment, preservation of autonomy, prevention of malnutrition, with the~     same efficacy, measured by the locoregional control rate.~   "
130071|NCT01864837|"~     The aim of the proposed study is to investigate the agreement between the measurement of the~     tongue diagnosis system (TDS) and the conventional way of tongue diagnosis about the tongue~     coating thickness (TCT) in the tongue diagnosis of the traditional Korean medicine (TKM).~   "
130093|NCT01864551|"~     The investigators hypothesized that olanzapine will be superior to lamotrigine in the~     prevention of any kind of recurrence of bipolar disorder. On the other hand, lamotrigine~     group will have better prevention of depressive episode than olanzapine group. Meanwhile, the~     investigators supposed that there will be more concomitant medicine in lamictal group than~     olanzapine group. The comorbidity will influence the measurement of outcome such as time~     period of recurrence of depressive episode in both groups..~   "
130094|NCT01864538|"~     The primary objective of this study is to determine the response rate, duration of~     response,progression-free survival and overall survival of subjects with advanced melanoma~     treated with TH-302.~   "
130072|NCT01864824|"~     In this study, the pills formulated are being used to try to ameliorate the effect of air~     pollution on epigenetic changes, specifically DNA methylation, potentially linked with~     particulate matter air pollution inhalation and cardiovascular health effects. The way in~     which this is achieved is that the vitamins, which act as methyl donors, add a methyl group~     to the DNA to reverse the loss observed on exposure to air pollution.~      Specifically for this study, the methyl donor supplement has been made by Jamieson~     Laboratories, and consists of 50mg Vitamin B6 and 1 mg Vitamin B12, (both within Health~     Canada approved limits) and 2.5 mg folic acid. The non-vitamin ingredients are those commonly~     used in pill formation. However, the folic acid concentration is 2.5mg, which is above the~     1.0mg limit set by Health Canada for a natural health product. This concentration, however,~     has been used in previous academic studies safely and effectively, and was also formulated by~     Jamieson Laboratories. (ClinicalTrials.gov number, NCT00106886; Current Controlled Trials~     number, ISRCTN14017017. HOPE2 study).~   "
130073|NCT01864811|"~     A randomized control trial investigating if an early intervention program of modified~     Constraint Induced Movement Therapy for babies, Baby-CIMT, performed before 12 months of age~     will improve hand function in children with risk for developing cerebral palsy.~   "
130074|NCT01864798|"~     This is a prospective, single arm phase IIa trial in which patients with early breast cancer~     will receive pre-operatively two doses of denosumab 120mg subcutaneously one week apart~     (maximum 12 days) followed by surgery. Tumor, normal breast tissue and blood samples will be~     collected at baseline and at surgery. Post-operative treatment will be at the discretion of~     the investigator.~      Primary objective: to determine if a short course of RANKL inhibition with denosumab can~     induce a decrease in tumor proliferation rates as determined by Ki67 immunohistochemistry~     (IHC) in newly diagnosed, early stage breast cancer in pre-menopausal women.~      Secondary objectives:~        -  To determine the number of absolute Ki67 responders after a short course of denosumab~          (defined as <2.7% IHC staining in the post treatment tumor biopsy).~        -  To determine the effects of a short course of denosumab on serum C-terminal telopeptide~          levels (CTX).~        -  To determine the effects of a short course of denosumab on RANK/RANKL gene expression~          and signaling as assessed by immunohistochemistry (IHC) and RNA sequencing in the tumor.~        -  To determine the effect of a short course of denosumab on tumor apoptosis rates using~          IHC~        -  To determine the effect of a short course of denosumab on modulating the immature~          mammary epithelial cell populations in the tumor.~        -  To determine the effect of a short course of denosumab on estrogen signaling pathways in~          the tumor.~        -  To determine the effect of a short course of denosumab on various immune~        -  To determine effect of safety profile of denosumab~   "
130075|NCT01864785|"~     Nearly 90% of all spinal fractures occur in the thoracolumbar region, and burst fractures are~     composed of 15% of such injuries. But the treatment of thoracolumbar fractures remains~     controversial. Treatment varies from the conservative management to various types of surgery.~     Internal fixation with spinal fusion is a surgical treatment method that is generally~     accepted for patients with thoracolumbar fracture. In this department, the investigators~     treat thoracolumbar burst fracture with posterior fixation alone and combined with articular~     process fusion. To evaluate the result of the two kinds of treatment, the investigators~     design this clinical trial. So, the investigators compared the radiological and clinical~     outcomes between patients who underwent posterior fixation alone and supplemented with fusion~     following the onset of thoracolumbar burst fractures.~   "
130076|NCT01864772|"~     The aim of the trial is to evaluate the clinical benefit (efficacy, safety, preservation of~     autonomy) of cetuximab-carboplatin-5FU combination as first line treatment of recurrent or~     metastatic head and neck squamous cell carcinoma in patients over 70 years without frailty~     (after geriatric assessment).~   "
130077|NCT01864759|"~     The investigators will evaluate the safety of a single endovenous infusion of ICOVIR5 in~     adults with locally advanced and metastatic melanoma. ICOVIR5 consists in a conditionally~     replicative or oncolytic adenovirus.~   "
130078|NCT01864746|"~     The PENELOPEB study is designed to demonstrate that in the background of standard~     anti-hormonal therapy palbociclib provides superior invasive disease-free survival (iDFS)~     compared to placebo in pre- and postmenopausal women with HR-positive/HER2-normal early~     breast cancer at high risk of relapse after showing less than pathological complete response~     to neoadjuvant taxane- containing chemotherapy. Considering the high risk of recurrence in~     patients after neoadjuvant chemotherapy and a high CPS-EG score, palbociclib appears to be an~     attractive option with a favourable safety profile for these patients.~   "
130079|NCT01864733|"~     The treatment of chronic heart failure (CHF) is a key challenge in public health. Despite~     medical advances, 1-year mortality of NYHA III-IV CHF is 28%. Undernutrition is an~     independent risk factor for mortality and complications. Up-to-date, interventional studies~     involving nutrition are scarce in CHF. Academic societies are recommending the use of oral~     nutritional supplements (ONS) in case of weight loss, without defining the modalities. ONS~     could improve nutritional status in undernourished CHF patients, but solely administered,~     have a limited impact on undernutrition, physical performance and prognosis. A multimodal~     approach integrating physical exercise, nutritional intakes, polyunsaturated n-3 fatty acids~     (n-3 PUFA), and anabolizing hormones, has to be privileged. A recent trial has shown the~     clinical benefits of such an approach in patients with chronic respiratory insufficiency~     (CRI), who have similar nutritional and muscular characteristics.~      Exercise rehabilitation is well validated in CHF patients, but has never been validated in~     case of undernutrition. Exercise rehabilitation allows improving exercise capacity, quality~     of life and cardiovascular outcomes including mortality.~      N-3 PUFA supplementation improves muscle strength and endurance in CRI patients. n-3 PUFA~     supplementation decreases by 30% cardiovascular mortality of CHF patients. n-3 PUFA could be~     useful for CHF patients rehabilitation.~      Androgenopenia is a prognostic factor in CHF. Androgen substitution improves significantly~     muscle strength, walking endurance and quality of life. In the context of a multimodal~     approach, Androgen substitution together with exercise rehabilitation and ONS could have a~     beneficial effect on muscle mass, strength and endurance of CHF patients, as already~     described in CRI, elderly and HIV patients.~      The study hypotheses that a 3-month multimodal approach associating exercise rehabilitation,~     androgen substitution, n-3 PUFAs and ONS improves exercise capacity of undernourished CHF~     patients.~   "
130095|NCT01864525|"~     Essential voice tremor is a neurological condition that produces a regular, shaking quality~     in the voice. One form of drug treatment that produces some improvement in tremor of the~     hands is octanoic acid, which is a food additive that is similar to alcohol. Research~     suggests that octanoic acid may reduce tremor in the hands/arms with few side effects and no~     intoxication effects. This study will determine whether octanoic acid may be useful for~     reducing tremor when it affects the voice. Researchers are hypothesizing that octanoic acid~     will reduce the effects of tremor on the voice.~   "
130096|NCT01864512|"~     This project was undertaken by Qilu Hospital of Shandong University and other well-known~     hospitals in China. In order to report the alteration of Different Immune Parameters in ITP~     Patients Receiving Eltrombopag Treatment.~   "
130080|NCT01864720|"~     Insomnia is very common in cancer patients. When left untreated, insomnia can lead to~     numerous serious consequences (e.g., psychological disorders) for the individual and~     significant costs for society (e.g., increased medical consultations). Cognitive-behavioural~     therapy (CBT), a form of psychotherapy, is now considered the treatment of choice for~     insomnia and its efficacy has been demonstrated in clinical studies conducted in cancer~     patients. Unfortunately, CBT for insomnia (CBT-I) is not widely accessible as only a few~     cancer clinics have mental health professionals formally trained in the administration of~     this treatment. Innovative models of treatment delivery are therefore needed to make sure~     that every cancer patient with insomnia receives the care he/she needs. A stepped care~     approach in which patients only receive the level of treatment that they need, beginning with~     a minimal, less costly, intervention followed by more intensive treatment if required, has~     shown some promises for other psychological disorders (e.g., depression). Although its~     relevance has been emphasized to make CBT-I more accessible, its utility has never been~     investigated. The main goal of this randomized non-inferiority study is to assess the~     efficacy and costeffectiveness of a stepped care CBT-I as compared with standard care. Our~     hypothesis is that a stepped care approach will not be statistically inferior in terms of~     efficacy as compared to usual care, while being much less costly (better cost-effectiveness~     ratio). Three hundred cancer patients (mixed cancer sites) with insomnia symptoms will be~     assigned to: (1) stepped care CBT-I (n = 200) or (2) standard care (n = 100), consisting of 6~     weekly sessions administered individually by a professional.~   "
130081|NCT01864707|"~     The main aim of this trial is to evaluate whether additional acupuncture or mindfulness-based~     stress reduction is more efficacious than usual care only to reduce fatigue in patients with~     multiple sclerosis.~   "
130082|NCT01864694|"~     The aim of this study is to compare a Web-based system and a computer telephone system to~     determine their effectiveness in improving diet behaviors compared to each other and a~     control group.~   "
130083|NCT01864681|"~     The purpose of this study is to determine whether metformin in combination with gefitinib are~     effective in patients with previously untreated advanced or metastatic Non-Small-Cell Lung~     cancer with epidermal growth factor receptor (EGFR) mutations~   "
130084|NCT01864668|"~     Measure the lung strain in different tidal volume in ADRS patients to find the relationship~     between tidal volume and lung strain and find the most suitable tidal volume for each~     patient.~   "
130085|NCT01864655|"~     Alzheimer's disease is a devastating neurodegenerative disorder, for which there is currently~     no effective treatment to slow or halt progression. Beta amyloid peptide accumulates in the~     brains of those with Alzheimer's, and is thought to play a major role in triggering the~     dementia. The investigators recently characterized a molecular pathway by which ß-amyloid~     damages neurons, and showed that the protein termed Fyn kinase is crucial. Our data suggest~     that blocking Fyn will have a significant therapeutic benefit for Alzheimer's. Astra Zeneca~     has developed a blocker of Fyn and related kinases (AZD0530) for the treatment of cancer.~     Chronic AZD0530 administration is well tolerated in humans, and the investigators propose to~     test its potential as a novel Alzheimer's disease modifying therapy. This study will assess~     the safety and tolerability of AZD0530 in patients with Alzheimer's disease.~   "
130086|NCT01864642|"~     The hypothesis is that osteopathic manipulative treatment (OMT)will significantly reduce~     intraocular pressure (IOP) in individuals with ocular hypertension (OHT) and glaucoma suspect~     patients.~   "
130087|NCT01864629|"~     The purpose of this study is to examine the effectiveness of focused family planning~     counseling on the uptake and continuation of highly effective contraceptive methods (defined~     as the intrauterine device, implant, and both male and female sterilization methods including~     vasectomy, tubal ligation and Essure) during the postpartum period in women who have recently~     experienced a preterm delivery.~      The investigators hypothesize that women with a recent preterm birth (PTB) will be more~     likely to initiate and continue using a highly effective method of contraception when~     provided with focused family planning counseling.~   "
130088|NCT01864616|"~     The purpose for this study is to determine the effect of vitamin D supplementation on disease~     activity in Crohn's disease patients in Canada and Saudi Arabia~   "
130089|NCT01864603|"~     The SEARCH study aims to test evidenced-based innovative community based interventions that~     lead to the elimination of HIV in rural communities in East Africa using a multi-disease~     approach. The first phase of the study will quantify the health, economic and educational~     impact of early HIV diagnosis using a streamlined and immediate ART (antiretroviral therapy).~     This first phase will be completed in July 2017. The second phase of the study, will quantify~     the health, economic and educational impact of targeted Pre-Exposure Prophylaxis (PrEP),~     targeted HIV testing and targeted care interventions in the context of universal treatment~     and streamlined care. This second phase will be completed in July 2020. The study~     intervention is designed to improve the entire continuum of care, to reduce structural~     barriers for all populations including those most at risk.~   "
130090|NCT01864590|"~     The open abdomen is a valid and accepted surgical tactic for the trauma and acute care~     patient. There have been many mechanisms described for its management, but the most accepted~     strategy is the vacuum pack. At our hospital the investigators have used for many years a~     double sylo bag, one underneath the fascia and the other sutured to the skin, at the initial~     operation. At subsequent surgeries once the abdomen is clean the investigators leave the same~     subfascial sylo bag and use a prolene mesh attached to the fascia. Every day the~     investigators try to tighten the mesh with sutures until the abdomen can be closed. This~     study´s objective is to compare our double sylo bag- mesh protocol with the vacuum pack to~     determine which is related to a higher fascial closure rate.~   "
130091|NCT01864577|"~     The purpose of this study is to determine whether the use of negative pleural suction in tube~     thoracostomy is more effective than water seal alone for the treatment of pneumothorax and/or~     hemothorax in patients with chest trauma.~   "
130092|NCT01864564|"~     Specific Aim 1: To test the hypothesis that early GDM screening between 14-18 weeks in obese~     women (body mass index ≥30.0) will result in improved perinatal outcomes.~      Specific Aim 2: To test the hypothesis that a lower diagnostic threshold for GDM at 14-18~     weeks will result in improved detection of GDM and reduce the need for third-trimester~     testing.~      Specific Aim 3: To test the hypothesis that 1,5-anhydroglucitol, a sensitive marker of~     hyperglycemia, can be used as a simple and sensitive serum test for GDM in the obese~     population.~   "
130097|NCT01864499|"~     Neurosurgery for supratentorial brain tumor is frequently associated with preoperative~     intracranial hypertension. The evaluation of intracranial pressure is available noninvasively~     by measuring the diameter of the optic nerve sheath ultrasound.~      The evaluation of intracranial pressure by measuring the DNO in perioperative is not~     described in the literature. The investigators propose a pilot study to assess intracranial~     pressure perioperative surgery for supratentorial brain tumor. The investigators consider a~     diameter of the optic nerve sheath as normal and predictive of intracranial pressure below 20~     mm Hg when less than 5.7 mm (on the average of two measurements on each eye). DNO the normal~     healthy adult unanesthetized is 5 mm.~      The main objective of the study is to compare the mean change in diameter of the optic nerve~     between the postoperative and D2 between groups of patients undergoing resection of a brain~     tumor and patients undergoing biopsy brain tumor.~      Pilot Study: Prospective, single-center, controlled, non-randomized, the number of patients~     is estimated according to the recruiting capabilities of neurosurgery for this type of~     patient in the institution, A total of 40 patients: 20 patients Tumor Resection, control~     group: 20 patients Biopsy Brain Tumor.~   "
130098|NCT01864486|"~     This study evaluates the safety and effectiveness of the Intelligent Retinal Implants System~     (IRIS V1)~   "
130099|NCT01864473|"~     Background:Fistula-in-ano is described as Bhagandara in the classics of Ayurveda, is an~     ancient surgical problem. It was commonly described even in the Vedic period. The description~     of Bhagandara, with the full text of its managements, can be gathered from the Sushruta~     Samhita, which is supposed to have been written in the second century B.C. Fistula-in-ano is~     a tubular ulcer formed around the peri-anal region. It may also be found anywhere in the~     perineal region. Its ramifications can extend to the lower back, subscrotal region, vagina~     etc.~      Hypothesis:In Sushruta Samhita(2nd BC) Acharya Sushruta has advocated Kshar Sutra treatment~     due to probability of recurrence after surgery. The present treatment modality Kshar Sutra~     has been found effective and as adjuvant therapy by avoiding recurrence.~   "
130100|NCT01864460|"~     Type 2 diabetes (DM2) affects nearly 20 million people in the United States while impaired~     glucose regulation (IGR), which includes impaired glucose tolerance (IGT), impaired fasting~     glucose (IFG), and early diabetes affects a considerably larger but unknown population group.~     At the current time there is no effective therapy to completely prevent, or reverse~     neuropathy associated with IGR and this represents a considerable challenge in~     rehabilitation. There is a particularly strong incentive to prevent IGT and related~     complications from advancing to DM2. IGR is a growing problem among all older adults and its~     strong association with many functional limitations, particularly mobility limitations, is~     not always recognized, even though diabetes-related disability occurs in up to 2/3 of older~     adults with diabetes and is associated with dependency, poor quality of life, and increased~     acute and long-term care utilization.~      Autonomic dysfunction is a significant problem in subjects with IGT. The Preliminary Data~     shows that over 90% of subjects with IGT have an abnormal score on questionnaires about~     autonomic symptoms such as lightheadedness, dry mouth or dry eyes, pale or blue feet, feet~     that are colder than the rest of the body, decreased sweating in the feet or increased~     sweating in the hands, nausea or bloating after eating, persistent diarrhea or constipation,~     or leaking of urine. In addition, patients with IGR have impaired balance control. These~     factors can increase the risk of falls in affected subjects. A non-randomized and~     non-controlled study showed that a diet and exercise intervention in patients with diabetes~     led to an overall improvement in autonomic function. Furthermore, it was shown that standing~     balance can be improved with a balance intervention program.~      However, there are no published studies that assess the effect of an intense physical~     activity intervention on autonomic function in IGR related neuropathy. This study will test~     an aerobic exercise and balance intervention in participants with IGR. The investigators will~     examine if an individually tailored, carefully monitored, Diet, Physical Activity, and~     Balance Enhancement Program (DPAEP) can improve autonomic function and balance control when~     compared to patients who receive standard care. Improving balance control and autonomic~     function can decrease the risk of falls and have a significant effect on the health of~     participants.~      The research is also significant because it will test subjects either before they become~     diabetic, or at an early stage in their diabetes, thus enhancing the chance of reversing the~     autonomic neuropathy or balance impairment. Furthermore, the study is designed to test~     whether improvement in autonomic function and balance is associated with improvement in~     clinical outcomes, quality of life, and the metabolic state of participants. Thus, the~     proposed interventions are likely to have a real life impact on participants and their~     health.~   "
130101|NCT01864447|"~     Patients after an acute blood clot in the veins are at risk for leg-related complications~     such as pain, swelling, and immobility. In addition, the occurrence of blood clots can have~     major implications for personal health including weight gain, blood clot recurrence and~     impairment in cardiovascular functioning. The goal of this study is to determine whether~     aerobic exercise training is a therapeutic strategy to offset risk factors for recurrent~     blood clots or leg complications.~   "
130102|NCT01864434|"~     This study will compare the kinematics data collected from patients with implants created by~     different manufacturers to see which of these implants provides a more normal-like kinematic~     pattern compared to the normal knee.~   "
130103|NCT01864421|"~     This is an observational study to see if at birth, flow of blood from a placenta to the baby~     can be estimated non-invasively using Doppler ultrasound and/or cutaneous perfusion measured~     using a novel PPG sensor.~   "
130104|NCT01864408|"~     The primary aim is to assess whether an interactive patient/provider counseling process using~     a web-based tool (iPadTM) will improve patient satisfaction regarding understanding of her~     bulge symptoms.~      The secondary aims are to assess whether an interactive patient/provider counseling process~     using web-based tool (iPadTM) will:~        1. Decrease patient anxiety with counseling~        2. Improve patient satisfaction with counseling~        3. Improve provider knowledge, anxiety, and satisfaction with counseling~        4. Be easy to use in clinic~        5. Be actually used in clinic~   "
130105|NCT01864395|"~     It is hypothesized that on-line modified ultrafiltration (MUFF) post-cardiopulmonary bypass~     will result in improved patient outcomes over the 12-hour post-operative period as compared~     to control and off-line MUFF.~   "
130114|NCT01864278|"~     The registry will enroll patients with claudication or ischemic rest pain and an~     angiographically significant lesion in the superficial femoral or popliteal artery. Subjects~     will be treated with the LUTONIX Drug Coated PTA Dilatation Catheter carrying the CE Mark per~     current Instructions for Use(IFU) and followed clinically for a minimum of 2 years.~   "
130115|NCT01864265|"~     By using functional MRI the investigators have recently shown that TNFi elicit rapid changes~     in brain function linked to the perception of RA [5]. Functional MRI represents a method~     allowing detecting tiny changes in neuronal activity by measuring alterations of blood flow~     in the context of neuronal activation. TNFi rapidly reversed the widespread activation of~     brain centers involved in pain such as the thalamus and the somatosensoric cortex, as well as~     those involved in the control, of mood and emotions such as the limbic system. Moreover, as~     small phase I study with 10 patients with RA showed that high brain activity detected in the~     functional MRI predicts clinical response to Certolizumab Pegol after 1 month, suggesting the~     central nervous system activity may be used as a tool to predict response to TNFi [8]. The~     rationale of this study is to test whether response to TNFi can be predicted by using~     functional MRI.~   "
130106|NCT01864382|"~     The stroke as cerebrovascular disease is the leading cause of permanent neurological~     disability and the third death in the Western world. Their affected often have motor and~     sensory disturbances in the form of hemiparesis with a possible influence on the balance be~     altered trunk muscles, important components of postural control. The treatment of stroke,~     covers a wide range of different strategies and approaches physiotherapy, including, specific~     exercises on the trunk called core stability, performed by the patient with the help and~     supervision of a physiotherapist specializing in neurology, that are based on coordination,~     motor and proprioceptive work, especially the lumbar-pelvic. The effectiveness of these last~     years has been demonstrated empirically, but until now there is no sufficient evidence of the~     effects of these exercises on sitting balance in respect, and standing up in the subacute~     phase post-stroke patients. To prove the evidence raises a randomized, multicenter, blinded~     and where the evaluator will not participate in the analysis and processing is done by~     intention to treat. Patients will be divided into two groups: control (usual physiotherapy~     center made ) and experimental (made also 15 minutes workout core stability). The~     intervention will have a frequency of 5 days a week for 5 weeks and up to 12 weeks. The~     expected effect is that the experimental group patients develop better postural control at~     the trunk and this influences the balance in sitting, standing and walking.~   "
130107|NCT01864369|"~     Chronic Heart Failure (CHF) is a growing public health issue in Canada. Hospital re-admission~     within 1-year after diagnosis is 25-40%, and the 5-year rate of CHF death is 50%. Counseling~     by multidisciplinary health care teams helps CHF patients to improve self-care behaviors (for~     medications, diet, exercise, smoking cessation and symptom monitoring), and this reduces the~     rate of death and CHF hospitalization. In the absence of intervention, patient adherence to~     these behaviors is below recommended standards and quality of life among CHF patients becomes~     progressively compromised. A major challenge is to make self-care counseling available~     without overtaxing health care resources.~      This 3.5 year multicenter clinical trial will establish and evaluate a Canadian e-platform~     that provides multidisciplinary e-counseling to help patients with CHF to initiate and~     maintain recommended self-care behaviors. The investigators will recruit 298 CHF patients in~     Toronto, Montreal and Vancouver. The investigators hypothesize that a 12-month program of~     e-Counseling + Usual Care versus general eInfo + Usual Care will improve quality of life,~     self-care behaviors and heart health. This proposal is based upon previous clinical trials in~     CHF, e-health and preventive lifestyle counseling by our team. It also builds upon our~     established collaboration with the consumer eHealth program of the Heart and Stroke~     Foundation of Ontario. The novel contribution of this research is that it will establish an~     infrastructure for a pan-Canadian e-platform in preventive e-counseling for CHF. A key~     feature of this proposal is that our multidisciplinary team will work with the Heart and~     Stroke Foundation to share our findings and e-health resources with the public and other~     health care professionals in Canada, which will help to galvanize research and clinical work~     in eCounseling. Our clinical trial will strengthen eCounseling services in order to improve~     the quality of life of patients with CHF.~   "
130108|NCT01864356|"~     The purpose of this study is to evaluate the efficacy, safety and tolerability of multiple~     doses of subcutaneous NT100 vs placebo following in vitro fertilization (IVF) in women with a~     history of repeated IVF failures.~   "
130109|NCT01864343|"~     The primary goal in the treatment of acute myocardial infarction is to reperfuse the ischemic~     myocardium to reduce infarct size. Animal data and human data suggest that whole-body cooling~     to temperatures below 35°C before revascularisation can additionally reduce infarct size and~     therefore improves outcome in these patients.~      The purpose of the study is to determine the feasibility and safety of a combined cooling~     strategy started in the out-of-hospital arena for achieving pre-reperfusion hypothermia in~     patients with acute st-elevation myocardial infarction.~   "
130110|NCT01864330|"~     Dry eye syndrome is a highly prevalent ocular disease with an increasing incidence in the~     elderly population. Topically administered lubricants are the basis for treatment of this~     disease. However, information about the corneal residence time of topical lubricants is still~     sparse, therefore no ideal treatment regimen has been found.~      Recently a new method for assessment of tear film thickness based on optical coherence~     tomography (OCT) has become available. The aim of the present study is to assess corneal~     residence time of three different formulations of topical lubricants, in particular Thealoz~     Duo® Eye Drops, Hyabak® Eye Drops and Hydrabak® Eye Drops in patients with moderate dry eye~     disease. In addition, standard tests for dry eye syndrome, such as the ocular surface disease~     index (OSDI©), Schirmer I test and determination of tear break up time (BUT) will be~     performed..~   "
130111|NCT01864317|"~     Glaucoma is among the leading causes for blindness in the western world. Elevated intraocular~     pressure (IOP) has been identified as the most important risk factor. However, some patients~     progress despite adequate IOP lowering while some subjects with elevated IOP never develop~     glaucoma. Other patients develop glaucoma although IOP measurements were always in the normal~     range. Therefore, other factors must be involved. In the last years, studies using MRI have~     been performed and evidence has accumulated that also changes in retrobulbar structures are~     present, in particular in the lateral geniculate nucleus and the visual cortex. However,~     these studies were limited by the low spatial resolution of the MRI instruments used.~      The investigators propose to overcome this problem by using an ultrahigh-field Magnetom 7T~     whole-body MR scanner (Siemens Medical, Germany) installed at the MR Centre of Excellence at~     the Medical University of Vienna. This scanner is equipped with a 32-channel head coil and~     the SC72 high-performance gradient system and is thus perfectly suited for structural and~     functional imaging. The aim of the present study is to investigate whether structural and~     functional parameters are altered in patients with primary open angle glaucoma (POAG), normal~     tension glaucoma (NTG), ocular hypertension (OHT) compared to healthy control subjects. The~     exact topographical survey of intracranial structures such as the LGN and the assessment of~     neuronal structures by DTI may allow for the better assessment of therapeutic responses to~     new neuroprotective agents.~   "
130112|NCT01864304|"~     Williams Syndrome (WS) is a genetic syndrome with features that may include vascular~     stenoses, neuro-developmental changes, and a variety of endocrine and metabolic~     abnormalities, including impaired glucose metabolism and abnormal body composition.~     Approximately 75% of adults with WS have impaired glucose tolerance or diabetes on oral~     glucose tolerance testing (OGTT). In addition, clinical observations and preliminary data~     suggest increased overall body fat in these individuals, as well as a relative increase in~     fat deposition in the lower extremities. However, glucose and lipid metabolism in WS remain~     incompletely characterized. The purpose of the current study is to carefully describe glucose~     metabolism and lipid parameters in people with WS.~   "
130113|NCT01864291|"~     The purpose of this research study is to determine whether Auditory Brainstem Implant (ABI)~     can improve hearing in children who are deaf and cannot receive a cochlear implants.~   "
130120|NCT01864200|"~     This study will evaluate the recovery from copperhead snake bite in patients with mild or~     moderate venom effect. Potential subjects received CroFab antivenom or placebo. After blinded~     treatment and discharge, the subject returns to the clinic for follow-up assessments at day~     3, 7, 14, and 28 after snake bite as well as follow-up telephone assessments on day 10, 17,~     and 24 after snake bite. The purpose of this study is to compare recovery in copperhead snake~     bite patients treated with antivenom vs placebo (no active drug) as measured by the Patient~     Specific Functional Scale (PSFS) at Day 14 follow-up. The primary efficacy endpoint of this~     study was achieved.~   "
130121|NCT01864187|"~     Dexmedetomidine hydrochloride ,a relatively new drug in Chinais ,is a highly selective,~     potent a2-adrenoceptor agonist with significant analgesic, sedative and anxiolytic effects.~     The morbid obesity in Chinese population is rapidly increasing. But the pharmacokinetics of~     the drug in these people is still unknown.This research was designed to study the~     pharmacokinetics of dexmedetomidine in Chinese morbidly obese population.~   "
130122|NCT01864174|"~     The purpose of this study is determine if Metformin XR monotherapy in subjects with type 2~     diabetes is non-inferior to Metformin IR monotherapy~   "
130123|NCT01864161|"~     Anemia is a common complication in patients with chronic kidney disease (CKD). In addition to~     erythropoietin deficiency, many studies have identified iron deficiency as a cause of anemia~     in CKD patients. Most patients with CKD are iron deficient because of: inadequate intake and~     absorption, gastroenteric bleeding, urinary iron loss in patient with significant~     proteinuria. The iron treatment is pivotal to manage anemic patients with CKD: the~     prescription of iron is usually oral because of practicality and safety, but often it is~     inevitable to administer intravenous iron because of gastroenteric malabsorption, intolerance~     to oral administration, irregular intake. There're few randomized controlled studies about~     the efficacy of oral iron versus intravenous iron in patients not on dialysis; most of them~     demonstrate superiority of intravenous therapy to restore iron deficiency and hemoglobin~     levels. A particular formulation of iron, liposomal iron has a high gastroenteric absorption~     and high bioavailability with lower incidence of side effects. The investigators study aims~     to evaluate the efficacy of treatment with liposomal oral iron compared to intravenous iron~     in CKD anemic patients not on dialysis in the presence of iron deficiency.~   "
130124|NCT01864148|"~     The primary objective of the study is to evaluate the efficacy of BIIB033 in participants~     with active relapsing multiple sclerosis (MS) when used concurrently with Avonex.~      Secondary objectives of this study in this study population are to assess the safety,~     tolerability, and population pharmacokinetics of BIIB033 when used concurrently with Avonex.~   "
130125|NCT01864135|"~     Prostate cancer has been the most common cancer in men in Finland over the last ten years.~     Prostate-specific antigen (PSA) plays an important role in screening of prostate cancer.~     However, PSA has a limited sensitivity and specificity for prostate cancer detection.~     Commonly, the diagnosis of prostate cancer is done by transrectal ultrasonography (TRUS)~     guided biopsy. Due to the low accuracy of TRUS, a systematic biopsy is usually performed~     instead of targeted TRUS biopsy. As biopsy carries a risk of increase in complications, there~     is an increasing interest in developing more accurate non-invasive imaging modalities.~      This study will enroll 150 men with clinical suspicion of prostate cancer due to higher serum~     level of PSA than 2.5 ng/ml and/or abnormal digital rectal examination. Multiparametric~     magnetic resonance imaging (mpMRI) at 3 Tesla (T) magnetic field using surface coils will be~     used to non-invasively predict the presence or absence of prostate cancer. Targeted TRUS~     guided biopsy based on MRI findings will be performed in addition to routine twelve core TRUS~     biopsy. Moreover, selected serum and urine biomarkers as well as biomarkers extracted from~     fresh biopsy sample will be collected and correlated with the presence or absence of prostate~     cancer.~   "
130126|NCT01864122|"~     The overall objective of this research proposal is to determine whether the predictive value~     of using plasma concentrations of selected nutrient biomarkers of food intake determined~     using a single plasma sample either alone or in combination are stronger, objective~     predictors of subsequent death from coronary heart disease (CHD) or myocardial infarct (MI)~     compared to selected food intake data derived from subjective, self-reported food frequency~     questionnaires.~   "
130127|NCT01864109|"~     The purpose of this study is to find out what effects, good and/or bad, the combination of~     irinotecan and temozolomide has on Ewing sarcoma.~      Irinotecan and temozolomide are chemotherapy drugs that are used very often to treat~     pediatric patients at MSKCC. The investigators have used these two drugs for many years to~     treat patients with Ewing sarcoma whose cancer has relapsed.~      For patients with newly diagnosed Ewing sarcoma the current standard of care at MSKCC is a~     five drug chemotherapy regimen in combination with surgery and/or radiation therapy. This~     standard regimen is called the EFT regimen. . Some patients with Ewing sarcoma do not have~     their cancer cured by the chemotherapy and surgery/radiation therapy.~      This study adds the chemotherapy drugs called irinotecan and temozolomide to the standard EFT~     regimen. The investigators are trying to improve the success of standard therapy by adding~     these drugs. The use of irinotecan and temozolomide in this study is experimental because~     they have not been used before in patients with newly diagnosed Ewing sarcoma. However the~     investigators have found these drugs to be effective in patients with relapsed Ewing sarcoma.~     It is not known if adding these two drugs will improve the outcomes of patients treated for~     Ewing sarcoma.~   "
130128|NCT01864096|"~     This study aims to see if metformin can delay the time to progression in men with low risk~     prostate cancer when compared to a placebo.~   "
130129|NCT01864083|"~     This study has been designed to help us determine if FACBC PET or PEM can accurately evaluate~     how far the breast cancer has spread in the breast. Also, to help determine if FACBC PET or~     PEM can accurately measure your response to chemotherapy.~   "
130150|NCT01863810|"~     Diabetic neuropathy is known to be the most common complication of diabetes, although the~     estimated prevalence is highly variable, ranging from 1.6 to 90%. Also, chronic pain is~     accompanied with sleep disorders, depression, and anxiety, thereby impairing quality of life~     and increasing societal costs. Pregabalin is one of proven and marketed oral medicine to~     manage the chronic neuropathic pain in diabetic patients. This study is designed as a~     randomized controlled trial to demonstrate that the efficacy of KW21052 in pain reduction~     measured by the weekly mean pain score on the numerical pain rating scale (NRS) at the 8th~     week of intervention is inferior to that of Lyrica.~   "
130130|NCT01864070|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of everolimus with TheraSphere that can be given to patients with advanced NETs~     that have spread to the liver. The safety of everolimus and TheraSphere will also be studied.~      Everolimus is designed to block a protein inside the cancer cells, which is also involved in~     cancer growth.~      TheraSphere is a medical device containing a radioactive material called yttrium-90 (Y-90).~     Tiny glass beads called microspheres are filled with Y-90 and then injected through an artery~     directly into the liver. This allows a large dose of radiation to be given directly to the~     tumor, which may lower the risk of side effects from the radiation to other parts of the body~     and/or to healthy liver tissue. The radiation from TheraSphere stays in the body and begins~     to lose its effect within 12 days. The glass microspheres will stay in the body from that~     point on. The radiation will eventually decay (go away). By the time a participant leaves the~     hospital, the amount of radiation outside of the body will be low enough to not be a threat~     to others.~   "
130131|NCT01864057|"~     Thiamine deficiency causes beriberi and is common in parts of rural Cambodia, where it~     appears to be a leading cause of infant death. The change in maternal and infant thiamine~     level after administration of thiamine to either Cambodian mothers or their infants is~     unknown. Normal human breast milk thiamine levels in thiamine-replete mothers are poorly~     characterized. The aim of this study is to determine if thiamine administered to nursing~     Cambodian mothers normalizes maternal and infant thiamine levels. Levels will also be~     obtained in nursing Caucasian mothers residing in the United States.~   "
130132|NCT01864044|"~     The aim of this observational study was to describe usual practices in lymphedema management~     in France.~      It was the opportunity to assess the effects of these practices on lymphedema volume in a~     large number of patients, to identify predictive factors of response, and to assess the~     safety of this therapy.~   "
130133|NCT01864031|"~     The association between alcohol consumption and cardiovascular disease (CVD) has mostly been~     examined using broad endpoints or cause-specific mortality. The purpose of our study is to~     compare the effect of alcohol consumption in the aetiology of a range of cardiovascular~     disease phenotypes.~   "
130134|NCT01864018|"~     This phase I/II trial studies the side effects and the best dose of cyclophosphamide when~     given together with ixazomib citrate and dexamethasone in treating patients with previously~     untreated symptomatic multiple myeloma or light chain amyloidosis. Drugs used in~     chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the~     growth of cancer cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Ixazomib citrate may stop the growth of cancer cells by~     blocking some of the enzymes needed for cell growth. Giving cyclophosphamide together with~     ixazomib citrate and dexamethasone may be a better treatment for multiple myeloma or light~     chain amyloidosis.~   "
130135|NCT01864005|"~     The purpose of this study is to test the hypothesis that the onset of the antiplatelet effect~     of ticagrelor is more rapid and greater than clopidogrel in Chinese patients with ACS.~   "
130136|NCT01863992|"~     The investigators wish to learn about the quality of life (QOL) of children needing long term~     home ventilation and also that of their regular caregivers. In addition, the investigators~     will monitor the extra health-related expenses these families must meet. Data will be~     collected using two age-specific questionnaires of QOL plus a third one validated for~     assessing chronic health care costs. Questionnaires will be administered at an initial face~     to face meeting, supplemented by two telephone follow-up calls, to monitor medical expenses,~     one and two months later.~   "
130137|NCT01863979|"~     Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and its prevalence~     increases with aging of the population. It is reflected in the ECG recording by the~     replacement of regular P-waves by an undulating baseline and irregular ventricular complexes~     [2]. The uncoordinated atrial activity prevents effective atrial contraction, leading to clot~     formation. Atrial fibrillation contributes significantly to population morbidity and~     mortality, and presently available therapeutic approaches have major limitations, including~     limited efficacy and potentially serious side effects. It can be classified into one of the~     three following categories:~        1. Paroxysmal: self-termination within 7 days~        2. Persistent: requires termination by pharmacological or direct-current electric~          cardioversion~        3. Permanent: restoration to sinus rhythm is impossible or inadvisable~      It is believed that in many cases the natural history of AF involves evolution from~     paroxysmal to persistent to permanent forms through the influence of atrial remodeling caused~     by the arrhythmia itself and/or progression of underlying heart disease. As many underlying~     conditions contribute to the development and progression of AF, the full and exact mechanisms~     standing behind this common arrhythmia are not completely or sufficiently understood.~      Thromboembolism is by far the most important complication of AF, and the most common factor~     in stroke in the elderly. The determinants of Virchow triad, including stasis, endothelial~     damage, and coagulation properties, are centrally involved in AF- related thrombus formation.~      Hence, thorough searching for new possible causes or contributing factors for the developing~     and progression of AF and its most threatening complication, thromboembolism, is mandatory~      The aim of the study is to look for new possible causes of atrial fibrillation and its~     complications.~   "
130138|NCT01863966|"~     From clinical observation that some achalasia patients drink water to help swallow food, the~     investigators have proposed a systemic hot water drinking therapy. This study is to observe~     its efficacy on achalasia symptoms and explore its mechanism.~   "
130139|NCT01863953|"~     This is a safety and efficacy study of fixed-combination bimatoprost and brimonidine compared~     with LUMIGAN® and ALPHAGAN® in patients with chronic glaucoma or ocular hypertension.~   "
130151|NCT01863797|"~     The purpose of the study was to compare early induction versus expectant management regarding~     outcome and experience of delivery in nulliparous women with a prolonged latent phase.~   "
130152|NCT01863784|"~     The purpose of this study is to characterize the pharmacokinetics (what the body does to the~     study medication) of JNJ-38518168 at approximately steady-state (stable medication levels)~     after administration of multiple oral 30 mg doses of JNJ-38518168 to participants with mild~     or moderate hepatic (liver) impairment (abnormal function) compared with participants with~     normal hepatic function.~   "
130153|NCT01863771|"~     The purpose of this study is to evaluate safety and effectiveness of golimumab in Japanese~     participants with moderately to severely active ulcerative colitis.~   "
130154|NCT01863758|"~     To compare the number of breakthrough bleeds under tailored prophylaxis with Human cell line~     recombinant factor FVIII (Human-cl rhFVIII) with the historical bleeding rate from patients~     who received Human-cl rhFVIII as on demand treatment.~   "
130155|NCT01863745|"~     The purpose of this study is to collect and assess long-term safety of nilotinib in patients~     who are on nilotinib treatment in a Novartis-sponsored, Oncology CD&MA study and are~     benefiting from the treatment as judged by the investigator.~   "
130140|NCT01863940|"~     Ukraine is a newly sovereign country in Eastern Europe with a large burn population. With the~     collapse of the Soviet Union, burn programs have become decentralized and resources for~     maintaining facilities have dwindled. Patients frequently present with debilitating burn~     injuries and often do not receive necessary treatment secondary to limited resources and cost~     of treatment.~      The investigators have established an annual medical mission, outreach clinic and~     telemedicine relationship with hospitals and burn centers in Ukraine in an effort to improve~     burn care. One focus is post-operative pain control. The investigators have noticed a pattern~     of anxiety with children from the Ukraine surrounding dressing changes which they believe~     this is secondary to inadequate pain control in the immediate post-operative period including~     the initial dressing changes.~      The goal is to provide wound catheters with a continuous infusion of procaine in an attempt~     to reduce the pain experienced in the early post-operative period and specifically with~     dressing changes.~      There will be 200 participants, 12-65 years old who are receiving reconstructive plastic~     procedure with split-thickness skin grafts from lateral thigh in the study. 100 will receive~     the standard pain management Analgin/Metamizole 1 g IM; Ketorolac 3%- 30 mg IM regimen and~     100 will receive wound catheters with continuous procaine infusion for 48 hours with the~     standard Analgin/Metamizole 1 g IM; Ketorolac 3%- 30 mg IM available for breakthrough pain.~     Pain scores will be assessed prior to dressing change, during dressing changes and at 30~     minutes and 1 hour after dressing change.~   "
130141|NCT01863927|"~     The purpose of this preliminary experiment is to measure the effect of a novel ventilation~     system on the physiological strain during exercise in high heat load while wearing ballistic~     protective vest. Ten young and healthy participants will participate in the study. They will~     all go through a six days heat acclimation period in a heat chamber according to a valid~     protocol. Afterwards they will be randomly exposed to 4 conditions during four separate~     consecutive days.~   "
130142|NCT01863914|"~     Background Arteriovenous (AV) fistula is the most common vascular access for long-term~     hemodialysis in the end-stage renal disease (ESRD) patients. About 25% of these patients are~     diabetes mellitus. However, the effects of hyperglycemia on the vascular function of~     arteriovenous fistula are still remained unclear. Studies have shown that blood flow in the~     AV fistula is significantly reduced in patients with diabetes mellitus. Diabetic patients~     also require a longer period of time for the maturation of AV fistula, and have slightly~     higher complication rate than non-diabetic patients. Statins have been widely shown to~     mediate several important pleiotropic effects in the improvement of vascular endothelial~     dysfunction, attenuation of inflammatory responses, stabilization of atherosclerotic plaques,~     inhibition of vascular smooth muscle proliferation, and modulation of procoagulant activity~     and platelet function.Our experimental studies in diabetic animals demonstrate that~     administration of a water-soluble statin rosuvastatin significantly improves the fistula~     flow, vascular function and luminal dilatation of AV fistula in diabetic rats by suppression~     of vascular oxidative stress and inflammatory load.~      Study hypothesis The central hypothesis of this research project is rosuvastatin mediates~     pleiotropic protective effect on vascular endothelial function and suppresses the regional~     pro-inflammatory reaction in the vasculature, therefore administration of rosuvastatin during~     the perioperative period of creation of native AV fistulas in diabetic patients with ESRD may~     potentiate the vascular function and reduce the primary failure rate of AV fistulae.~   "
130143|NCT01863901|"~     A proof of concept study to evaluate the feasibility of safe and effective treatment of upper~     limb spasticity using the Cryo-Touch III Device.~   "
130144|NCT01863888|"~     Primary Objective:~      To measure the effect of Teriflunomide on lymphocytes subsets in patients with relapsing~     forms of multiple sclerosis as compared with baseline values and those of a reference~     population of untreated healthy subjects.~      Secondary Objectives:~      To assess if Teriflunomide treatment results in biased T cell clonal diversity. To assess the~     effect of Teriflunomide on the function of peripheral blood mononuclear cells (proliferation~     and cytokine production in situ).~      To assess the circulating cytokines profile in the serum of Relapsing Multiple Sclerosis~     (RMS) patients during a 24-week treatment versus baseline and healthy controls.~      To assess the reversibility of all parameter changes in patients who discontinue treatment~     after accelerated elimination procedure with cholestyramine or activated charcoal.~   "
130145|NCT01863875|"~     Treatment with cochlear implantation is now offered to proximately 95 % of children with~     deafness in Norway. More than 500 children have been operated at Oslo University Hospital.~     The study is a cross-sectional study aimed to investigate speech perception, language skills,~     quality of life in all childhood cochlear implant (CI) recipients in Norway from 1988-2012.~     Factors such as child characteristics, characteristics with the family, the cochlear implant,~     the rehabilitation situation, choice of communication mode, school and work situation are~     surveyed to see if these factors can be associated with variations in outcome. The study will~     include pre and post lingual deaf children and children with multiple disabilities.~     Participants are recruited and examined in conjunction with their annual CI control at the~     hospital. It will be conducted a series of tests determining listening, speech and language~     development, non-verbal intelligence. Questionnaires are used to collect background~     information and quality of life experience. The questionnaires include self-report forms for~     different age groups, and a parent report form. The patient will be tested for the most~     common genetic causes of deafness. Additional data will be collected from patient records and~     from local health register at Oslo University Hospital.~   "
130146|NCT01863862|"~     In elderly patients postoperative mortality measured 3-6 months after total mesorectal~     excision is high. Thus, less toxic treatments may lead to a survival benefit for elderly~     patients even if a risk of local recurrence is slightly higher compared to the open surgery.~     The investigators addressed the question whether watch and wait policy is safe in clinical~     complete responders after (chemo)radiation for elderly patients with small or moderately~     advanced tumours.~   "
130147|NCT01863849|"~     To assess immunogenicity of a single intramuscular injection of Fluval AB suspension for~     injection (trivalent, seasonal influenza vaccine, active ingredient content: 15 μgHA/0.5mL of~     seasonal A/H1N1, A/H3N2 and B influenza antigens each), as measured by haemagglutination~     inhibition (HI) test.~   "
130148|NCT01863836|"~     The purpose of this study is to determine whether the use of fluoroscopy improves the~     diagnostic yield of peripheral pulmonary lesions' biopsy guided by radial endobronchial~     ultrasound (with the use of a guide sheath).~   "
130157|NCT01863719|"~     Colistin is amphipathic, cannot be absorbed from the gastrointestinal tract and is~     administered intramuscularly, intravenously (IV) or via inhalation. In the case of pneumonia,~     aerosolized route of administration is favorable as it presumably delivers a high~     concentration of drug directly to the infection site. Colistimethate sodium is an FDA~     approved drug, however, its aerosolized use represents a new method of administration not~     currently FDA-approved in the United States. In this proposal, the inactive prodrug~     colistimethate sodium has been selected to use for aerosolization as it is better tolerated~     than colistin sulphate. It is a randomized, open-labeled Phase 1 trial of aerosolized and/or~     IV formulations of colistin as multiple doses over seven days. The primary objective of this~     trial is to evaluate the safety and tolerability of multiple doses of aerosolized and~     intravenous colistimethate sodium separately or in combination in healthy adult subjects.~   "
130158|NCT01863706|"~     Post partum Hemorrhage (PPH) is one of three main causes of death in pregnant women. Oxytocin~     is widely used for prevention of PPH. Some studies suggested misoprostol as an alternative~     treatment when Oxytocin isn't available. The aim of this study is to compare the safety and~     efficacy of Oxytocin and misoprostol for prevention of PPH.~   "
130159|NCT01863693|"~     This multicenter, prospective, observational study will evaluate the safety and efficacy of~     Avastin (bevacizumab) in combination with chemotherapy as first-line treatment in patients~     with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer in routine~     clinical practice. Eligible patients will be followed for approximately 15 months.~   "
130160|NCT01863680|"~     The primary objective of this trial is to demonstrate the non-inferiority of the clinical~     pregnancy rate per embryo transfer to the historical standard value in in-vitro fertilization~     (IVF)/embryo transfer (ET) cycles in Japan (Japan Society of Obstetrics and Gynecology [JSOG]~     2009 registry data: 24.3 percent [%]). The secondary objectives of this trial are to assess~     the biochemical pregnancy rate per ET, pharmacokinetics, and safety of COL-1620.~   "
130161|NCT01863667|"~     This trial will assess the safety and efficacy of omarigliptin (MK-3102) compared with the~     sulfonylurea, glimepiride, in type 2 diabetes mellitus participants who are metformin~     intolerant or who have a contraindication to the use of metformin. The primary hypothesis is~     that after 54 weeks, the mean change from baseline in hemoglobin A1c (A1C) in participants~     treated with omarigliptin is non-inferior compared with that in participants treated with~     glimepiride.~   "
130162|NCT01863654|"~     The objective of this study was to confirm if two formulations of montelukast tablets are~     bioequivalent.~      Test product was Montelukast (5 mg chewable tablets; GlaxoSmithKline) and reference product~     Singulair (5 mg chewable tablets; Merck Sharp & Dohme). The single dosage was one tablet.~      The study was prospective, open-label, randomized, crossover, single dose, with 02~     treatments, 02 sequences and 02 periods, under fasting conditions.~      The population was composed of 32 healthy volunteers, both genders, adults between 18-50~     years.~      The comparative bioavailability of the two formulations was evaluated based in statistical~     comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations~     in blood.~   "
130163|NCT01863641|"~     The purpose of this study is to determine whether calcitriol is effective in the treatment of~     lupus nephritis.~   "
130164|NCT01863628|"~     Background and study hypothesis:~      Many studies including prospective studies have been demonstrated that a long symptomatic~     prodromal phase exists prior to the onset of full-brown bipolar disorder, lasting for 9-12~     years (Egeland et al., 2000). During the prodromal stage, there are three main clusters of~     syndromes, including hypomania/mania symptoms, depressive symptoms, and signs of attention~     deficit hyperactivity disorders (Correll et al., 2007; Tillman et al., 2003; Mantere et al.,~     2008). Of the hypomania/mania symptoms, decreased sleep, elevated mood, irritability, mood~     lability, increased energy, and psychomotor agitation are present most frequently. The~     prodromal depressive symptoms are reported to be depressed mood, anhedonia, insomnia,~     feelings of worthlessness. Among patients with bipolar disorders, 22.5% reported to comorbid~     with pediatric ADHD. In addition, some symptoms are considered as non-specific such as~     decreased functioning, anger outburst, social isolation, and anxiety (Egeland et al., 2000).~      Offspring of parents with bipolar disorders are much likely to present prodromal symptoms~     compared to offspring of healthy parents. In a 10-year longitudinal study using 55 prodromal~     symptoms checklist, , Egeland et al.(2002) found that 38% offspring of parents with bipolar~     disorder were considered as at risk compared to 17% in children of healthy parents. In a~     15-year follow-up study, Duffy et al.,(2009) found that 32.7% offspring (aged 8-25 years old)~     of parents with bipolar disorder met the criteria of major mood episode.~      Objectives:~      One primary objective of this study is to prospectively identify the prodromal stage of~     bipolar disorder.~      Another primary objective is to conduct a randomized, place-controlled trial of aerobic~     exercise on people who suffering from prodromal symptoms to the extent of significantly~     impaired function, with attempt at delaying or preventing the onset of a full-blown bipolar~     disorder.~      Design of study and the procedures:~      The study will consist of two phases: one-week screening period and a randomized,~     placebo-controlled, 3-month trial. During the screening period, offspring of parents with~     bipolar disorder will undergo systematically clinical evaluations. The offspring will be~     evaluated with clinical symptoms assessing scales, neuropsychological tests, magnetic~     resonance imaging. During the 3-month trial period, the offspring who meet the inclusion~     criteria will be randomly assigned to receive treatment of aerobic exercise, placebo, or~     wait-list group. Psychiatrists are scheduled to assess mood, treatment outcome during the~     3-month trial.~      Subjects and treatment It is expected that 120 offspring of parents with bipolar disorder~     aged between 10—25 years, meeting the inclusion of prodromal stage, will be included in the~     study. All of the offspring will undertake the Kiddie Sads Present and Lifetime Version~     (K-SADS-PL), and a 70 checklist items of potential prodromal symptoms suggest by us as well~     as by Dr. Correll et al. (2007). The parents of these offspring are to have a DSM-IV~     (Diagnostic and Statistical Manual of Mental Disorders)-defined bipolar disorder (bipolar I~     or II), confirmed by the Chinese version of Structured Clinical interview for DSM-IV-TR Axis~     I Disorders patient edition (SCID-I/P) [First et al., 2002]. The offspring are to be~     recruited through the referrals by their parents who will receive psychiatric services in the~     Guangzhou psychiatric Hospital.~      The offspring will be randomly assigned to aerobic exercise and placebo controlled groups.~     The aerobic exercise would include cycling, jogging,table tennis, and playing badminton for~     40 mins at least 3 times a week for 3 months. In each exercise, participants are supposed to~     exercise to the extent of getting sweaty. In the placebo group, participants will receive~     general psychoeducation, including delivering knowledge on symptoms, discussion of the~     suffering mental difficulties, and general coping techniques.~      Significance:~      Bipolar disorder is a common, chronic, and recurrent mental disorder. The recognition of~     prodromal stage of bipolar disorder and the early intervention on it may help delay or~     prevent the onset of bipolar disorder.~   "
130165|NCT01863615|"~     The objective of this study was to confirm if two formulations of isotretionin (capsules) are~     bioequivalent.~      Test product was Oratane® 20 mg (Laboratorios Dermatológicos Darier) and reference product~     Roaccutan® 20 mg (Productos Roche). Two capsules administered together were the single~     dosage.~      The study was prospective, open-label, randomized, crossover, single dose, with 02~     treatments, 02 sequences and 02 periods, under fed conditions.~      The population was composed of 36 healthy volunteers, male adults between 18-45 years.~      The comparative bioavailability of the two formulations was evaluated based in statistical~     comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations~     in blood.~   "
130166|NCT01863602|"~     The objectives of this post-marketing surveillance (PMS) are to grasp the actual use of~     lamotrigine tablets to collect safety information in the long-term use according to seizure~     type and concomitant antiepileptic drug (AED), and to confirm its efficacy.~   "
130167|NCT01863589|"~     This post-marketing surveillance (PMS) is conducted to collect safety and efficacy data among~     subjects with chronic hepatitis B and hepatic cirrhosis B who is treated with adefovir~     tablets.~   "
130168|NCT01863576|"~     The objective of this trial is to study the effects of omega-3 PUFA supplementation on the~     inflammatory response and lipid profile in patients with chronic Chagas cardiomyopathy.~      Study Type: Interventional~      Study Design: A total 40 patients will be randomly assigned into two parallel groups. The~     intervention will be treatment with omega-3 PUFAs at a dose of 3 g/day for 8 weeks, compared~     to placebo (corn oil). The primary endpoints will be the concentrations of inflammatory~     markers (IL-1, IL-2, IL-4, IL-6, IL-10, TNF-alpha, IFN-γ, and TGF-β). Secondary endpoints~     will be the fasting glucose, lipid, and anthropometric profiles.~   "
130169|NCT01863563|"~     Hemostasis will be achieved during Pediatric Tonsillectomy/Adenoidectomy with the use of~     QuickClot.~   "
130170|NCT01863550|"~     This randomized phase III trial studies bortezomib, lenalidomide, and dexamethasone to see~     how well they work compared to carfilzomib, lenalidomide, and dexamethasone in treating~     patients with newly diagnosed multiple myeloma. Bortezomib and carfilzomib may stop the~     growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide~     may help the immune system kill abnormal blood cells or cancer cells. Drugs used in~     chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. It is not yet known whether bortezomib, lenalidomide, and dexamethasone are more~     or less effective than carfilzomib, lenalidomide, and dexamethasone in treating patients with~     multiple myeloma~   "
130194|NCT01863238|"~     This study is designed to evaluate the risk of cataracts (lens opacities) and describe the~     best corrected distance vision (with glasses/contacts for those who wear them) of pediatric~     patients with Cystic Fibrosis who are 11 years of age or younger at the time of ivacaftor~     treatment initiation and are receiving or planning to receive commercially-available~     ivacaftor in the US.~   "
130171|NCT01863537|"~     This RCT will randomly assign 40 of the CBOs to receive the Multimedia intervention and~     training package (Multimedia)and the other 40 to receive the original, manualized Connect~     intervention and training package (Traditional). The technology transfer process involves all~     agencies receiving four days of training and two planned technical assistance conference~     calls, by study investigative staff, in the first four months following training. Telephone~     assessments completed by up to 6 staff at each agency will measure primary outcomes,~     mediating, moderating and process measure variables at baseline, 6, 12 and 18 months~     post-technology transfer. The primary outcome of the study is adoptions of the Connect~     intervention. The unit of analysis is the CBO.~   "
130172|NCT01863524|"~     The prevalence of Abdominal Aortic Aneurysm among 65 years old individuals worldwide is 1-2%.~     when diagnosis is confirmed by abdominal Ultrasound the prevalence is 5.5% in men and 1% in~     women.~      As abdominal aortic aneurysm and coronary heart disease share common risk factors, patients~     with acute coronary syndrome represent a high risk population in which screening for another~     atherosclerotic site is recommended.~      Patients admitted for ACS undergo routinely TTE. during the same study, TTE may offer the~     opportunity to evaluate the cardiac morphology and function and to screen for Abdominal~     Aortic aneurysm. It was reported by different studies that the Sensitivity of this technique~     was between 91-96% for AAA screening.~      In addition, this method is cheap, available and requires only 2-3 minutes to be added to the~     standard TTE.~      we plan to examine patients admitted with ACS in our Intensive Care Unit for screening AAA by~     TTE in subcostal views in addition to the standard TTE examination.~   "
130173|NCT01863511|"~     For patients hospitalized with acute decompensated heart failure,volume removal remains the~     primary therapeutic objective. The current standard of care remains loop diuretics.The high~     likelihood of readmissions and poor outcomes highlights the need to examine and improve~     in-hospital protocols for these patients. Ultrafiltration allows for greater volume removal,~     less neurohormonal stimulation and greater sodium removal.However it is associated with~     increased costs, line complications, and relative immobility during treatment. Tolvaptan in~     addition to diuretic therapy has been shown to improve the amount of volume removed compared~     to diuretic alone.~      The study proposes to compare the strategy of adding tolvaptan to usual care with~     ultrafiltration as primary mode of therapy in acute decompensated HF(ADHF) patients.~      Hypothesis: addition of tolvaptan to usual care for hospitalized HF patients will result in:~        -  greater volume and weight reduction compared with usual care~        -  similar efficacy outcomes compared with ultrafiltration, with less complications of~          therapy~   "
130174|NCT01863498|"~     Pectus excavatum, the most common chest wall deformity, occurs in roughly one in 1000~     children. Operative repair of the anterior thoracic concavity has transitioned to the~     minimally invasive approach with substernal bar placement through small axillary incisions~     (Nuss procedure and multiple modifications). These procedures were quickly incorporated by~     high volume centers around the world including our own. The operation is certainly quicker~     and associated with less blood loss than the open operation, but as opposed to most minimally~     invasive versions of an operation, patients do not leave the hospital sooner after bar~     placement and experience more post-operative pain.~      Pain during the post-operative hospital stay is the dominant management issue after bar~     placement. The sparse literature on the topic has suggested that a thoracic epidural is the~     most effective means for attenuating the pain during the first few post-operative days.~     Therefore, most centers approach all patients undergoing a pectus deformity repair with an~     attempt at epidural placement under the assumption that this provides the most effective~     strategy for pain control.~      However, the investigators conducted a retrospective evaluation to examine the validity of~     this assumption and to investigate whether there is a role for a prospective study to~     determine the optimum post-operative pain management of these patients. The results~     demonstrate there was a decreased length of stay in the patients not treated with an epidural~     (PCA), despite no disadvantage in pain control. Further, 30% in whom an epidural was~     attempted, catheter placement failed.~      This data certainly challenges the assumption that an epidural is the optimum management for~     these patients, and convincingly answers the question as to whether there is a role for a~     prospective randomized trial.~   "
130175|NCT01863485|"~     This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability, and~     Pharmacokinetics of CM082 tablets in Chinese Patients With Advanced Solid Tumors.~   "
130176|NCT01863472|"~     Aim of the study is to compare the safety and efficacy of pulmonary vein isolation using the~     endoscopic ablation system in comparison to irrigated radiofrequency current ablation in~     patients with drug-refractory persistent atrial fibrillation.~   "
130177|NCT01863459|"~     1. To evaluate the safety, and efficacy of Lisdexamfetamine dimesylate in the treatment of~          outpatients with DSM-IV ADHD with anxiety and depressive disorder comorbidity, as well~          as to evaluate the effects on quality of life .~        2. To evaluate the efficacy of Lisdexamfetamine dimesylate in the treatment of anxiety and~          depressive disorders which commonly occur with ADHD.~        3. To examine the potential relationship between telomere length and Adult ADHD with~          comorbidity and the potential effect of treatment response.~        4. To examine the potential associations with specific genes and Adult ADHD.~   "
130178|NCT01863446|"~     Specific Aim: Test the hypothesis that ocular light exposure will suppress melatonin~     secretion and reduce uterine contractions in women at late term pregnancies.~      Secondary aim. Test the hypothesis that ocular light exposure will reduce self-reported~     uterine contractions in women at late term pregnancies.~   "
130179|NCT01863433|"~     This is a study to assess the immune (antibody) response and safety of a bioCSL split virion,~     inactivated influenza vaccine containing the 2013/2014 formulation of Enzira® vaccine in~     healthy adult volunteers aged between 18 and 60 years.~   "
130192|NCT01863264|"~     The purpose of this study is to see if cold liquids improve the swallowing mechanisms in~     premature infants with swallowing difficulties (dysphagia). The only way to objectively~     diagnose dysphagia is by having that infant undergo a Video Fluoroscopic Swallow Study~     (VFSS), which allows direct visualization of the liquid bolus (barium) in real time. Infants~     suspected of having dysphagia and who are referred for a VFSS will be recruited for this~     study. Once consented, the infant will undergo a standard VFSS. If that infant is diagnosed~     with dysphagia, the study protocol will begin by keeping the infant the same position and~     feeding them cold liquid barium from an identical bottle. A total of 5 swallows will be~     visualized, which adds approximately 5-10 seconds to the study. Both the standard swallows~     and the study swallows will be recorded for analysis and comparison. It is hypothesized that~     the study swallows will have less deficits than the standard swallows. If an infant's~     standard VFSS does not indicate dysphagia, that infant will no longer be eligible for this~     study.~   "
130193|NCT01863251|"~     To evaluate the tolerability, acceptability and potential effect size of the efficacy of 4~     months of atomoxetine treatment for patients with co-occurring ATS and heroin dependence~     (COATS) receiving buprenorphine maintenance treatment (BMT) and educational drug and HIV risk~     reduction counseling (EDRC).~   "
130180|NCT01863420|"~     Concurrent chemotherapy with external beam radiotherapy is the standard treatment of bulky or~     locally advanced cervical cancer, gastric cancer and rectal cancer.Despite excellent~     therapeutic results, acute hematologic toxicity (HT) is common with this regimen. Previous~     studies have founded acute HT was significantly associated the volume of pelvic (PBM) and~     lumbosacral bone marrow (LSBM) receiving 10 and 20 Gy radiation (RT). Therefore, reducing the~     volume of BM receiving low-dose RT might prevent HT.~      More than one-half of the body's bone marrow (BM) is located in the PBM, LSBM and proximal,~     where is just in the low dose of RT in patients with gastric, rectal and cervical cancer.~     Previous study have demonstrated highly conformal IMRT treatment plans reduced the volume of~     PBM irradiated resulting in less HT. We have since assumed that even better BM sparing is~     possible when the BM is entered as a separate constraint in the planning process. However, it~     is well known that hematopoietically active (red) BM is poorly visualized with computed~     tomography (CT). Consequently, the entire contents of the medullary canals must be entered as~     BM. Yet, a considerable portion of the medullary canal is comprised of inactive (yellow)~     marrow, which is composed primarily of fat. Contouring the entire medullary canals on CT thus~     overestimates the volume of active BM, unnecessarily constraining the IMRT plan. An~     alternative approach is the incorporation of functional BM imaging into the treatment~     planning process. One economical and efficiency approach involves the use of T1-weighted~     magnetic resonance (MR) images.~      Therefore, we designed this study to test whether a separate constraint of active BM~     identified by MR could reduce acute HT in course of concurrent chemoradiotherapy for patients~     with gastric and rectal cancer.~   "
130181|NCT01863407|"~     This study is being conducted to determine whether Dexamethasone-Allantoin-Metronidazole~     (DAM) Solution can accelerate recovery of gastrointestinal function following abdominal~     operation when compared with a placebo.~   "
130182|NCT01863394|"~     The objective of this study is to determine the efficacity of a community strategy for~     screening children 06-59 months old for Severe Acute Malnutrition (SAM) conducted by their~     mothers' compared with a community screening strategy conducted by Community Health Workers.~   "
130183|NCT01863381|"~     This research is being done to determine the accuracy of two noninvasive methods of measuring~     the pressure of the cerebrospinal fluid (CSF), also known as intracranial pressure or ICP.~   "
130184|NCT01863368|"~     The purpose of this study is to compare Systane® ULTRA lubricant eye drops to OPTIVE®~     lubricating eye drops for ocular surface staining within dry eye subjects and to evaluate the~     safety of Systane® ULTRA after 3 months of use.~   "
130185|NCT01863355|"~     Fentanyl based intravenous patient controlled analgesia(PCA)is popular method for~     postoperative pain control, but information regarding optimal dose of fentanyl in IV PCA is~     currently lacking. We thus determine appropriate dose of fentanyl (bolus dose and background~     infusion rate) for effective pain control with minimal side effects such as nausea and~     vomiting~   "
130186|NCT01863342|"~     Nociceptor inputs can trigger a prolonged but reversible increase in the excitability and~     synaptic efficacy of neurons in central nociceptive pathways, the phenomenon of central~     sensitization. The degenerative joint disease, osteoarthritis, with characteristic~     destruction of cartilage and alteration in bone is a very common cause of chronic pain. The~     degree of pain does not always correlate with the extent of joint damage or presence of~     active inflammation raising the possibility that there may be a central component to the~     pain. The central sensitization inventory (CSI) is a new self-report screening instrument to~     measure the degree of central sensitization, and to help identify patients with central~     sensitivity syndromes. The aim of this investigation is to evaluate the influence of~     preoperative central sensitization, which represented by CSI score, on postoperative pain~     score in osteoarthritis patients undergoing total knee replacement who receiving~     patient-controlled epidural analgesia.~   "
130187|NCT01863329|"~     Studies in patients with intracranial hypertension have shown a good relationship between~     optic nerve sheath diameter measured by retrobulbar ultrasound and invasively measured~     intracranial pressure. The aim of this study was to evaluate changes in optic nerve sheath~     diameter before and after drainage of cerebrospinal fluid in patients with hydrocephalus.~   "
130188|NCT01863316|"~     Although the safety and efficacy of the I gel in children has been shown in several large~     observational studies, There is no study about comparison of the clinical efficacy between~     I-gel and LMA-Supreme , in particular sizes 1 and 1½. The pediatric i-gel and LMA Supreme are~     new supraglottic airway device for children. It is made of a soft, gel-like elastomer with a~     noninflatable cuff. Studies about I-gel and LMA Supreme in adults have been promising,~     showing an easy insertion, high airway leak pressures, and low complication rates with few~     postoperative complaints. The aim of this study is to compare clinical performance of the~     pediatric i-gel and LMA Supreme in infants.~   "
130189|NCT01863303|"~     The incidence risk of colorectal cancer （CRC） is increasing at 4.2% year by year in China.~     Most effective way to reduce the death rate of CRC patients is to diagnose in quite an early~     stage. QiaoKou District is a chemical industry Zone of Wuhan with a long history, which has~     few data of CRC epidemiology. The investigators design the primary CRC screening for this~     district by healthy questionnaire, Fecal Occult Blood Test(FOBT) and colonoscopy. HanYang~     Areo has been chosen as Control for its non-industry environment.The crowd would be screen~     biennially. The high risk group would be intervened, such as resection of polyps or other~     specific treatment. A follow-up registration database has been built for analysis the~     relationship between incidence or death rate to high risk factors, such as age, life~     environment, lifestyles, base diseases and family history of cancer.~      This study will provide some epidemiology dates of CRC to the local Government, and assist~     the governor to built a more effective screening system of CRC.~   "
130190|NCT01863290|"~     The Transitions Clinic Network (TCN)aims to connect former inmates to primary care using~     trained, culturally competent primary care providers and community health workers (CHWs). The~     purpose of this project is to support ongoing quality improvement at the 13 participating~     sites by training culturally competent CHWs and measuring the health, health care~     utilization, and the costs of caring for former inmates.~   "
130191|NCT01863277|"~     The purpose of the study is to evaluate the effect of Melatonin (in a dosage of 14mg daily)~     for a better clinical outcome in the period three days post stroke.~   "
130196|NCT01863212|"~     In order to investigate if individuals, carrying genetic variants predisposing to obesity,~     respond differently to visual presented food images than non-carriers the investigators aim~     to screen 500 people for a common risk variant in the FTO gene. From those 500 screened 40~     subjects, 20 homozygous for the risk allele and 20 homozygous for a non risk allele will be~     selected for the second step in the study. This part involves the fMRI technique to visualize~     the brain response, focus on reward system activation, when food images are visually~     presented in the scanner. Factors regarding eating behavior, sleep, physical exercise and~     relation to food are investigated in the first part of the study as well as clinical~     parameters such as BMI.~   "
130197|NCT01863199|"~     A study to use in home technology to reduce the burden of in office visits and injections.~   "
130198|NCT01863186|"~     The purpose of this study is to look at the efficacy and safety for lofexidine hydrochloride,~     an alpha-2 adrenergic agonist under development for the treatment of acute withdrawal from~     short-acting opioids. The study takes place in 2 parts: a 7-day inpatient double-blind~     treatment portion where subjects will be randomly assigned to one of three doses of study~     medication (2.4 mg total daily dose of lofexidine, 3.2 mg total daily dose of lofexidine, or~     placebo) followed by an optional open-label treatment period where subjects will be inpatient~     or outpatient and receive lofexidine at variable dosing for up to an additional 7 days. The~     Investigator hypothesizes that subjects will achieve maximum treatment effect with tolerable~     side effects at the 3.2 mg total daily dose and that both the 3.2 mg and 2.4 total daily~     doses will show better efficacy over placebo in treating symptoms of acute opioid withdrawal.~   "
130199|NCT01863173|"~     effect of B blocker was first evaluated in patient with cardiomyopathy not induced by~     ischemia and idiopathic which as the most common causes of cardiomyopathy. Effect of BB on~     Thalassemia cardiomyopathy was evaluated in this study~   "
130200|NCT01863160|"~     It is a phase I randomized, double blind, placebo-controlled, dose-escalating study to assess~     safety, tolerability and pharmacokinetics (PK) data of 0.1% and 1.0% ZEP-3 cream,~     administered topically up to 5 consecutive treatment days in healthy volunteers.~      This is a single center trial. It is anticipated that the study will be conducted at the~     Department of Dermatology, at the Sheba Medical Center, Ramat Gan, Israel.~      The screening/enrollment visit includes a PK study for 24h following a single IP topical~     application. After a 24h washout time break, the subject will enter the treatment period for~     5 consecutive treatment days followed by a follow up visit 1 and 5 days after end of~     treatment.~   "
130201|NCT01863147|"~     Cardiovascular complications account for the highest mortality in type 2 diabetic patients,~     mainly due to coronary artery disease (CAD).Left ventricular hypertrophy (LVH) is widespread~     in type 2 diabetic patients with CAD, even in the absence of hypertension .It is a strong~     predictor of cardiovascular events and all-cause mortality .~      Sitagliptin, an inhibitor of dipeptidyl peptidase-4 (DPP-4), may regress left ventricular~     mass (LVM) in newly diagnosed type 2 diabetic patients with CAD .~   "
130202|NCT01863134|"~     1. INTRODUCTION~           Through last couple of years the number of patients treated for acute coronary event~          without persistent ST segment elevation in ECG has been growing.~           This is probably an effect of improving diagnostics of myocardial infraction without~          persistent ST segment elevation in ECG, due to routine Troponin serum level evaluation~          and better primary prevention.~           This fact makes the search for the optimal treatment for patients with acute coronary~          event without persistent ST segment elevation in ECG, including both patients intended~          for pharmacological and invasive treatment percutaneous coronary intervention (PCI) or~          coronary artery byppass grafting (CABG).~           Patients undergoing invasive treatment for acute coronary event, have higher risk rate,~          than those with stabile angina pectoris.~           The authors of this study want to evaluate, whether the proportional use of platelet GP~          IIb/IIIa receptor antagonist - eptifibatide in patients undergoing CABG results in~          improvement of short-, and long time results in those patients.~           Eptifibatide ( Integrilin) a cyclic heptapeptide antagonist of the GP IIb/IIIa integrin~          receptor, is an intravenous antagonist with rapid onset and short half-life.~        2. STUDY RATIONALE~      The notion acute coronary syndrome (ACS) includes several clinical situations, such a~     unstable coronary artery disease, non-Q wave myocardial infarction and Q wave myocardial~     infarction.~      On the basis of 12-lead ECG, patients with acute coronary syndrome (ACS) can be divided into~     two groups: with and without ST segment elevation.~      Another stratification factor in patients with ACS, especially these without ST elevation is~     evaluation of biochemical markers of myocardial necrosis, such as Troponins (TnI, TnT) and~     creatinine kinase isoenzymes (CK-MB). Serum concentrations of these markers allow to~     distinguish myocardial infarction (elevation of markers' concentration) from unstable~     coronary artery disease.~      All ACS have common etiopathogenesis which is plaque rupture, thrombus formation in the lumen~     of coronary artery.~      Platelets are the key factor in this process. Platelets by means of their collagen and von~     Willebrand factor glycoprotein receptors bind to damaged artery wall. Simultaneously many~     factors cause platelet activation, which leads to changes in their shape, release of~     intraplatelet components and activation of fibrinogen-binding glycoprotein receptors IIb/IIIa~     (GP IIb/IIIa). Activated form of GP IIb/IIIa binds to GP IIb/IIIa of another platelet by~     means of fibrinogen molecule. Fibrinogen molecules form stable bridges between platelets.~     This process is referred to as aggregation, and leads to clot formation, which is further~     stabilized by fibrine fibres.~      In this way the intravascular thrombus is formed, which after totally occluding the arterial~     lumen causes acute ischemia of the relevant region of myocardium and subsequently its~     infarction.~      The key role of GP IIa/IIIb in the process of platelet clot formation has important~     therapeutic consequences. By now several specific (direct) and non-specific (indirect)~     antagonists of GP IIb/IIIa have been developed.~      There are indirect antagonists as acetylsalicylic acid, ticlopidine and clopidogrel and~     direct antagonists as abciximab, tirofiban and eptifibatide Additionally also anticoagulants~     (heparin, LMWH - low molecular weight heparin) have antiplatelet properties by inhibiting~     thrombin production.~      Clinical studies performed all over the world have proven the efficacy and safety of three~     agents from the GP Iia/IIIb group: abciximab, tirofiban and eptifibatide.~      In several big clinical studies (EPIC, EPILOG, EPISTENT, ESPRIT, CAPTURE, PURSUIT,~     PRISM-PLUS, TACTICS-TIMI 18) the high efficacy of these drugs was showed in patients with ACS~     without ST segment elevation undergoing mainly percutaneous transluminal coronary angiography~     (PTCA) and stenting. The use of GP IIa/IIIb antagonists in this group of patients~     significantly reduces the death and myocardial infarction (MI) rate during early as well as~     late follow-up period. Moreover, last observations indicate, that the biggest benefit from~     such therapeutic strategy is observed in high risk patients; those with diabetes, high~     troponin levels and ECG changes.~      During last years, there is an increase in frequency of ACS without ST segment elevation.~     This is probably due to improved diagnostics of MI without ST elevation basing on routine~     troponin evaluation, but also thanks to better primary prevention.~      Therefore determining an optimal therapeutic strategy for patients with ACS without ST~     segment elevation remains a crucial issue.~      It concerns patients qualified to medical treatment as well as those qualified to invasive~     procedures (PTCA or CABG).~   "
130203|NCT01863121|"~     The CTP score is one of the best proved severity score in predicting mortality in patients~     with cirrhosis. Portal hypertension and variceal bleed are significant causes of morbidity~     and mortality in patients with cirrhosis. The recently published CTPK score included variceal~     variceal bleed status to the CTP score which improved the accuracy of CTP score in predicting~     short term mortality. CTPK score needs prospective validation.~   "
130204|NCT01863108|"~     The primary objective of this study is to evaluate the safety and tolerability of multiple~     sub-cutaneous injections of GeniusVac-Mel4, a dendritic cell-based cancer vaccine, in~     patients with melanoma. The secondary objectives are to determine immune response and~     clinical efficacy of such injections in patients with melanoma.~   "
130205|NCT01863095|"~     Currently, marijuana (MJ) is the most popular illicit drug, but there are few effective~     interventions to help young adults (age 18 to 25 years) to reduce their MJ intake. In this~     study, we will develop and initially test a smart phone app designed to promote~     exercise/physical activity as a positive alternative to MJ use. The app will be tested in an~     efficacy study in which MJ users are randomly to either receive personalized feedback about~     MJ use + use the exercise app or personalized feedback only. The results will contribute to~     knowledge about exercise/physical activity as a strategy for reducing young adults' MJ use~     and problems.~   "
130206|NCT01863082|"~     patients with resistant hypertension will be submitted to an exercise protocol in a heated~     pool for three months~   "
130207|NCT01863069|"~     The primary objective was to determine the tolerability of a new inhaled formulation of~     interferon beta-1a when given as a single dose, when given once per week for 4 weeks, and~     compared with standard intramuscular (IM) AVONEX® when given as a single dose.~      The additional objectives were:~      To determine the pharmacokinetic (PK) properties of a new inhaled formulation of interferon~     beta-1a, using an anti-viral cytopathic effect (CPE) assay for human interferon-beta, when~     given as a single dose, when given once per week for 4 weeks, and compared with standard IM~     AVONEX® when given as a single dose.~      To determine the pharmacodynamic (PD) properties of a new inhaled formulation of interferon~     beta-1a, as measured by serum neopterin and 2-microglobulin, when given as a single dose,~     when given once per week for 4 weeks, and compared with standard IM AVONEX® when given as a~     single dose.~   "
130208|NCT01863056|"~     The purpose of this study was to determine whether the installation of sit-stand work~     stations could lead to decreased sedentary time and increased physical activity during the~     workday among sedentary office workers.~   "
130209|NCT01863043|"~     The primary purpose of this study is to determine nutrition outcomes and risks to~     gastrointestinal integrity and function of aspirating for routine gastric contents prior to~     each feeding in very low birth weight premature infants.~   "
130210|NCT01863030|"~     The objective of this study is to collect efficacy, safety and utility data with Phasix™ Mesh~     in ventral and incisional repair procedures by evaluating the following:~        1. Hernia recurrence rate of ventral and incisional hernias post repair with Phasix™ Mesh~          for up to 12 months post surgery.~        2. Perioperative, short-term and long-term procedural and/or device related complications.~        3. Abdominal Wall Function and mobility.~   "
130211|NCT01863017|"~     The purpose of this study is to determine the effects of transcranial direct current~     stimulation (tDCS) as it modifies hyperphagia in obese subjects, non-obese subjects, and~     subjects with Prader-Willi syndrome (PWS).~   "
130212|NCT01863004|"~     Dysferlin is a protein with an important role in the repair of muscle surface membranes.~     Mutations in dysferlin cause different forms of muscular dystrophies. Dysferlinopathies are~     inherited in an autosomal recessive manner, and many patients with this disease harbor~     mis-sense mutations in at least one of their two pathogenic DYSF alleles. These patients have~     significantly reduced or absent dysferlin levels in skeletal muscle, suggesting that~     dysferlin encoded by mis-sense alleles is rapidly degraded by the cell's quality-control~     system. In a series of in-vitro experiments we showed that mis-sense mutated dysferlin can be~     salvaged from degradation by proteasomal inhibition. This resulted in an increase of~     functional dysferlin protein and a subsequent repair of plasma membranes of cultured~     patient-derived muscle cells. In this proof-of-concept study we would like to test wether~     proteasomal inhibition can salvage mis-sense mutated dysferlin in patients harboring certain~     dysferlin mis-sense mutations.~   "
130213|NCT01862991|"~     This research study investigates the use of a drug, mifepristone, given before second~     trimester abortion. Mifepristone is a medication that is approved for medical abortion during~     the first trimester. It also has been used prior to abortion in the early seconds trimester~     (14-16 weeks gestation) and for medication abortion in the second trimester (also called~     induction abortion). This medication has effects on the uterus that may help dilate, or open,~     the cervix. Abortion requires opening of the cervix to safely remove the pregnancy. Cervical~     dilation, or opening, is essential to both ease of completion of procedure and reducing~     complications that can occur. These complications include laceration, or tearing, of the~     cervix and perforation of the uterus (a hole made unintentionally in the muscle wall of the~     uterus) and are not expected to be increased in the study. Dilation of the cervix is usually~     achieved by placing thin rods (cervical dilators) through the cervix. These rods then absorb~     the moisture of the vagina and slowly expand, opening the cervix. The standard method of~     dilation is performed at the clinic and involves the placement of cervical dilators the day~     before the procedure. This procedure can be uncomfortable. A prior study showed that~     mifepristone reduces the number of osmotic dilators that need to be placed prior to the~     procedure after 19 weeks gestation. We aim to investigate mifepristone as a potential adjunct~     to cervical dilation or used alone, without dilators, as method of cervical preparation with~     the hopes of reducing barriers imposed by painful procedures and time in clinic and away from~     work/home that the current approach involving dilators requires.~   "
130214|NCT01862978|"~     The goal of this study is to show the efficacy and safety of heparin and nadroparin in the~     acute phase of ischemic stroke. Therapeutic agents are administered at intervals of 4.5 to 2~     hours after onset of clinical signs. Overall administration of anticoagulant agents will test~     72 hours.~      Randomized patients will be divided into three groups. The first group of patients will~     receive heparin intravenously at the beginning of 2500 UI bolus intravenously, followed by~     intravenous pump 1000 UI / h (18-20 IU / kg / hr) to reach 2-2.5 times the baseline aPTT.~     After 24 hours, patients will receive the group Nadroparin subcutaneously in the therapeutic~     dose.~      Second group of patients will be administered subcutaneously Nadroparin the therapeutic dose~     as recommended.~      The third group of patients are those who will receive placebo intravenously and 24 hours~     after receiving nadroparin subcutaneously in the therapeutic dose.~      All patients will receive after 24 hours of starting treatment 100 mg of aspirin per orally.~      For initiation of treatment will be assessed:~        -  Modified Rankin Scale, National Institutes of Health Stroke Scale, inclusion, exclusion~          criteria~        -  Sign the informed consent and patient randomization~        -  Laboratory parameters: glucose, creatinine, GGT, K, Na, Cl, blood count, basic~          coagulation~        -  Women of childbearing age (pregnancy test)~        -  History, clinical presentation, medical history, basic internal review of the status~          (blood pressure, pulse, body temperature, etc.).~        -  Initial CT examination of the brain~        -  EKG~        -  USG sections of extracranial carotid and vertebral arteries~        -  special hematology factors~      If a patient meets all the necessary criteria, he may be given the test substance. During the~     first 24 hours will be monitored at regular intervals vital functions.~      After 24 hours, each patient received subcutaneous Nadroparin the therapeutic dose and also~     100 mg of aspirin per orally.~      In the interval from 24 to 30 hours of starting treatment the patient will be made:~        -  Control CT brain~        -  EKG~        -  Basic coagulation~        -  Reduction to stop treatment for newly identified haemorrhage or severe and extensive~          focal cerebral ischemia by CT scan~        -  special hematology factors~           72 hours, 7, 30 and 90 days after starting treatment, the patient's clinical evaluation~          using the Modified Rankin Scale, National Institutes of Health Stroke Scale and Barthel~          Index.~      Safety endpoints: mortality, adverse side effects, bleeding~   "
130215|NCT01862965|"~     In this study patients with moderate to severe chronic graft-versus-host disease will be~     treated with a combination of prednisone and everolimus. Patients will be treated on the~     study for a maximum of 12 months and followed up for another 12 months.~      The primary hypothesis of this study is that the addition of everolimus to prednisone~     increases response rates without increasing treatment related mortality or mortality due to~     relapse of underlying disease.~   "
130216|NCT01862952|"~     Stroke is a major cause of epilepsy. The pathophysiological mechanisms of poststroke epilepsy~     are not known. Subclinical epileptiform discharges could contribute to the neuronal damage~     and influence functional outcome. Electro-encefalography (EEG) is the golden standard to~     detect interictal, ictal and subclinical epileptic brain activity.~      Patients admitted to the stroke unit with an ischemic or hemorrhagic cerebrovascular attack~     will undergo a 24 hours video-EEG monitoring to detect epileptiform discharges. Clinical and~     paraclinical (imaging, serum markers of neuronal damage) parameters will be analysed together~     with the EEG results. The EEG results will be correlated with the occurence of epileptic~     seizures and functional outcome and mortality in the acute phase and in the long-term. When~     subclinical epileptic discharges are found on the EEG, patients will be asked to participate~     in a second part of the study where they will be randomised into a treatment (with an~     anti-epileptic drug) versus no-treatment group for a period of 6 months. Outcome parameters~     will be the occurrence of epileptic seizures, mortality and functional outcome.~      Our main hypothesis is that the occurrence of subclinical epileptiform discharges during the~     acute phase following stroke influences functional outcome.~   "
130217|NCT01862939|"~     This is a randomized, placebo-controlled, 2-part, sequential, single ascending dose study.~      Part 1 is planned as 6 sequential escalation treatment groups. Part 2 is a randomized,~     placebo-controlled, two-period sequential pharmacodynamic (PD) arm.~   "
130239|NCT01862653|"~     Post traumatic stress disorder (PTSD) has emerged as a significant problem among troops~     returning from combat zones. A majority of these veterans will report difficulty maintaining~     or initiating sleep. The purpose of this research will be to conduct a prospective,~     randomized, wait list controlled, small scale feasibility study to examine if the use of an~     auricular acupuncture regimen improves quality of sleep for Operation Iraqi Freedom/Operation~     Enduring Freedom (OIF/OEF)veterans with PTSD receiving standard PTSD treatment. Hypothesis:~     Objective and subjective sleep disturbances and sleep quality will be improved in OIF/OEF~     veterans who receive auricular acupuncture in conjunction with standard PTSD therapy or~     standard therapy alone.~   "
130240|NCT01862640|"~     To compare the efficacy of 2 fixed doses of brexpiprazole with placebo in subjects with~     agitation associated with dementia of the Alzheimer's type.~   "
130218|NCT01862926|"~     Interstitial lung disease (ILD) is characterised by inflammation and scarring of the lung and~     is the leading cause of death in patients with systemic sclerosis, and contributes~     significantly to morbidity and mortality in many other connective tissue diseases (CTDs) such~     as polymyositis/dermatomyositis and mixed connective tissue disease. When ILD is extensive~     and/or progressive, immunosuppressive medication is often required to stabilize lung disease~     and alleviate symptoms. Current standard care for CTD associated ILD is extrapolated from~     studies performed in individuals with systemic sclerosis and comprises low dose~     corticosteroids and intravenous cyclophosphamide followed by oral azathioprine. In some~     individuals even this intensive immunosuppression is insufficient to prevent deterioration,~     and in a significant minority of affected individuals this results in respiratory failure and~     death. Rituximab has recently been reported as an effective 'rescue therapy' for stabilizing~     and even improving ILD in this patient group. Based on observations gained from this~     experience, the investigators believe that rituximab is a potential important alternative to~     current best therapy for this patient group. This study has therefore been initiated to~     evaluate the efficacy of rituximab (compared with standard therapy) in patients with~     progressive CTD related ILD.~   "
130219|NCT01862913|"~     Background: Most adolescents suffering depression are treated in primary care clinics.~     Cognitive-behavior therapy (CBT) is effective in the treatment of adolescent depression. The~     availability of appropriately trained CBT therapist may be limited, especially in primary~     care clinics. One way to increase the availability of CBT is to use computer-assisted CBT~     (c-CBT). It can be effective in the treatment of adults, although the outcomes in adolescents~     remain unclear.~      Purpose: The purpose of this study is to determine whether a computer-assisted~     cognitive-behavioral therapy is effective for the treatment of depression in adolescents~     between 15 and 19 years of age in 4 primary care clinics in Santiago, Chile.~      Study design: A two-arm single-blind (outcomes assessor) randomized controlled trial will be~     carried out with 216 adolescents. The efficacy, the adherence, and acceptability of the~     computerized-assisted cognitive behavioral therapy will be evaluated.~   "
130220|NCT01862900|"~     This study will test the investigational antibody, MEDI6469 (anti-OX40), in combination with~     stereotactic body radiation in breast cancer patients that have liver or lung metastases and~     have received systemic therapy and have progressive disease. The investigators hypothesize~     that SBRT directed at metastatic breast cancer lesions will result in a systemic anti-tumor~     immune system response. This amplified and directed immune response could result in~     anti-tumor responses.~   "
130221|NCT01862887|"~     The purpose of this study is to investigate the effect of PH-797804 following dosing of a 24~     mg oral tablet on the QTc interval~   "
130222|NCT01862874|"~     A study to evaluate the efficacy, immunogenicity, and tolerability of V501 (quadrivalent~     Human Papilloma Virus [HPV] [Type 6, 11, 16 and 18] L1 Virus-Like Particle vaccine,~     GARDASIL™) in healthy, 16- to 26-year old Japanese males. The hypotheses tested are: 1) V501~     reduces the combined incidence of HPV 6-, 11-, 16-, or 18-related persistent infection~     compared with placebo, and 2) V501 reduces the combined incidence of HPV 6-, 11-, 16-, or~     18-related persistent infection, condyloma acuminata, penile/perianal/perineal~     intraepithelial neoplasia, or penile, perianal, or perineal cancer compared with placebo.~   "
130223|NCT01862861|"~     Bioidentical Hormone Replacement Therapy (BHRT) to assess a change in the number of various~     menopausal symptoms such as hot flashes and night sweats in surgically or naturally induced~     peri or post-menopausal women.~   "
130224|NCT01862848|"~     To evaluate the change in patient pain perception with the use of a topical compounded pain~     cream regimen.~   "
130225|NCT01862835|"~     Repletion of testosterone (T) in older men drives Growth Hormone secretion after its~     aromatization to estradiol (E2) by potentiating endogenous GH drive.~   "
130226|NCT01862822|"~     Urinary tract infection (UTI) is a frequently suspected cause of fever in young children,~     justifying urine cultures. Sampling procedures are decisive for the reliability of UTI~     diagnosis. Even though official guidelines recommend clean catch method, catheterization or~     suprapubic aspiration, urine bag collection remains widely used. In our experience, the rate~     of contaminated bag-obtained cultures reaches 30.2 %. In a recent study, the investigators~     have noticed that the rate of contaminated urine cultures was lower when children were kept~     in an upright position at the time of urine collection. The upright position could explain~     this decrease, perineum being less in contact with urine. These results are borderline~     significant, the investigators would like to confirm them with a specific study.~   "
130227|NCT01862809|"~     Background:~      - Normal bacteria and other tiny organisms (the microbiota) live in the mouth and nose. They~     contribute to human health in many ways, including digesting food and balancing hormones.~     Testing samples from the mouth can show how microbiotas are related to health and disease.~     However, the microbiota in a person's mouth differs depending on the methods of collection~     and the part of the mouth that is tested. Understanding what can change the microbiota~     (including mouth sites, and what a person eats or smokes) will give more information on how~     to study oral microbiota and smoking-related cancers and other diseases.~      Objectives:~        -  To see how smoking affects the microbiotas in mouth and nose.~        -  To determine which collection method for mouth specimens should be used for studying~          microbiota.~      Eligibility:~        -  Individuals at least 18 years of age who have been using tobacco products regularly for~          at least 5 years.~        -  Individuals at least 18 years of age who have never smoked.~      Design:~        -  Participants will be screened with a physical exam and medical history.~        -  Participants will have a dental exam. They will provide a saliva sample. The dentist~          will take swabs from the inside of the mouth, including the tongue, tonsils, gums, and~          teeth. The inside of the nose will also be swabbed.~        -  Participants will also fill out a questionnaire. It will ask about their history of~          smoking and consumption of alcohol, tea, and coffee. It will also ask about current~          medications, including antibiotics.~   "
130241|NCT01862627|"~     Clinical features, optical coherence tomography findings and surgical outcome in eyes with~     macular retinoschisis and detachment with normal tension glaucoma but without optic disc pit~     or high myopia were evaluated.~   "
133579|NCT01818843|"~     Based on the study about carbon monoxide in human inflammatory and other beneficial~     physiological function , now we'll be going to research its application in neonates .Phase 1~     Study as a foundation for the further test is, the safety and Adverse reaction study of~     newborn to inhaled CO~   "
130228|NCT01862796|"~     Background:~      - Sticking to a diet plan can be difficult, but is important for many different health~     reasons. Some people seem to have a harder time following and sticking to a diet plan than~     others. It is not clear whether people of different weights (lean or obese) might have~     differences in the way they adhere to diet plans. Researchers want to study three different~     groups of people based on their body mass index (BMI), which measures people based on their~     weight and height. The study will place the participants on a 6-week diet and see how well~     they follow the diet. The information from this study may help develop better weight-loss~     plans and healthy diet ideas.~      Objectives:~        -  To understand what factors affect adherence to a diet plan.~        -  To collect information for future studies that may improve people's ability to stick to~          diets.~      Eligibility:~      - Individuals at least 18 years of age who are lean (BMI between 18.5 and 25) or obese (BMI~     greater than 30).~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. They will have a full-body scan to measure fat and muscle.~          They will also answer questions on eating behaviors, mood, and desire to change eating~          patterns.~        -  Participants will be separated into three groups. Each group will have a different diet.~          The lean group will have a heart-healthy diet designed to maintain the same weight. One~          of the obese groups will also have a heart-healthy diet designed to maintain the same~          weight. The other obese group will have a heart-healthy weight loss diet. In all groups,~          all food will be provided by the study doctors. Participants should not eat any food~          other than that provided for the study.~        -  Everyone will start with a 1-week food testing period to find the right number of~          calories for each group. After this first week, participants will attend one diet~          counseling session per week and will be contacted randomly once a week to check on the~          foods they have had in the past 24 hours. Participants will complete daily food diaries~          on paper as well as daily food records using a smart phone.~        -  Participants will come to the clinic twice a week to pick up the diet food. On one of~          those days, they will also have their counseling session.~        -  The study will last for 6 weeks. At the final study visit, participants will repeat the~          tests from the screening study.~   "
130229|NCT01862783|"~     Background:~      - Malaria is a disease caused by a parasite that infects the blood. It affects millions of~     people every year and frequently harms or kills pregnant woman and infants. Researchers are~     looking for treatments that may help pregnant women in areas of the world where malaria is~     common. To do so, they want to collect blood and other samples from pregnant women in~     south-central Uganda. They will also collect samples from newborn babies if the mother agrees~     to it.~      Objectives:~      - To collect biological material such as blood samples from pregnant women and newborns.~      Eligibility:~        -  Women between 14 and 45 years of age who are pregnant or are in labor.~        -  Participants will be from the Kalisizio area of south-central Uganda.~      Design:~        -  Women who are pregnant will provide blood and urine samples.~        -  Women who are in labor will allow researchers to collect samples from their baby after~          the delivery. Samples will be taken of placenta tissue and umbilical cord blood. The~          baby will also be weighed and measured. Researchers will look at the baby's physical~          appearance and muscle strength.~        -  Treatment will not be offered as part of this study.~   "
130230|NCT01862770|"~     Background:~      - A health event can be a powerful motivator for abrupt behavior changes. For instance, many~     people who smoke stop after having a heart attack or being diagnosed with cancer. A relative~     s health event may have a similar effect. For instance, smokers may try to quit after~     learning that a parent or sibling has lung cancer. Researchers want to study relatives of~     people with lung cancer to see how the relative s diagnosis affects a person s willingness to~     quit smoking or have genetic testing.~      Objectives:~      - To study the impact of a relative s lung cancer diagnosis on a person s approach to genetic~     testing and smoking cessation services.~      Eligibility:~      - Current smokers between 18 and 55 years of age who are close blood relatives of people~     being treated for lung cancer.~      Design:~        -  Participants will be recruited through telephone surveys. Participants will log on to a~          password-protected website. The site has two educational sessions and three surveys to~          complete.~        -  Participants will also be offered free genetic testing. The test will see whether they~          have a gene that can reduce the effectiveness of some cancer treatment drugs. Those who~          agree to the test will collect a cheek swab sample at home and send the sample in for~          testing. They will receive the test results through the website.~        -  The surveys will ask about risk perceptions and emotional responses to the relative s~          diagnosis. They will also ask about smoking history, motivation to quit, and reactions~          to information about smoking and genetic risk.~        -  All participants will be able to receive free smoking cessation services.~        -  Six months after completing the surveys, participants will have a follow-up phone call.~          The call will ask whether participants used the smoking cessation services.~   "
130231|NCT01862757|"~     Background:~      - Some people who are obese may have decreased muscle strength. They may have greater muscle~     mass shown in scans, but they show poor results in exercise tests. Poor muscle strength might~     cause some of the difficulty with exercise performance. Researchers want to test muscle~     strength in the arms and legs of overweight women. They will also see how insulin resistance~     affects muscle strength in these women.~      Objectives:~        -  To test muscle strength in overweight women.~        -  To see if insulin resistance affects muscle strength.~      Eligibility:~      - Women at least 18 years of age who are overweight (body mass index greater than 25 kg/m2).~      Design:~        -  Participants will be asked to fast before having an initial blood test to measure~          glucose and insulin levels.~        -  On a different day, they will have the strength testing. The first test will measure leg~          muscle strength by testing the quadriceps and the hamstrings. The second test will~          measure arm muscle strength by testing the biceps and triceps. The final test will~          measure hand muscle (grip) strength.~        -  All the tests should take about an hour.~   "
130232|NCT01862744|"~     Background:~      - Parkinson's disease causes slow movements, stiffness, and tremor. It can get worse over~     time, and in some cases can lead to dementia. Researchers are interested in how dementia~     affects the brain in people with Parkinson's disease. They will study both people with~     Parkinson s disease and healthy volunteers. They will give tests of thinking and memory, and~     look at brain activity using imaging studies. This may provide more information on what parts~     of the brain are not working well in people who have dementia related to Parkinson's disease.~      Objectives:~      - To use imaging studies to see what parts of the brain do not work well in people with~     dementia caused by Parkinson's disease.~      Eligibility:~        -  Individuals at least 40 years of age who have Parkinson s disease.~        -  Healthy volunteers at least 40 years of age.~      Design:~        -  Participants will be screened with a medical history and physical exam.~        -  This study requires two outpatient visits over 2 days.~        -  Participants will have tests of thinking, memory, and concentration. They will answer~          questions and fill out questionnaires. The tests will also look at how quickly they can~          move and handle small objects. The tests will take about 3 hours.~        -  Participants will have magnetic resonance imaging to study the brain. Functional MRI~          (fMRI) can show what parts of the brain are used when performing a task. Participants~          will respond to images on a computer screen during fMRI.~        -  Treatment will not be provided as part of this study.~   "
130253|NCT01862458|"~     The objective of this study is to scientifically evaluate a new substrate for fibrinolysis~     compared to our standard tPA.~      The hypothesis, driven by a recent prospective trial, is that tPA may benefit from the~     addition of DNAse.~      The primary outcome variable between the two techniques will be length of hospitalization~     after initiation of treatment.~   "
130254|NCT01862445|"~     This is a non interventional study to evaluate the efficacy and safety of Chlorambucil plus~     Rituximab as firstline therapy in elderly and/or unfit patients affected by B-cell Chronic~     Lymphocytic Leukemia (B-CLL).~   "
130233|NCT01862731|"~     Background:~      - Researchers are interested in how the muscles affect the movement of the knee cap. These~     muscles may be related to different kinds of knee pain that are not caused by an injury or a~     disease. Imaging studies such as magnetic resonance imaging (MRI) can be used to look at~     these muscles. To study these muscles and how they move, researchers will use MRI to look at~     healthy individuals and individuals with knee cap pain.~      Objectives:~      - To study how changes to the muscles around the knee can influence knee pain.~      Eligibility:~        -  Individuals between 18 to 55 years of age who have knee cap pain that cannot be~          explained by a specific injury or disease.~        -  Healthy volunteers between 18 and 55 years of age.~      Design:~        -  Participants will be screened with a physical exam and medical history.~        -  This study requires two visits. Each visit will use standard MRI sequences to take~          images of the knee in motion and at rest.~        -  On the first visit, the MRI scan will look at the knee in its natural state.~          Participants will move the knee up and down for 1 to 3 minutes at a time during the~          scan.~        -  On the second visit, a local anesthetic agent will be injected into the muscle of the~          thigh. The anesthetic will block this muscle from generating force for 2 or 3 hours.~          Participants will move the knee up and down for 1 to 3 minutes at a time during the MRI~          scan.~   "
130234|NCT01862718|"~     Background:~      Pilot study to assess feasibility for combining treatment modalities that should be~     synergistic (radiation and thermal ablation).~      Thermal ablation with Radiofrequency Ablation (RFA) and microwave ablation (MWA) are standard~     treatments for focal neoplasms in the liver.~      High volume or scattered locations of tumor burden results in inability to successfully use~     this technology for a large proportion of patients with hepatic neoplasms.~      Methods to enhance treatment volumes could be advantageous in potentially increasing the~     indications for thermal ablation or the number of patients benefitting from local ablation.~      Primary objective:~      To determine the safety of combining 2 standard therapies (thermal ablation and external beam~     radiation therapy) for liver neoplasms up to 10 cm diameter.~      Eligibility:~      Patients greater than 18 years of age with pathologically proven unresectable primary or~     metastatic hepatic neoplasms~      Patients whose extent of hepatic metastases represents approximately less than 60% of total~     liver volume AND whose extrahepatic metastatic disease is determined to be minimal~      ECOG performance status of less than or equal to 2 and a life expectancy of more than 3~     months~      Patients with a history of chemotherapy, radiation therapy, or biological therapy for at~     least 4 weeks prior to starting study treatments, and 4 weeks after treatments Patients must~     not have an acute, critical illness~      If clinical or imaging evidence for cirrhosis present, then Bilirubin must be less than 3~     mg/dl and Child-Pugh Classification A, (Class B & C are excluded)~      Design:~      Patients will undergo external beam radiation as well as thermal ablation according to~     standard operating procedures of the NCI and NIH CC.~      Patients will be monitored using the standard imaging studies when clinically warranted.~      Patients may be treated with a second (or more) thermal ablation procedure ALONE if it is~     deemed beneficial for the patient by the investigator.~      The sample size will be 10 evaluable patients~   "
130235|NCT01862705|"~     Thoracic spine thrust manipulation (TSM) has been shown to be an effective intervention in~     the management of patients with neck pain. However the mechanisms for pain relief associated~     with this intervention remain largely unexplained. Recent evidence suggests structures within~     the brain may have a role in creating responses of pain relief. This study aims to use~     functional magnetic resonance imaging (fMRI) to determine if there is a change in blood flow~     to structures within the brain following TSM in patients with neck pain. All patients will~     undergo fMRI while receiving painful stimuli directed to two separate sites, the cuticle of~     the index finger and the great toe. Subjects will then receive either TSM or~     sham-manipulation and then immediately undergo a second fMRI scan receiving the same painful~     stimuli. The primary outcome of interest is the shift in blood flow within the brain before~     and after TSM or sham manipulation as measured by Blood Oxygen Level Dependent (BOLD)~     technology. This study will be the first to examine this type of response to manual therapy~     within the brain in patients with neck pain.~   "
130236|NCT01862692|"~     This innovative interactive Internet-based parent education intervention will help serve to~     promote the social emotional development and communication skills of infants to decrease the~     chances of child maltreatment in low-income, culturally diverse, families.~   "
130237|NCT01862679|"~     The most common forms of renal replacement therapy currently in use are high flux~     haemodialysis (HF-HD) and haemodiafiltration (HDF). Although these techniques appear similar~     to the patient, there are important differences in what happens to the blood as it travels~     through the dialysis machine.~      During HDF, the machine controls hydrostatic pressure across the dialyser to remove~     additional water together with toxins from the blood and this fluid volume is continually~     replaced with an ultra-pure solution. HDF has a theoretical advantage removing more waste~     substances, especially larger molecules, from the blood than HF-HD which may be of benefit to~     the patient in the medium to long term.Despite the theoretical advantages, trials have so far~     been unable to find any significant difference in death rates or the development of health~     problems among patients on HDF or HF-HD.~      It is therefore important to examine other factors which may help doctors and patients to~     decide which treatment to use. The investigators have designed a study which aims to answer~     three main questions:~        1. Does HDF make patients feel better?~        2. Is blood pressure more stable on HDF in comparison with HF-HD?~        3. Are Phosphate levels and other blood parameters better controlled with HDF than HF-HD?~      The investigators will do this by randomly assigning patients on HF-HD to receive 2 months of~     either HF-HD or HDF with as equivalent treatment prescriptions as possible and without the~     patient knowing which treatment they are receiving. After two months the patients will switch~     to the alternative form of dialysis for a further two months. During the study the~     investigators will ask the patients how long it took them to recover from the preceding~     session of dialysis, assess the frequency of symptomatic low blood pressure and also perform~     blood tests at set intervals to measure specific blood parameters.~   "
130238|NCT01862666|"~     Barrett's esophagus (BE) is a pre-neoplastic condition formed by the metaplasia of the normal~     squamous mucosa of the distal esophagus into a specialized intestinal mucosa. Its development~     is mostly associated with chronic injury from gastroesophageal reflux. BE is widely~     considered the leading risk factor for the development of esophageal adenocarcinoma (EAC).~      Volumetric laser endomicroscopy (VLE) can be thought of as an analogous technique to~     ultrasound, however, instead of producing an image from the scattering of sound waves, it~     utilizes optical scattering based on differences in tissue composition to form a~     two-dimensional image. The benefit of VLE over ultrasound is that it is capable of generating~     cross-sectional images of tissues with an axial-resolution of up to 10 micrometers, which is~     comparable to low-power microscopy.~      The proposed trial will evaluate the ability of physicians to use VLE to visualize high grade~     intraepithelial neoplasia (HGIN) or intramucosal adenocarcinoma (IMC) in both the ex-vivo and~     in-vivo setting and correlate those images to standard histology of endoscopic mucosal~     resection specimens as the gold standard.~   "
130301|NCT01861821|"~     The purpose of this study is to determine whether multiple ports improve the analgesic~     efficacy of flexible catheters used for the provision of epidural analgesia during the entire~     continuum of labor and delivery~   "
130302|NCT01861808|"~     The project is aimed to develop predictive indices of spinal cord injury severity through the~     analysis of cerebrospinal fluid of patient collected during acute injury.~   "
130242|NCT01862614|"~     Infiltration (injecting next to the tooth) injections are common in dentistry and a number of~     studies have shown that articaine anesthetic, when injected next to a lower molar, is more~     effective than a local anesthetic injection of lidocaine. However success rates have not been~     as high as hoped for. No objective study has addressed the success rate of buffering~     articaine in a mandibular primary buccal infiltration of the first molar. Therefore, the~     purpose of this prospective, randomized, double-blind, crossover study is to compare the~     degree of pulpal anesthesia obtained with a buffered 4% articaine with 1:100,000 epinephrine~     solution versus a non-buffered 4% articaine with 1:100,000 epinephrine solution as a primary~     infiltration in the mandibular first molar. The investigators will also record the pain of~     injection and postoperative pain.~   "
130243|NCT01862601|"~     This research study is being done to see how well the JetTouch Needle-Free Endoscopic~     Injection System is able to deliver a solution safely into the bladder wall. The JetTouch~     Needle-Free Endoscopic Injection System is a jet injector that allows fluids to be injected~     into the bladder without using a needle. It is hoped that this method will provide a reliable~     and consistent method to deliver drugs into the bladder wall.~   "
130244|NCT01862588|"~     Record the renal resistive index and hemodynamic parameters ( record the cardiac output and~     stroke volume if the patient's next to kin agree to undertake a PiCCO monitoring ) before and~     after resuscitation for severe sepsis or septic shock patients, to determine whether the~     changes of resistive index or hemodynamic parameters, especially the cardiac output can be a~     better parameter to predict AKI~   "
130245|NCT01862562|"~     Elderly patients have poorer preoperative conditions than younger patients. Therefore,~     minimally invasive surgery should be an effective treatment method for elderly patients. The~     investigators conducted a randomized trial that compared laparoscopic surgery and~     conventional open surgery in elderly patients who were 75 years old or over. The purpose of~     the present study was to clarify the effect of laparoscopic surgery in elderly patients. In~     our hypothesis of this trial, laparoscopic surgery is superior to conventional open surgery~     in short-term results, and same outcome in long -term results. Therefore, laparoscopic~     surgery would be recommended as standard procedure in an elderly colorectal patient.~   "
130246|NCT01862549|"~     This study examines feasibility and preliminary efficacy of Dialectical Behavior Therapy~     adapted to children (DBT-C). DBT-C as compared to treatment-as-usual (TAU) is hypothesized to~     have lower drop-out rate, and higher treatment attendance and satisfaction. Further, DBT-C as~     compared to TAU will have significantly greater reduction in symptoms of Disruptive Mood~     Dysregulation disorder, including verbal and behavioral outbursts and angry/irritable mood.~   "
130247|NCT01862536|"~     The functional, social, and economic burden of chronic obstructive lung disease (COPD) on the~     healthcare system is extraordinary. COPD is the fourth leading cause of death in the United~     States, and some estimates attribute up to $33.2 billion in health care costs to~     COPD-associated morbidity and mortality annually. The burden of COPD to the VA Healthcare~     system parallels these findings. According to the VA HSR&D Health Economics Resource Center,~     COPD ranks 5th among the 40 most common chronic clinical conditions in the U.S. Veteran~     patient population, is responsible for >14,000 VA hospital admission annually, and increases~     by $1,051/patient the total annual health care cost burden on the VA Healthcare system.~     Importantly, COPD is associated with frequent emergency room visitation and/or~     hospitalization patients. Pulmonary hypertension is a common co-morbid condition that worsen~     morbidity and mortality in patients with COPD. This study will examine the potential for~     tadalafil, a phosphodiesterase type-5 (PDE-5) inhibitor to improve functional status by~     decreasing pulmonary hypertension. Results from this study are expected to define the~     potential use of PDE-5 inhibitors in COPD-induced pulmonary hypertension. If successful, this~     treatment option may improve quality of life and outcomes for the large number of Veterans~     afflicted with PH due to COPD.~   "
130248|NCT01862523|"~     Capsaicin nasal spray is used in daily practice against IR without knowledge about the exact~     mechanisms involved in this treatment. Therefore, this study aims to address this issue by~     studying the functional (electrophysiologic) changes after specific stimulations in IR~     patients and healthy controls before and after capsaicin/placebo treatment.~   "
130249|NCT01862510|"~     The study evaluates whether hypothyroid patients requiring elevated doses of levothyroxine to~     maintain a euthyroid state are at increased risk of having celiac disease. It also attempts~     to determine if there is a threshold level of levothyroxine needed to maintain a euthyroid~     state in patients with hypothyroidism that should prompt serologic testing for celiac~     disease.~   "
130250|NCT01862497|"~     The purpose of this study is 1) to determine what physiologic factors (extracellular fluid~     overload or vasoconstriction) contribute more to increased blood pressure levels between~     dialysis treatments in hemodialysis patients whose blood pressure increases and decreases~     during hemodialysis and 2) to determine whether carvedilol provides better control of blood~     pressure between dialysis treatments than prazosin in patients whose blood pressure increases~     during dialysis.~   "
130251|NCT01862484|"~     Children with Attention Deficit Hyperactivity Disorder (ADHD) aged 9-12 years of age will be~     placed on a restriction diet for a 5 week period. Children will be randomized to either~     receive daily snacks that conform to the diet or will violate the diet (Ruse diet) in a~     double blind fashion. It is hypothesized that children who are consistently on the restricted~     diet (relative to those on the ruse diet) will show improvements in ADHD symptoms.~   "
130252|NCT01862471|"~     Deep Vein Thrombosis (DVT) is a life threatening condition and a serious concern among~     hospitalized patients, with death occurring in approximately 6% of cases. It involves the~     formation of a clot where stagnant blood flow occurs, predominantly in the deep veins of the~     legs. Three mechanisms underlie DVT, venous stasis (slowing or stopping of the blood),~     hypercoagulability (increased clotting) and damage to blood vessel endothelium (damage to~     blood vessel wall), collectively known as Virchow's triad.~      Intermittent pneumatic compression (IPC) and neuromuscular electrical stimulation (NMES) have~     been shown to improve lower limb blood flow. However, few studies have directly compared the~     two methods and those that have, have used outdated NMES devices.~      The objective of this study is to compare the effectiveness of a modern NMES device to~     intermittent pneumatic compression in terms of blood flow.~   "
130303|NCT01861795|"~     The purpose of this observational study is to collect data on vital signs, oxygen~     requirements and other data related to ventilator care in preterm neonates under standard of~     care treatment.~   "
130255|NCT01862432|"~     At birth, the passage from intrauterine to the aerial life can be considered as one of the~     most stressful and painful life events. Skin-to-skin contact (STSC) with mother is known to~     provide numerous virtues and World Health Organisation (WHO) recently supported the~     introduction of such care among healthy, term-born neonates. Here, the investigators~     hypothesized that immediate STSC could reduce neonatal, birth-evoked stress and pain. This~     randomized controlled trial (RCT) aimed to compare the pain and stress response of C-section~     born neonates that received either immediate STSC with mother (intervention) or classical~     support and monitoring (control).~   "
130256|NCT01862419|"~     This study will randomize hospitalized patients with acute kidney injury (AKI) to usual care,~     or an electronic alert intervention. The electronic alert will be in the form of a text page~     that will be sent to the covering clinician and unit pharmacist once per patient with AKI at~     the time lab results are uploaded. The investigators hypothesize that such an alert will~     improve outcomes in these patients.~   "
130257|NCT01862406|"~     Although generic drugs are pharmacologically equivalent to their brand-name counterparts,~     prejudices against the former remain strong among patients and doctors. In a randomized~     controlled field experiment, this research assesses the extent to which generic (versus~     brand-name) labels affect patients' consumption dosage, medication compliance and reported~     pain.~   "
130258|NCT01862393|"~     This study aims to examine the variation in muscle torque and discomfort produced when~     electrically stimulating quadriceps femoris using pulsed current with three different phase~     durations in order to establish whether there are any advantages or disadvantages in varying~     the phase duration over the range examined.~   "
130259|NCT01862380|"~     The risk of adrenal insufficiency in patients with nonclassical congenital adrenal~     hyperplasia due to 21-hydroxylase deficiency is not well documented. Indication of cortisol~     replacement therapy in situation of acute stress or at long term is thus controversial. The~     mineralocorticoid reserve of these patients has never been evaluated.~      Hypothesis: The glucocorticoid and mineralocorticoid function of the adrenal glands in women~     with nonclassical 21-hydroxylase deficiency is comparable with the adrenal functions of~     healthy age- sexe- and BMI-matched subjects.~   "
130260|NCT01862367|"~     This study is conducted globally. The aim of this observational study is to investigate the~     incidence of specific adverse drug reactions associated with the use of recombinant factor~     XIII (NovoThirteen®) in patients with congenital FXIII A-subunit deficiency (congenital FXIII~     deficiency), comprising FXIII antibodies, allergic reactions, embolic and thrombotic events~     and lack of therapeutic effect.~      The study will aim at observing all patients exposed to NovoThirteen® in the EU, and~     additional patients from selected non-EU countries. Recombinant FXIII (rFXIII) is registered~     in EU and Switzerland as NovoThirteen® and in Canada as Tretten®.~   "
130261|NCT01862354|"~     The purpose of this randomized controlled study is to compare the postoperative analgesic~     effect of a continuous wound infusion of local anesthetics and a sole transverse abdominal~     plan (TAP) regional block in the surgery of Abdominoplasty Combined With Flank Liposuction.~     Local anesthetics products used are ropivacaine combined with clonidine. Similar amount of~     local anesthetics and clonidine are used.~   "
130262|NCT01862341|"~     In-Shape Nutritional Milk Powder is a nutritional milk powder containing fibers, probiotics~     and other nutrients. This study will focus on the effects of fiber and probiotics on~     digestive health and health well being in selected Filipino mothers~   "
130263|NCT01862328|"~     This is an open-label, multicenter, phase 1b, dose escalation study of MLN4924 plus~     docetaxel, gemcitabine or combination of carboplatin and paclitaxel in adult patients with~     solid tumors.~   "
130264|NCT01862315|"~     The purpose of this study is to use both, liver pump treatment and systemic chemotherapy, to~     assess the effects this type of treatment has on the patient and the tumor. Liver pump~     treatment uses a metal pump that is surgically placed in the abdomen and gives chemotherapy~     directly to the liver. Systemic chemotherapy gives chemotherapy through a vein [intravenously~     (IV)] and treats the whole body. This type of treatment has been done before and had shown~     that people with both pump and systemic chemotherapy had improved results. The investigators~     hope that this combination of treatments improves the response to chemotherapy and reduces~     the spread of the disease.~      Another purpose of this study is to learn the clinical importance of a specific type of MRI~     scan. The investigators would like to see if this type of MRI will help predict the response~     to the treatment and see if they could help the physician with their treatment plan. These~     scans will be done at specific time points.~      The last purpose of this study is to learn more about how the tumor interacts with the~     chemotherapy. This will be done through a biopsy taken during surgery and blood draws at~     specific time points.~      Permission from patients entering the study will be obtained to take normal and tumor liver~     biopsies at the time of surgery. These samples are voluntary and optional.~   "
130265|NCT01862302|"~     Will the use of prophylactic Haloperidol for patients undergoing open heart surgery reduce~     the incidence, duration, and severity of post cardiotomy delirium?~   "
130266|NCT01862289|"~     Most of asthmatics patients remain uncontrolled despite an inhaled steroids treatment.~     Chronic hyperventilation syndrome (also called Idiopathic Hyperventilation) occurs in 20 to~     40% of asthmatic patients. The purpose of the study is to assess the prevalence of chronic~     hyperventilation syndrome in a specific population of difficult-to-treat asthmatics patients,~     those who receive daily high doses of inhaled steroids (≥ 1000 µg of fluticasone with an~     additional treatment by a long-acting beta 2-agonist (LABA) and who remain uncontrolled~     (Asthma control test (ACT) < 18). We plan to realize a systematic assessment of the diagnosis~     of chronic hyperventilation syndrome with the Nijmegen questionnaire, blood gases at rest,~     hyperventilation testing and Cardiopulmonary Exercise Testing(CPET). We also will collect~     demographic information as well as information about asthma history, asthma control and~     treatment.~   "
130267|NCT01862276|"~     To investigate the prognosis due to presence or absence of bile duct resection in~     intrahepatic cholangiocarcinoma that require hepatic lobectomy.~   "
130268|NCT01862263|"~     The purpose of the study is to assess if the addition of vildagliptin as add-on therapy~     improves glucose variability in type 2 diabetes mellitus (T2DM) patients inadequately~     controlled with insulin, with special emphasis in hypoglycemic episodes measured by~     continuous glucose monitoring.~   "
130269|NCT01862250|"~     This research is being done to find out the safety of the investigational study drug,~     Clonidine Hydrochloride ( CLON). , in infants who are undergoing whole body cooling for the~     treatment of hypoxic ischemic encephalopathy (HIE). The only known and effective treatment~     for HIE is therapeutic hypothermia or whole body cooling for72 hours. During the cooling~     process, babies get agitated, shiver and are uncomfortable. To treat these side effects~     morphine is frequently used. CLON is very effective in decreasing shivering in adults and~     children. Furthermore, in some preclinical studies, clonidine has been shown to be~     neuroprotective (safe for the brain in models of brain injury)..This is a Phase I-II to~     determine if low dose CLON will reduce the incidence of shivering and whether it has short~     term cardiovascular safety. In this Phase I-II study, the investigators will determine the~     (i) the maximum tolerated dose of CLON during cooling for HIE, (ii) the effects of CLON on~     heart rate, blood pressure, core body temperature and cerebral autoregulation (ability to~     maintain constant blood flow to the brain) and (iii) association between blood levels and~     changes in the above parameters. In this study the investigators hope to find ways to improve~     sedation, shivering and agitation in newborn infants with HIE on the cooling protocol. Our~     ultimate goal is determine the potential neuro-protective properties of clonidine in newborn~     babies with HIE.~   "
130270|NCT01862237|"~     This project focuses on the physiopathology of left ventricular remodeling associated with~     type II diabetes in patients with aortic valve stenosis referred for surgical aortic valve~     replacement.~      The main objective is to compare the reverse left ventricular remodeling between patients~     with type II diabetes and case-control patients without diabetes at one(1) year after~     surgical aortic valve replacement.~      The secondary objectives are :~        1. assess the influence of type II diabetes on left ventricular remodeling in patients~          presenting with aortic valve stenosis,~        2. assess the predictive value of myocardial fibrosis and other LV characteristics present~          prior to aortic valve surgery on the LV reverse remodeling and their influence on~          cardiovascular events at one (1) year after surgery,~        3. assess the influence of type II diabetes on cardiovascular morbidity and mortality post~          aortic valve surgery.~      The investigators main hypothesis is that patients with type II diabetes and aortic valve~     stenosis requiring aortic valve replacement have poorer LV function and less favorable post~     surgery clinical outcomes than patients without type II diabetes.~   "
130271|NCT01862224|"~     The purpose of this study is to assess the impact of JNJ-38518168 on rheumatoid arthritis~     (RA) disease-related biomarkers in synovial biopsy tissue and blood in participants with~     active RA despite methotrexate (MTX) therapy and to assess the safety and tolerability of~     JNJ-38518168 over one year.~   "
130272|NCT01862211|"~     The deficiency of alpha-1 antitrypsin (DA1AT) is a genetic disorder of variable clinical~     expression, initially described in adults with pulmonary emphysema patients. In children, it~     is the second cause of neonatal cholestasis after biliary atresia and is a common indication~     for liver transplantation.~      Several genotypes for SERPINA1 gene coding for alpha-1 anti-trypsin were identified. The main~     ones are M / M, M / Z, M / S and Z / Z and each genotype is closely correlated with the~     concentration of blood A1AT. The estimate for France suggests a prevalence of genotype~     deficit Z / Z of the order of 1/6054, (9982 patients), which in 11% of cases, have liver~     disease (prolonged neonatal jaundice). Half of them will move towards the development of~     cirrhosis with portal hypertension, at worst liver transplantation.~      Currently, we do not know what are the clinical and genetic factors that predispose a patient~     A1AT deficiency develop liver damage. Recent studies have led us to think that polymorphisms~     in the gene SERPINA1, as well as that of the alpha-mannosidase 1 endoplasmic reticulum (Erman~     gene) could be a predictive marker of liver complications. Another possible candidate gene is~     one of the importin beta (KPNB1), a protein involved in the elimination of misfolded~     proteins. These data lead us to propose the study of genetic polymorphisms.~      The main objective of the study is to compare the allele frequencies of these polymorphisms~     between (i) a cohort of A1AT deficient patients and with hepatic symptoms (portal~     hypertension and its complications, severe liver failure leading to transplant or not, or an~     indication for liver transplantation) and (ii) a cohort of A1AT deficient patients without~     signs of hepatic call. To build this last cohort, we will include in the genetic study the~     family members of deficient patients, some of whom probably carrying a deficit genotype Z / Z~     but without any associated clinical manifestations. This will allow us to facilitate the~     establishment of genotype profiles / phenotype clearly identified, which then allow a more~     appropriate care for children who may have such a development, we will strive to achieve a~     haplotype interpretation of polymorphisms found.~      This study will be conducted in association with the DEFI-ALPHA study to identify clinical~     and biological prognostic factors such as age at diagnosis, the diagnostic mode, the results~     of liver biopsy (when available), the clinical course, family history, the existence of IUGR~     and long-term treatment.~      The secondary objectives of the study are :~        -  The measurement and interpretation of serum IL-8 in A1AT-deficient patients. Indeed, one~          study showed a higher IL-8 in patients with ulcerative colitis compared with healthy~          patients' serum. These considerations led us to hypothesize that IL-8 may be a marker of~          liver disease in A1AT deficiency.~        -  Preservation of blood samples for further study of other genes, which may be in the~          future suspected to be associated with the occurrence of liver complications. To this~          end, a DNA bank will be created. It will involve the children with a deficiency of~          alpha-1 antitrypsin and their family of 1st and 2nd degree in civil law (parents and~          siblings).~      This study is a continuation of the cohort DEFI-ALPHA (descriptive study of a cohort of~     children with DA1AT) and sought to identify the clinical and biological factors such as age~     at diagnosis, diagnosis mode, the result sets of the liver biopsy (when available), clinical~     course, family history, the presence of IUGR and long-term treatment.~      The only criterion for not-inclusion is, according to the subject, the lack of consent of the~     child and his parents, the lack of consent of the adult patient, or the lack of consent of~     the witness. Demographic and clinical history data (for parents and brothers/sisters showing~     no DA1AT) will be collected.~      Currently, the cohort of patients with DA1AT is being set up in the framework of the Cohort~     DEFI-ALPHA. This multicenter project is realized with the help of french pediatric~     hepatology centers that regularly follow patients DA1AT. Today, over 100 patients DA1AT have~     already been identified, and the collection of historical data has already begun on several~     centers since September 2009. This study is therefore a continuation of this work.~      Over a period of 30 months, the total number of potentially includable subjects is estimated~     at about 400 in this study (100 patients and 300 related to the first degree such as parents,~     brothers and sisters).~      This study will be promoted by the Hospices Civils de Lyon. Authorization of the competent~     authority and the ethical committee will be obtained as well as informed consent from~     families before blood sampling.~   "
130273|NCT01862198|"~     The purpose of this study is to investigate the feasibility and safety of endoscopic~     ultrasound-guided biliary drainage with a newly designed hybrid metallic stent.~   "
130274|NCT01862185|"~     Sepsis is a serious clinical condition with a considerable morbidity and mortality.~     Procalcitonin (PCT) is a good biomarker for early diagnosis and infection monitoring. The~     present study aimed to investigate the effect of semi-quantitative PCT test to the empirical~     antibiotic initiation time, the appropriateness of empirical antibiotics and mortality in~     septic patients.~      The hypothesis of the study are :~        -  There is an effect on mortality between septic patients who do and do not do~          semi-quantitative PCT examination~        -  There is an effect on empirical antibiotic initiation time between septic patients who~          do and do not do semi-quantitative PCT examination~        -  There is an effect on appropriateness of empirical antibiotic between septic patients~          who do and do not do semi-quantitative PCT examination~      Study design is randomized diagnostic trial which is also a pragmatic trial.~   "
130275|NCT01862172|"~     Primary purpose of the trial is to demonstrate the arisen of focal cortical atrophy,~     localized in the ipsilateral primary motor area, measured in mm, three months after~     infarction of internal capsule.~      The patient is compared to himself between day zero to ten and three months.~      The study hypotheses are:~        -  A focal cortical atrophy of the ipsilesional primary motor area occurs after cerebral~          infarction of the internal capsule. It is measurable accurately and reproducibly by MRI~          at three months. Other brain areas within the voluntary motor system will also be~          explored (supplementary motor area, pre motor area).~        -  This atrophy is correlated with achievement of pyramidal tract, assessed by the~          fractional anisotropy of its fibers.~        -  This atrophy is correlated with disability at three months, assessed by Rankin score.~   "
130276|NCT01862159|"~     The rate of serious complications are relatively low in bariatric surgery today, but still~     3-4 % will suffer from a serious complication. There are factors known before the surgery or~     during the operation that are likely to increase the risk for a serious complication. If the~     investigators are aware of these we can optimize the patients risk factors prior to the~     operation or at least increase the awareness of the increased risk in some patients given the~     presence of risk factors.~   "
130277|NCT01862146|"~     Cigarette smoking is the most important modifiable cardiovascular risk factor leading to~     endothelial dysfunction and was suggested to impair arterial regeneration.The aim of the~     study was to investigate the effect of smoking on vascular response to transradial coronary~     angiography (TCA).~   "
130278|NCT01862133|"~     Health information technology, including health information exchange, offers the potential to~     improve care by providing an integrated view of relevant, integrated patient information from~     multiple health care providers practicing in multiple sites. However, realizing that~     potential can be difficult, particularly with respect sensitive information. Increasingly,~     patients, patient advocate groups, and even the National Coordinator for Health Information~     Technology are pushing for patients to have more granular control over specifically who can~     see what personal health information in their electronic health records.~      This will be a demonstration project aimed at showing the initial feasibility a system~     allowing patient controls on their electronic health records. Because of the exploratory~     nature of the research, the investigators do not have specific hypotheses. The investigators~     hope that this demonstration and feasibility project will lead to more extensive prospective~     evaluations of patient control of access to their health records and other tools for~     enhancing patient control over access to their health records.~   "
130313|NCT01861665|"~     The purpose of this trial is to compare incisional pain in patients receiving pre-incisional~     versus post operative Marcaine injection.~   "
130279|NCT01862120|"~     Human recombinant interleukin-2 (rhIL-2) is a biological signalling protein playing a key~     role in the regulation of the immune system. At high doses, rhIL-2 activates the immune~     effectors T cells (TEFFS) while at low doses rhIL-2 induces and activates regulatory T cells~     (TREGS), a population of immune cells controlling the immune Teff response. In patients with~     Type 1 Diabetes (T1D), TREGS fail to control the autoimmune destruction by TEFFS of~     pancreatic beta-cells producing insulin. The investigator recently showed that rhIL-2 at low~     dose is well tolerated in patients with an autoimmune disease and in adults with established~     T1D, inducing TREGS without effects on TEFFS. The investigators aim to use rhIL-2 at low dose~     to induce/stimulate TREGS in young recently diagnosed T1D patients. This study will~     investigate the dose effect relationship of low dose rhIL-2 on TREG induction such as to~     optimize the risk benefit ratio of this treatment in T1D. Through Treg induction, the~     investigators aim to protect the remaining/regenerating pancreatic β-cells from autoimmune~     destruction, thus improving or even curing T1D.~   "
130280|NCT01862107|"~     Background:~      - Cerebrospinal fluid (CSF) is the liquid around the brain and spinal cord. Many diseases can~     only be diagnosed by examining the CSF. A lumbar puncture is used to collect and test CSF.~     Once someone is already having a lumbar puncture, a small extra amount of CSF can be~     collected at the same time. This fluid can be used to study brain, nerve, and related health~     issues. Researchers want to collect CSF and blood samples from people who are scheduled to~     have a lumbar puncture.~      Objectives:~      - To collect cerebrospinal fluid and blood samples from individuals who are having a lumbar~     puncture.~      Eligibility:~      - Individuals between 2 and 100 years of age who are scheduled to have a lumbar puncture for~     clinical or research purposes.~      Design:~        -  Participants will have a lumbar puncture for clinical or research purposes.~        -  During the procedure, an additional sample of CSF will be collected. They will also~          provide a blood sample, if one is not taken at the time of the procedure.~        -  Treatment will not be provided as part of this study.~   "
130281|NCT01862081|"~     This is an open-label, multicenter, dose-escalation study designed to assess the safety,~     tolerability, and pharmacokinetics of oral GDC-0032 administered in combination with either~     docetaxel or with paclitaxel. Patients treated with the GDC-0032 and docetaxel have~     HER2-negative locally recurrent or metastatic breast cancer or non-small cell lung cancer~     (NSCLC). Patients treated with the GDC-0032 and paclitaxel combination have human epidermal~     growth factor receptor 2 (HER2)-negative locally recurrent or metastatic breast cancer. There~     are two potential stages within each arm of this study: a dose-escalation stage (Stage 1) and~     a dose-expansion stage (Stage 2). Once the maximum tolerated dose of GDC-0032 in a given arm~     has been established from dose escalation, additional patients with each combination will be~     enrolled in Stage 2.~   "
130282|NCT01862068|"~     Anti-neutrophil cytoplasm antibodies (ANCA)-associated vasculitis are rare diseases~     characterized by inflammation of blood vessels. Among the numerous cell types that play a~     role in vasculitis, one of the key actors is the neutrophil. Neutrophils are equipped with~     very powerful molecules that they use to destroy the invading microbes. Therefore, the~     mechanisms controlling neutrophil activation should be tightly controlled. If that is not the~     case, neutrophils may destroy the tissues of the host. This is what happens during chronic~     inflammation in vasculitis. Autoantibodies directed against neutrophils, ANCA, produced thus~     demonstrating that neutrophils are also targets of the immune system in these diseases. In~     addition, molecular studies provided evidence that genes normally silenced in mature~     neutrophils under normal conditions can be re-expressed in neutrophils from patients with~     ANCA-associated vasculitis thus strongly suggesting a profound deregulation of neutrophil~     functions in these conditions. Notably, the investigators have preliminary data showing that~     neutrophils from patients with granulomatosis with polyangiitis (GPA, formerly Wegener's~     granulomatosis), an ANCA-associated vasculitis, interfere with the normal phase of resolution~     of inflammation.~      The objective of the investigators' study is to understand the mechanisms underlying this~     increased activation state and determine if neutrophils could be used to define prognostic~     markers by clinicians to optimize patients' care. Therefore, the investigators plan to study~     the expression of proteins implicated in GPA pathophysiology at the membrane of neutrophils~     when they undergo apoptosis. The investigators will also study the deregulation of protein~     expression in neutrophils. This point will be the molecular translation of neutrophil~     deregulation. This technique is powerful and well adapted to identify by mass spectrometry~     the proteins that will be differentially expressed between the control and the disease state.~     After identification of proteins differentially expressed in patients with GPA, the~     investigators will further investigate whether their expression is modulated during the~     disease course and/or modified by the treatment.~      The investigators believe that understanding these neutrophil perturbations can lead to~     better monitoring of disease activity. Ultimately, the investigators may propose more~     targeted anti-inflammatory therapies which would be better tolerated by patients. the~     investigators also can identify new markers for disease activity which allow clinicians to~     define a better therapeutic strategy.~   "
130283|NCT01862055|"~     Spinal anesthesia is the technique of choice for planned cesarean section. It is associated~     with a high frequency of maternal hypotension. Hyperactivity of the sympathetic system~     assessed with the LF/HF ratio (heart rate variability analysis) predicts the severity of~     maternal hypotension after spinal anesthesia. Increased LF/HF ratio may be explained by~     maternal stress that can be measured with salivary amylase. The goal of this study is to~     assess the relationship between salivary amylase and severity of maternal hypotension after~     spinal anesthesia for planned cesarean section.~   "
130284|NCT01862042|"~     The purpose of this study is to evaluate the quality of supportive and palliative care for~     SMA type 1 patients.~   "
130285|NCT01862029|"~     Background:~      - Roflumilast is a drug used to treat chronic obstructive pulmonary disease (COPD). It is~     designed to help reduce lung inflammation. However, during testing, roflumilast also appeared~     to reduce high blood sugar levels in people with COPD and type 2 diabetes. Other tests showed~     that roflumilast also improved blood sugar levels in people who only had type 2 diabetes.~     Researchers want to see how roflumilast affects insulin and blood sugar levels in overweight~     or obese people who are not diabetic, but who have high blood sugar levels.~      Objectives:~      - To see how well roflumilast improves blood sugar and insulin levels in prediabetic~     overweight or obese individuals.~      Eligibility:~      - Individuals between 30 to 65 years old who are overweight or obese (body mass index of 24.9~     to 39.9 kg/m2) and have elevated blood sugar levels.~      Design:~        -  This study will last approximately 8 weeks. Participants will have approximately five~          study visits over about 7 weeks. Two of these visits will be overnight inpatient stays.~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. They will also have a 3-day diet and exercise assessment with~          a dietitian.~        -  In Week 1, participants will have a special diet for 2 days to keep their regular~          weight. They will then have a 2-day inpatient stay. During their stay, they will have~          multiple tests, including blood sugar tests and full body scans. They may provide a fat~          and muscle tissue biopsy sample. They will then receive the study drug to take during~          the study.~        -  In Week 2, participants will repeat the diet study from the screening visit. They will~          receive a different dose of the study drug.~        -  In Week 3, participants will review their diet results and have blood and urine tests.~        -  In Week 5, participants will repeat the diet and exercise study from the screening~          visit.~        -  In Week 6, participants will repeat the inpatient studies and tests from Week 1.~      In the last week, participants will have a final follow-up visit.~   "
130344|NCT01861262|"~     The primary purpose of the protocol is to evaluate the StO2 performance measured at the~     admission to the emergency department to identify hemodynamic failure at the admission or~     within the first three hours of monitoring patients with drug poisoning.~      The study hypotheses are:~        -  The early detection of hypoperfusion by StO2, essential to prevent the development of~          collapse.~        -  To limit hemodynamic failure effects, reduce morbidity and mortality of drug poisoning,~          hospital stay and cost.~   "
130345|NCT01861249|"~     Primary Objective:~      To assess the long term safety and tolerability of SAR339658~      Secondary Objective:~      To assess the long term efficacy of SAR339658~   "
130286|NCT01862016|"~     The care of acute respiratory distress syndrome (ARDS) has been significantly improved by~     learning from experimental and physiological research works and by a series of randomized~     controlled trials. The mortality of this syndrome remains however high. Numerous experimental~     and clinical works demonstrated that a ventilatory mode authorizing the patient to make, from~     the acute phase, spontaneous breathing cycles superimposed on assistance delivered by the~     ventilator (BIPAP-APRV mode) allowed to improve gas exchanges and hemodynamic tolerance of~     the ventilation while reducing the need for sedative drugs. This ventilatory mode could also~     reduce the risk of diaphragmatic dysfunction induced by ventilation. Consequently, our~     hypothesis is that this ventilatory mode could allow a reduction of mortality in ARDS~     patients.~      The aim of this multicenter, prospective, randomized, controlled, open study is to compare~     the effects of two ventilatory strategies on the mortality of ARDS patients and placed under~     mechanical ventilation.~   "
130287|NCT01862003|"~     Recruitment to phase I of the PANTHER trial is complete.~      Phase II, is to evaluate the best overall response rate for AZD8931 + FOLFIRI treatment.~   "
130288|NCT01861990|"~     The study investigates valproic acid added to radiation and temozolomide therapy (standard of~     care) for progressive or recurrent pediatric brain tumors.~   "
130289|NCT01861977|"~     The purpose of this study is to determine the effectiveness of a program to improve habits in~     a population with cardiovascular disease, comparing two different educational techniques~     (cognitive behavioral therapy group vs. informational workshops).~   "
130290|NCT01861964|"~     Human and animal studies demonstrate that xylooligosaccharides (XOS) are a highly efficacious~     prebiotic ingredient that delivers benefits at a minimum level of 1.4 g/day (d), which is~     much lower than levels required by fructooligosaccharides (FOS, 5 g/d) or~     galactooligosaccharides (GOS, 8 g/d). XOS promotes gastrointestinal regularity and relieves~     diarrhea and constipation at 0.7 g/d and 1.4 g/d, respectively. Xylooligosaccharides may also~     reduce blood cholesterol and may improve glycemic control, although more data from clinical~     trials are needed to confirm preliminary findings.~   "
130291|NCT01861951|"~     Patients with a locally advanced or metastatic (i.e., there are already metastases of the~     diagnosed tumor in the body outside the primary lesion) soft tissue sarcoma will be recruited~     for this study. The minimum age to enter the study is 60 years.~      Therapy with doxorubicin is the mainstay of palliative chemotherapy for these patients, which~     is associated with hematological toxicity and an increase of the infection rate. Pazopanib is~     known to rarely induce hematological toxicity or to trigger infection. We therefore assume~     that pazopanib exerts similar activity while decreasing neutropenia and neutropenic fever.~     Pazopanib is already approved in the U.S. and Europe for the treatment of advanced soft~     tissue sarcoma.~      Doxorubicin and pazopanib will be randomly allocated to either receive doxorubicin or~     pazopanib in a phase II clinical trial. The aim of this study is to measure the treatment~     effect (reduction in tumor size or tumor stabilization) for both drugs, as well as the~     survival rate, and the duration of tumor control by the different therapies. A further~     objective is to measure the quality of life by standardized questionnaires throughout the~     course of treatment.~   "
130292|NCT01861938|"~     This study is based on the hypothesis that stimulation of the immune response against the~     tumor can help destroy residual tumor in melanoma patients with very high risk for disease~     recurrence and in patients with relatively low tumor burden who already got first line~     treatment for their disease.~      Ongoing clinical trials in the Hadassah Hospital have shown that vaccination of patients with~     a cell line of tumor cells from the patient himself, or with a combination of three cell~     lines that partially match the patient's cell characteristics, could improve the immune~     response against the tumor, was associated with improved disease-free and overall survival.~      In this study, the investigators will evaluate the efficacy of a modified tumor cell vaccine,~     in terms of immune response,improved disease-free and overall survival. The vaccine consists~     of a cell line that has a high expression level of melanoma molecules, and has been~     genetically modified to induce a strong immune response.~   "
130293|NCT01861925|"~     The purpose of this study is to quantify in-vivo repeatability of a new corneal topography~     measurement mode of an optical biometer, and the clinical performance of measurement in~     comparison to reference devices.~   "
130294|NCT01861912|"~     The purpose of this study is to determine whether compared with arsenic trioxide TACE alone,~     arsenic trioxide TACE and intravenous administration could further prolong the overall~     survival.~   "
130295|NCT01861899|"~     The objective of this study is to gather clinical data on SI-LOK® for the treatment of~     sacroiliac joint dysfunction.~      The purpose of this prospective study is to evaluate clinical and radiographic outcomes,~     intra-operative parameters, patient satisfaction and work status following a procedure using~     SI-LOK® for treatment of sacroiliac joint dysfunction with a minimum of three screws.~   "
130296|NCT01861886|"~     To evaluate the safety and long-term (approximately one year) effectiveness of the Essure~     System for Permanent Birth Control ESS505 device in preventing pregnancy.~   "
130297|NCT01861873|"~     Background: Anatomical (traditional) stereotactic body radio therapy(SBRT) treatment planning~     assumes homogenous distribution of function in the normal liver tissue. In functional~     treatment planning, additional information on distribution of the function derived from~     functional imaging of normal tissue is taken into account. by functional treatment planning~     it becomes possible to prioritize and spare the best functioning part of an organ.~      Aim: To test whether functional treatment planning based on 18-FDGal PET/CT may spare the~     best functioning liver tissue.~      Endpoints: Reduction in hepatic systemic clearance (K) in the dynamic 18-FDGal PET/CT scan~     one month after SBRT compared to the baseline status in sub-volumes recieving 15 Gy or~     higher. Secondly, the investigators will evaluate the toxicity to SBRT by a toxicity scoring~     system that includes biochemical measures as well as symptomatic scores.~   "
130298|NCT01861860|"~     Rationale IVUS has shown to be efficient for bare metal stent deployment, but has not been~     specifically studied for Drug Eluting Stents. The angiographically versus IVUS optimization~     (AVIO) study was performed with (medical device's type )Promus stent, results are promising,~     but the study was not designed for clinical endpoint.~      There is no consensus on IVUS criteria for stent deployment. The MUSIC criteria were widely~     used in the early 2000, but have limitations for complex long lesions. The AVIO criteria were~     recently proposed for complex lesions, but these criteria also have some issues and the~     complexity make their routine use challenging.~      We performed a pilot study for long complex lesion analysis using IVUS, in order to define~     easy to use criteria, applicable for complex lesions in drug eluting stents (DES) era. The~     new criteria (OPERA) are an adaptation of the MUSIC criteria.~      OTELLO study is an ongoing trial sponsored by Boston Scientific Inc, to determine Major~     Adverse Cardiac Event with the new TAXUS Element stent. 500 patients will be enrolled in the~     study.~      Main question Is IVUS using simplified new criteria beneficial for long (>28mm) TAXUS element~     stent deployment?~      Study design This study will consist to prospectively include consecutive patients with>28mm~     taxus element stent using IVUS. OPERA Criteria for stent deployment will be the objectives to~     reach. OPERA is an adaptation of the MUSIC criteria for long complex lesion. The patients~     from the OTELLO study, with the same inclusion criteria, will composed the control group .~     Population will be matched using the propensity score.~      20 to 30 French centers involved in OTELLO study will be contacted for participating in~     OPERA.~      Hypothesis:~      Long lesion percutaneous coronary intervention(PCI) have specific characteristics like~     Diffuse old atheroma Calcifications Discrepancies between prox and distal diameter~     Infiltration longer than the target lesion Bifurcations Inhomogeneous strength due to the~     balloon (Laplace law) Primary hypothesis Long Taxus element deployed using IVUS and OPERA~     criteria have better outcomes than without IVUS~      Primary Objectives 38% MACE (SAT, target lesion revascularization (TLR), myocardial~     infarction (MI), Death) reduction using IVUS and OPERA criteria for Taxus element ≥ 28 mm~     implantation~      Secondary endpoint~        1. MACE determination for Taxus element ≥ 28 mm implantation with IVUS and OPERA criteria~        2. Safety: procedural Stroke, Urgent cardiac surgery, procedural MI~        3. Comparison of IVUS criteria: OPERA, MUSIC, AVIO~      Secondary objectives Safety of OPERA criteria Feasibility of using OPERA criteria in non~     expert IVUS center MACE determination with a 4% margin error for Taxus element ≥ 28 mm~     implantation with IVUS and OPERA criteria~      Methods Inclusion of consecutive patients using IVUS Taxus element ≥ 28 mm in a multicentric~     study propensity score matched analysis matched for comparison to OTELLO study. (Same~     inclusion criteria as OTELLO)~      Statistical analysis Primary Endpoint: MACE expected in the OTELLO study=18% MACE expected in~     the OPERA study=11% Number of patient in the OTELLO study=500 Alpha=0.05,1- Beta=0.73 Number~     of patients analysable in the OPERA study needed =250 patients i.e 300 pts inclusions.~      Secondary Endpoint 4% margin error with a MACE of 11% need also 250 pts~      Type of study Biomedical research French study Centralized IVUS analysis 1, 6 and 12 months~     telephone contact~      Safety and efficacy measures Efficacy: MACE (Cardiac Death, target vessel revascularization~     (TVR), Myocardial Infarction) at 12 months Safety: procedure related event: Urgent surgery,~     According to Good Clinical Practices serious adverse event (SAE) declared within 24 Hours~   "
130299|NCT01861847|"~     The purpose of this research study is to test the effectiveness of 7-Keto DHEA in reducing~     symptoms of Post-Traumatic Stress Disorder (PTSD).~   "
130300|NCT01861834|"~     To provide children dependent on total parenteral nutrition with Omegaven®, a fish oil-based~     intravenous lipid emulsion that may be less hepatotoxic than conventional, vegetable~     oil-based intravenous lipid emulsions, and that may therefore reduce the need for liver~     transplantation.~   "
130304|NCT01861782|"~     Prospective open label crossover self controlled study. The study population will randomly be~     divided into two groups.~      The study will take place in Lot Spa Hotel at the Dead Sea in two cycles (one of 16~     participants and one of 14 participants) and will be comprised of 3 main stages:~        1. Initial exposure to treatment for 14 days excluding Friday and Saturday (each of the two~          groups will have its own treatment protocol)~        2. 12-month washout period~        3. Crossover of the two groups and second exposure to treatment for 14 days excluding~          Friday and Saturday (each of the two groups will have its own treatment protocol).~      The population in the study will be composed of patients diagnosed and treated for rheumatoid~     arthritis at the Soroka University Medical Center who are 18 and above of age.~      The patients will be selected by the PI and his team and addressed regarding their~     willingness to participate in the study.~   "
130305|NCT01861769|"~     Approximately 9% of Canadians will have Posttraumatic Stress Disorder (PTSD) in their~     lifetime. In the military veteran population, the lifetime prevalence of PTSD has been~     estimated to be as high as 20%. Numerous research studies have demonstrated that short-term,~     cognitive-behavioral psychotherapies, such as Cognitive Processing Therapy (CPT), lead to~     substantial improvements in PTSD symptoms. However, research suggests that a minority of~     clinicians provide these therapies in clinical settings. The transfer of this research~     knowledge into clinical settings remains one of the largest hurdles to improving the health~     of Canadians with PTSD.~      It is well established that attending a 2-day workshop on these therapies alone is~     insufficient to promote adequate knowledge transfer and sustained skillful use. The current~     study aims to contrast whether two forms of post-workshop support (6-month duration), with~     different levels of expert oversight, will result in superior levels of clinician skill and~     patient outcomes versus no formal post-workshop support. The three forms of post-workshop~     support are 1) technology-enhanced group tele-consultation 2) standard group~     tele-consultation 3) no tele consultation. The primary and secondary outcomes will be the~     assessment of the clinicians' competence in CPT and patient symptoms,respectively. This study~     will inform how best to transfer evidence based therapy outcomes to the clinical milieu to~     attain comparable outcomes as those observed in research.~      The investigators' hypotheses are as follows: Hypothesis 1:The technology enhanced group~     tele-consultation condition will evidence the highest levels of fidelity, the standard group~     tele-consultation condition will evidence intermediate levels of fidelity, and the~     no-consultation/fidelity monitoring only condition will evidence the lowest fidelity.~     Hypothesis 2: Fidelity to the CPT protocol, irrespective of consultation condition, will be~     positively associated with improved client outcomes. Hypothesis 3: Organizational context~     variables, such as the organizational climate and readiness for change, will influence the~     uptake of CPT skills, as well as the extent to which these skills are utilized in practice.~   "
130306|NCT01861756|"~     A cluster randomized trial to assess the efficacy of the Diabetes Medication Choice decision~     aid among Greek patients with type 2 diabetes mellitus compared with usual care. The tool~     will serve as a facilitator for the Shared Decision Making process.~   "
130307|NCT01861743|"~     Most patients undergoing surgery experience significant post-operative pain. Inadequate~     peri-operative pain management may decrease post-operative mobilization and increase length~     of hospitalization. Additionally, poorly managed acute post-operative pain analgesia is~     associated with an increased risk of developing chronic pain and delayed wound healing.~      Lumbar spine surgery is particularly painful, often requiring a multi-day hospitalization.~     The most common post-operative analgesia used in spine surgery is narcotic medication~     delivered via an intravenous patient controlled analgesia (IV PCA).~      A multimodal peri-operative pain management protocol for spine surgery has the potential to~     not only decrease pain but also to improve recovery, decrease narcotic consumption, decrease~     length of stay in the hospital and reduce both direct and indirect hospital costs.~      The purpose of this study is to determine if post-operative pain and rate of recovery are~     improved in patients undergoing spine surgery using MMA compared to usual analgesic care.~   "
130308|NCT01861730|"~     Phase I/II, randomized, double-blind, placebo-controlled, safety, immunogenicity and~     dose-range finding study of AERAS-404 Tuberculosis (TB) vaccine administered intramuscularly~     in Bacille Calmette-Guerin (BCG) primed infants.~   "
130309|NCT01861717|"~     If someone is diagnosed with a pituitary tumor that causes acromegaly (too much growth~     hormone) the treatment is to have it surgically removed. This study has two phases.~      The first phase provides medical treatment with a drug that will be provided for 3 months~     before surgery to see if complications of surgery are reduced and to see whether or not~     remission improves following surgery if you have this medical treatment. The drug~     administered is approved by the FDA for long-term treatment of acromegaly. It is not~     routinely administered before surgery, and is therefore experimental as used in this way. All~     other procedures performed during this research are standard of care with the exception of~     the 3 questionnaires to be completed at each visit.~      The second phase of this study is from 3 months until 12 months after surgery and is only for~     people who do not go into remission after the operation. This phase assesses the possible~     remission of acromegaly after resuming the drug treatment for an additional 3 to 9 months.~     The drug will be prescribed by your physician as part of your regular medical care and will~     not be included as part of the study. All other procedures performed during this research are~     standard of care with the exception of the 3 questionnaires to be completed at each visit.~      The study lasts approximately 16 months - 3 month before surgery and 12 months after surgery.~   "
130310|NCT01861704|"~     Randomized post market study comparing Lyric to Lyric2 capturing information regarding~     comparative performance and safety.~   "
130311|NCT01861691|"~     The long-term results of several large-scale prospective randomized trials that compared~     laparoscopic-assisted and open colectomy for colon cancer were published in the past decade.~     The oncologic outcomes were nearly similar in patients who underwent laparoscopic or open~     surgery. In Japan, the Japan Clinical Oncology Group (JCOG) conducted a randomized trial to~     compare oncological outcomes between patients who underwent laparoscopic or open surgery for~     advanced colon cancer and recto-sigmoid cancer. However, the exclusion criterion were~     concerning tumor site in transverse and descending colon. The reason of exclusion was that~     laparoscopic procedure was difficult in transverse and descending colon cancers. However,~     laparoscopic surgery for transverse and descending colon cancer was performed clinically. We~     conducted a randomized trial that compared laparoscopic surgery and conventional open surgery~     in in transverse and descending colon cancer. The purpose of the present study was to clarify~     the safety and feasibility of laparoscopic surgery on in transverse and descending colon~     cancer patients.~   "
130312|NCT01861678|"~     The tying at a radix of the inferior mesenteric artery (IMA) is recognized as radical cure~     technique in a rectal cancer surgery in Japan. In one side, the preserving the left colic~     artery (LCA) that is the technique to maintain blood flow of proximal sigmoid colon is~     performed in practice. However, there is no evidence that shows effectiveness of this~     technique.~      We conducted a randomized trial that compared between high tie and low tie of the IMA in~     rectal anterior resection to define an appropriate portion of IMA tying.~   "
130314|NCT01861652|"~     Restless legs syndrome (RLS) is a debilitating sleep disorder that has significant impact on~     quality of life, and often times can be difficult to diagnose and treat effectively. RLS is~     typically treated with medical therapy (including dopaminergic agents, dopamine agonists,~     benzodiazepines, anticonvulsants, opiates, among other therapies). Many patients are either~     refractory to medical therapy, have contraindications or adverse reactions to the available~     medical therapies, or desire conservative non-medication based therapies. Two previous~     studies have demonstrated that pneumatic compression devices placed on the legs can improve~     symptoms of RLS. We would like to assess whether the Venous Health Systems Vasculaire leg~     compression device improves symptoms and quality of life measures related to RLS in up to 40~     patients evaluated prospectively for one month. This is a pilot study to assess the~     subjective response of our cohort of patients to this device prospectively. Our hypothesis is~     that over 66% of our cohort will demonstrate a positive symptomatic response based on RLS~     specific quality of life questionnaires.~   "
130315|NCT01861639|"~     Episodic and working memory processes are the most affected cognitive domains in Alzheimer's~     Disease (AD) and its early stage, Mild Cognitive Impairment (MCI).~      Transcranial Magnetic Stimulation (TMS) is a unique tool to interfere with cognitive~     processes by inducing virtual and transient lesions, mimicking those observed in MCI. It~     has proven repeatedly its capacity to interfere with encoding-retrieval memory task. However,~     to date, only few imaging data exist on the cerebral pathways involved in encoding memory~     task. Moreover, the stability of TMS effects over time remains to be investigated. If proven~     to be a stable interfering challenge, TMS could be used to investigate the potential~     restoring effect of new medication in AD.~      The study is the pilot study of a larger clinical trial which aims to prove the utility of~     rTMS as a potential model for prediction of clinical efficacy using a combination of~     cognitive and neuroimaging endpoints.~   "
130316|NCT01861626|"~     The purpose of this study is to evaluate the bioequivalence (comparison of the rate and~     extent of the active substance into the body following single administration of the drugs)~     between the test product V0057 and a reference product after two single oral administration~     separate by 7 days.~   "
130317|NCT01861613|"~     At present, children less than 15 y of age have been regarded as a key group for hepatitis B~     immunization in China. However, there is not yet special immunization strategy for population~     above 15 y of age. In this study, we investigated the seroprevalence of hepatitis B and~     immune response to HB vaccine among Chinese college students to uncover the need on universal~     mass vaccination or booster immunization only for students with HBV vaccination history~     against hepatitis B in Chinese college students to inform decision making.~   "
130318|NCT01861600|"~     The primary efficacy objective was to determine and compare stool composition (stool soap and~     non-soap fatty acids, total fatty acids, minerals, and other stool constituents) among the~     feeding groups.~   "
130319|NCT01861587|"~     The purpose of this study is to determine whether a new medical technology can help reduce~     post-operative pain. The new technology is called Transcranial Direct Current Stimulation.~   "
130320|NCT01861574|"~     The purpose of this research study is to investigate the effects of Transcranial Magnetic~     Stimulation on pain perception. TMS is a non - invasive technique that uses electromagnetic~     pulses to temporarily stimulate specificc brain area in awake people ( without the need for~     surgery, anesthetic, or other invasive procedures.~   "
130321|NCT01861561|"~     Proliferative lupus nephritis (LN)is the predominant cause of morbidity and mortality in~     juvenile Systemic Lupus Erythematosus (SLE). Induction therapy with high-dose intravenous~     cyclophosphamide can improve renal outcomes, but considerably associated with infection.~     Although severe infection is the significant complication related to poorer prognosis for~     juvenile SLE patients in Asia, cyclophosphamide is still commonly used as the drug of choice~     for severe lupus nephritis. Euro-Lupus Nephritis Trial demonstrated low-dose intravenous~     cyclophosphamide regimen followed by azathioprine achieved good clinical results comparable~     with obtained high-dose regimen. There was lower number of severe infection episodes, but no~     significant difference. Recent studies applied low dose of cyclophosphamide (500 mg/m2/dose~     or 500 mg/dose)in young patients and showed good renal response. Low-dose intravenous~     cyclophosphamide regimen might promote non-inferior renal remission whereas decrease risk of~     serious infection and improve overall patient outcomes.~   "
130322|NCT01861548|"~     The Polish Mother and Child Cohort is multicentre prospective study on different exposures.~      Prospective cohort study design enables identification of exposures that may influence~     pregnancy outcome and chil-dren's health, verification of such exposures by biomarker~     measurements and notification of any changes in exposure levels.~      The aim of the study is to evaluate the impact of exposure to different environmental factors~     during pregnancy and after birth on pregnancy outcome and children's health. Specific~     research hypotheses refer to the role of heavy metals, exposure to polycyclic aromatic~     hydrocar-bons (PAHs) and environmental tobacco smoke (ETS) in the aetiology of intrauterine~     growth retardation (IUGR), preterm delivery (PD) and the risk of respiratory diseases,~     allergy and poor mental and physical development. It is also intended to explain the role of~     oxidative stress and nutritional status of the pregnant women. The impact of occupational~     exposures and stressful situations on pregnancy outcome will be evaluated from question-naire~     data.~      The results of the study will help to determine levels of child prenatal and postnatal~     exposure in several areas of Poland and their im-pact on course and outcome of pregnancy and~     children's health.~      This protocol concerns the children that are followed-up from birth to the age of 2 years to~     determine long term effects of pre- and postnatal environmental exposures.~   "
130323|NCT01861535|"~     To evaluate the efficacy (defined as complete clinical response at 6 months) of imiquimod vs.~     standard treatment (surgery) for vulvar intraepithelial neoplasia (VIN).~   "
130324|NCT01861522|"~     The objectives of this study are: to confirm the superiority of TAU-284 over placebo after~     two weeks of administration to pediatric patients with perennial allergic rhinitis and to~     investigate safety of TAU-284.~   "
130325|NCT01861509|"~     This study is an open label, non-randomized phase I single-armed study in women with~     metastatic breast cancer (MBC) who have previously undergone all available standard~     chemotherapy regimens. The purpose of the study is to estimate the pharmacokinetics (PK)~     after single dose and multiple dose of BP-C1, investigate interleukin levels during BP-C1~     treatment and assess treatment response according to RECIST criteria.~   "
130326|NCT01861496|"~     Liposomal formulations are frequently used today in the treatment of cancer. LiPlaCis is the~     first targeted liposomal formulation with a tumour triggered release mechanism to undergo~     clinical development in oncology and it is expected that LiPlaCis will improve the~     therapeutic index of cisplatin compared to conventional cisplatin.~      Cisplatin is one of the most widely used drugs in the treatment of cancer due to its~     documented efficacy in a number of tumour types. Furthermore, it seems highly likely that~     cisplatin will remain an important drug in the future treatment of cancer. However, the drug~     is associated with a number of serious toxicities that complicates or necessitates~     discontinuation of therapy - e.g. need for pre-hydration, neurotoxicity, nausea and vomiting.~      Thus, there is a well-established need for improving cisplatin therapy in cancer patients.~     One option here is improving the formulation of the drug, so that a more selective up-take of~     cisplatin administered takes place at the tumour sites.~      Based on the results of the pre-clinical studies of LiPlaCis, it seems clear that LiPlaCis~     offers the potential to improve cisplatin therapy to the benefits of cancer patients.~      In a prematurely stopped Phase I Dutch study a Recommended Dose (RD) for a Phase II study was~     never reached which was the aim of the finished Phase I dose escalating part of this study~     for advanced or refractory solid tumors.~      In the Phase 2 part of this study, patients with advanced breast cancer with a biopsy~     examination showing a pattern compatible with sensitivity to LiPlaCis or patients with skin~     cancer will be included.~   "
130327|NCT01861483|"~     To investigate the vessel resection and reconstruction in biliary tract cancer.~   "
130328|NCT01861470|"~     More than 8000 babies born >8 weeks early or weighing less than 1500g at birth in the United~     Kingdom annually are at risk of a serious eye problem - retinopathy of prematurity (ROP).~     Less than 1 in 10 need treating, but to identify these all of them require eye examinations~     1-2 weekly from 5 weeks. These tests are uncomfortable, upsetting for families, and cost~     considerable time and money.~      There is now a new urine test that might help identify babies with the highest risk of~     developing significant ROP. This cheap test appears to predict which babies need treatment~     and could avoid invasive eye examination in thousands of babies. The test has so far only~     been used in 136 babies. It accurately predicted ROP, but 136 babies cannot change practice.~     We need to test more babies including in the UK. This study is designed to test >300 UK~     babies to see how accurately urine levels of NTproBNP predict development of ROP needing~     treatment.~      We will also pool our data with other researchers across Europe testing the same test to~     identify the best 'cut'-off' value for this test. In the future babies with urine levels of~     this chemical lower than this cut-off level would not need invasive eye examinations.~      If this test works as we hope it will many babies will avoid repeated painful eye tests, and~     their families will be saved the stress of watching this being done, by replacing these with~     a simple easy cheap pain free urine test. There will be substantial savings in health care~     costs that could be used to improve other aspects of care. In resource poor settings without~     an expert ophthalmologist babies could be screened for ROP that currently cannot be screened.~      We hope to demonstrate this to be a family-friendly, achievable intervention that positively~     impacts on the lives of babies and families experiencing neonatal intensive care.~   "
130329|NCT01861457|"~     The purpose of this study is to determine the extent to which bacterial growth in the~     nostrils by S. aureus, a common bacteria that is found in hospital environment, can be~     reduced by NOZIN® Nasal Sanitizer® antiseptic nasal swabs during the course of a typical~     10-hour work period in participants known to have S. aureus in their nose passages.~   "
130330|NCT01861444|"~     This prospective, multicenter, observational study will assess the prevalence of chronic~     hepatitis D in patients with chronic hepatitis B in Romania and evaluate the efficacy of~     Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis D. Eligible patients~     treated with Pegasys according to current medical practice will be followed until 24 weeks~     after the end of treatment.~   "
130331|NCT01861431|"~     The proposed study aims to test the feasibility and preliminary efficacy of a combined~     4-session HIV sexual risk reduction (HIVSRR) and microfinance intervention (including 34~     training session and matched savings) to reduce unprotected sex and to increase proportion of~     income from sex work among women engaged in high risk sexual activity in Ulaanbaatar,~     Mongolia. Feasibility and preliminary efficacy will be tested using a randomized clinical~     trial (RCT) with 134 women sex workers meeting eligibility criteria. Following eligibility~     screening, eligible women will complete informed consent, a baseline assessment, and be~     randomized to one of 2 study conditions: 1) the combination HIV sexual risk reduction plus~     microfinance (HIVSRR+MF); or 2) a 4-session HIVSRR alone control condition.~      The study design will permit us to:~        1. Examine and enhance the feasibility (i.e. recruitment, engagement, attendance, retention~          data collection) of a combination HIV sexual risk reduction and MF intervention with~          high risk women in Ulaanbaatar, Mongolia;~        2. Examine the preliminary outcomes of the interventions on decreasing unprotected acts of~          vaginal and anal intercourse; increasing the proportion of protected vaginal and/or anal~          acts using barrier protection and decreasing number of sexual partners with repeated~          measures at baseline, immediately post-intervention, and 3 and 6 month follow-up~          assessments.~        3. Use the results of the pilot study to inform the design of a future R01 application.~   "
130332|NCT01861418|"~     The purposes of this study are:~        1. To examine the within-day and between-day test-retest reliability of a testing protocol~          measuring the back and hip muscles fatigability using EMG median frequency~        2. To examine the immediate and the carry-over effects of the lumbopelvic manipulation on~          the EMG median frequency of the lumbar multifidus (MULT), gluteus medius (GMED) and~          gluteus maximus (GMAX) muscles in patients with chronic low back pain (CLBP)~        3. To compare the fatigability levels of the MULT, GMED and GMAX muscles by measuring the~          EMG median frequency between the participants who will receive lumbopelvic manipulation.~      The research hypotheses are:~        1. The testing protocol using EMG median frequency as a fatigue indicator for MULT,GMED and~          GMAX muscles will have good (ICC ≥ 0.80) within-day and between-day test-retest~          reliability.~        2. The fatigability level of the MULT, GMED and GMAX muscles will significantly decrease~          immediately after the lumbopelvic manipulation and will be maintained over two to four~          days following the manipulation.~        3. The fatigability of the MULT, GMED and GMAX muscles will significantly decrease after~          the intervention in the manipulation group while no change will occur in the placebo~          group.~   "
130346|NCT01861236|"~     Prospective, observational study to collect and analyze data on patients with advanced~     hormone dependent prostate cancer treated with Firmagon® according to routine medical~     practice in Argentina~   "
130347|NCT01861223|"~     To find the optimal dose of afatinib and nimotuzumab in patients who acquired resistance to~     gefitinib or erlotinib.~   "
130333|NCT01861405|"~     The investigators seek to perform an observational study in patients with brain metastases~     that are to undergo whole brain radiation therapy (WBRT) or stereotactic radiosurgery (SRS)~     treatment in order to quantify any baseline neurocognitive changes which may result from~     intracranial disease burden, from radiation treatment (WBRT or SRS), or both. To do so, the~     investigators will compare matched control subjects to patients at time points obtained~     before and after radiation treatment with either SRS or WBRT. Pre-treatment evaluation will~     include neurocognitive testing and an assessment of fMRI task-related activation patterns and~     resting state brain activity. Four and twelve month post-treatment neuropsychological~     evaluations will be performed and pre- and 4-month post-treatment fMRI scans will be obtained~     in order to evaluate changes in neurocognitive functioning with a focus on short-term memory~     and executive function domains. A brief quality of life assessment will also be completed at~     each study time point. In order to plan treatment strategies in the future it is important to~     accurately document the effects of intracranial disease burden as well as radiation treatment~     on neurocognitive functioning, validate fMRI activation tasks for short term memory and~     executive functioning, and quantify the activation volumes that would potentially be spared~     in future cognitive sparing protocols.~      The investigators hypothesize first that the amount and location of intracranial disease~     burden will represent pre-treatment variables that affect NCF. The compromised NCF will be~     visualized in both the resting state and task-oriented neurocognitive exercise. The~     investigators anticipate that any perturbation in resting state caused by intracranial~     disease burden should be reflected in patients when compared to matched controls.~      The investigators hypothesize additionally that cancer patients with brain metastases~     undergoing radiation treatments will have improved intracranial disease control at the~     expense of executive and memory function with differences between patients that undergo~     stereotactic radiosurgery or whole brain radiation alone.~   "
130334|NCT01861392|"~     Background: The individual's ability to sustain itself in the upright position, effectively~     adjusting the body's movements and reacting to external stimuli, postural control strategies~     represent essential activities of daily living. Diabetes mellitus type 2 (DM-2) is considered~     a more problem of Public Health as having complications deficit in functional performance of~     the lower limbs and falls, which can interfere with the maintenance of balance, and is a~     strong predictor of functional limitations self referred. Aim: To assess quality of life and~     the answers neuromuscular balance and baropodometric after sensory-motor training in patients~     with type 2 diabetes. Method: To be recruited 50 volunteers aged between 45 to 64 years with~     DM-2, of both sexes, divided into two groups: 1) Guidelines and 2) Guidelines + sensory-motor~     training. Biomechanical data will be collected (balance, baropodometry, electromyography~     strength and joint position sense), as well as questionnaires ADDQoL and BESTest. The~     intervention will be twice a week for 45 minutes for 12 weeks, divided into three phases:~     heating, sensory-motor training and cool-down, with monitoring of blood pressure and blood~     glucose. There will be a follow up after 3 months of intervention. Statistical analysis will~     be used normality test to verify the data distribution and consistent statistical test for~     the appropriate comparisons within and between groups, and adopted a significance level of~     5%. Expected Results: Considering previous studies that demonstrate improvement in postural~     balance static and dynamic responses under the forward training protocol sensorimotor disease~     Diabetes mellitus type 2, is expected to improve neuromuscular, balance, distribution plant,~     the joint position sense and the quality of life of voluntary DM-2.~      Keywords: physical therapy modalities, exercise therapy, postural balance, Diabetes Mellitus,~     quality of life.~   "
130335|NCT01861379|"~     To evaluate if the Ghost Ileostomy is really advantageous in laparoscopy we conducted a~     prospective randomized controlled study comparing 2 groups of patients undergoing anterior~     resection of the rectum laparoscopically. In the first group of patients at the end of the~     procedure was always performed a Ghost Ileostomy while in the second group no protective~     stoma was built at the end of the intervention.~   "
130336|NCT01861366|"~     The aim of this study is to examine two implementation strategies (external facilitation and~     educational outreach visit) when introducing nutritional guidelines in the elderly care~     setting and to evaluate the results of the implementation by clinical outcome measures of the~     nursing home residents.~      The hypothesis is that the residents affected by the external facilitation strategy will stay~     stable in the measured clinical outcomes, while the residents influenced by the educational~     outreach visit will deteriorate during the implementation process.~   "
130337|NCT01861353|"~     Cranberry and cranberry-lingonberry juice prevented urinary tract infections in children and~     in adults in our earlier clinical trials. The preventive effect was, however, observed late~     in the follow-up and the next recurrence was not prevented in children. The investigators~     hypothesize that cranberry-lingonberry juice should be started already during the~     antimicrobial treatment of acute urinary tract infection in order to maximize the preventive~     efficacy of the juice. In addition, the investigators aim to find the explanation for the~     efficacy of cranberry-lingonberry juice by analyzing the concomitant changes in the chemical~     composition of urine and feces as well as the changes of gut microbiota.~   "
130338|NCT01861340|"~     This research study is being done to see if combining the investigational chemotherapy drug,~     MEDI-551 with the known anti-myeloma drugs, Lenalidomide and Dexamethasone will reduce your~     myeloma cancer stem cells.~   "
130339|NCT01861327|"~     Prospective randomized comparison between endovascular procedures performed with iodinated~     contrast or carbon dioxide as intraarterial contrast.~   "
130340|NCT01861314|"~     This phase I trial studies the side effects and the best dose of bortezomib and sorafenib~     tosylate when given together with decitabine in treating patients with acute myeloid~     leukemia. Bortezomib and sorafenib tosylate may stop the growth of cancer cells by blocking~     some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as decitabine,~     work in different ways to stop the growth of cancer cells, either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading. Giving bortezomib and~     sorafenib tosylate together with decitabine may work better in treating acute myeloid~     leukemia.~   "
130341|NCT01861301|"~     This phase II trial studies how well tivantinib works in treating patients with previously~     treated malignant mesothelioma. Tivantinib may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth.~   "
130342|NCT01861288|"~     We hypothesize that the number of needed endoscopic procedure performed at IBD patients~     (adult and children), can be reduced by using an individualized algorithm of symptoms, blood~     and faecal biomarkers.~      The aim of the study is to reduce the numbers of endoscopies, as the procedure is~     uncomfortable for the patient, time consuming and expensive. Through indirect tests - blood~     test, fecal inflammation marker and clinical symptoms - compared to endoscopic findings, we~     want to construct an algorithm by which the intestinal healing can be foreseen without~     performing an endoscopy.~      Furthermore, we will correlate FC, blood tests, clinical symptom score and endoscopic score,~     with the histo-pathological inflammation score from intestinal biopsies and the immunological~     score depicted by TNF- alpha and IL17A levels in intestinal tissue, in order to assess the~     gold standard - endoscopic remission.~   "
130343|NCT01861275|"~     Obstructive sleep apnoea is a risk factor for ischaemic stroke. study hypothesis: In~     prospective study the investigators want to know how many ischaemic stroke patients have~     sleep apnoea and does thrombolysis play a role in severity of osa in six months follow up.~   "
133587|NCT01818739|"~     This clinical trial studies lymph node mapping in patients with endometrial cancer. Lymph~     node mapping may allow for limited removal of lymph nodes in as part of endometrial cancer~     staging and treatment.~   "
130348|NCT01861210|"~     This is a study to determine whether testing for HIV together as a couple, as opposed to~     testing separately, in acceptable to men in male couples, and is a safe prevention service.~     Testing of couples together has been provided for decades in Africa, but has never been~     tested in the United States. In this study, male couples will be enrolled and randomly~     assigned to be tested together in the same room, or separately. At the time of testing,~     investigators will ask questions about how they felt about the service they received. Three~     months later, investigators will survey the men again, and determine whether they had any~     problems after the testing, like violence in the relationship or the relationship breaking~     up. The main outcomes are being satisfied with the testing service, and safety (lack of~     intimate partner violence or relationship termination). Although the study is not designed to~     determine if the service reduces risk behaviors for HIV transmission, investigators will~     examine data on risks just to explore that topic. The main hypotheses are: (1) men will be at~     least as satisfied with couples testing as they are with individual testing; and (2) men~     tested as couples will not experience higher rates of intimate partner violence or~     relationship dissolution, relative to men tested separately.~   "
130349|NCT01861197|"~     Efficacy of Dovitinib for Squamous NSCLC.~   "
130350|NCT01861184|"~     We are interested in developing new and better ways of diagnosing the cause of lower~     respiratory tract infections including pneumonia. Currently we find the causal bug (bacteria~     or virus) in less than 50% of patients with pneumonia. A potential way to better find the bug~     responsible may include checking for bugs in the nose by a nasal wash or swab. Better~     diagnostics would allow more targeted antibiotic therapy and in the future this technique may~     be used as a way of checking the efficiency of new vaccines.~      We are recruiting both patients with respiratory infections and also a 'control' group of~     patients admitted to hospital who do not have respiratory infection. We need to have access~     to your medical history information to make sure you are eligible and suitable for the study.~     If you participate in the study, it is important that the study doctors continue to have~     access to your personal Investigator Designation Contact telephone Dr Andrea Collins PhD~     student/research SpR xxxxxxxxxxxxx Carole Hancock Research nurse 0151 706 4856 Prof Stephen~     Gordon Principle Investigator 0151 705 3169 NW PIL V1.3: October 2012 REC ref: 12/NW/0713~     information so you can be followed up properly and so we can contact you during the study if~     needed.~      Patients in both groups will have a nasal wash (or swab), blood (30mls = 6 teaspoons) and~     urine taken on the day of recruitment and a nasal wash (or swab) and blood (30mls = 6~     teaspoons) taken 6 weeks later (this is likely to be as an out-patient at the Royal~     Liverpool, in extreme circumstances this will occur at the patient's home).~   "
130351|NCT01861171|"~     The purpose of this study is to evaluate the effects of green tea on body weight, waist~     circumference, metabolic profile, inflammation, blood pressure and endothelial function in~     obese pre-hypertensive women.~   "
130352|NCT01861158|"~     This study evaluates Parenting Wisely (PW), an interactive, computer-based, online parenting~     program, through a formal randomized trial conducted in collaboration with the juvenile~     justice system (JJS), the primary market for such a program. Parents of 450 delinquent~     receiving JJS services as usual (SAU) will be randomly assigned to: PW plus a social~     networking online discussion forum, PW alone, or SAU. The investigators will also determine~     the potential marketability of the PW intervention to JJS programs based on the effects of PW~     on parent report and direct observation measures of parenting behaviors, adolescent~     behaviors, and family functioning, as well as measures of recidivism and cost savings. User~     satisfaction, program comprehension, receptivity, and parent self-efficacy will also be~     assessed. The investigators hypothesize that the two PW interventions (PW only and PW +~     Social Network) will produce greater reductions in disruptive behavior problems from baseline~     to 3- and 6-month assessments compared to SAU.~   "
130353|NCT01861145|"~     Enuresis (E) or bedwetting is a common pediatric complaint, and recent research has~     discovered a link with obstructive sleep apnea (OSA). In children, OSA is often secondary to~     enlargement of their adenoids or tonsils, and is often successfully treated with a steroid~     solution given through the nose.~      The relationship between SDB and E is incompletely understood. Airway obstruction affects the~     quality of sleep, as the child will wake as the oxygen levels drop. Abnormal sleep also can~     decrease the secretion of hormones that affects the kidney's ability to concentrate urine at~     night, which can result in too much urine in the bladder. Contemporary evidence also suggests~     that patients with enuresis have abnormal sleep phases, which may impair the communications~     and inhibition of the bladder.~      In previous studies, the investigators have demonstrated that children with E have a high~     likelihood of having concomitant SDB. The investigators have also demonstrated that children~     with E and symptoms of SDB do not respond to typical management for bedwetting. Therefore,~     the investigators propose to treat patients presenting with E with our standard treatments~     for E (bed alarm) and first line therapy for SDB: Intranasal steroids. This medication helps~     to decrease the inflammation of the adenoids and tonsils, thereby reducing the airway~     obstruction. the investigators hypothesize that children with significant symptoms of SDB~     will improve with the addition of INS, and the investigators hope to see an improvement in~     their bedwetting, quality of life, and sleep quality as well.~      To test this, patents with E will be recruited from the pediatric urology clinic. They will~     be offered the standard treatment for E, the bed alarm, and the treatment group will be given~     an intranasal steroid spray. The investigators will then reassess the patients 3 months after~     treatment, and compare the two groups.~   "
130354|NCT01861132|"~     Blood pressure and cardiac output can be measured invasively in pregnant women. Non-invasive~     monitoring devices are desirable, but until now, no equipment has proven validity. This study~     aims at validating the non-invasive monitoring device NexFin (second generation Finometer) in~     pregnant women.~   "
130355|NCT01861119|"~     Hypertrophic or keloid scars develop for about 39% to 68% of patients after surgery. The~     subjective opinion of the patient regarding the scar will often constitute the standard for~     judging the success or failure of the procedure. Surgical scars are not only a cosmetic~     concern but they can also cause pain, itching, discomfort, contracture, and other functional~     impairment. Various treatment options exists for treating hypertrophic scars and keloids,~     including intralesional steroid injection, dermabrasion, pressure therapy, surgical excision,~     radiotherapy, cryotherapy, pulse dye, and carbon dioxide laser ablation. However, these~     treatments often require multiple visits and have limited success. Therefore, prevention and~     early recognition of hypertrophic scars and keloids are very important in their management.~      Among preventive treatments available, silicone gel and onion extract gel have been marketed~     as products to improve the appearance and texture of surgical scars. Despite its popularity,~     data demonstrating the efficacy of these gels are lacking. Furthermore, there is no~     comparative study of silicone gel and onion extract gel for preventing postsurgical~     hypertrophic or keloid scars. The investigators therefore conducted this randomized~     controlled trial to compare the efficacy of silicone gel and onion extract gel for the~     prevention of postsurgical hypertrophic scars. The investigators also compared patient~     compliance and side effect between two topical gels.~   "
130356|NCT01861106|"~     Background:~      - GATA2 deficiency is a disease caused by mutations in the GATA2 gene. It can cause different~     types of leukemia and other diseases. Researchers want to see if a stem cell transplant can~     be used to treat this condition. A stem cell transplant will give stem cells from a matching~     donor (related or unrelated) to a recipient. It will allow the donor stem cells to produce~     healthy bone marrow and blood cells that will attack the recipient s cancer cells.~      Objectives:~      - To see if stem cell transplants are successful at treating GATA2 mutations and related~     conditions.~      Eligibility:~        -  Recipients who are between 8 and 70 years of age and have GATA2 deficiency, or the~          clinical syndrome MonoMac.~        -  Donors who are between 6 and 70 years of age and are matched with the recipients.~        -  Have a 10/10 or 9/10 HLA-matched related or unrelated donor, or a haploidentical related~          donor.~      Design:~        -  All participants will be screened with a physical exam and medical history. Blood~          samples will be collected. Recipients will have imaging studies and other tests.~        -  Donor participants will provide stem cells for the treatment. In some cases, Filgrastim~          injections will allow these cells to be collected from the blood. Bone marrow donations~          will be used as stem cells source.~        -  Recipients will have chemotherapy or radiation to prepare for the transplant. On the day~          of the transplant, they will receive the donated stem cells.~        -  Recipients will stay in the hospital until their condition is stable after transplant.~        -  Frequent blood tests and scans will be required for the first 6 months after the~          transplant, followed by less frequent visits over time.~   "
130357|NCT01861093|"~     Background:~      - Cord blood is blood that is taken from the umbilical cord and placenta of healthy newborns~     after childbirth. The cord blood collected from a baby is called a cord blood unit. Cord~     blood units are stored frozen in public cord blood banks. About 10,000 cord blood transplants~     have been performed in children and adults for blood cancers and other diseases in the world.~     These transplants have helped save lives and improve treatments. However, not all available~     units of cord blood have been collected, stored, and licensed according to specific~     government requirements. These unlicensed units can still be used in transplant, but they can~     only be given as part of specific research studies. This study will evaluate the safety of~     giving these unlicensed units by recording any problems that may occur during and after~     giving the cord blood.~      Objectives:~      - To test the safety and effectiveness of unlicensed cord blood units in people who need stem~     cell transplants.~      Eligibility:~      - Individuals who are scheduled to have a stem cell transplant.~      Design:~        -  Participants will be screened with a medical history and physical exam.~        -  Participants will receive the cord blood unit as part of their stem cell transplant~          procedure. The transplant will be performed according to the current standard of care~          for the procedure.~        -  After the transplant, participants will be monitored for up to 1 year. Any problems or~          side effects from the transplant will be treated as necessary. All outcomes will be~          reported to the National Cord Blood Program and to the Center for International Blood~          and Marrow Transplant.~   "
130358|NCT01861080|"~     The objective of this study is to know prevalence of clinical or subclinical target organ~     damages in Korea hypertensives by constructing nationwide hypertension registry. We will~     register 5000 consecutive patients with incident hypertension at 20 major university~     hospitals in South Korea. We will investigate clinical/subclinical target organ damages,~     renin/aldosterone level and cardiovascular events in each patient.~   "
130359|NCT01861067|"~     During the last 2 decades, several studies have tried to define the best surgical approach to~     hysterectomy for benign uterine diseases1. Accumulating evidence demonstrates that abdominal~     hysterectomy has a higher incidence of complications, a longer hospital stay and a slower~     convalescence in comparison with laparoscopic hysterectomy (LH). The main advantage of LHs is~     the absence of a wide abdominal scar, which results in fewer wound-related complications and~     in a significant decrease of postoperative pain.~      Technologic advances in endoscopic instrumentation and optics have allowed the development of~     an even less invasive procedure than conventional LH using multiple ports: laparoendoscopic~     single-site (LESS) surgery, also known as single-port access (SPA) laparoscopy3. In the LESS~     approaches, total laparoscopic hysterectomy (TLH) and laparoscopically-assisted vaginal~     hysterectomy (LAVH) are all feasible, with comparable conventional LH. However, it is yet to~     be determined which of two alternative and less invasive approaches (LESS-TLH and LESS-LAVH)~     should be preferred. In particular, none has focused on postoperative pain as the primary~     outcome of the study. The investigators have therefore designed the randomized trial to~     investigate specifically differences in postoperative pain after LESS-TLH and LESS-LAVH.~   "
130360|NCT01861054|"~     This is a pilot window of opportunity clinical study in patients with operable breast~     cancer investigating use of reparixin as single agent in the time period between clinical~     diagnosis and surgery. This study evaluates the effects of orally administered reparixin on~     CSCs in the primary tumor and the tumoral microenvironment in an early breast cancer~     population. The aim is to investigate if cancer stem cells (CSCs) and pathway markers~     decrease in two early breast cancer subgroups (ER+ and/or progesterone receptor~     positive/HER-2- and ER negative/progesterone receptor negative/HER‑2-) and to compare any~     differences between the two subgroups to try to better identify a target population. 20~     patients will be enrolled to each subgroup at ten sites in the US.~   "
130361|NCT01861041|"~     Spinal anesthesia, is used during the transuretheral resection of the prostate.Low dose~     hyperbaric local anesthetics have been used to enhance the resolution of the spinal block. We~     compared the efficacy and duration of the spinal block with two different bupivacaine~     baricities.~        -  Group I: low dose isobaric group~        -  GroupII: Low dose hyperbaric group~   "
130362|NCT01861028|"~     This study compares intraoperative fit of the patient-specific iTotal knee replacement to~     other standard knee replacement implants~   "
130400|NCT01860534|"~     Pupillary dilation induced by mydriatic agents during Retinopathy of Prematurity exams can~     persist for hours. Despite regular use of eye protection for mydriatic-induced light~     sensitivity for infants, children and adults, eye protection after mydriasis has not been~     addressed in neonates. This study examines the use of eye patches to protect the dilated~     pupil from light exposure and their impact on vital signs and pain scores. prevents~     tachycardia, tachypnea and discomfort in neonates after ROP screening.~   "
130363|NCT01861015|"~     Uterine myomas (fibroids or leiomyomas) are the most common benign tumor of the female~     genital tract and the leading indication for hysterectomy. Although hysterectomy is the~     definitive treatment of myomas, myomectomy remains the gold standard treatment for women~     desiring future fertility and uterine conservation3. However, bleeding is often a problem in~     myomectomy and can results in intraoperative hypovolemic shock, postoperative anemia, pelvic~     infection, and adhesions with infertility.~      A number of interventions have been introduced to reduce hemorrhage during myomectomy. Two~     categories of interventions can be identified: (a) Vascular interventions on uterine and/or~     ovarian arteries such as artery clamping, tying, or embolization; (b) pharmacologic~     interventions such as vasopressin, epinephrine, oxytocin, ergometrine, misoprostol,~     sulprostone, and gonadotropin-releasing hormone (GnRH) agonist4-11. Of these, intraoperative~     local injection of vasopressin causing vasospasm is most commonly used. However, there is not~     a wide consensus on the use of this agent because of serious side effects reported in~     literature. In addition, in several countries, including France and Italy, vasopressin has~     not been commercialized because of its potential adverse effects on cardiovascular system.~      Epinephrine also induces a vasoconstrictive effect on tissue that lasts longer than that of~     vasopressin (5-6 hours versus 7-35 minutes) and is used during various gynecological~     surgeries, endoscopic resection, and dermatologic procedures to reduce blood loss. However,~     there are a few studies for the use of epinephrine to reduce hemorrhage during myomectomy.~     Furthermore, a randomized comparison of epinephrine and vasopressin as hemostatic agents~     during myomectomy has never been conducted. To test the hypothesis that the injections of~     epinephrine and vasopressin during myomectomy are equivalent in reducing blood loss, the~     investigators performed this randomized controlled study.~   "
130364|NCT01861002|"~     This is a Phase I study with a conditional cohort expansion phase to evaluate the feasibility~     of, and to obtain preliminary efficacy data about, pretreatment with Azacytidine (AZA) for 5~     days followed by fludarabine/cytarabine chemotherapy regimen in pediatric acute myeloid~     leukemia (AML) and acute lymphoblastic leukemia (ALL) patients who are refractory to primary~     treatment or who relapsed.~   "
130365|NCT01860989|"~     This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria~     patients with acute P. falciparum infection after single dose with KAE609 at 75 mg, 150mg,~     225mg and 300mg/day~   "
130366|NCT01860976|"~     The purpose of this study is to compare subcutaneous Abatacept to placebo in the treatment of~     psoriatic arthritis~   "
130367|NCT01860963|"~     This study is designed to establish the prevalence of anal squamous intraepithelial lesion~     (ASIL) in patients with inflammatory bowel disease (IBD) and healthy controls.~   "
130368|NCT01860950|"~     The purpose of this study is to determine whether a new medical technology can temporarily~     alter pain perception. The new technology is called Transcranial direct current stimulation~     (tDCS).~   "
130369|NCT01860937|"~     The purpose of this study is to test the safety of giving the patient special cells made from~     their own blood called Modified T-cells. The goal is to find a safe dose of modified~     T-cells for patients whose leukemia has returned to the bone marrow.~   "
130370|NCT01860924|"~     In this project the investigators will develop and pilot test a supervised, vigorous~     intensity exercise intervention for depressed female smokers. If the pilot intervention is~     successful the investigators will have a blueprint for a large randomized controlled trial.~     The long term objective is to develop interventions for depressed women that will ultimately~     reduce their risk of tobacco-caused disease and mortality.~   "
130371|NCT01860911|"~     Increased accumulation of fat into the muscles is associated with what is called~     insulin-resistant state, which is a pre-diabetic state. The purpose of this research is to~     find out how fat circulating in the blood following fat consumption is taken up by the~     muscles in healthy people as well as people that are insulin-resistant. The investigators are~     specifically interested in how a hormone called insulin is involved in this process. Findings~     from this research will contribute to our understanding of why insulin-resistant people have~     increased accumulation of fat in their muscles, and ultimately help to design appropriate~     interventions to prevent type 2 Diabetes.~   "
130372|NCT01860898|"~     As part of the long-term goal of successfully implementing tissue regeneration strategies in~     an individualized manner for patients with thoracic diseases including, but not limited to:~     cystic fibrosis, pulmonary fibrosis and pulmonary hypertension, the investigators will assess~     the feasibility of collecting skin biopsies from patients undergoing surgery for thoracic~     disease, culturing skin fibroblasts from the biopsy, and reprogramming these skin fibroblasts~     into induced pluripotent cells.~   "
130373|NCT01860885|"~     Opioids are the mainstay of analgesia in hospitalized children but opioid therapy is~     associated with life-threatening respiratory depression requiring antagonism with naloxone.~     Hence, it is hypothesized that naloxone requirement can be used as a quality measure of~     opioid safety. A retrospective medical chart review of 95 patients, who received naloxone for~     life threatening events, from June 2006-2012, is planned, to identify significant factors~     associated with risk for opioid induced respiratory depression and formulation of preventive~     strategies.~   "
130374|NCT01860872|"~     The purpose of this research is to learn more about the heart and blood vessels in the lungs~     of people with cystic fibrosis (CF). This study will include approximately 36 children and~     adults with CF and 12 children and adults without CF. The study will involve one magnetic~     resonance imaging (MRI) . The research also includes blood samples to look at inflammation~     and lung tests called spirometry and Lung Clearance Index (LCI) determined by Multiple Breath~     Washout test.~      For the CF subjects, enrollment will be timed to coincide with routine scheduled computerized~     tomography (CT) or the CF subject may choose to have a CT for research purposes. The MRI will~     be compared to CT images of the lungs. The goal is to develop better imaging that does not~     use radiation.~   "
130375|NCT01860859|"~     This study compares three techniques of uterine closure on myometrium thickness evaluated by~     ultrasound six months after the primary cesarean. The three techniques include: 1) locked~     single layer closure; 2) double layer closure with a first continuous locked suture and a~     second imbricating continuous suture; 3) double layer closure with a first continuous~     unlocked suture of the deep portion of the myometrium avoiding the inclusion of the decidua~     and a second unlocked continuous suture that approximate the upper portion of the myometrium.~     The primary outcome is the mean myometrium thickness at the site of the uterine scar~     evaluated by transvaginal ultrasound at six months after cesarean.~   "
130376|NCT01860846|"~     This multicenter, prospective, post marketing observational study (PMOS) was designed to~     demonstrate long-term effects of anti-Tumor Necrosis Factor therapies on Work Productivity~     and Impairment scales in participants with moderate to severe Crohn's Disease (CD) under~     routine conditions. Secondary objectives of this study were long-term improvement of Quality~     of Life (QoL), evaluation of improvement of extraintestinal symptoms and comorbidities, and~     evaluation of safety.~   "
130377|NCT01860833|"~     Central mechanisms may play a role in pain perception during osteoarthritis (OA).Local~     inflammation (which involves production of pro-inflammatory cytokines such as interleukin~     (IL) 4 TNF-alpha, IL-6 and IL-8) is considered to be a major source of pain.~      Certain therapies that specifically interfere with the expression or actions of~     pro-inflammatory cytokines have been explored. NSAIDs have analgesic, antipyretic and~     anti-inflammatory properties and are extensively prescribed for several musculoskeletal~     disorders. Indeed, the Osteoarthritis Research Society International (OARSI) recently~     recommended the use of NSAIDs for management of knee and hip OA in symptomatic patients.~     These drugs have been shown to influence cytokine metabolism in the synovial fluid of OA~     patients with satisfactory relief of painful osteoarthritic joints.~      The aim of the current study was to explore whether NSAID treatment inhibits TNF-alpha, IL-6,~     IL-8, and VEGF secretion in the synovial fluid of osteoarthritic joints. In particular,~     diclofenac, ibuprofen and celecoxib were studied. Under the hypothesis that relationships~     between proinflammatory cytokines and the clinical status of OA patients are possible, we~     also evaluated the association between the concentration of these molecules in the~     osteoarthritic knee synovial fluid and the pain and functional status of patients with OA.~     The effects of NSAIDS on signal transduction pathways in the synovial membrane were also~     investigated.~   "
130378|NCT01860820|"~     This will be a randomized, controlled trial involving kidney and kidney pancreas transplant~     patients. There will be 2 groups and patients will be randomized to one of the two; one will~     receive standard of care IPC or TED stockings to help with circulation, the other group will~     use the geko device which is a newer device with Health Canada approval. Clinical outcomes~     will be compared for those in each group and clinical differences between patients who~     receive routine medical therapy with IPC/TEDS versus the Geko device will also be evaluated.~   "
130379|NCT01860807|"~     The objective of this study is to test the safety and potential efficacy of ibudilast to~     treat methamphetamine dependence. The study hypotheses are that ibudilast will reduce~     methamphetamine use and increase treatment retention more than placebo among patients seeking~     treatment for methamphetamine dependence. As HIV infection is a common complication of~     methamphetamine dependence, half of the participants will be HIV positive and the study will~     assess whether ibudilast also improves HIV related outcomes (e.g. medication adherence, CD4~     count, risk behaviors).~   "
130380|NCT01860794|"~     The purpose of clinical trials is to evaluate safety and tolerability of Fetal Mesencephalic~     Dopamine Neuronal Precursor Cells as a treatment for Patients with Parkinson's disease.~   "
130381|NCT01860781|"~     The purpose of this study is the evaluation of effectiveness of paliperidone palmitate within~     three different group of schizophrenia patients.~   "
130382|NCT01860768|"~     Acute aortic dissection (AAD) is an acute vascular lesions with high early misdiagnosis~     rate(31.8%), and mortality rate was 38%. In recent years, the incidence is rising and serious~     threat to human health. At present, the clinical diagnosis of AAD commonly used imaging~     methods, including chest X-ray, B ultrasound, CT, MRI and aortic angiography. Chest X-ray and~     two-dimensional ultrasound is limited in diagnosis of AAD, esophageal ultrasonography can~     display the intimal, identify the true and false lumen, but greater risk. CT, MRI and aortic~     angiography can be used as diagnosis method, but time-consuming, expensive and requires~     handling patients in emergency situations, should not be used as the preferred. Therefore, it~     is significance that biomarkers with high specificity and sensitivity for clinical fast~     diagnosis of AAD.~      Parts small sample tests found that single serum α-smooth muscle actin (α-SMA), myosin heavy~     chain(MHC) and human soluble elastin fragments (sELAF) levels in patients with AAD were~     significantly higher than that of others (normal people, acute myocardial infarction~     patients). But because of the small study sample, limited control risk factors and incomplete~     comparison, their conclusions were questionable. In our previous studies also found that~     serum α-SMA, MHC and sELAF levels and the pathogenesis of AAD and prognosis are closely~     related. Therefore, on the basis, a prospective study is needed. We observe all the three~     biomarkers in enrolled patients with acute chest pain in emergency department, levels in~     healthy volunteers as the blank control. Then make definite diagnosis of the enrolled~     patients, and further observe the biomarkers dynamic change in AAD. Lastly, evaluate the~     early diagnostic value of combination serum α-SMA, MHC and sELAF level on patients with AAD.~   "
130383|NCT01860755|"~     The purpose of this study is to determine the effects of a combined physiotherapy treatment~     (including vestibular rehabilitation and treatment for the cervical spine) in youth and young~     adults with ongoing symptoms of dizziness, neck pain and headaches following a sport-related~     concussion.~   "
130384|NCT01860742|"~     The purpose of this study is to assess the benefit of 177Lu-DOTATATE versus interferon α-2b~     in patients with progressive, unresectable, non-pancreatic gastrointestinal neuroendocrine~     tumors resistant to therapy with somatostatin analogues, in terms of disease control.~   "
130385|NCT01860729|"~     This study will evaluate the effects of anacetrapib on low-density lipoprotein-cholesterol~     (LDL-C) and high-density lipoprotein cholesterol (HDL-C) in participants with~     hypercholesterolemia when added to an existing statin therapy.~   "
130401|NCT01860521|"~     This study included women who underwent voluntary second trimester termination of pregnancy.~     Patients were randomized to programmed intermittent epidural anesthetic bolus or continuous~     epidural infusion for pain analgesia. In this randomized, double-blind study, the~     investigators assess the incidence of motor block (primary outcome), degree of satisfaction~     of the patients, total levobupivacaine and sufentanil consumption and adverse events~     (secondary outcomes) between the two study groups.~   "
130402|NCT01860508|"~     PFS~   "
130403|NCT01860495|"~     One of the most important elements suggested to be provided through membrane perforations to~     augment regeneration are cell released growth factors from the overlying periosteal and~     gingival cells. A direct correlation could exist between the number of such cells and their~     available released growth factors. To test this assumption, this study was designed to~     evaluate levels of bone morphogenetic protein-2 in gingival crevicular fluid (GCF) during the~     early stages of healing for sites treated by MPM compared to that of the occlusive barrier~     membranes.~   "
130404|NCT01860482|"~     The purpose of this study is to assess the efficacy and safety of Newrabell® Tab. in patients~     with refractory reflux esophagitis to the prior standard PPIs regimen.~   "
130386|NCT01860716|"~     Impact of melatonin on organ donor pretreatment and liver transplant recipient: prospective,~     randomized, double-blind trial.~      OBJECTIVES. To establish the efficacy of the melatonin administered to encephalic death~     donors (EDD) in liver transplantation. The aim is to improve the functional quality of the~     retrieved organs, attenuate lesions and ischemia-reperfusion mediators, and provide grafts~     with greater resistance to post-transplant aggression.~      METHODOLOGY. Prospective, randomized, double-blind, pilot trial to evaluate preconditioning~     with melatonin versus placebo in EDDs. Two groups, melatonin and control-placebo, n=30 per~     group. Administration to donor via NG tube of 30mg of melatonin or placebo (lactose) upon~     inclusion in the trial, 60 minutes prior to commencement of surgery and following laparotomy~     during extraction. Evaluation of response to treatment: A) Conventional clinical,~     hemodynamic, analytical and histopathological parameters in donor and recipient. B) Plasma~     determinations for: oxidative/nitrosative stress; acute phase proteins; cellular and humoral~     immunity; NT-proBNP and cystatin C; endocrine profile; melatonin levels. C) Determinations in~     liver tissue: quantification of malonyldialdehyde-4hydroxyalkenals and protein carbonyl~     content; cellular and mitochondrial membrane fluidity; markers of tissue-vascular damage and~     proliferation: transforming growth factor-beta (TGF-β); hypoxia-inducible factor (HIF) and~     vascular endothelial growth factor (VEGF). Data will be analyzed following a prospectively~     define plan and by intention-to-treat analysis.~   "
130387|NCT01860703|"~     Randomized, single-dose, double-blind, placebo and active controlled, four-period crossover~     study to evaluate the effect of deferiprone on QTc prolongation after administration of a~     single therapeutic (33 mg/kg) and supratherapeutic(50 mg/kg) oral doses of deferiprone in~     healthy volunteers as compared to placebo treatment.~   "
130388|NCT01860690|"~     The investigators want to compeer BHCG levels after Methotrexate ( MTX). treatment for~     Ectopic pregnancy in days 4 and 7 after MTX. to day 10 . The hypothesis is that BHCG level~     in day 10 is the best indicator for treatment success , superior to day 4 and 7 . According~     to the investigators impression BHCG level rises in days 4 and 7 due to destruction of the~     trophoblast tissue , and only day 10 is an indicator for treatment success~   "
130389|NCT01860677|"~     Document whether the Fischer Wallace Cranial Stimulator produces any measurable changes in~     brain activity.~   "
130390|NCT01860664|"~     The purpose of this study is to determine the safety and effectiveness of hydrocortisone~     ophthalmic ointment compared to placebo in the treatment of Allergic Conjunctivitis.~   "
130391|NCT01860651|"~     The investigators hypothesize that E-health - web based monitoring of disease and treatment -~     in young patients with chronic inflammatory disease (IBD) can improve the disease course and~     quality of life.~      Adherence (to take the prescribed medicine) is difficult for young patients. In this E-health~     project the investigators seek to improve young patients (10-17 years) responsibility for~     treatment, to empower them and thereby enhance the adherence in order to achieve a more quiet~     disease course. Through the e-Health program and web-app the disease activity will be~     presented to the young patient via a simple traffic light chart and the patient will be~     guided to: continue the prescribed medication, call the physician or visit the out-patient~     clinic. In future the concept is believed also to be applicable for young patients with other~     chronic diseases.~   "
130392|NCT01860638|"~     This multicenter, double-blind, placebo-controlled, randomized study will evaluate the~     efficacy and safety of the addition of bevacizumab treatment to lomustine (in 2nd-line [2L]~     treatment) and SOC (in 3rd-line [3L] and subsequent lines of treatment) following first-line~     disease progression (PD1) in participants with newly diagnosed glioblastoma. All enrolled~     participants will receive 1L treatment with radiotherapy, temozolomide, and bevacizumab. At~     PD1, eligible participants will be randomized (1:1) to receive 2L treatment with either~     bevacizumab plus lomustine or placebo plus lomustine. After second-line disease progression~     (PD2), participants will receive 3L treatment and will continue blinded bevacizumab or~     placebo with the addition of an SOC agent. Following third-line disease progression (PD3),~     participants will receive subsequent lines of treatment and will either continue blinded~     bevacizumab or placebo (at the discretion of the investigator), or switch to open-label~     bevacizumab (at the choice of the participant).~   "
130393|NCT01860625|"~     Study of the Safety, tolerability and pharmacokinetics with single dose of donepezil patch in~     healthy male subjects.~   "
130394|NCT01860612|"~     The purpose of this study is to evaluate the safety and effectiveness of an artificial iris~     prosthesis for the treatment of iris defects.~   "
130395|NCT01860599|"~     It is well known that diabetes and excessive or high blood sugars causes blood vessel and~     blood cell damage. It is also possible, then, that people with pre-diabetes may also start to~     have blood vessel and blood cell damage as the blood sugars rise from the normal range into~     the diabetic range. In addition to looking at potential damage, the question is whether or~     not this damage improves with exercise. This study aims to look at blood vessel and blood~     cells in three different ways by 1) looking at how the blood vessel responds to sheer force~     (a blood pressure cuff pumped up and then released after a few minutes). This is done by~     ultrasound. 2) By looking at blood tests such as blood sugar, cholesterol, and inflammation~     and 3) By looking at certain blood cells in the lab, how long they live and the number of~     cells left after a certain number of days, and again, if this improves with exercise.~   "
130396|NCT01860586|"~     The purpose of this study is to examine the effects of a drug called bevacizumab (Avastin) on~     the rates of recurrent retinal detachment and scar tissue formation.~   "
130397|NCT01860573|"~     The purpose of this study is to determine whether providing increased protein to premature~     infants in the first week of life allows for better growth during the hospital stay and~     improved developmental outcomes by age 2.~   "
130398|NCT01860560|"~     Order randomized crossover non-inferiority study evaluating the acute efficacy of High Flow~     Therapy (HFT) as compared to nasal Continuous Positive Airway Pressure therapy (CPAP) in the~     management of apnea / hypopnea index (AHI).~   "
130399|NCT01860547|"~     The study hypothesis is that the bioactive compounds of sea buckthorn berries (Hippophaë~     rhamnoides), their fractions, and bilberries (Vaccinium myrtillus). have positive effects on~     lipid and carbohydrate metabolism and will thus reduce the risk of developing metabolic~     diseases.~   "
130405|NCT01860469|"~     Soaking meshes in a vancomycin solution just prior to their use in open hernia repairs will~     decrease rates of mesh infection~   "
130406|NCT01860456|"~     Rationale~      The pharmacokinetics of imatinib and nilotinib, two BCR/Abl tyrosine-kinase inhibitors (TKI),~     is variable among patients suffering from chronic myeloid leukemia (CML). Transmembrane~     transporters may play a pivotal role in interindividual variability in TKI disposition.~     Furthermore, minimum plasma concentrations (Cmin) higher than 1 mg/L could be associated with~     a higher likelihood of molecular and cytogenetic responses.~      Therefore, the TIKlet study is aimed at evaluating any possible correlation among the~     pharmacogenetics of transmembrane transporters, imatinib and nilotinib pharmacokinetics and~     treatment efficacy/tolerability in CML patients.~      1. PATIENTS AND METHODS~      1.1. Patients~      Patients affected by CML will be enrolled in the TIKLet study after the informed consent will~     be signed. The following inclusion criteria will be adopted:~        -  patients of both sexes,~        -  age between 18 and 80 years,~        -  treated with imatinib or nilotinib,~        -  included in the follow-up in the Divisions / Units of Hematology involved in the~          project,~        -  able to give informed consent to trial participation,~        -  with a proved compliance with the scheduled treatment.~      The administration of other drugs will be allowed, but active pharmacological agents, their~     dose and duration of treatment should be known.~      Smoking and herbal products will be allowed but they should be recorded. Alterations in liver~     and kidney functions, body mass index >28, or any other alteration in physicochemical exams~     does not represent exclusion criteria.~      1.2. Enrolment and follow-up visits~      During enrolment visit, the following activities will take place:~        -  patients will be informed about the characteristics, objectives, and procedures of the~          study.~        -  Patient's consent to study participation will be confirmed by signing the informed~          consent form.~        -  Assignment of personal alphanumeric code.~        -  Collection of main data of the patient within the individual case report form (CRF).~        -  Collection of a blood sample (approximately 4 mL). At follow-up visits, a blood sample~          (approximately 4 mL) will be collected for therapeutic drug monitoring of drugs and~          patients' CRF will be updated. The blood sample and all of the records will be sent to~          the Dept. of Clinical and Experimental Medicine, University of Pisa.~      1.3. Blood samples~      Each tube containing the patient's whole blood, plasma or DNA and used for the execution of~     therapeutic monitoring or pharmacogenetic analyses will be identified by a) the patient's~     code and b) the date of execution of blood withdrawal.~      After centrifugation of the blood sample, the resulting plasma (1.5 mL) will be collected and~     stored in an eppendorf tube for the measurement of drug concentrations. During the enrolment~     visit, an aliquot of whole blood (0.5 mL) will be collected in a sterile eppendorf tube for~     molecular analyses. Both samples will be stored at -20 °C for a maximum of 2 weeks, then they~     will be sent to the Dept. of Clinical and Experimental Medicine, University of Pisa.~      1.4 Laboratory analyses~      The following analyses will be conducted at the Department of Clinical and Experimental~     Medicine, University of Pisa and at the Department of Pharmacology, University of Bologna.~      Plasma concentrations of drugs (i.e., imatinib and its metabolite, nilotinib) will be~     measured by high-performance liquid chromatography systems. Values of plasma concentrations~     will be analyzed by a population pharmacokinetic analysis to obtain main pharmacokinetic~     parameters (i.e., clearance of the drugs). Those parameters will help to describe in a~     quantitative manner drug disposition into every patient.~      Furthermore, DNA will be extracted from whole blood and genetic variants (called single~     nucleotide polymorphisms) will be investigated in the following genes that code for~     transmembrane transporters: ABCB1, ABCG2, hOCT1, OCTN1, OATP1A2.~      Finally, response to drugs, in terms of Major Molecular Response (MMR) and Complete~     Cytogenetic Response (CCyR), and tolerability will be evaluated. Any possible correlation~     among drug disposition, pharmacogenetics and treatment effects will be analyzed.~   "
130407|NCT01860443|"~     Background: Depression is common in adolescents and it is associated with serious~     consequences. In Chile, primary care team has a leading role in the management of depression~     in adolescents. Nevertheless, the majority of primary care professionals report not feeling~     adequately prepared to take on this responsibility and having difficulties referring patients~     to specialists. This situation is particularity complex in regions far away from the central~     zone. Telepsychiatry is a potential solution to an equitable access to specialized clinical~     expertise.~      Purpose: The purpose of this study is to determine whether a telepsychiatry-based~     collaborative program is effective to improve the management of depression in adolescents~     between 13 and 19 years of age in 16 primary care clinics in the Araucanía Region, Chile.~      Study design: A cluster-randomized clinical trial will be carried out with 237 adolescents.~     The efficacy, adherence, and acceptability of the telepsychiatry-based collaborative program~     will be evaluated.~   "
130408|NCT01860430|"~     This clinical trial is aimed to establish a recommended starting dose of ipilimumab for a~     future efficacy trial when used in combination with intensity modulated radiation therapy~     (IMRT) and cetuximab.~   "
130409|NCT01860417|"~     In this study we want to evaluate the clinical use of allogenic mesenchymal stem cells (MSC),~     obtained from bone marrow of healthy donors, for treatment of Degenerative Disc Disease~     (DDD). The trial is based in previous results with autologous MSC (Orozco et al.,~     Transplantation 92: 822-828; 2011). Here we propose a phase I-II trial, prospective,~     randomized, blinded, and controlled for the treatment DDD using MSV, a Good Manufacturing~     Practice (GMP)-compliant expanded bone marrow MSC (MSV, PEI Num. 10-134). The assay consists~     of two arms with 12 patients each one. Patients in the experimental arm will be given a~     single intra-discal transplantation of MSV (25 millions in 2 ml). Control patients will be~     infiltrated in the paravertebral muscles close to the lesion with 2 ml of 1% mepivacain. We~     shall follow the evolution of pain, disability and quality of life as well as disc fluid~     content by Magnetic Resonance Imaging (T2-calibrated).~   "
130410|NCT01860404|"~     This study is a randomized, placebo-controlled, double-blinded, therapeutic exploratory~     clinical trial of branched chain amino acids (BCAA's) in the treatment of concussion. The aim~     of the study is to determine whether, compared to placebo treatment, administration of~     BCAA's, at one or more doses, after a concussion improves neurocognitive recovery at one or~     more time-periods post concussion.~   "
130411|NCT01860391|"~     The aim of the study is to measure salivary fluoride and silver levels up to 7 days~     post-treatment.~      The participants will be 6 healthy adults. They will be given a fluoride free toothpaste to~     use the day before the study and all during the study.~      3 participants will have 6 teeth treated (Group A).3 participants will have 28 teeth treated~     each on the facial aspect (Group B).~      On day 0, the participant will be given 25 ml of de-ionized fluoride free water to swish in~     the mouth and spit the entire contents into a 50 ml collection tube. This will be done 3~     times.~      On day 0, 10 minutes after the rinsing and spitting, the participant will provide a~     unstimulated salivary sample into a universal collection tube until 5 ml are collected. The~     tubes with saliva will be stored on ice and then frozen at -20oC for transfer to the lab at~     the University of Washington.~      On Day 0, Isolation and application of silver fluoride.~      The quadrant will be isolated with cotton rolls, and surrounding gingiva will be covered with~     petroleum jelly to provide additional protection.~      After application, participant will be given 25 ml of fluoride free water to rinse as in 1~     above and water collected. This will be done 10 times.~      DAY 1-6 Salivary Collection~      Measures: Fluoride will be measured using standard fluoride electrode analysis (Martinez-Mier~     et al., 2011). Silver will be measured using Inductively Coupled Plasma-Mass Spectrometry~     (EPA 6020a Rev.1 2007) at the University of Washington~   "
130412|NCT01860378|"~     This study is a small-scale randomized, placebo-controlled factorial trial of two~     interventions to increase Tetanus, diphtheria and acellular pertussis (Tdap) immunization~     rates among infant caregivers. Specifically, the trial will compare a full cost vs. $5 Tdap~     voucher with or without an educational video.~   "
130413|NCT01860365|"~     In 2007, the Haifa and Western Galilee district of the CHS set out to test the feasibility of~     integrating complementary medicine (CM) within the CHS Oncology Service. In 2008, the CHS~     established the Integrative Oncology Program with the goal of addressing patient concerns and~     improving quality of life parameters during chemotherapy and advanced disease. The study~     hypothesis is that integrated medicine consultation and treatment provided within the~     oncology department may improve patients' concerns and well-being.~   "
130414|NCT01860352|"~     The purpose of this study is to see what effects the dietary supplement called Omega-3 or~     Fish Oil and it has on your colon, if any. Omega-3 (Fish Oil) is available in many forms~     (pills, capsules, liquid) in grocery stores, health food/vitamin stores and drug stores and~     from eating fish. We would like to learn if different amounts of Fish Oil specifically chosen~     for you individually change your colon tissue (large intestine). We hope that Fish Oil may be~     useful in the future as something that may help to prevent colon cancer, but we don't have~     any research in humans that shows that yet. We have to do this study first to see if Fish Oil~     effects the colon. One type of Fish Oil is has been approved by the U.S. Food and Drug~     Administration (FDA) to reduce the risk of heart disease. We are going to test a different~     Fish Oil supplement made by a company called Nordic Naturals.~      The colon lining or mucosa comes in contact with all the undigested things we eat or drink~     as it passes out to waste (stool). Animal studies suggest that fish oil may help the colon~     lining by reducing colon polyps and therefore colon cancer. We think this happens through~     chemical changes in the colon lining and also in the blood. The chemicals that we are looking~     at are called fatty acids. We want to see if taking different amounts fish oil chosen for~     you changes these chemicals (fatty acids) in your colon or your blood. We will assign you a~     personal low dose of fish oil to take for 2 weeks, followed by a high dose, or maximum~     dose for 2 weeks. We will calculate your basal Metabolic Rate (BMR) from your height, weight,~     age and assess your activity factor. We have a table that then tells us your target low and~     high dose. Then, based on your blood samples, we figure out which target dose is the one for~     you that will change these chemicals (fatty acids) by about ½ (50%). We will check how well~     this process worked by collecting small pieces of colon tissue (biopsies) of the colon before~     any fish oil and after all the fish oil is consumed. We will also use blood samples to test~     for these fatty acids and a few others. We are going to collect diet information at several~     times throughout the study so we can see if the food you eat makes a difference too.~      We hope to learn a lot about how fatty acids are metabolized (broken down or used) in the~     colon directly in combination with Omega-3 supplements.~   "
130464|NCT01859689|"~     This phase II trial studies how well internal radiation therapy works in treating patients~     with low-risk prostate cancer. Internal radiation uses radioactive material placed directly~     into or near a tumor to kill tumor cells.~   "
130465|NCT01859663|"~     The purpose of the study is to identify lifestyle factors associated with PCOS and understand~     how diet and activity levels impact features of PCOS. The secondary aim is to examine~     psychosocial factors (e.g., health beliefs) of women with PCOS.~   "
130415|NCT01860339|"~     Huntington's Disease (HD) is an autosomal dominant disease manifested in a triad of~     cognitive, psychiatric, and motor signs and symptoms. HD is caused by a triplet repeat~     (CAG)expansion in the gene Huntingtin (HTT). This disease has classically been conceptualized~     as a neurodegenerative disease. However, recent evidence suggests that abnormal brain~     development may play an important role in the etiology of HD. Huntingtin (HTT)is expressed~     during development and through life. In animal studies, the HTT gene has been shown to be~     vital for brain development. This suggests that a mutant form of HTT (gene-expanded or CAG~     repeats of 40 and above) would affect normal brain development. In addition, studies in~     adults who are gene-expanded for HD, but have not yet manifested the illness, (pre-HD~     subjects) have significant changes in the structure of their brain, even up to 20 years~     before onset of clinical diagnosis. How far back these changes are evident is unknown. One~     possibility is that these brain changes are present throughout life, due to changes in brain~     development,though initially associated with only subtle functional abnormalities.~      In an effort to better understand the developmental aspects of this brain disease, the~     current study proposes to evaluate brain structure and function in children, adolescents, and~     young adults (ages 6-18) who are at risk for developing HD - those who have a parent or~     grandparent with HD. Brain structure will be evaluating using Magnetic Resonance Imaging~     (MRI) with quantitative measures of the entire brain, cerebral cortex, as well as white~     matter integrity via Diffusion Tensor Imaging. Brain function will be assessed by cognitive~     tests, physical and neurologic evaluation, behavioral assessment, and quantitative~     craniofacial structure assessment. Subjects that are gene-expanded (GE) will be compared to~     subjects who are gene non-expanded (GNE) and as well to matched healthy controls. Changes in~     brain structure and/or function in the GE group, compared to both GNE and control groups,~     would lend support to the notion that this disease has an important developmental component.~   "
130416|NCT01860326|"~     This is an open-label study to evaluate the pharmacokinetics, safety and tolerability of~     single oral doses of Alisporivir in subjects with mild and moderate hepatic impairment~     compared to matched healthy subjects with normal liver function.~   "
130417|NCT01860313|"~     The purpose of this study is to create a web-based interactive educational environment to~     train elementary teachers, to identify children and adolescents in need of specialized mental~     health care and give them some advises in managing problematic children in class. After the~     creation of such an educational environment the psychoeducational project was tested in order~     to verify it's effectiveness.~   "
130418|NCT01860300|"~     This study is an extension of the European Multicentre Tics In Children Studies (EMTICS)~     COURSE study for which a separate study protocol exists; Aim of this clinical trial is to~     study the efficacy of treatment with antibiotics in reducing severity of tics and associated~     neuropsychiatric symptoms in patients with a tic disorder colonised by GAS.~      Primary Objective: Test the hypothesis that antibiotic treatment of GAS colonisation compared~     to placebo is associated with a larger reduction of tic and associated neuropsychiatric~     symptoms in the short-term (1 month) in patients with a tic disorder colonised by GAS.~      Secondary Objective: Test the hypothesis that antibiotic treatment of GAS colonisation is~     superior to placebo in the long-term (1 year) reduction of tic and associated~     neuropsychiatric symptoms in patients with a tic disorder colonized by GAS.~      Patients affected by a chronic tic disorder followed in the EMTICS- Longitudinal Course Study~     that show a positive culture for GAS at any microbiological examination during their~     follow-up will be considered eligible for the treatment trial.~      Patients showing GAS positivity will be invited to participate in the clinical trial.~      The patients enrolled will be randomly assigned to antibiotic or placebo in a 1:1 ratio.~      All participating patients will undergo a microbiological, serological and clinical~     assessment 1 month after the date of entering in the treatment trial (i.e. around 20 days~     after the end of treatment). Then, the patients will be followed with clinical, laboratory~     and microbiological assessments every four months for 1 year.~      Patients will be deblinded at the end of the treatment trial follow-up (1 year after the~     recruitment).~      Patients who will develop a true GAS infection or who otherwise need to be prescribed~     antibiotics for any clinical reason during the follow-up will be withdrawn from the study and~     immediately deblinded. Data of such patients would, however, remain part of the study~     analyses, following the intention-to-treat principle.~   "
130419|NCT01860287|"~     In this study, the investigators will examine the effects of buprenorphine, as compared to~     placebo, upon physiological, subjective, and hormonal responses to a stressful speech task~     and a non-stressful control task in healthy adults. There is strong evidence in support of~     the role of endogenous opioids and opiates in mediating social behavior in humans and other~     animals, and particularly, in social distress. Recently it has been shown that buprenorphine,~     a partial mu-opioid agonist, reduces sensitivity to recognition of fearful facial expressions~     in humans. Here, the investigators propose to further explore the role of the opioid system~     in mediating stress responses in humans through the use of buprenorphine. The investigators~     hypothesize that buprenorphine with reduce both physiological and subjective measures of~     stress.~   "
130420|NCT01860274|"~     The study hypothesis is that a meshed conduit made of safen vein allows a better patency at~     mid-long term than a safen vein alone.~      To test this hypothesis the investigators plan a prospective, randomized study, comparing~     grafts to the diagonal, in cases of vessel diameter under 1.5mm. A control angiography will~     be performed one year after the operation.~   "
130421|NCT01860261|"~     This pilot study will test the feasibility and acceptability of a 12 week combined aerobic~     and strength training intervention among persons with HIV who are age 50 or older and do not~     exercise frequently, and its preliminary effects on aging-related outcomes . The study uses~     an randomized, controlled trial design and is intended to lead to a larger clinical trial~     with long-term follow-up. The intervention incorporates small group instruction from a~     trainer, a small wearable accelerometer to provide accurate data on physical activity, and~     real-time feedback to participants about exercise levels. The primary outcome measure will be~     changes in fitness, measured as change in maximal oxygen consumption (VO2 max). The control~     group will receive a comparable exercise intervention after they complete 12 weeks of~     observation.~   "
130422|NCT01860248|"~     This study was aimed to compare pain levels from arterial blood gas (ABG) sampling performed~     with vapocoolant spray in comparison to placebo.~   "
130423|NCT01860235|"~     Injectable anesthesics previous to subgingival scaling and root planing (SRP) presents some~     disadvantages like fear of the needle insertion, long-lasting effect and prolonged dampening~     of adjacent tissues. This study will compare the intrapocket anesthetic effectiveness of a~     skin topical anesthesic EMLA with intrapocket 2% benzocaine, intrapocket placebo and~     injectable anaesthesia for SRP in a Split-mouth, double-blind, clinical trial study.~   "
130424|NCT01860222|"~     The aim of this study is to compare the operative complication and short-/long-term~     therapeutic effects of percutaneous local ablative therapy (PLAT) versus surgical~     resection(SR) on small hepatocellular carcinoma(HCC) patients with clinically significant~     portal hypertension(CSPH) so as to lend clinical and theoretical basis of the therapeutic~     schemes for the disease.~   "
130425|NCT01860209|"~     The purpose of this study is to investigate the effect of decreasing fluid overload by~     hemodialysis on the severity of obstructive sleep apnea, in patients with end stage chronic~     kidney disease on intermittent hemodialysis. It aims further to investigate the relationship~     between overhydration, nocturnal rostral fluid shift and the severity of sleep apnea.~   "
130426|NCT01860196|"~     This study aimed to compare the efficacy and safety of Meditoxin® injection for cervical~     dystonia in adults with cerebral palsy. It is a placebo controlled, Cross-over, Double blind,~     Randomized, Clinical trial.~   "
130427|NCT01860183|"~     Development of chronic changes (scarring) in transplanted kidney tissue is a major cause of~     long-term kidney function deterioration and ultimately graft loss. It results from both~     immunologic and non-immunologic mechanisms. Mycophenolate mofetil (MMF) is immunosuppressive~     drug used for prevention of rejection after kidney transplant, usually in combination with a~     calcineurin inhibitor (tacrolimus or cyclosporine), with or without corticosteroids. Besides~     immunosuppression, MMF may also have direct antifibrotic properties. Tacrolimus has potent~     immunosuppressive effects and is the cornerstone of contemporary posttransplant~     immunosuppressive therapy in kidney recipients. However, it is also nephrotoxic. The~     hypothesis of the present study is that in the setting of similar net immunosuppression,~     higher dose of MMF (3 g daily) will result in slower progression of kidney fibrosis during~     first year posttransplant as compared to MMF 2 g daily. To test this hypothesis, the present~     study will randomly assign low immunological risk kidney transplant recipients to either 2g~     or 3 g MMF daily, in combination with tacrolimus, with, or without maintenance steroids. All~     patients will have kidney biopsy at implantation and at 12 months after transplantation. Main~     outcome will be 1-year change in chronic kidney histology (interstitial fibrosis) assessed by~     protocol biopsy.~   "
130428|NCT01860170|"~     The purpose of this study is to determine if Bortezomib, known commercially as Velcade is~     safe and tolerated at different dose levels (amounts) with high dose Cyclophosphamide to be~     used as graft versus host disease prevention after reduced-intensity allogeneic hematopoietic~     stem cell transplantation.~   "
130429|NCT01860157|"~     In this study, the investigators will be examining the effects of the deep repetitive~     transcranial magnetic stimulation (rTMS) using the H1 coil in patients over the age of 60 who~     have been unable to tolerate or failed to respond to antidepressant medications. The coil was~     designed to stimulate deeper regions of the left DLPFC. The investigators propose that active~     stimulation with the H1 coil will result in higher remission rates than placebo stimulation~     but will have a similar tolerability and safety profile.~   "
130430|NCT01860144|"~     This observational, multicenter, prospective study will evaluate the use of bevacizumab in~     real clinical practice in chinese patients with metastatic colorectal cancer.~   "
130431|NCT01860131|"~     Extreme obesity is present in 9% of the Canadian population. Extremely obese people have a~     high chance of developing health problems and dying early. Our national guidelines recommend~     that extremely obese individuals receive multidisciplinary treatment, meaning that a number~     of specialized care providers should be available to help administer obesity treatments to~     these patients.~      The investigators oversee a large obesity program called the Weight Wise Obesity Program,~     which delivers multidisciplinary care at 5 sites in Alberta, Canada (Edmonton, Calgary, Grand~     Prairie, Medicine Hat, Red Deer). Wait times to enter the Weight Wise clinics range from a~     few months to three years depending on the site in Alberta. The investigators performed a~     survey of the patients on the wait list in Edmonton and discovered that they self- report~     extremely poor health and feel that the long wait times are partly responsible for this poor~     health. To try to support these patients as they wait for multidisciplinary care, the~     investigators designed a group based self-management intervention, consisting of Weight Wise~     Community Modules. Patients attend this program over three months to receive weight~     management education (diet, exercise, stress management, coping strategies).A web-based~     version of the modules is also available.~      The investigators wish to determine if these modules delivered to patients prior to entering~     the clinic help to reduce weight, improve quality of life in the wait listed patients and~     also to see if going through the modules helps patients to be more ready for weight~     management when they reach the Weight Wise clinic. The investigators also wish to examine~     whether or not these modules are cost effective. If these modules are not useful, a more~     effective way to support wait listed patients will be sought.~   "
130432|NCT01860118|"~     This proposal seeks to 1) determine whether there are biomarkers associated with Parkinson's~     disease (PD) susceptibility and/or progression in exosome-proteomes derived from PD patients~     versus controls, and 2) to determine if LRRK2 expression and/or phosphorylation are~     significantly lowered in the exosomes of individuals treated with the potent LRRK2 kinase~     inhibitor sunitinib (a multi-kinase inhibitor compound), to establish an assay for on-target~     effects for future LRRK2 inhibitor clinical trials.~   "
130433|NCT01860105|"~     Following a first, dose ascending study that enrolled 144 normal healthy volunteers (NHVs),~     this study, to be conducted in approximately 36 NHVs, will provide pertinent information in~     determining the dose-response of MDCO-157 for platelet aggregation inhibition and P2Y12~     receptor inhibition effects and in selection of doses that match the antiplatelet effects of~     300 mg PLAVIX® ®. The study will also provide additional data for pharmacokinetics (PK),~     safety and tolerability of single doses of MDCO-157.~   "
130434|NCT01860092|"~     This post-approval study is being implemented to monitor the use of Argus II System in a~     larger US population than available within pre-approval studies. An attempt will be made to~     include all eligible and willing subjects implanted with Argus II System in the United~     States.~   "
130435|NCT01860079|"~     -  When Primary percutaneous coronary intervention (PPCI) is performed expeditiously and at~          a high-volume centre, it is the optimal approach for ST elevation myocardial infarction~          (STEMI) . In contrast to the clarity of how to treat STEMI, there is no clear definition~          for when to discharge and which patient to discharge.~        -  An early discharge strategy may be desired by all parties (financial health care~          provider, treating physician, nurse, patient, patient's relatives)involved in STEMI.~        -  The main goal in our study is to test the hypothesis that an early discharge strategy~          within 48-56 hours in patients with successful PPCI is as safe as in those patients who~          stay longer (96-120 hours) as of a standard procedure.~   "
130436|NCT01860066|"~     Study is to show that QVA149 is superior to the standard of care, fluticasone/salmeterol, in~     patients with moderate to severe airflow limitation.~   "
130437|NCT01860053|"~     The purpose of this study is to reduce problematic vomiting and associated gastrointestinal~     symptoms in post-operative LAGB patients. We hypothesize that our behavioral intervention~     will yield greater reductions in vomiting and associated symptoms compared to our control~     condition.~   "
130438|NCT01860040|"~     To determine the rate of pathologic complete responses (pCR) at the time of definitive~     surgical resection of non-small cell lung cancer (NSCLC)~   "
130439|NCT01860027|"~     The mechanism of the eye movement anomalies seen in dyslexic patients is not well defined.~     Some optometrists use observational eye movement tests as screening devices for dyslexia and~     advocate eye movement therapy as a treatment option for dyslexia. The reliability of the~     clinical eye movement tests and the efficacy of the eye movement therapies have not been~     determined.~      Saccades are the fast eye movements that move our eyes from one word to the next when we~     read. The eye movement recordings from patients diagnosed with reading disorders, extra~     ocular muscle imbalances and control patients (no learning disability or eye movement~     disorder) will be analyzed and compared. The sensitivity and specificity of detecting reading~     disorders will be determined for the Visagraph III and the Readalyzer. Although these~     clinical tests are frequently used to diagnose saccadic inaccuracies and diagnose dyslexia in~     school aged children, the validity of these clinical screening tests has not been determined.~   "
130440|NCT01860014|"~     The incidence of pulmonary hemorrhage (PH) was about 1.3 per 1,000 live births. PH occurs~     mainly in preterm ventilated infants with severe respiratory distress syndrome (RDS) who~     often have a PDA and have received surfactant. Although not clear, the cause of PH is thought~     to be due to a rapid lowering of intrapulmonary pressure, which facilitates left to right~     shunting across a patent ductus arteriosus and an increase in pulmonary blood flow.~     Prospective uncontrolled studies that used surfactant for PH in neonates have shown promising~     results in treating PH.In this study we aimed to evaluate the effect of two different natural~     surfactants in neonates with pulmonary hemorrhage.~   "
130441|NCT01860001|"~     The aim of this study is to define the incidence and nature of acidosis after major surgery~     using Figge's equations to directly measure acidosis. This study will also aim to compare the~     ability of indirect measures (base deficit, anion gap,corrected anion gap and lactate) to~     identify the presence of tissue acids in this population. The incidence of postoperative~     ketoacidosis as a contributor to tissue acidosis will be assessed through the use of point of~     care urinalysis.~   "
130442|NCT01859988|"~     To assess the efficacy of multiple dupilumab dose-regimens, compared to placebo, in adult~     participants with moderate-to-severe atopic dermatitis (AD).~   "
130443|NCT01859962|"~     This study is designed to provide a preliminary assessment of the safety and effectiveness of~     the combination of PPI-668, BI 207127 and faldaprevir, with or without ribavirin, in the~     treatment of chronic hepatitis C virus infection.~   "
130444|NCT01859949|"~     To assess the long-term safety of Genotropin(somatropin) on Small for Gestational Age (SGA)~     without epiphyseal closing.~   "
130445|NCT01859936|"~     The study is a prospective randomised multicenter trial assessing the additional value of~     breast MRI in women under 56 years of age with newly diagnosed breast cancer. Will~     preoperative breast MRI change treatment regimen? Will preoperative breast MRI reduce the~     number of primary surgeries? Will preoperative breast MRI increase the rate of mastectomies?~     Will preoperative breast MRI be cost effective?~   "
130446|NCT01859923|"~     The purpose of this trial is to assess the safety, tolerability, pharmacokinetics, and~     efficacy of long-term (6-month) treatment with delamanid plus an optimized background regimen~     of other anti-tuberculosis drugs in pediatric patients who completed Trial 242-12-232.~   "
130447|NCT01859910|"~     To investigate whether compression of the lid margin increase microbial contamination risk of~     patients undergoing cataract surgery~   "
130448|NCT01859897|"~     The objective of this five-year prospective observational follow-up study is to examine the~     additional benefits of using cardio-ankle vascular index (CAVI) as a predictive indicator of~     cardiovascular events in high-risk patients.~   "
130449|NCT01859884|"~     The objective of this study is to evaluate kidney transplant candidates' comprehension about~     increased risk donor kidneys necessary for informed consent. We have developed a web-based~     tool that educates and assesses candidates' comprehension (Inform Me), as a supplement to~     current informed consent processes. We will then compare the effectiveness of the current~     informed consent processes supplemented by Inform Me, with the current consent processes~     alone for kidney transplant.~   "
130450|NCT01859871|"~     The purpose of this study is to increase understanding about living kidney donation (LKD)~     among Hispanic/Latino patients and public by increasing knowledge and positive attitudes~     about LKD. Improving Hispanics' understanding about LKD will ensure that Hispanic patients~     and public are fully informed of the treatment options for End Stage Kidney Disease.~   "
130451|NCT01859858|"~     Curcumin is an extract of the tumeric root that has been shown to have anti-tumor properties~     in laboratory studies. Curcumin, and its parent spice, turmeric (curcuma longa), are the 4th~     most commonly purchased dietary supplement in the U.S. Many cancer patients take curcumin~     during their treatment for cancer because of the purported health benefits.~      This research study is designed to learn more about the safety, pharmacokinetics and~     effectiveness of irinotecan when given in combination with curcumin in patients with~     metastatic colorectal cancer. The study of how the body absorbs, processes and eliminates~     drugs is called pharmacokinetics (PK). One of the main purposes of this study is to better~     understand the interaction between curcumin and irinotecan by measuring levels of irinotecan~     in the blood (ie. measure irinotecan PK) when a patient also takes curcumin. Information~     collected from this study could result in improved dosing guidelines and lead to more~     effective treatment of your cancer with less toxicity.~   "
130452|NCT01859845|"~     The specific aim of this study is to determine if interactive touchscreen-based learning with~     deliberate practice modules can enhance the retention of life-saving medical skills when~     incorporated into medical training curricula. We will analyze the retention and confidence of~     screening skills by comparing outcomes on pretest and posttest in each arm.~   "
130477|NCT01859507|"~     During the first visit, the couple will be acquainted with their condition. This will include~     the epidemiology of their condition, some sex education tips, as well as the therapeutic~     modalities available. This is followed by short description of the protocol. In the procedure~     room, each patient will be examined to determine the degree of vaginismus and classify her~     condition according to Lemont's classification as modified by Pacik, from 1 to 5. In the same~     or subsequent sessions, surface anesthesia of the area of injection followed by ice packs is~     used before the BOTOX is injected into the muscle.~   "
130478|NCT01859494|"~     The purpose of this study was to determine if untrained subjects who have diabetes can~     operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose~     results.~   "
130453|NCT01859832|"~     Patients undergoing renal transplantation at London Health Sciences Centre, University~     Hospital and who are participating in the study A Comparison of Effects of Standard Dose vs~     Low Dose Advagraf with IL-2 Receptor Antibody Induction, MMF and Steroids, With or Without~     ACEi/ARB-based Antihypertensive Therapy on Renal Allograft Histology, Function, and Immune~     Response will be evaluated with the ImmuKnow Assay to assess the ability of this assay to~     predict underimmunosuppression (rejection) or overimmunosuppression determined by this test~     and to determine retrospectively whether decision making utilizing this novel assay would~     have improved outcomes over standard techniques.~      This study is designed to evaluate an in vitro assay (Cylex®ImmuKnow Assay) for the~     measurement of cell-mediated immune response in renal transplant patients receiving~     immunosuppressive therapy. This assay measures ATP as an activation response of CD4+ cells to~     stimulation with phytohemagglutinin (PHA) in whole blood samples as a reflection of the~     immune system of the patient at any point in therapy. The natural history of the immune~     status of the renal transplant recipient as reflected by the ImmuKnow assay will be~     determined at specific time points of interest including: pre and post transplant, as an~     adjunct to therapeutic drug monitoring, and pre and post infectious or rejection episode.~     Analysis of the results of the assay at these time points will allow us to retrospectively~     study the effects of routine immunosuppressive agent modulation on immune function, and its~     subsequent effects in times of renal allograft insult.~   "
130454|NCT01859819|"~     To safely reduce the burden of therapy in children, adolescents and young adults with mature~     B-NHL by reducing the number of intrathecal (IT) injections by the introduction of IT~     Liposomal Cytarabine (L-ARA-C, [Depocyt®]) and reducing the dose of anthracycline~     (doxorubicin) in good risk patients with the addition of rituximab to the FAB chemotherapy~     backbone (Immunochemotherapy).~   "
130455|NCT01859806|"~     Pancreaticoduodenectomy (PD)is the treatment of choice for patients with periampullary tumour~     (benign or malignant). In the recent years, the mortality rate of PD has decreased to 5% in~     many centers. However, pancreatic fistula (POPF) still occurs in 5 % to 40% of patients after~     PD. The hypothesis that isolated Roux loop PJ with isolated pancreatic drainage decrease the~     incidence of PF and severity with preservation of pancreatic function.~      So the investigators compare isolated Roux Loop Pancreaticojejunostomy (PJ) Versus~     Pancreaticogastrostomy (PG) as regards incidence of POPF, severity of POPF and functional~     outcome.~   "
130456|NCT01859793|"~     The study is being performed to determine whether sitagliptin, a dipeptidyl peptidase-4~     inhibitor, both acutely and chronically improves blood vessel function. Patients with type 2~     diabetes who are on metformin will be enrolled in this study for up to 22 weeks in this~     double blinded cross over study where they will receive a sitagliptin pill once a day for 8~     weeks and during a separate 8 weeks receive a matching placebo pill. The treatment periods~     are divided by a 4 week period. Blood vessel function will be measured by ultrasound before~     and after a single dose of sitagliptin and placebo, as well as after 8 weeks of treatment~     with each. Blood will also be taken to measure blood markers of inflammation at each time the~     ultrasounds are performed.~   "
130457|NCT01859780|"~     Unintentional poisonings of children continues to be a major issue in the US. According to a~     study conducted by Cincinnati Children's Hospital Medical Centers, during the period from~     2001-2008, emergency room visits for children less than 5 rose 28% as the result of~     pharmaceutical products. The authors note, the problem of pediatric medication poisoning is~     getting worse, not better.~      Child resistant closures have been required on most medications sold in the US since the~     early 1970s. However, most designs attempt to thwart children through purely physical means~     (e.g. simultaneous dissimilar motion or opening using sequential tasks). Few, if any designs,~     have utilized perception and cognition as a way to enhance child resistance.~      The investigators propose utilizing visual illusions in spaces distinct from the opening~     mechanism of prescription packages as a means of enhancing child resistance. In this project,~     visual illusion images are applied to both vials and wallet blisters in order to attract~     children's interest and prolong the time before opening.~      During Stage I, the investigators will determine if the visual distractor attracts attention~     when samples are displayed in a storage rack. During Stage II, the investigators will test~     the effect of visual distractors on child resistance as measured by successful openings and~     time to open.~   "
130458|NCT01859767|"~     This is a Phase 1, single center, open-label, non-randomized, clinical study in probable AD~     patients and HVs to evaluate the efficacy, safety and tolerability of a single dose of~     MNI-672. The underlying goal of this study is to assess MNI-672 SPECT imaging as a tool to~     detect ß amyloid deposition in the brain of AD research participants and young healthy male~     subjects. All study procedures will be conducted at Molecular NeuroImaging (MNI) in New~     Haven, CT. Approximately 3 patients with AD and 3 young male HVs will be recruited to~     participate in this study. HVs will be screened to ensure that there is no evidence of~     cognitive decline or significant neurological deficit.~      All eligible subjects will be required to visit the study center on at least 2 occasions:~        1. for one or more screening visits which should include a history and physical~          examination, laboratory and extensive neuro-psychological testing and MRI brain~          scanning. AD subjects will also undergo Amyvid PET imaging as part of the Screening~          Visit.~        2. on one day for baseline examinations and MNI-672 administration and subsequent SPECT~          scanning- followed by safety measures~   "
130459|NCT01859754|"~     Study Design:~      This is a 2 arm non-interventional trial that will compare the occurrence of adverse drug~     reactions between Octagam 5% and other marketed IVIG infusion treatments.~   "
130460|NCT01859741|"~     The study consists of a Phase1b lead-in portion to determine the MTD of OMP-59R5 in~     combination with EP for 6 cycles followed a Phase 2, multicenter, randomized,~     placebo-controlled portion comparing the efficacy and safety of OMP-59R5 in combination with~     EP for 6 cycles followed by single agent OMP-59R5 relative to EP alone for 6 cycles in~     subjects receiving first-line therapy for extensive stage small cell lung cancer.~   "
130461|NCT01859728|"~     To evaluate safety and efficacy of the combination cisplatin plus irinotecan in the treatment~     of biliary tract cancer.~   "
130462|NCT01859715|"~     This study examines how hepatic cytochrome CYP2D6 drug interactions affects the efficacy of~     oxycodone, hydrocodone, and ondansetron in Emergency Department (ED) patients.~   "
130463|NCT01859702|"~     The purpose of this study was to determine the moxifloxacin aqueous penetration when dosing~     with a combination drug Vigadexa preoperatively in cataract patients.~   "
130466|NCT01859650|"~     The University of Sheffield is one of the leading centres in the world for basic and~     translational research with inhaled gas MRI, which provides lung images with unprecedented~     spatial and temporal resolution. Our previous work demonstrated that inhaled gas MRI can~     provide significant clinical information for lung cancer radiotherapy planning and~     post-treatment evaluation. Building upon this unique experience, a multidisciplinary team~     will conduct an inhaled gas and proton lung MRI study that will address two of the major~     clinical problems faced by lung cancer patients treated with radiotherapy.~        1. Normal lung tissue is often damaged by the curative radiation dose. The investigators~          hypothesise that regional ventilation-perfusion lung function imaging with inhaled gas~          and proton MRI before and after treatment will help to lower the risk of~          radiation-induced lung injury and help to detect such damage at an early stage.~        2. Identification of the extent of cancerous tissue is error-prone when planning treatment~          from CT images alone. The investigators hypothesise that advanced proton MRI techniques~          will improve the identification of tumour volume, which is critical to successfully~          targeting the radiation dose.~      To achieve these goals, image acquisition and image processing methods will be tested with a~     study of 20 patients. Results from this study will make an important contribution to~     improving the treatment of lung disease which is one of the key research priorities of the~     NHS.~   "
130467|NCT01859637|"~     Purpose of the study is to investigate the safety, immunogenicity and the efficacy of~     Zarzio®/Filgrastim HEXAL® under chronic administration for 12 months in patients diagnosed~     with severe chronic neutropenia.~   "
130468|NCT01859624|"~     Albuterol is a drug approved by the US Food and Drug Administration (FDA) for treating~     breathing problems such as asthma. Studies have shown that albuterol may be beneficial in~     improving muscle function in people with late-onset Pompe disease. The purpose of this study~     is to evaluate whether albuterol is safe and effective for improving muscle function in~     people with late-onset Pompe disease, whether or not they are receiving enzyme replacement~     therapy (ERT). For this study, albuterol is considered an investigational drug. The word~     investigational means albuterol is not approved by the FDA for individuals with late-onset~     Pompe disease.~   "
130469|NCT01859611|"~     The study objective is to evaluate the safety and efficacy of a radiofrequency (RF) source,~     the TriActive+ RF handpiece, for treatment of wrinkles and rhytides after multiple~     treatments. The primary endpoint is observation of changes to the surface by visual and~     photographic analysis. Secondary endpoints: measurement of patient satisfaction and comfort~     of the treatment and the measurement of adverse events.~   "
130470|NCT01859598|"~     The scientific use of basal insulin is of great help to individuals and the government.~     However, there are few studies to investigate the real world use, effect, safety and~     influence factors of basal insulin in China. This study is to evaluate the use of first basal~     insulin in China patients with type 2 diabetes with inadequate glycemic control on oral~     antidiabetic agents (OADs) from the naturalistic clinical practice.~   "
130471|NCT01859585|"~     The purpose of this study is to evaluate the efficacy of Parecoxib and Ketorolac as a~     preemptive analgesia in patients undergoing lumbar spinal fusion.~   "
130472|NCT01859572|"~     The rationale for this study is to facilitate future Phase II/III clinical trials and improve~     outcome for patients suffering residual disability after an ischaemic stroke. Main study~     objectives are to document and better define the prognostic characteristics of residual~     disability in patients following an ischaemic stroke, to inform the design of small efficient~     Phase II studies when screening potentially efficacious interventions for signals of activity~     which merit further development and to establish a pool of patients who may be approached to~     participate in future clinical trials in the ischaemic stroke setting.~   "
130473|NCT01859559|"~     The primary objective of this randomized controlled trial (RCT) is to compare the success~     rate of obtaining peripheral vascular access with ultrasound guidance versus the traditional,~     landmark approach among patients with varying degrees of intravenous access difficulty. In~     addition to comparing overall initial success rates of the two methods, we will also compare~     the success rates by degree of intravenous access difficulty (3 main subject subgroups) and~     by operator experience (approximately 20 emergency department technicians).~      The main hypothesis is that the initial success rate will be significantly higher (5% or~     greater) for ultrasound guided peripheral intravenous access compared to landmark approach~     among patients who are judged to have difficult intravenous access but no significant~     difference (i.e. < 5%) among patients judged to have easy intravenous access.~   "
130474|NCT01859546|"~     Vaccines are one of the best public health tools available to achieve the Millennium~     Development Goal (MDG) # 4 of decreasing child mortality. A major reason for poor childhood~     vaccine coverage is the lack of awareness among parents regarding the need for immunization~     in children, and the importance of completing the entire series of vaccines. This result in~     significant drop-out between vaccines delivered at birth and later in the infancy period. New~     innovative methods involving technologies are needed to be employed to increase the vaccine~     coverage. This study is being conducted in Karachi, Pakistan and main study objective is~      • To assess the effectiveness of SMS reminders on cell phones in improving the compliance of~     subsequent visits for routine immunization for children.~   "
130475|NCT01859533|"~     Evaluating the effect of early application of Continuous positive airway pressure (CPAP) via~     Neopuff in cases of transient tachypnea of the newborn(TTN) and its role in decreasing the~     duration and complication of TTN.~   "
130476|NCT01859520|"~     Sperms are prepared by sperm washing techniques before used in assisted reproductive~     technologies. Most commonly used sperm preparation methods are the swim up and the density~     gradient. Recent studies shows that the DNA integrity status of the spermatozoa is related to~     the success in assisted reproduction techniques. Sperm preparation methods may theoretically~     cause damage to sperm DNA. Therefore it is important to select the optimum method of sperm~     preparation causing least sperm DNA damage. Aim of our study is to investigate and compare~     the effect two different sperm preparation techniques on DNA fragmentation.~   "
130479|NCT01859481|"~     Evaluation of headache response at 2 hours for active treated attacks for increasing dose.~   "
132740|NCT01829841|"~     -  Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1~          and Flt3. Phase I study has shown that the toxicity is manageable.~        -  The purpose of this study is to compare the efficacy and safety profile between~          Famitinib and Sunitinib in patients with metastatic renal cell carcinoma.~   "
130480|NCT01859468|"~     Amorphical has a strong basis to believe that the Amorphous Calcium Carbonate (ACC) product~     has an effect on active mineralization during bone remodelling hence, it has a potential to~     accelerate fracture healing process. The active mineralization can most probably be~     attributed to the mineral component of this substance.~      The distal radius fracture was chosen as the model to test the effects of ACC treatment~     because it includes both trabecular and cortical bone, is accessible for radiographs, has~     little soft tissue that can distort the radiograph, and is amenable to multiple functional~     endpoints.~      Primary objective:~      To assess the efficacy of treatment with calcium from ACC compared to placebo on radiographic~     healing time in subjects with distal radius fractures.~      Secondary objectives:~        -  To evaluate the effect of ACC compared to placebo on the improvement in wrist functional~          outcome following distal radius fracture.~        -  To evaluate the safety profile of ACC in this population~   "
130481|NCT01859455|"~     This study is designed to investigate the safety, tolerability, pharmacokinetics and~     pharmacodynamics of LGT209 in hypercholesterolemic patients taking common statin medications~     and in healthy volunteers.~   "
130482|NCT01859442|"~     The present study is a randomised control trial investigating the effects of a short six week~     exercise training program in rectal cancer patients following neoadjuvant chemoradiotherapy~     prior to elective rectal cancer surgery.~      Twelve patients will be randomised (1:1) to an intervention and a control group. The patients~     randomized to the intervention group will attend a total of 18 tailored exercise sessions~     (Three 40 minute sessions for six weeks) after their 6 weeks of chemoradiotherapy treatment.~     Where possible the exercise training sessions will be arranged to fit in with other~     appointments at the hospital. Patients randomized to the control group will be unsupervised.~     They will only attend an extra 3 sessions were a cardiopulmonary exercise test and VO2~     Kinetics test will be performed. Patients will also be invited to attend 3 health related~     quality of life interviews at week 0, 3 and 6 during their exercise programme. These~     appointments will be directly before or after their exercise sessions to minimise hospital~     attendence.~      Following surgery only routine clinically relevant observational data will be collected.~     These data will relate to hospital length of stay, the level of care required following~     surgery, post-operative morbidity survey (POMS) and the recovery process. Most of this~     information can be accessed from patient notes and on the electronic patient records system.~      This is a subgroup RCT of patients in a larger interventional trial (6 control and 6 exercise~     intervention patients) will be asked to consent separately for the the 31-Phosphorus Magnetic~     Resonance Spectroscopy (31P MRS) scans and the blood samples.~      HYPOTHESIS~        1. Interval exercise training will maintain or improve fitness (measured by anaerobic~          threshold) in patients undergoing neoadjuvant chemoradiotherapy.~        2. Interval exercise training is safe and feasible in patients undergoing neoadjuvant~          chemoradiotherapy awaiting rectal cancer resection.~        3. Interval exercise training will improve other measures of physical fitness measured in~          the CPET and the oxygen uptake kinetics test.~        4. Interval exercise training will improve quality of life in patients undergoing~          neoadjuvant chemoradiotherapy.~        5. Improvements in physical fitness will reduce postoperative complications following major~          rectal cancer surgery.~        6. Does physical activity, measured by Sensewear Pro 3 activity monitors, decrease during~          neoadjuvant chemoradiotherapy and can this decrease be attenuated by an exercise~          training program?~        7. Can we find an optimal time for surgery when fitness and cancer downstaging are at their~          best?~      HYPOTHESIS for Mechanism Pilot Study~        1. To explore the exponential rate constant of post-exercise phosphocreatine recovery.~        2. To explore the alteration in cellular and mitochondrial energetics eg. Change in~          mitochondrial numbers, change in mitochondrial activity and respiration.~   "
130483|NCT01859429|"~     The study will examine whether the provision of psychosocial support services for cancer~     patients in acute care can be optimized by the use of a structured combination of screening~     procedures with physician interviews and structured patient pathways.~      There is strong evidence that a third of all cancer patients in acute care are suffering from~     mental health conditions and that a third expresses the need for professional~     psycho-oncological support.~      However, physicians and nurses do not always identify these patients in need for support.~     Screening questionnaires are significantly better to identify distressed patients however the~     use of screenings alone does not necessarily improve the patients' emotional well-being.~      Purpose of this study is to evaluate a psychosocial stepped care model which aims to decrease~     the patients' distress.~   "
130484|NCT01859416|"~     Although oral nutritional supplements (ONS) are known to be effective to treat malnutrition~     in older persons, evidence from nursing home populations including demented residents is~     rare, especially with regard to functionality and well-being. A known barrier for ONS use~     among older persons is the volume that needs to be consumed, resulting in low compliance and~     thus reduced effectiveness.~      Thus, this study aimed to investigate the effects of a new, low volume, energy- and~     nutrient-dense ONS on nutritional status, functionality and quality of life of nursing home~     residents with malnutrition or at risk of malnutrition.~      In 6 nursing homes in Nuremberg and Fuerth, Germany, a standardized screening was performed~     to identify all residents with malnutrition or at risk of malnutrition who might possibly~     benefit from nutritional intervention. All subjects with either a Mini Nutritional Assessment~     (MNA®) score below 24 points, BMI ≤22 kg/m², a low food intake according to the nurses'~     perception or weight loss of ≥5% in the last 3 or ≥10% in 6 months, respectively, were~     invited to participate and asked for informed consent.~      Eligible residents with informed consent were randomly assigned to the intervention group~     (IG) which received two bottles of the ONS per day (250 mL, 600 kcal) in addition to usual~     nutritional care or to the control group (CG) which received usual nutritional care only.~      Assessment of nutritional parameters included body weight, BMI, arm- and calf-circumference~     and Mini Nutritional Assessment (MNA). Cognitive status, depression, activities of daily~     living, handgrip strength, gait speed and quality of life were examined using standardized~     instruments and protocols. All measurements and tests were performed at baseline, after 12~     and 24 weeks.~      Compliance and tolerance were documented daily by nursing staff and regularly controlled by~     the study team.~      Statistical analysis was performed following the intention-to-treat (ITT) approach including~     all residents originally assigned to either the IG or CG unless residents died during the~     study. A sample size calculation was performed with body weight as the primary outcome~     parameter (0.8 power to detect a significant difference p<0.05, two-sided) based on an~     estimated mean body weight 55 kg and a mean difference in body weight between the groups~     after 12 weeks of 1.5±2.2 kg comparable to results previously observed in this population. To~     detect a significant difference between IG and CG, 35 subjects were needed for each group.~     While sample size calculation aimed at ensuring adequate power to detect meaningful~     differences, the actual statistical analysis was of exploratory nature.~   "
130485|NCT01859403|"~     This study aims to determine if providing genomic information to veterans can help them lose~     weight compared to usual care.~   "
130486|NCT01859390|"~     The purpose of this study will be to evaluate the effects of a modified formulation of~     AquADEKs (AquADEKs-2) on markers of inflammation, antioxidant levels and oxidative stress.~      Cystic Fibrosis (CF) is a disease that affects the organs in the body such as the lungs. Some~     of the damage to the lungs of CF patients may be caused by something called~     oxidant/antioxidant imbalance and oxidative stress.~      Oxidation in the body is kind of what happens to an apple when it turns brown after being~     cut. And, just as a squeeze of lemon juice stops the oxidation of an apple, antioxidants can~     stop the rusting (or damage) inside our bodies by unstable oxygen molecules called free~     radicals. Free radicals can help fight off bacteria and viruses but too many of them do~     damage instead. Our bodies need antioxidants to keep things in balance so we have the right~     amount of free radicals.~      Many CF patients also have trouble digesting food and absorbing nutrients like vitamins. Many~     of the vitamins we rely on are antioxidants, like vitamins A, D, E, K and beta-carotene. In~     some people with CF, even though they take multivitamins and pancreatic enzymes, they still~     have low amounts of antioxidants. The investigators are looking to see if taking more~     vitamins and antioxidants will help CF patients.~      AquADEKs-2 is an investigational new drug (a drug that has not received approval by the Food~     and Drug Administration [FDA]). This research study is being done with the AquADEKs-2~     compared to a control multivitamin. The study drug, AquADEKs-2 contains standard amounts of~     fat-soluble vitamins (A, D, E, K) that are contained in typical CF multivitamin supplements~     plus several antioxidants including beta-carotene, mixed tocopherols (different forms of~     vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and~     the minerals zinc and selenium. The control multivitamin contains standard amounts of~     vitamins A, B, D, E, and K without additional antioxidant supplementation.~   "
130487|NCT01859377|"~     The purpose of this study is to evaluate the systemic exposure to ibuprofen after single~     oromucosal administration of the test product V0498 and single oral administration of a~     reference product.~   "
130488|NCT01859364|"~     Background:~      - The success rate for those who attempt to quit using tobacco products is only about 5~     percent. Many people who try to quit do so without seeking professional help. Several kinds~     of nicotine replacement therapy (NRT) are available without a prescription. However,~     prescription drugs and mental health counseling can also help people stop using tobacco.~     Combining NRT and/or medication with counseling can increase success rates. Researchers want~     to study what kinds of tobacco cessation treatments are most successful. This may help~     develop better treatments and determine who will respond best to them.~      Objectives:~        -  To provide treatment for tobacco use.~        -  To identify factors that affect how well people respond to treatment.~      Eligibility:~      - Individuals at least 18 years of age who are trying to stop using tobacco products.~      Design:~        -  This study will last up to 1 year. Treatment may last up to 36 weeks. Treatment may~          include counseling, NRT (patches and/or nicotine lozenges), or prescription medication~          (varenicline or bupropion). Treatment will be determined by a study doctor.~        -  Participants will also have three study visits at 4, 6, and 12 months after starting~          treatment. Each visit may take up to 2 hours. At the study visits, participants will~          have different kinds of tests. They will provide blood and urine samples, and have~          carbon monoxide breath tests. They will also fill out forms about mood and tobacco~          cravings.~        -  During treatment, participants will have clinic visits once or twice a week for~          counseling and to monitor tobacco use and withdrawal symptoms. Counseling sessions will~          work on dealing with tobacco cravings. Each visit may take up to 90 minutes.~   "
130489|NCT01859351|"~     The purpose of this study is to test the safety of escalating doses of the novel PI3K~     inhibitor WX-037 and to explore its effectiveness in combination with WX-554 which targets~     mitogen activated protein kinase (MEK1 and MEK2). Preclinical evidence indicates that these~     two novel compounds could provide targeted inhibition of both pathways to block tumour~     growth.~   "
130490|NCT01859338|"~     This clinical trial studies magnetic resonance imaging (MRI), cone beam computed tomography~     (CT), and fan beam CT in detecting soft tissue in patients with prostate and lung cancer~     undergoing radiation therapy. Comparing results of diagnostic procedures done before and~     during radiation therapy may help doctors predict a patient's response to treatment and help~     plan the best treatment.~   "
130491|NCT01859325|"~     Background:~      - In most people who have human immunodeficiency virus (HIV), the immune system cannot~     control or cure the infection. Antiretroviral therapy drugs can keep the amount of HIV virus~     low for a long time. However, this treatment does not remove the virus from the body. In the~     vast majority of patients antiretroviral therapy also will not protect the body from the~     virus once treatment stops. Researchers want to see if therapeutic vaccination can help~     people with HIV. Therapeutic vaccination means giving vaccines to treat an infection that~     someone already has (HIV, in this case). It may help the body's immune system attack the~     infection. This study will look at different measures of HIV infection after receiving either~     therapeutic vaccination or a placebo.~      Objectives:~      - To see whether therapeutic vaccination is safe and can affect how the body responds to HIV~     infection.~      Eligibility:~      - Individuals between 18 and 65 years of age who have HIV and are taking antiretroviral~     therapy drugs.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected.~        -  During the screening visit and throughout the study until week 56, participants will~          continue to take their HIV medications.~        -  Participants will be divided into two groups. One group will have the study vaccines.~          The other will have a placebo.~        -  The first study vaccine or placebo will be given in weeks 4, 12, and 36. The second~          study vaccine or the placebo will be given in weeks 24 and 48. Blood samples and other~          tests will be given at each visit.~        -  After the study visit at week 56, participants will stop their HIV medications until~          week 72. From weeks 58 through 72, they will come in every 2 weeks for study visits;~          each visit will take about 1 hour to complete. These visits will look at the body s~          response to the vaccines and their HIV viral load. After week 72, participants will~          re-start their HIV medications.~        -  There will be follow-up study visits from weeks 76 to 96, with blood tests and other~          studies.~   "
130492|NCT01859312|"~     Background:~        -  Congenital adrenal hyperplasia (CAH) is a genetic disorder of the adrenal gland. The~          adrenal gland is located in the abdomen and produces small amounts of hormones such as~          cortisol, aldosterone, and androgen. These hormones help control blood pressure, protect~          the body, and maintain good health, especially during development. People with CAH do~          not make enough cortisol and aldosterone, and make too much androgen. This can lead to~          serious medical problems. The standard treatment is to take pills that mimic the effects~          of cortisol and aldosterone. However, treatment with pills can have long-term side~          effects because of the higher doses needed, and may not work well for some people.~        -  A possible new treatment for CAH is to use a pump to deliver cortisol under the skin.~          Similar pumps are often used to give insulin to people with diabetes. Researchers think~          that a cortisol pump might be able to help the body use the cortisol more effectively~          than taking pills. They want to compare the results of a cortisol pump and standard pill~          treatments for CAH.~      Objectives:~      - To compare the effectiveness of a cortisol pump with standard cortisol pill therapy for~     CAH.~      Eligibility:~      - Men and women at least 18 years of age who have CAH (see more details in Eligibility~     section below).~      Design:~        -  This study will involve four inpatient hospital stays at the National Institutes of~          Health in Bethesda, MD over 6 months (spaced 2 months apart). The first and last stays~          will last about 5 days. The second and third stays will last about 3 days.~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected.~        -  At the first study visit, participants will provide regular blood and urine samples.~          They will also have imaging studies. These studies will look at the bones, fat, and~          muscles in the abdomen and pelvis.~        -  Participants will receive a cortisol pump during the first visit. They will be shown how~          to use the pump. They will also learn what to do, if they need to take extra stress~          dose cortisol pills.~        -  At the second and third visits, the cortisol dose given with the pump will be adjusted~          as needed. Blood and urine samples will also be collected. No imaging studies are~          scheduled for these visits.~        -  The last study visit will have the same tests as the first visit. Participants will be~          offered the chance to continue with the pump treatment for 1 more year, or go back to~          their standard pill treatment.~      Study type: Interventional non-randomized trial~      Official title: A Pilot Study Assessing the use of Continuous Subcutaneous Hydrocortisone~     Infusion In the Treatment of Congenital Adrenal Hyperplasia~      Estimated enrollment: 8~      Study Start Date: May 2013~      Estimated Study Completion Date: December 2016~      Sponsoring Institute: National Institute of Child Health and Human Development~      <TAB>ELIGIBILITY~      Inclusion criteria~        1. Men and women 18 years of age or older with classic congenital adrenal hyperplasia~          (21-Hydroxylase deficiency)~        2. High adrenal androgens in the blood, and~        3. One or more of the following conditions: obesity, fatty liver, risk for diabetes, low~          bone mass, inability to tolerate cortisol pills~      Exclusion criteria~        1. Pregnancy~        2. Breast feeding~        3. Use of inhaled or oral steroids for diseases other than CAH~        4. Use of estrogen-containing birth control pills~        5. Use of medicines that cross-react with hydrocortisone~        6. Use of stress dose steroids for illness during the last 30 days prior to joining the~          study~   "
130493|NCT01859299|"~     Background:~      - Uveitis is a general term describing a group of inflammatory diseases of the eye. The~     causes of uveitis are not fully understood. Researchers want to look at bacteria in the body~     that might be related to the inflammation. They will study the natural bacteria present in~     the gut and intestines of people with and without uveitis to understand their potential role~     in these diseases.~      Objectives:~      - To study the intestinal bacteria in people with and without uveitis or ocular inflammatory~     disease.~      Eligibility:~        -  Individuals at least 18 years of age who have uveitis or ocular inflammatory disease.~        -  Individuals at least 18 years of age without uveitis or ocular inflammatory disease to~          serve as healthy controls.~      Design:~        -  Participants may have more than one study visit (approximately 2-4) to assess possible~          changes in microbiome composition associated with treatment or disease activity.~        -  At each visit, participants will have a full eye examination, including vision and eye~          pressure tests. They will provide blood samples for testing. Participants will also be~          provided a stool collection kit to take home. The samples may be sent or brought back to~          the clinic.~        -  Treatment will not be provided as part of this study.~   "
130494|NCT01859286|"~     The investigators sought to determine if implementing a standardized sign out process would~     reduce the amount of medical errors related to patient sign out. The standardized process~     included the following interventions: implementation of a data resident to review patients~     lab values, vital signs, radiologist results, and orders in real time, conducting sign out in~     a standardized location and using the attending physician as an interruption manager. The~     investigators defined medical errors related to sign out as any piece of information was~     incorrectly reported or omitted during sign out that caused a change in treatment or~     disposition discussed during sign out. The investigators hypothesis was that implementing a~     standardized sign out process would lead to a decrease in the amount of sign out related~     errors.~   "
130495|NCT01859273|"~     Despite significant advances in the care of kidney transplant recipients, long term graft~     survival after renal transplantation remains suboptimal. Medication nonadherence and clinical~     inertia are key contributors to graft loss. The purpose of the proposed RCT feasibility study~     is to evaluate impact of a bundled wireless real time medication reminder system and blood~     pressure monitoring system in combination with a cognitive behavioral adherence skills~     enhancement program upon medication adherence, therapeutic drug concentration, and blood~     pressure, in nonadherent kidney transplant recipients with hypertension. We propose to~     recruit 60 kidney transplant recipients in phase 1 with 20 non-adherent continuing to phase 2~     for a 5-month feasibility RCT.~   "
130518|NCT01858961|"~     The aim of this trial is to evaluate efficacy and safety of treatment with 600 mg of BID BI~     207127 in combination with 120 mg QD Faldaprevir and RBV compared to a Telaprevir-based~     regimen along with PegIFN and RBV in chronically infected HCV GT1 treatment naïve patients,~     including patients with compensated cirrhosis.~   "
130496|NCT01859260|"~     Obstructive sleep apnea (OSA) is a common and undertreated condition in patients with chronic~     kidney disease (CKD). Both physiologic and empiric data suggest that renal hypoxia due to OSA~     is associated with worsening kidney function. Hospitalized patients are often exposed to~     multiple nephrotoxins such as antibiotics, contrast agents, and diuretics, which place them~     at risk for acute worsening of kidney function. This study aims to determine whether~     immediate diagnosis and treatment of OSA in CKD patients will decrease the incidence of acute~     kidney injury during hospitalization. The investigators will evaluate the extent to which~     this effect can be attributed to a decrease in nocturnal hypoxia and improved blood pressure~     control. Secondary endpoints include hospital length of stay, and a composite outcome~     comprised of hemodialysis initiation, major cardiovascular events, and mortality.~   "
130497|NCT01859247|"~     The overall objective of this application is to therapeutically target the dysfunctional~     premotor-motor interaction in dystonia—and to provide a focused treatment of specific~     anatomical networks in order to reduce side effects and to improve symptom control over~     conventional therapies.~   "
130498|NCT01859234|"~     The purpose of this study is to see whether 89Zr-bevacizumab PET scanning is feasible in~     relapsing multiple myeloma patients.~   "
130499|NCT01859221|"~     The purpose of this phase II study is to evaluate the outcomes of patients treated with an~     investigational radiation regimen using stereotactic radiotherapy for oligometastatic~     prostate cancer and to establish efficacy (producing a desired result or effect) and safety~     in this setting.~   "
130500|NCT01859195|"~     The purpose of this project is to explore women's thoughts, opinions, and ideas about vaginal~     products. The investigators will ask women to help design the best strategy for applying a~     vaginal product using a specific kind of applicator. The investigators want to identify~     designs that women think would be easy to prepare and insert. Women's thoughts and opinions~     will help researchers develop new products called microbicides that may protect against HIV~     and other sexually transmitted diseases, that are easy to use, and that will be acceptable to~     women who use them. If researchers can make products that are easy to use and that women like~     to use, the products will be used more often, and more infections will be prevented.~      Women who enroll in the project will either participate in a focus group with approximately~     3-7 other women or a one-on-one cognitive interview. All participants will complete a brief~     questionnaire. Some women may enroll in both stages.~      Each focus group will take approximately 1.5-2.5 hours. Group leaders will talk to women~     about their experiences using vaginal products and will provide participants with study~     products to look at and touch. All participants will be asked to come up with ideas of how to~     make the products easy to use and acceptable to women who use them. Group leaders will~     encourage discussion about the different designs. After this, group leaders will talk about a~     specific type of microbicide and ask women about their opinions. In particular, researchers~     and participants will talk about the language that would be best understood by women who~     would use these products or be in studies to evaluate them.~      Each cognitive interview will take approximately 1.5-2.5 hours. Each participant will be~     asked about different product designs and application instructions, and will be asked her~     thoughts, opinions, and potential concerns about each. She will also evaluate sample language~     that will be used to help women understand the products and how to use them.~   "
130501|NCT01859182|"~     This phase II trial studies how well selumetinib and Akt inhibitor MK-2206 work in treating~     patients with refractory or advanced gallbladder or bile duct cancer that cannot be removed~     by surgery. Selumetinib and Akt inhibitor MK-2206 may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth.~   "
130502|NCT01859169|"~     This research is a prospective randomized controlled trial.It aimed to determine longterm~     outcomes and factors associated with increased survival after photodynamic therapy (PDT)~     through T-tube compared with biliary drainage alone in patients presenting with unresectable~     bile duct cancer.~   "
130503|NCT01859156|"~     The purpose of this study is to determine whether a relationship exists between EtCO2 and~     carboxyhemoglobin levels in carbon monoxide exposure. Our hypothesis is that a liner~     relationship exists between EtCO2 and carboxyhemoglobin in carbon monoxide poisoning.~   "
130504|NCT01859143|"~     This prospective annual release study is designed to evaluate the safety on new influenza~     virus vaccine strains to be included in FluMist Quadrivalent for the 2013-2014 influenza~     season.~   "
130505|NCT01859130|"~     The primary objective of this study is to obtain implant survivorship and clinical outcomes~     data for commercially available Persona fixed bearing knee implants used in total knee~     arthroplasty. The assessment will include implant survivorship and clinical performance~     measured by pain and function, quality of life data, radiographic parameters and~     survivorship.~   "
130506|NCT01859117|"~     This clinical study is being conducted to assess the safety and determine the maximum~     tolerated dose (MTD) of PDA-002 [human placenta-derived cells] administered into the lower~     leg muscles of subjects with peripheral arterial disease and diabetic foot ulcers. It will~     look to see if PDA-002 helps reduce some of the symptoms of PAD and/or improves ulcer~     healing. This study will also help to find the best dose of PDA-002 to use in future studies.~   "
130507|NCT01859104|"~     This current study aims to evaluate the efficacy of engagement modules in assisting patients~     who are candidates for renal and liver transplantation make significant lifestyle~     modifications. With the help of the Center for Innovation (CFI), a smartphone app (Android~     and iOS compatible) has been created to assist in both educating and engaging patients to~     develop and maintain healthy lifestyle modifications. Our goal is to create a cost-effective,~     smartphone-based platform that serves to not only efficiently educate but to also verify~     competence and keep our patients engaged.~   "
130508|NCT01859091|"~     The purpose of this study is to evaluate the safety and feasibility of cryolipolysis for~     non-invasive reduction of submental fat.~   "
130509|NCT01859078|"~     The purpose of this study is to determine the effect of baricitinib on the levels of digoxin~     in the blood stream and how long it takes the body to remove digoxin. This study will also~     look at how safe and well-tolerated baricitinib is when given at the same time as digoxin in~     healthy participants. This study will last approximately 3-4 weeks.~   "
130519|NCT01858948|"~     The investigators will test the hypothesis that the adverse effects of second-generation~     antipsychotics exposure and the beneficial effects of long-chain omega-3 (LCn-3) fatty acids~     are mediated by opposing effects on the enzyme implicated in the metabolic syndrome and~     obesity.~   "
130520|NCT01858935|"~     This study is to evaluate the safety, tolerability, and pharmacokinetics of ND-L02-s0201 in~     normal, healthy, subjects~   "
130529|NCT01858818|"~     This project aims to investigate how dysfunctional learning and habitization are affected by~     acute alcohol exposure, and whether individual differences in such alcohol effects can~     predict later development of Alcohol Use Disorders (AUDs). Eighty 18-year-old healthy male~     subjects are tested on two days in a within-subjects design with blinded administration of~     alcohol vs. placebo and different behavioral and learning tasks. The investigators~     investigate how alcohol influences the performance during these tasks, whether alcohol~     effects differ between high- and low-risk subjects, and whether task performance under~     alcohol predicts future AUDs.~   "
130510|NCT01859065|"~     Kennedy et al, in a study of pediatric Emergency Department (ED) use by newborns less than 14~     days of age, revealed that half of all visits in this population were non-acute problems.~     Other pediatric ED utilization studies have shown similar findings in that 32% to 72% of all~     visits were for non-urgent problems.~      Many studies have found that primiparity and young maternal age are associated with non-acute~     ED presentations. A recent factor that has been investigated is the effect of early neonatal~     discharge. Some other factors are nonwhite mothers and mothers on Medicaid. Zandieh et al,~     found additional predisposing determinants for non-urgent ED visits, such as single~     parenthood, Hispanic ethnicity, and having perceptions that their child's overall physical~     health was poor.~      Paradis et al found that parents receiving a video intervention rated higher confidence with~     specific infant care skills and reported feeling better prepared to care for their baby,~     compared to parents receiving only handouts. However, there isn't any reported study that~     evaluates the benefits of receiving both, a video intervention along with handouts.~      Aim: to demonstrate whether conducting anticipatory guidance related to non-urgent problems~     will reduce non-urgent ED visits, compared to care as usual (CAU) anticipatory guidance~     (Sudden Infant Death Syndrome and Shaken Baby Syndrome videos; and unstructured talk about~     jaundice, vaccinations, appointments, care of umbilical stump, normal urination and bowel~     movement, fever).~   "
130511|NCT01859052|"~     The purpose of this study is to look at two different diets (a low carbohydrate diet and a~     low fat diet) for migraine prevention in overweight or obese persons with migraine. The~     overall aim is to test the theory that diet will improve migraine frequency and that such~     improvements will be associated with favorable changes in body weight, inflammation, and~     heart health.~   "
130512|NCT01859039|"~     Egg allergy is common in early childhood, affecting at least one in 50 preschool children.~     Influenza ('flu) vaccines contain egg protein, as the vaccine is cultured in hen's eggs.~     There is robust data to support the safety of influenza vaccines (containing low or~     negligible amounts of egg protein) in patients with egg allergy.~      A new influenza vaccine, known as LAIV (Live Attenuated Intranasal Vaccine) has recently been~     approved by a number of licensing boards and is given by a spray into the nose. This new~     vaccine has been available in the United States for several years and is highly effective and~     against influenza infection, with an excellent safety profile in children without egg~     allergy. However, LAIV is also grown in hen's eggs and contains egg protein, and there are NO~     existing data on the safety of LAIV in egg-allergic children.~      The objective of this multicentre study is to assess the safety of intranasal LAIV in~     egg-allergic children, in order to demonstrate that these children can safely be given the~     new LAIV within a primary care health environment.~   "
130513|NCT01859026|"~     The main purpose of this study is to find out if the drugs MEK162 and erlotinib (Tarceva)~     given in combination are safe and have beneficial effects in patients who have NSCLC.~      The U.S. Food and Drug Administration (FDA) has not approved MEK162 for use to treat NSCLC.~     Erlotinib is an FDA approved drug for the treatment of Non-Small Cell Lung Cancer.~   "
130514|NCT01859013|"~     The prevalence of severe pediatric obesity is on the rise and youth with this condition are~     at elevated risk for developing chronic diseases such as cardiovascular disease (CVD) and~     type 2 diabetes mellitus (T2DM). Topiramate, a medication approved by the Food and Drug~     Administration (FDA) for the treatment of seizures in adults and children, is associated with~     weight loss. Although not FDA approved for the treatment of obesity, studies in obese adults~     have demonstrated weight reduction of approximately 5% with 6-12 months of therapy. However,~     the weight loss effect of topiramate has never been evaluated among children and adolescents.~     Therefore, the goal of this pilot study is to evaluate the safety and efficacy of 24 weeks of~     topiramate therapy with a 4-week run-in of meal replacement therapy in adolescents with~     severe obesity. The primary hypothesis is that 4 weeks of meal replacement therapy followed~     by 24 weeks of topiramate will have a larger average percent decline in BMI between baseline~     and 28 weeks compared to meal replacement therapy followed by placebo.~   "
130515|NCT01859000|"~     This protocol seizes this rare scientific opportunity to test an integrative family based~     model to address youths' coexisting substance abuse and trauma in the wake of Hurricane~     Katrina. The study would address a number of gaps in the current evidence base related to~     understanding and treating comorbid teen drug abuse and trauma that may be initiated or~     exacerbated in the wake of disasters such as Hurricane Katrina. This study would compare two~     promising interventions for youth with comorbid trauma and substance abuse, family-based~     treatment and group Cognitive Behavioral Therapy (CBT), potentially yielding new and vital~     information about effective treatment for substance abusing youth following traumatic events.~   "
130516|NCT01858987|"~     The optimal technique of parenchymal transection in liver surgery has remained a matter of~     controversial debate among hepatobiliary surgeons. The optimal technique should enable secure~     sealing of the vascular and biliary structures that results in low intraoperative blood loss~     as well as low postoperative complication rates. Although numerous devices have been~     introduced and are used widely, high-level evidence, randomized controlled trials, that~     evaluate efficacy and safety of these devices are scarce. In the present randomized~     controlled trial two techniques of hepatic resection using vascular staplers and the LigaSure~     vessel sealing device are compared. While the primary endpoint is intraoperative blood loss a~     set of general and surgical variables will be analyzed to evaluate efficacy and safety of~     both methods.~   "
130517|NCT01858974|"~     With this study the investigators want to determine, if a fast identification of germs,~     causing infections of the lower respiratory tract, is possible through the use of Multiplex~     PCR technology - a method that allows on time detection of bacteria in medical specimen by~     identifying DNA sequences that are known to be specific for the respective microbe. Therefore~     aspiration samples from the respiratory tracts of ventilated patients, which are suspected to~     develop such an infection, will be collected and analyzed by using a multiplex PCR~     (polymerase chain reaction) application situated on the intensive care unit. The~     investigators want to determine if Multiplex PCR diagnostic could be a faster alternative to~     conventional microbiological methods. The results of the Multiplex PCR analyses therefore~     will be compared with results of conventional microbiological methods.~   "
130530|NCT01858805|"~     Despite the availability of several preoperative diagnostic techniques, accurate pretreatment~     staging of esophageal cancer (EC) remains challenging. Therefore, The investigators evaluated~     the prognostic significance of circulating tumor cells (CTCs) in patients with EC.~   "
130521|NCT01858922|"~     Subjects have a type of cancer called Hodgkin Disease (HD), a cancer of the lymph system. The~     lymph system is made up of tissue throughout the body that makes and stores~     infection-fighting cells. HD is one of the most treatable childhood cancers. The standard~     treatment for HD involves chemotherapy (treatment with anti-cancer drugs) and radiation~     therapy (the use of high-dose x-rays to get rid of cancer cells). Although they are cured~     from their cancer, some patients experience negative side effects from treatment later in~     life. These kinds of side effects are often referred to as late effects. This can include~     problems with growth, problems with some organ functions, and sometimes second cancers. These~     types of effects can be associated with either chemotherapy or radiation therapy. The~     investigators are therefore designing studies to minimize or prevent these late effects. It~     is thought that if some patients can be successfully treated without radiation, those~     patients might experience fewer late side effects.~      Some patients, however, do not respond as well to the first stages of treatment (slow early~     responders). Slow early responders are considered to be at higher risk for relapse. This~     study also looks at whether these kinds of patients will benefit from additional~     chemotherapy.~      The purpose of this study is to look at how the immune system recovers and at how certain~     T-cells in the blood behave after receiving chemotherapy with or without radiation. The~     investigators also want to identify if bio-markers (special proteins in blood and in cancer)~     relate to the response of HD to study treatment.~   "
130522|NCT01858909|"~     OBJECTIVES. To establish the therapeutic efficiency of melatonin in adult patients with~     severe sepsis and septic shock.~      Specifically:~        1. To evaluate the survival to 28 days of mechanical assisted ventilation, days with~          vasoactive drugs, need of hemodialysis-hemofiltration, superinfection and evolution~          towards the failure of other organs.~        2. To evaluate, waiting for reduction under the influence of the treatment with melatonin,~          :~             1. clinical - analytical parameters of sepsis;~             2. levels of cytokines;~             3. oxidative and nitrosative stress;~             4. acute-phase proteins (APP), specially of the ITIH4;~             5. immune response;~             6. endocrine response.~      METHODOLOGY. Patients will be randomized in two groups, n = 55 in each group: 1) treatment~     with melatonin 30mg/12 hours 28 days; 2) placebo.~      Determinations: a) clinical - analytical parameters relative to the sepsis; b) melatonin~     plasmatic levels; c) quantification of malonyldialdehyde and 4-hydroxynonenal, protein~     carbonyl content, nitrites, erythrocyte membrane fluidity, and superoxide dismutase,~     catalase, glutathione reductase and glutathione peroxidase activity; d) Interleukins-1,2,4,5,~     6, 7,8,10,12,13, IFN-γ; TNF-α and GM-CSF; e) acute-phase proteins: PCR, haptoglobin, Apo A-I,~     α1-GPA and ITIH4; f) lymphocytes T, B, NK, T CD4, and T CD8, and immunoglobulins; g)~     cortisol, aldosterone, ACTH, ADH, insulin, glucagon and 25-hydroxyvitamin D3. Data will be~     analyzed following a prospectively define plan and by intention-to-treat (ITT) analysis.~   "
130523|NCT01858896|"~     Low blood sugar can negatively affect how blood vessels function, and this can lead to an~     increase in the risk for heart attacks, strokes and other problems related to the stiffening~     and blockage of blood vessels. The purpose of this study is to learn if and how glucagon-like~     peptide-1 (GLP-1; a naturally occurring hormone in the gut) changes the effects that low~     blood sugar levels have on blood vessels.~   "
130524|NCT01858883|"~     Test the hypothesis that itacitinib (INCB039110) can be administered safely in combination~     with gemcitabine and nab-paclitaxel in subjects with advanced or metastatic cancer.~   "
130525|NCT01858870|"~     Lacosamide is an antiepileptic drug approved for using like adjuvant treatment in adults~     epileptic crisis.~      Previous studies has granted to the adjuvant therapy a significant efficacy. This is an~     observational study, multicenter and retrospective, in patients with epilepsy. The aim of~     study is the evaluation of the adjuvant treatment with Lacosamide administered over 12~     months.~      The investigators will collect information from 860 patients in 13 spanish centers.~      The secondary aim is assess the tolerability of treatment during 3,6 and 12 month.~   "
130526|NCT01858857|"~     The purpose of this observational multicenter-study is to investigate safety of~     psychopharmacological treatment and rates of adverse drug reactions in gerontopsychiatric~     inpatients. Elderly people are at higher risk for developing side effects under~     pharmacological treatment due to an altered metabolic situation, higher comorbidity rates and~     often polypharmacy. Furthermore gerontopsychiatric patients can often not articulate their~     symptoms clearly, for example due to pronounced cognitive impairment.~      The aim of the study is to gain valid data of possible adverse drug reaction rates, their~     potential risk factors and outcome, as well as medical prescription practises.~      To assess these outcomes an intensive pharmacovigilance-monitoring will be conducted at the~     five participating study sites.~      At Baseline demographic data, previous and present disorders, use of drugs, previous and~     present medication, quality of life, cognitive function, physical examination results,~     laboratory results and ECG will be assessed.~      Afterwards patients are visited weekly and screened for possible adverse drug reactions. All~     adverse drug reactions will be coded in the MedDRA-system.~      In case of a possible serious adverse drug reaction serum levels of all psychotropic~     substances applicated will be assessed. Drug combinations will be analysed using an~     established advanced bioinformatic tool (mediQ). Diagnosis, medication intake and possible~     adverse drug reactions are documented continually.~      2 weeks after discharge from the ward, patients will be contacted by phone to assess~     catamnestic data.~   "
130527|NCT01858844|"~     Evaluate the effect of chest manual compression technique (CCT) in the variables of~     oxygenation, hemodynamic and respiratory work in infants with respiratory diseases that are~     associated with atelectasis.~   "
130528|NCT01858831|"~     This study will be a single-center, phase I, randomized, open, in fed condition, parallel,~     single dose study to evaluate the pharmacokinetics and the safety, tolerability of~     Atovaquone/proguanil combination tablets and atovaquone suspension in Japanese healthy male~     subjects.~      Serial blood samples will be collected for the determination of the plasma concentration of~     atovaquone, proguanil and cycloguanil after dosing of atovaquone 1000mg/proguanil 400 mg and~     the plasma atovaquone concentration of atovaquone 750 and 1500 mg. Safety assessments will be~     performed for each treatment group.~      CYP2C19 contribute to proguanil metabolism. CYP2C19 genotype will be determined in~     atovaquone/proguanil dosing group.~   "
130531|NCT01858792|"~     Efficacy and Safety of Belimumab in a Subgroup of Systemic Lupus Erythematosus (SLE) Patients~     with Higher Disease Activity (anti-dsDNA positive and low complement): A Pooled Analysis of~     the HGS1006-C1056 (BLISS-52) and HGS1006-C1057 (BLISS-76) Studies~   "
130532|NCT01858779|"~     Atrial fibrillation (AF) is the most common cause of cardioembolism and a leading cause of~     ischemic stroke. The diagnosis of AF after cerebral ischemia is difficult to establish even~     during the treatment at specialised stroke units, as paroxysmal episodes may terminate~     spontaneously before arrival at the hospital and do not always show early recurrence.~     However, the diagnosis of AF is of particular clinical relevance since adaequate~     anticoagulation is one of the most effective secondary preventive treatments in stroke. The~     detection rate of AF after stroke increases progressively by extending the duration and~     intensity of cardiac monitoring. For this purpose innovative medical devices and implantable~     event recorders have been suggested. However, high socioeconomic expenses, malcompliance and~     the invasiveness of some of these approaches currently limit their use to a minority of~     affected patients, while the growing number of stroke survivors is lacking access to free and~     simple screening tools.~      For primary prevention, the measurement of the peripheral pulse (MPP) is currently the only~     guideline-recommended screening method among individuals aged 65 years or older. In contrast,~     MPP has never been applied in the setting of secondary stroke prevention, probably because~     several factors were expected to interfere with this simple technique, including sensomotor~     and neuropsychiologic handicaps of stroke patients 18. This study investigates feasibility~     and validity of MPP in this cohort (pilot phase) and compares daily MPP for 6 months with~     repeated holter-ECG in patients after ischemic stroke.~   "
130533|NCT01858766|"~     The primary objectives of this study are to evaluate the antiviral efficacy, safety, and~     tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV)~     in treatment-naive adults with chronic genotype (GT) 1, 2, 3, 4, 5, or 6 hepatitis C virus~     (HCV) infection.~   "
130534|NCT01858753|"~     This Phase II, double-blind, randomized, placebo-controlled pilot study is designed to~     determine whether injection of autologous fibroblasts can increase the mobility (decrease the~     restriction) of burn scars. The study will assess the effects of azficel-T (autologous~     fibroblasts) in subjects who have a unilateral burn scar that is no deeper than the fascia~     (i.e., underlying structures including ligament, tendon, muscle, and bone must not contribute~     to the restriction) and that is either:~        1. An axillary scar causing 20-60% restriction of shoulder adduction~        2. An anterior elbow scar causing 20-60% restriction of elbow extension~        3. A dorsal or palmar lesion of a single finger causing 20-60% restriction of flexion or~          extension~      Subjects will each receive 2 injections of azficel-T or placebo administered 14 days (± 7~     days) apart (depending on cell availability) and will be followed for efficacy (including~     range of motion measurements, scar pain and ability to perform activities) to Visit 7 and for~     safety to Visit 9 at 1 year.~   "
130535|NCT01858740|"~     This phase II trial studies how well T cell depleted donor peripheral blood stem cell~     transplant works in preventing graft-versus-host disease in younger patients with high risk~     hematologic malignancies. Giving chemotherapy and total-body irradiation before a donor~     peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop~     the patient's immune system from rejecting the donor's stem cells. When the healthy stem~     cells from a donor are infused into the patient they may help the patient's bone marrow make~     stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted~     cells from a donor can make an immune response against the body's normal cells. Removing a~     subset of the T cells from the donor cells before transplant may stop this from happening.~   "
130536|NCT01858727|"~     30 patients American society of anesthesiology (ASA) physical status I,II and III undergoing~     general anesthesia for elective transurethral resection of the prostate (TUR-P) surgery will~     be included in the study. Patients will be randomized into two groups; first group(control~     group) and second group (forced-air warming). Resistive heating will start when patients are~     transferred to the operating room table; forced-air warming will start before preoperative 30~     minute.~   "
130537|NCT01858714|"~     The major goal of this project is to evaluate an innovative approach to obesity involving~     modification of the home environment. The project also will evaluate if home environment~     modification is more effective when supplemented with distress tolerance and related skills~     training.~   "
130538|NCT01858701|"~     The purpose of this study is to compare the amount of coma as measured by aberrometry induced~     by two silicone hydrogel toric lenses in astigmatic participants.~   "
130539|NCT01858688|"~     Some men newly diagnosed with prostate cancer do not require immediate treatment. Rather,~     they can be followed closely with regular physical exams, blood work and repeated biopsies of~     the prostate. If the prostate cancer is becoming more aggressive, curative treatment can be~     offered at that time. This strategy of delaying treatment until necessary is called active~     surveillance in prostate cancer.~      Active surveillance is a way of monitoring prostate cancer which aims to avoid or delay~     unnecessary treatment in men with less aggressive cancer.~      Prostate cancer can be slow growing and, for many men, the disease may never progress or~     cause any symptoms. In other words, many men with prostate cancer will never need any~     treatment. Treatments for prostate cancer may cause side effects which can affect your~     quality of life. By monitoring the cancer with regular tests, you can avoid or delay these~     side effects.~      Active surveillance is generally suitable for men with low risk early stage prostate cancer~     that is contained within the prostate gland (localized prostate cancer).~      If doctors had a better way of identifying who might be best suited for this approach, it~     would likely become more appealing for more men. In this study, the investigators are looking~     at how accurate a magnetic resonance imaging (MRI) scan is at identifying high-risk prostate~     cancer, which might make a man a poor candidate for active surveillance.~      To do this, the investigators are collecting data from the MRI scan of men and comparing it~     to a trans-rectal biopsy performed following the scan. The results of this study will help~     inform doctors how accurate the MRI is in identifying men who should not be on active~     surveillance.~   "
130540|NCT01858675|"~     The purpose of this study is to determine whether the Biomarkers (pro adrenomedullin (MR~     proADM), pro arginin vasopressin (CT proAVP), pro atrial natriuretic peptid (MR proANP), Pro~     Endothelin) changes at Day 2, Day 5 and Day 7 of ICU admission are correlated with~     Intravascular volume assessed by Cr 51 on red blood cells (Day 2 and Day 7) and by I 125 on~     albumine Day 7. The correlation of these Biomarkers are also evaluted with other markers such~     as erythropoietin and catecholamines. 80 ICU patients are included.~   "
130546|NCT01858597|"~     Gestational diabetes mellitus (GDM) is the most common complication in pregnancy. Both mother~     and offspring have a significantly increased future risk for metabolic and cardiovascular~     disease as a consequence of GDM. Pathological insulin resistance and the pancreatic β-cell~     dysfunction may contribute to the development and adverse outcomes of GDM.~      Recently, fibroblast growth factor 19 (FGF19) and FGF21 have emerged as key endocrine~     regulators of glucose, lipid and energy metabolism. Both factors activate FGFRs in the~     context of co-receptor βKlotho(KLB) expression. After that, both proteins alter ERK~     phosphorylation and stimulate glucose uptake. Furthermore, these two factors ameliorate~     insulin resistance through various ways including up-regulating insulin mRNA, IRS-1, GLUT-1~     expressions, down-regulating GH-IGF-1 levels in different tissues and blood circulation and~     also improving dyslipidemia.~      Our previous studies showed that several factors which involved in insulin resistance and~     FGF19/FGF21 signaling pathway had differential expression in placenta from GDM and normal~     glucose tolerance pregnancy. Those led us to hypothesize that FGF19/FGF21 signaling pathway~     could play an important role in the pathogenesis and development of insulin resistance state~     in GDM.~      In the present study, we will further investigate whether maternal and neonatal FGF19/FGF21~     signaling pathway are altered and associated with insulin resistance, glucose intolerance,~     dyslipidemia and adverse pregnancy outcomes. Thus we will evaluate the regulating action of~     FGF19/FGF21 on gestational insulin resistance.~      The aim of this study is to elucidate the role of FGF19/FGF21 in insulin resistance and~     metabolic disorder in GDM.~   "
130547|NCT01858584|"~     The results on the efficacy of the formulations based on alginic acid are controversial.~     Corvaglia et al demonstrated a significant reduction in reflux episodes in preterm infants by~     evaluation with pH-impedance analysis. This study concludes that the use of alginic acid~     reduces the acidity of the gastroesophageal reflux (GER) and has a non-systemic effect and a~     lesser presence of side effects compared to the use of H2-receptor antagonist(H2RA) and~     proton pump inhibitor (PPI).~   "
130548|NCT01858571|"~     Many of the pediatric malignancies are not curable on progression on front line or 2nd line~     chemotherapy. Further therapy with conventional drugs imposes many side effects and decreases~     the QOL. The usual therapy offered to such patients is best supportive care.~      Metronomic chemotherapy can induce tumor stabilization or tumor responses in patients with~     cancer that are refractory or have relapsed after conventional chemotherapy. Whether~     metronomic therapy is better than best supportive care is not known. In order to do so, a~     study is required which may compare metronomic therapy with a placebo therapy on PFS and QOL~     in relapsed refractory cases of pediatric solid tumors who have failed at least two lines of~     chemotherapy.~      HYPOTHESIS~      The investigators hypothesize that metronomic chemotherapy in progressive pediatric~     malignancy will improve PFS and QOL. If validated, then this form for therapy will be an~     option for both the patients and the clinicians, who are left with just an option of best~     supportive care in such situations of progressive pediatric cancers despite multiple lines of~     chemotherapy.~   "
130549|NCT01858558|"~     This research is being done to find out if altering the immune system by giving Prevnar~     vaccine, Tadalafil, and activated marrow infiltrating lymphocytes (MILs) can improve outcomes~     for multiple myeloma patients who receive a standard autologous stem cell transplant.~   "
130550|NCT01858545|"~     The primary objective of this study is to assess the effectiveness of MatriStem devices~     compared to cellular dermal replacement tissue, for the treatment of non-healing diabetic~     foot ulcers.~   "
130551|NCT01858532|"~     This study is being conducted to evaluate the effects of Atrasentan on Renal Outcomes in~     Subjects with Type 2 Diabetes and Nephropathy.~   "
130552|NCT01858519|"~     This is a point prevalence study conducted entirely in the United States (US) to establish~     the prevalence of antibodies to hepatitis E virus (HEV) and other selected porcine viruses in~     cystic fibrosis (CF) patients receiving pancreatic enzyme replacement therapy (PERT) for~     pancreatic insufficiency compared with matched (age and region of residence) control patients~     with chronic medical conditions unexposed to PERT.~   "
130553|NCT01858506|"~     Aim: To evaluate a culturally-adapted method of lifestyle assessment, counseling, and~     education among Arab people with diabetes who have varying literacy skills using an~     interactive computerized tool and graphically-enhanced patient logs for dietary and physical~     activity.~      The investigators hypothesize that this tool will: a) increase patients' knowledge and~     understanding of the role of lifestyle (diet and physical activity) in diabetes management;~     b) improve patients' engagement in monitoring dietary intake and physical activity; c)~     improve dietary and physical activity behaviors and self-blood glucose monitoring (SBGM)~     practices; d) improve glycemic control; and, e) improve the efficiency of lifestyle~     assessment, education and counseling while increasing patients' engagement in the process.~   "
130554|NCT01858493|"~     To determine whether women exposed to the continence promotion intervention will report~     improved urinary symptoms and quality of life, and lower incontinence-related stigma and~     falls than women who receive a control intervention at one-year post-intervention.~   "
130555|NCT01858480|"~     To evaluate the safety and to determine the efficacy of D-ribose for the treatment of~     congestive heart failure (CHF) in subjects who have been stabilized following hospitalization~     with acute decompensation.~   "
130556|NCT01858467|"~     The LMA Supreme (SLMA) is a single-use supraglottic device that provides a good seal for~     positive pressure ventilation and good first attempt insertion rate of 98% in low-risk~     patients undergoing Caesarean section. It has a double aperture design that facilitates the~     introduction of an orogastric tube to aspirate gastric contents. The current practice is to~     use endotracheal intubation with rapid sequence induction in general anaesthesia for~     Caesarean section.~      The primary study hypothesis is the first attempt insertion success rate of SLMA and~     endotracheal intubation are equivalent with a difference of less than 3%.~   "
130557|NCT01858454|"~     The aim of this study was to evaluate the feasibility and usefulness of Hand-assisted~     laparoscopic surgery (HALS) for myomectomy, and compare it with the open approach in~     myomectomy.~   "
130558|NCT01858441|"~     Prostate cancer is the 2nd leading cause of mortality in men in developed countries. For~     metastatic prostate cancer patients, the 1st-line treatment relies on hormone therapy.~     However, the efficacy of androgen deprivation therapy remains limited in time and most~     patients eventually develop castration-resistant prostate cancer (CRPC), while remaining~     androgen-dependent.~      Docetaxel is currently the standard of care for metastatic CPRC. It has been shown that~     testosterone levels within metastatic tumoral tissue from men receiving hormone therapy were~     significantly higher than those from primitive tumors of untreated prostate cancers. Among~     the mechanistic explanations for this observation, it has been shown that CYP17A1, a key~     enzyme in de novo steroid synthesis localized in testis and adrenal gland, is up-regulated in~     CRPC metastases. The existence of de novo CYP17A1-dependent androgen biosynthesis at the~     tumor level has supported the development of novel antiandrogens, including abiraterone~     acetate (AA), an irreversible CYP17A1 inhibitor. Based on a placebo-controlled phase III~     trial, demonstrating that abiraterone prolonged overall survival (14.8 vs 10.9 months) and~     increased PSA response rate (29% vs 6%) in patients with metastatic CRPC who previously~     received docetaxel, AA was recently approved by the FDA and French Health Authorities. AA is~     well-tolerated and main toxicities are urinary tract infections (2%) and a syndrome of~     secondary mineralocorticoid excess characterized by fluid overload, hypertension and~     hypokaliema (1% to 4% of grade 3-4).~      Almost concomitantly, a novel taxane-class cytotoxic agent, cabazitaxel, has proven efficacy~     in CRPC treatment after failure to docetaxel, and has recently been approved by the FDA and~     French Health Authority. Although cabazitaxel exhibits a less favorable toxicity profile,~     this precise context creates a need to dispose of objective individual criteria so as to~     orientate patients to treatment towards AA or towards cabazitaxel. To this purpose, several~     approaches are of potential interest for identifying good candidates for a treatment by AA:~     tumor-specific TMPRSS2-ERG gene fusion measurement, circulating tumor cell analysis, tumoral~     CYP17A1 expression, analysis of splicing forms of the androgen receptor. However, the~     clinical relevance of these potential predictive factors remains to be established in this~     setting.~      Pharmacogenetics examines germinal gene polymorphisms likely to influence the~     pharmacodynamics of anticancer agents. Encouraging results have recently been reported by our~     group for irinotecan pharmacogenetics with concrete possibilities of individual dose~     adaptations, and very recently by other investigators for sunitinib pharmacogenetics.~     Concerning AA, one can hypothesize that tumors with elevated CYP17A1 expression will be more~     likely to respond better to AA. This hypothesis is indirectly supported by the observation~     that in CPRC patients receiving AA, PSA-based response is higher in patients with elevated~     pre-treatment blood concentration of DHEA and androstenedione.~      The CYP17A1 gene presents numerous single nucleotide polymorphisms (SNPs), whose frequencies~     of rare alleles are at least 12%. Their functional impact has been suggested for nine of~     them, which were linked either to the risk of developing prostate cancer or to survival of~     prostate cancer patients. So far, no study has examined the links between these polymorphisms~     and the efficacy of a CYP17A1 inhibitor. Also, relationships with the efficacy of androgen~     deprivation therapy have recently been reported for SNPs of genes involved in the~     membrane-transport testosterone and dehydroepiandrosterone, namely SLCO2B1 and SLCO1B3. One~     can make the hypothesis that gene polymorphisms of these transporters may play a role for the~     intratumoral concentration of testosterone locally-produced through the mediation of CYP17A1~     activity.~      To resume, two second-line treatments of metastatic CRPC cancers are currently available,~     thus is raising the question in practice of which treatment is more appropriate for a given~     patient. Herein, the present study proposes an original pharmacogenetic approach in order to~     highlight a relationship between AA activity and patient's genetic profile. Ultimately, this~     could reveal evidences of genetic predispositions for potentially good responders to AA~     treatment.~   "
130559|NCT01858428|"~     This study is designed to evaluate the safety and efficacy of a Paclitaxel-coated~     percutaneous transluminal angioplasty (PTA) Catheter in the treatment of patients with~     peripheral arterial disease.~   "
130562|NCT01858389|"~     This is a Phase 2 study of oral dacomitinib given every 12 hours over days 1-4 of each~     two-week cycle to patients with Non-small cell lung cancer. The study includes two groups of~     patients, those whose tumor has a documented T790M mutation, and those without this mutation.~     All patients will receive repeated cycles of dacomitinib until disease progression,~     occurrence of unacceptable toxicity, or other withdrawal criteria are met.~   "
130563|NCT01858376|"~     The hypothesis of this study is that the natural supplement Capros will decrease LDL levels,~     platelet aggregation, and serum concentrations of high sensitivity C-reactive protein in~     humans at risk for cardiovascular disease.~   "
130564|NCT01858363|"~     This is a prospective, randomized, multi-center, single-blind study to demonstrate the safety~     and effectiveness of the CVI Paclitaxel-coated percutaneous transluminal angioplasty (PTA)~     balloon versus bare PTA balloon for the treatment of patients with de novo occluded/stenotic~     or reoccluded/restenotic lesions of the superficial femoral (SFA) and popliteal arteries.~   "
130565|NCT01858350|"~     The investigators conducted a prospective open unblinded clinical four-arm evaluation of~     Complementary and Alternate Medicine (CAM) interventions on children 1-12 years of age who~     were undergoing imaging by Medical Resonance Imaging(MRI) and receiving parenteral sedation.~     Children were assigned to active music therapy, passive music therapy, distraction therapy,~     and no intervention; measures included doses and numbers of sedation medications, time of~     sedation, and salivary levels of the stress hormone cortisol and pro-inflammatory cytokines,~     before and immediately after the intervention was completed. The Time Frame for the outcome~     measures are at the start of the intervention and immediately following the procedure~     (generally about 150 minutes). No further follow up was conducted.~   "
130566|NCT01858337|"~     -  Rationale: Despite the health benefits, children's consumption of vegetables is below~          the recommendations. Most human food preferences are learned through mere exposure,~          imitation, and conditioning principles. During the last years, it has become clear that~          the development of food preferences starts very early in life. Furthermore, preferences~          that are learned early in life, are relatively stable and may track into adulthood.~          However, it is unclear how vegetable preferences develop from infancy until young~          childhood. In order to influence vegetable consumption, it is essential to study the~          opportunities to develop a preference for vegetable products early in childhood.~        -  Objective: The aim of this study is to investigate the effect of repeated exposure to~          vegetables compared to repeated exposure to fruit during weaning on short and long term~          vegetable and fruit intake. Furthermore, the stability of the learned fruit or vegetable~          preferences and the later food preferences are measured (i.e. vegetable, fruits,~          sweets).~        -  Study design:~      In this longitudinal study we will measure the development of preferences for a particular~     vegetable or fruit type within 4 to 6 months old subjects, during a 19 day exposure period to~     fruit or vegetables (of which 9 days exposure to the target fruit or vegetable) and 6 months~     after this exposure period. In addition, we compare the food preferences (fruit, vegetable,~     sweet foods in general), after 6 months, between infants who were weaned with a variety of~     fruits and infants who were weaned with a variety of vegetables.~   "
130567|NCT01858324|"~     Hypertensive disorders of pregnancy happen in 5% of pregnancies. Being aware of symptoms and~     complications may help women to present early and preserve their own and their baby's health.~      The proposed research aims to evaluate the impact of educational tools in pregnant women from~     an ambulatory population. These tools include a detailed pamphlet (including a graphic-based~     summary), a magnet summarizing symptoms and appropriate action, and a video. Level of~     knowledge will be evaluated after one month with a validated questionnaire. We will also~     evaluate if getting more information about preeclampsia increases patient anxiety as well as~     satisfaction about the tools.~   "
130568|NCT01858311|"~     A natural form of vitamin E called tocotrienol (TCT) has blood thinning and cholesterol~     lowering properties, both of which may benefit stroke survivors. This study is being~     conducted to determine the blood thinning and cholesterol lowering properties of TCT in~     stroke or TIA (transient ischemic attack, which is also referred to as a mini-stroke)~     survivors that are receiving the standard treatment for prevention of recurrent stroke.~      Study Hypothesis: Oral TCT decreases the incidence of aspirin and clopidogrel nonresponders,~     increases the extent of inhibition of platelet aggregation, and decreases LDL without~     significant side effects in stroke patients.~   "
130569|NCT01858298|"~     The purpose of this study is to compare the effectiveness of the conservative (pulpectomy)~     versus non-conservative treatment (tooth extraction) of primary molars affected with severe~     dental caries associated to oral health-related quality of life, anthropometric and clinical~     outcomes.~   "
130570|NCT01858285|"~     Investigators at Boston Children's Hospital are conducting research in order to better~     understand the genetic factors which may contribute to disorders related to epilepsy. These~     findings may help explain the broad spectrum of clinical characteristics and outcomes seen in~     people with epilepsy.~   "
130571|NCT01858272|"~     The primary objectives of this study are to evaluate the efficacy, dosing, and safety of an~     intra-ulcer injection H5.020CMV.PDGF-b in adults who have a venous leg ulcer. The primary~     endpoint of this Phase I trial is the determination of the Maximum Tolerated Dose (MTD) for~     the intra-ulcer injection of H5.020CMV.PDGF-b.~   "
130572|NCT01858259|"~     Systemic sclerosis (SSc) is an orphan, multiorgan disease affecting the connective tissue of~     the skin and all internal organs. Interstitial lung disease is a frequent morbidity and~     mortality-driving manifestation in systemic sclerosis.~      This observational trial (OT) is part of the collaborative project DeSScipher, one out of~     five OTs to decipher the optimal management of systemic sclerosis. Aim of this observational~     try is to identify:~        -  The state of clinical practice in Europe for prevention and treatment of interstitial~          lung disease and its impact on lung function and disease progression~        -  The potential predictors and confounders for response to therapy~   "
130573|NCT01858246|"~     The Bonebridge is a new bone conducting implantable hearing aid. The investigators plan to~     randomize patients to receive either the Bonebridge or a conventional bone conducting hearing~     device. The investigators will then compare the surgical and audiological outcomes of the two~     groups.~   "
132741|NCT01829828|"~     The purpose of this survey is to investigate the usefulness of a patient self-reported~     scoring tool on patient satisfaction improvement.~   "
130574|NCT01858233|"~     The IBEP study is a randomized control trial of a healthy lifestyle intervention program for~     women with gestational diabetes. The primary aim of the study is to evaluate whether women~     with gestational diabetes enrolled in an intensive behavioral educational program (IBEP)~     demonstrate lower mean fasting glucose levels measured by 2 hour 75 gram oral glucose~     tolerance test (OGTT) at 6 weeks postpartum compared to women with gestational diabetes who~     undergo routine gestational diabetes education and counseling.~   "
130575|NCT01858220|"~     Gastroparesis is a syndrome characterized by delayed gastric emptying in absence of~     mechanical obstruction of the stomach. The cardinal symptoms include postprandial fullness~     (early satiety), nausea, vomiting, and bloating.Capsule endoscopy (CE) has evolved to become~     a first-line, noninvasive diagnostic technique for the small bowel. CE is now being utilized~     to assess patients for obscure gastrointestinal bleeding, possible Crohn's disease, celiac~     disease and small bowel tumors. Capsule endoscopy is preformed in a fasting state, and~     usually past the pylorus of the stomach into the duodenum after up to 30-40 minutes. The aim~     of the study is to determine the correlation between gasytoparesis symptoms to duration of~     capsule retention in the stomach~   "
130576|NCT01858207|"~     Abstract of Research Proposal Radiofrequency ablation (RFA) has been proved to be a curative~     treatment with minimal invasiveness and high efficacy for small hepatocellular carcinoma~     (HCC) that is generally defined as maximal diameter no larger than 3cm. RFA can achieve a~     rate of complete necrosis as 80-100% in small HCC. However, the rate will drop to 71% in HCC~     of 3.1-5cm and 25% for HCC larger than 5cm。This is due to the relative hypervascularity for~     the bigger tumor and it will induce heat sink that leading to less effect of ablation.~     Therefore, transcatheter chemoembolization (TACE) before RFA may reduce the vascularity and~     enhance the effect of subsequent RFA. Moreover, pre-RF TACE will reduce the tumor size and~     the subsequent RFA will be more effective than RFA alone. In retrospective studies, Kitamoto~     M et al showed that tumor necrosis diameter was larger in TACE and RFA combination therapies~     compared to RFA mono-therapy; Yamakado K et al showed that TACE and RFA combination therapies~     in HCC (maximal diameter up to 12 cm) achieved 100% complete necrosis, 0% local recurrence~     rate and 93% of 2-year survival rate. Nevertheless, only one randomized trial in intermediate~     size HCC (3-5cm in diameter) showed that TACE and RFA combination therapies achieved a~     significant higher rate of complete necrosis, technique success, fewer treatment sessions to~     achieve complete necrosis and lower local recurrence but non-significant difference in 3-year~     survival rate. Therefore, based on the limited studies, combine TACE and RFA may achieve~     better effects than RFA mono-therapy in HCC larger than 3cm. However, repeat TACE may induce~     some complications such as HBV reactivation, hepatitis or even liver decompensation.~     Moreover, novel RFA using simultaneous multiple RFA probes with switching RF controller may~     achieve a better effects and shorter ablation time than sequential RFA with single electrode.~     Thus, is it still necessary using TACE and RFA combination therapies for HCC >3cm when~     application of novel switching RF controller? The aim of the current study is to conduct a~     RCT comparing combine TACE and RFA compared to RFA mono-therapy by using simultaneous~     multiple electrodes and switching RF controller in uni-lobar HCC of 3.1-7cm. The rate of~     complete necrosis, technique success, sessions to achieve CN, local tumor progression,~     survival rate and major complications will be analyzed. Investigators cannot expect which one~     is better, safer before the achievement of the study.~   "
130577|NCT01858194|"~     Despite significant advances in the management of ventricular arrhythmias through the use of~     ICD therapy, AADs, and catheter-based ablation strategies, considerable challenges remain.~     The optimal method for the prevention of recurrent VT following catheter ablation remains~     unclear. RSDN may be an effective tool for preventing ventricular arrhythmias, and associated~     ICD therapies, by reducing central sympathetic tone, catecholamine levels, and the~     renin-angiotensin- aldosterone system and promoting ventricular remodeling. Although RSDN has~     been shown to reduce the recurrence of VT in a case report of 2 patients suffering from~     electrical storm, to date no large prospective randomized study has evaluated the impact of~     RSDN in the prevention of recurrent VT in patients following catheter ablation of VT with~     ischemic or non-ischemic ventricular dysfunction. This study will specifically evaluate the~     safety and efficacy of adjunctive RSDN in the prevention of ICD therapy in patients with~     ischemic or non-ischemic ventricular dysfunction who are to receive a catheter-based VT~     ablation.~   "
130578|NCT01858181|"~     Ocaratuzumab is a third-generation, fully humanized IgG1 monoclonal antibody (mAb) targeting~     the CD20 surface marker on normal and malignant B lymphocytes. It has been optimized for an~     increased binding for CD20 and an enhanced antibody dependent cell medicated cytotoxicity~     (ADCC) effector function.~      A previous phase I/II study of intravenously (IV) administered ocaratuzumab in~     refractory/relapsed follicular lymphoma patients has concluded that ocaratuzumab is safe and~     well-tolerated at doses up to 375mg/ m2 weekly for four weeks.~      In this proposed phase I study, ocaratuzumab will be administered subcutaneously to patients~     with previously treated CD20+ B-cell malignancies. Three dose levels (40 mg weekly x 4 doses,~     80 mg weekly x 4 doses, and 80 mg weekly x 8 doses) will be investigated for safety,~     tolerability, pharmacokinetic, and pharmacodynamic analyses.~   "
130579|NCT01858168|"~     This research study is a Two arm Phase I clinical trial, which tests the safety of an~     investigational drug or combination of drugs and also tries to define the appropriate dose of~     the combination of investigational drugs to use for further studies. Investigational means~     that the combination of drugs is being studied. It also means that the FDA has not yet~     approved the combination of drugs for your type of cancer.~      Olaparib works by blocking the activity of a protein called poly (ADP-ribose) polymerase~     (PARP) which is involved in DNA repair. Cancer cells rely on PARP to repair their DNA and~     enable them to continue dividing. Olaparib has been used in research studies with other~     cancers. Information from those other research studies suggests that this drug may help to~     treat patients with Ewing's sarcoma. The investigational drug olaparib is not approved for~     any use outside of research studies.~      Temozolomide (Temodar) is approved by the FDA for the treatment of a type of brain tumor,~     glioblastoma. It has been studied in Ewing sarcoma in previous research studies. While it is~     not approved by the FDA for Ewing sarcoma, it is considered part of standard treatment for~     relapsed disease.~      Irinotecan is approved by the FDA for the treatment of gastrointestinal cancers. It has been~     studied in Ewing sarcoma in previous research studies. While it is not approved by the FDA~     for Ewing sarcoma, it is considered part of standard treatment for relapsed disease.~      Laboratory studies suggest that the combination of olaparib and temozolomide and irinotecan~     may help kill Ewing sarcoma cells.~      In this research study, the investigators are looking for the highest dose of the combination~     of olaparib and irinotecan and/or temozolomide that can be given safely. The investigators~     will also begin to collect information about the effects of the combination on Ewing sarcoma.~   "
130580|NCT01858155|"~     This study will evaluate dose escalation of melatonin in pediatric oncology patients with~     relapsed solid tumors. The purpose of this study is to determine the safety of melatonin at a~     dose up to 20 mg daily, as well as to determine the maximum tolerated dose of melatonin.~   "
130581|NCT01858142|"~     Children are distressed at anesthesia induction and this distress can result in maladaptive~     recovery outcomes. Having parents be present at anesthesia induction (PPIA) has been~     suggested as a potential intervention to decrease children's distress, and this intervention~     is widely favored by parents. However, to date, PPIA has not been found to be effective in~     reducing children's anxiety. The lack of efficacy may be attributable to the fact that~     parents have generally not been prepared for PPIA. The one study that prepared parents (as~     part of a larger preoperative preparation program) found that PPIA with preparation was~     superior to PPIA as previously studied (without preparation). Unfortunately, this program is~     resource intensive and therefore is not clinically feasible. This study will compare PPIA~     with a clinically feasible preparation program to PPIA with standard care (minimal~     preparation). Should our intervention show evidence of efficacy, the investigators will have~     designed a program that is easily translatable to everyday clinical practice. This will, in~     turn, reduce children's anxiety, improve postoperative outcomes and increase parental~     satisfaction.~   "
130582|NCT01858129|"~     Transient Tachypnea of the Newborn (TTN) is a common respiratory disorder affecting late~     preterm and term babies caused by lung edema resulting from delayed absorption of fetal~     alveolar lung fluid.~      The investigators hypothesize that ENAC expression will be up-regulated as a result of~     administration of corticosteroids. This effect will lead to enhanced absorption of fetal lung~     fluid finally treating TTN. The aim of our study will be to evaluate whether inhaled~     corticosteroids reduce respiratory distress and morbidity in late preterm and term neonates~     presenting with TTN.~   "
130583|NCT01858116|"~     The study will evaluate [68Ga]ABY-025 for PET imaging of HER2 expression in subjects with~     HER2-positive or HER2-negative breast cancer.~   "
130584|NCT01858103|"~     The Expanded Access Program (EAP) is an open-label, multicenter program to:~        1. Provide patients who have been diagnosed with Mucopolysaccharidosis IVA (MPS IVA) access~          to BMN 110 until commercial product is available~        2. Collect additional information on the safety and tolerability of BMN 110 administration~          in patients with MPS IVA~      Patients enrolled in the EAP will receive 2.0 mg/kg intravenous infusions of BMN 110 every~     week during the program.~   "
130585|NCT01858090|"~     In this prospective, randomized, double-blind, controlled study, the aim was to compare the~     effect of adding fentanyl (10 µg) or sufentanil (2.5 µg) to levobupivacaine (2.2±0.2 ml 0.5%)~     on the intraoperative anesthesia quality, block characteristics, the side effects on the~     newborn and mother, the duration of postoperative analgesia, and surgeon satisfaction score.~   "
130586|NCT01858077|"~     To evaluate the efficacy and performance in an all-comers contemporary population of the~     ABSORB bioresorbable vascular scaffolds (BVS) strategy versus the XIENCE family (XIENCE PRIME~     or XIENCE Xpedition) everolimus eluting coronary stent system in the treatment of coronary~     lesions.~   "
130587|NCT01858064|"~     The primary aim of this study is to assess the predictability of treatment response to~     stimulants in adults with ADHD using functional magnetic resonance~      This study will be a six-week, open-label study including adults ranging from age 18-55 with~     ADHD.~   "
130588|NCT01858051|"~     In the United States, ~1 million elective hip or knee replacement surgeries are performed~     annually. With estimated surgical site infection (SSI) rates as high as 2.5%, this represents~     ~25,000 patients at risk of potentially avoidable morbidity following lower extremity joint~     replacement surgery. Although SSIs only account for 20% of all HAIs, they are a major risk~     factor for prosthetic joint infections (PJIs). Furthermore, UTIs have also been identified as~     an independent risk factor for infections of implanted hardware.~      In general, the majority of PJIs become apparent within 3 months of hardware implantation,~     but deep infections may not be evident for up to one year after surgery. Hardware infections~     result in delayed healing, repeated surgical interventions, and long-term antibiotic therapy.~     PJIs are associated with an average increase in hospital LOS by 14 days, additional~     expenditures of up to $50,000 per infected joint, and a doubling of the mortality rate~     compared to uninfected lower extremity joint replacements.~      Recent work from our group suggests that vitamin D insufficiency may be a risk factor for~     perioperative HAIs. The prevalence of vitamin D insufficiency is approximately 40% in~     elective joint replacement surgery patients, and perioperative 25(OH)D levels drop 30-40% in~     the setting of surgical stress, remaining 20% below baseline up to 3 months after surgery. To~     date, perioperative vitamin D optimization strategies have not been reported. Therefore, our~     goal is to study the effect of a single (pre-operative) versus a divided (pre-operative and~     on post-operative day 1) dose of cholecalciferol on perioperative vitamin D status in~     patients scheduled for elective hip or knee joint replacement surgery.~   "
130589|NCT01858038|"~     This project aims to understand the molecular biology underlying the improvement of surgical~     scars treated by ablative fractional photothermolysis (FP). Previous human studies at MGH~     have shown that FP significantly improves the appearance and functionality of surgical and~     burn scars. At the Wellman Center, we have conducted a randomized, controlled study on linear~     surgical scars demonstrating the efficacy of FP to decrease the volume of hypertrophic scars,~     and to improve the appearance and texture of scars. However, the underlying mechanism of this~     therapeutic effect is unknown. It is clear that FP induces wound healing and remodeling of~     the normal skin surrounding microthermal zones (MTZs). Furthermore, other researchers have~     employed animal models using transgenic zebrafish and the mouse eye, and found that laser~     treatments induce changes in gene expression in specific cells. We propose to determine~     whether the effect of FP on scar improvement occurs via changes in patterns of local gene~     expression within the skin, specifically dermal fibroblasts. By characterizing these changes,~     we may be able to identify molecular mechanisms that both explain and contribute to the~     beneficial effects of FP in the surgical and traumatic scar. The molecular insights into the~     therapeutic effects of fractional laser photothermolysis may provide a basis for future~     therapeutic strategies to improve scar remodeling.~   "
130590|NCT01858025|"~     This research study is a Pilot Study. Pilot studies are conducted to see if it is practical~     to do this type of research ona larger scale in the future. The pilot part of the study is to~     assess the possibility of using pencil beam proton radiation to treat your type of cancer.~     Proton radiation is used for many other types of malignancies, but its use for the treatment~     of anal cancer has been limited. The treatment is still being studied as research doctors are~     trying to find out more about its use in the treatment of anal cancer. Proton beam radiation~     therapy is an FDA approved radiation delivery system.~      You are being asked to participate in this study because you have cancer in the anal canal.~     Conventional radiation therapy with photons in combination with 5-FU and mitomycin-C is used~     as standard treatment for many patients with anal cancer.~      In this research study we are looking at another type of radiation called proton radiation,~     which is known to spare surrounding tissue and organs from radiation. Proton radiation~     delivers radiation to the area requiring radiation but delivers no dose beyond the region~     requiring treatment. There are several techniques that can be used to deliver proton~     radiation therapy. One of the newer techniques, called pencil beam scanning, allows for more~     accurate delivery of radiation to your tumor and further reduces the amount of normal tissue~     exposed to radiation. Most proton patients are treated with a number of beams that study~     doctors conform to the shape of your tumor. Pencil beam scanning delivers radiation with a~     single, narrow proton beam that is swept over the area of your tumor. This may reduce side~     effects that patients would normally experience with conventional radiation therapy or other~     means of delivering proton radiation therapy, and also minimizes treatment time.~      In this research study, we are evaluating the effectiveness of using pencil beam proton~     radiation delivered to reduce side effects associated with radiation treatment.~   "
130591|NCT01858012|"~     The study hypothesis is that the means by which HCV induces glucose intolerance is through~     impairment of B-cell function and compensatory hyperinsulinemia in predisposed Latinos with~     insulin resistance and that HCV eradication improves these abnormalities. It is also~     hypothesized that moderate alcohol consumption impact insulin sensitivity and secretion with~     Latinos with or without HCV infection.~   "
141828|NCT01710865|"~     The purpose of this study is to assess the effectiveness of a new hydrophilic sealant~     (Ultraseal XT Hydro) compared to the previously existing hydrophobic sealant materials~     (Ultraseal XT Plus) which requires prime and dry to dry the tooth surface.~   "
130592|NCT01857999|"~     The dual blockade of the renin-angiotensin-aldosterone system with an angiotensin-converting~     enzyme inhibitor and an angiotensin-receptor blocker used together in heart failure patients~     has been demonstrated to be beneficial. However, the dual inhibition has not been studied~     during heart failure decompensation or even when low cardiac output is present.~      The objective of this study was to assess the effects of add-on therapy with angiotensin~     receptor blocker on plasma B-type natriuretic peptide levels and hemodynamic measurements in~     heart failure patients with low cardiac output during hospitalization for decompensation.~      This was a randomized, double-blind, placebo-controlled clinical trial.~   "
130593|NCT01857986|"~     This trial is designed to assess the effectiveness of the AnapnoGaurd 100 system relative to~     standard of care (SOC) Control, in the course of mechanical ventilation and intubation. The~     main effectiveness aspect of this trial is the AnapnoGaurd 100's ability to reduce leaks~     between the endotracheal tube and the trachea walls as a result of the cuff pressure~     management. Since the primary outcome can't be measured by any method other than the~     investigational device, the study groups will be treated as follows:~        -  The Treatment group in this study will be treated with the fully functional AnapnoGaurd~          100 device (per its intended use),~        -  The Control group will be treated with the AnapnoGuard device, where the cuff control~          will be disabled (off) and the cuff management will be done according to SOC.~      Effectiveness will be measured by the duration and level of carbon dioxide (CO2) leakage~     around the endotracheal tube (ETT) cuff, from the lungs to the subglottic space and safety~     will be measured by adverse events (AEs).~   "
130594|NCT01857973|"~     This is a multicenter feasibility study. Up to 85 subjects will be enrolled in the study. The~     goal of the study is to demonstrate that the Hybrid Closed Loop (HCL) System is safe to be~     used in an even larger study outside of hospital.~   "
130595|NCT01857960|"~     Acne is a chronic inflammatory disease that affects almost 100% of the teenagers worldwide.~     The peak incidence is between 12 and 18 years old, although it can be present in adults.~     There are many different beliefs about what can cause or exacerbate acne, and also about~     treatment.~      In Mexico, 26.4% of the population is between 15 and 29 years old, which represents that more~     than 25% of the population is at risk for presenting acne. In our country, the different~     beliefs about the causes and treatment of acne among general adolescent population have not~     been explored. The objective of the present study is to determine the possible causes for~     which young Mexicans do not go to the dermatologist to receive treatment for acne. Our main~     hypothesis is that the lack of knowledge of the disease is responsible for this behavior.~   "
130596|NCT01857947|"~     The purpose of this study is to determine whether pro-adrenomedullin (Mr proADM)in addition~     to clinical evaluation is effective to predict outcome of acute exacerbations of COPD~     patients visiting the emergency room(ER).~   "
130597|NCT01857934|"~     Neuroblastoma is the most common extracranial solid tumor in childhood, with nearly 50% of~     patients presenting with widespread metastatic disease. The current treatment for this group~     of high-risk patients includes intensive multi-agent chemotherapy (induction) followed by~     myeloablative therapy with stem-cell rescue (consolidation) and then treatment of minimal~     residual disease (MRD) with isotretinoin. Recently a new standard of care was established by~     enhancing the treatment of MRD with the addition of a monoclonal antibody (ch14.18) which~     targets a tumor-associated antigen, the disialoganglioside GD2, which is uniformly expressed~     by neuroblasts. Despite improvement in 2-year event-free survival (EFS) of 20%, more than~     one-third of children with high-risk neuroblastoma (HR defined in) still cannot be cured by~     this approach. Therefore, novel therapeutic approaches are needed for this subset of~     patients. This study will be a pilot Phase II study of a unique anti-disialoganglioside~     (anti-GD2) monoclonal antibody (mAb) called hu14.18K322A, given with induction chemotherapy.~      PRIMARY OBJECTIVE:~        -  To study the efficacy [response: complete remission + partial remission (CR+PR)] to two~          initial courses of cyclophosphamide and topotecan combined with hu14.18K322A (4~          doses/course followed by GM-CSF) in previously untreated children with high-risk~          neuroblastoma.~        -  To estimate the event-free survival of patients with newly diagnosed high-risk~          neuroblastoma treated with the addition of hu14.18K322A to treatment.~      SECONDARY OBJECTIVES:~        -  To study the feasibility of delivering hu14.18K322A to 6 cycles induction chemotherapy~          and describe the antitumor activity (CR+PR) of this 6 course induction therapy.~        -  To estimate local control and pattern of failure associated with focal intensity~          modulated or proton beam radiation therapy dose delivery in high-risk abdominal~          neuroblastoma.~        -  To describe the tolerability of four doses of hu14.18K322A with allogeneic natural~          killer (NK) cells from an acceptable parent, in the immediate post-transplant period~          [day +2 - +5 after peripheral blood stem cell (PBSC) infusion] in consenting~          participants.~        -  To describe the tolerability of hu14.18K322A with interleukin-2 and GM-CSF as treatment~          for minimal residual disease (MRD).~   "
130598|NCT01857921|"~     Trimetazidine is a metabolic agent without any negative inotropic or vasodilatory properties.~     In addition, previous reports showed that trimetazidine was effective in reducing~     intracoronary platelet aggregation and preventing platelet thrombogenesis. Therefore, for the~     evaluation of these combination effects of statin and trimetazidine on patients with aspirin~     monotherapy who had previously received CABG and were free of the major adverse cardiac~     events such as death, MI, TLR, or TVR for 12 months, the investigators hypothesize that~     atorvastatin 40mg/day would be more effective in the prevention of the further late adverse~     cardiac and cerebrovascular events than other statin. To test this hypothesis, the~     investigators will perform a multi-center, randomized, prospective trial aimed at~     demonstrating the superiority of combination of high dose atorvastatin therapy and~     trimetazidine to pravastatin in patients with aspirin monotherapy 12 months after CABG~     surgery in real world practice.~   "
130599|NCT01857908|"~     Adrenal androgens are serum biomarkers of interest that may help guide abiraterone acetate~     treatment, particularly at the time of progression. Biomarkers may also help identify~     pathways to resistance of abiraterone acetate treatment. The most practical way of~     approaching this question is to explore surrogate biomarkers of prostate cancer including~     quantification of pharmacodynamic endocrine biomarkers.~   "
130600|NCT01857895|"~     This is an open-label study to investigate the feasibility of administering exenatide by~     continuous subcutaneous infusion to healthy subjects. Study will consist of two parts i.e.~     Part A and B. In Part A 2 healthy subjects will receive exenatide infusion over 24 hours~     followed by a follow-up visit 10 to 14 days after discharge from clinic. In Part B~     approximately 6 healthy subjects will receive subcutaneous infusions of exenatide for maximum~     of 7 days followed by a follow-up visit 10 to 14 days after discharge from clinic.~   "
130601|NCT01857882|"~     The purpose of this study is to determine the effectiveness of a pre-consultation decision~     support workshop for breast reconstruction after breast cancer, in facilitating the~     decision-making process, compared to routine pre-surgical education.~   "
132758|NCT01829607|"~     The purpose of this study is to evaluate the effects of functional electrical stimulation of~     peripheral muscles on clinical and emotional status, endothelial function and left~     ventricular diastolic function in heart failure with preserved left ventricular ejection~     fraction.~   "
130602|NCT01857869|"~     This study is designed to evaluate safety, reactogenicity, immunogenicity, and efficacy of~     GSK Biological's malaria candidate vaccine 257049 administered as standard doses at 0 and 1~     months and 1/5th standard dose at 7 months (delayed fractional dose group) and 257049~     administered as three standard doses one month apart (0, 1, 2-month group) in healthy~     malaria-naïve volunteers aged 18-50 years in the sporozoite challenge model.~      An additional, delayed sporozoite challenge will assess persistence of protection induced by~     the primary immune schedule and if an additional dose can provide protection in those~     unprotected by the initial vaccination series.~   "
130603|NCT01857856|"~     Phospholamban (PLN) R14del mutation carriers may develop dilated cardiomyopathy (DCM) and/or~     arrhythmmogenic cardiomyopathy (ACM). Analogous to other inherited cardiomyopathies, the~     natural course of the disease is age-related (age-related penetrance); after a~     presymptomatic phase of variable length many PLN R14del-carriers progress to overt disease,~     and are diagnosed with either DCM or ARVC. PLN is a regulator of the sarcoplasmic reticulum~     Ca2+-ATPase (SERCA2a) pump in cardiac muscle and thereby important for maintaining Ca2+~     homeostasis. Cardiac fibrosis appears to be an early manifestation of disease. The~     investigators hypothesize that treatment of presymptomatic PLN R14del-carriers with~     eplerenone, which by virtue of its mineralocorticoid(aldosterone)-blocking properties is a~     strong antifibrotic agent, reduces disease progression and postpones onset of overt disease.~   "
130604|NCT01857843|"~     Objective: To evaluate the early effects of intensive lipid lowering treatments with~     ezetimibe/simvastatin (Vytorin®) for each component of coronary plaques.~      Study Design~        -  Prospective, randomized, single-center study of each 80 subjects enrolled~        -  Subjects with acute coronary syndrome who meet all inclusion and exclusion criteria will~          be enrolled.~        -  Eligible subjects will be randomized 1:1 to A) Ezetimibe/Simvastatin (n=80) vs. B)~          Pravastatin (n=80), and each group of patients will be randomized further in a ratio of~          1:1 to a) ZES (n=40) vs. b) EES (n=40), according to the type of stent used.~        -  All subjects will undergo VH-IVUS at initial procedure.~        -  Follow-up VH-IVUS will be performed at 3 months after index procedure. OCT at initial~          procedure and 3-months will be performed in available cases.~   "
130605|NCT01857830|"~     The purpose of this research study is to examine whether a short term meditation intervention~     can improve health, mood, and biological markers of cellular stress and aging in novice and~     experienced meditators compared to controls.~   "
130606|NCT01857817|"~     The purpose of this study is to evaluate the clinical benefit of the co-administration of~     propranolol and etodolac (VT-122 therapy) in patients with clinically progressive prostate~     cancer.~   "
130607|NCT01857804|"~     The objective of this randomized controlled clinical trial is to evaluate the outcome of~     treatment of peri-implantitis with or without systemic antibiotics.~      Specific aims are to analyze (i) the effect of systemic antibiotics and local antiseptics on~     the healing process, and (ii) the risk for recurrence of disease following surgical treatment~     of peri-implantitis.~   "
130608|NCT01857791|"~     Childhood obesity has more than tripled in the past 30 years. From 1980 to 2008, the~     prevalence of obesity among adolescents aged 12 to 18 years, increased from 5.0% to 18.1%.1~     Although several pediatric weight management programs are available, access to these programs~     may not always be possible.~      The proposed study will be an ongoing research program with approximately 40 children ages~     12-18 years enrolled into the study over a year. All study participants will participate in a~     baseline evaluation which will include body composition measures, aerobic testing, as well as~     nutrition and physical activity questionnaires. Study participants will be assigned to the~     clinic-based group. The clinic- based group will participate in a 12-week multi-disciplinary~     weight management program. All study participants will then participate in a 12-week~     follow-up evaluation similar to the baseline visit. New participants will be enrolled every~     12 weeks. Every 12 weeks, active participants (those that have completed a minimum of 12~     weeks) will have the option to continue in the program or, discontinue their active~     participation in the program and enroll into the maintenance phase which will consist of~     measures only every 12 weeks.~      The objective of the proposed study includes examining the efficacy of the clinic-based,~     multi-disciplinary, pediatric weight management program.~   "
130609|NCT01857778|"~     There will be breast tissue changes after use of a breast pump.~   "
130610|NCT01857765|"~     The purpose of this study is to determine whether implementing a rehabilitation program can~     improve the post-operative time to pain free living after breast augmentation.~   "
130611|NCT01857752|"~     Primary Objectives:~        1. To investigate the response rate (complete response plus partial response) of~          temozolomide for 8 weeks (2 cycles), in patients with retinoblastoma metastatic to the~          central nervous system (mass only) in two strata:~             -  A. Initial diagnosis (mass)~             -  B. At relapse (mass)~        2. To determine hematologic toxicity: absolute neutrophil count (ANC), platelets and~          hemoglobin count.~      Secondary Objectives:~        1. To determine the response in other metastatic sites (non target) (orbit, bone marrow,~          bone, lung, liver and others)~        2. To determine the remission rate and time to relapse on temozolomide.~        3. To document the response of leptomeningeal metastasis (cerebrospinal fluid) to~          temozolomide~   "
130612|NCT01857726|"~     The aim of this study is to compare the efficacy of transarterial chemoembolization with~     adriamycin to transarterial chemoembolization with adriamycin/transarterial chemoinfusion~     with cisplatin combination in advanced hepatocellular carcinoma with portal vein invasion.~   "
130613|NCT01857713|"~     The purpose of the study is to determine the safety and effectiveness of non-invasive Reza~     Band UES Assist Device for the treatment of esophagopharyngeal reflux with extra-esophageal~     symptoms (chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat,~     throat clearing).~   "
130614|NCT01857700|"~     Research questions: What effect does provision of food vouchers have on uptake of voluntary~     medical male circumcision? What is the amount of food voucher that should be given?~      Hypothesis: The percentage of men who are compensated for costs of travel to and lost wages~     due to VMMC and who undergo VMMC will be higher than the percentage of men who are~     compensated for lost wages or travel and undergo VMMC, and both of these percentages will be~     higher than the percentage of men who are not compensated for travel or lost wage costs but~     undergo VMMC.~   "
130616|NCT01857674|"~     -  For patient in intensive care unit, extubation failure is defined as the necessity of~          early reintubation after scheduled extubation, with Increased morbidity and mortality,~          so it seems important to quickly identify patients with high risk of post-extubation~          acute respiratory failure.~        -  Major post-extubation laryngeal edema is one of extubation failure causes, and its~          incidence vary in literature from 4 to 37%.~        -  We can't currently predict arising of a major post-extubation laryngeal edema. However,~          a recent pilot study showed that laryngeal ultrasonography could help to identify~          patients with high risk of post-extubation stridor, measuring ultrasonic leak volume and~          cuff-deflated air-column width, of which we propose to assess diagnostic performance.~   "
130617|NCT01857661|"~     The University of Sao Paulo Department of Otorhinolaryngology developed prototypes for a~     digital new hearing aid with an integrated sound generator. These prototypes assist both~     hearing rehabilitation (about 10% of the population) and tinnitus sufferers (about 17% of the~     population).~      Currently, the Brazilian Public Heath Care does not have any such hearing aids. So, the~     development of devices for the hearing rehabilitation as well as the treatment of tinnitus~     represents an advance in the implementation of Public Policies in Brazil.~      The aim of this study is to compare the efficacy of the hearing aid with an integrated sound~     generator and amplification alone for tinnitus control in patients with tinnitus associated~     hearing loss.~   "
130618|NCT01857648|"~     The aim of this study is to test a methodology of counseling on physical activity among~     Community Health Workers working within primary health care in Brazil.~   "
130619|NCT01857635|"~     In patients suffering from hypercapnic respiratory failure and treated by non invasive~     ventilation (NIV), the interest of using transcutaneous CO2 measurement to evaluate PaCO2 and~     PaCO2 variation over time is unknown and will be evaluated in this study. Measurements will~     be done during one-hour NIV treatments.~   "
130620|NCT01857622|"~     To assess the safety and pharmacokinetics of DU-176b administered to non-valvular atrial~     fibrillation patients with severe renal impairment, compared with DU-176b administered to~     non-valvular atrial fibrillation (NVAF) patients with normal renal function or mild renal~     impairment (Normal/MiRI).~   "
130621|NCT01857609|"~     This study aims to investigate the effect of proton pump inhibitor on the pharmacokinetics~     and pharmacodynamics of metformin in healthy Korean men.~   "
130622|NCT01857596|"~     The purpose of this study is to investigate whether Lorexys is effective and safe to treat~     premenopausal women who have lost their sexual desire to a distressing degree.~   "
130623|NCT01857583|"~     To assess the safety and pharmacokinetics of DU-176b administered to patients with severe~     renal impairment undergoing orthopedic surgery of the lower limbs, compared with DU-176b~     administered to patients with mild renal impairment (MiRI) undergoing orthopedic surgery of~     the lower limbs.~      For reference, the safety of DU-176b in patients with SRI undergoing orthopedic surgery of~     the lower limbs will be compared with that of fondaparinux.~   "
130624|NCT01857570|"~     The purpose of this study is to evaluate whether standard volume computed tomography (CT) has~     impact on treatment in patients with suspicion of fractures of the wrist and carpus.~   "
130625|NCT01857557|"~     This trial assesses the impact of a supervised aerobic exercise program by a kinesiologist in~     patients with migraine. Patients can be assigned to one of two groups 1)The exercise group or~     2)non-exercise group. This is a important area to study because there is currently limited~     information regarding exercise and its impact on migraine frequency and severity. In many~     cases, migraine patients are disabled by their headaches and sometimes will not have a~     significant response to medications. As a result, it is important to study other~     non-pharmacological interventions. In this study, the investigators hope to show the benefits~     of exercise by a reduction in number of headache days per month as well as by improvement in~     quality of life, disability,depression,anxiety,and aerobic fitness.This study will not~     interfere with the usual treatment patients receive at our headache clinic and patients can~     remain on medications deemed necessary.~   "
130626|NCT01857544|"~     The purpose of this study is determine the number of patients with complete resolution of~     macular edema secondary to central retinal vein occlusion following 6 monthly injections of~     Aflibercept.~   "
130627|NCT01857531|"~     The purpose of this research study is to evaluate whether the investigational drug ganaxolone~     can help smokers quit smoking. Ganaxolone is a drug that has been investigated (in other~     research studies) for the treatment of seizures and migraines. This drug is considered~     investigational in the US.~   "
130628|NCT01857518|"~     Adolescence is a critical period for the development of depressive disorders. As adolescence~     also is a critical period for brain maturation, it may be hypothesized that maturation~     changes in emotional circuits could underlie vulnerability for depression.~      The aims of the study are (1) to identify the changes in brain morphometry, white matter~     microstructure, and functioning, in networks associated with depression features in~     adolescents, and (2) to assess the effects of treated pathology on brain structure by~     comparing the neuroimaging measures obtained in adolescents at inclusion with those at~     follow-up.~   "
130629|NCT01857505|"~     The investigators propose to evaluate and compare the percentage of patients who are able to~     be discharged in less than 3 days after undergoing total hip arthroscopy through either a~     direct anterior or posterior approach, utilizing the identical post operative protocol. The~     investigators also propose to evaluate the costs associated with the two different approaches~     to hip replacement in the same group of patients. Post operative resource utilization,~     discharge disposition, and pain medicine requirement will also be evaluated.~   "
130630|NCT01857492|"~     This study is testing whether the addition of a noninvasive form of brain stimulation called~     transcranial direct current stimulation (tDCS) when combined with meditation helps decrease~     the abdominal pain in patients with chronic pancreatitis. The device involved in this study,~     transcranial direct current stimulation (tDCS) is investigational. This means that the study~     device is still being tested in research studies and is not approved by the Food and Drug~     Administration [FDA].~   "
130631|NCT01857479|"~     Inhaled amphotericin, a antifungal drug would decrease Aspergillus colonization and decrease~     the occurrence of exacerbations of Allergic Bronchopulmonary Aspergillosis (ABPA).~   "
141829|NCT01710852|"~     The purpose of this study is to evaluate whether treatment with ISIS CRP Rx can reduce AF~     (Atrial Fibrillation) burden (percentage of time spent in AF) in subjects with paroxysmal AF~   "
130632|NCT01857466|"~     Laparoscopy has become the gold standard for the surgical treatment of benign ovarian cysts~     and is usually performed by stripping the ovarian cyst wall, followed by bleeding control of~     the ovarian wound ground using bipolar coagulation. However, the hemostasis with bipolar~     coagulation could result in the damage of ovarian reserve and decrease the response of the~     ovaries to hormonal stimulation for assisted reproductive technologies. The possible~     mechanism may contribute to thermal destruction of ovarian follicles by excessive use of~     bipolar coagulation for hemostasis purposes.~      To avoid additional ovarian tissue damage by conventional bipolar coagulation being~     potentially important ovarian reproductive function, hemostasis using various topical~     hemostatic agents has introduced to control post-cystectomy ovarian wound bleeding. Among~     them, FloSeal (Baxter Healthcare Corporation, Deerfield, IL, USA) is a hemostatic matrix~     sealant composed of a gelatin-based matrix and thrombin solution. On coming into contact with~     blood after application at a bleeding site, the gelatin particles swell and tamponade~     bleeding. The bulk of the gelatin matrix-thrombin composite has the effect of slowing blood~     flow and providing exposure to a high thrombin concentration, thus hastening clot formation.~     Therefore, it may more suitable for use in post-cystectomy ovarian wound bleeding, where~     there is superficially pervasive focus of bleeding.~      Ovarian reserve is defined as the functional potential of the ovary, which reflects the~     number and quality of antral follicles left in the ovary, and is correlated with the response~     to ovarian stimulation using exogenous gonadotropin. Serum anti-Müllerian hormone (AMH) has~     been accepted as the most reliable and easily measurable marker for postoperative assessment~     of ovarian reserve.~      The investigators conducted a multicenter, large-scale, randomized controlled trial to~     investigate whether hemostasis by Floseal was superior to that by bipolar coagulation in~     preserving ovarian reserve by assessing serial AMH levels in patients undergoing laparoscopic~     ovarian cystectomy for benign ovarian cysts.~   "
130633|NCT01857453|"~     Adult medulloblastoma is a rare tumour.~      The standard risk  group (complete surgery or residual tumour lower than 1,5 cm2, absence~     of malignant cells in the cerebrospinal fluid, absence of metastasis, absence of MYC~     amplification and exclusion of large cells medulloblastoma) concerns, for the adult~     population, a majority of patients at diagnosis (about ¾ of cases).~      Conventional treatment is classically based on a 54/36 Gy cranio-spinal radiotherapy (54 Gy~     on the posterior fossa and 36 Gy on the nevraxis).~      This treatment is associated with an acute toxicity (haematological, cutaneous, digestive and~     general) wich decreases gradually when patient goes away from the treatment period.~      For this category of patients and this modality of treatment, The French intergroup~     experience, pleads in favour of a late and progressive neurotoxicity.~      This neurotoxicity is associated with a clear degradation of the quality of life.~      In the light of paediatric studies :~      We propose a phase II study to estimate the interest of a decrease of radiation doses~     compensated by a chemotherapy according to the following schedule~        1. carboplatine + etoposide based chemotherapy every 28 days x 2~        2. followed by, less than 80 days after the surgery, radiation therapy with 24 Gy on the in~          toto neuro axis and 54 Gy on the post operative bed.~      The majority of French centres concerned with the neuro-oncology are involved in this trial.~      About 25 new cases by year are waited. A centralized analysis of pathological slides and of~     the pre and post surgery Magnetic Resonance Imaging is foreseen.~      The main objective is to estimate the survival without disease at 1 year~      Secondary objectives associate the evaluations of the rate of complete response at the end of~     procedure, the overall survival, the survival without disease, the survival without events,~     the neurocognitiv toxicity, the endocrine toxicity, the hearing toxicity and the time until~     definitive deterioration of the quality of life Associated studies~      Two associated studies are besides foreseen (parallel search for co-financing):~        1. A biologic study is planed with the aim to confirm, by morphological, genomic and~          transcriptomic studies, the interest, for the adult population, of the prognostic~          markers used in paediatric population~        2. A radiological study is planed with the aim to estimate the interest :~             -  of a multimodal follow-up (spectroscopy and perfusion imaging) for the premature~               detection of recurrences~             -  of the study of functional connectivity in correlation with the neuropsychological~               follow-up for the analysis of the aetiology and premature markers of neurotoxicity.~   "
130634|NCT01857440|"~     This study is designed to investigate whether the pupil response to slowly flashing colored~     lights is significantly altered in patients with glaucoma, as compared to a control group of~     subjects without glaucoma.~   "
130635|NCT01857427|"~     The primary objective of this study is to build a well characterized cohort of patients that~     will be used to determine the genetic variants associated with obstructive sleep apnea~     (OSA)and its co-morbidities.~   "
130636|NCT01857414|"~     The aim of the the study is to investigate whether Remote Ischaemic Conditioning (RIC) can~     improve clinical outcomes (cardiac death and hospitalisation for heart failure) at one year~     in patients presenting with ST-elevation Myocardial Infarction and undergoing primary~     percutaneous coronary intervention. This will be done in a multinational investigator-driven,~     multi-centre, randomised, controlled, single-blind, parallel assignment, prospective clinical~     efficacy trial.~   "
130637|NCT01857401|"~     There is currently no experimental model that accurately represents sarcoidosis. The lack of~     a useful research model significantly slows progress towards developing new treatments for~     sarcoidosis. The investigators plan to develop a new model for sarcoidosis research and will~     test the model to see if it helps us understand how sarcoidosis develops and if it is useful~     for testing new treatments.~   "
130638|NCT01857388|"~     Implementation of an adapted ParentCorps program in Ugandan schools will improve school~     mental health service resources, teachers' knowledge about child mental health, and teachers'~     classroom behavioral management and parent involvement skills.~   "
130639|NCT01857375|"~     This research is to determine the use of insulin pens compared to syringe and vial therapy in~     adults newly begun on insulin therapy during their hospital stay.~   "
130640|NCT01857362|"~     The purpose of this study is to evaluate the bioequivalence between Orfadin 20 mg and 10 mg~     capsules in healthy volunteers.~   "
130641|NCT01857349|"~     The goal of this study is to determine the superiority of surgical scrub preparations in~     total knee arthroplasty based on the bacterial counts present on the skin surface and in the~     deep joint tissues. These counts will be obtained by culturing the skin prior to any scrub~     preparation, post preparation after the application of the sterile drapes, deep joint tissue~     sample prior to wound closure, and immediately post wound closure. This study will provide an~     assessment of the management of sterility by comparing quantitative and qualitative cultures~     immediately after surgical scrub preparation and the maintenance of sterility throughout the~     procedure. This study will enhance prior research efforts by contributing quantitative~     bacterial load and bacterial load within the surgical wound at closure.~   "
130642|NCT01857336|"~     Poor graft function (PGF) is a common complication after allogeneic stem cell~     transplantation, which was associated with high mortality. The pathogenesis fo PGF was poorly~     understood. Infusion of donor peripheral cell harvest was effective for some patients with~     PGF in our preliminary study. This present study aimed to explore the efficacy of peripheral~     cell harvest for poor graft function.~   "
130643|NCT01857323|"~     This is a prospective, open-label, multicenter Phase 3 study evaluating the performance of~     the Albuterol Spiromax dose counter in patients with a diagnosis of asthma and/or COPD. The~     purpose of this study is to evaluate the functionality, reliability, and accuracy of the~     Albuterol Spiromax inhaler integrated dose counter in a clinical setting.~   "
130898|NCT01853995|"~     The aim of the current controlled trial was to assess the possible net skeletal and dental~     effects of FLMGM treatment in relation to growth with emphasis on the contribution of~     skeletal and dental changes to sagittal correction of Cl II/1 malocclusion.~      The null hypothesis stated that there were no significant differences in dentoskeletal~     changes between FLMGM treated group and control untreated group.~   "
130644|NCT01857310|"~     The overarching goal of this trial is to determine if an intervention comprising folic acid~     and zinc dietary supplementation improves semen quality and indirectly fertility outcomes~     (i.e., live birth rate) among couples trying to conceive and seeking assisted reproduction.~     The following study objectives underlie successful attainment of the overarching research~     goal:~        1. To estimate the effect of folic acid and zinc dietary supplementation on semen quality~          parameters, including but not limited to concentration, motility, morphology, and sperm~          DNA integrity, relative to the placebo group.~        2. To estimate the effect of folic acid and zinc dietary supplementation on fertility~          treatment outcomes [fertilization, embryo quality, implantation/human Chorionic~          Gonadotropin (hCG) confirmed pregnancy, clinical pregnancy, live birth], relative to the~          placebo group.~        3. To estimate the association between semen quality parameters, sperm DNA integrity and~          fertility treatment outcomes (fertilization, embryo quality, clinical pregnancy, live~          birth) and to identify the best combination of semen quality parameters for prediction~          of clinical pregnancy and live birth.~        4. To estimate the effect of folic acid and zinc dietary supplementation on fertilization~          rates among couples undergoing assisted reproductive technology procedures, relative to~          the placebo group.~        5. To estimate the effect of folic acid and zinc dietary supplementation on embryonic~          quality among couples undergoing assisted reproductive technology procedures, relative~          to the placebo group.~   "
130645|NCT01857297|"~     This is a study to assess the immune (antibody) response and safety of the 2013/2014~     formulation of Enzira® vaccine in healthy adult volunteers aged 18 years or older.~   "
130646|NCT01857284|"~     Though ursodeoxycholate acid (UDCA) is the wellknown effective therapy for PBC, clinical~     effectiveness of UDCA may be limited by its poor absorption and extensive biotransformation.~     The more hydrophilic bile acid tauroursodeoxycholate (TUDCA) is the active ingredients of~     UDCA, and has been approved by state food and drug administration in China for treatment of~     cholesterol stones. So it is necessary to verify the efficacy and safety of TUDCA in the~     treatment of adult primary biliary cirrhosis. In this randomized, double-blinded,~     double-dummy, parallel-controlled and multicenter clinical trial, we detect the proportion of~     patients who had AKP decline more than 25% as the primary outcome; decline of AKP, total~     bilirubin, GGT, ALT and AST as secondary outcomes after patients were treated with TUDCA or~     UDCA for 24 weeks.~   "
130647|NCT01857271|"~     This phase II trial studies how well erlotinib hydrochloride works before surgery in treating~     patients with stage III non-small cell lung cancer. Erlotinib hydrochloride may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving~     erlotinib hydrochloride before surgery may make the tumor smaller and reduce the amount of~     normal tissue that needs to be removed.~   "
130648|NCT01857258|"~     The objective of this study is to formulate and validate a green tea confection (i.e. gummy~     candy) as a strategy to attenuate postprandial hyperglycemia-induced impairments in vascular~     function. The central hypothesis is that a green tea confection will protect against vascular~     endothelial dysfunction by suppressing postprandial hyperglycemia. The central hypothesis of~     this application will be assessed by developing a green tea-containing confection, examining~     its physiochemical properties and its inhibition of starch digestion, and then validating its~     vasoprotective activities in healthy humans by assessing its blood glucose-regulating~     activities.~   "
130649|NCT01857245|"~     Injection drug users (IDUs) constitute 60% of the approximately 5 million people in the U.S.~     infected with hepatitis C virus (HCV). HCV treatment leading to sustained viral response~     (SVR) is associated with increased survival. However, IDUs have had poor access to HCV care~     and their success in HCV treatment has been limited. With direct-acting antiviral agents, HCV~     treatment delivered within large clinical trials leads to SVR or cure in over 70% of~     genotype-1 infected patients, compared to 45% with previous therapies. However, SVR rates are~     as low as 14% in real-world settings. The majority of patients who fail to achieve SVR will~     develop drug resistance, but the optimal adherence level to minimize resistance is unknown.~     If HCV treatment continues to be delivered within current models of care, most IDUs will not~     only fail treatment and develop resistance, but may transmit resistant viruses to others. We~     have previously developed a multidisciplinary model of HCV care which integrates on-site~     primary care, substance abuse treatment, psychiatric care, and HCV-related care within opiate~     agonist treatment clinics. To maximize treatment outcomes, we piloted two models of intensive~     HCV-related care: directly observed therapy (DOT), and concurrent group therapy (CGT). In our~     DOT model, pegylated interferon is administered once weekly, if applicable, and one daily~     dose of oral medication is administered at the methadone window. In our CGT model, patients~     initiate HCV treatment within a once weekly treatment group which provides powerful social~     support to mitigate fears of side effects, promote efficient education, and deliver weekly~     injections, if applicable. It is unknown whether either model is better or more~     cost-effective than standard on-site care.~      PREVAIL 1: In the proposed study, 150 IDUs with chronic HCV (genotype 1) will be recruited~     from methadone clinics and randomized to one of three models of care: DOT; concurrent group~     treatment; or standard on-site care. Our specific aims are: 1) To determine whether either of~     two intensive on-site HCV treatment models (DOT or concurrent group treatment) is more~     efficacious than standard on-site treatment for enhancing adherence and SVR, and decreasing~     drug resistance; (2) To determine the incidence and factors associated with the development~     of drug resistance in IDUs; (3) To perform cost and cost-effectiveness analyses of each~     model; (4) To examine the impact of HIV coinfection on adherence and virologic outcomes among~     HCV-infected IDUs.~      PREVAIL 2: In the proposed study, 60 IDUs with chronic HCV (genotypes 1 2, 3 and 4) will be~     recruited from opiate agonist treatment programs and started on HCV treatment. Subjects will~     be offered the choice of model of care (either standard on-site, DOT, or concurrent group~     treatment). Our specific aims are: (1) to determine rates of adherence and SVR in a cohort of~     opiate agonist treatment patients initiating treatment with sofosbuvir-based regimens and (2)~     to determine adherence rates over time in drug users (genotype 3 and genotype 1 /~     IFN-ineligible) initiating a 24 week IFN-free regimen.~      PREVAIL 3: In the proposed study, 60 IDUs with chronic HCV (genotype 1 and 4) will be~     recruited from opiate agonist treatment programs and started on HCV treatment. Subjects will~     be offered the choice of model of care (either standard on-site, DOT, or concurrent group~     treatment). Our specific aims are: (1) to determine rates of adherence and SVR in a cohort of~     opiate agonist treatment patients initiating treatment with oral DAA combination of~     sofosbuvir and simeprevir or fixed dose of sofosbuvir and ledipasvir and (2) to determine~     adherence rates over time in drug users.~   "
130650|NCT01857232|"~     Comparison of efficacy of APD403 at preventing delayed sickness in patients who have received~     cancer chemotherapy~   "
130651|NCT01857219|"~     To accomplish our Specific Aims, we propose to conduct a two-session fMRI experiment in up to~     30 patients with fibromyalgia (FM) and up to 30 healthy controls. All subjects will be~     invited to complete the second, identical fMRI session about 3 months following completion of~     the first session. Fibromyalgia subjects will complete their scans before and after a 12-week~     Tai Chi intervention in collaboration with Tufts Medical Center.~   "
130652|NCT01857206|"~     Evaluate safety and tolerability of TIVa or TIVb vaccine in healthy children and adolescents~     4 to 17 years of age.~   "
130653|NCT01857193|"~     Dose Escalation part of the study: To estimate the MTD(s) and/ or RP2D of LEE011 in~     combination with everolimus + exemestane, and LEE011 in combination with exemestane, and to~     characterize the safety and tolerability of the combinations of everolimus + exemestane +~     LEE011 and LEE011 + exemestane in patients with ER+ HER2- advanced breast cancer~      Dose Expansion part of the study: To characterize the safety and tolerability of the triplet~     combination of LEE011 + everolimus + exemestane in patients naïve or refractory to CDK4/6~     inhibitor based therapy, and the safety and tolerability of the doublet combination of LEE011~     + exemestane in patients refractory to CDK4/6 inhibitor based therapy (except patients~     treated with prior LEE011 are not allowed in Group 3).~   "
130654|NCT01857180|"~     Laparoscopic surgery has become the standard approach to a vast variety of surgical~     procedures. Due factors such as 2D- to 3D conversion, reduced tactile sensation,~     amplification of tremor and fulcrum effect of the abdominal wall, surgeons require a~     different set of skills than in open access surgery. Acknowledging this, several~     comprehensive curricula have been developed to teach basic skills as well as advanced~     laparoscopic procedures. Despite a recent emphasis on early exposure of medical students to~     surgery no designated curricula have been developed to introduce medical students to the~     technique of laparoscopic surgery.~      Participation in an introductory curriculum in laparoscopic surgery results in improved~     cognitive and technical performance compared to self-directed learning. The greater~     homogeneity and fewer dropouts amongst those in the curriculum group suggest that a~     structured curriculum is essential in ensuring standardization of clinically relevant~     training. An introductory curriculum for medical students should be delivered in a structured~     and standardized fashion prior to clinical exposure in order to maintain motivation and~     enhance learning.~   "
130655|NCT01857167|"~     This study is to examine the change of fasting insulin, glucose, insulin sensitivity and~     related traits in response to the six month treatment of omega-3 fatty acids, including fish~     oil and flaxseed oil, in Chinese type 2 diabetic patients. Corn oil, rich in omega-6 fatty~     acids, will be selected as a controlled oil. The investigators hypothesize that omega-3 fatty~     acids could improve insulin sensitivity and glucose metabolism in Chinese type 2 diabetic~     patients.~   "
130656|NCT01857154|"~     The purpose of this study is to determine whether consuming calcium carbonate that has been~     micronized is more effective than the traditional form of calcium carbonate in maintaining or~     increasing bone mineral density in people who are currently taking bisphosphonates or other~     bone-health medications.~   "
130657|NCT01857141|"~     The use of epidural dexmedetomidine decreases the anaesthetic requirements and improved~     postoperative pain. Dexmedetomidine is a potent and highly selective a2-adrenoceptor agonist~     and has sympatholytic effect. Power spectral analysis of heart rate variability(HRV) is a~     useful tool to assess cardiac autonomic activity. We investigated whether preemptive epidural~     dexmedetomidine can develop hemodynamic change and it could be identify patients by HRV.~   "
130658|NCT01857128|"~     The purpose of the study is to learn about the best way to treat pilonidal cyst wounds and~     learn which type of bandage (or dressing) can help the wound heal faster after having~     surgery.~   "
130659|NCT01857115|"~     This protocol is a phase I/II multicenter study designed to assess the safety and the~     efficacy of the proposed combinations as up-front treatment in elderly Multiple Myeloma (MM)~     patients.~   "
130660|NCT01857102|"~     The purpose of this study is to determine the benefits of fitting low astigmats with soft~     toric contact lenses versus spherical contact lenses with regard to visual comfort,~     eyestrain, fitting efficiency, and visual performance.~   "
130661|NCT01857089|"~     The aim of this study is to assess the intra and inter-subjects variability of the pressure~     measurement cartography in healthy and well and able volunteers, sitting on a rigid base~     during two hours.~   "
130662|NCT01857076|"~     There will be a randomized clinical trial, non-blind, 3-arm treatment (medical, surgical,~     gastric bypass and ileal transposition surgery with and sleeve), which will be conducted in a~     single center - S.B.S. Hospital Sirio Libanês, including 75 research subjects with type 2~     diabetes mellitus and obesity class I. In order to compare the effect of weight loss on~     glycemic control among medical and surgical groups, and after 2 years of follow up, the~     results of efficacy, safety and maintenance will be compared between the three groups.~   "
130663|NCT01857063|"~     This study will evaluate the efficacy and safety of montelukast (MK-0476) in the treatment of~     Japanese pediatric participants with seasonal allergic rhinitis (SAR). The primary hypothesis~     of this study is that montelukast is superior to placebo in the treatment of nasal symptoms~     in SAR.~   "
130664|NCT01857050|"~     Many drug interactions with Warfarin are well documented in the literature, including~     interactions with a variety of antibiotics. However,in mamy cases it is difficult to predict~     when the interaction remains theoretical and when it becomes clinically significant and will~     be reflected in the individual patient. This study's aim is to identify and characterize~     related conditions (including comorbidities, laboratory test results and other parameters~     related to the patient)that might be predictors for drug interactions turning from~     theoretical to clinically significant.~   "
130665|NCT01857037|"~     Inclusion criteria:~        -  Patients with biochemical recurrence (Phoenix criteria: PSA nadir + 2 ng/ml) after~          radiation therapy for prostate cancer addressed for prostate biopsy OR~        -  Patients referred to our institution for biopsy-proven local recurrence after radiation~          therapy for prostate cancer but needing a re-assessment with biopsy (insufficient number~          of biopsy and/or imprecise location of positive biopsy and/or questionable diagnostic of~          recurrence)~      Study Design:~        -  Included patients will undergo an endorectal US examination with a Histoscanning™~          acquisition and a multiparametric (T2-weighted, diffusion-weighted and dynamic~          contrast-enhanced) MRI.~        -  Two independent operators will separately define suspicious focal lesion on~          Histoscanning™ images and on MR images.~        -  Random biopsies (at least 2 cores) will be performed in sextants negative at~          Histoscanning™ and at MRI ; In sextants positive at Histoscanning™ and/or at MRI,~          targeted biopsies will be performed in the suspicious part of the sextant (at least two~          cores per suspicious lesion).~        -  Histoscanning™ and MRI results will be compared to biopsy results.~      A total of 30 patients will be included~   "
130666|NCT01857024|"~     The primary objective of this study is to assess in a post-approval clinical setting the~     safety profile of sevelamer carbonate (Renvela®) tablets and powder in adult~     hyperphosphataemic chronic kidney disease (CKD) patients not on dialysis with serum~     phosphorus ≥1.78 mmol/L. Patients will be treated in accordance with the Renvela® Summary of~     Product Characteristics (SmPC) and followed according to the investigator's standard clinical~     practice management. Each patient will be followed up for 12 months or up to the time they~     start dialysis, whichever occurs first.~   "
130667|NCT01857011|"~     The purpose of this study is to determine whether intravenous or oral iron are effective in~     the treatment of postoperative anemia and iron deficiency in patients submitted in~     postbariatric abdominoplasty.~   "
130669|NCT01856985|"~     These pilot studies are designed as open label studies to investigate the acceptability of~     200 mg mifepristone followed 24-48 hours later by either 1) 800 µg misoprostol administered~     buccally or 2) 800 µg misoprostol administered sublingually for medical abortion in~     gestations 78-84 days' LMP. They will be done consecutively.~      Findings from the pilot studies will guide the development of a larger, multi-site study to~     investigate the efficacy of outpatient medical abortion regimens for women with gestations~     from 78 - 84 days LMP. In that end, the pilots seek to collect information on the~     acceptability of an outpatient medical abortion regimen of 200 mg oral mifepristone followed~     by either 800 mcg misoprostol delivered either buccally or sublingually safe acceptable?~     Women's rating of the tolerability of any side effects will also be documented.~   "
130670|NCT01856972|"~     This study will examine the short term effects of adding manual therapy techniques to static~     stretching in Dorsiflexion (DF) Range of Motion (ROM). The investigators will be studying 2~     forms of manual therapy, a rear-foot thrust joint mobilization (TJM), and Instrument assisted~     soft tissue mobilization (IASTM). By comparing 3 groups: TJM+static stretching versus IASTM +~     static stretching versus static stretching alone the investigators wish to see if there are~     any short term benefits in DF ROM by adding either of these interventions to static~     stretching.~      The manual therapy treatment will occur over 2 sessions and DF ROM measurements will be taken~     4 times over a 2 week period.~      The population that the investigators wish to examine are subjects with healthy feet and~     ankles, but with limited DF ROM.~      The primary objective of this study is to see if subjects with decreased dorsiflexion motion~     will experience greater increases in dorsiflexion motion with the addition of manual therapy~     of static stretching alone.~      Our hypothesis is subjects who receive manual therapy therapy and static stretching will~     experience a significant increase in DF ROM as compared to subjects who receive static~     stretching alone. More specifically subjects who are treated with the IASTM will experience~     greater results than subjects who are treated with the rear-foot thrust mobilization.~   "
130671|NCT01856959|"~     As a non-selective bronchodilator, magnesium sulfate (MgSO4) is effective when administered~     intravenously in the treatment of the patients with acute severe asthma not responding to~     conventional therapy (oxygen, nebulized salbutamol, and corticosteroids), which can resulted~     in earlier improvement in clinical signs and symptoms of asthma and PEF. However, the use of~     intravenous MgSO4 administered is not common in clinical practice, because it's prone to have~     adverse effects and side effects such as nausea, vomiting, facial flushing, hypotension,~     decreased tendon reflexes and so on with this treatment. The aerosolised route offers the~     advantage of lower dosage, a shorter time of drug being delivered to the airway smooth muscle~     and lower incidence of side effects when compared to the intravenous route. At present, there~     are only a few studies about the effects of nebulized MgSO4 in the treatment of acute asthma~     in children, and the conclusions are controversial.~   "
130672|NCT01856946|"~     Childhood obesity is a rapidly growing epidemic in the US and the world. Current estimates~     suggest that 30% of our nation's children are either overweight ot obese. Obesity is a major~     risk factor towards the development of insulin resistance, which, in turn is a major risk~     factor for the development of type 2 diabetes. Prior research has suggested that vitamin D~     therapy may be a safe, inexpensive, and effective method of reducing insulin resistance and a~     person's risk of developing diabetes.~      The investigators' prior studies have shown that daily 4,000 IU vitamin D therapy is a safe~     and effective method of improving insulin resistance based on a calculation called the~     HOMA-IR.~      The next step in identifying whether vitamin D truly improves insulin resistance is to use~     oral glucose tolerance testing (OGTT), which is a better real-life measure of insulin~     resistance compared to the previously used HOMA-IR.~   "
130673|NCT01856933|"~     The purpose of this study is to evaluate the effectiveness of Prostate Specific Membrane~     Antigen (PSMA ADC), as well as its safety and side effects for patients with advanced brain~     tumors. This study will also study how your body metabolizes (breaks down) PSMA ADC.~   "
130674|NCT01856920|"~     Background:~      - GI-6207 is an experimental cancer vaccine made with baker's yeast. The yeast has been~     modified to help the immune system target a protein called CEA. CEA is found on the surface~     of some kinds of tumor cells, including thyroid cancer cells. Researchers want to see if~     GI-6207 can encourage the body's immune system to attack and kill tumor cells that contain~     the CEA protein. They will test to see whether this vaccine is a safe and effective treatment~     for medullary thyroid cancer that has not responded to earlier treatments.~      Objectives:~      - To test the safety and effectiveness of the GI-6207 vaccine for advanced medullary thyroid~     cancer.~      Eligibility:~      - Individuals at least 18 years of age who have medullary thyroid cancer that has not~     responded to earlier treatments.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will~          provide blood and tumor samples and have an imaging study of the neck and chest. They~          will also have a skin test to make sure that they are not allergic to the yeast in the~          vaccine.~        -  Participants will be divided into two groups. One group will start to take GI-6207~          immediately for 1 year. The second group will have 6 months of monitoring and tests with~          no vaccine, and then will take GI-6207 for 1 year.~        -  GI-6207 will be given every other week for the first seven visits (about 3 months), and~          then monthly for the remaining year of treatment. It will be given as injections beneath~          the arm and in the upper thigh. These locations will help the vaccine enter the lymph~          nodes and reach the immune system more quickly.~        -  Participants will be monitored with frequent blood and urine tests and imaging studies.~        -  Participants will have regular follow-up visits after their year of study vaccines.~   "
130675|NCT01856907|"~     Gestational diabetes mellitus (GDM) is defined as any degree of glucose intolerance with~     onset or first recognition during pregnancy. GDM is one of the most frequent metabolic~     disorders occurring during pregnancy. Approximately 7% of all pregnancies in the United~     States are complicated by gestational diabetes resulting in more than 200,000 cases annually.~     There is epidemiologic evidence associating GDM with insulin resistance, glucose intolerance,~     and type 2 diabetes (DM2). Among all the risk factors of diabetes mellitus, the experience of~     gestational diabetes is the strongest one. Systematic reviews of older studies conclude that~     35-60% women with gestational diabetes will develop type 2 diabetes at rates much greater~     than control groups who did not have glucose intolerance during pregnancy. Studies are needed~     for optimal postpartum and long-term health of women who have had GDM. Recent evidence~     suggests that incretin-based therapies may be useful for the treatment of DM2 because~     continuous administration of glucagon-like peptide 1 (GLP-1) produces substantial~     improvements in glucose control and ß-cell function in subjects with DM2. Inhibition of~     dipeptidyl peptidase-4 (DPP-4) increases the concentration of GLP-1 and may potentially delay~     disease progression in GDM considering the ß-cell function improvement in DM2 and ß-cell mass~     shown to increase in animal models. This study will examine if combination sitagliptin (a~     DPP-4 inhibitor)-plus metformin is more effective than metformin alone or placebo in~     improving metabolic parameters, specifically the impact on β-cell function, in prior GDM~     women with glucose abnormalities.~   "
130676|NCT01856894|"~     In this study the investigators aimed to investigate whether there is a relation between body~     weight and serum anti mullerian hormone levels in adults with polycystic ovary syndrome. For~     this purpose the investigators designed a prospective study including three groups. The group~     I is defined as adults with polycystic ovary syndrome and body mass index is greater than 25.~     The group II is defined as adults with polycystic ovary syndrome and body mass index is less~     than 25. The group III is defined as adults with non-polycystic ovary syndrome and body mass~     index is less than 25. The all three groups are compared considering their serum AMH~     levels,lipid profiles, sex steroids and glycemic analyses.~   "
130677|NCT01856881|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and~     pharmacodynamics following ascending multiple doses of AMG 876 in subjects with type 2~     diabetes.~   "
130678|NCT01856868|"~     (-)-Epicatechin will be evaluated for the treatment of progressive muscle loss and impaired~     skeletal muscle function in Becker Muscular Dystrophy (BMD) patients.~   "
130679|NCT01856855|"~     This study will investigate the safety, tolerability, and effectiveness of giving a higher~     dose to the part of the prostate which contains the cancer while giving a standard radiation~     dose to the entire prostate. The investigators have hypothesized that this treatment~     technique will effectively control the prostate cancer while minimizing the side effects.~   "
130680|NCT01856842|"~     AVMs are abnormal collections of blood vessels which can occur in any part of the body~     including the lungs. These blood vessels are weakened and can rupture anytime causing~     bleeding which can be massive, leading to life-threatening conditions.~      Pulmonary AVMs occur in about 40% of patients with HHT. Each patient may have an average of 5~     AVMs .Rupture of the AVM can lead to massive bleeding in the lung, stroke and infection of~     the brain. In order to prevent these complications, patients with HHT are routinely examined~     for pulmonary AVMs and treatment with embolization is recommended.~      AVMs have a main blood vessel or artery supplying blood to the collection of blood vessels.~     The way to treat AVMs is cut off their blood supply through a process called embolization.~      Embolization is a standard medical procedure which is done to stop or prevent hemorrhage~     (bleeding) from an AVM. It involves blocking the artery that supplies blood to the AVM by~     inserting a foreign body, into the blood vessel supplying blood to the AVM.~      Standard devices used for embolization include coils (made of stainless steel or platinum).~     These devices usually have a good success rate for blocking the artery that supplies blood to~     the AVM. However, a few AVMs that are embolized by standard devices may reopen over time.~     This is called reperfusion and will require repeat embolization procedures.~      For embolization of pulmonary AVMs at St. Michael's Hospital, the Nester coil is used. In~     this study, we would like to compare the Nester coil with a new coil device called the~     Interlock Fibered IDC Occlusion System. Both coils are approved for use in Canada, however~     the cost of the IDC coil limits its use at this hospital.~      Compared to the Nester coil, the IDC coils are made so that they can be removed or~     repositioned if they are not placed correctly. The coil also allows tighter packing which~     helps prevent reperfusion.~      This study will compare the success rate of embolization between the Interlock™ Fibered IDC™~     Occlusion System (IDC coil) and the Nester coil.~   "
130681|NCT01856829|"~     Omega 3 in the form of phospholipids are the main component of nerve cells and their oral~     intake is known to have a positive impact on behavior disorders such as depression or bipolar~     disorder. Their consumption would improve brain function while increasing the ability to~     concentrate. The study aims to determine the effect of an increase in Omega 3 in the form of~     phospholipids on the processing of visual information in the brain and in particular the~     attention and perceptual-cognitive learning in a three dimensions environment. Eighty~     subjects (40 young (18-35 years) and 40 older (60-75 years)) divided into four groups, two~     Omega-3 (20 young and 20 older) and two other placebo (20 young and 20 elderly ), will in~     this study, performing a complex perceptual-cognitive task such as the pursuit of moving~     objects in a 3D space. This stimulus was chosen because it is very similar to the situations~     of daily life, but also because it involves a mechanism of perceptual-cognitive level. The~     main objective is to demonstrate the positive effect of Omega-3 phospholipids on the~     perceptual-cognitive training.~   "
130682|NCT01856816|"~     The purpose of this research study is to determine how different meal patterns influence the~     absorption of beneficial plant pigments (carotenoids) from vegetables. The hypothesis is that~     carotenoid absorption will be lower when daily vegetables are consumed in one meal compared~     two smaller meals throughout the day.~   "
130683|NCT01856803|"~     Age is a risk factor for graft-versus-host disease (GVHD) after human leukocyte antigen~     (HLA)-matched sibling allogeneic stem cell transplantation (allo-SCT). The incidence of acute~     GVHD is significantly higher in patients at 40 years of age or more than those at 18 to 39~     years of age after allo-SCT. It was found that Anti-thymocyte globulins can be used for~     prophylaxis of both acute and chronic GVHD after allo-SCT.Prophylaxis of GVHD using ATG in~     patients at 40 years of age or more in matched sibling allo-SCT settings might significantly~     decrease the incidence of acute and chronic GVHD and the incidence of late effect after~     transplantation.~   "
130684|NCT01856790|"~     Closed loop artificial pancreas systems have been under development for the control of~     blood sugars in those living with diabetes. These systems consist of a continuous glucose~     sensor, which sends a signal to a computer program that automatically determines how much~     insulin to give. The computer program then tells an insulin pump to deliver the insulin.~     While such systems have been tested under a number of conditions, post-meal blood sugars are~     difficult to control. This study is designed to see if liraglutide, a glucagon like peptide~     receptor agonist, can help minimize the post meal blood sugar spikes in subjects with type 1~     diabetes while they are on a closed loop system.~   "
130685|NCT01856777|"~     This randomized study will examine the effectiveness of two types of pregnancy tests (a~     semi-quantitative test and a high sensitivity test) to identify continuing pregnancy at home~     at various time points after early medical abortion. The first test a semi-quantitative panel~     test marketed under the brand name dBest (AmeriTek, Seattle WA, USA). This urine-based,~     one-step kit has been used in two previous studies in Vietnam (12, 13). The second test is a~     locally available urine dipstick (Quickstick one-step hCG Pregnancy Test, Phamatech, San~     Diego, CA, USA).~        1. The investigators hypothesize that 99% of the SQPT and 35% of the HSPT will correctly~          identify ongoing pregnancy at day 14.~        2. The investigators hypothesize that 99% of the SQPT and 25% of the HSPT will correctly~          identify ongoing pregnancy at day 7.~        3. The investigators hypothesize that 75% of the SQPT and 10% of the HSPT will correctly~          identify ongoing pregnancy at day 4.~   "
130686|NCT01856764|"~     The purpose of this study is to evaluate the effect of topical roflumilast on the reduction~     of atopic dermatitis lesions in adults with atopic dermatitis.~   "
130899|NCT01853982|"~     This is a Phase 3, multicenter, prospective, randomized, open-label, study to compare the~     safety and efficacy of intravenous (IV) ceftolozane/tazobactam with that of IV~     piperacillin/tazobactam in the treatment of ventilator-associated pneumonia (VAP) in adult~     participants .~   "
130687|NCT01856751|"~     Occurrence of inhibitors to coagulation factor VIII is diagnosed in ~30% patients with~     haemophilia A. Presence of inhibitor with a titre >5 BU/ml requires the use of by-passing~     agents: recombinant activated Factor VIIa concentrate (rFVIIa) and/or activated prothrombin~     complex concentrate (APCC). Similarly, haemorrhagic complications in patients with acquired~     haemophilia and inhibitor titre >5 BU/ml should be treated with by-passing agents.~      Response to treatment with by-passing agents is patient-specific, and can vary in the same~     patient during subsequent bleedings. Some patients have good response to both products,~     however in other patients a better bleeding control is provided by one of the mentioned above~     agents (APCC or rFVIIa). There are clinical situations when severe bleedings requires an~     alternate use of both these agents.~      Traditional methods of laboratory tests used post-treatment in patients with haemophilia~     without inhibitors are useless in the presence of inhibitor. Laboratory monitoring of therapy~     with by-passing agents is possible with the use of global tests for the coagulation process~     assessment, which are as follows: thrombin generation assay (TGA) and thromboelastometry~     (TEM).~      Several studies revealed that TGA allows a monitoring of therapy with by-passing agents in~     patients with haemophilia A and inhibitor - the choice of the most effective treatment option~     - agent type and its dose, as well as laboratory assessment of treatment efficacy.~      Up to date, laboratory tests assessing the efficacy of by-passing agents in patients with~     acquired haemophilia were not conducted.~      In Factor VIII or IX deficiency conditions, fibrin's fibres generated by thrombin are~     morphologically thicker, and blood clots have increased susceptibility to fibrinolytic~     enzymes. Blood clot stability may be assessed with the use of thromboelastometry (TEM). We~     can hypothesize that simultaneous use of TGA and TEM methods may allow for an assessment of~     patient's individual response to therapy with by-passing agents. Clinical significance of the~     minimal dose of APCC and rFVIIa, needed to TGA and TEM normalization, requires further~     studies.~      Tests' purpose: Examination of the hypothesis that simultaneous use of thrombin generation~     assay (TGA) and thromboelastometry (TEM) may facilitate the choice of optimal therapy with~     by-passing agents and laboratory monitoring of efficacy of those agents in patients with~     acquired haemophilia or haemophilia A with inhibitor.~   "
130688|NCT01856738|"~     Rationale: Visual hallucinations (VH) are the most common non-motor symptoms in Parkinson's~     disease (PD). As an independent predictor for cognitive decline and nursing home placement~     they form an important disability milestone in the course of PD. According to current~     clinical guidelines minor VH do not require treatment per se. But as minor VH precede the~     stage of major VH without insight and PD associated psychosis (PDP) they offer an opportunity~     for early intervention. Neuroleptic drugs delay the transition into PDP but are unsuitable~     for early treatment of VH due to their side effects. We hypothesize that cholinesterase~     inhibitors (ChEI) are a well-tolerated alternative for the early treatment of minor VH to~     delay the progression to PDP, and that brain network analysis is suitable to predict~     treatment response.~      Objective: Investigate whether early treatment with ChEI delays the progression of minor VH~     to major VH without insight or PDP. In addition, we will measure motor control, psychotic~     symptoms, cognitive impairment, mood disorders, daytime sleepiness, adverse events and~     compliance, disability, caregiver burden and care use. We assess the cost-effectiveness of~     early chronic treatment of VH with ChEI. Finally, we analyse changes of functional brain~     networks before and during treatment.~      Study design: A randomized, double blind, placebo-controlled, multi-center trial with an~     economic evaluation.~      Study population: 168 patients with PD and VH after fulfilling the in-and exclusion criteria.~      Intervention: Rivastigmine capsule 6 mg BID or placebo BID for 24 months.~      Main study parameters/endpoints: The primary outcome measure is the median time until PD~     patients with minor VH progress to major VH without insight. The clinical endpoint is defined~     as the start with antipsychotic treatment. Secondary outcome measures are changes in motor~     control, psychotic symptoms, cognitive impairment, mood disorders, daytime sleepiness,~     cholinergic deficiency, the number of adverse events, compliance, disability and caregiver~     burden. The median time until PD patients with minor VH progress to PD dementia is measured~     by means of changes in cognitive function. The secondary neurophysiological outcome measures~     are peak frequency, functional connectivity, topological network organisation and the~     direction of information flow. All relevant costs will be measured and valued.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: The burden of participation consists of a total of 5 clinical visits (every 6~     months), 5 telephone interviews on adverse events during the escalation phase and 9~     questionnaires on health related costs (every 3 months). In a subgroup 3 additional visits~     for EEG recording are needed. There is a risk for adverse reactions with rivastigmine~     treatment; the most common are nausea and vomiting.~   "
130689|NCT01856725|"~     The purpose of this study is to compare the efficacy of cardiac resynchronization therapy~     (CRT) device programming with hemodynamic measurements to device programming without~     hemodynamic measurements.~   "
130690|NCT01856712|"~     The over-arching goal of the proposed project is to understand the impact of medication~     adherence upon engagement in behavioral treatment for alcohol use disorders. The proposed~     project is a pilot feasibility study of inpatient veterans with problem alcohol use at the~     William S. Middleton VA Hospital (Madison, WI). Participants will be randomized to one of two~     parallel study conditions: (1) an initial 50 mg oral dose of naltrexone prior to hospital~     discharge plus a 30-day prescription for oral naltrexone, or (2) a single 380 mg~     intramuscular injection of naltrexone administered prior to discharge and a second injection~     one month later. The central hypothesis is that hospital-administered injectable naltrexone,~     when compared to daily oral naltrexone taken at home, will reduce alcohol use in the days~     immediately following hospitalization. Injectable naltrexone has been efficacious vs. placebo~     in addition to behavioral treatment in several studies. However, it has yet to be examined in~     head-to-head comparison with oral naltrexone, or in the hospital setting as an intervention~     that might facilitate behavioral treatment follow up after discharge.~   "
130691|NCT01856699|"~     Aim of the SuSPect-CAA study is to prospectively evaluate the prognostic significance of~     cortical superficial siderosis in patients with suspected cerebral amyloid angiopathy with a~     primary focus on future stroke and mortality.~   "
130692|NCT01856686|"~     Multicenter, Prospective, randomized, comparative and controlled study about the beneficial~     effects in behavior and brain connectivity of different dietary patterns in 100 children with~     ADHD between 7 and 12 years, followed up for 3 months of nutritional therapy.~   "
130693|NCT01856673|"~     This study is a community prevention randomized trial with three parallel groups: two~     intervention groups and one control group in Buenaventura and Quibdó.~      The aim of the trial is to evaluate the impact of two community interventions on mental~     health; the intervention groups are designed to decrease depression, anxiety, post-traumatic~     stress disorders symptoms as well as the level of dysfunctionality in Afro-Colombian victims~     of violence.~      Adult people (equal or more than 18 years old) belonging to Afro-Colombian communities in~     both cities will participate in the enter survey. The subjects will be selected based on the~     severity of symptoms, traumatic experiences and a level of dysfunction identified using the~     instruments of this research (i.e. those obtaining an score equal or higher than 49 in~     symptoms (25% of the total of symptoms)).~      The fieldwork and the interventions will be conducted by people belonging to the community;~     they are called Lay Psychosocial Community Workers (LPCW). After six (6) weeks of formal~     training, they will be able to perform two kinds of interventions, Common Elements Treatment~     Approach (CETA) based on a cognitive behavioral intervention and Narrative Community Group~     Therapy (NCGT), for the people affected by violence and displacement that were pre-selected~     according to the baseline instrument.~      The LPCW will be under the constant supervision by psychologists of the project, and under~     weekly supervision by a group of experts from Johns Hopkins University, the Heartland~     Alliance and The Institute for Research and Development in Violence Prevention and Promotion~     of Peaceful Coexistence Social (CISALVA) by means of phone calls or monthly visits to the~     cities. Selected subjects will be randomly allocated to any study branch: CETA, NCGT or the~     waiting control group.~      The study subjects will follow their allocated treatment, or waiting in the control group,~     for 8 to 12 weeks; then they will be re-assessed using the project instrument two weeks after~     the last session of therapy.~      The study outcome is the differences in instrument scores between the follow-up and the~     baseline among the interventions (CETA or NCGT) and control group.~      Control subjects will be assessed by the project psychologist after the follow-up, and they~     will receive treatment when necessary.~   "
130694|NCT01856660|"~     Individual food preferences are not considered in designing weight-loss therapies. This~     project will determine if short-term weight-loss is improved by matching participants with~     diets that reflect their genetically-determined food preferences.~   "
130900|NCT01853969|"~     This study will investigate how soon a patient's typing proficiency returns to their~     pre-operative levels following carpal tunnel release surgery. In order to determine this,~     patients will undergo typing tests at different time points that will record their typing~     accuracy and speed. The results will then be compared to determine on average how soon a~     person returns to their pre-operative baseline results.~   "
130695|NCT01856647|"~     Obesity is an insulin resistance-associated metabolic disorder which is a hallmark of and~     risk factor for type 2 diabetes and the metabolic syndrome, often linked to cardiovascular~     disease, certain cancers and inflammatory diseases.The phenotyping of subcutaneous adipose~     tissue (SAT) hematopoetic cells from obese subjects by flow cytometry, microscopy and gene~     expression will enable us to identify inflammation in this tissue and may help us to~     understand the causes and consequences of obesity in order to determine how these cells might~     be implicated in the initiation and/or progression of the aforementioned diseases.~   "
130696|NCT01856634|"~     The purpose of this trial is to determine the pediatric dose of delamanid that is equivalent~     to the adult dose already shown to be effective against multidrug-resistant tuberculosis.~   "
130697|NCT01856621|"~     The purpose of this study is to compare the test product Salmeterol/fluticasone Easyhaler~     with the reference product Seretide Diskus in terms of drug absorbed in the bloodstream.~   "
130698|NCT01856608|"~     Assessing the utility of the Team SA instrument in measuring the effectiveness of~     communication across disciplines during ICU rounds.~   "
130699|NCT01856595|"~     The purpose of this study is to assess the safety, tolerability, pharmacokinetics and~     pharmacodynamics of multiple ascending doses of PF-06291874 in Type 2 Diabetes patients.~   "
130700|NCT01856582|"~     The purpose of this study is to determine if infusing additional special donor cells will~     help to improve graft or immune function in previously transplanted children with immune~     deficiencies and bone marrow failures.~   "
130701|NCT01856569|"~     Observe in real life adherence therapy and time to switch in ankylosing spondylitis patients~     with predominant assial involvement with 4 anti-TNF.~   "
130702|NCT01856556|"~     The primary objective of this study is to evaluate the safety and tolerability of a single~     intravenous (IV) and oral (PO) ascending dose of NRX-1074 as evidenced by the incidence and~     severity of adverse events (AEs), changes in serum chemistry, hematology, and urinalysis,~     changes in physical examination findings and subject-reported symptoms.~      The secondary objectives of this study are to assess the plasma and cerebrospinal fluid (CSF)~     pharmacokinetics (PK), the oral bioavailability of experimental formulations and the renal~     elimination through urine concentration of NRX-1074 through 24 hours following dosing.~   "
130703|NCT01856543|"~     The purpose of this study is to find out if the effect of mometasone furoate is any different~     from Eucerin in decreasing the severity of redness of the skin during irradiation, preventing~     the skin from peeling, or reducing the amount of irritation the patient reports during~     treatment.~   "
130704|NCT01856530|"~     The purpose of this study is to learn more about how the hormone, oxytocin, impacts social~     behavior in terms of cooperation with others, attention processing, and reward processing,~     among patients with social anxiety disorder. Based on available research, the investigators~     predict that in patients with social anxiety disorder, oxytocin will improve social~     cooperation during an online ball-tossing game called Cyberball, reduce attention toward~     socially threatening cues during a dot-probe task, and lead to greater willingness to work~     for monetary rewards for others rather than themselves during an effort expenditure task.~   "
130705|NCT01856517|"~     The hallmarks of septic shock are hypovolemia and reduced pressor response to endogenous~     noradrenaline. The working hypothesis is that the higher the plasma concentration of~     endogenous noradrenaline will be, the lower the pressor response to exogenous noradrenaline~     will be. This will be tested in patients presenting with septic shock, following state of the~     art management (including repeated assessment of vena cava diameter and compliance, and~     response to dynamic indices of loading) following placebo vs clonidine administration (1~     mcg.kg-1.h-1 over 24 h without bolus) and administration of increasing doses of noradrenaline~     (1 mcg, 2 mcg, etc. up to a delta systolic blood pressure circa 25-30 mm Hg).~   "
130706|NCT01856504|"~     To demonstrate the incremental utility of SSF for individuals undergoing CCTA, with expected~     improvements in image quality and diagnostic accuracy.~   "
130707|NCT01856491|"~     The objective of this study is to gather data to establish the chronic safety, performance~     and effectiveness of the RELIANCE 4-FRONT™ Passive Fixation Defibrillation Leads.~   "
130708|NCT01856478|"~     This randomized, open-label, phase III study will be performed in patients with recurrent~     and/or metastatic head and neck cancer which has progressed after platinum-based therapy. The~     objectives of this trial are to compare the efficacy and safety of afatinib versus~     methotrexate.~   "
130709|NCT01856465|"~     Non-alcoholic fatty liver disease (NAFLD) includes benign hepatic simple steatosis (SS) and~     steatohepatitis (NASH), which is characterised by inflammation leading to fibrosis and~     cirrhosis. NAFLD is the hepatic manifestation of the metabolic syndrome, and the prevalence~     is 74-98% in morbidly obese individuals undergoing bariatric surgery. Although steatosis~     improves post bariatric surgery, hepatic inflammation and fibrosis do not consistently~     improve. Alterations of the human gut flora (intestinal microbiota; IM) may play a role. One~     mechanism linking IM to obesity, insulin resistance (IR), and NAFLD is through translocation~     of bacterial lipopolisaccharide (LPS=endotoxin) into the blood stream (=endotoxemia), causing~     chronic inflammation. Morbidly obese subjects have different IM compared to lean controls,~     and the IM structure is significantly altered after bariatric surgery, probably due to a~     combination of anatomic changes, diet, and weight loss. For example, the ratio of~     Firmicutes/Bacteroidetes may be lower in obese subjects compared to lean controls and lower~     numbers of Faecalibacterium prausnitzii were reported in some obese subjects before bariatric~     surgery, which increased 3 months post-surgery. This is of interest since, in animal studies,~     low abundance of F. prausnitzii, a butyrate producing bacterium, is associated with increased~     intestinal permeability, endotoxemia, and inflammation. To our knowledge, only two studies~     are available describing IM in patients pre and post bariatric surgery, and no data have been~     published on the relationship between IM and NAFLD in these patients.~   "
130727|NCT01856231|"~     The purpose of this preliminary study is to examine the effects of a program that includes~     two-months of structured lab-based training. The proposed study will examine the effects of a~     lifestyle physical activity intervention designed to increase PA in people with moderate and~     severe COPD. The intervention includes a combination of (a) structured laboratory-based~     exercises with a behavioral intervention, (b) structured home-based exercises and (c)~     lifestyle physical activities performed at home. The subjects will be followed for a total of~     18 weeks.~   "
130710|NCT01856452|"~     Sentinel lymph node biopsy (SLNB) has become a mainstay surgery method in breast cancer. It~     provides the surgeon the evidence of axillary lymph node metastasis, which determines the~     extent of surgery. Because effective SLNB can decrease the extent of axillary lymph node~     dissection, it is increasingly important. In general, radioactive colloid has been used for~     SLNB. In order to pursue more precise SLNB, the investigators developed a multimodal method~     enabling visual guidance with the mixture of indocyanine green, blue dye and radioisotope.~      In this study, our hypotheses are as following:~        1. Multimodal method enables to increase identification rate of SLNB~        2. blue dye and indocyanine green provide the surgeon visual guidance to ensure better~          outcome~        3. Multimodal method alleviates the shortcomings of indocyanine green and blue dye as an~          identification strategy~   "
130711|NCT01856439|"~     The study is designed to assess the long term tolerability of ProSavin and whether it is safe~     and efficacious in patients administered ProSavin from the PS1/001/07 study .~   "
130712|NCT01856426|"~     The purpose of this study is, to assess whether EDP239 can reduce the HCV viral load in HCV~     gentotype-1 in chronically infected subjects and to further evaluate the safety profile of~     EDP239.~   "
130713|NCT01856413|"~     Patients who receive liver transplantation for hepatitis B virus (HBV) induced liver failure~     require longterm therapy to prevent HBV reinfection of the transplanted liver. The approved~     preventative treatment is a combination of antihepatitis B immunoglobulin (HBIg) and oral~     antiviral medication. In the first 6 months after liver transplantation, patients receive~     treatment with intravenous HBIg to maintain blood antihepatitis B (antiHBs)antibody~     concentrations above 100 IU/L, the level considered safe for preventing hepatitis B~     reinfection.~      Zutectra is an HBIg preparation for subcutaneous injection that is approved in the EU for the~     'prevention of HBV reinfection in HBV DNA negative patients ≥ 6 months after liver~     transplantation for hepatitis B induced liver failure'. The purpose of this study is to show~     that earlier subcutaneous HBIg treatment with Zutectra after liver transplantation can~     prevent hepatitis B reinfection.~      Treatment with subcutaneous HBIg (Zutectra) at home is manageable for the majority of~     patients and is more convenient for patients compared to intravenous treatment that must take~     place in the hospital setting.~      Fourty patients will take part in the study at approximately 19 centres in UK, France, Italy~     and Spain. Patients who are eligible for the study will receive treatment with Zutectra for~     24 weeks.~      During the study, the safety and effectiveness of Zutectra will be assessed by checking for~     symptoms of hepatitis B related infection, as well as monitoring blood levels of antiHBs~     antibodies and hepatitis B surface antigen (HBsAg).~   "
130714|NCT01856400|"~     There is a certain gene called sarcoplasmic reticulum gene (SERCA2a), which is found in heart~     muscle. This gene is also found in blood vessels and skin tissue. When active this gene~     builds a crucial protein inside the heart muscle called SERCA2a protein. This is responsible~     for regulating calcium levels inside your heart muscle. When this gene is not activated,~     studies have shown that it can lead to abnormal electrical currents in the heart that can~     lead to death. The investigators are conducting this study to prove that SERCA2a gene is~     inactive in patients with kidney disease. Scientists found that patient at risk for abnormal~     electrical currents in the heart can be tested by what they called microvolt Twave~     alternans. This is a very delicate machine much more sensitive than a regular~     electrocardiogram that you do at the cardiology office.~   "
130715|NCT01856387|"~     Neutrophil/lymphocyte ratio (NLR) is a marker of systemic inflammation and endothelial~     dysfunction. In recent years, it has been reported that the individual components of the~     differential white cell count, specifically the neutrophil and lymphocyte counts,may have~     clinical utility in predicting diseases. An elevated NLR has been shown to be a prognostic~     indicator in various malignancies. İn the literature, many studies have been shown that NLR~     have predictive value in determining the prognosis of various diseases (cardiac or noncardiac~     diseases ). However, little is known about the predictive values of NLR in pregnancy~     complications. This study aimed to evaluate the potential predictive value of NLR in~     preeclampsia- eclampsia.~   "
130716|NCT01856374|"~     This study is a prospective open-labeled, randomized study to compare the neointimal coverage~     at 3 months and 12 months and its serial changes between 3 months and 12 months according to~     the implanted DES and evaluate the serial changes in the proximal portions of 3 epicardial~     coronary artery and left main artery including the assessment of fibrous cap thickness and~     lipid pool for vulnerable plaques by OCT. In addition, the investigators will compare the~     changes such as plaques and neointimal coverage from serial OCT follow-up according to the~     different statin strategy.~   "
130717|NCT01856361|"~     This is a randomized controlled trial to evaluate the effect of ramipril in stimulating and~     promoting sperm production in men with low sperm count. Ramipril is an Angiotensin Converting~     Enzyme Inhibitor (ACEI) currently used to treat high blood pressure. However, previous~     studies have shown that this class of medications can improve sperm parameters. The purpose~     of this study is to evaluate the efficacy of ramipril compared to placebo (Substance That is~     not known to have treatment effect), in improving sperm density in infertile men with~     documented low sperm count. This study will help us identify subjects that might benefit from~     treatment with this medication, and the effect it will have on sperm count, shape, and~     motility.~   "
130718|NCT01856348|"~     The study is conducted to assess the effect of a vitamin D3 supplementation on the activities~     of two intestinal transporters and on the pharmacokinetics of the transporter substrates~     folic acid and fexofenadine.~        -  Trial with medicinal product~   "
130728|NCT01856218|"~     UX003-CL201 is an open-label Phase 1/2 study to assess the safety, efficacy, and dose of~     UX003 in MPS 7 patients via intravenous (IV) administration every other week (QOW) for 36~     weeks with up to an additional 36 weeks from the optional continuation period. Up to 5~     participants, who are between 5 and 30 years of age inclusive, will be enrolled and treated~     with UX003.~      The initial 12-week treatment period will be followed by a 24-week forced dose titration~     period to assess the optimal dose. Participants who complete both the initial treatment and~     forced dose titration periods will continue treatment in a 36- week continuation period.~   "
131167|NCT01850472|"~     The purpose of this research study is to investigate how the brain processes emotions, and~     the way these processes affect behavior. Specifically, we hypothesize that individual~     differences in reward responsiveness will correlate with differential activation in~     mesolimbic regions of the brain and predict future wellbeing in follow-up interviews.~   "
130719|NCT01856335|"~     Study Population~      -People with seizures benefit from regular exercise. Exercise may help decrease the number of~     seizures they have. It also improves overall health and quality of life. However, people with~     seizure disorders often have been prevented from doing sports or other regular physical~     activity. They may also feel that exercise or injury can increase their risk of seizures.~     Researchers want to try an exercise program for people who have seizures to see if they can~     increase motivation to exercise which will improve overall health and may decrease the~     frequency of seizures.~      Objectives:~      - To see how exercise education improves motivation to exercise in people who have a history~     of seizures.~      Eligibility:~      - Individuals at least 18 years of age who have a history of seizures.~      Design:~        -  This study involves three outpatient visits and weekly telephone calls for about 12~          weeks. There will be followup calls at about 6 and 12 months after the outpatient~          visits.~        -  Participants will be screened with a physical exam and medical history. They will answer~          questions about their current level of physical activity, mood, quality of life, and~          ideas about exercise.~        -  At the first visit, participants will learn how to keep a physical activity log and~          seizure calendar. They will also use an activity monitor and take their pulse regularly.~          They will complete questionnaires about their mood and thoughts about exercise and~          seizures.~        -  At the second visit, participants will set personal activity goals and learn about~          physical activity and seizures. They will review the physical activity log, seizure log,~          and activity monitor and pulse readings for the previous 4 weeks.~        -  After the second visit, participants will receive weekly telephone calls. Each call will~          last about 5 minutes. These calls will ask about physical activities for the week and~          participants' progress toward meeting their goals. These calls will also review the~          seizure log.~        -  At the third visit (12 weeks), the same tests from the first visit will be repeated.~        -  The followup phone calls will continue to monitor participants' activity levels.~   "
130720|NCT01856322|"~     Background:~      - Some types of inflammation may increase the risk of cancers in the intestinal track.~     Because of this possibility, anti-inflammatory drugs may be able to prevent tumor growth and~     spread. One such drug, sulindac, may be helpful to study. Researchers want to see if people~     who are having surgery to remove intestinal tumors from advanced colorectal cancer will~     benefit from sulindac. It will be tested against a placebo.~      Objectives:~      - To see if sulindac can improve treatment outcomes in people who are having surgery for~     advanced colorectal cancer.~      Eligibility:~      - Individuals at least 18 years of age who are having surgery for advanced colorectal cancer.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood samples~          will be collected. Imaging studies and heart and lung function tests may also be given.~        -  Participants will be separated into two groups. One group will take sulindac. The other~          will take a placebo.~        -  Participants will take sulindac or placebo twice daily from about 2 to 3 weeks before~          the scheduled surgery. Seven days before the surgery, they will stop taking the pills.~        -  Participants will have surgery to remove their tumors. The surgery will also remove~          affected organ tissue.~        -  Participants will start to take the pills again once they have recovered from surgery.~          They will continue taking the sulindac or placebo twice a day for 3 years, or for as~          long as the tumors do not return.~   "
130721|NCT01856309|"~     The purpose of this study is to evaluate the long-term safety and efficacy of CNTO 136~     (sirukumab) in participants with rheumatoid arthritis (RA) who are unresponsive to treatment~     with modifying antirheumatic drugs (DMARDs) or anti-TNF alpha agents.~   "
130722|NCT01856296|"~     An open non-randomized study using biology driven selection of therapies. WINTHER study will~     explore matched tumoral and normal tissue biopsies and will use a novel method for predicting~     efficacy of drugs. The aim is to provide a rational personalized therapeutic choice to all~     (100 %) patients enrolled in the study, harboring oncogenic events (mutations/~     translocations/ amplifications, etc.) or not. The total number of patients treated in the~     study will be two hundred across all participating cancer centers (European countries~     -France; Spain-, Israel, USA and Canada). All centers will realize the same study~     independently.~   "
130723|NCT01856283|"~     This is a multicentre, single-arm study of nilotinib 300 mg BID in newly diagnosed patients~     with CP-CML. This study is designed to establish the disappearance of Ph+ stem cells~     (CD34+/lin-) in BM during nilotinib treatment.~      In addition, in this study the investigators aim to perform Gene Expression Profiling (GEP)~     of CML enrolled patients using Affymetrix GeneChip Instruments and Software Systems, and~     Affymetrix GeneChip Human Genome U133 Plus 2.0 (whole human transcriptome analysis) at~     diagnosis and at 3 different time points during treatment with Nilotinib (after 3, 6, 12~     months).~   "
130724|NCT01856270|"~     The investigators propose to conduct a 2-arm, open-label pilot study to determine if early~     treatment with amitriptyline will decrease the frequency and severity of headaches after mild~     traumatic brain injury (TBI). Amitriptyline is a tricyclic antidepressant that is commonly~     available and inexpensive. It is used as a first-line drug for primary headache prevention in~     a very low dose range of 10-50 mg.~        -  Specific Aim 1 is to conduct a 2-arm open-label study to examine the effect of~          preventive treatment with amitriptyline on the frequency and severity of headache after~          mild TBI.~        -  Specific Aim 2 is to collect data needed for design of a Phase 3 study, including an~          estimate of effect size, headache variability, and desirable drug treatment start date.~        -  Specific Aim 3 is to examine the feasibility of using headache diaries with individuals~          with mild TBI.~        -  Specific Aim 4 is to establish the safety and tolerability of amitriptyline for the~          prevention of headache after mild TBI.~      The investigators hypothesize that early preventive treatment with amitriptyline will avert~     the development of chronic post-traumatic headache (PTH) as compared to rates of headache~     from a recent natural history study on PTH after mild TBI.~      The investigators propose to enroll inpatient subjects from a Level I trauma center as well~     as from outpatient clinics and from the general community with a diagnosis of mild TBI.~     Subjects will be screened for current headache. After baseline assessment, 72 subjects with~     current headache will be randomized to one of 2 groups. Group 1 will immediately begin~     amitriptyline and or Group 2 will be followed and begin amitriptyline at Day 30. All subjects~     will be asked to complete a daily headache diary beginning on Day 1 of the study. A detailed~     medical history and headache survey will be completed. Subjects will have a scheduled stepped~     increase in the drug dosage every week for 3 weeks to the maximum study dosage of 50 mg.~     Weekly telephone calls will monitor for adverse events and compliance with the drug and~     headache diary. Clinic visits will occur at 30, 60 and 90 days. The 30 day clinic visit will~     include cognitive testing to assess for differences between groups and initiation of drug~     treatment for Group 2. Both 30 and 60 day visits will include review of headache diary,~     potential adverse effects, and pill counts. The 90 day visit will be for outcome assessment.~     In addition, the headache survey will be repeated by telephone at Day 180.~   "
130725|NCT01856257|"~     The primary objective is to evaluate a NULOJIX® (belatacept) based regimens as a means of~     improving long-term graft function without increasing the risks of immunologic graft injury~     by avoiding both calcineurin inhibitors (CNIs) and corticosteroids.~   "
130726|NCT01856244|"~     Persons with Morbus Parkinson commonly develop gait and balance disorders leading to~     dependence, loss of mobility and a high risk of falling.~      This study investigates the effectiveness of a sensorimotor treadmill intervention to improve~     walking and balance abilities in persons with early stages of Parkinson's disease. The~     sensorimotor treadmill training is conducted on a special treadmill device which is~     challenging the participants by small oscillations. This intervention, which is supposed to~     simulate walking on natural, uneven surfaces, is compared to a conventional treadmill~     training.~      Hypothesis: Sensorimotor treadmill training leads to larger improvements in walking and~     balance abilities as compared to conventional treadmill exercise.~   "
130765|NCT01855737|"~     1. Title: Clinical study of the relationship between Pharmacogenomics and warfarin dose in~          Chinese patients~        2. Drug: Warfarin~        3. Design: To value the accuracy of warfarin Pharmacogenomics algorithm by the algorithm~          calculated dose and actual dose in the Chinese patients.~        4. Hypothesis:Pharmacogenomic algorithm guided dose can help to predict warfarin dose in~          Chinese patients.~   "
130729|NCT01856205|"~     Japanese encephalitis is caused by a viral infection of the brain transmitted by the bite of~     an infected mosquito. Patients with Japanese encephalitis can rapidly develop worsening~     conscious level and seizures. Around a third will die from the infection and half of~     survivors have serious long-term neurological disability. The majority of those affected are~     children. There are many causes of viral encephalitis, however Japanese encephalitis virus is~     the most common cause worldwide with over 60,000 cases annually. It occurs over much of Asia~     and the geographical range is expanding. There is no specific treatment for Japanese~     encephalitis virus, although several have been trialed. In this study we examined the effect~     of a new treatment, called intravenous immunoglobulin, on children with Japanese encephalitis~     in Nepal. Prior studies have suggested intravenous immunoglobulin may neutralize Japanese~     encephalitis virus and suppress damaging inflammation in the brain. It has previously been~     used in individual cases but never examined in a randomized trial. There was recently a trial~     of IVIG in West Nile encephalitis in the United States, in which Professor Solomon was on the~     Scientific Advisory Committee. In this study we will look if intravenous immunoglobulin is~     safe in this context, and that this treatment may alter the way the immune system manages the~     infection. Therefore, in this pilot study we will test the hypothesis that IVIG can be safely~     given to children with suspected JE, with no increased risk of serious adverse events~     compared with placebo. The aim of this proposal is to conduct a pilot safety and tolerability~     randomized placebo controlled trial of intravenous immunoglobulin (IVIG) in patients with~     Japanese encephalitis, to explore the relationship between JEV viral load, pro-inflammatory~     markers called cytokines and blood brain barrier markers, and the effect of IVIG on these~     relationships.~   "
130730|NCT01856192|"~     This randomized phase II trial studies how well rituximab and combination chemotherapy with~     or without lenalidomide work in treating patients with newly diagnosed stage II-IV diffuse~     large B cell lymphoma. Monoclonal antibodies, such as rituximab, may interfere with the~     ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as~     cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in~     different ways to stop the growth of cancer cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Lenalidomide may stimulate the immune~     system in different ways and stop cancer cells from growing. It is not yet known whether~     rituximab and combination chemotherapy are more effective when given with or without~     lenalidomide in treating patients with diffuse large B cell lymphoma.~   "
130731|NCT01856179|"~     The objective of this study is to investigate the conversion of the precursors ALA and SDA~     into n-3 LC-PUFA (EPA, DPA and DHA) in humans by oral supplementation of Echium oil in~     comparison with SDA soybean oil (positive control). In addition, the accumulation of n-3~     LC-PUFA is compared between subpopulations of different age, gender and physiological~     conditions (overweight, increased serum total cholesterol).~   "
130732|NCT01856166|"~     Epidural analgesia still have an impact on obstetric outcomes and especially on instrumented~     delivery rates.~      To assess the best maintainance regimen of epidural analgesia during labor the investigators~     plan to include 300 nulliparous in this multicenter randomized, double blind trial. The~     primary outcome will be a composite set of criteria that can lead to instrumented delivery.~     Secondary outcome will focus on analgesia motor block and satisfaction.~   "
130733|NCT01856153|"~     Primary objective is to determine if the efficacy of strawberries delivering polyphenols to~     prevent metabolic inflammation will be influenced by timing of consumption relative to meal~     intake.~      Secondary objective is to characterize the relative bioavailability and absorption profile of~     strawberry polyphenols consumed with meal or at alternatives times around a meal (2 hours~     before the meal ad 2 hours after the meal).~      Third objective is to determine the bioavailability/absorption profile of strawberry~     polyphenols and its relationship with the anti-inflammatory mechanism of action of strawberry~     constituents.~   "
130734|NCT01856140|"~     Main purpose of this study is to evaluate efficacy and safety of allogenic adipose-derived~     mesenchymal stem cells(ALLO-ASC) in treatment of tendon injury. ALLO-ASC will be~     administrated to the patients with lateral epicondylitis by ultrasonographic guided~     injection.~   "
130735|NCT01856127|"~     This is a three-center, randomized, double-blind, fixed dose study designed to assess the~     efficacy, safety, and tolerability of a switch to vilazodone for sexual dysfunction~     associated with use of a selective serotonin reuptake inhibitor (SSRI) and~     serotonin-norepinephrine reuptake inhibitor (SNRI)compared to switching to sertraline in~     patients with Major Depressive Disorder (MDD).~      Vilazodone is a newly introduced, FDA approved antidepressant that is a combined serotonin~     specific reuptake inhibitor and serotonin 1A receptor partial agonist. In contrast to the~     SSRIs and SNRIs, appears to have low adverse effects on sexual functioning when compared to~     placebo.~   "
130736|NCT01856114|"~     The goal of this clinical research study is to learn if fentanyl can change perception of~     shortness of breath in cancer patients. Researchers also want to learn if the study drug can~     help to improve your physical function. In this study, fentanyl will be compared to a~     placebo.~      Fentanyl is commonly used for treatment of cancer pain.~      A placebo is not a drug. It looks like the study drug but is not designed to treat any~     disease or illness. It is designed to be compared with a study drug to learn if the study~     drug has any real effect.~   "
130737|NCT01856101|"~     The mTOR (mammalian Target of Rapamycin) protein is the center of the mTOR pathway that plays~     an important role in cell growth, proliferation, survival and angiogenesis through sensing~     and integrating energetic signals from cellular environment. The mTOR protein is composed of~     two complex, mTOR complex 1 (mTOR C1) and mTOR complex 2 (mTOR C2).~      In regards of mTOR pathway dysregulations observed in TCC development, there is a rational to~     test BEZ23 in advanced TCC. BEZ235 is a pan-class I PI3K inhibitor that, in addition, binds~     to the catalytic site of mTOR, inhibiting mTOR C1 and mTOR C2.~   "
130738|NCT01856088|"~     The main objective of this study is to evaluate the effectiveness of stent Inspiron ™~     sirolimus-eluting and coating the abluminal biodegradable stent Biomatrix Flex ™ lesions in~     native coronary arteries.~   "
130739|NCT01856075|"~     This is an international observational multicentre study to be conducted in Germany, Spain,~     Italy and USA. The main objective of the study is to evaluate the relative effectiveness of~     dronedarone in real world clinical practice versus other anti-arrhythmic agents of interest.~     The design of the study is a historic-prospective cohort with dynamic exposure and stratified~     competitive recruitment with balanced comparison groups of dronedarone versus alternative~     antiarrhythmic drugs of interest.~   "
130740|NCT01856062|"~     The purpose of this study is to determine if the addition of dexamethasone to clomiphene~     citrate will increase the pregnancy rate of intrauterine insemination (IUI) cycles.~   "
130766|NCT01855724|"~     The purpose of this study is to determine whether gemcitabine and pazopanib are effective in~     the treatment of inoperable, locally advanced or metastatic biliary tree cancer~     (cholangiocarcinoma or gallbladder carcinoma).~   "
130741|NCT01856049|"~     Cell-based cardiac regeneration has been the focus of acquired, adult heart disease for many~     years. However, congenital heart disease with severe structural abnormalities may also be~     reasonable targets for cell-based therapies. Interestingly, the pediatric heart is naturally~     growing and may be the most amendable to regenerative strategies. Therefore, identifying~     autologous cells (cells from the patient's own body) would be important to initiate these~     studies.~      This study aims to validate the use of umbilical cord blood as a source of autologous cells~     for the purpose of cardiac repair of congenital heart disease. Cells will be isolated from~     the cord blood to help us determine the feasibility of collection, processing, and storage of~     these samples at the time of birth of infants with prenatal diagnosis of hypoplastic left~     heart syndrome. This study may be useful for the development of pre-clinical and clinical~     studies aimed at the long-term goal of repairing damaged heart muscle.~   "
130742|NCT01856036|"~     This protocol will study the impact of cryoablation on immune response in patients diagnosed~     with invasive breast cancers smaller than 1.5 cm. It will profile the immune response to~     cryoablation of invasive breast cancers. The intra-tumoral and systemic immune response to~     cryoablation will be determined and compared to pre-ablated breast cancer specimens and~     historical control specimens.~   "
130743|NCT01856023|"~     Phase IV, open-label, randomized, two-arm, multi-center study in patients with metastatic~     melanoma who are treatment naïve or have previously received a single non-immunologic~     therapy.~      Treatment Arm 1: Patients will receive two courses (four cycles) of High Dose Interleukin-2~     (HD IL-2) followed by one course (four doses) of ipilimumab.~      Treatment Arm 2: Patients will receive one course (four doses) of ipilimumab followed by two~     courses (four cycles) of HD IL-2.~      HD IL-2 and ipilimumab dosing regimens will comply with the instructions in the most current~     package inserts, institutional guidelines, and medical expertise of the treating physician.~     However, neither the ipilimumab nor the HD IL-2 should be dose reduced. If necessary, doses~     should be either held or permanently discontinued (per package insert instructions). Protocol~     specific dosing guidance is included in the 12PLK02 Work Instructions.~      Patients will be scheduled for four response assessments. Response assessment timing should~     be targeted to fall within the following time points: between 5-11 weeks, 13-19 weeks, 24-30~     weeks and one year after initiating therapy in either treatment arm. Timing of the response~     assessments may be adjusted to facilitate clinical procedures and treatment decisions.~      Patient treatment tolerability and safety events will be monitored and managed while enrolled~     in the 12PLK02 study. Patients who receive HD IL-2 in the 12PLK02 study will be enrolled in~     the PROCLAIM study (Registry Protocol 10PLK13) for the collection of long-term assessment~     data, including response and disease status and treatment decisions. Patient treatment data~     will be entered in to the PROCLAIM database, for a minimum target of 2 years and potentially~     up to 5 years, after the patient completes the 12PLK02 study.~   "
130744|NCT01856010|"~     Agitation/aggression is one of the most common and serious behavioral complications of~     dementia. If the behavior is refractory to standard care (behavior approaches and off label~     use of psychotropic medications), other evidence based treatment options are not currently~     available. Retrospective reviews and preliminary studies have indicated Electroconvulsive~     Therapy (ECT) may be a safe, effective intervention in this patient population. This study~     will measure the impact of open-label ECT on symptoms of agitation, aggression, cognition,~     mood and psychosis for patients referred for ECT who accept this intervention vs. those~     patients referred for ECT but decline this intervention (i.e. standard care controls). It~     will also assess adverse events, activities of daily living and caregiver burden during study~     participation. The hypothesis is that subjects with dementia related aggression/agitation who~     receive ECT will show significantly greater reductions in these behaviors than subjects who~     do not consent for ECT and continue with standard care. Pine Rest is partnering with McLean~     Hospital (Massachusetts) to answer this question. To our knowledge, this is the first~     prospective study to examine whether patients receiving ECT or standard care differ in~     reduction of aggression and agitation symptom severity and changes in cognition pre- and~     post- treatment.~   "
130745|NCT01855997|"~     This Phase 4 study is designed for the collection of blood biomarker samples from~     participants who have completed CHB treatment with at least 24 weeks of a pegylated~     interferon alfa-2a (Peg-IFN alfa-2a) containing regimen and at least 24 weeks post-treatment~     follow-up. Participants may be enrolled from historical studies supported or sponsored by~     Roche, ongoing studies supported or sponsored by Roche, or from general medical practice. The~     follow-up of individuals who choose to participate in this study will be in accordance with~     the ongoing studies or with the general medical practice of the physician. Data from whole~     blood deoxyribonucleic acid (DNA) samples collected in the GV28555 study or available from~     previously collected Roche Clinical Repository (RCR) samples will be used for combined~     analysis with data from other applicable studies. Procedures will include blood sample~     collection (not applicable for participants who previously have consented and donated RCR DNA~     samples) and medical record capture.~   "
130746|NCT01855984|"~     The purpose of this study is to determine if tocotrienol supplementation given to school~     going children with ADHD will result in reduction of their ADHD symptoms.~   "
130747|NCT01855971|"~     Fragile X syndrome (FXS) present alterations in synaptic plasticity that produce intellectual~     disability. can produce improvement. Estrogens (targeting Estrogen Receptors beta (ER-β) can~     act as neuroprotective agents, promoting synaptic plasticity and neurite outgrowth, and~     health benefits derived from flavonoids, as the flavonol epigallocatechin gallate (EGCG),~     phytoestrogens of natural origin are partially explained by their interaction with membrane~     ER. Selective ER-β flavonoids are thus good candidates for their therapeutic evaluation in~     intellectual disabilities. EGCG also targets central intracellular transduction signals~     altered in FXS and improves memory recognition in a FXS animal model(adenosine triphosphate~     (ATP)-inhibitor of phosphatidylinositol 3-kinase (PI3K)and mammalian target of rapamycin~     (mTOR) and extracellular signal-regulated kinase (ERK1/2). This study targets the synaptic~     plasticity alterations that underlie the learning and memory impairment but also the~     computational disability in FXS. The hypothesis is that EGCG can act by favoring the~     physiological processes involved in cognition.~   "
130767|NCT01855711|"~     This study is an exploratory study aiming (i) to obtain clinical experience of GR68755 in~     Japanese subjects with severe d-IBS to explore the feasibility of the next phase study and~     (ii) to obtain reference data for endpoints and dosage and administration of a next phase~     study.~   "
130748|NCT01855958|"~     The aim of this study is to evaluate the cortical excitability in pain of knee osteoarthritis~     (OA), as well as the effect of one session of a kind of electroacupuncture (deep needling~     intramuscular stimulation therapy - DIMST) in this pain and the cortical excitability after~     the intervention.~      The hypothesis is that cortical excitability is altered in this condition, confirming the~     findings already described in other chronic pain conditions. The investigators also believe~     that a session DIMST can reduce pain and alter cortical excitability, restoring its previous~     activity will occur from chronic pain.~   "
130749|NCT01855945|"~     Evaluate the safety and immunogenicity of three dosage levels of swine influenza vaccine in~     children ages 3 to <9 years, adolescents 9 to <18 years, adults 18 to <65 years and elderly~     65 years and older.~   "
130750|NCT01855932|"~     The Enlighten study is an 8-week trial investigating the response to use of a smartphone diet~     and activity application. Participants are enrolled as part of a worksite intervention, and~     will receive the LoseIt! weight loss smartphone application, which requires participants to~     self-monitor dietary intake and physical activity, a component shown to effectively produce~     weight loss. The application will be programmed to deliver dietary intake recommendations~     during the first three weeks of the intervention. At the 3 week time point, self-monitoring~     adherence via the smartphone application will be assessed and those who are not responding~     will receive 4 weekly telephone coaching sessions. Those individuals who respond at the end~     of 3 weeks will be encouraged to continue self-monitoring on the application. All~     participants will also receive regular text messages throughout the trial. The importance of~     the proposed research lies in the objective to reconfigure weight loss treatment so as to~     achieve the intended outcome more efficiently and in a manner that allows greater reach.~   "
130751|NCT01855919|"~     The purpose of the study is to assess the efficacy and safety of duloxetine in participants~     with Chronic Low Back Pain (CLBP).~   "
130752|NCT01855906|"~     The purpose of this study is to examine the impact of two surgical techniques on the outcome~     of the knee replacement surgery.~   "
130753|NCT01855893|"~     The purpose of this study is to evaluate the effectiveness of the auto-acupressure (digital~     pressure in points of acupuncture) added to the conventional treatment.~   "
130754|NCT01855880|"~     This is a Phase IIa, randomised, double-blind, placebo-controlled, multiple dose,~     multi-center study of AbGn-168H in subjects with moderate to severe chronic plaque~     psoriasis.The objectives of this study is to investigate efficacy, safety, tolerability, and~     pharmacokinetics (PK) of multiple doses of AbGn-168H administered intravenously to patients~     with moderate to severe chronic plaque psoriasis.~   "
130755|NCT01855867|"~     The purpose of this study is to see if an anti-HIV medication known as Stribild~     (elvitegravir/cobicistat/emtricitabine/tenofovir DF) is safe, tolerable and acceptable when~     taken for 28 days, once a day after a possible, sexual, exposure to the Human Immune~     Deficiency Virus (HIV).~   "
130756|NCT01855854|"~     This study is designed to evaluate the efficacy and safety of icotinib in treating advanced~     carcinoma of the gastroesophageal junction and esophagus with EGFR overexpression (IHC 3+) or~     positive FISH, the primary endpoint is objective response rates.~   "
130757|NCT01855841|"~     ERCP (endoscopic retrograde cholangiopancreatography) has been largely demonstrated to be~     effective in multiple bilio-pancreatic indications. However, one of the feared complication~     of this technique is acute pancreatitis, which happens in 5 to 25% of cases. Some patient~     groups have been demonstrated to present a higher risk linked to individual factors or to the~     procedure. Some interventions (endoscopic or pharmacologic) have been evaluated to reduce the~     incidence of this complication but each has his own inconvenient. Recently, the activation of~     heme oxygenase (HO) by intraperitoneal administration of hemin has been demonstrated to be~     effective in prevention and treatment of acute pancreatitis mice models. This protective~     effect has been associated to intrapancreatic HO-1 positive macrophage recruitment activated~     by hemin. The investigators thus propose to conduct a prospective randomized double blind~     controlled trial to demonstrate a protective effect of hemin administration against post-ERCP~     acute pancreatitis in high risk patients.~   "
130758|NCT01855828|"~     The main goal of this clinical trial is to test if adding pertuzumab (Perjeta), improves the~     anticancer activity of the combination chemotherapy regimen of trastuzumab (Herceptin)~     concomitant with paclitaxel, 5-fluorouracil, epirubicin, and cyclophosphamide (T-FEC). The~     study will also test the safety of this therapy.~   "
130759|NCT01855815|"~     The purpose of the Hemolung RAS Registry Program is to collect retrospective, de-identified,~     standard of care data following the commercial use of the Hemolung RAS.~   "
130760|NCT01855802|"~     This attempts to investigate the perceptions of Greek Ophthalmologists regarding generics~     prescription in glaucoma by means of a structured questionnaire.~   "
130761|NCT01855789|"~     This randomized, multicenter, double-blind, parallel group study will evaluate the impact of~     MTX discontinuation on the efficacy of SC TCZ in participants with moderate to severe active~     rheumatoid arthritis who have an inadequate response to current MTX therapy. Participants~     will initiate treatment with TCZ weekly or every 2 weeks along with MTX at a stable dose~     orally in an open-label manner for 24 weeks. Participants with a disease activity score based~     on 28 joints (DAS28) less than or equal to (</=) 3.2 at Week 24, will be randomized to either~     continue receiving a stable dose of MTX or to switch to matching placebo up to Week 52.~     Participants without a DAS28 score </=3.2 at Week 24, will continue the same treatment in a~     non-randomized open-label manner up to Week 52.~   "
130762|NCT01855776|"~     This study aims to assess the uptake, effectiveness, and cost-effectiveness of a scalable~     walking programme for full-time employees both with and without incentives.~   "
130763|NCT01855763|"~     The study hypothesis was In women with gestational diabetes and type 2 diabetes in pregnancy~     metformin treatment compared with insulin will result in better perinatal and maternal~     outcome and improved treatment acceptability with low or noadditional insulin requirement.~   "
130764|NCT01855750|"~     The purpose of this study is to evaluate if ibrutinib administered in combination with~     rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) improves the~     clinical outcome in newly diagnosed patients with non-germinal center B-cell subtype (GCB) of~     diffuse large B-cell lymphoma (DLBCL) selected by immunohistochemistry (IHC) or newly~     diagnosed patients with activated B cell-like (ABC) subtype of DLBCL identified by gene~     expression profiling (GEP) or both populations.~   "
130768|NCT01855698|"~     The primary objective of the study is to assess efficacy and safety of different prophylactic~     or therapeutic antithrombotic approaches in patients with hematologic neoplasms and platelet~     count <50 x109/L, including unfractionated or low molecular weight heparin, fondaparinux,~     anti-vitamin K agents, antiplatelet agents, novel oral anticoagulants, fibrinolytic agents,~     with or without a policy of platelet transfusion. Cases with arterial or venous~     thromboembolism managed with observation or use of vena cava filters in patients with venous~     thromboembolism will be included too.~   "
130769|NCT01855685|"~     X-linked chronic granulomatous disease (X-CGD) is a rare genetic disorder, which affects~     boys. It is caused by an error in a gene that makes part of the immune system. The basic~     defect lies in specialised white blood cells called phagocytic cells (or phagocytes), which~     are responsible for protection against infection by destroying invading bacteria and fungi.~     They do this by pouring large amounts of substances similar to bleach onto these organisms.~     In CGD, there is a defect in the system that makes the bleach, called the NADPH-oxidase. In~     X-CGD (which accounts for two thirds of patients), the defect lies in a gene which makes up a~     critical part of the NADPH-oxidase (known as gp91-phox), and the cells cannot make~     bleach-like substances. Therefore they kill bacteria and fungi poorly, and the patients~     suffer from severe and recurrent infections. This also results in inflammation which can~     damage parts of the body such as the lung and gut.~      In many cases, patients can be adequately protected from infection by constant intake of~     antibiotics. However, in others, severe life-threatening infections break through. In some~     cases, inflammation in the bowel or urinary systems results in blockages which cannot be~     treated with antibiotics, and which may require the use of other drugs such as steroids.~     Development of curative treatments for CGD is therefore of great importance.~   "
130770|NCT01855672|"~     The objective of this proof-of-concept study is to generate initial safety and effectiveness~     data for the neuro-modulation stimulation (NMS) E-Box in patients with chronic migraine in an~     acute setting. The results of this study will determine if further development of this device~     in a larger study is warranted.~   "
130771|NCT01855659|"~     Peak Inspiratory Flow Rate (PIFR) is defined by the fastest flow rate noted during the~     inspiratory cycle.~      Inhaled medication plays an important role in the treatment of chronic obstructive pulmonary~     disease (COPD), with dry powder inhalers (DPIs) increasingly replacing metered dose inhalers~     (MDIs). DPIs are interesting as they do not require the need for coordinate actuation of the~     MDI device with inhalation or the use of a large spacer device 1-3. Several DPIs are~     available for the administration of inhaled corticosteroids, as well as bronchodilators, with~     each of them corresponding to a different type of inhaler (e.g. Diskus®, Turbuhaler®,~     Aeroliser®, etc.). During the inspiratory effort the patient generates a pressure drop with a~     consequent airflow across the DPI. This inspiratory flow has to be high enough to~     disaggregate and adequately disperse the drug powder into an aerosol cloud of drug particles~     and to guarantee an optimal deposition of the medication in the lung. Such peak inspiratory~     flows (PIFs) are not only dependent on a patient's inhalation effort but also on the internal~     resistance of the device.~      It has been shown that optimal deposition of medication with DPIs is not achieved in some~     patients with low inspiratory flow rates, such as children or patients with COPD, especially~     during acute exacerbations. In such conditions the use of a DPI with low internal resistance~     has been suggested, ensuring an optimal deposition despite the lower flow rate. In addition,~     many clinicians are nowadays confronted with an important number of COPD patients who are~     aged >70 yrs~   "
130772|NCT01855646|"~     The overall aim of this project is to improve the quality of the handoffs between~     hospitalists on the general medicine service at Durham Regional Hospital with the intent of~     improving transitions of care. The intervention will be an improved and more structured face~     to face sign-out process using a standardized admission sign-out sheet, which is not part of~     the official medical record. Daytime admitting physicians will assign an acuity score to~     their patients in which the severity of illness will be scored from 1-7, with 7 being the~     most sick / likely to have rapid response team (RRT) or adverse event. The assignment of this~     score would be based off of the clinician's judgment in the patient's overall assessment. All~     patients, age >18 years, admitted to the non-resident hospital medicine general medicine~     service at DRH will be study eligible. Data analysis will examine aggregate hospitalist~     perception of sign-out practice before and after intervention, total number of RRTs,~     unplanned transfers, and rapid responses pre and post intervention, percentage of hospitalist~     based patients of overall rapid responses pre and post intervention, percentage of~     hospitalists using acuity scores, and average and mean severity score of patients with rapid~     responses compared with those admitted. Patients have a risk of loss of confidentiality.~   "
130773|NCT01855633|"~     Stroke is one of the major causes of death in the World. Many stroke survivors may suffer~     from long-term sequelae of stroke such as hemiplegia. The effects of rehabilitation therapy~     are limited. The development of new treatment strategies is essential. Repetitive~     transcranial magnetic stimulation (rTMS) is a non-invasive method to stimulate the focal area~     of the brain for restoring brain function. The aim of this study is to investigate the~     therapeutic effect of rTMS on the motor recovery in patients with hemiplegic stroke.~   "
130774|NCT01855620|"~     Two-thirds of young women in the United States are overweight or obese. This excess weight~     may affect how their body metabolizes drugs such as different birth control methods. There is~     a not a lot of research about how excess weight could affect the hormone levels of the~     contraceptive implant. Methods like the implant contain only progesterone, which is a hormone~     that does not increase a woman's risk of blood clot. These methods would be preferred for~     overweight and obese women because excess weight also increases a woman's risk of blood clot.~      The investigators propose a study comparing blood hormone levels of women using the implant~     for at least twelve months and in all weight categories. The investigators hope to show that~     all women, regardless of weight, will have hormone levels high enough to prevent pregnancy.~   "
130775|NCT01855607|"~     To assess whether six week treatment with twice a day topical Menthol application will~     decrease persistent neuropathic pain from chemotherapy among breast and colorectal cancer~     patients.~   "
130776|NCT01855594|"~     To investigate the efficacy of lithium carbonate in the treatment of neuropathic pain of~     patients with spinal cord injury.~   "
130777|NCT01855581|"~     Sedation and anesthesia for diagnostic imaging represents a rapidly growing field of~     practice, especially in children. Propofol is the most common sedative drug administered for~     MRI/CT. However, this drug is associated with adverse events, including pulmonary~     complications, and there has been no report on these complications in Korea.~      The investigators reviewed 3739 charts of pediatric patients sedated for MRI/CT between~     January and November 2012.~      In this study, the investigators will report the nature and frequency of adverse events~     associated with sedation for MRI/CT between January and November 2012.~   "
130778|NCT01855568|"~     Ectopic pregnancy is an important cause of maternal morbidity and occasionally mortality.~     Deaths associated with ectopic pregnancy have declined, though approximately 75% of deaths in~     the first trimester and 9-13% of all pregnancy-related deaths are associated ectopic~     pregnancy. The main stays of management for ectopic pregnancy were surgery and medical~     treatment. Medical management with systemic methotrexate administration avoids the inherent~     morbidity of anesthesia and surgery is cost-effective, and also offers success rates~     comparable to surgical management, with no loss in future potential fertility.~      However, although medical management using methotrexate is used commonly, there is no solid~     consensus regarding dose protocol. Currently, there are three methotrexate protocols for the~     treatment of an ectopic pregnancy, multi-dose, single-dose, or two-dose. Among them,~     the multi-dose protocol includes the administration of 4 methotrexate doses alternating with~     leucovorin (rescue regimen). As a result of the multiple dosing of methotrexate, side effects~     are more common. In contrast, the advantages of the single-dose protocol include elimination~     of a rescue regimen, lower incidence of adverse effects, and better compliance. However, the~     single-dose protocol was found to be associated with a considerably lower success rate as~     compared with the multi-dose protocol (88% versus 93%) in a recent meta-analysis. The~     two-dose protocol, which it balances efficacy and safety/convenience, was described as a~     cross between the multi-dose and single-dose protocols.~      However, there were a few studies comparing between single-dose and two-dose protocol. The~     purpose of this prospective randomized trial was to compared the success rates of single-dose~     and two-dose methotrexate protocol for the treatment of tubal ectopic pregnancy.~   "
130779|NCT01855555|"~     Sedation and anesthesia for which to perform diagnostic imaging represents a rapidly growing~     field of practice, especially in children. Propofol is the most common sedative drug~     administered for MRI/CT. However, this drug is associated with adverse events, including~     pulmonary complications, and there has been no report on these complications in Korea. In~     this prospective observation study, the investigators will report the nature and frequency of~     adverse events associated with propofol-based sedation for MRI/CT.~   "
130780|NCT01855542|"~     Chloride-rich isotonic crystalloid solutions have been shown to exert electrolyte imbalance~     and metabolic acidosis in critically ill patients. The aim of this investigation is to~     compare the influence of 0.9% saline and plasmalyte solution on acid-base balance and~     electrolytes in healthy patients undergoing major spine surgeries.~   "
130781|NCT01855529|"~     After surgery for breast cancer, the prevalence of chronic pain is estimated between 20 and~     68%. They begin after surgery and may persist until more than 6 months. They respond poorly~     to opioid analgesics impair the quality of life.~      Among the different postoperative analgesic techniques used, the use of a local anesthetic~     infiltration continues catheter has advantages including improving the quality of analgesia,~     with a significant decrease in average of VAS (scale visual Analogue), a decrease in morphine~     consumption, improving the quality of life of patients.~      Our study aims to evaluate the effectiveness of a continuous local anesthetic infiltration in~     the control of postoperative pain after mastectomy.~   "
130782|NCT01855516|"~     This study is designed to assess: the incidence of abnormal partial thromboplastin time in~     patients receiving unfractionated heparin (UFH) 5000 U 2 times a day versus 3 times a day 72~     hours after administration of the first dose of heparin.~      Hypothesis: The basic hypothesis of this study is that patients receiving UFH 5000 U~     subcutaneously 3 times a day will have a higher proportion of elevated partial thromboplastin~     time than patients receiving UFH 5000 U subcutaneously twice a day.~   "
130783|NCT01855503|"~     This is a molecular testing study for patients with metastatic breast cancer. The purpose of~     this study is to find defects in the DNA of the cancer that could potentially be treated with~     US Food and Drug Administration (FDA)approved or investigational drugs. For example, if your~     cancer has a mutation in the Epidermal Growth Factor Receptor (EGFR) gene (a mutation is a~     change int he DNA sequence of a gene) that makes this receptor superactive a drug that~     inhibits this receptor may also inhibit the growth of the cancer. If this genetic defect is~     not present in the cancer the same drug may not work. This EGFR gene mutation based patient~     selection for treatment has worked in lung cancer and we are testing its value in breast~     cancer. What drugs may be available against particular genetic abnormalities in the context~     of this clinical study will change over time.~   "
130784|NCT01855490|"~     The study is designed as an open labeled pilot trial to analyze the acute responses of~     glucose, GLP-1, GIP, insulin secretory,and glucagon to a mixed meal tolerance test (MMTT) or~     intravenous glucose tolerance tests (IVGTT) with and without pretreatment with Exenatide~     (Byetta) 5 mcg sc.~      The investigators will also test the effects of Exenatide on gastric emptying during the~     MMTT.~   "
130808|NCT01855178|"~     Nocturnal seizure and Sudden unexplained death in epilepsy patients (SUDEP) are major~     concerns for parents and creates anxiety and poor sleep conditions for many families dealing~     with epilepsy. An accurate and reliable system for alerting parents to ongoing seizure~     activity could make a substantial impact in quality of life and possibly reduce the mortality~     of epilepsy. No previous studies in the pediatric population have been performed to evaluate~     this type of monitoring for seizure activity. This is one of the most common questions~     parents ask in clinic, Are there any alarms that can tell me when my child is having a~     seizure at night? Currently the answer is no. This study has the capability to give us data~     that may change this answer to yes.~   "
130809|NCT01855165|"~     Drug-drug interactions (DDIs) are common in patients with chronic heart failure (CHF) and~     their incidence increases with the number of drugs that the patients are prescribed for~     treatment of their condition. Data bases often detect DDIs that are of high clinical~     relevance. The investigators have performed this study in order to detect clinically~     significant DDIs and to diminish their occurrence by sending notification about DDIs to~     attending physician.~   "
130785|NCT01855477|"~     A major challenge for researchers in cancer care is to expedite the development of new~     therapeutics and the Center for Personalized Cancer Treatment (a collaboration of the Dept.~     of Medical Oncology from the University Medical Center Utrecht, Netherlands Cancer Center -~     Antoni van Leeuwenhoek hospital and the Erasmus Medical Center - Daniël den Hoed clinic) is~     an initiative to achieve this goal.~      The current and future generation anti-cancer drugs are developed to specifically activate or~     deactivate deregulated gene products or signaling pathways in cancer cells. The development~     of such targeted agents is an exciting new opportunity that promises to deliver more~     anti-cancer efficacy and less toxicity. Although targeted therapy has been a breakthrough in~     medical oncology leading to the development of a portfolio of potentially successful new~     drugs, it has not yet delivered the much needed relief for large patient populations. We~     believe that the development of these agents is mainly hampered by our lack of successful~     patient selection.~      The CPCT aims to select patients for clinical trial participation based on the results of~     Next Generation Sequencing (NGS) information obtained from tumor material. The advent of NGS~     platforms enables us to probe a significant proportion of the cancer genome and thus to~     develop a realistic view on the complex genetic changes in cancer cells. The CPCT aims to use~     NGS platforms to improve the selection of patients for targeted therapy trials.~      We will obtain tumor biopsies of a (preferably) metastatic or locally advanced lesion and~     peripheral blood sample from all patients included in the trial; the biopsies to obtain~     information on the tumor related genetic mutations (mutational profile) and the blood samples~     to assess each patient's germline DNA background variation. As patients will be asked to~     undergo an invasive procedure it is important to address the potential safety issues. Review~     of the literature shows that in general tumor biopsies can be performed with only minor~     complications and acceptable risks. We will recruit patients with metastatic or locally~     advanced (incurable) solid tumors and we aim to use the information obtained from DNA~     sequencing to stratify patients for inclusion in clinical trials. The final personalized~     treatment decision will be made dependent on the availability of trials and the expected~     predictive value of the mutational profile.~   "
130786|NCT01855464|"~     Primary spontaneous pneumothoraces (PSP) represent a significant public health problem,~     occurring in young healthy subjects without pre-existing lung disease or precedent medical~     intervention or trauma with a reported incidence of up to 18-28/100 000 per year. PSP~     treatment often requires thoracic surgery to restore lung expansion and to prevent de novo~     lung collapse. Despite the presence of elaborated guidelines by the British Thoracic Society~     (BTS) postulating apical wedge resection of the lung and total parietal pleurectomy (WRPP),~     the majority of German hospitals gathered experience especially in limiting surgery to~     cost-saving partial apical parietal pleurectomy or yet apical pleural abrasion (PP). Until~     today, hardly any reliable data exist to analyze and compare the varying treatment approaches~     regarding efficacy and efficiency. In this randomized, multi-centric clinical trial, both~     treatment approaches will be compared. For this purpose, candidates for surgery will be~     randomized into one of the two treatment groups after informed consent has been obtained.~     Patients will be followed for 2 years by the participating centres to be able to evaluate the~     long-term effect of the surgical interventions.~   "
130787|NCT01855451|"~     A standard treatment for patients with head and neck cancer is radiation given with high~     doses of a chemotherapy drug called cisplatin, given every 3 weeks during the radiation. This~     treatment is effective but can significantly increase side effects such as difficulty with~     swallowing, a sore mouth, fatigue, hearing loss, ringing in the ears and kidney failure. In~     Australia, a commonly used treatment HPV-Associated Oropharyngeal Squamous Cell Carcinoma is~     a lower dose of cisplatin given weekly during the radiation. The high dose and low dose~     schedules result in a similar total dose of cisplatin being given during the radiation, but~     it is thought that the weekly schedule results in fewer side effects while maintaining~     effectiveness.~      Another approach widely used around the world for patients with head and neck cancer, is to~     administer the antibody, cetuximab, weekly during radiation. Cetuximab has a very different~     side effect profile to cisplatin, and has been reported to result in less exacerbation of~     radiation related side effects. Both cetuximab and cisplatin can reduce the growth of a~     cancer and increase the effectiveness of radiation. Both cisplatin and cetuximab appear to be~     effective treatments in combination with radiation, but have not been directly compared.~      The purpose of this study is to compare the treatment related side effects (both acute and~     longer term) between the cisplatin and cetuximab regimens. Both treatments would be given~     with the same dose of radiation therapy over 7 weeks. The results of this trial will help~     determine the optimal treatment for patients with HPV-Associated Oropharyngeal Squamous Cell~     Carcinoma.~   "
130788|NCT01855438|"~     This study will test the efficacy of a communication intervention intended to increase and~     improve kidney transplant candidates' communication about live donor kidney transplantation.~   "
130789|NCT01855425|"~     The study objective is to compare the CBCT images generated by the CS 9300 to those generated~     by conventional CT. It proposes a direct comparison of diagnostic image quality between the~     CS 9300 and conventional CT using double image examinations.~   "
130790|NCT01855412|"~     The purpose of this study is to evaluate acute and long term clinical and economic outcomes~     of endovascular procedures to treat Peripheral Arterial Disease (PAD).~   "
130791|NCT01855399|"~     Peer support programs have been demonstrated to improve glycemic control among Veterans with~     poor control. This program will expand on this success by putting innovative tools in the~     hands of Veteran diabetes patients. Veteran coaches who have demonstrated effective control~     of their own diabetes will be trained to use communication skills to guide their peers~     through a diabetes education and decision aid. This tool, which is an iPad application, draws~     the patient in by showing them their personal risk and medication information derived from~     baseline labs and self-reported survey data. The tool encourages interaction by providing~     choices of materials to view, using audio-visual elements and incorporating a goal-setting~     process for developing self-management action steps and questions to discuss with their~     doctor at their next clinic visit. Ongoing weekly contact between the Veterans is supported~     by a confidential phone system.~   "
130792|NCT01855386|"~     The thought is that Non-Alcoholic Fatty Liver Disease (NAFLD) plays a key role in the~     progression to prediabetes/T2DM in those with a history of Gestational Diabetes (GDM). The~     investigators want to know if having a fatty liver will be connected with more glucose~     abnormalities (higher fasting/oral glucose tolerance test glucose, more insulin resistance)~     and that a history of GDM will be common in those with NAFLD.~   "
130793|NCT01855373|"~     To purpose of this study is to assess the effectiveness, safety and tolerability of PEAK ATP®~     with GlycoCarn®, PEAK ATP® and GlycoCarn® on levels of blood sugar and endothelial function~     improvement which may lead to improved vascular health.~   "
130794|NCT01855360|"~     The objective of the study is to determine whether the combination of the bile acid TUDCA,~     and doxycycline will slow the progression of familial and senile amyloidosis.~   "
130826|NCT01854944|"~     The purpose of this study is to determine how low and high does of brexpiprazole binds to~     certain receptors in the brain. This will be determined by PET scans taken pre-dose and~     post-dose.~   "
130795|NCT01855347|"~     There is an increasing incidence of Necrotizing Enterocolitis (NEC) affecting the premature~     infant population, principally those with associated risk like extreme prematurity, extreme~     low birth weight, associated co-morbidities (Congenital heart disease, perinatal asphyxia)~     and those born in hospitals with limited resources for optimal neonatal care.~      Near Infrared Spectroscopy (NIRS), has been used in premature infants to evaluate changes in~     cerebral perfusion and oxygenation. (1) It provides real time insight into the oxygen~     delivery.(3) In the premature patient population, many neurologic injuries occur as a result~     of prenatal (pre-existing) and/or postnatal disturbance on oxygen delivery. NIRS has been~     focused in cerebral monitoring. Light easily penetrates through neonatal bone and skin~     tissue, and allows to monitor the subjacent oxygen content. Early studies were performed to~     validate NIRS measurements and have established normative data.(4-6) The non-invasive method~     of monitoring cerebral hemodynamics and oxygenation has revolutionized the intensive care~     units in patients at risk for neurological injuries. This method has been successfully~     validated to monitor neonatal cerebral oxygenation in different clinical settings and study~     protocols. (7) NIRS provides non-invasive, continuous information on tissue perfusion and~     oxygen dynamics.~      One of the biggest challenges of NEC spectrum diseases is in the making of early diagnosis.~     It is important to monitor not just cerebral perfusion but also the intestinal~     oxygenation.(8,9) Previous studies with NIRS have demonstrated that premature infants change~     their cerebral - splanchnic oxygenation ratios during feedings.(10) Guy et al. performed NIRS~     in premature piglets to demonstrate association of perfusion change with NEC spectrum(11,12);~     these studies suggest evidence that NIRS could be a useful diagnostic tool in the premature~     infant population trough abdominal NIRS (a-NIRS) measurement capable of detecting alterations~     in intestinal oxygenation and perfusion.~      In summary, a-NIRS could be use in the premature infant population to define reference~     values, especially in patients at risk, which would then facilitate the early diagnosis of~     NEC spectrum diseases.~   "
130796|NCT01855334|"~     Cardiovascular disease is the primary cause of death in patients with end stage renal disease~     (ESRD). New research suggests that the high risk of death may be partly due to high levels of~     fibrosis and a loss of small blood vessels in the heart of patients with dialysis-dependent~     ESRD. This study is designed to compare the effects of two different drugs, spironolactone~     and L-arginine, with placebo on structure and function of the heart in individuals with~     dialysis-dependent ESRD.~   "
130797|NCT01855321|"~     This pilot study will investigate the effect of Vitamin D supplementation in improving~     glucose control with patients with poorly controlled diabetes and concurrent Vitamin D~     deficiency.~   "
130798|NCT01855308|"~     This is a study of new technology to allow gallbladder removal through a single small~     surgical incision. A surgical robot is utilized to help navigate the small space. In this~     study, patient characteristics are broad to assess how applicable the procedure is to~     everyone.~   "
130799|NCT01855295|"~     Poor nutritional status as evidenced by low body mass index, low muscle mass or low serum~     albumin is a strong predictor of morbidity and mortality in dialysis patients.~     Hypercatabolism induced by inflammation is widely considered the cause of uremic malnutrition~     even though there is no clear evidence that hemodialysis patients with elevated C-reactive~     protein (CRP) levels are at greater risk of losing weight or muscle mass. Conversely, there~     is little data on whether dialysis patients with malnutrition and elevated C-reactive protein~     levels would gain muscle mass with protein supplementation.~      The hypothesis is that protein supplementation during dialysis will improve muscle mass,~     functional status and quality of life in inflamed malnourished hemodialysis patients.~     Therefore, the objectives of the current proposal are to examine in malnourished (body mass~     index < 23 kg/m2 or serum creatinine < 8 mg/dL) hemodialysis patients with inflammation (high~     sensitivity CRP > 3 mg/dL), the effects of protein supplementation on~        1. Muscle mass as determined by creatinine kinetics~        2. Functional status as assessed by 6 min walk~        3. Quality of life as assessed by Short Form -12 survey~   "
130800|NCT01855282|"~     This is a study to assess the effectiveness of a culturally appropriate behavioral~     intervention to reduce obesity levels and ultimately the risk of developing diabetes type II~     in immigrant Latino farm workers. Workers enrolled in a 2:1 ratio by random allocation into~     an intervention or control arm of the study. The intervention participants received weekly~     classes for 10 weeks with education on diabetes, diet and physical activity and practical~     exercises. Both control and intervention were measured for weight, waist circumference,~     fasting blood glucose and interviewed before and after the study intervention. The main~     hypothesis was that intervention, but not control participants, would experience reduction in~     body measurements after the intervention.~   "
130801|NCT01855269|"~     The aim was to test the hypothesis that oral administration of Lactobacillus reuteri in a~     prospective randomized controlled study would improve symptoms of infantile colic.~   "
130802|NCT01855256|"~     Evaluation of the effectiveness of oxybutynin in hyperhidrosis~   "
130803|NCT01855243|"~     Purpose: To compare efficacy and safety of traditional sliding scale insulin (SSI) versus~     modified 70/30 insulin versus modified basal plus supplemental scale /bolus insulin regimens~     for glycemic control in hospitalized diabetic patients with diabetes.~      Methods: In a prospective trial, patients with diabetes will be randomized to receive either~     traditional hospital SSI , or twice daily 70/30 insulin plus supplemental lunchtime insulin~     for BG ≥ 150 mg/dL or once every night glargine plus three times prandial glulisine for BG ≥~     150 mg/dL . 70/30 insulin and glargine will be started respectively at 0.4 and 0.2 U/kg/day~     for BG ≤ 200 mg/dL or 0.5 and 0.3 U/kg/day for BG above 200 mg/dL.~   "
130804|NCT01855230|"~     The purpose of this study is to evaluate the safety, tolerability, and clinical activity of~     ASM-024 administered as a dry powder for inhalation formulation to patients with GOLD 2 or~     GOLD 3 COPD.~   "
130805|NCT01855217|"~     Should the dose of sugammadex in morbid obese patients be calculated on the real body weight~     or the ideal body weight?~      To study the pharmacodynamics of sugammadex in morbidly obese patients by comparing 1 mg/kg~     IBW versus 1 mg/kg TBW versus placebo.~   "
130806|NCT01855204|"~     Computed Tomographic (CT) urography is the best imaging modality to evaluate obstructing~     lesions of urinary tract such as urinary stone, tumor and inflammatory lesion. The purpose of~     our study is to compare images of CT urography performed by low voltage and low concentrated~     iodine CT contrast with them of conventional CT urography.~   "
130807|NCT01855191|"~     Introducing standardized data collection (SDC) for lung cancer patients to improve the~     performance of the prediction models.~   "
130827|NCT01854931|"~     The overarching objective of this project is to assess the potential public health impact of~     delivering Tai Ji Quan: Moving for Better Balance, a proven fall prevention program, through~     local community dissemination partners (e.g., senior service providers), in the selected~     counties in the state of Oregon.~   "
130828|NCT01854918|"~     This study will contribute to the evaluation of long-term safety, tolerability and efficacy~     of evolocumab (AMG 145) in subjects with hyperlipidemia and subjects with mixed dyslipidemia.~   "
130810|NCT01855152|"~     800,000 people in the United Kingdom (UK)have dementia, of which 250,000 are living in care~     homes. These individuals have complex mental health problems, disabilities and social needs,~     which if unmet will continue to adversely affect each individual, as well as the main goal of~     enabling people to live well with dementia, as presented in the National Dementia Strategy~     (NDS) (Department of Health, 2009).~      This optimized intervention WHELD is based on a factorial study and qualitative evaluation~     designed to facilitate the design of this current study and will combine this with the most~     effective elements of existing approaches to develop a comprehensive but practical~     intervention to improve quality of life in persons with dementia living in care homes. The~     intervention will combine training on person centred care, promoting person centred~     activities and interactions and provide care home staff and general practitioners with~     updated knowledge regarding the optimal use of psychotropic medications for persons with~     dementia in care homes.~      The overarching goal of this trial is to determine whether this optimised WHELD intervention~     is more effective in improving the quality of life and mental health, than the usual care~     provided people with dementia living in nursing homes. The cost effectiveness of the~     intervention will be assessed as well, with the aim to provide a cost effective, simple and~     practical intervention, improving quality of life and mental health of people with dementia~     in care homes; which can be rolled out nationally to all UK care homes as an National Health~     Service (NHS) intervention. The trial will be a randomised controlled 2-arm cluster single~     blind trial that will take place for 9 months across 80 care homes in UK.~   "
130811|NCT01855139|"~     The objective of this NIS is to assess in a real-life setting, usage patterns and associated~     outcomes in the management (healthcare resource utilisation and associated costs) of patients~     with non-valvular AF treated with Xarelto, in accordance with the terms of the European~     marketing authorization and the Belgian reimbursement criteria.~   "
130812|NCT01855126|"~     In conjunction with investigators at the Cecil G. Sheps Center for Health Services Research,~     University of North Carolina (UNC) at Chapel Hill, we propose to develop and evaluate a~     low-cost, minimally obtrusive device that delivers individualized light therapy to adults~     with early-awakening insomnia - the most common sleep disturbance in older adults, and a~     significant problem because of its relationship to daytime sleepiness, use of potentially~     hazardous sleep medication, and reduced quality of life. The proposed device will measure~     light/dark exposure data over 24 hours, estimate optimum timing for light delivery, and~     deliver an individualized light dosage while subjects are asleep. Light applied through~     closed eyelids in the early part of the night will delay the dim light melatonin onset, a~     marker of the circadian clock, and help those with early sleep onset to fall asleep later~   "
130813|NCT01855113|"~     This study aims to compare the pain experienced by patients undergoing orthodontic treatment~     with Invisalign ® corrective aligners with that of patients undergoing orthodontic treatment~     with conventional braces. Because the aligners are removable, nearly invisible and don't~     involve metal that can irritate teeth and gums, we are expecting less pain in the Invisalign~     Treatment and less affectation of the quality of life.~   "
130814|NCT01855100|"~     The objective of this NIS is to assess in a real-life setting, usage patterns and associated~     outcomes in the management (healthcare resource utilisation and associated costs) of patients~     with acute deep vein thrombosis treated with Xarelto, in accordance with the terms of the~     European marketing authorization and the Belgian reimbursement criteria.~   "
130815|NCT01855087|"~     There is paucity of information about the combination therapy with dipeptidyl peptidase-4~     inhibitor sitagliptin and insulin. This study aimed to retrospectively investigate the safety~     and efficacy of this therapeutic modality in Japanese patients with type 2 diabetes.~   "
130816|NCT01855074|"~     The purpose of this study is to evaluate the efficacy and safety of long acting injectable~     microspheres of risperidone in participants with schizophrenia (psychiatric disorder with~     symptoms of emotional instability, detachment from reality, often with delusions and~     hallucinations, and withdrawal into the self), schizophreniform or schizoaffective disorders~     (disorders in which there is a loss of ego boundaries or a gross impairment in reality~     testing with delusions or prominent hallucinations).~   "
130817|NCT01855061|"~     The purpose of this study is to determine whether it is possible to predict response to~     chemotherapy in patients with metastatic cancer who are treated with irinotecan by~     determining the mutational profile of the tumor.~   "
130818|NCT01855048|"~     The Objectives of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics~     of single dose of N-Rephasin® SAL200 in healthy male subjects.~   "
130819|NCT01855035|"~     The purpose of this study is to assess whether repeated enhanced and prolonged ECG monitoring~     after ischemic stroke results in a higher detection of atrial fibrillation (/flutter)~     compared to usual care (at least 24 hour of cardiac monitoring).~   "
130820|NCT01855022|"~     The primary purpose of this study is to determine the effectiveness of a hospital-based~     intervention, using motivational interviewing and interactive voice response (IVR), to reduce~     hospital readmissions within 90 days of enrollment compared to usual care, for patients with~     heart failure and chronic obstructive pulmonary disease.~   "
130821|NCT01855009|"~     This study will compare changes in body composition (lean mass, fat, and bone)and parent~     ratings of quality of life in 5-19 Year Olds as a function of participation in one of four~     versions of the Good NEWS 4 Kids Program (GN4K).~   "
130822|NCT01854996|"~     This study aims to test plasma exposure to PF-05089771 with same formulation will be used for~     phase II trials (capsule).~   "
130823|NCT01854983|"~     Clinical Trial to access Significance of fluorescence colposcopy with autofluorescence~     imaging for the screening of cervical cancer~   "
130824|NCT01854970|"~     Laryngopharyngeal reflux (LPR) is the retrograde movement of gastric contents into the~     larynx, pharynx and upper aerodigestive tract. The symptoms and manifestations are very~     changeable and non specific. Pharyngeal and Oesophageal pH-impedance may help to detect these~     reflux and to identify patients with abnormal LPR.~      To compare and describe the results of pharyngeal and oesophageal pH-impedance of patients~     with high suspicion of laryngopharyngeal reflux, with the results of healthy patients.~   "
130825|NCT01854957|"~     A double-blind, randomized, cross-over phase I/II study to evaluate the safety and the~     efficacy of the intravenous administration of autologous Mesenchymal Stem Cells (MSC) to~     patients with active multiple sclerosis (MS) resistant to currently available therapies.~   "
130830|NCT01854892|"~     Low back pain (LBP) is one of the most common reasons for seeking medical care and accounts~     for over 3.7 million physician visits/year in the U.S. alone. Ninety percent of adults will~     experience low back pain in their lifetime, 50% will experience recurrent LBP, and 10% will~     develop chronic pain and related disability.~      While there is growing evidence for the clinical effectiveness of alternative and~     complementary therapies to treat low back pain, little is known on the physiologic~     consequences and effects of these treatments. Further, additional data is needed to~     understand how these different treatment techniques effect clinical changes in pain and~     disability. The lack of empirical data hinders acceptance by the wider scientific and~     health-care communities, and it also limits the development of rational strategies for using~     alternative and complementary therapies.~   "
130831|NCT01854866|"~     Malignant ascites and pleural effusion are common symptoms in patients with advanced cancer.~     Currently, the management of malignant ascites and pleural effusion is a considerable~     clinical challenge. The investigator hypothesized that tumor cell-derived microparticles~     packaging chemotherapeutic drugs might be a useful means to treat malignant ascites and~     pleural effusion. Thirty malignant ascites or pleural effusion patients will be recruited for~     Phase II clinical trials.~   "
130832|NCT01854853|"~     Adolescents with mental health (MH) disorders (MHD) have higher rates of HIV/STI sexual risk~     behaviors than those in the general population. In Brazil, among youth seeking HIV testing,~     those testing positive had more MH problems than HIV-negative youth; HIV/STI sexual risk~     reduction is not regularly implemented within MH care for adolescents. Our NIMH-funded RCT in~     Rio de Janeiro (Rio; R01MH065163; PI: Wainberg) promises to provide such intervention for~     adults with MHD. A comparable evidence-based HIV/STI prevention intervention for adolescents~     is not available in Brazil; this application targets this need.~      Using quantitative and qualitative methods we will explore the contextual influences on~     sexual risk behavior of Brazilian youth ages 13-24 with MHD to inform intervention~     adaptation. The investigators will then pilot-test the family-based (parent-adolescent dyad)~     intervention HIV, STI and pregnancy prevention intervention with a sample of male and female~     youth age 13-24 years (n=144) with MHD who are in MH treatment in four community-based sites~     in preparation for the RCT.~   "
130833|NCT01854840|"~     Primary purpose: to study the relationship between betamethasone placental transfer and the~     occurrence and severity of the Hyaline Membrane Disease.~   "
130834|NCT01854827|"~     The Children Liver Disease Research and Education Network (ChiLDREN) is conducting a clinical~     trial to determine the feasibility, acceptability, tolerability and safety profile of IVIG~     treatment administered to infants after hepatic portoenterostomy (HPE) for biliary atresia,~     as well as investigate preliminary evidence of activity and explore mechanisms of action.~   "
130835|NCT01854814|"~     The study is to evaluate the effect of Mycophenolate Mofetil compared with losartan alone on~     time to doubling of serum creatinine or the onset of end stage renal disease in patients with~     advanced IgA nephropathy who are treated with the maximal tolerated daily dose of~     losartan.The study will also assess the effects of MMF compared with losartan alone on the~     changes of urine albumin excretion and the changes in estimated glomerular filtration rate.~   "
130836|NCT01854801|"~     The purpose of the study is to evaluate efficacy of a 14 months follow-up and individual~     medical care of electro-sensitive patients: by measurement of health status, sensitivity to~     electromagnetic fields exposures, and quality of life.~   "
130837|NCT01854788|"~     Study design: a randomized, crossover trial. Each patient performed three different airway~     clearance techniques (Autogenic drainage, slow expiratory with glottis opened in lateral~     posture [ELTGOL], temporary- positive expiratory pressure [T-PEP] with not similar autonomy~     degree in a randomized order. Each technique were applied in 3 sessions during one week at~     alternate days (Monday /Wednesday/Friday or Tuesday/Thursday/Saturday). The time spent in~     each bronchial session was 40 minutes. Seven days were the wash-out time period between the~     different techniques.~   "
130838|NCT01854775|"~     There will be 2 cohorts in this study, each consisting of Part A and Part B.~      The primary objectives of Cohort 1 are to evaluate the steady state pharmacokinetics (PK) for~     elvitegravir (EVG) and tenofovir alafenamide (TAF) and confirm the dose of the~     elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) single tablet regimen~     (STR) (Part A) and to evaluate the safety and tolerability of E/C/F/TAF STR through Week 24~     (Part B) in HIV-1 infected, antiretroviral (ARV) treatment-naive adolescents.~      The primary objectives of Cohort 2 are to evaluate the PK of EVG and TAF in virologically~     suppressed HIV-1 infected children 6 to < 12 years of age weighing ≥ 25 kg administered~     E/C/F/TAF STR (Part A) and to evaluate the safety and tolerability of E/C/F/TAF STR through~     Week 24 in virologically suppressed HIV-1 infected children 6 to < 12 years of age weighing ≥~     25 kg.~   "
130839|NCT01854762|"~     The current available antiretroviral (ARV) agents make possible a successful treatment of~     virtually all HIV-infected patients, even those heavily experienced subjects, with a history~     of previous failure to ARV drugs of different classes. However, some problems are still~     present, especially for specific populations, like pregnant women and infants. For these~     groups, most of currently available drugs are not used, because the lack of information on~     safety, efficacy, and pharmacokinetic/dynamic behavior of ARVs drugs. The mother to child~     transmission (MTCT) is still a problem in certain areas of the world, especially in~     resource-limited settings. In some settings, women often present to their first antenatal~     care visit late in the pregnancy, posing an additional problem: how to effectively treat~     these patients to assure they will have an undetectable viral load at the moment of~     delivering? Depending on the plasma viremia magnitude, and viral susceptibility it can take 6~     or more weeks to reduce the viral load to less than the desired 1,000 copies of HIV-1 RNA /~     ml of plasma. To achieve this goal, it would be necessary the use of a potent, very~     efficacious ARV regimen that could provide such viral decay in a very short period.~     Raltegravir (RAL), the first HIV-1 integrase inhibitor, is a potent and safe ARV drug. The~     available evidence suggest it has no genotoxic potential, and promotes a rapid decline in~     HIV-1 plasma viremia. In addition, RAL is highly active against viral strains presenting~     different degree of resistance to other ARV drugs. Thus, RAL could be an ideal candidate to~     be used for prevention of MTCT for women with detectable viral load, presenting late in the~     course of pregnancy. Another attractive point is to consider that, due to the similarity~     between the integrase enzyme of HIV-1 and Human T-cell lymphotropic virus type-1 (HTLV-1);~     RAL could be active against HTLV-1, blocking its replication. If our hypothesis is correct,~     the use f RAL-containing ARV regimens would reduce the MTCT of both agents. This study has~     the objective of evaluating the efficacy of RAL containing ARV regimens in reducing the HIV-1~     RNA plasma viral load below 50 copies/ml, at the end of pregnancy, for late-presenters~     pregnant women and to compare the frequency of adverse events for women using RAL-based ARV~     regimens and comparators, and for their babies.~   "
130840|NCT01854749|"~     Assess the efficacy and safety of S1 combined with cisplatin in treatment of~     recurrence/metastasis of ESCC~   "
130841|NCT01854736|"~     This trial is an exploratory randomised, parallel-group, double-blind, placebo- controlled,~     national, single-centre trial.~      The trial will be initiated before 2013 grass pollen season and subjects will be randomised~     in September 2013 to receive active treatment (Grazax®) or placebo during 2 years. Placebo~     group will be treated 2 years with placebo and a third year with active therapy (Grazax®) and~     active group will continue the active treatment in the third year. In the last year, all~     placebo patients will be changed to active group and active and placebo patients will be~     informed about, but the trial will not be unblinded until the end of the third year and~     patients won´t know what treatment they were assigned to during the first 2 years.~   "
130842|NCT01854723|"~     This study will compare the safety, effectiveness, and cost of two different types of~     long-acting insulin.~   "
130843|NCT01854710|"~     Assess the potential effects on the QT interval of 2 consecutive doses of ADASUVE~     administered 2 hours apart, in relation to placebo and an active control in healthy~     volunteers.~   "
130844|NCT01854697|"~     This is a study to evaluate the efficacy and safety of three experimental drugs compared with~     telaprevir (a licensed product) in people with hepatitis C virus infection who have not had~     treatment before.~   "
130845|NCT01854684|"~     This phase I trial studies the side effects and best dose of photodynamic therapy during~     surgery in treating patients with non-small cell lung cancer that can be removed by surgery.~     Photodynamic therapy uses a drug, such as temoporfin, that becomes active when it is exposed~     to a certain kind of light. When the drug is active, cancer cells are killed. This may be a~     better way to treat patients with non-small cell lung cancer.~   "
130846|NCT01854671|"~     The purpose of this study is to measure the difference in proportion of postpartum women~     using contraception after a Community Health Worker (CHW) family planning educational~     intervention compared to women who receive standard care in the West Bank district of~     Ramallah and Al-Bireh.~      Primary hypothesis: Postpartum contraceptive use will increase in women who receive a~     dedicated family planning counseling intervention delivered by CHWs during antenatal care~     compared to women receiving usual care.~   "
130847|NCT01854658|"~     This is a multicenter, randomized, double-blind, parallel group, chronic-dosing (24 weeks),~     placebo-controlled study to assess the efficacy and safety of Glycopyrrolate (GP and~     Formoterol Fumarate (FF) combination metered-dose inhaler (MDI) (GFF; PT003), GP MDI (PT001),~     and FF MDI (PT005) compared with Placebo MDI in subjects with moderate to very severe COPD.~   "
130848|NCT01854645|"~     The overall objective of this study is to assess the efficacy and safety of treatment with~     PT003 (GFF MDI), PT005 (FF MDI), PT001 (GP MDI), and open-label tiotropium bromide inhalation~     powder compared with each other and Placebo MDI over 24 weeks in subjects with moderate to~     very severe COPD.~   "
130849|NCT01854632|"~     This study will provide the Senegal Ministry of Health with data on the clinical efficacy of~     the Live-Attenuated Influenza Vaccine (LAIV). This data will inform future policy~     considerations for influenza vaccine.~   "
130850|NCT01854619|"~     The purpose of this study is to determine whether the use of light and a topically applied~     photosensitizer can relieve symptoms and clinically improve patients with chronic~     rhinosinusitis.~   "
130851|NCT01854606|"~     Study of the safety and efficacy of AEB071 and EVEROLIMUS in patients with CD79-mutant or ABC~     subtype Diffuse Large B-Cell Lymphoma.~      The trial did not progress into Phase II due to the suboptimal tolerability of the~     combination treatment of sotrastaurin and everolimus in the Phase Ib part of the study. There~     were no serious safety concerns associated with this combination.~   "
130852|NCT01854593|"~     We hypothesized that to reduce the adverse effects of intravitreal bevacizumab on ocular~     tissue and whole body, intravitreal injection of a low concentration of bevacizumab and~     conducting vitrectomy shortly after the injection is useful. In the present prospective,~     double-masked, randomized, controlled study, we aimed to verify the usefulness of~     intravitreal injection of 0.16 mg/0.05 ml bevacizumab one day before conducting vitrectomy~     for PDR.~   "
130853|NCT01854580|"~     The purpose of the study is to investigate the effectiveness and cost-effectiveness of the~     integrated care program of a statutory health insurance offering additional homeopathic~     treatment to their members~   "
130854|NCT01854567|"~     The study investigates the time to engraftment of a mesenchymal expanded cord blood unit in~     patients with hematologic malignancies undergoing transplantation with myeloablative~     conditioning.~   "
130855|NCT01854554|"~     The goal of this clinical research study is to compare IMRT with IMPT in patients with~     glioblastoma. Researchers want to learn about cognitive side effects (mental status changes)~     that may occur, such as memory loss and impaired thinking.~      IMRT is the delivery of focused radiation therapy using photon beams and advanced computer~     planning to help shape the dose in order to give the highest possible dose to the tumor with~     the least dose to surrounding normal tissues.~      IMPT is also focused radiation therapy similar to IMRT, but it uses proton particles to~     deliver the radiation instead of photon beams. IMPT also uses advanced computer planning in~     order to shape the dose to the target with the least dose to surrounding normal tissues.~   "
130856|NCT01854541|"~     The Visual Management for Radiotherapy Practice (VMRTP) aims to analyze, predict, visualize~     and shorten the waiting times for radiotherapy patients. The hypothesis is that this can be~     done by the introduction of models that can predict a patient being at risk for waiting too~     long as well as visual management tools that visualize the radiotherapy process.~   "
130857|NCT01854528|"~     The purpose of this study is to evaluate the safety and antiviral activity of 3 direct-acting~     antiviral agents (DAAs; ABT-450/ritonavir/ABT-267 [ABT-450/r/ABT-267; ABT-267 also known as~     ombitasvir] and ABT-333 [also known as dasabuvir]) plus ribavirin (RBV) compared with~     telaprevir (TPV) with pegylated interferon/ribavirin (pegIFN/RBV) in patients with chronic~     hepatitis C virus genotype 1 (HCV GT1) infection without cirrhosis who were previously~     treated with pegylated interferon/ribavirin (pegIFN/RBV).~   "
130910|NCT01853839|"~     This is an out-patient based prospective, multi-centre, observational post-marketing~     surveillance study amongst internists and cardiologists. In this study, patients with~     essential hypertension and at least one additional risk factor will be included. Patients may~     take any antihypertensive treatment which is approved for cardiovascular protection including~     Micardis 80 mg / Micardis Plus. Patients will be followed over one year in four visits from~     baseline to endpoint with an additional visit before and after the month of Ramadan.~   "
130858|NCT01854515|"~     The present study was aimed at investigating the efficacy of nebulizing Budesonide sin~     comparison with intravenous Dexamethasone before extubation in prevention of post-extubation~     complications amongst patients admitted in intensive care unit.~      In this double-blind randomized clinical trial study, 90 patients (age between 18 to 65) who~     are intubated (at least for 48 hours) and now are ready for extubation will be enrolled in~     the study after obtaining a written informed consent from their parents or guardians.~      The investigators divide our patients randomly into two equal groups.~      -In the budesonide group patients underwent a therapy with nebulizing Budesonide at a dose of~     1 mg diluted in 4 cc of sterile water for 20 minutes, one hour preceding extubation. After~     extubation patients received nebulizing budesonide via oxygen mask at the same dose every 12~     hours for 48 h.i In dexamethasone group intravenous dexamethasone was administered to patient~     at a dose of 0.15 mg/kg before extubation. After extubation, the administration of~     intravenous Dexamethasone continued at the same dose every 12 h. for 48 h.~      Another anesthesiologist who is unaware about kind of medication, will evaluate the patients~     for severity of stridor. We will record the vital sings and grade of stridor every 6 hour.~     Respiratory rate (RR), heart rate (HR), blood pressure (BP) and oxygen saturation (SPO2) were~     recorded for each patient immediately before aerosol administration (time 0) and at 30 and 60~     min; and 2,4,8,12,24,36 and 48 hrs. After extubation then the presence of stridor (heard with~     the aid of stethoscope) was recorded within 48 hr of extubation~   "
130859|NCT01854502|"~     The purpose of this study is to compare the effects of two new family-based oral health~     promotion programs with the routine program in use earlier in Vantaa public dental service.~     The children born in 2008 were followed from their first visit to public dental service at~     the age of 6-12 months to their dental examination at the age of 2-2½ years. The outcome~     measures are the colonization of mutans streptococci in dental plaque, dental caries, and the~     oral health habits of two-year-olds.~   "
130860|NCT01854489|"~     This study is aimed to examine the possible interactions of sublingual and intravenous~     buprenorphine with rifampicin.~   "
130861|NCT01854476|"~     Patients on chronic treatment with hemodialysis have an arterio-venous fistula which enable~     the insertion of two large gauge needles. At the end of dialysis the needles are extracted~     and continuous pressure is needed to stop the bleeding. Time to bleeding cessation is~     different between patients and may be up to 20 minutes. Acquired coagulopathy in patients on~     chronic hemodylasis is a well known entity. The coagulopathy is multi-factorial including~     uremic thrombocytopathia, the presence of anemia, the use of anti-platelets and/or~     anti-coagulation drugs and the regular use of heparin during dialysis. Tranexamic acid~     (Hexakapron) is an anti-fibrinolytic drug that has a proven efficacy in reducing blood loss~     at different clinical settings. The drug may be given systemically (PO/IV) or applied locally~     on the site of injury.~      The aim of the study is to assess the efficacy and safety of a pad gauze dressing containing~     tranexamic acid.~      Study design:~      A Double-blind study comparing pad-gauze with tranexamic acid (Hemostopan™) to a regular~     pad-gauze. The type of dressing for each dialysis session will be decided in a random manner.~     In each dialysis session only one type of dressing will be used for both insertion points.~      Protocol for applying the dressing:~      Following the needle extraction either dressing A or B will applied with slight pressure~     for 2 minutes. If bleeding stops it will be the end of session.~      If bleeding persists than another dressing of the same kind is applied with slight pressure~     for 4 minutes. If bleeding stops it will be the end of session.~      If bleeding persists than another dressing of the same kind is applied with slight pressure~     for 6 minutes. If bleeding stops it will be the end of session.~      If bleeding persists than it will be consider a failure and a regular measures will be used~     until bleeding stops.~      Each session will be documented in the patient's case report file (CRF). The primary end~     point of the study: Time to bleeding cessation~   "
130862|NCT01854463|"~     In many observational studies, vitamin D deficiency is related to glucose intolerance and~     diabetes. But there little randomized, controlled interventional studies that evaluate the~     effect of vitamin D in type 2 diabetes.~      Investigators investigate the effect of high dose (2000IU) 25-hydroxy vitamin D on type 2~     diabetes in glycemic controls, non-alcholic fatty liver disease, and arterial stiffness, and~     bone turnover markers.~   "
130863|NCT01854450|"~     Maternal posturing is used during labor to facilitate the rotation of occipitoposterior fetal~     position in anterior.~      Our study aims to evaluate the efficacy of asymmetrical lateral decubitus for rotation of the~     fetal head.~   "
130864|NCT01854437|"~     Hyperphosphatemia is a common problem in hemodialysis (HD) patients. Different chelators for~     control of Hyperphosphatemia are used. The aim of this study was to assess the effect of~     magnesium oxide (Mg Oxide) on the control of serum phosphorus (P) level and evaluation of its~     side effects in hemodialysis patients.~   "
130865|NCT01854424|"~     Fibrocyte is a monocyte sub-population involved in fibroproliferation/repair processes and~     associated with outcome in different diseases. In previous study, we have demonstrated the~     presence of alveolar fibrocytes during Acute expiratory Distress Syndrome (ARDS) and their~     association with patient outcome. The purpose of this multicentric observational prospective~     study is to describe the percentage of alveolar fibrocytes in ICU patients with ARDS~     (survivors vs. non survivors) and to confirm their association with 28-day mortality.~   "
130866|NCT01854411|"~     The purpose of this study is to determine whether ibuprofen and ketoprofen do not enter into~     mature breastmilk that could allowed breastfeeding during a long time~   "
130867|NCT01854398|"~     The association of obstructive sleep apnea (OSA) and cardiac diastolic dysfunction have been~     reported, and improvement of diastolic function after continuous positive airway pressure~     (CPAP) in OSA patients was observed. However, more detailed analysis of diastolic function by~     supine bicycle exercise echocardiography is lacking. The investigators hypothesized that 3~     months of CPAP therapy in OSA patients will significantly improve diastolic functional~     parameters measured by exercise stress echocardiography. Patients with severe OSA~     (Apnea-hypopnea index > 30) will be included in this study, and randomized to CPAP versus~     sham-CPAP group by 1:1 ratio. Supine bicycle exercise echocardiography, pulse wave velocity,~     24 hours ambulatory blood pressure (BP), central BP will be checked before and after CPAP~     therapy and parameters will be compared.~   "
130886|NCT01854151|"~     Variable and poor-quality drug labeling has been cited as a leading cause of medication~     errors and adverse drug events, especially in the context of low health literacy. This is a~     particularly important issue in pediatrics as more than half of US children are exposed to~     one or more outpatient medications in a given week, and studies suggest that over half of~     caregivers make errors when dosing liquid medications for children. Our study objective is to~     identify evidence-based strategies for labeling and dosing prescription and over-the-counter~     pediatric liquid medications in order to promote safe, appropriate use, as well as to inform~     state and federal policy standards. We hypothesize that a health literacy-informed labeling~     and dosing strategy will result in improved parent ability to administer medications~     prescribed to their young children.~   "
130911|NCT01853826|"~     To evaluate the safety and tolerability of afatinib (Giotrif) in patients with locally~     advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR mutation(s) and have~     never been treated with an EGFR-TKI~   "
130868|NCT01854385|"~     This phase II evaluation of sumatriptan as a treatment for post traumatic headache (PTH) will~     examine the methods and approach necessary to take the next step to a phase III trial. The~     sample will include 40 persons with mild complicated, moderate or severe TBI who will be~     recruited from patients discharged from the acute rehabilitation unit as well as outpatient~     clinics and the community who are between 3 and 24 months of injury and will be followed over~     3 months. The investigators plan to enroll those who have moderate to severe headache with~     frequency of at least four and up to a maximum of fifteen total headache days per month and~     at least three months after discharge from hospital. The investigators will use headache~     diaries to track the headaches for a month. If subjects still have significant headache, the~     investigators will instruct them in the use of sumatriptan 100 mg. to treat headaches. The~     subjects will continue to keep daily headache diaries. The investigators will evaluate them~     at baseline, Day 30 and Day 90. Each subject will receive weekly telephone follow up calls~     from the research staff. The investigators will measure pain severity, duration, recurrence~     of headaches, and side effects and how well persons with TBI can use headache diaries.~   "
130869|NCT01854372|"~     To estimate the I-year progression-free survival probability in patients up to 70 years of~     age with previously untreated diffuse large B-celllymphoma (DLBCL), or with intermediate~     (Burkitt-like) lymphoma, whose tumor cells show MYC rearrangement, and who are treated with~     alternating cycles of Rituximab-HCV AD and Rituximab-Methotrexate-Cytarabine, in concert with~     optimal supportive treatment including Pegfilgrastim, prophylactic antimicrobials, and close~     clinical follow-up.~   "
130870|NCT01854359|"~     Background:~      - The Idebenone in Patients With Primary Progressive Multiple Sclerosis (IPPoMS) trial tested~     a new drug for multiple sclerosis. In the IPPoMS trial, participants took either idebenone or~     placebo. Researchers want to give idebenone to all participants for 1 year. It is still not~     certain whether idebenone can slow the progression of multiple sclerosis, but this study may~     help answer that question.~      Objectives:~        -  To provide idebenone to all participants on the IPPoMS trial.~        -  To collect data on the safety and effectiveness of idebenone for primary progressive~          multiple sclerosis.~      Eligibility:~      - Individuals at least 18 years of age who have completed 3 years in the IPPoMS trial.~      Design:~        -  The first study visit for this trial will happen on the same day as the last visit for~          the IPPoMS trial.~        -  Participants will provide a blood samples and will have a lumbar puncture. They will~          also receive a new supply of idebenone to take three times a day with food. They will~          keep a diary to report on any side effects.~        -  After this first treatment visit, participants will have two follow-up visits to the NIH~          6 months apart. These visits may be scheduled over multiple days. Participants will~          provide blood and urine samples. They will also have imaging studies of the brain and~          spine.~        -  Participants will have phone calls with the study researchers to provide updates on~          their condition and any side effects.~   "
130871|NCT01854346|"~     This trial investigates the behavioral effects of manualized social skills training (KONTAKT)~     in children´s and adolescents with high-functioning autism spectrum disorder with psychiatric~     comorbidity in a RCT, multicenter study. N = 288 are recruited from 10 child and adolescent~     psychiatric clinics in Stockholm County. The examination of genetic variants as predictors~     for outcome and a qualitative study of KONTAKT complete the trial.~   "
130872|NCT01854333|"~     Autism spectrum disorders (ASD) are early onset chronic conditions coined by deficits in~     social reciprocity, communication and stereotypic interests and activities. Other functional~     impairments such as mental retardation, ADHD, known genetic syndromes and epilepsy are~     frequent coexisting problems. ASD cause considerable suffering for the affected individuals~     and burden for their families. With an estimated prevalence exceeding 1%, recent~     population-based studies suggest that ASD are no rare phenomena. Lifetime societal costs for~     services and support, together with the opportunity costs of lost productivity in a~     prototypic developed country are estimated SEK 15.6 million for someone with and SEK 10.3~     million for a person without co-existing mental retardation. Despite ongoing efforts, no~     diagnostically informative biomarker has yet been identified for ASD. The development,~     refinement and evaluation of behavioral assessment tools has therefore been decisive to~     progress and quality assurance in ASD clinical practice and research. The most widely used~     and thoroughly evaluated instruments for ASD in international child mental health are the~     Autism Diagnostic Interview- Revised (ADI-R) and the Autism Diagnostic Observation Schedule~     (ADOS). The ADI-R and ADOS are deemed highly by the ASD expert community and thus commonly~     labeled as being the gold standard in ASD diagnostics. Although, Swedish translations of~     the ADI-R and ADOS exist, a Swedish standardization and cross-cultural validation is still~     lacking, impeding good clinical practice and research prerequisites for ASD in Sweden. The~     applied project seeks to broadly establish reliability and validity of the Swedish~     translations of the ADI-R and ADOS in order to enhance evidence-based clinical practice and~     stimulate internationally competitive ASD research in Sweden.~   "
130873|NCT01854320|"~     The primary goal of this project is to determine if an innovative behavioral weight loss~     program that incorporates new developments from the field of behavior therapy produces~     superior weight control than standard behavioral treatment. A sample of 200 adults from the~     community are participating in this study.~   "
130874|NCT01854307|"~     Perioperative goal directed fluid therapy may reduce complication rate after surgery. Minimal~     invasive cardiac output monitoring is a key method to guide fluid therapy. More operations~     are being performed by keyhole surgery (laparoscopy). For laparoscopy, the abdomen is filled~     with carbon dioxide. Increased pressure in the abdomen may influence minimal cardiac output~     monitoring, therefore minimal cardiac output monitoring is not recommended during~     laparoscopy. This study aims to validate minimal cardiac output monitoring during laparoscopy~     and therefore facilitate for goal directed fluid therapy.~   "
130887|NCT01854138|"~     Determine the extent to which application of the Prevena vacuum system to clean surgical~     incisions immediately following surgical procedure (total hip or total knee arthroplasty)~     will reduce the rates of:~        -  readmission to hospital for surgical intervention due to wound complications~        -  seroma~        -  hematoma~        -  infection compared to group of patients whose wounds were covered with traditional gauze~          dressings.~   "
131200|NCT01850043|"~     TST will be analyzed in young general population in Korea. Young adults undertake TST as CDC~     recommendation. Participants with chest radiograph showing active TB lesion are excluded from~     this study.~   "
130875|NCT01854294|"~     GM604 is an endogenous human embryonic stage neural regulatory and signaling peptide that~     controls the development, monitoring and correction of the human nervous system. Neurological~     diseases are multisystem, multifactorial, and single target drugs are ineffective. Genervon's~     Master Regulators play a significant role in embryonic/fetal nervous system development and~     are potent disease modification drug candidates modulating many pathways including~     inflammation, apoptotic, and hypoxia. The study drug is an regulatory peptide with a sequence~     identical to one of the active sites of human Motoneuronotrophic Factor and is manufactured~     by solid phase synthesis. Pre-clinical research indicates it to be a neuro-protective agent~     in animal models of ALS, motorneuron diseases, PD, other neuro-degenerative diseases and~     stroke. GM604 controls and modulates over many known and significant ALS genes with positive~     effects interactively and dynamically through multiple pathways, and up to twenty-two~     biological processes, including neuro-protection, neurogenesis, neural development, neuronal~     signaling, neural transport, and other processes. GM6 is not a cocktail of drugs, but one~     master regulator peptide drug that functions through multiple pathways. Genervon hypothesized~     that studying the biomarkers of protein expressions of these ALS genes such as SOD1 and the~     protein expression of substances such as tau, NF-H, Cystatin C which were indications of~     degeneration of neuron in the CSF collected from ALS patients will provide information of the~     possible GM604's mechanisms of action in treating ALS. 1. This pilot trial is designed to~     test proof of principle, i.e. determine if a 2-week IV bolus treatment with this agent can~     (1) change ALS protein expression (target biomarkers and efficacy biomarkers) after treatment~     (2) have preliminary effects measures of ALS disease clinical progression.~      Study Objectives are:~        1. To test the safety and tolerability of GM604 in a population of ALS patients.~        2. To test for changes in ALS biomarkers before and after treatment.~        3. To determine preliminary effects of injections of GM604 on measures of ALS disease~          biomarkers and clinical progression~   "
130876|NCT01854281|"~     The aim of this study is to determine whether catheter-based closure of patent foramen ovale~     is effective in preventing paradoxical embolization of nitrogen bubbles after simulated~     dives.~   "
130877|NCT01854268|"~     Cough is a defensive behavior that involves three stages. A large inspiratory phase, a~     compression phase where the vocal folds close and subglottal pressure is developed, and an~     expiratory phase. Cough serves to protect the upper and lower airways from material such as~     liquids, solids, or saliva, that have been aspirated. There are two types of cough: voluntary~     and reflex cough. Voluntary cough involves a cough to command. Reflex cough is a cough that~     is generated secondary to a stimulus in or near the airway. There has been some research~     regarding the differences between voluntary and reflex cough. However, no research has~     described the differences in airflow or movement pattern (kinematics) between the two types~     of cough. This study seeks to determine the respiratory kinematics and airflow differences~     between voluntary and reflex cough in healthy participants.~   "
130878|NCT01854255|"~     A prospective series of patients with recurrent gastric cancer will be treated with three~     cycles of chemotherapy (doxorubicin and cisplatin) instilled into the abdominal cavity in the~     form of an aerosol under pressure via laparoscopy. The efficacy of this treatment will be~     assessed by computed tomography, tumor marker studies, and survival. Also, the safety of the~     procedure will be assessed.~   "
130879|NCT01854242|"~     The purpose of this research study is to understand the relationship between inflammatory~     bowel disease (IBD) and Glycogen storage disease (GSD)type Ia. GSD type Ib has been~     established to have an association with IBD with clinical and histologic features that mirror~     those of Crohn disease. Development of the disease seems to be related to the defect of~     neutrophil function in individuals with GSD type Ib and subsequent colonic inflammation. In~     the last decade, it has become a standard for patients with GSD type Ib and gastrointestinal~     symptoms to be evaluated for IBD. Patients with GSD type Ia were not recognized to have~     similar gastrointestinal symptoms until recently. The prevalence of IBD is greater in~     patients with GSD type Ia versus the general population.~   "
130880|NCT01854229|"~     The Prometra Pump is approved by the FDA for use in the United States. The purpose of this~     study is to collect long-term safety data on the Prometra Pump.~   "
130881|NCT01854216|"~     To investigate the repeated dose Pharmacokinetics (PK) of transdermally delivered Rotigotine~     in Japanese and Caucasian female and male healthy subjects.~   "
130882|NCT01854203|"~     Concurrent cisplatin-based chemotherapy plus radiotherapy increased the risk of~     treatment-related death and severe acute toxicity. The survival benefit of adding concurrent~     chemotherapy to intensity modulated radiation in patients with locoregionally advanced~     nasopharyngeal carcinoma is unclear. Gemcitabine plus cisplatin chemotherapy combine with~     radiotherapy was effective and well tolerated by patients with locoregionally advanced NPC.~   "
130883|NCT01854190|"~     The purpose of this study is to determine the prevalence of obstructive sleep apnea and~     associate it with the endothelial function behavior in patients with resistant hypertension.~     Two groups will be evaluate, one presenting uncontrolled high blood pressure, and other, with~     controlled blood pressure by drugs.~   "
130884|NCT01854177|"~     In previous studies we demonstrated that endogenous opioids (inhibitory neuropeptides)~     modulate the perception of breathing difficulty in patients with chronic obstructive~     pulmonary disease (COPD) (ERJ 2009;33:771; J COPD 2011;8:160). Recently, we found that~     antagonism of substance P (an excitatory neuropeptide) with aprepitant did not affect the~     perception of breathing difficulty. However, after administration of aprepitant, blood levels~     of both substance P(+ 54 ± 39%) and beta-endorphin (+ 27 ± 17%) increased significantly. As~     these blood levels reflect cellular/tissue activity, we postulated that the concomitant~     release of excitatory (substance P) and inhibitory (beta-endorphin) neuropeptides had~     opposing effects (counterbalanced each other) on the perception of breathing difficulty.~      The objective of the present study is to further examine the possible role of substance P on~     the perception of breathlessness. We propose to administer oral aprepitant and oral placebo~     in a randomized clinical trial in patients with COPD. However, four hours after patients take~     these medications, intravenous naloxone will be administered in order to block the effects of~     endogenous opioids (beta-endorphin) on opioid receptors. Five minutes later, patients will~     breathe thru a tube with fine wire mesh to provoke breathing difficulty, and then provide~     ratings of the intensity and unpleasantness of breathlessness every minute.~      The two competing hypothesis of the study are:~        1. if breathlessness ratings with aprepitant/naloxone = placebo/naloxone, then substance P~          has no effect on perception of breathing difficulty;~        2. if breathlessness ratings with aprepitant/naloxone ≠ placebo/naloxone, then substance P~          has an effect on perception of breathing difficulty.~   "
130885|NCT01854164|"~     This study was conducted to investigate the effects of daily supplementation of hydrolyzed~     ginseng extract(HGE) on glycemic status in subjects with impaired fasting glucose(IFG).~   "
130897|NCT01854008|"~     The aim of this study was to assess the effectiveness of the implementation of walking urban~     circuits in increasing the level of physical activity and exercise capacity in severe chronic~     obstructive pulmonary disease (COPD) patients after being enrolled in a pulmonary~     rehabilitation program.~   "
130888|NCT01854125|"~     Liver cirrhosis (LC) is the final destiny in chronic liver disease.The quality of life in~     liver cirrhosis patients with refractory ascites are very wretched. The objective of this~     study is to evaluate the therapeutic efficacy of autologous bone marrow mesenchymal stem~     cells (BMSCs) transplantation via liver artery in Child-Pugh B and C stage of liver cirrhosis~     patients with refractory ascites. The immunomodulatory impact of MSCs in fibrosis was~     confirmed, and several clinical studies have applied MSCs to eliminate the progression of~     fibrosis. In this research the investigators will study the affect and influence of MSCs in~     the patients,include assay of liver function,variation of ascites,Child-Pugh score etc.~   "
130889|NCT01854112|"~     Radiation therapy, total skin electron therapy (TSET), achieves a high response rate and is~     an effective treatment for cutaneous T-cell lymphoma affecting the superficial region 1. One~     the most widely used TSET techniques consists of six dual fields initially developed at~     Stanford University 2. Dosimetrically, TSET at energies of about 3-7 MeV at the surface of a~     standing patient may result in significant dose variations due to variable skin distance,~     self shielding, irradiated fields overlapping and patient motion. Deviations occur from the~     prescription dose up to 40% and the surface dose inhomogeneity as much as 90% in body areas~     such as the perineum and eyelid, are revealed in the literature. To improve this condition, a~     selection of patients with advanced skin disease and regional extension could be cured by a~     combination of TSEB and photon beam irradiation.~      Helical tomotherapy (HT) has advantages in irradiating extended volumes with treatment length~     of up to 160 cm, continuously in a helical pattern without the need for field junction. Total~     marrow irradiation (TMI) via HT with low toxicities for bone marrow transplantation of Asia~     multiple myeloma patients could be feasible . A study of HT for total scalp irradiation has~     also shown that the employment of directional and complete blocking on the inner structures~     can effectively force the tangential delivery of the majority of beamlets to the PTV, which~     can limit the treatment depth.~      Using HT, an image-guided intensity-modulated radiotherapy, to replace conventional TSI~     technique to increase dose delivery and decrease toxicities could be a workable and feasible.~     Here, we applied TSI via HT (HITS) for a woman with T cell lymphoma failure by chemotherapy,~     topic UV irradiation and local radiotherapy (RT) in MMH to overcome the surface dose~     inhomogeneity by conventional RT. Additionally, we will compare the advantages and~     disadvantages between the plan of HT and conventional RT for TSI.~   "
130890|NCT01854099|"~     Eligible adult patients with new diagnosis of gliobastoma are enrolled to receive 3 weekly~     vaccinations of the study drug PEP-CMV 1-3 days following standard of care chemoradiation.~     Patients will then be randomized to one of three arms: 1). standard temozolomide~     (TMZ)(200mg/m^2 for 5 days) with vaccine on day 6-8 of each monthly TMZ cycle. 2). standard~     TMZ (200mg/m^2 for 5 days) with vaccine on day 22-24 of each monthly TMZ cycle. 3).~     dose-intensified TMZ (100 mg./m^2 for 21 days) with vaccine on day 22-24 of each monthly~     cycle. All vaccines will be given intradermally (i.d.) and will be given with monthly TMZ~     cycles and continue after TMZ cycles until progression or death.~   "
130891|NCT01854086|"~     The purpose of the study is to provide information about the rate of response and persistence~     to drug therapies for osteoporosis. Another issue examined in this study refers to the~     preferences and concerns about future treatments in patients during drug holiday.~   "
130892|NCT01854073|"~     To determine the value of using Hyoscine as an antispasmodic drug for the management of~     prolonged labor in nulliparous women at term.~   "
130893|NCT01854060|"~     The prevalence of IBS in the community has been reported in numerous cross-sectional surveys.~     However, less is known about the incidence of IBS ,mainly due to its slow development and to~     patients under-reporting. Furthermore, only one study has analyzed data concerning potential~     risk factors for the diagnosis of IBS. The investigators will examine the incidence of IBS in~     a large cohort of young adults and will look at the association of socioeconomic,~     anthropometric and occupational factors with IBS incidence.~   "
130894|NCT01854047|"~     Primary Objective:~      To evaluate the efficacy of different doses and regimens of dupilumab in participants with~     moderate to severe uncontrolled asthma.~      Secondary Objective:~      To evaluate different doses and regimens of dupilumab in participants with moderate to severe~     uncontrolled asthma, with regard to:~        -  Safety and tolerability~        -  Dupilumab systemic exposure and anti-drug antibodies~   "
130895|NCT01854034|"~     This research study is a Phase II clinical trial, which tests the safety and effectiveness of~     an investigational drug to learn whether the drug works in treating a specific cancer.~     Investigational means that the drug is being studied. It also means that the FDA has not~     yet approved the drug for your type of cancer or for any use outside of research studies.~      It has been found that some people with NSCLC have a change (mutation) in a certain gene~     called the EGFR gene. This mutated gene helps cancer cells grow. The majority of NSCLC~     patients with EGFR mutations achieve good outcomes with erlotinib or other EGFR inhibitor~     therapies, with a high response rate, prolonged progression-free survival and possibly~     improved overall survival from therapy. However, the 4% of EGFR mutant patients that harbor~     an exon 20 insertion mutation historically have reaped little benefit from EGFR-directed~     therapy due to the low affinity of this mutation for direct EGFR inhibitors, especially~     erlotinib and gefitinib (see Yasuda et al, Lancet Oncol 2011). This group of patients is~     ideal for studying other targeted therapeutic strategies that could affect the oncogene~     mutation in EGFR via alternative mechanisms.~      AUY922 is an investigational drug that may stop cancer cells from growing abnormally. This~     drug has been used in other research studies. Information from those other research studies~     suggests that AUY922 may be effective in killing cancer cells in patients with exon 20~     insertion mutations in EGFR.~      The purpose of this study is to test the safety of AUY922 and determine how well AUY922 works~     for participants with advanced NSCLC and exon 20 insertion mutations in EGFR.~   "
130896|NCT01854021|"~     Surgical excision is the mainstay of treatment for tongue cancer. However, surgery-induced~     immunosuppression has been implicated in the development of post-operative septic~     complications and neoplasm metastasis. General anesthesia is considered to not only suppress~     surgical stress, but also affect the immune function directly，such as altering the number and~     activity of immune cells. It is reported that some anesthetics increase susceptibility to~     tumor metastasis, apparently by suppressing natural killer cell activity. Different~     anesthetic techniques and anesthetics used in anesthesia have shown different effects on~     immunity. Many of the studies were animal trials or performed in vitro; in addition, most are~     focused on a single drug. To date, there is little published prospective clinical research~     designed specifically to investigate the effects of different general anesthetic technique on~     immune function in patients with oral malignant tumors. The aim of this study is going to~     characterize the immune response of patients undergoing surgery for tongue cancer under 3~     types of general anesthesia.~   "
130901|NCT01853956|"~     The objective of this study was to confirm if two formulations of alprazolam (tablets) are~     bioequivalent.~      Test product was Zamoprax® 0.25 mg (GlaxoSmithKline) and reference product Tafil® 0.25 mg~     (Pharmacia & Upjohn). One tablet was the single dosage.~      The study was prospective, open-label, randomized, crossover, single dose, with 02~     treatments, 02 sequences and 02 periods, under fasting conditions.~      The population was composed of 28 healthy volunteers, both genders, adults between 18-50~     years.~      The comparative bioavailability of the two formulations was evaluated based in statistical~     comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations~     in blood.~   "
130902|NCT01853943|"~     Transradial coronary procedures are gaining in popularity worldwide. A possible complication~     of transradial approach is the occlusion of the radial artery that in most cases is~     asymptomatic. However the investigators do not know if the radial artery occlusion may impact~     over the muscle force of the hand or fingers.~      To evaluate if transradial approach for percutaneous coronary procedures may affect muscle~     force of the hand, thumb and index finger the investigators use a standardized hand-grip~     manometer and a pinch gauge before the transradial procedure, the day after the procedures~     and after few months.~   "
130903|NCT01853930|"~     Age-related macular degeneration (AMD) is the most common visual impairment in persons over~     50 years of age. It has been estimated that 1 in 3 individuals over 75 years of age and 1 in~     30 individuals over 52 years of age are affected by AMD. The deficits in visual function as a~     result of this disease affecting the central retina are debilitating, as individuals lose~     their ability to carry out many of their daily activities that require resolving fine spatial~     details. The investigator's previous studies have shown that training with oculomotor control~     exercises significantly increases reading speeds in patients with AMD. In the proposed study,~     the investigators will examine whether these training exercises are effective when practiced~     at home.~      In Phase 1, the investigators will develop a standardized user-friendly, Web-based platform~     that will allow patients to easily self-administer training exercises. The software platform~     will be designed to automatically choose the appropriate exercises based on a patient's~     previous performance, run the training exercise, and collect performance data into a~     universal patient data file. In Phase 2, the platform will be tested in two settings: in~     standard clinical rehabilitation practice and in the patient's home. Reading outcomes in the~     two settings will be compared. The investigators will recruit 60 patients per year for each~     of the three years for Phase 2 of the study. Half of these patients will be assigned to the~     Clinic Training Group, while the other half will be assigned to At-home Training Group. For~     all patients, three assessments will be taken: at baseline, after 1 month, and after 2 months~     of training.~      The investigators will compare reading outcomes to assess the roles of feedback versus the~     role of frequent available practice. Because of the extensive cost and clinical resources~     required for vision rehabilitation, it is critical to determine whether the training program~     can be made less expensive, but as effective, when it is self-trained. If the investigators~     demonstrate the utility of at-home practice, clinical facilities and therapists' time can be~     made available for those activities requiring face-to-face contact~   "
130904|NCT01853917|"~     The purpose of this study is to evaluate why the majority of HIV infected women in the Harris~     County Health District system who are pregnant do not come to clinic for their HIV disease~     after they have a baby through questionaires administered prepartum and questionaires and~     structured interviews postpartum. The study will ask subjects questions about HIV, drug use,~     depression and social problems.~   "
130905|NCT01853904|"~     Bronchoalveolar lavage (BAL) is a common technique among pulmonologists. Its goal is to~     collect cells from alveolar units. This is done by wedging a flexible bronchoscope in a~     bronchus, instilling saline, and removing the saline via suction. Two techniques are~     currently used for suctioning: syringe based and channel suction.~      The investigators concern is that channel suction creates too much force and there is~     collapsing of the airways which results in decreased fluid removal as well as cell sampling.~     The investigators propose that syringe based suctioning will not only return more of the~     instilled fluid but also more cells from the alveoli.~   "
130906|NCT01853891|"~     With the advent of electricity, light at night has become a ubiquitous part of our society.~      The main purpose of this study is to determine whether sleeping with dim light (40 lux), the~     brightness of a night light) in your bedroom for 5 consecutive nights will result in~     increased markers of inflammation in the blood compared to sleeping in darkness during the~     night in patients with obstructive sleep apnea (OSA).~      A secondary aim is to examine the effects on insulin sensitivity, other blood proteins, and~     RNA molecules as a result of sleeping with dim light. RNA molecules are substances in blood~     that dictate what type of proteins the body should make.~   "
130907|NCT01853878|"~     The purpose of this study was to test a potential new kind of anti-cancer treatment, called~     PRAME immunotherapy in resected patients with lung cancer.~      As of 18 July 2014, the recruitment was stopped prematurely and the study was unblinded. Only~     patients on active treatment will have the option to continue in the study. Patients~     randomised to the Placebo group were withdrawn.~      There will no longer be an active follow-up of patients after discontinuation or completion~     of the treatment. The study will end 30 days after the last dose will be administered.~      As a result, primary and secondary objectives will not be assessed as planned. All clinical~     and safety data collected in the study will be analysed descriptively. For each biological~     sample already collected in the scope of this study and not tested yet, testing will not be~     performed by default, except if a scientific rationale remains relevant despite the premature~     termination of the study.~   "
130908|NCT01853865|"~     The present study is conducted, to elucidate the value of follow-up examinations in~     endometrial cancer patients. Specifically the objective is to compare hospital-based~     follow-up examinations with instruction in self-referral in stage I endometrial cancer~     patients.~      The investigators hypothesize that the intervention, instruction in self-referral, will:~        -  reduce fear of recurrence~        -  improve quality of life~        -  improve cost-utility~        -  not affect disease-free survival.~   "
130909|NCT01853852|"~     GR181413A/AT1001 (migalastat hydrochloride) is a low molecular weight iminosugar, an analog~     of the terminal galactose group that is cleaved from the substrate GL-3. This compound was~     researched and developed as a drug for treatment of Fabry disease. This study, MGM115806,~     will be the first administration of GR181413A/AT1001 to Japanese subjects to investigate the~     safety, tolerability and pharmacokinetics of single oral doses in healthy Japanese adult~     subjects. Approximately 12 subjects will receive three treatments of 50, 150 and 450 mg~     GR181413A/AT1001 under fasted conditions plus placebo in a dose ascending crossover design.~     Serial pharmacokinetic samples will be collected and safety assessments will be performed~     following each dose. The pharmacokinetics and dose proportionality of GR181413A/AT1001 after~     single oral doses of GR181413A/AT1001 at the dose levels of 50, 150 and 450 mg under fasted~     conditions will be assessed.~   "
132759|NCT01829594|"~     The aim of is to test the effects of a model for care (case management) to older people with~     high healthcare consumption and functional dependency on healthcare consumption, quality of~     life, functional ability and experiences of care.~   "
130912|NCT01853813|"~     Bevacizumab in combination with chemotherapy represents a standard of care for first-line~     treatment in patients with advanced colorectal cancer. Molecular predictive factors for~     bevacizumab efficacy have not yet been identified therefore selection of patients more likely~     to benefit from such a treatment approach is not possible. Retrospective analyses suggested~     that LDH serum levels may influence the clinical activity of anti-angiogenetic drugs. Primary~     aim of our clinical trial will be to prospectively ascertain whether bevacizumab in~     combination with chemotherapy has an improved clinical activity in patients with high LDH~     serum levels compared to patients with normal LDH serum levels~   "
130913|NCT01853800|"~     Rivaroxaban is a substance developed for use in the treatment of blood coagulation disorders.~     Thrombosis (blood clots) can occur as a result of excessive coagulation activity in the blood~     vessels. Excessive coagulation activity can occur in children as well, and rivaroxaban is~     therefore being developed for the treatment of thromboembolic events in children and~     adolescents. As small children are often unable to swallow tablets, an oral suspension~     (mixture of a liquid containing finely distributed solids) has been developed which allows~     dosing according to body weight. The objective of this trial is to compare the~     bioavailability (proportion of a substance that remains available unchanged in the blood~     circulation) of a rivaroxaban oral solution with that of the rivaroxaban tablet approved for~     treatment. In order to evaluate the potential influence of food, the oral suspension~     containing 20 mg rivaroxaban will be taken after consuming food. In addition, the~     pharmacokinetics (concentrations of the drug and breakdown products (metabolites) in blood),~     safety and tolerability will be assessed.~   "
130914|NCT01853787|"~     -  Among many other causes, Bronchial obstruction in Chronic Obstructive Pulmonary Disease~          (COPD) is also caused by inflammation of peripheral airways walls.~        -  Neutrophils and other inflammatory mediators like Interleukin-6 (IL6), Interleukin-8~          (IL8), Interleukin-1 alpha (IL-1 alpha),Interleukin-1beta (IL-1 beta), Tumor Necrosis~          Factor alfa (TNF-alfa), Reactive Oxygen Species (ROS), Leukotriene B4 (LTB4), Nitric~          Oxyde (NO) are implicated in the inflammation.~        -  NO is produced in response to physical and chemical stress on bronchial epithelium and~          plays a critical role in small airways remodelling~        -  Exhaled NO concentration is usually used to monitor bronchial inflammation~        -  The relationship between stretch and strain of small airways and bronchial inflammation~          is not well understood.~        -  The investigators hypothesis is that cyclic opening and closure of peripheral obstructed~          airways through the consequent stretching and strain acting on them can provoke an~          inflammatory response which can be monitored by exhaled NO.~        -  The pharmacological effects of bronchodilators may play a role on bronchial inflammation~          by reducing the stretching stress on bronchiolar walls thus reducing the production of~          NO in exhalate~        -  Data about these physiopathological aspects is missing in literature.~   "
130915|NCT01853774|"~     The purpose of this study is to test the effectiveness of a two-phase intervention using~     community-to-clinic navigators to guide individuals from an especially hard-to-reach,~     multicultural, and underinsured population into primary care clinics and, subsequently, to~     track effects of the intervention on completion of colorectal cancer (CRC) screening in~     clinics. A cost-effectiveness analysis will lay the foundation for further implementation and~     dissemination research.~      Aim 1: Test effectiveness of community group education + tailored navigation versus community~     group education only in increasing clinic attendance among low-income, multicultural Arizona~     residents, aged 50 to 75 yrs.~      Hypothesis 1: Individuals receiving group education classes + tailored navigation will show~     higher rates of clinic attendance than those receiving only group education.~      * As a separate critical step for those who make clinic appointments, the investigators will~     examine the effect on follow through to screening, using initial group assignment as a~     control variable in analysis. Patients making clinic appointments will receive referral for~     screening and tailored navigation as usual care.~      Aim 2: Track outcomes of the Phase I intervention on CRC screening test completion among~     low-income, multicultural Arizona residents aged 50 to 75 years who attend clinic.~      Hypothesis 2: Individuals receiving group classes and tailored navigation during Phase I will~     have higher rates of CRC screening test completion than those receiving classes only,~     (however this outcome will be primarily due to clinic attendance).~      Aim 3: Determine the cost-effectiveness of each phase of the interventions on increasing CRC~     screening completion among low-income, multicultural Arizona residents aged 50 to 75 years.~      Exploratory Aim 4: Examine the levels of program dissemination from community to clinic to~     final screenings using the RE-AIM model.~      Research Question 2: What is the degree of Reach, Efficacy, Adoption, Implementation, and~     Maintenance of the community-to-clinic navigation, and clinic-to-screening outcomes?~   "
130916|NCT01853761|"~     The purpose of this study was to analyze microcurrent short and long term effects used with~     aerobic exercise on abdominal fat.~   "
130917|NCT01853748|"~     This research study is a Phase II clinical trial. Phase II clinical trials test the~     effectiveness of an investigational drug to learn whether the drug works in treating a~     specific cancer. Investigational means that the drug is still being studied and that~     research doctors are trying to find out more about it-such as the safest dose to use, the~     side effects it may cause, and if the drug is effective for treating different types of~     cancer. It also means that the FDA has not approved this drug for use patients undergoing~     adjuvant treatment for HER2+ breast cancer. Trastuzumab emtansine (T-DM1) is a drug that may~     stop cancer cells from growing. This drug has been used in other research studies and~     information from those other research studies suggests that this drug may help to prevent the~     recurrence of breast cancer in this research study.~      The use of T-DM1 in this research study is experimental, which means it is not approved by~     any regulatory authority for the adjuvant treatment of HER2-positive breast cancer. However,~     it FDA-approved for metastatic HER2-positive breast cancer. T-DM1 has caused cancer cells to~     die in laboratory studies. In preclinical studies, this drug has prevented or slowed the~     growth of breast cancer. The breast cancer treatments (paclitaxel and Trastuzumab) used in~     this study are considered part of standard-of-care regimens in early breast cancer. A~     standard treatment means that this is a treatment that would be accepted by the majority of~     the medical community as a suitable treatment for your type of breast cancer.~      In this research study, the investigators are looking to see if the study drug T-DM1 will~     have less side effects than traditional HER2-positive breast cancer treatment of trastuzumab~     and paclitaxel. The investigators are also hoping to learn about the long term benefits and~     disease-free survival of participants who take the study drug T-DM1 in comparison to those~     participants to take the combination of trastuzumab and paclitaxel.~   "
130918|NCT01853735|"~     The purpose of this study is to determine if Enteral Feeding (EN) in patients with a~     traumatic bowel injury requiring an open abdomen impacts outcomes. Patients who receive EN~     will be compared to those who remain nil-per-os (NPO). Additionally, an internal study~     control will be performed by analyzing concurrent injured patients requiring an open abdomen~     who did not have a bowel injury.~      Specific aims:~      Hypothesis 1: EN in patients with a traumatic bowel injury requiring an open abdomen improves~     fascial closure rate compared to patients who remain NPO.~      Hypothesis 2: EN in patients with a traumatic bowel injury requiring an open abdomen reduces~     infectious complications compared to patients who remain NPO.~      Hypothesis 3: EN in patients with a traumatic bowel injury requiring an open abdomen have a~     lower mortality rate compared to patients who remain NPO.~   "
130919|NCT01853722|"~     This proof-of-concept study evaluates the clinical efficacy and safety of DCN01 in prepping~     of the periocular region.~   "
131013|NCT01852500|"~     Results from previous studies suggest the association between Osteopathic Manipulative~     Treatment (OMT) and length of stay (LOS) reduction in a population of preterm infants.~      The primary objective of the present study is to evaluate the effectiveness of sham OMT in~     reducing LOS in a sample of preterm newborns, in order to investigate whether previous~     clinical results could be related to a hypothetical placebo effect.~   "
130920|NCT01853709|"~     Colonoscopy is the gold standard diagnostic procedure for colonic disease. Excellent bowel~     cleansing is critical for this procedure. However, an inadequate bowel cleansing is a common~     problem that occurs up to 20% of procedures. This fact has a deep clinical and economical~     impact. In fact, inadequate bowel preparation is associated to misdiagnosis in 30% of~     lesions. Moreover several clinical conditions such as cirrhosis, antidepressant drugs, and~     hospitalized patients are predictive factors of inadequate colonic preparations. These~     circumstances have promoted multiple clinical trials, however there is no consensus about the~     optimal strategy for colonic cleansing. Education in colonic preparation has obtained~     conflicting results. Polyethylene glycol (PEG) and sodium phosphate solutions have been the~     commonest preparations used with a similar efficacy. However, the large volume to ingest (4~     litters) makes PEG compliance difficult. Likewise, sodium phosphate also contains high levels~     in sodium and phosphate which contraindicate its use in elderly patients and / or with~     comorbidity. The use of adjuvants such as olive oil and bisacodyl allows reducing the volume~     of polyethylene glycol thereby improving the tolerance and right colon preparation.~      The aim of this study is to compare the efficacy of a multidisciplinary approach (education,~     fiber free diet, polyethylene glycol (PEG) 2L, and adjuvant bisacodyl + olive oil) vs. a~     conventional approach (fiber free diet+ PEG 4L in split doses ) in cleaning the colon of~     hospitalized patients.~   "
130921|NCT01853696|"~     Graft rejection has traditionally been one of the leading causes of cornea transplant~     failure. To help prevent rejection, corticosteroid eye drops are used for an extended period~     after transplant surgery. The purpose of this study is to compare the efficacy and side~     effects of different corticosteroid dosing regimens after endothelial keratoplasty (cornea~     transplant) surgery.~   "
130922|NCT01853683|"~     Appendicitis is one of the most common surgical problems in children, with 20-35% of patients~     having perforated by the time they present to a doctor. In these cases, the patient is often~     treated non-surgically with antibiotics. Once a patient has improved, it is not known whether~     it is better to perform an interval appendectomy (IA) or to continue a watchful waiting~     approach. The purpose of this trial is to determine if expectant nonoperative management~     (watchful waiting) is not inferior compared to IA management after successful conservative~     treatment of appendiceal mass at admission.~   "
130923|NCT01853670|"~     The purpose of this study is to determine the utility of kilovoltage (kV) cone beam CT~     imaging to track the dose delivered in head and neck cancer patients, to assess the benefit~     of cone beam CT to patients set-up for radiation treatment, to determine how shifts based on~     kV cone beam CT compare to the standard approach (orthogonal pair), and to develop remote~     access tools (preferably internet-based) so that the MD can approve these plans in real time.~   "
130924|NCT01853657|"~     The main objective is to access efficacy of first and second line antiretroviral therapy~     (ART) and its determinants in patients treated at the Komfo Anokye Teaching Hospital in~     Kumasi (KATH), Ghana, and to compare the clinical, virological and immunological efficacy of~     second line ART in patients who were switched after virological failure compared to patients~     who were switched after clinical or immunological failure.~      Other specific study objectives are:~        1. To establish an HIV Cohort Study at the study site.~        2. To assess the rate of virological failure among patients on first line therapy~        3. To compare the clinical, immunological and virological efficacy of second line~          antiretroviral therapy amongst patients randomised to virological monitoring whilst on~          first line compared with those monitored routinely using clinical and immunological~          monitoring.~        4. To assess the incidence and outcome of tuberculosis (TB) and other opportunistic~          infections in patients treated at the Komfo Anokye Teaching Hospital HIV services~        5. To obtain parameters for quality of care, e. g. performance of TB screening procedures~        6. To develop strategies to minimise treatment failures, on the basis of the results of the~          study~        7. To generate a large prospective second-line ART cohort, to serve as basis for further~          research projects~        8. To implement point-of-care viral load analysis at the Komfo Anokye Teaching Hospital~        9. Capacity building: epidemiology, medical documentation and data base management.~          Enrollment of one PhD and one Master student~   "
130925|NCT01853644|"~     This phase II trial studies how well tivozanib works in treating patients with recurrent~     ovarian, fallopian tube, or primary peritoneal cancer. Tivozanib may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth.~   "
130926|NCT01853631|"~     Subjects on this study have a type of lymph gland cancer called Non-Hodgkin Lymphoma, acute~     lymphocytic leukemia, or chronic Lymphocytic Leukemia (these diseases will be referred to as~     lymphoma or leukemia). The lymphoma or leukemia has come back or has not gone away after~     treatment.~      The body has different ways of fighting infection and disease. No one way seems perfect for~     fighting cancers. This research study combines two different ways of fighting disease,~     antibodies and T cells, hoping that they will work together. Both antibodies and T cells have~     been used to treat patients with cancer. They have shown promise, but have not been strong~     enough to cure most patients.~      T cells can kill tumor cells but normally there are not enough of them to kill all the tumor~     cells. Some researchers have taken T cells from a person's blood, grown more of them in the~     laboratory and then given them back to the person.~      The antibody used in this study is called anti-CD19. It first came from mice that have~     developed immunity to human lymphoma. This antibody sticks to lymphoma cells because of a~     substance on the outside of these cells called CD19. CD19 antibodies have been used to treat~     people with lymphoma and leukemia. For this study, anti-CD19 has been changed so that instead~     of floating free in the blood it is now joined to the T cells. When an antibody is joined to~     a T cell in this way it is called a chimeric receptor.~      In the laboratory, the investigators found that T cells work better if they also add proteins~     that stimulate T cells, such as one called CD28. Adding the CD28 makes the cells last longer~     in the body but not long enough for them to be able to kill the lymphoma cells. The~     investigators believe that if they add an extra stimulating protein, called CD137, the cells~     will have a better chance of killing the lymphoma cells.~      The investigators are going to see if this is true by putting the CD19 chimeric receptor with~     CD28 alone into half of the cells and the CD19 chimeric receptor with CD28 and CD137 into the~     other half of the cells. These CD19 chimeric receptor T cells with CD28 and with or without~     CD137 are investigational products not approved by the FDA.~      The purpose of this study is to find the biggest dose of chimeric T cells that is safe, to~     see how long the T cell with each sort of chimeric receptor lasts, to learn what the side~     effects are and to see whether this therapy might help people with lymphoma or leukemia.~   "
130936|NCT01853501|"~     The purpose of this study is to determine whether Adipose Derived Stem Cells are effective in~     the treatment of Premature Ovarian Failure (POF). Stem cell transplantation has been reported~     to rescue ovarian function in a pre-clinical mouse model of chemotherapy-induced POF;~     however, maintaining the survival of transplanted cells in human ovarian tissues to enable~     the POF patients regain ovary function over the long-term and achieving a successful~     pregnancy remain a troublesome issue. In this study the investigators are aiming to determine~     whether the CD29+/CD44+ human Adipose Derived Stem Cells could later enable ovaries produce~     mature oocytes.~   "
130927|NCT01853618|"~     Background:~      - Tremelimumab is a cancer treatment drug that helps the immune system recognize and destroy~     cancer cells. Researchers want to see if it can be used to treat advanced liver cancer. The~     drug will be given with one of two types of treatment for liver cancer. The first type,~     transarterial catheter chemoembolization (TACE), injects chemotherapy drugs into the tumor~     through the main blood vessel that is feeding it. That blood vessel is then closed off to~     help keep the drugs in the tumor longer. The second type, radiofrequency ablation (RFA), uses~     a heated probe to destroy the tumor tissue. Researchers want to study how safe and effective~     these treatments are with the study drug.~      Objectives:~      - To test the safety and effectiveness of Tremelimumab with TACE or RFA for advanced liver~     cancer.~      Eligibility:~      - Individuals at least 18 years of age who have advanced liver cancer that has not responded~     to other treatments.~   "
130928|NCT01853605|"~     Post-approval study of the safety and effectiveness of NATRELLE® 410 Highly Cohesive~     Anatomically Shaped Silicone-Filled Breast Implants (Styles 410 FM, FF, MM, or MF) for breast~     augmentation, reconstruction, or revision~   "
130929|NCT01853592|"~     Background:~      - Magnetic resonance imaging (MRI) is type of imaging study that uses magnetic fields and~     radio waves to take pictures of the body. To help the images show up more clearly, a contrast~     agent is injected into a vein. Researchers are interested in finding contrast agents that can~     help show problems with the blood vessels around the heart. They want to test an agent called~     Gadofosveset Trisodium to see how it works in MRI scans.~      Objectives:~      - To test the effectiveness of Gadofosveset Trisodium as a contrast agent in heart MRI scans.~      Eligibility:~      - Healthy volunteers between 18 and 45 years of age.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will~          provide blood samples before the scanning sessions.~        -  Participants will have an MRI scan after the screening visit. They will have a dose of~          the contrast scan before the study.~        -  Participants will return for one additional MRI scan within 1 to 2 months of each scan.~          Different doses of the contrast agent will be used for each scan.~        -  An additional blood sample will be collected within 1 week of the second MRI scan.~   "
130930|NCT01853579|"~     Mild thyroid failure is a common condition among older adults and has been associated with~     numerous adverse effects on health, such as cardiovascular disease, cognition disturbances~     and muscular problems. Mild thyroid failure has also been associated with an increased risk~     of developing depression. To date, only few studies have investigated the effect of thyroid~     hormone replacement on depression in patients with mild thyroid failure. This study therefore~     aims to assess whether thyroid hormone replacement in older adults with mild thyroid failure~     is associated with a decrease in the presence of depressive symptoms. This study forms a~     substudy of a large international study on thyroid hormone replacement in older adults with~     mild thyroid failure (the TRUST study).~   "
130931|NCT01853566|"~     The growth hormone (GH) secretion declines gradually with age, with studies demonstrating a~     progressive reduction of 14% secretion per decade of life beginning in the second decade.~     Other studies suggest a disruption in GH secretion in elderly people. These findings suggest~     a possible association between growth hormone deficiency (GHD) and the ageing process.GH~     replacement is well known to improve body composition, leading to a decrease in total body~     fat and an increase in lean body mass. However, GH replacement has only shown an effect on~     muscle strength in GH-deficient adults subjected to long-term GH therapy. Few studies have~     evaluated the effect of GH replacement on muscle strength in elderly people engaged in a~     program of exercise training.Our purpose is to evaluate the effect of GH therapy on muscle~     strength in healthy, non-sedentary men over 50 years old.~   "
130932|NCT01853553|"~     The proposed research will determine the effectiveness of blocking aldosterone for improving~     the health and function of arteries in patients with autosomal dominant polycystic kidney~     disease (ADPKD). The study also will provide insight into how blocking aldosterone improves~     artery health by determining the physiological mechanisms (biological reasons) involved.~     Overall, the proposed research will provide important new scientific evidence upon which~     physicians can base recommendations to patients with ADPKD to decrease risk of developing~     cardiovascular diseases.~   "
130933|NCT01853540|"~     Background:~        -  Pulmonary nontuberculous mycobacterial (PNTM) infection is caused by a common type of~          bacteria in the environment. Although PNTM infection is most common in people with lung~          diseases, it can also affect healthy people. It can be difficult to treat, and affects~          parts of the body other than the lungs. For example, PNTM may affect the cilia, the~          hair-like structures inside the nose and lungs that help move dirt and debris out of the~          body.~        -  Ciliary beat frequency (CBF) is a measurement of how fast cilia move. People with PNTM~          infection have a lower CBF than healthy people. Nitric oxide (NO) is a gas in the body~          that may affect CBF. People with PNTM infection produce lower amounts of NO in their~          noses than healthy people. Researchers want to see if a drug called sildenafil can~          increase NO production and CBF. If sildenafil can improve these measurements, it may be~          a useful treatment for PNTM infection.~      Objectives:~      - To study the effect of sildenafil on CBF and NO levels in people with PNTM infection.~      Eligibility:~        -  Individuals at least 18 years of age who have PNTM infection.~        -  Participants must be enrolled in a related National Institutes of Health study on~          bacterial infections. The study is Natural History, Genetics, Phenotype and Treatment of~          Mycobacterial Infections.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          have heart and lung function tests, as well as tests of NO production in the nose. They~          will provide samples of sputum and cells from inside the nose.~        -  Before the first study visit, participants will collect sputum samples for 24 hours.~          They will bring the samples to the study visit.~        -  At the first study visit, participants will have heart and lung function tests, as well~          as tests of NO production in the nose. They will provide blood, urine, sputum, and nasal~          cell samples. They will also receive sildenafil tablets to take at home.~        -  Participants will take sildenafil tablets three times a day.~        -  The second study visit will be 7 days after the first one. The tests from the first~          visit will be repeated. Participants will receive more sildenafil tablets to take on the~          same schedule as before.~        -  The third and final study visit will be 30 days after the first one. The tests from the~          first visit will be repeated. Participants will stop taking sildenafil at this visit.~        -  A follow-up phone call will be made about 2 weeks after the final study visit. This call~          will ask questions about quality of life and any symptoms or side effects of the study.~   "
130934|NCT01853527|"~     The aim of the study is to assess presence of myocardial ischemia by contrast stress~     echocardiography in patients with symptomatic non-obstructive coronary artery disease (CAD)~     by CT-coronary angiography, and the clinical, vascular, biochemical and genetic markers of~     myocardial ischemia in such patients.~   "
130935|NCT01853514|"~     Primary objective is to determine the impact of messages related to conventionally grown and~     organically grown produce on purchasing behaviors in low-income individuals.~      Secondary objective is to assess knowledge and attitudes about conventionally and organically~     grown fruit and vegetable in low-income individuals.~   "
130957|NCT01853228|"~     The purpose of this study is to examine the safety and efficacy of decitabine in sequential~     administration with cytarabine in children with relapsed or refractory acute myeloid leukemia~     (AML).~   "
130958|NCT01853215|"~     This study is being done to evaluate intraosseous vascular access through the sternum.~   "
130937|NCT01853488|"~     Background:~      After a traumatic spinal cord injury, a severe bone loss in the paralyzed extremities is~     observed. This leads to a osteoporosis which is connected to a high fracture risk.~      Aims:~      To compare the two measurement methods DEXA and pQCT concerning optimal diagnostics and~     assessment of fracture risk in subjects with spinal cord injury.~      Subjects:~      250 women and 250 men (age≥18, any AIS-classification) with an acute or chronic spinal cord~     injury will be recruited for this study. For a reference group, 500 able-bodied persons will~     be measured analogously.~      Methods:~      Using DEXA-Osteodensitometry, bone parameters of the lumbar vertebral column, proximal femur,~     distal radius, distal tibia and knee area will be assessed. Additionally, geometric bone~     parameters of the tibia will be measured by using pQCT. All measurements will be done~     unilaterally. For the assessment of potential risk factors for reduced bone stiffness after~     spinal cord injury a questionnaire will be used.~   "
130938|NCT01853475|"~     Piperaquine tablets (coated) + OZ439 granules + TPGS granules will be co-administered in~     Phase IIb (adults). However, safety and PK data (for OZ439 plus piperaquine) were obtained~     using piperaquine tablets plus OZ439 as Powder in Bottle with milk. Piperaquine has not yet~     been administered together with TPGS. Co-administration of piperaquine plus OZ439 as Powder~     in Bottle (PIB) with milk results in an increase in OZ439 exposure (current estimate ~ 70%~     due to a small drug drug interaction).~      This study investigates the exposure of piperaquine and OZ439 when co-administered as~     piperaquine phosphate tablets and OZ439 + TPGS prototype (a formulation close to that of~     Phase IIb, but not identical), in order to select the appropriate doses for Phase IIb. The~     reference treatment is piperaquine phosphate tablets + OZ439 Powder in Bottle + full fat milk~   "
130939|NCT01853462|"~     The purpose of this study is to determine the comparative effectiveness of proprioceptive~     neuromuscular facilitation and balance exercise programs for the rehabilitation of ankle~     sprain injuries.~   "
130940|NCT01853449|"~     Dyspnea refers to the awareness of breathing discomfort that is typically experienced~     during exercise in health and disease. In various participant populations, dyspnea is a~     predictor of disability and death; and contributes to exercise intolerance and an adverse~     health-related quality-of-life. It follows that alleviating dyspnea and improving exercise~     tolerance are among the principal goals of disease management. Nevertheless, the effective~     management of dyspnea and activity-limitation remains an elusive goal for many healthcare~     providers and current strategies aimed at reversing the underlying chronic disease are only~     partially successful in this regard. Thus, research aimed at identifying dyspnea-specific~     medications to complement existing therapies for the management of exertional symptoms is~     timely and clinically relevant. The purpose of this study is to test the hypothesis that~     single-dose inhalation of fentanyl citrate (a mu-opioid receptor antagonist) will improve the~     perception of dyspnea during strenuous exercise in healthy, young men in the presence of an~     external thoracic restriction. To this end, the investigators plan compare the effects of~     inhaled 0.9% saline placebo and inhaled fentanyl citrate (250 mcg) on detailed assessments of~     neural respiratory drive (diaphragm EMG), ventilation, breathing pattern, dynamic operating~     lung volumes, contractile respiratory muscle function, cardio-metabolic function and dyspnea~     (sensory intensity and affective responses) during symptom-limited, high-intensity,~     constant-work-rate cycle exercise testing with and without external thoracic restriction in~     healthy, men aged 20-40 years.~   "
130941|NCT01853436|"~     The objective of this study is to demonstrate that acellular dermal matrix, Strattice™~     Reconstructive Tissue Matrix, can reduce the surgical complexity and post-operative pain of~     breast reconstructions with implants by avoiding one more surgical step in the operating~     room.~   "
130942|NCT01853423|"~     The objective of this study is to evaluate the safety and efficacy of a 0.1% formulation of~     rapamune cream in children with Tuberous Sclerosis Complex (TSC), ages 3 years and older, who~     have facial angiofibromas that would benefit from treatment.~   "
130943|NCT01853410|"~     The purpose of the PERCCAD Study is to investigate the effect of the gekoTM device (a~     non-invasive calf muscle stimulator approved for use to improve blood flow by Health Canada)~     on coronary blood flow in order to assess its potential role as a therapeutic modality for~     the treatment of symptomatic coronary artery disease (CAD). This will occur in patients~     already undergoing coronary angiography and percutaneous coronary intervention (PCI) as part~     of their usual medical care. Further, the investigators will also assess the overall effect~     on blood flow in the body using non-invasive techniques. The primary objective of the PERCCAD~     study is to assess the effect of the gekoTM device on coronary blood flow in patients with~     symptomatic CAD who are undergoing invasive angiographic assessment and management with PCI.~     This evaluation of the gekoTM device is to be performed at the time of the patient's already~     planned invasive assessment and management so that invasive data can be collected without~     exposing the patient to risks other than those already associated with their planned~     procedure and usual clinical care. The secondary objective of the study is to assess the~     effect of muscle stimulation with the gekoTM device on endothelial function and peripheral~     blood flow measured via non-invasive techniques.~   "
130944|NCT01853397|"~     The purpose of this study is to evaluate the safety, efficacy, and tolerability of treatment~     with the Liposonix System (Model 2)using a single pass technique.~   "
130945|NCT01853384|"~     This study is being done to find out if an investigational product called HP802-247 can help~     people with venous leg ulcers. Investigational means that HP802-247 has not been approved by~     the U.S. Food and Drug Administration (FDA).~      This research is being done to compare the efficacy of HP802-247 plus compression therapy~     against Vehicle plus compression therapy in achieving complete wound closure over the 12-week~     treatment period. Vehicle looks the same as HP802-247 but contains no cells.~      At least 440 subjects will participate. The study is going to be conducted in approximately 5~     countries at approximately 50 sites across the European Union.~   "
130959|NCT01853202|"~     Patients with lymphoma or cancer who are receiving chemotherapy in the outpatient setting are~     at risk for blood clots which form in the veins. The occurrence of blood clots has major~     implications on personal health including the need for blood thinners and monitoring,~     potential bleeding, and complications related to blood clots on cardiovascular health. The~     goal of this study is to determine whether aerobic exercise training is a therapeutic~     strategy to offset risk of blood clots and improve quality of life among cancer patients~     during chemotherapy.~   "
130946|NCT01853371|"~     This research proposal is submitted to fulfill the requirement of the PHD degree of Community~     Medicine Saudi Board at the Joint Program of Family and Community Medicine in Jeddah, Saudi~     Arabia.~      Background: Cupping is an ancient treatment remedy that has been used for many centuries in~     many parts of the world. In the Middle East, Wet cupping Hijama is still a popular~     treatment because of its religious background. Despite of that, it still has little~     scientific evidence that proves its efficacy. Many hijama healers claim that they have~     observed dramatic improvement in Blood pressure control of hypertension patients. Not many~     studies support that. This study should help to prove or disprove this hypothesis.~      Objectives:~        -  To determine the efficacy of wet cupping on blood pressure among high blood pressure~          patients.~        -  To assess the incidence of wet cupping side effects in the intervention group.~      Methods: The study design is a randomised controlled trial. There will be an intervention~     group of high blood pressure patients who will perform hijama in addition to their usual~     management, and a control group of high blood pressure patients who will receive their usual~     anti-hypertension management only. There will be 4 weeks follow up period. After that, data~     entry, analysis and interpretation will take place.~      Hypothesis: Wet cupping has an effect on blood pressure in adult hypertension patients~   "
130947|NCT01853358|"~     The goal of our study will be to determine the clinical and biological safety of infusing~     immuno-selected NK (Natural Killer) CD3-/CD56+ cells, early after allogeneic transplantation~     with colony stimulating factor (G-CSF) mobilized peripheral blood stem cells and Reduced~     Intensity Conditioning (RIC), as a potential substitute to usual Donor Lymphocyte Infusion~     (DLI), that contain the whole range of immune effectors. The trial will include several~     progressive steps: dose escalation up to a level compatible with the cost-effectiveness~     potential of the device and clinical situation and recombinant interleukin-2 (r-IL2)~     activation of selected NK cells in vitro prior to re-infusion.~   "
130948|NCT01853345|"~     In this study tumor will be tested for cancer causing gene alterations such as mutations or~     copy number alterations. This is called tumor profiling. A panel of experts will review the~     tumor profiling results and determine whether there is a cancer-causing alteration present in~     the tumor. If there is, the experts will determine if there is a targeted drug available that~     could counteract this alteration. If there is an alteration identified and a targeted drug~     available the panel of experts will make an individualized treatment recommendation. The~     results of the tumor profiling and the individualized treatment recommendation can be shared~     with the primary oncologist.~   "
130949|NCT01853332|"~     The purpose of this study is to determine the effects of individual characteristics, life~     stresses, and relationships over time on psychosocial outcomes (e.g. marriage, parenting,~     work) and physical health~   "
130950|NCT01853319|"~     This is an open-label phase III study of regorafenib in patients with metastatic colorectal~     cancer (mCRC) who have progressed after all approved standard therapy. The purpose of this~     study is to provide additional information about the safety profile of Regorafenib.~   "
130951|NCT01853306|"~     This is a 3 part phase 1 study to evaluate the safety, pharmacokinetic and oral~     bioavailability of veliparib in subjects with solid tumors.~   "
130952|NCT01853293|"~     This research is designed to assess if problem drinking by treatment seeking individuals can~     be treated (reduced) by kudzu extract pharmacotherapy plus medical management therapy.~   "
130953|NCT01853280|"~     This pilot study seeks to evaluate initial evidence for the effect of L-methylfolate~     supplementation to OROS-Methylphenidate pharmacotherapy on ADHD symptoms and associated~     features in adults with ADHD, as well as tolerability of this supplementation. The~     investigators will conduct a 12-week double-blind randomized placebo-controlled trial with~     L-methylfolate supplementing open-label OROS-Methylphenidate (OROS-MPH). The investigators~     propose to examine 40 adult (ages 18-55) subjects satisfying the DSM-IV diagnostic criteria~     for ADHD.~   "
130954|NCT01853267|"~     TITLE Perianal Abscess Packing (PAP): a randomised controlled trial (Pilot study)~      DESIGN Randomised controlled trial.~      HYPOTHESIS In patients with perianal abscesses incision and drainage without packing the~     subsequent cavity will reduce patient discomfort without increasing healing time or~     recurrence compared with management involving cavity packing.~      OUTCOME MEASURES~        -  Length of hospital stay~        -  Time to cavity healing~        -  Recurrent abscess or fistula formation~        -  Pain score~        -  Analgesia usage POPULATION All patients older than 18 years presenting with a perianal~          abscess.~      ELIGIBILITY Exclusion criteria:~        -  under 18 years~        -  those unable to give informed consent~        -  abscesses associated with Crohn's disease or other underlying causes~        -  abscesses in which initial drainage is considered inadequate (if the skin is not open~          sufficiently to allow drainage of the abscess cavity)~      DURATION Until recruitment of subjects is complete~   "
130955|NCT01853254|"~     This open-label, non-randomized, single arm study will provide treatment or re-treatment with~     Pegasys (peginterferon alfa-2a) as monotherapy or in combination with Copegus (ribavirin) to~     patients with chronic hepatitis C infection. Patients who have received prior Pegasys~     monotherapy or combination therapy or who were considered eligible for treatment with Pegasys~     in previous donor protocols will be eligible to participate in this study. Treatment will be~     on investigator's decision according to the approved label for up to 48 weeks, with a 24-week~     safety follow-up.~   "
130956|NCT01853241|"~     The small bowel is poorly suited to standard endoscopy techniques due to its anatomical~     differences from the colon and the upper gastrointestinal tract. The small bowel has an~     average length of 6.7 m, with a free mesentery that resists standard push to advance~     endoscopy techniques. New developments in overtubes, which are placed over an enteroscope,~     have revolutionized doctors ability to deeply intubate the small bowel. Three types of~     'augmented' enteroscopy, double balloon enteroscopy (DBE), single balloon enteroscopy (SBE)~     and spiral enteroscopy (SE), have been developed. Although studies have been performed on~     these individual techniques, there are no studies comparing SBE and SE, the two techniques~     used in Johns Hopkins.~      The investigators propose performing a prospective, randomised trial, to assess the~     differences between these two techniques. The question of what differences there are between~     these two techniques, in terms of depth of insertion, diagnostic and therapeutic yields, time~     required for the procedure and the sedation requirements, are important questions to answer,~     and depending on the results, would affect the investigators approach to patients with small~     bowel disease.~   "
130961|NCT01853176|"~     Background & study question:~      Strategies for post-operative pain control that make use of various different types of~     medicines are advantageous both for patient comfort and for minimizing the use of opioid pain~     medicines and their associated side effects, which include drowsiness, nausea, and vomiting.~     A key element of these strategies is wound injection with local anesthetic (numbing medicine)~     at the time of surgery. Local numbing procedures are used routinely in patients undergoing~     abdominoplasty (tummy tuck), most often with lidocaine or bupivacaine, which can last several~     hours. Multiple studies have shown that locally injected pain medicines achieve better pain~     control, less opioid use, and faster return to normal activities, such that the use of one of~     these local anesthetic medicines is the current standard of care.~      Exparel is an extended-release formulation of bupivacaine that can produce local pain relief~     for up to 72 hours. Studies have shown it to provide better post-operative pain control and~     decreased use of opioid medications when compared to patients who did not receive any local~     numbing agents. Exparel has been used successfully in a variety of surgical settings,~     including open colon surgery, laparoscopic gall bladder removal, abdominoplasty, and breast~     augmentation. Its effectiveness has by and large been established in comparison to no local~     anesthetic. In this study, we seek to investigate the benefit of Exparel compared to standard~     bupivacaine infiltration in patients undergoing abdominoplasty.~      Study design:~      Patients scheduled for abdominoplasty with the lead investigator will be offered inclusion in~     this study. Consenting patients will be randomly assigned to standard bupivacaine or Exparel~     by coin toss after their clinic visit. On the day of surgery, the only difference between~     patients assigned to one arm or the other is the local anesthetic used. The surgery itself~     and plan for general anesthesia will be similar. Both groups will have the same pain~     medicines available after surgery.~      Patients will be given a form on which to record twice-daily pain ratings and opioid narcotic~     needs for 3 days after surgery. For patients admitted after surgery, oral and IV narcotic use~     will be collected from their inpatient medical record.~      The primary outcome of interest is daily and cumulative pain scores through 3 days. A~     secondary endpoint is daily and total opioid use over 3 days. Additional measures include the~     time to first post-operative use of opioid medication and incidence of any adverse side~     effects.~   "
130962|NCT01853163|"~     The purpose of the study is to further investigate the safety of six different commercially~     used Gadolinium-containing contrast agents.~      The study has been developed to evaluate Gadolinium retention in patients with renal function~     ranging from stable to severely impaired renal function who had previously (i.e. before start~     of this study) received any of the six different contrast agents within a magnetic resonance~     contrast imaging procedure and who will now undergo an orthopaedic procedure that allows~     collection of bone and skin samples for analysis.~   "
130963|NCT01853150|"~     Freezing of gait (FOG) means that patients cannot walk without any known causes, other than~     parkinsonism, which is very disabling symptom. Patients descirbe their feeling of the feet~     suddenly being glued to the floor. Transcranial magnetic stiumation is a noninvasive~     procedure using electromagnetic induction to stimulate brain. Transcranial magnetic~     stiumation (rTMS) can selectively change brain activity to enhance desired effects. The aim~     of this study is to the therapeutic effect of rTMS for the FOG.~   "
130964|NCT01853137|"~     The current trial was designed to investigate the possible initial net skeletal and dental~     effects of treatment with FLMGM by a comparative evaluation of treated and untreated Cl II/1~     malocclusion subjects. The null hypothesis stated that there were no significant differences~     in dentofacial changes between FLMGM group and control group.~   "
130965|NCT01853124|"~     The objective of this study is to determine for previously healthy children who present to a~     Canadian Emergency Department (ED) with acute gastroenteritis (infection or irritation of the~     digestive tract); if compared with placebo, the administration of a probiotic agent~     (Lacidofil) will result in a significantly lower proportion of children developing moderate~     to severe disease over the subsequent 2 weeks and will not be associated with a significantly~     greater occurrence of side effects.~   "
130966|NCT01853111|"~     Many patients suffer from devastating injuries to vascularized composite tissues.~     Vascularized composite tissues are blocs of functional tissue that can contain multiple~     tissue types such as bone, muscle, nerves, blood vessels, tendons, ligaments, and others.~     Examples of patients with severe vascularized composite tissue defects include limb amputees,~     patients with third-degree burns to the face or extremities, soldiers with~     improvised-explosive-device blast injuries to the face, and others. These patients cannot be~     helped satisfactorily with conventional reconstructive surgery; however, recently~     vascularized composite allotransplantation (VCA) such as transplantation of faces and limbs~     became available to this patients. Unfortunately, at this juncture, patients who receive VCA~     must submit to life-long regime of immunosuppressant drugs with serious side effects such as~     infection, renal toxicity and cancer. Immune tolerance is the absence of a destructive immune~     response from the recipient's body to the transplant, while otherwise maintaining sufficient~     immune function to fight infections and other threats. Transplant recipients with immune~     tolerance do not need to take immunosuppression drugs. The investigators believe that they~     can achieve immune tolerance in recipients of face and limb transplants.~   "
130967|NCT01853098|"~     The primary objective of this study is a proof-of-concept study to test whether a novel~     mindfulness based intervention, Positive Affect Training (PAT), can enhance positive affect~     and compassion, and decrease negative affect and feelings of depression. PAT involves a~     combination of practicing mindfulness meditation and loving-kindness meditation in groups.~     The goal of the research is to test the initial feasibility and efficacy in increasing~     positive affect and decreasing negative affect in individuals recruited from the general~     community who experience negative affect. If the training proves to be successful, we will~     test the intervention, in additional studies, on individuals with dysthymic disorder and~     other clinical disorders. PAT is a cost-effective, non-invasive intervention. Therefore if~     effective, it could be an alternative or supplemental intervention option to existing~     psychotherapy for dysthymic disorder.~   "
130968|NCT01853085|"~     The study will evaluate patients diagnosed with primary open angle glaucoma or ocular~     hypertension who are switched to Lumigan® UD monotherapy for medical reasons in accordance~     with physician standard clinical practice. All treatment decisions lie with the physician.~   "
130969|NCT01853072|"~     The purpose of this study is to demonstrate superiority of Nepafenac Ophthalmic Suspension,~     0.3% dosed once daily relative to Nepafenac Vehicle based upon clinical outcomes among~     diabetic subjects following cataract surgery.~   "
131014|NCT01852487|"~     Androgenic alopecia is the most common cause of hair loss in men. Finasteride and minoxidil~     are available in treatment of androgenetic alopecia, although the former causes decreased~     libido or ejaculate volume, erectile dysfunction, the latter causes scaling, itching of the~     scalp. Recently, Pulpkin Seed Oil shows some improved clinical efficacy on scalp hair growth~     in men with androgenetic alopecia, but there is no evidence to support this.~      The investigators conducted a randomized, double-blind, placebo-controlled efficacy and~     tolerability trial of Pumpkin seed oil (400mg/day)therapy in male patients with androgenetic~     alopecia.~   "
130970|NCT01853059|"~     Anal cancer is treated with chemoradiotherapy- combined chemotherapy and radiotherapy. This~     is very successful (75% long term survival). During the course of the radiotherapy, other~     organs in the pelvis may be damaged. This can lead to long-term problems with possible~     changes to the skin, bowels with diarrhoea and incontinence problems, bladder shrinkage and~     incontinence of urine, sexual problems including impotence and ejaculatory problems, or pain~     during sexual intercourse with vaginal dryness and shrinkage. Patients should be offered help~     with these side effects. At present, there is very little information on the effect treatment~     has on a patient's quality of life, making it difficult to judge if new treatment methods are~     better.~      This project will measure quality of life from the patient's perspective after treatment for~     anal cancer. It will also gather preliminary data on quality of life after the introduction~     of a new technique for more precise 3D-targeting of radiotherapy beams at the cancer, called~     IMRT.~   "
130971|NCT01853046|"~     To characterize the pharmacokinetics and safety of regorafenib in cancer subjects with severe~     renal impairment when compared to the Control group (cancer subjects with normal or mildly~     impaired renal function)~   "
130972|NCT01853033|"~     The purpose of this study is to assess the safety, tolerability and pharmacokinetics of~     ABT-122 in subjects with Rheumatoid Arthritis.~   "
130973|NCT01853020|"~     The purpose of this study is to characterize the dose-related effects of~     delta-9-tetrahydrocannabinol (∆9-THC) in healthy individuals on cerebellum-dependent motor~     functions.~   "
130974|NCT01853007|"~     The purpose of this study is to test the impact of a newly developed educational program on~     kidney transplant candidates' communication about living and deceased donor kidney~     transplantation.~   "
130975|NCT01852994|"~     The purpose of this study is to determine if exercise training with or without testosterone~     replacement can improve cardiopathy in heart failure patients~   "
130976|NCT01852981|"~     To verify changes in physical activity levels, metabolic markers, and physical fitness as~     results of two physical activity interventions within the Brazilian public health system~     (primary health care).~   "
130977|NCT01852968|"~     The hippocampus is an area of brain which plays an essential role in learning and memory~     processing and is thought to be particularly vulnerable to effects of hypoglycemia (low blood~     glucose). The goal of this project is to examine hippocampal neurochemistry and metabolism~     and identify how diabetes and recurrent hypoglycemia alter the hippocampus.~   "
130978|NCT01852955|"~     Recent evidence demonstrates that perioperative pain continues to be poorly managed among~     ambulatory surgical patients. More importantly, few interventions that minimize postoperative~     pain have also shown to improve patient overall quality of post-surgical recovery. Ketorolac~     has been used to minimize perioperative pain despite the lack of evidence for its use when~     administered as a single dose preventive strategy.Ketorolac has also been associated with a~     higher incidence of perioperative hematomas and the need for surgical re-exploration after~     breast surgery.~      Systemic acetaminophen has become recently available in The United States. In contrast to~     ketorolac, systemic acetaminophen has not been reported to have adverse side effects on~     patients undergoing breast surgery. Although evidence suggests that a single dose~     perioperative acetaminophen reduces postoperative pain, it remains unknown if a single dose~     intravenous acetaminophen improves postoperative quality of recovery after ambulatory~     surgery.~      The main objective of the current investigation is to evaluate the effect of a single dose~     systemic acetaminophen on postoperative quality of recovery after ambulatory breast surgery.~     We also seek to determine if systemic acetaminophen would decrease postoperative pain and the~     time to hospital discharge in the same population.~      Significance: The current project evaluates a potential intervention to improve perioperative~     pain and recovery after ambulatory breast surgery. Postoperative pain in the ambulatory~     surgical patients has been shown consistently to be poorly managed.~   "
130979|NCT01852942|"~     This study was designed to test the hypothesis that treatment of HIV infected subjects with~     losartan, an agent with specific anti-inflammatory and anti-fibrotic actions, will:~        1. reverse existing lymphoid tissue fibrosis,~        2. restore lymphoid tissue architecture,~        3. increase the number and improve the function of peripheral and lymphatic CD4 T cells,~        4. decrease levels of systemic immune activation (IA),~        5. decrease size of the HIV reservoir, and~        6. be safe and well tolerated.~   "
130980|NCT01852929|"~     The purpose of this study is to determine whether obstructive sleep apnea affects sleep~     dependent memory and learning. Subjects with apnea will be given a test of perceptual skill~     learning (the Visual Discrimination Task (VDT)) that has previously been shown to depend on~     sleep. Subjects will be tested on this task before and after sleep. The difference in~     performance after sleep compared to before sleep provides a measure of sleep dependent~     learning. Participants will be tested on one night when they have less apnea because they are~     using continuous positive airway pressure (CPAP) as prescribed by their physician, which is~     well known to reduce apnea; and on another night when they are in their native state and have~     a greater degree of apnea. Memory performance will be compared between the two nights to~     determine how apnea affects sleep dependent memory.~   "
130981|NCT01852916|"~     The purpose of the study is to assess whether nasal high frequency ventilation (NHFV) is~     superior to nasal continuous positive pressure (nCPAP) to prevent tracheal intubation and~     mechanical ventilation in preterm infants less than 28 weeks gestation following first~     attempt at extubation and removal from mechanical ventilation~   "
130982|NCT01852903|"~     The purpose of this study is to compare levels of vitamin C in the blood over the 24 hour~     period following a single 1000 mg dose of vitamin C from ascorbic acid, calcium ascorbate and~     placebo.~   "
130983|NCT01852890|"~     This is a phase 1 (first in man) study testing the safety of adding high dose ascorbate~     (vitamin C) to standard radiation and chemotherapy for treatment of pancreatic cancer.~   "
131015|NCT01852474|"~     In this study, the investigators aim to assess the clinical and neurophysiological effects of~     a non-invasive brain stimulation technique - transcranial direct current stimulation (tDCS)-~     on cortical plasticity and motor learning in children with cerebral palsy. Investigators will~     use different assessment techniques, such as transcranial magnetic stimulation (TMS) and~     kinematics (sensors) to measure changes through the trial.~   "
131016|NCT01852461|"~     Perfusion index may vary according to type of surfactant during the treatment of respiratory~     distress syndrome.~   "
130984|NCT01852877|"~     Aim-1: Evaluate opt-out versus opt-in testing for the human immunodeficiency virus (HIV) at~     the Cook County jail and the Illinois Department of Corrections Northern Intake facilities.~     Outcomes of interest include a) uptake of each HIV testing strategy, b) comparative~     effectiveness of identifying HIV-positive cases, new cases and undisclosed cases, and c)~     predictors of HIV testing.~      Aim-2: Evaluate two case management strategies - correctional case management and~     transitional case management - designed to improve linkage and adherence to appropriate~     medical care after release from incarceration. Correctional case management is a longer-term,~     more intense approach while transitional case management seeks to meet the clients' immediate~     needs, link them to Ryan White case management, and then support the Ryan White case manager~     in assisting these clients. Correctional case management will be compared to the standard of~     care for jail detainees, and to transitional case management for persons leaving prison.~     Outcomes of interest include, (a) HIV viral load and CD4 cell counts over time, (b) adherence~     to medication, and (c) visits to medical providers.~      Aim-3: Evaluate the impact of an incentive for HIV-positive detainees released from jail to~     visit an HIV service organization where they can be linked to medical care and case~     management. Outcomes of interest are essentially the same as Aim-2.~      Aim-4: Assess university-based telemedicine as means to improve care of state prison inmates~     living with HIV. Outcomes of interest include medication regimens, HIV viral load and CD4~     cell counts, and associated health conditions.~      Aim-5: Assess the uptake of partner notification and social network HIV counseling and~     testing involving HIV-positive persons released from jail and prison as a means to extend the~     reach of the 'seek, test, treat and retain' (STTR) model into the community.~   "
130985|NCT01852864|"~     The biological effects of castration on prostate cancers will be studies by administration of~     degarelix prior to radical prostatectomy.~      The effects will be studied by analysis of gene expression and immunohistochemistry focusing~     on markers of proliferation and apoptosis of samples taken at the time of radical~     prostatectomy (7 days after administration of degarelix).~      Tumours from patients treated with neo-adjuvant degarelix will be compared with tumours from~     patients who have not been medically castrated.~   "
130986|NCT01852851|"~     The investigators plan to conduct a randomized controlled trial to evaluate the effectiveness~     and the cost effectiveness of an on-line eLearning program (entitled Employment and~     Arthritis: Making it Work) designed to help people with inflammatory arthritis stay employed.~     The program also includes assessments with 1) an occupational therapist, and 2) a vocational~     rehabilitation counsellor at the end of the program to help participants identify and obtain~     necessary changes at work. People from three provinces will be recruited from collaborators'~     patient and program recipient lists. The study group will receive the program intervention~     and the control group will receive usual care and printed educational material. All~     participants will be followed for five years. The effectiveness of the program at improving~     at work productivity and reducing work cessation will be evaluated compared to a control~     group receiving printed material on employment and arthritis.~   "
130987|NCT01852838|"~     Lung cancer is the most lethal cancer, killing ~1.3 million people worldwide every year.~     Early diagnosis could increase its survival by 3-4 folds. Therefore the yield of screening~     for lung cancer is not a question anymore and the urgent unmet need is to define the group~     that is under a high risk for lung cancer.~      Our lab is focusing on revealing non-invasive biomarkers as for early detection of lung~     cancer. This study specifically focuses on biomarkers that are found in exhaled breath. These~     biomarkers are known as volatile organic compounds (VOCs).The VOCs' profile can discriminate~     between those who suffer from lung cancer and healthy individuals.~      It is well established that a cancer cell can activate their glycolysis (glucose degradation)~     pathway in order to survive. This links malignant processes with this basic biochemical,~     metabolic cycle. This study will focus on the unique processes incurred by glycolysis in the~     tumor cells and its effect on the surrounding environment. By better understanding and~     revealing the exact mechanism, it will become possible to identify the biomarkers released by~     malignant cells that use glycolysis as a source of energy.~      This study's goal is to identify and analyze those distinguishing VOCs. The hope is that~     these VOCs will provide a new innovative possibility of developing the so desperately needed,~     early-detection lung cancer screening method.~      This research will collect and analyze the exhaled breath of participants. The exhaled breath~     will be obtained before and after a glucose challenge test, in which the participant is asked~     to drink a solution containing water and glucose. This study will involve a total of seventy~     participants, fifty of which currently suffer from active lung cancer, while the remaining~     participants belong to a high-risk group.~   "
130988|NCT01852825|"~     The purpose of this study is to assess the effect on various biomarkers of treatment with~     MK-8237 in participants with allergic rhinitis or rhinoconjunctivitis. In Part 1 of the study~     healthy participants undergo nasal allergen challenge (NAC) with house dust mite (HDM)~     extract in order to verify the operational performance of NAC and associated sample~     collection methods. Part 2, the main study, is a placebo controlled, double blind study of~     participants with HDM-induced allergic rhinitis or rhinoconjunctivitis. The primary~     hypotheses are that the changes from baseline in post-allergen challenge HDM-specific~     Immunoglobulin G4 (IgG4) and Immunoglobulin E blocking factor (IgE-BF) are greater after~     treatment with MK-8237 than after treatment with placebo.~   "
130989|NCT01852812|"~     This study will evaluate the safety and pharmacokinetics of montelukast (MK-0476) in the~     treatment of Japanese pediatric participants with perennial allergic rhinitis (PAR). The~     primary hypothesis of this study is that montelukast oral granules (OG) and chewable tablets~     (CT) provide appropriate exposure to montelukast in Japanese pediatric participants with PAR.~   "
130990|NCT01852799|"~     This is a multicentre; single arm study in subjects with newly diagnosed multiple myeloma.~      The primary objectives of this study is to assess the effect of bortezomib combination~     therapy (PAD regimen) followed by ASCT on bone metabolites in patients with newly diagnosed~     multiple myeloma, as measured by ELISA methodology as previously described analyzing the~     change in biochemical bone marker compared with the baseline value: bone formation marker-~     bone alkaline phosphatase(bALP) and osteoblast inhibitor- Dickkopf-1(DKK-1）.~      The secondary objectives of this study are:~        1. Subgroup analysis for the change from baseline in biochemical bone marker based on~          whether or not Bisphosphonate was used.~        2. Assessment of other bone markers parameters: bone formation marker -carboxy terminal~          propeptide of type I procollagen (PICP); bone resorption markers -carboxy terminal~          telopeptide region of type I collagen ( ICTP); osteoclast stimulators~          -osteoprotegerin(OPG), soluble receptor activator of nuclear factor kappaB~          ligand(sRANKL);~        3. To observe the effect of bortezomib on bone mineral density (BMD) as measured by~          repeated quantitative CT-scan;~        4. The evaluation of Skeletal related events (SRE) and appearance of new bone lesions;~        5. To determine progression free survival (PFS), 1 year survival, overall survival and~          safety profile following treatment with PAD and ASCT as first-line therapy.~   "
130991|NCT01852786|"~     The aim- To evaluate the impact of combined oral contraceptives on women's psychosexual,~     metabolic, blood coagulation, hormonal and genetic measures.~      Combined oral contraceptives (COCs) is still the most popular contraception method. It is~     possible to find a number of publications about their non-contraceptive benefits, also about~     their adverse events. Most researches are conducted during clinical trials, which are~     commissioned by pharmaceutical companies, in order to compare COCs of different composition.~     This study set out to assess the role of psychosexual, metabolic, endocrine, hormonal and~     genetic measures of low dose combined oral contraceptive users- 20 micrograms of~     Ethinylestradiol/3 mg of Drospirenone and 20 micrograms of Ethinylestradiol/75 micrograms of~     Gestoden. Because this study is not commercial, it is expected to obtain valuable objective~     data - there are very few comparative studies about the impact of COCs to woman's organism.~   "
130992|NCT01852773|"~     This study aims to increase understanding of the short-term and long-term outcome of blunt~     aortic injury (BAI) and to discern if there is an advantage resulting from the type of~     operative treatment used to manage it, either the classic open surgical repair or a newer~     technique known as thoracic endovascular repair (TEVAR). Specifically, this study will answer~     the following questions regarding patients suffering BAI:~        1. What clinical variables affect short-term mortality and neurologic outcome?~        2. What are the long-term treatment-associated complications of open repair and TEVAR?~        3. In patients with a similar injury and physiologic profile, is there a survival advantage~          resulting from the type of operative treatment?~   "
130993|NCT01852760|"~     In this cross-sectional study patients with active or quiescent ulcerative colitis will be~     studied to determine the utility of endoscopic ultrasound measurements of rectal wall blood~     flow and thickness as reliable indices of disease severity and the degree of correlation that~     exists with validated clinical, endoscopic, and histological indices.~   "
130994|NCT01852747|"~     This study is being done to compare people who had a standard of care spinal fusion using~     part of their local bone graft (a small amount of bone from the region of the spine where the~     fusion is occurring) to correct an adult spinal deformity and people who will have a standard~     of care spinal fusion using a mixture of Actifuse ABX® (a market approved bone graft~     substitute) and a local bone graft (a small amount of bone from the region of the spine where~     the fusion is occurring). This study will compare the outcomes of both groups to help the~     Orthopaedic surgeon conducting spinal fusions in the future. Investigators expect that~     Actifuse ABX® will be as good if not better than just a local bone graft.~   "
130995|NCT01852734|"~     The purpose of this prospective non-randomised study is to examine whether two different~     microspheres (Bead-Block and Embosphere) are equally effective in the treatment of the~     uterine fibroid controlled with contrast-enhanced MR examination.~      Quantitative MR imaging, including dominant fibroid T1, T2 and contrast enhancement~     characteristics before intervention and 3 months after interventions will be analysed as a~     potential predictor of volumetric response after embolization.~      Another purpose is to determine long-term follow-up in all patient treated in a period from~     2001-2011 in OUH analysed retrospectively.~   "
130996|NCT01852721|"~     The purpose of this study is to document differences between men and women (referred here as~     gender differences) in diet adherence and in changes in specific dietary intakes and energy~     density in response to a 12-week nutritional education program promoting the Mediterranean~     diet in both the short term (immediately after the end of the intervention) and longer term~     (3 and 6 months after the end of the intervention). The investigators hypothesize that both~     in the short and the longer term, women will have a better adherence to recommendations~     promoting the Mediterranean diet than men namely because of higher self-determination.~   "
130997|NCT01852708|"~     The purpose of this study is to collect maternal blood samples from pregnant women carrying a~     fetus with a confirmed diagnosis of chromosomal abnormality or genetic disorder including~     microdeletions in order to further develop a non-invasive prenatal screening test based on~     fetal DNA isolated from maternal blood.~   "
130998|NCT01852695|"~     In the highly technological environment of the modern neonatal intensive care unit (NICU),~     the infant is physically, psychologically and emotionally separated from its parents.~     Recognition that this impedes parent- infant interaction and is detrimental to the infant,~     led to the development of programs such as family centered care, kangaroo care and~     skin-to-skin care1-3. However, they are based on the common premise that only NICU~     professionals with special skills can provide care for the infant. Parents are relegated to a~     supportive role, and some have described themselves as voyeurs who are allowed to visit and~     hold their infants4. Many feel anxious and unprepared to care for their infants after~     discharge5.~      In 1979, a shortage of NICU nurses in Estonia prompted Levin1,6 to implement a humane care~     model in which parents provided nursing care for the infant (except for administration of IV~     fluid and medication), while nurses provided teaching and guidance to parents. This resulted~     in 30% improvement in weight gain1,30% reduction in infections, 20% reduction in NICU length~     of stay, 50% reduction in nurse utilization and overall improved satisfaction among parents~     and staff [personal communication, Levin,A.]. Building on the Estonian experience, we have~     developed a new Family Integrated Care (FIC) model that is adapted for the NICU environment~     in North America. In a pilot study at Mount Sinai Hospital, Toronto 46 infants and their~     families were enrolled in the study. Preliminary results and feedback from parents and~     healthcare providers (HCP) show that the FIC model is both feasible and safe, and may lead to~     improved outcomes including improved weight gain(paper submitted for publication). This study~     is a cluster randomized controlled trial in 16 tertiary level NICUs, to evaluate the efficacy~     of the FIC model in Canada.~   "
130999|NCT01852682|"~     The purpose of this study is to investigate efficacy and safety, when administering PA21, in~     peritoneal dialysis patients having hyperphosphatemia.~   "
131000|NCT01852669|"~     This is a randomized controlled trial comparing extracorporeal shockwave lithotripsy (ESWL)~     with and without simultaneous adjunct controlled inversion therapy in the treatment of lower~     pole caliceal stone.~   "
131011|NCT01852526|"~     This study is designed as a randomized, parallel-group, therapy-controlled trial in a~     clinical care setting at a university hospital. Patients presenting to our outpatient clinic~     with degenerative disc disease or spondylolisthesis will be assessed against study inclusion~     and exclusion criteria. After informed consent and randomization of patients, surgery will be~     performed. Follow-up examinations will take place immediately after treatment during hospital~     stay, and then after another 6 and 24 weeks, for a total study duration of 6 months. Data~     will be assessed after 12, 24 and 36 months for a supplemental investigation. A further~     assessment will be performed every year, owing to the possibility that a statement regarding~     ASD cannot be given after 36 months.~      Experimental research in this trial will be performed with the approval of the ethics~     committee of the medical faculty of the University of Cologne and of the university of Halle.~   "
131001|NCT01852656|"~     Influenza disease causes significant morbidity and mortality in the Unites States each year.~     Although influenza can cause morbidity in otherwise healthy individuals, adults with chronic~     lung disease have significantly increased rates of hospitalization from influenza-related~     illnesses compared to healthy adults. Influenza vaccination is the primary means of~     preventing influenza disease. Annual influenza vaccination is recommended for all individuals~     6 months of age and older in the United States. Influenza vaccination rates are sub-optimal,~     however. Patient reminder/recall has been shown, in multiple studies across a variety of age~     groups and health conditions, to increase immunization rates. However, the effectiveness and~     cost-effectiveness of different types of reminder/recall has not been well-studied,~     particularly in adults. In the fall of 2012, the Population and Prevention Services (PPS)~     Department at Kaiser Permanente Colorado (KPCO) is using 3 different reminder strategies for~     influenza vaccination among adults with asthma and chronic obstructive pulmonary disease~     (COPD). The objective of this study is to provide a rigorous evaluation of which strategy is~     more effective and more cost-effective, to promote influenza vaccination.~   "
131002|NCT01852643|"~     Most of the studies performed to compare the present techniques of rhinoplasty have been~     based on the clinical examination and change of postoperative complaints that cannot be very~     precise in evaluating the advantages of one technique over another. Therefore, in this study~     the investigators are going to compare the efficacy of spreader graft and lateral crural~     overlay techniques by an objective method, rhinomanometry.~   "
131003|NCT01852630|"~     1. All consecutive patients with Cirrhosis and ascites admitted to ILBS (Institute of Liver~          & Biliary Sciences) will be evaluated for the presence of SBP (Spontaneous Bacterial~          Peritonitis) by ascitic fluid examination at admission.~        2. SBP (Spontaneous Bacterial Peritonitis) will be diagnosed in the presence of absolute~          neutrophil count (ANC >250/mm3) with/without positive ascitic fluid culture and Patients~          with SBP (Spontaneous Bacterial Peritonitis) included in the study will be randomized to~          receive cefepime or imipenem.~        3. However, other SBP (Spontaneous Bacterial Peritonitis) patients not included for~          randomization will be given empirical therapy with 3rd generation cephalosporin~          (ceftriaxone).~   "
131004|NCT01852617|"~     Argentina and Uruguay are among the countries with the highest proportion of pregnant women~     who smoke. The implementation of an effective smoking cessation intervention would have a~     significant impact on the health of mothers and children. The 5 A's (Ask, Advise, Assess,~     Assist, Arrange) is a strategy consisting of a brief cessation counseling session of 5-15~     minutes delivered by a trained provider, which is considered the standard of care worldwide.~     However, it is under used in Argentina and Uruguay. We will conduct a two-arm, parallel~     cluster randomized controlled trial of an implementation intervention in 20 prenatal clinics~     in Argentina and Uruguay. Our primary hypothesis is that the intervention is feasible in~     prenatal clinics in Argentina and Uruguay and will increase the frequency of women receiving~     tobacco use cessation counseling during pregnancy. Our secondary hypothesis is that the~     intervention will decrease the frequency of women who smoke by the end of their pregnancies.~     Prenatal clinics will be randomly allocated to either an intervention or a control group~     after a baseline data collection period. Midwife facilitators in the ten intervention clinics~     will be identified and trained to deliver the 5 A's to pregnant women and will then~     disseminate and implement the program. The ten clinics in the control group will continue~     with their standard in-service activities. A follow-up data collection will be conducted~     immediately after delivery. The intervention will be tailored by formative research to be~     readily applicable to local prenatal care services at busy maternity hospitals, as well as to~     be acceptable to local pregnant women and health providers. The study will be conducted in 48~     months.~   "
131005|NCT01852604|"~     Parts A and B of this study are designed to evaluate the safety, tolerability, efficacy and~     pharmacokinetic profiles of samatasvir and simeprevir when administered in combination with~     ribavirin (RBV) for 12 weeks in treatment-naïve, Genotype (GT) 1b, 4 and 6 hepatitic C virus~     (HCV)-infected participants.~      Part C of this study is designed to evaluate the safety, tolerability, efficacy and~     pharmacokinetic profiles of samatasvir, simeprevir, TMC647055 and ritonavir (RTV) when~     administered in combination with or without RBV for 12 weeks in treatment-naïve or~     interferon/RBV-treatment relapsed, GT 1a and 1b HCV-infected participants.~   "
131006|NCT01852591|"~     There is no study hypothesis. The purpose of this study is to see if the Pneumococcal~     conjugate vaccine (PCV13), when administered before and early after an autologous peripheral~     stem cell transplant will induce an immune response.~   "
131007|NCT01852578|"~     The investigators propose to study the single agent activity of Cabazitaxel in a Phase II~     trial of subjects with relapsed or refractory non-small cell lung cancer pretreated with~     docetaxel, given the fact of its significant activity and its acceptable toxicity profile.~   "
131008|NCT01852565|"~     Darapladib (SB-480848) is a novel, selective, orally active inhibitor of lipoprotein~     associated phospholipase A2 (Lp-PLA2) currently under clinical development by GlaxoSmithKline~     as a potential anti-atherosclerosis agent for reduction of major adverse cardiovascular (CV)~     events in patient populations with chronic coronary heart disease and after an acute coronary~     syndrome.~      This study will determine the effect of repeated administration of diltiazem on the~     pharmacokinetics of a repeated administration of darapladib. A drug interaction study with a~     moderate CYP3A4 inhibitor is warranted to provide guidance to prescribing physicians.~   "
131009|NCT01852552|"~     Multicenter, prospective, observational study in aortic stenosis (AS) patients undergoing~     transcatheter aortic valve implantation (TAVI) or high-risk patients undergoing aortic valve~     replacement (AVR).~      The objectives of the study are:~        1. Description of neurocognitive status before and after transcatheter aortic valve~          implantation and aortic valve replacement procedures~        2. Description of Quality of Life (QoL) after these procedures~        3. Defining the relevance of baseline psychological, emotional and cognitive factors on the~          outcomes associated to the different treatment modalities~        4. Assessment of costs associated to each of the above mentioned strategies of treatment,~          including costs of the index hospitalization and costs of follow-up.~   "
131010|NCT01852539|"~     The investigators attempted to determine the optimal dose of dexmedetomidine required for the~     successful insertion of LMA during propofol induction without a neuromuscular blocking agent.~   "
131017|NCT01852448|"~     Cystic fibrosis related diabetes (CFRD) is associated with worse CF-relevant outcomes.~      The mechanisms underlying CFRD development are not fully understood, but recent evidence~     suggests Type 2 Diabetes Mellitus (T2DM) mechanisms may be involved and may involve incretins~     (gut secreted hormones that augment insulin secretion in response to a nutrient load).~      This study will examine the prevalence of Genome wide association study (GWAS)-implicated~     T2DM alleles (including TCF7L2) across the spectrum of glucose abnormalities in CF and will~     use this information to compare incretin and insulin secretion in non-diabetic children and~     adults with high risk and low risk alleles.~   "
131018|NCT01852435|"~     The main purpose of this study is to evaluate the safety and efficacy of R-CEOP-90/R-CEOP-70~     Versus R-CHOP-50 in the Treatment of Diffuse Large B-cell lymphoma and Follicular Lymphoma~     Grade 3B patients.~   "
131019|NCT01852422|"~     Pelvic organ prolapse is a common disorder that results in significant patient morbidity.~     Approximately 1 in 9 women undergo surgery for the correction of pelvic organ prolapse (POP)~     and associated bladder and bowel dysfunction. Despite its common occurrence, the cause of POP~     remains largely unknown. Prolapse is thought to be caused by direct injury to the levator ani~     (LA) muscle, denervation of the pelvic floor musculature, or fascial damage incurred during~     childbirth trauma. The sacrospinous ligaments are commonly employed surgical structures~     employed to repair vaginal prolapse. Despite the frequent use of these structures in prolapse~     surgery, there is a paucity of information regarding the identification of these structures~     outside of surgical dissection. Furthermore, there is no published data describing the~     relative distances between the apex of the vagina and these ligaments in women with prolapse.~     Recent developments in imaging have enabled the identification of the distal subdivisions of~     the levator ani, classifying as: pubovaginalis, puboanalis, and the puboperinealis as the~     subdivisions of the pubovisceralis. The visualization of these structures is possible using a~     3D ultrasound technique (BK medical, Wilmington, MA), that has been validated in cadavers and~     in live humans, with excellent interrater reliability. The investigators propose to use this~     technology to explore the anatomy of the sacrospinous ligaments.~   "
131020|NCT01852409|"~     Malignant ascites often has a profound impact on the quality of life of cancer patients.~     Current treatments,including dietary, medical, and procedural are often temporary and~     unsatisfactory options in patients approaching the end of life. Intraperitoneal bevacizumab~     for the palliation of malignant ascites might be a novel choice for refractory malignant~     ascites.~   "
131021|NCT01852396|"~     The goal of this study is to demonstrate that the novel retroclavicular approach is a safe,~     fast and effective technique for ultrasound-guided brachial plexus anesthesia.~   "
131022|NCT01852383|"~     Dysthymic disorder (DD) denotes chronic depression with fewer symptoms than major depressive~     disorder (MDD), and it affects ~ 2-4 % of adults with a similar prevalence in the elderly. In~     the elderly, dysthymic disorder (DD) has been shown to be associated with suffering and~     disability. The differences between young adult and elderly DD patients indicate that~     findings obtained in young adults with DD cannot be extrapolated to elderly DD patients who~     need to be studied separately. Data from epidemiologic studies support this view. In contrast~     to the data in young adult DD patients, there is a paucity of controlled data on the~     treatment of elderly DD patients. In our center, a double-masked, placebo-controlled study of~     91 elderly DD patients did not find significant superiority for fluoxetine over placebo with~     response rates of 27.3% for fluoxetine and 19.6% for placebo in intent-to-treat analyses, and~     response rates of 37.5% for fluoxetine and 23.1% for placebo in completer analyses. Given the~     relative failure of selective serotonin reuptake inhibitor (SSRIs) to treat geriatric DD~     effectively, the investigators decided to evaluate the dual reuptake inhibitor, venlafaxine.~      The investigators earlier completed an investigator-initiated, open-label 12-week venlafaxine~     (Effexor XR) trial. Of 23 elderly DD patients, 18 completed the trial. Fourteen (60.9%) were~     responders in intent-to-treat analyses with the last observation carried forward, and 77.8%~     were responders in completer analyses. Nearly half the sample (47.8%) met criteria for~     remission. In the intent-to-treat sample, increased severity of depression at baseline was~     associated with superior response and the presence of cardiovascular disease was associated~     with poorer response. These results with venlafaxine indicate that further treatment studies~     of dual serotonin-norepinephrine reuptake inhibitors like duloxetine are warranted in elderly~     patients with dysthymic disorder.~   "
131023|NCT01852370|"~     The purpose of this study is to determine whether bilateral orthotopic lung transplantation~     (BOLT) followed by cadaveric partially-matched hematopoietic stem cell transplantation (HSCT)~     is safe and effective for patients aged 5-45 years with primary immunodeficiency (PID) and~     end-stage lung disease.~   "
131024|NCT01852357|"~     The primary objective of this study is to evaluate the effectiveness of neurofeedback~     training (NFB) on objective measurements of attention in young adults with ADHD. The~     secondary objectives are to evaluate neurofeedback effects on self-report measures of~     attention, ADHD symptoms, and to identify electroencephalogram (EEG) markers of ADHD and~     neurofeedback efficacy. The study is a double-blind, placebo controlled clinical trial to~     test the efficacy and safety of EEG neurofeedback in individuals 18-40 years of age with~     attention deficit hyperactivity disorder (ADHD). Attention will be evaluated at baseline,~     after 12 and 24 training sessions (an average of 4 and 8 weeks, respectively), and 4 weeks~     after the last neurofeedback session. The primary outcome will be change from baseline on the~     Attention Performance Index (API) variable of the Test of Variables of Attention (TOVA) a~     standardized, well-normed, computerized test of attention, after 12 neurofeedback or sham~     training sessions (and average of 4 weeks). Secondary outcomes will be change from baseline~     on other TOVA variables after 12 and 24 sessions (an average of 4 and 8 weeks, respectively),~     at 4 weeks post-training follow-up, and changes from baseline at each time point on the Adult~     Self Report Scale (ASRS) and Mindful Awareness and Attention Scale (MAAS). EEG data collected~     during TOVA attention testing at baseline will be used to model EEG differences between ADHD~     and non-ADHD participants. Additional EEG data collected during the TOVA at midpoint (average~     of 4 weeks), after 24 NFB sessions (average of 8 weeks), and 4 weeks post-NFB will be used to~     develop statistical models to use as indicators of neurofeedback efficacy~   "
131025|NCT01852344|"~     Effortful control refers to the mental processes that help a person to regulate his or her~     own attention, thoughts, and emotions. This study will examine behavioral differences in~     healthy individuals when performing a task that induces fatigue.~      The purpose of this study is to examine the effects of methylphenidate on the cognitive~     functions in healthy individuals when performing fatiguing cognitive tasks.~   "
131026|NCT01852331|"~     The investigators hypothesize that Peony-Glycyrrhiza Decoction (PGD) adjunctive therapy could~     reduce the incidence of prolactin (PRL)-related adverse events in patients with schizophrenia~     and suppress antipsychotic-induced elevation of PRL levels.~      This is a placebo-controlled trial conducted in schizophrenic patients to determine whether~     PGD adjunctive treatment could produce greater biochemical and clinical improvement on~     hyperprolactinemia (hyperPRL) compared to placebo treatment.~   "
131027|NCT01852318|"~     Pruritus s a very distressing problem affecting patients with uremia and the prevalence of~     uremic pruritus (UP) ranges between 22% to 66%. Although some studies suggested pruritus is~     being decreased recently by use of better dialysis techniques, accumulating studies have~     shown the still high prevalence of UP. Because of its long duration, frequency and high~     intensity, UP has been reported to have a negative impact upon the patients' quality of life~     (QoL). However, the therapies in use, including antihistamines, ultraviolets, opioid~     antagonists and topical agents, are generally of insufficient efficacy, failing to provide~     adequate and long-lasting relief. Based on the neuropathic hypothesis and frequent~     co-occurrence of chronic pruritus and peripheral neuropathy in the patients undergoing~     hemodialysis, gabapentin, a medication widely used for a spectrum of neuropathic pain~     syndromes, has recently been suggested to be effective in the treatment of UP.Pregabalin,~     another gabaergic drug structurally related to gabapentin, have an advantage over gabapentin~     in terms of its more rapid response to stressful symptoms. Only two very recently~     small-scaled studies evaluate the effect of pregabalin for UP. However, both these studies~     were not randomized, placebo-controlled trails.As UP is still one of the most vexing and~     disabling symptoms in patients with ESRD, we decided to do this multicenter, randomized~     double-blind placebo-controlled trial (RCT) with a larger sample size and a longer duration.~   "
131028|NCT01852305|"~     Purpose:~      The purpose of this study is to develop a novel pathway to decrease the cost and waiting time~     to manage bariatric surgical patients with obstructive sleep apnea.~      Hypotheses:~      Compared to the current perioperative pathway, the proposed novel pathway incorporating~     overnight oximetry and perioperative sleep apnea precautions is safe and more cost effective~     for evaluating and managing obstructive sleep apnea in the bariatric surgical patients.~      To decrease the cost and waiting time, we proposed a novel perioperative pathway to manage~     obstructive sleep apnea in the bariatric patients. In this pathway, the patient will be~     screened by the STOP-Bang questionnaire. The recruited patients will be randomized into two~     groups:~      The STOP-Bang questionnaire score is ≥4 then you will be assigned to any one of these groups~        -  sleep study group (group 1) or~        -  oximetry group (group 2).~   "
131029|NCT01852292|"~     Phase II Study of efficacy and safety of buparlisib (BKM120) plus paclitaxel versus placebo~     plus paclitaxel in recurrent or metastatic Head and Neck cancer previously pre-treated with a~     platinum therapy.~   "
131030|NCT01852279|"~     This study will assess whether functional recovery of the hand muscles in patients with~     spinal cord injury is enhanced when electrical stimulation of the muscles is delivered~     actively by means of using the electroencephalography wave patterns arising from the patient~     imagining moving their hand to operate the stimulator. A control group will obtain the~     electrical stimulation treatment passively by a therapist operating the machine.~   "
131031|NCT01852266|"~     Human respiratory syncytial virus (RSV) is a common cause of respiratory illness in infants~     and children. This study will evaluate the safety and immune response to an RSV vaccine in~     healthy RSV-naïve children.~   "
131032|NCT01852253|"~     Peri-implantitis is a infectious disease that resides in the mucosa surrounding dental~     implants and also affects the supporting bone. Because the number of implants placed in~     everyday clinical practice is continuously increasing, is it reasonable to anticipate an~     increasing prevalence of peri-implantitis. This underlines the necessity for a predictable~     therapy. However, from the literature there is very little reliable evidence suggesting which~     could be the most effective interventions for treating periimplantitis.~      The primary objective of this controlled clinical study is to evaluate the clinical effect of~     decontamination of the implant surface during the surgical treatment of peri-implantitis~     using a 2% chlorhexidine solution or a 0.12% chlorhexidine solution. The secondary objective~     is to assess the microbiological effect of decontamination of the implant surface during the~     surgical treatment of peri-implantitis using a 2% chlorhexidine solution or a 0.12%~     chlorhexidine solution.~      The primary study parameter is the change from baseline in modified bleeding index. Secondary~     study parameters are: change in microbial composition of the biofilm covering the dental~     implant surface; microbiological composition of the peri-implant sulcus; change in probing~     pocket depth;change in suppuration on probing; change in radiographic marginal bone level on~     standardized intraoral radiographs; change in modified plaque index; implant failure, defined~     as implant mobility of previously clinically osseointegrated implants and removal of~     non-mobile implants because of progressive marginal bone loss or infection; complications and~     adverse events. It is hypothesized that decontamination of the implant surface with 2%~     chlorhexidine leads to a greater decrease in modified bleeding index than decontamination~     with a 0.12% chlorhexidine solution.~   "
131033|NCT01852240|"~     Background Increased levels of C reactive protein (CRP) can be found not only within~     individuals with periodontal diseases and those with atherosclerotic alterations but also~     have been proved in men with erectile dysfunction (ED). NO seems to be the key mediator in~     the endothelial-derived vasodilation and penile erection.~      The incidence of ED increases in patients with diabetes, hypertonia, hypercholesteremia,~     cardiovascular diseases and renal failure. First evidence suggests that there is a~     relationship between periodontal disease and ED as well. Due to slow progression of chronic~     periodontal disease (0.3-0.5mm attachment loss/year) it can be assumed, that periodontal~     disease exists mainly before ED develops.~      Specific Aims This cross-sectional study aims to assess the incidence of periodontal disease~     in male individuals with ED. A possible correlation between severity of periodontal disease,~     level of systemic hs-CRP and ED will be assessed. Additionally, further risk factors for~     endothelial dysfunction, such lipid values, will be determined and regarded in the analysis.~      Hypothesis The investigators assume, that severity of ED correlates with severity of~     periodontal disease as well as with systemic involvement assessed by CRP-levels. In detail,~     the investigators hypothesize, that severity of ED (assessed by the questionnaire~     International Index of Erectile Function) correlates with the mean probing depth and the~     level of systemic hs-CRP.~      Material and Methods~        1. st appointment: In the present cross-sectional study 100 male patients with ED will be~          included. Patients who visit the urological department (Rudolfstiftung) for ED-treatment~          will be asked to participate. The erectile dysfunction will be assessed by means of a~          questionnaire (International Index of Erectile Function - IIEF-5). Urologic examination.~          The following blood parameters will be assessed: testosterone, prolactin, hs-CRP, tumor~          necrosis factor (TNF)-alpha, Interleukin-1, total cholesterol, LDL, HDL, HbA1c and~          fasting glucose.~        2. nd appointment: At the department of Oral Surgery (Bernhard Gottlieb School of~          Dentistry) the periodontal situation and the index of decayed-missing-filled permanent~          teeth (DMFT) index of the patients will be determined. A panoramic radiograph for~          assessment of alveolar bone loss and a periodontal status (probing depth, recession,~          bleeding- and plaque-indices) will be performed. The observer at the dental clinic will~          have no information on the severity of the ED (observer blinded).~   "
131034|NCT01852227|"~     In collaboration with the Neurointerventional programs at state university of new york~     Buffalo, state university of new york Stonybrook, Swedish Medical Center, Erlanger Health~     System, Vanderbilt University, and West Virginia University School of Medicine, the~     investigators aim to prospectively collect experiences where direct aspiration as a first~     pass technique is used for thrombectomy procedures.~      The investigators also want to compare specific characteristics from these cases to other~     stroke cases where traditional thrombectomy devices were used.~   "
131035|NCT01852214|"~     Patients with diabetes mellitus (DM) have an increased risk of adverse atherothrombotic~     events. This may be in part attributed to the fact that these patients have reduced response~     to oral antiplatelet medications, in particular the P2Y12 receptor inhibitor clopidogrel,~     used for secondary prevention of ischemic events. Prasugrel and ticagrelor are recently~     approved P2Y12 receptor inhibitors which, compared with clopidogrel, have more potent~     antiplatelet effects. Head-to-head comparisons between the two drugs are lacking.~   "
131036|NCT01852201|"~     Primary Endpoint:~      The primary objective is to show that AIS patients, ineligible for or refractory to treatment~     with IV-tPA, with appropriate image selection, treated with mechanical thrombectomy within~     6-12 hours of symptom onset have less stroke related disability and improved good functional~     outcomes as compared to those treated with best MT with respect to endpoint defined as:~      • 90-day global disability assessed via the modified Rankin score (mRS), analyzed using raw~     mRS scores. Statistical details can be found in section 7.2.~      Secondary Endpoints:~        -  90-day global disability in the 6-12 hr cohort assessed via the overall distribution of~          mRS~        -  Proportion of patients with good functional recovery for the 6-12 hr cohort as defined~          by mRS 0-2 at 90 days~        -  Mortality at 30 and 90 days~        -  Intracranial hemorrhage with neurological deterioration (NIHSS worsening >4) within 24~          hours of randomization~        -  Procedure related serious adverse events (SAE's)~        -  Arterial revascularization measured by TICI 2b or 3 following device use~   "
131037|NCT01852188|"~     The purpose of this study is to determine whether the use of sterile or clean gloves during~     labor exams affects the rate of chorioamnionitis. Chorioamnionitis is an infection of the~     membranes around the baby.~   "
131038|NCT01852175|"~     Recently, two P2Y12 receptor inhibitors have been approved for clinical use: prasugrel and~     ticagrelor. Both prasugrel and ticagrelor have shown to be associated with more potent~     antiplatelet effects compared with clopidogrel and are associated with an improved net~     clinical benefit. However, to date there are limited head-to-head comparisons of these two~     new agents.~   "
131039|NCT01852162|"~     Dual antiplatelet therapy consisting of aspirin and clopidogrel is the cornerstone of~     treatment for prevention of atherothrombotic events in patients with coronary artery disease~     (CAD) undergoing percutaneous coronary interventions (PCI). Many patients on dual~     antiplatelet therapy in this setting may be affected by other thromboembolic conditions, in~     particular atrial fibrillation, therefore having an indication to also receive oral~     anticoagulation for stroke prevention. Thus, a considerable percentage of patients are under~     triple therapy which consists of aspirin plus clopidogrel plus an oral anticoagulant. The~     ever raising population with CAD warranting triple therapy and the growing number of patients~     being treated with dabigatran underscores the importance of understanding the pharmacodynamic~     effects of this treatment regimen.~   "
131040|NCT01852149|"~     The purpose of this study is to assess the safety and feasibility of the Mitralign~     Percutaneous Annuloplasty System in humans for the treatment of chronic functional mitral~     regurgitation. No formal test of hypothesis is proposed for this trial.~   "
131041|NCT01852136|"~     This prospective, multi-center, 2 period cross-over study is designed to determine if people~     who use injection pens for subcutaneous medication delivery prefer the BD NEXT pen needle~     (PN) in comparison with currently marketed pen needles of the same or similar gauge and~     length. Subjects will use the investigational (BD NEXT) PN and their usual conventional PN~     each for one week in a randomly assigned sequence, and will be asked to evaluate and compare~     characteristics of the BD NEXT pen needle versus their usual pen needle when used for all~     their pen injections performed at home. Since injection experience may vary according to the~     type of pen device used, equal numbers of subjects will be recruited who are users of three~     of the most commonly used insulin pen injectors.~   "
131042|NCT01852123|"~     In patients with chest pain the diagnosis of a heart attack (myocardial infarction) is made~     where there is evidence of heart muscle damage using a blood test to measure the heart muscle~     protein troponin. A new a more sensitive troponin test may help us to identify patients with~     myocardial infarction more easily.~      The investigators propose to evaluate whether use of a novel high-sensitivity troponin test~     to lower the threshold for diagnosis of myocardial infarction is appropriate. If increased~     sensitivity does not reduce specificity for the diagnosis, then this new test will improve~     patient outcome through better targeting of therapies for coronary heart disease. However, if~     increased sensitivity leads to poor specificity, then patients may be misdiagnosed and given~     inappropriate cardiac medications with potentially detrimental outcomes.~      In ten secondary and tertiary care hospitals across Scotland, the investigators will~     undertake a stepped wedge cluster randomized controlled trial of the implementation of a~     novel high-sensitivity troponin test. The primary end-point will be the one-year rate of~     cardiovascular death or recurrent myocardial infarction. This will establish whether the~     introduction of this high-sensitivity troponin test into routine clinical practice is~     beneficial to patient management and outcomes.~      A subset of patients will be asked to give consent for inclusion into a sub-study that will~     permit storage of blood samples and will require the completion of a survey during the index~     admission and after 6 and 12 months of follow up.~   "
131043|NCT01852110|"~     The purpose of this multicenter trial is to assess the efficacy and safety of MK-7622~     compared with placebo as adjunctive therapy to acetylcholinesterase inhibitors (AChEIs) for~     the symptomatic treatment of participants with mild to moderate Alzheimer's Disease (AD). The~     trial consists of two stages: Stage 1 and Stage 2. In Stage 1, participants will be~     randomized to receive either placebo or MK-7622 45 mg once daily. In Stage 2, participants~     will be randomized to receive either placebo or MK-7622 (dose: 5, 15 or 45 mg once daily).~     Participants will be enrolled in only one stage; the duration of each stage is approximately~     26 weeks. Interim analyses will be performed in both Stage 1 and Stage 2 to determine whether~     the trial should continue. The primary study hypotheses are the following: Stage 1 - MK-7622~     45 mg once daily is superior to placebo with respect to improving cognition in participants~     with mild to moderate AD as assessed by mean change from baseline in the 11-item Alzheimer's~     Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) at Week 12; Stage 2 - At least one~     of the top two doses of MK-7622 (15 mg once daily, 45 mg once daily) is superior to placebo~     with respect to improving cognition in participants with mild to moderate AD as assessed by~     mean change from baseline in ADAS-Cog11 at Week 12.~   "
131064|NCT01851824|"~     This open-label, multicenter, 3-period, fixed-sequence study will evaluate the effect of~     multiple doses of vemurafenib on the pharmacokinetics of a single dose of acenocoumarol in~     participants with BRAFV600 mutation-positive metastatic malignancies. Participants will~     receive a single dose of acenocoumarol 4 mg orally on Day 1 and Day 23, vemurafenib 960 mg~     orally twice daily on Days 4-26. After completion of pharmacokinetic assessments on Day 26,~     eligible participants will have the option to continue treatment with vemurafenib as part of~     an extension study (GO28399 [NCT01739764]).~   "
131044|NCT01852097|"~     Background Inflammatory Bowel Disease (IBD) is a group of lifelong and relapsing inflammatory~     conditions that usually affect the colon and the small intestine. Between 30 to 45% of~     patients with IBD do not take their treatment as prescribed by their health care team~     (Jackson, Clatworthy et al. 2010). The Perceptions and Practicalities Approach (PAPA)~     provides a theoretical framework to develop adherence interventions that are patient-centred~     (Horne, 2001). Unintentional non-adherence occurs when the patient wants to take the~     medication but there are barriers beyond their control, such as not understanding the~     instructions (practical barriers). Intentional non-adherence is the result of the beliefs~     affecting the patient's motivation to continue with treatment (perceptual barriers).~      Aims~        1. To develop an internet-based intervention to address perceptual and practical barriers~          to adherence to medicine for IBD.~        2. To determine whether the intervention is effective based on change in both types of~          barriers.~      Plan of Investigation The inclusion criteria are: age 18 or over; diagnosis of IBD; currently~     prescribed azathioprine, mesalazine, and/or adalimumab.~      240 participants identified via Crohn's and Colitis UK and through two NHS IBD clinics will~     take part in the study. An online pilot Randomised Controlled Trial will allocate the~     participants either to a Cognitive Behavioural Therapy (CBT) based online intervention or~     Treatment as Usual group. On first visiting the website, participants will be screened for~     eligibility and asked for consent before answering the questionnaires. The website will~     assign intervention modules to be completed based on an individual's profile.~      Outcomes: Beliefs about Medicines scores will be measured at baseline, 1 month and 3 month~     follow-ups.~      Potential Impact A CBT based online intervention tailored to personal needs and concerns may~     benefit a large number of patients with low costs for the national healthcare services. A~     website can be accessed at a time and place convenient to the patient.~   "
131045|NCT01852071|"~     In this current study, the investigators will determine whether using a lentiviral vector~     (based on HIV-1) will be more effective and safer at gene transfer to hematopoietic stem~     cells compared to previous gene transfer vectors based on murine (mouse) retroviruses for~     ADA-deficient SCID. The level of gene transfer in blood cells and immune function will be~     measured as endpoints.~   "
131046|NCT01852058|"~     This study will evaluate the long-term safety and efficacy of onabotulinumtoxinA for the~     treatment of urinary incontinence due to neurogenic detrusor overactivity in patients who~     successfully completed Study 191622-120.~   "
131047|NCT01852045|"~     This study will evaluate the safety and efficacy of onabotulinumtoxinA for the treatment of~     urinary incontinence due to neurogenic detrusor overactivity in pediatric patients between~     the ages of 5 to 17 years.~   "
131048|NCT01852032|"~     The purpose of this study is to compare the imaging performance of an investigational breast~     computed tomography (CT) scanner, built at UC Davis, with that of an FDA-Approved breast~     tomosynthesis scanner (capable of producing standard 2-D mammography and 3-D tomosynthesis~     images), built by Hologic, Incorporated, in a group of patients with suspected breast cancer.~   "
131049|NCT01852019|"~     To demonstrate that patients treated with cangrelor can be directly switched to oral~     prasugrel and that patients treated with prasugrel can be switched to cangrelor without a~     significant decrease in the extent of inhibition of platelet aggregation.~   "
131050|NCT01852006|"~     Conventional approaches to relieve dyspnea (respiratory discomfort) in chronic obstructive~     pulmonary disease (COPD) have focused on improving respiratory motor drive (e.g., hyperoxia)~     and/or dynamic respiratory mechanics (e.g., bronchodilators). Although these approaches yield~     meaningful symptom improvements there remains many COPD patients incapacitated by dyspnea.~     Accumulating evidence suggests that abdominal binding (AB) is a potentially novel method of~     improving respiratory muscle function and, by extension, dyspnea and exercise tolerance in~     COPD. Thus, the purpose of this randomized, cross-over study is to test the hypothesis that~     AB improves exertional dyspnea and exercise tolerance in symptomatic patients with COPD by~     improving dynamic respiratory muscle function. To this end, the investigators will examine~     the effects of AB on detailed assessments of baseline pulmonary function (spirometry,~     plethysmography), dyspnea (sensory intensity & affective responses), neural respiratory drive~     (diaphragm EMG), contractile respiratory muscle function (esophageal, gastric &~     transdiaphragmatic pressures), ventilation, breathing pattern and cardiometabolic function~     during symptom-limited constant load cycle exercise (75% Wmax) in 20 patients with GOLD stage~     II/III COPD.~   "
131051|NCT01851993|"~     Dyspnea refers to the awareness of breathing discomfort that is typically experienced~     during exercise in health and disease. In various participant populations, dyspnea is a~     predictor of disability and death; and contributes to exercise intolerance and an adverse~     health-related quality-of-life. It follows that alleviating dyspnea and improving exercise~     tolerance are among the principal goals of disease management. Nevertheless, the effective~     management of dyspnea and activity-limitation remains an elusive goal for many healthcare~     providers and current strategies aimed at reversing the underlying chronic disease are only~     partially successful in this regard. Thus, research aimed at identifying dyspnea-specific~     medications to complement existing therapies for the management of exertional symptoms is~     timely and clinically relevant. The purpose of this study is to test the hypothesis that~     single-dose inhalation of nebulized ondansetron (a serotonin 5-HT3 receptor antagonist) will~     improve the perception of dyspnea during strenuous exercise in health, young men. To this~     end, the investigators will compare the effects of inhaled 0.9% saline placebo and inhaled~     ondansetron (8 mg) on detailed assessments of neural respiratory drive (diaphragm EMG),~     ventilation, breathing pattern, dynamic operating lung volumes, contractile respiratory~     muscle function, cardio-metabolic function and dyspnea (sensory intensity and affective~     responses) during symptom-limited, high-intensity, constant-work-rate cycle exercise testing~     in healthy, men aged 20-40 years.~   "
131065|NCT01851811|"~     Despite widespread agreement that continuous positive airway pressure is effective therapy~     for obstructive sleep apnea, it is estimated that 50% of patients recommended for therapy are~     noncompliant 1 year later. Nasal continuous positive airway pressure (CPAP) is the most~     definitive medical therapy for obstructive sleep apnea (OSA). Many patients have difficulty~     tolerating nasal CPAP due to nasal airway problems, mouth leak, and general discomfort from~     the mask and headgear. Interventions to improve compliance in such patients have not been~     studied. The investigators plan to further evaluate the usage of CPAP and identify if the~     timing of last meal before bedtime affects the compliance and tolerance of CPAP.~   "
131164|NCT01850511|"~     Nasal obstruction is a common complaint prompting presentation to an otolaryngologist. Many~     studies have been performed quantifying and describing the impact of a number of factors on~     symptoms of nasal obstruction, including anatomical, neoplastic, infectious, and inflammatory~     causes. Despite this scrutiny, no attention has been paid to the nasal vibrissae as a~     potential anatomical contributor to nasal obstruction. The proposed study intends to~     elucidate that contribution, if any exists.~   "
131165|NCT01850498|"~     Evaluate patient motion during seizures.~   "
131052|NCT01851980|"~     Breathlessness on exertion is a common and troublesome complaint of individuals with~     restrictive lung disorders. In these adults, breathlessness contributes to physical~     activity-limitation and avoidance and an adverse health-related quality-of-life, often in a~     self-perpetuating cycle. It follows that alleviating dyspnea and improving exercise tolerance~     are among the principal goals in the management of adults with restrictive lung disorders.~     Nevertheless, effective management of breathlessness and physical activity-limitation remains~     an elusive goal for many healthcare providers and current therapies (e.g., antifibrotic~     agents, oxygen, exercise training) are only partially successful in this regard. Thus,~     research aimed at identifying breathlessness-specific medications to complement existing~     therapies for the management of physical activity-related breathlessness in restrictive lung~     disorders is timely and both clinically and physiologically relevant. The purpose of this~     randomized crossover study study is to examine the acute effects of two doses of inhaled~     nebulized furosemide (a loop diuretic) on the perception of breathlessness during~     laboratory-based cycle exercise in healthy, young men in the presence of an external thoracic~     restriction to mimic a 'mild' restrictive lung deficit. To this end, the investigators will~     compare the effects of inhaled 0.9% saline placebo and inhaled furosemide (40 mg and 120 mg)~     on detailed assessments of breathlessness (sensory intensity and affective responses) and its~     physiological determinants (ventilation, breathing pattern, dynamic operating lung volumes,~     cardio-metabolic function) symptom-limited, high-intensity, constant-work-rate cycle exercise~     testing with external thoracic restriction sufficient to mimic a 'mild' restrictive pulmonary~     deficit in healthy, men aged 18-40 years.~   "
131053|NCT01851967|"~     This study aims to evaluate efficacy and acceptability of the Chinese language version of~     MoodGYM as a therapeutic intervention in treating symptoms of depression in community~     dwelling Chinese Americans in the Boston area.~      Hypothesis 1: Participants enrolled in MoodGYM will show a significant decrease in depressive~     symptoms after completion of the 5 modules.~      Hypothesis 2: Participants enrolled in MoodGYM will show significantly improved dysfunctional~     thinking.~      Hypothesis 3: Participants enrolled in MoodGym will rate this program as culturally~     acceptable.~   "
131054|NCT01851954|"~     The purpose of this study is to investigate the pharmacokinetics of clarithromycin which is~     used for premature infants with ureaplasma.~   "
131055|NCT01851941|"~     The role of perioperative chemotherapy in potentially operable advanced gastric cancer (AGC)~     with regional lymph node metastasis is still in the area of controversy. The aim of this~     study is to evaluate the efficacy and toxicity of folinic acid (FA), infusional~     5-fluorouracil (5-FU), and oxaliplatin (modified FOLFOX6) in potentially resectable AGC with~     regional lymph node (LN) metastasis.~   "
131056|NCT01851928|"~     The objective of this study is to evaluate the sensitivity and specificity of two nutrition~     screening tools to identify inpatients with malnutrition or at risk of malnutrition. The two~     tools are the Royal Marsden Abridged Adult Nutrition Screening Tool (AANST) and the~     Malnutrition Screening Tool (MST)[10] The tools will be compared with the currently accepted~     gold standard, Patient Generated Subjective Global Assessment (PG-SGA). Both screening tools~     are in the form of scored questionnaires and are suitable for electronic input.~      The ultimate objective is to select an adult inpatient nutrition screening tool with the~     highest sensitivity for future use in the oncology inpatient setting in order to allow prompt~     commencement of an appropriate nutrition care plan.~   "
131057|NCT01851915|"~     In this study, the differential effectiveness of CBT and IPT for patients with Major~     Depressive Disorder, who rate their depression as mild or moderate, will be studied. Both~     methods are evidence based and recommended by the National Board of Health in Sweden. They~     are manual based and the patients will receive 14 sessions in each therapy. Their comparative~     effectiveness has not been studied in Sweden, and their effectiveness with regard to work~     capacity has not been tested. The hypotheses in the study are that they have equal effect for~     depression remission, but that CBT is superior when return to work is measured. Three~     moderator analyses, testing effects for different subgroups, will be made. They propose that~     patients with attachment avoidance and lower mentalization ability and male patients will~     have better outcome with CBT. The study will be performed at Sundsvall Hospital, in~     cooperation with Linköping University. Sundsvall hospital is the only hospital in Sweden~     where there is a group IPT therapists large enough to make a controlled study possible. The~     study has a randomized design, with 16 therapists, 8 of them delivering CBT and 8 IPT. The~     number of patients is 96. The statistical power is .87, with a hypothesized between-groups~     effect size of d = .40 for return to work, and the significance level of .05 for the~     between-groups difference. Outcome will be measured as remission of psychiatric diagnosis,~     decrease in depression severity and frequency of patients who return to work. Both~     intent-to-treat and completers analyses will be made. The project will go over two years. The~     study has an effectiveness character in the sense that treatments, although manual based,~     will be performed in the manner that the therapists usually work, and by having broad~     inclusion criteria. Treatment integrity will be ascertained by therapist reports and by~     filming sessions.~   "
131058|NCT01851902|"~     The purpose of this study is to determine, through continuous monitoring with a cardiac~     monitoring device placed under the skin, the incidence of atrial fibrillation or flutter~     (AF). The cardiac monitor will be placed in patients without symptoms but at risk for AF. It~     is hoped that this information may assist health care professionals in treatment decisions~     related to the early identification of patients at high risk for AF.~   "
131059|NCT01851889|"~     The purpose of the trial is to identify factors which can be used as guidance when optimizing~     continuous-flow left ventricular assist device (CF-LVAD) settings.~      The hypothesis of the study is that pulmonary capillary wedge pressure (PCWP) will change~     independently of left ventricular end diastolic diameter (LVEDD) when increasing pump speed~     ie ΔPCWP/RPM ≠ ΔLVEDD/RPM.~      The primary combined endpoint of the study is correlation between ΔPCWP and LVEDD slope under~     ramp testing in a cohort of continuous-flow left ventricular assist device heart failure~     patients.~   "
131060|NCT01851876|"~     Endometrial injury increases clinical pregnancy rate in normoresponder patients undergoing~     long agonist protocol intracytoplasmic sperm injection cycles with single embryo transfer.~   "
131061|NCT01851863|"~     The study hypothesis is appropriate clinician-patient communication that provides~     explanations of the reasons for psychoactive drug prescriptions based on the generation of FD~     symptoms and the drugs' effects might improve compliance with psychoactive agent regimens~     among FD patients.~   "
131062|NCT01851850|"~     The purpose of the study is to extend the use of opicapone 25 or 50mg once per day by~     subjects who participated in the BIA 9-1067-302 clinical trial according form 4a for~     additional three years.~   "
131063|NCT01851837|"~     The exercise time is an important factor among the medical guides for weight loss; however,~     there is still little knowledge about exercise duration paths in middle-aged and older women.~     The present study aimed to determine the effects of the interval training on weight loss and~     lipid profile, and to compare its efficiency with the continuous training.~   "
131066|NCT01851798|"~     Obstructive sleep apnea (OSA) is a relatively common medical condition that includes~     upper-airway obstruction and consequent cessation of breathing during sleep with significant~     associated other medical problems. The time period around surgery has been demonstrated to be~     an independent risk factor for various complications but the mechanism is not well~     understood.~      This protocol proposes to study the fundamental question of what changes occur in the~     postoperative setting to ambulatory patients with and without OSA by administering a~     validated STOP-BANG screening questionnaire and conducting preoperative and postoperative~     Home Sleep Testing (HST). In doing so, critical evidence shall be gained in the understanding~     of postoperative sleep disorder breathing changes associated with surgery and anesthesia.~     With evidence, sound perioperative management recommendations and policy may be developed to~     assist with caring for this large and at risk surgical population.~   "
131067|NCT01851785|"~     A randomized, controlled design will be utilized to examine and compare the effectiveness of~     the proposed educational intervention, which includes an educational decision aid with~     attention control on select key patient-centered and process of care outcomes. The study~     sample will consist of approximately 300 African-American patients with osteoarthritis (OA)~     of the knee. Patients will be recruited from Pennsylvania Presbyterian Medical Center and the~     Philadelphia VA Medical Center and will be randomized to one of the two study arms.~      The immediate goal of this randomized controlled trial is to assess the effect of a~     high-quality, evidence-based, patient-centered educational intervention on African American~     patient preferences, expectations, and the likelihood of receiving a recommendation for knee~     joint replacement surgery when clinically indicated. The long-term goal of this research is~     to implement effective strategies to improve minority patients' access to joint replacement~     and ultimately eliminate racial disparities in the utilization of this effective treatment~     for knee OA.~      Study Aim: To examine the effect of the decision aid (DA) intervention on the likelihood of~     receiving a recommendation for knee joint replacement when clinically indicated. Hypothesis:~     The DA intervention will lead to higher rate of treatment recommendation within 6 months.~      Secondary Aim: To examine the effect of the DA intervention on the rate of knee replacement~     receipt within 12 months. Hypothesis: Patients randomized to receive the intervention will~     undergo knee replacement within 12 months at a higher rate than those in the attention~     control group.~   "
131068|NCT01851772|"~     The purpose of this study is to evaluate the safety, performance and usability of the Xoft~     Axxent Electronic Brachytherapy System and Cervical Applicator as incorporated into the~     physician's current standard treatment practice and in replacement of high-dose-rate~     after-loaders using Iridium-192 or low-dose-rate Cesium treatments. Data will be collected on~     treatment delivery, safety, and acute toxicity.~      Our hypothesis is that the treatment is safe as incorporated into the physician's current~     standard of practice.~   "
131069|NCT01851759|"~     Using placebo as control, The purpose of this study is to evaluate the efficacy and safety of~     methanesulfonic acid cinepazide injection to relieve disabled degree of acute cerebral~     infarction patients, and explore the best safe and effective dose as well as dose method.~   "
131070|NCT01851746|"~     The purpose of this study is to evaluate the effectiveness and security of lobaplatin~     combined with docetaxel in treatment of the sensitive recurrent ovarian cancer.~   "
131071|NCT01851733|"~     This pilot clinical trial studies magnetic resonance imaging (MRI)-guided laser surgery (MLA)~     and doxorubicin hydrochloride in treating patients with recurrent glioblastoma multiforme.~     The blood brain barrier (BBB) is a separation of circulating blood from the tissue of the~     central nervous system, preventing substances in the blood from entering the brain. MLA~     disrupts the BBB around the tumor which may allow cancer-killing substances to be carried~     directly to the tumor and the surrounding area. Using MLA prior to chemotherapy may result in~     a greater concentration of drug in the tumor to kill the cancer cells while limiting side~     effects.~   "
131072|NCT01851720|"~     Headaches associated with subarachnoid hemorrhage (SAH) cause severe pain. Headache~     management is complex, requiring a balance between pain control and preservation of~     neurological assessment. Sufficient pain control can be achieved with narcotics, however,~     these carry numerous undesirable side effects. Most critically, all narcotics can result in~     respiratory depression and sedation. For patients who present without neurological defects~     but debilitating pain, management is particularly challenging. The sedative effect of~     narcotics confounds the management of these patients by interfering with the neurological~     examination. Pain management is also a significant concern for patient's families as they~     observe suffering without full understanding of the importance of preserved mental status. In~     order to control the pain associated with SAH headaches, the use of narcotics is often~     required despite the risks. This standard therapy involves an IV bolus dose delivered by the~     provider regularly as needed for pain control. A common approach to reduce pain in other~     patient populations, including acute pain relief following major spine surgery, is patient~     controlled analgesia (PCA). With the PCA method, patients deliver low doses of narcotics~     through a pain pump with preset maximal doses and frequency of delivery. We hypothesize that~     this approach to pain relief for SAH headaches will result in lower pain scores, greater~     patient and family satisfaction scores, and increased patient safety with lower narcotic~     doses minimally interfering with neurological assessment.~   "
131073|NCT01851707|"~     The purpose of this study is to investigate the safety and efficacy of multiple dose levels~     of the investigational product (study drug), IPI-145, in combination with methotrexate~     compared to methotrexate alone in subjects with active moderate-to-severe Rheumatoid~     Arthritis.~   "
131074|NCT01851694|"~     In recent years, diabetes has emerged as one of the most significant co-diseases that many~     Cystic Fibrosis (CF) patients develop. Type 1 (T1D) and Type 2 (T2D) diabetes results when~     either the body does not make enough insulin or the body does not respond correctly to this~     insulin, respectively. Insulin is a hormone which is made by cells in the pancreas and helps~     carry glucose (sugar) from the food we eat to the cells of the body for energy. While cystic~     fibrosis related diabetes (CFRD) has many features similar to both T1D and T2D, patients with~     CF may not have the same symptoms as either T1D or T2D patients. Currently, there is little~     understanding of CFRD and the best options for treatment remain unclear.~      The purpose of this research study is to examine and understand the various mechanisms that~     contribute to CFRD and gain a better understanding of potential means to treat CFRD. In~     particular, we plan to study the effects of incretin hormones that can enhance insulin~     production in CF patients.~   "
131075|NCT01851681|"~     In order to prevent infections and complications, it has been initially established with the~     dental implant placement protocol that pre- and post-operative antibiotics should be~     prescribed to the patient receiving dental implants. There have been many antibiotic regimens~     used in the attempt to minimize the risks of infections and consequently, increasing the~     survival rate of dental implants placement procedures. However, issues about bacterial~     resistance have been raised recently concerning the extensive use of antibiotics. The primary~     objective of this study is to find out whether giving antibiotics before or after implant~     placement would significantly influence crestal bone loss around dental implants. One study~     group will receive one dosage of antibiotics before implant placement followed by~     post-operative intake of antibiotics for 7 days. Another group will receive the antibiotics~     in one single preoperative dose followed by an identical placebo for 7 days. Questionnaires~     for pain and interference with daily activities assessment to be filled for the first~     postoperative week will be distributed to participants. Signs of postoperative morbidity will~     be recorded at 1 and 3 weeks following the surgery, and both clinical and radiographic data~     will be collected at 4 months postoperative to assess the implants status. A radiographic~     follow-up will be done 1 year after the surgery. Peri-implant crevicular fluid levels of 3~     known immunological markers for bone loss (MMP-8, sRANKL and OPG) will be measured at 1-, 3-~     and 16-weeks follow-ups. The findings from this study might allow clinicians to establish the~     ideal antibiotic regimen with minimal risk exposure to bacterial resistance.~   "
131076|NCT01851668|"~     This is an observational pilot study to quantify the amount of vibration, noise,~     physiological and biochemical instability that premature babies are exposed to during~     inter-hospital transport.~   "
131077|NCT01851655|"~     This is a single-center, randomized, double-blind (subject/evaluator)study. Enrolled patients~     had anterior cruciate ligament (ACL) reconstruction and met criteria for advanced~     rehabilitation. The study included 8 weeks of advanced rehabilitation consisting of low- or~     high-intensity plyometric exercise. The objective of the study was to determine the effect of~     plyometric exercise intensity on knee function and knee cartilage in patients with ACL~     reconstruction.~   "
131078|NCT01851642|"~     The purpose of this study is to look at how Alpha-1-antitrypsin (AAT) deficiency and Cystic~     Fibrosis (CF) affect white blood cells in the lungs, called macrophages, and their ability to~     work.~   "
131079|NCT01851629|"~     The purpose of this study is: (1) to establish assessment techniques (in our laboratory) to~     identify the functional integrity of long spinal tracts associated with adaptive walking~     recovery post-spinal cord injury and (2) to preliminary investigate locomotor outcomes~     associated with an adaptive locomotor training approach post-spinal cord injury.~   "
131080|NCT01851616|"~     The objective of this study is to examine gastric emptying and satiety hormones after oral~     glucose stimulation in 2 different concentrations in morbidly obese patients after~     Roux-en-Y-gastric-Bypass.~   "
131081|NCT01851603|"~     This is a brief inpatient study to determine the safety of a new drug in healthy people.~   "
131082|NCT01851590|"~     The current study is conducted to corroborate the previous observational clinical trial with~     more valid methods and a more clinically relevant experimental design. This study aims to~     compare efficacy, safety, and cost between topically administered 30% resin lacquer for the~     treatment of dermatophyte toenail onychomycosis and the current best practices: topical 5%~     amorolfine and systemic terbinafine.~   "
131083|NCT01851577|"~     The purpose of this study is to determine the efficacy of Family Foundations that is to be~     delivered concurrently with home visiting. Delivered prenatally and postnatally, Family~     Foundations is a coparenting prevention program for new mothers and fathers that is designed~     to optimize child outcomes by teaching parents how to work together in raising their child.~     Using a randomized clinical trial design, families will be assigned to receive Family~     Foundations + home visiting or home visiting alone. A comprehensive assessment is~     administered at baseline and then at post-intervention, and 9 and 18 months later. It is~     hypothesized that families receiving Family Foundations will improve in their resolving of~     conflict from pre-intervention through follow-up. Additional anticipated outcomes are that~     those receiving the intervention will have more involved fathers, mothers and fathers will~     report less conflict, and children will have better emotional and behavioral outcomes~     relative to those who receive home visiting alone.~   "
131084|NCT01851564|"~     The mortality rates from Acute Variceal Haemorrhage remain significant and first line therapy~     may fail in 15-25% of patients. The self-expandable metal stent has been described in case~     series as having a very high efficacy at control of haemorrhage from oesophageal varices when~     used as rescue therapy. This randomised controlled trial aims to assess for any potential~     superiority of the stent over 'standard' endoscopic techniques as primary or rescue therapy~     for bleeding oesophageal varices.~   "
131085|NCT01851551|"~     This was a Phase 1/2 study performed at two clinical centers in the US and UK. It was a~     single arm, open label study evaluating VSLI plus rituximab in adults with aggressive~     relapsed or refractory non-Hodgkin's lymphoma.~   "
131086|NCT01851538|"~     The Bio-SHiFT study aims to investigate whether disease progression in individual patients~     with chronic heart failure (CHF) can be accurately assessed by serial measurements of~     disease-related (novel) biomarkers. Secondary objectives of the study include comparison of~     2D- with real-time 3D-echocardiography in CHF patients and comparison of Speckle tracking~     with tissue Doppler imaging (TDI) in CHF patients, and relating these echocardiographic~     measurements to clinical outcome.~      Bio-SHiFT is a prospective, observational, multi-center, cohort study in men and women, aged~     18 years or older, visiting the outpatient clinic. Blood samples are taken at the day of~     inclusion and at follow-up visits, which are performed every 3 months until the end of the~     scheduled follow-up. Clinical data are collected at baseline and at each 3-month follow-up~     visit. Echocardiography including TDI, Speckle tracking and 3D-echocardiography is performed~     in a subset of patients, at baseline and during follow-up at 6-month intervals. The primary~     endpoint is the composite of cardiovascular death, cardiac transplantation, left ventricular~     assist device implantation, and re-hospitalization for the management of acute or worsened~     heart failure.~   "
131149|NCT01850706|"~     The purpose of this study is to find a noninvasive test to help physicians diagnose detrusor~     overactivity (DO), to use this urine test to help diagnose bladder problems, determine if~     treatments are working, and determine if patients are good candidates for interventions like~     sacral neuromodulation/Interstim Therapy.~   "
131087|NCT01851525|"~     Catheter ablation has emerged as an effective therapy for atrial fibrillation (AF). However,~     achievement of complete& durable isolation of the pulmonary veins (PVs) is challenging,~     primary limited both by operator experience and also the limits of currently available~     ablation technology. Direct contact force sensing (CFS) is a novel technology that may help~     to ensure adequate lesion delivery. CFS may also help to improve the safety profile of~     catheter ablation. The purpose of this study is to compare two strategies of wide antral PV~     isolation plus linear ablation for persistent AF:~        1. guided by contact force sensing (CFS) OR~        2. blinded to contact force sensing (CFS) - i.e. standard approach~   "
131088|NCT01851512|"~     This is a single-blind, randomized, comparative, phase I study to evaluate the tolerability,~     safety and pharmacokinetic characteristics of human chorionic gonadotropin between two~     recombinant hCG products named DA-3803 injection and ovidrel liquid injection, in healthy~     subjects. The subjects will injected with these two injections at the the 21day-interval of~     time and their conditions including vital signs, blood, clinical examination will be~     carefully observed.~   "
131089|NCT01851499|"~     Randomized, double-blinded, placebo-controlled, parallel group study of ultramicronized PEA~     (Normast)600 mg x 2 daily or corresponding placebo with a week of baseline period followed by~     1 x 12 weeks treatment period.~   "
131090|NCT01851486|"~     The role of alpha2 receptor agonist on pain perception and modulation will be examined. In~     addition whether this is mediated through the opioid system will be examined. Pain perception~     and modulation will be examined before and after administration of Clonidine or placebo~     together with Naloxone or saline.~   "
131091|NCT01851473|"~     Background:~      - Scientists are studying medications that may be useful in treating cocaine addiction. It is~     important in these studies to know whether study participants are always taking their~     medications as directed. This study will look at two chemicals to see if they can be used to~     determine whether participants are taking their medications as directed. Because~     acetazolamide and quinine can be measured in plasma and urine, they are good test subjects~     for this study. They will be given alone, and combined with intravenous cocaine.~      Objectives:~      - To see how they body handles acetazolamide and quinine alone, and when combined with~     cocaine.~      Eligibility:~      - Individuals between 18 and 50 years of age who have smoked or used IV cocaine for at least~     one year and at least three times per month during the three months prior to screening. Urine~     test positive for cocaine within the prior 6 months~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will also be collected.~        -  This study will involve a 12-day inpatient stay at the National Institutes of Health.~        -  On days 1, 5, and 10, participants will receive a dose of cocaine. Blood, urine, breath,~          and saliva samples will be collected up to 18 times a day for up to about 24 hours.~        -  On days 2, 3, 4, and 5, participants will receive acetazolamide. Regular blood samples~          will be collected on Day 4.~        -  Day 6 is a wash-out day with no drugs or blood tests.~        -  On days 7, 8, 9, and 10, participants will receive quinine. Regular blood samples will~          be collected on Day 9.~        -  On day 11, blood, urine, breath, and saliva samples will be collected in the early~          morning. Participants will be able to leave later in the day.~   "
131092|NCT01851460|"~     Background:~      - Abscesses are a pocket of infection in an organ or tissue. Patients with a disease called~     chronic granulomatous disease (CGD) often develop these abscesses. CGD is an inherited~     disorder that affects how white blood cells function. Liver abscesses in people with CGD~     often require surgery to remove them and treat the infection. However, some people with CGD~     cannot have full surgery because it would be too risky. Researchers want to try a procedure~     called radiofrequency ablation (RFA) to treat these liver abscesses. RFA can usually be done~     without a major operation. This study will see if RFA is a safe and effective treatment for~     liver abscesses in patients with CGD.~      Objectives:~      - To see if RFA is a safe and effective treatment for CGD-related liver abscesses.~      Eligibility:~      - Individuals between 18 and 75 years of age with CGD who have liver abscesses that cannot be~     treated with surgery.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Imaging studies will be performed on the liver.~        -  Participants will have RFA for the abscesses. RFA is an image-guided technique that~          heats and destroys specific tissue, such as tumor tissue. It will target any abscesses~          on the liver.~        -  After the procedure, participants will stay in the hospital for monitoring before being~          released.~        -  Participants will have regular follow-up visits for up to 1 year after treatment. Blood~          and urine samples will be collected. Additional imaging studies will be performed.~   "
131093|NCT01851447|"~     Background:~      - Some kinds of muscular dystrophy affect the skeletal muscle membrane. In these conditions,~     the muscle membrane is more fragile. This affects how the muscles contract and relax, which~     causes movement problems. Researchers are looking at several muscle enzymes, or chemicals~     that affect how muscle cells function. By studying changes in these enzymes, they may be able~     to better understand how muscular dystrophy affects the cells. Researchers want to collect~     biomarkers (chemicals from blood samples) from people with fragile sarcolemmal muscular~     dystrophy. This information may provide better treatments for this condition.~      Objectives:~      - To study biomarkers that may affect the muscles of people with fragile sarcolemmal muscular~     dystrophy.~      Eligibility:~      - Individuals at least 18 years of age with fragile sarcolemmal muscular dystrophy.~      Design:~        -  Participants will be screened with a medical history and physical exam.~        -  Participants will be asked to come for four visits to the National Institutes of Health~          Clinical Center. The visits will be at least 2 months apart. Each visit will require~          participants to stay for 5 days at the clinical center.~        -  During each visit, participants will provide frequent small blood samples. These samples~          will be collected while at rest and after physical exercise.~        -  Participants will also have a physical therapy assessment. They will perform standard~          motor function tests and imaging tests (MRI, MRS). These tests may take up to 1 hour~          each time.~        -  Treatment will not be provided as part of this study.~   "
131150|NCT01850693|"~     This study is to evaluate the prevalence, plaque characteristics (plaque types, stenosis~     degree, remodeling) and predictors of coronary atherosclerosis in stroke patients with~     coronary CT angiography.~   "
131094|NCT01851434|"~     Background:~      - Optic neuritis often is a symptom of multiple sclerosis (MS). Many people who experience~     optic neuritis are later diagnosed with MS. MS disease activity seen on magnetic resonance~     imaging (MRI) scans is often greater than that seen in tests given during regular doctor's~     visits. Even though MRI is a helpful tool for studying optic neuritis and MS, more~     information is needed on how MS symptoms show up on MRI scans. Researchers want to use MRI~     scans to track changes in the optic nerve after an optic neuritis episode. This approach will~     help them study the relationship between optic neuritis and MS.~      Objectives:~      - To collect more information about the relationship between optic neuritis and multiple~     sclerosis.~      Eligibility:~        -  Individuals between 18 and 50 years of age who have new optic neuritis.~        -  Individuals between 18 and 50 years of age who have new symptoms of MS other than optic~          neuritis.~        -  Healthy volunteers between 18 and 50 years of age.~      Design:~        -  Participants will be screened with a physical exam and medical history. They may provide~          blood or urine samples.~        -  Participants with optic neuritis or other MS symptoms will have a baseline study visit.~          They will have a physical exam and full eye exam. To look for signs of MS, they will~          have evoked potential tests to see how the body responds to stimulation. They will also~          have an MRI scan to study any changes in the brain and optic nerves.~        -  After the first visit, participants will have steroid treatment for 5 days for the optic~          neuritis.~        -  Additional study visits will be given 1, 3, 6, 9, and 12 months after the baseline~          visit. The tests from the first visit, including the MRI scans, will be repeated at~          these visits.~        -  Healthy volunteers will have a baseline study visit. They will have a physical exam and~          full eye exam. They will have evoked potential tests to see how the body responds to~          stimulation. They will also have an MRI scan to study any changes in the brain and optic~          nerves.~        -  Healthy volunteers will have additional study visits 2 and 11 months after the baseline~          visit. The tests from the first visit, including the MRI scans, will be repeated at~          these visits.~   "
131095|NCT01851421|"~     Background:~      - Melanocortin receptors are proteins in the body that help send messages between body~     systems. One such receptor, the melanocortin 3 receptor (MC3R), is important for regulating~     body weight. Differences in MC3R can affect fat metabolism - or how the body handles fat.~     Some people who have changes in the MC3R genetic code are heavier than those who do not have~     these changes. These changes are found more often in African Americans. Researchers want to~     study the MC3R in African American adults to see how these changes may affect fat metabolism.~     They will look at overweight adults with either the most common genetic code for the MC3R or~     a rare variant.~      Objectives:~      - To study the role of the MC3R in body weight and fat metabolism.~      Eligibility:~        -  Healthy African American volunteers between 18 and 55 years of age.~        -  Volunteers must be overweight (body mass index at least 30 kg/m2) but weigh less than~          450 lbs.~      Design:~        -  The study consists of an outpatient screening visit and a 7-day inpatient visit with~          dietary studies.~        -  Participants will be screened with a physical exam and medical history. Blood samples~          will be collected. (Participants will need to fast for 10 hours before giving blood~          samples.) A body scan will be given to determine fat, bone, and muscle content.~          Participants will complete a 3-day dietary assessment to record their food and drink~          consumption. They will also have an exercise test to look at heart and lung function.~        -  Participants will have a 7-day inpatient stay. They will have a regular diet for the~          first 3 days of the study. For the final 4 days, they will have a diet with a higher fat~          content.~        -  During the inpatient visit, participants will have the following study procedures:~        -  Body measurements~        -  Daily exercise routine~        -  Imaging studies of the body~        -  Measurement of a whole day s energy expenditure (spending one day in metabolic~          chamber-day 5)~        -  Frequent blood samples~        -  Urine collection for 24 hours (days 3 and 7)~        -  Fat biopsy (collection of a small sample of fat tissue from under the skin on the~          abdomen)~        -  Insulin and metabolism tests while eating the two different diets (day 4 and day 7).~        -  After the final insulin and metabolism test, participants will be discharged from the~          study.~   "
131096|NCT01851408|"~     This phase II portion of the trial is studying the side effects and best dose of temsirolimus~     when given together with sorafenib and to see how well they work in treating patients with~     metastatic, recurrent, or unresectable melanoma. Sorafenib and temsirolimus may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib may~     also stop the growth of tumor cells by blocking blood flow to the tumor. Giving sorafenib~     together with temsirolimus may kill more tumor cells.~   "
131097|NCT01851395|"~     Background:~      - People with lung cancers unfortunately commonly succumb to their disease. Some agree to~     donate their bodies to cancer research that may help the medical community better understand~     these diseases. Studies of lung cancer tumor tissue obtained soon after death may be used to~     answer questions about the origins, progression, and treatment of lung cancer. Researchers~     want to conduct a study that involves planned collection of lung cancer tumor tissue shortly~     after death. To do so, they will arrange to provide inpatient hospice care for people with~     non-small cell lung cancer.~      <TAB>~      Objectives:~      - To collect lung cancer tissue biopsy samples as soon as possible after death.~      Eligibility:~      - Individuals who have non-small cell lung cancer and are planning to receive end-of-life~     hospice care.~      Design:~        -  Participants will agree to receive inpatient hospice care at the National Institutes of~          Health Clinical Center. Full details on end-of-life instructions will be noted.~        -  An autopsy will be performed at the clinical center within 3 hours of death. Tumor~          tissue will be collected from the primary site of cancer and from any areas of the body~          to which the cancer has spread.~        -  Participants will not receive further cancer treatments as part of this study. This is a~          tissue collection study only.~   "
131098|NCT01851382|"~     Background:~      - Researchers often collect samples from healthy volunteers to further their research. These~     samples can help better understand serious side effects and complications of transplant~     treatments in patients. This study will collect saliva samples from healthy volunteers.~      Objectives:~      - To collect saliva and blood samples from healthy volunteers for research studies.~      Eligibility:~      - Healthy men ages 30-70 years for Phase I of the study.~      Design:~        -  Participants will be screened with a medical history questionnaire. They will also have~          a brief oral exam to check for any mouth infection.~        -  Participants will provide a saliva sample. The collection process will take about 5~          minutes.~        -  No treatment will be given as part of this study.~   "
131099|NCT01851369|"~     Background:~      - TRC102 is a new cancer treatment drug that may help improve the results of chemotherapy. It~     blocks tumor cells' attempts to repair damaged DNA, which may allow chemotherapy to kill the~     cells more easily. Researchers want to see how well it works with temozolomide, a~     chemotherapy drug that is designed to damage tumor cell DNA. These drugs will be given to~     people who have advanced solid tumors or lymphomas that have not responded to earlier~     treatments.~      Objectives:~      - To test the safety and effectiveness of TRC102 and temozolomide for advanced solid tumors~     and lymphomas.~      Eligibility:~      - Individuals at least 18 years of age who have advanced solid tumors or lymphomas that have~     not responded to earlier treatments.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Tumor samples may also be collected. The size and location of~          the tumors will be determined with imaging studies.~        -  Participants will take TRC102 and temozolomide for 28-day cycles of treatment. They will~          take temozolomide and TRC 102 by mouth once a day on days 1-5. Participants will keep a~          diary to record doses and any side effects.~        -  Treatment will be monitored with frequent blood tests and imaging studies. Tumor samples~          will also be collected.~        -  Participants will continue their treatment as long as the cancer does not grow and there~          are no severe side effects.~   "
131151|NCT01850680|"~     Primary Objective:~      To assess the safety and tolerability of a single dose of subcutaneously administered~     sarilumab in Japanese patients with rheumatoid arthritis (RA) who are receiving concomitant~     treatment with methotrexate.~      Secondary Objective:~      To assess the pharmacokinetic profile of a single subcutaneous (SC) dose of sarilumab in~     Japanese RA patients.~   "
131100|NCT01851356|"~     Background:~      - Studies have shown that inflammation plays an important role in depression. Brain~     inflammation may contribute to depression, and may make it more difficult to treat some kinds~     of depression with current therapies. Researchers want to use magnetic resonance imaging~     (MRI) and positron emission tomography (PET) scanning to study inflammation in the brain. To~     do so, they will use a contrast agent, which is a chemical that can show inflammation during~     an imaging study.~      Objectives:~      - To see if people with major depressive disorder have increased inflammation in the brain.~      Eligibility:~      - Individuals at least 18 years of age who have major depressive disorder.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will~          provide blood samples before the scanning sessions.~        -  Participants will have a PET scan after the screening visit. They will have a dose of~          the contrast agent before the study. This scan will look for possible brain~          inflammation.~        -  Participants will also have an MRI scan. This scan will take pictures of the brain for~          comparison studies.~        -  Treatment will not be provided as part of this study.~   "
131101|NCT01851343|"~     Background:~      - Bone marrow stromal cells (BMSCs) are cells that can develop into other tissue types,~     including bone, cartilage, marrow, and blood cells. However, BMSCs are not stem cells there~     is no evidence that after infusion into another person that BMSCs change into any other~     cells. Research suggests that BMSCs can travel to different parts of the body and work with~     immune cells to reduce inflammation and help repair damaged tissues. BMSC infusions have been~     used in tests to treat moderate to severe inflammatory bowel disease, like Crohn's disease~     (CD) or ulcerative colitis (UC). These tests have shown some good results, but more research~     is needed to study their safety and effectiveness. Researchers want to see how well BMSC~     infusions work to treat CD and UC. The BMSCs will be collected from volunteer donors.~      Objectives:~      - To look at the safety and effectiveness of BMSC infusions for moderate to severe CD and UC.~      Eligibility:~      - Individuals between 18 and 65 years old with moderate or severe inflammatory bowel disease~     (CD or UC) that has not responded to standard treatment.~      Design:~        -  Participants will have two screening visits. The first will be 15 to 30 days before the~          first BMSC infusion. The second will be within 14 days of the first BMSC infusion.~        -  At the first screening visit, participants will have a physical exam and medical~          history. They will provide blood, urine, and stool samples. They will also give~          information about their symptoms and quality of life.~        -  At the second screening visit, participants will have their vital signs (like blood~          pressure and heart rate) measured. They will also provide blood samples, and have a~          colonoscopy with biopsies.~        -  During treatment, participants will have one BMSC infusion per week for 4 weeks. Blood~          and urine samples will be collected at each treatment visit.~        -  One week after the last infusion, participants will have a study visit. The tests from~          the first and second screening visits will be repeated.~        -  There will be six follow-up visits at 1, 2, 3, 6, 12, and 24 months after the last study~          visit. Participants will repeat the tests from the first screening visit.~   "
131102|NCT01851330|"~     This study is to evaluate the safety, tolerability, and antiviral efficacy of~     ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV)~     administered for 8 or 12 weeks in treatment-naive participants with chronic genotype 1 HCV~     infection.~   "
131103|NCT01851317|"~     This study is designed to investigate the relationship between patients' position and~     endotracheal tube intracuff pressure in the pediatric population.~   "
131104|NCT01851304|"~     A diet high in easily obtained energy-dense foods leads to the problems of overweight and~     obesity common in the developed world. Foods enriched with fiber or bitter compounds may~     increase satiety and decrease energy intake. This intervention will measure the effectiveness~     of coffee melanoidins, bread melanoidins, beta-glucans, and a Gentiana lutea L. extract in~     both a free or encapsulated form to decrease energy intake and modify the physiological~     markers of satiety in the short term. In particular bread (fiber) and a pudding (Gentiana~     lutea L. extract) will be used as tasty food matrices in the study.~   "
131105|NCT01851278|"~     The purpose of this study is to compare the small and large dose of corticosteroid used in~     intraarticular injection of wrist.~   "
131106|NCT01851265|"~     This is a 2 part study for patients with solid tumours. The purpose of Part A is to measure~     the amount of olaparib or its breakdown products in the bloodstream for up to 72 hours after~     eating 3 different breakfasts (high calorie, regular and none). In Part B Patients can take~     olaparib capsules daily and study assessments will be recorded for 6 months (minimum).~     Treatment can continue for as long as the patient is benefitting. Throughout the study~     patients will be monitored for any side effects.~   "
131107|NCT01851252|"~     The purpose of this study is to determine the effect on the (carbon 13~     labelled(13C)-Methacetin Breath Test (MBT) of i.v. propranolol, a non-selective beta blocker~     (NSBB) following initial administration and after chronic use of each of these agents. The~     correlation of the MBT with Hepatic Venous Pressure Gradient (HVPG) measurement before and~     after treatment will be assessed. Additionally, the MBT measurements following 60 days of~     therapy will be compared to the first MBT measurement and to the second MBT measurement, post~     HVPG. Each patient's subsequent MBT measurement will be compared to his previous MBT results~     in order to determine his/her response to therapy.~   "
131108|NCT01851239|"~     Venous thromboembolism(VTE) is the third most common cardiovascular complication among~     hospitalized patients, and can even cause death. VTE often occurs in intensive care patients~     and there had been many efforts to prevent such complication. The American College of Chest~     Physicians (ACCP) had published evidence-based clinical practice guideline for VTE~     prophylaxis.~      This study focuses on how VTE prophylaxis is being performed in both medical and surgical~     ICUs in a single University hospital, and sees the differences in such prophylactic patterns.~   "
131109|NCT01851226|"~     Endoscopic retrograde cholangiopancreatography (ERCP) is one of the most difficult techniques~     in the field of GI endoscopy. It is necessary for trainees to spend enough time and perform~     enough cases to grasp this technique. The methods of ERCP training include hands-on teaching,~     training on different kinds of simulators, training on ex-vivo or live anesthetized porcine~     stomach models, etc. Supervised hands-on teaching is the standard method for ERCP training.~      Selective cannulation is considered the most difficult and challenging part of learning ERCP.~     There is not an optimal time for trainees to attempt cannulation during hands-on ERCP~     training. The time used for attempting cannulation by trainees was 5min or 10min in several~     centers. In ERCP center of the investigators hospital, 15min was used for trainees to attempt~     cannulation for about one year. The incidence of post-ERCP pancreatitis, the major~     complication related to cannulation, was 4.0%, which was comparable with previous studies.~      The investigators hypothesized that a longer time (15min) for trainees to attempt cannulation~     would increase success rate of selective cannulation and help to improve skills more quickly.~     At the meantime, with actively verbal or hands-on assistance from the instructor during~     performance of trainees, the risk of complications would not increased with a longer time to~     attempt cannulation. Here a prospective, endoscopists-blinded, randomized, controlled study~     was designed to evaluate the effects of different periods of time for trainees to attempt~     selective cannulation on success rate of cannulation, self-satisfaction of performance and~     post-ERCP pancreatitis.~   "
131110|NCT01851213|"~     This study is a prospective, multicenter, observational study to characterize utilization~     patterns of the FoundationOne™ test by oncologists under conditions of routine clinical~     practice in the US. The study will also examine impact of test results on subsequent clinical~     decisions regarding choice of therapy. The planned duration of the study is at least 2 years~     with 1 year for patient recruitment and a minimum 1-year follow-up period for each patient.~     Any patient for whom the treating physician has ordered a FoundationOne™ test and a report is~     delivered is eligible for participation on the study. Eligible patients from participating~     sites will be enrolled sequentially during the 1-year enrollment period. Sites will be~     required to maintain an enrollment log of all patients for whom the FoundationOne™ test has~     been ordered and document patient disposition and reasons for non-participation. All~     treatment decisions and clinical assessment will be made at the discretion of the treating~     physician per usual care and are not mandated by study design or protocol. Informed consent~     will be obtained from eligible patients prior to study entry.~   "
131111|NCT01851200|"~     The purpose of the study is to assess the activity of Brentuximab vedotin in refractory germ~     cell tumors.~   "
131112|NCT01851187|"~     Pregnancy or childbirth is a kind of persistent and strong source of stress for pregnant~     women. Prenatal and intrapartum negative emotions not only damage the mental health of~     pregnant women, but also have a negative impact on the mode of delivery, labor, postpartum~     complications and neonatal outcomes . Due to considerations for the effect on the fetus,~     there is concern of the use of drug treatment for depression during pregnancy. Therefore,~     psychological interventions have an important role. According to the WHO global survey in~     Asia 2007-08, China had the highest overall rate of caesarean section (46.2%), and also had~     the highest rate of caesarean section without indication (11.7%). The embarrassing first in~     the world of caesarean section rate was causing widespread concern in China. Recently, the~     Chinese government has launched a project named promoting the rate of natural childbirth and~     protecting the health of mother and child, trying to reduce the cesarean section rate~     especially that without medical indication. Therefore, examining if emotional management is~     effective in reducing negative emotions of pregnant women as well as decreasing the rate of~     cesarean section is an important research question. Our study aims to help the pregnant women~     control their anxiety, depressive feelings and other negative emotions by emotional~     self-management group training and we examine if this can reduce the incidence of depression~     and improve delivery outcomes.~   "
131113|NCT01851174|"~     To determine whether the occurrence of adverse events can be decreased by moving to a~     bi-weekly schedule of gemcitabine plus nab-Pacitaxel for the treatment of~     unresectable/metastatic pancreatic cancer.~   "
131114|NCT01851161|"~     This clinical trial studies prone patient positioning in reducing tumor motion and improving~     breathing reproduction in patients with lung cancer undergoing radiation therapy. Prone~     patient positioning during radiation therapy may help kill tumor cells without harming normal~     tissue.~   "
131115|NCT01851148|"~     The aim of the present study is to determine the extend to which OMT is effective on a sample~     of subjects affected by migraine evaluated using the headache impact test (HIT-6)~     questionnaire.~   "
131116|NCT01851135|"~     The main objective of the study is to investigate the determinants of the quality of life in~     children and adults with Neurofibromatosis type 1 (NF1) and more particularly the specific~     impact of neuropsychological deficits. In fact, cognitive impairment is currently considered~     as one of the most pervasive features of this genetic disorder but its relationship with the~     worsening of quality of life found in this population has not been directly investigated to~     date.~      Secondary objectives of this study are (i) to compare neuropsychological and quality of life~     measures between patients and healthy controls matched by age, gender and education level,~     (ii) to contrast neuropsychological deficits incidence between patients and controls, and~     (iii) to differentiate NF1 children's self versus hetero-assessment of quality of life.~      The main hypothesis of this study is that the neuropsychological impairment classically~     identified in this clinical population will be associated to the quality of life's worsening~     both in children and adults.~   "
131117|NCT01851122|"~     The amino acid l-theanine (the active ingredient in green tea) is considered to have a~     calming effect without causing sleepiness. This study evaluates whether l-theanine affects~     blood pressure, heart rate, alertness, and sense of well-being.~   "
131118|NCT01851109|"~     The primary purpose of this study is to evaluate the effect of systematic identification and~     genetic counseling referral on rates of bilateral salpingo-oophorectomy (surgery to remove~     both fallopian tubes and ovaries) in women having mammograms at Swedish Medical Center in~     Seattle, WA.~   "
131119|NCT01851096|"~     Heat shock protein 90 (Hsp90) is a chemical in the body that is involved in the promotion of~     cancer. SNX-5422 is an experimental drug that blocks Hsp90.~   "
131120|NCT01851083|"~     Pediatric severe traumatic brain injury (TBI) is the leading cause of death and disability in~     children ages 1-14 years old. There are no effective therapies to treat secondary brain~     injury and the post-injury response of CNS apoptosis and neuroinflammation. This study is a~     follow-up trial from a previously performed Phase I trial that demonstrated the safety and~     potential CNS structural preservation effect of intravenous autologous bone marrow~     mononuclear cells (BMMNC) after severe TBI in children. (Cox, 2011) The study is designed as~     a prospective, randomized, placebo controlled, blinded Phase 2 safety/biological activity~     study. The investigators hope to determine the effect of intravenous infusion of autologous~     BMMNCs on brain structure and neurocognitive/functional outcomes after severe TBI in~     children.~   "
131121|NCT01851070|"~     Study is a double-blind, randomized, placebo controlled, dose escalating study. The primary~     objective of this study is to evaluate the safety, tolerability and feasibility of a single~     intravenous infusion of allogeneic mesenchymal precursor cells (MPCs) compared to placebo at~     12 weeks post-infusion in the treatment of patients with active rheumatoid arthritis (RA) who~     have received methotrexate +/- other DMARDs for at least 6 months prior to screening and who~     have had an incomplete response to at least one TNF-alpha inhibitor.~   "
131163|NCT01850524|"~     This is a phase 3, randomized, double-blind, multicenter study to evaluate the safety and~     efficacy of IXAZOMIB versus placebo when added to lenalidomide and dexamethasone (LenDex) in~     patients with Newly Diagnosed Multiple Myeloma (NDMM) who are not eligible for stem cell~     transplant.~   "
131122|NCT01851057|"~     Fifty-eight percent of children with new-onset epilepsy do not take their antiepileptic drugs~     (AEDs) as prescribed (i.e., non-adherence). Non-adherence, which is modifiable, is associated~     with continued seizures, mortality, poor quality of life, and high healthcare costs. There~     are no adherence interventions for young children with epilepsy and their families; thus, the~     current proposal examines a family-based behavioral treatment focused on improving epilepsy~     knowledge and problem-solving around barriers to adherence in young children with epilepsy~     and their families with the goal of improving adherence and ultimately, seizures and quality~     of life. It is hypothesized that children with newly diagnosed epilepsy and their families~     who participate in the problem-solving intervention will have significant improvements on~     adherence compared to those in the education only intervention.~   "
131123|NCT01851044|"~     The purpose of this study is to compare the effects of platelet rich plasma, whole blood and~     saline vehicle on the natural course of lateral epicondylitis.~   "
131124|NCT01851031|"~     The aim of the study was to compare the new approach and the retromandibular approach, so~     that the therapeutic effect and the advantages of the new approach would be clear.~   "
131125|NCT01851018|"~     The purpose of this study is to compare toxicities between 2 external beam radiation~     fractionation schemes plus a brachytherapy boost for prostate cancer. Our current standard~     use a 2 Gy per fraction schedule which is compare to the experimental hypofractionated 3 Gy~     per day approach with neo adjuvant hormonal therapy. It will demonstrate the feasibility and~     safety of such a treatment regimen in prostate cancer. It may also set base for a larger~     randomized trial.~   "
131126|NCT01851005|"~     Emergence of elderly patients from anesthesia may face with cognitive dysfunction or~     agitation such as delirium. There are reports that using dexmedetomidine as a adjuvant for~     general anesthesia decreased emergence-agitation in children and dexmedetomidine may be used~     for treating deliriums. Thus, we thought that dexmedetomidine as a adjuvant agent may be a~     help to smooth emergence from anesthesia in elderly.~      The aims of this study were to investigate the recovery characteristics (time to recovery of~     consciousness (ROC) and recovery, bispectral index (BIS) values at ROC and orientation, and~     Ricker sedation-agitated scale at the postanesthetic care unit) and safety (vital signs~     during and after administration of dexmedetomidine) of dexmedetomidine in elderly patients~     undergoing elective surgery.~   "
131127|NCT01850992|"~     The purpose of this study is to identify the mechanism(s) by which OSA exacerbates the~     age-linked decline in systemic testosterone concentrations by conducting a randomized order~     sham-controlled crossover study that dynamically evaluates the entire hypothalamic-pituitary~     testicular axis across a wide age range.~   "
131128|NCT01850979|"~     Aqueous deficiency dry eye is mainly caused by Sjogren syndrome (SS), an autoimmune, chronic,~     inflammatory and systemic disease which affects most commonly the lacrimal and salivary~     glands.The ocular treatment is focused in increasing lubrification and decreasing~     inflammation with topical autologous serum, topical immunosuppressive agents and~     corticotherapy. Use of topical immunosuppressants has increased in recent years because the~     topical corticotherapy leads to ocular complications. The most used immunosuppressant is~     cyclosporine. Tacrolimus , another immunosuppressant, has been used in treatment of immune~     and inflammatory ocular diseases.This study describes a prospective controlled double-blinded~     randomized study of the clinical outcome of SS dry eyes patients treated with 0.03%~     tacrolimus eye drops. As secondary purposes, outcome of dry eye symptoms and any ocular~     symptoms of the eye drops were also questioned to the patients.~   "
131129|NCT01850966|"~     To investigate the safety and efficacy of the administration of Iguratimod (CRM01T) for 52~     weeks in patients with rheumatoid arthritis in clinical practice~   "
131130|NCT01850953|"~     The objective of this study is to determine the mechanisms by which varenicline, an effective~     smoking cessation treatment, protects against relapse. Varenicline will be administered in~     smokers with schizophrenia and control smokers using a randomized, double-blind, cross-over~     design. Smokers will be asked to stop smoking overnight; the next day the ability to resist~     smoking will be assessed in a laboratory smoking lapse paradigm. Measures of tobacco craving,~     reinforcement and withdrawal-related cognitive dysfunction will be correlated with time to~     lapse. The results could have significant clinical implications by identifying mechanisms by~     which smokers with schizophrenia are at more risk for relapse than the general population,~     leading to the development of more effective smoking cessation therapies.~   "
131131|NCT01850940|"~     This is a phase IV, open-label, prospective cohort study for 7 days.The recommended starting~     dose of tolvaptan is 15 mg daily orally. The dose may be titrated on the next day at 15 mg~     intervals up to 60 mg daily according to the serum sodium level response.Serum sodium level,~     change in sodium level from baseline, quality of life (EQ-5D-3L), change in body weight,~     edema, renal function, mortality and liver-related complications on day 7 and day 30 to~     evaluate the efficacy of tolvaptan in cirrhotic patients with hyponatremia.~   "
131132|NCT01850927|"~     Recent data suggests that subclinical myocardial injury occurs in patients undergoing major~     abdominal surgery, and the degree of damage is proportionally linked to morbidity and~     mortality in the short and medium terms. Therefore, new methods of limiting myocardial damage~     are urgently needed.~      Ischemic preconditioning is a phenomenon whereby a brief non-lethal ischemia-reperfusion~     stimulus gives a protective effect to further ischemic insults. In remote ischemic~     preconditioning (RIPC), this initial stimulus is carried out away from the region of~     interest, normally a limb. In meta-analysed syntheses the effect size of RIPC in reducing~     cardiac damage during bypass grafting, as characterised by troponin release, seems to be~     about 35%.~      The PRIME Study will assess the value of RIPC in reducing subclinical myocardial injury in~     patients undergoing major abdominal surgery. Post-operative troponin release will be used as~     a surrogate marker of myocardial damage. There is no good data on which to build a reliable~     sample size calculation, therefore we estimated samples sizes using supplementary data from~     the recent VISION study. The investigators intend to build a clinically powered study from~     the results of this study.~      Study design will be by single-centre single-blind randomised control trial. Allocation will~     be 1:1. All treatments will be carried after induction of anaesthesia, prior to surgery. In~     the RIPC-treatment group, a blood pressure cuff inflated on an upper limb to 200mmHg for 5~     minutes, and then deflated for 5 minutes, repeated in three cycles. In the control group, the~     blood pressure cuff will not be inflated, but the patient will remain under anaesthesia for~     the same amount of time.~      Primary endpoint will be peak post-operative 5th generation hs-TnT (highly sensitive~     Troponin-T, ng/ml). Secondary endpoint will be hs-TnT area-under-the-curve, major adverse~     cardiovascular events, serious surgical complications, non-cardiovascular death, quality of~     life, and length of stay.~   "
131166|NCT01850485|"~     The hypothesis is: In patients after an out of hospital cardiac arrest, treated with~     therapeutic hypothermia (33°C) will be found significantly more microcirculatory~     abnormalities, compared to the same group of patients treated with 36°C.~   "
131133|NCT01850914|"~     Idiopathic normal pressure hydrocephalus (INPH) is a treatable and a common disease of the~     elderly. The overall objective of this work is to describe cardio- and cerebrovascular risk~     factors and vascular disease in shunted INPH-patients compared to an age- and sex matched~     elderly population, as well as the impact of vascular risk factors and vascular co-morbidity~     on clinical symptoms and outcome of surgery in INPH-patients. The hypothesis is that~     INPH-patients have a higher level of vascular risk factors and subclinical organ damage than~     a normal elderly population, and that the higher the level of existing vascular risk factors,~     the more severe the symptoms of the hydrocephalic disease.~   "
131134|NCT01850901|"~     The aim of this study is to assess whether renal denervation (RD) added to usual care~     compared to usual care alone reduces blood pressure (BP) as determined with ambulatory BP~     monitoring (ABPM) after 6 months in subjects with an average day-time systolic BP of at least~     135 mmHg as determined with use of ABPM, despite use of three or more BP lowering agents or~     with documented intolerance or contraindication for to 2 or more of the 4 major classes of~     antihypertensive drugs (ACEi/ARB, calcium channel blockers, betablockers and diuretics)~     obstructing use of 3 antihypertensives~      Further aims are to assess the effect of renal denervation on the use of BP lowering agents,~     to explore the effect of renal denervation in strata of estimated glomerular filtration rate~     (eGFR) (eGFR 20-60 mL/min per 1.73m2 and eGFR>60 mL/min per 1.73m2) and according to baseline~     office BP.~      Randomization will be stratified by hospital and eGFR and will be at a 2:1 ratio.~   "
131135|NCT01850888|"~     This is a best available therapy/compassionate use single institution study designed to~     determine the palliative benefit and toxicity of 131I-MIBG in patients with progressive~     neuroblastoma and metastatic pheochromocytoma who are not eligible for therapies of higher~     priority. Patients may receive a range of doses depending on stem cell availability and tumor~     involvement of bone marrow. Response rate, toxicity, and time to progression and death will~     be evaluated.~   "
131136|NCT01850875|"~     The study explores the feasibility of Eye-Movement-Desensitization and Reprocessing (EMDR) in~     non-specific chronic back pain.~   "
131137|NCT01850862|"~     The investigators hypothesized that an eight-week collective group exercise program would~     improve pain, quality of life and functional capacity in patients with knee osteoarthritis~     (KOA) compared with those receiving no exercise intervention.~   "
131138|NCT01850849|"~     The principle aim of this study is to obtain safety, tolerability and pharmacokinetic data~     when LEO 39652 cream is administered cutaneously as single dose to subjects with atopic~     dermatitis and to healthy subjects.~   "
131139|NCT01850836|"~     To investigate the therapeutic effect of dual hemisphere repetitive transcranial magnetic~     stimulation (rTMS) on post-stroke non fluent aphasia.~   "
131140|NCT01850823|"~     A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Site Study to Compare~     the Clinical Equivalence of Mometasone Nasal Spray (Watson Laboratories, Inc) with NASONEX®~     Nasal Spray (Schering Corporation) in the Relief of the Signs and Symptoms of Seasonal~     Allergic Rhinitis~   "
131141|NCT01850810|"~     The objective of this trial is to evaluate a nutritional product for people with Diabetes.~   "
131142|NCT01850797|"~     The registry of acute stroke under new oral anticoagulants (RASUNOA) is a German multicenter,~     prospective, observational registry performed at about 50 study centers covering about 50.000~     acute ischemic strokes and 6000 acute intracranial hemorrhages per year. Study enrollment~     will be consecutive. The RASUNOA registry study center is the University Medical Center of~     the Principal Investigator (Heidelberg, Germany). The registry will focus on treatment~     decisions and concepts in patients being under treatment with a new oral anticoagulant and~     suffering from acute ischemic or hemorrhagic stroke.~   "
131143|NCT01850784|"~     High energy formula more positively affect growth in infants with congenital heart disease~     compared to standard formula~   "
131144|NCT01850771|"~     The primary objective of this study is to compare the improvement in subject-reported~     clinical outcomes for Regenexx PL-Disc vs. steroid epidural for treatment of lumbar~     radiculopathy, from baseline to 3 months, with continued evaluation of efficacy and~     durability up to 12 months.~      Secondary objectives include incidence of post-operative complications, adverse events,~     re-injections, and surgical intervention; change in pain score and use of pain medications.~   "
131145|NCT01850758|"~     The primary objective of this study is to compare the improvement in subject-reported~     clinical outcomes for Regenexx SD vs. Exercise Therapy treatment of partial and complete,~     non-retracted knee ACL ligament tears, from baseline to 3 months, with continued evaluation~     of efficacy and durability up to 24 months.~      Secondary objectives include evaluation of MRI evidence of tendon repair; incidence of~     post-operative complications, adverse events, re-injections, and surgical intervention;~     change in pain score and use of pain medications.~   "
131146|NCT01850745|"~     Adherence to antiviral treatment in chronic hepatitis C (CHC) is an important factor to~     achieve sustained virological response (SVR). The aim of our study is to evaluate the~     efficacy of a multidisciplinary support program (MSP) in adherence to and efficacy of~     pegylated interferon alfa-2a and ribavirin compared to the conventional approach. We assessed~     447 patients with CHC receiving antiviral treatment distributed into 3 groups: control group~     (recruited 2002-2004, n= 147), MSP-pilot group (recruited 2005-2006, n=131), and~     MSP-validation group (recruited 2007-2009, n=169).~   "
131147|NCT01850732|"~     The purpose of this study is to investigate the prevalence of abdominal aortic aneurysms~     (AAA) among male patients with transient ischemic attack (TIA) symptoms. Ethiology of AAA is~     known to be common with atherosclerotic arterial diseases (coronary artery disease,~     peripheral artery disease and carotid artery disease), so the hypothesis is that AAA should~     be more common among these TIA patients, thus making screening of these patients (for AAA)~     more cost-efficient.~      Study will be carried out as a prospective screening study. Data will be collected in North~     Karelia Central Hospital within one year. All male patients with TIA symptoms will be~     recruited for the study and screened for AAA with ultrasound.~   "
131148|NCT01850719|"~     The purpose of this study is to determine the effectiveness of both arthroscopic knee surgery~     and physical therapy in the treatment of non-obstructive meniscal injuries in older patients.~      The investigators assume equal improvement of physical function in both groups and reduced~     costs with conservative treatment.~   "
131152|NCT01850667|"~     The standard treatment for hepatocellular carcinoma (HCC) is surgery, such as, by hepatic~     resection or liver transplantation, but less than 20% of HCC patients are suitable for~     surgery. In the remaining patients with inoperable and advanced HCC, trans-arterial~     chemo-embolization (TACE) has been widely used but TACE alone rarely produces complete~     response and commonly develops recurrence. Recently several small studies reported high tumor~     response and local control rate after stereotactic body radiotherapy (SBRT) alone or with~     TACE for inoperable HCC. A single institution phase II trial with SBRT for inoperable HCC~     after incomplete TACE at Korea Cancer Center Hospital showed promising results: the overall~     response rate of 73% and 2-year local control rate of 95%. They reported severe~     gastrointestinal toxicity of 11% because there was no normal tissue constraint for~     gastrointestinal tract and dosage to gastrointestinal tract was restricted to the lowest~     levels possible. In addition, they found that the presence of gastroduodenal ulcer before~     SBRT was significantly influenced on severe gastrointestinal toxicity. Based on this study,~     we will conduct a multicenter phase II trial on maintenance of treatment results and~     reduction of severe treatment related toxicity below 5%. To achieve this, we strictly apply~     normal tissue constraints. Secondly, we will do Esophagogastroduodenoscopy (EGD) before SBRT~     to evaluate gastroduodenal ulcer. After then, we will apply the normal tissue constraint of~     gastrointestinal tract according to gastroduodenal ulcer.~   "
131153|NCT01850654|"~     The purpose of the Ohio Colorectal Cancer Prevention Initiative (OCCPI) is to reduce~     morbidity and mortality due to colorectal cancer (CRC) in the state of Ohio. By identifying~     individuals at high-risk for CRC (genetically predisposed) and providing screening~     recommendations for cancer risk reduction, the OCCPI will understand how to increase length~     of life and quality of life for those diagnosed with CRC in Ohio, as well as to better~     prevent CRC in others in Ohio.~      Participants will have free tumor screening for Lynch syndrome, and may be eligible for free~     genetic testing and free genetic counseling as part of this study.~   "
131154|NCT01850641|"~     The purpose of this study is to investigate the safety and efficacy when administering PA21~     with calcium carbonate in hemodialysis patients with hyperphosphatemia for 12 weeks.~   "
131155|NCT01850628|"~     This study is a biospecimen discovery project that will serve as a pilot for a comprehensive~     'omics approach using fresh core biopsy tissue and blood samples for DNA and protein~     analysis, as well as paired tumor-normal exome DNA and RNA sequencing.~   "
131156|NCT01850615|"~     This trial is conducted in Asia, Europe, South America, and the United States of America~     (USA).~      The aim of the trial is to investigate efficacy and safety of FIAsp in a basal-bolus regimen~     versus basal insulin therapy, both in combination with metformin in adult subjects with type~     2 diabetes.~   "
131157|NCT01850602|"~     The purpose of this study is to evaluate the efficacy and safety of PA21 in hemodialysis~     patients with hyperphosphatemia~   "
131158|NCT01850589|"~     The aim of this study is to prove that the use of Bupropion with counseling works better than~     counseling alone for patients to quit smoking. The belief is that overall, there is a small~     percentage of patients who quit smoking all together.~   "
131159|NCT01850576|"~     Public health programs and policies have utilized the combination prevention model of~     bringing together tailored, proven interventions in order to reduce the global impact of HIV.~     Project TEACH-Kenya adapts two effective HIV interventions, Project BRIEF (Behavioral~     intervention, Rapid HIV test, Innovative video, Efficient cost and health care savings,~     Facilitated seamless care) and STEP (Skill-based Teenage Education Program for HIV~     prevention) to increase HIV testing and counseling rates, implement proven risk reduction~     programs, and improve rates of linkage to care and ART initiation among adolescents in Kenya.~     The collaboration with St. Francis Community Hospital and input from the Kasarani community~     will increase the breadth, reach, and impact of this HIV prevention intervention in Kenya.~   "
131160|NCT01850563|"~     Patients with brain metastases who are candidates for treatment with stereotactic~     radiosurgery (SRS) are potential study participants. SRS delivers high-energy,~     precisely-focused radiation to each brain metastasis to shrink the tumor, and is the~     standard-of-care for patients with these tumors. Oxygen enhances the damaging effects of~     radiation on tumor cells. Hyperbaric oxygen (HBO) therapy increases oxygen levels in all~     kinds of tissues, including tumors. The purpose of this trial is to study whether it is~     feasible to treat patients with HBO just prior to receiving SRS, given the timing constraints~     of treating sequentially with HBO and then SRS. Patients will undergo HBO treatment followed~     by the placement of a Gill-Thomas-Cosman head frame then transported ,via stretcher, to~     receive SRS. The transfer and placement of the head frame needs to be completed within the~     15minute time frame. The trial's secondary objectives are to determine whether it has any~     effects on outcomes and quality of life. As part of study participation patients will be~     asked to complete quality of life questionnaires as well as mini mental status~     questionnaires. These will be done prior to treatment and at follow up appointments~     throughout the next 3 years while participating in the study. Patients will be given the~     option to participate in the optional bio marker blood draw study which would require~     patients to have blood drawn at three time points, pre-treatment, the day after treatment and~     at their first follow up visit.~   "
131161|NCT01850550|"~     The specific objective of this research proposal is to determine the short-term efficacy of a~     primary care-based weight control intervention in which successful volunteer peers deliver a~     group-based program.~      The purpose of the study is to conduct a pilot randomized controlled trial (RCT) of a~     successful volunteer peer-led weight control program compared to a control condition to~     determine intervention efficacy at 3 months. Six peer leaders from 2 primary care clinics~     will be recruited and trained to conduct the intervention. Overweight and obese patients~     (n=80) will be recruited (randomized by individual) to determine weight loss at 3 months~     (primary outcome). The program consists of 12 weekly weight loss sessions led by a successful~     volunteer peer leader using an adaptation of the Diabetes Prevention Program to help~     participants lose weight.~   "
131162|NCT01850537|"~     This is a prospective, single-arm, open-label, non-randomized study. The aim of the study is~     to assess the safety and efficacy of the Prow LIF procedure in Transforaminal Lumbar~     Interbody Fusion (TLIF) procedures for the treatment of subjects with symptomatic~     degenerative disc disease (DDD).~   "
131168|NCT01850459|"~     The purpose of this research study is to establish a way to help the development of targeted~     treatments in autism spectrum disorders. This may also help in early diagnosis of autism and~     may possibly predict severity. The study will compare subject's ERK (extracellular~     signal-related kinase) signaling to age- and gender-matched neurotypical controls and~     Intelligence quotient (IQ)-matched developmental disabilities.~   "
131169|NCT01850446|"~     The purpose of this study is:~        -  to assess efficacy of Ergoferon for treatment of influenza;~        -  to assess safety of Ergoferon for treatment of influenza;~        -  to compare efficacy of Ergoferon and Oseltamivir for treatment of influenza.~   "
131170|NCT01850433|"~     The primary aim is to develop, and test the feasibility, of a novel and protocol-based~     cognitive behaviour therapy (CBT) treatment for body dysmorphic disorder (BDD) administered~     via the Internet.~   "
131171|NCT01850420|"~     This is a randomized, double-blind, placebo-controlled, 16-week study designed to evaluate~     the hypothesis that tissue-resident herpes virus may be causally related to fibromyalgia~     symptoms or recurrence. IMC-1 is a combination treatment that is designed to suppress this~     suspected virus and thus alleviate fibromyalgia symptoms.~   "
131172|NCT01850407|"~     Children are typically inadequately prepared for the sexual abuse medical examination.~     Caregivers report lack of examination knowledge as a barrier to preparing their children. The~     purpose of this study was to determine if informational leaflets provided prior to the~     examination are helpful to caregivers in preparing their children.~   "
131173|NCT01850394|"~     The purpose of this study is to determine 1) the effective dosage of intra-articular~     tranexamic acid injection for controlling blood loss and blood transfusion requirement in~     conventional total knee replacement, and 2) whether the blood loss reduction effect depended~     on the dose of tranexamic acid used.~   "
131174|NCT01850381|"~     GM608 is an endogenous human embryonic stage neural regulatory and signaling peptide that~     controls the development, monitoring and correction of the human nervous system. The study~     drug is an oligopeptide with a sequence identical to one of the active sites of human~     Motoneuronotrophic Factor and is manufactured by solid phase synthesis. Preclinical research~     indicates it to be a neuro-protective agent in animal models of PD, other neuro-degenerative~     diseases and stroke. This trial is designed to test proof of principle, i.e. determine if a~     2-week treatment with this agent can restore the non-functioning nigral dopaminergic neurons~     in PD over a 3 month period, during which the placebo-treated arm is expected to have little~     or no worsening of the total UPDRS (Unified Parkinson's Disease Rating Scale)score compared~     to baseline.~      Study Objectives are:~        1. To compare the safety and tolerability of GM608 with placebo in a population of patients~          with early PD.~        2. To field test the study procedures for feasibility and efficiency~        3. To determine if there is any hint that injections of GM608 might slow the rate of~          clinical worsening of PD.~   "
131175|NCT01850368|"~     Recently, several studies reported promising outcomes of patients after external beam~     radiotherapy (EBRT) for hepatocellular carcinoma (HCC) with portal vein tumor thrombosis.~     However, conventional EBRT is composed of many fractions (20-35 fractions). On the other~     hand, stereotactic ablative radiotherapy is a newly emerging treatment method to deliver a~     high dose of radiation to the target using a few fractions with a high precision within body.~     SABR increases radiation biologic effect for tumor, makes patients more comfortable due to~     reduction of the number of hospital visit, and enables patients to receive another treatment~     more quickly. This study will evaluate SABR effect with 40 Gy in 4 fractions for HCC with~     major portal vein tumor thrombosis.~   "
131176|NCT01850355|"~     The main objective of this exploratory 8-week pilot study is to evaluate the safety and~     efficacy of buspirone for the treatment of anxiety in youth (ages 6-17 years) with autism~     spectrum disorders. The study results will be used to generate hypothesis for a larger~     randomized controlled clinical trials with explicit hypotheses and sufficient statistical~     power.~   "
131177|NCT01850342|"~     Autologous washed and homogenized fat micrograft harvested from the patient's front abdominal~     wall enriched with adipose-derived regenerative cells (ADRC) derived by enzyme-treatment of a~     portion of the harvested fat. Fat tissue micrograft mixed with ADRC will be administered~     one-time endoscopically into submucosal layer of urethra under eye control. This is a single~     arm study with no control. All patients receive cell therapy.~   "
131178|NCT01850329|"~     This study is planning to develop the computed-assisted information program and determine~     whether the computed-assisted information program are superior to routine discussion for~     informing parents in the emergency department (ED) about risks, benefits, and alternatives to~     receiving procedural sedation for their children.~   "
131179|NCT01850316|"~     Respiratory-gated, volumetric-modulated arc therapy will be used for the clinical development~     of high dose rate Stereotactic Body Radiotherapy (SBRT) in inoperable hepatocellular~     carcinoma (HCC). These treatments should enhance local control, progression-free survival and~     potentially overall survival in HCC patients. The investigators will also examine the~     mechanism of tumour and microenvironmental response to high dose radiation, and search for~     potential biomarkers to optimize and individualize therapy. Pre-treatment and follow-up~     PET/CT imaging with 11C-choline, 18F-fluorodeoxyglucose (FDG) and CT perfusion will examine~     in-vivo changes in proliferation, glycolysis, and the tumour vasculature, respectively, and~     blood samples will look for immunologic biomarkers of tumour response.~   "
131201|NCT01850030|"~     Female inability to conceive a child. The purpose of this randomized, two-arm and double~     blind, double dummy study is to demonstrate that the treatment of a daily dose of 3x10mg~     dydrogesterone orally is as effective and safe as the daily dose of 3x200 mg micronized~     progesterone capsules administered intravaginally for the luteal support in patients~     undergoing IVF. The treatment will start on the day of oocyte retrieval and continue until~     pregnancy is negative or until week 12 gestation.Patients will be followed after treatment~     until 30 days after delivery to record any safety and tolerability data of the patient and~     their newborn(s).~   "
131202|NCT01850017|"~     The investigators will conduct a prospective randomized double blind study comparing~     methadone plus methadone and intraoperative dexmedetomidine in multi-level spine surgery in~     two randomized groups. The investigators plan to document the intraoperative opioid~     requirements, time to first dose of opioids postoperatively and total opioid consumption in~     the first 24, 48 and 72 hours. The incidence of intra and postoperative complications will be~     assessed.~   "
131180|NCT01850303|"~     For elderly patient, the treatment of Non Small Cell Lung Cancer was based on monotherapy but~     IFCT-0501 trial begun in 2006, demonstrated that a bitherapy (carboplatin and paclitaxel) is~     better than monotherapy in term of overall survival and progression free survival. The~     current recommendations are now to administer a carboplatin based bitherapy (4 or 6 cycles).~     After the treatment is stopped until progression and initiation of a second line treatment.~     The risk of this strategy is to be confronted to a rapid disease progression during the free~     interval. Indeed, about 1/3 of the patients whose disease was controlled after the~     chemotherapy do not receive 2nd line. The concept of maintenance is based on a continuous~     therapeutic pressure in order to preserve the therapeutic profit obtained by the treatment of~     1st line (induction chemotherapy).~      There is two types of maintenance :~        -  continuous maintenance therapy which consists in continuing the treatment initially~          associated with platinum until disease progression.~        -  switch maintenance which consists in introducing a new treatment after the end of~          induction chemotherapy The two types are validated by several trials. The marketing~          authorization of pemetrexed was enlarged to maintenance for non squamous carcinoma.~      Gemcitabine has a good tolerance profile which make possible the use in a maintenance~     strategy. Several trials evaluated maintenance with this product and some show benefits in~     term of progression free survival.~      The objective of this trial is to evaluate the switch maintenance in elderly patient with a~     controlled disease after 4 cycles of chemotherapy carboplatin-paclitaxel.~   "
131181|NCT01850290|"~     This study will examine resting dopamine function as well as dopamine response in the brain~     as it interacts with medicines normally prescribed to subacute Traumatic Brain Injury (TBI)~     patients.~   "
131182|NCT01850277|"~     The purpose of this prospective randomized study is to determine whether patients on cardiac~     resynchronization therapy with concomitant long-standing persistent or permanent atrial~     fibrillation would benefit from a strategy to restore and maintain sinus rhythm (rhythm~     control strategy) in comparison to a rate control strategy in terms of higher biventricular~     paced beats percentage.~   "
131183|NCT01850264|"~     Primary objective of this study is to evaluate whether the use of a quadripolar left~     ventricular (LV) electrode compared to a standard bipolar LV electrode leads to lower~     non-responder rates in patients undergoing cardiac resynchronization therapy (CRT)~   "
131184|NCT01850251|"~     The purpose of this study is to determine whether a nutritional supplement high in protein~     and energy, and enriched with hydroxymethylbutyrate (HMB) and vitamin D is more effective~     than a standard nutritional supplement high in protein and energy in improving muscle~     strength in elderly patients with hip fracture.~   "
131185|NCT01850238|"~     This first-time-in-man study is mainly designed to assess the safety and tolerability of~     AADvac1 in the treatment of Alzheimer's disease.~      AADvac1 is a vaccine directed against pathologically modified Alzheimer tau protein that is~     the main constituent of neurofibrillary tangles (NFTs), and is intended to be a~     disease-modifying treatment for Alzheimer's disease, i.e. to halt its progress.~      As this study is a Phase I study focused on tolerability and safety, efficacy will be~     assessed in an exploratory manner.~   "
131186|NCT01850225|"~     Current treatment options for bilateral profoundly deaf children, diagnosed with inner ear~     anatomical abnormalities are limited, and in the case of absent cochleas, non-existent. An~     auditory brainstem implant (ABI) places an electrode close to the auditory nucleus in the~     brainstem. Children aged 2 - 5 who are not candidates for a cochlear implant, or who did not~     demonstrate benefit from a cochlear implant, will be implanted with an ABI and followed for 1~     year for safety and a total of 3 years for preliminary efficacy. This is a feasibility study~     to determine the safety of the ABI.~   "
131187|NCT01850212|"~     A Phase 4 study is to characterize the profile of low bone mineral density (BMD) in ≥ 50 year~     old male subjects and post-menopausal female subjects on any tenofovir disoproxil fumarate~     (TDF)-based regimen~   "
131188|NCT01850199|"~     Gestational diabetes, diabetes diagnosed during pregnancy, affects 8.8% of pregnancies in~     Spain that means more than 40,000 women per year. This prevalence is based on the National~     Diabetes Data Group criteria, previous to the 4th workshop on Gestational Diabetes (1998),~     but, if the new diagnosis criteria proposed by the International Associations of Diabetes and~     Pregnancy Study Groups, based on the most important study never made before on this topic,~     prevalence would increase to the double. When a women is diagnosed, the risk of complications~     for her and the child increases and, therefore, she has to start an specific diet and~     frequent visits to the diabetes center in order to check that glucose values do not exceed 95~     mg/dl before or 140 mg/dl 1-hour after meals. In other case, she should start insulin~     treatment. Our project is aimed to develop intelligent tools based on neuro-diffuse~     techniques and integrated in a telemedicine system that allows control of gestational~     diabetes automatically, guaranteeing glucose control objectives consecution and avoiding~     face-to-face visits to the health care center. Furthermore, educational and motivation tools~     for a healthy behaviour will be included. At the end of the study efficacy and security about~     insulin management will be compare with the recommendations proposed by the diabetes team and~     data about direct and indirect costs will be calculated. The investigators anticipate that~     the smart telemedicine system can allow us to detect high blood glucose values earlier than~     in-person scheduled visits.~   "
131203|NCT01850004|"~     The study purpose is to test the hypothesis that Chronic Phase Chronic Myeloid Leukemia~     (CP-CML) patients with stable Complete Molecular Response (CMR) who discontinue Dasatinib~     treatment are able to maintain a sustained remission in the long-term, with undetectable or~     minimally detectable BCR-ABL residual disease.~   "
131204|NCT01849991|"~     This protocol is a study of the effects of Lactobacillus reuteri in 45 healthy infants with~     colic. The study is being conducted in order to prove treatment dose with probiotic~     (Lactobacillus reuteri) in a clinical setting is safe in healthy infants with colic.~   "
131205|NCT01849978|"~     This study will examine whether or not providing early stage breast cancer survivors with~     tips on making exercise more enjoyable promotes greater levels of moderate to strenuous~     exercise.~   "
131206|NCT01849965|"~     To determine if aclerastide (DSC127) is effective in increasing incidence of complete wound~     closure up to 10 weeks confirmed 2 weeks later, compared with vehicle (gel without active~     ingredient) and compared with a standard-of-care gel, in subjects with diabetes mellitus (DM)~     who have chronic Wagner Grade 1 or 2 diabetic foot ulcers, 0.75 - 6cm2 in size.~   "
131189|NCT01850186|"~     Recent data highlight the role of vascularity in melasma and a recent study showed the~     interest to target this vascular component by pulsed dye laser. The Dual Yellow laser is a~     copper bromide laser emitting dual wavelength (green 511nm and yellow 578 nm). This laser can~     target both the vascular and pigmented components of melasma. A preliminary study has shown~     its efficacy and excellent tolerability in the treatment of melasma. This study requires~     however to be confirmed by a comparative study versus reference treatment.~      Main objective To compare the efficacy on melasma at 6 month post treatment of a Dual Yellow~     Laser preceded by 1 month of kilnman trio and the kilnman trio monotherapy for 3 months in an~     intra-patient study.~      Secondary objectives~        -  To study the frequency of PPI.~        -  Compare the rate and extent of recurrence 6 months after completion of treatment.~        -  To study the occurrence of possible adverse effects.~        -  Compare the effectiveness of Dual Yellow laser to kilnman trio monotherapy at S12 (end~          of treatment).~        -  To study patient satisfaction on the effectiveness and tolerability of the study~          treatments.~      Methods Monocentric prospective interventional randomized split face comparative study~     between experimental treatment versus reference treatment.~      Intervention~        1. Visit Selection Patients will be selected from those presenting to the consultation of~          the department of dermatology at University Hospital of Nice. Participation will be~          offered to patients corresponding to the selection criteria of the study.~        2. Visit V0: Inclusion and early treatment After a minimum of 15 days, patients will begin~          the study. This will ensure that patients signed informed consent. An initial clinical~          evaluation of melasma with calculation of MASI score and standardized photographs (see~          chapter 'assessment') will be made. An examination by confocal microscopy in vivo will~          be realized. All patients will receive treatment by stabilized kilnman trio for four~          weeks.~           In the week prior to Visit 1, the side of the face to receive the laser treatment will~          be determined by randomisation.~        3. Visit V1: (Week 4) Clinical evaluation of melasma with calculation of MASI score and~          photographs will be made. Possible side effects (including PPI) will be noted.~           The next trio will be treated with depigmenting kilnman trio for another 8 weeks. The~          contralateral side will receive its first laser session. Given the results of analysis~          by intention to treat, the occurrence of serious side effects will result in~          discontinuation of treatment but monitoring will continue with the assessments.~        4. Visit V2: (week 6) Clinical evaluation of melasma with calculation of MASI score and~          photographs will be made. Possible side effects (including PPI) will be noted.~           The laser side will receive its second session. Patients continue the applications of~          cream on the contralateral side.~        5. Visit V3 (week 9) Clinical evaluation of melasma with calculation of MASI score and~          photographs will be made. Possible side effects (including PPI) will be noted.~           The laser side will receive its third session.Patients continue the applications of~          cream on the contralateral side.~        6. Visit V4 (week 12) Clinical evaluation of melasma with calculation of MASI score and~          photographs will be made. Possible side effects (including PPI) will be noted.~           The laser side will receive its fourth and final session. Patients continue the~          applications of cream on the contralateral side during 4 weeks.~        7. Visit V5: (week 18) Clinical evaluation of melasma with calculation of MASI score and~          photographs will be made. Possible side effects (including PPI) will be noted. An~          assessment by in vivo confocal laser will be realized.~        8. Visit V6: (week 24) Clinical evaluation of melasma with calculation of MASI score and~          photographs will be made. Possible side effects (including PPI) will be noted. An~          assessment by in vivo confocal laser will be realized.~        9. Visit V7 (final week 36):~      Clinical evaluation of melasma with calculation of MASI score and photographs will be made.~     Possible side effects (including PPI) will be noted. An assessment by in vivo confocal laser~     will be realized. The evaluation of safety and patient satisfaction will be performed using a~     visual analog scale.~      The primary endpoint will be the MASI score, score approved for assessment of melasma~     treatments.~   "
131190|NCT01850173|"~     The investigators designed the current study with the main objective of determining whether~     Whole Body Vibration Training (WBVT) alone improves muscular force and/or modifies the~     functional capacity parameters in severe Chronic Obstructive Pulmonary Disease (COPD)~     patients referred to a rehabilitation programme.~   "
131191|NCT01850160|"~     This trial is aimed to assess the efficacy and safety of a fixed-dose combination therapy~     with Valsartan and Chlorthalidone, Vs Valsartan or Chlorthalidone alone for treatment of~     adult patients with diagnosis of arterial hypertension.~   "
131192|NCT01850147|"~     The purpose of this study is to determine whether sequential application of low-dose~     short-term sunitinib and chemotherapy is effective in the treatment of non-small cell lung~     cancer after failure of conventional therapy. Safety of this regimen will also be evaluated.~   "
131193|NCT01850134|"~     The objective of this trial is to evaluate a nutritional supplement for people with Diabetes.~   "
131194|NCT01850121|"~     The aim of the study was to evaluate the efficacy of infliximab (IFX) treatment, 5 mg/kg~     every 6 weeks, in patients with active ankylosing spondylitis (AS) and to determine whether~     IFX dose reduction and interval extension, 3 mg/kg every 8 weeks during the second year~     sustained the treatment effect. The study was started in 2003 an finished in 2008.~   "
131195|NCT01850108|"~     Allogeneic blood or marrow transplantation (alloBMT) is a curative therapy for a variety of~     hematologic disorders, including sickle cell disease and thalassemia. Even when it is clear~     that alloBMT can give to these patients an improvement in their disease, myeloablative~     transplants have important toxicities and mortalities associated. The lack of suitable donors~     continues to be a limit to access to transplantation. Substantial progress has been made~     recently in the development of pre-treatment regimens that facilitate the sustained~     engraftment of donor marrow with reduced toxicity. Most of these regimens incorporate highly~     immunosuppressive drugs, which allow the reduction or elimination of myeloablative agents or~     total body irradiation without endangering the sustained engraftment of HLA-identical~     allogeneic stem cells. Preliminary results of non-myeloablative allogeneic stem cell~     transplantation suggest that the procedure can be performed in patients who are ineligible~     for myeloablative alloBMT, and that sustained remissions of several hematologic malignancies~     can be obtained.~   "
131196|NCT01850095|"~     Acne vulgaris is a chronic inflammatory disease that affects the pilosebaceous unit. Recent~     studies have demonstrated an increase number of acne cases in adult women. These cases are~     predominantly normoandrogenic and have some clinical differences when compared with the most~     common group, the adolescent. The local glandular metabolism converts some hormonal~     precursors to more active substances that increase the sebum production, leaving these areas~     more prone to increase the colonization to Propionibacterium Acnes (P. Acnes). Toll-like~     receptor 2, expressed by inflammatory cells play a crucial role in the innate immune response~     to this bacterium. Previous studies confirm that exist a reduced expression of CD1d by~     keratinocytes in acne lesion, what can be interpreted as a low antigen-present function. The~     influence of hormonal alteration in the sebaceous glands could modulate the expressions of~     TLR-2 and CD1d explaining the persistence of lesions in adult women. The change to more~     estrogenic metabolism, with use of specific contraceptive pills could normalize this~     immune-mediated inflammatory process.~      Objective~      To analyze how the peripheral androgen conversion can influence the toll-like receptor 2 and~     CD1d expression in women with inflammatory acne before and after 6 months of oral~     contraceptives with anti-androgen activity.~   "
131197|NCT01850082|"~     Coronary artery bypass grafting (CABG) is the most common major surgical procedure in the~     United States with over 300,000 cases performed each year. To restore blood flow to the~     heart, vascular conduits from another part of the body are procured to create a bypass around~     critically blocked coronary arteries. The left internal thoracic artery is the conduit of~     choice for CABG due to its superior long-term patency. However, almost all patients referred~     for CABG require additional grafts to provide complete revascularization. This necessitates~     the harvest of other vessels, most commonly the saphenous vein which is used almost~     ubiquitously in contemporary CABG with an average of two vein grafts per CABG procedure. In~     the last 10 years, Endoscopic Vein Harvesting (EVH) has been recommended as the preferred~     method over the traditional open harvesting technique (OVH) because it provides a minimally~     invasive approach. However, more recent investigations indicate potential for reduced~     long-term bypass graft patency and worse clinical outcomes with EVH. The long term impact of~     EVH on clinical outcomes has never been investigated on a large scale using a definitive,~     adequately powered, prospective Randomized Controlled Trial (RCT) with long-term follow-up.~   "
131198|NCT01850069|"~     The aim of this study is to determine whether we can predict the intracranial pressure using~     near infra-red spectroscopy~   "
131199|NCT01850056|"~     The purpose of this study is to determine whether DEB is more effective than common PTA~     balloon in long-term vessel patency and inhibiting restenosis.~   "
131207|NCT01849952|"~     MicroRNAs (miRNA) are molecular biomarkers that post-transcriptionally control target genes.~     Deregulated miRNA expression has been observed in diverse cancers. In high grade gliomas,~     known as glioblastomas, the investigators have identified an oncogenic miRNA, miRNA-10b~     (mir-10b) that is expressed at higher levels in glioblastomas than in normal brain tissue.~     This study tests the hypothesis that in primary glioma samples mir-10b expression patterns~     will serve as a prognostic and diagnostic marker. This study will also characterize the~     phenotypic and genotypic diversity of glioma subclasses. Furthermore, considering the~     critical function of anti-mir-10b in blocking established glioblastoma growth, the~     investigators will test in vitro the sensitivity of individual primary tumors to anti-mir-10b~     treatment. Tumor, blood and cerebrospinal fluid samples will be obtained from patients~     diagnosed with gliomas over a period of two years. These samples will be examined for mir-10b~     expression levels. Patient survival, as well as tumor grade and genotypic variations will be~     correlated to mir-10b expression levels.~   "
131208|NCT01849939|"~     Usually Chronic lymphocytic leukemia (CLL) is a disease of the elderly patients. However, the~     diagnosis in young patients become more frequently with poor prognosis. The identification of~     new prognostic factors permits early determination of the high risk population and provide~     them the therapeutic intensification. Allogeneic transplantation of hematopoietic stem cells~     transplantation (AHSCT) allows to long-term remission and in some cases complete and~     definitive eradication of the disease. After chemotherapy or antibodies, the Minimal Residual~     Disease (MRD) negativity is associated with better disease-free survival. MRD negativity~     occurs in some patients with the appearance of GVHD, stopping the immunosuppression or after~     donor lymphocyte injection (DLI). The negativity of MRD in the first year post-transplant is~     correlated with better progression-free survival or overall survival (Dreger 2010, Farina~     2009, Caballero 2005, Algrin, 2011). So, MRD negativity may be an objective after AHSCT. The~     aim of this prospective study is to evaluate a standardized preemptive immunointervention of~     post-allograft immunosuppressive therapy modulation and DLI administration according to MRD~     level. The objective is to obtain MRD negativity at 12 months after AHSCT.~   "
131209|NCT01849926|"~     Although uncomplicated cystitis is considered to be a mild condition and mostly self~     limiting, most patients who see a doctor will be treated with antibiotics. Antibiotics are~     known to give a quick relief of symptoms and shorten the course of the condition by a few~     days. The aim of this study is to evaluate ibuprofen versus mecillinam in the treatment of~     uncomplicated cystitis in otherwise healthy, non-pregnant women. Our main objective is to see~     whether symptomatic treatment with ibuprofen is equally efficient as treatment with~     mecillinam in this group.~   "
131210|NCT01849913|"~     The aim of the proposed study is to investigate the effects of low-level laser therapy on~     neck pain.~   "
131211|NCT01849900|"~     This study examines the efficacy of the Preconception Reproductive Knowledge Promotion~     (PREKNOP) intervention, designed to promote women's reproductive health and positive~     pregnancy outcomes. The study's goal is to educate low-income women about reproductive~     changes related to their menstrual cycle. The main hypothesis of the study is that women who~     receive the PREKNOP intervention will report reduced risk of unplanned pregnancy and~     increased reproductive knowledge, self-efficacy about that knowledge, and pregnancy planning~     ability.~   "
131212|NCT01849887|"~     Stroke is a major cause of adult disability. Currently approved reperfusion therapies are~     provided to only a small percentage of patients in the U.S. New therapies are needed that~     improve outcome and that can be accessed by a majority of patients. Animal studies suggest~     that bone marrow-derived mesenchymal stem cells, administered intravenously days after a~     stroke, safely improve long-term behavioral outcome. A large human experience suggests the~     safety of allogeneic bone marrow-derived mesenchymal stem cells. The current study aims to~     assess the safety of this therapy in patients with recent ischemic stroke.~   "
131213|NCT01849874|"~     The MILO Study (MEK Inhibitor in Low-grade Serous Ovarian Cancer) is a Phase 3 study during~     which patients with recurrent or persistent low-grade serous (LGS) carcinomas of the ovary,~     fallopian tube or primary peritoneum will receive either investigational study drug MEK162 or~     a chemotherapy chosen by the physician (liposomal doxorubicin, paclitaxel or topotecan).~     Patients will be followed to compare the effectiveness of the study drug to that of the~     selected chemotherapies. Patients may be eligible to crossover from physician's choice~     chemotherapy to MEK162 if they meet certain inclusion criteria including centrally confirmed~     disease progression. Approximately 360 patients from North America, Europe and Australia will~     be enrolled in this study.~   "
131214|NCT01849861|"~     The purpose of this study is to correlate in an elderly population (≥ 65 years), the~     different levels of serum TSH, with cardiopulmonary capacity, quality of life, depressive~     symptoms and cognition. And assess whether the increased serum TSH to the upper half of the~     normal range, through the use of antithyroid drugs, is associated with improvements in these~     parameters.~   "
131215|NCT01849848|"~     The purpose of this study is to determine the antitumor efficacy and safety of bendamustine~     (SyB L-0501: 90 mg/m^2/day) for a maximum of 6 cycles (1 cycle: intravenous administration~     for 2 consecutive days and 26-day observation period) in patients with relapsed/refractory~     multiple myeloma.~   "
131216|NCT01849835|"~     The purpose of this randomized controlled trial (RCT) is to compare the two ways (tras-rectal~     and trans-perineal) to perform prostate biopsy from the rate of Positive detection,~     complications, pain level, operation time and costs et al.~   "
131229|NCT01849666|"~     This open-label, multicenter, parallel study will evaluate the effect of multiple doses of~     vemurafenib on the pharmacokinetics of a single dose of phenprocoumon in patients with~     BRAFV600 mutation-positive metastatic malignancies. Patients will be randomized to receive~     either treatment A: a single oral dose of phenprocoumon 6 mg on Day 1 (Eligible patients will~     have the option to continue treatment with vemurafenib as part of an extension study~     (NCT01739764).), or treatment B: vemurafenib 960 mg orally twice daily on Days 1-29 plus a~     single oral dose of phenprocoumon 6 mg on Day 22 (with the option to receive vemurafenib in~     the extension study after completion of pharmacokinetic assessments).~   "
131813|NCT01842009|"~     The purpose of this study is to investigate the mean number of stimulation (high~     definition-transcranial direct current stimulation) sessions (up to 26) needed to achieve a~     clinical response with this response defined as a 50% decrease in Visual Analog Scale (VAS)~     for pain. These data will be important in defining the optimal number of sessions for future~     fibromyalgia subjects in Phase III trials.~   "
131217|NCT01849822|"~     This research study is being done to develop a brain controlled medical device, called a~     brain-machine interface or BMI, that will provide people with a spinal cord injury some~     ability to control an external device such as a computer cursor or robotic limb by using~     their thoughts.~      Developing a brain-machine interface (BMI) is very difficult and currently only limited~     technology exists in this area of neuroscience. The device in this study involves implanting~     very fine recording electrodes into areas of the brain that are known to create arm movement~     plans and provide hand grasping information. These movement and grasp plans would then~     normally be sent to other regions of the brain to execute the actual movements. By tying into~     those pathways and sending the movement plan signals to a computer instead, the investigators~     can translate the movement plans into actual movements by a computer cursor or robotic limb.~      The device being used in this study is called the NeuroPort Array and is surgically implanted~     in the brain. This device and the implantation procedure are experimental which means that it~     has not been approved by the Food and Drug Administration (FDA). One NeuroPort Array consists~     of a small grid of electrodes that will be implanted in brain tissue with a small cable that~     runs from the electrode grid to a small hourglass-shaped pedestal. This pedestal is designed~     to be attached to the skull and protrude though the scalp to allow for connection with the~     computer equipment.~      The investigators hope to learn how safe and effective the NeuroPort Array is in controlling~     computer generated images and real world objects, such as a robotic arm, using imagined~     movements of the arms and hands. To accomplish this goal, two NeuroPort Arrays will be used.~   "
131218|NCT01849809|"~     A research study of the effectiveness and safety of gamma knife ventral capsulotomy in~     patients with severe intractable obsessive-compulsive disorder (OCD).~   "
131219|NCT01849796|"~     A study to determine if transcranial direct current stimulation (tDCS, the device that~     regulates brain activity, can improve pain in people with neuropathic facial pain and compare~     which modality (inhibitory tDCS over the somatosensory cortex or excitatory tDCS over the~     motor cortex) can result in better pain-relief.)~   "
131220|NCT01849783|"~     This phase II trial investigates whether patients greater than or equal to 65 years of age~     diagnosed with myeloma or another plasma cell malignancy will have better outcomes with~     transplant followed by maintenance therapy, as primarily measured by progression-free~     survival, versus non-transplant approaches.~   "
131221|NCT01849770|"~     The purpose of this research is to find out if mexiletine is safe and effective in people~     with Amyotrophic Lateral Sclerosis (ALS). In this trial, participants will be taking either~     300 milligrams per day of mexiletine, 900 milligrams per day of mexiletine or placebo~     (non-active study drug). The safety and efficacy of these doses will be compared to see if~     one dose is better than the other.~   "
131222|NCT01849757|"~     The purpose of the study is to determine which priming fluid is the safest for use for~     priming the heart-lung machine used during cardiopulmonary bypass for patients undergoing~     cardiac surgery. The fluids to be compared are albumin and voluven. A control group will~     receive only crystalloid.~   "
131223|NCT01849744|"~     This is a Phase I, open-label, multicenter, dose-escalation trial of VS-4718, a focal~     adhesion kinase inhibitor, in subjects with metastatic non-hematologic malignancies. This~     clinical study is comprised of 2 parts: Part 1 (Dose Escalation) and Part 2 (Expansion). The~     purpose of this study is to evaluate the safety (including the recommended Phase II dose),~     pharmacokinetics (the amount of VS-4718 in your blood) and the anti-cancer activity of~     VS-4718. The pharmacodynamic effects (genes or proteins that may predict or show how your~     body may respond to VS-4718) will also be examined in tumor biopsies and blood samples.~   "
131224|NCT01849731|"~     The purpose of this cluster randomized trial is to determine whether an intervention~     implemented in a General Surgery, based in improving patient-provider communication, results~     in a better diabetes self-management in patients with lower educational level. A secondary~     objective is to assess whether telephone reinforcement enhances the effect of such~     intervention.~   "
131225|NCT01849718|"~     This research project deals with stress treatment in the form of garden therapy in the~     therapy garden Nacadia. The therapy Garden Nacadia has an evidence-based design that is~     specially designed for the treatment of stressed people.~      Nacadia-therapy can be described as a process in which the patient's health and well-being is~     assumed to enhance by the presence of the natural environment and through participating in~     meaningful gardening activities.~      NEST concerns research on the effect of Nacadia-therapy. The study consists of randomized and~     longitudinal studies of the effects of Nacadia-therapy compared to acknowledged cognitive~     behavioral therapy (CBT).~      The outcome measures for example consist of: ability to return to work, health care use,~     psychological measurements related to stress, health, quality of life and changes in~     medication use. Further, exploratory studies of the garden therapy in the form of~     observations and interviews will be performed, to get a better understanding of the garden~     and the garden activities' importance for the therapeutic purposes.~      Hypothesis:~      - garden therapy, in a designed natural environment, will lead to improved health and~     well-being for people who are off sick with stress-related disorders~   "
131226|NCT01849705|"~     Mutations in the melanocortin 4 receptor (MC4R) are the most common form of monogenic~     obesity, and can explain 2-6% of severe obesity.~      Studies have shown that mutations in MC4R are associated with increased fat mass,~     height-for-age, appetite and insulin resistance among children. In adults, mutations in MC4R~     are less penetrant for these phenotypes but it has been observed that individuals with MC4R~     mutations have a smaller than expected blood pressure for their degree of obesity.~      The purpose of this study is to explore the association between functional MC4R mutations and~     obesity, insulin resistance and blood pressure.~   "
131227|NCT01849692|"~     The purpose of this study is to demonstrate a treatment effect of ESBA1008 applied as a~     microvolume injection or infusion on retinal function and morphology in subjects with~     exudative age-related macular degeneration (AMD).~   "
131228|NCT01849679|"~     The investigators hypothesize that aspiration will be more prevalent at two to four hours~     post-extubation but will resolve in the majority of patients by 24 to 26 hours~     post-extubation.~      The purpose of the research is to investigate whether there is a difference in swallow~     function two to four hours after extubation (removal of breathing tube) compared to 24 hours~     after extubation. This information will help healthcare providers decide if it is necessary~     for people to wait 24 hours after extubation before they start eating and drinking.~   "
131230|NCT01849653|"~     To evaluate the agreement between NAAT results for Chlamydia trachomatis and Neisseria~     gonorrhoeae infection obtained with self-obtained vaginal swabs (SOVS), collected in a~     non-clinical setting vs. NAAT results using SOVS collected in a clinical setting. This is a~     new use of this specimen type as SOVS are FDA cleared only for use in clinics. The NAAT~     (Gen-Probe APTIMA Combo 2® Assay (AC2)) result with the home-collected SOVS specimen will be~     compared to the result obtained with an SOVS collected in the clinic on multiple platforms~     (Direct Tube Sampling (DTS) / Panther / Tigris). The term home-collected is used to refer~     to any specimen that is not collected in a clinic, since there is no certainty that a~     specimen is collected at home or in a restroom in an office setting, etc. To compare the~     SOVS results to an FDA cleared predicate test with the collection of two clinician collected~     vaginal swabs.~   "
131231|NCT01849640|"~     This is a two-arm, open label Treatment Study comparing the efficacy, safety, tolerability~     and pharmacokinetics of a three-day course of Dihydroartemisinin-Piperaquine (DP) with or~     without single-dose primaquine in patients with uncomplicated Plasmodium falciparum malaria.~     On the last day of DP therapy, volunteers will be randomized to receive either a single 45 mg~     dose of primaquine (PQ) or DP treatment only (no primaquine).~   "
131232|NCT01849627|"~     A study to investigate the effect of a low-ED prescription (consume ≥10 foods ≤ 1.0 kcal/g~     and ≤ 2 foods ≥ 3.0 kcal/g per day) versus an energy balance prescription (consume a daily~     energy intake at estimated energy needs for maintenance) on weight loss maintenance.~   "
131233|NCT01849614|"~     The purpose of this research study is to demonstrate that Deep Inspiration Breath Hold~     (DIBH), the technique used at the University of North Carolina (UNC) for left-side breast~     cancer radiation therapy, can reduce side effects to the heart.~   "
131234|NCT01849601|"~     The purpose of this study is to determine whether the peripheral balloon dilatation catheter~     (trade name: Iris) is safe an effective in PTA procedure.~   "
131235|NCT01849588|"~     This research study is a Phase IV clinical trial. Phase IV trials are used to further test~     and monitor the safety of a drug approved by the FDA and to see if the drug has any other~     indications that can be used to treat different diseases.~      Sorafenib is a new drug, which is approved under the brand name Nexavar for the treatment of~     liver cancer. It is also currently being tested in various other cancers. Sorafenib works by~     slowing down and/or stopping the development of new cancer cells and new blood vessels. By~     slowing down and/or stopping the growth of new blood vessels around a tumor, it is believed~     that sorafenib prevents or slows down the growth of tumors.~      The researchers of this study would like to study the effects of sorafenib on hepatitis C by~     drawing additional research blood samples from people infected with hepatitis C who are~     receiving sorafenib treatment for liver cancer. These tests will measure certain proteins in~     the blood (HCV-RNA) which may indicate if sorafenib has any effect on the hepatitis C virus.~   "
131236|NCT01849575|"~     This population based randomized controlled trial (RCT) aims at optimizing cardiovascular~     disease (CVD) prevention through accurate identification of individuals at high risk of CVD~     and accurate perception of the risk, and better compliance to preventive treatments and~     reduced premature CV morbidity and mortality Increased carotid artery intima-media thickness~     (CIMT) and carotid plaques, assessed by ultrasonography, are early signs of atherosclerosis~     and associated with myocardial infarction and stroke. Few studies have systematically~     evaluated image-based risk stratification and its effect on clinical outcomes and results are~     conflicting.~      The Västerbotten Intervention Programme (VIP), Northern Sweden, is integrated in primary care~     services with assessment of traditional CV risk factors and individual health promoting~     counseling for all 40-, 50- and 60-year olds (n=6500/yr). Those with diabetes, hypertension,~     family history of premature CVD and/or hypercholesterolemia are referred to treatment.~      VIP participants with at least one conventional CV risk factor (60% of participants) are~     eligible for inclusion in VIPVIZA. During 2013-2015, 3200 participants will be enrolled.~     Portable carotid ultrasound machines will be used for ultrasound examinations, whereby CIMT~     and plaque formation will be visualized and measured.~      Subjects will be randomly assigned to one of two groups; 1/ Intervention: Written information~     to patient and physician, including graphic presentation in color of CIMT and of plaque,~     vascular age, an ultrasound image, general information about atherosclerosis as a dynamic~     process, and recommendation to follow clinical guidelines for risk factor control. 2/~     Control: No information from the baseline ultrasonography.~      We will explore determinants of behavioral change using psychometric questionnaires and level~     of health literacy. Deep interviews at the time point for the ultrasound examinations will~     explore how the screening relates to risk perception, quality of life, coping strategies,~     attitudes to and skills of self-care.~      Both groups will be managed according to clinical guidelines within the usual health care.~     After three years (2015-2017), the ultrasonography is repeated and information given to all~     participants and their physicians.~      CV risk factors, life style and pharmacological treatments will be assessed after one and~     three years. CV morbidity and mortality and all-cause mortality will be followed during five~     years, i.e. until 2020.~   "
131237|NCT01849562|"~     The purpose of this study is to evaluate the safety, tolerability and efficacy of 12 weeks of~     treatment with sovaprevir, ACH-0143102 and ribavirin in GT1, treatment-naive, HCV subjects.~   "
131238|NCT01849549|"~     Two groups of subjects will be constitute: (i) patients with circumscribed brain injury~     (including stroke, vascular malformations, tumor or circumscribed infectious lesions) or~     degenerative disorders and selective cognitive disorders; (ii) healthy control subjects.~      The objective of this project is to evaluate specific neuropsychological deficits and apply~     current brain imaging techniques (anatomical, diffusion, functional) to patients suffering~     from these cognitive deficits due to brain damage, in order to elucidate the brain mechanisms~     underlying these deficits.~   "
131239|NCT01849536|"~     Ocular hypertension and its fluctuations is a major risk factor of glaucoma onset and~     progression. In normal eyes, IOP presents a circadian rhythm, but in glaucomatous eyes IOP~     circadian rhythm is altered and varied widely between patients. To date, the only way to~     evaluate 24 hour IOP fluctuations is a regular GAT-IOP measurement during a 24-hour~     hospitalization. This method is expensive and does not reflect physiological conditions~     because it requires IOP measurements during sleeping periods that may potentially produce~     artifacts.~      Sensimed AG has developed a new medical device SENSIMED Triggerfish® that enables a 24-hour~     continuous monitoring of IOP fluctuations. As any IOP measurements methods, this medical~     device might be influenced by corneal properties of the cornea as central corneal thickness,~     keratometry or biomechanics. We, therefore, investigate the corneal lens tolerance, potential~     modifications of corneal parameters after a 24-hour wear of the lens, and its influence on~     data collected during the whole period of analysis. Then we will also analyze the influence~     of corneal parameters on continuous IOP fluctuations measured with the contact sensor and~     finally the correlation between data collected and the rate of progression (severity) of~     glaucoma evaluated with visual field test or optic nerve head damages.~   "
131240|NCT01849523|"~     Background Physical as well as psychosocial complaints are frequently present in patients~     with a neuroendocrine tumor (NET). Adequate information is seen as an essential aspect of~     supportive care. The aim of the current study is to test the effectiveness of a web-based~     tailored information and support system targeting patients' information and care needs. Key~     features of this system are self-screening of physical and psychosocial problems, tailored~     education on reported problems and self-referral to professional health care.~      Objective To detect whether a web-based tailored information and support system improves~     patients' perception and satisfaction of received information. The investigators hypothesize~     that after having received web-based tailored information and support patients feel more~     informed and are more satisfied with the received information than when receiving standard~     care.~      Study design The present study is a randomized prospective longitudinal experimental~     multicenter pilot study. In this study, we want to examine the effect sizes on the perception~     and satisfaction by the patient of received information (primary objective) and secondary~     objectives after having used web-based tailored information and support. Eligible are newly~     diagnosed NET-patients (N=40) (diagnosed less than 3 months ago). Patients will be asked to~     fill out questionnaires at baseline and after 12 weeks, on socio-demographic features (only~     at baseline), internet use (only at baseline), health care use, patients' perception and~     satisfaction of received information, distress, quality of life and empowerment (only after~     12 weeks).~      Study population Patients diagnosed with a NET (any type of NET, any phase of disease) who~     are under treatment at the Department of Medical Oncology in the University Medical Center~     Groningen or Hospital Medisch Spectrum; twenty will be invited to participate in the study.~      Intervention During 12 subsequent weeks, a personalized website (with a surname/password)~     will become available to patients in the experimental group beside the usual standard care.~     Key features of the website are self-screening, tailored patient education and self-referral.~     Self-screening will be performed by an online version of the Dutch Distress thermometer (DT)~     and Problem List (PL). Patients will receive automated feedback on their DT score immediately~     after test completion together with information regarding problems reported on the PL,~     options for (self)-help and possibilities for referral to professional care. Contact~     information will also be available to discuss questions, problems and/or referral needs.~     Patients may also request a telephone call.~      Main study endpoint The primary endpoint is to detect an improvement in patients' perception~     and satisfaction of received information after having received web-based tailored information~     and support.~   "
131241|NCT01849510|"~     Spinal metastases indicate for an incurable course of disease. Local tumor control after~     palliative radiotherapy of spinal metastases (10x3 Gy, 1x8Gy) is between 61 to 81%. In 30% of~     patients, therapy fails locally within two years associated with further symptoms that are~     difficult to treat, because a further radiation of already radiated vertebra leads to a~     higher rate of myelitis. This trial aims to improve local tumor control and control of pain~     by radiotherapy with increase in total and single dose. Dose elevation is realized by~     simultaneous, integrated boost mediated by image-guided stereotactic radiotherapy (IGRT &~     hfSRT) and by elevation of elective dose in vertebral body with 12x3 Gy (standard: 10x3 Gy).~     Primary endpoint is local tumor control (time up to progression). Secondary endpoints are~     pain control associated with quality of live, severity of acute and chronic adverse effects~     and overall survival. It is planned to recruit a total number of 155 patients.~   "
131242|NCT01849497|"~     The primary objective of this study was to assess users' ability to administer a full dose of~     evolocumab in home-use using either a pre-filled syringe or autoinjector/pen.~   "
131243|NCT01849484|"~     This randomized trial examines possible enhancements in live quality and neurocognitive~     functions in patients after radiotherapy of the neurocranial area with hippocampal sparing.~     Although the hippocampus has a crucial role in regard to neurocognition and memory,~     hippocampal region has been relatively disregarded in radiotherapy of neurocranium so far.~     Brain metastases in the hippocampal region are very rare and an infiltration of the~     hippocampus by meningioma or by pituitary adenoma just occurs when volume of the tumor is~     very high. This study aims to reduce the radiation dose in the hippocampal region to improve~     the quality of live and neurocognitive functions in patients without degrading prognosis or~     increasing probability of brain metastases in hippocampal region.~      Primary endpoint of the trial is quality of live and neurocognitive functions in patients~     after radiation of neurocranial region with hippocampal sparing compared with conventional~     radiotherapy of the neurocranial region without hippocampal sparing. Secondary endpoints are~     cerebral recurrence rate in hippocampal region and overall survival. It is planned to include~     a total number of 150 patients.~   "
131244|NCT01849471|"~     This trial is an interrogation of patients with prostate cancer to evaluate socioeconomic~     effects of radiotherapy. Patients with percutaneous or interstitial or combined percutaneous~     and interstitial radiotherapy are included. Beside medical effects and adverse events, it's~     prospectively needed to extensively inform patients about socioeconomic aspects associated~     with radiotherapy. The interrogation comprises to collect possible costs and expenditures~     during and after therapy. Aspects especially concerning post therapy period include~     additional consultations, individual applied alternative medical care, need for additional~     medical aids (salves, medicine, bandages) and changes in professional and social situation.~     It's figured out in what extend costs are absorbed by health insurance coverage. In Germany~     there is no appropriate trial with respective patient population and respective therapy.~     Primary endpoint is the evaluation of therapy concerning and follow-up costs as well as~     changes in social and professional situation. Secondary endpoints are quality of life,~     adverse events of therapy and the correlation of quality of life, adverse events and economic~     aspects for the patient and the health insurance coverage.~   "
131245|NCT01849458|"~     The aim of this study is to collect and report data from a consecutive series of patients~     implanted with these products as part of a post-market surveillance plan for CE Mark approval~     in the European Union.~   "
131246|NCT01849445|"~     The TRIO-physio study is looking at how well patients with osteoarthritis recover after knee~     replacement surgery (also known as Total Knee Arthroplasty (TKA)). Currently around 20% of~     patients are not satisfied after TKA. This project will look to find out if the research team~     can identify patients who will not recover well at an earlier stage, so that these patients~     can be helped sooner.~      The study will try to determine if doing intense physiotherapy with patients who are not~     doing well at the first review (6 weeks after their operation) can improve how well they have~     recovered at one year.~   "
131247|NCT01849432|"~     A diverse body of research has implicated the amygdalo-cortical circuitry in the~     pathophysiology of anxiety disorders. For example, one model of PTSD posits exaggerated~     amygdala responsivity to threat-related stimuli as well as deficient top-down modulation of~     amygdala responses by specific cortical regions, including the pregenual anterior cingulate~     cortex, subcallosal cortex, and hippocampus.~      The investigators propose to investigate the pathophysiology of several specific anxiety~     disorders, Posttraumatic Stress Disorder (PTSD), Panic Disorder (PD), and Specific~     Phobia(SP), by using cognitive activation paradigms and magnetic resonance imaging (MRI) to~     probe the function and structure of implicated amygdalo-cortical circuitry.~   "
131283|NCT01848964|"~     This study aims at evaluating the relation between quality of the interface between the stump~     and the prosthesis, and the quality of gait in above-knee amputees.~      The hypothesis is that an adapted prosthesis allowing an efficient gait in above-knee~     amputees corresponds to an homogeneous pressure distribution pattern onto the stump.~   "
131248|NCT01849419|"~     The main aim of the study is to investigate the effects of ±3,4-methylenedioxymethamphetamine~     (MDMA; ecstasy) on social and emotional processing in healthy humans. Ecstasy is a widely~     used recreational drug, with over 2 million Americans reporting use of the drug in 2006. With~     this number of users, and evidence that high doses of MDMA are neurotoxic in laboratory~     animals, the public health implications of ecstasy use may be substantial. Certain subjective~     effects of this drug distinguish it from other stimulants, and may contribute to its~     widespread use: That is, users report that ecstasy produces profound feelings of empathy and~     closeness to others. These so-called 'empathogenic' effects, which may reflect the~     distinctive neurochemical profile of action of the drug, have yet to be characterized in~     controlled laboratory studies. The investigators propose to characterize the effects of MDMA~     on measures of social and emotional processing that may contribute to this 'empathogenic'~     profile, including measures of emotion recognition, emotional responsiveness and sociability.~     The investigators will assess effects of MDMA (0, 0.75 and 1.5 mg/kg up to 125 mg) one active~     control drug (oxytocin: 20 IU) in 100 volunteers who report some prior ecstasy use. Oxytocin~     will be used because it appears to produce pro-social behavioral effects resembling those~     attributed to MDMA.~   "
131249|NCT01849406|"~     It is anecdotally well known that patients snore more when their nose is blocked. However,~     the therapeutic effect of improving nasal airway patency on snoring indices remains a point~     of conjecture. Indeed, Braver et al examined the effect of a nasal vasoconstrictor and failed~     to show any improvement in the number of snores after its application, although~     apnoea-hypopnoea index (AHI)seemed to decrease. Furthermore, Hoffstein et al documented that~     dilation of the anterior nares in patients without nasal pathology has a relatively weak~     effect on snoring, and routine use of nasal dilating appliances was not recommended for the~     treatment of snoring. In contrast to the aforementioned studies, intranasal corticosteroids~     have been shown to improve sleepiness and reduce AHI in patients with obstructive sleep apnea~     (OSA) implying that there might be an equivalent result for the use of nasal steroids on~     snoring indices.~      Additionally, the present authors have demonstrated a strong correlation between~     apnoea-hypopnoea index and oral/oro-nasal breathing epochs in patients with OSA and normal~     nasal resistance and that nasal surgery is effective only in OSA patients who preoperatively~     have decreased nasal breathing epochs.~      It is plausible thus to suggest that snoring severity, in equivalence to OSA severity, might~     be associated to oral/oro-nasal breathing epochs and that improving nasal patency by nasal~     steroids might also increase nasal breathing epochs and lead to decreased snoring indices in~     patients who had decreased nasal breathing before the administration of nasal steroids.~      Patients will be randomized in two groups: the patients of the first group will undergo a one~     week therapy of nasal budesonide, then two weeks of washout period, and thereafter one week~     of nasal normal saline. The patients of the second group will undergo a one week therapy of~     nasal normal saline, then two weeks of washout period, and thereafter one week of nasal~     budesonide. Before and after each treatment regimen patients will undergo an assessment,~     which will consist of anterior rhinomanometry and polysomnography with concomitant~     measurement of snoring indices and breathing route pattern.~      The investigators hypothesize that the application for one week of nasal budesonide has a~     beneficial effect on snoring indices in patients who present before the application decreased~     proportion of nasal breathing epochs and in whom nasal budesonide succeeded in increasing~     nasal breathing epochs.~   "
131250|NCT01849393|"~     The primary objective of this project is to assess the study population's acceptance of two~     medication adherence support strategies: incentive-based programs and electronic medication~     monitoring. The study population is adolescents (ages 16 - 24) positive for human~     immunodeficiency virus (HIV) currently undergoing treatment with antiretrovirals at St.~     Jude's HIV clinic. Participation in the study will involve completion of a survey: an Audio~     Computer Assisted Self Interview (ACASI). The duration of the survey is anticipated to be~     10-20 minutes. Patient identifiers will not be attached the survey.~   "
131251|NCT01849380|"~     S-1 is a newly developed novel oral dihydrouracil dehydrogenase inhibiting fluoro-pyrimidine~     drug consisting of i M tegafur (FT), 0.4 M 5-chloro-2, 4-dihydroxypyrimidine (gimeracil), and~     1 M potassium oxonate (oteracil), with efficient antitumor activity and low gastrointestinal~     toxicity. Several studies have proved the safety and efficacy of single agent S-1 in~     metastatic breast cancer. This study is designed to further investigate and compare the~     efficacy and safety of Epirubicin-cyclophosphamide-S-1(ECS) vs.~     Epirubicin-cyclophosphamide-5-fluorouracil (ECF) as neoadjuvant chemotherapy in patients with~     local advanced breast cancer.~   "
131252|NCT01849367|"~     Transcranial direct current stimulation (tDCS) is a novel treatment approach for depression~     that has shown promising efficacy in four recent double-blind, randomized, sham-controlled~     trials (RCT) and a meta-analysis. Mood, cognitive test performance and biomarkers will be~     measured during the trial.~   "
131253|NCT01849354|"~     The women's clinic at Turku University Hospital has also since year 2000 accomplished and~     systematically increased advanced surgical treatment for the endometriosis patients with~     difficult disease. The aim is to centralize endometriosis treatment in the hospital district~     and by doing that be able to offer exact diagnosis, advanced surgical treatment and~     infertility treatment for every patient in the hospital area. The main purpose of this study~     is to find out how the operative treatment of endometriosis patients in Turku University~     Hospital is functioning and to see how the quality of life of these patients is before and~     after the surgery. Furthermore, the structure of the endometriosis patients' endometrium and~     the different markers of blood and urine are studied.~   "
131254|NCT01849341|"~     It is a phase IV clinical trial: longitudinal, prospective, evaluator-blind, randomized into~     2 groups of patients with chronic obstructive pulmonary disease (COPD). The intervention~     group was based on the administration of roflumilast 500 mcg per day on alternate days~     (roflumilast 500μg eod) for 2 weeks (phasing). In the control group assigned to undertake the~     treatment according to the standard dosage (roflumilast 500μg od).~      The patient monitoring will be done by one of the sub-investigators fully independent team~     that started the medication keeping the pattern masking by single blind, and since it aims to~     assess the frequency of adverse events (AEs) in both groups were collected systematically~     different AEs and their characteristics at 15 days (V1), and from that moment a month (V2)~     and 2 months (V3). Likewise, other data collected (functional demographic, comorbidities,~     home treatment, anxiety and depression and quality of life).~      The purpose of this study is to assess whether the administration of roflumilast by a gradual~     pattern varies the incidence of discontinuations due to adverse events when compared with the~     usual dosage.~   "
131255|NCT01849328|"~     Volatile Organic Compounds (VOC) in human breath are captured and analyzed by the~     Spectrosense EVA system, which is combination of a gas chromatography (GC) and software~     algorithm. The objective is to obtain a set or sets of VOC bio-markers that will provide the~     best discrimination between Breast Cancer sick population and healthy population. The gold~     standard for identifying sick/healthy population is biopsy proven breast cancer.~   "
131719|NCT01843244|"~     Data from both the traditional invasive cardiac monitors and the Nonin will be collected~     simultaneously. The investigators will analyze Nonin data for peak and trough variation with~     respiration, area under the curve, time from trough to peak, and slope, and compare these to~     data collected from the invasive monitors to look for correlations in clinically important~     parameters such as blood pressure, central venous pressure, cardiac output, etc.~   "
131256|NCT01849315|"~     Obesity is associated with increased risk of heart disease and diabetes (Kim et al., 2010).~     Appalachian children in Athens County, Ohio, experience higher rates of obesity compared to~     the national average (20.9% vs. 15.4%), which increases their risk of obesity-related~     diseases (Montgomery-Reagan, Bianco, Heh, Rettos, & Huston, 2009). Although physical activity~     (PA) is known to improve fitness and adiposity (Gutin & Owens, 2011; Yin et al., 2009), very~     little is known about the effects of PA on the progression of chronic disease risk factors~     (biomarkers) for obesity-related diseases in children, such as inflammatory markers, lipids,~     and glucose/insulin. This lack of knowledge is due to a limited understanding of the number~     of calories burned during children's free-play PA. This study will assess the impact of a PA~     program (ACT) of known energy cost on obesity-related disease markers in 2nd-4th grade~     children compared to a sedentary control group (SED). The study will recruit children from an~     after-school program in Athens County elementary schools. Baseline and posttest data will~     include measures of height, weight, body composition, blood pressure, and physical activity~     levels. Following baseline measures, children will be randomized into either the ACT or SED~     group for 8 weeks. The ACT group will play recess-type games previously determined to expend~     ≥100 calories in 30 minutes. The SED group children will play sedentary-type activities~     during the same time period. It is hypothesized that the ACT group children will demonstrate~     significant improvements in PA after 8 weeks compared to the SED group children and that~     these improvements will be related to positive changes in body weight and body composition.~   "
131257|NCT01849302|"~     Over the last decades, changes in the diet and lifestyle have led to overall energy imbalance~     becoming commonplace and the emergence of an obesity epidemic with more than 1.6 billion~     adults being overweight.~      Consumption of foods that can affect appetite by increasing satiety could regulate the total~     energy intake and thus body weight. There is data suggesting that the macronutrient~     composition of the foods and especially protein content may have a potent role on satiety.~     However, it is difficult to pinpoint the optimum quantity needed to observe significant~     effects of protein on satiety.~      The research project is dedicated to identify which food components [proteins, carbohydrates~     (CHO), fats] and the optimized protein quantity needed to accelerate satiation, suppress~     appetite and extend satiety until hunger appears again.~      It is hypothesized that the consumption of protein-enriched meals will induce a reduction in~     hunger through the impact on gut hormones and peptides that are closely related to the~     short-term regulation of food intake.~   "
131258|NCT01849289|"~     This trial was conducted in Africa, Asia, Europe, North and South America. The aim of the~     trial was to compare efficacy and safety of insulin degludec and insulin glargine in insulin~     naïve subjects with type 2 diabetes.~   "
131259|NCT01849276|"~     The purpose of the study is to determine if metformin in combination with cytarabine is safe~     and effective. Participants in this research study have acute myeloid leukemia (AML) that has~     come back after initial treatment or has not gone away with initial therapy.There is evidence~     that metformin directly kills leukemia cells. Laboratory data have also shown that~     combinations of metformin with cytarabine are more efficient than each agent alone in killing~     leukemia cells in the laboratory.~   "
131260|NCT01849263|"~     This phase II trial studies how well ibrutinib works in treating patients with follicular~     lymphoma that has come back after a period of improvement or does not respond to treatment.~     Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell~     growth.~   "
131261|NCT01849250|"~     This randomized phase II trial studies how well docosahexaenoic acid works in preventing~     recurrence in breast cancer survivors. Docosahexaenoic acid supplement may prevent recurrence~     in breast cancer survivors.~   "
131262|NCT01849237|"~     Septic shock remains a significant clinical problem associated with high rates of mortality~     among neutropenic patient despite antimicrobial therapy and supportive care. Recently,~     mesenchymal stromal cells (MSC) have demonstrated remarkable potential effect in sepsis. MSC~     treatment significantly reduced mortality in septic mice receiving appropriate antimicrobial~     therapy. MSCs reduced systemic inflammatory cytokine levels in mice, down-regulated of~     inflammation and inflammation-related genes (such as interleukin-10, interleukin-6).~     Bacterial clearance was greater in MSC-treated mice. Thus, MSCs have beneficial effects on~     experimental sepsis and suggest that MSСs-therapy may be an effective adjunctive treatment to~     reduce sepsis-related mortality.~      The safety of MSCs is proved by Graft-versus-host disease treatment MSCs in patients after~     bone marrow transplantation.~      This study hypothesis is that MSCs reduce organ dysfunction/injury, systemic inflammation and~     mortality in patients with septic shock and severe neutropenia.~      The main goal of the study is to evaluate the impact of MSCs therapy on organ~     dysfunction/injury, systemic inflammation and 28-day mortality in patients with septic shock~     and severe neutropenia. All patients will be randomized in two groups: control group~     (standard treatment of septic shock) and MSCs-group (standard treatment of septic shock +~     MSCs infusion of 1-2 millions/kg/ day).~   "
131263|NCT01849224|"~     The primary outcome is the change in lower extremity edema-related symptoms. Secondary~     outcomes include the compliance rate of management guidelines for lower extremity edema, the~     performance rate for pelvic and lower extremity exercise.~   "
131264|NCT01849211|"~     Difficult mask ventilation might lead to a life-threatening situation, if endotracheal~     intubation is also impossible and neuromuscular blocking agents (NMBA) inhibit spontaneous~     ventilation. However, controversies exist if NMBA improve or impede face mask ventilation.~     Therefore, the effect of NMBAs on mask ventilation is assessed in patients with predictors~     for difficult face mask ventilation.~   "
131265|NCT01849198|"~     Accelerometric Assessment of neuromuscular block during anaesthesia is routinely performed at~     the M. adductor pollicis. However, many operations require positioning of the patients with~     arms attached to the body. In these situations, the anaesthesiologist has no access to the~     m.adductor pollicis.~      In this study, a new position of accelerometry at the neck is evaluated: Stimulation of the~     n. accessorius with accelerometry of the m. trapezius.~   "
131266|NCT01849185|"~     The primary objective is to examine whether probiotics given to hypercholesterolemic patients~     treated with statins, would further decrease LDL-Cholesterol levels.~      The secondary objective is to examine whether adding of probiotics to statins would decrease~     fasting glucose levels and glycolysated hemoglobin~   "
131267|NCT01849172|"~     The primary object is to evaluate the efficacy and safety of electroacupuncture for symptoms~     of menopausal transition .~   "
131268|NCT01849159|"~     Actively developing stem cells (SCs) transplantation techniques cause natural interest to the~     problem of regeneration in the lungs. Numerous experimental studies proved the benefits of~     different types of SCs in experimental models of pulmonary emphysema (PE).~      G. Zhen et al. have shown that the transplantation of mesenchymal stem cells (MSCs) to rats~     with papain-induced emphysema leads to their migration into the lungs, differentiation into~     type 2 alveolocytes, and inhibition of apoptosis and prevention PE.~      K. Schweitzer et al. have proved the activity of inflammation in the airways, alveolocytes~     and endothelial cells apoptosis decreased after adipose SCs intravenous administration to~     mice with emphysema caused by chronic exposure to tobacco smoke or VEGF receptors blockade.~     The study of E.P. Ingenito et al. found that endobronchial installed MSCs engraft into the~     alveolar wall and peribronchial interstitium and release integrins, extracellular matrix~     components (collagen IV, laminin and fibrillin), platelet-derived growth factor receptor and~     transforming growth factor β2.~      Our study also found reliable deterrent effect of allogeneic bone marrow MSCs on the~     development of elastase-induced emphysema in rats at different terms of transplantation.~      After the success of pilot studies have started clinical trials. Currently, the website~     http://www. ClinicalTrials.gov reported three studies evaluating the efficacy and safety of~     MSC transplantation in patients with COPD and emphysema. Two of them have already been~     completed and the results of the first pilot project published.~      Authors on the example of 4 patients showed a complete absence of adverse effects, improved~     quality of life and stability of functional parameters at 12 months after starting treatment~     One of the problems of MSC transplantation in patients with respiratory failure is an~     accelerated apoptosis of transplanted cells under the influence of proinflammatory cytokines~     and oxidative stress. Since it is proved that preconditioning MSCs under hypoxia increases~     their survival in hypoxic conditions, increases the expression of growth factors and~     antiinflammatory cytokines, we suppose that MSCs grown in hypoxic medium may have a~     significant positive effect on the disease.~   "
131269|NCT01849146|"~     This phase I trial studies the side effects and best dose of adavosertib when given together~     with radiation therapy and temozolomide in treating patients with newly diagnosed or~     glioblastoma that has come back. Adavosertib may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth. Radiation therapy uses high energy x rays to kill~     tumor cells and shrink tumors. Drugs used in chemotherapy, such as temozolomide, work in~     different ways to stop the growth of tumor cells, either by killing the cells, by stopping~     them from dividing, or by stopping them from spreading. Giving adavosertib, radiation~     therapy, and temozolomide may work better in treating patients with newly diagnosed or~     recurrent glioblastoma.~   "
131270|NCT01849133|"~     The purpose of this study is to investigate the efficacy of exclusive intraoperative~     radiation therapy after conserving surgery in early-stage breast cancer compared with whole~     breast radiotherapy. The primary outcome was the rate of ipsilateral true recurrence ( any~     recurrence at or close to primary tumor bed) and new ipsilateral tumors ( any recurrence~     occurring in quadrants other than the previous one) and the recurrence free survival.~   "
131271|NCT01849120|"~     Neonates and infants that have cardiac surgery with cardiopulmonary bypass (CPB) for~     congenital heart disease are at great risk for experiencing life-threatening low cardiac~     output syndrome (LCOS) in the first 24 hours after surgery. The poor perfusion and inadequate~     oxygen delivery that occurs may result in multiple organ failure and death. It is LCOS that~     is responsible for the majority of early postoperative deaths in this population of neonates~     and infants. Improved pediatric probes placed in peripheral locations using near infrared~     spectroscopy (NIRS) may permit continuous monitoring of venous saturations reflecting overall~     perfusion and oxygen balance in the tissues. Following parental or guardian consent, 30~     neonates and infants scheduled to undergo surgery for congenital heart disease will be~     enrolled. At the end of surgery, four EQUANOX Advance 8004CB probes will be placed on the~     flank, lower extremities and the forehead. Continuous NIRS saturations will be monitored and~     stored for analysis. Point of care (POC) lactates will be obtained after admission to the~     intensive care unit (ICU) every 2 hours for the first 24 hours postoperatively, then once at~     48 hours. The association between NIRS oxygen saturation and POC lactate values will be~     assessed using mixed linear models taking into account the repeated measures design.~     Exploratory analyses will be performed to assess whether NIRS oxygen saturation is associated~     with outcomes such as days in ICU, adverse events and mortality.~      The ability to use noninvasive, continuous monitoring for overall perfusion and cardiac~     output will allow better and earlier therapy for neonates and infants following cardiac~     surgery.~   "
131272|NCT01849107|"~     Small bowel irradiation results in epithelial cell loss and consequently impairs function and~     metabolism. A metabolic end product of small bowel enterocytes is plasma citrulline. The~     investigators evaluate the correlation between plasma citrulline level, dose-volume histogram~     of small bowel, and small bowel toxicity grade by Common Terminology Criteria for Adverse~     Events version 4.0 (CTCAE ver.4.0) to investigate whether citrulline can be used as a~     biomarker for quantifying radiation-induced epithelial cell loss.~   "
131273|NCT01849094|"~     To determine the pharmacokinetic profile of a new (extended release) formulation of milrinone~     and to demonstrate evidence of hemodynamic effect~      Primary: Pharmacokinetic profile - to demonstrate stable plasma levels Secondary (HF cohort)~     - to demonstrate evidence of haemodynamic benefit~      Study Design: Open label~   "
131274|NCT01849081|"~     We are doing this research study to evaluate whether continuous positive airway pressure~     (CPAP), a treatment for sleep apnea, will also help treat fatty liver disease. Sleep apnea is~     a disease where a person has interruptions in their breathing while they are sleep. This can~     lead to low oxygen levels in the blood. CPAP is a mask that delivers oxygen at high pressure~     to the lungs to prevent a decrease in blood oxygen levels. CPAP is a known treatment for~     sleep apnea.~   "
131284|NCT01848951|"~     This study intends to examine this rational by comparing the infiltrative~     transversusabdominis plane (TAP) block with liposomal bupivacaine to EA in major abdominal~     surgery . The efficacy of the TAP block for abdominal surgery is well documented in the~     literature (McDonnell 2007) (Kadam 2011), but there are no studies utilizing long-acting~     bupivacaine. The investigators believe the primary outcome will demonstrate no difference~     between the two in terms of pain scores and opioid consumption. The investigators anticipate~     that patients who have undergone TAP blocks will have improved secondary outcomes with~     respect to a decreased costs, urinary retention, and hypotension.~   "
131285|NCT01848938|"~     The purpose of this study is to determine whether treatment of stress urinary incontinence~     (SUI) via smartphone is effective.~   "
131286|NCT01848925|"~     The purpose of this study is to compare the safety of SANGUINATE™ versus Hydroxyurea in~     patients suffering from Sickle Cell Disease.~   "
131814|NCT01841996|"~     This study is Randomized, Double-Blind, Vehicle-Controlled, Multiple-Dose Study.~      The purpose is to determine the safety, tolerability, systemic exposure and pharmacokinetics~     of ME1111 after repeated daily topical application of ME1111 in a maximal use setting in~     adults with distal subungual onychomycosis of the toenails.~   "
131275|NCT01849068|"~     Ezetimibe has been shown to inhibit cholesterol absorption and several lines of evidence from~     in vitro systems and animal models suggest that this effect is associated with an increase in~     low-density lipoprotein (LDL) receptor expression in the small intestine. The impact of a~     treatment with ezetimibe on intestinal gene expression and protein mass levels of LDL~     receptor and other key genes involved in intestinal cholesterol homeostasis will be examined~     in dyslipidemic men with insulin-resistance. In the present study, gene expression studies~     and protein mass levels will be assessed on duodenal biopsies by real-time polymerase chain~     reaction (rt-PCR) and liquid chromatography-mass spectrometry (LC-MS/MS), respectively. The~     primary objective of this proposal is to examine the effects of ezetimibe on intestinal gene~     expression (rt-PCR) and protein mass levels (LC-MS/MS) of LDL receptor in dyslipidemic men~     with insulin-resistance. The secondary objective is to examine the impact of ezetimibe~     treatment on intestinal gene expression and protein mass levels of sterol regulatory~     element-binding protein (SREBP)-2, Niemann-Pick C1-Like1 (NPC1L1), ATP binding cassette gene~     (ABCG)-5/8, proprotein convertase subtilisin/kexin type 9 (PCSK9) and~     3-hydroxy-3-methyl-glutaryl-CoA (HMG CoA) reductase.~      Primary hypothesis Treatment with ezetimibe 10 mg/day will significantly increase duodenal~     mRNA and protein mass levels of LDL receptor in dyslipidemic men with insulin-resistance.~      Secondary hypothesis Treatment with ezetimibe 10 mg/day will significantly increase duodenal~     mRNA and protein mass levels of SREBP-2, NPC1L1, ABCG5/8, PCSK9 and HMG CoA reductase in~     dyslipidemic men with insulin-resistance.~   "
131276|NCT01849055|"~     This is a study of LY3023703 in healthy participants. The purposes of this study are to look~     at safety, how well the study drug is tolerated, how much of the study drug gets into the~     blood stream and how long it takes the body to remove the study drug. The effects of~     LY3023703 on blood pressure after 28 days of dosing will be studied. Information about any~     side effects that occur will be collected. The study is expected to last 21 weeks.~   "
131277|NCT01849042|"~     This study will evaluate the pharmacological efficacy on language capability and compliance~     with combination of new Ebixa oral pump and donepezil compared to donepezil only in patients~     with probable Alzheimer's disease. Primary objective is to evaluate the efficacy of memantine~     on language capability in moderate to severe Alzheimer's disease patients who are taking~     stable donepezil treatment.Secondary objectives are to evaluate the efficacy of maintain on~     cognitive function and disease progression with K-MMSE, NPI, ROSA, and SIB-short form in~     probable AD.~   "
131278|NCT01849029|"~     Many American Indian (AI) women never receive services for serious mental health problems~     resulting from traumatic events, violence exposure and maltreatment. AI women suffer higher~     lifetime rates of Post-traumatic Stress Disorder (PTSD) (20-23%), that often co-occur with~     excessive drinking and risky sexual behaviors. These factors magnify risk for human~     immunodeficiency virus and sexually transmitted disease (HIV/STI). In full development with~     tribal partners, this application, proposes a 3-year project to culturally adapt and pilot an~     empirically supported trauma-focused treatment, Cognitive Processing Therapy (CPT) for PTSD,~     substance use and HIV/STI sexual risk behavior among 50 AI women. Additionally, the~     investigators will assess the feasibility, acceptability and treatment fidelity of delivering~     CPT via AI community health workers in a resource-limited tribal reservation. This project~     brings a culturally responsive intervention to an understudied and highly vulnerable~     population. Its significance lies in its potential to advance science in the area of PTSD,~     substance use treatment and HIV/STI prevention among AI women. Study data would benefit~     tribal and rural communities and the mental health field. Finally, it is geared toward~     developing the research infrastructure and mental health treatment capacity serving AI women~     living in rural settings, a group at risk for an expanding HIV/AIDS epidemic. If successful,~     findings from this pilot will provide evidence for a larger effectiveness trial.~      The AIMS are AIM I. Adapt the evidence-based CPT intervention in full collaboration with~     tribal partners. This will be done in accordance with the CDC's Map of Adaptation Process and~     involves formative research with tribal leaders, potential consumers, providers, and health~     care administrators using qualitative methodology.~      AIM 2. Assess this intervention delivered by Native American community health workers for~     feasibility and acceptability in a resource-limited rural reservation setting.~      AIM 3. Conduct a two-group, single-site waitlist randomized controlled pilot trial of a~     12-session, 6-week CPT intervention among 56 (6 pilot) sexually active and substance using AI~     women with PTSD or sub-threshold PTSD. Determine preliminary efficacy and estimate an effect~     size in terms of three primary outcomes: (a) PTSD symptomatology; (b) substance use; (c) high~     risk sexual behavior.~   "
131279|NCT01849016|"~     The primary aim of this study is to evaluate the effect of the drug N-Acetylcysteine on the~     frequency of pain in daily life in patients with Sickle Cell Disease (SCD).~      Pain is an invalidating hallmark of this disease and has a considerable impact on the Quality~     of Life of patients and the medical health care system. Oxidative stress is hypothesized to~     play a central role in its pathophysiology. In pilot studies the administration of~     N-Acetylcysteine (NAC) resulted in a reduction of oxidative stress. Moreover, administration~     of NAC seemed to decrease hospitalization for painful crises in a small pilot study in~     patients with SCD.~      This study will be performed as a multicenter, randomized, controlled trial where patients~     will be treated with either NAC or placebo for a period of 6 months. The investigators expect~     that NAC can reduce the frequency of pain in patients with SCD, thereby improving their~     quality of life and participation in society.~   "
131280|NCT01849003|"~     This mechanism of action study is to evaluate the effect of oral GS-6615 on the QTc interval~     in participants with Long QT-3 syndrome. This study will be performed in six cohorts of~     participants in a sequential manner, four single-dose cohorts followed by two multiple-dose~     cohorts. Duration of treatment for the single-dose cohorts and multiple-dose cohorts will be~     1 day and 7 days, respectively. Participants will be confined at the study center from~     check-in until completion of assessments at discharge.~      Participants will be continuously monitored using real-time telemetry throughout the~     in-clinic confinement. Physical examinations including vital signs, laboratory analysis,~     electrocardiograms (ECGs), Holter recordings and echocardiography (ECHO) will be performed at~     defined time points throughout the study period. Assessment of adverse events and concomitant~     medications will continue throughout the duration of the study.~   "
131281|NCT01848990|"~     The primary objectives of this study are to compare the difference in glycosylated hemoglobin~     (HbA1c) from baseline to Month 6 using Hylenex recombinant preadministration in continuous~     subcutaneous insulin infusion (CSII) versus standard CSII and to evaluate the safety of~     Hylenex recombinant preadministration, including local tolerability, adverse events, and~     hypo- and hyperglycemia rates.~   "
131282|NCT01848977|"~     Tissue oxygen saturation is non-invasively measured using near-infrared spectroscopy, by two~     device, INVOS®(somanetics Corporation, USA ) and InSpectra™ (Hutchinson Technology, USA).~     Each probes are attached to both thenar muscles and vascular occlusion test (VOT) is~     performed. The investigators will compare the Invos® data to InSpectra™ to investigate~     whether tissue oxygen saturation values by INVOS® can substitute for InSpectra™.~   "
131287|NCT01848912|"~     The purpose of this study is to find a way of detecting infection earlier in patients~     receiving bone marrow transplant. This is accomplished by continuous individualized~     monitoring of heart rate, respiratory rate and temperature variability in this patient~     population. The investigators are collecting data to determine whether or not subtle~     differences in heart rate, respiratory rate and temperature will help physicians to detect~     infection earlier in order to begin faster treatment before a patient's condition~     deteriorates. Blood tests will also be performed to check for certain biomarkers that may~     indicate infection~   "
131288|NCT01848899|"~     The aim of this study is to determine how two different types of iodinated contrast media~     (CM) agents, low-osmolar ionic ioxaglate and iso-osmolar non-ionic iodixanol, affect specific~     markers of thrombogenesis and platelet function in patients undergoing coronary angiography,~     and if the use of bivalirudin, a direct thrombin inhibitor used during percutaneous coronary~     intervention (PCI), affects any contrast-related changes in thrombogenesis and platelet~     function.~   "
131289|NCT01848886|"~     Coronary artery bypass grafting (CABG) using the radial artery (RA) has since the nineties~     gone through a revival. The initially reported worse outcome in RA graft patients compared to~     patients grafted with the saphenous vein (SV) has since been corrected. Studies have shown~     better patency when using RA, so the RA is going to be preferred more and more especially in~     younger patients where long time patency is critical. During the last 10 years endoscopic~     techniques to harvest the RA have evolved. Multiple different techniques have been used, but~     now the equipment and technique have been refined and are highly reliable. The investigators~     hypothesize that the endoscopic technique has less complications and a just as good patency~     as open harvest. There are also two possible ways to use the RA as a graft. One way is sewing~     it onto the aorta and another way is sewing it onto the mammarian artery. The investigators~     hypothesize that using it on the mammarian artery is superior as a revascularisation~     technique with just as good a patency as sewing it directly onto the aorta.~   "
131290|NCT01848873|"~     To evaluate the efficacy of Amlodipine-folic Acid Tablets on reduction of blood pressure and~     plasma homocystein.~   "
131291|NCT01848860|"~     Primary spontaneous pneumothorax usually occurs in young, lean male without underlying lung~     disease. In most cases, the cause of pneumothorax is rupture of blebs at the apex of the~     lung. Traditionally, bullectomy with mechanical pleurodesis through thoracotomy is indicated~     in patients with recurrence or persisted air leakage. In recent years, thoracoscopic~     bullectomy with pleural abrasion is getting popular, thanks for the advance of endoscopic~     instruments and technique. The pneumothorax recurrence rate after thoracoscopic surgery is~     around 10%, which is significantly higher than that of thoracotomy. In addition, the rate of~     postoperative prolonged air leakage is 5-8%. The possible causes of recurrent pneumothorax~     and prolonged air leakage are missed bleb surrounding the endoscopic suture line or~     suboptimal suturing or healing of the thoracoscopic suture. To prevent these complications, a~     novel method using coverage of the endoscopic suture line by a large absorbable mesh during~     thoracoscopic surgery was proved to be safe and feasible. Theoretically, the mesh can~     strengthen the suture line and induce local fibrosis surrounding the suture line, and reduce~     the rate of recurrent pneumothorax and prolonged air leakage. To prove this hypothesis, the~     investigators are conducting a prospective randomized trial in National Taiwan University~     Hospital. The investigators will enroll 204 patients with primary spontaneous pneumothorax~     who will be randomly assigned to additional mesh pleurodesis (mesh group, 102 patients) or~     not (control group, 102 patients) after thoracoscopic bullectomy and pleural abrasion. The~     primary endpoint is to compare the rate of pneumothorax recurrence within one year between~     the two groups. The secondary endpoints are to compare the safety, efficacy, and long-term~     pulmonary function between the two groups.~   "
131292|NCT01848847|"~     The purpose of the study is to investigate the advantages and disadvantages of bladder~     filling during hysteroscopy procedure.~   "
131293|NCT01848834|"~     This study is being done to investigate the safety, tolerability and anti-tumor activity of~     pembrolizumab (MK-3475) in participants with advanced triple negative breast cancer (TNBC)~     (Cohort A), advanced head and neck cancer (Cohorts B and B2), advanced urothelial cancer~     (Cohort C), or advanced gastric cancer (Cohort D). Additionally, for Cohort D, data is~     presented for Asian Pacific (AP) participants. Only participants with programmed cell~     death-ligand 1 (PD-L1) expressing tumors were enrolled in Cohorts A, B, C and D. Participants~     in Cohort B2 were enrolled irrespective of PD-L1 status.~      The primary study hypothesis is that pembrolizumab is safe and well-tolerated.~   "
131294|NCT01848821|"~     The aim of this study is to evaluate the speed and quality with which OASIS® Ultra~     (Healthpoint Biotherapeutics; Fort Worth, Texas) increases wound healing in the critical~     sized defect. The investigators intend on confirming the histological composition of the~     dermal substitute in order to delineate the amount of cellular recruitment, collagen~     deposition and neovascularization present compared with control wounds. The investigators~     hypothesize that OASIS® Ultra will provide a faster healing time as well as the~     re-establishment of a dermis for further skin graft application. The investigators anticipate~     that our study will define parameters for the application of OASIS® Ultra as well as~     potentially demonstrating the advantages in healing time, healed wound quality and hospital~     stay.~   "
131295|NCT01848808|"~     The general objective of this project is to examine the impact of Wobenzym PS supplementation~     on blood markers of inflammation and inflammation gene expression in volunteers with~     sub-clinical inflammation.~      The study will be undertaken according to a double-blind, cross over, randomized, placebo~     controlled design. The study will involve men and women with subclinical inflammation (n=24).~     Eligible subjects will have blood CRP >1 mg/L and <10 mg/L and will be in good health. The~     impact of Wobenzym PS on inflammation (vs. placebo) will be assessed by comparing the blood~     fasting concentrations and whole blood gene expression of anti- and pro-inflammatory proteins~     before and after the 4-week supplementation (Wobenzym and placebo). The two 4-week~     supplementation will be separated by a 4-week wash out period.~   "
131334|NCT01848275|"~     Catheter-based renal sympathetic modification has been documented to be effective option for~     blood pressure control in patients with resistant hypertension, but the safety is still~     concerned around worldwide. Based on anatomic findings, blocking renal sympathetic nerves at~     proximity may be enough for successful renal sympathetic modifications. This study was~     designed to compare the efficacy and safety of full length versus proximal ablation of~     bilateral renal arteries.~   "
131296|NCT01848795|"~     Obese patients with Type 2 diabetes (T2D) have a 80-98% chance of having their disease cured~     or improved following bariatric surgery. This could be explained by weight loss or by changes~     of nutrient absorption or gut hormone secretion. The comparison of glucose metabolism in~     patients undergoing malabsorptive or mechanical procedures will clarify this matter.~     EndoBarrier is an endoscopically delivered device that mimics malabsorptive surgical~     procedures while the endoscopically placed intragastric balloon induces weight loss with a~     mechanical action.~      The present study hypothesis is that the bypass of the first portion of the intestine~     obtained with the EndoBarrier will be more effective in improving glucose metabolism than the~     reduction of food intake obtained with the intragastric balloon. Since similar weight loss is~     expected in the two groups, the study will aid in understanding the mechanisms behind the~     metabolic improvement seeing after intestine bypass.~   "
131297|NCT01848782|"~     Objective: The investigators aim to evaluate the impact of a adding a  limitations  section~     in systematic review's abstract on result's interpretation by readers Design: randomized~     controlled trial with two parallel arms. Participants will be invited to participate in an~     online survey.~      Participants: Eligible participants are corresponding authors of clinical trials published~     between 2010 and 2012 and referenced in Medline.~      Intervention: The investigators will evaluate the impact of the presence of a  limitations ~     section in abstract of systematic review with meta- analysis. The investigators selected~     abstracts of meta-analysis from a sample.~      Selected abstract will be standardised and the treatment's name hidden. Two groups of~     abstract will be presented as follow: 1) abstract without  limitations  section 2) abstract~     with  limitations  section. The  limitations  section will be written by authors and will~     briefly describe the risk of bias of included studies.~      Selected participant are invited by e-mail to answer the survey. After reading one abstract~     from his/her group of randomisation they are invited to answer 5 questions about their~     interpretation of the results.~   "
131298|NCT01848769|"~     The rationale is to investigate the systemic availability of BDP/B17MP and formoterol after~     single oral inhalation of CHF 1535 50/6 pMDI vs the free combination of approved BDP and~     Formoterol pMDIs, in asthmatic children (5 to 11 years old).~   "
131299|NCT01848756|"~     Hsp90 is a chemical in the body that is involved in the promotion of cancer. SNX-5422 is an~     experimental drug that blocks Hsp90~   "
131300|NCT01848743|"~     In Taiwan, 15% of general population had hepatitis B virus (HBV) infection, HBV is the~     leading cause of liver cirrhosis and hepatocellular carcinoma in Taiwan. After entering~     immune clearance, 10-30% of patients of chronic HBV develop acute exacerbation (AE) , some~     are mild but some developed hepatic decompensation or even death.~      Previous study found that early use of lamivudine before bilirubin level is above 20 mg/dl~     can improve survival in chornic HBV with severe AE. From the study from Hongkong, lamivudine~     was found to have better survival than entecavir in chronic HBV with severe AE. Recent study~     from India found that tenofovir is able to improve survival in chronic HBV with severe AE.~     The aim of this study is to compare the effect of lamivudine and tenofovir for chronic HBV~     with severe AE.~      The study aims to enroll 120 patients with chronic HBV defined as persistence of HBsAg for~     more than 6 months. Severe AE was defined as ALT > 400 U/L, prolongation of prothrombin time~     > 3 seconds, bilirubin > 2 mg/dl. Patients with hepatitis A, C, D or HIV infection, drug or~     alcoholic liver disease, hepatocellular carcinoma, under immuno-suppressive agents use, or~     previous use of anti-HBV agents are excluded. All enrolled patients are randomized into group~     A who received tenofovir 300 mg qd for 3 years and group B who received lamivuidne 100 mg qd~     for 6 months, followed by tenofovir 300mg qd for 30 months. Mortality rate and virological,~     biochemical and serological response were evaluated at 1,2,4,48,96 and 144 weeks. The values~     are expressed as mean + SD. Categorical variables were analyzed with Chi-square test or~     Fisher's exact test as appropriate and continuous variables were analyzed by Mann-Whitney~     test. Logistic regression test was applied to analyze the independent association of various~     variables with outcome. A p value < 0.05 was regarded as significant.~   "
131301|NCT01848730|"~     To investigate the effect of repeat oral dosing of CNV2197944 75 mg tid on the pain~     experienced in post-herpetic neuralgia (PHN) as measured by changes in PI-NRS after three~     weeks of treatment compared to the baseline period.~   "
131302|NCT01848717|"~     The objective of this clinical test is to verify the safety and efficacy of MINTLIFT®, used~     for the purpose of improving the appearance of the nasolabial fold on both sides of the face.~   "
131303|NCT01848704|"~     1Randomized controlled trials (RCT) are the gold standard for therapeutic evaluation. Rapid~     dissemination of trial results and their translation into clinical practice is particularly~     important. Abstracts published or presented in conferences are a large, rapid and free method~     to disseminate these results. However, this mode of dissemination may have serious~     consequences for patients if abstracts are not an accurate and unbiased reflection of the~     trial results. Indeed, investigators have great freedom when writing their abstracts and~     articles. They can choose the data to present and decide how to present them. Consequently,~     they have many opportunities to shape readers' impressions of their results, that is, to add~     spin (ie, spin is a specific way of reporting to convince readers that the beneficial~     effect (efficacy, safety) of the experimental treatment is higher than shown by the results).~      Objective: To assess the impact of spin on the interpretation of results in abstracts of~     randomized controlled trials with nonstatistically significant results in the field of~     cancer.~      Design: The investigators performed a RCT comparing the interpretation of results in~     abstracts a) with and b) without spin.~        1. Identification of abstracts of randomized trials with spin. The investigators selected a~          sample of negative published RCTs (i.e. non statistically significant results) with a~          spin in abstract conclusion identified in previous works. Inclusion criteria were 1)~          RCTs with non statistically significant primary outcome, 2) spin in the abstract~          conclusion.~        2. Abstracts' modification Selected abstracts were systematically rewritten to contain no~          spin. All abstracts were presented in the same format without the names of authors,~          references, or the name of the journal in which it was published, and the names of~          treatments were masked by using generic terms (e.g., treatment A, comparator B). All~          abstracts had the same number of words +/-20~        3. Assessment Abstracts were assessed by corresponding authors of randomized trials,~          experts of specific grants and investigator of trials registered in clinicaltrials.gov.~          Experts were invited to participate in our study. They were not informed of the~          objectives of our study. Each clinician were randomized to evaluate 1 abstracts with or~          1 abstracts without spin.~        4. The primary endpoint was the interpretation of abstract results by the participants. All~          readers participating in the study evaluated the abstract of randomized trial and~          answered the following question: Based on this abstract, do you think treatment A would~          be beneficial to patients? (answer: numerical scale from 0-10)~   "
131304|NCT01848691|"~     People who have Sickle Cell Anemia (HbSS) produce red blood cells with shorter lifespans.~     These red blood cells breakdown faster, and this is called hemolysis. When red blood cells~     breakdown, a tiny amount of Carbon Monoxide (CO) is released into the blood and is eliminated~     in exhaled breath. This research study will use a device called CoSense™, which will measure~     Carbon Monoxide (CO) levels in breath. The purpose of the study is to see how well the device~     measures the CO levels that an individual breathes out.~   "
131335|NCT01848262|"~     Minimally invasive surfactant therapy via a small vascular catheter - ECALMIST (Early CPAP~     And Large Volume Minimal Invasive Surfactant Therapy) versus InSurE (Intubate, Surfactant~     Extubate) in preterm infants with Respiratory Distress Syndrome (RDS): A prospective~     randomized clinical trial.~   "
131862|NCT01841372|"~     The purpose of this study is to determine if use of a virtual reality platform, Second Life,~     is more effective than traditional face-to-face methods for maintaining weight loss in~     overweight and obese individuals.~   "
131305|NCT01848665|"~     Increased core temperature (hyperthermia) has been associated with impaired neuromuscular~     performance; however, the mechanisms associated with these performance decrements and their~     potential synergies remain unclear. While the majority of research suggests that the observed~     fatigue is related to the central nervous system, the influence of changes in cerebral blood~     flow (CBF) and associated changes in cerebral alkalosis (estimated by end-tidal partial~     pressure of carbon dioxide; PETCO2) remains unexamined. In response to hyperthermia, humans~     hyperventilate as means of heat dissipation, resulting in a hypocapnia (reduced PETCO2)~     mediated decrease in CBF and consequently, cerebral alkalosis (increased cerebral pH).~     Previous research suggests that hyperventilation induces changes in neural excitability and~     synaptic transmission; however, it remains unclear if these changes are related to hypocapnia~     mediated decrease in CBF or decreased PETCO2 or both.~      The purpose of the proposed research program is to examine the influence of changes in CBF~     and cerebral alkalosis on neuromuscular function during passive heat stress. The research~     project will consist of 3 separate experimental trials: (a) poikilocapnic hyperthermia~     (increased core temperature; decrease CBF; decrease PETCO2), (b) isocapnic hyperthermia~     (increased core temperature; no change CBF; no change PETCO2) and (c) isocapnic hyperthermia~     + indomethacin (increased core temperature; decrease CBF; no change PETCO2). During each~     manipulation, neuromuscular function will be evaluated and compared to baseline~     (normothermic) conditions using a repeated measures design.~      It is hypothesized that changes in PETCO2 and therefore, changes in cerebral alkalosis will~     contribute to neuromuscular fatigue independent of changes in CBF or increases in core~     temperature.~   "
131306|NCT01848652|"~     The protocol is to assess the overall response rate (complete response and partial response)~     of treatment with non-pegylated liposomal doxorubicin at a dose of 50 mg / m² in combination~     with dexamethasone in immunocompetent adult patients with primary brain lymphoma large B-cell~     refractory or relapsed after first-line treatment MTXHD and high-dose cytarabine, excluding~     strict eye lymphomas.~      This is a Phase II, open, prospective, multicenter, non-comparative with direct individual~     benefit.~   "
131307|NCT01848639|"~     This study is designed to etablish the effects of spironolactone in comparison to placebo on~     the composite endpoint of nonfatal Myocardial Infarction (MI) and acute coronary syndrome,~     hospitalization for heart failure, nonfatal stroke or cardiovascular-induced death. The~     primary endpoint will be the time to onset of the first incident.~   "
131308|NCT01848626|"~     The objectives of this study are:~        1. To collect data necessary for assessing the performance of advanced Vaginal Tactile~          Imager (VTI) and evaluating the probe ergonomic design, safety and patient tolerance;~        2. To assess the clinical suitability of the interface software to facilitate the data~          collection process and to get in vivo examination data for validation of visualization~          and analysis routines;~        3. To test the data collection technique and establish a reliable examination procedure.~   "
131309|NCT01848613|"~     Title: Randomized cross-over study of patient preference for oral or intravenous vinorelbine~     in the treatment of advanced NSCLC. A phase IV study.~      ShortTitle/ Acronym: VIVOS~      Protocol Code :IRST162.05~      Study Design: Randomized, open label cross-over study~      Study Duration: Two years~      Study Center(s): Multicenter study~      Objectives:~      Primary: Patient preference for oral or intravenous vinorelbine Secondary: Overall Response~     Rate, Time to Progression, Toxicity, Survival, Subjective reasons for treatment choice.~      Number of Subjects: 120~      Diagnosis and Main Inclusion Criteria:~      Patients affected by stage IIIB or stage IV NSCLC candidates to receive a first line~     chemotherapy with vinorelbine due to age ≥ 70 and Eastern Cooperative Oncology Group (ECOG)~     Performance status ≤2 or age ≤ 70 but ECOG PS ≥ 2~      Study Product, Dose, Route, Regimen and duration of administration :~        -  Arm A: first cycle of IV vinorelbine (30 mg/m2) and second cycle of PO vinorelbine~          (60mg/m2)~        -  Arm B: first cycle with PO vinorelbine (60mg/m2) followed by a second cycle of IV~          vinorelbine (30mg/m2) In both arms vinorelbine will be given at day 1 and day 8 every 3~          weeks. From the third cycle onwards patients will have to choose to receive oral or~          intravenous vinorelbine. Vinorelbine capsules will be administered at the dosage of 60~          mg/m2 for the first course and then may be increased to 80 mg/m² at physician's choice.~      Treatment will be repeated every 21 days and continued until disease progression, intolerable~     toxicity or patient refusal.~      Reference therapy: Vinorelbine 30 mg/m2 intravenous day 1 and 8 every 21 days~      Statistical Methodology: The sample size is calculated based on 75% of patients preferring~     oral vinorelbine and 25% preferring intravenous vinorelbine. Therefore, the investigators~     would compare patients preferring oral vinorelbine as 75% compared to a null hypothesis of~     50% (no difference in proportion of patients preferring oral to intravenous). With 80%~     power and a total alpha of 0.05, the estimated sample size is 60 for group (120 total).~     During recruitment period, a formal interim analysis was planned when 60 patients (30 for~     group) have been enrolled, with a p-value <0.0001. To claim statistical significance in the~     final analysis, the overall p-value is still 5% (referred to Peto-Haybittle rule).~   "
131310|NCT01848600|"~     Objective: The investigators aim to evaluate the impact of a  limitations  section in~     systematic review's abstract on results' interpretation by readers.~      Design: Randomized ratio 1:1 controlled trial with two parallel arms. Participants will be~     invited to participate in an online survey.~      Participants: Eligible participants are corresponding authors of randomized controlled trial~     published between 2010 and 2012 and referenced in pubmed Intervention: The investigators will~     evaluate the impact of the presence of a  limitations  section in abstract of systematic~     review with meta-analysis. The investigators selected abstracts of meta-analysis published in~     the journal Annals of Internal Medicine between 2006 and 2011.~      Selected abstract will be standardised and the treatment's name hidden. The two groups of~     abstract will be presented as follow: 1) abstract with  limitations  section and 2)~     abstract without  limitations  section: the  limitations  section of the original~     abstract will be deleted.~      Selected participants are invited by e-mail to answer the survey. After reading one abstract~     from his group a randomization they are invited two answer 5 questions about their~     interpretation of the meta-analysis's results.~   "
131311|NCT01848587|"~     Pelvic girdle and low back pain are common in pregnancy, and cause severe impairment in 10%~     of women. Our hypothesis is that offering acupuncture in addition to standard care would~     reduce pain and impairment throughout pregnancy. 300 pregnant women from 5 maternity units~     will be randomized over a 3 year period to receive standard care or standard care plus~     acupuncture. Main outcome will be the number of days during pregnancy with maximum pain ≤~     4/10. Secondary outcomes will compare groups for an impairment score and for direct and~     indirect costs.~   "
131312|NCT01848574|"~     Evaluation of global understanding and with items of patients admitted to the emergency.~      Prospective observational study randomized in cluster during 6 weeks in 14 centers~   "
131313|NCT01848561|"~     This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in~     patients with moderately to severely active UC who are treated as recommended in the product~     label.~   "
131863|NCT01841359|"~     The purpose of this study is to determine whether pramlintide (Symlin) will help to reduce~     the frequency and severity of hypoglycemia in individuals who have had gastric bypass~     surgery.~   "
131314|NCT01848548|"~     Awake tracheal intubation is the standard management for patients as risk for airway~     compromise. It is also commonly done in cases where there is significant cervical spine~     pathology i.e. cervical myelopathy or instability. The anesthetic technique used for the~     awake intubation is crucial to the patient's safety. One of the most important aspects of the~     anesthetic technique is airway anesthesia prior to placement of an endotracheal tube. The~     superior laryngeal nerve is responsible for mediating the cough reflex around the vocal~     cords. The investigators have developed an approach to reliably block the superior laryngeal~     nerve by injecting local anesthetic near the nerve in a unique approach. Injecting local~     anesthetic into or through the thyrohyoid membrane will effectively block the superior~     laryngeal nerve~   "
131315|NCT01848535|"~     Prebiotics are thought to be a potential means to prevent antibiotic-associated diarrhoea~     because of their ability to stimulate beneficial bacteria. In-vitro results showed a~     promising recovery of Bifidobacteria combined with an increase of Short Chain Fatty Acids~     (SCFA) upon Galacto-oligosaccharides (GOS) supplementation to amoxicillin-treated microbiota.~     As the microbiota is nowadays considered as a key factor in human health, a further~     understanding of the gut microbiota functioning in-vivo is essential. This understanding of~     the use of specific prebiotics may possibly be beneficial in the prevention or recovery of~     antibiotic-disturbed microbiota. As the effects of GOS supplementation on the microbiota~     composition and activity from healthy adults receiving amoxicillin have never been tested~     in-vivo, the investigators propose the current study as a proof of principle.~      Objective:~      To explore whether the promising effects of GOS supplementation on the composition and~     activity of gut microbiota from healthy adults as found by in-vitro, can also be observed~     in-vivo.~      Study population:~      10 healthy men and women volunteers, 18 - 40 yr old~   "
131316|NCT01848522|"~     The purpose of this study is to suggest system for improving patients' management through a~     detail analysis of physical therapy departments functioning~   "
131317|NCT01848509|"~     Objective: Set up an interoperable telemedicine system for the follow-up of patients with~     sleep apnea syndrome.~   "
131318|NCT01848496|"~     Regardless of the selected technique for dental impression, gingival displacement is an~     essential procedure specially when making impressions of subgingival finishing lines, because~     a moisture-free sulcus is a requirement for an effective impression.~      The objective of this randomized clinical study is to evaluate the efficacy of the~     conventional and cordless gingival displacement (GD) techniques.~   "
131319|NCT01848483|"~     The overall goal of this project is to implement and test the efficacy of an enhanced~     comprehensive multidisciplinary early palliative care (EPC) package that includes four~     motivational interviewing sessions (MI) for persons diagnosed with AIDS. We posit that the~     innovative EPC will improve quality of life, clinical and psychosocial outcomes and advance~     care planning in a cost effective manner and could promote engagement and retention in HIV~     care. If successful, it could serve as a model of early palliative care for persons with AIDS~     in the US.~   "
131320|NCT01848470|"~     The purpose of this study is to investigate the safety and tolerability of 3 multiple and~     escalating dose regimens of CG400549 administered orally in healthy volunteers.~   "
131321|NCT01848457|"~     Osteosarcoma is the most common type of bone cancer in children, adolescents and young~     adults. Treatment with surgery and a combination of three conventional chemotherapy drugs can~     cure nearly two-thirds patients with osteosarcoma, but the treatment can also cause~     irreversible damage to the kidneys and cause permanent hearing loss. The purpose of this~     study is to evaluate new approaches to prevent these side effects without interfering with~     the beneficial effects of the chemotherapy drugs on the cancer by using our knowledge of how~     the drugs damage the kidney and cochlear hair cells in the ear to selectively block these~     side effects. Preventing these side effects without interfering with the anti-cancer effect~     of the drugs will improve the outcome in survivors and may also improve the effectiveness of~     the chemotherapy regimen by preventing treatment delays and dose reductions that are often~     caused by the side effects. Patients will be carefully monitored to ensure that the new~     interventions do not adversely affect response to the treatment and do not increase the other~     side effects of the chemotherapy. Specifically, we will monitor the nutritional status of the~     patients closely and ask patients to complete a survey describing the side effects after each~     treatment cycle. We will also collect a small sample of cancer tissue at the time of biopsy~     and surgery from each patient on this study for testing to determine new classes of~     anti-cancer drugs currently under development may have a role in treating osteosarcoma. If~     effective, these new approaches to prevent kidney damage and hearing loss will be applicable~     in other types of cancers treated with the same chemotherapy drugs.~   "
131322|NCT01848444|"~     Recent international data have shown that the levels of chemical substances found in human~     milk could be at risk for breastfed infants. New data are necessary to assess this risk among~     French newborns.~   "
131323|NCT01848431|"~     The evaluation of Perfusion of free flaps in patients with moderate anaemia and possible~     reduction of the transfusion threshold.~        -  Trial with surgical intervention~   "
131324|NCT01848418|"~     The purpose of this study is to create and validate an ICF core Set for Systemic sclerosis~   "
131325|NCT01848392|"~     Physical activity seems to be a prognostic factor for quality of life and survival in~     patients with cystic fibrosis (CF). Whereas their exercise capacity has been assessed through~     medical examination, their daily physical activity has been little studied. Activity monitors~     have measured physical activity only in a few studies which considered mainly respiratory~     status and more recently bone mineral density and body composition. Determinants of physical~     activity in patients with CF remain largely unknown.~      The objective of this study is to measure daily physical activity with activity monitors in~     adult patients with CF and to investigate the determinants of physical activity, with a focus~     on extra-respiratory factors (nutritional status, diabetes, bone mineralization, anxiety~     and/or depression, cardiac impairment).~      Seventy adult patients with CF, regularly cared at the Cochin adult CF centre, will be~     recruited in a stable period during their annual review. During this assessment, laboratory~     tests will be carried out (especially parameters for nutritional status), as well as~     measurement of body composition and bone mineral density, respiratory function tests and a 6~     minute walk test, and echocardiography. Patients will wear for 7 consecutive days a~     multi-sensor armband SenseWear on the arm, to assess the intensity of physical activity in~     metabolic equivalents (METS) and steps per day. Finally, patients will complete three~     self-administered questionnaires: Quality of Life (CFQ14 +), hospital anxiety depression~     scale and physical activity.~      After a descriptive analysis of the study cohort, we will study qualitative and quantitative~     criteria related to physical activity (assessed quantitatively by the number of steps/day or~     metabolic equivalents).~      Linear regression models will then be developed to assess the independent factors associated~     with physical activity, adjusting for different variables of interest related to patients~     demographic, behavioral, clinical (respiratory and non-respiratory ) and biological~     parameters. Conversely, the predictive independent aspect of physical activity will be~     studied according to respiratory function, nutritional status and quality of life.~   "
131326|NCT01848379|"~     White blood cell membrane and surface structures are affected by the metabolic disorders and~     complications found in diabetes mellitus. Therefore, cellular activation, signal propagation,~     intracellular signaling as well as bactericidal effector functions are altered.~      When diabetic symptoms are corrected by the systemic intervention and treatment of the~     patients (Anti-diabetic Therapy/ADT, i.e. anti-diabetic medication, diet and dietetic~     supervision, physiotherapy and physical exercises), white blood cell functions will then~     normalize and reach the functionality comparable to those cells derived from healthy~     subjects.~      Gum diseases like periodontitis have long been associated with and termed complications of~     uncontrolled diabetes mellitus. Vice versa, after diabetic conditions are corrected,~     periodontitis treatment will be proven effective, when oral hygiene regimen, full mouth~     decontamination (FD, i.e. the oral use of topical antiseptics prior and after professional~     mechanical tooth cleaning, tooth as well as root surface planing, polishing as well as gum~     and soft tissue decontamination in combination with systemic antibiotics) are performed. To~     reinforce gum healing, reinfection prevention (RP) as well as supportive periodontal therapy~     (SPT) will be administered by dental professionals on an individual basis and a detailed~     schedule.~      If periodontal pockets critical for participant's self care are not eliminated by FD~     including RP and SPT, and niches >5mm after 6 month persist, patients are informed and~     offered surgical intervention as indicated for gum disease elimination.~      Dental follow up exams will be offered to all participants.~   "
131327|NCT01848366|"~     Demonstrate a response to stimulation of the posterior tibial nerve using the Biowave device~     and a microneedle patch electrode in patients with overactive bladder symptoms. The~     investigators hypothesize that after at least 6 weekly treatments there will be modest~     improvements in overactive bladder symptoms trending toward more improvement.~   "
131328|NCT01848353|"~     Among youth populations, American Indians have the highest prevalence of diabetes in the~     United States. This study will use exercise as the principal lifestyle modification approach~     to reduce the risk of diabetes in this population. The Choctaw Nation of Oklahoma has several~     excellent, but underutilized wellness facilities in their Health Services Area in rural~     Southeast Oklahoma, a low socioeconomic region. It has been established that exercise lowers~     diabetes risk, and many overweight/obese, insulin resistant American Indian youth who live in~     this region would benefit from an increase in regular exercise. The challenge is to modify~     behavior so that routine exercise is established and maintained. The proposed study will test~     whether monetary incentives can elicit greater frequency and duration of exercise in American~     Indian youth when transportation and access barriers are reduced.~   "
131329|NCT01848340|"~     This will be a two-part study in healthy adults. Part A is a phase 1, non-randomized, open~     label, single-dose, single-centre mass balance study utilizing a radiolabeled dose to~     investigate the recovery, excretion, and pharmacokinetics of oral GSK1265744 in a cohort of 6~     healthy adult male subjects. Subjects will undergo a pre-study screening visit within 30 days~     of the first dose and those who successfully pass pre-study assessments and meet eligibility~     criteria will be enrolled into the study to receive the equivalent of a 30 mg dose of~     GSK1265744 as an oral solution, containing approximately 70 microcuries (mcg Ci) [0.96~     millisieverts (mSv)] of radioactivity under fasted conditions. Blood, urine and fecal samples~     will be collected for a maximum of 504 hours (21 days) following study drug administration.~     In Part B, approximately 10 healthy male and female subjects will be enrolled to evaluate the~     single-dose safety, tolerability and PK of supratherapeutic dose of GSK1265744 150 mg~     compared with placebo. Each subject will receive a single dose of GSK1265744 150 mg or~     placebo on Day 1 under fasting conditions in the morning. Blood, urine and fecal samples will~     be collected for 336 hours (14 days) following dosing.~   "
131330|NCT01848327|"~     Background/Rationale: Cognitive problems are a common symptom in individuals with Multiple~     Sclerosis (MS). Treatment options are limited, and there is a pressing need for new~     interventions to treat MS-related cognitive impairment. Glucose (a type of sugar) is used to~     fuel the cells of the healthy brain. For people with neurological conditions such as MS,~     glucose is not converted into energy as efficiently as it would be in a healthy brain, which~     can lead to a decrease in cognitive function. Caprylic Triglyceride may work to bypass this~     problem by providing an alternative energy source that is metabolized in the liver and used~     by the brain.~      Objective: To evaluate the therapeutic effects of 90 days of caprylic triglyceride on~     cognitive impairment in multiple sclerosis.~      Design: Randomized, double blinded, placebo controlled trial of 158 subjects.~      Outcome: Change in Total Learning (Trials 1-5) on the California Verbal Learning Test-2nd~     Edition-(CVLT-II) AND Change in Symbol Digit Modalities Test (SDMT) (at day 90~   "
131331|NCT01848314|"~     Many studies have studied the effect and safety of renal denervation. However, it remains~     unknown what the exact mechanism behind renal denervation is. It can be hypothesized that a~     difference in renal blood flow occurs after treatment. In the light of this ignorance,~     current study will investigate whether renal denervation leads to a difference in renal blood~     flow after treatment with renal denervation.~   "
131332|NCT01848301|"~     Coronary allograft vasculopathy (CAV) is the leading cause of late graft failure and second~     leading cause of late mortality after heart transplantation. CAV has been associated with a~     variety of traditional risk factors for atherosclerosis; however, immune mediated injury from~     development of de-novo donor-specific antibodies after transplantation also likely plays an~     important role. Similar to the progression of traditional atherosclerosis, it is likely that~     endothelial dysfunction is the precursor to the development of intimal thickening and CAV.~      The investigators hypothesize that coronary allograft vasculopathy after heart~     transplantation as defined by progressive neointimal hyperplasia is preceded by endothelial~     dysfunction, which in turn is at least partly mediated by donor specific antibodies.~      The investigators are proposing a prospective study in humans to test the above hypothesis~     and further mechanistically understand how CAV progresses. In this study the investigators~     will test for coronary endothelial function by infusing acetylcholine into the coronary~     artery and measure intimal hyperplasia by optical coherence tomography (OCT) and compare~     findings in patients with and without donor specific antibodies.~   "
131333|NCT01848288|"~     The purpose of this study is to evaluate intra-operative phacoemulsification machine metrics~     after phacoemulsification with the CENTURION® vision system configuration compared with the~     INFINITI® vision system configuration.~   "
131336|NCT01848249|"~     Compared to chronic dialysis, kidney transplantation provides recipients with longer survival~     and better quality of life at a lower cost. In order to meet increasing demands for kidney~     allografts, kidneys from older and sicker donors are being procured. This has led to greater~     discard rates of donated kidneys as well as more complications for recipients, including~     shorter allograft survival. Available clinical models to predict kidney allograft quality~     have poor prognostic ability and do not asses the degree of kidney allograft injury. However,~     allograft injury near the time of procurement can lead to major consequences for the~     transplant recipient: greater risks of delayed graft function, poor allograft function and~     premature loss of the transplant. Our proposal is based on the hypotheses that novel~     biomarkers measured in donor urine and transport media at the time of procurement can assess~     acute and chronic kidney injury and that distinct biomarker patterns will predict allograft~     survival. In collaboration with five organ procurement organizations, we will collect urine~     samples from consecutive deceased donors and samples of transport solution for every pumped~     kidney. We will measure markers of injury, repair, inflammation and fibrosis. We will~     determine mortality and allograft survival in all patients by linkage to the United Network~     for Organ Sharing (UNOS) database (Overall Cohort). Additionally, we will perform a detailed~     chart review of a subset of recipients (detailed cohort) and will also examine associations~     between biomarkers and longitudinal graft function over five years after transplant. Early,~     non-invasive and rapid assessment of donor kidney injury could drive better allocation~     decisions and potentially reduce the rates of post-transplant complications. Further, these~     new tools could provide a platform for clinical trials of therapies for allografts and kidney~     transplant recipients aimed at ameliorating allograft injury.~   "
131337|NCT01848236|"~     We would like to determine if vitamin D insufficiency exists in different ethnic groups, if~     it has an effect on bone mass and muscle function, if it has an impact on the function of the~     cells of the immune system, and if the functioning level of these systems can be improved by~     stabilizing the vitamin D levels to within normal limits.~   "
131338|NCT01848223|"~     The purpose of this study is to evaluate the quality of life of late postmenopausal Finnish~     women and the factors affecting it.~   "
131339|NCT01848210|"~     The purpose of this study is to evaluate the efficacy and safety of the fixed-dose~     combination of coumarin and troxerutin versus placebo in the symptomatic treatment of chronic~     venous insufficiency.~   "
131340|NCT01848197|"~     RATIONALE: Adjuvant chemotherapy has been proven to reduce significantly the risk for relapse~     and death in women with operable breast cancer.In the North American Inter-Group factorial~     trial design (CALGB 9741) the concept of dosedense adjuvant chemotherapy was further tested~     in patients with node-positive breast cancer.Weekly paclitaxel after standard adjuvant~     chemotherapy with epirubicin and cyclophosphamide improves disease-free and overall survival~     in women with breast cancer.Investigators asked if dose-dense 2-week intertreatment intervals~     (supported by the use of granulocyte-colony stimulating factor) were better than the~     conventional inconvenient weekly intervals.~   "
131341|NCT01848184|"~     The objective of this study is to assess the recurrence rate following the use of PARIETEX™~     Composite Ventral Patch in primary ventral hernia repair by open approach with~     intra‐peritoneal positioning.~   "
131342|NCT01848171|"~     Hypothyroidism is a common clinical entity which is often complicated by dyslipidemia. It is~     also reported increased risk for incidence of atherosclerosis and resulting coronary heart~     disease(CHD), heart failure(HF) and cardiovascular(CV) death. The effect of L-thyroxine~     replacement treatment on serum lipid and atherosclerosis is controversial in hypothyroid~     patients, especially in those with mild or moderate subclinical hypothyroidism. The present~     study was designed to investigate whether L-thyroxine replacement was effective in improving~     serum lipid profiles and retarding atherosclerosis progress.~   "
131343|NCT01848158|"~     The purpose of this study is to determine whether acupuncture is effective at improving~     comfort in children on a ventilator in the intensive care unit. Our hypothesis is that the~     patients receiving acupuncture will require less medications to keep them comfortable than~     those who receive sham or fake acupuncture.~   "
131344|NCT01848145|"~     This is a Phase II, single-arm study of ofatumumab investigating the safety of an accelerated~     infusion schedule of ofatumumab in patients who have received at least one prior therapy for~     CLL. The primary endpoint is to evaluate the number of subjects able to complete infusion~     number 3 (2000 mg) within 15 minutes of the planned time.~   "
131345|NCT01848132|"~     Diffuse large B cell lymphoma (DLBCL) is the most common non-Hodgkin's lymphoma, accounting~     for between 30% and 50% of the patients. Although it is considered a curable disease, still~     at least 40 % of the patients will fail first line chemotherapy. The International Prognostic~     Index (IPI) score and the age adjusted IPI (aIPI) has been used since they were published to~     identify patients with different outcome.~      There is not standard therapy for young patients with DLBCL and unfavourable IPI score. The~     survival of these patients remains poor, with EFS around 40%.~      The combination of RCHOP with new drugs is an attractive approach to treat these patients.~      The goal is to evaluate the proportion of patients with Event-Free Survival (EFS) after 2~     years, with a diagnosis of DLBCL with an aIPI > 1 or an aIPI =1 with increased levels of~     beta-2-microglobulin (above the Upper Limits of Normal.)~   "
131346|NCT01848119|"~     Gabapentin has been very effective at treating pain after knee and hip operations,~     hysterectomies, and many other types of operations. A previous study at the investigators'~     hospital found that a single pre-operative dose of 600mg gabapentin produced a significant~     reduction in pain after cesarean section. However, 19% of patients complained of sedation. A~     subsequent study at the same institution looked to see if lowering the dose to 300mg would~     decrease pain scores whilst reducing the sedative side-effect seen in the first trial. The~     results were inconclusive but it provided valuable information to guide the design of this~     study.~      The purpose of this study is to see whether a preoperative dose of gabapentin, followed by a~     48 hour low-dose course will produce improvement in pain scores. This study will compare the~     efficacy of a peri-operative course of gabapentin (600mg one hour before the operation and~     200mg every 8 hours for 2 days post-operatively) and a similar course of placebo in women~     undergoing Cesarean section. The investigators' hypothesis is that a course of gabapentin~     will result in decreased pain scores and increased satisfaction.~   "
131358|NCT01847963|"~     This study is a non randomized non comparative study with two Siddha formulations~     Sindhuvallathy Mezhugu and Kalladaippu Kudineer are available in Siddha classical texts~     existing for longer period. But there is no scientific data is documented about these~     formulations. This study aimed to evaluate the efficacy of the study drugs for urolithiasis.~     After the preliminary drug standardization the clinical study is Started at The National~     Institute of Siddha Tambaram. The primary outcome measure is either the Expulsion of stones~     or Changes in the number and size of the stones with 45 days drug treatment.~   "
131359|NCT01847950|"~     The study aims to evaluate the effects of short-chain fructo-oligosaccharides on the~     frequency and constistency of stools in subjects with functional constipation~   "
131347|NCT01848106|"~     This study is designed to determine the efficacy of REG1 compared to bivalirudin in~     preventing periprocedural ischemic complications and major bleeding in patients undergoing~     PCI as a treatment for CAD. Bivalirudin has been studied in patients undergoing PCI in both~     ACS (NSTEMI and unstable angina [UA]) and elective PCI. In comparison to UFH, bivalirudin has~     shown similar rates of ischemic events while demonstrating a significant reduction in~     bleeding and an improved net clinical benefit.~      Evidence from previous studies indicates that pegnivacogin represents an extremely potent,~     chemically unique anticoagulant that can be reversed by anivamersen across multiple~     populations (refer to Section 1.2.2). The question that still remains is whether Factor IX~     (FIX) inhibition by pegnivacogin can result in fewer ischemic events than a previously~     studied agent while active control with anivamersen can preserve the benefit of reduced~     bleeding. The purpose of this study is to evaluate REG1 in an adequately powered definitive~     study with an open-label, multi-center, active-controlled, randomized design to answer that~     question.~   "
131348|NCT01848093|"~     chronic obstructive pulmonary disease (COPD) is typically associated with mucus~     hypersecretion in the airways. In health, mucin is the major macromolecular component and is~     responsible for the protective and clearance properties of the mucus gel. In a recent study~     the investigators found that mucins are decreased and unstable in the sputum of adult cystic~     fibrosis (CF) patients.~      In this study the investigators want to investigate the differences on the mucin quantity and~     quality of airway secretions during pulmonary exacerbation of patients with COPD.~   "
131349|NCT01848080|"~     In Canada, only 10 to 15% of individuals following a cerebral vascular accident (CVA) receive~     intensive rehabilitation services. The majority of individuals return home with or without~     rehabilitation services, as outpatient services are unable to meet the demand.~     Telerehabilitation is a promising alternative approach that can help improve access to~     rehabilitation services once patients are discharged home. The main hypothesis is: The~     participants who received the intervention via telerehabilitation will have a gain in their~     Community Balance and Mobility Scale (CB&M) score that will not be inferior to the gain~     observed in participants who received the intervention via home visits (less than 4 points).~     The investigators therefore postulate a non-inferiority hypothesis of the telerehabilitation~     approach compared to home visits. The secondary hypotheses are: Two to four months following~     discharge from hospital, the investigators hypothesize that the level of: 1) gain in physical~     and psychological capacities related to mobility; 2) gain in the quality of life, and 3)~     satisfaction of services received will not be inferior in the TELE group compared to the~     VISIT group and that 4) the Tele approach will be more cost-effective compared to the VISIT~     approach. The platform used will be based on a technological infrastructure that was~     developed and tested in previous telerehabilitation studies. The study is a randomized~     control trial (RCT).The study population of interest will target individuals who have had a~     stroke who stayed in a hospital. Participants will be recruited during the hospitalization~     period at each of the three sites. The investigators expect to recruit 240 participants, 120~     per group. All evaluations will be completed in the research centers/hospitals of the three~     sites and will last approximately 1.5 hours. The first evaluation will be conducted prior to~     hospital discharge (T1) to establish the baseline measures. The two other evaluations will be~     conducted 2 months (T2) and four months (T3) following discharge from hospital. The~     independent variable is individualized exercise program, based on Tai Chi. The dependant~     variables are Balance, functional mobility, physical capacities, psychological capacities~     related to mobility and balance, quality of life, satisfaction with care received, cost of~     services according to the healthcare system. The difference between the two groups will then~     be compared using a t-test. The economic analysis will be a type of cost-effectiveness.~   "
131350|NCT01848067|"~     This phase I/II trial studies the side effects and best dose of alisertib when given together~     with abiraterone acetate and prednisone and to see how well it works in treating patients~     with hormone-resistant prostate cancer. Alisertib and abiraterone acetate may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth. Androgens can cause~     the growth of prostate cancer cells. Drugs, such as abiraterone acetate, may also lessen the~     amount of androgens made by the body. Drugs used in chemotherapy, such as prednisone, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving alisertib, abiraterone acetate, and prednisone together may be an~     effective treatment for prostate cancer.~   "
131351|NCT01848054|"~     The purpose of the study was to assess the efficacy of induction treatment with~     buprenorphine/naloxone (BNX) sublingual tablet s compared with induction treatment with~     buprenorphine only. The hypothesis is that starting directly on OX219 works equally well~     (e.g. not significantly worse) as starting on buprenorphine only and switching to OX219 on~     Day 3.~   "
131352|NCT01848041|"~     This is an exploratory, proof of concept study to evaluate the safety and efficacy of~     RVL-1201 dosed once or twice daily for 14 days compared to a placebo (vehicle) control in~     patients with ptosis.~   "
131353|NCT01848028|"~     Treatment of moderate to severe Psoriasis (Pso) and Psoriasis-Arthritis (PsA) is largely~     confined to systemic therapy in Germany. Systemic therapy includes conventional systemic~     therapy (e.g. fumaric acids, methotrexate, ciclosporin A) and biological treatment (e.g.~     adalimumab, etanercept). While short- and middle-term efficacy of most systemic treatments~     has been shown in clinical studies (and is incorporated in international guidelines),~     knowledge about long-term outcomes, optimal treatment and effectiveness under real-world~     conditions is still missing. PsoBest, the German registry on the treatment of moderate to~     severe Pso and PsA started in 2008 and documents the long-term course of patients being~     administered any biologic or conventional systemic antipsoriatic drug authorized in Germany~     for the first time. The registry evaluates the long-term course of 3,500 patients with Pso~     and PsA treated with systemic antipsoriatics.~   "
131354|NCT01848015|"~     To assess the predictive value of circulating tumor cells (CTCs) for recurrence of advanced~     gastric cancer after radical resection.~      To identify the relationship between the detection of circulation tumor cells and recurrence~     patterns of gastric cancer after radical resection.~   "
131355|NCT01848002|"~     This trial was conducted in Europe. The aim of this trial was to investigate safety and~     pharmacokinetics of multiple doses of catridecacog (recombinant factor XIII, rFXIII) in~     healthy volunteers.~   "
131356|NCT01847989|"~     This trial was conducted in Europe. The aim of this trial was to investigate safety and~     pharmacokinetics of escalating single doses of catridecacog (recombinant factor XIII, rFXIII)~     in healthy volunteers.~   "
131357|NCT01847976|"~     The purpose of this study is to see if women with bone metastases from breast cancer will~     benefit from the addition of doxycycline to their standard bone-targeted therapy.~     Participants will be asked to take 100 mg of Doxycycline orally twice a day for 12 weeks.~     Blood and tissue collection will further define the mechanism of the benefits if there are~     any.~   "
131360|NCT01847937|"~     This project aims to develop high field MR techniques to detect nerve lesions in diabetic~     patients. The MRI findings will be compared to results from conventional evaluations and~     nerve conduction studies to determine the validity as part of a clinical practice.~   "
131864|NCT01841346|"~     The investigators will look at the short- (in hospital) and long- term ( 1 year)outcome in~     consecutive patients who undergo stent implantation and angioplasty in Jordan.~   "
131361|NCT01847924|"~     Patients who have suffered from stroke may develop problems with thinking. Moreover, such~     patients have a high risk of becoming demented, more dependent or dying. Therefore, further~     studies are urgently needed to find effective and safe treatments.~      Neuroaid is a Traditional Chinese Medicine which has been shown to stimulate growth of brain~     cells and connections in animals. Neuroaid may improve blood flow in the brain and functional~     recovery after stroke in patients. Neuroaid-II is a simplified formula with only the main 9~     herbal ingredients of the original formula and no animal ingredients.~      The NEURoaid II (MLC 901) assessment in cognitively Impaired not demented subjects: a pilot~     double blind, placebo-controlled randomized Trial on Efficacy and Safety (NEURITES) Study is~     a 24-week, early phase trial of Neuroaid-II in patients who have thinking problems after~     stroke. The study aims to investigate the effectiveness of the study drug in improving~     cognitive performance. The safety of the study drug will be closely monitored using adverse~     events, laboratory tests and vital signs.~      The trial is important as it aims to set new standards for the scientific evaluation of Asian~     Traditional Medicine for integration into standard medicine practice. It may potentially~     establish a novel therapeutic approach for improving cognition after stroke.~   "
131362|NCT01847911|"~     The effect of a self directed video strategy will be compared to a face to face neonatal~     resuscitation training program. The hypothesis is that both strategies are equivalent.~   "
131363|NCT01847898|"~     This is a randomized, controlled study to document and evaluate the clinical performance of~     the Vertebral Body Stenting (VBS) System in osteoporotic fractures of the thoracic and lumbar~     spine.~      The randomized, controlled trial (RCT) will compare patients with VBS and Balloon~     Kyphoplasty.~   "
131364|NCT01847885|"~     The purpose of this study is to determine if electrical stimulation (small levels of~     electricity) reduces post-stroke shoulder pain. This study involves a device called the~     Smartpatch System. The Smartpatch System delivers mild electrical stimulation to the muscles~     in the shoulder. The Smartpatch System includes a small wire (called a Lead) that is placed~     through the skin into the muscle of the shoulder. It also includes a device worn on the body~     that delivers stimulation (called the Smartpatch Stimulator).~   "
131365|NCT01847872|"~     The overall goal of this study is to identify interference between intramuscular Inactivated~     Polio Vaccine (IPV) and other vaccines (Measles Rubella and Yellow Fever) co-administered at~     nine months of age and to confirm the safety of co-administration. In addition, the study~     will compare the immunogenicity and safety of IPV when administered via different routes.~      A total of 1504 healthy infants between the ages of nine to ten months, who have completed~     their primary immunizations, including at least three doses of trivalent Oral Polio Vaccine~     (tOPV) will be recruited for this study.~   "
131366|NCT01847859|"~     The investigators aim to study the feasibility and reliability of pocket-size diagnostic~     ultrasound examinations performed by nurses of postoperative patients who have underwent~     cardiothoracic surgery in a cardiac unit.~   "
131367|NCT01847833|"~     The goals of this study are to:~        1. To improve upon and develop new innovative magnetic resonance imaging techniques that~          refine image quality and enhance performance. Improvements in these areas will have~          positive implications for medical diagnosis and treatment.~        2. To correlate MRI images with underlying disease pathophysiology in order to ensure that~          imaging accurately reflects the disease process.~   "
131368|NCT01847820|"~     To show that having less qualified personnel (non-Laboratory trained professionals) perform~     the test yields the same result as if a Laboratory trained professional performed the test.~   "
131369|NCT01847807|"~     Metabolic syndrome have the damages on tissues and organs in heart、kindey and vessels. In~     this study, prospective randomized, controlled, parallel designed ,different doses of~     Astragalus Mongolia, Gansu Longxi produce treat on the MS patients, and then use real-time~     quantitative PCR and Western Blotting to detect the index of oxidative stress~     、angiotensin-converting enzyme 2 mRNA expression and proteins.~   "
131370|NCT01847794|"~     To identify the correlation of HER2 expression in tissue and peripheral CTC. to identify the~     HER2 expression in CTCs with clinical prognosis in advanced/metastatic gastric cancer.~      Confirm the presence of CTCs are sensitive for monitoring response to chemotherapy.~   "
131371|NCT01847781|"~     The aim is to study the immune response to conjugated pneumococcal vaccination (Prevenar13)~     in Immunoglobulin G-deficient patients and healthy controls. Our hypothesis is that the~     antibody response will be impaired in patients as compared with controls. In contrast, we~     postulate that the cellular immune response will be intact.~   "
131372|NCT01847768|"~     In this study, the following subjects will be exposed to human rhinovirus (HRV):~        -  those with classification of mild-moderate asthma~        -  healthy control subjects.~      The investigators will study the kinetics of HRV-induced inflammatory and remodeling~     responses in a well characterized group of asthmatic subjects and compare these outcomes to~     those in a healthy, non-asthmatic control group.~   "
131373|NCT01847755|"~     This study is designed to test the hypothesis that patients with Traumatic Brain Injury~     (TBI)treated with Hyperbaric (HBO) will show improvement in function and an increased blood~     flow as evidenced by single-photon emission computerized tomography (SPECT) scan. Improvement~     is evidenced by increase in number of pixels on SPECT Scan and increased brain metabolism.~     Improvement may also be identified via cognitive assessments administered by Jupiter Medical~     Center Research Department.~   "
131374|NCT01847742|"~     To implement an EMDR (Eye Movement Desensitization and Reprocessing)intervention to treat the~     trauma symptoms among Syrian Refugees.~   "
131375|NCT01847729|"~     The aim of this study is to determine the current prevalence of co-addictions, including~     problem/pathological gambling, in patients receiving Opiate Substitution Treatment (OST), and~     to then compare patients receiving OST with or without a co-addiction (excluding tobacco~     dependence) in order to determine their clinical profile.~      In addition, an ancillary study to be carried out only among those patients receiving~     methadone, will aim to etablish whether a low plasma concentration of methadone, on the one~     hand, and an ultrarapid metabolizer genetic profile, on the other, are the characteristics~     most commonly associated with the presence of co-addictions. This will allow us to complete~     patient's pharmacological characterization.~   "
131865|NCT01841333|"~     This phase II trial will test whether the Hedgehog signaling pathway inhibitor PF-04449913~     can decrease disease relapse in high-risk patients with acute myeloid leukemia after donor~     stem cell transplant.~   "
131376|NCT01847716|"~     Pulmonary arterial hypertension (PAH) is a disease that causes raised blood pressure in blood~     vessels that pick up oxygen from the lungs. It has a life expectancy similar to some cancers.~     There is treatment available but there is no cure. We now know that PAH is associated with~     weakness in the muscles in the legs, which contributes to the symptoms patients' experience.~     Researchers believe that certain proteins found in high levels in the blood of patients with~     other chronic diseases can affect muscle function and growth. One of these proteins is called~     growth differentiating factor (GDF) 8, high levels of which are associated with muscle~     weakness in chronic obstructive pulmonary disease(COPD) and heart failure (HF). Interestingly~     there are drugs available which block the actions of GDF-8 on muscle cells which has been~     shown in animals to result in increased muscle size. A related protein called GDF-15 is found~     in elevated levels in patients PAH, and is linked to prognosis. Our preliminary data suggests~     that GDF-15 can also directly influence muscle size in a number of situations. We aim to~     investigate the role of GDF-15 and related molecules in the development of muscle weakness in~     patients with PAH. We will do this by measuring certain markers of muscle weakness and taking~     blood and muscle samples in patients and controls. We will then compare the levels of GDF-15~     in these tissues in those with and without muscle wasting. We hope this work will lead to a~     greater understanding of the role of GDF-15 in the development of muscle weakness in patients~     with PAH. GDF-15 levels may be important in allowing us to define which patients have muscle~     weakness. In the future we aim to perform a clinical trial of drugs which block the actions~     of GDF-15.~   "
131377|NCT01847703|"~     This study is intended to explore differences in oncologic and surgical safety between~     robotic assisted laparoscopy and conventional abdominal surgery for high risk endometrial~     cancer.~   "
131378|NCT01847690|"~     The conventional glucocorticoid replacement therapy in primary adrenal insufficiency-~     Addison's disease,renders the cortisol levels unphysiological, which may cause symptoms and~     long-term complications. Many patients take stress-doses that are extra doses of~     hydrocortisone or cortisone acetate before or during stressful physical or psychological~     events. However, the effect of such dosing has not been tested in scientific studies. In this~     double blind cross-over designed pilot trial we aim to test the effect of an extra dose of~     cortisol on physical activity and hormone levels.~   "
131379|NCT01847677|"~     Recently results have shown that Bevacizumab is active both in monotherapy and in combination~     therapy in patients with ovarian cancer. One of our objectives is to evaluate whether the~     addition of neoadjuvant bevacizumab improves the response and whether this affects the~     evolution of patients.~   "
131380|NCT01847664|"~     The purpose of the trial is to compare the efficacy of Rifamycin SV-MMX® 400 mg b.i.d. vs.~     Rifamycin SV-MMX® 600 mg t.i.d. vs. placebo in patients with acute uncomplicated~     diverticulitis.~   "
131381|NCT01847651|"~     Patients with cirrhosis of the liver may suffer from a condition called hepatic~     encephalopathy which in its mildest form as mental slowing and impaired reaction times in~     driving and machinery operation. Left untreated it may lead to deep coma. The cause is not~     fully understood but is though to be related to the inability of a damaged liver to filter~     out toxins such as ammonia in the blood, which then accumulate within the brain and result in~     altered function and swelling within certain brain cells,astrocytes. These patients also~     suffer from muscle loss, which is associated with a poor outcome. L-ornithine~     L-aspartate(LOLA) is a licensed drug in Germany and has been shown to promote ammonia~     elimination from the body in the form of urea. Some experimental studies have suggested that~     LOLA also potentially attenuates muscle loss by incorporating ammonia into muscle in the form~     of glutamine. The aim of this study is to determine cognitive and nutritional effects of 12~     weeks of LOLA administration and its effect on brain muscle structure and function in~     patients with cirrhosis.~   "
131382|NCT01847638|"~     To investigate inflammation, visual acuity and macular thickness after treatment with~     Prolensa vs Ilevro after cataract surgery.~   "
131383|NCT01847625|"~     The study will evaluate (in-vitro) the forces that are typically used for the extraction of~     pacemaker or defibrillator electrodes.~   "
131384|NCT01847612|"~     The aim of the present study is to evaluate whether the use of indocyanine green fluorescent~     cholangiography is responsible in a decrease of biliary fistula's rate in patients with liver~     diseases requiring liver resection.~   "
131385|NCT01847599|"~     The purpose of this study is to evaluate the efficacy of the implementation of an educational~     program on adherence to capecitabine alone or in combination to lapatinib.~   "
131386|NCT01847586|"~     The purpose of this study is to determine if a novel brain stimulation approach using~     magnetic stimulation (Transcranial Magnetic Stimulation [TMS]) can improve memory and~     thinking processes in individuals with mild Alzheimer's disease (AD).~   "
131387|NCT01847573|"~     The main purpose of this study is to test the safety and tolerability of different,~     increasing doses of an experimental medication called HT-100 in boys and young men with~     Duchenne muscular dystrophy (DMD). The study medication, HT-100, is a medicine that may help~     promote healthy muscle regeneration, diminish inflammation and the resulting damage to~     muscle, and decrease the scar tissue that forms in the muscles of children with DMD. In this~     study, pharmacokinetic sampling, or measurements of the amount of HT-100 in the bloodstream~     will also be taken.~   "
131388|NCT01847560|"~     This study plans to describe utilization patterns for oral anticoagulants over time in~     patients with non-valvular atrial fibrillation at risk for stroke using electronic claims~     data from a United States commercial insurance database.~   "
131389|NCT01847547|"~     This cohort study plans to identify initiators of oral anticoagulants using electronic claims~     data from a commercial insurance database to quantify associations between anticoagulant~     choice (warfarin and dabigatran) and the occurrence of selected outcomes in patients with~     non-valvular atrial fibrillation at risk for stroke.~   "
131446|NCT01846793|"~     This study is designed to demonstrate the safety and efficacy of a second transrectal~     intraprostatic injection of NX-1207 given to subjects with Benign Prostatic Hyperplasia (BPH)~     who previously received an injection of NX-1207 in an earlier U.S. clinical trial of NX-1207.~   "
131893|NCT01840969|"~     This study is aimed to evaluate the association of common carotid artery circumferential~     strain with the echocardiographic parameters of left ventricular function and the degree of~     actual hemodynamic deterioration in patients undergoing multi-vessel off-pump coronary artery~     bypass with preserved left ventricular ejection fraction.~   "
131390|NCT01847534|"~     One of the essential treatments for assisting patients in their recovery from illness is the~     provision of nutrition in a liquid form which is delivered into the stomach or as a fluid~     into the vein. Until recently the benefits of nutrition were undervalued in the critically~     ill, however, it has now become clear that targeted nutrition can positively affect a~     person's outcome. This is particularly important for patients who are significantly unwell~     and require increased amounts of nutrition to support recovery. Inadequate nutrition therapy~     leads them to rapidly lose weight, predominantly in the form of muscle loss which greatly~     contributes to their poor recovery.~      Whilst nutrition is essential for recovery, there are several issues with the delivery of~     nutrition via the stomach (the most commonly used method of delivering nutrition in the~     critically ill). For many reasons, patients are unable to tolerate large quantities of~     nutrition via the stomach and in addition to this there are hospital or procedural reasons~     for nutrition being turned off for lengthy periods of time. As such, this results in patients~     being delivered only about half of the nutrition that is planned. One potential way to~     overcome this is to deliver nutrition via the vein, whilst nutrition into the stomach~     continues, with the aim to meet the energy gap that is lost by inadequate nutrition via the~     stomach.~      In this study of 100 patients, we will deliver combined nutrition via the vein and stomach in~     50 patients and the other 50 patients will receive nutrition as per normal practice. We will~     measure important outcomes for these patients to determine if this allows us to meet~     significantly more of their nutrition needs. This study will also help us determine how best~     to design a larger study of this strategy.~   "
131391|NCT01847521|"~     Background. Increasing evidence indicates that brain inflammation is important in the~     pathogenesis of neuropsychiatric disorders, including at least a significant proportion of~     subjects with Autism spectrum disorder (ASD). Natural flavonoids, such as luteolin and~     quercetin, exhibit potent antioxidant and anti-inflammatory activities, inhibit the release~     of inflammatory mediators from human mast cells, and reduce maternal interleukin 6-induced~     autism-like behavioral deficits related to social interactions in mice. In a case series of~     37 children with ASD who took a dietary supplement containing luteolin and quercetin for 4~     months reported gains in eye contact, attention and social interaction according to parental~     reports.~      Aim. The purpose of this study was to assess the effectiveness and tolerability in white~     children with ASD of a dietary supplement containing 2 flavonoids, luteolin and quercetin,~     and the quercetin glycoside rutin.~      Methods. Fifty children (42 boys and 8 girls) divided into 2 equal age groups (4-6 years old,~     and 7-10 years) with ASD were enrolled in a 26-week, prospective, open-label trial at the 2nd~     University Department of Psychiatry at Attikon General Hospital, Athens, Greece, the Ethics~     Committee of which approved the study. The parents of all subjects were informed of the~     study's aims, including risks versus benefits of participating and not participating as well~     as the inclusion and exclusion criteria, and they written consent for participation in the~     study.~      Participants had already been diagnosed with ASD based on clinical assessments, and this~     diagnosis was corroborated at the 'Attikon' clinic by meeting the cutoff scores on both the~     DSM-IV-TR, symptom list and the ADOS algorithm. All children were medication naive. Apart~     from the diagnostic evaluation, the assessment also included a thorough medical evaluation~     comprising a physical examination and health history (including a review of allergic and~     gastrointestinal symptoms, as well as any food allergies or food intolerance). All concurrent~     interventions were thoroughly noted (type and hours), and the same was done at all visits.~     After meeting screening criteria, subjects were evaluated at the baseline visit, mid-trial~     visit at 18 weeks, and final visit at 26 weeks.~      Children were administered a dietary formulation containing 2 flavonoids, luteolin (100~     mg/capsule) and quercetin (70 mg/capsule), and the quercetin glycoside rutin (30 mg/capsule).~     The dose used was 1 softgel capsule per 10 kg (22 lb) weight per day with food for 26 weeks.~      The primary outcomes were the age-equivalent scores in the 3 domains of the Vineland Adaptive~     Behavior Scales (VABS), communication, daily living skills, and socialization. The VABS was~     chosen because the impact of an agent on adaptive functioning in real life is even more~     important for obtaining a better quality of life than just alleviation of some symptoms. The~     raw scores from the interview can be also expressed as an age-equivalent score and a standard~     score compared with those of the subject's peers. There are also supplementary special norms~     for individuals with autism. Although standard scores could be more useful in subject~     characterization, their use as an outcome measure has been proven to be less sensitive due to~     floor effects and reduced variability, especially in short time periods, and thus these~     scores underestimate change. Conversely, scores of special norms tend to overestimate change,~     as a small increase in a raw score can produce a big improvement in special norm percentile~     rank. Thus, raw scores and age-equivalent scores seem to be the most appropriate for use as~     outcome measures, with the latter being more easily interpreted as change over time.~      Secondary outcomes included the Aberrant Behavior Checklist (ABC), the Autism Treatment~     Evaluation Checklist (ATEC), and the Clinical Global Impression-Improvement score (CGI-I). To~     explore other possible effects of the formulation not captured from the aforementioned~     instruments, we chose to record any other benefits observed and reported by the parents~     during its use. For this, the primary clinician (K.F.) conducted telephone or in-person~     interviews of the parents, independently of the assessing clinician (A.T.), to discuss the~     possible gains of the child. CGI-I was also independently coded by the primary clinician with~     personal assessments as well as with information gathered by parents and, in the majority of~     cases, by the subjects' trainers.~      Compliance was monitored by softgel capsule count and the parents' assurance that the~     capsules had actually been taken at each visit; in case of a capsule count <85% of the~     prescribed dosage at midterm and at the end of the study, the subject was excluded from the~     final analysis.~      Adverse events were systematically recorded on an adverse event form by using scales~     indicating severity, relationship to the study procedures, action taken, and any therapy~     required.~   "
131392|NCT01847508|"~     The primary objective is to compare the mechanical failure risks in the first year after~     treatment.~   "
131393|NCT01847495|"~     The purpose of this study is to determine the effects of CyberKnife stereotactic body~     radiotherapy in combination with irinotecan chemotherapy in patients with colon or rectal~     cancer that has spread to the liver.~      Conventional radiation therapy has a limited role in the treatment of patients with liver~     metastases because the radiation doses are limited by liver toxicity. The CyberKnife system~     is a type of radiation machine that precisely focuses large doses of x-rays on the tumor, so~     that injury from radiation to the nearby normal tissue will be minimal. It is approved by the~     U.S. Food and Drug Administration to treat tumors, lesions and conditions anywhere in the~     body when radiation therapy is required. While the device is no longer classified as~     investigational, the best treatment dose and times are still being evaluated.~      Chemotherapy delivered with radiation therapy can increase the effectiveness of treatment,~     and may allow for a lower dose of radiation therapy to be utilized, thereby limiting negative~     side effects.~      In this study, patients will receive Cyberknife radiosurgery directed to liver metastasis for~     3-5 treatments, given every other day. Irinotecan 40mg/m2 will be administered intravenously~     daily for 3-5 days (5 treatments within 10 elapsed days), and prior to radiation therapy.~     Patients will have follow-up visits at months 1,2,4,6,9,12,15,18, 24, 30, 36, and every 6~     months thereafter for 3 years.~   "
131394|NCT01847482|"~     A multicenter, single-arm, prospective, interventional trial to evaluate therapeutic~     hypothermia with intravascular temperature management (IVTM) in post-cardiogenic cardiac~     arrest, post-return of spontaneous circulation (ROSC) patients in Japan.~      The objective of this study is to verify that therapeutic hypothermia performed by~     intravascular cooling using the investigational device (IVTM) can control body temperature~     appropriately in post-cardiogenic cardiac arrest, post-ROSC patients.~   "
131395|NCT01847469|"~     This is a randomized, controlled trial with 50 veterans diagnosed with post-traumatic stress~     disorder (PTSD) and comorbid alcohol dependence. Veterans will be randomized to receive~     either zonisamide (400 mg) or placebo for 12 weeks in a double blind fashion. Randomization~     will be done using 3:1 ratio and will be performed by our research pharmacy using a random~     assignment in blocks of 4- 3 will be assigned to active medication and 1 to placebo.~     Medication will be titrated over a 6 week titration phase followed by a 6 week treatment~     phase. All veterans will receive E-CPT-C therapy for the 12 weeks of treatment; E-CPT-C will~     be provided by trained and qualified clinicians with extensive experience providing E-CPT-C.~     Veterans will be recruited primarily through advertisement, but also through the clinical~     facilities at the VA and from other collaborators.~   "
131396|NCT01847456|"~     The researchers will investigate if brain insulin action influences peripheral insulin~     sensitivity in healthy humans.~   "
131397|NCT01847443|"~     The primary objective of this study is to compare pharmacokinetic (PK) profiles and assess~     the bioequivalence between the newly developed nicotine gums (2 mg and 4 mg) and the~     reference nicotine gums (2 mg and 4 mg) in healthy smokers.~   "
131398|NCT01847430|"~     The purpose of this study is to assess the long-term persistence of immunity to hepatitis B~     in adolescents aged 15-16 years who were vaccinated with Engerix™-B Kinder in infancy. The~     study will also assess the immune response to a challenge dose of Engerix™-B Kinder in these~     subjects.~   "
131399|NCT01847417|"~     An open label, balanced, randomized, three-treatment, three-period, six-sequence, cross-over,~     single dose, comparative bioavailability pilot study under fed conditions. For fed condition,~     after check-in, subjects will receive a standard dinner consisting (1000 - 1200 calories)~     after which they will be required to fast overnight (for at least 10 hours). Thereafter they~     will receive a non-vegetarian high calorie, high-fat breakfast (800-1000 calories) before~     dosing, and a standard meal (1700 - 1900 calories) for lunch, snacks and dinner.~   "
131400|NCT01847404|"~     An open label, balanced, randomized, three-treatment, three-period, six-sequence, cross-over,~     single dose, comparative bioavailability pilot study under fasting conditions. The treatments~     will be administered after an overnight fasting of at least 10 hours in each period. Fasting~     will continue for four hours post-dose, and then meals will be provided at specified~     intervals. Drinking water will not be permitted one hour before dosing and until one hour~     post-dose.~   "
131401|NCT01847391|"~     This is a phase 1, single-blind, randomized, placebo-controlled, multiple ascending dose~     study aimed to assess the safety, tolerability, and pharmacokinetics of GS-6615 in healthy~     subjects.~   "
131894|NCT01840956|"~     The purpose of this study is to assess the safety and efficacy of a novel, tissue-engineered~     vascular prosthesis, the Human Acellular Vascular Graft, HAVG.~      The HAVG is intended as an alternative to synthetic materials and to autologous grafts in the~     creation of vascular access for dialysis.~   "
131402|NCT01847378|"~     Ventricular tachycardia is one of the commonest cause of sudden death in chronic chagas~     disease. As most ventricular tachycardias originate from scar in patients with heart disease,~     catheter ablation is an important step in patient treatment. Identification of fibrosis prior~     to ablation of sustained ventricular tachycardia (SVT) might reduce the time of anesthesia,~     procedure time, radiation exposure and possibly the risk of complications. Knowledge of~     arrhythmia circuit within scar allows planning strategies for each procedure. Condreanu et~     al. stablished that voltages inferior to 6.52 mV (unipolar) and 1.54mV (bipolar) are useful~     tools in detecting scar during electroanatomic mapping. Accuracy, however when compared to~     magnetic resonance imaging is limited due to difficulties in maintaining good contact between~     ablation catheter and ventricular wall. Contact force catheters might help increase accuracy~     of voltage mapping because they allow detection of poor contact areas. Although the threshold~     for identification of scar in ischemic and non ischemic patients during electroanatomical~     mapping is already known, this parameters still lacking for chronic chagasic individuals. A~     marked qualitative histological difference between these fibrous scars supports the~     hypothesis that voltage scar in chagasics might be different. Catheter ablation contact with~     endo and epicardial surface is an important issue when ablating arrhythmias. Conventional~     catheter ablation is not equipped with sensors capable of detecting degree of contact with~     the target. To our knowledge, the literature lacks information in regard to late lesions~     produced by a known contact force pressure in vivo. The pattern of electrical activation in~     these patients and their relationship with local coronary veins for resynchronization likely~     to approach through the coronary sinus can be useful in defining chagasic that can benefit~     from resynchronization.~        1. Compare endocardial and epicardial impedance and voltage using CARTO 3 with fibrosis on~          3T MRI~        2. Correlate areas of late activation within scar during activating mapping in sinus rhythm~          with different signal intensity in 3T MRI~        3. Evaluate the influence of contact pressure during application of radiofrequency in~          making fibrosis analyzed 30 days after the procedure using a 3T MRI.~        4. Assess the site of latest left ventricular activation in sinus rhythm and correlate with~          the coronary veins location~   "
131403|NCT01847365|"~     Retinitis pigmentosa (RP) is a progressive degenerative disease of the retina, which often~     leads to blindness. 1 in 4000 people in the UK are affected by RP yet there is no established~     therapy for treating or delaying its progression.~      Transcorneal electrical stimulation (TES) has garnered attention as a possible therapeutic~     option for RP. Research has shown that TES improves retinal cell viability and visual~     function. An initial pilot study of TES on 24 participants with RP demonstrated that it was~     safe and improved vision.~      This study aims to confirm the safety of the new CE-approved Okustim device and to further~     characterise the benefits of TES on a larger scale. 12 participants will be enrolled for 1~     year across two sites in the UK - the Oxford Eye Hospital and London Moorfields Eye Hospital.~      Recruited participants will undergo weekly TES of 1 eye for 30 minutes for a period of 6~     months. This will be followed by a further 6 months of observation without stimulation giving~     a total participation time of 1 year. Participants will be assessed at 3, 6, 9 and 12 months~     after their initial baseline visit by clinical examination, investigations and~     questionnaires.~      Participants should have a diagnosis of RP and be capable of giving consent. Participants, or~     a carer, should have sufficient motor skills to attach the device themselves. As this study~     seeks to ascertain the impact of TES on RP, participants with other eye diseases (e.g.~     diabetic retinopathy) cannot be included in the study.~   "
131404|NCT01847352|"~     On exposure to hypoxia (low oxygen) the normal response is for pulmonary arterial systolic~     blood pressure (PASP, blood pressure through the lungs) to increase. We have previously shown~     that raising iron by giving an infusion of iron into a vein reduces this pressure rise and~     that lowering iron by giving a drug that binds iron, magnifies this response. This is~     potentially a clinically important observation since iron-deficient people may be at~     increased risk of pulmonary hypertension if exposed transiently or permanently to hypoxia due~     to lung disease or residence at high altitude; furthermore if this were true then intravenous~     iron could be an important treatment in this patient group in the event of hypoxic exposure.~     The observed effects of iron on PASP are likely to be because iron levels affect oxygen~     sensing. Low iron levels make the body behave as if exposed to low oxygen by inhibiting the~     breakdown of the family of oxygen-sensing transcription factors, 'hypoxia inducible factor'~     or HIF. This includes one of the body's normal responses to low oxygen levels - raising blood~     pressure through the lungs.~      This study will answer the question (1) do iron-deficient volunteers have a greater rise in~     PASP with hypoxia than those who are iron-replete, and (2) does giving intravenous iron cause~     a greater reduction in the rise in PASP in those who are iron-deficient than iron-replete?~     The purpose of this study is not to test the safety or clinical efficacy of iron which is~     already known.~   "
131405|NCT01847339|"~     The effective relief of pain is of paramount importance to anyone treating patients~     undergoing surgery. Post-operative pain increases the possibility of post-surgical~     complications, raises the cost of medical care, and most importantly, interferes with~     recovery and return to normal activities of daily living. Therefore pain control is essential~     in the management of patients undergoing spinal surgery.Parenteral administration of~     narcotics has been the mainstay for postoperative pain relief in patients undergoing~     laminectomy and discectomy. Epidural and intrathecal opioids are also effective means of pain~     control in several major surgical interventions including spinal surgery. However, some of~     the side effects have limited their widespread use (eg, late-onset respiratory depression).~     Therefore, alternative measures of pain control including infiltration of paraspinal~     musculature with local anesthetics have been investigated with conflicting results. In~     situations such as laminectomies, where the epidural space is exposed as part of the surgical~     procedure, the application of absorbable gelatin sponge soaked in local anesthetics appears~     to be an alternative for providing postoperative analgesia. By investigating the probable~     analgesic effects of this method the investigators may relieve post laminectomy pain with~     minimal side effects and also costs.~   "
131406|NCT01847326|"~     This phase I trial studies the side effects and best dose of paclitaxel albumin-stabilized~     nanoparticle formulation when given together with carboplatin followed by chemoradiation in~     treating patients with recurrent head and neck cancer. Drugs used in chemotherapy, such as~     paclitaxel albumin-stabilized nanoparticle formulation, carboplatin, fluorouracil, and~     hydroxyurea, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill~     tumor cells. Giving paclitaxel albumin-stabilized nanoparticle formulation followed by~     chemoradiation therapy may be an effective treatment for head and neck cancer.~   "
131447|NCT01846780|"~     Patients with unilateral post-thrombotic obstruction of the iliac tract and or common femoral~     vein, eligible for stenting are included. Intravenous pressure is measured in both dorsal~     foot veins and both common femoral veins. Patients are asked to undergo a standardised~     treadmill test (3.2km/h, 0% slope that increases by 2%/2min, maximum walking time 26 min).~     Painfree and maximum action radius are noted.~   "
131448|NCT01846767|"~     The purpose of this study is to determine if oxidation of 13C glucose to 13CO2 is changed in~     type 2 diabetic patients.~   "
131407|NCT01847313|"~     Diabetic kidney disease (DKD) is a devastating complication of diabetes, that in it's worst~     form, can lead to early cardiovascular death or kidney failure. A group of medicines used to~     treat diabetes, glucagon-like-peptide-1 analogues (GLP-1), may be able to protect people with~     diabetes from DKD by reducing inflammation in the kidney. This study aims to test this theory~     by studying the effect of GLP-1 on kidney function in people with diabetes.~      To understand how GLP-1 can affect inflammation, the investigators will give a GLP-1~     treatment (Liraglutide) to people with DKD and monitor the effect on inflammation and kidney~     function using blood and urine tests. The investigators will compare these results to~     patients with DKD who do not receive GLP-1 treatment.~      If GLP-1 proves to be effective in reducing inflammation and improving kidney function, then~     it could be developed as a viable new treatment for people with DKD, and may significantly~     reduce the disease burden, or the risk of DKD, in people with diabetes. This would be a major~     advance in the treatment of DKD.~   "
131408|NCT01847300|"~     The goal of this project is to test the efficacy of a computer-facilitated Screening and~     Brief Intervention system adapted for Military use (cSBI-M) in reducing substance use among~     18- to 25-yr-old U.S. Navy and U.S. Marine Corps personnel (USN/USMCs). The aims and~     hypotheses of this project are to: 1)Test the effects of cSBI-M on any alcohol use.~     Hypothesis: Among 18- to 25-yr-old USN/USMCs coming for routine health screenings, those~     receiving cSBI-M will have lower rates of any alcohol use at follow-ups compared to TAU. 2)~     Test the effects of cSBI-M separately as a preventive, early therapeutic, and risk-reduction~     intervention. Hypotheses: (a) Among 18- to 25-yr-old non-drinking USN/USMCs (negative history~     of past-12-months drinking at baseline), those receiving cSBI-M will have lower rates of~     drinking initiation and heavy episodic drinking (HED, a.k.a. binge drinking). (b) Among 18-~     to 25-yr-old drinking USN/USMCs, those receiving cSBI-M will have higher rates of drinking~     cessation, reduced intensity of drinking (e.g., past-3-months drinking days, HED, and driving~     after drinking or riding with a drinking driver.(3) Test the effects of cSBI-M on tobacco~     use; explore its effects on other drug use. (4) Assess potential moderators (e.g., age,~     gender, race/ethnicity, substance use history +/-, parent/sibling/peer substance use),~     mediators (e.g., Patient to Provider Connectedness,17 perceived harmfulness of alcohol and~     drug use), and explore cSBI-M's mechanism of action. Hypotheses: among 12- to 18-yr-old~     patients coming for routine care, those receiving c-ASBI will have 1) lower rates of any~     alcohol use, of drinking initiation and riding with a driver who has been drinking, and 2)~     higher rates of drinking cessation, reduced intensity of drinking, heavy episodic drinking~     and driving after drinking or riding with a driver who has been drinking.~   "
131409|NCT01847287|"~     The primary aim of this study is to evaluate the effect of using Tysabri on changes in the~     brain using MRI and on disease progression in patients with relapsing-remitting Multiple~     Sclerosis over 5 years.~   "
131410|NCT01847274|"~     This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of~     niraparib as maintenance in platinum sensitive ovarian cancer patients who have either~     gBRCAmut or a tumor with high-grade serous histology and who have responded to their most~     recent chemotherapy containing a platinum agent. Niraparib is an orally active PARP~     inhibitor. Niraparib or placebo (in a 2:1 ratio) will be administered once daily continuously~     during a 28-day cycle. Health-related quality of life will be measured by the Functional~     Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI), European Quality of Life scale,~     5-Dimensions (EQ-5D), and a neuropathy questionnaire. Safety and tolerability will be~     assessed by clinical review of adverse events (AEs), physical examinations,~     electrocardiograms (ECGs), and safety laboratory values.~      The primary objective of this study is to evaluate efficacy of niraparib as maintenance~     therapy in patients who have platinum sensitive ovarian cancer as assessed by the~     prolongation of progression free survival (PFS).~   "
131411|NCT01847261|"~     During aging there is a tendency for muscle protein synthesis (growth) to become less~     efficient and the resulting consequence leads to reduced muscle mass (sarcopenia) which can~     affect strength and mobility. Protein consumption may be one opportunity to alleviate this~     problem especially when consumed in appropriate amounts following resistance training. This~     study is designed to determine if a soy dairy protein blend, shown to be effective in younger~     adults, will produce beneficial muscle protein synthesis in older healthy adults following~     resistance exercise.~   "
131412|NCT01847248|"~     -  Molecules indicating endothelial injury may serve as biomarkers for severe sepsis~          because of the critical role of endothelial injury in organ dysfunction during severe~          sepsis.~        -  HSPA12B is primarily located in endothelial cells and detectable during sepsis.~        -  The investigators speculated that HSPA12B from endothelial cells might be correlated~          with severe sepsis.~   "
131413|NCT01847235|"~     The purpose of this study is to determine the efficacy and safety of temozolomide in patient~     with relapsed or advanced anaplastic oligodendroglioma and anaplastic oligoastrocytoma.~   "
131414|NCT01847222|"~     Safety assessment of SANGUINATE™ in Healthy Volunteers.~   "
131415|NCT01847209|"~     This is a phase II protocol to determine the safety and feasibility of Intraoperative CT~     fluoroscopy guidance for lung resection for small nodules.~   "
131416|NCT01847196|"~     The primary objective of this clinical trial is to obtain initial insights into the safety of~     the Angel® Catheter in critically ill subjects with high risk of venous thromboembolism (VTE)~     disease AND who are not receiving pharmacological thromboprophylaxis.~   "
131417|NCT01847183|"~     The purpose of this research is to create and evaluate the efficacy of an exciting (fun to~     use), and potentially disseminable computer-based prevention program, Click City®: Alcohol,~     for use by 7th graders with a booster in 8th grade students. The ultimate goal of Click~     City®: Alcohol is to prevent the onset of heavy drinking during high school and post-high~     school. Secondary goals of the program include decreasing students' intentions and~     willingness to engage in heavy drinking in high school. The proposed program is unique both~     in its delivery system and the development process.~      Aim 1: The investigators plan to develop and test approximately 24 components over the first~     two years of the study.~      Aim 2: The final Click City®: Alcohol program will consist of 12 effective components~     delivered in six sessions over a three-week period in 7th grade. This is followed by two~     booster sessions, consisting of a total of 5 components delivered over a one-week period in~     8th grade. Educational newsletters to parents and teacher guides will accompany the program.~      Aim 3: Following development, the investigators will conduct a group randomized trial to~     evaluate the efficacy of this program as compared to schools' usual alcohol prevention~     curriculum. The investigators plan to recruit, stratify and randomly assign 26 middle schools~     to one of the two conditions, Click City®: Alcohol and Usual Curriculum (UC). Students in the~     Click City®: Alcohol and yoked UC schools will be assessed prior to the beginning of the 7th~     grade program, following the 7th grade program, following the 8th grade booster, which would~     occur approximately one year after the 7th grade program, and a follow-up assessment in the~     9th grade to assess long-term outcomes, one year after the 8th grade assessment.~   "
131418|NCT01847170|"~     The human immune system is usually tolerant of the millions of beneficial commensal bacteria~     (the microbiome), which colonize the healthy intestinal tract. In contrast, patients with~     Inflammatory Bowel Disease (IBD) may play host to an imbalanced mix of such intestinal~     bacteria, which initiates abnormal immune responses in susceptible individuals. The resulting~     inflammation that occurs in the gastrointestinal tract damages the intestinal lining, leading~     to symptoms (such as intractable diarrhea, pain or weight loss), heightened cancer risk,~     other serious complications with substantial morbidity and even death. Current therapies for~     IBD focus on suppressing the excessive immune response to these bacteria, but have major side~     effects and do not address any role of the microbiome in disease development.~      The investigators hypothesize that there is heightened intraluminal generation of~     pro-inflammatory factors by luminal pathogenic bacteria, such as extracellular nucleotides~     and purinergic derivatives, which trigger host immune cells. This results in loss of~     suppressive T regulatory cells with unrestrained immune cell deviation to pathogenic T helper~     cells that cause inflammatory responses. The investigators' proposal is that correcting the~     disease-provoking microbiome would beneficially improve gut microbial diversity, alter immune~     responses elicited in patients by such microbial products of pathogenic bacteria, and~     ultimately limit and suppress disease activity.~      To test the hypothesis, the investigators propose to enroll patients with active Crohn's~     Disease, and introduce the microbiome of healthy and unrelated individuals to patient's~     intestinal tract, via fecal biotherapy (FBT) with all applicable safety measures. The~     investigators propose to comprehensively test the effects of FBT on the host microbiome,~     determine microbial production of inflammatory nucleotides and derivatives, which the~     investigators suggest might impact the host immune response and disease activity in patients~     with IBD.~   "
131419|NCT01847157|"~     Background and purpose:~      About 30% of people with stroke suffered from severe long-term upper extremity （UE） motor~     impairment. Severe UE impairment, especially dysfunction of hand, can greatly impact stroke~     patients' daily living independence and quality of life. However, treatment effect of current~     interventions is still limited. Nick Ward and Leonardo Cohen suggested 5 intervention~     strategies for stroke motor recovery: （1） reduction of somatosensory input from the intact;~     （2） increase in somatosensory input from the paretic; （3） anesthesia of a body part proximal~     to the paretic hand; （4） activity within the affected motor cortex may be up-regulated; （5）~     activity within the intact motor cortex may be down-regulated. Recent studies have shown each~     strategy to be effective in stroke patients with mild or moderate UE impairment. However,~     evidence for people with severe UE impairment after stroke remains unclear. Since research~     has found a greater effect for combined strategies than a single strategy, this proposal~     develops a combined intervention with the above 5 strategies, named transcranial direct~     current stimulation （tDCS） combined sensory modulation intervention. This intervention is~     expected to be most effective for people with severe UE impairment after stroke.~      In addition, neuroimaging can provide in vivo information about the brain plasticity which~     underpinning the motor recovery after stroke. However, image indexes that can be used in~     stroke patients with severe UE impairment remained examined. Therefore, this proposal has 3~     aims: （1） to examine the treatment effect of the tDCS combined sensory modulation~     intervention in stroke patients with severe UE impairment; （2） to examine the underline~     mechanism of the efficacy of tDCS combined sensory modulation intervention using~     neuroimaging technology.~      Methods:~      This study is a double-blinded randomized controlled trial which will recruit 60 people who~     have had stroke onset more than 6 months and have severe UE motor impairment. All~     participants will be randomly assigned into 2 groups. The experimental group will be given~     the tDCS combined sensory modulation intervention, combining bilateral tDCS stimulation,~     anesthesia techniques and repetitive passive motor training. The control group is given sham~     tDCS, sham anesthesia and repetitive passive motor training. Each group will be evaluated for~     outcomes at 4 time points （i.e. baseline, post-intervention, 3 months and 6months~     post-intervention）. The immediate and long-term effect of the interventions will be examined.~      Primary outcome indicators include upper extremity impairment measures. Secondary outcome~     measures include upper extremity function, activities of daily living function, functional~     Magnetic Resonance Imaging （fMRI）, and corticospinal tract structural integrity using~     diffusion spectrum imaging （DSI）. Fifteen subjects of each group will be assessed 2 times~     （i.e., prior to the intervention and after the intervention） for fMRI and DSI scan.~      Anticipatory results and contributions:~      The results of the studies are expected to present a potentially effective intervention for~     stroke patients with severe impaired UE motor. Imaging evidence of brain plasticity for this~     particular intervention is also provided. The results will contribute to our understanding of~     brain plasticity for UE motor recovery after stroke. Findings from this proposal may help~     researchers and clinicians choose or develop interventions that are optimal to their clients~     individually.~   "
131420|NCT01847144|"~     Response to treatment in Type 2 Diabetes is highly variable; the same medicine may have~     little effect in one person but a large effect in another. Understanding mechanisms of~     altered response to treatment could aid treatment selection and assist the design of new~     medications with lower nonresponse rates.~      This study will examine the physiological mechanisms and potential clinical/biomarker~     predictors of altered response to sulphonylurea and DPPIV inhibitor glucose lowering~     medication and answer fundamental methodological questions for the future study of variation~     in treatment response in Type 2 Diabetes. Participants will withdraw sulphonylurea therapy~     for up to 2 weeks with assessment of baseline characteristics and glycaemic response.~     Participants will then enter an optional extension where they receive sulphonylurea or DPPIV~     inhibitor therapy in crossover fashion.~   "
131421|NCT01847131|"~     Background Allergic rhinitis is a common health problem with a worldwide prevalence is~     10-25%, and poses significant impact on the quality of life of the patients. In Thailand, the~     prevalence of allergic rhinitis in the general population is 13.5%, of which the frequency of~     allergic rhinitis increased from 23% to 38% in the children, and 61.9% in the graduate~     students. Despite intranasal steroid being the current first-line treatment of patients with~     allergic rhinitis, only 60% of patients achieve excellent control. Persistent nasal~     congestion is the major symptom which is difficult to control in these patients. Data are~     limited about efficacy and safety of the additional use of 0.05% intranasal oxymetazoline~     hydrochloride (OXY) for persistent nasal congestion that does not adequately respond to~     recommended doses of intranasal steroid (INS) and oral antihistamine(OAH).~      Objective To determine the efficacy and safety of the additional use of OXY for persistent~     nasal congestion in allergic rhinitis or non-allergic rhinitis patients inadequately~     controlled by combination treatment with INS and OAH.~      Methods The investigators performed a 6-week, randomized, double blind, placebo controlled,~     clinical trial in 50 patients with allergic rhinitis or non-allergic rhinitis whom~     inadequately controlled by combination treatment with INS and oral antihistamine (OAH). After~     an initial screening, qualified individuals were randomized into 2 groups including the~     treatment group and the control group. The treatment group received the INS (2 puffs in each~     nostril twice daily) and OAH (1 tablet once daily) plus OXY (2 puffs in each nostril twice~     daily) The control group received INS (2 puffs in each nostril twice daily) and OAH (1 tablet~     once daily) plus placebo (2 puffs in each nostril twice daily).~   "
131422|NCT01847118|"~     This study is to assess the safety, tolerability and pharmacokinetics of single dose and~     multiple doses of humanized anti-VEGF monoclonal antibody (Sevacizumab) in patients with~     advanced or metastatic solid tumors. The secondary objective is to explore the preliminary~     anti-tumor effects.~   "
131423|NCT01847105|"~     Tolerability is compared between two Multi-purpose disinfecting solutions (MPDS).~   "
131424|NCT01847092|"~     The purpose of this study is to determine if the study drug is safe, tolerable and active in~     reducing albuminuria in patients with Chronic Kidney Disease with Type 2 Diabetes.~   "
131425|NCT01847079|"~     PROBIC~      Rationale: Procalcitonin measurements can reduce the number of blood cultures in the ICU.~      Objective: The investigators suggest that PCT is a marker for blood stream infection in all~     patients in the ICU in whom attending physicians/ intensivists order blood culturing in the~     suspicion of microbial infection. The investigators want to demonstrate that its use for~     guiding blood culturing is cost-effective and safe compared with blood cultures alone.~      Study design: Prospective, non- inferiority, multicenter, single-blinded, cluster- randomised~     cross-over clinical trial.~      Intervention (if applicable): The intensive care units will be allocated into two groups: a~     control group (blood culture) and the intervention group (procalcitonin).~      Main study parameters/endpoints: Safety, expressed as mortality at day 28 and 90, with a~     mortality difference not exceeding a between groups difference of 10% by non-inferiority~     analysis.~      Cost-effectiveness, expressed in euro, calculated by deducting costs of procalcitonin testing~     from saved blood cultures compared with standard treatment spending on blood cultures in the~     control group.~      ICIS~      Rationale: The aim was to evaluate the Intensive Care Infection Score (ICIS) in predicting~     microbial infection and its sequelae in critically ill patients in whom attending physicians/~     intensivists order blood culturing in the suspicion of microbial infection.~      Objective: Because of the complexity of the pathophysiology of systemic inflammation it is~     unlikely that a single parameter will have sufficient diagnostic accuracy for infection.~     Therefore we will study combining parameters producing a diagnostic score.~      Study design: Prospective, multicenter, cohort trial. Supplement for the control arm of the~     ProBIC study.~      Intervention (if applicable): Blood is drawn for daily routine laboratory measurements and~     collected in K3EDTA aliqnots. The ICIS score is composed of five blood-cell derived~     parameters which can be extracted using the same aliqnots.~      Main study parameters/endpoints: To develop and evaluate a blood- cell derived score to~     enable the diagnosis of microbial infection, its likelihood, its invasiveness and severity.~   "
131426|NCT01847066|"~     To assess the safety and efficacy of an ablative fractional, 2940-nm laser combined with the~     US Impact and cosmetic -formulations for improving the appearance of wrinkles, acne scars and~     pigmented skin.~   "
131427|NCT01847053|"~     A partial double-blind, randomized, placebo-controlled, 4-treatment crossover study design~     will be used to evaluate bioavailability of various forms of cinnamon and to determine the~     effects of 3 and 6 g of cinnamon added to instant oatmeal on blood glucose levels in 8~     healthy subjects. In the extended dose response study, three subjects will continue the study~     and be offered 5 day consecutive feedings of 9 g cinnamon extract and on Day 6, and blood~     samples would be collected over 6 hours after a single morning dose. Urinary samples would be~     collected upon to 48 hours.~   "
131510|NCT01845961|"~     The objective of this proof-of-concept pilot study to evaluate galantaminehydrobromide~     extended-release (ER) as a potential smoking cessation aid in treatment-seeking smokers.~   "
131428|NCT01847040|"~     The study will provide evidence on the long term outcomes of mTBI in service members~     returning from Afghanistan and Iraq. In addition, the study will provide evidence on mTBI~     incidence, and symptom patterns. Self-reported assessments at baseline and follow-ups will be~     combined with data on health care utilization and military job performance. The work,~     symptoms, and family interaction outcomes of returning soldiers screening positive for mTBI,~     combined mTBI and PTSD, and soldier controls will be compared at 3 months, 6 months, and at~     one year. The assessments over time will permit descriptions of symptom changes for these~     populations. It is likely the study will find similar findings to those of previous civilian~     studies - that concussive symptoms often resolve within months of injury. However, some~     soldier subsets may have chronic problems. Determining the incidence and outcomes of~     individuals with mTBI will assist medical providers in determining the types of follow-ups~     needed by returning service members and suggest the development of additional treatment~     interventions. These results may also inform treatment of civilian populations with mTBI.~      The three primary hypotheses are:~        1. Concussive symptoms at the time of return from serving in Afghanistan and Iraq and~          symptoms persisting 3 months, 6 months, and 12 months after return will be associated~          with extent of exposure to combat, injury mechanism, associated injuries (co-occuring~          injuries), PTSD and other psychiatric co-morbidities, and number of deployment-related~          mTBIs.~        2. Returning troops reporting concussive symptoms at the time of return from deployment~          will have more work related problems at each follow-up (including lower rates of return~          to duty, return to work, and poor quality of work).~        3. The mTBI screening tool will be sensitive and specific to mTBI when compared to the~          criterion measure, which is a structured interview conducted by clinicians blinded to~          the screening results.~   "
131429|NCT01847027|"~     The purpose of this study is to see if an investigational supplement called NutraStem® will~     increase the amount of stem cells in human blood at rest and after exercise. The ingredients~     found in NutraStem® can be found in nutrition or vitamin shops/stores.~   "
131430|NCT01847014|"~     SYMPHONY Extension is an extension of AC-055-401, a multi-center, open-label, single-arm,~     Phase 3b study of macitentan in patients with Pulmonary Arterial Hypertension to~     psychometrically validate the PAH-SYMPACT instrument. The objective is to assess the~     long-term safety of macitentan in subjects with PAH beyond the treatment in the AC-055-401~     study.~   "
131431|NCT01847001|"~     This study is being conducted in patients with newly diagnosed breast cancer that will be~     undergoing chemotherapy prior to surgery - neoadjuvant chemotherapy. The study involves~     treatment with standard chemotherapy and a commonly used, FDA-approved, blood pressure drug~     called propranolol (Inderal). The purposes of this study are to:~        1. Determine the effect of propranolol plus chemotherapy on breast cancer cells as well as~          the growth of blood vessels surrounding breast cancer cells.~        2. Determine the side effect profile of propranolol and chemotherapy in patients with~          breast cancer receiving neoadjuvant chemotherapy.~      This research is being done because previous laboratory work has shown that propranolol may~     decrease the ability for the blood vessels around breast cancer cells to grow, which may be~     important in helping cancer cells grow. It also may reduce the likelihood for breast cancer~     cells to spread. If changes are seen in the breast cancer cells and surrounding blood vessels~     in this study, we will pan to evaluate whether propranolol decreases the likelihood of breast~     cancer from recurring in future, later studies. All chemotherapy regimens used in this study~     have been the standard of care for many years; however, the use of propranolol is being~     researched along with the chemotherapy regimens.~   "
131432|NCT01846988|"~     The purpose of this research study is to determine if auto-adjustable positive airway~     pressure (APAP) is an effective way to treat obstructive sleep apnea (OSA) in children. APAP~     is a device similar to continuous positive airway pressure (CPAP) that delivers pressure to~     the upper airway (nose and throat) to keep the airway from collapsing while during sleep. The~     difference is that APAP adjusts the pressure throughout the night with changes in resistance~     during breathing, and CPAP gives the same amount of pressure the whole time it is worn. APAP~     is currently widely used to treat adults with OSA, however, this device has not yet been~     extensively studied in children.~      There are two parts to this research study. Subjects will begin using APAP at the time of~     enrollment for 4 to 8 weeks. The investigators will compare the pressure measured by the APAP~     device over the 4-8 weeks with the pressure determined by a CPAP titration study. The~     titration study is a second overnight sleep study that is routinely ordered when a child with~     sleep apnea starts treatment with CPAP. It tells the doctor what CPAP setting should be used.~      In the second part of this study The investigators will compare the effects of APAP with CPAP~     to see what is reported as more comfortable and is used during more hours of sleep. This part~     of the study will last about 8 weeks and each subject will use both CPAP and APAP for 4 weeks~     each.~      Currently when someone is diagnosed with OSA there is a delay in starting treatment with CPAP~     until the results of the titration study are available. In this research, patients could be~     allowed to immediately start treatment with APAP. If APAP is found to be as safe and~     effective as regular CPAP, treatment with APAP could be used as an alternative to CPAP.~   "
131433|NCT01846975|"~     RA (rheumatoid arthritis) patients effectively treated weekly with SC (subcutaneous)~     Abatacept will be switched to IV (intravenous) Abatacept and restarted with SC Abatacept four~     after IV application. The investigators hypothesize that a switch from SC- to IV-abatacept~     and back in patients with low disease activity is safe and not associated with a worsening of~     the disease.~   "
131434|NCT01846962|"~     Therapeutic strategies for eosinophilic esophagitis (EoE) actually include: 1) allergen~     avoidance through dietary modifications, and 2) pharmacologic antiinflammatory therapy.~     Medical treatment is mainly based on topical administration of corticosteroids by swallowing~     fluticasone propionate or budesonide spray. Dietetic treatment with highest efficacy is~     elemental diet, consisting in exclusive feeding with amino-acid based formulas, often~     administered trough SNG. Alternative choices of acceptable efficacy are empirical six-foods~     elimination diet (cow's milk, egg, soy, wheat, peanuts, fish) and targeted elimination diet~     based on the results of allergy tests. Most of the paediatric patients with EE respond to~     elemental or targeted elimination diets, and therefore such authors recommend elimination~     diets to be considered the treatment of choice in children. However, elimination diets can~     often be complex to follow and may be associated with poor adherence owing to the low~     palatability of a highly restricted diet. In non-compliant patients, especially in~     adolescents and young adults, it may be more practical to proceed first with corticosteroid~     treatment. In the case of partial response to elimination diets or corticosteroids, a~     combination of both treatment mod. However, there has been limited testing of these regimens~     in randomized controlled trials, while most of available literature is based on case series.~      The aim of this study was to compare the efficacy of six-foods elimination diet, swallowed~     fluticasone, swallowed budesonide and oral viscous budesonide (OVB) in pediatric patients~     with active EoE. The investigators assessed the effects of randomly assigned treatment on~     clinical and endoscopic/histologic severity as primary and secondary outcomes, respectively.~     The investigators describe clinical, allergological, endoscopic and histological features,~     and pH study results, of our pediatric population.~   "
131651|NCT01844128|"~     Obesity affects on fertility. Obese women have lower pregnancy rate after infertility~     treatments.They need more doses of hormone during ovarian stimulation, more days for~     stimulation. During IVF treatment less oocytes are collected and the quality of embryo also~     harmed.~      The first line treatment for those women with obesity and infertility is weight loss.~      The investigators' hypothesis is that weight reduction improves ovarian reserve and fertility~     treatment outcome.~   "
131435|NCT01846949|"~     This study is intended to be a prospective observational study at multiple sites, not a~     randomized controlled trial (RCT). The uses of the biomarkers has been approved by government~     regulations and adopted for surveillance programs in some countries, thus an RCT which~     compares patients followed by US alone with patients followed by both US and the biomarkers~     would raise an ethical conflict, especially in countries where the biomarkers have been~     routinely used.~      For this study, enrolled patients will be followed by US and the biomarkers at regular~     intervals and classified after completing the study to evaluate the clinical effectiveness of~     the biomarkers. The comparisons of sensitivity, specificity, and other parameters with~     respect to tumor characteristics will be made among US alone, the biomarkers, and combined~     use of US and the biomarkers. Also economical effectiveness of using the biomarkers will be~     investigated in this study.~   "
131436|NCT01846936|"~     One lung ventilation (OLV) is accomplished with a double lumen tube (DLT) or a bronchial~     blocker (BB). In this study, the investigators compared the effectiveness of lung collapse~     using DLT, BB with spontaneous collapse, and BB with disconnection technique.~   "
131437|NCT01846923|"~     The purpose of this study is to determine whether one dose of the 13-valent pneumococcal~     conjugate vaccine (PCV13) induces immunological memory in asplenic adults and whether~     previously administered immunizations with the 23-valent polysaccharide pneumococcal vaccine~     influence the cellular immune response to PCV13 in this group.~   "
131438|NCT01846910|"~     The objectives of this study are:~        1. To determine the effect that an intensive, community dental clinic centered,~          stop-smoking program using a motivational interviewing approach has upon cessation rates~          for interested, smoking inner-city dental patients.~        2. To determine the effect that providing a tooth whitening incentive, in a community~          dental clinic stop-smoking program, has upon cessation rates for interested, smoking~          inner-city dental patients.~   "
131439|NCT01846884|"~     To collect and process urine samples from critically ill subjects for use in assessing the~     effects of various urine sample freezing and storage conditions on biomarker test results.~   "
131440|NCT01846871|"~     This research study is a Phase II clinical trial, which tests the safety and effectiveness of~     an investigational drug to learn whether the drug works in treating a specific cancer.~     Investigational means that the study drug tivozanib is still being studied. It also means~     that the FDA has not yet approved tivozanib for your type of cancer.~      Tivozanib is an anti-angiogenesis medicine that fights different types of cancer by blocking~     the blood supply to the tumor, so that the tumor does not receive the nutrients it requires~     to grow.~      In this research study, we are looking to see what effects, good and bad, tivozanib will have~     on you and your disease.~   "
131441|NCT01846858|"~     Vaginal cuff dehiscence, a rare complication of gynecologic surgeries, can be devastating,~     particularly when associated with bowel evisceration. A review of records from 1970 - 2001 at~     the Mayo Clinic in Rochester, MN revealed a low incidence (0.032%) of vaginal cuff dehiscence~     after pelvic operation via both abdominal and vaginal approaches3. At a single, large,~     tertiary care facility, total laparoscopic hysterectomy (TLH) was associated with an~     increased incidence of vaginal cuff dehiscence compared to other approaches (4.93% vs. 0.29%~     TVH, and 0.12% TAH)1. A review of our robotic experience revealed a vaginal cuff dehiscence~     incidence of 4.1%, which is comparable to the previously reported incidence for TLH2. An~     increasing number of laparoscopic hysterectomies are being performed in the United States~     with the rate of laparoscopic procedures increasing from 0.3% in 1990 to 11.8% in 20034. With~     11.8% of 600,000 annual hysterectomies being performed via the laparoscopic route in the~     United States, there would be an estimated 3,400 cases of vaginal cuff dehiscence per year.~      The cause of the higher rate of vaginal cuff dehiscence in both laparoscopic and robotic~     hysterectomies is currently unknown. One of the major differences between the laparoscopic~     and robotic approach as compared to the vaginal/abdominal route is the method by which the~     cervix is amputated from the vagina. With the vaginal and abdominal approaches, a colpotomy~     is made sharply with a knife or scissors. In contrast, the colpotomy is performed with~     electrocoagulation with the laparoscopic and robotic routes. One theory to explain the~     increased dehiscence incidence is the lateral thermal effects of electrocoagulation on the~     vaginal cuff which may adversely affect tissue healing.~      This study aims primarily to shed light on the etiology of vaginal cuff healing after a~     robotic total hysterectomy. This will be done by comparing the extent of thermal injury at~     the cellular level using monopolar vs CO2 laser at the time of the colpotomy.~   "
131442|NCT01846845|"~     The purpose of the study is to evaluate residual limb circulation and skin health associated~     with the use of a novel prosthetic transfemoral socket system. A conventional prosthesis will~     be compared to the novel transfemoral socket system.~   "
131443|NCT01846832|"~     The purpose of this study is to evaluate the efficacy, tolerability, and safety of 12-weeks~     of treatment with TMC435 plus pegylated interferon alfa-2a (PegIFNα-2a) and ribavirin (RBV)~     in previously untreated adult participants with genotype 1 or genotype 4 chronic Hepatitis C~     Virus (HCV) infection.~   "
131444|NCT01846819|"~     100 ambulatory cirrhotic patients attending a liver transplant clinic will undergo a~     comprehensive clinical evaluation for severity of liver disease, anemia, depression, and~     fatigue. Fatigue will be assessed with the FIS and sub-maximal exercise capacity with the~     6-minute walk test (6MWT), a standardized exercise test that measures the distance that a~     patient is capable of walking in 6 minutes (6MWD). Depression will be assessed by using three~     well-known questionnaires. The SF-36, Beck's Depression Inventory (BDI-II), EQ-5D, and the~     Psychological General Well-Being Index (PGWBI). Univariate analysis will be performed to~     select the factors that potentially are associated with the scores as indicated by a P value~     <.20; the selected factors will then be entered in a stepwise regression to create a~     multivariate model giving the combination of factors that are significantly associated with~     the measure of fatigue and depression. Hemoglobin (Hb) levels will then be added to the model~     in order to test its significance while controlling for the other factors.~   "
131445|NCT01846806|"~     This is a prospective study designed to examine the role of bacterial overgrowth and delayed~     intestinal transit and the effect of Rifaximin with hepatic encephalopathy (HE). This study~     is divided into Phase A and Phase B. The purpose of Phase A is to test patients with~     cirrhosis to determine if they have bacterial overgrowth which may lead to slow intestinal~     transit and hepatic encephalopathy. The purpose of Phase B is to investigate whether the~     improvement found in patients with hepatic encephalopathy taking Rifaximin is also related to~     decreased bacterial overgrowth.~      Subjects' mental capacity will be assessed at each visit via interview, brief mental status,~     questionnaires and psychometric evaluation. Any subject who appears to have lost capacity to~     continue participation, as evidenced by HE grade 2 or higher, a lack of attentiveness,~     concentration, or understanding of evaluation, will be discontinued from the study. Female~     subjects of childbearing potential will be asked to comply with the use of contraception~     during the Phase B study period as well as throughout the time they remain on study drug.~   "
131449|NCT01846754|"~     The prevalence of end stage renal disease in Taiwan was listed first all over the world.~     Fatigue, which makes patients unable to be competitive to play their functional roles, is one~     of the most bothersome symptoms of patients receiving long-term hemodialysis. Tracing back to~     the development of its relating studies, there is no accurate reason that why does people~     undergoing hemodialysis feel fatigued. Conclusive predictors of fatigue are still not shown~     up yet. Paper review indicated that the level of L-Carnitine concentration, which affect~     metabolism of fatty acid, had correlation with fatigue and muscle strength in this~     population. The serum concentration of L-Carnitine is influenced a lot by hemodialysis. When~     there is deficiency of energy supply, it resulted to decline of muscle strength, which~     increased frequency and intensity of fatigue. Hence, the purposes of this study are (1) to~     understand the basic condition of fatigue level, muscle and metabolism of fat and~     carbohydrate among hemodialysis patients, (2) to analyze correlation among muscle strength,~     metabolism of fat/carbohydrate, and fatigue, and (3) to understand correlations among~     demographic characteristics, blood test data (hemoglobin, albumin, Kt/V, urea reduction~     ratio(URR), blood urea nitrogen(BUN), creatinine, calcium, phosphorus, and C-reactive~     protein), mental and social conditions (depression, anxiety, and social support), muscle~     strength and fatigue, seeking further exploring predictors of muscle strength and fatigue.~      The study use cross-sectional descriptive correlative design with consecutive sampling.~     Recruit patients from a hemodialysis unit in a medical center in north Taiwan after informed-~     consent. The estimated sample size is 100. To understand relationship among muscle strength,~     by-products of fatty acid and carbohydrate and fatigue, we collect data by measuring their~     muscle strength (handgrip and 30 seconds sit-to-stand), and analyzing blood test data and the~     structured questionnaires which included mental/social data (depression, anxiety, social~     support and fatigue level). Descriptive statistics, ANOVA, Pearson's correlation, Spearsman's~     rank correlation and stepwise regression were used to analyze the collected data. Hope this~     research can get advance in comprehension of cause of fatigue and improve the fatigue symptom~     of hemodialysis patients.~   "
131450|NCT01846741|"~     Obtain baseline clinical outcome data (Stage 1) upon which to base a subsequent study (Stage~     2) of the Model 106 VNS implantable pulse generator~   "
131451|NCT01846728|"~     Menopause is associated with weight gain, but the reasons why are not clear. In this study,~     the investigators will determine if reducing estrogen levels causes a decrease in the ability~     of the body to produce heat. If so, this would suggest this is one way that menopause may~     cause weight gain.~   "
131452|NCT01846715|"~     The primary purpose of this study is to assess the safety and optimal delivery of the~     Neo-Kidney Augment (NKA) when implanted at one site in a recipient kidney. NKA is made from~     expanded autologous, homologous, selected renal cells (SRC) obtained from the patient's~     kidney biopsy.~   "
131453|NCT01846702|"~     The main purpose of this study is to evaluate the safety and tolerability of the study drug~     known as LY3084077 in healthy participants. The study will also investigate how much of the~     study drug gets into the blood stream and how long it takes the body to get rid of it.~     Information about any side effects that may occur will also be collected. The study is~     expected to last approximately 8 weeks for each participant.~   "
131454|NCT01846689|"~     The objective of this study is to measure the change in blood values after the administration~     of an amino acid based erythropoietin stimulating system.~   "
131455|NCT01846676|"~     -  Introduction: Hearing loss is a prevalent condition in elderly population. However, the~          low adherence to hearing aids is a fact, with an estimation of use of 50 per cent. In~          2007 there was designed a rehabilitation program called ACE, which aims to improve~          rehabilitation directed to hearing aids users. The study hypothesis is that a counseling~          program will improve adherence to hearing aids in elderly population.~        -  Objective: To evaluate the utility of a standardized counselling program in patients~          with hearing loss.~        -  Material and Methods: A before/after trial will be carried out, approved by the Hospital~          ethics - committee. Patients with 65 years and older with hearing loss diagnosed by pure~          tone audiometry will be included. To assess adherence we will use the IOI-HA scale.~   "
131456|NCT01846663|"~     The purpose of the study is to evaluate the safety of Rifaximin or placebo in subjects with~     severe hepatic impairment and Hepatic Encephalopathy.~   "
131457|NCT01846650|"~     1. purpose: To conduct the relative bioavalability study of Capecitabine tablets 500 mg~          (Jiangsu Chia-Tai Tianqing Pharmacy Co. Ltd.) versus XELODA® 500 mg tablets~          (Manufactured by Roche Pharma AG)~        2. Experimental Design： Two-period crossover design~        3. Test drug: Capecitabine tablets Reference drug: XELODA~        4. Sample size：24~   "
131458|NCT01846637|"~     The investigators compare two techniques for laparoscopic sleeve gastrectomy. in the first~     one the distal margin of stapling is 2 cm from the pylorus and in the second it is 6 cm away~     from the pylorus.~   "
131459|NCT01846624|"~     This phase 2 study evaluates the sequential combination of decitabine then midostaurin for~     the treatment of newly-diagnosed acute myeloid leukemia (AML) in older patients.~   "
131460|NCT01846611|"~     The purpose of this study is to assess the efficacy and safety of trabectedin+DOXIL as a~     third-line chemotherapy regimen (treatment) in patients with platinum-sensitive~     advanced-relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer who~     received 2 previous lines of platinum-based chemotherapy.~   "
131461|NCT01846598|"~     Background and Purpose:The level of the surgical wound healing of the epidermis takes 6-12~     hours, and the peak period of 48 hours to achieve healing.The traditional postoperative wound~     care was every 1-3 days clean with saline and gauze or other dressing and not opened .In~     traditional concept the wound touch the water that will increase the rate of wound~     infection.England Department of Health in 2008 surgical wound care guidelines about surgery~     wound cleaning solution comparison. It was no significant difference in wound infection.with~     normalsaline and tap water. 2012 The Cochrane Collaboration: Water for wound cleansing~     systematic review of the literature that wound clean water has no effect on the rate of wound~     infection and healing rate, conducive to personal hygiene and cost-effective. Under high~     temperature and humid environments in our country, after surgery not bathe often affect~     patients' satisfaction and increase the cost of dressing and manpower, Was opened a line~     after surgery the wound can be shower? It is important about surgical wound care guidelines,~     but also the patient daily asked a high degree of issues. Purpose of this study (1)~     post-operative 48 hours, shower or not wound infection rate (2) post-operative 48 hours,~     shower or not the pain score (3) post-operative 48 hours, shower or not the comfortable (4)~     post-operative 48 hours, shower or not the care costs.~   "
131462|NCT01846585|"~     The aim of the study is to improve sleep during pregnancy and the postpartum period in women~     who are experiencing insomnia, using a brief non-pharmacological treatment.~   "
131463|NCT01846572|"~     The aim of this study was to determine the prevalence rate and risk factors for chemical~     laboratory clopidogrel low-response (CLR) in the acute phase after an ischemic stroke.~   "
131652|NCT01844115|"~     The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone~     relative to placebo in the treatment of generalized anxiety disorder (GAD).~   "
131464|NCT01846559|"~     Platelets are the main type of blood cell involved in the formation of blood clots that cause~     heart attacks. The investigators give antiplatelet drugs (aspirin, for example) to reduce the~     risk of another clot forming in the future and causing another heart attack. Platelets are~     known to have a role in inflammation and infection as well as clotting. In a recent large~     clinical trial, known as the PLATO study, it was also shown that patients treated with a new~     antiplatelet medication (ticagrelor) developed fewer lung infections, as well as fewer heart~     attacks, compared to the current standard treatment (clopidogrel). The investigators would~     therefore like to investigate the reasons behind this and look at the effect of these~     medications on immune response. This may help us develop new drugs that have a better effect~     on immune response. The investigators are planning a clinical trial that investigates the~     effect of these medications on the immune response of healthy volunteers aged 18 to 65.~      Only volunteers with no significant past medical history and not taking any medications will~     be included.~      Thirty volunteers will receive either a normal dose of ticagrelor or clopidogrel or no~     antiplatelet medication for 1 week.~      They will then attend the Sheffield Clinical Research Facility where their immune response~     will be stimulated using a safe, well established method. The investigators will do this with~     an injection of a low dose of endotoxin, which is part of the surface coating of some~     bacteria and has been used extensively in similar studies, in over a thousand volunteers over~     the past 20 years to investigate immune response. It is known to cause temporary flu-like~     symptoms that last approximately 68 hours. The investigators will take measurements of~     inflammatory markers, white blood cell function and platelet function and compare the effect~     of ticagrelor and clopidogrel on this immune response.~   "
131465|NCT01846546|"~     Angiogenesis is an important pathophysiological response to traumatic brain injury (TBI) and~     modulated by pro- and anti-angiogenic factors. Recent studies have suggested that endogenous~     angiogenesis inhibitor endostatin/collagen XVIII might play an important role in the~     secondary brain injury following TBI. The aim of this study was to investigate early changes~     in the concentrations of CSF endostatin/collagen XVIII after TBI and evaluated the relations~     of endostatin/collagen XVIII to injury severity and clinical outcome. Endostatin/collagen~     XVIII concentrations were measured serially for 1 week after hospitalization by using the~     enzyme linked immunosorbent assay method in the cerebrospinal fluid of 30 patients with TBI~     and a Glasgow Coma Scale score of 8 or less on admission. Comparative analysis were used to~     determine if its serial changes correlate with the GCS score and prognosis. Receiver~     operating characteristic curve was used to appraise the value of CSF endostatin/collagen~     XVIII levels in predicting the prognosis of patients with severe head injury.~   "
131466|NCT01846533|"~     Some possible humoural and cellular mechanism for diabetes related osteoporosis/fractures~     were proposed and summarzied as the following, (1)Diabetes mellitus increases osteoclast~     function but decreases osteoblast function, thereby leading to accelerated bone loss,~     osteopenia and osteoporosis. (2)DM/hyperglycemia induces production of macrophage colony~     stimulating factor (MCSF), tumor necrosis factor (TNF)-α and receptor activator of nuclear~     factor-κB ligand (RANKL), all of which are osteoblast-derived activators of osteoclast~     proliferation and differentiation. (3) DM/hyperglycemia suppresses osteoblast proliferation~     and function, in part, by decreasing runtrelated transcription factor (Runx)-2, osteocalcin~     and osteopontin expressions. (4)Adipogenic differentiation of mesenchymal stem cells is~     increased as indicated by the overexpression of adipocyte differentiation markers, including~     peroxisome proliferator-activated receptor (PPAR)-g, adipocyte fatty acid binding protein~     (aP2), adipsin and resistin. A decrease in neovascularization may further aggravate bone~     loss. (5)Bone quality is also reduced as a result of advanced glycation end products (AGE)~     production, which may eventually result in low impact or fragility fractures. DM are~     associated osteoporosis/fracture. The underlying mechanism, especially of type 2 DM, mandates~     a DM-osteoporosis cohort to elucidate. In clinical practice, to developed preventive~     strategies from osteoporotic-fracture is also necessary.~   "
131467|NCT01846520|"~     This randomized clinical trial studies the Family Caregiver Palliative Care Intervention in~     supporting caregivers of patients with stage II-IV gastrointestinal, gynecologic, urologic~     and lung cancers. Education and telephone counseling may reduce stress and improve the~     well-being and quality of life of caregivers of cancer patients.~   "
131468|NCT01846507|"~     This is a study to learn more about a drug called Tranexamic acid (TA), otherwise known as~     Lysteda, and whether or not this drug can decrease menstrual blood loss in young women and~     lead to an increase in the quality of life.~      Menorrhagia in young women with bleeding disorders is typically treated with a combination of~     treatments including hormonal contraceptives. However, there are barriers to hormonal~     contraception use in younger adolescents.~      Tranexamic acid is taken orally during the first 5 days of menstrual bleeding.~      The purposes of this study include:~      To test the safety and efficacy of Lysteda in adolescent females. To learn how well Lysteda~     works in decreasing menstrual blood loss. To see if parents and children participating in~     this study think the drug is improving their quality of life.~      Lysteda has been approved by the Food and Drug Administration for use in patients > than 18~     years of age but not for younger patients.~   "
131469|NCT01846494|"~     The purpose of this study is to monitor the cardiovascular and renal health of patients who~     previously took BMS-986094 (an investigational medication for hepatitis C) in comparison to~     hepatitis C infected patients who have never taken BMS-986094.~   "
131470|NCT01846481|"~     This is a randomized, 4-sequence, 2-period, double-blind, placebo controlled study in male~     and female subjects with an American Psychiatric Association Diagnostic and Statistical~     Manual DSM-IV-TR diagnosis of cocaine abuse.~   "
131471|NCT01846468|"~     The purpose of the study is to provide pertinent information to enable decisions regarding~     the developability of LHW090 for use in patients with chronic renal insufficiency, including~     a comparison of the potential risk-benefit ratio of several doses of the study drug to enable~     optimal doses to be tested in later studies.~   "
131472|NCT01846455|"~     The objective was to determine if hepatitis C virus (HCV) infection or mild to severe hepatic~     impairment (Child-Pugh Classes A, B, and C) altered the PK of buprenorphine,~     norbuprenorphine, or naloxone.~   "
131473|NCT01846442|"~     The purpose of this study is to determine the dose-response of vaginal mucosa parameters to~     the local action of DHEA (Dehydroepiandrosterone) in postmenopausal women suffering from~     vaginal atrophy.~   "
131474|NCT01846429|"~     The purpose of this study is to:~        -  Determine how well people tolerate sodium bicarbonate taken by mouth in higher doses~          than those usually given for heartburn.~        -  Determine if sodium bicarbonate can reduce cancer-related pain.~   "
131720|NCT01843231|"~     This study is a multi-center, open/unblended study (3:1Treatment: Control) to evaluate the~     safety and effectiveness of the g-Cath EZ Suture Anchor Delivery Catheter as an early weight~     loss intervention compared to a diet and exercise control only. Mean % Total Body Weight Loss~     [TBWL] in Treatment subjects versus that of Control subjects at 12 months is the primary~     endpoint. The proportion of subjects achieving ≥ 5% TBWL at 12 months in the treatment group~     is a co-primary endpoint.~   "
131475|NCT01846416|"~     This multicenter, single-arm study will evaluate the efficacy and safety of atezolizumab~     (MPDL3280A) in participants with PD-L1-positive locally advanced or metastatic NSCLC.~     Participants will receive an intravenous (IV) dose of 1200 milligrams (mg) atezolizumab~     (MPDL3280A) on Day 1 of 21-day cycles until disease progression.~      Eligible participants will be categorized in to three groups as follows:~        1. Participants with no prior chemotherapy for advanced disease;~        2. Participants who progress during or following a prior-platinum based chemotherapy~          regimen for advanced disease (2L+participants);~        3. Participants who are 2L+ and previously treated for brain metastases.~   "
131476|NCT01846403|"~     Given the potential of semi-quantitative pregnancy tests as part of assisted fertility care,~     we would like to document the feasibility and acceptability of a semi-quantitative pregnancy~     test as an adjunct to or replacement of current monitoring protocols to offer women and~     health care providers a new choice of diagnostic tools to confirm early pregnancy. The pilot~     will help us to better understand how this tool complements existing monitoring protocols. If~     a suitable addition, replacement to repeat blood draws for serum hCG assessment, the SQPT~     could also contribute to efforts to make assisted fertility treatments more patient-friendly.~     This study seeks to test this innovation by asking women assigned to perform a dBest®~     semi-quantitative urine panel test (AmeriTekInc, Seattle WA, USA)at home on a weekly basis~     for up to 4 weeks after embryo transfer.~      We hypothesize that the test, which can be used at home by women, will provide confirmation~     of the presence of a pregnancy compared with standard serum hCG testing because 1) it has~     sensitivity and specificity that correlates well with serum testing, and 2) it can be used at~     home and thus earlier to determine presence of hCG. Furthermore, a pregnancy can be assured~     only when a yolksac or embryo could be identified thus women have to wait for a period of 2-3~     weeks after the next menses expected.~      We hypothesize that women seeking assisted fertility treatments will be able to monitor their~     hCG at home as well. Further, we plan to develop revised instructions to better suit the~     needs and questions we think would be relevant to women desiring to use this test as part of~     assisted fertility services.~      We hypothesize that the simple instructions we will develop for use in this study will enable~     women to use the test on their own. Provider counseling will complement these instructions~     and contribute to overall quality of care given to each participant.~   "
131477|NCT01846390|"~     This research is being done because it is not yet known what dose of romidepsin in~     combination with gemcitabine, dexamethasone, and cisplatin (GDP) can be given safely to~     patients with peripheral T-cell lymphoma, nor what type and severity of side effects will~     result from the combination of these treatments. This research is also being done because it~     is not clear if the addition of the new drug romidepsin to treatment with GDP can offer~     better results and longer survival.~   "
131478|NCT01846377|"~     With the increasing rates of child obesity and diabetes, innovative programs are needed that~     capture children's attention and permit behavior change messages to get through. Serious~     video games with their immersive stories offer one such promising alternative due to their~     low cost approach to intervention since the games have already been developed, and can be~     broadly disseminated by simply reproducing and distributing their DVDs. While using video~     games for health promotion is controversial, this study will establish whether video games~     can effectively change diabetes and obesity risks (especially fasting insulin, diet and~     physical activity) among children.~      Escape from Diab and Nanoswarm: Invasion from Inner Space are two video games that~     targeted children to increase fruit, vegetable and water intakes, reduce sedentary behaviors~     (SB), and increase physical activity in a pilot study with a relatively low risk children. In~     light of this, it is important to test whether these games can help decrease diabetes (i.e.~     fasting insulin) and obesity risks with high risk (85%tile < BMI < 99%tile) 10 to 12 year old~     children.~      Children will be randomly assigned to treatment or control groups. The treatment group will~     play Diab and Nano over a 3-month time period. A wait-list control group will receive the~     Diab and Nano games at the end of their second post assessment (5-months post baseline~     assessment).~   "
131479|NCT01846364|"~     Diindolylmethane (DIM), a dietary supplement, found naturally in cruciferous vegetables (such~     as cabbage, cauliflower, broccoli, & Brussels sprouts) has been studied extensively in recent~     years for its anti-cancer effects. DIM has been shown to exert control over cancer cell~     growth in breast, uterine, cervical, ovarian, and colon cancer.~      To date no human study has been published regarding the bioavailability of DIM in thyroid~     tissue or its effects in proliferative thyroid disease. Our previous study attempted to~     elucidate DIM's promotion of anti-proliferative estrogen metabolites in proliferative thyroid~     disease and ascertain its uptake in thyroid tissue. DIM has been shown to concentrate in the~     thyroid gland. Furthermore, thyroid volumes have been seen to decrease subjectively.~      This study would continue our attempt to elucidate DIM's promotion of anti-proliferative~     estrogen metabolites in proliferative thyroid disease.~   "
131480|NCT01846351|"~     Study designed to evaluate the effect of significant ERM on the visual and anatomic outcomes~     of intravitreal anti-VEGF therapy for eAMD.~   "
131481|NCT01846338|"~     The aim of this study is to investigate the therapeutic effects of green tea extract on acne~     treatment and related hormone peptides by a double-blinded, randomized and controlled~     clinical trial.~   "
131482|NCT01846325|"~     Since docosahexaenoic acid (DHA) level in sperm membrane has been shown to be decreased in~     asthenozoospermic men, the investigators hypothesized that DHA supplementation may improve~     it. Furthermore, the investigators added vitamin E to it to protect its unsaturated bonds~     which are susceptible to oxidation and production of free oxygen radicals.~   "
131483|NCT01846312|"~     This study is conducted in the United States of America (USA). The aim of the study is to~     assess longitudinal variation of immune biomarkers in subjects at risk for development of~     type 1 diabetes (T1D).~   "
131484|NCT01846299|"~     To evaluate the efficacy and safety of 0.5 mg Ranibizumab intravitreal injections in adult~     patients with visual impairment due to macular edema (ME).~   "
131485|NCT01846286|"~     The goal of this research study is to learn more about chronic pain associated with cancer~     treatment.~   "
131486|NCT01846273|"~     This study will compare the effect of ranibizumab administered as monotherapy versus~     ranibizumab administered in combination with verteporfin PDT on visual acuity in patients~     with symptomatic macular PCV. The results of this study will provide long-term safety and~     efficacy data used to generate further guidance on the management of patients with PCV.~   "
131558|NCT01845337|"~     Capecitabine is a chemotherapy drug used to treat many types of cancer including bowel and~     stomach cancer. Unfortunately a side effect of this drug is that it causes heart problems~     including heart attacks. An alternative drug, called teysuno is used extensively in other~     countries instead of capecitabine and appears to have less of a bad effect on the heart~     whilst still killing cancer cells. This study will investigate the effect of these two drugs~     on the heart and blood vessels and will be the first of its kind in humans.~   "
131487|NCT01846260|"~     Cognitive impairment associated with chemotherapy is an important reported post-treatment~     side-effect among breast and other cancer survivors. As some patients report cognitive~     complaints before the administration of their therapy, some authors suggest an association~     with psychological risk factors such as distress. Distress, a multifactorial unpleasant~     emotional experience of a psychological (cognitive, behavioral and emotional), social and/or~     spiritual nature that may interfere with the ability to cope with cancer effectively, its~     physical symptoms and its treatment, can easily be assessed by the Distress Thermometer.~      In this trial we aim to determine if the Distress Thermometer, accompanied by the 38-item~     Problem List, could predict cancer-related cognitive impairment in patients with hematologic~     malignancies, and in patients with gynecological, urological, breast, lung or~     gastro-intestinal cancer receiving curative radiotherapy, chemotherapy, radiochemotherapy,~     anti-hormonal or targeted therapy.~   "
131488|NCT01846247|"~     Phase 3, multicenter, international randomized controlled trial of a Very Early~     Mobilization(VEM) care rehabilitation protocol compared to standard post stroke care (SC).~     Participants receive either SC and VEM or SC alone in the acute phase of stroke up to a~     period of 14 days.~      Participants are followed up by a blinded assessor at 3 and 12 months post stroke to~     determine trial outcomes.~   "
131489|NCT01846234|"~     Recently, it has been shown that salt (ClNa, sodium chloride) can modulate the~     differentiation of human and mouse TH17 cells. Indeed, mice feed with high sodium diet were~     described to develop more aggressive course of EAE (Experimental Autoimmune Encephalitis).~      However, the role of sodium intake in MS has not been investigated. In this study we~     investigate the effect of sodium intake in Multiple Sclerosis (MS) clinical and radiological~     activity.~   "
131490|NCT01846221|"~     Epidural analgesia has proven to be an effective method for severe pain relief associated~     with labor and delivery. During labor, a low dose continuous infusion of local anesthetic and~     narcotic will be administered through an epidural catheter. As labor progresses and the~     baby's head makes it way through the pelvis, breakthrough pain may emerge and often needs~     further treatment. The investigators provide pain relief by administering analgesics through~     the epidural catheter. The patients will be randomly assigned to receive one of two~     medication mixtures believed to be successful in treating this type of pain associated with~     advanced labor. After this initial treatment, if pain relief is not attained, the patient may~     receive the other medication as well. The medications used in this study have been used at~     this institution for some time and have been found to be safe for mother and baby. The opioid~     (fentanyl) dose is small and only a small fraction will be transmitted to the baby. The other~     medication (clonidine) better known as a blood pressure medication has also been used for~     pain relief. Studies and clinical experience have shown that clonidine when given epidurally~     in the doses used in this study has minimal, if any effect, on the blood pressure of the~     mother or of the baby. The investigators will record medical and obstetric history and labor~     progress relevant to the patient. The patient will be asked questions regarding labor pain~     and side effects before and after the analgesic is administered. The primary objective is to~     determine which treatment regimen is more successful in abolishing breakthrough pain in~     advanced labor.~   "
131491|NCT01846208|"~     The purpose of this study is to compare Baked Egg vs. Egg Oral Immunotherapy for inducing~     sustained unresponsiveness to egg exposure in children.~   "
131492|NCT01846195|"~     Non-invasive monitoring to measure changes in blood volume.~   "
131493|NCT01846182|"~     At least 1 in 4 of the 700,000 U.S. Veterans who served in the 1990-1991 Gulf War suffer from~     Gulf War Illness (GWI). Despite considerable research, effective treatments remain elusive.~     GWI refers to a complex of symptoms that typically include widespread chronic pain,~     persistent headache, memory and concentration problems, gastrointestinal difficulties, sleep~     disturbances and unexplained fatigue. These symptoms are similar to that of fibromyalgia~     syndrome (FMS), another multi-symptom condition. Whereas, effective treatments for GWI have~     yet to be found, the FDA has approved duloxetine and pregabalin for the treatment of FMS. The~     lack of progress in finding effective treatments for GWI, and the similarities between GWI~     and FMS, provides a rationale for determining if these medications can provide relief to~     Veterans who suffer from GWI. This randomized controlled trial will test the efficacy of~     Duloxetine and Pregabalin for treating Gulf War Veterans who suffer from GWI.~   "
131494|NCT01846169|"~     This application, funded by the American Association of Retired Persons(AARP) Foundation, is~     to implement the Healthy Eating for at Risk Older Adults (HERO) initiative. This initiative~     will address barriers of affordability, and reduced mobility by providing older adults with~     nutritious foods that are usually difficult to purchase due to high cost; delivering needed~     foods to individuals in their homes; tailoring food delivery frequency based on level of food~     insecurity; and offering basic nutrition education.~   "
131495|NCT01846156|"~     there is a standard magnesium sulphate protocol and newer protocols for pre-eclampsia, we~     need to make a trial to find the best protocol~   "
131496|NCT01846143|"~     The purpose of this study is to learn what effects (good and bad) experimental phosphopeptide~     vaccines plus a tetanus peptide and other substances called polyICLC and Montanide ISA-51~     have on people with melanoma. The investigators will also look at whether the experimental~     reagents cause any changes in the immune system.~   "
131497|NCT01846130|"~     The loss of muscle mass and function in older adults during bed rest is facilitated by~     defects in the regulation of muscle protein metabolism, including an impaired ability to~     mount an anabolic response to a mixed nutrient meal. The investigators propose that~     low-intensity exercise and supplementing daily meals with leucine or whey will independently~     and synergistically reduce the deleterious effects of inactivity on skeletal muscle and~     facilitate recovery during rehabilitation. Metabolic measures will include: a) nutrient and~     exercise-specific markers of translation initiation; b) skeletal muscle protein synthesis;~     and c) a novel breath test of glucose tolerance. Morphologic and functional measures will~     include: a) muscle mass and body composition; b) muscle strength and function; and c) motor~     activation. The investigators will test the following hypotheses in older men and women~     (65-80 years) during 7 days of bed rest followed by 7 days of inpatient rehabilitation:~        1. Inactivity-induced metabolic dysregulation will blunt the anabolic response to meals,~          facilitating a loss of lean muscle mass, glucose tolerance and functional capacity that~          is partially restored during rehabilitation.~        2. Supplementing daily meals with leucine or whey will maintain nutrient-stimulated~          translation initiation and preserve the anabolic response to meal ingestion. This will~          partially preserve lean muscle mass and function during bed rest and facilitate the~          recovery of functional and metabolic capacity during rehabilitation.~        3. Daily low-intensity exercise will preserve motor unit activation, stimulate the~          exercise-regulated signaling pathway and normalize the anabolic response to meal~          ingestion. This will partially preserve glucose tolerance, lean muscle mass and function~          during bed rest and facilitate rehabilitation.~        4. Leucine or whey-supplemented meals combined with low-intensity exercise will be a more~          effective stimulus than either intervention alone, preserving glucose tolerance, lean~          muscle mass and function during bed rest and facilitating a greater increase in~          functional and metabolic capacity during rehabilitation.~      This translational project will provide mechanistic and practical insight into strategies to~     reduce the negative consequences of physical inactivity and promote rehabilitation in aging~     muscle. Our novel, minimally invasive and clinically interventions have direct application~     for older hospitalized patients at risk of accelerated muscle loss and diminished functional~     capacity.~   "
131498|NCT01846117|"~     The investigators are investigating whether the flax lignan, secoisolariciresinol~     diglucoside, decreases oxidative stress and inflammation. The flax seed lignan is believed to~     be broken down in the body to produce the health benefits of flax. Flax lignan is separated~     from the whole flax seed as this compound is believed to have health effects. Decreasing~     oxidative stress and inflammation should improve a number of the problems associated with~     aging. This intervention consists of 600 milligrams of the flax lignan SDG daily or an~     equivalent amount of whey protein.~      The investigators are comparing lignan to a placebo (whey powder) to examine whether a~     dietary intervention (i.e. flax seed containing lignan) might decrease oxidative stress and~     inflammation.~   "
131499|NCT01846104|"~     The purpose of this study is to evaluate the safety and immunogenicity of a single 50-μg~     booster dose of RVEc. Subjects will be recruited from the cohort that received three 50-μg~     doses of RVEc in a Phase 1 trial (NCT01317667).~   "
131500|NCT01846091|"~     This phase I trial studies the side effects and the best dose of viral therapy in treating~     patients with squamous cell carcinoma of the head and neck that has returned (come back)~     after a period of improvement or has spread to other parts of the body or breast cancer that~     has spread to other parts of the body. A virus called encoding thyroidal sodium iodide~     symporter, which has been changed in a certain way, may be able to kill tumor cells without~     damaging normal cells.~   "
131501|NCT01846078|"~     Hypothesis: Holladay 2 formula is still accurate even used without lens thickness data.~   "
131502|NCT01846065|"~     Investigators have recently completed a pilot study exploring the safety and efficacy of~     using a virtual-reality based cue platform to elicit craving in smokers with~     schizophrenia(SWS)(Wehring et al, unpublished). In this study, participants with~     schizophrenia (n=16) showed increased attention to cigarettes and changes in craving measures~     when participating in the VR craving platform. In addition, participants tolerated the VR~     environment without undue adverse effects or exacerbation of symptoms. Adverse effects from~     the VR environment did not differ from that in a non-mentally ill population, and included~     headache, nausea, and dizziness as most commonly occurring factors. Persons in this pilot~     also showed acceptable rates of Immersion and Presence in the VR environment, showing the~     potential use of this form of environment for this and other purposes.~      In this study, investigators will examine virtual reality cue-reactivity in smokers with~     schizophrenia, with a focus on the relationship of cue-reactivity with self-identified~     triggers/cues. Smokers with schizophrenia often identify specific cues that trigger craving.~     Many of these are environmental (scent, sight of smoking paraphernalia or cigarettes, related~     objects, or social situations), however, a significant amount of smokers describe~     emotionally-based factors (sadness, being upset, etc.) as primary cues and triggers. Most~     methods used to elicit craving in experimental studies are executed via using environmental~     cues like sight of cigarettes or smoking paraphernalia. It is not known if smokers with~     schizophrenia(SWS) who are strongly emotionally triggered will be responsive to environmental~     triggers in a cue-elicited craving platform. This is an important research question, as the~     testing of anti-craving interventions should be generalizable for use across SWS with~     differing triggers to smoking. The VR-based environmental program from our pilot study, which~     includes sight, scent, and social cues, will be used to test pre-identified environmental~     cues/triggers and their effects on cue-elicited craving in 30 SWS. Subjective reports, mood~     and emotion measures, and objective physiological measurements will be used to identify and~     quantify environmental craving responsivity as well as tonic craving.~      Given the high prevalence of smoking among individuals with schizophrenia, understanding some~     of the environmental factors that serve to maintain nicotine dependence is a critical step in~     improving smoking cessation treatment outcomes. Establishing and validating a model of~     cue-elicited responsivity will allow future investigations of craving, and ultimately designs~     for studying the efficacy of anti-craving medications in people with schizophrenia.~   "
131503|NCT01846052|"~     The purpose of this study is to identify individuals with achromatopsia caused by mutations~     in the CNGB3 gene and characterize their clinical condition using several tests of visual~     function every 6 months for up to 1.5 years.~   "
131504|NCT01846039|"~     A prospective, open-label, observational study of the safety and efficacy of JUVÉDERM VOLUMA®~     to enhance the aesthetic appearance of the Asian nose.~   "
131505|NCT01846026|"~     Ulcerative colitis (UC) is an inflammatory disease involving the colonic mucosa, with~     bleedings and ulcerations. Consequences are destroyed mucosal barrier and increased~     permeability. Several cytokines are described to mediate the progressive course of ulcerative~     colitis and it is considered nowadays an immunologic disease. Patients with UC have often low~     levels of vitamin D and elevated prevalence of osteoporosis.~      In vitro studies demonstrate that vitamin D has an immunomodulating effect, and may have a~     direct healing action on colonic mucosa has been described in animal studies. One can~     therefore rise a hypothesis that vitamin D supplementation could be crucial in patients with~     UC. To our knowledge, it has not been performed randomized clinical trials to study these~     possible effects of vitamin D and it has not been studied the effects of vitamin D on the~     relapse frequency and immunological composition of colic mucosa in patient with moderate to~     severe ulcerative colitis.~      Objectives for our study are as follows: To examine if high-dose vitamin D supplementation in~     patients with moderate to severe ulcerative colitis:~        -  reduces relapse frequency and increase the duration of the Infliximab induced remission~        -  mediates and changes the cytokines composition in the colic mucosa~        -  decreases the excretion of calprotectin in feces and reduces the concentration of~          inflammation markers~        -  augments bone mass~   "
131506|NCT01846013|"~     Purpose:~      The purpose of this study is to implement and evaluate a randomized controlled trial in~     sitting office workers to reduce sitting time through the use of motorized and non-motorized~     sit/stand workstations as well as a walking intervention.~      Hypotheses:~        1. Compared to the control group, total physical activity will be higher in the standing~          and walking intervention groups.~        2. The combined standing and walking group will have higher total physical activity than~          the other three groups.~        3. Compared to the control group, the fitness and health outcomes will be improved for the~          standing and walking groups.~   "
131507|NCT01846000|"~     The purpose of this study is to assess the effect of low-level laser on pain, occlusal~     contacts, mandibular movements and electromyography activity in the masseter and temporal~     muscles in adolescents with TMD.~   "
131508|NCT01845987|"~     The purpose of this study is to assess the efficacy, safety, and tolerability of CNTO 1959~     following subcutaneous administration in participants with palmoplantar pustulosis.~   "
131509|NCT01845974|"~     This study examined data elements of hemodynamic, electrophysiologic and electrolyte trends~     comparing 2 different types of catheters used during a procedure to treat medication~     resistant atrial fibrillation-radiofrequency catheter ablation. A high flow catheter delivers~     a high volume of saline during the procedure. The low flow catheter delivers a low volume of~     saline during the procedure. The patient will be consented and randomized to one of the 2~     groups using a computer generated randomization chart. Those that are put in the low flow~     catheter group will be considered the experimental group. All data will be collected before~     and after the procedure and each patient will act as their own control within each group.~   "
131721|NCT01843218|"~     Erectile dysfunction will be explored by recording R / P and self-administered questionnaire~     IIEF-5.~   "
131511|NCT01845948|"~     This study tested the effectiveness of a parental training programme to enhance parent-child~     relationship and reduce harsh parenting practices and parental stress in the preparation of~     children for transition to primary school. A randomized controlled trial was employed and 142~     parents were recruited. Parents in the experimental group engaged in less harsh parenting~     practices and reported better parent-child relationships than parents in the control group.~     Findings from this study provide empirical evidence of the effectiveness of the parental~     training programme and highlight the significance of parental involvement in promoting a~     smooth transition for children from kindergarten to primary one.~   "
131512|NCT01845935|"~     To now, two alternatives for the management of venous vascular malformations are recognized,~     appropriate to the location, size and patients: sclerosis and surgery. However, sclerosis is~     effective on symptoms in 80% of cases and excision removes the malformation completely or~     partially, but it is aggressive and recurrences are common.~   "
131513|NCT01845922|"~     The study is based on a master thesis which showed that 72% of patients with head and neck~     cancer admitted to a Danish hospital (Rigshospitalet, Copenhagen) developed refeeding~     syndrome after admission.~      Refeeding syndrome is characterized by a decrease in plasma phosphate levels, which develops~     after the reintroduction of an adequate food intake after a longer period of starvation or~     semi-starvation. This normally happens within 7 days after reintroduction of food.~      The aim of this study is to minimize the incidence of refeeding syndrome in this group of~     patients by reintroducing food slowly and by providing a diet low in sodium and high in~     slowly absorbed carbohydrates as a prevention diet (i.e. given before a potential decrease in~     plasma phosphate levels appear). Both patients that eat normally, patients with eating tubes~     and patients with central vein catheters are included in the study, but the data will be~     evaluated both together and separately.~   "
131514|NCT01845909|"~     The investigators have created a way of quickly collecting information in a large scale young~     population regarding the presence of some severity indicators that may allow us to classify~     them into: seemingly low risk and possible elevated risk for the presence of heart~     disease. It would have to be a short questionnaire, in order to receive a great adherence but~     that could simultaneously provide precise information, with an adequate description of~     symptoms and warning signs, in a way that a triage in the young adult population could be~     performed in the general young adult population in order to select individuals with an~     indication for personalized clinical evaluation and possible need of complementary diagnostic~     means. Based on this premise the investigators have developed a fast-response questionnaire~     named the Sudden Cardiac Death Screening Of risk factorS (SCD-SOS). This questionnaire has~     already been tested in a population of approximately 1500 young adults, and some changes have~     been introduced in order to refine its performance.~      To best of the investigators knowledge, there are no large scale European surveys estimating~     the prevalence of cardiac disease and associated clinical symptoms in a non-selected~     (non-athlete) population of this age group.~      Purpose: To screen a young adult population from central regional of Portugal for heart~     disease possibly associated to a high risk of Sudden Cardiac Death (SCD).~      To determine the national prevalence of clinical symptoms of heart disease and of heart~     disease with increased risk for SCD in this age group.~      To detect young adults in risk of SCD and with an indication for evaluation by a~     cardiologist, and possible need of:~        -  medical treatment~        -  electrophysiologic (EP) study and percutaneous ablation~        -  an implantable cardiovertor defibrillator~        -  a pacemaker~        -  other type of specialized cardiac intervention~   "
131515|NCT01845896|"~     The purpose of this study is to investigate the effects of a combined training programme and~     a high intensity interval training programme on insulin resistance, muscle strength/ muscle~     contractile properties, aerobic capacity and body composition in MS patients.~      It is assumed that the the above mentioned clinical parameters will improve due to physical~     exercise.~   "
131516|NCT01845883|"~     In this proposal the investigators have three Specific Aims using human patient populations~     as model systems; 1) identify a role for the Basal Ganglia (BG) in perceptual decision~     making; 2) determine whether the Basal Ganglia contribute to decision making under conditions~     of visual uncertainty; 3) determine whether the cerebellum plays a role in perceptual~     decision-making under conditions of visual uncertainty. The investigators designed~     experiments using healthy humans and humans with diseases known to affect the Basal Ganglia~     and the cerebellum, Parkinson's Disease, dystonia and non-dystonic cerebellar damage. With~     this approach the investigators will test the following hypotheses: 1) Patients with~     Parkinson's Disease and dystonia will have more difficulty than healthy controls making~     perceptual decisions when faced with sensory uncertainty; when sensory information is~     certain, patients will show improved decision-making but will still be impaired relative to~     healthy humans. Hypothesis 2: If ambiguous sensory information is aided by prior information,~     patients with Parkinson's Disease and dystonia will be unable to use the prior (bias/memory)~     information to inform their decisions. Hypothesis 3: Deep Brain Stimulation (DBS) of Basal~     Ganglia structures will improve the ability of patients to use prior information to inform~     their decisions when faced with sensory uncertainty. Hypothesis 4: Both cholinergic and~     dopaminergic medical therapies will improve the ability of patients to use prior information~     to inform their decisions. Hypothesis 5: Patients with non-dystonic cerebellar damage will be~     similar to healthy controls in performance of a perceptual decision making task in conditions~     of visual uncertainty. The overarching framework of this application is that the same~     mechanisms (D1 striatal synaptic plasticity) that operate in reward learning play a role in~     learning and using stimulus priors in a perceptual decision-making task when faced with~     uncertainty. Because Parkinson's Disease and dystonia share deficits in striatal circuitry,~     the patient deficits on this task will be similar. Because non-dystonic cerebellar patients~     do not have dysfunction of striatal circuits, they will show no deficits in the ability to~     use stimulus priors to guide choices in uncertain conditions. In the event these patients do~     show deficits, this is will provide evidence for an unexplored role for the cerebellum in~     perceptual decision-making.~   "
131517|NCT01845870|"~     Diabetic nephropathy(DN)is a major microvascular complication of diabetes.Renal injury may be~     presented with the characteristics of albuminuria, and its main pathological change is~     glomerular sclerosis. However, both glomerular lesions such as glomerulosclerosis, glomerular~     basement membrane thickness and tubulointerstitial fibrosis have been found in both type 1~     and type 2 diabetic patients with normal urinary albumin excretion rate, moreover the tubular~     injury may be the primary pathological change in diabetic renal injury not only the secondary~     change brought on by glomerular injury. Thus, if overt urinary albumin exists in T2DM~     patients, the tubular injury may be severe already. An index which is predominant, sensitive~     and convenient to be measured should be purposed.It is predicted that insufficient renal~     1-alpha hydroxylase may play a critical role in diabetic nephropathy. Then the investigators~     present the presumption that the activity of renal 1-alpha hydroxylase could reflect the~     degrees of tubulointerstitial injury, using serum 1,25-dihydroxyvitamin D level as an index.~   "
131518|NCT01845857|"~     This survey will address important research, practice, and policy questions: How does Chronic~     Disease Self-Management Program (CDSMP) impact participants' general health, their health~     behaviors, and their need for health care utilization? Who benefits most from the CDSMP~     program? Are predicted gains maintained over a six and twelve month period? Can critical~     clinical changes be seen for those who are diabetic?~   "
131519|NCT01845844|"~     This is an open-label, Phase I/II study of Intravitreally administered 0.3mg ranibizumab in~     subjects with persistent Diabetic Macular Edema (DME) after recent and frequent bevacizumab~     (at least 2 bevacizumab intravitreal injections within 2 months prior to enrollment and at~     least 6 bevacizumab injections within 9 months of enrollment).~   "
131559|NCT01845324|"~     The investigators asume that the measurement of the fetal heart interventricular septum can~     serve as a good tool to predict glucose control in pregnant patients with diabetes mellitus.~     The investigators will measure the septum width in patients with Diabetes and will correlate~     to standard measurements of the glucuse levels.~   "
131520|NCT01845831|"~     High blood glucose levels in hospitalized patients with diabetes are associated with~     increased risk of medical complications and death. Improved glucose control with insulin~     injections may improve clinical outcome and prevent some of the hospital complications.~     Glargine (Lantus®) insulin injection is the most common treatment of diabetes in the~     hospital. Sitagliptin (Januvia®)is effective in lowering blood glucose. In a recent pilot~     study aiming to determine differences in glycemic control between treatment with sitagliptin~     (Januvia®) alone or in combination with basal insulin and basal bolus regimen in general~     medicine and surgery patients with type 2 diabetes (T2D). The investigators found that~     treatment with sitagliptin alone or in combination with basal insulin resulted in similar~     glycemic control compared to basal bolus regimen.~      The investigators will conduct a prospective RCT aimed to determine the safety and efficacy~     of sitagliptin therapy for in-hospital and post-discharge management of general medicine and~     surgical patients with T2D. A total of 280 patients with known history of diabetes will be~     randomized to receive sitagliptin plus basal (glargine) insulin once daily (group 1), or~     basal bolus regimen with glargine once daily and aspart or lispro insulin before meals (group~     2). If needed, patients in the treatment groups will receive correction doses of rapid-acting~     insulin in the presence of hyperglycemia (BG > 140 mg/dl). The overall hypothesis is that~     treatment with sitagliptin in combination with basal insulin in patients with type 2 diabetes~     will result in a similar improvement in hospital and post-discharge glycemic control and in a~     lower frequency of hypoglycemic events than treatment with basal bolus insulin regimen with~     glargine once daily and lispro insulin before meals.~      Patients will be recruited at Grady Memorial Hospital, Emory University Hospital, University~     of Michigan, Ohio State University and Temple University~   "
131521|NCT01845818|"~     This observational study will document to what extend in daily clinical practice the work~     productivity is affected before and after the start of adalimumab treatment.~      Changes in the employment status and work productivity of patients with AS and PsA before and~     after the start of Adalimumab will be noted. The relationship between employment status, work~     productivity, disease activity and clinical evaluations will be evaluated. Since AS and PsA~     might be very invalidating diseases with a strong impact on the daily life of the patient, an~     evaluation will be performed to the effect of the disease on Quality of Life and work~     productivity.~   "
131522|NCT01845805|"~     To improve progression free survival in high risk patients with resected pancreatic~     adenocarcinoma who have node positive disease, margin positive disease, and/or elevation in~     CA 19-9 treated with CC-486 (oral azacitidine) as compared to observation after completion of~     adjuvant therapy.~   "
131523|NCT01845792|"~     Patients are being asked to take place in this research study because they have advanced~     prostate cancer that has gotten worse after other treatments. If they join this study they~     will receive a new combination of drugs that are used to treat prostate cancer.~   "
131524|NCT01845779|"~     Complete response is a rare event in metastatic anal cancer in the case of unresectable~     recurrence after radiochemotherapy.~      In the University Hospital Center of Besançon, 8 patients with metastatic anal cancer were~     treated between 2005 and 2008 by 6 cycles of chemotherapy including taxane: DCF (Docetaxel,~     Cisplatin and 5-Fluorouracil.~      In more than 90% of cases, anal cancers are related to Human Papilloma Virus (HPV) infection,~     that is the case of this patients for which HPV16 (human papillomavirus type 16) genotype was~     identified within the tumor samples.~      The hypothesis is that an anti-HPV response immune could be generated by chemotherapy with~     DCF and contributed to the elimination of the tumour cells and to the increase of complete~     responses. The aim to this study is to analyze immune response against HPV in this patients~     in complete response.~   "
131525|NCT01845766|"~     We hypothesized that early exercise rehabilitation for patients with severe sepsis or septic~     shock would decrease their functional disability and cognitive impairment. We plan to enroll~     patients with severe sepsis and septic shock who admitted an urban teaching hospital in~     Seoul, South Korea via ER. We will randomize those subjects into the intervention group which~     will take a standardized rehabilitation with routine clinical care for sepsis and the control~     group which will take routine clinical care for sepsis. And, we plan to assess their~     functional activity using ADL, IADL and SF-36, and cognitive function using MMSE at the time~     of enrollment, 28 days, and 6 months later.~   "
131526|NCT01845753|"~     A clinically applicably strategy for molecular screening for Lynch Syndrome is being~     implemented in Denmark.~      Based on sequential analysis with immunohistochemistry and methylation analysis, patients~     with possible hereditary colorectal cancer are identified. These patients are offered genetic~     risk assessment and counselling.~      The study hypothesis is that molecular screening will identify more patients with Lynch~     Syndrome than the family history alone.~      Prospective data collection is performed using established clinical databases.~   "
131527|NCT01845740|"~     Milatuzumab will be given subcutaneously at different dose levels once (depending on the dose~     level) for 4 weeks to determine if milatuzumab helps to control lupus (SLE).~   "
131528|NCT01845727|"~     The proposed study encompasses a two-step approach. The first aiming to determine the safety~     of Topical 3% Amphotericin B Cream when applied three or two times per day for 4 weeks in~     subjects with un-complicated Cutaneous leishmaniasis (CL) whilst the second focusing in~     having and indication of the efficacy of the two above mentioned regimens of Topical 3%~     Amphotericin B Cream~      For the first step, 30 subjects will be randomly assigned to receive direct observed~     treatment (DOT) with Topical 3% Amphotericin B Cream applied either three or two times per~     day for 4 weeks. Enrolment will be temporarily halted until all 30 subjects (15 in each~     group) have been enrolled and completed the 28 day treatment course. An interim analysis of~     all safety (Adverse Events, including local reactions and lab parameters) and~     pharmacokinetics collected on subjects who were randomized will be performed by data safety~     monitoring board. If no serious adverse events (SAEs) related to the study drug are~     identified on the first 30 subjects by the end of the treatment course, 50 additional~     subjects will be randomly allocated to receive Topical 3% Amphotericin B Cream either three~     or two times per day for 28 days~      Subjects will have a follow-up visit at the end of therapy, on Day 45± 5 days, Day 63± 5 days~     and on Days 90± 14 days and on Day 180, minus 14d, plus 4 weeks to assess efficacy, as~     measured by the number of subjects who fulfil the cure criteria: 100% re-epithelialization of~     the lesion(s) by Day 90 and no relapse by Day 180. All subjects will be followed up to Day~     180 for final analysis of efficacy.~   "
131529|NCT01845714|"~     Study Hypothesis: Former investigators indicated that keratoconus has a negative impact on~     vision-specific quality of life. This study attempts to confirm this statement and assess~     whether cross-linking and cross-linking combined with photorefractive keratectomy improve~     vision-specific quality of life, in a sample of keratoconus patients with 3-years follow-up.~   "
131560|NCT01845311|"~     The RESTORE II clinical trial is intended to assess safety and performance of the ReZolve2~     Bioresorbable Coronary Scaffold in native coronary arteries.~   "
131733|NCT01843062|"~     The study is designed to evaluate the clinical efficacy, safety and tolerability of~     selumetinib with radioactive iodine therapy in patients with differentiated thyroid cancer.~   "
131530|NCT01845701|"~     To assess the efficacy of artesunate-amodiaquine, dihydroartemisinin-piperaquine, in~     comparison with artemether-lumefantrine during 42 days follow up period in 720 children with~     acute uncomplicated P. falciparum malaria, in two different endemic ecological areas -~     Savanna and equatorial forest regions of Cameroon.~      We have set as specific objectives:~        -  To assess the efficacy of artesunate-amodiaquine, dihydroartemisinin-piperaquine, in~          comparison with artemether-lumefantrine during 14 and 28 days follow up period in~          children with acute uncomplicated P. falciparum malaria in two different endemic areas.~        -  To evaluate the safety of artesunate-amodiaquine, dihydroartemisinin-piperaquine, in~          comparison with artemether-lumefantrine during 42 days follow up period in children with~          acute uncomplicated P. falciparum malaria.~        -  To determine parasite clearance time (PCT) and fever clearance time (FCT) following the~          administration of the three trial regimens.~        -  To investigate the treatment response based on WHO criteria (WHO, 2003) in patients in~          all groups after trial.~        -  To investigate the Single Nucleotide Polymorphisms (SNPs) and microsatellite markers of~          genes associated with drug resistance~   "
131531|NCT01845688|"~     The purpose of this study is to evaluate the clinical safety and efficacy of QingReMoShen~     Granule to treat idiopathic membranous nephropathy.~   "
131532|NCT01845675|"~     Temozolomide or dacarbazine-based chemotherapy combined with endostatin have efficacy in~     well-differentiated pancreatic neuroendocrine tumor~   "
131533|NCT01845662|"~     Purpose: Non-traumatic rupture of the spleen should be suspected when patients (especially~     young men) present with abdominal pain and a history of acute infectious or~     myeloproliferative disorders. Preoperative imaging studies in hemodynamically stable patients~     may obviate the need for surgery even in the presence of massive hemoperitoneum. The purpose~     of this research is to inform acute management where spontaneous rupture is suspected in~     order to avoid surgery where appropriate, rationalise angiographic intervention and blood~     transfusion.~      Hypothesis: Indentifying the cause of injuries can help target preventative intervention.~      Background: Non-traumatic rupture of the spleen is a rare condition. It may occur in the~     diseased spleen secondary to a variety of pathologies including malaria and~     myeloproliferative disorders. In some cases rupture may occur in an apparently normal spleen.~     The incidence, symptoms, causes, therapy and prognosis are poorly defined. The investigators,~     therefore, propose an extension of retrospective analysis conducted, presented and published~     in 2003 to examine all the cases of non-traumatic splenic rupture treated at Ziv Medical~     Centre from the last 26 years to present.~      Methods: Analysis of the medical notes of all patients with spontaneous splenic rupture in~     the medical archives.~      The investigators hope to determine the true incidence of this condition within the local~     population, increasingly diverse in origin, travel and the incidence of predisposing~     infectious disease; and to devise a practical protocol in their safe diagnosis and~     management, especially as non-operative interventions have grown in safety and effectiveness.~      Discussion: Although rare, spontaneous splenic rupture may be fatal if not suspected or~     treated inappropriately. Understanding the pitfalls in diagnosis and management better~     informs decision making towards improved care of these patients.~   "
131534|NCT01845649|"~     The purpose of the study is to determine if WC3011 is safe and effective in treating the~     symptom of painful intercourse secondary to vulvovaginal atrophy as measured by subject~     self-assessment when compared to vehicle.~   "
131535|NCT01845636|"~     Odor identification deficits, which are a result of early Alzheimer's Disease (AD) pathology~     in the olfactory bulb and tract as well as olfactory projection areas in the medial temporal~     lobe (entorhinal and piriform cortex and hippocampus), lateral and central orbitofrontal~     cortex and several other regions, occur in AD and strongly predict mild cognitive impairment~     (MCI) conversion to AD. Our pilot data, along with converging findings in the literature,~     suggests that odor identification deficits, both incremental change over time and change in~     response to an anticholinergic challenge, may be clinically simple, relatively inexpensive,~     predictors of cognitive improvement with acetylcholinesterase inhibitor (ACheI) treatment~     with potential clinical implications for predicting improvement and monitoring ACheI therapy.~   "
131536|NCT01845623|"~     This study will assess the pharmacodynamics, safety, tolerability and pharmacokinetics of~     indacaterol maleate (QAB149), administered via the EPIC test fixture. The study aims to~     determine whether the novel device has a similar clinical profile as the established concept~     1 device.~   "
131537|NCT01845610|"~     Complementary food supplements (CFS), fortified products that are mixed with the infant's~     usual complementary foods, have the potential to improve nutrition among infants. In Africa,~     maize is a major staple food used for complementary feeding. Compared to rice or wheat, maize~     has higher levels of phytates, which bind trace elements such as iron and zinc, and inhibit~     their absorption. The impact of CFS products in the context of a maize-based diet has not~     been well investigated. This study will test two newly developed fat-based CFS products made~     from soy.~      The first product is a fortified fat-based spread that contains essential fatty acids with~     added docosahexaenoic acid (DHA) and arachidonic acid (ARA), and phytase to improve iron and~     zinc bioavailability. The second product is a fortified fat-based product containing~     essential fatty acids. Both products contain soy. The enrichment of the products with~     essential fatty acids is of particular interest in the South African context, as consumers~     are exposed to higher linoleic acid (LA) diets due to the inclusion of mostly high~     LA-containing sunflower oil during food preparation. The CFS products could contribute~     towards restoring the balance between LA and alpha-linolenic acid (ALA) intake.~      The results of this study will provide evidence on whether or not two types of fortified CFS~     have the potential to address malnutrition (linear growth) and improve psychomotor~     development in infants. If proven effective, this approach of providing multiple nutrients~     can be made available to infants in the developing world and may lead to sustainable actions.~   "
131538|NCT01845597|"~     The purpose of this study is to determine the survivorship rate of robotic assisted medial~     partial knee replacement at a two, five, and ten years.~   "
131539|NCT01845584|"~     Patients diagnosed with anti-aquaporin 4 antibody positive Neuromyelitis Optica spectrum~     disorder were confirmed based on diagnostic criteria. Patients who meet all inclusion~     criteria and do not conflict with the exclusion criteria will receive steroid plus therapy~     （1g/day for five consecutive days）. Subsequently, patients who not provided adequate effect~     of therapy to steroids plus therapy will receive NPB-01 (intravenous immunoglobulin)~     400mg/kg/day for five consecutive days. Patients evaluated Quantification of nerve and spinal~     cord impairment （QOSI） and the Expanded Disability Status Scale （EDSS）/ Functional Systems~     （FS） and anti-aquaporin 4 antibody et al.~      As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse~     events by one year after the start of the study treatment.~   "
131600|NCT01844791|"~     The purpose of this study is to investigate the safety and efficacy of the use of OCZ103-OS~     in combination with Platinum-Gemcitabine based doublet first line therapy in stage IV~     non-small cell lung cancer (NSCLC) patients.~   "
131540|NCT01845571|"~     Background:~      Rhegmatogenous retinal detachment is an ophthalmic emergency that, without surgical repair,~     often leads to blindness. The incidence is about 1/10000/year. The leading causes are myopia~     and aging which cause retinal tears often resulting in retinal detachment. Patients commonly~     experience photopsia, floaters, and peripheral visual field loss.~      Two different general surgical treatment options exist for retinal detachment; scleral~     buckling or vitrectomy. However, the precise indications for each approach have not been well~     established. Correct classification of the retinal detachment is important. The first step is~     to decide whether an intra- or extra-ocular surgical approach is more appropriate. Simple~     rhegmatogenous retinal detachments are usually treated extraocularly with scleral buckling~     surgery, whereas more complicated cases require intraocular primary pars plana vitrectomy and~     one or more of gas, silicone oil, laser therapy, or cryotherapy.~      Study objectives:~      The purpose of this study is to evaluate different surgical techniques for the treatment of~     retinal detachment. Data relating to retinal status before treatment, surgical treatment,~     post-operative anatomy and visual acuity, post-operative OCT, and intra- and post-operative~     complications will be collected.~      Vitreous cytokines will also be analyzed to monitor intravitreal inflammation as a result of~     retinal detachment.~   "
131541|NCT01845558|"~     The aim of the current study is to investigate the therapeutic effect and especially the mode~     of action of Wobenzym® plus, an anti-inflammatory drug containing proteolytic enzymes, on~     exercise induced muscle damage (eiMD) and recovery time in male amateur sportsmen with medium~     proficiency level compared to placebo.~   "
131542|NCT01845545|"~     Investigators propose a feasibility and pilot study for a cluster randomised controlled~     trial. The proposed trial will evaluate the effects of an economic intervention~     (microfinance) in self-help groups of poor and marginalised women in three provinces in~     northern India, upon the health of these communities, with a focus on children under five~     years. This feasibility and pilot study will determine whether accurate data can be collected~     on mortality by means of a house to house survey or from the register of births and deaths.~     The feasibility stage will also determine whether village volunteers can accurately weigh~     children under five and record their weights alongside the financial data already recorded by~     the self-help group. If these data are accurate and can be collected reliably, the~     investigators will calculate the power and sample size needed for a future cluster randomised~     trial, as well as analysing preliminary results from the current project. The investigators~     will evaluate health outcomes, relating to two Millennium Development Goals: number of~     children under five years of age who are underweight and the under five mortality rate.~   "
131543|NCT01845532|"~     Laparoscopic operative procedures have revolutionized gynecological surgery. These have~     several advantages: a smaller and more cosmetic incision, reduced blood loss and shorter~     postoperative stay, which cuts down on hospital costs. However, postoperative pain continues~     to be one complication, which results in an unpleasant experience for the patient and at~     times causes a delayed discharge. Trigger point injection removes the pain developing point~     and block the pain signal. EMLA cream shows analgesic effect when being spread on the skin.~     An literature showed that patch of local anesthetics showed the effect of trigger point~     inject. The purpose of this study is to investigate the alleviation of shoulder pain,~     headache, abdominal pain, and back pain after trigger point injection or EMLA cream applying~     on shoulder in patients undergoing total laparoscopic hysterectomy.~   "
131544|NCT01845519|"~     This study aims to recruit post-treatment breast cancer survivors for a 12-week 2-arm~     randomized walking intervention. All intervention materials will be delivered electronically.~      The investigators hypothesize that at the end of 12-weeks, participants randomized to the~     intervention group will engage in more weekly steps than those participants randomized to the~     comparison group.~   "
131545|NCT01845506|"~     The primary outcome for this project will be the development of a small, non-invasive~     wireless sensor that is linked to a conventional computer that can be used in health care for~     monitoring of acute and chronic health problems. The advantages of developing this technology~     are threefold. First, monitoring can be conducted for a fraction of the cost of a bedside~     nurse. Second, monitoring can be done in real time and stored so that we can diagnose and~     manage critical events in a more timely manner. Lastly, many patients can be monitored~     simultaneously. The wireless sensors will be fitted to healthy volunteers of various ages.~     The data gathered from the sensor with respect to their vital signs will be compared to that~     of conventional tools such as nursing assessments and pulse oximetry.~   "
131546|NCT01845493|"~     The investigators will perform a pilot study of daily treatment with oral sulforaphane (SFN)~     for 3 days to determine if Nuclear factor (erythroid-derived 2)-like 2 (NRF2) induction is~     possible with this supplementation regimen in individuals with allergic asthma.~   "
131547|NCT01845480|"~     Female children (aged 8-13 years) will be recruited through posted flyers, newspaper ads, and~     word of mouth in the Manhattan, KS area. After laboratory assessment, recruited participants~     will be randomly assigned to either healthful eating and physical activity skills coaching or~     general health education coaching intervention conditions. For both conditions, research~     assistants will serve as wellness coaches and deliver 12 intervention sessions in the home of~     each participating child.~      Assessments will be completed at baseline, intervention end (3 months), and follow-up (6~     months), comprising biomedical and psychosocial measures. Biomedical measurements to be~     obtained include:~        -  body composition (DEXA, tetrapolar bioimpedance, body mass index, waist circumference)~        -  blood pressure (automated sphygmomanometer),~        -  pulmonary function tests (forced expiratory flow in 1-sec, forced vital capacity, forced~          expiratory flow at 25-75% of vital capacity),~        -  unstimulated whole (mixed) saliva passive drool to detect markers of inflammation,~        -  and physical activity levels (7-day accelerometry).~      Psychosocial measurements include:~        -  fruit and vegetable consumption (Child Dietary Questionnaire)~        -  self efficacy,~        -  enjoyment~        -  quality of life (Peds QL).~      Inclusion criteria are:~        -  being female~        -  aged 8-13 years~        -  with parental consent,~        -  residing within a 40-minute drive~        -  being available for 12 home coaching visits and three lab assessments.~      Exclusion criteria are~        -  having developmental delay or psychiatric problems,~        -  any illness, injury, condition, or disease that would prevent participation in~          moderate-to-vigorous physical activity,~        -  taking weight-altering medications~        -  participating in any other health behavior change program.~      The objectives of this study are to determine~        -  whether both types of the home-based coaching interventions are feasible~        -  whether the healthful eating and physical activity skills coaching intervention is more~          efficacious, relative to the general health education coaching group, in preventing~          increases in body fat percentage, body mass index percentile, waist circumference,~          systolic and diastolic blood pressure, and sedentary behavior~        -  whether the healthful eating and physical activity skills coaching intervention is more~          efficacious, relative to the general health education coaching group, in facilitating~          increases in quality of life, moderate-to-vigorous physical activity, enjoyment of~          physical activity and fruit and vegetable consumption, and self-efficacy for physical~          activity and fruit and vegetable consumption.~      We hypothesize that the research project will be successful in recruiting and retaining~     participating families, training research assistants to deliver the intervention components,~     and that both of the coaching conditions will be well received and appreciated by~     participating families. We hypothesize that the healthful eating and physical activity skills~     coaching intervention will be more effective than the support coaching condition in~     preventing increases in blood pressure, airway dysfunction and adiposity. We expect that both~     intervention conditions will show improvements to pediatric quality of life measures, but~     that the healthful eating and physical activity skills coaching intervention will be more~     effective than general health education coaching condition in increasing physical activity,~     physical activity enjoyment and self efficacy, fruit and vegetable consumption, and fruit and~     vegetable enjoyment and self-efficacy.~   "
131548|NCT01845467|"~     BACKGROUND:~      Auto immune pancreatitis (AIP), a benign pancreatic disease has certain morphological forms~     which mimics pancreatic malignancy in radiological appearance. There is no singe diagnostic~     test which can accurately differentiate these two conditions. In the past, AIP accounted for~     up to 27% of Whipple resections performed for suspected adenocarcinoma.~      AIMS:~      To evaluate the efficacy of Secretin assisted Magnetic resonance cholangio pancreatography~     (MRCP) in differentiating AIP and pancreatic malignancy.~      METHODS:~      100 patients suspected with AIP will be consented to participate in the study to undergo~     secretin MRCP in addition to their other standard investigations. Patients will be~     categorized as those with AIP and with pancreatic malignancy based on these results and will~     be followed. Follow up will eventually give the true diagnosis when patients with pancreatic~     malignancy undergo pancreatic surgery and their pancreatic tissue is examined by~     histopathologist. AIP patients will undergo steroid trial which will give the true diagnosis.~     The preliminary diagnosis results based on standard investigations with and without inclusion~     of secretin MRCP will be compared to the true diagnosis.~   "
131549|NCT01845454|"~     The primary objective of this study is to determine the percentage segment regression after~     spray cryotherapy in a dose-escalation study performed in patients with dysplastic Barrett's~     Esophagus (BE) using trūFreeze™ spray cryotherapy within the currently recommended~     therapeutic range.~      Secondary objectives are the determination of safety related outcomes such as esophageal~     stricture.~   "
131550|NCT01845441|"~     Dexmedetomidine is a unique sedative medication able to provide sedation without causing~     respiratory depression and maintaining neurological functions. Patients having an acute~     ischemic stroke and need to undergo endovascular therapy require constant assessment of their~     neurological status prior, during and after the interventional procedure. In this study the~     investigators will compare the efficacy of Dexmedetomidine to other standard sedative~     medications in providing optimal sedative effect while maintaining neurological function.~   "
131551|NCT01845428|"~     The purpose of this research study is to learn if using statin in patients with nephrotic~     syndrome could lower the risk of blood clots. Nephrotic syndrome is a collection of signs and~     symptoms that occur when the glomeruli -the tiny filters that work in the kidney- leak~     protein in the urine.~      One of the symptoms associated with nephrotic syndrome is hyperlipidemia: too much bad~     cholesterol (LDL). This bad cholesterol could be linked to the increased risk of blood clots~     in patients with nephrotic syndrome. The study doctors would like to see if taking a statin~     drug to reduce the amount of bad cholesterol could reduce the risk of blood clots.~   "
131552|NCT01845415|"~     Currently, six Public Health Units (PHUs) in Southwestern Ontario are taking part in the~     developed and implementation of a social marketing intervention campaign aimed at lowering~     the incidence of falls to children in the home; City of Hamilton - Public Health Services~     (Control), Durham Public Health, Haldimand-Norfolk Health Unit, Niagara Region Public Health,~     Wellington-Dufferin-Guelph Public Health and Windsor Public Health (Control). This campaign~     is based on community-based intervention research and 'best practices' for improving parent~     attitudes and behaviours toward child safety. The campaign will focus on increasing parents'~     awareness and knowledge of fall injuries, positively impact parental attitudes to motivate~     them to want to implement strategies to reduce fall risks, and increase parental safety~     practices that would counteract the most common mechanisms that contribute to home falls for~     children at these young ages. The campaign will run from September 2013 through August 2014.~     The PHUs' social marketing campaign will strategically disseminate different materials to~     their respective communities: printed materials (posters, pamphlets), video modules about~     parenting safety, safety information through an e-Health website, and direction communication~     with parents through Family Health Team practitioners.~      The proposed research project will request archival data from Canadian Institute of Health~     Information (CIHI), specifically from their National Ambulatory Care Reporting System~     (NACRS), on frequency of falls in the home to determine the extent to which the social~     marketing campaign is effective. Comparing pre-, during and post-intervention levels in the~     PHU communities will determine if and which social marketing strategies were effective.~     Additionally, random digit dialing will be used to assess pre vs post parental fall related~     attitudes, behaviors and intervention exposure. This evaluation will provide the first ever~     test of a community level intervention to reduce childhood falls in the home in Canada and~     will provide valuable information about what constitutes 'best practices' for preventing~     falls in the home among children 1 through 4 years of age.~   "
131553|NCT01845402|"~     The prevalence of chronic kidney injury (CKD) following cardiac surgery during childhood is~     not known, but there is evidence of CKD in young adults. In the present study assumption is~     made that CKD can already by diagnosed in patients at or just before adolescence, and the aim~     is calculate its prevalence according to the KDIGO criteria by a cross-sectional study, which~     will enroll patients aged 10 to 15 years. The second hypothesis is that events occurring~     peri-operatively during initial surgery or during follow-up could by chart review and~     regression analysis.~   "
131554|NCT01845389|"~     Geriatric patients have a significantly higher incidence of morbidity and morality during~     surgery compared with younger age group. Transurethral resection of the prostate (TURP) is~     the gold standard treatment for elderly patients with bladder outlet obstruction. Thus~     Regional techniques may be better tolerated in the elderly patients undergoing TURP having~     the advantages of minimizing blood loss and thromboembolic events. The Wiley Spinal™ (Epimed;~     Johnstown, NY) catheter is an innovative flexible cannula over needle designed for convenient~     intrathecal access that reduces PDPH. We hypothesized that using less anesthetics during~     continuous spinal anesthesia with the Wiley spinal catheter would offer more hemodynamic~     stability with less side effects when compared with continuous epidural anesthesia in~     patients undergoing TURP~   "
131555|NCT01845376|"~     This present randomized trial is designed to evaluate the postoperative pain,inflammatory~     marker, postoperative analgesic medication, length of hospital stay and the modifications of~     inflammatory mediators in patients undergoing inguinal hernia repair using local, spinal or~     general anesthesia.~   "
131556|NCT01845363|"~     Eighteen patients were given a dose of 2g Cefazolin in anesthetic induction, supplemented~     with 1g delivered through continuous infusion during surgery. Adipose samples, obtained at~     the beginning and end of surgery, were analyzed using high performance liquid chromatography.~      Some published studies suggest that the dose of 2g does not supply the minimum inhibitory~     concentration for principal causal agents of surgical site infection.~      To determine the concentration of Cefazolin in adipose tissue of patients undergoing~     bariatric surgery and to evaluate the relationship between concentrations obtained and body~     mass index (BMI).~   "
131557|NCT01845350|"~     The purpose of this study is to determine whether M2 macrophages are safe and feasible in the~     treatment of non-acute stroke patients~   "
131895|NCT01840943|"~     The purpose of this study is to compare the effectiveness between CAELYX and topotecan~     hydrochloride (HCl) in Chinese participants with recurrent epithelial ovarian carcinoma~     following failure of first-line, platinum-based chemotherapy, who have received no more than~     one prior platinum-based regimen therapy.~   "
131561|NCT01845298|"~     The investigators' objective is to describe the variability of rifampicin absorption, markers~     of inflammation and gut damage, intestinal absorptive capacity, and intestinal permeability~     among HIV-infected volunteers. Rifampicin is the least well absorbed of the first-line~     anti-tuberculosis drugs. Rifampicin malabsorption is frequently observed in HIV-infected~     patients with active tuberculosis, but cannot be predicted by patient factors such as CD4+ T~     cell count, viral load, or the presence of diarrhea. The mechanisms for rifampicin~     malabsorption in HIV-infected patients are unknown. An understanding of mechanisms for~     rifampicin malabsorption could eventually lead to new therapeutic targets, with the ultimate~     goal of improving HIV/tuberculosis treatment outcomes.~   "
131562|NCT01845285|"~     The purpose of this postmarket Registry is to assess the standard of care and clinical~     outcomes of the Direct Flow Medical Transcatheter Aortic Valve System used in clinical~     routine according to the approved commercial indications. Procedures and assessments required~     by this registry are generally considered standard of care for Transcatheter Aortic Valve~     Replacement patients.~      Evaluation criteria will be the incidence of mortality/morbidity and adverse events clinical~     performance, and hemodynamic performance of the DEVICE via ultrasound (echo) and angiographic~     imaging.~   "
131563|NCT01845272|"~     This study is designated to evaluate the pharmacokinetic interactions of candesartan~     cilexetil and amlodipine besylate in healthy male volunteers.~   "
131564|NCT01845259|"~     Metabolic disturbances, obesity and life-shortening cardiovascular morbidity are major~     clinical problems among antipsychotic-treated patients. Especially two of the most~     efficacious antipsychotics, clozapine and olanzapine, cause weight gain and metabolic~     disturbances and can rarely be replaced by other drugs due to the effectiveness of the~     compounds. Glucagon-like peptide 1 (GLP-1) has improved glycemic control among patients with~     type 2 diabetes. The study will investigate whether the beneficial effects of GLP-1 analogues~     on glycemic control in type 2 diabetic patients, can be extended to a population of~     non-diabetic, dysglycemic psychiatric patients, receiving antipsychotic medical treatment.~   "
131565|NCT01845246|"~     Objectives: Main objective: to assess the impact of an intervention for optimizing the dosing~     of colistin based on its plasma levels in patients with infections due to multi-drug~     resistant gram negative bacilli. The impact will be evaluated in terms of clinical and~     microbiological outcome, and toxicity.~      Secondary objectives:~        1. To determine the percentage of patients reaching plasma levels considered adequate (Cmax~          / MIC 8-10) for the treatment of infections due to gram-negative bacilli susceptible to~          colistin, in the cohort of patients treated with standard doses of this drug without~          adjusting the dose.~        2. To analyze the possible emergence of bacterial resistance to this drug and its~          relationship to the calculated colistin pharmacokinetic and pharmacodynamic indexes.~      Methods:~      Design: open controlled trial, blinded for the analyst, to be performed at thre tertiary care~     Hospitals in Barcelona.~      Subjects: Patients attended consecutively between 2012 and 2013 infected with multi-drug~     resistant gram negative bacilli and treated with colistin.~      Sample size: 142 cases. Intervention: Once detected the infection requiring treatment with~     colistin, patients will be randomized to receive the intervention or not, with a 1:1 ratio.~     The intervention will be performed by an Infectious Diseases physician and will consist in a~     recommendation on the dose of colistin based on its plasma levels 48 hours after treatment~     onset.~      Variables: peak and through colistin levels 48 hours after treatment onset, clinical,~     analytical and microbiological data at baseline and during follow-up of the patients.~      Outcome measures: clinical, microbiological and toxicity data. Analysis: Comparison of~     patient characteristics and outcome variables between patients who had received the~     intervention and those who had not. The analysis will be done by intention to treat, by~     biological effectiveness and by compliance with the protocol.~   "
131566|NCT01845233|"~     The purpose of this study is to determine whether clinical examination, report from~     ventilator software, nocturnal Sp02 and daytime arterial blood gas are sufficient as~     screening tools to reveal clinical relevant problems with patients receiving long term~     treatment with non invasive ventilation.~   "
131567|NCT01845220|"~     This study is designed to determine whether Asians who are especially sensitive to alcohol~     exposure can be protected by boosting their activities of an alcohol disposing enzyme. This~     will be accomplished by administering broccoli sprouts that are rich in an agent that~     increases protective enzyme activity. The test system involves applying alcohol patches to~     the skin and measuring skin redness.~   "
131568|NCT01845207|"~     Frailty is a state of decreased physiologic reserves and vulnerability to stressors. Several~     tools exist to measure frailty, some based on physical tests and others on questionnaires,~     yet there is no agreement on which tool to recommend. This multi-center prospective cohort~     study is aimed at comparing various frailty assessment tools to determine which best predicts~     death or major complications after cardiac surgery or transcatheter intervention. The~     population of interest is elderly patients with severe aortic stenosis undergoing surgical or~     transcatheter aortic valve replacement. The frailty assessment tools under investigation~     include composite frailty scales, physical performance tests, muscle mass, and biomarker~     expression. The overall objective is to improve our ability to predict risk by measuring~     frailty using the optimal tool in elderly cardiovascular patients.~   "
131569|NCT01845194|"~     This human pharmacokinetic study investigates, whether processes of drug metabolism and~     transport are determined by genetic or hereditary factors. Therefore, approved drugs are~     applied to twins and metabolism and transport processes are investigated.~   "
131570|NCT01845181|"~     This is a phase I, single-center, randomized, double-blind, dose escalation study without~     therapeutic benefit, in which PBF-680 will be administered as single oral ascending dose to~     young male healthy volunteers. Up to four different rising doses will be tested in groups of~     8 participants. Thus, four groups will participate but each one participating only once. For~     each dose level / group the participants will be randomized to active or placebo with 2~     participants being randomly assigned to placebo and 6 to the active drug. First, one~     volunteer will receive active drug (subgroup 1); after 48h of safety and tolerability~     assessment a second subgroup of 3 volunteers will receive 2 active drug and 1 placebo; after~     48h of safety and tolerability parameters assessment a third subgroup of 4 volunteers will~     receive 3 active drug and 1 placebo. After evaluation of safety parameters of dose level the~     process will replicate one week afterwards in the following dosages.~      The aims of this study are:~      Primary:~      - To assess the safety and tolerability of single escalating oral doses of PBF-680 in young~     male healthy subjects leading to the determination of the maximum tolerated dose (MTD).~      Secondary:~        -  To assess the pharmacokinetics of PBF-680 after single rising oral doses in healthy~          young male subjects.~        -  To asses the preliminary pharmacodynamic effects.~        -  To evaluate the adenosine A1 receptor antagonism in blood samples of healthy volunteer~          caused by the PBF-680 administration~   "
131938|NCT01840384|"~     This study is initiated to investigate the effect of multi micronutrient supplementation for~     12 months on serum haemoglobin level in Indonesian young children.~   "
131571|NCT01845168|"~     The purpose of this study is to investigate if a computerised decision-support tool used in~     general practice, can reduce the frequency of peptic ulcer bleeding related to the use of~     NSAIDs (Non-Steroidal-antiinflammatory-drug) and ASA( Acetylsalicylic acid) .~      On the basis of The Danish general medical database it is possible to develope a~     computerised decision-support tool, which enables the general practitioner (GP) in a pop-up~     window to get information on each patients risk-factors, when prescribing NSAID and aspirin~     to a patient at risk. This will give the general practitioner the oppurtunity to choose a~     different type of preparation or prescribe ulcer-preventive medicine at the same time.~      The decision-support tool will be tested in a randomized trial among general practitioners.~     The aim is to reduce the occurence of peptic ulcer bleeding. The expected outcome is a~     reduction in half of the total numbers of peptic ulcers.~   "
131572|NCT01845155|"~     BACKGROUND: Tinnitus is a nonspecific symptom of hearing disorder characterized by the~     sensation of buzzing, ringing, clicking, pulsations, and other noises in the ear. Despite a~     variety of treatments, many patients with chronic tinnitus ask for more active ways in coping~     with their tinnitus. Gold standard treatment in chronic tinnitus is a comprehensive directive~     counseling explaining the underlying mechanisms leading to the tinnitus percept. Therefore a~     neuro-music therapeutic treatment based on a bio-psycho-social framework was developed and~     compared to a counselling-only control group.~      INTERVENTION: two standardized protocols for tinnitus therapy were defined (neuro-music~     therapy vs. counselling)~   "
131573|NCT01845142|"~     Vitamin D receptors are expressed in activated different immune cells. It is not known, which~     immune cell type is targeted by exogenous vitamin D. Here, vitamin D-deficient individuals~     will receive once 100.000 I.U. vitamin D3 either intramuscular or subcutaneous in a~     double-blind placebo controlled setting. Immune cells will be monitored from the blood over~     time.~   "
131574|NCT01845129|"~     The present study assesses whether language functions in patients with residual post-stroke~     aphasia can be improved by transcranial direct current stimulation administered to the~     primary motor cortex in the language dominant (left) hemisphere.~   "
131575|NCT01845116|"~     The purpose of this study is to determine whether the omega-3 fatty acid emulsion~     (Omegaven®), when used in place of the conventional soy-based fat emulsion (Intralipid), is~     effective in treating parenteral nutrition associated liver disease (PNALD) in children.~      The study hypothesis is that Omegaven® can be safely provided to children who are dependent~     on parenteral nutrition and have PNALD, and can reverse or prevent progression of PNALD until~     the child can take adequate nutrition by mouth.~   "
131576|NCT01845103|"~     This is a prospective single arm study of the Cardiogenesis PEARL 8.0 Handpiece Delivery~     System. The purpose of this study is to demonstrate that the 30 day mortality rate among~     patients who are treated with this device is less than the historical rate plus a~     non-inferiority margin.~   "
131577|NCT01845090|"~     To compare the effect of lanthanum carbonate with calcium carbonate on serum FGF23 levels in~     hemodialysis patients.~   "
131578|NCT01845077|"~     The purpose of the trial is to demonstrate the relative bioavailability of 2 newly developed~     fixed dose combination (FDC) tablets containing linagliptin & metformin and the single~     tablets of linagliptin and metformin when administered singularly.~   "
131579|NCT01845064|"~     DM199 (recombinant human tissue kallikrein-1) is a new investigational compound that may~     eventually be used for the treatment of Diabetes Mellitus Type 2. This is the first time that~     this compound is being given to humans.~      The purpose of the study is to investigate to what extent DM199 is safe and tolerated.~     Further, it will be investigated how quickly and to what extent DM99 is absorbed and~     eliminated from the body (this is called pharmacokinetics). In addition, the effect of the~     compound on the body will be investigated (this is called pharmacodynamics).~      This study is not intended to improve anyone's health, but is necessary for the further~     development of DM199.~      The study consists of 4 parts. Each part (A, B, C and D) will consist of one or several~     periods. The research will be conducted in healthy male and female volunteers (Part A and C)~     and in male and female type 2 diabetes mellitus patients (Part B and D).~   "
131580|NCT01845051|"~     The researchers investigated the relationship between migraine and allergy. For this purpose,~     the researchers designed a controlled study to evaluate nasal symptoms and signs; and to~     perform Specific Immunoglobulin E (IgE) measurements in migraine patients and healthy~     subjects. According to these results the prevalence of allergic rhinitis in migraine group~     was planned to be compared to that of the healthy controls, statistically.~   "
131581|NCT01845038|"~     The purpose of this study is to evaluate how OTX-TP, a sustained release travoprost drug~     product, when placed in the canaliculus of the eyelid compares to timolol drops for the~     lowering of intraocular pressure (IOP) in patients with open angle glaucoma or ocular~     hypertension.~   "
131582|NCT01845025|"~     The purpose of this study was to assess whether the risk of serious asthma-related events~     (asthma-related hospitalizations, asthma related intubations, and asthma related deaths) in~     adolescents and adults (12 years of age and older) taking inhaled formoterol~     fumarate/fluticasone propionate combination was the same as those taking inhaled fluticasone~     propionate alone.~   "
131583|NCT01845012|"~     HDQ 200 is an interventional multicenter study. This is a before-and-after design in which~     the patient is his own control. The main objective of the study is to determine the~     percentage of success of a procedure of daily hemodialysis at low dialysate flow. All~     patients treated with conventional hemodialysis, for at least 3 months and clinically stable,~     can be included in the study. Their 3 months data prior to inclusion is collected~     retrospectively. These 3 months of conventional hemodialysis are the reference period.~     Patients are then treated with daily hemodialysis at low dialysate flow for 3 months. During~     this 3 months period, the same data as during the period of conventional hemodialysis are~     collected prospectively.~   "
131584|NCT01844999|"~     The purpose of this study is to determine whether using the P3P website can increase~     decisional preparation and satisfaction, and decrease decisional conflict, in men deciding~     how to manage early stage prostate cancer.~   "
131585|NCT01844986|"~     Olaparib Monotherapy in Patients with BRCA Mutated Ovarian Cancer following First Line~     Platinum Based Chemotherapy.~   "
131586|NCT01844973|"~     This study is to evaluate the pharmacokinetics and safety of M518101 in male and female~     plaque psoriasis patients.~   "
131587|NCT01844960|"~     A double blinded randomised control trial comparing the differences between laparoscopic~     single incision versus multiple port bariatric surgery in morbidly obese patients (BMI>35).~     Single incision surgery is a new minimally invasive surgical technique requiring the surgeon~     to operate through one small single incision and is virtually scarless. The traditional~     laparoscopic approach to abdominal surgery is through multiple small incisions (4-7 ports)~     across the whole abdomen. This study seeks to identify the risks, benefits and costs of the~     adjustable gastric band insertion via single incision and multiple incision within the~     morbidly obese patient group.~   "
131588|NCT01844947|"~     This study aims to analyse the tolerability (side effects and safety) with standard treatment~     (Javlor®) with the addition of a second anti-tumour drug: sorafenib (Nexavar®). This is the~     first time this treatment combination is studied in humans. Samples of blood, urine and~     tumour tissues will be analysed for molecular biomarkers. These biomarkers may potentially~     help us in the future in predicting whether a patient will benefit or not from the cancer~     treatment. The study also aims to investigate if a newer imaging method, called PET-CT~     (positron emission tomography-computed tomography), at an earlier stage (than a normal CT~     scan) can identify patients who will benefit from the given treatment.~   "
131589|NCT01844934|"~     A study comparing the benefits of pre-habilitation exercise to standard care prior to total~     knee arthroplasy~   "
131590|NCT01844921|"~     This is a single center, single arm, open label observational trial of patients undergoing~     EGD. The primary objective of this clinical trial is to evaluate the ability of physicians to~     position the NvisionVLE catheter to acquire an image of an area of the esophagus to identify~     and discriminate abnormal areas of tissue from normal.~   "
131591|NCT01844908|"~     Postoperative ileus remains a significant medical problem after colorectal surgery that~     adversely influences patients' recovery. The investigators previous study demonstrated that~     electroacupuncture (EA) at Zusanli, Sanyinjiao, Hegu, and Zhigou reduces the duration of~     postoperative ileus and hospital stay after laparoscopic resection of colonic and upper~     rectal cancer. Patients with mid/low rectal cancer undergoing laparoscopic total mesorectal~     excision (TME) or abdominoperineal resection (APR) were excluded. However, these complex~     cases are more likely to develop prolonged ileus and morbidity after surgery, and it is~     uncertain whether EA will be beneficial to them. The investigators therefore propose to~     conduct a prospective cohort study to evaluate the efficacy of EA in preventing prolonged~     ileus after laparoscopic surgery for mid/low rectal cancer. Fifty consecutive patients with~     mid/low rectal cancer undergoing laparoscopic TME or APR without the need of conversion will~     be recruited. All patients will undergo 1 session (20 minutes) of EA daily from postoperative~     day 1 till day 4. These patients will be compared with a matched historical control group~     (1:2) who underwent laparoscopic TME or APR without EA. The primary outcome is the incidence~     of prolonged ileus, which is defined as the inability to tolerate fluid diet by 4 days after~     surgery, associated with the need for nasogastric decompression and/or parenteral nutrition~     support. Secondary outcomes include time to defecation and duration of hospital stay. Results~     of this study will help clarify the efficacy of EA in preventing prolonged ileus after~     laparoscopic rectal surgery, and may provide the basis for planning a larger randomized~     controlled trial.~   "
131592|NCT01844895|"~     The purpose of this study is to implement a substudy in approximately 120 rheumatoid~     arthritis (RA) subjects to compare the steady-state serum trough concentration (Cminss), Cmax~     and area under the curve (AUC) during the dosing interval (TAU) of subcutaneous (SC)~     Abatacept injection of 125 mg via the autoinjector and via the BD Hypak™ Physiolis prefilled~     syringe.~   "
131593|NCT01844882|"~     Chronic kidney disease (CKD) is a debilitating condition in which there is a gradual decline~     of renal function associated with increased overall mortality. Most dietary guidelines for~     CKD focus on limiting protein intake (nitrogen) and high phosphorus-containing foods.~     However, increasing dietary fiber has been proposed to increase fecal nitrogen excretion~     which may ameliorate the progress of CKD. We therefore plan to conduct a systematic review~     and meta-analysis on clinical trials to assess the effect of fiber on urea and creatinine as~     classical markers of a state of uremia in individuals with CKD. We hypothesize that~     increasing fiber intakes will improve urea and creatinine levels in individuals with CKD.~   "
131594|NCT01844869|"~     The purpose of this study is to determine the pharmacokinetic and safety profiles of~     omacetaxine and its metabolites in patients with relapsed and/or refractory hematologic~     malignancies or advanced solid tumors following subcutaneous (sc) administration.~   "
131595|NCT01844856|"~     This is a Phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to~     assess the efficacy, safety, and pharmacokinetics of eravacycline compared with ertapenem in~     the treatment of adult complicated intra-abdominal infections (cIAI).~   "
131596|NCT01844843|"~     Purpose of this study is to evaluate, after implantation of a drug eluting stent (DES),~     coverage of the stent struts by new tissue. The evaluation will be performed by means of~     intravascular imaging technology (optical frequency domain imaging, OFDI). Renewed tissue~     coverage over the implanted stent struts prevents direct contact between blood and~     metal/polymer, which could lead to adverse events: patients need to take blood-thinning drugs~     to prevent these events. Ous new stent has drug and polymer only on the outside of the stent,~     and the polymer is degraded by the body leaving a bare metal stent after 3-4 months. This~     should allow fast coverage of the struts, and might allow to reduce duration of the~     supportive medical treatment. Our hypothesis is that <20% of the struts remain uncovered at 3~     months after implantation, as assessed by OFDI.~   "
131597|NCT01844830|"~     The purpose of this study is to compare the efficacy of Kovacaine Mist, and Placebo for~     inducing pulpal anesthesia of the maxillary teeth in pediatric patients.~   "
131598|NCT01844817|"~     The purpose of this study is to compare the overall survival in patients with previously~     untreated metastatic pancreatic cancer receiving gemcitabine/nab-paclitaxel plus OGX-427 or~     gemcitabine/nab-paclitaxel plus placebo.~   "
131599|NCT01844804|"~     In this study, healthy volunteers will receive a single intravenous dose of either~     PF-06438179 or infliximab (United States) or infliximab (European Union). During the course~     of the study, the pharmacokinetics will be assessed by sampling the levels of drug in the~     blood, and by comparing these levels among the different administration arms of PF-06438179~     and the licensed infliximab products. Safety, tolerability, and immunologic response will~     also be evaluated throughout.~   "
131601|NCT01844778|"~     The purpose of this interventional Phase IV study was to explore the ease of use of TIP and~     prevalence of microbial contamination of the T-326 Inhaler compared with TIS and~     colistimethate administered via nebuliser for the treatment of Cystic Fibrosis (CF) patients~     chronically infected with P. aeruginosa.~      It was anticipated that the data from this study would provide clinicians with further~     guidance on the relative differences between the speed and ease of use of these treatments as~     well as useful information on the prevalence of microbial contamination of the inhalation~     devices in real world use.~   "
131602|NCT01844765|"~     To evaluate the safety, efficacy and concentration of nilotinib over time in the Ph+ chronic~     myelogenous leukemia (CML) in pediatric patients (from 1 to <18 years).~   "
131603|NCT01844752|"~     This is a 12 week clinical trial in subjects with acne vulgaris. Subjects will be randomized~     to NVN1000 1% Gel, NVN1000 4% Gel or Vehicle Gel twice daily. Safety, tolerability and~     efficacy will be assessed over the course of the study.~   "
131604|NCT01844739|"~     This is a 2 week Phase 1 study of SB204 (NVN1000 Gel) in healthy adult volunteers with~     elevated Propionibacterium acnes (P. acnes) counts. Subjects will apply NVN1000 4% Gel or~     Vehicle Gel twice daily to their face. Assessments will include cutaneous tolerability,~     safety, and P. acnes counts.~   "
131605|NCT01844726|"~     The present study proposes to evaluate the potential cognitive enhancing effects of GLYX-13,~     an NMDAR partial agonist, among a group of healthy adults and those with psychiatric illness~     on a series of functional magnetic resonance imaging (fMRI) learning and memory tasks.~   "
131606|NCT01844713|"~     This study is being done to evaluate the effectiveness of a Sun Protection Strategies~     workbook for kidney transplant recipients. Since the medication taken to preserve the kidney~     transplant puts kidney transplant recipients at an increased risk of developing skin cancer.~     The program will help people learn about how to practice effective sun protection after the~     transplant.~   "
131607|NCT01844700|"~     We will conduct a 12-week, randomized open label study, comparing usual care (UC)~     antipsychotic treatment (aripiprazole, quetiapine, risperidone) with ziprasidone (ZIP) in~     children and adolescents aged 13-18 years old. Patients will have 10 days or less lifetime~     antipsychotic exposure and be in clinical need for antipsychotic treatment for a pediatric~     psychiatric disorder with FDA indication for antipsychotic use, i.e., bipolar mania,~     schizophrenia-spectrum disorders, and irritability associated with autistic disorder. In~     addition, we will also include youth fulfilling research diagnostic criteria for severe mood~     dysregulation (SMD). Randomization will be stratified by high vs. low genetic risk for~     antipsychotic-induced weight gain based on MC4R genotype and the primary outcome will be~     weight change from baseline to endpoint between ZIP and UC antipsychotic treatment in each of~     the two genotype groups. As detailed below, other metabolic and cardiac safety parameters~     will also be measured and compared across treatments in each of the genotype groups.~   "
131608|NCT01844687|"~     The objective of this study is to assess the effects of oral cannabidiol (CBD; 0, 200, 400,~     800 mg) on smoked marijuana's (0, 5.6% THC) subjective, reinforcing, cognitive, and~     cardiovascular effects. This experiment is expected to reveal CBD's intrinsic effects when~     combined with placebo marijuana, as well as its ability to modulate the behavioral effects of~     active marijuana.~   "
131609|NCT01844674|"~     This open-label, multicenter, 3-period, fixed-sequence study will evaluate the effect of~     multiple oral doses of vemurafenib on the pharmacokinetics of a single oral dose of~     tizanidine in participants with BRAFV600 mutation-positive metastatic malignancies.~     Participants will receive a single oral dose of tizanidine on Day 1, vemurafenib orally twice~     daily on Days 2 to 21, and tizanidine and vemurafenib on Day 22. Eligible participants will~     have the option to continue treatment with vemurafenib as part of an extension study~     (NCT01739764).~   "
131610|NCT01844661|"~     The investigators will evaluate the safety of weekly infusions (n=6) of CELYVIR in children~     and adults with metastatic and refractory solid tumors. CELYVIR consists in bone~     marrow-derived autologous mesenchymal stem cells (MSCs) infected with ICOVIR5, an oncolytic~     adenovirus. In addition to data on toxicities the investigators will evaluate clinical~     response.~   "
131611|NCT01844648|"~     To study the safety and efficacy of tropicamide 1 mg intra-oral slow dissolving muco-adhesive~     thin films compared to placebo to reduce hypersalivation in PD patients manifesting~     sialorrhea complaints.~   "
131612|NCT01844635|"~     The objective of this study is to evaluate the feasibility and effectiveness of~     immunosuppressive therapy (IST) using rabbit anti-thymocyte globulin (ATG) (Thymoglobuline,~     Genzyme) for patients with very severe aplastic anemia (VSAA) and severe aplastic anemia~     (SAA) as a primary therapy. The primary endpoint is the response rate (complete response (CR)~     + partial response (PR)) at day 180 after the start of IST. Secondary endpoints include~     evaluation of the presence and frequency of Epstein-Barr virus (EBV)-reactivation and~     EBV-associated lymphoproliferative disorder (EBV-LPD), Cytomegalovirus(CMV)-reactivation and~     CMV associated diseases, the response rate (CR+PR) on Day 360 after the start of IST, relapse~     rate and overall survival.~   "
131613|NCT01844622|"~     The purpose of the study is to treat patients with on-going slow stomach~     emptying(gastroesophageal reflux disease), who have failed to respond to standard therapy~   "
131614|NCT01844609|"~     The purpose of this study is to determine if an intensive journal club based on articles and~     materials provided on the journal Obstetrics and Gynecology Website improves written and~     spoken comprehension of medical English in a population of Chinese medical professionals.~   "
131636|NCT01844323|"~     The particle size of the active ingredient may impact dissolution rate in the gastro~     intestinal tract and hence the amount of drug available for absorption. Similarly,~     differences in the percentage of the excipients used in the formulated capsules may affect~     dissolution rate. The purpose of this study is to estimate the effect that particle size and~     percentage of excipients could have in drug absorption, which will improve the manufacturing~     process of the formulated capsules.~   "
131637|NCT01844310|"~     This study is to evaluate the safety and efficacy of RAL-based regimen in~     treatment-experienced patients with resistant HIV infection~   "
131638|NCT01844297|"~     This study aims to evaluate the safety and effectiveness of the tenofovir disoproxil fumarate~     (TDF) + lamivudine (3TC) + efavirenz (EFV) regimen in antiretroviral therapy (ART)-naive~     Chinese HIV/AIDS patients.~   "
131615|NCT01844596|"~     Cardiovascular disease (CVD) is the leading cause of death in sub-Saharan Africa among adults~     above age 30. The prevalence of hypertension, a major risk factor for CVD, is increasing over~     time in sub-Saharan Africa, exerting a significant epidemiologic and economic burden on the~     region. Without adequate control of hypertension, its health and economic burden will~     increase drastically in the decades ahead. Well established and evidence-based interventions~     to manage hypertension exist; however, treatment and control rates are low.~      A critical component of hypertension management is to facilitate sustained access of affected~     individuals to effective clinical services. In partnership with the Government of Kenya, the~     United States Agency for International Development-Academic Model Providing Access to~     Healthcare Partnership (AMPATH) is expanding its clinical scope of work in rural western~     Kenya to include hypertension and other chronic diseases.~      However, linking and retaining individuals with elevated blood pressure to the clinical care~     program has been difficult. Thus, the overall objective of this application is to utilize a~     multi-disciplinary implementation research approach to address the challenge of linking and~     retaining hypertensive individuals to a hypertension management program. We aim to add to~     existing knowledge on scalable and sustainable strategies for optimizing control of~     hypertension and other chronic diseases in low- and middle-income countries.~   "
131616|NCT01844583|"~     Safety, tolerability and PK of concomitant esomeprazole and rifampin, and QT study on single~     and multiple-doses of alisertib~   "
131617|NCT01844570|"~     The purpose of this study is to determine whether the effectiveness of levamlodipine maleate~     (xuanning) is noninferior to amlodipine besylate (Norvasc) in treatment of hypertension in a~     Chinese primary hypertension population.~   "
131618|NCT01844557|"~     The goal of this research study is to look for factors that influence whether or not head and~     neck cancer patients follow the swallowing exercises that they are asked to perform while~     receiving radiation treatment.~   "
131619|NCT01844544|"~     the purpose of the study is to:~        1. Identify and characterize drug related problems in patients after a femur neck fracture~          that are hospitalized in the orthopedic department at Meir medical center.~        2. Evaluate the contribution of a clinical pharmacist in identifying,characterizing and~          preventing drug related problems in patients after a femur neck fracture that are~          hospitalized in the orthopedic department at Meir medical center.~   "
131620|NCT01844531|"~     The primary objective of this trial is to establish bioequivalence of two fixed dose~     combination (FDC) tablets (containing medium dose empagliflozin/500 mg metformin [Test 1] and~     low dose empagliflozin/500 mg metformin [Test 2]) and of the single tablets (medium dose~     empagliflozin tablets + Glucophage® 500 mg tablet [Reference 1] and low dose empagliflozin~     tablet + Glucophage® 500 mg tablet [Reference 2]) when administered together after a high~     fat, high caloric meal.~      The assessment of safety and tolerability will be an additional objective of this trial.~   "
131621|NCT01844518|"~     The purpose of this study is to estimate Abatacept steady-state trough concentration (Cmin)~     at Day 113 in children and adolescents with pJIA~   "
131622|NCT01844505|"~     The purpose of this study is to show that Nivolumab and/or Nivolumab in combination with~     Ipilimumab will extend progression free survival and overall survival compared to Ipilimumab~     alone.~   "
131623|NCT01844492|"~     One in five deaths in the U.S. occurs in or shortly after discharge from an intensive care~     unit (ICU), typically following decisions made by surrogate decision makers to forego life~     prolonging treatment. A large body of empirical research has identified deficiencies in care~     processes that contribute to three important problems: 1) family members often experience~     poor quality communication with ICU clinicians, leading to lasting psychological distress~     associated with the ICU experience; 2) patients near the end of life frequently receive~     invasive, expensive treatment that is inconsistent with their values and preferences, and 3)~     end-of-life care is a major contributor to health care costs.[8, 9] Although advance care~     planning can prevent some unwanted treatment, many patients wish for a trial of intensive~     treatment when the prognosis is uncertain, and therefore it seems likely that the need for~     interventions to improve in-the-moment decisions by surrogates will persist.[10, 11]~      In a pilot project, the investigators developed the PARTNER intervention (PAiring~     Re-engineered ICU Teams with Nurse-driven Emotional Support and Relationship-building), an~     interdisciplinary intervention that 1) gives new responsibilities and advanced communication~     skills training to existing ICU staff (local nurse leaders and social work members of the ICU~     team); 2) changes care defaults to ensure frequent clinician-family meetings; and 3) adds~     protocolized, nurse-administered coaching and emotional support of surrogates before and~     during clinician-family meetings. The objective of this proposal is to conduct a stepped~     wedge randomized controlled trial testing the PARTNER intervention in 5 ICUs among 1000~     patients with advanced critical illness and their surrogates.~   "
131624|NCT01844479|"~     In this pilot study, the first objective is to bench test a novel shear reducing insole and~     compare it to current standard insoles and shoes. The second objective is to study~     twenty-seven insensate diabetes patients with pre-ulcerative foot callus to examine for~     changes in spatial temporal gait including gait initiation, risk of falling, static and~     dynamic balance, and plantar temperature response to walking and consecutive plantar stress~     in both footwear conditions.~   "
131625|NCT01844466|"~     This is a prospective study of patients with stroke with accompanying motor and visual~     deficits. There will be patients' evaluations at 2 time points at the acute and subacute~     period after the stroke. Statistical correlation of the improvement of their deficits will be~     conducted~   "
131639|NCT01844284|"~     Prospective, Randomized (2:1), active control, single-blind, non-inferiority, multicenter,~     Japanese Clinical Trial to evaluate the safety and effectiveness of Absorb™ BVS (AVJ-301) in~     the treatment of subjects with ischemic heart disease caused by de novo native coronary~     artery lesions in Japanese population by comparing to approved metallic drug eluting stent.~   "
131653|NCT01844102|"~     The study will measure the incidence of moderate and severe adverse events (AEs) associated~     with PrePex procedures among 500 men, including both procedural and post-procedure events,~     and all device-related incidents such as dislodgment. To assure complete ascertainment of~     AEs, study-specific forms will be used to collect standardized data from the circumcision~     visit and all follow-up visits. Follow-up will be more intensive for the first 50 cases, and~     will transition to follow-up at two visits (7 and 42 days) for the remaining 450 cases.~   "
131626|NCT01844453|"~     The application of in-vitro fertilization (IVF) has provided remarkable opportunities for~     infertile couple to conceive in the last four decades. Historically IVF was performed for~     patients with bilateral tubal obstruction, but its use is presently widespread. Although the~     efficacy of assisted reproductive technology continues to improve, endometrial implantation~     remains the limiting step towards a successful pregnancy. Reduced endometrial receptivity and~     embryonic defects are the probable primary causes of implantation failure during IVF(1).~     Patients with repeated implantation failure despite transferring good-quality embryos~     continue to be a major dilemma for clinicians and are a topic of great research interest.~     Barash et al. unintentionally discovered and initially reported that an endometrial biopsy~     prior to IVF in women who have had one or more implantation failures was associated with an~     increased clinical pregnancy (66.7% vs 30.3%, p<0.01) and live birth rates 48.9% vs 22.5%,~     p=0.02) compared to a control group(2). The mechanism by which a local endometrial injury~     (LEI) may increase the pregnancy rate is still not fully clear. Possible etiologies include~     its role in promoting a beneficial local inflammatory response, inducing endometrial~     decidualization, or improving endometrial maturation synchrony (3-6).~      Following Barash et al's publication, several randomized controlled studies confirmed their~     findings (7-11). However, there has been extensive heterogeneity among studies, including the~     number of biopsies, how the biopsy is performed and the selected patient population. On the~     other hand all the studies have in common that the endometrial biopsy was performed prior to~     the start of the IVF cycle.~      The optimal timing of an endometrial biopsy with respect to an IVF cycle is unknown. There is~     reason to suspect that an endometrial biopsy during the follicular phase of an IVF~     stimulation cycle may improve pregnancy outcomes, although this has not been directly~     examined. We therefore propose a randomized controlled study to evaluate the impact of an~     endometrial biopsy on the implantation and pregnancy rate in both the luteal phase prior to~     the IVF cycle as well as the follicular phase of the concurrent IVF cycles.~   "
131627|NCT01844440|"~     The aim of this study is to establish and validate High resolution manometry (HRM) criteria~     for the definition of transient lower esophageal sphincter relaxations (tLESRs) in~     gastroesophageal reflux disease (GERD) patients.~   "
131628|NCT01844427|"~     This is a 12-week clinical trial evaluating the efficacy and safety of memantine~     hydrochloride (Memantine HC1, brand name Namenda) in the treatment of executive function~     deficits (EFDs) in adults with Attention Deficit Hyperactivity Disorder (ADHD). After~     screening procedures, memantine is prescribed in randomized, double-blind fashion (equal~     chance of medication or placebo) for 12 weeks.~      The investigators hypothesize that memantine hydrochloride will prove to be an effective,~     safe, and well-tolerated agent for the treatment of EFDs in individuals with ADHD interested~     in non-stimulant medications.~   "
131629|NCT01844414|"~     The purpose of this study is to conduct a prospective, three-group study that randomly~     assigns 700 parolees, in a community residential drug treatment program, to enter one of~     three groups: 1) a PCPC (Parolee Comprehensive Care + Phone Coaching Program), which includes~     nurse case management and specialized hepatitis education sessions and the hepatitis A/B~     (HAV/HBV) vaccination series (to all eligible) and coach-facilitated mentoring (mostly by~     cell-phone); 2) a Parolee Brief Hepatitis Education + HBV vaccination + Phone Coaching (PBCP)~     Program, which includes brief hepatitis/HIV education, HAV/HBV vaccination and~     coach-facilitated mentoring; or 3) a Usual Care (UC) control program, which includes brief~     general health information, one-on-one coaching and the HAV/HBV vaccine.~   "
131630|NCT01844401|"~     The primary objective of this study is to compare the pharmacokinetic (PK) profiles of~     Albuterol Spiromax® and ProAir HFA after administration of a single inhaled dose of 180 mcg~     albuterol base from each product.~   "
131631|NCT01844388|"~     This study will compare the safety and efficacy of a new carboxymethylcellulose based eye~     drop formula to Refresh Contacts® for lubricating and rewetting contact lenses.~   "
131632|NCT01844375|"~     This prospective randomized controlled study is designed to investigate whether preoperative~     oral carbohydrate loading improves postoperative walking performance, a surrogate indicator~     for overall functional recovery, in patients undergoing colorectal surgery as measured by~     2-minute and 6-minute walk test. The secondary outcomes are postoperative insulin resistance~     measured with plasma insulin and glucose concentrations. The tertiary outcomes are duration~     of hospital stay, patients satisfaction during staying in the hospital and morbidity measured~     as postoperative complications.~   "
131633|NCT01844362|"~     Uterus transplantation, as a possible future treatment for uterine factor infertility, has~     been developed in animal species during the last decade.~      The study protocol includes transplantation of the uterus from a live donor (mother,~     relative, friend) into women with absolute uterine factor infertility (lack of uterus from~     birth or due to life saving hysterectomy).The recipient will be treated by standard~     immunosuppression and transfer of embryos (acquired by IVF before surgery) will be attempted~     when at least 12 months have passed from transplantation. Approval for a case series~     including up to 10 patients has been acquired.~   "
131634|NCT01844349|"~     Problematic and state of the art Obesity and its associated non communicable diseases (NCDs)~     are rising rapidly in middle income countries, such as those in the Maghreb (North Africa).~     This progression is related to the context of a nutrition transition (changing food and~     physical activity environment) and profound changes in technological advances and in society.~     These societies and their health systems are insufficiently prepared for this evolution,~     which has enormous health and socioeconomic consequences. In the context of limited~     resources, the priority has been given on an international level to prevention. But several~     problems arise: - these countries are still confronted by undernutrition in terms of~     micronutrient deficiencies, which coexist with obesity and NCDs, including at a family level~     and also individual level. Known as the 'double burden', this coexistence is relatively new~     and has been rarely documented until recently. Educational measures could be ineffective in a~     society where cultural norms do not recognise obesity and where changes in lifestyle are~     possibly not seen as acceptable. As well as information about citizen's knowledge of risk~     factors, data on their perceptions and attitudes are indispensable. Policies that involve~     changing the 'obesogenic' environment that individuals occupy is a priority.~      Objectives of the project Overall aim: to contribute to the development of preventive~     strategies for obesity and chronic NCDs in the context of a nutrition transition.~      Specific objectives: characterise the nature and size of the double burden~     (obesity/undernutrition) in regions, families and individuals; estimate the prevalence of~     biological and behavioural risk factors; characterise the psycho-sociocultural determinants~     of behaviour.~   "
131635|NCT01844336|"~     The purpose of this study is to evaluate the performance of the PBASE system, in terms of the~     efficacy of treatment in patients with idiopathic rhinitis.~   "
131687|NCT01843660|"~     The purpose of this study is to evaluate the efficacy and safety of tramadol~     hydrochloride-paracetamol tablets in treatment of moderate (medium level of seriousness) to~     severe (very serious) acute neck, shoulder and low back pain in orthopedics (pertaining to~     the bones) outpatient or emergency setting.~   "
131640|NCT01844271|"~     Muscle fatigue and muscle recovery after exercise are recent areas of research involving Low~     Level Laser Therapy (LLLT) and many factors remain unknown, such as optimal doses, power and~     application parameters, mechanisms of action, effects on long-term exercise and the long-term~     effects on skeletal muscle recovery.~      The present research project aims to assess the effects of long-term recovery of LLLT in~     skeletal muscle after exercise and identify the optimal dose application of LLLT.~      After defining the best dose of application, we recruited two groups which will be irradiated~     with different power, 100mW and 400mW in order to seek the optimal parameter of low level~     laser therapy in performance.~      The investigators believed that the Low Level Laser Therapy can delay the physiological~     process of muscle fatigue, reduce injury or skeletal muscle microdamage arising from physical~     effort and accelerate muscle recovery after exercise.~   "
131641|NCT01844258|"~     Pediatric cataract is totally different from adult cataract. There is traditionally no~     difference in technique between pediatric and adult cataract surgery. Opacification of the~     visual axis was the most frequent complication after pediatric surgery. In this clinical~     study, the investigators aimed to evaluate the safety and postoperative recovery of a~     modified technique for pediatric cataract surgery.~   "
131642|NCT01844245|"~     Only a small proportion of patients with cholangiocarcinoma or ampullary carcinoma are~     suitable for surgical resection. The endoscopic or percutaneous transhepatic biliary drainage~     is accepted approaches for the relief of jaundice in malignant biliary obstruction. But~     restoration of bile flow have few improvement of the survival of cancer patient. By using~     endobiliary radiofrequency energy to destruct the tumorous tissue may delay tumour growth,~     which might improve the survival of patients. The feasibility and safety of this technique~     using HabibTM EndoHBP probe has been evident. The aims of this randomised, controlled,~     multicentre study is to evaluate whether endobiliary radiofrequency ablation(RFA) can improve~     the median survival of patients with unresectable biliary malignancy.~   "
131643|NCT01844232|"~     Clinical protocol OS440-3003 is a multicenter, open-label, non-randomized, uncontrolled, dose~     escalation study to evaluate the safety and tolerability of Arbaclofen Extended Release~     Tablets over 1 year in Multiple Sclerosis (MS) subjects with spasticity. All subjects in this~     study will receive arbaclofen in the extended release tablet formulation.~   "
131644|NCT01844219|"~     Acute kidney injury after cardiac surgery has been reported to increase morbidity and~     mortality. Several risk scoring models for prediction of aortic kidney injury after cardiac~     surgery have been developed. However, predictive accuracy of these models is stil unclear.~     The aim of this study is to evaluate the accuracy of four pre-existing prediction models~     using a gray zone approach in patients who underwent aortic surgery in our institution.~   "
131645|NCT01844206|"~     The investigators aim to assess the analgesic effect of a two-dose epidural morphine regimen~     for 2nd day post-cesarean pain, as part of a multimodal analgesia regimen, which includes~     scheduled Nonsteroidal anti-inflammatory drugs (NSAIDs). The investigators hypothesize that~     administration of a second dose of epidural morphine 3 mg, 24 hours after an initial~     intraoperative dose, will provide superior post-cesarean analgesia during the 2nd 24 hours~     after surgery, compared to a single epidural morphine dose regimen. The primary outcome will~     be the amount of intravenous morphine patients self-administer during the 2nd 24 hours~     post-surgery.~   "
131646|NCT01844193|"~     This study will examine the effects, if any, of using muscle stimulation on the quadriceps~     following a total knee replacement. Secondary objectives will be to evaluate and compare pain~     levels, qualitative outcomes, and the impact of NMES on pain medication requests between~     groups. It is possible that strengthening the quadriceps muscles and improving their~     activation will reduce postoperative pain and help patients return to activities sooner than~     with standard therapy alone.~   "
131647|NCT01844180|"~     The objective of this study is to explore efficacy, safety and tolerability of ONO-2952 in~     female subjects with Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D).~   "
131648|NCT01844167|"~     Chronic cervical pain is a common problem in rehabilitation clinic, but the treatment is time~     consuming and the effect unsatisfactory. Noxipoint® Therapy, developed by Dr. Charles C. Koo,~     is a unique electrical stimulation precisely on corresponding Noxipoints® of each injured~     soft tissue, with specific duration and intensity of TENS that induce C-fiber nerve ending~     sensation. Each application typically last for 2 to 5 minutes. Based on observations of the~     clinical application, Noxipoint® Therapy appears to relieve chronic neck and shoulder pain~     significantly with lasting effect, and effectively improves the range of motion. However,~     large-scale double-blinded, randomized control study on the therapy is not available yet.~      The purpose of this study is to compare the effect of Noxipoint® Therapy and physical therapy~     (including the current TENS application) on patients with chronic neck pain. This study is a~     prospective stratified randomized control trial. Eighty subjects with chronic cervical pain~     will be recruited from the Rehabilitation Department or the Physical Therapy Center of~     National Taiwan University Hospital (NTUH). The qualified subjects will be stratified and~     randomly allocated into two arms, 40 persons in each:~        1. Physical Therapy group (PT)~        2. Noxipoint Therapy group (NT) Subjects in either group will be treated for up to 6~          sessions within 3 weeks, about 1.5 hours per session. The treatment will terminate after~          six sessions or earlier if the patient shows no symptoms.~      Subjects will be evaluated before and after the first treatment session and followed up at~     about 4 weeks, 8 weeks, and 12 weeks after the first treatment.~      Outcome measures are (1) the pain scale in the Brief Pain Index, (2) cervical Range of Motion~     (ROM), (3) Quality of Life (QoL) measured with the Interference of Pain to Life section in~     the Brief Pain Index (BPI) and (4) ultrasound elastogram. Pain scale, ROM and QoL measures~     will be taken before and after the first treatment session, and at 4 weeks, 8 weeks and 12~     weeks after the first session. Elastogram will be taken before the first treatment, and about~     four weeks after the first treatment.~      Statistics: The effects of PT and NT will be compared based on two-sample hypothesis testing~     methods. All the estimated P-values are two tailed.~   "
131649|NCT01844154|"~     Osteoporosis is a prevalent health concern among older adults and is associated with an~     increased risk of falls that can cause fracture, injury or mortality. Identifying the factors~     related to falls occurring within this population is essential for the development of~     effective regimes for fall prevention. Studies have shown that muscle quality and good~     posture alignments are critical for balance control in older adults. People are diagnosed~     with osteoporosis often combining with muscles weakness, and increased spine kyphosis leading~     vertebral, fractures and poor balance control, even falls. Therefore, improving muscle~     quality, strengthening weak muscles and correcting postural alignment are essential elements~     for fracture and fall prevention in older adults with osteoporosis. The long-term objectives~     of this work are to prevent fracture and fall in older adults with osteoporosis by improving~     the function of degenerative muscles using exercise training.~   "
131650|NCT01844141|"~     To compare the efficacy of the lavage with 70% alcohol plus 0.5% chlorhexidine versus 70%~     alcohol in the surgical treatment of ingrown toenails.~   "
131688|NCT01843647|"~     The purpose of this study is to evaluate the overall response rate and disease free survival~     for IIIAN2 non-small-cell lung cancer patients with EGFR 19 or 21 exon mutation.~   "
131654|NCT01844089|"~     The broad objective of the study is to determine if the Bakri Postpartum Balloon is effective~     in preventing morbidity and mortality from postpartum hemorrhage (PPH) as part of a~     standardized management algorithm.~      Specific Objectives~        -  To estimate the rate of morbidity (including operative intervention and peripartum~          hysterectomy) and mortality secondary to PPH in 4 academic centers after introduction of~          a standardized protocol for management of PPH, but prior to the inclusion of the Bakri~          Postpartum Balloon as part of the protocol.~        -  To estimate the rate of morbidity (including operative intervention and peripartum~          hysterectomy) and mortality secondary to PPH in 4 academic centers after introduction of~          a standardized protocol for management of PPH, after the inclusion of the Bakri~          Postpartum Balloon as part of the protocol.~        -  To compare morbidity~        -  To generate preliminary data for (a) a larger confirmatory study of the use of the Bakri~          Postpartum Balloon in centers with surgical and blood transfusion services, and (b)~          design of a pilot study of the use of the Bakri device of temporary control of PPH in~          settings outside of surgical centers (such as by trained midwives or emergency transport~          personnel).~   "
131655|NCT01844076|"~     Establish the tolerability and safety of aimed dose of both quinacrine and capecitabine in~     combination to treat patients with advanced colorectal adenocarcinoma.~   "
131656|NCT01844063|"~     HBV-related liver failure (HBV-LF), a dramatic clinical syndrome, is characterized with~     massive necrosis of liver cells. Liver transplantation might be the most effective therapy~     for HBV-LF. However, there are a lot of problems such as lack of donors, surgical~     complications, transplant rejection, and high cost, which could limit the application of~     liver transplantation. It is demonstrated that mesenchymal stem cells could directionally~     differentiate into hepatocytes and cholangiocytes in injured liver, as well as reduce~     inflammation of the liver by immune regulation. In this study, we assess the safety and~     efficacy of human bone marrow and umbilical cord mesenchymal stem cells transplantation for~     patients with HBV-LF.~   "
131657|NCT01844050|"~     Based on the Individualized treatment of diabetes symptoms to evaluate the method of syndrome~     differentiation treatment of Traditional Chinese medicine.~   "
131658|NCT01844037|"~     This is a multi-center, prospective registry designed to monitor the outcomes of renal~     denervation with the OneShot Device in a real-world patient population.~   "
131659|NCT01844024|"~     Uganda is one of the countries with highest fertility rate in the world, 6.7 children per~     women. It is estimated that 56 percent of all pregnancies are unintended and the~     contraceptive prevalence rate in Uganda is 23 percent. Unwanted pregnancy is common and~     induced abortion is illegal. Unsafe abortion is responsible for significant morbidity and~     mortality among women in Uganda. Almost 40% of admissions to emergency obstetric care units~     in Uganda due to unsafe abortion is reported and considered high in international comparison.~     Studies have revealed that trained midlevel providers can deliver safe post abortion care~     (PAC) for incomplete abortion and use manual vacuum aspiration. The prostaglandin E1 analogue~     misoprostol has been shown to be an effective tool in the treatment of incomplete abortions.~     This option is so far under-used in developing countries, especially outside the larger~     hospitals and private clinics. One significant limiting factor in providing safe PAC is the~     lack of providers. So far technical training has been mainly limited to physicians. The~     long-term goal of this project is to provide evidence based information that will contribute~     to the development of strategies to increase women's access to high level post- abortion care~     at primary health care level provided by midlevel providers in Uganda. A task shift to~     midlevel provider in providing treatment of incomplete abortion will increase access to safe~     PAC and is a key to Millenium Development Goal 5. Misoprostol treatment of incomplete~     abortion remains underused and in accessible to a majority of women in Uganda because~     national regulations restricts its prescription and supervision to doctors. However, the~     safety of misoprostol treatment should make it amenable to provision by midlevel providers.~     Training of midlevel providers in misoprostol treatment of incomplete abortion will support~     task shifting in places where doctors are costly and scarce. By evaluating the effectiveness~     of mid-level providers (midwives); administering misoprostol treatment of incomplete abortion~     the project is attempting to contribute to the reduction of maternal mortality and morbidity~     and safeguard high quality of post-abortion care. A direct economic impact can also be~     expected due to reduced treatment costs of complications from unsafely induced abortion and~     incomplete abortions. The involvement of midlevel providers in medical treatment of~     incomplete abortion has previously not been systematically evaluated in African primary~     health care setting.~   "
131660|NCT01844011|"~     The purpose of the study is to find out the best way to help pregnant women keep track of~     their baby's movements. During pregnancy, feeling your baby's movements is normal. A decrease~     in movement can indicate potential problems with your baby's well-being. This study will see~     if daily electronic reminders and kick count charts help women to better track their baby's~     movements over the last weeks of pregnancy.~   "
131661|NCT01843998|"~     The purpose of this study is to determine whether sirolimus reduces the symptoms of cutaneous~     T-cell lymphoma (CTCL) and whether it causes any side effects.~   "
131662|NCT01843985|"~     Patients diagnosed with Stage IV cancer (solid tumors only) are evaluated to determine~     whether they are candidates for traditional chemotherapy. If eligible, patients are offered~     traditional chemotherapy, low-dose chemotherapy, or palliative care. If ineligible, patients~     are offered low-dose chemotherapy or palliative care. Patients will be monitored for 5 years~     and survival data recorded.~   "
131663|NCT01843972|"~     To investigate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of single~     rising doses of BI 691751 in healthy male subjects (part I).~      To investigate the relative bioavailability of BI 691751 given as tablet versus oral solution~     (part II)~   "
131664|NCT01843959|"~     A cross-sectional study investigating the aetiology, mechanisms and associated complications~     contributing to obesity and diabetes within the UAE population. The study will be carried out~     in two main sample populations; children and adults, and characterized by the occurrence of~     obesity and diabetes. The main samples will then be divided into a subgroup for metabolomic~     analysis. Patients will be recruited from the Imperial College London Diabetes Centre. The~     study is aimed at elucidating the various factors that have an impact or may influence~     obesity and diabetes in the Emirati population.~   "
131665|NCT01843946|"~     Roxithromycin is effective in the treatment of intracellular organisms, including chlamydia~     and mycoplasma, and exhibits anti-inflammatory and immunomodulatory effects on respiratory~     diseases. To explore the potential therapeutic benefit of roxithromycin in chronic~     prostatitis/chronic pelvic pain syndrome (CP/CPPS), this study compared the effect of~     roxithromycin with ciprofloxacin and aceclofenac.~   "
131689|NCT01843634|"~     This is an open-label pilot study evaluating the safety and preliminary evidence of a~     therapeutic effect of ODSH (2-0, 3-0 desulfated heparin) in conjunction with standard~     induction and consolidation therapy for acute myeloid leukemia.~   "
131768|NCT01842607|"~     This is a multi-centre, open-label long-term safety study of 100 milligram (mg) mepolizumab~     administered subcutaneously (SC) every 4 weeks for 12 months in addition to standard of care~     in subjects who have severe, refractory asthma and a history of eosinophilic inflammation.~     Subjects who completed either MEA115588 or MEA115575 will be offered the opportunity to~     consent for this study.~   "
131666|NCT01843933|"~     Background: Due to the lingering effects of general anesthesia and the administration of~     medications for pain after surgery, children in the recovery room are at risk for breathing~     problems. While there are less data specific to children, in general 25% of patients in the~     recovery room experience complications from anesthesia. The most common complications involve~     the patient's airway and their ability to breath adequately. Currently, checks of oxygenation~     with a pulse oximetry monitor and of respiration through nursing assessments are used to~     detect breathing problems. However, these are believed not to be adequate for reliably~     recognizing significant respiratory depression until other dangerous events develop such as~     the cessation of breathing, severe drops in oxygen levels, or cardiac arrest. Capnography is~     a monitoring device that measures the amount of carbon dioxide being exhaled and assesses the~     adequacy of respiration. A small plastic cannula sits at the base of the nose and on the lip~     to continuously monitor the patient's breathing. Most children tolerate this device well and~     staff consider it easy to use. While capnography is routinely used in the operating room to~     monitor breathing, it is not used during post-operative care when patients are still at risk~     of breathing problems.~      Objectives: To determine if capnography can detect problems with breathing faster and more~     often than traditional monitors. To determine if the addition of capnography to routine~     monitoring will decrease the numbers of additional adverse events that occur in children~     undergoing post-operative care by allowing nurses to intervene in care faster and more~     frequently.~      Methods: In the first phase of this study, the investigators will apply the capnography~     monitor to children in the recover room and determine how often they experience breathing~     difficulties measured by this device. In the second phase, the investigators will educate~     staff on the use of capnography and what values are considered abnormal. Children will again~     have the capnography cannula placed on them as they enter the recovery room. They will then~     be divided into two groups - in one group the nurses in the recovery room will have access to~     the capnography monitor for their patients, whereas in the other group the nurses will not be~     able to see the readout from the monitor. The investigators will determine if children have~     fewer breathing problems and less additional adverse events when nurses use capnography in~     addition to the routine monitors already in place in the recovery room as compared to when~     nurses use standard monitoring alone.~      Potential Impact: If capnography can detect breathing problems prior to being identified by~     current monitoring devices, staff may be able to intervene more quickly and before more~     serious events occur in the children receiving post-operative care. This can reduce adverse~     events, improve patient safety, and avert harm in children. The adoption of this device for~     routine monitoring of post-operative care has the potential to save lives.~   "
131667|NCT01843920|"~     A controlled clinical study comparing the effect of topical aqueous suppressants on~     intraocular gas duration.~   "
131668|NCT01843907|"~     Randomized Clinical Trial (RCT) To investigate and compare the effect of two preventive~     interventions on readmission rates, loss of functions, quality of life and cost-benefit.~   "
131669|NCT01843894|"~     Objectives:~      Primary~        -  To determine the safety and tolerability of escalating doses of RU-101 for 4 weeks in~          patients with severe dry eye~      Secondary~        -  To explore the efficacy of RU-101~        -  To explore optimal endpoints for future studies~   "
131670|NCT01843881|"~     The study is being undertaken to understand how the Roux-en-Y Gastric Bypass procedure can~     affect insulin secretion after meals. The hypothesis of this study is the Disposition Index~     is decreased in subjects who had previously undergone Roux-en-Y Gastric Bypass by~     glucagon-like peptide-1 (GLP-1) receptor blockade.~   "
131671|NCT01843868|"~     The incidence and severity of chemotherapy-induced nausea and vomiting (CINV) in patients~     receiving R-CHOP chemotherapy for in non-Hodgkin's lymphoma is not well documented. The~     contribution of prednisolone to CINV control in the R-CHOP regimen is also unclear.~      This study aims to evaluate the overall effectiveness of antiemetic control using a~     standardised 5HT3 (5-Hydroxytryptamine 3) antagonist-containing regimen (e.g. ondansetron) in~     a heterogeneous group of patients receiving R-CHOP chemotherapy (Rituximab Doxorubicin~     Vincristine Cyclophosphamide Prednisolone).~   "
131672|NCT01843855|"~     The study is being undertaken to understand how a gastric bypass can affect a subject's~     diabetes even prior to their losing significant amounts of weight. The hypothesis of this~     study is that increased glucagon-like peptide-1 (GLP-1) secretion explains the amelioration~     in insulin secretion after Roux-en-Y Gastric Bypass (RYGB) surgery.~   "
131673|NCT01843842|"~     The purpose of this study is:~        -  to assess safety of the liquid dosage form of Ergoferon for treatment of acute upper~          respiratory tract infections in children;~        -  to assess clinical efficiency of the liquid dosage form of Ergoferon for treatment acute~          upper respiratory tract infections in children.~   "
131674|NCT01843829|"~     About 7500 patients are diagnosed with oesophageal cancer each year in the UK of which less~     than a quarter have resectable disease at diagnosis. There is a general lack of consistency~     in the standard of care for patients across UK hospitals. Patients are either treated with a)~     chemotherapy followed by surgical removal of the tumour, or b) chemoradiotherapy followed by~     removal of the tumour by surgery, as part of their standard of care. Recent research supports~     the latter treatment, as chemoradiotherapy maybe more effective at shrinking the tumour and~     preventing the disease from spreading than taking chemotherapy alone. However, there is no~     definitive way of identifying which treatment is best without a clinical trial.~      Evidence suggests that the effect of the chemoradiotherapy currently used as standard~     practice may be improved and the side effects reduced by using a different chemoradiotherapy~     combination. In this trial, eligible patients will receive 2 cycles of the same chemotherapy~     before being randomised to receive two different chemoradiotherapy regimens (carboplatin and~     paclitaxel verses oxaliplatin and capecitabine) both of which have shown promising results in~     previous studies. Patients will then have their tumour removed. The best chemoradiotherapy~     regimen will then be taken forward to a Phase III trial in which chemoradiotherapy will be~     compared with chemotherapy alone.~      The efficacy of the regimens will be measured by counting the number of patients who i)~     remain free from cancer, ii)have local or distant spread of their cancer, iii) are~     successfully recruited and iv) experience toxicities. A specific set of toxicity criteria~     will be used to monitor any treatment induced side-effects and provide justification for any~     necessary dose modifications or withdrawal of treatment.~   "
131675|NCT01843816|"~     Tragus-to-wall distance (TWD) measurements is a method to evaluate spinal mobility in~     ankylosing spondylitis (AS) patients and it also takes place in Bath Ankylosing Spondylitis~     Metrology Index (BASMI). Being obese or slim may affect TWD. As well as the person's losing~     or taking weight may lead wrong evaluations, in comparative studies, according to the height~     or weight uneven distribution of groups may affect the results. The aim of this study is to~     investigate whether the body shape affect TWD or not.~   "
131690|NCT01843621|"~     The purpose of this study is to find out more about the two doses of dengue vaccine, over a~     five year period, that the children received in the Dengue-003 study and to study a third~     dose of dengue that will be given to the children~        -  Do children still have dengue antibodies intended to provide protection against dengue~          infection one year after the two doses of vaccine given in study Dengue-003?~        -  Were there any major medical problems that appeared as dengue-like symptoms during the~          one year after vaccinations?~        -  Will a third dose of dengue help to further stimulate the part of the immune system~          intended to help protect against dengue infection?~        -  Is a third dose as safe as the first two doses?~        -  Are the local reactions to a third dose of the vaccine similar to what your child~          experienced after the first two doses?~   "
131676|NCT01843803|"~     This study will use a multi-phase mixed-methods approach to develop and test a patient~     inventory to facilitate patient-centered care delivery. In Phase I the investigators will~     identify which factors should be considered for inclusion in the patient inventory. This will~     involve qualitative data collection with providers and patients using interviews and focus~     groups, respectively; and developing a question repository. The interviews and focus groups~     will take place at the six study sites: Hines VA Hospital and two Community Based Outpatient~     Clinics(CBOCs) in LaSalle, IL and Kankakee, IL; Jesse Brown VA Medical Center; and two CBOCs~     in Crown Point, IN; and Chicago Heights, IL. The question repository will involve a research~     assistant (RA) performing a literature review to gather items related to areas of patient~     context.~      Phase II will develop and test an item inventory using a Delphi panel - a panel of~     stakeholders including Veteran representatives, VA providers, researchers and representatives~     from the investigators' operations partners. The panel of at least 14 respondents will~     develop a questionnaire through three rounds of email exchanges ranking the list of items to~     be included in the patient inventory. Once the patient inventory is finalized, it will be~     integrated into an iPad application for patient use.~      In Phase III the investigators will test the patient inventory in a randomized trial.~      The investigators will conduct a randomized trial of the patient inventory to a control~     condition (e.g., healthy living video) to assess whether use of the inventory results in care~     that is more patient-centered and decisions that are more collaborative. Eligible~     participants will be identified and recruited from the Patient Aligned Care Team (PACT)~     clinics at Hines and Jess Brown VA facilities. Patients will be randomly assigned to either~     complete the patient inventory on the iPad or watch a health video on the iPad. Patients in~     the Intervention group will give a copy of the summary of the inventory to their provider.~     Both groups will be asked to carry a concealed tape recorder during their visit. Following~     the visit, patients in both groups will complete a set of questionnaires about the encounter~     including the CARE and CCM. The recordings will be analyzed by the team using a coding system~     developed in a previous Health Services Research and Development (HSR&D) study to see if the~     use of the patient inventory facilitated patient-centered care during the encounter. A second~     coding scheme, the Informed Decision Making (IDM) will also be applied to examine~     collaborative decision making.~   "
131677|NCT01843790|"~     The primary objective of this study is to compare the change in estimated glomerular~     filtration rate (eGFR) from baseline to Week 8 between placebo and GCS-100 treatment. The~     secondary objective is to determine the safety and tolerability of GCS-100 administered for 8~     weeks relative to placebo. In addition, the study will measure the effect of GCS-100 on~     circulating galectin-3 and other markers of disease activity.~   "
131678|NCT01843777|"~     The purpose of this study is to compare two different ways of helping first-time hearing-aid~     users get the most out of their hearing aids and determine if one method is better than the~     other. One method provides the patient with routine information regarding the care and use of~     hearing aids the other method uses tools to address patient-specific barriers against and~     motivators for hearing-aid use.~   "
131679|NCT01843764|"~     The aim of the study was to follow clearance of malaria infections and detection of new~     malaria episodes after initiation of antimalarial treatment in Tanzanian children. For this~     purpose the investigators used five diagnostic tools, 2 Rapid Diagnostic tests based on~     Histidine Rich Protein 2(HRP2) and Lactate dehydrogenase(LDH), 2 microscopical methods and~     one polymerase chain reaction (PCR). The investigators followed the 53 enrolled children~     during 42 days.~   "
131680|NCT01843751|"~     The proposed work addresses critical health and public safety issues in the U.S. and in~     Wisconsin: the intersection of addiction and crime and the prevention of associated~     individual and public health complications. The results will provide justification for the~     expanded involvement of primary care in the treatment of substance-related disorders (opioid~     dependence in particular) and the prevention of their complications. As such, the project~     answers to federal calls for the expansion of substance abuse treatment into primary care~     settings and to objectives within the Alcohol and Drug Focus Area of Healthiest Wisconsin~     2020.~   "
131681|NCT01843738|"~     Patients are being asked to take part because they have melanoma that has spread to other~     organs in their body (metastatic). As part of this study, patients will receive radiation~     therapy and an approved drug (Vemurafenib).~   "
131682|NCT01843725|"~     Prospective non randomized, non-comparative, dose escalation, two arms open phase I trial to~     assess the safety and tolerability of capecitabine given in combination with aflibercept in~     patients with measurable or evaluable, chemorefractory digestive tumors or breast tumors in~     terms of the Maximum Tolerated Dose (MTD) and the Dose-Limiting Toxicities (DLTs), To~     establish the Recommended Phase II Dose (RP2D) of capecitabine in combination with~     Aflibercept.~   "
131683|NCT01843712|"~     Objectives: The aims were to measure caloric compensation (CC) and eating in the absence of~     hunger (EAH) in 2 to 7 year-old French children in their regular eating context and to link~     these measurements with individual characteristics (adiposity, age, gender) and parental~     feeding practices.~      Design: Three consecutive weeks an identical lunch was served in four preschool canteens~     reaching 236 children. The first lunch was a control session. For the CC situation (week 2),~     thirty minutes before the lunch children were offered a preload (137 kcal). For the EAH~     situation (week 3), ten minutes after lunch children were exposed to palatable foods (430~     kcal). Food intake was measured at the individual level. Parental eating behaviour and~     feeding practices were measured by questionnaires. Child's height and weight were measured by~     a medical doctor.~   "
131684|NCT01843699|"~     Objectives: Pathological gambling (PG) is a prevalent disorder with no approved~     pharmacological treatment. Previous reports suggest that topiramate could be useful in~     reducing impulsivity in PG, and craving in other addictions. The goal of this study was to~     investigate the effectiveness of topiramate combined with brief cognitive restructuring in~     treating PG. Methods: 38 PG patients were randomized to either topiramate (N=18) or placebo~     (N=20) in a 12-week double-blind trial; all patients received brief cognitive restructuring.~     The main outcome measures were craving, gambling behaviour, gambling cognitive distortions,~     impulsivity, depression and social adjustment.~   "
131685|NCT01843686|"~     This study will demonstrate the safety of the application of autologous platelet rich plasma~     (PRP) gel following excision and autologous skin grafting of acute deep 2nd and 3rd degree~     burns. The study will be a randomized, double-blinded controlled safety study. Investigators~     expect that the PRP will deliver improved hemostasis and growth factors at the wound site~     thus increasing the effectiveness of treatment at the wound site. This will lead to rapid~     production and delivery of an autologous therapy that should minimize additional morbidity to~     the patient.~   "
131686|NCT01843673|"~     This clinical trial studies image-guided adaptive radiotherapy in detecting tumors during~     treatment in patients with head and neck cancer. Image-guided adaptive radiotherapy uses high~     quality imaging technology to detect the tumor and normal organs during treatment. It is not~     yet known which imaging technique provides the best image for guidance during treatment with~     radiation therapy. Comparing results of imaging procedures done before, during, and after~     radiotherapy may help doctors plan the best treatment.~   "
131691|NCT01843608|"~     Breast cancer survival it is affected by the side effects related to the illness, the~     treatments or even the behavioral factors (e.g. inadequate diet, sedentary behavior) that~     create in this women an important quantity of psychological and physical disorders. Prior~     systematic reviews and meta-analyses have demonstrate that supervised aerobic training is a~     safe, feasible, and effective adjunct therapy to improve a broad range of physiological and~     psychological outcomes in women with early breast cancer. However the vast majority of~     studies to date have focused on the efficacy of exercise to improve symptom control outcomes~     in breast cancer patients either during or following the completion of adjuvant therapy.~      Most relevant consequences are found in women that have to undergo surgery as 16% to 43% of~     women with breast cancer suffer functional limitation in the shoulder, inflammation, pain or~     strength and flexibility reduction in upper body limbs one year after surgery with a high~     prevalence which is rising.~      Weight gain is associated with decreased quality of life and increased risk for several~     comorbid conditions, such as cardiovascular disease and diabetes. The most of the~     cardiopulmonary problems are induced by chemotherapy or radiotherapy, because of the~     treatments effect in the heart and its consequences in cardiorespiratory fitness of these~     women.~      These side effects become in important limitations to allow women return their normal life~     style. These limitations have a severe effect in decreasing of physical activity practice,~     which have visible consequences in increasing general fatigue and calcium deficiency in bones~     due to the age and some adjuvant treatments.~      Previous studies found that patients with breast cancer who gained modest amounts of weight~     were significantly more likely to experience disease recurrence and die from breast cancer~     and other causes that those who were weight stable. In addition, two thirds of the studies~     that have assessed body composition change in relation to weight gain in this patient~     population observe no net gain in muscle mass or loss in muscle mass as body weight and~     adipose tissue increase. These changes are defined as sarcopenic obesity. This kind of~     obesity is characterized by weight gain in the presence of lean tissue loss or absence of~     lean tissue gain. In addition fat tissue gain is related with other health disorders such as~     diabetes, functional limitations and poor survival levels. Treatment for this unique pattern~     of weight gain is an exercise intervention, especially strength training.~      Psychological effects have to be took account as cancer produce important aftermath. Large~     scientific evidence shows the psycho-emotional alterations in women diagnosed with breast~     cancer at some point in their life.~      World Health Organization (WHO) defines quality of life as individuals perception of their~     position in life in the context of the culture and value systems in which they live and in~     relation to their goals, expectations, standards and concerns. It is a broad ranging concept~     affected in a complex way by the person's physical health, psychological state, level of~     independence, social relationships, personal beliefs and their relationship to salient~     features of their environment. Following this definition numbered of researches have been~     developed, presenting interest in both physiological and psychological changes and~     improvements, as show different studies.~      HYPOTHESIS The primary hypothesis of this study is that group exercise intervention,~     combining aerobic and strength training, will reduce lean mass and body fat tissue in breast~     cancer post treatment survival.~      Secondary hypothesis of this clinical trial are follows:~        1. Combined exercise intervention will increase maximal strength level of chest press and~          leg press.~        2. Combined exercise intervention will increase maximal cardiopulmonary capacity, assessed~          by Peak Oxygen Consumption(VO2peak), which has been confirmed as an important value in~          survivals. In addition, ACSM propose this value as the Gold Standard to assess fitness~          level.~        3. Combined exercise intervention will increase global Isometric Strength Index, assessed~          by Grip Strength Dynamometer.~        4. Combined exercise intervention will improve range motion in upper-limbs.~        5. Patients Reported Outcomes (PROs), such as quality of life (QoL), Health perception and~          depression.~   "
131769|NCT01842594|"~     Determine the objective response rate in sarcoma patients treated with hydroxychloroquine and~     sirolimus.~   "
131692|NCT01843595|"~     The purpose of this study is to test the effect of a new three-month behavioral weight loss~     program among adult men. Weight will be measured at three and six months post randomization.~     The intervention will be compared to a wait-list control group. Participants will be 112~     overweight and obese men (18-65) living in the Chapel Hill/Raleigh/Durham area. The~     behavioral intervention tested will be delivered online with two face-to-face group meetings.~     Intervention content will be delivered via email and online. It is hypothesized that men~     randomized to the REFIT intervention will lose more weight at 3 months than men randomized to~     the wait-list group.~   "
131693|NCT01843582|"~     The study is aimed to develop a new reaction-time based method for examining the visual field~     and to study the effect of refractive error on the magnification of a fundus photograph in~     order to evaluate the true size of a retinal feature.~   "
131694|NCT01843569|"~     We hypothesize that the combination of natural cycle IVF or low dose gonadotropin injection~     combined with In Vitro Maturation (IVM) (Natural IVF/IVM) is a viable option for a selected~     population of infertility patients who cannot tolerate exogenous gonadotropins or are at risk~     of ovarian hyperstimulation syndrome.~   "
131695|NCT01843556|"~     A phase 1 study of E2022 tape formulation in healthy elderly males to evaluate the safety and~     pharmacokinetics.~   "
131696|NCT01843543|"~     Urgency Incontinence (where the bladder muscles contract suddenly, causing an immediate urge~     to urinate that is difficult to prevent) is commonly experienced in patients with overactive~     bladder. New findings have discovered that urgency incontinence may be connected to the~     interactions of certain regions of the brain and the bladder. Although this is a common~     problem, researched still do not know how these interactions impact the process of urgency~     incontinence. Furthermore, there is preliminary data to suggest that interventions such as~     Mindful-Based Stress Reduction (MBSR) can potentially be used as therapy for UI. The purpose~     of this study is to determine the impact MBSR training on UI symptoms, quality of life, and~     anxiety measures.~   "
131697|NCT01843530|"~     This trial is a randomized, double-blind, two arms, multicenter, Phase III study of Berinert~     for treatment of ACE induced Angioedema.~      This study should show that Berinert shortens the time to complete resolution of signs and~     symptoms of acute ACE-induced angioedema of the upper airway tract compared to placebo when~     given on top of standard treatment. This study should also compare the time to onset of~     relief as defined by an at least one point reduction on the severity scale of ACE-induced~     angioedema with Berinert versus placebo.~   "
131698|NCT01843517|"~     This study seeks to further understand these three observations - (1) that the time period~     surrounding childbirth accelerates recovery from pain after injury (2) that this likely~     reflects dampened facilitating mechanisms and exaggerated inhibitory mechanisms, and (3) that~     stress may interfere with this protection. In this study the investigators will compare women~     within 2 weeks of delivery to age matched controls and anticipate that pain inhibition is~     increased after delivery, pain facilitation is decreased, and that there is a relationship~     between these pain responses and the degree of pre-existing stress.~   "
131699|NCT01843504|"~     The goal of this study is to find an effective treatment for chronic patellar tendinopathy~     (PT). Investigators will conduct a 32-week randomized controlled clinical trial to determine~     whether platelet rich plasma (PRP) injections improve disease-specific clinical outcomes with~     correlation to a new method of ultrasound (US) imaging assessment called Acoustoelastography~     (AE). Positive findings of PRP compared to control would suggest future larger scale studies~     to help establish an optimal protocol for the nonsurgical management of PT.~   "
131700|NCT01843491|"~     This is an open label Phase 1 study of the Ad-PfCA vaccine designed to 1) provide reagents~     for the development and refinement of cell-mediated immunoassays for measuring the human~     immune response to candidate malaria vaccines (especially protective malaria vaccines such as~     DNA/Ad-PfCA where better assays are needed to identify the correlates of protective immunity)~     and 2) to provide a repository of antigen-specific PBMCs that can be used as positive and~     negative controls in cell mediated immunoassays.~   "
131701|NCT01843478|"~     Cervical cancer is the second most common type of cancer among women worldwide. Women with~     human immunodeficiency virus (HIV) bear a disproportionate burden of cervical cancer and its~     precursor, cervical intraepithelial neoplasia (CIN), that result from persistent high-risk~     Human Papillomavirus (HPV) infection. HIV clinical practice guidelines recommend two Pap~     tests in the year following diagnosis, and if both are normal, yearly thereafter. Nationally,~     only 25% of women meet this recommendation. The mean annual Pap testing rate for federally~     funded HIV centers is only 55.7%. In 2009, quality improvement statistics from the Johns~     Hopkins Hospital Moore Clinic, a large urban HIV center, revealed an annual Pap testing rate~     of 59%. This occurred despite interventions to address adherence issues were implemented,~     including nurse case management, co-location of HIV and gynecology services, flexible~     scheduling, and continuity of care. Women keep their appointments for HIV primary care more~     often than for gynecology care in the Moore Clinic, so an intervention that takes place~     during a primary care visit could improve cervical cancer screening rates.~      The availability of HPV testing provides a unique opportunity to increase perceived~     susceptibility to and severity of cervical cancer among women with HIV, and to encourage~     follow-up Pap testing. HPV testing involves analyzing a sample of cervicovaginal cells for~     the presence of high-risk HPV strains. Detection of high-risk strains of the virus indicates~     a high risk for high grade CIN and cancer, while a negative HPV test predicts a less than 2%~     risk of developing CIN. HPV testing can be easily conducted by women themselves through~     self-collection in a primary care visit. Studies of women without HIV who do not have regular~     Pap testing have demonstrated that self-collected HPV testing and results counseling~     increases the overall screening rate, and women who test positive for HPV have a high rate of~     follow-up Pap testing. Self-collected HPV testing and results counseling could be utilized in~     the HIV primary care setting to promote Pap testing among women with HIV.~   "
131702|NCT01843465|"~     According to data from high volume Centres, documentation of entry block with the Achieve~     catheter may be possible in only about to 50% of pulmonary veins. The investigators aim to~     assess strategies using the Achieve catheter that can improve this performance.~   "
131703|NCT01843452|"~     There is increasing evidence of a role of EGFR, treatment with EGFR-inhibitors in anal cancer~     and synergies of EGFR-inhibitors with radiotherapy. Addition of the human anti-EGFR antibody~     Panitumumab to chemoradiotherapy seems therefore solidly justified. This trial investigates~     concurrent panitumumab/capecitabine/mitomycin concurrent to IMRT-radiotherapy. Treatment~     components used in this study have been selected on scientific rationale. The trial regimen~     should be feasible with acceptable toxicity and outcome similar to historic series.~   "
131770|NCT01842581|"~     The purpose of the study is to evaluate if Rifaximin alone or Rifaximin plus Lactulose delays~     the onset of hepatic encephalopathy (HE) in cirrhotic subjects who have had a previous~     episode of HE.~   "
131704|NCT01843439|"~     We want to examine the effect of multidisciplinary interventions in asthma patients who had~     experienced acute exacerbation of asthma.~      In our previous observational studies, elderly asthma patients had a some distinct features~     such as impairment of cognitive function, deficiency of micronutrient and absence of~     caregiver compared with young adult asthmatics.~      We wanted to evaluate whether the long-term course of asthma could be modified by intervening~     deficienies which were found in elderly patiensts.~      So, we designed a interventional study to correct above risk factors in elderly asthma~     patients, which could be aggravating their asthma. Followings are our specific~     multidiciplinary items that we want to correct.~        1. popularize and educate the asthma action plan~        2. run a emergency call system for acute exacerbation~        3. educate the proper techniques using inhalers~        4. correct the deficiency of magnesium (magnesium 500 mg per day)~      After 1 years, we will measure the numbers of acute exacerbations, lung function including~     FEV1 and FEV1/FVC, health-related quality of life and level of serum magnesium in study~     patients.~   "
131705|NCT01843426|"~     The purpose of this study is to evaluate contrast media volume, safety and 30-day outcome of~     patients after a computed tomography (CT) scan. The results of this study will help to~     determine the minimum volume of contrast material that can be used to ensure patient safety~     while not compromising diagnostic image quality in high-risk patients.~   "
131706|NCT01843413|"~     This phase I/II trial studies the side effects and the best dose of stereotactic radiosurgery~     and to see how well it works in treating patients with large brain metastases. Radiosurgery~     can send x-rays directly to the tumor and cause less damage to normal tissue.~   "
131707|NCT01843400|"~     This study is a regulatory post-marketing surveillance in Japan, and it is a local~     prospective and observational study of patients who have received Regorafenib for colorectal~     cancer.~      The objective of this study is to assess safety and effectiveness of Regorafenib using in~     real clinical practice.~      A total of 1,250 patients are to be enrolled and assessed in 6 months standard observational~     period. At 12 months after the first administration of Regorafenib for confirmation of~     efficacy information including treatment duration and survival status of the patient.~   "
131708|NCT01843387|"~     The study investigates the safety, tolerability and efficacy of a single intravenous infusion~     of two doses of mesenchymal precursor cells versus placebo in subjects with diabetic~     nephropathy and type 2 diabetes.~   "
131709|NCT01843374|"~     This is a Phase 2b, randomized, double-blind, parallel-group study. Subjects with~     unresectable pleural or peritoneal malignant mesothelioma will be randomized in a 2:1 ratio~     to receive either tremelimumab or placebo. Approximately 564 subjects will be enrolled at~     study centers in multiple countries. The study consists of a screening period, a treatment~     period, a 90-day follow-up period for safety, and a long-term survival follow-up period.~   "
131710|NCT01843361|"~     The aim of this study was to determine the prevalence rate and risk factors for chemical~     laboratory clopidogrel low-response (CLR) in the acute phase after an ischemic stroke.~   "
131711|NCT01843348|"~     This study was designed to evaluate the renal function comparing Certican based~     immunosuppressive regimens with two different CNIs (Tacrolimus or Cyclosporin A) versus a~     standard treatment with Mycophenolic Acid and Tacrolimus in de novo renal transplant~     recipients.~   "
131712|NCT01843335|"~     X-ray computed tomography imaging (CT) is routinely used in follow-up after endovascular~     aneurysm repair (EVAR). Contrast-enhanced ultrasound (CEUS) has been shown to give accurate~     information about endoleak after EVAR. Benefits of CEUS over CT include less radiation~     exposure, avoidance of renal function deterioration due to repeated X-ray contrast agent~     application and decrease in the cost of EVAR follow-up. This study is designed to investigate~     if results from literature are reproducible in St Olavs Hospital in Trondheim (Norway), to~     gain experience with the technique and to introduce CEUS as an alternative for detection of~     endoleak in this hospital.~   "
131713|NCT01843322|"~     The study is aimed at investigating whether repair of endoleak type II can be improved by~     adding navigation technology. Can this technology increase precision by guiding the needle~     that punctures through the skin as used during the repair procedure? Can the procedure~     logistics be improved by using navigation technology instead of computed tomography (CT)~     guidance of the needle puncture? Parameters logged during the procedure:~        -  was the needle placement successful?~        -  number of needle punctures?~        -  time used on guidance procedure~        -  X-ray exposure dose~   "
131714|NCT01843309|"~     Purpose Invasive fungal infections cause significant morbidity and mortality in~     immunocompromised patients.~      Amphotericin B deoxycholate (AmB) is a polyene antifungal agent. The broad spectrum of~     activity contributed to it being considered the gold standard of antifungal therapy despite~     being associated with high incidences of infusion related adverse events.~      AmB exerts their antifungal effect binding to ergosterol; a sterol similar to cholesterol~     found in fungal cell membranes. However AmB also binds to cholesterol molecules in mammalian~     cell membranes forming intramembranous pores and vacuoles in the distal convoluted tubule of~     the kidney producing its nephrotoxic effects.~      Nephrotoxicity is the major adverse effect of AmB, often limiting administrations of full~     dosage; it's manifested as acute kidney injury, impaired renal concentrating ability,~     augmented urinary potassium secretion through tubular Na+/K+ ATPase, type-1 renal tubular~     acidosis, which increases the elimination of potassium, and magnesium wasting. Furthermore~     potassium depletion potentiates the tubular toxicity of AmB.~      The management of potassium wasting may be difficult, even high intravenous doses of~     potassium chloride may not be fully effective in correcting the hypokalemia. It has been~     probed the use of potassium-sparing diuretics to limit electrolyte wasting in patients~     treated with AmB.~      In 1988 Smith et al, demonstrated that amiloride was well tolerated and provided effective~     control of plasma potassium in patients treated with AmB. This finding was confirmed in 2001~     by Bearden et al. However in our country the only available commercial presentation of~     amiloride also contains hydrochlorothiazide, limiting its use in such patients.~      Spironolactone acts on the distal renal tubule by competitive inhibition of aldosterone,~     thereby blocking the exchange between sodium and both potassium and hydrogen in the distal~     tubules and collecting ducts. These agents produce a sodium diuresis which results in~     potassium retention. There is only one clinical trial by Ural et al, using spironolactone to~     prevent hypokalemia in twenty-six neutropenic patients on AmB treatment; they demonstrated~     that those patients receiving concomitant AmB and spironolactone (100mg bid) had~     significantly higher plasma potassium levels than those receiving AmB alone (P=0.0027) and~     required significantly less potassium supplementation to maintain their plasma potassium~     within the normal range (P=0.022).~      Renal vasoconstriction appears to play a major role in AmB induced reduction in GFR;~     recurrent ischemia may lead to structural and tubular damage and permanent nephrotoxic~     effects.~      Aldosterone modulates the tone of the renal vasculature. Bobadilla et al have shown in animal~     models of cytotoxic damage using cyclosporine; that a mineralocorticoid receptor blockade~     with spironolactone reduces the structural renal damage, and also prevents renal dysfunction~     due to afferent and efferent vasoconstrictions. This group has also shown that prophylactic~     treatment with spironolactone completely prevents renal dysfunction and histological signs of~     tubular injury from ischemia-reperfusion injuries. And also has demonstrated the ability of~     spironolactone in animal models to protect the kidney after establishing an ischemic insult,~     when spironolactone was administrated immediately or 3h after the renal ischemic insult had~     occurred, reducing levels of sensitive biomarkers such as Kim-1 and Hsp70.~      The investigators' hypothesis is that administration of spironolactone in patients treated~     with AmB will help to maintain significantly higher plasma potassium levels and will help to~     reduce potassium and magnesium supplementation. Moreover spironolactone will help to reduce~     the urinary excretion of potassium.~      The investigators propose a randomized, double blind, placebo controlled trial approved by~     the local ethical committee, to compare the efficacy and security of spironolactone to reduce~     electrolytic derangements in three groups: AmB and placebo, AmB and spironolactone 100mg once~     a day, AmB and spironolactone 100mg twice a day. The investigators will include 12 patients~     per group. Researchers will collect daily plasma creatinine, sodium, potassium, BUN and~     urinary potassium, as well as the values of potassium and magnesium supplements administered~     orally or parenterally. The researchers will also collect by 7 days urinary levels of NGAL,~     KIM-1 and Hsp-70 as tubular injury markers.~   "
131715|NCT01843296|"~     The purpose of this study is to Compare three methods of intrathecal bupivacaine;~     bupivacaine-fentanyl; bupivacaine-fentanyl-magnesium sulfate on sensory-motor blocks and~     postoperative pain in patients undergoing lumbar disk herniation surgery.~   "
131716|NCT01843283|"~     The purpose of this pilot study is to evaluate the feasibility of and satisfaction with the~     revised DEMA and to estimate effect sizes for DEMA through incorporation of a comparison~     group. Specific aims are as follows:~      Aim 1: Evaluate feasibility of the study for MCI patient/caregivers. Aim 2: Estimate effect~     sizes for DEMA on MCI patient and caregiver outcomes. Aim 3: Evaluate MCI patients and family~     caregivers' satisfaction with and perceptions of DEMA or IS.~   "
131717|NCT01843270|"~     The classic laryngeal mask airway is one of the keystones of modern anaesthetic practice. It~     achieves a reliable airway with a low incidence of major complications and~     pharynges-laryngeal morbidity. The manufactures of laryngeal mask airway recommend the proper~     size selection by actual body weight. It was recommended a size 3 for 30-70kg, a size 4 for~     70-90 kg, and size 5 for > 90 kg. Obesity increases the fat tissue around an upper airway and~     decreases the pharyngeal cross sectional area. Also it was reported that pharyngeal area was~     reduced according to the increasing of BMI. Therefore, the aim of this study is to determine~     which of actual body weight or ideal body weight is proper on the size selection of laryngeal~     mask airway.~   "
131718|NCT01843257|"~     The investigators wish to study the effects of three forms of bariatric surgery: gastric~     bypass, sleeve gastrectomy, and lap banding. The surgery is not part of the clinical trial.~     If insurance does not cover the procedure, then the patient is responsible for payment of the~     surgical process. The investigators are doing pre- and post-surgery testing to provide a~     better understanding of the effect of bariatric surgery-induced weight loss on 1) alcohol~     absorption, distribution and elimination from the body; 2) the effects of alcohol on blood~     sugar; and 3) the effects of alcohol on mood.~   "
131722|NCT01843205|"~     Methamphetamine use disorders are an unrelenting public health concern. Intensive research~     efforts have yielded behavioral interventions that reduce methamphetamine use, however, these~     interventions are not universally effective and treatment effects diminish over time.~     Development of a pharmacotherapy that enhances the efficacy of these interventions is a~     priority for the National Institute on Drug Abuse. This study proposes to determine the~     impact of buspirone maintenance on self-administration of methamphetamine. These preliminary~     data will be used to support further research developing buspirone as a pharmacotherapy for~     methamphetamine use disorders. The investigators hypothesize that buspirone will attenuate~     the reinforcing effects of methamphetamine.~   "
131723|NCT01843192|"~     This study aims to collect real world outcomes of Video-Assisted Thoracoscopic Surgery (VATS)~     for lung cancer (lobectomy, wedge resection) using ECHELON FLEX™ Powered ENDOPATH® Staplers~     45 mm and/or 60 mm (study devices).~   "
131724|NCT01843179|"~     This research study is a Phase II clinical trial. Phase II clinical trials test the~     effectiveness of an investigational drug to learn whether the drug is effective in treating a~     specific cancer. Investigational means that sulindac is still being studied and that~     research doctors are trying to find out more about it. It also means that the FDA has not yet~     approved the use of sulindac for your type of cancer.~      Participants in this study must have undergone previous chemotherapy and achieved complete~     remission, which is the absence of disease activity in people with a chronic illness, in this~     case AML. Unfortunately, a significant number of patients with AML who achieve a complete~     remission with initial chemotherapy eventually experience a relapse, often within a few~     months.~      Previous research studies have demonstrated that a type of medication frequently used to~     treat inflammation, called a COX inhibitor, may suppress and kill leukemia cells. COX~     inhibitors work by blocking a class of proteins called COX proteins. Other commonly used COX~     inhibitors are ibuprofen and naproxen.~      For this study, the investigators are using a COX inhibitor called sulindac, which has been~     FDA approved and used to treat pain and inflammation for many years, and has also been~     studied in suppressing certain tumors of the gastrointestinal system. The main goal of this~     study is to determine whether sulindac can help participants remain in a state of complete~     remission following the initial course of chemotherapy for AML, and two cycles of~     chemotherapy that is standard of care for your cancer, called consolidation chemotherapy.~     During the course of this study, the investigators will also attempt to learn more about how~     COX inhibition suppresses the emergence of leukemia, at the molecular and cellular level, by~     studying the participants on this trial.~   "
131725|NCT01843166|"~     Patients presenting with pelvic organ prolapse will be offered the use of a pessary. Vaginal~     estrogen cream treatment with the pessary will be randomized amongst the patients and patient~     satisfaction and complication rates will be assessed during follow-up.~   "
131726|NCT01843153|"~     The role of a sciatic block in addition to a femoral block remains controversial. The study~     addresses this topic by comparing a continuous block versus an injection on demand.~   "
131727|NCT01843140|"~     The FIRST project is a national fertility preservation registry for young women facing cancer~     treatments. The investigators will examine how different cancers and treatments affect the~     reproductive health of young survivors. This prospective cohort study seeks to recruit young~     women close to time of cancer diagnosis and treatment. Participants will answer a yearly~     questionnaire on their current health. A subset of participants will provide dried blood~     spots to measure reproductive hormones. The primary goal of the study is to determine the~     risk of infertility and time to pregnancy in young female cancer survivors.~   "
131728|NCT01843127|"~     To explore the mechanism of action of ranolazine as a potential treatment for type 2 diabetes~     mellitus (T2DM).~   "
131729|NCT01843114|"~     The prevalence of diabetes and diabetes-associated complications is still increasing. Several~     major long-term complications of diabetes such as cardiovascular disease, chronic renal~     failure, diabetic retinopathy and others relate to the damage of blood vessels. Given that~     the eye provides the unique possibility in the human body to directly visualize blood~     vessels, much interest has been directed towards studying the ocular circulation. Although~     data of large epidemiological studies indicate that changes in retinal vessel caliber reflect~     other diabetes related factors, such as fasting glucose levels, there is still conflicting~     evidence on blood flow alterations in patients with diabetes. This is also related to the~     fact that up to now, methodological difficulties aggravate the assessment of blood flow~     changes in the retina in larger groups of patients. In the present study we propose to~     overcome this problem by using a technique called bi-directional Fourier Domain Doppler~     Optical Coherence Tomography (FDOCT), which we have developed in the recent years to measure~     retinal blood velocities. This technique allows for the non-invasive investigation of blood~     flow changes in human retina and will help us to better understand diabetes related vascular~     changes. The present study will use this technique to assess retinal blood flow changes in~     patients with diabetes and healthy subjects.~   "
131730|NCT01843101|"~     The aim of the present study is to develop a protocol for optimal corneal 3-dimensional~     imaging based on measurements in healthy volunteers. For this purpose, a customized~     ultra-high resolution Spectral Domain OCT will be used. To validate whether the protocol can~     also be applied in patients with corneal pathologies, for whom it is intended to be used,~     measurements in these patients will be performed. We propose to obtain images from patients~     with keratoconus, since this is one of the most frequent causes for corneal transplantations~     in Europe and from patients with corneal neovascularization which is a major cause of vision~     loss in several ophthalmic diseases. Based on the obtained measurement protocol, further~     studies investigating the pathophysiology or treatment success of several corneal pathologies~     can be planned.~   "
131731|NCT01843088|"~     Mannitol cream has been shown clinically to be effective for pain control. To determine if~     this effect is worth testing on a larger scale, 170 runners will receive a sample of 25%~     mannitol cream to apply on one leg, and the cream base without the mannitol on the other leg~     following a 10 km or longer run, and for the following five days. Mannitol and control legs~     will be chosen at random for each runner. Pain scores before and after cream application will~     be acquired each day for each leg. Means and standard deviations found will be used to~     determine the size of a larger study.~   "
131732|NCT01843075|"~     This is a 12-month, multicentre randomised double-blind placebo-controlled Phase IIb study in~     patients with mild Alzheimer's dementia (AD). The investigators aim to recruit patients with~     mild Alzheimer's dementia as defined by the National Institute of Neurological and~     Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorder Association~     (NINCDS-ADRDA) Criteria for Probable Alzheimer's Dementia or meeting Dubois criteria for~     early AD, with Mini Mental State Evaluation score of at least 20 out of a maximum of 30 and a~     CDR Global score of 0.5 or 1.~      Patients will be randomised on a 1:1 ratio to receive liraglutide or matching placebo.~   "
131734|NCT01843049|"~     Most local failures after definitive chemoradiation for unresectable esophageal cancer occur~     in the gross tumor volume (GTV). And the metabolic active areas post-treatment were located~     in the high FDG uptake areas prior to the radiotherapy. The hypothesis is that selective dose~     boost to the esophageal GTV could be safely delivered using a simultaneous integrated boost~     (SIB) technique, and that boosting the high 18F-deoxyglucose (FDG) uptake areas of the~     esophageal GTV defined prior to treatment may improve local tumor control.~   "
131735|NCT01843036|"~     The aim of this randomized controlled trial (RCT) is to conduct a second, independent~     evaluation the implementation and impact of the Durham Connects (DC) brief universal nurse~     home-visiting program to prevent child maltreatment and improve child and family health and~     well-being. Durham Connects is the first home-visiting program that is designed to prevent~     child maltreatment and improve health and well-being outcomes in an entire community~     population.~      Program evaluation will test four hypotheses: 1) The program can be implemented with~     population reach, fidelity to the manualized intervention protocol, and reliability in~     assessment of family risk; 2) Random assignment to the Durham Connects program will be~     associated with lower rates of child maltreatment and emergency department~     maltreatment-related injuries, better pediatric care, better parental functioning, and better~     child well-being than assignment as control; 2) Intervention effect sizes will be larger for~     higher-risk groups; and 3) Community resource use and enhanced family functioning will~     mediate the positive impact of Durham Connects on outcomes.~   "
131736|NCT01843023|"~     The purpose of this study is to compare 6-month treatment outcomes for 15-21 year old~     opioid-dependent youth receiving extended release naltrexone (XR-NTX) v. Treatment as Usual~     (TAU).~   "
131737|NCT01843010|"~     This prospective, double blind, placebo-controlled, parallel group study will be conducted in~     the first affiliated hospital of Sun yat-sen university in Guangzhou, China. Patients aged~     18-65 (ASA I-II) undergoing elective gynecologic laparoscopic surgery with general anesthesia~     will be involved in this study. According to previous studies and our pilot trial, estimated~     120 patients will be involved in this study. All eligible patients will be randomly assigned~     to two groups. In group P, patients will receive parecoxib 40mg intravenously 30min before~     intubation, 8h and 20h after the surgery,respectively. In Group C, patients will receive~     normal saline at the same time points. The shoulder pressure pain thresholds will be measured~     with a pressure algometer by an independent doctor blinding to medication and grouping at the~     day before surgery, 24h and 48h after surgery. Moreover, the intensity of shoulder pain and~     side effects will be evaluated by another independent doctor at 24h and 48h after surgery. At~     the end of the observation, the intensity of the maximal shoulder pain will be assessed.~   "
131738|NCT01842997|"~     Since October 2009, H1N1 influenza vaccine has developed and approved of immunization in~     population in China. However, there was little epidemiological evidence of safety when~     vaccinated in healthy pregnant women. The main objective of this study is to assess the~     safety of split-virion inactivated H1N1 vaccine without adjuvant when administered in healthy~     pregnant women. It is a stratified and controlled clinical trial in healthy pregnant women.~     And participants were included up to 226 healthy pregnant women aged 18 -35 years old who~     have no history of novel influenza H1N1 infection or novel influenza H1N1 vaccination. The~     pregnancy week ranged from 5 weeks to 32 weeks. Subjects were divided into 2 groups:~     vaccinated group（122） and unvaccinated group（104）. Subjects in the vaccinated group were~     administered one dose of 15μg H1N1 vaccine. Subjects in the unvaccinated group received no~     vaccine as controls. Safety will be measured by assessment of pregnancy outcomes. And~     observation time for pregnancy outcomes was lasting for 28 days postpartum since vaccinated;~     and protective effect was observed for six months.~   "
131739|NCT01842984|"~     The purposes of this study are: (1) decrease loneliness and social isolation and increase~     social competence and social integration of older adults experiencing loneliness; (2) examine~     an intervention process grounded in a theoretical model that was developed in a previous~     study. The intervention process is tailored to the participants' barriers and abilities, and~     includes up to 10 personal meetings with an activities counselor and several group meetings.~   "
131740|NCT01842971|"~     The aim of this study is evaluate the feasibility of early two-stage hepatectomy in patients~     with liver metastasis from colorectal cancer.~   "
131741|NCT01842958|"~     The primary objective of this study is to demonstrate non-inferiority of the Straumann Bone~     Level Ø 3.3 mm NC SLActive Roxolid Implants compared to Straumann Bone Level Ø 4.1 mm RC~     SLActive Roxolid Implants based on mean crestal bone level changes measured between surgery~     and 12 months post-implant placement. The secondary objectives will assess differences in~     clinical outcomes between the test and control implants, including implant success and~     survival, gingival recession, subject satisfaction and additional early bone level~     measurements.~   "
131742|NCT01842945|"~     The aim of this study is to examine the effects of cognitive behavior therapy (CBT) for~     procrastination, and to investigate whether it can be delivered via the Internet. Two~     treatment groups will be used, one with therapist contact and one without, as well as a~     wait-list control group. It is assumed that the treatment group with therapist contact will~     be superior to the treatment group receiving no therapist contact since procrastination can~     be partially explained as a self-regulatory failure. Both treatment groups are presumed to be~     superior to the wait-list control.~   "
131743|NCT01842932|"~     Usefulness of Flospan as a premedication for colonoscopy: A randomized double-blind~     controlled trial~   "
131783|NCT01842412|"~     The hypothesis of this study is that one bout of leg exercise gives acute qualitative changes~     in mitochondrial function in claudication. Final purpose is to determine the optimal exercise~     frequency in treatment of claudication.~   "
131812|NCT01842022|"~     A lower rather than a higher glycemic load (GL) meal has been shown to benefit cognition and~     mood, however, the data in older adults and those most prone to cognitive dysfunction, is~     limited and conflicting. One explanation is that the GL of a meal may interact with a~     person's pre-existing glucose tolerance (GT).~      As older adults have a higher incidence of glucose tolerance and are more likely to~     experience memory problems the present study considers the interaction between the GL of meal~     in those with better or poorer GT.~      The population studied will not have a history of diabetes or dementia. A battery of~     cognitive tests will be administered after meals sweetened with one of three sugars known to~     vary in the rate that they release glucose into the blood stream.~   "
131744|NCT01842919|"~     In this project investigators will evaluate the benefits of contemporary dance training using~     a comprehensive test battery combining standard neuropsychological batteries, psychological~     questionnaires on emotion, empathy and quality of life, structural magnet-resonance~     tomography (MRI), as well as psychophysical tests on movement recognition and agency, the~     sense of being in control of one's own movement.~      For 10 years now two experienced dancer‐choreographers lead dance workshops for people with~     Huntington's Disease (HD) and their family and caregivers in Paris. This project will~     evaluate objectively the effects these workshops have, by assessing a new group of 18~     patients and their partners and caregivers before and after 8 month of weekly dance training.~      People with HD are troubled by involuntary movements, of which they are however not~     accurately aware, but moreover they become impaired at recognising instrumental actions in~     others. It is well known that observing somebody else's action and executing the same action~     rest on a common neural network. This might mean that improving one's own action execution~     can improve the observation and understanding of others' actions in turn. Here, investigators~     will investigate both the impact the movement impairments caused by HD might have on patients~     themselves as well as on their partners and caregivers, as a consequence of the fact that own~     and other action representations are shared. After 8 months of contemporary dance training,~     both groups will be tested again, in order to establish if both action execution (self) and~     perception (in others) have improved.~      Other recent psychophysics and brain imaging experiments have demonstrated how the sense of~     agency is composed from external cues (for example sound) of the consequences of movements,~     and from internal sensorimotor information that result from the action plan. Importantly, in~     HD the latter input might be impaired, but this has never been systematically tested. Making~     use of a psychophysics paradigm disentangling the two cues to agency investigators first~     monitor the sense of their own movement in HD, and further assess the changes in agency and~     in the role of these cues to agency after eight months of contemporary dance practice.~      Finally investigators will monitor the structural brain changes accompanying this progress,~     comparing the brain before and after regular dance practice and correlating action~     recognition psychophysics measures of agency with these changes.~      In sum, this project has a double impact. Firstly it will scientifically evaluate the impact~     of dance on the normal but especially the brain affected by a neurodegenerative disease that~     causes movement impairments, and establish its effect on behaviour and wellbeing. Secondly it~     will evaluate in patient partners and caregivers how they represent the patients' as well as~     their own movements and how this changes with dance practice.~   "
131745|NCT01842906|"~     The study is examining if an over-the-counter device (Theravent) worn while sleeping can~     reduce acute mountain sickness upon awakening in a high altitude trekking population.~   "
131746|NCT01842893|"~     The purpose of the study is to assess the clinical effectiveness of Fentanyl ETHYPHARM when~     used to relieve breakthrough pain (BTP) in opioid-treated cancer patients.~   "
131747|NCT01842880|"~     The purpose of this study is to analyze the efficacy of MicroRNAs as biomarkers on the Chagas~     Disease prognosis. This analysis will be done through the correlation between the plasmatic~     levels of this molecule with functional and laboratory tests.~   "
131748|NCT01842867|"~     The purpose of this study is to analyze the efficacy of syndecan-4 as a biomarker on the~     Chagas Disease prognosis. This analysis will be done through the correlation between the~     plasmatic levels of this molecule with functional and laboratory tests.~   "
131749|NCT01842854|"~     The purpose of this study is to analyze the efficacy of Galectin-3 as a biomarker on the~     Chagas Disease prognosis. This analysis will be done through the correlation between the~     plasmatic levels of this molecule with functional and laboratory tests.~   "
131750|NCT01842841|"~     Gaucher disease is an inherited deficiency of the lysosomal enzyme glucocerebrosidase (GCB)~     that leads to progressive accumulation of glucocerebroside within macrophages and subsequent~     tissue and organ damage; typically of the liver, spleen, bone marrow, and brain. Type 1~     Gaucher disease affects an estimated 30,000 persons worldwide and is the most common. Type 1~     Gaucher disease does not involve the central nervous system. Patients with Type 2 Gaucher~     disease present with acute neurological deterioration, which leads to early death. Those with~     Type 3 disease typically display a more sub-acute neurological course, with later onset and~     slower progression.~      The primary objective of this study is to evaluate the long-term safety of every other week~     (EOW) dosing of velaglucerase alfa in Japanese patients with Gaucher disease who completed~     study HGT-GCB-087 and elected to continue treatment with velaglucerase alfa.~      Velaglucerase alfa has been developed and approved as an enzyme replacement therapy for Type~     1 Gaucher disease.~   "
131751|NCT01842828|"~     Currently available smoking cessation treatments help only about 15% of smokers to quit~     long-term. These treatments do not typically address the behaviours and sensations associated~     with the act of smoking (e.g. handling a cigarette, inhaling, taste and feel of smoke on the~     throat). There is evidence that these elements influence smoking behaviour and cessation.~     Electronic cigarettes (EC) are a new product with a strong potential to be a realistic~     behavioural replacement for smoking.~      Whilst EC deliver nicotine, their use does not involve tobacco combustion, which is the~     primary source of the many thousands of dangerous chemicals to which smokers of conventional~     cigarettes are exposed. Studies on EC products and users indicate there is little doubt that~     they are substantially safer than conventional cigarettes.~      The investigators plan to conduct a study one of the very first studies to test the effects~     of adding EC to standard care on long-term validated outcomes. Before launching such a large~     and demanding trial however, data are needed on what proportion of smokers would be~     interested in using EC and what compliance with EC use can be expected, and no data exist to~     inform how large a sample is needed. This pilot study would provide such data.~      A total of 220 smokers would be recruited at smoking cessation clinics in London (n=20),~     Madrid (n=100), and Prague (n=100). Within each site, half the smokers would be randomised to~     receive standard smoking cessation behavioural support and medication (standard care; SC),~     and half to receive SC plus EC. The EC group would receive a four week supply of EC. The~     outcome measures for the study would be smoking status at 4 and 24 weeks after the target~     quit date, EC use, acceptability, and adverse events.~   "
131752|NCT01842815|"~     The purpose of this study is to collect further data on the safety and efficacy of removing~     unwanted non cosmetic tattoos (including recalcitrant) using a 755nm Alexandrite laser.~   "
131753|NCT01842802|"~     The purpose of this study is to compare non invasive treatments using a YAG and Didode Laser~     to reduce the volume of fat.~   "
131754|NCT01842789|"~     The purpose of this study is to test both user preference and speed of targeting with the use~     of the Acessa System with Targeting Animation Guidance (TAG).~   "
131755|NCT01842776|"~     The goal of this pilot is to reduce the 30-day hospital readmission rate for dialysis~     patients. It is a quality improvement project that consistent of 4 tracks. Tracks 1 & 2:~     Implement use of checklists of activities for staff to complete when patients are admitted to~     the hospital, and post-hospitalization with emphasis on fluid assessment, nutrition~     management, patient coaching, and communication between institutions. Track 3: Work with~     physicians to develop process to individualize post-hospitalization dialysis orders and~     improve medication reconciliation. Track 4: Use a renal Care Transitions Case Manager to~     follow patients in the hospital and 30 days post-hospitalization to facilitate care and~     patient coaching.~   "
131756|NCT01842763|"~     The purpose of this non interventional research is to set up a French database, initially for~     3 years, of patients suffering from refractory chronic headache disorders (chronic migraine,~     cluster headache, chronic paroxysmal hemicranias, SUNCT syndrome, hemicrania continua,~     cervicogenic headache disorders), and treated by occipital nerves stimulation.~      Every team using this neuromodulation approach in France is likely to participate in the~     network.~      Fifty patients a year are expected. They will be informed about data which are collected and~     why they are collected.~      The data will come from medical files and questionnaires filling out by the patients. The~     data will be collected on a case report form adapted to each refractory chronic headache~     disorder. The case report form pages will be faxed to the coordinating team who will enter~     the data in the database and analyse the data in a descriptive manner.~      These data are social and demographic data, medical data (headache features, headache~     functional and emotional impact, medications, and concomitant medical conditions), technical~     data (kind of electrodes and implantable pulse generator used, stimulation parameters~     chosen), and safety data.~      This research should provide an update on practices, an evaluation of the efficacy and long~     term safety of occipital nerves stimulation, and perhaps help in identifying response~     predictive factors to this neuromodulation approach.~   "
131757|NCT01842750|"~     This study aims to test the hypothesis that insertion of an endorectal balloon into a patient~     receiving radical prostate radiotherapy by treatment radiographers is feasible without the~     patient experiencing undue discomfort. In addition this study will test the hypotheses that~     insertion of the rectal balloon prior to radiotherapy delivery stabilises rectal volume~     during radiotherapy treatment and minimises organ motion within the pelvis.~   "
131758|NCT01842737|"~     The Patient Response to Graded Sensory Stimulation-Pilot Study (PRoGReSS-PS) will measure~     back pain perceptions in participants who receive either chiropractic treatment or foot~     massage. The study will also measure back pain and function with research questionnaires and~     other measures.~   "
131759|NCT01842724|"~     The purpose of this study is to determine the difference in the results between Motec and~     Remotion wrist arthroplasty in the treatment of non-rheumatoid wrist arthritis.~   "
131760|NCT01842711|"~     A Cumulative Patch Test with a Challenge Phase is a test devised to ascertain if a chemical~     agent or agents have the potential to cause contact irritation or contact allergy in the~     skin. Allergy is only elicited in immunologically competent individuals who have become~     sensitized through exposure to the chemical agent at a sufficient concentration and for a~     sufficient duration of time.~   "
131761|NCT01842698|"~     Thoracotomy, is a surgical procedure performed routinely in connection with pulmonary~     surgery. Pain induced by thoracotomy is considered as the most severe post-operative pain.~     Control of the pain is essential in the perioperative management.~      Nowadays, there are several strategies to support this pain, including regional anesthesia~     techniques in the context of multimodal analgesia. Epidural analgesia reduces pain scores and~     respiratory complications significantly. ParaVertebral Block (PVB) is a technique as~     effective as epidural analgesia in the treatment of pain after thoracotomy and could present~     a more limited number of complications. However, there is no consensus on the best technique~     for realisation of PVB.~      Para-vertebral catheterisation can be performed by posterior approach in seeking a strength~     loss after bone contact of transverse vertebral process using the technique of Eason and~     Wyatt, but it is a blind technique. The ultrasonographic control, developed in the context of~     all puncture invasive actions, is an effective contribution to the realisation of a BPV, but~     still insufficiently validated. First used to measure the distance skin - posterior~     costo-transverse ligament and skin - parietal pleura before procedure, the ultrasonography~     has recently led to the publication of echo-guided techniques combining recognition of~     structures defining the space para- vertebral, viewing the progression of the needle and the~     spread of the local anesthetic. The handling of the ultrasonographic probe associated with~     the puncture requires additional learning.~      The objective of this project is to study the feasibility of para-vertebral catheter~     insertion under ultrasonographic control. The appearance like pigtail of the catheter, the~     most recently proposed, seems the more attractive in terms of safety. The aim of this pilot~     prospective study is accurately quantify all qualitative parameters related to the technique~     in order to achieve a future validation with a medico-economic component.~      Ultrasound-guided technique will correspond to a technique with a puncture of the lateral to~     medial space described by Shibata, after spotting of the first rib proposed by Bouzinac.~      This study will be proposed to patients undergoing thoracotomy for total or partial pulmonary~     resection in Thoracic Surgery service of Centre Jean Perrin, the number of patients required~     is 60 patients over a period of inclusion of 12 months.~   "
131762|NCT01842685|"~     In this study, the investigators will evaluate the efficacy of Bladder Thermal Distention~     (BTD) in patients with overactive bladder syndrome who failed previous treatment of~     anticholinergic drugs.~      The investigators' hypothesis is that it will improve the storage symptoms.~   "
131763|NCT01842672|"~     The combination of mitoxantrone and clofarabine as reinduction therapy will be safe, well~     tolerated and effective in children, adolescents and young adults with poor risk~     refractory/relapsed acute leukemia and high grade non-Hodgkin lymphoma (NHL).~   "
131764|NCT01842659|"~     Losses of imprinting are involved in various syndromes. Those occurring in the 11p15 region~     lead to Beckwith-Wiedemann and Silver-Russell Syndromes. These losses of imprinting follow a~     mosaic pattern, rendering their detection difficult, especially given the scarcity of~     available DNA in amniotic fluid. Thus, in spite of growing demand, prenatal diagnosis (PND)~     for imprinting abnormalities of the 11p15 region is not available.~      The recent development of a quantitative PCR method that permits the methylation index (MI)~     of imprinted regions to be calculated renders PND technically possible. Nevertheless, because~     of the mosaic nature of these anomalies, it is essential to verify that the methylation~     pattern of the 11p15 region obtained from the amniotic fluid matches that obtained from the~     blood.~   "
131765|NCT01842646|"~     This study is being done to see how safe an investigational drug is and test how well it will~     work to help people with refractory/relapsed myelodysplastic syndrome (MDS) or chronic~     myelomonocytic leukemia (CMML).~   "
131766|NCT01842633|"~     The purpose of this multi-center study is to assess the efficacy of headache relief of new~     paracetamol/caffeine formulation compared to placebo and ibuprofen in episodic tension-type~     headache (ETTH).~   "
131767|NCT01842620|"~     This is an open-label, single-center, randomized, 2-way crossover study to evaluate the~     bioequivalence of OXEMET™ 1000 mg coated tablets, relative to 1000 mg of the reference~     product administered as two 500 mg tablets, under fasting conditions, in 24 healthy adult~     subjects. Each subject will receive two treatments (Treatment A and Treatment B). In Period~     1, subjects will be dosed with either one OXEMET™ 1000 mg tablet (Treatment A, Test) or two~     500 mg tablets of reference product (GLAFORNIL™ 500 mg) (Treatment B, Reference). Following a~     washout of at least 7 days, subjects will be crossed over in Period 2 to receive the~     treatment that they did not receive in Period 1.~   "
131771|NCT01842568|"~     Worldwide over 2 million adults (>30,000 Canadians) undergo heart surgery annually. Although~     heart surgery provides important survival benefits, it is associated with potential major~     complications such as death, stroke, and heart attack. There is promising evidence that~     measurement of heart injury markers after surgery will identify patients at risk of death or~     major complications.~      This study will determine the current incidence of major complications in a representative~     sample of 15,000 contemporary adult patients undergoing heart surgery. Knowing the current~     burden of complications will inform clinicians, administrators, government and granting~     agencies about resources required to address the problem. This study will also establish the~     role of measuring heart injury markers to identify important heart injury after heart surgery~     and the proportion that would go undetected without routine heart injury marker monitoring.~     This information will facilitate further studies of timely interventions. In summary, the~     VISION Cardiac Surgery Study addresses fundamental questions that will have profound public~     health implications given the millions of adults worldwide who undergo heart surgery~     annually.~   "
131772|NCT01842555|"~     The data elements for the PDT Registry project include virtually all the elements in the~     standard hospital-based cancer registry record, although in some cases at a finer level of~     detail. All data points should be found in the participant's medical record. The principal~     difference between the PDT Registry data set and that collected by the registries is the~     inclusion of more information specific to PDT.~   "
131773|NCT01842542|"~     The purpose of this study is to evaluate the safety and effectiveness of acute NeuroStar TMS~     therapy in women who have postpartum depression.~   "
131774|NCT01842529|"~     The aim of this prospective randomized double-blind study was to compare the efficacy and~     safety of Botulinum toxin injection in epicardial fat pads for preventing recurrences (in~     early postoperative period) of atrial tachyarrhythmia in patients with paroxysmal atrial~     fibrillation undergoing coronary artery bypass graft (CABG) surgery.~   "
131775|NCT01842516|"~     Primary~        -  To investigate the safety and tolerability of LCB01-0371 after a multiple oral dose~        -  To investigate the pharmacokinetic characteristics of LCB01-0371 after a multiple oral~          dose in healthy male subjects~        -  To investigate the safety of LCB01-0371 after a multiple oral dose in healthy male~          subjects~   "
131776|NCT01842503|"~     Examination of the effect of GET 73 on alcohol pharmacokinetics and pharmacodynamics~     (intoxication and sedation)and safety profile in alcohol-dependent individuals.To evaluate~     whether GET 73, as compared to placebo, results in diminished cue-reactivity responses to~     alcohol cues in terms of urge to drink during the cue reactivity session and results in lower~     quantity of alcohol consumed during an alcohol self-administration session.~   "
131777|NCT01842490|"~     No serum biomarker has qualified for clinical use until now. However several biomarkers,~     especially markers of inflammatory or proteolytic activity seem to promising in the~     identification of vulnerable plaques. Moreover, recent study confirmed that contrast-enhanced~     ultrasound imaging(CEUS) can visualize intraplaque neovascularization and represent the~     plaque vulnerability. In this study we try to identify indicators through analysis of the~     relationship between plaque neovascularization seen by CEUS and well known biomarkers such as~     serum matrix metalloproteinase(MMP)-2, MMP-9, cathepsin family(L,S,V), cystatin C,~     lipoprotein phospholipase A2, and hs-crp~   "
131778|NCT01842477|"~     Bone grafting is widely used in hospitals to repair injured, aged or diseased skeletal~     tissue. In Europe, about one million patients encounter a surgical bone reconstruction~     annually and the numbers are increasing due to our ageing population. Bone grafting intends~     to facilitate bone healing through osteogenesis (i.e. bone generation) at the site of damage,~     but this is only attained presently by including cells capable of forming bone into the~     augmentation.~      Bone autograft is the safest and most effective grafting procedure, since it contains~     patient's own bone growing cells (to enhance osteogenesis) and proteins (to enhance~     osteoinduction), and it providing a scaffold for the new bone to grow into (osteoconduction).~     However, bone autograft is limited in quantity (about 20 cc) and its harvesting (e.g. from~     the iliac crest) represents an additional surgical intervention, with frequent consequent~     pain and complications.~      We hypothesize that using autologous bone marrow cells expanded in GMP facility surgically~     implanted with synthetic bone substitutes contribute to the resolution of the health and~     socioeconomic complications of delayed union or non-union after diaphyseal and~     metaphyseal-diaphyseal fractures with safety and efficacy.~   "
131779|NCT01842464|"~     Anterior-apical compartment mesh implants for pelvic floor reconstruction are anchored here~     to the Sacro-Spinous ligaments and evaluated being a feasible and effective method.~   "
131780|NCT01842451|"~     A Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of~     VX-135 and Daclatasvir in Treatment-Naïve Adult Subjects With Genotype 1 Chronic Hepatitis C~   "
131781|NCT01842438|"~     Even with careful prostate surgery, men find it difficult to have an erection. Our previous~     research shows that couples are not often supported to cope with the effects of surgery on~     their sexual relationships. In this study, the investigators will design a way of supporting~     couples, and test how well it works.~      The investigators will decide what the support should include (e.g. duration, frequency and~     timing of the support). The investigators will do this by looking at available literature on~     the subject.~      The investigators will recruit 68 couples to the study, half will receive standard care and~     the other half will be invited to attend six sessions of psychosexual support with specially~     trained professionals (trained by men affected by prostate conditions and a cancer/couple~     support specialist). Before and after the support, men and their partners will be asked to~     complete questionnaires which measure quality-of-life, emotional needs, and their~     relationship. The investigators will ask the couples to fill out the questionnaires again~     six-months later to see if the support has long-term benefits. At the end of the study the~     investigators will also interview 10 couples to find out their views of the support, and~     another 10 couples about standard treatment.~      When the investigators have tested this support, they expect to see men and their partners~     tell us that their quality of life has improved, and they have higher satisfaction with their~     relationship. The investigators will calculate the overall cost of providing this support,~     and the benefits it has on reducing the need for other health-care services (like General~     Practice use).~   "
131782|NCT01842425|"~     The purpose of this study is to determine what changes occur in body- and liver-composition~     during four weeks of low calorie diet in morbidly obese females~   "
131784|NCT01842399|"~     Background:~      - Resveratrol is a compound found in the skin of red grapes. It is being tested to see if it~     can have positive effects on human health. Lab studies show that it may help lower blood~     sugar, improve heart and blood vessel health, and prevent cancer. Researchers want to test~     different dose levels of Resveratrol to see what kind of effects it has on older overweight~     people. It will be tested in healthy volunteers at least 50 years of age.~      Objectives:~      - To test the effects of different dose levels of Resveratrol on heart and blood vessel~     health.~      Eligibility:~      - Healthy overweight nonsmoking volunteers at least 50 years of age.~      Design:~        -  This study will involve a screening visit and four study visits. Some of the study~          visits will involve overnight inpatient stays.~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. They will be given a list of foods that they should avoid~          eating while on the study.~        -  Participants will be separated into three groups. Two groups will take different dose~          levels of the study drug. The third group will take a placebo.~        -  At the first study visit, participants will stay in the clinical center overnight for 2~          days of tests. They will provide blood and urine samples and have body scans to measure~          fat and muscle mass. They will also have exercise tests. A muscle biopsy will also be~          performed. At this visit, they will receive their dose of the study drug. They will~          continue to take this dose for as long as they are on the study.~        -  The second visit will be 16 weeks after the first one. It will take only 2 hours, and~          repeat most of the tests from the screening visit.~        -  The third visit will be 16 weeks later. It will involve an overnight stay. Most of the~          tests from the second visit will be repeated.~        -  The fourth and final visit will be 16 weeks later. It will involve an overnight stay.~          Most of the tests from the initial study visit (including the scans and the exercise~          tests) will be repeated.~   "
131785|NCT01842386|"~     Background:~        -  Healthy people have white blood cells that protect them against bacteria, viruses, and~          fungi. However, some people have diseases which cause the body to make white blood cells~          that do not work properly. These white blood cells can attack the body s own proteins.~          These types of diseases are called anti-cytokine autoantibody-associated diseases. They~          can cause severe illnesses and even death. They are also difficult to treat with~          standard drugs.~        -  Rituximab is a drug used to treat rheumatoid arthritis. It attacks white blood cells~          that do not work properly. Currently, it is not approved for treating anti-cytokine~          autoantibody-associated diseases. However, researchers think that it may be able to help~          treat people with these immune diseases.~      Objectives:~      - To see if rituximab is a safe and effective treatment for anti-cytokine~     autoantibody-associated diseases.~      Eligibility:~        -  Individuals at least 18 years of age who have anti-cytokine autoantibody-associated~          diseases.~        -  Participants must also be enrolled in a related immune disorder study at the National~          Institutes of Health.~      Design:~        -  The study will last 24 months. Participants will take rituximab for 6 months and have~          follow-up visits for the remaining 18 months.~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Other samples will be collected as needed if participants~          currently have an infection.~        -  Participants will enter the hospital for 1 week at the start of treatment. They will~          have four doses of rituximab given 2 days apart. This first treatment will be monitored~          with frequent blood tests.~        -  Over the next 6 months, participants will have four more doses of rituximab given about~          1 month apart. Treatment will be monitored with frequent blood tests and sample~          collections as needed.~        -  There will be four follow-up study visits at 3, 6, 12, and 18 months after the last dose~          of rituximab.~   "
131786|NCT01842373|"~     The purpose of this research study is to test which topical anesthesia: LMX4 (Lidocaine 4%)~     or BLT (Benzocaine 20%, Lidocaine 6%, and Tetracaine 4%) is more effective in reducing~     discomfort during treatment with the Fraxel DUAL 1550/1927 (Solta Medical, Hayward, CA). No~     studies have been done on the effectiveness of LMX4 versus BLT using the Fraxel DUAL,~     although individually LMX4, BLT, and the Fraxel DUAL have been studied extensively.~      The hypothesis is that there will be no clinical difference between the two topical~     anesthetics.~   "
131787|NCT01842360|"~     The purpose of the study is to evaluate the efficacy and safety of a biological vaccine~     (MV130 in subjects with Chronic Obstructive Pulmonary Disease (COPD) compared with a placebo~     group.~   "
131788|NCT01842347|"~     The purpose of this study is to treat children with severe, moderate, resistant or relapsing~     C. difficile infection and to determine the changes in the intestinal microbiome (all of the~     bacteria living in the intestines) in children receiving FMT for C. difficile infection. Data~     will be collected throughout the FMT procedure to determine effectiveness and to help~     standardize this procedure. Stool samples will be collected to look at the different bacteria~     that are in the intestines before and after FMT.~   "
131789|NCT01842334|"~     1. Compare the relative efficacy of ten weeks of once weekly 250 mg D-cycloserine (DCS) vs.~          placebo (both in conjunction with cognitive behavioral therapy (CBT) and nicotine~          replacement therapy (NRT) on reducing cigarette smoking in treatment-seeking~          nicotine-dependent outpatients.~        2. Compare the relative efficacy of ten weeks of once weekly 250 mg DCS vs. placebo on the~          process of extinction and the memory encoding process.~   "
131790|NCT01842321|"~     The purpose of this study is to estimate antitumour activity of abiraterone acetate in~     Patients with a Molecular Apocrine HER2-negative locally advanced or metastatic Breast~     Cancer.~   "
131791|NCT01842308|"~     This phase I/II trial studies the side effects and best dose of carfilzomib when given~     together with melphalan and to see how well they work in treating patients with multiple~     myeloma before stem cell transplant. Carfilzomib may stop the growth of cancer cells by~     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as~     melphalan, work in different ways to stop the growth of cancer cells, either by killing the~     cells or by stopping them from dividing. Giving carfilzomib together with melphalan may kill~     more cancer cells.~   "
131792|NCT01842295|"~     The purpose of this study is to evaluate the impact of a bariatric surgery (gastric banding,~     bypass, sleeve gastrectomy) on several parameters (quality of sperm and others biological~     parameters, lifestyle, quality of life) involved in fertility of obese adult men.~   "
131793|NCT01842282|"~     This study involves the use of a research drug, Amlexanox, for the treatment of type 2~     diabetes, insulin resistance, obesity and non-alcoholic fatty liver disease (NAFLD).~     Amlexanox is taken orally in a pill three times a day. The investigators plan to continue~     therapy for a period of 12 weeks followed by a follow-up 4 weeks after therapy ends. The~     investigators will evaluate the changes in metabolic parameters (e.g. blood cholesterol,~     liver function, insulin resistance) and body composition characteristics (e.g. the pattern of~     fat distribution in the body). Seven eligible subjects in this study will also be evaluated~     for a change in liver disease by a liver biopsy.~   "
131794|NCT01842269|"~     Efficacy and Safety of My-Rept® Tablet(Mycophenolate Mofetil 500mg/Tab.) versus My-Rept®~     Capsule(Mycophenolate Mofetil 250mg/Cap.) in Combination with Tacrolimus in Kidney Transplant~     Patients~   "
131795|NCT01842256|"~     The purpose of this study is to investigate the effect of telmisartan/s-amlodipine on the~     pharmacokinetic properties of atorvastatin.~   "
131809|NCT01842061|"~     The investigators propose a 6-month, parallel, single-blind randomized controlled trial (RCT)~     feasibility study of a self-management program to reduce sedentary time and increase physical~     activity (Sit Less to Move More) in women aged 55-70 years. The primary aim is to determine~     feasibility and acceptability of the intervention; and the secondary aim is to test the~     effect of the intervention on the primary health outcome, physical activity (mean daily step~     count by accelerometry) at 6 months. The investigators will also conduct an economic~     evaluation and a process evaluation to guide a future larger study and to inform a scaled-up~     implementation plan.~   "
131796|NCT01842243|"~     Despite considerable effort the optimal site to place a pacemaker lead at the time of~     pacemaker implant remains unclear. Historically pacemaker leads have always been inserted at~     the bottom (apex) of the heart. It is suggested that a lead placed at the apex is associated~     with an increase in heart rhythm problems and also heart failure (impaired pumping function).~     The top of the ventricle (septum) has been investigated as an alternative site and is now~     routinely used by some centres. Previous estimation of the hearts pumping function (ejection~     fraction) has been limited to the use of echo (sound waves). Echo is not sensitive enough to~     detect small changes in the ejection fraction reliably (measure of pumping function of~     heart). The gold standard for measurement of ejection fraction is MRI (using magnets).~     Previous pacemakers have not been compatible with MRI scans. The latest generation of~     pacemakers are now able to be safely scanned within an MRI scanner. This allows a much more~     accurate estimation of the effects of a pacemaker on the ejection fraction which has not yet~     been studied.~      The investigators plan to study those patients undergoing a pacemaker implant and ablation~     procedure as part of their standard care.~      Individuals will have an exercise test, blood test used to measure biomarkers and fill in a~     symptom questionnaire.~      Individuals will have a Cardiac MR compatible pacemaker fitted and 2 ventricular leads will~     be inserted, one apically and one septally. Only one lead will be used at any given time.~     Individuals will then undergo their planned AV node ablation.~      Following this they will have a cardiac MR scan. Further MRI scans will be performed at 9 and~     18 month intervals, as will symptom questionnaires, blood tests (BNP) to determine heart~     muscle strain, exercise testing and echocardiograms.~      The hypothesis is that a lead placed on the septum will produce superior cardiac performance~     over the short and long term.~   "
131797|NCT01842230|"~     The purpose of this study is to investigate the effect of Atorvastatin on the pharmacokinetic~     properties of Telmisartan/S-amlodipine~   "
131798|NCT01842217|"~     Validation of [18F]-FES for imaging of estrogen receptors in the brain~      The primary objective of the study is to determine if [18F]-FES Positron Emission Tomography~     (PET) can be used to quantify the estrogen receptor expression in the human brain.~   "
131799|NCT01842204|"~     A monocentric interventional randomized placebo controlled trial evaluating the efficacy of~     the post surgical and wound care recovery kit.~      It's a small device that consists of a thin metal ring that is placed on the skin surface,~     non-invasively. It's connected with a small battery. When the plastic tag is removed and the~     button is pushed the device is activated. Within the ring a Pulsed Electromagnetic Field is~     created. It influences the receptor-ligand binding at the cell surface and might improve~     wound healing by diminishing wound edema and inflammation. It possibly helps reducing the~     inflammatory reaction induced by surgery.~      Patients will be treated for uni or bilateral inguinal hernias and at the end of surgery, at~     the time of bandage, a kit will be applied at the level of the incision. One group will at~     random receive a working device, the other half will have a kit without active~     electromagnetic field.~      Postoperative analgesic consumption will be measured in a diary and pain and quality of life~     will be measured using Visual Analogue Scale and EuraHS-Quality Of Life questionnaires.~      The aim of this study is to evaluate whether the placement of the device reduces the acute~     postoperative pain and whether it reduces the incidence of chronic groin pain.~   "
131800|NCT01842191|"~     The aim of the present work was to evaluate the efficacy of fish oil supplementation on serum~     proinflammatory cytokines levels, oxidative stress markers and disease progression in MS.~   "
131801|NCT01842178|"~     This study is designed to evaluate the potential benefit in pregnancy rates produced by an~     endometrial scratching made in an IVF cycle prior to embryo transfer in patients with donated~     oocytes.~   "
131802|NCT01842165|"~     The purpose of this study is to determine if 68Gallium-octreotate and 18Fluorodesoxyglucose~     uptake, apparent diffusion coefficient and post 177Lu-octreotate SPECT/CT dosimetry are~     reliable predictors for lesion-by-lesion treatment outcome.~   "
131803|NCT01842139|"~     This randomized phase I trial studies the side effects and best way to give vaccine therapy~     together with basiliximab in treating patients with acute myeloid leukemia (AML) in complete~     remission. Vaccines made from the WT1 peptide may help the body build an effective immune~     response to kill cancer cells. Montanide ISA 51 VG and poly-ICLC may enhance this response.~     Monoclonal antibodies, such as basiliximab, can block cancer growth in different ways. Some~     block the ability of cancer to grow and spread. Others find cancer cells and help kill them~     or carry cancer-killing substances to them. It is not yet known whether WT1 126-134 peptide~     vaccine with Montanide ISA 51 VG is more effective than with poly-ICLC when given together~     with basiliximab in treating AML~   "
131804|NCT01842126|"~     The primary objective of the study is to evaluate the safety and tolerability of a range of~     single intravenous (IV) and subcutaneous (SC) doses of BG00010 in healthy volunteers, and a~     range of multiple SC doses of BG00010 in participants with painful lumbar radiculopathy.~     Secondary objectives of this study are to determine the single IV and SC dose~     pharmacokinetics (PK) profile of BG00010 in healthy volunteers including assessment of~     bioavailability by comparing SC exposure to IV exposure in each participant, to determine the~     multiple SC dose PK profiles of BG00010 in participants with painful lumbar radiculopathy, to~     assess the single IV and SC dose immunogenicity of BG00010 in healthy volunteers, to assess~     the multiple SC dose immunogenicity of BG00010 in participants with painful lumbar~     radiculopathy, and to assess the potential of BG00010 to reduce pain following multiple SC~     administrations in participants with painful lumbar radiculopathy.~   "
131805|NCT01842113|"~     The purpose of this study is to determine whether taking Rifaximin (Xifaxan) in conjunction~     with the use of nutritional concepts is effective in improving morbidity and quality of life~     in cirrhotic patients suffering from hepatic encephalopathy (HE).~   "
131806|NCT01842100|"~     Screen-and-treat approach reduces postabortal pelvic inflammatory disease after induced~     abortion, and at the same time alters women's sexual behavior and prevents further~     re-infection by sexually transmitted infections when compared to the universal antibiotic~     prophylaxis strategy.~   "
131807|NCT01842087|"~     A single blind, six week dietary intervention will be conducted in order to evaluate the~     impact of fiber fortified foods on blood urea nitrogen, kidney function and quality of life~     in patients presenting with a moderate to severe decline in kidney function.~   "
131808|NCT01842074|"~     The investigators plan to study the role of bortezomib for desensitizing patients awaiting a~     living kidney donation who have a titer of Donor Specific anti human leucocyte antigen (HLA)~     Antibody (DSA) between 1000 and 3000 MFI with a pilot study of 10 patients recruited in 4~     hospital in FRANCE.~   "
131810|NCT01842048|"~     The main goals of deep hyperthermia combined with external beam radiation (EBRT) on bone~     metastases are the response on pain relief, duration of response and time to achieve complete~     pain relief.~   "
131811|NCT01842035|"~     The purpose of this study is to determine whether a blunted heart rate response to~     regadenoson is an independent predictor of sudden cardiac death.~   "
131815|NCT01841983|"~     While most of the research on integrated approaches of occupational health and safety and~     worksite health promotion to date has focused on manufacturing settings, employment is~     shifting to the service sector. Within this sector, health care employs over 12 million~     workers, and is the second fastest growing industry in the U.S. economy. In contrast to~     workers in other industries, rates of occupational injuries and illnesses among health care~     workers have increased over the past decade. The purpose of this study is to lay the~     foundation for integrated interventions in health care through examination of the~     associations of worker health outcomes and risks on and off the job with work policies and~     practices and to address the prevalent issues of musculoskeletal disorders (MSDs),~     particularly low back pain disability (LBPD), and health promotions through physical activity~     among patient care workers. The specific aims of this study are:~        1. To estimate the efficacy and determine the feasibility of an integrated intervention,~          addressing both health protection and health promotion in order to reduce MSD symptoms~          and improve health behaviors among healthcare workers. We will assess between-group~          differences in MSD symptoms, health behaviors, including physical activity, and a set of~          secondary outcomes, including unplanned absence, reported injuries, worker compensation~          claims and costs, turnover and retention, intention to leave the job, and work-role~          function. This study will explore the working hypothesis that: Workers employed at~          baseline in patient-care units receiving the intervention will report greater reductions~          in their MSD symptoms (primary outcome) and greater improvements in health behaviors,~          compared with workers employed at baseline in units assigned to the Usual Care control~          group.~        2. To determine the factors in the work environment which contribute over time to~          reductions in MSD symptoms and improvements in safe and healthy behaviors. (1) The work~          environment, work organization, and psychosocial factors, measured in our current study,~          will be associated with changes in workers' health behaviors and health outcomes between~          the assessments in the current and proposed studies; (2) Improvements in the work~          environment over time will be associated with improvements in workers' health behaviors~          and health outcomes. We will conduct multilevel modeling analysis to evaluate the~          simultaneous effects of worker-level and unit-level factors on MSD symptoms and safety~          and health behaviors.~   "
131816|NCT01841970|"~     Hemorrhoids are vascular cushions in the anal canal. People are normally born with~     hemorrhoids, and the presence of hemorrhoids does not imply disease. However, hemorrhoids~     typically cause symptoms when they enlarge over time. There are two types of hemorrhoids-~     External Hemorrhoids and Internal Hemorrhoids.~      Current minimally invasive technologies for the treatment of internal hemorrhoids are~     associated with several drawbacks that include high rate of recurrence and a need for~     repetitive procedures, frequent post-procedural pain or significant discomfort,~     intra-operative pain and technically demanding. The purpose of this study is to determine~     whether the HET Bipolar System is safe and effective in the treatment of Stage I and Stage II~     hemorrhoids (internal hemorrhoids). The HET Bipolar System is a new alternative device for~     the minimally invasive treatment of Stage I and Stage II hemorrhoids that incorporate design~     features with the intent of resolving each of the major limitations of currently available~     technology.~   "
131817|NCT01841957|"~     To evaluate the safety and efficacy of treating visually significant bilateral cataract with~     the newer technique of Immediate Simultaneous Bilateral Cataract Surgery (ISBCS) versus the~     conventional technique of Delayed Sequential Bilateral Cataract Surgery (DSBCS) in a select~     patient population.~   "
131818|NCT01841944|"~     The aim of the present study is to investigate the possible effects of supplementation with~     1.8 g/day of n-3 polyunsaturated fatty acids on cardiovascular morbidity and mortality during~     a follow-up period of 2 years in an elderly population after having experienced an acute~     myocardial infarction.~      The hypothesis is that this supplementation on top of modern therapy will reduce the combined~     cardiovascular end-point of death, non-fatal myocardial infarction, stroke and~     revascularizations with at least 30%.~   "
131819|NCT01841931|"~     The purpose of this study is to examine whether buprenorphine can be at least as effective as~     other opioid medications in relieving chronic pain in patients who suffer from dependence on~     their opioid medications, while patients simultaneously experience progressive decline of~     pain along with absence of opioid withdrawal symptoms and improved quality of life.~   "
131820|NCT01841918|"~     The purpose of this study is to evaluate immune response and safety of live attenuated~     influenza H5 vaccine candidate strain A/17/turkey/Turkey/05/133 (H5N2) manufactured by GPO,~     Thailand in healthy Thais.~   "
131821|NCT01841905|"~     The investigators are conducting a study to try to improve our ability to identify older~     adults who are at high-risk for progression to Alzheimer's disease, several years before they~     have symptoms that might reduce their quality of life. The investigators believe they can~     increase the sensitivity of tests of memory and problem solving, by using a very small dose~     of a medication (scopolamine) that reduces the activity of the principal chemical system in~     the brain that is changing in the earliest stages of Alzheimer's disease. By pairing this~     micro-dose drug challenge (that is administered with a tiny needle placed just under the~     surface of the skin on the forearm), with our tests of memory and thinking, it is believed~     that the investigators can create a stress test that is very similar in concept to the use~     of the exercise treadmill to make the results of a heart EKG more sensitive to detect early~     disease, as a cardiac stress test for heart disease. The investigators want to create a~     similar stress test for Alzheimer's disease (AD).~   "
131822|NCT01841892|"~     Methadone is effective for heroin addiction, but many methadone patients continue to use~     cocaine. High magnitude and long-duration voucher-based abstinence reinforcement, in which~     participants receive vouchers exchangeable for goods and services contingent on providing~     drug-free biological samples, is one of the most effective treatments for drug addiction and~     can maintain cocaine abstinence over extended periods of time. Our research on a model~     Therapeutic Workplace has shown that employment-based abstinence reinforcement, in which~     participants must provide drug-free urine samples to access the workplace and maintain~     maximum pay, can maintain cocaine abstinence and reduce drug-related HIV risk behaviors over~     extended time periods. Our next challenge is to disseminate employment-based reinforcement~     for the treatment of drug addiction. The investigators propose to develop, manualize, and~     pilot test a community-friendly Therapeutic Workplace intervention that can be implemented~     widely throughout the US and elsewhere. Methadone patients who use injection or crack cocaine~     during methadone treatment will be invited to participate (N = 58) and randomly assigned to~     one of two groups: Usual Care (control) group or Community Therapeutic Workplace group. As in~     our prior implementations of the Therapeutic Workplace intervention, Community Therapeutic~     Workplace participants will enroll in Phase 1 to initiate drug abstinence and acquire job~     skills. Participants who initiate abstinence and acquire job skills in Phase 1 will be hired~     into community workplaces with collaborating employers in Phase 2. During Phase 2,~     employment-based abstinence reinforcement contingencies will be implemented using procedures~     for workplace drug and alcohol testing overseen by the US Department of Transportation. Using~     this system, a national provider of Drug-Free Workplace Services will arrange random drug~     testing and employment-based abstinence reinforcement contingencies in which employees will~     be required to remain drug-free to maintain employment. The investigators hypothesize that~     participants in the Community Therapeutic Workplace group will provide more drug-free~     samples, and engage in fewer HIV-risk behaviors than participants in the Usual Care group.~     The study will provide vital information on the acceptability of the intervention to~     participants and employers, and provide preliminary data on the effectiveness of the~     investigators procedures to maintain abstinence and promote employment.~   "
131823|NCT01841879|"~     The investigators are designing and testing the effectiveness of an integrated tobacco~     control and occupational health (OH) intervention aimed at promoting tobacco cessation among~     workers and supporting the adoption, implementation, and enforcement of tobacco control~     policies in 20 manufacturing worksites in the greater Mumbai region of India.~   "
131939|NCT01840371|"~     The investigators study is the randomized controlled study for analyzing clinical benefit of~     pain focused sedation with combination of fentanyl and propofol during Endoscopic retrograde~     cholangiopancreatography (ERCP). The investigators will assess recovery time and adverse~     effect during ERCP as the primary end point between two group. The investigators will also~     access satisfaction score for endoscopist and patients as the secondary end point.~   "
131824|NCT01841866|"~     Laryngeal mask airway (LMA) is widely used in children.The appropriate time to remove~     laryngeal mask airway is still inconclusive.Sore throat is one of common complications after~     general anesthesia. Sometimes postoperative sore throat affects patients' satisfaction and~     daily activities. It can be correlated with dysphagia and may limit oral intake especially in~     children.The incidence of postoperative sore throat after laryngeal mask airway insertion~     varies from 5.8-34% in adult(13) and 17.5% in pediatric.Somehow, almost the studies of~     postoperative sore throat after laryngeal mask airway removal were done in awake state. Our~     study object to test that post operative sore throat after LMA removal in deep anesthetized~     children is lower than awake children.~   "
131825|NCT01841853|"~     The aim of this research project is to evaluate a health-promoting and disease-preventive~     intervention for older foreign-born adults. The overarching goal of the intervention is to~     preserve participant's health, quality of life, and minimize their need of medical care.~   "
131826|NCT01841840|"~     Stroke is the third leading cause of death in the United States. Of those who are affected by~     stroke, a third becomes permanently disabled. Risk factors for stroke include, but are not~     limited to, advancing age, physical inactivity, arterial stiffness, and most commonly, high~     blood pressure. Stroke is a major form of a much boarder problem, cardiovascular disease~     (CVD). CVD is considered the primary cause of death in the US. Interestingly, increased~     arterial stiffness of elastic arteries (carotid and aorta) has been shown to be strongly~     correlated to CVD and stroke. Increased arterial stiffness is considered an independent risk~     for the development of CVD and stroke. Hence, arterial stiffness has been suggested as a~     potential therapeutic target for CVD and more specifically stroke.~      Recently, whole-body vibration (WBV) exercise has been proposed as a new and effective method~     to improve muscle mass and muscle strength in younger and older individuals. It is known that~     systemic arterial stiffness decreased 40 min after a single WBV session in healthy men. In~     our laboratory, we have shown that leg arterial stiffness decreases after a session of WBV.~     Taken together, this data seems to suggest WBV may be used as a viable way to decrease~     arterial stiffness. Special populations, such as post-stroke patients, may be unwilling or~     unable to perform WBV exercise so an inactive form of exercise (vibration) therapy is needed.~      Passive vibration (PV), allows patients to lie in an inactive, supine position, with their~     legs placed onto the vibration plate. This exposes the lower limbs to continuous vibration~     without performing voluntary muscle contraction. PV has been shown to increase skin blood~     flow on the vibrated extremity through vasodilation in healthy individuals and type 2~     diabetics. Previous work in our laboratory has demonstrated that a 10-min session of PV on~     the legs decreases augmentation index (AIx) , a marker of pressure wave reflection, as well~     as leg and systemic PWV through decreases in local peripheral resistance in young men.~     However, the effects of PV on arterial function in post-stroke patients are unknown.~      It is hypothesized that post-stroke patients will demonstrate a decrease in leg PWV and~     central AIx. However, greater responses are expected with the lower vibration frequency.~   "
131827|NCT01841827|"~     We will use Cilostazol as a tool to investigate its headache inducing effects in migraine~     patients.~   "
131828|NCT01841814|"~     The purpose of this study is to assess changes of bone mineral density (BMD) at 12 months~     during the therapeutic management of patients with lymphoma.~   "
131829|NCT01841801|"~     To assess the safety and tolerability for the extended wear of an experimental air-activated~     self adhesive patch.~   "
131830|NCT01841788|"~     A disposable, air-activated, adhesive backed heat patch is being developed to provide~     temporary relief from minor muscular ache and joint pains associated with overexertion~     strains and sprains as well as minor pain associated with arthritis. The aim of the study is~     to determine the safety and tolerability of the patch during normal wear conditions.~   "
131831|NCT01841775|"~     Multicenter prospective follow-up of a not controlled chronic hepatitis C genotypes 2/3~     patients cohort with treatment indication with interferon α 2b and ribavirin for 24 weeks,~     and the verification of sustained virological response at week 48.~      The eligibility criteria and outcome measures followed the Clinical Protocol and Therapeutic~     Guidelines for Chronic Viral Hepatitis C, published by the Ministry of Health:~      http://portal.saude.gov.br/portal/arquivos/pdf/pcdt_hepatite_c_2011_retificado.pdf~   "
131832|NCT01841762|"~     SYMPHONY is prospective, multi-center, open-label, single-arm, Phase 3b psychometric~     validation study of the PAH-SYMPACT, a new quality of life questionnaire for patients with~     pulmonary arterial hypertension. Patients will be in the study for 5 1/2 months, 4 months of~     which they will receive macitentan, 10 mg, once daily.~      The primary objectives are to demonstrate the final content validity of the PAH SYMPACT~     instrument, to demonstrate the psychometric characteristics of reliability and construct~     validity of the PAH-SYMPACT instrument, and to demonstrate the ability of the PAH SYMPACT~     instrument to detect change. The secondary objective is to assess the safety of macitentan in~     patients with pulmonary arterial hypertension. The exploratory objective is to explore the~     effects of macitentan on PAH symptoms and their impact (as measured by the PAH-SYMPACT) in~     patients with pulmonary arterial hypertension.~   "
131833|NCT01841749|"~     The rate of axillary dissection avoided in patients with Ductal Carcinoma in Situ (DCIS) and~     a mastectomy indication will be obtained by calculating the proportion of women with GAS~     in-patient population that will prove to be DCIS or DCIS-MI + CCI. A confidence interval of~     95% will be deferred.~   "
131834|NCT01841736|"~     This randomized phase II trial studies how well pazopanib hydrochloride works in treating~     patients with carcinoid tumors that are growing, spreading, or getting worse. Pazopanib~     hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth.~   "
131835|NCT01841723|"~     This phase II trial studies how well ibrutinib works in treating patients with hairy cell~     leukemia that has returned after a period of improvement. Ibrutinib may stop the growth of~     cancer cells by blocking some of the enzymes needed for cell growth.~   "
131836|NCT01841710|"~     This proposal describes a pilot study aimed at determining whether genetic variations in~     taste receptors determine differential taste tolerability of pediatric medications.~   "
131837|NCT01841697|"~     This is a non-inferiority study comparing omarigliptin with sitagliptin in participants with~     type 2 diabetes mellitus (T2DM) with inadequate glycemic control on metformin therapy. The~     primary hypothesis is that after 24 weeks, the mean change from baseline in hemoglobin A1c~     (A1C) in participants treated with omarigliptin is non-inferior to that in participants~     treated with sitagliptin. There will be a 2-week run-in period with placebo + metformin prior~     to the double-blind treatment period.~   "
131838|NCT01841684|"~     This study will evaluate the safety and effect of anacetrapib on low-density~     lipoprotein-cholesterol (LDL-C) when added to ongoing lipid-lowering therapy. The primary~     hypothesis is that treatment with anacetrapib 100 mg for 12 weeks will lower LDL-C to a~     greater extent than treatment with placebo.~   "
131940|NCT01840358|"~     The purpose of this study is to determine if patients have more hypoglycemic episodes the~     first 3 days following pump start compared to their usual number of hypoglycemias with our~     actual pump initiation protocol.~   "
131839|NCT01841671|"~     The rationale for this study (IPV 002ABMG) is to evaluate and compare three doses of IPV, two~     doses of IPV plus one bOPV, and one dose of IPV plus two doses of bOPV in order to provide~     evidence for better immunization policy making in regions of the world that must switch to~     use of IPV/bOPV schedules in the 2014-2015 time frame. The goal is to identify the best~     option optimizing humoral immune responses, intestinal immunity and thereby prevent community~     transmission as well as preventing VAPP. Specifically, the study seeks to show that both of~     the sequential regimens are equivalent (not-inferior) to the 3-dose IPV regimen in the~     seroconversion rates to both type 1 and type 3 poliovirus such that not more than 10% of~     subjects fall below the 95% confidence interval observed for the 3-dose IPV alone regimen and~     the geometric mean titers (GMTs) are no more than 2/3 logs less than those for the 3-dose IPV~     regimen. In addition, the study will evaluate by a novel method (poliovirus shedding index),~     the adequacy of IPV vaccines in inducing intestinal immunity, specifically by reducing the~     shedding of poliovirus type 2 after an OPV challenge. The hypotheses of the study are:~        -  A 3-dose IPV/bOPV sequential schedule including 1 or 2 doses of bOPV is non-inferior in~          terms of types 1 and 3 seroconversion rates and GMTs to a 3-dose IPV schedule.~        -  Two and possibly 1 IPV dose(s) provides significant seroconversion rates and GMTs to~          type 2 poliovirus and sufficient priming to induce a rapid immune response in the~          context of an oral challenge at 7 months of age.~        -  Three, 2, and possibly 1 dose of IPV will induce intestinal immunity to poliovirus type~          2 as measured by a combination of quantity of virus in stools and duration of shedding~          (shedding index).~      In addition to these 3 hypotheses, the study will explore the following hypothesis:~      • Co-administration of bOPV and rotavirus at 16 weeks of age (the second rotavirus dose)~     provides similar antirotavirus IgA seroconversion rates and GMCs compared to subjects~     receiving rotavirus vaccine together with IPV.~   "
131840|NCT01841658|"~     The objective of this study is to identify genes whose expression is potentially modifiable~     due to changes in folate intake and help delineate mechanisms accounting for the variability~     in individual response to folic acid supplementation. The study will be conducted in normal~     weight and obese women of childbearing age, supplemented for 8 weeks with 800 mcg/day folic~     acid.~      It is hypothesized that (1) a change in folate status, induced by the supplementation, will~     influence the DNA methylation of specific genes and (2) the DNA methylation response to folic~     acid supplementation may differ between the normal weight and the obese women of childbearing~     age.~   "
131841|NCT01841645|"~     The purpose of the study is to investigate the effects of Conjugated Linoleic Acid (CLA) from~     dairy products on fatty acid metabolism and human health. A CLA depletion-repletion study was~     carried out with healthy volunteers. CLA depletion was achieved through an eight-week dairy~     fat restriction, followed by an eight-week repletion period consisting of intake of a butter~     naturally enriched with CLA. Changes in body composition, fasting glucose and insulin,~     inflammatory mediators, cell membranes' stability, plasma lipid levels and fatty acid~     composition of lipid classes are evaluated after depletion and repletion phases.~   "
131842|NCT01841632|"~     MultiStem ® is a new biological product, manufactured from human stem cells obtained from~     adult bone marrow. Factors expressed by MultiStem cells are believed to regulate immune~     system function and augment tissue repair.~      Standard of care pharmacological immunosuppression after liver transplantation can achieve~     reasonable survival of liver grafts and patients. The side effects of this treatment,~     however, are clinically significant and diminish the overall success of organ transplantation~     as a curative therapy. It is therefore the objective of this study to implement cellular~     immunomodulation therapy with MultiStem as an adjunct to standard pharmacological~     immunosuppression with the ultimate goal of significantly reducing drug-based~     immunosuppression.~      As this is the first study with MultiStem in this subject population it has been designed as~     a safety and feasibility trial. However, first evidence of a potential benefit for this~     patient population will be explored cautiously.~   "
131843|NCT01841619|"~     The purpose of this research study is to show that non-steroidal treatment with intravenous~     immunoglobulin (IVIg) can replace current systemic immunosuppressive therapy in cutaneous~     lupus erythematosis (CLE) patients.~   "
131844|NCT01841606|"~     Ondansetron is a medication routinely given to mothers having cesarean deliveries to help~     prevent and treat nausea and vomiting. The investigators are studying the hemodynamic effects~     of prophylactic ondansetron on parturients undergoing elective cesarean deliveries under~     spinal anesthesia.~   "
131845|NCT01841593|"~     The purpose of the study is to look at the levels of an HIV medication (raltegravir) in the~     blood, and how it is affected if raltegravir is taken at the same time as another medicine~     for high blood pressure (amlodipine). Many patients with HIV will also have high blood~     pressure, so it is important to know which drugs for each of these conditions can be taken~     together without affecting how well they work individually.~      Over a 3 week period, participants took amlodipine for 2 weeks, and raltegravir for 2 weeks,~     with the middle week being on both drugs. The investigators will look at and compare the~     levels of these two drugs in the blood after subjects have taken them separately and both~     together.~      This study is randomised into two groups with both study medications received by all~     participants in a three-period crossover pattern; randomisation determined which medication~     was taken first. Once randomised allocation was performed, medications were administered in~     an open-label fashion.~   "
131846|NCT01841580|"~     Approximately 70 million people world-wide are affected with glaucoma, of whom 6.7 million~     have bilateral blindness.5 Elevated intro-ocular pressure is the major modifiable risk factor~     in glaucoma, and reducing intraocular pressure to a consistently low level can delay disease~     progression and therefore, blindness.6 Topical intraocular pressure -lowering medication~     remains the first-line treatment for glaucoma, with surgical intervention playing a secondary~     role in cases suboptimally controlled with medication alone.~      In this study, we plan to assess the change in tear proteins in trabeculectomy patients~     before and after operations. It is hoped that this study could help us gain more~     understanding of the possible mechanism accounting for the development of dry eye disease in~     glaucoma patients, which could help us develop better screening modalities and therapeutic~     agents for glaucoma patients at risk to prevent the development of dry eye disease.~   "
131847|NCT01841567|"~     The overall rationale for this study is to evaluate the clinical performance potential for~     Mepilex Border Post-Op in the ability to minimise the risk of blistering, maceration and less~     dressing change due to high absorption capacity. This study is a part of Post Market Clinical~     Follow-Up (PMCF).~   "
131848|NCT01841554|"~     To evaluate the performance and safety of the Cardioband Adjustable Annuloplasty System for~     repair of functional mitral regurgitation.~   "
131849|NCT01841541|"~     Training and engaging of unpaid informal providers (such as tea-sellers, women's groups,~     youth clubs, small traders and religious groups) from poorer localities in TB disease~     recognition, referral and community awareness raising will increase the access of TB patients~     to formal health facilities and decrease their delay in initiating TB treatment.~   "
131850|NCT01841528|"~     Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders in women of~     childbearing age. However, the optimal infertility treatment for PCOS patients is still a~     matter of controversy. Despite producing more follicles and more oocytes than other women~     undergoing controlled ovarian hyperstimulation during an IVF cycle, women with PCOS have~     comparable or lower pregnancy rates. Additionally women with PCOS patients undergoing IVF~     have a higher risk of developing ovarian hyperstimulation syndrome (OHSS), which may be~     aggravated by pregnancy after an embryo transfer in a fresh cycle. Further women with PCOS~     are thought to have higher rates of later pregnancy complications including spontaneous~     abortion, pre-eclampsia, and preterm labor that may be related to impaired implantation in~     the superovulated endometrium. We propose a randomized clinical trial of elective embryo~     cryopreservation followed by a programmed cycle of endometrial preparation and frozen embryo~     transfer (FET) compared to fresh embryo transfer in women with PCOS undergoing in vitro~     fertilization (IVF).~   "
131851|NCT01841515|"~     Prolonged Collagen/Epinephrine - closure time (CEPI-CT) indicates platelet dysfunction in CKD~     patients taking antiplatelet agent. The synthetic vasopressin derivative, Desmopressin~     (DDAVP) shortens the prolonged bleeding time and improves platelet dysfunction measured by in~     vitro closure time: CEPI-CT in uremic patients. Desmopressin also antagonizes the in vitro~     platelet dysfunction induced by GPIIb/IIIa inhibitors, clopidogrel and aspirin. The~     investigators designed a prospective study to evaluate the effect of desmopressin on platelet~     function, as measured by in vitro collagen/epinephrine - closure time, in uremic patients who~     were taking antiplatelet drugs.~   "
131852|NCT01841502|"~     Hepatitis C (HCV) infected patients are often in need for an antidepressant. The introduction~     of Direct Acting Antivirals such as telaprevir has greatly improved treatment outcome of HCV~     infected patients.Telaprevir has been studied with one antidepressant, escitalopram: plasma~     concentrations of the antidepressant were reduced by 35% and without dose adjustment this may~     lead to inadequate treatment of depressive symptoms. There is a need for more data on~     telaprevir drug interactions with other antidepressants.~      For a number of reasons, paroxetine may be a good candidate for use together with~     telaprevir-containing HCV treatment.~      The interaction between paroxetine and telaprevir has not been studied before.~   "
131853|NCT01841489|"~     This is a Phase 1, Open-Label, Adaptive Study of Novel GS-9973 Tablet Formulations to~     Evaluate the Effect of Acid Reducing Agents, Relative Bioavailability, and Food Effect on~     GS-9973 Pharmacokinetics.~   "
131854|NCT01841476|"~     Phase I study to determine and compare the safety/tolerability of single ascending doses of~     POL6326 by intravenous infusion.~   "
131855|NCT01841463|"~     -  An Open Label, Multicenter, Phase I Extension Study of an Oral Cdk Inhibitor P1446A-05~          Administered with an Oral BRAF Inhibitor Vemurafenib (Zelboraf®) in Patients with~          Advanced or Inoperable Malignant Melanoma with BRAF Mutation~        -  The primary objective is to determine the safety, maximum tolerated dose (MTD), and dose~          limiting toxicity (DLT) of the co-administration of P1446A-05 with vemurafenib, in~          melanoma patients with BRAF mutation~   "
131856|NCT01841450|"~     The purpose of this study is to assess the long-term safety of the Glaukos® iStent®~     Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery vs. cataract~     surgery only, in subjects with mild to moderate open-angle glaucoma.~   "
131857|NCT01841437|"~     The purpose of this study is to observe the safety of the Glaukos® iStent® Trabecular~     Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery in subjects with mild to~     moderate open-angle glaucoma.~   "
131858|NCT01841424|"~     Obesity is becoming more common and disproportionately affects the younger generation, the~     poor and certain ethnic groups. Nearly 50% of reproductive aged women are obese or~     overweight. Obesity during pregnancy leads to higher rates of hypertensive disorders,~     stillbirth, less successful breastfeeding, obesity in their offspring, postpartum depression,~     and higher weight retention postpartum. Dietary counseling can prevent excessive maternal~     weight gain and is more effective than activity-based interventions. The two objectives of~     this study are 1) to use community-based techniques to improve dietary counseling for high~     risk women and 2) to randomize obese women to dietary counseling at Truman Medical Center and~     measure their success. The hypothesis is that dietary interventions can successfully be~     tailored for high risk women and that excessive weight gain during pregnancy can be avoided.~   "
131859|NCT01841411|"~     N-Acetyl cysteine (NAC) is an amino acid with strong antioxidant, mucolytic and antibacterial~     properties, and is produced within the human body.Its effect in biofilms has been tested in~     several bacteria. Biofilms have recently been observed in 90% of subjects with bacterial~     vaginosis (BV) with Gardnerella vaginalis being the predominant species. Although a wide~     range of antimicrobial agents are currently available, treatment options for controlling BV~     are still limited. Furthermore, the number of relapses are increasing and require alternative~     treatments. This study is aiming to evaluate the role of NAC in treatment of BV and~     prevention of recurrence.~   "
131860|NCT01841398|"~     People who originate from the Indian subcontinent known as South Asians are the fastest~     growing group of non-white Canadians. They suffer an excess prevalence of abdominal obesity,~     type 2 diabetes and heart disease. They also develop these risk factors at significantly~     lower body weight and at younger ages compared to people of European origin. The purpose of~     SAHARA (South Asian HeArt Risk Assessment) Trial, is to recruit 330 South Asians from Ontario~     (Principal Investigator: Dr. Sonia Anand) and British Columbia (Co-investigator: Dr. Scott~     Lear), who use the internet, email and other multimedia devices. Among these participants,~     the investigators will compare the effectiveness of a 12-month interactive multi-media health~     behaviour intervention to usual care in reducing cardiac risk factors. This intervention~     enables participants to set their health goals and provides health messaging and feedback~     designed to improve their smoking, dietary habits and physical activity. In addition, the~     investigators will test if knowledge of genetic risk for heart attack influences behaviour~     change and their heart health risk factor profile. The information generated from SAHARA will~     enable individuals, physicians, health professionals, and policy makers to develop risk~     factor modification programs to prevent cardiovascular disease in this high-risk group.~   "
131861|NCT01841385|"~     The aim of this study was to evaluate the influence of a fitness program from the application~     of Pilates on lung function, thoracoabdominal mobility and respiratory muscle strength in~     women.~   "
131866|NCT01841320|"~     This research examines the effectiveness of an intervention that employs seek, test, and~     treat strategies for Vietnamese injection drug users (IDU) and their network members, by~     ensuring that high risk individuals are sought for HIV testing and promptly referred to and~     maintained on antiretroviral therapy (ART). HIV prevention interventions are provided to IDUs~     who test HIV-negative, as well as those who test HIV-positive. HIV-positive IDUs will be~     referred to HIV care through a two-arm randomized controlled trial to compare the effects of~     different levels of engagement in care on ART uptake, ART adherence, and treatment outcome.~   "
131867|NCT01841307|"~     The overall purpose of this project is to develop and validate a simple, non-invasive method~     to detect aspiration of gastro-intestinal fluid into the respiratory tract. In the inpatient~     setting, the investigators will compare the quantity of cromolyn detected in urine collected~     overnight after 4 ingestions (at 2h intervals) of a 200 mL of a 1mg/mL solution of cromolyn~     sodium, by 5 healthy control subjects and 5 patients (3-6 with pulmonary fibrosis; and 3-6~     either awaiting or recently undergone lung transplantation) with clinical and laboratory~     evidence of GER (gastroesophageal reflux) with microaspiration. In the outpatient setting,~     the investigators will compare the quantity of cromolyn detected in urine collected overnight~     after 1 ingestions (at 4h intervals) of a 200 mL of a 1mg/mL solution of cromolyn sodium, by~     10 patients (3-6 with pulmonary fibrosis; and 3-6 either awaiting or recently undergone lung~     transplantation) with clinical and laboratory evidence of GER (gastroesophageal reflux) with~     microaspiration.~   "
131868|NCT01841294|"~     Surgical resection is the best treatment option for colorectal cancer. Despite this radical~     approach, recurrences within five years are still common. Several authors have proposed that~     the immunosuppressive state surrounding the perioperative period was a key element of cancer~     cells spread.~      A particular subtype of T lymphocytes, the Natural Killer cells (NKs), is the main actor of~     the innate immune system. Several factors of the perioperative period can reduce activity of~     NKs such as stress, pain, opioids and general anaesthetics.~      Lidocaine is a local anaesthetic that has been widely used intravenously for abdominal~     surgeries. Intravenous lidocaine has been shown to reduce pain scores, morphine consumption,~     ileus time and length of stay in major colorectal surgeries. It reduced markers of systemic~     inflammation as well.~      The authors hypothesize that the use of intravenous lidocaine during laparoscopic surgeries~     for colorectal cancer resection will preserve NKs activity.~   "
131869|NCT01841281|"~     The major impact of this study will be to identify the adult severe asthma cohort that will~     benefit from supplemental L-arginine therapy. The investigators hypothesize that a subset of~     adult severe asthma patients will respond to supplemental L-arginine and derive clinical~     benefit from the addition of this therapy to standard-of-care asthma medications. The~     investigators hypothesize that the patients that benefit most will have low exhaled nitric~     oxide concentrations (< 20 ppb) at baseline.~   "
131870|NCT01841268|"~     This study is designed to compare the skin lipid and protein composition between term and~     premature infants and determine how the skin composition changes over the first four weeks of~     life. The investigators hope to elucidate the unique characteristics of premature skin by~     measuring the lipid and protein content in skin, how it changes during the first month of~     life, and how it varies with formula feeding versus breast feeding. Additionally, the~     investigators will study the relationships among diet, skin composition and plasma lipids in~     premature infants over the first four weeks of life.~   "
131871|NCT01841255|"~     Background - Preoxygenation is performed before general anesthesia to increase the oxygen~     reserves of the body and prolong the safe period of apnea without hypoxia. However, it is~     often impossible to obtain a perfect face mask fit, and optimal end-tidal fractional oxygen~     concentration (EtO2) are not attained. The investigators designed a new oropharyngeal~     preoxygenation device, UMOX™, to avoid leaks during preoxygenation. In this study, the~     investigators compared the efficacy of UMOX™ with that of a conventional face mask.~      Methods - In 50 healthy volunteers breathing 100% oxygen from a circle absorber system for a~     5 minute-period, the investigators compared preoxygenation using the 1) a conventional mask;~     2) UMOX™ without any instruction; 3) UMOX™ with instruction on mouth breathing; and 4) UMOX™~     with a nose clip, in random order. Each subject underwent all steps with a 10-minute rest~     period of room air breathing between each step. Inspired and end-tidal respiratory gases were~     measured every 10 seconds. EtO2 variation was analyzed using Anova.~   "
131872|NCT01841242|"~     Heart Failure (HF) with systolic dysfunction is associated with a poor prognosis in the long~     term despite the use of many effective drug treatment in reducing morbidity and mortality. In~     this context, cardiac resynchronization (CR), either alone or combined with a defibrillator~     function, has improved by about 30 to 40% of morbidity and mortality in this population of~     patients with heart failure. The information on the CR are now well established for patients~     with stage III-IV NYHA (New York Heart Association), with systolic dysfunction (EF ≤ 35%),~     presence of left bundle branch block wide (≥ 120 ms) and when medical treatment is optimal.~     As a result, the number of implanted devices continue to grow even if the implant procedures~     of cardiac resynchronization devices (CRD) are long, difficult and associated with~     significant complications with a risk of reoperation estimated between 10 and 15% . One of~     the most feared during implantation devices stimulation or defibrillation risk is represented~     by the risk of infection that will lead inevitably to explantation of the device. Despite the~     use of several preventive measures, including the use of an antiseptic shower, a local~     preparation for alcoholic povidone iodine (API) (PVPI 5% ethanol + 70%) and antibiotic~     prophylaxis clinical studies the most recent have clearly demonstrated that the risk of~     infection was associated with the duration of the intervention and was higher for procedures~     CR, it is noted in 2.4% in the short term and would be close to 3 to 4% in the medium term.~     Infections of implantable devices are associated with a poor prognosis, even in an excess~     mortality. It has been shown that the majority of infections may be linked to local~     contamination during surgery reinforcing the idea that prevention is mainly based on local~     measures and the reduction of operating time.~   "
131873|NCT01841229|"~     Ginseng (American ginseng, Asian ginseng, Korean ginseng etc) is expected to show positive~     hypoglycemic effects, including improvements in glycated blood proteins[HbA1c], fasting~     glucose, fasting insulin, and the homeostasis model assessment of insulin resistance~     [HOMA-IR]).~   "
131941|NCT01840345|"~     This study will test whether treatment with N-acetyl-L-cysteine (NAC) is safe and decreases~     pain in patients with chronic neuropathic pain. The investigators hypothesize that NAC will~     be a useful adjunct to opioid treatment in chronic neuropathic pain.~   "
131942|NCT01840332|"~     The treatment of differentiated thyroid cancer (DCT) includes surgery followed by radioiodine~     treatment. In the follow-up of patients it is necessary to induce TSH elevation to test for~     cancer recurrence. One of the options is to stop L-thyroxin replacement for several weeks.~     Current pilot study aims to induce the necessary TSH elevation by decreasing the L-thyroxin~     dose. The main hypothesis is that necessary TSH stimulation will be achieved during 4-6 weeks~     in majority of patients.~   "
131874|NCT01841216|"~     The gluteus medius (Gmed) and gluteus maximus (Gmax) muscles are important components in the~     treatment of many lower limb injuries. Recent studies have evaluated a myriad of exercises~     which activate the Gmed and Gmax, but limited research remains on exercises involving~     resistance and the role of the TFL. The purpose of this study is to evaluate Gmed, Gmax, and~     TFL percent maximal voluntary isometric contraction (%MVIC) and perceived exertion in healthy~     and low back pain patients while performing exercises with and without resistance. Methods: A~     convenience sample of healthy subjects and patients diagnosed with non-radicular low back~     pain will be recruited. Exclusionary criteria will include: current low back or lower~     extremity injury (healthy group), pregnancy, history of hip surgery, and radicular symptoms.~     Surface electromyography will be used to quantify the activity level of the gluteal muscles~     and TFL while performing a series of 8 exercises with and without Thera-Band® Resistance~     Tubing and Stability Trainer. The maximal voluntary isometric contraction (MVIC) will be~     established for each muscle group and the order of exercises performed will be randomized to~     minimize the effect of fatigue. Following the completion of each exercise, the patient will~     rate their perceived exertion level on the Thera-Band® Resistance Intensity Scale for~     Exercise (RISE). The EMG signals will be smoothed and rectified and analyzed using a~     root-mean-square algorithm. Clinical Relevance: The results of this study will allow~     clinicians to better prescribe exercises, proven to activate the gluteal muscles and limit~     the TFL involvement, in the treatment of low back pain.~   "
131875|NCT01841203|"~     A dual POC immunoassay simultaneously detecting non-treponemal and treponemal antibodies was~     developed for the diagnosis of infections with T. pallidum. The assay is designed for use in~     resource-limited settings where challenging conditions (such as lack of electricity, running~     water, or laboratory equipment) commonly exist. We sought to compare performance of the~     dual-POC assay for diagnosis of yaws infection with that of the RPR and TPHA as reference~     standards.~   "
131876|NCT01841190|"~     The purpose of this study is to compare the tendency of plasma concentration and clearance of~     procalcitonin in the first 24 and 48 hours of management of patients with severe sepsis and~     septic shock with another marker of early prognosis represented by 48 hours delta sofa.~   "
131877|NCT01841177|"~     Children with congenital heart disease have significant morbidity including low cardiac~     output syndrome and subsequent organ dysfunction that may be prevented by optimization of~     circulatory function. More than half of these children receive milrinone. Clinical evaluation~     cannot distinguish between patients with sub-therapeutic, therapeutic, and toxic milrinone~     drug levels. Consequently children who require pharmacologic circulatory support may be~     receiving sub-optimal dosing, and children who do not need milrinone may be receiving~     milrinone unnecessarily. The primary objective of this study is to determine if optimizing~     milrinone levels with therapeutic drug monitoring in critically ill children following~     cardiac surgery improves clinical outcomes and reduces the duration of milrinone infusion.~     This study hypothesizes that optimizing milrinone levels with therapeutic drug monitoring in~     critically ill children following cardiac surgery will improve clinical outcomes and reduce~     the duration of milrinone infusion.~   "
131878|NCT01841164|"~     The trial is an investigator-driven research study in subjects with intermittent asthma, the~     aim of which is to explore the likelihood of a functionally important separate leukotriene E4~     (LTE4) receptor in airways and/or inflammatory cells in human subjects with asthma.~      Mostly on the basis of experiments in mice models, the prevailing view suggests that the~     present class of anti-leukotriene drugs are insufficient because they do not block the~     pro-inflammatory and bronchoconstrictive effects of LTE4. It is established by us and other~     groups that LTE4 is the most stable and long-lived leukotriene.~      The study will establish the effect of oral treatment with the highly selective~     CysLT1-receptor antagonist, montelukast, on bronchial responsiveness to inhaled LTE4 in~     subjects with intermittent asthma~   "
131879|NCT01841151|"~     The purpose of this study is to investigate if neurofeedback and working memory training~     improves core symptoms of ADHD in children and adolescents.~   "
131880|NCT01841138|"~     Hypothesis: Patients who undergo bowel preparation with PEG 3350 + ascorbic acid may have~     significant changes of serum electrolytes.~      A new PEG solution (Moviprep = PEG 3350 + ascorbic acid) for colonoscopy reduces the amount~     of cathartic solution to 2 liters, but requires drinking of additional liquid for optimal~     results. Ingestion of a high volume of free water bears a risk for severe changes of serum~     electrolytes, particularly for sodium and potassium.~      In this trial, patients undergo regular bowel preparation for standard colonoscopy with~     Moviprep (2 liters Moviprep split-dose plus ≥2 liters of free liquid until sufficient~     cleansing is achieved). Blood samples for serum sodium, potassium, chloride, magnesium,~     phosphate, calcium and serum osmolarity are taken before the beginning of the prep procedure~     and right before colonoscopy. The interval between both blood samples that will be compared~     is roughly 24 hours. Additionally, the volume of prep solution and additional liquid is~     recorded. The quality of bowel preparation is visually rated during colonoscopy with a~     validated score.~      Pre- and postpreparation serum parameters will be compared. Primary outcome measure is the~     proportion of patients who have a serum sodium beyond the reference values after the~     completion of bowel preparation. Secondary outcome parameters are the proportion of patients~     with other serum electrolytes or serum osmolarity beyond the reference. Moreover, changes of~     serum electrolytes and osmolarity will be correlated with the amount of prep solution and~     liquid.~   "
131881|NCT01841125|"~     Purpose : to Evaluation of the Efficacy of Escitalopram for the Treatment of Depression in~     Alzheimer's Disease~      Trial Design : A 12-week, randomized, double-blind, parallel-group, placebo-controlled trial~     with an open-label, 12-week extension~   "
131882|NCT01841112|"~     Safety, tolerability and pharmacokinetics of single and multiple oral doses of BI 409306~     tablets in healthy Chinese and Japanese male volunteers of a known genotype as specified in~     the study protocol.~   "
131943|NCT01840319|"~     The goal of this retrospective observational study is to collect only status survival data 30~     days after the last dose of treatment of patients included in the initial protocol WYETH~     3074A1-4448 / B1811030. The purpose is to estimate the survival status, 30 days after the~     last intake of tigecycline to patients hospitalized in ICU and treated by tigecycline.~   "
131883|NCT01841099|"~     Undernutrition is one of the most important health issues in Kenya. Children who are~     chronically undernourished do not reach their full potential and are at increased risk of~     infectious disease. Stunting occurs in a third of Kenyan children and has severe and~     long-term consequences in terms of health, development, and poverty. Several studies have~     shown that stunting is frequently associated with subclinical inflammation of the bowel, a~     condition referred to as Environmental Enteropathy (EE), previously known as 'tropical sprue'~     or 'tropical enteropathy'. EE is clinically similar to childhood inflammatory bowel diseases~     (IBD), including Crohn's disease. The treatment of IBD routinely involves provision of gut~     immunomodulatory agents, but this approach has never been tried in EE.~      This proposal outlines a pilot double-blind randomised placebo-controlled trial of mesalamine~     (also called mesalazine - the safest immunomodulator used in IBD with least systemic~     activity) in treatment of severely malnourished children with EE.~   "
131884|NCT01841086|"~     The purpose of this study is to evaluate the pharmacokinetics of sarpogrelate~     controlled-release formulation (CR) in comparison to immediate-release formulation (IR) and~     Food effect on the pharmacokinetics of sarpogrelate CR.~   "
131885|NCT01841073|"~     The rise in the prevalence of type 2 diabetes is related to recent lifestyle changes leading~     to a rise in obesity. Obesity is a risk factor for Impaired Glucose Tolerance (IGT) and~     diabetes. A type of fibre - fermentable carbohydrate - may help prevent diabetes in~     individuals with IGT by reducing appetite and food intake, and improving insulin sensitivity.~     Although fermentable carbohydrate is not absorbed in the small intestine it is full fermented~     by the colonic bacteria. The fermentation of this carbohydrate produces short chain fatty~     acids which act on specific G protein coupled receptors (GPR41/43) in the intestine to~     release GLP-1 and PYY. GLP-1 and PYY are hormones which act on appetite centres in the brain~     to decrease appetite. GLP-1 incretin effects and possible effect of the beta cell will~     increase insulin sensitivity. Short chain fatty acids also suppress the release of free fatty~     acids from adipocytes. Lower levels of free fatty acids in insulin resistant subject's leads~     to improved insulin sensitivity. This body of work will examine the effect of fermentable~     carbohydrate on appetite, weight loss, blood glucose control which will give an indication of~     the possibility of fermentable carbohydrate to prevent type 2 diabetes in this at-risk group.~   "
131886|NCT01841060|"~     Lung tumors of non-small cell stage 1A are usually treated surgically but many patients are~     not operable because of their condition or respiratory problems associated with it. The~     treatment is then suggested that local radiotherapy is conventionally carried out in split~     mode for 6 weeks at a dose of 60-65 Gy irradiation mode This exposes the patient to~     complications, including post-radiation pneumonitis.~   "
131887|NCT01841047|"~     Retro peritoneal liposarcomas are rare (less than 15% of sarcomas) whose prognosis is~     locoregional.~      In the treatment of retroperitoneal liposarcomas main prognostic factor is the quality of the~     surgical resection. The effect of radiotherapy combined with surgery is uncertain and until~     now limited perhaps because of limited prescribed doses (of the order of 45Gy to 50Gy) due to~     high risk of organ toxicity nearby.~      The helical tomotherapy is an innovative equipment radiotherapy to make conformational~     radiotherapy modulation intensity and is particularly suitable for irradiations precision~     (imaging mode associated with daily scanner) in large complex volumes. Increasing doses~     (increase of the prescribed dose to 54 Gy, thus potentially curative), the helical~     tomotherapy should allow to improve the efficacy of radiotherapy.~   "
131888|NCT01841034|"~     Male infertility is a multifactorial disease process with a number of potential contributive~     causes. Considering the majority of male infertility cases are due to deficient sperm~     production of unknown origin, environmental and nutritional factors must be evaluated. The~     purpose of this study is to evaluate the effects of 6 months antioxidant dietary complement~     (Conceptio) on sperm parameters (sperm count, motility and DNA fragmentation) in infertile~     men with oligoasthenozoospermia.~   "
131889|NCT01841021|"~     The main purpose of this study is to test if brentuximab vedotin has an effect on cancer in~     patients with a certain type of large B-cell lymphoma. The side effects (unwanted effects) of~     SGN-35 in patients with this certain type of large B-cell lymphoma will also be studied. It~     is not known if brentuximab vedotin is better or worse than other treatment patients might be~     given.~   "
131890|NCT01841008|"~     Tacrolimus ointment 0.1% has shown promising results for treating vitiligo in many~     prospective studies. Prospective randomized studies versus placebo are required to confirm~     the hypothesis that maintenance treatment with two applications of tacrolimus ointment 0.1%~     per week can reduce relapses of non-segmental vitiligo lesions.~      Main objective To assess the efficacy of maintenance therapy with topical tacrolimus vs~     placebo in the prevention of depigmentation in patients with vitiligo who responded to~     treatment.~      Secondary objectives~        -  Evaluate the efficacy of maintenance therapy with tacrolimus vs topical placebo to~          decrease the intensity of depigmentation in patients with vitiligo who responded to~          treatment.~        -  To study the occurrence of possible adverse effects.~      Length of the study Inclusion: 12 months Treatment: 6 months Follow-up: 6 months Total length~     of the study: 18 months~      Intervention Multicentric prospective interventional randomized comparative study versus~     placebo.~        -  Visit V0: Selection Information of the patient, control of inclusion and non inclusion~          criteria.~        -  Visit V1: Control of inclusion and non inclusion criteria, patients signed informed~          consent. An initial clinical evaluation and photographs in direct sunlight and UV.~          Topical treatment (tacrolimus or placebo) will be delivered to the patient by the~          hospital pharmacy and should be applied twice per week (3 or 4 days apart) for 24 weeks.~        -  Visit V2:~      The patient will be reviewed after the end of treatment (24 weeks after the visit V1) for~     final evaluation. A clinical assessment will be made and photographs in the same way as the~     inclusion. Adverse reactions during treatment will be collected by the investigator (they~     will be noted as and when the patient in a notebook that will be presented at baseline).~      The percentage of depigmentation will be evaluated in a blinded treatment of photographs by~     two reviewers. In case of disagreement, the opinion of a third appraiser will be required.~      - End of study: After the end of the study patients will be supported via the usual care~     recommended for their condition.~      Evaluation criteria~        -  primary endpoint~           ---Percentage of patients at 24 weeks without depigmentation (depigmentation score = 0).~          A score of depigmentation from 0 to 2 will be used. A blind treatment evaluation of~          direct light and UV photographs will be made by two independent observers~          (dermatologists) between inclusion and after 24 weeks of treatment.~        -  secondary endpoints~           ---- The efficiency to reduce the intensity of relapses will be evaluated using the~          score of depigmentation (rate of patients with a score of 0 or 1 in each group) and the~          VASI score (Appendix 4).~        -  The frequency, severity and time of occurrence of adverse events are reported. Side~          effects are classified into grades according to WHO criteria.~      Number of subject Considering that depigmentation occurs in more than 40% of patients during~     the 24 weeks of maintenance treatment and hoped that the proactive treatment will reduce the~     rate of depigmentation of 10%, a population of 26 patients per group will be necessary~     (taking into account 10% of patients lost to follow). The total number of patients to be~     included in the study will be 52.~   "
131891|NCT01840995|"~     The stellate ganglion block increase cerebral blood flow, as the consequence of that, it has~     the potential to cause an increase of intracranial pressure (ICP). Previous studies have~     proposed that ultrasonographic measurements of the optic nerve sheath diameter (ONSD)~     correlate with signs of increased ICP. Therefore, this study is aim to confirm the increased~     ICP by ultrasonographic measurement of ONSD after the stellate ganglion block.~   "
131892|NCT01840982|"~     This study was an open, 4-treatment, 5-sequence, 5-day cross-over randomized design clinical~     trial to evaluate the efficacy of mixed grain on blood glucose, insulin and Glycemic~     index(GI) in healthy males.~   "
131896|NCT01840930|"~      Cohort CP  is a multicentre cohort study, initiated by the Hospices Civils de Lyon in~     September 2009. Population targeted are children with bilateral cerebral palsy, level GMFCS~     IV or V, aged from 2 to 10 years at inclusion. They are followed-up during 10 years, at the~     rhythm of 1 visit per year. At each visit are collected clinical, orthopaedic, radiological~     and environmental data.~      The primary objective is to establish the incidence of orthopaedic complications (scoliosis~     and hip joint) depending on patients' age.~      Secondary objectives are to describe the sequences over time of these complications and the~     related pain, to explore the impact of nutrition, surgery, asymmetric postures and~     environmental factors, and to describe the medical and rehabilitative follow-up of these~     patients.~      385 patients are expected by the end of 2016. We expect of this long-term follow-up to gain~     tools that permit to improve patient's care and patient's quality of life, by putting in~     place preventing actions and adapted treatments related to their own pathologies.~   "
131897|NCT01840917|"~     The purpose of this study is to investigate heart rate variability during Acute uncomplicated~     diverticulitis by ECG-monitor (Holter), the investigators hypothesis is the inflammation~     causes a decrease of High Frequency(HF)-power component of heart rate variability and this~     correlates with sleep quality and daytime fatigue.~   "
131898|NCT01840904|"~     The purpose of this study is to investigate subjective sleep quality and fatigue during and~     after Acute uncomplicated diverticulitis assessed by questionnaires and a sleep-diary. The~     investigators hypothesis is that subjective sleep and fatigue are correlated with the~     inflammatory activities.~   "
131899|NCT01840891|"~     The objective of this study is to determine the prevalence of secondary lactose intolerance~     in renal transplant recipients (RTR) with chronic norovirus infection.~      In the investigators cohort of 1000 renal transplant recipients (RTRs) in the University~     Hospital of Zurich, the investigators are currently aware of 10 patients with chronic~     norovirus infection, which was proven by positive polymerase chain reaction (PCR) analysis of~     recent stool samples, whereas chronic virus shedding is defined as more than two PCR positive~     samples in an interval of at least one month. Concomitant viral (other than norovirus),~     bacterial or parasitic (particularly Gardia lamblia) intestinal infections are excluded by~     negative stool cultures and PCR analyses, respectively. Main exclusion criterion for the~     present case series is a concomitant intestinal infection (other than norovirus) and primary~     lactose intolerance, which is previously excluded by absence of the CC genotype of the DNA~     variant -13910 T/C upstream in the LCT gene. After obtaining written and oral informed~     consent, the investigators perform a lactose hydrogen breath (LH2BT) test and a lactose~     tolerance test (LTT) in all eligible RTRs with proven chronic norovirus infection~     irrespective of current abdominal symptoms.~      The study population (N=10) is divided into two groups according to the gastrointestinal~     symptoms (asymptomatic versus symptomatic, such as chronic diarrhoea or diffuse abdominal~     discomfort). The investigators chose the cut-off three or more stools per day as indicative~     of diarrhoea for the purpose of this study. RTRs with otherwise unexplainable chronic~     diarrhoea but absent norovirus infection serve as control group (N=10).~   "
131900|NCT01840878|"~     The purpose of this study is to investigate the accuracy of actigraph measured sleep compared~     to the golden standard (polysomnography) during Acute uncomplicated diverticulitis. Our~     hypothesis is the actigraph is accurate for sleep-monitoring for this group of patients~   "
131901|NCT01840865|"~     The beneficial effect of daytime sleep on memory consolidation has been shown in young,~     healthy subjects. Especially, periods rich in slow-wave sleep (SWS) have shown a memory~     enhancing effect on hippocampus-dependent declarative memory. Slow oscillatory activity~     typically occuring during SWS has been implicated in the consolidation effect. In this study~     we investigate if the consolidation effect can be amplified by the application of a weak~     transcranial oscillatory electric current within the frequency range of SWS in humans~     (0,7-0,8 Hz) during daytime SWS.~   "
131902|NCT01840852|"~     The purpose of this study is to investigate sleep disturbances during Acute uncomplicated~     diverticulitis by polysomnography. The investigators hypothesis is the inflammation causes~     REM(rapid eye movement)-sleep reduction and this is correlated with plasma cytokine levels.~   "
131903|NCT01840839|"~     The beneficial effect of nocturnal as well as daytime sleep on memory consolidation is~     well-documented in young, healthy subjects. Slow wave sleep (SWS), in particular, with its~     slow oscillating activity have shown to enhance declarative, hippocampus-dependent memory~     representations. This impact of sleep on memory performance can be additionally enhanced by~     exogeneous induction of transcranial slow oscillating stimulation (tSOS) within the frequency~     range of SWS in humans (0,7- 0,8 Hz) during sleep, as has been demonstrated in young, healthy~     subjects. If older adults that commonly experiencing cognitive decline, including long-term~     retention of declarative memory - benefit from transcranial slow oscillatory stimulation~     (tSOS) during sleep in the same way has not been studied so far. The primary goal of the~     study is therefore to investigate the impact of oscillating current stimulation (tSOS) during~     a daytime nap on declarative memory consolidation in older adults.~   "
131904|NCT01840826|"~     Project Re-Engineered Discharge (Project RED) has previously demonstrated that patients who~     received the RED were 30% less likely than patients receiving usual care to access inpatient~     or emergency services within 30 days of discharge. In this project, the investigators add a~     new dimension to RED by integrating screening, referral and treatment for depression into the~     original RED intervention and determining if this enhanced intervention increases the~     effectiveness of RED in preventing readmissions and controlling costs in the 180 days after~     discharge for patients with signs of depression.~   "
131905|NCT01840813|"~     Administration of intraumbilical misoprostol to women with retained placenta despite active~     management of third stage of labour reduces the need for manual removal of placenta and the~     amount of blood loss vaginally.~   "
131960|NCT01840098|"~     The purpose of this study is to investigate metabolic effects of 3 different nutritional~     compounds.~      Fasting (36 hours) creates a catabolic state that is comparable with the catabolic state seen~     in acute illness.~      This study is a randomized, placebo cross-over study investigating 8 healthy men on 4~     separated days (at least 3 weeks between trials).~        -  High leucine content drink~        -  Low leucine content drink~        -  Low leucine content drink + HMB~        -  Carbohydrate (isocaloric)~      The investigators hypothesize that these nutritional supplements may counteract catabolic~     processes in different ways and degrees.~   "
131906|NCT01840800|"~     Anterior cruciate ligament reconstruction is a routine surgical procedure. Traditional~     femoral/sciatic block combinations effectively reduce postoperative pain, but results in~     considerable motor blockade. The investigators aimed to evaluate postoperative pain relief~     and the degree of motor block with block combinations of femoral nerve (FEM) and obturator~     [posterior branch] nerve (ONP), versus saphenous nerve (SAPH) and ONP, versus placebo blocks~     with isotonic saline. All patients received standard patient controlled analgesia with~     morphine.Randomized, placebo-controlled and double-blinded clinical trial. Following IRB~     approval, 81 patients were planned to be randomized to one of three USG block combinations:~     Active FEM+ONP, active SAPH+ONP or no active blocks (sham blocks) Ropivacaine 0.75% was used~     for all active blocks following induction of general anaesthesia [propofol-remifentanil,~     laryngeal mask airway]. Primary outcome measure: Localized PACU pain scores (AUC) 0-6 hours~     postoperatively at rest.~      Secondary outcome measures: Opioid consumption, opioid related side effects, PACU time, motor~     abilities of daily living scores [modified Barthel/100 index], perceived ill health [Short~     form-8] scores and degree of motor blockade [Jensen- Børglum motor test].~   "
131907|NCT01840787|"~     As new contact lens products continue to be developed and improved, it's becoming harder for~     some individuals to tell whether one product is different from another. In addition, not~     everyone has the same level of sensitivity of their eyes, making it difficult for these~     judgments to be made. The purpose of this study is to explore the idea of using a~     pre-determined expert panel of individuals who are able to tell differences between contact~     lenses based on their comfort.~   "
131908|NCT01840774|"~     The purpose of this study is to determine how pain relief is modified when the investigators~     combine the Virtual Reality based Snow World game with certain pain medications.~   "
131909|NCT01840761|"~     Delayed vasospasm (DCVS) is the most serious complication of aneurysmal subarachnoid~     hemorrhage (aSAH) perioperative period ,the incidence rate up to 30% to 90%, and often can~     cause severe brain ischemia or brain damage of delayed ischemic and even lead to cerebral~     infarction, to be the main factor of deadly and severe disability . (aSAH) perioperative~     delayed vasospasm (CVS) is the bottleneck to restrict the long-term effect. Since there is no~     standard clinical treatment programs, limiting the advantages and characteristics of~     traditional Chinese medicine to play.Guangdong Provincial Hospital of TCM is the province's~     Medical Center encephalopathy, treated 100 brain aneurysm patients each year, more than 80~     times craniotomies and surgical interventions , with a rich source of patiengs to carry out~     the study. In this study, on the basis studies on hemorrhagic stroke of a yin and yang~     syndrome and comprehensive treatment programe of the State 1995,the 15th research , in~     accordance with characteristics of the pathophysiology and understanding of cause and~     pathogenesis in aSAH perioperative period , through expert advice and review of the~     literature, under the guidance of Liu Maocai who isChinese medicine practitioners of~     Guangdong province , from diagnosis, diagnosis and treatment,prescription drugs, and other~     aspects of efficacy evaluation, developmenting a standardized treatment program of delayed~     CVS after aSAH . To evaluate the efficacy of the standardized program by prospective,~     randomized,controlled clinical trial,improving the postoperative results, reducting~     significantly the mortality and morbidity patients with cerebral aneurysms.~   "
131910|NCT01840748|"~     Systemic sclerosis (SSc) is an orphan, multiorgan disease affecting the connective tissue of~     the skin and several internal organs.~      Pulmonary hypertension (PH) is a fatal disorder characterized by an increase in pulmonary~     vascular resistance, which leads to right ventricular failure. Despite being recently the~     object of greater attention and despite therapeutic advances, pulmonary hypertension due to~     SSc remains associated with a dismal 47 - 67% 3-year survival. Among SSc patients~     prospectively followed in the European League Against Rheumatism Scleroderma Trials and~     Research (EUSTAR) cohort, 26% of death was related to pulmonary hypertension. Although some~     previous data have suggested the protective effects of calcium channel blockers on the~     development of pulmonary hypertension, the potential preventive effects of vasodilators for~     the prevention of Pulmonary hypertension have not been determined yet. In addition to be~     considered routinely for the treatment of SSc-related pulmonary hypertension, prostanoids,~     endothelin receptor antagonists (ETRA) and Phosphodiesterase-5 inhibitors (PDE5i) can also be~     used for this indication.~      This observational trial is one out of five observational trials of the collaborative project~     To decipher the optimal management of systemic sclerosis (DeSScipher).~      Aim of this observational trial is:~      - to compare the outcomes of adult and juvenile SSc patients who are at high risk of~     developing pulmonary hypertension and are receiving either different vasodilator treatments~     or no vasodilator treatment.~   "
131911|NCT01840735|"~     This study will determine the safety, tolerability, and pharmacokinetics of a single dose of~     GS-5737 administered with a 2.8% saline solution vehicle in adult subjects with CF.~   "
131912|NCT01840722|"~     The overall aim of this study is to reduce risk behaviors and increase health and behavioral~     health service utilization among disadvantaged, drug-using rural women at high risk for HIV~     and HCV. This project has potential to make a significant contribution to science by~     providing knowledge about the health, risk behaviors, and service utilization of a vulnerable~     and understudied group of women during a time of emerging and significant public health risk~     in a rural Appalachian setting. Successful completion of the aims of this project will~     advance the delivery of a low-cost, potentially high impact intervention with implications~     for a number of other real world settings (such as criminal justice venues) where other~     disadvantaged high-risk drug users can be identified and targeted for intervention.~   "
131913|NCT01840709|"~     Psychosomatic is a new approach to understanding the phenomena of somatization using the~     knowledge of medicine and psychology to treat human being. A Brief Group Psychanalytic~     Psychotherapy (BGPP) for psychosomatic patients has been used to supplement the treatment of~     some diseases including Systemic Lupus Erythematosus (SLE). The hypothesis of the study is~     that BGPP beside clinical treatment can improve the quality of life and coping in SLE~     patients. The aim of the study is to evaluate the effectiveness of BGPP in Brazilian SLE~     patients.~      Primary objective: To evaluate the effectiveness of BGPP to improve quality of life.~     Secondary objectives: To evaluate the effectiveness of BGPP to improve coping, anxiety and~     depression symptoms. SLE patients will be randomized to receive Psychotherapy or only~     clinical treatment. The effectiveness will be assessed through specific questionnaires.~   "
131914|NCT01840696|"~     Rubidium myocardial perfusion PET is an imaging test used to diagnose patients with abnormal~     blood flow to the heart secondary to narrowing of the heart vessels.~      Phase analysis is a computer method that is applied after the PET test is done. It is used to~     determine when a region of the heart contracts relative to other heart regions in the heart~     beating cycle. Initial data suggest that regions of the heart with abnormal blood flow change~     the pattern of contraction from rest to stress conditions. That is, regions of the heart with~     abnormal blood supply become dyssynchronous when compared to the normal regions of the heart.~      This study will investigate whether phase analysis may aid the visual interpretation of~     rubidium myocardial perfusion PET studies by determining the areas of the heart that are not~     beating in synchrony with the normal heart regions. This information will be used as a proxy~     for poor blood supply. The gold standard will be coronary angiography by which the percent~     narrowing of the heart vessels is assessed.~   "
131915|NCT01840683|"~     This is an open-label, single center clinical investigation to evaluate the efficacy and~     safety of Heparin-induced Extracorporeal Lipoprotein Precipitation (H.E.L.P.) Therapy as a~     treatment for non-exudative (dry) Age-related Macular Degeneration (AMD). A total of 14~     clinic visits are scheduled, one baseline visit, 8 visits for H.E.L.P. therapy treatments (to~     be performed over a period of 12 weeks for each patient) and 5 follow-up visits to be~     performed one week following the 4th H.E.L.P. therapy session and 12 weeks, 24 weeks, 36~     weeks and 52 weeks after the final H.E.L.P. therapy session.~   "
131916|NCT01840670|"~     The elliptic shape of inferior vena cava (IVC) sections, while hindering the ultrasound~     measurement of IVC diameter, may provide a useful tool to estimate central venous pressure~     (CVP). Hypothetically, the higher is CVP and more the ratio R between minimum and maximum~     diameters approximates 1. The purpose of this study is to determine R values in four~     different sections before and after a fluid load test, in order to evaluate if R is affected~     by the test and at which level the variation is larger.~      The secondary endpoint is to search for the parameter best predictive of the positivity of~     the fluid load test among IVC minimum and maximum diameters, eccentricity, section area, and~     blood velocity at the level that presented the largest variations after the fluid load.~   "
131917|NCT01840657|"~     X-Linked myotubular myopathy (XLMTM), a form of centronuclear myopathy (CNM) is the result of~     a mutation in the MTM1 (myotubularin) gene which leads to altered myotubularin. Myotubularin~     is essential for optimum muscle function. To date, over 100 mutations have been described~     resulting in a range of disease onset and symptom severity. The early onset form presents~     with neonatal hypotonia, muscle weakness, respiratory distress and an ongoing requirement for~     continuous ventilatory support with the inability to maintain a sitting position once placed.~     Males with both later onset and milder symptoms usually do not require ongoing ventilatory~     support, achieve a higher maximal motor function with ability to sit when placed and even~     walk, and have improved survival rates. Males with XLMTM may experience complications~     (events) at birth and throughout their lifetime. The goal of the study is to identify the~     number of events over twelve months in males with genetically confirmed XLMTM. Parents or~     affected individuals over the age of 18 years who are able to access telephone will provide~     answers to an established event survey to evaluate the frequency and types of events.~     Emergency department, hospital admissions and mortality will be confirmed by obtaining~     medical reports.~      The investigators hypothesize that there will be no association between the frequency of~     events and markers of clinical severity including the need for ventilatory support at birth,~     current level of ventilatory support (no support, support less than 12 hours, support more~     than 12 hours) and current motor function (walking, sitting without support, inability to sit~     without support).~   "
131918|NCT01840644|"~     The purpose of this study is to examine the reliability and validity of the rating of~     perceived exertion scale in children post severe traumatic brain injury during treadmill~     exercise.~   "
131919|NCT01840631|"~     Aim 1 - The primary aim of our study is to assess whether group counseling is a non-inferior~     intervention compared to the usual care of individual counseling in the management of~     childhood obesity. In order to achieve this aim, the investigators will compare the mean~     change in BMI after 6 months of intervention in the two study arms.~      Aim 2 - The secondary aim of our study is to determine if the change in BMI is associated~     with changes in the dietary composition, physical activity and metabolic profile.~   "
131920|NCT01840618|"~     Polycystic ovary syndrome (PCOS) is one of the most common disease caused by hormonal~     imbalance and is also associated with overweight and obesity. It affects 5-10% of adolescent~     girls and women capable of having children. Polycystic ovary syndrome is associated with~     missed menstrual periods, hormonal imbalance, being overweight, and with a form of diabetes.~     Girls with polycystic ovary syndrome may have a breathing problem known as sleep apnea.~     Sleep apnea may cause a person to stop breathing for short periods of time while sleeping.~     People with polycystic ovary syndrome are thirty times more likely to develop sleep apnea~     than those who do not have PCOS. If sleep apnea is not treated, it may lead to daytime~     sleepiness, poor school performance, high blood pressure, heart disease and diabetes. The~     purpose of this study is to understand how insulin function is affected in presence of sleep~     apnea in girls with polycystic ovary syndrome between 13-21 years of age as compared to girls~     with PCOS without sleep apnea. Insulin is one of the hormones made in your body to convert~     food into energy. In people with increase weight body cannot use insulin properly. The~     investigators also want to see if insulin action is also affected by sleep apnea.~   "
131921|NCT01840605|"~     The objective of this study is to verify the non-inferiority of TAU-284 to ketotifen fumarate~     dry syrup in the change in the severity of pruritus after the treatment period.~   "
131922|NCT01840592|"~     The purpose of this study is to find out what effects, good and/or bad, the combination of~     the drug sorafenib in combination with the drug doxorubicin might have on the growth and~     spread of liver cancer (HCC).~   "
131961|NCT01840085|"~     To evaluate the safety of topical 0.03% DSC127 Gel when used for one or more continuous~     treatment periods on a chronic Wagner Grade 1 or 2 foot ulcer(target ulcer) or multiple~     ulcers in diabetic subjects. The maximum duration of any treatment period is 24 weeks.~   "
131962|NCT01840072|"~     This randomized trial tests the effect of early blood pressure reduction on major disability~     and death among patients with acute ischemic stroke in china.~   "
131923|NCT01840579|"~     This study using pembrolizumab (MK-3475) will be done in 5 parts. In Part A, successive~     participant cohorts with advanced solid tumors will receive pembrolizumab to assess the~     safety and tolerability of monotherapy. In Parts B, C, and D, participants with advanced~     non-small cell lung cancer (NSCLC) will receive pembrolizumab in combination with either~     cisplatin/pemetrexed or carboplatin/pemetrexed (Part B); with either carboplatin/paclitaxel~     or carboplatin/nab-paclitaxel (Part C); or with ipilimumab (Part D) by non-random assignment~     to assess the safety and tolerability of the combination therapy. In Part E, participants~     with untreated Extensive-disease (ED) Small Cell Lung Cancer (SCLC) will receive~     pembrolizumab in combination with either cisplatin/etoposide, carboplatin/etoposide, or~     cisplatin/etoposide with prophylactic use of granulocyte colony-stimulating factor (lasting~     G-CSF [pegfilgrastim]) by non-random assignment to assess the safety and tolerability of the~     combination therapy.~   "
131924|NCT01840566|"~     The purpose of this study is to test the safety of delivering the patients' own immune cells,~     called T cells, after the high-dose chemotherapy (HDT) and autologous stem cell~     transplantation (ASCT).~   "
131925|NCT01840553|"~     The purpose of this study is to evaluate the efficacy and safety of sodium phosphate tablets~     compared to split dose of 4 liters of PEG used in adults for bowel cleansing prior to~     colonoscopy.~   "
131926|NCT01840540|"~     To determine the safety and toxicity of intra-arterial infused autologous adipose derived~     mesenchymal stromal (stem) cells in patients with vascular occlusive disease of the kidney.~   "
131927|NCT01840527|"~     This primary purpose of this study is to obtain blood samples from participants with both~     early and later stages of melanoma (Stage II/III and Stage IV). The researchers hope to~     better understand an abnormal protein found in many melanoma tumors called the BRAFV600~     mutation.~      There will be two separate cohorts (groups) of participants on this study. You will be placed~     in one of the Groups.~      Group 1-For participants with advanced melanoma: Your existing tumor tissue sample will be~     compared to the blood samples given in order to further analyze and to understand the~     BRAFV600E gene mutation.~      Group 2-For participants with stage II/III melanoma: Following surgery, blood samples will be~     collected and analyzed.~      Understanding the BRAFV600E gene mutation in melanoma will help the researchers better~     understand the disease, and help plan treatment options for people with melanoma of all~     stages in the future.~   "
131928|NCT01840514|"~     The stress of orthotopic living donor liver transplantation in patients with cirrhosis could~     induce worsening of an already recorded myocardial dysfunction or may be associated with a~     new myocardial dysfunction in patients previously having normal myocardial functions,~     therefore this study will be designed for intra-operative detection of new onset ventricular~     dysfunction or worsening of already diagnosed ventricular dysfunction in living donor liver~     transplant recipient and the possible contribution of several hemodynamic and oxygenation~     parameters in the generation of any cardiovascular function impairment will be also~     investigated and to determine the impact of ventricular dysfunction on early (7 PO days)~     graft function, 28 days survival and patient outcomes.~   "
131929|NCT01840501|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (what the~     body does to the medication), potential immunogenicity (ability to induce an immune~     response), and pharmacodynamics (what the drug does to the body) after administration of~     JNJ-42721458 in healthy adult male participants.~   "
131930|NCT01840488|"~     The purpose of this study is to determine the optimal biological dose (OBD) of Irosustat~     (BN83495) in postmenopausal women with oestrogen receptor (ER) positive locally advanced or~     metastatic breast cancer with disease progression after prior hormonal therapy.~      This study is designed to provide necessary information on safety and dose response of~     BN83495, when given by repeated once daily oral administration, while achieving a maximal STS~     inhibition and a maximal reduction in plasma oestradiol (E2) and adiol levels. The data~     obtained will be used to plan further clinical studies.~   "
131931|NCT01840475|"~     Botulinum toxin A (BoNT-A) is effective and safe in alleviating post-stroke spasticity and~     reducing the burden of associated symptoms.~      The hypothesis for this non-interventional study in arm spasticity (AS-NIS early BIRD) is no~     significant difference between naïve and pre-treated patients. The patients will be divided~     in sub-groups according to the time interval between occurrence of stroke and start of~     treatment (early, medium and late start of treatment according to the first and third~     quartiles time distribution). It is hypothesized that the early start of treatment group~     will have a reduced modified Ashworth scale (MAS) on the elbow and wrist flexors when~     compared to the late start of treatment group.~   "
131932|NCT01840462|"~     The objective of this study is to investigate the efficacy of Dysport® in the treatment of~     cervical dystonia (CD) in a non-interventional long-term study in naïve and pre-treated~     patients.~   "
131933|NCT01840449|"~     The aim of the study is to identify predictive factors for the response to Lanreotide~     treatment in Acromegaly as well as in Neuroendocrine Tumours.~   "
131934|NCT01840436|"~     MUCIPLIQ is a nanopolymer engineered to mimic glycosaminoglycans such as heparan sulfates.~     Glycosaminoglycans are involved 1) in the stabilization of cells micro-environment, known as~     extracellular matrix, by binding to structural proteins, and 2) in cells communication~     process by protecting growth factors. At the site of a lesion, glycosaminoglycans are~     degraded, thereby the extracellular matrix is disorganized and the tissue is destroyed. By~     replacing damaged glycosaminoglycans, MUCIPLIQ provides a protection, and restores the matrix~     scaffold and cells communication, a process known as Matrix Therapy.~      The purpose of this new controlled study is to determine whether MUCIPLIQ can decrease the~     incidence and the severity of radio-chemotherapy-induced mucositis in patients suffering of~     upper aerodigestive tract cancers, when used as a preventive agent.~      The study's main hypothesis is that MUCIPLIQ mouthwash applications before radiotherapy would~     protect the healthy oral tissue against cytotoxic effect of chemotherapy and radiations.~   "
131935|NCT01840423|"~     The purpose of this study is to evaluate the safety and tolerability of escalating doses of~     ODM-104 when given to healthy male volunteers.~   "
131936|NCT01840410|"~     This study was conducted to evaluate the efficacy and safety of 0.5 mg ranibizumab in adult~     and adolescent patients with visual impairment due to choridal neovascularization (CNV).~   "
131937|NCT01840397|"~     The hypothesis of this study is to find evidence if there is an influence of spine surgery on~     the serum levels of two proteins secreted from neuronal cells.~   "
131944|NCT01840306|"~     Primary Objective:~      (i) To identify panels of RNAs and proteins predictive of response to HER2 targeted agents,~     considering clinical responses. (ii) To investigate associations between presence vs. absence~     (or relative levels) of identified extracellular (EC) RNAs/proteins and patients'~     clinicopathological characteristics, including age at diagnosis, time to progression and~     overall survival, as well as correlations with serum protein biomarkers routinely analysed~     for these patients. (iii) To compare HER2 positive samples versus HER2 negative samples for~     the existence of RNAs/proteins identified in (i) and (ii).~      Secondary Objective:~      To develop a predictive model for use in the HER2 positive population based on the most~     accurate and sensitive combination of the identified biomarkers.~   "
131945|NCT01840293|"~     Primary objective:~      The primary objective is to define the proteomic and molecular characteristics of primary and~     recurrent/ metastatic breast tumours with special focus on the expression of S100 protein and~     the estrogen receptor (ER), progesterone receptor (PR) and epidermal growth factor receptor 2~     (HER2) genes~      Secondary objective:~        -  To expand our understanding of the complex molecular pathways dictating the progression~          of breast cancer and their response to different treatment regimes.~        -  To relate proteomic findings to survival data~        -  To identify potential serum markers of breast cancer progression~   "
131946|NCT01840280|"~     The main purpose of this observational study with Irinotecan onkovis is to determine the~     number of treatment cycles and the quantity of Irinotecan onkovis needed for this purpose~     under the special circumstances of ambulant chemotherapy.~      Onkovis aims to contribute to an economical utilization of the chemotherapeutics. This~     includes provision of appropriate packaging sizes to decrease the excess quantity to be~     discarded, and thus also follows this objective.~      Secondary objective is the assessment of the side effects of Irinotecan onkovis. To this end,~     data regarding co-medication and adverse events are also collected.~   "
131947|NCT01840267|"~     The pneumoperitoneum during laparoscopic surgery in pediatrics has the potential to cause an~     increase of intracranial pressure (ICP). Previous studies have proposed that ultrasonographic~     measurements of the optic nerve sheath diameter (ONSD) correlate with signs of increased ICP.~     Therefore, this study aims to confirm the increased ICP by ultrasonographic measurement of~     ONSD during laparoscopic surgery in pediatric patients.~   "
131948|NCT01840254|"~     The aim of this study is to test the hypothesis that addition of dexmedetomidine to~     fentanyl-based intravenous patient controlled analgesia (PCA) reduces requirement of fentanyl~     bolus and consequent postoperative nausea and vomiting in high-risk patients undergoing~     lumbar spine surgery.~   "
131949|NCT01840241|"~     In this single-site, randomized, controlled and double-blind clinical trial, the~     investigators evaluate the effect of sodium bicarbonate on prevention of acute kidney injury~     in high risk patients undergoing off pump coronary bypass surgery.~   "
131950|NCT01840228|"~     Preterm birth, defined as birth before 37 weeks' gestation, is a leading cause of infant~     death and disease. Progesterone is the single most effective intervention in the prevention~     of preterm birth. However, current use of this therapy is limited to certain high-risk groups~     including women with a history of preterm birth and women with a short cervix. This study~     seeks to evaluate the efficacy of this preventive therapy in another high-risk group: women~     with arrested preterm labor. The investigators hypothesize that administration of vaginal~     progesterone in women who present with preterm labor but remain undelivered 12 hours after~     cessation of short-term therapy to inhibit contractions will result in lower rates of preterm~     birth before 37 weeks' than will administration of placebo.~   "
131951|NCT01840215|"~     Anaesthetic procedures in ophthalmology surgery have been a subject rapidly evolving in the~     past decades. When deciding for a retrobulbar block, the local injection of varying mixtures~     and volumes of fast-acting anesthetics (such as lidocaine) - with or without a~     vasoconstrictive agent (such as adrenaline) - coupled with Hyaluronidase have been the~     standard care to provide painless surgery while minimizing the possible risks such as~     increased intraocular pressure (IOP), brainstem anesthesia, toxic reaction and ocular blood~     flow changes. These iatrogenic-induced vascular dysfunctions have been also suggested to play~     a role in intra-operatory vision loss (a wipe-out phenomenon) in patients with advanced~     glaucoma.~      The rationale for the use of epinephrine in retrobulbar anesthesia is to slow absorption of~     the anesthetic in general circulation and thus to achieve a longer effect in the orbit.~     However, studies on ocular blood flow after adrenaline-containing compounds have consistently~     showed a decrease in ocular blood flow, thus raising the issue of whether it should be used~     in patients with known vascular dysfunction, namely glaucoma patients. Nevertheless, there~     has been no study to verify this claim concerning the safety of non-adrenaline containing~     anesthetics.~      Injecting a pre-determined volume of anesthetic compound behind the globe, regardless of its~     formulation has also been debated. The orbital pressure increase can lead to a number of~     adverse reactions, not only increasing IOP but also potentially decreasing vascular input by~     local compression. In glaucoma for instance, there has been suggested optic nerve sheaths to~     be less elastic than in healthy individuals, potentially making this structure less compliant~     to outside compression. These more rigid orbital tissues could also impair the orbit's~     ability to deal with the iatrogenic increased volume.~      As seen, the current concepts on the impact of ocular anesthesiology in the orbit and the~     vascular supply to the eye are limited to a small number of non-homogeneous studies. We aim~     to study this impact through a non-invasive, widely established ultrasound based method of~     ocular blood flow research (color Doppler Imaging). Potentially, our study could help~     determine a taylor-made choice of the anesthesiology procedure to apply to a specific~     patient, thereby advancing the current standard of care in ophthalmology.~   "
131952|NCT01840202|"~     Glaucoma is a leading cause of blindness worldwide, whose treatment - intraocular pressure~     lowering - is only partially effective in preventing disease progression. Accordingly, other~     variables, such as ocular blood flow-related factors, have been implicated in disease~     pathogenesis. However, most findings involving vascular variables come from partial,~     small-scale studies. Furthermore, recent technological advances have identified a number of~     ocular blood flow variables that have yet to be tested in large scale trials. Therefore, a~     study that specifically aims at uncovering the role of vascular aspects in glaucoma is~     needed.~      For this purpose, a cross-sectional, observational case-control study will be conducted in~     the University Hospitals Leuven. This will be the largest-yet study on the subject, involving~     more than 750 patients. This will allow the creation of a specific cohort of patients where~     the vascular aspects are thought to be particularly important (low-tension glaucoma). It will~     use the largest combination yet of vascular-related measuring techniques (dynamic contour~     tonometry, optic coherent tomography, colour Doppler imaging and retinal oximetry)~   "
131963|NCT01840059|"~     The purpose of this study is to determine whether renal sympathetic denervation (RSD)(a~     treatment that lowers the activity of the sympathetic nervous system) is useful in the~     management of patients with heart failure with preserved ejection fraction (HF-PEF).~   "
131953|NCT01840189|"~     The conventional glucocorticoid replacement therapy in primary adrenal insufficiency~     (Addison's disease) renders the cortisol levels unphysiological, which may cause symptoms and~     long-term complications.~      The majority of Addison's patients have other organ-specific autoimmune disease, which poses~     challenges to the replacement therapy. Of particular interest is the combination of Addison`s~     disease and type 1 diabetes, since cortisol affects glucose homeostasis. The clinical~     experience is that this subgroup of patients is difficult to treat, but very little research~     has been done to understand and improve their situation.~      Glucocorticoid replacement is technically feasible by continuous subcutaneous hydrocortisone~     infusion, and can mimic the normal diurnal cortisol rhythm. This pilot study aims to further~     evaluate continuous subcutaneous hydrocortisone infusion treatment in terms of metabolic~     effects especially glycemic control in patients with the combination of Addison`s disease and~     type 1 diabetes in an 5 months cross-over design open clinical pilot study.~   "
131954|NCT01840176|"~     The purpose of this study is to assess the feasibility of performing prophylactic McCall~     culdoplasty at the time of total laparoscopic hysterectomy. The investigators will also be~     measuring pelvic support (using POP-Q) and sexual function before and at different time~     points (up to 12 months) postoperatively.~      The investigators hypothesize that women undergoing the McCall culdoplasty will not have~     different immediate surgical outcomes (operative time, etc) and may have better pelvic~     support and sexual function in the future.~   "
131955|NCT01840163|"~     This study examines the impact of an online decision tool for patients with early stage~     invasive breast cancer. The study is a randomized controlled trial (RCT) of 444 newly~     diagnosed patients, recruited from multiple surgical practices in two SEER catchment areas.~     Participants will be randomized to receive either a basic version of a decision tool (similar~     to existing website with breast cancer information) or an enhanced version (featuring a~     knowledge building component, a values clarification exercise, and a patient activation~     module). Our hypothesis is that patients who use the enhanced version of the tool will have~     greater knowledge of their test and treatment options, have a higher rate of high quality~     (i.e., informed, preference-concordant) decisions, and report more positive appraisal of the~     decision-making process.~   "
131956|NCT01840150|"~     This clinical trial studies nanoscale artificial nose (NA-NOSE) in monitoring response and~     detecting recurrence after surgery or radiation therapy in patients with stage I or stage II~     non-small cell lung cancer (NSCLC). Using the NA-NOSE breath test may be an effective way to~     monitor response and detect recurrence of NSCLC after surgery or radiation therapy.~   "
131957|NCT01840137|"~     The development of clinically relevant and scalable exercise interventions in older~     cystectomy patients may have an impact upon:~        -  Patients: Exercise interventions may improve patient outcomes, including quality of life~          and avoidance of skilled nursing facilities.~        -  Clinicians: Proving the safety and feasibility of targeted interventions in older~          surgical patients may facilitate the development of clinically relevant preoperative~          interventions suitable for wider study and implementation.~        -  Payers: Improved surgical outcomes among high risk surgical patients will be associated~          with significant cost savings.~        -  Researchers: Targeted and well controlled studies focusing on improving surgical~          outcomes through exercise may provide insight into relationships between patient~          factors, surgical stressors and outcomes. Ultimately, such work may lead to novel~          clinical approaches to optimize patients for surgery.~      The investigators will study the effects of preoperative exercise training on cystectomy~     patients, specifically targeting increasing functional capacity and muscular strength. Prior~     to conducting a more extensive, multi-center, randomized-controlled trial, the feasibility,~     safety, and initial efficacy of preoperative exercise in cystectomy patients must be~     determined. To address this issue, the investigators will complete a trial of rehabilitation~     in cystectomy patients at the University of Michigan.~   "
131958|NCT01840124|"~     The ULTRA study is a single-arm trial of 100 premenopausal women with symptomatic uterine~     fibroids who undergo treatment with the Acessa device. The Acessa device is a new FDA~     approved minimally invasive treatment for uterine fibroids that uses radiofrequency energy to~     destroy fibroid tissue. The fibroids then shrink and symptoms are significantly improved. The~     radiofrequency energy is delivered to the fibroids during an outpatient surgical procedure.~     There is minimal blood loss and pain and women return to the usual activities 5-9 days after~     the Acessa procedure.~      The investigators will evaluate changes in fibroid-related symptoms from before the Acessa~     treatment to 3, 6, 12, 18, 24, 30, and 36 months after Acessa treatment. The investigators~     will also assess operative outcomes including procedure duration, complications, blood loss,~     post-operative pain, and the time to return to usual activities. The investigators will~     determine long-term efficacy of Acessa by evaluating the rate of re-treatment for symptomatic~     fibroids after the Acessa procedure.~      Study participants will be recruited at 5 sites within the UC Fibroid Network: UC Davis, UC~     Irvine, UC Los Angeles, UC San Diego, and UC San Francisco. UC San Francisco will serve as~     the Coordinating Center for the trial with oversight of all scientific and administrative~     aspects of the study. All study data will be stored securely in a HIPAA compliant, secure~     database monitored by the UC San Francisco Coordinating Center. A data safety and monitoring~     board will oversee participant safety and protection.~   "
131959|NCT01840111|"~     The overarching goals of this proposal are to 1) identify the network of brain regions~     specifically activated by personal smoking environment cues and 2) to evaluate the effects of~     exposure to these cues on smoke self-administration and subjective reactivity. The results of~     this study will inform the development of novel and more efficacious cue-exposures therapies~     targeted at helping smokers quit smoking and will provide novel mechanism information~     regarding the influence of environmental context on drug taking.~      The investigator hypothesizes that cue-exposure treatments (CETs), in which drug use is~     prevented during exposure to drug cues (e.g. lit cigarette) have been of limited efficacy in~     part because they have not included cues representative of the contexts in which drug use~     occurs. By demonstrating that context cues have a differential and robust influence on brain~     and behavioral responses, we will have provided a substantial basis for including such~     stimuli in the context of treatment. At the same time, we will have identified novel~     mechanisms by which such stimuli promote continued drug use and relapse.~   "
131964|NCT01840046|"~     Alopecia areata is an autoimmune disease associated with infiltration of cluster of~     differentiation 4(CD4 +) and cluster of differentiation 8 (CD8) + cells around the hair~     follicles. One of the therapeutic approaches of inflammatory diseases such as alopecia areata~     is the induction of tolerance. This tolerance induction can be obtained by stimulating~     regulatory T cells (Treg). The low-dose interleukin-2 plays a central role in the~     development, expansion, regulation and survival of regulatory T cells CD4 + cluster of~     differentiation 25 (CD25) + forkhead box protein 3 (FoxP3). Recently, recombinant interleukin~     2 (IL2-R) with low dose showed very promising results in two inflammatory disease (GVHD~     vasculitis and cryoglobulinemia secondary to hepatitis C): clinical efficacy, increased~     population Treg in the blood and an excellent safety profile. We hypothesized that~     administration of IL2-R in patients with severe alopecia areata might allow regrowth via~     activation of Treg and thus induce regrowth of the air.~   "
131965|NCT01840033|"~     Home parenteral nutrition (HPN) is the reference treatment for anatomic or fonctionnal~     chronic intestinal failure. Nutritionnal catheter must follow two rules: low infection rate~     and be able to preserve the permeability of the central vein. Today, in europeen guidelines,~     two types of central devices are recommended: tunnelled central catheter with cuff and~     implanted ports. However, their insertion is not without risk. Since many years, we have seen~     a new generation of catheter - peripherally inserted central catheter (PICC line)- which have~     many advantage over other central catheter. ESPEN guidelines accept the use of PICC line in~     short and moderate-term for HPN, but no prospective study have look for long-term used in~     HPN.~      The objective of our study is to evaluate in a prospective randomised monocenter study the~     no-inferiority of PICC line to tunnelled central catheter with cuff for serious catheter~     related-complications such as infection and thrombophlebitis for patient on HPN over 1 month~     of duration. The secondary objectives are to: evaluate the number of patients with at least~     one serious complications related in 1000 days of used, the rate of minors and majors~     complications, number of catheter inserted, the satisfaction of patients and doctors.~      The study is held in CHU Nice and will be proposed to hospitalized patients who will need~     HPN. After consent, patients will be randomized to receive PICC Line (group A) of nutritional~     central catheter with cuff (group B). Echography of vessels will be held at the beginning, 3~     months and 12 months. Follow-up will be conduct at regular interval (month 0-1-3-6-9-12). The~     duration of follow-up will be of 12 months and the global duration of the study will be 36~     months. One major complication will conduct to withdrawal of the study. There will be 55~     patients in each group.~   "
131966|NCT01840020|"~     The first-pass metabolism (FPM) is a barrier to the toxicity of ethanol. Changes to the size~     and function of the stomach may alter FPM. Bariatric surgery, like the gastric bypass~     procedure, involves significant changes to the size and function of the stomach and leads to~     more rapid gastric emptying. Consequences will be faster absorption and higher peak~     concentration of ethanol after surgery than before. There are growing concerns that surgery~     for obesity in this way may cause alcohol abuse.~      In this study the investigators compare changes in FPM of ethanol following two different~     bariatric surgical procedures.~   "
131967|NCT01840007|"~     In western countries, melanoma represents a major mistake of public health by its frequency,~     lethality and the increasing of incidence. Surgery can cure melanoma diagnosed very early. In~     other cases, it exists a risk of recurrence of lymph node and visceral. At the stage of~     visceral metastases, the prognosis of melanoma is catastrophic, with a median survival of 6~     months. Indeed, the reference chemotherapy by dacarbazine induces a very limited response~     rate of 10-20%, the ipilimumab which has been authorized in the second intention, has a~     response rate of 10%, and other available treatments don't have a superior efficiency.~     Metformin is an oral antidiabetic of biguanides family which acts by inducing the activation~     of AMPK, a molecule which is inactivated in many cancers including the melanoma. In agreement~     with these data, several preclinical studies suggested that metformin has antineoplastic~     activity. In the case of melanoma, a study published recently has showed that metformin~     inhibits proliferation of melanoma cells in vitro and we confirmed for our part these results~     in our laboratory (INSERM U895).~   "
131968|NCT01839994|"~     The purpose of this study is to compare the outcomes of conventionally fractionated conformal~     radiotherapy with CF-CRT combined with either high-dose-rate brachytherapy or stereotactic~     body radiotherapy for intermediate or high-risk prostate cancer patients.~   "
131969|NCT01839981|"~     This pilot clinical trial studies 6,8-bis(benzylthio)octanoic acid in treating patients with~     locally advanced or metastatic pancreatic cancer. Drugs used in chemotherapy, such as~     6,8-bis(benzylthio)octanoic acid, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing.~   "
131970|NCT01839968|"~     The purpose of this ex-vivo study is to estimate the optimal platelet quantity necessary to~     reverse the antiplatelet effects of prasugrel.~   "
131971|NCT01839955|"~     This phase I trial studies the side effects and best dose of quinacrine dihydrochloride when~     given together with erlotinib hydrochloride and to see how well it works in treating patients~     with stage IIIB-IV non-small cell lung cancer. Erlotinib hydrochloride may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as quinacrine dihydrochloride, work in different ways to stop the growth~     of tumor cells, either by killing the cells or by stopping them from dividing. Giving~     erlotinib hydrochloride together with quinacrine dihydrochloride may kill more tumor cells~   "
131972|NCT01839942|"~     For laparoscopic ventral hernia repair, the technique to close the hernia gap is not well~     established. Mainly three techniques are currently applied:~        -  no closure at all~        -  extracorporal suturing of the gap~        -  intracorporal suturing of the gap~      All three techniques have been applied at our hospital. Patients who received laparoscopic~     hernia repair between 2006 and 2011 will be identified from the patient database and will be~     contacted by phone to inquire about the outcome and the satisfaction of the surgery.~   "
131973|NCT01839929|"~     The purpose of this study is to evaluate the efficacy of tacrolimus modified release~     formulation Advagraf® after conversion from Prograf® in stable kidney transplant patients.~   "
133017|NCT01826201|"~     The purpose of this study is to determine whether MOL4239 is effective in adult subjects with~     mild to moderate plaque psoriasis by comparing two target lesions in which each subject will~     apply MOL4239 ointment to one target lesion and placebo ointment to the contralateral target~     lesion twice a day for 28.5 consecutive days.~   "
131974|NCT01839916|"~     This pilot phase II trial studies how well giving donor T cells after donor stem cell~     transplant works in treating patients with hematologic malignancies. In a donor stem cell~     transplant, the donated stem cells may replace the patient's immune cells and help destroy~     any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T~     cells (donor lymphocyte infusion) after the transplant may help increase this effect.~   "
131975|NCT01839903|"~     Emergency Departments (EDs) are a critical component of the U.S. healthcare system, treating~     over 119 million patients each year. While EDs have historically neglected tobacco control~     efforts, several recent studies have examined the feasibility and efficacy of implementing~     tobacco cessation in the ED. Work by our research team and others, has shown that tobacco~     treatment is both feasible and effective in the ED setting.~      Effective, evidence-based interventions for treating tobacco dependence have also been~     codified in the United States Public Health Service guidelines. Even brief interventions~     delivered by physicians and other healthcare providers can produce significant increases in~     cessation across diverse clinical settings (e.g., outpatient clinics, surgery units, EDs),~     and patient groups (cardiac, respiratory, general admissions). However, in clinical practice,~     delivery of tobacco interventions is inconsistent at best, particularly in non-primary care~     settings.~      This translational study uses an existing Emergency Department Information System (EDIS), to~     facilitate the identification of smokers and to enhance the provision of smoking cessation~     intervention materials and pharmacological adjuncts for patients receiving treatment in the~     ED. The EDIS tracks the geographic and chronologic progression of patients through the ED and~     contains triage and nursing notes, lab values, radiology reports and links to images, vital~     signs, embedded printable discharge instructions, and fax links to primary care provider~     (PCP) offices.~      Following recruitment of a baseline (care-as-usual) cohort (Step 1), the investigators will~     provide training to ED physicians and staff to improve the identification and treatment of~     smokers. Following Step 1, the investigators will make adaptations to the EDIS system that~     include smoking status tracking, tobacco treatment prompts and medication information panels~     for the emergency treating physician, and links to printable discharge instructions,~     quit-smoking medication information and referral to a pro-active phone follow-up counseling~     for enrolled smokers. A second cohort of participants (Step 2) will be enrolled after~     implementation is complete. Contemporaneous with Steps 1 and 2, participant cohorts will be~     recruited at a control site (UMass Medical) to control for potential effects of historical~     trends. This study represents a comprehensive systems-based translation of empirically~     supported tobacco treatment built into a widely used patient tracking platform (MedHost)~     maximizing the probability of developing a sustainable tobacco intervention that can be~     readily disseminated.~      Specific Aims A.1. To test the incremental efficacy of a modified Emergency Department~     Information System (EDIS) MedHost, using a multiple-cohort design implemented in 2 steps.~     Two recruitment phases (baseline/care as usual and full implementation) will be used to~     assess the impact of EDIS enhancements on rates of identification and treatment of ED~     patients who smoke. The primary outcome is the difference in six-month abstinence between~     those recruited prior to program implementation (Baseline) versus those recruited when the~     program is fully implemented (Step 2). H1) Smokers enrolled during Step 2 at RIH will show~     significantly greater cessation at month 6 compared Step 1 and control site participants.~      A.2. To compare rates of smoker identification, physician intervention and follow up care for~     smoking cessation and use of quit-smoking medications among ED patients recruited before and~     after EDIS modification. H2) Compared to Step 1 and the control site, Step 2 will show~     significantly higher rates of smoker identification, physician intervention and follow-up for~     smoking, and use of quit-smoking medications.~      A.3. To investigate the effects of the EDIS enhancement on relevant behavioral and~     psychological constructs that may act as mediators of smoking behavior change (Mechanisms of~     Action), and the relationships of these potential mediators to smoking cessation (e.g.,~     perceived risk, nicotine dependence; in Measures section). H3) Participants enrolled during~     Step 2 at RIH will show greater changes in posited mediational constructs than those enrolled~     in Step 1 and at the control site.~      A.4. To examine the incremental costs of implementation of the intervention and to conduct~     analyses of marginal cost effectiveness using cost-per-smoker-quit. (This aim is not~     hypothesis driven) Exploratory Aim: A.5. To examine ED physician and other health care~     providers (HCP) attitudes regarding the utility of the EDIS system for tobacco intervention.~     The investigators will conduct interviews with ED physicians and nurses to elicit their~     perceptions of the usefulness and helpfulness of the modified EDIS, and its effects on their~     perceived self-efficacy and motivation to provide tobacco intervention. The investigators~     will also solicit direct feedback on the modified platform and user interface.~   "
131976|NCT01839890|"~     Study objective is the evaluation of safety and efficacy at 9 months of combination treatment~     of bare metal Stent plus Paclitaxel Eluting Balloon vs bare metal stent (conventional~     treatment) in patients with acute myocardial infarction with systolic time elevation of less~     than 12 hours of evolution.~   "
131977|NCT01839877|"~     Treatment of patients with colorectal cancer having liver metastases is currently based on~     systemic chemotherapy.~      Triple therapy with 5FU, oxaliplatin and irinotecan intravenously was effective in terms of~     response and secondary resectability, however it is particularly toxic.~      Hepatic intra-arterial chemotherapy (HIA) has been the subject of several studies. It has~     shown good efficacy with oxaliplatin and FUDR. However, the procedure is difficult to set up~     and reserved for experienced centers.~      The objective of this protocol is to use a triple therapy based on 5FU and oxaliplatin~     associated to irinotecan which is administered by hepatic intra-arterial route, loaded onto~     microbeads (DEBIRI). Furthermore, the procedure for chemo-embolization DEBIRI is limited to 2~     sessions, and therefore could be more easily generalized.~   "
131978|NCT01839864|"~     The study aims are to test whether the use of promotoras significantly impacts the health~     attitudes, health seeking behaviors, and patient confidence in self-managing health of rural~     Hispanic adults who have been diagnosed with metabolic syndrome. Specifically, the study is~     designed to address four areas of inquiry: 1) identification of patient attitudes involving:~     a) trust in medical providers and in the health care system, b) procedural fairness in~     treatment, c) provider and patient communication patterns, d) potential cultural bias in~     treatment, and e) healthy lifestyle behavior adoption/maintenance, 2) selected clinical~     indicators of metabolic syndrome (blood pressure, height/weight/BMI, blood glucose,~     hemoglobin A1c, and cholesterol), 3) the cultural competence of medical providers from the~     perspective of both the provider and the patient, and 4) patient self-management confidence~     scores.~   "
131979|NCT01839851|"~     The purpose of this study is to prospectively examine the relation between topical~     corticosteroid use and hair cortisol concentration, among patients with moderate persistent~     asthma or allergic rhinitis. The investigators hypothesize that patients with asthma or~     allergic rhinitis treated with topical corticosteroids (i.e. inhaled corticosteroids (ICS) or~     intranasal glucocorticoids (INGC)) have higher levels of hair cortisol after 3 months of~     treatment than during the 3 months prior to initiation of treatment.~   "
131980|NCT01839838|"~     The overall objectives of the study are to establish feasibility and acute side effects of~     accelerated partial breast irradiation therapy, along with more long-term side effects and~     clinical efficacy of treatment.~   "
131981|NCT01839825|"~     The objective of the study is to examine the efficacy and safety of QuietCare in a~     randomized, open study in elderly subjects living in assisted/ independent living facilities~     for 6 months.~   "
131982|NCT01839812|"~     Our objective was to determine whether a standard 1mg/kg intraoperative dose of dexamethasone~     results in similar drug levels for all patients and to characterize the relationship between~     these drug levels and the innate stress response following infant Cardiopulmonary Bypass~     (CPB). The investigators hypothesized that postoperative dexamethasone levels are highly~     variable, and that the infant stress response is inversely related to the amount of~     dexamethasone measured in the blood. To test this theory the investigators simultaneously~     measured blood levels of dexamethasone and cortisol at critical time points during the~     perioperative period for infants undergoing CPB for CHD surgery.~   "
131983|NCT01839799|"~     Determine the relapse-free survival of resected pancreatic cancer patients following two~     novel regimens with activity in advanced disease.~   "
131984|NCT01839786|"~     The purpose of this study is to evaluate the lung Doppler signals in patients with pulmonary~     hypertension that undergo (prospective arm) or underwent (retrospective arm) right heart~     catheterization (RHC) in order to assess whether this non-invasive tool could be used in~     pulmonary hypertension diagnosis and monitoring.~   "
131985|NCT01839773|"~     The objective of this study is to evaluate the efficacy and safety of DHP107 (Oral~     paclitaxel) in comparison to Taxol®(IV paclitaxel) in Patients With Metastatic or Recurrent~     Gastric Cancer After Failure of 1st Line Chemotherapy With Fluoropyrimidine +/- Platinum.~   "
131986|NCT01839760|"~     The objective of the study is virological assessment (e.g., proportion of prolonged viral~     shedding, median days to viral clearance, and viral load) in laboratory-confirmed adult~     influenza patients admitted to the general ward and/or to the ICU and to assess the~     correlation with the clinical manifestations and prognosis.~   "
131987|NCT01839747|"~     This research study is a Pilot study (a small preliminary study to assess the feasibility of~     a larger, more in depth study involving a new test or procedure) and is being done to~     evaluate the feasibility and accuracy of PET/MRI in the evaluation of cancer. PET/MRI is a~     FDA approved technology that is currently being studied to assess its accuracy and utility in~     the diagnosis and management of a variety of diseases and patient populations. The focus of~     this particular study will be to compare the performance of PET/MRI in its ability to detect~     and characterize cancerous tumors using positron emission topography and computed tomography~     (PET/CT) as a reference standard.~   "
131988|NCT01839734|"~     The use of lubiprostone will decrease the levels of immune activation in HIV-infected~     subjects with incomplete CD4+ T-cell recovery with antiretroviral therapy (ART).~        -  Lubiprostone will decrease levels of translocated gut microbial products in HIV-infected~          subjects with incomplete CD4+ T-cell recovery with ART.~        -  The decrease in levels of translocated gut microbial products will be associated with a~          decline in the levels of immune activation in HIV-infected subjects with incomplete CD4+~          T-cell recovery with ART.~   "
131989|NCT01839721|"~     In this double-blinded randomized clinical trial study, investigators assessed probiotic used~     to prevent or delay radiation induced grade moderate to severe diarrhea with patient treated~     for pelvic cancer.~   "
131990|NCT01839708|"~     Mothers in Motion will draw on the successes of the pilot intervention of the same name and~     will promote healthy lifestyle behavior changes (eating more fruits and vegetables,~     increasing physical activity, dealing with stress) in low-income WIC mothers of young~     children. The intervention group's weight change (difference between the initial enrollment~     and 3 months post intervention) will differ from the control group's weight change by an~     average of at least 2.8 pounds.~   "
131991|NCT01839695|"~     The Valiant Mona LSA thoracic stent graft system is for the endovascular repair of aneurysms~     of the descending thoracic aorta (DTA) in patients who require coverage of the left~     subclavian artery (LSA).The study is intended to assess safety and performance of the device~     acutely and at 30 days.~   "
131992|NCT01839682|"~     This post-market surveillance research project consists of data collection at specified time~     points using standard questionnaire instruments to compare pain level, mobility and function~     pre and post procedure using the D-Fine StabiliT® Vertebral Augmentation System and StabiliT®~     Bone Cement, an FDA approved product used in the standard treatment of vertebral compression~     fractures.~   "
131993|NCT01839669|"~     Pes planovalgus, also called flat foot, is a common foot deformity characterized by a~     flattening of the foot's longitudinal arch and is accompanied by a dysfunction of the~     posterior tibial tendon (posterior tibial tendon dysfunction or PTTD). Early stages of~     this pathology are thought to be treated with non-surgical therapy options like foot orthoses~     (relief of tendon stress by mechanical unloading of the arch), strengthening exercises or~     basic physiotherapeutic measures. Recent literature clearly states the urgent need for high~     quality studies to evaluate the proposed non-surgical treatments (Bowring 2009, 2010). There~     is only one high quality study available that shows benefits of orthoses therapy and exercise~     (Kulig 2009). No study to date evaluated functional changes pre-post in dynamic movement~     pattern like gait or stair climbing. The widespread use of several non-surgical treatment~     strategies lead to extensive financial expenses of the health care system. An optimized~     therapeutic strategy could eventually lead to more efficient health care investments. The~     presented proposal addresses this latest knowledge and aims to analyse non-surgical treatment~     strategies to Cure Pes Planovalgus associated Complaints (CurePPaC) in the CurePPaC Study.~   "
131994|NCT01839656|"~     The primary objective is to examine the clinical efficacy of multiple doses of nusinersen~     (ISIS 396443) administered intrathecally to participants with Infantile-Onset Spinal Muscular~     Atrophy (SMA). The secondary objectives are to examine the safety and tolerability of~     multiple doses of nusinersen administered intrathecally to participants with infantile-onset~     SMA and to examine the cerebral spinal fluid (CSF) and plasma Pharmacokinetics (PK) of~     multiple doses of nusinersen administered intrathecally to participants with infantile-onset~     SMA.~   "
131995|NCT01839643|"~     In this study, the investigators propose to assess if a non-hormonal agent is absorbed by a~     local route (vaginal) and observe the effect on follicular development. This study will~     include 3 menstrual cycles, beginning with one menstrual control cycle, following by one~     menstrual cycle with meloxicam ring administration and finishing with another control~     menstrual cycle.~      Meloxicam will be administered via a vaginal ring in two doses of 2.4 g and 3.0 g/ ring~     during one menstrual cycle. Safety study of absorption will be assessed. Also the~     investigators will study the effect on follicular development and if it maintains ovarian~     cyclicity, as well as shown in recent study with oral administration.~   "
131996|NCT01839630|"~     This study is to obtain the characteristics and treatment pattern of the unresectable HCC~     patients who are candidates for systemic therapy and in whom a decision to treat with~     sorafenib from early stage of TACE treatment course (concomitantly use no later than the 3rd~     TACE procedure) has been made under real-life practice conditions.this study will also~     conclude the safety and effectiveness of combination in uHCC patients.~   "
131997|NCT01839617|"~     The aim of this study is to find which is the best nutritional strategy in cancer patients~     undergoing abdominal surgery regarding postoperative complications.~   "
131998|NCT01839604|"~     This is a phase I/Ib open-label, multicentre study to assess the safety, tolerability,~     pharmacokinetics and preliminary anti-tumour activity of AZD9150 in patients with~     advanced/metastatic hepatocellular carcinoma.~   "
131999|NCT01839591|"~     In severe bronchial asthma the mechanism of inflammation and bronchospasm is complex and~     still not clarified. The smooth muscle cells play an important role from the mechanical point~     of view, as a culmination of neurogenic stimuli and inflammatory cytokines that determine as~     final effect the bronchospasm and over time a hypertrophy of the muscular coat. There are~     some other hypothesis that the smooth muscle cells may play a role as central regulator of~     chemical mediators that cause bronchospasm and inflammation, although there are currently no~     firm conclusions 2 According to other studies3,the nerve receptors TRANSIENT RECEPTOR~     POTENTIAL VANILLOID TYPE 1 have a great importance in the complex mechanism of airway~     inflammation too. (There are at least 4)~      These receptors would intervene according to the following mechanism:~        1. Irritants on the bronchial mucosa stimulate the TRANSIENT RECEPTOR POTENTIAL VANILLOID~          TYPE 1 present on afferent endings of sensory fibers, unmyelinated C (chemiosensitive~          neurons)~        2. On the same afferent axon acting factors with the activation effect (lowering the~          activation threshold, increase the expression, promote the translocation of TRPV1~          receptor on the membrane). Among these factors the neurotrophins of which the most~          important NERVE GROWTH FACTOR (NGF)~        3. The activation of TRPV1 (through release of Ca2 + +) determines two efferent responses:~             1. CENTRALLY-MEDIATED~             2. LOCAL AXON Reflex~      Investigators hypothesized that BT may have a strong influence on the destruction of nerve~     receptors TRPV1 and unmyelinated nerve fibers located in the mucosa going to stop reflections~     both central and local authorities responsible for the activation of bronchospasm. In support~     of this hypothesis, there are some anatomical studies4, which show that these receptors are~     more numerous at the level of main bronchi which are the main target of BT. Please note in~     this context that it is already known that in thermoablations commonly used in cardiology it~     is used a radio frequency with development of heat controlled to 65 °, as in the BT, able to~     interrupt the circuit nervous responsible for the activation of the circuit causing the~     abnormal 'arrhythmia.~   "
132023|NCT01839279|"~     This is a single-center, partial-blind, randomized, placebo-controlled, parallel design study~     with a nested crossover comparison to define the ECG effects of tizanidine compared to~     placebo and the positive control, moxifloxacin, in healthy men and women. The study will be~     conducted in a Phase 1 unit with sufficient facilities to house subjects as required by the~     protocol.~   "
132084|NCT01838473|"~     In an open label, randomized, two-way cross-over study, 32 male healthy regular snus users~     will be given repeated doses of four different types of portion snus: General, Catch,~     Catch Mini and Catch Dry Mini. Each portion of used snus will be collected and frozen~     (-20 oC) pending analysis of lead (Pb), cadmium (Cd), nicotine and tobacco specific~     nitrosamines (TSNAs). Unused snus is collected and deep frozen for analysis and calculation~     of extracted dose. Calculations of extracted amount of lead, cadmium, nicotine and tobacco~     specific nitrosamines (TSNAs) respectively, will be done for each type of snus.~   "
132000|NCT01839578|"~     Sepsis is responsible for 50% of all acute kidney injury (AKI) in intensive care units~     (ICUs), contributing greatly to multiple organ dysfunction syndrome (MODS). Special types of~     continuous renal replacement therapies (CRRT) have been proposed as adjuvant therapies for~     septic shock due to their ability to remove middle molecular weight molecules such as~     inflammatory mediators involved in MODS pathophysiology. These therapies are called~     extracorporeal  blood purification  therapies.~      When CRRT is used, an anticoagulation is required to prevent clotting of the extracorporeal~     circuit, possibly causing bleeding in selected patients. Many anticoagulation strategies have~     been proposed and the most commonly used in 2013 is still unfractionated heparin. Regional~     citrate anticoagulation (RCA) is an interesting alternative as it dramatically decreases the~     bleeding risk.~      The investigators hypothesize that the use of citrate with Super High Flux Continuous~     Veno-Venus Hemodialysis (SHF-CVVHD) would be highly beneficial over time by preserving the~     filter effectiveness via limiting protein adhesion (which subsequently reduces filter pore~     sizes (protein cake)), as compared to heparin. Consequently, higher clearances of the~     inflammatory mediators could be maintained over time with citrate as compared to heparin~     anticoagulation. In other words, for the same duration of filter use, middle molecular weight~     molecules and cytokines clearances would be greater with citrate as compared to heparin. To~     test this hypothesis, the investigators will perform a clinical randomized controlled trial~     which aim would be to compare middle molecular weight molecules and cytokines clearances in~     SHF-CVVHD using RCA versus systemic heparin anticoagulation in septic patients with AKI.~   "
132001|NCT01839565|"~     The absence of methodologically, prospectively and retrospectively collected information on~     the use of the Quadrilateral Surface Plate (QSP) in the given indication requires a~     multicenter approach. Using a registry to get more information about the effectiveness and~     possible benefits or complications during the surgery and during the post-operative treatment~     is adequate and necessary to get new insights to the use of the Quadrilateral Surface Plate.~   "
132002|NCT01839552|"~     Lazanda is a prescription nasal spray medicine that contains the medicine fentanyl. It is~     used to manage breakthrough pain in adults with cancer who are already routinely taking other~     opioid pain medicines around-the-clock for cancer pain. Lazanda is started only after taking~     other opioid pain medicines and the patient's body has become used to them (opioid tolerant).~      The purpose of this study is to assess the ability of Lazanda to control pain during an~     episode of breakthrough pain in cancer patients.~   "
132003|NCT01839539|"~     The purpose of this study is to evaluate the efficacy of dendritic and cytokine-induced~     killer cells (DC-CIK) for colorectal cancer (CRC).~   "
132004|NCT01839526|"~     No investigational drug will be administered in this study for the treatment of Fabry~     disease.~      This will be a multicenter, multinational, non-treatment, cross-sectional study of young male~     patients with Fabry disease who have not yet initiated interventional treatment for this~     disease. The study will consist of a screening visit(s), a clinical investigation visit(s),~     and a follow-up phone contact.~      The objectives of the study are:~        -  To document renal function and other Fabry disease manifestations across age in~          treatment-naïve, young male patients with Fabry disease.~        -  To provide a reference group for comparison with interventional clinical trials of Fabry~          disease.~      The duration of each patient's participation in the study, inclusive of the screening visit~     and follow-up phone contact, will be approximately 12 weeks.~   "
132005|NCT01839513|"~     The aim of this study is to evaluate the performance of Analgesia/Nociception Index for the~     prediction of hemodynamic reactivity in adult patients undergoing ear-nose-throat or lower~     limb orthopedic surgery on desflurane/remifentanil general anesthesia.~   "
132006|NCT01839500|"~     This prospective, multi-center, non-interventional study will evaluate the efficacy and~     safety of trastuzumab in routine clinical practice in Chinese participants with gastric or~     gastro-oesophageal cancer. The study will be conducted in 5 cohorts and eligible participants~     will be enrolled and assigned to the various cohorts according to human epidermal growth~     factor receptor 2 (HER2) status, disease stage and treatment with trastuzumab according to~     physician's decision. Treatment patterns and clinical outcomes in participants with gastric~     cancer in China will be evaluated. The total study duration is 60 months.~   "
132007|NCT01839487|"~     To compare the treatment effect of PEGPH20 combined with nab-paclitaxel and gemcitabine (PAG)~     to nab-paclitaxel and gemcitabine (AG) in subjects with Stage IV pancreatic cancer.~      The Phase 2 will study safety and treatment effect in 237 subjects (2:1 randomization,~     PAG:AG), preceded by two run-in phases (the first to assess safety and tolerability and a~     second to assess a new formulation of PEGHP20), 16 subjects total (randomized 3:1).~   "
132008|NCT01839474|"~     The purpose of this study is to determine if the use of a continuous positive airway pressure~     (CPAP) machine (a device that blows air into the lungs) decreases the chance of a child dying~     from difficulty breathing.~   "
132009|NCT01839461|"~     The purpose of this research study is to identify factors and genes (the DNA material that~     determines the makeup of the human body) that may be associated with how children respond to~     pain medication. Morphine is a pain medication commonly prescribed after this surgery during~     the hospital stay. The investigators want to study factors that may be associated with pain~     sensitivity, morphine requirement after surgery and side-effects from morphine. The~     investigators expect that the information obtained in this research study will help to~     develop effective, safer, and tailored treatment options in the future.~   "
132010|NCT01839448|"~     The main objective of the study is to estimate and compare the percentage of patients with~     abnormal glucose metabolism at 4-12 weeks postpartum between two groups: patients diagnosed~     with gestational diabetes before or after 24 weeks of pregnancy. Abnormal glucose metabolism~     is defined as type 2 diabetes, glucose intolerance or impaired fasting glucose.~   "
132011|NCT01839435|"~     The aim of our monocentric prospective in intention-to-treat study is to evaluate the~     feasibility of outpatient appendectomy for non complicated acute appendicitis.~   "
132012|NCT01839422|"~     This research attempts to better understand the altered and preserved memory mechanisms in~     Alzheimer disease, particularly to better apprehend learning implicit memory processes, and~     give a scientific support to non-pharmalogical interventions. At the present time, it is~     possible to delay the emergence of the symptoms related to this disease, eventually to~     decrease it, but not to cure it. Yet, care these patients became a crucial question and the~     solutions proposed to healthy aging people are not appropriate for Alzheimer patients who~     present specific disorders. The improvement of the quality of life of the institutionalized~     patients lies on a better comprehension of their disorders but also of their preserved~     abilities. The literature testifies of a great heterogeneity in the clinical expression of~     this disease, however we noticed two constants with regard to the capabilities generally~     announced as being preserved, on one hand, the implicit memory, and on the other hand the~     artistic aptitudes, and more particularly musical capabilities.~      Patients with Alzheimer disease present a particularly severe and early deterioration of~     episodic memory. Thus, at the beginning of the disease the explicit acquisition of new~     knowledge becomes increasingly difficult. However, some clinical observations, such as new~     learning of unknown songs, even with patients at a severe stage of the illness, seem to~     support the assumption of a preservation of some implicit learning abilities. Indeed, several~     studies already showed preserved implicit memory capabilities among patients with Alzheimer~     disease, mostly at the beginning stage of the illness: preserved effects of perceptual~     priming, procedural learning. Thus, we are mainly interested by the effects of exposure and~     the rising of a feeling of familiarity, both showing preserved implicit learning abilities,~     for moderate to severe Alzheimer patients. However, no study was carried out to date using~     the neuroimaging techniques, among Alzheimer patients at a moderated to severe stage of~     illness, with the main objective to identify the cerebral substrates implied in the learning~     of new knowledge.~      Indeed, several studies already showed preserved implicit memory capabilities among patients~     with Alzheimer disease, mostly were performed at the beginning stage of the illness and none~     of them have studied theses learning abilities for moderate to severe Alzheimer patients.~      The objective of this work is to specify, in severe form of Alzheimer disease, the cognitive~     mechanisms allowing the memorizing (feeling of familiarity) of new information and thus to~     highlight neural networks underlying this learning process (recently learned stimuli vs old~     stimuli). The goal is to propose a positive image of the Alzheimer patients, in understanding~     which cognitive mechanisms and cerebral areas allow these learning capabilities.~      20 patients Alzheimer at a moderate to severe stage, 20 patients at a mild to moderate stage~     of the illness, and 20 healthy aging participants, are selected after a neurological~     interview and a neuropsychological evaluation. The whole of the included participants take~     part of the experimental protocol organized in two phases: - the phase of familiarization and~     the phase of test. The phase of familiarization consists of the repeated exposure (daily~     session before the MRI acquisition) of new songs and new painting until obtaining a high~     feeling of familiarity for each item. The phase of test is carried out in the 3T MRI camera,~     it comprises an anatomical (T1, T2 MRI) and a functional acquisitions. The functional~     acquisition corresponds to a passive listening and seeing tasks of musical and pictorial~     stimuli. Finally, all participants realize a debriefing phase that allows obtaining a~     feedback on the familiarity of stimuli presented during the functional acquisition.~   "
132013|NCT01839409|"~     The purpose of this study is to study the relationship between the vestibular system and~     chronobiology~   "
132014|NCT01839396|"~     The purpose of this study is to evaluate the safety and effectiveness of Boston Scientific's~     Vercise Deep Brain Stimulation (DBS) system in the treatment of patients with with advanced,~     levodopa-responsive bilateral Parkinson's disease (PD) which is not adequately controlled~     with medication.~   "
132015|NCT01839383|"~     The investigators enrolled 90 patients on maintenance hemodialysis with dialytic vintage ≥12~     months, iPTH 150-300pg/ml and serum calcium<2.5mmol/L. Patients were randomized to three~     groups with different dialysate calcium concentration , 1.25 mmol/L(DCa1.25),~     1.5mmol/L(DCa1.5) and 1.75 mmol/L(DCa1.75) for 24 months respectively. Hemodialysis was~     performed for 4 hours three times weekly. Serum total calcium(tCa), ionized~     calcium(iCa),intact parathyroid hormone(iPTH)and phosphorus (P) levels were recorded before~     and after the study and single dialysis session in every patient. iCa and P levels were~     measured in spent dialysate.Bone density, bone-specific alkaline phosphatase(BAP),~     osteoprotegerin(OPG)、β-crosslaps、total Procollagen Type I Intact Propeptide (P1NP）and~     vascular calcification were measured in every patient periodically. vascular calcification~     including aortic arch calcification, abdominal aorta calcification and coronary artery~     calcification were measured by chest radiography, lateral lumbar radiographs and coronary~     artery computer tomography (CT) respectively. The primary endpoints included death,~     cardio-cerebral vascular disease(defined as heart failure, myocardial infarction and stroke),~     newly nontraumatic bone fracture, secondary parathyroidism uncontrolled by medicine and~     valvular or vascular calcification. The secondary endpoint were admission or emergency~     observation.~   "
132016|NCT01839370|"~     In this study, a closed-loop Adaptive Insulin Meal Supervisor system (AIMS) utilizing~     continuous glucose monitoring (CGM), a subcutaneous insulin pump and standard pramlintide~     therapy will be applied in individuals with type 1 diabetes. Pramlintide, a drug well~     recognized to help control hyperglycemia with meals, will be evaluated in both closed loop~     and open loop control. It is expected that the closed loop control condition with pramlintide~     will improve glycemia, thus combining better control with enhanced safety. In a recent pilot~     study, the investigators started testing this concept and collected data showing that in~     order to be successful such strategy must have a controller equipped with the ability to~     optimize the configuration and timing of meal boluses with concomitant administration of~     pramlintide. Our preliminary data and review of previously unavailable individual data from a~     German study indicate a large individual variability in the timing of the appearance of meal~     insulin needs. Thus, for both adequate safety and efficacy of meal insulin on pramlintide,~     the investigators have developed a new closed-loop controller that accounts for the~     variability in the individual responses to a meal and meal delays, the Adaptive Insulin Meal~     Supervisor system (AIMS). In this study, the performance of a combination between the AIMS~     system and a standard pramlintide treatment will be tested versus the standard pramlintide~     treatment alone.~   "
132017|NCT01839357|"~     A study for subjects with atrial fibrillation (AF) or atrial flutter who are diagnosed with~     left atrial (LA) or left atrial appendage (LAA) thrombus. The study will assign subjects to~     rivaroxaban for treatment of thrombi. The study will measure thrombus outcomes based on echo~     image and common clinical outcomes such as bleeding and stroke or thromboembolism.~   "
132018|NCT01839344|"~     The purpose of this study is to measure the effect of quercetin on glucose tolerance and~     postprandial endothelial function in comparison to placebo and Acarbose in participants with~     Type 2 Diabetes.~      Primary Hypothesis: We hypothesize that administration of quercetin (2g oral) prior to a 100g~     maltose tolerance test (MTT) will result in a decrease in postprandial blood glucose at 60~     minutes compared to placebo. Acarbose (100mg oral), a pharmaceutical alpha-glucosidase~     inhibitor, will serve as a positive control.~      Secondary Hypothesis: We hypothesize that administration of quercetin (2g oral) will reduce~     the Area Under the Glucose Curve (AUC) for the 2 hours following a 100g MTT compared to~     placebo. AUC is hypothesized to be comparable between quercetin and Acarbose.~      Tertiary hypothesis: We hypothesize that administration of quercetin (2g oral) prior to a~     100g MTT will result in a smaller reduction in flow mediated dilation (FMD) measured as an~     increase in Reactive Hyperemia Index (RHI) at 90 minutes compared to placebo.~   "
132019|NCT01839331|"~     This study will evaluate the efficacy of two doses of Intra-Articular Injection of Ampion™ in~     Adults with pain due to osteoarthritis of the knee.~   "
132020|NCT01839318|"~     The purpose of this study was to compare three CE-marked daily disposable contact lenses for~     tear film stability as measured by pre-lens non-invasive keratograph break up time (PL~     NIK-BUT). Secondarily, contact lens surface wettability was assessed.~   "
132021|NCT01839305|"~     Fibromyalgia Syndrome (FS) is one condition that most affects functional performance,~     especially in women, due to alterations in the entire musculoskeletal system. Given that,~     Physical Therapy (PT) studies the human movement and its dysfunctions, and that FS, because~     of its complex chronic characteristic, impairs the affected individual's activities causing~     movement disorders, a PT professional must be part of the multidisciplinary team involved in~     the FS treatment. Nonetheless, as explained in the present proposal, several aspects still~     need clarification related to the PT role in this syndrome. Particularly, studies that~     analyze the biomechanical, sensorial and cardiorespiratory adaptations in individuals who~     undergo PT intervention still lack; those studies would contribute with scientific evidence~     to the clinical practice. According to recent systematic reviews, one of the most used~     therapies with positive effects on FS subjects is the hydrotherapy, which combines exercises~     and the water relaxing effects. Other alternative treatments have also been searched, in an~     attempt to decrease the painful picture presented, as the FS etiology and pathophysiology are~     not well known. The aim of this study is to evaluate the efficacy of different physical~     therapy resources in the FS, in two subprojects. The first will verify if hydrotherapy is~     effective in modifying movement variables (scapular kinematics and electromyography) and~     autonomic modulation. Other variables, such as pain level and quality of life in women with~     FS, will also be analyzed. The second study will evaluate the efficacy of the Shiatsu massage~     on pain, sleep quality, balance and quality of life of subjects with FS.~   "
132022|NCT01839292|"~     Covered self-expandable metallic stents (SEMS) have been used to prevent tumor ingrowth, a~     common complication of uncovered SEMSs. However, they have revealed a high incidence of stent~     migration in patients with unresectable malignant gastric outlet obstruction (GOO). A~     conformable covered SEMS was introduced to overcome both stent migration and tumor ingrowth.~     The aims of this study were to evaluate the clinical outcomes of newly designed conformable~     covered and uncovered SEMS for palliation of malignant GOO.~   "
132085|NCT01838460|"~     To compare each subject's AUCinf, after administration of one single dose of 6 mg of~     Nicorette sublingual nicotine tablets ( three 2mg tablets) to that of one single 1 g dose of~     SS containing 16 mg nicotine.~   "
132024|NCT01839266|"~     Acute pulmonary embolism (PE) is an important cause of in-hospital mortality and may be~     rapidly fatal if not diagnosed and treated. Despite recent advances in diagnostic and~     therapeutic modalities, it is still one of the important causes of hospital mortality.~     Previous several reports have described the variable outcome of patients with PE with~     reported mortality rate ranging from 8.1% (stable patients) to 25% (with cardiogenic shock)~     and 65% (post cardiopulmonary resuscitation). Nevertheless, there are no published studies~     from Korean hospitals that assessed the outcome of acute PE treated in the hospital with IV~     unfractionated heparin. We conducted this study to determine the outcome, risk factors,~     clinical characteristics and demographics of patients with acute PE and to identify possible~     demographic and clinical factors associated with prognosis.~   "
132025|NCT01839253|"~     For those who receive hypotensive anesthesia in orthognathic surgeries, the investigators~     premedicate with anti-hypertensive agent so that it decreases the occurence of tachycardia~     and the rebound hypertension due to hypotensive anesthesia, enabling us to compare~     hemodynamic stability and reduction of anesthetic agents during the operation.~   "
132026|NCT01839240|"~     This phase I trial studies the side effects and best dose of azacitidine when given together~     with cytarabine and mitoxantrone hydrochloride in treating patients with high-risk acute~     myeloid leukemia. Drugs used in chemotherapy, such as azacitidine, cytarabine, and~     mitoxantrone hydrochloride, work in different ways to stop the growth of cancer cells, either~     by killing the cells or by stopping them from dividing. Azacitidine may also help cytarabine~     and mitoxantrone hydrochloride work better by making the cancer cells more sensitive to the~     drugs~   "
132027|NCT01839227|"~     Post operative cognitive dysfunction (POCD) is a well-recognized complication of patients~     undergoing cardiac surgery. Previous studies reported near-infrared spectroscopy provides~     information on the occurrence of cerebral desaturation resulted in POCD. But evidence of POCD~     after general surgery has been lacking. Especially, the prone position is used primarily for~     surgical access to the posterior spine, if there is any significant lowering of the legs or~     tilt of the entire table, venous returns may be decrease or augmented accordingly. The~     purpose of this study was to examine the relationship between POCD and intra-operative~     cerebral oxygen saturation after spine surgery in elderly patients.~   "
132028|NCT01839214|"~     This study will examine the safety and efficacy in subjects with mild to moderate ulcerative~     colitis, as measured by Modified Mayo Score, Modified Baron Score, IBDQ, calprotectin and~     other assessments.~   "
132029|NCT01839201|"~     Hypothesis: By employing suggestions before the induction of narcosis dreams may be evoked~     and their content may be directed.~      The main goal of suggestive techniques in the perioperative phase is to turn the content of~     dreams toward a favourable direction that is considered a pleasant event by the patient. So~     far little attention has been paid to the administration of perioperative psychological~     methods that may meet these requirements.~      Along these lines, in the present study we intended to assess whether dream recalls can be~     influenced by two different psychological methods administered in the preoperative setting~   "
132030|NCT01839188|"~     To evaluate the immune response and the safety of a primary series schedule that includes~     V419 (PR5I) at 2 and 6 months of age and Pediacel at 4 months of age~      Primary objectives~        -  To demonstrate that the mixed schedule induces acceptable responses for Hepatitis B one~          month after completion of the mixed schedule~        -  To demonstrate that the mixed schedule induces acceptable responses for Hib one month~          after completion of the mixed schedule~      Secondary objectives~        -  To describe the antibody response to all PR5I antigens one month after completion of the~          mixed schedule~        -  To describe the antibody response to meningococcal serogroup C (MenC) conjugate vaccine~          one month after the second dose of MenC vaccine~        -  To describe the safety profile after each dose of study vaccines administered~   "
132031|NCT01839175|"~     Primary Series Primary objectives~        -  To demonstrate that the concomitant administration of the hexavalent vaccine with a~          meningococcal serogroup C conjugate vaccine is non inferior to the administration of the~          hexavalent vaccine without a MenC vaccine concomitantly in term of seroprotection rate~          for hepatitis B one month after the third dose of the hexavalent vaccine~        -  To demonstrate that the concomitant administration of a MenC vaccine with the hexavalent~          vaccine induces an acceptable response for MenC in term of seroprotection rate (SPR) one~          month after the second dose of MenC~      Booster Primary objectives~      - To describe the immunogenicity of a booster dose of the hexavalent vaccine and of a~     meningococcal group ACWY conjugate (MenACWY) vaccine either co-administered at 12 months of~     age or given separately.~   "
132032|NCT01839162|"~     During percutaneous coronary interventions standard operator radio-protection is generally~     ensured using a lead apron, a thyroid lead collar, low leaded flaps, an upper mobile leaded~     glass suspended from the ceiling and leaded glasses. Previous studies showed that adding a~     bismuth-barium radiation shield drape on the patient right arm or using a pelvic lead shield~     on the patient, the radiation dose adsorbed by operators was significantly reduced even if~     was higher compared to transfemoral approach. No studies evaluated the effect of both~     adjunctive shields placed in the same patient.~      Aim of our randomized study is to evaluate if the combination of a shield drape on the~     patient right arm and a pelvic lead shield during transradial percutaneous coronary~     procedures may reduce the radiation dose adsorbed by operators compared to the use of only~     one shield or none.~      All patients who underwent to percutaneous coronary diagnostic or interventional procedures~     will be enrolled in this randomized study. Eligible patients will be randomized (using a~     computer generated randomization sequence) in 4 groups:~        1. use of a pelvic shield drape~        2. use of a shield drape on the patient right arm~        3. use of a pelvic shield drape and a shield drape on the patient right arm~        4. Any adjunctive shield drape (only standard radio-protection) For each group a further~          internal randomization will be performed in order to compare the right or left radial~          transradial approach.~      Each operator will be equipped with dedicated dosimeters placed at left wrist and at thorax~     level outside the lead apron. Since December 2013 the operators are equipped with a further~     dosimeter at head level.~      Primary end-point of the study is the radiation dose adsorbed at wrist and thorax by~     operators and detected by the electronic dosimeters.~      Secondary end-point are:~        1. Radiation dose adsorbed by operators according to the radial access (right versus left)~        2. Radiation dose adsorbed by the patients~        3. Radiation dose adsorbed at head level.~   "
132033|NCT01839149|"~     This study evaluates the use of oxytocin, given as a nasal spray, for treatment of high~     frequency episodic migraine and chronic migraine.~   "
132080|NCT01838525|"~     To assess the potential value of alpha-1-acid glycoprotein (AGP) for early diagnosis and~     prognosis of patients with sepsis, and then compared with C-reactive protein (CRP),~     procalcitonin (PCT), white blood cell (WBC) counts, Acute Physiology and Chronic Health~     Evaluation (APACHE) II score and Sequential Organ Failure Assessment (SOFA) score. 164~     patients were enrolled in the study, including 25 cases with systemic inflammatory response~     syndrome (SIRS) and 139 cases with different levels of sepsis (46 moderate sepsis, 52 severe~     sepsis and 41 septic shock ). Serum levels of Alpha-1-acid Glycoprotein (AGP), C-reactive~     protein (CRP), and procalcitonin (PCT), and white blood cell (WBC) counts were measured on~     the day of admission to intensive care unit (ICU).~   "
132034|NCT01839136|"~     Background: The cost for the treatment of infertility are limiting for the health care~     access, particularly if we consider that the success rate per cycle is approximately 35%.~     Alternative regimens for controlled ovarian stimulation (COS)have been described in the~     medical literature, that lead to a lower cost, fewer injections and less risk of adverse~     events, particularly ovarian hyperstimulation syndrome. Furthermore, some services report~     excellent results with less manipulation as possible, which reduces the cost of laboratory of~     human and ethically be considered less complicated once fertilization occurs in the uterus~     and not in vitro.~      Objectives: The main objective is to compare the reproductive outcomes between intrauterine~     transfer of gametes (TG) and embryos (TE), the secondary objective is to estimate the average~     number of eggs that are raised when using an EOC reduced cost.~      Methods: This study will be conducted in the area of Human Reproduction, Department of~     Gynecology and Obstetrics Hospital of the FMRP-USP. We will conduct an open controlled study~     with random allocation of the participants in a 1:1 ratio, and we plan to include 100~     participants. All participants will undergo an EOC reduced cost. We will compare the chance~     of the treatment (TE or TG) result in a live birth and clinical pregnancy per woman allocated~     and to estimate the number of oocytes retrieved considering all participants.~   "
132035|NCT01839123|"~     The purpose of the study is to evaluate residual limb circulation and skin health associated~     with the use of a prosthetic vacuum socket. A conventional non-vacuum prosthetic socket will~     be compared to a vacuum prosthetic socket.~   "
132036|NCT01839110|"~     This study is looking to see if giving ranolazine to subjects on stable pulmonary~     hypertension specific therapies but with right ventricular dysfunction (RVEF <45%) would~     improve their outcome. This study is accompanied by a baseline comparison of the metabolic~     profiling/microRNA/iPS cells of subjects with and without right ventricular dysfunction.~   "
132037|NCT01839097|"~     The primary objective of this study is to determine the Maximum Tolerated Dose (MTD) for~     belinostat when combined with CHOP regimen and establish the recommended belinostat dose for~     the Phase 3 study.~   "
132038|NCT01839084|"~     Purpose of this study is to determine whether Xenon - as compared to Isoflurane - shows a~     nephroprotection after partial nephrectomy.~   "
132039|NCT01839071|"~     The purpose of this study is to investigate if patients with coronary heart disease have~     higher risk to develop diabetes mellitus among the following two years.~      The examination of biomarkers taken from blood and fat issue shall provide which factors~     could be responsible for development of diabetes mellitus.~   "
132040|NCT01839058|"~     Non-cardiac chest pain (NCCP) is a common disorder whose pathophysiology is poorly~     understood. Some evidence suggests it may be related to sustained esophageal contractions~     (SECs) of longitudinal smooth muscle. The investigators have previously shown that acid is a~     trigger for SECs and results in shortening of the esophagus. In this study, the investigators~     plan to prospectively evaluate esophageal shortening responses to acid in a group of patients~     with NCCP compared to controls. The investigators will use high resolution esophageal~     manometry coupled with acid infusion to evaluate shortening. The investigators hypothesize~     that at least a subset of patients with NCCP will have an exaggerated esophageal shortening~     response to acid which correlates with symptom production. If our hypothesis proves true,~     this may lead to a future therapeutic target in the treatment of these patients.~   "
132041|NCT01839045|"~     The major purpose of this study is to evaluate a laboratory developed test that measures~     multiple breast cancer-specific biomarker proteins in your blood samples. The biomarker~     results along with your personal medical profile will be evaluated to determine your risk for~     the presence of a malignancy in the breast as compared to your breast evaluation assessment~     conducted by your physician.~   "
132042|NCT01839032|"~     Patients (pts) with stage IIIA/IIIB NSCLC received NVBiv 25 mg/m² + CDDP 80 mg/m² on D1 and~     NVBo 60 mg/m² on D8 every 3 weeks (q3w) for 2 cycles as induction. Pts with response or non~     change received NVBo 20 mg fixed dose on D1 D3 D5 + CDDP 80 mg/m² on D1 q3w for 2 more cycles~     during RT(66 Gy/6.5 w).~   "
132043|NCT01839019|"~     The purpose of the study is to evaluate the safety and tolerability of escalating single~     doses of ODM-102 in healthy volunteers~   "
132044|NCT01839006|"~     The purpose of this study is to assess the clinical significance of supranormal differential~     renal function (DRF) in the recovery of unilateral hydronephrosis (HN) after surgery,~     pediatric patients who underwent pyeloplasty for ureteropelvic junction obstruction (UPJO)~     who showed supranormal DRF (> 55%) in the DTPA renography will be analyzed.~   "
132045|NCT01838993|"~     We investigate the potential benefits of ultrasound-driven lidocaine inhalation immediately~     before induction.~   "
132046|NCT01838980|"~     Motus GI is developing a single-use device that attaches to a standard colonoscope, thereby~     integrating colon cleansing, screening and treatment into one procedure. The device creates~     turbulence within the colon using water jets. The colon's fecal fluids are evacuated by the~     system.~   "
132047|NCT01838967|"~     The investigators investigate the potential pharmacokinetic drug-drug interaction between~     Cilnidipine 10 mg and Valsartan 160 mg in healthy male volunteers who receive Cilnidipine 10~     mg alone, Valsartan 160 mg , and both together in a 3 period repeatedly.~   "
132048|NCT01838954|"~     Due to constant strain the joints of the hands are frequently affected by osteoarthritis~     (OA).~      Short-wave diathermy (SWD) is a form of electromagnetic therapy, which causes movement of~     ions, distortion of molecules, and creation of eddy currents and as a result heat is produced~     in deep tissue. Its claimed mechanism of action includes inducing an anti-inflammatory~     response, reducing joint stiffness, stimulating connective tissue repair, and reducing muscle~     spasm and pain.~      Since the available studies were performed to study the large weight-bearing joints only,~     there is a lack in scientific evidence for the efficacy of SWD in hand OA.~      The aim of this randomized, double blind, placebo-controlled study is to evaluate the effect~     of SWD on:~      joint function in patients with hand OA. joint pain in patients with hand OA. grip strength~     in patients with hand OA. quality of live in patients with hand OA.~   "
132081|NCT01838512|"~     This is a non-interventional observational study aimed at understanding the real world~     effectiveness of novel agents used in treating multiple myeloma and their impact on~     patient-reported outcomes. This study will collect information that is already in medical~     records regarding treatment and diagnostic procedures. Patients are asked to complete~     questionnaires for patient-reported outcome measures.~   "
132049|NCT01838941|"~     The PBD are a rare group of inherited disorders due to the failure to form functional~     cellular peroxisomes. Most patients have progressive hearing and visual loss, leading to~     deafness and blindness, as well as neurological deterioration. There are no therapies for~     this disorder. A misfolded protein with residual function, PEX1-Gly843Asp, represents one~     third of all mutant alleles. Using patient cell lines with this mutation, we reported the~     recovery of peroxisome functions by treatment with Betaine, acting as a nonspecific chemical~     chaperone for the misfolded PEX1 protein. Betaine, or trimethylglycine, is a Health Canada~     and FDA approved orphan drug for the treatment of homocystinuria and is used by us safely and~     regularly in genetic medicine. We will perform a 6 month pilot study with 12 patients to test~     the hypothesis that Betaine, at recommended doses, can recover peroxisome biochemical~     functions in blood.~   "
132050|NCT01838928|"~     Background: The use of ultrasound in regional anesthesia enables a reduction in the local~     anesthetic volume. The present study aimed to determine the minimum effective concentration~     (EC50 and EC95) of bupivacaine for axillary brachial plexus block (ABPB). Methods: Following~     approval by the Research Ethics Committee, patients with a physical condition of I or II~     according to the American Society of Anesthesiologists, between 21 and 65 years of age were~     recruited and subjected to elective surgery of the hand and ABPB. The concentration of the~     anesthetic was determined using a step-up/step-down method and was based on the outcome of~     the preceding block.~   "
132051|NCT01838915|"~     A rapid and almost complete loss of CD4+ T cells from the gut associated lymphoid tissue~     (GALT) occurs early in HIV infection, with a permanent damage in the intestinal barrier,~     changes in gut microbiota, increased bacterial translocation and persistent immune~     activation, changes that are not restored after the initiation of antiretroviral therapy. The~     investigators hypothesize than an intervention targetting the enterocyte barrier and the gut~     microbiota might modify the gastrointestinal tract towards a bifidogenic microbiota and~     improve markers of bacterial translocation, inflammation, immune activation and endothelial~     dysfunction.~   "
132052|NCT01838902|"~     In this study, the investigators are interested to know if lower doses of Primaquine together~     with dihydroartemisinin-piperaquine can produce a similar effect of clearing both sexual and~     asexual parasites in asymptomatic carriers compared to the recommended dose of primaquine but~     with a decreased risk of haemolysis.~      Children (> 1 year) and adults with normal Glucose-6-phosphate dehydrogenase enzyme levels~     but with asexual Plasmodium falciparum parasites on the day of screening will be invited to~     take part in this study.~   "
132053|NCT01838889|"~     This study is an exploratory randomized controlled trial (RCT) of a group psychological~     intervention for postnatal depression in British mother's of south Asian origin. The aim is~     to evaluate the efficacy of a group psychological intervention (PHP) based on the principles~     of Cognitive Behaviour Therapy in treating depression in postpartum women. The hypothesis is~     that depressed British women of South Asian origin receiving the group intervention will show~     significant improvements in terms of severity of depression as compared to the treatment as~     usual (TAU) control group.~   "
132054|NCT01838876|"~     The objective of this study is to evaluate the long-term safety and tolerability of~     cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with Major~     Depressive Disorder (MDD).~   "
132055|NCT01838863|"~     Bleeding is the most avoidable cause of death in trauma patients. Up to one-third of severely~     injured trauma patients are found to be coagulopathic and forty percent of the mortality~     following severe injury is due to uncontrollable hemorrhage in the setting of coagulopathy.~     It has been established that early administration of fresh frozen plasma decreases mortality~     following severe injury, replacing lost coagulation factors, improving the coagulopathy and~     restoring blood volume. This study will determine if giving plasma to severely injured trauma~     patients during ambulance transport versus after arrival to the hospital will help reduce~     hemorrhage, thus decreasing both total blood product administration and mortality.~   "
132056|NCT01838850|"~     CS-8635 combines three widely prescribed antihypertensive medications, olmesartan~     medoxomil(OM), amlodipine (AML), and hydrochlorothiazide (HCTZ), to lower blood pressure. The~     purpose of the study is to evaluate the efficacy and safety of triple therapy with CS-8635~     compared with dual therapy in Korean patients with hypertension not controlled with dual~     fixed dose combination therapy (Olmetec® Plus). The treatments that will be used in this~     study are as follows: Run-in period -OM/HCTZ 20/12.5 mg (Olmetec® Plus 20/12.5 mg) ; Double~     blind treatment period - OM/AML/HCTZ 20/5/12.5mg (CS8635 20/5/12.5mg) + its matching placebo~     vs.OM/HCTZ 20/12.5mg (Olmetec® Plus 20/12.5 mg) + its matching placebo; Open label extension~     period - OM/AML/HCTZ 40/5/12.5mg (CS8635 40/5/12.5mg) or OM/AML/HCTZ 20/5/12.5mg (CS8635~     20/5/12.5mg).~   "
132057|NCT01838824|"~     This pilot study will document the efficacy of a behavioral intervention for Processing Speed~     (PS) in Multiple Sclerosis (MS), Speed of Processing Training (SPT), which has been~     successful used in the aging population in several studies. This study will (1) apply a~     treatment protocol for PS impairments, well-validated in aging, to persons with MS with~     impaired PS, and document its efficacy on standard neuropsychological (NP) tests (2) assess~     the effectiveness of the intervention utilizing global measures of daily life, including an~     objective measure (TIADL) (3) examine the long term impact of SPT. This study is unique in~     that it will be the first to evaluate the efficacy of a highly-manualized structured~     behavioral treatment for processing speed deficits in persons with MS utilizing the optimal~     methodology for carrying out such studies, a randomized clinical trial. Given the prevalence~     of PS deficits in the MS population and the significant impact such deficits have on everyday~     functioning, public safety, and overall quality of life, the identification of an effective~     intervention for PS deficits in MS could have a profound impact on the population and society~     as a whole.~   "
132082|NCT01838499|"~     The purpose of this study is to gain initial evidence for the safety, tolerability and~     efficacy of MEDI8968 for the treatment of subjects with moderate to severe hidradenitis~     suppurativa~   "
132083|NCT01838486|"~     Patients with Interstitial Cystitis / PBS will be treated with bladder thermal distention~     (BTD).~   "
132202|NCT01836926|"~     The two surgical options for lower 1/3 rectal cancer is APR and sphincter sparing procedures.~     Intersphincteric resection is procedure to treat very low rectal cancer within 2 cm from the~     dentate line to avoid permanent colostomy,improves the quality of life with better~     genitourinary function. Neoadjuvant chemo-radiotherapy is routine for T3 cases.~   "
132058|NCT01838811|"~     This pilot study will document the efficacy of a behavioral intervention for Processing Speed~     (PS) in Traumatic Brain Injury (TBI), Speed of Processing Training (SPT), which has been~     successful used in the aging population in several studies. This study will (1) apply a~     treatment protocol for PS impairments, well-validated in aging, to persons with TBI with~     impaired PS, and document its efficacy on standard neuropsychological (NP) tests (2) assess~     the effectiveness of the intervention utilizing global measures of daily life, including an~     objective measure (TIADL) (3) examine the long term impact of SPT. This study is unique in~     that it will be the first to evaluate the efficacy of a highly-manualized structured~     behavioral treatment for processing speed deficits in persons with TBI utilizing the optimal~     methodology for carrying out such studies, a randomized clinical trial. Given the prevalence~     of PS deficits in the TBI population and the significant impact such deficits have on~     everyday functioning, public safety, and overall quality of life, the identification of an~     effective intervention for PS deficits in TBI could have a profound impact on the population~     and society as a whole.~   "
132059|NCT01838798|"~     This is a prospective, single-center, pilot, cohort study. The first phase of this study is~     observational and the usual care of patients is maintained during the ICU stay, except for an~     interview with a psychologist preceding patient discharge. A phone interview at 2 months and~     a visit with a psychologist at four months after ICU discharge are specific to the study.~      The main objective of this study is to make a first estimate of the percentage of patients~     (CI = +- 10%) with cognitive impairment at four months after ICU discharge. The presence /~     absence of cognitive impairment will be determined by the D2 test.~   "
132060|NCT01838785|"~     A total 25 healthy subjects will be included in this study. Subjects between 20 and 80 years~     of age may be eligible for this study. Candidates are screened with a medical history and~     physical examination, and blood test.~   "
132061|NCT01838772|"~     The purpose of this study is to assess the effectiveness and tolerability of hepatitis C~     virus (HCV) treatment in HIV co-infected patients in routine health care services in Asia~     through a pilot model of care for treatment of HCV in resource-limited settings.~   "
132062|NCT01838759|"~     We aimed to investigate the role of bioimpedance spectroscopy for the diagnosis of~     hyponatremia~   "
132063|NCT01838746|"~     Young patients requiring myocardial revascularization are generally considered at low~     operative risk, but data on their immediate and late outcome are scarce. The decision-making~     process in these young patients is complicated by the potentially aggressive nature of~     premature coronary artery disease and their likely long expectancy of life, which expose them~     to a significantly higher risk of recurrent coronary events as well as the need of repeat~     revascularization. The lack of data on long-term outcome as well as on operative details (in~     particular, on the use of arterial grafts) and peri- and postoperative medication prevent any~     conclusive results on the durability either of coronary artery bypass grafting (CABG) or of~     percutaneous coronary intervention (PCI) in these young patients. Furthermore, recent~     advances in stents technology as well in peri- and postoperative medical treatment indicate~     the need a comparative study to define the baseline characteristics of patients aged < 50~     years undergoing either PCI or CABG and to evaluate their current immediate and late outcome.~   "
132064|NCT01838733|"~     Cerebral desaturations occur frequently in patients undergoing non-cardiac surgery. The~     definition of what constitutes a cerebral desaturation, the incidence of the phenomenon, the~     association between desaturations and perioperative outcome, and the mechanistic explanations~     of cerebral desaturations remain unexamined. This study seeks to identify the true incidence~     and magnitude of cerebral desaturations in high-risk non-cardiac surgical patients and the~     association between desaturations and perioperative outcome.~      The investigators will attempt to determine the following (1) The proper definition,~     incidence and severity of decreased cerebral saturation (rSO2) in high-risk non-cardiac~     surgical patients (2) the mechanisms surrounding decreases in rSO2 by correlating it with~     alterations in physiologic parameters (such as blood pressure, cardiac output, hemoglobin~     concentration, and carbon dioxide levels) and (3) to correlate the incidence and severity of~     decreased rSO2 with relevant perioperative.~      The investigators will also analyze a panel of inflammatory biomarkers to determine if these~     biomarkers have the ability to predict postoperative complications.~      The investigators will study 200 high-risk patients undergoing high-risk non-cardiac surgery.~     The investigators will determine the incidence and severity of decreases in rSO2, the~     associated factors with the occurrence of decreased rSO2, and the relationship between~     decreases in rSO2 and adverse perioperative outcome with a composite of well defined~     perioperative complications such as death, myocardial infarction, cerebrovascular accident,~     acute kidney injury, delirium, postoperative infections, and the need for mechanical~     ventilation.~   "
132065|NCT01838720|"~     To evaluate the feasibility and efﬁciency of zero ischemia laparoscopic radio frequency~     ablation assisted enucleation of T1a renal cell carcinoma in comparison with the conventional~     laparoscopic partial nephrectomy.~   "
132066|NCT01838707|"~     we aim to compare the analgesic effect of 0.125% bupivacaine HCL, 0.125% bupivacaine HCL +~     Morphine sulphate 3 mg, 0.125% bupivacaine HCL + Fentanyl 100 micro gram both at rest and~     mobilization maneuvers.~   "
132067|NCT01838694|"~     The primary objective of the study is to evaluate the safety, tolerability, and efficacy of 4~     weeks intravenous treatment with Cpn10 in subjects with mild to moderate active SLE.~   "
132068|NCT01838681|"~     To evaluate the long-term efficacy and safety of brexpiprazole as an adjunctive treatment to~     an antidepressant treatment (ADT) for adult patients with Major Depressive Disorder (MDD).~   "
132069|NCT01838668|"~     This is a multicenter study conducted in 2 parts:~      The primary objective in Part I of this study is to determine the efficacy of BG00012~     (dimethyl fumarate, DMF) on inflammatory brain magnetic resonance imaging (MRI) lesion~     activity (Gadolinium-enhancing lesions) when compared with placebo from 4 scans performed at~     Weeks 12, 16, 20, and 24 in participants with Relapsing Remitting Multiple Sclerosis (RRMS)~     including participants from the Asia-Pacific region.~      The secondary objectives in Part I of this study in this study population are to determine~     whether BG00012, when compared with placebo over 24 weeks, is effective in reducing the~     cumulative number of new Gadolinium-enhancing lesions from Baseline to Week 24; reducing the~     number of new or newly enlarging T2 hyperintense lesions on brain MRI scans at Week 24~     compared with Baseline.~      The primary objective in Part II (open label) of this study is to evaluate the long-term~     safety profile of BG00012 in eligible participants from Part I.~   "
132070|NCT01838655|"~     Background:~      - Oculocutaneous albinism, type 1B (OCA1B) is a genetic disease caused by problems in the~     gene that makes tyrosine. Tyrosine is an amino acid needed to produce pigment in the skin,~     hair, and eyes. People with OCA1B have pale skin, white hair, and light-colored eyes. Pigment~     in the back of the eye helps vision, so people with OCA-1B often have visual problems.~     Researchers want to see if a drug called nitisinone can help improve eye pigmentation and~     vision in people with OCA1B. Nitisinone is approved for treating a related genetic disease~     that causes problems with tyrosine, so it may help people with OCA1B.~      Objectives:~      - To see if nitisinone can help improve eye pigmentation and vision in people with OCA1B.~      Eligibility:~      - Individuals at least 18 years of age who have OCA1B.~      Design:~        -  This study will last about 18 months. It requires eight outpatient visits, each about 3~          months apart. Each visit will require 1 to 2 days of testing.~        -  Participants will be screened with a physical exam, eye exam, and medical history. They~          will have additional vision and neurological tests. They will be tested to see how their~          brain and retinas respond to light. They will also take hair and blood samples, and~          answer questions about diet.~        -  Participants will receive the study drug. They will take one pill a day for 1 year. They~          will keep track of the dose in a study diary.~        -  At the outpatient visits, participants will have the following tests:~        -  Medical history and physical exam~        -  Neurological and eye exams~        -  Retina function tests~        -  Tests of the skin and brain's response to light~        -  Blood and urine tests~        -  Dietary consultation~        -  Visual function questionnaire.~        -  After the end of the study, participants will return to the care of their regular eye~          doctor.~   "
132071|NCT01838642|"~     Background:~        -  Medullary thyroid cancer (MTC) represents 5% of thyroid cancers and presents as a~          hereditary (25% of cases) or sporadic (75% of cases) neuroendocrine malignancy.~        -  MTC arises from the parafollicular C-cells of the thyroid.~        -  Germline mutations in the rearranged during transfection (RET) proto-oncogene occur in~          virtually all of hereditary MTC cases, and somatic RET mutations occur in 50% of~          sporadic cases.~        -  Drugs targeting RET kinase such as vandetanib and cabozantinib have shown efficacy in~          the treatment of advanced or metastatic MTC, however, more effective RET inhibitors are~          needed for previously untreated patients as well as patients who have become refractory~          to other molecular targeted therapeutics (MTTs).~        -  Ponatinib, a drug that is Food and Drug Administration (FDA) approved as a therapy for~          chronic myelogenous leukemia~      (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), is a~     potent inhibitor of RET kinase.~      Primary Objective:~      -To determine the objective overall response rate (complete response [CR] + partial response~      [PR] by Response Evaluation Criteria in Solid Tumors (RECIST) to ponatinib in the treatment~     of patients with advanced or metastatic MTC previously treated with cabozantinib and~     vandetanib who: 1) have tumors with RET mutations and 2) have tumors without RET mutations.~      Eligibility:~        -  Patients must have histologically confirmed, unresectable, locally advanced or~          metastatic MTC, with measurable disease by RECIST criteria.~        -  Patients must have disease amenable to biopsy and be willing to undergo biopsy for~          molecular analysis, and also have adequate archival material from their thyroidectomy or~          from a tumor biopsy obtained prior to beginning any systemic therapy.~        -  Patients must have failed or been intolerant to prior treatment with both cabozantinib~          and vandetanib.~        -  The last dose of prior systemic therapy must be more than 28 days prior to the first~          dose of ponatinib~        -  Radiation therapy is permitted if the last treatment was received more than 28 days~          prior to the first dose of ponatinib.~      Design:~        -  Open label phase II trial with 2 treatment groups:~        -  RET mutation positive MTC, previously treated with vandetanib and cabozantinib~        -  RET mutation negative MTC, previously treated with vandetanib and cabozantinib~        -  Patients will receive ponatinib 30 mg orally daily until disease progression or until~          the development of intolerable side effects.~        -  Tumor response will be assessed by RECIST 1.1 criteria at 8 weeks and then every 12~          weeks thereafter. After one year on study, tumor response will be assessed every 16~          weeks.~        -  Patients will have a biopsy of their MTC for molecular analysis prior to initiating~          treatment with ponatinib. Patients will also have a biopsy of their MTC at the time of~          tumor progression, should that occur.~   "
132072|NCT01838629|"~     1. acquire the environmental iodine status of Hangzhou~        2. acquire the iodine status of population in Hangzhou~        3. acquire the prevalence of thyroid diseases in Hangzhou~        4. explore the association between iodized salt and thyroid disease~   "
132073|NCT01838616|"~     This was a clinical effectiveness trial designed to compare the effectiveness, safety, and~     tolerability of treatment with tapentadol prolonged release with that of oxycodone/naloxone~     prolonged release in non-opioid pre-treated subjects with severe chronic low back pain with a~     neuropathic pain component.~      Both tapentadol and the opioid oxycodone are effective in chronic severe pain and tapentadol~     and oxycodone/naloxone have shown advantages in gastrointestinal tolerability versus~     oxycodone. Therefore, it was of high scientific interest to compare the latter 2 analgesics~     with respect to gastrointestinal tolerability. Tapentadol may have advantages regarding the~     neuropathic pain-related symptoms of low back pain due to its 2 mechanisms of action.~   "
132074|NCT01838603|"~     There are quite a few qualitative studies done to find out patients experience of chronic~     pain. There are no studies on what the patients feel and what thoughts and feelings arise in~     the patients that are exposed to interventional pain management. This study aims to~     illuminate how it is to live through an interventional pain management program.~   "
132075|NCT01838590|"~     This study is to to evaluate the safety, tolerability, and efficacy of sofosbuvir (SOF) plus~     ribavirin (RBV) in Egyptian adults with genotype 4 hepatitis C virus (HCV) infection.~   "
132076|NCT01838577|"~     The investigators wish to document the distribution of EGFR somatic mutations, and assess the~     relationship between specific genotype, clinical demographic, therapy, and survival, in a~     large cohort of EGFR mutant NSCLC.~      The investigators also wish to comprehensively investigate the relationship between germline~     DNA and risk of EGFR mutant NSCLC developing, through a GWAS (Genome-Wide Association~     Studies) and candidate gene approach, and explore the relationship between germline DNA and~     clinical outcome, in order to potentially identify germline genetic modifiers of EGFR TKI~     (Tyrosine Kinase Inhibitor) outcome.~   "
132077|NCT01838564|"~     Over 50% of children dying from cancer still suffer from symptoms that could be effectively~     alleviated. The purpose of the Pediatric Quality of Life and Evaluation of Symptoms~     Technology (PediQUEST) Study was to evaluate whether providing feedback to families and~     providers about how the child is feeling improved child distress and quality of life (QoL) in~     children with advanced cancer.~      PediQUEST is a computerized survey that asks the child and/or parents how the child has been~     feeling, i.e. whether the child had any physical or emotional symptoms, as well as how other~     aspects of life, such as school and friends, are going. After the survey is complete a report~     that summarizes patient/parent answers is printed. When a child reports moderate to high~     distress from any symptom an email is automatically sent to the primary providers~     (oncologist, nurse, and psycho-social clinician as well as the pain and palliative care~     services) alerting them about the child's distress.~      In this study we evaluated whether using PediQUEST and providing printed reports to parents~     and providers reduced distress and improved quality of life in children with advanced cancer.~     In addition, we wanted to understand whether it was feasible to carry out a randomized~     controlled trial in children with advanced cancer. Finally, the data collected, will be used~     to describe the natural history of symptoms and quality of life as reported by the children.~      Children enrolled in the study (or their parents) were asked to complete a PediQUEST survey~     at most once a week. A random half of the children received the feedback intervention, i.e.~     patients, parents, and providers received printed reports (and emails if the child was in~     distress). The other half only completed the PediQUEST surveys and did not receive reports.~     We analyzed data collected over 20 weeks of follow-up to see whether receiving PediQUEST~     reports had any effect on child distress and quality of life.~   "
132078|NCT01838551|"~     The primary objectives of this study are to evaluate the efficacy of ascending doses of~     COR-003 in subjects with elevated levels of cortisol due to endogenous Cushing's Syndrome by~     assessment of reduction in Urinary Free Cortisol (UFC) concentrations and to identify the~     range of safe and effective doses of COR-003 that reduce mean UFC concentrations ≤ULN (upper~     limit of normal) of the assay at month 6 of the maintenance phase of dosing without a prior~     dose increase in that phase.~   "
132079|NCT01838538|"~     To study the efficacy and safety of intraperitoneal injection bevacizumab combined with~     intraperitoneal hyperthermic perfusion chemotherapy in treatment of malignant ascites of~     ovarian cancer. To analyze the clinical significance of the concentration change of vascular~     endothelial growth factor (VEGF) in ascites in treatment of intraperitoneal injection~     bevacizumab~   "
132086|NCT01838447|"~     Our research group has shown that almost all children with congenital heart disease (CHD) are~     vitamin D deficient following heart surgery. This work strongly suggests that the vitamin D~     intake presently recommended for healthy children, and also given to children with CHD, is~     inadequate to prevent vitamin D deficiency following surgery. Unfortunately, there have been~     no studies investigating any other vitamin D dose in children with heart disease. Recently, a~     higher dose of vitamin D intake has been approved (by the Institute of Medicine and Health~     Canada) and recent work on healthy children has shown it to be safe. The objective of this~     study is to determine whether this recently approved higher dose of vitamin D can safely~     reduce the number of children who are vitamin D deficient following surgery. This dose~     evaluation study will also evaluate whether it is possible to perform a large study (across~     Canada) to determine whether vitamin D supplementation can improve outcomes following~     surgery. It is hypothesized that a daily high dose vitamin D regimen, modeled on the~     Institute of Medicine daily upper tolerable intake level (UL), will significantly reduce~     vitamin D deficiency following CHD surgery, when compared with usual intake.~   "
132087|NCT01838434|"~     This Phase I/II trial studies the safety and effectiveness of lenalidomide with or without~     idelalisib. Biological therapies, such as lenalidomide, may stimulate the immune system in~     different ways and stop cancer cells from growing. Idelalisib may stop the growth of cancer~     cells by blocking some of the enzymes needed for cell growth. It is not yet known whether~     lenalidomide is more effective with or without idelalisib in treating mantle cell lymphoma.~   "
132088|NCT01838421|"~     In the context of the study a retrospective data collection of all anaesthesia protocols of~     children under the age of 12 which underwent surgery in the Charité - University Medicine~     Berlin, Campus Virchow - Klinikum in the years 2011 and 2012 shall be executed. The~     correlation of the tracheal tube sizes with the weight, age and height shall be evaluated.~     This data collection should serve to reevaluate the already published formulas e.g. (Rettberg~     M. et al., 2011).~   "
132089|NCT01838408|"~     This study aims to provide safety and efficacy data comparable to available over-the-counter~     bowel preparations prior to colonoscopy. While there are many bowel preparations available,~     most of them remain expensive and require prescription from a health provider. The~     investigators believe EZ2go Complete will provide a non-inferior colon cleansing in a more~     accessible way (over-the-counter).~      To accomplish this goal, the investigators decided to evaluate the proposed EZ2go combination~     versus currently available over-the-counter bowel preparations. The investigators believe the~     EZ2go kit will not be inferior to current FDA approved over-the-counter bowel preparations.~   "
132090|NCT01838395|"~     The goal of this clinical research study is to learn if BL-8040 in combination with~     cytarabine (Ara-C) can help to control the disease in patients with Acute Myeloid Leukemia~     (AML) that has relapsed or did not respond adequately to previous treatment. The safety of~     the study drug combination will also be studied.~   "
132091|NCT01838382|"~     Laparoscopic operative procedures have revolutionized gynecological surgery. These have~     several advantages: a smaller and more cosmetic incision, reduced blood loss and shorter~     postoperative stay, which cuts down on hospital costs. However, postoperative pain continues~     to be one complication, which results in an unpleasant experience for the patient and at~     times causes a delayed discharge. There are few studies about pain characteristics as one of~     laparoscopic hysterectomy complications. The purpose of this study is to investigate the~     prevalence and characteristics of shoulder pain, headache, abdominal pain, and back pain in~     patients undergoing total laparoscopic hysterectomy.~   "
132092|NCT01838369|"~     The purpose of this study is to investigate the effect of BI-505 on tumor burden in patients~     diagnosed with smoldering multiple myeloma.~   "
132093|NCT01838356|"~     The purpose of the study is to examine if blood flow in the brain before coronary artery~     bypass graft surgery has an effect on depression after surgery.~      The main hypothesis of the study states that pre-surgical blood flow in the brain will be an~     independent risk factor for depression after surgery after adjusting for other risk factors~     such as gender, pre-CABG depression, social support, medical comorbidity burden,~     socioeconomic status, and neuroticism.~   "
132094|NCT01838343|"~     Rapid response team systems have been implemented in numerous hospitals throughout the world~     with the goal of improving the identification and safety of hospitalized patients who are~     clinically deteriorating. Despite their theoretical benefit, rapid response systems have not~     been proven in the medical literature to ultimately change outcomes.~      The traditional physical exam is helpful in evaluating and treating unstable medical patients~     during these types of events but has significant limitations of deceased sensitivity and~     specificity of findings. Ultrasound is a known tool for more accurately assessing patients in~     shock and respiratory failure in the ICU by highly trained operators but to the investigators~     knowledge has not been studied in the setting of rapid response events on hospital wards by~     critical care fellows after focused training. The investigators aim to assess the impact of~     ultrasound performed by critical care fellows during rapid response events.~   "
132095|NCT01838330|"~     Loss of kidney function results in accumulation in the blood of molecules that are either~     excreted or metabolized by the kidney. Collectively, these molecules are termed Uremic~     Retention Molecules (URMs) or toxins. It is increasingly recognized that colonic bacterial~     metabolites like p-cresyl sulfate and indoxyl sulfate that are absorbed from the colon and~     excreted by the kidney may contribute to the pool of compounds implied in uremic toxicity.~     Indeed, these URMs have been linked to increased levels of inflammation markers, chronic~     kidney disease (CKD) progression, cardiovascular disease and overall mortality in CKD and/ or~     hemodialysis patients. Therefore, interventions that target the production or absorption of~     URMs from the gut might decrease inflammation and oxidative stress that are commonly seen in~     the uremic milieu. The National Health and Nutrition Examination Survey III (NHANES III) data~     show that high dietary fiber intake is associated with decreased serum levels of C-reactive~     protein (CRP) in those with and without CKD and these associations are much stronger in the~     CKD population. A possible explanation of this effect is that a high fiber diet in CKD~     patients modulates the bacterial production, intestinal absorption and finally the serum~     levels of URMs like p-cresyl sulfate and indoxyl sulfate, which in turn results in decrease~     in inflammation.~      OBJECTIVES:~      Hypothesis:~        1. Higher serum levels of markers of inflammation such as high sensitivity C-reactive~          protein (hsCRP), interleukin 6 (IL-6) and tumor necrosis factor (TNF) -α seen in stage 4~          CKD (estimated Glomerular Filtration Rate 15-29 ml/min/1.73 m2) compared to stage 2 CKD~          (estimated Glomerular Filtration Rate 60-89 ml/min/1.73 m2) is partly explained by the~          higher circulating levels of URMs (p-cresyl sulfate and indoxyl sulfate) in stage 4 CKD,~          and~        2. Dietary supplementation in stage 4 CKD with 30g/d of a soluble fiber Psyllium (brand~          name-Metamucil TM) will decrease circulating URMs levels and thereby, decrease serum~          levels of inflammation markers and urinary levels of transforming growth factor (TGF)-β,~          a marker of kidney fibrosis.~   "
133018|NCT01826188|"~     There are many reports about efficacy of Cannabis in Crohn's disease but no controlled~     trials. The aim of the proposed trial is to investigate the efficacy of oil containing the~     cannabinoids THC and CBD given by mouth for induction of remission in Crohn's disease.~   "
132096|NCT01838317|"~     This study is being done to determine whether or not addition of the oral medication,~     pioglitazone to standard chemotherapy, results in improvement of blood tests that measure the~     body's ability to utilize sugar (glucose and insulin metabolism). In addition the~     investigators want to determine whether or not treatment with pioglitazone results in (1)~     improvement in the size of the tumor, (2) weight gain, (3) improved ability to function~     during the day and (4) quality of life.~   "
132097|NCT01838304|"~     Endoscopic sedation requires titration of propofol to deep sedation without minimum overshoot~     into general anesthesia. This skill is demanding and acquired slowly. Probability Ramp~     Control (PRC) simplifies this by providing the clinician with a simple infusion sequence that~     permits gradual titration of propofol. The purpose of this study is to compare the~     performance of this technology to that of experienced anesthesia providers in endoscopic~     sedation.~   "
132098|NCT01838291|"~     Observational, open label, prospective, multi-center, post-marketing drug surveillance~     program.~   "
132099|NCT01838278|"~     - Justification: Prematurely born children have an increased prevalence of neurodevelopment~     problems in the first two years. Knowledge regarding the effects of early intervention~     programs is essential to the follow up of these children and the families.~      -Hypothesis: The Vojta Therapy Model showed beneﬁcial effects on motor development outcomes~     reported by Bayley Sales of Infant Development-Second Edition, in the first 18 months of life~     on European sample.~   "
132100|NCT01838265|"~     1. Using multiparametric MRI Ultrasound-guided or MRI-guided biopsies will allow more~          accurate sampling of the tumors and therefore will increase the rate of progression on~          early (first and second) surveillance biopsies and decrease the rate of progression on~          late (third and further) surveillance biopsies compared to Transrectal Ultrasound-guided~          biopsies.~        2. Quality of life (QoL) will be similar in patients undergoing MRI Ultrasound or~          MRI-guided and Transrectal Ultrasound-guided biopsies.~        3. Biomarker expression levels will correlate with biopsy progression.~   "
132101|NCT01838252|"~     Lid retraction is a difficult problem encountered in oculofacial plastic surgery. It can~     result from previous surgery, radiotherapy or cicatrizing disease or it may be idiopathic.~     Whatever the aetiology, the cosmetic appearance is troublesome to patients and, can be~     damaging to the cornea. The definitive therapy for lid retraction is surgical, and often~     involves complicated procedures including tissue grafting.~      Hyaluronic acid gels (HAG) have been FDA approved for the treatment of facial rhytids by~     subcutaneous injection and volume addition. These gels have gained wide popularity in for~     cosmetic applications in filling volume deficit areas. Functional applications in the~     periorbital area have also been described including the filling of volume deficit~     anophthalmic orbits, ectropion and loagophthalmos. Additionally, pilot studies have found HAG~     to be useful in correcting both upper and lower eyelid retraction, with good effect.~      The purpose of this investigation is to define the clinical utility of HAG correction of~     lower eyelid retraction in terms of anatomic (lid position), quantitative (dry eye signs on~     cornea) and qualitative effects (symptom severity).~      Our hypothesis is that HAG correction of lower eyelid retraction will improve patient~     comfort, clinical signs of dry eye and aesthetic self image.~   "
132102|NCT01838239|"~     The purpose of this study is to examine the variation between individuals in blood lipid~     metabolites, and the changes in these metabolites in response to omega-3 fatty acids in~     patients with immunoglobulin A nephropathy (IgAN) and in healthy subjects. The hypothesis is~     that measuring variation among individuals and changes in response to omega-3 fatty acids~     comprehensively by using metabolomics will help to identify those individuals who are~     responders and those who are non-responders to omega-3 fatty acids as an anti-inflammatory~     intervention.~   "
132103|NCT01838226|"~     Prevention of cardiovascular disease is a primary focus of the Secretary's New Models of Care~     Transformational Initiative. However, prevention has been hard to accomplish. The VA is~     committed to using group visits to address a wide array of primary care problems. Coaching is~     a method to help Veterans set and reach health goals by helping them overcome barriers to~     behavior change. Coaching can be performed one-on-one or in groups. This study will test the~     effectiveness of a group prevention coaching (GPC) intervention in improving cardiovascular~     risk. GPCs will focus on changing a behavior of the patient's choice that is likely to lead~     to improvements in heart disease risk. The coach will adopt a problem-solving approach to~     helping Veterans make these improvements. The primary outcome will be change in 10-year risk~     of major cardiac event; the investigators will also assess improvements in food choice,~     physical activity and weight.~   "
132104|NCT01838213|"~     This project aims at investigating the duration of human fecal carriage of bacteria harboring~     plasmid-borne resistance genes expressing Extended Spectrum beta-lactamases (ESBL), risk~     factors for infections with such bacteria and persistence, mobility and spread of ESBL in the~     environment and within households. It also aims to compare different methods of detecting~     ESBL carriage and treat patients with urinary tract infection caused by these bacteria.~   "
132105|NCT01838200|"~     This is an open-label, dose-escalation, non-randomized, phase I study in patients with~     histologically confirmed Stage III or IV melanoma and at least three metastatic cutaneous or~     subcutaneous lesions suitable for: intralesional (IL) injection (1 lesion), accessible for~     biopsy (1 lesion), and response evaluation by RECIST (v1.1) and modified RECIST (irRC) (1~     lesion). The primary objective is to determine whether IL administration of BCG followed by~     intravenous (IV) infusion of ipilimumab is safe. Ipilimumab (YERVOY®) is the monoclonal~     anti-CTLA-4 antibody approved by the FDA and TGA as anticancer therapy for melanoma.~     Secondary objectives of the study are: a) clinical efficacy, to document whether this~     combination therapy induces tumour responses; and b) immunogenicity, to identify if the~     combination induces immune responses against the tumours. All patients will be included in~     the analysis of efficacy and immunogenicity.~      Cohort 1 (9 patients with <10mm induration after tuberculin Purified Protein Derivative [PPD]~     test): Group 1 (3 patients) will receive one IL injection of 200 µl BCG containing 0.16 -~     0.64 x 106 cfu followed by four IV infusions of 3 mg/kg ipilimumab every 3 weeks, starting on~     day 36. Group 2 (3 patients) and 3 (n=3) will receive 200 µl BCG containing 0.8 - 3.2 x 106~     cfu and 4.0 -16.0 x 106 cfu, respectively, followed by the same ipilimumab regimen. Safety~     will be evaluated in this cohort.~      Cohort 2 (up to 9 patients with ≥10mm induration after PPD test): Enrolment will start after~     the final patient in Cohort 1, Group 1 has reached study week 7. Then enrolment can proceed~     in parallel for Cohort 2 and Cohort 1 Groups 2 and 3. Patients will receive 0.16 -0.64 x 106~     cfu BCG followed by four IV infusions of 3 mg/kg ipilimumab every 3 weeks, starting on day~     36. Evaluation of safety in this cohort will be observational.~   "
132216|NCT01836744|"~     Previous in a randomized way, it will be performance 12 bilateral sinus lift with autologous~     bone in one side and the in other with xenograft material. After 6 mouths we will place 1 to~     3 implants in each side and analyse the survival rate and possibles differences related to;~     prosthesis failure; biological and prosthetic complications; peri-implant marginal bone level~     changes.~   "
132106|NCT01838187|"~     Currently there is no known effective treatment for patients with advanced stage~     neuroblastoma, pheochromocytoma, or paraganglioma who have relapsed or not responded to~     standard therapy. In previous studies that used 131I-MIBG as a potential anti-cancer therapy,~     a decrease in the size of tumors was seen in some of the children and adults. This research~     study will continue to evaluate the side effects of 131I-MIBG when treating children and~     adults with neuroblastoma, pheochromocytoma, or paraganglioma. The 131I-MIBG compound is~     intended to work by selectively delivering the radioactive iodine to the tumor cells, which~     is then intended to result in their destruction.~      The purpose of this research study is to:~        -  Make 131I-MIBG therapy available to patients with advanced neuroblastoma,~          pheochromocytoma, or paraganglioma~        -  Further assess the side effects of 131I-MIBG therapy~   "
132107|NCT01838174|"~     We hypothesize that the novel melanocortin-mediated anti-inflammatory effects of~     Adrenocorticotropic hormone (ACTH) will reduce axonal loss following ON by limiting~     inflammatory optic nerve injury. We will compare the effect of ACTH and intravenous~     methylprednisolone therapy on axonal injury following ON using ocular coherence tomography~     (OCT), a sensitive, reproducible and noninvasive tool to measure retinal nerve fiber layer~     (RNFL) thickness.~      The primary outcome will be the average RNFL thickness at 6 months. Additional pre-specified~     statistical analyses will compare the difference in the mean RNFL thickness at 6 months in~     the affected eye between the IV methylprednisolone- and Acthar-treated groups, and the mean~     6-month affected eye RNFL thicknesses adjusted for the baseline unaffected eye RNFL. The~     secondary outcome measure will examine the frequency of optic nerves with RNFL swelling~     between the IV methylprednisolone- and Acthar-treated groups at 1 and 3 months. The tertiary~     outcome will be changes in mfVEP amplitude and latency, ONHP detection, and pupillary~     diameter (UTSW only). A predefined exploratory outcome will compare the ganglion cell plus~     inner plexiform layer (GC+IPL) thickness at 6 months between treatment groups~   "
132108|NCT01838161|"~     The proposed project develops a community and school-based intervention to enhance~     understanding of the importance all age-appropriate vaccinations, and uses an innovative,~     comprehensive approach (Project INSPIRE - Instilling Necessary Sickness Prevention with~     Immunizations Reaching Everyone) to ensure that all parents of adolescents are advised of all~     age-appropriate vaccines for sickness prevention. The investigator will develop a novel set~     of targeted video vignette persuasive informational decision aids (including target~     population representatives) to enhance lay understanding of recommended adolescent (or~     catch-up) vaccines. The Investigator will also partner with school districts to develop a~     replicable social marketing vaccination event program (Project INSPIRE) to encourage parents~     and teens to publicly vaccinate at community events and during drop-in school nursing clinic~     hours. The project will test the efficacy of the video-based health education intervention +~     standard of care to ideal standard of care (social marketing vaccination event program)~     approaches to immunize adolescents in this region.~   "
132109|NCT01838148|"~     The primary aim is to perform the largest study worldwide to evaluate novel biochemical and~     electrocardiographic signatures alone as well as in combination with the standard 12-lead~     exercise ECG in the detection of exercise-induced myocardial ischemia (diagnostic endpoint).~     The secondary aim is to evaluate these innovative tools in the risk prediction for the~     occurrence of cardiovascular death and acute myocardial infarction during long-term~     follow-up.~   "
132110|NCT01838135|"~     Self-efficacy predicts behavioural and rehabilitation outcomes and may be an important~     psychological factor for wheelchair mobility. A feasibility study will evaluate a novel~     self-efficacy enhanced wheelchair training intervention for older adults (WheelSeeU) to~     determine if: 1.WheelSeeU is feasible to administer; 2. WheelSeeU improves wheelchair use,~     confidence for wheelchair use, wheelchair mobility, and satisfaction with participation in~     older adults compared to group-based information sessions; and 3. the study design is~     appropriate. This feasibility study will allow for study design and protocol refinement and~     will provide pilot data for an experimental trial.~   "
132111|NCT01838122|"~     Women with PCOS have been observed to be potential diabetics.Recently,American Diabetes~     Association has suggested screening of women with PCOS for HbA1C.~   "
132112|NCT01838109|"~     Patients who underwent major gastrointestinal surgery is potentially at risk of malnutrition~     due to reduced oral intake, increased nutritional need, reduced gastrointestinal absorption~     function, and/or metabolic changes after surgery. The postoperative malnutrition is~     associated with low quality of life and seems to be related long-term nutritional status.~     This study is a multicenter, open-labeled prospective randomized clinical trial to examine~     the effect of postoperative oral nutritional supplements (ONS) after major gastrointestinal~     surgery by comparing the change of body weight and other nutritional parameters between the~     experiment group that is supplied with ONS and the control group without ONS.~   "
132113|NCT01838096|"~     This study will evaluate clinical outcome on patients who undergo cementless 4th generation~     ceramic (BIOLOX®delta, CeramTec GmbH, Plochingen, Germany) on ceramic (CoC) bearing total hip~     aArthroplasty (THA) in patients younger than 30 years.~   "
132114|NCT01838083|"~     Primary Objective:~      To demonstrate equivalence in exposure to insulin glargine given as test formulation T and~     reference formulation R in steady state conditions after 6 once-daily subcutaneous (SC) doses~      Secondary Objective:~        -  To assess relative Pharmacodynamic activity of the insulin glargine test formulation T~          to the insulin glargine reference formulation R in steady state conditions after 6~          once-daily SC doses~        -  To assess the safety and tolerability of the test and reference formulations of two new~          insulin glargine formulations~   "
132115|NCT01838070|"~     This safety surveillance study is being conducted in accordance with Korea Food and Drug~     Administration (KFDA) Basic standard for reexamination of new drug.~      Primary objective:~        -  To assess the safety of AVAXIM 160U (Hepatitis A vaccine) administered under the routine~          practice, according to Korea Food and Drug Administration Basic standard for~          reexamination of new drug based on the pharmaceutical law in Korea.~   "
132286|NCT01835821|"~     This clinical study has the objective to compare the longevity and the clinical behaviour~     (CDA Index, soft tissue behavior, success and survival rates) of single cemented ceramic~     crowns made with shaded zirconia (NobelProceraTM Shaded Zirconia) and NobelProceraTM full~     contour crowns IPS e.max CAD lithium disilicate on molars.~   "
132116|NCT01838057|"~     To evaluate the impact of painPRIMER in a prospective six-month clinical investigation~     looking at clinical outcomes, health care professional and patient satisfaction, healthcare~     resource use, productivity and direct and indirect costs. The hypothesis is that early~     identification of the presence of neuropathic pain and back pain related comorbidities, to~     direct appropriate pharmacologic and non-pharmacologic treatment, painPRIMER would improve~     patient outcomes and reduce patient cycling, inappropriate use of imaging and surgery,~     thereby reducing costs and productivity loss associated with these inefficiencies.~   "
132117|NCT01838044|"~     The purpose of this study is to determine if treatment with celecoxib and pregabalin together~     would prove to be more effective in relief of pain than treatment with celecoxib alone in~     people who have chronic low back pain with a probable neuropathic component.~   "
132118|NCT01838031|"~     Estimate the proper thyroid screening method during pregnancy. Evaluate if maternal~     subclinical hypothyroidism treatment during pregnancy result in improved pregnancy outcome~     and cognitive function in the children.~   "
132119|NCT01838018|"~     The purpose of this study is to learn whether blood flow in the brain is normal in people~     with pantothenate kinase-associated neurodegeneration (PKAN). Specifically, preliminary data~     suggest a region of the brain called the globus pallidus (GP), a key region affected by PKAN,~     may have reduced blood flow. Standard MRI and perfusion scanning techniques will be used to~     learn about cerebral blood flow in the globus pallidus and compare it to blood flow in other~     brain regions as well as to healthy controls.~   "
132120|NCT01838005|"~     The goals of the proposed study are to: 1) test whether small, increasing cash payments to~     HIV-infected pregnant women, on the condition that they attend scheduled clinic visits and~     receive proposed services, will increase the proportion of women who receive the most~     effective antiretroviral regimen they are eligible for by the time of delivery, and 2)~     elucidate factors that facilitate or inhibit the uptake and adherence to the PMTCT cascade,~     and to what extent the conditional cash payment program addresses these factors.~      This intervention will be implemented and evaluated within our well-established PMTCT program~     in Kinshasa, Democratic Republic of Congo (DRC),~   "
132121|NCT01837992|"~     The Melanesian states of the Western Pacific (Papua New Guinea, Solomon Islands and Vanuatu)~     represent a unique and especially prescient challenge to malaria control and elimination.~      While the use of bed nets and other vector control and case management measures have achieved~     major advances in overall malaria control, the P. vivax and P. ovale species account for an~     ever-increasing burden of clinical disease.~      The lack of effective treatment of the hypnozoite stages of infection with these species~     result in ongoing relapses and a continuing reservoir of infection.~      The only known drug effective for treatment of the hypnozoite stage is primaquine; however~     the safe and effective dose of this drug in malaria treatment is still unclear.~      A recent study evaluated the safety and efficacy of two primaquine dosing regimens (0.25mg/kg~     and 0.5mg/kg) in a population in New Ireland province, PNG. This study aims to replicate this~     methodology in Vanuatu and Solomon Islands, to provide a more complete picture of primaquine~     efficacy and safety in each of the three countries of this region.~   "
132122|NCT01837979|"~     There are 26,600 Down Syndrome newborns every year in China. The economic burden of this~     disease is 65,000 USD for lifetime of every patient. The common prenatal screening and~     diagnosis procedure for fetal chromosomal abnormalities in China is maternal serum prenatal~     screening in second trimester followed by amniocentesis. The detection rate of MSS is 70%-75%~     with 5% false positive rate. There are only 13.9% of pregnant women can receive prenatal~     screening testing in China. It is very urgent that we build a training system and convenient,~     efficient, cost-effective procedure suitable to rural China.~      The use of dried blood spots (DBS) technology in conjunction with the second trimester~     prenatal screening protocol has been proved to be as efficient as serum screening by our~     previous study. Noninvasive prenatal testing that uses cell free fetal DNA (cff DNA) from the~     plasma of pregnant women offers a tremendous potential for fetal chromosomal abnormalities. A~     positive test should be followed by invasive prenatal diagnosis to confirm the test results.~     Cff DNA is a good supplement to the DBS technology in rural China. A combination of the two~     methods can increase the screening rate and accuracy without increasing the demand of~     amniocentesis and cytogenetic test. This procedure with adequate training system should be~     suitable to rural China.~      Our study will build a training system for DBS and cffDNA prenatal screening procedure in~     Pinggu, Beijing. Two thousand pregnant women will receive prenatal screening. DBS sample will~     be collected in the second trimester, Cff DNA is offered to confirm the positive screening~     test results, and lastly amniocentesis is offered for confirmation of the test results. All~     of the pregnancy and neonatal outcomes will be followed. We can estimate the efficiency and~     cost-effectiveness of DBS followed with cff DNA screening procedure.~   "
132123|NCT01837966|"~     The study is designed to see if lavender aroma therapy reduces pre-operative anxiety in~     breast surgery patients.~   "
132124|NCT01837953|"~     Binge Eating Disorder (BED) affects as many as 3% of women and men in Ontario, 8% of obese~     individuals, and 30% to 50% of those participating in weight loss programs. BED, the most~     common eating disorder, is characterized by over-eating with loss of control (i.e., binge~     eating), but with no purging (e.g., vomiting).Our previous research indicates that the total~     health care costs for women with BED is 36% higher than the Canadian average for women of a~     similar age, and that health care costs significantly decreased following intensive treatment~     at our Centre. The main goal of our study is to inform the development of a stepped care~     approach to the treatment of BED. Stepped care involves providing easily accessible low~     intensity treatment first, and then providing more expensive intensive treatment second, if~     necessary. The second goal is to assess if a second more intensive step of treatment provides~     added value. Although stepped care for BED is suggested by a number of clinicians and~     researchers, no study adequately tests predictors of who might benefit from minimal treatment~     alone and who would require the more intensive second step. The results of this study will~     guide decision making regarding who benefits from stepped care, and will help to increase the~     accessibility, availability, and cost effectiveness of psychological treatments for BED.~   "
132125|NCT01837940|"~     The purpose of this study is to investigate the effect of a daily supplement consisting of~     the probiotic bacteria, Lactobacillus reuteri, on the digestive health among persons 65 years~     and older.~   "
132126|NCT01837927|"~     This study will assess the Efficacy of NVA237 (50 μg o.d) using tiotropium (5μg μg o.d) as~     active control in COPD patients.~   "
132300|NCT01835626|"~     Chemotherapy, radiation therapy, and surgery are standard treatments for basal cell carcinoma~     at most institutions. The purpose of this study is to determine whether adding vismodegib to~     radiation (chemoradiotherapy) is safe and tolerable. The purpose of this study is to assess~     the safety and tolerability of combined radiation therapy and vismodegib. This combination~     may increase the chances of the tumors being destroyed or unable to spread to other parts of~     the body in people with locally advanced basal cell carcinoma of the head and neck.~   "
132127|NCT01837914|"~     Obstructive Sleep Apnea is a serious medical condition affecting an estimated 1-5% of~     children. The disease is believed to have several overlapping causes including large tonsils~     and small or narrow jaws. This prospective, randomized cross-over study will evaluate the~     effectiveness of orthodontic treatment of narrow upper teeth and jaws compared to the current~     standard of care which is surgical removal of the adenoids and tonsils.~      Patients will be evaluated by both an orthodontist and ENT physician, complete a series of~     questionnaires and undergo an overnight sleep study, both initially and after undergoing the~     randomized treatment. Patients who on reassessment have residual symptoms of sleep apnea will~     then be crossed over and receive the other form of treatment. The levels of improvement to~     both subjective (questionnaire) and objective (overnight sleep study) measures of sleep apnea~     will then be compared.~      The null hypothesis is there is no significant difference in improvement between maxillary~     expansion and adenotonsillectomy in the objective and subjective outcome measures in children~     with mild to moderate obstructive sleep apnea.~   "
132128|NCT01837901|"~     The purpose of this study is to determine the long term effects of transcorneal~     electrostimulation (TES) in patients with retinitis pigmentosa (RP). In a prior study~     (NCT00804102) the results of short term stimulation pointed to a positive effect on the~     visual field and other parameters. In this study, the patients will be stimulated with either~     0%, 150% or 200% of the individually determined phosphene threshold.~   "
132129|NCT01837888|"~     Self-efficacy predicts behavioural and rehabilitation outcomes and may be an important~     psychological factor for wheelchair mobility. A feasibility study will evaluate a novel~     self-efficacy enhanced wheelchair training intervention (WheelSee) to determine if:~     1.WheelSee improves self-efficacy compared to standard care; 2. study design is appropriate;~     and 3. The WheelSee intervention protocol is suitable. This feasibility study will allow for~     study design and protocol refinement and will provide pilot data for an experimental trial.~   "
132130|NCT01837875|"~     The goal of the proposed project is to enhance the Principal Investigator's research ability~     to conduct behavioral interventions for people with lupus. This includes intervention design,~     implementation, data collection and data analysis. The Intervention to Improve Quality of~     life for African-AmericaN lupus patients (IQAN) Project is designed to examine whether a~     uniquely tailored intervention program can improve quality of life, decrease indicators of~     depression, and reduce perceived and biological indicators of stress in African American~     lupus patients. This study builds on three decades of work conducted in the field of~     arthritis self-management but differs in that the intervention mode, the disease (lupus), and~     the study population (African-Americans) are unstudied or understudied. The IQAN Project will~     use the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) model as its~     theoretical framework. This program has three specific aims. The first aim seeks to design a~     three armed randomized, wait list controlled trial that employs a patient-centered~     'a-la-carte' approach that offers subjects a variety of modes of interaction, allowing them~     to choose as many or few as they wish. The second aim is to assess the intervention, using~     the RE-AIM model framework. The third aim, to be achieved before the first aim, is to use~     previously collected data to characterize patient-centric barriers to care in~     African-American lupus patients, in order to identify trends in patient needs and desires, as~     well as correlates of non-response and non-compliance that can be used in the development and~     refinement of the intervention.~   "
132131|NCT01837862|"~     This is a study to determine the safety and efficacy of the drug, mebendazole, when used in~     combination with standard chemotherapy drugs for the treatment of pediatric brain tumors.~     Mebendazole is a drug used to treat infections with intestinal parasites and has a long track~     record of safety in humans. Recently, it was discovered that mebendazole may be effective in~     treating cancer as well, in particular brain tumors. Studies using both cell cultures and~     mouse models demonstrated that mebendazole was effective in decreasing the growth of brain~     tumor cells.~      This study focuses on the treatment of a category of brain tumors called gliomas. Low-grade~     gliomas are tumors arising from the glial cells of the central nervous system and are~     characterized by slower, less aggressive growth than that of high-grade gliomas. Some~     low-grade gliomas have a more aggressive biology and an increased likelihood of resistance or~     recurrence.~      Low-grade gliomas are often able to be treated by observation alone if they receive a total~     surgical resection. However, tumors which are only partially resected and continue to grow or~     cause symptoms, or those which recur following total resection require additional treatment,~     such as chemotherapy. Due to their more aggressive nature, pilomyxoid astrocytomas, even when~     totally resected, will often be treated with chemotherapy. The current first-line treatment~     at our institution for these low-grade gliomas involves a three-drug chemotherapy regimen of~     vincristine, carboplatin, and temozolomide. However, based on our data from our own~     historical controls, over 50% of patients with pilomyxoid astrocytomas will continue to have~     disease progression while on this treatment. We believe that mebendazole in combination with~     vincristine, carboplatin, and temozolomide may provide an additional therapeutic benefit with~     increased progression-free and overall survival for low-grade glioma patients, particularly~     for those with pilomyxoid astrocytomas.~      High grade gliomas are more aggressive tumors with poor prognoses. The standard therapy is~     radiation therapy. A variety of adjuvant chemotherapeutic combinations have been used, but~     with disappointing results. For high-grade gliomas this study will add mebendazole to the~     established combination of bevacizumab and irinotecan to determine this combinations safety~     and efficacy~   "
132132|NCT01837849|"~     To compare the therapeutic efficacy of recombinant human brain natriuretic peptide (rhBNP)~     with dobutamine on acute decompensated heart failure patients with different blood BNP levels~   "
132133|NCT01837836|"~     The purpose of this study is to assess the drinking water handling practices at household~     level and to determine the effect of health education on the drinking water handling.~     Participants from study villages, mainly homemakers, school children and water tank operators~     who are willing to participate, will be targeted.~      Baseline assessment of household practices related to water will be done. Followed by a~     health education regarding the healthy practices will be given to them. Practice of household~     water chlorination will be promoted. The healthy behavior will be reinforced through~     reminders and community activities of self help groups for one year.~      The study participants will be benefited from survey in terms of~        1. Improved knowledge and practices of drinking water handling~        2. Risk reduction of water borne illness to family members~   "
132146|NCT01837667|"~     The purpose of this study is to test the safety of an investigational drug called LB-100 for~     Injection for treatment of solid tumors, when given with or without docetaxel. LB-100 is a~     small molecule that in laboratory and animal studies has shown activity when used by itself~     or together with drugs approved to treat some types of cancer (chemotherapeutic agents).~     Docetaxel is a drug that has been approved for the treatment of some types of cancer; one of~     the trade names for docetaxel is Taxotere®. The study is in 2 parts. Part 1: Patients will~     receive injections of LB-100. Part 2: Patients will receive injections of LB-100 and~     docetaxel. This is the first study where LB-100 for Injection will be used in humans.~   "
133033|NCT01825980|"~     To evaluate the antiviral activity of 3 days of BZF961. To determine safety and tolerability~     of BZF961 in HCV patients. To evaluate pharmacokinetics of BZF961 in HCV patients.~   "
132134|NCT01837823|"~     Coronary artery disease (CAD) remains a leading cause of death in most countries. It is well~     known that the reduction of cholesterol levels by statin therapy is associated with~     significant decreases in plaque burden. REVERSAL, ASTEROID, and more recently the SATURN II~     trial showed that in patients with CAD, lipid lowering with atorvastatin or rosuvastatin~     respectively reduced progression of coronary atherosclerosis, even causing plaque regression~     of some lesions. CAD clinical events are related to plaque instability due to lipid content~     and activity within the atherosclerotic plaque. The investigators recently completed the~     YELLOW I study, and identified that intensive statin therapy (rosuvastatin 40mg) was~     associated with a reduction in the amount of lipid in obstructive coronary plaques, as~     measured by near-infrared spectroscopy (NIRS). The YELLOW II study is designed to expand and~     build upon these results, and to provide mechanistic insights into the potential benefits of~     intensive statin therapy on atherosclerotic plaques.~   "
132135|NCT01837810|"~     The purpose of this study is to determine if ibuprofen use after electrocautery tonsillectomy~     increases the post-tonsillectomy hemorrhage rate.~      Hypothesis: Use of ibuprofen does not increase the post-tonsillectomy hemorrhage rate.~      Primary outcome: Rate of tonsillar hemorrhage following adult tonsillectomy in those~     receiving narcotic pain medications plus ibuprofen compared to those receiving narcotics~     alone.~      Secondary outcome: Determine whether ibuprofen, a non-steroidal anti-inflammatory drug~     (NSAID), decreases post tonsillectomy pain, narcotic pain medication use, or cost of pain~     management.~   "
132136|NCT01837797|"~     To evaluate the efficacy and safety of brexpiprazole as adjunctive treatment in elderly~     patients with Major Depressive Disorder (MDD)~   "
132137|NCT01837784|"~     Guidelines recommend measuring end organ damage and in particular arterial stiffness in~     patients with hypertension. However, until now it was not possible to measure arterial~     stiffness with the use of simple methods. Recently, novel and innovative devices offering~     determination of arterial stiffness and central hemodynamics from simple and non-invasive arm~     cuff measurements have now become available. This study therefore evaluates the value of~     non-invasively measured arterial stiffness and central hemodynamics for guiding~     antihypertensive treatment in selected patient populations (i.e. elderly patients, patients~     with diabetes mellitus, patients with heart failure, and patients with resistant~     hypertension).~   "
132138|NCT01837771|"~     The Epiphrenic III Pilot Trial investigates whether a diaphragmatic stimulation by~     interventionally placed electrodes may improve heart function, symptoms and functional~     capacity in patients with severe heart failure.~   "
132139|NCT01837758|"~     Aim of the study is a description of changes in platelet function during continuous~     veno-venous hemodialysis or hemofiltration in patients on an intensive care unit using the~     Multiplate system.~   "
132140|NCT01837745|"~     Open-label randomized phase III trial, using a non-inferiority comparison design. After~     randomization,patients will receive either post-operative radioiodine ablation with an~     activity of 1.1 GBq (30 mCi) after stimulation by rhTSH, and then be followed-up (ablation~     group) or be followed-up (without postoperative radioiodine ablation) (follow-up group).~      The objective is to assess the non-inferiority of the proportion of patients without~     tumor-related event evaluated at three years after randomisation in the absence of~     radioiodine ablation (follow-up group) compared to the ablation group, in patients with~     low-risk differentiated thyroid cancer treated with total thyroidectomy with or without lymph~     node dissection (pT1am N0 or Nx, pT1b N0 or Nx)~   "
132141|NCT01837732|"~     The aim is to investigate the feasibility and efficacy of a relational touch / relational~     intervention on persistent pain in a long term geriatric hospital care ward population. The~     main issue is the pain reduction. The hypothesis is that this type of intervention is very~     useful on pain reduction in old people even with physical or mental disability.~   "
132142|NCT01837719|"~     The purpose of the study is to compare the pharmacokinetics and bioequivalence of atazanavir~     in a fixed-dose combination with cobicistat with that of atazanavir coadministered with~     cobicistat as single agents.~   "
132143|NCT01837706|"~     The purpose of this study is to observe whether people would report being less likely to sue~     a physician who shows more empathy when giving a patient potentially bad news regarding their~     medical condition.~   "
132144|NCT01837693|"~     In industrialized countries, cervical cancer is a well controlled disease thanks to the~     diffusion of Pap test and, in particular, to organized screening programs, which are able to~     detect and treat pre-invasive lesions (cervical intraepithelial neoplasia, CIN). The human~     papilloma virus (HPV) has been recognised as the necessary, but not sufficient, cause of~     cervical cancer, so a new screening test based on the identification of high risk (HR) HPV~     types has been developed(HPV DNA test). This test has demonstrated to be more effective than~     cytology in reducing the incidence and the mortality of cervical cancer, but it is less~     specific, so the use of a test triage is necessary to reduce the number of colposcopies and~     the risk of over-diagnosis (due to the potential regressivity of pre-invasive lesions). Until~     now, the triage test used is the cytology (Pap test).~      Recently specific biomarkers (mRNA and p16 tests) have been introduced for high grade CIN,~     targeting the molecular alterations strictly associated to transformation rather than simply~     detecting HR-HPV infections. These tests are more specific than HPV DNA test with a modest~     reduction of sensitivity for high-grade lesions.~      This is a multicenter randomised trial nested into some Italian screening programs based on~     the use of HPV DNA test as primary test.~      All women with positive HPV DNA test will be tested for cytology and also for mRNA and p16.~     Women with positive cytology will be referred to colposcopy, while women with negative~     cytology will be randomized into two arms.~      This study aims to evaluate if mRNA and p16 could be used as test of triage of HPV DNA or as~     a primary screening test with direct sending in colposcopy.~      In particular the main objectives are:~        -  Measuring the cumulative detection rate of CIN2+ in the five years following a HPV DNA~          positive test and mRNA or p16 negative.~        -  Measuring the potential reduction of overdiagnosis of using mRNA or p16 test instead of~          DNA, with direct sending in colposcopy~        -  Measuring the reduction of overdiagnosis of cytological triage or triage with mRNA or~          p16 compared to the direct sending in colposcopy in women with HPV DNA test positive.~      Secondary objectives are:~        -  to assess the feasibility of mRNA testing in primary screening~        -  to validate the sample techniques for the new tests~        -  to standardize quality controls for the the new tests~   "
132145|NCT01837680|"~     The aim of this study is to compare glycemic control in pregnant women treated with insulin~     Detemir and pregnant women treated with NPH insulin. These women are diagnosed with~     gestational diabetes (GDM) in the current pregnancy or have a preexisting diagnosis of type 2~     diabetes (T2DM) at the onset of pregnancy. Our hypothesis is that there is no difference~     between these two treatment modalities in terms of glycemic control in diabetes.~   "
132147|NCT01837654|"~     The purpose of this study is to find out whether plantarflexion has an effect on the degree~     of urinary urgency and on the amplitude of detrusor contraction during filling cystometry in~     patients with detrusor overactivity (DO).~   "
132301|NCT01835613|"~     The purpose of this study is to assess the clinical response to IL-6 inhibition defined as~     Low Disease Activity (DAS44) <2.4) at the follow-up visit at 12 months and the correlation~     between the biomarkers and treatment response.~   "
132148|NCT01837641|"~     The study will evaluate the safety of LY3002813 by looking at adverse events. The study will~     also look at the effect the body has on LY3002813. Study participants will be healthy or will~     have mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild to moderate AD.~      There will be seven groups of study participants. Five groups will receive a single dose of~     LY3002813 or placebo (no drug), followed by up to 4 multiple doses of LY3002813 or placebo~     given as an injection into a vein. Approximately 12 weeks will pass between the single dose~     and the first multiple dose. One group of participants will receive a single dose of~     LY3002813 given as an injection under the skin. One group of participants will receive a~     single dose of LY3002813 given as an injection into a vein.~   "
132149|NCT01837628|"~     Our purpose is to compare between intraurethral lidocaine gel and paraffin oil in reducing~     urethral pain during urodynamic test.~   "
132150|NCT01837615|"~     Low Level Light therapy (LLLT) has been used for tissue healing in many mucosal diseases that~     involve wounds, ulcers and inflammation, oral chemotherapy-induced mucositis in particular.~     Likewise IBD is characterized by chronic tissue inflammation, tissue damage and ulcerations~     in various extents. Therefore we hypothesize that LLLT might be effective in treating IBD and~     the Photopill capsule was developed for this purpose.~      An open-label, interventional, clinical trial was designed for assessment of the safety and~     feasibilty of the Photopill capsule treatment in patients with mild to moderate Ulcerative~     Proctitis.~      Primary endpoints being: safety reflected by the number and severity of adverse events and~     mucosal appearance at sigmoidoscopies day 14, day 28, day 42 compared to baseline condition.~      Furthermore clinical and biochemical parameters are monitored during the study.~   "
132151|NCT01837602|"~     An open-label, clinical trial of autologous cMet redirected T cells administered~     intratumorally (IT) in patients with breast cancer. Fifteen evaluable patients will be~     enrolled in stepwise fashion. Step 1 will enroll patients with metastatic breast cancer~     refractory to at least 1 standard therapy, step 2 will include newly diagnosed patients with~     operable triple negative breast cancer.~   "
132152|NCT01837589|"~     The purpose of this study is to conduct a comparative study for the study of bone~     mineralization evaluated with Quantitative computed tomodensitometry (QCT) compared to the~     reference technique, Dual-emission X-ray absorptiometry (DXA).~   "
132153|NCT01837576|"~     The purpose of this study is to evaluate the antipsoriatic effect of 5 different combinations~     of calcipotriol plus betamethasone dipropionate in Daivobet® gel vehicle in compared to~     Daivobet® gel in order to explore/find other safe and effective combination of the two~     components.~   "
132154|NCT01837563|"~     The purpose of this study is to determine whether four new alternative imaging methods can be~     used to follow the response of breast cancer to the treatment patients are being given. These~     methods produce an image of the inside of the breast so that doctors can better decide~     whether breast cancer is responding to therapy. An important part of the study is to examine~     the same person with all methods in order to directly compare results. The four methods are:~     MRI Elasticity Imaging (abbreviated MRE), Electrical Impedance Spectroscopy (abbreviated~     EIS), Microwave Imaging and Spectroscopy (abbreviated MIS), Near Infrared Spectroscopy~     (abbreviated NIR). In addition to the experimental imaging methods, patients may also undergo~     a contrast-enhanced MRI, and/or additional mammography, which will help researchers compare~     the experimental methods. These additional examinations are accepted diagnostic procedures;~     they are not experimental. Some participants will have one or both of these additional~     examinations if clinically indicated.~   "
132155|NCT01837550|"~     The purpose of this study is to examine the short-term effects of complementing an~     educational program for hearing aid users with Internet support.~   "
132156|NCT01837537|"~     The purpose of this study is to meet the respiration rate accuracy specifications for the~     study pulse oximeter monitoring system (study device) in a hospitalized volunteer population~     when compared to established technologies for measuring parameters related to respiration,~     such as Capnograph Respiration Rate (RR)(CO2).~   "
132157|NCT01837524|"~     Randomized trial of grocery-store based nutrition counseling visits for weight management vs.~     in-office visits. The investigators will test pre- and post-intervention individual-level~     dietary quality, knowledge, self-efficacy around dietary choice, and cost of shopping,~     measuring difference between intervention and control arms. At the study's end, the~     investigators will also conduct focus groups with a subset of 20 patients (10 from each arm)~     and do a structured interview with the dietitian to better understand the feasibility,~     strengths and shortcomings of this approach. Patients who complete the main portion of the~     trial will be randomly selected for recruitment into a focus group and consented separately~     for that focus group at the end of the study.~      The investigators hypothesize that, compared to office-based visits, the KP Personal Shopper~     visits will result in higher member diet quality scores, better nutritional knowledge scores,~     higher self-efficacy and confidence around food purchasing decisions, and more favorable~     perception of the visit by both dietician and member. The KP Personal Shopper approach may~     also result in increased grocery store costs for some members. Long-term, the investigators~     hypothesize that improvements in member perception, knowledge and dietary quality will lead~     to improved health outcomes.~   "
132158|NCT01837511|"~     This study aims to investigate the expression of Melanoma-associated antigen 3 (MAGE-A3),~     Melanoma-associated antigen C2 (MAGE-C2), New York esophageal squamous cell carcinoma 1~     (NY-ESO-1), L antigen family member 1 (LAGE-1), Wilms' tumor gene (WT1) and PRAME~     (PReferentially expressed Antigen of MElanoma) tumor antigens in a large number of~     pathologically proven stage I, II and III NSCLC samples of Asiatic patients.~   "
132170|NCT01837355|"~     Pulmonary inflammation is an independent risk factor for disease progression in cystic~     fibrosis patients (CF). Yet, no effective treatment is known to reduce this detrimental~     inflammation. Dysbiosis of the gut microbiota has been linked to inflammation in several~     inflammatory diseases. As children with CF have different faecal microbiota from their~     healthy siblings, modulating gut microbiota by lactobacillus rhamnosus diet supplementation~     might be a strategy to target the inflammatory state in CF. Study subjects (CF or healthy~     control) will receive either placebo or lactobacillus rhamnosus once daily as dietary~     supplementation for 12 weeks. After a one-week washout phase, they will be switched for~     another 12 weeks to the other trial arm. Effect on in intestinal and pulmonary inflammation~     as well as clinical outcome will be studied.~   "
132159|NCT01837498|"~     The majority of patients undergoing surgery receive neuromuscular blocking agents (NMBAs) in~     the operating room. Reversal of neuromuscular blockade at the conclusion of a general~     anesthetic is accomplished with cholinesterase inhibitors (primarily neostigmine). Although~     these drugs are often effective in enhancing recovery of muscle strength, the onset of effect~     is often slow (usually 15-30 minutes). More effective neuromuscular reversal agents are~     needed in clinical practice to enhance surgical and anesthetic management of perioperative~     patients. A new reversal agent (sugammadex) will likely be approved for clinical use in the~     United States next year. Unlike neostigmine, sugammadex is effective in providing rapid~     antagonism of all levels of neuromuscular blockade (typically within 2-4 minutes). The aim of~     this prospective observational study is to study neuromuscular and clinical recovery in 120~     consecutive thoracic surgical patients receiving neostigmine, followed by a 120 consecutive~     thoracic surgical patients administered sugammadex (after the drug is approved by the FDA).~     In addition, after data on 120 patients reversed with neostigmine is collected, the data will~     be analyzed to compare patients with residual block (train-of four < 0.9) and without~     residual block (TOF </= 0.9)~   "
132160|NCT01837485|"~     Some evidences have shown that probiotics are effective in the treatment of irritable bowel~     syndrome. Because few evidences are available in our population, we investigated if~     probiotics are effective in our patients as well. We hypothesize that the probiotic Lactol~     which contains Lactobacillus Sporogenes reduces the symptoms of irritable bowel syndrome.~   "
132161|NCT01837472|"~     Evidence have shown benefits of gut flora modulation in treatment of irritable bowel syndrome~     (IBS), but few reports are available on the effects of multistrain probiotics and there are~     few reports available in this regard from our society. Thus, we investigated if probiotics~     are effective in our patients as well. We hypothesize that the multistrain probiotic Balance~     containing seven bacteria species including Lactobacillus strains, Bifidobacterium strains,~     and Streptococcus thermophiles reduces the symptoms of irritable bowel syndrome.~   "
132162|NCT01837459|"~     In this research study the investigators want to learn more about the risk of developing~     blood vessel and heart disease from night-time sleep apnea. Sleep apnea is a condition that~     results from blocking of the throat during sleep. This study examines changes in blood~     pressure, blood vessel stiffness, heart size and levels of specific substances in the blood~     which may cause heart disease.~      This study is for children ages 5 to 13 years. The study involves 3 visits over 18 months.~     The first and last visits include an overnight sleep study (polysomnography or PSG). All the~     visits will include:~        -  body measurements to measure growth and how weight is distributed,~        -  resting blood pressure measurements,~        -  heart measurements (electrocardiogram and ultrasounds of the heart and blood vessels),~        -  36 hour home ambulatory blood pressure measurements,~        -  blood tests to look at things like fats, cholesterol, inflammatory factors,~        -  questionnaires~      Optional parts of the study include DNA and for children 8 years and older, testing and~     questionnaires to learn more about how sleep relates to learning, memory and behavior issues.~   "
132163|NCT01837446|"~     Oral mucositis is a debilitating side effects of cancer treatment for which there is not much~     successful treatments at yet. The investigators are going to evaluate the effectiveness of~     topical morphine compared with a routine mouthwash in managing cancer treatment-induced~     mucositis. The investigators hypothesize that topical morphine is more effective and more~     satisfied by patients than the magic mouthwash in reducing severity of cancer~     treatment-induced oral mucositis.~   "
132164|NCT01837433|"~     Efficiency and Safety Study of Short-term Prednisone to Treat Moderate and Severe Subacute~     Thyroiditis~      The investigators hypothesize that less adverse reactions will be observed, comparing with~     the guidelines recommend. The recurrence rate, adrenal insufficiency, temporary and permanent~     hypothyroidism aren't significant difference.~   "
132165|NCT01837420|"~     This study will examine the safety and efficacy in subjects with moderate to severe~     psoriasis, as measured by Psoriasis Area and Severity Index(PASI), Body Surface Area (BSA),~     Dermatology Life Quality Index (DLQI) and other assessments.~   "
132166|NCT01837407|"~     Complex digital injuries involving soft tissue loss and digital nerve defect pose challenging~     problems for hand surgeons. This study uses the heterodigital arterialized nerve pedicle flap~     including the dorsal branch of the digital nerve for reconstructing a digital neurocutaneous~     defect of the proximal phalanx.~   "
132167|NCT01837394|"~     In this study, we wish to investigate the effect of ultrasound (US) -guided block of the~     saphenous nerve (SN) and the posterior branch of the obturator nerve (ONP) on postoperative~     pain and the use of opioids (morphine-like pain medicine) in the first 24 hours following~     ambulatory knee arthroscopy.~      We wish to investigate the analgesic effect of these two blocks compared to placebo~     (injection of local anesthetic with known pain blocking properties compared with injection of~     a saline solution), when used as a supplement to conventional oral analgesics.~      We hypothesize that patients receiving the active treatment may experience less pain during~     the first 24 hours after their operation than patients receiving the placebo treatment, and~     possibly require less opioid analgesics, experience less opioid related side effects and have~     a higher function level in this period than patients receiving the placebo treatment.~   "
132168|NCT01837381|"~     The objective of this trial was to evaluate the clinical outcome, treatment toxicity and~     tumor response of TEA for unresectable HCC.~   "
132169|NCT01837368|"~     Validation of PRISM (Pictorial Representation of Illness and Self Measure) as a assessment of~     quality of life and suffering in patients with tinnitus.~      Association between experiencing, verbalizing and regulating emotions and perceived tinnitus.~      Correlation analysis are used to search for connections between the subjective behavioral~     outcomes mentioned above and the objective EEG-patterns.~   "
132179|NCT01837238|"~     The purpose of this study is to examine the effect of 6 months of daily beta-hydroxy~     beta-methylbutyrate (HMB) supplementation on the physical function and the health of bones,~     arteries and heart in hemodialysis patients.~   "
132302|NCT01835600|"~     For some upper ureteral and renal stones,ureteroscopic lithotripsy needs to be performed~     under general anesthesia with interrupted suspension of mechanical ventilation, which could~     result in hypercapnia and hypoxia. In this study, the investigators hypothesize that 10 cmH2O~     PEEP added to the respiratory circuit with 1 L/min 100% oxygen might extend the time of~     ventilation suspension but have no effect on carbon dioxide retention in blood.~   "
132171|NCT01837342|"~     Sigmoid diverticular diseases is a pathologie frequent in patients above 60 years old. A~     person with diverticulosis may have few or no symptoms. When a diverticulum ruptures and~     infection sets in around the diverticulum the condition is called diverticulitis. An~     individual suffering from diverticulitis may have abdominal pain, abdominal tenderness, and~     fever. Bleeding originates from a diverticulum, it is called diverticular bleeding. Frequent~     hospitalisations as a result of the evolution of purulent peritonitis that originates from~     diverticulitis treated by mini-invasive surgery results.~      Radiological percutaneous drainage and washing of the abdominal cavity during laparoscopic~     generalized purulent peritonitis of diverticular origin have been identified as therapeutic~     options by HAS (French health authorities), followed by second stage resection-anastomosis~     under elective surgery. It has been observed in patients that if only drainage and washing~     are performed (without resection), then the morbidity (10%) and mortality (1.5%) rates are~     much lower than usual rates (after resection) respectively 20-40% and 10-30%. Furthermore~     this reduces the risks of postoperatory complications.~      Some studies have shown that the attitude of non-distance resection of the acute episode was~     associated with a recurrence rate of diverticulitis less than 5% recurrence without gravity.~     In addition, the morbidity associated with intervention sigmoid resection is around 30%.~      The question arises in our daily practice, or not to propose systematic resection of sigmoid~     diverticulitis after an acute episode of severe purulent peritonitis or abscess types~     supported initially by minimally invasive.~      The primary objective of the study is to determine, after clinical improvement linked to~     conservative treatment of perforated diverticulitis Hinchey peritonitis stage II and III, if~     a conservative approach reduces morbidity compared with a cold sigmoid resection attitude as~     currently recommended.~      The secondary objective of the study is to determine if conservative treatment reduces~     mortality, length of hospital stay compared with cumulative sigmoid diverticular disease and~     improves quality of life.~   "
132172|NCT01837329|"~     The main objective of this study is to determine recommended phase II dose and safety of~     tetrathiomolybdate (TM) in combination with carboplatin and pemetrexed in chemo-naive~     metastatic or recurrent non-squamous non-small cell lung cancer.~   "
132173|NCT01837316|"~     The study will be a randomized, double-blind, placebo controlled cross-over study in 32 adult~     subjects with moderately severe asthma. In this study the bronchodilator effect of a single~     morning dosing of FF/VI combination 100/25 mcg will be determined by spirometry. After the~     screening the subject will be randomized and will be assigned to one of two treatment~     sequences (AB or BA, where A is placebo and B is FF/VI 100/25 mcg). Between the two treatment~     periods there will be a washout period of 7-14 days. A serial forced expiratory volume in one~     second (FEV1) measurements will be taken at 15, 30 minutes, 1, 2, 4, 12, 24, 36, 48, 60 and~     72 hours post dose. Safety assessments will include vital signs, electrocardiograms (ECGs),~     adverse event (AE) monitoring and laboratory safety tests however, these will not constitute~     study endpoints. The results of the study will provide supporting information to prescribers~     on the bronchodilator effect of FF/VI over 72 hours.~   "
132174|NCT01837303|"~     Purpose: To assess equivalence between low cost manual liquid based cytology (pap smear) and~     standard Thin prep cytology screening.~      Participants: 100-120 healthy women presenting for standard pap smear screening~      Procedures (methods): After routine care pap smear, another pap smear will be performed and~     placed in the study medium. Clinical care pap and study pap will be reviewed by a single~     pathologist to assess for equivalent findings.~      Hypothesis: Manual liquid based cytology is equivalent to conventional liquid based cytology.~   "
132175|NCT01837290|"~     Geriatric patients (age ≥ 65 years) undergo surgery for hip fractures that develops due to~     osteoporosis and falls. Dialysis-dependent chronic kidney disease is associated with an~     increased risk of cardiovascular comorbidity. Elective or urgent surgical operations may be~     required for geriatric patients with end stage renal disease. These patients have severe~     comorbidities, fluid, electrolyte disturbances and drug metabolism abnormalities during the~     perioperative period. For this reasons a careful anesthesia plan should be planned and~     performed. Spinal anesthesia can be used for hip fracture surgery at geriatric patients with~     chronic renal failure. Anterograde femoral intramedullary nailing can be performed in supine~     position with a fracture table. Intraoperative sedation might be necessary for patients under~     regional anesthesia on traction table. Dexmedetomidine is an alpha 2 receptor agonist that is~     being used as an agent for its sedative and adjuvant analgesic effects.~      The aim of this study is to evaluate the effects of dexmedetomidine premedication on~     geriatric patients with end stage renal disease, who will be undergoing a surgical operation~     for hip fracture under spinal anesthesia with hyperbaric bupivacaine and BIS (Bispectral~     Index) guided sedation with intraoperative propofol infusion.~   "
132176|NCT01837277|"~     The current available antiretroviral (ARV) agents make possible a successful treatment of~     virtually all HIV-infected patients, but some problems related to early mortality are still~     of concern, mainly in resources-limited settings. There are several published reports showing~     that such patients are at a significantly higher risk of death during the first months of~     treatment, in comparison with the observed outcomes in developed countries. One of the~     consistently detected risks for early mortality across these reports is the baseline low CD4~     count, although it does not seem to be the only reason for such outcome. In Brazil and other~     developing countries, there is still a large proportion of AIDS patients who are diagnosed~     with AIDS, or only seek health care for HIV infection late in the course of disease.~     Raltegravir (RAL), the first HIV-1 integrase inhibitor, is a potent and safe ARV drug. The~     available evidence suggest it promotes a faster decline in HIV-1 plasma viremia, and a higher~     increase in CD4 cells count, in comparison with those in Efavirenz (EFV) arm. The~     investigators propose to compare the impact of RAL versus EFV in the early mortality rates~     for severely ill (CD4+ cells count <50 cells/mm3) patients starting ARV therapy.~   "
132177|NCT01837264|"~     Compartment syndrome (CS) is a condition resulting from increased pressure within a~     compartment, which compromises circulation and can lead to critical limb ischemia. CS is one~     of the biggest medical challenges that our soldiers face after battlefield related injuries.~     Chronic or exercise-induced compartment syndrome (CS)rarely requires treatment; acute~     compartment syndrome is a medical emergency requiring surgery. Treatment of compartment~     syndrome is limited to fasciotomy, which relieves the pressure.The study purpose is to~     evaluate the feasibility and safety of the administration of marrow-derived autologous bone~     marrow concentrate and PRP gel generated by a point of care marrow separation system for the~     treatment of compartment syndrome. And to show this treatment possibly enhances wound~     healing, bone healing, perfusion, infection control, and the return of limb function in~     patients with CS.~      Stem Cell and regenerative medicine development efforts for therapeutic angiogenesis and~     wound healing have predominantly focused on the mechanism of action of a single stem cell~     population to achieve neovascularization and improve tissue perfusion. It is well documented~     that other cells, including platelets, are efficient carriers of growth factors (VEGF-PDGF,~     bFGF, and SDF-1) and play active roles in angiogenesis and wound healing. Arteriocyte's~     development efforts focus on concentration of autologous bone marrow-derived stem cells and~     platelets for delivery to the site of injury in a concentration sufficient to effect local~     tissue revascularization and repair. These products provide for the rapid, bedside~     preparation of autologous PRP and bone marrow stem cell concentrate.~      This clinical trial with the Magellan® System is for the preparation of autologous cell~     concentrate for the treatment of wound, tissue and bone healing, improved perfusion,~     infection control, and the return of limb function in patients at risk of amputation.~   "
132178|NCT01837251|"~     Evaluation of the best therapeutic index for patients with platinum-sensitive ovarian cancer~     when treatment with bevacizumab and gemcitabine/carboplatin or with bevacizumab and~     PLD/carboplatin.~   "
132180|NCT01837225|"~     Breast cancer is the most commonly occurring cancer in women. Currently, breast conservation~     surgery (BCS) is the treatment most often prescribed. BCS involves removing the tumor while~     conserving the greatest amount of healthy breast tissue. Under standard white light, tumor~     borders are difficult for the surgeons to visualize. Therefore, between 30-70% of patients~     require a second operation to remove remaining cancerous tissue that wasn't detected during~     the initial surgery. Thus, there is an urgent clinical need for a new imaging tool that~     improves tumor visualization during the first surgery.~      PRODIGI, a new hand-held optical imaging device, uses a safe violet-blue light to detect~     fluorescence signals in the tissue. Different tissues are associated with specific~     fluorescent colors and therefore the device can be used to differentiate between tumor and~     healthy breast tissue. Based on previous clinical data, PRODIGI can distinguish some tumors~     from normal tissues, but is not specific enough to detect a difference across all breast~     tumor types.~      The fluorescent contrast drug 5-aminolevulinic acid (5-ALA) accumulates in tumors naturally~     and previous research has shown that 5-ALA increases tumor-normal tissue fluorescence~     contrast. In this observational clinical study, PRODIGI and 5-ALA will be used to visualize~     tumor borders during BCS. 5-ALA induced fluorescent images from the surgical sample and the~     surgical bed obtained by PRODIGI will be compared retrospectively with the images taken under~     standard white light and/or autofluorescence. The technology's ability to accurately identify~     tumor borders better than conventional practice will be confirmed by tissue pathology.~   "
132181|NCT01837199|"~     Randomized controlled clinical trials have demonstrated that the use of amoxicillin (AMX) and~     metronidazole (MTZ) as adjuncts to mechanical therapy improves the clinical and~     microbiological outcomes of scaling and root planing (SRP) in non-smokers and smokers with~     ChP. However, the effects of this antibiotic protocol have not been directly compared in~     non-smokers and smokers. Therefore, the aim of this study will be to compare the clinical and~     microbiological effects of the adjunctive use of MTZ+AMX to SRP in smokers and non-smokers~     subjects with chronic periodontitis (ChP). It was hypothesized that non-smokers would benefit~     better from this combination of therapies than the smokers.~   "
132182|NCT01837186|"~     Empyema following pneumonectomy for Non Small Cell Lung Cancer (NSCLC) is a known problem~     that occurs in about 2% of pneumonectomy patients.~   "
132183|NCT01837173|"~     It is well known that lymph node metastasis is one of the most important prognostic factors~     in oesophageal carcinoma.~      The investigators want to determine the influence of lymph node characteristics, being either~     intracapsular or extracapsular, on overall survival after esophagectomy for esophageal~     cancer.~   "
132184|NCT01837160|"~     Angiogenesis and fibrosis lie at the heart of a number of fundamental processes responsible~     for cardiovascular disease. In this proposal, the investigators intend to build upon a highly~     successful programme of studies exploring the cardiovascular applications of positron~     emission tomography. Specifically, the investigators will explore the potential role of a~     novel radiotracer, 18F-fluciclatide, which is a highly selective ligand for the αvβ3 and αvβ5~     integrin receptors that are up regulated during angiogenesis, and tissue fibrosis and~     remodelling. This tracer has been successfully used to assess angiogenesis in metastatic~     tumours and its uptake is suppressed by anti-angiogenic therapies. The investigators here~     propose to describe the pattern of uptake of 18F-fluciclatide in cardiovascular diseases,~     specifically aortic stenosis and aortic atherosclerosis. The investigators will correlate~     18F-fluciclatide uptake with in vivo measures of angiogenesis and fibrosis as well as ex vivo~     histological characterisation of tissue. If successful, this novel radiotracer could provide~     an extremely important non-invasive method of assessing in vivo angiogenesis, plaque~     vulnerability, and tissue remodelling as well as potential applications in developing stem~     cell therapies.~   "
132185|NCT01837147|"~     Women who are overweight or do not exercise are at higher risk for breast cancer after~     menopause. This study will test a new electronic device that measures the body's movement and~     works alongside a website to help women increase their physical activity level. If effective,~     this system could be tested in larger studies aiming to reduce breast cancer risk by reducing~     or preventing obesity.~   "
132186|NCT01837134|"~     Lifestyle changes often fail due to loss of motivation. Telemedicine and personal coaching~     have the potential to support lifestyle change and weight loss. Therefore, the aim of our~     randomized controlled trial is to examine the effect of telemedicine with and without~     coaching in comparison to a control group on weight loss in overweight participants.~   "
132187|NCT01837121|"~     The purpose of this study is to use a randomized controlled design to determine the impact of~     a SMS messaging intervention on the following outcomes among persons diagnosed with diabetic~     retinopathy in rural China.~   "
132188|NCT01837108|"~     Various studies have reported cardioprotective effects of mineralocorticoid receptor (MR)~     antagonists in the setting of an acute myocardial infarction. In a recent animal study, the~     protective effect of MR antagonists on infarct size was completely abolished in CD73~     knock-out and adenosine A2b receptor knock-out mice, and by co-administration of adenosine~     receptor antagonists in rats. These findings suggest that extracellular formation of~     adenosine is crucial for this protective effect and that MR antagonists stimulate~     extracellular adenosine formation by the enzyme CD73.~      To investigate whether eplerenone promotes adenosine receptor stimulation by activating CD73,~     the investigators will measure forearm blood flow in response to various dosages of~     dipyridamole with the use of plethysmography. Dipyridamole increases the extracellular~     endogenous adenosine concentration by inhibition of the ENT transporter and induces local~     vasodilation. Therefore, the vasodilator effect of dipyridamole accurately reflects~     extracellular adenosine formation by the CD73 enzyme.~   "
132189|NCT01837095|"~     POL6326 will be given by i.v. infusion over 2 hours. Treatment will occur on days prior to,~     on the day of and on days after treatment with eribulin. Different doses and dosing~     frequencies will be investigated~   "
132190|NCT01837082|"~     The hypothesis to be tested is whether treatment with intravenous iron (ferric~     carboxymaltose) will improve left-ventricular ejection fraction in patients with heart~     failure and iron deficiency as determined by cardiac magnetic resonance imaging.~   "
132191|NCT01837069|"~     This trial is designed to determine the best preoperative management strategy for patients~     undergoing orthopedic surgery.~   "
132193|NCT01837043|"~     The purpose of this study is to evaluate the safety and efficacy of conversion from a~     calcineurin inhibitor (tacrolimus or cyclosporine) immunosuppression therapy to Nulojix®~     (belatacept) immunosuppression therapy in patients with delayed (DGF) or slow graft function~     (SGF) following kidney transplantation. Patients at risk for SGF or DGF will be consented at~     the time of kidney transplantation. On post-op Day 5 the patient will be assessed, if they~     have developed SGF or DGF they will be randomized to convert to Belatacept or continue on~     their CNI regimen. Up to 20 subjects who do not develop DGF will be followed as control~     subjects. Seventy randomized subjects will be followed for a total of 14 months with a renal~     biopsy at Month 12 post transplant.~      Research Hypotheses:~      Primary Hypotheses:~        -  Kidneys with slow or delayed graft function are more susceptible to acute and long-term~          CNI toxicity~        -  Kidneys converted from calcineurin inhibitor based therapy to belatacept will achieve a~          more rapid recovery from post-ischemic acute tubular necrosis (ATN) and will have~          improved 1 year calculated GFR.~      Key Secondary Hypotheses:~        -  Renal Histology: Belatacept converted patients will have a lower chronic allograft~          damage index (CADI) score and lower interstitial fibrosis and tubular atrophy (IF/TA)~          score as calculated by Banff criteria at 1 year post- transplant~        -  Biomarker Analysis: Biomarker analysis (clusterin) measured in serial urine collections~          can 1) directly assess CNI induced kidney injury and 2) improve the prediction of~          patients that benefit in early belatacept conversion.~   "
132194|NCT01837030|"~     This study is a single center prospective randomized control trial comparing the utility of~     performing capsule endoscopy compared to conservative management with oral iron therapy as~     the initial course of action in patients with non-severe obscure occult or obscure overt~     gastrointestinal (GI) bleeding. The investigators hypothesize that outcomes in patients with~     non-severe obscure GI bleeding who receive conservative therapy with oral iron will not~     differ to those on oral iron who undergo capsule endoscopy.~   "
132195|NCT01837017|"~     Over half of persons with multiple sclerosis (MS) report falling over a 6-month period and a~     majority of those who fall require medical attention for injuries. Importantly, balance~     dysfunction, muscle weakness, and spasticity are modifiable risk factors for falls among~     community-dwelling older adults and likely persons with MS. Indeed, there is evidence that~     these physiological risk factors can be minimized with exercise training in persons with MS~     and this might translate into a decrease in fall risk as documented in community-dwelling~     older adults.~      The investigation will examine the effectiveness of a home-based exercise program that is~     designed to reduce fall risk by targeting specific fall risk factors including balance~     dysfunction and two of its latent causes, muscle weakness and spasticity in persons with~     multiple sclerosis. It is predicted that persons who receive home-based exercise program will~     have a reduction in fall risk.~   "
132196|NCT01837004|"~     The purpose of this study is to compare CORTEX (Cognitive Regulation Training and Exercise),~     a multi-faceted, general and exercise-specific cognitive training program plus a 4-month~     exercise program, to an attention-control condition involving health and wellness~     informational lectures plus videos. The proposed exercise program will involve both aerobic~     and resistive exercises. The investigators hypothesize that pre-intervention cognitive~     training will enhance self-regulation and self-efficacy and in turn, increase exercise~     adherence. The investigators also expect more positive improvements in cognitive and~     psychosocial function among participants in the CORTEX condition as compared to the Control~     condition immediately following the cognitive booster training, and across time.~   "
132197|NCT01836991|"~     The purpose of this study is to evaluate the safety and the effect of D2 and D2+ radical~     surgery for the treatment of advanced distal gastric cancer.~   "
132198|NCT01836978|"~     The process of enhancing the functional capacity of an individual before an operation to~     enable him or her to withstand the stress of surgery has been termed prehabilitation. It has~     been shown that poor baseline capacity for physical performance and poor nutritional status~     increase the risk of complications after major non cardiac surgery and prolong recovery. A~     controlled randomized study in patients undergoing radical cystectomy for cancer is therefore~     proposed to determine the impact of multimodal prehabilitation on functional exercise~     capacity and functional recovery. Patients who accept to be enrolled in the study will be~     randomized to either a group receiving a multimodal intervention which includes nutritional~     supplementation (Immunocal® whey protein) combined with a physical exercise program and~     stress reduction strategies before and after surgery, or a control group who will receive~     standard preoperative treatment as per our institution.~   "
132199|NCT01836965|"~     The objective of this study is to validate a social skills training program manual for~     adolescents (ages 13-17) with Asperger's Syndrome or high functioning autism. Approximately~     150 adolescents with autism spectrum disorders will participate in this study, in groups~     consisting of 6 adolescents and 6 peer volunteers. Participants will participate in both~     group therapy and peer generalization sessions (in the form of a photography class) once a~     week over the course of twelve weeks. Participants and their parents will complete paper and~     pencil, online, or phone measures and video-recordings to assess the participant's social~     skills prior to the intervention, at completion of the intervention and three months later.~   "
132200|NCT01836952|"~     Dietary and oral hygiene habits are known to affect oral microorganisms and disease~     incidence, but most research has focused on preschool aged (2-4 yr old) children. A recent~     experiment in our lab demonstrated a highly diverse oral microbiome in the saliva of infants~     without teeth (3-6 months old). These data suggest that soft tissues in the mouth serve as a~     reservoir for pathogens and must be considered in oral health management. The evolution of~     microorganisms that occurs between birth and tooth eruption has not been characterized and~     may have great implications as it pertains to oral disease later in life. The investigators~     are interested in determining how dietary changes during this time affect oral microbiota.~     Tongue and cheek swab samples will be collected from a small cohort of infants (n=20) at 4~     time points. At the same time, a survey and 3 day feeding diary of the infant's diet will be~     collected. In addition, a pregnancy survey and food frequency questionnaire will be~     administered at the time of recruitment. Research staff will conduct a 10-minute interview at~     the first and last oral sample collection time. These pilot data will provide important~     diet-oral microbe relationships in edentulous infants, allowing us to propose and test~     specific hypotheses pertaining to diet, oral microbes, and disease in young children.~   "
132203|NCT01836913|"~     The RESPECT study is intended to prospectively assess the impact of PET/CT on the delineation~     of target volumes and to estimate the proportion of recurrences that could possibly be~     prevented by the use of PET/CT-based target volume, instead of CT-based. Patients will~     recieve radiotherapy using CT-based planning, but a PET/CT-based treatment plan will also be~     made. CT-based and PET/CT-based target volumes will be compared after treatment has been~     completed. If a locoregional recurrence takes place, the localisation will be compared to the~     CT-based and PET/CT based clinical target volumes (CTVs). If the local recurrence is located~     outside the CT-CTV but inside the PET/CT-CTV, the recurrence could possibly have been~     prevented with PET/CT-based radiotherapy.~   "
132204|NCT01836900|"~     Prospective-randomized trial. Patients with recurrent bleeding from gastroduodenal ulcers are~     randomized into either endoscopic treatment with the OTSC [Over The Scope Clip] or endoscopic~     standard therapy. Hypothesis: Endoscopic therapy with OTSC is superior to standard therapy~     regarding technical success and rebleeding.~   "
132205|NCT01836887|"~     The purpose of this study is to determine whether consumption of the active product affects~     postprandial changes in metabolic indices, in comparison to the control product.~   "
132206|NCT01836874|"~     The purpose of this study is to evaluate the safety and effectiveness of topiramate in~     preventing migraine among Indian participants requiring prophylaxis (measure taken to~     maintain health and prevent the spread of disease).~   "
132207|NCT01836861|"~     This is an open-label, 2-period, absorption, distribution, metabolism and excretion (ADME)~     and absolute bioavailability study in 6 healthy adult male subjects.~   "
132208|NCT01836848|"~     The purpose of this study is to show if it is possible to detect secondary ischemic events in~     patients with severe brain injury or cerebral haemorrhage with the help of non-invasive~     near-infrared spectroscopy (NIRS) by using the indocyanine green measuring of cerebral~     perfusion.~   "
132209|NCT01836835|"~     Nausea in early pregnancy (emesis gravidarum) is very common but most often self-limiting.~     Hyperemesis gravidarum; where nausea and vomiting is severe and protracted is potentially~     dangerous for the woman and her foetus and necessitates hospital treatment. An English~     questionnaire (PUQE; Pregnancy Unique Questionnaire of Emesis) exists that can differentiate~     between uncomplicated emesis and the severe hyperemesis condition. This questionnaire has~     been translated to Norwegian. The investigators want to test the ability of this~     questionnaire to differentiate the grade of nausea/vomiting between a group of presumed~     normal pregnant woman and patients treated for hyperemesis gravidarum in a Norwegian~     population. The investigators also want to relate the PUQE questionnaire scoring to the~     women/patients' self-reported nutritional intake during 24 hours.~   "
132210|NCT01836822|"~     The development of endobronchial ultrasound (EBUS) and EBUS-guided transbronchial needle~     aspiration (EBUS-TBNA) has improved the safety and diagnostic accuracy of the mediastinal~     lymph node (MLN) sampling. Still, in some diseases routine cytological specimens are~     considered insufficient and histological sampling is preferred. The aim of the study is to~     compare the diagnostic accuracy of EBUS-TBNA and two other, more invasive procedures to~     obtain histological samples from MLN in patients with clinical and radiological features of~     sarcoidosis.~      Bronchoscopy with bronchoalveolar lavage (BAL), EBUS-TBNA, EBUS guided transbronchial forceps~     biopsy (EBUS-TBFB), large bore (19G) histology TBNA as well as endobronchial forceps biopsy~     will be performed in 90 consecutive patients with mediastinal lymph node enlargement and~     clinical and radiological features of sarcoidosis.~      Diagnostic accuracy of each sampling technique will be calculated and compared to other~     techniques. Diagnostic yield of different technique combinations will also be calculated and~     the most efficient diagnostic approach will be defined.~   "
132211|NCT01836809|"~     The prevalence of renal dysfunction after implantation of the artificial heart is high. The~     infusion of exogenous B-type natriuretic peptide (BNP) after implantation of the total~     artificial heart (TAH) improves renal function in a sustained manner. The renal protective~     and hormone-modulating effects of nesiritide may be enhanced with ventriculectomy compared to~     heart failure surgery that leaves the native myocardium intact. The goal of this project is~     to determine the renal protective effects of nesiritide after implantation of a mechanical~     device.~   "
132212|NCT01836796|"~     Recent data suggest that the trillions of bacteria in gastrointestinal tracts (gut~     microbiota) can function as an environmental factor that modulates the amount of body fat.~     Obese individuals have an altered gut microbiota and germ-free mice are resistant to~     developing diet-induced obesity and have lower fasting insulin and glucose concentrations and~     shows an improved glucose tolerance. Administration of the probiotic bacterium Lactobacillus~     Gasseri SBT2055 in fermented milk for 12 weeks reduced adiposity and body weight in obese~     adults possibly by reducing lipid absorption and inflammatory status. However, there are no~     controlled studies to the investigators knowledge that address whether probiotic~     supplementation affects glucose metabolism. The investigators hypothesis is that~     supplementation of Lactobacillus reuteri DSM 17938 may improve metabolic control in type 2~     diabetes patients. In addition, the investigators will explore possible mechanisms behind the~     antihyperglycemic action of Lactobacillus Reuteri.~   "
132213|NCT01836783|"~     The study will compare the density and strength of regenerated bone in extraction sockets~     after being grafted with two different materials: Bone Allograft and Bone Allograft with~     Amnion.~      The investigators hypothesize that sockets grafted with the Amnion graft will exhibit~     enhanced healing patterns and will accelerate the formation of regenerated bone in the~     grafted areas.~   "
132214|NCT01836770|"~     The purpose of this study is to describe the contrast flow patterns in the epidural space~     using the inferior-anterior approach with continuous fluoroscopic guidance, and determine how~     well this approach correlates with appropriate contrast flow patterns and with analgesia at~     follow up. This knowledge may prove useful in guiding physician practice patterns in the~     non-surgical management of low back pain.~      Hypothesis: The investigators hypothesize that there will be suitable (ventral/anterior)~     epidural contrast spread based on inferior-anterior needle-tip position, particularly with~     appropriate needle tip position.~   "
132215|NCT01836757|"~     To delineate the effect of MSM on osteoarthritis~   "
133034|NCT01825967|"~     The management of acute diverticulitis maybe better if we have prognostic markers of~     evolution.~      Hypothesis: C-reactive protein maybe a good prognostic marker of evolution of acute~     diverticulitis.~      The investigators need to know the values of C-reactive protein to predict evolution of acute~     diverticulitis.~   "
132217|NCT01836731|"~     Community Health Clubs to improve local sanitation, hygiene and health conditions have been~     implemented in several countries in Africa and Asia with some success. The Ministry of Health~     in Rwanda has committed to rolling out a program designed along similar lines, the Community~     Based Environmental Health Promotion Program (CBEHPP), in all 15000 villages across Rwanda.~     The main objective of the program is to achieve 'zero open defecation' in all villages of~     Rwanda, at least 80% hygienic latrine coverage and improvements in a range of health~     behaviors such as the use of mosquito nets, hand-washing with soap and the use of household~     water treatment.~      To evaluate the impact of the program on health, other socio-economic outcomes and community~     functioning, a single district has been chosen where 150 communities will be randomized to~     receive the intervention immediately or 18 months later. The evaluation is led by US based~     Innovation for Poverty Action (IPA) through researchers based at the National University of~     Rwanda, Georgetown University, London School of Hygiene and Tropical Medicine and New York~     University. The research team will work in close collaboration with the implementing team,~     which consists of the Ministry of Health, Rwanda and Africa AHEAD.~      The study will span three years, beginning in May 2013, and ending in late 2015.~   "
132218|NCT01836718|"~     The purpose of this study is to measure intrahepatic HCV RNA levels at the time of liver~     transplantation in patients receiving antiviral therapy while on the liver transplant waiting~     list. This will eventually be correlated with the degree of hepatic fibrosis present within~     different geographic sites in the cirrhotic liver. Tissue samples will be obtained from the~     patient's liver explant as well as hilar lymph nodes. Upon the removal of the cirrhotic liver~     at the time of transplantation, the explant will be biopsied multiple times in different~     segments of the liver and preserved for viral detection studies as well as analysis of the~     degree of fibrosis. Peripheral blood mononuclear cells (PBMCs) will be obtained for viral~     detection at the time of transplantation. Serum HCV RNA levels will also be obtained at 1~     month, 3 months and 6 months post liver transplantation.~      Study Hypotheses:~        -  Virological relapse or non-response is higher is patients with cirrhosis due to failure~          of antiviral medication to concentrate adequately in a fibrotic liver having an altered~          sinusoidal micro-architecture~        -  HCV may persist in different geographic regions of the fibrotic liver in part predicated~          on blood supply to that area and this may have an effect on overall virological~          response. These differences in viral persistence and detection may exist in different~          lobes of the liver or even within a few centimeters within the same portion of the liver~          parenchyma.~        -  PBMC and hilar lymph nodes may be extrahepatic reservoirs of HCV viral persistence in~          patients receiving antiviral therapy and may account for virological relapse~          post-therapy~        -  There may be varying degrees of fibrosis within the same cirrhotic liver which may~          impact on hepatic synthetic function and antiviral response to treatment.~   "
132219|NCT01836705|"~     Primary Objective:~      - To assess the effect of SAR302503 (500 mg) administered as 14-day repeated doses on the~     QTcF interval compared to 1-day placebo in patients with advanced solid tumors.~      Secondary Objectives:~        -  To assess the effect of SAR302503 administered as 14-day repeated doses on heart rate~          (HR), QT, QTcB, and QTcN, PR and QRS compared to placebo.~        -  To assess the clinical and laboratory safety of SAR302503~        -  To document the plasma concentrations of SAR302503 at the time of ECG investigation.~        -  To explore the Pharmacokinetic/Pharmacodynamic relationship between SAR302503~          concentration and QTcF~        -  To explore antitumor activity~   "
132220|NCT01836692|"~     This study is for patients having a course of chest radiotherapy treatment after receiving~     chemotherapy for the treatment of non-small cell lung cancer. Patients with non-small cell~     lung cancer have a risk of the tumour in the lung recurring or progressing after treatment.~      In this study, we will investigate:~        -  whether giving a more targeted and individualised type of chest irradiation or~          radiotherapy to the lung tumour (known as Isotoxic IMRT), is practical and whether it~          causes side effects which can be tolerated~        -  whether this new method of delivering the radiotherapy can reduce the risk of the tumour~          in the lung recurring or progressing~        -  whether survival can be improved by using this new radiotherapy method~      The dose of chest irradiation will be calculated specifically to suit patient's body shape,~     the position of the lung cancer, and how close healthy tissues are to the tumour.~     Radiotherapy will be delivered twice a day over a maximum period of 4.5 weeks. The duration~     of treatment will vary individually according to the delivered dose to the tumour area.~   "
132221|NCT01836679|"~     The purpose of this study is to evaluate the efficacy and safety of Chidamide combined with~     paclitaxel and carboplatin in patients with advanced non-small-cell lung cancer.~   "
132222|NCT01836666|"~     How are the health related quality of life among patients with chronic pain effected by~     interventional pain managment?~      Hypothesis:~      Health related quality of life can be improved by interventional pain management both among~     patients with localizable pain focuses and among patients among whom no pain focuses can be~     found.~      Method:~      Health related quality of life using EQ-5D and EQ-VAS is registered at first visit, at the~     time of treatment for pain focuses an during the following 12 months.~   "
132223|NCT01836653|"~     The purpose of this study is to evaluate efficacy and safety of mFOLFOX6+bevacizumab and~     mFOLFOX6+cetuximab for liver only metastasis from KRAS Exon 2 wild type (under protocol~     1.0-1.2 edition) and RAS wild type (under protocol 2.0 edition) colorectal cancer.~   "
132224|NCT01836640|"~     There are three major subtypes of breast cancer:~        1. Hormone receptor positive (contain cells that express the estrogen receptor or~          progesterone receptor).~        2. Tumors that express the epidermal growth factor receptor gene ( HER-2)~        3. Triple negative (cancer cells that lack the hormone receptors and the epidermal growth~          factor receptor gene HER-2.~      While effective therapies exist for most cases of breast cancer at first occurrence, many~     patients eventually exhibit disease that does not respond to all standard breast therapies,~     particularly in the metastatic setting.~      There are therapies that are used to treat other types of cancers with genetic mutations that~     are in the process of being evaluated for use in breast cancer. The current techniques used~     for detecting mutations in the genes of breast cancer patients, which can be treated with~     drugs specific for the genetic mutations, are invasive and identifying effective diagnostic~     non-invasive procedures are the next challenge for physicians. This study will compare the~     ability to detect genetic mutations samples from non-invasive procedures such as a blood~     draw, to more invasive procedures such as tissue taken from a biopsy sample.~      There is also a concern with current techniques used to detect genetic mutations that cells~     from a single tissue sample may not be representative of the types of cells present in all~     the tumors in the body and therapies selected using a single tissue sample may not be~     effective for all of the cancer in the body. This study will use blood drawn from~     participants prior to any drug therapy and compare the genes from this blood to tissue~     samples from multiple sites of disease.~      The study will also compare the genetic profile of the metastatic tumors to the genetic~     profile of the original breast cancer to determine if there are any changes in the genetics~     of the tumor cells.~      The participants that have newly diagnosed metastatic disease will provide tissue from their~     primary site of disease via an image guided biopsy. These participants will also provide~     tissue from at least 2 other distant metastatic sites (lung, pleural/peritoneal, liver,~     brain, or skin). Each biopsy procedure will attempt to obtain 2-3 samples for research~     purposes.~      Participants that have locally recurrent disease in the breast will have the tissue from the~     site of re-occurrence biopsied as well as two distant metastatic sites (lung,~     pleural/peritoneal, liver, brain, or skin). Participants that have either multi-centric~     disease or bilateral disease will have all tumors sampled with the intention of providing 2-3~     samples/tumor for research purposes. Participants with multi-centric and bilateral disease~     will also have 2 distant sites of distant disease sampled (lung, pleural/peritoneal, liver,~     brain, or skin).~      Prior to any scheduled biopsy procedures all participants will have a blood draw used to~     examine the genetics of the tumor cells in the blood. The participants will have 8 tubes of~     blood drawn for the test and then they will proceed onto the tissue sampling portion of the~     study.~   "
132459|NCT01833533|"~     The purpose of this study is to evaluate the safety and antiviral activity of~     ABT-450/ritonavir/ABT- 267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267~     also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin~     (RBV) in patients with chronic hepatitis C virus genotype 1a (HCV GT1a) infection without~     cirrhosis.~   "
132225|NCT01836627|"~     This research study includes children ages 5 to 20 years old with Collagen Type 6 Congenital~     Muscular Dystrophy or Laminin α2-related muscular dystrophy (LAMA2-MD). The goal of this~     study is to measure the effect of breathing exercise to stretch the chest in slowing the loss~     of breathing function. The breathing stretches are done with a machine called Cough Assist®.~      The study is being done at Cincinnati Children's Hospital Medical Center and Children's~     Hospital of Philadelphia. The study involves traveling to one of these 2 centers for 4 visits~     over 13 months. The study also includes 3 sets of phone visits called Daily Phone Diaries.~      Participants will be randomized into one of 2 study groups in a 1:1 ratio. The treatment~     group will use the Cough Assist® machine twice a day for 15 minutes. The control group will~     continue with their current daily care. The Cough Assist® is a machine that blows air into~     the lungs (insufflation) and helps pull air out of the lungs. The investigators will be~     blowing enough air into the lungs to cause a stretch to the chest. This is called~     hyperinsufflation.~      Study visits will last about 5 to 6 hours and will include medical and quality of life~     questionnaires and pulmonary function tests to determine lung function and the individualized~     settings to be prescribed for the Cough Assist®.~   "
132226|NCT01836614|"~     The purpose of this study is to determine if an intravenous lidocaine infusion (compared to~     placebo) intraoperatively will decrease time to return of bowel function postoperatively,~     decrease postoperative pain, diminish postoperative opioid requirement, minimize inflammatory~     markers and shorten time to discharge after colorectal surgery.~   "
132227|NCT01836601|"~     This study seeks to determine whether a family-centered nighttime communication intervention~     improves: 1) shared understanding by parents, residents, and nurses of hospitalized pediatric~     patient's medical plans, 2) parent-reported errors, 3) parent and provider experience of~     nighttime medical care.~   "
132228|NCT01836588|"~     It is to investigate to what extent a gentle tissue extraction of CIN lesions of the cervix~     will bring the same conclusion than the conventional cervix biopsy, but with less pain and~     morbidity, after patients were undergoing a conisation in order to treat CIN.~   "
132229|NCT01836575|"~     Optimal management of patients with advanced NSCLC and with PS 2 remains controversial and~     underrepresented in clinical trials, typically accounting for 5 to 10% of enrolled patients.~     Patient PS 2 proportion in population-based studies is considerably higher than that included~     in clinical trials. Management of patients with PS of 2 in clinical practice is empirical and~     inconsistent. Patients have median overall survival of 3 to 5 months in randomized trials,~     and treatment options include best supportive care, single-agent and combination~     chemotherapy. Retrospective studies have suggested that patients PS 2 may benefit from~     first-line chemotherapy in terms of symptom improvement and overall survival. In many of~     these studies, single-agent chemotherapy was compared with best supportive care alone. Data~     on the role of cisplatin-based combinations for patients with PS 2 is more scant, with one~     study questioning its benefit, and another interrupting accrual because of undue toxicity.~     With regards to carboplatin, the Cancer and Leukemia Group B (CALGB) study 9730 compared~     paclitaxel plus carboplatin versus paclitaxel alone in a subgroup of 107 patients with PS 2;~     the median overall survival was significantly longer in group treated with combination~     chemotherapy (4.7 versus 2.4 months). Combination chemotherapy with carboplatin and~     paclitaxel also produced a statistically significantly higher incidence of severe~     hematological and non-hematological toxicities. On the basis of aforementioned results, a~     recent European panel stated that carboplatin-based or low-dose cisplatin-based doublets~     might represent alternative options to single-agent chemoterapy in patients PS 2. Outside~     clinical trials, single-agent chemotherapy with a 3rd generation agent remains valid option~     for patients PS2. Results demonstrate that pemetrexed is an agent with established~     single-agent activity in NSCLC, and suggest it is a potential candidate for combinations with~     platinum and other agents currently utilized for patients with advanced NSCLC. Favorable~     toxicity profile of pemetrexed suggests that this agent is an ideal candidate for single~     agent testing and in combination among patients with PS 2. Substantial doubt remains in the~     comparative benefit from monotherapy versus combination. Starting dose and schedule of~     pemetrexed were set for this study based on its current labeling in the 2nd line treatment of~     metastatic NSCLC and 1st line treatment of malignant pleural mesothelioma.~   "
132230|NCT01836562|"~     This clinical trial is a single Arm, single centre to check the safety and efficacy of bone~     marrow derived autologous mono nuclear cells (MNC) (100 million per dose). Trial to be~     conducted for 36 months.~   "
132231|NCT01836549|"~     This molecular biology and phase II trial studies how well imetelstat sodium works in~     treating younger patients with recurrent or refractory brain tumors. Imetelstat sodium may~     stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.~   "
132232|NCT01836536|"~     Bevacizumab, a monoclonal antibody against vascular endothelial growth factor (VEGF), is an~     antiangiogenic treatment currently proposed to recurrent high grade glioma patients.~     Unfortunately some patients fail to respond to this treatment and finding biological factors~     allowing the discrimination between potential responders and non responders would be very~     helpful. As the immune system plays a key role in angiogenesis induction and maintenance in~     cancer, it could serve as a surrogate marker of angiogenesis in cancer patients.~      The purpose of this study is to determine the influence of bevacizumab treatment on~     circulating immune cells in high grade glioma patients and to search for a link between the~     variation of these cells and the response to treatment.~   "
132233|NCT01836523|"~     This trial is conducted globally. The aim of the trial is to confirm the efficacy and safety~     of liraglutide as adjunct therapy to insulin in the treatment of type 1 diabetes. The total~     trial duration per subject is approximately 58 weeks.~   "
132234|NCT01836510|"~     Multicentre study with the objective to correlate heart failure hospitalizations and deaths~     with Home Monitoring data in ICD/CRT-D recipients, in order to identify the combination of~     Home Monitoring data with the greatest sensitivity and specificity in predicting Heart~     Failure events.~      All data are prospectively collected.~   "
132235|NCT01836497|"~     The study is designed to confirm safety and efficacy of the SD01 ICD (implantable~     cardioverter-defibrillator) lead.~   "
132236|NCT01836484|"~     This is a prospective diagnostic performance study which compares three new imaging methods~     with the current standard imaging method for the diagnosis of metastatic lymph nodes.~   "
132237|NCT01836471|"~     The purpose of the study was to assess the clinical effect of QAW039 in non-atopic asthmatics~     taking low dose Inhaled Corticosteroid (ICS) as background therapy.~   "
132238|NCT01836458|"~     This study aims to determine the Minimum Inhibitory Concentration of KAE609 in adult male~     patients with acute, uncomplicated malaria due to P.falciparum monoinfection after single~     dosing with KAE609~   "
132460|NCT01833520|"~     The goal of this clinical research study is to find the highest tolerable dose of radium-223~     dichloride that can be given to patients with osteosarcoma.~      Radium-223 chloride is designed to work like radiation therapy in cells that are actively~     making bone. It is designed to target new bone growth in and around bone cancer and may kill~     cancer cells.~   "
135492|NCT01793792|"~     The purpose of this study is to evaluate the safety and efficacy of the Low Profile~     Visualized Intraluminal Support(LVIS™ and LVIS™ Jr.)devices from MicroVention, Inc. when used~     to facilitate endovascular coiling of wide-necked intracranial aneurysms with coils.~   "
132239|NCT01836445|"~     Young men who have sex with men (YMSM) account for almost 70% of HIV diagnoses among all~     young people in the U.S. and are alone in facing an increasing rate of infections. Because~     YMSM are less likely to receive relevant sexual health education in traditional settings~     (e.g. schools, community), the Internet is a unique route of reaching and helping YMSM.~      The purpose of this study is to compare two different versions of an online HIV prevention~     program for YMSM. The study is being conducted by researchers at Northwestern University in~     Chicago, Hunter College in New York City, and Emory University in Atlanta. A total of 900~     YMSM will be enrolled into this study from the clinics of community partners in Chicago, New~     York, and Atlanta.~      Participants will be randomly assigned to one of two versions of the program. Some topics in~     the program include HIV facts and myths, sexually transmitted infections (STIs), and condom~     use. All participants, regardless of the program version they receive, will also take at-home~     urine and rectal tests for the STIs chlamydia and gonorrhea. After completing the program,~     participants will be contacted three more times over the course of a year for follow-up~     sessions and surveys.~      The research team hypothesizes that the YMSM-specific prevention program will lead to a~     significant reduction in the frequency of unprotected anal sex acts and new STI infections~     compared to the HIV knowledge program that is for a general audience. The YMSM-specific~     program will also lead to improvements in secondary knowledge, motivation, and skills~     outcomes.~      In order for the research team to measure the effectiveness of the YMSM-specific prevention~     program and determine if the study hypothesis is correct, participants will be asked~     questions about themselves, including questions about their sexual orientation, sexual~     experiences, health practices, including drug use, health knowledge, and questions about~     their feelings and emotions. Based on this information, the research team hopes to later~     change, improve, or expand the program to better address the needs of YMSM.~   "
132240|NCT01836432|"~     Unfortunately, despite the best clinical efforts and breakthroughs in biotechnology, most~     patients diagnosed with pancreatic cancer continue to die from the rapid progression of their~     disease. One primary reason for this is that the disease is typically without symptoms until~     significant local and/or distant spread has occurred and is often beyond the chance for cure~     at the time of the diagnosis. The lack of any treatment to substantially increase long term~     survival rates is reflected by the poor outcomes associated with this disease, specifically~     time to disease progression and overall survival.~      However, another important part of the body is now being looked at as a target for therapy~     against this disease - the immune system. Scientists have clearly shown that pancreatic tumor~     cells produce a number of defective proteins, or express normal proteins in highly~     uncharacteristic ways, as part of this cancer. In some cancers, these abnormalities can cause~     an immune response to the cancer cells much in the way one responds to infected tissue. In~     progressive cancers however, the immune system fails to effectively identify or respond to~     these abnormalities and the cancer cells are not attacked or destroyed for reasons not yet~     fully understood. This clinical trial proposes a new way to stimulate the immune system to~     recognize pancreatic cancer cells and to stimulate an immune response that destroys or blocks~     the growth of the cancer.~      This new method of treatment helps the immune system of pancreatic cancer patients to~     identify the cancerous tissue so that it can be eliminated from the body. As an example,~     most people are aware that patients with certain diseases may require an organ transplant to~     replace a damaged kidney or heart. After receiving their transplant, these patients receive~     special drugs because they are at great danger of having an immune response that destroys or~     rejects the transplanted organ. This rejection occurs when their immune system responds~     to differences between the cells of the transplanted organ and their own immune system by~     attacking the foreign tissue in the same way as it would attack infected tissue. When the~     differences between foreign tissues and the patient's body are even larger, as with the~     differences between organs from different species, the rejection is very rapid, highly~     destructive, and the immunity it generates is longlasting. This is called hyperacute~     rejection and the medicine used to immunize patients in this protocol tries to harness this~     response to teach a patient's immune system to fight their pancreatic cancer just as the body~     would learn to reject a transplanted organ from an animal.~      To do this, Algenpantucel-L immunotherapy contains human pancreatic cancer cells that contain~     a mouse gene that marks the cancer cells as foreign to patient's immune systems. The immune~     system therefore attacks these cancer cells just as they would attack any truly foreign~     tissue, destroying as much as it can. Additionally, the immune system is stimulated to~     identify differences (aside from the mouse gene) between these cancer cells and normal human~     tissue as foreign. This education of the immune system helps treat the patient because~     pancreatic cancer cells already present in a treated patient are believed to show some of the~     same differences from normal tissue as the modified pancreatic cancer cells in the product.~     Due to these similarities, the immune system, once educated by the Algenpantucel-L~     immunotherapy, identifies the patient's cancer as foreign and attacks.~      The chemotherapy combination to be used in this study has been shown to improve survival in~     advanced pancreatic cancer and is being combined with an experimental pancreatic cancer~     immunotherapy that stimulates the immune system to recognize and attack the cancer. One goal~     of this study is to determine whether chemotherapy and immunotherapies can work cooperatively~     to increase anti-tumor effects to levels beyond what would be seen with either treatment~     alone.~      In this experimental study, all patients are given a strong combination of anti-tumor~     chemotherapies while some patients are also given injections of an immunotherapy drug~     consisting of two types of pancreatic cancer cells that we have modified to make them more~     easily recognized and attacked by the immune system. We propose to test this new treatment~     protocol in patients with locally advanced pancreatic cancer to demonstrate that treatment~     with the immunotherapy increases the time until the tumor progresses or increases overall~     survival when given in combination with the current standard of care therapy for this~     disease.~   "
132241|NCT01836419|"~     There are some differences between elderly and young adult patients regarding the anatomy of~     upper airways. Elderly patients have larger upper airways than young adult patients at all~     pharyngeal levels as revealed by CT. Another study explained that there is a progressive~     descent of the larynx and epiglottis with aging, which lengthens the upper airway and~     possibly makes it more likely to collapse.~      The aim of this study is to compare the clinical efficacy of laryngeal mask airway (LMA) in~     elderly patients with young adults. In this study, the investigators will measure the ease of~     insertion, success rate of insertion, the time of insertion, oropharyngeal leak pressure,~     gastric leak pressure, fiberoptic position and intraoperative complications of the classic~     LMA.~   "
132242|NCT01836406|"~     Partial nephrectomy is a widely accepted alternative to radical nephrectomy in patients with~     clinically localized, unilateral renal cell carcinoma and a normal contralateral kidney.~     Interruption of renal blood flow via pedicle clamping is often necessary during partial~     nephrectomy, especially for complex tumors with deep parenchymal invasion.~     Ischemia-reperfusion injury is a complex process involving several mechanisms including renal~     vasoconstriction, extensive tubular damage and glomerular injury. The investigators will~     examine the postoperative renal function of patients who received intraoperative ketorolac~     and remote ischemic preconditioning during partial nephrectomy.~   "
132243|NCT01836393|"~     To determine whether plai cream is effective in treating mild to moderate degrees of~     osteoarthritis of the knee in the elderly patient compared with placebo cream.~   "
132244|NCT01836380|"~     Hypothesis #1: The investigators hypothesize that both swimming training and cycling training~     will demonstrate significant improvements in endothelium-mediated vasodilation and central~     artery compliance in this population and that there will be no difference in the magnitude of~     increases between the water-based and land-based exercise interventions.~      Hypothesis #2: The investigators hypothesize that the improvements in endothelium-dependent~     vasodilation and arterial compliance in response to exercise training interventions will be~     related to the corresponding reductions in inflammatory biomarkers.~      Hypothesis #3: The investigators hypothesize that both swimming exercise and cycling exercise~     will improve functional capacities and disease progression in middle-aged and older adults~     with osteoarthritis.~   "
132245|NCT01836367|"~     Actinic keratoses (AK) are common cutaneous lesions associate with chronic ultraviolet~     radiation exposure. While most authorities consider AK as a pre-malignant lesion, some~     consider it as an incipient squamous cell carcinoma (SCC). Among the current therapies for~     the treatment of AK are excisional surgery, cryosurgery, electrodesiccation and curettage,~     topical chemotherapy and light therapies. Cryosurgery is considered the gold standard for~     therapy, however as with other lesion-directed therapies, cryosurgery does not treat~     subclinical lesions in the surrounding skin. Ingenol mebutate is the active compound in the~     sap from Euphorbia peplus L. (E. peplus). Topical ingenol mebutate treatment has been~     approved for the treatment of AKs. The goal of AK therapy for all physicians is to provide an~     effective, tissue-sparing treatment with good cosmetic results. Ingenol mebutate gel 0.015%~     has shown to not only have a high clearance rate but also a transient localized inflammatory~     skin response that resolves quickly without sequelae. However, one common fear about ingenol~     mebutate is that it's mechanism of action is purely destructive to both AKs and healthy skin,~     and that retreatment would produce an equally, if not more, caustic result on the skin such~     as severe erosion, scaling, and erythema. It is our hope to debunk this misconception and~     demonstrate that reapplication of a second cycle of ingenol mebutate would result in lower~     LSR scores compared to the LSR in the first cycle of application. We plan to treat 20~     subjects. Each qualifying subject will have at least 4-8 non-hypertrophic AKs in a 25 cm2~     treatment area on the face or scalp. All subjects will be treated with two cycles of ingenol~     mebutate 0.015%. The first cycle will be started on Day 1, and the second cycle will be~     started on Day 29 (four weeks apart). Subjects will utilize the once daily for three days~     regimen for both cycles.~   "
132246|NCT01836354|"~     DESERVE is a discharge education study using health workers to enroll and randomly assign 800~     subjects diagnosed with TIA, or mild stroke to either risk factor education or usual care.~     Those patients assigned to education will receive stroke preparedness education plus risk~     factor reduction education, and help accessing follow up care with health workers. Those~     patients assigned to usual care will receive written stroke preparedness education. This~     protocol will evaluate the effectiveness of this intervention to reduce blood pressure, and~     individual stroke risk factors and future stroke risk.~   "
132247|NCT01836341|"~     The purpose of this Phase I study is to test the safety of combining afatinib with standard~     chemotherapy and radiation. The drug afatinib will be given before the chemotherapy and~     radiation therapy to shrink the tumor and evaluate how afatinib affects the patient. This~     study will then test the safety of afatinib at different dose levels when combined with the~     chemotherapy drugs cisplatin or carboplatin, and pemetrexed. These treatments will be given~     during radiation treatment and the drug afatinib will be continued after chemotherapy and~     radiation.~   "
132248|NCT01836328|"~     The majority of current studies regarding the use of methadone (MTD) in the treatment of~     cancer pain are focused in its administration via the oral route (PO). The ratio considered~     from VO to parenteral route (BP) is 2:1. Academic literature assumes the ratio from BP to VO~     to be 1:2. In our unit, we use MTD in the context of ROP and not as the last opioid. If face~     with a situation where there is a good control of pain with MTD BP, usually we move to VO. We~     have observed that the traditional ratio tend to produce certain toxicity problems. Because~     of this, we have proposed a new ratio of conversion from PAR MTD to oral MTD, i.e. 1:1.2~   "
132249|NCT01836315|"~     Hypothesis: The investigators propose that obese parturients will have an increased~     inflammatory response and a decreased anti-inflammatory response to the surgical and~     anesthetic insult of caesarean section and that this will be associated with a higher rate of~     perioperative complications, as compared to non-obese parturients.2 Background: Obese~     patients exhibit higher levels of inflammatory markers than non-obese patients. Furthermore,~     obese patients have a higher incidence of perioperative complications, especially wound~     infections, and this is well documented in the caesarean section population. The pregnant~     population is unique as a result of the immunologic changes that occur at baseline, and an~     increase in pro-inflammatory markers is seen in serum and in placental tissue of obese~     subjects, and has been demonstrated to correlate with adverse fetal outcomes.~      Specific Objectives: To determine the baseline levels of three established markers of~     inflammation in term pregnant obese and non-obese patients (defined by a BMI > and < 35 kg/M2~     respectively), and examine how they change in response to the stress of surgery/anesthesia.~     The investigators will correlate the inflammatory response with the incidence of~     postoperative wound infections.~      Methods: Patients will be recruited to the study prior to the planned caesarean section.~     Blood samples for inflammatory marker levels will be performed preoperatively, immediately~     postoperatively, and at 24 hours postoperatively. Samples will be analyzed for pentraxin-3 (a~     relatively novel inflammatory marker), C reactive protein (CRP) (a well-known and clinically~     relevant inflammatory marker), and interleukin-10 (IL-10) (an established anti-inflammatory~     marker). Plasma will be analyzed by ELISA to determine levels of each biomarker. Patient~     charts will be reviewed to determine which patients have experienced surgical complications~     in the 30 days postoperatively. Surgical complications will then be correlated with the~     measured levels of inflammatory markers.~      Assuming that the levels of inflammatory cytokines in obese patients will be 15% higher in~     obese parturients and assuming an alpha error level of 5% and a beta error level of 20%, the~     investigators would need to study 18 patients per group to prove our hypothesis that~     inflammatory cytokine levels are correlated with postoperative infections. The investigators~     plan to study 20 patients per group to account for a potential patient attrition rate of 10%~     during the study.~      Significance/Importance: The connection between obesity and dysregulation of the~     perioperative inflammatory response has not been well established nor has perioperative~     inflammation in the obese population been linked to the observed increased in perioperative~     morbidity. The investigators hope to demonstrate these connections and hopefully will be able~     to identify at risk patients earlier, and in a subsequent study intervene to reduce the risk~     of postoperative wound infections with pharmacokinetically targeted antimicrobial~     prophylaxis.~   "
132250|NCT01836302|"~     Delirium in the ICU is a prevalent problem occurring in up to 80% of ICU patients. A~     potential cause of delirium in ICU patients could be cerebral hypoxia. Septic shock is~     associated with high rates of delirium.~      The aim of this pilot study is two fold. First, to determine the feasibility and potential~     challenges of measuring cerebral oxygenation in ICU patients with severe sepsis and septic~     shock. And second, to see if the incidence and magnitude of cerebral desaturations correlated~     with ICU acquired delirium as measured by the Confusion Assessment Method (CAM) scores.~   "
132251|NCT01836289|"~     This research is being done to see if people with Crohn's disease who receive high-dose~     cyclophosphamide have an improvement of their disease, how long the benefit may last, and how~     safe cyclophosphamide is. This study is for patient with medically refractory disease that is~     not easily amenable to surgery.~      Cyclophosphamide is an FDA-approved chemotherapy medication that is also frequently used to~     treat autoimmune illness; use of cyclophosphamide for autoimmune disease is not approved by~     the FDA. An autoimmune illness is when the immune system mistakenly attacks self, targeting~     the cells, tissues, and organs of a person's own body. There are many different autoimmune~     diseases and they can each affect the body is different ways. Crohn's disease is an~     autoimmune disease that primarily affects the small and large intestines. High~     dose-cyclophosphamide has been successfully used to treat Crohn's, primarily as part of a~     conditioning regimen for autologous stem cell transplantation. However, this therapy is~     limited in Crohn's because of it's serious infectious risks. This current study involves~     using high-dose cyclophosphamide without need for stem cell transplantation. This appears to~     be a safer approach in other autoimmune illnesses that have been studied.~   "
132252|NCT01836276|"~     The purpose of this study is to describe the differences in quitting smoking between African~     Americans (AA) and White smokers treated with varenicline.~   "
132253|NCT01836263|"~     Systemic sclerosis is an orphan, multiorgan disease affecting the connective tissue of the~     skin and several internal organs.~      Digital ulcers are frequent and have a major impact on the quality of life in patients with~     systemic sclerosis. The etiology of digital ulcers is complex and multifactorial and the~     principal mechanisms underlying the digital ulcers formation are ischemic, mechanic and~     inflammatory, alone or in combination, on the basis of the systemic sclerosis vasculopathy.~     Consequently, there are at least three types of DU: (i) those localized at the tips of the~     fingers and toes, mainly resulting from an ischemic process, (ii) those localized on the~     dorsal aspect of the fingers where the skin retraction due to fibrosis over bony prominences~     seems to be the main cause, and (iii) those evolving on a pitting scar or subcutaneous~     calcinosis due to a combined irritative-inflammatory mechanism. An early therapy to prevent~     or rapidly heal digital ulcers is today considered a mandatory approach to maintain quality~     of life and spare the enormous costs due to conventional digital ulcer management.~      This observational trial is part of the collaborative project DeSScipher, one out of five~     observational trials to decipher the optimal management of systemic sclerosis.~      Aim of this observational trial is:~        1. To identify the best treatment combination for prevention of digital ulcers in patients~          with fulfilment of the new ACR/EULAR SSc criteria or the preliminary VEDOSS criteria for~          very early diagnosis of systemic sclerosis~        2. To identify the best treatment associated with improved healing of digital ulcers in~          patients with fulfilment of the new ACR/EULAR SSc criteria~      Thus, the observational trial consist of a prevention arm and a healing arm.~   "
132254|NCT01836237|"~     Background: There are no published studies regarding the use of wound protectors in the~     context of surgical site infection (SSI) rates among patients receiving a~     pancreatoduodenectomy (Whipple) with preoperatively placed intrabiliary stents. In high~     volume experiences, the SSI rate is 40-50% within this cohort. In Calgary, preoperative~     biliary stent placement for bile duct decompression represents the norm given typical~     surgical wait times. In addition to having higher associated lengths of hospital stay, ICU~     admissions, hospital re-admissions, and overall mortality, patients with SSI are also~     delayed, and often omitted, in their progression to critical oncologic adjuvant chemotherapy.~     As a result, SSI remain crucial and devastating complications for pancreas surgeons and their~     patients alike.~      Methods: The investigators will complete a randomized controlled trial evaluating the rate of~     SSI in adult patients who undergo a pancreatoduodenectomy following biliary stent placement~     when wound protectors are employed versus no wound protector use. This trial will employ~     block randomization. All four University of Calgary Heapato-Pancreatico-Biliary (HPB)~     surgeons will participate with a planned inclusion of all patients scheduled to undergo a~     pancreatoduodenectomy.~      Analysis: The investigators will use an intention to treat approach to the analysis.~     Categorical baseline data will be analyzed using the Fisher exact probability test.~     Non-categorical baseline data will be analyzed using the Student t test. SSI rates will be~     determined using the Fisher exact probability test.~      Hypothesis: Wound protectors will reduce the SSI rate in patients undergoing a~     pancreatoduodenectomy with preoperatively placed intrabiliary stents.~      Potential Impact: Given the tremendous oncologic, economic, and psychological impact of SSI~     following pancreatoduodenectomy, the epidemic incidence of this complication must be reduced.~     The additional crippling effect of refusing (Medicare) payment for any patient who receives a~     SSI in the United States has launched all techniques and analyses that can potentially reduce~     this complication into the National health care agenda. In Canada, health care utilization~     and economics are always a relevant and ever expanding area of importance. It is crucial that~     the investigators reduce complications such as SSI, regardless of individual payer sources.~   "
132489|NCT01833143|"~     The purpose of this study is to test the drug Bortezomib to see how well it works. The~     investigators want to find out what effects, good or bad, it has on patients with a limited~     smoking history or who have a specific mutation associated with their lung cancer.~   "
132255|NCT01836224|"~     The Patient evaluated in Emergency room since admission and detailed history and clinical~     examination done .The in hospital cases where sepsis is the culprit and shifted to Intensive~     Care Unit (ICU) in view of septic shock were included since onset of shock.~      Initial fluid resuscitation done and if the patient were no fluid responsive they were~     randomized into arms noradrenaline or terlipressin and the dose escalated to achieve the~     primary objectives. At the same time the strict vitals monitoring and standard medical~     therapy for sepsis including antibiotics and other supportive therapy continued. The patients~     were followed up till discharge, death or up to 28days after enrollment into the protocol~     (whichever the longest). The detail methodology has been explained in column 14 later.~   "
132256|NCT01836211|"~     -  The purpose of this study is to determine the efficacy and safety of an evaluation~          strategy based on utilization of high sensitivity cardiac troponin T (hscTnT), followed~          by coronary computed tomography angiography (CCTA) in patients with low-intermediate~          risk chest pain consistent with a possible acute coronary syndrome compared to a~          standard of care (SOC) strategy.~        -  Unicentric, randomized, controlled, open label clinical trial that will compare a fast~          strategy (hscTnT followed by CCTA) with a SOC strategy (serial ECG and cardiac~          biomarkers followed by stress/rest imaging study).~   "
132257|NCT01836198|"~     The purpose of this study is to examine the effect of gemfibrozil, ketoconazole, and~     clarithromycin on how much LY2409021 is found in the bloodstream and how long the body takes~     to get rid of it. The study is split into two parts, Part A and Part B. Participants in Part~     A are divided into two cohorts (groups). Each cohort will participate in two study periods.~     Period one involves a single dose of LY2409021. Period two involves either gemfibrozil or~     ketoconazole for 21 days with LY2409021 given once on Day 4. Part A will last for 51 days and~     will also involve screening within 27 days of the start of the study. Part B is only open to~     participants who successfully completed Part A of the study. Participants in Part B will~     receive one single dose of LY2409021 on Day 4 and clarithromycin for 21 days. Part B will~     last for 29 days and will also involve screening within 27 days of the start of the study.~   "
132258|NCT01836185|"~     The purpose of this study is to measure how much of the drug gets into the bloodstream and~     how long it takes the body to remove it when given to participants with hepatic (liver)~     impairment compared to participants with normal hepatic function. Information about any side~     effects that may occur will also be collected. This study will last approximately 28 days,~     not including screening.~   "
132259|NCT01836172|"~     The purpose of this study is to evaluate the safety and efficacy of YJP-14 capsules for the~     treatment of endothelial dysfunction in patients with diabetes mellitus.~   "
132260|NCT01836159|"~     A pilot randomized, two parallel group study comparing an iPad software game application~     versus standard care in post-stroke patients.~      Study hypothesis: Tablet PC technology using the iPad is a feasible and potentially~     efficacious tool which has the potential to promote fine motor recovery of the upper~     extremity after stroke.~   "
132261|NCT01836146|"~     The purpose of this First-in-Human Clinical investigation is to evaluate the safety and~     performance of the St. Jude Medical EnligHTN™ Generation 2 Renal Denervation System for the~     treatment of patients with drug-resistant uncontrolled hypertension.~   "
132262|NCT01836133|"~     This multicenter, observational study will evaluate the efficacy and safety of Tarceva~     (erlotinib) in participants with locally advanced or metastatic adenocarcinoma non-small cell~     lung cancer and an ECOG performance status of 0-1. Eligible participants receiving Tarceva~     according to the Summary of Product Characteristics and local label will be followed for the~     duration of their treatment.~   "
132263|NCT01836120|"~     A study of Raltitrexed plus Docetaxel versus Docetaxel as second-line chemotherapy in~     subjects with Gastric Cancer.The purpose of this study is to compare the activity of~     Raltitrexed plus Docetaxel versus Docetaxel as second-line chemotherapy in subjects with~     gastric carcinoma by estimating progression free survival (PFS) in each treatment arm.~   "
132264|NCT01836107|"~     The purpose of this study is to make a Spanish version of a score that evaluates the~     characteristics of a good quality clinical note for the purpose of physician communication.~     The score is an instrument, originally made in English. Due to the score will be used in a~     different country, language and culture of the original protocol, it is necessary apply a~     process of translation and adaptation to the context where the score is going to be applied.~      The process of validation implies to evaluate if the instrument produces the same results~     under similar conditions and if the instrument maintains the ability to measure the same~     features or characteristics according to the original design.~   "
132265|NCT01836094|"~     The purpose of the study is to evaluate whether low-dose USP methylene blue (MB) will: i)~     improve short-term memory retention in a delayed match-to-sample task, ii) reduce reaction~     time in a psychomotor vigilance test, and iii) enhance responses to a visual-motor task as~     measured by functional magnetic resonance imaging (fMRI).~      A single low-dose MB or placebo will be orally administered to self-declared healthy adults~     using double-blind study design. Non-invasive fMRI data will be acquired before and after MB~     administration in the same subjects. Each study will take 2-3 hours, inclusive of an hour~     break in between.~   "
132266|NCT01836081|"~     The aim of this study is to investigate usefulness of the respirophasic variation in carotid~     artery peak flow velocity measured by Doppler ultrasound, which is noninvasive and easily~     accessible, as a predictor of fluid responsiveness in patients with coronary artery disease.~   "
132267|NCT01836068|"~     To find out if it is possible for HIV-1 patients to maintain antiretroviral medications~     during allogeneic bone marrow transplant~   "
132303|NCT01835587|"~     The purpose of the study is to determine the maximal tolerated dose and schedule of CC-486~     (also known as oral Azacitidine) in patients with AML or MDS after allogeneic HSCT.~     Allogeneic hematopoietic stem cell transplantation (HSCT) is more frequently used in Acute~     Myloid leukemia (AML) or Myelodysplastic Syndromes (MDS) as a potential curative therapy.~     However, disease recurrence/relapse and graft-versus-host disease (GVHD) remain the principal~     causes of fatal complications after transplantation. Azacitidine has significant activity in~     MDS and AML. Azacitidine has also demonstrated immunomodulatory activity in AML patients~     after allogeneic HSCT. An oral formulation of Azacitidine provides a convenient route of~     administration and an opportunity to deliver the drug over a prolonged schedule.~   "
132268|NCT01836055|"~     -  The investigators are conducting a magnetic resonance imaging (MRI) study comparing two~          MRI contrast agents in people with clinically isolated syndrome and relapsing remitting~          multiple sclerosis (MS). MS is a disease that affects the white matter and gray matter~          in the brain. MRI is used as a gold standard to visualize the degenerative changes in~          the brain and spine. The neurologist will usually order an MRI to confirm the diagnosis~          of MS using conventional imaging methods. These images reveal two main pieces of~          information regarding (a) the location of the lesions and (b) the status of the lesions.~          While the location of the lesions directly correlates with the clinical symptoms, the~          information about the status of the lesions informs the neurologist whether the lesion~          is new (active) or old (chronic).~        -  This ability to differentiate new and old lesions requires the use of a contrast agent.~          Currently, used agents reveal some lesions but it is unclear if they reveal the full~          extent of the disease. In new lesions, there may be a leakiness in the blood vessels and~          if the contrast agent leaks out then the investigators can see this. In healthy~          controls, the blood brain barrier is usually intact and this leak does not happen. One~          open question is: can the extravasation of the contrast agent to the brain precede the~          major tissue damage that we see in the structural MRI?~        -  Recently, a new FDA approved contrast agent (Gadavist) has been released and has~          enhanced characteristics in terms of affecting the MR signal resulting in a better~          contrast in the image and therefore, better diagnosis of the status of the disease.~          Given its high relaxivity, a small amount of Gadavist may show a better signal~          enhancement affected tissue for multiple sclerosis patients. The investigators~          hypothesize that Gadavist will reveal more tissue damage (lesions) than Magnevist and,~          therefore, may present a better tool for early diagnosis of brain damage.~        -  The investigators' goal in this research project is to see if the newer contrast agent~          is able to detect changes and differentiate healthy from affected tissue in the white~          matter and gray matter earlier than current contrast agents so that detection can be~          possible before major damage occurs to the tissue. Each person will be scanned initially~          with one agent and then between 8 and 30 days later with the other agent. The MR data~          processing results will be compared to check the efficacy of each contrast agent.~   "
132269|NCT01836042|"~     The purpose of this study is to assess the long-term safety of the Glaukos® iStent®~     Trabecular Micro-Bypass Stent Model GTS100R/L in subjects previously enrolled in Glaukos~     Study GC-003.~   "
132270|NCT01836029|"~     The purpose of this study is to compare the progression-free survival of patients with~     recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) treated with~     VTX-2337 + cisplatin or carboplatin + 5-FU + cetuximab versus patients treated with cisplatin~     or carboplatin + 5-FU + cetuximab alone (standard-of-care; SOC). Safety and overall survival~     will also be evaluated.~   "
132271|NCT01836016|"~     The aim of this study is to compare the effectiveness and economic evaluation of three~     treatments for Chronic Obstructive Pulmonary Disease (COPD) patients: one, conventional~     medicine based on 2011 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and~     Chinese Treatment Guidelines; another, TCM treatments, which have been evaluated and have~     certain effect; and finally, combination of both conventional medicine and TCM treatment,~     then determine which treatment is the most suitable for COPD patients.~   "
132272|NCT01836003|"~     Access to highly active antiretroviral therapy can improve maternal health outcomes for the~     4000 HIV- infected women who give birth daily and nearly eliminate transmission of HIV to~     their infants. However, system inefficiencies, particularly CD4 testing to determine~     treatment eligibility, are barriers. The project aims to study the effectiveness of a~     programmatic intervention at improving antenatal access to treatment.~   "
132273|NCT01835990|"~     Trauma patients are at a high risk of developing blood clots in the legs (deep vein~     thrombosis - DVT), which can travel to the lungs and cause serious health consequences.~     Often, these patients cannot receive blood-thinning medication to prevent these blood clots~     because of the risk of bleeding; in this case, they are usually given intermittent pneumatic~     compression devices (IPCs) to prevent blood clots. IPCs are inflatable sleeves that fit over~     the legs and periodically inflate and deflate, helping to pump blood out of the legs and thus~     reduce the risk of blood clot formation. Several studies suggest that IPCs are working~     properly on the patient only 60-70% of the time. Some patients also find them uncomfortable.~     A new device (geko) that works by stimulating the leg muscles and increasing blood flow in~     the legs has recently been developed. To compare the geko with IPCs, this study will randomly~     assign trauma patients who cannot receive blood thinners for blood clot prevention to either~     IPCs or geko. The main goal is to determine the feasibility of doing a larger study which~     would compare the efficacy of these devices in preventing blood clots. The amount of time the~     devices are properly used on the patients, comfort and tolerability, development of blood~     clots, and blood flow in the leg veins and arteries will also be measured and compared~     between the devices.~   "
132274|NCT01835977|"~     Multi-centre Randomized Clinical Trial: 200 patients with confirmed unilateral high-volume~     low risk (Gleason score 3 + 3) or intermediate risk prostate cancer (Gleason score 3 + 4)~     will undergo an IRE treatment. These patients will be randomized into one of the two groups~     of the study.~      Group 1: Focal ablation of the prostate at the side of the positive biopsies (focal-ablation)~     Group 2: Extended ablation of the prostate (extended ablation)~      Patients will have an ultrasound of the prostate and the imaging data will be entered into~     the Planning Software system of the IRE-device. The volume of the prostate is measured and a~     specified ablation zone will be determined. The patients will be admitted for overnight stay~     in the hospital on the morning of the scheduled IRE procedure. The IRE will be performed~     under general anaesthetic and the specified zone identified in the planning stage will be~     ablated. Two to four IRE electrode needles will be placed into the prostate under ultrasound~     image guidance with a perineal approach using a brachytherapy grid. When the needles are in~     place, electric pulses of one to two minutes duration are used to ablate the specified zone.~     The total procedure time will be approximately 1 hour.~      Safety data will be collected and patients will be followed up at 1 day post-operatively, 1~     month, 3 months, 6 months and 1, 2 and 3 year(s) post IRE.~   "
132275|NCT01835964|"~     The purpose of this study is to investigate how blood sugar changes in response to insulin~     and what the body does to counter-act low blood sugar in people with Type 1 Diabetes~     Mellitus. Insulin sensitivity is the term used to describe blood sugar changes within the~     body in response to insulin. Greater understanding of insulin sensitivity, particularly how~     the body responds to low blood sugar, will help us to better predict how blood sugar levels~     will change.~      All subjects will receive a liquid mixed-meal and will have their blood sugar response~     monitored in order to study insulin sensitivity. All subjects will receive additional insulin~     injections that are given to cause a low blood sugar in order to understand how the body~     responds to a low blood sugar. All subjects will be closely monitored during the time the~     insulin is given, by frequent checks of blood sugar and constant medical and nursing~     supervision. Details of the visits, tests and procedures are described below. During this~     study, the study team will ask that subjects to use their own insulin pump and own~     glucometer. Subjects will need to use the same glucometer for the entire study. Subjects will~     be provided 1 box of strips. Subjects will be required to use lispro (Humalog) insulin 2-3~     days before your inpatient admission which will be provided free of charge.~   "
132276|NCT01835951|"~     Simulation-based training is essential in learning or maintaining skills in high risk~     industry such as aviation and railway and in the medical field like anaesthesia. Debriefing~     following simulation is fundamental in order to reduce the emotional impact of the session~     and to asses the technical and non-technical skills (behavior). Even if the ideal debriefing~     method is still to be found, individual debriefing is considered as the gold standard but~     time consuming. The DEBRIEF-SIM study is a prospective, single blinded, multicentric and~     randomized study that will compare the individual (defined by learning couple resident and~     nurse) approach to a grouped (several couples) debriefing. The primary end point is to define~     the noninferiority of this approach compared to the individual one on the educational impact.~      The learners will be debriefed according to their randomization after the first session, but~     will all undergo individual debriefing following the second session.~   "
132277|NCT01835938|"~     Chronic Hepatitis C Virus (HCV) infection is a major cause of liver cirrhosis and~     hepatocellular carcinoma world-wide. Current combination therapy of pegylated~     interferon-alfa, ribavirin and protease inhibitors is limited by resistance and substantial~     side effects.~      The investigators identified epidermal growth factor receptor (EGFR) as host factor for HCV~     infection. Inhibition of kinase function of EGFR by approved inhibitor Erlotinib (TarcevaTM)~     broadly inhibits HCV infection of all major genotypes including viral escape variants~     resistant to host immune responses.~      Completed preclinical proof-of-concept studies in HCV cell culture and animal model systems~     demonstrate that inhibition of EGFR function by Erlotinib constitutes a novel antiviral~     approach for prevention and treatment of HCV infection (European patent application EP 08 305~     604.4, Filing date: September 26, 2008; Inserm, Paris, France and Lupberger et al. Nature~     Medicine 2011).~      Since Erlotinib (TarcevaTM) is an established approved drug for cancer treatment and has a~     well characterized safety profile in humans, the aim of the study is to investigate the~     safety, efficacy and pharmacokinetics of Erlotinib, a first-in-class entry inhibitor, for~     treatment of HCV infection in a randomized placebo-controlled double blind clinical trial in~     patients chronically infected with HCV. Following completion, this trial will set the stage~     for a further investigation of entry inhibitors as antivirals in combination with standard of~     care or direct antivirals such as HCV protease inhibitors. Thus, this randomized clinical~     trial will be an important step in the development of novel urgently needed antiviral~     therapies overcoming resistance.~   "
132278|NCT01835925|"~     The purpose of this study is to study which genes are abnormal in rectal cancer and see if~     this predicts how well chemotherapy and radiation will reduce the size of cancer and whether~     cancer recurs after surgery.~   "
132279|NCT01835912|"~     Ingestion of sodium citrate (Na-Cit), an alkalizing agent, increases extracellular pH via~     liver oxidation by decreasing [H+] and increasing bicarbonate concentration (HCO3-). Studies~     have confirmed that increasing extracellular pH promotes the efflux of La- and H+ from active~     muscles. This is due to an increase in activity of the pH sensitive monocarboxylate~     transporter as the gradient of intracellular versus extracellular H+ increases. Therefore,~     artificially inducing alkalosis prior to anaerobic exercise may reduce intracellular acidosis~     and increase the time to fatigue - defined as a decrease in force production with an~     increased perception of effort. The investigators will test the null hypothesis that sodium~     citrate ingestion (chronic and acute) will not have an effect on exercise performance~     compared to placebo.~   "
132280|NCT01835899|"~     To investigate safety, tolerability, and pharmacokinetics of multiple rising oral doses of BI~     1015550 in healthy male volunteers~   "
132281|NCT01835886|"~     To determine if stair climbing can be used as a measure of progress in persons with pulmonary~     disease.~   "
132282|NCT01835873|"~     Regional anesthesia (spinal, epidural) is considered the method of choice for anesthesia~     obstetric deliveries because of the ability to use fewer drugs, a more direct experience of~     childbirth and the capability to provide excellent postoperative analgesia. However, the~     incidence of hypotension after spinal anesthesia for cesarean delivery is high and can lead~     to maternal and fetal morbidities. Certain interventions may reduce the incidence and~     severity of spinal anesthesia induced hypotension, including the use of vasopressors and~     intravenous pre- or co-hydration using different types of volume expanders; crystalloid or~     colloid solutions. Such interventions aim to increase maternal cardiac output, which is the~     key in attenuating the hypotensive response to spinal anesthesia.~      The primary purpose of this study is to compare the efficacy of intravenous prehydration~     (preloading) of healthy parturients scheduled for caesarean section with either a crystalloid~     (Ringer's lactated) or colloid solution (HES 130/0.42) in the prevention of hypotension after~     spinal anesthesia.~      The FloTrac/VigileoTM device provides continuous monitoring of maternal cardiac output by~     employment of a minimally invasive technique based on arterial pulse contour analysis.~     Assessment of maternal hemodynamic status using the FloTrac/VigileoTM constitutes a secondary~     outcome. Other secondary outcomes are total amount of vasopressors used, neonatal outcome,~     intraoperative side effects and maternal satisfaction scores.~   "
132283|NCT01835860|"~     To evaluate whether Prostatic Artery Embolization (PAE) might be an effective alternative~     treatment option for benign prostatic hyperplasia (BPH), in comparison to current gold~     standard surgical treatment- Transurethral Resection of Prostate (TURP).~   "
132284|NCT01835847|"~     Accumulating evidence suggests a role of G protein-coupled inwardly-rectifying potassium~     (GIRK) channel in the pathology of excitement of nerve, and the medicine with the action~     (like the Tipepidine Hibenzate) is expected as a new curative medicine of adolescent~     depression.~      The purpose of this research is to confirm the effect by carrying out the additional dosage~     of the Tipepidine Hibenzate to the adolescent patients with depression.~      If suggestion is obtained by this research about the effect on adolescent patients with~     depression of Tipepidine Hibenzate, it can contribute to development of the medical treatment~     of adolescent patients with depression.~   "
132285|NCT01835834|"~     To evaluate the clinical performance and survival rate of NobelProceraTM Bridge Shaded~     Zirconia on natural teeth in the posterior region for a period of 5 years. The working~     hypothesis of this clinical study is that industrial centrally produced 3- or 4-unit bridges~     of shaded yttrium-oxide partially-stabilized (Y-TZP) zirconia (NobelProceraTM Shaded~     Zirconia) in combination with a veneering ceramic material will show sufficient CDA ratings~     (80% R+S) and a sufficient survival rate (93%) after 5 years in comparison with a reference~     level of 95%.~   "
132287|NCT01835808|"~     Functional evaluation of coronary lesions, through the evaluation of fractional flow reserve~     (FFR) with pressure-wire in patients with coronary artery disease (CAD) was evaluated in a~     randomised trial - the FAME trial - where it was showed to be superior to classic anatomical~     evaluation. Based on these results, current guidelines recommend the use of FFR (class I-A~     recommendation) when objective evidence of vessel-related ischemia is not available. Since~     the FAME trial was published, FFR use increased dramatically in most European countries,~     Portugal being no exception to this trend. FFR is currently being used in many interventional~     cardiology centres quite beyond the European Guidelines recommendation, since many physicians~     now trust more on the information they can collect with pressure-wire during the angiography,~     and less on non invasive imaging stress tests.~      Considering this widespread use of FFR in the evaluation of patients with CAD, there is a~     need to clarify the clinical results of this approach in a real patient setting. The~     Portuguese Study on The Evaluation of FFR Guided Treatment of Coronary Disease (POST-IT) was~     planned to evaluate if the use of FFR in the decision of coronary revascularization is~     feasible and allows optimized clinical results in real world non selected patients, as~     showed in clinical randomised trials.~   "
132288|NCT01835795|"~     The purpose of this study is to evaluate the efficacy of treatment of radial shockwave in~     myofascial pain syndrome in the lumbar region compared to placebo through questionnaires and~     imaging exams.~   "
132289|NCT01835782|"~     The purpose of this study is to determine the safety of L-Serine in subjects with Amyotrophic~     Lateral Sclerosis (ALS) at varied doses.~   "
132290|NCT01835756|"~     The purpose of this study is to determine whether the Erchonia® ML Scanner (MLS) is effective~     in the treatment of acute minor episodic chronic low back pain of musculoskeletal origin.~   "
132291|NCT01835743|"~     The purpose of this study is to determine whether the Erchonia HPS Laser is effective in the~     treatment of chronic heel pain arising from plantar fasciitis.~   "
132292|NCT01835730|"~     This study is a first-in-human randomized, double-blind (Investigator and subject), placebo~     controlled single ascending dose study that will enroll approximately 40 (6 active/2 placebo~     per dose group) adult male and female subjects with Type 2 Diabetes Mellitus (T2DM).~   "
132293|NCT01835717|"~     Before Alzheimer's disease (AD) clinical symptoms appear, there is a long period when changes~     in the brain occur. In this long asymptomatic period or preclinical phase, studies with~     populations at risk of developing AD have shown cognitive differences compared to control~     groups without such risk. There is a need for short, sensitive, easily administered,~     reproducible, non-expensive and independent of socio-demographic influences tests enabling~     the detection of pre-symptomatic variations in memory, when the memory decline is still~     within a normal range.~      Study main hypothesis: When evaluated with high-demanding tests of memory and executive~     function, the cognitive performance of cognitive healthy people aged between 45 and 65 and,~     extensively, to a group of up to 75 years, will vary significantly depending on clinical,~     socio-demographic and genetic features~   "
132294|NCT01835704|"~     To establish the cost per QALY (Quality Adjusted life Years) gained all patients that are~     referred to a specialized interventional pain clinic are assessed by Euroqol EQ-5D to measure~     the health-related quality of life at the first visit and then during the following year.~     Quality of life is calculated from EQ-5D by using hte TTO-validated UK-value set. With this~     and calculations of the cost we will be able to calculate the cost per QALY-gained which~     makes it possible to compare interventional pain managment to other treatments for pain~     patients.~   "
132295|NCT01835691|"~     This study is to research two questions. First, is vitamin D3 more effective than vitamin D2~     in raising 25-hydroxyvitamin D [25(OH)D] levels in chronic kidney disease (CKD) patients? And~     secondly, what are the differential effects of vitamin D2 and vitamin D3 on other mineral~     metabolism parameters?~   "
132296|NCT01835678|"~     Diabetes mellitus is a metabolic disease with a growing prevalence worldwide, affecting 171~     million people in 2000 and an expected 366 million people in 2030 (1) and therefore diabetic~     nephropathy is rapidly increasing in the Western hemisphere and represents in up to 50 % the~     cause of end stage renal disease. Hence, early intervention is desirable to prevent any~     damage to the kidneys. In the early stage of diabetic nephropathy, endothelium dysfunction is~     a key pathogenetic process as indicated by increased leakage of albumin through the~     glomerular barrier (2).~      Hence, improvement of endothelium function is an attractive therapeutic goal of antidiabetic~     medication. Endothelial dysfunction, in particular basal nitric oxide activity, has been also~     identified as pivotal determinant of glomerular filtration rate (3).~      A new and promising class of antidiabetic drugs are the gliptins. Gliptins act by inhibiting~     the enzyme dipeptidyl peptidase-4 (DPP-4), which is responsible for the rapid inactivation of~     glucagon-like peptide-1 (GLP-1) - an incretin hormone of the gut (6 - 8), thereby enhancing~     and prolonging the effects of GLP-1. GLP-1 - member of the incretin hormones - is released~     into the blood after meal ingestion and stimulates the insulin secretion in a glucose~     dependent manner. This accounts for the marked prandial insulin response, which prevents~     prandial hyperglycemia.~      Apart from surrogate parameters like reduction of fasting and postprandial blood glucose~     levels or improvement of HbA1c, the effect of gliptins on micro- and macrovascular function~     and cardiovascular outcome has not been the primary focus of current studies. However,~     infusion of GLP-1, the incretin hormone affected by gliptins has been reported to ameliorate~     endothelial dysfunction in patients suffering from coronary artery disease (9) and it was~     recently shown that infusion of GLP-1 into healthy human subjects increases both normal and~     ACh-induced vasodilatation (10). In studies on rats with diabetes, GLP-1 infusion nearly~     re-established their normal vascular tone (11) and there are further data from experimental~     animals that indicate a beneficial effect of GLP-1 on endothelial function (12).~      It is of major interest whether therapy with gliptins improves endothelial function of the~     micro- and macrovasculature. In face of the burden that diabetic nephropathy causes, the~     effect of linagliptin on the renal vasculature and endothelium integrity of the renal~     circulation (as measured by the availability of nitric oxide), is a key stone in order to~     claim that linagliptin is an effective antidiabetic agents. There is a need to demonstrate~     that linagliptin is effective beyond its blood glucose lowering actions and improves vascular~     endothelium function in the kidney.~   "
132297|NCT01835665|"~     The purpose of this study is to determine the maximum tolerated dose of nimodipine as well as~     the safety and tolerability of oral nimodipine in progranulin mutation carriers in~     preparation for longer term efficacy studies in patients with frontotemporal dementia due to~     progranulin gene mutations.~   "
132298|NCT01835652|"~     Parkinson's disease is caused by a reduction of dopamine causing motor deficits. The~     investigators are studying how exercise can help PD patients by increasing dopamine release~     in an area of the brain that coordinates movement, the striatum. The investigators will~     enroll PD patients into two groups; one group will complete a 12-week aerobic exercise~     program and the other will complete a 12-week control program including yoga and stretching~     only. The investigators will measure changes in dopamine release before and after either~     12-week intervention. Subjects will complete motor and cognitive questionnaires in addition~     to functional magnetic resonance imaging and positron emission tomography neuroimaging.~   "
132299|NCT01835639|"~     This multi-site, pilot study will assess vitamin D supplementation in children and young~     adults with Glomerular Disease. .~   "
132304|NCT01835574|"~     HIV risk among female entertainment and sex workers (FESW) remains high and use of~     amphetamine-type stimulants (ATS) significantly increases this risk. We designed a cluster~     randomized stepped wedge trial: The Cambodia Integrated HIV and Drug Prevention~     Implementation [CIPI) study. The CIPI study is embedded within the SMARTgirl HIV prevention~     program. The CIPI study aimed to recruit FESW from 10 provinces, assessing HIV risk exposures~     including ATS use. The CIPI study then tested sequentially delivered, behavioral~     interventions targeting ATS use. The trial combines a 12-week Conditional Cash Transfer (CCT)~     intervention with four-weeks of cognitive-behavioral group aftercare (AC) among FESW who use~     ATS. The primary goal of the CIPI study is to reduce ATS use and unprotected sex among FESW.~     The CCT+AC intervention is being implemented in ten provinces where order of delivery was~     randomized. Outcome assessments (OEs) including biomarkers and self-reported measures of~     recent sexual and ATS use behaviors are conducted prior to implementation, and at three~     6-month intervals after completion. All women who are ATS negative at 6-months, including~     those who have completed the CCT+AC intervention are eligible to participate in a~     micro-enterprise (ME) opportunity. Consultation with multiple groups and stakeholders on~     implementation factors facilitated acceptance and operationalization of the trial.~     Statistical power and sample size calculations were based on expected changes in ATS use and~     unprotected sex at the population level as well as within-subjects. Dissemination of process~     indicators during the multi-year trial is carried out through annual in-country Stakeholder~     Meetings. Provincial 'Close-Out' forums are held at the conclusion of data collection in each~     province. When analysis is completed, dissemination meetings will be held in Cambodia with~     stakeholders, including community-based discussions sessions, policy briefs, and results~     published and presented in the HIV prevention scientific journals and conferences. CIPI is~     the first trial of an intervention to reduce ATS use and HIV risk among FESW in Cambodia.~     Results will inform both CCT+AC implementation in low and middle-income countries and~     programs designed to reach FESW.~   "
132305|NCT01835561|"~     This study is for research purposes only and will not treat any disease or condition you may~     have. The study is an open label and single dose study; open label means that you, the study~     doctor and study staff will know which study drug you are taking.~      The purpose of this research study is to compare drug levels in the body of people with liver~     disease to drug levels in healthy people with a normal liver. In addition, the safety of the~     study drug will be studied. Information about any side effects (discomfort or decline in~     health) that may happen will be collected. The study drug will be given by mouth to subjects~     with liver disease and to healthy subjects.~      In the body, drugs are normally removed by the liver with a smaller amount being removed by~     the kidneys. When the liver is not working as well as it should, the body may not be able to~     remove drugs from the body quickly.~      The information from this study will be used to decide if the drug is safe in subjects with~     liver disease or if a lower dose of the study drug would be safer.~   "
132306|NCT01835548|"~     This is a randomized, double-blind, placebo-controlled, parallel group, Phase 3 trial to~     evaluate the safety and efficacy of NT0102 in the treatment of Attention Deficit~     Hyperactivity Disorder (ADHD) in pediatric patients 6 to 12 years of age in a laboratory~     classroom study.~   "
132307|NCT01835535|"~     The TIVUS II is a prospective, multicenter, non-randomized, open-label clinical study of the~     safety and performance of the TIVUS™ System consisting of three (3) concurrent cohorts:~        -  TIVUS™ Severe Resistant HTN Cohort~        -  TIVUS™ Moderate Resistant HTN Cohort~        -  TIVUS™ Failed RF Therapy Cohort~   "
132308|NCT01835522|"~     The goal of this study is to survey patients with a diagnosis of schizophrenia to determine~     if there is a relationship between self-reported sexual function and treatment with~     antipsychotic medication.~      Hypotheses: 1. Patients on typical antipsychotics will rate their sexual function as lower~     than those on atypical agents. 2. Patients on multiple antipsychotics will rate their sexual~     function as lower than those on a single agent.~   "
132309|NCT01835509|"~     The primary aim of this randomized, controlled study is to evaluate the impact and~     feasibility of a prolonged physical activity intervention in school-aged childhood cancer~     survivors who self-report sedentary lifestyles. The study will test the hypothesis that~     childhood cancer survivors participating in a physical activity intervention guided by Social~     Cognitive Theory will increase the amount of time spent daily in moderate to vigorous~     physical activity, and improve exercise self-efficacy compared to children randomized to~     usual care. A secondary aim is to assess the impact of the intervention on cardiovascular~     risk factors including fitness and body composition.~   "
132310|NCT01835496|"~     The objective of this study is to evaluate the pharmacokinetics of deferiprone and its~     3-O-glucuronide metabolite following administration of a single 1500 mg dose of Ferriprox in~     patients with sickle cell disease.~   "
132311|NCT01835483|"~     To establish the overall agreement of the MassPLEX Factor II and Factor V Leiden Genotyping~     Test with bi-directional DNA sequencing for Factor II and Factor V Leiden.~   "
132312|NCT01835470|"~     The purpose of this study is to assess the efficacy of Abatacept after intravenous~     administration in Japanese children and adolescents with active juvenile idiopathic arthritis~     who have a history of an inadequate response or intolerance to Methotrexate or biologics~   "
132313|NCT01835457|"~     Auto-immune diseases are characterized by an inappropriate inflammatory response against~     tissues in the body and represent a major health care burden. Pro-inflammatory cytokines such~     as TNF-α, IL-6 and IL-1β play a central role in the pathophysiology of many auto-immune~     diseases. Innovative therapies aimed at limiting pro-inflammatory cytokine production in a~     more physiological manner are warranted. In previous research conducted in an individual~     known as the iceman, the investigators found that, through a autodidact~     concentration/meditation technique, he appears to mount a controlled stress response,~     characterized by activation of the sympathetic nervous system and enhanced production of~     cortisol, both of which are known to result in immunosuppression. In accordance, while~     practicing this concentration/meditation technique, the inflammatory response during human~     endotoxemia (lipopolysaccharide [LPS] administration) was remarkably low in this individual.~     Therefore, this technique could provide a novel means of controlling the inflammatory~     response. However, the aforementioned results were obtained in just one subject, and hence~     can not serve as scientific evidence for the effectiveness of the concentration/meditation~     technique. The iceman claims that he can teach this technique to other subjects within a~     relatively short time frame. Therefore, in the present study the investigators wish to~     investigate the effect of concentration/meditation on autonomic nervous system activity and~     the inflammatory response during experimental human endotoxemia in a controlled manner, by~     comparing a group of subjects that are trained by the iceman and practice the~     concentration/meditation technique with a group of subjects which do not.~   "
132396|NCT01834352|"~     The purpose of this study is to determine if walnut oral immunotherapy can be used in~     subjects allergic to tree nuts to decrease their tree nut allergy and induce changes in their~     immune system.~   "
132314|NCT01835444|"~     Reallocation of healthcare is one solution to the problems healthcare is facing. In the~     Netherlands reallocation of care to Physician Assistants (PAs) hasn't adequately been~     studied. Given the growing number of PAs, it is essential to evaluate the effectiveness and~     efficacy of (Dutch) PA services.~      This multicenter matched-controlled study aims to evaluate the (cost) effectiveness of~     substitution of hospital ward care from medical doctors (MDs) to PAs. The traditional model~     in which the role of house officer is taken by medical doctors MD model) will be compared~     with a mixed model in which a PA functions as house officer together with a medical doctor~     (PA/MD model). Hospital wards will be matched on medical specialism and hospital type (i.e.~     academic;non-academic). On the basis of USA studies, it is hypothesized that the mixed PA/MD~     model compared to the MD model reduces the costs of healthcare, while improving or~     maintaining the clinical outcomes, patients and provider satisfaction, and continuity and~     quality of care.~      Primary research question:~      • What is the effect of 'mixed PA/MD model' compared with 'MD model' on efficiency of care?~      Secondary research questions:~        -  What is the effect of 'mixed PA/MD model' compared with 'MD model' on clinical and~          patients outcomes?~        -  What is the effect of 'mixed PA/MD model' compared with 'MD model' on continuity of~          care?~        -  What is the effect of 'mixed PA/MD model' compared with 'MD model' on nurses and~          (specialist) medicals doctor experiences?~        -  What are the barriers and facilitating factors considering the implementation of PAs as~          house officer?~   "
132315|NCT01835431|"~     This trial is conducted in Asia, Europe and North and South America. The aim of the trial is~     to investigate the efficacy and safety of insulin degludec/insulin aspart once daily plus~     insulin aspart for the remaining meals in children and adolescents with type 1 diabetes~     mellitus.~   "
132316|NCT01835418|"~     This study seeks to compare the differences in effectiveness among individual patients~     treated at for hypertension with bedtime administration of amlodipine versus lisinopril.~     There will be an analysis of whether one medication was more effective than another and~     whether specific patient factors could predict who responded better to which one.~   "
132317|NCT01835405|"~     To evaluate the cosmetic outcome, effectiveness, user and subject satisfaction, and safety of~     LiquiBand® Flex in relation to DermaBond Advanced™ and conventional sutures for the topical~     closure of surgical wounds.~   "
132318|NCT01835392|"~     The purpose of this study is to look at whether the use of a simple technique before surgery,~     which involves inflating a blood pressure cuff on the infant's leg, can improve development~     of language, motor and thinking skills at 12 months of age. Some research has found that a~     brief shortage of blood supply to an organ (such as a leg) at level that does not cause harm~     may help the body to tolerate a longer and more severe shortage of blood (for example, during~     surgery).~   "
132319|NCT01835379|"~     Many people with diabetes will develop a non-healing diabetic foot ulcer. Many ways are~     available to try to get a diabetic foot ulcer to heal, including application of Oasis Ultra.~     The hypothesis to be tested is that application of Oasis Ultra will cause more diabetic foot~     ulcers to heal than wounds treated with regular medical care. Subjects will have their~     diabetic foot wounds treated for up to 12 weeks with Oasis Ultra or regular medical care .~   "
132320|NCT01835353|"~     This is a prospective, multi-center, non-randomized, controlled study in 2 sequential groups~     of P2Y12 inhibitor-naive consecutive STEMI patients undergoing primary PCI. Following aspirin~     325 mg LD, patients will receive 60 mg or 100 mg of prasugrel, respectively. Platelet~     reactivity (PR)will be assessed at Hour 0 (before prasugrel's administration immediately~     prior to PCI) and at Hours 0.5, 1, 2, 4 thereafter. Platelet function testing (in PRU) will~     be performed with the VerifyNow (Accumetrics Inc., San Diego, CA, USA) P2Y12 function assay.~   "
132321|NCT01835340|"~     Propofol can be measured continuously in breath gas during anesthesia. This study compares~     propofol concentration in plasma and breath gas and processed electroencephalographic~     monitoring (bispectral index) under clinical conditions with patients and total intravenous~     anesthesia. Target controlled infusion technique is used to deliver adequate propofol~     concentration in plasma.~   "
132322|NCT01835327|"~     The current study proposes to address the question of whether patients' cerebral oxygen~     saturation levels are predictive of their recovery from thoracic surgery. Further, the study~     poses the hypothesis that a patient's poor recovery status goes on to increase a patient's~     risk of developing post-operative morbidities such as pneumonia, arrhythmias and delirium.~     The aim of this study is to address the observation that some patients struggle more than~     others in their recovery and that 1) this may be a result of intraoperative cerebral oxygen~     desaturations and 2) that this may affect their post-operative morbidity. If a potential~     means of predicting poor outcomes is identified this will lead to further research into how~     to adjust the associated variables, such as cerebral oxygenation, to improve patient~     post-operative outcome.~   "
132323|NCT01835314|"~     Compassionate use of Stiripentol in Dravet Syndrome. This is a treatment protocol, not a~     research study, therefore children will only be monitored on a clinical basis for seizure~     improvement predominantly by parent and caregiver report.~   "
132324|NCT01835301|"~     This study aims to test the hypothesis that plaque composition differs within a stent between~     bare metal stents and drug eluting stents (DES). It is possible that a difference in plaque~     composition seen within a stent may be contributory to the late thrombotic events seen more~     frequently with DES.~   "
132325|NCT01835288|"~     This phase II trial studies how well arsenic trioxide works in treating patients with~     relapsed or refractory acute myeloid leukemia. Drugs used in chemotherapy, such as arsenic~     trioxide, work in different ways to stop the growth of cancer cells, either by killing the~     cells or by stopping them from dividing.~   "
132326|NCT01835275|"~     The purpose of this study is to determine whether enhanced audio methods can be used to~     improve analgesia for experimental pain in healthy subjects.~   "
132327|NCT01835262|"~     The primary objectives of the study are to evaluate the efficacy of subdissociative dose~     intravenous ketamine compared with intravenous morphine in relieving acute pain in the ED.~     Secondary objectives will include the rate of adverse effects and need for rescue analgesia.~     The hypothesis is that intravenous administration of subdissociative dose ketamine at 0.3~     mg/kg is superior to intravenous morphine at 0.1mg/kg in treating moderate and severe acute~     pain in patients presenting to the ED.~   "
132328|NCT01835249|"~     Hypertension is a major risk factor for cardiovascular and renal disease, and a leading cause~     of premature mortality worldwide. Early hypertension studies showed that treating elevated~     blood pressure (BP) reduces patients' risk of cardiovascular disease and all-cause mortality.~     In subsequent research, patients achieved greater improvement in cardiovascular outcomes when~     their treatment was aimed at a moderate systolic BP target (<150mmHg) than at higher targets.~     Although observational data suggest that even lower BP targets may be beneficial, this has~     not been seen in randomized trials; instead, intense treatment of hypertension (i.e., to a~     target systolic BP <120mmHg) was found to have no effect on participants' risk for renal~     disease, cardiovascular disease, or all-cause mortality.~      One potential explanation for this apparent lack of benefit of intense BP targets is that the~     study protocols targeted reductions in clinic BP rather than ambulatory BP. Ambulatory BP~     monitoring (ABPM) allows for assessment of BP throughout the day and night. Of all the BP~     measurements, nighttime systolic BP appears to be the best predictor of cardiovascular~     disease and all-cause mortality. Because recent trials assessing intense BP targets did not~     include ambulatory BP measurements, the effect of intensive treatment on nighttime BP is~     largely unknown.~      To address this important gap in knowledge, we will conduct ABPM in 600 participants as part~     of an ancillary study to the ongoing Systolic Blood Pressure Intervention Trial (SPRINT). The~     goal of the ancillary study is to evaluate the effect of intensive vs. standard clinic based~     BP targets on nighttime BP (primary outcome), as well as night/day BP ratio, timing of peak~     BP, 24hr BP, and BP variability (secondary outcomes). The SPRINT trial includes approximately~     9250 participants at high risk for cardiovascular disease.~      The investigators hypothesize that intense targeting of clinic systolic BP does not lower~     nighttime systolic BP compared to a standard target.~   "
132329|NCT01835236|"~     In HER2-positive metastatic breast cancer, trastuzumab based treatment is the standard of~     care as long as there are no contraindications to trastuzumab. Frequently, trastuzumab is~     being combined with taxanes in the first-line setting. However, since therapy with~     trastuzumab is active even in the absence of chemotherapy in HER2-positive MBC, the optimal~     treatment strategy either in combination or in sequence with chemotherapy is still under~     debate. This randomized phase II trial is studying a new strategy for the treatment of~     metastatic breast cancer with HER2-positive. First-line treatment consists of trastuzumab and~     pertuzumab, a treatment without chemotherapy. In case of disease progression, chemotherapy~     with T-DM1 is then performed as second-line treatment. Third-line and further line therapies~     are performed according to the physician's discretion. If this new therapeutic strategy is as~     effective and better tolerated than the conventional strategy, this would mean a serious~     breakthrough in the treatment of HER2-positive metastatic breast cancer.~   "
132330|NCT01835223|"~     This phase I/II trial studies the side effects and best dose of tivozanib and to see how well~     it works in treating patients with liver cancer that has spread to other parts of the body or~     cannot be removed by surgery. Tivozanib may stop the growth of tumor cells by blocking some~     of the enzymes needed for cell growth.~   "
132331|NCT01835210|"~     Acne vulgaris is a common problem in the adolescent community. Past research has shown that~     acne affects teenager's self-esteem and mood. However, no research has evaluated the parent~     perception of their teenager's acne in comparison to the severity of acne and the patient's~     own reported quality of life. It is hypothesized that parents of teenagers underestimate how~     much acne vulgaris affects their teenager's skin disease-related quality of life. Also that~     teenager's perception of the severity of their acne is greater versus their parent's~     perception. We believe that increased acne severity based on clinician assessment will~     correlate with worse quality of life. Teenagers between 12 and 17 years old with a diagnosis~     of acne by a pediatric dermatologist will be enrolled in this study. The study consists of 1~     visit, questions regarding demographics, assessment of the teen's acne, the Skindex-Teen~     quality of life survey (modified for parents), and 2 Likert scales will be completed. In~     addition, the clinician will score the teen's acne using the standardized Investigator Global~     Assessment tool. Statistical analysis will compare teen subject answers to the Skindex-Teen~     with their parent's answers. Also analyzed will be the severity of acne and differences~     between the clinician IGA score and Skindex-Teen responses~   "
132332|NCT01835197|"~     This single- and multiple-ascending dose study is the first evaluation of PF-04965842, a~     Janus kinase1 (JAK1) inhibitor, in humans. The goal is to assess the safety, tolerability,~     pharmacokinetics and pharmacodynamics in healthy Western and Japanese subjects.~   "
132333|NCT01835184|"~     This phase I trial studies the side effects and best dose of cabozantinib-s-malate when given~     together with vemurafenib in treating patients with solid tumors or melanoma that is~     metastatic or that cannot be removed by surgery. Cabozantinib-s-malate and vemurafenib may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~   "
132334|NCT01835158|"~     This randomized phase II trial studies how well cabozantinib-s-malate works compared to~     sunitinib malate in treating patients with previously untreated kidney cancer that has spread~     from where it started to nearby tissue or lymph nodes or to other places in the body.~     Cabozantinib-s-malate and sunitinib malate may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth. It is not yet known whether cabozantinib-s-malate~     is more effective than sunitinib malate in treating patients with kidney cancer.~   "
132335|NCT01835145|"~     This randomized phase II trial studies how well cabozantinib-s-malate works compared with~     temozolomide or dacarbazine in treating patients with melanoma of the eye (ocular melanoma)~     that has spread to other parts of the body and cannot be removed by surgery.~     Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as temozolomide and dacarbazine,~     work in different ways to stop the growth of tumor cells, either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading. It is not yet known whether~     cabozantinib-s-malate works better than temozolomide or dacarbazine in treating patients with~     melanoma of the eye.~   "
132336|NCT01835132|"~     Background:~      - Scleritis is the inflammation of the white outer coating of the eye, known as the sclera.~     In severe cases, it can cause blindness. It is commonly associated with autoimmune disorders~     such as rheumatoid arthritis. Mild scleritis can be treated with drugs such as ibuprofen.~     More severe scleritis may need oral steroids or immunosuppressive treatments; however, these~     treatments can cause side effects in the whole body. Gevokizumab is a newer anti-inflammatory~     drug that is under investigation to treat other inflammatory diseases. It may not have as~     severe side effects as some other drugs. However, it has not yet been used to treat~     scleritis. Researchers want to see if it can be given as a safe and effective treatment for~     scleritis.~      Objectives:~      - To see if gevokizumab is a safe and effective treatment for scleritis.~      Eligibility:~      - Individuals at least 18 years of age who have active scleritis.~      Design:~        -  There is an initial phase and a two-part extension phase in this study. The extension~          phase is optional. The initial phase of the study requires seven visits to the National~          Eye Institute (NEI).~        -  Participants will be screened with a physical exam and eye exam, and medical history~          will be obtained. Blood and urine samples will be collected.~        -  Eligible participants will receive an injection of 60 mg of gevokizumab at the first~          study visit and at Weeks 4, 8, and 12. They will be given under the skin by the stomach,~          or in the upper arm or thigh.~        -  Participants will have additional visits after the first study visit at Weeks 2, 16, and~          28. No injection will be given at these visits. Eye exams will be done, and blood and~          tear samples will be collected.~        -  If the scleritis improves by Week 16, participants may choose to continue the study in~          the extension phase. In the 1st extension, they will have a visit every 4 weeks until~          Week 36 and then two additional monitoring visits at Weeks 40 and 52 for a total of 13~          study visits.~        -  Participants who are eligible at Week 52 may continue in the as needed (PRN) extension~          phase (2nd extension) and receive gevokizumab injections (60 mg) at Weeks 52, 54, 58 and~          62.~   "
132337|NCT01835119|"~     Postoperative ileus can cause the accumulation of secretions and gas, resulting in nausea,~     vomiting and abdominal distension and pain. Prolonged paralytic ileus is one of the commonest~     reasons for delayed recovery and discharge from hospital following abdominal surgery.~     Advances in surgical techniques and peri-operative management such as the use of laparoscopic~     surgery, thoracic epidural analgesia, early postoperative feeding and mobilization, amongst~     others, have been shown to help in the resolution of postoperative ileus.~      Chewing gum, as a proxy for sham feeding, may accelerate the motility of the GI tract by~     stimulating the cephalic phase of digestion and eliciting the release of multiple promotility~     GI hormones. A number of small controlled studies evaluating the effect of chewing gum on~     postoperative intestinal recovery in patients undergoing colorectal surgery have been~     conducted. Decreased time for bowel function recovery and decreased hospital length of stay~     have not been consistently documented, possibly owing to the insufficient power of existing~     studies and study design issues. In addition, all previous studies have been limited by their~     use of sugarfree gum, containing known motility agents (eg, sorbitol).~      In this study, gum chewing was studied for its effect on women with surgical staging for~     malignant gynecologic disease such as endometrial cancer, cervix cancer and ovarian cancer.~   "
132338|NCT01835106|"~     The investigators are investigating two ways of treating pain after hip surgery. One way is~     though a thin tube (called a catheter), and it is placed into the back so that pain-numbing~     drugs can reach the nerves near the backbone. This is called an epidural catheter. Another~     way is to place the catheter close to the hip, where the surgery is done, so that the~     pain-numbing drugs can reach some of the nerves more locally. This is called a fascia iliaca~     compartment catheter.~      The investigators do not know which way is best to treat pain, or has fewer side effects, or~     allows a patient to leave hospital faster. Usually, patients would receive only one type of~     catheter for pain relief. To do this comparison, the investigators would place both catheter~     types, so that patients help us tell which one works better.~   "
132339|NCT01835093|"~     Accumulating evidence suggests a role of G protein-coupled inwardly-rectifying potassium~     (GIRK) channel in the pathology of excitement of nerve, and the medicine with the action~     (like the Tipepidine Hibenzate) is expected as a new curative medicine of Attention Deficit /~     Hyperactivity Disorder (AD/HD).~      The purpose of this research is to confirm the effect by carrying out the additional dosage~     of the Tipepidine Hibenzate to the AD/HD patients.~      If suggestion is obtained by this research about the effect on AD/HD of Tipepidine Hibenzate,~     it can contribute to development of the medical treatment of AD/HD.~   "
132340|NCT01835080|"~     The purpose of this study is to determine whether pulmonary arterial hypertension can worsen~     or even cause sleep apnea. It is hypothesized that if pulmonary arterial hypertension does~     indeed worsen or cause sleep apnea, then the treatment should first focus on the underlying~     pulmonary arterial hypertension instead of the sleep apnea.~      To determine if a person has sleep apnea, they will undergo one overnight polysomnogram~     (sleep study). If it is found that they have mild to moderate sleep apnea, then the subject~     will be invited to continue in the study and their pulmonary arterial hypertension will be~     treated by their managing primary physician. After the subject has had treatment for their~     pulmonary arterial hypertension, the study center will have them return for a follow up sleep~     study to learn the effects of pulmonary arterial hypertension treatment management on their~     sleep apnea, 12-24 weeks after the first sleep study.~   "
132341|NCT01835067|"~     This study will recruit patients who have recently had a submacular haemorrhage (bleed under~     the part of the retina responsible for detailed vision), as a complication of wet age-related~     macular degeneration (wet AMD). Wet AMD is a very common disease where abnormal blood vessels~     form under the retina and leak, causing a significant reduction in vision.~      The study will investigate treatment of the bleed with various combinations of the two drugs:~     tissue plasminogen activator (tPA) - designed to dissolve the blood clot; and~     perfluoropropane (C3F8) - designed to shift the blood clot away from the central part of the~     retina (the macula). tPA is a commonly used 'clot-buster' drug for the treatment of stroke.~     C3F8 is a gas commonly used in eye surgery. Patients recruited will be divided into four~     groups: control group that receive none of the above drugs; one group that receives only tPA;~     one group that receives only C3F8; and one group that receives both.~      All patients will receive the current gold standard treatment for wet AMD, ranibizumab~     (Lucentis®).~      The aim of the study is to improve vision in a condition, which left untreated, would cause~     severe visual loss.~   "
132342|NCT01835054|"~     Mitral regurgitation (MR) is one of the most frequent valve lesions, both in North America~     and in Europe, and its prevalence is increasing with the aging of the population. Organic~     Mitral Regurgitation (OMR) and Ischemic Mitral Regurgitation are the 2 main categories of MR.~     Organic or primary MR is caused by an anatomic alteration of the valvular or subvalvular~     mitral apparatus and refers to rheumatic MR and degenerative MR that includes mitral leaflet~     prolapse and flail leaflet. In the past 20 years, degenerative MR has become, by far, the~     most frequent cause of severe MR leading to surgery in the western world. However, the best~     current treatment for OMR remains uncertain and controversial. We have obtained preliminary~     data showing that OMR is a dynamic lesion. Hence, the echocardiographic evaluation of MR at~     rest, as generally performed during routine clinical exam, does not necessarily reflect the~     status of MR during patient's daily activities and thereby does not adequately assess the~     risk of rapid progression and poor outcome in these patients. The objective of this study is~     to identify the independent predictors of disease progression and outcome in patients with~     asymptomatic chronic OMR and to develop and validate novel imaging and circulating biomarkers~     to improve risk stratification and therapeutic decision-making process in patients with~     chronic asymptomatic primary OMR.~   "
132343|NCT01835041|"~     This phase I trial studies the side effects and best dose of CPI-613 when given together with~     combination chemotherapy in treating patients with metastatic pancreatic cancer. Drugs used~     in chemotherapy, CPI-613, leucovorin calcium, fluorouracil, irinotecan hydrochloride, and~     oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing.~   "
132397|NCT01834339|"~     The purpose of this study is to compare the safety and effectiveness of performing oral~     reconstructive surgeries using either AlloDerm, a product commonly used for this purpose, or~     AlloDerm that has been overlaid with the subject's oral mucosal cells and developed into a~     type of graft that is called an ex vivo produced oral mucosal equivalent, EVPOME.~   "
132344|NCT01835028|"~     Low-flow, low-gradient (LF-LG) aortic stenosis (AS) may occur with depressed (i.e. Classical~     LF; CLF) or preserved (i.e. Paradoxical LF; PLF) LV ejection fraction (LVEF) and both~     situations are amongst the most challenging encountered in patients with valvular heart~     disease. Although, CLF-LG AS is recognized has an important clinical entity, current~     ACC/AHA-ESC guidelines however do not provide precise recommendations for clinical management~     of these patients . PLF-LG AS is a new entity recently described by our group, which is~     characterized by more pronounced LV concentric remodeling with smaller LV cavity size and a~     restrictive physiology leading to impaired LV filling, altered myocardial function, and a~     low-flow state. Up to recently, this entity was often misdiagnosed, leading to~     underestimation of AS severity and inappropriate delays for aortic valve replacement surgery~     (SAVR). The two main challenges in patients with CLF- or PLF- LG AS are to distinguish~     between a true-severe (TS) versus a pseudo-severe (PS) stenosis and to accurately quantify~     the extent of myocardial impairment. Unfortunately, the traditional resting and stress~     echocardiographic parameters currently used to assess the severity of valvular and myocardial~     dysfunction in patients with LF-LG AS are far from being optimal, and as a consequence,~     quantification of disease severity and therapeutic management may not be appropriate in a~     substantial proportion of these patients.~      THE GENERAL OBJECTIVES of the TOPAS study are to develop and validate new parameters and~     biomarkers to improve the assessment of stenosis severity and myocardial impairment, the~     risk-stratification, and the clinical decision making in patients with LF-LG AS and to assess~     the impact of the different therapeutic strategies on patient outcomes.~   "
132345|NCT01835015|"~     The purpose of this study is to evaluate the safety, tolerability, and serum pharmacokinetics~     of CLG561 in subjects with advanced age-related macular degeneration (AMD).~   "
132346|NCT01835002|"~     The purpose of this study is to determine the long term effects of transcorneal~     electrostimulation (TES) in patients with retinitis pigmentosa (RP). In a prior study~     (NCT00804102) the results of short term stimulation pointed to a positive effect on the~     visual field and other parameters. In this study, the patients will be stimulated with the~     OkuStim device for half a year and safety parameters will be measured.~   "
132347|NCT01834989|"~     The purpose of the study is to test the hypothesis that stimulation of the synthesis of new~     structural tendon proteins combined with training improve the tendon structure in patients~     with chronic knee tendon pain.~   "
132348|NCT01834976|"~     The purpose of this study is to investigate cardiac biomarker during perioperative management~     in pediatric cardiac surgery.~   "
132349|NCT01834963|"~     To evaluate the efficacy and safety of postoperative hepatic arterial infusion chemotherapy,~     interferon/fluorouracil versus low-dose cisplatin/fluorouracil, in patients with~     hepatocellular carcinoma with portal vein tumor thrombus.~   "
132350|NCT01834950|"~     The study is a single arm prospective study, aiming at identifying biomarkers of early~     response to trastuzumab. It is a prognostic factor study recruiting all consecutive cases of~     HER-2 positive breast cancer eligible for a pre-operative treatment by trastuzumab, followed~     by breast conserving surgery. The investigators will study the association between the value~     of biomarkers measured at diagnosis and the Response Evaluation Criteria in Solid Tumors~     response (partial and complete response) using a logistic regression (main analysis).~   "
132351|NCT01834937|"~     The purpose of this enhanced surveillance study (ESS) is to collect information regarding~     chronic adverse events that are possibly related to the ExAblate® System (ExAblate) that~     are received by InSightec (InSightec) following PMA approval. This study will examine~     adverse events reported in patients undergoing the device procedure for the first two years~     of commercial experience. Other relevant data may be collected as well.~   "
132352|NCT01834924|"~     Almost half of all US adults have trouble understanding and using health information, or low~     health literacy. Health literacy is considered to be an important patient safety issue, and~     has been linked to poor medication management. Low health literacy is a risk factor for~     parent errors in administering medications to their children; difficulty understanding~     provider medication instructions is likely to contribute to errors.~      To address these issues, bilingual (English/Spanish), low literacy, picture-based medication~     instruction sheets were developed. This study will look at the effectiveness and feasibility~     of the medication instruction sheet-based intervention as it is used by providers in 2~     pediatric emergency department settings, as part of a planned roll out of HELPix within the~     hospital system. The investigators hypothesize that there will be reduced medication dosing~     errors, improved medication adherence, reduced hospital revisit rates, and improved~     provider-parent communication. The investigators also hypothesize that provider technology~     experience, knowledge, and attitudes, will affect the extent to which providers use the tool.~   "
132353|NCT01834911|"~     Tetrabenazine has been shown to improve gating of abnormal visual stimuli and improve~     postural stability in Huntington disease (HD) patients as measured by computerized dynamic~     posturography testing. This study aims to elucidate whether partial dopaminergic depletion~     via low dose tetrabenazine has a similar effect on masking out of abnormal visual stimuli on~     the Stroop interference test.~   "
132354|NCT01834898|"~     The hypothesis of this study is that controlled release oxycodone can be safe and well~     tolerated for the control of postoperative pain in surgery for head and neck cancer. The~     primary objective is to study the safety and the incidence and severity of adverse effects,~     and the secondary objective is to evaluate the analgesic efficacy and identify the frequency~     of use of rescue medication and the prescribing physician's opinion about the quality of~     postoperative analgesia with oxycodone controlled release in oncologic surgery of the head~     and neck.~   "
132355|NCT01834885|"~     Study is to show that QVA149 is superior to the standard of care, fluticasone/salmeterol, in~     patients with moderate to severe airflow limitation~   "
132356|NCT01834872|"~     The aim of this prospective observational study is to evaluate the performance of Amigo RCS~     in ablation procedures for most common arrhythmias as compared to a conventional manual~     approach.~   "
132398|NCT01834326|"~     The purpose of this study is to improve the current standard of care of repairing mouth soft~     tissue defects.~   "
132399|NCT01834313|"~     The purpose of this study is to evaluate the monetary value of patient-centrednes in health~     care by determining a willingness-to-pay for more patient-centredness care for both patients~     and health insurers~   "
132357|NCT01834859|"~     Very-low calorie diets are relatively safe and effective in inducing significant weight loss,~     when used in selective individuals and under clinical supervision. However, weight loss~     maintenance in the long-term remains the main challenge, with many experiencing a significant~     weight regain. Several compensatory mechanisms are activated under weight reduction, both at~     the level of energy intake (such as increased appetite) and energy expenditure (such as~     reduced energy expenditure), and increase the risk of relapse.~      The main aim of this study is to compare the effect of two multidisciplinary lifestyle~     interventions on weight loss maintenance at one year, after initial weight loss during 8~     weeks very-low calorie diet. Participants will be allocated (non-randomly) to either an~     outpatient program in the obesity unit of the local hospital, or to an inpatient program~     consisting of a continuous care intervention, with three intermittent stays (each with~     three-week duration) in a rehabilitation center over a one year period. Moreover, the~     investigators aim to assess the impact of weight loss (achieved with a very low calorie diet)~     and weight loss maintenance on compensatory mechanisms activated during weight reduction.~   "
132358|NCT01834846|"~     The success of coronary artery bypass grafting is reliant on the quality of the grafts used.~     A new technique for harvesting veins used as grafts has been introduced. The study hypothesis~     is that veins harvested with this technique have an improved endothelial function.~   "
132359|NCT01834833|"~     Evaluate the benefit of systematic appointment with a cardiologist a week after~     hospitalisation for acute heart failure. Randomised, endpoint: number of day alive out of~     hospital during 6 months~   "
132360|NCT01834820|"~     In infancy, bronchiolitis is the most common acute infection of the lower respiratory Tract.~     The current treatment of bronchiolitis is controversial. Bronchodilators and corticosteroids~     are widely used but not routinely recommended. Hypertonic saline is currently the only drug~     recommended by the Spanish Association of Pediatrics in treatment guidelines.~      The purpose of this study is quantify whether epinephrine, dexamethasone, and hypertonic~     saline are effective to decrease the rate of hospital admissions at seven day, also verify~     adverse effects in patients submitted.~   "
132361|NCT01834807|"~     This retrospective, observational, multi-center study will evaluate the use of biological~     agents (e.g. RoActemra/Actemra [tocilizumab]) in monotherapy in patients with rheumatoid~     arthritis. Data from medical record files will be collected of patients currently treated~     with a biologic in monotherapy.~   "
132362|NCT01834794|"~     This project aims to develop and test an intervention for the simultaneous treatment of~     cannabis use disorders and tobacco smoking. This is important because over 50% of adults~     seeking treatment to help stop cannabis use also smoke tobacco regularly, which decreases~     their chance for a successful treatment outcome and increases adverse acute and long-term~     psychosocial and health consequences. The proposed treatment will integrate existing~     computer-based behavioral interventions for cannabis and tobacco and use nicotine replacement~     medications to improve outcomes in this difficult to treat clinical population.~   "
132363|NCT01834781|"~     The purpose of this study is to determine whether pulsed electromagnetic fields(PEMF) is~     effective in the treatment of multiple chemical sensitivity in terms of life impact,~     symptoms, psychological distress, markers of central sensitization and the immune system, and~     quality of life.~   "
132364|NCT01834768|"~     Kidney transplant recipients usually lose their graft by rejection or by immunosuppressive~     drugs toxicity. In kidney transplantation, calcineurin-inhibitors (including cyclosporine A)~     are widely used. Their renal toxicity could be divided between an acute toxicity (toxic~     arteriolopathy and toxic tubulopathy) and a chronic toxicity (hyaline arteriolopathy,~     interstitial fibrosis, tubular atrophy and glomerulosclerosis). Several animal models have~     shown the implication of the mineralocorticoid receptor (MR) activation in those toxic~     phenomenons. The use of a mineralocorticoid receptor antagonist is useful regarding to the~     renal function and kidney histological damages.~      Several antagonists are available in France but none is indicated in kidney transplantation.~     Eplerenone appears to be the most selective molecule of the mineralocorticoid receptor and to~     have less adverse anti-androgenic effects than others molecules. Its principal adverse events~     are hyperkalemia and orthostatic hypotension. Mineralocorticoid receptor antagonists,~     especially eplerenone, could be very useful in the prevention of the nephrotoxicity induced~     by calcineurin-inhibitors.~      Classically, eplerenone is contra-indicated in patients presenting with an impaired renal~     function, determined by a creatinine clearance under 50mL/min. Moreover, in France, a warning~     is especially notified for the association with cyclosporine A due to the fact that no study~     have been done in this context.~      The investigators study first the safety of the use of eplerenone in association with~     cyclosporine A in kidney transplant recipients. Then, if it is safe, the investigators will~     study its efficiency in a large randomized controlled trial.~   "
132365|NCT01834755|"~     Highlighting the relationship between psychological and physical profiles and patient's~     preference to better understand the patient's treatment preference and improve the~     information provided.~   "
132366|NCT01834742|"~     This study is to investigate the effect of various modified low volume polyethylene glycol~     (PEG) 3350 and ascorbic acid/ascorbate (PEG+ASC)-based gut cleansing solutions on stool~     output in healthy subjects. In addition, the study is to assess and compare the safety and~     tolerance of the modified PEG+ASC formulations following oral administration with the safety~     profile of MOVIPREP®.~   "
132367|NCT01834729|"~     This study is designed to better understand the effects of effects of stress, relaxation, and~     a medication alfuzosin on bowel control and emptying in healthy people and patients with~     bowel problems.~   "
132400|NCT01834300|"~     This project examines the effects of a 4 month structured exercise intervention program in~     patients with non-alcoholic fatty liver disease (NAFLD). We will examine changes in total and~     depot-specific (i.e.in different tissues, liver, muscle and pancreas)fat. We will correlate~     these with measurements of the insulin from the liver. The hypothesis is that by reducing fat~     in these specific depots we can reduce insulin resistance and prevent progression to~     diabetes.~   "
132490|NCT01833130|"~     This study will evaluate the use of the Assessment of Chronic Migraine Impacts (ACM-I)~     Questionnaire in assessing the impact and benefit of treatment with onabotulinumtoxinA~     (BOTOX®) in adults with chronic migraine.~   "
132491|NCT01833117|"~     The purpose of this study was to compare the effect of FID 119515A to Blink® Tears on the~     integrity of tear film in adults with a history of dry eye in both eyes.~   "
132368|NCT01834716|"~     5.4 million Americans have Alzheimer's disease (AD) costing $185 billion annually, while 15~     million caregivers look after these individuals. AD is the sixth leading cause of death, but~     the only one in the top 10 causes that cannot be prevented.~      This study may demonstrate exercise in an amount attainable by many will be preventative in~     asymptomatic individuals including those with brain Abeta deposition already that are at~     impending risk of the disease. Sperling and colleagues(1) coined the research term~     AD-pathophysiological process (abbreviated AD-P) for use in studies such as the intervention~     in this proposal.~      Our long term goal is to assess whether exercise may be preventative of AD at older ages~     (=73, mean=75), when more than 40% of cognitively normal persons have A beta deposits, the~     hallmark of AD pathogenesis, in their brains. In a NIH RO1 grant submission the investigators~     proposed to conduct a partially blinded controlled preventative trial in 150 cognitively~     normal individuals, randomized in a 2:1 ratio to 18 months of moderate aerobic exercise~     versus 18 months of toning and stretching. All persons would have baseline and 18 month brain~     Abeta PET studies. The study was designed to determine whether an exercise intervention in~     persons mean age 75 would lead to decreased brain Abeta accumulation, increased hippocampal~     volume, improved cognition, and improved dementia-related biomarkers compared to the control~     group. The study would be unique in that the investigators would be able to examine if~     aerobic exercise slows the accumulation of brain Abeta in an older population, at which time~     Abeta deposition is common. If successful, this would provide an additional motivating reason~     to recommend exercise for most elderly persons.~   "
132369|NCT01834703|"~     This study aimed to evaluate the clinical effectiveness and adverse effects of Uterine Artery~     Embolization (UAE), High-Intensity-Focused-Ultrasound (HIFU) in treating patients with~     uterine fibroid.~   "
132370|NCT01834690|"~     Conventionally, the outcome of liver transplantation is usually reported in terms of graft~     and patient survival, medical and surgical complications, but lack of health-related quality~     of life (HRQOL) that might be associated with immunosuppression complications (e.g.,~     diabetes, hypertension, dyslipidemia, obesity, metabolic syndrome, cardiovascular disease,~     renal dysfunction, osteoporosis, and de novo malignancy), disease recurrence, and rejections~     after transplantation.~   "
132371|NCT01834677|"~     The purpose of this study is to evaluate the psychometric properties and utility of new,~     computerized, neurocognitive measures in humans with depression, and humans with depression~     undergoing electroconvulsive therapy (ECT). The benefits of the study outweigh the risk as~     there is the possibility of developing better computerized neurocognitive measures, and the~     risks are limited to no more than minimal test related fatigue and psychological stress.~      Depressed humans, depressed human participants undergoing ECT, and humans diagnosed with~     Parkinson's disease (age 18-85) will be invited to participate in this study. After providing~     informed consent participants will undergo a clinical psychiatric evaluation to confirm the~     inclusion/exclusion criteria. After the clinical psychiatric evaluation, participants will~     complete common and new neurocognitive measures. There will be a total of two testing visits~     (baseline, 1-month follow-up). The anticipated duration of the participant's involvement is~     no more than 2 study visits that can take place over a 4-day period (i.e., the clinical~     evaluation can occur on day 1 and the neuropsychological measures can be administered on day~     2 of each study visit) equating to approximately 6-hours (3-hours each day) per study visit.~   "
132372|NCT01834664|"~     This Study is Single arm, Single Centre trial to study the safety and efficacy of bone marrow~     derived autologous mononuclear cells (100 millions per dose)study enrollment duration 36~     months sample size 100 patients should be treated (above 15 years of age) with cerebral palsy~     in India. Primary outcome measures are improvement in walking ability and kinetic gait~     pattern.~   "
132373|NCT01834651|"~     This research study is being done to measure the clinical benefit associated with~     cabozantinib (XL184) in men who have prostate cancer that has spread to visceral organs~     (organs other than bone or lymph nodes) and no longer responds to initial hormonal~     (castration) therapy. This type of prostate cancer is called metastatic, castrate-resistant~     prostate cancer.~   "
132374|NCT01834638|"~     This is a study of ABT-126 in the treatment of cognitive impairment associated with~     schizophrenia (CIAS), a long-term extension study to study M10-855 (NCT01655680).~   "
132375|NCT01834625|"~     In this pilot study the investigators shall prospectively in a blinded fashion evaluate with~     Aβ PET in patients committed to shunt surgery and then investigate the relationship of these~     biomarkers with outcome on gait, cognition and urinary control improvement in the short term~     (3 months) and long term (1 year). The imaging agent will be provided by AVID.~      Furthermore the study will standardize imaging studies using florbetapir F 18 PET to provide~     information on amyloid burden.~   "
132376|NCT01834612|"~     To determine if a manual blood loss can be detected using the non-invasive blood monitor.~   "
132377|NCT01834599|"~     To assess the potential of the cerebral oximeter to measure placental oxygenation~   "
132378|NCT01834586|"~     The purpose of this study is to see if applying an anesthetic topical adhesive, Synera®, will~     reduce the injection pain. Relieving injection site pain may improve the tolerability of~     Multiple Sclerosis medications.~      Study Hypothesis: Pre-medication with Synera will have a significant effect on pain ratings~     as measured by the visual analog scale and Local injection site reaction scale.~   "
132379|NCT01834573|"~     Patients with inflammatory bowel disease (IBD) suffer from a diminished quality of life~     compared to healthy adults. This is due to the chronic course of disease accompanied with~     diarrhea, stomach pains but also with psychological stress.~      It is known that physical education may improve course of disease and quality of life in a~     multitude of diseases. These include coronary heart disease, malignancies and also~     depression. The investigators believe that sport is as effective supportive tool in improving~     quality of life in IBD patients. But data is lacking with regard to controlled randomized~     clinical trials. Because of the small amount of data available the investigators considered a~     feasibility study. Our hypothesis is that IBD patients will cope with moderate exercise. The~     investigators further suspect that these patients improve their quality of life compared with~     patients in the control group.~   "
133588|NCT01818726|"~     To evaluate Exjade efficacy and safety in patients with aplastic anemia and~     transfusion-dependent iron overload, undergoing treatment programs of immunosuppressive~     treatment (Cyclosporine A) , in comparison with a group of patients undergoing treatment~     programs of immunosuppressive treatment (Cyclosporine A) without chelation therapy.~   "
132380|NCT01834560|"~     Despite the availability of several treatments, a number of patients with major depression~     are refractory to therapeutical approaches and therefore suffer from chronic handicap. For~     these severe patients, neurosurgical therapies can be envisaged. They aim at interrupting~     bundles that link the orbitofrontal cortex with striatum and can therefore benefit for the~     patients.~      This study intends to repeat Dr. Lozano's study, published in 2005 in the journal Neuron. In~     this study, they performed a preliminary evaluation of chronic deep brain stimulation (DBS)~     of the subgenual cingulate region (Brodmann area 25) to treat refractory depression as an~     alternative to subcaudate tractotomy. This last technique was employed in Grenoble in the 60s~     with satisfying results before neurosurgery for psychiatric disorders was abandoned. Since~     1992, psychosurgical therapies that respect ethical recommendations have regained interest to~     treat highly impaired patients. Before the investigators can propose deep brain stimulation~     of subgenual cingulate brain region as a new therapeutic approach for the investigators~     patients in Grenoble, the investigators decided to reproduce their clinical evaluation on a~     group of 6 patients, repeating their methodology faithfully. Therefore nothing was changed to~     the model used by Drs. Lozano and Mayberg and the investigators took advantage of the~     investigators own expertise regarding deep brain stimulation and subcaudate tractotomy.~      Protocol is strictly identical to the one of Mayberg and Lozano in order to confirm their~     preliminary results. Cartography of physiological consequences of this procedure will be~     assessed by measuring cerebral blood flow by PET scan (positron emission tomography).~     Patients will be monitored and thoroughly assessed during including psychiatric,~     neurological, neurosurgical, neuropsychological and PET scan exams to measure treatment~     efficacy and potential adverse reactions. Patients will be followed for two more years to~     assess medium-term complications. This study will be a first step toward further research~     including potentially a multicentric clinical trial.~   "
132381|NCT01834547|"~     Effects of caffeine, methylphenidate, modafinil and placebo on cognitive performance of chess~     players in chess games and neuropsychiatric standardized tests. We hypothesize that~     substances will change cognitive performance in chess players leading to changed results in~     chess games and neuropsychiatric tests.~   "
132382|NCT01834534|"~     The objective of this research is to test the efficacy of CarePartners for Depression~     (CP-D) intervention, which was designed to increase between visit monitoring of depression~     status and enhance self-management.~      **In order to participate, subjects must be patients at participating clinics: Alcona Health~     Center, Cherry Street Health Services, Dua Family Practice, Morang Chester.~   "
132383|NCT01834521|"~     The ever expanding breast cancer survivor population urges the health care system to develop~     (cost-)effective screening and management of convalescent care needs that can be easily~     implemented in conventional follow-up care. Internet-delivered systems may be well-equipped~     to meet these demands. The aim of the current study is to assess the effectiveness of a~     web-based support system. Key features of this system are patient self-screening of physical~     and psychosocial problems, tailored patient education on reported problems and self-referral~     to professional care. In this era of high internet usage, we expect that internet is a highly~     suitable medium to provide tailored support for breast cancer patients and will empower the~     patient to take control over their convalescence.~   "
132384|NCT01834508|"~     The purpose of this study is to evaluate the long-term efficacy and safety of entecavir 0.5~     mg/d + adefovir 10 mg/d for treatment experienced chronic hepatitis B patients.~   "
132385|NCT01834495|"~     The purpose of the investigators study is to examine and compare primary patency between~     balloon expandable cobalt chromium stent and self expandable nitinol stents (SCUBA versus~     COMPLETE-SE) in atherosclerotic iliac artery lesion.~   "
132386|NCT01834482|"~     The modified Atkins diet (MAD) has been shown to be effective in treating children and adults~     with medically resistant seizures. A recent study in children showed that the use of KetoCal®~     once per day in addition to the MAD appeared to be beneficial when used during the first~     month. The investigators hypothesize that including a daily KetoCal® liquid tetrapak with one~     meal during the initial month of the MAD will produce urinary ketosis in more adult patients~     than the MAD alone and will lead to greater seizure reduction.~   "
132387|NCT01834469|"~     The purpose of this study is to determine if NIF fluorescent imaging is an effective approach~     to detect the gross ovarian tumoral tissues and peritoneal implants in Ovarian cancer~     patients.~   "
132388|NCT01834456|"~     Under the auspice of 'Specially for Children and with funding from the Seton Healthcare~     Family, Children's Comprehensive Care (CCC) in Austin, Texas, has developed a coordinated and~     integrated model of care for children with medical complexity. This model serves as the~     patient's Medical Home (primary care provider, (PCP)), and uses extensivists (physicians who~     work as hospitalists and within the PCP) and nurse practitioners to provide continuous care~     between hospital and primary care. This model seeks to provide a system of care that more~     fully meets the complex needs of the child and family, while implementing innovations in care~     delivery, fully implementing family-centered practice, and embedding behavioral,~     psychiatric, psychosocial, and palliative care. This study is a randomized intervention trial~     that evaluates the effectiveness of the newly-created Children's Comprehensive Care on two~     outcomes: utilization and cost of care; and, evaluation of the experience of parents and~     their families.~   "
132389|NCT01834443|"~     The purpose of this study is to determine whether galvanic vestibular stimulation is~     effective in the treatment of spatial neglect after right brain-damage.~   "
132390|NCT01834430|"~     Different studies suggest that early enteral nutrition (EEN) has benefits in reducing~     infectious complications, there is no data that addresses whether delayed enteral nutrition~     (EN) is detrimental and if it may have effects on inflammatory responses and immune function.~   "
132391|NCT01834417|"~     Analysis of stored seat-pressures in SCI patients during a 4-week use of an on-board device.~     During this period, patients write in an agenda noteworthy events that could occur while~     they're using their wheelchair. A control is done every week and the device can be changed~     until it is returned at the end of the study period.~   "
132392|NCT01834404|"~     Our overall goal is to determine the effect of Phentermine and Topiramate ER on gastric~     emptying, gastric accommodation, satiety, and satiation in obese participants.~   "
132393|NCT01834391|"~     The purpose of this study is to see if the investigators can identify early those patients~     who are admitted to the hospital and have a urinary tract infection (UTI) or those patients~     that develop a UTI during their hospitalization.~   "
132394|NCT01834378|"~     We randomize individuals with impaired glucose tolerance to one of three arms for degree of~     physical activity: 1. Continue with your current life style; 2. Ordinary life activities for~     increased physical activity; 3. Scheduled group activities for changed behavior. The overall~     aim is to focus on change of physical activity and to keep other life style activities more~     or less unchanged (diet, smoking, etc) and the effect on metabolic variables.~   "
132395|NCT01834365|"~     There is a structured educational effect on blood pressure reduction in elderly hypertensive~     patients.~   "
132401|NCT01834287|"~     In this study, investigators are specifically targeting Latina women as they are more likely~     to be inactive and, therefore, are at higher risk for developing chronic conditions such as~     obesity, diabetes, or cardiovascular disease.~      The objective of Pasos Hacia La Salud is to test a Spanish-language Internet-based Physical~     Activity Intervention, in comparison to a Spanish-language Internet-based Wellness Contact~     Control condition. Participants are randomly assigned to one of two groups (Exercise and~     General Wellness).~      The investigators hypothesize that at the end of treatment, intervention participants will~     report significantly more minutes of moderate intensity physical activity per week than the~     wellness contact control participants.~   "
132402|NCT01834274|"~     The purpose of this study is to evaluate the efficacy of fasiglifam (TAK-875) plus metformin~     compared with sitagliptin plus metformin on glycemic control over a 24-week Treatment Period.~   "
132403|NCT01834261|"~     Oxytocin is a neuropeptide that is well known for its role in social and affiliative behavior~     in humans. Oxytocin receptors are significantly lowered in autistic individuals and~     administration of oxytocin has shown benefits in enhancing social recognition and behavior in~     autistic children. However, more recent research has refined the behavioral effects of~     oxytocin, moving away from the notion that the neuropeptide blindly induces love and trust,~     towards the view that it actually increases social perception in assessing friend vs. foe:~     supporting cohesion with 'insiders' and distrust and aggression for 'outsiders.' Oxytocin is~     responsible for the selective aggression shown by lactating female mammals protecting their~     young, an effect demonstrated also in humans, and has been shown to strengthen feelings of~     ethnocentrism. However, no neuroimaging study to date has investigated this effect, with the~     consequence that its neurobiological basis is still unknown.~      The general aim of our study is to determine meso-circuit brain dynamics that underlie~     oxytocin's amplification of both trust and aggression; and specifically, using neuroimaging~     (fMRI, magnetoencephalography, and behavioral testing) whether oxytocin amplifies kinship~     bias by attenuating social reward learning.~   "
132404|NCT01834248|"~     This phase I trial studies the side effects and immune response to DEC-205/NY-ESO-1 fusion~     protein CDX-1401 and decitabine in patients with myelodysplastic syndrome or acute myeloid~     leukemia. DEC-205-NY-ESO-1 fusion protein, called CDX-1401, is a full length NY-ESO-1 protein~     sequence fused to a monoclonal antibody against DEC-205, a surface marker present on many~     immune stimulatory cells. This drug is given with another substance called PolyICLC, which~     acts to provoke any immune stimulatory cells which encounter the NY-ESO-1-DEC-205 fusion~     protein to produce an immune response signal against NY-ESO-1. Immune cells which have thus~     been primed to react against NY-ESO-1 may then attack myelodysplastic or leukemic cells which~     express NY-ESO-1 after exposure to the drug decitabine. The chemotherapy drug decitabine is~     thought to act in several different ways, first, it may directly kill cancer cells, and~     secondly, the drug can cause cancer cells to re-express genes that are turned off by the~     cancer, including the gene for NY-ESO-1. Giving DEC-205/NY-ESO-1 fusion protein (CDX-1401)~     and polyICLC together with decitabine may allow the immune system to more effectively~     recognize cancer cells and kill them.~   "
132405|NCT01834235|"~     This is a randomized phase II multi-institution prospective open label study in which up to~     90 subjects with metastatic, locally advanced unresectable or recurrent pancreatic cancer who~     previously received treatment with chemotherapy with FOLFIRINOX or FOLFIRINOX-like regimen~     will be enrolled into one of two arms:~      A: NPC-1C with gemcitabine and nab-paclitaxel or B: gemcitabine and nab-paclitaxel~   "
132406|NCT01834222|"~     The purpose of this study is to assess safety profile of Prevenar 13™ when used among Korean~     adults in the routine clinical setting, as required for any new drug approved by Korea Food~     and Drug Administration (KFDA).~   "
132407|NCT01834209|"~     The purpose of this study is to collect additional safety data during treatment with~     abiraterone acetate plus prednisone or prednisolone among adult participants with~     asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer (mCRPC)~     who reside in areas in which abiraterone acetate is not yet available for this indication~     through local healthcare providers, and who are not eligible for enrollment into an available~     ongoing clinical study of abiraterone acetate.~   "
132408|NCT01834196|"~     This is a clinical pilot study to assess the feasibility of using a swept-source optical~     coherence tomography (SSOCT) system to perform noninvasive imaging of the retinal vasculature~     in patients with existing microvascular disease.~   "
132409|NCT01834183|"~     This research study is a PHase II clinical trial, which tests the safety and effectiveness of~     an investigational combination of drugs to learn whether the combination of drugs works in~     treating a specific cancer. Investigational means that the combination of drugs is being~     studied. It also means that the FDA has not yet approved these drugs or combination of drugs~     for use in participants, including people with your type of cancer.~      Tivozanib is an anti-angiogenesis medicine that fights cancer by cutting off a tumor's blood~     supply so that it does not get the blood and nutrients it needs to grow. This drug has been~     used in other research studies and information from those other research studies suggests~     that this drug may help to slow the growth of cancer cells.~      Gemcitabine is a chemotherapy drug that is approved by the FDA for the treatment of~     pancreatic cancer and several other cancers. It is not approved for the treatment of renal~     cell carcinoma. Previous research suggests combining gemcitabine with tivozanib may have some~     effectiveness in treating metastatic renal cell carcinoma.~      The purpose of this research study is to determine the effectiveness of tivozanib as a~     treatment for renal cell carcinoma. The purpose of this research study is to also determine~     if the combination of tivozanib and gemcitabine is effective in treating your type of cancer~     if your cancer becomes unresponsive or gets worse with tivozanib as treatment alone. The~     safety of the combination of tivozanib and gemcitabine will also wbe studied.~      Another goal of this research study is to learn more about how tivozanib alone and the~     combination of tivozanib and gemcitabine may work to treat renal cell carcinoma. During the~     research study we will perform blood tests to measure the level of substances in the blood~     such as proteins (biomarkers) that may predict who will respond to treatment with tivozanib~     and gemcitabine.~   "
132410|NCT01834170|"~     Pancreatic cancer is the 11th most common type of cancer but it is the fourth leading cause~     of cancer death. The only effective treatment for pancreatic cancer includes surgery.~     However, only 20% of the patients have surgically treatable disease. Also, the 5-year~     survival for the surgically treated patients is only 15%.~      About 40% of the patients present with advanced disease with distant metastasis, and the~     remaining 40% present with locally advanced unresectable cancer with the tumor invaded into~     surrounding major vessels. For those with locally advanced disease, systemic chemotherapy~     with or without radiotherapy provides palliation of the symptoms but cannot cure the~     disorder. Systemic chemotherapy is given through peripheral vessels.~      The investigators hypothesized that direct injection of the chemotherapeutic drug into the~     tumor may help to boost the effect of systemic chemotherapy and radiotherapy in those with~     locally advanced pancreatic cancer.~   "
135509|NCT01793571|"~     An prospective double blinded randomised trial,whether the use of an perioperative echoguided~     unilateral TAP block has an superior effect on postoperative pain after open hernia inguinal~     repair compared to wound infiltration with a long acting local anesthetic.~   "
132411|NCT01834157|"~     Systemic sclerosis (SSc) is an orphan, multiorgan disease affecting the connective tissue of~     the skin and several internal organs. Beside skin involvement, digital ulcers, tendinitis,~     calcinosis and flexion contractures, the presence of hand arthritis is a major contributor to~     impairment of hand function in systemic sclerosis. Several immunomodulatory drugs used in~     other rheumatic diseases (including methotrexate, leflunomide, azathioprine, mycophenolate~     mofetil and low-dose corticosteroids) can potentially improve arthritis and consequently hand~     function in systemic sclerosis. For the assessment of arthritis, the CDAI (clinical disease~     activity index) is validated in rheumatoid arthritis, and may be useful for SSc-related~     arthritis, too.~      This observational trial is part of the collaborative project DeSScipher, one out of five~     observational trials to decipher the optimal management of systemic sclerosis. Aim of this~     observational trial is to:~        -  investigate the efficacy and safety of different treatments on hand dysfunction in~          systemic sclerosis patients with hand arthritis and~        -  to validate the CDAI for arthritis in systemic sclerosis.~   "
132412|NCT01834144|"~     Background/Justification: Regular physical activity (PA) has substantial health benefits in~     persons with type 1 diabetes (T1D), including reduced risk of complications and~     cardiovascular mortality. Despite these benefits, individuals with T1D remain significantly~     less active than their peers without diabetes. Two major factors likely explain the low rates~     of PA in young people with T1D: (1) fear of post-exercise hypoglycaemia, particularly~     nocturnal hypoglycaemia, and (2) a lack of empirical evidence for the efficacy of PA for~     achieving optimal glycaemic control. A number of acute exercise trials recently demonstrated~     that the inclusion of vigorous intensity PA in conventional moderate intensity (i.e. walking)~     PA sessions may overcome these limitations. No studies have tested the efficacy of high~     intensity PA for reducing the risk of exercise-related hypoglycaemia or glycaemic variability~     in a randomized controlled trial (RCT).~      Study Hypotheses: In persons 15-35 years of age living with T1D, this study will test the~     hypotheses that (1) the addition of intermittent vigorous intensity PA to a moderate~     intensity intervention will reduce the time spent in hypoglycaemia in the 12 hour period~     following exercise and (2) the addition of intermittent vigorous intensity PA to a moderate~     intensity PA intervention will elicit significant improvements in glycemic excursions, as~     measured by the Mean Amplitude of Glycaemic Excursions (MAGE), in the 12-hour period~     following exercise.We are also exploring the hypothesis that reducing the risk of~     hypoglycemia will lead to a sustained increase in physical activity one year after~     randomization.~   "
132413|NCT01834131|"~     The objective of this cluster randomized trial is to test whether a comprehensive~     intervention program within a national public primary care system will improve hypertension~     control among uninsured hypertensive patients and their families in Argentina.~   "
132414|NCT01834118|"~     The purpose of this study is to determine the effect of repeated renal denervation in~     non-responding patients with severe hypertension. Therefore ultrasound technique will be~     used.~   "
132415|NCT01834105|"~     This study use RT-PCR and Western Blot technique to detect the expression of CLCF1 mRNA and~     protein in POP Kidney Yin deficiency group and healthy group to verify the relevance between~     CLCF1 and POP the kidney Yin deficiency syndrome.Through siRNA and overexpression,observe the~     mRNA and protein 's expression of CBP、JAK1、STAT4 and the protein phosphorylation of~     JAK1、STAT4 in JAK-STAT signal to reveal the CLCF1 regulate the CBP's mechanism.Use the Liuwei~     Dihuang Pills to detect the effect of treatment ,compare use or not the Liuwei Dihuang Pills~     to detect the mRNA and protein 's expression of CLCF1、CBP etc.Aim to clarify the POP kidney~     Yin deficiency molecular mechanism.~   "
132416|NCT01834092|"~     The investigators want to measure the degradation of the endothelial glycocalyx before and~     after clamping the aorta, in patients operated for a abdominal aortic aneurism.~   "
132417|NCT01834079|"~     This is a Single arm, Single centre trial to check the safety and efficacy of bone marrow~     derived autologous mono nuclear cell(100 millions per dose )clinical trial to be conducted~     for 36 months in patients with optic nerve diseases.~   "
132418|NCT01834066|"~     This Study is single arm, single centre trial to check the safety and efficacy of Bone Marrow~     derived autologous cell(100 million per dose) for the patient with Duchenne Muscular~     Dystrophy.~   "
132419|NCT01834053|"~     This study is Single arm, Single Centre trial to check the Safety and Efficacy of Bone Marrow~     Derived Autologous mononuclear cell {MNC} (100 Million per dose).trial to be conducted for 36~     months in patients with diabetes Mellitus in India,Primary outcome measure are Improvement in~     cognitive and Psychiatric Symptoms and Improvement in Jerky,random, and Uncontrollable~     Movements called Chorea.~   "
132420|NCT01834040|"~     This Study is single arm, single center trial to check the safety and efficacy of BMMNC (100~     million per dose) for the patient with Duchenne Muscular Dystrophy,~   "
132421|NCT01834027|"~     The purpose of this study is to investigate the effects of music on patients after surgery in~     the Post Anesthesia Care Unit (PACU). For many patients, surgery creates significant~     emotional stress and anxiety which can include discomfort or pain. Music therapy has proven~     to be a useful adjuvant in various inpatient and outpatient settings by providing a relaxing~     effect that decreases heart rate, blood pressure, and hormonal measures of stress. It has~     been shown that classical music can cause physiological and psychological differences in~     patient outcomes, but few studies have looked specifically at effects of jazz music. Some~     have argued that jazz may be too involved to provide the same relaxed state as classical~     music, but this may be due in part to the type of jazz played for the patient. It is our~     hypothesis that slow jazz music by artists including Miles Davis, Ella Fitzgerald, Diana~     Krall, Dave Brubeck, etc. will reduce measures of stress and anxiety in patients in the PACU~     following surgery for hysterectomy (laparoscopic or robotic) to a greater extent than the~     control group. Jazz music or no music will be played through headphones to participants in~     the study post-surgically while they are in the PACU and measures of stress, anxiety, and~     pain will be monitored.~   "
132422|NCT01834014|"~     The correlation between the values of angiogenesis-related growth factors in plasma and~     efficacy, and biomarkers relevant as prognostic factors or predictive factors for sensitivity~     or resistance to treatment will be examined exploratively.~   "
135842|NCT01789177|"~     We hypothesize that the addition of modified incentive spirometry to standard postoperative~     chest physiotherapy will be associated with faster return to baseline/predicted pulmonary~     function and fewer postoperative pulmonary complications in patients following laparotomy.~   "
132423|NCT01834001|"~     Background:~      - Radiation is a common treatment for prostate cancer. It helps damage tumor cells and causes~     them to die. Radiation can be effective, but some tumors may be harder to treat with~     radiation or even with surgery. This happens to a small number of men who have either~     radiation or surgery for prostate cancer. Most men who have these hard-to-treat tumors do not~     know if the tumor has recurred only in the prostate or has spread to another area. Also, men~     whose prostate cancer has recurred only after radiation may have different treatment options.~     This study will use improved imaging studies to better understand why some men do not respond~     as well to initial radiation treatments.~      Objectives:~      - To use detailed imaging studies to look at the results of local radiation therapy for~     prostate cancer.~      Eligibility:~        -  Men at least 18 years of age who are scheduled to have radiation for prostate cancer.~        -  Men at least 18 years of age whose prostate cancer has returned after earlier~          treatments.~      Design:~        -  All participants will have a medical history and physical exam. Blood and urine samples~          will be collected. Imaging studies will be used to evaluate the cancer at the start of~          the study.~        -  All participants will have an initial full magnetic resonance imaging (MRI) scan of the~          prostate. Tumor and healthy tissue samples will be collected.~        -  Those whose cancer has recurred after treatment will discuss possible treatment options~          with the study doctors.~        -  Participants who are scheduled to have radiation will have radiation therapy. This will~          be given according to the current standard of treatment.~        -  After radiation, participants will have regular follow-up tests and imaging studies.~          They will have another full MRI scan 6 months after the end of radiation treatment.~   "
132424|NCT01833988|"~     This study will test the hypothesis that a wearable automated bionic pancreas system that~     automatically delivers both insulin and glucagon can improved glycemic control vs. usual care~     for young people with type 1 diabetes 12-20 in a diabetes camp environment.~   "
132425|NCT01833975|"~     This Study is a single arm,Phase I/II , single centre trial to check active comparing the~     safety and efficacy of Bone marrow derived autologous cell(100 million per dose) trial to be~     conducted for 36 months.~   "
132426|NCT01833962|"~     The purpose of this study is to assess fusion status in patients who underwent spinal fusion~     with Actifuse synthetic bone graft versus other bone graft material (including autograft) in~     achieving lumbar spinal fusion.~   "
132427|NCT01833949|"~     The objective of our study was to compare the efficiency of the right ULOD using thermal~     doses adjusted to ovarian volume (60 J/cm3) with the BLOD method at constant dose and to~     assess treatment efficiency.~   "
132428|NCT01833936|"~     Calf muscle atrophy (muscle degeneration) is common following Achilles tendon repair due to~     the immobilization period necessary to ensure optimal healing.~      The purpose of this study is to determine if the use of neuromuscular electrical stimulation~     (NMES) after Achilles tendon surgery will reduce calf muscle atrophy.~   "
132429|NCT01833923|"~     Anlotibib (ALTN) is a kind of innovative medicines approved by State Food and Drug~     Administration（SFDA） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co.,~     Ltd.~      ALTN is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2 and~     VEGFR3. It has the obvious resistance to new angiogenesis.~   "
132430|NCT01833910|"~     Prompt delivery of cardiopulmonary resuscitation (CPR) can double a victims chance of~     survival from cardiac arrest (CA), yet it is provided in less than 1/3 of witnessed events.~     Studies indicate that video-based education methods can effectively train bystanders in CPR.~     Using the education and evaluation methods of an existing in-hospital training program, the~     investigators will assess the CPR skills of students taught with video-only methods, with and~     without psychomotor skills practice, and compare them to those using a video self-instruction~     (VSI) kit.~   "
132431|NCT01833897|"~     The purpose of this study is to test whether ketamine and D-cycloserine can be safely and~     effectively used for the treatment of depression. The investigators hypothesize that ketamine~     will serve as a rapid acting and safe antidepressant in patients with bipolar depression, and~     furthermore, that D-cycloserine will serve as an effective therapy following ketamine~     treatment.~   "
132432|NCT01833884|"~     More than 90% of patients with Hodgkin lymphoma (HL) can recover thanks to conventional~     polychemotherapy regimens - ABVD or BEACOPP - with or without radiotherapy. Nevertheless,~     some patients relapse and others are resistant to any treatment. These patients represent~     2-5% of stage I / II and 5-10% of disseminated stages. The usual prognostic index based on~     clinical and biological data (supradiaphragmatic HL: EORTC and advanced HL International~     Prognostic Score) cannot always detect patients at risk.~      New prognostic factors are required to screen out these high risk patients. Among available~     biological factors, we will retain the cytokines secreted by tumor cells and cells from the~     environment.~      Indeed, the prognostic value of plasma cytokines levels and their soluble receptors has~     recently been described by at least two teams. Olivier CASASNOVAS set up a prognostic index~     based on quantities of IL-1 RA, IL-6, sCD30 and TNFR1 at diagnosis,and the V. Diehl team~     published the prognostic value of the decrease of TARC (CC Thymus and Activation-related~     chemokine).~      In daily practice, the early assessment of response by PET CT-scan is now an undeniable~     prognostic factor. Early identification of no-response or relapse is, in fact, based on~     clinical and imaging (PET-CT scan).~      We propose to evaluate the decrease of cytokines concentration with a prognostic value (TARC,~     IL-6, IL1-RA, sCD30, TNFR1) as markers of response during treatment and during early~     follow-up. The dosage of these cytokines will be paired with radiological assessments.~      A correlation between the decrease of cytokines plasma levels overtime and event-free~     survival will be searched afterwards.~   "
132433|NCT01833871|"~     Colour Doppler sonography has also been evaluated in differentiating adenomyosis from~     fibroids. Two dimensional color Doppler ultrasound revealed that 87% of adenomyosis cases had~     vessel distributions different from those found in leiomyoma cases, in addition to a high~     pulsatility index (PI) .Adenomyotic lesions had randomly scattered vessels or intratumoral~     signals while leiomyomas usually had peripheral scattered or outer feeding vessels.~   "
132445|NCT01833715|"~     The aim of this study is to compare the efficacy of methadone versus morphine in dealing with~     postoperative pain, in laparoscopic cholecystectomy under total intravenous anesthesia~     (TIVA); Efficacy is defined in terms of the difference of milligrams in morphine used as~     rescue analgesia postoperatively. Our hypothesis is that methadone is more effective than~     morphine for postoperative pain treatment.~   "
132446|NCT01833702|"~     The study will seek to enroll 100 sickle cell or thalassemia patients who are age 12 or older~     who have access to a smartphone or tablet with Internet access daily.~      The study will evaluate patient-reported comfort level with using a mobile device to record~     their pain levels, as well as adherence to recording these levels daily.~      The study will track patients' assessment of their pain, actions taken, and outcomes related~     to pain management and provider involvement.~      This study will attempt to collect information about differences in the use of two~     traditional pain assessment modes (verbal scale and paper) versus the use of a pain~     assessment tool on a mobile device in the form of a smartphone, tablet, or iPad with an~     Android or iOS operating system.~   "
132434|NCT01833858|"~     A novel gonadotropin protocol for ovarian stimulation adds low-dose hCG (50- 200 IU) as a~     source of LH (luteinizing hormone) in the late follicular phase .~      This regimen reduces the number of small pre-ovulatory follicles which could reduce the risk~     of OHSS(ovarian hyper stimulation syndrome). Adequate ovarian hormonal levels , oocyte~     maturation, avoidance of a premature LH surge, and increased pregnancy rate are the other~     benefits of this regimen.~      HCG might also affect endometrial function, stimulate endometrial growth and maturation and~     enhance the endometrial angiogenesis. These effects could extend the angiogenesis. These~     results could lengthen the implantation Window.~      Inhibin A is a heterodimer protein and does not begin to increase until just after the~     increase in oestradiol in the late follicular phase, suggesting secretion by the dominant~     follicle. Inhibin A secretion is regulated by LH and is associated with paracrine/autocrine~     action on oocyte maturation. Moreover, it is related to follicular development and size,~     serving as a marker of follicular maturation after IVF cycles .However, the role of hCG~     supplementation during COH (controlled ovarian hyperstimulation)is still a matter of debate~     and more studies is needed. Thus, the objective of this trial was to investigate whether LH~     activity in the form of low dose hCG in GnRH (Gonadotropin releasing hormone)antagonist~     cycles would improve the quality of oocytes, level of inhibin A and endometrial vascularity.~   "
132435|NCT01833845|"~     Proof-of Concept, Open-Label, Two-Stage Study without Direct Individual Benefit The proposed~     study design consists of two treatment periods and one treatment arm. Treatment Period 1~     involves the administration of RBV monotherapy for a period of 8 weeks and Treatment Period 2~     involves administration of up to 16 weeks combination therapy with RBV plus HCQ.~   "
132436|NCT01833832|"~     Background:~      - Adrenocortical carcinoma (ACC) is a rare tumor of the adrenal gland. Few people who develop~     this disease live more than 5 years after being diagnosed. Those whose tumors have spread~     inside their abdomen may have an especially poor outcome. In these cases, traditional~     chemotherapy is not very effective. One possible new treatment is aggressive surgery with~     heated chemotherapy. This type of treatment has been more effective for other types of cancer~     in the abdomen. Researchers want to see this if approach can improve the outcomes of people~     with ACC.~      Objectives:~      - To test the safety and effectiveness of surgery and heated chemotherapy for ACC.~      Eligibility:~      - Individuals at least 18 years of age who have advanced ACC.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood samples~          will be collected. Heart function tests will be given. Imaging studies will be used to~          locate the surgical sites before the operation.~        -  Participants will have surgery to remove ACC tumor tissue. After the tumors have been~          removed, they will have heated chemotherapy with cisplatin. The heat may help weaken any~          remaining cancer cells and make them easier to destroy. It will also focus the treatment~          on the tumor sites, rather than the whole body.~        -  Participants will recover in the hospital for several days after surgery. They will have~          regular follow-up visits to monitor the outcome of the surgery.~   "
132437|NCT01833819|"~     Opioids may attenuate postoperative hyperalgesia and postoperative nausea and vomiting. Our~     hypothesis is: opioid-free total intravenous anesthesia with propofol, dexmedetomidine and~     lidocaine infusions for laparoscopic cholecystectomy may achieve comparable hemodynamic~     stability during laparoscopy, with lower postoperative analgesic consumption and incidence of~     postoperative nausea and vomiting.~   "
132438|NCT01833806|"~     The study hypotheses is that the proportion of patients experiencing clinically significant~     pain relief will be at least 30% greater than the proportion experiencing worsening pain.~   "
132439|NCT01833793|"~     MARILIA is a prospective, non-interventional, multicenter study. The purpose of this study is~     to describe the acceptability of Amenorrhea in contraception indication of Mirena users~     during one year follow up in medical practice. 500 patients in 20 centers will be enrolled in~     the study. Bleeding profile, removal or non-removal of the IUS (IntraUterine System) will be~     evaluated.~   "
132440|NCT01833780|"~     Study hypothesis: Intrapartum polimeraze chain reaction (PCR)of group B streptoccocus (GBS)~     test is more accurate than Culture of GBS at 35-37 weeks gestation for GBS carriage.~      The investigators will compare GBS culture and PCR results taken at 35-37 weeks gestation to~     intrapartum PCR GBS and GBS cultures status.~      The larger perspective of this trial is to check the possibility of replacing the GBS culture~     screening program at 35-37 weeks gestation with a more accurate examination (PCR), avoiding~     the changing GBS carriage status from the time of culture at 35-37 weeks to delivery.~   "
132441|NCT01833767|"~     The purpose of this study is to determine response rates by administering low dose~     cyclophosphamide on day 1, followed by 5 days of outpatient IL2.~   "
132442|NCT01833754|"~     The purpose of this study is to evaluate the safety, tolerability, and immunogenicity profile~     of romosozumab after a single 210 mg subcutaneous dose in healthy participants and patients~     with stage 4 renal impairment (RI) or stage 5 RI requiring hemodialysis.~   "
132443|NCT01833741|"~     This study will evaluate bimatoprost 0.01% (LUMIGAN® RC) in patients with elevated~     intraocular pressure (IOP) due to primary open angle glaucoma (POAG) or ocular hypertension~     (OHT) in a clinical setting.~   "
132444|NCT01833728|"~     The multimodal analgesia for postoperative pain aims for optimal analgesia through additive~     or synergic drug effects. The multimodal analgesia results in the use of smaller doses of~     opioids and lowering opioid-related side effects.~      Non-opioid analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), propacetamol (prodrug~     of acetaminophen), nefopam are often given along with opioids as part of multimodal analgesia~     after major surgery.~      NSAIDS, commonly used non-opioid analgesics, have gastro-intestinal, renal, and cardiac side~     effects.~      In contrast, propacetamol or nefopam, two drugs with central analgesic effects, can be safely~     used as analgesic adjuvants with opioid after nephrectomy, because these drugs do not alter~     renal function or cause hemorrhagic complications.~      Recent study demonstrated that the antinociceptive properties of paracetamol (intravenous~     acetaminophen) associated with the analgesic effectiveness of nefopam could explain the~     observed synergy of the combination.~      The aim of this randomized, double-blinded study is to compare the opioid-sparing effect and~     analgesic efficacy, as well as quality of recovery, of nefopam-propacetamol combination and~     propacetamol in patients undergoing laparoscopic nephrectomy.~   "
132447|NCT01833689|"~     The objective of this study is to assess the effect that dietary carbohydrates have on blood~     sugar by measuring the glycaemic index. The glycaemic index is a comparison between the~     effect of equal amounts of carbohydrate from a test food compared to a standard (in this case~     glucose) on blood sugar.~      Different foods that contain different carbohydrates have different effects on blood sugars.~     This is of interest as a number of studies have shown that the level of sugar in the blood~     after a meal relates directly to the risk of developing heart disease and diabetes. The aim~     of collecting this data is to be able to give advice to people about the carbohydrates they~     eat to reduce the risk of diabetes and heart disease.~   "
132448|NCT01833676|"~     Anaesthesia and surgery has become more common in the elderly as the population survives~     longer. Anaesthesia in the elderly confers a higher risk which is related to the aging~     process and the diseases that accompany seniority. As such, there is a need to provide~     optimal anaesthetic management in order to minimize complications and risks perioperatively.~     One of the changes associated with ageing is the progressive decrease in protective laryngeal~     reflexes. Any depression of upper airway reflexes increases the chance of pulmonary~     aspiration and compromises the maintenance of the airway.~      Desflurane is an inhalational agent strongly favored due to its lower solubility in blood,~     lean tissue and fat as compared to sevoflurane. This enables the agent to be quickly~     eliminated at the end of surgery, with minimal metabolic breakdown, thus facilitating more~     rapid emergence as compared to sevoflurane anesthesia in elderly undergoing general~     anaesthesia. McKay et al conducted a study in 2005 in US, which showed that the choice of~     inhalational agent itself can influence the return of protective airway reflexes. In the~     study, the inhalational agent sevoflurane was found to cause significant impairment of~     swallowing, in comparison with desflurane(1). However, the aforementioned study focussed on~     the general population. As such, the purpose of this study is to determine whether the choice~     of inhalational anesthetic (sevoflurane versus desflurane) has similar influence on the~     return of protective airway reflexes in the geriatric population in Malaysia, and whether the~     significance is greater in the elderly population.~   "
132449|NCT01833663|"~     This study is a multi-site, randomized, opened and parallel-controlled clinical study.~      The patients up to the inclusion criteria are randomly treated with Solifenacin Succinate~     Tablets (5mg/d) or Solifenacin Succinate Tablets (5mg/d) + local estrogen for 12 weeks.~     Before the dosing and at Week 4, 8 and 12 of the dosing, various examinations are made, and~     various indices are evaluated.~   "
132450|NCT01833650|"~     The purpose of this study is to determine whether the use of honey mouthwashes in the~     prevention of salivary side effects of 131I (radioiodine) therapy.~   "
132451|NCT01833637|"~     The purpose of this study is to assess whether using computerized screening questions can~     improve how well we manage symptoms related to cancer and cancer treatments. Advance care~     planning is a process in which teams of experts assist in with treatment plans, managing pain~     and other symptoms, emotional issues, and end of life issues. With advances in technology, it~     is now possible to get the patient's feedback directly and more often. It is thought that~     repeated questionnaires completed by the patient will provide a better and more accurate~     measure of the patient's needs and experiences but this has not been tested. This study is~     designed to learn if using a computerized assessment repeatedly is better than standard~     planning techniques.~   "
132452|NCT01833624|"~     An early and efficient enteral nutritional support could improve the clinical outcomes of~     brain injured critically ill patients. Gastrointestinal feeding intolerance defined as an~     increased gastric residual volume frequently occurs in these patients.~      Previous experimental studies have suggested that a small-peptide enteral feeding formula~     could promote the gastric emptying compared to a whole-protein formula. An improved~     gastrointestinal tolerance of enteral nutrition should allow a rapid increase in the daily~     caloric intake and enhance nutritional support of brain injured critically ill patients.~   "
132453|NCT01833611|"~     Entecavir (ETV) has shown superior ability to suppress hepatitis B virus (HBV) replication,~     histology improvement as well as low rate of emergence of resistant mutants. Out of range of~     clinical recommendations for treatment of chronic hepatitis B (CHB), chronic HBV carriers~     with persistently normal ALT and viral load more than 10^5 copies/mL have progression of~     liver disease during long-term follow-up. In addition, certain proportions of these patients~     do have significant inflammation and fibrosis in liver histology. This study will be able to~     identify who are at risk of liver disease progression and evaluate efficacy of ETV regarding~     improvement of liver histology during short-term (1-year) and long-term ETV treatment~     (3-year).~   "
132454|NCT01833598|"~     Tendinopathy is a clinical syndrome of chronic pain and tendon degeneration that impairs a~     person's ability to perform daily activities and recreation. Traditional conservative~     treatments include activity modification, exercises, ice/heat, and medications and~     corticosteroid injection. A newer treatment is percutaneous needle tenotomy (PNT), in which~     the affected area is repetitively needled to disrupt pathological tissue and induce bleeding.~     This turns a nonhealing chronic injury into an acute injury with enhanced healing capability.~     Another is Platelet Rich Plasma (PRP), whereby patients' own platelets are injected into the~     affected area, also activating growth factors. There has been promising research in these~     tendinopathy treatments but more research is needed.~      The investigators plan to expand on prior studies to identify a reproducible and efficacious~     treatment for chronic tendinopathy to reduce pain and improve function and quality of life.~     Our goal in this study is to assess the efficacy of ultrasound guided (USG) PNT versus PNT~     with peritendinous PRP as a treatment for chronic tendinopathy.~   "
132455|NCT01833585|"~     The purpose of this study is to determine the safety and efficacy of G-CSF-mobilized~     autologous peripheral blood mononuclear cell injection to ischemic limbs of patients with~     critical limb ischemia.~   "
132456|NCT01833572|"~     This is an open-label, single-arm, phase II interventional clinical trial. The investigators~     hypothesize that the application of EGFR-TKI, like gefitinib will be efficient and safe in a~     neo-adjuvant setting. 42 resectable stage II-IIIa NSCLC patients with EGFR activating (19/21)~     mutations will be eligible to be enrolled. EGFR mutation will be prospectively tested in all~     the participants' biopsy samples and confirmed in surgical resected samples. Eligible~     patients will be given gefitinib 250mg for 42days followed with surgical resection of tumor.~     Efficacy of preoperative gefitinib is based on radiographic (CT response/ORR), pathologic~     (pathologic response), surgical (complete resection) evaluations, and safety is based on~     adverse effect evaluations.~   "
132461|NCT01833507|"~     Obesity is common in adults with complex medical problems with ensuing complications~     afterwards. Obese patients suffer higher mortality and impaired functional status often as a~     result of their obesity. One primary goal to reduce both obesity and improve functional~     status is exercise. The investigators hypothesize that a simple exercise intervention with~     limited behavioral goal-setting will reduce weight and increase functional status compared to~     usual care. As a secondary measure, the investigators hypothesize that using this~     intervention will reduce hospital admissions and ER visits.~   "
132462|NCT01833494|"~     The purpose of this study is to investigate the safety and efficacy for 52-week dosing in~     hemodialysis patients with hyperphosphatemia.~   "
132463|NCT01833481|"~     In a previous study conducted within the Center for Musculoskeletal Research (CMR) on Total~     Hip Arthroplasties (THA), it was determined that the investigators could simultaneously~     capture in vivo sound and motion of the femoral head within the acetabular cup during~     weight-bearing activities for subjects implanted with either a metal-on-polyethylene (MOP),~     metal-on-metal (MOM) or ceramic-on-ceramic (COC) THA. This was the first study to apply sound~     analysis as an impulse excitation technique for testing hip conditions and for measuring~     femoral head sliding in the acetabular component of human hip joints by acoustic means.~     Unfortunately, no studies have been conducted to compare the in vivo kinematics and sound for~     subjects implanted using various surgical approaches. It could be hypothesized that subjects~     having various surgical approaches could lead to an increase or reduction of in vivo hip~     separation. Therefore, the objective of this study is to analyze a total of 30 subjects~     implanted with either an anterior (10 patients), anterior-lateral (10 patients), or~     posterior-lateral (10 patients) surgical approach to determine if any of these surgical~     approaches leads to less or more in vivo hip separation. All subjects will be analyzed under~     in vivo weight-bearing conditions using video fluoroscopy to determine in vivo motion.~   "
132464|NCT01833468|"~     Seronegative spondyloarthritis (SpA) is a group of rheumatic diseases Foot involvement of the~     SpA is common and enthesitis, erosive changes or ankylosis are the frequent lesions. The~     functional status of the SpA patients are usually evaluated globally.The aim of this study is~     to assess specifically the foot -related functional limitations of the SpA patients.~   "
132465|NCT01833455|"~     The purpose of this study is to determine if reduction in premature ventricular contraction~     (PVC) burden results in a decrease in blood pressure, sympathetic outflow, plasma~     catecholamines and an improvement in baroreflex gain. Flecainide will be used for PVC~     suppression in a randomized, double-blinded, crossover fashion.~   "
132466|NCT01833442|"~     The trial objective is to compare two very different meditation protocols (Kundalini Yoga and~     Relaxation Response meditation techniques) to help the OCD treatment.~   "
132467|NCT01833429|"~     The contribution of this study is the unedited evaluation of the circadian autonomic profiles~     of resistant hypertension with and without white-coat response.~   "
132468|NCT01833416|"~     Although the accumulated knowledge regarding Cytomegalovirus (CMV) infection increased~     substantially over the past years, several issues still deserve further investigation. The~     epidemiology of this disease has been changing, perhaps influenced by new immunosuppressive~     strategies currently used and growing and widespread use of prophylaxis. The knowledge of the~     CMV viral load kinetics, using a polymerase chain reaction (PCR-based assay), among renal~     transplant recipients not receiving any prophylactic therapy will allow the determination of~     risk factors for and the impact of earlier intervention on CMV infection and disease. The~     goal is to ultimately improve the clinical outcomes for renal transplant recipients.~   "
132469|NCT01833403|"~     This is a pilot study to show that it is possible to identify the specific types of fats in~     blood, adipose tissue, and liver tissue. The study doctors hope to use the analysis of these~     fats to learn more about nonalcoholic fatty liver disease (NFLD). Nonalcoholic fatty liver~     disease is the accumulation of fat in the liver of people who have minimal alcohol exposure.~     Nonalcoholic Fatty Liver Disease is associated with obesity and insulin resistance, and~     predicts development of Type 2 Diabetes. The study doctors are interested in looking at the~     relationship between liver fat and insulin resistance.~   "
132470|NCT01833390|"~     The purpose of this clinical trial is to demonstrate hyperpolarized xenon (HXe) as a medical~     imaging drug (agent) for Magnetic Resonance Imaging (MRI) of the human lung ventilation.~   "
132471|NCT01833377|"~     This study aims to investigate the applicability of caraway (black cumin) intake on the~     treatment of obesity. So, a randomized placebo controlled clinical trial will be conducted to~     examine the applicability of caraway product in terms of safety and efficacy.~   "
132472|NCT01833364|"~     By doing this study, the investigators hope to learn provide safety data that can be used to~     generate a larger phase III clinical trial. If successful, it would promote the development~     of a new treatment for PD in which patients are able to provide their own tissue as a source~     of a supportive environment for the injured and dying cells and thereby possibly stopping the~     progression of the illness or even improve the symptoms of PD.~      The purpose of this research is to gather information on the safety and feasibility of nerve~     graft implantation is. The results of this study will be shared with the University of~     Kentucky, Center for Clinical and Translational Science (group providing financial support~     for the study) and other federal agencies, if required.~      The overall goal of this research is to develop a novel, regenerative treatment strategy for~     idiopathic Parkinson's disease (PD) that is safe, cost effective and widely available to~     patients.~   "
132473|NCT01833351|"~     This Phase I study will be conducted in 2 parts to examine safety and pharmacokinetics of~     escalating doses of intravenous ascorbic acid (AA) first in healthy volunteers followed by~     evaluation in oncology subjects. The study will be conducted in the Program in Integrative~     Medicine Infusion Clinic at the University of Kansas Medical Center in conjunction with the~     Program in Integrative Medicine, Kansas Cancer Research Institute, Department of Pharmacy,~     Department of Medical Oncology, the Division of Surgical Oncology,and with consultants from~     the NIH, and FDA.~   "
132474|NCT01833338|"~     The accuracy of coronary plaque characterization with Multi-slice computed tomography as~     compared to intravascular ultrasound and optical coherence tomography will be investigated in~     patients presenting with acute coronary syndrome without ST-elevation.~   "
132475|NCT01833325|"~     This is a pilot study to determine if proton radiation therapy can provide effective and safe~     treatment for subfoveal neovascularization membrane (SNVM). The study will include adult~     patients over the age of 50 with macular degeneration, who have subfoveal neovascularization~     membrane (SNVM) and have had prior treatment with Avastin or Lucentis. Additional purposes of~     this study are to see if the growth of neovascular membranes can be stopped and overall~     vision improved with the use of protons and assess the side effects associated with this~     treatment.~   "
132476|NCT01833312|"~     The purpose of this study is to determine if systemic cooling to a target temperature of 34~     to 35°C, started within 6 hours of symptom onset and maintained for 12 hours, improves~     functional outcome at 3 months in patients with acute ischaemic stroke.~   "
132477|NCT01833299|"~     Hepatocellular carcinoma (HCC) is the 6th most common cancer and the third most frequent~     cause of cancer death worldwide. Hepatic resection (HR) has been the standard treatment~     modality for HCC aiming at clinical cure. In both Europe and Unit States proposed guidelines~     for HCC, HR was recommend only for patients with a single HCC lesion and preserved liver~     function . Unfortunately, only 10%-30% of HCCs are amenable to such curative surgical~     resection at the time of diagnosis, because of tumor multifocality, portal vein invasion, and~     underlying advanced liver cirrhosis . Alternatively, transarterial chemoembolization (TACE)~     has become the most popular modality for palliative treatment for the other patients.~     However, the long term outcomes were generally poor for HCC patients treated with TACE.~      Recently, sorafenib has shown some promises in improvement of 3-month survival among patients~     with advanced HCC. It is claimed that sorafenib has become the standard of care for patients~     advanced HCC.~      Thus, the purpose of this study was to prospectively compare the effectiveness of sorafenib~     combined with TACE with that of TACE alone in the treatment of unresectable HCC .~   "
132478|NCT01833286|"~     Hepatocellular carcinoma (HCC) is the fifth most common cancer in the world. Partial~     hepatectomy is still considered as the conventional therapy for HCC. Intrahepatic recurrence~     of HCC after partial hepatectomy is common and was reported to be more than 77% within 5~     years after surgery. Repeat hepatectomy is an effective treatment for intrahepatic HCC~     recurrence, with a 5-year survival rate of 19.4-56%. This is comparable to the survival after~     initial hepatectomy for HCC. Unfortunately, repeat hepatectomy could be carried out only in a~     small proportion of patients with HCC recurrence (10.4-31%), either because of the poor~     functional liver reserve or because of widespread intrahepatic recurrence. In the past two~     decades, percutaneous radiofrequency ablation (PRFA) has emerged as a new treatment modality~     and has attracted great interest because of its effectiveness and safety for small HCC (≤ 5.0~     cm). Studies using PRFA to treat recurrent HCC after partial hepatectomy reported a 3-year~     survival rate of 62-68%, which is comparable to those achieved by surgery. PRFA is~     particularly suitable to treat recurrent HCC after partial hepatectomy because these tumors~     are usually detected when they are small and PRFA causes the least deterioration of liver~     function in the patients. Our previous retrospective study demonstrated that RFA was~     comparable to re-resection for recurrent HCC, and our recent RCT showed that RFA combined~     with TACE is superior to RFA for HCC ≤7.0cm. So our hypothesis is that RFA combined with TACE~     is superior to re-resection for recurrent small HCC. The aim of this retrospective study is~     to compare the outcome of reresection with TACE+RFA for small recurrent HCC after partial~     hepatectomy.~   "
132479|NCT01833273|"~     In order to test the investigators hypothesis that 8 teaspoons of POLYMVA is safe in a~     population of patients with grade IV brain astrocytoma (glioblastoma multiforme), the~     investigators will conduct an open-label, prospective, un-blinded study. The investigators~     expect that at least 70% of subjects will tolerate the supplement and complete the trial. The~     investigators expect no Serious Adverse Event to occur during this trial which is~     attributable to study compound. During this study, the investigators will also collect other~     qualitative data to be utilized for future double-blinded studies which will be aimed at~     determining whether grade IV astrocytoma patients who receive PolyMVA achieve a better~     quality of life during their chemo-therapeutic regimens versus grade IV astrocytoma patients~     who do not receive PolyMVA.~   "
132480|NCT01833260|"~     The aim of this study was to evaluate the effect of listening to ambient music on the~     perceived exertion rate during pulmonary rehabilitation for chronic obstructive pulmonary~     disease patients.~   "
132481|NCT01833247|"~     This project looks at the time course of lactic acid rise (if any) after seizures. Salivary~     and capillary lactic acid are tested. This type of measurement may be useful in signalling~     the occurrence or recent history of a seizure.~   "
132482|NCT01833234|"~     The investigators are developing a questionnaire that can quickly measure the impact that~     epilepsy has on a person's life. This questionnaire will be useful in following whether the~     impact of epilepsy increases, decreases or stays the same over time. The results also may~     point out areas that would benefit from discussion or attention in visits with your doctor.~   "
132483|NCT01833221|"~     The purpose of this study is to determine the physiology of nerve healing and the~     neurotization of the facial muscles after lengthening temporalis myoplasty.~   "
132484|NCT01833208|"~     This pilot clinical trial studies the impact of radiation therapy on the immunogenicity of~     Sipuleucel-T. Patients with castration recurrent prostate cancer who are eligible for~     treatment with Sipuleucel-T and who have bone metastases are eligible.~   "
132485|NCT01833195|"~     The objective of this registry is to observe short and long term clinical outcomes in heart~     transplant recipients who receive regular AlloMap testing as part of allograft rejection~     surveillance.~   "
132486|NCT01833182|"~     Phase 1 of the study:~      Falls are the leading cause of preventable injury, long term disability, premature~     institutionalization and mortality in the older adult population. Promising preliminary~     research suggests that modifications to the home can potentially reduce the incidence of~     falls in the elderly. The purpose of this study is to gather data necessary to design a~     definitive trial of a home modification intervention for older adults at risk for fall. The~     specific aims are to 1) estimate the efficacy of an intensive tailored environmental~     intervention to reduce functional decline among community-dwelling older adults; 2) gather~     the data necessary to design a definitive clinical trial of an intensive tailored~     environmental intervention to reduce the cumulative incidence of falls among~     community-dwelling older adults; 3) examine the direct cost of intensive tailored home~     modification. A pilot randomized controlled trial will be conducted with 40 older adults who~     have experienced a fall resulting in an emergency room visit.~      Phase 2 of the study:~      Our long-term objective is to prevent falls for these older adults at high risk by removing~     hazards in their homes. Development of an effective intervention for fall reduction could~     have an immediate impact for this population and high public health significance. Intensive~     home hazard removal has been established as an effective environmental intervention for the~     prevention of falls; however, none of the published studies have been conducted in the US,~     and no study has adequately controlled for biases. The investigators propose a~     double-blinded, randomized sham-controlled clinical trial to determine the efficacy of an~     intensive tailored home hazard removal intervention to reduce the cumulative incidence of~     falls among 110 community-dwelling older adults who visit the emergency department (ED)~     because of a fall. This three year study will be the first to utilize a sham control group~     and a double-blind, randomized study design. The investigators will intervene with a~     high-risk group of community-dwelling older adults who visit an ED after a fall. The primary~     hypothesis will be tested by comparing the 12-month cumulative incidence of falls in an~     intensive tailored home intervention group with falls in a sham control group. Falls will be~     operationalized as unintentional movements to the floor, ground or object below knee level.~     The secondary hypothesis will be tested by comparing total number of falls, number of~     injurious falls, fear of falling and performance in daily activities between the intervention~     and sham control group.~      The primary aim of the proposed study is to:~        1. Compare the efficacy of an intensive tailored home hazard reduction intervention to sham~          treatment on the cumulative incidence of falls over 12 months for older adults who visit~          the ED after a fall.~           Hypothesis 1: The cumulative incidence of falls over 12 months will be lower for the~          intensive tailored home hazard removal group compared to the sham control group.~           The secondary aims of the proposed study are to:~        2. Determine if intensive tailored home hazard reduction intervention is superior to sham~          treatment on secondary outcomes including: total number of falls, number of injurious~          falls, fear of falling and activities of daily living (ADL) performance.~           Hypothesis 2: The investigators hypothesize that the intensive tailored home hazard~          reduction intervention group will experience fewer total falls, fewer injurious falls,~          less fear of falling and improved ADL performance compared to the sham control group.~        3. Characterize intensive tailored home hazard reduction interventions including the~          frequency of environmental modification by type and location in the home and its direct~          costs. The investigators will also conduct subgroup analysis of type, location and cost~          of home modifications by race and gender.~      The proposed study is innovative because it provides intensive, individualized prescriptions~     of home hazard removal and because it provides a quick response to a fall. It is also the~     first double-blind trial of the effect of environmental modification on falls and, to our~     knowledge, is the first collaboration between occupational therapy and emergency medicine on~     fall reduction strategies in the US.~      The results of the proposed study will provide new evidence about the effectiveness of~     intensive tailored home hazard removal to reduce falls. This study has the potential to~     provide public health guidelines for the delivery of home hazard removal, decrease the health~     care costs associated with falls and to provide evidence for guiding public health policy for~     older adults who have fallen.~   "
132487|NCT01833169|"~     The purpose of this signal seeking study was is to determine whether treatment with BKM120~     demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic~     malignancies to warrant further study.~   "
132488|NCT01833156|"~     In lymphedema there is increase in water content of the tissue. We studied a device~     (MoistureMeterD) which is suitable to detect water contact in the tissue. Although the~     apparatus is commercially available, no validation study had been performed in vivo with~     local edema.~      We designed a validation study for inter- and intra observer variability and the~     reproducibility in vivo by histamin induced local edema~   "
132492|NCT01833104|"~     The purpose of the study is to look at the long term effects of a complex socio-affective~     mental training program on a neuroscientific-, hormonal-, behavioral-, biological, and~     subjective measures-level. The training protocol consists of a variety of meditation and~     other mental health techniques, which are trained over the period of 3-9 months (13 weeks per~     Module; 1-3 Modules)~   "
132493|NCT01833091|"~     Effects of creating an artificial night on physiological changes, weight and feeding~     tolerance in preterm infants.~      Introduction:Nowdays,with medical advances in intensive care increased chance of survival in~     premature infants.One of the major concerns exposure to high light levels in neonate &~     subsequent it is increase in metabolism rate.So,this study was conducted to determine the~     effect of creating an artificial night on physiological changes, weight and feeding tolerance~     in preterm infants.~      Methods: This is a randomized clinical trial dual group study, 38 preterm infants~     (gestational age of 30-34weeks)due to prematurity hospitalized at Ghaem NICU,were evaluated~     within 10 days. Infants were divided into two groups of 1200-1700 and 1701-2200g based on the~     weight and the weight of each group were randomized into artificial night(dark period was~     from 19 to 7 during incubator was covered with linen cloth & light period was from 7 to 19~     removed the cover) and control groups(continuous lighting). Mothers & infants through~     questionnaires,interviews,observation & document completion, changes in physiologic & weight~     befor entering the study & then physiologic changes twice a day,weight & feeding tolerance~     were collected daily.Data were analyzed using spss v.16 software.~   "
132494|NCT01833078|"~     Frailty is a geriatric syndrome leading to physical deterioration including muscle wasting~     (sarcopenia) and unintentional weight loss. There are currently no approved therapies for~     frailty. Ghrelin is a hormone produced by the stomach that stimulates appetite centers in the~     brain. The investigators already know that a single dose of Ghrelin improves food intake~     immediately after the dose in frail older people. In this study, the investigators are trying~     to find out if repeated daily doses of ghrelin will help frail older people improve food~     intake for multiple days in a row.~   "
132495|NCT01833065|"~     12 Week Efficacy and Safety Trial Followed by a 4 Week Withdrawal Period for Patients with~     Chronic Idiopathic Constipation.~   "
132496|NCT01833052|"~     This prospective, randomized study was designed to investigate the benefit of using a~     Filter-Protection-Device (Claret MontageTM Dual Filter System) during transcatheter aortic~     valve implantation (TAVI) with a Medtronic CoreValve®.~   "
132497|NCT01833039|"~     The purpose of this study is to provide patients who have relapsed or refractory Mantle Cell~     Lymphoma (MCL) with early access to an investigational medication called ibrutinib~     (PCI-32765) and to collect safety information about the drug.~   "
132498|NCT01833026|"~     Chronic Obstructive Pulmonary Disease (COPD) is a progressive respiratory (lung) disease that~     makes it harder to breathe over time. To date, there is no cure for COPD, but it can be~     managed when diagnosed and proper medical care is provided.~      The purpose of this study is to determine if diagnosis and guided therapy with the use of~     spirometry is related to better patient outcomes (the condition of a patient's health)~     compared to usual care which may or may not include the use of spirometry. Spirometry is a~     standardized test used in medical practice that measures how much air your lungs can hold and~     how forcefully you can breathe out.~      For this study, the investigators will compare two groups: 1) intervention (treatment) group~     and 2) usual care group (control). The intervention group will have a spirometry test and the~     results will be provided to the primary care physician. The usual care group will not~     initially have a spirometry test. Both groups will be followed for outcomes.~   "
132499|NCT01833013|"~     Nowadays, one in six couples consults for fertility problems. If the standard examination and~     tests do not reveal any cause of infertility, the woman may undergo a laparoscopic~     exploration which reveals endometriosis in more than 50% of cases.~      Endometriosis is an inflammatory disease defined as the presence of endometrial tissue out of~     the uterine cavity. It is frequent (1 in 10 women) and associated with a high economic burden~     (22 billion dollars in 2002 in the USA) and important decrease in quality of life.~     Physiopathological mechanisms and risk factors for endometriosis are not well identified.~      A woman with endometriosis is 20 times more at risk of infertility. Fecundity rate of a~     25-year-old couple is about 15 to 20% in the general population and only 2 to 10% in case of~     endometriosis.~      There are many manifestations of this disease (infertility, pelvic pain) and the~     anatomo-clinical correlation is not good. The presently used international classification~     (American Fertility Society revised in 1985, AFSr) does not predict the chance of pregnancy.~     New scores such as the Endometriosis Fertility Index (EFI) have been proposed to do so, but~     need to be validated. Treatment for endometriosis-related infertility is not consensual.~      A prospective cohort study would give access to clinical data of patients followed in our~     center, so as to identify clinical factors predicting pregnancy and to help treatment~     decision for women with endometriosis suffering from infertility.~   "
132500|NCT01833000|"~     The main objective is to evaluate the interest of cerebro-splanchnic oxygenation ratio (CSOR)~     for early diagnosis of necrotizing enterocolitis (NEC) in neonates with rectal bleeding~     and/or abdominal distension. CSOR will be determined using near infrared spectroscopy (NIRS).~   "
132501|NCT01832987|"~     Rationale:~      Treatment of multidrug or extensively drug resistant tuberculosis (MDR/XDR-TB) is a real~     challenge as failure in response to treatment and serious side-effects are frequently~     encountered. New, more effective drugs with less side effects are therefore urgently needed~     to solve this problem. Although several new drugs against TB are in the pipeline, physicians~     currently have limited treatment options for treatment of complicated MDR/XDR-TB cases.~     Therefore, drugs developed and labeled for other infectious diseases are evaluated for TB.~     Co-trimoxazole consists of sulfamethoxazole and trimethoprim. Sulfamethoxazole could be~     effective in the treatment of tuberculosis as shown by Forgacs et al. and Huang et al.~      Furthermore, with dried blood spot (DBS) analysis, the exposure to co-trimoxazole could be~     analyzed with only some blood drops withdrawn with a finger prick on paper. This paper is~     suitable for storage, transportation and subsequently analysis without additional cooling or~     storage requirements.~      Objective:~      The main objective of this prospective clinical trial is to evaluate pharmacokinetics of 960~     mg co-trimoxazole in TB patients. This clinical trial will provide important information on~     PK of co-trimoxazole in TB patients for future studies.~      The second objective is to calculate the T>MIC and AUC0-24h/Minimal inhibitory concentration~     (MIC) ratio as efficacy predicting parameter. Furthermore, the analysis of dried blood spots~     will be clinically validated by comparing results of blood samples withdrawn from venous~     blood versus withdrawn by finger prick and transferred to filter paper. Retrospectively, data~     from this study can be used for limited sampling strategies for co-trimoxazole based on a~     pharmacokinetic population model constructed from the full PK curves of the patients.~      Study design:~      A prospective pharmacokinetic study.~      Study population: 12 TB patients.~      Intervention: on 4 to 6 days, 960 mg co-trimoxazole daily will be added to the normal~     treatment regimen.~      Main study parameters/endpoints:~      The pharmacokinetic parameters (Vd, Cl, AUC, etc) of co-trimoxazole are the primary endpoints~     of the study. The T>MIC and AUC0-24h/Minimal inhibitory concentration (MIC) ratio are most~     likely the best predictive parameters for efficacy of co-trimoxazole treatment and will be~     calculated for a range of M tuberculosis isolates.~   "
132502|NCT01832974|"~     IL-13-PE is a chemical similar to one made by the body that is connected to a toxin to~     specifically attack cancer cells. Researchers want to look at different doses of IL-13-PE to~     find one that may be safe and effective against cancer that has returned, spread to other~     organs, or that cannot be surgically removed.~      Participants will receive physical exams and report side effects. Blood and urine samples~     will be collected. Imaging studies, tissue samples, and other tests will be used to study the~     tumor before the start of treatment and during the study. IL-13-PE therapy will be given to~     each participant on days 1, 3 and 5 of each monthly cycle for up to 4 monthly cycles.~      The study will be done in two parts, with a six-month period between them. If the cancer~     continues to grow, participants will stop taking IL-13-PE. If the cancer continues to shrink~     or not grow the study will continue, even into a follow-up period after the second part of~     the study.~      The first part of this study will determine how much IL-13-PE can be tolerated. For this~     part, the study is recruiting adult patients with various types of cancer. After six~     participants have taken the lowest dose with no more than one experiencing dose-limiting~     toxicity, two participants may begin the study taking the medium dose. If they tolerate the~     medium dose for a month, up to four more may begin at that dose. When at least three~     participants have tolerated the medium dose, two may attempt the highest dose. When they have~     tolerated the highest dose for one monthly cycle, 1-4 more may begin the study, receiving the~     highest dose.~      Adrenal cortex cancer (ACC) is a rare tumor in the gland above the kidney. It affects only~     1-2 people per million each year and causes hormone problems. This tumor affects children~     under age 5 and adults aged 30-40, causing death within five years for up to 80% of them.~     During the second part of the study, all participants will be ACC patients. They will receive~     the highest dose tolerated during Part 1 on days 1, 3, and 5 of each monthly cycle for up to~     four months.~   "
132503|NCT01832961|"~     Chronic obstructive pulmonary disease (COPD) is characterised by airflow limitation that is~     not fully reversible, and is usually progressive and associated with an abnormal inflammatory~     response of the lungs to noxious particles or gases, most commonly cigarette smoking. The~     disease affects not only the large central airways but also the small, more peripheral~     airways deeper into the lung, defined as less than 2 mm in diameter.~      Besides medical treatment, physiotherapy plays a major role in treatment and various methods~     have been suggested to remove airway of secretions. The flutter is a simple and small device~     shaped like a pipe that creates a positive expiratory pressure (PEP) and high frequency~     oscillation when the expired air passes through it. These vibrations are thought to mobilise~     airway secretions facilitating their clearance and improving breathing.~      Standard blowing tests, like spirometry, where patients blow forcedly into a machine, have~     previously been used to investigate the efficacy of flutter devices. However, spirometry~     assesses the damage of larger airways but not small airways, also known as the silent zone~     which, crucially, are specifically damaged in COPD.~      In this study the investigators hypothesise that because the flutter helps clear the airways~     from the excessive thick mucus produced by COPD patients, these patients may find it easier~     to breathe and have lower resistance to moving air in and out of their lungs.~      The main objective of this study is to compare the effect of a flutter or a sham device on~     small airways damage using impulse oscillometry (IOS), a non-invasive method that, contrary~     to other common blowing tests, measures small airway resistance during normal breathing.~      In addition, because COPD is characterised by inflammation, the investigators would also like~     to measure a gas the patients blow out, nitric oxide (NO) the levels of which reflect airway~     inflammation. This will give to investigators an insight into the relationship between airway~     inflammation and small airway function.~   "
132504|NCT01832948|"~     This study is to assess the efficacy and safety of Endostar combined with mFOLFOX6 in~     untreated metastatic colorectal cancer patients, and to find the markers that may predict the~     efficacy.~   "
132505|NCT01832935|"~     Glycemic control is fundamental in the management of diabetes mellitus .If lifestyle~     intervention and full tolerated doses of one or two oral glucose lowering drugs (OGLDs) fail~     to achieve or sustain glycemic goals, insulin should be initiated. New insulin analogs are~     generated to improve glycemic control .New insulin analogs are generated to improve glycemic~     control,However, the cost of these analogs is a major problem .The aim of this piggy back~     evaluation was to assess the effect of Glargine insuline versus NPH plus regular human~     insulin on metabolic control as well as its cost-effectiveness in people with type 2 diabetes~     in the Iranian setting.~   "
132506|NCT01832922|"~     This is a non-randomized, open label, dose-ranging study of Bendamustine and Rituximab (BR)~     in patients with previously untreated or relapsed/refractory Chronic Lymphocytic Leukemia~     (CLL) who have multiple comorbidities with or without renal insufficiency. These agents are~     FDA approved for this indication. However, full dose bendamustine is associated with~     significant hematologic toxicity and a high rate of infectious complications in unfit~     patients and patients with significantly impaired renal function. This study will attempt to~     optimize and define adequate and safe treatment protocols for these patients with~     comorbidities and/or renal dysfunction.~      The study will accrue two independent patient cohorts which will follow a standard Phase I~     design. Patients with CLL who have significant comorbidities with or without minor renal~     dysfunction (CrCL>40 mL/min) will be accrued onto Cohort 1 of the study. Patients with~     significant renal dysfunction (CrCL<40 mL/min) will be accrued onto Cohort 2. Once the~     maximum tolerated dose (MTD) is determined, two expansion cohorts will be enrolled.~      There will be a treatment period of up to six 28-day cycles. On C1D1 all qualifying patients~     will provide samples for biomarker analysis. Six patients without renal dysfunction and 6 to~     9 patients with renal dysfunction will also provide samples for bendamustine PK analysis.~      Accrual of both patient cohorts will occur simultaneously and will take place at two centers:~     Norris Cotton Cancer Center (NCCC) and Dana-Farber Cancer Institute (DFCI). Coordination of~     accrual to the study cohorts will be centralized at NCCC by Dr. Alexey V. Danilov.~   "
132507|NCT01832909|"~     The objective of this study is to measure the energy value of walnuts in the human diet and~     study molecular mechanisms that may help explain the beneficial health effects of walnuts.~     The hypothesis is that there will be less metabolizable energy in walnuts due to decreased~     fat digestibility.~   "
132508|NCT01832896|"~     The objective of this study is to evaluate the safety and tolerability of a single~     Subcutaneous (SC) dose of Ecallantide in children and adolescents with Hereditary Angioedema~     (HAE).~   "
132509|NCT01832883|"~     The purpose of this project is to compare the performance of the Pediatric Vision Scanner~     (PVS) with the Gold Standard Examination to determine the effectiveness of the PVS at~     detecting amblyopia and strabismus.~   "
132510|NCT01832870|"~     This is a clinical trial designed to quantify the immune response and determine the~     tolerability and side effects of sipuleucel-T when given in combination with ipilimumab for~     patients with advanced prostate cancer.~   "
132511|NCT01832857|"~     This Phase II study is conducted to assess the safety and efficacy of CPI-613 in patients~     with advanced and/or metastatic solid tumors for whom there there is no available therapy to~     provide clinical benefit or for those who have refused further standard therapy. The primary~     outcome measure is Overall Survival (OS). The secondary outcome measures are: Response Rate~     (RR), Progression-Free Survival (PFS), and safety.~   "
132553|NCT01832311|"~     The purpose of this study is to compare the levels of several immunoregulatory factors in~     serums and aqueous humor of type II diabetes cataract patients with those in senile~     non-diabetic cataract patients since disturbed cytokine and growth factor microenvironment in~     diabetic eye may contribute to an increased frequency of intraoperative and postoperative~     intraocular lens surgery complications.~   "
132512|NCT01832844|"~     The aim of this care protocol is to study the effects of scan to help epidural infiltration~     realization, in presumed difficult patients suffering from sciatica.~      These scans are already performed in our Rheumatology Department but our objective is to~     evaluate objectively its contribution for patients and doctors.~      Epidural infiltration in young patients, with an easy anatomical identification, causes~     generally no technical difficulties, therefore this protocol will only include patients~     presumed to have a difficult infiltration, that means those aged more than 60, and/or with~     BMI > 30 and/or suffering from scoliosis.~      This study concerns patients who are hospitalized in Rheumatology Department (Hospital of~     Nantes) for their first epidural infiltration for treatment-resistant lombosciatica.~      Patient will be randomized at Day 0, before infiltration. This latter will be performed in~     accordance to current practice.~      Tolerance data (pain and satisfaction) will be collected just after the infiltration and~     eventual complications will be reported within 48 hours after infiltration.~      Following treatment of lombosciatic will be realized through hospitalization, as usual.~      Scan is a safe, non invasive, painless and non radiating exam. It is the extension of the~     musculoskeletal clinical exam and it has already changed our rheumatology practices. The~     investigators hope at the end of this study, that results would confirm that scan can be a~     help in practice to perform epidural infiltrations.~   "
132513|NCT01832831|"~     One out of every six men will be diagnosed with prostate cancer and post prostatectomy up to~     75% report urinary incontinence. There are many hypotheses about the exact cause of post~     prostatectomy stress incontinence (PPI). Existing studies have focused on surgical or~     cadaveric dissections to define structures responsible for PPI. Contemporary 3T MRI now~     allows three dimensional, sub-millimeter resolution of the human pelvis and clearly~     demonstrates pelvic anatomy without the distortion of dissection. It is our overarching~     hypothesis that PPI is multifactorial and occurs because of a combination of specific~     anatomical and functional impairments. We propose conducting a case control study with~     matching for age and race to compare the MRI anatomy and urinary tract function on~     urodynamics between 20 men with PPI (cases) and 20 men who are continent post prostatectomy~     (controls) who are all a minimum of 12 months post surgery. We will use static and dynamic~     MRI at 3 Tesla to make objective measurements of the bladder neck, external urethral~     sphincter, pelvic floor, urethral anastomotic fibrosis, and urethral hypermobility- all~     believed to play a large part in continence. Multi-channel urodynamic studies will also be~     performed to assess the leak point and maximum urethral closure pressure. All cases and~     controls will complete standardized questionnaires - the AUA symptom index and the~     Incontinence Severity Index as a quality of life measure. This study is needed to provide~     critical information about causes of male PPI, a quality of life altering voiding~     dysfunction, and will assist with the advancement of pharmacological and surgical treatment~     of this disease.~   "
132514|NCT01832818|"~     The objective of this study is to evaluate long-term safety and effectiveness of the NuNec®~     Cervical Arthroplasty System in a small patient population. The NuNec device is currently CE~     marked and commercially available in Europe.~   "
132515|NCT01832805|"~     50 Right-handed antidepressant-free unipolar depressed patients (age 18-65 years) will be~     treated with in total 20 Theta burst sessions; these will be spread over 4 days. On each~     stimulation day, a given patient shall receive 5 sessions with a between session delay of 10~     to 15 minutes. Patients will be selected using the structured Mini-International~     Neuropsychiatric Interview (MINI). All will be at least stage I treatment resistant. Because~     concomitant antidepressant treatment can confound outcome results, all patients will go~     through a medication washout before entering the study and they will be free from any~     antidepressant, neuroleptic and mood stabilizer for at least two weeks before entering the~     treatment protocol. Only habitual benzodiazepine agents will be allowed.~      All patients will be closely matched for gender and age with 50 never-depressed~     medication-free healthy volunteers. Only baseline measurements will be collected: no~     volunteer will undergo the treatment.~      We expect that real Theta burst treatment and not sham will result in a significant and~     clinical meaningful response.~   "
132516|NCT01832792|"~     Guided self-help (GSH) is a recommended first-step treatment for bulimia nervosa, binge~     eating disorder, and atypical variants of these disorders. The current study proposes to~     investigate the effectiveness of providing GSH either face-to-face or via e-mail, also using~     a delayed treatment control condition. Symptom outcomes will be assessed, and an estimate of~     cost-effectiveness made. Results are proposed to be disseminated locally and internationally~     (through submission to conferences and peer-reviewed journals), and will hopefully inform~     local service provision.~      Please note that we are only able to offer the intervention to individuals who are currently~     registered with a General Practitioner that is covered by Oxford Health NHS Foundation Trust~     - this is typically restricted to practices in Oxfordshire, Buckinghamshire, and parts of~     Wiltshire.~   "
132517|NCT01832779|"~     Achalasia is a chronic disease of altered esophageal motility with resulting functional~     obstruction to the passage of food leading to poor quality of life and significant morbidity.~     The two main treatments available in the US are endoscopic balloon dilation and surgical~     myotomy. Each therapy has advantages and drawbacks and at present both are considered a first~     choice approach depending on patient preferences and local expertise. Surgical myotomy~     provides long lasting improvement in dysphagia but even when done laparoscopically is~     invasive and complex. Extensive acid reflux resulting in significant morbidity is routinely~     seen after surgical myotomy and additional anti-reflux operation is typically done at the~     time of the myotomy. Endoscopic balloon dilation is a simple minimally invasive outpatient~     procedure but improvement of symptoms tends to be shorter in duration and repeat dilations~     are commonly needed. Both therapies improve on dysphagia but tend to provide suboptimal~     control of chest pain which is one of the cardinal symptoms of achalasia.~      The peroral endoscopic myotomy (POEM) was first introduced in Japan to address the suboptimal~     results with endoscopic balloon dilation and surgical myotomy. POEM is incisionless minimally~     invasive but in addition may have some further advantages over surgical myotomy including~     unlimited length of the myotomy with expected better control of chest pain and preservation~     of the anatomical anti-reflux barrier (angle of His and the cruse of the diaphragm) with~     expected lower incidence of acid reflux.~      In Japan POEM has become the preferred modality for therapy of achalasia due to the excellent~     results and exceptional safety record. In the US, dedicated POEM devices were approved by the~     FDA just recently. As a result the bulk of the published data comes from Japan and very~     little is known regarding outcomes in US population. Therefore the investigators want to~     prospectively record our experience with POEM as done as part of routine medical care in US~     population. This will be a data recording study. All patients will receive standard medical~     care and no experimental interventions will be performed.~   "
132589|NCT01831830|"~     The primary objective of this study is to evaluate the preliminary effectiveness and~     acceptability of an innovative in-home nonpharmacological intervention, the Veterans' In-home~     Program (VIP), for Veterans with mild to moderate traumatic brain injury (TBI) and their~     families. VIP is designed to promote community reintegration, improve quality of life, and~     support functioning by realigning environmental demands to match the Veteran's abilities.~   "
132518|NCT01832766|"~     Approximately 25% of people with schizophrenia abuse marijuana. These people may be using~     marijuana to self-medicate symptoms such as hallucinations (hearing or seeing things that are~     not heard or seen by others) or delusions (false beliefs i.e. people are harassing or~     persecuting them) or the depressed and anxious feelings brought on by these symptoms.~     Currently, it is unknown whether marijuana makes schizophrenia better or worse. Marijuana~     intoxication in people without schizophrenia generally causes decreased recall of words, may~     decrease reaction time and decrease inhibition. Additionally, marijuana may cause~     distractibility as demonstrated by difficulty keeping their eyes on a moving target and~     difficulty inhibiting their response to repetitive tones. However, marijuana may have~     different effects in schizophrenia. Receptors for cannabis (marijuana) are concentrated in~     the brain and maladjustment of the cannabinoid system may be associated with the difficulty~     in thinking found in schizophrenia. The proposed research project examines if clinical~     symptoms, learning, memory, inhibition and distractibility are improved or made worse by the~     acute ingestion of tetrahydrocannabinol (THC).~   "
132519|NCT01832753|"~     The purpose of this research study is to learn about the effects of treating subclinical~     hypothyroidism (SCH) with thyroid hormone replacement in children and adolescents with Down~     syndrome (DS). We hypothesize that treatment of SCH with thyroid hormone replacement will~     improve cardiometabolic health and quality of life.~   "
132520|NCT01832740|"~     The beneficial effect of nocturnal sleep on memory consolidation is well-documented in young,~     healthy subjects. Especially, periods rich in slow-wave sleep (SWS) have shown a memory~     enhancing effect on hippocampus-dependent declarative memory. Slow oscillatory activity~     typically occuring during SWS has been implicated in the consolidation effect. In this study~     we investigate if the consolidation effect can be amplified by the application of a weak~     transcranial oscillatory electric current within the frequency range of SWS in humans~     (0,7-0,8 Hz) during nocturnal SWS.~   "
132521|NCT01832727|"~     The primary objectives are as follows:~      Phase 1b:~        -  To determine the maximum tolerated dose (MTD) of oprozomib given orally, once daily, on~          2 different schedules.~        -  To evaluate safety and tolerability~      Phase 2:~        -  To estimate the overall response rate (ORR).~        -  To evaluate safety and tolerability~   "
132522|NCT01832714|"~     This study is designed to evaluate the use of a collection of tests that measure the eye~     response, balance, oculomotor and reaction time tests to aid in the diagnosis of mTBI. The~     tests use highly precise measurement tools to assess various neurologic functions. (For~     example, high-speed cameras to record eye movement, high-end motors to precisely spin and~     move the subject, comprehensive analysis to stitch together the stimulus and the response.)~      Hypotheses:~        1. A battery of oculomotor, vestibular and reaction time tests will generate variables that~          when properly weighted and run through a given multi-variant analysis, will separate the~          subjects into one of two groups, mTBI or not-mTBI.~        2. A battery of neurologic assessment tests including reaction time, vestibular and~          oculomotor tests taxing a range of neurologic functions and executed using one or more~          of the I-Portal® family of devices, will generate responses that, when used by a trained~          physician, can aid in the diagnosis of an mTBI.~   "
132523|NCT01832701|"~     Coffee is one of the most widely consumed beverages. It contains polyphenols (chlorogenic~     acids) and bioavailability of these bioactive compounds is now somewhat well understood. In~     addition, chlorogenic acids are known to be antioxidants in the cup, but reliable evidence~     remains to be observed in vivo. The objective of this trial is to understand if regular (14d)~     coffee intake may be beneficial on biomarkers of oxidative damage measured in urine and~     plasma after an acute stress caused by exercise.~   "
132524|NCT01832688|"~     A national survey in Niger found that women and children are at risk of undernutrition and~     that many pregnant women don't visit health centers during pregnancy as often as is~     recommended. The aim is to assess the nutritional and health status of pregnant women in the~     Zinder region and to understand their knowledge, attitudes and practices related to health~     and nutrition during pregnancy. In collaboration with the Medical District of Zinder the~     prenatal care services will be optimized and the programmatic impact on gestational weight~     gain and anemia prevalence will be assessed.~   "
132525|NCT01832675|"~     In this project the investigators want to compare a new anaesthetic method during upper~     gastroscopic endoscopy, compared to the traditional used method in a private clinic. The new~     method is a lozenge containing bupivacaine, and the traditional method is a lidocaine spray.~   "
132526|NCT01832662|"~     Coffee is one of the most widely consumed beverages. It contains polyphenols (chlorogenic~     acids) and bioavailability of these bioactive compounds is now somewhat well understood. In~     addition, chlorogenic acids are known to be antioxidants in the cup, but reliable evidence~     remains to be observed in vivo. The objective of this trial is to understand if regular (10d)~     coffee intake may be beneficial on biomarkers of oxidative damage measured in urine and~     plasma. A secondary objective is to understand if polyphenols isolated from coffee may be as~     beneficial as the whole beverage in reducing oxidative stress compared to placebo~   "
132527|NCT01832649|"~     The purpose of this study is to evaluate if exercise added to usual treatment improves~     cocaine dependence treatment. The primary objective of this study is to investigate if~     exercise can facilitate cocaine craving reduction. The secondary aims are to evaluate if~     exercise can reduce negative mood states, improve quality of life and facilitate abstinence~     of cocaine.~   "
132536|NCT01832532|"~     This is an open label, controlled study.~      The investigators are studying if the FDA approved diabetes medicine liraglutide (Victoza®)~     can improve sleep apnea in adults. This study is testing liraglutide in 20 adults without~     diabetes that are diagnosed with sleep apnea.The treatment group will be compared to a~     control group of 10 adults without diabetes who have sleep apnea but will not use~     liraglutide. Both groups will continue receiving standard of care for their sleep apnea as~     prescribed by their managing sleep physician throughout their study participation.~      Everyone in the study will have two study visits and one overnight sleep study for research.~     Subjects who have not had a recent sleep study but otherwise qualify for the study, will have~     an additional research sleep study to determine the baseline severity of their sleep apnea.~     The study visits include fasting blood samples and breathing tests (pulmonary function test~     and hypercapnic challenge). There will be weekly phone visits that include a questionnaire on~     sleepiness. The group that takes liraglutide will check their blood sugar two times a day~     while on the medicine.~   "
132528|NCT01832636|"~     Several host factors underlie the pathogenesis of the reciprocal cycle of childhood diarrhea~     and undernutrition in developing countries. These include intestinal inflammation, mucosal~     damage, and alterations in intestinal barrier function that lead to malabsorption, growth~     failure, and heightened susceptibility to recurrent and prolonged episodes of diarrhea.~     Recent studies from Northeast Brazil demonstrate the benefits of a novel~     alanyl-glutamine-based oral rehydration and nutrition therapy (Ala-Gln ORNT) in speeding the~     recovery of damaged intestinal barrier function in cell culture, animal models, patients with~     AIDS, and underweight children.~      Oral supplementation with Alanyl-Glutamine (Ala-Gln; 24g a day for 10 days) improves~     short-term gut integrity and weight velocity 4 months after therapy in a group of~     undernourished children from Northeast Brazil. Intervention and Mechanisms of~     Alanyl-Glutamine for Inflammation, Nutrition, and Enteropathy (IMAGINE) is a study designed~     to answer the following questions: 1) What is the lowest dose of Ala-Gln that improves~     intestinal barrier function, intestinal inflammation, and nutritional status in children at~     risk of underweight, wasting, or stunting? 2) What are the mechanisms by which Ala-Gln exerts~     these benefits?~   "
132529|NCT01832623|"~     Vitamin D is not seen anymore only as a phosphocalcic hormone, but also as having an effect~     on global health (anti-infective, anti-inflammatory, anti-tumour roles and cardiovascular~     protection).~      The link between vitamin D deficiency and osteomalacia lesions is well-known. In paediatrics,~     systematic vitamin D supplementation of infants and toddlers, associated with milk~     enrichment, has allowed an almost total disappearance of rickets. Vitamin D repletion was~     defined as the minimal concentration that enables the prevention of rickets in children and~     osteomalacia in adults, that is approximately 8 ng/mL (20 nmol/L). However, in 2010, most of~     the international experts agreed to set minimal threshold of 25 OH vitamin D serum~     concentration, higher than the one previously admitted, with a limit of 20 ng/mL (50 nmol/L)~     to define a vitamin D deficiency and a limit of 30 ng/mL (75 nmol/L) to define vitamin D~     insufficiency in adults. In the paediatric population, the consensus is less obvious and we~     consider that a serum concentration of minimum 20 ng/mL is necessary.~      A study on more than 200 children from Lyon, followed in the paediatric nephrology unit and~     having a renal function normal or sub-normal, demonstrated an important prevalence of vitamin~     D deficiency (75%) in adolescents and pre-adolescents.~      Concurrently, the appearance of new bone imaging techniques (especially high-resolution~     peripheral quantitative computed tomography HR-pQCT) improved bone status evaluation in a~     non-invasive manner.~      Given the new pathophysiological data on pleiotropic role of vitamin D (bone, cardiovascular~     system, adipose tissue) and given the proportion of French children possibly suffering from~     vitamin D deficiency, it seems urgent to actualize current recommendations regarding~     systematic supplementation in vitamin D. This transversal study on 200 healthy children and~     adolescents will allow to have an overview of vitamin D status in French healthy children and~     adolescents, studying with non-invasive, safe, reliable and innovative tools, the theoretical~     targets of vitamin D (bones, cardiovascular system and nutritional status); and then to lay~     the foundations of therapeutic trials aiming to evaluate the mode of vitamin D~     supplementation for healthy children and adolescents; while having a cohort for HR-pQCT~     measurements, that will allow us to have French reference range in a 10-17 year-old~     population, for this innovative, non-invasive and low radiation exposure technique.~   "
132530|NCT01832610|"~     Patients will be approached to participate in this PAS after the HeartWare® Ventricular~     Assist System receives PMA approval for the indicated use as a bridge to cardiac~     transplantation.~   "
132531|NCT01832597|"~     The purpose of this study is collect and evaluate the clinical experience reached in Italy on~     the use of bendamustine alone or combined with rituximab as treatment of patients with~     relapsed or refractory chronic lymphoproliferative disorders.~   "
132532|NCT01832584|"~     This is a 3-arm double blind placebo controlled study to investigate the effect of Red Grape~     Cell (RGC) powder containing all the matrix of polyphenols that can be found in red grapes.~     polyphenols have several beneficial effects on various body systems, are present in many~     edible foods, and are considered safe for human consumption by regulatory authorities. Animal~     and human studies suggest a potential for polyphenol-rich compounds in enhancing~     mitochondrial activity and exercise capacity. However, the effect of RGC on exercise~     performance in humans had not yet been tested. A special population where increasing~     performance is highly sought are competitive athletes. The aim of the current study is to~     investigate the effect of RGC on measures of aerobic fitness, body composition and mood in~     trained male cyclists~   "
132533|NCT01832571|"~     This pilot, open-label, prospective study will determine the feasibility of integrating~     pre-exposure prophylaxis (PrEP) into existing HIV prevention programs for female sex workers~     and if women who are enrolled in those programs will adhere to the daily PrEP regimen of~     Truvada®. This study will enroll 500 HIV antibody negative female sex workers in Eldoret and~     Nairobi, Kenya.~   "
132534|NCT01832558|"~     In a prospective single centre placebo-controlled trial over ten weeks, 24 CKD II-III~     patients (eGFR 30-89 ml/min per 1.73 m2) with DM II will be randomized to enalapril 20mg per~     day after a two week run-in phase. Thereafter, patients will either receive eplerenone 25mg~     (n=12) or a placebo (n=12) for eight weeks. Eplerenone will be increased to 50mg under close~     monitoring of serum potassium levels. Employing a novel mass-spectrometry ( MS)-based method,~     quantification of up to 10 different Ang metabolites (Ang I, Ang II, Ang 1-7, Ang 1-9, Ang~     2-10, Ang 1-5, Ang 2-7, Ang 3-7, Ang 3-8 and Ang 2-8) will be performed simultaneously out of~     blood sera (after run-in phase and after 10 weeks).~   "
132535|NCT01832545|"~     The aim of PICO study is to design an aquatic exercise program specific for obese individuals~     with knee osteoarthritis which the main goals are OA symptoms management and the improvement~     of physical fitness. The author's opinion is that the musculoskeletal pain is the main~     constraint for any kind of mobility and its control should be considered as an important goal~     in the weight management's programs. Therefore the PICO project proposes an aquatic exercise~     program to controlling pain and other symptoms management, showing that it is possible to~     live with the disease, and motivating the change in lifestyle, thus preventing the~     installation or worsening of KOA. In this way, five hypotheses were formulated: H1. 3 months~     of aquatic exercise is enough to improve KOA symptoms and functionality in obese individuals;~     H2. The gait parameters of obese individuals with KOA can be improved by aquatic exercise;~     H3. Beyond the exercises skills, aquatic exercise group classes can work with an educational~     component, promoting lifestyles changes. H4: Pain reduction and a better psychological status~     can lead an increase of functionally, increasing amount of physical activity. H5: Even if the~     main goal is not weight management, the aquatic exercise program can lead a weight reduction~     or body composition change.~   "
132552|NCT01832324|"~     The Study examines the molecular basis of food allergy. It explores the interaction between T~     cells, InKT cells and cytokines in the development of food allergy. The study also explores~     these factors in development of tolerance outgrowing food allergy. It will also explore the~     genetic factors that lead to the development of food allergy.~      The study examines all type of food allergy including IgE mediated reactions, Eosinophilic~     Esophagitis and Food Protein Induced Enterocolitis~   "
132537|NCT01832519|"~     Our research is comparing the lungs of babies and young children with CF (cystic fibrosis) to~     those without CF. We are looking at the blood flow in the lungs to help doctors better~     understand how CF damages lungs and how to prevent this damage in the future. We will use MRI~     (Magnetic Resonance Imaging) and special blood tests as ways to understand early changes in~     the lungs of babies and young children with CF. We will look at the special blood tests to~     see if they can work as signals for the doctors to better understand when changes are~     happening in the lungs.~      For the babies with CF, we will compare MRI images of the lungs to their CT images (also~     sometimes called CAT scans or Computerized Tomography). We hope that this study will help us~     reduce the number of X-rays and CT scans children with CF might get in the future. Because~     MRI's do not use radiation, this could reduce the amount of radiation exposure that children~     with CF would get over their lifetime.~   "
132538|NCT01832506|"~     This is a Japanese multicenter, open-label, Phase 1 study to evaluate safety and efficacy of~     MSC2156119J in subjects with malignant solid tumor which is refractory to standard therapy or~     to which no effective standard therapy is applicable.~   "
132539|NCT01832493|"~     The Sensor Optimization of Cardiac Resynchronization Therapy (CRT) Response (SOCR) Study is a~     multicenter, prospective, non-randomized acute feasibility study that is being conducted to~     determine if subcutaneous heart sounds and/or intracardiac impedance can acutely identify the~     optimal atrioventricular (AV) pacing intervals and optimal left ventricular (LV) electrodes~     in patients indicated for cardiac resynchronization therapy.~   "
132540|NCT01832480|"~     The overall goal of this project is to determine the influence of patient treatment and host~     factors on repeat Trichomonas vaginalis (TV) infections among HIV-negative women~   "
132541|NCT01832467|"~     To determine the objective overall response of re-treatment with cetuximab-based chemotherapy~     in patients upon disease progression while under observation, who had previously responded to~     first-line or second-line treatment with cetuximab-based chemotherapy for metastatic~     colorectal cancer (mCRC), but had stopped treatment for reasons other than disease~     progression.~   "
132542|NCT01832454|"~     This Study is Single arm, Single Centre trail to check the safety and efficacy of bone marrow~     derived autologous mononuclear cells(100 millions per dose )trial to be conducted for 36~     months in 100 patients ( below 15 years of age) with cerebral palsy in India. Primary outcome~     measures are improvement in walking ability and kinetic gait pattern.~   "
132543|NCT01832441|"~     This study is Single arm, Single Centre trial to check the Safety and Efficacy of Bone Marrow~     Derived Autologous mono nuclear cells (100 Million per dose).trial to be conducted for 36~     months in patients with diabetes Mellitus in India,Primary outcome measure are abolition or~     reduction of insulin by>50 percentage by the end of 6 months of ABMSCT-Any reduction in~     requirement of Insulin dosage and Improvement in HbA1C Level.~   "
132544|NCT01832428|"~     This study is single, centre trial to study the safety and efficacy of Bone marrow derived~     autologous MNCS(100 million per dose)trial to be conducted for 36 months in stroke patients ,~     the primary outcome measure will be the improvement in muscle power of Body and face~   "
132545|NCT01832415|"~     The French cooperative group GINECO proposes to implement an observational study to describe~     a real situation, in daily practice tolerance and methods of administration of bevacizumab~     (Avastin ®)~   "
132546|NCT01832402|"~     The goal of this clinical research study is to learn if fentanyl nasal spray can help to~     control shortness of breath in patients who have been treated or are being treated for~     cancer.~      Fentanyl is commonly used for treatment of cancer pain. It may help patients with their~     shortness of breath as well.~      In this study, fentanyl will be compared to a placebo. A placebo is not a drug. It looks like~     the study drug but is not designed to treat any disease or illness. It is designed to be~     compared with a study drug to learn if the study drug has any real effect.~   "
132547|NCT01832389|"~     The objective of this study is to determine whether a goal-directed therapy can reduce the~     incidence of delayed cerebral ischaemia after aneurysmal subarachnoid haemorrhage.~   "
132548|NCT01832376|"~     Study population: Subjects with long standing symptoms from calcific tendonitis,~     non-responsive to other forms of conservative treatment~      Study method: A cohort of 50 patients with symptomatic calcific tendonitis will be treated by~     ultrasound-guided needle lavage. At baseline all study subjects will be assessed by clinical~     examination, imaging of the shoulder by x-ray and sonography and by the self-report section~     of the American Shoulder and Elbow Surgeons score (ASES). Follow-up will be performed after 1~     and 4 weeks (score only), 3 (clinical, score, ultrasound, x-ray), 6 and 12 months (score~     only), and after 24 months (clinical, score, ultrasound, x-ray). Patients with insufficient~     treatment effect will be offered physiotherapy, re-lavage or surgical treatment by~     acromioplasty.~      Purpose of the study: The investigators want to find out~        -  if shoulder function, measured by a shoulder score, will increase during follow-up~        -  how much of the calcific material can be aspirated (in ml)~        -  to which extend the calcific deposit disappears on x-rays and sonographic images~        -  how many patients will need surgical treatment~   "
132549|NCT01832363|"~     The purpose of this study is to determine if the bronchial thermoplasty treatment can be~     guided through hyperpolarized xenon lung MRI.~   "
132550|NCT01832350|"~     The primary objective of this study is to test the hypothesis that Nuedexta (20/10)~     administered orally will reduce Pseudobulbar Affect (PBA) frequency and severity~     (CNS-Lability Scale and PLACS), with satisfactory safety and high tolerability in patients~     with Alzheimer's Disease (AD). The primary objective will be evaluated using a study endpoint~     at 1, 13, 26 weeks after initiation of treatment. The secondary objective of this study is to~     evaluate the benefit of treatment with Nuedexta (20/10) on cognition and functionality as~     demonstrated in the Rey Auditory Verbal Learning Test (RAVLT), Trail making A and B, Wechsler~     Memory Scale (WMS) logical memory and delayed recall, Controlled Oral Word Association~     (COWA), Clinical Dementia Rating (CDR), Neuropsychiatric Inventory (NPI), Alzheimer's Disease~     Cooperative Study Activities of Daily Living Inventory (ADCSADL) and the 11-item Alzheimer's~     Disease Assessment Scale-Cognitive subscore (ADAS-Cog11).~   "
132551|NCT01832337|"~     Remote ischaemic preconditioning may confer the cytoprotection in critical organs. The~     investigators hypothesized that limb remote ischemic preconditioning (RIPC) would reduce~     heart and gastrointestinal function injury in middle-aged and elderly patients undergoing~     elective laparoscopic colorectal surgery.~   "
132554|NCT01832298|"~     RATIONAL: Simmitecan is an anticancer ester prodrug, which involves activation to~     chimmitecan. Chimmitecan，a novel CPT derivative, exhibited potent antitumor activities both~     in vitro and in vivo by inhibiting topoisomerase I. Also exerted comparable effects on~     topoisomerase I compared with topotecan and SN38 and possessed improved anticancer potency~     and pharmacologic profiles, compared with the clinically available CPT analogues.~      PURPOSE: to determine the maximum tolerated dose, the safety profile and pharmacokinetics of~     Simmitecan.~   "
132555|NCT01832285|"~     The purpose of this study is to determine effect of Fluvoxamine augmentation on cognitive~     function , aggressive behavior , clinical symptoms and mRNA (messenger ribonucleic acid) and~     protein expression in human peripheral mononuclear blood cells (PMC) in medicated~     schizophrenia patients~   "
132556|NCT01832272|"~     This study is aimed to determine the efficacy and the safety of the tourniquet reinflation~     after early tourniquet release in total knee arthroplasty, compared to the method of early~     deflation without reinflation. The investigators hypothesized that the reinflation after~     early release of the tourniquet would be effective in terms of improved visualization of the~     surgical field and decreased operation time and blood loss, whereas it would increase~     tourniquet-related complication due to longer tourniquet-use time.~   "
132557|NCT01832259|"~     The area around a tumor (pre-metastatic niche) may be an area to which cancer cells are~     attracted. The study doctor will take blood and tumor samples to look for certain features~     linked with response to treatment so that they can predict which future patients may benefit~     from this therapy. The purpose of this study is to see if the drug pazopanib can be used to~     reduce the amount of pre-metastatic niche in the patient's lymph nodes (a common site for~     prostate cancer to spread). Down the line, this may help to prevent prostate cancer from~     coming back after surgery.~   "
132558|NCT01832246|"~     The accurate prediction of depth of tumor invasion in early gastric cancer is essential for~     the proper selection of candidates for endoscopic resection. Conventional endoscopy and~     endoscopic ultrasonography have been useful diagnostic method for depth of invasion in early~     gastric cancer. However, there has been no prospective comparative study on the accuracy~     between the 2 methods. Therefore, the investigators prospectively compare the accuracy~     between the 2 methods regarding prediction of depth of invasion.~   "
132559|NCT01832233|"~     People with hypertension are at a higher risk for cardiovascular disease and death so it is~     important to lower blood pressure to normal levels as quickly as possible. Previous research~     has established that renal nerve denervation successfully lowers blood pressure measured in~     the arm in the physician's office. This study is being conducted so that the investigators~     can determine whether renal nerve denervation also helps to lower blood pressure over 24~     hours, as well as central aortic blood pressure, which is pressure exerted by the aorta~     closer to the heart and may be a better predictor of cardiovascular problems. The~     investigators also want to know whether these beneficial effects on blood pressure can last~     up to 2 years, whether renal denervation reduces the number of medications patients need to~     take, and whether it reduces glucose and insulin levels in the blood since hypertension is~     also related to obesity and diabetes.~   "
132560|NCT01832220|"~     This project is designed to examine the interaction between the microflora in the lower~     airway and the concentration of a serum protein called alpha-1 antitrypsin. The hypothesis is~     that alpha-1 antitrypsin impacts the diversity and content of the lower airway microflora,~     resulting in a less inflammatory airway.~      The Specific Aims are:~        1. To compare the lower respiratory tract microbiome and virome population diversity and~          content in age and GOLD stage matched PiZZ individuals not receiving augmentation~          therapy, PiZZ individuals on augmentation therapy, PiMZ individuals not receiving~          augmentation therapy, and PiMM individuals with chronic obstructive pulmonary disease~          (COPD).~        2. Determine correlations between bronchoalveolar lavage (BAL) and peripheral blood gene~          expression patterns and patterns in lung microbial and viral populations across all~          cohorts.~        3. Correlate the presence or absence of computed tomography (CT) bronchiectasis and~          bronchiolectasis with patterns in the microbiome population diversity and content.~        4. To identify and define novel molecular phenotypes of Alpha-1 Antitrypsin Deficiency~          (AATD) based on computational integration of clinical, transcriptomic, and microbiome~          data.~   "
132561|NCT01832207|"~     Background The purpose of the present controlled clinical trial was to assess the effect of a~     single 60 min application of transcutaneous electrical nervous stimulation (TENS) at sensory~     stimulation threshold (STS), compared to the application of motor stimulation threshold (MTS)~     as well as to untreatment, on the surface electromyographic (sEMG) and kinesiographic~     activity of patients with temporomandibular disorder (TMD). Methods Sixty female subjects,~     selected according to the inclusion/exclusion criteria, suffering from unilateral TMD in~     remission were assigned to MTS, STS or untreatment. Pre- and post-treatment differences in~     the sEMG activity of temporalis anterior (TA), masseter (MM), digastric (DA) and~     sternocleidomastoid muscles (SCM), as well in the interocclusal distance (ID), within group~     were tested using the Wilcoxon test, while differences among groups were assessed by~     Kruskal-Wallis test; the level of significance was set at p ≤ 0.01.~   "
132562|NCT01832194|"~     There are no previous reports on the use of Onabotulinum Toxin A to treat men with scrotal~     pain that we found published. We propose a pilot study to use Botox to block the testicular~     nerves on a group of 15 men with chronic scrotal pain who have failed the standard medical~     therapy. The men must have had temporary relief from a testicular cord block using marcaine.~     Before and 1 month, 3 months and 6 months after the Onabotulinum Toxin A injection, the men~     would be asked to fill in visual analog scales for pain, a quality of life assessment, a~     depression index (MDI) and Chronic Epididymitis Symptom Index (CESI). They will also be~     subject to sensory testing of the scrotum before, after 1 month, 3 moths and 6 months.~   "
132586|NCT01831869|"~     Subclinical hypothyroidism (SCH) is a common condition affecting 3-10% of the general~     population, especially in women older than 50 years old. It is controversial whether SCH can~     lead to increased risks of cardiovascular (CV) disease and whether treatment with L-thyroxine~     reverses these risks. The present study was designed to evaluate the effect of L-thyroxine~     treatment in SCH on lipid profile, atherosclerosis, endothelial function, serum inflammatory~     factors and adipocytokines.~   "
132563|NCT01832181|"~     The prevalence of diabetes in pregnancy is rising in all maternal age groups. There is~     increasing evidence that in-utero exposure to maternal diabetes is associated with an~     increased risk of obesity and type 2 diabetes in children and adults. There is an urgent need~     to reduce these increasing rates of obesity and diabetes in subsequent generations.~      The MiTy Trial (Metformin in Women with Type 2 Diabetes in Pregnancy Trial) is a CIHR-funded~     multi-centre, randomized controlled trial of women with type 2 diabetes in pregnancy (sample~     size n=500). The MiTy Trial is looking to determine the effect of the addition of metformin~     to a standard regimen of insulin in women with diabetes, on perinatal morbidity and~     mortality.~      The MiTy Kids Trial is a follow-up to the MiTy Trial which will determine whether treatment~     with metformin during pregnancy in women with type 2 diabetes will lead to a reduction in~     adiposity and improvement in insulin resistance in the offspring of women with diabetes at 2~     years of age.~   "
132564|NCT01832168|"~     The purpose of this study is to determine whether the AmnioFix dehydrated human amniotic~     membrane is effective in protecting nerves in men receiving robotic assisted laparoscopic~     prostatectomies.~   "
132565|NCT01832155|"~     The study hypothesized that it is feasible and safe to use Hatha yoga in older women with~     knee osteoarthritis (OA), and practicing Hatha yoga regularly will help reduce pain and~     stiffness, enhance physical function, and improve quality of sleep and quality of life in~     older women with knee OA.~   "
132566|NCT01832129|"~     In this study, biomarker response after supplementation with oral and intramuscular vitamin~     B12 will be compared in a randomized clinical trial. Electronic compliance monitoring will be~     used to control for non compliance as a possible confounder in oral treatment. Additionally~     subjective acceptance in terms of presumed preferences will be compared with oral vs.~     intramuscular supplementation of vitamin B12 in the view of the patient.~   "
132567|NCT01832116|"~     The purpose of this multicenter imaging sub study is to evaluate the biodistribution and~     organ pharmacokinetics of 89Zr-MMOT0530A in patients with unresectable pancreatic or~     platinum-resistant ovarian cancer. MMOT0530A is a monoclonal antibody that targets an antigen~     overexpressed in pancreatic and ovarian cancer. Subsequent to imaging with 89Zr-MMOT0530A,~     patients will be treated with DMOT4039A in the DMO4993g protocol (clinicaltrials.gov~     identifier NCT01469793) after this study. DMOT4039A is an antibody-drug conjugate composed of~     the monoclonal antibody MMOT0530A and the mitotic agent monomethyl auristatin (MMAE). By~     imaging patients with the monoclonal antibody MMOT0530A before treatment, the correlation~     between tumor uptake of 89Zr-MMOT0530A and response to DMOT4039A therapy will be assessed.~   "
132568|NCT01832103|"~     The primary purpose of this study is to obtain a preliminary pharmacokinetic profile of~     MK-7145 2 mg immediate release (IR) following single-dose administration in male participants~     with moderate renal insufficiency. In addition, the study will evaluate the pharmacodynamic~     effect of a single dose of MK-7145 2 mg IR on 24-hour net natriuresis in male participants~     with moderate renal insufficiency.~   "
132569|NCT01832090|"~     The purpose of this study is to assess the safety and effectiveness of Radiesse® Injectable~     Dermal Filler for hand treatment.~   "
132570|NCT01832077|"~     To evaluate the impact of telemedicine system in rural hospitals for diagnosis and treatment~     of Diabetes retinopathy and Diabetes macular edema.~   "
132571|NCT01832064|"~     The development and pilot testing of a self-management program that would be delivered in a~     one time mailing.~   "
132572|NCT01832051|"~     Information about the presence of human epidermal growth factor receptor 2 (HER2) in tumor~     lesions in breast cancer patients is essential for diagnostic and therapeutic management of~     metastatic breast cancer. In daily practice however, obtaining a metastasis biopsy can be~     difficult or impracticable. Therefore, clinicians can be faced with a persistent clinical~     dilemma in some breast cancer patients, leading to suboptimal therapy decisions due to lack~     of HER2 receptor information. Circulating tumor cells (CTCs), which may provide additional~     information, have so far not been able to replace the biopsy. To solve this problem,~     non-invasive whole body visualization and quantification of HER2 expression by means of the~     HER2-PET may be a valuable tool.~      In this prospective multicenter imaging study, eligible patients will receive one HER2-PET~     and CTC analysis in addition to standard work up for metastatic disease. Subsequent~     administration of anti-HER2 therapy will be evaluated. Referring physicians fill in three~     questionnaires, one before HER2-PET and two after HER2-PET.~   "
132573|NCT01832038|"~     The purpose of this trial is to evaluate the safety and tolerability of long-term~     administration of Lacosamide at doses up to 400 mg/day in Japanese and Chinese adults with~     Epilepsy who have completed the Treatment and Transition Period of EP0008 [NCT01710657]~   "
132574|NCT01832025|"~     Sinus augmentation, also referred to as a sinus lift or a sinus graft, is an oral surgery~     procedure where bone is added to the upper jaw near the molars. The goal of the surgery is to~     add enough bone material onto the upper jaw to support the placement of a dental implant. The~     augmentation and the dental implant placement will be done at the same time to avoid the need~     for two surgeries. This is standard of care.~      The purpose of this study is to compare any problems and patient comfort levels following~     surgery. Subjects will be randomly placed into one of two groups: the internal lift group or~     the external lift group. Both types of surgery are routinely done at our clinic. Usually the~     type of procedure (internal or external) is based on the dentist's preference. Investigators~     are doing this study to compare them to each other to see if one is more comfortable for the~     subject than the other or if they are equal. It is predicted that the two techniques may~     differ when it comes to complications during the procedure, patient discomfort following the~     procedure and patient complications in the weeks and months after the procedure. This last~     comparison has not yet been studied, and surgeons often choose the technique that they prefer~     from their own experiences. With this research study researchers hope to gain valuable~     information that will help surgeons' decisions in the future.~        -  Investigators hypothesize that external sinus augmentation with simultaneous implant~          placement (external technique) will have a higher rate of Schneiderian membrane~          perforation than the internal sinus augmentation with simultaneous implant placement~          (internal technique).~        -  Investigators hypothesize that the internal technique is associated with more discomfort~          for the subject compared with the external technique.~        -  Investigators hypothesize that the external technique will result in more severe~          pain/bleeding/swelling than the internal technique.~        -  Investigators hypothesize that the internal technique has a higher incidence of~          complications that occur between three weeks and three months postoperatively compared~          with the external technique.~        -  Investigators hypothesize that the external technique has a higher amount of analgesics~          taken postoperatively compared with the internal technique~   "
132575|NCT01832012|"~     175 second year medical students were assessed on their BLS CPR skill retention after an~     approximate one year after taking the initial certification class, and the investigators~     assessed which type of refresher course would be most effective in improving the students'~     CPR skills. Group 2 had no refresher, Group 3 had a multimedia refresher, and Group 4 had the~     same multimedia refresher plus hands on practice on a Laerdal BLS manikin. The investigators~     hypothesized that Group 4 would perform CPR skills with the highest competency compared to~     the other two groups.~   "
132576|NCT01831999|"~     Building on the recent advances in telephone supported care, clinical monitoring, and~     outreach work, the specific aims of the study are to:~        1. Develop RecoveryTrack™- ExtendedCare (RT-E), a modified/new version of RecoveryTrack™.~          The investigators will adapt and finalize the original Web-based RT system, manual, and~          training to accommodate use by counselors for clients who are no longer attending~          Outpatient (OP) treatment.~        2. Conduct a pilot study to determine the preliminary efficacy of RT-E compared to~          treatment as usual (TAU) for clients entering Intensive Outpatient (IOP) substance abuse~          treatment (SAT). In this randomized clinical trial, it is hypothesized that RT-E will~          positively impact treatment attendance and substance use outcomes. In exploratory~          analyses, the investigators will also evaluate the comparative impact of RT-E versus TAU~          on HIV related client behaviors.~        3. Evaluate feasibility and counselor and client acceptability of RT-E.~        4. Conduct preliminary cost and cost effectiveness analyses comparing RT-E to TAU.~      Hypothesis 1: RT-E clients will attend more days of OP treatment than TAU clients. The~     investigators will compare the two groups on monthly treatment attendance for months 1~     through 9. We expect a main effect of group with RT-E clients displaying more attendance than~     TAU clients.~      Hypothesis 2: RT-E clients will have higher rates of abstinence than TAU clients. The~     investigators will compare abstinence rates at months 3, 6, and 9. Abstinence is a binary~     variable based on both biological test results and self-reported substance use from the~     Addiction Severity Index, Version 6 (ASI6). We expect a main effect of group with RT-E~     clients displaying higher rates of abstinence than TAU clients.~      Secondary Analyses:~      HIV Risk Scores: The investigators will compare the two groups' Risk Assessment Battery (RAB)~     HIV risk scores (i.e., total, sex, drug) at month 9.~      Use of HIV specialist services: Client attendance charts will be reviewed to compare the two~     groups on the number of times clients met with a program HIV Specialist at month 9.~      Multidimensional Outcomes: The investigators will compare RT-E and TAU clients on~     multidimensional outcomes using ASI6 summary scores at months 3, 6, and 9.~   "
132577|NCT01831986|"~     Schizophrenia (SZ) and schizoaffective (SA) disorders are comprised of several debilitating~     symptoms. It was suggested that compounds with neuroprotective effects might be useful in the~     management of SZ/SA symptoms. Our previous clinical trials indicated significant beneficial~     effects for augmentations with two different neuroprotective agents: Pregnenolone and~     L-Theanine. Pregnenolone (PREG) is a neurosteroid, which displays multiple effects on the~     central nervous system. Our recent 8-week, randomized, double-blind trial among patients with~     chronic SZ/SA disorders, in which PREG versus placebo and DHEA was added to antipsychotics,~     yielded encouraging results: PREG augmentation demonstrated significant amelioration of~     positive symptoms, EPS, as well as an improvement in attention, and working memory~     performance of SZ/SA disorder patients (Ritsner et al 2010). L-Theanine is a unique amino~     acid present almost exclusively in the tea plant. It possesses neuroprotective,~     mood-enhancing, and relaxation activities. L-theanine augmentation to antipsychotic therapy~     can ameliorate positive, activation, and anxiety symptoms in SZ/SA disorder patients (grant #~     06TGF-911, (Ritsner et al 2010). This proposed study would extend our prior research with~     Pregnenolone and L-theanine by combining both agents versus placebo. We hypothesized that~     addition of both these compounds to ongoing antipsychotics would significantly improve the~     clinical status of SZ/SA patients.~      Methods: In an 8-week, randomized, double-blind placebo-controlled trial a combination of~     PREG (50 mg/day) with L-theanine (400 mg/day) versus placebo will be added to the stable~     ongoing antipsychotic treatment of 200 patients with schizophrenia or schizoaffective~     disorders. This trial will be conducted at five sites in Israel. Participants will be~     assessed at baseline and after 2, 4, 6 and 8 weeks of treatment. A battery of research~     instruments will be used for the assessment of psychopathology, side effects, general~     functioning and quality of life~   "
132578|NCT01831973|"~     INVESTIGATIONAL PRODUCT:~      TLC388 (Lipotecan*) *Lipotecan is a drug product of TLC388 HCl.~      PHASE OF DEVELOPMENT:~      Phase II~      No. OF PATIENTS:~      Approximately 40 (Stage I: 15 evaluable patients, Stage II: 25 evaluable patients)~      STUDY OBJECTIVES:~      Primary~      • To evaluate non-progression disease (non-PD) rate at the end of cycle 6~      Secondary~        -  To evaluate progression free survival (PFS)~        -  To evaluate overall survival (OS)~        -  To evaluate the duration of non-PD~        -  To evaluate objective response rate (ORR; where ORR= CR+PR) and duration~        -  To evaluate the safety profile of TLC388~        -  To evaluate change in health-related quality of life (HRQOL) at the end of cycle 6~      STUDY DESIGN:~      This is a Phase II, open-label, single-arm, multi-centre study to evaluate TLC388 monotherapy~     in patients with locally advanced and/or metastatic renal cell carcinoma (RCC).~   "
132579|NCT01831960|"~     This study is designed to determine the hypothalamic-pituitary-adrenal (HPA) axis suppression~     potential and pharmacokinetic (PK) properties of CB-03-01 Cream, 1%, applied every twelve~     hours for two weeks, in subjects with acne vulgaris ages 12 years or older.~   "
132580|NCT01831947|"~     This clinical trial investigates the impact of intravitreal injection of Ranibizumab antibody~     on the acuteness of vision. Patients included are suffering from choroidal~     neo-vascularization (CNV) as a consequence of age-related macular degeneration (AMD).~      Initially, all patients get injections of 0.5 mg Ranibizumab in monthly intervals for 3~     months. Subsequently, one group gets Ranibizumab in intervals of 2 months, whereas a second~     group is treated on demand.~      The primary end point of the study is the change of best-corrected visual acuity after 12~     month.~      Secondary end points include the impact of Ranibizumab on morphological changes of the~     retina, the number of patients with gain or loss of 15 or more letters visual acuity after 12~     months, changes in quality of life and the number of injections required during the first 12~     months of treatment.~   "
132581|NCT01831934|"~     This pilot clinical study evaluated the safety and metabolic responses to a licensed~     inactivated seasonal influenza vaccine (TIV) in mitochondrial encephalopathy, lactic~     acidosis, and stroke-like episodes syndrome (MELAS) volunteers and controls.~   "
132582|NCT01831921|"~     The investigators plan to test two different strategies for weight loss and diabetes~     prevention in the Latino community in and around Forsyth County, NC. The study is designed to~     test the hypothesis that a lifestyle weight-loss program implemented within the Latino~     community will have a more beneficial and clinically meaningful impact on HbA1c, insulin~     metabolism, and markers of the metabolic syndrome when compared to an enhanced usual care~     condition. This lifestyle intervention will include group-based sessions promoting healthy~     eating, increased physical activity and weight loss. These sessions will be delivered by lay~     community members, known as Latino Health Advisors (LHAs). The enhanced usual care group will~     consist of individual counseling with are registered dietitian and uses existing community~     resources to assist participants in making healthier lifestyle choices.~   "
132583|NCT01831908|"~     Persons voluntarily attending the Community Center of the Atahualpa Project during one~     calendar year will be evaluated by trained personnel to check their cardiovascular health~     status. A chart with information of healthy behaviors as well as the numbers of the person's~     blood pressure, fasting glucose, and total cholesterol levels will be given. Persons who sign~     the informed consent will be visited at their homes after 3 months and than every year up to~     five years. The idea is to check whether the person followed our advises and if that~     compliance iis associated with improvement in the cardiovascular status or with a decreased~     incidence of stroke and ischemic heart disease, when compared with persons who did not attend~     the community center or those who did not follow our advices.~   "
132584|NCT01831895|"~     To evaluate the safety and performance of the MobiusHD system in subjects with resistant~     hypertension.~   "
132585|NCT01831882|"~     The primary objective of this study is to investigate the biological components of major~     depression. The investigators are particularity interested in genetic variation and how it~     contributes to cortisol (because cortisol is higher in severe depression than mild depression~     or healthy controls) and how it contributes to clinical symptoms, especially suicidal~     ideation/behavior and psychosis.~   "
132591|NCT01831804|"~     This is a randomized, placebo-controlled, single-blind (subjects and investigators will be~     blinded, GSK internal personnel will not be blinded), parallel-group, two part (Part A, Part~     B) trial in healthy volunteers and subjects with diabetic foot ulcers. Part A is designed to~     evaluate single applications of GSK1278863 in one cohort of healthy volunteers (intact skin)~     and approximately 3 cohorts of diabetic subjects. Part B is designed to evaluate first~     single, and then repeat applications of GSK1278863 in diabetics, both in the clinic and by~     subjects at home. Part B will include approximately 3 cohorts in which the concentration of~     drug applied will be determined by pharmacokinetic data from Part A and earlier cohorts in~     Part B.~   "
132592|NCT01831791|"~     This is a multicentre, open-label study to assess the safety, tolerability, and efficacy of~     0.5 mg Dutasteride administered once daily for 52 weeks in men with Androgenetic Alopecia~     types III vertex, IV and V per the Norwood-Hamilton classification. The study consists of a~     Screening Phase (3 weeks prior to Baseline) and a Treatment Phase (52 weeks). A subject who~     completes the full course of study treatment and the final study visit (Week 52; Visit 7)~     will be considered as study completion.~   "
132593|NCT01831778|"~     The Breast Cancer Surveillance Consortium (BCSC) database contains data from 1994-2009 on~     breast cancer screening, quality, and outcomes, and its main goal is to advance breast cancer~     research. This project is funded to maintain the BCSC database and share the data with~     investigators. Our objectives are to:~        -  Maintain the BCSC pooled database using secure methods that protect the confidentiality~          of women, radiologists, facilities, and BCSC registries;~        -  Encourage and facilitate sharing of BCSC research resources, and continue developing and~          implementing our communications plan to expand resource dissemination;~        -  Provide statistical and scientific expertise to researchers, distribute customized~          limited datasets, and analyze BCSC data;~        -  Develop and support a new web-based dynamic query tool and other electronic interfaces~          to efficiently share aggregated BCSC data with the public.~   "
132594|NCT01831765|"~     This trial is conducted in Europe and the United States of America (USA). The aim of the~     trial is to investigate efficacy and safety of FIAsp (faster-acting insulin aspart) compared~     to insulin aspart, both in combination with insulin detemir in adults with type 1 diabetes.~     This trial consists of two periods: a 26 week treatment period followed by a 26 week~     additional treatment period.~   "
132595|NCT01831752|"~     This study is for adults and adolescents with type 1 diabetes. The purpose of this study is~     to learn more about an investigational system to measure blood glucose. This system does not~     require blood to be drawn from the body, and it does not require a glucose sensor to be worn~     under the skin (subcutaneously). This device instead estimates blood glucose levels by~     shining infrared light on the skin and then using sophisticated statistical analysis on how~     the light bounces back or gets absorbed (spectral data). The researchers in this study will~     compare the accuracy of the new device to glucose measurement devices that are already~     approved by the FDA, including glucose meters and subcutaneous continuous glucose monitoring~     (CGM) sensors. Information learned from this study will be used in the development of tools~     for managing diabetes.~   "
132596|NCT01831739|"~     This project is designed to address the following hypothesis:~      Distinct patterns in lung microbiome are characteristic of sarcoidosis phenotypes and~     reflected in changes in systemic inflammatory responses as measured by peripheral changes in~     gene transcription.~      The Specific Aims are:~        1. To identify peripheral blood mononuclear cell (PBMC) gene expression patterns that~          characterize distinct sarcoidosis phenotypes.~        2. To determine whether patterns in the lung microbiome are associated with sarcoidosis~          severity and disease phenotypes~        3. To correlate mRNA and microRNA expression patterns in sarcoidosis affected organs with~          changes in microbiome, clinical parameters and PBMC gene expression patterns~        4. To integrate clinical, transcriptomic, and microbiome data to identify novel molecular~          phenotypes in sarcoidosis.~   "
132597|NCT01831726|"~     The purpose of this signal seeking study was to determine whether treatment with dovitinib~     (TKI258) demonstrated sufficient efficacy in select pathway-activated solid tumors and/or~     hematologic malignancies to warrant further study.~   "
132598|NCT01831713|"~     Historically, transthoracic Doppler echocardiography has been unable to provide interpretable~     data of blood flow within the lung parenchyma because of air attenuation of Doppler signals.~     Recently, a transthoracic Doppler system known as the Sonara/tek Transcranial Doppler (TCD)~     System has been developed that can identify parenchymal pulmonary blood flow (PPBF) signals.~     The ability to non-invasively collect information regarding the pulmonary aspect of the~     cardio-pulmonary system may provide valuable information and new insights into the structural~     and functional characteristics of the lung parenchyma and vasculature in health and disease~     states.~   "
132599|NCT01831700|"~     This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single~     dose, cross over pivotal study. The purpose of this study is to assess the bioequivalence~     between Test Product and the corresponding Reference Product under fasting condition in~     normal, healthy, adult, human subjects.~   "
132600|NCT01831687|"~     This is a open Label, balanced, randomized, single dose, two-treatment, two-sequence,~     two-period, crossover, oral pivotal bioequivalence study. The purpose of this study is to~     assess the bioequivalence between Test Product and the corresponding Reference Product under~     fed condition in healthy, adult human subjects.~   "
132601|NCT01831674|"~     The study was a randomized, open label, two-treatment, two-period, two-sequence, single dose,~     crossover, oral bioequivalence study in normal, healthy adult human subjects under fed~     condition.~   "
132602|NCT01831661|"~     The study was a randomized, open label, two-treatment, two-period, two-sequence, single dose,~     crossover, oral bioequivalence study in normal, healthy adult human subjects under fasting~     condition.~   "
132625|NCT01831362|"~     This study addresses NCCAM's request for research that investigates the neuropsychological~     mechanisms underlying mind-body therapies, and for precise criteria and better delineation of~     meditation practices.~      The purpose of this study is to assess the clinical efficacy and mechanism of action of 2~     component practices of mindfulness meditation, i.e. focused awareness (FA) and open~     monitoring (OM) in comparison to each other and to the standard package, Mindfulness-Based~     Cognitive Therapy (MBCT).~   "
132626|NCT01831336|"~     This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring~     coronary revascularization with Drug Eluting Stents (DES).~   "
132603|NCT01831648|"~     Various assays can be used for IGF-I measurement in French laboratories. Unfortunately, each~     assay gives a very different result for the same sample. As IGF-I also varies with age, it is~     necessary to establish a broad population reference values of IGF1 concentration for each of~     the IGF1 assays used in clinical practice, taking into account individual variation factors~     such as age, nutritional status and possible treatments.~      The objective of this study is to establish normative data based on a large random selection~     from the general population, including representation from all age groups (around 100~     subjects for each decade age range). This will be performed for all the available assay kits.~     Subjects with medical conditions and medications that may affect the outcome will be~     excluded. Normative data will include the range (2.5 to 97.5 percentiles) in mass units and~     results will be reported as mass units but also as SD scores in order to be able, in a given~     patient, to compare its IGF-I concentration along time, even if using different assays.~   "
132604|NCT01831635|"~     There is a paucity of data on the aetiology of myeloproliferative neoplasms (MPNs). The~     investigators conducted a systematic review of the literature which identified several cohort~     and case-control studies that have investigated a wide range of potential medical,~     environmental and occupational risk factors. However, these studies have been limited by a~     wide variation in case definition and small sample sizes limiting the potential to detect~     modest risk differences between cases and controls. The research group propose an exploratory~     case-control study of 100 patients with classic MPNs and 200 controls to determine the~     optimal methods for roll out of this study to a multi-centred UK-based case-control study~     that will investigate the aetiology of MPN subtypes. The objectives of the study are to~     evaluate recruitment procedures, response rates, the development of a telephone administered~     questionnaire, compare occupational exposure assessment using OccIDEAS, a novel web based~     program, with a job-exposure matrix (FINJEM), evaluate the feasibility of collection of DNA~     from saliva compared to blood samples, identify potential aetiologic factors associated with~     MPNs and explore assessment of quality of life. The findings of this exploratory study will~     form the basis of a protocol for a large United Kingdom (UK)-wide case-control study of MPNs.~   "
132605|NCT01831622|"~     The goal of this trial is to investigate the cognitive- and brain-mechanisms underlying~     decision making (DM) and learning in young adults with Attention-Deficit/Hyperactivity~     Disorder (ADHD) as well as the modulation of task-related and task-independent brain~     activation by methylphenidate. The study aims at using a double-blinded, placebo controlled,~     cross-over, withdrawal design to study the effects of ADHD and methylphenidate in both a~     behavioural study investigating cognitive effects on decision making and instrumental~     learning, and a functional MRI (fMRI) study investigating the effects on brain mechanisms~     during decision making alone. A secondary objective of the trial is to measure the effect of~     adult ADHD and methylphenidate on cerebral perfusion. This will be done through applying a~     novel arterial spin labelling MRI-technique on the participants in the fMRI arm of the study.~   "
132606|NCT01831609|"~     To prospectively collect ascites, pleural fluid, circulating tumor cells and derived primary~     cultures from metastatic cancer patients. The specimens will be analyzed using~     DNA/RNA/proteomic approaches.~   "
132607|NCT01831596|"~     The purpose of this study is to evaluate the safety and efficacy of the Closed-Incision SNaP~     Device.~   "
132608|NCT01831583|"~     The goal of this study is to collect raw waveform data for two separate noninvasive methods,~     both of which may be useful for the assessment of upper airway obstruction.~   "
132609|NCT01831570|"~     Introduction Osteoarthritis is a chronic disease characterized by a progressive degradation~     of articular cartilage. Hand OA involves symptomatically more than 1 million of subjects in~     France (i.e., painful or with functional impairment). To date, the treatment of OA is only~     symptomatic and no drugs are able to stop the degradative process of cartilage.~      50% of patients with hand OA exhibit a functional impairment responsible for a severe~     handicap, which is almost similar to rheumatoid arthritis. While the risk factors of hand OA~     are well identified (i.e., familial history, female sex, menopause, obesity), clinical~     outcome in large cohort is poorly known. In addition, the investigators miss predictive~     clinical, biological or imaging factors of severe clinical (i.e. pain, functional impairment~     or aesthetic damage) or structural evolution (i.e., aggravation of radiographic scores).~      Primary objective To investigate in hand OA patients predictive clinical, biological, genetic~     and imaging factors of clinical aggravation after 6 years of follow-up.~      Secondary objectives To investigate in hand OA patients predictive clinical, biological,~     genetic and imaging factors of clinical aggravation after 3 years of follow-up.~      To investigate in hand OA patients predictive clinical, biological, genetic and imaging~     factors of clinical aggravation after 3 years of follow-up.~      To investigate whether variations of clinical evaluation of hand hand OA and radiographic~     structural changes are associated or correlated between inclusion and 3 years of follow-up or~     between inclusion and 6 years follow-up To investigate whether clinical status and~     radiographic alterations are correlated at inclusion To determine whether hand OA is~     associated with OA at other sites or with other hand diseases (carpal tunnel syndrome,~     tendinitis) To evaluate frequency of erosive hand OA among the whole hand OA cohort at~     inclusion, at 3 and 6 years of follow-up To identify clinical, biological, genetic and~     imaging factors associated with erosive hand OA (versus non erosive hand OA) at inclusion or~     during the follow up (3 and 6 years) To investigate predictive clinical, biological, genetic~     and imaging factors of clinical or radiographic aggravation after 3 or 6 years of follow-up~     in the erosive hand OA subgroup~      Methods :~      the investigators plan to include 500 patients in the cohort (5/week) 7 visits (one per year)~     are planned: M0, M12, M24, M36, M48, M60 and M72. A clinical evaluation of hand OA will be~     performed at each visit. At visit M0, M36 and M72, hand radiographs and radiographs of other~     OA localisation (if symptomatic) will be performed.~      A blood sample will be taken at inclusion for biomarker studies and genetic investigations.~      A blood sample will be taken at M36 and M72 to build a prospective serum collection.~      Duration of the study: 8.5 years with 2.5 years of inclusion period Duration of the study for~     one patient: 6 years Recruitment at the Rheumatology Department of Saint-Antoine Hospital~     with a multicentric international steering committee~      Potential outcomes :~        -  Identification of clinical, radiological and biological tools useful to predict clinical~          and structural outcomes~        -  Description of the history course of hand OA and predictive factors of severe evolution~          (i.e. erosive form of hand OA) To integrate in daily practice, clinical and radiological~          tools allowing a standardized follow up of hand OA patients.~   "
132610|NCT01831557|"~     The objective of this study is to explore the genetic basis of the influence of dairy product~     intake on body measures in children. The investigators assume that the effect of dairy~     products intake on children body measures is affected by genetic polymorphisms.~   "
132611|NCT01831544|"~     This multi-center, prospective, non-randomized, single-arm trial will investigate the safety~     and performance of the HeartWare® Miniaturized Ventricular Assist Device (MVAD®) system over~     24 months in subjects with advanced heart failure~   "
132612|NCT01831531|"~     This trial aims to study the safety, the local control, and the overall survival of S-1~     combined with radiotherapy for patients with esophageal squamous cell carcinoma. 105 patients~     will be recruited into this trial.~   "
132627|NCT01831323|"~     To evaluate the effect of the probiotic formulation VSL#3 on the metabolome and microbiota of~     diverticular disease, comparing it with the effects exerted by supplementation with fibers,~     by rifaximin and by mesalazine, and assessing the evolution over time after each specific~     treatment~   "
132674|NCT01830712|"~     This study is conducted in the United States of America (USA). The aim of this study is to~     assess the long-term (5+ years) postoperative functional outcomes of elective orthopaedic~     surgery (EOS) patients from previously reported studies F7HAEM/USA/3/USA and F7HAEM/USA/4/USA~     (NCT01561391) and furthermore to assess the impact of EOS on psychosocial outcomes, frequency~     of bleeding episodes and durability of joint surgery.~   "
132613|NCT01831518|"~     Cardiac resynchronization therapy (CRT) involves pacing the left and right side of the heart~     in order to improve the coordination of the contraction in patients with heart failure.~     Current selection criteria incorporate the severity of the symptoms, the mechanical function~     of the heart and the time it takes the electrical stimulation to spread over the left~     ventricle (as assessed on the standard 12 lead electrocardiogram-ECG). Unfortunately these~     criteria only seem to select approximately 70% of the patients who might respond to this~     invasive therapy. Body surface ECG mapping is a new technique that assesses the electrical~     activation of the heart in more detail than the standard ECG. This study aims to determine~     whether this new technology may aid current selection criteria in predicting response to CRT.~   "
132614|NCT01831505|"~     Many cancer patients are prescribed drugs to which their cancer is already resistant - and~     thus suffer toxicity with no potential for benefit. Previous attempts to assess~     chemoresistance or sensitivity in vitro have failed. This is a feasibility study in human~     patients with newly diagnosed or recurrent lymphoma to determine how human cancerous lymph~     nodes in situ respond to standard of care therapeutics precisely microinjected with the~     CIVO(tm) microdosing system.~   "
132615|NCT01831492|"~     Purpose:~      This study investigates the effects of dietary zeolite + dolomite on performance,~     exercise-induced acidosis, oxidative stress, inflammation and intestinal barrier dysfunction~     in trained people.~      Hypotheses (H1):~      Zeolite + dolomite increase performance in an ergometer step test Zeolite + dolomite reduce~     exercise-induced acidosis Zeolite + dolomite reduce oxidative stress Zeolite + dolomite~     reduce inflammation Zeolite + dolomite improve intestinal barrier dysfunction~   "
132616|NCT01831479|"~     This study investigates pharmacokinetics and drug-drug interaction between Rosuvastatin and~     Olmesartan in healthy male volunteers~   "
132617|NCT01831466|"~     The study is beng done to test if tofacitinib ointment is safe and effective for people with~     plaque psoriasis. Two dose strengths of tofacitinib ointment (20 mg/g and 10 mg/g) applied~     once or twice daily are being tested. The safety and effectiveness of tofacitinib ointment~     used for 12 weeks will be compared to the safety and effectiveness of placebo ointment~     (vehicle) used for 12 weeks.~   "
132618|NCT01831453|"~     The study aims at evaluating the effect of omega-3 on patients suffering recurrent oral~     aphthous ulcers~   "
132619|NCT01831440|"~     The purpose of this study is to determine the level of residual symptoms and psychosocial~     factors affecting recovery of psychosocial functions in MDD patients who reach remission, and~     investigate the recovery process of psychosocial functions.~      The investigators suppose that even the patient is well-treated by drug,there are still many~     residual symptoms,and they also exist different degree of damage in the structure and~     functions of brain. CBT could help them obtain better recovery,especially in psychosocial~     functions.~   "
132620|NCT01831427|"~     This is a staggered, placebo-controlled, single and multiple ascending dose (SAD/MAD) study~     evaluating the safety, tolerability and pharmacokinetics of GS-5745 in participants with~     moderately to severely active ulcerative colitis. This study will provide valuable data that~     can help establish the safety, pharmacokinetics and efficacy of GS-5745 in participants with~     ulcerative colitis.~   "
132621|NCT01831414|"~     Balneotherapy is a physiotherapy technique which allows patients to work out in a weightless~     environment and which is often used in patients with spinal cord injury. In normal subjects,~     water immersion generates a reduction in lung volumes. The effects of water immersion on the~     respiratory function of spinal cord injury patient (who are liable to present a respiratory~     failure secondary to paralysis) are not well known. They could be deleterious (by majoring~     respiratory failure)or beneficial (by mimicking the effect of a corset and improving~     respiratory function). Therefore, we are planning to study the effect of different water~     immersion levels on the respiratory function of spinal cord injury patients.~   "
132622|NCT01831401|"~     Total Hip Arthroplasty (THA) is one of the most commonly performed orthopaedic operations~     worldwide. The main aim is overall improvement in levels of patient pain and mobility. Such~     surgery involves implantation of both an acetabular and femoral component. With the patient~     in the lateral decubitus position, the Orthopaedic Surgeon assumes that the pelvis is in a~     neutral position with respect to all three body planes at the time of acetabular component~     implantation.~      With regard to THA, the current orthopaedic literature demonstrates a clear relationship~     between acetabular component positioning, polyethylene wear and risk of dislocation. Problems~     with edge loading, stripe wear and squeaking are also associated with higher acetabular~     inclination angles, particularly in hard-on-hard bearing implants.~      The important parameters of acetabular component positioning are depth, height, version and~     inclination.~      Control of acetabular component inclination, particularly in the lateral decubitus position,~     is difficult and remains a challenge for the Orthopaedic Surgeon.~      Accurate implantation of the acetabular component within the 'safe zone' of radiological~     inclination is dependent on:~        -  Operative version~        -  Operative inclination~        -  Pelvic position (Primarily, but not exclusively, abduction / adduction.)~      This study aims to investigate the effect of patient pelvic positioning and method of~     acetabular component insertion on acetabular component inclination during Total Hip~     Arthroplasty (THA).~   "
132623|NCT01831388|"~     The purpose of this study is to test whether a breath training exercise program may be used~     to make patients with chronic lung conditions feel less short of breath, whether such a~     program is well received by patients and whether a future larger study is worthwhile.~      The breath training exercise program uses some breathing techniques derived from Yoga~     practices. They were shown to help patients experiencing shortness of breath feel less short~     of breath in other settings. Whether the training is beneficial to patients with chronic lung~     conditions, especially those with a history of cancer affecting their lungs, is not clear.~     This study would help us answer that question.~   "
132624|NCT01831375|"~     This research represents a pioneering effort to design a brief, cost effective and readily~     transportable program that will enable disadvantaged elders to become more effective~     participants in their health care.~      The intervention is expected to result in trained elders becoming more knowledgeable health~     care partners. Trained patients will be prepared for appointments and will engage their~     primary care physicians in active dialogue regarding cancer prevention and screening.~      Based on self-advocacy, these patients are expected to receive better preventive care and~     report greater satisfaction with care. Program participation can subsequently contribute to~     general health improvements and minimize health disparities.~   "
132628|NCT01831310|"~     Hypercatabolism and immune suppression are frequently seen in patients with malignancy.~     Preoperative nutritional state is an important factor in determining surgical and~     postoperative complications because the preoperative nutritional status affects the~     postoperative nutritional state, immunity and inflammatory response. In these patients,~     standard parenteral nutrition may not be sufficient to maintain the immunity and provide~     positive or stabilized nitrogen balance. Preoperative and perioperative supplementation with~     immune-enhancing enteral nutrition has been reported to increase total lymphocytes and T~     lymphocytes and decrease circulating levels of interleukin 6 and tumor necrosis factor- alfa.~     There is a report which showed that glutamine dipeptide supplemented parenteral nutrition~     improved the cellular and humoral immune functions. The investigators aimed to evaluate the~     effect of postoperative glutamine-dipeptide and/or omega 3 fatty acid supplemented parenteral~     nutrition on the neutrophil functions and postoperative course of patients with colorectal~     cancer.~   "
132629|NCT01831297|"~     This study´s aim is to explore physiological associations concerning pulse wave velocity,~     heart rate and blood pressure in order to make taking the blood pressure more comfortable.~   "
132630|NCT01831284|"~     The goal of this study is to learn how injection drug use may affect the immune system.~   "
132631|NCT01831271|"~     The overall objective is to evaluate if treatment with a neck-specific exercise program and~     cognitive behavioural approach improves the outcome compared with prescribed, self-mediated~     and progressive physical activity in patients with cervical radiculopathy. There is a lack of~     evidence of the best treatment for the patient category. Many patients are sick-listed for~     long periods of time with different kind of treatment approaches or without any treatment at~     all. The present study could fill the identified knowledge gap by strengthening of the~     currently weak scientific evidence for treatment of the patient category. The long-term~     effects of the study could be to reduce the time for sick leave and improve the rate of~     patients returning to work and/ or former activity by optimising treatments. Further on, to~     decrease the number of patients who finally have surgery for their neck problems and thus~     reducing the mental, physical and social costs.~   "
132632|NCT01831258|"~     Conceptually, awareness of pressure occurs only during wakefulness. Thus reducing the~     pressure during wakefulness may improve therapy comfort and potentially adherence without~     compromizing therapy efficacy. SensAwake™ is a unique pressure relief technology developed by~     Fisher & Paykel Healthcare which detects irregularity in the flow signal indicative of the~     transition from sleep to wake. When the transition from sleep to wake is detected the device~     promptly reduces the pressure to help facilitate a return to sleep.~      The purpose of this study is to compare adherence and sleep quality outcomes in patients~     treated by CPAP with and without SensAwake technology.~      It is hypothesised that participants with SensAwake on will have improved adherence and sleep~     quality.~   "
132633|NCT01831245|"~     Register study. Patients who had been operated for right-sided colon tumor or benign adenoids~     between year 2011 to 2012. The study compare open surgery with laparoscopic surgery in an~     ERAS (Enhanced Recovery After Surgery) protocol.~      Hypothesis:~      Operation of right-sided colon tumor and large benign adenoids, a better selection of~     patients for open or laparoscopic surgery can improve short term results.~   "
132634|NCT01831232|"~     This clinical trial studies idarubicin, cytarabine, and pravastatin sodium in treating~     patients with newly diagnosed acute myeloid leukemia or myelodysplastic syndromes. Drugs used~     in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop the growth~     of cancer cells, either by killing the cells or by stopping them from dividing. Pravastatin~     sodium may stop the growth of cancer cells by blocking some of the enzymes needed for cell~     growth. Giving idarubicin and cytarabine together with pravastatin sodium may kill more~     cancer cells.~   "
132635|NCT01831219|"~     This is a follow-up study looking at the and long-term results of two methods of preparing~     the thigh bone to receive an implant during hip replacement surgery. For one group of~     patients in the original study, the surgeon used a cutting tool called a broach and a special~     hammer on patients who had standard hip replacement operations. For the other patients, the~     surgeon used a surgical robot which was equipped with a cutting tool, like a drill, to~     prepare the thigh bone. The purpose of this study is to collect additional information~     confirming that the surgical robot is safe and effective when used as recommended. Only~     patients who were enrolled in the original clinical trials are eligible for this study.~   "
132636|NCT01831206|"~     The purpose of this study is to evaluate the efficacy of collagen cross-linking for treatment~     of infectious keratitis.~   "
132637|NCT01831193|"~     The purpose of this study is to determine if the oral supplementation with curcumin reduces~     proteinuria in patients with chronic kidney disease regardless the ethiology.~   "
132638|NCT01831180|"~     The purpose of this study is to compare the differences in various chemical and biologic~     parameters of scalp and and hair parameters between young and old Caucasian females. The hair~     state and scalp blood flow in younger and older age groups with typical hair care practices~     will be qualified by measuring various parameters of the hair shaft and scalp with~     correlation back to hair and scalp satisfaction as measured in the subject. This is a single~     center study with an anticipated 4 month enrollment period. The investigators will compare~     various scalp and hair parameters between young and old Caucasian females by obtaining the~     following biological and chemical/structural information. Hair growth rate, anagen to telogen~     ratio, hair density (determined via phototrichogram and digital imaging), Vascular blood flow~     (Laser Doppler Flowmetry), Histamine stimulation and Hair diameter (clipped hairs). In~     addition, a detailed questionnaire will be administered to each subject regarding~     satisfaction of the subject's hair state, including typical hair care regimens and symptoms~     in scalp and/or hair shafts. This information will be correlated to the biologic and~     chemical/structural information about hair and scalp health. Approximately 50 healthy,~     Caucasian female subjects will be enrolled in this study. Twenty five participants will be~     19-25 years-old and 25 participants 60 years or older. There will be two visits, Baseline and~     approximately 48 hours after baseline.~   "
132639|NCT01831167|"~     In two sessions of four days nurses will be exposed to dynamic lighting and normal~     (reference) lighting. Through the psychological tests T.O.D.A. (Test or divided attention)~     and T.O.S.S.A. (Test of sustained selective attention), then the focus tested. These two~     tests run both 5 times. The investigators also ask to fill out: 3 questionnaires, fatigue and~     mood, sleep and Questions of Life.~   "
132640|NCT01831154|"~     The purpose of this study was to investigate the effects of three different glycemic~     treatment conditions (tight, conventional, and standard) in the intraoperative period on: 1)~     postoperative surgical site infections, and 2) postoperative procalcitonin, and C-reactive~     protein levels in patients undergoing open-heart surgery. Secondary aims of the study were to~     investigate the effects of the three glycemic treatment conditions on: 1) intraoperative~     blood glucose; 2) intraoperative glycemic stability; and 3) intensive care unit length of~     stay, in patients undergoing open-heart surgery.~   "
132641|NCT01831141|"~     Congenital solitary kidney (CSK) is a disorder caused by an abnormal development of one of~     the two kidneys. The reported incidence ranges between 1:450-3200. It is debated whether CSK~     is a benign condition or not. A variable risk of developing proteinuria (11-27%),~     hypertension (0-60%) and chronic kidney damage (3.5-30%) is described. This knowledge derives~     mainly from retrospective studies performed in tertiary medical centers which is difficult to~     compare for the following reasons: the number of individuals evaluated, the length of~     follow-up and the outcome studied.~      The aim of this longitudinal study is to assess, in a cohort of children with congenital~     solitary kidney, during a 10 year follow-up period: 1) the rates of developing proteinuria,~     hypertension and chronic kidney disease and the corresponding potential prognostic factors.~     2) the role of new biomarkers of glomerular (Cystatin C) or tubular damage (NGAL, NAG,~     B2-microglobulin) in predicting the appearance of chronic kidney damage.~   "
132642|NCT01831128|"~     The purpose of FACE study is to provide in routine practice complementary long-term data on~     the mortality and morbidity of Chronic Heart Failure (CHF) patients with Central Sleep Apnea~     eligible for Adaptative Servo-Ventilation (ASV) treatment (PaceWave, AutoSet CS; ResMed).~   "
132643|NCT01831115|"~     To improve the diagnostic and prognostic utility of various biomarkers, detailed patient's~     history, physical examinations and technical devices in patients presenting with acute~     dyspnea.~   "
132644|NCT01831102|"~     The purpose of this protocol is to measure and compare levels of the circulating protein~     adiponectin and adiponectin's association with insulin sensitivity in Mexican Americans and~     non-Latino white subjects. The investigators also aimed to examine associations between~     nutritional factors and adiponectin levels.~   "
132645|NCT01831089|"~     Clinical trial of PM01183 in combination with paclitaxel, with or without bevacizumab, in~     patients with solid tumors~   "
132646|NCT01831076|"~     This phase II trial studies how well exemestane before surgery works in treating~     postmenopausal patients with newly diagnosed estrogen receptor positive stage II-III breast~     cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using~     exemestane may fight breast cancer by blocking the use of estrogen by the tumor cells.~   "
132647|NCT01831063|"~     Caregivers of children with seizures receiving simulation based seizure management teaching~     in addition to the traditional seizure teaching will report more confidence with seizure~     management and demonstrate a higher level of performance with seizure management.~   "
132648|NCT01831050|"~     This study is a Phase IV, open, randomized, multi-center, controlled vaccine trial conducted~     in healthy Latin American infants, utilizing one or two supplemental doses of IPV in children~     previously vaccinated with 3 doses of bOPV. We will examine the impact of supplemental IPV on~     stool shedding and humoral immunity, as well as intra-IPV manufacturer comparability, and~     safety.~   "
132649|NCT01831037|"~     This study aims to demonstrate that patients with chronic hepatitis C (CHC) and B (CHB)~     experiencing regression of liver cirrhosis after effective antiviral therapy have decreased~     risk for hepatocellular carcinoma (HCC). Primary aim is to determine the incidence of HCC in~     patients with cirrhosis secondary to CHC and CHB, after treatment is provided, and to~     identify the magnitude of the decreased risk for HCC in patients experiencing regression of~     fibrosis. As a secondary aim, environmental risk factors for HCC development will be sought,~     in order to determine a subset of patients in whom it will be safe to stop surveillance.~   "
132650|NCT01831024|"~     The efficacy and safety of the Dignicap System to prevent chemotherapy induced alopecia will~     be evaluated in women with early breast cancer undergoing adjuvant or neoadjuvant~     chemotherapy regimens. The scalp cold cap will be applied at each chemotherapy cycle. Hair~     loss will be evaluated by patient self assessment of 5 standardized photographs taken prior~     to each chemotherapy cycle. A concurrent control group not using a cold cap will also be~     evaluated.~   "
132651|NCT01831011|"~     Mildronate an inhibitor of carnitine-dependent metabolism, is considered an anti-ischemic~     drug. This study aims to evaluate the efficacy and safety of mildronate injection in treating~     acute ischemic stroke.~   "
132652|NCT01830998|"~     The rate of cognitive decline due to ageing is increased 1.5-fold to 2.0-fold in individuals~     with type 2 diabetes.There are no established specific treatment measures to prevent or~     ameliorate cognitive impairments in patients with diabetes. we want to detecte early clinical~     dementia in diabete.~   "
132653|NCT01830985|"~     This study is designed to evaluate the long-term safety and tolerability of VX-509 in~     subjects with active rheumatoid arthritis (RA) on DMARD therapy. This study will enroll~     subjects who completed a previous designated study with VX-509 (e.g., Study VX12-509-103).~   "
132654|NCT01830972|"~     The safety objectives of the study are to: evaluate additional long-term safety of SA-ER~     treatment of participants with GNE myopathy previously treated with SA-ER at dose of 6g/day~     (Part I); evaluate the safety of 12g /day SA (delivered by 1.5g of SA-ER tablets and 1.5g of~     SA-IR capsules 4 times per day) in the treatment of participants with GNE myopathy (Part II)~     over a 6 month treatment period; evaluate the safety of SA treatment at both 6g/day and 12~     g/day (Part III [SA-ER/SA-IR] and Part IV [SA-ER]).~   "
132655|NCT01830959|"~     Pulmonary sarcoidosis patients with fibrosis often develop recurrent episodes of bronchitis.~     These can lead to worsening of disease for both the short and long term.~      Roflumilast has been shown to reduce the number of acute bronchitis episodes in patients with~     COPD.~      Drugs similar to Roflumilast have been shown to help sarcoidosis. The current study is to~     determine if Roflumilast will reduce number of episodes of bronchitis and help fibrotic~     sarcoidosis.~   "
132723|NCT01830062|"~     The aim of this study is to compare the relationship between the coronary artery~     calcification assessed by MDCT with the plaque characteristics and necrotic lipid core~     content of non-intervened coronary segments assessed with near infrared spectroscopy (NIRS)~     in patients with symptomatic coronary artery disease (CAD).~   "
132656|NCT01830946|"~     Obesity is recognized as a major public health concern because of its link to potential fatal~     complications arising from metabolic and cardiovascular diseases. Despite many~     pharmacological advances in this field, lifestyle strategies that emphasize proper nutrient~     intake and physical activity continue to be the primary strategy for individuals to fight~     obesity. However, controversy exists regarding the type and timing of exercise and specific~     nutrient intake to maximize fat loss, muscle gain, and beneficial cardio-metabolic~     adaptations derived from these lifestyle interventions. Furthermore, limited data exists~     investigating the impact of nutrient timing at times other than immediately before or after~     exercise and no studies have examined time-of-day nutritional intake in overweight or obese~     individuals.In addition, many individuals attempting to improve body composition and~     cardio-metabolic health are concerned with what food choices are appropriate in the late~     evening to support positive physiological adaptations. However, research-based information~     examining this topic is scarce.~      The investigators hypothesize that consumption of a protein beverage in the late evening~     before sleep will improve body composition, cardio-metabolic health, and adaptations to~     exercise more than an isocaloric placebo beverage. The investigators also hypothesize that~     the different digestion and absorption kinetics of whey and casein proteins will elicit~     different effects on the measures variables.~   "
132657|NCT01830933|"~     The proposed research combines the scientific advances in breast cancer research with health~     information technology (IT) to design a personalized intervention that assesses breast cancer~     risk for women, disseminates important breast health information, and facilitates discussion~     of breast cancer risk reduction practices. Our goal is to implement a tablet-PC (personal~     computer) based breast cancer risk education (BreastCare) intervention in the primary care~     setting that estimates a woman's individual risk for breast cancer and provides her and her~     physician with personalized breast cancer risk information and recommendations for action.~   "
132658|NCT01830920|"~     The purpose of this study is to determine whether THR-184 when administered around the time~     of cardiac surgery that requires cardiopulmonary bypass can prevent or ameliorate the~     development of acute kidney injury.~   "
132659|NCT01830907|"~     Evaluation of the impact of preoperative nutritional support on clinical outcomes in patients~     at nutritional risk. The primary endpoint was the complication rate and the second endpoint~     was the length of stay.~   "
132660|NCT01830894|"~     MRI research Group in the Advanced Technology Center of the Sheba Medical Center has~     developed an innovative methodology based on leakage (extravasation) contrast agent that~     allows to map the entire brain with high resolution and high sensitivity to check and~     describe disorders BBB (blood brain barrier).~      The aim of the current study is to evaluate the feasibility of the BBB disruption detection~     method to predict delayed peri - hemorrhage edema.~   "
132661|NCT01830881|"~     The purpose of this study is to determine the level of pain, anxiety and side effects that~     women experience with a surgical abortion and the effect that the anti-anxiety medication,~     midazolam, might have when used along with ibuprofen and a paracervical block (PCB) instead~     of the standard pain treatment of only ibuprofen and a PCB.~   "
132662|NCT01830868|"~     This is a Non-interventional Prospective Study. Centres will enroll adult patients with~     partial onset seizures for whom the clinician has decided to initiate ZNS as an adjunctive~     therapy prior to the decision to take part in this study. Patients to be enrolled into the~     study are not sufficiently controlled with one dug licensed for the use of monotherapy in~     partial onset seizures. Patients will be seen at baseline and then during normal clinical~     visits at intervals which are appropriate to the typical practice of the treating clinician.~     Patients will be assessed at baseline and then at least 3 and 6 months after the baseline.~   "
132663|NCT01830855|"~     This study is looking at a new vaccine that might prevent meningococcal disease, and will~     study whether healthy adolescent subjects receiving different lots of vaccine respond in a~     similar way. The study will also look at the safety of the new vaccine as well as how it is~     tolerated.~   "
132664|NCT01830842|"~     The purpose of this study is to use functional magnetic resonance imaging (fMRI) to~     investigate the acute and chronic effects of nicotine on motivational behavior and prediction~     error-related neural activation. Nonsmokers (n = 24) and smokers (n = 24) will undergo fMRI~     scans on two separate occasions while performing a decision-making task that will elicit~     prediction error signals in the mesocorticolimbic pathway of the brain. Nonsmokers will be~     scanned once following an acute dose of nicotine and once following placebo administration.~     Smokers will be scanned once following smoking as usual and once following 24-hours of~     smoking abstinence, in order to measure the effects of nicotine withdrawal. The study team~     hypothesizes that acute nicotine will increase the prediction error signal in nonsmokers~     compared to placebo, and that nicotine withdrawal will decrease the prediction error signal~     in smokers compared to the normal satiated condition. Furthermore, nonsmokers (during the~     placebo condition) will have greater prediction error activation than smokers (during the~     satiated condition). The results of this study will inform whether the initiation and~     maintenance of smoking behavior could be facilitated by the effects of nicotine on~     reinforcement learning.~   "
132671|NCT01830751|"~     The purpose of the proposed study is to test the effect of an intervention technique that~     reduces trunk flexion upon rising, on the outcome measures of self-reported back pain and~     functional impairment in individuals with chronic or recurrent non-specific low back pain~     (LBP). The intervention is a self-administered and requires no medical intervention or drugs.~     The technique referred to as the restrained sitting treatment (RST), involves training in~     minimizing forward bending of the trunk immediately upon rising. The technique builds upon a~     previous randomized controlled study conducted and published by members of the research team.~     The underlying premise of RST exploits the natural diurnal pattern as the intervertebral~     discs (people are tallest when they first wake up). The discs are fully hydrated upon rising,~     disc internal hydrostatic pressures and external forces acting on surrounding soft tissues~     are greatest at this time, and these pressures and forces can increase significantly with~     trunk flexion. The RST technique utilizes a back support used in sitting during the first~     hour upon rising to minimize trunk flexion during this critical period as the intervertebral~     discs begins the diurnal cycle of fluid loss. The study will test the null hypothesis that~     there are no significant difference in outcome (LBP, work or social function/disability)~     between groups performing RST, the experimental group performing RST upon rising, the control~     group performing prior to going to bed.~   "
132665|NCT01830829|"~     Benign Prostatic Hyperplasia (BPH) describes a common medical condition in men over 45~     associated with voiding (obstructive) and storage (irritative) lower urinary tract symptoms~     and is in part related to prostate enlargement and obstruction. The standard medical therapy~     for this condition includes 5-alpha reductase inhibitors -5ARI (eg dutasteride) or alpha~     blocker therapy (eg tamsulosin), while the most effective medical therapy for BPH is the~     combination of these two medications. Approximately 10 to 20% of patients diagnosed with BPH~     also have either a diagnosis of or symptoms of chronic prostatitis/chronic pelvic pain~     syndrome (CP/CPPS) with typical genito-urinary pain and discomfort. This particular subset of~     patients of BPH patients with prostatitis symptoms pose a therapeutic dilemma. CP/CPPS (organ~     specific phenotype) is the third most prevalent prostate disease after prostate cancer and~     BPH. CP/CPPS is very prevalent (3-9% of men) and represents a significant percentage of~     urology outpatients (3-8% of male outpatient visits)resulting in a major impact on quality of~     life of patients and economic costs to society. Clinical phenotyping allows for prediction of~     the patients with CP/CPPS most likely to respond to dutasteride and tamsulosin (age, Lower~     Urinary Tract Symptoms [LUTS] and prostate related phenotypes [BPH]). It can be estimated~     that up to 30% of men currently diagnosed with CP/CPPS will include men with co-existing~     Benign Prostatic Hyperplasia (BPH) We propose to determine the efficacy of JALYN~     (dutasteride-tamsulosin combination) in the amelioration of prostatitis symptoms in men~     diagnosed with CP/CPPS who have the following clinical phenotype; age = 45 years, Lower~     Urinary Tract Symptoms (LUTS), enlarged prostate and Organ (prostate) specific symptoms (eg.~     BPH and CP/CPPS).~   "
132666|NCT01830816|"~     This is a phase 1/1b, open-label, multicenter study of oral ixazomib (MLN9708)designed to~     assess the pharmacokinetics (PK) of single dose ixazomib in patients with normal renal~     function and in patients with severe renal impairment (RI) (according to Cockcroft-Gault~     estimates). Twenty-eight PK-evaluable patients will be enrolled in either 1 of the 2 arms of~     the study.~      Arm 1: (N = 12): Normal renal function (creatinine clearance [CrCl] ≥ 90 mL/min)~      Arm 2: (N = 16): Severe RI (CrCl < 30 mL/min) including at least 6 patients with ESRD,~     defined as renal failure requiring hemodialysis~   "
132667|NCT01830803|"~     Quality of life and patient satisfaction are two important concepts in health care,~     especially in chronic diseases. Currently, there are several instruments available to~     determine this, but many are not easily applicable in daily practice because of their length~     and the consequential effort they require from both patients and caregivers.~      In the UK, Benson et al. recently developed two short generic patient questionnaires on~     quality of life and patient satisfaction: the howRu and howRwe questionnaires. Both~     questionnaires contain four items.~      The howRU questionnaire has already been validated and seems highly applicable to be used in~     large patient groups. The howRwe questionnaire has not been validated yet. The reliability of~     both questionnaires has not been assessed either. The procedure as suggested by Kocks et al.~     provides us with the opportunity to perform a reliability procedure on patient level.~      The purpose of this study is to assess the reliability of the howRU and the howRwe~     questionnaires on patient level in the Dutch population.~   "
132668|NCT01830790|"~     Choroidal thinning has been hypothesized to partake in the pathogenesis of age-related~     macular degeneration (AMD), but it is not known if increasing choroidal thickness may~     potentially alter the disease course. Past studies have shown that a single dose of the~     phosphodiesterase type-5 inhibitor sildenafil citrate can increase choroidal thickness in~     young healthy patients. The investigators hypothesize that sildenafil may also increase~     choroidal thickness in eyes with AMD and perhaps potentially reduce AMD progression.~     Alternatively, if sildenafil has minimal effect on choroidal thickness in eyes in patients~     with AMD, such results may suggest that choroidal vascular compliance or stiffness is reduced~     in this condition. Patients seen at the Duke Eye Center with a diagnosis of AMD or~     age-matched control subjects with no macular pathology will be administered a single 100mg~     oral dose of sildenafil citrate (Viagra®; Pfizer), and undergo EDI-OCT imaging before and~     after treatment. Images obtained will be used to measure choroidal thickness, as well as~     central macular thickness (CMT) and macular volume (MV). Choroidal thickness changes after a~     single-dose sildenafil treatment in AMD patients will be compared with age-matched control~     subjects using standard statistical methods. By also correlating choroidal thickness changes~     with functional (visual acuity) and anatomical (CMT & MV) changes, the investigators hope to~     further their understanding of the choroid's role in aging and AMD pathogenesis. The safety~     of a single dose of sildenafil citrate will be addressed by excluding any patients with risk~     factors or using medications that are contraindicated for sildenafil as determined by careful~     informed consent and a study questionnaire.~   "
132669|NCT01830777|"~     This research study is a Phase I clinical trial. Phase I trials test the safety of an~     investigational drug or combination of drugs. These trials also try to define the appropriate~     dose of the investigational drug to use for further studies. Investigational means that the~     combination of drugs is still being studied and that research doctors are trying to find out~     more about it. As part of this research study, patients will be administered brentuximab~     vedotin in combination with a conventional re-induction chemotherapy regimen called MEC,~     which consists of the chemotherapy drugs mitoxantrone, etoposide, and cytarabine. Brentuximab~     vedotin has not been approved by the FDA for the patient's cancer. However, brentuximab~     targets a protein on tumors called CD30, and it is approved for other cancers which express~     CD30, and these include Hodgkin lymphoma. This means that the FDA has not approved giving~     brentuximab in conjunction with MEC for use in people, including people with this type of~     malignancy, acute myeloid leukemia (AML).~      Mitoxantrone, etoposide and cytarabine are chemotherapy agents that are commonly used to~     treat individuals with relapsed AML. Brentuximab is an antibody-drug conjugate (ADC), which~     is the combination of an antibody (a protein that binds to cells) and a drug. Brentuximab~     vedotin works by using the antibody portion to enter into CD30-positive cells and then~     releasing the drug portion, which attempts to destroy the cell. Brentuximab vedotin has been~     used in laboratory and other research studies and information from those studies suggest that~     brentuximab vedotin may slow down the spread of cancers which express CD30. Some AML cell~     express CD30, so investigators hope that brentuximab vedotin will help with this type of AML.~      The primary purpose of this research study is to determine the highest dose that Brentuximab~     vedotin can safely be given with MEC without severe or unmanageable side effects. The dose~     identified in this study will be used in future research studies.~   "
132670|NCT01830764|"~     The purpose of this study is assess the safety and tolerability of lemuteporfin topical~     solution (LTS) with exposure to red light (PDT), when applied to the backs of healthy~     volunteers.~   "
132672|NCT01830738|"~     The main objective of the study is the comparison of the effective duration of~     hospitalization following laparoscopic hysterectomy via a single-port peri-umbilical~     technique versus an conventional multi-port technique.~   "
132673|NCT01830725|"~     Determine whether a relationship exists between polymorphisms of the genes XDH, HPRT1, and~     PRPS1 and gout, hyperuricemia, or the dose of xanthine oxidase (XO) inhibitors to reach a~     goal serum uric acid of less than 6 mg/dL. This study is observational in nature as no dose~     adjustment of XO inhibitors will be made by study investigators.~   "
132675|NCT01830699|"~     To date no trials have been performed looking at whether or not intra-bursal injection of an~     IL-1 antagonist provides pain relief similar to that of a corticosteroid injection. The~     subcutaneous injection of anakinra, an IL-1 receptor antagonist, in patients with shoulder~     pain due to rotator cuff tendonitis and subacromial bursitis was efficacious in relieving~     pain but this information was presented as a case series in a letter to the editor format, so~     the validity of these results would require additional testing [Omoigui S, et al. 2004].~     Based mainly on the data from the intra-articular administration of anakinra, there have not~     been any adverse trends in outcomes or safety to suggest that intra-bursal injection of~     rilonacept will carry an increase risk of adverse events. The purpose of this trial is to~     compare the improvement in pain and function of patients with clinical symptoms and signs of~     subacromial bursitis of rilonacept vs. corticosteroid injection (standard of care).~   "
132676|NCT01830686|"~     The purpose of this study is to help understand the benefits of eating food supplemented with~     fiber in the form of sugarcane bagasse (the leftover fiber after cane juice is extracted) on~     glucose metabolism and body weight.~   "
132677|NCT01830673|"~     The primary endpoint was the induction of T-regulatory cells under s specific subcutaneous~     immunotherapy (SCIT). Patients suffering from grass pollen allergy (relevant clinical~     symptomes during the pollen season, Skin Prick test diamter >4mm or RAST class II or higher)~     were included. The patients were allocated to three study groups:~      Group 1: during and directly after SCIT (after completion the 2nd or 3rd year of treatment)~     Group 2: completed SCIT more then three years ago Group 3: Patients with clinically relevant~     grass pollen allergy without SCIT.~      The investigators analyzed the lung function parameters, exhaled NO (eNO) and asked the~     patients to record symptoms during the adjacent pollen season. A blood sample was drawn to~     analyze the amount of TH1 and TH2 and regulatory T-cells, inflammatory markers(IL-2, IL-5,~     IL-10, IL-12/23, TNF-alpha, IFN-gamma) and blocking antibodies (IgG, IgG4).~   "
132678|NCT01830660|"~     Hetrombopag Olamine made by Jiangsu Hengrui Medicine co Ltd. has shown an effect of~     increasing platelet count in animal and human. This study is designed in dose escalation~     fashion to evaluate safety, pharmacokinetics and efficacy of Hetrombopag Olamine.~   "
132679|NCT01830647|"~     This prospective observational study will evaluate the safety and efficacy of first-line~     Avastin (bevacizumab) in combination with standard chemotherapy in routine clinical practice~     in patients with metastatic cancer of the colon and/or rectum. Patients will be followed for~     the duration of their treatment and a 30-day follow-up after the last dose of study drug.~   "
132680|NCT01830634|"~     Background: Accidental falls result in major physical and psychological morbidity in the~     elderly.~      Aim: To evaluate effects of lower-limb strength and flexibility program, which is analyzed~     under the control of other risk factors, on preventing recurrent falls and fall- related~     injuries in the community-dwelling elderly faller.~      Methods: The randomized double blind, longitudinal study will enroll about 780 elderly~     fallers, who are aged more than 70 years old. They are retrieved from the Adult Health~     Examination and allocated into intervention group and control group. All the fallers have at~     least one risk factor of accidental falls and no indication for exclusion criteria. Health~     professionals assess the risk factors of falls and provide medical educations and suggestions~     to all subjects concerning modification of environmental hazards, dizziness, multiple drugs~     use, and general transfer skill, etc. Physical therapists instruct the elderly of~     intervention group to do lower-limb strength and flexibility program by the aid of Theraband.~     There are three times of variables measurement at baseline, 6 months and 12 months after~     examination. Differences in baseline characteristics between groups are tested by independent~     samples t test, Mann Whitney U test, or Chi-square test. To compare the outcomes in different~     groups, the investigators evaluate balance and mobility with multiple linear regression,~     accidental falls or not with logistic regression, and all-related injuries with Cox's~     proportional hazard model.~   "
132681|NCT01830621|"~     The purpose of this study is to find out whether it is better to receive a new drug, BBI608,~     or better to receive no further treatment for colon or rectal cancer. To do this, half of the~     patients in this study will get BBI608 and the other half will receive a placebo (a substance~     that is designed not to do anything).~   "
132682|NCT01830608|"~     Age-related macular degeneration (AMD) is the leading cause of blindness in the Western~     World. The etiology and pathogenesis of this disease remain largely unknown. In Europe about~     two million people suffer from AMD. According to the Age-Related Eye Disease Study (AREDS)~     the disease can be classified into early, intermediate and late. Early age-related macular~     degeneration is characterized by the presence of small or medium-sized drusen and/or retinal~     pigmentary abnormalities. Intermediate age-related macular degeneration is characterized by~     large drusen or numerous medium-size drusen and/or geographic atrophy not extending to the~     center of the macula. Late age-related macular degeneration can be either atrophic with~     extension to the macula or neovascular. The late form of the disease is associated with a~     pronounced loss of visual acuity.~      In the recent years several studies focused on risk factors for late AMD and a recent~     systematic review and meta-analysis reported risk factors for AMD based on 16 studies in~     almost 114000 subjects. Strong and consistent associations with late AMD for found for~     increasing age, current cigarette smoking, previous cataract surgery, and a family history of~     AMD. Consistent associations between late AMD and higher body mass index, history of~     cardiovascular disease, hypertension and higher plasma fibrinogen were also found, but the~     association was weak. Inconsistent associations were found for gender, ethnicity, diabetes,~     iris color, history of cerebrovascular disease, serum total and HDL cholesterol and~     triglyceride levels.~      Evidence has also accumulated that other factors influence the risk for AMD. Several genetic~     risk factors have been identified in the last years including genes in the alternative~     complement pathway and the RMS2/HTRA1 region. In addition, post-hoc analysis of data from the~     AREDS study has indicated that reduced intake of the omega-3 free fatty acids~     eicosapentaenoic acid and docsahexaenoic acid are associated with the risk of late AMD~     thereby supporting previous population based studies. The AREDS study also revealed that~     reduced intake of the macular pigment lutein and zeaxanthin may be associated with late AMD,~     again supporting previous population-based studies. Finally, 2 small studies indicate that~     reduced choroidal blood flow is associated with an increased risk of developing late AMD.~      Less data are available for the progression of early or intermediate AMD and the associated~     risk factors. This is at least partially related to the problems in quantifying progression~     of drusen size and volume. In the recent years, however, significant efforts have been~     achieved in optical coherence tomography (OCT)-based methods for quantifying drusen~     progression and drusen volume. Polarization-sensitive OCT is the most promising of these~     approaches and will be used to quantify drusen area and volume in the present study.~   "
132683|NCT01830595|"~     Our general goal is to evaluate the potential effectiveness of recombinant lactoferrin~     (1500mg bid) for reducing inflammation among HIV positive participants.~   "
132684|NCT01830582|"~     The purpose of this study is to see whether three new types of MRI techniques used during~     magnetic resonance imaging (MRI) of the pelvis to look at rectal cancer can help doctors to~     tell if the tumor is getting better in response to the radiation and/or chemotherapy~     treatments.~   "
132685|NCT01830569|"~     The purpose of this study is to assess the feasibility of the use of an evidence-based~     decision support system (EBMeDS) in daily Belgian family medicine and to study the~     effectiveness of EBMeDS use on improving diabetes care.~   "
132686|NCT01830556|"~     Primary To investigate in patients with relapsed or metastatic squamous cell carcinoma of the~     head and neck whether progression free survival (PFS) in the arm with cetuximab, paclitaxel~     and carboplatin based chemotherapy is not markedly worse than PFS in the arm with cetuximab~     and 5-FU, cisplatin or carboplatin based chemotherapy.~      Secondary~      To compare in patients with relapsed or metastatic squamous cell carcinoma of the head and~     neck the following study variables between both treatment arms:~        -  Best overall response~        -  Duration of response~        -  Time to treatment failure~        -  Overall survival~        -  Safety~   "
132687|NCT01830543|"~     The primary purpose of this study is to evaluate the safety for 2 different rivaroxaban~     treatment strategies and one Vitamin K Antagonist (VKA) treatment strategy utilizing various~     combinations of dual antiplatelet therapy (DAPT) or low-dose aspirin (ASA) or clopidogrel (or~     prasugrel or ticagrelor).~   "
132688|NCT01830530|"~     This study is aimed to assess the efficacy of combined treatment with two antihypertensive~     agents (telmisartan and nifedipine) in subjects with mild hypertension exposed to high~     altitude.~   "
132689|NCT01830517|"~     This study was conducted to evaluate and compare the effectiveness of Amodipin® (amlodipine~     camsylate) with that of Cozaar® (losartan potassium) in hypertensive patients with an acute~     ischemic stroke by measuring their 24-hour ambulatory BP (ABP).~   "
132690|NCT01830504|"~     In France, 7-8 000 new thyroid cancer cases are diagnosed each year. Although a good overall~     prognosis, it is usually estimated that 10 to 20% will rescue and 5% will become metastatic.~      The standard treatment of advanced metastatic or recurrent thyroid cancer is limited to~     radioiodine therapy. It is estimated that 30 to 50% of patients will become resistant to~     radio iodine. Treatments options are limited in these refractory thyroid patients and long~     term survival is estimated to less than 10%. Nowadays, no drug is approved in this~     indication.~      The recent explosion in knowledge in tumour biology and the identification of potential~     biological targets in thyroid cancer led to several clinical trials with targeted therapies,~     mainly focused on TKI inhibitors targeting the MAPkinase pathway and/or VEGF. Preliminary~     results were encouraging in papillary thyroid tumors.~      Follicular (FTC) and poorly differentiated thyroid (PDTC) cancers account for 10% of thyroid~     cancer but 20-25% of cancers diagnosed at an advanced stage and near 50% of metastatic~     refractory thyroid cancers. These cancers with an aggressive behavior represent a major cause~     of death from thyroid cancer. In these subtypes, targeted therapies gave disappointing~     results. This may be related to the mutational profile of these tumors which is different~     from that of papillary cancers. Aberrant activation of the phosphatidylinositol-3-kinase~     (PI3K)/AKT pathway is thought to play a fundamental role in thyroid tumorigenenesis of~     follicular and poorly differentiated thyroid cancers. Many genetic alterations have been,~     recently, identified in this pathway. PIK3CA mutations are found in 10-15% of FTC and can~     also occur in metastases derived from PDTC. Amplification/genomic copy gain of the PIK3CA has~     been identified in 24% of FTC and 42% of PDTC. Epigenetic inactivation of PTEN which~     negatively regulates PI3K has been shown in FTC. Moreover, RAS mutations observed in 20-40%~     of FTC and PDTC can activate the PI3K/AKT by interacting with the RAS-binding site of the~     P110 catalytic subunit of PI3K.~      Due to the high frequency of activation of PI3K and downstream effectors in progressive,~     recurrent and poorly differentiated cancers, inhibition of the PI3K signaling pathway with~     BKM120, a potent pan class I PI3K inhibitor, represents a particularly relevant therapeutic~     target and should be properly evaluated in advanced follicular and poorly differentiated~     thyroid carcinomas~   "
132691|NCT01830491|"~     The aim of this study is to demonstrate that the combination therapy of aspirin and~     clopidogrel napadisilate is not inferior to that of aspirin and clopidogrel bisulfate with~     respect to its effectiveness in inhibiting platelet aggregation, if it is given for four~     weeks to Coronary Artery Disease (CAD) patients who had been treated with a drug-eluting~     stent before > 12 months and had remained in a stable condition with a single antiplatelet~     agent, aspirin.~   "
132692|NCT01830478|"~     The purpose of this study is to determine whether lenalidomide in association with rituximab~     is effective in the treatment of patients with indolent non follicular NHL relapsed after~     >=2, but less than 4 prior lines of (immuno)chemotherapy.~   "
132693|NCT01830465|"~     The aim of this study was to evaluate the efficacy and safety of the combination of Velcade~     and Rituximab in patients with relapsed Non Hodgkin's Follicular Lymphoma.~   "
132694|NCT01830452|"~     Chronic pain after Lichtenstein hernioplasty is a common problem with an incidence of 11%.~     Many factors influence the onset and persistence of pain. Mesh characteristics and fixation~     have been pointed as important etiologic factors. This study compares two types of fixation~     for the same mesh. The mesh used is a lightweight parietex mesh. In the control group this~     mesh will be fixed with non absorbable sutures. In the study group sutures will not be needed~     because of self gripping microhooks on the surface of the mesh.~      Methods: The HIPPO trial is a multicenter double blind randomized clinical trial. Patients~     will be randomly allocated to the sutured mesh or the self-gripping mesh. Hernia repair will~     be done according to Lichtenstein as described by Amid et all. Included will be all~     unilateral primary inguinal hernia in man patients aged 18 years or older not meeting the~     exclusion criteria. Patients will be followed for two years. The main endpoint is the amount~     of post-operative chronic pain evaluated by VAS scores. The existence of neuropathic pain~     will be evaluated by the Paindetect questionnaire (and a bedside variant of the QST).~     Secondary endpoints are recurrence rate, post-operative complications, costs, hospital stay,~     QOL, return to work and daily activities, genital and sexual problems. To demonstrate a~     difference in VAS score of 10 with α=0.05 and power 80% a sample size of 400 patients is~     calculated.~      Discussion: Hypothesized is that the self gripping non-sutured mesh (Parietex Progrip) will~     cause less post-operative and chronic pain without enhancing the recurrence rate.~   "
132695|NCT01830439|"~     This will be a Phase 1, single-center, randomized, balanced, single-dose, two-period,~     two-sequence, crossover, open-label study to evaluate the effect of food on the~     pharmacokinetics of PA-824. The hypothesis to be tested in this study is that the rate and~     extent of absorption of two doses of PA-824 (50mg or 400 mg and 200mg) are the same after a~     high-calorie, high-fat meal as compared with after a minimum 10-hour fast.~      For each of the two dose levels 16 subjects with approximately 8 men and 8 women, will be~     enrolled for a total of 32 subjects.~   "
132696|NCT01830426|"~     The purpose of this study is to establish the circulating tumor cell (CTC) assay as a~     surrogate for tissue diagnosis of suspected primary lung cancer. This is done through~     evaluating clinical and molecular markers to stratify the outcome/survival in patients with~     thoracic malignancies treated at Yale University/Yale-New Haven Hospital, University of~     California San Diego/Moores Cancer Center, Billings Clinic Cancer Center.~   "
132697|NCT01830413|"~     Stenting for systematic Intracranial artery stenosis is challenged recently, especially for~     safety. This registry is aimed to explore the safety profile during peri-operation period in~     Stenting procedures for systematic Intracranial artery stenosis in Chinese population in real~     world.~   "
132738|NCT01829867|"~     The purpose of this study is to assess the safety and tolerability of a dose of 95μg sNN0031~     after intracerebroventricular administration to patients with Parkinson's disease~   "
132698|NCT01830400|"~     This was a Non-interventional Prospective Study. Centres enrolled adult patients with~     partial-onset seizures with or without secondary generalisation for whom the clinician had~     decided to initiate Eslicarbazepine Acetate (ESL) as an adjunctive therapy prior to the~     decision to take part in this study. Patients enrolled into the study were not sufficiently~     controlled with one drug licensed for the use as monotherapy in partial-onset seizures.~     Patients were seen at baseline and then during normal clinical visits at intervals. Patients~     in this study were assessed for efficacy and tolerability at baseline and then at least 3 and~     6 months after the baseline.~   "
132699|NCT01830387|"~     The purpose of this study is to compare the clinical outcomes and the operative costs of~     appendectomy performed with the Hem-O-Lok polymetric clips compared to endoscopic staplers.~     Prospective data will be collected before, during, and after surgery on patients undergoing a~     laparoscopic appendectomy that have the Hem-o-Lok ® stapler used to close the stump after the~     appendix is removed. Use of the Hem-o-Lok ® stapler is standard for appendectomy patients at~     Duke Regional Hospital. Retrospective data will be collected from patients who had an~     appendectomy prior to 1/2012 using a different clip as part of their surgery, or an open~     appendectomy to compare outcomes.~   "
132700|NCT01830374|"~     The purpose of this study is to examine biological (e.g., energy expenditure, neuroendocrine~     and appetitive hormones)and behavioral (e.g., binge eating and purging) correlates of weight~     suppression and current dieting status in women with bulimia nervosa. The investigators have~     differentiated between a diet-induced long-term energy imbalance (weight suppression, or the~     difference between one's highest-ever body weight and current weight) and a short-term energy~     imbalance (current dieting to either lose weight or avoid weight gain). This study will~     elucidate how two common yet largely unexplored types of dieting influence biological and~     behavioral variables in patients with bulimia nervosa, which could lead to modifications of~     prevailing models of bulimia nervosa and new strategies for improving treatment outcome.~   "
132701|NCT01830361|"~     To assess the efficacy of tyrosine-kinase inhibitor midostaurin in c-KIT or FLT3-ITD mutated~     t(8;21) AML. To assess the efficacy of midostaurin depending on the type of c-KIT mutation~   "
132702|NCT01830348|"~     The purpose of the study is to determine if DSC127 is effective in increasing incidence of~     complete wound closure at 10 weeks confirmed at a visit 2 weeks later when compared to the~     vehicle (gel without active ingredient) in subjects with diabetes mellitus (DM) who have~     chronic Wagner Grade 1 or 2 plantar neuropathic foot ulcers, 0.75 - 6 cm2 in size.~   "
132703|NCT01830335|"~     Environmental stress, such as low oxygen availability (hypoxia), has been associated with~     impaired neuromuscular performance; however, the mechanisms associated with these performance~     decrements remain unclear. While the majority of research suggests that the observed fatigue~     is related to the central nervous system, the influence of changes in cerebral blood flow~     (CBF) and associated changes in cerebral pH (partial pressure of carbon dioxide; PCO2)~     remains unexamined. In response to hypoxic stress, humans hyperventilate to maintain oxygen~     consumption, resulting in a hypocapnia mediated decrease in CBF and cerebral alkalosis~     (decreased PCO2). Previous research suggests that hyperventilation induces changes in neural~     excitability and synaptic transmission; however, it remains unclear if these changes are~     related to hypocapnia mediated decrease in CBF or cerebral alkalosis or both.~      The purpose of the proposed research program is to examine the influence of changes in CBF~     and cerebral alkalosis on neuromuscular function during environmental stress. The research~     program will consist of 2 separate projects, summarized below in a table outlining the~     proposed protocols and resultant physiological manipulations. During each manipulation,~     neuromuscular function will be evaluated and compared to baseline (normoxic) conditions using~     a repeated measures design.~      The research program will consist of 2 separate projects. Project 1 will examine the changes~     in CBF and alkalosis by using (a) indomethacin (decrease CBF; no change PCO2) and (b)~     hypocapnia (decrease CBF; decrease PCO2). Using a similar experimental design, Project 2 will~     examine the change in CBF and alkalosis during hypoxia by using (a) poikilocapnic hypoxia~     (decrease PO2; decrease CBF; decrease PCO2), (b) isocapnic hypoxia (decrease PO2; no change~     CBF; no change PCO2) and (c) isocapnic hypoxia + indomethacin (decrease PO2; decrease CBF; no~     change PCO2). During each manipulation, neuromuscular function will be evaluated and compared~     to baseline (normoxic) conditions using a repeated measures design.~      Therefore, Project 1 will examine the separate and combined effect of changes in CBF and~     cerebral alkalosis on neuromuscular function independent of environmental manipulations.~     Subsequently, Project 2 will examine neuromuscular function during hypoxia while controlling~     CBF and cerebral alkalosis. It is hypothesized that changes in PCO2 and therefore, changes in~     cerebral alkalosis will contribute to neuromuscular fatigue independent of changes in CBF and~     oxygen availability.~   "
132704|NCT01830322|"~     This Phase II study is conducted to assess the safety and efficacy of CPI-613 in patients~     with metastatic pancreatic cancer. The primary outcome measure is Overall Survival (OS). The~     secondary outcome measures are: changes in CA 19-9, Quality of Life (QOL), Progression-Free~     Survival (PFS), and safety.~   "
132705|NCT01830309|"~     -  Primary: To evaluate food effect on the pharmacokinetics (PK) of a single oral dose of~          CJ-12420 in healthy male subjects.~        -  Secondary~             -  To explore food effect on the pharmacodynamics (PD) of single oral dose of CJ-12420~               in healthy male subjects(PD/PK group)~             -  To evaluate the safety of single oral dose of CJ-12420 in healthy male subjects~               under fed or fasting condition.~   "
132706|NCT01830296|"~     Background; Post-thoracotomy pain remains a major problem. This double-blind, randomized~     study tested the effects of coadministration of patient controlled remifentanil+morphine~     combination on postthoracotomy pain, analgesic consumption and side effects compared with~     morphine PCA alone~   "
132707|NCT01830283|"~     To investigate the safety, immunogenicity and immune effect of the Varicella vaccine after~     the 2nd dose vaccination in Chao yang district, Bei jing, since the 2nd varicella vaccination~     was promoted by Beijing Center for Disease Control and Prevention in November, 2012.~   "
132708|NCT01830270|"~     If surgery remains the main treatment for gastric cancer without distant metastases;~     perioperative-chemotherapy increased the likelihood of progression free survival.~     Perioperative chemotherapy appears to have many advantages : to reduce the tumor volume, to~     improve the R0 resection rate, and to act on micro-metastases. Therefore, peri-operative~     chemotherapy combining cisplatin, epirubicin and 5-Fluorouracile is a validated strategy to~     treat gastric cancer. However, several pitfalls remained. Particularly, only 42% of patients~     could received post-chemotherapy, due to post-operative complications and toxicities. To~     overcome this limitation, the investigators will conduct a phase II clinical trial assessing~     the clinical interest of a dose-dense preoperative chemotherapy combining cisplatin (P),~     epirubicin (E) and paclitaxel (T). The increasing evidence of taxane's role in gastric cancer~     treatment, as well as the biological synergisms reported in paclitaxel/cisplatin and~     paclitaxel/epirubicin combinations, sustain the development of dose density based on PET~     combination in gastric carcinoma. The aim of the IPEC-GC study is to evaluate the~     effectiveness of this PET preoperative regimen~   "
132709|NCT01830257|"~     The investigators would remind the guardians of observation after immunization via sending~     short message and collect the information of AEFI by two ways, short message/telephone and~     website questionnaire.~   "
132739|NCT01829854|"~     This is a study to investigate the incidence of Obstructive Sleep Apnoea in Patient~     undergoing open heart Surgery . This will include enrolment of 400 patient undergoing open~     heart surgery .~   "
132710|NCT01830244|"~     The aim of this project is to evaluate tailored primary systemic therapy with sequential nab~     paclitaxel and epirubicin and cyclophosphamide in early breast cancer. This study will be an~     open label phase II clinical trial. The hypothesis is that tailored neoadjuvant chemotherapy~     with sequential nab paclitaxel and epirubicin and cyclophosphamide is feasible and achieves~     high response rates. It is proposed that 60 patients will be enrolled in this study including~     40 patients which are likely to have chemotherapy sensitive tumors and 20 patients who have~     ER positive tumors and are more likely to respond to hormonal treatment as an exploratory~     cohort. The target population is women with early breast cancer who are eligible for primary~     systemic therapy. The overall response rate in the breast will be measured. Secondary~     endpoints will include response rates in axillary lymph nodes, safety and tolerability and~     the rate of breast conservation. Participants will have a blood test to determine a specific~     genotype status that may help in predicting sensitivity to chemotherapy. This genotype test~     result is exploratory and will not influence selection of therapy for participants. Patients~     will also be given the option of having he their tumour tissues used in laboratory studies~     involving isolating cancer initiating cells from the tumor to subsequently generate breast~     cancer models in the laboratory and using aptamers (chemical antibodies) to target tumours.~   "
132711|NCT01830231|"~     Due to limited experience with cabazitaxel in TCCU, the study will be started as a randomised~     phase II study. The aim of the phase II study is to evaluate if the response rates (CR + PR)~     are sufficiently high to further study the treatment regimens in a phase III setting.~   "
132712|NCT01830218|"~     A national survey of current practices, preferred drug and technique choices for obstetric~     anesthesia and analgesia in Czech Republic.~   "
132713|NCT01830205|"~     The purpose of this study is to assess the effect of renal function impairment on the single~     dose pharmacokinetics of Daclatasvir.~   "
132714|NCT01830192|"~     The purpose of this study was to obtain a predictive model to asses the Risk of Endometrial~     Malignancy (REM) in women with ultrasound endometrial abnormalities.~   "
132715|NCT01830166|"~     This project will develop and evaluate a treatment plan for prostate focal therapy based on~     low dose rate brachytherapy. The participants entering this study are those suitable for~     active surveillance. These participants will be monitored with various imaging methods and~     interventions such as MR elastography, Transrectal ultrasound elastography, PET/CT and~     transperineal mapping biopsy to determine the extent of cancer and suitable treatments. Those~     suitable for focal therapy will be offered the option of low dose rate brachytherapy (LDRB)~     focal therapy in addition to active surveillance or radical therapy.~      This study will be used to evaluate the long term use of multi-modal, multi-parametric~     prostate cancer imaging, combining data from MRI, ultrasound and 11C-choline PET/CT. Such~     methods can be used to eliminate the need for invasive methods such as mapping biopsies.~   "
132716|NCT01830153|"~     This trial intends to test the efficacy and safety of RAD001 in patients with advanced~     sarcoma who failed to conventional chemotherapy.~   "
132717|NCT01830140|"~     This safety study will evaluate bimatoprost 0.01% and 0.03% in patients with glaucoma or~     ocular hypertension (OHT).~   "
132718|NCT01830127|"~     To assess the pharmacokenetic characteristics of 600 mg BID BI 207127 / 120 mg QD faldaprevir~     /ribavirin in a small number of GT1b HCV infected patients with mild hepatic impairment (CPA)~     (Arm 1) versus 400 mg BID BI 207127 / 120 mg QD faldaprevir /ribavirin in a small number of~     GT1b HCV infected patients with moderate hepatic impairment (CPB) (Arm 2).~   "
132719|NCT01830114|"~     The objective of this pilot study is to evaluate the feasibility and technical merit of a web~     application for patients in primary care called Check-up and Choices (CC).~   "
132720|NCT01830101|"~     The investigators hope to improve overall median survival of patients with recurrent~     Glioblastoma by investigating continuous low-dose daily Temozolomide plus or minus five~     treatments of re-irradiation.~   "
132721|NCT01830088|"~     Major depressive disorder (MDD) affects about 5% of adolescents and is on the rise both~     internationally and in Norway. Further, it is also associated with increased risk for~     suicide. Not surprisingly, depression is the largest reason for referral to specialty mental~     health services for adolescents (13-17 years) in Norway. Although anti-depressants and~     Cognitive behavioral therapy are strong treatments and have received extensive research, the~     best treatments show a recovery rate of only 37 %.~      There is a need to develop and test alternative treatments that can stand alone or augment~     anti-depressant medication. Family factors play an important role in the etiology,~     maintenance and relapse of depression. A promising family-based treatment (Attachment based~     family therapy- ABFT) was imported to Norway and its feasibility tested in a pilot randomized~     clinical trial with 20 families. The results showed promising treatment outcomes. Although~     the developers of the model have refined, adapted the model to suicidal ideation and built~     strong technology to support dissemination, a definitive study of ABFT for adolescents with~     major depression has not yet been conducted. Therefore the primary aim of this study is to~     test if ABFT is more effective that enhanced usual care (EUC) to treat clinic-referred~     adolescents with major depression. The investigators will test the hypothesis that 12 weeks~     of ABFT therapy will produce a greater proportion of adolescents report remission from~     depression and symptom change than 12 weeks of enhanced clinical care (EUC). Secondary~     research aims are i) to test a hypothesis that parent-adolescent conflict will be more~     sensitive to change for adolescents receiving ABFT that adolescents receiving EUC ii) to~     explore patterns of change in suicidal ideation in the recruited sample in the acute-phase~     treatment.~      Central challenges to the study are i) blinding therapists/patients, which is difficult in~     psychotherapy trials ii) lack of a standardized control condition, and iii) selecting and~     training regular staff therapists to high adherence levels. However, with tighter control~     over these factors than is normal for a typical effectiveness trial, the investigators expect~     results to show what to expect under the best of conditions in community clinics. Benchmark~     derived from the study will inform how to effectively train therapists and subsequently~     implement the model into mainstream services.~   "
132722|NCT01830075|"~     Background:~      It is widely recognised that spiritual care plays an important role in physical and~     psychosocial well-being of cancer patients but there is little evidence based research on the~     effects of spiritual care. The investigators will conduct the first randomized controlled~     trial on spiritual care using a brief structured interview scheme supported by an~     e-application. The aim is to examine whether an assisted reflection on life events and~     ultimate life goals can improve quality of life of cancer patients.~      Design:~      Based on the findings of the investigators previous research, the investigators have~     developed a brief interview model that allows spiritual counselors to explore, explicate and~     discuss life events and ultimate life goals with cancer patients. To support the interview,~     the investigators created an e-application for a PC or a tablet. To examine whether this~     assisted reflection improves quality of life the investigators will conduct a randomized~     trial. Patients with advanced cancer not amenable to curative treatment options will be~     randomized to either the intervention or the control group. The intervention group will have~     two consultations with a spiritual counselor using the interview scheme supported by the~     e-application. The control group will receive care as usual. At baseline and one and three~     months after randomization all patients fill out questionnaires regarding quality of life,~     spiritual wellbeing, empowerment, satisfaction with life, anxiety and depression and health~     care consumption.~      Discussion:~      Having insight into one's ultimate life goals may help to cope with a life event such as~     cancer. This is the first randomized controlled trial to evaluate the role of an assisted~     structured reflection on ultimate life goals to improve patients' quality of life and~     spiritual well being. The intervention is brief and based on concepts and skills that~     spiritual counselors are familiar with, it can be easily implemented in routine patient care~     and incorporated in guidelines on spiritual care.~   "
132724|NCT01830049|"~     Erectile dysfunction (ED) is strongly associated with aging. With the rapidly expanding aging~     population and the increase in life expectancy, an increase in the prevalence of ED is~     expected in the years to come. Currently, the mechanism of ED is not fully understood.~     MicroRNAs (MiRNA) are endogenous small RNA molecules that control gene expression~     post-transcriptionally. It has been included in many in vitro physiology and pathophysiology~     processes, which also involved in the process of ED. This research was designed to~     investigate the differential plasma MiRNA profiles in ED and normal erectile function in~     older males. The results might tell us which MiRNA and how did it involved in the process of~     ED in aging.~   "
132725|NCT01830036|"~     Prevalence of sleep-related breath disturbance in patients in cardiac rehabilitation.~      The aim of the register is to enable a better diagnosis and early treatment initiation in the~     context of secondary prevention. In addition to the prevalence, the further course of the~     patients shall be documented after hospital discharge to verify any gaps (sleep laboratory,~     therapy introduction) and emphasize the importance of rehabilitation and to examine the~     possibility of initiating therapy in rehabilitation.~   "
132726|NCT01830023|"~     This study´s aim is to collect data of vitality diagnosis. A cardiac ultrasound examination~     will be done and the data will be compared to the other examinations.~   "
132727|NCT01830010|"~     Two part study to evaluate the safety, tolerability, pharmacokinetics, and efficacy (in Part~     2 only) of KRP203 in patients undergoing allogeneic hemopoietic stem cell transplant for~     hematological malignancies~   "
132728|NCT01829997|"~     Spine fusion is one of the most common procedures performed in spinal surgery. Several~     surgical techniques can achieve a solid union, but the intertransverse posterolateral fusion~     (PLF) is the most widely used. However, complications can develop when the bone graft~     material used is insufficient to achieve the desired fusion. With its unique properties,~     nanOss Bioactive 3D can be mixed with bone marrow aspirate (BMA) and autograft bone to obtain~     new bone growth during the healing process.~      nanOss Bioactive 3D is approved for use in the U.S., however, additional information is~     useful to assess its efficacy in the posterolateral spine. The purpose of this study is to~     assess fusion results in the posterolateral spine using nanOss Bioactive 3D mixed with~     autograft bone and BMA. It is hypothesized that the use of nanOss Bioactive 3D will result in~     fusion at 12 months, with CT evidence of bridging trabecular bone, less than 3mm of~     translational motion, and less than 5 degrees of angular motion.~   "
132729|NCT01829984|"~     The purpose of this study is to compare two different ways of teaching people how to give~     injections at home. The first is what we do now, which is teaching patients and/or their~     caregivers verbally and by giving written instructions. The second is what we do now (verbal~     and written instructions) along with a demonstration and practice using a needle and an~     injection pad that feels similar to skin and fat. This is being done to find the best method~     for teaching people to give an injection at home.~   "
132730|NCT01829971|"~     This is a study to evaluate the safety of MRX34 in patients with primary liver cancer or~     other selected solid tumors or hematologic malignancies. The drug is given intravenously, for~     5 days in a row and then two weeks off.~   "
132731|NCT01829958|"~     This study will evaluate the ability of a largely self-administered geriatric assessment (GA)~     to predict toxicity in non-Hodgkin Lymphoma (NHL) patients ≥60 years old receiving~     chemotherapy or chemoimmunotherapy.~   "
132732|NCT01829945|"~     Several lines of evidence indicate that a significant proportion of cardiovascular disease~     (CVD) events are attributable to the presence of a cluster of metabolic abnormalities and~     perturbations, defined as the metabolic syndrome. It has been estimated that approximately~     25% of the North American adult population is living with the metabolic syndrome. Recent~     studies show that overaccumulation of atherogenic triglyceride-rich lipoproteins (TRL) seen~     in insulin-resistant patients is partly due to increased production rate of intestinally~     derived apolipoproteinB-48-containing lipoproteins. This is of interest because substantial~     evidence exists indicating that elevated levels of intestinal lipoproteins are associated~     with increased CVD risk. However, as indicated in the body of this grant proposal, the~     underlying mechanisms that lead to intestinal overproduction of lipoproteins in~     insulin-resistant states are poorly understood.~      The general objective of the proposed research is to investigate the mechanisms by which the~     metabolic syndrome affects apolipoproteinB-48 secretion in human. The primary hypothesis is~     that insulin resistance will be associated with higher levels of intestinal lipoproteins~     because of an increased secretion of these particles.~   "
132733|NCT01829932|"~     Irritable bowel syndrome (IBS) is a chronic gastrointestinal illness of unknown cause whose~     symptoms include abdominal pain, bloating and altered bowel pattern. Diet has been shown to~     influence the bacteria gut interaction. Our aim is to determine if components of the diet~     affect IBS symptoms by changing the bacteria gut interaction. In particular, we will measure~     whether after being on a diet high or low on certain factors there is a change in the timing~     and amount of hydrogen and methane produced by bacteria digesting lactulose and on IBS~     symptom severity.~   "
132734|NCT01829919|"~     The purpose of this study is to assess the pharmacokinetics (absorption, breakdown and~     elimination from the body), safety and tolerability of Brisdelle (paroxetine mesylate)~     Capsules 7.5 mg when given as a single dose and multiple doses.~   "
132735|NCT01829906|"~     Bariatric surgery is the only long-term established treatment for morbid obesity. However,~     some patients experience suboptimal weight loss after surgery and/or experience a significant~     weight regain. Unfortunately there are very few studies in this area and little is known~     about the causes for lack of success or the best approach to treat this group of patients.~     The main aim of this study is to compare the efficacy of two different lifestyle treatment~     programs in this group of patients: 1) Hospital-based outpatient program or 2) an inpatient~     treatment program consisting of 3 - 3-week stays at a rehabilitation center over a 1-year~     period. Secondary aim is to determine potential reasons for suboptimal weight loss after~     bariatric surgery.~   "
132736|NCT01829893|"~     To compare the relative bioavailability and pharmacokinetic characteristics of a newly single~     pill combination of finasteride and tamsulosin with a conventional combination of finasteride~     and tamsulosin in healthy subjects with a single dose, randomized, open-label, 2-sequence~     -2period crossover study.~   "
132737|NCT01829880|"~     The purpose of this study is to determine if cachexia and changes in body composition~     influence pharmacokinetics of bisoprolol and ramipril and the accuracy of equations for renal~     function estimation.~   "
132742|NCT01829815|"~     The aim of this study is to assess the impact of an intervention to improve parenting~     practices, pre-academic and developmental skills, and use of mosquito nets for children in~     kindergarten in Liberia. A rigorous impact evaluation using a randomized, waitlist controlled~     design will be conducted to measure the impact of the intervention on three primary outcomes:~     positive parenting skills, children's cognitive and educational skills, and malaria knowledge~     and prevention behaviors.~   "
132743|NCT01829802|"~     The purpose of this pilot study is to assess the efficacy and safety of the combination of~     RAL+ATV/r in comparison with TDF/FTC+ATV/r in HIV-1 infected patients presenting virologic~     failure and PI and TDF naïve.~   "
132744|NCT01829789|"~     The purpose of this study is to test the efficacy and cost-effectiveness of Community~     Reinforcement Training (CRT) provided in a group therapy format. The goals of CRT are to~     teach parents behavioral and communication skills to influence their youth's drug use and~     encourage them to enter treatment. Thirty parents will be randomly assigned to Group CRT and~     30 will be randomly assigned to traditional, Individual CRT. Youth engaged in treatment will~     receive individual Cognitive Behavioral Therapy. Families are assessed for adolescent~     substance use and other areas of individual and family functioning. It is expected that Group~     CRT will be more effective for encouraging youth entry into treatment and improving parental~     functioning.~   "
132745|NCT01829776|"~     This pilot study will compare how often people with multiple sclerosis (MS) fall before~     participating in the Free From Falls (FFF) educational program, during the program, and for 8~     weeks after the program. The protocol will also evaluate the accuracy, efficiency and~     convenience of an email survey to count how often people fall.~   "
132746|NCT01829763|"~     Spasticity is a motor disorder characterized by a velocity-dependent increase in tonic~     stretch reflex with exaggerated tendon jerk (Lance 1980). Patients with brain lesion often~     display spasticity due to the interruption of the descending pathways that control the spinal~     reflex networks, which results in hyperexcitability of the monosynaptic reflex triggered by~     stretch of the muscle spindles. Spasticity in lower limb muscle impairs the gait, especially~     in strokes that are the main cause of neurological disability. While 80% of the stroke~     survivors recover the ability to walk, the poor quality of their gait constitutes a serious~     handicap in daily life (Bensoussan et al. 2004; Bensoussan et al. 2006).~      Local injection of Botulinum toxin (BTx) has become a mainstay of the treatment of focal~     spasticity, particularly in post-stroke patients. BTx weakens the excessive muscle~     contraction by blocking the release of acethylcholine from motoneuron terminals at the~     neuromuscular junction and transiently paralyzing the muscle for several months. Besides this~     peripheral action, BTx is assumed to have also a central effect (Curra et al. 2004; Gracies~     2004; Krishnan 2005; Palomar and Mir 2012). In particular, by affecting also the fusimotor~     synapses on intrafusal muscles fibers (Rosales and Dressler 2010; Trompetto et al. 2008;~     Trompetto et al. 2006), BTx may reduce the discharge from muscle spindles, which may be~     indirectly responsible for functional changes in central motor mechanisms at both spinal and~     supraspinal levels. Animal experiments also suggested that BTx is carried by retrograde~     axonal transport to motoneuron soma and possibly transynaptically, and can affect the spinal~     cholinergic synaptic transmission in the spinal cord. Until now, electrophysiological~     findings are limited and controversial, probably due to the various motor disorders~     investigated, the physiological mechanisms tested and the different toxin injection protocols~     used in the few studies available (Frascarelli et al. 2011; Girlanda et al. 1997; Modugno et~     al. 1998; Naumann and Reiners 1997; Pauri et al. 2000; Priori et al. 1995; Wohlfarth et al.~     2001). Hence, the central action of the toxin in spasticity remains uncertain.~   "
132747|NCT01829750|"~     The purpose of this study is to investigate the efficacy of intracoronary infusion of cardiac~     progenitor cells in patients with univentricular heart disease. Patients with preoperative~     high-risk group or whose cardiac function did not recover postoperatively eventually have no~     choice other than heart transplantation.~   "
132748|NCT01829737|"~     Background:~      - Malaria is an illness caused by a parasite spread by mosquitoes. When a mosquito bites a~     person who is infected with a kind of parasite called a gametocyte, it is able to spread the~     infection to another person. Not everyone infected with parasites have gametocytes in their~     blood. As a result, not everyone can spread malaria to others. Researchers are interested in~     learning more about why some healthy people have gametocytes in their blood and others do~     not. Identifying the people who have gametocytes in their blood can help target treatment and~     reduce the spread of malaria. This study will focus on the people of the village of Kenieroba~     in Mali, where malaria is common.~      Objectives:~      - To study the relationship between gametocytes and malaria transmission in Mali.~      Eligibility:~      - Individuals between 6 months and 65 years of age who live in Kenieroba, Mali, and will stay~     in the area for 1 year.~      Design:~        -  For 1 year, participants will have study visits once every 2 weeks (twice a month, for a~          total of 24 visits). The visits will last 30 minutes each.~        -  At each visit, participants will provide a small blood sample. They will report any~          symptoms of malaria such as fever, headache, and body aches. Participants will be~          encouraged to seek medical treatment if they experience malaria symptoms between visits.~        -  Participants who have malaria symptoms will have a blood test for malaria parasites.~          Those who have parasites in the blood will receive antimalarial treatment.~        -  Three times over 1 year, a larger blood sample will be collected. These blood samples~          will be taken once in the dry season, once in the wet season, and once in the next dry~          season.~        -  Women between 14 and 45 years of age will also provide urine samples to test for~          pregnancy. Pregnant women will not be asked to give blood samples.~   "
132749|NCT01829724|"~     Background:~      - Two ways to study the brain while people are moving are near-infrared spectroscopy (NIRS)~     and electroencephalography (EEG). NIRS uses light to look at blood flow in the brain when it~     is active. EEG records electrical activity in the brain. Both have been used safely for many~     years, even in very young children. NIRS or EEG can be used while a person is moving to show~     which parts of the brain are the most active. Researchers want to use NIRS and EEG to study~     brain activity during movement in people with cerebral palsy and healthy volunteers. Learning~     more about how people with and without cerebral palsy use their brain to control their~     muscles may lead to new ways of training people with cerebral palsy to move better.~      Objectives:~      - To study how the brain controls body movement in people with and without cerebral palsy.~      Eligibility:~        -  Individuals at least 5 years of age who have cerebral palsy.~        -  Healthy volunteers at least 5 years of age.~      Design:~        -  This study has three parts. People with cerebral palsy will be selected for all three.~          Healthy volunteers will be asked to do only two of them. Everyone who participates will~          have NIRS and/or EEG exams during movement. People with cerebral palsy may also have~          biofeedback sessions to train coordination of movement and brain activity.~        -  Participants will be screened with a physical exam and medical history. Urine samples~          may be collected.~        -  All participants will have at least one session of NIRS and/or EEG imaging studies.~          Sessions may also include the following tests:~        -  Magnetic resonance imaging to look at the brain~        -  Electromyography to measure electrical activity of the muscles~        -  Motion analysis of specific body parts~        -  Ultrasound to measure activity of the muscles~        -  Motorized, robotic, and electrical stimulation of the muscles~        -  Other clinical tests of muscle movement as needed.~        -  Participants with cerebral palsy will have biofeedback sessions. These sessions will~          help them learn to coordinate muscle movement and brain activity.~   "
132750|NCT01829711|"~     Background:~      - Moxetumomab pasudotox is an experimental non-chemotherapy cancer treatment drug. It targets~     CD22, a molecule on the surface of essentially all hairy cell leukemia cells. Moxetumomab~     pasudotox binds to CD22, goes into the cell, and releases a toxin which kills the cell. In a~     phase I trial it had activity in relapsed/refractory hairy cell leukemia with safety profile~     supporting further clinical study (http://ncbi.nlm.nih.gov/pubmed/22355053). This is a phase~     III multicenter trial designed to confirm these results.~   "
132760|NCT01829581|"~     Intracerebral hemorrhage [ICH] is the most feared complication of anticoagulant therapy~     [OAC]. Evidence regarding acute therapeutic interventions as well as secondary treatment~     approaches is still limited. Therefore, this German-wide observational cohort study will~     retrospectively identify and evaluate all OAC-associated ICH patients that have been admitted~     to the 20 participating tertiary centres over a 5-year period. The main focus of this~     investigation, besides epidemiological aspects, will be the (i) acute management of OAC-ICH,~     (ii) secondary therapy (anticoagulant management) and (iii) long-term outcome after OAC-ICH.~   "
132751|NCT01829698|"~     Though ursodeoxycholate acid (UDCA) is the well known effective therapy for PBC,clinical~     effectiveness of UDCA may be limited by its poor absorption and extensive~     biotransformation.The more hydrophillic bile acid tauroursodeoxycholate (TUDCA) is the active~     ingredients of UDCA,and has been approved by state food and drug administration in China for~     treatment of cholesterol stones.So it is necessary to verify the efficacy and safety of TUDCA~     in the treatment of adult primary biliary cirrhosis. In this randomized, double-blinded,~     double -dummy, parallel-controlled and multicenter clinical trial, we detect the proportion~     of patients who had AKP decline more than 25% as the primary outcome;decline of ALP,total~     bilirubin, GGT,ALT and AST as secondary outcomes after patients were treated with TUDCA or~     UDCA for 24 weeks.~   "
132752|NCT01829685|"~     The purpose of this study is to compare the long-term efficacy and safety of entecavir 1.0~     mg/d + adefovir 10 mg/d with entecavir 0.5 mg/d + adefovir 10 mg/d for chronic hepatitis B~     patients with inadequate response to NUC therapy~   "
132753|NCT01829672|"~     The aim of the study is to determine relevant hemodynamic parameters for the diagnostics of~     pulmonary arterial hypertension (PAH) by dynamic contrast enhanced dual-energy CT (DE-CT). In~     this prospective study the investigators validate DE-CT results of patients against~     hemodynamic parameters from right heart catheterisation and control the results by other~     clinical investigations. The investigators expect that using this non-invasive method,~     parameters relevant for the diagnosis of the patients with PAH, like pulmonary blood volume,~     blood flow and perfusion heterogeneity, can be determined.~   "
132754|NCT01829659|"~     This study is being done to assess the effects of the CTP inhibitor on the function of your~     platelets (cells within your blood that are involved in the formation of blood clots) and to~     assess whether you have responded to the ticagrelor well enough to prevent the formation of~     blood clots within the stent or site in which angioplasty was performed.~      Recent studies have looked at how racial differences can affect platelet reactivity, the way~     blood clots. But these studies have not looked at the way different racial backgrounds can~     affect the way the blood forms clots. Minorities, such as African-Americans are~     underrepresented. Therefore, we are conducting this platelet reactivity study to better~     understand if there are differences in how this drug affects African-Americans from how they~     affect Caucasian patients undergoing percutaneous coronary intervention and receiving~     ticagrelor. These data will be compared to a historical control of Caucasian patients who~     underwent similar platelet function testing.~   "
132755|NCT01829646|"~     Despite uniform histopathological definition the response of locally advanced squamous cell~     carcinomas of the head and neck (HNSCC) to ionizing radiation differs greatly with~     locoregional recurrences burdening this patient population. The addition of concurrent~     chemotherapy and the use of altered fractionation schedules has significantly increased~     locoregional control and overall survival over the last decade however, this has come at the~     cost of increased acute and late toxicity, preventing further treatment intensification in~     all patients. If the investigators want to increase the therapeutic index of HNSCC, we need~     to be able to tailor the treatment more individually to each patient. The project aims at~     developing a prognostic model for head and neck cancer patients based on the combination of~     known clinical parameters with 1) genetic characteristics of the tumor and 2) parameters~     derived from diffusion weighted and dynamic contrast enhanced magnetic resonance imaging~     (MRI) obtained before and during treatment. The investigators plan a prospective trial where~     120 patients with locally advanced head and neck cancer treated with chemoradiotherapy will~     be included. Prior to treatment biopsy material will be collected for genetic analysis and~     before and during treatment functional MRI with diffusion weighted and dynamic contrast~     enhanced imaging will be performed. All patients will be followed up multidisciplinary~     afterwards with follow-up of tumor status and toxicity.~   "
132756|NCT01829633|"~     Study population: Patients who have been treated with physiotherapy for a potentially~     repairable rotator cuff tear in the period from 2002 to 2005.~      Study Method: At the time of diagnosis (2002 to 2005) all study patients were examined~     clinically, sonographically and by MRI. Some patients also completed a shoulder score. All~     study patients will now be reexamined, 8 to 10 years after they were diagnosed. Reexamination~     includes history taking, clinical examination, completion of three shoulder scores (two~     shoulder specific scores, one general health score), Sonography and MRI. Findings of interest~     are~        -  the number of relapses during follow-up,~        -  the need for surgical treatment during follow-up,~        -  the deterioration of tear anatomy (tear size, muscle atrophy, fatty degeneration) during~          follow-up~        -  the actual clinical shoulder condition (as given by shoulder scores) at reexamination.~      Study purpose: We want to assess the anatomic and clinical long-term results of physiotherapy~     for potentially repairable rotator cuff tears. We want to find out if tear anatomy of~     unrepaired rotator cuff tears deteriorates over time and if such a deterioration is~     associated with a development of more serious degrees of symptoms.~   "
132757|NCT01829620|"~     The investigators propose to utilize text messaging to create and investigate the efficacy of~     a Continuing Contacts via Text (CCVT) intervention that extends the continuity of care for~     Service Members with a recent suicide attempt and/or reported suicidal ideation by sending~     them non-demanding caring text messages at regular intervals over a 12-month period.~     Participants will be randomly assigned to receive Continuing Contacts via Text (CCVT) in~     addition to Treatment as Usual (TAU) or TAU alone.~      Aim 1: To determine if the addition of 12 months of CCVT to TAU (CCVT+TAU) results in lower~     rates of suicidal ideation and behavior relative to TAU alone.~        -  Hypothesis 1a: Participants assigned to CCTV+TAU compared to TAU alone will experience~          reduced suicidal ideation at 12-month follow-up.~        -  Hypothesis 1b: Over the 12 months following study enrollment, a smaller proportion of~          participants assigned to CCVT+TAU vs. TAU alone will have suicide risk incidents (i.e.,~          those requiring medical evacuation or hospital admission).~        -  Hypothesis 1c: Over the 12 months following study enrollment, CCVT+TAU vs. TAU alone~          will have fewer total number of suicide risk incidents requiring medical evacuation or~          hospital admission.~      Aim 2: To test two proposed mechanisms of action of CCVT outcome: 1) reduced thwarted~     belongingness and 2) increased engagement in behavioral health services.~        -  Hypothesis 2a: The effect of CCVT+TAU compared to TAU alone will be mediated by~          reductions in thwarted belongingness from pre to post-study.~        -  Hypothesis 2b: The effect of CCVT+TAU compared to TAU alone will be mediated by~          increased use of outpatient behavioral health services in the CCVT+TAU condition.~   "
132761|NCT01829568|"~     This phase I clinical trial studies the side effects and best dose of lenalidomide and~     ibrutinib when given together with rituximab in treating patients with previously untreated~     stage II-IV follicular lymphoma. Lenalidomide may stimulate the immune system in different~     ways and stop cancer cells from growing. Ibrutinib may stop the growth of cancer cells by~     blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as~     rituximab, can find cancer cells and help kill them. Giving lenalidomide and ibrutinib~     together with rituximab may work well in treating follicular lymphoma.~   "
132762|NCT01829555|"~     Glucose control is necessary to avoid the immediate and long-term adverse effects associated~     with type 1 diabetes, and frequent self-monitoring of blood glucose is the first important~     step to achieving glucose control. Data suggest that large proportions of adolescents and~     young adults fail to adhere to standard guidelines of self-monitored of blood glucose testing~     and have hemoglobin A1c levels >7.5%. A finite period of poor metabolic control can lead to~     increased risk of medical complications over an individual's lifespan, necessitating novel~     interventions to improve self-monitored blood glucose testing and metabolic control in~     emerging adults with type 1 diabetes. The investigators treatment approach, which provides~     direct tangible reinforcement for objective evidence of behavior change, is efficacious in~     decreasing substance use, reducing weight, and improving medication adherence.~      The purpose of this project is to develop and pilot test an intervention based on behavioral~     economic principles for improving self-monitored blood glucose testing in young persons with~     type 1 diabetes. In this pilot study, patients will text in, via cell phones, each time they~     test, and a return text will inform them of reinforcer vouchers earned. The investigators~     will collect data on self-monitored blood glucose testing frequency and A1c levels preceding~     treatment initiation and throughout a 6 month treatment period. If promising, a randomized~     trial will lead to larger scale evaluations of reinforcement interventions alone, or in~     combination with multimodal treatment approaches, and it may be applied to other clinical~     issues such as adherence to continuous glucose monitoring. Importantly, this intervention can~     be administered remotely and in an automated fashion, allowing for widespread adoption if~     efficacious.~   "
132763|NCT01829542|"~     The purpose of this study is to assess the impact of acute blueberry polyphenol intake on~     endothelial function of healthy volunteers. Specifically, the investigators plan to perform a~     randomised, double blind, cross-over human intervention trial using a blueberry drink to~     investigate the dose-dependent effects of blueberry polyphenols on blood vessel function~     using Flow mediated dilation (FMD) to measure endothelial function. The study will not only~     measure the acute effects of flavonoid ingestion on vascular reactivity but will also assess~     plasma polyphenol metabolite levels.~   "
132764|NCT01829529|"~     The hypothesis of the present study is that quantitative and qualitative oral microflora~     alterations and changes in antibiotic susceptibility among oral commensal microflora will~     occur following a single dose administration of amoxicillin.~   "
132765|NCT01829516|"~     This is a randomized, placebo controlled, double blind crossover study of the effects of~     intranasal oxytocin on social cognition, implicit preferences and craving in moderate to~     heavy social alcohol drinkers.~   "
132766|NCT01829503|"~     Primary objective: To determine the efficacy of an induction regimen using decitabine as an~     epigenetic primer followed by cytarabine in the treatment of older patients with newly~     diagnosed Acute myeloid leukemia (AML).~      Primary endpoint:~      Complete remission rates~      Secondary objective: To determine the safety of an induction regimen of decitabine followed~     by cytarabine in the treatment of older patients with newly diagnosed AML, evaluate survival~     and identify potential predictive factors for response to treatment~      Secondary endpoints:~        -  Treatment related toxicities~        -  4 and 8 week mortality~        -  Overall survival~        -  Relapse-free survival~        -  Predictive factors for response to treatment~        -  Quality of Life measures including self reported symptoms and assessment of sleep~          patterns~      Treatment administration~      Induction therapy Eligible patients will be treated with induction therapy (decitabine +~     cytarabine) at the University of Pittsburgh Cancer Center inpatient leukemia service at~     Shadyside Hospital. Patients will receive decitabine 20mg/m2 in 100mL normal saline (NS)~     intravenously (IV) over 1 hour daily for five days, followed by cytarabine 100mg/m2 in 1000~     mL normal saline (NS) as a continuous IV infusion over 24 hours for 5 days. Treatment should~     be discontinued or delayed for any of the following during the treatment period: a rise in~     serum creatinine > 2x patient baseline or upper limit of normal (whichever is higher) unless~     there is an identifiable reversible etiology, or ALT, AST or total bilirubin > 5x upper limit~     of normal, and should be held until resolution below these parameters. There are no~     parameters for dose reduction.~      Patients who have persistent disease on post-treatment bone marrow aspirate and biopsy, will~     undergo a repeat cycle of induction with decitabine followed by cytarabine as outlined above.~      Supportive care including blood product transfusions, antiemetic medications antiviral and~     antifungal medications, or empiric antibiotics may be used at the clinical discretion of the~     provider.~      Maintenance therapy Patients in complete response (CR) will proceed to decitabine maintenance~     therapy, where each treatment will be decitabine 20mg/m2 in 100mL normal saline (NS)~     intravenously (IV) over 1 hour daily for five days administered in the outpatient setting.~     Maintenance treatments will be continued until disease relapse. Maintenance treatments can be~     administered as an outpatient at the Hillman Cancer Center, or at a University of Pittsburgh~     Medical Center (UPMC) facility that is able to administer chemotherapy under the supervision~     of an Oncologist~      Evaluations during maintenance Phase:~      During maintenance therapy, complete blood count (CBC) w/ diff/platelets, CMP (Na, K, Cl,~     carbon dioxide (CO2), glucose, blood urea nitrogen (BUN), Cr, Ca, Total Protein, Albumin,~     AST, ALT, Alk Phos, Total Bilirubin) will be checked each cycle on day 14 [+/- 4 days].~      Within 7 days of start of new cycle, study visits will include physical exam, adverse events~     assessment, CBC and comprehensive metabolic panel (CMP).~      Maintenance cycles will be 28 days [+/- 7 days]. Cycles can be held up to 4 weeks [28 days].~     For start of new cycle, any grade 3 or 4 non-hematologic toxicity possibly, probably or~     definitely related to decitabine therapy must resolve to grade 2 or baseline.~      In addition the following lab parameters must be met to start a new cycle of maintenance:~      Absolute Neutrophil Count (ANC) > or = 1000/mm3 Platelets >/= 50,000/mm3 AST or ALT < 2 x~     Uppler Limit of Normal (ULN) Total billirubin < 2 x ULN Serum creatinine < 2x patient~     baseline or upper limit of normal (whichever is higher)~      [If lab parameters are not met for start of cycle, these labs will be checked a minimum of~     once per week]. If start of new cycle is held for more than 4 weeks [28 days], the subject~     will be off treatment.~      Other reasons for delay in treatment should be discussed with the Principal Investigator.~   "
132767|NCT01829490|"~     This is a Phase I trial to evaluate the safety and immunogenicity of a ChAdOx1 85A~     vaccination with and without MVA85A boost in healthy BCG vaccinated adults.~   "
132768|NCT01829477|"~     The purpose of this study is to evaluate the effect of TAK-875 compared to placebo on~     glycemic control over a 24-week Treatment Period when used as an add-on to glimepiride in~     addition to diet and exercise.~   "
132769|NCT01829464|"~     The purpose of this study is to evaluate the effect of TAK-875 (fasiglifam) in combination~     with sitagliptin on glycemic control in adults with type 2 diabetes.~   "
132770|NCT01829451|"~     The aim of the study is to evaluate if hyaluronic acid gel prevents intrauterine adhesion~     formation after endometrial thermal ablation.~   "
132771|NCT01829438|"~     To evaluate the effect of different distractive auditory stimuli (fast, slow and preferred)~     on 6 Minute Walking Test (6MWT) and the measured parameters (dyspnea, heart rate, oxygen~     saturation) in healthy children.~   "
132772|NCT01829425|"~     This study is randomized controlled trial in which urgency incontinent women (approximately~     150-160) will be randomized to hypnotherapy or pharmacotherapy and evaluated at months 2, 6~     &12; a subset of women will have pre-treatment brain activation and connectivity compared to~     controls using functional magnetic imaging (fMRI) with 2 month post-treatment brain~     activation and connectivity compared to pre-treatment in the UUI subset using fMRI.~      Hypotheses: Among patients with urgency urinary incontinence (UUI), hypnotherapy decreases~     abnormal perception of bladder distension outside the hypnotic state and is at least as~     effective as pharmacotherapy in diminishing symptoms of urgency and severity of UUI. On fMRI~     in UUI, hypnotherapy will decrease hyper-activation of brain areas in response to bladder~     distension and/or modulate functional connectivity within the brain. Normalization of~     hyper-activation and connectivity will be greater in hypnotherapy compared to~     pharmacotherapy. Additionally, women who have greater improvement in UUI will have greater~     normalization of hyper-activation and connectivity on fMRI. UUI participants will exhibit~     increased activation within portions of the brain and abnormal functional connectivity~     relative to controls.~   "
132773|NCT01829412|"~     Bone disease in multiple myeloma (MM) is routinely assessed by skeletal X-ray (XR) and~     magnetic resonance of the spine (S-MRI). Diffusion-weighted MRI (DW-MRI) is a functional MRI~     that detects water diffusion through cells. This prospective phase II study compared~     whole-body DW-MRI with XR and S-MRI for the assessment of MM bone lesions.~      METHODS. Thirty-six consecutive symptomatic patients at diagnosis or at relapse performed XR,~     S-MRI, whole-body MRI, and whole-body DW-MRI before treatment, after treatment, and 6 months~     after treatment. A substudy evaluated 12 asymptomatic patients at diagnosis, after 6 and 12~     months. Radiology exams were independently read by 3 experienced radiologists, and the~     techniques were compared by the count of segments with focal lesions (FL) (>=5mm).~   "
132888|NCT01827904|"~     The objective of this prospective, randomized, double-blind (to subjects, local site's~     blinded assessor and Tremor Core Lab assessors), crossover, multi-site, two-arm study~     (ExAblate treated arm Vs ExAblate Sham treated control arm) is to test the efficacy of~     treatment using the ExAblate Transcranial System and to further demonstrate safety in~     medication-refractory tremor in subjects with essential tremor (ET).~   "
132774|NCT01829399|"~     Purpose: Even with excellent regional anesthesia of the upper extremity, tourniquet (Tq) pain~     from an upper arm Tq can limit the ability to use regional anesthesia as the primary~     anesthetic for surgical procedures on the upper extremity. The aim of this study is to~     determine whether a subcutaneous ring of local anesthetic on the inner aspect of the upper~     arm just distal to axillary crease will significantly diminish Tq pain. If it does,~     peripheral nerve blocks distal to the Tq (i.e., nerve blocks at the elbow) could be used as~     the primary anesthetic for surgery of the hand and forearm. These distal peripheral nerve~     blocks have fewer complications than brachial plexus blocks performed at higher levels, and,~     postoperatively, the patient has better control of his or her arm when distal nerve blocks~     are used.~      Procedures (methods): This is a prospective, cross-over study to examine the effectiveness of~     an upper arm Subcutaneous ring of local anesthetic alone in relieving Tq pain. This~     Subcutaneous ring of local anesthetic is often referred to as Intercostobrachial nerve~     block or Subcutaneous ring anesthesia (SRA). Twenty volunteers will be randomized into~     four groups of 5 participants each. During the initial experiment, the first group will be~     given SRA with 10-15 mL of 0.25% Bupivacaine with Epinephrine 1:200,000 on their dominant~     arm, the second group will be given SRA with 10-15 mL of 0.25% Bupivacaine with Epinephrine~     1:200,000 on their non-dominant arm, the third group will be given sham SRA with saline on~     their dominant arm, and the fourth group will be given sham SRA with saline on their~     non-dominant arm. 15 minutes after SRA, a Tq will be applied to the arm with the subcutaneous~     injection and it will be inflated to 100 mm Hg above the subject's baseline systolic blood~     pressure. We will monitor heart rate, blood pressure (opposite arm) and pain (0 to 10 VAS)~     every 5 minutes. Each Tq will be released when the subject requests deflation or when 1 hour~     of Tq time has elapsed, whichever occurs first. The subject's discomfort level (VAS) just~     prior to deflation will be recorded. Since Tq pressure alone can inhibit nerve function, we~     will monitor motor and sensory function distal to the Tq every 10 minutes during Tq inflation~     and for 30 minutes after Tq deflation. One to two weeks after this initial study, the same 20~     subjects will receive SRA on the same arm and the same parameters will be measured. The 10~     subjects who received 0.25% Bupivacaine the first time will receive Normal Saline, and the 10~     subjects who received Normal Saline the first time will receive 0.25% Bupivacaine. In this~     way, each subject will act as his or her own control.~   "
132775|NCT01829386|"~     This study will determine if MRI imaging can be used to estimate the amount of iron in areas~     of the brain affected by a stroke. This may help future patients if the scan can be used to~     predict the amount of brain damage and therefore the effects on the patient.~      New research treatments are being used to reduce the amount of iron build-up in the brain.~     The effects of that treatment may also be estimated using new MRI techniques.~   "
132776|NCT01829373|"~     This study tests the ability of the allogeneic cellular vaccine 1650-G vaccine to enhance~     immune recognition of tumor cells in patients with lung cancer. The vaccine is combined with~     an oral medication called beta glucan, an over the counter oral dietary supplement that may~     also stimulate the immune system in ways that helps the body eradicate cancer cells and~     reduce risk of recurrent cancer. The primary purpose of this study is to measure the changes~     in the number of immune cells that might help lower risk of cancer recurrence. The~     investigators do not yet know if the vaccine is effective in fighting cancer and will not~     know at the end of this study whether this has been of benefit.~   "
132777|NCT01829360|"~     This research attempts to adapt and optimize a word learning treatment, specifically~     interactive book reading, for use with Kindergarten children with Specific Language~     Impairment (SLI). Children with SLI have difficulty learning language without any obvious~     cause for this difficulty. Two treatment studies will be conducted to determine (1) the~     number of times children with SLI need to hear new words during book reading to learn the new~     words; (2) the best way to provide the target number of exposures to new words during book~     reading. For example, is it better to hear the new words many times within the book and to~     read the book few times, or is it better to hear the new words a few times within the book~     and to read the book many times. The investigators hypothesize that children with SLI will~     need to hear new words 2 to 3 times as often as children with normal language to learn the~     words and that reading the books many times will be more effective than repeating the words~     many times within a book.~   "
132778|NCT01829347|"~     The purpose of this study is to determine if treatment with the ELAD System is safe and~     effective in subjects with severe acute alcoholic hepatitis and Lille score failures (Lille~     score >0.45).~   "
132779|NCT01829334|"~     The aim of this proposed study is to investigate the cost-effectiveness of four methods in~     preventing fissure caries in permanent teeth, which is the most prevalent dental disease in~     primary school children in China.~      The four caries prevention methods are: resin fissure sealant, atraumatic restorative~     treatment (ART) sealant, sodium fluoride varnish, and silver diamine fluoride (SDF) solution.~      The specific study objectives are:~        1. to describe longitudinally the clinical outcomes of using the above four methods to~          prevent dental caries in the pits and fissures of permanent first molars in school~          children,~        2. to describe the cost of using the above four methods to prevent dental caries in an~          outreaching dental care programme in China, and~        3. to compare the cost-effectiveness of the above four caries prevention methods.~   "
132780|NCT01829321|"~     -  Approximately 45 patients suffering from mild to moderate ulcerative colitis will be~          examined for any side effects (safety and tolerability) that may occur when taking~          GLPG0974 or matching placebo (2:1 ratio) for 28 days.~        -  During the course of the study, patients will also be evaluated for improvement of~          disease activity by different efficacy measures, the amount of GLPG0974 present in the~          blood determined (PK) and the effects of GLPG0974 on selected biomarkers (PD) in the~          blood, colon biopsies and faeces will be explored.~   "
132781|NCT01829308|"~     The purpose of this study is to examine the implementation of two evidence-based intervention~     strategies of SBIRT (Generalist vs. Specialist) for adolescent alcohol, tobacco, other drug~     use, and HIV risk behaviors.~   "
132782|NCT01829295|"~     In the First-line Antimetabolites as Steroid-sparing Treatment (FAST) Uveitis Trial, the~     investigators propose to establish which immunosuppressive therapy, methotrexate or~     mycophenolate mofetil, is more effective as a first-line, corticosteroid-sparing agent for~     the treatment of non-infectious uveitis in a block-randomized, observer-masked, comparative~     effectiveness trial.~   "
132818|NCT01828827|"~     This is a Phase 1, single-center, randomized, balanced, single-dose, two-treatment,~     two-period, two-sequence, crossover, open-label study to evaluate the effect of food on the~     pharmacokinetics of PA-824. This study was designed to understand the possible effects of a~     high-calorie, high-fat meal on PA-824 absorption and pharmacokinetics. The hypothesis to be~     tested in this study is that the rate and extent of absorption of PA-824, as measured by~     Tmax, Cmax, AUC(0-t), and AUC(0 inf), are the same after a high-calorie, high-fat meal as~     compared with after a minimum 10-hour fast.~   "
132819|NCT01828814|"~     Options for large-scale preventive distributions include fortified blended flours,~     ready-to-use foods and direct cash transfer either alone or in combination with family~     protective rations. Finding the most appropriate strategy is essential to prevent child~     malnutrition in countries like Niger with annual hunger gaps. Here, the investigators compare~     different preventive strategies on the incidence of acute malnutrition among children 6 to 23~     months.~   "
132783|NCT01829282|"~     This study focuses on the implementation of an evidence-based HIV risk reduction intervention~     for HIV-serodiscordant, heterosexual African American couples (Eban II) in two geographic~     areas (Northern and Southern California - roughly, Alameda and Los Angeles Counties) that~     have a high prevalence of HIV infection and risk conditions among African Americans.~      The Specific Aims are as follows:~        1. To evaluate implementation of Eban for HIV serodiscordant African American couples in 10~          CBOs in California. To do this, we will document the implementation process and identify~          barriers and facilitators to Eban's adoption and use by the CBOs. We will interview 200~          staff at CBOs to obtain this information.~        2. To evaluate the effect of Eban on behavioral and biological outcomes among 180 couples,~          specifically incidents of protected sex, proportion of condom use, and incident sexually~          transmitted infections. Eban will be assessed using a randomized delayed enrollment~          (waitlist) control design to evaluate the impact of treatment on outcomes at posttest~          and 3-month follow-up (i.e., at these 10 CBOs, Eban will be conducted and offered to~          couples and evaluated for effectiveness - that is, how well it works in the real world.)~        3. To determine the cost-effectiveness of implementation of Eban, based on implementation~          costs and potential cost savings.~   "
132784|NCT01829269|"~     The average survival rate of a defibrillation lead is 91 to 99% at 2 years, 85-95% at 5 years~     and 60-72% at 8 years. We must also manage alerts for defibrillation probes with a higher~     complication rate than average. We will therefore be increasingly confronted with faulty~     sensors or at risk to be replaced.~      There are no standardized approach for replacing defibrillation lead. A record made in the~     United States showed significant differences according to the teams strategy in case of~     failure of defibrillation lead in particular with regard to the decision to explant or~     abandon the probe.~      The risk of extracting a defibrillation lead are well known with a major complication rate of~     1.6 to 1.95%.~      Regarding the risk of complications related to the abandonment of a probe we have less data.~     For some there is no risk to abandon a defibrillation lead. But others reported a~     complication rate of 5.5% related to pacing discontinued.~      Main objective: Collect the attitude of different centers and different operators when~     replacing a failed defibrillation lead or at risk. Explantation or abandonment of the~     sensor replaced.~   "
132785|NCT01829256|"~     Diabetic kidney disease (DKD) is associated with high rates of cardiovascular events and~     death. In addition, DKD is the major cause of end-stage renal disease (ESRD) in the United~     States. The purpose of this study is to prevent progression of kidney disease among patients~     with DKD and uncontrolled hypertension (HTN) using a tailored, telehealth intervention that~     simultaneously address medication management and modifies multiple risk factors through a~     combination of patient self-monitoring, behavioral therapies and education to optimize~     adherence and self-efficacy. Additional goals are to improve control of cardiovascular~     disease risk factors and reduce cardiovascular events and death.~      We hypothesize that patients with DKD and uncontrolled HTN who receive this intervention will~     have less progression, or a smaller decrease in kidney function, after 3 years when compared~     to the education control group.~   "
132786|NCT01829243|"~     This study was designed to investigate whether milnacipran is safe and effective in improving~     cognitive function in fibromyalgia. In addition, this study was aimed to investigate whether~     improvement in neurocognitive status due to milnacipran correlates with improvements in pain,~     to investigate whether improvement in neurocognitive status due to milnacipran correlates~     with improvements in fatigue, and to determine whether treatment with improvement in~     neurocognitive status, pain and fatigue correlates with functional improvement.~   "
132787|NCT01829230|"~     This is a continuation study for subjects who were previously fit with test or control~     lenses; all will stop wearing their study lenses assigned in the previous study and will~     start to wear an FDA-approved marketed spherical soft contact lens.~   "
132788|NCT01829217|"~     This research study is a Phase II clinical trial, which tests the safety and effectiveness of~     an investigational drug to learn whether the drug works in treating a specific cancer.~     Investigational means that the drug is being studied. It also means that the FDA has not~     yet approved sunitinib for your type of cancer.~      Sunitinib has been approved by the FDA for treatment of gastrointestinal stromal tumors,~     advanced renal cell carcinoma and advanced pancreatic neuroendocrine tumors. While most~     chemotherapies work by interfering with cancer cell replication, sunitinib works by blocking~     certain protein signals within the cell. Because sunitinib works differently from standard~     intravenous chemotherapies, we call it a targeted therapy. This drug has also been used in~     other research studies and information from those other research studies suggests that this~     agent may help to slow the growth of some NSCLC tumors.~      In this research study, we are looking to see if sunitinib may stop certain NSCLC tumors from~     growing. The study focuses on a type of NSCLC, adenocarcinoma, which has previously been~     found to be more sensitive to other kinds of oral targeted therapies. This study will focus~     specifically on (1) adenocarcinoma tumors that do not carry a mutation in a known cancer gene~     (EGFR, KRAS, or ALK) and occur in patients that never smoked (less than 100 cigarettes in~     their lifetime) or (2) adenocarcinoma tumors that have a mutation in the RET gene.~   "
132789|NCT01829204|"~     The purpose of this study is to identify and elucidate the pattern and perhaps role of~     atypical proteins, cytokines and vaginal microbial flora in the pathogenic mechanisms~     involved in the development of vulvodynia, recurrent fungal and bacterial vaginosis and~     preterm labor.~   "
132790|NCT01829191|"~     This study is to investigate whether novel soft contact lens optical designs can slow myopia~     progression~   "
132820|NCT01828801|"~     The purpose of this clinical study is to evaluate blood metal ion levels as a function of~     time of implantation for the Pinnacle Acetabular MoM system.~   "
132821|NCT01828788|"~     Postoperative pain after cardiac surgery is a risk factor for postoperative complications. In~     cardiac surgery, pain is more intense during the first 48 hours and disturbs the patient's~     capacity of coughing, deep breathing, and early mobilisation. It may be responsible for~     respiratory complications such as bronchial or pulmonary infection, and may also delay the~     patient's rehabilitation and therefore prolong the duration of in-hospital stay. A previous~     pilot study performed in our department showed a sensible improvement of analgesia at~     movement and of rehabilitation with a continuous bilaterosternal infusion of local~     anaesthesia [Eljezi et al.. Reg Anesth Pain Med 2012; 37:166]. Such strategy shall be tested~     in a subpopulation of patients at risk for respiratory complication.~   "
132791|NCT01829178|"~     Cisplatin is a potent chemotherapeutic agent that has been widely used to treat many solid~     tumours. acute renal failure, despite conservative fluid and electrolyte management,~     frequently reported adverse event and limiting cisplatin use. Silymarin, a flavonolignan~     complex isolated from Silybum marianum, has a strong antioxidant, hepatoprotective,~     anticancer and in animal model nephroprotective properties. Neutrophil gelatinase-associated~     lipocalin (NGAL) protein is a promising biomarker to detect acute kidney injury due to~     cisplatin. Milk thistle extract inhibitory effects on epidermal growth factor receptor,~     vascular endothelial growth factor and insulin-like growth factor-I have shown in the~     previous in-vitro studies.The aim of present study,a randomized double-blind placebo-~     controlled clinical trial, to investigate the therapeutic effect of silymarin on cisplatin~     induced nephrotoxicity and it's impact on chemotherapy. Fifty-eight patients with diagnosed~     upper gastrointestinal tract carcinomas randomized to silymarin (420mg) or placebo plus~     chemotherapy [cisplatin 50-60 mg/m2, 5-fluorouracil mg/m2, docetaxel 60-80 mg/m2 every 21~     days] for 63 day after inclusion. serum creatinin, blood urea nitrogen (BUN), serum and urine~     electrolyte will be measured daily during chemotherapy.~      changes in urine NGAL, serum vascular endothelial growth factor (VEGF)and caspase activity~     assessed up to 64 days.~   "
132792|NCT01829165|"~     The overarching goal of this research program is to elucidate causal and directional neural~     network- level abnormalities in depression, and how they are modulated by an~     individually-tailored, circuit-directed intervention. By using concurrent TMS and fMRI, the~     investigators can overcome a major limitation of neuroimaging - the inability to demonstrate~     causality. The investigators' findings will serve as a platform for future studies wherein~     TMS treatment can be directly guided by the investigators' ability to image and causally~     manipulate specific neural networks.~      Aim 1: To examine causal interactions between two major brain networks in depression.~      Aim 2: To examine the impact of antidepressant TMS on causal network abnormalities in~     depression.~      Hypothesis 1: Depressed subjects will show blunted responses, compared to healthy controls,~     in two targeted and interacting networks, using concurrent transcranial magnetic stimulation~     (TMS) and functional magnetic resonance imaging (fMRI).~      Hypothesis 2: Treatment of patients with high-frequency repetitive TMS (rTMS) will result in~     normalization of baseline network-level deficits, and be predicted by degree of baseline~     network abnormalities.~   "
132793|NCT01829152|"~     The primary objective is to evaluate the impact on heart failure related quality of life when~     integrating a mobile health system, Verizon Wireless's Converged Health Management (CHM),~     into a subject's self-management of their heart failure (HF) as well as in the medical~     management of HF by the subjects' clinical team.~   "
132794|NCT01829139|"~     In patients with gallbladder in situ after complete removal of common bile duct (CBD) stones,~     there is no definite guideline for the management of remnant acalculous gallbladder. This~     study was planned to evaluate the efficacy of choleretic agents in those patients comparing~     with non-treatment group during short (2 years) and long-term (5 to 10 years) period. So~     that, the investigators want to establish the treatment guideline in gallbladder in situ~     without definite stones following complete removal of CBD stones. Second, the protective or~     preventive effect of choleretics may be defined.~   "
132795|NCT01829126|"~     Systemic sclerosis is an orphan, multiorgan disease affecting the connective tissue of the~     skin and all internal organs. Cardiac involvement, mainly characterised by small~     intramyocardial coronary artery involvement and myocardial fibrosis, can cause the~     development of impaired diastolic ventricular filling, cardiac blocks and ventricular~     arrhythmias, and can ensue in congestive heart failure and sudden death. Until now, no drug~     has been proven to have a therapeutic effect on SSc myocardial disease on an evidence-based~     level. Short-term trials and retrospective studies have suggested a favourable and protective~     effect of calcium channel blockers and angiotensin converting enzyme inhibitors in patients~     with myocardial involvement. However, no data are presently available on the prevention and~     treatment of severe heart disease.~      This observational trial is part of the collaborative project DeSScipher, one out of five~     observational trials to decipher the optimal management of systemic sclerosis. Aim of this~     observational trial is to assess the efficacy and safety of calcium channel blockers and~     angiotensin converting enzyme inhibitors in asymptomatic SSc patients with cardiac~     involvement.~   "
132796|NCT01829113|"~     This randomized phase II study will compare the efficacy and safety of the combination of~     carboplatin and pemetrexed with and without OGX-427 in patients with previously untreated~     advanced non-squamous NSCLC.~   "
132797|NCT01829100|"~     Psychological therapies for depression have demonstrated efficacy, but outcomes are still~     unsatisfactory, especially in cases with high comorbidity. Depression and anxiety co-occur in~     up to 69-75% of teens and intensify functional impairment and service use. This study will~     develop treatment materials for a transdiagnostic Group Behavioral Activation Therapy (GBAT)~     and conduct a pilot waitlist-controlled school-based study with 35 7th and 8th grade boys and~     girls with co-occurring depression and anxiety. Multi-reporter, multi-domain assessments will~     be conducted at initial screening, pre- and post-treatment, and 4-month follow-up. BA is a~     straightforward, but flexible and robust, therapy that has demonstrated strong results in~     adults. Current formulations of BA highlight the specific role of avoidance in depressotypic~     behavior. It presumes that anhedonia, isolation, and negative behaviors associated with~     depression function to avoid imminent distress even as it blocks access to otherwise~     available positive reinforcement. This study will therefore employ novel electronic diary~     technology to obtain Ecological Momentary Assessment and evaluate: (a) the function of~     avoidance in distinguishing youth with depression (n=35) from a non-clinical comparison group~     (n=18), and (b) the role of avoidance in mediating treatment gains in participants in the~     GBAT intervention.~   "
132798|NCT01829087|"~     The goal of this research project is to evaluate injections of botulinum toxin A (Botox) as~     the treatment for knee flexion contracture after total knee arthroplasty (TKA). The current~     treatment for patients who do not achieve full extension of the knee (flexion contracture)~     after TKA consists of an aggressive physical therapy program, home stretching program, and~     the use of an extension orthosis (brace). Many patients do not tolerate wearing these braces.~     This initial project is designed to use injections of Botox as an adjunct to the standard~     current treatment and evaluate its efficacy. It is our hypothesis that a single injection~     into the hamstrings in addition to routine postoperative rehabilitation will result in~     improved knee extension and this improvement in function should endure without further~     treatment.~   "
132799|NCT01829074|"~     Acid reflux can cause many symptoms in the throat, including discomfort or pain, and~     difficulty with breathing and voice problems. Doctors have different ways of diagnosing and~     treating the reflux that causes these symptoms, and they are trying to better understand what~     the best ways are to treat the patients with these symptoms.~      Usually, a doctor will prescribe medication for reflux based on the symptoms a patient~     complains of. Sometimes it works and the patient gets better, sometimes it does not work and~     the patient's condition does not improve. The doctor will also use findings from an~     examination with an endoscope in the patient's throat to see if there is any damage that~     might have been caused by reflux. One new device that doctors use to help them diagnose~     reflux has a sensor on the end of a tube that goes through the nose and rests in the throat.~     This sensor measures the acid reflux for 24 hours, showing the doctor when acid reflux~     occurs.~      The study doctors are performing this research study to help them understand more about acid~     reflux disease, and the best ways to diagnose and treat their patients who have acid reflux.~      The study involves procedures, medications and devices that are already used regularly in~     doctors' offices and hospitals. The experimental part of this research is blinding the study~     doctor to the results of the pH study until the end of a three month course of antireflux~     medication, and performing a second pH study to measure change in acid exposure.~      Hypothesis: The Restech pH study helps identify patients who will respond positively to acid~     inhibitory therapy, and patients whose study normalizes will have better Symptomatic response~     rates than those whose pH levels fail to normalize.~   "
132800|NCT01829061|"~     The Quo-Test A1C Analyzer and Reagent Test System (Quo-Test A1C System) are intended for the~     in-vitro quantitative determination of glycated hemoglobin in whole blood samples obtained~     from fingerstick or venous samples for point-of-care testing. The Quo-Test A1C System is~     indicated in the management and treatment of diabetes and for monitoring long term glycemic~     control by diabetics. It is for multiple patient use. Only auto-disabling, single use lancing~     devices should be used with this system.~   "
132801|NCT01829048|"~     To evaluate the safety and tolerability of multiple doses of PF 02545920 administered orally~     to psychiatrically stable subjects with schizophrenia receiving background antipsychotic +/-~     other adjunctive medication.~   "
132802|NCT01829035|"~     This is a randomized, multi-center, open-labeled, phase III study in patients with advanced~     HCC. A total of 338 patients will be randomized (1:1) into one of the two treatment arms, to~     receive sorafenib with (Arm Combination-treatment; Arm C) or without (Arm Sorafenib alone~     treatment; Arm S) cTACE.~      All the patients will be initially given sorafenib within 72 hours after the randomization.~     Treatment should continue until the criteria for treatment discontinuation are met.~      After the treatment period, patients will undergo follow up for survival every 12 weeks (±7~     days) from the last dose, and the survival follow up will be performed for at least 1.5 years~     after the last patient's last treatment.~   "
132803|NCT01829022|"~     Primary objectives : To investigate technical feasibility and postoperative morbidity after~     E-NOTES for Myomectomy with Traction of Multidirectional Sutures~      Secondary objectives : To investigate postoperative pain after E-NOTES for Myomectomy with~     Traction of Multidirectional Sutures by clinical variables such as incision size, type of~     port, size and number of myoma, or operation time.~   "
132804|NCT01829009|"~     Aging is characterized by a progressive loss of multiple physical and cognitive abilities.~     From these changes, the most important one is the loss of muscle mass, which has been called~     sarcopenia. Resistance exercise is a therapeutic approach for sarcopenia, nevertheless~     there is no universal consensus. Therefore, this research is interested in determining the~     effect of a resistance exercise program on physical performance and/or functional status in~     sarcopenic older women. The main study hypothesis is that a program of resistance exercise~     will improve physical performance and functional status in sarcopenic older women compared~     against general recommendations.~      This is a single-blind, controlled clinical trial, including women> 70 years, living in the~     community with sarcopenia. Those who agree to participate, will be randomly assigned to one~     of the following groups:~        1. Resistance Exercise Group~        2. General Recommendations Group (control) The study will last 24 weeks, with 4~          measurements performed at baseline, week 6, 12 and 24. Multilevel models (random~          effects) will be constructed for the comparison between the two groups. Tests will be~          conducted with a P=0.05 and confidence intervals at 95%. This protocol has been approved~          by the local ethics committee.~   "
132805|NCT01828996|"~     Chronic prostatitis/chronic pelvic pain syndrome is an extremely common urologic diagnosis~     and accounts for approximately 2 million outpatient visits to urology practices in the United~     States alone. Up to 6% of men in Canada recently experienced at least moderate to severe~     prostatitis-like symptoms with two thirds having symptoms lasting more than one year. There~     are a myriad of therapies for prostatitis, some of which work on some of the men but none~     works for all the men. Recently, a number of centres have been using low energy shock waves~     applied on the skin to target the prostate and the muscles around the prostate. The initial~     reports showed a significant reduction in the pain experienced by the men with prostatitis.~     However, this potentially highly promising therapy has not been widely used at least in part~     due to a lack of properly designed studies to validate this therapy. The investigators plan a~     randomized control trial using shock wave therapy on men with prostatitis. The goal is to~     provide some solid evidence that either shock waves are or are not of clinical benefit.~      The investigators hypothesize men with chronic prostatitis/ chronic pelvic pain syndrome will~     have a reduction in pain and improved voiding and sexual function following low power~     transdermal shock wave therapy to the prostate and surrounding pelvic muscles.~   "
132822|NCT01828775|"~     This pilot randomized clinical trial studies palliative care intervention in improving~     quality of life, psychological distress, and communication in patients with solid tumors~     receiving treatment on phase I trials. Cancer patients experience many symptoms related to~     treatment and the cancer itself that can be distressing and impact quality of life.~     Palliative care focuses on managing these symptoms and may help patients with solid tumors~     live more comfortably.~   "
132889|NCT01827891|"~     This single-center, randomized controlled trial is to investigate the impact of remote~     ischemic preconditioning (RIPC) on the risk contrast-induced acute kidney injury and its~     long-term impact on renal function for patients with diabetes undergoing percutaneous~     coronary intervention.~   "
132806|NCT01828983|"~     Deployment impacts both service member and family, and the cost can be high. Spouses'~     reactions to deployment may include emotional distress, loneliness, anticipatory fear or~     grief, somatic complaints, and depression. The goal is to help spouses learn ways to manage~     stress and solve problems related to deployment and reintegration, communication, managing~     long distance relationships, and other common problems. The study will compare telephone~     support groups to online education sessions. The study will enroll 160 spouses. In the~     Telephone Support groups, a group leader and participants will meet 12 times over six months~     to focus on education, skills building and support. Education Only online sessions will~     provide the same education content, without skills building or support. Content includes~     strategies to reduce or eliminate communication difficulties during deployment, how to find~     help; practical concerns during deployment; fostering resilience and decreasing stress;~     fostering relationships while apart, negotiating roles and relationships; changes during~     deployment; strategies to support the spouse and the service member; and cues to alert~     spouses when to seek mental health services for the family or themselves. Outcomes will~     include resilience, depression, anxiety and coping behaviors. Telephone data collection will~     be conducted at baseline, six and twelve months.~   "
132807|NCT01828970|"~     The purpose of the study is to evaluate the effect of the basal-bolus detemir-aspart insulin~     regimen coupled with continuous glucose monitoring (CGM) on glycemic control in hemodialyzed~     patients with diabetes~   "
132808|NCT01828957|"~     The objective of this study is to evaluate the efficacy and safety of a single intratracheal~     administration of Pneumostem® for treatment of Bronchopulmonary Dysplasia (BPD) in high-risk~     premature infants by comparing Pneumostem-treated group with a control group.~   "
132809|NCT01828944|"~     The present project hypothesizes that the potential protective effect of olive oil relies on~     its polyphenols profile (quality and quantity) and that it may be synergistic to other food~     components. Among the nutrients that may be of interest for bone and muscle tissues,~     unsaturated fatty acids and vitamins are the most described.~      Consequently, based on the promising available preliminary data, the present project aims to~     investigate the possible preventive effect of olive oil polyphenols and eventually the~     synergistic effects of fatty acids and vitamin D on bone, muscle and adipose tissue, in order~     to prevent any locomotor dysfunction.~      Volunteers will be supplemented during 9 months. The primary and secondary outcome measures~     will be performed at baseline, 3 and 9 months.~   "
132810|NCT01828931|"~     The rate of type-2 diabetes mellitus (T2DM) is at least 2-3 times higher in persons with~     psychotic illnesses than in the general population. Life expectancy of individuals with~     psychosis is also 20-25 years less than the general population, primarily due to premature~     onset of cardiovascular disease (CVD). Despite the high risk for T2DM and CVD, psychotic~     illness has been an exclusion criterion in all large-scale studies of diabetes prevention and~     management. We propose a 3-year randomized controlled trial examining the effectiveness of a~     lifestyle intervention (LI) aimed at reducing caloric intake and increasing physical activity~     in overweight or obese individuals (N=150) suffering from both a psychotic illness and T2DM.~     Weight and glycemic control will be the primary outcome variables. It is hypothesized that a~     significant weight reduction and improvement in glycemic control will be found in those who~     receive the LI relative to those who do not.~   "
132811|NCT01828918|"~     Recent basic and clinical research on the circulating tumor cells (CTCs) in CRC patients~     takes potential diagnostics, prognostics, and applications into consideration, especially the~     molecular detection of CTCs in peripheral blood. Moreover, identification of therapeutic~     targets on CTCs and real-time monitoring of CTCs in cancer patients undergoing systemic~     therapy are the most important future clinical applications. CTCs measures may be useful to~     guide change in treatment decisions.~   "
132812|NCT01828905|"~     The aim of the study is to compare fracture healing, quality of life, pain, and cost of care~     of the use of CERAMENT™|BONE VOID FILLER as bone graft substitute to the use of autologous~     cancellous bone graft (iliac crest) in the treatment of patients with tibia fractures treated~     by internal fixation and void reconstruction.~   "
132813|NCT01828892|"~     Adjuvant use of fibrin glue (FG) in the fistula tract has been shown to promote closure of~     low-output enterocutaneous fistulas (ECFs). The primary objectives of this study are to~     compare the clinical efficacy, safety of autologous platelet-rich fibrin glue (PRFG),~     commercial fibrin glue, and control therapy in the management of patients with low-output~     volume ECFs.~   "
132814|NCT01828879|"~     The purpose of this study is to evaluate the safety and efficacy of tacrolimus ointment in~     treating the signs and symptoms of moderate (medium level of seriousness) to severe (very~     serious, life threatening) atopic dermatitis (an intensely pruritic [itching], chronic~     [lasting a long time], inflammatory [pain and swelling], immunologically based skin disease~     with a genetic predisposition [latent susceptibility to disease at the genetic level]) in~     adult participants.~   "
132815|NCT01828866|"~     One interesting approach to the treatment of addiction is the use of Eye Movement~     Desensitization and Reprocessing (EMDR) (Shapiro, 1989). Although research on the feasibility~     and efficacy of EMDR on addiction is limited and often lacks methodological rigor, the~     results are promising and suggest that further research on this subject is warranted.~      This proposal consists of two studies to test and determine the acceptability, feasibility~     and efficacy of EMDR as an intervention to reduce craving and alcohol use in alcohol~     dependent outpatients as well as to gain further understanding in underlying working~     mechanisms.~   "
132816|NCT01828853|"~     This study aim to estimate maternal and neonatal outcomes after membrane sweeping in~     different group of patients.~   "
132817|NCT01828840|"~     The current study aim is to compare between the opioids morphine, fentanyl and methadone in~     terms of efficacy and side effects profile when administered epidurally for pain management~     after laparotomies. Intravenous morphine will also be used. The outcomes of that method will~     be compared to those obtained using epidurally administered opioids, as this is another~     commonly used postoperative pain relief method.~   "
132823|NCT01828762|"~     Although liver resection, liver transplantation, a-interferon, Transarterial Chemo~     Embolization (TACE), percutaneous ethanol injection (PEI), Percutaneous microwave coagulation~     therapy (PMCT), Radiofrequency ablation (RFA) provide options to treat patients with HCC, the~     high recurrence rate of mid-late stage liver cancer still exists. The safety of autologous~     Immune Cell Therapy in Primary Hepatocellular Carcinoma (HCC) Patients Following Resection~     and TACE Therapy will be evaluated.~   "
132824|NCT01828749|"~     Abdominopelvic CT (CTap) utilization rose significantly in blunt trauma patients over the~     last decade. However, the observed increases failed to reduce mortality or missed injury~     rates. Several investigators have derived (citation) and validated (citation) clinical~     decision rules that attempt to identify a subset of low risk pediatric and adult patients in~     whom abdominopelvic CT imaging can be safely eliminated. Thus far these efforts failed to~     significantly reduce utilization. The investigators propose an alternative and complimentary~     strategy to decrease radiation by selectively eliminating the pelvic imaging portion of the~     abdominopelvic CT in low risk patients. In stable, alert patients without clinically evidence~     of pelvis or hip fractures, abdominal CT imaging alone (diaphragm to iliac crest) identifies~     clinically significant intra-abdominal injury (cs-IAI) as accurately as routine~     abdominopelvic imaging (diaphragm to greater trochanter) and results in a clinically~     important decrease in radiation exposure. The study will investigate this by comparing the~     accuracy of an imaging protocol using CT abdomen alone versus CT abdomen and pelvis to detect~     cs-IAI among stable, blunt trauma patients without suspected pelvis or hip fractures in two~     age groups: ages 3-17 years and 18-60. Patients will undergo CT imaging as deemed clinically~     indicated by the treating clinician. Among those who have abdominopelvic CT scans, the study~     will determine the test characteristics of CT abdomen alone versus CT abdomen plus CT pelvis~     imaging for the identification of cs-IAI. The reference standard will include initial~     radiology reports, with structured follow up of indeterminate scans, operative reports, and~     7-day medical record review.~   "
132825|NCT01828736|"~     A multicenter, randomized, Phase 2 trial to study the effectiveness and feasibility of~     association of trastuzumab with combination chemotherapy in advanced or metastatic bladder~     cancer patients. Combining monoclonal antibody therapy with combination chemotherapy may~     improve treatment efficacy on tumours overexpressed HER 2.~   "
132826|NCT01828723|"~     The primary purpose of this study is to demonstrate the safety of injecting the Stromal~     Vascular Fraction (SVF) [containing Adipose Derived Stem Cells (ADSCs)] enriched fat grafts~     into regions of the face that require enhancement. The safety of SVF will be evaluated~     throughout the course of the study phase through the assessment of laboratory values,~     physical examinations, adverse events, safety phone calls etc.~   "
132827|NCT01828710|"~     Many clinical evidences suggest that Myo-inositol plays a crucial role in human reproduction.~     Also, it was shown that Myo-inositol concentration in the seminiferous tubules was higher~     than in serum, and interestingly it was increasing through the epididymis and the deferent~     duct mining that sperm cell before ejaculation are stored in a medium highly enriched in~     myo-inositol.~      Starting from this evidences, the investigators hypothesized that myo-inositol may be a~     possible factor able to improve the semen parameters of samples used in in vitro~     fertilization cycles.~   "
132828|NCT01828697|"~     This is a randomized-controlled open-label trial comparing two different doses of~     low-molecular-weight heparin (LMWH) in pregnant patients with a history of previous venous~     thromboembolism (VTE). Both doses are recommended doses in the 2012 guidelines of the~     American College of Chest Physicians (ACCP), but it is not known which dose is more~     efficacious in preventing recurrent venous thromboembolism in pregnancy.~      Patients enter the study and will be randomized as soon as a home test confirms pregnancy.~     LMWH will be administered until 6 weeks postpartum. Follow-up will continue until 3 months~     postpartum. Patients will be recruited by their treating physician, either an obstetrician or~     internist.~   "
132829|NCT01828684|"~     Approximately 9% of men and 18% of women suffer from migraine headaches. Almost all migraine~     sufferers report light sensitivity during a headache. Some people with migraine report that~     light can trigger their migraines and some people with migraine are light sensitive all of~     the time. The investigators have recently determined that certain colors of light are more~     likely to trigger migraines than other colors. In this study the investigators want to know~     if people who wear glasses that block these colors of light will have fewer migraine~     headaches.~   "
132830|NCT01828671|"~     Tortillas are a staple food in several cultures and are widely used to make tacos, burritos,~     and enchiladas. These foods are gaining a significant segment of the North American fast food~     and restaurant industry. From a health point of view, the addition of soy flour into corn~     tortillas will improve the nutritional profile of the tortillas and the presence of soy~     protein, dietary fibre and bioactive components has the potential to yield other health~     benefits. It is hypothesized that the addition of soy flour to corn tortillas will lower the~     glycemic index which could benefit those individuals with type 2 diabetes.~      The purpose of this research is to investigate whether different levels of soy flour in corn~     tortillas influences the glycemic response.~   "
132831|NCT01828658|"~     The investigators developed a prospective, randomized, controlled trial to compare strict~     volume control using bioimpedance (using the BCM - Body Composition Monitor device) versus~     traditional clinical volume control in hemodialysis patients and the impact on mortality,~     hydration status, blood pressure values and arterial stiffness.~   "
132832|NCT01828645|"~     Carbohydrate enriched-drinks has been used as preoperative treatment up to two hours before~     anesthesia. These drinks are safe and are not associated to bronchial aspiration during~     anesthesia. The addition of protein may be beneficial for metabolic preconditioning but there~     is a few data in literature testing these drinks for safety. The aim of the study will be to~     investigate the residual gastric volume (RGV) measured during the gastroscopy with~     abbreviation of fast to 2h with a carbohydrate plus whey protein enriched-drink.~   "
132846|NCT01828463|"~     SONIA 1 is an international, multicentre, randomised, open-label, no-treatment controlled,~     parallel group, dose-response study to investigate the effect of once daily nitisinone on~     24-hour urinary homogentisic acid excretion in patients with alkaptonuria after 4-weeks~     treatment. They study will identify the optimal dose to decrease urine homogentisic acid to~     near normal levels.~   "
132890|NCT01827878|"~     This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single~     dose, cross over pivotal study. The purpose of this study is to assess the bioequivalence~     between Test Product and the corresponding Reference Product under fed condition in normal,~     healthy, adult, human subjects.~   "
132891|NCT01827865|"~     This is a open Label, balanced, randomized, single dose, two-treatment, two-sequence,~     two-period, crossover, oral pivotal bioequivalence study. The purpose of this study is to~     assess the bioequivalence between Test Product and the corresponding Reference Product under~     fasting condition in healthy, adult human subjects.~   "
132833|NCT01828632|"~     Background. Morbidly obese patients show an increased risk of hypoxemia and a higher~     incidence of postoperative pulmonary complications during the postoperative period resulting~     in prolonged hospital length of stay when compared with normal weight subjects. Preoperative~     respiratory physiotherapy including inspiratory muscle training (IMT) has been shown to~     reduce the incidence of post operative respiratory complications in some different settings.~      Objective. To determine wether a program of preoperative respiratory physical therapy could~     reduce the incidence and severity of postoperative hypoxemia in morbidly obese patients~     undergoing laparoscopic bariatric surgery.~      Setting. Hospital Clínico Universitario, Valencia, Spain.~      Design and Patients. A double-blind, randomized clinical trial. 50 patients (BMI≥40%)~     consecutively scheduled for laparoscopic bariatric surgery were included of whom 44 completed~     the study. Sample size was calculated using the repeated measures of the PaO2/FiO2 ratio~     along the postoperative period as the primary endpoint and considering an effect size of~     0.25.~      Interventions. Patients were randomly assigned to receive either preoperative respiratory~     physical therapy (n=23) or usual care (n=21) during a month just before the date of surgery.~     Both groups received the same postoperative physical therapy.~      Measures. Data on oxygenation (primary outcome, PaO2/Fio2 ratio) were obtained at 1hour and~     at 12 hours after surgery. Data on spirometry and maximum static respiratory pressures~     (secondary outcomes) were obtained before and after the training period, and in the~     postoperative period.~   "
132834|NCT01828619|"~     The purpose of this study is to determine whether the new RIC regimen, containing of low dose~     of Bu (9.6mg/kg)and fludarabine without ATG, is suitable and effective in treating aged~     and/or intolerable patients with hematologic malignant disease, who undergoes allogenic stem~     cell transplantation.~   "
132835|NCT01828606|"~     Although there is no doubt about the need for compression therapy in lymphoedema, it is not~     investigated in much detail how much pressure is needed to get optimum volume reduction. New~     research suggests that there is obviously an upper pressure limit beyond further increase of~     pressure seems contra productive. This upper limit is around 30-40 mm Hg of initial pressure~     exerted by inelastic bandages on the upper and around 50-60 mm Hg on the lower extremity.~     This study is designed to investigate the effect of pressure on %volume reduction of leg~     lymphoedema with 2 bandages which are very comparable in product properties (slippage,~     stiffness, etc.), but differ in their pressure exerted to the limb.~   "
132836|NCT01828593|"~     The purpose of the study is to evaluate the effectiveness of the oral nutritional therapy~     serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g twice a day (BID) and SBI 5.0~     g versus placebo on supporting nutrient absorption in HIV+ subjects with HIV-associated~     enteropathy.~   "
132837|NCT01828580|"~     The main objectives of this study are to evaluate the safety and performance of the AutoLap~     system in Laparoscopic Cholecystectomy procedures.~   "
132838|NCT01828567|"~     The VA has committed to disseminate a web-based Healthy Living Assessment tool and use it as~     the cornerstone of a personalized prevention plan to engage patients to improve their health~     behaviors that lead to high health risk. Health risk assessments done in isolation, however,~     do not generally lead to behavior change. Our study will test the effectiveness of a Shared~     Decision Making intervention designed to activate Veterans to enroll in effective prevention~     programs. The intervention will be conducted over the telephone, by a prevention coach, and~     will be linked to the patients' primary care team. The co-primary outcomes will be patient~     activation and patient enrollment in prevention programs; 10-year risk of major cardiac~     events will also be measured.~   "
132839|NCT01828554|"~     The purpose of this research study is to find what happens to capecitabine in the body when~     dosed using actual versus ideal body weight in subjects with advanced tumors and elevated~     body mass index.~   "
132840|NCT01828541|"~     The purpose of this study is to determine whether hypnosis will decrease the intensity of~     either pain or itch in patients who have sustained a burn injury. Primary hypothesis:~     Hypnosis will provide more effective relief from post-burn itch and pain than a control~     intervention at 1-month, 3-months, 6-months and 1-year post-burn injury.~      Secondary hypothesis 1: Subjects treated with hypnosis will report better sleep quality and~     fewer symptoms of Post Traumatic Stress Disorder (PTSD).~      Secondary Hypothesis 2: Subjects treated with hypnosis will require less escalation of the~     gabapentin doses and have lower average pain scores than those in the control group.~      Exploratory Hypothesis: Subjects who will randomize to the hypnosis treatment group early~     after injury will report lower rates of neuropathic pain and itch than subjects who will be~     enrolled in the study and receive hypnosis later in the healing process.~   "
132841|NCT01828528|"~     The purpose of this study is to investigate the effect of weight loss rate on liver~     steatosis, steatohepatitis, fibrosis and cardiovascular risk at different stages before and~     after bariatric surgery. The investigators also aim to study the short-term effect of~     bariatric surgery on gastric cholecystokinin levels before and 10 days after the bariatric~     surgery.~   "
132842|NCT01828515|"~     The purpose of this study is to examine whether vilazodone attenuates the memory and mood~     effects of corticosteroids on the human hippocampus in 18 healthy controls.~   "
132843|NCT01828502|"~     RATIONALE: Providing parent/caregivers of children with cancer with education and evidence of~     secondhand smoke exposure can protect the child from future exposure to tobacco smoke.~      PURPOSE: This randomized study will compare education only to education plus cotinine~     feedback in decreasing secondhand smoke exposure in pediatric patients with cancer that~     reside with a household smoker.~   "
132844|NCT01828489|"~     This study evaluates the effect of different induction courses in children and adolescents~     with newly diagnosed acute myeloid leukemia. In the first course patients are randomised to~     receive either standard anthracycline therapy with mitoxantrone or experimental DaunoXome. In~     the second course patients are randomised between standard treatment with ADxE (cytarabine,~     DaunoXome, etoposide) or experimental therapy with FLADx (fludarabine, cytarabine,~     DaunoXome).~   "
132845|NCT01828476|"~     The purpose of this study is to assess the effect of combining abiraterone with medicines~     that may block some of the ways that cells become resistant to abiraterone. The investigators~     hope that these combinations of medicines will result in prostrate cancer cells dying.~      This study will see if overcoming diseases resistance to abiraterone will restore sensitivity~     to androgen deprivation therapy.~   "
132847|NCT01828437|"~     Infantile spasms constitute a unique age specific epilepsy syndrome of infancy, characterized~     by epileptic spasms often accompanied by neurodevelopmental regression and an EEG finding of~     hypsarrhythmia. When all 3 components are present, the eponym West syndrome is commonly~     used. West syndrome is a catastrophic epileptic encephalopathy. It does not respond well to~     standard anti-epileptic drugs. Hormonal therapy is the mainstay in the treatment of infantile~     spasms. This includes adreno-cortico trophic hormone (ACTH) and oral steroids. Variable dose~     of prednisolone used in the treatment. Oral prednisolone used in usual dose (2mg/kg) has been~     shown to be less effective as compared to ACTH. High dose prednisolone (4mg/kg) has been used~     in the treatment of infantile spasms, which has been shown to be as effective as ACTH.~     Pyridoxine has been used as first line treatment in Japan, however there is paucity of data~     on the efficacy of combination of pyridoxine with hormonal therapy. There are no studies~     comparing add on pyridoxine with high prednisolone versus high dose prednisolone alone in the~     treatment of infantile spasms. Therefore the study has been planned to see whether the~     addition of pyridoxine with high dose prednisolone in the treatment of infantile spasms~     improves the efficacy in terms of spasm cessation.~   "
132848|NCT01828424|"~     There is a large variability of postoperative pain intensity and of the drug doses necessary~     to alleviate this pain. The investigators hypothesis is that a measurement of nociception at~     the end of surgery, using either the RIII reflex threshold, measures of heart rate~     variability or the pupil dilatation reflex measured by pupillometry, in relation to the doses~     of opioids used intraoperatively will yield a prediction of postoperative pain.~   "
132849|NCT01828411|"~     This prospective observational pilot study investigates transpharyngeal ultrasonography (TPU)~     as an additional neuromonitoring strategy to assess cerebral perfusion during on-pump~     cardiovascular surgery.~      In the first part of the study the investigators will investigate the feasibility of TPU for~     visualization of aortic arch branches including the innominate and the carotid arteries in~     twenty patients undergoing coronary artery bypass grafting with extracorporeal circulation~     (cohort 1.). In the second part the investigators plan to adopt the investigators previous~     experiences on TPU to a selected population of twelve patients undergoing ascending aortic~     and/or arch repair in deep hypothermic circulatory arrest (DHCA, cohort 2.). In contrast to~     cohort 1., patients in cohort 2. are exposed intraoperatively to intermittent cerebral~     perfusion stops or reductions due to surgical procedure, perfusion technique and their~     underlying disease (aortic dissection or aortic aneurysm).~      The investigators hypothesize that cerebral perfusion monitoring using TPU as a non-invasive~     technique provides a simple and real-time adjunct to assess blood flow velocity in the~     extracranial cephalic vessels with Doppler ultrasound. Especially in aortic arch surgery with~     its inherent risk of cerebral hypoperfusion TPU might be a valuable adjunct to routine.~   "
132850|NCT01828398|"~     After stroke a limited motor recovery in the paretic upper limb accounts for a large~     proportion of the disabling sequelae. Only about 15% of those with initial complete upper~     limb paralysis after stroke recover functional use of their impaired arm in daily life.~      The aim of this study is to test the effects of tDCS combined with upper extremity~     robot-assisted therapy on stroke survivors.~   "
132851|NCT01828385|"~     The aim of this study is to determine the recovery time of moderate neuromuscular blockade~     with sugammadex in adults pretreated with magnesium sulfate.~   "
132852|NCT01828372|"~     The study includes two study parts in which blood is collected from the patients.~      Study part A (observational study, already received positive ethics committee vote; Our sign:~     12-330): Use of blood samples gathered during routine blood withdrawal Study part B~     (interventional study in the sense of additional blood samples but without an investigational~     product): Optional, for further pharmacokinetic questions: blood withdrawal with a maximum of~     20 ml ( ten tubes of 2 ml each) within a maximal study length of four weeks.~      The primary objective of this study is to gain an overview about drug concentrations in~     plasma and/or cerebrospinal fluid (CSF), in order to determine pharmacokinetics of drugs in~     patients. Any drug may be tested, however the initial focus is on antiinfective,~     antineoplastic, and antipsychotic drugs.~      Many published studies show that there is a profound lack of information on pharmacokinetics~     and interactions of many commonly used drugs in clinical routine, and that drug~     concentrations, if controlled by therapeutic drug monitoring, are not in the therapeutic~     range (provided that such ranges are known at all).~   "
132853|NCT01828359|"~     The purpose of this study is to evaluate the blood pressure lowering effects of an~     amlodipine/losartan combination treatment and losartan/Hydrochlorothiazide combination~     treatment in patients with essential hypertension uncontrolled with losartan 100mg~     monotherapy.~   "
132854|NCT01828346|"~     This is a dose escalation followed by dose expansion study of TL32711 in combination with~     5-Azacitidine in subjects with Myelodysplastic syndrome who are naïve, have relapsed or have~     failed prior 5-azacitidine therapy. Pre-clinical and mechanistic studies support that~     5-Azacitidine may modulate pathways that enable birinapant-mediated anti-tumor activity.~   "
132855|NCT01828333|"~     The MATIAS study aims to demonstrate through limited scope implementation studies how~     injectable artesunate may be progressively rolled out nationwide in the Democratic Republic~     of the Congo as the preferred treatment for severe malaria.~   "
132856|NCT01828320|"~     There is an urgent need to identify modifiable mechanisms contributing to risk and~     vulnerability among youth. The investigators test the hypothesis that eveningness, the~     tendency to go to sleep late and wake late, is an important contributor to, and even cause~     of, vicious cycles that escalate vulnerability and risk among youth. This study seeks to~     determine whether two interventions to reduce eveningness can reduce risk and confer~     resilience in critical aspects of health, development and functioning in youth.~   "
132857|NCT01828307|"~     Relapse contributes significantly to the chronicity of substance use disorders, one of the~     most costly medical/mental health problems facing our nation. The incorporation of exercise~     into relapse prevention efforts will address stress, a critical factor in relapse, provide~     other health benefits, and improve overall quality of life. Combined, these changes will~     reduce the risk of relapse to substance use while also lessening the burden of this~     psychiatric disorder upon society~   "
134110|NCT01811901|"~     In patients with acute ischemic stroke: the sooner the thrombolysis treatment is administered~     after symptom onset - the better the outcome. This delay can be dissected into onset-to-door~     time and door-to-needle time (DNT). SITS-WATCH aims to reduce median DNT in participating~     centres.~   "
132858|NCT01828294|"~     The study is being done with patients with Myasthenia Gravis (MG), age 18-80 years, positive~     acetylcholine receptor antibody, receiving greater than 30mg of prednisone daily. Patients~     may or may not be receiving anticholinesterase agents. A common treatment for patients with~     this disease includes the administration of intravenous immunoglobulin (IVIG), which is a~     plasma protein that is given to help maintain adequate antibody levels to prevent infections~     and decrease the symptoms of the disease of Myasthenia Gravis. This study is being done to~     test if giving this medication in a subcutaneous form (into the fat of the abdomen, legs and~     thighs) will be better tolerated for patients with Myasthenia Gravis.~   "
132859|NCT01828281|"~     We hypothesize that patients with untreated OSAS will have more visceral fat, fatty liver and~     increased carotid artery thickness whereas treatment with CPAP may reduce the mesenteric and~     liver fat, plasma lipids, carotid artery thickness.~   "
132860|NCT01828268|"~     The purpose of this plot study is to find out the relationship between metabolic changes and~     anti-retroviral therapy (ART), life style and clinical conditions of HIV-infected patients~     using nuclear magnetic resonance (NMR) based systems biology approach and metabolomics~     methodology.~   "
132861|NCT01828255|"~     The purpose of this study is to investigate how the intraocular pressure (IOP) varies in time~     and if the IOP variations are associated with the worsening of glaucoma. IOP patterns will be~     recorded continuously over 24 hours with SENSIMED Triggerfish®, a portable investigational~     device using a contact lens sensor. After completing the Triggerfish lens placement and~     removal; the patient will complete a formal Polysomnography.~   "
132862|NCT01828242|"~     Life style changes, particularly in dietary patterns have contributed a great deal to the~     incidence and risks of type 2 Diabetes. Decreased intakes of vegetables and fruits replaced~     by pre processed food, added sugar and those of animal origin lead towards rapid increase of~     adult-onset-diabetes.~      In spite of the knowledge of the benefit of consuming vegetable and fruits, and people are~     well informed, they still need to be committed to perform a behavior and implement these~     intention. Behavioral approach methods have demonstrated successful adherence in health~     education with life style changes.~      Objective: To identify the impact of The Empowerment Model to enhance vegetable intake in~     Type 2 Diabetes Mellitus adults in achieving glycemic control.~   "
132863|NCT01828229|"~     Epidemiological studies as well as both longitudinal animal and human inactivity studies~     indicate that low physical activity is associated with the pathophysiology of type 2 diabetes~     mellitus (T2DM) and obesity, and recently it has been estimated that physical inactivity~     (worldwide) causes 7% of the burden of disease related to e.g. T2DM. Physical inactivity, a~     high energy dietary intake, and T2DM are also associated with dementia, depression, and~     impaired cognitive function. It is critical that we understand how inactivity alters body~     composition, glucose and lipid metabolism, and cognitive function, if normal physical~     activity can prevent these changes, and if there are any differences between sexes.~      The present protocol is divided in several in several sub-studies:~        1. To test whether and how a physically inactive lifestyle will influence body composition,~          glucose and lipid metabolism, and cognitive function.~        2. To test whether normal physical activity can prevent the deleterious effect of a~          physically inactive lifestyle despite a high-caloric intake.~        3. To test whether the influence of a physically inactive lifestyle combined with a~          high-caloric intake differs between sexes.~   "
132864|NCT01828216|"~     Very few studies have examined different models of care involving initial ambulatory~     home-based diagnosis in diagnosing obstructive sleep apnea (OSA), identifying patients who~     benefit from continuous positive airway pressure (CPAP), and reducing the need for~     polysomnography (PSG). This study aims to assess the role of an ambulatory approach with home~     diagnostic sleep study. We hypothesize that the ambulatory approach is as good as the~     conventional approach in managing OSA in terms of improvement of clinical outcome but the~     former approach will lead to substantial cost savings.~   "
132865|NCT01828203|"~     The objective of this study is to assess the efficacy of IV minocycline in improving~     neurological and functional outcome after acute non-penetrating traumatic spinal cord injury~     (SCI).~      The primary hypothesis is that intravenous minocycline twice daily (800 mg initial dose~     tapered to 400 mg by 100 mg at each dose then administered to the end of day 7) administered~     to subjects with acute traumatic non-penetrating cervical SCI starting within 12 hours of~     injury will improve motor recovery as assessed by the International Standards for Neurologic~     Classification of Spinal Cord Injury - ISNCSCI (a.k.a. ASIA) neurological examination~     measured between 3 months and 1 year post-injury, compared to placebo.~      The secondary hypotheses are that the above minocycline treatment will also results in~     improvement in ASIA sensory improvement, in ASIA grade and in functional outcome as assessed~     by Spinal Cord Independence Measure (SCIM) and Short Form 36 (SF-36), compared to placebo. In~     addition the effect of minocycline on neurological and functional outcome after SCI is~     expected to be more pronounced in those subjects with motor incomplete SCI compared to those~     with motor compete SCI. A subgroup analysis will be undertaken to examine this hypothesis.~   "
132866|NCT01828190|"~     The aim of this study is to evaluate the effect of hyperbaric oxygen therapy (HBOT) on~     patient suffering from residual Crohn's disease related perianal fistulas already treated~     with TNF alpha blockers~   "
132867|NCT01828177|"~     This 4-arm Phase 2 vehicle-controlled study is designed to assess the safety and efficacy of~     PDI-320, and the individual components, in adult subjects with rosacea.~   "
132868|NCT01828164|"~     To study whether or not the Aevo System™ medical device enhances the rate of tooth movement~     in human subjects who use orthodontic braces.~   "
132869|NCT01828151|"~     To assess risk of skin pressure lesions in patients treated with noninvasive mechanical~     ventilation.~   "
132884|NCT01827956|"~     Hypothesis:~      Cetuximab, an anti-EGFR antibody, is used with radiotherapy in the treatment of locally~     advanced and inoperable upper aerodigestive tract cancers. Actually, no predictive biomarkers~     of Cetuximab antitumor activity are known in this setting. It has been shown recently that~     FCγRIIIA and FCγRIIA receptor polymorphisms played a role in antitumor activity of~     trastuzumab and cetuximab.~      The investigators therefore hypothesized that FCγRIIIA and FCγRIIA receptor polymorphisms may~     play a predictive role in Cetuximab effectiveness in upper aerodigestive tract cancers with~     recurrence or metastatic disease that make them inaccessible to loco regional treatment.~   "
132870|NCT01828138|"~     Preeclampsia (PE) is a common disorder of pregnancy that complicates 4-7% of all pregnancies.~     It is a serious condition with acute proteinuria and hypertension and varying degrees of~     edema after 20 weeks of gestation. PE leads to a severe risk of low birth weight because of~     prematurity with inherent complications. The pathogenesis is unknown but is assumed to~     involve placental ischemia.The primary placental disorder results in renal glomerular injury.~     Established PE is associated with paradoxical suppression of the~     renin-angiotensin-aldosterone system, RAAS.~      Despite suppressed RAAS, patients with PE retain NaCl(sodium chloride) after an intravenous~     isotonic NaCl overload compared to healthy pregnant women on a low NaCl diet. The~     investigators believe to have data that provide a possible explanation for the overall~     relationship between proteinuria, NaCl retension, suppression of RAAS, hypertension and~     underdevelopment of placenta. Earlier data, which the investigators have confirmed, shows~     abnormal glomerular loss of the enzyme plasmin/plasminogen from plasma to the urine in PE.~     Active plasmin in urine from patients with nephrotic syndrome and PE activates the epithelial~     sodium channel ( ENaC ) in renal collecting duct cells. The investigators hypothesize that~     loss of plasmin/plasminogen are shared for the diseases with proteinuria, including PE, and~     that plasmin- driven ENaC (epithelial sodium channel) activation is a causal factor in the~     pathophysiology of established PE. Hyperactive ENaC causes primary renal sodium retention~     with secondary suppression of the renin-angiotensin-aldosterone system. Aldosterone is~     recently established as a placental growth factor.~      Plasma-aldosterone levels are significant higher in normal pregnant women. PE is~     characterized by low aldosterone levels (a discovery the investigators have also confirmed)~     and by placental underdevelopment.~      Study Aim: To test specific hypothesis regarding established PE´s pathophysiological~     mechanisms.~      Study Hypothesis:~        1. Excretion of urine proteases (plasmin/plasminogen) in PE leads to an activation of ENaC~          and hence RAAS is less NaCl sensitive while the blood pressure is more NaCl sensitive~          compared to healthy pregnant women.~        2. The degree of aldosterone suppression in PE determines placental development~   "
132871|NCT01828125|"~     In the unfortunate case of severe hypoglycaemia, glucagon is the first-line treatment because~     of its potent and rapid action starting as fast as 5 minutes after subcutaneous or~     intramuscular injection. Large dose of glucagon such as 1 mg subcutaneous is usually~     associated with undesirable side-effects such as nausea, vomiting, bloating and headache.~      The overall objective of this research proposal is to assess the efficacy of lower~     subcutaneous doses of glucagon (0.1 mg or 0.2 mg) to correct hypoglycaemia compared to the~     standard dose (1.0 mg) in adults with type 1 diabetes mellitus (T1D).~      It is postulated that much lower dosages of glucagon (0.1 or 0.2 mg) injected subcutaneously~     will be just as effective as the current recommended dose of 1.0 mg to correct hypoglycaemia~     without the undesirable gastro-intestinal side effects.~   "
132872|NCT01828112|"~     The primary purpose of the study was to compare the antitumor activity of LDK378 vs.~     chemotherapy in patients previously treated with chemotherapy (platinum doublet) and~     crizotinib.~   "
132873|NCT01828099|"~     The primary purpose of the study was to compare the antitumor activity of LDK378 versus~     reference chemotherapy. Patients in the chemotherapy arm were allowed to cross-over to LDK378~     after confirmed progressive disease (PD).~   "
132874|NCT01828086|"~     A randomized, double-blind, placebo and positive controlled, single and multiple dose study~     to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of CJM112 in~     chronic plaque-type psoriasis patients.~   "
132875|NCT01828073|"~     This study will evaluate the safety and pharmacokinetics (PKs) of exposure (in utero or~     intrapartum) to raltegravir (RAL) in infants born to HIV-infected pregnant women who received~     RAL during pregnancy. (Pharmacokinetics are the various interactions between a drug and the~     body.) This study will also seek to develop an infant RAL dosing regimen to be evaluated in a~     follow-up study.~   "
132876|NCT01828060|"~     The purpose of this study is to evaluate the timing and magnitude of improvements to red~     blood cell health associated with consumption of Jobelyn™.~   "
132877|NCT01828047|"~     The aim of this pilot study is to establish if a correlation between sub-lingual~     microcirculation measured by Orthogonal polarization spectral (OPS) imaging and symptoms of~     postoperative ileus exist in patients undergoing elective colorectal surgery.~   "
132878|NCT01828034|"~     The purpose of this study is to test an investigational combination of drugs for bile duct or~     gallbladder cancers. Gemcitabine and cisplatin are two forms of chemotherapy commonly used in~     combination to treat bile duct and gallbladder cancers. The investigators are looking to~     improve treatment results. They will attempt to do so by adding the drug MEK162 to the~     treatment plan. MEK162 acts by blocking a protein called MEK 1/2 which helps cancer cells~     grow and divide. This study will help answer the question of whether MEK162 is a helpful drug~     in patients with bile duct or gallbladder cancers when given with gemcitabine and cisplatin.~   "
132879|NCT01828021|"~     The purpose of this study is to determine if margetuximab is effective in the treatment of~     certain patients with relapsed or refractory advanced breast cancer.~   "
132880|NCT01828008|"~     To study the safety and efficacy of CD20 antibody usage followed by CIK transfusion in~     refractory and/or chemoresistant lymphomas.~   "
132881|NCT01827995|"~     It is estimated that around 50 000 women die every year due to consequences of unsafe~     abortion (Singh et al, 2009). A majority of these deaths occur in low-income countries where~     access to safe abortion care is limited. Unplanned pregnancy and unsafe abortion thus place a~     huge burden on scarce medical resources. Any improvement in Comprehensive Abortion Care (CAC)~     would mean important improvements for the concerned women and their families (Singh, 2006) as~     well as for the societies at large. Recommended improvements concern increased access to the~     safest and most cost-effective methods such as medical abortion provided at primary level~     facilities (Singh et al, 2009). A Cochrane Review concludes that most randomised controlled~     trials within the field of medical abortion are conducted in high-income settings with good~     access to emergency health care services (Kulier et al, 2004). A simplified regime for~     medical abortion, which could be used at primary level facilities, would contribute to the~     reduction of maternal mortality and morbidity related to unsafe abortions globally. However,~     there is a knowledge gap in order to determine if a simplified follow up of medical abortion~     is equally effective as the standard procedure in a low-income setting. The results will~     provide evidence-based information to be used in revising training and service delivery~     guidelines' in order to reduce maternal mortality and morbidity in both low and high-income~     setting.~   "
132882|NCT01827982|"~     The purpose of this study to evaluate the safety, tolerability, pharmacokinetics and~     pharmacodynamics of JNJ-54861911 which is currently being developed for the treatment of~     Alzheimer's Disease.~   "
132883|NCT01827969|"~     The treatment consists of tumor ablation by Ablathermy Focused Ultrasound (USF), guided by~     MRI, performed under local anesthesia and sedation.~   "
132885|NCT01827943|"~     In the absence of standard treatment in this indication, this test evaluates a new drug type~     targeted therapy in this indication, evaluating its efficacy in terms of tumor response and~     survival.~   "
132892|NCT01827852|"~     This prospective observational study will evaluate the efficacy and safety of first-line~     Avastin (bevacizumab) in combination with platinum-based chemotherapy in different age groups~     (<60, 60-69, 70-79, >80 years) in patients with inoperable advanced, metastatic or recurrent~     adenocarcinoma non-small cell lung cancer. Patients will be followed for 18 months from the~     start of first-line therapy.~   "
132893|NCT01827839|"~     The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals'~     HZ/su vaccine in subjects' ≥ 50 years of age (YOA) who previously have had Herpes Zoster~     (HZ). The data collected will be compared with the data from subjects without HZ in other~     HZ/su trials.~   "
132894|NCT01827826|"~     It is estimated that 30 million U.S. adults will have type 2 diabetes by 2050. Contributing~     to this national trend is the obesity epidemic. Three randomized trials have demonstrated~     that intensive behavioral interventions can prevent or delay the onset of diabetes. The~     purpose of this pilot study is to inform a future randomized, controlled Phase III trial of a~     population-based, telephonic, exercise and weight loss intervention to translate the findings~     of the Diabetes Prevention Program into practice. The telephonic intervention will be~     compared to usual care (30 participants in each group). The investigators will deliver the~     intervention in 12 weekly, 20-minute calls, with four subsequent maintenance calls, for a~     total of 16 calls over 24 weeks. Study outcomes will be measured at baseline and at 12 and 24~     weeks.~      For this planning grant the investigators do not have an overall hypothesis. The~     investigators' goal is to develop and test whether it is possible to do exercise and weight~     loss~   "
132895|NCT01827813|"~     OBJECTIVE To assessment the results of repeated saturation and 10-12 core biopsy protocols in~     patients with a negative initial biopsy but continued suspicion for prostate cancer MATERIALS~     AND METHOD Data of the patients who underwent prostate biopsy between June 2007 and June 2012~     were retrospectively assessed. Patients with an abnormal digital examination findings and/or~     abnormal serum prostate specific antigen levels were biopsied. The indication for a repeated~     biopsy was determined as the continued suspicion for a malignancy after the initial benign~     biopsy result and/or a pathology result consistent with a high-grade prostatic~     intraepithelial neoplasia or atypical small acinar proliferation. Patients who underwent~     saturation and core 10-12 biopsies at repeated biopsies were compared. Statistical analyses~     were performed with Shapiro-Wilk test and Mann- Whitney U test. A p value less than 0.05 was~     accepted as statistically significant.~   "
132896|NCT01827800|"~     This purpose of this trial is to determine whether a 12-month eHealth behavioral intervention~     that includes interactive self-monitoring and feedback, tailored skills training materials,~     telephone counseling calls, and primary care physician (PCP) counseling will produce greater~     weight change at 12 months than a standard primary care control.~   "
132897|NCT01827787|"~     This research study is a phase II clinical trial. Phase II clinical trials test the~     effectiveness of a drug to learn whether the drug works in treating a specific cancer.~      Eribulin is a chemotherapy approved by the US FDA in November of 2010 to treat patients with~     metastatic breast cancer who have received at least two prior chemotherapy regimens. It works~     by interfering with cancer cell division, growth and spread.~      In this research study, the investigators are looking to see how well Eribulin helps~     participants with metastatic breast cancer as a first-line or second-line chemotherapy~     treatment. The investigators also would like to learn about the side-effects that~     participants experience with this medication, in particular, neuropathy.~      Neuropathy is a condition in which the nerves are affected, leading to numbness or tingling~     of the fingers and toes. The investigators would like to study the effect Eribulin has on the~     nerves through regular questionnaires that ask about any nerve-related symptoms. The~     investigators also plan to send blood samples to determine if gene markers may indicate~     increased sensitivity to the nerve effects of Eribulin.~   "
132898|NCT01827774|"~     The purpose of this Study is to collect information about the performance of the Surgisis®~     Soft Tissue Graft (Study Product) for the repair of pelvic organ prolapse in women.~   "
132899|NCT01827761|"~     This study will evaluate whether chemotherapy teaching sessions improves patient's knowledge,~     preparedness and anxiety in relation to chemotherapy. This study will also evaluate the~     effect of age, race, native language, education level, type of cancer and chemotherapy~     regimen on the oncology teaching session.~   "
132900|NCT01827748|"~     The purpose of this study is to evaluate the accuracy and repeatability of an individually~     validated prototype autorefractor designed to be mounted on a surgical microscope.~   "
132901|NCT01827735|"~     Type 1 diabetes is the most common severe chronic autoimmune disease worldwide and is caused~     by the autoimmune (loss of self tolerance) mediated destruction of the insulin producing~     pancreatic beta cells thus leading to insulin deficiency and development of hyperglycaemia.~     Currently, medical management of type 1 diabetes focuses on intensive insulin replacement~     therapy to limit complications (retinopathy, nephropathy, neuropathy); nevertheless clinical~     outcomes remain sub optimal. There are intensive efforts to design novel immunotherapies that~     can arrest the autoimmune process and thereby preserve residual insulin production leading to~     fewer complications and better clinical outcomes.~      The vast majority of genes that contribute to susceptibility to type 1 diabetes have been~     found to encode proteins involved in immune regulation and function. In particular, several~     susceptibility proteins are involved in the interleukin 2 (IL-2) pathway that regulates T~     cell activation and tolerance to self antigens. Aldesleukin is a human recombinant IL-2~     product produced by recombinant DNA technology using genetically engineered E. coli stain~     containing an analog of the human interleukin-2 gene. There is substantial nonclinical,~     preclinical and clinical data that ultra low dose IL-2 (aldesleukin) therapy can arrest the~     autoimmune mediated destruction of pancreatic beta cells by induction of functional T~     regulatory cells. However, prior to embarking on large proof of concept trials in type 1~     diabetes it is essential that the optimum dose of IL-2 (aldesleukin) is determined. The~     objective of this study is to establish in patients with type 1 diabetes the optimal dose of~     IL-2 (aldesleukin) to administer in order to increase T regulatory cell response.~   "
133044|NCT01825837|"~     This was an extension study consisting of 2 parts. In Part I, all participants received~     open-label treatment with BIA 2-093 900 mg once daily for 2 weeks. Part II followed a~     double-blind, parallel-group design in which participants were randomly assigned to treatment~     with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily. Patients stable in remission continued~     double-blind therapy until approximately 6 months after the last patient entered Part II.~   "
132902|NCT01827722|"~     CRVO occurs when the vessels in the back of the eye become blocked. This creates a dangerous~     condition because the vessels are weak and prone to leakage. This results in the development~     of macular edema.~      Previous studies have shown that inflammatory mediators and growth factors, such as vascular~     endothelial growth factor (VEGF), are elevated in patients with macular edema associated with~     CRVO.~      Ozurdex® is approved by the Food and Drug Administration (FDA) and is available by~     prescription for macular edema following CRVO and branch retinal vein occlusion (BRVO). It is~     also indicated for the treatment of non-infectious uveitis affecting the posterior segment of~     the eye. The approved dosage is 0.7 mg.~      Ranibizumab (Lucentis®) is approved by the Food and Drug Administration (FDA) and is~     available by prescription for other eye disorders, such as wet age-related macular~     degeneration (AMD), macular edema following CRVO or BRVO, and diabetic macular edema (DME).~     The approved dosage for wet AMD and macular edema following CRVO/BROV is 0.5 mg given~     monthly. The approved dosage for DME is 0.3 mg given monthly.~      Dr. Gonzalez is conducting an investigational study on the safety and effectiveness of~     treating CRVO-associated Macular Edema with a combination of 0.7 mg of Ozurdex® and 0.5 mg~     Lucentis®, given as separate injections into the eye.~   "
132903|NCT01827709|"~     Chemo-radiotherapy (CRT) is currently the cornerstone in the management of locoregional~     advanced head and neck cancer (HNC). Optimization of the quality of RT is therefore an~     important issue, if the investigators want to improve the therapeutic index in HNC. This~     could be achieved by a more accurate definition of the tumor volume and by identification of~     radioresistant volumes within the tumor. Recent literature puts in this regard the~     incorporation of functional imaging (FI) in the RT treatment planning forward as a promising~     tool.~      FI modalities provide an outstanding contrast between tumor and surrounding tissues. This is~     in contrast to anatomical imaging. Using anatomical imaging in RT treatment planning,~     sufficient margins need to be placed around the tumor volume in order to compensate for~     geometric uncertainties. Consequently many surrounding functional structures receive high~     doses of irradiation, resulting in side effects. It is expected that, using FI in RT~     treatment planning will make these margins smaller or even unnecessary, which will result in~     less irradiation of the surrounding tissues. So far only one study has reported a comparison~     between tumor volume on anatomical (CT and MRI) and FI (PET-CT) modalities with pathological~     tumor volume. This study showed indeed that the tumor volumes delineated on PET-CT correlated~     more to tumor volumes defined by pathology and were significantly smaller.~      Furthermore, FI provides us with a deeper insight in the tumor's underlying biological~     activity and microstructure. These techniques can thus help to identify radioresistant~     subvolumes which might benefit from treatment intensification.~      A validation of these FI modalities with pathology is necessary to investigate their true~     power in tumor delineation and in the identification of radioresistant subvolumes.~   "
132904|NCT01827696|"~     Healthy participants will ingest American ginseng daily or a placebo for four weeks prior to~     engaging in a unaccustomed exercise bout designed to induce mild-moderate muscle soreness.~     Muscle soreness will be assessed via decrements in muscle strength and with a self-rating of~     perceived soreness before and several times after the exercise.~   "
132905|NCT01827683|"~     The aim of the study is to evaluate the effect of hyperbaric oxygen therapy (HBOT) on~     patients suffering from chronic pain syndrome (Fibromyalgia).~   "
132906|NCT01827670|"~     Clinical studies have demonstrated long term relief from dentine hypersensitivity with twice~     daily brushing of a toothpaste containing stannous fluoride in comparison to marketed~     (negative) controls. The aim of this study is to evaluate the effectiveness of a stannous~     fluoride dentifrice in the treatment of dentinal hypersensitivity compared to a marketed~     (negative) control, over a period of 56 days (8 weeks) with twice daily brushing.~   "
132907|NCT01827657|"~     This is a single-dose, open-label, two part, parallel group study. This study is being~     conducted to determine the pharmacokinetics, safety and tolerability of GSK2336805 in~     subjects with varying degrees of hepatic impairment. Part 1 of the study will enroll subjects~     with mild and moderate hepatic impairment and healthy control subjects matched to the~     subjects in the moderate hepatic impairment category. The decision to commence Part 2 will be~     based on a review of the preliminary safety and pharmacokinetic data from subjects with~     moderate hepatic impairment. Part 2 will enroll subjects with severe hepatic impairment.~     Additionally, based on emergent data from Part 1, matched controls to the severe hepatic~     group may be enrolled (optional). Due to the potential difficulty in identifying eligible~     subjects with severe hepatic impairment, the study may be stopped prior to full enrollment in~     Part 2, provided that a minimum of 4 evaluable subjects with severe hepatic impairment have~     been enrolled. The study will consist of a Screening visit, a single dose Treatment Period~     and a Follow-up visit. Subjects will be screened for eligibility criteria within 30 days of~     enrolment. Subjects will be admitted to the clinical unit on Day -1; each subject will~     receive a single dose of GSK2336805 on Day 1 and will remain in the clinical unit for 5 days~     (check-out on Day 4). The follow-up visit will be conducted within 7-10 days after Day 1~     dosing.~   "
132908|NCT01827644|"~     This will be a randomized, open-label, sequential, single dose, 4-period crossover study.~     This study is being conducted to measure the relative bioavailability of the original gelatin~     capsule (GC) formulation and two new formulations (hydroxypropyl-methylcellulose [HPMC]~     capsule and enteric coated tablet [ECT]) of afuresertib (AFU), in the fed and fasted state.~     The study will be composed of Screening, Treatment, and Follow-up Periods. Screening~     assessments to determine subject eligibility will be performed within 3 weeks prior to the~     first dose of study drug in the Treatment Period. Eligible subjects will be randomized to~     receive 4 of the 6 possible study treatments (A: AFU GC administered in a fasted state, B:~     AFU GC administered in a fed state, C: AFU HPMC capsule administered in a fasted state, D:~     AFU HPMC capsule administered in a fed state, E: AFU ECT administered in a fasted state, F:~     AFU ECT administered in a fed state) in 4 treatment periods (one per treatment period).~     Subjects will receive a single dose of one of the six study treatments (A, B, C, D, E, F) on~     Day 1 of each Dosing Period, according to one of the 6 treatment sequences (CEDA, EFAB, ABFC,~     BDCE, FCBD, DAEF). There will be a minimum of 10 Day washout period between the doses~     administered in each Treatment Period. A Follow-up visit will be conducted within 10-14 days~     after the last dose. A subject's total time involved in the study will be approximately 9~     weeks. At least 36 subjects will be enrolled in the study, to ensure that at least 6 subjects~     will be randomized to receive each treatment sequence.~   "
132909|NCT01827631|"~     This is an open-label, parallel group, single and repeat dose pharmacokinetic (PK) study in~     healthy male and female subjects. This study will confirm the PK and safety profile in~     Chinese subjects. GSK1605786 is currently in clinical development for the treatment of~     Crohn's disease. Subjects will receive one of two GSK1605786 doses (500 mg once daily or~     500mg twice daily) within 30 minutes after a meal. The study will consist of single and~     repeat dose sessions, with pre-dose and serial PK samples taken up to 72-h post-dose.~   "
132910|NCT01827618|"~     This study aims to evaluate the effects of rapamycin directly on bladder tumors and the~     effects of rapamycin on the immune system of patients with bladder cancer.~   "
132911|NCT01827605|"~     This is a Phase III, multicenter, open-label, randomized and controlled study to compare the~     efficacy of a consolidation therapy with RIT versus ASCT in patients with FL in CR or PR~     after second or third line chemotherapy supplemented with rituximab.~   "
132912|NCT01827592|"~     Efficacy and Safety Trial of elobixibat in Patients with Chronic Idiopathic Constipation~     treated for 26 Weeks.~   "
132913|NCT01827579|"~     The purpose of this study is to evaluate whether the administration of allodepleted donor T~     cells to patients with haematological malignancies after stem cell transplant can improve the~     recovery of the patients immune system.~   "
132914|NCT01827566|"~     The purpose of this study is to assess the prevalence of Gluten Sensitivity, by a~     double-blind placebo-controlled challenge with gluten, followed by two months period of~     Low-FODMAPs (Fermentable Oligosaccharides Disaccharides Monosaccharides And Polyols) diet, in~     patients spontaneously adherent to gluten free diet because of symptoms upon gluten exposure~     and in whom diagnosis of Celiac Disease and Wheat Allergy has been ruled out.~   "
132915|NCT01827553|"~     This randomized trial examines the effectiveness of chemoradiotherapy compared to~     chemotherapy alone after induction chemotherapy with 3 cycles of gemcitabine or 6 cycles of~     FOLFIRINOX in patients with locally advanced, non resectable and non-metastatic pancreatic~     cancer. Chemotherapeutic agent in chemoradiotherapy is gemcitabine administered in 5 cycles,~     the agent and its administration for sole chemotherapy is determined by induction~     chemotherapy. Operability of tumor is evaluated at week 11 after randomisation. Patients will~     be followed for the duration of therapy and for 5 years after the last study treatment.~     Overall survival at the end of follow up is defined as primary endpoint. Secondary endpoints~     are tumor-free survival, rate of local recurrence or local progression, rate of distant~     metastasis, acute and late toxicity of the chemoradiotherapy, quality of life, rate of~     remission, rate of curative resections (R0) after chemotherapy and chemoradiotherapy. It is~     planned to include a total number of 830 patients.~   "
132916|NCT01827540|"~     To evaluate the PK, safety and tolerability of Cenicriviroc (CVC) administered with and~     without Dolutegravir (DTG) and CVC with and without a single dose of Midazolam in healthy~     subjects.~   "
132917|NCT01827527|"~     The purpose of this study is to develop and refine techniques for using magnetic resonance~     and optical spectroscopy to investigate how your body uses energy.~   "
132918|NCT01827514|"~     Erythropoietin, EPO, is the main regulator and stimulator of bone marrow erythropoiesis, and~     is responsible for growth and differentiation of the erythroid cell lineage. Our team, in~     collaboration with partners (see below) has taken responsibility to study the presence,~     function and clinical significance of EPO-R in human cancer specimens.~      General Aim of the Proposed Project: To study EPO-R in human cancer specimens. Prepared~     slides from already taken preparations (specimens from Bone Marrow tests) will serve as the~     basis for that part of the work.Specimens will be taken from Breast cancer, Colon cancer,~     Lung cancer, Head & Neck cancer and from Lymph nodes biopsy (positive for lymphoma) The~     slides will be stained with anti-EPO-R antibodies (Abs).~   "
132919|NCT01827501|"~     This study is designed to compare the incidence of postoperative delirium in older patients~     after major non-cardiac surgery with different perioperative hemodynamic managements: a goal~     directed hemodynamic management group and a control group~   "
132920|NCT01827475|"~     The purpose of this study is to determine whether the combination of ibuprofen and~     acetaminophen, is more effective than either single agent alone in treating pain from acute~     musculoskeletal injuries in the emergency department.~   "
132921|NCT01827462|"~     In this study the investigators are trying to understand how immune function declines in the~     elderly using annual influenza vaccinations as a model system. The longitudinal study began~     in 2007 and continued through early 2017.~   "
132922|NCT01827449|"~     The study will compare the rewarming effectiveness of heat donation through the distal arms~     and legs during rewarming of mildly hypothermic subjects. Warming will be accomplished~     through either warm water immersion; and fluidotherapy. The investigators hypothesize that~     fluidotherapy will be as, or more, effective compared to warm water immersion~   "
132923|NCT01827436|"~     The purposes of this pilot research study are 1. To begin to test if two different types of~     physical therapy might have different results in children and adolescents who have had a~     prior stroke, and 2. To determine if either type of physical therapy causes changes in the~     brain signals that control leg muscles. All participants will receive physical therapy 3~     times per week for 8 weeks. Half of the participants will receive typical physical therapy,~     such as walking practice, muscle strengthening, and balance training. Half of the~     participants will receive asymmetrical gait training physical therapy, which uses new~     technology to train each leg differently during walking practice. After enrolling,~     participants will be randomly assigned to the type of therapy. Measurements will be taken~     before, during, and after the 8 weeks of physical therapy. These include walking tests to~     measure symmetry, walking speed and daily step activity, and brain tests to measure the~     strength of the signals from the brain to the leg muscles. One blood test is also taken to~     identify if certain genetic factors affect how each child responds to the physical therapy.~   "
132924|NCT01827423|"~     This prospective study aimed to evaluate the usefulness of squamous cell carcinoma antigen~     (SCCA) as a clinical marker of sinonasal inverted papilloma (IP). The potential benefit of~     SCCA in the diagnosis of unilateral nasal pathology and as a marker of hidden recurrence was~     evaluated as well.~      Blood samples from patients with sinonasal IP were examined to determine serum SCCA levels~     before surgery, the day after surgery, and every 6 months during follow-up. Preoperative and~     postoperative levels of SCCA were compared.~   "
132925|NCT01827410|"~     Is there agreement between data in the Danish Ventral Hernia Database and patient files~   "
132926|NCT01827397|"~     The purpose of the clinical trial is to evaluate the safety and immunogenicity in female~     volunteers of EN41-UGR7C vaccine candidate adjuvanted with Alum using IM administration. The~     objective of the immunisation is to induce mucosal and systemic binding and neutralizing~     antibodies against HIV in order to block the virus on the mucosal surface and neutralise the~     viral particles that may eventually succeed in crossing the mucosal barrier.~      This is a Phase 1 exploratory study. EN41-UGR7C will be administered for the first time in~     humans.~      Volunteers who are vaccinated with EN41-UGR7C may develop an immune response against HIV, but~     its ability to induce meaningful protection against HIV will not be known before Phase 3~     efficacy trials are completed, as correlates of protection against HIV are not yet clearly~     defined.~      Consequently, there is no direct benefit to volunteers. They will be reimbursed for their~     time and travel.~   "
132927|NCT01827384|"~     This randomized pilot phase II trial studies molecular profiling-based targeted therapy in~     treating patients with solid tumors that have spread to other places in the body and usually~     cannot be cured or controlled with treatment. WEE1 inhibitor AZD1775, everolimus, and~     trametinib are drugs that each target a specific variation in tumors by blocking different~     proteins needed for cell growth. Veliparib blocks an enzyme that helps repair~     deoxyribonucleic acid (DNA) damaged by chemotherapy, which may help chemotherapy drugs work~     better. It is not yet known whether testing patients for variations in their tumor and~     assigning treatment targeting the variation is more effective than standard non-targeted~     therapy in treating advanced solid tumors.~   "
132928|NCT01827371|"~     Imvamune (licensed name of MVA being developed as a smallpox vaccine) has been tested in over~     2,000 individuals and is on path for licensure. This study will be a Phase II to evaluate~     three different immunization schedules and two different modes of delivery. The study will~     look at condensed schedules. Study will randomize subjects to one of four arms.~   "
132929|NCT01827358|"~     The objective of this trial is 1) to evaluate the safety and clinical acceptability of a~     5-day course of mupirocin applied every 8 hours (± 2 hours) to the nares, umbilical and~     perianal areas of infants residing in the ICU. 2) to examine the efficacy of mupirocin in~     eradicating SA colonization of infants in the ICU, defined as the absence of SA in cultures~     of the nares, umbilical, and perianal areas on day 8 (± 2) (primary decolonization) 3) to~     examine the efficacy of mupirocin in achieving persistent eradication of SA colonization~     among infants residing in the ICU,defined as the absence of SA in cultures of the nares,~     umbilical, and perianal areas. Duration is 36 months. Enrolled infants will continue to~     receive medical care as they otherwise would if they were not enrolled in the trial. The~     study will be powered with a primary endpoint with 126 participants. Enrollment may continue~     to 500 participants to power secondary and exploratory endpoints and assist design subsequent~     studies.~   "
132930|NCT01827345|"~     The role of vitamin D deficiency on increased risk for falls and physical dysfunction is~     unclear. It is also unclear if taking vitamin D improves physical function and reduces fall~     risk in older adults. The purpose of this research study is to explore the effects of taking~     the recommended dose of vitamin D (800 IUs/day) for six months on fall risk and physical~     functional outcomes in older adults with low vitamin D levels. The investigators hypothesize~     that the participants will experience fewer falls and function better physically after taking~     vitamin D for six months.~   "
132931|NCT01827332|"~     The purpose of this study is to examine the impact of a medication called oxytocin on~     marijuana use and therapy response in people who frequently use marijuana.~   "
132932|NCT01827319|"~     The objectives of the registry are as follows:~        -  Track real world performance outcomes and physician experience using the Cardiogenesis~          Laser System;~        -  Further define the disease characteristics of the population being treated;~        -  Examine transmyocardial revascularization (TMR) usage characteristics and 30-day~          outcomes;~        -  Further assess the 30-day postoperative risk factors for adverse events. To limit the~          potential for bias, all patients eligible for TMR treatment who meet the Inclusion and~          Exclusion Criteria are to be offered the opportunity to enroll in the study at~          participating centers.~   "
132933|NCT01827306|"~     Biofreeze® is a topical analgesic, frequently used in the office or given to a patient for~     home use as a way to mitigate pain during the course of treatment. Rehabilitative exercises~     are considered an important component of care for shoulder pain patients, although pain can~     be a limiting factor in the advancement of rehabilitation. The purpose of this study is to~     evaluate the addition of Biofreeze® to an in-office group of shoulder pain patients to~     determine its impact on pain reduction. Methods: Patients 18-64 years old with mechanical~     shoulder pain who are candidates for standard shoulder therapy will be randomized into two~     groups (N=20). The Control group (N=10) will receive standard shoulder therapy alone while~     the Intervention group (N=10) will receive standard shoulder therapy plus Biofreeze® just~     prior to initiating the in-office exercise program. Values of pain (NPRS) and disability~     (ASES) will be recorded at baseline, 2 weeks, and 4 weeks. Hypotheses will be addressed by~     repeated measures ANOVAs within and between group, time, and interaction main effects.~     Clinical Relevance: Progression of therapeutic exercises can be limited by pain and the~     associated disability. The ability to decrease shoulder pain and disability with a topical~     analgesic will allow health care professionals to advance patients through a therapeutic~     exercise program without the restriction of pain. In turn, patients will correct the~     underlying condition of their shoulder pain at a faster rate.~   "
132934|NCT01827293|"~     This study was a prospective, randomized, double-blind, parallel group clinical trial~     designed to compare the efficacy of intravenous (IV) promethazine and lorazepam for the~     treatment of peripheral vertigo in Emergency Department setting.~   "
132956|NCT01827007|"~     The aim of the study is to evaluate whether fluid responsiveness of the critically ill~     patient can be assessed by analysing the PEEP-induced hemodynamic effects to systolic blood~     pressure, pulse pressure, aortic blood flow, aortic time-velocity integral and left~     ventricular end diastolic area measured with transesophageal echocardiography (PEEP-test).~     The chances are compared to increase of CI after volume expansion (gold standard). In~     clinical practise, it would be especially relevant if PEEP-induced changes in arterial~     pressure variations could be used in evaluation of volume status and fluid responsiveness.~     However, as ECHO-derived variables are used in greater extent to guide the treatment with~     inappropriate evidence, the simultaneous registration of ECHO-derived hemodynamic~     measurements is essential in the study design.~   "
132935|NCT01827280|"~     The prevalence of obesity and type 2 diabetes mellitus (T2DM) has increased progressively in~     the past decades, and consequently, a higher incidence of cardiovascular diseases is~     observed. As this process develops, the endothelial dysfunction is present at early stages of~     the atherosclerotic disease. Studies conducted at BioVasc/UERJ show the occurrence of~     endothelial and microvascular dysfunction in obese carriers, even in the absence of~     dysglycemia. New concepts indicate the endothelium as a possible therapeutic target, and~     drugs which act not only on diabetes mellitus pathophysiology but also acting as direct~     cardiovascular protectors bring new therapeutic possibilities. The dipeptidyl-peptidase-4~     inhibitors (DPP4), such as vildagliptin, are drugs used on the T2DM treatment. Its incretin~     mimetic and insulinotropic effects are already well established and several other studies~     show its effectiveness in reducing glycated hemoglobin, even in monotherapy.~      Currently, fat rich foods are being increasingly introduced in the western way of life and~     recent evidence suggests that the postprandial lipemia (LPP) is related to cardiovascular~     risk. A better glucose control using vildagliptin can reduce the oxidative stress, and~     consequently promote a better microvascular and endothelial reactivity. However, vildagliptin~     can have an additional cardiovascular protective action, not only because of its effect on~     glycemia and oxidative stress reduction, but maybe because of its direct effect on intestinal~     peptides with postprandial lipemia reduction. To test this hypothesis, we will proceed the~     following exams: venous occlusion pletysmography, nailfold videocapilaroscopy and~     laser-Doppler flowmetry aiming to evaluate vascular reactivity on muscle and at cutaneous~     site. Anoter group of patients with the same clinical charactherisitics will use metformin,~     in order to compare its effects with those obtained from the use of Vildaglitpin. Our purpose~     is to determine whether vildagliptin, evaluated in obese and diabetic women, has vascular~     protective effects, and whether the regulatory mechanisms of these actions correlate with~     oxidative stress, inflammatory markers and intestinal peptides in baseline state and after a~     lipid overload.~   "
132936|NCT01827267|"~     This is a Phase 2, therapeutic-exploratory, adaptive design, open-label, multicenter,~     multinational study evaluating neratinib monotherapy and neratinib plus temsirolimus~     combination therapy in patients with non-small cell lung cancer (NSCLC) who have documented~     somatic HER2 mutations.~   "
132937|NCT01827254|"~     Retrospective and prospective study in mRCC patients treated with sutent in first line and~     rechallenged by Sutent in 3rd and 4th line.~   "
132938|NCT01827241|"~     With this study, we plan to review the performance of colonoscopy in colon cancer screening~     and surveillance, especially with the recent improvements in endoscopic technology (high~     definition endoscopes), use of split dose preparation which provides excellent colon~     preparation for detection of lesions and increasing awareness and detection of flat lesions~     of the colon. The findings will help us define the role of colonoscopy screening of colon~     polyps and flat lesions and identity areas for improvement. The data will be used for~     continuing quality improvement and presenting our outcomes at academic meetings and~     publishing our results in peer reviewed journals.~   "
132939|NCT01827228|"~     Half or more of HIV transmission events may occur within the period of high infectivity (and~     often high risk behavior) that can last 11 months or more after a person is initially~     infected. Unfortunately, neither test-and-treat intervention methods nor Acute HIV Infection~     projects have found effective ways to intervene against transmission during this risky~     recent infection period. The investigators seek to develop effective intervention~     techniques against HIV transmission during the recent infection period using a combination of~     injection-, sexual- and social-network-based contact tracing methods; community alerts in the~     networks and venues of recent infectees; and the logic of going up and down infection~     chains.~      The investigators first Aim is to develop and evaluate ways to locate seeds, defined as~     drug users and other people who have recently been infected. The investigators second Aim~     targets members of seeds' networks and people who attend their venues. The investigators will~     test them for acute and for recent infection, and alert them to the probability that their~     networks contain highly-infectious members so they should reduce their risk and transmission~     behaviors for the next several months to minimize their chances of getting infected. This may~     also reduce transmission by untested people with recent infection. Community, network and~     venue education about the need and value of supporting those with recent infection should~     reduce stigma. The investigators third Aim is to reduce HIV transmission and to develop new~     ways to evaluate prevention for positives generally as well as The investigators own~     success in reducing transmission.~      The investigators will do this using a combination of follow-up interviews and testing,~     including of viral loads; phylogenetic techniques; and discrete event simulation modeling to~     assess The investigators effectiveness.~   "
132940|NCT01827215|"~     This study is to examine the effectiveness of a health communication system (Gabby) that~     assesses preconception health risks and tailors the education and intervention to each~     subject, based on her health risks. This project specifically targets young Black or African~     American women in order to reduce major disparities in birth outcomes. Clinicians do not have~     time to assess for the over 100 preconception health risks that can impact birth outcomes;~     the investigators system can streamline that assessment and create a personalized list of~     risks. Patients can then share their list with clinicians to make their healthcare visits~     more effective.~      The investigators will conduct a two-armed randomized controlled trial (RCT) designed to~     enroll 530 African American women ages 18-25. After all subjects complete a comprehensive~     preconception health risk assessment, the intervention group will be trained to use the Gabby~     system and encouraged to use it at least monthly for one year. The control group will receive~     a letter listing the risks identified and they will be encouraged to see their clinician to~     discuss them.~      The investigators primary hypothesis will test whether the Gabby system will result in a~     lower rate of preconception health risks, as defined by CDC, as compared to the control group~     after 12 months. Secondary outcomes include: measurement of usage rates, dose of exposure,~     attrition, subject and healthcare provider satisfaction, and number of women with a~     personalized health plan.~   "
132941|NCT01827202|"~     Forced blockade of the renin-angiotensin-system (RAS) by using direct renin inhibition (DRI)~     has long been propagated to effectuate beneficial outcomes. However, recent large clinical~     trials have outlined harmful effects for DRI in combination with other forms of RAS blockade.~     To date, information regarding DRI as RAS-blocking monotherapy is very limited. Furthermore,~     it remains to be elucidated how DRI and angiotensin receptor blockers affect the so-called~     'classical' and 'alternative' RAS molecularly. As components of the 'alternative' RAS (e.g.~     Ang 1-7) have moved into research focus, it would be of importance to determine angiotensin~     regulation with medical RAS blockade.~      In this prospective, single-center randomized trial over 10 weeks, 24 patients with chronic~     kidney disease (CKD) stage III-IV (eGFR 15-59 ml/min) will be randomized to take either~     aliskiren (up to 300 mg per day) or candesartan (up to 16 mg per day) after a two week run-in~     phase where all RAS-blockers are eliminated. The investigators will then employ a novel mass~     spectrometry-based quantification method (after run-in and 10 weeks) to capture the~     concentrations of ten different angiotensin peptides (including angiotensin I and II,~     angiotensin 1-7 and angiotensin 1-5).~      The investigators hypothesize that significant differences exist between angiotensin levels~     in CKD patients with DRI compared to angiotensin receptor blockers. Specifically, the~     investigators expect to determine the regulation of the alternative RAS represented by~     angiotensin 1-7 with proximal versus distal blockade of the system.~      Our data might contribute to a more profound understanding of results from registries and~     clinical trials beyond the clinical effects of RAS blockade. Further, the study's results~     might help to individualize and optimize RAS-blocking therapy strategies in CKD patients.~   "
132942|NCT01827189|"~     Examines staff size and composition of the 496 advanced primary care practices participating~     in CMS's comprehensive primary care initiative, in 7 regions (states or local areas) that~     were selected for the demonstration.~   "
132943|NCT01827176|"~     The purpose of this study is to determine the clinical characteristic of recurrent acute~     rhinosinusitis in children.~   "
132944|NCT01827163|"~     The purpose of this study is to study a new treatment for HER2-positive breast cancer.~   "
132945|NCT01827150|"~     The present proposal investigates the influence of energy drinks on the blood oxygenation~     concentration of the optic nerve on healthy subjects. On a voluntary basis, 15 subjects, man~     or woman, will be selected to undergo this experiment. Many factors can influence the blood~     oxygenation concentration of the optic nerve, which will be measured also during this~     experiment, namely: Intra ocular pressure (IOP), blood pressure, heart rate and systemic~     hemoglobin saturation.~      The subjects will have to be tested twice to test the two conditions of this experiment:~        1. The effect after the intake of a can of Redbull (250 ml)~        2. The difference with the intake of 250 ml of water~      The purpose of this study is to determine if the blood oxygenation concentration of the optic~     nerve varies after having ingested 250 ml of Redbull.~      Our hypothesis are:~        1. The blood oxygenation concentration of the optic nerve measured with OSOME (see detailed~          description below), decreases due to the consumption of the energy drink Redbull~          compared to an equal volume of water.~        2. The IOP measured with iCare tonometer decreases after the consumption of the energy~          drink Redbull compared to an equal volume of water.~        3. The systemic blood pressure, measured with an automatic sphygmomanometer remains~          constant after ingestion of Redbull energy drink or an equal volume of water.~        4. Heart rate, measured with a sphygmomanometer automatic increases after taking a Redbull~          energy drink compared to an equal volume of water.~        5. The rate of systemic hemoglobin saturation measured with a pulse oximeter remains~          constant after the ingestion of a Redbull energy drink or an equal volume of water.~   "
132946|NCT01827137|"~     The purpose of this study is to see if the investigator can help the immune system to work~     against myeloma. Because cancer is produced by the patients own body, the immune system does~     not easily recognize and fight cancer cells. The immune system needs to be trained to do~     this.~      This disease has been selected for this study because the Wilms Tumor 1 (WT1) protein is~     often present in myeloma cells. WT1 is a gene that is involved in the normal development of~     kidneys and other organs. When the WT1 gene becomes abnormal, it can make proteins involved~     in the development of cancer. This study will determine whether the WT1 vaccine causes an~     immune response which is safe and able to keep the myeloma from coming back.~   "
132947|NCT01827124|"~     Intravenous Carbetocin is more efficient than intravenous infusion oxytocin in management of~     placental delivery in 2nd trimester interruption.~   "
132948|NCT01827111|"~     The goal of this clinical research study is to learn if the combination of ipilimumab and~     ABI-007 (abraxane) can help to control metastatic melanoma. The safety of this drug~     combination will also be studied.~      Ipilimumab is designed to increase the immune system's ability to fight cancer.~      Abraxane is designed to stop cancer cells from making new DNA (the genetic material of~     cells). This may stop the cancer cells from dividing into new cells.~   "
132949|NCT01827098|"~     Both methods tested in this study disinfect the non-vital root canals and induce blood clot~     formation inside the root canal. One method places calcium hydroxide inside the root canal~     after disinfection and the blood clot is induced four weeks later.~      The other method performs disinfection and induction of blood clot in one appointment. The~     investigators hypothesize that both methods will obtain the same success rate in eliminating~     infection, increase in root length and canal walls thickness.~   "
132950|NCT01827085|"~     The purpose of the study is to investigate wether the use of the Stortz video laryngoscope~     will render in shorter time for the intubation of obese patients compared with the use of a~     conventional Macintosh laryngoscope.~   "
132951|NCT01827072|"~     Patients diagnosed with Multifocal Motor Neuropathy were confirmed based on the European~     Federation of Neurological Societies/ Peripheral. Nerve Society Guideline. Patients who meet~     all inclusion criteria and do not conflict with the exclusion criteria will receive NPB-01~     (intravenous immunoglobulin) 400mg/kg/day for five consecutive days. Subsequently, patients~     receive NPB-01 1g/kg every 3weeks and evaluate the Medical Research Council（MRC） score and~     the Guy's Neurological Disability Scale（GNDS） et al.~      As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse~     events by one year after the start of the study treatment.~   "
132952|NCT01827059|"~     SUMMARY Rationale: Pulmonary arterial hypertension (PAH) can be a rapidly progressive~     disorder and is associated with a high mortality rate, despite medical intervention. With the~     availability of effective therapy, early disease detection is an important strategic~     objective to improve treatment outcomes. Resting echocardiography is currently the~     recommended screening modality for high-risk population groups. However, it is clear that~     abnormalities in resting hemodynamics (and symptoms) are late sequelae of the pathobiological~     processes that begin in the distal pulmonary arteries. Exercise stress may unmask early~     pulmonary vascular dysfunction, however the definition, clinical significance, and natural~     history of 'exercise PAH' remain undefined. However, based on clinical experience and~     literature the prevalence is estimated at ~ 20%.Treatment with endothelin receptor blockers~     has shown a beneficial influence on the clinical performance in patients with exercise~     induced PAH due to systemic sclerosis and primary pulmonary hypertension. Whether endothelin~     receptor blockers decrease pulmonary pressures and improve clinical outcome in patients with~     exercise induced pulmonary arterial hypertension due to congenital heart disease is unknown.~      Objective: Identify congenital heart disease patients with exercise-induced pulmonary~     arterial hypertension. Analyze changes in pulmonary arterial pressures at peak exercise in~     patients with exercise induced pulmonary arterial hypertension before and after treatment~     with bosentan, compared to placebo.~      Study design: Randomized placebo controlled trial with a study period of 26 weeks.~      Study population: Adult congenital heart disease patients with exercise induced pulmonary~     arterial hypertension (n=40) from the Academic Medical Centre, Amsterdam.~      Intervention: After randomization one group (n=20) receives a 125 mg tablet of Bosentan twice~     daily for 6 months. The other group (n=20) receives placebo for 6 months.~      Main study parameters/endpoints: To determine wether bosentan (endothelin receptor inhibitor)~     decreases mean pulmonary arterial pressure at peak exercise in adult congenital heart disease~     patients with exercise induced pulmonary arterial hypertension. Furthermore the change in~     cardiopulmonary exercise capacity and right ventricular function will be investigated.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: All investigations, blood analysis excepted, are non-invasive and free of risk.~     The burden for the patients mainly consists of the time that is consumed by the~     investigations, namely: history taking + physical examination (15 min); Quality-of-Life-~     score (15 min); laboratory tests (electrolytes, creatinine, urea, albumin and neurohormones,~     troponin T); 12 lead electrocardiogram (10 min); exercise echocardiography (30 min);~     cardiovascular exercise testing (30 min).~      The trial medication has a potential risk of liver damage, which will be monitored regularly~     by laboratory testing of liver transaminases.~   "
132953|NCT01827046|"~     A phase III, randomized, case-controlled, open-label, 500-subject clinical trial of minimally~     invasive surgery plus rt-PA in the treatment of intracerebral hemorrhage (ICH).~   "
132954|NCT01827033|"~     This research is being done to learn about the effects of doing meditation (sitting quietly~     and concentrating) on people's ability to pay attention and be relaxed.~   "
132955|NCT01827020|"~     The purpose of this study is to determine whether subanesthetic ketamine addition to~     lidocaine decreases postoperative pain scores in infiltration anesthesia during rhinoplasty.~   "
134149|NCT01811394|"~     The purpose of this study is to evaluate the safety and feasibility of primary~     hypofractionated irradiation of sacrococcygeal chordoma with carbon ions or protons using the~     raster scan technique.~   "
132957|NCT01826994|"~     Rationale:~      Thoracic complaints, possibly due to a cardiac ischemic cause are a diagnostic challenge in~     general practice. When an underlying ischemic cardiac condition (AMI (acute myocardial~     infarction), UAP (unstable angina pectoris)) is considered, referral from general~     practitioner (GP) to a cardiologist has to take place. However, cardiac analysis in 80% of~     referred patients is negative. To optimize referral decisions of GPs, new and fast~     diagnostics are needed.~      Objective:~      To assess the incremental diagnostic value for AMI of a novel rapid PoC H-FABP-test in~     addition to history taking and physical examination in patients presenting in daily general~     practice with possible AMI. In addition the cost-effectiveness of the test will be evaluated.~      Study design:~      Delayed type cross-sectional diagnostic study.~      Study population:~      Patients presenting to the GP with any new-onset chest complaint, at time of presentation not~     lasting for more than 24 hours, that is considered to be of possible cardiac origin by the~     GP.~      Intervention:~      Point of care Heart Type Fatty Acid Binding Protein test (PoC H-FABP-test), added to usual~     care. PoC H-FABP-testing, by qualitatively measuring H-FABP in one single drop of blood~     obtained by finger prick, is added to normal procedures of consultation and referral decision~     by the GP.~      Main study parameters / endpoints:~      Sensitivity, specificity, positive and negative predictive value of point of care~     H-FABP-testing for AMI, alone as well as part of a clinical diagnostic algorithm, in patients~     with thoracic complaints in general practice. All outcome measures, based on using an~     algorithm and/or point of care H-FABP-testing, will be compared to regular diagnostic~     assessment by the GP without using an algorithm and/or point of care H-FABP-testing.~     Therefore, incremental value of H-FABP-testing and/or a diagnostic algorithm is measured.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness:~      Individual participants will experience low risk, since study participation comprehends~     regular care except for an extra finger prick and possibly collection of one extra venous~     blood sample. For this low amount of disadvantage, the participant will experience no~     advantage either. However, results of the study will possibly be useful for similar patients~     in future.~   "
132958|NCT01826981|"~     The purpose of this study is to evaluate the antiviral efficacy, safety, tolerability of~     combination therapy with sofosbuvir (SOF) containing regimens for the treatment of chronic~     hepatitis C virus (HCV) infection.~   "
132959|NCT01826968|"~     The investigators tested the hypothesis that alveolar recruitment maneuver during cesarean~     section and in women under general anesthesia improves lung compliance and gas exchange. The~     investigators applied recruitment maneuver and positive end expiratory pressure (PEEP) 8~     cmH2O. The maximum alveolar pressure limit (Ppeak)was 45 cmH2O during the recruitment~     maneuver. The primary end point of the study is the improvement of the lung compliance~     measured as volume difference/pressure difference (dv/dp) or ml/cmH2O~   "
132960|NCT01826955|"~     The investigators hypothesized that the pneumoperitoneum with reverse Trendelenburg position~     could alter the rSO2 and early postoperative cognitive function.~   "
132961|NCT01826942|"~     In this study the investigators intend to determine the impact of fractional CO2 laser~     treatment on the edges of a fresh wound during surgical area closure on thin skin (e.g. face,~     hands, arms, thorax, etc.) and on thick skin (abdominoplasty procedure) on scar formation.~     The investigators will also evaluate the effect of shallow fractional laser treatment versus~     deep parameters settings. If effective treatments could be performed at time of surgery, this~     would result in both time and cost saving to the patient and to the healthcare system and~     will improve patient's self-image post surgeries.~   "
132962|NCT01826929|"~     The purpose of this study is to determine whether a multifactorial primary care intervention~     based on chronic models can improve the level of control and reduce the number of hospital~     admissions in patients with ischemic heart disease.~   "
132963|NCT01826916|"~     EDEMA2 is an open-label, Phase 2 dose-ranging study designed to assess the safety and~     efficacy of repeated dosing of DX-88 (recombinant plasma kallikrein inhibitor) in Patients~     with Hereditary Angioedema.~   "
132964|NCT01826903|"~     The purpose of this study is to examine whether the successful perinatal depression~     intervention among mothers (Thinking Healthy Programme, THP) has led to improved~     developmental outcomes in the children 6 years later. Economic and human resources aspects of~     the intervention will also be evaluated to determine overall societal benefits from~     investment in such a program, feasibility of scaling up the intervention and its~     sustainability in the long-term. The primary hypothesis is that children of mothers who~     participated in the THP will have better cognitive outcomes and socio-emotional functioning~     when compared to children of mothers randomized to the control group.~   "
132965|NCT01826890|"~     Many patients admitted to intensive care have heart or lung problems. Patients with these~     conditions often require longer durations of support from breathing machines. Survival and~     long-term recovery are improved if the investigators can remove the breathing support~     quickly. In this study, the investigators will focus on patients with severe lung or heart~     disease to examine whether a particular type of breathing machine (NAVA ventilator) will~     allow us to remove breathing support more quickly and with less need for sedative~     medications, when compared to current practice.~   "
132966|NCT01826877|"~     This phase I trial studies the side effects and best dose of autologous dendritic cells in~     treating patients with metastatic kidney cancer. Vaccines made from a person's tumor cells~     and white blood cells may help the body build an effective immune response to kill tumor~     cells.~   "
132967|NCT01826864|"~     This randomized phase III trial studies sargramostim before sentinel lymph node biopsy to see~     how well it works compared to hypertonic saline before sentinel lymph node biopsy in treating~     patients with melanoma. Biological therapies, such as sargramostim, may stimulate the immune~     system in different ways and stop cancer cells from growing. It is not yet known whether~     sargramostim is more effective than hypertonic saline in treating patients with stage IB-II~     melanoma undergoing sentinel lymph node biopsy.~   "
132968|NCT01826851|"~     Exparel is a new local analgesic (numbing medication) that is intended to be longer acting~     than currently available local analgesics. The purpose of this study is to determine whether~     use of Exparel to numb the nerves along the breastbone after open heart surgery, will~     decrease pain and pain medication use after surgery.~   "
132969|NCT01826838|"~     Radiation and androgen deprivation is a common modality for patients with localized prostate~     cancer. Unfortunately for patients with intermediate to high risk prostate cancer incomplete~     tumor eradication and subsequent relapse occurs in 50-75% of patients. The Src pathway~     appears to be integral to the pathobiology of prostate cancer and may be fundamental to~     radioresistance.~   "
132993|NCT01826513|"~     The purpose of this study is to assess the efficacy and user preference of the Newport~     AutoSet for Her in female obstructive sleep apnea (OSA) patients.~      Efficacy will be evaluated by comparing the apnea and hypopnea index (AHI) and oxygen~     desaturation index (ODI) of the Newport AutoSet for Her algorithm to a standard algorithm.~      User preference will be evaluated by subjective feedback relating to comfort, ease of falling~     asleep, sleep disturbance and feeling of being refreshed.~   "
132970|NCT01826825|"~     The objectives of this pilot study are:~        1. to determine whether a short cognitive test battery administered in the preadmission~          test center can be used to cognitively stratify elderly patients presenting for elective~          surgical procedures.~        2. to evaluate the cost of cognitive screening in the preoperative testing center in terms~          of time and finances.~        3. to evaluate patient perceptions about the use of preoperative cognitive screening and~          their outcome expectations from their surgical procedure.~      Subsequent investigations may evaluate whether preoperative cognitive screening is a~     predictor of postoperative morbidity and mortality in elderly surgical patients and whether a~     short cognitive screen administered in the preadmission testing center could be used to~     identify individuals with baseline cognitive impairments that should be refered for more~     formal cognitive evaluation.~   "
132971|NCT01826812|"~     To assess the reading function impairment in patients with dry eye and to assess the effects~     of reading on the ocular surface.~   "
132972|NCT01826799|"~     Rationale: Sound levels in the Intensive Care Unit are frequently reported to exceed the~     recommended levels. It is plausible to assume that this causes sleep disturbance in the~     patients on the ICU.~      Goals/endpoints: to assess sound pressure levels in 6 different Dutch ICU´s and evaluate the~     effect of higher levels on sleep as perceived by the patient.~      Study design: observational multicenter study~      Study population: adult ICU patients > 18 years old with an expected duration of stay of more~     than 24 hours~      Study parameters/endpoints:~      Primary~        1. To gather information on how Dutch ICUs perform on sound levels~             1. Average sound pressure level~             2. Number of sound peaks~        2. To question patients about their perception of sleep quality (measured by RCSQ)~        3. Causes of elevated sound pressure levels~        4. Identification of the most annoying sounds experienced by the patient~      Secondary~      1) Incidence of delirium measured by CAM-ICU~   "
132973|NCT01826786|"~     The purpose of this study is to evaluate the potential efficacy of JNJ-42165279 in treating~     anxiety disorders through evaluation of brain activation patterns using imaging technology in~     healthy volunteers.~   "
132974|NCT01826773|"~     The study is designed to evaluate how safe and how well an investigational imaging product~     CardioPET™ performs as compared to standard approved imaging products in assessing the~     function of heart muscle in coronary artery disease patients.~   "
132975|NCT01826760|"~     This study was to predict 3-month mortality risk of acute-on-chronic hepatitis B liver~     failure (ACHBLF) on an individual patient level using artificial neural network (ANN) system.~     The area under the curve of receiver operating characteristic (AUROC) were calculated for ANN~     and MELD-based scoring systems to evaluate the performances of the ANN prediction.~   "
132976|NCT01826747|"~     The objective is to test the hypothesis that luteal phase support with vaginal progesterone~     leads to a higher clinical pregnancy rate (primary outcome) and live birth rate (secondary~     outcome) when compared to no luteal phase support in a program of intrauterine insemination~     (IUI) after controlled ovarian stimulation with gonadotrophins. Additionally, the length of~     the luteal phase will be recorded (secondary outcome) in order to detect luteal phase~     defects/insufficiencies in the absence of luteal phase suppletion as well as luteal phase~     prolongation in case of luteal phase support which may be a burden for the patients waiting~     for the outcome of the treatment.~   "
132977|NCT01826734|"~     Background Because dacryoliths occur at low frequency, few studies have focused on their~     composition.~      The investigators aimed to present findings from morphological, chemical, and mineralogic~     analysis of 86 dacryoliths.~      Methods The team studied 86 dacryoliths obtained during 832 dacryocystorhinostomies (DCR)~     performed for postsaccal obstruction. The samples were analyzed with atomic infrared~     spectrometry (80 samples), amino acid analysis (17 samples), scanning electron microscopy,~     and an electron microprobe with an energy dispersive detector (7 samples).~   "
132978|NCT01826721|"~     Solid organ transplant recipients (SOTR) must follow complex medication regimens and require~     a substantial amount of education for effective self-management. The current standard of care~     for post-transplant medication teaching is a Self Medication education program conducted in~     hospital by the pharmacist. The Transplant Medication Information Teaching Tool (TMITT) is a~     web-based e-learning tool for SOTR developed at the Toronto General Hospital. The ability to~     control the content, sequence, pace and timing of education in order to achieve personal~     learning objectives, as well as the opportunity for ongoing review and reinforcement of~     information, may be an attractive, convenient and effective teaching modality.~      SOTR will be randomly assigned to receive the standard of care or the standard of care plus~     the TMITT intervention. Primary objectives are to compare patient satisfaction and medication~     knowledge between the two groups at baseline and 3 months using modified versions of~     previously published questionnaires. Medication adherence as measured by a multidimensional~     approach including both subjective and objective components, will also be compared at 3~     months. Our hypothesis is that an education strategy that includes both the standard~     pharmacist teaching followed by a tailored online e-learning intervention post-discharge will~     lead to improved patient satisfaction, knowledge and medication adherence.~   "
132987|NCT01826591|"~     Genomics research is advancing rapidly, and links between genes and obesity continue to be~     discovered and better defined. A growing number of single nucleotide polymorphisms (SNPs) in~     multiple genes have been shown to alter an individual's response to dietary macronutrient~     composition. Based on prior genetic studies evaluating the body's physiological responses to~     dietary carbohydrates or fats, the investigators identified multi-locus genotype patterns~     with SNPs from three genes (FABP2, PPARG, and ADRB2): a low carbohydrate-responsive genotype~     (LCG) and a low fat-responsive genotype (LFG). In a preliminary, retrospective study (using~     the A TO Z weight loss study data), the investigators observed a 3-fold difference in~     12-month weight loss for initially overweight women who were determined to have been~     appropriately matched vs. mismatched to a low carbohydrate (Low Carb) or low fat (Low Fat)~     diet based on their multi-locus genotype pattern. The primary objective of this study is to~     confirm and expand on the preliminary results and determine if weight loss success can be~     increased if the dietary approach (Low Carb vs. Low Fat) is appropriately matched to an~     individual' s genetic predisposition (Low Carb Genotype vs. Low Fat Genotype) toward those~     diets.~   "
132988|NCT01826578|"~     This study is about the evaluation of which benefits single port laparoscopic myomectomy has~     in the perspective of cosmetics and patient satisfaction.~   "
132979|NCT01826708|"~     For every child with developmental delay, the investigators do a constitutional karyotype.~     This karyotype can reveal an apparently balanced chromosomal rearrangement (no visible loss~     or gain of genetic material), such as a translocation between two or more chromosomes of~     accidental occurrence (not transmitted by parents). However, an apparently balanced~     translocation does not explain the phenotype of the child. Among the hypotheses that could~     explain the child's symptoms, there is the possibility of another chromosomal abnormality at~     the translocation breakpoints, another defect elsewhere on the chromosomes or gene disruption~     at or near the breakpoints. Because the resolution of a constitutional karyotype is limited,~     these microanomalies can go undiagnosed. The goal of this study is to look for a microanomaly~     on a chromosome using a technology of higher resolution than that of the conventional~     karyotype. The proposed study uses DNA microarray technology on DNA extracted from blood~     lymphocytes to perform high-resolution analysis of all chromosomes to search for an~     unbalanced microrearrangement (such as loss or gain of chromosomal material). If no~     microrearrangement is found, the investigators will pursue by looking for a gene disruption~     defect at or near the breakpoints involved in the translocation. This will be done by first~     isolating the chromosomes involved in the translocation by flow cytometry and then~     hybridizing each of the isolated chromosomes on a new microarray. The purpose of this study~     is to find a possible cause to explain the phenotype (microrearrangement or gene disruption).~   "
132980|NCT01826695|"~     Fibromyalgia is a chronic illness characterised by persistent,widespread muscle pain with~     generalised hyperalgesia and allodynia. It can be accompanied by other concomitant symptoms~     like fatigue, sleep disturbances, musculoskeletal disorders, distress and psychological~     disorders. This condition is very prevalent. It has been reported to be about 2-5% of the~     general global population.~      Fibromyalgia have been reported to have neurodynamic disorders. The purpose of this~     prospective study was to examine the combined effects of soft tissue mobilization and nerve~     slider neurodynamic technique on pain and pressure sensitivity in women with fibromyalgia.~   "
132981|NCT01826682|"~     Chronic Obstructive Pulmonary Disease (COPD) is a chronic condition. Its evolution can be~     aggravated in some periods by an increase of the symptoms (above all the cough, the dyspnoea~     and the quantity of sputum purulence). This is known as exacerbation and it is the most~     frequent cause of hospital stay, urgences services and death in COPD. A physiotherapy program~     is carrying out in patients attending to the Hospital because of an exacerbation.~      The hypothesis of this study is that a physiotherapy program added to a medical treatment~     increase the ventilatory function, the physiques variables, decrease depression and anxiety~     and improve the quality of life. Additionally, it is going to be assessed the effect of~     physiotherapy in time using phone calls and visits to the patient's home.~   "
132982|NCT01826669|"~     The study hypothesis is chest wall muscle stretching increase distribution of volume~     variation of thoracoabdominal wall and reduce electromyographic activity of respiratory~     muscles in patients with Chronic Obstructive Pulmonary Disease.~   "
132983|NCT01826656|"~     Both the pathogenesis and the treatment of osteoporosis may potentially interfere at~     different levels on the multi-stage complex cascade of events involved in bone~     healing/regeneration. To our knowledge no human studies have been performed to clarify the~     potential effect of osteoporosis on post-extraction alveolar healing. The primary outcome of~     the study is to compare alveolar bone changes in width and height 3 months after tooth~     extraction in 10 post-menopausal osteoporotic women and 10 post menopausal non osteoporotic~     women by the use of cone-beam computer tomography (CBCT) images. The secondary outcomes~     considered are: clinical changes in the external contour of the ridge and periodontal~     parameters in the neighbouring teeth after a tooth extraction and 3 months later. In addition~     the accuracy of panoramic morphometric indexes in detecting osteoporosis will be measured.~   "
132984|NCT01826630|"~     The primary objective of this protocol is to acquire pilot data for a larger study to test~     the following hypothesis: Treatment of the hands of patients with chronic hand~     dermatitis/atopic dermatitis with CLn BodyWash, a novel gel wash cleanser currently marketed~     as a cosmetic product containing a dilute concentration of less than 0.01% sodium~     hypochlorite and less than 0.005% concentration as it is lathered, will result in a~     statistically significant reduction in the number of skin fauna present on the hands of these~     patients compared to treatment of such patients with traditional wash used clinically such as~     Cetaphil Daily Facial Cleanser.~   "
132985|NCT01826617|"~     This study will identify significant clinical parameters and individual risk factors related~     to certain prostate disease (BPH, prostatitis and prostate cancer). With the identified~     important correlations, a locally generated bias free nomogram will be constructed for~     predicting prostate biopsy outcome among Asian men with indications for prostate biopsy.~     While this study will evaluate the accuracy and predictive value of this novel prostate~     disease nomogram.~   "
132986|NCT01826604|"~     The purpose of this study is to investigate the effects of the Alexis O C-section retractor~     in obese patients (BMI ≥30 kg/m2) who undergo Cesarean sections. Patients will be randomized~     to the use of the Alexis retractor during Cesarean section (treatment group) or the use of~     traditional hand-held retractors (control group). We will determine if there is any~     difference in surgical site infection or wound disruption rates. We will also determine if~     there is a difference in the duration of surgery or length of time from skin incision to~     delivery of the infant, change in hemoglobin, estimated blood loss, and postoperative length~     of stay, intra-operative or postoperative anti-emetic requirements, need for hospital~     readmission or emergency room visits, or other complication rate between the two groups.~   "
132989|NCT01826565|"~     To evaluate the efficacy of rotational technique in the insertion of i-gel~   "
132990|NCT01826552|"~     The purpose of this multicenter, randomized, open label, parallel arm study whether the~     newest 3rd generation stent - Orsiro hybrid sirolimus-eluting stent is noninferior to the~     newest 2nd generation stent - Resolute Integrity zotarolimus-eluting stent in terms of 9~     months in-stent late lumen loss. 345 Korean patients with a wide variety of coronary heart~     disease will be enrolled to this all-comers trial to give definite answer to the above~     hypothesis that is urgently needed.~   "
132991|NCT01826539|"~     As the donor nerve attached with the flap, the dorsal branch of the digital nerve and the~     dorsal digital nerve is commonly used for finger pulp reconstruction.This study compares two~     donor nerves: the dorsal branch of the digital nerve and the dorsal digital nerve.~   "
132994|NCT01826500|"~     The five proteins of the ITI (Inter-α-trypsin inhibitor) family, are essential components of~     the extracellular matrix, the dynamics of which they participate in the processes of cellular~     differentiation and proliferation. I. The ITIH1, ITIH2, ITIH3 and ITIH4 genes seem to be~     overwhelmingly expressed in the liver, this organ secreting then the corresponding proteins~     in the general circulation. The only data on ITIH5 indicate that this gene is poorly~     expressed in the liver and that the major source of its expression is the placenta. In the~     context of genetic studies on the syndrome of Mayer-Rokitansky-Küster-Hauser (congenital~     aplasia of the uterus and vagina), the investigators have shown the involvement of ITIH5 and~     implemented validation experiments of this gene in mice. The investigators have shown that~     the production of ITIH5 by the uterus varies greatly depending on the physiological state of~     this organ, especially during pregnancy and the estrous cycle. The investigators also found~     that most of the production ITIH5 was located in the uterus. Therefore, the serum dosage of~     ITIH5 could be used clinically as a new biological marker specific to the uterus. This~     non-invasive biological marker could thus assist in the diagnosis and the understanding of~     uterine pathologies. ITIH5 rate being correlated to endometrial proliferation, its dosage~     could be an early and non-invasive marker of endometriosis. The peak of production of ITIH5~     by the uterus at the time of embryo implantation window indicates that the assay could~     provide a better assessment of endometrial receptivity to embryo. It then could be a hand~     tool of diagnosis in some cases of early repeated miscarriages, and secondly, a prognostic~     tool for embryo implantation in the context of in vitro fertilization.~      The investigators conducted an initial feasibility study on the serum dosage of ITIH5, which~     was approved by the ethics committee of the University Hospital of Rennes. This first step~     has been validated. Now, the project is to perform a quantitative analysis of ITIH5 and to~     correlate clinical and biological data of relevant pathological and physiological situations.~     This project was the subject of a national and international patents of which the University~     Hospital of Rennes is promoter.~   "
132995|NCT01826487|"~     Dystrophinopathy is a disease continuum that includes Duchenne muscular dystrophy, which~     develops in boys. It is caused by a mutation in the gene for dystrophin, a protein that is~     important for maintaining normal muscle structure and function. Loss of dystrophin causes~     muscle fragility that leads to weakness and loss of walking ability. A specific type of~     mutation, called a nonsense (premature stop codon) mutation is the cause of dystrophinopathy~     in approximately 10-15% of boys with the disease. Ataluren is an orally delivered,~     investigational drug that has the potential to overcome the effects of the nonsense mutation.~     The main goal of this Phase 3 study is to evaluate the effect of ataluren on walking ability.~     The effect of ataluren on physical function, quality of life, and activities of daily living~     will be evaluated. This study will also provide additional information on the long-term~     safety of ataluren.~   "
132996|NCT01826474|"~     The purpose of the study is to see whether PRO045 is safe and effective to use as medication~     for Duchenne Muscular Dystrophy (DMD) patients with a mutation around location 45 in the DNA~     for the dystrophin protein.~   "
132997|NCT01826461|"~     This study will compare the safety and efficacy of three test article foams (PDI-192 0.1%~     Foam, PDI-192 0.15% Foam, and Vehicle Foam) such that a final commercial product may be~     selected for future development.~   "
132998|NCT01826448|"~     The purpose of this research study is to test the safety of an investigational new drug~     called PLX3397 when used in combination with Vemurafenib (Zelboraf™) at different dose~     levels. Vemurafenib has been approved by the United States Food and Drug Administration~     (FDA)/European Medicines Agency (EMA) for the treatment of a specific category of~     unresectable or metastatic melanoma.~   "
132999|NCT01826435|"~     The study team is proposing a single arm intervention to test the effect of an electronic~     intervention on medication use among individuals with a prescription for hypertension/high~     blood pressure. The investigator proposes that technology like text messaging, email, web~     applications and mobile apps with proven, nurse intervention scripts, will lead to~     significant, cost-effective improvements in hypertension medication use.~   "
133000|NCT01826422|"~     The purpose of this study is to evaluate the effect of docosahexaenoic fatty acid and~     eicosapentaenoic fatty acid supplementation for six months on the inflammation state as well~     as the process of muscular regeneration and the metabolic disorders like obesity and insulin~     resistance in patients with Duchenne muscular dystrophy (DMD) and Becker muscular dystrophy~     (DMB) compared to those receiving placebo.~   "
133001|NCT01826409|"~     This study was conducted to investigate the effects of daily supplementation of fermented red~     ginseng (FRG) on glycemic status in subjects with impaired fasting glucose (IFG) or type 2~     diabetes.~   "
133002|NCT01826396|"~     In the current treatment of colon cancer, the definition of locally advanced colon cancer~     (LACC) is controversial, and the clinical trial evidence which support treatment for LACC is~     not clear. Irinotecan (CPT-11) combined with fluoropyrimidine (5FU, capecitabine) is main~     chemotherapy regimen for patients with advanced colorectal cancer. Whether this regimen also~     could be effectively applied for patients with locally advanced colon cancer? It is worthy of~     clinicians to conduct research. In recent studies, the literature indicated that the the~     uridine diphosphate glucuronide transfer enzyme (UGT1A1) is an important metabolic enzymes~     associated with drug metabolism of CPT-11. The gene polymorphism of UGT1A1 is related to~     delayed diarrhea and neutropenia caused by irinotecan. Irinotecan dose-exploration study~     found that the maximum tolerated dose for irinotecan in patients with UGT1A1*28 homozygous~     variant genotypes was significantly lower compared with the wild genotype. The studies based~     on Asian patients suggested that the gene variant of UGT1A1*6 also have similar impacts. At~     present, the studies of irinotecan dose adjustment based on the UGT1A1 gene polymorphisms has~     not yet come to the consistency of conclusions. The frequency of UGT1A1 gene polymorphisms~     between different races is significant different, irinotecan dose exploratory study based on~     Chinese patients has not been carried out.~      This study focus on prospectively adverse reactions, optimal efficacy and R0 resection rate~     of the patients with LACC who treated by dose-adjusted irinotecan based on the genotypes of~     UGT1A1.~   "
133003|NCT01826383|"~     This study sets out to compare the effectiveness of a parent pain management coaching video~     that is 5-minutes in length. The investigators will be comparing an active-video to a~     placebo-video of equal length (and identical formatting). Participants will be 6 or 18 month~     infants undergoing routine immunization. The investigators hypothesize the active video will~     result in a lowering of infant pain expressed post-immunization (3 minutes) and the increase~     in the parental use of distraction, physical comfort, and rocking.~   "
133004|NCT01826370|"~     This is a prospective, non-interventional, open label, multi center, post marketing~     surveillance study designed to assess the safety, tolerability and efficacy of Linagliptin~     among Filipino patients with type 2 Diabetes Mellitus (DM) within the study duration of 24~     weeks.~   "
133016|NCT01826214|"~     The study will evaluate the efficacy, safety and tolerability of two dosing schedules of~     LDE225 in patients with relapsed/refractory acute leukemia or elderly patients with untreated~     acute leukemia.~   "
133005|NCT01826357|"~     The metabolic syndrome (MetS) is a cluster of clinical indices that signals increased risk~     for cardiovascular disease and Type 2 diabetes. Women with polycystic ovary syndrome (PCOS)~     were associated with MetS and insulin resistance. Cluster analysis was a useful tool for~     identifying groups of women sharing similar metabolic risk factor patterns. Oligomenorrhea,~     hyperandrogenism and polycystic ovary morphology were the three major components of PCOS.~     Obesity is a main risk factor in metabolic syndrome. the investigators are interesting to~     evaluate the relationship between risk of metabolic syndrome and their clinical and/or~     biochemical characteristics in women with reproductive age.~      Design: Retrospective study; medical records reviewed. Participants and setting: The~     investigators retrospectively reviewed the medical records of female patients who visited our~     Reproductive Endocrinology Clinic from Jan. 1, 2009 to Jun. 31, 2012.~   "
133006|NCT01826344|"~     This is a multicentre, prospective, observational post-market registry (follow-up 1 month, 1~     year, 2 years, 3 years, 4 years and 5 years) to monitor the post-market clinical safety and~     effectiveness of the Vascutek AnacondaTM Custom Fenestrated Stent Graft in patients with a~     short infrarenal neck of <15mm or juxta-renal abdominal aortic aneurysms who, in the opinion~     of the treating physician, are anatomically suitable for the AnacondaTM Custom Fenestrated~     Stent Graft and for whom a customised medical device is required.~   "
133007|NCT01826331|"~     One of the most important debates in the field of disease prevention is whether financial~     incentives should be contingent on participation in evidence-based programs for smoking~     cessation or on actual outcomes, like prolonged abstinence. This study can fill a major~     knowledge gap in this debate, which is the lack of any population trial that compared the~     impacts of outcomes- and participation-based incentives in a population of smokers. This~     research can help policy makers and health service providers choose the incentives approach~     that provides the most effectiveness, cost-effectiveness and cost-savings for entire~     populations of smokers.~   "
133008|NCT01826318|"~     This study assessed the impact of a task-focusing strategy on perceived stress levels and~     performance during a simulated CPR scenario.~   "
133009|NCT01826305|"~     In this study we plan to compare the efficacy of independent exercises performed by the~     patients at home to formal rehabilitation therapy following primary total knee replacement.~     Patients will be randomized to these two cohorts at enrollment into the study and followed~     prospectively. Patients randomized to the formal rehabilitation cohort will receive a~     prescription for therapy for twelve weeks. Patients randomized to the independent exercise~     cohort will receive online access to a twelve-week protocol of exercises to perform at home~     to strengthen and improve function of the replaced joint.~      At enrollment, a baseline evaluation will be conducted to capture demographics, height,~     weight, primary diagnosis, medical comorbidities, and social supports as well as completion~     of the selected outcome measure, American Knee Society (AKS) Score, Knee and Osteoarthritis~     Outcome Score (KOOS). Secondary outcomes will include the measurement of health status with~     use of the Short Form-12v2 (SF-12v2) and activity level with the University of California,~     Los Angeles (UCLA) Activity Score. At the twelve-week, six-month and twelve-month follow-up~     visits, the study subjects will complete the KOOS, SF-12v2, and UCLA Activity Score~     questionnaires. Statistical analysis will be performed to compare the outcomes between the~     two cohorts.~      Hypothesis:~      There will be no difference in outcomes between formal rehabilitation and independent~     exercises at twelve months after primary total knee replacement surgery using the American~     Knee Society (AKS) Knee Score.~   "
133010|NCT01826292|"~     The investigators are conducting a retrospective, cross-sectional chart review of patients~     who underwent an anesthetic administered by an anesthesiologist in the University of~     California Davis main operating rooms and were transferred to the main post anesthesia care~     unit between January 1, 2012 and March 31, 2012. The investigators are excluding patients~     less than 18 years of age, patients transferred to the intensive care unit, and patients for~     whom data is not reported. Our aim is to report the incidences patient characteristics, as~     well as anesthetic and surgical techniques, and the associations these factors may have with~     the outcome of patient length of stay in the PACU.~   "
133011|NCT01826279|"~     The purpose of this study is to investigate potential metabolic effects of resveratrol in~     morbidly obese women undergoing gastric bypass surgery.~      The investigators hypothesize that resveratrol will:~        -  Decrease hepatic very-low-density-lipoprotein-triglyceride (VLDL-TG) secretion~        -  Decrease hepatic and adipose tissue VLDL-TG uptake~        -  Increase insulin sensitivity~      The investigators will look at changes in:~        -  Lipid turnover (VLDL-TG kinetics, palmitate kinetics,calorimetry)~        -  VLDL-TG uptake in different tissues (subcutaneous femoral adipose tissue, subcutaneous~          abdominal adipose tissue, visceral adipose tissue and liver tissue)~        -  Insulin sensitivity (glucose kinetics during hyperinsulinaemic euglycaemic clamp)~        -  Regulation of liver fat handling~        -  Lipoprotein lipase activity and fat cell size (abdominal and femoral adipose tissue)~   "
133012|NCT01826266|"~     PER977 monotherapy and co-administration following 60 mg edoxaban will have an acceptable~     safety and tolerability profile with no impact on pro-coagulant biomarkers. A dose of PER977~     that reverses the effects of edoxaban on the pharmacodynamic (PD) biomarkers (point of care~     prothrombin time [PoC-PT]), and/or secondary biomarkers (thromboelastography reaction time~     [TEG-R]) will be identified.~   "
133013|NCT01826253|"~     Fluid expansion during cardiocirculatory insufficiency was helped by cardiac output~     monitoring. However, the goal of fluid expansion was to increase the oxygen delivery, which~     consider cardiac output, but also Haemoglobin which decrease during a fluid challenge. The~     maximalization of cardiac output could decrease the oxygen delivery if the haemodilution was~     too wide. The aim of this study was to describe the oxygen delivery during a fluid expansion~     conducted for cardiac output maximalization, following actual guidelines.~   "
133014|NCT01826240|"~     The purpose of this study is to combine and adapt Mindfulness-Based Cognitive Therapy (MBCT)~     + Safety Planning Intervention (SPI) for individuals with suicidal behavior and to determine~     its feasibility, acceptability, safety and preliminary effectiveness. An exploratory aim is~     to collect data on the cognitive changes underlying treatment gains.~   "
133015|NCT01826227|"~     The purpose of this study is to see if Positron Emission Tomography (PET) probes make it~     easier for your surgeon to find cancer and remove it during your surgery. A PET probe is a~     wandlike device that can detect radioactivity.~   "
133019|NCT01826175|"~     Subjects with acute coronary syndromes scheduled for cardiac catheterization will be enrolled~     in this study. Subjects that are to be treated clinically with coronary artery stenting will~     be randomized to receive a loading dose of clopidogrel versus ticagrelor after diagnostic~     angiography but prior to stenting. Optical coherence tomography (OCT) will be performed after~     stenting and the presence of blood clots inside the new stent will be measured and compared~     between the groups.~   "
133020|NCT01826162|"~     Gut microbiota is being increasingly recognized as an important factor in fat distribution,~     insulin sensitivity and glucose and lipid metabolism. Accordingly, the intestinal microbiota~     could play an important role in the development of obesity and type 2 diabetes mellitus. The~     role of gut-derived short-chain fatty acids (SCFA), the formation of which is enhanced by~     microbial fermentation of fibre, is still controversial. At the present time, our~     understanding of the effects of SCFA on human metabolism (in gut or systemically) is still~     limited. The investigators hypothesize that the differential availability of SCFA impacts~     human metabolism differently.~      In this placebo controlled, double-blind, randomized crossover pilot study the investigators~     will validate in overweight/obese healthy male volunteers whether rectal administration of~     SCFA is a good model for studying the acute metabolic effects of SCFA. For this, it will be~     investigated if site of administration (in distal or proximal colon) of SCFA differentially~     affects parameters of substrate and energy metabolism and to test the duration of short-term~     effects of SCFA administration.~   "
133021|NCT01826149|"~     The purpose of this study is primarily to determine the effects of propofol at different~     concentration on the mitral valve annulus by using Tissue Doppler Imaging~   "
133022|NCT01826136|"~     Postoperative airway clearance and recovery of pulmonary function after lung resection is~     critical in patients undergoing pulmonary resection surgery. The investigators hypothesized~     that vibratory positive expiratory pressure using the Acapella device may improve pulmonary~     function recovery in patients undergoing video-assisted thoracoscopic lung resection surgery.~   "
133023|NCT01826123|"~     Recently, the investigators study group showed in a mono center study that Point of Care~     (POC) based hemotherapy may reduce transfusion rates of allogenic blood products in~     perioperative care of coagulopathic cardiac surgery patients. The investigators aim to verify~     the obtained results by conducting this multicenter study.~   "
133024|NCT01826110|"~     The purpose of this study is to investigate the radiotracer [11C] PIB in participants with~     probably Alzheimer's Disease (AD) and healthy age-matched controls.~   "
133025|NCT01826097|"~     Can a commercially available vibrating chair increase the number of urothelial cells in a~     urine sample of healthy participants non-invasively? The investigators plan is participants~     will alternate 15 minutes of drinking eight fluid ounces of water and 15 minutes of sitting~     in the vibrating chair for one hour. The control group will alternate 15 minutes of drinking~     eight fluid ounces of water and 15 minutes of sitting in a non-vibrating chair for one hour.~     Then, urine samples will be collected and examined for urothelial cell concentration for both~     groups.~   "
133026|NCT01826071|"~     The purpose of this study is to compare three different treatments for these types of lower~     extremity apophysitis- Osgood-Schlatter syndrome (OSS), Sinding-Larsen and Johansson syndrome~     (SLJ), or Sever's disease.~      The investigators hypothesize that adolescents who perform a home exercise program (HEP)~     consisting of active elongation exercises will have decreased pain and earlier return to~     sports and activities as compared to those who perform a HEP that consists of static~     stretching exercises or those who use symptomatic treatment with ice, acetaminophen or NSAIDs~     and activity modification.~   "
133027|NCT01826058|"~     Metastatic epidural spinal cord compression (MESCC) is a frequent oncologic emergency that~     requires to be treated promptly. Although direct decompressive surgery is the most effective~     treatment, surgery is only used in selected patients because most patients have a poor~     overall condition and short life expectancy. Radiation therapy (RT), therefore, is the most~     commonly used for patients with MESCC, but conventional RT alone can achieve modest~     neurologic outcomes.~      The hypothesis to use stereotactic body radiation therapy (SBRT) for MESCC is that the rapid~     decompression of epidural mass, durable local control and subsequently improved neurologic~     outcomes compared to conventional RT are expected when MESCC is treated with SBRT.~   "
133028|NCT01826045|"~     The purpose of this study is to determine the efficacy and the safety of PGA(Poly-gamma~     Glutamic Acid) for the the fertile women with Cervical Intraepithelial Neoplasia (CIN1).~   "
133029|NCT01826032|"~     In the near future more than 20% of the European population will be over 65 years old and the~     prevalence of obstructive sleep apnea (OSA) in this aged population is known to be higher~     than 50%. OSA is a risk factor for cognitive dysfunction in middle-aged subjects, but the~     relationship between cognitive impairment and sleep breathing disorders (SBD) in the elderly~     has scarcely been observed.~      The aim of this study is to investigate cognitive performance in elderly OSA patients, the~     corresponding brain morphology changes and biological markers and their reversibility with~     continuous positive airway pressure (CPAP) treatment.~   "
133030|NCT01826019|"~     The overall objective of the HOPE-4 Phases (HT and CVD) is to develop, implement and evaluate~     an evidence-based, contextually appropriate programme for cardiovascular disease (CVD) risk~     assessment, treatment and control involving: (1) simplified algorithms implemented by~     non-physician health workers (NPHW) and supported by e-health technologies (tablets~     programmed with decision and counselling support software); (2) initiation of evidence-based~     cardiovascular (CV) medications and (3) treatment supporters to optimize long-term medication~     and lifestyle adherence.~   "
133031|NCT01826006|"~     The occurrence of no-reflow phenomenon after recanalization of the infarct related artery in~     acute myocardial infarction is described in up to 40% of cases. This event is associated with~     a worse prognosis at follow up and an unfavourable left ventricular remodelling. Two main~     pathogenetic mechanisms cause no-reflow: distal embolization, ischemia-reperfusion injury and~     individual susceptibility. In such a context, Excimer Laser (EL) may play an important role~     in order to reduce the rate of microvascular obstruction.~      Thus, in this randomized study we will assess the effect of EL versus Manual Thrombus~     Aspiration for ST elevation MI using ST segment resolution on standard 12 leads ECG as~     primary endpoint of myocardial reperfusion.~   "
133032|NCT01825993|"~     The investigators would study the control of postoperative pain with peridural catheter,~     morphine PCA ev or Transabdominal block.~   "
133035|NCT01825954|"~     The purpose of this study is to test the safety and efficacy of a noninvasive cortical~     electrostimulation therapy known as Reduced Impedance Noninvasive Cortical~     Electrostimulation (RINCE) in the management of fibromyalgia. Patients who meet the 1990~     American College of Rheumatology criteria for fibromyalgia will receive up to 24 RINCE~     treatments delivered by a medical device called NeuroPoint. Approximately 45 fibromyalgia~     patients will be randomized into one of three study groups. One of these groups will receive~     sham treatment, meaning they will receive no treatment at all, while the remaining two groups~     will receive different amounts of RINCE therapy. The study's primary outcome measure will be~     the patient's change from baseline in self-reported 24-hour average pain intensity. The~     study's hypothesis is that there will be a difference between treatment groups in primary~     outcome measure.~   "
133036|NCT01825941|"~     Parenteral diphenhydramine is commonly used as adjuvant therapy for acute migraine despite~     the fact that data supporting this practice do not exist. The investigators propose a~     randomized double blind study to test the hypothesis that 50mg of intravenous~     diphenhydramine, when added to standard migraine therapy, will result in a greater rate of~     sustained headache relief than standard migraine therapy alone. For this study, standard~     migraine therapy will be 10mg of intravenous metoclopramide. Sustained headache relief is~     defined as achieving a headache level of mild or none within two hours and maintaining a~     level of mild or none for 48 hours. Patients who present to the Montefiore emergency room~     (Bronx, NY) with an acute migraine will be approached for participation. They will be~     screened for medication contra-indications and non-migraine etiologies of headache. The study~     will be randomized. Assignment will be concealed. Participants and researchers will be~     blinded. Efficacy outcomes and adverse events will be assessed every half hour for two hours~     in the ED and by telephone 48 hours after medication administration. A sample size~     calculation, based on pilot data, revealed the need for 374 participants. An interim analysis~     will be performed after 200 participants have been enrolled with the goal of assessing for~     lack of conditional power.~   "
133037|NCT01825928|"~     Methamphetamine substance use is common worldwide. No approved pharmacologic treatments for~     methamphetamine dependence exist. paliperidone are Second generation antipsychotics，and have~     effects of blocking dopamine2(D2) and 5-hydroxytryptamine 2A(5-HT) receptors~     neurotransmitters.To determine whether mirtazapine would reduce methamphetamine use among~     methamphetamine addicts.~   "
133038|NCT01825915|"~     Observational studies suggest faster recovery and quicker return to normal activities~     following laparoscopic supracervical hysterectomy (LSH which involves removal of the body of~     the womb but conservation of the neck of the womb or cervix) compared with laparoscopic~     hysterectomy (LH in which both the body and neck of the womb are removed) in women with~     benign uterine disease. Data from the only randomised controlled trial (RCT) on the topic~     does not support this observation.~      The investigators set out to investigate the feasibility of a double blind RCT comparing~     post-operative recovery following LH with that following LSH.~      The investigators set out to recruit 50 participants from a single gynaecological surgeon's~     caseload. Web based randomisation was carried out at the time of study laparoscopy. Surgery~     was performed using a standardised technique.~      Participants and the data handler were blinded to treatment allocation (double blind study~     where neither the patient nor the surgeon have knowledge of treatment group allocation at the~     time of questionnaire analysis).~      Primary outcome is feasibility of recruitment to the study. The null hypothesis for this~     study is that 'a double blind, randomised controlled comparison of recovery following~     laparoscopic hysterectomy with recovery following laparoscopic sub-total hysterectomy' is not~     feasible.~      Secondary outcomes included validated post-operative recovery and mood questionnaires at~     baseline, prior to discharge and at weekly intervals for 12 weeks. Validated questionnaires~     regarding pelvic floor function and sexual function will be assessed at baseline, 6 weeks and~     6 months.~      The findings of the feasibility study will inform the power calculation for a planned~     definitive study ( the magnitude of the differences found between the 2 arms of the~     feasibility study will allow calculation of the total number of participants required in a~     definitive study to allow demonstration of statistically significant differences in~     outcomes).~   "
133039|NCT01825902|"~     This pilot trial studies fluorine F 18 fluorothymidine (18F-FLT) positron emission tomography~     and diffusion-weighted magnetic resonance imaging in planing surgery and radiation therapy~     and measuring response in patients with newly diagnosed Ewing sarcoma. Comparing results of~     diagnostic procedures done before and after treatment may help doctors predict a patient's~     response and help plan the best treatment.~   "
133040|NCT01825889|"~     The purpose of this study is to measure how much of the study drug, evacetrapib, gets into~     the blood stream and how long it takes the body to get rid of it when given to participants~     with severe renal (kidney) impairment compared to participants with normal renal (kidney)~     function. This study will last approximately 8 weeks.~   "
133041|NCT01825876|"~     All study participants will receive both warfarin and a study drug called evacetrapib. The~     main purpose of this study is to look at how much warfarin gets into the blood stream and how~     long it takes the body to get rid of warfarin when given both with and without evacetrapib.~     Another purpose is to evaluate the effectiveness of warfarin therapy to prevent blood clots~     when given with evacetrapib by measuring the time it takes for blood to clot and comparing it~     to an average of the international normalized ratio (INR). INR measures the time it takes for~     blood to clot and compares it to an average.~      The study will last approximately 5 weeks, not including screening.~   "
133042|NCT01825863|"~     Acute appendicitis is a common disease and usually occurs within the ages of 10-30 years~     old. Ten percent of the population will get this disease during a lifetime. At Bispebjerg~     hospital it is one of the most common acute surgeries performed. Though at Bispebjerg~     hospital the surgery is only performed on adults as there is no pediatric ward. The surgical~     technique is primarily laparoscopic surgery, where the patients have their appendix removed~     while in general anaesthesia. During the last three years Bispebjerg hospital has had an~     average of 287 patients per year undergoing laparoscopic surgery. From January to the~     September 2012 a total of 211 patients have had the operation, with 29% having the operation~     performed during daytime, 48% in the evening and 22% at night. Open appendectomy is only~     performed in cases where laparoscopic surgery is impossible, this is often due to adhesions,~     scar tissue from former abdominal surgery or peritonitis. The scars from laparoscopic surgery~     are usually smaller than that from an open appendectomy, but it gives the patient three~     smaller scars divided on three abdominal quadrants instead of one larger scar on one~     quadrant.~      The investigators want to conduct a clinical trial with fifty six patients undergoing~     laparoscopic surgery due to acute appendicitis. The investigators want to find out if it is~     possible to improve the post-operative pain management within this very large group of~     patients undergoing acute surgery. In detail, the investigators wish to explore whether the~     use of the BD-TAP blockade in the abdominal wall on patients undergoing laparoscopic surgery~     due to acute appendicitis, can anesthetize the patients completely or partially, so they can~     avoid morphine intake completely or partially during the post-operative phase (12-24 hours).~     The research project will be a randomized, double-blinded, controlled clinical trial.~   "
133043|NCT01825850|"~     The objective of the study is to investigate the drug interaction between Gemigliptin and~     Irbesartan by comparing pharmacokinetics of Gemigliptin and Irbesartan administered~     concomitantly and each alone in healthy male subjects.~   "
133114|NCT01824927|"~     Patients having cataract extraction in the second eye under topical anesthesia with monitored~     anesthesia care often report increased pain and awareness relative to the first surgery in~     the fellow eye, despite similar operative and anesthetic conditions. The purpose of this~     study is to investigate the pathogenesis of this phenomenon.~   "
133045|NCT01825824|"~     The standard treatment for hepatocellular carcinoma (HCC) is surgery, such as, by hepatic~     resection or liver transplantation, but less than 20% of HCC patients are suitable for~     surgery. In the remaining patients with inoperable and advanced HCC, trans-arterial~     chemo-embolization (TACE) has been widely used but TACE alone rarely produces complete~     response and commonly develops recurrence. Recently several small studies reported high tumor~     response and local control rate after stereotactic ablative radiotherapy (SABR) alone or with~     TACE for inoperable HCC. This study will evaluate SABR effect with 60 Gy in 3 fractionations~     for HCC with size of ≤ 5 cm and 3 cm apart from gastrointestinal tract.~   "
133046|NCT01825811|"~     The purpose of this study is to determine whether TissueGene-C, allogeneic human chondrocytes~     expressing Transforming Growth Factor(TGF)-b1, mixed with fibrin-glue is effective and safe~     in patients with degenerative arthritis.~   "
133047|NCT01825798|"~     The purpose of this study is to determine whether metformin is safe and effective in the~     treatment of weight or weight gain in young people with Autism Spectrum Disorders (ASD) who~     are currently taking atypical antipsychotic medication.~   "
133048|NCT01825785|"~     This multicenter, randomized, double-blind, placebo-controlled, ascending multiple dose study~     assesses the safety, tolerability, pharmacokinetics, and pharmacodynamics of subcutaneous~     administration of 6 doses of 1 mg/kg AMG 785 once every 2 weeks or 3 doses of 3 mg/kg AMG 785~     every 4 weeks in healthy men or postmenopausal women with low bone mass and 3 doses of 2~     mg/kg AMG 785 every 4 weeks or 6 doses of 2 mg/kg AMG 785 every 2 weeks in healthy~     postmenopausal women with low bone mass.~   "
133049|NCT01825772|"~     900 subjects having received dental implants 9-10 years ago are invited for a clinical and~     radiographic examination. The individuals were randomly selected from the National Health~     Insurance data register in Sweden.~      The clinical and radiographic examination of the 900 selected subjects will include~     assessments of implant loss, loss of prosthesis and technical / biological complications.~      Biological complications will be assessed from the findings in the clinical and radiographic~     examinations. Thus, signs of pathology in peri-implant tissues, probing pocket depth (PPD)~     and bleeding/pus on probing (BoP) will be recorded. Marginal bone loss and other findings in~     radiographs will also be evaluated.~      The prevalence, extent and severity of peri-implantitis will hereby be determined.~     Patient-centered outcomes will also be obtained.~   "
133050|NCT01825759|"~     The Impact of Compound danshen dropping pill for coronary heart disease (CHD) heart and~     artery structure and function in patients with hypertension~   "
133051|NCT01825746|"~     The purpose of this delayed cluster randomized intervention trial is to evaluate primary care~     strategies to increase goal setting, shared decision-making and evidence-based support and~     counseling for health behaviors and psychosocial issues through the implementation of a~     standard set of practical, patient-centered survey items and related decision support tools,~     called the My Own Health Report (MOHR) assessment. Nine pairs of diverse primary care~     practices will participate, four pairs of federally qualified health centers clinics and 5~     pairs of practice based research network practices. Practice pairs are similar in size,~     patient and staff mix, culture, and level of EHR integration. Within pairs, practices will be~     randomized to early or delayed intervention (4 months later). The intervention consists of~     implementing the MOHR assessment and patient counseling into clinical care for all patients~     presenting for wellness or chronic care during a 6 month study period. Prior to~     implementation, practices will receive brief training about health behavior counseling, goal~     setting, and action planning. Practices will also be provided materials to support~     evidence-based counseling and referrals to local community resources. MOHR assessment~     implementation details will be determined by each practice pair but will generally include~     (1) asking patients to complete the MOHR assessment on the web prior to encounters (available~     at www.MyOwnHealthReport.org it addresses10 distinct health behaviors and psychosocial issues~     including physical activity, diet, alcohol consumption, tobacco use, drug use, sleep, stress,~     depression and anxiety), (2) provision, via the tool, immediate patient feedback that~     includes identification of unhealthy issues, assessment of readiness to change,~     prioritization of issues to change, and preparation for goal-setting and action planning, (3)~     feedback to the primary care team on the patient status and priorities for change, (4)~     provision of counseling, goal setting, and referrals to local resources by clinicians during~     the subsequent office visit, and (5) follow-up with the clinicians and local resources as~     agreed upon by the patient and clinician. Data sources will include patient responses to the~     MOHR assessment, practice appointment records, and a patient experience survey mailed to the~     first 300 patients offered the MOHR assessment two weeks after their office visit. Primary~     outcomes will include the Reach and Effectiveness of the intervention. Reach will be assessed~     in early and delayed intervention sites when they field the MOHR assessment. Effectiveness~     will compare early and delayed intervention sites during the early intervention phase,~     allowing the delayed intervention sites to serve as controls. Reach outcomes will include the~     percent of eligible patients receiving and completing the MOHR assessment. Effectiveness~     outcomes will include the percent of patients reporting that they were asked about health~     topics, set a change goal, received assistance for making a change, were referred for local~     counseling and support, and/or made any changes. Additional outcomes will include maintenance~     of the MOHR assessment implementation beyond 4 months, changes in patient reported health~     behavior and psychosocial measures by repeated administration of the MOHR assessment 4 months~     after initial completion, qualitative assessments on implementation factors and context that~     influence outcomes, and cost, in terms of time and resources required for practices to~     implement the MOHR assessment.~   "
133052|NCT01825733|"~     Postoperative pain, the great concern for the patients undergoing spine surgery, has led to~     common use of opioid-based intravenous patient-controlled analgesia (IV-PCA) postoperatively.~     Opioid-based IV-PCA offers better pain control, which could facilitate early recovery,~     rehabilitation and increase patient satisfaction. However, its use inevitably increases the~     incidence of postoperative nausea and vomiting (PONV), another great discomfort, as high as~     80% in patients with multiple risk factors.Therefore, there have been consistent efforts to~     prevent PONV with multimodal therapies such as risk stratification, modification and~     preventive use of antiemetics.~      Of all antiemetics, 5-hydroxytryptamine (5-HT3) antagonist, especially ondansetron, is most~     commonly used and extensively studied to reduce PONV because of its efficacy and fewer side~     effects.[8] However, its efficacy is not quite satisfactory when it comes to PONV associated~     with opioid-based IV-PCA. Recently, there are many reports comparing the antiemetic efficacy~     between ondansetron and the 2 newly developed 5-HT3 antagonists, ramosetron and palonosetron.~     Ramosetron is known to have a higher affinity and longer duration of binding to 5-HT3~     receptor, therefore exhibits potent and sustained anti-emetic effect than previously~     developed 5-HT3 antagonists.Palonosetron has a unique allosteric binding to the 5-HT3~     receptor, which brings a higher affinity, longer duration of action and longer elimination~     half-time.According to the previous studies, both ramosetron and palonosetron showed superior~     antiemetic efficacy for PONV associated with opioid-based IV-PCA to ondansetron as expected~     by their theoretical advantages. However, it has never been evaluated which one has superior~     antiemetic efficacy for opioid-based IV-PCA associated PONV. Therefore, in this study, we~     tried to evaluate the relative antiemetic efficacy of ramosetron and palonosetron in~     controlling opioid-based IV-PCA related PONV.~   "
133053|NCT01825720|"~     Hyperlactatemia, occuring 10-20% in patients undergoing valvular heart surgery, is known to~     be associated with hemodynamic instability, organ dysfunction and increased postoperative~     morbidity and mortality. Glucose-Insulin-Potassium(GIK) has been constantly used as an~     adjuvant therapy in patients with myocardial infarction or in the patients undergoing~     valvular heart surgery to reduce the low cardiac output syndrome and mortality. GIK is known~     to prevent excretion of lactate and to increase the extraction of lactate after reperfusion~     with various mechanism. In addition, it is also known to decrease ischemic-reperfusion injury~     of myocardium after CPB, to improve myocardial contractility, insulin resistance and~     hyperglucemia. As a result, it brings hemodynamic stability and sufficient oxygen supply to~     the tissue, which might reduce the incidence of hyperlactatemia after valvular heart surgery.~   "
133054|NCT01825707|"~     The purpose of this study is to determine the absorption, metabolism, and excretion (AME)~     kinetics of YH4808 and to determine and characterize metabolites present in plasma, urine,~     and feces in man following a single dose of [14C] YH4808 200 mg (~100 µCi ±20 µCi)~     administered as a single oral dose.~   "
133055|NCT01825694|"~     This study plans to develop an integrated treatment for comorbid post-traumatic stress~     disorder (PTSD) and substance abuse (SA) in adolescents. The investigators aim to develop a~     treatment approach that is community-friendly, well-tolerated, and deliverable by substance~     abuse counselors (SAC) in outpatient settings. The proposed Trauma-Focused Substance Abuse~     Treatment (TFSAT) aims to reduce PTSD symptoms and substance use and build coping skills. The~     investigators propose to adapt an evidence-based trauma program, Cognitive-Behavioral~     Intervention for Trauma in Schools (CBITS), for adolescent substance abusers (ASAbusers); to~     assess the acceptability and feasibility of the integrated approach; and to pilot test the~     new program against standard care.~      The investigators hypothesize that the intervention group, compared to the control group,~     will reduce substance use and symptoms for traumatic stress.~   "
133056|NCT01825681|"~     Life Enhancing Activities for Family Caregivers is a six-week program designed to increase~     positive affect in people who care for a family member with dementia. The intervention~     consists of 6 weekly one-hour sessions conducted one-on-one with a trained facilitator to~     teach simple skills that are practiced at home in a study-supplied workbook. The program is~     preceded and followed by a 30-45 minute questionnaire. Follow-up assessments will be~     conducted at 1-month, 3-months, and 6-months post intervention.~      Primary hypothesis is that experimental subjects who participate in LEAF will demonstrate~     significantly greater improvements in psychological outcomes and will engage in more problem~     focused and positive appraisal forms of coping compared to the wait-list control condition.~   "
133057|NCT01825668|"~     The overall goal of this clinical study is to investigate how dietary cholesterol intake~     influences the plasma Total cholesterol (TC), LDL-Cholesterol levels and cholesterol~     metabolism between adults who had been breast-fed as infants as a function of the duration of~     breast feeding and quantity of early cholesterol intake. The study also aims to evaluate the~     effect of a plant sterol formulation in low fat milk shake in modulating the lipid profile~     favorably in the study population.~   "
133058|NCT01825655|"~     The purpose of this study is determine if long acting antihistamine like cetirizine can help~     with itching induced by opioid pain medications.~   "
133059|NCT01825642|"~     Surgical removal of the prostate (radical prostatectomy) is a common and generally effective~     treatment for prostate cancer. However, standard prostatectomy can affect urinary continence~     and sexual function. Different surgical techniques, such as nerve-sparing prostatectomy and~     seminal vesicle-sparing prostatectomy, may limit these treatment-related effects. In a~     standard prostatectomy, the seminal vesicles are removed completely. In contrast, during a~     seminal vesicle-sparing prostatectomy, the surgeon leaves a portion of the seminal vesicles~     intact. This is done because the nerves that are important to urinary continence and erectile~     function are located close to the seminal vesicles. The purpose of this study is to determine~     whether patients who undergo nerve-sparing prostatectomy with seminal vesicle-sparing~     experience better urinary and sexual functioning after surgery than patients who undergo~     standard nerve-sparing prostatectomy.~   "
133060|NCT01825629|"~     The purpose of this study is to determine the efficacy of a multidisciplinary therapy with~     physical, manual and deontology therapies in the treatment of temporomandibular joint~     dysfunction in patients with fibromyalgia syndrome.~   "
133061|NCT01825616|"~     Hypothesis: Six weeks of supplementation with vitamin D (4000 IU/day) using Dole's Vitamin D~     Portobello Mushroom Powder will increase winter serum vitamin D levels, and improve muscle~     function and strength, and innate immunity (granulocyte/monocyte phagocytosis and oxidative~     burst activity), and attenuate exercise-induced muscle damage and DOMS.~   "
133062|NCT01825603|"~     This phase I trial studies the side effects and best dose of ADH-1 when given together with~     gemcitabine hydrochloride and cisplatin in treating patients with pancreatic or biliary tract~     cancer that has spread from where it started to nearby tissue or lymph nodes (locally~     advanced) or spread to other parts of the body (metastatic) and cannot be removed by surgery.~     ADH-1 may stop the growth of cancer cells by blocking blood flow to the tumor. Drugs used in~     chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop~     the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. Giving ADH-1 together with gemcitabine hydrochloride and~     cisplatin may kill more tumor cells.~   "
133063|NCT01825590|"~     A difference between dialysate and serum sodium concentration leads to diffusive sodium~     transfer across the dialyzer membrane. The consequences of diffusive sodium flux into the~     patient can be chronic sodium overload leading to overhydration, hypertension, cardiovascular~     disease, and other problems. Diffusive sodium flux out of the patient can lead to~     intradialytic blood pressure instability. A simple strategy for alignment of dialysate and~     serum sodium concentrations was implemented starting in April/May 2010 in order to minimize~     the problems particularly associated with chronic sodium overload.~   "
133064|NCT01825577|"~     Falls in the elderly are a very common and serious health problem with devastating~     consequences. Those with dementia are 5 times more likely to experience falls than older~     people without significant cognitive impairment. Despite a growing awareness and the use of~     available treatments, the number of falls and fall related injuries continue to increase. It~     is important to develop more effective treatments to help reduce the number of falls and~     prevent injury. The assessments used in this study determine fall risk which predicts the~     likelihood of falls in the future.~      This study will evaluate the possible role of Methylphenidate, Ritalin, in preventing falls~     and improving symptoms of apathy, or indifference. Methylphenidate is FDA approved for the~     treatment of ADHD but is not currently approved by the FDA for preventing falls or improving~     apathy(lack of interest) in the elderly. The methylphenidate used in this study will be~     absorbed through the skin by wearing a small patch near the hip area.~      The specific primary aim of this open label study is to determine if use of transdermal~     Methylphenidate (t-MPH) causes a reduction in fall risk in patients with dementia.~      The hypotheses to be tested is that after receiving t-MPH for 4 weeks, subjects will show~     improvement in gait and mobility assessment scores when compared to gait and mobility scores~     at screening.~   "
133065|NCT01825564|"~     Replacing a G tube and placing feeding tubes is standard in the Emergency Department (ED) and~     ICU, respectively. However placement requires a chest or abdominal x-ray to confirm correct~     position. The investigators are testing the accuracy of the FDA approved devices RightSpot pH~     Indicator & RightLevel pH Detector in determining correct position based upon pH which will~     then be correlated with the standard of care x-ray.~   "
133066|NCT01825551|"~     The aim of this study is to evaluate the effect off Granulocyte Colony Stimulating Factor~     (GCSF) in the treatment of Amyotrophic Lateral Sclerosis (ALS) patients.~   "
133067|NCT01825538|"~     To understand current practices of pulmonary physicians in relation to Advanced Care Planning~     (ACP) in order to develop future disease-specific tools that will improve patient-physician~     communication about ACP.~   "
133068|NCT01825525|"~     The Olympus ScopeGuide® is a useful tool in speeding up colonoscopy and making it less~     painful for patients. It is currently contraindicated by the manufacturer for use with~     patients with implantable electronic devices (such as cardiac pacemakers). There is no~     evidence to back up this contraindication and with the number of pacemakers being inserted~     increasing by around 30 000 annually in the UK, more patients will be denied the use of this~     device should they require a colonoscopy.~      Participants with Pacemakers or Implantable Cardioverter Defibrillators will attend their~     check appointment. Following this they will be asked to lie with a colonoscope connected to~     the ScopeGuide® placed onto their abdomen (with clothes on) for 2 minutes. During this time~     they will be monitored for any irregular cardiac activity which may indicate electromagnetic~     interference. After this a second device check will occur and the participant will be sent~     home.~      The hypothesis is that the ScopeGuide will not interfere with the cardiac devices.~   "
133069|NCT01825512|"~     Haemoglobinopathies are a group of inherited disorders characterized by structural variations~     of the haemoglobin molecule. Most of the patients affected require for survival chronic red~     blood cells transfusions to overcome ineffective erythropoiesis. Unfortunately, all~     chronically transfused patients become clinically iron overloaded as there is no~     physiological mechanism for the removal of iron from the body. The pathologic changes and~     clinical manifestations associated to chronic iron overload are common among all~     transfusional iron-overload patients, albeit best documented in patients with~     beta-thalassemia major. The recommended treatment consists in regular blood transfusions~     combined with chelating therapy to remove the harmful iron accumulation in the body.~      Currently, in the clinical practice particularly in children and adolescents, the criteria~     leading to the choice of the chelating agent include also the adherence to therapy, thus~     favouring the use of oral chelators (Ceci A et al., 2011) DFP (Deferiprone) was the first~     oral chelator authorised in Europe in 1999 as second line treatment for the treatment of iron~     overload in patients with thalassaemia major when DFO (Deferoxamine) is contraindicated or~     inadequate. However, despite a wide experience of DFP with iron overloaded (specifically~     thalassaemic )patients, limited data are available for younger children. For this reason the~     need for additional data in younger children is expressively included in the 2009 PDCO~     (Paediatric Committee) Priority List.~      The purpose of this study is to assess the non-inferiority of DFP compared to DFX~     (deferasirox)in paediatric patients affected by hereditary haemoglobinopathies requiring~     chronic transfusions and chelation. Non inferiority will be established in terms of~     percentage of patients successfully chelated, as assessed by serum ferritin levels (in all~     patients) and cardiac MRI T2* (in patients above 10 years of age able to have an MRI scan~     without sedation).~   "
133070|NCT01825499|"~     Vermont Oxford Network maintains a database for live born infants 401 to 1500 grams or 22 to~     29 weeks gestational age who are born at participating hospitals or admitted to them within~     28 days of birth, regardless of where in the hospital the infant receives care.~   "
133071|NCT01825486|"~     Background: Accidental falls result in major physical and psychological morbidity in the~     elderly, especially stroke patients. To get optimal prevention of stroke falls, it is crucial~     to identify independent risk factors from multivariate analysis of related balance and gait~     parameters.~      Aim: To evaluate the effects of balance and gait characteristics in determining whether or~     not accidental falls may happen. To investigate if the balance and gait parameters affect the~     time from lesion to when (and if) patients suffer from falls. To compare differences of~     balance and gait parameters in accidental fall patients between those with severe accidental~     injuries and those without severe injuries.~      Methods: The 2-year observational cohort study will enroll 706 elderly stroke patients, who~     have not had a previous stroke. They will be retrieved from the Inpatient department and~     followed-up regularly in the Outpatient department when they are discharged. All subjects~     will be evaluated at 1 month and 6 months after stroke. These evaluations will include:~     mental, cognition and depression status; lower-limb muscle strength assessed by a dynamometer~     as well as range of motion of joints assessed by a biaxial electro-goniometry; functional~     independence measure; balance and gait pattern will be assessed by both clinical observation~     and objective laboratory examination (a dynamic posturography and computerized gait analysis~     system); falls and fall-related injuries during the proceeding year. Differences in baseline~     characteristics are tested by one-way ANOVA, Mann Whitney U or t tests, if appropriate. The~     investigators will identify the independent risk factors of accidental falls with logistic~     regression and use the log rank statistic of Kaplan-Meier survival curve to differentiate the~     risk of accidental falls or fall-related injuries in different groups.~   "
133072|NCT01825473|"~     To evaluate the relationship of reflux and apnea and to determine whether the administration~     of erythromycin improves the incidence of GER and GER-associated apnea, bradycardic and/or~     desaturation events in a prospective randomized controlled trial.~   "
133073|NCT01825460|"~     The purpose of this study is to determine the short-term effects of a manual therapy protocol~     on pain, disability and cervical range of motion in individuals with acute whiplash injury.~   "
133074|NCT01825447|"~     The main purpose of this study is to simulate if oxycodone and naltrexone combination~     capsules (ALO-02) were to be tampered with by dissolving and then injecting intravenously for~     the purpose of getting high.~   "
133075|NCT01825434|"~     Background and aims:Constipation is a frequent complaint and the combination of a prebiotic~     and probiotics would have a potentially synergic effect on the intestinal transit. The~     present study therefore aims to investigate the combination of polydextrose (Litesse®), L.~     acidophilus NCFM® and B. lactis HN019 in a yogurt on intestinal transit in subjects who~     suffer from constipation.~      Methods: Patients with constipation were randomly divided into two groups, Placebo Group (PG)~     and Treatment Group (TG), and had to eat 180 ml of unflavored yogurt every morning for 14~     days. Those in the CG received only yogurt, while the TG received yogurt containing~     polydextrose, L. acidophilus NCFM® (ATCC 700396) and B. lactis HN019 (AGAL NM97/09513).~     Expect that patients who took a combination of polydextrose has a decrease in the colonic~     transit time (CTT) when comparing initial and final transit time.~   "
133076|NCT01825421|"~     Unnecessary and prolonged antibiotic therapy in newborn babies can have serious consequences~     including development of necrotizing enterocolitis (a serious, potentially life-threatening~     gastrointestinal illness in premature babies), late-onset infections, resistance to~     antibiotics, increased length of hospital stay, and death.~      Starting and continuing antibiotic therapy for blood culture-negative infections in the~     neonatal intensive care unit (NICU) is fairly common with numbers of such patients varying~     from 20%-90% of infants undergoing a sepsis evaluation in the NICU.~      While blood culture results are the gold standard, there is usually a delay of up to 48-72h~     before the results are known. Hence, initiation and continuation of antibiotic treatment are~     usually based on clinical evaluation and blood count criteria which do not possess high~     specificity or sensitivity, and may be unreliable in the first few hours after birth or in~     the early stages of infection.~      Since the investigators found that neutrophil CD64 (a type of protein found on the surface of~     a type of white blood cell that can be detected quickly in a very small amount of blood~     sample) has high accuracy for early detection of blood culture-proven infections in newborn~     babies, with extremely high negative predictive value (can identify babies definitively with~     no infection), the investigators will use this test to decide whether to stop or continue~     antibiotics in the NICU.~      The investigators hypothesis is that neutrophil CD64 values can be safely used to discontinue~     antibiotics in newborns suspected of having infections.~      The investigators aims are to utilize sequential measurements of CD64 values to stop~     antibiotics early in neonates being investigated for both early and late-onset infections in~     the NICU.~      This is a prospective, randomized, controlled (RCT) trial. The study population will be~     derived from the sub-set of all newborn infants who have undergone investigations for~     presence of infection in the NICU.~   "
133077|NCT01825408|"~     The purpose of this study is to determine the best duration(3 versus 6 weeks) of antibiotics~     as part of maximal medical therapy for treating chronic sinusitis and thus preventing~     patients from having to have sinus surgery. The hypothesis is that in the context of maximal~     medical therapy 3 weeks of antibiotics is not worse than 6 weeks of antibiotics at~     successfully treating chronic sinusitis.~   "
133078|NCT01825395|"~     To learn more about the effect of 3, 4-Diaminopyridine (3,4-DAP) on patient diagnosed with~     Lambert-Eaton myasthenic syndrome (LEMS).~   "
133079|NCT01825382|"~     The goal of this prospective pilot study is to evaluate the use of remote technology (iBGStar~     in combination with Diabetes Manager App on iPhone) to patient related outcomes, and a~     hypoglycemia fear questionnaire. In the future, this study might lead to investigating the~     role of social media with mobile phones in Type 1 Diabetes (T1D) care. Moreover, the number~     of patients with T1D continues to increase, and such technology could conceivably help~     compensate for the shortages of endocrinologists providing care.~   "
133080|NCT01825369|"~     Infants with congenital heart disease and increased pulmonary blood flow have altered~     carnitine homeostasis that is associated with clinical outcomes; and L-carnitine treatment~     will attenuate these alterations and improve clinical outcomes.~      The investigators will pilot a trial assessing the safety and pharmacokinetics of~     perioperative IV L-carnitine administration in these patients. To this end, a pilot clinical~     trial is proposed. Infants with ventricular septal defects or atrioventricular septal defects~     undergoing complete surgical repair will receive L-carnitine (25, 50, or 100 mg/kg, IV) just~     prior to cardiopulmonary bypass (CPB) and 2hr after CPB. Carnitine levels will be measured~     before CPB, and before and 0.5, 1.5, 3, 5, 9, 12, and 24h after the second dose. The safety,~     pharmacokinetic profile, feasibility, and effect of L-carnitine administration on biochemical~     parameters, as well as clinical outcomes will be determined. The investigators expect this~     pilot to provide the data needed to proceed with a placebo-based randomized, controlled,~     trial.~   "
133081|NCT01825356|"~     The purpose of this study is to determine whether patients undergoing a dorsal cheilectomy~     procedure with implementation of amniotic membrane tissue results in improved clinical and~     functional outcomes compared to a standard dorsal cheilectomy procedure.~      Specific Aim 1:~      To compare American Orthopedic Foot and Ankle Society (AOFAS) scores between patients~     undergoing dorsal cheilectomy to patients undergoing dorsal cheilectomy with implantation of~     amniotic membrane tissue.~      Hypothesis 1: Clinical and functional outcomes, as measured by the AOFAS , in the patients~     undergoing dorsal cheilectomy with implantation of amniotic membrane tissue will be superior~     to those without.~      Specific Aim 2:~      To compare range of motion between patients undergoing dorsal cheilectomy to patients~     undergoing dorsal cheilectomy with implantation of amniotic membrane tissue.~      Hypothesis 2: Patient to undergo dorsal cheilectomy and implantation of amniotic membrane~     tissue will demonstrate less postoperative stiffness as measured from the pre-and~     postoperative radiographs.~      Specific Aim 3:~      To compare Foot Function Index (FFI) scores between patients undergoing dorsal cheilectomy to~     patients undergoing dorsal cheilectomy with implantation of amniotic membrane tissue.~      Hypothesis 3: Clinical and functional outcomes, as measured by the FFI, the patients~     undergoing dorsal cheilectomy with implantation of amniotic membrane tissue will be superior~     to those without.~   "
133082|NCT01825343|"~     Purpose: a retrospective study of all Paediatric patients who presented to Ziv Medical Centre~     with injuries of all systems, major and minor, in order to determine the exact circumstances~     of the injury, whether this might have been preventable and design a Haddon Matrix of risk~     factors for injury to target prevention.~      Hypothesis: injury prevention interventions can be targetted by finding out local causes of~     Paediatric Trauma~   "
133083|NCT01825330|"~     The study tests the effect of the NeuroAD on Alzheimer patients' cognitive function. The~     NeuroAD uses non-invasive stimulation of both magnetic and cognitive training.~   "
133084|NCT01825317|"~     Non-invasive stimulation of the brain using magnetic and cognitive stimulation by computer~     for the treatment of Alzheimer patients.~   "
133085|NCT01825304|"~     Intra-abdominal hypertension can increase the pleural pressure, and then end-expiratory~     transpulmonary pressures will be turn to negative, Pulmonary atelectasis/acute lung~     injury/acute respiratory distress syndrome will appear. In the group of people who suffering~     intra-abdominal hypertension, the investigators use the pressure of esophagus to speculate~     the Intrathoracic pressure, and to setting PEEP in order to decrease the happening of~     ALI/ARDS, which may decrease morbidity in this population.~   "
133086|NCT01825291|"~     The purpose of this study is to investigate the effectiveness of CPAP treatment to~     co-morbidities of sleep apnea by looking the change of the consumption of medication of the~     co-morbidities before and after starting the CPAP treatment.~   "
133087|NCT01825278|"~     This study proposes to evaluate the clinical applicability of the ExSpiron Respiratory Volume~     Monitor (RVM, ExSpiron™, Respiratory Motion, Inc.; Waltham, MA) in obese surgical patients~     undergoing general anesthesia. Previous work has demonstrated the ability of the ExSpiron~     monitor to provide non-invasive, real-time, continuous measurements of respiratory parameters~     such as tidal volume (TV), minute ventilation (MV) and respiratory rate (RR) mostly in normal~     weight patients but those studies did not specifically look at obese subjects. Respiratory~     depression, in the postoperative setting due to residual anesthetics and/or opioid~     administration, continues to be a significant cause of adverse outcomes. Obese patients are~     at increased risk for respiratory complications. Currently, there is no objective measure of~     early respiratory indicators for developing respiratory compromise. Current respiratory~     assessment in non-intubated patients relies on oximetry data and subjective clinical~     assessment. Pulse oximetry has been extremely helpful in recognizing oxygen desaturations but~     it is a late indicator of respiratory decline. There is no current device capable of giving~     real time ventilatory information such as tidal volume and minute ventilation of a patient~     that is not mechanically ventilated. The ExSpiron system utilizes an impedance based~     technology and proprietary algorithms (Respiratory Motion Inc.) to obtain these measurements.~     The study hypotheses are that the non-invasive, impedance-based RVM monitor will accurately~     reflect TV, RR and MV in obese surgical patients before induction of general anesthesia,~     during controlled ventilation and following extubation; that ExSpiron will accurately reflect~     the post-extubation respiratory status of the patient; and that apnea and hypopnea episodes~     in the recovery room as detected by the ExSpiron monitor are correlated with the individual~     risk for obstructive sleep apnea as determined by the STOP-Bang risk stratification.~   "
133088|NCT01825265|"~     Primary:~        -  To assess the safety and tolerability and to find the maximum tolerated dose of the~          combination administration of RAD001 plus docetaxel when given to patients with~          metastatic breast cancer who are being considered for standard docetaxel treatment~          (phase I).~        -  To characterize the pharmacokinetics of RAD001 and docetaxel when co-administered (phase~          I).~      Secondary:~        -  To assess the clinical efficacy of the combination regimens in this patient population~          as shown by response (according to the modified RECIST criteria) (phase II).~        -  To determine the phosphorylation status of the components of the mTOR signaling pathway~          and the expression of modifiers of apoptosis in the primary breast tumors, in order to~          determine whether these markers can be used as predictors of sensitivity to the~          combination of RAD001 and docetaxel~        -  To determine the effect of the combination of RAD001 and docetaxel on the expression and~          phosphorylation of mTOR's targets in the accessible tumor tissue, in order to identify~          potential pharmacodynamics markers of response to this drug combination~   "
133115|NCT01824914|"~     Difficult tracheal intubation is a cause of severe patient damage and death. There is not a~     good method to predict it. The McGrath Series 5 video laryngoscope can improve visualization~     of the glottic structures one to two grades. Moreover unlike a classical laryngoscope with a~     Macintosh blade, the McGrath provides a view of the glottis without requiring alignment of~     the oral, pharyngeal and laryngeal axes. In this study, the investigators will use it to~     compare the Cormack-Lehane score in sedation and anesthesia condition. It helps to know the~     role of videolaryngoscope in predicting difficult intubation.~   "
133089|NCT01825252|"~     During the formative research phase, investigators will undertake formative studies to~     locate, understand, and characterize high-risk social networks of African American MSM in the~     community; gain community participation, involvement, and input; and undertake interviews~     with key informants and community members to gain information needed to pilot test study~     recruitment procedures, measures, and intervention content.~      During a 4-year main outcome trial phase, the investigators will enroll 24 separate~     sociocentric (bounded) social networks composed predominantly of Black MSM. Each~     sociocentric network will consist of the ring of friends surrounding an initial high-risk~     index as well as all friends surrounding persons in this second ring and then friends~     surrounding a successive third snowball ring of enrollees. Each 3-ring sociocentric network~     is expected to consist of approximately 40 unique members (n=24 networks, each with 40~     members = approximately 960 individual participants).~      All participants will be assessed at baseline to measure sexual practices, substance use, and~     other risk characteristics over the past 3 months; asked to provide biological specimens to~     be tested for HIV and other sexually transmitted diseases (STDs); and counseled in HIV/STD~     risk reduction. STDs will be treated and those with HIV will be referred for treatment.~      The investigators will identify the individuals in intervention condition networks with the~     greatest number of reciprocal interconnections and the most favorable sociometric standing in~     the network. These individuals--expected to constitute approximately 20% of the sociocentric~     network and designated as network leaders--will be recruited to attend a 9-session program~     that provides training and guidance in how to deliver on-going, theoretically-based, and~     culturally tailored risk reduction advice and counseling to other members within the same~     network.~      Six and 18 months following the intervention, all participants will be reassessed on risk~     behavior and STD/HIV laboratory measures as well as measures of intervention exposure, with~     positive STD and HIV cases respectively treated or referred to care at each assessment point.~     Outcome analyses will test whether there is greater reduction in high-risk sexual practices,~     substance use associated with risky sex, and HIV/STD incidence within social networks in the~     intervention condition. The primary trial endpoints are reductions in prevalence and~     frequency of unprotected anal intercourse with nonexclusive partners, increased condom use,~     and lower incidence on a composite biological measure of new HIV/STD disease during the~     followup period.~   "
133090|NCT01825239|"~     Presently, the left ventricular lead is placed in a similar position for all patients. It is~     not known whether placing this lead in different positions in the heart will make the heart~     pump better. In this study, the investigator will collect measurements of the heart's~     electrical activity during an Electrophysiology Study (EP study or EPS). The hope is that~     these measurements will provide the know how to develop an individualized left ventricular~     lead placement prescription for patients referred for left ventricular lead pacing.~   "
133091|NCT01825226|"~     Helen Keller International (HKI) has been implementing homestead food production (HFP)~     programs in Asia for the past 20 years and has recently begun implementing HFP programs in~     Africa as well. In general, these programs target women and are designed to improve maternal~     and child health and nutrition outcomes through three primary pathways: 1. Increasing the~     availability of micronutrient-rich foods through increased household production of these~     foods; 2. Raising income through the sale of surplus production; and 3. Increasing knowledge~     and adoption of optimal nutrition practices, including the consumption of micronutrient-rich~     foods. Evaluations of HFP programs have consistently demonstrated significant increases in~     household production and consumption of micronutrient-rich foods. This increased consumption,~     along with improvements in health and nutrition related knowledge, and increased income,~     could all contribute to improvements in maternal and child health and nutrition outcomes.~     However, to date there has been limited understanding as to how these types of programs can~     be optimized to maximize impacts on these outcomes.~      In order to better understand the potential of these types of programs to improve maternal~     and child health and nutrition outcomes and how this impact may be achieved IFPRI has been~     collaborating with HKI to evaluate one of their E-HFP programs in Burkina Faso. The~     evaluation considers impact of the program through the three pathways above, and assesses~     anthropometric and clinical measures of nutrition, as well as looking at how the programs~     might be improved.~   "
133092|NCT01825213|"~     The purpose of this study is to evaluate the feasibility to stratify liver fibrosis in~     patients with chronic liver disease through non-invasive, spectral CT.~   "
133093|NCT01825200|"~     The hypothesis for this trial is that the incidence of a pre-defined composite of common~     systemic hypersensitivity adverse events for Flublok recipients is non-inferior to that~     reported for licensed IIV recipients. Another hypothesis is that the safety and~     reactogenicity of Flublok is clinically acceptable, i.e. consistent with the overall safety~     profiles previously observed with Flublok and with the licensed comparator.~   "
133094|NCT01825187|"~     The purpose of this research study is to measure the clinical effectiveness of two different~     polypropylene meshes used for laparoscopic inguinal hernias by evaluating subjects' length of~     hospital stay, perioperative complications, recurrence rate, pain score, comfort level and~     postoperative quality of life. A secondary goal of the study is to evaluate the ease of use~     and time it takes surgical residents to place the mesh and perform the surgery using these~     two different meshes.~   "
133095|NCT01825174|"~     The purpose was to investigate the consequences of pediatric overweight on the~     musculoskeletal system, postural control and proprioception, and to analyze prospectively the~     influence of ball games and nutrition counseling.~   "
133096|NCT01825161|"~     The main purpose of this study is to utilize a comprehensive, prospective clinical database~     to collect patient, diagnostic and treatment variables along with disease specific and~     generic health related quality of life (HRQOL) data on consecutively treated patients with~     metastatic spine tumors. The objectives are to determine the validity and reliability of the~     Spine Cancer Outcomes Questionnaire (SCOQ) for use in the assessment of spine tumor outcomes,~     to determine if the Spine Instability Neoplastic Score (SINS) Classification is a valid tool~     for predicting the stability of spine in metastatic spine disease, and to determine the~     efficacy of surgery versus radiotherapy for the treatment of impending instability secondary~     to metastatic disease of the spine.~   "
133097|NCT01825148|"~     The purpose of the study is to determine whether there are differences in pancreatic uptake~     of the radiotracer between healthy individuals and patients with type 1 diabetes. If T1D~     patients have a markedly reduced uptake, the compound may be suitable for estimation of~     pancreatic beta cell mass, i.e. the cells in the pancreas that produce insulin.~   "
133098|NCT01825135|"~     The primary aim of this proposal is to test the effectiveness of NMES in improving functional~     status and muscle function in patients requirng prolonged mechanical ventilation~   "
133099|NCT01825122|"~     To test the hypothesis that treatment with the inverse agonist nadolol will improve smoking~     cessation in patients with chronic cough associated with long-term smoking, with or without~     airflow obstruction, including those with established chronic obstructive pulmonary disease~     (COPD) (chronic bronchitis dominant) or non-obstructive chronic bronchitis (NCB), compared to~     placebo and standard of care, while undergoing a validated smoking cessation program.~   "
142095|NCT01707368|"~     The purpose of this observational study is to document the course of disease and relapse~     management during treatment with Daivobet® Gel under consideration of patient`s individual~     application habits under daily use conditions.~   "
133100|NCT01825109|"~     Rotavirus is the leading cause of severe gastroenteritis in infants and young children~     worldwide and is estimated to account for 600,000 deaths in children <5 years of age.~     However, live oral enteric vaccines (e.g. OPV, cholera vaccines, typhoid vaccine) have been~     less immunogenic in poor communities with high levels of malnutrition and poor sanitation.~     Rotavirus vaccines also appear to be less immunogenic in the setting where they are most~     needed. High maternal antibody (IgG) to rotavirus and breast feeding near the time of~     vaccination may inhibit rotavirus vaccine effectiveness. We propose a quick study to look at~     practical ways to improve the immunogenicity of rotavirus vaccine in our own setting in~     Bangladesh. The objectives are to assess if delaying Rotarix vaccination will improve the~     immune response to the vaccine and to assess if avoiding breastfeeding in the 45 minutes~     before and after vaccine administration will improve the immune response to administration of~     Rotarix vaccine. The study will be conducted in the urban Dhaka Mirpur Community, a setting~     where previous rotavirus vaccine immunogenicity studies have been successfully conducted. A~     total of 300 infant will be randomly assigned to one of the following groups: 1)~     Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus vaccine~     with no intervention in normal breastfeeding practices before and after receiving vaccine. 2)~     Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus.~     Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes~     after each vaccine administration. 3) Administration of Rotarix at 14 and 18 weeks~     co-administered with oral polio virus, with no intervention in normal breastfeeding practices~     before and after receiving vaccine. 4) Administration of Rotarix at 14 and 18 weeks~     co-administered with oral polio virus. Breastfeeding will not be permitted 45 minutes prior~     to vaccine administration and 45 minutes after each vaccine administration. Blood and stool~     samples will be collected from infants and breast milk from mothers. The primary outcome is~     to determine the sero-conversion rate of anti-rotavirus IgA in different groups of infants.~   "
133101|NCT01825096|"~     The principal advantages of functional magnetic resonance imaging (fMRI) with~     blood-oxygenation- level-dependent (BOLD) contrast for studying brain function are:~     non-invasiveness, ubiquitous availability, relatively high spatiotemporal resolution, and the~     ability to map function over the entire brain. Thus, BOLD fMRI is the most widely applied~     technology to study healthy brain function and pathophysiology associated with disease. In~     studies of drug abuse and psychiatric illness though, normal assumptions mapping BOLD signals~     to neurometabolism may be violated. Generally, these effects are ignored, resulting in large~     study-to-study variability.~      Quantitative fMRI (qfMRI) measures metabolism directly and is more suitable for studies of~     drug abuse and psychiatric illness. However, qfMRI is too complex for routine use. Cerebral~     metabolism during brain activation during visual stimulation measured with a new fMRI~     approach that is simple enough for clinical applications will be compared to CMRO2 activation~     measured using standard qfMRI.~   "
133102|NCT01825083|"~     Procedures performed under sedation have the same severity in regards to morbidity and~     mortality as procedures performed under general anesthesia1. The demand for anesthesia care~     outside the operating room has increased tremendously and it poses, according to a closed~     claim analysis, major risks to patients. Both closed claim analysis identified respiratory~     depression due to over sedation as the main risk to patients undergoing procedures under~     sedation. The major problem is that hypoventilation is only detected at very late stages in~     patients receiving supplemental oxygen. Besides the respiratory effects of hypoventilation,~     hypercapnia can also lead to hypertension, tachycardia, cardiac arrhythmias and seizures.~      The incidence of anesthetized patients with obstructive sleep apnea has increased~     substantially over the last years along with the current national obesity epidemic. These~     patients are at increased risk of hypoventilation when exposed to anesthetic drugs. The~     context of the massive increase in procedural sedation and the extremely high prevalence of~     obstructive sleep apnea poses major respiratory risks to patients and it may, in a near~     future, increase malpractice claims to anesthesiologists. The development of safer anesthesia~     regimen for sedation are, therefore, needed. The establishment of safer anesthetics regimen~     for sedation is in direct relationship with the anesthesia patient safety foundation~     priorities. It addresses peri-anesthetic safety problems for healthy patient's. It can also~     be broadly applicable and easily implemented into daily clinical care. Ketamine has an~     established effect on analgesia but the effects of ketamine on ventilation have not been~     clearly defined. The investigators have demonstrated that the transcutaneous carbon dioxide~     monitor is accurate in detecting hypoventilation in patients undergoing deep sedation. Animal~     data suggest that when added to propofol in a sedation regimen, ketamine decreased~     hypoventilation when compared to propofol alone. It is unknown if ketamine added to a~     commonly used sedative agent (propofol) and fentanyl can decrease the incidence and severity~     of hypoventilation in patients undergoing deep sedation.~      The investigators hypothesize that patients receiving ketamine, propofol and fentanyl will~     develop less intraoperative hypoventilation than patients receiving propofol and fentanyl.~      The investigators also hypothesize that this effect will be even greater in patients with~     obstructive sleep apnea than patients without obstructive sleep apnea.~      Significance: Respiratory depression due to over sedation was identified twice as the major~     factor responsible for claims related to anesthesia. The high prevalence of obstructive sleep~     apnea combined with more complex procedures done in outpatient settings can increase physical~     risks to patients and liability cases to anesthesiologists. The main goal of this project is~     to establish the effect of ketamine in preventing respiratory depression to patients~     undergoing procedures under deep sedation using propofol and fentanyl.~      If the investigators can confirm our hypothesis, our findings can be valuable not only to~     anesthesiologist but also to other specialties (emergency medicine, gastroenterologists,~     cardiologists, radiologists) that frequently performed procedural sedation.~      The research questions is; does the addition of ketamine prevent hypoventilation during deep~     sedation using propofol and fentanyl?~      The hypotheses of this study: Ketamine will prevent hypoventilation during deep sedation~     cases.~   "
133103|NCT01825070|"~     Cherries have been show to possess the ability to reduce uric acid concentrations and~     inflammation. Tart Montmorency cherries possess a higher concentration of the plant compounds~     than other cherries and hence makes the expectation possible that Montmorency cherries will~     lower uric acid and inflammation.~   "
133104|NCT01825057|"~     General medical hospitals provide care for a disproportionate share of patients who abuse or~     are dependent upon substances. This group is among the most costly to treat and has the~     poorest medical and substance use outcomes. Motivational interviewing(MI) is a~     well-recognized, evidenced-based substance abuse treatment that has been adapted for use as a~     brief intervention in health care settings.MI is applicable to many health-related behavioral~     problems, and can be taught to a broad range of health care clinicians. However, it is~     unclear which implementation strategies will lead to the efficient and proficient uptake of~     MI in general medical settings, such as medical inpatient units.~      Primary care clinicians have multiple practice demands and time constraints. New practices~     have the greatest chance of being implemented if they are simple and compatible with existing~     workflows and systems. Two widely used strategies to bring specialized practices into use~     within general hospital settings are the see one, do one apprenticeship model of training~     and use of consultation-liaison (CL) services. See one, do one has been a modus operandi in~     medical education for centuries and relies upon a competency-based supervision training~     approach. While it has been empirically validated in the specialty addiction field, less~     controlled testing of this implementation strategy is available in general medical settings.~     The apprenticeship approach requires that appropriate patients and trainers are available~     with high flexibility for teaching and supervision; when applied to behavioral counseling~     approaches, this may be seen as incompatible with the medical role and time constraints of~     clinicians. In contrast, ordering MI through CL is a relatively simple, minimally burdensome~     process and highly compatible with the way clinicians secure other specialist services for~     their patients in the hospital.~      We propose to conduct a randomized controlled trial using mixed quantitative and qualitative~     methods to examine the effectiveness of three different strategies for integrating MI into~     the practice of healthcare providers working within Yale New Haven Hospital's internal~     medicine hospitalist service and other general medical inpatient units. Specifically, we will~     randomize 40 healthcare providers to one of three conditions: (1) a continuing medical~     education workshop that provides background and shows healthcare providers how to conduct~     MI (the control condition, called SEE ONE); (2) a see one, do one apprenticeship model~     involving workshop training plus live supervision of bedside practice (DO ONE); and (3)~     ordering MI from CL after learning about it in a workshop (ORDER ONE). Following the~     respective MI trainings, each healthcare provider will be assessed for the provision of MI to~     40 study-eligible inpatients, recruited by the research team after admission to our general~     medical units.~   "
133116|NCT01824901|"~     This randomized phase I/II trial studies the side effects and best dose of fibroblast growth~     factor receptor (FGFR) inhibitor AZD4547 when given with docetaxel and to see how well it~     works in treating patients with recurrent non-small cell lung cancer. Drugs used in~     chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. FGFR inhibitor AZD4547 may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is~     not yet known whether docetaxel and FGFR inhibitor AZD4547 are more effective when given~     together or separately.~   "
133117|NCT01824888|"~     JUC is a commercially available wound care spray. It is evaluated for the efficacy when using~     as a hygienic hand rub following the protocol described in the European standard EN 1500:1997~     Chemical disinfectants and antiseptics - Hygienic handrub - Test method and requirement~     (phase 2/step 2). A crossover study to compare the JUC solution with 60% (v/v) propan-2-ol~     by using Escherichia coli K12 NCTC strain 10538 as test organism.~   "
133105|NCT01825044|"~     This is an open label study on the pharmacokinetics and safety of ciclosporin in patients~     with severe traumatic brain injury, who require intensive care unit admission and monitoring~     of intracranial pressure via a ventricular catheter. 20 patients will be screened, and~     subsequently enrolled after clinical stabilisation. Thereafter, patients will receive 2.5~     mg/kg bolus dose infusion of ciclosporin, followed by either 5 mg/kg/day or 10 mg/kg/day of~     ciclosporin as continuous infusion for 5 days+3 days monitoring at the intensive care unit.~     After an additional 30 days, a follow-up phone call will be made to the patient, or the~     patient's nursing staff, checking patient status and serious adverse events. The two dose~     levels will be investigated in 10 patients each, starting with the lower dose level for the~     first 10 patients. Patients will have samples of blood and cerebrospinal fluid drawn at~     pre-defined time points during the study for pharmacokinetic assessment and evaluation of~     biomarkers. Bedside monitoring with microdialysis and brain tissue oxygenation will be~     performed. The safety monitoring includes nephrotoxicity, hepatotoxicity, monitoring of~     intracranial pressure (ICP), infections monitoring and adverse events collection and~     reporting.~   "
133106|NCT01825031|"~     A randomised controlled trial to investigate three methods to reduce early mortality in~     adults, adolescents and children aged 5 years or older starting antiretroviral therapy (ART)~     with severe immuno-deficiency. The three methods are:~      (i) increasing the potency of ART with a 12 week induction period using 4 antiretroviral~     drugs from 3 classes~      (ii) augmented prophylaxis against opportunistic/bacterial infections and helminths for 12~     weeks~      (iii) macronutrient intervention using ready-to-use supplementary food for 12 weeks.~   "
133107|NCT01825018|"~     Formative Research Phase (Months 1-6) The investigators will undertake qualitative formative~     studies to: (1) identify barriers to highly active antiretroviral therapy (HAART) and~     strategies currently used to engage PLH in care; (2) identify access points and ways to reach~     a diversity of PLH social networks; (3) gain an understanding of PLH views, motivations,~     barriers, and facilitators of care entry, maintenance, and adherence; (4) examine the~     structure and segments of the PLH community in St. Petersburg; and (5) elicit input from~     members of the PLH community and its stakeholders concerning the planned network recruitment,~     assessment, and intervention procedures and content. The investigators will refine protocols~     used in their intervention pilot study based on findings of the formative research phase.~      Main Trial Phase (Months 7-60)~      Overview of the main intervention outcome trial's experimental design. The main trial is a~     two-arm randomized outcome study. A total of 32 sociocentric social networks of PLH will be~     recruited by first identifying initial seeds—always PLH who are either out-of-care or~     treatment nonadherent—in multiple access points that were identified in the formative phase.~     The investigators will then enroll three rings of HIV+ friends outward beginning with each~     seed. Each sociocentric network is expected to consist of approximately 16 to 18 individuals~     (expected n=32x18=576 participants). This estimate is based on the size and density of~     participants' personal networks observed in our pilot studies. Each network member will be~     assessed at baseline using measures to be described shortly and will receive individual~     motivational counseling in care and adherence. This session will prime participants to an~     understanding about the availability, accessibility, and benefits of care. Members of the 16~     PLH networks randomized to the experimental condition will then receive the network~     intervention. Cadres of empirically identified influence leaders within each network will be~     identified, trained, and engaged to reinforce network member engagement and adherence. At 6-~     and 12-month followup points, assessment data will again be collected to determine~     intervention impact on the primary and secondary outcomes.~   "
133108|NCT01825005|"~     The main aim is to validate and improve the predictive model for survival and toxicity in~     patients with cervical cancer through multicentric prospective data collection. The data~     contain information on patient, tumor and treatment characteristics. For this study,~     additional health related QOL scores will be assessed using the EORTC Quality of Life~     Questionair-CX24 and C30. The long term aim, beyond this specific study, is to build a~     Decision Support System based on the predictive model validated in this study.~   "
133109|NCT01824992|"~     to assess the efficacy and safety of recombinant human interferon α-2b gel (Yallaferon®) for~     the treatment of patients with cervical high-risk HPV infections; to analyze the HPV type~     infections and clinical negative conversion.~      285 patients with positive high risk HPV infection were randomized into interferon gel group~     and control group at ratio of 2:1 (203 patients in treatment group and 82 patients in control~     group). The patients in treatment group received 1g recombinant human α-2b interferon gel~     every other day for consecutive 3 courses of treatment, whereas no treatment was conducted in~     control group.~   "
133110|NCT01824979|"~     The purpose of the study is to observe the Pilairo mask in a lab setting.~   "
133111|NCT01824966|"~     There has been much controversy surrounding the biologic behavior and prognosis of esophageal~     signet ring cell (SRCs) containing carcinomas. To clarify the biologic behavior of SRCs, the~     investigators compared the clinicopathologic features and prognosis of SRCs with other~     adenocarcinomas (ADC) of the esophagus and gastroesophageal junction (GEJ).~   "
133112|NCT01824953|"~     Serum pepsinogen (PG) levels are considered reliable markers for progression of atrophic~     gastritis with a stepwise reduction in the serum PG I level or PG I/II ratio. A combination~     of serum PG levels and Helicobacter pylori serology are used as a biomarker strategy for~     detection of individuals at increased risk of gastric neoplasm based on Correa's hypothesis.~     The investigators aimed to uncover whether this combination method could predict the risk of~     gastric neoplasms and the progression of chronic atrophic gastritis after 3 years. All the~     participants will be followed for an expected average of 3 years.~   "
133113|NCT01824940|"~     Globally, stunting affects 26% (165 million) of under-5-year children, underlies 15-17% of~     their mortality and leads to long-term cognitive deficits, fewer years and poorer performance~     in school, lower adult economic productivity, and a higher risk that their own children will~     also be stunted, perpetuating the problem into future generations. Stunting begins~     antenatally and peaks at 18-24 months of postnatal life, when mean length-for-age Z-score~     (LAZ) is about -2.0 among children living in Africa and Asia. Improving the diets of young~     children can reduce stunting, though, at best, only by about one-third. Frequent diarrheal~     illness has also been implicated. However, the effect of diarrhea on permanent stunting is~     relatively small, maybe because children grow at catch-up rates between illness episodes.~      The Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial is motivated by a 2-part~     premise:~        -  A major cause of child stunting and anemia is Environmental Enteric Dysfunction (EED).~          EED is a subclinical disorder of the small intestine, which is virtually ubiquitous~          among asymptomatic people living in low-income settings throughout the world. EED is~          characterized by increased permeability which facilitates microbial translocation into~          the systemic circulation and triggers chronic immune activation.~        -  The primary cause of EED is infant ingestion of fecal microbes due to living in~          conditions of poor quality and quantity of water, sanitation, and hygiene (WASH).~   "
133118|NCT01824875|"~     This randomized phase II trial studies how well giving temozolomide with or without~     capecitabine works in treating patients with advanced pancreatic neuroendocrine tumors. Drugs~     used in chemotherapy, such as temozolomide and capecitabine, work in different ways to stop~     the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by~     stopping them from spreading. It is not yet known whether temozolomide is more effective with~     or without capecitabine in treating patients with advanced pancreatic neuroendocrine tumors.~   "
133119|NCT01824862|"~     Clinically significant macular edema (CSME) is a thickening of the macula associated with the~     risk of visual loss, which increases its centre is involved. Functional evaluation of the~     macula relies on best corrected visual acuity; however, neural dysfunction in diabetic eyes~     appears before retinal thickening and visual loss. Retinal sensitivity decreases in eyes with~     CSME, but it is unknown whether it differs between eyes with and without centre thickening.~      Aim: To compare the reduction of foveal sensitivity in eyes with CSME, with and without~     centre thickening.~   "
133120|NCT01824849|"~     Total arytenoidectomy is claimed to increase risk of aspiration and cause more voice loss~     than other operations performed for bilateral vocal fold paralysis (BVFP). However, objective~     evidence for such conclusion is lacking. There is no study comparing swallowing and voice~     after total and partial arytenoidectomy.~   "
133121|NCT01824836|"~     E1Z11 is a study to determine whether certain genetic information can predict which breast~     cancer patients will discontinue treatment with AIs due to the development of musculoskeletal~     symptoms (MSS). Women with stage 1-111 breast cancer who are prescribed the aromatase~     inhibitor anastrozole as treatment may join.~   "
133122|NCT01824823|"~     This randomized phase II trial studies how well giving afatinib after chemoradiation and~     surgery works in treating patients with stage III-IV squamous cell carcinoma of the head and~     neck at high-risk of recurrence. Afatinib may stop the growth of tumor cells by blocking some~     of the enzymes needed for cell growth.~   "
133123|NCT01824810|"~     This pilot study is being conducted to provide proof of concept for three recently developed~     needling treatments, in the treatment of whiplash associated disorder type 2 (WAD-II). The~     investigators aim to show that these techniques should be considered as regular, effective~     options for people suffering from WAD-II. These techniques are Intramuscular stimulation~     (IMS), neural prolotherapy (NPT), and myoActivation (mA).~      Additionally, the investigators plan to begin profiling responders and non-responders in an~     effort to identify which treatment is likely to work best for different people. In the~     future, this may help to expedite treatment for WAD-II, helping patients get the most~     appropriate treatment, more quickly.~      The investigators expect to show that all three treatments are significantly better than a~     placebo treatment, and to collect information on what makes each technique more or less~     likely to work for individual cases.~   "
133124|NCT01824797|"~     The purpose and objective of this study is to determine the changes in bone metabolism after~     bariatric surgery in postmenopausal women.~      This is a prospective cohort study that will enroll up to 40 postmenopausal female subjects~     with class II and III obesity from the Duke Center for Metabolic and Weight Loss Surgery. The~     study team will enroll subjects that are already being scheduled for either sleeve~     gastrectomy or Roux-en-Y gastric bypass. The osteoclast activity, the osteoblast activity,~     and the bone mineral density will be measured in all subjects preoperatively and 12 months~     postoperatively through research specific blood tests and Dual energy x-ray Absorptiometry~     (DEXA) scans.~      The primary endpoints are change in osteoclast activity as measured by C-terminal telopeptide~     of type I collagen and change in bone density as measured by DEXA scan. These are continuous~     variable and given the small sample size the investigators will use a nonparametric Wilcoxon~     rank-sum test to compare the difference in one year change in these variables. There is a~     slight risk of loss of confidentiality. Every effort will be made to protect all PHI. There~     is also the risk of increased exposure to radiation from the DEXA scans performed twice with~     each subjects participating in the study.~   "
133125|NCT01824784|"~     To determine optimal cut-off value for TopQ cut-off.~   "
133126|NCT01824771|"~     Continuous Veno-Venous Hemofiltration (CVVH) can eliminate metabolic products effectively and~     replace renal function partly. It is widely used in intensive care units (ICUs), especially~     for patients with acute kidney injury/failure in an unstable hemodynamic status. Lactate is a~     molecule smaller than glucose, which can pass through filtration membrane freely in CVVH.~     Therefore, the blood lactate concentrations would no longer reflect tissue oxygenation status~     in patients with unstable hemodynamic status. However, there is no prospective study~     evaluated the effect of CVVH on lactate removal in critically ill patients. The influence of~     different dose of CVVH on lactate elimination is not clear in patients with different level~     of serum lactate. Our study aimed to find out how the dose of CVVH effects on lactate~     clearance, and then re-estimate the prognostic value of lactate in critically ill patients~     with CVVH.~   "
133127|NCT01824758|"~     90 American society of anesthesiology (ASA) physical status I and II patients undergoing~     general anesthesia for elective surgery will be included in the study. Patients will be~     randomized into three groups. Group E will receive esmolol (1 mg/kg), Group IL lidocaine (1.5~     mg/kg)and Group C placebo(NaCl 0.9%, 5 mL), followed by a 0.05 mg/kg rocuronium. After~     intravenous induction with propofol, adequate muscle relaxation for intubation will be~     received by 0.5 mg/kg rocuronium.~   "
133128|NCT01824745|"~     This randomized pilot clinical trial studies survivorship care planning in improving the~     quality of life in breast cancer survivors. Survivorship care planning may reduce stress and~     improve the well-being and quality of life of cancer survivors.~   "
133129|NCT01824732|"~     This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy~     of Chinese Medical Sciences in December 2012.~      The purpose of this study is to make a event monitoring to see whether Tanreqing injection is~     safe and the characteristic and mechanism of anaphylactic reaction used Tanreqing injection~     in hospitals in China.~   "
133130|NCT01824719|"~     This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy~     of Chinese Medical Sciences in January 2013.~      The purpose of this study is to make a event monitoring to see whether Reduning injection is~     safe and the characteristic and mechanism of anaphylactic reaction used Reduning injection in~     hospitals in China.~   "
133131|NCT01824706|"~     A Prospective, Multicenter Observational Study Evaluating the Long Term Safety in Terms of~     Explantation Rate and Number of Infections of the Custom-made Bioceramic Implant CustomBone™~      The patients will be included as soon as they are ilplanted and follow-up for 2 years. It is~     observationnal so no specific exam is planned.~      The explantation rate will be measured, that is to say the number of patients whose~     prosthesis will be removed (with or without any relationship with the implant or the~     procedure).~   "
133132|NCT01824693|"~     This randomized phase II trial studies how well giving busulfan, cyclophosphamide, and~     melphalan or busulfan and fludarabine phosphate before donor hematopoietic cell transplant~     works in treating younger patients with juvenile myelomonocytic leukemia. Giving chemotherapy~     before a donor hematopoietic transplant helps stop the growth of cancer cells. It may also~     stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem~     cells from a donor are infused into the patient, they may help the patient's bone marrow make~     stem cells, red blood cells, white blood cells, and platelets. It is not yet known whether~     giving busulfan, cyclophosphamide, and melphalan or busulfan and fludarabine phosphate before~     a donor stem cell transplant is more effective in treating juvenile myelomonocytic leukemia.~   "
133133|NCT01824680|"~     The primary purpose of this protocol is to assess the hormonal regulation of satiety by an~     intense exercise before and after a 3 month physical activity program. Hormones assessed are:~     leptin, grhélin, Cholecystokinin, Glucagon-Like-Peptid-1 (GLP-1), PYY.~      It is well known that in overweight adults and children also, an intense physical exercise~     diminish the food intake relatively to the total energy expenditure and this effect is~     persistent after a 6 weeks physical activity program.~      Our hypothesis are: a diminution of food intake after the intense physical exercise and a~     persistent diminution of food intake after the 3 month physical activity program, an~     augmentation of levels of GLP-1 and PYY during the intense exercise before and after the~     physical activity program, a diminution of the level of GLP-1 and leptin before and after the~     physical activity program~   "
133134|NCT01824667|"~     The aim of the study is to evaluate the effects of a new food supplement which is currently~     available in the market, called Bimuno® (B-GOS), on gastrointestinal discomfort (e.g.~     bloating, abdominal pain/cramp and flatulence) in adults who often experience these symptoms~     but are otherwise healthy.~      About 400 volunteers will take part in this study, which will last 6 weeks (to include 4~     weeks treatment and 2 weeks follow up period).~      Episodes of abdominal pain or discomfort (e.g. bloating, abdominal pain/cramp and~     flatulence), in the absence of diseases, are commonly associated with food or drug intake or~     with alterations of bowel habit and vary between individuals in frequency and severity.~      Some dietary ingredients are known to reduce these symptoms. We have used B-GOS previously in~     trials with healthy younger and older adults and we have observed a trend towards reducing~     abdominal bloating. However, the investigators have not tested B-GOS in healthy adults who~     often experience these symptoms and this is what we will investigate now.~   "
133135|NCT01824654|"~     An increasing incidence of abdominal aortic aneurysms (AAA) is observed in our ageing~     population. Since it is less invasive, endovascular repair (EVAR) by stent-graft (SG)~     insertion is frequently indicated in patients with intermediate and high-operative risk.~     Patient selection and stent planning for EVAR is done on CT-scans based on specific anatomic~     criteria. SG are inserted in the catheterization laboratory under digital substraction~     angiography (DSA) and fluoroscopic guidance. With this technology, no soft-tissue~     differentiation is available during the intervention and important information are lacking~     such as thrombus and aneurysm extension close to proximal and distal landing zones. Our team~     has recently patented a software allowing the extraction of the AAA (lumen and thrombus) from~     pre-operative CT-scanner. In collaboration with Siemens medical, the investigators have~     integrated this technology to the Siemens workstation in the catheterization laboratory. The~     investigators can now import the aortic lumen and thrombus meshes segmented from~     pre-operative CT-scans and perform a rigid registration with fluoroscopy and DSA data to~     enhance visualization of soft tissue during EVAR.~      Our preliminary results are encouraging in terms of feasibility and visualization. However,~     the delivery device of the SG and the guidewire used during the intervention are stiff and~     induce a deformation of aortic lumen and thrombus. This deformation impairs the accuracy of~     rigid registration. The investigators propose to improve registration accuracy by~     implementing an elastic deformation of aortic lumen and wall based on the segmentation of~     endovascular devices (delivery device, guidewires and catheters) inserted during the~     procedure and by biomechanical modeling.~   "
133136|NCT01824641|"~     The Physiologic Assessment of Thrombus Aspiration in ST-segment Elevation Myocardial~     Infarction (PATA-STEMI) trial is a single center, prospective, randomized trial with a~     planned inclusion of 128 patients with the first ST-segment elevation myocardial infarction~     (STEMI). Patients are, before coronary angiography, randomly assigned to thrombus aspiration~     using 6 or 7 French Eliminate aspiration catheter (Terumo Medical Supply, Japan) or to~     conventional primary percutaneous coronary intervention (PCI). The primary endpoint is index~     of microcirculatory resistance (IMR), measured in infarct-related artery, in thrombus~     aspiration compared to conventional PCI group.~   "
133137|NCT01824628|"~     This is a unicentric, two cohorts, observational transversal study.~      The purpose of this study is to compare the QT/QTc intervals of HIV positive subjects~     receiving an antiretroviral therapy and those without HIV in an ambulatory care setting.~   "
133148|NCT01824485|"~     Viscosupplementation by intra-articular injection of hyaluronate products has recently gained~     popularity as a treatment modality of gonarthritis.There is not, however, a consensus on the~     best method.Our objective is to evaluate what is the best dosage of viscosupplementation with~     hyaluronic acid (OSTEONIL®) associated with 1 ml (20 mg) of triamcinolone hexacetonide. One~     hundred and four patients with knee osteoarthritis (KOA) were divides into 2 groups of 52~     patients each to receive either a single application of 3 ampoules of OSTEONIL® + 1ml of~     Hexacetonide of triamcinolone or three applications of 1 ampoule of OSTEONIL®, one per week~     for three weeks + 1ml of Hexacetonide of triamcinolone only in the first injection. Primary~     endpoint was clinical results expressed by Visual Analogic Scale of pain (VAS), Western~     Ontario and Mcmaster Universities (WOMAC) and Lequesne questionaires at one, three, six and~     12 months after the procedure~   "
142359|NCT01703923|"~     The purpose of this study is to determine the antitussive effect size and dose response of~     FP01 lozenges in subjects with chronic cough and to demonstrate the safety and tolerability~     of FP01 lozenges in subjects with chronic cough.~   "
133138|NCT01824615|"~     Patients with early and advanced stages of epithelial ovarian cancer are treated with~     postoperative systemic chemotherapy after appropriate surgical staging and cytoreductive~     surgery. For ovarian cancer patients with recurrence, salvage chemotherapy with or without~     secondary cytoreductive surgery are recommended. The recommendation for specific primary~     adjuvant or salvage chemotherapy is cyclophosphamide or paclitaxel plus platinum regimens.~     Despite the high objective response rate associated with primary chemotherapy in ovarian~     cancer, the majority of patients will eventually experience disease recurrence and be~     potential candidates for a second-line treatment approach.~      Ovarian clear cell adenocarcinoma (OCCA) is recognized as a distinct histological type of~     cancer in the WHO-classification of ovarian tumors. OCCA is thought to arise from~     endometriosis and most patients present with the disease at early stages (International~     Federation of Gynecology and Obstetrics (FIGO) stages I and II). The incidence of OCCA among~     epithelial ovarian cancers is estimated to be less than 5-10%. However, OCCA occurs more~     frequent in Japan and Taiwan (around 10-15%). Unfortunately, OCCA is usually more resistant~     to systemic chemotherapy than other types and has a poorer prognosis.~      Sunitinib is a small molecule with anti-tumor properties pharmacologically mediated through~     inhibition of multiple receptor tyrosine kinase (RTKs), which are important regulators of~     tumor cell growth, angiogenesis, and metastasis. Due to its multi-targeted profile, the~     pharmacological activity of sunitinib is likely mediated by inhibition of multiple RTK~     targets and multiple pathways. c-KIT has been implicated in mastocytosis/mast cell leukemia,~     germ cell cancers, small-cell lung cancer, GISTs, AML, neuroblastoma, melanoma, and ovarian~     and breast carcinoma. In addition, sunitinib has demonstrated a higher response rate than~     that reported for anti- VEGF antibody treatment in patients with renal cell carcinoma (RCC).~     A few clinical case reports indicated sunitinib is effective in treating recurrent ovarian~     clear cell adenocarcinoma (OCCA) which is almost resistant to second line chemotherapy.~      So we would like to conduct this Phase II Sunitinib clinical trial in recurrent / persistent~     ovarian clear cell cancer patients.~   "
133139|NCT01824602|"~     The primary study objective was to evaluate the dose-dependent efficacy of eslicarbazepine~     acetate administered at doses of 600, 1200, and 1800 mg over a 3-week period, compared with~     placebo, as therapy in patients with acute mania. The secondary objectives of this study were~     to a) evaluate the safety and tolerability of eslicarbazepine acetate (BIA 2-093)~     administered at doses of 600, 1200, and 1800 mg compared with placebo, b) assess the duration~     to onset of action in the different dose groups, and c) monitor the appearance of depressive~     symptoms.~   "
133140|NCT01824589|"~     The purpose of this study is to demonstrate proof of clinical concept that application of the~     Intrathoracic Pressure Regulator (ITPR) will result in an increase in Cerebral Perfusion~     Pressure (CPP) and a decrease in Intracranial Perfusion Pressure (ICP) in patients with head~     injury and elevated ICP, and to determine the optimal ventilation tidal volume (TV).~   "
133141|NCT01824576|"~     The purpose of the study is to evaluate the physiological response to application of the~     Intrathoracic Pressure Regulator (ITPR) in patients with compromised cerebral circulation.~     The study will evaluate the physiological response to intrathoracic pressure regulation (IPR)~     therapy in hemodynamically stable patients with compromised cerebral circulation who are on~     ventilatory support.~   "
133142|NCT01824563|"~     The goal of this investigation is to generate the needed PMCF data for the HiFocus Mid-Scala~     electrode. As a point of interest the investigators would like to evaluate the benefit to~     patients with low-frequency residual hearing implanted with the HiFocus Mid-Scala Electrode.~     The HiFocus Mid-Scala electrode array is designed to allow surgeons the flexibility to use a~     variety of contemporary surgical techniques that have been shown to enable easy insertion and~     to minimize cochlear trauma (see, e.g., Adunka and Buchman, 2007; Friedland and~     Runge-Samuelson, 2009; Roland et al., 2007). Temporal bone experiments have shown the HiFocus~     Mid-Scala electrode array to be straightforward to insert while causing minimal trauma to~     cochlear structures during and after surgery (Lenarz et al., 2010). In addition , the HiFocus~     Mid-Scala has already shown to be a safe electrode and promising post op clinical results in~     the premarketing study that is now in the final stage.~   "
133143|NCT01824550|"~     The objective of this study is to determine the effect of home-based, aerobic exercise~     training on subclinical atherosclerosis and mobility disability in persons with Multiple~     Sclerosis (MS). Our central hypothesis is that aerobic exercise training reduces both~     subclinical atherosclerosis and mobility disability.~   "
133144|NCT01824537|"~     Human papillomavirus (HPV) is a member of the Papillomaviridae family of DNA viruses that is~     capable of infecting humans. HPV infection can cause cancers of the cervix, vulva, vagina,~     and anus in women or cancers of the anus and penis in men. Two prophylactic vaccines have~     been proven to be highly effective in preventing the acquisition of HPV infection and the~     genital precancerous lesions caused by it. However, we do not know yet if a previously~     infected individual, once vaccinated, would be less infective to her or his sexual partner.~     We plan to conduct a study, called Transmission Reduction And Prevention with HPV vaccination~     (TRAP-HPV) study to answer this question. It will include 500 sexually active couples (total~     of 1000 individuals) in university student health clinics in Montreal (age 18-45 years). It~     will be a randomized placebo-controlled, double-blinded intervention trial. Study~     participants will be followed up to 12 months. Behavioural and biological data will be~     collected at the time of study enrolment, then at months 2, 4, 6, 9 and 12 post-enrolment.~     The results of this trial will be invaluable in informing policies regarding vaccination of~     women and men.~   "
133145|NCT01824524|"~     The purpose of this study is to assess the single dose pharmacokinetic profile (explores what~     a drug does to the body) and safety of Osmotic Release Oral System (OROS) hydromorphone in~     chinese participants with cancer (abnormal tissue that grows and spreads in the body) who are~     not opioid (morphine-like medications) tolerant (decrease in response to a fixed dosage of~     drug over time and higher doses of a drug are needed to get desired effect).~   "
133146|NCT01824511|"~     The most widely-accepted animal model of nicotine withdrawal states stopping nicotine makes~     rewarding events become less rewarding. The current study will test if this is true in~     humans. If we find tobacco abstinence does make rewards less rewarding, this would suggest~     new symptoms to add to official descriptions of nicotine withdrawal. It would also suggest we~     need to develop new behavioral and pharmacological interventions to correct this problem. If~     stopping smoking does not make rewards less rewarding, this would suggest this animal model~     does not apply to the human condition and we need to continue to search for an animal model~     of tobacco withdrawal that is relevant to smokers stopping smoking.~   "
133147|NCT01824498|"~     The primary objective of this investigation is to determine whether diets designed to~     increase plasma n3 concentrations (a low fat diet, with or without n3 fatty acid enrichment),~     will favorably affect sex hormone distribution in women in a direction associated with~     reduced risk of sex hormone-mediated cancer development. Specifically, we hypothesize that an~     increased concentration of circulating n3 fatty acids will reduce the biochemical markers~     associated with increased risk for developing certain sex hormone mediated cancers such as~     breast cancer~   "
133149|NCT01824472|"~     Nearly half of all patients with obstructive sleep apnea have insomnia symptoms, and in some,~     but not all cases, these insomnia symptoms are caused by the obstructive sleep apnea. The~     purpose of this study is to find out what type of insomnia symptoms are caused by obstructive~     sleep apnea and therefore most likely to respond to obstructive sleep apnea treatment with~     continuous positive airway pressure (also known as CPAP) and if additional treatment with~     cognitive-behavioral therapy for insomnia is beneficial.~   "
133150|NCT01824459|"~     The purpose of this study is to evaluate the effectiveness and safety of S-1+Oxaliplatin~     vs.S-1+Cisplatin First-line Treatment in Advanced or Recurrent Non-intestinal Gastric~     Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma Patients.~   "
133151|NCT01824446|"~     To evaluate how the body absorbs, metabolizes (breaks down) and excretes (eliminates) the~     study drug. Further, the study will determine how much of the study drug gets into the~     bloodstream and how long it takes the body to get rid of it when given as a single dose to~     healthy male subjects.~   "
133152|NCT01824433|"~     Women are more prone to depression at certain points of the life cycle, although the~     etiologic and therapeutic implications remain largely unknown1,2. It is reported that pre-~     and postmenopausal women have a significant difference in response to some antidepressants,~     within a large clinical trial data set3, 4. A growing number of researches indicate that a~     woman's hormonal status may influence response to different forms of antidepressant~     medication. Specifically, younger women appeared to respond better to monoamine oxidase~     inhibitors (MAOIs) and selective serotonin reuptake inhibitor (SSRIs), whereas men and older~     women have tended to have relatively better responses to tricyclic antidepressants (TCAs)~     1-5. One difference between these classes of antidepressants is that the SSRIs are strongly~     serotoninergic, whereas TCAs have predominantly noradrenergic effects. One pooled analysis 6~     suggests that older women (age ≥ 50) tend to respond poorer to SSRI, while this phenomenen~     was not observed with venlafaxine.~      The antidepressive mechanism of venlafaxine that has both noradrenergic and serotonergic~     effects is superior to SSRIs. As a noradrenergic and serotonergic antidepressant,~     venlafaxinee has been demonstrated of significant advantages in response and remission rates~     compared with various SSRIs. As mentioned above, older women tend to have relatively better~     responses to TCAs which is predominantly noradrenergic antidepressant. Postmenopausal women~     with depression also would be predicted to respond better to an SSRI if administered along~     with hormone replacement therapy 6. This could be critical to understanding age difference in~     antidepressant responses across the life cycle because circulating estrogen levels may~     modulate central serotoninergic pathways. Therefore, it is presumed that antidepressants~     which enhance both serotonergic and noradrenergic neurotransmission, as venlafaxine, may be~     more effective than SSRIs for postmenopausal women with major depressive disorder.~   "
133153|NCT01824420|"~     To investigate if oxybutynin ER adding on antimuscarinics is more effective than~     mono-antimuscarinic treatment for patients with refractory OAB~   "
133154|NCT01824407|"~     The Sponsor of this study, SANUWAVE, Inc., has developed an investigational device known as~     the dermaPACE® (Pulsed Acoustic Cellular Expression) device for the possible treatment of~     diabetic foot ulcers. This device generates acoustic (sound) pressure waves designed to act~     on the cells in your body to generate proteins that may lead to wound closure. The dermaPACE®~     device has not been approved for the treatment of diabetic foot ulcers; therefore its use in~     this study is investigational.~      The purpose of the study is to evaluate the ability of the dermaPACE® device to help diabetic~     foot ulcers heal more quickly. The active study device, the dermaPACE®, will be compared to~     an inactive look-alike device (called a Sham) in this study. The sham device will not~     provide any treatment to your diabetic foot ulcer.~   "
133155|NCT01824394|"~     To demonstrate safety and effectiveness of nMARQ Catheter System [nMARQ] compared with~     THERMOCOOL® Navigational Family of catheters in treating subjects with drug-refractory~     symptomatic paroxysmal atrial fibrillation (PAF).~   "
133156|NCT01824381|"~     The purpose of this study is to analyze the security application of the amniotic membrane in~     extensive wounds in the granulation phase.~   "
133157|NCT01824368|"~     The purpose of this study is to evaluate the safety of extracorporeal photopheresis in~     patients with long-standing liver transplantation subjected to a progressive reduction of~     immunosuppression by complications arising from its use.~   "
133158|NCT01824355|"~     The purpose of this study was to demonstrate that untrained subjects who have diabetes can~     operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose~     results.~   "
133159|NCT01824342|"~     This is a multi-national, multi-center, open-label, single-arm extension study for the~     prolongation of bone metastasis-free survival in men with hormone-refractory (androgen~     independent) prostate cancer. Patients currently participating in the phase 3 study 20050147~     (NCT00286091) will be offered this study if a positive benefit:risk compared with placebo is~     determined in the 20050147 study. The primary endpoint of the 20050147 study is bone~     metastases-free survival determined by the time to first occurrence of bone metastases~     (either symptomatic or asymptomatic) or death from any cause. Participants will receive~     open-label denosumab administered once every 4 weeks (Q4W) subcutaneously (SC) until they~     developed a bone metastasis or for up to 3 years, whichever comes first.~   "
133160|NCT01824329|"~     Bladder cancer is the 4th most common cancer amongst men. If bladder cancer invades the~     muscle of the bladder or fails local treatments, surgical removal of the bladder (cystectomy)~     with creation of a new bladder from intestine is required. However, standard cystectomy~     affects urinary function and sexual function. The investigators are evaluating two~     modifications to cystectomy to determine to what extent they preserve urinary and sexual~     function.~   "
133161|NCT01824316|"~     Investigate differences in practice patterns in providers who may care for pregnant women~     with asthma exacerbations. The investigators believe that practitioners of different~     specialties will practice differently.~   "
133162|NCT01824303|"~     The purposes of the study is to determine if LiRIS®, an investigational drug-delivery system,~     is safe and tolerable in women with Interstitial Cystitis (IC), and to evaluate any change in~     IC symptoms following LiRIS administration.~   "
133163|NCT01824290|"~     The main purpose of this study is to evaluate the safety and efficacy of tadalafil in~     pediatric participants with pulmonary arterial hypertension. Participants will receive study~     treatment for 6 months in the double-blind period (Period 1), and then will be eligible to~     enroll into an open-label 2 year extension period (Period 2) during which participants will~     receive tadalafil.~   "
133177|NCT01824108|"~     Lumbar disc herniation is usually treated by discectomy alone. Nonfusion system such as~     Wallis interspinous implants have also been successfully used in disc degenerative diseases.~     However, the superiority of a discectomy with Wallis in comparison to a discectomy alone for~     primary lumbar disc herniation has yet to be determined.The aim of our study is to~     investigate whether lumbar discectomy combined with the Wallis device provides better~     radiographic and clinical short-term outcome than posterior lumbar discectomy alone.~   "
133164|NCT01824277|"~     The Canadian Diabetes Association recommends optimizing glycemic control to achieve a~     glycated hemoglobin (A1C) of less than 7% in patients with diabetes. Despite these~     recommendations, approximately 25% of patients undergoing cardiac surgery have evidence of~     suboptimal glycemic control (A1C>7%). Recent research has demonstrated that such patients~     experience a higher rate of post-operative complications and significantly worse short-term~     and long-term post-operative survival. Therefore, it is recommended that attempts should be~     made to improve glycemic control while patients wait for their elective surgery. However, at~     present processes of care that facilitate pre-operative glycemic control optimization do not~     exist in Canada.~      The objective of this project is to determine the feasibility and effectiveness of a~     comprehensive community-based pre-operative diabetes optimization program for patients~     awaiting elective cardiac surgery.~   "
133165|NCT01824264|"~     The purpose of the study is to evaluate the efficacy, tolerability and short-term safety of~     LIK066 to support dose selection for phase 3.~   "
133166|NCT01824251|"~     Patients diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy were confirmed~     based on the European Federation of Neurological Societies/ Peripheral. Nerve Society~     Guideline. Patients who meet all inclusion criteria and do not conflict with the exclusion~     criteria will receive NPB-01 (intravenous immunoglobulin) 400mg/kg/day for five consecutive~     days. Subsequently, patients receive NPB-01 1g/kg every 3weeks and evaluate the Inflammatory~     Neuropathy Cause and Treatment（INCAT） score and INCAT sensory sumscore（ISS） et al.~      As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse~     events by one year after the start of the study treatment.~   "
133167|NCT01824238|"~     This study will evaluate the effects of anacetrapib (MK-0859) on low-density~     lipoprotein-cholesterol (LDL-C) when compared to placebo in Japanese participants with~     heterozygous familial hypercholesterolemia when added to an existing statin lipid-modifying~     therapy.~   "
133168|NCT01824225|"~     Evaluate a treatment result of every two months versus as needed (PRN) after 3 initial~     monthly intravitreal aflibercept for the Japanese age related macular degeneration.~   "
133169|NCT01824212|"~     Recognition of out of hospital cardiac arrest (OHCA) during an emergency call is based on~     standardized questions concerning the symptoms of OHCA. With this method cardiac arrest is~     recognized in 50-83% of cases. When the emergency medical dispatcher identifies cardiac~     arrest during the emergency call the survival of the patient improves. Accurate emergency~     medical service response is activated promptly and bystander will receive cardiopulmonary~     resuscitation (CPR) instructions. It has been estimated that proper implementation of CPR~     instructions will save thousands of lives each year.~      If the ECG could be recorded by the mobile phone, transmitted during the emergency call to~     the dispatch centre and analysed there with the software of a semi-automated external~     defibrillator(AED), the recognition of cardiac arrest could be more accurate.~      The aim of this study is to examine, if AED, with minimal size electrodes within an area of a~     mobile phone, is able to recognize reliably ventricular fibrillation (VF), the rhythm with~     the best prognosis in OHCA.~   "
133170|NCT01824199|"~     If CYP2C19 genotype can predict the efficacy of healing erosive esophagitis and gastric acid~     secretion in patients taking once a day omeprazole.~   "
133171|NCT01824186|"~     This study aims to evaluate post-operative pain in single-incision laparoscopic~     cholecystectomy (SILC) versus the conventional four port technique (LC). The investigators~     hypothesize that SILC is non-inferior in post-operative pain.~   "
133172|NCT01824173|"~     Obesity is associated with reduced adenosine triphosphate (ATP) turnover in skeletal muscle,~     a condition that can impair muscle metabolism. The proposed research will discover mechanisms~     responsible for decreased content in mitochondrial proteins as well as in protein~     β-F1-ATPase, which is directly responsible for ATP assembly, in the muscle of obese~     individuals. This research will further examine the effectiveness of interventions, such as~     increased plasma amino acid availability and exercise, to increase the rate of production of~     mitochondrial proteins as well as that of β-F1-ATPase in the muscle of obese individuals. The~     findings will help to develop appropriate interventions to improve muscle ATP turnover and~     metabolism in obese people.~   "
133173|NCT01824160|"~     The Covered Cheatham-Platinum Stent (CCPS) is being study for repair of tears that occur in~     the pulmonary artery during dilation (enlargement) of a conduit (passageway) connecting the~     right ventricle of the heart to the pulmonary arteries. Patients undergoing replacement of~     their pulmonary valve by transcatheter technique Melody Valve) are at risk of developing such~     tears in the process of preparing the conduit to accept the new valve. In order to implant~     such a valve, the connection between the right ventricle and the pulmonary arteries often~     needs to be enlarged. High pressure balloons may be needed and these balloons can sometimes~     cause tears in or even rupture of the connecting conduit. Such tears can allow blood to flow~     into the chest and rarely this can lead to a life-threatening emergency. Experience suggests~     that such tears can be closed by implanting into the conduit a metallic stent with an outer~     covering, rebuilding the wall and allowing continuation of the valve implant.~   "
133174|NCT01824147|"~     It is the aim of the present study to assess the prevalence of ASS-Nonresponse following~     cardiac surgery using the Multiple Electrode Aggregometry (MEA).~   "
133175|NCT01824134|"~     The investigators are testing two over the counter aloe veras on irradiated breast tissue.~   "
133176|NCT01824121|"~     There is evidence suggesting that stem cells harvested from the bone marrow and transplanted~     into the brain may be effective in slowing down the progression of parkinsonism. Mesenchymal~     stem cells are able to produce growth factors that provide support to diseased nervous cells.~      In this study mesenchymal stem cells will be harvested from the bone marrow, cultivated in a~     test tube so that they multiply and then infused into the arteries that supply blood to the~     brain in 20 patients suffering from a rare form of parkinsonism, Progressive Supranuclear~     Palsy. Each patient will undergo two infusions, one with the stem cells and one without, at~     an interval of 6 months. The sequence of the two infusions will be assigned randomly;~     patients and assessors will not know the sequence (double-blind). Patients will be~     followed-up for up to 1 year after the last infusion, with regular assessments to assess~     safety, efficacy on motor and cognitive functions, and effects on the brain by neuroimaging~     techniques.~      The study has a preliminary phase with 5 patients all given stem cell therapy alone, designed~     to assess safety~   "
133178|NCT01824095|"~     The purpose of this multisite randomized controlled trial (RCT) is to compare the short-term~     (6 week) and long-term (6 month) effect of chiropractic care combined with a specific~     nutritional supplement regimen to chiropractic care with a placebo supplement for patients~     with ankle sprains, in terms of improvement in physical function and pain.~   "
133179|NCT01824082|"~     When a limb is traumatically severed, pain perceived in the part of the body that no longer~     exists often develops. This is called phantom limb pain, and is different from stump~     pain, which is pain within the part of the limb that remains intact. Unfortunately, phantom~     pain resolves in only 16% of people, with the rest experiencing this pain for the remainder~     of the lives. There is currently no reliable treatment for phantom limb pain.~      The exact reason that phantom limb pain occurs is unclear, but when a nerve is cut—as happens~     with a traumatic amputation—changes occur in the brain and spinal cord that actually worsen~     with increasing phantom pain. These abnormal changes may often be corrected by putting local~     anesthetic—termed a peripheral nerve block—on the injured nerve, keeping any bad signals~     from reaching the brain, with resolution of the phantom limb pain. However, when the nerve~     block ends after a few hours, the phantom pain returns. But, this demonstrates that the brain~     abnormalities—and phantom pain—that occur with an amputation may be dependent upon the bad~     signals being sent from the injured nerve(s), suggesting that a very long peripheral nerve~     block—lasting many days rather than hours—may permanently reverse the abnormal changes in the~     brain, and provide lasting relief from phantom pain.~      Until recently, extending a peripheral nerve block beyond 16 hours was unrealistic. However,~     a treatment option called a continuous peripheral nerve block is now available. This~     technique involves the placement of a tiny tube—smaller than a piece of spaghetti—through the~     skin and next to the nerves supplying the amputated limb. The tiny tube may be placed with~     minimal discomfort in about 15 minutes. Numbing medicine called local anesthetic is then~     infused through the tube, blocking any signals that the injured nerve sends to the spinal~     cord and brain. Using a small, portable infusion pump, this prolonged nerve block may be~     provided in individuals' own homes.~      The ultimate objective of the proposed research study is to determine if a 6-day continuous~     peripheral nerve block provided at home is an effective treatment for persistent phantom limb~     pain following a traumatic limb amputation. The primary hypothesis (what the researchers~     predict) is that phantom limb pain intensity will be significantly decreased 4 weeks~     following treatment with a 6-day continuous peripheral nerve block.~   "
133180|NCT01824069|"~     It has been demonstrated the feasibility, safety and effectiveness of mesenchymal stem cells~     derived from lipoaspirate for treating various pathologies fistula. With this project we will~     address a study population with critical ischemia of lower limbs without possibility of~     revascularization, either by technical criteria (no intervention possible to compensate for~     the lack of irrigation of a limb) criteria or risk / benefit (intolerable surgical risk for~     the type of intervention required). It will almost always elderly patients with multiple~     comorbidities and high surgical risk who have a lower limb ischemia in critical degree, with~     very high probability of major amputation in the short term or immediate.~      Hypothesis: mesenchymal stem cells obtained by lipoaspirate expanded ex vivo, are capable~     of promoting angiogenesis de novo to improve critical limb ischemia lower nonrevascularizable~     a safe manner~   "
133181|NCT01824056|"~     The objective of this protocol is to analyze the sensitivity and specificity of 18F-DTBZ PET~     to the differential diagnosis of Parkinson's disease (PD) and other parkinsonism disorders,~     including multiple system atrophy (MSA), corticobasal degeneration (CBD), and progressive~     supranuclear palsy (PSP).~   "
133182|NCT01824043|"~     Primary Objective:~      To investigate the effectiveness of intravitreal applications of 0.5 mg Lucentis~     (ranibizumab) in patients with vitreous hemorrhage due to proliferative diabetic retinopathy.~      The primary endpoint for the study will be the mean change in best-corrected visual acuity~     (BCVA) from baseline to the mean level at Month 3.~      Secondary Objectives:~        1. To assess any differences in mean change in BCVA over time;~        2. To assess differences in vitreous transparency (amount of hemorrhage) with fundus~          angiography exam;~        3. To assess any differences in retinopathy severity level according to the Early Treatment~          Diabetic Retinopathy Study;~        4. To correlate the visual outcomes with serum glucose levels.~   "
133183|NCT01824030|"~     Whether to revascularize patients with angiographically-intermediate coronary lesions (AICL)~     is a major clinical issue. Intravascular techniques (assessing either the anatomy or the~     functional effect of coronary stenoses) are routinely used to better characterize coronary~     lesions. Among these,fractional flow reserve (FFR) provides validated functional insights~     while optical coherence tomography (OCT) provides high resolution anatomic imaging. Both~     techniques may be applied to guide decisions regarding the opportunity to revascularize~     patients with AICL and to optimize the result of percutaneous coronary intervention (PCI). We~     aim to compare the clinical and the economical impact of FFR versus OCT guidance in the~     percutaneous management of patients with AICL.~   "
133184|NCT01824017|"~     The current proposal extends work done in mouse models evaluating the consistency of~     measuring RLIP76 in a clinical cohort (Aim 1) by using guidelines provided by the NIH for~     validating biomarkers. We will also proceed to estimate the effect size of a potential~     correlation of RLIP76 with standard MsY treatment measures such as hgbA1c, LDL, and~     triglyceride levels in a longitudinal prospective study ( Aim 2) that will follow a cohort of~     patients with MsY who seek care at the City of Hope Endocrine clinic over a 12 month period..~   "
133185|NCT01824004|"~     This study was conducted to evaluate the clinical outcomes and toxicities of adjuvant~     treatment including S-1/cisplatin chemotherapy followed by S-1 based CRT.~   "
133186|NCT01823991|"~     The purpose of this study is to examine the safety and influence of an intervention~     (COGNUTRIN) using nutritional supplements (n-3 fatty acids and blueberry anthocyanins) on~     cognitive performance in breast cancer survivors following chemotherapy. The investigators'~     goal is to treat or lessen the late effects of cancer treatment. The supplement to be used~     will be a combination of the following: (1) VitaBlue (40% polyphenolics, 12.5% anthocyanins~     from blueberries (BB) and (2) n-3 fatty acids - Lovaza.~   "
133187|NCT01823978|"~     This is a Phase I, non-randomized, dose escalation study of the safety, biomarkers, and~     preliminary efficacy of dendritic cell vaccine, BPX-201, plus activating agent, AP1903, in~     patients with metastatic castrate resistant prostate cancer.~   "
133188|NCT01823965|"~     In the prospective monocentric open label trial patients with diabetic macular edema will be~     treated with intravitreal injections of ranibizumab given for 3 months then with laser grid~     at month 4. During follow-up a ranibizumab injection will be performed every 2 months in case~     of best-corrected visual acuity decreased more than 5 letters.~   "
133199|NCT01823822|"~     This multicentre, randomised, double-blind, 2-parallel group, controlled trial aims to~     investigate whether oral milk protein supplements led to increase in serum Insulin-like~     Growth Factor-I levels (IGF-I) as compared with a control group fed with an iso-caloric~     supplement, in women with anorexia nervosa. Subjects receive either 150g/day of tested~     product or control product for 4-week, followed by a 4-week follow-up.~   "
133189|NCT01823952|"~     A randomized, double-blind trial in adult males with acute dehydrating diarrhea of cholera~     comparing the safety, tolerability and efficacy of HAMS HO-ORS, HAMS 2.5% Acetate HO-ORS,~     HAMS 6% Acetate HO-ORS and HO-ORS.~      The primary hypothesis is that at least one of the hypo-osmolar ORS containing high amylose~     maize starch 6% acetate (HAMSA6-HO-ORS), hypo-osmolar ORS containing high amylose maize~     starch 2.5% acetate (HAMSA2.5-HO-ORS) and a hypo-osmolar ORS containing high amylose maize~     starch (HAMS-HO-ORS), will significantly reduce diarrhea duration compared with hypo-osmolar~     (HO) ORS.~      Specifically, the investigators expect that HAMSA6 will be the most effective preparation.~   "
133190|NCT01823939|"~     This study will assess if the pharmacokinetics, safety and tolerability of iOWH032 are~     grossly different in 1) Bangladeshi healthy population and 2) Bangladeshi cholera patients.~     This is not a hypothesis-driven research study.~   "
133191|NCT01823926|"~     Introduction: Inhalation therapy has been established as an efficient route to treat asthma~     exacerbations, but coupled to noninvasive ventilation (NIV) remains quite challenging.~      Objectives: The aim of this study were to compare radiaoaerosol pulmonary index and~     radioaerosol mass balance in the different compartments (pulmonary and extrapulmonary) using~     vibrating mesh nebulizers (VMN) and jet nebulizer (JN) coupled to noninvasive ventilation~     (NIV).~      Material and methods: The investigators assessed 10 stable moderate to severe asthmatics in a~     crossover study. Patients was randomly assigned to participate in both phases of the study:~     Phase 1(NIV+MN) and phase 2(NIV+JN). DTPA-Tc99m with radioactivity of 25 miC was used to~     inhaler using JN positioned in the circuit using a T piece, particle size generation in a~     five micron range and oxygen flow tritated at eight L/min and MN was positioned in the mask,~     particle size generation in a one range and connected to electrical energy. NIV was used a~     bilevel pressure through a face mask attached with straps and pressure adjusted were 12 cmH2O~     and 5 cmH2O as inspiratory and expiratory pressures, respectively. After, radioactivity~     counts were performed using a gama camera and regions of interest were delimited. To~     calculate aerosol mass balance the investigators considered the amount of radioaerosol~     deposited into the lungs, upper airways, stomach, nebulizer, circuit, inspiratory and~     expiratory filters, and mask divided for each of these compartments and represented as a~     percentage.~   "
133192|NCT01823913|"~     This study investigates safety and pharmacokinetic comparison of G-0081, a combination tablet~     of amlodipine and valsartan (test formulation), and Exforge®, a combination tablet of~     amlodipine and valsartan (reference formulation) for single dose in healthy volunteers~   "
133193|NCT01823900|"~     This study investigates safety and pharmacokinetic comparison of DWJ1276, a combination drug~     of Rosuvastatin and Olmesartan (test formulation), and co-administration of Rosuvastatin and~     Olmesartan (reference formulation) for single dose in healthy volunteers~   "
133194|NCT01823887|"~     The ANTHEM-HF Study is designed to demonstrate the safety and efficacy of vagus nerve~     stimulation (VNS) with the Cyberonics VNS Therapy System for the treatment of subjects with~     symptomatic heart failure.~   "
133195|NCT01823874|"~     Clinical benefits of VR analgesia have been empirically demonstrated as either an alternative~     or in combination with opioids. Issues of cost, ergonomics, and maintenance of the hardware~     systems have limited the wider use of this benefit to the public. Firsthand Technology has~     designed a system to meet the performance requirements for high levels of pain control in a~     durable, ergonomic package at a greatly reduced cost compared to the current systems in use.~     This study will validate the new system by running a thermal pain study that tests the effect~     of the new system (ID) compared to the established standard helmet currently used.~   "
133196|NCT01823861|"~     An individual randomised controlled trial (RCT) to evaluate the effectiveness of a~     voice-based mobile phone health (mHealth) intervention to support post-abortion family~     planning (PAFP) at four Marie Stopes International clinics in Cambodia.~      The study seeks to address the research question: does a PAFP mHealth intervention increase~     use of contraception in Cambodia?~   "
133197|NCT01823848|"~     Functional constipation is extremely common in children and is defined as painful, hard~     stools or firm stools for twice or less per week. Functional constipation accounts for 3% of~     general pediatric visits and up to 25% of pediatric gastroenterology visits. Constipation and~     fecal impaction can lead to a range of symptoms including decreased appetite, vomiting, and~     abdominal pain frequently resulting in Emergency Department (ED) presentation. In contrast to~     the outpatient setting where diet and oral medications work well to relieve symptoms related~     to functional constipation, ED management requires an approach with quicker results. For~     immediate relief of symptoms, disimpaction via enema use may be better than polyethylene~     glycol (PEG) 3350 for children. However, the type of enema to be used is not well studied.~     Currently, any patient presenting to the ED with a presumed diagnosis of abdominal pain due~     to functional constipation receives an oral dose of PEG and one of the following three types~     of enemas (based on the ED treating attending's discretion): phosphate or Fleets enema,~     normal saline enema, or mineral oil enema. There is no evidence in the literature that~     demonstrates any difference in the effectiveness of each of these enemas. The investigators~     propose a randomized control trial of the three types of pediatric enemas readily used in our~     ED to determine the best approach. There will be three arms within this study: a) PEG plus~     phosphate enema b) PEG plus normal saline enema and c) PEG plus mineral oil enema. The~     physicians enrolling patients will not be the treating physicians. The four principal~     investigators (blinded to the type of enema being used), following appropriate informed~     consent, will obtain pain scores (Faces Pain Scale - Revised) pre- and post-administration of~     each of the three treatments listed above in order to determine the best enema to use in~     children 4-12 years of age. Other outcomes to be analyzed will include the patient's weight~     pre- and post-administration of the enema, satisfaction ratings on a visual analog scale from~     the treating physician (who will also be blinded), and parental surveys on the day of~     administration and 3-5 days following discharge. Data analysis for pain scores will be~     completed with repeated measures anova. Categorical values will be compared using Chi Square~     analysis and continuous variables will be compared using parametric statistics.~   "
133198|NCT01823835|"~     This study is a multi-institution, Phase Ia/Ib/IIa open-label, dose-finding, safety,~     pharmacokinetics (PK), and proof-of-concept study of GDC-0810 as a single agent and in~     combination with palbociclib and/or LHRH agonist. The study is divided into 3 phases: Phase~     Ia, Phase Ib, and Phase IIa. During Phase Ia (dose escalation phase), GDC-0810 single agent~     will be administered orally on a continuous daily dosing regimen with a Day -7 lead-in period~     for single dose PK evaluation prior to the start of daily treatment. The incidence of~     dose-limiting toxicities (DLTs) will be evaluated from Day -7 through the first cycle (28~     days) of treatment (35 days total). Depending on safety and tolerability, participants will~     be assigned sequentially to escalating doses of GDC-0810 using standard 3 + 3 design. During~     Phase Ib (dose escalation and expansion phase), participants will receive GDC-0810 with~     palbociclib and/or LHRH agonist to determine the recommended Phase II dose (RP2D) and assess~     the safety and tolerability of concomitant administration. During Phase IIa (dose expansion~     phase), participants previously treated with an aromatase inhibitor (AI) will be treated at~     the RP2D to further characterize the safety, PK, pharmacodynamics, and anti-tumor activity of~     GDC-0810.~   "
133200|NCT01823809|"~     The purpose of the study is to assess the diagnostic accuracy of a combined use of~     non-invasive coronary angiography with multi-slice computed tomography (MSCT) and stress~     cardiac magnetic resonance (CMR) imaging in patients with obstructive lesions on MSCT and~     with low to intermediate pre-test likelihood of coronary artery disease (CAD) as compared to~     invasive coronary angiography (CAG) and Fractional Flow Reserve (FFR) measurements.~   "
133201|NCT01823796|"~     Fibromyalgia is a chronic illness characterized by persistent widespread muscle pain with~     generalised hyperalgesia and allodynia. It can be accompanied by other concomitant symptoms:~     fatigue, sleep disturbances, musculoskeletal disorders, distress and psychological disorders.~     The prevalence has been reported to be between 2 and 5%.~      The hypothesis of this study is that women with fibromyalgia present high risk of falls and~     balance disorders compared with healthy women. The objective of this study was to investigate~     wether gait pattern changes in single and dual task conditions were associated with the risk~     of falling in women with fibromyalgia.~   "
133202|NCT01823783|"~     Duchenne muscular dystrophy (DMD) is the most common and devastating form of muscular~     dystrophy, caused by an X-chromosome gene mutation resulting in the absence of the protein~     dystrophin. Gene therapy by exon skipping or stop codon read-through and cell therapy are at~     the stage of clinical assays with very promising results. Nevertheless, they will not allow a~     complete cure of DMD patients and they will concern only specific types of mutations. It is~     therefore crucial to develop other therapeutic strategies related to the natural history of~     the disease and targeted not on the dystrophin itself, but on the consequences of its~     absence.~      Another crucial pathophysiological pathway in DMD is muscle cell calcium homeostasis,~     particularly via the ryanodine recepteur (RyR1).~      Our study focus on the relationship between endomysial fibrosis, abnormal inflammation~     response and calcium homeostasis dysfunction which are not entirely established in DMD.~      The identification of the biological mechanisms that play a role in the severity of the~     phenotype, particularly endomysial fibrosis, should allow the development of targeted~     pharmacotherapy as a complementary strategy for the future treatment of DMD.~   "
133203|NCT01823770|"~     Several studies report association between restless legs syndrome (RLS), HTA and~     cardiovascular diseases .~      The mechanisms involved in this relationship remained unknown, but several evidences favor~     the role of periodic limb movements in sleep (PLMS), patterns frequently associated with RLS.~     Sympathetic overactivity is associated with PLMS with increased pulse rate and blood pressure~     coincident with PLMS. PLMS-related repetitive nocturnal blood pressure fluctuations could~     contribute to the risk of high blood pressure, heart disease, and stroke in patients with~     RLS, especially in the elderly. Several studies already reported that dopaminergic agonists~     reduce the severity of RLS and the PLMS index.~      Do dopaminergic agonists reduce the risk of cardiovascular diseases and associated autonomic~     dysfunctions in patients with RLS ?~      Nocturnal BP (blood pressure) decline has major clinical implications, and the loss of normal~     reduction in BP during sleep is associated with high risk of cardiovascular morbidity and~     mortality.~      The main aim of this study was to evaluate the impact of rotigotine patch treatment on~     validated cardiovascular risk factors ambulatory BP during night, day and night-to-day ratio,~     and endothelial function in patients with idiopathic RLS compared to placebo.~   "
133204|NCT01823757|"~     This study investigates the effect of pharmaceutical care on a Veteran nursing home. 100~     patients will be selected into this controlled study.The hypothesis are:~        1. After patients receive pharmaceutical care, their drug related problems will be~          decreased.~        2. After patients received pharmaceutical care, their self-reported medical expenditure~          will be decreased.~   "
133205|NCT01823744|"~     The purpose of this trial is to better define how individuals with different genetic make-ups~     will require different interventions to improve their methylation potential and nutrient~     status.~   "
133206|NCT01823731|"~     objectives: To development of NCC-PCI-Operative Template (NPOT) for the objective description~     of perioperative tumor burden and surgical approaches in the management of ovarian cancer,~     tubal cancer, and primary peritoneal cancer~   "
133207|NCT01823718|"~     Patients patients enrolled in this study have a Lymphoma caused by EBV (after bone marrow~     transplantation, organ transplantation or patient immunodeficient.~      They will receive one to three injections of allogenic CTL specific EBV.~      The purpose of this study is to ensure that these injections can not cause a GVH and to study~     what the side effects are and to see whether this therapy might help patients with Lymphoma.~      Immunological monitoring will also be studied.~   "
133208|NCT01823705|"~     The purpose of this feasibility study is to provide safety data on the implantable Exilis~     gastric electrical stimulation (GES) system, to individually adjust stimulation parameters to~     levels that are comfortable for implanted subjects during chronic daily treatment, and to~     collect data on acute gastrointestinal function and food intake responses to GES during~     in-clinic testing.~   "
133209|NCT01823692|"~     The purpose of this study is to evaluate whether ultrasonography guidance compare with the~     simple radiography aids in determining the adequacy of distal radius fracture reduction.~   "
133210|NCT01823679|"~     Phase 2 evaluation of capecitabine in patients with advanced or recurrent squamous cell~     carcinoma of the skin.~   "
133211|NCT01823666|"~     Mild cognitive impairment (MCI) is believed to be the early stage of dementia. The~     investigators assume that some psychological and imaging risks may predict the conversion. In~     the current longitudinal study, psychological and imaging data of people with MCI will be~     obtained at baseline, and will be followed at 26 weeks and 52 weeks. The predictors will be~     found in comparison with controls.~   "
133212|NCT01823653|"~     The purpose of this study is to assess the safety and efficacy of treatment with the~     Liposonix System (Model 2) for the circumferential reduction of subcutaneous adipose tissue~     (SAT) of the thighs.~   "
133223|NCT01823510|"~     The purpose of this study is to determine whether treatment with ticagrelor + aspirin is more~     effective than treatment with clopidogrel + aspirin in patients with type-2 diabetes. Both~     treatments will be given (separately) to all subjects as a one-time loading dose (i.e. higher~     than a normal daily dose), followed by daily dose for the next 5 to 7 days. Effectiveness of~     treatment will be measured with specialized blood tests before the loading dose, at two~     time-points after the loading dose, and once after the last daily dose.~   "
133213|NCT01823640|"~     Our primary objective is to set up the Human Rhinovirus (HRV)-model in our centre. In~     addition, to facilitate future clinical trials, we want to determine optimal read-out~     parameters and read-out time points for experimental HRV infection in healthy volunteers.~     Furthermore, we want to analyze to what extent HRV can cause systemic immune effects, and we~     want to test if subjects with antibodies against HRV can be re-infected with the same virus,~     and if the presence of HRV antibodies influences the local clinical and immunological~     response upon infection. Additionally, to gain insight in the immune modulating properties of~     HRV, we want to investigate the immunological response to a HRV re-infection within one week~     to determine if there are mechanisms that provide immediate protection against re-infection.~     This facilitates a cross-over design of future pharmacological intervention-trials.~     Furthermore, we want to investigate the capacity of HRV infection to modulate the systemic~     immune response by analyzing the response of leukocytes ex vivo stimulated with different~     stimuli. Moreover, we want to evaluate the effects of HRV-16 infection on the host~     transcriptome and metabolome. Finally, The influence of HRV-16 infection on nasal and gut~     microbiota will be assessed.~   "
133214|NCT01823627|"~     Purpose: Patients with mental health disorders have a reduced life expectancy, compared to~     the general population. The shorter life expectancy is caused by natural and unnatural death.~     In general, patients with a mental disorder tend to have a more unhealthy lifestyle, than the~     general population, characterized by e.g. lack of exercise and smoking.~      Hypothesis~      Chronic obstructive pulmonary disease (COPD) is underdiagnosed in psychiatric inpatients~     There is a higher prevalence of COPD in psychiatric inpatients compared to the general~     population Screening of patients with one respiratory symptom and a smoking history, has the~     same sensitivity regarding to diagnosis of COPD, as screening all patients with a smoking~     history~      Method:~      80 psychiatric inpatients will undergo spirometry with reversibility test and COPD Assessment~     Test (CATest). Furthermore, patient history regarding respiratory symptoms and smoking will~     be taken into account.~   "
133215|NCT01823614|"~     To date, all work related to the study of HIV tropism, was performed on HIV B and C subtypes.~     In the studied samples, HIV variants of subtype A were virtually absent. However, the~     existence has been shown previously of some differences in the nucleotide sequences in the V3~     loop of env region of subtype A from other subtypes of virus. In the Russian Federation the~     subtype A of HIV-1 is predominant, and, according to some estimates, accounts for about 89%~     of all newly diagnosed cases of HIV infection. Thus, it seems interesting and effective to~     study the characteristics of HIV-1 subtype A, associated with the tropism, in the Russian~     Federation.~      The primary objective is determination of the prevalence of R5 (chemokine receptor 5), X4~     (chemokine receptor 4), and R5X4-tropic variants of HIV in HIV-infected population in Russia,~     and analysis of the possible features of tropism of viruses belonging to subtype A.~   "
133216|NCT01823601|"~     The aim of present study is to evaluate whether a program of behavioral and cognitive~     procedures for emotional control, and assertive training, produces well-being and improvement~     in quality of life of healthy volunteers.~   "
133217|NCT01823588|"~     A number of strategies have been evaluated to improve the prevention and control of the main~     cardiovascular (CVD) risk factors. Nursing telephonic and tele-counseling individualized~     lifestyle educational programs were found to improve blood pressure (BP) control and~     adherence to healthy lifestyle. This study aims at evaluating for the first time the efficacy~     of a nurse-led reminder program through email (NRP-e) to improve CVD risk factors among~     hypertensive adults.~      Participants will receive usual care and a guideline-based educational program on BP control~     and healthy lifestyle habits. Subjects in the NRP-e group will also receive weekly email~     alerts and phone calls from a nurse care manager for 6 months. Emails contain a reminder~     program on the compliance with a healthy lifestyle based upon current guidelines for CVD~     prevention. Follow-up visits will be scheduled at 1, 3 and 6 months after enrollment;~     randomization will be made centrally and blood samples will be evaluated into a single,~     accredited laboratory.~   "
133218|NCT01823575|"~     Malignant ureteral obstruction often necessitates chronic urinary diversion and is associated~     with high rates of failure with traditional double-J ureteral stents. To overcome drawbacks~     of the double-J stent, recently, metallic stents have been used to manage for palliative~     treatment in patients with ureteral obstruction associated with end stage malignant disease.~     The success rates of metallic stents have been reported to be high and the method proved to~     be useful in patients with malignant ureteral obstruction. In addition, covered metallic~     stents have many advantages compared with bare metallic stents, such as lower rate of tissue~     invasion and higher patency rate. However, there is little investigation about comparison of~     clinical efficacy between covered-metallic stents and double-J stents in malignant ureteral~     obstruction.~      Therefore, investigators plan to perform a prospective randomized study to compare clinical~     efficacy of silicone-covered metallic ureteral stent and double-J ureteral stent in patients~     with malignant ureteral obstruction.~   "
133219|NCT01823562|"~     This Phase I/Ib trial is studying the absorption and metabolism of phytochemicals found in~     black raspberries in men undergoing surgery for prostate cancer. This knowledge will help us~     design future chemoprevention studies and assist in making future dietary recommendations for~     men at high risk for prostate cancer.~   "
133220|NCT01823549|"~     This study was a survey to determine the frequency of Complementary and Alternative Medicine~     (CAM) use in patients recently diagnosed with breast or prostate cancer who were starting~     radiation therapy. The survey was repeated at three time points to assess changes in CAM use~     over time.~   "
133221|NCT01823536|"~     In this extension study, V59P20E1, the sponsor was planning to assess 5-year antibody~     persistence in subjects who received one or two doses of MenACWY conjugate vaccine at 2 to 10~     years of age, and to evaluate response to a booster dose administered 5 years after primary~     vaccination in the parent study V59P20 (NCT00616421).~   "
133222|NCT01823523|"~     Currently there is debate in the literature as to the recommended length of postoperative~     antibiotics in patients undergoing orthognathic surgery. The investigators plan to~     investigate using a randomized controlled trial the comparison between a 1 day and 3 day~     regimen of antibiotics and the effects on post operative infection.~   "
133254|NCT01823107|"~     The purpose of the study is to evaluate the safety and feasibility of the use of Meso~     BioMatrix Acellular Peritoneum Matrix for the reinforcement of weakened soft tissue during~     2-stage, tissue expander assisted breast reconstruction.~   "
133224|NCT01823497|"~     The aim of this study is to examine the safety and effectiveness of 2 morphine delivery~     systems for post-surgical neonates. The investigators hypothesize that this study will be~     feasible to conduct, and that neonates receiving morphine via a Parent/Nurse Controlled~     Analgesia pump will receive less morphine and experience fewer side effects than neonates~     receiving morphine via continuous opioid infusion.~   "
133225|NCT01823484|"~     Compared with AN69 hemofilter, AN69 ST hemofilter may prolong the time of hemofilter and~     decrease the quantity of heparin during continuous renal replacement therapy in critically~     ill.~   "
133226|NCT01823471|"~     Hereditary non-polyposis colon carcinoma (HNPCC or Lynch-Syndrome) is a rare cause of~     colorectal cancer caused by a gene defect in the so -called mismatch repair genes. Patients~     can present at young age with colorectal cancer and polyps can develop faster to malignant~     lesions in comparison to classical sporadic adenomas. New advanced imaging modalities with~     high definition images and virtual chromoendoscopy have a theoretical advantage to improve~     detection and to increase polyp detection. In patients with HNPCC polyp detection has been~     shown to be increased by classical chromo-endoscopy and by high definition endoscopy with~     narrow band imaging (NBI) (a virtual chromo-endoscopy modality activated by a button on the~     endoscope), in comparison to white light endoscopy. However, in these back-to-back studies~     there was no randomization for the order of imaging modality. It is therefore not clear~     whether really the image enhancement adds to increased polyp detection or if this is achieved~     by a second inspection of the mucosa. In this trial the investigators want to assess the real~     additional value of virtual chromo-endoscopy for polyp detection in patients with the Lynch~     syndrome. The investigators will use the high definition pentax system and will compare white~     light endoscopy to i-scan, the incorporated virtual chromo-endoscopy mode in this system.~   "
133227|NCT01823458|"~     Incentives are increasingly being used to motivate health behavior in medical studies. Small~     cash payments conditional on certain health and welfare promoting behaviors have shown~     efficacy in both real world and experimental settings. Furthermore, in incentive studies,~     behavioral economics has been shown to amplify behavior change beyond what is possible with~     simple cash payments, but little is known about how varying incentive payment design may~     impact health behavior. The goal of the present study is to evaluate a new incentive payment~     instrument, lottery insurance, to determine its impact on adherence to the target health~     behavior, attendance at free exercise classes provided by QueensCare Family Clinics, a~     safety-net medical clinic.~   "
133228|NCT01823445|"~     The purpose of this study is to demonstrate whether decay causing bacteria are reduced when~     adhesive xylitol disks are used intraorally three times a day for two weeks in adults with~     dry mouth.~   "
133229|NCT01823432|"~     Bicuspid Aortic Valve (BAV) is the most common congenital heart malformation in adults, but~     very little is known about the genetic causes or risk factors for adverse outcomes.~     Currently, it is estimated that most cases of aortic stenosis in patients less than 65 years~     old are caused by BAVs. BAV patients are also at high risk to develop aneurysms of the~     ascending aorta, which may lead to aortic dissections. Dr. Prakash and his colleagues plan to~     use individual genetic information to identify persons with BAV who are at high risk for~     complications and to customize therapies.~   "
133230|NCT01823419|"~     The purpose of this study is to investigate the role of the ratio of omega-6 to omega-3 fatty~     acids on executive functions. The investigators hypothesize that participants ages 7-9 years~     with a ratio closer to 4:1 will do better on tests of executive function than participants~     with a ratio closer to the purported Western diet norm of 15:1.~   "
133231|NCT01823406|"~     We will perform blood sugar studies to assess changes in metabolic (biochemical processes~     that occur within us) profiles associated with high blood sugar and diabetes.~   "
133232|NCT01823393|"~     To assess if the non use of heparin sodium during balloon aortic valvuloplasty reduces~     serious complications due to the procedure, by decreasing the rate of vascular and~     hemorrhagic complications without increasing the rate of ischeamic events.~   "
133233|NCT01823380|"~     The main objective of this study is to investigate the correlation between the rate of motor~     decline and blood levels of Vitamin D total. Secondary objectives are to investigate the~     relationship between blood levels of vitamin D and total disease duration of ALS, forced~     vital capacity, weight loss, age of onset and the start site of ALS.~   "
133234|NCT01823367|"~     This study is a randomized intervention that will test two different approaches reflecting~     diverse levels of both intensity and cost, to achieving risk reduction of T2D. This will help~     address a critical question in the translation of primary prevention research into the public~     health: how much intensity (and thus cost) is required to achieve an effective outcome? In~     addition, the proposed study will address a critical need in diabetes prevention that has not~     received sufficient scholarly attention: the prevention of T2D in children. No studies of~     diabetes prevention similar in scope to the DPP have been performed in school-aged children;~     however, reducing childhood obesity is widely accepted as the primary pathway to decreasing~     the growing prevalence of T2D in the pediatric population.~   "
133235|NCT01823354|"~     Restless leg syndrome (RLS) is a common neurological disorder whose diagnosis is only~     clinical. The efficacy of dopaminergic agents in improvement of sensorimotor symptoms advance~     the hypothesis that altered dopaminergic transmission is at the origin of this condition. RLS~     usually leads to a sleep fragmentation, which induces sometimes severe insomnia most often~     associated, in clinical practice, to a cognitive complaint (attentional in nature). Executive~     functions in which dopaminergic transmission is heavily involved refer to a set of complex~     functions. At least three of them should be considered during their evaluation (ie~     flexibility, inhibition, and the updating of working memory). These functions are among the~     targets of the alteration of the quality and quantity of sleep. The few studies that have~     focused on the study of the integrity of executive functions in RLS have discordant results.~     The lack of control of key variables in the assessment of executive functioning (ie~     intellectual performance, depressive symptomatology, generalized slowing in information~     processing) and the lack of reference in the theoretical approach in executive functions are~     certainly the two main reasons. Moreover, the question of polysomnographic correlates and the~     reversibility of these cognitive abnormalities after pharmacological management of RLS~     remains unanswered today.~      The main objective of this study is to compare the executive performance of untreated RLS~     patients with a group of matched controls.~   "
133236|NCT01823341|"~     The purpose of this study is to see whether low blood sugar at night can be reduced by using~     a system that turns off the insulin pump automatically. The study system includes a~     continuous glucose monitor (CGM) and an insulin pump. The CGM and pump work with a regular~     laptop computer. A The system works by (1) measuring the glucose levels under the skin with~     the CGM, (2) using a computer program on the laptop to predict whether a low blood sugar is~     likely to occur, and (3) turning off the insulin pump when the computer program predicts that~     a low blood sugar will occur.~      We have tested the system in the home environment in individuals with type 1 diabetes age 15~     years and older. We have found an indication that the system can decrease the frequency of~     hypoglycemia. We have not had any serious cases of high blood sugars or other problems. We~     are now ready to further test the system in the home environment in a younger age group to~     learn more about its ability to reduce overnight low blood sugar risk.~      This study has several phases and will take about 3 months for a patient to complete.~        -  First, the patient will use the CGM and pump at home for up to 15 days with the help of~          a parent/guardian. This is done to determine if the patient meets our study criteria to~          proceed with the next phase of the study.~        -  If the patient is eligible to continue in the study, the patient will need to use the~          full study system for at least 5 nights at home with the help of a parent/guardian. This~          is done to make sure the patient and parent/guardian are able to use the system~          correctly. The patient may participate in starting and stopping the system at home, but~          the parent/guardian is responsible for making sure it is used as instructed.~        -  After that, the patient will be asked to use the study system each night for an~          additional 6 to 8 weeks. The parent/guardian will remain responsible for making sure the~          system is used as instructed.~      The study will include about 90 individuals with type 1 diabetes at 3 clinical centers in the~     United States and Canada. First a study of children 8 to less than 15 years old will be done.~     Then, a study of children 3 to less than 8 years old will be conducted.~   "
133237|NCT01823328|"~     The purpose of this study is to compare the effectiveness and safety of ketamine and~     etomidate during rapid sequence intubation (RSI).~   "
133238|NCT01823315|"~     The investigators will conduct a trial to determine whether methotrexate single-dose~     treatment and methotrexate/Actinomycin-D single-dose treatment work well as multiple courses~     of single agent chemotherapy in low-risk gestational trophoblastic neoplasia.~   "
133239|NCT01823302|"~     The primary objective of the study was to compare the change in z-scores for growth during a~     120-day study period in children with picky eating behaviors who were randomly assigned to~     receive nutrition counseling only (control group) or nutrition counseling plus an oral~     milk-based nutritional supplement (study group). The secondary objectives of the study were~     to compare the following between the control and study groups: a) dietary macro- and~     micro-nutrient intakes; b) quantitative ultrasound bone measurements of radius and tibia; and~     c) incidence of common illnesses (diarrhea, upper and lower respiratory tract). The safety~     objective of the study was to compare the frequency of adverse events (AE) among the control~     group and study group subjects.~   "
133240|NCT01823289|"~     The purpose of this study is to evaluate the efficacy and safety of itraconazole sequential~     therapy (intravenous injection/oral solution) in participants with invasive pulmonary fungal~     infections ([IPFI]; lung diseases caused by fungal infection).~   "
133241|NCT01823276|"~     The objective of the proposed research is to determine if tyrosine, an amino acid found in~     protein-containing foods, will mitigate the cognitive deficits and adverse effects on~     behavior and mood produced by exposure to military stress. This study will be conducted at~     the Army Survive, Evade, Resist, Escape (SERE) school at Fort Bragg, NC.~      Tyrosine is the dietary precursor of the catecholamine norepinephrine, a key brain~     neurotransmitter that is critical for the central nervous system (CNS) response to various~     types of acute stress. Psychological stress increases catecholamine turnover in the brain,~     increasing the requirement for tyrosine to support synthesis of norepinephrine. Animal and~     human studies have shown that tyrosine supplementation can produce beneficial effects on~     cognitive and physiological functions during exposure to a variety of acute stressors.~      This project will determine if volunteers treated with supplemental tyrosine during stressful~     phases of SERE training experience less degradation in cognitive performance and mood than~     volunteers treated with placebo. Tyrosine or placebo will be administered in a specially~     developed food bar provided to volunteers. The bar is part of a prototype of ration-component~     designed for use during assault operations. A between-subjects, double blind experimental~     design will be employed. Tyrosine, an amino acid found in most protein-containing foods, has~     been tested in hundreds of volunteers without adverse effects.~      Approximately 100 volunteers will be recruited from several SERE classes to ensure up to 82~     volunteers complete the study. They will be tested during several portions of SERE. A~     comprehensive but brief battery of cognitive tests, as well as saliva and blood samples, will~     be collected in a manner that does not interfere with ongoing training.~      Hypotheses:~        1. The adverse effects of psychological stress on cognitive performance and mood during~          SERE school will be reduced when volunteers are given supplemental tyrosine compared to~          placebo treatment.~        2. Supplemental tyrosine will reduce release of proinflammatory cytokines that may be~          increased by the stressful activities of SERE school.~   "
133242|NCT01823263|"~     The purpose of this study is to determine whether partial sleep deprivation, as compared with~     normal sleep, influences certain metabolic and cognitive parameters, related to food intake,~     hunger and memory functions, when participants are shielded from external time cues.~   "
133243|NCT01823250|"~     This Stage II randomized trial tests Culturally Informed & Flexible Family Based Treatment~     for Adolescents (CIFFTA) developed as part of a Stage I treatment development effort and~     yielding promising preliminary findings. Drug use rates are highest among Hispanic middle~     school youth and to date no treatments have met criteria for Well Established in the~     treatment of substance abuse in Hispanic adolescents. Further treatment for Hispanic youth~     and families is complicated by the fact that these families often differ from mainstream~     populations in culture-related values, beliefs and behaviors that can directly impact~     engagement, retention, and efficacy/effectiveness of drug treatment. Our efforts to develop a~     more powerful treatment capable of addressing these issues began with a Stage 1 study that~     led to the development of a multi-component treatment that includes a flexible manual that~     allows treatment tailoring to the unique characteristics of individual families. CIFFTA~     integrates innovative culturally-based, individually-based, and family-based components to:~     1) reduce maladaptive family processes (e.g., poor parenting practices, family conflict) and~     increase family protective factors (e.g., strong parent-child attachment), 2) teach~     adolescents skills to effectively manage interpersonal conflicts and stressors and to~     increase motivation to change, 3) deliver psycho-educational and culturally congruent~     material (e.g., modules on immigration stressors) to youth and parents both separately and~     together, and 4) deliver the intervention using a flexible treatment manual that allows the~     clinician to tailor the treatment (e.g., by selecting the most relevant psycho-educational~     modules and themes) to the unique characteristics and needs of the Hispanic family.~      This Stage II randomized trial randomizes 220 Hispanic adolescents ages 14-17 who meet DSM-IV~     criteria for Substance Abuse to a 4-month treatment of either CIFFTA or Traditional Family~     Therapy. The study tests CIFFTA's efficacy in impacting drug use, risky sexual behavior, and~     other severe behavior problems, and hypothesized mechanisms of change, in a larger and more~     rigorous Stage II trial. Assessments occur at baseline, 4 months post baseline (end of~     treatment), 10 months post baseline and 16 months post baseline. Should this line of research~     continue to be successful, it has the potential to contribute to the field a highly~     innovative and efficacious treatment for Hispanic drug abusing adolescents, a better~     understanding of mechanisms of treatment efficacy, and also a framework for future flexible~     and tailored treatments that can be used to better address the unique needs of other special~     populations.~   "
133255|NCT01823094|"~     Investigators hope to learn more about how to use computed tomography (CT) scans to measure~     blood flow in lung tumors and how it may change in response to treatment. This measurement~     technique is called computed tomography perfusion (CTP). CT scanners use X-rays to produce~     3-dimensional images of the body.~      Currently, doctors determine the response to treatment by measuring the size of the tumor.~     Investigators are trying to find out if measuring the blood flow in the tumor is equal to or~     better than measuring the size of the tumor.~   "
133256|NCT01823081|"~     Eligible eyes are randomized to two groups. Group A will receive three intravitreal~     injections of bevacizumab at 4 week intervals. In group B, three intravitreal injections of~     combined bevacizumab and fasudil will be performed with the same frequency.~      Best corrected visual acuity (BCVA) and central macular thickness (CMT) will be evaluated~     prior to injections and then every 4 weeks for 6 months. Fluorescein angiography will be~     performed at baseline and at weeks 12 and 24. The two groups will be compared in terms of~     BCVA and CMT changes.~   "
133244|NCT01823237|"~     Dystonia is a disease where muscles in the affected body part are abnormally active. This may~     result in abnormal postures. The underlying mechanisms are not known. One proposed mechanism~     is located in the motor area of the brain that controls the coordination of muscles, called~     the motor cortex. It is well known that the motor area of one hemisphere of the brain (motor~     cortex) controls the movement of the opposite side of the body. When people perform tasks~     such as picking up an object or writing there are mechanisms in motor cortex that focus the~     level of activity so that they can do these tasks with a high level of precision. Focusing~     activity in motor cortex seems to be disturbed in people with dystonia. Transcranial magnetic~     stimulation (TMS) is a device that allows the non-invasive stimulation of the brain. When~     applied to the motor cortex it can upregulate or down regulate its activity. In the present~     study the investigators will conduct experiments on subjects with task specific focal hand~     dystonia (such as writers cramp) using TMS to decrease unwanted motor activity. The~     investigators will assess the effects of this intervention using objective, subjective and~     kinematic measures. This is a pilot study and will require further research to assess the~     long-term effects of repetitive TMS on task-specific focal hand dystonia.~   "
133245|NCT01823224|"~     The purpose of the study is to learn whether perioperative IV (intravenous) administration of~     acetaminophen (commonly referred to as Tylenol) shows any different clinical outcomes over~     the oral (by mouth) administration of acetaminophen for a patient having a laparoscopic~     cholecystectomy. If improved pain scores occur with the administration of IV acetaminophen,~     it may result in fewer requests for pain-related intervention such as other oral pain~     medications.~   "
133246|NCT01823211|"~     The purpose of this study is further risk stratification of patients receiving implantable~     cardioverter-defibrillator in primary prevention of sudden cardiac death.~   "
133247|NCT01823198|"~     Any time the words you, your, I, or me appear, it is meant to apply to the potential~     participant.~      The goal of this clinical research study is to find the highest tolerable dose of immune~     cells called natural killer (NK) cells that can be given with chemotherapy and a stem cell~     transplant to patients with AML and MDS. Researchers want to learn if adding NK cells will~     help make the stem cell transplant more effective in treating the disease. The safety of this~     treatment will also be studied.~      NK cells may kill cancer cells that remain in your body after your last chemotherapy~     treatment. The NK cells will be separated from blood from a relative of yours or from~     umbilical cord blood. These separated NK cells will then be grown in the lab to increase the~     number of NK cells that can be given to you by vein.~      The chemotherapy given on this study will consist of the following drugs:~        -  Busulfan is designed to kill cancer cells by binding to DNA (the genetic material of~          cells), which may cause cancer cells to die. Busulfan is commonly used in stem cell~          transplants.~        -  Fludarabine is designed to interfere with the DNA of cancer cells, which may cause the~          cancer cells to die.~        -  IL-2 (interleukin-2) is a naturally occurring protein (cytokine) that can enhance NK~          cell function.~      This is an investigational study. Busulfan, fludarabine, and IL-2 are FDA approved and~     commercially available for the treatment of other types of cancer. Their use for the~     treatment of AML and MDS is investigational. The use of NK cells is investigational. The NK~     cell process is not FDA approved or commercially available. It is currently being used for~     research purposes only.~      Up to 72 patients will take part in this study. All will be enrolled at MD Anderson.~   "
133248|NCT01823185|"~     Clopidogrel is crucial as antiplatelet treatment in patients undergoing percutaneous coronary~     intervention (PCI) with stent implantation and during one year after PCI, to prevent~     atherothrombotic complications. However, clopidogrel is ineffective in certain patients due~     to genetic mutation in CYP2C19 gene a specific enzyme in the liver required for metabolism of~     clopidogrel. Therefore, the purpose of this study is to test these patients genetically at~     bedside and prescribe an alternative drug such as Ticagrelor (90 mg twice daily) or prasugrel~     ( 10mg once daily or 5mg once daily if the patient older than 75 years or a body weight <~     60kg) if they are carriers of the allele 2 or 3 of the mutated gene.~   "
133249|NCT01823172|"~     The investigators plan to study the ability to identify the lymph nodes beyond the sentinel~     lymph node that may harbor cancer using methylene blue dye.~   "
133250|NCT01823159|"~     The objective of this study is to characterize the effects of a single-dose of retigabine on~     cortical excitability in healthy subjects, as quantified by means of TMS.~   "
133251|NCT01823146|"~     This study will investigate the extent to which intranasal oxytocin affects changes in social~     decision making and evaluations of others. Oxytocin is a hormone that naturally occurs in the~     body and the brain and has been shown to be relevant for many behaviors, particularly in~     social situations. Research on the effects of oxytocin in aging is very scarce; therefore,~     the purpose of this research project is to determine the effects of oxytocin on~     socioemotional aging.~   "
133252|NCT01823133|"~     Investigate the pharmacokinetic drug interactions between gemigliptin and rosuvastatin in~     healthy subjects~   "
133253|NCT01823120|"~     Between 6% and 30% of people who harm themselves repeat this self-harm within the following~     12 months. The investigators know that people who harm themselves are much more likely to~     commit suicide, but the investigators have no clear evidence about the best way to reduce the~     likelihood of someone harming themselves again.~      Text messaging is now a common form of communication. Previous research has shown us that the~     investigators can use text messages for different types of health care interventions.~     Examples of this include reminding patients of medical appointments, delivering test results,~     to check patient side effects following treatment and to reduce depressive symptoms in~     patients with depression and alcohol problems. The Samaritans have introduced interactive~     text messages (where you can have a conversation by text with their service) and have noted~     an increasing use of this contact with their service.~      This research study is taking place to find out if using supportive and interactive text~     messages can reduce further episodes of self-harm in patients who present to the Emergency~     Department (ED) with self-harm.~      The investigators hypothesize that supportive, informative and interactive text messages~     delivered to patients discharged from an ED after an episode of self-harm will significantly~     reduce the frequency and intensity of thoughts of self-harm and self-harming behaviour in~     patients compared with those receiving only follow-up treatment as usual. A secondary~     hypothesis is that patients receiving the text messages will report a favourable experience~     and an overall satisfaction with the system.~   "
133257|NCT01823068|"~     The purpose of this study is to investigate the efficacy and safety of vandetanib, in~     patients with advanced non-small-cell lung cancer harboring RET gene rearrangement. In 2011,~     gene rearrangement between RET and KIF5B gene (fusion) was discovered in a young, male lung~     cancer patient. The following studies showed that this gene rearrangement was critical for~     tumor initiation and maintenance. Of note, the growth and signaling properties mediated by~     KIF5B-RET were diminished after treatment with vandetanib.~      Until now, RET rearrangements have been known in thyroid cancers. Vandetanib, a multi-kinase~     inhibitors with anti-RET activity, is an FDA-approved drug for the treatments of adults with~     metastatic medullary thyroid cancers who are ineligible for surgery and who have progressive~     or symptomatic disease. This study aimed to examine the efficacy and safety of this drug, for~     the treatment of advanced lung cancer harboring RET rearrangement.~   "
133258|NCT01823055|"~     To perform a clinical safety and efficacy assessment of the Uphold LITE system for pelvic~     organ prolapse in a prospective multicenter, single cohort study.~   "
133259|NCT01823042|"~     Crohn's disease(CD) is a agnogenic disease which has a lifelong relapse tendency even after~     surgery treatment.So maintain remission medications were routinely given to patients after~     surgery.But maintain remission medications,as azathioprine,6-MP, ciclosporin,tripterygium~     glycosides, had a onset time.The therapeutic effect may appear 3 months~6months after taken~     medicine.There is a treatment blank period between surgery and onset time of maintain~     remission medications.Enteral nutrition has been used in the induction remission and maintain~     remission for CD.May be it can fill the treatment blank period.~   "
133260|NCT01823029|"~     Extra iron may not be necessary in the treatment of iron deficiency anemia in Crohn's~     Disease;Oxidative Stress and Inflammation may be Caused by Intravenous Iron in Crohn's~     Disease Patients With Iron Deficiency Anemia.~   "
133261|NCT01823016|"~     The purpose of this study is to evaluate the efficacy, safety, tolerability, pharmacokinetics~     (PK), and pharmacodynamics (PD) of JNJ-38518168 compared with placebo in participants with~     persistent asthma that is inadequately controlled despite current treatment.~   "
133262|NCT01823003|"~     This study is designed to evaluate the safety of Stereotactic Ablative Radiotherapy (SBRT) in~     selected patients with stage I Non Small Cell Lung Cancer (NSCLC) or metastatic lung cancer~     to demonstrate the feasibility and risks of using an ablative dose-adapted scheme with FFF~     beams. Other aims are To evaluate the incidence of acute and late complications; To evaluate~     tumour response to local radiation therapy by means of CT, PET/TC and MRI and To evaluate the~     impact of local therapy on overall and disease-free survival.~   "
133263|NCT01822990|"~     Circulating anti-beta2-glycoprotein antibodies have been associated with coronary artery~     disease and peripheral arterial disease. This auto-antibodies could activate endothelial~     cells leading to the expression of leukocyte adhesion molecules and increasing the release of~     pro-inflammatory cytokines.~      On the other hand, endothelial dysfunction of atherosclerotic patients acts as a primary~     pathogenic event, as it occur before structural changes are evident on angiogram or~     ultrasound scan. Loss of endothelial normal function causes vasoconstriction, local~     coagulation alterations and an increase arterial wall proliferation. This situation s been~     attributed to a reduction in nitric oxide bioactivity, and to an increase oxygen-free radical~     formation in the context of the pro-inflammatory status found in atherosclerosis.~      Hypothesis: Circulating Anti-beta2-glycoprotein I antibodies could be associated with~     endothelial dysfunction and nitric oxide metabolism disruption en patients with peripheral~     arterial disease.~   "
133264|NCT01822977|"~     The investigators hypothesis is that daily use of a proton pump inhibitor (PPI) is associated~     with significant alterations in the healthy fecal microbiome that are similar to those seen~     in persons with an initial episode of clostridium difficile infection (CDI).~   "
133265|NCT01822964|"~     The aim of this study is to assess the possible neuroprotective effects of cooling (targeted~     cooling of the brain to 33°C) during Transcatheter Aortic Valve Implantation (TAVI)~     procedures. From start of anesthesia, until final valve implantation, local cooling (by the~     RhinoChill device) will be applied to the brain. Effect of cooling on cerebral oxygenation,~     by cerebral oxygen saturation monitoring (NIRS ForeSight technology) during the TAVI~     procedure will be continuously assessed during native valve manipulation and during final~     valve deployment (=primary endpoint of he study). As secondary endpoints, neuropsychological~     testing performed before and after TAVI procedure will assess the effects of the use of~     cooling during the TAVI procedure. Neuron-specific enolase (NSE) and S100-beta will be~     analyzed during and up to 72hrs after TAVI to compare the cerebral ischemic damage between~     cooled and non-cooled patients. And finally, diffusion-weighted MRI of the brain will be~     performed 5 days before and 5-7 days after TAVI to compare the number and total amount of~     cerebral ischemic insults between cooled and non-cooled patients. The hypothesis behind this~     study is that by local cooling of the brain during manipulation of the calcified aorta and~     aortic valve, the brain might be protected from cerebral ischemic insults.~   "
133266|NCT01822951|"~     The objective of this trial is the global risk-benefit assessment of Cerebrolysin as compared~     to donepezil in patients with mild to moderate dementia of Alzheimer's Type (DAT). In~     addition, a traditional approach will be taken based on the evaluation of the separate risk~     and benefit domains in comparison with donepezil.~      Global risk-benefit as compared to donepezil will be analyzed by determining whether the~     Cerebrolysin group shows a statistically significant non-inferiority with regard to the~     combined primary safety and efficacy endpoints (weighted multivariate ensemble). The~     endpoints will be combined by a global multivariate non-parametric procedure, weighting the~     safety and efficacy part 50:50.~   "
133267|NCT01822938|"~     Physical exercise has been identified as a major item of many affecting many chronic diseases~     and stroke rehabilitation. It contributes to an improvement in the quality of life and to a~     decrease in the current treatment side-effects and mortality. Stroke in association with an~     inactive lifestyle lead to a decrease in physical capability and causes problems in daily~     activities. The physical capacity and the tolerance for exercise fall simultaneously leading~     to vicious circle of less and less mobility. Therefore, physical activity for the health is a~     valid and relevant way to improve the quality of life and to recover functional capacity. The~     aim of the study is the assessment of the effects of a incentive program for physical~     activity on people following/with stroke.~   "
133269|NCT01822912|"~     Heart Failure (HF) patients discharged to Skilled Nursing Facilities have higher~     rehospitalization rates and mortality than patients discharged to home.~      HF disease management programs have been shown to reduce rehospitalizations in community~     settings, no national guidelines have been set forth for Skilled Nursing Facilities (SNF).~      This study will investigate the the effect of a heart failure-disease management program on~     the outcome of all-cause hospital readmissions, emergency room admissions and mortality for~     30 days post-SNF admission using 7 component heart failure disease management program.~   "
133270|NCT01822899|"~     This is a multicenter, randomized, double-blind, double-dummy, parallel group study. The~     purpose of this study is to compare the efficacy and safety of umeclidinium/vilanterol~     (UMEC/VI) and fluticasone propionate/salmeterol (FSC) in subjects with Chronic Obstructive~     Pulmonary Disease (COPD). Subjects who meet the eligibility criteria at Screening will~     complete a 7 to 14 day Run-in period. At the end of the run-in period, approximately 710~     eligible subjects will be equally randomized (to complete at least 568 evaluable subjects) to~     one of the 2 treatment groups for 12 weeks: 1. UMEC/VI 62.5/25 micrograms (mcg) administered~     as one inhalation once-daily in the morning via the Novel dry powder inhaler (NDPI) + placebo~     administered as one inhalation each morning and evening via single multidose powdered inhaler~     (ACCUHALER/DISKUS) or 2. FSC 500/50 mcg administered as one inhalation each morning and~     evening via ACCUHALER/DISKUS + placebo administered once-daily in the morning via NDPI. A~     safety Follow-up assessment will be conducted approximately 7 days after the end of the study~     treatment (Early Withdrawal, if applicable). The total duration of subject participation will~     be approximately 15 weeks.~   "
133271|NCT01822886|"~     Pilot clinical trial - Phase 2a, multicenter, single arm, open label trial - to evaluate~     efficacy and safety of concomitant combination treatment with Gemcitabine and Romidepsin~     (GEMRO) regimen as salvage treatment in relapsed/refractory PTCL in a selected population of~     patients.~   "
133272|NCT01822873|"~     The study hypothesis is that patients with dry age-related macular degeneration experience~     visual function impairments such as defects in dark adaptation, glare intolerance, poor light~     transition and reading in low lighting conditions. Studies have shown that patients in the~     early phases of AMD with normal visual acuity commonly reported difficulty with these visual~     functions but there have been no systematic studies evaluating these deficits in this~     population.~      This prospective, exploratory study will include up to 130 patients with dry AMD and 60~     controls. These patients will undergo the following non-invasive visual function testing:~        -  microperimetry with eye tracking~        -  low luminance visual acuity~        -  specialized color vision (cone-specific)~        -  contrast testing and night vision testing.~      High-resolution spectral domain optical coherence tomography (SDOCT) images will be taken of~     the central retina using the Spectralis OCT unit. The values of visual function tested will~     be correlated with the findings on SDOCT (volume/amount of drusen present in early AMD).~      There are no known risks to the subjects beyond what is normal for standard examinations of~     the eye, visual function testing and standard ocular photographic procedures.~   "
133273|NCT01822860|"~     Chlorthalidone will result in improved endothelial function compared to hydrochlorothiazide~     as measured by flow mediated vasodilatation.~   "
133274|NCT01822847|"~     Cortisol is essential for survival. The importance of cortisol response is most apparent in~     patients with partial or complete deficiency of glucocorticoids during stressful events such~     as illness or surgery.~   "
133275|NCT01822834|"~     The Bronchiectasis Research Registry is a consolidated database of non-cystic fibrosis~     (non-CF) Bronchiectasis and Nontuberculosis Mycobacteria (NTM) patients from multiple~     clinical institutions.~   "
133276|NCT01822821|"~     Evaluate the efficacy of IV acetaminophen; compared to a placebo, in reducing opioid~     consumption and/or pain intensity scores after cardiac surgery.~   "
133277|NCT01822808|"~     To investigate the effect of hydralazine isosorbide dinitrate on clinical outcomes, symptoms,~     cardiac parameters and functional status of African patients hospitalized with AHF and left~     ventricular dysfunction during 24 weeks of therapy.~      Administration of hydralazine/nitrates will be superior to placebo administration in reducing~     HF readmission or death, improving dyspnoea, reducing blood pressure and brain natriuretic~     peptide (BNP) in African patients admitted with AHF and left ventricular dysfunction.~   "
133278|NCT01822795|"~     -  BACKGROUND: Medical therapeutic options for the treatment of emphysema remain limited.~          Lung volume reduction surgery is infrequently used because of its high morbi-mortality.~          Endobronchial lung volume reduction coil (LVRC(®), PneumRx, Mountain View, CA) treatment~          has been recently developed and has been shown to be feasible and associated with an~          acceptable safety profile, while resulting in improvements in dyspnea, exercise capacity~          and lung function. The objective of this study is to analyze the cost effectiveness of~          LVRC treatment in severe emphysema.~        -  METHODS:This prospective, multicenter study, randomized with a 1:1 ratio (LVRC vs~          conventional treatment) will include 100 patients who will be followed up for 1year. The~          primary outcome measure is the 6-month improvement of the 6-minute walk test: the~          percentage of patients showing an improvement of at least 54m will be compared between~          groups. A cost-effectiveness study will estimate the cost of LVRC treatment, the global~          cost of this therapeutic option and will compare the cost between patients treated by~          LVRC and by medical treatment alone.~        -  EXPECTED RESULTS:This study should allow validating the clinical efficacy of LVRC in~          severe emphysema. The cost-effectiveness study will assess the medical-economic impact~          of the LVRC therapeutic option.~   "
133279|NCT01822782|"~     The main objective of this study is to assess whether the presence of abnormal vaginal flora~     (intermediate flora or vaginosis) is a risk factor for vaginal lesions at the time of~     delivery. For this, the primary endpoint will be the proportion of vaginal lesions according~     to the presence or absence of abnormal vaginal flora.~      A more precise qualitative and quantitative study of vaginal flora isolated from pregnant~     women and its association with vaginal lesions will also be conducted.~   "
133300|NCT01822509|"~     This phase I/Ib trial studies the side effects and best dose of ipilimumab or nivolumab in~     treating patients with cancers of the blood and blood-forming tissues (hematologic cancers)~     that have returned after a period of improvement (relapsed) after donor stem cell transplant.~     Monoclonal antibodies, such as ipilimumab and nivolumab, may interfere with the ability of~     cancer cells to grow and spread.~   "
133280|NCT01822769|"~     The hypothesis of this study is that participation in a formal cardiopulmonary rehabilitation~     program improves aerobic exercise capacity and quality of life over the medium term for~     patients with congenital heart disease with reduced exercise capacity. To test this~     hypothesis, subjects will be randomized to either receive a 12-week cardiopulmonary~     rehabilitation program or standard of care, with interval testing of aerobic capacity and~     other physiologic markers improved fitness, as well as assessment of quality of life.~   "
133281|NCT01822756|"~     This is a study of ruxolitinib in combination with gemcitabine with or without nab-paclitaxel~     administered to patients with advanced or metastatic pancreatic cancer. The study will be~     conducted in two parts.~      Part 1 of the study will evaluate the safety, tolerability and pharmacokinetics (PK) of~     ruxolitinib when given as described to patients with advanced or metastatic pancreatic~     cancer. A goal of Part 1 will be to identify the maximally tolerated dose (MTD) of~     ruxolitinib when given with gemcitabine with or without nab-paclitaxel. This dose will be~     selected for use in Part 2 of the study.~      Part 2 of the study will further evaluate the safety, tolerability, PK and preliminary~     clinical activity of ruxolitinib at the dose defined in Part 1 used in combination with~     gemcitabine with or without nab-paclitaxel in subjects with advanced or metastatic pancreatic~     cancer.~      After multiple challenges of trial conduct, by mutual agreement between investigators and~     sponsor, dose escalation ended after Cohort B1, RUX 10 mg twice daily (BID) - GCSF in October~     2014. Therefore, the MTD was not reached. No safety issues led to the decision to stop~     further enrollment.~      Because of the early study termination, samples for pharmacokinetics and pharmacodynamics,~     and computed tomography for tumor burden were collected, but not analyzed; analysis data are~     not available. The data cutoff for this posting is 22 SEP 2015. As of the data cutoff, 1~     subject was receiving treatment in the study and had been enrolled for 47 weeks. This subject~     had their end of treatment visit in AUG 2016. A comparison of this subjects' safety data~     after the cutoff date showed no clinically meaningful differences (eg, adverse events)~     compared with safety results that are summarized here.~   "
133282|NCT01822743|"~     The main objective is to evaluate an osteopathic compression of pterygopalatine node in~     healthy subjects and patients suffering from obstructive apnea syndrome (OSA).~   "
133283|NCT01822730|"~     Methamphetamine-associated psychosis (MAP) has been considered a pharmacological or~     environmental pathogen model of schizophrenia (SCZ) due in part to similarities in clinical~     presentation (i.e. paranoia, hallucinations, disorganized speech, and negative symptoms),~     response to treatment (e.g.neuroleptics),and pathologic mechanisms (e.g. central dopaminergic~     neurotransmission) of both conditions. Both paliperidone and risperidone are second~     generation antipsychotics，but have same pharmacological effects of antipsychotic treatment~     and paliperidone may have more efficacy and safty.This study was designed to examine the~     acute efficacy, safety, and tolerability of paliperidone and risperidone for patients with~     MAP.~   "
133284|NCT01822717|"~     The purpose of this study was to find out whether a method of nonvisual foot inspection,~     using the senses of touch and smell, helps people with diabetes and visual impairment to find~     new foot problems when they are in early, easily-treated stages. All people in the study had~     regular foot inspections by podiatrists. The results include how people feel about the~     method, whether they actually did check their feet it, and whether the method helped them to~     discover foot problems themselves.~   "
133285|NCT01822704|"~     This study is a randomized controlled trial aimed to assess the efficacy of a 10-week whole~     body vibration training program on physical functioning, societal participation and quality~     of life in individuals with chronic stroke. It is hypothesized that the whole body vibration~     program will induce significantly more gain in physical functioning, societal participation,~     and quality of life in chronic stroke patients, compared with the control group.~   "
133286|NCT01822691|"~     The primary purpose of this research study is to assess whether the participant's disease,~     Myelodysplastic Syndromes (MDS), responds favorably to INCB024360. The study will also~     evaluate the long-term outcomes of the participant's disease after they have finished taking~     INCB024360.~   "
133287|NCT01822678|"~     Multicentre, double-blind, randomised, parallel-group, placebo-controlled dose-titration~     study; depending on clinical efficacy, up-titration of dosage 3 and 6 days after start of~     treatment; maintenance of individual maximum dose for the rest of the total 3-week treatment~     period; subsequently, down-titration (according to the dose steps and the time intervals of~     up-titration) and administration of an established anti-manic therapy during the tapering-off~     period (in patients who discontinued treatment) or entry into a recurrence prevention study~     (Protocol PRA+SCO/BIA-2093-205; reported under separate cover) as an option for patients who~     responded to the study treatment~   "
133288|NCT01822665|"~     This study evaluated the effect of oral fast-dissolving formulations of paracetamol and~     ibuprofen on the lining of the stomach and duodenum (gastrointestinal mucosa). Endoscopic~     examinations were conducted to determine the gastrointestinal damage produced post a 7 day~     treatment regimen.~   "
133289|NCT01822652|"~     Subjects that have relapsed or refractory neuroblastoma are invited to take part in this gene~     transfer research study.~      We have found from previous research that we can put a new gene called a chimeric antigen~     receptor (CAR) into T cells that will make them recognize neuroblastoma cells and kill them.~     In a previous clinical trial, we used a CAR that recognizes GD2, a protein found on almost~     all neuroblastoma cells (GD2-CAR). We put this gene into T cells and gave them back to~     patients that had neuroblastoma. The infusions were safe and in patients with disease at the~     time of their infusion, the time to progression was longer if we could find GD2 T cells in~     their blood for more than 6 weeks. Because of this, we think that if T cells are able to last~     longer, they may have a better chance of killing neuroblastoma tumor cells.~      Therefore, in this study we will add new genes to the GD2 T cells that can cause the cells to~     live longer. These new genes are called CD28 and OX40. The purpose of this study will be to~     determine the highest dose of iC9-GD2-CD28-OX40 (iC9-GD2) T cells that can safely be given to~     patients with relapsed/refractory neuroblastoma.~      In other clinical studies using T cells, some investigators found that giving chemotherapy~     before the T cell infusion can improve the amount of time the T cells stay in the body and~     therefore the effect the T cells can have. This is called lymphodepletion and we think that~     it will allow the T cells we infuse to expand and stay longer in the body, and potentially~     kill cancer cells more effectively.~      The chemotherapy we will use for lymphodepletion is a combination of cyclophosphamide and~     fludarabine.~      Additionally, to effectively kill the tumor cells, it is important that the T cells are able~     to survive and expand in the tumor. Recent studies have shown that solid tumors release a~     substance (PD1) that can inhibit T cells after they arrive into the tumor tissue. In an~     attempt to overcome the effect of PD1 in neuroblastoma we will also give a medication called~     pembrolizumab.~   "
133345|NCT01821924|"~     The investigators plan to use retrospective data to assess heart function and structure~     abnormalities through the use of an approved vasodilating agent for stress cardiac MRI tests.~     The investigators are interested in how these MRI findings relate to long-term prognosis in~     people who are at risk for cardiac disease.~   "
133290|NCT01822639|"~     The study is designed to estimate the bioavailability of amlodipine and enalapril maleate~     fixed dose combination (FDC) relative to co-administration of amlodipine and enalapril~     maleate tablets. The rational for this study is to provide a more convenient dosing regimen~     for patients. This is an open-label, randomized, single dose, two-way crossover study, in~     which 16 healthy adult male and female subjects will be enrolled and dosed under fasting~     conditions. Each subject will participate in two treatment periods of 7 days each. There will~     be at least 14 days of wash out period between the two dosing periods and a follow-up period~     of up to 21 days after treatment period 2. The total duration of study will be approximately~     35 days from the start of the first treatment.~   "
133291|NCT01822626|"~     Obesity is one of the leading causes of morbidity and mortality in the industrialised world.~     Evidence is growing that early life nutrition can play a role in behavioural and cognitive~     problems in children and adolescents and is well documented that being overweight and obese~     during childhood can have short- and long-term physical and psycho-social health~     implications.~      This is an individually randomised trial to evaluate the efficacy of a family~     pediatrician-lead counselling intervention in reducing the BMI of over-weight children aged~     4-7 years old. As secondary objectives the investigators evaluate the effect of the~     counselling on dietary behaviours and physical activity.~      The investigators targeted the intervention to overweight children, while obese children were~     referred to specialised care. The counselling targeted diet, physical activity, and sedentary~     behaviours.~   "
133292|NCT01822613|"~     To study the safety and efficacy of the combination of LJM716 and BYL719 against currently~     available treatments of physician's choice in previously treated esophageal squamous cell~     carcinoma patients.~   "
133293|NCT01822600|"~     To test whether intravenous albumin can decrease the rebleeding rate or shorten the duration~     of hospitalization in patients with peptic ulcer bleeding and hypoalbuminemia.~   "
133294|NCT01822587|"~     The investigators' recently completed study has provided the first evidence that~     administration of the medication propranolol, following exposure to cocaine cues, can alter~     drug-associated memories and reduce craving and other drug cue-elicited responses in cocaine~     addicted persons. The investigators will attempt to augment this effect by a) doubling the~     number of propranolol-medicated cocaine cue exposure (CCE) retrieval sessions and b)~     increasing the dose of propranolol. It is expected that propranolol treated groups, relative~     to placebo treated groups, will evidence greater reduction of craving, cue reactivity and~     cocaine use during follow-up cocaine cue exposures. Also, these effects will be greater for~     those who receive 80mg of propranolol as opposed to 40mg.~   "
133295|NCT01822574|"~     This research was performed to determine which of the three techniques used by knee surgeons~     at the Mayo Clinic was the most accurate at the surgical removal (resection) of the knee-cap~     (patella) in a symmetric fashion during total knee replacement (arthroplasty). Although all~     three techniques are known to be effective, the three techniques had never been compared to~     one another to determine if one was more effective than the others at resecting the patella.~   "
133296|NCT01822561|"~     -  The goal of the study is to examine the short-term effects and safety of a systemic~          anti-aldosterone medication, eplerenone, in a small group of patients with central~          serous chorioretinopathy (CSCR).~        -  There is currently no standard treatment or therapy for either acute or chronic CSCR, a~          potentially debilitating eye disease.~        -  There is evidence in both animals and humans that high blood serum corticosteroid levels~          can cause or worsen CSCR or findings similar to CSCR in the choroid and retina~        -  Eplerenone, a mineralocorticoid receptor antagonist, has been shown to be of visual and~          anatomic benefit in a small series of 4 patients with chronic CSCR, suggesting that~          decreasing mineralocorticoid action in the eye may improve signs and symptoms of CSCR~        -  The investigators' aim is to evaluate a standardized dose of eplerenone in a controlled~          prospective fashion for both acute and chronic CSCR.~        -  The study consists of taking a standard dose of eplerenone, 50mg once daily, for 1 month~        -  Over the course of the month, patients will be monitored for side effects, as well as~          visual and anatomical response to the medication~   "
133297|NCT01822548|"~     The purpose of this study is to evaluate the effect of Dipeptidyl peptidase (DPP) -IV~     inhibitor Vildagliptin vs. Glibenclamide on circulating endothelial progenitor cells (EPCs)~     number in type 2 diabetes patients in metformin failure. Subjects will be followed for 12~     months after randomization.~   "
133298|NCT01822535|"~     The ability to maintain normal body core temperature (Tcore = 98.6°F) is impaired in persons~     with tetraplegia. Despite the known challenges to the ability of persons with spinal cord~     injury (SCI) to maintain Tcore, and the effects of hypothermia to impair mental function in~     able-bodied (AB) persons, there has been no work to date addressing these issues in persons~     with tetraplegia.~      The aim of this study is to determine if exposure of up to 2 hrs to cool temperatures (64°F)~     causes body core temperature to decrease in persons with tetraplegia and if that decrease is~     related to a decrease in mental performance.~      After sitting in a cool (64°F) room for up to 2 hours the investigators hypotheses are:~      Hypotheses (1): Tcore of most of the persons with tetraplegia will decline approximately~     1.8°F (e.g., 98.6 to 96.8°F) while Tcore of controls will not decline at all; (2) Most of the~     persons with tetraplegia will show a decline in mental performance (memory or~     clear-headedness) while only some of AB controls will show a decline.~      The second aim of this study is to determine if a 10 mg dose of an approved blood pressure~     raising medicine (midodrine hydrochloride) will (1) reduce the decrease in body core~     temperature and (2) prevent or delay the decline in mental performance in the group with~     tetraplegia compared to the exact same procedures performed on the day with no medicine~     (Visit 1) in the same group.~      Hypotheses (3 & 4): The changes in blood flow to the skin caused by taking a one-time dose of~     midodrine will lessen the decline in Tcore and prevent or delay the decline in mental~     performance compared to the changes in Tcore and mental performance during cool temperature~     exposure without midodrine in the group with tetraplegia.~   "
133299|NCT01822522|"~     This phase I trial studies the side effects and best dose of cabozantinib-s-malate in~     treating patients with solid tumors that have spread to other places in the body and usually~     cannot be cured or controlled with treatment and human immunodeficiency virus.~     Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth.~   "
133301|NCT01822496|"~     This randomized phase II trial studies how well erlotinib hydrochloride or crizotinib with~     chemoradiation therapy works in treating patients with stage III non-small cell lung cancer.~     Radiation therapy uses high energy x rays to kill tumor cells. Specialized radiation therapy~     that delivers a high dose of radiation directly to the tumor may kill more tumor cells and~     cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin, etoposide,~     paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either~     by killing the cells, by stopping them from dividing, or by stopping them from spreading. It~     is not yet known whether giving erlotinib hydrochloride is more effective than crizotinib~     with chemoradiation therapy in treating patients with non-small cell lung cancer.~   "
133302|NCT01822483|"~     The purpose of this study is investigate mycophenolic acid exposure through area under the~     curve in renal transplants recipients treated with mycophenolate mofetil and after conversion~     to mycophenolate sodium.~   "
133303|NCT01822470|"~     The purpose of this study is to investigate the prevalence of small intestinal bacterial~     overgrowth (SIBO) in patients who will be undergoing an enteroscopy as an outpatient~     procedure with symptoms of functional dyspepsia. In addition, the investigators would like to~     identify the types of bacteria that are present in the small intestines in patients with SIBO~     and compare two different diagnostic tools: microbiologic culture and DNA sequencing of~     bacteria.~      The aim is to compare the microbiota between patients with and without the clinical~     complications of SIBO~   "
133304|NCT01822457|"~     This is a randomised controlled study of patients suffering from intermittent claudication~     (IC), to assess the impact of wearing a Nike FuelBand (NFB) on walking distances, exercise~     levels and quality of life.~      IC manifests as pain in the calf, thigh or buttock muscles when walking. It is caused by~     narrowing or blockage of the blood vessels in the legs.~      The NFB is a discrete wristband with a built-in accelerometer to measure motion. It provides~     estimates of the number of steps taken and the amount of distance covered each day.~      This study will be conducted over a period of 18 months at Imperial College Trust's vascular~     outpatients service. Patients that meet the inclusion/exclusion criteria will be asked to~     consider participating. Participants will receive routine diagnostic work up with the~     addition of having their walking distances measured on a lab treadmill. They will also have~     their functional status and mood assessed using a questionnaire. These assessments will be~     carried out a total of five times over the course of the study. Patients will not need to~     make any additional visits to hospital.~      Patients will be randomly allocated to either the NFB group or the control group. Patients in~     the NFB group will be given a FuelBand with instructions on how to use it. All patients will~     be given routine instructions on maintaining activity and target daily walking distances.~     Target walking distances will be programmed into the NFB. Patients in the NFB group will be~     asked to record estimates of how far they have walked each day directly from their band. All~     patients will be contacted by telephone at a pre-arranged time to collect recordings.~      Patients will be followed up at their routine 3-month follow up appointment and additionally~     at 6 and 12 months.~   "
133305|NCT01822444|"~     Primary Objective:~      The primary objective is to validate previously identified predictive/prognostic genomic DNA~     and expression biomarkers of response to combination bvz treatments in K-ras mutant advanced~     CRC (a CRC) or metastatic CRC (mCRC).~      Secondary Objective:~        1. To test the efficacy of bvz in combination with FOLFOX in patients with newly diagnosed~          advanced or metastatic K-ras mutant CRC and~        2. To determine the progression free and overall survival of patients under first line~          FOLFOX + bvz in aCRC or mCRC.~   "
133306|NCT01822431|"~     This study will examine if one of the following methods: pupillometry, spectral analysis of~     heart rate variability and metaiodobenzylguanidine scintigraphy, is more capable to detect~     early diabetic autonomic neuropathy in patients with type 1 diabetes mellitus~   "
133307|NCT01822418|"~     Major depressive episodes (MDEs) occur frequently during the course of psychotic disorders,~     and several antidepressive agents have been successfully applied. The new melatonergic~     antidepressant agomelatine (AGO) appears promising for the treatment of MDEs in schizophrenia~     for several reasons. The investigators plan to test the efficacy and tolerability of AGO for~     antidepressive treatment in schizophrenia. For this task, the investigators plan to enrol 27~     schizophrenic patients into an open, single-armed, prospective clinical trial with~     agomelatine.~   "
133308|NCT01822405|"~     The pentoxifylline used with tocopherol achieves a certain effectiveness in the treatment of~     the fibrosis.~      Hyperbaric oxygen therapy has been recommended and used in a wide variety of medical~     conditions including the treatment of delayed radiation injuries (soft tissue and bony~     radiation necrosis). The hyperbaric oxygen therapy increases the formation of granulation~     tissue and produces angiogenesis maintained after use.~   "
133309|NCT01822392|"~     The research evaluates the use of online versions of delivering an effective psychological~     treatment for children clinically referred for serious oppositional, aggressive, and~     antisocial behavior. The goal is to develop models of delivery that reach families in need~     that are not being served by in-person treatment. The project has immediate implications for~     the treatment of children but more generally addresses several issues critical to treatments~     that are based on Internet, telepsychiatry, and related technologies.~   "
133310|NCT01822379|"~     Previous studies have evaluated the transplantation of pigment cells (melanocytes)and skin~     cells (keratinocytes) for the treatment of vitiligo. This procedure is known as MKTP~     (Melanocyte Keratinocyte Transplantation Procedure). Multiple studies have found this~     procedure to be both safe and effective for the treatment of vitiligo. The majority of these~     studies utilized trypsin to help isolate melanocytes and keratinocytes. Trypsin is enzyme~     that helps to separate the different layers of skin. However, some cell biologists believe~     that the enzyme dispase (which can be used to separate the epidermis from the dermis) is less~     toxic to cells of the epidermis and can result in a greater number of viable melanocytes and~     keratinocytes for transplantation.~      This study will look at the repigmentation rates of MKTP using trypsin to isolate cells,~     versus MKTP using dispase to isolate cells.~   "
133346|NCT01821911|"~     The objective of this study was to achieve the post-marketing safety and immunogenicity~     research of Speeda® rabies vaccine for human use from Chengda Bio~   "
143952|NCT01683110|"~     The objective of this study is to provide access to cabozantinib for eligible subjects with~     medullary thyroid cancer (MTC) pending approval of Exelixis' New Drug Application (NDA) by~     the FDA and commercial availability of cabozantinib.~   "
133311|NCT01822366|"~     The primary goal is to study the effectiveness of Trauma-focused Cognitive Behavioral Therapy~     (TF-CBT) in treating traumatic grief and traumatic stress for orphaned children and young~     adolescents in two East African sites with high prevalence HIV, Moshi, Tanzania (TZ) and~     Bungoma, Kenya (KE), through a randomized controlled trial (RCT). In a previous feasibility~     study of TF-CBT with orphans in Tanzania, the investigators have found a group-based TF-CBT~     intervention to be feasible and acceptable, with promising clinical outcomes. In the~     feasibility study, lay counselors with no prior mental health experience delivered the~     intervention with training and supervision by our team of mental health and TF-CBT experts.~      Building on this initial study, the investigators are conducting a RCT to test the~     effectiveness of TF-CBT for traumatic grief and traumatic stress compared to receipt of usual~     care orphan services in TZ and KE. The study involves collaboration with HIV/AIDS grassroots~     organizations and local Co-Investigators in TZ and KE, both of whom are longstanding~     collaborators with the investigators' US team and are located in mixed urban and rural areas,~     allowing examination of effectiveness in two countries and two settings (urban/rural). Using~     a task-shifting approach, in which lay individuals are trained as counselors, the~     investigators will train six counselors in each country, who deliver 20 groups in each site~     (10 rural, 10 urban), resulting in 320 children and adolescents (ages 7-13) who receive~     TF-CBT and 320 who receive usual care. Outcomes for children are assessed at 12-14 weeks~     (i.e., corresponding with the end of TF-CBT), 6-months post-treatment, and 12-months~     post-treatment. TF-CBT experts from the investigators' team partner with the lay counselors~     from the feasibility study (e.g., local trainers) to train the TZ and KE counselors, and~     these local trainers provide the TF-CBT supervision, while supervised themselves by the~     US-based TF-CBT and mental health experts. The investigators expect this trial to yield~     recommendations regarding an effective intervention for orphans that is acceptable, feasible,~     and includes local responsibility as a means to enhance potential sustainability in Low- and~     Middle-Income Countries (LAMICs). Findings will inform other efforts to scale up mental~     health interventions to address the substantial mental health gap.~   "
133312|NCT01822353|"~     In Finland, the estimated prevalence of physician-diagnosed food allergy in 1-4 year old~     children is 9%, and the most common allergen is milk. The overall food allergy has been~     reported to be 3.7%. Hen's egg allergy is among the most common food allergies in childhood.~     In addition, it predicts later development of allergic disease such as asthma. Most of the~     egg and milk allergy is transient and disappears in childhood. Currently, the standard of~     care for food allergy includes strict allergen avoidance. However, oral immunotherapy has~     been under investigation in children milk, egg, and wheat allergy. Previously, induction of~     clinical egg tolerance has been reported with egg oral immunotherapy in children aged from 3~     to 13 years. In adults, strict avoidance is still the standard care but there is also growing~     interest in treatment of severe food allergy with oral immunotherapy or anti-IgE.~      The investigators aim to analyse the results of per oral immunotherapy treatment in severe~     IgE-mediated egg, milk, and nut allergy in adults.~      Could severe egg, milk and nut allergy be treated with oral immunotherapy treatment in stead~     of total allergen avoidance and could desensitization thus be achieved?~   "
133313|NCT01822340|"~     The purpose of this study is to assess the safety, tolerability and Pharmacokinetic/~     Pharmacodynamic (PK/PD) profile of three doses of HM10560A on an every week (EW) regime and~     one dose on every other week (EOW) regime administered for a period of 24 weeks initial~     study.~   "
133314|NCT01822327|"~     This study is designed to advance our development of a treatment for cocaine dependence. The~     investigators hypothesize that clients with high-risk characteristics will benefit from~     enhanced levels of treatment.~   "
133315|NCT01822314|"~     The purpose of this study is to assess the efficacy of neoadjuvant weekly nab-paclitaxel~     followed by Adriamycin, Cyclophosphamide (AC) or Epirubicin, Cyclophosphamide (EC) or~     Fluorouracil,Epirubicin,Cyclophosphamide (FEC)compared with neoadjuvant weekly solvent-based~     paclitaxel followed by AC or EC or FEC in terms of rate of pathological complete remissions~     at surgery.~   "
133316|NCT01822301|"~     Fat grafting represents a technique with great potential to improve outcomes in minimally~     invasive facial reconstruction. Fat grafting has already been demonstrated as a safe and~     minimally invasive technique over decades of widespread practice in plastic surgery. In our~     current study of fat grafting for facial deformities (IRB# PRO09060101), we have treated 9~     subjects without adverse event and all have had a significant improvement. Since all methods~     of treatment and evaluation are the same in this study, we will be able to use the data in~     our prior study as additional control data.~      We hypothesize that repeating the fat grafting in subjects with previous facial fat grafts~     will enable successful restoration of tissue volume and craniofacial form. Additionally, we~     hypothesize that the results will be durable and subject quality of life improved.~      Five (5) subjects (who were previously enrolled into IRB# PRO09060101) will be enrolled to~     this single center University of Pittsburgh site research study.~   "
133317|NCT01822288|"~     Menopausal syndromes includes somatic symptom, psychosomatic symptoms, sexual dysfunction and~     even urinary symptoms. Hormone therapy (HT) is widely used for controlling menopausal~     symptoms. Common HT for menopausal syndrome with intact uterus includes tibolone, estradiol~     valerate (E2V) 1mg & medroxyprogesterone acetate (MPA) 2.5 mg, and conjugated equine~     estrogens & MPA.~      However, only a few literatures mentioned about the therapeutic effect of tibolone, but lack~     of comparison research about their therapeutic effect on somatic symptoms, psychosomatic~     symptoms, sexual dysfunction and even urinary symptoms. The knowledge of the above~     therapeutic effects should be important for choosing a suitable medication. Therefore, the~     aim of this study is to assess the therapeutic effect on somatic symptoms, psychosomatic~     symptoms, sexual dysfunction and even urinary symptoms between tibolone and E2V/MPA.~   "
133318|NCT01822275|"~     In the current proposed trial the role of the low-dose WBRT (0.15 Gy) would be to safely~     treat the microscopic distant GBM cells outside of the high dose RT region and sensitize the~     gross tumor, while the focal radiation dose (1.85 Gy) to the gross tumor will bring the total~     tumor dose of 2 Gy per fraction which is the standard of care.~      Radiotherapy (RT) has been integral in the treatment of GBM since the 1970s when Walker et~     al. showed that post-operative whole brain radiotherapy (WBRT) offered significant~     improvements in median survival time, and even more so when given with concomitant BCNU~     chemotherapy. Ensuing dose escalation studies found the optimal dose to be 60 Gy. Patients~     could not tolerate escalation to higher doses than 60 Gy with WBRT due to unacceptable~     toxicity. Even with WBRT of 60 Gy, a huge volume of healthy brain tissue was unnecessarily~     treated with high-dose radiation; recurrences with WBRT remained overwhelmingly local.~     Hochberg and Pruitt (1980) found that after WBRT only 3% of recurrences were outside 2 cm of~     the margins of the primary tumor. With the rise of the CT scan in the 1980s and the MRI in~     the 1990s, along with subsequent improvements in three-dimensional conformal radiation,~     partial brain RT (PBRT) became practical since tumor margins could be visualized and~     irradiated more accurately. - Subsequently, WBRT was shown to provide no survival benefit~     over PBRT at the same dosage; - thus, the latter took over as the standard of care.~   "
133319|NCT01822262|"~     To explore the therapeutic effects for treatment of cholecystolithiasis by minimally invasive~     cholecystolithotomy with gallbladder reservation and laparoscopic cholecystectomy. Method：~     patients with cholecystolithiasis who received minimally invasive Cholecystolithotomy with~     gallbladder reservation and patients with cholecystolithiasis who received laparoscopic~     cholecystectomy(LC) in The Affiliated Hospital of Guiyang Medical College from May 2011 to~     December 2013. Patients who received minimally invasive cholecystolithotomy with gallbladder~     reservation as trial group, patients who received LC as control group.the overall follow-up~     period is 1 year. Then the investigators statistically analyze improvement of~     cholecystolithiasis symptoms in every group, thickness of gall bladder wall, the gallbladder~     function and the rate of the recurrence of cholesterol gallstone in trial group.~   "
133320|NCT01822249|"~     Rett syndrome is a severe neurodevelopmental disorder that primarily affects female children.~     Rett syndrome is characterized by significant elevation in blood markers of oxidative stress.~     EPI-743 is a novel therapeutic with demonstrated efficacy and safety in the treatment of~     disorders characterized by oxidative stress. The purpose of this study is to examine the~     safety and efficacy of EPI-743 in a population of children with Rett syndrome.~   "
133321|NCT01822236|"~     The purpose of this study is to determine whether a craniosacral therapy program are~     effective on disability, quality of life, autonomic nervous system and oxidative stress~     indicators in patients with chronic low back pain.~   "
133322|NCT01822223|"~     The purpose of this study is to determine which implant-abutment design is more likely to~     promote early soft-tissue healing processes and/or will enhance longitudinal peri-implant~     bone and soft-tissue health.~   "
133323|NCT01822210|"~     Preclinical studies at our institution, using a genetic mouse model of gastric cancer,~     strongly suggest that innervation of the stomach wall is required not only for the~     development, but also for the progression of gastric cancer, and that denervation of the~     stomach either by vagotomy or by injection of botulinum toxin (Botox®) in the stomach wall~     may represent an effective therapeutic intervention. New treatment options for inoperable~     cancer in the stomach are urgently needed, and local treatment with botulinum toxin seems to~     be an attractive possibility. In this pilot study Botox injections will be given by~     gastroscopy in both the tumor and the surrounding stomach wall. The purpose of the study is~     to obtain data needed to calculate sample size in a larger controlled trial.~   "
133324|NCT01822197|"~     The purpose of this study is to determine whether bright light phototherapy can improve~     depressive symptoms in hospitalized patients with cystic fibrosis (CF) with subsequent~     effects on quality of life and illness recovery. It is hypothesized that phototherapy will~     improve depressive symptoms and decrease length of stay in depressed patients with CF who are~     hospitalized.~   "
133325|NCT01822184|"~     Hunter syndrome (Mucopolysaccharidosis II, [MPS II]) is a rare, genetically linked lysosomal~     storage disease (LSD) caused by deficiency of the enzyme, iduronate-2-sulfatase (I2S). Most~     MPS II patients will present with some degree of neurodevelopmental involvement, ranging from~     severe cognitive impairment and behavioral problems to mildly impaired cognition. This is an~     observational study; no investigational treatment will be administered. The primary objective~     of this study is to evaluate the neurodevelopmental status of pediatric patients with MPS II~     over time and to gain information to guide future treatment studies in this patient~     population.~   "
133326|NCT01822171|"~     Readmission to a hospital shortly after discharge is a common and costly problem. In the~     United States patients with a diagnosis of heart failure currently experience an elevated 30~     day readmission rate of approximately 20%. By providing patients with medication related~     counseling at discharge by a pharmacist, home medications at discharge, and seeing the~     patient again in a pharmacist-run Medication Therapy Management (MTM) clinic 7 days after~     discharge, the study anticipates achieving its primary goal of showing a reduction in the~     readmission rate. Secondary goals are: 1) to determine patients understanding of the~     medication they are taking, 2) to evaluate satisfaction with the comprehensive discharge~     counseling service, and 3) determine the number of interventions made and benefit of the MTM~     clinic.~   "
133327|NCT01822158|"~     This study is to determine if using a standardized debrief checklist after vaginal delivery~     improves communication between the vaginal delivery health care team members and if using the~     checklist increases a sense of enhanced communication between team members.~   "
133328|NCT01822145|"~     The primary hypothesis is that an ICD shock may be predicted days in advance by a combined~     score derived from different data obtainable from the ICD~   "
133329|NCT01822132|"~     The purpose of this protocol is to learn more about impulsive decision making in people who~     use methamphetamines. The investigators would like to know if a medication called naltrexone~     changes how people make decisions. The investigators would also like to know whether changes~     in decision making can be observed by MRI (magnetic resonance imaging).~      The research is conducted in Portland, OR.~   "
133330|NCT01822119|"~     The rationale behind this clinical performance investigation is to collect data regarding the~     usability of the Baha Attract System in patients with hearing impairment that are candidates~     for Baha surgery:~        -  To describe the expected hearing performance with the Baha Attract in comparison to~          unaided hearing thresholds or a pre-test situation using a sound processor together with~          a softband~        -  Which sound processor to select, i.e. BP100 vs BP110~        -  Improve the fitting process for the sound processor~        -  Selection of sound processor magnet at time of fitting and over time~   "
133347|NCT01821898|"~     Eosinophilic Esophagitis (EoE) is a disorder in which a type of white blood cell (eosinophil)~     involved in allergic reactions, enter and cover the walls of the esophagus (food pipe). As a~     result, the esophagus becomes swollen and blocked making it difficult to swallow, and this~     leads to heartburn. In severe cases it can lead to food getting stuck in the esophagus and~     poor growth or weight loss in children~      The main purpose of this research study is to compare the effectiveness of two different~     types of treatment for EoE:~        1. Oral viscous budesonide- which is a steroid medication that has been used to treat~          asthma. Recently, it has been used as a therapy to treat the eosinophilic inflammation~          in EoE, and~        2. Specific food elimination.~      The study will also be looking to see if a blood test is useful in following the progression~     of EoE. Currently the only way to follow EoE is by repeating endoscopy, which is a more~     invasive test.~   "
133331|NCT01822106|"~     GERD is due to gastric content reflux to esophagus cause symptom and complication including~     intra-esophagus such as reflux esophagitis, and extra-esophagus such as cough etc. Because~     the changes of dietary habit, and improvement of examination skill and data analysis, the~     prevalence of GERD increased 2.5 multiple from 1995 to 2002, and suggesting the prevalence is~     25% in Taiwan community.~      Although proton pump inhibitor (PPI) can inhibit gastric acid secretion, relief symptom and~     enhancing repair of esophageal damage, therefore, PPI is a main drug for the treatment of~     GRED, but because of PPI has disadvantage of poor compliance, and slow gastric empty time and~     hypersensitivity, and about 40-50% of GERD patients is inefficacy. In addition, PPI produces~     bone fracture, community pneumonia and diarrhea in patient with long-term use.~      Wu-Chu-Yu tang consists of Evodia fargesii Dode (Evodia Fruit), Panax ginseng C. (Ginseng),~     Ziziphus jujube Mill (Chinses Date), Zingiber officinale Rosee (Fresh Ginger). According to~     I-Fang-Chi-Chieh and Shanghonzobinglun recordings that Wu-Chu-Yu tang can treat vomiting,~     and also can relax gastric tonicity and can enhance peristalsis of stomach.~      Therefore, the purpose of the present study was to investigate the efficacy of Wu-Chu-Yu tang~     on GRED, and this effect of Wu-Chu-Yu tang compared to PPI Omeprazole.~   "
133332|NCT01822093|"~     Human Adenovirus-specific T-cells can persist and augment impaired adenovirus immune response~     post allogeneic haematopoietic stem cell transplant, and reduce the requirement for antiviral~     therapy without toxicity or increasing the occurrence of Graft Versus Host Disease. This is a~     Phase I/IIa open-label safety study, assessing the effects of administering~     adenovirus-specific T-cells (Cytovir ADV) to paediatric patients post haematopoietic stem~     cell transplant.~   "
133333|NCT01822080|"~     This study is aimed to evaluate efficacy and safety of dienogest 2 mg oral tablets in the~     treatment of endometriosis.~      There will be 2 study phases: a double-blind, randomized, placebo-controlled, parallel-group~     phase over 24 weeks, and an open-label extension phase with 2 mg DNG daily p.o. over 28 weeks~     for all subjects who completed the double-blind phase, irrespective of their treatment~     assignment in the first study phase.~   "
133334|NCT01822067|"~     The specific aim of this study is to use MRI methods to evaluate and compare brain structure~     and function in two groups of full-term neonates at two-weeks of age: those born of obese~     mothers and those born to normal weight mothers.~   "
133335|NCT01822054|"~     The specific aim of this research project is to use MRI methods to evaluate and compare brain~     structure and function in normal weight and obese children age 8-10 years.~   "
133336|NCT01822041|"~     This is study in healthy human volunteers to determine the absorption, metabolism, and~     excretion (AME) profile of ARN-509 as well as its absolute oral bioavailability (BA).~   "
133337|NCT01822028|"~     Cross-over, tolerability study with healthy subjects taking Zavesca in combination with~     Florastor. Forty-two subjects will be randomized to one of two treatment sequences of Zavesca~     with Florastor and Zavesca with Placebo of Florastor. Gastrointestinal tolerability and PK~     endpoints, demographic, laboratory and safety testing, and AEs and SAEs will be collected~     throughout the seventy-four day study.~   "
133338|NCT01822015|"~     This pilot clinical trial studies sirolimus, idarubicin, and cytarabine in treating patients~     with newly diagnosed acute myeloid leukemia. Sirolimus may stop the growth of cancer cells by~     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as~     idarubicin and cytarabine, work in different ways to stop the growth of cancer cells, either~     by killing the cells or by stopping them from dividing. Giving sirolimus together with~     idarubicin and cytarabine may kill more cancer cells.~   "
133339|NCT01822002|"~     To determine the immediate therapeutic efficacies of canalith repositioning maneuvers in each~     type of BPPV (posterior canal type, apogeotropic horizontal canal type and geotropic~     horizontal canal type).~   "
133340|NCT01821989|"~     Hypothesis:~      Orally ingested lactoferrin has effects on promotion of growth and differentiation of the~     immature gut; also it has immunomodulatory properties, so it will prevent serious infections~     in preterm infants.~      The aim of the study is to:~        -  Evaluate the effectiveness of oral lactoferrin in prevention of neonatal sepsis.~        -  Compare two dose regiment of lactoferrin supplementation.~        -  Study effect of lactoferrin supplementation on serum iron stores.~      It is a prospective, randomized, double blind, placebo-controlled study, it will include 180~     preterm neonates admitted to the Neonatal Intensive Care Units of of Ain Shams University~     Hospitals and Manshiet El Bakry Hospital.~      •Group A: Who will receive oral lactoferrin supplementation in a dose of 100 mg/day.~      •Group B: Who will receive oral lactoferrin supplementation in a dose of 150 mg/kg/ twice~     daily.~      •Group C (Controls): Who match the subjected neonates, will receive placebo in form of~     distilled water.~   "
133341|NCT01821976|"~     The goals of the TAOS study is to determine the best procedures for below the knee~     amputations. There are two different procedures currently used by surgeons around the county:~     the Erlt procedure and the Burgess procedure. Proponents of the Ertl procedure advocate that~     the surgical formation of a tibia to fibula bone bridge provides stability, shape and weight~     bearing capability to the residual limb that result in less pain and better prosthetic fit~     and alignment. This procedure is popular especially among the military but it's advantages~     over the Burgess procedure are not well supported by current research. This study aims to~     compare the two amputation procedures in an adequately powered randomized trial.~   "
133342|NCT01821963|"~     The goal of this clinical research study is to learn if the antiviral combination of~     telaprevir, pegylated Interferon Alfa 2a (PegIFN alfa-2a) and ribavirin (RBV) can prevent the~     virus from coming back after the liver transplant.~      Telaprevir, PegIFN alfa-2a, and RBV are different antiviral drugs that work in combination at~     different stages of the HCV infection to stop the virus.~   "
133343|NCT01821950|"~     This study will evaluate the efficacy of yoga taught during school to positively influence~     risk and protective factors of substance use and the initiation and severity of substance~     use. The study hypothesis is that, compared to a control group participating in regular~     physical education classes, subjects who participate in 32 yoga sessions across an academic~     year will improve in negative internalizing behaviors and self-regulatory skills that are~     known risk and protective factors for substance use. This study will also test the hypothesis~     that the yoga intervention will reduce both severity of substance use and the degree of~     substance use initiation.~   "
133344|NCT01821937|"~     The aim of the trial is to assess the bioavailability of Faldaprevir soft capsule with single~     oral dose and multiple oral doses in Chinese subjects~   "
133349|NCT01821872|"~     Despite its use for decades all over the world, the exact mechanism of action of paracetamol~     is not fully understood and essentially involves a combination of hypotheses. It is known to~     have an effect via the central nervous system, and of the many mechanisms proposed, one~     hypothesis is that it may have indirectly activate CB1 (cannabinoid) receptors, through its~     novel metabolite AM404.~      This study aims to elucidate cerebrospinal levels of paracetamol and to measure the~     concentration of its metabolites, including AM404 in CSF. This may, in turn, give us useful~     information on the mechanism of action of paracetamol.~   "
133350|NCT01821859|"~     The protocol will study the effect of the combination of two drugs—Abraxane and~     Bevacizumab—on a subject's ovarian cancer, fallopian tube cancer, or primary peritoneal~     cancer. This study drug combination will be given to subjects who have already been treated~     for their cancer with other chemotherapy, and now their cancer has become worse or has come~     back again. Neither one of these study drugs has been approved by the FDA for treatment in~     these three types of cancer.~   "
133351|NCT01821846|"~     This trial is conducted in Asia. The aim of this study is to investigate the safety profile~     of liraglutide (Victoza®) under normal conditions of use in Korean subjects with type 2~     diabetes mellitus.~   "
133352|NCT01821833|"~     Paclitaxel, a widely used chemotherapeutic agent, is associated with several well-known side~     effects including neuropathy (weakness, numbness and pain) and generalized body aches. The~     latter has recently been described as paclitaxel-associated acute pain syndrome (P-APS) and~     often occurs in the first three to four days after administration. It affects about 58-90% of~     patients. Currently, the mechanism of P-APS is unknown, and there is no standard of care to~     treat it. However, an intervention with both anti-inflammatory as well as neuroprotective~     properties would be an ideal candidate for testing in the prevention of P-APS and subsequent~     development of peripheral neuropathy. Previous studies have suggested that omega-3 fatty~     acids may act as neuroprotective agents, and there are no currently documented safety~     concerns with their combined use with paclitaxel.~      Therefore, this randomized pilot clinical trial will determine whether omega-3 fatty acids~     can treat pain in patients with breast or ovarian cancer receiving paclitaxel.~   "
133353|NCT01821820|"~     Ingestion of 3 ounces of pistachio nuts per day for two weeks before and the day of cycling~     intensely for 75 kilometers will support substrate utilization during exercise (as determined~     through metabolomics) and improve performance compared to water only, and attenuate~     inflammation, oxidative stress, and immune dysfunction during 24 hours of recovery.~   "
133354|NCT01821807|"~     The aim of the study is to observe the rate of postdural puncture headache observed after~     spinal anesthesia in cesarean section patients.~      Two kind of spinal anesthesia needles will be used:~        1. 26 Gauge Quincke (cutting-tip needle)~        2. 26 Gauge Atraucan (atraumatic needle)~      The investigators will observe:~        1. Number of spinal punctures~        2. Time required for the spinal anesthesia procedure~      Patients will be evaluated after 7 days for:~        1. Headache~        2. Backache~   "
133355|NCT01821781|"~     This study hypothesizes that a reduced intensity immunosuppressive preparative regimen will~     establish engraftment of donor hematopoietic cells with acceptable early and delayed toxicity~     in patients with immune function disorders. A regimen that maximizes host immune suppression~     is expected to reduce graft rejection and optimize donor cell engraftment.~   "
133356|NCT01821768|"~     This randomized clinical trial studies two different tests that are currently being used to~     detect the spread of breast cancer to the lymph nodes under the arm in candidates for breast~     conservation therapy. The two tests are sentinel lymph node biopsy (SLNB) and axillary~     ultrasound. The current standard of care is sentinel lymph node biopsy, which is a surgical~     procedure. Axillary ultrasound (AUS) may be just as good as SLNB for detecting the spread of~     cancer but without the surgical risks.~   "
133357|NCT01821755|"~     The hypothesis of the study is that the intervention leads to a reduction in foster~     children's externalizing problems and foster parents' parenting stress and that this in turn~     leads to a reduction in the number of breakdowns of foster placements.~   "
133358|NCT01821742|"~     A study to determine if echocardiographically derived parameters, plethysmographic~     variability index and pulse pressure variation predict fluid responsiveness in children on~     PICU.~   "
133359|NCT01821729|"~     This is a Phase II clinical trial, which tests the safety and effectiveness of an~     investigational combination of drugs to learn whether the combination of drugs works in~     treating a specific cancer. Investigational means that the combination of drugs is being~     studied. It also means that the FDA has not yet approved it for your type of cancer. Proton~     beam radiation therapy is an FDA approved radiation delivery system.~      Conventional radiation therapy uses photons to treat cancer before patients undergo surgery~     to remove the tumor. In this study we are using radiation with protons, which spares~     surrounding tissue and organs from radiation. Proton radiation delivers radiation to the area~     requiring radiation with no dose beyond the treatment area. This may reduce side effects that~     patients would normally experience with conventional radiation therapy.~      Researchers in the laboratory have discovered pathways inside cancer cells which contribute~     to the growth and survival of tumors. The FOLFIRINOX chemotherapy regimen is a combination of~     the drugs 5-fluorouracil, leucovorin and oxaliplatin. These chemotherapy drugs, along with~     the chemotherapy drug capecitabine, work by blocking these pathways and thereby preventing~     tumor growth. Capecitabine is FDA approved to be used alone or with other drugs to treat~     other types of advanced cancer, but not pancreatic cancer. In past research studies,~     FOLFIRINOX followed by radiation therapy with capecitabine has been identified as the most~     effective and active chemotherapy for patients with cancer that is spreading, and this is why~     we are using it to treat your type of cancer.~      Losartan is classified as an angiotensin-receptor blocker (ARB), and is FDA approved for use~     in people with high blood pressure. Recent studies in people with different types of cancer,~     including pancreatic cancer, have shown that combining chemotherapy drugs with an ARB can~     help reduce/stop tumor growth more effectively than chemotherapy alone. Losartan has been~     used in previous research studies, and information from those research studies suggests that~     this drug in combination with FOLFIRINOX and capecitabine may be better at treating your type~     of cancer.~      In this research study, we seek to determine whether combining FOLFIRINOX with Losartan~     before proton radiation therapy will be more efficient at controlling the growth of or~     shrinking your tumor than just FOLFIRINOX alone.~   "
133360|NCT01821716|"~     The objective of this study is to determine the biologic activity of a Dermatophagoides~     pteronyssinus allergen extract in histamine equivalent prick (HEP) units, in order to be used~     as in-house reference preparation (IHRP).~   "
133361|NCT01821703|"~     The purpose of this study is to investigate the safety and tolerability of LY3045697 after~     multiple doses and to determine how long LY3045697 remains in the body. Each participant is~     expected to complete 3 dosing periods. At least 7 days will pass between dosing periods.~   "
133362|NCT01821690|"~     The purpose of this study is to improve behavior control displayed by persons with traumatic~     brain injury by assessing effectiveness of treatments for post-TBI irritability and~     aggression.~   "
136174|NCT01784796|"~     The purpose of this study is to determine how a stress reduction program, called Mindfulness~     Based Stress Reduction (MBSR), compared to a health education program, improves well being~     and reduces the risk of heart disease in women Veterans. Recruitment completed.~   "
133363|NCT01821677|"~     This study will evaluate the efficacy of ultra low dose danazol (Optina) for the treatment of~     diabetic macular edema versus placebo. Optina has already been granted 505(b)2 status by the~     FDA and will incorporate all safety data from prior FDA approvals. Additional safety data~     will be collected specifically for this low dosage.~      This study will identify a population of subjects where Optina demonstrates a therapeutic~     effect.~      A portion of 505(b)2 drugs are approved based on a single clinical trial.~   "
133364|NCT01821664|"~     Background: Vascular grafts are increasingly implanted due to an increasing prevalence of~     atherosclerosis and diabetes, and about 1-6% of vascular procedures are complicated by~     infection. Mortality attributable to prosthetic vascular graft infections (PVGI) is high.~     However, there are almost no data regarding best treatment options of such complicated~     infections. Most recommendations are based on expert opinion and not on clinical trials or~     cohort observational data analyses. Evaluating infectious and other complications after~     vascular surgery procedures are important, and additionally, such studies may offer insights~     for quality improvement and improved patient outcomes. With the first aim investigators will~     establish an infrastructure for studying PVGI in Zurich. Investigators will take advantage of~     the Swissvasc registry, a central registry which collects preoperative, operative and~     discharge data regarding the index vascular surgical interventions. They will create a~     prospective observational cohort database of all patients who receive a vascular graft~     (peripheral, aortic, vein) at the University hospital of Zurich (VASGRA Cohort A). Patients~     with a PVGI will be included in VASGRA Cohort B and followed up using a flow chart with a~     focus on the course of this infectious complication. Additionally, investigators will~     establish a biobank with the collection of tissue- and blood samples of patients with PVGI.~     With the second aim researchers will investigate different diagnostic, clinical and~     therapeutic research questions nested in the VASGRA Cohort. Firstly, they will address~     epidemiological questions, such as: determine the incidence and outcome of complications~     after vascular graft placement; determine risk factors, best treatment strategies and outcome~     of PVGI, and determine the influence of different antibiotic regimens on the outcome of PVGI~     due to different bacterial pathogens. Secondly, investigators will determine the accuracy of~     different imaging techniques (PET/CT and MRI) for the diagnosis of PVGI, and their individual~     role for the assessment of treatment response. Thirdly, investigators will evaluate the~     bacterial diversity of vascular wound infections using 16s r-Ribonucleic acid~     (RNA)amplification, and investigators will explore whether this bacterial diversity does~     predict disease progression. Here, investigators will also study the impact of negative~     pressure wound therapy (NPWT) on bacterial diversity in the treatment course of PVGI.~     Fourthly, investigators will look for cut-off levels of relevant blood leucocytes count,~     C-reactive protein and procalcitonin raising suspicion of a PVGI. Lastly, investigators will~     look at histopathological features of excised vascular grafts. Expected value of the project:~     Results from the proposed study are an important contribution to the field, based on the~     large sample size, longitudinal design and by unifying clinical and epidemiological science.~     The very well characterized patient groups and the close connection between vascular~     surgeons, infectious disease specialists, specialists in nuclear medicine and microbiologist~     will help to investigate PVGI in depths. Investigators hope to be able to develop guidelines~     regarding best diagnostic modalities and treatment options in case of vascular graft~     infections. In the future we plan to examine bacteria retrieved from the PVGI in the~     laboratory in detail. The recovered bacteria will be examined for antimicrobial~     susceptibility and their capability to form biofilms. Furthermore investigators will examine~     how bacterial recovery form explanted grafts could be optimized.~   "
133365|NCT01821651|"~     Objectives:~      Goal of the study is to investigate the potential benefit that transcatheter interventions~     such as Transcatheter Aortic Valve Implantation (TAVI), MitraClip, Left Atrial Appendage~     Closure and catheter Ablation can gain from multimodal image fusion techniques as they are~     available in the Hybrid suite.~      Both the HeartNavigator and the EchoNav aim at decreasing the exposure to radiation and~     contrast agent, to shorten the operation time (efficacy), and to increase the quality of care~     (safety).~      This pilot study aims at observing these aims on a small patient population and a control~     group.~      Number of Subjects:~      140 patients total in 6 groups:~        -  MitraClip, Left Atrial Appendage Closure or catheter Ablation with EchoNav (20, lead-in~          stage).~        -  MitraClip randomized with EchoNav (25), MitraClip randomized without EchoNav (25).~        -  TAVI with HeartNavigator lead in (10)~        -  TAVI randomized with HeartNavigator (30), TAVI randomized without HeartNavigator (30).~   "
133366|NCT01821638|"~     Cognitive impairment, commonly reported as difficulty with memory and executive function, is~     a widely recognized clinical challenge for older persons with heart failure (HF). Little is~     known about the relationship between brain MRI and cognitive impairment in older persons with~     HF. A limited number of studies have investigated brain MRI in adults with HF and produced~     conflicting results. Previous findings are limited by use of lower resolution scanners (1.5~     Tesla), lack of MRI techniques (i.e. combining structural sequences with perfusion sequences)~     and recruitment of mixed age samples. Based on these limitations, the purpose of this~     research plan is to explore the relationship between brain MRI and cognitive impairment in~     older persons with HF using high resolution structural and perfusion scans. To accomplish~     this goal, investigators will compare 40 adults with HF who are age > 65 years old with 40~     healthy, gender, age, and education matched controls. Investigators will obtain~     neuropsychological measures of multiple domains, as well as MRI measurements of the temporal~     lobe and prefrontal cortex at baseline and 12-months.~   "
133367|NCT01821625|"~     This study will provide chronic hepatitis C (CHC) patients with low platelets (less than~     75x10^9/L) the opportunity to undergo treatment and possible cure of their virus. The main~     hepatitis C drugs will be administered as standard of care, with the addition of the study~     drug eltrombopag.~      The investigators hypothesize that providing eltrombopag to CHC patients with low platelets~     (less than 75x10^9/L) will permit the initiation and completion of antiviral triple therapy~     with boceprevir, ribavirin, and pegylated-interferon.~   "
133368|NCT01821612|"~     This pilot clinical trial studies combination chemotherapy and radiation therapy before~     surgery followed by gemcitabine hydrochloride in treating patients with pancreatic cancer.~     Drugs used in chemotherapy, such as oxaliplatin, irinotecan hydrochloride, leucovorin~     calcium, fluorouracil, and gemcitabine hydrochloride, work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination~     chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the~     amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill~     any tumor cells that remain after surgery.~   "
133369|NCT01821599|"~     The accelerated rehabilitation and early return does not seem to be harmful, but still needs~     further research to define the rehabilitation time is what shows Kruse and collaborators~     (2012) in their study of systematic review. The surgical treatment of anterior cruciate~     ligament injury is the gold standard in the treatment of these injuries in young and active,~     the postoperative rehabilitation is extensive and full return to sport occurs only after 6~     months postoperatively. Based on this gap, the investigators seek to draw properly through~     our study methods and more complex techniques, that comparing two rehabilitation programs can~     achieve high precision early rehabilitation. This will include 32 athletes who had complete~     ACL rupture confirmed by MRI and underwent ACL reconstruction using patellar tendon.All~     subjects will be followed from the pre-surgery, the fourth and sixth month after surgery~     with: KT1000 measures the ligamentous laxity, knee function by applying the International~     Knee Documentation Committee (IKDC 2000); Isokinetic Muscle Strength (Cybex). Through a~     random draw of sealed envelopes, patients will be allocated in their rehabilitation groups:~     Accelerated (4 months) or Conventional (6 months). Preoperatively, fourth and sixth month~     after surgery will be an assessment of laxity by (KT1000), Muscular Strength (CYBEX) and knee~     function affected by IKDC (2000) and Hop Test. The assessor and the patients were blinded to~     treatment group. This study will have the locus Institute of Orthopaedics and Traumatology,~     School of Medicine, São Paulo. The comparative results of the two groups are analyzed using~     specific statistical tests to prove an improved significative without damaging the integrity~     of the graft.~   "
133379|NCT01821469|"~     This research project follows two main objectives: 1) Assess anatomical and functional~     cerebral abnormalities in bipolar disorder. 2) Evaluate anatomical and functional changes~     after the application of a psychoeducational program in these patients. Specifically, this~     project aims to assess neurophysiological (fMRI - activation and functional connectivity) and~     neuroanatomical (morphometry and diffusion tensor imaging) specificities related to bipolar~     disorders and the therapeutic response to the psychoeducation. The results of this thesis~     project would also contribute to the validation of a pathophysiological model of the bipolar~     disorder.~   "
133380|NCT01821456|"~     The Cologne Cohort of Neutropenic Patients (CoCoNut) is a non-interventional cohort study~     assessing risk factors, interventions, and outcome of immunosuppressed patients with or~     without opportunistic infections.~   "
133442|NCT01820624|"~     This phase I trial studies the side effects and best dose of tretinoin when given together~     with lithium carbonate in treating patients with relapsed or refractory acute myeloid~     leukemia. Lithium carbonate may stop the growth of cancer cells by blocking some of the~     enzymes needed for cell growth. Tretinoin may help [type of cancer] cells become more like~     normal cells, and to grow and spread more slowly. Giving lithium carbonate together with~     tretinoin may kill more cancer cells~   "
133370|NCT01821586|"~     Diarrhoea and malnutrition are the common childhood illnesses responsible for higher deaths~     in developing counties. Physiologically, malnourished children excrete lower amounts of salts~     and water in diarrhoeal stools, and they also are unable to handle excessive salts and water~     load. Some times they are found to be hyponatraemic due to the shift of sodium inside the~     cells (inefficient Na+ /K+ pump), and fluids containing higher amounts of sodium (such as the~     standard ORS) may lead to further increase in the intracellular sodium, fluid overload and~     heart failure. They also have depleted in potassium stores in the body. Recently, the WHO~     recommended a special ORS formulation, known as ReSoMal, for management of diarrhoea in~     severely malnourished children that contains a lower amount of sodium (45mmol/L) and higher~     amount of potassium (40 mmol/L) than the standard WHO-ORS. It is felt that an ORS containing~     lower sodium and higher potassium concentration may be useful in correcting hypokalemia, and~     in lowering the risks of excess sodium and /or overhydration, in severely malnourished~     children with diarrhoea. The safety of ReSoMaL is, however, still in question due to the risk~     of hyponatraemia, including symptomatic hyponatraemia, especially in the treatment of severe~     watery diarrhoea due to Vibrio cholerae and ETEC where loss of sodium in the stool exceeds~     than that is contained in ReSoMal. Thus an ORS solution with modest concentration of sodium~     (75 mmol/L) and higher concentration of potassium (40 mmol/L) have been suggested for the~     treatment of diarrhoea in these children. To improve the efficacy of oral rehydration, in~     terms of reducing the severity of purging and diarrhoea duration, different approaches~     (changing the substrates/ reducing the sodium and glucose concentration and osmolarity) have~     been tried with limited success. Benefiber (partially hydrolysed guar gum), a soluble fiber~     if added to a ORS solution is expected to be fermented in the colon liberating short chain~     fatty acids (SCFAs). SCFAs stimulate sodium and water absorption from the colon, and they~     have trophic effect, act as a fuel source for the colonocytes, have antibacterial properties~     and stimulates the production commensal flora, thereby may enhance recovery from acute~     diarrhoea in severely malnourished children. The aims of our proposed study are to examine~     whether an ORS solution with a modest concentration of sodium will prevent the occurrence of~     hyponatraemia including symptomatic hyponatraemia, and also whether addition of benefiber~     will improve the efficacy of ORS solution. This will be a randomized, double blind,~     controlled clinical trial in 186 children with severe malnutrition and watery diarrhoea (62~     in each of the three treatment groups) to compare the efficacy of (i) the currently~     recommended ORS with some modofication(Na+ 75 mmol/L and K40 momol/L and minerals-Zinc,~     copper and magnesium), (ii) ReSoMal (Na+ 45 mmol/L), (iii) Currently recommended ORS (Na+ 75~     mmol/L, K 40 momol/L and added minerals) with added Benefiber (25 grams/L), in the treatment~     of acute watery diarrhoea in children with severe malnutrition~   "
133371|NCT01821573|"~     The aim of this randomized controlled study is to quantify the modification during locomotion~     of chronic hemiparetic patients of the strength and the length of Rectus Femoris and Triceps~     Surae induced by botulinum toxin injection type A.~      The main hypotheses of this study based on previous studies are that botulinum toxin~     injection increases on one hand the length of the muscle injected during gait and on the~     other hand decreased the strength of the muscles injected.~      The investigators also hypothesized that botulinum toxin injection improved the strength of~     the antagonist muscles and normalized the pattern of strength of the muscles injected during~     gait.~   "
133372|NCT01821560|"~     The proposed project will utilize perfusion functional magnetic resonance imaging (fMRI), a~     functional candidate gene association approach (of dopaminergic addictions-targeted~     polymorphisms), and the dopamine-modulating and gamma-aminobutyric acid (GABA) B receptor~     agonist, baclofen, to examine the brain and behavioral responses in smokers to appetitive~     smoking reminders (cues that motivate continued smoking and relapse). These studies will~     provide a means to identify an appetitive cue-sensitive pharmacologic-responsive~     endophenotype. Once brain/behavioral/genetic endophenotypes can be determined prior to~     treatment, smoking cessation treatments can be structured to meet individual needs, which~     will significantly improve treatment outcome.~   "
133373|NCT01821547|"~     Hepatitis B vaccine is a safe and effective vaccine used widely throughout the world. Because~     of this it is a useful vaccine in which to develop new methods for studying immune responses.~     Measuring the immune response to vaccines helps us to understand how they work and whether~     they are likely to protect any individual against infection. For most vaccines we measure the~     immune system's production of antibody after a vaccine has been given. The investigators want~     to develop new methods that give a far more detailed picture of the antibody response to~     vaccines than has previously been possible. These methods will investigate the genetic~     instructions used by each antibody producing cell to make antibody. These methods have the~     potential to give new insights into the way vaccines work, which could be applied to studying~     vaccines and vaccine schedules in the future.~   "
133374|NCT01821534|"~     This study will evaluate the inter-rater and intra-rater reliability of a Masseter Muscle~     Prominence Scale for evaluating a patient's muscle prominence and a Lower Shape~     Classification for evaluating a patient's lower facial shape.~   "
133375|NCT01821521|"~     Primary object : Evaluate pharmacokinetic property administered S-pantoprazole 20mg and~     Pantoprazole 40mg in healthy male subjects~      Secondary object : Evaluate safety administered S-pantoprazole 20mg and Pantoprazole 40mg in~     healthy male subjects~   "
133376|NCT01821508|"~     This is a prospective, open, randomized study involving 100 patients with microvascular~     complications of type 2 diabetes mellitus and obesity, who will undergo gastric bypass~     (Roux-en-Y gastric bypass ARM A) or receive best medical treatment (ARM B, control arm).~      The aim of this study is to evaluate the effects of Roux-en-Y gastric bypass in the control~     of diabetic nephropathy in diabetic patients with BMI between 30 and 35 kg/m2.~      The medical community is confronted with many different studies using various methodologies~     to investigate the best pharmacological treatment for type 2 diabetes mellitus. The treatment~     algorithm offers several different options according to the stage of the disease (which is~     different in each study). In addition, new drugs are being developed over the years, but are~     not always a guarantee of effective type 2 diabetes mellitus control [MENDES, 2010].~     Furthermore, these drugs do not prevent the development of this disease, consequently~     increasing the risks of microvascular and macrovascular complications.~      Conversely, there is considerable evidence that surgery can be an adequate tool to promote~     type 2 diabetes mellitus remission in patients who are unresponsive to clinical treatment.~     Gastric bypass surgery is one of the most popular bariatric surgeries in the world, but its~     effects on microvascular and macrovascular complications of type 2 diabetes mellitus have not~     been established. Specialists suggest that the rapid and uncontrollable decrease in blood~     glucose adds to the concern that the surgery may paradoxically cause exacerbation of~     microvascular complications [LEOW, 2005], whereas gradual improvement in blood glucose before~     gastric bypass surgery may prevent this paradoxical worsening, leading to an interruption of~     this process, or even retinopathy, nephropathy, and neuropathy remission.~      However, there are no studies comparing the results of these two types of treatment (clinical~     vs. surgical) in a similar population and assessing the development of microvascular~     complications of type 2 diabetes mellitus. Therefore, in order to clarify such doubts, it is~     necessary and extremely desirable to conduct a randomized controlled trial comparing gastric~     bypass with the best and most modern clinical treatment. Its findings could have a direct~     impact on hundreds of millions of diabetics by allowing the inclusion of surgical treatment~     as a safe and feasible therapeutic option for a significant portion of these patients.~   "
133377|NCT01821495|"~     Concurrent of radiotherapy and chemotherapy is the main treatment method for patients with~     nasopharyngeal carcinoma (NPC). However, Relapse remains the major cause of treatment~     failure. A series of studies reported that dendritic and cytokine-induced killer cells~     (DC-CIK) have a broad anti-tumor spectrum. We suppose that DC-CIK will improve the prognosis~     of NPC. In this study, the patients with NPC will be treated with DC-CIK cells after~     concurrent of chemotherapy and radiotherapy. The purpose of this study is to evaluate the~     efficacy of DC-CIK for NPC.~   "
133378|NCT01821482|"~     The purpose of this study is to evaluate the efficacy of Dendritic and Cytokine-induced~     Killer Cells (DC-CIK) for hepatocellular carcinoma (HCC).~   "
133443|NCT01820611|"~     The primary purpose of this study is to evaluate the clinical performance of the Arcos~     Revision Stem system, determine the stability of the implants, and evaluate any relationship~     between Paprosky bone defect level and the success of the Arcos Stem.~   "
136175|NCT01784783|"~     The purpose of this study is to investigate the impacts of home-based couple HIV-testing and~     counseling and male partner education on partner HIV testing and other critical maternal and~     infant health outcomes during pregnancy and the postpartum period. Additionally, the study~     seeks to assess the cost-effectiveness of this approach.~      Involvement of men during the antenatal and postpartum period, including HIV testing of male~     partners, can have substantial benefits for women and infants. In observational studies, male~     participation in antenatal care has been associated with increased uptake of prevention of~     mother-to-child transmission (PMTCT) interventions, and more recently, a study in Kenya found~     a significant HIV-free survival benefit for children of HIV-infected women whose male~     partners attended antenatal care where couple HIV testing was offered. In this study only 31%~     of ~450 men invited for counseling and testing came to clinic, highlighting the challenges~     faced across sub-Saharan Africa when trying to access male partners of pregnant women.~      In areas of high HIV-1 prevalence, high levels of male involvement may be readily achievable~     because home-based counseling and testing is highly acceptable and the benefits of male~     participation and HIV testing extend to HIV-uninfected pregnant and postpartum women and~     infants. Reaching out to men during pregnancy may reduce incident HIV infection and vertical~     transmission among these women, but efforts to engage men in antenatal care in Western Kenya~     have thus far achieved limited success. This intervention may achieve gains beyond prevention~     of maternal and infant HIV-1 acquisition through identification of HIV-infected men who would~     otherwise not learn their status or delay treatment, and by improving child health through~     targeted education of male partners. When administered in a home-based setting simple,~     established interventions such as the promotion of exclusive breastfeeding have been shown to~     be associated with significant reductions in child mortality. Home-based approaches also lend~     themselves to integration with targeted interventions such as promotion of HIV testing among~     male partners of at-risk pregnant women. Furthermore, a successful HIV testing program for~     male partners of pregnant women has potential to reach a large number of men who may be~     unaware of their HIV status or who are HIV-infected but not in care, providing linkages to~     treatment clinics and promoting prevention interventions, such as safe sex and voluntary male~     circumcision for those who are uninfected.~      In this randomized clinical trial up to 600 couples (300 in each treatment arm) will be~     randomized to standard antenatal care or home-based partner education and HIV testing (HOPE)~     as part of routine pregnancy services. Women will be enrolled at the antenatal clinic in~     Kisumu District Hospital, Kisumu, Kenya. Couples in the control group will receive the HOPE~     Intervention, featuring home-based couple counseling and HIV testing as well as key~     educational messages concerning HIV prevention behaviors, facility delivery, exclusive~     breastfeeding, and post-partum family planning. Women in the control arm will be invited to~     bring their male partners to the antenatal clinic for voluntary clinic testing and~     counseling. Women will be followed up at clinic visits 6-weeks and 14-weeks postpartum and~     again with their male partner 6-months post-partum. These follow-up visits will include~     questionnaires to measure uptake of HIV testing, facility delivery, exclusive breastfeeding~     and postpartum contraceptive use as well as linkage to HIV care. Cost-effectiveness of the~     intervention will also be evaluated in order to inform future scale-up.~      First, the investigators hypothesize that successful implementation of HOPE will result in~     higher uptake of male partner HIV testing, couple testing and disclosure of HIV status. The~     investigators also hypothesize that there will be benefits to HIV-infected and HIV-uninfected~     women and their children who will have improved uptake of interventions to improve maternal~     and child health. Specifically, the investigators anticipate higher levels of facility~     delivery, optimal breastfeeding practices, and post-partum contraceptive use, as well as~     increased uptake of antiretroviral treatment for HIV+ women in the intervention arm, relative~     to the control arm. Second, the investigators hypothesize that greater than 85% of~     HIV-1-infected men identified through home-based partner education and testing (HOPE) will~     access care and treatment services, and, overall, more women in the HOPE arm will know their~     partners' status at each time point and more partners will be in care and treatment. Third,~     the investigators predict that uptake of counseling and testing and HIV prevalence among male~     partners and family members will be high enough to make this approach cost-effective from~     both payer and societal perspectives.~   "
133381|NCT01821443|"~     The purpose of this study is to find out what effects, good and/or bad, stereotactic~     radiosurgery (Gamma knife) has on brain metastasis(es). Gamma knife radiosurgery is a way of~     giving radiation therapy to the brain in a very focused way, so that nearby parts of the~     brain receive very little exposure to radiation. No incisions are involved. Imaging~     technology is used to pinpoint the location of the tumor.~      In this study, the investigators are also trying to find out how the tumor and/or treatment~     affect brain function over time. The investigators will do this by performing a series of~     neurocognitive assessments, or tests of memory, reasoning, and higher brain function, before~     treatment and at regular intervals after treatment.~   "
133382|NCT01821430|"~     Managing pain in patients who abuse prescription opioids presents many challenges, including~     the development of opioid-induced hyperalgesia (OIH). Hyperalgesia is a condition in which~     something that usually feels slightly painful is perceived as something very painful. The~     proposed study will test the efficacy of the well-known neurological medication pregabalin to~     diminish OIH and chronic pain in persons who are in Suboxone (buprenorphine) or methadone~     treatment for prescription drug abuse.~   "
133383|NCT01821417|"~     The study will compare initial peri-implant bone healing and longitudinal osseointegration~     between a fully microtextured dental implant and an analogous implant with a smooth machined~     collar.~      The investigators hypothesize the fully textured implant will result in less peri-implant~     crestal bone resorption than the implant with a machined collar.~   "
133384|NCT01821404|"~     This single-center, randomized, double-blind trial assesses the impact of short-term~     atorvastatin administration on proliferation activity, apoptotic rate and histological~     inflammation in prostate tissue.~   "
133385|NCT01821391|"~     This study will be conducted as a multi-centre, randomized, investigator-blind, active and~     vehicle-controlled, intra-individual study.~      The purpose of this study is to confirm that the Metvix NDL-PDT procedure is similar in~     efficacy and less painful when compared to Metvix c-PDT procedure for the treatment of mild~     and moderate AKs.~      In addition this study will include a Metvix NDL-PDT arm versus Metvix vehicle cream c PDT~     (Placebo) to assess the sensitivity of the trial.~   "
133386|NCT01821378|"~     The primary purpose of this study is to evaluate the efficacy of lurasidone 20 mg/day in~     subjects with an acute exacerbation of schizophrenia.~   "
133387|NCT01821365|"~     Sidestream end-tidal CO2 has been found to be closely correlated to PaCO2 especially when~     people have the stable hemodynamics and normal lung function. PETCO2 can basically reflect~     the level of PaCO2,but some investigators found that PETCO2 measurements did not reflect~     PaCO2 in COPD patients.There may be several reasons for this discrepancy. Due to airway~     obstruction and ventilation-perfusion mismatch, there is a delay in the maximum alveolar~     concentration of CO2 reaching the cannula, which may give lower PETCO2 values compared with~     PaCO2. To overcome this disadvantage, we tried to prolong their expiratory time (extend to~     5-8s) in order to guarantee adequate time for alveolar CO2 reaching the cannula.our study~     mainly focus on two issues.First, to explore the optimal depth of tube placed when patients~     with COPD breathe spontaneously or receive noninvasive ventilation, and compare the~     differences of two condition at the same time. Secondly, to evaluate the agreement between~     the PaCO2 and sidestream PETCO2（5s）values in COPD patients receiving noninvasive ventilation~     when our extension tube locates in the optimal position, and investigate whether~     PETCO2（5s）can be used to monitor ventilation status dynamically.~   "
133388|NCT01821352|"~     The purpose of this study is to determine whether low level laser light therapy is effective~     in reducing circumference of the waist, hips and upper abdomen in obese individuals.~   "
133389|NCT01821339|"~     The purpose of this study is to determine whether displacement on one or all of the standard~     radiography views done within 6 months and 1 year after a pelvic injury is related to health~     related quality of life outcomes of patients with an isolated pelvic ring injury.~   "
133390|NCT01821326|"~     The investigators investigated the rebleeding rate the risk factors for rebleeding after~     long-term follow-up (≥12 months) in patients who underwent capsule endoscopy for obscure~     gastrointestinal bleeding.~   "
133391|NCT01821313|"~     The purpose of this study is to examine the effects of high intensity interval exercise~     (HIIE) on inflammation and endothelial dysfunction found in children with obesity. Our~     working hypothesis is that, compared with obese children prescribed moderate exercise, obese~     children prescribed HIIE will demonstrate greater improvements in endothelial function and~     inflammatory markers following a 6-week exercise intervention.~   "
133392|NCT01821300|"~     The purpose of this research study is to determine which measures best capture cardiovascular~     disease (CVD) risk and type 2 diabetes (T2DM) risk in children and adolescents with Down~     syndrome (DS).~      We hypothesize that DS is associated with worse cardiometabolic risk factors for a given body~     mass index compared to controls. This difference arises at least in part, from increased fat~     tissue.~   "
133393|NCT01821287|"~     The purpose of this study is to understand the causes of growth failure and to define~     biochemical markers of nutritional failure in patients with single ventricle Congenital Heart~     Disease (CHD).~   "
133394|NCT01821274|"~     The purpose of the study is to determine whether Diltiazem Hydrochloride 2% Cream will cause~     irritation to skin on the back of healthy volunteers after repeated application over 21-days.~   "
133395|NCT01821248|"~     To evaluate the efficacy and the safety of preoperative chemotherapy with Gemcitabine/~     Cisplatin /S-1 for biliary tract cancers with lymph node metastasis by FDG-PET.~   "
133396|NCT01821235|"~     The NO SWITCH list is based on the hypothesis that the pharmacokinetic differences between~     different batches of one medicines are smaller than the pharmacokinetic differences between~     two medicines (from a different manufacturer, e.g. brand versus generic medicine). The aim of~     this study is to investigate the hypothesis using gabapentin as test product. Therefore, the~     first objective of this study is to investigate the individual bioequivalence - or~     switchability - of Gabasandoz® 800 mg relative to Neurontin 800 mg®. The second objective is~     to investigate the individual bioequivalence between two different batches of the same~     medicine, for Gabasandoz® 800 mg and Neurontin® 800 mg.~   "
133471|NCT01820247|"~     The purpose of this study is to assess the effect of Tripterygium Glycosides Combined with~     enteral nutrition in the treatment of Crohn's disease for induction remission and compare the~     therapeutic effect with patients who only received Tripterygium Glycosides or enteral~     nutrition.~   "
133397|NCT01821222|"~     Reducing maternal and newborn mortality remains a global challenge. Because obstetric~     complications cannot be predicted, skilled attendance at the time of delivery and access to~     emergency obstetric care remain the most effective strategies to reduce mortality. Antenatal~     care has the potential to reduce maternal morbidity and improve newborns survival but this~     benefit may not be realized in sub-Saharan Africa where the attendance and quality of care is~     declining. There is a rapidly expanding number of mobile phone users in developing countries~     and due to the potential to strengthen health system the use of mobile phones is health care~     is emerging. The investigators assessed a mobile phone intervention named wired mothers~     aimed to improve maternal and newborn health.~      The hypothesis of the study was that the wired mothers mobile phone intervention would~     increase attendance to essential reproductive health services such as antenatal care and~     skilled delivery attendance and reduce severe adverse pregnancy outcomes for women and~     newborn.~      The objective of the study was to examine the effect of the wired mothers intervention on~     antenatal care, skilled delivery attendance, access to emergency obstetric care and perinatal~     mortality.~      The study was a pragmatic cluster randomized controlled trial with the primary health care~     facility as the unit of randomization. The study took place in 2009-2010 on the island of~     Unguja in Zanzibar. 2550 pregnant women who attended antenatal care at one of 24 selected~     facilities were included at their first visit and followed until 42 days after delivery.~     Facilities were allocated by simple randomization to either mobile phone intervention (n=12)~     or standard care (n=12). The intervention consisted of a SMS and mobile phone voucher~     component.~      The perspectives of the study are that mobile phones may contribute to saving the lives of~     women and their newborns and achievement of MDGs 4 and 5. Evidence is needed to guide~     maternal and child health policy makers in developing countries.~   "
133398|NCT01821209|"~     Placement of an autologous retropubic urethral sling at the time of robot assisted radical~     prostatectomy will improve the recovery of continence after radical prostatectomy~   "
133399|NCT01821196|"~     Preclinical studies at our institution, based on a genetic mouse model of stomach cancer,~     strongly suggest that innervation of the stomach wall is deeply involved in tumorigenesis of~     stomach cancer. The data indicate that denervation of the stomach either by vagotomy or by~     injection of botulinum toxin (Botox®)in the stomach wall inhibits the development of cancer~     as well as reduces already established tumor volume in the stomach in this mouse model. Gene~     expression data indicate that vagotomy suppresses protein gene product 9.5 (PGP9.5). The~     expression of PGP9.5 is highly specific for the density of neurons and the diffuse~     neuroendocrine system. The investigators will take biopsies from tumors and adjacent normal~     mucosa either by means of endoscopy and/or from operative specimens from participants treated~     or evaluated for stomach cancer at the Department of Gastrointestinal Surgery, St Olavs~     Hospital, Trondheim University Hospital. The biopsies will be evaluated with~     immunohistochemistry and gene expression studies for the presence and density of PGP9.5.~     These data will be correlated to stage evaluation (TNM) and survival.~   "
133400|NCT01821183|"~     At this investigation we want to find out whether there is a difference in muscle strength of~     the internal and external rotation hip muscles between soccer players and non-soccer players~     caused by typical movement patterns seen in soccer sport.~   "
133401|NCT01821170|"~     The Attention Deficit Disorder with or without Hyperactivity (ADHD) is one of the most~     frequently found disorder in children. It is characterized by a triad of symptoms involving~     attention deficit, hyperactivity and impulsivity and having an impact on the functioning of~     the subject especially in terms of learning.~      Currently, main interventions to treat ADHD in children are stimulant medication or~     supportive psychotherapy. Data from recent studies highlight the use of stimulant drugs~     (amphetamine derivatives such as methylphenidate) to treat the core symptoms of ADHD~     children. These drugs are generally effective but their nature (psychostimulants) and adverse~     effects they cause (appetite suppression, sleep disturbances, headaches, motor tics,~     abdominal pain, irritability, nausea and fatigue) encourage the development of new~     therapeutic approaches. The use of supportive psychotherapy alone would have limited effect~     on symptoms of children with ADHD. Our aim is to test the use a cognitive remediation program~     using a virtual classroom in children suffering from ADHD.~   "
133402|NCT01821157|"~     The aim of this study is to compare the clinical outcomes of open-flap (OF) and flapless (FL)~     esthetic crown lengthening (ECL) for the treatment of excessive gingival display (EGD). It~     was hypothesized that the FL surgery would yield similar clinical results to the OF technique~     up to 12 months. Methods: A split-mouth randomized controlled trial will be conducted in 28~     subjects presenting EGD. Contralateral quadrants will receive ECL using OF or FL techniques.~     Clinical parameters will be evaluated at baseline, 3, 6 and 12 months post-surgeries. The~     local levels of receptor activator of NF-КB ligand (RANKL) and osteoprotegerin (OPG) will be~     assessed by ELISA at baseline and 3 months. Patients' perceptions regarding morbidity and~     esthetical appearance will be also evaluated. Periodontal tissue dimensions will be obtained~     by computed tomography at baseline and correlated with the changes in the gingival margin~     (GM).~   "
133403|NCT01821144|"~     The study is to test whether an education programme targeted at school children can lower~     salt intake in children and their families. In this study, the investigators will educate~     children on how to reduce salt intake, and the investigators will empower children by asking~     them to deliver the salt reduction message home to their families, particularly children need~     to persuade the person who does the cooking for the whole family to cut down on the amount of~     salt used during food preparations. The study will involve children aged about 11 years, and~     their parents and grandparents in Northern China.~   "
133404|NCT01821131|"~     This Clinical Trial is being conducted to study the LDL (bad) cholesterol lowering abilities~     of flax. The purpose of this study is to find the lowest dose of flax that can lower~     LDL-cholesterol.~   "
133405|NCT01821118|"~     Cerebral Amyloid Angiopathy (CAA) is a condition caused by the build-up of a protein called~     amyloid, predominantly Aβ40, within the walls of brain blood vessels, especially those blood~     vessels in the occipital lobe of the brain. Probable CAA may be defined as two or more~     hemorrhages in the brain cortex in individuals 55 years of age or older. This study will~     examine the study drug (PF-04360365) vs. placebo (saline) at 10 mg/kg - Day 1 and the~     maintenance dose of the study drug (PF-04360365) vs. placebo (saline) at 7.5mg/kg on Days 30~     and 60. Subjects will be followed for 6 months after receiving the last dose of study~     medication.~   "
133406|NCT01821105|"~     This pilot phase II studies how well computed tomography (CT) and positron emission~     tomography (PET) imaging works in detecting disease in patients undergoing surgery for~     metastatic colorectal cancer. Diagnostic procedures, such as CT and PET scans, done before~     and during surgery may help find colorectal cancer and help guide surgery~   "
133495|NCT01819935|"~     The purpose of this non-interventional, retrospective study of existing data is to evaluate~     clinical outcomes related to Methicillin-resistant Staphylococcus aureus hospital based~     pneumonia by treatment and among subpopulations.~   "
133407|NCT01821092|"~     40 consecutive adult patients, requiring the insertion of dental implants in the aesthetic~     area (from second premolar to second premolar) will be enrolled in the study. At the time of~     surgery, a full thickness flap will be elevated, the implant bed will be prepared according~     to the manufacturer's instruction and the implants will be then seated into the bone. T0~     corresponds to the time of implant insertion, T1 to the time of healing abutment's connection~     (T0=T1 for single stage implants), and T2 corresponds to 1-year follow-up from healing~     abutment's connection.~      Cone Beam Computed Tomography (CBCT) scans will be taken immediately after abutment~     connection (T1) and 1-year after (T2). The midsagittal cut of each implant will be~     identified, and measurements will be made at predetermined levels. Horizontal facial bone~     thickness (HFBT) and Vertical facial bone level (VFBL) will be measured. HFBT will be~     measured at 0, 3, 6 and 9 mm apical to the implant platform. VFBL wil be the perpendicular~     distance from the implant platform to the most coronal point of the facial bone. Changes~     between T1 and T2 will be calculated.~   "
133408|NCT01821079|"~     The purpose of this study in healthy volunteers is to assess the relative bioavailability of~     PF-05175157 as powder-in-capsule and a tablet formulation and the effect of food on the~     pharmacokinetics of the tablet formulation.~   "
133409|NCT01821066|"~     A single 125 mg oral dose of the investigational compound PD-0332991 will be administered~     alone and after steady-state dosing of tamoxifen to determine if coadministration of~     tamoxifen alters the plasma pharmacokinetics of PD-0332991 in healthy male volunteers.~   "
133410|NCT01821053|"~     A tonic active epithelial Na+ channel (ENaC) in pre-eclampsia (PE) escaped normal hormonal~     control may offer an attractive explanatory model for the pathophysiology of established PE.~     The channel is activated by plasmin. Microalbuminuria predicts the development of~     pre-eclampsia in pregnant patients with pregestational diabetes type 1. The investigators~     hypothesize that urine-plasmin excreted in the kidneys, when proteinuria occurs, could be the~     cause. The investigators want to test the correlation between measurable plasmin/plasminogen~     in the urine early in pregnancy and the development of preeclampsia in pregnant patients with~     type 1 diabetes.~   "
133411|NCT01821040|"~     The study compares the efficacy and safety of modified release prednisone versus immediate~     release prednisone in patients suffering from polymyalgia rheumatica.~   "
133412|NCT01821027|"~     The purpose of this study is to determine how multiple doses of canagliflozin (JNJ-28431754)~     affect the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how~     the drug affects the body) of a single dose of simvastatin.~   "
133413|NCT01821014|"~     Much of the basic general medical care and chronic disease management in rural Honduras comes~     from groups of volunteers setting up temporary clinics run by volunteers. These clinics, also~     known as brigades, or medical missions, are often criticized for their lack of quality and~     the lack of follow-up, both of which stem, in part, from understaffing with volunteer~     physicians. This study is designed to assess if it is feasible, safe, and acceptable to treat~     patients in short-term mobile medical clinics in rural Honduras using US physicians connected~     with patients by videoconference.~   "
133414|NCT01821001|"~     Adenomyosis is a rare non-malignant disease of the uterus that causes significant symptoms~     including heavy menstrual bleeding and pelvic pain. The only widely accepted treatment for~     adenomyosis is hysterectomy. The investigators will use a dopamine agonist, bromocriptine, as~     a therapy based on animal models of the disease and our prior clinical research to observe~     any objective improvement in the extent of the disease using Magnetic Resonance Imaging~     (MRI)and standard measurements for other gynecologic diseases to measure symptomatology.~   "
133415|NCT01820988|"~     The objective of this cross-sectional study is to obtain insight in the characteristics~     (nutritional status and level of physical activity) of sarcopenic compared to non-sarcopenic~     community-dwelling older people. There is one measurement moment and measurements will take~     place at the participant's home.~   "
133416|NCT01820975|"~     In the present study, the effect of habitual dietary protein on the anabolic response will be~     investigated.~   "
133417|NCT01820962|"~     Patients with a hematological malignancy who are undergoing intensive chemotherapy need a~     central venous catheter (CVC)during their treatment. CVCs are locked with heparin when they~     are not used.~      The purpose of this study is to determine whether concentrated citrate locking, compared to~     heparin, reduces the incidence of central venous catheter-related thrombosis and infections~     in patients with hematological malignancies undergoing intensive chemotherapy.~   "
133418|NCT01820949|"~     This study will evaluate clinical outcome after the step-wise implementation of a Patient~     Blood Management (PBM) Program in surgical patients at 4 hospitals.~   "
133419|NCT01820936|"~     The purpose of this study is to compare the effect of food and two modified fasting regimens~     on the pharmacokinetics (study of what the body does to a drug) of PCI-32765 in healthy adult~     participants.~   "
133420|NCT01820923|"~     The aim of this study is to determine whether transcranial brain stimulations, such as~     repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current~     stimulation (tDCS), are effective in terms of EEG coherence and clinical changes in patients~     in vegetative and minimally conscious state.~   "
133421|NCT01820910|"~     Objective of this trial is to establish the efficacy of an upfront targeted therapy~     consisting of Chlamydophila psittaci (Cp)-eradicating therapy with prolonged administration~     of doxycycline followed by eradication monitoring and antibiotic re-treatment at infection~     re-occurrence in patients with newly diagnosed ocular adnexae marginal zone lymphoma The~     primary endpoint is the 2-year progression-free survival (PFS) of patients with newly~     diagnosed stage-IE lymphoma treated with the experimental strategy.~   "
133422|NCT01820897|"~     Urinary tract infections (UTI) are the most common complications after kidney~     transplantation. Most series have reported incidence between 20 to 50% during the first year.~     In the most recent report from our center the incidence was 36.6% during the first 6 months~     after transplantation.~      The clinical consequence in the graft survival and the association with immunological~     rejection has not been well defined. Nevertheless, the association of UTI with high rate of~     hospitalization and their costs are widely recognized. There is paucity of trials, specially~     randomized and controlled, comparing antibiotic prophylaxis in this group of patients. In a~     recently published metaanalysis Green et al. (Transpl Infect Dis. 2011 Oct;13(5):441-7) found~     only 6 clinical trials well designed, the conclusion was that antibiotic prophylaxis reduced~     the incidence of UTI and the risk of sepsis. Based in this information, the KDIGO guidelines~     in transplantation recommend the prophylaxis for UTI with sulfamethoxazole-trimethoprim~     (SMT). Nevertheless, the rate of bacterial resistance to SMT has been reported above 50% in~     almost all the series.~      Fosfomycin-trometamol (FT) is a wall antibiotic (piruvil-tranferase inhibitor) that has shown~     a good bioavailability, especially in the urinary tract. It has shown a wide antibacterial~     spectrum, but the important target seems to be enteric bacilli particularly Escherichia coli~     (the most prevalent cause of UTI). FT has also shown a very good activity against E. coli~     producer of Extended Spectrum Betalactamases. Recently, the rate of these multi-drug~     resistant bacteria has increased in our center as evidence of worldwide distribution. In~     addition, the rate of FT resistance has been stable during the last years (<3%). This~     phenomenon could be explained because of the properties of this antibiotic, the most~     important one seems to be related with the unique mechanism of action and the lack to~     propagate the mechanisms of resistance at least in E. coli. There is only one clinical trial~     (randomized and controlled), which compared FT with placebo in UTI prophylaxis; 317 women~     with recurrent UTI (three by year) were included. They found rates of 0.14 and 2.9~     episodes/patient/year, respectively (p<0.001). Furthermore, there was no FT resistance during~     the follow up.~      Our hypothesis is that in the first six months after kidney transplantation, UTI prophylaxis~     with FT will show greater efficacy in comparison with SMT. Considering the incidence of UTI~     in our center (36.6%) and the rate of UTI in the unique trial of prophylaxis with FT (14%),~     65 patients will be needed by group of treatment to demonstrate a difference of 22% in the~     incidence of UTI, with a power of 80% and confidence level of 95%. The primary outcome is the~     incidence and rate of UTI during the first six months after kidney transplantation. The~     secondary outcomes are, the hospitalization rate, antibiotic resistance rate, rejections and~     titer and number of de novo donor specific antibodies.~      The investigators propose a randomized, double blind, placebo controlled trial to compare FT~     with SMT in the efficacy and safety to prevent UTI during the first six months after kidney~     transplantation. The investigators will include patients from two tertiary-care transplant~     centers. Recruiting and the randomization will be carried out separately by center and gender~     (because female patients have a greater risk of UTI). The medical visits will be scheduled~     monthly and include general laboratory, urine culture and information gathering about~     antibiotic side effects as well as adherence. Rejection rate and the number and titers of de~     novo donor specific antibodies (secondary outcome) will be obtained according to the standard~     of care of the institutional kidney transplantation follow up. These include kidney biopsy at~     days 0 and 90 after transplantation, as well as determination of donor specific antibodies~     after sixth months of follow up. Graft biopsy is also performed whenever graft dysfunction~     exists in the absence of an identifiable cause (infection, urinary graft obstruction).~   "
133423|NCT01820884|"~     This randomized trial is studying the efficacy and safety of the hysterectomy alone compared~     with hysterectomy and bilateral salpingo-oophorectomy (BSO) for patients with Stage IA~     endometrial carcinoma.~   "
133439|NCT01820663|"~     This phase 1 study tests whether use of the Modified Atkins Diet (MAD) can improve motor~     impairment after stroke. It is based on the hypothesis that after stroke, the brain's~     utilization of glucose, it's primary source of energy, is disrupted. The MAD is a~     low-carbohydrate diet that has can switch the body's metabolism from using glucose to using~     products of fat metabolism, so-called ketones. Ketones may act as an alternative energy~     substrate for the brain. Ketones also have several neuroprotective effects after stroke.~   "
133424|NCT01820871|"~     The purpose of this study is to evaluate the effectiveness of smartphone application for~     management of type 2 diabetes mellitus (DM).~      Type 2 DM is an almost incurable chronic disease and continuous management is important for~     long-term prognosis. However, patient's compliance to conventional medical intervention is~     generally unsatisfactory and many patients feel difficult to access to the detail medical~     advice for type 2 DM.~      Thus, the investigators developed a smartphone application for giving programed medical~     intervention to patients according to patients data; blood pressure, fasting blood sugar,~     body weight, calorie intake,exercise amount, etc.~   "
133425|NCT01820858|"~     This randomized trial is studying the efficacy and safety of the chemotherapy compared with~     radiation therapy alone as adjuvant treatment after operation in Patients with high risk and~     Stage I endometrial carcinoma.~   "
133426|NCT01820845|"~     Plethysmographic Variability index is a simple index accurate in predicting fluid~     responsiveness.~      The aim of this study was to investigate its accuracy in predicting fluid response to~     intravenous fluid challenge during scoliosis surgery in children.~   "
133427|NCT01820832|"~     The safety and efficacy of Caltriol on mild proteinuria (<1.0g/d) reduction in CKD patients.~   "
133428|NCT01820819|"~     The purpose of this study is to determine whether there are reasons other than medical~     reasons that could limit access to liver transplantation in alcoholic patients.~   "
133429|NCT01820806|"~     This will be a study in 6 healthy male subjects, each receiving a single oral dose of 100 mg~     [14C]-radiolabeled GLPG0634.~      The study aims to establish the elimination pathways of GLPG0634 and their relative~     significance and to assess the metabolite profile of GLPG0634 in plasma and in excreta.~      Furthermore, the pharmacokinetics (PK) of the main metabolites in plasma relative to GLPG0634~     will be evaluated.~      This study will also provide safety and tolerability information for GLPG0634.~   "
133430|NCT01820793|"~     Escherichia coli is the primary cause of urinary tract infections and Gram-negative~     bacteremia worldwide. Since the early years of the 21st century, E.coli has acquired a new~     mechanism of resistance to antibiotics: extended spectrum β-lactamase (ESBL), type CTX-M.~     These ESBL inactivate most β-lactams, the preferred class of antibiotics for the treatment of~     severe E.coli infections. Moreover, the strains that produce these ESBL are often resistant~     to other classes of antibiotics. Their rapid spread constitutes a major public health concern~     because of a serious risk of therapeutic impasse. Treatment options in cases of infection~     with ESBL-producing E.coli are often limited to carbapenems, a class of more recently~     developed β-lactams. Carbapenems have a very wide spectrum of activity but their~     effectiveness is threatened by the emergence of strains producing carbapenemases. The~     development of therapeutic alternatives to treat ESBL-producing E.coli infections is~     therefore essential. Cephamycins, including cefoxitin, are β-lactams marketed in the~     seventies but their use was practically abandoned when wide spectrum antibiotics became~     available. They are distinguished by the presence of an α-methoxy group in position 7 which~     interferes with the action of the extended-spectrum β-lactamase and renders it ineffective~     against cephamycins. Cefoxitin is therefore active in vitro against ESBL-producing E.coli and~     offers the advantage of a narrower antibacterial spectrum, thus reducing the selection~     pressure and the emergence of resistance. However, the in vivo activity of cefoxitin for the~     treatment of ESBL-producing E.coli infections has never been measured. Furthermore, available~     pharmacokinetic and pharmacodynamic (PK/PD) data for cefoxitin are dated and incomplete,~     which raises many questions concerning the optimal dosage regimen. We have shown in a mouse~     model of ESBL-producing E. coli CTX-M pyelonephritis that cefoxitin efficacy is comparable to~     that of carbapenems without selecting resistant mutants. Cefoxitin could thus constitute an~     alternative to carbapenems for the treatment of pyelonephritis caused by ESBL-producing~     E.coli.~   "
133431|NCT01820780|"~     After decompensated heart failure, a number of patients have high risk of early~     rehospitalization as well as death. Specialized medical management for a short period but~     very early after discharge could be critical for optimizing care and improving early outcome.~      This study aims to compare such early intensive medical management with usual care in~     high-risk patients after discharge.~   "
133432|NCT01820767|"~     Use of Paricalcitol in stage Vd Chronic Kidney Disease patients, over the effect of~     inflammatory and oxidative stress parameters.~   "
133433|NCT01820754|"~     The purpose of this study is to evaluate whether the combination of neoadjuvant chemotherapy~     (chemotherapy before surgery) plus ipilimumab for lung cancer increases the number of~     patients with detectable circulating T cells with specificities against tumor associated~     antigens (TAA) from zero percent (0%) of patients prior to therapy to 20% of patients after~     neoadjuvant chemotherapy plus ipilimumab.~      This is an open label Phase 2 trial. Patients with clinical stage 1B (>4 cm), 2, (N0-2) or 3~     non-small cell lung cancer (NSCLC) and no prior therapy for the current diagnosis of lung~     cancer will be eligible for the study. Subjects will receive 3 cycles of neoadjuvant~     chemotherapy (paclitaxel + cisplatin/carboplatin). Ipilimumab will be administered during~     Cycles 2 and 3 of standard chemotherapy and for up to 4 cycles alone after surgery. Subjects~     will undergo standard clinically indicated surgical resection of their lung cancer as deemed~     appropriate by their surgeon.~      Standard diagnostic and staging work up will be performed including: pathologic/histologic~     diagnosis of NSCLC, Positron Emission Tomography (PET)/Computed Tomography (CT) scan, brain~     imaging, and mediastinoscopy. Three cycles of neoadjuvant chemotherapy will be given.~     Ipilimumab will be added to neoadjuvant chemotherapy for cycles 2 and 3. Standard surgical~     evaluation and therapy will be performed following completion of neoadjuvant therapy. Two~     cycles of single agent ipilimumab will be given after surgery (adjuvantly), followed by 2~     cycles of maintenance therapy.~   "
133434|NCT01820728|"~     This is a phase III comparative study to evaluate the effectiveness and safety of DA-3801 in~     treatment of the patients with WHO Group II anovulatory infertility failing to clomiphene~     citrate treatment. The study is conducted with following methods: open label,~     active-controlled, randomized, parallel group, comparative.~   "
133435|NCT01820715|"~     A multi-centers, placebo-controlled, randomized, double-blinded, pilot clinical trial is~     designed to evaluate the safety of the DA-3030 injection and to explore the efficacy for~     Neuropathic pain.~   "
133436|NCT01820702|"~     Randomized cross-over design with 10 male subjects and 3 campaigns to test whether the~     negative effects of bed rest (6º head-down tilt) on the various systems of the body and the~     consequences to health of simulated weightlessness can be counteracted by the use of a~     defined training programme.~   "
133437|NCT01820689|"~     Purpose: Characterize the profile of tympanometric patients with cleft lip and palate in the~     post surgery period and correlate it with the time of palatoplasty. Methods: The sample~     consisted of 16 patients with cleft lip or palate totaling 32 ears treated at a Public~     University Hospital in Cuiabá (MT)- Brazil, in the post surgery moment that varied from three~     months to 33 years. Were sampled patients of both sexes, pediatrics and adults.~   "
133438|NCT01820676|"~     This study is designed to monitor long term clinical outcomes of the iUni G2+~     unicompartmental knee replacement~   "
133444|NCT01820598|"~     The study was designed to test the following hypotheses:~      In patients with severe obesity, a multisite electrostimulation session (m-NMES) will induce~     higher changes in metabolic, inflammatory and cardiovascular parameters and higher increase~     in muscle strength during stimulated contractions than conventional unidirectional~     electrostimulation session (c-NMES).~      In patients with severe obesity, a six-weeks m-NMES training program will enhance~     cardiovascular, metabolic and inflammatory parameters.~   "
133445|NCT01820585|"~     This was a double-blind, randomised, placebo-controlled, parallel-group, multicentre,~     multinational, Phase II study in 528 subjects with pain due to Fibromyalgia syndrome(FMS).~     Subjects were randomised in a 1:1:1:1 ratio to receive placebo, Eslicarbazepine acetate (ESL)~     400 mg once daily (QD), ESL 800 mg QD or ESL 1200 mg QD. The study was carried out as~     follows.~   "
133446|NCT01820572|"~     The primary purpose is to assess the benefits and risks of changing from Cyclosporine or~     Tacrolimus to Belatacept between 6-60 months after kidney transplant.~   "
133447|NCT01820559|"~     This was a multinational, randomised, double-blind, placebo-controlled, parallel-group study~     to evaluate the efficacy, safety, and tolerability of multiple doses of ESL as prophylactic~     treatment in subjects with migraine with or without aura. Subjects were randomised in a 1:1:1~     ratio to receive placebo, ESL 800 mg/day once daily (QD), or ESL 1200 mg/day QD.~   "
133448|NCT01820546|"~     In multiple myeloma cancer stem cells can be defined and quantified with flow cytometry.~     More, these cells can be related to treatment response.~   "
133449|NCT01820533|"~     To study ownership and use of cell phones in low-income smokers. This may help us better~     understand the impact of cell phone ownership plans on low income smokers' access to~     quitlines. Use of quitlines may be impeded by limited access to landline phones and limited~     airtime minutes on cell phones.~   "
133450|NCT01820520|"~     Study designed to evaluate the safety and efficacy of double staining with brilliant blue G~     0.025% as an adjuvant to macular surgery. Patients undergoing surgery for macular hole or~     epiretinal membrane will be included. Safety will be evaluated by optic coherence tomography,~     pattern reversal electroretinogram and multifocal electroretinogram.~   "
133451|NCT01820507|"~     Failure of extubation after mechanical ventilation is a frequent and deleterious issue. Main~     reasons for failure are hypoxemia, secretions retention, lung collapse and excessive work of~     breathing. Most of this issues can be partly counterbalanced by a device named High flow~     conditioned oxygen therapy (HFCO). Then, our hypothesis is that HFCO may reduce the~     incidence of respiratory failure after extubation in patients with high risk for failure.~   "
133452|NCT01820494|"~     The study objective is to assess the growth of infants fed an experimental formula for the~     nutritional management of chronic diarrhea.~   "
133453|NCT01820481|"~     This clinical trial is designed to evaluate the efficacy, dose-response and safety of~     WIN-901X in Asthma patients.~   "
133454|NCT01820468|"~     This randomized controlled study tests an adapted critical time intervention model for~     veterans discharged from a psychiatric inpatient unit. It is hypothesized that veterans on~     the inpatient unit who are assigned to such a community-based team will have shorter lengths~     of inpatient stay and better mental health. There have been few developments of~     community-based models of care in the post-deinstitutionalization era of short inpatient~     stays and the results of the study may inform how inpatient stays can be further reduced.~   "
133455|NCT01820455|"~     All trauma patients admitted to certain Intensive Care Units (ICU) will have~     Methicillin-resistant Staphylococcus aureus (MRSA) nasal swabs performed to determine MRSA~     colonization status. Only those patients who are determined to be colonized with MRSA at~     admission will be included in the study. All patients must be age 18 and older, admitted~     directly to the ICU from either the Emergency Department or the operating room with~     trauma-related injuries, and must not have active or recent known history of MRSA infections.~     Once patients have been determined to be colonized with MRSA, they will be randomized to~     receive decolonization treatment or placebo. Decolonization treatment will include~     Chlorhexidine baths and Mupirocin ointment to both nares for 5 days and placebo will entail~     routine soap baths and Lubricating Jelly. Both groups will be kept on standard contact~     precautions throughout the course of the study. Repeat nasal swabs will be performed at the~     completion of the treatment regimen to determine the efficacy. Patients will be screened for~     invasive MRSA infections as dictated by their clinical course. The primary outcome measure~     will be invasive MRSA infection rate (pneumonia, urinary tract infection, bacteremia and soft~     tissue infection). Secondary endpoints include hospital lengths of stay, ICU lengths of stay,~     mechanical ventilatory support requirements, colonization status at the end of treatment, and~     death rates. As determined by our power analysis, we aim to enroll 75 patients in each arm~     over the course of 12-24 months.~   "
133456|NCT01820442|"~     The primary objective of this study is to assess lofexidine related effects on QTc (an~     interval of the heart rhythm) in subjects receiving buprenorphine maintenance. The secondary~     objectives of the study are to evaluate the safety and tolerability of lofexidine by~     evaluating and monitoring pharmacokinetics (amounts of drug in the blood), vital signs (heart~     rate and blood pressure) and adverse events (side effects) when co-administered with~     buprenorphine; to describe effects on opiate withdrawal when lofexidine is introduced~     following a 50% buprenorphine dose reduction, as required to elicit a withdrawal response;~     and to evaluate QTc interaction effects of lofexidine compared with placebo. The~     Investigators hypothesize that while lofexidine is known to prolong the QTc interval, the~     combination of the drugs will not create an additive effect which creates a significant~     safety concern. The Investigators further hypothesize that subjects will be able to tolerate~     the therapeutic dose of lofexidine (0.8 mg four times daily) when the buprenorphine~     maintenance dose is lowered to elicit withdrawal.~   "
133457|NCT01820429|"~     The purpose of this study is to compare the response to aspirin in the acute phase with the~     late phase of an acute coronary syndrome.~   "
133496|NCT01819922|"~     This study is designed to assess the effect of one single dose of PF-05175157 on metabolic~     and cardiopulmonary parameters before, during and after treadmill exercise in healthy~     volunteers.~   "
133848|NCT01815346|"~     The goal of this clinical research study is to compare the level of effectiveness for 2~     acupuncture treatment schedules for chronic CIPN in breast cancer survivors. Researchers also~     want to study how patients may respond to acupuncture treatments, and how the treatments may~     affect quality of life, hand function, balance, and the use of drugs for neuropathy pain.~   "
133458|NCT01820416|"~     The purpose of this study is to determine whether low-level laser therapy can improve hearing~     thresholds in individuals with hearing loss. Subjects will be randomly assigned to a~     treatment, placebo, or control group. The treatment group will be given a three treatment of~     low-level laser therapy, which consists of shining low-level lasers beams onto the ear and~     head. The laser beams are cool to the touch, and do not cause discomfort. Each laser~     treatment will last approximately 4 minutes. Three treatments will be applied three times~     within the course of one week. Hearing tests will be administered immediately before~     treatment, immediately after treatment, and six weeks after treatment. Results will be~     analyzed to determine the effect of the laser treatment on hearing.~   "
133459|NCT01820403|"~     The study purpose was to evaluate the effects of portion sizes on body weight and energy~     intake in a free-living setting. 223 healthy adults were recruited from an urban worksite and~     randomized to one of four groups for a six-month period. The groups were: 1) 400 kcal box~     lunch; 2) 800 kcal box lunch; 3) 1600 kcal box lunch; or 4) no box lunch. Participants were~     required to pick up a box lunch every week day for six months. Control participants did not~     receive a box lunch and were instructed to eat their usual lunch. Participants were weighed~     and dietary intake measured at baseline, one, three and six months. It was hypothesized that~     at six months, participants in the 1600 kcal box lunch would gain more weight and have higher~     energy intake than those in the other groups.~   "
133460|NCT01820390|"~     Deep brain stimulation (DBS) has become the primary surgical therapy for the treatment of~     motor symptoms associated with Parkinson's disease (PD), and for essential tremor (ET).~     Although an effective and relatively safe procedure with expanding indications, opportunities~     exist for the optimization of the current procedure.~      The investigators therefore propose, in a group of patients undergoing DBS surgery for the~     treatment of PD or ET, to use a combination of high‐field imaging modalities, intraoperative~     electrophysiology, external sensor interfaces, and computational modeling, to gather~     information on the utility of using these techniques to optimize DBS electrode placement and~     programming.~   "
133461|NCT01820377|"~     Building on the successes of a communal, relationship based approach to Aboriginal youth~     mentoring in an after school physical activity program (AYMP), the investigators are~     evaluating a peer-led approach for diabetes prevention.~   "
133462|NCT01820364|"~     The primary purpose of the Phase II CLGX818X2102 study is to assess the anti-tumor activity~     of LGX818 in combination with selected agents.~   "
133463|NCT01820351|"~     The purpose of this study is to establish, through ultrasound, measurements of the thigh~     muscles (Biceps Femoris and Vastus Lateralis)and the chronic effects of a static stretching~     program on the muscle-tendon unit these muscles.~   "
133464|NCT01820338|"~     The Extension Family Lifestyle Intervention Project (E-FLIP for Kids) trial will evaluate the~     impact of a community based intervention delivered to families in rural settings utilizing~     the existing Cooperative Extension Service network on child dietary intake and weight.~     Specifically, the E-FLIP for Kids study will determine if behavioral treatments for child~     obesity lead to greater improvement in child weight compared to educational only~     treatment.Participants will include 240 parent-child dyads from ten rural counties in north~     central Florida. Study outcomes will be measure prior to treatment, at the end of treatment~     (month 12) and at one year follow-up (month 24). All treatment meetings will be held at~     Cooperative Extension Service offices within each participating county.~   "
133465|NCT01820325|"~     The Phase Ib part of the study aimed to determine the maximum tolerated dose/recommended~     Phase II dose (MTD/RP2D) of once daily buparlisib in combination with every-three-week~     carboplatin and paclitaxel in patients with previously untreated metastatic squamous NSCLC.~      The purpose of the Phase II portion of the study was to assess the treatment effect of adding~     buparlisib versus buparlisib-matching placebo to every-three-week carboplatin and paclitaxel~     on progression free survival (PFS) in patients with previously untreated metastatic squamous~     NSCLC.~   "
133466|NCT01820312|"~     The purpose of this study is to determine if low-dose radiation therapy and the chemotherapy~     drug paclitaxel is effective in treating head and neck cancer that has returned after~     treatment with standard radiation therapy alone, but cannot be removed by surgery. The~     overall total dose received of both the chemotherapy and radiation therapy will be less than~     that typically given as standard of care; however, the Food and Drug Administration (FDA) has~     not evaluated the safety and effectiveness of this combination therapy. In addition, this~     study will gather information about the effects of radiation therapy and chemotherapy on~     subject's overall quality of life.~   "
133467|NCT01820299|"~     This study is for subjects with solid cancers (gastrointestinal, lung, breast, prostate,~     lymphoma or cancer of the lymph nodes). The overall goal of this study is to identify~     plant-derived phytochemicals that can safely reduce systemic inflammation (inflammation~     throughout the entire body) in subjects with advanced cancer.~   "
133468|NCT01820286|"~     The investigators are doing this study to see if positive psychology can help adults with~     depression or bipolar disorder.~      Positive psychology involves exercises—short tasks—that try to increase good feelings and~     emotions, like optimism, happiness, personal strengths, and well-being. Positive psychology~     exercises might include imagining a bright future, being grateful for good events, forgiving~     others, and doing kind acts for others.~      The investigators want to see if practicing positive psychology exercises after leaving the~     hospital can increase feelings of hope, optimism, and positive thinking. The investigators~     are asking you to take part in this research study because you are in the hospital for~     depression or bipolar disorder.~      This research study will compare positive psychology exercises to control condition~     exercises. During the study, you may take part in control condition exercises instead of~     positive psychology exercises.~   "
133469|NCT01820273|"~     The purpose of this study is to determine the early changes in gut hormonal, and other~     metabolites with known relations to the glycemic homeostasis. The study mainly focus on these~     responses to food in the diabetic patient, compared to the non-diabetic, after gastric bypass~     surgery. Also aiming for recording changes in the earliest postoperative phase.~   "
133470|NCT01820260|"~     To identify the Maximum Tolerated Dose levels of ingenol mebutate gel after once daily~     treatment for 2 or 3 consecutive days and to evaluate efficacy of ingenol mebutate gel in~     different doses after once daily treatment for 2 or 3 consecutive days compared to vehicle~     gel~   "
133472|NCT01820234|"~     The purpose of this study is to determine the diagnostic and management concordance of~     face-to-face dermatologist versus a store-and-forward teledermatologist at a skin cancer~     screening event.~      The investigators' hypotheses include the following:~        1. Compared to in-person assessment, store-and-forward teledermatology assessment will~          result in adequate diagnostic concordance.~        2. Compared to in-person assessment, store-and-forward teledermatology results in adequate~          management concordance.~        3. The sensitivity and specificity of store-and-forward evaluation to detecting lesions~          that are either premalignant or malignant will be similar to that of in-person~          evaluation.~   "
133473|NCT01820221|"~     This is a randomized prospective clinical trial designed to determine the wound complication~     rates for stainless steel staples versus subcuticular suture for skin closure in the obese~     parturient (BMI≥ 30kg/m2) undergoing cesarean delivery.~   "
133474|NCT01820208|"~     After successful screening, first the investigators first treat patients of severe alcoholic~     hepatitis with steroids for 7 days. Patients who are found to be unresponsive as per Lille's~     score [>0.45] would be randomized into either placebo group or G-CSF group. Responders to~     steroids will continue on steroids for 28 days followed by 2 weeks of tapering. Non~     responders will be randomized to receive G-CSF for 28days.~   "
133475|NCT01820195|"~     There are many controversies about the role of N-Acetyl Cystein in preventing of contrast~     nephropathy. These contradictory results may be due to different criteria for patients'~     selection, different end points, different type and dose of N-Acetyl Cystein administration~     and finally different prophylactic measures other than N-Acetyl Cystein. The investigators~     try to enroll a double blind double dummy study with a good power to compare the effect of~     this drug both in the form of oral and intravenous against the placebo in preventing the~     contrast nephropathy in the patients whom undergo coronary angiography/angioplasty.~   "
133476|NCT01820182|"~     Comparative, randomized study patients are scheduled to have two capsule endoscopies within 2~     to 14 days from each other using two different endoscopies the Pillcam SB2 (Given Imaging,~     Israel) and the Capsocam (Capso Vision Saratoga United States) The order in which the devices~     are administered is randomly allocated.~   "
133477|NCT01820169|"~     This clinical study is to determine if the use of structured testing, which is a blood~     glucose monitoring, via the Accu-Chek 360° View blood glucose analysis tool has a positive~     effect on the subjects overall glycemic control.~   "
133478|NCT01820156|"~     Study Objectives: Obstructive sleep apnea (OSA) diagnosis using simplified methods such as~     home respiratory polygraphy (HRP) is only recommended in patients with a high pre-test~     probability. The aim is to determine the diagnostic efficacy, therapeutic decision-making and~     costs of OSA diagnosis using PSG or three consecutive studies of HRP in patients with~     mild-moderate suspicion of sleep apnea or with co-morbidity that can mask OSA symptoms.~      Design and Setting: Randomized, blinded, crossover study of three nights of HRP (3N-HRP) vs.~     PSG. The diagnostic efficacy was evaluated with ROC curves. Therapeutic decisions to assess~     concordance between the two different approaches were analyzed by sleep physicians and~     respiratory physicians (staff and residents) using agreement level and kappa coefficient. The~     costs of each diagnostic strategy were considered.~   "
133479|NCT01820143|"~     The objectives of this study were (a) to evaluate the pharmacokinetics and to evaluate and~     compare the pharmacodynamics of ilaprazole and esomeprazole following a single dose (Day 1)~     and once daily (QD) administration for 5 consecutive days each of 10-mg, 20-mg, and 40-mg~     ilaprazole tablets and 40-mg esomeprazole tablets; (b) to evaluate the safety of 10-mg,~     20-mg, and 40-mg ilaprazole tablets following QD oral administration for 5 consecutive days;~     and (c) to characterize the plasma gastrin concentration profile on Day 1 and Day 5 following~     QD oral administration of 10-mg, 20-mg, and 40-mg ilaprazole and 40-mg esomeprazole tablets~     for 5 consecutive days.~   "
133480|NCT01820130|"~     The purpose of this clinical investigation is to evaluate the safety and efficacy of Spinal~     Cord Stimulation (SCS) in advanced heart failure (HF) patients with Implantable Cardioverter~     Defibrillator (ICD) but not indicated for Cardiac Resynchronization Therapy (CRT).~   "
133481|NCT01820117|"~     While thoracic radiation therapy (TRT) has been a primary component in successful treatment~     of a variety of childhood and adult cancers, the exposure to this treatment has been~     associated with significant cardiovascular and pulmonary morbidity in long-term survivors.~     Within non-cancer populations, cardiovascular and pulmonary morbidity is associated with~     increased risk for cerebral vascular accidents (CVAs), accelerated brain atrophy and~     neurocognitive impairment. Patients with chronic heart disease demonstrate problems with~     attention, processing speed, memory, and executive functions. Chronic pulmonary disease also~     increases the risk of stroke, leukoencephalopathy, and neurocognitive impairment in~     non-cancer populations. The investigators propose to examine indices of brain integrity,~     including neurocognitive performance and brain MRI/MRA, in long-term adult survivors of~     Hodgkin lymphoma (HL) treated with thoracic radiation and no direct central nervous system~     therapy.~      OBJECTIVES:~        1. To evaluate brain integrity in adult survivors of childhood HL treated with thoracic~          radiation therapy.~        2. To identify therapeutic factors associated with brain integrity in adult survivors of~          childhood HL who are at risk for cardiac and pulmonary morbidity.~        3. To examine associations between cardiac, vascular and pulmonary health and brain~          integrity in adult survivors of childhood HL treated with thoracic radiation.~   "
133482|NCT01820104|"~     Oral hypoglycemic medications sometimes do not control type 2 diabetes well. Proton pump~     inhibitors (PPIs) as adjunctive therapy might improve diabetes control and could enhance the~     hypoglycemic activity of DPP4, but there is little clinical data on efficacy of this~     therapeutic strategy. The investigators sought to examine the effect of PPI lansoprazole,~     DPP-4 inhibitor sitagliptin, and their combination therapy on insulin and glucose regulation~     in healthy subjects in oral glucose tolerance (OGTT).~   "
133483|NCT01820091|"~     To determine the optimal dose and schedule of Fusilev to prevent or reduce Folotyn-related~     Grade 3 or higher oral mucositis in patients with Non-Small Cell Lung Cancer.~   "
133484|NCT01820078|"~     The purpose of this study is to estimate the differences between albuminuria values~     determined as Urine Albumin-to-Creatinine Ratio (UACR)(log transformed) from baseline to last~     observation caused by paricalcitol between the group of control and group of treatment.~   "
133485|NCT01820065|"~     Although contemporary cataract surgery has made tremendous strides in technological~     advancement, posterior capsular opacification (PCO) is still the most frequent long-term~     complication leading to decreased visual functions and thereby dissatisfying results. A great~     deal of effort has been made to develop new ways to prevent the formation of PCO. A key~     factor, widely discussed in literature, is the material and design of the intraocular lense~     (IOL) edge that can lead to PCO prevention. It is still not clear whether the sharp-edged IOL~     produces less PCO because of its optic geometry alone or whether the biomaterial contributes~     to the inhibition of PCO. With the clinical introduction of the single‐piece acrylic~     hydrophobic IOLs with some optic and haptic design differences compared with three‐piece~     acrylic hydrophobic IOLs, it has become possible to determine the influence of IOL material~     and design on PCO prevention. It is well established that the development of PCO is a dynamic~     process and that a longer follow-up time is correlated with a higher degree of PCO. So far,~     there have been prospective clinical studies on the clinical results of single and~     three‐piece acrylic hydrophobic foldable IOLs. However, the question as to as to whether the~     PCO further increases or becomes stable or regresses on a long-term basis has not yet been~     answered. Since there is paucity of available literature that prospectively evaluates the~     development of PCO with the implantation of the single-piece SN60AT hydrophobic acrylic IOL~     on a long-term basis, the investigators decided to observe the degree of development of PCO~     at 5 years after cataract surgery.~   "
133486|NCT01820052|"~     Fibromyalgia (FM) is a disorder with chronic widespread musculoskeletal pain for which no~     alternative cause can be identified. The condition is often accompanied by other features~     such as fatigue, stiffness, cold intolerance, cognitive impairment, intolerance to external~     stimuli, sleep disturbances, anxiety and depression, which significantly affect the quality~     of life. Fibromyalgia is characterized by altered pain perception, and studies have shown~     fibromyalgia to be more prevalent in patients with iron deficiency anemia. Iron is essential~     for a number of enzymes involved in serotonin and dopamine synthesis. Deficiency of~     serotonergic neuronal functioning might be related to the pathophysiology of FM.~      This study attempts to explore the use of oral iron as a cheap and readily available~     alternative for the treatment of FM .~   "
133487|NCT01820039|"~     Objectives The investigators present an online application to empower and inform patients and~     improve guideline adherence in unexplained subfertility. Thereby the investigators expect to~     reduce overtreatment in fertility care with higher quality of care.~      Methods The investigators conduct a prospective cohort study including couples with a~     diagnosis of unexplained subfertility. Couples consulting their general practitioner with an~     unfulfilled child wish will be offered to use FertiScreen. FertiScreen is an online~     application, in which patients are asked questions about their fertility problem (ie~     menstrual cycle, age, duration of child wish and the results of the Chlamydia Trachomatis~     antibody titre and semen analysis). FertiScreen then uses the validated prediction model of~     Hunault to calculate couples' chance of natural conception during the next twelve months. In~     addition, patients can find links to extra information concerning subfertility. Couples can~     then initiate an online consultation with their general practitioner and a gynaecologist, in~     order to discuss their results and prognosis. When the calculated prognosis of spontaneous~     conception within one year is >30%, tailored expectant management for 6-12 months will be~     advised, as no benefit can be expected from fertility treatment.~      Questionnaires will be sent to patients as well as to their caregivers (general practitioner,~     gynaecologist). These questionnaires will focus on the use of FertiScreen (System Usability~     Scale) and the different domains of quality of care (effectiveness, cost-effectiveness,~     safety, patient-centredness). For the latter, the investigators use the Hospital Anxiety and~     Depression Scale and the Patient Centredness Questionnaire for Infertility.~      In order to be able to draw conclusions, the investigators will conduct a baseline~     measurement among couples with unexplained subfertility who have been referred to a fertility~     clinic. Their data will be abstracted from their medical records and they will receive the~     aforementioned questionnaires as well (except for the System Usability Scale).~      The investigators will recruit couples presenting to general practitioners in the Nijmegen~     area (which for second line treatment consists of one general hospital and one academic~     hospital). To detect an increase in guideline adherence of the current 60% to 75% with a~     power of 80% (P<0,05), the investigators need to include 152 couples in the before as well as~     in the after measurement.~   "
133488|NCT01820026|"~     Bacterial infections are a frequent complication in liver cirrhosis with a bad prognosis.~     However, the clinical outcome of cirrhotic patients with serious infections is significantly~     improved over the last 30 years due to early diagnosis and to the use of a more appropriate~     antibiotic therapy.~      As in the general population, empirical treatment should be initiated soon after diagnosis,~     after making the necessary sampling and should be based on the use of an antibiotic with low~     toxicity and broad spectrum antibacterial efficacy, taking into account the local~     epidemiology and prevalence of antibiotic resistance.~      The third generation cephalosporins are considered the gold standard in the treatment of most~     infections in cirrhotics due to their effectiveness against enterobacteriaceae and against~     non-enterococcal streptococci and due to their low toxicity.~      However, the recommendations for the antibiotic therapy are currently based on results of~     trials of '80s and '90s, when the proportion of resistant pathogens was lower. Similarly to~     nosocomial infections, the increasing rate of infections due to multidrug resistant (MDR)~     bacteria represents the rational for a different choice of empirical antibiotic therapy with~     a higher resistance barrier. This change in the epidemiology of community acquired infections~     is mainly due to the increased contacts with healthcare system of these patients and for the~     larger use of antibiotic prophylaxis. With this regard, it was recently proposed to introduce~     a third epidemiological class of infection Health care-associated: Infections occurring in~     community in patients who have been in contact with the health system shortly before the~     infection.~      This epidemiological class of infection should be distinguished from community-acquired~     because they are more similar tonosocomial in terms of their sensitivity to antibiotics.~     Therefore for this class should be taken into consideration the use of a different empirical~     antibiotic therapy.~      The investigators aim was to evaluate prospectively the effectiveness of a broad spectrum~     antibiotic treatment in a cohort of cirrhotic patients with healthcare-Associatedinfections~      Cirrhotic patients with Healthcare Associated admitted to the gastroenterology department~     of the Policlinico Umberto I and in the Department of Hepatology of the Hospital of Marino~     will be consecutively enrolled.~      Randomized controlled trial with randomisation stratified by epidemiological class of~     infection.~   "
133489|NCT01820013|"~     This blinded randomized comparative trial aims to determine the effectiveness of a customized~     Dynamic Elastomeric Fabric Orthoses (DEFO) compared to a standard pelvic belt in: a) reducing~     pregnancy-related pelvic girdle pain (PGP), b) optimizing activity levels in pregnant women~     with PGP, c) improving quality of life for pregnant women with PGP d) cost effectiveness.~   "
133490|NCT01820000|"~     Use of MRI and DWI to diagnose cardiac scarring after heart attack.~   "
133491|NCT01819987|"~     About 17% of Chinese American preschool children are obese, compared to 12.4%of all children~     from age three to five years residing in the US; the prevalence of obesity is expected to~     increase in the future. Therefore, the proposed study will adapt a home-based and~     technology-centered childhood obesity prevention program for low-income Chinese American~     mothers of children three to five years old. The aims of the study are to assess the~     feasibility of the intervention and estimate the effect sizes on children's and mothers'~     outcomes.~   "
133492|NCT01819974|"~     The purpose of the study is to examine whether a stratified medication review performed in~     patients at highest risk of experiencing medication errors have impact on numbers of~     medication errrors during hospitalization.~   "
133493|NCT01819961|"~     The aim of this study is to assess the effect of postoperative parenteral fish oil on~     clinical outcome and immune function after major laparoscopic abdominal surgery.~   "
133494|NCT01819948|"~     The purpose of this study is to determine whether the administration of the PhytoMed™~     complement reduces CRP in women with histologically confirmed AJCC Stage 0-IIIA breast cancer~     which has been completely surgically resected and without evidence of disease as determined~     by their physician~   "
133497|NCT01819909|"~     There are very few level 1 or level 2 evidence studies that examine postoperative~     rehabilitation of rotator cuff repair and shoulder arthroplasty. A systematic review of level~     1 or level 2 evidence studies was performed (Baumgarten et al., Sports Health, 2009) that~     found only four studies that examined rotator cuff repair rehabilitation.~      The current study was performed to determine if there is a significant difference in passive~     glenohumeral joint range of motion, active glenohumeral joint range of motion, scapular~     substitution, and subjects measured outcome scores (clinimetrics) in patients who undergo~     rotator cuff repair when treated postoperatively with pulley exercises compared to Jackins'~     exercises.~      Null Hypothesis: There will be no significant difference in passive range of motion, active~     range of motion, scapular substitution, and subject measured outcomes scores in subjects who~     undergo rotator cuff repair when treated with pulley exercises compared to Jackins'~     exercises.~   "
133498|NCT01819896|"~     Over the past year smartphones have developed from a niche product to a commoditized product~     and are now squeezing classic mobile phones out of market. According to a survey a quarter of~     the German population is making use of a smartphone at present.~      An interference between smartphones and the functionality of pacemakers or implantable~     defibrillators is rather unlikely but cannot entirely be excluded. A systematic study~     regarding a possible interference between smartphones and modern pacemaker- and ICD-system~     with a better shielding against external influence has not taken place so far. In this study~     the investigators intend to investigate any interference between different smartphones~     produced by different manufacturers and diverse cardiovascular implanted electronic devices.~   "
133499|NCT01819883|"~     This study investigates fat distribution in people with acromegaly. The investigator is also~     investigating the change of fat distribution before and after treatment of acromegaly. The~     investigator will compare the results of people with acromegaly to the results of healthy~     volunteers.~   "
133500|NCT01819870|"~     The purpose of this study is to compare the pharmacokinetic characteristics and safety of~     dilatrend SR capsule 32mg and Dilatrend tablet 25mg in healthy male subjects.~   "
133501|NCT01819857|"~     For many years droperidol has been used in prophylaxis and therapy of PONV. Information that~     it can provoke disorders of cardiac ventricular rhythm reduced its popularity. However those~     data didn't base on solid examinations confirming torsadogenic action of droperidol. It is~     known that droperidol prolongs time of repolarisation, but there wasn't any data confirming~     its impact on transmural dispersion of repolarisation. Only estimation both of those actions~     in one time allows to define for sure arrhythmogenic role of droperidol.~      The aim of this study was to answer the questions:~      6. Does droperidol make an significant prolongation of heart repolarisation, expressed as~     corrected QT interval?~        1. Does droperidol cause increase of transmural dispersion of repolarisation?~        2. Does possible torsadogenic acting of droperidol depend on dose of drug?~        3. Does ondansetron cause changes of electrical heart function, suggesting its~          possibilities to induce TdP tachycardia?~        4. What is torsadogenic potential of droperidol and ondansetron used in prophylaxis PONV in~          people not suffering from cardiovascular diseases?~   "
133502|NCT01819844|"~     The purpose of this study is to test an experimental medical device designed to automatically~     control blood sugar. This device was designed for use by patients with diabetes while they~     are in the hospital, and others who may develop high blood sugar as a result of their medical~     problems.~   "
133503|NCT01819831|"~     When treated with surgery alone, many soft-tissue sarcomas have a high chance of coming back.~     Radiation therapy is frequently used in addition to surgery to reduce the chances of the~     sarcoma coming back. However, radiation can have long-term side effects on the normal tissues~     surrounding the tumor, leading to problems such as swelling, scarring, and joint stiffness.~      Recently, there have been advances in the way that radiation therapy can be given. Proton~     radiation therapy is one of those advances. With proton radiation, it is possible to give~     radiation over a smaller area surrounding the tumor, resulting in less radiation to the~     surrounding normal tissues.~      The purpose of this study is to determine whether proton radiation decreases the long-term~     side effects of radiation on normal tissues and if smaller proton radiation fields reduce~     local recurrence compared to the larger radiation fields that have been used in prior~     studies.~   "
133504|NCT01819818|"~     The purpose of this study is to evaluate the safety and tolerability of paliperidone~     palmitate over a 9-week period for participants with schizophrenia in Korea.~   "
133505|NCT01819805|"~     The purpose of this study is to evaluate the impact of extended release tramadol~     hydrochloride (75 mg) and acetaminophen (650 mg) tablets on improvement of pain.~   "
133506|NCT01819792|"~     Infectious morbidity and mortality is a major complication of AML (Acute Myeloid Leukemia)~     induction and consolidation chemotherapies related aplasia. The main aim of this study is to~     measure incidence of respiratory viral infections during AML induction and consolidation~     chemotherapy related aplasia. Primary end point is a positive polymerase chain~     reaction(PCR)associated with clinical signs.~   "
133507|NCT01819779|"~     The purpose of this study is to assess the pharmacokinetic characteristics of valsartan and~     S-amlodipine after single oral administration of Exforge tab. 10/160mg, a combination~     formulation of valsartan and amlodipine as reference drug and Lodivixx tab. 5/160mg, a~     combination formulation of valsartan and S-amlodipine as test drug in healthy male adults.~     Additionally the safety and tolerability of two drugs will be evaluated.~   "
133508|NCT01819766|"~     This study aims to determine the performance of the Exact IBD-ACRN surveillance test to~     detect colorectal cancer (CRC) and colorectal neoplasia in patients with inflammatory bowel~     disease (IBD). Patients with an IBD diagnosis for at least eight years or diagnosis of~     primary sclerosing cholangitis (PSC) and who are eligible for CRC screening are eligible to~     participate in this study. Enrolled subjects will collect a stool sample for the Exact~     IBD-ACRN surveillance test. Subjects must have undergone colonoscopy no more than 90 days~     prior to enrollment and will undergo colonoscopy or surgical intervention within 120 days of~     enrollment. Tissue diagnosis of CRC will be established by histopathologic examination.~   "
133552|NCT01819194|"~     This trial aims to establish a correlation between patient reported comfort while using soft~     contact lenses and meibomian gland dysfunction (MGD).~   "
133553|NCT01819181|"~     The study will evaluate all female patients with severe aortic stenosis undergoing~     transcatheter valve implantation with commercially available valves and delivery systems.~   "
133509|NCT01819753|"~     In this study 37 patients who had undergone percutaneous nephrolithotomy were included.~     Preoperative DMSA scans were performed a day before the surgery, whereas postoperative scans~     were randomized by evaluating them before (n=25) and after (n=12) the 6th postoperative~     month. A DMSA scan was read by using a technique that divides both kidneys into three paired~     poles. In this way functional changes were investigated in the renal units. Twenty six of 37~     cases underwent percutaneous nephrolithotomy with a single access site and 11 with multiple~     access sites. When each of the poles of a kidney was admitted as a surgical unit separately,~     there were 51 units.~   "
133510|NCT01819740|"~     The aim of our study is to determine if the levels of the HEM substance in seminal plasma~     are associated with the presence of prostate cancer in transrectal prostate biopsy.~   "
133511|NCT01819727|"~     The BMN 165 clinical development program has been designed to demonstrate the safety and~     efficacy of BMN 165 in reducing blood Phe concentrations in patients 18 to 70 years old with~     hyperphenylalaninemia due to PKU. Study BMN 165-301 is a Phase 3, open-label, randomized~     study designed to further characterize the safety of BMN 165 during two induction, titration,~     and maintenance dose regimens in adults with PKU who have not had previous exposure to BMN~     165 (naive). Subjects will be randomized (1:1) to titrate up to one of two dose regimens.~     Other key features of this study are the dose regimens chosen for induction and titration;~     the study duration; self administration of study drug; and the chosen tertiary objectives.~   "
133512|NCT01819714|"~     The main objective of this study is to evaluate the effect of 3 months of Snoezelen-type~     multi-sensory care sessions on NeuroPsychiatric Inventory Questionnaire (NPI-Q) scores for~     patients with Alzheimer's-type neurodegenerative disease.~   "
133513|NCT01819701|"~     Cardiovascular disease (CVD) is the leading cause of Taiwan. L-carnitine (LC) and coenzyme~     Q10 is recognized as lipid soluble antioxidants. The purposes of this study are going to~     investigate the relation of LC and coenzyme Q10 with the markers of lipid peroxidation,~     antioxidant enzymes activities, and the inflammatory markers in coronary artery disease (CAD)~     patients. The study is designed as a three-year study. The first year is an observation~     study. We will recruit CAD patients who are identified by cardiac catheterization as having~     at least 50% stenosis of one major coronary artery, and age-gender matched healthy subjects.~     The concentrations of LC, coenzyme Q10, lipid peroxidation markers (TBARS and ox-LDL),~     antioxidant enzymes activities (catalase, glutathione peroxidase, glutathione reductase, and~     superoxide dismutase), and inflammatory markers are going to analysis. The second year is a~     single-blind, single dose intervention study. CAD subjects are recruit form the first year~     and randomly assigned to placebo, coenzyme Q10-150 (150 mg/d), coenzyme Q10-300 (300 mg/d),~     LC-1000 (1000 mg/d) or LC-2000 (2000 mg/d) groups. Intervention is going to administration~     for three months. Fasting blood will be obtained in each month and determine the~     concentration of LC, coenzyme Q10, lipid peroxidation markers, antioxidant enzymes~     activities, and inflammatory markers after intervention. The third year is a single-blind,~     multiple doses intervention study. We are going to measure the CAD subjects from the second~     year intervention study. After three months washout period, the subjects are assigned to~     placebo, coenzyme Q10-150 plus LC-1000, coenzyme Q10-150 plus LC-2000, coenzyme Q10-300 plus~     LC-1000, and coenzyme Q10-300 plus LC-2000 groups. Intervention is going to administration~     for three months. Fasting blood will be obtained in each month and determine the~     concentration of LC, coenzyme Q10, lipid peroxidation markers, antioxidant enzymes~     activities, and inflammatory markers after intervention. Hopefully, the results of this study~     could provide information of LC and coenzyme Q10 supplementation for clinical dietitian in~     advising CAD patients.~   "
133514|NCT01819688|"~     The purpose of this study is to determine whether the postoperative insulin resistance and~     cytokine release would be attenuated in laparoscopic compared with open liver resection.~   "
133515|NCT01819675|"~     The purpose of this study is to determine whether repetitive transcranial magnetic~     stimulation (rTMS) over the brain can modulate the binding of neurotransmitter (GABA in this~     study) to its receptor using the special PET study.~   "
133516|NCT01819662|"~     Permanent pacemakers are a common treatment for slow heart beats. In the UK 300,000 people~     have a pacemaker, and each year another 36,000 receive them. All of these patients are~     usually seen yearly to have their device checked. However, pacemaker technology is now very~     reliable, batteries last well over 5 years, and many patients require their pacemaker only~     occasionally as a back-up. Each visit costs around £200 such that pacemaker follow-up cost~     the NHS around £50million per year. Most visits involve checking the battery and the leads~     which, in the absence of symptoms might be unnecessary.~      Pacemaker patients are at risk of developing other problems including heart failure which~     puts them at higher risk of hospitalisation and death. For those under follow-up, no~     mechanism exists to identify whether they might have heart failure, and for those receiving~     new implants, it is unclear which will go on to develop heart failure. Also, whether optimal~     heart failure treatment with a multidisciplinary team reduces the chances that they will be~     hospitalised is also unproven.~      Our study therefore has three main aims: 1) based on pacing indications and patient factors,~     to identify which patients are likely to develop complications and therefore which patients~     could be seen less frequently; 2) to validate and refine a simple risk score to help identify~     which patients in pacing clinic should undergo screening for heart failure; and 3) to~     establish whether such screening and subsequent optimisation of those with heart failure is~     clinically and cost-effective for reducing hospitalisation and death.~   "
133517|NCT01819649|"~     This is a pilot study proceeding an intended international trial.~      Hypothesis: Daily intake of selenium supplementation in the form of selenium-enriched yeast~     tablets will reduce the risk of cancer in healthy individuals.~      Objective: The objective of this pilot study was to assess the viability of a full scale~     randomised trial.~      AMENDMENT TO STUDY OBJECTIVE: Mortality analysis during intervention and follow-up as~     specified in the sections concerning study design and outcome measures.~   "
133518|NCT01819636|"~     The aim of the study is to assess the beneficial effect of the short term consumption of the~     highly mineralized bicarbonated sodium water on blood lipid parameters compared to a low~     mineralized water.~   "
133519|NCT01819623|"~     Supervised nonpharmacologic therapy improve cognitive function in patients with Mild~     Cognitive Impairment~   "
133520|NCT01819610|"~     A SPRIX trial in pediatric subjects vs. adults undergoing open surgical procedures resulting~     in at least a moderate pain level. Subjects will receive SPRIX and blood samples will be~     collected for pharmacokinetic (PK) assessment. Subjects will also be assessed on the safety~     and efficacy of SPRIX.~   "
133554|NCT01819168|"~     The aim of this retrospective study is to analyze if nighttime antimuscarincs may be more~     effective in treating patients with nocturia.~   "
133555|NCT01819155|"~     This study will provide the Senegal Ministry of Health with data on the safety and~     immunogenicity of adjuvanted trivalent inactivated influenza vaccine (adjTIV) and full-dose~     seasonal non-adjuvanted trivalent inactivated influenza vaccine (TIV) in children. This data~     will inform future policy considerations for influenza vaccine. The study is not powered to~     detect significant differences between vaccines or groups, and no hypotheses are to be~     tested; therefore, immunogenicity and safety objectives are to be analyzed descriptively.~   "
133521|NCT01819597|"~     Stroke due to intracranial arterial atherosclerosis is a significant medical problem,~     carrying one of the highest rates of recurrent stroke despite best medical therapy, with~     annual recurrence rates as elevated as 25% in high risk groups.~      The goal of this investigation is to advance a promising surgical treatment for symptomatic~     atherosclerotic intracranial stenosis - encephaloduroarteriosynangiosis (EDAS). The~     investigation will test in a phase II futility trial the potential of EDAS for further~     development before proceeding with the design of a definitive clinical trial of EDAS~     Revascularization in patients with Symptomatic Intracranial Arterial Stenosis (ERSIAS).~      The investigation is a 4-year futility trial to test the hypothesis that EDAS~     revascularization combined with aggressive medical therapy warrants further evaluation in a~     subsequent pivotal trial as an alternative to aggressive medical management alone for~     preventing the primary endpoint of stroke or death in patients with symptomatic intracranial~     arterial stenosis (Specific Aim 1). During the investigation the time course of~     collateralogenesis and perfusion improvement following EDAS will also be evaluated (Specific~     Aim 2.~   "
133522|NCT01819584|"~     The purpose of this study is to continue follow up of conservatively treated CHI patients and~     to focus on their metabolic outcome, including frequency of hypoglycemia after discontinuing~     treatment and incidence of diabetes mellitus in the long term.~   "
133523|NCT01819571|"~     The investigators hypothesized that predictability of pulse pressure variation (PPV) on fluid~     responsiveness would be reduced in patients with coronary disease who have diastolic~     dysfunction.~   "
133524|NCT01819558|"~     Patients with acute or chronic myeloid leukemia, or myelodysplastic syndrome, underwent~     allogeneic stem cell transplantation from HLA-identical donor (related or unrelated) after~     reduced-intensity conditioning regimen.~      If WT1 expression is detectable on tumor cells, they will receive an immune therapy 60 days~     after allograft.~      6 administrations every 2 weeks of the protein recwt1-A10+AS01B will be administrated.~      The safety and immunological efficacy of this immune therapy after hematopoietic stem cells~     transplantation with reduced intensity conditioning will be evaluated.~   "
133525|NCT01819545|"~     The miRNA 107 gene is increasingly appreciated to serve key functions in humans. The miRNA~     regulate gene expression involved in cell division, metabolism, stress response, and~     angiogenesis in vertebrate species. But the relationship and diagnosis capability of miRNA~     107 and BACE1 mRNA gene expression in plasma and cerebrospinal fluid (CSF) of amnestic mild~     cognitive impairment (aMCI) and normal control is still a mystery.~   "
133526|NCT01819532|"~     Anemia in preterm neonates is a significant problem encountered frequently in the neonatal~     intensive care unit. Most preterm neonates born at less than 33 weeks gestation will require~     at least one blood transfusion during their hospital course and many will require repeated~     transfusions. Blood transfusions, albeit necessary, carry increased risk of viral infections~     and transfusion reactions as well as increase the cost of healthcare. The umbilical cord and~     placenta harbor up to 40% of blood available during fetal life. The current standard of care~     is immediate umbilical cord clamping. The investigators are performing a randomized~     controlled trial comparing immediate cord clamping to milking the umbilical cord prior to~     clamping in neonate born preterm less than 33 weeks gestation. The investigators hypothesize~     that milking the umbilical cord will demonstrate the same benefits as delayed cord clamping,~     without delaying neonatal resuscitation.~   "
133527|NCT01819519|"~     The purpose of this study is to develop a brief screening and behavioral intervention for the~     prevention of congenital cytomegalovirus (CMV) that will both be acceptable to clinic staff~     and feasible to implement as part of routine clinical prenatal care, and to test whether~     behavioral intervention for susceptible pregnant women can lead to a behavioral change that~     is likely to lead to decreased primary CMV infection. The study research assistants will~     enroll pregnant women who are less than 20 weeks' gestation, either English or~     Spanish-speaking and that do not have a primary CMV infection (never been infected or~     previously infected). Enrollment will occur during the woman's prenatal visit.~   "
133528|NCT01819506|"~     Each year in the US, approximately 795,000 people have a stroke, and the overwhelming~     majority of those who survive are unable to resume meaningful daily activities because of~     impaired movement in one arm/hand. This study will investigate the effects of a challenging~     4-week physical rehabilitation therapy program that is targeted at specific movement~     impairments and systematically progressed to assure an ongoing just right level of rigor.~     The investigators anticipate that therapy targeted to address specific movement impairments~     will improve recovery of arm/hand movement in people who have had a stroke.~   "
133529|NCT01819493|"~     In response to the growing threat of obesity on the health of American children, specifically~     African American children, the investigators propose to develop a program to educate and~     motivate African American families to improve health behavior for obesity reduction and~     diabetes prevention. This project will be unique in its partnership with local YMCAs and its~     use of Family Health Coaches from the YMCAs who will work one-on-one with participating~     families. The investigators feel this program will benefit all members of the families who~     are enrolled and will encourage all members to participate though the study will target one~     parent and one child who is 8 to 10 years old.~   "
133530|NCT01819480|"~     The purpose of this study is to learn more about the outcomes of treatment of throat and~     voice box cancers using transoral robotic surgery (TORS). TORS is a relatively new option~     involving the use of the da Vinci surgical robot to remove these cancers through the mouth.~   "
133531|NCT01819467|"~     The primary objective of this study is to determine whether the use of Seprafilm reduces the~     incidence rate of adhesion formation following a primary C-section.~      A secondary objective of the study will be to determine whether or not a correlation between~     the adhesion score and the difficulty or delay in delivery of the infant exists.~   "
133556|NCT01819142|"~     The aim of this trial is to demonstrate the effectiveness of complete wound healing in a~     prospective, open-label, case-matched cohort-controlled trial in which pressure ulcers will~     be treated using AutoloGel and standard care and case-matched against a concurrent cohort of~     patients receiving undefined Usual and Customary Care.~   "
133557|NCT01819129|"~     This trial is conducted in Asia, Europe and North America. The aim of the trial is to compare~     FIAsp (faster-acting insulin aspart) to insulin aspart, both in combination with insulin~     glargine and metformin in adults with type 2 diabetes.~   "
133532|NCT01819454|"~     The aim of the project is to define the frequency with which EER is present in patient with~     chronic rhinosinusitis (CHR). The measurement will be carried out with a 24-hour monitoring~     of the pH using the Restech system. This modern device is equipped with a narrow antimony~     probe. The sensor is able to record not only liquid but also aerosol reflux episodes. The~     second aim is to determine the relation among EER, CHR and asthma bronchiale. We will compare~     the presence of reflux in three different patient groups (1. CHR without nasal polyposis,~     without asthma bronchiale or ASA syndrome, 2. CHR with nasal polyposis, without asthma~     bronchiale or ASA syndrome, 3. CHR with nasal polyposis and asthma bronchiale and/or ASA~     syndrome). We expect to find a significantly more frequent presence of EER in patients with~     CHR and asthma bronchiale or ASA syndrome. In case our hypothesis is confirmed, it will be~     especially these patients(with a difficult to manage nasal polyposis) benefiting from the~     antireflux therapy.~   "
133533|NCT01819441|"~     A. the controlling of the blood pressure, especially the variation of blood pressure, can~     slow down the development of the small vessel disease.~      B intensive BP control is more effective than normal control of blood pressure in slowing~     down the small vessel disease.~      C drugs of Calcium Channel Blocker(CCB) and Angiotensin-Converting Enzyme Inhibitor(ACEI)~     have no significant difference in lowing the blood pressure and variability of blood pressure~   "
133534|NCT01819428|"~     The purpose of this open-label, single-arm, multi-center phase II trial is to evaluate the~     efficacy and safety of novel pan-HER inhibitor, NOV120101 (Poziotinib), as a first-line~     monotherapeutic agent in patients with lung adenocarcinoma harboring EGFR mutation.~   "
133535|NCT01819415|"~     The purpose of this trial is to detect the influence of omega-3 supplements on vitreous~     levels of vascular endothelial growth factor (VEGF) in exudative age-related macular~     degeneration (AMD) in patients receiving intravitreal anti-VEGF treatment. Patients are~     randomized to receive either Age-Related Eye Disease Study 1(AREDS-1) supplements formula~     with the addition of Lutein or AREDS-2 supplementation that adds Omega-3 metabolites (DHA and~     EPA) to the formula. Our goal is to take a limited volume of vitreous sample from these~     patients previous to their regular anti-VEGF injection and perform a comprehensive cytokines~     and lipidomic profiling. We hypothesize, based on our previous basic science discovery of a~     potent anti-VEGF action of an Omega-3 metabolite (4-HDHA), that lipid metabolite composition~     and metobolite levels will significantly vary according to VEGF levels. Based on the results~     of this pioneering clinical study, our research team will proceed to evaluate the individual~     anti-angiogenic (vessel growth stopping) properties of the predominant Omega-3 metabolites~     found.~   "
133536|NCT01819402|"~     Excess visceral fat is associated with chronic systemic inflammation and cardiovascular~     complications. Pioglitazone has been reported to variably influence visceral fat volume, but~     it its effect on metabolic activity of the visceral fat remains uncharacterized. To evaluate~     the effect of pioglitazone on glucose metabolism of fat tissue by using~     18F-fluorodeoxyglucose (FDG)-positron emission tomography (PET) and computed tomography (CT)~     imaging.~   "
133537|NCT01819389|"~     The purpose of this study is to determine if low-dose imatinib and nilotinib combination,~     will improve treatment results in CML patients with failure, suboptimal response or~     intolerance to imatinib therapy.~      The hypothesis is that with low-dose imatinib and nilotinib combination, major molecular~     response will be achieved in patients not previously obtained with imatinib monotherapy.~   "
133538|NCT01819376|"~     The purpose of this study is to determine if Facebook can be used as a motivating factor for~     obese or overweight adolescents in a weight-reduction program.~   "
133539|NCT01819363|"~     The objective of this study is to analyze the correlation between pleural elastance and the~     radiological effectiveness (measured by chest tomography) of pleurodesis performed via~     catheters in patients with RMPE. The secondary objectives of this study are: correlate~     pleural elastance with quality of life, analysis of dyspnea and pain after the procedure,~     clinical effectiveness, complications and mortality in 30 days.~   "
133540|NCT01819350|"~     The aims of this study were to determine the sucrose and liquid oral pediatric medicines of~     long-term effect on dental biofilm pH to evaluate the cariogenic potential in vivo.~   "
133541|NCT01819337|"~     The aim of this study is to identify if there exists a correlation between the preoperative~     cardiopulmonary capacity - measured in MET's - and the perioperative lactate serum level.~   "
133542|NCT01819324|"~     1. The purpose of the study is to test the effectiveness of a new mail-based intervention~          for breast cancer survivors compared with standard lifestyle management and~          no-treatment.~        2. This intervention addresses both lifestyle factors such as dietary and physical~          activities and psychological issues specific to breast cancer survivors to improve~          healthy behaviors.~   "
133543|NCT01819311|"~     This project will test Attention Bias Modification Training (ABMT) among children and~     adolescents who have completed a full protocol of cognitive behavior therapy (CBT) for~     anxiety and still meet criteria for a primary diagnosis of an anxiety disorder. The purpose~     of this project is to determine whether ABMT leads to reductions in anxiety and related~     impairment, relative to a placebo task condition.~   "
133558|NCT01819116|"~     The objective of this study is to quantify the association between tissue oxygen saturation~     (StO2) during the donor management phase of the Death by Neurological Criteria (DNC) organ~     donor and the number of organs transplanted per donor.~   "
133559|NCT01819103|"~     To investigate the causes of hospital variation in outcomes from acute coronary syndromes in~     England and develop recommendations for improving patient care.~   "
133560|NCT01819090|"~     Mechanical ventilation is one of the only treatment that has improved survival of patients~     with neuromuscular respiratory failure. As disease progresses, some patients may require~     longer ventilation period. Non invasive mechanical ventilation is the preferred method of~     ventilation but it may interfere with speech and communication of patients who require~     ventilation throughout the day. The investigators are evaluating the effect on speech and~     communication of a ventilation device which allows patients to momentarily and voluntarily~     withhold ventilation if they want to speak. This should allow the patients to have a more~     fluid speech.~   "
133884|NCT01814852|"~     This is a prospective, randomized, double-blind clinical study for assessing the safety and~     efficacy of the treatments performed with Renova (LI-ESWT) on symptomatic ED patients.~   "
133544|NCT01819298|"~     Patients with COPD (chronic obstructive pulmonary disease) suffer from episodes of acute~     exacerbations leading to additional morbidity and mortality, and also a further decline in~     lung function. It has been well-established that bacterial colonization is prevalent in COPD,~     especially in moderate to severe COPD, and airway bacterial colonization is known to play an~     important role in the development of pneumonia and exacerbations. On the other way, inhaled~     corticosteroid (ICS) and long acting β2 agonist (LABA) were recommended in the treatment of~     moderate to severe COPD. Though there were some evidences that ICS had some protective~     effects on airway mucosa against bacteria invasion, the locally immunosuppressive effects of~     ICS is still a concern. Indeed, the incidence of pneumonia was higher than the control group,~     not only in the Towards a Revolution in COPD Health (TORCH) study but also in various studies~     and meta-analyses.We hypothesized that airway bacteria colonization is associated with~     disease severity, and that disease status can be identified by CAT (COPD assessment~     test)scores and changes of CAT scores. We therefore conducted this prospective, observational~     study in which CAT scores and sputum cultures were assessed in moderate to severe COPD~     patients with the combination therapy of ICS and LABA every three months during the study~     period. The primary end-point is the condition of potential pathogenic microorganisms (PPM)~     colonization in view of CAT scores. The second end-point was the changes of PPM colonization~     in association with CAT changes during follow-up. By the mean of CAT follow-up, it could~     possibly provide a surrogate about the risk of exacerbation and pneumonia under the~     combination therapy of ICS and LABA.~   "
133545|NCT01819285|"~     Objectives~      I. Compare, in a randomized Phase III multi-institutional setting, symptom-free survival time~     of patients with asymptomatic carcinoma of the prostate (T0-4, N0-2, M0) not suited for local~     curative treatment who are randomly assigned to immediate vs. delayed endocrine intervention~     (orchiectomy or luteinizing hormone releasing hormone (LHRH) agonist therapy).~      II. Compare the overall survival of these two groups of patients.~      III. Compare the time to first evidence of distant progression (N4 or M1) of these two~     treatment groups.~      IV. Evaluate the prognostic significance of pretreatment laboratory data and monitor these~     parameters following endocrine therapy.~      V. Study the prognosis of various sub-groups of patients stratified according to performance~     status, local tumor extent, nodal status, and choice of endocrine treatment.~   "
133546|NCT01819272|"~     This study compared the effect of delayed-release metformin (Met DR) to placebo and extended~     release metformin (Met XR) on glycemic control (fasting plasma glucose and HbA1c) and body~     weight, and assessed the safety and tolerability of a range of doses of Met DR when~     administered in subjects with type 2 diabetes mellitus (T2DM).~   "
133547|NCT01819259|"~     The overall goal of the proposed research is to evaluate the behavioral and genetic~     mechanisms of smoking risk in non-smoking young adults (aged 18-25 years of age) with and~     without ADHD using a novel laboratory-based model of intranasal nicotine administration.~      Study Hypotheses:~        1. that nicotine will produce greater positive and fewer negative/aversive subjective~          effects in individuals with ADHD. The study team also hypothesizes that nicotine will~          improve performance to a greater degree in those with ADHD.~        2. that individuals in the ADHD group will exhibit an increase in choices for nicotine vs.~          placebo in both conditions (i.e., main effect) and that this effect will be more~          pronounced in the High Demand vs. Low Demand conditions (i.e. Group x Condition~          interaction). Also that greater performance enhancing effects of nicotine will be~          associated with greater nicotine choice during the high demand cognitive condition.~        3. that the main effects of ADHD status on nicotine reinforcement will be heightened in the~          presence of certain genotypes. Also that the main effects of ADHD status on nicotine~          reinforcement will be heightened in the presence of certain genotypes. Finally that~          exposure to nicotine will alter epigenetic patterns in DNA~   "
133548|NCT01819246|"~     The overall aim is to reduce overall allogeneic transfusion requirements during cardiac~     surgery when compared to standard management.~      To evaluate this the investigators will test the hypothesis that intraoperative, autologous~     platelet apheresis will primarily avoid allogeneic platelet transfusion. Following induction~     of anesthesia and intravascular line insertion, the patient will be randomized to control or~     treatment arms by sealed envelope technique where computer generated, randomization numbers~     are assigned prior to enrollment based on study patient number which is never reused.~      The control arm will have central venous access sham connected to the apheresis machine~     Trima® (Terumo BCT, Denver CO); the treatment arm will be connected and undergo pheresis. The~     clinical team will be blinded by a sterile sheet acting as a curtain and a recorded playback~     of the typical sounds of the operation of the apheresis machine. At the end of the pheresis,~     the platelet units will be disguised with opaque coverings and agitated at room temperature~     in compliance with the American Association of Blood Banks (AABB) recommendations for~     platelet storage. On separation from CPB, the blinded administration of autologous platelets~     or allogeneic (blood bank) platelets will occur after protamine administration, if the~     surgeon requests platelet transfusion (this is typically the case for these operations). The~     surgeon will be blinded and he will order subsequent transfusions based on clinical evidence~     of microvascular bleeding in accordance with standard guidelines, as is the investigators~     practice for these operations.~   "
133549|NCT01819233|"~     This pilot clinical trial studies caloric restriction in patients with stage 0-I breast~     cancer during surgery and radiation therapy. Reducing caloric intake may prevent disease~     progression in patients with breast cancer. Radiation therapy uses high energy x rays to kill~     tumor cells. Giving dietary intervention and radiation therapy together may kill more tumor~     cells.~   "
133550|NCT01819220|"~     Recent studies have demonstrated that RAS inhibitors/calcium channel blockers are superior to~     RAS inhibitors/diuretics for reducing cardiovascular outcomes in hypertension. As such, RAS~     inhibitors/calcium channel blockers are recommended as first line combination treatment for~     hypertension. However, the mechanism for the superior efficacy of RAS inhibitors/calcium~     channel blockers are not well defined. This study will compare the efficacy of RAS~     inhibitors/calcium channel blockers vs RAS inhibitors/diuretics in terms of glucose tolerance~     and insulin resistance in hypertensive patients with metabolic syndrome. The primary endpoint~     will be that RAS inhibitors/calcium channel blockers will be more efficacious in reducing~     2hour post prandial glucose compared to RAS inhibitors/diuretics.~   "
133551|NCT01819207|"~     thromboelastography can identify alteration in the coagulation profile in bariatric patients~     who undergo sleeve gastrectomy or gastric bypass~   "
133561|NCT01819077|"~     TMMR/tLNE was shown to result in very low locoregional recurrence rates and low morbidity in~     surgical treatment of cervical cancer stage IB-IIA without any adjuvant radiotherapy even in~     high risk situations. More and more this therapeutic strategy is implemented in clinical~     routine in specialized cancer centres, thus, treatment of cervical cancer could be performed~     for these stages in a systematically defined and reproducible radicality; adjuvant~     radiotherapy could be spared for recurrent disease, thus lowering morbidity and resource~     assignment in primary treatment dramatically. Due to the nerve-sparing character of the~     procedure bladder, bowel and sexual dysfunction would also be minimized and markedly benefit~     the patient.~      This study is designed to follow up the results of this therapeutic concept adapted to~     clinical routine in a multiinstitutional register study accompanied by detailed assessment of~     pathological work-up, quality of life and bladder and sexual function following surgery.~   "
133562|NCT01819064|"~     An infants heart rate is very important because it ensures that blood is pumped to all organs~     in the body. Heart rate may decrease during anesthesia and surgery, and this is why the~     anesthesiologist will often give a medication to prevent this from happening. The most common~     drug for this purpose is called atropine. The dose of most drugs given to babies is based~     upon the baby's weight, but some believe that the dose of atropine should not be less than~     0.1mg. However there is no evidence to support this minimum dose. A larger dose of atropine~     may cause a very fast heart rate instead. Anesthesiologists routinely dose the atropine based~     upon the baby's weight without regard for a minimum dose.~      The purpose of the present study is to measure the heart rate after doses of atropine in~     neonates and infants who receive less than 0.1 mg.~   "
133563|NCT01819051|"~     The purpose of this study is to evaluate the safety of treating human toenails with~     atmospheric plasma (MOE Antimicrobial Plasma Treatment System) and get an initial evaluation~     of the efficacy of this treatment for toenail fungus (onychomycosis).~   "
133564|NCT01819038|"~     This research project is a prospective study to compare mortality between early renal~     replacement therapy (RRT) and late renal replacement therapy by using plasma neutrophil~     gelatinase associated lipocalin (pNGAL) as a tool in decision- making.~   "
133565|NCT01819025|"~     The purpose of this study is to investigate whether face-to-face Cognitive Behavioral Therapy~     (CBT) with a smartphone application, focused on providing support in homework assignments and~     an increase in behavioral activation, is effective in treating mild to moderate depression.~     The study will be conducted as a randomized controlled treatment study investigating the~     effect of the current blended treatment compared to treatment as usual.~   "
133566|NCT01819012|"~     The purpose of this study is to determine Isoflurane's dose-dependent effect on left~     ventricular (LV) systolic function in cardiac surgery. The change of tissue Doppler imaging~     (TDI) of lateral mitral valve annular systolic velocity at three different isoflurane~     concentrations would be analyzed by using intraoperative transesophageal echocardiography~     (TEE) in cardiac surgery patients.~   "
133567|NCT01818999|"~     This study is being done to find the effect of Stereotactic body radiation therapy (SBRT) in~     combination with Ixabepilone for women with triple negative metastatic breast cancer.~   "
133568|NCT01818986|"~     In this i-SABR (immunotherapy + Stereotactic Ablative Body Radiation) trial, the stereotactic~     radiation to multiple metastatic sites is delivered not only to eradicate sites of bulky~     progressive disease, but also to provide antigen presentation and immune stimulation which is~     expected to act synergistically to the concurrently administered immunotherapy Sipuleucel-T~     and thereby significantly improve the treatment outcome for metastatic castrate resistant~     prostate cancer patients (mCRPC). Both Sipuleucel-T and SABR are FDA approved therapeutic~     cancer treatment~   "
133569|NCT01818973|"~     We presumed that the addition of a monoclonal antibody Bevacizumab into radiation therapy and~     combination chemotherapy could results in improved pathologic tumor regression grade (TRG) in~     locally advanced nonmetastatic rectal cancer.~   "
133570|NCT01818960|"~     Revascularization strategies for ST elevation myocardial infarction (STEMI) study~     (ASSIST-CMR) will compare the effects of two revascularization strategies [same sitting~     multivessel primary PCI (SS-PCI) and culprit vessel only primary PCI (IRA-PCI)] on myocardial~     infarct size (MIS) as determined by cardiac magnetic resonance (CMR) imaging in patients~     presenting with STEMI and multivessel disease (MVD).~   "
133571|NCT01818947|"~     The purpose of this study is to understand real world gefitinib usage patterns, patient~     characteristics and outcomes and to present these for a Caucasian population~   "
133572|NCT01818934|"~     The aim of the randomized controlled trial was to determine whether the addition of a general~     or of a selective ultrasound screening program resulted in more appropriate criteria for~     treatment and a reduced prevalence of late DDH compared with clinical examination alone.~   "
133573|NCT01818921|"~     The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics for~     certain doses of beloranib in obese subjects with Prader-Willi Syndrome.~   "
133574|NCT01818908|"~     The major purpose of this clinical study is to assess clinical outcome of dose-adjusted EPOCH~     regimen for patients with non-Hodgkin's lymphoma(NHL)-associated hemophagocytic~     lymphohistiocytosis~   "
133575|NCT01818895|"~     The purpose of the study is to assess the dying process in critically ill patients with~     decision to withdraw invasive mechanical ventilation in anticipation of death and to compare~     effects of extubation and those of terminal weaning of mechanical ventilation on relatives~     and care givers. The investigators primary hypothesis is that extubation is associated with~     less symptoms of post-traumatic stress disorders in relatives, as compared to terminal~     weaning.~   "
133576|NCT01818882|"~     The main objective of our study is to compare the effects of two care strategies for dyspneic~     patients on the length of hospital stay: (1) standard care (=contextual analysis +~     conventional clinical chest radiography) versus (2) standard care + pleuropulmonary~     ultrasound.~   "
133577|NCT01818869|"~     This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics~     of multiple ascending doses of AZD8848 in healthy subjects.~   "
133578|NCT01818856|"~     Hypothesis: the Telaprevir(TVR) plasma levels (750 mg q8h or 1125 mg/12h )will not be~     affected when co-administered with un-boosted Atazanavir (ATV) 200 mg q12h plus two analogues~     (NRTIs) in HCV/HIV-co-infected patients.~   "
133580|NCT01818830|"~     The patients with sepsis are in the state of hypermetabolism, increased resting energy~     expenditure, protein and fat catabolism disorder, negative nitrogen balance, insulin~     resistance, hyperglycemia, and amino acid metabolism disorders. However, it is remain unclear~     the changes of amino acids expression profiling in sepsis patients. In this study, the~     investigators has planned to enroll 100 subjects, including 20 cases with systemic~     inflammatory response syndrome (SIRS), 20 cases with sepsis, 20 cases with severe sepsis and~     20 with septic shock. In addition, this study also include 20 normal cases as control. The~     serum sample of patients with sepsis is draw on days 1, 3, 5, 7, 10, and 14 after first ICU~     admission. High-performance liquid chromatography and tandem mass spectrometry was used to~     detect the quantification of amino acids. The amino acids expression profiling contain~     Arginine, Ornithine, Histidine, Cystine, Isoleucine, Cystathionine, Leucine, Homocystine,~     Lysine, α-Amino-n-Butyric Acid, Methionine, Alanine, Phenylalanine, Anserine, Threonine,~     β-Alanine, Tryptophan, β-Amino-Isobutyric Acid, Valine, Carnosine, γ-Amino-n-Butyric Acid,~     Ethanolamine, Glycine, δ-Hydroxylysine, Serine, Hydroxy-L-Proline, Taurine,~     1-Methyl-L-Histidine, Tyrosine, 3-Methyl-L-Mistidine, α-Amino-Adipic, Phospho-Ethanolamine,~     Asparagine, Phospho-L-Serine, Aspartic acid, Proline, Citrulline, Sarcosine, Glutamic acid,~     Argininosuccinic Acid, Glutamine, Homocitrulline. The investigators speculate that~     measurement of amino acids expression profiling could be taken as an indicator for assessment~     in critically ill patients.~   "
133581|NCT01818817|"~     The purpouse of the study is to determine wether Ultrasound Guided,Ens-assisted paravertebral~     block with single shot is a safe and reliable anesthetic technique in breast surgery.~   "
133582|NCT01818804|"~     Background: There is evidence for a high cardiovascular risk in rheumatic and inflammatory~     diseases . Recent evidence suggest that psoriatic arthritis is also associated with an~     increased cardiovascular risk with accelerated atherosclerosis and increased cardiovascular~     risk. However, data regarding cardiovascular comorbidity and cardiovascular risk factors in~     patients with psoriatic arthritis are limited.~      Objective: The aim of this study is to investigate the effect of daily supplementation with 3~     g n-3 polyunsaturated fatty acids on risk markers for cardiovascular disease and inflammation~     in patients with psoriatic arthritis.~      Design: Randomized double-blind, placebo-controlled, multicenter trial with n-3~     polyunsaturated fatty acids in patient with psoriatic arthritis.~      Setting: Departments of Rheumatology, Nephrology and Cardiology at Aalborg University~     Hospital and Vendsyssel Hospital in Region Northern Denmark~      Participants: 156 men and women aged > 18 years with psoriatic arthritis classified by the~     CASPAR criteria will be included. Exclusion criteria: cardiac arrhythmias, conduction~     disturbances, treatment with biological drugs or oral corticosteroids. Inclusion time: spring~     2013 to spring 2015.~      Method: The following data will be collected for each participant: Interview including~     dietary records, assessment of tender and swollen joints, enthesitis, dactylitis, patient~     global assessment of disease activity (Visual Analogue Scale ), global assessment of pain~     (Visual Analogue Scale), psoriatic skin involvement by Psoriatic Area and Severity Index~     (PASI), laboratory parameters of disease activity and risk markers of cardiovascular disease.~      For detection of early cardiovascular risk markers Heart Rate Variability (HRV) and Pulse~     Wave Velocity (PWV) will be performed.~      Main outcome measures: The primary endpoint will be HRV and secondary endpoints will be PWV,~     inflammatory activity and use of analgesics.~      The trial is approved by The local Ethics Committee, registration number N20120076~   "
133583|NCT01818791|"~     As a nation, the U.S. invests heavily in community-based organizations to conduct~     interventions, proven through research, to reduce the high rates of unplanned pregnancies and~     sexually transmitted infections (STIs) and HIV among teens. Much less is invested in helping~     communities implement these programs with quality. Although many research-based programs~     exist to address teen pregnancy and STIs, communities face difficulty implementing them and~     achieving the same outcomes as researchers. This gap is because resources are limited,~     prevention is complex, and communities often lack the capacity—or the knowledge, attitudes,~     and skills—needed to implement off the shelf programs well. Common ways to bridge this gap,~     such as information dissemination, fail to change practice or outcomes at the local level in~     part because it does not sufficiently address capacity of community practitioners. Therefore,~     building a community's capacity is a method that could improve the quality of implementation~     and outcomes. The proposed study will use a randomized controlled design and primary data~     from middle school youth (960) and program staff from 32 cooperating Boys and Girls Clubs~     (Clubs) to assess how a capacity building intervention called Getting To Outcomes (GTO)~     augments the quality of implementation of a research-based intervention to improve teen~     sexual health (Making Proud Choices, MPC). Specifically, the study will: (1) Assess the~     utilization of and subsequent effects of GTO on program staff capacity to implement MPC; (2)~     Assess the degree to which Clubs using GTO show greater improvements in MPC fidelity than~     Clubs that are not using GTO; and (3) Assess the degree to which Clubs using GTO show greater~     improvements on teen sexual health outcomes than the comparison Clubs. To address these aims~     we will collect data on the delivery and utilization of GTO (e.g., method of delivery,~     duration, topics); staff capacity to implement research-based interventions; observations of~     program delivery (fidelity monitoring); and youth participants' sexual activity, pregnancy,~     STIs, condom use, and knowledge/ attitudes towards sex. Analyses will examine differences~     between intervention and control sites over time, accounting for clustering of youth within~     site. These outcomes are important to NICHD's focus on providing opportunities for youth to~     become healthy and productive adults.~   "
133584|NCT01818778|"~     Many volunteers visiting seniors make socially-based friendly visits. This study~     investigated the efficacy of volunteers making visits focused on stimulating cognition.~     Participants were randomly assigned to either a friendly visit control group or a cognitive~     stimulation group. Seniors receiving stimulation visits made statistically significant~     improvement in memory abilities.~   "
133585|NCT01818765|"~     Cardiac resynchronization therapy (CRT) is known to result in significant improvement in the~     symptoms of selected patients with heart failure, and to reduce hospital admission and death~     rates in these patients. CRT can improve cardiac function by improving the coordination of~     the heart beat using a special pacemaker. This requires a wire in the coronary sinus, one of~     the veins running around the outside of the heart, to stimulate the outside of the left~     ventricle (main pumping chamber).~      There are two particular issues with this standard technique. In some patients it is not~     possible to get the wire into the coronary sinus due to difficult vein shapes, and in others~     the wire can be put there, but it does not end up in a suitable position to act on the heart~     enough to improve heart function. This is thought to be a major part of the reasons why one~     in four patients does not improve with CRT (non-responders).~      The investigators have developed a novel method of pacing the left ventricle of the heart by~     putting the wire through a tiny hole made in the muscle between the left and right ventricles~     and pacing the inside surface of the left ventricular chamber. This will allow patients in~     whom the coronary sinus cannot be used to have CRT. The investigators will also offer it to~     patients who have not improved with CRT, as there is evidence that they may respond to this~     procedure due to physiological benefits from pacing the inside rather than the outside and~     also the ability to steer the lead anywhere on the inner surface.~      The investigators have performed this new procedure in a small number of patients already.~     This study will allow closer follow-up of more patients, and also investigation of ways to~     optimize results of the procedure for these patients.~   "
133586|NCT01818752|"~     The primary objective was to compare the progression-free survival of transplant ineligible~     patients newly diagnosed with multiple myeloma who were treated with carfilzomib, melphalan~     and prednisone (CMP) or with Velcade® (bortezomib), melphalan and prednisone (VMP).~   "
133589|NCT01818713|"~     Leptomeningeal metastases (LM) develop when tumor cells reach the cerebrospinal fluid (CSF)~     and infiltrate the leptomeninges. The median survival of patient with breast cancer and LM is~     4-6 months with up to 25% long-term survivors. Many potentially highly efficacious~     intravenous chemotherapies are currently not effective to treat LM because they do not~     adequately cross the blood-CSF barrier.~      Doxorubicin, the anthracycline chemotherapeutic agent, has a well-established antineoplastic~     activity in breast cancer. To optimally enhance the delivery of liposomal doxorubicin to the~     brain, to-BBB technologies B.V. has designed a glutathione (GSH) pegylated liposomal~     doxorubicin hydrochloride formulation (2B3-101). Coating of liposomes with PEG ensures the~     prolonged circulation time in plasma, whilst conjugation of GSH to the tips of the PEG~     molecules targets the liposomes towards the active GSH transporters on the BBB to enhance the~     delivery of doxorubicin to the brain.~      This is a a clinical and pharmacological study that aims to determine preliminary efficacy of~     treatment with 2B3-101 in patients with leptomeningeal metastases of breast cancer using the~     LM response score.~   "
133590|NCT01818700|"~     The purpose of this study is to assess the pain reduction rate after 8 weeks treatment of~     NORSPAN® from baseline.~      And secondary purpose are: pain reduction rate after 4 weeks treatment from baseline(week 0)~     the EQ-5D, the pain and sleep questionnaire, physician's overall satisfaction subject's~     overall satisfaction, and safety~   "
133591|NCT01818687|"~     The objective of this study is to assess the safety and tolerability of colestilan (MCI-196)~     in paediatric subjects (aged 2 years to <18 years) with CKD stages 3b to 5, diagnosed with~     hyperphosphataemia, who are not on dialysis.~   "
133592|NCT01818674|"~     The Microclinic Social Network Behavioral Health Trial for Obesity and Metabolic Risk Factor~     Control in Jordan spans 51 months and aims to test the effectiveness of the Microclinic~     Social Network Behavioral Health Program in influencing lifestyle behavioral risk factors to~     improve diabetes management that effect weight and metabolic outcomes through social~     networks. The Microclinic Social Network Behavioral Health Program provides microclinic (MC)~     groups—consisting of approximately 2-8 individuals from pre-existing social networks~     (friends, relatives, coworkers, neighbors, etc)—with shared access to diabetes education,~     technology, and group support to promote weight and metabolic control through diet, exercise,~     medication adherence, and blood pressure management. MC members play a role in the collective~     effort to combat diabetes and solidifying self-management behavioral skills through~     peer-monitoring and encouragement of lifestyle behaviors.~      This Microclinic Social Network Behavioral Health Trial was established in collaboration with~     the Royal Health Awareness Society (RHAS) and the Jordanian Ministry of Health (MoH).~      This objective of the Microclinic Social Network Behavioral Health Trial, the first~     randomized control study of its kind, is to test the effectiveness of the Microclinic Social~     Network Behavioral Health Program. The study will yield valuable information on the impact of~     social relationships with diabetes education on weight and metabolic control among~     individuals with type 2 diabetes.~   "
133593|NCT01818661|"~     The study is designed to determine the relationship between structural and functional changes~     in the brain on imaging and progression of speech and language, neurological and~     neuropsychological features in patients with neurodegenerative apraxia of speech (AOS).~   "
133594|NCT01818648|"~     We plan to examine the gastrointestinal (GI) physiologic profile of Exenatide, a~     glucagon-like peptide (GLP-1) analog as a possible intestino-trophic growth factor capable of~     inducing small bowel adaptation and regeneration in patients with short bowel syndrome (SBS),~     with the potential to decrease parenteral nutrition dependence.~   "
133595|NCT01818635|"~     The purpose of the study to investigate whether montelukast lead to behavior problems in~     children with asthma.~   "
133596|NCT01818622|"~     In this randomized controlled study we will investigate the effect of blue-blocking goggles~     or screens (virtual darkness therapy) on manic symptoms in bipolar disorder compared to~     placebo. This 3-armed study includes 2 patient-groups and a non-bipolar control-group. The~     main hypothesis is that virtual darkness therapy is effective as additive treatment in~     mania.Other hypotheses are that virtual darkness therapy has significant effects on sleep,~     motor activity, circadian rhythm and mood also in the non-bipolar control-group.~   "
133597|NCT01818609|"~     Skeletal muscle mass declines with inactivity (casting is a good example) and increases with~     activity (such as weightlifting). Whether muscle mass increases or decreases, is determined~     by whether more new proteins within muscle are made than are broken down. The investigators~     know that feeding protein increases the synthesis of new proteins but that the response of~     older muscles to protein feeding is blunted compared with the young. This resistance of the~     elderly to muscle building stimuli may be the primary reason that muscle mass is lost in~     aging. The investigators also know that periods of muscle disuse such as casting result in a~     person's muscle shrinking due, the investigators believe, to a lower rate of synthesis of new~     muscle proteins. Age-related muscle loss begins around 50 years old and proceeds at~     approximately 1% for every year after. Elderly persons would likely fare well with advancing~     age if their muscle loss were simply linear; however, a rate of muscle loss of 1% annually is~     a 'population view' and does not represent what occurs during short periods of muscle disuse~     (i.e. during hospitalization or illness), which occur with increasing frequency in elderly~     persons. During periods of disuse, the resistance of elderly muscles to protein nutrition may~     be worsened. The investigators will measure how quickly new proteins are made at rest and~     after protein feeding in elderly men, before and after a 14 day period of reduced activity~     brought on by having people reduce their daily step count.~   "
133598|NCT01818596|"~     This open-label, multicenter, multi-cohort study is to assess the safety, tolerability, and~     efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF)~     fixed-dose combination (FDC) tablet in treatment-naive and treatment-experienced~     HIV-positive, adult participants with mild to moderate renal impairment.~      The primary objective of this study is to evaluate the effect of E/C/F/TAF on renal~     parameters at Week 24. The proportion of subjects achieving virologic response of HIV-1 RNA <~     50 copies/mL will also be assessed.~      At sites able to conduct the appropriate testing, approximately 30 participants will be~     enrolled into an intensive pharmacokinetic/pharmacodynamic (PK/PD) substudy to evaluate the~     PK/PD parameters of the individual components of E/C/F/TAF as well as tenofovir diphosphate~     (TFV-DP).~   "
133599|NCT01818583|"~     Atrial fibrillation is a condition in which the heart's upper chambers, the atria, contract~     at an abnormally rapid rate. It is a common type of arrhythmia, and occurs in 1-2% of the~     general population. The prevalence of atrial fibrillation increases with age. Between 50 and~     70% of patients with atrial fibrillation lasting <48 hours spontaneously convert to normal~     sinus rhythm, and drug therapy increases the likelihood of conversion to sinus rhythm.~     Another treatment option for conversion of atrial fibrillation and atrial flutter is~     electrical conversion. This is an effective treatment but requires anesthesia.~      Current treatment strategy for medical conversion of atrial fibrillation and atrial flutter~     is to employ drugs that affect ion channel activity in atrial cardiomyocytes. However, such~     converting drugs all have potentially serious side effects and are expensive. Potassium,~     sodium, calcium, and magnesium molecules are the most important ions causing electric current~     in the heart tissue. Our hypothesis is that hypokalemia promotes atrial fibrillation/atrial~     flutter by a direct effect on cardiomyocytes. Accordingly, we also hypothesize that potassium~     infusion may convert atrial fibrillation/atrial flutter to normal sinus rhythm. If so, this~     would be an inexpensive treatment with potentially very few side effects.~   "
133600|NCT01818570|"~     The purpose of this trial is to evaluate the effect of a single PPC‐5650 dose in a human pain~     model including multimodal (mechanical, thermal, electrical, chemical) stimulations of the~     esophagus.~   "
133601|NCT01818557|"~     The incidence of gestational diabetes mellitus (GDM) is increasing. GDM requires patients to~     test their blood glucose at least four times daily. The investigators propose to~     prospectively evaluate blood glucose testing done every day compared to every other day. The~     primary goal is to establish the most cost-effective modality while still being able to~     detect patients who require therapy in a timely fashion. The investigators plan to evaluate~     this new management scheme utilizing a non-inferiority trial design.~      The investigators primary research question is the following: When managing patients with~     GDM, is every other day blood glucose testing non-inferior compared to every day blood~     glucose testing, as measured by the difference of less than 5% in birth weight?~   "
133602|NCT01818544|"~     The primary objective of this study is to assess the safety and tolerability of 28 day oral~     administration of BAY85-8501 versus placebo in subjects with non-CF Bronchiectasis (BE).~      The secondary objectives are to examine the effect of BAY85-8501 on pulmonary function,~     biomarkers of inflammation and tissue damage, and the impact on overall health and perceived~     well-being and to evaluate the pharmacokinetics of BAY85-8501.~   "
133603|NCT01818531|"~     This study will evaluate the affects of a single injection ultrasound-guided adductor canal~     block for patients undergoing robotic-assisted (MAKOplasty) medial UKA (unicompartmental knee~     arthroplasty). Specifically, this study will compare the adequacy of postoperative analgesia~     provided by the adductor canal block with that provided by single injection lumbar plexus~     blockade. The working hypothesis is that the analgesia provided by the adductor canal block~     will be equivalent to the analgesia provided by the lumbar plexus block. The primary outcome~     will be a comparison of verbal numerical pain scores at rest and with movement over the first~     24 hours following nerve blockade.~   "
133604|NCT01818518|"~     To determine the rate of Composite Neonatal Morbidity for very preterm babies delivered~     secondary to preterm labor (PTL) vs. prelabor rupture of membranes (PROM). Composite neonatal~     morbidity is defined as ≥ 1 of the following: Respiratory Distress Syndrome (RDS) (oxygen~     requirement, clinical diagnosis, and consistent chest radiograph), bronchopulmonary dysplasia~     (BPD) (requirement for oxygen support at 28 days of life), severe intraventricular hemorrhage~     (IVH) (grades III or IV), periventricular leukomalacia (PVL), blood culture-proven sepsis,~     necrotizing enterocolitis (NEC), or perinatal death (stillbirth or death before neonatal~     hospital discharge.~   "
133605|NCT01818505|"~     Patients with hyperuricemia were confirmed to have higher risks of cardiovascular disease,~     but the exact mechanism remained to be elucidated. Many connective tissue diseases such as~     rheumatoid arthritis are often associated with antiphospholipid antibodies-associated~     endothelial impairment. In the present study, the investigators will analyze the presence of~     antiphospholipid antibodies in the serum of the patients with gout/asymptomatic~     hyperuricemia, with a comparison to the patients of osteoarthritis but without hyperuricemia~     and gout. The investigators expect to find a correlation between these pathogenic antibody~     and those cardiovascular co-morbidities.~   "
133606|NCT01818492|"~     The purpose of this study is to assess the safety, tolerability and efficacy of a new drug~     aimed at controlling disease activity in patients diagnosed with primary haemophagocytic~     lymphohistiocytosis. The new drug can be administered as the first-line therapy, to patients~     not previously treated with the current standard of care, or can be given to patients who~     have either failed or were unable to tolerate the current standard of care. Administration~     will be on top of a glucocorticosteroid, which is usually part of the current recommended~     treatment.~   "
133607|NCT01818479|"~     Open label, dose finding trial to assess the efficacy of Treg/Tcon addback to partially~     matched related donor stem cells. The maximum tolerated dose will be established using 3~     subjects per dose level, with an expansion cohort at the maximum tolerated dose.~   "
133608|NCT01818466|"~     The aim of this study is to evaluate the clinical and radiographic outcomes of patients who~     have previously undergone tibiotalar arthrodesis using an anterior approach with blade-plate~     fixation for tibiotalar arthritis secondary to injury to the articular surface of the distal~     tibia.~   "
133609|NCT01818453|"~     The goal of this project is to determine whether genetic information can be used to predict~     response to an internet-based treatment of depression. Several studies now indicate that~     completing an internet-based treatment for depression, called Deprexis, can significantly~     improve symptoms of depression. However, not everyone improves. The purpose of this study is~     to determine whether genetic profile can predict who is likely to improve.~   "
133650|NCT01817920|"~     Falls are very common accidents in Hospital. It not only results in injuries, less mobility~     among patients but increases their length of stay, cost and family burdens. Reducing the~     rates and injuries of falls is an urgent issue around hospitals.~      An integrated multidisciplinary fall prevention program (IMFPP) was implemented from 2006 in~     CCH. Members include physicians, nurses, case manager therapists, engineers and staffs of~     maintenance. The aim of this study is to determine whether IMFPP efforts support~     interventions with multiple components do reduce the fall rates and severity of injuries.~   "
133610|NCT01818440|"~     Background:~      - Researchers are interested in comparing two methods that doctors can use to position~     catheters in blood vessels. These methods are used to deliver chemotherapy and close the~     blood supply to a tumor. The methods are the standard method called fluoroscopy and a new way~     called 3-D Roadmap. The 3-D Roadmap software uses computed tomography (CT) images to help the~     doctor choose the best position for the catheter to get to the tumor. The computer shows the~     route on an x-ray screen in real time. This technique may help doctors position the catheter~     with less x-ray dye and in a shorter time. These methods will be compared in people who are~     having a procedure to destroy liver tumors. The procedure, called trans-arterial~     embolization, will deliver chemotherapy and destroy the tumor blood supply.~      Objectives:~      - To compare the effectiveness of fluoroscopy or 3-D Roadmap software for liver tumor~     treatment.~      Eligibility:~      - Individuals at least 18 years of age who are having trans-arterial embolization for liver~     cancer.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will~          provide blood and urine samples, and have imaging studies.~        -  Participants will be divided into two groups. One group will have regular fluoroscopy~          (X-ray) during the procedure. The other group will have the procedure with the 3-D~          Roadmap software.~        -  In the first group, participants will have a CT scan. The doctor will decide how many~          vessels need to be treated. The doctor will advance the catheter using fluoroscopy only.~          Another CT scan will be given after the procedure.~        -  In the second group, participants will have a CT scan. The doctor will look at the scan~          with the 3-D Roadmap software. The software will show the path to advance the catheter.~          The doctor will use the software to help destroy the tumors. Another CT scan will be~          given after the procedure.~        -  Both groups will have the same follow-up care afterward. Other tests will be given as~          needed for the cancer treatment.~   "
133611|NCT01818427|"~     To determine the effect of the prehospital infusion during air transport of 2 units of AB~     plasma on 30 day mortality in patients with hemorrhagic shock as compared to conventional~     care.~   "
133612|NCT01818414|"~     Cervical preparation before second trimester dilation and evacuation (D&E) reduces risks and~     complications. Osmotic cervical dilators as well as prostaglandin analogues have been studied~     for cervical preparation. However, the optimal method for cervical preparation, especially~     for D&E procedures that occur on the same day as cervical preparation, is not known. This~     study will investigate misoprostol versus placebo as an adjunct to Dilapan-S for cervical~     preparation for same-day D&E between 16+0 and 20+6 weeks gestation.~      HYPOTHESIS: Administration of 400 µg buccal misoprostol compared to placebo at least 3 hours~     prior to D&E as an adjunct to cervical preparation with Dilapan-S will decrease operative~     time for same-day D&E performed between 16+0 and 20+6 weeks.~   "
133613|NCT01818401|"~     Over 70.000 total knee arthroplasty (TKA) are performed in France every year, with a 10%~     yearly increase since the early 1990s. The clinical experience shows a strong rate of success~     on pain relief and on function. Longevity of the implants has been shown to be determined by~     the biomechanical design of the prosthesis, and by the implantation technique, especially the~     correct positioning of the bone cuts during the surgery. To improve the precision of these~     cuts, the patient matched cutting blocks developed by Medacta allow to adapt the bone cuts to~     the patient's anatomy, improving the reliability of this procedure. A reduction of the~     surgery time lengh and bleeding would be other benefits expected with this type of ancillary.~     The objective of this trial is to study the reliability of patient matched cutting blocks for~     total knee arthroplasty, by both clinical and radiological assessment, the effect on~     morbidity reduction during and after the procedure and also the benefit it could bring on an~     economic point of view.~   "
133614|NCT01818388|"~     A multicenter prospective single arm interventional trial in hospitals where therapeutic~     hypothermia is standard practice. This trial will enroll 50 subjects to evaluate the ability~     of the ZOLL Intravascular Temperature Management (IVTM) System to induce, maintain, and~     reverse mild therapeutic hypothermia and maintain normothermia post cardiac arrest.~   "
133615|NCT01818375|"~     Despite Goal Directed Fluid Therapy (GDFT) has shown a reduction of hospitalization and~     overall complications in patients undergoing abdominal surgery, there is a need to address~     the effect of implementing GDFT on the incidence of specific surgical complications and in a~     context of en enhanced recovery program (ERP). Specifically, studies investigating the impact~     of GDFT on primary postoperative ileus (POI) in patients undergoing laparoscopic colorectal~     surgery and using an ERP are missing.~      It is hypothesized that the incidence of primary POI will be reduced in patients receiving~     intraoperative GDFT compared to patients receiving Standard Fluid Therapy (SFT) after~     elective laparoscopic colorectal surgeries with an ERP program.~   "
133616|NCT01818362|"~     This will be a randomised observational phase 1 study in 48 healthy volunteers aged 18-50.~     The study is assessing safety and immunogenicity of viral vectored vaccines ChAdOx1 NP+M1 and~     MVA NP+M1 in heterologous prime-boost regimens. A crossover design will allow comparison of~     the two vaccines. Volunteers will be divided into 4 groups (n=12 in each group). Groups will~     be recruited simultaneously to control for seasonal changes in influenza. This is because at~     certain times of year there is likely to be a higher naturally acquired T cell response to~     influenza than at other times due to circulating influenza virus in the community.~      The study has been extended to include 2 additional groups (group 5 & 6), each containing 12~     healthy adults aged 50 years or above. Group 5 will receive ChAdOx 1 NP+M1 on day 0, and~     group 6 will receive this with an additional boost of MVA-NP+M1 8 weeks later.~   "
133617|NCT01818349|"~     Background: A discrepancy between strength gain and gait changes following various training~     programs aimed at improving gait function after stroke has been noted. A mismatch between the~     training program and gait parameters could explain this finding.~      Objective: To evaluate the impact of an isokinetic-strengthening program, matching the~     requirements of the affected lower-limb muscle groups involved in the energy generation of~     gait, to a control intervention, on gait performance and muscle strength.~      Hypothesis: The isokinetic training program of the affected lower-limb muscles would produce~     greater changes in gait performance and strength than a control intervention not aiming at~     training these muscle groups.~      Design: Single-blinded randomized controlled trial.~      Participants: A convenient sample of 30 individuals with chronic hemiparesis.~      Interventions: Participants were randomly assigned into two groups (n=15), each training~     three times/week for six weeks. The experimental group trained the affected plantarflexors,~     hip flexors and extensors concentrically, while the control group trained the affected~     upper-limb muscles.~      Main outcome measures: Baseline values and post-training values, taken at the end of the~     training program, of maximal voluntary concentric strength, gait speed and peak positive~     power.~   "
133702|NCT01817244|"~     Suicide is a significant cause of death in Korea. According to the report compiled by the~     Korea National Statistical Office, 24.8 victims of every 100,000 in 2007 (Korea National~     Statistical Office, 2008), which is higher compared with 10.1 in the United States, 6.0 in~     the United Kingdom, and 19.1 in Japan (Organisation for Economic Co-operation and~     Development, 2008). Especially, suicide rate is incredibly higher in elderly. Most persons~     who commit suicide have a diagnosed psychiatric disorder. Among them, 60% had Depression when~     they committed suicide. Therefore, this study aimed the impact of a care management~     intervention on depression treatment and reducing suicidal ideation in elderly patients with~     depression.~   "
133618|NCT01818336|"~     A self- or parent-reported history of penicillin allergy excludes approximately 10% of the US~     population from receiving penicillin (Kerr 1994, Kagy, Blaiss 1998, Solensky et al. 2000,~     Neugut et al. 2001). Yet approximately 80% of patients labeled as allergic to the penicillins~     can safely take these antibiotics without fear of a life-threatening reaction (Gadde et al.~     1993, Macy et al. 1997). The outcomes of this erroneous classification of patients include~     unnecessary denial of an effective and well-tolerated class of antibiotics, which are often~     the treatment of choice.~      The primary aim of skin testing with the Penicillin Skin Test Kit is to identify subjects at~     very low risk of developing acute IgE-dependent reactions when given a penicillin or~     cross-reacting drug. The negative predictive value (NPV) of skin testing is assessed by oral~     challenge with a penicillin.~   "
133619|NCT01818323|"~     The overall goal of this study is to investigate the safety of T4 immunotherapy when~     administered to treat loco-regional disease in Squamous Cell Cancer of the Head and Neck~     (SCCHN) that is not suitable for conventional active therapy.~      The investigators propose to conduct an open-labelled, non-randomized, dose-escalation phase~     I trial in which autologous T4+ T-cells are administered to patients with SCCHN. T-cells will~     be engineered to express a second generation chimeric antigen receptor (CAR) named T1E28z.~     Engineered T-cells will be injected directly into the tumour site. Patients will not be~     lymphodepleted. A classical 3+3 design will be employed, with dose escalation from 10^7~     through to 10^9 transduced T4+ T-cells, dependent upon toxicity monitoring. It is anticipated~     that up to 30 patients will be enrolled over the course of the study.~   "
133620|NCT01818310|"~     The aim of the presented clinical trial is to evaluate a hypothesis, that BMAC prepared from~     bone marrow aspirate and injected intramuscularly into ischemic areas of the lower extremity~     in patients with diabetes mellitus type II., intraarterially into the defect of the limb or~     with an intravenous application only, has a greater potential to improve the perfusion in the~     ischemic limbs than standard treatment of NO-CLI. Another aim of the study is to find out~     differences among three different therapeutic types of BMAC application, to define their~     effectiveness and safety and to compare the impact of different means of application to the~     speed of healing of the limb defects and the improvement of perfusion parameters.~   "
133621|NCT01818297|"~     The purpose of this study is to assess the safety and efficacy of Subcutaneous Nerve~     Stimulation (SQS) (also known as Peripheral Nerve Stimulation [PNS]) in the reduction of~     chronic, intractable post-surgical back pain in adults.~   "
133622|NCT01818284|"~     The goal of this clinical research study is to learn if treating stem cell donors with~     filgrastim (G-CSF) and plerixafor (Mozobil®) can cause them to produce a higher number of~     blood stem cells than filgrastim by itself. Researchers also want to learn if giving both of~     these drugs helps donors produce enough stem cells so that only 1 apheresis procedure needs~     to be performed.~      Researchers will study if using both drugs lowers the risk of the stem cell transplant~     recipients developing severe forms graft-versus-host disease (GVHD). GVHD is a condition in~     which transplanted tissue (such as blood stem cells) attacks the tissue of the recipient's~     body.~      The safety and effectiveness of this drug combination will also be studied.~      Filgrastim and plerixafor are both designed to help move or mobilize the stem cells from~     the bone marrow to the blood.~   "
133623|NCT01818271|"~     Stroke patients clearly benefit from intensive and coordinated inpatient care. While~     inpatient rehabilitation care is the preferred form for many patients post-stroke, due to~     access and financial barriers, many patients do not have this option. Community, outpatient~     rehabilitation programs will allow the patients with moderately disabling strokes the~     opportunity to maintain or augment gains achieved during inpatient stroke rehabilitation ,~     while allowing some patients with mild disability to avoid inpatient rehabilitation~     completely.~      Objective: Phase 1 randomized control trial to test the efficiency and effectiveness of~     treating adults who have suffered a single stroke using the following essential treatment~     components; a) community setting, b) group activity program, c) flexible, task-specific,~     computer-based exercise regime This program is designed to allow an extension of the~     in-patient rehabilitation experience to a community-based setting, in a cost-effective manner~     using paraprofessional staff and rehabilitation specialists, to provide a challenging,~     functional program to promote recovery and independence from physical impairments affecting~     balance and walking.~      The specific objectives are to:~        1. assess the benefits and feasibility of the multi-functional group exercise intervention~          for balance and mobility in a community setting. Secondary objectives~        2. identify effective combinations of exercises & activities that translate to increased~          abilities and participation levels.~      Hypothesis: Intense training targeting standing balance, and walking will significantly~     improve stroke clients' functional mobility. Training in a group setting and incorporating~     interactive and engaging computer gaming further provides the benefits of motivation and peer~     support while providing treatment in a cost effective manner.~   "
133624|NCT01818258|"~     HIV-infected children from sub-Saharan Africa often present with severe malnutrition. In~     severe malnutrition, metabolic and/or gut structural derangement may lead to inadequate~     antiretroviral (ARV) absorption and/or erratic drug levels. The greater surface area to~     weight ratio in severely malnourished children could also place them at higher risk of under~     dosing compared to children with mild to moderate malnutrition. However, limited data are~     available on the pharmacokinetics of ARVs in severely malnourished children. This study will~     address this critical gap in knowledge by evaluating the PK of zidovudine (ZDV), lamivudine~     (3TC), and lopinavir/ritonavir (LPV/r) in severely malnourished children, compared to~     children with normal nutrition to mild malnutrition.~   "
133625|NCT01818245|"~     This study will include two groups (cohorts) of participants:~      In Group A, this study will look at the amount of LY2605541 that is present in the body after~     it is injected in 3 different locations in the body of the same participant. At least 16 days~     will pass between each injection.~      In Group B, the study will look at how the body absorbs, distributes, and gets rid of~     LY2605541 in participants over age 65.~      Participants may enroll in only one group.~   "
133626|NCT01818232|"~     This phase 1 study is to evaluate the pharmacokinetics (PK), metabolism, routes and extent of~     elimination of a single oral dose of 400 mg [14C]LX4211 to healthy male subjects~   "
133651|NCT01817907|"~     In Obstructive sleep apnea (OSA), the upper airway closes over and over again during sleep.~     This leads to disrupted sleep (waking up during the night), daytime sleepiness, and an~     increased risk for developing high blood pressure. Currently, the best treatment for~     obstructive sleep apnea is sleeping with a mask that continuously blows air into the nose~     (i.e. Continuous positive airway pressure [CPAP] treatment). While CPAP treatment stops the~     upper airway from closing in most people, many people have difficulty sleeping with the mask~     in place and therefore do not use the CPAP treatment. This research study is being conducted~     to learn whether using a sedative will improve OSA severity by altering some of the traits~     that are responsible for the disorder.~   "
133627|NCT01818219|"~     Due to recent technological improvements, it is now possible to record the electrical~     activity of the diaphragm (Eadi), a direct expression of the central nervous system~     respiratory center activity. By providing a relatively easy-to-use technique to record Eadi~     the NAVA (Neurally Adjusted Ventilatory Assist) technology offers a new opportunity to~     explore the effects of various interventions on neural inspiratory activity in human subjects~     during spontaneous and assisted ventilation both for normal and simulated abnormal~     respiratory mechanics.~      The main aim of this project is to measure and compare the components of Eadi signal, the~     direct reflect of the respiratory centers activity, under various conditions of normal and~     simulated altered respiratory mechanics (either obstructive or restrictive respiratory~     mechanics° in order to better understand the neuroregulation of breathing. The second aim of~     the present project is to perform a similar analysis regarding the effects of various modes~     (Pressure Support and NAVA) and various levels of assisted ventilation both in case of normal~     and abnormal respiratory mechanics. Based on the information recorded on Eadi and flow and~     pressure signals, the last aim of this project is to correlate Eadi and pneumatic derived~     parameters both during spontaneous breathing and assisted ventilation.~      Practically, by using the NAVA recording technology, the investigators will perform a~     physiological study on normal volunteers to explore the effects of normal and simulated~     abnormal respiratory mechanics on Eadi, flow and pressure signals (airway, oesophageal and~     transdiaphragmatic pressures) in order to better understand the neuroregulation of breathing.~     Thirty healthy volunteers with documented normal lung function tests will be included in the~     study (obstructive respiratory mechanics will be simulated in 15 healthy volunteers and~     respiratory mechanics will be simulated in 15 healthy volunteers).~   "
133628|NCT01818206|"~     Pulmonary phage therapy to treat bacterial infections of the respiratory tract have been~     investigated in animals. The aim of the present study is to evaluate the efficacy of~     bacteriophages in infecting Pseudomonas aeruginosa (PA) strains present in sputum samples. A~     cocktail of 10 bacteriophages will be applied on 60 sputum samples obtained from cystic~     fibrosis (CF) patients during 6 hours.We will determine the bacteria and bacteriophages~     strains in sputum samples collected. Then the sensitivity of individual colony will be~     tested.~   "
133629|NCT01818193|"~     A monocentric prospective open study to evaluate the frequency and nature of cognitive~     complications in the 3rd month post pulmonary transplant.~   "
133630|NCT01818180|"~     Evaluation of the effect of URELL consumption on the occurrence of recurrent urinary tract~     infection (Acute cystitis, pyelonephritis and asymptomatic bacteriuria).~   "
133631|NCT01818167|"~     The purpose of this study is to compare the efficacy of Provodine™ topical cream to 10%~     benzoyl peroxide topical body wash for the treatment of early stage hidradenitis suppurativa.~   "
133632|NCT01818154|"~     The purpose of this study is to validate a new hand held light emitting diode (LED) device~     for the measurement of minimal erythema dose (MED) for narrow band Ultraviolet B (UVB)~     radiation by comparing to the traditional approach of measurement of the minimal erythema~     dose.~   "
133633|NCT01818141|"~     The purpose of this study is to compare number of vegetative cells and spores in stool over~     time for fidaxomicin or vancomycin in patients diagnosed with their first episode of C.~     difficile infection.~   "
133634|NCT01818128|"~     The purpose of this study is to investigate whether flexion of bronchial tip of a left-sided~     double lumen endobronchial tube prevents tube misplacement to the right mainstem bronchus.~   "
133635|NCT01818115|"~     The objective of this study is to demonstrate the ability of the Hydrus Implant to lower~     intraocular pressure in glaucoma patients undergoing cataract surgery.~   "
133636|NCT01818102|"~     The purpose of this study is to investigate the appropriate window setting of chest computed~     tomography to select a correct size of double-lumen endobronchial tube.~   "
133637|NCT01818089|"~     The aim of this study is to investigate if any correlation between lung sounds of pneumonia~     patients and the clinical development or therapy of the pneumonia exists.~   "
133638|NCT01818076|"~     This study will evaluate the long-term safety of botulinum toxin type A for the treatment of~     moderate to severe crow's feet lines after repeat application.~   "
133639|NCT01818063|"~     This randomized phase II trial studies how well carboplatin and combination chemotherapy with~     or without veliparib works in treating patients with stage IIB-IIIC breast cancer. Drugs used~     in chemotherapy, such as paclitaxel, carboplatin, doxorubicin hydrochloride, and~     cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. Veliparib may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. It is not yet known whether giving~     carboplatin and combination chemotherapy are more effective with or without veliparib is more~     effective in treating breast cancer.~   "
133640|NCT01818050|"~     Endoscopic retrograde cholangiopancreatography (ERCP) with plastic stent placement for~     resolution of biliary obstruction has been the method of choice for many years. However,~     stent clogging/obstruction is a major limitation in the management of biliary obstruction.~     Studies have shown that the conventional tubular type polyethylene stents (CS) with side~     holes accumulate significant sludge and their mean patency is approximately 90 days.~      Thus patients requiring longer term stenting need to undergo stent exchanges every 2-3~     months.~      Recently, a stent with a star-shaped cross-section has been developed for biliary~     applications. This FDA approved biliary Wing stent (WS) (ViaDuct™) is a novel plastic biliary~     stent that lacks a lumen, and is designed to allow bile to flow on the outside of the stent.~     The stent which is star shaped in cross section, channels fluid along its winged perimeter.~     It has been proposed that the winged stent design with a lack of central lumen obviates the~     risk of luminal occlusion and that the risk of occlusion, given the presence of multiple~     external drainage channels, is smaller. Longer term biliary drainage without the need for~     stent exchange should therefore be possible with these stents.~      The primary aim of this study is to prospectively evaluate the patency rate of the WS up to~     90 days in 50 patients with biliary obstruction due to stones or benign strictures.~   "
133641|NCT01818037|"~     Cataract surgery in infantile eyes, which are microphthalmic, can be even more demanding.~      In addition, the frequent presence of other ocular and systemic anomalies such as nystagmus,~     glaucoma, amblyopia, and higher rate of postoperative complications may limit the success of~     cataract surgery.~      In our previous study, the investigators examined the intraoperative performance and~     postoperative outcomes of bilateral cataract surgery in microphthalmic eyes of patients~     before their first birthday. At 1 year, the postoperative results showed that good visual~     outcomes could be obtained in microphthalmic eyes.~      Since only a few studies have reported outcomes, and that too only short term of cataract~     surgery on microphthalmic eyes, in this prospective observational study we evaluated the~     long-term impact of bilateral cataract surgery on eyes with microphthalmos. The investigators~     examined the outcomes, complication rates, influence of age at surgery on pattern of axial~     growth and central corneal thickness and visual and orthoptic assessment in these eyes.~   "
133652|NCT01817894|"~     Split-face investigation of the efficacy of applying Eflornithin cream twice daily for six~     months after a period with six laser treatments for hair removal.~   "
133642|NCT01818024|"~     This will be a 3 part study to investigate the safety, tolerability, pharmacokinetics and~     pharmacodynamics of single and repeat doses of GSK2862277 administered via inhalation (IH) or~     intravenous (IV) routes in healthy subjects.~      Part 1 of this study will involve an initial assessment of safety, tolerability and~     pharmacokinetics of GSK286227, via single escalating intravenous doses, compared to a~     predecessor molecule, GSK1995057. After completion of Part 1 an interim data review will~     occur which will assess key comparability criteria to inform progression to Part 2 of the~     study.~      Part 2 of the study will involve single doses of GSK2862277 at a level predicted to be at or~     close to therapeutic dose levels. Part 2 will investigate both intravenous and inhaled routes~     of administration, in sequential manner, respectively. An interim data review will also occur~     after completion of Part 2, where all data accumulated previously will be assessed to examine~     appropriateness to progress to Part 3.~      Part 3 of the study will involve 5 days of repeat dosing via both inhaled and intravenous~     routes using the same dose administered in Part 2.~   "
133643|NCT01818011|"~     The primary objectives of this study are to assess the safety, tolerability and~     pharmacokinetics of GSK1322322 following intravenous (IV) and oral administration. GSK1322322~     shows broad spectrum antibacterial activity against pathogens involved in respiratory tract~     infections as well as methicillin-resistant S. Aureus (MRSA).~      This study consists of three parts (Part A, Part B and Part C). The results from Part A of~     this study will enable use of large-scale, commercial tablets produced for administration to~     patients in pivotal clinical trials of GSK1322322. The results from Parts B and C will~     support enrolment of Japanese subjects in future clinical studies. Additionally, the results~     will support the dose selection for further clinical development of GSK1322322 in~     hospitalized patients with severe bacterial infections in Japan and other Asian populations.~      In Part A, subjects will undergo screening, 4 treatment periods receiving single dose of each~     of: 1500 mg Initial, fit-for-purpose tablet (product code AP), 1500 mg Over granulated tablet~     (product code AR), and the 1500 mg and 2000 mg of intended commercial tablets (product code~     AU).~      In Part B of the study subjects will undergo screening, and be randomized to receive 3 doses~     of GSK1322322 oral cohort (100 mg, 1500 mg and 2000 mg) or IV cohort (600 mg, 900 mg and 1200~     mg) each in 3 treatment periods.~      Part C will be a single-blind, placebo-controlled, repeat dose study of GSK1322322 in healthy~     Japanese male subjects. GSK1322322 will be administered (fasted) via IV for 4 days BID,~     followed by administration of GSK1322322 orally (fed) for 6 days BID. A follow-up evaluation~     will be conducted 7-10 days following last dose of for each subjects in each Part of the~     study.~      Approximately 12 subjects will be enrolled in each part of the study such that approximately~     8, 6, and 9 subjects complete dosing and critical assessments in part A,B, and C~     respectively.~   "
133644|NCT01817998|"~     Background and study concept:~      Atrial fibrillation is the new global epidemic in cardiology. With improved survival from~     other cardiovascular diseases and longer living in general, the incidence and prevalence of~     AF rise dramatically in all developed countries with an estimated life time risk of one in~     four for all people above the age of 40 years. Similarly in Denmark, the prevalence is~     estimated to almost double within 2020. It is a fatal arrhythmia with doubled mortality~     compared to patients with normal sinus rhythm; this primarily caused by an increased risk of~     stroke and heart failure. In particular stroke is a feared complication with a 70% risk of~     fatal outcome or lasting handicaps and immense costs for each patient as well as in terms of~     health costs.~      Moreover, many AF patients experience a variety of symptoms and have markedly reduced quality~     of life. Opposed to heart failure patients and patients who have suffered from a myocardial~     infarction, AF patients are not offered any sort of rehabilitation when diagnosed.~      Pharmacological treatment of the arrhythmia is challenging. Most often, individual and~     careful risk evaluation including ultrasound of the heart is obligatory to choose optimal~     treatment strategy and prophylactic anticoagulation. In case a new anti-arrhythmic drug is~     started to restore and maintain sinus rhythm, hospitalization for at least two days with~     heart rhythm monitoring is required to detect any possible potentially dangerous or even~     fatal arrhythmia as a side effect to the treatment. Additionally, the first new oral~     anti-arrhythmic AF drug introduced for more than twenty-five years proved to be hazardous in~     a high-risk AF population and is now only used with strict precautions.~      To explore the role of alternative treatment strategies and to renew handling of cardiac~     arrhythmia, we have therefore set out to study the role of physical exercise in AF patients.~      Our specific study aims are to examine:~        1. The effect of physical exercise on AF burden~        2. The effect of physical exercise on the risk of cardiovascular hospitalization~      Method:~      Our study is an interventional, randomized exercise study. 60 patients older than 18 years~     with ECG-documented AF will be included if written informed consent is obtained. They will be~     randomized 1:1 to moderate-severe (80-85% of max capacity) or low intensity (50% of max~     capacity) training. Exclusion criteria are language barrier, illness inherent with an~     expected survival shorter than a year, other reasons preventing the patient from training,~     revealed serious cardiac disease during pre-tests, AF ablation within one year, permanent AF.~      Both groups are first participating in a nurse-led educational and care program. The program~     is built on two individual consultations and one team consultation with focus on education in~     AF.~      The patients will be thoroughly examined before randomization and after ended training period~     with special ultrasound of the heart, ECG-monitored test of maximal oxygen uptake on~     ergometer bicycle, 24 hours measurement of blood pressure and pulse, and blood samples. They~     will all be taught to use home ECG recorders, a new handheld device. The patients will send~     ECG's twice daily and if the experience cardiac symptoms for 5 months (during exercise and~     two months after).~      When randomized the patients will be divided in teams of ten and trained on separate teams,~     so the physiotherapist closely can guide the patients in training at the correct intensity~     level.~      Measurements:~      During and after physical exercise the burden of atrial fibrillation is measured by tele-ECG~     i.e. number of ECGs with atrial fibrillation divided by total number of ECGs. ECG reporting~     begins after four weeks of physical exercise and continues 2 months after last training~     session.~      Recording of hospitalization begins after randomization and continues one year after last~     training session. All hospitalizations caused by AF or related to the AF disease (relapse of~     AF, heart failure, stroke, new anti-arrhythmic medication, elective electrical cardioversion,~     complications to anticoagulation, pacemaker implantation) are recorded. Also, total days in~     hospital are registered.~      The AF population is growing on a global scale and the disease attracts immense interest on~     all international cardiology congresses. New knowledge of the effect of training for the~     general population as well as the effect in the setting of established disease could have~     paramount effect for prognosis, quality of life, and health costs as pharmacological~     treatment is AF still holds challenges.~   "
133645|NCT01817985|"~     This is a Phase 1 Open-Label, Parallel-Group, Single-Dose Study to evaluate the~     Pharmacokinetics of GS-5816 in subjects with normal hepatic function and moderate or severe~     hepatic impairment.~   "
133646|NCT01817972|"~     This is a randomized, double blind trial of combination therapy (Cimzia plus Azathioprine)~     versus mono therapy (Cimzia alone) and the improvement in mean SES-CD (Simple Endoscopic~     Scoring in Crohn's Disease) score.~      It is a trial where the investigators are administering biological therapy by itself and~     biological therapy plus an immunosuppressive medicine in combination to see which form of~     therapy has a better effect on healing ulcerations in the small intestine and colon that are~     due to a flare up of Crohn's disease.~   "
133647|NCT01817959|"~     The chemokine CXCL8 plays a key role in the recruitment and activation of polymorphonuclear~     neutrophils in post-ischemia reperfusion injury after organ transplantion. Reparixin is the~     first low molecular weight blocker of CXCL8 biological activity in clinical development.~     Thus, the use of reparixin may emerge as a potential key component in the sequentially~     integrated approach to immunomodulation and control of non specific inflammatory events~     surrounding the early phases of pancreatic islet transplantation in type 1 diabetes (T1D)~     patients.~   "
133648|NCT01817946|"~     Myotubular myopathy (XLMTM) is an X-linked disorder caused by mutations in the myotubularin~     gene (MTM1). The clinical spectrum is variable and ranges from individuals who require a~     wheelchair and full time breathing support to those who are able to walk and breathe on their~     own. Symptoms of myotubular myopathy include long faces, facial weakness with eye muscle~     weakness, breathing support with a muscle biopsy demonstrating central nucleated fibers.~     These symptoms may be caused by mutations or changes in the MTM1, BIN1 (bridging integrator~     1), DNM2 (dynamin 2) and RYR1 (ryanodine receptor 1) genes. However, the majority are caused~     by mutations in the MTM1 gene. Some patients with symptoms consistent with myotubular~     myopathy who initially have negative testing of the MTM1 gene were later found to have a~     unique type of change in the MTM1 gene. This unique change, called a deletion or duplication,~     can be found with a different type of genetic test called a CGH (comparative genomic~     hybridization) array.~      Investigators do not know how frequent deletions and duplications are in patients with~     X-linked myotubular myopathy. Recently, there have been advances in identifying potential~     treatments for XLMTM. The next step will be to proceed with clinical trials of potential~     treatments. In order to be ready for clinical trials, it is important that investigators find~     the specific genetic change that is causing XLMTM in people with this diagnosis. This study~     will attempt to find changes in the MTM1 gene in individuals who have clinical symptoms~     consistent with a diagnosis of XLMTM. Participants will be asked to enroll in the CMDIR~     (Congenital Muscle Disease International Registry), complete a brief clinical survey, provide~     access to medical records, and provide a saliva or blood sample for genetic testing. Results~     of genetic testing will be communicated to participants by the physician specified in the~     consent by the signing person.~      Study Hypothesis:~      Not all individuals with a clinical diagnosis of XLMTM have access to genetic testing.~     Investigators know that deletions and duplications of the MTM1 gene can cause XLMTM.~     Investigators will find more individuals with XLMTM by performing genetic testing of the MTM1~     gene, including CGH array for deletions and duplications.~   "
133649|NCT01817933|"~     The recovery of range of motion and muscle power after surgical intervention of the fracture~     will mostly affect patient's daily activities. So postoperative rehabilitation program will~     play the important role. Correct and effective physical therapy will reduce the functional~     impairment of limbs after long term casting or surgical fixation, and accelerate to recover~     the independent daily activities. There is no consensus between immediate or delay and the~     duration of continue physical therapy will improve the shoulder function、muscle power and~     degree of satisfaction( physiological function、social function、mental health、 pain、 general~     health status ) after surgical fixation of fractures. This study will evaluate the patients~     of the fracture that including of the humeral neck fracture, vertebral fracture, distal~     radial fracture and hip fractures after surgical fixation, to see the difference of fracture~     healing time, function recovery and pain sensation after intervention of physical therapy at~     different time point.~      From this study, we hope to discriminate the timing of intervention and duration of physical~     therapy which is the key factors for postoperative prognosis of fractures fixation, and to~     set up the perfect rehabilitation program in ChangHua Christian Hospital. The results of this~     study will improve the discomfort of fracture patient's recovery or reduce the complications~     rate, and set up the standard treatment policy of our hospital , also was the model of other~     hospitals.~   "
133700|NCT01817270|"~     The purpose of this study is to observe the occurrence of adverse events, seroconversion rate~     and geometric mean titres(GMTs) of 2 doses of live attenuated varicella vaccine.~   "
133701|NCT01817257|"~     This is a two year, multicentre, mixed methods feasibility study including a randomised~     controlled two-arm interventional trial, a nested qualitative study, focus groups and a~     United Kingdom (UK) wide survey exercise.~   "
133653|NCT01817881|"~     The purpose of this study is to determine whether temporal artery thermometers are accurate~     tools in temperature measurements of patients presenting to the Emergency Department. The~     investigators´ hypothesis is that there is a difference of > 0,3 degrees centigrade~     (Bland-Altman) between the temperatures measured with the temporal artery thermometers used~     at the investigators´ hospital (Exergen TAT-5000) and those measured with rectal thermometers~     (OMRON MC-341-E), which is considered to be the gold standard in Denmark defined by the~     Danish Center for Clinical Guidelines. The investigators furthermore hypothesize that the~     difference between these measurements is greater if measured in a patient with hyperthermia~     (temperature > 37,9 degrees Centigrade).~   "
133654|NCT01817868|"~     The project is an observational, multi-central, prospective, non-interventional and~     open-label data collection study on secondary prophylaxis with recombinant FVIII products in~     adolescents and adults with severe hemophilia A (FVIII < 1%).~      It will be a controlled observation of patients on secondary prophylaxis versus on-demand~     treatment regimen. Patients will be enrolled preferably on a 1:1 basis with regards to~     prophylaxis and on-demand treatment.~      The patient enrollment period will be 2 years with a follow-up (observation period) of 2~     years for each patient. Based on the primary effectiveness parameters (joint bleeds and~     overall bleeds per year) an observation period of 2 years is considered sufficient although~     it has to be admitted that it is rather short to assess the progression of orthopedic status.~     Previously treated prophylaxis patients with at least 50 exposure days and patients with~     continuing prophylaxis treatment will be included.~   "
133655|NCT01817855|"~     This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics~     of multiple ascending doses of AZD7624 in healthy subjects and patients with chronic~     obstructive pulmonary disease.~   "
133656|NCT01817842|"~     This is a study of the effectiveness of mobile phone support for the D.C. Tobacco Quitline.~     The project will test the efficacy of a web-based system that uses mobile phones to improve~     quit rates at 3-month intervals, relative to standard quitline services. Under the standard~     model, relatively infrequent, periodic support is provided to smokers who want to quit and~     seek out the services. The new system will complement that effort by increasing the quality,~     frequency and accessibility of quit smoking support - when and where the smoker needs it~     most. It is hypothesized that successful abstinence rates will improve to the degree that~     participants utilize the support system and engage with the quitline.~   "
133657|NCT01817829|"~     It is a double blinded randomized control trial assessing the use of Oral paracetamol in~     managing the intrapartum pain.~   "
133658|NCT01817816|"~     Spasticity, muscle weakness, abnormal gait pattern are co-morbidities commonly seen in stroke~     patients. They cause disabled condition of patients in activities of daily life and~     functional performance, and also accidental falls and subsequent fractures.~      This study is to evaluate and compare the effects of different phase injection of Botulinum~     Toxin Type-A at affected limbs on muscle rheological changes, muscle activity, muscle tone,~     functional performance, gait pattern and energy consumption in stroke patients.~   "
133659|NCT01817803|"~     To compare the effectiveness and safety of diuretics add-on strategy in chronic heart failure~     patients~   "
133660|NCT01817790|"~     This study is designed to investigate the efficacy of fluticasone propionate (FP) on ocular~     symptoms associated with allergic rhinitis (AR).~   "
133661|NCT01817777|"~     MTF116086 is an open-label, randomised, parallel-design study in subjects with type II~     diabetes. The study is site-based, with local pharmacies serving as the sites and pharmacists~     as principal investigators for the sites. All subjects will enter an initial 8-week~     observational phase during which purchase behaviour and compliance with usual metformin use~     will be observed and recorded. At the end of the observational phase, subjects will be~     randomised to one of the two arms (metformin small pack vs. metformin large pack) for a~     20-week interventional phase. The medication in the interventional phase is provided to the~     subjects free of charge. HbA1c will be collected for all subjects during Week 0, Week 8, and~     Week 28. Subjects will be asked questions about their tablet compliance, their satisfaction~     with the pack size they received and reasons for missing doses throughout the interventional~     phase by the pharmacist. The pharmacy visit on Week 28 will be end of the study.~   "
133662|NCT01817764|"~     This is a multicenter, randomized, double-blind, double-dummy, parallel group study. The~     purpose of this study is to compare the efficacy and safety of umeclidinium/vilanterol~     (UMEC/VI) and fluticasone propionate/salmeterol (FSC) in subjects with COPD. Subjects who~     meet the eligibility criteria at Screening will complete a 7 to 14 day Run-in period. At the~     end of the run-in period, approximately 710 eligible subjects will be equally randomized (to~     complete at least 568 evaluable subjects) to one of the 2 treatment groups for 12 weeks: 1.~     UMEC/VI 62.5/25 micrograms (mcg) administered as one inhalation once-daily in the morning via~     the Novel dry powder inhaler (NDPI) + placebo administered as one inhalation each morning and~     evening via single multidose powdered inhaler (ACCUHALER/DISKUS) or 2. FSC 250/50 mcg~     administered as one inhalation each morning and evening via ACCUHALER/DISKUS + placebo~     administered once-daily in the morning via NDPI. A safety Follow-up assessment will be~     conducted approximately 7 days after the end of the study treatment (Early Withdrawal, if~     applicable). The total duration of subject participation will be approximately 15 weeks.~   "
133663|NCT01817751|"~     This phase II trial studies how well sorafenib tosylate, valproic acid, and sildenafil~     citrate works in treating patients with recurrent high-grade glioma. Sorafenib tosylate,~     valproic acid, and sildenafil citrate may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth.~   "
133664|NCT01817738|"~     The purpose of this study is to determine whether the new RNActive®-derived prostate cancer~     vaccine CV9104 prolongs survival in patients with asymptomatic or minimally symptomatic~     metastatic prostate cancer that is castrate resistant.~   "
133703|NCT01817231|"~     This is an analysis of de-identified data collected from 240 Saudi Arabian women, 120 with~     breast cancer and 120 control women, to evalyate if vitamin D status is associated with~     breast cancer risk.~   "
133885|NCT01814839|"~     The purpose of this study is to determine the safety, tolerability, pharmacokinetics and~     pharmacodynamics of ALN-TTRSC (revusiran) in healthy volunteer subjects.~   "
136176|NCT01784770|"~     To collect retrospectively the efficacy and safety information of azithromycin IV on patients~     with Legionnaires' disease related to their appropriate use in daily practice.~   "
133665|NCT01817725|"~     Background:~      The HBsAg clearance rate in interferon-treated responders is significantly higher than that~     in lamivudine-treated responders, implying immune control is the key to HBsAg clearance.~     There is a good chance to further increase the cure rate if the investigators can enhance the~     HBV-specific immune response when the HBsAg level already comes to a low level.~      Hypothesis: HBsAg-based vaccine can enhance HBsAg clearance in chronic hepatitis B patients~     whose HBsAg already <=2000 IU/ml.~      Patients and methods:~      This pilot study will enroll 20 chronic hepatitis B patients with HBsAg ≦2000 IU/ml, no~     hepatic decompensation, no HIV coinfection, nor clinical immunodeficiency. Engerix-B vaccine~     (20μg for <20 years old and 40 μg for ≥ 20 years old) will be given every 2 months for one~     year. HBsAg quantification, anti-HBs, and HBV DNA will be surveyed regularly before each dose~     during the treatment period and every 3 months for another year following the last dose.~     Viral and cellular factors will be studied to discover determinants affecting HBsAg~     clearance.~      Aims~        1. To elucidate whether HBsAg-based vaccine can reactivate host immunity to eliminate~          chronic HBV infection in patients with low titer HBsAg.~        2. To delineate the doses to response (HBsAg clearance or decline rate) correlation so as~          to design a feasible schedule for future clinical trials in a larger group of patients.~        3. To discover viral and host factors which can be used as biomarkers for personalized~          vaccine therapy.~   "
133666|NCT01817712|"~     The primary objective of CSP#589 VIP-STAR is to evaluate the effectiveness of Individual~     Placement & Support (IPS) in unemployed Veterans with PTSD. The primary hypothesis is that,~     compared to those treated with transitional work program (TWP), unemployed Veterans with PTSD~     treated with IPS will be significantly more likely to become a steady worker. A steady worker~     is defined as holding a competitive job for greater than or equal to 50% of the 18-month~     study follow-up period (i.e., greater than or equal to 39 of the 78 weeks). All participants~     will be followed for 18 months post-randomization.~      12/14/12: Analytic plan augmented to allow for a sensitivity analysis of the primary outcome~     that would exclude the first 12 weeks post-randomization, and evaluate between group~     proportion of steady worker status, as defined by working in a competitive job for greater~     than or equal to 50% of the weeks during week 13-78.~      7/1/13: Analysis plan has been augmented to include a logistic regression analysis of the~     primary outcome, adjusted for participating medical center.~      10/4/13: Addition of the IPS-25 Fidelity Scale. The addition of the IPS-25 scale should~     increase the validity of study results.~      1/15/15: Addition of an Interactive Voice Recognition/Web-based (IVR/Web) System; as an~     option for weekly data capture of the primary outcome data (employment history).~      8/17/15: Approval of Supplemental Data Collection at Participant Study Exit; use of the data~     collected will supplement the study analysis plan and, provide further insight into the~     impact of vocational rehab. A Participant Satisfaction Survey will allow study participants~     to indicate their level of satisfaction with the study, vocational rehabilitation~     intervention and, suggestions for future research.~   "
133667|NCT01817699|"~     The purpose of this study is to evaluate the effect of anemia correction and vitamin D~     supplementation in kidney transplant recipients.~   "
133668|NCT01817686|"~     Default options represent the events or conditions that are set into place if no alternatives~     are actively chosen. The setting of default options has well-established effects on a broad~     range of human decisions, but its influence on patients' preferences for end-of-life care is~     only beginning to be understood.~      This is a 3-armed randomized clinical trial in Veterans at high risk for critical illness,~     assessing the impact of Advance Directive (AD) forms framed with different default options.~     The central goals are to assess how default options in ADs influence the end-of-life care~     choices made by patients at risk for critical care, and these patients' hospital and ICU~     utilization.~      The investigators hypothesize that setting defaults in real ADs will increase the proportion~     of Veterans selecting comfort-oriented plans of care, decrease selections of life-extending~     therapies such as mechanical ventilation and dialysis, and reduce the proportion of time~     during follow-up that Veterans spend in the hospital and/or ICU, without affecting patient~     satisfaction with end-of-life care planning.~   "
133669|NCT01817673|"~     There is a claim that creatine supplementation might affect kidney function, especially in~     those consuming a high-protein diet. The aim of this study was to investigate the effects of~     creatine supplementation on kidney function in resistance-trained individuals ingesting a~     high-protein diet.~   "
133670|NCT01817660|"~     Weakness in the wall of a blood vessel located behind the knee (popliteal artery) which leads~     to a swelling of this blood vessel (aneurysm) is one of the most common types of arterial~     aneurysms. It is associated with significant risk of blood clot formation, narrowing of blood~     vessel which can create a serious threat to individual's health. Currently, approved~     treatment options for this condition include both open surgical and endovascular stent-graft~     repairs.~      In the open repair procedure, the blood vessel behind the knee is tied up or removed and a~     small artery is created using a vein on the same leg. This is also called a bypass procedure.~      In the endovascular repair, using X-rays, doctors places a stent in the blood vessel. Stent~     is a small device similar to a thin tube. When it is placed in the right location, your~     doctor can open it. When stent is opened, it supports weakened blood vessel and blood goes~     through it. The weakened artery then shrinks around the stent.~      The OVER-PAR is a short name for this study. Many hospitals in the United States agreed to~     participate in this study. Patients are randomized to undergo either open or endovascular~     repair because they can be treated with either of the procedures. Investigators use the short~     names OPAR for open surgical repair and EPAR for endovascular repair. People who have an~     aneurysm that is larger than 2 cm (about an inch) can participate in this study.~      The purpose of this study is to compare outcomes after these two standard procedures.~   "
133671|NCT01817647|"~     Procalcitonin (PCT) is a biomarker used to monitor serious bacterial infections and guide~     antibiotic therapy. Anastomotic leak (AL) after colorectal surgery is a severe complication~     associated with relevant short and long-term sequelae. The aim of our study is to assess the~     predictive value of PCT level for early diagnosis of anastomotic leak after colorectal~     surgery.~   "
133713|NCT01817101|"~     The purpose of this study is to determine whether an omega-3 fatty acid supplementation is~     effective in the prevention of progressive cognitive decline in elderly people aged 75 years~     or older.~   "
133672|NCT01817634|"~     New approaches are needed to prevent growth failure in children from low- and middle-income~     countries (LMIC). To date, nutrition intervention studies have focused on micronutrient and~     energy content of complementary foods and have yielded only small to moderate effects on~     growth and development. There appears to be a missing link that mediates and reduces the~     expected beneficial effect. Child populations in LMIC show an asymptomatic environmental~     enteropathy that is characterized by a reduced size of the small intestinal villi, decreased~     gut integrity and a chronic inflammatory response in the gut. Results from studies in~     industrialized countries suggest that ω3 long-chain polyunsaturated fatty acids (ω3 LCPUFAs)~     improve immune response and gut integrity. These reported beneficial effects could result in~     even more important physiological implications for children from LMIC and will ultimately~     contribute to their healthy growth and development.~      The hypothesis of the OME³Jim study is that an increased intake of ω3 LCPUFAs through~     complementary foods and human milk has an effect on infant growth and development in a~     context of high malnutrition rates and low ω3 LCPUFAs intake. This study will identify~     whether intake by either or both mother and infant is more effective.~      The specific objectives of the OME³Jim study are:~        1. To test the effect of supplementing infants with an ω3 LCPUFAs fortified food supplement~          on infant growth, morbidity, nutritional status and development;~        2. To test the effect of supplementing lactating mothers with an ω3 LCPUFAs oil capsule on~          infant growth, nutritional status and development;~        3. To test the combined effect (dose response) of supplementing ω3 LCPUFAs to lactating~          mothers and infant on infant growth, morbidity, nutritional status and development:~        4. To test the effect of ω3 LCPUFAs supplementation on ω3 LCPUFA status in infants and~          human milk.~   "
133673|NCT01817621|"~     The purpose of this study is to develop and test counseling strategies for men who have sex~     with men (MSM) who are living with HIV and are experiencing body dissatisfaction.~      Two phases will be conducted throughout the course of the study.~      Phase 1: Develop an intervention for HIV-infected MSM that addresses body dissatisfaction and~     self-care. (NOTE: currently, only Phase 1 will be recruiting participants, Phase 2 will not~     be active for several months)~      Because of the prospective syndemic relationship between body dissatisfaction and depression,~     the investigator will integrate the most efficacious interventions for body dissatisfaction,~     depression, adherence, and sexual risk reduction, and tailor them to HIV-infected MSM. The~     investigator will then conduct an iterative process of pilots and exit interviews about~     feasibility, acceptability, and the strengths and weaknesses of the intervention until the~     intervention is maximized. Up to 9 participants will be involved in Phase 1.~      Phase 2: Conduct a two-arm randomized control trial comparing the newly developed~     intervention to a treatment-as-usual condition.~      As a first step in addressing the efficacy of the newly developed intervention, the~     investigator plans on randomizing up to 60 participants into either the newly-developed~     intervention or a treatment-as-usual condition. Participants will be assessed at baseline, 3~     months (acute outcome), and 6 months postrandomization. The primary outcome variable is body~     image disturbance. Depression, HIV sexual transmission risk behaviors, and highly active~     antiretroviral therapy (HAART) adherence will serve as secondary outcomes.~      Study hypotheses for the two phases include:~        1. The investigator will be able to develop and implement a feasible intervention that~          integrates addressing and relieving body dissatisfaction with increasing health related~          behavior change in MSM with HIV. Adequate recruitment (at least 80% of goal) and~          retention (at least 80% to follow up) in the trial will be an indicator of success for~          this aim.~        2. Those who receive the intervention will show improvements in health behavior outcomes~          (medication adherence, HIV transmission risk behavior) and will show reduced body~          dissatisfaction and depressive symptoms.~   "
133674|NCT01817608|"~     The investigators objective is to assess quality of life and functional outcome in patients~     requiring short-term mechanical ventilation. Additionally, the investigators plan to measure~     the recovery of peripheral muscle strength and respiratory muscle strength during recovery.~   "
133675|NCT01817595|"~     Background~      With the emergence of the internet, health care professionals are changing the way they~     approach diabetes management. Internet Blood Glucose Monitoring Systems (IBGMS) are aimed at~     keeping blood glucose levels normal or in the range of acceptable levels to prevent the~     complications associated with diabetes. The Principal Investigators have completed a~     randomized clinical trial supporting the efficacy of IBGMS (1,2).~      Patient satisfaction of reporting platform is essential to encourage patient reporting and~     participation in IBGMS. In this study, we wish to compare two different types of meters which~     will be used to internet blood glucose monitoring: the BG Star Meter (Conventional Meter),~     and the iBG Star Group (iPhone Technology).~      Purpose and Rationale~      Patients who are more satisfied with their meter and internet reporting platform are more~     likely to participate in an internet monitoring system. Patients often lack the motivation to~     report to their endocrinologist. With increased reporting to their healthcare professional,~     patients are more likely to benefit from such a system. This study aims to compare two types~     of meters and their respective internet reporting platforms to encourage patient~     participation.~      Objectives~      Our main goal is to compare the two types of meters.~      Primary Outcomes Include:~        1. Patient Satisfaction as measured by the Diabetes Treatment Satisfaction Questionnaire~          (DTSQ)~        2. Frequency of reporting to endocrinologist~        3. Number of Self-Monitoring Blood Glucose (SMBG) tests~        4. Time taken to teach each patient the platforms~      Research Design/Methods~      Sample Size: 50 patients will be randomized into two groups:~      BG Star Group (Conventional Meter) 25 patients will use the (conventional) BG star meter in~     which patients will upload their readings onto a computer and send in their readings via~     email.~      IBG Star Group (iPhone Technology) 25 patients will be randomized to the iBGstar system will~     upload their readings to their iPhone and send in their readings using the iPhone.~      Patients will be recruited from a Physician's private office.~      Both the (Conventional meter) BG star and iBG star (iPhone Technology) group will be asked to~     perform SMBG 3 or more times per day and to upload their metered glucose values online every~     2 weeks to be reviewed by the doctor.~      Inclusion criteria:~        -  Type 1s~        -  Type 2s, can be on insulin, oral antihyperglycemic agents, or in combination.~        -  Willingness to test blood glucose levels a minimum of 3 times daily~        -  Willingness to be randomized~        -  Trained in self-blood glucose monitoring~        -  Internet Access~      Exclusion criteria: Patients who do not meet the above criteria or are not willing to~     participate will not be included in the study.~   "
133676|NCT01817582|"~     This study is being conducted to investigate the safety, comfort, and tolerability of 3~     treatments: Lotemax® gel 0.5% administered twice daily (BID)with or without Restasis 0.05%~     administered BID, and Restasis 0.05% treatment alone for 12 weeks and at a follow-up safety~     visit 1 week post-treatment. This study will also investigate the relative efficacy of~     Lotemax gel 0.5% administered BID with or without Restasis 0.05% treatment administered BID~     and of Restasis 0.05% treatment alone for the reduction of clinical signs or symptoms of~     keratoconjunctivitis sicca (DED) over the first 4 weeks of a 12-week Treatment Period and at~     the end of a 12-week Treatment Period.~   "
133677|NCT01817569|"~     The purpose of this investigation is to describe general safety profile of type II Diabetes~     Mellitus (DM) Japanese patients under exenatide therapy in real world medical practices~   "
133678|NCT01817556|"~     This is a multicenter, active-controlled, randomized, double-blinded, paralleled group~     clinical study to evaluate the efficacy of 4-week treatment with Stillen tab. in patients~     with acute or chronic gastritis. Subject will receive Stillen tab or Mucosta tab., three~     times a day for four weeks.~   "
133679|NCT01817543|"~     The aim of this trial is to demonstrate the effectiveness of complete wound healing in a~     prospective, open-label, cohort-controlled trial in which venous leg ulcers (VLU)n will be~     treated using AutoloGel and case-matched against a concurrent cohort of patients receiving~     undefined Usual and Customary Care (UCC)~   "
133680|NCT01817530|"~     This is a Phase 2b randomized, double-blind, placebo-controlled study evaluating the safety~     and efficacy of elagolix alone and in combination with add-back therapy versus placebo on~     heavy menstrual bleeding in premenopausal women 18 to 51 years of age with uterine fibroids.~   "
133681|NCT01817517|"~     This research is being performed to try to understand if the use of deep brain stimulation or~     DBS can treat the symptoms of Tourette syndrome that do not respond well to current~     medications. In order to do this the investigators will place small stimulation leads on both~     sides of the brain in a region (a portion of the thalamus) that may alter the abnormal~     activity in the brain contributing to the symptoms of Tourette syndrome. This requires two~     surgical procedures, and several preoperative and postoperative visits for tuning the~     stimulation parameters and recording stimulation effects. The FDA has not approved DBS for~     use in people with Tourette syndrome, and Medtronic (the manufacturer of the device) has not~     conducted testing for the system in Tourette syndrome. Therefore its use in this study is~     experimental.~   "
133682|NCT01817504|"~     Our hypothesis is early and systematic transplantectomy under a well-conducted~     immunosuppression is associated with a decreased risk of anti-HLA immunization against a~     conservative attitude including a gradual reduction of immunosuppression, with or without a~     transplantectomy performed for cause (clinical event).~      Observation or Investigation Method Used :~      The study is :~        -  multicenter~        -  prospective~        -  open~        -  randomized: patients are divided into two parallel groups:~             -  study group: transplantectomy within six weeks after return to dialysis,~               antiproliferatives stop at the start of dialysis, Maintenance~               anticalcineurin-based-immunosuppression without dose reduction up to two weeks~               after transplantectomy. Abrupt discontinuation of anticalcineurin two weeks after~               transplantectomy. Corticosteroids: 5mg per day until one month after~               transplantectomy then stop within one month.~             -  control group: No systematic transplantectomy. Antiproliferatives stop at the start~               of dialysis.Anticalcineurins half dose for 3 months, ¼ dose for 3 months and then~               stop. Corticosteroids:5 mg per day for 6 months, and then tapered and stop within 3~               months.~      In the case of transplantectomy for cause in the control group, immunosuppression will be~     continued at the maintenance dose during the current surgical procedure, and withdrawn two~     weeks later,similary to systematic transplantectomy.~   "
133683|NCT01817491|"~     The purpose of this study is to investigate the short-term effects of a reduced fat~     plant-based diet on biomarkers of inflammation, oxidative stress and cardiovascular risk.~     This plant-based diet consists of whole grains, fruits and vegetables and little amounts of~     nuts and seeds, with no limitations on the amount of food intake. Animal products are not~     allowed. The results of the plant-based diet will be compared with the diet recommended by~     American Heart Association. This diet also emphasizes fruits and vegetables, but allows~     healthy fats, low-fat meats, fish and low-fat dairy in moderation. The results of the study~     might be useful in understanding whether or not plant-based diets are protective against~     cardiovascular disease.~   "
133684|NCT01817478|"~     The investigators want to find out if there is any difference between the microbiotic flora~     lining the conjunctiva of medical staff that work in the hospital and others who do not work~     in the hospital.~   "
133685|NCT01817465|"~     This is a phase IV , comparative study to evaluate the efficacy and safety of Motiltone® in~     treatment of the patients with functional dyspepsia. The study is conducted with following~     methods: multi-centers, double blind, randomization, parallel. The subjects will receive~     Motilitone® or/and Pantoline®.~   "
133686|NCT01817452|"~     Trial to evaluate efficacy of dual blockade with two anti-HER2 agents with or without~     chemotherapy backbone within the ADAPT trial.~   "
133687|NCT01817439|"~     Atrial fibrillation (AF) remains a significant contributor to cardiovascular morbidity.~     Amiodarone is a potent antiarrhythmic drug; however, patients receiving IV amiodarone are at~     high risk for phlebitis. Phlebitis may lead to infection, additional medical intervention,~     delay in treatment, and prolonged hospitalization. Therefore, examining new therapy approach,~     aimed to reduce the incidence of phlebitis is a valuable clinical and research goal.~      Aim: To evaluate the safety and efficacy of oral versus intravenous (IV) Amiodarone in the~     treatment of AF of recent onset (duration < 48 h).~   "
133688|NCT01817426|"~     The purpose of this study is to determine whether infliximab can favourably and safely be~     discontinued in patients with Crohn's disease in sustained complete clinical, biochemical,~     and endoscopic remission on infliximab.~      Further to examine the clinical utility of measuring levels/activity of infliximab and~     activity of anti-infliximab Ab in patients in sustained complete remission, in order to~     investigate whether pharmacoimmunological data can predict the clinical outcome and~     rationalize therapeutic management of these patients with respect to continuation or~     discontinuation of infliximab therapy. Additional, to investigate the optimal time-point, out~     of three, to measure this activity.~   "
133689|NCT01817413|"~     Children often damage their front teeth. In approximately 6% of cases, the nerve inside the~     affected tooth dies (becomes 'non-vital') and natural root development stops. In these cases,~     the tooth requires a root canal treatment in order to prevent problems such as pain and~     dental abscesses from arising. However, because the roots of these young teeth are not fully~     formed, they are weaker and prone to fracture. In addition, root canal treatment is difficult~     because a root canal filling cannot be placed in a tooth which is not yet fully formed, due~     to the fact that the root has an 'open' end.~      To enable root canal treatment to be carried out, a 'barrier' must be placed at the end of~     the 'open' root. This can be done using materials called Calcium Hydroxide or Mineral~     Trioxide Aggregate (MTA). These materials are placed inside the root and sealed into the~     tooth. However, although they help to provide a barrier, they do not help to strengthen the~     walls of the root. Treatment with these materials requires multiple visits to the dentist,~     over a period of up to 18 months.~      There is evidence to suggest that an alternative treatment involving 'revascularisation'~     (recovery of the blood supply to the tooth) and the use of a triple antibiotic paste allows~     'natural' root growth to restart, and also strengthens the walls of the root. Treatment can~     often be carried out in just two visits.~      The aim of this study is to discover whether there is a difference between one of two methods~     of treating non-vital teeth with open ends. It is thought that there will be no significant~     differences seen between the results of the two techniques.~      Children with teeth that fall into this category and require root canal treatment will be~     given one of two treatments, both of which aim to treat infection, close the root end and to~     allow healing to take place.~      Teeth will receive one of the following methods of root treatment:~        1. Revascularisation (recovery of the natural blood supply to the tooth) following~          placement of an antibiotic paste into the tooth root. The aim of this treatment is to~          allow 'natural' root growth to restart. Root growth will allow the tooth to form at~          barrier at the end of the root. No root canal filling will then be necessary.~        2. Closure of the open root end by placement of an artificial barrier at the end of the~          root so that a root canal filling can then be placed. This will be done with a dental~          material called Mineral Trioxide Aggregate (MTA). Non-vital teeth with an open end are~          routinely treated in this way at Liverpool Dental Hospital.~   "
133690|NCT01817400|"~     The study is seeking to understand how being overweight and obese makes women less fertile.~     The studies the investigators have done so far indicate that there is a hormone or other~     substance produced by fat that goes into the blood and reduces reproductive hormones in women~     who are overweight and obese. The present study will try to find the most promising~     substances by studying small numbers of women and trying to remove the substances that are~     causing the problem.~      Hypothesis: A circulating factor or factors, either hormonal, inflammatory or metabolic,~     causes relative pituitary hypofunction and correction of this reproductive deficit will allow~     obese women with infertility who have failed to reduce their body weight to normal to~     conceive, and may also prevent the horizontal passage of an adverse metabolic phenotype to~     the offspring.~   "
133751|NCT01816607|"~     The purpose of this study is to establish a reliable method for detection of rectal cancer~     patients with aggressive tumor at risk of metastatic disease and death by functional MRI.~   "
133752|NCT01816594|"~     This randomized, parallel cohort, two stage, double-blind, placebo-controlled study will~     evaluate the oral PI3K inhibitor BKM120 in combination with trastuzumab and paclitaxel in~     HER2-positive primary breast cancer prior to definitive surgery (neo-adjuvant setting).~   "
133691|NCT01817387|"~     This project will result in the development of a personalized intervention strategy to~     improve motivation for treatment engagement and functional outcomes in individuals with a~     recent onset of schizophrenia. Motivational impairment is arguably the single most important~     factor that determines a patient's ability to engage in and adhere to effective treatment. In~     our study, sixty participants will be enrolled in a randomized controlled trial comparing the~     feasibility and tolerability of two types of motivational interventions (Daily Goals or~     PRIME), and a neuroplasticity-based cognitive training program. Participants are randomized~     to either receive Daily Goals or PRIME for 8 weeks, after which, both conditions will also~     receive an 8-week course of cognitive training delivered via iPads. Participants will undergo~     pre/post-testing and a 6-month follow-up to determine feasibility and efficacy of the~     interventions. By enhancing motivation, schizophrenia patients would be able to engage more~     fully with treatment and develop full and productive lives. This study may also pave the way~     forward for other health conditions in which motivational impairments impede health outcomes.~      All assessments will be conducted at the University of California, San Francisco; however, we~     offer some assessments to be done remotely.~   "
133692|NCT01817374|"~     1. Evaluate quantitative VCEUS imaging for determining early breast cancer response to~          neoadjuvant chemotherapy and compare results to co-temporal volume change on grayscale~          ultrasound and post-treatment mammography findings utilizing final surgical pathology~          and clinical outcome.~        2. Assess incremental benefit of quantitative VCEUS to planar CEUS tumor perfusion~          measurements and enhancement patterns in predicting tumor response to adjuvant treatment~          in clinical studies.~      The contrast agent Definity® is FDA approved for use as a contrast agent during ultrasound~     (echocardiography) of the heart. Definity® will be used off-label (during ultrasound of the~     breast) in this study. The administration of Definity® during this study will follow total~     dose guidelines approved by the FDA.~   "
133693|NCT01817361|"~     The public health impact of this study will be the application of the greater understanding~     of the oral health status, oral health related behaviors, and quality of life of patients~     with systemic sclerosis (scleroderma or SSc). It is hoped that risks and protective factors~     can be identified to be associated with the oral health status of adults with systemic~     sclerosis,leading to the development of interventions for improved oral health in this~     population,and providing the basis for a larger study of oral health problems of adults with~     systemic sclerosis.~   "
133694|NCT01817348|"~     1. Therapeutic exercise, especially stretch exercise and joint mobilization, remain the~          mainstay of conservative treatment of frozen shoulder.~             1. Nevertheless, shoulder pain during the physiotherapy reduces the treatment effect.~             2. Manipulation or arthroscopic release under general anesthesia may avoid pain during~               the intervention; however, increased risk of humeral shaft fracture and failure of~               release of pathological tissue were reported.~        2. We consider intra-articular injection is a compromized way, from a practical point of~          veiw, to reduce the pain during physiotherapy.~        3. We hypothesize that, intra-articular injection with lidocaine before joint mobilization~          and stretch exercise, can make the patient pain-free during physiotherapy, and the~          effect of combined therapy is superior to physiotherapy alone in the treatment of frozen~          shoulder.~   "
133695|NCT01817335|"~     This pilot clinical trial studies psycho-educational program in increasing knowledge and~     satisfaction and decreasing distress in younger patients with cancer receiving treatment.~     Psycho-educational program may increase knowledge and satisfaction and decrease distress in~     younger patients with cancer receiving treatment~   "
133696|NCT01817322|"~     To demonstrate that cyclosporine-sparing immunosuppressions with the standard dose of~     Enteric-Coated Mycophenolate Sodium would preserve renal graft function after transplantation~     without an increase of incidences of adverse events, such as biopsy confirmed acute~     rejection, local or systemic infections, and bone marrow suppression.~   "
133697|NCT01817309|"~     Peritoneal dialysis (PD) is the first-line treatment of end stage renal disease (ESRD) in~     Hong Kong. Despite the advances in antibiotic therapy and connecting system, recurrent~     peritonitis remains the major cause of peritoneal failure. A reliable predictor of relapsing~     peritonitis is invaluable in the management of PD peritonitis. Recent studies showed that~     bacterial-derived lipopolysaccharide (LPS) fragments are present in clinically used fluids~     such as dialysis fluid. LPS are thought to be derived from microorganisms inhabiting body~     fluid. The investigators hypothesize that the presence of LPS in PD effluent is a predictor~     of relapsing peritonitis in PD patients. The investigators plan to study 300 patients with PD~     peritonitis. After inform consent, specimens of PD effluent will be collected on the day of~     initiating antibiotic treatment, every 5 days until the day of completing antibiotic~     treatment, and then 28 days later for the test of LPS level. All patients will be followed~     for one year after completion of antibiotic therapy for the development of relapsing,~     recurrent, or repeat peritonitis episodes. Our study would explore the use of detecting LPS~     in PD effluent as a non-invasive tests for the prediction of relapsing peritonitis.~   "
133698|NCT01817296|"~     Klinefelter syndrome occurs in 1 in 600 males and is a common cause of infertility in men. It~     appears scar tissue forms in these boys' testicles, leading to progressive destruction over~     their lifetimes. Advanced reproductive technology can be used to surgically retrieve sperm~     from these individuals, but these methods have a 50% failure rate in adult Klinefelter~     patients. Younger men have higher success rates, suggesting that adolescence and young~     adulthood may be the best time to extract sperm, but these techniques have not been studied~     in Klinefelter patients younger than 26 years of age. Additionally, there is currently no way~     to predict which Klinefelter patients will have success with these methods and which of them~     will not. This trial will explore sperm extraction in Klinefelter syndrome in an age range~     (12-25 years) that has never been studied, with the ultimate hope of improving the potential~     for fertility in these patients. The specific goals of this study are to determine the ideal~     age for sperm retrieval in Klinefelter patients and to establish factors that can be used to~     predict which of these patients will have a higher likelihood of success with advanced~     reproductive technology. The hypothesis is that younger Klinefelter patients will have higher~     sperm retrieval rates.~   "
133699|NCT01817283|"~     This study is a prospective, multicenter, randomized, placebo-controlled clinical trial, to~     evaluate impact of Triptolide wilfordii on T cell immune activation and inflammation~     biomarkers in HIV-infected immunological non-responders.~   "
133704|NCT01817218|"~     INTRODUCTION: Vascular ulcers are an important pathology in the daily medical practice in all~     the assistance levels, and they have big repercussion referring to individual, social and~     labour levels, supposing a big consumption of human and material resources.The cure with~     autologous platelet rich plasma (autologous PRP) has demonstrated in different studies a~     decrease in the cicatrization time comparing to conventional methods in hospital levels,~     which becomes interesting contrasting its efficacy in primary care.~      AIM:Evaluate the practicability, security and potential of the autologous PRP in the~     treatment of vascular ulcers, comparing to the conventional treatment ( cure with humid~     environment), in primary care patients with chronic venous insufficiency in C-6 degree (CEAP~     classification).~      DESIGN:A pilot study will be executed, which will consist in a randomized clinical test,~     multicentred, in parallel groups and opened. 40 patients suffering of venous vascular ulcers~     will be studied, who will be between the age of 40-80 years old, and who will be attached to~     five health centers. Variables for the identification, following, result and patient profile~     have been defined. Emphasize the variables of ulcer area decreasing, CIVIQ index, % one~     cure per week .~   "
133705|NCT01817205|"~     The objective is to evaluate the safety and therapeutic effect of combined hyperthermia and~     TACE for unresectable HCC~   "
133706|NCT01817192|"~     The optimal treatment for stage I non-small cell lung cancer (NSCLC) remains controversial.~     Radiographic surveillance alone has been recommended for stage I patients after the tumor is~     removed surgically from the lung, and this standard has been based on the fact that no~     previous clinical trial has demonstrated a benefit for stage I NSCLC patients who receive~     post-operative chemotherapy. These patients, however, have a substantial risk of death within~     five years after operation, ranging from approximately 30% to 45%, largely due to metastatic~     disease that is present immediately after surgery but that is undetectable by conventional~     methods. Some leading organizations therefore currently recommend post-operative chemotherapy~     as an alternative standard of care in stage I NSCLC patients who are considered to be at~     particularly high-risk. Up until now, however, there has not been a well-validated means to~     identify stage I NSCLC patients at high risk of death within five years after operation. A~     new prognostic tool, the Pervenio™ Lung RS Assay, which has been validated and definitively~     demonstrated in large scale studies to identify high-risk stage I patients with non-squamous~     NSCLC, is now available to all clinicians through a CLIA-certified laboratory. It is~     therefore now possible to compare the outcomes of patients randomly assigned to one or the~     other of these competing standards of care.~   "
133707|NCT01817179|"~     The purpose of this study is to evaluate how a functional electrical stimulation (FES) device~     worn on the lower leg effects how children (ages 6-17 years) with hemiplegic cerebral palsy~     walk and perform other functional activities.~      The investigators expect to find that wearing the functional electrical stimulation device~     will improve walking and other functional activities of children with hemiplegic cerebral~     palsy. Participants will be trained in use of the device and will be required to wear it~     daily for 3 months. Each participant will be evaluated before beginning the intervention and~     after completing the intervention. This study will provide important information regarding~     the benefits of this treatment intervention in children with hemiplegic cerebral palsy.~   "
133708|NCT01817166|"~     The main objective of this study is to evaluate the efficacy and tolerance of 2 years of~     treatment with cholecalciferol (vitamin D3) in patients with a clinically isolated syndrome~     at high risk for MS (CIS).~   "
133709|NCT01817153|"~     The main objectives of the study are 1)to examine the immediate (2 hours) and delayed (8~     hours) effects of intravenous hydrocortison on macro and microvascular post-ischemic~     vasoreactivity, in septic shock adult patients; 2) to examine possible correlations between~     post-ischemic flow-mediated dilation (FMD) of the brachial artery (assessed by ultrasound~     imaging) and post-ischemic recovery slope of the thenar oxygen saturation (StO2) (assessed by~     near-infrared spectroscopy).~   "
133710|NCT01817140|"~     The primary objective of this study is to improve the diagnostic accuracy and specificity of~     MRI in detecting the degree of bone involvement and invasion in oral cancer. The presence and~     degree of bone invasion determines the extent of surgery and has great effect on the~     morbidity of patients with oral cancer and bone/soft tissue tumors.~      MRI scanning in 3 Tesla (3T) and 4Tesla (4T) MR magnet will be performed on up to 10 patients~     with possible maxillofacial and/or mandibular bone invasion. We will then compare the~     conventional imaging results of the patients with 3T and 4T MRI results and post operative~     pathology results.~   "
133711|NCT01817127|"~     This observational study is designed to determine how sugars, lipids and proteins in breast~     milk vary among mothers; is affected by maternal diet, health and microbiota and vary over~     the course of lactation. Additionally, the study is designed to determine how the structure~     and composition of complex milk sugars, maternal health status and diet influence the~     development and maintenance of infant gut microflora.~   "
133712|NCT01817114|"~     During a heart attack, an artery carrying blood and oxygen to the heart becomes blocked,~     which causes damage to the heart muscle. When possible, a clot-busting drug is given or a~     procedure called angioplasty is performed soon after a heart attack starts, to open up the~     blocked artery and restore blood flow to the heart. While this can be an effective treatment~     to reduce permanent damage to the heart, patients can still experience heart failure~     afterwards. Consequently many patients require medications to support their heart after a~     heart attack. Recent research has shown a new technique called Remote Ischemic conditioning~     or RIC, is effective at protecting the heart muscle in a heart attack. RIC is produced simply~     by repeated inflation and deflation of a blood pressure cuff on an arm or leg to temporarily~     cut off and then restore blood flow to that limb. The investigators believe this triggers the~     release of molecular factors that protect heart muscle. In a recent study in humans, it~     reduced the amount of permanent damage to the heart muscle when applied before the~     angioplasty procedure. The investigators recent animal studies have shown that RIC may also~     help the heart muscle recover after a heart attack if applied everyday during the month after~     a heart attack, by preventing heart failure. This is important for two reasons: first,~     currently the investigators can only treat heart failure with medications, and second, some~     people have heart attacks but are not suitable to have angioplasty and so are at greater risk~     of heart failure. Daily RIC may provide an easy and effective new treatment to prevent heart~     failure after a heart attack. This application proposes a preliminary study in humans to see~     if daily RIC can help heart muscle recovery after a heart attack.~   "
133714|NCT01817088|"~     Deep brain stimulation (DBS) is an established procedure for the symptomatic treatment of~     Parkinson's disease. This procedure performed in two steps using electrophysiology. This~     study is a prospective, randomized and monocentric study to compare two DBS procedures with~     or without electrophysiology.~      A better control of targeting and trajectory is necessary before not using electrophysiology,~     which is the reference procedure. A new definition of sub thalamic nuclei with new MRI~     stereotactic landmarks, the use of surgical robot (Neuromata Renishaw) and the use of~     operative imaging (O-arm) could allow the implantation of electrode in sub-thalamic nuclei~     without the need of electrophysiology.~      Two groups of patients will be followed: a first group of patients with a procedure under~     general anesthesia alone without electrophysiological stimulation and a second smaller group~     of patients with a first step of electrode implantation under awake surgery with~     electrophysiological stimulation followed by a second step under general anesthesia for the~     implantation of stimulator.~      Clinical results will be assessed at 6 months after implantation.~   "
133715|NCT01817075|"~     This randomized phase III trial studies chlorhexidine gluconate cleansing to see how well it~     works compared to control cleansing in preventing central line associated bloodstream~     infection and acquisition of multi-drug resistant organisms in younger patients with cancer~     or undergoing donor stem cell transplant. Chlorhexidine gluconate may help reduce bloodstream~     infections and bacterial infections associated with the central line.~   "
133716|NCT01817062|"~     Objective:~      Due to high mortality rates the capillary leakage and the acute abdomen are important risk~     factors of the probability of survival. The aim of an optimal therapy of the acute abdomen~     within the neonatal period is beside the cure of the underlying disease the prophylaxis of~     capillary leakage with the help of optimised intra- and postoperative volume therapy.~      Question:~      Do the neonates with very low birth weight and a surgery therapy of acute abdomen benefit~     from early increase of the haemoglobin/haematocrit by optimised volume therapy with~     crystalloid and colloidal volume as prophylaxis of the capillary leakage?~   "
133717|NCT01817049|"~     Soccer accounts for more than 10% of all sport injuries in youth requiring medical attention.~     The injury rates in youth soccer where there is no established injury prevention program are~     estimated at 22-30 injuries/100 participants/year, or 3.4-5.6 injuries/1000 participation~     hours. Risk reductions ranging from 32-43% have been found for youth players participating in~     neuromuscular training programs, such as the FIFA 11+, that include agility, balance~     training, and strengthening components. Although studies have shown that the FIFA 11+ is~     effective at reducing injuries, there is poor uptake of the program in the youth soccer~     community. It is therefore important to develop ways of delivering the program to soccer~     coaches and players in order to maximize its protective benefit. The Health Action Process~     Approach (HAPA) is a behavior change theory that has been used to successfully predict the~     uptake of health behaviours in a number of populations, such as cancer screening and~     exercise, but has not been tested in sport injury prevention settings.~      The primary objective of this study is to examine the effect of a HAPA-based coach education~     intervention on adherence to the FIFA 11+ in a group of female youth soccer players over the~     course of one outdoor and one indoor season. The secondary objective is to examine the~     dose-response relationship between program adherence and injury, comparing program adherence~     and injury rates in outdoor and indoor soccer. Our hypothesis is that teams whose coaches~     receive a HAPA-based intervention will have greater adherence to the program than teams whose~     coaches do not receive the intervention, and that that injury incidence will decrease as~     adherence to the program increases. It is expected that program adherence will be lower and~     injury rates will be higher in indoor soccer compared to outdoor soccer.~   "
133718|NCT01817036|"~     To determine the dose-response between the doses of vitamin D3 supplements and raised serum~     levels of 25(OH)D and also the dose of vitamin D3 required to achieve circulating 25(OH)D ≥~     75 nmol/L;~   "
133719|NCT01817023|"~     The purpose of this study is to verify that simultaneous integrated boost IMRT (SIB-IMRT)~     alone is non-inferior to SIB-IMRT combined with concurrent chemotherapy for low-risk locally~     advanced nasopharyngeal carcinoma.~   "
133720|NCT01817010|"~     To determine if patients who receive an 8 week, comprehensive, multi-component rehabilitation~     program (CMC) have better strength and functional performance compared to a control group~     (CON).~      The investigators hypothesize that functional performance and strength in the muscles~     surrounding the hip and the knee will be greater in the multi-component rehabilitation group~     compared to the control group.~   "
133721|NCT01816997|"~     Evaluate the effects of rosuvastatin (maybe the highest diabetogenic) and pravastatin (seems~     to be protective) on the glucose homeostasis and other biomarkers in subjects with impaired~     fasting glucose.~   "
133722|NCT01816984|"~     This pilot randomized phase I/II trial studies the side effects and best dose of PI3K~     inhibitor BKM120 when given together with cetuximab and to see how well it works in treating~     patients with recurrent or metastatic head and neck cancer. PI3K inhibitor BKM120 may stop~     the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal~     antibodies, such as cetuximab, can block tumor growth in different ways. Some block the~     ability of tumors to grow and spread. Others find tumor cells and help kill them or carry~     tumor-killing substances to them. Giving PI3K inhibitor BKM120 together with cetuximab may~     kill more tumor cells~   "
133723|NCT01816971|"~     This phase II trial studies how well carfilzomib, lenalidomide, and dexamethasone before and~     after stem cell transplant works in treating patients with newly diagnosed multiple myeloma.~     Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for~     cell growth. Biological therapies, such as lenalidomide, may stimulate the immune system in~     different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as~     dexamethasone, work in different ways to stop the growth of cancer cells, either by killing~     the cells or by stopping them from diving. Giving carfilzomib, lenalidomide, and~     dexamethasone before and after stem cell transplant may kill more cancer cells~   "
133724|NCT01816958|"~     application of external neuromodulation along with ketamine infusion.~   "
133725|NCT01816945|"~     The investigators' mobile application-based community, termed Momba, will provide a~     bi-directional flow of information on maternal and infant mental health to traditionally~     underrepresented groups of mothers and their infants. The overall goal of this mobile~     application-based community of low-income postpartum women and infants is to increase the~     social support, social networks, and social capital of low-income mothers; thereby, leading~     to a positive change in the health behaviors, utilization of health services, and mental~     health status of both mothers and their infants.~   "
133779|NCT01816243|"~     The purpose of this study is to evaluate the efficacy and safety of Transdermal Therapeutic~     System (TTS)-fentanyl patch (transdermal patch containing a drug that is put on the skin so~     the drug will enter the body through the skin) in Thai participants with chronic (lasting a~     long time) non-malignant (non-cancerous) pain.~   "
133726|NCT01816932|"~     This is a pilot study in which women who desire an etonogestrel implant will be randomized to~     either a home or office insertion visit. The purpose of this research is to study the~     interest in, feasibility of, and rates of insertion for implantable birth control~     (Implanon®/Nexplanon®) when inserted at home visit appointments compared to standard office~     visit appointments.~      The ultimate goal of the study is to reduce barriers to insertion of the etonogestrel implant~     and increase consistent and correct contraception use by introducing a previously unexplored~     method of access, the home visit.~   "
133727|NCT01816919|"~     Head and neck tumors are common in the general population especially in high risk groups of~     smokers and alcohol abusers, as well as after exposure to various environmental factors.~     Diagnosis is based on identification of patients gross disease after a physical examination~     and various imaging methods, and characterization of tissue mainly by fine-needle puncture~     (FNA) and biopsy. Determining the stage of disease is based on physical examination, imaging~     and tissue samples.~      Using the electronic nose technology we hope to identify microscopic disease when it is~     suspected or in populations in risk, thus diagnose patients in the initial stages of the~     disease. Obviously, early diagnosis and treatment decisions will hopefully improve the~     prognosis.~      Finding a positive correlation between the stages, levels and various tumor volume and~     respiratory specimens findings will classify patients more accurately and contribute to~     further characterization of the disease in a more accurate, rapid and non-invasive fashion.~   "
133728|NCT01816906|"~     This particular trial is looking to compare the effectiveness of two types of foot bed/ sole~     materials used within diabetic footwear.~   "
133729|NCT01816893|"~     The goals of this proposal are to determine the effects of hypoglycemia on the autonomic~     nervous system.~   "
133730|NCT01816880|"~     The aim of this sub-study is to determine whether healthy individuals over 90 years of age~     possess immune cells that are involved in protection from chronic disease. The immune system~     is well known to produce anti-cancer and other immune cells, called antibodies that can be~     beneficial to our health. In this study the investigators will evaluate the immune status of~     the healthy individuals over 90 years of age. The investigators will be focused on studying~     molecules known to be involved in cholesterol, cancer like those for prostate cancer and~     breast cancer, inflammatory diseases, and infectious diseases like influenza.~   "
133731|NCT01816867|"~     The purpose of the registry is to evaluate safety and efficacy of the Intramesh T1. This~     registry will collect data from 100 patients treated for a ventral hernia repair.~   "
133732|NCT01816854|"~     In this prospective study, a newly developed self-expanding nitinol stent is evaluated for~     the treatment of atherosclerotic lesions in the superficial femoral artery.~   "
133733|NCT01816841|"~     This clinical trial studies direct visual fluorescence in finding oral cancer in high-risk~     patients and patients undergoing routine dental care. Diagnostic procedures, such as direct~     visual fluorescence, may help find and diagnose oral cancer.~   "
133734|NCT01816828|"~     Gay Poz Sex (GPS) is a peer-facilitated holistic sexual health program for gay and bisexual~     HIV-positive men. Groups of five to eight men attend eight weekly sessions which cover basic~     sexual health information, review the current legal context surrounding HIV non-disclosure~     and use motivational interviewing (MI) to support participants in setting and achieving~     personal goals.~      In this randomized control trial phase of the research, the investigators are assessing the~     efficacy of the group counseling intervention, GPS. Participants are randomized to receive~     GPS immediately or to a wait list/standard of care condition. Participants are followed for a~     6 month period and are asked to complete baseline quantitative assessments, as well as two~     qualitative interviews.~   "
133735|NCT01816815|"~     Effects of BAY1002670 on bleeding pattern: non-bleeding rate; on endometrium; on ovarian~     function; return of menstrual bleeding after treatment; safety and tolerability; PK/PD~     (pharmacokinetic/pharmacodynamic) relationship~   "
133736|NCT01816802|"~     The purpose of this study is to record and evaluate the use of traditional morphology grading~     combined with Eeva in the treatment of in vitro fertilization.~   "
133737|NCT01816789|"~     This randomized controlled trial has been designed for carrying out a comparison of new AMH~     (Anti-Müllerian Hormone)-based individualized treatment (using a nomogram) with the wide~     accepted age-based strategy. The main objective of the trial is to assess whether an~     individualized FSH starting dose can increase the rate of women with an adequate ovarian~     response in terms of retrieved oocytes (optimal number of retrieved oocytes: 8-14).~   "
133738|NCT01816776|"~     The primary purpose of this prospective, multicenter, randomized trial is to evaluate the~     safety and effectiveness of therapy delivered by the remedē® system in subjects with moderate~     to severe central sleep apnea and optimal medical management, compared to outcomes in~     randomized control subjects receiving optimal medical management and implanted but inactive~     remedē® systems.~   "
133739|NCT01816763|"~     In light of the importance of pain and widespread interest in patient-centeredness, the~     Department of Veterans Affairs (VA) has been emphasizing and successfully making pain and its~     management a routine feature of the health record and a focus of care. Awareness of pain and~     efforts to improve pain management rest on the VA's '5th Vital Sign' - a policy and practice~     of nursing staff routinely screening for 'pain now' at every health encounter using a 0-10~     Numeric Rating Scale (NRS).~      The team's previous research on VA's '5th Vital Sign' informs the specific design of this~     Effective Screening for Pain (ESP) study as well as the proposed research products.~      Alternatives to the current pain screening approach may improve the sensitivity and~     specificity of screening for chronic pain. These alternatives include the nurse administered~     NRS with a one week look back period and a three item scale (PEG) incorporating intensity and~     emotional and physical interference. The PEG is very similar to the gold standard Brief Pain~     Inventory (BPI) from which it is derived, in its sensitivity, specificity, and sensitivity to~     change in detecting clinically important, functionally impairing pain.~      The investigators plan to evaluate alternatives to the VA's current '5th Vital Sign' for pain~     screening, focusing on simple, feasible measures that can be used cross-sectionally for pain~     screening. In the setting of a primary care clinic, the investigators plan to~     cross-sectionally evaluate three arms - a nurse documented NRS now, a tablet computer-based~     NRS one week, and a tablet computer-based PEG.~   "
133740|NCT01816750|"~     The recently introduced Computed tomography (CT) scanner, Discovery CT750 HD (GE Healthcare,~     Milwaukee), incorporates a battery of innovations aimed at improving diagnostic image~     quality, evaluating perfusion and assessing for scar, in an effort to address the current~     shortcomings of Computed tomographic coronary angiography (CTCA) in patients with significant~     coronary artery disease. The new scanner will use a novel method of scanning (Cardiac~     Gemstone Spectral Imaging - Cardiac GSI) and image reconstruction (Adaptive Statistical~     Iterative Reconstruction- ASIR) as opposed to standard definition 64-slice CT Multi-detector~     row computed tomography(MDCT)and Filtered Back Projection (FBP) used by the conventional CT~     scanners. The Cardiac GSI protocol enables the scanner to acquire images at two different~     x-ray energies almost simultaneously, which can be post-processed to selectively reduce beam~     hardening artefacts and delete materials with specific attenuating properties from the~     images, such as coronary calcium. ASIR offsets the potential increase in radiation dose~     required for Cardiac GSI scanning. This will potentially result in images of higher~     diagnostic quality with an equivalent or perhaps lower dose of radiation compared to present~     technology.~      Furthermore, it is hypothesised that dual-energy acquisition may improve the accuracy of the~     assessment of perfusion.~      Although initial in-vitro results are encouraging, this technology has not been rigorously~     assessed with regards to its feasibility and diagnostic quality, limiting its applicability~     in routine clinical practice. This assessment will require a trial comparing the accuracy of~     Cardiac GSI CTCA with that of Invasive coronary angiography (ICA) for anatomical assessment~     of stenosis, Myocardial Perfusion Imaging with Single Photon Emission Computed Tomography~     (MPI-SPECT) for assessment of perfusion and Cardiac Magnetic Resonance (CMR) for assessment~     of myocardial scar. We have designed a pilot study in this regard which will help us assess~     the feasibility of the scan protocol and provide data to power a larger study to assess the~     diagnostic remit of Cardiac GSI scanning in the assessment of patients with high-risk of~     significant coronary artery disease and myocardial scar.~   "
133741|NCT01816737|"~     Two earlier studies showed measurable fetal hemodynamics changes caused by external pressure~     induced by te abdominal ultrasound transducer. The investigators would like to study the~     response of flow in main fetal vessels to different, mild to moderate pressures induced by~     the abdominal transducer. The pressure induced by the transducer will be measured by a~     digital computed manometer. The flow chances in fetal vessels will be measured by ultrasound~     Doppler. Measurements will be taken on different pregnancy weeks, on one occasion in each~     pregnant woman. Ones without applying transducer pressure (control) and ones after applying~     mild pressure.~   "
133742|NCT01816724|"~     The objective of this study is to validate the spanish (from Spain) version of the Nocturia~     Quality of Life Questionnaire and assess their psychometric properties, using the spanish~     translation provided by the copyright holder.~      Internal consistency (measured by Alpha cronbach coefficient), Reproductibility (measured by~     Intraclass Correlation Coefficient), Convergent Validity (assessed using other already~     validate questionnaires such the International Prostate Symptom Score (IPSS), King's Health~     and Pittsburgh Sleeps Quality Index questionnaires) and Discriminant Validity will be~     evaluated.~   "
133743|NCT01816711|"~     The purpose of this study is to assess whether all frail elderly admitted with hip fracture~     has a vitamin D deficiency, and if s-25(OH)D deficiency increases the risk of hip fracture in~     frail elderly.~      Frail elderly are defined as being 65 years of age or older, and living in nursing homes or~     senior housings.~      The investigators' hypotheses state that:~        1. Frail elderly with hip fractures will have a suboptimal level of vitamin D.~        2. Frail elderly with hip fractures are more likely to have a suboptimal level of vitamin D~          than frail elderly without any hip fractures during the last ten years.~   "
133744|NCT01816698|"~     Prehypertension are associated with an increased risk of atherosclerosis and coronary artery~     disease, and often complicated with the metabolic disorder of glucose and lipid. The~     comprehensive prevention of hypertension is still an important and complex clinical issue.~     Taurine is one of the ingredients of Chinese medicine bezoar ,as an endogenous amino acids is~     central inhibitory neurotransmitter, can regulate the excitability of nerve tissue, regulate~     body temperature, therefore, antipyretic, sedative, analgesic, anti-inflammatory,the role of~     anti-rheumatic, anti-convulsant. In addition, Taurine inhibits platelet aggregation in the~     circulatory system, lower blood lipids, to maintain the body's normal blood pressure and~     prevent atherosclerosis; protective effect on myocardial cells, can be anti-arrhythmic;~     special efficacy to lower blood cholesterol, to treat heart failure. The effect of oral~     Taurine on blood pressure is not consistent, however, many animal study has shown that oral~     administration of Taurine, could reduce 24-hour mean arterial systolic and diastolic blood~     pressure in spontaneous hypertensive rats. Furthermore, Taurine interfere with calcium and~     low affinity binding of the calcium binding sites, decrease the voltage-dependent Ca2+channel~     in vascular smooth muscle relaxation, vasodilation, lower blood pressure.In a prospective,~     double-blind, randomized, and parallel-group study, we will evaluate the effects of Taurine~     granule on blood pressure and metabolic parameters in prehypertensive and mild hypertensive~     patients. This study will help develop future comprehensive prevention and treatment~     strategies for hypertension.~   "
133745|NCT01816685|"~     Patients with a medical condition known as obstructive sleep apnea may be at increased risk~     of delirium following surgery. This study loans autotitrating CPAP machines to~     randomly-selected patients who are at high-risk for obstructive sleep apnea with the goal of~     preventing post-operative delirium.~   "
133746|NCT01816672|"~     The purpose of this study is to determine if AutoloGel platelet rich plasma used on non~     healing diabetic foot ulcers Wagner gd. 1 and 2 is more effective then the usual and~     customary care~   "
133747|NCT01816659|"~     The goal of this clinical research study is to learn more about the possible effects of~     metformin extended release (ER) in patients with colon cancer or adenomas who are about to~     have surgery. The safety of this drug will also be studied.~      Metformin-ER is commonly used to control blood sugar levels in patients with diabetes. It is~     also designed to block a protein in tumor cells that is important in tumor growth and blood~     vessel development. This may cause cell death or reduce the spread of the disease.~   "
133748|NCT01816646|"~     The goal of this clinical research study is to learn how the drug cidofovir given as 1 dose~     directly into the bladder is absorbed by the body. Researchers also want to measure the~     amount of study drug in the body at different time points. The safety and tolerability of~     this drug will also be studied.~      Cidofovir is designed to fight certain viruses by blocking the virus cells from dividing.~   "
133749|NCT01816633|"~     The aim of this trial is to demonstrate the effectiveness of complete wound healing in a~     prospective, open-label, case-matched cohort trial in which diabetic foot ulcers (DFU) will~     be treated using AutoloGel and case-matched against a concurrent cohort of patients receiving~     undefined Usual and Customary Care (UCC) as provided in up to 30 U.S. Wound Registry Research~     Network (USWRRN) centers.~   "
133750|NCT01816620|"~     The purpose of this prospective study is to determine the efficacy and safety of lenalidomide~     plus dexamethasone in patients with newly diagnosed POEMS syndrome.~   "
133753|NCT01816581|"~     Postoperative pain and analgesic treatment still remains a challenge in daily perioperative~     medicine. Skin incisions, intraoperative tissue retraction and -dissection, intravasal~     cannulations and drainages, sternotomy and pericardiotomy are the most important reasons for~     postoperative pain. Poorly controlled pain can contribute directly or indirectly to~     postoperative complications, such as myocardial ischemia, pulmonary dysfunction like~     hypoventilation, pneumonia and atelectasis, a delayed return of gastrointestinal function and~     decreased mobility. In addition, prolonged acute pain also results in chronic pain.~      Opioids are internationally recognized as the golden standard in the treatment of acute~     postoperative pain. On one side, the high potency of opioids in pain relief is clearly~     undisputed, but on the other hand, the administration of opioids is associated with nausea,~     vomiting, sedation and with the development of bowel dysfunction, which encompasses symptoms~     including bloating, abdominal spasm, cramps and constipation. Opioid-induced constipation is~     a frequently reported adverse effect and sometimes requires discontinuation of therapy, which~     results in analgesic under-treatment, severely impairing quality of life. However, there are~     many different regimes for the treatment of postoperative pain using opioids.~     Patient-controlled analgesia (PCA) using morphine is widely used, but requires trained staff~     and expensive equipment. Once patients are able to tolerate oral medications, the oral route~     is preferred postoperatively because it is more convenient, noninvasive and less expensive.~   "
133754|NCT01816568|"~     Laparoscopic techniques have allowed surgeons to perform complicated intrabdominal surgery~     with minimal trauma. In numerous studies, when conventional laparoscopic appendectomy using 3~     ports is compared with open appendectomy, it has advantages of reduced pain, reduced hospital~     stay, and enhanced cosmetic effects. Single incision laparoscopic surgery (SILS) was~     developed with the aim of reducing the invasiveness of conventional laparoscopy. In this~     study the investigators aimed to compare results of SILS appendectomy and three port~     conventional laparoscopic appendectomy prospectively.~   "
133755|NCT01816555|"~     This study is for adult females who have been newly diagnosed with breast cancer that~     includes surgery as part of standard cancer treatment. This is a research study combining~     Vitamin D (an over the counter medication) with the standard of care (or the established and~     approved treatment), surgery. Evidence shows that women who are Vitamin D3 deficient have a~     higher risk of breast cancer and breast cancer recurrence. The purpose of this study is to~     find out the effects of Vitamin D3 during the treatment period for Stage I-II breast cancer.~     Screening tests will be done to determine if subjects are eligible to participate in this~     study. If subjects are eligible and they agree to participate, they will be assigned to one~     of two groups which will receive different amounts of vitamin D. Subjects will be asked to~     keep a medication diary. Subjects may remain on treatment for approximately 56 days.~   "
133756|NCT01816542|"~     The purpose of the study is to determine if any of Mother's Choice' all-natural personal-care~     products cause either irritation or allergic reaction when applied to both normal or~     sensitive skin.~      Each product will be tested on the skin using patch tests.~   "
133757|NCT01816529|"~     The goal of this study will be to determine the potential of Diltiazem Hydrochloride 2% Cream~     to induce sensitization by repeated topical application to the skin of healthy subjects under~     controlled conditions.~   "
133758|NCT01816516|"~     Poor feeding practices during infancy contribute to obesity risk because they interfere with~     infant feeding self-regulation and appropriate growth patterns as infants transition from~     human milk and/or formula-based diets to solid foods. The goal of the project is to provide~     an educational intervention that fosters appropriate maternal responsiveness, feeding styles,~     and feeding practices via infant-centered feeding.~   "
133759|NCT01816503|"~     The purpose of this study is to show the clinical usefulness of fentanyl matrix by measuring~     satisfaction with pain treatment after administering fentanyl matrix in patients whose pain~     was not controlled sufficiently with the previous analgesic use in real practice at the~     investigator's discretion.~   "
133760|NCT01816490|"~     Chronic hepatitis C virus (HCV) is a major cause of morbidity and mortality worldwide with an~     estimated number of 180 million infected patients. Until 2012 the current standard of care~     (SOC) treatment of patients with chronic hepatitis C was a 24 to 72 weeks therapy with~     pegylated interferon- and ribavirin (PR). In 2012, the protease-inhibitors (PI's) telaprevir~     and boceprevir as first directly acting HCV drugs have been approved by the local Swiss~     authority for hepatitis C mono-infected and HCV-HIV-co-infected individuals. However, therapy~     success is strongly limited in null-responders (NR) to previous PR. Treatment of HCV-HIV~     co-infected individuals with the new PI's is accompanied by additional challenges (e.g.~     drug-drug interactions, toxicity, high pill burden). Patients with advanced fibrosis are at~     highest risk for decompensated liver disease and hepatocellular carcinoma (HCC) and prompt~     initiation of treatment is strongly recommended. Recently, data in mono-infected patients~     showed, that in prior non responders a 12 week course of a triple therapy (TT) with~     telaprevir and PR followed by another 24 weeks of PR resulted in an sustained virologic~     response (SVR) of only 29%. In HCV-HIV co-infected non-responders with unfavourable~     preconditions (e.g. HCV-genotype 1, interleukin 28 B non-CC genotype, advanced liver~     fibrosis, high baseline HCV viral load) SVR after TT is even expected to be lower. These~     patients urgently need additional therapeutic options with the goal to eradicate HCV in order~     to prevent further fibrosis progression and to reduce morbidity and mortality. A promising~     substance in the field of drugs targeting the HCV replication is silibinin. Silibinin is the~     main component of silymarin, an extract of the milk thistle Silybum marianum. Intravenous~     silibinin (iSIL) targets multiple steps in the virus life cycle and exhibits anti-oxidant,~     anti-inflammatory, anti-viral and immunomodulatory properties. iSIL inhibits the HCV NS5B~     polymerase activity directly or by interfering with the binding of RNA to this enzyme. In~     addition, iSIL appears to block virus entry, virus transmission and virus secretion.In 2008~     Ferenci et al. for the first time reported the substantial clinical antiviral-effect of~     intravenous silibinin (iSIL) against HCV in PR non-responders. The administration of 20mg/kg~     iSIL in 20 patients led to a highly significant decrease in viral load. We intend to~     investigate the effect and tolerability of iSIL in HIV-HCV co-infected individuals with~     advanced liver fibrosis and previous non- or partial response to SOC. All included~     study-subjects will receive a lead-in therapy with iSIL in a dosage of 20mg/kg/day (expressed~     as silibinin concentration) once a day for 14 days. At the end of the THISTLE study, i.e.~     after the day of completion of the 14-day iSIL administration (day 15), the patients will be~     considered for eligibility to receive standard of care. We assume that the decline in HCV~     viral load would substantially improve the chances of SVR as the reduction of viral load~     should both increase the efficacy of PR and reduce the odds of drug resistance to~     HCV-specific protease inhibitor.~        -  Trial with medicinal product~   "
133761|NCT01816477|"~     Pectus excavatum (PE) is a common chest wall deformity where the sternum is displaced~     posteriorly. In severe cases, surgery is performed to correct the defect. In recent years,~     minimally invasive surgery with the placement of stainless steel support bars has been~     increasingly performed in patients over the age of 17 years. Because of the decreased~     malleability and tremendous pressure required to hold the chest wall in the corrected~     position, post-operative pain control has been a significant problem in this patient~     population. Thoracic epidurals are commonly employed however mean hospitalizations of up to 7~     days have been required before adequate pain control on oral analgesics is obtained and~     patients are suitable for discharge.~      It is hypothesized that using the ON-Q system (I-Flow Corporation, Lake Forest CA) with~     bilateral intercostal catheter infusion would provide adequate post operative pain control~     with a significantly shorter hospital length-of-stay than thoracic epidural. Total use of~     narcotics for 1 week following surgery would also be less with the ON-Q system versus~     epidural.~   "
133762|NCT01816464|"~     The overall aim of this project is to evaluate the immunogenicity of TIV vaccination in~     HIV-uninfected pregnant women compared with HIV-uninfected non-pregnant women in 2013. Safety~     data will also be collected.THe Pregnancy outcomes and the transplacental transfer of~     antibodies will also be assessed.~   "
133763|NCT01816451|"~     The purpose of this study was to verify physiological responses to constant-load (continuous)~     vs. variable-intensity (interval) during 14 weeks of aerobic exercise on active men. The~     hypothesis was that would be differences in physiological variables on distinct modes of~     execution performed on the treadmill over a period of 14 weeks of training.~   "
133764|NCT01816438|"~     The main purpose is to describe clinical practices nowadays prospectively about patients with~     a dysplasia diagnosis or another histological lesions.~      It will be identified colic situation during the initial colonoscopy after dysplasia~     diagnosis or atypical lesion.~      Also the frequency and the type of monitoring conducted about these patients(surgical and~     endoscopic treatments).~      The main criterion evaluation will be the surgical and endoscopic rates during the time.~      The treatments offered such as surgical, endoscopic ones or none of them will be followed.~      Finally, the outcome of these patients: stability, lesion disappearance, surgery or~     development of cancer with frequencies for each of them and relationships with histological~     abnormal colorectal lesion will be measured.~   "
133765|NCT01816425|"~     The cobalt-chromium (CoCr) partial denture has been made for a long period. It respects~     biomechanical principles, providing harmony between mechanical and biological activities. The~     fundamental principles of biomechanics applied in the manufacture of steel structure are:~     retention, reciprocity, attachment and stability. To get the proper planning, we need to~     assess the dental support system, with its qualitative and quantitative values. But~     conventional dentures has a inherent problem which is the metallic elements apparent and in~     some cases the stiffness of the component support elements that generates stress.~      The Thermoplastic partial dentures increase aesthetics in replacement of metal structures in~     oral rehabilitation. So many treatments are being done in everyday practice without a defined~     concept on various aspects of its construction and oral applicability.~      This trial aims to assess the basic parameters of both dentures in: nutrition, speech~     therapy, chewing force, chewing efficiency and quality of life.~      60 years old or older patients who require removable prosthesis. These will be randomly~     selected for the fabrication and installation of removable partial dentures (Gold Standard -~     control group - CoCr partial denture) and thermoplastic partial denture(experimental group).~      Before beginning the work, selected patients will make some preliminary tests such as~     controlling the individual condition, they are:~        -  three questionnaires:~        -  instrument for assessing quality of life related to oral health, GOHAI - General Oral~          Health Assessment Index of Atchinson & Dolan~        -  instrument for assessing the social and economic profile of ABEP (Brazilian Association~          of Research Companies) CCEB 2011;~        -  Instrument for assessing cognitive condition MINI-MENTAL;~        -  Speech evaluation~        -  Nutritional assessment;~        -  Evaluation of masticatory efficiency and~        -  Chewing strength. After preliminary assessments patients will be subjected to treatments~          for manufacture of partial dentures. After the installation (end of the technical~          construction of the dentures) and the adjustments appointment the tests will be repeated~          and in successive control periods of 3 months, 6 months, 12 months, 18 months and 24~          months respectively, when the tests will do again now to see if there was a change in~          the initial condition.~   "
133766|NCT01816412|"~     To demonstrate the safety and efficacy of MD02-LDCB for treatment of stenosis or occlusion of~     the femoral and popliteal arteries in the Japanese population.~   "
133767|NCT01816399|"~     The aim of this study is to determine whether a new vectorcardiogram (VCG) analysis will~     facilitate the detection of significant coronary disease (CAD) in patients with normal rest~     12-leads ECG (NE).~   "
133768|NCT01816386|"~     In the present study, the investigators want to evaluate if press needle acupuncture applied~     prior to surgery may contribute to the anaesthesiologic outcome. Acupuncture might improve~     fast-track anaesthesia in the PACU after general surgery.~   "
133769|NCT01816373|"~     The purpose of this study is to determine whether the non-invasive negative pressure~     treatment with the use of the device Vacuum Bellfor is effective for the pectus excavatum~     treatment~   "
133770|NCT01816360|"~     The purpose of this study is to verify and analyse psychological and physiological effects of~     olfactory aromatherapy and yogatherapy respiratory exercises, together and separately, on the~     quality of life, levels of stress, quality of sleep and intensity and frequence of hot~     flashes in climacteric women.~   "
133771|NCT01816347|"~     The cyclic movement of the heart and the coronary arteries induces relative axial movement~     between the artery and a pre-deployed intra-luminal stent which may cause malpositioning.~     Using a new imaging algorithm to indicate the position of a stent in patients undergoing~     percutaneous coronary intervention (PCI), the investigators will measure the pre-deployment~     relative, intra-luminal stent axial movement in the different coronary arteries to facilitate~     the precise deployment site.~   "
133772|NCT01816334|"~     The purpose of this study is to determine whether anti-inflammatory drugs or glucocorticoids~     are effective in the treatment of acute sciatica~   "
133773|NCT01816321|"~     In combination with the existing literature, previous work indicates that 1) women with poor~     ovarian response fulfilling the Bologna criteria have very low pregnancy rates,~     irrespective of age 2) current treatment protocols demonstrate ongoing pregnancy rates that~     do not exceed 8.5% and 3) corifollitropin alfa followed by hpHMG might increase ongoing~     pregnancy rates in young patients (<40years old) fulfilling the criteria. These findings~     provide a strong rationale for a definitive large RCT. The COMPORT study will provide~     conclusive evidence regarding the superiority or not of this novel protocol with~     corifollitropin alfa followed by hpHMG for the treatment of young poor ovarian responders~     fulfilling the Bologna criteria.~   "
133774|NCT01816308|"~     This study aims to compare the incidence of new-onset cognitive impairments and change in~     existing impairment status between AF patients undergoing either catheter ablation or~     remaining on anti-arrhythmic drugs (AAD) as assessed by Montreal Cognitive Assessment (MoCA).~   "
133775|NCT01816295|"~     The main purpose of this study is to evaluate if testosterone solution can raise testosterone~     hormone levels into the normal range, and also improve levels of sexual arousal, interest and~     drive and/or energy level, in men with low testosterone and decreased sexual arousal,~     interest and drive and/or decreased energy. The study will last about 16 weeks, followed by~     an optional 24 week open label treatment phase to investigate the long term safety of~     testosterone solution.~   "
133776|NCT01816282|"~     A randomized controlled study is performed to address the question of whether the topical~     application of a novel fibrin sealant, Evicel (Johnson & Johnson Wound Management, Ethicon,~     Somerville, NJ) in patient undergoing total knee replacement (TKR) reduce the perioperative~     blood loss and the need for allogenic blood transfusion compared to a control group. We~     hypothesize that fibrin sealant decrease the drop in post-operative hemoglobin level after~     total knee replacement.~   "
133777|NCT01816269|"~     Patients who had received H.pylori eradication treatment will be categorised as eradication~     and reinfection status and whether dental scaling has any influence on these results.~   "
133778|NCT01816256|"~     This study involves screening for portal vein thrombosis and portal hypertension in patients~     with Philadelphia negative myeloproliferative neoplasms (MPNs). These include polycythemia~     vera (PV), essential thrombocythemia (ET), and myelofibrosis.~      Portal vein thrombosis and portal hypertension are serious complications that are often seen~     in myeloproliferative patients. These complications are usually diagnosed when patients~     become symptomatic, and are often already at an advanced stage. They can further progress to~     cause non-reversible damage to the liver, also called cirrhosis of the liver. As a result of~     this, patients often accumulate fluid in the abdomen which is ascites; and can develop~     swelling of veins in the lining of the esophagus known as varices. If untreated, varices have~     the risk of rupturing resulting in life-threatening bleeding. When diagnosed at an advanced~     stage, the treatment is usually supportive therapy and there are no treatments available at~     present which can reverse these conditions.~      This study is looking at screening for these two conditions using Doppler ultrasound and~     upper gastrointestinal endoscopy.~   "
133780|NCT01816230|"~     A Study Evaluating the Safety and Efficacy of Transplantation of a single cord blood unit~     (CBU) of NiCord®, umbilical cord blood-derived Ex Vivo Expanded Stem and Progenitor Cells in~     Patients with Hematological Malignancies.~   "
133781|NCT01816217|"~     Difficult intubation is associated with a worse outcome in intensive care unit (ICU). New~     videolaryngoscope devices are proposed to improve airway management in ICU patients. We aimed~     to compare a new videolaryngoscope called  McGrath Mac Video Laryngoscope vs standard~     Macintosh Laryngoscope in critically ill patients on difficult intubation and/or Cormack 3-4~     rates in a prospective interventional study.The present study was conducted to test the~     hypothesis that the implementation of a quality-improvement process for airway management~     using a new videolaryngoscope would be associated with a decreased incidence of difficult~     intubation and/or Cormack 3-4.~   "
133782|NCT01816204|"~     Therapist assisted, internet-based cognitive behavioral therapy (TAI-CBT) has been shown to~     be effective with patients who have Generalized Anxiety Disorder (GAD) in multiple studies~     from several countries, including: the United Kingdom, Australia, Sweden, and the~     Netherlands. Despite strong evidence of efficacy, TAI-CBT has not been offered in the USA.~     TAI-CBT could provide an effective alternative to face-to-face psychotherapy that would~     expand the availability and convenience of evidence- based treatment anywhere clinical~     availability is limited. The University of Florida (UF) has historically had greater demand~     for psychotherapy than the available supply of psychotherapy hours resulting in waiting lists~     for students needing to receive treatment for anxiety. Anxiety disorders interfere with~     memory and concentration thus impairing academic functioning. Students who must wait for~     treatment for 3-4 weeks are at risk for failing courses or dropping out of school. If TAI-CBT~     proved to be effective with UF students, providing it could increase the number of students~     who would receive effective and timely treatment. This project will create a 6-8 session~     therapist assisted on-line treatment for anxiety disorder. The investigators will offer~     TAI-CBT as an experimental treatment in summer and fall, 2013 comparing outcomes to~     face-to-face individual therapy, group therapy, and wait-list controls. The investigators~     hypothesize that students receiving TAI-CBT will have a reduction in anxiety symptoms~     comparable to face-to-face counseling and greater than wait list controls.~   "
133783|NCT01816191|"~     The study is a single-center, open-label, safety and pharmacokinetic study in12 adult~     subjects with Anal Fissures. Subjects will be screened to determine eligibility within 7 days~     of treatment. There will be three parts to the study and all subjects will participate in~     each part.~   "
133784|NCT01816178|"~     It was proposed that in order to teach these children to use a Voice Output Communication Aid~     (VOCA), it should be introduced through a play-based situation using parents as the primary~     interventionist.~   "
133785|NCT01816165|"~     Insulin resistance (IR) is an important contributor to increased cardiovascular disease risk~     in type 1 diabetes (T1D). Non-esterified fatty acid elevation is a significant contributor to~     IR in T1D and may be a target of intervention. The hypothesis of the study is that isolated~     fatty acid lowering with acipimox will improve insulin action and blood vessel function and~     have the benefit of reducing mitochondrial oxidant generation and improving mitochondrial~     function in T1D. Targeting IR through fatty acid lowering is a novel approach to T1D~     treatment that may significantly improve current management of TID and of cardiovascular~     disease (CVD) risk in this high risk population.~   "
133786|NCT01816152|"~     Tailored light treatment will increase sleep efficiency, reduce depression and reduce~     agitation scores in those with Alzheimer's disease and related dementia~   "
133787|NCT01816139|"~     The primary objective of this study is to compare the efficacy of WC3011 with placebo vaginal~     gel in postmenopausal women for the relief of vaginal dryness caused by vaginal atrophy as~     measured by self-assessment, vaginal pH and vaginal smear.~   "
133788|NCT01816126|"~     Colonoscopy can be performed by a one-operator technique with endoscopist personally~     advancing and withdrawing the scope or by a two-operators technique, with the GI-assistant~     doing the physical insertion and withdrawal of the scope directed by the endoscopist.~     Uncontrolled data report that 1 operator technique is associated with a higher adenoma~     detection rate, although it is also characterized by a lowwer cecal intubation rate and~     longer intubation time. The aim of present randomized controlled study was to assess whether~     one technique is better than the other one in terms of colonoscopy quality performances.~   "
133789|NCT01816113|"~     This is an open label phase Ia study, to assess the safety of two novel malaria vaccines,~     ChAd63 PvDBP, with or without MVA PvDBP. Heterologous prime-boost with ChAd63-MVA is, to our~     knowledge, one of the most potent T cell-inducing subunit vaccine regimens which can~     importantly also induce antibodies. Previous clinical trials using this regimen expressing~     ME-TRAP, AMA1 & MSP1, have shown that administering ChAd63 as a prime followed 8 weeks later~     by MVA as a boost is a very immunogenic schedule (32-34). For this reason, and to provide~     comparability with previous ChAd63-MVA trials, we propose to use a similar administration~     schedule.~   "
133790|NCT01816100|"~     This study is a unique blend of new technologies never used in combination with individuals~     diagnosed with Multiple Sclerosis (MS). The results of this research will define changes in~     brain activity, functional brain activation and diffusion in the brain following 6 months of~     structured weight resistance and balance training. Positive changes would indicate that the~     therapy has ignited brain plasticity and may drive the brain to repair itself. These changes~     to the brain may affect recovery as a result of neuroplasticity, neuroprotection, and slowing~     of neural degeneration. No other trials have been published evaluating brain plasticity~     utilizing diffusion tensor imaging (DTI) and magnetoencephalography (MEG) in subjects with MS~     undergoing physical training. DTI has demonstrated the ability to find changes (plasticity)~     that occur in the brain and using the MEG findings to focus the DTI analysis will optimize~     the capacity to detect changes secondary to therapy. This quantification will give a better~     understanding of the repair that goes on in the brain, and may potentially revolutionize the~     field of the central nervous system (CNS) rehabilitation. One of the most innovative aspects~     of this study is the full integration of clinical neurobehavioral metrics and functional~     imaging data in conjunction with a proven MS therapy along with quality of life indicators.~     This approach will allow new links to be illuminated as the trajectories of functional and~     structural brain changes (neuroplasticity) are meshed with clinical improvement indices~     collected visit-by-visit. This study will also compare disease modifying treatments (DMTs)~     and their effect(s) on indices of brain plasticity and cognitive and behavioral assessments.~   "
133791|NCT01816087|"~     The AGE (Active Geriatric Evaluation) aims to develop a brief assessment tool adapted to the~     primary care setting.~   "
133792|NCT01816074|"~     We hypothesize that successfully treating maternal Attention Deficit Hyperactivity Disorder~     (ADHD) will have a beneficial effect that extends to the child. We believe that~     multi-component interventions combining maternal stimulant medication, Lisdexamfetamine~     (LDX), and Behavioral Parent Training (BPT) will improve parenting, maternal, and child~     outcomes. In terms of improved parenting, we hypothesize that some mothers may respond well~     to LDX or BPT alone and therefore may not require multi-modal treatment, whereas others may~     benefit most from multi-modal treatment~   "
133793|NCT01816061|"~     Interventional, controlled clinical trial with two arms, 110 Veterans with TBI and PTSD~   "
133794|NCT01816048|"~     The purpose of this study is to assess whether NaF PET/CT scans can be used to evaluate~     treatment response in bone metastases in subjects with prostate cancer treated with the~     investigational drug, TAK-700.~   "
133795|NCT01816035|"~     This phase I trial studies the side effects and best way of giving trastuzumab emtansine in~     treating patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer~     that has spread to other parts of the body or nearby tissue and cannot be removed by surgery.~     Biological therapies, such as trastuzumab emtansine, may stimulate the immune system in~     different ways and stop cancer cells from growing.~   "
133796|NCT01816022|"~     This is a clinical study to evaluate the effect of CMPN (Chronic myeloproliferative neoplasm)~     to the bone.~      The hypothesis is that patients with CMPN have a higher fracture-rate compared to the~     background population. We expect to find a lower BMD using conventional DXA scan (dual energy~     x-ray absorptiometry), and a change in other parameters using HR-pQCT (high-resolution~     peripheral quantitative computerized tomography).Biochemical bone markers is measured to~     support the hypothesis.~   "
133797|NCT01816009|"~     The study is a prospective, open randomized, non-inferiority trial with two parallel groups,~     comparing 6 weeks versus 12 weeks of antibiotic treatment following surgery procedure~     (debridement and retention, 1-stage or 2 stage exchange).~      The duration of the treatment antibiotic of prosthetic joint infections is only based on~     experts' opinion ; this one varies from 6 weeks to several months according to the customs of~     the influencer.~      The principal aim of this study is to explore the efficacy and safety of 6 weeks versus 12~     weeks antibiotic therapy duration, both associated with surgical procedure (debridement and~     retention of implant, one-stage or two stages exchange), in PJI treatment.~      The study concerns 410 men or women of more than 18 years include in 34 centres in France.~      The duration of the study is of 4 years.~   "
133798|NCT01815996|"~     The investigators are developing a test that is expected to measure the amount of radiation a~     patient has been exposed to after a nuclear bomb. The investigator will do this by measuring~     the DNA in the patients blood from cells killed by the radiation.~      Many diseases and medical conditions can put DNA in the blood. The investigator needs to know~     how much DNA in order to better interpret our radiation detection test. Therefore, the~     investigator is collecting blood from several patients with different diseases or medical~     conditions and also healthy volunteers to measure their DNA content.~      Patients that will be included in this study are pregnant women, patients who have suffered a~     pulmonary embolism within the past 48 hours, patients who have suffered from myocardial~     infarction in the past 48 hours, patients with autoimmune diseases and health patients.~   "
133799|NCT01815983|"~     This study is designed to evaluate the impact of a video recording review on the acquisition~     of a new technical skill (laryngoscopy and tracheal intubation).~   "
133800|NCT01815970|"~     Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death world-wide.~     Dyspnea (i.e., sensations of breathlessness) is the hallmark symptom of patients with this~     disease. Pulmonary rehabilitation programs that incorporate exercise training remain the most~     effective non-pharmacological method of reducing dyspnea in COPD, however it is not~     understood how exercise training relieves dyspnea. Accordingly, the purpose of this study is~     to determine if pulmonary rehabilitation can reduce the disparity between the drive to~     breathe and the breathing response in patients with COPD and to determine if this reduction~     is associated with improvements in dyspnea during exercise.~      The investigators hypothesise pulmonary rehabilitation will reduce dyspnea at a standardized~     work rate and this reduction will be directly related to an improvement in the breathing~     response.~   "
133801|NCT01815957|"~     This study is being done to determine if Ranolazine treatment improves coronary~     microcirculation function among patients with coronary microcirculation dysfunction. We are~     also looking to learn if symptomatic improvement of chest pain during treatment with~     Ranalozine is related to improved coronary microcirculation function.~   "
133802|NCT01815944|"~     Regional anesthesia employs the use of local anesthetics (LA) to block specific nerves to~     enable pain free surgery to be performed, or for intra and post operative pain relief.~     Dilution of local anesthetics with normal saline (NS) is a common practice to enable larger~     volumes of LA to be given, for example, in instances where multiple nerve blocks are needed~     to be performed for optimal pain relief while avoiding toxic doses.~      A high sodium concentration is known to antagonize the analgesic effect of local anesthetics.~     5% dextrose (D5W) on the other hand is painless on injection and does not cause any long-term~     effects in animals or humans when injected around neurological tissue. In the literature,~     only one study using dextrose 5% as diluent to produce 0.5% ropivacaine for axillary brachial~     plexus block showed a statistically significant reduction in the onset time for sensory~     blockade when compared with dilution with NS.~      In this study, 0.5% ropivacaine diluted with D5W or NS is used for ultrasound guided~     supraclavicular brachial plexus block, and the time for complete sensory and motor blockade~     was compared. 0.5% ropivacaine is easily diluted and is a common concentration used at our~     centre for nerve blocks. The aim of this study is to assess if 0.5% ropivacaine diluted with~     D5W results in a shorter onset time for sensory block which may change the current practice~     of dilution with NS~   "
133803|NCT01815931|"~     In this study, we aim to identify risk factors for hemolysis in blood samples drawn in the~     ED.~   "
133847|NCT01815359|"~     This is the first randomized trial comparing Early post-operative intraperitoneal~     chemotherapy (EPIC) and hyperthermic intraperitoneal chemotherapy (HIPEC) for appendiceal and~     colorectal cancer. The purpose of this study is to find out what effects, good and/or bad,~     EPIC and HIPEC after cytoreductive surgery have on the patient and the appendiceal, rectal or~     colon cancer.~   "
133804|NCT01815918|"~     One postoperative complication following unilateral or bilateral total knee arthroplasty is~     thrombosis (blood clot formation). In this prospective, double-blinded randomized controlled~     clinical trial, researchers are investigating the effect of steroids on biochemical markers~     of thrombosis. Furthermore, elevated cellular markers of thrombosis (specifically IL-6) have~     been linked to postoperative depression following total knee arthroplasty surgery. Hence the~     investigators are also checking if use of hydrocortisone, a steroid, may help reduce the~     incidence of postoperative depression.~      Other studies have shown that surgery causes some reaction in the body that is consistent~     with inflammation. When the inflammation is extensive, it may affect different parts of the~     body. It may also lead to clotting disorders and result in blood clots. In a previous study~     by this principal investigator (see reference 22, Use of low-dose steroids in decreasing~     cytokine release during bilateral total knee arthroplasty), hydrocortisone was administered~     over 24 hours following surgery to patients who underwent bilateral total knee arthroplasty.~     The investigator found lower levels of cellular markers consistent with inflammation~     (specifically the protein, IL-6). Steroid use also showed additional benefits, such as~     decreased pain and better range of motion at the knee.~      In this study, investigators recruit patients undergoing total knee arthroplasty surgery.~     Patients are randomized to receive three 100 mg doses of hydrocortisone or three doses of a~     saline placebo. In addition to analyzing patients' blood samples for hydrocortisone's effect~     on clotting factors (i.e. IL-6), investigators record patients' pain scores and patients'~     oral analgesic use. To assess patients' well-being, patients are contacted one month and 3~     months following their surgeries and administered the Patient Health Questionnaire (see~     reference 23, The PHQ-9: validity of a brief depression severity measure.) arthroplasty.~   "
133805|NCT01815905|"~     Provides mobile programs for occupational and speech therapy to patients with stroke.~   "
133806|NCT01815892|"~     Patients often begin dialysis taking diuretics (stimulate the kidney to excrete salt and~     water). Once on dialysis, these drugs are often continued. Whether these drugs are still~     needed, or even effective is often unclear.This study,by evaluating the composition of the~     patients' urine when off the drug, will predict which patients should benefit from the drug.~     By comparing their 24 hour volume both off and on the drug, the impact of the drug will be~     established. The results will allow the prediction of which patients, in the future, should~     take the drug. The hypothesis is: Among dialysis recipients, evaluation of the random urine~     sodium concentration will help predict the likelihood of a positive response to Furosemide,~     as manifested by an increased urine volume and sodium excretion.~   "
133807|NCT01815879|"~     Investigator initiated multi-institutional retrospective review of clinical and radiographic~     outcomes after 90Y resin microsphere radioembolization for metastatic colorectal liver~     metastases in the USA. The target is for at least 1,000 evaluable patients with 12+ weeks~     follow up.~   "
133808|NCT01815866|"~     Non-tuberculous mycobacteria (NTM) are opportunistic pathogens normally found in soil and~     water that are being cultured from Cystic Fibrosis (CF) airways at an increasing frequency.~     They have been demonstrated to cause clinically significant lung disease in some cases and~     the transmission of NTM, from person to person has been proposed. There are currently no~     standardized guidelines for isolation of those colonized or infected with NTM.~      The investigators will measure particle droplet size from patients with CF who have positive~     sputum cultures for NTM with the hypothesis that they will be in a range that can spread~     infection.~   "
133809|NCT01815853|"~     Background: It has been shown that the patitents with gastric cancer could benefits from~     peri-operative chemoradiotherapy, but whether the pre-operative chemoradiotherapy can improve~     patitents' outcome is still unclear.~      Patients and methods: In this study , patients with histologically confirmed gastric cancer~     whose pre-operative staging are cT4 any N,MO, aged from 18 to 70 years and with Eastern~     Cooperative Oncology Group performance status ≤2 and adequate organ function, are randomized~     1:1 to receive pre-operative chemoradiotherapy with DT45Gy/25f plus two cycles of~     XELOX(Xeloda 1000mg/m2, BID, DI-D14; Oxaliplatin 130mg/m2 on day 1;,21-days per cycle) or~     chemotherapy alone then following by surgical resection and adjuvant chemotherapy with XELOX~     at the same dose up to 4 cycles. The primary end point is overall survival (OS), and~     secondary end point is disease free survival(DFS) and safety. Final study analysis will be~     conducted in the end of the 5th year after the last patient's enrollment.~   "
133810|NCT01815840|"~     This randomized, double-blind, regimen-controlled, phase II, multicenter study will assess~     the efficacy and safety of two different vismodegib regimens in participants with multiple~     basal cell carcinoma. Participants will receive vismodegib 150 mg orally once daily either in~     an intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo (Arm A) or as 24~     weeks induction followed by an intermittent schedule of 8 weeks placebo followed by 8 weeks~     vismodegib (Arm B). Anticipated time on study treatment is 72 weeks.~   "
133811|NCT01815827|"~     This open-label, parallel group study will evaluate the safety, tolerability,~     pharmacokinetics and pharmacodynamics of single doses of inclacumab in Japanese healthy~     volunteers compared to Caucasian healthy volunteers. Subjects will receive a single~     intravenous dose of inclacumab. Follow-up will be for up to 197 days.~   "
133812|NCT01815814|"~     The investigators hypothesize that children with spastic cerebral palsy will show greater~     improvements in gross motor function, associated developmental skills and growth after the 3~     months of myofascial structural integration treatment, a form of deep massage, than they~     showed after a 3- or 6-month pre-treatment waiting period.~      The investigators further hypothesize that children with spastic CP will maintain their gains~     in gross motor function for ≥ 3 months after completion of MSI treatment.~   "
133813|NCT01815801|"~     The purpose of this study is to determine whether mechanical ventilation influences the~     incidence of pneumothorax after subclavian venous catheterization.~   "
133814|NCT01815788|"~     A personal sound amplifying device (PASP) like Teo First is a wearable electronic product~     that is not intended to compensate for impaired hearing, but rather is intended for~     non-hearing impaired consumers to amplify sounds in the environment for a number of reasons,~     such as for recreational activities. Nevertheless, a lot of mild and moderate impaired~     hearing people don't want to buy and wear all day a real hearing aid.~      The goal of our study is to evaluate the benefit of such a device for mild and moderate~     presbycusis patient 60 years of age and older, with no previous hearing aid.~   "
133815|NCT01815775|"~     The idea is to assess the predictive value of flow magnetic resonance imaging (flow MRI) for~     patient suffering normal pressure hydrocephalus (NPH) planned for surgery. By now, the~     depletive lumbar puncture is the best test assessing the efficacy of a forthcoming surgery.~     The idea is to demonstrate that flow MRI can be as effective as lumbar puncture in term of~     predictive value of surgery response.~      In that way, cerebrospinal fluid (CSF) dynamics are evaluated by a single non invasive~     examination. CSF flow is measured at the Sylvius' aqueduct, cervical, arachnoid space and 4th~     ventricle levels.~   "
133816|NCT01815762|"~     Patients will be selected from the Dialisys Centers in Iasi, Romania. Patients will be~     randomized 1:1 to have a dry-weight assessment based on clinical (control) or lung US and~     bioimpedance (active) guided protocol. In the control group post-dialysis dry weight will be~     adjusted based on clinical criteria only (blood pressure, presence of edema, intradialytic~     hypotension, cramps etc.) and in the active group the target weight will be prescribed using~     lung US and bioimpedance evaluation.~      In patients randomized to the active arm of the study, the US B-line score (BLS) will be~     measured before dialysis and these measurements will be used to titrate ultrafiltration~     prescription. In patients presenting moderate to severe lung congestion (≥15 BLS~     pre-dialysis) LUS measurements will be repeated once a week until the treatment goal was~     achieved (<15 BLS pre-dialysis) and once a month thereafter. The same (monthly) monitoring~     frequency will be adopted also in patients without pulmonary congestion at pre-dialysis~     baseline (<15 BLS). Furthermore, the use of the technique is allowed whenever its application~     is deemed useful to assume clinical decisions by attending physicians. Patients in the active~     arm of the study without evidence of lung congestion at baseline who developed pulmonary~     congestion (≥ 15 BLS) during the trial will received the same treatment contemplated for~     those with lung congestion at baseline during the trial. The treatment goal will be pursued~     by ultrafiltration intensification realized within the same HD schedule (3 sessions x 4~     hours/week) or, if not tolerated, by extra-dialyses, according to individual tolerance and~     feasibility. In case of clinical hypovolemia (persistent cramps, hypotension etc) additional~     dry-weight adjustments will be performed according to the bioimpedance measurement, provided~     that the patients are below 15 BLS. This addition will be necessary in order to be able to~     increase the dry-weight in patients with a persistent BLS < 15 and avoid under perfusion.~      Patients in the control arm of the study will be followed up and managed strictly with~     standard criteria according to current recommendations (implying optimization of fluids~     volume control on the basis of clinical criteria and the use of carvedilol, ACE~     inhibitors/sartans whenever deemed necessary); the use of lung US / bioimpedanc assistance~     will not be messured in these patients.~      The main exclusion criteria will be the presence of severe cardiac failure (NYHA class~     III-IV), past myocardial infarction, stable or unstable angina and acute coronary syndrome.~     Due to bioimpedance assessment limitation patients with metallic joint prostheses, cardiac~     stent or pacemakers, decompensated cirrhosis, pregnancy and limb amputations will be~     excluded, as BIS cannot be accurately performed in such cases. Due to lung US measurement~     limitation we will exclude patients with known persistent pleurisy, pulmonary fibrosis or~     pneumectomy. Other exclusion criteria will be malignancy, active infections, temporary or~     permanent catheter as a vascular access, mental incompetence and unwillingness to participate~     in the study.~   "
133817|NCT01815749|"~     This phase I trial studies the side effects and best dose of genetically modified T-cells~     following peripheral blood stem cell transplant in treating patients with recurrent or~     high-risk non-Hodgkin lymphoma. Giving chemotherapy before a stem cell transplant helps stop~     the growth of cancer cells. When the healthy stem cells from a donor are infused into the~     patient they may help the patient's bone marrow make stem cells, red blood cells, white blood~     cells, and platelets. Sometimes the transplanted cells from a donor can make an immune~     response against the body's normal cells. Removing the T cells from the donor cells before~     transplant may stop this from happening. Giving an infusion of the donor's T cells (donor~     lymphocyte infusion) later may help the patient's immune system see any remaining cancer~     cells as not belonging in the patient's body and destroy them (called graft-versus-tumor~     effect)~   "
133818|NCT01815736|"~     This study is to evaluate the non-inferiority of switching to a tenofovir alafenamide~     (TAF)-containing fixed dose combination (FDC) relative to maintaining tenofovir disoproxil~     fumarate (TDF)-containing combination regimens in virologically suppressed HIV-infected~     participants as determined by having HIV-1 RNA < 50 copies/mL at Week 48.~   "
133819|NCT01815723|"~     This multicenter, randomised, double-dummy, Fumaderm® and placebo-controlled, parallel-group~     study will compare the efficacy and safety of 500 mg of FP187 (250 mg twice daily) compared~     to 720 mg Fumaderm® (240 mg three times daily) over 20 weeks of treatment. After an initial~     wash-out non-drug treatment phase of 1 to 6 weeks, all patients will receive allocated Study~     treatment up-titrated to the relevant dose level (i.e., 500 mg daily FP187, 720 mg daily~     Fumaderm®, or placebo). The up-titration to full dose will last 4 weeks for FP187 and 9 weeks~     for Fumaderm®. After 20 weeks of treatment, all patients will be asked to enter a separate~     open label treatment protocol expected to continue for up to 5 years.~   "
133820|NCT01815710|"~     An Ontario-wide study to identify best strategies to promote uptake of high quality, expert~     developed Clinical Pathways (CPs) within Emergency Departments.~      The investigators will work with 16 Community EDs across Ontario to i) tailor an~     implementation strategy that works for each ED, ii) assist with the implementation of one~     pediatric emergency CP (Asthma or Gastroenteritis) at each site, and iii) evaluate the impact~     on health professionals, patient outcomes and economic costs. The investigators will conduct~     a 3.5 - year mixed methods health services research project with four study objectives: 1) to~     design a theory-based and knowledge user-informed intervention strategy to successfully~     implement two provincial pediatric emergency clinical pathways into practice in community~     Emergency Departments (EDs); 2) to evaluate the effectiveness of this implementation~     strategy; 3) to conduct a process evaluation to assess the implementation strategy; and 4) to~     conduct an economic analysis to evaluate implementation costs and benefits.~   "
133821|NCT01815697|"~     The purpose of this study is to access the effects of Enhanced External Counterpulsation~     treatment on lower urinary tract symptoms in patients with benign prostatic hyperplasia.~   "
133822|NCT01815684|"~     The purpose of this study is to explore the safety (including the effect on cardiac~     intervals), tolerability, the effects on the Central Nervous System (CNS), as well as the CNS~     side effect profile of single ascending doses of ASP3652 in healthy, Caucasian male and~     female subjects.~   "
133823|NCT01815671|"~     A tortuous sigmoid colon makes colonoscopy difficult. The purpose of this study was to~     systematically evaluate the diagnostic utility and incidence of adverse events in women using~     standard horizontal compared to lateral tilt down positioning for colonoscopy.~   "
133824|NCT01815658|"~     The aim of this study is to present a novel Intramedullary Nail (IMN) made of CFR - PEED~     composite, that is biomechanically tailored to closely match cortical bone. This IMN should~     promote fracture healing and prevent stress shielding osteopenia.~      Case records of patients with humurus shaft fracture will be retrospectively reviewed to~     determine whether the implant promotes bone healing.~   "
133825|NCT01815645|"~     Crack addiction has become a severe health problem in Brazil. Today, crack addiction is the~     primary cause for inpatient treatment for all illicit substances. When compared to cocaine,~     crack users develop much faster diagnoses for crack dependence, shows a more compulsive~     pattern of use, has higher probability of living or have lived in the streets, and of~     engaging in illegal activities. Consequently to this, mortality of crack addicts is 7 times~     higher than for the rest of the population.~      Despite all efforts being made for the development of effective pharmacological treatments~     for stimulant addiction (crack included), up to today, there is no robust evidence of~     efficacy of any pharmacological treatment. For that reason, the use of evidence based~     psychosocial interventions is so important for treating this population.~      Although today open treatment facilities in Brazil are more and more starting to use~     evidence-based interventions such as motivational interviewing, cognitive behavior therapy,~     relapse prevention and coping skills, such treatments present very modest results when~     treating crack addiction. The biggest difficulties encountered when treating this population~     are maintaining patients in treatment, reducing crack use and achieving continued abstinence.~      A psychosocial treatment based in behavioral principals' named Contingency Management (CM) is~     widely applied in the USA. Recent meta-analyses and review studies present robust evidence~     that, when applied alone or in adjunction with other psychosocial and pharmacological~     treatment, CM is the most effective treatment for what regards, treatment retention, reducing~     drug use and promoting continued abstinence.~      The purpose of this study is to evaluate if Contingence Management (CM) can be affective in~     the treatment of crack addiction in Brazil. To accomplish this, 60 individuals (male and~     female from 18 to 65 years of age) seeking open treatment for crack addiction will be~     randomized to 2 treatment conditions (Standard treatment (ST) or ST+CM. Both treatments will~     last 12 weeks with 3 and 6-month follow-up. In both groups patients will be encourage to~     leave urine samples 3 times week.~      Hypotheses: Patients receiving ST+CM will stay longer in treatment, have more negative tests~     for cocaine/crack, and achieve longer periods of cocaine/crack abstinence when compared to~     patients receiving ST alone.~   "
133826|NCT01815632|"~     Multiple sclerosis - MS - affects 1.3m people worldwide, costing the European Union economy~     €9 billion/year, through both direct and indirect consequences of progressive disability.~     Despite the usual relapsing-remitting presentation, over 80% of patients develop progressive~     disability; 40% require a wheelchair within 10 years of diagnosis. At present, there are no~     treatments that reverse, halt or even slow progressive disability in MS.~      The investigators recently completed one of the first feasibility/safety trials in the world~     of reparative bone marrow cell therapy in 6 patients with longstanding MS~     (www.nature.com/clpt/journal/v87/n6/full/clpt201044a.html). Safety was confirmed, and~     intensive repeated tests on the patients measuring nerve conduction in various pathways in~     the brain and in the spinal cord showed statistically significant improvements at 12 months~     in every patient. While highly preliminary and involving only a very small number of~     patients, these results at least raise the possibility of a significant (though very partial)~     underlying repair effect within the damaged nervous system.~      The investigators believe this urgently requires further testing - both to accelerate benefit~     for patients, and to begin improving therapeutic efficacy. The investigators therefore~     propose a programme of translational and clinical stem cell research, aiming (1) to continue~     translation with a phase two controlled trial of bone marrow cells in patients with~     longstanding MS; and (2) to explore in parallel the potential mechanisms of action, by~     studying bone marrow cells from treated patients and control subjects, aiming to establish~     which of the various relevant bone marrow subpopulations contribute to efficacy, and which~     particular reparative mechanism(s) are important. The investigators hope these studies will~     not only confirm the therapeutic benefit of this approach, but also provide the basis for~     improving the magnitude and impact of this novel and exciting treatment modality.~   "
133827|NCT01815619|"~     This study will test two different methods for processing biopsy specimens taken from the~     bile duct. Patient;s who are asked to participate int his study have a growth (mass) in the~     bile duct that needs a biopsy so a diagnosis can be made. Standard of care includes~     performing 5-7 biopsies in the bile duct and sending the tissue to the lab for testing to~     make a diagnosis. Using this method the investigators can establish a diagnosis only about~     50% of the time. The investigators believe that if a pathologist is available in the~     endoscopy suite during the procedure, the investigators can improve the test results. The~     purpose of this study is to compare the two methods for processing biopsies obtained from the~     bile duct.~   "
133828|NCT01815606|"~     This study will test two different needles for performing a biopsy of the pancreas during~     endoscopic ultrasound (EUS) procedures. Patients who are asked to participate in this study~     have a growth in the pancreas measuring greater than 35mm that needs a biopsy so that a~     diagnosis can be made. The biopsy can be performed using either a 19 or 25-Gauge needle. The~     purpose of this study is to compare which of the two needles is better for performing~     biopsies of the pancreas on masses that are greater than 35mm.~   "
133829|NCT01815593|"~     The purpose of this study is to investigate the efficacy of Enhanced External~     Counterpulsation (EECP) in patients with erectile dysfunction~   "
133830|NCT01815580|"~     This study will recruit men and transgender women with acute or recent HIV infection. It wil~     look at how HIV medicines (ART) when given very early after HIV infection affect the amount~     of HIV in the blood, semen and rectal secretions. In addition, Investigators will be using~     modeling studies to look at whether or not this kind of HIV treatment can decrease the risk~     that a man will infect a person he has sex with and to find out how failure to take~     medications will impact spreading the virus to other people.~      In this study, one group will be randomized (like a coin toss) to start ART immediately (just~     at the time of the enrollment visit) and the other group will wait until week 24 of the study~     to start ART. Both groups will be followed for a total of 48 weeks and will continue to~     receive ART from local sources after the study is over.~   "
133831|NCT01815567|"~     The purpose of this study is to study the impact of blood pressure on cognitive performance.~   "
133832|NCT01815554|"~     This is an observational longitudinal study designed to identify and describe long term~     outcomes for patients with high tetraplegia who use a Diaphragmatic Pacing System (DPS). As~     this is not a randomized or experimental study, no specific hypotheses are proposed. The data~     collected will enable us to answer the following research questions:~        1. What are the patterns of long-term DPS use (hours per day using DPS, changes in DPS~          stimulus parameters, abandonment of DPS and related reasons).~        2. What mechanical problems have DPS users encountered (system failure, repairs needed)?~        3. What are the frequency of and reasons for rehospitalization following DPS implant?~        4. What levels of care are needed at home to manage the DPS?~        5. How do DPS users feel about the system (satisfaction, comfort, vocalization, taste,~          swallowing)?~   "
133833|NCT01815541|"~     This is a biomedical research, prospective, mono centric, tolerance study Of the~     administration of subcutaneous teicoplanin in the treatment of osteoarticular infections.~   "
133834|NCT01815528|"~     Single -arm, multicenter phase-II trial for catumaxomab and chemotherapy in patients with~     recurrent ovarian cancer to investigate the feasibility and clinical activity of initial~     intraperitoneal catumaxomab followed by chemotherapy regimes.~   "
133835|NCT01815515|"~     This research is being done to see if an investigational radioactive drug called 18F-DCFBC~     can help us find cancer that has spread (metastatic disease) from its original site in people~     who have cancer in their prostate to other parts of their body.~   "
133836|NCT01815502|"~     The study will investigate the cardiovascular effects of sildenafil on patients with Fontan~     circulation. Recent studies suggest that sildenafil may improve exercise in patients with~     Fontan circulation. However, why this occurs is not known. The study will used specialized~     catheters to measure pressure and volume. The measure of pressure and volume leads to more~     detailed analysis of heart function. Patients will receive either sugar pill or sildenafil~     prior to catheterization. It is believed that sildenafil will improve relaxation and~     contraction of the heart.~   "
133837|NCT01815489|"~     Necrotizing pancreatitis is a severe form of inflammation of the pancreas with subsequent~     destruction of the pancreas (necrosis). Often, this condition manifests in patients as an~     overwhelming systemic inflammatory response and multisystem organ failure. Many times the~     pancreas can become superinfected with bacteria and other organisms as a result of this~     process. Clinicians may decide to sample fluid from the pancreas or pancreatic tissue to~     determine the presence of infection. This can be done through surgery with a concurrent~     debridement and drainage of the pancreas or by a radiologist using an ultrasound or CT guided~     method to sample the pancreatic fluid. These samples are then sent for culture in the~     microbiology laboratory. Culture results often reveal 1-2 types of infecting bacteria that~     originate from the gastrointestinal tract. The investigators hypothesize that in actuality,~     many different kinds of bacteria may infect the pancreas. This project uses molecular DNA~     techniques to help identify bacteria present in the pancreas of patients with severe~     necrotizing pancreatitis.~   "
133838|NCT01815476|"~     Participants undergoing radiation after breast conserving surgery for an early breast cancer~     (either Ductal Carcinoma In Situ (DCIS), or Early Stage Invasive breast cancer), and are at~     increased risk of developing a skin reaction because of their large breast size.~      After breast conserving surgery (also known as a 'lumpectomy'), women with either DCIS or~     early stage invasive breast cancer receive radiation to the breast to decrease the risk of~     cancer recurrence. Breast radiation is usually done with women lying on their back~     (supine). Some women develop temporary breakdown of the skin (moist desquamation). This~     skin reaction can be painful and has been linked to long term side effects such as chronic~     pain and decreased quality of life.~      This study is being done because women with large breasts have higher rates of skin breakdown~     (called 'moist desquamation') and breast pain during and shortly after radiation therapy is~     complete. It is unclear if such skin reactions and pain would be improved by alternating~     treatment position - namely lying on your belly (prone) during their radiation treatment.~   "
134367|NCT01808534|"~     This phase II trial studies how well palifosfamide works in treating patients with recurrent~     germ cell tumors. Drugs used in chemotherapy, such as palifosfamide, work in different ways~     to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing~   "
133839|NCT01815463|"~     Hypothesis:The Adnab-9 antigen is a predictive biomarker in individuals at risk of developing~     colorectal neoplasia.~      Study aim is to evaluate the potential of the Adnab-9 monoclonal antibody (MAb) as a marker~     of cancer risk in a population at increased risk for colorectal cancer (CRC). This marker~     would be compared to other current and emerging diagnostic methods. 2,800 Veterans would be~     recruited into the study. In phase 1, candidates would be defined as having increased CRC~     risk by a short questionnaire. Stool samples would be obtained and a semi-quantitative~     Adnab-9 antigen assay (ELISA) would be determined. Patients with differing high and low~     estimations of fecal Adnab-9 would undergo colonoscopy at which time other samples of~     effluent and colonic mucosa would be taken, and a detailed lifestyle and nutritional~     questionnaire would be completed. The characteristics of the Adnab-9 fecal test as a~     diagnostic test would be critically determined using the outcome of the colonoscopic and~     other test results. The patients will be contacted through the mail and by word of mouth.~     Informed consent will be obtained before the samples are obtained. The participants are~     clinically defined as high-risk and therefore screening colonoscopy would be likely performed~     in any event. A number of assays for Adnab-9 are feasible including slot-blot, Western blot,~     and ELISA. Other stool studies include conventional fecal occult blood tests (FOBT or FIT)~     that will be performed in tandem. The investigators therefore began this method of collection~     and obtained consent from over 2000 patients with a similar overall compliance rate with FOBT~     screening procedures to that reported previously of approximately 50%. Currently the study is~     no longer enrolling patients at the Detroit VA and is now finalizing data entry. Another 450~     patients to be recruited at the Philadelphia VAMC.~   "
133840|NCT01815450|"~     The purpose of this study is to compare the safety and efficacy of BLI1100 formulations to~     placebo for the treatment of moderate to severe acne vulgaris.~   "
133841|NCT01815437|"~     This study will evaluate how much vitamin D is present in a mushroom supplement. This~     supplement contains an extract from mushrooms that have been exposed to sunlight. The~     mushroom supplement will be compared to non-commercially available vitamin D supplements~     produced in a Goo Manufacturing Practices (GMP)-licensed facility.~   "
133842|NCT01815424|"~     The primary objective of this study is to compare the efficacy of CP-690,550 (5 mg BID and 10~     mg BID) versus placebo for the reduction in severity of plaque psoriasis after 16 weeks of~     treatment in Asian subjects with moderate to severe chronic plaque psoriasis who are~     candidates for systemic therapy or phototherapy.~   "
133843|NCT01815411|"~     Rheumatoid Arthritis (RA) is a chronic, autoimmune inflammatory disease that leads to~     significant pain, joint destruction and functional decline, and has a substantial economic~     impact both for sufferers and society. Although the etiology of RA is unknown, it is~     generally accepted that it arises from an interplay of genetic predisposition (in particular,~     HLA-DR allele subtypes and specific gene polymorphisms), immunological deregulation (e. g.~     autoantibody production), and environmental factors. The prevalence and incidence of RA in~     Norway is estimated to 0,4-0,5 % and 0,020-0,025 %, respectively, and incidence rates are~     2-4-fold higher in women. Synovitis and bone resorption are key pathogenetic factors in RA~     and these patients have elevated cytokine levels in joints and blood (i.e. TNF, IL-1, IL-6).~     RA is also associated with significant comorbidity; the most important is premature~     cardiovascular disease that significantly contributes to increased mortality. Compared with~     the general population, mortality in RA is from 1,57-2,0-fold higher in Norway and Sweden,~     and their mean life expectancy is reduced by an average of 5-10 years. Medical treatment of~     RA consists of nonsteroidal anti-inflammatory drugs, systemic glucocorticosteroids,~     traditional disease modifying antirheumatic drugs (including methotrexate) and biologic~     therapies (including anti-tumor necrosis factor (TNF) α, anti-IL 6 and anti-CD20 therapy).~     Also, a considerable portion of the patients are in need of joint replacement surgery and in~     need of rehabilitation.~      However, the treatment opportunities are still not optimal. In a large proportion of the~     patients, full control of the disease is not possible due to limited effect of available~     therapies and/or intolerance to these therapies. Therefore, there is a huge need to find new~     therapeutic alternatives to treat RA.~      Since studies on healthy volunteers and IBD-patients support that the mushroom extract~     AndoSanTM exert an anti-inflammatory effect in vivo, the investigators wanted to examine in a~     pilot study whether this effect also was evident in patients with RA. A potential~     anti-inflammatory effect could prove beneficial in these seriously ill patients, who~     accordingly could experience less side effects (edema, granulocytopenia, diminished tissue~     repair) due to potential reduction number and dose of disease modifying drugs.~   "
133844|NCT01815398|"~     Many young people who are homeless have cognitive deficits which impede their ability to~     secure and maintain employment. This study looks to see if targeting cognitive deficits can~     improve cognition and vocational outcome.~   "
133845|NCT01815385|"~     Metabolic diseases such as obesity and diabetes are modern day epidemics. Early life exposure~     to an adverse developmental environment, including environmental toxins, are linked to~     increased susceptibility to obesity, metabolic syndrome and type 2 diabetes. Although the~     mechanisms underlying the fetal origins of metabolic disease are poorly understood, strong~     evidence suggests that alterations in the epigenome play a critical role in this process. The~     central hypothesis of this proposal is that intrauterine exposure to benzo[a]pyrene leads to~     epigenetic changes which will have functional consequences and may be a marker for, or may~     contribute to, increased susceptibility to adverse outcomes in childhood including increased~     adiposity and the subsequent development of obesity, metabolic syndrome or diabetes. The~     goals of this proposal are to: 1) determine benzo[a]pyrene levels in umbilical cord blood of~     newborns, 2) determine whether benzo[a]pyrene exposure during pregnancy correlates with early~     onset of obesity and metabolic disease by examining the children at 12 and 24 months of age,~     3) determine whether in utero benzo[a]pyrene exposure programs metabolic disease through~     alterations in DNA methylation and gene expression, and 4) determine the plasticity of the~     DNA methylation patterns in the same offspring at 12 months of age. The long-term goal of~     this project is to define biomarkers that identify neonates at high-risk for diminished~     attainment of full health potential, who can then be targeted for preventative measures.~   "
133846|NCT01815372|"~     Background and aims: Ultrasound-guided (USG) nerve blocks of the sciatic nerve (popliteal~     level = PL) and the saphenous nerve (mid-femoral level = MFL) provides analgesia following~     leg surgery. Traditionally two separate injections are performed. The aim was to describe a~     novel, faster USG block combination requiring only one skin penetration to block the sciatic~     and saphenous nerves; i.e. the SPEDI block = Single PEnetration Dual Injection.~      Methods: A randomized, controlled and double-blinded trial. Following ethics committee~     approval 60 patients will be randomized to the administration of an USG SPEDI block compared~     to two separate USG blocks of the saphenous (MFL) and sciatic (PL) nerves. Blocks will be~     performed after induction of general anaesthesia. Outcome measures will be performance time~     (primary outcome measure), Post-Anaesthesia Care Unit pain scores (VAS scores 0-10), block~     difficulty level (easy, middle, difficult), opioid consumption (in the PACU),~     serum-ropivacaine pharmacokinetics (blood sample 0-180 minutes). Both block combinations will~     be evaluated by MR imaging (MRI).~      Hypothesis: The USG SPEDI block combination is expected to be performed significantly faster~     without moving the leg, and achieve successful perioperative pain management. The SPEDI block~     may find important use in the emergency setting.~   "
134406|NCT01808027|"~     To investigate the causes of hospital variation in outcomes from acute coronary syndromes in~     England and develop recommendations for improving patient care.~   "
133849|NCT01815333|"~     The goal of this clinical research study is to learn if the drug Feraheme ® (ferumoxytole)~     helps researchers most clearly to see cancerous lymph nodes on an MRI scan. Researchers~     also want to learn if ferumoxytole may be used in liver imaging.~      Ferumoxytole is designed to deliver iron to treat iron-deficiency anemia (low red blood cell~     counts) in patients with chronic kidney disease. In this study, it will be used as an MRI~     contrast. Contrasts are used by doctors in order to see MRI images more clearly.~   "
133850|NCT01815320|"~     Acute allograft dysfunction is often observed in the first weeks after kidney~     transplantation. Renal biopsy is universally considered the gold standard procedure for~     differential diagnosis of acute allograft dysfunction secondary to intraparenchymal causes.~     Kidney biopsy, however, is an invasive procedure that is time and cost consuming. Moreover,~     it may but not contribute to clinical diagnosis in about 10% of cases because of the~     impossibility to perform the analysis or of inadequacy of the biopsy sample. Availability or~     readily applicable non-invasive procedures might therefore allow increasing the performance~     of differential diagnosis of allograft dysfunction. In the recent years, a novel US imaging~     technique, namely contrast-enhanced ultrasound (CE-US),has been developed. The agent used in~     this study, Sonovue microbubbles consist of a central sulphur hexafluoride core with a~     surrounding phospholipid monolayer and last for several minutes in the systemic circulation~     before spontaneous degradation with absorption of the gaseous component by the lungs and the~     phospholipid shell by the liver. With the use of gasfilled microbubbles that act as~     scatterers within the blood stream and the development of low-MI ultrasound techniques that~     allow the visualization of the bubbles without destroying them, it is possible to improve the~     depiction of vessels and have access to structural and functional information on the~     microcirculation. Moreover SonoVue microbubbles are not nephrotoxic and can be safely used to~     evaluate kidney disfunction.~      Thus, whether a. different patterns of parenchymal perfusion detected by CE-US can be~     associated with different patterns of renal graft involvement during acute renal function~     deterioration and b. whether, conversely, different patterns of parenchymal perfusion~     detected by CE-US may help predicting different patterns of renal involvement will be~     investigated in 20 deceased or living donor kidney graft recipients.~   "
133851|NCT01815307|"~     To compare efficacy and safety of Gemcitabine versus S-1 adjuvant therapy after~     hemihepatectomy.~   "
133852|NCT01815294|"~     The purpose of this study is to support the qualification of a replacement manufacturing site~     for DOXIL/CAELYX (doxorubicin HCL).~   "
133853|NCT01815281|"~     The purpose of this research study is to evaluate safety and effectiveness of Foot Mechanical~     stimulation to improving Gait and Gait Related Disorders in Parkinson Disease and Progressive~     Supranuclear Palsy both stable and with motor fluctuation.~   "
133854|NCT01815268|"~     The purpose of this study is to prospectively evaluate relative effectiveness of high dose~     influenza vaccine in preventing influenza mortality, hospitalization, and functional decline~     in a nursing home population in the U.S., compared to the standard dose trivalent seasonal~     influenza vaccine.~   "
133855|NCT01815255|"~     This study will assess the safety and efficacy of generic TDF from Governmental~     Pharmaceutical Organization (GPO) in HIV-infected children~   "
133856|NCT01815242|"~     The trial will evaluate the optimal treatment with nab-paclitaxel in combination with either~     carboplatin or gemcitabine for patients with triple negative breast cancer.~   "
133857|NCT01815229|"~     Patients will undergo placement of an endotracheal tube (ETT) as standard of care. Tracheal~     lavage will be conducted using 5 mL of sterile saline solution by a push/suction technique.~     Specimen samples obtained by wall suction will be collected at 2 time points following~     intubation.~      Blood samples will be obtained at 2 time points, simultaneous with the collection of the~     tracheal specimens.~   "
133858|NCT01815216|"~     After obesity surgery gastric bypass (GBP) patients usually lose more than 50% of its former~     preponderance in relative short time (~ 2 years). But knowledge of the underlying biological~     mechanisms of decline in body weight is still inadequate.~      This project intends to examine patients' background activity in the brain (i.e. the resting~     state activity) and brain volume using MRI both before and one year after surgery.~   "
133859|NCT01815203|"~     With the abundance of energy-dense foods that are designed for ease of consumption in the~     current environment, it is of importance to better understand the factors that may undermine~     the control of energy intake at healthy levels.~      One of the factors that is potentially important in response inhibition is caffeine.~      The aim is to assess the direct effects of caffeine on response inhibition, using a No~     Go/Go-task. We will also assess whether the presentation of food cues, i.e. as words or as~     pictures, modulate response inhibition different in restrained vs. non-restrained eaters.~   "
133860|NCT01815190|"~     Cutaneous vasculitis due to vascular deposition of large circulating immune complexes is a~     disease frequently seen by general practitioners and dermatologists. The clinical symptom is~     palpable purpura with predilection for the lower legs.~      In some cases vasculitis also affects systemic organs, such as the kidneys and the intestine.~      When the immune complexes contain immunoglobulin class A (IgA) and when there is systemic~     involvement, the disease has been referred to as Henoch Schönlein purpura.~      When there are no signs of systemic involvement, the disease has been referred to as~     cutaneous leukocytoclastic angiitis.~      The investigators hypothesize that palpable purpura with predilection for lower legs is a~     pathognomonic clinical sign for immune complex vasculitis in both IgA vasculitis and~     IgA-negative vasculitis, but that only the presence of IgA in immune complexes is likely to~     be associated with systemic involvement and therefore warrants more extensive diagnostic~     procedures Vice versa the investigators postulate that the presence of IgG or IgM without IgA~     in immune complexes excludes systemic involvement The investigators also want to investigate~     to which of the 2 groups patients with palpable purpura and negative immunofluorescence~     should be assigned.~   "
133861|NCT01815177|"~     Arthroscopic transosseous fixation of rotator cuff tears has become an alternative to~     arthroscopic suture anchor.~      This novel technique that allows surgeons to perform a standardized arthroscopic transosseous~     (anchor free) repair of rotator cuff tears can improve postoperative pain and reduce the~     incidence of shoulder stiffness.~      The aim of the this study is to compare clinical outcomes of two groups of patients: patients~     that received an arthroscopic transosseous fixation using the ArthroTunneler tunneling device~     (Tornier Inc, Edina, Minnesota) versus patients that received an arthroscopic rotator cuff~     repair using suture anchors.~   "
133886|NCT01814826|"~     This study is an open-label, multicenter, phase 1b, dose-escalation study of MLN4924 in~     combination with azacitidine in adult patients with AML. The patient population will consist~     of patients 60 years of age or older, previously diagnosed with World Health~     Organization(WHO)-defined AML, who are unlikely to benefit from standard induction therapy~     and who have not received definitive treatment for AML or prior treatment with azacitidine or~     decitabine.~   "
133862|NCT01815164|"~     Aim: Gut directed hypnotherapy can reduce IBS symptoms but the mechanisms underlying this~     therapeutic effect remain unknown. We determined the effect of hypnotherapy and educational~     intervention on brain responses to cued rectal distensions in IBS patients. Methods: 44 women~     with moderate to severe IBS and 20 healthy controls (HCs) were included.. Blood oxygen level~     dependent (BOLD) signals were measured by functional Magnetic Resonance Imaging (fMRI) during~     expectation and delivery of high (45 mmHg) and low (15 mmHg) intensity rectal distensions.~     Twenty-five patients were assigned to hypnotherapy (HYP) and 16 to educational intervention~     (EDU). 31 patients completed the treatments and the post treatment fMRI. Results: Similar~     symptom reduction was achieved in both groups. HYP responders demonstrated a pre-post~     treatment BOLD attenuation in both anterior and posterior insula during high intensity~     distension, while EDU responders had a BOLD attenuation in prefrontal cortex. Pre-post~     differences for the low distension and for the two expectation conditions were almost~     exclusively seen in the HYP group. For all responders there was a significant correlation~     between treatment induced reduction of GI related anxiety and BOLD decrease in the anterior~     insula. Following treatment, the brain response to distension was similar to that observed in~     HCs, suggesting that the treatment had a normalizing effect on the central processing~     abnormality of visceral signals in IBS. Conclusions: The abnormal processing and enhanced~     perception of visceral stimuli in IBS can be normalized by psychological interventions.~     Symptom improvement in the treatment groups may be mediated by different brain mechanisms.~   "
133863|NCT01815138|"~     This a prospective randomized double blind study involving patients at high risk of OHSS~     development with peak serum E2 levels < 4,000 pg/ml comparing the ongoing pregnancy rates in~     patients who receive adjuvant hCG 1,000 IU at the time of GnRH agonist trigger or adjuvant~     hCG 1,500 IU 35 hours after GnRH agonist trigger.~   "
133864|NCT01815125|"~     Background: Most patients suffering from mild Traumatic Brain Injury (mTBI) present~     persistent symptoms at one week post injury. A systematic review showed a paucity of studies~     for short term outcomes following mTBI. Among potential treatments for mTBI, ondansetron has~     shown promising results based on clinical experience and a single retrospective study.~     Objectives: The primary objective of this pilot study is to determine the feasibility of a~     randomized controlled trial evaluating the effect of ondansetron to decrease post concussion~     symptoms at one week following mTBI in children. More specifically, this pilot study will~     evaluate the proportion of participants who complete assessment at one week following~     intervention. Method: This will be a randomized, double blinded, controlled trial performed~     among children aged between 8 and 17 years old who sustained a mTBI in the previous 24 hours.~     Participants visiting the emergency department will be randomized to receive one dose of~     either ondansetron or placebo. The primary outcome of interest is defined as an increase from~     pre-concussion baseline of at least 3 symptoms from the Post Concussion Symptom Inventory~     (PCSI) one week following trauma. Secondary outcomes will include time to full recovery, mean~     PCSI score, and outcomes at one month following head trauma. The primary analysis will~     compare the proportion of participants with persistence of symptoms at one week in both~     groups. The full study sample size was calculated to have 90% power to detect a decrease in~     the proportion of persistence of symptoms from 50% to 30% with an alpha value of 0.05.~     Approximately 126 patients will therefore be recruited in each arm. The investigators plan to~     recruit 30 participants (10% of the final population) for the pilot study. Expected results:~     This pilot study should confirm the feasibility of the randomized controlled trial by showing~     that 90% of the recruited participants provide data on the primary outcome at one week~     following intervention. On the long term, the investigator expect that ondansetron will~     decrease the proportion of patients sustaining persistent symptoms of concussion from 50% to~     lower than 30%.~   "
133865|NCT01815112|"~     The physio-pathology of Alzheimer's disease (AD) remains unknown and there is no cure. Thus,~     the search for objective markers of preclinical first signs of cognitive impairment, is~     currently a major public health issue. Early detection of the disease is a major challenge to~     hope to slow or even stop the neurodegenerative process before the stage of dementia.~      In AD the investigators observe:~        -  A reduction in the volume of brain hippocampi associated with an alteration of the~          diffusion of water molecules in the white matter.~        -  A structural brain degeneration coupled with a decrease in cerebral glucose metabolism.~      Recent publications show that cerebrospinal fluid (CSF)flow is also altered, probably due to~     dysfunction of the choroid plexus. Hence the potential interest to study is, in addition to~     conventional imaging, the imaging of CSF dynamics and choroid plexus metabolism. In that~     aim,the investigators use two imaging modalities:~        -  Magnetic resonance imaging (MRI) is used to assess blood and CSF flow in the brain~        -  Positron emission tomography (PET) is used to assess glucose metabolism in grey/white~          matter and also in choroid plexus.~      The investigators expect that, because of choroid plexus atrophy in AD, CSF flow would be~     altered as well as glucose metabolism dynamic in choroid plexus.~   "
133866|NCT01815099|"~     We are investigating the feasibility and efficacy of transcranial magnetic stimulation (TMS)~     for patients with GAD who were placebo nonresponders in DIEF003523.1.~   "
133867|NCT01815086|"~     The purpose of the study is to determine the capability of a radiolabeled amyloid-reactive~     monoclonal antibody (mAb) to document the presence and distribution of amyloid deposits by~     PET/CT imaging in patients with AL amyloidosis.~   "
133868|NCT01815073|"~     The purpose of this study is to observe the occurrence of adverse events and seroconversion~     rate, geometric mean titres (GMTs) of live attenuated varicella vaccine，live attenuated JE~     vaccine and live attenuated varicella vaccine combined with live attenuated JE vaccine,~     respectively.~   "
133869|NCT01815047|"~     The goal of this study is to characterize the function and efficacy of the bioactive~     nutrient, vitamin D, in relation to infection and inflammatory status across pregnancy. The~     three specific aims of this study are 1) To address the impact of maternal vitamin D status~     on inflammation and infections across pregnancy using retrospective data, 2) To address the~     impact of vitamin D supplementation on maternal vitamin D status, inflammation and infections~     across pregnancy using prospective data and 3) To assess the impact of maternal vitamin D~     status during pregnancy on inflammatory mediators at the level of the placenta.~   "
133870|NCT01815034|"~     Use of trancutaneous CO2 (TC02) monitoring to aide in titration of sedation of midazolam and~     fentanyl. Trancutaneous readings validated with invasively obtained specimens from existing~     arterial sheaths required during AF and VT ablations (trans-septal and retrograde aortic~     respectively)~   "
133887|NCT01814813|"~     This randomized phase II trial studies how well giving vaccine therapy with or without~     bevacizumab works in treating patients with recurrent glioblastoma multiforme that can be~     removed by surgery. Vaccines consisting of heat shock protein-peptide complexes made from a~     person's own tumor tissue may help the body build an effective immune response to kill tumor~     cells that may remain after surgery. Monoclonal antibodies, such as bevacizumab, can block~     tumor growth in different ways. Some block the ability of tumor cells to grow and spread.~     Others find tumor cells and help kill them. It is not yet known whether giving vaccine~     therapy is more effective with or without bevacizumab in treating glioblastoma multiforme.~   "
133871|NCT01815021|"~     Primary objective:~      Phase I Proof of concept: treatment with smaller doses of elemental calcium from ACC compared~     to CCS can maintain target serum calcium (corrected for albumin) values (7.0-10.0 mg/dL).~      Phase II To test the hypothesis that treatment with smaller doses of elemental calcium from~     ACC compared to CCS can maintain target serum calcium (corrected for albumin) values~     (7.0-10.0 mg/dL).~      Secondary objectives:~      Phase I~        -  ACC dose selection - to confirm the conversion factor of ACC from CCS~        -  To determine the effect of food on ACC absorption~      Phase II~        -  To test the hypothesis that treatment with smaller doses of elemental calcium from ACC~          compared to CCS will not cause an increase in hypercalciuria in patients with~          hypoparathyroidism~        -  To test the hypothesis that smaller doses of elemental calcium from ACC can reduce the~          side effects related with high calcium consumption.~      Amorphical has a strong basis to believe that the ACC product is better absorbed compared to~     the commercially available CCS products and therefore, can maintain desirable target albumin~     corrected calcium values in serum (CA) with smaller doses of elemental calcium from ACC. As~     results, the burden of taking high doses of calcium supplementation along with the side~     effects of the standard therapy (gastrointestinal discomfort and hypercalciuria) will be~     reduced.~      Testing serum CA and urine calcium values in subjects with hypoparathyroidism may provide a~     straightforward method to test this hypothesis.~      The study is designed to be conducted with extra precaution in order to avoid disturbing the~     fragile balance between CA levels in serum and calcium levels urine. The crossover design of~     phase II of the study allows a more accurate and reliable comparison of results attributable~     to the specific treatment within the same individual. In addition, the subjects will continue~     consuming all their routine medication throughout the trial. The subjects in the control arm~     will consume their routine calcium supplement doses thus, will be treated with a standard of~     care.~   "
133872|NCT01815008|"~     This clinical trial is examining the role of genetic polymorphism on the effect of~     clopidogrel (with or without aspirin) on platelet response in persons at high-risk for~     myocardial infarction or stroke due to family history of early-onset coronary artery disease.~   "
133873|NCT01814995|"~     Women with a history of 'diabetes in pregnancy' or Gestational Diabetes (GDM) have a high~     risk for type 2 diabetes later in life. This can often be prevented, however, with~     improvements in eating habits and higher physical activity levels. However, many women find~     it difficult to alter their lifestyle habits, especially if they have young children. In~     adults with type 2 diabetes, the investigators have been studying the effects of combining~     nutrition education with meal preparation training and pedometer-based self-monitoring to~     improve eating habits and increase activity levels. The investigators have shown that such a~     strategy can reduce hemoglobin A1C by 0.3% and correlates with small reductions in weight~     (Dasgupta et al, International Journal of Behavioural Nutrition and Physical Activity, 2012).~     In developing the present interventional study, we presented this strategy to women with a~     GDM history and asked them how they would modify it to suit their needs. They expressed~     strong interest in such an approach but emphasized a need to involve their spouses and~     provide childcare support. They did not express interest in use of meal replacements.~     Therefore, in MoMM-intervention phase, the investigators will examine the effects of a once~     per month (4 session) program combined with Internet/telephone-based support. The four~     sessions with include meal preparation training, strategies to limit mindless eating and~     improve meal content and portion control. All sessions will offer child care. Two sessions~     will involve spouses. The investigators will assess effects on weight, BMI, DXA measures of~     fat, and measures of insulin resistance and blood pressure. This single-arm intervention~     study may lead ultimately to a randomized controlled trial.~   "
133874|NCT01814982|"~     The purpose of this study is to evaluate safety, tolerability, pharmacokinetics (explores~     what the body does to the drug) and pharmacodynamics (the study of the action or effects a~     drug has on the body) of JNJ-17299425 in participants with traumatic brain injury (acute and~     chronic injuries to the brain, including the cerebral hemispheres, cerebellum, and brain~     stem).~   "
133875|NCT01814969|"~     Clinical objective of the study is to compare the rates of pathologic response, acute~     toxicity and sphincter preservation with two schedules of preoperative regiment in patients~     with locally advanced rectal cancer.~   "
133876|NCT01814956|"~     Aim is to investigate the influence of an early supply of parenteral nutrition including a~     fish oil containing lipid emulsion on the course of acute lung injury in the intensive care~     unit. In comparison, a standard parenteral nutrition with a soybean oil based emulsion will~     be used. Data obtained in this trial may provide evidence for a beneficial effect of fish oil~     derived omega-3 fatty acids in parenteral nutrition regarding their influence on acute lung~     injury.~   "
133877|NCT01814943|"~     This study is conducted in a cohort of low dose aspirin (ASA) users previously ascertained.~     The aims of the post hoc analyses are:~      To estimate the incidence of uncomplicated peptic ulcer (UPU) in a cohort of low-dose ASA for~     secondary prevention of vascular disease and the relative risk of UPU associated with use and~     discontinuation of use of low dose ASA.~      To estimate the effect of proton pump inhibitors (PPI) on the occurrence of UPU among users~     of low-dose ASA for secondary prevention of vascular disease To evaluate the effect of other~     risk factors on the occurrence of UPU among users of low-dose ASA for secondary prevention of~     vascular disease.~   "
133878|NCT01814930|"~     Postpartum contraceptive counseling varies widely in its provision; no standardized practice~     has been well-established by the literature. We intend to evaluate how directed postpartum~     contraceptive counseling to adolescents aged 14-19 affects key outcomes over time. Subjects~     will be randomized to receive either the standardized contraceptive counseling intervention~     or routine postpartum care. We will then assess the difference in repeat pregnancy rates~     between the two groups~   "
133879|NCT01814917|"~     The Primary Objectives of this study are to assess the long-term efficacy of treatment with~     colestilan (MCI-196) (including combination therapy) and to assess the long-term safety of~     treatment with colestilan (MCI-196) (including combination therapy).~   "
133880|NCT01814904|"~     The Primary Objective of this study is to determine the initial starting doses of colestilan~     (MCI-196) in paediatric subjects with Chronic Kidney Disease Stage 5 on Dialysis and with~     Hyperphosphataemia.~   "
133881|NCT01814891|"~     Determination of liver stores of vitamin A will be determined before and after consumption of~     high pro-vitamin A orange maize, compared to low provitamin A white maize.~   "
133882|NCT01814878|"~     The purpose of this study is to compare the efficacy and safety of extended release (ER)~     tramadol hydrochloride (HCl)/acetaminophen with immediate release (IR) tramadol~     HCl/acetaminophen in participants with moderate to severe (very serious, life threatening)~     postoperative pain.~   "
133883|NCT01814865|"~     This study is being offered to patients who are post-menopausal, have breast cancer with a~     positive estrogen and/or progesterone hormone receptor test and are currently awaiting~     surgery for breast cancer.~      The purpose of this study is to determine whether abiraterone acetate has different hormonal~     and genomic effects than non-steroidal aromatase inhibitors in the treatment of~     post-menopausal hormonal receptor positive primary operable breast cancer~   "
133889|NCT01814787|"~     Increasing rates of type 2 diabetes among children and adolescents has considerable long-term~     implications not only for the affected individuals, but also for society and the health~     system as a whole. Pediatricians have unique and important opportunities to screen for type 2~     diabetes and to promote lifestyle modification for those children identified with~     pre-diabetes; yet implementation of these practices within the pediatric primary care setting~     is far from ideal. The purpose of this study is to implement the ADA screening guidelines for~     type 2 diabetes and clinical management prompts within a pediatric primary care setting using~     a computer decision support system (CDSS) developed by the investigators research group - the~     Child Health Improvement through Computer Automation (CHICA) system. The investigators~     hypothesize that the coupling of CDSS with ADA guidelines will result in greater compliance~     with ADA recommended screening procedures as well as better clinical management of children~     identified as having pre-diabetes or type 2 diabetes.~   "
133890|NCT01814774|"~     This study is a retrospective chart review to evaluate the doses of botulinum Type A toxins~     BOTOX® (onabotulinumtoxinA) and Xeomin® (incobotulinumtoxinA) used for the treatment of~     Cervical Dystonia and Blepharospasm in clinical practice.~   "
133891|NCT01814761|"~     This is a study of bimatoprost 0.01% (LUMIGAN® 0.01%) in subjects with primary open-angle~     glaucoma (POAG) or ocular hypertension (OH) who require further treatment for elevated~     intraocular pressure (IOP).~   "
133892|NCT01814748|"~     This study will examine the safety and efficacy of once-weekly omarigliptin in participants~     18 to <45 years of age with Type 2 diabetes mellitus and inadequate glycemic control. The~     study hypothesis is that treatment with omarigliptin compared with placebo provides greater~     reduction in hemoglobin A1c (A1C) in participants after 24 weeks.~   "
133893|NCT01814735|"~     Currently, India has the largest absolute number of people with diabetes in the world, and~     evidence indicates that consumption of whole-grains can decrease diabetes by improving~     glycemic control. Our study will evaluate the efficacy of substituting brown rice, a~     whole-grain, for white rice in Chennai, India, on biomarkers of diabetes risk. The ultimate~     goal of this research is to provide data for use in designing a global dietary intervention~     study aimed at reducing diabetes risk through simple, culturally appropriate, feasible and~     sustainable dietary changes.~   "
133894|NCT01814722|"~     This is a multi-center, longitudinal observational study of adult human immunodeficiency~     virus (HIV) participants at academic and community-based practices in the United States who~     are switching from first-line to second-line therapy. The study's primary hypothesis is that~     HIV participants switching to raltegravir-based regimens will have better Medical Outcomes~     Study-HIV (MOS-HIV) Health Survey scores than participants switched to non-nucleoside reverse~     transcriptase inhibitor (NNRTI)-based or protease inhibitor (PI)-based regimens.~   "
133895|NCT01814709|"~     This open-label, two-arm, drug interaction study will investigate the effect of~     co-administration of rifampin or itraconazole on the pharmacokinetics of GDC-0032 in healthy~     volunteers. In Arm A, volunteers will receive GDC-0032 and rifampin; in Arm B, volunteers~     will receive GDC-0032 and itraconazole. The anticipated time on study treatment is~     approximately 30 days.~   "
133896|NCT01814696|"~     The goal of this pilot study to evaluate the effect of the MedSentry system, a multi-faceted~     medication adherence device and reminder system, on medication adherence and clinical~     outcomes in heart-failure (HF) patients. We will also evaluate the usability and satisfaction~     derived from using this system.~      We hypothesize that:~        1. The use of the MedSentry system will improve medication adherence in patients with a~          discharge diagnosis of HF.~        2. The improvement in adherence correlates with fewer hospitalizations and emergency~          department (ED) visits.~        3. The improvement in adherence correlates with better health-related quality of life.~   "
133897|NCT01814683|"~     The main determinant of primaquine efficacy is the total dose of primaquine administered,~     rather than the dosing schedule. Previous trials have demonstrated that the standard low dose~     regimen of primaquine (3.5 mg/kg total) fails to prevent relapses in many different endemic~     locations. For this reason the 2010 WHO antimalarial guidelines now recommend a high dose~     regimen of 7 mg/kg (equivalent to an adult dose of 30mg per day), although many countries~     still recommend lower doses for fear of causing more serious harm to unscreened G6PDd~     patients.~      Shorter courses of higher daily doses of primaquine have the potential to improve adherence~     and thus effectiveness without compromising efficacy. Primaquine also has relatively weak but~     clinically relevant asexual stage activity against P. vivax so larger daily doses may~     substantially augment chloroquine's blood stage activity at low levels of resistance. In~     Thailand directly observed primaquine (1mg/kg/day) administered over 7 days was well~     tolerated and reduced relapses by day 28 to 4%. This is encouraging but not definitive since~     many relapses present after one month. Longer follow-up is needed to distinguish whether~     relapse was prevented or deferred. If the efficacy, tolerability and safety of short-course,~     high-dose primaquine regimens can be assured across the range of endemic settings, along with~     reliable point-of-care G6PDd diagnostics, then this new primaquine regimen would be a major~     advance in malaria treatment improving adherence to and thus the effectiveness of~     anti-relapse therapy.~      Due to the long duration of standard primaquine treatment regimens, courses are difficult to~     supervise, are poorly adhered to and lack effectiveness. This proposed multicentre randomised~     clinical trial will provide evidence across a variety of endemic settings on the safety and~     efficacy of high dose-short course primaquine in G6PD normal patients. In a parallel single~     arm study the investigators will also gather safety data on the use of weekly primaquine in~     patients with G6PDd. This study aims to generate evidence that will directly inform global~     public health policy for the radical cure of P. vivax. A better understanding of the risks~     and benefits of primaquine is crucial in persuading policy makers and clinicians of the~     importance of the radical cure of vivax malaria that will reduce the parasite reservoir and~     decrease transmission.~   "
133898|NCT01814670|"~     A study to evaluate safety and efficacy of treatment with botulinum toxin Type A (BOTOX®) in~     Chinese patients with moderate to severe frown lines (Glabellar Rhytides) previously treated~     with facial laser resurfacing.~   "
133919|NCT01814397|"~     Postmenopausal women who have hormone receptor positive breast cancer are typically treated~     with aromatase inhibitor medications, which substantially decrease the amount of estrogen~     produced by their bodies. These medications are fairly well tolerated, but can cause aches~     and pains which can be quite severe in some cases.~      People experience pain differently. Estrogen appears to play a role in how we experience~     pain. Therefore, decreasing estrogen levels may lead to more pain in some women than others.~     The goal of this study is to evaluate perception of pain in women with breast cancer, and to~     determine if differences in pain perception lead to more aches and pains in some women~     treated with aromatase inhibitors.~      In this study, we plan to enroll 55 women with breast cancer who are starting treatment with~     an aromatase inhibitor. Participants will undergo testing to evaluate their perception of~     pain, and will also complete a set of questionnaires. Testing will be conducted before~     starting aromatase inhibitor therapy, as well as after 3 and 6 months of therapy. We will~     investigate whether pre-existing differences in pain perception lead to different amounts of~     pain during aromatase inhibitor therapy.~   "
133899|NCT01814657|"~     This study is for patients undergoing In Vitro Fertilization (IVF). The investigators are~     studying the best way to control pain during the egg retrieval process. The egg retrieval~     involves passing a needle under ultrasound guidance through the vagina into the ovaries to~     remove eggs that are to be later fertilized. Patients often report this as very~     uncomfortable.~      Different fertility clinics across the country use different methods of pain control. All~     clinics will use intravenous medication to control pain, while some may or may not use local~     anaesthetic (freezing) in the vagina. Our goal is to find the best way to control pain. Since~     local anaesthetic injection involves multiple needle punctures and may be painful, the~     investigators are unsure if local anaesthetic is necessary in addition to the intravenous~     pain medication.~      The investigators will conduct a randomized trial where all patients will receive intravenous~     pain medication, but some will receive local anaesthetic injection and some will receive~     placebo injection. Patients will be asked to complete a questionnaire on their pain~     experience after oocyte retrieval. The investigators will then analyze the data and determine~     whether local anaesthetic actually improves pain when patients are already receiving~     intravenous pain medications. Through our study, the investigators aim to improve the pain~     experience of all women undergoing IVF in the future.~   "
133900|NCT01814644|"~     This project will test the efficacy of the TRIMM (Tailored Rapid Interactive Mobile~     Messaging) program, a user‐friendly, semi‐individualized text-messaging intervention to~     facilitate lifestyle change and weight loss among obese African-American adults with or at~     risk for diabetes, in a pilot, controlled clinical trial.~      The text-messaging intervention will be in addition to, and compared with traditional diet,~     behavior, and physical activity education. Tips will be designed to increase knowledge,~     skills, and motivation.~   "
133901|NCT01814631|"~     The primary objective for this study is to compare the image quality of two endoscopic~     ultrasound (EUS) processors used for imaging of the pancreas. Processor images are used to~     make a correct clinical diagnosis and higher quality imaging is related to more accurate~     results. Patient care may be improved due to the information collected as part of this study.~      The quality of imaging is of utmost importance for diagnosing early neoplasms in the pancreas~     and diseases such as chronic pancreatitis. Image quality is dictated by two factors: image~     resolution and depth of penetration. Good imaging enables diagnosis of early stage disease~     and thereby facilitates early treatment.~   "
133902|NCT01814618|"~     The purpose of this study is to determine if a trial of directed high-dose nasal steroids~     improves residual smell loss in patients with chronic rhinosinusitis following sinus surgery.~     Other outcomes of this study include: identifying the differences in sinus airflow between~     patients who improve following nasal steroid treatment and those who do not, and to see if,~     in patients who improve following surgery, the improvement remains throughout follow-up.~   "
133903|NCT01814605|"~     A new ultrasound-guided subgluteal space approach to sciatic nerve block that has been~     recently described obviates the need to identify the sciatic nerve. The investigators~     hypothesize that the use of an ultrasound-guided subgluteal space injection to perform~     sciatic nerve block will increase the proportion of patients experiencing complete sensory~     block in both terminal branches of the Sciatic nerve in comparison to the same proportion in~     those who receive the block via ultrasound-guided infragluteal approach with circumferential~     injection in patients scheduled for unilateral TKA(total knee arthroplasty) surgeries.~   "
133904|NCT01814592|"~     The aim of this study is to evaluate the effectiveness of total root coverage between two~     coronally positioned flap technique in Miller recession Class I and II, in patients attending~     at Universidad El Bosque dental school clinics.~   "
133905|NCT01814579|"~     This study is designed to determine if using the V-Loc Wound Closure System expedites~     operative time in robotic hysterectomy.~   "
133906|NCT01814566|"~     This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy~     of Chinese Medical Sciences in January 2013.~      It was funded by China major scientific and technological specialized project for~     'significant new formulation of new drugs'.~      DanshenDuofensuanyan is kind of Chinese Medicine injection used for treating coronary heart~     disease and angina pectoris in many Chinese hospitals.~      The purpose of this study is to determine adverse drug events or adverse drug reaction in~     large sample size 30,000 patients.~   "
133907|NCT01814553|"~     This is a non-randomized, open label, two-cohort, multi-institutional study to evaluate the~     use of diarrheal management tools intended to facilitate timely intervention and treatment~     modifications due to afatinib treatment-related diarrhea in patients with EGFR~     mutations-positive adenocarcinoma of the lung. Patients in Cohort 1 will follow diarrhea~     management. Patients in Cohort 2 will receive prophylactic loperamide starting the fist day~     of afatinib treatment.~   "
133908|NCT01814540|"~     The purpose of this study is to elucidate tolerability and effectiveness in consumption of~     the complex indigestible sugars from dairy products called bovine milk oligosaccharides (BMO)~     to enrich intestinal microflora toward beneficial populations.~   "
133909|NCT01814527|"~     Concussions are defined as a complex pathophysiological process affecting the brain, induced~     by traumatic biomechanical forces. Currently the standard of care in the treatment for~     concussions is cognitive and physical rest until symptoms resolve with a graduated return to~     activity. High dose omega-3 fatty acids have shown to have anti-inflammatory, anti-oxidant,~     and membrane stabilizing properties. They have also been used in treatment of severe~     traumatic brain injury. The purpose of this study is to determine if early high dose omega-3~     fatty acid supplementation in Division I National Collegiate Athletic Association (NCAA)~     athletes that have sustained a concussion will decrease the number of days out of competitive~     sports with a quicker symptom resolution, return to baseline neurocognitive functioning and~     postural stability using a randomized double blind placebo controlled study design. Once an~     athlete is identified as having sustained a concussion by the East Carolina University Sports~     Medicine staff and qualifies for the study, he/she will randomly be assigned to either high~     dose omega-3 fatty acid or placebo. Both groups will undergo standard and usual care for~     concussed athletes at East Carolina University. The number of days it takes the athlete to~     return to competitive athletics will be recorded, along with time to symptom resolution,~     normalization of their computerized neurocognitive testing (ImPact) and computerized postural~     stability testing (Biodex BioSway).~   "
133910|NCT01814514|"~     The AGV implant is designed to open when the IOP is between 8 mmHg and 10 mmHg, and thus~     maintains an IOP of 8 mmHg or higher. In the early period after glaucoma drainage device~     (GDD) surgery the intraocular pressure (IOP) classically goes through 2 phases. The~     hypotensive phase occurs immediately after surgery, lasts around 1 week. This is followed by~     the hypertensive period where the IOP tends to rise steadily above 21mmhg.~      The hypertensive response seems to occur more commonly after Ahmed GDD surgery than nonvalved~     implants, It was reported to occur in 40% to 80% of cases. Although the hypertensive phase~     can last as long as 6 months it is usually during the first 1 to 4 weeks, when there is~     intense congestion of the bleb wall, that IOP is highest.~      Previous study showed that when aqueous comes into contact with conjunctiva and Tenon's~     capsule,an inflammatory reaction occurs.Factors such as prostaglandins, eicosanoids, tissue~     growth factor beta (TGF β)has been shown to occur in glaucomatous aqueous. These mediators~     induce an inflammatory reaction, and if excessive, will result in fibrosis and poor~     functioning of the bleb. High pressure within the bleb also results in the secretion of TGF β~     by the bleb lining. It may result in inflammation of the bleb wall and subsequent fibrosis~     and poor bleb function. The investigators supposed that with early use of aqueous suppressant~     medication after AGV implantation, the concentration of inflammatory mediators decreased in~     subconjunctival space and may lead to better IOP control after shunt surgery.~   "
133911|NCT01814501|"~     This phase II trial studies how well panitumumab and combination chemotherapy works in~     treating patients with metastatic colorectal cancer previously treated with combination~     chemotherapy and bevacizumab. Monoclonal antibodies, such as panitumumab, can block tumor~     growth in different ways. Some block the ability of tumor cells to grow and spread. Others~     find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in~     chemotherapy, such as leucovorin calcium, fluorouracil, and irinotecan hydrochloride, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Giving panitumumab and combination chemotherapy together may kill more~     tumor cells~   "
133912|NCT01814488|"~     The experimental treatment consists in the application of a therapeutic strategy of~     allogeneic transplantation as a potential curative procedure in a population of patients with~     chemoresistant acute leukemias.~      Therapeutic intervention, namely the conditioning regimen as well as GVHD prophylaxis, are~     based on regimens currently in standard use in the context of allogeneic transplantation.~   "
133913|NCT01814475|"~     This study will be performed as a prospective multicenter phase II trial for compare~     busulfan-fludarabine reduced-intensity conditioning (RIC) with thiotepa-fludarabine RIC~     regimen prior to allogeneic transplantation of hematopoietic cells for the treatment of~     myelofibrosis.~      The primary endpoint for this study is to compare Progression Free Survival of two different~     RIC regimens for allogeneic stem cell transplantation in myelofibrosis.~      Progression Free Survival is defined as the time from the date of randomization to the date~     of the first documented disease progression or relapse (according to the International~     Working Group Consensus Criteria) or death due to any cause. Patients who have neither~     progressed nor died at the time of study completion or who are lost to follow-up are censored~     at the data of the last follow up for progression of disease for this study.~   "
133914|NCT01814462|"~     The present study aims to document and assess changes in single parameters of pulse wave~     analysis (ASI single parameters) as well as to evaluate ASI cardiovascular risk assessment~     before initiation of CPAP therapy and after 6 months of CPAP therapy in patients with~     obstructive sleep apnea.~   "
133915|NCT01814449|"~     The aim of our current study was to analyze whether 18F-labeled Fluoromisonidazole~     (1-(2-nitro-1-imidazolyl)- 2-hydroxy-3-fluoropropane [18F-FMISO]) PET/CT and expression of~     HIF-1-alpha could predict response of primary endocrine therapy in ER-positive breast cancer~   "
133916|NCT01814436|"~     Revitalization of Young Immature Permanent Teeth With Necrotic Pulps Using Autologous Stem~     Cells from Human Exfoliated Deciduous Teeth~   "
133917|NCT01814423|"~     Chloroquine (CQ) remains an alternative cheap, safe and widely available drug. Our previous~     research has shown that double (50 mg/kg) standard dose CQ given in split doses had a 95%~     efficacy and was well tolerated and safe. Still, safety could be an issue when the dose of CQ~     is increased. Severe adverse events are caused by high peak concentrations of CQ. Using split~     doses of CQ avoids high peak concentrations enabling the safe administration of high doses,~     however, pharmacokinetic data are lacking.~      Children included in the study will be given 50 mg/kg as split doses over 3 days or 70 mg/kg~     as split doses over 5 days. Treatment will be observed. Drug concentrations and adverse~     events will be monitored. On day 1, children and their mother/guardian will be requested to~     stay at the health centre between 9 am and 6 pm.~      Fifteen children aged 2-10 years with uncomplicated P. falciparum malaria and fulfilling the~     inclusion criteria will be recruited into each study arm.~      Following the end of treatment, the children will be seen on the morning of day 7, 14, 21 and~     28.~      Any child wishing to withdraw during the treatment phase and any child with reparasitaemia~     during the follow up will be given rescue treatment with arthemeter-lumefantrine or quinine~     according to treatment guidelines in Guinea-Bissau.~      Final analysis will include a description of included children, proportions of adverse events~     and any serious adverse events, drug concentrations and their relation to adverse events, the~     proportion of children withdrawn or lost to follow up, the cumulative PCR corrected and~     uncorrected success and failure rates on day 28 and the proportion of early, late clinical~     and late parasitological treatment failures.~   "
133918|NCT01814410|"~     There are mixed reports on nicotine's effects on ethanol-induced impairment in cognitive~     performance and behavior in humans. The main objective of this study is to characterize the~     interactive effects of acute intravenous (IV) ethanol and nicotine administration on~     cognition and behavior in healthy smokers. The general hypothesis is that nicotine will~     attenuate the negative effects of ethanol on cognition and subjective stimulant/sedative~     effects of ethanol.~   "
133995|NCT01813409|"~     The ACR Rheumatology Clinical Registry (RCR) is a tool developed to assist members in~     practice improvement, local population management, and efficient, successful participation in~     national quality programs. RCR integrates evidence-based quality measures aimed at improving~     care and drug safety for patients with rheumatoid arthritis, osteoarthritis, osteoporosis,~     gout and juvenile idiopathic arthritis.~   "
133920|NCT01814384|"~     Total knee arthroplasty represents over 70 000 surgical procedures per year in France,~     increasing about 10% each year since the early 1990s. Clinical experience shows a strong rate~     of success on pain relieve and improvement of knee articular function for these patients.~      Longevity of the implants had been proved to depend on the biomechanical design and~     implantation techniques, particularly the bone cuts during the surgery. To improve the~     precision of these cuts, the patient matched cutting blocks developed by Medacta company~     allows to adapt bone cuts to the patient anatomy improving the reliability of these~     procedure. A reduction of surgical time and bleeding would be another benefit expected with~     this type of ancillary. The objective of this study is to demonstrate the advantage of~     patient matched cutting blocks for total knee arthroplasty on realiability for both clinical~     and radiological criteria, morbidity reduction during and after the procedure and also a~     benefit on an economic point of view.~   "
133921|NCT01814371|"~     The purpose of this research study is to compare the effectiveness of commonly used~     decolonization treatments (application of mupirocin antibiotic ointment to the nose and~     bleach baths) when performed by individuals with a history of skin and soft tissue infection~     (SSTI) in the prior year (individualized approach) in comparison to decolonization of all~     household members (household approach) in an attempt to prevent Staphylococcus aureus skin~     infections. The investigators hypothesize an individualized decolonization approach will be~     equally as effective as a household approach to prevent SSTI.~   "
133922|NCT01814358|"~     Risk for heart and blood vessel diseases is increased when blood sugar rises. Blood vessel~     dysfunction is common to such diseases. Elevated blood sugar after eating promotes blood~     vessel dysfunction. Dietary factors other than carbohydrates influence rises and falls in~     blood sugar. Dietary protein is associated with improved blood sugar control. Whey protein~     effectively blunts the rise in blood sugar after consuming a carbohydrate rich drink/meal in~     normal weight and obese adults. This study will investigate the efficacy of drinking a whey~     protein beverage prior to eating for improved daily blood sugar control in normal weight and~     obese adults in the real world. Also, the study will test this dietary approach to reduce~     blood vessel dysfunction associated with eating a meal that causes blood sugar to rise. 24~     normal weight and 24 obese men and premenopausal women (18-50y) will participate. Subjects~     will wear a sensor to monitor daily blood sugar changes in response to their typically~     consumed diets for 2 days. Subjects will report to the UCLA CTRC the morning after the~     monitoring period for measurement of blood vessel function after eating a breakfast cereal~     meal. Blood samples will be obtained before and after the meal to measure relevant health~     markers. Subjects will repeat the 2-day diet and breakfast cereal meal challenge after a week~     or more, and will consume either a chocolate flavored 1) whey protein or 2) gelatin protein~     (control) shake prior to each meal. Neither subjects nor researchers will know which protein~     (double blind). Subjects will receive the alternate protein intervention after another week~     or more (crossover). We think drinking the protein shake prior to meals will reduce daily~     blood sugar rises and falls after eating and blunt the blood vessel dysfunction that results~     from eating the breakfast cereal.~   "
133923|NCT01814345|"~     Gastric cancer remains a major health issue and a leading cause of cancer death worldwide,~     although the prevalence and mortality of the disease have gradually decreased. The~     investigators have very few options for patients with advanced disease.~      The trastuzumab for Gastric Cancer (ToGA) trial, a pivotal randomized clinical trial of~     patients with HER-2 positive advanced, mostly metastatic, gastric cancer, proved the efficacy~     of trastuzumab (anti-Her 2 therapy) in combination with chemotherapy. The median overall~     survival was significantly prolonged in the trastuzumab-containing arm (13.8 vs. 11.1 months;~     HR 0.74; p=0.0046) without unexpected toxicity including cardiac events. The survival benefit~     was most pronounced in the subgroup of high HER-2/neu protein overexpression (median overall~     survival of 16 months). Only 20% of the patients screened and subsequently enrolled for this~     study were found to be HER2-positive when utilizing both immunohistochemistry and FISH. Her2~     testing is recommended for all patients with advanced gastric cancers and type III~     oesophageal adenocarcinomas.~      Data on Indian patients is lacking. Hence, the investigators plan to test for Her 2 in 100~     patients with IHC and FISH in 2+ and 3+ patients.~   "
133924|NCT01814332|"~     This purpose of this study is to look at the safety of the experimental drug GSK561679 as~     well as its effects on PTSD symptoms, thinking and memory, startle reaction, stress hormones,~     and mental health symptoms in comparison to placebo (an inactive substance).~   "
133925|NCT01814319|"~     Probenecid is an FDA approved drug for the treatment gout and hyperuricemia. It has been used~     safely in humans for decades for this and other indications. The investigators have recently~     discovered that this drug can also stimulate other receptors in the heart and therefore~     improve its function. The hypothesis of this study is that probenecid can be used to improve~     the function of the heart and therefore the symptoms in patients with heart failure.~   "
133926|NCT01814306|"~     There is no significant difference about success rate of two devices.~   "
133927|NCT01814293|"~     This is a nonblinded randomized controlled trial which is a survey-based comparison between~     supportive treatments for symptom relief from pediatric upper respiratory infection (URI).~     The primary objective of this study is to determine if the use of handheld humidifier~     improves URI symptom scores and/or reduces use of over the counter medications compared to~     other supportive treatments for pediatric URIs (ie. OTC cold medications, room air~     humidifier). Study duration is approximately 1 year and the individual intervention is 4~     days.~   "
133928|NCT01814280|"~     Background:~      Medication reviews performed on admission to hospitals reduce medication errors; however,~     evidence of effect on morbidity and mortality is currently inconsistent. It is known that~     patients' risks of experiencing medication errors are dependent on both patient- and drug~     factors, e.g. age, co-morbidity, number of drugs, risk of side effects.~      Aim and hypothesis:~      The aim of this pilot study is to study acute medical patients' risk of getting a medication~     error based on an algorithm that takes into account both patient and drug related factors.~     Secondary, the investigators will explore whether our methods are applicable in a randomised~     controlled trial. The investigators will also decide the number of patients in a randomised~     controlled trial based on this pilot study.~      The hypothesis is that an algorithm that has already been developed can stratify patients~     according to their risk of experiencing a medication error.~      Methods:~      100 acute admitted patients will be risk stratified at admission (>8 hours after). The~     patients who have highest risks of medication errors will receive a medication review~     performed by either a clinical pharmacist or a clinical pharmacologist.~   "
133929|NCT01814267|"~     The aim of the study is to assess the cost-effectiveness of telemedicine in the care of~     chronic diabetic foot ulcers.~      Patients will be randomized into 2 groups: 1/conventional care group with iterative visits to~     diabetes specialist or 2/innovative care (telemedicine group).~      the health insurance system perspective is adopted.~   "
133930|NCT01814254|"~     Estimation of hydration state in dialysis patients is a major challenge in clinical practice.~     Although many methods have been studied, none have been established yet for clinical routine~     practice.~      The investigators have developed a method, using segmental and calf bioimpedance spectroscopy~     (cBIS) techniques to measure body hydration. The device we used based on the FDA-approved~     Hydra 4200 (Xitron Technologies, San Diego, CA). The Hydra 4200 was initially developed to~     measure whole body and segmental body fluid volumes but Hydra is approved only for measuring~     healthy subjects. The cBIS monitors hydration state by continuously measuring change in~     resistance and resistivity in the calf during hemodialysis (HD) or it can be used for simple~     measurement before, during and after dialysis. Preliminary results in clinical studies have~     shown that optimal hydration state of HD patients may be determined by the calf method. This~     study aims to compare the Hydra 4200 to two other devices: the FDA approved ZOE (100 kHz)~     Fluid Status Monitor (Noninvasive Medical Technologies, Inc, Las Vegas) and a modified~     version ZOE 5 kHz. The modified ZOE monitor (ZOE (5 kHz)) delivers frequency of 5 kHz and 0.8~     mA current instead of 100 kHz and 2 mA.~      The subjects of this study include a group of hemodialysis patients and a group of healthy~     controls. The healthy controls are used to identify a normal range within the healthy~     population for each method. Each hemodialysis patient will be studied twice in different~     hydration state. The study will not change the procedure of the patient's dialysis treatment.~     Since all devices are based on noninvasive bioimpedance technique, this study has minimal~     risk.~   "
133931|NCT01814241|"~     The purpose of this study is to attempt to understand how desensitization works in peanut~     allergic children who are undergoing oral immunotherapy (OIT) to peanut. We want to identify~     the early changes in the desensitization process the immune cells undergo to become~     desensitized to the peanut protein.~   "
133932|NCT01814228|"~     Cardioinhibitory neurocardiogenic syncope (CNS) or vasovagal syncope, is the most frequent~     aetiology of syncope in young people without apparent cardiac or neurological pathology. It~     is usually caused by inappropriately trigger-activated cardiac reflex which finally~     precipitates asystole, sinus bradycardia, or atrioventricular (AV) block [1]. Despite young~     patients affected by CNS have an excellent prognosis when electro-structural heart diseases~     are excluded [2], their quality of life may be seriously affected by recurrent episodes [2,~     3]. Cardiac pacing might help to control symptoms and therefore is considered in patients~     aged more than 40 years old with recurrent episodes and documented cardioinhibitory response~     [1, 4]. In young individuals, the role of cardiac pacing is dubious due to predicted frequent~     device substitutions and adverse ventricular remodeling over time. Recently, radiofrequency~     (RF) biatrial ablation of ganglionated plexi (GP) has showed promising results in the short~     and long-term treatment of reflex syncope, functional atrioventricular block, or sinus node~     dysfunction [5, 6]. Nonetheless, strong evidences are emerging about efficacy of~     transcatheter ablation limited to ganglionated plexi in the right atrium with the possibility~     to avoid side-effects related to left-sided procedures [6]~      Aim of study~      To evaluate in a large cohort of patients effectiveness and safety of gangliar transcatheter~     ablation in the right atrium to obtain atrial denervation and prevent CNS.~      Study population and methods~      Twenty consecutive patients affected by cardioinhibitory neurocardiogenic syncope will be~     enrolled in the study.~      Inclusion criteria:~        -  age between 18 and 60 years~        -  3 syncopal episodes at least of likely CNS in the previous 2 years~        -  marked cardioinhibitory response to HUT or documented asystolic pauses at internal loop~          recorder registration [7].~      Cardioinhibition will be considered as elicitation of asystolic pause (sinus arrest or AV~     block) ≥ 3 seconds associated to syncope or ≥ 6 seconds and related presyncope.~      Exclusion criteria:~        -  documented myocardial and/or valvular abnormalities on 2D echocardiogram (ejection~          fraction lower than 50%)~        -  documented tachyarrhythmias as possible causes of symptoms~        -  channelopathies (Brugada syndrome, LQT or SQT syndrome)~        -  ventricular preexcitation~        -  symptomatic orthostatic hypotension diagnosed by standing blood pressure measurement~        -  pregnancy in women~        -  previous cardiac pacemaker implantation.~      After obtaining informed consent patients will undergo to basal electrophysiological study~     (EPS) to record AH interval, HV interval, Wenckebach cycle length, sinus node recovery time~     (SNRT) and correct sinus node recovery time (cSNRT); the same parameters will be recorded~     immediately after ablation. Following basal EPS an accurate (200 valid points at least)~     electroanatomic right atrium mapping (CARTO 3™ Biosense Webster, Inc) will be performed and~     subsequently radiofrequency delivered at right atrial anatomic sites where the underlying~     presence of ganglionated plexi (GPs) clusters was regarded as highly probable, on the basis~     of anatomical studies [8-11]: the supero-posterior area (superior right atrial GP, adjacent~     to the junction of the superior vena cava and the posterior surface of RA), the~     middleposterior area (posterior right atrial GP, posterior surface of the RA adjacent the~     interatrial groove), the infero-posterior area (inferior right GP placed between the inferior~     vena cava, coronary sinus ostium, and near the atrioventricular groove). Transcatheter~     ablation will be performed using an 8mm-tip catheter (Biosence-Webster Navistar DS 8mm) or an~     irrigated 4 mm-tip catheter with force control system (Biosence Webster Smarttouch). Ablation~     will be performed until complete elimination of local atrial electrical activity. Response to~     radiofrequencies delivery will be considered successful in case of asystolic pause or cardiac~     cycle lengthening of 30% (compared to basal cycle) at least. To prolong RF delivery despite~     asystolic response, a quadripolar catheter will be positioned in right ventricle to backup~     stimulation. To avoid phrenic nerve injury, high amplitude stimulation will be performed just~     before radiofrequency delivery to the superior right atrial GP.~      HRV analysis will be performed on admission, at 2 hour after ablation and patients discharge.~     The HRV analysis will include the following parameters: mean, maximal and minimal heart rate,~     SDNN (standard deviation of Normal-Normal), RMSSD (root mean square successive difference),~     pNN50 (percentage of differences between adjacent N-N intervals that are >50 msec), LF (low~     frequency), HF (high frequency).~      Moreover, an HUT and an HRV analysis will be performed at 1, 3, 6 and 12 months after~     ablation procedure during the follow up.~   "
133933|NCT01814215|"~     The purpose of this project is to evaluate the efficacy of a 9-month Family Child Care Home~     (FCCH)-based intervention, Keys to Healthy Family Child Care Homes, to increase the physical~     activity and improve the diet quality of children (1.5 to 4.9 years).~   "
133934|NCT01814202|"~     The purpose of this study is to determine whether a medical nutrition product, PTM202, along~     with standard of care, enhances recovery and reduces diarrhea morbidity in young children~   "
133935|NCT01814189|"~     The purpose of this study is to show the efficacy of promethazine in management of patients~     with moderate to severe migraine~   "
133936|NCT01814176|"~     During Anesthesia many patients require that a breathing be inserted into their windpipe.~     This is usually achieved using a direct laryngoscope, consisting of a retraction blade with a~     light near its end. When achieving a direct line-of-sight to the windpipe is difficult, more~     force is often applied, resulting in greater patient stress. A GlideScope video laryngoscope~     uses a camera and light source to see the windpipe. This enables the user to see objects that~     may not be in the direct line-of-sight. This likely results in less force being required,~     reducing patient stress. Because such stresses are often confounded by patient variables, we~     are comparing the forces required by the direct and video laryngoscopes on patients with at~     least one risk factor for difficulty, by directly measuring these with special sensors~     attached to the laryngoscope blades.~   "
133937|NCT01814163|"~     This is a pharmacogenomic study with carboplatin, paclitaxel and bevacizumab as first line~     therapy in patients with non-squamous advanced non-small cell lung cancer.~   "
133938|NCT01814150|"~     Docetaxel based chemotherapy is a standard therapy in various metastatic cancers including~     lung cancer, breast cancer, gastric cancer, prostate cancer, and bladder cancer.~      One of the main plasma protein carriers of docetaxel is Alpha 1 acid glycoprotein.~      Retrospective data suggests that plasma level of alpha 1 acid glycoprotein is associated with~     the outcome of docetaxel based therapy in cancer patients.~      The investigators aim to prospectively study the association between the plasma level of~     alpha 1 acid glycoprotein and the outcome of docetaxel based therapy in cancer patients.~   "
133939|NCT01814137|"~     This trial is conducted globally. The aim of the trial is to compare efficacy of insulin~     degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD)~     versus basal bolus with insulin degludec (IDeg) OD + IAsp three times a day (TID) in~     controlling glycaemia by evaluating glycosylated haemoglobin (HbA1c). The trial is an~     extension to trial NN5401-3941 (NCT01680341).~   "
133940|NCT01814124|"~     Femoroacetabular impingement (FAI) is recognized as a formal source of hip pain and~     disability typically affecting the young adult, active population and has been identified as~     a precursor to hip osteoarthritis (OA). Common impairments include sharp, anterior groin pain~     in a position of hip flexion limiting patients' ability to tolerate prolonged sitting,~     squatting, stair climbing, etc. resulting in both work limitations and decreased social~     participation. Manual therapy and exercise is known to be effective in reducing pain and~     increasing physical function in the management of hip OA. To the extent that FAI is often a~     precursor to developing hip OA, logic would seem to dictate a manual therapy plus exercise~     approach to decrease pain and disability and potentially prevent or delay osteoarthritis~     related surgery. Currently, surgery is considered the first line of treatment with respect to~     FAI. However, there is a lack of evidence to support or refute the use of conservative~     treatment interventions in this patient population.~      This study is designed to investigate the benefits of physical therapy interventions (manual~     therapy and exercise) over usual care for improving pain and physical function in patients~     with FAI of the hip. For this study, 52 participants will be recruited from the Department of~     Orthopaedic Surgery, Wake Forest Baptist Medical Center, for an outpatient consultation for~     consideration of hip arthroscopy surgery. Participants will include those patients who meet~     clinical and radiological criteria for formal diagnosis of FAI. Participants will be~     randomized into two treatment groups. Participants in one group will receive usual care plus~     manual therapy directed at the hip as well as a supervised exercise program and home exercise~     program twice weekly for six weeks. Participants in the usual care group will receive usual~     care as prescribed by the physician. Changes in pain, physical function and benefits of the~     intervention will be assessed over six weeks. Should this research study demonstrate~     treatment effectiveness of physical therapy intervention in patients diagnosed with FAI of~     the hip, manual therapy plus exercise may have the potential to delay or prevent surgery in~     this patient population. Further, to the extent to which FAI has been shown to lead to later~     development of hip OA, effective treatment interventions may help to delay or prevent~     secondary osteoarthritis related changes as well as total joint replacement surgery~     associated with hip OA. This study will provide preliminary data that can be used to prepare~     further grant applications designed to determine the safest, most effective treatments for~     patients with FAI.~   "
133941|NCT01814111|"~     The purpose of this study is to demonstrate whether renal sympathetic denervation is safe and~     effective in patients with hypertension and paroxysmal atrial fibrillation.~   "
133942|NCT01814098|"~     The purpose of this study is to evaluate the efficacy and safety of long term escitalopram~     treatment in participants with Major Depressive Disorder (MDD) with associated anxiety~     symptoms.~   "
133943|NCT01814085|"~     The purpose of this study is to evaluate the efficacy and safety of escitalopram treatment in~     participants with severe major depressive disorder (MDD [marked depression appearing in the~     involution period and characterized by hallucinations, delusions, paranoia, and agitation]).~   "
133944|NCT01814072|"~     The overall objective of the proposed research is to use an innovative methodological~     framework, the Multiphase Optimization Strategy (MOST), to design, for the first time, an~     optimized, scalable version of a technology-supported intensive lifestyle intervention (INLI)~     for obesity. MOST involves highly efficient randomized experimentation to assess the effects~     of individual treatment components, and thereby identify which components and component~     levels make important contributions to the overall program effect on weight loss. This~     information then guides assembly of an optimized treatment package that achieves target~     outcomes with least resource consumption and participant burden. Because the intervention~     strategies being tested minimize in-person coaching and leverage technology that participants~     already own, the new optimized intervention, to be called Opt-IN, will be more scalable than~     traditional INLIs. Opt-IN will thus enjoy greatly increased reach, and enable significant~     progress in the fight against obesity.~   "
133945|NCT01814059|"~     Background:~        -  Eosinophil-associated gastrointestinal disorders (EGID) are a group of related disorders~          that affect the esophagus, stomach, and bowel. There are two major types of EGID,~          eosinophilic esophagitis and eosinophilic gastroenteritis. They are caused by the body's~          immune system being activated by food allergens, which then damages the gut wall. People~          with EGID have large numbers of eosinophils (a type of white blood cell) in their gut.~          EGID can cause difficulty swallowing, abdominal pain, or nausea.~        -  At present, there are no drugs specifically approved to treat EGID. Most adults who have~          EGID receive steroid therapy to manage the symptoms. However, long-term steroid use may~          cause other problems in the body. Researchers want to see if low-dose sirolimus can be~          used to treat EGID. Sirolimus is a drug used to prevent rejection of transplanted~          organs. It may be able to keep the body's immune cells from being activated by food~          allergens and decrease the eosinophils.~      Objectives:~      - To see if low dose sirolimus is safe and decreases blood or gut eosinophils in EGID.~      Eligibility:~        -  Individuals between 18 to 65 years of age who have EGID.~        -  Participants must also have an elevated blood eosinophil count and positive blood tests~          for IgE antibodies to foods.~      Design:~        -  Participants who are on medicine for EGID or related symptoms must be on a stable dose~          for 1 month before screening and stay on that dose throughout the study.~        -  Participants will be screened with a medical history and physical exam, and review their~          symptoms. They will provide blood and urine samples. They will also have heart and lung~          function tests. Some participants may have allergy skin tests.~        -  At the first study visit, participants will have 2 days of inpatient tests. They will~          repeat the tests from the screening visit. They will also have a full analysis of the~          esophagus, stomach, and small intestine. On the second day, they will start to take~          sirolimus as a liquid with orange juice or water.~        -  Participants will continue to take sirolimus at home. They will record their doses and~          any symptoms. They will also have a visit to provide blood samples about 2 weeks after~          the first study visit.~        -  At the second study visit (about a month after the first visit), participants will~          repeat the tests from the screening visit. The sirolimus dose may be adjusted as needed.~        -  Participants will take sirolimus for at least another 28 days. Depending on the dose of~          the drug and the blood test results, some participants may need to take it for up to 112~          days. Those who take the drug for a longer period will have additional study visits with~          tests.~        -  There will be another study visit when participants stop taking the drug. The last visit~          will be a final follow-up visit.~   "
133946|NCT01814046|"~     Background:~      - The National Cancer Institute (NCI) Surgery Branch has developed an experimental therapy~     that involves taking white blood cells from patients' tumors, growing them in the laboratory~     in large numbers, and then giving the cells back to the patient. These cells are called Tumor~     Infiltrating Lymphocytes, or TIL and we have given this type of treatment to over 200~     patients with melanoma. This study will use chemotherapy to prepare the immune system before~     this white blood cell treatment. After receiving the cells, the drug aldesleukin (IL-2) may~     be given to help the cells stay alive longer.~      Objectives:~      - To see if chemotherapy and white blood cell therapy is a safe and effective treatment for~     advanced ocular melanoma.~      Eligibility:~      - Individuals at least greater than or equal to 16 years to less than or equal to 75 years~     who have advanced ocular melanoma.~      Design:~        -  Work up stage: Patients will be seen as an outpatient at the National Institutes of~          Health (NIH) clinical Center and undergo a history and physical examination, scans,~          x-rays, lab tests, and other tests as needed.~        -  Surgery: If the patients meet all of the requirements for the study they will undergo~          surgery to remove a tumor that can be used to grow the TIL product.~        -  Leukapheresis: Patients may undergo leukapheresis to obtain additional white blood~          cells. {Leukapheresis is a common procedure, which removes only the white blood cells~          from the patient.}~        -  Treatment: Once their cells have grown, the patients will be admitted to the hospital~          for the conditioning chemotherapy, the TIL cells and aldesleukin. They will stay in the~          hospital for about 4 weeks for the treatment.~        -  Follow up: Patients will return to the clinic for a physical exam, review of side~          effects, lab tests, and scans about every 1-3 months for the first year, and then every~          6 months to 1 year as long as their tumors are shrinking. Follow up visits take up to 2~          days.~   "
133947|NCT01814033|"~     The Null Hypothesis is that there is no significant change in range of motion (ROM), pain, or~     function for a group of patients following total knee arthroplasty (TKA) who use the LRU~     pillow as compared to a control group of total knee arthroplasty patients who do not use the~     pillow.~   "
133948|NCT01814020|"~     Assess efficacy and safety of topical MOB015B, applied daily during 48 weeks, in adults with~     fungal nail infection.~   "
133949|NCT01814007|"~     To evaluate if multiple same-day CoolSculpting treatments increase the risk of abnormal~     lipids and liver-related tests.~   "
133950|NCT01813994|"~     Statins are commonly used as cholesterol-lowering medications and have shown effectiveness in~     the primary and secondary prevention of heart attack and stroke. In addition, several recent~     studies of human cancer cell lines and animal tumor models indicate that statins may have~     chemopreventive properties through the arresting of cell-cycle progression. The~     chemopreventive effect of statins was demonstrated in some kind of human tumors including~     colorectal cancer. In addition, recent one large epidemiologic study showed that statins~     decreased risk of gastric cancer. On the other hands, it has been well known that~     Helicobacter pylori infection induces gastric atrophy and intestinal metaplasia, which are~     premalignant lesions of gastric cancer. Progression of these premalignant lesions could be~     limited by H. pylori eradication. In addition, a recent double blind randomization study~     revealed that simvastatin as adjuvant to standard therapy improves significantly the H.~     pylori eradication rate. Therefore, investigators conjecture that statins may have an~     adjuvant role for inhibition of gastric carcinogenesis. investigators aim to evaluate the~     role of statins in gastric carcinogenesis by observing the changes of gastric inflammation~     under statins.~   "
133951|NCT01813981|"~     Evidence suggests that a diet rich in plant phenolic compounds may induce beneficial vascular~     effects. Coffee is a good source of phenolic compounds called chlorogenic acids (CGA),~     however the level of CGA is reduced during the roasting process.~      The aim of this study is to investigate the effect of coffee roasting on vascular response.~     The investigators hypothesize that coffee roasted to a lesser extent will exert a favourable~     vascular response over more heavily roasted coffee due to the higher levels of CGA.~   "
133952|NCT01813968|"~     Ischemic postconditioning by repetitive cycles of reperfusion and ischemia has been proven~     both in animal models and in humans. This study aims to investigate the effect of ischemic~     postconditioning on postoperative hemodynamic function in a standard heart surgery patient~     population.~   "
134090|NCT01812161|"~     Low-frequency electroacupuncture (EA) can decrease serum 17-hydroxyprogesterone (17-OHP),~     androstenedione (A) and testosterone (T)of young women with polycystic ovary syndrome in the~     Human chorionic gonadotrophin (HCG) stimulation test ，also，we hypothesize that EA is more~     efficiency in improving ovulation rate and menstrual cycle than sham acupuncture.~   "
133953|NCT01813955|"~     Phosphodiesterase (PDE) inhibitors represent a new group of potential antipsychotic compounds~     currently under development. One of these is papaverine, an inhibitor of the PDE 10 family.~     The class of PDE10 inhibitors have been reported as possible candidates in the treatment of~     schizophrenia, and may prove an attractive antipsychotic alternative due to the many~     side-effects of the currently available antipsychotics. It has been proposed from preclinical~     studies that PDE10 inhibitors have the potential to reduce cognitive deficits in~     schizophrenia and these findings need to be confirmed in a human population, in view of the~     fact that no other currently registered drug posses these unique properties.~      The currently proposed project is designed to investigate whether the PDE10 inhibitor~     Papaverine indeed have the capacity to reduce cognitive deficits in schizophrenia patients.~     In order to accomplish this effect, Papaverine will be investigated in schizophrenia, with~     regards to symptomatology, hemodynamic, neurocognition and early information-processing.~   "
133954|NCT01813942|"~     In order to perform research smoothly, the process of information extraction is required for~     translating data in clinical text into available format for analysis and statistic. In~     medical research, the problem of missing data occurs frequently. It is important to develop~     the method with better imputation performance in the stability and accuracy. The purposes of~     this project are to provide the data integration and extraction methods for handling the~     structured and unstructured data sources in more efficient ways, to provide the validation~     scheme for facilitating the data reviewing of extracted results produced by information~     extraction modules, to increase the quality of clinical data by comparing the data from~     different data sources and correcting data errors and inconsistent, to handle the clinical~     data with the properties of time series and incompleteness, to increase accuracy of data~     analysis and increase quality of health care by improving the completeness and correctness of~     clinical data, to provide flexibility of methods in the platform. In the project, the disease~     topic is focused on the liver cancer patients' clinical data and we hope the methods in the~     projects can be extended to handle other diseases by replacing these knowledge models in the~     future.~   "
133955|NCT01813929|"~     Insulin resistance (IR) is an important contributor to increased cardiovascular disease risk~     in type 1 diabetes (T1D). The purpose of this study is to measure the effect of metformin on~     insulin sensitivity, vascular function and compliance, and mitochondrial function in T1D. The~     long term goal is to identify novel non-glycemic approaches to managing cardiovascular~     disease risk in T1D. The results of this study may validate a novel approach to T1D treatment~     that could significantly improve current management of cardiovascular disease risk in this~     high risk population.~   "
133956|NCT01813916|"~     The purpose of this study is to use the proteomic analysis of synovial fluid to perform the~     comprehensive investigation of the biomarker that will be useful to assign the tratment~     effectiveness of five weekly intra-articular HA injection.~   "
133957|NCT01813903|"~     The purpose of this study was to test internet and mobile-based applications to support~     motivating lifestyle counseling to promote healthy eating habits of the mothers and their~     spouses expecting first child. The feasibility of the intervention will be evaluated in the~     pilot.~   "
133958|NCT01813890|"~     The purpose of this study is to evaluate the analgesic efficacy and safety of tapentadol~     immediate-release (IR [CG5503]) for use in the relief of moderate to severe acute pain,~     compared with placebo, in adult Taiwanese patients with acute pain following bunionectomy.~   "
133959|NCT01813877|"~     It was previously shown that 18F-DOPA PET imaging results in intended management changes in~     41% of brain tumor patients. However, its impact on patient outcome defined as survival,~     costs, and/or quality of life has not been demonstrated. Regulatory agencies require~     randomized trials to determine the impact of PET on patient management and outcome. In this~     study we hypothesize that the addition of 18F-DOPA PET will improve patient outcome by more~     accurately identifying presence or absence of tumor recurrence than conventional imaging.~   "
133960|NCT01813864|"~     The proposed Quality Improvement Initiative study is a health services research project in~     community-based substance abuse treatment programs. The primary goals are to use training and~     technology transfer to match services to client needs, increase the number of services~     received by clients, and improve client outcomes. This is a two phase study in which we~     compare clients pre-intervention to clients post-intervention.~      Clients from Phase II (Post-Intervention) compared to Phase I (Pre-Intervention) will:have~     treatment plans that better match the problems reported at assessment; receive services that~     better match their needs, as reported during the assessment/intake; show better results~     during treatment performance on the Treatment Services Review (TSR), including attending a~     greater percentage of their scheduled treatment sessions and increased satisfaction with the~     Treatment Planning process; show better client outcomes at 3 month follow-up on primary drug~     and alcohol measures, including Breathalyzer and urine drug screen, and secondary personal~     health and social functioning measures such as days medical problems, days psychiatric~     problems, days employed, days of conflict with family members, etc.~   "
133961|NCT01813851|"~     Sedentary behavior and protein-energy wasting (PEW) are well known risk factors of adverse~     outcome and low quality of life in chronic renal failure patients treated by dialysis.~     Treatment strategies of PEW by different types of nutritional support (as dietary counseling,~     oral nutritional supplements or intradialytic parenteral nutrition) have limited efficacy.~     Physical activity has been shown to have numerous positive impacts in pathologic conditions~     associated to end stage renal disease.~      Concomitant prescription of physical activity and nutritional support might mutually enhance~     the anabolic effects of these interventions and improve the rate of remission of PEW.~      The aim of this study is to analyze the effect of a programmed, progressive endurance~     training performed during the dialysis session on a cycle ergometer under the supervision of~     a qualified trainer, on protein energy wasting and physical functioning of chronic~     hemodialysis patients.~   "
134019|NCT01813097|"~     Patients with prostate cancer should have the following examination including biopsy, serum~     PSA volume, prostate CT scan or MRI, bone scan, abdomen ultrasound, chest X ray, blood~     biochemistry, blood rout, ECG and testosterone.~      Two groups:~      First group:30 cases should be treated with iodine 125 seed implants 0.5 mc transperineal~     prostate implant +Zoladex 3.6mg im 1/28d (LHRH agonist, 3.6mg subcutaneous injection~     1/4weeks).~      Second group: 30 cases should be treated with Zoladex 3.6mg im 1/28d (LHRH agonist, 3.6mg~     subcutaneous injection 1/4weeks).~      PFS and PSA level will be the primary variables.~   "
133962|NCT01813838|"~     A phase I-II trial of Acadesine in IPSS high and int 2 myelodysplastic syndromes, acute~     myeloid leukemia with 20-30% marrow blasts and chronic myelomonocytic leukemia type 2 not~     responding to Azacitidine or Decitabine for at least 6 courses or relapsing after a response:~      Patients will receive 6 treatment cycles unless disease progression, transformation, or~     unacceptable toxicity occurs, or the patient refuses to continue participating in the study.~      Efficacy will be assessed at the end of the 2nd, 4th and 6th cycles. After 6 cycles, patients~     demonstrating a response (CR, PR, marrow CR, or HI) will be able to continue with cycles of~     Acadesine (at the same dose as in the preceding cycles, depending on their cohort) until~     progression.~   "
133963|NCT01813825|"~     A registry is an observation database. Participation in this registry does not require any~     additional or different procedures or drugs other than those you would normally receive for~     breast cancer. Registry databases are used to identify trends in medical care that help the~     medical community identify optimal care for different diseases.~      The data will be compiled on the safety and performance of the Partial Breast Brachytherapy~     Applicator based on the information collected about the treatment and follow up visits.~   "
133964|NCT01813812|"~     This is a multicenter, double-blinded, double-dummy, active-controlled, randomized, Phase III~     clinical trial to evaluate the efficacy and safety of DA-6034 and to demonstrate the~     non-inferiority of DA-6034 compared with Rebamipide in patients with acute or chronic~     gastritis. Subjects will receive 45mg, 90mg of DA-6034 and 300mg of Rebamipide, two tablets,~     three times a day for two weeks.~   "
133965|NCT01813799|"~     This is a Phase II dose-ranging study to evaluate the effectiveness and safety of DA-9801 in~     the treatment of pain associated with diabetic neuropathy. Subjects will receive either~     300mg, 600mg, 900mg or placebo, three times daily for eight weeks. During treatment, pain~     score by Likert numerical rating scale, Patient Global Impression of Improvement (PGI-I) and~     Change in Clinical Global Impression(CGI)are accessed to evaluate the effectiveness.~   "
133966|NCT01813786|"~     Compare efficacy and safety of handpieces on the 755nm Alexandrite laser for the treatment of~     scars.~   "
133967|NCT01813773|"~     To assess the safety of intravitreal aflibercept injection in the treatment of proliferative~     diabetic retinopathy (PDR) by evaluating the incidence and severity of adverse events.~   "
133968|NCT01813760|"~     The Diode laser system is being used in this marketing study for the treatment of wrinkles~     around the eyes and mouth.~   "
133969|NCT01813747|"~     The purpose of this study is to use the 1440nm Wavelength laser along with the hand piece to~     provide clinical outcome data for treatment of the mandibular and submandibular areas~     specifically for skin tightening and laser lipolysis.~   "
133970|NCT01813734|"~     This research study is a Phase II clinical trial, which tests the safety and effectiveness of~     an investigational drug to learn whether the drug works in treating a specific cancer.~     Investigational means that the drug is being studied.~      It has been found that some people with NSCLC have a change (mutation) in a certain gene~     called the RET gene. This mutated gene may help cancer cells grow. Only participants with a~     RET mutation will be allowed to participate. In this study, investigators are testing the~     strategy of using a study drug designed to inhibit or shut off growth signals that results~     from the mutated RET gene.~      Ponatinib is an anti-cancer drug that has been used in research studies for other types of~     cancer. Ponatinib blocks several growth signals in cancer cells, including RET. In this~     research study, investigators are looking to see whether ponatinib is effective and safe in~     treating NSCLC harboring RET rearrangements.~   "
133971|NCT01813721|"~     This is a prospective observational study investigating how physicians assess the risk of~     febrile neutropenia (FN) developing in patients who will receive chemotherapy.~      Approximately 150-200 investigators will take part in about 100 sites in Europe, Canada and~     Australia. Approximately 1000 subjects will be studied, all of whom will have non-small cell~     lung cancer (NSCLC), small cell lung cancer (SCLC), non-Hodgkin's lymphoma (NHL) or breast~     cancer and will be due to receive one of the specific chemotherapy regimens of interest.~      Investigators' approach to FN risk assessment will be studied using lists of possible risk~     factors they may consider during their assessment. Investigators will be asked to select and~     rank the factors they consider the most important when assessing the overall FN risk of a~     subject and when making the decision whether to treat with granulocyte-colony stimulating~     factor (G-CSF) primary prophylaxis (PP). They will be asked to make these selections based~     initially on their own routine clinical practise and subsequently relating specifically to~     each subject recruited.~      This is a non-interventional study that involves no procedures outside normal care for the~     subjects; all data collection will be completed prior to chemotherapy administration.~   "
133972|NCT01813708|"~     200 type 2 diabetes patients will be randomly submitted to an intensive life-style or a~     collaborative educational programmes by means of random numbers list. The intervention will~     be conducted by certified nutritionists or certified diabetes educators, previously trained~     in behavioural modification and in self-care techniques. The intervention will last 16 weekly~     sessions and A1c, LDL cholesterol, blood pressure will be measured as main variables.~     Furthermore, body weight and abdominal girth, other lipids (HDL cholesterol,~     triglycerides),and physical activity, quality of life, psychological well-being and~     self-efficacy will be measured with specific questionnaires for up to 6 months.~   "
133973|NCT01813695|"~     The purpose of this study is to see if testing for genes related to pain and pain management~     before surgery affects how patients are treated for pain after surgery. The investigators~     want to know if this information will be used to effectively treat patients for pain after~     surgery if the clinical staff have a chance to review it before the surgery.~   "
134020|NCT01813084|"~     RV1729 is a new medicine being developed for possible treatment of asthma and smoking related~     lung disease (also known as chronic obstructive pulmonary disease - COPD).~      The main purpose of this study is to investigate the safety, tolerability and~     pharmacokinetics of single and repeat doses of RV1729.~   "
134091|NCT01812148|"~     Review of the investigators hospital experience in cytoreductive surgery and hyperthermic~     intra-peritoneal chemotherapy (HIPEC) for peritoneal mesotheliomas, using Oxaliplatin as~     intraperitoneal chemotherapeutic agent.~   "
134092|NCT01812135|"~     A randomized, double-blind, phase II-02 clinical trial is to evaluate the safety and~     immunogenicity of an inactivated EV71 vaccine with or without aluminum adjuvant~   "
133974|NCT01813682|"~     The purpose of this study is to determine whether iron-fortified TPN is effective in the~     preventative and treatment of preterm infants. Preterm infants are at risk for anemia~     especially in preterm infants. Generally the smaller Birth weight and gestational age the~     higher anemia rate in infants. About 25% to 85% of preterm infants develop evidence of anemia~     during infancy，77% VLBW（very low birth weight） infants developed anemia during the hospital~     stay. The effects of iron deficiency are pervasive and involve multiple organ systems. Poor~     physical growth, gastrointestinal disturbances, thyroid dysfunction, altered immunity and~     temperature instability has been attributed to iron deficiency in very low birth weight~     infants. So it is important to provide iron for preterm infants.~      As enteral nutrition is not feasible soon after birth in most preterm infants, Parenteral~     iron administration is an efficacious method for us to select. For most preterm infants the~     use of TPN(total parenteral nutrition) is very common during the first ten days of life, so~     we hypothesis that iron-fortified TPN may have a preventative and treatment effect on preterm~     infants using TPN as a supplementation of oral nutrition; Iron-fortified TPN(total parenteral~     nutrition) can also improve iron store status of preterm infants. The higher concentration of~     iron used in this study the larger preventative or treatment effect on preterm infants~     anemia; It is safe to add Small dose of iron agent to TPN.~   "
133975|NCT01813669|"~     The purpose of this study is to examine whether an integrative group-based intervention will~     help children experiencing psychological and physical distress. Children, ages 10 to 12, will~     be recruited for participation in this therapeutic group. Eligible and consenting~     participants will be randomized to a wait-list control group or the group intervention. The~     group intervention will take place over a 12-week period, during which participants will~     attend a weekly coping skills group that integrates yoga-based practices (such as yoga poses,~     mindfulness, self-acceptance, breath work) with cognitive-behavioral principles (such as~     increasing awareness of thoughts and emotions).~   "
133976|NCT01813656|"~     Methamphetamine substance use is common worldwide. No approved pharmacologic treatments for~     methamphetamine dependence exist. Aripiprazole are Second generation antipsychotics，but have~     different pharmacological effects of neurotransmitters.To determine whether mirtazapine would~     reduce methamphetamine use among mehtamphetamine addicts.~   "
133977|NCT01813643|"~     Methamphetamine-associated psychosis (MAP) has been considered a pharmacological or~     environmental pathogen model of schizophrenia (SCZ) due in part to similarities in clinical~     presentation (i.e. paranoia, hallucinations, disorganized speech, and negative symptoms),~     response to treatment (e.g.neuroleptics),and pathologic mechanisms (e.g. central dopaminergic~     neurotransmission) of both conditions. Both risperidone and aripiprazole are second~     generation antipsychotics，but have different pharmacological effects of antipsychotic~     treatment.This study was designed to examine the acute efficacy, safety, and tolerability of~     risperidone and aripiprazole for patients with MAP.~   "
133978|NCT01813630|"~     A study demonstrates the non-inferiority of DA-3002 when compared with Genotropin®.~   "
133979|NCT01813617|"~     Most patients respond to medical treatment with corticosteroids and immunosuppressive~     treatment, but a majority of patients develop sustained muscle impairment. The aim of this~     study was to evaluate the outcome of muscle endurance assessed with the Functional Index-2~     (FI-2), muscle strength assessed by the MMT-8 and disease activity assessed by the six item~     core set at 6 and 12 months following diagnosis in patients with polymyositis (PM) and~     dermatomyositis (DM).~      72 patients diagnosed with probable or definite PM or DM 2003-2010 who performed the FI-2 and~     the MMT at the time of diagnosis were included in this Swedish Myositis Register study. All~     patients had performed both the Functional Index-2 assessing muscle endurance and the Manual~     Muscle test (MMT) assessing isometric muscle strength. Physician Global assessment based on~     the evaluation of the consensus recommended six item core set for disease activity assessment~     was also included. Data were analysed on group levels as well as with criteria for individual~     responder criteria. A responder was identified as improving at least 20 % compared to~     baseline.~   "
133980|NCT01813604|"~     This study is an open-label phase III randomized clinical trial that would compare~     immunogenicity after receiving one of five different combinations of polio vaccines. Infants~     will be enrolled and randomized at 6 weeks of age to one of five different arms:~      A) Three doses of trivalent oral poliovirus vaccine (tOPV) at 6, 10 and 14 weeks of age B)~     Three doses of bivalent OPV (bOPV) at 6, 10 and 14 weeks of age C) Two doses of intramuscular~     (IM) inactivated poliovirus vaccine (IPV) at 6 and 14 weeks of age D) Two doses of~     intra-dermal (ID) fractional IPV (f-IPV) at 6 and 14 weeks of age E) Sequential~     administration of ID f-IPV at 6 and 14 weeks of age with bOPV at 10 weeks of age To assess~     the immunogenicity of each study vaccine and vaccination schedule, antibody titers against~     poliovirus types 1, 2 and 3 will be determined in sera extracted from blood collected before~     (at 6 weeks of age) and after receiving 3 doses of study vaccine (18 weeks of age).~     Seroconversion will be defined as a titer 4-fold higher than the expected fall in maternally~     derived antibodies, assuming a half-life of 28 days. The initial antibody titer at 6 weeks of~     age will be used as the starting point for the expected decline in maternal antibody.~      This study will compare the immunogenicity of:~        1. Sequential dose of intra-dermal f-IPV and bOPV to bOPV alone administered at 6, 10 and~          14 weeks of age~        2. tOPV to bOPV administered at 6,10 and 14 weeks of age~        3. IM IPV to ID f-IPV administered at 6 and 14 weeks of age The answer to these questions~          will guide the global polio eradication program in designing new routine immunization~          schedule for children that eliminates the risks of paralysis due to vaccine derived~          poliovirus (VDPV) from type 2 vaccine poliovirus.~   "
134029|NCT01812967|"~     The investigators hypothesize that the physiological effects of milk on satiety and glycemic~     control are mediated by the interaction between its macronutrient components by both~     insulin-dependent and independent mechanisms.~   "
134093|NCT01812122|"~     The purpose of this study is to analyze the differences of blood sugar level and glycemic~     variability between sulfonylurea and DPP-4 inhibitor groups applying CGMS for a chosen number~     of type 2 DM patients. The investigators also reveal influences of each drugs on~     cardiovascular risk factors by measuring related biomarkers.~   "
134094|NCT01812109|"~     Testicular torsion is the spontaneous twisting of the testis and its blood vessels, resulting~     in acute pain, vascular compromise and death of the testicle if unrelieved quickly. In this~     study, investigators will test a near-infrared spectroscopy (NIRS) device that rapidly and~     non-invasively measures deep tissue oxygen saturation.~   "
133981|NCT01813591|"~     This small study is to investigate the efficacy of Acthar in the treatment of chronic~     migraine in patients who have failed multiple treatments, including Botox (which is defined~     as having <30% reduction from baseline in the number of headache days per month). Despite the~     widespread use of anti-seizure medications, there remain a significant number of patient~     whose migraines are refractory to these agents. The pathophysiology of migraine is such that~     the neural substances calcitonin G related protein (CGRP), substance P, and neurokinin A are~     released at the trigeminal nerve endings innervating the large cranial and dura mater blood~     vessels and this neurotrasmission generates migraine associated pain. Because of this,~     treatment for migraine can be directed towards down regulating those receptor sites~     accordingly. Acthar may provide pain relief through this mechanist, as ACTH has been shown to~     inhibit the release of CGRP and may also provide relief through a negative feedback loop as~     exogenous ACTH inhibits CRH release and mast cell degranulation.~   "
133982|NCT01813578|"~     The hypothesis is that intensive aerobic and endurance muscle training is safe and beneficial~     in patients with systemic sclerosis and concurrent interstitial lung disease.~      The purpose of the study is to examine the effect of an eight week intensive aerobic exercise~     and muscle endurance training program for patients with systemic sclerosis and 50-100 % of~     forced vital capacity.~      A single subject experimental design with repeated systematic measures during a six week~     A-phase (baseline period) and an eight week B-phase (intervention period) was used. Physical~     capacity (six minute walk test), aerobic capacity (submaximal treadmill test) and muscle~     endurance in shoulder and hip flexion (Functional Index 2) are assessed every other week~     throughout the 14 week study. Activity limitation (Health Assessment Questionnaire), quality~     of life (Short Form 36), Raynaud, Fatigue and Global Health during the recent week (Visual~     Analogue Scales) are assessed at weeks 0, 6, 14. The exercise program includes aerobic~     exercise corresponding to 15 on the Borg RPE scale (strenuous) and muscular endurance~     training three times/week.~   "
133983|NCT01813565|"~     The purpose of this study is to evaluate efficacy and safety of additional hyaluronic~     acid/chondroitin sulfate to transurethral resection of bladder ulcer in patient with~     interstitial cystitis.~   "
133984|NCT01813552|"~     This study is designed to evaluate the potential for an effect of Ritonavir (Norvir®) or~     omeprazole (Prilosec®) on the pharmacokinetics of samatasvir and to assess the safety and~     tolerability of the study drugs when administered alone and in combination in healthy~     participants.~   "
133985|NCT01813539|"~     The purpose of this study is to determine the recommended Phase 2 dose of ARGX-110, an~     antibody that binds CD70, in patients with advanced malignancies.~   "
133986|NCT01813526|"~     Infants with protein sensitive colitis fed a nutritionally complete free amino acid-based~     medical food will be evaluated for 42 days.~   "
133987|NCT01813513|"~     The purpose of this 3-part study is to evaluate the potential impact of simeprevir and food~     on pharmacokinetics (PK) of IDX719 in healthy participants. Part 1 will evaluate potential PK~     interactions between IDX719 and simeprevir. Part 2 will evaluate the effect of food on the PK~     of IDX719 in combination with simeprevir. Part 3 will evaluate the impact of high- versus~     low-fat meals on the PK of IDX719.~   "
133988|NCT01813500|"~     The inflammatory bowel diseases (IBD), ulcerative colitis (UC) and Crohn's disease (CD) are~     chronic conditions affecting approximately 1.4 million Americans. The burden of Clostridium~     difficile infection (CDI), a frequent cause of infectious diarrhea is mediated by toxins A~     and B and is increasing faster in IBD patients, than the general population. Clinically, CDI~     in patients with IBD leads to a range of clinical syndromes from symptomless carriage, to~     severe life threatening colitis, colectomy and death.~      This pilot study will look at the relationship between IBD and this variable host immune~     response. Clostridium difficile colonization (asymptomatic carrier state) is lower in the IBD~     population than in the general population. In the general population, high antitoxin titers~     have been linked with colonization and low antitoxin titers with recurrent disease. The~     investigators hypothesize that patients with IBD will have a lower Clostridium difficile~     colonization and will have lower antibody titers than the control group. Additionally those~     with lower titers will have an increased risk of developing CDI.~      In Aim 1 the investigators will determine Clostridium colonization in IBD subjects by stool~     study (including CD, UC and UC patients after IPAA) compared to non-IBD subjects (controls).~     In Aim 2 the investigators will compare antitoxin titers in these IBD subjects compared to~     controls. In Aim 3 the investigators will follow these subjects for 12 months and calculate~     the incidence of CDI in patients with IBD compared to controls and associations with~     anti-toxin titers.~   "
133989|NCT01813487|"~     The purpose of this study is to examine the immunogenicity and efficacy of HBsAg Vaccine in~     combination with Entecavir in patients who have been treated with HB110E HBV DNA vaccine.~   "
133990|NCT01813474|"~     The objective of this study will be to investigate the safety and tolerability of olaparib~     tablet when given orally to Japanese patients with advanced solid malignancies. In addition,~     the pharmacokinetic profile, MTD (if possible) and efficacy of olaparib will be investigated.~   "
133991|NCT01813461|"~     The purpose of this study is to evaluate the pharmacokinetics of 14C-labeled isavuconazole~     and the routes of excretion and the extent of metabolism of 14C-labeled prodrug BAL8557.~   "
133992|NCT01813448|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK)~     of single and multiple ascending doses of fidaxomicin in healthy subjects. This study will~     also compare the safety, tolerability and PK of single and multiple doses of fidaxomicin in~     healthy Japanese and Caucasian subjects.~   "
133993|NCT01813435|"~     After a stent procedure, it is common practice to prescribe anti-platelet medication to~     prevent the blood from clotting. The main objective of this study is to determine if there is~     a better medication strategy to prevent blood from clotting and at the same time minimising~     the number of complications.~      There are two medication strategies:~        -  Study group: Dual anti-platelet therapy (ticagrelor combined with aspirin) for 1 month,~          and then ticagrelor alone for another 23 months OR~        -  Control group: Standard treatment, being dual anti-platelet therapy (ticagrelor or~          clopidogrel combined with aspirin) for 12 months, and then aspirin alone indefinitely~   "
133994|NCT01813422|"~     This study will evaluate whether low-density lipoprotein (LDL-C) lowering with evolocumab~     (AMG 145) results in greater change from baseline in percent atheroma volume (PAV) at week 78~     than placebo in adults with coronary artery disease taking lipid lowering therapy.~   "
133996|NCT01813396|"~     First, the purpose of the first year study will examine the joint capsule/muscular and~     shoulder physical activity hypotheses related to ROM deficits as well as functional~     disability in subjects with Stiff shoulders. Second, the purpose of the second and third year~     study will investigate the long-term effect of 12-week joint mobilization, 12-week joint~     mobilization plus soft tissue mobilization/massage, and 12-week joint mobilization plus soft~     tissue mobilization/massage with appropriate shoulder physical activity guide on subjects~     with Stiff shoulders. Subjects: First year: thirty subjects with Stiff shoulders will be~     recruited. Second and third years: forty-five subjects with Stiff shoulders for one year~     follow-up. Methods: For the measurement outcomes; functional disability, rotation range of~     motion, joint mobility, muscle stiffness, and shoulder physical activity will be measured by~     self-reported Flexi-level Scale of Shoulder Function or performance-based motion analysis,~     goniometer, uni-axis load cell and electromagnetic tracking sensor, myotonometer, and~     accelerometers, respectively.~   "
133997|NCT01813383|"~     Celiac disease patients with HLA-DR7-DQ2 haplotype have the same histological, analytical and~     clinical behaviour as patients with HLA-DR3-DQ2 haplotype.~   "
133998|NCT01813370|"~     The purpose of this study is to continue follow-up on patients who were treated on the study~     called TAX 3505 (MSK IRB #07-101). The sponsor of this study, has decided to end the study~     early, before all patients have completed all planned follow-up tests. As a result, the~     investigators do not yet know whether hormonal therapy alone, or in combination with~     docetaxel, is better at preventing prostate cancer recurrence in patients who had a rising~     PSA after prostatectomy. This study will continue following patients according to a schedule~     that is similar to that found in the TAX 3503 (MSK IRB #07-101) study in order to answer that~     question. This study is known as a registry study. The patients' will not receive any~     treatment as part of this study. Instead, they will be asked to have a blood test performed~     once every 12 weeks.~   "
133999|NCT01813357|"~     This study is a randomised double blind placebo controlled trial comparing Rosuvastatin with~     placbeo in HIV positive people who are at intermediate cardiovascular risk.~      It is possible that HIV positive people will receive a greater benefit from statins because~     of their higher baseline levels of inflammation. Current Australian guidelines recommend~     initiation of statin therapy on the basis of cholesterol level and the presence of other risk~     factors for heart disease (such as diabetes) but do not take into account whether a patient~     is infected with HIV. This study aims to determine what benefit HIV infected people will~     receive from starting statin therapy earlier then currently recommended.~   "
134000|NCT01813344|"~     Treatment outcomes of lymphoblastic lymphoma (LBL) have improved by the use of the regimens~     for acute lymphoblastic leukemia. Hyper-CVAD is one of the most effective treatments with~     high remission rate in acute lymphoblastic leukemia (ALL) and LBL. However, the treatment~     outcome of hyper-CVAD in LBL has reported only in small number of patients from single~     institution. The investigators conducted this study to evaluate the hyper-CVAD regimen based~     treatment in LBL.~   "
134001|NCT01813331|"~     ALERT-HF is an observational study aimed to evaluate the diagnostic criteria adopted and the~     adherence to the current therapeutic guidelines in a large series of patients affected with~     chronic heart failure. Secondary objective is to evaluate the prevalence of chronic heart~     failure among all the patients referring to the ambulatory cardiologists of the healthcare~     district.~   "
134002|NCT01813318|"~     Recent pharmacotherapy research in autism spectrum disorders (ASD) has successfully focused~     on treatment of co-occurring symptoms, including inattention, hyperactivity, and irritability~     that commonly occur in persons with ASD. Despite over two decades of significant~     pharmacotherapy research, to date no medication has been shown in controlled trials to~     enhance the core social deficits of ASD. Based upon findings describing the neurobiology of~     ASD combined with our preliminary results, we believe the novel drug acamprosate will show~     evidence of reducing social skills deficits associated with ASD.~   "
134003|NCT01813305|"~     The objective of this study is to evaluate the efficacy and safety of CSTC1 in patient with~     diabetic foot ulcers.~   "
134004|NCT01813292|"~     HIV+ patients are considered at risk for excessive bone fragility. Several factors could~     contribute: age, male sex, low body mass index (BMI), HIV infection per se, vitamin D~     deficiency, using tenofovir/a protease inhibitor (time on and/or current use). Tenofovir is~     used in a backbone of nucleosides/nucleotides analogues with emtricitabine (FTC), licensed as~     TRUVADA®, or without this analogue, licensed as VIREAD®. FTC closely resembles lamivudine~     (3TC) but is 5-fluorinated, the daily intake of fluoride is ~15 mg. Fluoride induces bone~     formation by stimulating osteoblasts, of often impaired bone quality.~      The aim of the study is to compare in a cross-sectional design fluoride levels, bone renewal,~     bone mineral density (BMD) in HIV+ male patients treated by TRUVADA® or VIREAD® for more than~     60 months. The patients will be randomly selected, then matched according to age, ethnic~     origin, BMI.~   "
134005|NCT01813279|"~     Systemic sclerosis is an autoimmune disease characterized by skin lesions and visceral~     responsible for significant morbidity. Microcirculatory disorders and tissue fibrosis are~     excessive severity of the disease. This condition can affect the hands with a major~     functional consequence severely impairing the quality of life of patients.~      Adipose tissue is used in plastic surgery for over a century for the filling of depressions~     in the skin. In addition to the volume effect, a trophic effect on the surrounding tissue was~     noted. It is shown that the stromal vascular fraction is responsible for this regenerative~     effect.~      In a previous study the investigators have demonstrated in a mouse model that the~     subcutaneous adipose tissue provides a trophic effect on SSc skin lesions by reducing the~     fibrosis of the dermis and providing a pro angiogenic.~      Objectives and means:~      This is a clinical study evaluating an innovative cell therapy procedure. The objective of~     this study was to evaluate the effects of injection of autologous stromal vascular fraction~     of adipose origin according to the system Celution ® (Cytori Therapeutics, Inc.., United~     Kingdom) in digital in patients with scleroderma cutaneous hands.~      Eleven patients with scleroderma with the hands will be included in the study. Due to the~     nature of the orphan disease, a longitudinal study be conducted, where each patient will have~     own control.~      The evaluation will be pre and post operative for a period of six months. This evaluation~     will be based on clinical criteria (trophic balance, functional) and laboratory~     (capillaroscopy, Doppler ultrasound of the arteries of the forearm, laser-Doppler tissue).~      Project schedule and implementation phases:~      The project will run over a period of twelve months. Patients will be followed for a period~     of six months. Analyzes clinical, paraclinical, and exploitation of results will be achieved~     over a period of six months.~      Expected Results: This study will validate the functional and trophic effects of reinjection~     of autologous stromal vascular fraction of adipose tissue issue on the fingers of patients~     with scleroderma.~      Conclusion: This innovative cell therapy could represent an alternative treatment for~     patients with scleroderma in check, intolerant or insufficiently relieved by medical~     treatment currently available in the scleroderma hand~   "
134006|NCT01813266|"~     Although infection with the hepatitis C virus (HCV) can result in acute hepatitis; it more~     commonly progresses to chronic hepatitis. The acute process is most often asymptomatic. Acute~     HCV typically leads to chronic infection. Chronic HCV infection is usually slowly~     progressive. Approximately 5 to 20 percent of chronically infected individuals develop~     cirrhosis over a 20-30 year period of time. Chronic HCV is the most common cause of chronic~     liver disease, cirrhosis, hepatocellular carcinoma, and the most frequent indication for~     liver transplantation in the United States.~      Screening for chronic HCV infection is crucial because chronic HCV infection is often~     asymptomatic, effective treatment is available, and untreated disease carries a high risk of~     morbidity and mortality. Expert opinion, recommendations, and guidelines for HCV screening do~     not all agree. All guidelines recommend screening patients at increased risk for HCV (ie:~     typical risk factors). In 2012, the Centers for Disease Control and Prevention (CDC)~     recommended screening all persons born between 1945 and 1965. At least two studies suggest~     that screening persons born between 1945 and 1964 or 1946 to 1970, respectively, is~     cost-effective. The studies estimated that if patients found to be HCV positive were treated~     with pegylated interferon, ribavirin, and direct acting antiviral therapy (for patients with~     HCV genotype 1), it would cost $35,700 to 37,700 per quality adjusted life-year. Screening~     based upon a birth cohort in patients without risk factors may lead to more false positive~     results.~      Currently only 1 % of patients in the birth cohort of 1945-1965 who cared for by~     Intermountain Healthcare providers have been screened. Ambulatory care physicians are not~     effectively screening patients. It is unclear whether screening based on risk factors alone~     versus screening based upon risk factors and birth cohort most effectively manages the burden~     of chronic HCV infection for patients managed by Intermountain Healthcare providers. It is~     possible that the Intermountain Healthcare population differs in risk from the U.S.~     population,making guideline application less certain.~      A well-designed prospective cohort study is needed to understand the risks and benefits of~     different HCV screening strategies on diagnostic yield and clinical outcomes.~      The investigators hypothesize that screening based on a person's history of risk factors will~     detect chronic HCV infection in 2.7 % of the population tested; this would be according to~     national average. The investigators further hypothesize that screening based on birth cohort~     and risk factors will identify roughly the same percentage in the tested population. The~     investigators anticipate usable data within three months which should give us data to~     describe and publish the effectiveness of different screening strategies.~      The investigators will identify patients with chronic HCV infection through this initial~     study who now require treatment and management. The investigators believe this group could be~     followed inexpensively for clinical endpoints for many years. This would then definitively~     define the effectiveness of screening strategies based on good evidence. No study has~     evaluated clinical outcomes associated with the different screening strategies for chronic~     hepatitis c virus infection.~   "
134007|NCT01813253|"~     This study will evaluate overall survival of nimotuzumab in combination with irinotecan~     compared to irinotecan alone in subjects with EGFR overexpressed advanced gastric or~     gastroesophageal junction cancer.~   "
134008|NCT01813240|"~     Spinal cord trauma and the consequent paraplegia are possibly among the most devastating~     injuries in soldiers and during spine surgery, and are significant in the medical, social and~     financial aspects. Limited mobility, the need for assistance in all human activities, shame,~     and many medical complications related directly to the neural deficits make paraplegia an~     important target for prevention. Our study will evaluate the efficacy of Minocycline in two~     different groups:~        1. Minimizing the neurological damage among trauma patients.~        2. Preventing neurological damage through operation in spinal tumors patients.~      2.OBJECTIVES~      The primary objectives of the trial are to determine:~        1. Efficacy of administrating minocycline in minimizing the neurological damage among acute~          spinal cord injury patients and spinal cord tumors (primary and metastases) patients?~        2. Efficacy of administrating minocycline at changing the natural history and~          rehabilitation of spinal cord trauma patients.~        3. Safety of applying minocycline in spinal cord injuries patients and spinal cord tumors?~   "
134009|NCT01813227|"~     The purpose of this study is to evaluate the safety and effectiveness of an investigational~     study drug called carfilzomib. The investigators want to find out what effects, good and/or~     bad, it has on patients and their cancer if treatment continues beyond previous carfilzomib~     treatment study.~      Carfilzomib (KyprolisTM) is approved by the U.S. Food and Drug Administration (FDA) to be~     used only in certain U.S. patients with relapsed and refractory multiple myeloma that have~     tried and failed other therapies. It has not been approved to be used for any other disease~     or condition.~      In this study, carfilzomib is referred to as an investigational study drug because it is not~     approved for use in all patients with multiple myeloma in the United States, and it is not~     approved by some regulatory authorities (the agencies that are responsible for approving the~     use of a medicine in a country such as Health Canada).~      Carfilzomib is a type of drug called a proteasome inhibitor. A proteasome is a protein found~     within cells that has the important role of identifying and marking damaged proteins that are~     needed to be destroyed by the cell for survival. The inhibition of the proteasome allows for~     damaged protein to accumulate within cells. This accumulation of damaged protein causes the~     cell to die.~   "
134010|NCT01813214|"~     This study is for patients with malignant melanoma which has spread beyond the local area and~     cannot be surgically removed, and who have melanoma tumors that are accessible for repeat~     biopsies. This research study is a way of gaining new knowledge about treatment options for~     metastatic melanoma. This research study is evaluating the effects of the drugs vemurafenib~     and cobimetinib on the immune system.~      Vemurafenib has been approved by the FDA for treatment of patients with advanced melanoma~     that harbors a B-RAF mutation. Vemurafenib works by blocking a protein called B-RAF.~     Researchers have found that a large number of melanomas have mutations (changes) in the BRAF~     gene. Genes are specific parts of your DNA that contain information on hereditary~     characteristics such as hair color and eye color. The BRAF gene codes for a protein called~     B-RAF, which is involved in sending signals in cells that can lead to cell growth. Research~     has determined that mutations in the BRAF gene at the V600 position cause a change in the~     B-RAF protein that can drive the growth and spread of melanoma cells.~      Cobimetinib (GDC-0973, XL518) is a potent and highly selective inhibitor of MEK1 and MEK2,~     central components of the RAS/RAF pathway.~      The purpose of this research study is to determine how vemurafenib and cobitmetinib may alter~     the immune system's reaction to melanoma, in order to learn how best to combine immune~     therapies with vemurafenib in the future.~   "
134011|NCT01813201|"~     The purpose of this clinical trial is to determine whether intermittent administration of~     testosterone against placebo is associated with a reduction of mortality and heart failure~     hospitalizations at 1 year, in male patients with advanced heart failure and testosterone~     deficiency.~   "
134012|NCT01813188|"~     The purpose of this clinical trial is to check the non-inferiority and lower morbidity of the~     use of bone marrow mononuclear cells seeded onto a porous matrix of calcium phosphate, for~     the consolidation of tibial bone defects (pseudoarthrosis), compared with autologous bone~     graft.~   "
134013|NCT01813175|"~     This study is initiated to investigate the effect of infant formula with added specific~     synbiotics mixture on proportion of beneficial bacteria.~   "
134014|NCT01813162|"~     The purpose of the study is determine if the local release characteristics and systemic~     exposure to tenofovir (TFV) 1% gel and a given commonly used vaginal product are impacted by~     concomitant use~   "
134015|NCT01813149|"~     40 CRPS patients will be recruited over a three-year period (target of 160 patients at all~     sites). Assessment of exclusion criteria will be undertaken during initial recruitment.~     Exclusion criteria are: <18 years; a second chronic pain syndrome that would interfere with~     pain rating; psychiatric comorbidity; pain in both hands or feet; pregnancy or breastfeeding;~     sympathectomy in the affected limb; use of topical medication; known sensitivity to alpha 1-~     adrenoceptor agonists or other contraindications. Patients will maintain their regular oral~     medications throughout the study period.~      Assessment of sympathetically maintained pain (SMP) will require an intradermal dose of~     Phenylephrine to rekindle SMP and mechanical hyperalgesia. Clonidine will be used to control~     for affects of lgometer iction and may inhibit SMP by inhibiting the release of more~     norepinephrine from sympathetic nerve terminals. Skin biopsies will be obtained under sterile~     conditions from a site of mechanical or thermal hyperalgesia using a 3mm diameter skin biopsy~     punch under local anesthesia. Samples from a mirror image site on the contralateral body side~     will also be taken.~   "
134016|NCT01813136|"~     The objective of this study is to determine the feasibility of pazopanib treatment~     interruption with reintroduction at progression in iodine refractory progressive~     Differentiated Thyroid Cancer (DTC) patients as compared to pazopanib continuous~     administration.~   "
134017|NCT01813123|"~     This study is designed to develop and test a gender-specific, web-based drug abuse prevention~     program. Study participants will be adolescent girls aged 13 and 14 years who will complete~     all measures online. Randomly assigned girls will also interact online with a skills-based~     program and subsequent annual booster sessions.~      The study's primary hypothesis is that rates of 30-day alcohol and drug use will be lower~     among girls assigned to receive the intervention.~   "
134018|NCT01813110|"~     The purpose of this study is to assess whether the marine omega-3 fatty acids can attenuate~     inflammatory responses to endotoxin challenge.~   "
134021|NCT01813071|"~     This is a research study about an experimental (investigational) oral Shigella sonnei~     (WRSS1). WRSS1 is a live vaccine that is being made to prevent disease from Shigella, which~     causes bloody, watery diarrhea. Infants and children living in developing countries~     experience the greatest consequences of this disease. The purpose of this study is to find a~     dose of the vaccine that is safe, tolerable, and develops an immune response. About 39~     healthy adults, ages 18-39, and 48 healthy children, ages 5-9, will participate in this~     study. Once the vaccine is proven safe and tolerable in adults, then it will be tested in the~     children. This study will require volunteers to stay in the research facility for several~     nights for the first dose; they will not be required to stay overnight for the second and~     third doses. Participants will be assigned to receive 1 of 3 vaccine dose levels by mouth.~     Study procedures include: stool samples, blood samples and documenting side effects.~     Participants will be involved in study related procedures for about 8 months.~   "
134022|NCT01813058|"~     Adolescent idiopathic scoliosis surgery is an extensive procedure associated with significant~     blood loss frequently requiring the transfusion of blood. Tranexamic acid (TXA) is a~     synthetic antifibrinolytic (prevents breakdown of the blood clot) that has been used to~     extensively reduce transfusion in pediatric major surgery, including cardiac, craniofacial~     and orthopedic surgery. In this prospective randomized double-blinded study, the~     investigators wish to evaluate the hypothesis that TXA is more effective than standard of~     care at decreasing blood loss and blood transfusion perioperatively in children and~     adolescents undergoing idiopathic scoliosis surgery.~   "
134023|NCT01813045|"~     Angiogenesis and fibrosis lie at the heart of a number of fundamental processes responsible~     for cardiovascular disease. In this proposal, the investigators intend to build upon a highly~     successful programme of studies exploring the cardiovascular applications of positron~     emission tomography. Specifically, the investigators will explore the potential role of a~     novel radiotracer, 18F-fluciclatide, which is a highly selective ligand for the αvβ3 and αvβ5~     integrin receptors that are up regulated during angiogenesis, and tissue fibrosis and~     remodelling. This tracer has been successfully used to assess angiogenesis in metastatic~     tumours and its uptake is suppressed by anti-angiogenic therapies. The investigators here~     propose to describe the pattern of uptake of 18F-fluciclatide in cardiovascular diseases,~     specifically acute myocardial infarction and aortic atherosclerosis. The investigators will~     correlate 18F-fluciclatide uptake with in vivo measures of angiogenesis and fibrosis. If~     successful, this novel radiotracer could provide an extremely important non-invasive method~     of assessing in vivo angiogenesis, plaque vulnerability, and tissue remodelling as well as~     potential applications in developing stem cell therapies.~   "
134024|NCT01813032|"~     Emergency Service Professionals have an increased risk of death from heart attacks when~     compared to the general public. All the emergency professions share similar responsibilities~     such as emergency call-outs and shift work. Heart disease is the commonest cause of on-duty~     death amongst fire-fighters accounting for 45% and compared with 22% in police officers and~     15% in the general population. The unique risk to fire-fighters is likely to reflect a~     combination of factors including extreme physical exertion, mental stress, heat and pollutant~     exposure.~      In this study the investigators will assess healthy career fire-fighters and age-matched~     healthy police officer control subjects following a sedentary period. The investigators will~     take blood samples to measure platelet activity (platelets are the particles in blood that~     help blood clot) and will examine how blood clots outside of the body. The investigators will~     then perform studies placing small needles in the arm to assess how the blood vessels respond~     following these duties. The investigators hypothesise that fire-fighters do not have~     pre-existing impairment of heart, blood or blood vessel function as a cumulative effect of~     their occupation, but rather these are acute and transitory effects following distinct~     fire-fighter duties. We therefore expect similar results in both occupational groups.~   "
134025|NCT01813019|"~     The purpose of this study is to determine whether AFQ056 as an add on therapy to SSRIs can~     have beneficial effects by reducing the total score of Y-BOCS (Yale and Brown Obsessive~     Compulsive Scale) in OCD patients resistant to SSRI treatment (failed SSRI over 12 weeks at~     appropriate doses).~   "
134026|NCT01813006|"~     Background~      Familial hypercholesterolemia (FH) is an inherited disease in which the level of bad~     cholesterol (LDL-cholesterol) is increased, leading to an increase in coronary heart disease~     even if adequately treated with cholesterol lowering medication (statins). Polyunsaturated~     fatty acids (PUFA) including omega-3 is known to affect the risk for coronary disease,~     however its effect on patients with FH is not known.~      The purpose of the study is to assess the effect of PUFA on patients with FH, with regard to~     inflammation measured in the blood and the effect on the blood vessels`ability to relax~     (endothelial function) by means of tonometry.~      Hypothesis~      Treatment with 4 grams of PUFA a day for 4 months will lead to an improvement in the~     endothelial function, and the treatment will also lead to a decrease in in several markers of~     inflammation and in lipids in the blood.~   "
134027|NCT01812993|"~     Although the negative impact of sleep apnea on the clinical course of acute ischemic stroke~     (AIS) is well known, data regarding non-invasive ventilation in acute patients are scarce.~     Several studies showed its tolerability, safety and signals-of-efficacy, yet no controlled~     randomized sequential phase studies currently exist that aim to establish the efficacy of~     early non-invasive ventilation in AIS patients. The main hypothesis for this study is that~     early non-invasive ventilation with automated bilevel positive airway pressure (auto-BPAP)~     positively affects short-term clinical outcomes in AIS patients. This is a multicenter,~     prospective, randomized, controlled, third rater-blinded, parallel-group trial. Patients with~     AIS with proximal arterial obstruction and clinically suspected sleep apnea will be~     randomized to standard or standard stroke care plus auto-BPAP. Auto-BPAP will be initiated~     within 24 hours from stroke onset and performed for a maximum of 48 hours during diurnal and~     nocturnal sleep. Patients will undergo cardiorespiratory polygraphy between day 3 and 5 to~     assess sleep apnea. The primary endpoint is any early neurological improvement on the NIHSS~     at 72 hours from randomization. Safety, tolerability, short-term and 3 months functional~     outcomes are assessed as secondary endpoints by un-blinded and blinded observers~     respectively. This study will provide data to power a subsequent phase III study.~   "
134028|NCT01812980|"~     The overall aim of this project is to evaluate the immunogenicity of TIV vaccination in~     HIV-infected non-pregnant women in 2013. Safety data including solicited local and systemic~     reactions to the vaccine will also be assessed.~   "
134030|NCT01812954|"~     This study is health economic analysis of medicinal treatment options for moderate-to-severe~     psoriasis vulgaris from the societal perspective. Efficacy data and other clinical outcomes~     will be derived from an up-to-date meta-analysis of randomized clinical trials (RCTs) for~     moderate-to-severe psoriasis. Direct and indirect costs will be extracted from various~     different sources, including summary of product characteristics (SPCs) and the German S3~     guideline on psoriasis care, health care utilization data and official statistics.~      The study aims to investigate the comparative cost-effectiveness of biologic and conventional~     systemic treatments currently (as of June 1st, 2012) approved for moderate-to-severe~     plaque-type psoriasis in Germany. Effectiveness will be measured by means of the pooled~     (Psoriasis Area and Severity Index) PASI-75 response rates as reported in RCTs Direct cost as~     well as indirect cost will be considered.~   "
134031|NCT01812941|"~     The purpose of this project is to evaluate the level of mitochondrial dysfunction several~     patient populations: Burn, trauma, and control group of healthy volunteers.~      Study hypothesis: Increased plasma concentrations of a newly discovered inflammatory~     mediated, called mtDNA DAMPS associated with the occurrence of multi-organ dysfunction~     syndrome in severly injured patients.~      As the severity of a burn injury or trauma injury increase, so will systemic mitochondrial~     dysfunction.~   "
134032|NCT01812928|"~     Flexible cystoscopy has diagnostic as well as therapeutic role in many patients presenting in~     urology clinic with lower urinary tract symptoms (frequency, nocturia etc) and hematuria~     (blood in urine).~      Pain associated with cystoscopy varies from patient to patient, majority requires local~     anesthesia or lubricant solution only. During flexible cystoscopy, lubrication, use of~     topical anesthesia and duration of cystoscopy are recognized as important factors~     contributing in severity of pain of which use of intraurethral gel left to individual~     preference. Various studies are available reporting the pain perception with use of various~     intraurethral gels. Even the highest level of evidence is unable to resolve the query.~      With this study the investigators hypothesize that pain perception (recorded in form of pain~     score) during flexible cystoscopy can be reduced with use of per operative diclofenac(Non~     Steroidal Anti Inflammatory Drug)suppository in comparison to plain gel alone.~      With better control of pain the investigators aim to increase patient comfort and compliance~     which will increase the patient satisfaction rate and early return to work.~   "
134033|NCT01812915|"~     When using nitrous oxide for general anesthesia, nitrous oxide diffusion induces intracuff~     hyperinflation of the endotracheal tube. Furthermore the difference among various types of~     cuffed endotracheal tubes in cuff pressure behavior during nitrous oxide exposure.~      TaperGuard(TM) tube has been newly introduced and has tapered-shape cuff. In vitro study, the~     intracuff pressure of TaperGuard(TM) tube was lower than that of conventional tube with~     cylindrical-shaped cuff of the conventional tube(Hi-Lo(TM) tube). Therefore, this clinical~     study is needed to evaluate the intracuff pressure during general anesthesia with nitrous~     oxide exposure.~   "
134034|NCT01812902|"~     Prostate cancer is currently the second most common cause of cancer death in men in Western~     countries. Lymphadenectomy is the gold standard procedure for staging pelvic lymph node and~     is classically indicated in intermediate and high risk prostate cancer patients and is held~     at the same time of prostatectomy. A traditionally pelvic lymphadenectomy covers the~     obturator chain bilaterally. Recently, some studies have demonstrated the existence of lymph~     node involvement outside the traditional boundaries of classical lymphadenectomy,~     recommending therefore extended dissection; this also includes the external / internal /~     common iliac chains and presacral. Thus lymphadenectomy, according to these authors, would~     also has a therapeutic role, besides helping in better staging. Although some retrospective~     studies report an association between lymphadenectomy and tumor progression, the exact impact~     of extended lymphadenectomy in oncological outcome of patients with prostate cancer is not~     clearly established, mainly by lack of prospective randomized studies on the subject . The~     study objectives are to compare the oncologic results of extended lymphadenectomy versus~     limited in order to elucidate the role of extended dissection in lymph node staging and~     results of treatment in terms of increased tumor cure. The investigators also intend to~     identify patients who may benefit from oncologically extended procedure. To do this, the~     investigators will evaluate prospectively patients diagnosed with prostate cancer at~     intermediate or high risk indicating lymphadenectomy and radical prostatectomy. These~     patients will be randomized to the extended versus limited lymphadenectomy and the~     investigators will compare the lymph node metastasis and pattern of spread of prostate~     cancer, as well as biochemical relapse-free survival, freedom from progression to metastasis~     and cancer-specific survival.~   "
134035|NCT01812889|"~     The purpose of this study is to determine the safety, local tolerability and pharmacokinetic~     parameters of TOL-463 intravaginal dosage forms in both healthy, nonpregnant females~     following single dose administration (Part 1), and in nonpregnant women with vaginitis~     following multi-dose administration (Part 2).~   "
134036|NCT01812876|"~     This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy~     of Chinese Medical Sciences in December 2012.~      It was funded by China major scientific and technological specialized project for~     'significant new formulation of new drugs'.~      The purpose of this study is to make a cohort event monitoring to see whether and how~     Shenqifuzheng injection in hospital results in adverse events or adverse drug reactions.~   "
134037|NCT01812863|"~     The purpose of this study is to determine if US-guided supraclavicular anesthetic blocks~     reduce postoperative pain, use of rescue medication, and improve functional outcomes in~     children who underwent surgery for supracondylar humerus fractures.~   "
134038|NCT01812850|"~     The purpose of this study is to assess temporomandibular joint (TMJ) symptoms and night~     muscle activity in an objective manner, in addition to daytime bruxism and clenching, as~     reported by the patient, following the start of orthodontic treatment with Invisalign®. A~     baseline evaluation of all measures will be used as control data, while different time points~     will be used to evaluate the evolution of patients' symptoms over the course of six months~     (the duration of the study).~   "
134039|NCT01812837|"~     The global aim of this study is to investigate how microneedles can facilitate the~     penetration and efficacy of photodynamic therapy in the treatment of actinic keratoses~      The specific aims are as follows:~        1. Investigate whether pretreatment with microneedles enhances penetration of topical~          aminolevulinic acid (ALA) that is marketed as Levulan® Kerasticks by DUSA~          pharmaceuticals Inc.~        2. Investigate whether pretreatment with microneedles can decrease the required incubation~          times of the topical ALA prior to exposure to blue light photodynamic therapy.~   "
134063|NCT01812525|"~     Our study will investigate inhalation therapy of NaCl 3% compared to standard therapy with no~     inhalation in the treatment of moderate to severe bronchiolitis. The impact on length of~     hospital stay will be analyzed.~   "
134556|NCT01806077|"~     This study is a Phase I, intravenous, single-dose escalation study to evaluate the safety,~     tolerability, pharmacokinetics and pharmacodynamics of PZ-128 (pepducin inhibitor of PAR1) in~     subjects with vascular disease or who have 2 or more coronary artery disease (CAD) risk~     factors.~   "
134040|NCT01812824|"~     This study is to examine the effectiveness of a health communication system (Gabby) that~     assesses preconception health risks and tailors the intervention to each subject, based on~     her health risks.~      There is a need to develop practical tools that can be used to identify preconception health~     risks and will facilitate the initiation of intervention for these risks; this project~     specifically targets young Black or African American women in order to reduce major~     disparities in birth outcomes. Clinicians do not have time to assess for over 100~     preconception health risks that can impact birth outcomes; this system can streamline that~     assessment and create a personalized list of risks. Patients can then share their list with~     clinicians to make their healthcare visits more effective.~      This study involves a pilot of the system through the Preconception Peer Educator (PPE)~     Program, which is a program created by the Office of Minority Health. The program began in~     historically black colleges in the United States, with the purpose of training students to~     reach out to their community to educate about the increased risk of preterm birth, low birth~     weight and infant mortality among African Americans. The PPEs teach about preconception~     health, or getting healthy before pregnancy, to increase the chances of having a healthy~     baby. Now the PPE program has expanded to colleges in over 20 states across the country.~   "
134041|NCT01812811|"~     The functionality and reproducibility of pulse wave analysis is investigated in 20 type 2~     diabetic patients who had two 24 hour measurements performed within one week with the~     Arteriograph24 equipment.~   "
134042|NCT01812798|"~     An important gap in the management of peanut allergy is that we do not know the threshold~     dose, below which most peanut allergic individuals will not react. There is likely a spectrum~     of reactivity to peanut where some individuals react to trace doses, whereas others are able~     to tolerate larger doses. The purpose of this study is to determine the minimum threshold~     dose needed to cause a mild objective reaction when peanuts are consumed by peanut-allergic~     individuals in a carefully controlled clinical setting. 30 peanut-allergic participants aged~     7-65 years will undergo a two-day, double blind placebo controlled food challenge.~     Participants will be gradually fed increasing amounts of peanut, or placebo, until objective~     allergic symptoms are observed. Statistical modelling of individual threshold doses will be~     used to determine a population threshold dose, or a level of peanut to which 90% of the~     peanut-allergic population will not react. Knowledge of threshold doses at an individual and~     population level is valuable in that it provides critical information for the management of~     peanut allergy by individuals, their caregivers and health professionals, as well as~     knowledge of allergen risks to public health agencies and the food industry.~   "
134043|NCT01812785|"~     The goal is to improve the evidence-based management of fever cases seen in outpatient~     clinics in malaria endemic countries, through a better understanding of the value of accurate~     malaria diagnosis, and through an improved understanding of the other causes of fever in~     children. The objective is to describe systematically (as much as possible) the etiologies of~     fever in children in an urban and in a rural environment of sub-Saharan Africa.~   "
134044|NCT01812772|"~     RESEARCH QUESTION Do ureteric stents with tethers, left in-situ for 1-2 weeks, increase the~     rate of stent bacterial colonization, urinary bacterial colonization and stent related lower~     urinary tract symptoms compared to stents without tethers?~      HYPOTHESIS We hypothesize that ureteral double-J stents with tethers increase the rate of~     stent bacterial colonization, but do not increase the rate of urinary bacterial colonization~     or stent related lower urinary tract symptoms compared to stents without tethers when left~     in-situ for 1-2 weeks.~   "
134045|NCT01812759|"~     The goal of this clinical research study is to learn if fentanyl nasal spray can help~     decrease pain related to cancer when used with other drugs for pain. Researchers also want to~     know if this drug can help decrease the length of your stay in the Emergency Department.~      In this study, fentanyl nasal spray will be compared to a placebo nasal spray. A placebo is~     not a drug. It looks like the study drug but it is not designed to treat any disease or~     illness. It is designed in this study to be compared with the study spray to learn if the~     study spray has any real effect.~      You will also be given intravenous (IV) pain drugs. You will be given these drugs even if you~     decide not to take part in this study.~   "
134046|NCT01812746|"~     The purpose of this study is to evaluate the efficacy and safety BIND-014 in patients with~     metastatic castration-resistant prostate cancer (mCRPC).~   "
134047|NCT01812733|"~     The objective of the non-interventional study is to compare the quality of life, health care~     resource use and costs between the use of a combination of oxycodone and naloxone (Targiniq)~     versus oxycodone and laxatives for patients with severe pain, and to evaluate the~     cost-effectiveness of treatment with Targiniq.~   "
134048|NCT01812720|"~     This phase II trial studies how well carfilzomib and dexamethasone work in treating patients~     with multiple myeloma who previously underwent a stem cell transplant. Carfilzomib may stop~     the growth of cancer cells by blocking some of the enzymes needed for cell growth.~     Immunosuppressive therapy, such as dexamethasone, may improve bone marrow function and~     increase blood cell counts. Giving carfilzomib together with dexamethasone may be an~     effective treatment for multiple myeloma.~   "
134049|NCT01812707|"~     Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds proprotein~     convertase subtilisin/kexin type 9 (PCSK9).~      Primary Objective of the study:~      To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels~     after 12 weeks of treatment in comparison with placebo in participants with LDL-C ≥100 mg/dL~     (≥2.59 mmol/L) on ongoing stable atorvastatin therapy.~      Secondary Objectives:~        -  To evaluate the effects of alirocumab on other lipid levels after 12 weeks of treatment~          in comparison with placebo~        -  To evaluate the safety and tolerability of alirocumab~        -  To evaluate the development of anti-alirocumab antibodies~        -  To evaluate the pharmacokinetics of alirocumab~   "
134095|NCT01812096|"~     Intravenous injection is the standard administration route of bortezomib; however,~     subcutaneous administration is an important alternative. We want to compared the~     pharmacokinetic of subcutaneous versus intravenous bortezomib at the approved 1•3 mg/m2 dose~     and twice per week,on days1, 4, 8 and 11 of 21-day cycles, schedule in newly diagnosed~     patients of multiple myeloma.~   "
134874|NCT01801917|"~     This study assessed the efficacy, safety and tolerability of BAF312 administered orally in~     patients with clinically active polymyositis and also in patients with polymyositis who had~     shown inadequate response to corticosteroids and or DMARDs (disease modifying antirheumatic~     drugs).~   "
134050|NCT01812694|"~     Background:~      - LIFE-Moms (Lifestyle Interventions for Expectant Moms) is a national project that is~     studying pregnant women who are overweight or obese. It is looking at ways they can manage~     their weight gain in pregnancy and how this may affect them and their babies health at birth~     and through the first year. Researchers want to recruit pregnant women who are being treated~     at the Phoenix Indian Medical Center. They will participate in a two-part study.~      Objectives:~      - To study pregnant women who are in the LIFE-Moms project at the Phoenix Indian Medical~     Center.~      Eligibility:~        -  Pregnant women at least 18 years of age who are overweight or obese.~        -  Participants must be receiving care at the Phoenix Indian Medical Center.~        -  Participants must be having only one child in their pregnancy (no twins or other~          multiple births).~      Design:~        -  This study will have two parts. The first part will have three visits to obtain data~          about health early in pregnancy. It will also let participants and researchers find out~          if the participants are eligible and should continue in the second part of the study. In~          the second part, participants will be monitored throughout their pregnancy and during~          the first year after the baby s birth to test the effects of a lifestyle intervention to~          control weight gain during pregnancy.~        -  On the Part 1 study visits, participants will have a physical exam and medical history.~          They will provide blood, urine, hair, and other samples to be examined for possible~          genetic conditions.~        -  For the Part 2 study visits, participants will be placed in one of two treatment groups.~          Each group will receive the same prenatal and postnatal care that they would get if they~          did not join the study.~        -  The first group will have a lifestyle intervention program. They will spend about 2~          hours every week with other members of their group to learn diet and activity behaviors~          that may help with their health.~        -  The second group will have an enhanced care program. They will be given additional~          information about health and pregnancy and be invited to attend three classes to learn~          about staying healthy during pregnancy.~   "
134051|NCT01812681|"~     Experimental and observational studies have shown that vitamin D deficiency may be associated~     with an increased risk for non-bone diseases and/or abnormal development for the other~     systems of fetus. The aim of this study is to determine the relationship between cord blood~     25-hydroxyvitamin D (25 (OH) D) concentrations and the subsequent risk of morbidities~     including RDS, PDA, NEC, BPD AND ROP in preterm infants.~   "
134052|NCT01812668|"~     This pilot clinical trial studies cabozantinib-s-malate in treating patients with~     hormone-resistant metastatic prostate cancer. Cabozantinib-s-malate may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth~   "
134053|NCT01812655|"~     Relief of severe burn wound care pain may require both medications to relieve pain and~     non−medication interventions,such as distraction. Little is known about distraction's~     effectiveness. Virtual reality may be an effective distraction. The aims of this study are~     1)to evaluate the effect of virtual reality (VR), a newer interactive kind of distraction,~     compared to passive distraction (PD) by watching a movie, and usual care (SC) that is~     provided by the nurses, on pain experienced by adolescents during burn wound care and 2)to~     determine the relationship among anxiety, desire for distraction, and engagement with~     distraction on the pain.~   "
134054|NCT01812642|"~     The purpose of this study is to evaluate safety, tolerability and pharmacokinetics (explores~     what the body does to the drug) of JNJ-37822681 in participants with stable schizophrenia~     (psychiatric disorder with symptoms of emotional instability, detachment from reality, often~     with delusions and hallucinations, and withdrawal into the self).~   "
134055|NCT01812629|"~     The study objective is to assess the growth, tolerance and efficacy of a complete amino~     acid-based medical food in children with chronic diarrhea.~   "
134056|NCT01812616|"~     An open-label phase to assess the frequency and severity of adverse events in recurrent~     glioblastoma patients receiving Sativex in combination with dose-intense Temozolomide (Part~     A). A randomisation phase to assess the safety of Sativex compared with placebo (Part B).~     Part B will be reported here.~   "
134057|NCT01812603|"~     An open-label phase to assess the frequency and severity of adverse events in recurrent~     glioblastoma patients receiving Sativex in combination with dose-intense Temozolomide (Part~     A). A randomisation phase to assess the safety of Sativex compared with placebo (Part B).~     Part A will be reported here.~   "
134058|NCT01812590|"~     Subjects with type 2 diabetes will be stratified into two-quantiles based on ambient~     hyperglycemia (fasting glucose and HbA1c) and then the effects of a single aerobic exercise~     bout (1-hour at 50%VO2max) on pancreatic endocrine function will be determined.~   "
134059|NCT01812577|"~     Percutaneous radiofrequency ablation of liver lesions causes patients acute pain during and~     after the procedure. During the procedure patients need deep sedation and cannot be~     collaborative. Furthermore post-operative analgesia is necessary. The aim of this study is to~     evaluate if the ultrasound-guided paravertebral block (TPVB)with a single injection can~     provide anesthesia and post-operative analgesia in these patients.~   "
134060|NCT01812564|"~     The purpose of this study is to evaluate the therapeutic benefit of utilizing complex growth~     factor preparations (Platelet Rich Plasma (PRP) in the management of acute hamstring~     injuries.~      The hypothesis is that the time to return to sport is shorter in the patient group treated~     with Complex Growth Factor Preparations (PRP) in combination with exercise therapy in~     comparison with 2 control groups:~        -  the patient group treated with Platelet Poor Plasma (PPP) injections in combination with~          exercise therapy (control injection AND usual care).~        -  the patient group treated with exercise therapy (usual care)~   "
134061|NCT01812551|"~     Cystic fibrosis (CF) -- an autosomal recessive genetic disease affecting about 60,000~     individuals worldwide, including about 3,800 in Italy -- is often associated with low bone~     mineral mass. The current aggressive therapies have ensured a much longer survival of CF~     patients but this has led to a higher frequency of osteoporosis and bone fractures, a serious~     problem which not only affects quality of life, but also hinders further therapeutic~     measures.~      The aim of this study, conducted on a large group of children, adolescents and young adults~     with CF, has been the evaluation of bone mass changes after 1 year of a simple treatment with~     RDA-adjusted dietary calcium plus 25-OH vitamin D supplementation, and the feasibility and~     efficacy of alendronate treatment (for another year) in patients not responding to calcium +~     25-OH vitamin D alone.~   "
134062|NCT01812538|"~     This study is conducted to evaluate the effectiveness of DIC075V on ventricular~     repolarization in healthy subjects compared to placebo after a single dose of DIC075V~     administered intravenously (IV) and to evaluate ECG assay sensitivity by evaluating the~     baseline-adjusted effect of a single oral (PO) moxifloxacin 400 mg dose on ventricular~     repolarization in healthy subjects compared to placebo. Other secondary objectives are as~     follows:~        -  To evaluate the effect of DIC075V on ventricular repolarization in healthy subjects~          compared to placebo at the Tmax of diclofenac and hydroxypropyl-β-cyclodextrin (HPβCD).~        -  To determine if there is a pharmacokinetic/pharmacodynamic (PK/PD) relationship between~          the duration of the QTc intervals and diclofenac and HPβCD plasma concentrations.~        -  Obtain additional pharmacokinetic (PK) information on diclofenac and HPβCD in healthy~          subjects.~        -  Provide additional safety information.~   "
134064|NCT01812512|"~     People with heart failure (HF) are hospitalized over a million times a year in the US at a~     cost over $39 billion dollars. About half of the patients are readmitted within 30 days.~     Despite a number of institutional reforms, cost and readmissions remain high in the VA. The~     VA Home Telehealth (HT) monitoring program decreases preventable readmissions, but HF~     readmissions remain increased in the VA. Despite an active and effective HT program, the~     Charleston VAMC has the highest HF readmission rate in VISN 7. Though the HT program~     introduces communication, self-management, and shared decision-making in initial training,~     previous QUERI RRP evaluation identified lower than expected levels of specific communication~     practices associated with the promotion of HF self-management and shared decision-making,~     mediated by the requirements of the technology.~   "
134065|NCT01812499|"~     Inhospital the blood transfusion process consists of many phases: ordering the blood product,~     analysis of the blood sample, delivery, transport and storage of the blood product and~     administration. In each of these phases (near) accidents may occur. A severe transfusion~     incident refers to the transfusion of a wrong blood product, whereas a near miss is detected~     before transfusion.~      In 2010 the University Hospitals Leuven introduced a new electronic patient incident report~     system for transfusion events.~      In this study the investigators will analyze the reported blood transfusion events to detect~     the most common causes of blood transfusion events and the weakest link in the blood~     transfusion chain.~   "
134066|NCT01812486|"~     A randomized clinical trial was initiated to investigate whether a reduction of the dose to~     the elective nodal sites and the swallowing apparatus delivered by IMRT would result in a~     reduction of acute and late side effects without compromising tumor control.~   "
134067|NCT01812473|"~     The purpose of this study is to investigate the influence of hypoalbuminemia on the protein~     binding characteristics of the antifungal drug voriconazole in ICU patients.~   "
134068|NCT01812460|"~     We want to test the hypothesis, that resistance training by the use of weigth cuffs on the~     angle can prevent loss or improve the strength of the quadriceps muscle in COPD patients~     admitted to hospital due to an exacerbation. The training is started at day one of admittance~     and the strength of the quadriceps is measured by a portable dynamometer.~   "
134069|NCT01812447|"~     EMPROVE is a multicenter, prospective, randomized, controlled study designed to evaluate the~     safety and long-term effectiveness of the Spiration Valve System in patients with emphysema.~      Patients appropriate for the EMPROVE study are those who are currently on medical treatment~     but still symptomatic.~      EMPROVE also accepts α-1 antitrypsin deficiency patients.~   "
134070|NCT01812434|"~     Hypothesis 1: Treatment of heart transplant recipients with sildenafil, a PDE-5 inhibitor,~     will improve small artery elasticity (SAE) when compared to placebo.~      Hypothesis 2: PDE-5 inhibition will improve endothelial function, resulting in increased~     production of nitric oxide, reduced activation of circulating endothelial cells, and~     increased endothelial progenitor cells.~   "
134071|NCT01812421|"~     Patients with a diagnosis of ischemic stroke or TIA (ISTIA), who are treated at hospital are~     asked to participate in our pre specified hypertension health education protocol (HHEP) after~     discharge from our hospital.HHEP was used as secondary prevention treatments of stroke and~     cardiovascular diseases.~      HHEP consists of several items such as controlling the patient's hypertension level,~     monitoring the adherece of antihypertensive agents, reducing risk factors of hytertension~     like tobacco smoking, obesity, and motivating the patient to physical activity and to a~     healthy diet.~      Patients will receive visits by a study nurse with the aim of supervising, monitoring, and~     recording the adherence of HHEP. The patients will be classified as different adherence level~     at the end of the study according to their adherence condition.~      This study is aimed at testing the hypothesis that controlling hypertension and its risk~     factors was more effective than those do not receive HHEP in reducing the recurrence of~     stroke and cardiovascular diseases.~   "
134072|NCT01812395|"~     New devices and techniques are coming into use everyday. Ultrasonic dissectors (UDs) are such~     new devices which is a practical alternative to the usage of scalpel and sutures. UD's cause~     overheating of neighboring tissues in an area of 1 to 3 millimeters. Due to the generated~     heat UDs might cause nerve injury. The investigators would like to see if usage of UDs during~     thyroidectomy poses a risk for superior laryngeal nerve injury compared to conventional~     thyroidectomy.~   "
134073|NCT01812382|"~     This feasibility study will allow for the determination of the in vivo recovery and time of~     dialysis to optimize a future thorough microdialysis study. This is a single session, open~     label study to evaluate the feasibility of microdialysis for Retapamulin in healthy subjects.~     Three healthy subjects will be enrolled and complete the study procedures. Subjects will be~     admitted to the research unit on Day 1 and three microdialysis probes will be placed in the~     thigh of each subject prior to the start of the microdialysis procedure. After normal saline~     solution infusion for 30 minutes, a Retapamulin solution will be infused for 90 minutes.~     Saline perfusion will occur during the washout period. Microdialysis sampling will be done~     for 30 minutes (during the last 30 minutes of drug perfusion) and dialysate sample collection~     will continue every 30 minutes for 4 hours. The approximate duration of study including~     follow-up is 4 days.~   "
134085|NCT01812226|"~     The aim of this study is to compare the predictive validity and reliability of PEth testing~     at detecting alcohol use in post liver transplant patients. A prospective cohort study will~     be used to test the primary hypothesis. Subjects enrolled in the study will be followed for~     12 months with biomarker levels drawn at baseline, six and 12 months. The baseline interview~     will inquire about the previous 30 day alcohol and tobacco use; lifetime and 12 month~     Diagnostic and Statistical Manual-IV criteria for alcohol abuse and/or dependence; prior~     alcohol treatment; history of abstinence prior to transplant; co-morbid medical issues; and~     depression. The six and 12 months interview will focus on previous 30 day alcohol use. The~     baseline, six and 12 months interviews will be conducted face-to-face at each site. While~     many patients who receive a transplant do not live near the academic medical center that~     performed the surgery patient, they normally have a transplant clinic visit 1-2 times per~     year. Medical records and transplant databases will be assessed to assess the other variables~     of interest.~   "
134086|NCT01812213|"~     To investigate whether [18F]NAV4694 positron emission tomography (PET) scan findings have the~     ability to distinguish subjects with mild cognitive impairment (MCI) who progress to~     Alzheimer's disease (AD) from those who do not.~   "
134087|NCT01812200|"~     Background:The acute coronary syndrome (ACS) is a complication of coronary artery disease~     (CAD) and associated with increased mortality. Dual antiplatelet therapy of acetylsalicylic~     acid (ASA) with P2Y12 receptor antagonists such as clopidogrel is a cornerstone in the~     treatment of patients with advanced CAD. Due to delayed onset of action, intersubject~     variability or resistance to clopidogrel, different platelet aggregation inhibitors have been~     developed. Ticagrelor is a reversible P2Y12 receptor antagonist with superior efficacy~     compared to clopidogrel in the prevention of cardiovascular death in these patients.~      Atrial fibrillation (AF) is also associated with thromboembolic events and substantial~     mortality. Beside vitamin K antagonists (VKA, phenprocoumon) for stroke prevention in~     patients with AF, the direct factor Xa inhibitor rivaroxaban and the direct thrombin~     inhibitor dabigatran have recently received approval for prophylactic treatment of patients~     with non-valvular AF.~      However, there is a lack of efficacy or safety data for the combined impact of antithrombotic~     drugs in patients requiring arterial and venous thromboembolic prophylaxis due to their~     underlying co-morbidities.~      Study objectives: To evaluate the effect of ticagrelor + ASA in combination with dabigatran,~     rivaroxaban or phenprocoumon at steady state on markers of coagulation activation. The~     effects on coagulation activation will also be studied after a single dose of dabigatran,~     rivaroxaban or ticagrelor and at a therapeutic INR of phenprocoumon.~      Study design: A single-centre, prospective, randomized, controlled, analyst-blinded study in~     three parallel-groups. Subjects will receive ticagrelor + ASA in combination with dabigatran~     (treatment A), rivaroxaban (treatment B) or phenprocoumon (treatment C). All IMPs will be~     administered at doses indicated for stroke prevention in AF or ACS. Markers on thrombin~     generation and platelet activation will be studied in venous blood where coagulation is in~     resting state and in shed blood where the clotting system is activated in the~     microvasculature in vivo: prothrombin fragment 1+2 (F1+2), thrombin-anti-thrombin (TAT),~     β-thromboglobulin (β-TG), D-Dimer, thromboxane B2 (TxB2), CD40 ligand (CD40L), p-Selectin.~     Further, the endogenous thrombin potential (ETP), inhibition of factor Xa activity, activated~     partial thromboplastin time (aPTT), prothrombin time (PT), Biophen® and Hemoclot® will be~     assessed in venous blood.~      Study population: A total of 60 healthy, non-smoking and drug-free male volunteers will be~     enrolled in this trial and randomized into one of three balanced groups (treatment A, B and~     C; n = 20 per group).~      Main outcome variables: β-TG, F1+2 and TAT in shed blood~      Additional outcome variables:~        -  D-Dimer, TxB2, CD40L and p-Selectin in shed blood~        -  β-TG, F1+2, TAT, D-Dimer, TxB2, CD40L, p-Selectin, ETP, aPTT, PT, inhibition of factor~          Xa, Biophen® and Hemoclot® in venous blood~      Risk/ benefit assessment:Total blood loss will be, dependent on treatment allocation, between~     330 ml and 510 ml throughout the entire study period of 4 - 5 weeks. This amount of venous~     blood is considered to be acceptable in this healthy population. Blood sampling procedures~     may cause mild and transient pain. A minor haematoma may occur at the site of needle~     insertions. Bleeding time incisions may leave small persistent scars. Administration of the~     study drugs, in particular as triple combination for 5 days, results in transient~     hypocoagulability and may cause overt or occult bleeding. The risk is considered low in the~     healthy subjects under study. Continuous monitoring of safety parameters (haemoglobin,~     haematocrit, platelet count, coagulation) and surveillance of the overall status will be~     performed during study participation. Subjects will be instructed to avoid vigorous physical~     exercise and handling of hazardous machinery during study participation. ASA, dabigatran and~     rivaroxaban can cause gastrointestinal discomfort. Other side effects are rare.~      The combination of these novel anticoagulants (dabigatran, rivaroxaban, ticagrelor) has not~     been investigated so far. Conducting this study in a healthy population limits potential~     bleeding risk reported from drug interactions and impaired liver or renal function, which may~     influence the pharmacokinetics and -dynamics of the investigational products.~      This study can provide information on haemostatic system activation in vivo during triple~     treatment with antithrombotic drugs, which is indicated for patients with AF and ACS. The~     results of this study may provide dosing guidance for risk reduction of patients with ACS and~     AF.~   "
134074|NCT01812369|"~     Radical cystectomy remains the gold standard treatment for invasive non metastatic~     transitional cell cancer (TCC) of the bladder. In contemporary series, specific survival~     rates are about 60 to 65% at 5 years, decreasing for locally advanced disease to 45-50% in~     patients with nonorgan-confined lymph-node negative tumours and to 30-35% in patients with~     lymph node positive tumours. Perioperative chemotherapy (adjuvant ou neoadjuvant) has been~     developed in order to improve these results. Thanks to randomized trials and meta-analysis,~     it can be concluded that perioperative chemotherapy increases overall survival with an~     absolute benefit of 5%, equating to a survival rate of 50% at 5 years for nonorgan-confined~     tumours. However, the chemotherapy administration time and the optimal chemotherapy regimen~     to be delivered are not yet determined. Meta-analyses have shown that the benefit is only~     observed for chemotherapy regimens including cisplatin. In daily management 4 to 6 cycles of~     gemcitabine and cisplatin are delivered since this combination has been shown to yield a~     similar efficacy with a better tolerance as compared to the MVAC regimen (methotrexate,~     vinblastine, doxorubicin and cisplatin) in the metastatic setting. As HD-MVAC has been shown~     to be associated with higher response rates than MVAC in bladder metastatic disease, also a~     better efficacy of HD-MVAC can be suspected in the perioperative setting. Investigators~     therefore designed a randomized phase III study to compare the efficacy of GC and HD-MVAC in~     term of progression-free survival in patients for whom chemotherapy has been decided, before~     or after radical cystectomy. Secondary endpoints include overall survival, side effects,~     response rate in the neoadjuvant setting and ancillary studies focusing on gemcitabine and~     cisplatin sensitivity. The total number of patients projected is 500. The number of patients~     is based on the median progression-free survival rate of 50% at 3 years observed in patients~     treated with GC (standard arm A) in the perioperative setting. An absolute improvement of 10%~     (HR=0.74) is expected with HD-MVAC (experimental arm B) with a=0.05 and b=0.20. An interim~     analysis is planned after the occurrence of 174 events. With an estimated uniform accrual~     rate of 140 patients per year for 3.5 years and exponential survival, the final analysis is~     expected to occur 8 years after the start of the trial.~   "
134075|NCT01812356|"~     The aim of this study is compare the surgical convenience and early and long-term outcomes of~     cryomaze procedure using nitrous oxide with using Argon gas.~      The investigators will analyze the pathologic findings of atrial tissue after cryoablation~     using two probes and early and long-term outcomes with Holter monitoring. Atrial fibrillation~     burden 3 months and 1 year postoperatively and atrial activity will be checked.~   "
134076|NCT01812343|"~     Estimate the response of ankle to brachial pressure index to incremental maximum exercise in~     subjects free from prior cardiovascular disease.~      Estimate morbi-mortality of included patients over a 5 years follow up.~   "
134077|NCT01812330|"~     The purpose of this study is to compare the efficacy and safety of ticagrelor with~     clopidogrel~   "
134078|NCT01812317|"~     Fire-fighters are at increased risk of death from heart attacks when compared to other~     emergency service professionals whose jobs involve similar components such as emergency~     call-outs and shift work. The unique risk to fire-fighters is likely to reflect a combination~     of factors including extreme physical exertion, mental stress, heat and pollutant exposure.~      In the largest analysis of cause of death amongst on-duty fire-fighters, fire-fighter deaths~     were classified according to the duty performed during the onset of symptoms or immediately~     prior to any sudden death. The majority of deaths due to a cardiovascular cause (i.e. heart~     attack) occurred during fire-suppression whilst this activity represented a relatively small~     amount of a fire-fighters professional time. Fire simulation training centers offer a unique~     opportunity to assess the heart, blood and blood vessel response to fire suppression in a~     controlled environment.~      In this study the investigators will assess healthy career fire-fighters on two occasions:~     following a fire-suppression training exercise in a purpose built real-fire training center,~     and following a sedentary period as a control. The investigators will take blood samples to~     measure platelet activity (platelets are the particles in blood that help blood clot) and~     will examine how blood clots outside of the body. The investigators will then perform studies~     placing small needles in the arm to assess blood vessel function following fire suppression.~     By undertaking this comprehensive assessment of blood, blood vessel and heart function we~     hope to understand the mechanisms whereby the risk of a heart attack is influenced by fire~     suppression. The investigators hypothesize that following the fire-suppression exercise~     firefighters blood will clot more readily and their blood vessels will not relax properly~     which are two of the main processes in the development of a heart attack.~   "
134079|NCT01812304|"~     This trial aims to assess the hypothesis that hands-on training of vaginal breech delivery on~     a pelvic model is significantly better in terms of a technical skills scoring system compared~     to frontal teaching.~   "
134080|NCT01812291|"~     The study examines the efficacy of a stepped care approach for depressed diabetes patients~     (first study objective). 256 patients with diabetes and comorbid subthreshold or clinical~     depression will be randomly assigned to either a stepped care approach or a~     treatment-as-usual condition. The stepped care approach consists of three treatment steps~     comprising diabetes-specific cognitive-behavioral therapy (CBT) (group), depression-specific~     CBT (single), and psychotherapeutic and/or psychiatric treatment (single). Patients assigned~     to the stepped care approach will be treated stepwise until a clinically significant~     reduction of depressive symptoms is attained or all three treatment steps are passed.~      The primary outcome of the first study objective is a clinically significant reduction of~     depressive symptoms in the 12-month follow-up. Secondary outcomes are reduction of~     diabetes-related distress and improvement of well-being, health-related quality of life,~     diabetes acceptance, diabetes self-care, and glycaemic control. Additionally, cost-benefit~     analyses will be performed.~      The second study objective is to analyse associations between diabetes, depression, and the~     serum levels of inflammatory markers.~      The third study objective is to analyse the courses of depressive conditions in diabetes with~     regard to recovery rates and incidence of major depression.~   "
134081|NCT01812278|"~     The goal of this study is to determine whether the ACT website provides higher quit rates~     than a current standard smoking cessation website.~   "
134082|NCT01812265|"~     This study will evaluate the pharmacological activity of PF-06305591 in healthy male~     volunteers by assessing the effects of two dose levels of PF-06305591 on cold pain intensity~     evoked by keeping non-dominant hand into a water bath kept at 2+/- degrees.~   "
134083|NCT01812252|"~     This randomized clinical trial studies different chemotherapies in treating patients with~     myelodysplastic syndrome before donor stem cell transplant. Giving chemotherapy before a~     donor stem cell transplant helps stop the growth of cancer cells in the bone marrow,~     including normal blood-forming cells (stem cells) and cancer cells, and may prevent the~     myelodysplastic syndrome from coming back after the transplant. When the healthy stem cells~     from a donor are infused into the patient they may help the patient's bone marrow make stem~     cells, red blood cells, white blood cells, and platelets.~   "
134084|NCT01812239|"~     A Multicenter, Double-Blind, Placebo-Controlled Randomized Clinical Trial of Vaginal~     Progesterone to Prevent Early Preterm Birth In Twin Pregnancy with Short Cervix.~   "
134088|NCT01812187|"~     The purpose of this study is to increase access for rural Veterans to evidence-based,~     person-centered, individually tailored treatment for alcohol use problems. The primary aim is~     to evaluate the acceptability and feasibility of using mobile technology deliver treatment~     for alcohol use disorder. A mobile application will be used replacing the usual setting of~     clinical visits that accompanies standard face-to-face CBT therapy. The application will be~     loaded onto an iPod, which will be distributed to each participant that has been found to be~     eligible to participate.~   "
134096|NCT01812083|"~     The investigators hypothesized that the IL-1A (+4895), IL-1B (+3954), and IL-1RN gene~     polymorphisms may be associated with PLBW. Smoking has been well documented by numerous~     studies as a major environmental risk factor for periodontitis and adverse pregnancy~     outcomes. Therefore, the investigators only selected non-smoking individuals in this study as~     the smoking-related risk could obscure the polymorphism-related increase in risk for~     periodontitis and adverse pregnancy outcomes. This study aimed to determine the association~     between IL-1A (+4895), IL-1B (+3954), and IL-1RN polymorphisms with adverse pregnancy~     outcomes and periodontitis in a non-smoking Turkish population.~   "
134097|NCT01812070|"~     This innovative study will compare a newly developed smartphone application for Acceptance~     and Commitment Therapy (ACT) to a smartphone application for traditional cognitive behavioral~     therapy (CBT).~   "
134098|NCT01812057|"~     The purpose of this study is to compare post-cesarean section consumption of pain medication~     between two groups of patients undergoing scheduled cesarean section at term gestation who~     receive a single-dose of intraoperative steroid (dexamethasone 8 milligrams) versus placebo~     at 24 hours after surgery. The hypothesis is that a single perioperative dose of~     dexamethasone 8 mg will significantly reduce postoperative opioid consumption at 24 h in~     women having cesarean delivery under spinal anesthesia.~   "
134099|NCT01812044|"~     The purpose of this study is to determine if local anesthetic, either a subtenons injection~     (an injection just beneath the surface tissue of the eye) or a topical ophthalmic gel~     (applied directly on the surface of the eye) given at the end of strabismus surgery reduces~     postoperative pain. Some surgeons routinely use either the subtenon and/or topical anesthetic~     for pain at the end of strabismus surgery.~   "
134100|NCT01812031|"~     Fluorodeoxyglucose (FDG) positron emission tomography (PET) is now widely used for cancer~     imaging purpose, notably for preoperative work-up. It aims at visualizing organs metabolism.~     In case of cancer, metabolism is, classically, increased and some hot spots are visible on~     PET images. Because of respiratory motion some lung tumours (especially the smallest ones)~     can be falsely interpreted by the clinician.~      The investigators developed a respiratory-gated PET method in order to reduce the motion~     issue. The investigators designed a study to investigate its effect on lung cancer (primary~     or metastasis) to check if it improves the sensitivity/specificity of PET imaging of the~     lungs.~      To that aim, patients presenting a lung nodule on a CT examination can be proposed to~     participate this study. After the standard PET acquisition (acquired in free-breathing), an~     additional 10 minutes respiratory-gated PET acquisition is performed without additional~     injection. After that, a breath-hold (~10s) CT is performed.~   "
134101|NCT01812018|"~     The purpose of this exploratory phase II study is to assess the effectiveness and safety~     profile of Endostar®(Recombinant Human Endostatin Injection) plus Gemcitabine and Docetaxel~     in treatment of soft tissue sarcoma patients with pulmonary metastases.~   "
134102|NCT01812005|"~     This phase II trial studies how well alisertib with and without rituximab works in treating~     patients with relapsed or refractory B-cell non-Hodgkin lymphoma. Alisertib may stop the~     growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal~     antibodies, such as rituximab, can block cancer growth in different ways. Some block the~     ability of cancer cells to grow and spread. Others find cancer cells and help kill them or~     carry cancer-killing substances to them. Giving alisertib with and without rituximab may be~     an effective treatment for B-cell non-Hodgkin lymphoma~   "
134103|NCT01811992|"~     Despite the marginal improvements in survival of patients suffering from malignant glioma~     treated with gene therapy vectors, the clinical trials conducted so far using viral vectors,~     in particular adenoviral vectors, have proven that the use of adenoviral vectors is a safe~     therapeutic approach, even in large, multicenter, phase 3 clinical trials. Treatment of~     malignant glioma using gene transfer modalities typically consists of surgical debulking of~     the tumor mass followed by the administration of the viral vectors into the brain tissue~     surrounding the tumor cavity. This study will combine direct tumor cell killing (TK) and~     immune-mediated stimulatory (Flt3L) gene transfer approaches delivered by first generation~     adenoviral vectors.~   "
134104|NCT01811979|"~     Oral sucrose reduces pain during heel sticks and venipunctures in preterm infants. The~     purpose of this study was to determine the effectiveness of local anesthetic eye drops and a~     pacifier, plus repeated doses of 24% sucrose, to relieve pain associated with eye~     examinations for retinopathy of prematurity.~   "
134105|NCT01811966|"~     Preoperative fasting can evoke a hypovolemia which may cause a hemodynamic instability during~     introduction of anesthesia.~      The purpose of this study is to test the hypothesis that a defined preoperative volume~     substitution compared to standard procedure will result in a reduced incidence of hemodynamic~     instabilities during introduction of anesthesia in elective surgery patients.~   "
134106|NCT01811953|"~     Bioequivalence of an empagliflozin/metformin (FDC) tablet compared with single tablets of two~     strength of empagliflozin and metformin (Part I) under fasted and under fed conditions and~     bioequivalence of empagliflozin/metformin (FDC) tablet compared with single tablets~     empagliflozin and metformin under fed conditions (Part II).~   "
134107|NCT01811940|"~     The proposed protocol is a multi-site double-blind, placebo-controlled outpatient study of~     the safety and efficacy of Adderall-XR (MAS-ER) and topiramate in the treatment of cocaine~     dependence. 198 patients will be enrolled and 176 patients randomized in a 14-week trial. The~     proportion of participants achieving sustained cocaine abstinence for three consecutive weeks~     at the end of the study will be significantly greater for the combined pharmacotherapies~     group compared to the placebo group.~   "
134108|NCT01811927|"~     The purpose of this study is to the assess the clinical performance of the BIOTRONIK~     PRO-Kinetic Energy stent in subjects with atherosclerotic disease of native coronary~     arteries.~   "
134109|NCT01811914|"~     Focused transthoracic echocardiography (TTE) is a technique, which allows quick and~     non-invasive diagnosis and monitoring in hemodynamic instable patients. There are preliminary~     data supporting the hypothesis that TTE is feasible in the operating theatre.~      The purpose of this study is to test the hypothesis that intraoperative focused TTE has an~     impact on high risk patients´ management when it is added to standard extended monitoring~     practices in hemodynamic instabilities.~   "
134875|NCT01801904|"~     The purpose of this study is to assess if panitumumab is active enough to warrant comparative~     studies in patients with metastatic colorectal cancer that has progressed after treatment~     with cetuximab.~   "
134111|NCT01811888|"~     This is a prospective, observational study, aimed to establish the relationship between an~     inefficient endogenous pain modulation before surgery (total knee arthroplasty; TKA) and the~     probability to develop chronic pain after surgery (persistent post surgical pain). Endogenous~     analgesia efficiency will be measured during the month previous to surgery using quantitative~     sensory testing (QST). Persistent post surgical pain will be defined as presence of pain in~     movement greater than 3 points in a 0-10 numerical scale in the operated knee, 6 months after~     surgery.~   "
134112|NCT01811875|"~     Primary objective: To assess post-marketing immunogenicity of Optivate® by monitoring plasma~     inhibitor levels for at least 100 Exposure Days (EDs) for each subject.~      Secondary objectives: To assess efficacy and tolerability by monitoring FVIII recovery and~     adverse events~   "
134113|NCT01811862|"~     This is a prospective randomized controlled trial to obtain preliminary data for the design~     of a future definitive efficacy study. A randomized controlled trial is needed because~     comparison to historical data would be biased. The investigators will use sham acupuncture as~     the control to account for effect from attention from and interaction with the therapist.~   "
134114|NCT01811849|"~     A Double-blind Study of the Pharmacokinetic Properties of BIOD-238 and BIOD-250 Compared to~     Humalog® in Subjects with Type 1 Diabetes~   "
134115|NCT01811836|"~     Broad - to examine the result of feeding RS to 3-5 year old rural Malawian children on zinc~     homeostasis and environmental enteropathy (EE).~      Specific -~        1. To measure zinc status using a dual zinc stable isotope assay before and after~          administering resistant starch (RS) in 20 children.~        2. To measure intestinal function using a site-specific sugar absorption test before and~          after administering RS in 20 children.~        3. To determine the relationship between RS and zinc homeostasis.~        4. To determine the relationship between RS and environmental enteropathy.~   "
134116|NCT01811823|"~     Prospective, open-labelled study which will enrol 360 participants in four groups of 80~     participants including: HIV-uninfected adults without evidence of TB; HIV-infected adults~     without any evidence of TB; HIV-uninfected adults with concurrent microbiologic confirmed TB,~     HIV-infected adults with concurrent microbiologic confirmed TB.~      Participants will receive the recommended seasonal 2013 un-adjuvanted Trivalent Influenza~     Vaccine (TIV). At 3 visits, blood will be collected for determination of immune responses.~      Objective:~      • To determine the effect of HIV-infection, tuberculosis (TB) and HIV-TB co-infection on~     immune responses~   "
134117|NCT01811810|"~     The most common treatment for men with high risk prostate cancer is radiation therapy (XRT)~     followed by long term androgen deprivation therapy (ADT). Long-term AD is toxic, with~     substantial metabolic, physical, mental and sexual side-effects. In this study, the~     investigators propose a treatment strategy to optimize the control of high risk prostate~     cancer by using dose-escalated external beam radiation (proton therapy or IMRT) concurrent~     with docetaxel and adjuvant short-course AD. The investigators hypothesize that this approach~     will be superior to the current standard of care and obviate the need for long term AD. In~     this study, subjects will be randomized to either XRT with long term ADT or XRT and~     chemotherapy and short term ADT.~   "
134118|NCT01811797|"~     This is a prospective, randomized, double-blind clinical study comparing safety and efficacy~     of the treatments performed with the Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT)~     device - Renova on symptomatic ED patients to the safety and efficacy of the control sham~     patients.~   "
134119|NCT01811784|"~     Several human Nipah virus (NiV) outbreaks have occurred in Bangladesh since 2001with 71% case~     fatality. Outbreak investigations have repeatedly identified drinking fresh date palm sap as~     a risk factor for NiV transmission. Bats are the reservoir of NiV and infected bats can shed~     virus through both saliva and urine and can contaminate the raw sap. The virus can transmit~     to humans through ingestion of contaminated sap. To interrupt bats access to the sap, sap~     harvesters (gachhis) occasionally use skirts make by local materials. These skirts have been~     found to be effective to interrupt bats' access to the sap. As an indirect effect of the~     community level skirt promotion, some people stopped drinking raw sap. When trees have~     skirts, bats cannot access the sap and when people do not drink sap, they are at much lower~     risk of contracting Nipah virus. The purpose of this study is to design, implement and~     evaluate behavior change interventions to prevent human consumption of NiV contaminated sap~     through reducing raw sap consumption from unprotected trees in a district of the NiV affected~     regions in Bangladesh.~   "
134120|NCT01811771|"~     Background:~      Vibrio cholerae is one of the major causes of severe diarrheal disease in Bangladesh. It is~     estimated that there are about 450,000 cholera cases each year in Bangladesh. Cholera is~     prevalent in both urban and rural settings in the country. Policy decisions about how best a~     new public health tool can be incorporated into the system requires evidence. Investigators~     have recently carried out a feasibility study of oral cholera vaccine in urban Dhaka in~     Mirpur (Protocol #10061). However, whether a similar system can also be utilized in a rural~     area in Bangladesh needs to be studied.~      The hospital disease surveillance data from International Centre for Diarrhoeal Disease~     Research, Bangladesh (icddr,b) reveals a substantial burden of cholera from Keraniganj~     upazila. Investigators propose a feasibility study of oral cholera vaccination by using the~     existing national immunization service delivery mechanism in Keraniganj. This study will help~     to provide evidence for the policy makers in introducing oral cholera vaccine in preventing~     cholera in high risk rural areas in Bangladesh.~      Hypothesis:~      That icddr,b in collaboration with the Government of Bangladesh will be able to implement an~     oral cholera vaccine program that;~        1. reaches residents of rural union of Keraniganj~        2. reduces the incidence of diarrhea due to Vibrio cholerae~      Objectives:~        1. Carry out cholera vaccination in one rural union in Keraniganj.~        2. Evaluate the impact of vaccination in reducing cholera in the study area~      Methods:~      Two unions in Keraniganj will be selected; around 30,000 individuals in one union will be~     vaccinated and impact evaluated by comparison with another similar union. After vaccination,~     passive cholera surveillance at the Upazila hospital will be conducted for two years on the~     patients from the two unions.~      Outcome measures/variables:~      Cholera vaccination programme will be assessed by the number of doses administered, drop-out~     rates between the two rounds, the proportion of vaccine wastage, and the vaccine coverage.~      Proportion of diarrheal hospitalizations that are due to V. cholerae O1 between the~     vaccinated and non vaccinated union will be calculated and compared to assess the impact of~     intervention.~   "
134121|NCT01811758|"~     The investigators expect that a culturally specific group intervention targeting African~     American smokers will result in greater smoking cessation rates compared to a standard~     intervention.~   "
134194|NCT01810809|"~     Intraarticular injections have long been used to treat osteoarthritis. Viscosupplementation~     is a relatively new approach comprising the injection of hyaluronic acid into diarthrodial~     joints. The dosis regimen is well established for the knee joint, but there is still no~     consensus regarding the optimal dosage for hip viscosupplementation. Our objective is to~     determine the optimal dosis for hip viscosupplementation~   "
134122|NCT01811745|"~     The purpose of this study is to evaluate the efficacy and the possible mechanisms underlying~     music-based multitask training (i.e., Jaques-Dalcroze eurhythmics) in older people, compared~     to multicomponent exercise training.~      This study is designed as a 12-month, prospective, single-centre, single-blind, 2-arm,~     parallel group, randomized controlled trial in which 140 community-dwelling older adults at~     high risk of falls are randomly assigned to receive either a music-based multitask training~     intervention (i.e., Jaques-Dalcroze eurhythmics) or a multicomponent exercise training~     intervention, for 12 months. A 12-month follow-up is planned with outcome measures assessed~     at three time points: baseline (before intervention initiation), 6-month (intervention~     mid-point), and 12-month (intervention termination). Outcomes of interest include physical~     and cognitive performances, and falls. In addition, the investigators specifically address~     brain circuits in an exploratory sub-study. Volunteer trial participants from both study arms~     are invited to undergo functional magnetic resonance imaging (fMRI) at baseline and 12-month.~   "
134123|NCT01811732|"~     This study was designed to evaluate the efficacy of delafloxacin patients with acute~     bacterial skin and soft tissue infections (ABSSSI).~   "
134124|NCT01811719|"~     An Enhanced Nurse Home Visitation Program To Prevent Intimate Partner Violence; This~     randomized trial of an intervention to assess and prevent intimate partner violence during~     pregnancy and the post-partum builds upon the David Olds model of nurse home visitation~     (Nurse Family Partnership or NFP) for high risk mothers and infants that has shown to be~     effective in multiple settings in preventing child abuse and enhancing maternal and child~     health and psychosocial outcomes. However, prior research has shown that the NFP intervention~     is not as effective in homes where there is intimate partner violence (IPV). Although the NFP~     by itself has reduced IPV in one setting, it has not in another. The proposed study will test~     the efficacy of an enhanced NFP intervention, the ECI or Enhanced Choice Intervention among~     women referred to an existing NFP program in Portland, Oregon. The ECI is based on a choice~     or empowerment model whereby women can choose among interventions related to her goal for her~     current intimate relationship. If IPV or emotional abuse or controlling behaviors are~     assessed, the intervention is based on two interventions shown to be effective in assessing~     for and reducing repeat IPV (the Sullivan Advocacy Intervention and the McFarlane and Parker~     brochure driven intervention). For women desiring to enhance marital quality, the Markman and~     Stanley PREP model that has been shown to enhance relationship quality will be offered. The~     PREP model also has some preliminary evidence of preventing IPV. For women with other risk~     factors for IPV in their own or their partners' history (e.g. exposure to parental IPV, child~     abuse, substance abuse), community resource linkage (beyond referral) strategies as with the~     NFP model will be used to obtain community resources to address these risk factors. 250 women~     referred to the Multnomah County Health Department will be randomized to the experimental~     (NFP plus ECI) or control condition (NFP) and visited according to the regular NFP schedule~     during pregnancy and until the infant is 24 months old. The intervention will concentrate on~     the prenatal and immediate (first 6 months) post partum period with regular IPV, emotional~     abuse and controlling behavior assessments throughout the NFP period. Baseline and outcome~     measurement (CTS2, WEB, TPMI, depression - Edinborough, & parenting stress), will occur at 3~     months before delivery, 9 months & 21 months post-partum with multivariate MANOVA, SEM and~     growth curve analyses.~   "
134125|NCT01811706|"~     Investigators expect there will be improvement in walking speed and steadiness after taking~     Dalfampridine, thereby improving activities of daily living and enhancing social and~     occupational functions for patients with spinocerebellar ataxia.~   "
134126|NCT01811693|"~     This is an open, pilot, dose-escalation study of glyceryl trinitrate (GTN, Nitroglycerin)~     administered by paramedics in the field within 2 hours of symptom onset to 45 severely~     hypertensive stroke patients. The primary objective of the study is to evaluate the~     feasibility, safety, and physiologic efficacy of field-initiated glyceryl trinitrate in~     achieving modest reduction of blood pressure. Patients with acute stroke will be identified~     in the field by paramedics who have received training in basic and advanced cardiac life~     support, stroke recognition, and specific procedures relevant to the proposed study.~     Physician-investigators will obtain informed consent for each subject for study entry after~     cellular phone contact with paramedics. Paramedics will initiate antihypertensive treatment~     by applying transdermal GTN patch in the first two dose-tiers, and administering a single~     sublingual GTN metered spray followed by application of the transdermal system in the last~     dose tier. The sites involved in the study will be emergency medical services rescue~     ambulances and 8 receiving Stroke Center hospitals in Orange County, California, USA.~   "
134127|NCT01811680|"~     To conduct a feasibility clinical trial to test a novel patient sensing automated treadmill~     device devised by local engineers for subacute hemiplegic stroke patients for gait~     rehabilitation. This is a phase 1 feasibility and safety trial on the above device for 10~     chronic stroke patients with hemiparetic gait dysfunction to be conducted over a period of 2~     months.~      Research protocol and standardized outcomes measures will be used.~   "
134128|NCT01811667|"~     The phosphatidylinositol 3-kinase (PI3Kinase)/Protein Kinase B (AKT)/mammalian target of~     rapamycin (mTor) pathway plays a role on the development and the lymphatic-vascular~     organisations.~      The investigators want to study the efficacy and the safety of Rapamycin, an mTor inhibitor.~   "
134129|NCT01811654|"~     The purpose of this study is to determine the safety and effectiveness of intra-articular~     hyaluronan (IAHA) injections for the treatment of symptomatic patellofemoral pain syndrome~     (PFPS) and determine if this treatment can provide incremental clinical benefits over~     standard care for patients with this diagnosis.~   "
134130|NCT01811641|"~     Accumulating evidence suggests that early-life nutrition can affect metabolism and thus~     increase the risk of disease in adulthood (e.g. type II diabetes and obesity). One possible~     mechanism to explain these effects is epigenetic variation at critical periods of~     development. Epigenetic variation describes non-inherited permanent alterations to an~     individuals DNA.~      Recent work in mouse models has demonstrated that maternal nutritional status can affect such~     epigenetic processes such as DNA methylation and gene expression during embryonic~     development, with profound effects on outcomes. The investigators aim to study these~     processes in humans for the first time. The investigators will exploit the experiment of~     nature setting in The Gambia, i.e. fluctuation in diet according to season. During the~     'hungry' season diets are known to be depleted in nutrients required for epigenetic gene~     regulation. Nutritional biomarkers in blood as well as the dietary intake will be measured in~     pregnant women according to season. A blood sample will also be taken from babies born to~     these women to determine whether there is a direct effect of diet on mothers' nutritional~     status and hence variation in DNA methylation patterns in their babies by season.~   "
134131|NCT01811628|"~     The goal of this research study is to collect information from Latino and Hispanic smokers~     and recent quitters about factors that are important to them when they are trying to quit.~     Researchers want to better understand some of the challenges and problems that Latinos and~     Hispanics face when they try to quit smoking, and then use that information to design a~     treatment for future smokers.~   "
134132|NCT01811615|"~     Background To evaluate the efficacy of two alcohol-free antimicrobial mouthrinses in reducing~     plaque and gingivitis compared to an alcohol-containing rinse and toothbrushing alone.~      Methods 160 healthy volunteers were enrolled in the parallel-design examiner-blind study.~     After screening and stratification by sex and papillary bleeding index (PBI), participants~     were randomly and equally assigned to four groups: (1) toothbrushing + rinsing (0.06% CHX +~     0.025% NaF, alcohol-containing rinse, Corsodyl® Daily Defence Mouthwash; positive control);~     (2) toothbrushing + rinsing (0.06% CHX + 0.025% NaF, alcohol-free experimental rinse); (3)~     toothbrushing + rinsing (0.06% CHX + 0.03% CPC + 0.025% NaF, alcohol-free experimental~     rinse); (4) toothbrushing alone (negative control). At baseline, Quigley-Hein plaque index~     (QHI), the modified proximal plaque index (MPPI), and PBI were recorded. All subjects were~     advised to brush their teeth as usual during the eight weeks study period. Additionally,~     groups 1-3 were instructed to rinse twice daily (30 sec. each). All participants used Dr.~     Best multi aktiv toothpaste and Dr. Best plus toothbrush (medium stiffness). Eight weeks~     after baseline, indices were recorded again. Anova with Bonferroni adjustment was used for~     statistical analysis.~   "
134133|NCT01811602|"~     A randomized controlled trial pilot study to test the efficacy of a pelvic muscular training~     intervention led by a physiotherapist on urinary incontinence, quality of life and sexual~     health in women who report urinary urgency and incontinence following surgery and radiation~     treatment for gynecological cancer vs. usual care (a 1-page sheet on Kegel exercises).~   "
134134|NCT01811589|"~     Failure of ventricular catheters remains a significant problem in patients with~     hydrocephalus. The purpose of this study is to determine whether the use of a simple~     instrument assisted by a smart phone application software can achieve a more precise~     placement of ventricular catheters than the standard free-hand placement technique.~   "
134135|NCT01811576|"~     The primary objective of this study is to evaluate the clinical effect of TV-1106.~   "
134136|NCT01811563|"~     The purpose of this study is to assess the differences in functional and patient reported~     outcomes between total knee replacement (TKA) implants. In addition, this work will examine~     the correlation between functional assessments and patient reported outcomes following~     surgery. All subjects will complete assessments preoperatively, 4-6 weeks following TKA and~     then one year following TKA. Subjects will complete a series of patient reported outcomes as~     well as a series of functional outcomes at each of the time points of interest. The analysis~     will include a repeated measures design to determine differences between groups across time~     as well as correlations between the functional and patient reported outcomes. This work will~     hopefully determine the importance of using objective functional outcomes following TKA as~     well as determining the need for patient assessments out to one year following surgery.~   "
134137|NCT01811550|"~     The Insights on Selected Procoagulation Markers and Outcomes in Stroke Trial (I-SPOT):~     Response to Insulin Administration and Blood Glucose Control proposal is designed to~     accompany the Stroke Hyperglycemia Insulin Network Effort (SHINE) clinical trial, a Phase III~     multicenter, randomized, controlled trial planning to determine the efficacy and validate the~     safety of glycemic control in stroke patients. The SHINE trial will recruit 1,400 AIS~     patients with Type II diabetes mellitus (T2DM) and hyperglycemia, each receiving 3 days of~     hyperglycemia control with intravenous (IV) insulin therapy or control therapy with~     subcutaneous (SQ) insulin. The I-SPOT trial will recruit 315 SHINE patients. Blood~     coagulation marker levels will be measured before and at 48 hours after the start of~     treatment. Baseline and temporal changes in biomarkers levels will be compared between~     treatment groups.~      Hypothesis: The decrease in levels of markers of blood coagulation will be greater in~     patients treated with IV insulin to reduce BG than in patients treated with SQ Insulin as the~     standard fashion.~      Hypothesis: The decrease in levels of markers of blood coagulation will be greater in~     patients with than without favorable (SHINE) outcome (defined as the baseline stroke severity~     adjusted measure of functional ability at 90 days after AIS).~      Hypothesis: Hyperglycemia control modulates the relationship between blood coagulation levels~     and functional outcome in T2DM patients after stroke. Patients treated with IV Insulin for~     hyperglycemia control with favorable (SHINE) outcome will have greater decreases in blood~     coagulation levels than either IV Insulin-treated patients without favorable outcome or SQ~     Insulin-treated with or without favorable outcomes at 90 days after AIS.~   "
134138|NCT01811537|"~     Mitral prolapse is a common cardiac disease whose patients are at higher risk for serious~     complications. Mitral valve (MV) repair offers several important advantages compared with~     valve replacement and it achieves excellent midterm and long-term results. Two major problems~     of using pre-measured expanded polytetrafluoroethylene(ePTFE) neochordae (the loop technique)~     are deciding the length of the neochordae and tying the knot at the intended length.~     Therefore, a great need still exists to find new method to simplify and precise the length of~     neochordae. 20 patients with mitral valve prolapse who undergo mitral valve repair using~     neochorda will be recruited in this study. Trans thoracic echocardiography (TTE) will be done~     preoperatively for all patients. Two, three, and four chamber view of each patient will be~     pre-operatively recorded. The device will be set with extracted measurements. Artificial~     corda loops are made using CV-4 ePTFE sutures. After artificial chordae replacement, the ring~     annuloplasty will be done. Follow up: A leakage test after attaching the 1st loop; Post~     operative trans esophageal echocardiography (TEE) and determining the severity of mitral~     regurgitation [Wall motion Score Index (WMSI), Mitral Annulus Area (MAA), LVEF, End Systolic~     Volume (ESV), End Diastolic Volume (EDV), Iso-Volemic Relaxation Time (IVRT), (IVRT/(QE-QE^')~     ,Chamber Relaxation velocity)/(Myocard relaxation velocity(E/E^' ), HR]; TEE 3 months after~     discharge; Cross clamp time; Intubation period in ICU.~   "
134150|NCT01811381|"~     Physical exercise has proven to improve memory including in the elderly. Drugs developed to~     stop the underlying disease processes that cause Alzheimer's disease may succeed only with~     multimodal efforts to stimulate brain function. One purpose of the study is to test the~     clinical benefits of curcumin, a safe and effective compound isolated from the turmeric root~     (a component of Indian curry spices), which has been found to inhibit several potential~     disease pathways in Alzheimer's disease. Another purpose of this study is to determine how~     the addition of a physical exercise program in individuals with early memory problems may~     affect memory function or brain imaging and blood-based markers associated with Alzheimer's~     disease.~   "
134139|NCT01811524|"~     The main goal of the study is to present a framework, which integrates DNA, RNA and tissue~     data to identify and prioritize genetic events that represent clinically relevant new~     therapeutic targets and prognostic biomarkers for different kinds of brain tumors. The~     investigators study the regulation of neoplastic cell growth by oncogenes, tumor-suppressor~     and other cancer related genes using modern molecular genetic methods, such as~     chromogenic-in-situ hybridization, comparative genomic hybridization (CGH), array-CGH, cDNA~     microarray etc. In these studies the investigators utilize disease-specific tissue~     microarrays (TMA) which the investigators have constructed since 1999. Until now up to 3000~     different brain tumours have been sampled to our TMA:s. These permit high-volume simultaneous~     analysis of molecular targets at the DNA, mRNA and protein levels. Research group has also~     focused its interest on the neoplastic development of gliomas, particularly on their~     hereditary and environmental factors.~   "
134140|NCT01811511|"~     The investigators performed a 12-week, randomized, double-blind, placebo-controlled crossover~     human trial to evaluate the efficacy and safety of chungkookjang on improvement of metabolic~     syndrome. The investigators measured decrement of body fat parameters, including Body Fat~     Mass, Percent Body Fat, Fat Free Mass, Weight and BMI(body mass index), and monitored their~     blood pressure.~   "
134141|NCT01811498|"~     The high-grade malignant brain tumors, glioblastoma multiforme (GBM), comprise the majority~     of all primary brain tumors in adults. This group of tumors also exhibits the most aggressive~     behavior, resulting in median overall survival of only 9-12 months. Initial therapy consists~     of either surgical resection, external beam radiation, or both. All patients experience a~     recurrence after first-line therapy, so improvements in both first-line and salvage therapy~     are critical to enhancing quality-of-life and prolonging survival. It is unknown if currently~     used intravenous (IV) therapies even cross the blood brain barrier (BBB). We have shown in a~     previous phase I trial that a single Superselective Intraarterial Cerebral Infusion (SIACI)~     of Bevacizumab (up to 15mg/kg) is safe and effective in the treatment of recurrent GBM.~     Therefore, this phase I/II clinical research trial is an extension of that trial in that we~     seek to test the hypothesis that repeated dosing of intra-arterial Bevacizumab is safe and~     effective in the treatment of newly diagnosed malignant glioma. By achieving the aims of this~     study we will also determine if repeated intra-arterial Bevacizumab improves progression free~     and overall survival in newly diagnosed patients. We expect that this project will provide~     important information regarding the utility of repeated SIACI Bevacizumab therapy for~     malignant glioma, and may alter the way these drugs are delivered to our patients in the near~     future.~   "
134142|NCT01811485|"~     The purpose of the study was to evaluate the efficacy and safety of LMF237 50/250 mg and~     50/500 mg bid in Japanese patients with T2DM inadequately controlled with vildagliptin~     monotherapy. This study was conducted to support registration of the fixed-dose combination~     of vildagliptin and metformin for the treatment of T2DM in Japan.~   "
134143|NCT01811472|"~     The purpose of this study was to determine whether LCQ908 effectively lowers liver fat, as~     assessed by MRI and to assess its safety and tolerability profile in subjects with~     non-alcoholic fatty liver disease (NAFLD).~   "
134144|NCT01811459|"~     Background:~      Delirium is an important problem in critical care. Its prevalence often reaches 75% in~     intensive care patients. Its occurrence is associated with numerous complications and~     deleterious consequences such as death, longer stay, higher cost, and long-term cognitive~     impairment. Delirium treatment entails correcting its underlying causes and usually~     initiating a pharmacological intervention with an antipsychotic. Typical antipsychotics,~     particularly haloperidol, are commonly used to treat delirium although few placebo-controlled~     trials of pharmacological treatments for delirium have been conducted. Furthermore,~     appropriate doses for delirium treatment have yet to be established. In critical care, two~     pilot studies provided the first randomized, placebo-controlled evidence for the~     pharmacologic treatment of ICU delirium. One found that neither haloperidol nor ziprasidone~     significantly reduced the incidence or duration of delirium compared with placebo whereas the~     other one found that quetiapine added to as-needed haloperidol resulted in faster delirium~     resolution.~      Objective:~      The goal of this study is to determine the effectiveness of antipsychotics in regular dosage~     regimen (quetiapine group and haloperidol group) compared to as-needed haloperidol (placebo~     group) in the pharmacological treatment of delirium. We will conduct a three-arm randomized~     controlled trial to achieve this goal.~      Materials and Methods:~      During one year, 45 delirious patients from three intensive care units will be recruited and~     randomized into one of three groups. Randomization will be performed in blocks of 9 by the~     pharmacy department, using a random numbers table.~      Patients will be continuously screened for delirium using the Intensive Care Delirium~     Screening Checklist (ICDSC) as part of routine care. A positive screening score (≥4) will~     warrant confirmation of delirium diagnosis by the treating physician. Treatment will begin~     according to randomization group, provided that informed consent has been obtained. Delirium~     status will be monitored during the episode using the Nursing Delirium Screening Scale~     (Nu-DESC). When the Nu-DESC monitoring will become negative for delirium (total score below~     2), the resolution of the episode will be confirmed by the treating physician. A clinical~     evaluation by a psychiatrist will be performed within 24-48 hours of each of the two~     evaluations made by the treating physician (beginning and end of the delirium episode).~      The treating physician will initiate twice-daily treatment at the first of five levels for~     each of the three groups: 1) 1 mg of intravenous (IV) haloperidol + oral (PO) placebo, 2) 50~     mg of PO quetiapine + IV placebo, or 3) IV + PO placebo. Therapy will be titrated upwards on~     a daily basis by increments of 1) 1 mg of IV haloperidol or 2) 50 mg of PO quetiapine, or 3)~     IV + PO placebo every 12 hrs, respectively, if the subject received at least two doses of~     as-needed haloperidol in the previous 24 hrs. As-needed (PRN) doses of 2 mg of IV haloperidol~     q 30 minutes will be available to patients from all three groups and administered by nurses~     until symptoms associated with delirium resolve. In case of unsuccessful as-needed treatment,~     rescue (STAT) doses of 5 mg of IV haloperidol q 30 minutes will be available to patients from~     all three groups and will be administered by nurses if agreement is reached with the treating~     physician that the situation indeed calls for it. The treatment level of patients requiring a~     STAT dose will immediately be raised to the above level. The treatment will stop when one of~     the following occurs: (1) the subject is deemed by the treating physicians, based on their~     clinical judgment, to no longer demonstrate signs of delirium and, therefore, to no longer~     require scheduled therapy with an antipsychotic agent; (2) 21 days of therapy has elapsed;~     (3) ICU discharge occurred; or (4) a life-threatening adverse event potentially attributable~     to the study drug occurred that warranted discontinuation of the study drug.~      Adverse effects will be closely monitored: extrapyramidal reactions, neuroleptic malignant~     syndrome, drowsiness, hypotension, QTc prolongation. The treatment level of patients~     presenting a non life-threatening adverse event will immediately be lowered to the level~     directly below.~      The sample size was calculated for a 2-tailed test with an alpha of .05 and a power of .80.~      The primary statistical analysis will involve Cox proportional time to event analysis~     comparing the three groups. Secondary analysis will use T-test comparisons for continuous~     variables and chi square for proportional analysis.~   "
134145|NCT01811446|"~     The purpose of this study is to determine whether muscle activation can be accomplished more~     effectively and comfortably in challenging subjects using novel configurations of an~     activation device. A novel device will be compared side by side with a market leading device.~   "
134146|NCT01811433|"~     The purpose of this study is to determine whether the Halo Index has utility in detecting the~     difference between normal and non-normal recovery of patients in the first few hours~     immediately following major inpatient surgery. A small but significant percentage of patients~     who undergo major surgery will experience a major life-threatening complication in the first~     30 days following surgery.~      The chance of developing one or more of these complications increases with the size of the~     surgery and with the severity of the patient's preexisting medical problems. It is unknown~     whether fluctuations in a patient's vital signs and other measures of bodily function that~     occur early in the recovery period are associated with postoperative complications. If this~     is so, it may be possible to predict who is at increased risk for complications based on~     monitoring during the early recovery period.~      This study will make use of the Halo Index, a compilation of measures of patient functions~     collected by non-invasive monitoring devices. In addition to heart rate, blood pressure,~     temperature, and breathing rate, these include measures of dissolved oxygen in the blood, the~     amount of hemoglobin in the blood, and other parameters.~      Patients will have two additional non-invasive monitors attached during their stay in the~     hospital post-anesthesia care unit (PACU). After the patient has been discharged from the~     hospital, their medical record will be reviewed at two time points: The first will be soon~     after discharge. Normal recovery patients will be defined as those who require only IV~     fluids, pain medications and anti-emetic medications. Non-normal recovery will include those~     who require transfusions of blood products, airway interventions such as a breathing tube,~     blood pressure medications, or heart rhythm medications. The second chart review will occur~     30 days after surgery. In this review, the presence or absence of the following events will~     be ascertained: rapid response team calls, admission to the intensive care unit, infection,~     pneumonia, the need for transfusion of 5 or more units of blood within a three-day period,~     septic shock, the need for ventilation with a breathing tube, blood clot in the lung, kidney~     failure, coma, stroke, heart attack, and death.~   "
134147|NCT01811420|"~     To evaluate the efficacy of a papain-based gel in caries removal.~   "
134148|NCT01811407|"~     Physical activity is known to help reduce obesity and the problems that accompany it. Walking~     has many benefits that make it an excellent way for obese people to increase their physical~     activity. It is hard, however, for people to stick with walking programs. Setting specific~     and challenging walking targets that are combined with timely feedback about discrepancies~     between desired and actual performance lead to higher performance. There is conflicting~     theory and evidence about the effects of publicly announcing those targets on commitment to~     the targets and on performance.~      Our research question is whether public announcements reduce the challenge level of~     commitments people set, and whether the reputational consequence of public announcements is~     severe enough to increase performance. The investigators propose a controlled trial that will~     integrate Facebook with the objective monitoring of walking via the use of pedometers to test~     the effect of public announcements on commitments and step counts.~      All participants will wear a pedometer and upload via the internet for 14 to 15 weeks,~     depending on their date of randomization. The first 2 to 3 weeks the investigators will~     determine the participant's baseline step counts. The following 12 weeks, the investigators~     will recommend a daily step count target based on the median number of steps the participants~     walked the previous week. Each week, participants will set a commitment by stating the number~     of days in the following week that he/she will meet the computer-set step count target.~      Commitments will be entered into an interface that will link with Facebook. Participants will~     select who of their Facebook friends will receive their commitments and/or results via~     Facebook posts. The interface will distribute those posts in a way that fits in with existing~     online social practices.~      There will be 3 experimental conditions. 1.) No public announcements 2.) Public announcement~     of commitment and 3.) Public announcement of commitment and results. In addition, groups 2~     and 3 will provide us with emails of 3 friends or family members who will act as the~     participant's support team. The investigators will send announcements directly to support~     team members.~      The investigators plan to recruit 165 participants primarily by obtaining lists of~     potentially eligible University of Michigan Health System patients from the clinical data~     repository, and sending targeted letters to these patients. Because this research - and the~     physical activity programs it will inform - aims to reach a large number of people~     efficiently, enrollment will take place online with a click-through consent document. The~     investigators have extensive experience with delivering online walking programs in similar~     populations.~      The investigators hope to learn best practices for using public announcements and online~     social networks to encourage people to exercise more or to otherwise promote wellness.~   "
134151|NCT01811368|"~     This phase II trial studies how well ibritumomab tiuxetan before donor peripheral blood stem~     cell transplant works in treating patients with relapsed or refractory non-Hodgkin lymphoma.~     Giving rituximab, antithymocyte globulin, and total-lymphoid irradiation (TLI) before a donor~     peripheral blood stem cell transplant helps stop the growth of cancer cells and helps stop~     the patient's immune system from rejecting the donor's stem cells. Also, radiolabeled~     monoclonal antibodies, such as ibritumomab tiuxetan, can find cancer cells and carry~     cancer-killing substances to them without harming normal cells. When the healthy stem cells~     from a donor are infused into the patient they may help the patient's bone marrow make stem~     cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells~     from a donor can make an immune response against the body's normal cells. Giving rituximab,~     antithymocyte globulin, and TLI before the transplant together with cyclosporine and~     mycophenolate mofetil after the transplant may stop this from happening. Giving a~     radiolabeled monoclonal antibody before a donor peripheral blood stem cell transplant may be~     an effective treatment for non-Hodgkin lymphoma.~   "
134152|NCT01811355|"~     The purpose of this study is to determine if mexiletine is effective for the treatment of~     muscle cramps in Amyotrophic Lateral Sclerosis (ALS).~   "
134153|NCT01811342|"~     Evaluate potential sources of error that affect the accuracy of continuous hemoglobin~     monitoring.~   "
134154|NCT01811329|"~     Phase 1 of this study involves determining how consumption of dairy fat fractions rich in~     milk fat globule membrane influences postprandial inflammation in participants with metabolic~     syndrome or obesity during a high dietary fat challenge in a six-hour period.~   "
134155|NCT01811316|"~     The purpose of this study is to evaluate the long-term efficacy and safety of lozenges~     containing probiotics in reducing gingivitis. The primary purpose of this study is to support~     claims from U.S. instructions for use (IFU) for GUM® PerioBalance®.~   "
134156|NCT01811303|"~     The purpose of this study is to determine whether D-fagomine affects glycaemic responses to~     sucrose (commercial white sugar)and quantify the response~   "
134157|NCT01811290|"~     The purpose of this study is to assess whether Multiple Sclerosis patients treated with~     Gilenya show a beneficial change over time in bone mass density and bone turnover markers as~     compared to matched controls treated with alternative FDA approved therapy or no therapy.~   "
134158|NCT01811277|"~     This is an exploratory, single-armed, open label study on the efficacy and safety of~     sequential S-1 therapy after SOX in unresectable metastatic or locally advanced biliary~     system or periampullary cancer or pancreatic cancer patients. The primary endpoint is~     Objective response rate and secondary endpoint is progression free survival , overall~     survival ,1 year survival rate and safety.~   "
134159|NCT01811264|"~     Through a patient participation aid (PPA) the investigators hope to improve the psychosocial~     well-being of women diagnosed with metastatic breast cancer by empowering them to be active~     participants in clinical encounters.~   "
134160|NCT01811251|"~     The aim of the study is to show a decrease in postoperative pain during the first~     postoperative mobilization surgery lumbar disc herniation through a co-analgesia with a~     single dose of dexamethasone, pregabalin, or a combination of these two products.~      Pain assessed by simple numerical scale will be also evaluated during the 48 first~     post-operative hours.~      Determining an optimal co-analgesic protocol through the results of this study could help~     develop validation studies with larger scale such as a medico-economic component. In~     addition, these study protocols are easy to apply (ponctual administration) and inexpensive.~   "
134161|NCT01811238|"~     Study Objectives:~        1. Primary objective~           - To assess the pain reduction after 8 weeks treatment from baseline (week 0)~        2. Secondary objectives~             -  To assess the pain reduction after 4 weeks treatment from baseline (week 0)~             -  To assess the EQ-5D~             -  To assess physician's overall satisfaction~             -  To assess subject's overall satisfaction~             -  To assess safety~   "
134162|NCT01811225|"~     Using two clinical models - pregnancy (Sample 1) and oral contraceptives (OC; Sample 2) - we~     aim to (1) examine the association between levels of progesterone (Prog), allopregnanolone~     (Allo) and the estradiol/progesterone (E2/P) ratios with smoking-related symptomatology~     during ad libitum smoking, and (2) determine the association between Prog, Allo, and E2/P~     with the changes in smoking-related symptomatology and response to nicotine following~     overnight abstinence~   "
134163|NCT01811212|"~     This phase II trial studies how well cabozantinib-s-malate works in treating patients with~     thyroid cancer that does not respond to treatment. Cabozantinib-s-malate may stop the growth~     of thyroid cancer by blocking some of the enzymes needed for cell growth.~     Cabozantinib-s-malate may also stop the growth of thyroid cancer by blocking blood flow to~     the tumor.~   "
134164|NCT01811199|"~     Hypothesis: Dexamethasone reduces postoperative emesis in thyroidectomy and mastectomy~     patients.~   "
134165|NCT01811186|"~     Objectives:~        1. Objective of main interest~           - To assess the drop-out rate caused by adverse event* after 6 weeks treatment~        2. Further objectives~             -  To assess the drop-out rate caused by adverse event* after 1 week treatment~             -  To assess the pain reduction rate after 6 weeks treatment from baseline~             -  To assess the Euroquol (EQ-5D) quality of life~             -  To assess physician's overall satisfaction~             -  To assess subject's overall satisfaction~             -  To assess safety~   "
134166|NCT01811173|"~     This study is intended to examine whether directed care of a nurse working jointly with the~     patient's primary care physician, including a comprehensive assessment, creation of a~     tailored care plan, proactive follow-up, self management support and caregiver support and~     care coordination, can reduce hospital admissions for patients with multiple chronic~     conditions.~   "
134176|NCT01811043|"~     The goal of this study is to examine whether a guided meditation intervention will reduce~     anxiety and distress as compared to a music intervention or radiologist supportive dialogue~     in women undergoing imaging-guided core needle breast biopsies. Both the guided meditation~     and music interventions are administered through use of headphones during routine outpatient~     imaging-guided core needle breast biopsies. Women in the guided meditation and music~     conditions will be given a CD with instructions for home practice. Women complete follow-up~     questionnaires in the 12 months after biopsy. Receipt of recommended follow-up care is~     examined for 60 months.~   "
134177|NCT01811030|"~     Evaluate the safety and efficacy of removing unwanted scars using a 755nm Alexandrite laser.~   "
134167|NCT01811160|"~     Schizophrenia and bipolar disorder are frequently associated with an elevated risk for~     obesity, metabolic syndrome, diabetes mellitus, dyslipidemia and other metabolic~     disturbances. Second Generation Antipsychotics (SGA) have a demonstrated efficacy in acute~     and long term treatment of these disorders and are considered a first option on most~     treatment guidelines. Unfortunately the use of SGA is associated to drug induced weight gain,~     disturbed glucose and lipid regulation and an increase of cardiovascular risk and mortality~     as well as non- adherence to treatment. There are several hypotheses attempting to explain~     the complex pathways that lead to antipsychotic therapeutic effects and their accompanying~     adverse effects. Recently, in animals receiving SGA, melatonin prevented to a large extent~     the body weight increase, which indicates a possible role for biological rhythms in SGA~     induced body weight accumulation. Melatonin is a hormone secreted by the pineal gland that~     follows a circadian rhythm with an increased secretion in the middle of the night. This~     hormone acts importantly on the suprachiasmatic nucleus and other areas in the brain and~     periphery. Thus melatonin is involved in a series of biological functions such as sleep~     regulation, blood pressure, regulation of circadian rhythms, mood, behavior, and more~     recently in the regulation of metabolic processes including insulin, leptin, and lipid~     regulation.~      Given previous results in experimental animals, the purpose of the present study is to test~     the potential effect of melatonin in reducing or preventing some of the metabolic~     disturbances associated with SGA~   "
134168|NCT01811147|"~     The purpose of the study is to find out what parts of the brain have increased or decreased~     activity and connectivity in individuals who have bipolar disorder, major depression, or no~     history of mood disorder. Another purpose of this study is to use MRI images to determine~     which young adults with major depression may be at greater risk for developing mild or more~     severe symptoms of mania which suggests a diagnosis of bipolar disorder.~   "
134169|NCT01811134|"~     Unruptured saccular intracranial aneurysms larger than 7 mm can be treated with endovascular~     occlusion using detachable coils, with or without expendable stent assistance. A new~     endovascular technique has recently been developed, using flow diverter stents without~     associated coils. Clinical results already published are encouraging but have to be~     confirmed. Furthermore, these medical devices are expensive in comparison to the coiling~     strategy. The purpose of this study is to compare the clinical efficacy, safety, and~     cost-effectiveness of endovascular coiling and endovascular flow diversion for unrupted~     saccular intracranial aneurysms.~   "
134170|NCT01811121|"~     Glioblastoma is the most frequent primary malignant brain tumor in adults (3,000 new cases~     per year) and is characterized by a poor prognosis (median survival 12 months). Treatment is~     based mainly on surgical excision as complete as possible followed by an additional~     radiochemotherapy. The prognosis depends mainly on the quality of resection when it is~     macroscopically complete. Different techniques to support the surgical resection have been~     developed over the past 20 years. The reference technique is currently the intraoperative~     neuronavigation for guiding excision by matching the intraoperative tumor boundaries with~     those of the preoperative MRI. Its main drawback is the loss of precision during the~     resection related to changes in anatomical limits of the tumor.~      The per-operative fluorescence-guided surgery (FGS) is an innovative alternative technique to~     support the surgical resection. The 5-aminolevulinic acid (5-ALA), a molecule absorbed by the~     patient before surgery is captured specifically by the tumor cells and transformed into a~     fluorochrome revealed intraoperatively by a light source length adapted wave with a set of~     lenses included in the microscope. Resection is thus guided by this fluorescence whose~     disappearance translates complete tumor resection.~      Its interest is twofold:~        -  Increase the percentage of complete tumor resection.~        -  Improve disease-free survival and overall survival. The objective of the study is to~          compare the FGS to the intraoperative neuronavigation for the resection of glioblastoma,~          on a medical and economical level through a randomized, prospective, multicenter trial.~      The annual number of patients likely to benefit of this technique in France is estimated at~     2200 new cases.~   "
134171|NCT01811108|"~     Investigators propose to assess, retrospectively (from 1/7/2009) and prospectively (up to~     31/12/2013,) the safety and tolerability profile (number of participants with adverse events)~     of standard chemotherapy and anti-angiogenic agent bevacizumab (Avastin) as first line~     treatment of patients with metastatic Colorectal Cancer with or without KRAS mutation. All~     treatment schedules that are going to be assessed are considered by the international~     guidelines as standard therapy for patients with metastatic Colorectal Cancer.~   "
134172|NCT01811095|"~     The aim of this study is to determine if training with a robotic simulator improves ability~     to perform robotic suturing. We aim to recruit 38 participants (attending surgeons or~     residents in obstetrics and gynecology, urology, general surgery, or cardiac surgery).~     Participants will be randomized to training with a virtual reality robotic simulator in~     addition to clinical work or to usual clinical work alone for a period of 5 weeks. They will~     be tested at baseline and post-intervention in the task of suturing a inanimate model with~     the actual surgical robot. After the initial study period, the control group will have the~     opportunity to cross over and complete the training and then re-testing.~   "
134173|NCT01811082|"~     The purpose of this study is to compare the lipid lowering effects and clinical safety of a~     natural hypolipidemic compound, coenzyme A capsule with a marketed drug, Pantethine Capsule,~     in Chinese patients with moderate dyslipidemia.~   "
134174|NCT01811069|"~     Upper airway obstruction (UAO) during induction of general anesthesia is a frequently~     occurring complication. The mechanism of UAO during anesthesia shares many similarities with~     the upper airway obstruction observed during obstructive sleep apnea (OSA). Obesity is major~     risk factors for OSA and obese patients have a higher prevalence of UAO during anesthesia.~     The change of body position improved upper airway stability during sleep in patients with~     OSA.We hypothesis that the 30˚ reverse trendelenburg body position maintain airway patency in~     obese patients during general anesthesia.~   "
134175|NCT01811056|"~     This study will test ways to give women more options and flexibility when they are ending~     their unwanted pregnancies. The investigators will look at uptake and acceptability of using~     mifepristone outside of the clinic for pregnancy termination.~   "
134178|NCT01811017|"~     Compare the efficacy of the 755nm Alexandrite laser to the nanosecond 755nm Alexandrite laser~     for the removal of unwanted tattoos using photographic evaluation and histological findings.~   "
134182|NCT01810965|"~     Hemochromatosis type 1 is one of the most frequent genetic disease since the genetic~     predisposition (homozygosity for the C282Y mutation of the HFE gene) is encountered in about~     3/1000 white subjects (5/1000 in Brittany, France).~      For the half of these predisposed subjects, the phenotypic expression of the disease needs a~     treatment. This treatment is based upon repeated bloodletting which is generally considered~     as simple, safe and effective.~      Nevertheless, it is still questioned as regard its physiopathological justification and its~     clinical implications. Indeed, bloodletting could cause an increase of non-transferrin bound~     iron (NTBI) particularly for its reactive form called labile plasma iron (LPI) This adverse~     physiopathological effect could have clinical consequences and could be linked with articular~     consequences which can be aggravated by the treatment.~   "
134183|NCT01810952|"~     The investigators hypothesize that includes patient weight and glucocorticoid dose can be~     used to safely initiate insulin treatment in diabetic/hyperglycemic patients who are to be~     treated with pharmacological doses of glucocorticoids.~   "
134184|NCT01810939|"~     The purpose of this study was to evaluate the efficacy and safety of patiromer~     (investigational drug) in the treatment of hyperkalemia (high serum potassium). The study~     also evaluated the effect of withdrawing patiromer treatment and assessed whether chronic~     treatment with patiromer prevented the recurrence of hyperkalemia. The safety of patiromer~     treatment was also evaluated.~   "
134185|NCT01810926|"~     • The primary aim of the present trial is to assess in a randomized fashion the benefit on~     standard graft-versus-host disease (GVHD) prophylaxis of the addition of ATG-Fresenius S ® in~     transplants from matched related donors (MRD) and of anti-CD20 rituximab in transplants from~     matched unrelated donors (MUD). Both safety and efficacy of the treatment will be assessed,~     in particular in respect to the clinical status of the patient, i.e. prevention of graft~     failure and chronic GvHD and of Ebstein Barr virus (EBV) viremia for MUD patients.~      The conditioning proposed combines myeloablative drugs with a favorable safety profile such~     as treosulfan, thiotepa (Tepadina®) and fludarabine with the intent to reduce the traditional~     immediate and late toxicity of busulfan and cyclophosphamide.~   "
134186|NCT01810913|"~     This randomized phase II/III trial studies how well radiation therapy works when given~     together with cisplatin compared to docetaxel or cetuximab and docetaxel after surgery in~     treating patients with stage III-IV squamous cell head and neck cancer. Specialized radiation~     therapy that delivers a high dose of radiation directly to the tumor may kill more tumor~     cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin~     and docetaxel, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can~     block tumor growth in different ways. Some block the ability of tumor cells to grow and~     spread. Others find tumor cells and help kill them or transmit tumor killing molecules to~     them. It is not yet known whether radiation therapy is more effective when given with~     cisplatin, docetaxel, or cetuximab and docetaxel.~   "
134187|NCT01810900|"~     This multicenter, randomized, single-blind study assessed the safety and efficacy of~     Protescal for the reduction of post-operative adhesion formation following myomectomy.~   "
134188|NCT01810887|"~     The purpose of this study is to evaluate the pharmacokinetics (explores what the body does to~     the drug) and safety of darunavir, and will be administered in combination with Ritonavir in~     healthy adult Japanese male participants.~   "
134189|NCT01810874|"~     The purpose of this study is to determine whether the extraperitoneal approach is better than~     the transperitoneal approach for laparoscopic aortic lymphadenectomy for the surgical staging~     of endometrial or ovarian cancer.~   "
134190|NCT01810861|"~     The aim of this study is to specify the serotype distribution of Streptococcus pneumoniae~     that causes invasive diseases at children and adults in Turkey.~   "
134191|NCT01810848|"~     Osteoarthritis of the knee is a degenerative joint disease that involves degradation of the~     joint. Symptoms include joint tenderness, pain, stiffness, locking, and occasionally an~     effusion. Over 40 million Americans also have cardiovascular disease in addition to their OA.~     Initiation and maintenance of even low-levels of physical activity is critical for management~     of cardiac risk. Patients with osteoarthritis have been shown to have poorer aerobic~     conditioning, lower daily physical activity levels and lower self-efficacy for exercise than~     non-OA cohorts.~      It has been established that there exists a consistent gradient across activity groups~     indicating greater longevity and reduced risk of CHD, CVD, and stroke, in more active~     individuals. Available research suggests the greatest gains in cardiovascular fitness occur~     in moving a sedentary individual to even low levels of physical activity, and 12 weeks is~     enough to demonstrate change in the risk profile of at-risk individuals.~      Finally, appropriate levels of aerobic and strength training have been shown to be beneficial~     in treatment of osteoarthritis of the knee. This study will evaluate the effectiveness of~     hylan G-F 20 (single injection preparation) in promoting greater levels of physical activity~     and fitness as measured by MET level compared to an exercise-only cohort; evaluating both the~     change in physical function as well as the cardiovascular risk profile. This is a randomized,~     single-blinded clinical trial comparing injection of the knee joint with Hylan GF-20 to sham~     procedure. Subjects will undergo a regular exercise program for 6 months following~     randomization.~   "
134192|NCT01810835|"~     The prevalence of HBsAg carriage in pregnant women varies in France, according to the native~     country, with highest rates in those originating from sub-Saharan Africa and Asia (5 to 8 %~     in Parisian area). The level of HBV-DNA varies according to HBe status and geographical~     origin, and is strongly predictive of the risk of HBV mother-to-child transmission (MTCT). It~     has been shown that the rate of vertical transmission (Chinese study by Yuan J et al) was 0 %~     in newborns to mothers whom HBV-DNA was < 105 copies/mL and up to more than 40 % in newborns~     to mothers with high viral loads > 108 copies/mL, despite HBIg and vaccine at birth. Thus,~     data are needed concerning the current practices about the prevention of HBV MTCT in France,~     and their results.~   "
134193|NCT01810822|"~     Oxidative stress is involved in the pathophysiology of diabetic nephropathy. The~     superoxide-generating nicotinamide adenine dinucleotide phosphate-oxidase 2 (NOX2, encoded by~     the CYBB gene) and the antioxidant enzyme glutathione peroxidase 4 (GPX4) play opposing roles~     in the balance of cellular redox status. In the present study, we investigated associations~     of single nucleotide polymorphisms (SNPs) in the regulatory regions of CYBB and GPX4 with~     kidney disease in patients with type 1 diabetes.~   "
134198|NCT01810757|"~     Background Localised muscle invasive bladder cancer (MIBC) is life-threatening and can cause~     significant symptoms. Around 50% of patients with MIBC who are referred for radiotherapy are~     unfit for standard radical treatment (surgery or daily radiotherapy with chemotherapy), but~     would have a normal life expectancy if their cancer were adequately controlled. Retrospective~     studies suggest that radiotherapy which is given weekly using fewer fractions and higher~     doses (hypofractionated), may be an alternative where daily radiotherapy is not an option.~      Radiotherapy treatment is planned based on information from a CT scan which shows the~     position and shape of the bladder. This plan needs to take into account the fact that the~     bladder's shape and position can change, depending on how full it is and because of where it~     is in relation to the bowel. A safety margin is therefore added around the bladder on the~     planned treatment, to reduce the risk of missing any of the bladder with the radiotherapy.~      It is now possible to take scans of the bladder's position before each treatment and adjust~     the position of the treatment plan accordingly to ensure the bladder is fully covered by it.~     In this study we are also looking at whether it is possible to design a series of treatment~     plans with different size safety margins and then choose one that fits best for each~     particular day. This is called 'adaptive radiotherapy'. This technique may enable accurate~     treatment delivery using smaller safety margins and this might help to reduce side effects.~      Aims~      In patients with MIBC not suitable for cystectomy or daily radiotherapy we aim to assess:~        1. whether treatment using adaptive planning can be successfully delivered at multiple~          sites across the UK and results in acceptable levels of toxicity~        2. the local tumour control rate achieved by hypofractionated weekly radiotherapy~        3. the requirement to treat with adaptive planning.~      How results will be used Results will provide robust evidence for use of hypofractionated~     radiotherapy and assess whether this is a plausible and worthwhile treatment in this patient~     population. The randomised element of the trial will support the implementation of~     image-guided adaptive radiotherapy for bladder cancer in the UK. HYBRID will provide evidence~     on the benefits or otherwise of this methodology and inform the development of further trials~     in this and other patient groups.~   "
134199|NCT01810744|"~     The treatment of the most common cancers (colon, breast, lung, liver and kidney) has recently~     added a new therapeutic class known as the anti-angiogenic. It was born from a better~     understanding of tumor growth requires the development of neo-vessels. These new vessels are~     of major importance for the viability of the tumor but also the birth of metastases. This~     neo-angiogenesis is complex and results from an imbalance between pro-angiogenic factors and~     anti-angiogenic factors. Growth factor VEGF and its receptors (VEGFR-1, VEGFR-2 and VEGFR-3)~     are a way of survival of endothelial cells required for tumor neoangiogenesis. The~     anti-angiogenic drugs currently available on the market are bevacizumab (Avastin ®),~     sunitinib (Sutent ®) and sorafenib (Nexavar ®). The mechanism of anti-angiogenic action of~     these three main drugs are pharmacological inhibition of the VEGF pathway.~      These new anti-angiogenic therapies, however, have significant adverse effects are common and~     some other more serious but rare.~      Hypertension is the most common side effect observed in patients treated with anti-VEGF. This~     is usually iatrogenic hypertension controlled by antihypertensive therapy and rarely~     compromises the pursuit of anti-angiogenic therapy. More rarely, it can have serious~     consequences malignant hypertension, severe hypertension refractory reversible posterior~     leukoencephalopathy associated with severe hypertension have also been reported.~      The pathophysiology of hypertension may be due to the neutralization of major physiological~     effects of VEGF in endothelial cell and therefore the vascular wall.~      The study of the microcirculation is not only useful in the diagnosis of microvascular but~     also macrovascular disease in the evaluation of chronic arterial and venous severe it~     determines the prognosis. In these indications, capillaroscopy remains the gold standard for~     all work pathophysiological because visualization of phenomena measured avoids artifacts and~     difficulties of interpretation. It then appealed to additional technology to directly measure~     the capillary pressure, capillary flow velocity, and indirectly assess capillary permeability~     and function of lymphatic canaliculi. The simplest of these technological inputs: video~     microscopy and digital image analysis, have also improved the practice of routine clinical~     capillaroscopy in its main field of application, evaluation of microangiopathy connective.~     The examination can be performed more quickly and easily archived and quantified.~      Only two studies on 14 and 16 patients were able to see a decrease in capillary density~     correlated with the therapeutic activity of anti-angiogenic the tumor mass and metastasis.~      Thus, we propose to quantify in a number of relatively large patient patients the decrease in~     capillary density as well as the relationship between the decrease in the number of~     capillaries and anti-tumor response.~      The study will also aim to measure the prevalence of hypertension in patients treated with~     bevacizumab and to establish the link between these data and the modification of the~     capillary microcirculation.~   "
134200|NCT01810731|"~     In 2012, the WHO Strategic Advisory Group of Experts (SAGE) concluded that pregnant women are~     the most important risk group for season influenza vaccination based upon compelling~     evidence of substantial risk of severe disease in this group and evidence that seasonal~     influenza vaccine is safe and effective in preventing disease in pregnant women as well as~     their young infants, in whom disease burden is also high. Recent data from Kenya, similarly~     suggest rates of influenza-associated hospitalizations in children under age 1 to be as high,~     or higher, than those observed in the United States. However, TIV may have reduced~     immunogenicity in HIV-infected adults, and HIV infection has been shown to reduce placental~     transfer of both tetanus and measles antibodies. Therefore, we propose to conduct a~     double-blind randomized controlled trial of influenza vaccines stratified by HIV status in up~     to 720 pregnant women in their second and third trimesters and their infants residing in~     health and demographic surveillance sites (HDSS) in Nyanza Province, Western Kenya. We~     propose to assess the safety, immunogenicity, and efficacy of standard dose QIV and double~     dose QIV in HIV-infected and HIV-uninfected pregnant women. Findings will inform maternal~     influenza vaccination policies in Kenya and other African countries.~   "
134201|NCT01810718|"~     Chronic Graft versus Host Disease (cGvHD) has been identified as the leading cause of late~     non-relapse mortality in Hemopoietic Stem Cell Transplant (HSCT) survivors. Up to now a~     standard satisfactory treatment for these patients does not exist. cGVHD is an~     immune-mediated disease, resulting from a complex interaction between donor and recipient~     adaptive immunity, but its exact pathogenesis is still incompletely defined.~      The purpose of this study is to determine safety and efficacy of Nilotinib in a population~     with steroid-refractory/or steroid-dependent cGvHD with a phase I study.~      In phase II the MTD will be used to define the efficacy of Nilotinib in a cGvHD steroid-~     refractory or steroid dependent population, with the same characteristics of the previously~     Imatinib-treated population.~   "
134202|NCT01810705|"~     The protocol aims at adding GRASPA (L-asparaginase encapsulated in red blood cells,~     eryaspase) to standard chemotherapy (low-dose cytarabine) to treat patients older than 65~     years diagnosed with AML and unfit for intensive chemotherapy.~   "
134203|NCT01810692|"~     In COPD the patient's ability to use inhalers correctly and their preference for the inhaler~     are both important factors in selecting an appropriate treatment for COPD. This is a~     cross-sectional study where satisfaction, preference and handling of two different devices~     such as Respimat and Breezhaler will be evaluated by using the validated PASAPQ in COPD~     patients~   "
134204|NCT01810679|"~     To demonstrate the safety and effectiveness of the Perceval S heart valve when used to~     replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.~   "
134205|NCT01810666|"~     Comparison of the effect of three times a week prophylaxis on all bleeds with on-demand~     treatment for children with severe Hemophilia A.~   "
134206|NCT01810653|"~     The study design combines a long-term safety and a dose range determination objective. The~     first 8 weeks of the study were primarily intended for the dose range determination, while~     the later visits were used for the comparison of long-term safety between the groups.~   "
134207|NCT01810640|"~     This study's objective is to obtain preliminary data to test the hypotheses that percutaneous~     liver biopsy in brain death donors is safe and provides reliable histological information.~     Furthermore, that information when disseminated fully and widely many hours before organ~     recovery would not only decrease economic costs of wasteful recovery of livers that are not~     ultimately transplanted but also increase transplantation and decrease cold ischemia times of~     recovered livers.~   "
134208|NCT01810627|"~     This is a non-randomized study to evaluate the utility of MVCT as a quality assurance measure~     in patients treated with interstitial permanent seed implants for low and intermediate risk~     prostate cancer. All patients will received the same standard of care treatment but will~     receive an additinoal CT image of the prostate.~   "
134209|NCT01810614|"~     Recent evidence has shown that kidney volume predicts the likelihood of developing renal~     insufficiency over a finite length of time in ADPKD, suggesting a linkage between the growth~     of cysts and the harm they do to kidney function. Recent studies indicate that the rate of~     kidney volume increase is hastened by excess dietary protein, salt, and potential net acid~     precursors, and slowed by increased water intake sufficient to lower plasma vasopressin~     levels.~      Diets are commonly prescribed to treat ADPKD and other renal patients with disease near the~     end-stage, but there is currently no specific diet prescription that takes potentially~     harmful dietary elements into account for ADPKD patients in the earliest stages of the~     disease. This study will examine a novel diet for ADPKD created by the researcher termed the~     ADPKD diet.~   "
134210|NCT01810601|"~     To assess the effect of transabdominal ultrasound guided embryo transfer on the pregnancy~     rates versus clinical touch technique~   "
134876|NCT01801891|"~     This study aims to determine if the use of surface neuromuscular electrical stimulation,~     applied to various motor points on the lower limb to elicit muscle contraction when combined~     with compression bandaging accelerates the rate of venous leg ulcer healing.~   "
134211|NCT01810588|"~     In this trial, we aim to improve the outcomes of haplo cord transplant. Haplo cord transplant~     is a novel and promising way to improve transplant outcomes. We hypothesize that~     identification of a graft that is at least 5/6 matched and inherited paternal antigen (IPA)~     targeted (i.e., cord blood grafts share one or more IPA antigens with the prospective~     recipient) is more important to the outcome of haplo cord transplant than the nucleated cell~     dose. The identification of such a graft for a large proportion of the subjects may~     necessitate accepting a lower umbilical cord graft dose.~      In addition to a umbilical cord blood transplant, recipients will receive stem cells from a~     family member ( a haplo-identical donor) . After collection and prior to infusion, these~     cells will be purified using a device called a CliniMACS CD34 selection device. The subject~     will undergo a chemotherapy conditioning regimen prior to transplantation. No experimental~     drugs are used in this study, and the combinations of drugs that will be used in the~     conditioning regimen are combinations that have been used in the past.~   "
134212|NCT01810575|"~     The purpose of this study is to assess the safety & efficacy of a single dose of alprostadil~     cream with 2 concentrations of WC3036 compared to vehicle alone in men with erectile~     dysfunction.~   "
134213|NCT01810562|"~     The purpose of this study is to determine whether tactile stimulation for reduced sensibility~     of the affected extremities after stroke has effect.~      Hypothesis:~      Stimulation of sensibility after stroke will have a significant contribution for improved~     sensibility. Without any stimulation, no signal is sent to the brain and there is no need for~     the healthy parts of the brain to adapt this function. Stimulation of the sensibility over a~     period of time on both sides of the body, gives the brain signals and the opportunity to~     compare how the signals should be recognized. New connection will be able to interpret~     signals correctly.~   "
134214|NCT01810549|"~     The aim of the study is to investigate, if postprandial fatigue symptoms after ingestion of a~     high-fat, high-carbohydrate meal are regulated by Interleukin (IL)-1 and can be prevented by~     inhibition of IL-1 using a single dose injection of a specific IL-1 receptor antagonist.~   "
134215|NCT01810536|"~     Respiratory exacerbations are frequent among cystic fibrosis patients and supplemental oxygen~     is usually required. We will compare a new high flow nasal cannula system with Venturi masks~     for oxygen supplementation to patients with CF hospitalized for respiratory exacerbation.~   "
134216|NCT01810523|"~     Study will test the use of narratives on patient satisfaction and translation of an~     evidence-based approach to the use of X-rays for leg injuries in the Emergency Department~     (ED). The investigators will identify patients with foot, ankle, or knee injuries for whom~     X-rays are determined to not be needed. On discharge, patients will receive the current~     fact-based sheet or that plus a narrative explaining the work-up and treatment of these~     injuries. Outcomes will be assessed by a survey measuring patient satisfaction and~     understanding.~   "
134217|NCT01810510|"~     The purpose of this study is to determine whether two modes of artificial (i.e. mechanical)~     ventilation have an impact on patient synchrony with the ventilator (breathing machine) and~     on the patient's work of breathing.~   "
134218|NCT01810497|"~     The aim of the study is to investigate the possible influence of different durations of use~     of postoperative elastic bandaging (seven days vs. thirty days) in the results of otoplasty.~     We hypothesize that the duration of elastic bandage use has no significant influence on the~     incidence of relapse of prominence of the ears and need for reoperation.~   "
134219|NCT01810484|"~     Up to 20 subjects will be enrolled. Enrolled subjects will receive one of three study~     treatments in the abdominal region: Ultherapy® only, Ultherapy® and CO2 laser treatment, or~     CO2 laser treatment only. Follow-up visit will occur at 14, 90 and 180 days post-treatment.~     Study images will be obtained pre-treatment, approximately 30 minutes post-treatment, and at~     each follow-up visit.~   "
134220|NCT01810471|"~     Untreated ankle sprains often remain symptomatic and may end in chronic instability. The aim~     of our study is to quantify the stabilizing effect of different devices. Through the use of a~     foot measurement model in 3D motion analysis the influence of the devices with respect to a~     mechanical effect is examined by means of different tests. The dynamic postural control is~     quantified. The hypothesis was that the devices would stabilize differently the foot~     segments.~   "
134221|NCT01810458|"~     We hypothesize that individuals with Alpha-1 Antitrypsin (AAT) deficiency have ongoing liver~     injury which is not detected by the usual blood tests used to look at liver function. This~     ongoing liver injury leads to cirrhosis in a significant number of adults with AAT~     deficiency.~   "
134222|NCT01810445|"~     The purpose of this pilot study is to develop the methodology for an innovative subsurface~     imaging technology that was designed at Lawrence Livermore National Laboratory. It will allow~     the non-invasive analysis and imaging of tissues and chemical distributions in the body at an~     imaging depth of up to 1 centimeter with spatial resolution on the order of 1 mm.~   "
134223|NCT01810432|"~     The purpose of this study is to measure how much of the drug gets into the blood stream and~     how long it takes the body to get rid of it when given to healthy participants. Information~     about any side effects that may occur will also be collected.~      The study has 2 periods. In each period, participants will take the study drug for 10 days,~     either with or without a meal. There is a minimum 14 day washout between each period.~      This study is approximately 50 days, not including screening. Screening is required within 28~     days prior to the start of the study.~   "
134224|NCT01810419|"~     In internal medicine, assessment of spleen size on physical examination is an extremely~     important part of the overall evaluation of patients with many illnesses. Examination of the~     spleen is also one of the core competencies that the investigators expect our students and~     residents to learn as part of their training. Unfortunately, the sensitivity and specificity~     of examination of the spleen at the bedside is not very good. The investigators wish to~     determine if handheld ultrasound can accurately assess spleen size. Doing so would make~     physical examination of the spleen obsolete and transform training objectives for medical~     students and residents.~   "
134260|NCT01809938|"~     Most pre-operative fasting regimes dictate that if there is any milk added to tea or coffee,~     the preoperative fasting time should be extended from 2 to 6 hours. The purpose of this study~     is to demonstrate whether there is really a delay in gastric emptying time associated with~     the inclusion of milk in a cup of tea.~   "
134225|NCT01810406|"~     Combined spinal-epidurals (CSE) involve the injection of pain relief medication into the~     cerebral spinal fluid (CSF) and the insertion of an epidural catheter in the epidural space~     to continue to give pain relief medication. During a CSE, after injection of the medication~     in the CSF and before inserting the epidural catheter, if normal saline is injected into the~     epidural space, there may be an increase in pain relief and an increase in the level of~     numbness. This injection of saline in the epidural space to increase pain relief and numbness~     is termed epidural volume extension (EVE). The purpose of this study is to determine if there~     is a benefit for EVE to improve labor analgesia (pain relief) using CSE in pregnant laboring~     patients.~   "
134226|NCT01810393|"~     This open-label, randomized, multicenter study will evaluate participant preference for~     subcutaneous (SC) versus intravenous (IV) trastuzumab (Herceptin) in participants with~     HER2-positive metastatic breast cancer responding to first-line treatment with IV trastuzumab~     for at least 3 years. Participants will be randomized to receive either 3 cycles (cycle~     length = 21 days) of trastuzumab SC followed by 3 cycles of trastuzumab IV or 3 cycles of~     trastuzumab IV followed by 3 cycles of trastuzumab SC. All participants will receive~     trastuzumab SC for Cycles 7 to 18. Anticipated time on study treatment is 1 year or until~     disease progression or inacceptable toxicity occurs, whichever comes first.~   "
134227|NCT01810380|"~     To determine the efficacy and safety of brexpiprazole for the treatment of adults~     experiencing an acute episode of schizophrenia.~   "
134228|NCT01810367|"~     Assess the PFS/ORR/OS of ABX Combined With Cisplatin Compared With Gemcitabine Combined With~     Cisplatin in first Treatment of NSCLC~   "
134229|NCT01810354|"~     Surgical site infections are common and a cause of major morbidity. They are also more common~     in obese women. Cesarean sections are the most common surgery performed in the United States,~     therefore pregnant women are being faced with this problem frequently. There is evidence to~     show that prophylactically administered antibiotics, cefazolin specifically, to obese women~     prior to cesarean section do not reach adequate concentrations in adipose tissue to prevent~     infection. The purpose of this study is to evaluate if an increased dose of cefazolin will~     attain adequate tissue concentration in obese women. Our hypothesis is that three grams of~     cefazolin given no more than 60 minutes prior to the start of a cesarean section in an obese~     (Body mass index (BMI) greater than or equal to 30) woman will attain adequate adipose tissue~     concentration compared to two grams of cefazolin.~      Subjects will be selected if they are greater than 37 weeks gestation wiht a singleton~     pregnancy and require a cesarean section for any obstetrical indication. Women will be~     excluded if they have a suspected infection, have a multiple gestation, or have preexisting~     diabetes or hypertension with end organ damage. The subjects will be screened both by through~     the OR schedule as well as through the clinics. They will then be consented and enrolled by~     the primary investigator. Once enrolled the subjects will be randomized to receive either two~     grams or three grams of cefazolin as prophylactic antibiotics to be given no more than 60~     minutes prior to the start of the surgery.~      Two adipose tissue samples will be obtained at the time of surgery. The first at the start~     after skin incision and the second at the end prior to closure of the skin. There will also~     be a separate IV placed at the start of the procedure from which three blood draws can be~     collected. These three samples will be obtained at the start of the surgery but after~     antibiotic administration, at the time of the first adipose collection, and at the time of~     the second adipose collection. The samples will then be stored at -80 degrees and shipped to~     David P. Nicolau's lab in Hartford, CT for the tissue and serum analysis.~      While the subjects are in the hospital recovering from their surgery, a chart review will be~     performed to determine if there are any infections occuring post-operatively. A telephone~     survey will be conducted six to eight weeks postpartum again assessing for any infectious~     complications after the cesarean section.~   "
134230|NCT01810341|"~     This study will prospectively enroll approximately 880 children, at least 18 months and less~     than 60 months of age, who have been referred to a pediatric developmental evaluation center.~     Enrolled children will have blood drawn for RNA gene expression analysis and optionally for~     metabolite, lipid and DNA analysis and undergo a clinical evaluation to determine the~     presence or absence of a diagnosis of ASD.~      The primary objective of this study is:~      - To develop an algorithm to classify blood RNA gene expression patterns to maximize~     agreement between the classification and a clinical assessment of presence or absence of~     Autism Spectrum Disorders (ASD).~      The secondary objectives of this study are:~        -  To develop an algorithm to classify plasma metabolite and/or lipid profiles in such a~          way as to maximize agreement between the classification and a clinical assessment of~          presence or absence of ASD.~        -  To prospectively assess the clinical sensitivity and specificity of the plasma~          metabolite and/or lipid profile classification algorithm in a separate population~          consisting of children referred to a developmental evaluation clinic for a possible~          developmental disorder (DD).~        -  To evaluate clinical sensitivity and specificity of various combinations of gene~          expression signature, metabolite and/or lipid signatures, and presence of ASD-associated~          genetic variation detected by chromosomal microarray analysis (CMA) or sequencing~          protein-coding regions of the genome.~   "
134231|NCT01810328|"~     The purpose of this study is to learn more about how to treat patients with severe injuries~     related to trauma and to prevent failure of vital organs in this patient population.~     Approximately 200 severely injured patients with blunt trauma and 40 healthy volunteer~     subjects will be enrolled in this study. During the study seven blood samples (4-5 mls) will~     be collected from patients who have suffered severe trauma over a 28 day period. A one time 5~     ml blood sample will be collected from the healthy volunteers. Clinical data will be~     collected daily while patients are hospitalized. The initial blood sample must be collected~     from qualifying patients within the first 12 hours of admission to the hospital. The reason~     for blood sampling is to validate a rapid genomic test in real time. Once confirmed, this~     genomic test can be used to identify patients who will have a complicated clinical course and~     would, therefore, be good candidates for interventional, immunomodulatory therapies.~   "
134232|NCT01810315|"~     Purpose of the study is to assess tenofovir (TFV) PK and PD endpoints, cervicovaginal safety~     parameters, susceptibility to HIV-1 infection, and objective measures of vaginal applicator~     use in premenopausal and postmenopausal women.~   "
134233|NCT01810302|"~     The purpose of this study is to determine if intrathecal nicardipine is safe for the~     treatment of cerebral vasospasm.~   "
134234|NCT01810289|"~     START is clinic-level (not individual-patient) intervention to catalyze the process of ART~     initiation among HIV-infected adults who meet CD4-based criteria for combination ART (e.g.,~     adults with a CD4 T cell level < 350/ul). The three START components are: (1) real-time~     point-of-care CD4 testing using the Alere PIMA platform to ascertain treatment eligibility in~     real time at first presentation to care, (2) targeted knowledge transfer (i.e.,~     dissemination) of recent scientific evidence regarding effects rapid ART initiation on~     survival to front line health care workers; and 3) feedback and reporting to clinic and~     providers. There three components represent empirically validated steps in the PRECEED~     implementation model.~   "
134877|NCT01801878|"~     The aim of this study is to evaluate the skin quality of using adipose-drived stromal~     vascular fraction (SVF) cell taken by automatic centrifuge for adipose-drived cell isolation~     system into irradiated breasts.~   "
134235|NCT01810276|"~     The objective of this study is to determine if the administration of platelets will improve~     outcome in patients with ICH who are being treated with either aspirin, a thienopyridine~     (ticlodipine, clopidogrel, prasugrel) or a combination of both. The study has four specific~     aims:~        1. To determine what affect platelet administration will have on bleeding in the brain.~        2. To determine what affect platelet administration will have on brain function. Several~          assessments to test the functioning of the brain will be performed at enrollment and~          throughout the study. Comparing the results of these assessments between the~          experimental and control groups should allow us to determine if platelet administration~          improves outcomes in patients with bleeding in the brain exposed to antiplatelet~          therapy.~        3. An important risk of reversing antiplatelet therapy is exposing the patient to the very~          complications this therapy was designed to prevent. Therefore, tracking complications~          will be a very important part of this study. The investigators will compare the rates of~          death, heart attack, stroke and clots in the veins between groups.~        4. Some patients (10-40%) have limited responsiveness to antiplatelet therapy. While~          platelet responsiveness, as measured by a special platelet blood test, will not affect~          enrollment, the investigators feel it will be important to measure.~   "
134236|NCT01810263|"~     The aim of this prospective randomized controlled study is to demonstrate the efficacy of~     Intensive Nutritional Supplement in Patient with Stroke.~   "
134237|NCT01810250|"~     The Department of Vascular Surgery at Catharina Hospital Eindhoven, The Netherlands initiates~     the Endurant for Challenging Anatomy: Global Experience (EAGLE) Registry. The aim of this~     study is to collect clinical information on the performance of the Endurant Stent Graft~     System for endovascular repair in anatomically challenging aneurysms, and to critically~     assess whether the current guidelines for anatomic eligibility to endovascular treatment with~     this system are still applicable. This study aims at creating a database that can be pooled/~     compared with the ENGAGE database.~      This study aims at answering two major questions:~        1. Is the technical success rate of successful delivery and deployment of the Endurant (II)~          similar in anatomically challenging aneurysm?~        2. Is the successful treatment rate comparable in anatomically challenging aneurysms, or~          does treatment of these aneurysms lead to more complications and reinterventions?~   "
134238|NCT01810237|"~     Research Questions:~        1. Does using dabigatran bridging result in consistent therapeutic anticoagulation? What~          percentage of patients will become subtherapeutic on warfarin once dabigatran is~          stopped?~        2. What is the incidence of bleeding events with the use of dabigatran overlapped with~          warfarin for bridging?~        3. What is the cost benefit of using dabigatran instead of dalteparin for bridging~          anticoagulation?~   "
134239|NCT01810224|"~     This is prospective, randomized, multicenter, multinational, randomized (1:1) study. The aim~     of this study is to assess the importance of functional assessment of coronary artery disease~     prior to bypass surgery. In particular, an FFR-guided strategy will be compared to the~     traditional Angio-guided strategy in the guidance of surgical revascularization by~     aorto-coronary bypass grafting.~   "
134240|NCT01810211|"~     This study will look at which, if any, active stretching procedure is most effective at~     correcting posterior shoulder tightness (PST) in the post-operative population. Posterior~     shoulder tightness can influence shoulder mobility and function within both a symptomatic and~     an asymptomatic population. There are previous studies that have examined the effectiveness~     of different active stretching procedures and their ability to correct PST but only in the~     asymptomatic population. As clinicians it will be helpful to investigate their effect within~     a symptomatic population in order to prescribe appropriate and effective stretches within an~     individual's home exercise program. The study design is a double blinded randomized control~     trial. During evaluation a passive measurement of PST and internal rotation will be~     performed. Another therapist, blinded to the measurements, will randomly select which~     subgroup the individual will be placed in for the first three individuals and this sequence~     will be followed for the remainder of the participants. At this time the therapist will~     instruct the individual on the corresponding exercise which they will perform in front of~     that therapist. The individual will perform this exercise one more time that day and twice~     the following day and once again upon follow up prior to having internal rotation and PST~     measured once again. At this point this will be the conclusion of that individuals~     involvement in the study.~      Null Hypothesis1: Stretches are no more effective than no treatment for reducing PST acutely~     in the post-operative shoulder population.~      Hypothesis1: Stretches are more effective than no treatment for reducing PST acutely in the~     post-operative population.~      Null Hypothesis2: There is no significant difference in the reduction of PST between the~     horizontal adduction stretch and the modified sleeper stretch acutely in the post-operative~     shoulder population.~      Hypothesis2: There is a significant difference in the reduction of PST between the horizontal~     adduction stretch and the modified sleeper stretch acutely in the post-operative shoulder~     population.~   "
134241|NCT01810198|"~     To determine the effectiveness, safety, and cost efficiency associated with a CCTA-guided~     selective catheterization strategy for stable patients but without known CAD and an American~     Heart Association/ American College of Cardiology Class II indication for non-emergent~     invasive coronary angiography.~   "
134242|NCT01810185|"~     The investigators will be looking at the efficacy of the use of once daily use of low dose~     naltrexone (4.5mg) in subjects with symptomatic inflammatory bowel disease.~   "
134243|NCT01810172|"~     Often the decision for chest tube removal or trial of chest tube clamping is based on~     subjective assessment. This can lead to delay in chest tube removal. Recently, monitoring and~     recording of air leaks has been done using digital pleural drainage devices. This provides us~     with objective and continuous recording of air leaks as well as changes in pleural pressure.~     Our hypothesis is that the use of the ATMOS digital pleural drainage system will result in~     shorter hospital stay in comparison to traditional pleural drainage systems.~   "
134244|NCT01810159|"~     Primary care settings (PCS) are a missed opportunity for delivering evidence-based treatments~     for opiate and alcohol-use disorders (OAUD). The investigators propose to evaluate the costs~     and effectiveness of two strategies to increase the delivery of OAUD treatments in PCS,~     integrated collaborative care (ICC) and education and resources (E&R). The investigators~     hypothesize that ICC will be more effective than E&R in promoting A. Implementation outcomes~     B. Service system outcomes and C. Patient outcomes.~      Results from our study will help providers choose between two different strategies and~     advance the field of implementation research.~   "
134245|NCT01810146|"~     60 patients scheduled for bariatric surgery will be included into 3 categories (20 patients~     with non complicated obesity, 20 patients with metabolic syndrome and 20 patients with a type~     2 diabetes or hypertension). 20 volunteers will be enrolled as normal referents. The patients~     and the volunteers will have a classical pre-operative check-up (fibroscopy, oesophageal~     pHmetry and manometry) and extra investigations as isotopic gastric empty exam, lactulose~     oro-caecal transit exam, intestinal permeability test calculated by lactulose-manitol ratio~     urinary excretion. Intestinal and colonic biopsies will be also provided for studying~     permeability. For only patients, samples from the gastric resection will be provided for~     analysing the enteric nervous system and motricity.~   "
134246|NCT01810133|"~     Peri-operative mortality depends on the patient's co-morbidities. ASA Physical Status~     (American Society of Anesthesiology) is the most commonly scale to assess this parameter and~     has yet been repeatedly criticized in the past for its discriminatory power.~      Few studies have shown both the ASA physical status and the more detailed and more~     time-consuming Charlson Comorbidity Index to be equivalent in certain patient populations.~      The purpose of this observational study is to compare the predictive value of both scales~     with regards to all-cause in-hospital mortality and hospital length of stay.~   "
134247|NCT01810120|"~     Allocation: Non-Randomized Endpoint Classification: Safety/Feasibility Intervention Model:~     Single Group Assignment Masking: Open Label Primary Purpose: Treatment Study to assess the~     feasibility and safety of the infusion of a T cells receptor (TCR) alfa beta depleted graft~     in pediatric patients affected by malignant and non-malignant hematological disorders and~     receiving an Hematopoietic stem cell transplantation (HSCT) from a Human leukocyte antigen~     (HLA) partially matched family donor.~   "
134248|NCT01810107|"~     The specific aim of this study is to develop a growth and development chart (similar to a~     height or weight chart for children) that identifies the pattern of development of the~     pediatric vocal cord lamina propria from a single to a three layer structure. A secondary aim~     is to identify whether this growth chart shows a pattern of linear development or whether~     there are clear critical periods of development.~   "
134249|NCT01810094|"~     Spinal injuries, such as vertebral fractures, often result in a significant instability of~     the spine and lead to acute or delayed neurological deficits. Depending on the type of injury~     there are various methods available to stabilize the spine. The proposed study should clarify~     whether the combined reduction and fixation with a minimally invasive approach can actually~     be done with the same precision as in a conventional approach. The primary endpoint of this~     investigation is the monosegmental anterior wedge angle (AWA), and its maintenance over the~     first 6 postoperative weeks. It is the aim of the study to gather key radiological, clinical~     and subjective patient outcome parameters for its patient population that will allow to~     compare the results to a historical group of patients. The study design is~     non-interventional, prospective, open,and multicentric.~   "
134250|NCT01810081|"~     In this study, the presence of H.Pylori in the gallbladder mucosa of patients with~     symptomatic gallstones undergoing cholecystectomy was investigated. Concomitant H.Pylori~     infection of the gastric mucosa was also investigated to study the relationship of gastric~     H.Pylori infection to gallstones. It was hypothesized that H.Pylori infection of the gastric~     mucosa may have a role in the formation of gallstones.~   "
134251|NCT01810068|"~     The impact of of different surgical treatment modalities of benign prostatic hyperplasia in~     men on their sexual function is not well studied.~      The investigators will investigate prospectively the effect of conventional monopolar~     transurethral resection of the prostate (TURP), bipolar TURP and Holmium laser enucleation on~     urinary and sexual functions.~   "
134252|NCT01810042|"~     Exudative age-related macular degeneration (ARMD) is complicated by choroidal~     neovascularization (CNV). Although anti-vascular endothelial growth factor treatment is the~     gold standard treatment, recurrence is the main limitation of the treatment. The changes of~     the CNV vascular structure is expected to provide information regarding recurrence. In the~     eyes that the vascular structure is clearly seen in indocyanine green angiography (ICGA), the~     vascular changes after ranibizumab injections will be investigated prospectively.~   "
134253|NCT01810029|"~     The overall hypothesis of this study is that a cardiac rehabilitation program with meditation~     will be more effective than cardiac rehabilitation alone in improving blood flow through the~     diseased coronary arteries in African Americans. For this purpose, 56 African American men~     and women with coronary heart disease will be randomly assigned either to standard cardiac~     rehabilitation plus the Transcendental Meditation program or to standard cardiac~     rehabilitation alone. The treatment period will be 12 weeks in length.~   "
134254|NCT01810016|"~     The purpose of this study is to evaluate the safety, tolerability and immunogenicity of~     Ipilimumab i.v. followed by NY-ESO-1 Protein vaccine with Poly-ICLC and Montanide s.c. (Arm~     A), or NY-ESO-1 OLP4 vaccine with Poly-ICLC and Montanide s.c. (Arm B), or NY-ESO-1 OLP4~     vaccine mixed with Poly-ICLC without Montanide s.c.(Arm C).~   "
134255|NCT01810003|"~     Subclinical inflammation is now indisputably recognized as a key etiological factor in the~     development of atherosclerosis and subsequent cardiovascular disease. Obesity and related~     dysmetabolic states including metabolic syndrome (MetS) are highly prevalent causes of~     subclinical inflammation. Obesity and MetS are both diet and lifestyle-related and there is a~     growing body of literature suggesting that specific nutrients, such as long chain omega-3~     polyunsaturated fatty acids (LCn-3PUFA), may attenuate the pro-inflammatory state associated~     with these conditions. However, careful review of existing literature on this topic reveals~     important gaps in knowledge, the purported anti-inflammatory effects of LCn-3PUFA even being~     questioned by many. Significant confounding attributable to study design, sample size and~     biomarker selection may be responsible in part for inconsistencies in the literature on~     LCn-3PUFA and inflammation. We also found that evidence available to date (for and against)~     is based primarily on secondary analyses, as most of the studies published were not primarily~     designed to investigate inflammation as a primary outcome. It remains unclear whether the~     different LCn-3PUFA, primarily docosahexaenoic acid (DHA, 22:6n-3) and eicosapentaenoic acid~     (EPA, 20:5n-3), have similar effects on pro-inflammatory processes as almost all studies were~     undertaken using a mix of LCn-3PUFA. Whether efficacy of EPA and DHA is influenced by~     sex/gender is also unknown. Finally, a better understanding of the systemic and~     tissue-specific mechanisms underlying the anticipated anti-inflammatory effects of different~     LCn-3PUFA in MetS would also be of great value. Addressing these gaps has important public~     health implications, considering that LCn-3PUFA supplements are broadly and indiscriminately~     recommended for the prevention of cardiovascular disease.~      The overarching objective of the proposed research is to compare the anti-inflammatory~     effects of EPA and DHA in men and women with MetS.~   "
134256|NCT01809990|"~     The main goal of this trial is to study the feasibility and effectiveness of~     internet-delivered cognitive behavior therapy for adolescents with obsessive-compulsive~     disorder.~   "
134257|NCT01809977|"~     The purpose of this study is to determine which surgical method makes less corneal haze~   "
134258|NCT01809964|"~     The purpose of this study is to confirm the effect of ANT-1401 in the treatment of Lateral~     Canthal Lines.~   "
134259|NCT01809951|"~     The use of soy-isolate protein based formula for infants with cow's milk protein intolerance~     is common in Indonesia, however, there has not been any systematic collection of clinical~     data to determine the formula's gastrointestinal tolerance, and the parent's perceptions~     regarding the formula.~   "
134292|NCT01809522|"~     The present study is a multicenter randomized, controlled trial, whose aim is to verify the~     effect of the posterior reconstruction of the rhabdosphincter after robot-assisted radical~     prostatectomy on early recovery of urinary continence.~   "
134261|NCT01809925|"~     This is a randomized, double-blind, placebo-controlled, 2-treatment, 3-period crossover~     design study to evaluate the effects of psyllium 6.8 g provided as sugarfree Metamucil fiber~     supplement powder dissolved in water versus placebo on satiety measures in healthy~     volunteers. This study will be conducted at a single study site.~   "
134262|NCT01809912|"~     To investigate the safety and tolerability of a 28 day course of intravenous (IV) MG1102 in~     patients with solid tumors for which no standard therapy is available.~   "
134263|NCT01809899|"~     The overall goal of the proposed study is to insure the protection and safety of human~     subjects who have been previously exposed to interpersonal traumatic events and who are~     participants in symptom provocation research. The investigators intend to examine trauma~     history, cognitive, interpersonal, and genetic predictors of participants' unfavorable~     reaction to participation in research involving trauma-related script-driven imagery (SDI).~     The design includes comparing participants in a consent as usual group to participants in an~     enhanced consent group to see which minimizes unfavorable effects of participating in a~     research provocation study. In addition, the two different consent groups will be assessed~     for their effects on psychobiological and neurobiological stress response. Furthermore, the~     investigators will examine the relationship between the psychobiological responses and neural~     mechanism during SDI, and unfavorable reactions to participation in symptom provocation~     research.~   "
134264|NCT01809886|"~     The purpose of this clinical trial is to prove that the administration of sugammadex at a~     dose of 4 mg/kg for counteracting deep blockage [without train-of-four (TOF) ratio response~     and post-tetanic count (PTC) < of 2 induced and maintained with Rocuronium in pediatric~     patients for short-term elective surgery.~   "
134265|NCT01809873|"~     This project aims to test an innovative, sustainable financial incentive designed to reduce~     the number of non-malarial fevers that are treated inappropriately with antimalarial drugs.~   "
134266|NCT01809860|"~     The purpose of the study is to assess the effect of multiple doses of isavuconazole on the~     pharmacokinetics (PK) of sirolimus after single dose administration.~   "
134267|NCT01809847|"~     To study the safety and efficacy of anti-CD20 blockade with ofatumumab in the context of~     allogeneic HCT in CLL~   "
134268|NCT01809834|"~     Evaluation of two contact lenses~   "
134269|NCT01809821|"~     Sleep is an essential component of good physical and mental health. Previous studies have~     reported that poor quality sleep is associated with an increased risk of hypertension, stroke~     and cardiovascular disease (CVD). Hypertension is the most common and important risk factor~     for CVD, and even modest reductions in blood pressure result in significant reductions in~     stroke and myocardial infarction. In this randomised trial, the investigators aim to evaluate~     whether a simple, multi-component, online sleep intervention reduces blood pressure in~     patients with essential hypertension.~   "
134270|NCT01809808|"~     The purpose of this study is to evaluate hormone values and other markers of disease activity~     in a cohort of patients with acromegaly at the time of diagnosis and then prospectively after~     surgical or other treatment. This study is designed to determine blood levels of growth~     hormone and related hormones and cardiovascular risk markers as well as signs and symptoms of~     the disease at diagnosis and how these parameters change over time after surgical or other~     therapy. The investigators will also obtain hormonal data in a group of 50 healthy subjects~     who will each be studied just once with an oral glucose tolerance test (OGTT). These data~     will provide a comparison group to the acromegaly subjects.~   "
134271|NCT01809795|"~     The purpose of this study to determine if adding blueberries to obese children's diet will~     improve weight status and other medical testing. We would also like to determine if a larger~     research study involving blueberries is possible.~   "
134272|NCT01809782|"~     Cognitive outcome (delirium and post-operative cognitive deficiency) in patients undergoing~     two-time liver resection.~   "
134273|NCT01809769|"~     Two injections in total and 3 ml autologous adipose-tissue-derived stem cells(haMSCs) for~     each injection; time-points for intervention: 1) initial injection; 2) 3 weeks following~     initial injection.~   "
134274|NCT01809756|"~     Rationale: In the Netherlands 1731 people are being diagnosed with SCLC (Small Cell Lung~     Cancer) in 2010. This is approximately 14% of all new diagnosed lungcancers. Part of them~     will need a combination of chemo-radiationtherapy. A review of the incidence and severity of~     esophagitis in SCLC patients receiving a combination of chemotherapy and once daily~     radiotherapy revealed overall esophagitis rates up to 58% experiencing esophagitis grade 2~     and higher. As concurrent radiotherapy is moving to twice daily radiation (30 x 1,5 Gy in 3~     weeks) it is expected that the incidence of esophagitis will rise, the clinical symptoms are~     likely to arise earlier and become more severe.~      Mucositis of the upper tractus digestivus is a serious adverse event leading to pain,~     problems with swallowing and decreased food intake. It has a negative infect on QoL and can~     lead to prolonged hospital stay and delayed cancer treatment. Physicians seek improvements in~     treatment modalities to improve these daily patient toxicities.~      Caphosol® is an advanced electrolyte solution indicated as an adjunct to standard oral care~     in treating oral mucositis caused by radiation or high dose chemotherapy. Positive effects of~     Caphosol® oral rinse 4 times daily in a study with head and neck chemoradiation patients were~     found on the presence of mucositis and on oral comfort.~      It's supposed that the pathogenesis of chemo- or radiotherapy induced mucositis is the same~     for the whole tractus digestivus. The appearance does differ due to differences in cell~     proliferation.~      Swallowing Caphosol® after oral rinse could have a positive effect on esophageal mucositis on~     time of onset, severity and duration.~      Objective: Adding the use of Caphosol® (rinsing and swallowing four times a day) to the~     standard of care for esophagitis/mucositis, reduces the incidence, onset, duration and~     severity of esophagitis in SCLC patients, comparing to the standard of care alone.~      Study design: A multi-centre, open, randomized prospective phase II study. Study population:~     108 patients 18 years or older with histologically proven SCLC (all histological subtypes),~     treated with concurrent chemo- and radiotherapy are estimated to be included in this study~     (2:1 ratio inclusion; 72 patients with Caphosol® and 36 patients without Caphosol®; α=0.05,~     power 80%).~      Intervention (if applicable): 108 patients eligible for this study will be monitored during~     their SCLC chemo/radiotherapy treatment. One group of 72 patients will receive Caphosol®, 4~     times a day - next to the standard of care. Caphosol® will start at day 1 of treatment and~     will be continued until 3 weeks after the last radiotherapy (RT).Another group of 36 patients~     will receive only the current standard of care for esophagitis. The patients will be randomly~     assigned to one of the groups.~      Main study parameters/endpoints: The primary objective is to estimate the incidence, onset,~     duration and severity of esophagitis in SCLC patients undergoing radiation therapy with~     chemotherapy who receive Caphosol®.~      Secondary study parameters/outcome of the study (if applicable):~        1. To correlate components of esophagitis data with clinical outcomes (pain, dysphagia,~          analgetic use, oral intake, weight loss, infection, need for hospitalization, QoL)~        2. Discontinuation or delay of chemotherapy due to esophagitis. Nature and extent of the~          burden and risks associated with participation, benefit and group relatedness: The risks~          are very small. The patient has to fill in a Esophagitis Daily Questionnaire and during~          regular visits QOL questionaires are performed.~      Sputumswabs are collected on a weekly basis for determination of the microbiological flora of~     the mouth. During regular blood control max. 8 ml extra blood is taken for immunologic status~     research.~      Caphosol® is a saturated calciumphosphate solution. The daily intake of calcium and phosphor~     when swallowing Caphosol® 4 times daily is far beyond the Acceptable Daily Intake (ADI)(<~     5%). Compared to daily nutrients like milk (270 mg calcium per unit milk (225 ml)) or meat~     (200 mg phosphor per 100 g meat) the intake of calcium and phosphor due to Caphosol® is~     negligible and is considered safe.~   "
134275|NCT01809743|"~     The aim of the study is to test the accuracy of Regadenoson to induce maximal and steady~     state hyperemia as compared to central venous infusion of adenosine for assessing fractional~     flow reserve. (adenosine is considered to be the gold standard)and to investigate the time~     intervals of maximum hyperemia induced by centrally and peripherally administered~     Regadenoson.~   "
134276|NCT01809730|"~     This is a non-randomized, non-interventional pilot observational study designed to follow~     high-risk patients through their surgical and hospital stay. The investigators will collect 2~     4ml vial's of blood (total of 8ml) prior to surgery to assess CV biomarkers - inflammatory,~     metabolic, hypercoagulable and platelet.~   "
134277|NCT01809717|"~     This study will establich the feasibility of weight lifting exercise among patients with~     multiple myeloma, determine if weight lifting exercise increases lean body mass among~     patients with multiple myeloma and obtain further preliminary data on toxicity and~     pharmacokinetics of high-dose melphalan.~   "
134278|NCT01809704|"~     To demonstrate clinical substantial equivalence of DRI OCT-1 as comparable to the~     commercially available Cirrus~   "
134279|NCT01809691|"~     The purpose of this study is to compare overall survival in newly diagnosed metastatic~     prostate cancer patients randomly assigned to androgen deprivation therapy (ADT) + TAK-700~     versus ADT + bicalutamide.~   "
134280|NCT01809678|"~     This study examines the efficacy of yoga as a complementary therapy for smoking cessation~   "
134281|NCT01809665|"~     This investigation is designed to provide supporting evidence for the clinical safety of the~     Ilesto/Iforia ICD (implantable cardioverter-defibrillator)system and the Evia/Entovis HF-T~     (Heart Failure) triple chamber pacemaker system when used under specific MRI (magnetic~     resonance imaging) conditions.~   "
134293|NCT01809509|"~     Pilot study on molecular quantitation and sequencing of endometrial cytokines gene expression~     and their effect on the outcome of in-vitro fertilization (IVF) Cycle~   "
134294|NCT01809496|"~     The purpose of this study is to examine the effect of enhanced patient-centered counseling~     (PCC) and the influence of spousal involvement in pre-fitting counseling on hearing-aid~     outcomes.~   "
134282|NCT01809652|"~     The purpose of this study is to gain real world, live implant experience with the remote~     implant support system. This system is intended to provide the technical support for device~     implants from a remote location through telepresence (audio and video) and remote control.~     Specifically, the goals of this study are to corroborate bench testing, assess the~     performance of the system, gain understanding of the workflows, customer experience, and~     logistics.~      The intent of the remote support model is to provide the same support that would typically be~     provided by a local support person, only remotely. As such, the remote support person would~     only perform actions that a local support person would routinely do under the direction of a~     physician. This may involve observing patient data, providing technical support and advice,~     and performing testing and device reprogramming via remote control of the programmer.~   "
134283|NCT01809639|"~     Concussions are a common injury among athletes in the United States. The annual incidence of~     sports and recreational related traumatic brain injuries in the United States is 1.6 to 3.8~     million, and the likelihood of an athlete in a contact sport experiencing a concussion is as~     high as 20 percent per season. Even mild traumatic brain injury, including concussion, can~     cause long-term cognitive problems that affect a person's ability to perform daily activities~     and to return to school or work. Far more concerning is the mounting body of evidence that~     concussions are not just transient injuries - but have cumulative effects. It has been well~     established in animal models that progesterone has neuroprotective benefits. Animal studies~     using progesterone for acute post-injury treatment have demonstrated reduced cerebral edema,~     reduced neuro-inflammatory markers, decreased neuronal loss, and improved behavioral~     outcomes. To date, there have been no studies to assess whether or not progesterone will be~     effective for the treatment of concussions. This double-blind placebo controlled trial will~     assess the ability of 5 days of oral micronized progesterone (Prometrium®) to shorten the~     duration of symptoms of an athlete diagnosed with concussion. The investigators hypothesize~     that athletes treated with progesterone will have faster resolution of their concussive~     symptoms. The investigators believe this study may be the first clinical trial to show an~     effective treatment for concussion.~   "
134284|NCT01809626|"~     The primary goal of this single-blind, placebo-controlled, within-subjects, double-scan,~     one-visit neuroimaging study is to examine the effects of the hypnotic zolpidem (Ambien®) in~     individuals who are maintained on selective serotonin reuptake inhibitors (SSRIs) for the~     treatment of major depressive disorder. Specifically, levels of the brain chemical GABA will~     be examined in the anterior cingulate and thalamus, two brain regions that play important~     roles in mediating some of the effects of depression and sleep-related drugs, respectively.~     Depressed individuals typically have lower levels of GABA than the healthy population, and~     antidepressant treatment has been shown to help normalize this neurochemical in conjunction~     with improved mood. Given that individuals maintained on SSRIs often are prescribed~     sedative/hypnotics to treat concurrent insomnia, understanding a possible neurochemical~     interaction between them, whether beneficial or harmful, is important for informing~     evidence-based treatment strategies to treat the co-morbid patient. Zolpidem's effects on~     GABA in participants who are maintained on SSRIs will be compared to baseline GABA levels in~     these individuals (i.e., following placebo administration). Two separate scanning sessions~     lasting approximately 45-60 min each will take place within one single study visit in order~     to obtain these measurements using proton magnetic resonance spectroscopy (1H MRS). This type~     of neuroimaging is like an MRI in that it is non-invasive, but it permits us to obtain~     information about chemicals in the brain. A secondary goal of this study is to compare the~     subjective drug effects, or how individuals feel, following the intervention. These measures~     will be used to determine the existence of brain-behavior relationships in order to assess~     the extent to which modulating GABA with zolpidem has effects on mood states in depressed~     participants. Collectively, this study will contribute to our understanding of how these~     drugs exert their effects when one is administered in the presence of the other, and it will~     demonstrate that imaging is an important tool for informing us about how drug effects in the~     brain ultimately result in behavior.~   "
134285|NCT01809613|"~     This study is investigating the usefulness of using functional magnetic resonance imaging~     (fMRI) to monitor brain activation during deep brain stimulation for Parkinson's Disease,~     Essential tremor, dystonia, OCD, depression, pain, Tourette's syndrome, and epilepsy. The~     study may determine the relationship between patterns of brain activation and therapeutic~     outcome and/or side effects.~   "
134286|NCT01809600|"~     This retrospective study is aimed at evaluating the safety and efficacy of~     rituximab-containing immunochemotherapy in adult patients with Burkitt's lymphoma (BL) or~     high-grade B-cell lymphoma, unclassifiable, with features intermediate between diffuse large~     B-cell lymphoma and BL.~   "
134287|NCT01809587|"~     The purpose of the study is to evaluate the safety and efficacy of IQP-PO-101 in regulating~     the bowel movement frequency~   "
134288|NCT01809574|"~     We hypothesized that the multi-disciplinary assessment of interstitial lung disease patients~     would lead to a more accurate diagnosis and consequently alterations in treatment regimens~     that may lead to improved outcomes.~   "
134289|NCT01809561|"~     The purpose of the study is to assess the telomere array of different endometriosis tissue~     and endometrium from women with endometriosis compared to healthy women.~      Our hypothesis is that telomere shortening and high telomerase activity will be found in~     tissues from women with endometriosis.~   "
134290|NCT01809548|"~     Introduction: Preterm infants with a birth weight less than 1500 grams have special~     nutritional needs in comparison to full-term neonates. During their stay in the neonatal~     intensive care unit an increased supply with energy, protein and electrolytes is necessary to~     establish adequate growth. After discharge from the hospital special breast milk supplements~     or post discharge formulas are available to cover the special nutrient requirements.~     Complementary feeding in preterm infants is an unexplored field so far and nutritional~     concepts for the first year of life are not available. Data concerning the optimal time for~     starting solid foods are missing as well as information concerning the ideal composition of~     complementary food. In this context it is essential to meet the special nutritional needs of~     Ex-Preemies on the one hand and avoid overfeeding and later obesity on the other hand. So~     far it remains unclear, what the safe time point for introduction of solid food to~     premature infants is and whether this time point influences growth, body composition,~     neurodevelopmental outcome or the incidence of atopic disease.~   "
134291|NCT01809535|"~     Endoscopic variceal ligation (EVL) has proved to be effective in the prevention of esophageal~     variceal rebleeding. However, the optimal interval of EVL remains unclear. Our previous~     studies demonstrated that repeating EVL every 3-4 weeks could achieve an appreciable low~     incidence of variceal rebleeding and mortality. In our own opinion, many shallow post-EVL~     ulcers may hamper the performance of variceal ligation if EVL is performed at intervals of~     1-2 weeks. So far the optimal treatment interval remained unknown. The investigators~     hypothesis the Monthly EVL is superior to the Biweekly EVL in the prevention of esophageal~     variceal rebleeding in cirrhotic patients.~   "
134296|NCT01809470|"~     The study is investigating the metabolic response to playing competitive non-violent and~     competitive violent video games. The primary hypothesis is that the metabolic response in the~     violent game group will differ from the other two groups, due to activation of the stress~     response. The investigators are using an experimental approach, whereby 72 young men are~     randomised to one of three groups: watching television (TV), playing the non-violent video~     game 'FIFA2013', or playing the violent video game 'Call of Duty'. Participants arrive~     fasted, and are given a standardised breakfast. After measurements of weight, height and~     waist girth, they then are assigned to one of the three groups. Baseline blood pressure,~     heart rate and appetite/mood data are collected, along with a saliva sample for measurement~     of the 'stress' hormone, cortisol. The investigators will collect these data again at 4~     time-points during the one hour game-playing session. At the end of the study, the allow the~     participants half an hour of rest, during which they can choose from a variety of sweet or~     savoury snacks. The investigators will compare the data from the three groups, to test~     whether changes in blood pressure, heart rate and salivary cortisol, as well as snack~     consumption, are greater in the group playing the violent game.~   "
134297|NCT01809457|"~     to investigate the effectiveness of the educational poster regarding knowledge of dental~     trauma for the secondary school students~   "
134298|NCT01809444|"~     The aim of this study is to compare the efficacy and safety of prednisone versus~     sub-antimicrobial dose doxycycline (50 mg/d) in the treatment of active moderate-severe~     Graves' Orbitopathy (GO).~   "
134299|NCT01809431|"~     The purpose of this study is to determine whether a 14 week intervention is successful in~     improving outcomes for women with gestational diabetes mellitus and their infants.~   "
134300|NCT01809418|"~     The aim of the study is to test the hypothesis that a new device would produce a significant~     decrease in obstructive breathing events during sleep as indexed by the Apnea Hyperpnoea~     Index (AHI) or Respiratory Disturbance Index (RDI) and measures of oxygen saturation during~     sleep.~   "
134301|NCT01809405|"~     To validate the FSFI(Female Sexual Function Index)-K, FSFI - 6 item and Quality of Sexual~     Function(QSF) version in Korean language of the cancer patients.~   "
134302|NCT01809392|"~     Allo - hematopoietic stem cell transplantation is currently the only way to cure~     myelodysplastic syndrome /acute leukemia . The existing experimental results showed that~     decitabine and 5-azacytidine up-regulated the expression of tumor Ags on leukemic blasts in~     vitro and expanded the numbers of immunomodulatory T regulatory cells in animal models.~     Reasoning that decitabine might selectively augment a graft versus leukemia effect, the~     investigators used decitabine administration after allogeneic stem cell transplantation to~     studied the immunologic sequelae.~   "
134303|NCT01809379|"~     This trial aims to assess efficacy and safety of an intraperitoneal, aerosol, high-pressure~     chemotherapy in women with recurrent ovarian cancer~   "
134304|NCT01809366|"~     Seminal plasma insemination into the vaginal vault of patients undergoing IVF-ET increases~     uterine receptivity.~   "
134305|NCT01809353|"~     The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the~     drug) and safety of JNJ-54452840 in healthy participants.~   "
134306|NCT01809340|"~     The purpose of this study is to assess whether the antidepressant effect from intravenous~     (IV) ketamine treatment can be maintained by minocycline compared to placebo after IV~     ketamine treatment is stopped.~   "
134307|NCT01809327|"~     The purpose of this study is to assess the effectiveness of the co-administration of~     canagliflozin and metformin extended release (XR) compared with canagliflozin alone, and~     metformin XR alone in patients with type 2 diabetes mellitus with inadequate control despite~     treatment with diet and exercise. The safety and tolerability of canagliflozin will also be~     assessed.~   "
134308|NCT01809314|"~     This observational study will evaluate the efficacy and safety of epoetin beta (NeoRecormon)~     in participants with symptomatic anemia and cancer receiving chemotherapy. Participants~     receiving NeoRecormon once weekly in accordance with the Summary of Product Characteristics~     will be followed for 4 months.~   "
134309|NCT01809301|"~     The objective of this study is to compare the absorption of a niacin metabolite~     (1-methylnicotinamide, 1-MNA) from TRIA-662 (1-methylnicotinamide chloride)relative to the~     production of 1-MNA from Niaspan. The 1-MNA information obtained from this study will be used~     to adjust the top dose of a planned TRIA-622 efficacy study.~   "
134310|NCT01809288|"~     Background:~      - Rates of diabetes and heart disease in women are increasing. Early recognition of risk~     could help women live longer and healthier lives. Race and ethnicity may affect the best~     kinds of tests to use to screen for these conditions. Researchers want to compare risk~     factors for diabetes and heart disease in African, African-American, and white women. Doing~     so may help identify the most effective screening test for each group. This study will look~     at healthy African, African-American, and white women who are federal employees and~     contractors.~      Objectives:~      - To study risk factors for diabetes and heart disease in African, African-American, and~     white women.~      Eligibility:~        -  Healthy African, African-American, and white women between 30 and 65 years of age who~          are federal employees or contractors.~        -  For this study, African women must be born in Africa and have immigrated to the United~          States, and report that both parents are Africans. African-American women must~          self-identify as African-Americans, born in the United States, and have parents who both~          self-identify as African-American born in the United States. White women must~          self-identify as white and have parents who also self-identify as white.~      Design:~        -  Participants will have four visits to study their risk factors for diabetes and heart~          disease.~        -  The first visit is a screening visit. Participants will be screened with a physical exam~          and medical history. Blood and urine samples will be collected. They will also have an~          EKG test. Participants will also be shown how to fill out a 3-Day Food Record and wear~          an activity monitor called an accelerometer. The food record will keep track of how much~          participants eat for 3 consecutive days, including 1 non-working day. The accelerometer~          device will be worn for 3 days to monitor movement.~        -  At the second visit, participants will have blood tests, an oral glucose tolerance test,~          and body fat measurements. They will also fill out questionnaires, review the food~          record, and have two imaging studies.~        -  At the third visit, participants will have a longer glucose tolerance test. During the~          test, participants will receive both glucose and insulin and blood samples will be~          collected over several hours. Participants will receive lunch at the clinical center~          after the test.~        -  At the fourth visit, participants will have a meal test. They will fast for 12 hours~          before the test. Participants will eat a specific meal and have blood samples taken~          during and after they eat.~        -  Participants will discuss the results of these tests with the study doctors.~   "
134311|NCT01809275|"~     The purpose of this study is to evaluate the safety profile and to obtain an indication as to~     the therapeutic effect of QBECO induction treatment on clinical improvement in moderate to~     severe Crohn's Disease.~   "
134312|NCT01809262|"~     Primary objective: To investigate bronchodilator effect and safety of single doses of BI 1744~     CL inhaled via Respimat inhaler, Secondary objective: to characterize pharmacokinetics of BI~     1744 CL. Olodaterol dose 40 mcg was investigated only in the open-label extension part for~     additional PK assessments which are not defined as primary or secondary endpoints.~   "
134313|NCT01809249|"~     Due to absence of Deceased-donors in Egypt, Living-donor liver transplantation (LDLT) has~     emerged as an option to the traditional deceased-donor transplantation procedure. But there~     is an essential risk related to liver resection for healthy donors.~   "
134314|NCT01809236|"~     This is a Phase II, single arm, open label clinical trial. 60 RVO patients (including 30 BRVO~     and 30 CRVO, respectively) are enrolled in the study. The study included a fixed treatment~     period (3 months) and a PRN period (6 months). In the fixed treatment period patients will~     receive 3 consecutive monthly intravitreal of 0.5 mg Conbercept. In the PRN period, patients~     are monthly visited and retreatment will be needed according to the retreatment criteria~     pre-specified.~   "
134315|NCT01809223|"~     This study is design to evaluate the effect of conbercept therapy on visual acuity and~     anatomic outcomes compared to sham injection and durability of response observed in subjects~     with choroid neovascularization secondary to pathological myopia.~   "
134316|NCT01809210|"~     This is a Phase I, open label multicentre study of selumetinib administered orally in~     combination with first line chemotherapy regimens to patients with advanced/metastatic NSCLC.~     The study has been designed to allow an investigation of the optimal dose of selumetinib in~     combination with various standard first line double-platinum chemotherapy regimens. Initial~     assessment will be based on tolerability of selumetinib in combination with one or more~     selected regimens that are considered to be tolerated also being assessed for preliminary~     evidence of activity.~      This study is a dose finding and optional cohort expansion; In addition all patients will be~     assessed for anti-cancer efficacy of the combination of selumetinib and chemotherapy.~   "
134317|NCT01809197|"~     The purpose of this study was to compare lens comfort on Day 30 for Air Optix® lenses cared~     for with OPTI-FREE® PureMoist® (OFPM) Multi Purpose Disinfecting Solution (MPDS) compared to~     Acuvue® Oasys® lenses cared for with habitual MPDS.~   "
134318|NCT01809184|"~     This trial is conducted in Europe. The aim of this first human dose trial is to investigate~     the safety, tolerability, pharmacodynamic (the effect of the investigated drug on the body)~     and pharmacokinetic (exposure of the trial drug in the body) properties of NNC0148-0000-0287~     (insulin 287) in a GIPET® I tablet formulation in healthy subjects.~   "
134319|NCT01809171|"~     The third generation oral aromatase inhibitors (AIs) are increasingly being used in the~     management of estrogen receptor positive breast cancer. One of the issues related with~     administration of oral AIs is their side effects, particularly on the musculoskeletal system.~     Although the prevalence and importance of arthralgia and myalgia occurring in BC patients~     receiving adjuvant AIs are evident, the mechanisms clearly explaining these invalidating~     symptoms are unknown.~      In this project, we aim to unravel the interaction between vitamin D and musculoskeletal~     adverse events experienced by AI users. We will also evaluate how vitamin D supplementation~     affects AI-induced musculoskeletal symptoms in breast cancer patients, by means of a~     randomized placebo-controlled double blind clinical trial. We will assess changes in the~     musculoskeletal system by using magnetic resonance imaging of joints, hand grip strength and~     also monitor serum IGF-I and estrogen levels together with bone resorption and formation~     markers.~   "
134320|NCT01809158|"~     Schizophrenia is understood to be a heterogeneous brain condition with overlapping symptom~     dimensions. The negative symptom dimension, with its protean cognitive manifestations,~     responds poorly to treatment, which can be a particular challenge in countries where~     clozapine therapy is not available. Preliminary data indicates that minocycline may be~     beneficial adjunct in the treatment of schizophrenia: positive, negative, and cognitive~     symptoms. Persons with schizophrenia or schizoaffective disorder and recent onset~     schizophrenic episode or recent relapse who are prescribed minocycline in addition to~     standard antipsychotic medication will show greater symptom reduction, as measured by the~     Positive and Negative Syndrome Scale (PANSS) total score.~   "
134321|NCT01809145|"~     The purpose of this study is to apply the MELISA test, that diagnose hypersensitivity to~     metals, in Sarcoidosis patients with occupational exposure.~   "
134322|NCT01809132|"~     This study will compare two different treatments of acute alcoholic hepatitis. The current~     standard of care is treatment with corticosteroids (methylprednisolone). This will be~     compared to treatment with anakinra, pentoxifylline, plus zinc sulfate. The participants will~     be treated and followed for 6 months and the two treatment groups will be compared for~     differences in death rates and laboratory tests that measure liver and gut function.~   "
134323|NCT01809119|"~     Partial nephrectomy is considered the standard treatment for renal tumors smaller than 7 cm.~     With the evolution of image diagnostic tools and dissemination of its use, smaller tumors are~     being commonly diagnosed and treated. The partial open nephrectomy is still considered the~     gold standard technique for nephron sparing surgery, especially when the surgeon is not~     experienced with the minimally invasive surgery. In the last 15 years, uncountable minimally~     invasive techniques were developed, including the laparoscopic partial nephrectomy. The~     objective of this study is compare the partial laparoscopic nephrectomy to open partial~     nephrectomy in terms of perioperative, oncologic and functional outcomes. A balanced~     randomized prospective trial will be conducted. One group of patients will be submitted to to~     open partial nephrectomy while the other group of patients will be submitted to laparoscopic~     partial nephrectomy. A randomized prospective trial comparing the two techniques is necessary~     to determine the differences in outcomes between them and if the laparoscopic partial~     nephrectomy can be performed without harms to the patients.~   "
134333|NCT01808989|"~     The measurement of the transcutaneous oxygen pressure records simultaneously the tcpO2 at the~     buttocks and chest level during walking. Before and after exercise the diagnosis,~     investigations and treatments ongoing or to be performed are recorded.~      The present study focuses on the clinical interest of the transcutaneous oxygen pressure~     during exercise in the diagnosis of claudication in patient referred for an oximetry exercise~     test.~   "
134346|NCT01808807|"~     To elucidate the audit's effect on caesarean section rate, and also define the factors~     influencing the caesarean section rate.~      From Jan 2007 , pregnant women who delivered in a medical center will be included~     retrospectively in this study. Our monthly cesarean section audit, focusing on discussing the~     indications of cesarean section, began from July 2008. Clinical data, indications of cesarean~     section, and perinatal outcomes were compared between the cases of before and after the~     audit. Multivariate logistic regression was performed to identify factors affecting cesarean~     section rate.~   "
134878|NCT01801865|"~     The purpose of the present study is to make medically indicated state of the art/high end~     magnetic resonance imaging (MRI) exams available to all infants in the Cincinnati Children's~     Hospital Medical Center (CCHMC) Neonatal Intensive Care Unit (NICU).~   "
134324|NCT01809106|"~     Pain, in neoplastic disease, is a symptom with severe negative impact on the quality of life~     of patients and a high incidence, with values around 70-90% in advanced and metastatic~     stages. Than 20 years the main reference for the pharmacological treatment of cancer pain are~     the guidelines produced by the World Health Organization (WHO). This document shows that the~     use of opioid drugs is the mainstay of treatment, with particular reference to opioids~     major (3 rd step of the analgesic ladder). The 4 opioids more most commonly prescribed in~     Italy (oral morphine and oxycodone, fentanyl and buprenorphine transdermal), based on the~     data currently available, have an analgesic effect would partly overlap but with different~     percentages of non-responders (NR), a different need to increase the dose over time to~     maintain adequate analgesia, a different action to the switch to another molecule for~     ineffectiveness analgesic. The observations described suggest that opioids, although they~     belong to the same family drug may not be fully comparable with regard to the clinical~     effects products. Important differences are known on the pharmacokinetic and pharmacodynamic~     and, more recently, also in terms of pharmacogenomics. This is a comparative study of~     analgesic strategies based on the use of the 4 mentioned opioids, going to look for possible~     differences in terms of analgesic efficacy, changes in dose over time, use of switch or~     permanent abandonment of treatment, parallel to the contour of the side effects. The~     associated sub-project will link the structure gene of patients and clinical results have~     emerged.~   "
134325|NCT01809093|"~     You are being asked to be in a research study to determine blood levels and vitreous levels~     of compounds called thrombospondin 1 (TSP1) and pigment epithelium derived factor (PEDF).~     These compounds exists naturally in your body.~   "
134326|NCT01809080|"~     Retrospective studies have established a strong correlation between reports of life stress~     and depression. Investigators have begun to further explore this relationship by examining~     the role of gene x stress interactions in the pathogenesis of depression. In a recent~     landmark study, Caspi and colleagues (2003) reported an interaction between a serotonin~     transporter promoter polymorphism and life stress in the development of depression. This~     finding has been replicated in some but not all follow up studies. Despite the initial~     promise of these results, the ability to draw definitive conclusions is compromised by~     significant study design limitations: 1) retrospective design 2) a focus on acute rather than~     chronic stress 3) substantial variation in the character and intensity of stress between~     subjects. Medical internship is a period filled with predictable and high levels of chronic~     uncontrolled stress. Rates of depression among interns are elevated compared to the general~     population. In this study, we aim to utilize the predictable and consistent stress of~     internship to investigate the relationship between stress, genes and depression with a~     prospective study design that bypasses some of the pitfalls of previous studies.~   "
134327|NCT01809067|"~     Research Question:~      What effect if any does the use of lavender aromatherapy have on a patient's stress and~     anxiety during the MRI procedure in the Cardiovascular Services Department?~      Hypothesis:~        1. The use of lavender aromatherapy will reduce anxiety by 20% during MRI procedures.~        2. MRI cancellations related to stress and anxiety will decrease by 10%.~      Sample size of 30 patients is needed for the control group and the lavender aromatherapy~     group, for a total of 60 patients.~      Rationale:~      Patients undergoing MRI procedures may experience stress and anxiety related to the small and~     confining space required during the scan. Anyone with a history of claustrophobia, panic~     attacks, or fear of enclosed spaces is more likely to experience symptoms of panic, fear, or~     anxiety during the MRI procedure (Harris, Cumming, & Menzies, 2004, p. 1). This stress and~     anxiety may cause the patient to abort the scan, the patient may refuse future scans, or the~     patient's nervous tremors or involuntary quivering may adversely affect the images obtained.~     Lavender aromatherapy has been shown to reduce stress and anxiety for patients in other~     settings; however, its use during MRI procedures has not been studied.~      This project investigates the use of lavender aromatherapy as a non-pharmacological way to~     help patients relax during their MRI procedure. Lavender aromatherapy has been studied and~     shown to reduce stress and anxiety for patients in other situations, but it has not been~     studied during MRI procedures. Lavender is known to be uplifting, as well as soothing and~     helpful for reducing stress, anxiety, depression, and insomnia (Herz, 2007, p. 264). If~     aromatherapy proves useful as an agent to reduce stress and anxiety, patient satisfaction~     with their MRI procedure will increase and the need for sedating medication could decrease.~   "
134328|NCT01809054|"~     This is a prospective, randomized study from pre-surgery to 6 weeks post-surgery designed to~     detect changes in coagulability following elective total knee and hip arthroplasty. Patients~     will be randomized to one of the two standard prophylaxis treatments used at Sinai Hospital:~        1. Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325~          mg for 5 weeks, or~        2. Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc.,~          Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.~   "
134329|NCT01809041|"~     Post-operative cognitive dysfunction (POCD) is a fairly well-documented clinical phenomenon.~     Most patients will receive general anesthesia during surgery. Two groups of general~     anesthetics are used for this purpose. We hypothesize that the incidence of POCD is not~     different in patients received intravenous anesthetics only or sevoflurane (a volatile~     anesthetic-based general anesthesia) for their major intra-abdominal surgery.~   "
134330|NCT01809028|"~     This study will test the amount of tissue, called cell block, obtained from your pancreas.~     Patients who are asked to participate in this study have a growth (mass) in the pancreas that~     needs a biopsy so a diagnosis can be made. Although we usually perform 2 to 4 passes (number~     of times the doctor biopsies the mass), at this time we do not know the ideal number of~     passes needed to obtain adequate amount of tissue for making a diagnosis. The purpose of this~     study is to compare the amount of tissue obtained with 2 passes versus 4 passes.~   "
134331|NCT01809015|"~     Since decades, oral anticoagulation (OAC) with vitamin K antagonists (VKA) is an established~     therapy for both prevention and treatment of thromboembolism in daily clinical routine.~     Increasing life-expectancy, the demographic change and novel oral anticoagulants lead to an~     increasing complexity of medical therapy. However, data on quality and management of VKA~     therapy with phenprocoumon in current medical care are limited. Our aim was to investigate~     the quality of OAC with VKA in current health care and to evaluate the potential for~     improvements.~      The investigator-initiated thrombEVAL study program comprises two cohorts of patients treated~     with vitamin K antagonists for oral anticoagulation therapy in real-life settings: a~     multicentre cohort of patients in regular medical care and a multi-local, single centre~     cohort of patients in a telemedicine-based coagulation service. The study program is expected~     to enrol a total number of approximately 2,000 to 2,500 patients. Both cohorts build on a~     detailed clinical assessment of participants and anticoagulation therapy at study enrolment.~     Subsequently active and passive follow-up investigations are carried out to document and~     validate complications of the treatment. Primary short-term outcome is the distribution of~     time in therapeutic range; the primary long-term outcome comprises the composite of stroke,~     systemic embolism, myocardial infarction, major and clinically-relevant bleeding and death.~   "
134334|NCT01808976|"~     Over two million people in the US download health apps onto their smartphones and tablets,~     with the intent of improving their quality of life. Despite widespread use of these apps,~     there is relatively little information regarding app user access (do users download health~     apps and use them more than once), app user engagement (do users follow the app protocols)~     and app impact on mood, cognition and daily functioning. Our long-term goal is to conduct a~     future randomized controlled trial investigating access, engagement and impact of two types~     of mental health apps, apps based on evidence-based therapeutic principles (i.e.: Problem~     Solving Therapy) and apps based on cognitive neuroscience principles of depression (i.e.: a~     cognitive training game called Evolution) and compare both to an information only app. Our~     intent is to conduct this study entirely on mobile devices, in order to investigate access,~     engagement, and impact in an ecologically valid manner. The purpose of this pilot study is to~     test the feasibility of conducting our future randomized controlled trial comparing three~     mobile mental health apps for the management of depressed mood, improvement of cognitive~     control, and improvement in activities of daily living in people aged 18 and older.~     Recruitment, consent, randomization, app use and outcome assessment will be conducted~     entirely on mobile devices. We will recruit 150 people through four different recruitment~     avenues to determine which avenue results in the most representative sample of our target~     population (people 18 and older who have symptoms of depression that are interfering with~     their quality of life). We will also determine the number we need to recruit to have a final~     sample of 150 people willing to be randomized between the 3 apps and complete an 12-week~     study of app impact on mood, cognition and function. This pilot will provide information on~     the completeness of data from a study conducted in this manner, and uncover any other~     challenges we may face by using mobile devices for data collection, and if we will find~     differential drop out between app type (e.g.: will more people stop using of the information~     only app prematurely?). Although we will not have sufficient statistical power to answer~     questions about comparative effectiveness between the apps, we plan to explore relationships~     between sample demographics, app use, and improvement in cognitive control on improvements in~     mood and function.~   "
134335|NCT01808963|"~     To evaluate the utility of respiratory heat loss measurements as a physiologic monitor.~   "
134336|NCT01808950|"~     The primary objective is the observation and description of the preliminary efficacy of~     resiquimod gel 0.06% on a single nodular basal cell carcinoma (nBCC) in a small group of~     patients.~   "
134337|NCT01808937|"~     The Morphea in Adults and Children (MAC) cohort is the first registry for both children and~     adults with morphea (also known as localized scleroderma) in the country. The purpose of the~     registry is to learn more about morphea, specifically:~        -  How morphea behaves over time~        -  How frequently specific problems occur along with morphea (for example, arthritis)~        -  Whether morphea has an autoimmune background~   "
134338|NCT01808911|"~     CREHA project is a study comparing steroid combined with cyclophosphamide versus steroid~     combined with rituximab in patients with acquired haemophilia. The study will test the~     hypothesis that steroid combined with cyclophosphamide is more effective than steroid plus~     rituximab for FVIII inhibitor eradication in acquired haemophilia.~   "
134339|NCT01808898|"~     The usual intervention to control the pain during an outpatient endometrial ablation has been~     to use local anaesthesia (LA) injection just in the neck of the womb (cervix). However, this~     alone may not be sufficient to control the pain completely. Therefore, we want to find out~     whether an injection of LA given deep into the muscle of the womb (myometrium), in addition~     to that in the cervix, has a better effect on controlling the pain during the procedure.~      All women attending gynaecology outpatient clinics, who have consented for an outpatient~     hysteroscopic procedure, will be invited to take part in the study. The study will be carried~     out in the outpatient hysteroscopy clinic at Birmingham Women's Hospital.~      As part of standard pain control method during an outpatient endometrial ablation, all women~     will receive an injection of LA in the cervix of the uterus to 'freeze it'. During~     hysteroscopy a randomly selected treatment group will receive an injection into deep muscle~     containing only normal saline (control group) whereas the experiment group will receive fast~     / long acting local anaesthesia (cornual block).~      Women will be asked to rate the degree of pain by placing a mark on an ungraduated 10 cm~     horizontal line. These scales will be given before the procedure, during LA injection,~     immediately after, one hour and at the time of discharge from hospital.~      The results will help future patients undergoing a similar procedure to have much better pain~     relief and allow many more to have the procedure without the side effects of a general~     anaesthetic and its risks. In addition to having less pain, it may reduce the number of~     painkillers needed as well as any stay in hospital. In future this may also allow a greater~     variety of procedures to be done in an outpatient setting.~   "
134340|NCT01808885|"~     This is a 24-week phase 1b, randomized, double-blind, placebo-controlled, parallel-group,~     multicenter safety study comparing the tolerance profile of olesoxime (495 mg, od) when~     administered on top of Interferon beta in patients with stable Relapsing Remitting Multiple~     Sclerosis. Patients will be randomly allocated to olesoxime (495 mg, od) or placebo in a 1:1~     ratio.~   "
134341|NCT01808872|"~     The AQT90 FLEX B-type Natriuretic Peptide (BNP) and N-terminal pro B-type natriuretic peptide~     (NT-proBNP) Tests are in vitro diagnostic assays intended as an aid in the diagnosis and~     assessment of the severity of heart failure in point-of-care and laboratory settings. The~     purpose of the study is to establish the clinical performance of the AQT90 FLEX BNP and~     NT-proBNP assays for both whole blood and plasma in the intended use population.~   "
134342|NCT01808859|"~     The purpose for this study is to investigate the quadriceps (thigh) function preoperatively~     and 48 hours postoperatively during knee arthroplasty (total replacement of the knee joint)~     in a randomised study with or without the use of a Tourniquet (cuff around the thigh during~     surgery) (100 mm Hg > systolic blood pressure).~   "
134343|NCT01808846|"~     To explore whether obese adolescents with insulin resistance and relative low leptin levels~     exhibit functional alterations of the neuronal circuits involved in the regulation of energy~     metabolism and food seeking behaviors.~      We here propose to test the hypothesis that the reward circuitry is dysregulated in obese~     adolescents and is related to the degree of insulin resistance and hyperinsulinemia.~   "
134344|NCT01808833|"~     The investigators hypothesize that frailty assessment prior to concurrent chemotherapy and~     radiation therapy in the elderly will predict treatment-related toxicity and morbidity and~     that such assessment at serial time points will help improve treatment and outcomes for these~     patients.~   "
134345|NCT01808820|"~     Dendritic Cell vaccine manufactured and partially matured using our standard operating~     procedures, developed in collaboration with the HGG Immuno Group, then administered through~     imiquimod treated skin will be safe and feasible in patients with high grade glioma. This~     will result in anti-tumor immunity that will prolong survival of subjects treated. Study~     treatment will correlate with laboratory evidence of immune activation.~   "
134365|NCT01808560|"~     The purpose of this pilot feasibility study is to assess whether treating meibomian gland~     dysfunction (MGD) prior to cataract surgery helps promote meibomian gland function, visual~     quality and ocular comfort after cataract surgery.~   "
134347|NCT01808794|"~     The purpose of the study is to compare one material called Mucograft with another material~     called Dynamatrix. These materials are used as a type of a barrier (made from pig material~     also known as porcine material) in a preservation technique to increase the thickness and~     width of tissues at a tooth extraction site. The investigators want to see if one works~     better than the other or if they work equally as well. These materials are made up of~     collagens, which are naturally occurring proteins found in the skin, specifically connective~     tissue. Dynamatrix is made up of many types of collagens whereas Mucograft is only made of~     fewer collagens. These materials have been given something called a 510(k) status by the FDA.~     This means that the FDA determines them to be equivalent to another product that they have~     previously approved. You will be put into one of two groups at random, and will not know~     which one you are in. Like flipping a coin, you will have a 50/50 chance to be in either one~     of the two groups. You will either be in a group using Mucograft or in a group using~     Dynamatrix. Both of these materials are regularly used in the dental clinics.~   "
134348|NCT01808781|"~     The purpose of this study will be to find out the effect of two different interventions on~     muscle strength, ability to produce muscle force quickly (power), daily function, and number~     of steps and physical activity an individual with total knee replacement do daily.~      The research hypotheses for this study will be as follows:~        -  For individuals who are at least 6 months post-total knee replacement, home-based~          high-velocity training exercises will result in significantly greater improvements in~          muscle strength and power compared to those who receive a walking program only.~        -  For individuals who are at least 6 months post-total knee replacement, home based~          high-velocity training exercises will result in significantly greater improvements of~          daily function(eg. sit to stand, climb a set of stairs)than those who receive a walking~          program only.~        -  For individuals who are at least 6 months post-total knee replacement, home based~          high-velocity training exercises will result in significantly greater improvements in~          physical activity behavior (eg. number of steps per day)compared to those who receive a~          walking program only.~   "
134349|NCT01808768|"~     To study the impact of alcaftadine in patients treated with other opthalmic ocular agents (or~     specific topical opthalmic treatment) in an allergy subspecialist outpatient setting.~   "
134350|NCT01808755|"~     Background- In recurrent urinary tract infections (RUTIs) usual prophylactic antibiotic~     regimes do not change the long term risk of recurrence.~      Objective- D-Mannose is a sugar, it sticks to E. coli bacteria, the aim of the study was to~     evaluate its efficacy in the treatment and prophylaxis of recurrent UTIs.~      Design, setting and participants- : In this crossover trial female patient were eligible for~     the study if they had recurrent UTIs, that is three ore more episodes during the preceding 12~     months. Suitable patients were randomly assigned to antibiotic treatment with~     trimethoprim/sulfamethoxazole or to a regimen of oral D Mannose for 24 weeks, and received~     the other intervention in the second phase of the study.~      Outcome measurements and statistical analysis- The time to recurrence of UTI, bladder pain~     (VAS p) and urinary urgency (VAS u) were evaluated at the end of antibiotic therapy and at~     the and of 24 weeks fo D Mannose. The results for quantitative variables were expressed as~     mean values and SD as they were all normally distributed (Shapiro-Wilk test). T-test for~     paired data was used to analyze differences of time of recurrence, VAS pain, Vas urgency and~     number of voidings between treatment. Data analysis was performed with STATA statistical~     package (release 11,1, 2010, Stata Corporation, College Station, Texas, USA).~   "
134351|NCT01808742|"~     myoscience Inc. (Redwood City, CA) has developed a device for a novel, minimally invasive~     facial rejuvenation procedure designed to soften hyperdynamic facial lines. The myoscience~     Cryo-Touch III device uses well-established principles of cryobiology to cause localized~     reduction in muscle activity resulting in a reversible reduction in facial animation and the~     appearance of facial lines. The device operates on well-established cryobiology principles;~     that localized exposure to controlled low temperature conditions can alter tissue function.~     The therapy treats targeted motor nerves with low temperatures via a cold probe in the form~     of an assembly of small diameter needles, creating a highly localized treatment zone around~     the probe. The thermal algorithm is designed to produce a reversible loss of nerve conduction~     resulting in a temporary decrease in muscle contractility. Prior studies of Cryo-Touch,~     Cryo-Touch II and Cryo-Touch III have provided strong evidence of effectiveness and safety~     for applications in this indication. The goal of the study described herein is to investigate~     optimized algorithms and ongoing safety and effectiveness.~   "
134352|NCT01808729|"~     The purpose of this project is to see if heritable alterations in the function, biology and~     vascular repair capacity of vascular cells make a major contribution to the burden of~     coronary artery disease (CAD), fibromuscular dysplasia (FMD), and other vascular diseases.~      In more detail, FMD is a nonatherosclerotic vascular disease that primarily affects women~     aged 20 to 60. It commonly affects the renal and carotid arteries but may involve almost~     every artery in the body. At the cellular level, FMD is characterized by increased fibroblast~     proliferation and collagen deposition. This study aims to define some of these cellular~     problems by directly studying fibroblast cells from FMD patients and healthy control~     subjects. Similarly, CAD is among the leading causes of death worldwide. However, a large~     part of the risk for CAD is unexplained. It is thought that a major but undefined risk factor~     may be gene (genomic) variations causing a change in vascular cell function. Here, we will~     study important vascular cell types in patients with severe and early onset CAD in an attempt~     to define these problems. Therefore, in summary, this study will look to define the various~     cellular-level problems that occur in patients with both in CAD and FMD. These data will be~     linked to DNA-level analyses to ultimately attempt to define the cause of these conditions.~   "
134353|NCT01808716|"~     The study hypothesis is a decreased muscle damage induced by exercises when low-level laser~     therapy is applied on body muscles before exercises.~   "
134354|NCT01808703|"~     The purpose of this study is to determine if a topical, adhesive patch (PeriZone PerioPatch)~     applied to the gums after a deep tooth cleaning (scaling and root planing) reduces the signs~     of advanced gum disease (chronic periodontitis) more than the deep tooth cleaning alone.~     Eighty patients with advanced gum disease will be recruited and treated within this clinical~     trial. Patients will be evaluated for changes in gum measurements over a 12-week period.~   "
134366|NCT01808547|"~     The purpose of this study is to evaluate the ocular safety, tolerability and efficacy of~     topical administration of ISV-303 compared with Durasite Vehicle.~   "
134355|NCT01808690|"~     Diabetes is increasingly common among youth, forecasting early complications. Type 1 (T1D)~     cause early heart disease, shortening lifespan despite modern improvements in control of~     blood sugars and other risk factors for heart disease. Poor insulin action, otherwise known~     as insulin resistance (IR), is the main factor causing heart disease in type 2 diabetes~     (T2D), but the cause of increased heart disease in T1D is unclear. IR may contribute to heart~     disease in T1D as in T2D, as the investigators and others have found the presence of IR in~     T1D. Much less is known about IR in T1D, but a better understanding of its role in T1D is~     critical to understanding causes of heart disease in T1D. The investigators long-term goal is~     to understand the early causes of heart disease in diabetes so that we can prevent it. The~     investigators unique initial findings suggest that even reasonably well-controlled, normal~     weight, T1D youth are IR. The IR appears directly related to the heart, blood vessel, and~     exercise defects, but in a pattern that appears very different from T2D. The goals of this~     study are to determine the unique heart, blood vessel and insulin sensitivity abnormalities~     in T1D youth, and determine whether metformin improves these abnormalities. A clear~     understanding of these factors will help determine the causes, and what treatments could help~     each abnormality.~      Hypothesis 1: Metformin will improve insulin function and mitochondrial function in T1D.~      Hypothesis 2: Metformin will improve vascular and cardiac function in T1D.~      All measures will be performed twice, before and after a 3-month randomized,~     placebo-controlled design where subjects are randomized to either metformin or placebo. The~     independent impact of insulin action as well as glucose levels, BMI, T1D duration, and gender~     on baseline outcomes and the impact of changes in insulin action, glucose levels and BMI on~     response to metformin will also be examined to help customize future strategies to prevent~     heart disease in T1D. This study will advance the field by providing new information about~     the role of poor insulin action in the heart disease of T1D, and whether improving insulin~     action in T1D is helpful. If a focus on directly improving insulin action in T1D youth is~     supported by our studies, the clinical approach to T1D management may significantly change.~   "
134356|NCT01808677|"~     The goal of this research study is to learn more about the safety of treating NSCLC with~     reirradiation using standard methods and to look for ways to lessen side effects and improve~     therapy. Reirradiation is when radiation is given to an area of the body that has previously~     received a full dose of radiation.~   "
134357|NCT01808664|"~     In this study, the investigators will develop and evaluate a novel intervention using~     standardized patients (SPs) -- or actors playing the roles of patients -- to enhance~     physicians' patient-centered counseling skills regarding two frequently overused, potentially~     inappropriate services in primary care: magnetic resonance imaging (MRI) for acute low back~     pain and bone densitometry in women at low-risk for osteoporosis. The investigators will~     further evaluate whether intervention effects on physician patient-centeredness generalize to~     counseling regarding other costly, unnecessary diagnostic tests.~   "
134358|NCT01808651|"~     This study will evaluate the safety and effectiveness of fluoxetine flexible dosing in the~     treatment of MDD in adult Japanese participants.~      Participants who complete the short-term treatment phase of Study B1Y-JE-HCLV (NCT#:~     NCT01808612) will be allowed to enroll in this study, and receive fluoxetine treatment for an~     additional 52 weeks.~   "
134359|NCT01808638|"~     The purpose of the study is to evaluate a new treatment strategy for advanced pancreatic~     cancer disease by combining the new investigational medicinal product Atu027 with the~     standard chemotherapeutic gemcitabine. This combination aims at enhancing gemcitabine´s~     anti-tumor activity with Atu027.~      The objectives of this clinical trial are to evaluate safety and activity of two Atu027~     schedules in combination with standard gemcitabine treatment in patients with advanced or~     metastatic pancreatic adenocarcinoma.~   "
134360|NCT01808625|"~     Radiotherapy is the mainstay of treatment for brain malignancies and is associated with~     significant neurotoxicity. Due to continuous increase in patient's survival, the long term~     risk for radiation-induced brain inflammation and necrosis inducing secondary cognitive~     impairments are increasing concerns. Currently there is no effective treatment for preventing~     long term radiation-induced brain damage.~      Hyperbaric oxygen therapy (HBOT) is the administration of high oxygen concentrations within a~     pressurized chamber to increase the cellular/mitochondrial delivery of oxygen. Oxygen~     stimulation by HBOT has become the definitive therapy for radiation-induced damage to soft~     tissues and bone due to its ability to stimulate healing processes by supplying the~     energy/oxygen needed while down-regulating genes involved in inflammation. Oxygen stimulation~     by HBOT is currently indicated for patients with overt radiation-induced neurotoxicity and~     was proven to reduce further development of radiation damage while stimulating idling~     neurons to return to function. Since HBOT is considered safe, we hypothesize that its~     application following radiation, before the manifestation of neurological side effects, may~     help avert development of early/delayed onset radiation-induced neurotoxicity.~      In the proposed study, for the first time, HBOT will be applied early after radiation to~     prevent the expected decrease in patients neurocognitive functions (NCF) and improve their~     quality of life (QOL). The study is designed to provide statistically significant assessment,~     in a prospective randomized clinical trial, of the effect of oxygen stimulation applied soon~     after brain radiotherapy, for patients with primary and secondary brain tumors, on patients~     QOL and NCF. In addition, advanced imaging methodologies will be applied to study the~     feasibility of quantifying oxygen stimulation effects on the tumor and surrounding brain~     tissue.~   "
134361|NCT01808612|"~     The purpose of this study is to evaluate the short-term efficacy and safety of Fluoxetine in~     Japanese adult participants with Major Depressive Disorder (MDD).~   "
134362|NCT01808599|"~     Single arm phase II study of Chlorambucil in combination with subcutaneous Rituximab followed~     by maintenance therapy with subcutaneous Rituximab in patients with histologically proven~     diagnosis of CD20-positive marginal zone B-cell lymphoma of MALT type arisen at any~     extranodal site, either de novo, or relapsed following local therapy (including surgery,~     radiotherapy and antibiotics for H. pylori-positive gastric lymphoma).~   "
134363|NCT01808586|"~     A) Background Chronic neck pain is a significant and common issue which is difficult to~     treat. Tight bands of muscle (trigger points) can be a source of chronic neck pain and they~     are sometimes injected to manage chronic neck pain. However, these injections seldom lead to~     significant, long-lasting relief. In some cases, these trigger points may originate from~     injury or damage to a specific joint in the neck (the facet joint). Treatment of this joint~     with cortisone injection may lead to improved pain relief and function.~      B) Hypothesis By injecting the facet joint with cortisone, the pain associated with tight~     bands of muscle in the neck and shoulders will be relieved to a greater extent than that~     attained through trigger point injection.~      C) Methods Patients with neck pain will have a test to determine if any pain originates from~     the facet joint. Among those who have significant pain from these joints, a comparison~     between the effect of cortisone injection into these joints versus injection into the trigger~     points will be evaluated.~      D) Expected Results and Significance~      It is expected that injection with cortisone into the facet joints will lead to improved pain~     and function when compared to that attained from trigger point injection. In addition, the~     number of trigger points, and the pain and headache that originate from these trigger points,~     are expected to decrease with cortisone injection into the facets to a statistically and~     clinically significant extent. Results from this pilot study will then influence the design~     of future trials into chronic neck pain treatment, leading to better clinical~     recommendations. A peer-reviewed publication and conference presentations will facilitate~     dissemination.~   "
134364|NCT01808573|"~     This is a randomized, multi-center, multinational, open-label, active-controlled, parallel~     design study of the combination of neratinib plus capecitabine versus the combination of~     lapatinib plus capecitabine in HER2+ MBC patients who have received two or more prior HER2~     directed regimens in the metastatic setting.~   "
134368|NCT01808521|"~     In this study, the investigators want to determine if N-acetylcysteine(NAC), given~     intravenously, will decrease complications in patients with Thrombotic Thrombocytopenia~     Purpura (TTP) who are receiving treatment with therapeutic plasma exchange (TPE). The~     investigators want to determine, through anti-oxidant activity, if NAC will have additional~     efficacy in TTP by improving cleavage of the patients' VWF by ADAMTS13, and preventing~     propagation of platelet/VWF strings. This will be manifest by a more rapid improvement in the~     patient's platelet count, decrease in number of days requiring TPE, and decrease in~     microvascular thrombotic complications. The investigators will additionally: 1) Assess safety~     of NAC by evaluating subjects for adverse events and significant adverse events 2) Determine~     effects on TTP by measuring clinical and research laboratory values 3) Determine drug effects~     by measuring clinical and research laboratory values.~   "
134369|NCT01808508|"~     Many individuals with Down syndrome (DS) have breathing problems during sleep. This is called~     obstructive sleep apnea syndrome (OSAS). OSAS is very common in individuals with Down~     syndrome because of the shape of their face and tongue and because of their low muscle tone.~     OSAS can cause a lot of health problems including behavioral and learning problems as well as~     heart problems.~      The purpose of this research study is to look at the effects of treating OSAS in individuals~     with Down syndrome with a machine called Continuous Positive Airway Pressure (CPAP). The~     investigators want to see if treatment of OSAS improves learning, behavior and heart~     problems.~   "
134370|NCT01808495|"~     The purpose of this study is to investigate the role of nuclear Fibulin-1 (FBLN1) in Human~     Corneal Fibroblasts under treatment of mitomycin C (MMC).~   "
134371|NCT01808482|"~     This is a 3-part study where Parts A, B (single-blind - investigator and subject blind) will~     enrol healthy volunteers and Part C (open-label) will enrol RRMS patients. Parts A (single~     ascending dose) and B (repeat ascending dose) will assess safety, tolerability, PK and PD of~     GSK2618960. Part C (repeat doses) will assess safety, tolerability, PK, PD, immunogenicity,~     paraclinical (magnetic resonance imaging [MRI] lesion counts) disease activity and markers of~     Th1 and Th17 mechanisms.~      Part A: Each of the 24 healthy volunteers (divided in 5 groups), will take part in only 2 of~     the planned 8 dosing sessions (A-active, P-placebo). Subjects in each group of Part A will be~     randomized in a 2:1:1 ratio to one of the following sequences: AA, AP or PA such that in each~     dosing session they will receive study treatment in a 3:1 ratio of active: placebo~     respectively.~      Part B: Dosing levels and regimen are dependent upon safety tolerability and PK/receptor~     occupancy (RO) data from Part A. In Cohort 1, 12 subjects will be randomized in a 3:1 ratio~     to A or P. Each subject will receive the same study treatment for repeated doses. If the~     duration of full RO from highest dose in Part A is less than 4 weeks, a second cohort of 12~     subjects in Part B may be recruited, based on Dose Escalation Committee (DEC) decision Part~     C: The 20 RRMS patients will be assigned to active treatments for 2 to 4 repeated doses.~      Safety/tolerability and PK data monitoring and the decision to proceed to the next dose level~     of GSK2618960, and the decisions to proceed to Part B and Part C of the study will be made by~     a dose escalation committee.~   "
134372|NCT01808469|"~     The purpose of this study is to determine the safety, tolerability and distribution and~     elimination of a novel therapeutic drug when administered to Healthy Volunteers. In addition~     its effects on some inflammatory parameters will be measured in presence or absence of~     lipopolysaccharide stimulation.~   "
134373|NCT01808456|"~     Influenza infection in recipients of solid organ transplants recipients while on maintenance~     immunosuppressant therapy is associated with increased morbidity and mortality. Although~     influenza vaccination is recommended in these high-risk patients, safety and immunogenicity~     of commercially available different strengths of influenza vaccine have not been established.~      The primary study objective is to determine the safety and immunogenicity of Fluzone and~     Fluzone High-Dose, with a secondary objective to determine the tolerability and efficacy of~     two different strengths of trivalent influenza vaccine (TIV, flu vaccine). Both vaccines are~     commercially available for use in the general population. Fluzone is approved for use in 6~     months of age and older, and Fluzone High-Dose is approved for use in 65 years of age and~     older.~      This is an exploratory, open-label, parallel group, observer blinded, prospective study. All~     recipients of kidney, lung, heart transplants who attend for post-transplant follow-up, at~     least 30-days after transplantation at Inova Fairfax Hospital Transplant Center will be~     eligible for enrollment.~      Enrolled patients will be followed for three months (a total of 4 visits) following~     enrollment and randomization: day 0 (enrollment) and follow-up visits at weeks 1, 4, 8, and~     12.~   "
134374|NCT01808443|"~     The purpose of this study is to test the efficacy of laser versus cryotherapy on the~     treatment of warts~   "
134375|NCT01808430|"~     This study aims to collect real world outcomes of Video-Assisted Thoracoscopic Surgery (VATS)~     for lung cancer (lobectomy, wedge resection) using ECHELON FLEX™ Powered ENDOPATH® Staplers~     45 mm and/or 60 mm (study devices).~   "
134376|NCT01808417|"~     This research study is a Phase I clinical trial. Phase I clinical trials test the feasibility~     and safety of an investigational technique or drug. This study will try to define an~     appropriate dose of the investigational drug indocyanine green (ICG) in combination with near~     infrared (NIR) imaging to use for further studies. Investigational means that this drug,~     ICG, is approved by the FDA for other imaging uses, but not for lymphatic mapping using NIR~     light. Its use for following lymphatic pathways from tumors in the human body is still being~     studied and research doctors are trying to find out more about it. It also means that the FDA~     has not approved ICG mapping for your type of cancer.~      ICG is a dye and is approved for testing liver function and measuring blood flow from the~     heart. This drug has been used in studies to map lymphatic pathways in lung cancer and breast~     cancer and information from those other research studies suggests that this dye may help to~     identify lymph nodes associated with your esophageal tumor in this research study. ICG can be~     detected within the body using special near-infrared light cameras. In this research study,~     the investigators are looking at how easily ICG can get to the first lymph node (called the~     sentinel lymph node or SLN) associated with your esophageal tumor and whether the~     investigators can see the path of the ICG and the respective SLN using a near infrared~     camera.~   "
135141|NCT01798381|"~     The aim of this project is to investigate the effect of a dietary supplementation with~     essential fatty acids in adults on cognitive functions related to attention and impulse~     control in the general population and in individuals with a diagnosis of attention deficit~     hyperactivity disorder (ADHD).~   "
134377|NCT01808404|"~     College counseling centers (CCCs) are being faced with increasing demands for services to~     meet the treatment needs of their students, in the context of increasingly severe cases and~     declining resources. Innovative, cost effective solutions are needed.~      The proposed project seeks to meet these needs by testing a web-based guided self-help~     version of Acceptance and Commitment Therapy (ACT), an evidence-based transdiagnostic therapy~     found to effectively treat a range of psychological problems. An ACT program would provide a~     means of implementing effective treatment for the range of problems in the CCC setting, while~     the guided self-help format would reduce counselors' workload, improving cost-effectiveness~     and reducing waiting lists. This would both treat students and train counselors in how to~     implement the ACT intervention. Three self-help lessons have been developed, as well as a~     counselor portal to review students' use of the program and to receive training on~     implementing ACT guided self-help.~      The study is a pre-post, open(i.e., non-randomized) feasibility trial with 20 counselors and~     60 clients from multiple CCCs throughout the country.~   "
134378|NCT01808391|"~     This is a prospective, multicenter, historical controlled study. The present clinical study~     will measure non-inferiority of 12 month TLF rate compared to historical control.The selected~     historical control is the Xience V arm from RESOLUTE All-Comer clinical study, that study is~     a prospective, multicenter, randomized, two-arm, international, open-label study.The~     historical control did not have angiographic follow up before 12 months, in the present~     clinical study, only subjects with clinical follow-up conducted at 12 months without any~     pre-specified angiographic assessment prior to 12 month clinical follow-up will be part of~     this analysis cohort. Out of the total 1200 patients, 900 patients (clinical follow-up~     cohort) will be included in this analysis cohort.~   "
134379|NCT01808378|"~     Evaluate the use of the autologous ASC for the treatment of bilateral limbic associated~     keratopathy~   "
134380|NCT01808365|"~     This carriage study aims to evaluate the presence of meningococcus in Asian populations (and~     potential for disease) and explore the extent and serogroup distribution of meningococci~     circulating in the population.~   "
134381|NCT01808352|"~     Black men who have sex with men (MSM) Pre-Exposure Prophylaxis (PrEP) Study with Client~     Centered Care Coordination (C4)Component.~   "
134382|NCT01808339|"~     This study will investigate the effects of altering the time of day of dosing (morning or~     evening) with Fluticasone Furoate 100 (FF 100) micrograms (mcg) once daily administered via a~     dry powder inhaler (DPI) in subjects with persistent bronchial asthma. This is a repeat-dose,~     double-blind, randomized, placebo-controlled, three-way crossover study to compare the effect~     of morning (AM) and evening (PM) dosing with FF 100 on lung function. Twenty-four male and~     female subjects with persistent bronchial asthma will be enrolled to ensure twenty evaluable~     subjects. The three treatments will be FF 100 AM (with placebo PM), FF 100 PM (with placebo~     AM) and matching placebo (AM and PM). All treatments will be administered for 14 (+/-2) days~     with 14 day run-in and 14 to 21 day washout periods. The total duration of the study will be~     approximately 13 to18 weeks for each subject.~   "
134383|NCT01808326|"~     This study is an open-label, single arm, phase II study of chlorambucil in subjects with~     previously untreated CLL.~      The primary objective is to evaluate the response to chlorambucil in Japanese subjects with~     previously untreated CLL.~      Secondary objectives are to evaluate efficacy, safety and pharmacokinetics of chlorambucil in~     Japanese subjects.~   "
134384|NCT01808313|"~     This open label, single-arm, non-controlled, multicentre study will determine the effect of~     ambrisentan on exercise capacity (6MWT) in Chinese subjects with PAH. The study consists of a~     screening period of 4 weeks, a 12-week primary evaluation period (PEP) and a 12-week~     dose-adjustment period (DAP). Ambrisentan 5 mg will be administered to eligible subjects for~     12 weeks (PEP).~   "
134385|NCT01808300|"~     A randomized, open-label, six-sequence, three-period, three-treatment, multiple dosing~     clinical trial to investigate the pharmacokinetic drug interaction between Pregabalin and~     Thioctic acid after oral administration in healthy male volunteers.~   "
134386|NCT01808287|"~     The purpose of this study is to assess the safety and device success of the Edwards SAPIEN 3~     Transcatheter Heart Valve (S3 THV) and the Edwards Commander and Certitude Delivery Systems~     in patients with symptomatic, severe aortic stenosis who are indicated for aortic valve~     replacement.~   "
134387|NCT01808274|"~     The purpose of this study is to assess the safety and device success of the Edwards CENTERA~     Transcatheter Heart Valve (THV) System in patients with symptomatic, severe aortic stenosis~     who are indicated for aortic valve replacement.~   "
134388|NCT01808261|"~     Study MAG104615, a Proof of Concept Study for GSK249320 versus placebo in Stroke Patients.~   "
134389|NCT01808248|"~     This study is to evaluate the safety, tolerability, and antiviral efficacy of sofosbuvir~     (SOF) in combination with peginterferon alfa 2a (PEG) and ribavirin (RBV) administered for 12~     weeks in participants with chronic genotype 2 or 3 hepatitis C virus (HCV) infection who have~     previously failed prior treatment with an interferon-based regimen.~   "
134390|NCT01808235|"~     The purpose of this study is to pilot test an intervention to improve oral health for~     individuals with memory problems. The results from this study will assist in developing~     prevention and intervention programs aimed at maintaining good oral health, or at least~     slowing its deterioration.~   "
134418|NCT01807871|"~     Many smokers who try to stop smoking with nicotine medications (NM) such as gum, lozenge and~     patch, go back to smoking (i.e., a slip or lapse). Currently, labeling on many NM products~     tells smokers who lapse while using NM to stop NM. However, some studies suggest it is safe~     to continue NM upon a lapse and that doing so dramatically increases success at quitting. The~     investigators will test this by doing a randomized trial in which all treatment and measures~     are done from home with paper, phone or computer surveys. The investigators will recruit~     smokers who want to quit, provide them with 10 weeks of nicotine patch treatment and 5 weeks~     of counseling. One group will be asked to stop use of the patch if they lapse and the other~     group will be asked to continue use of the patch if they lapse. The investigators will~     compare the groups on their success at quitting and side-effects.~   "
134500|NCT01806805|"~     Myoclonus Dystonia is a disease in which myoclonus distort the precision of movements and so~     cause a handicap in the movements of the everyday life. Response to oral medications may be~     incomplete and surgery may cause operating risk.~      Zonisamide is an antiepileptic drug which could bring a therapeutic profit in Myoclonus~     Dystonia on the severity of the myoclonus.~   "
134391|NCT01808222|"~     Prostate cancer is the most common solid tumor, with approximately 200,000 new cases~     diagnosed per year. Several different local therapies are available for treatment; including~     surgery and radiotherapy Significant advances have been made which have improved the cancer~     control outcomes and treatment. Despite these significant advances, approximately 30% of~     patients treated with definitive local therapy experience recurrent disease. Recurrent~     (returning) disease usually displays rising PSA (blood test for prostate cancer). The PSA~     level is often of limited use in differentiating local recurrence (i.e. recurrence in the~     prostate bed) from recurrence outside of the prostate bed (extra-prostatic recurrence).~     Imaging plays a central role in the detection of recurrent prostate carcinoma in the prostate~     bed and in the differentiation of prostatic from extraprostatic recurrence. There are newer~     methods of imaging such as magnetic resonance imaging (MRI) and positron emission tomography~     (PET) with molecular radiotracers that are currently under study for the imaging of~     post-therapy recurrence.~      One PET radiotracer which has shown promise in the staging and restaging of patients with~     prostate carcinoma is anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid~     (anti-3-[18F]FACBC) which is a synthetic amino acid analog. FACBC demonstrated higher~     accuracy compared with other methods in the restaging of patients with suspected recurrent~     prostate carcinoma. FACBC has been tested in over 140 subjects in other studies in the Emory~     system including 128 subjects with prostate cancer.~      The investigators will perform a study with 25 patients in whom the investigators have a~     strong suspicion of prostate cancer that has returned to the body after having an initial~     treatment. The major goal of the investigation is to see whether anti-[18F] FACBC PET-CT and~     MRI imaging individually then together will be useful in the detection of local and~     extraprostatic recurrence of prostate cancer. Routine blood test will be done on the day of~     the FACBC scan and one week later as required by the FDA.~      All patients will undergo biopsy of the prostate as clinically appropriate per standard of~     care. If either the FACBC or MRI scans indicate cancer recurrence, the subject's cancer~     site(s) will also be biopsied as clinically appropriate. Biopsy of the suspected recurrence~     sites will be scheduled at the subjects' convenience as soon as possible after the scans.~      Tissue obtained from the biopsy will undergo standard analysis to determine if prostate~     carcinoma cells are present. The secondary goal will be to use left-over biopsy material to~     determine if there are genotypic differences between prostate carcinoma recurrence confined~     to the prostate bed and extraprostatic recurrence~   "
134392|NCT01808209|"~     Clinical Performance of Stenfilcon vs. Filcon II 3~   "
134393|NCT01808196|"~     The purpose of this research study is to test the safety of losartan potassium and see what~     effects (good and bad) it has on you and your eosinophilic esophagitis.~   "
134394|NCT01808183|"~     The purpose of this study is to use a device to compare the blood flow in the patient's~     injured arm to the patient's uninjured arm. This will help us determine 'normal' readings for~     this device for a child's forearm and may in the future help us detect children that have~     injured the blood vessels that go to the forearm when they have an elbow fracture. The~     patient will be one of approximately 100 people involved in this research project at~     Carolinas Medical Center, and the patient's participation will last until the patient is~     discharged from the hospital. It is hypothesized that if the blood vessel is uninjured, the~     readings on the NIRS device on the injured arm will be equal to the uninjured arm. It is also~     hypothesized that if the blood vessel of the injured arm is injured, the readings on the NIRS~     device will be different than on the uninjured arm.~   "
134395|NCT01808170|"~     The purpose of this study is to evaluate the impact of laparoscopic ovarian cystectomy versus~     laparoscopic cyst deroofing on ovarian reserve measured by serum levels of anti mullerian~     hormone and antral follicle count in patients with endometriomas.~   "
134396|NCT01808157|"~     This is a Phase II, multi-centre, randomised, double-blind, placebo-controlled study in male~     and female subjects, aged ≥ 12 years with mild/moderate atopic dermatitis and at least~     moderate pruritus. All subjects will receive BID topical applications of CT327 ointment or~     vehicle for up to 4 weeks.~      At baseline, the subjects must have atopic dermatitis, as defined by the Hanifin and Rajka~     criteria, which involves a minimum of 5% and a maximum of 20% body surface area, an~     Investigator Global Assessment Score of 2 or 3 (mild or moderate) and pruritus visual~     analogue scale scores of ≥ 40mm (at least moderate).~      All subjects will attend a screening visit not more than 21 days prior to Day 1. Subjects~     will be required to return to the clinic on Days 1 (baseline visit), 4, 11, 18 and 29 (end of~     treatment visit). All subjects will be asked to attend for a follow-up visit 14 (±3) days~     after the last dose of study medication.~   "
134397|NCT01808144|"~     This study will assess the serum uric acid lowering effects and safety of lesinurad in~     combination with febuxostat over a long-term timeframe.~   "
134398|NCT01808131|"~     This study will assess the serum uric acid lowering effects and safety of lesinurad in~     combination with allopurinol over a long-term timeframe.~   "
134399|NCT01808118|"~     The objective of this multicenter, randomized, double-blind study was to evaluate the~     efficacy and safety of continuing versus withdrawing therapy with adalimumab 40 mg given~     every other week SC in maintaining remission in subjects with moderate to severe~     non-radiographic axial spondyloarthritis.~   "
134400|NCT01808105|"~     To evaluate growth and tolerance of healthy term infants fed experimental infant formulas, a~     commercial infant formula and human breast milk.~   "
134401|NCT01808092|"~     The purpose of the study is to evaluate the effects of Ceftazidime-Avibactam compared to~     Meropenem for treating hospitalized adults with nosocomial pneumonia including~     ventilator-associated pneumonia~   "
134402|NCT01808079|"~     This clinical trial studies gene analysis in studying susceptibility to Wilms tumor. Finding~     genetic markers for Wilms tumor may help identify patients who are at risk of relapse.~   "
134403|NCT01808066|"~     The purpose of this study is to examine the use of, and reaction to, one particular software~     application(GroundsKeeper) delivered on unique platform - Sifteo cubes (www.sifteo.com). The~     hypothesis is that the use of these devices will increase engagement, motivation, interest,~     and have perceived benefits to users with unique attention-limiting cognitive disabilities.~     How does the observation of and user feedback from gameplay reveal areas of improvement for~     the game, strengths, and perceptions of value among the players and adults?~   "
134404|NCT01808053|"~     To adapt and refine the BodyGuardian remote health monitoring system to acquire ECG, Heart~     rate (HR), activity and breathing data, which will be integrated with weight, blood pressure~     and symptom data, in subjects in an independent living center, with wireless transmission of~     data to a central data analysis hub.~   "
134405|NCT01808040|"~     In this study the investigators want to find out about the effects of this drug in women with~     metastatic breast cancer. The study has two major parts; dose escalation and dose expansion.~     In the first part or dose escalation, subjects will be treated at the lowest dose effective~     in men: 300 mg two times daily. Orteronel (TAK-700) will be increased to reach the highest~     dose tolerated in men: 400 mg two times daily. This part of the study is designed to see if~     female subjects can safely tolerate orteronel (TAK-700), and to measure the changes in~     estrogens and androgens at different levels of TAK-700.~      In the second part of the study (dose expansion), seven women will be treated with the dose~     identified in the first part of the study as being safest and most effective. In this part of~     the study, the investigators want to see if orteronel (TAK-700) will routinely and~     significantly decrease the estrogen levels at the dose which will be used for any future~     studies.~   "
134407|NCT01808014|"~     Posterior lumbar spinal surgical pain leads to a severe degree of pain, and, hence, various~     means of pain management are required. Opioid pain medications such as morphine and fentanyl~     are frequently used as intravenously administered medications. To reduce the use of opioids~     for pain relief, a non-opioid form of pain relief, such as a Non-Steroidal Anti-Inflammatory~     Drug (NSAID), is often added to the regimen.~      With the use of NSAIDs, however, the risk of systemic side effects such as bleeding,~     gastroduodenal bleeding, and kidney damage are being reported, and there is also a report of~     inhibition of spinal fusion; these risks limit the use of NSAIDs.~      Nefopam, a new centrally-acting analgesic agent, has been reported in an animal study to~     desensitize post-surgical pain, and when used with an opioid analgesic, it indirectly~     controlled the NMDA receptor, which inhibited the generation of c-fos gene at the spine.~     There are also reports that Nefopam managed pain by inhibiting the serotonin reuptake~     receptors.~      In clinical practice, the administration of Nefopam in patients who required post-surgical~     pain management reduced the use of opioid analgesics by 20-50 % and also reduced the~     prevalence of nausea and vomiting.~      Therefore, the investigators considered whether the addition of Nefopam for intravenous~     patient-controlled analgesia in patients with lumbar spinal surgery would reduce the side~     effects seen in monotherapy with opioid analgesia and result in effective pain management.~     This study was conducted to address this question.~   "
134408|NCT01808001|"~     This study will determine if operating room teams manage a simulated event more effectively~     using a critical event checklist. Performance will be evaluated using a score based on how~     closely they follow a protocol for critical event management; a 'team' score and a score~     based on clinical recovery of the simulated patient. All teams will receive a debriefing~     session after managing 4 scenarios. Teams will return and manage 4 further scenarios after a~     period of 6-9 months.~      The investigators will be testing the hypothesis that both clinical and behavioral team~     performance will improve with the use of Critical Event Checklists. The investigators also~     expect that health professional (participant) could attain knowledge related to the~     importance of non-technical skills and the use of CECs in the management of critical events.~   "
134409|NCT01807988|"~     The main purpose of the study is to test whether Internet-based relapse prevention plus~     medication has a better protective effect compared to medication only, for persons with~     residual depressive symptoms who are currently in paid employment or in education. We~     hypothesise that during the two years following the intervention:~        -  The persons in the group receiving Internet-based relapse prevention plus medication~          will be absent from work for fewer days due to sick-leave compared to those in the~          medication-only group.~        -  Fewer persons in the group receiving Internet-based relapse prevention + medication will~          experience long term sick-leave (60 days or more) compared to those in the~          medication-only group.~        -  The persons in the group receiving Internet-based relapse prevention plus medication~          will suffer fewer depressive relapses compared to those in the medication-only group.~        -  At follow-up, the persons in the group receiving Internet-based relapse prevention plus~          medication will have higher health related quality of life and lower levels of~          depressive symptoms compared to those in the medication-only group.~   "
134410|NCT01807975|"~     A study to evaluate the role of forced oscillation in precocious diagnosis of bronchiolitis~     obliterans syndrome in patients with pulmonary transplant (time difference in detecting~     distal airways functional impairment by forced oscillation and the standard technique using~     spirometry).~   "
134411|NCT01807962|"~     We hypothesize that local ultrasound guided injection with corticosteroid and local~     anaesthetic are effective on the symptoms of GTPS.~   "
134412|NCT01807949|"~     The primary objective of the study was to evaluate the efficacy of lumacaftor in combination~     with ivacaftor at Week 24 in participants aged 12 years and older with cystic fibrosis (CF)~     who are homozygous for the F508del mutation on the CF transmembrane conductance regulator~     (CFTR) gene.~   "
134413|NCT01807936|"~     Esophageal carcinoma is an aggressive disease with a poor prognosis. Surgical resection with~     radical lymphadenectomy remains the basic method of management of this malignancy. Lymph node~     metastasis is one of the most important factors in predicting the prognosis of patients with~     esophageal carcinoma, but the extent of lymph node dissection is still in debate, and there~     is no statistical evidence based on large scale prospective randomized trials with regard to~     the issue that which is the optimal extent of lymphadenectomy for esophageal cancer. The~     purpose of this study is to test two different extents of lymphadenectomy~     (Cervical-thoracic-upper abdominal three-field lymphadenectomy and Thoracic-upper abdominal~     two -field lymphadenectomy) in middle or lower third intrathoracic esophageal cancer. This~     research is being done to see whether one extent of lymphadenectomy is superior than the~     other with better long-term outcome and acceptable postoperative short-term outcome or not.~   "
134414|NCT01807923|"~     The primary objective of the study was to evaluate the efficacy of lumacaftor in combination~     with ivacaftor at Week 24 in participants aged 12 years and older with cystic fibrosis (CF)~     who are homozygous for the F508del mutation on the CF transmembrane conductance regulator~     (CFTR) gene.~   "
134415|NCT01807910|"~     The investigators overall hypothesis is that exacerbation of endoplasmic reticulum (ER)~     stress in the liver is associated with significant alterations in phosphatidylcholines that~     drive the NASH phenotype in obese humans. The investigators plan to examine this hypothesis~     in a well-characterized cohort of obese subjects that are scheduled for bariatric surgery.~     Methyl-D9-choline chloride will be infused before and after a 2-week high fructose or glucose~     feeding to determine the biosynthesis and kinetics of secretory lipoprotein phospholipids. It~     is proposed that phospholipid metabolism play an important role in the pathogenesis or~     etiology of fatty liver in non-alcoholic conditions through mechanisms that invoke ER and~     oxidative stress responses.~   "
134416|NCT01807897|"~     The purpose of this study is to compare three treatment modalities for central, or mixed~     obstructive and central, sleep apnea in patients with chronic heart failure and reduced~     ejection fraction. The modalities to be tested are nocturnal supplemental oxygen (NSO) and~     continuous positive airway pressure (CPAP). The main outcome measures will be left~     ventricular ejection fraction on echocardiogram and peak oxygen consumption on~     cardiopulmonary exercise testing.~   "
134417|NCT01807884|"~     The purpose of this study is to evaluate the impact of an optimized suctioning procedure on~     the risk of endotracheal microaspiration, measured by tracheal to oropharyngeal ratio of~     amylase enzymatic activity.~   "
134419|NCT01807858|"~     Study, the inclusion of very low birth weight premature infants followed in Dr.Sami Ulus~     Maternity and Children Training and Research Hospital, Department of Neonatology; be~     randomized to very low birth weight premature infants began eating until you are discharged~     from the hospital once a day to feed a group+ 900 mg of 5 billion active Bifidobacterium~     lactis, the addition of chicory inulin, in the other group given placebo; Patients taking~     weekly blood cultures, the presence of residues in both groups during feeding, to evaluate~     the incidence of NEC and sepsis are planned. Randomization and the number of patients planned~     to separate into groups.~   "
134420|NCT01807845|"~     Background: Vitamin D3 (VD) is an oil soluble vitamin formed in the skin during exposure to~     UV light. It is essential for bone and calcium metabolism, insulin reactivity, immune system~     etc. The dietary sources of VD are scarce, and insufficient. Epidemiological studies link~     proper VD status with lower risks of bone fracture, hypertension, diabetes, cancer and more.~     VD deficiency is widespread, mainly due to avoidance of sun exposure due to fear of melanoma.~     Therefore there is an urgent need to enrich staple foods & beverages with VD, to prevent~     deficiency.~      A novel technology was developed , for nanoencapsulating VD within casein micelles (CM)~     (natural milk protein nanoparticles). Previously we have found that the bioavailability of VD~     in CM in 1% fat milk was similar to that in an aqueous dietary supplement based on a~     synthetic emulsifier- Tween 80- which is sometimes used by the industry to add VD into milk.~      The main research question studied in the current project is: how will the bioavailability of~     VD be affected by its delivery in CM compared to its delivery using Tween 80 in a fat free~     milk product, like nonfat yogurt.~      Hypothesis: The open molecular structure of caseins, which evolved to be easily digestible,~     may facilitate the bioavailability of VD nanoencapsulated in CM, so that it will not be less~     than that in Tween 80, which is considered to be good. CM are particularly useful for~     oil-soluble micronutrient delivery in non-fat products. The most widely consumed nonfat milk~     product is 0% fat yoghurt, chosen it for this study.~      Methods: Yoghurts will be made from 3 milk formulations:~        1. Skim milk (0% fat) enriched with 50,000 international units (IU) VD in 150 gr product,~          in CM.~        2. Skim milk with same dosage of VD, emulsified with Tween 80.~        3. Placebo: skim milk without added VD. 90 healthy adults, aged 18-65, having passed a~          medical qualification examination, will be randomly assigned to 3 groups. Following~          over-night fasting they will each consume a 150 gr yoghurt sample as detailed above, and~          be requested to fast 2 more hours. Blood will be sampled before yoghurt consumption, and~          after 1, 7 and 14 days following consumption. Blood-serum level of 25(OH)D (the form of~          VD used as a status indicator in routine blood tests), by chemiluminescence immunoassay~          (CMIA).~      Expected findings: The bioavailability of VD in CM will not be lower than that in Tween 80,~     in 0% fat yoghurt.~      Significance of the study: With the widespread VD deficiency, decreased fat consumption and~     rising demand for using only natural ingredients there is great importance in delivery of VD~     and other fat-soluble micronutrients in protein-based delivery systems, like CM, instead of~     using synthetic emulsifiers, and it is imperative to assure the bioavailability is not~     compromised by this dramatic change.~      CM solubilize VD and help uniformly distribute it in aqueous products and protect it against~     heat, oxidation and UV.~   "
134421|NCT01807832|"~     The purpose of this study is to determine whether the capsaicin challenge can improve the~     diagnosis, treatment, monitoring and follow-up in patients with chronic cough.~   "
134422|NCT01807819|"~     The purpose of this study is to determine if analysis of heart ultrasound images with new~     software programs will provide better understanding as to the specific heart problems that~     lead to symptoms of heart failure.~   "
134423|NCT01807806|"~     This project is a partnership between Soar Technology, the University of Southern California~     (USC) Center for Innovation and Research on Veterans and Military Families (CIR) and the USC~     Creative Media and Behavioral Health Center (CM&BHC) to conduct a Safety and Effectiveness~     Study (SES) for an educational role-playing game developed by Soar Technology, Inc. The~     purpose of the intervention to be delivered by Soar Technology is to educate families and~     friends with the ultimate goal of empowering them to have a conversation with the~     veteran/service member about readjustment issues. The study will assess the safety and~     effectiveness of the provided game using personal interviews, play testing, and surveys. The~     game playing experience is hypothesized to be safe and effective with respect to having~     conversations with veterans/service members following deployment.~   "
134424|NCT01807793|"~     Stroke is the leading cause of disability, third leading cause of death, and one of the most~     resource-intensive diseases among Americans. African-Americans (AA) have a stroke rate nearly~     double that of Euro-Americans (EA), and AA who experience a first-ever stroke are younger,~     have greater stroke disability, more post-stroke complications, and slower recovery compared~     to EA.~   "
134425|NCT01807780|"~     The purpose of this study is to determine if multiple vaccination in military personnel may~     be correlated with the appearance of poorly defined diseases as symptomatic multisyndrome,~     autoimmune or lymphoproliferative disorders. At the same time, considering possible~     interference between different vaccines, proteins and polysaccharides, living and~     inactivated, the study aims to assess the immunogenicity and efficacy also in relation to the~     specific Human Leucocyte Antigens (HLA) genetic structure.~   "
134426|NCT01807767|"~     The objective of the study is to determine the efficacy and safety of Everolimus conversion~     in liver transplantation. Most large US liver centers transplant patients with high Model for~     End-Stage Liver Disease (MELD) scores. However, many of the sponsored liver transplant trials~     in the US do not include patients with high MELD scores making it difficult to extrapolate~     these trial data to the patients cared for at larger liver transplant centers. The greatest~     potential benefit of mammalian target of rapamycin (mTOR) inhibitors is the avoidance of the~     side-effects of calcineurin-inhibitors, namely, renal insufficiency, diabetes and~     hypertension. Therefore, this protocol is designed to study the efficacy and safety of~     everolimus and Myfortic in liver transplant patients with high MELD scores at two large~     centers with a vast experience in the administration of mTOR inhibitors.~   "
134427|NCT01807754|"~     This is a pilot, simulated breast cancer screening study. The goal of the study is to explore~     these scanning modalities:~      1) Combined digital breast tomosynthesis(DBT)/dual-sides 3 dimensional-automated~     ultrasound(AUS)~      2. Explore the utility of photoacoustic imaging as an adjunct to digital breast~     tomosynthesis(DBT)/ultrasound(US)alone.~   "
134428|NCT01807741|"~     The purpose of this study is to compare asenapine with placebo in the treatment of depression~     associated with bipolar disorder, type I over eight weeks.~      We hypothesize that patients will show significantly greater improvement with asenapine than~     placebo over eight weeks of treatment.~   "
134429|NCT01807728|"~     The objective of this study is to determine the effectiveness of different training programs~     on outcomes in persons with spinal cord injury (SCI). We are interested to see which programs~     have the greatest impact.~   "
134430|NCT01807715|"~     The investigators will conduct a voluntary anonymous survey at four separate Sacramento area~     family planning clinics. The investigators will ask the staff at each facility to offer a~     survey to all women 18 and older presenting to the clinic to have a first trimester (<12~     weeks gestation) surgical abortion. Gestational age will be based on what the woman believes~     is her gestational age at presentation, before any evaluation in the clinic. Women who cannot~     understand or read the survey will be excluded. The investigators hope to implement the~     survey at these clinics for 3-4 months reaching a minimum of 200 women (based on a target~     population of 600 women receiving surgical first trimester abortions at these two clinics~     over a 3-4 month period with a 95% confidence interval).~   "
134431|NCT01807702|"~     The purpose of the test is to measure an enzyme called pyruvate. Subjects will fast for 12~     hours and then undergo a breath test, have blood drawn, and cells from the inside of the~     mouth collected over a 12 hour period. The tests will be repeated at least a week later and~     subjects receive a dose of dichloroacetate (DCA)~   "
134432|NCT01807689|"~     This is a multi-center clinical study to compare the performance of a collective panel of~     salivary biomarkers to discriminate SS from non-SS in sicca cohorts recruited from three~     clinical sites with the diagnostic outcomes based on the new classification criteria for~     Sjögren's syndrome by the American College of Rheumatology (ACR) developed in 2012. This is~     not a treatment study, but a pilot study to confirm diagnostic ability of a panel of salivary~     biomarkers. All enrolled subjects must be classified as having both oral and ocular sicca~     symptoms without another autoimmune/connective tissue disease (Appendix 2). At the University~     of California in Los Angeles, using molecular techniques, we will quantify discriminatory~     biomarkers in saliva collected from enrolled subjects, who are also being evaluated as part~     of their clinical care using the standard diagnostic tests of the 2002 AECG criteria. We also~     will test the performance of these biomarkers to predict the diagnosis of pSS according to~     the AECG criteria, as these are the most widely used tests to diagnose pSS and assess disease~     activity worldwide.~   "
134434|NCT01807663|"~     Determing optimal time of ventilator disconnection is a challenge for both acute and chronic~     neuromuscular disease. In one case it is helpful for weanning from ventilator and in the~     other to optimize daytime ventilation in the most severe patients. The investigators propose~     to validate a new non invasive tool for monitoring respiratroy parameters in neuromuscular~     patients in both acute and chronic conditions.~   "
134435|NCT01807650|"~     The main purpose of this phase III clinical trial is to show safety and efficacy of~     Oleogel-S10 in the acceleration of Split-Thickness Skin Graft Donor Sites.~   "
134436|NCT01807637|"~     The purpose of this study is to determine if transcranial direct current stimulation~     (tDCS)applied over the lower extremity motor cortex in conjunction with functional electrical~     stimulation assisted gait training (FESAGT) is effective for improving gait in patients with~     chronic stroke.~   "
134437|NCT01807624|"~     The purpose of this study is to determine the pharmacokinetics/pharmacodynamics and safety of~     a nasal spray containing the anesthetic drug tetracaine in combination with oxymetazoline~     with blood draws over 24 hours.~   "
134438|NCT01807611|"~     In this study, participants with high-risk hematologic malignancies undergoing hematopoietic~     cell transplantation (HCT), who do not have a suitable human leukocyte antigen (HLA) matched~     related/sibling donor (MSD) or matched unrelated donor (MUD) identified, will receive a~     haploidentical donor HCT with additional natural killer (NK) cells.~      The investigators anticipate enrollment of 75 donors and 75 recipients.~      PRIMARY OBJECTIVE:~        -  To estimate the rate of successful engraftment at day +42 post-transplant in patients~          who receive haploidentical donor stem cell plus NK cell transplantation with TLI based~          conditioning regimen for high risk hematologic malignancy.~      SECONDARY OBJECTIVES:~        -  Estimate the incidence of malignant relapse, event-free survival, and overall survival~          at one-year post-transplantation.~        -  Estimate incidence and severity of acute and chronic (GVHD).~        -  Estimate the rate of transplant related mortality (TRM) in the first 100 days after~          transplantation.~   "
134439|NCT01807598|"~     This pilot clinical trial studies brentuximab vedotin in treating patients with advanced~     systemic mastocytosis or mast cell leukemia. Monoclonal antibodies, such as brentuximab~     vedotin, can block cancer growth in different ways. Some block the ability of cancer cells to~     grow and spread. Others find cancer cells and help kill them or carry cancer-killing~     substances to them~   "
134440|NCT01807585|"~     This is a randomized control trial comparing VenaSeal Sapheon Closure System with~     Radiofrequency Ablation.~   "
134441|NCT01807572|"~     Obesity is associated with increased risk for mortality, atherosclerotic cerebrovascular~     disease, coronary heart disease, colorectal cancer, hyperlipidemia, hypertension, gallbladder~     disease, and diabetes mellitus, resulting in over 111,000 deaths annually in the United~     States ). In the US, 65% of adults are overweight or obese. Unfortunately, the treatment of~     choice for obesity (behavioral weight loss treatment) only results in a 10% reduction in body~     weight on average and most patients regain this weight within a few years. Further, most~     obesity prevention programs do not reduce risk for future weight gain. The limited success of~     treatment and prevention interventions may be due to an incomplete understanding of the~     processes that increase risk for obesity. Recent data suggest that obese adults show~     abnormalities in reward from food intake and anticipated food intake relative to lean adults,~     but the precise nature of these abnormalities is unclear and it has not been established~     whether these abnormalities predate obesity onset or are a consequence. It is vital to~     elucidate risk factors for obesity onset to advance understanding of etiological processes~     and determine the content of prevention and treatment programs.~      The goals of this study are to (1) determine whether adolescents at high-risk for obesity, by~     virtue of having two obese parents, show abnormalities in reward from food intake~     (consummatory food reward) and anticipated reward from food intake (anticipatory food reward)~     compared to adolescents who are at low-risk for obesity, (2) determine whether abnormalities~     in consummatory and anticipatory food reward increase risk for weight gain and obesity onset,~     (3) examine moderators that may amplify the relations of consummatory and anticipatory food~     reward to unhealthy weight gain, and (4) examine changes in consummatory and anticipatory~     food reward in those participants who show obesity onset relative to those not showing~     obesity onset. Each of these goals is described in more detail below.~   "
134442|NCT01807559|"~     The objective of this multi-site observational study is to further assess the long-term~     patient use of the Sonitus SoundBite Hearing System. Information can be gained by assessing~     benefit for the subjects that were enrolled in the SoundBite Hearing System Long Term Multi~     Site Study (Protocol CLN006) for an additional 12 months.~   "
134443|NCT01807546|"~     The primary objective of this study is to determine if tumors in patients with papillomavirus~     (HPV) positive or negative squamous cell carcinoma (SCC) that no longer responds to standard~     therapy will decrease in size following treatment with the investigational drug, rigosertib~     sodium (ON 01910.Na). A secondary objective is to determine if treatment with rigosertib~     causes any side effects.~      Rigosertib is an investigational drug, which means that it has not been approved by the U.S.~     Food and Drug Administration (FDA) to treat any diseases. We are studying rigosertib as a new~     anticancer drug. Tests that we have done in the laboratory suggest that rigosertib works by~     blocking cell division in cancer cells and causing them to die.~   "
134444|NCT01807533|"~     Four hypotheses will be tested in this study:~        1. The intervention group performs better in child, parent and transactions outcomes than~          the control group throughout the follow-up period.~        2. The intervention group shows greater changes in early neurophysiological brain functions~          and transactions within the family that lead to better neurodevelopmental outcomes than~          the control group.~        3. Certain polymorphisms of the dopamine-related genes are associated with the~          neurodevelopmental outcomes in VLBW preterm infants.~        4. Very low birth weight preterm infants carrying more genetic plasticity in the~          dopamine-related genes may benefit more from the interventions than those carrying less~          genetic plasticity.~   "
134445|NCT01807520|"~     This purpose of this study was to demonstrate the efficacy of secukinumab versus placebo on~     nail psoriasis and to assess long-term efficacy, safety and tolerability of secukinumab.~   "
134446|NCT01807507|"~     Measure accuracy of vein width using VeinViewer®, compared against ultrasound imaging as a~     gold standard~   "
134460|NCT01807325|"~     The nature of cysts and solid masses in the pancreas can be difficult to diagnose. They may~     be benign, precancerous, or cancer. Current tests such as cytology (looking under a~     microscope) and tumor markers do not always give us the answer. The investigators are looking~     for genetic markers on biopsy specimens from the pancreas that will give us a better test for~     diagnosis. This study is only for diagnosing these lesions. The investigators are not~     treating any patients.~   "
134501|NCT01806792|"~     The purpose of this study is to evaluate the efficacy and the safety of Risedronate,~     cholecalciferol combination tablet in patients with Osteoporosis~   "
135142|NCT01798368|"~     The purpose of this study is to demonstrate that the treatment does not cause any clinically~     significant effects that would put patients at risk.~   "
134447|NCT01807494|"~     Hip replacement is a common surgical procedure performed to relieve the pain and disability.~     In general, the surgery consists of replacing the diseased or damaged joint surfaces of the~     hip with metal and plastic components shaped to allow continued motion of the hip. Surgeons~     may perform this operation in several different ways. The purpose of this study is to compare~     two different methods of performing total hip replacement. The investigators hypothesize that~     subjects treated with the anterior approached may show improved function during the early~     postoperative period, but that no differences in pain or function will be present after the~     first postoperative year.~      In this study, patients that have elected to have hip replacement and consented to~     participate in the study will be randomized to have his or her hip replaced using one of two~     surgical techniques. Subjects will be randomized to be implanted using either an anterior or~     posterior approach. With the anterior approach, the study surgeon will use an incision that~     is on the front of the hip, and with the posterior approach, the incision will be more on the~     backside of your hip. The study surgeon has done more than 300 total hip replacements with~     both of these techniques.~      A baseline assessment will be conducted before hip replacement surgery that includes x-rays,~     functional tasks like getting up from a chair and stepping down a step, and three~     questionnaires about the hip, the subject's general health, and how well the subject is able~     to function. Also, subjects will be required to return to the clinic at several time points~     after surgery for follow-up visits. Follow-up visits will include hip assessments and~     questionnaires, as well as follow-up hip x-rays. The follow-up visits will be 6 weeks, 3~     months, 1 year, 2 years, 5 years, 7 years, and 10 years after hip replacement surgery. These~     follow-up visits are part of the study surgeon's normal routine for hip replacement patients,~     and are not extra visits as a part of this study.~   "
134448|NCT01807481|"~     The primary objective of study is to evaluate the no of patients which maintain the Hb level~     between 9.0 ~ 12.0 g/dl during the evaluation period~   "
134449|NCT01807468|"~     To evaluate feasibility and efficacy of haploidentical stem cell transplantation in patients~     with high-risk solid tumors who failed after tandem high-dose chemotherapy and autologous~     stem cell transplantation.~      To evaluate feasibility and efficacy of NK cell infusion after haploidentical stem cell~     transplantation in patients with high-risk solid tumors who failed after tandem high-dose~     chemotherapy and autologous stem cell transplantation.~   "
134450|NCT01807455|"~     The purpose of this study is to demonstrate the efficacy and safety of Restylane Vital~     Lidocaine when acne scars are treated~   "
134451|NCT01807442|"~     The purpose of the study is to understand peoples' positive emotions, like how optimistic or~     grateful they feel, after they have had a heart problem. The investigators want to determine~     whether positive emotions affect peoples' ability to follow recommendations, like following a~     healthy diet, exercising, and taking medication.~   "
134452|NCT01807429|"~     the investigators assessed the effects of low-dose IV ketamine-midazolam versus morphine on~     pain control in trauma patients with closed limb fracture(s); and also compared the incidence~     of adverse events (mainly cardio pulmonary ) between two groups.~   "
134453|NCT01807416|"~     Aim of the present study will be to evaluate if the platform switching and the flat abutment~     can modify the peri-implant marginal bone remodelling. A clinical assessment of the soft~     tissues will also be provided.~      80 consecutively inserted dental implants will be included in this study. Maxillary and~     mandibular implants will be considered, both in frontal and posterior area. After 6 to 12~     weeks, the definitive prosthetic abutment will be screwed and the temporary crown cemented.~     After 2 more months, the definitive porcelain crown will be delivered. The final outcomes~     will be collected after 1 year from implant insertion.~      Data will refer to the following timing:~      T0= implant installation T1= temporary crown cementation T2= definitive crown cementation T3=~     1 year follow-up The 80 implants will be randomly divided into 4 groups of 20 implants each,~     with different implant/abutment design.~      Group 1: Tapered T3 Standard Collar implants + GingiHue abutments Group 2: Tapered T3~     Standard Collar implants + Tissuemax IL abutments Group 3: Tapered T3 Prevail implants +~     GingiHue abutments Group 4: Tapered T3 Prevail implants + Tissuemax IL abutments On x-rays,~     the mesial and distal Marginal Bone Level will be measured and compared among and between the~     groups at the 4 different timing.~      Pocket Depth and Bleeding on probing (mesial, buccal, distal and lingual) will be measured at~     T0, T1, T2 and T3. Data will be statistically analyzed.~   "
134454|NCT01807403|"~     Deep brain stimulation (DBS) has been proposed for severe and resistant obsessive-compulsive~     disorder. This electrical stimulation has been tested on, and shown to be effective at,~     different targets (subthalamic nucleus, caudate nucleus & nucleus accumbens). However, the~     efficacies of each target have never been compared directly.~      This protocol aims to do so, with the hypothesis that subthalamic (STN) stimulation will be~     more efficacious.~   "
134455|NCT01807390|"~     This study will examine the perspectives of patients' undergoing surgery for lung or~     esophageal cancer. It will examine both pre-op and post-op patient perspectives and opinions~     regarding pain and surgical complications. This study will also assess a general health~     related quality of life pre-op and post-op. Additionally, it will examine the importance of~     receiving care close to home and their support system.~      Hypotheses:~        1. The data will allow investigators to better understand the willingness of patients to~          participate in prospective, randomized studies comparing minimally invasive and open~          thoracic surgery. Patients will not be willing to undergo randomization to an open~          versus minimally invasive surgical procedure.~        2. The pain associated with Minimally Invasive Surgery (MIS) will be perceived and~          documented as lesser than open surgery.~        3. Patients may be willing to accept a higher risk of complications or more post-operative~          pain if they were given the option to be cared for closer to their home.~   "
134456|NCT01807377|"~     This study is designed to assess the safety, tolerability and pharmacokinetics of multiple~     oral 200-mg doses of PF-05175157 administered twice daily for 14 days in healthy overweight~     and obese subjects.~   "
134457|NCT01807364|"~     Treatment with glucocorticoids and mineralocorticoids has changed congenital adrenal~     hyperplasia (CAH) from a fatal to a chronic lifelong disease. Long-term treatment, in~     particular the chronic (over-)treatment with glucocorticoids, may have an adverse effect on~     the cardiovascular risk profile in adult CAH patients. The objective of this study was to~     evaluate the cardiovascular risk profile of adult CAH patients.~   "
134458|NCT01807351|"~     Retrospective cohort of all the patients with elevated blood sugar (but no Diabetes)~     attending the study sites from 2002 to 2007. We retrieval their records to see how many of~     them actually developed diabetes. The patient's record will be followed up to 6 years after~     their first abnormally high blood sugar checked. We will measure their parameters including~     sex, age, pay code and whether they have hypertension or not to see what factors will~     increase risk of DM development.~   "
134459|NCT01807338|"~     The purpose of this study is to document the long-term safety and tolerability after~     intracerebroventricular (ICV) administration of sNN0031 (PDGF-BB) in patients who~     participated in study sNN0031-001~   "
135161|NCT01798121|"~     A study to determine bioequivalence of PPD material versus Reference Standard.~   "
134461|NCT01807312|"~     It has been reported that carbon dioxide (CO2) insufflation can reduce patient pain and~     abdominal discomfort during and after colonoscopy. Its safety and efficacy during colonoscopy~     even under sedation has been already assessed in some earlier trials. Air insufflation is~     still the standard method, however, due a lack of suitable replacement of equipment or~     technical improvement in colonoscopy.~      The investigators use radio frequency identification (RFID) technology to record the number~     of times and duration in the toilet of the patient after colonoscopy examination. These data~     may be proxies for discomfort. With application of CO2 insufflation, the times and duration~     in the toilet after examination will decrease as well as patient's discomfort after~     procedure, and further improvement of patient compliance can be anticipated.~   "
134462|NCT01807299|"~     The attention deficit hyperactivity disorder (ADHD) usually occurs in preschool and may cause~     disabilities through whole life. The treatment of this disease is expensive and difficult.~     Moreover, physical exercise and omegas consumption may improve the cognitive functions and~     behavior, so it could be an interesting strategy to improve this disorder. The aim of the~     present study is to verify the effects of multiple components physical training and the~     consumption of omega 3 on behavior, cognitive functions and the serum levels of BDNF and~     IGF-1 in ADHD children. Thus, 68 ADHD children, between seven and fourteen years old will be~     selected. The volunteers will be randomly divided into four groups: Physical Training Group~     (PTG), Omega Group (OG), Omega and Physical Training Group (OPTG) and Control Group (CG). The~     protocol of the experiment will last three months in which the OPTG will make physical~     training and receive fish oil capsules, and the PTG will make only the physical training and~     receive a placebo of fish oil. The others groups will be oriented not to make any type of~     physical training, but the OG will receive fish oil capsule, and the CG will receive a~     placebo of fish oil. Behavioral and cognitive functions evaluations and blood analysis will~     be made at the beginning and at the end of the protocol.~   "
134463|NCT01807286|"~     The goal of this clinical research study is to find the highest tolerable dose of~     pomalidomide that can be given in combination with melphalan and dexamethasone that can be~     given to patients with AL amyloidosis. The safety of this drug combination will also be~     studied.~      Pomalidomide is designed to change the body's immune system. It may also interfere with the~     development of tiny blood vessels that help support tumor growth. This may decrease the~     growth of cancer cells.~      Melphalan is designed to damage the DNA (genetic material) of cells, which may cause cancer~     cells to die.~      Dexamethasone is a corticosteroid that is similar to a natural hormone made by your body.~     Dexamethasone is often given to Multiple Myeloma (MM) patients in combination with other~     chemotherapy to treat cancer.~      Planned Phase I/II Study terminated early during Phase I portion without continuation to~     Phase II.~   "
134464|NCT01807273|"~     Investing the Timed Up and Go (TUG) Test in Hemiplegic Patients Using 3D Motion Analysis~   "
134465|NCT01807260|"~     To evaluate and compare the results of conventional and stepwise shock wave lithotripsy~     treatment modalities in pediatric urinary lithiasis.~   "
134466|NCT01807247|"~     The aim of the study is to evaluate the short effects of a two rehabilitation session~     commonly performed in physical therapy,~        1. muscle strengthening of the lower limbs and~        2. effort reconditioning with cyclo ergometer, on gait characteristics (kinematics,~          kinetics and electromyographic) in patients with central nervous system lesion.~   "
134467|NCT01807234|"~     The investigators propose to test the efficacy of ketorolac nasal spray versus sumatriptan~     nasal spray versus placebo for acute abortive therapy of migraine head pain as well as for~     migraine associated symptoms including nausea and allodynia.~   "
134468|NCT01807221|"~     To assess a new drug, BAY94-8862, given orally at different doses, to evaluate whether it is~     safe and can help the well-being of patients with worsening chronic heart failure and either~     type II diabetes with or without chronic kidney disease or kidney disease alone. These~     treatment doses will be compared to eplerenone, another marketed drug approved to treat heart~     failure.~   "
134469|NCT01807208|"~     The goals of this study are two fold: 1) To learn whether a personalized patient health goal~     and reminder tool helps patients to learn more about their condition and to make changes in~     behavior and medication taking to reduce the risk of another heart attack. 2) To examine a~     blood sample to learn how patients are responding to their medications. The study team will~     enroll approximately 220 patients in the hospital recovering from a heart attack. Half of the~     patients will receive the educational tools and a copy will be sent to their outpatient~     provider.~   "
134470|NCT01807195|"~     Generally, a contrast medium is used when performing a CT scan or radiographic tests such as~     angiography because it heightens image clarity and can increase diagnosis accuracy. Despite~     these advantages, contrast media can cause allergic reactions in the body or a decline in~     renal function. Therefore, they should be handled carefully and explained sufficiently to the~     patient. For intensive care patients, the use of contrast agents has been revealed as a major~     cause of acute renal damage, and many studies have investigated this complication by~     examining incidence rates and prevention strategies. Hypothesis: Among intensive care~     patients, the group in which a contrast medium was used will have a higher risk of renal~     function decline compared with the group in which a contrast medium was not used, and, hence,~     the use of contrast media becomes a cause of renal function deterioration. Categorizing~     patients with renal function decline according to the new RIFLE criteria can have an~     association with the prognosis of intensive care patients, such as hospitalization period and~     death rate, which can promote faster intervention.~   "
134471|NCT01807182|"~     This phase II trial studies how well tumor-infiltrating lymphocytes (TIL) after combination~     chemotherapy works in treating patients with melanoma that has spread to other places in the~     body. Biological therapies, such as TIL, may stimulate the immune system in different ways~     and stop tumor cells from growing. Drugs used in chemotherapy, such as cyclophosphamide and~     fludarabine phosphate, work in different ways to stop the growth of tumor cells, either by~     killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving~     TIL after combination chemotherapy may kill more tumor cells.~   "
134498|NCT01806831|"~     The laser areas treated with biocellulose sheet from coconut juice containing~     anti-hyperpigmentation agent (biocellulose mask, Farhorm®) heal faster than vaseline~     ointment which is a standard treatment.~   "
134472|NCT01807169|"~     The endoscopic management of patients on anti platelet agents (APA) is a wide problem, with~     prevalence of patients on this type of therapy steadily increasing. The benefit / risk~     balance to stop or continue the APA for the digestive endoscopic procedure confronts us every~     day in clinical practice to another: the relationship thrombosis / hemorrhage.~      Molecules most commonly used today are aspirin and clopidogrel. Current recommendations from~     the European Society of Gastrointestinal Endoscopy (ESGE) allow the maintenance of aspirin~     for the polypectomy. Some preliminary data show that the risk of bleeding during endoscopic~     mucosal resection (EMR) with aspirin is not significantly higher than polypectomy. The~     concept of polypectomy / EMR without stopping aspirin is progressively accepted and returned~     gradually to the usual practice. However, these procedures are still not allowed under~     clopidogrel, or in a dual APA therapy, in the absence of relevant data on the subject in the~     literature.~      It is necessary to achieve a large national multicenter study, to clarify the risk of post~     recto colonic EMR and polypectomy bleeding in patients under clopidogrel alone or in~     combination (aspirin and clopidogrel) taking into account the endoscopic preventive measures~     used in daily practice by endoscopists in expert centers (clip, ligature and loop devices,~     preventive adrenalin injection).~      The aim of the MEDOC study is to determine the incidence of immediate and delayed bleeding~     after colonic polypectomy and / or EMR for patients on clopidogrel.~      It is expected in this work an incidence of post-polypectomy bleeding close to that observed~     during the implementation of these actions in the population without any anti platelet~     agents.~   "
134473|NCT01807156|"~     The purpose of this study is to learn about the effect of the investigational agent tivozanib~     on the control of the tumor growth in hepatocellular (liver) cancer. The investigators also~     plan to collect information on the likelihood to develop side effects while on this~     treatment. Tivozanib is an oral medication (pill) taken once a day. This medication is~     designed to stop the tumor from developing new blood vessels.~   "
134474|NCT01807143|"~     This clinical trial studies genetic biomarkers in tissue samples from patients with~     osteosarcoma. Studying samples of tissue from patients with cancer in the laboratory may help~     doctors learn more about changes that occur in DNA and identify biomarkers related to cancer~   "
134475|NCT01807130|"~     Purpose and Objective: Heart failure therapies including beta-blockers, ACE-inhibitors,~     aldosterone antagonists, implantable cardioverter-defibrillator (ICD) and cardiac~     resynchronization therapy (CRT) devices have proven beneficial but are underused in eligible~     patients. The investigators seek to determine if automating referral to cardiologists and~     electrophysiologists through an intelligent electronic medical record system can improve~     adherence to American College of Cardiology (ACC)/ American Heart Association (AHA) heart~     failure guideline recommended therapies.~      Study activities and population group: The AMERICA-HF trial will be a randomized,~     single-center, single blinded study comparing standard-practice provider initiated~     cardiovascular specialty referral to experimental automated medical record driven~     cardiovascular specialty referral. An investigational program will automatically screen all~     finalized electronic reports from clinically indicated transthoracic echocardiogram studies~     performed in the Duke University Echo Lab system and create an automated query to obtain HF~     ICD-9 codes. Eligible patients will be randomly assigned to participate in a registry (n=125)~     or automated electronic medical record (EMR) based subspecialty care intervention arm~     (n=125).~      Data analysis: The primary endpoint is rate of adherence (%) to ACC/AHA HF guideline~     recommended therapies at 3, 6, and 12 month follow-up among patients randomized to the~     registry compared to the intervention. Differences in characteristics (including use of~     guideline recommended therapies) will be tested using Pearson Chi-square tests for~     categorical variables and Wilcoxon two-sample tests for continuous variables. Time to event~     analysis will be performed for the secondary endpoints of hospitalization or death.~   "
134476|NCT01807117|"~     This pilot clinical trial studies positron emission tomography (PET)-magnetic resonance~     imaging (MRI) and PET-computed tomography (CT) as diagnostic imaging in patients with colon~     and/or rectal cancer. New diagnostic imaging procedures, such as PET-MRI, may help find and~     diagnose rectal cancer or recurrence of colorectal cancer~   "
134477|NCT01807104|"~     The purpose of this study is to compare the short term effectiveness and return to function~     of subjects undergoing primary Total Hip Arthroplasty using an Anterior Approach (incision on~     the front part of the hip joint) versus Posterior Approach (incision over back part of the~     hip joint).~   "
134478|NCT01807091|"~     This pilot clinical trial studies the feasibility of having induction chemotherapy in an~     outpatient setting. Patients with acute leukemia (AML) or advanced myelodysplastic syndrome~     (MDS), at least 18 years of age will be examined. Treating eligible patients with induction~     chemotherapy in an outpatient setting may save in healthcare cost and improve a patients'~     quality of life.~   "
134479|NCT01807078|"~     Treatment with statins has a class I indication after percutaneous coronary intervention~     (PCI), but is often discontinued by patients due to side effects.~      Pharmacologic alternatives shown to be useful after PCI include ezetimibe and nutraceuticals~     (i.e. compounds derived from foods with cholesterol lowering actions).~      It remains unknown, however, which of these two therapeutic approaches is more effective~     after PCI.~      The primary objective of this study is to compare the efficacy and tolerability of ezetimibe~     vs. a nutraceutical-based protocol in statin-intolerant patients treated with percutaneous~     coronary intervention.~   "
134480|NCT01807065|"~     This randomized phase II trial studies how well giving sipuleucel-T with or without radiation~     therapy works in treating patients with hormone-resistant metastatic prostate cancer.~     Vaccines may help the body build an effective immune response to kill tumor cells. Radiation~     therapy uses high energy x rays to kill tumor cells. It is not yet known whether giving~     sipuleucel-T vaccine is more effective with or without radiation therapy in treating prostate~     cancer~   "
134481|NCT01807052|"~     This trial studies biomarker expression in tissue samples from patients with bone sarcomas.~     Studying biomarker in tissue samples from patients with cancer in the laboratory may help~     doctors identify and learn more about biomarkers related to cancer~   "
134482|NCT01807039|"~     Proximal femoral fractures are most frequent traumatologic and orthopedic diagnoses~     undergoing surgery. It affect most seniors and accompanied by a series of complications. The~     aim of our retrospective clinical trial is to establish a thirty-day mortality rate after~     surgical solutions, mortality during hospitalization and compare the types of anesthesia~     chosen during the performance (general vs. subarachnoid anesthesia).~   "
134483|NCT01807026|"~     This study is being done for the following reasons:~      To determine the safety of LY2886721 and any side effects that may be associated with it and~     to see how much of the study drug is in the blood and the cerebrospinal fluid when one dose~     is given to healthy participants and participants diagnosed with Alzheimer's disease. It will~     also look at how safe and tolerable the study drug is when given to healthy participants in~     higher doses.~      This research study is being conducted in three groups, referred to as Groups (Cohorts) A, B~     or C.~      Group A will enroll participants with Alzheimer's disease while Groups B and C will enroll~     healthy participants.~      For Group A or B, participation in this research study could last up to 34 days. For Group C,~     participation could last up to 60 days.~   "
134484|NCT01807013|"~     Prospective study to evaluate the dignostic value of b-mode ultrasound, elastometry and~     mini-laparoscopic guided liver biopsy for the diagnosis of compensated liver cirrhosis.~   "
134485|NCT01807000|"~     Phase I study to evaluate the excretion of radioactivity, the metabolic profile,~     pharmacokinetics, safety and tolerability following a single oral administration of [14C]~     Prucalopride Succinate in healthy male volunteers aged 18 to 50 years (inclusive).The purpose~     of this study is to investigate how and how quickly Prucalopride Succinate or its break down~     products are excreted by analysing blood, faeces and urine samples collected during the~     study.~   "
134486|NCT01806987|"~     The purpose of this project to determine whether the KITS Program, an intervention to improve~     early literacy, prosocial and emotion and behavior regulation domains of school readiness,~     improves school readiness and school outcomes in children from socioeconomically~     disadvantaged neighborhoods.~   "
134487|NCT01806974|"~     Rheumatoid arthritis and periodontitis are two inflammatory diseases that share many~     pathophysiological similarities as some inflammatory mediators like TNF-alpha, IL-1, Il-6,~     Il-17, Il-12 et Il-17, RANK-L, or OPG The most severe or progressive forms of rheumatoid~     arthritis require in 10-30% of cases, the use of biotherapies such as anti-TNF-alpha, anti~     CD-20 and anti-lL-6. All these treatments results in, among other things, an increased risk~     of infection, both viral and bacterial.~      These new biotherapies could have an impact on periodontal status~        -  either by favouring sub gingival colonization of root surfaces by periodontal pathogenic~          bacteria and initiate periodontitis or exacerbate pre-existing periodontitis,~        -  or a positive modulation of the host response by inhibiting bone resorption of the~          alveolar process.~      To date, very few studies have been conducted on this subject which is really a translational~     research, involving several medical specialties.~   "
134488|NCT01806961|"~     Determine the recurrence rate of actinic keratosis (AK) lesions in patients with complete~     clinical clearance at the end of the previous trial SP848-AK-1101 at 6 and 12 months of~     follow-up.~   "
134489|NCT01806948|"~     We randomized patients who received laparoscopic surgery for benign gynecologic disease into~     double dose (Experimental Group) or single dose (Control Group) of antiemetics. We compared~     the degree of postoperative nausea and vomiting in experimental and control groups.~   "
134490|NCT01806935|"~     The purpose of the study is to assess the the effect of the study product on itching symptoms~     associated with xerotic dermatitis in aged population~   "
134491|NCT01806922|"~     Hypothesis: This study investigated the hypothesis that subacute and chronic stroke patients~     who received a combination of yoga and traditional physiotherapy were getting more~     improvement in standing balance than traditional physiotherapy. And we also hypothesis yoga~     can improve post-stroke depression symtom.~   "
134492|NCT01806909|"~     Background:~        -  Adenoviruses are viruses that typically cause symptoms of a cold or eye infection. These~          viruses are being tested as part of a possible new vaccine. Researchers hope that the~          adenovirus will help carry the vaccine into the body and cause an immune response. An~          immune response is the body s release of cells and substances that protect the body from~          infection. If an adenovirus vaccine can be developed, it might be used as part of a~          vaccine for malaria or other serious illnesses. Researchers want to test the adenovirus~          vaccine as a nasal spray in healthy volunteers. The vaccine is called AD4-H5-VTN.~        -  Because the vaccine contains a live adenovirus, there is a possibility that participants~          can infect other people. Therefore, participants' intimate contacts must join this~          study. An intimate contact is someone who the participant will kiss on the mouth or have~          sexual intercourse with during the period of this study.~      Objectives:~        -  To study the immune response of the AD4-H5-VTN vaccine in healthy volunteers.~        -  To see if the adenovirus in the AD4-H5-VTN vaccine is contagious or spreads to others.~      Eligibility:~        -  Healthy volunteers between 18 and 49 years of age.~        -  Intimate contacts of healthy volunteers between 18 and 65 years of age.~        -  Participants must not have evidence of previous exposure to adenovirus type 4.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected.~        -  Participants who will receive the vaccine must be willing to be hospitalized for between~          5 and 7 days. They will come to the National Institutes of Health for follow-up visits~          weekly for the first month, after 8 weeks, in 6 months, and possibly 1 year. They must~          also avoid all vaccines (including seasonal flu vaccine) and allergy shots for 30 days~          before and after having the study vaccine.~        -  Participants will enter the hospital for the vaccine study visit. They will receive the~          vaccine as a nasal spray. Because the vaccine uses a live virus, participants may be~          contagious for the virus for up to 4 weeks. They will remain in the hospital in~          respiratory isolation for 7 days, or until they have two negative nasal washes taken 1~          day apart. A negative nasal wash means that there is no live virus in the nose.~        -  After leaving the hospital, participants will keep a diary at home for at least 3 weeks.~          They will record their temperature, any symptoms, or other health changes every day~          during this time.~        -  Participants should avoid intimate contact with others for 28 days after having the~          vaccine. Intimate contact includes kissing on the mouth and sexual intercourse. Also,~          participants should not share kitchen utensils, drinking cups, towels, or hair combs~          with others. Intimate contacts will also keep track of any illnesses or symptoms they~          develop during this time.~        -  At the follow-up visits, participants will provide blood and swab samples for study.~   "
134493|NCT01806896|"~     This study will evaluate the Safety, Tolerability and Brain Function of 2 doses of PF-0254920~     in Subjects with Early Huntington's Disease.~   "
134494|NCT01806883|"~     The purpose of this study is to evaluate changes in strategies of hemiparetic upper limb~     movement in chronic stroke patients following rehabilitation using the Nintendo Wii. The~     investigators hypothesize that patients will increase their use of compensatory strategies~     following this rehabilitation.~   "
134495|NCT01806870|"~     The purpose of this study is to see if taking two nutritional supplements, zinc and SAMe~     (S-adenosylmethionine), can improve lung health and immune function in persons with HIV. You~     are being asked to volunteer because you have HIV (Human Immunodeficiency Virus) and you take~     anti-retroviral therapy (ART) medications.~   "
134496|NCT01806857|"~     The purpose of this study is to determine whether Nuedexta is effective in the treatment of~     symptoms (impaired speech, swallowing, and saliva control)associated with Amyotrophic Lateral~     Sclerosis (ALS).~   "
134497|NCT01806844|"~     Near infrared spectroscopy (NIRS) is a technique that measures regional cerebral oxygenation~     in a non-invasive manner. Through the use of near infrared light, the difference between~     oxygenated and deoxygenated hemoglobin can be measured. By applying the Beer-Lamber law, a~     numeric result can be calculated. During a cardiac arrest, there is no stroke volume, no~     cardiac output and no cerebral perfusion. By using cerebral NIRS during out-of hospital~     cardiac arrest, low flow time and return of spontaneous circulation, this study wants to show~     the prognostic value of NIRS as extra monitoring.~   "
134503|NCT01806766|"~     The purpose of this prospective, randomized study was to compare the clinical and~     radiographic results and the prevalence of osteolysis of the cementless total hip~     arthroplasty with an alumina-on-alumina bearings one side and alumina-on-highly cross-linked~     polyethylene bearings on the other side in the young and active patients.~   "
134504|NCT01806753|"~     Although proper sedation is mandatory for endoscopic procedures such as endoscopic submucosal~     dissection, the effects of sedation on ESD performance and complications have not been fully~     evaluated. In the investigators previous retrospective study, en bloc resection and complete~     resection rates, and procedure time could be improved by sedation with continuous propofol~     infusion with opioid administration by anesthesiologists. However, there are several~     limitations to the study including retrospective design. The investigators aimed to evaluate~     the relationship among sedation methods, satisfaction of endoscopists or patients, clinical~     outcomes, and complications after endoscopic submucosal dissection for gastric neoplasia.~   "
134505|NCT01806740|"~     Primary objective :~      The main objective is to evaluate the value of DCE-MRI in prediction of response of patients~     with HCC to treatment with Sorafenib assessed by mRECIST.~   "
134506|NCT01806727|"~     This study is evaluating two approaches to improving the control blood sugar, and other risk~     factors for heart disease in overweight and obese adults with type 2 diabetes. The first~     approach has participants focus on weight loss via reducing food intake and increasing~     physical activity, while attending weekly group sessions led by trained community health~     workers for 12 months. The second approach has participants receive education on diabetes~     self management, which focuses primarily on glucose control, while attending monthly group~     sessions led by a study staff member for 12 months. We are recruiting persons with type 2~     diabetes who live in the Winston-Salem/Forsyth County area of North Carolina who are willing~     to attend sessions at the Downtown Health Plaza of Wake Forest Baptist Health. We will~     measure risk factors for heart disease (glucose control, blood pressure, blood cholesterol)~     and calculate the predicted risk of heart disease, and see which intervention lowers risk to~     a greater extent at 12 months, as well as 24 months.~   "
134507|NCT01806714|"~     The purpose of the study is to evaluate the effectiveness of a managed care-based HPV~     vaccination reminder/recall system using a randomized controlled trial (RCT) across diverse~     practices and patient populations. The trial will measure the effectiveness of text messaging~     reminder/recall on (a) improving initiation and (b) completion rate of the HPV vaccine~     series; (c) decreasing the time between vaccine doses; and (d) improving rates of preventive~     visits for adolescents~      The hypotheses are that text-messaged reminders to parents of adolescents will result in~     improved rates of HPV vaccine series initiation, HPV vaccine series completion, will decrease~     the intervals between vaccine doses and will improve rates of preventive care among~     adolescents. Parents receiving specific text-messaged reminders about services (i.e. HPV~     vaccination, well child care visits) for which their adolescent is due will be compared to a~     control group of parents receiving general health tips through text messages.~   "
134508|NCT01806701|"~     This study will examine how brain activation changes as a result of behavioral treatment for~     posttraumatic stress disorder (PTSD) in adolescents. The investigators will conduct~     functional magnetic resonance imaging (fMRI) scans before and after the widely-used~     trauma-focused cognitive behavioral therapy to better understand how the brain recovers from~     illness. This study will provide much needed information about brain abnormalities in abused~     youth, and could lead to improvements in behavioral treatments for patients who do not~     respond to current treatments.~   "
134509|NCT01806688|"~     This clinical trial is being conducted to study whether eating certain snacks will reduce~     your desire to eat and for a longer period of time compared to other snacks. The~     investigators are testing 2 different snacks. Study #1 will involve eating 2 different~     seed-like snacks or water. Study #2 will involve eating pita bread with jam, bread with jam~     or water. The test snack is higher in protein and/or fibre compared to the reference product.~   "
134510|NCT01806675|"~     The purpose of the study is to conduct research of a new PET radiopharmaceutical in cancer~     patients. We will assess the uptake of this novel radiopharmaceutical in subjects with breast~     cancer, lung cancer, glioblastoma multiforme (GBM) and other cancers requiring~     antiangiogenesis treatment.~   "
134511|NCT01806662|"~     Atopic dermatitis (AD) is a chronic disease associated with intense itching, which affects~     most aspects of everyday life in the majority of patients. Acute inflammation and~     extensor/facial involvement is common in infants, whereas chronic inflammation increases in~     prevalence with age, as do localization to flexures. AD has a complex background~     characterized by immune activation, increased epidermal thickness in chronic diseased skin,~     and defective barrier function. In normal, healthy skin, the outer layer of the epidermis,~     the stratum corneum is made up flattened dead cells called corneocytes held together by a~     mixture of lipids and proteins. The stratum corneum and, in particular, the lipid layer are~     vital in providing a natural barrier function that locks water inside the skin and keeps~     allergens and irritants out. In people with AD, the barrier function is defective, which~     leads to dry skin. As the skin dries out, it cracks allowing allergens and irritants to~     penetrate.~      Mild AD can be controlled with emollients and topical medications. However, moderate to~     severe AD is extremely difficult to control and requires systemic treatment that is often~     unsatisfactory due to impracticality and lack of effectiveness. Only three therapeutic~     options exist for moderate to severe AD, including: 1) oral steroids 2) cyclosporine A (CsA),~     that is not widely used in the US as it is not FDA approved for AD and 3) ultraviolet~     phototherapy. Oral steroids and CsA treatments have major side effects and UV radiation~     therapy is highly inconvenient for patients. Several biologic medications, such as TNF-alpha~     inhibitors, are effective, convenient, and relatively safe therapies for psoriasis, but have~     thus far not shown efficacy in AD. Ustekinumab is a unique biologic medication that may~     specifically target AD.~      The investigators study will determine whether there is a reversal of the skin thickness and~     the immune pathways involved in the disease during treatment with Ustekinumab and what~     specific immune cells are involved. The investigators are also interested to understand how~     the clinical reversal of the disease will correlate with tissue reversal of the disease.~   "
134512|NCT01806649|"~     There is a need for more effective therapy for patients with esophageal squamous cell~     carcinoma who developed disease progression after first line therapy. Currently, there is no~     standard second-line therapy for this disease.~      BKM-120 is a pan-PI3K inhibitor currently tested in clinical trials. In a cellular model of~     oral-esophageal carcinogenesis, it has shown that EGFR overexpression activated PI3/AKT~     pathway. Therfore, there is interest to see the efficacy and safety of BKM120 in this~     setting.~   "
134513|NCT01806636|"~     This registry is a post market observational, prospective, multi-center registry. It is~     designed to evaluate patient experience with the RePneu™ device for the relief of the~     emphysema symptoms and the continued collection of safety and effectiveness data on this CE~     Mark product. In addition, the registry will collect information that will serve as the~     foundation for a cost effectiveness analysis.~   "
134514|NCT01806623|"~     As for the indication of vulvovaginal candidiasis, a single oral administration of~     fluconazole 150 mg has been approved and is recommended by guidelines overseas. However in~     Japan oral therapy with antifungal triazole such as Fluconazole has not been approved, and~     topical therapies such as vaginal tablets, pessary and cream are used clinically. The purpose~     of this trial is to confirm the efficacy and safety of single oral administration of~     fluconazole 150 mg for the treatment of vulvovaginal candidiasis in Japanese patients.~   "
134515|NCT01806610|"~     The purpose of the study is to evaluate the safety, tolerability, and PK following a single~     administration of BPS804 in patients with chronic kidney disease stage 5D (CKD-5D) on~     hemodialysis.~   "
134516|NCT01806597|"~     Purpose of the study was to demonstrate the efficacy of secukinumab versus placebo on~     palmoplantar psoriasis and to assess the long term efficacy, safety and tolerability of~     secukinumab.~   "
134517|NCT01806584|"~     A study to evaluate the efficacy of SRM003 treatment versus participating sites' standard~     practice treatment in extending the duration of primary patency after arteriovenous graft~     surgery in subjects with end-stage renal disease.~      It is hypothesized that when placed outside the blood vessel, the seeded SRM003 gelatin~     matrix containing endothelial cells can provide a continuous supply of multiple growth~     regulatory compounds to the underlying cells within the blood vessel, while being protected~     from the effects of blood flow in the vessel(s) or complications resulting from being in~     direct contact with the point of injury.~   "
134518|NCT01806571|"~     This phase II trial studies how well daunorubicin hydrochloride, cytarabine, and nilotinib~     work in treating patients newly diagnosed with acute myeloid leukemia. Drugs used in~     chemotherapy, such as daunorubicin hydrochloride and cytarabine, work in different ways to~     stop the growth of cancer cells, either by killing the cells, by stopping them from dividing,~     or by stopping them from spreading. Nilotinib may stop the growth of cancer cells by blocking~     some of the enzymes needed for cell growth. Giving daunorubicin hydrochloride with cytarabine~     and nilotinib may kill more cancer cells.~   "
134519|NCT01806558|"~     A combined molecular breast imaging / ultrasound system will enable coregistration of a~     functional abnormality seen on Molecular Breast Imaging (MBI) with the corresponding~     anatomical abnormality seen on ultrasound.~   "
134520|NCT01806545|"~     A study to evaluate the efficacy of SRM003 treatment versus participating sites' standard~     practice treatment in improving the rate of AVF maturation and use in subjects with end-stage~     renal disease undergoing surgery for creation of an AVF to facilitate hemodialysis access.~      It is hypothesized that when placed outside the blood vessel, the seeded SRM003 gelatin~     matrix containing endothelial cells can provide a continuous supply of multiple growth~     regulatory compounds to the underlying cells within the blood vessel, while being protected~     from the effects of blood flow in the vessel(s) or complications resulting from being in~     direct contact with the point of injury.~   "
134521|NCT01806532|"~     The goal of this study is to investigate acute respiratory distress syndrome (ARDS) and~     septic lung with positron emission tomography (PET) imaging and to examine the distribution~     of inflammation, as measured by neutrophil metabolic activity.~   "
134522|NCT01806519|"~     Neck pain is a common problem in the western world. There is a group of people suffering from~     neck pain with a reduced ability to maintain an upright posture showing a forward head~     position and an altered muscle function.~      The aim of the study was to evaluate a motor control intervention for patients with~     persistent neck pain and a forward head posture.~      This pilot study used a Single System Experimental Design (SSED) with an A-B-A-design and~     multiple baselines.~      The tailored motor control intervention addressed the faulty postural alignment and the deep~     muscles of the cervical spine.~   "
134523|NCT01806506|"~     Bariatric surgery is the most effective treatment for morbid obesity. Roux-en-Y gastric~     bypass (RYGB) is a bariatric procedure with known safety and effectiveness. Laparoscopic~     sleeve gastrectomy (LSG) is a newer procedure gaining popularity. The aim of the study is to~     compare outcomes of these two surgical methods in terms of weight loss, improvement of common~     comorbidities of obesity and influence on metabolic and hormonal status.~   "
134524|NCT01806493|"~     The prevalence of individuals who are classified as overweight or obese is increasing all~     over the world and it represents a primary health concern due to the relationship between~     obesity and a number of diseases, disabilities, comorbidities, and mortality. The definition~     of obesity should consider not only the increase of body weight but more precisely the~     increase in body fat mass. However, body composition evaluation is rarely performed in~     overweight and obese subjects and the diagnosis is almost always achieved just considering~     body mass index (BMI). In fact, whereas BMI can be considered an important tool in~     epidemiological surveys, different papers stated the limitations of the use of BMI in single~     individuals.~      Aim: to assess the determinants of body composition in a population of overweight and obese~     subjects and to propose a different model of estimation of fat mass (FM) in these subjects~     when more reliable equipments for the evaluation of body composition are not available.~      Methods: in 103 overweight or obese subjects ( 74 women, aged 41.5±10 years, and 29 men, aged~     43.8±8 years); a multidimensional evaluation was performed including the assessment of body~     composition using Dual Energy X-Ray Absorptiometry (DXA), anthropometry, bioimpedance~     analysis (BIA) and biochemical parameters (total cholesterol, triacylglycerol, HDL- and LDL-~     cholesterol, free fatty acids and glycerol, glucose, insulin, C-reactive protein, plasma~     acylated and unacetylated ghrelin, adiponectin and leptin serum levels).~   "
134539|NCT01806298|"~     This is an open-label, single-arm, multicenter, Phase 4 study to explore the immunogenicity~     of the liquid formulation of Saizen® in subjects with Adult Growth Hormone Deficiency (AGHD),~     who are growth hormone (GH) treatment-naïve or who had prior GH treatment for GHD which was~     stopped at least 1 month prior to Screening and have no contraindication to the use of GH.~   "
134540|NCT01806285|"~     The purpose of this sample collection study is to prospectively collect respiratory viral~     clinical samples, conduct standard of care comparator testing and archive the collected~     residual samples for future testing in order to establish the clinical performance~     characteristics of the investigational instrument.~   "
134879|NCT01801852|"~     The purpose of this study is to assess the safety and effectiveness of natural killer T (NKT)~     cell-based autologous adoptive immunotherapy in subjects with metastatic,~     treatment-refractory breast cancer, glioma, hepatocellular carcinoma, squamous cell lung~     cancer, pancreatic cancer, colon cancer or prostate cancer.~   "
134525|NCT01806480|"~     Although breast milk has numerous benefits for infants' development, with heightened effects~     in those born preterm (at < 37 gestational weeks), mothers of preterm infants have shorter~     breastfeeding duration than mothers of term infants. One of the explanations proposed is the~     difficulties in the transition from a Neonatal Intensive Care Unit (NICU) to the home~     environment. A person-centred proactive telephone support to breastfeeding mothers after~     discharge from NICU is expected to promote mothers' sense of trust in their own capacity and~     thereby facilitate breastfeeding. We hypothesize that proactive (health service initiated)~     telephone breastfeeding support offered to mothers of preterm infants after hospital~     discharge is more effective than reactive (mother initiated, and defined as usual care)~     telephone support at increasing the proportion of mothers who are exclusively breastfeeding 8~     weeks after discharge.~      A multicentre randomized controlled blinded trial has been designed to evaluate the~     effectiveness and cost-effectiveness of person-centred proactive telephone support on~     breastfeeding to mothers of preterm infants. Mothers will be informed about the study before~     discharge. Participating mothers will be randomized to either a control group or intervention~     group, immediately after discharge. Mothers will be notified to what group they have been~     randomized to through phone call or sms, depending on mother's preferences.~        -  Control group: person-centred reactive telephone support where mothers can phone the~          breastfeeding support team up to day 14 after hospital discharge.~        -  Intervention group: reactive support AND person-centred proactive telephone support in~          which the breastfeeding support team phones the mother daily for up to 14 days after~          hospital discharge.~      A stratified block randomization will be used; group allocation will be done on high or low~     SES (i.e. educational level) and by NICU. Recruitment will be performed continuously until~     1116 mothers (I: 558 C: 558) have been included. The data will be collected at eight weeks~     after discharge and at six months of infant's postnatal age using telephone interviews and~     questionnaires. Primary outcome is exclusive breastfeeding at eight weeks after discharge~     from the NICU. Secondary outcomes are breastfeeding (i.e. exclusive, partial, none and~     method), mothers satisfaction with breastfeeding, attachment, stress and quality of life in~     mothers/partners at eight weeks after hospital discharge and at six months postnatal age. A~     qualitative evaluation of experiences of providing/receiving the intervention will also be~     performed with mothers and staff respectively.~   "
134526|NCT01806467|"~     Many mini-invasive devices to monitor cardiac output (CO) have been introduced and among them~     the Pressure Recording Analytical Method (PRAM). The aim of this study is to assess the~     agreement of PRAM with the intermittent transpulmonary thermodilution (ThD) and continuous~     pulmonary ThD in measuring CO in hemodynamically unstable patients.~   "
134527|NCT01806454|"~     the purpose of this study is to determine whether calcium supplementation is effective to~     prevent preeclampsia in Sichuang Province of china and which dose is more suitable~   "
134528|NCT01806441|"~     Dietary fat has been shown to modulate cholesterol and fatty acids homeostasis and several~     lines of evidence suggest that this effect is associated with changes in the regulation of~     different genes at the intestine level involved in the cholesterol and fatty acid metabolism~     pathways. The present study will examine the impact of a short-term high fat diet versus a~     short-term low fat diet on expression of Niemann-Pick C1-like 1 (NPC1L1), adenosine~     triphosphate (ATP) binding cassette transporters (ABCG5/8), microsomal triglyceride transfer~     protein (MTP) and fatty acid transport protein-4 (FATP4), which have been shown to play a~     critical role in intestinal cholesterol absorption, chylomicron synthesis and dietary lipid~     absorption. Gene expression studies will be performed on duodenal biopsies. The primary~     hypothesis is that a short-term high fat diet will significantly decrease duodenal messenger~     ribonucleic acid (mRNA) levels of NPC1L1, ABCG5/8, MTP and FATP4 as compared with a~     short-term low fat diet.~   "
134529|NCT01806428|"~     Objective: to test the hypothesis that recombinant activated protein C (aPC) therapy improves~     the microcirculation of severe septic patients.~      Design: Prospective, open study. Setting: University 12-beds intensive care unit. Patients:~     Septic patients with at least two sepsis-induced organ failures occurring within 48 hours of~     the onset of sepsis were included in a one year period.~      Interventions: Patients who had no contraindication to aPC administration received aPC at a~     dose of 24 mcg/kg/h for 96 hours. Patients with contraindications to aPC infusion were~     considered as controls.~   "
134530|NCT01806415|"~     This is a randomized, blinded, parallel group, placebo-controlled trial on 32 evaluable~     healthy male and non-pregnant female, 18-50 year old volunteers. The investigators goal is to~     observe the pharmacokinetics of fenobam after oral administration of 50, 100 or 150 mg in~     groups of healthy individuals and to compare the side effects and tolerability of a single~     dose of fenobam with placebo.~   "
134531|NCT01806402|"~     The purpose of the study is to repeatability, reproducibility and agreement of eye~     measurements in retina and glaucoma patients.~   "
134532|NCT01806389|"~     Goals: The overarching goals for this proposed research are to provide pilot data for a study~     to inform the FDA regarding the safety of breastfeeding infants of mothers on buprenorphine~     maintenance and to develop guidelines for the practitioner treating buprenorphine maintained~     women who wish to breastfeed.~      Background: There is an increase in the prevalence of illicit opiate use among women of~     childbearing age. Recently, a large multisite study has suggested buprenorphine as an~     alternative to methadone for use in this population. As a consequence, buprenorphine is~     likely to be delivered to larger populations of pregnant and post-partum women. The~     population of prenatally opioid-exposed neonates is a particularly vulnerable population.~     Advances in neuroscience, molecular biology and epigenetics indicate that greater attention~     should be given to strategies that prevent, reduce, or mitigate the consequences of~     significant adversity on the developing brain. Breast milk and breastfeeding offer~     significant health and other benefits that are particularly salient for this group. Today,~     there is a near complete lack of information regarding the safety of buprenorphine~     maintenance and lactation, making it unlikely that providers will endorse or mothers will~     adopt this practice.~      Methods: Five pregnant buprenorphine maintained breastfeeding women and their neonates will~     be enrolled. Subjects will selected by buprenorphine maintenance in the postpartum period and~     enrollment in a parent protocol and by decision to breast feed their infants. Subject will~     provide breast milk at times of peak maternal buprenorphine levels on days 2, 3, 4, 14 and 30~     after delivery to determine buprenorphine and norbuprenorphine concentrations. Subjects will~     also provide plasma at times of peak buprenorphine levels for determination of buprenorphine~     and norbuprenorphine concentrations on the same days. Concentrations of buprenorphine and~     norbuprenorphine in the plasma of infants will be determined on approximately day 14 of life.~     The relationship between maternal dose, maternal and infant plasma concentrations, and breast~     milk concentrations of buprenorphine and norbuprenorphine will be determined, and ingestible~     infant dose calculated.~   "
134533|NCT01806376|"~     1. purpose: to explore the maximum tolerated dose, dose-limiting toxicity of oral Subutinib~          Maleate capsules and rational dosage regimen for phase Ⅱ study~        2. Experimental Design： A phase Ⅰ study of single-center~        3. Test drug: Subutinib Maleate capsules~        4. Sample size≥20~   "
134534|NCT01806363|"~     Clinical trial to evaluate the pharmacokinetic interactions and safety between telmisartan~     and chlorthalidone.~   "
134535|NCT01806350|"~     This randomized pilot clinical trial studies pelvic floor muscle training in treating urinary~     incontinence in gynecologic cancer survivors. Pelvic floor muscle training may help control~     symptoms and improve physical function and quality of life in gynecologic cancer survivors.~   "
134536|NCT01806337|"~     Prospective Phase II Study for Treatment Peripheral T-cell Lymphoma, CHOP-14 Plus~     PEG-Filgrastim Followed by Alemtuzumab Consolidation~   "
134537|NCT01806324|"~     The objective of this study is:~      To evaluate the pharmacokinetics and safety of an experimental combination tablet containing~     20 mg atorvastatin and 50 mg losartan potassium when administered orally as a single dose to~     healthy male subjects, compared with the concomitant administration of 20 mg atorvastatin and~     50 mg losartan potassium tablets.~   "
134538|NCT01806311|"~     Clinical trial to evalate the pharmacokinetic interactions and safety between single dose of~     amlodipine10mg and candesartan32mg and combiation dose amlodipine10mg with candesartan32mg in~     healthy male volunteers.~   "
134541|NCT01806272|"~     This is a open,randomized phase II trial comparing effectiveness and safety of local use of~     rhGM-CSF and Compound Vitamin B12 to Compound Vitamin B12 solution alone treating oral~     mucositis in primary nasopharyngeal cancer. The main end point is the incidence of grade II~     and less oral mucositis at the end of treatment.The hypothesis of the study is that the local~     use of rhGM-CSF and Compound Vitamin B12 can decrease the incidence of grade III and more~     oral mucositis at the end of treatment compared to local use of Compound Vitamin B12 alone.~   "
134542|NCT01806259|"~     Do the use of Ketorolac in one intravenous injection at the moment of the operative incision~     reduce the number of recurrence in patient with advanced breast cancer without inflammation~     signs.~   "
134543|NCT01806246|"~     The aim of the programme is to develop a treatment model for adolescents with Chronic Fatigue~     Syndrome. The program consists of 4 elements lasting for 12 months, psychoeducation~     reflecting the current knowledge about the disease, Heart Rate Variability Coherence~     Biofeedback, pacing and activity planning and some principles of cognitive behaviour therapy.~     The study is designed as a Single-Case study including 10- 15 participants.~   "
134544|NCT01806233|"~     There will be successive changes in traditional Chinese medicine rehabilitation for stroke~     patients with limb hemiparetic through therapy of acupuncture and moxibustion.~   "
134545|NCT01806220|"~     -  Saliva plays an important role in the homeostasis of the digestive tract mucosa.~        -  Salivary organic components, such as the Epidermal Growth Factor(EGF) have been found in~          defficient concentrations in patients with gastroesophageal reflux disease (GERD) and~          reflux related laryngitis (LPR).~        -  The epidermal growth factor receptor (EGFR) signaling pathway is one of the most~          important pathways that regulate growth, survival, proliferation, and differentiation in~          mammalian cells~        -  Eperdermal growth factor receptor (EGFR) overexpression has been linked to~          hyperproliferative diseases.~        -  It is unknown if the inflammatory process in GERD is realated to difficiencies in EGFR~          expression.~        -  The objective of the current study was to try to establish a correlation between the~          expression of EGFR in the laryngeal and esophageal mucosa and the severity of laryngitis~          in adults with GERD and LPR~   "
134546|NCT01806207|"~     This was a study that compared Durolane injections to saline injections in the treatment of~     unilateral osteoarthritis of the knee. The patients were randomly assigned one of the two~     treatments unaware of which treatment they received. The study was conducted at 13 centers in~     Germany, the United Kingdom and Sweden. Patients were followed for six weeks after study~     treatment.~   "
134547|NCT01806194|"~     The EMPOWER diabetes program is a year-long, community-based program designed to enhance~     diabetes management in rural African American women with uncontrolled diabetes. The treatment~     is delivered by community peers and follows a relative Small Changes approach.~   "
134548|NCT01806181|"~     This study will offer a supervised exercise program and healthy eating education to women~     with breast cancer undergoing chemotherapy as a physician-referred program and measure the~     adoption, adherence and satisfaction with the intervention as well as its health effects.~     Past trials have demonstrated various health benefits of exercise yet it is not currently~     part of supportive care and few suitable programs exist in the community or outside of~     research. This study is expected to address the unique barriers related to exercise in breast~     cancer survivors and to better understand how the intervention might work in a real life~     setting.~   "
134549|NCT01806168|"~     The purpose of this study is to assess the effects of repetitive transcranial magnetic~     stimulation (rTMS) in civilian patients with a confirmed diagnosis of post-traumatic stress~     disorder (PTSD). This research study will determine whether low-frequency (1 Hertz [Hz]) or~     high-frequency (10 Hz) rTMS over the right dorsolateral prefrontal cortex (DLPFC) has an~     effect on symptoms of PTSD compared to sham rTMS treatment.~   "
134550|NCT01806155|"~     Headache after major craniotomy may be a problem in taking care of the patients. The~     investigators want to identify the incidence of headache after major craniotomy and also the~     risk factors.~   "
134551|NCT01806142|"~     Several lines of evidence indicate that a significant proportion of cardiovascular disease~     (CVD) events are attributable to the presence of a cluster of metabolic abnormalities and~     perturbations, defined as the metabolic syndrome. It has been estimated that approximately~     25% of the North American adult population is living with the metabolic syndrome. Recent~     studies from the investigators group show that overaccumulation of atherogenic~     triglyceride-rich lipoproteins (TRL) seen in insulin-resistant patients is partly due to~     increased production rate of intestinally derived apolipoprotein (apo) B-48-containing~     lipoproteins. This is of interest because substantial evidence exists indicating that~     elevated levels of intestinal lipoproteins are associated with increased CVD risk. In this~     regard, there is some evidence that medium-chain triglycerides (MCTs) may beneficially modify~     lipoprotein metabolism in hypertriglyceridemic patients. However, as emphasized in the body~     of this grant proposal, the specific impact of MCTs on the intestinal lipoprotein secretion~     and on expression of genes that regulate intestinal lipid absorption and chylomicron~     synthesis has not yet been investigated in humans.~      The general objective of the proposed research is to investigate the mechanisms by which MCTs~     beneficially modify intestinal lipoprotein metabolism in patients with the metabolic~     syndrome. The primary hypothesis is that MCT supplementation will decrease plasma levels of~     intestinal lipoproteins by reducing secretion of these particles.~   "
134552|NCT01806129|"~     This clinical trial studies reproductive health program in patients with cancer. A~     reproductive health program may improve patients' understanding of reproductive risks and~     receipt of appropriate treatment to achieve their reproductive health goals~   "
134553|NCT01806116|"~     Allogeneic stem cell transplantation (SCT) is the only potentially curative therapy for~     patients with myelodysplastic syndrome (MDS) and acute myeloblastic leukemia (AML). Relapse~     remains a leading cause for treatment failure after hematopoietic cell transplantation (HCT)~     in patients，so that there is the need to continue to look for alternative therapies.~     Decitabine, is known to inhibit DNA methyltransferase which results in DNA hypomethylation~     and expression of silenced genes including those involved in apoptosis. The approval of~     decitabine for the treatment of MDS and AML has provided an alternative strategy to inhibit~     disease progression in transplant-eligible patients. To assess the effect of pretransplant~     decitabine treatment on post transplant outcomes, we recently reviewed our institutional~     experience with MDS and AML patients.~   "
134557|NCT01806064|"~     Phase 1b: To evaluate safety and tolerability and determine a recommended phase 2 dose for~     TRC105 when added to standard dose axitinib in patients with advanced renal cell carcinoma.~      Phase 2: To estimate the PFS of patients with advanced or metastatic RCC by RECIST 1.1~     criteria in patients treated with axitinib and TRC105 compared to those treated with axitinib~     alone, following failure of one prior VEGF TKI~   "
134558|NCT01806051|"~     This self-controlled, prospective, pilot study is designed to gather information regarding~     the diurnal variation (changes that occur each day) in the levels of plasma phenylalanine~     (Phe) and tyrosine in patients with phenylketonuria (PKU) and in the non-PKU population.~   "
134559|NCT01806038|"~     The goal of this study is to investigate whether pharmacist provided counseling and~     medication dispensing at the patient's bedside can provide better outcomes than the current~     discharge process at Duke University Hospital. This study will be single-site, prospective,~     randomized, cohort study. Patients who meet the inclusion and exclusion criteria, and provide~     consent will be included in this study.~   "
134560|NCT01806025|"~     Cystic Fibrosis is a genetic disease with variable severity, and a predisposition for lung~     infection. Usually severity is determined by the class of CF mutations, but even among~     patients with the same severity of mutations there is a variation of the severity of CF.~      Haptoglobin has several types (phenotypes), one of them was found to be related to infectious~     complications.~      In this study the investigators aim to find a correlation between Haptoglobin phenotypes in~     patients with CF and frequency of infectious complications.~      To this end the investigators will collect serum from CF patients, and determine their~     Haptoglobin protein phenotype. The investigators will correlate Haptoglobin phenotype to~     retrospectively gathered data on infectious complications.~   "
134561|NCT01806012|"~     The use of the EnSeal® instrument for laparoscopic supracervical hysterectomy in a~     randomized, single-blinded comparison to the conventional procedure. The objective of the~     study is to investigate if the use of the Enseal sealing instrument for supracervical~     hysterectomy leads to a shortening of the operation time.~   "
134562|NCT01805999|"~     Chronic constipation is a phenomenon which affects nearly 20% of the population worldwide.~     Bulking agents such as ispaghula are used as treatments, but only half of the patients are~     satisfied with the treatment. This highlights a need for better treatment options, which~     requires a deeper understanding of the gastrointestinal fate of the products. The GI MRI~     Research group at the University of Nottingham has been developing new, non-invasive magnetic~     resonance imaging (MRI) techniques to image the gastrointestinal tract. In collaboration with~     Ironwood Pharmaceuticals, the investigators now want to understand the gastrointestinal fate~     of an ispaghula treatment, and also to improve the understanding of MRI parameters when they~     are applied to the colon.~   "
134563|NCT01805986|"~     Magnetization transfer imaging is a magnetic resonance technique that has been used over the~     last few years, and known for its ability to detect abnormalities that can be difficult to~     detect by conventional MRI techniques.~      The investigators would like to test if using an 7 Tesla MRI research scanner can help us~     diagnose Multiple Sclerosis more efficiently compared to the current clinical practice, i.e.~     if Multiple Sclerosis lesions in Gray Matter can be more readily identified and associated~     with disease stage on Magnetic Transfer MRI images as opposed to conventional procedures.~     Image analysis will allow the investigators to perform lesion segmentation and sequence~     comparison between different MRI techniques. The investigators will apply computation~     techniques to measure the local cortical thickness. Repeated scans at 6 monthly intervals~     over two years will give an insight into the changes in cortical thickness over time. Based~     on obtained data the investigators will look for the relationship between lesion loads in~     White Matter and Gray Matter, cortical thickness and disease stage.~   "
134564|NCT01805973|"~     An abdominal aortic aneurysm (AAA) is an enlargement or ballooning of the main artery~     supplying high pressure blood from the heart to the body. AAAs may continue to stretch until~     they burst (rupture) causing 7000 deaths per year in the United Kingdom (UK); 2.1% of all~     deaths in men over 65. Planned repair before rupture is critical and the National AAA~     Screening Programme (NAAASP) is being introduced to identify AAAs in men before rupture.~     Screening will identify over 9000 men per year with a previously undiagnosed AAA. More than~     90% of screen detected AAAs are small, do no require repair, enter ultrasound follow-up~     (surveillance) and may benefit from exercise to improve fitness before repair.~      Over 4000 elective AAA repairs per year are performed in the UK and it has been suggested~     that exercise training and weight loss may reduce mortality and complications of AAA repair.~     This pilot study will examine the feasibility of supervised exercise training for patients~     with AAAs and determine the optimal duration of training to achieve worthwhile improvements~     in fitness.~   "
134565|NCT01805960|"~     The purpose of this study is to test the efficacy of a single injection of Canakinumab on AF~     recurrences within 6 months after electrical cardioversion in patients with persistent AF.~   "
134566|NCT01805947|"~     In this observational study the effects of a Lifestyle Modification Program - offered as a~     semi-residential day care clinic - on pain, disability, quality of life and satisfaction with~     life will be investigated. Furthermore the influence of mindfulness, acceptance and coping,~     and acquired changes in lifestyle behaviors on the outcome after the program will be~     evaluated.~      Effects will be measured after completion of the program (3 months), and at 6 and 12 months~     follow up after start of the program, i.e. each outcome measure will be taken 4 times within~     12 months.~   "
134567|NCT01805934|"~     The eradication rates of first-line treatment for Helicobacter pylori(Hp) infection are not~     satisfactory. The study aims to compare the efficacy and safety between quadruple therapy~     with furazolidone and dual therapy with high doses of amoxicillin as rescue regimens for Hp.~   "
134577|NCT01805804|"~     Dual chamber pacing is known to induce left ventricle remodeling and may eventually lead to~     heart failure. The investigators aim to test hypothesis that valsartan started immediately~     after dual chamber pacemaker implantation will prevent left ventricle remodeling in twelve~     months long follow up in comparison with placebo. Echocardiographic assessment of left~     ventricle remodeling will be correlated with plasma activity of matrix metalloproteinases and~     their tissue inhibitors, indices of functional capacity such as plasma level of NTproBNP and~     distance in meters during six minute walking test.~   "
134568|NCT01805921|"~     In this study we are testing a new vaccine against Respiratory Syncytial Virus (RSV).~      This virus can cause respiratory infections such as bronchiolitis and pneumonia. It affects~     all ages, but especially infants, adults with a suppressed immune system, and the elderly.~     RSV only infects humans and occurs in epidemics each winter. It is the single most common~     cause of severe respiratory illness in children.~      There is no effective anti-viral medication to treat RSV infections. There is a monoclonal~     antibody, which can be given to 'at-risk' children given by injection on a monthly basis~     during winter to provide short term protection against infection, but it is only partially~     effective and prohibitively expensive. Currently, there is no licensed vaccine to prevent RSV~     infection and there remains a real need to develop a vaccine as a cost-effective method to~     save lives and reduce the cost of disease caused by RSV.~   "
134569|NCT01805908|"~     The general objective of the study is to improve the care of women with Human Epidermal~     Growth Factor Receptor-2 (HER2) positive metastatic or locally advanced breast cancer by~     using a radio-labelled biomarker with whole body Single Photon Emission Computed Tomography~     (SPECT) imaging to predict who will respond to treatment with Trastuzumab.~   "
134570|NCT01805895|"~     The MACH Trial is a pilot study of 400mg minocycline over five days in acute intracerebral~     hemorrhage patients. The study will evaluation the safety and efficacy of minocycline in~     intracerebral hemorrhage patients.~   "
134571|NCT01805882|"~     Background:~      - GS-7977, GS-5885, GS-9669, and GS-9451 are new drugs for treating hepatitis C virus (HCV)~     infection. GS-7977 may help treat the infection when used with other treatments like~     interferon therapy. GS-5885, and GS-9669, and GS-9451 also lower the amount of HCV in the~     body. Researchers want to see whether GS-7977 can be combined with any of the other three~     drugs to treat HCV infection. Some participants will take GS-7977 and GS-5885. Others will~     take GS-7977, GS-5885 and GS-9669 or GS-7977, GS-5885 and GS-9451.~      Objectives:~      - To see whether GS-7977 with GS-5885 alone or in combination with either GS-9669 or 9451 can~     be used to treat HCV infection.~      Eligibility:~      Individuals at least 18 years of age who have chronic HCV infection and have never been~     treated for it.~      Individuals at least 18 years of age who have chronic HCV infection and have not responded to~     interferon therapy.~      Individuals at least 18 years of age who have chronic HCV infection with advanced liver~     disease and have never been treated for HCV~      Design:~      Participants will be screened with a physical exam and medical history. Blood samples will be~     collected. A liver biopsy may also be performed.~      Some participants will take the two study drugs and some will take three study drugs. Those~     who take GS-7977 and GS-5885 will have one daily tablet named fixed dose combination or FDC.~     Those who take GS-7977 and CS-9669 will have three daily tablets taken once daily. Those who~     take GS-7977 and GS-5885 and GS-9451 will take 2 pills once a day. GS-7977 and GS-5885 will~     be combined in one pill and GS-9451 will be in another pill.~      Treatment will be monitored with frequent blood tests. These tests will check liver function~     and the level of HCV infection. Participants may have other blood tests as needed for~     treatment.~      Participants will have 4, 6 or 12 weeks of treatment depending on which study drugs are~     scheduled to take. After they complete their schedule, they will stop treatment with the~     study drugs. They may also have another liver biopsy.~      Participants will have regular follow-up visits over the next 48 weeks. They will have~     physical exams and provide blood samples....~   "
134572|NCT01805869|"~     Background:~      - The third molars (wisdom teeth) normally grow in during late adolescence or early~     adulthood. Many people need or choose to have these teeth removed with oral surgery.~     Normally, the removed teeth and tissue are thrown away as medical waste. However, oral health~     researchers want to collect the teeth and tissue for research. They also want to encourage~     dentists at the National Institutes of Health to improve their skills in oral surgery. This~     study will collect the teeth and tissue of people who need to have oral surgery to remove~     their wisdom teeth.~      Objectives:~        -  To provide continued dental skills training for dentists at the National Institutes of~          Health.~        -  To collect teeth and tissue samples following wisdom tooth removal surgery.~      Eligibility:~      - Individuals between 16 and 50 who need to have their wisdom teeth removed.~      Design:~        -  This study will involve a minimum of three visits. There will be a screening visit, a~          surgery visit, and at least one follow-up visit.~        -  Participants will be screened with a physical exam and medical history. A full dental~          exam with x-rays will be given to evaluate the need for surgery.~        -  At the second visit, participants will have oral surgery to remove their wisdom teeth.~          The teeth and tissue removed during the surgery will be collected for study.~        -  Participants will receive drugs to control the pain after surgery. They will also be~          able to contact a dentist if there are any problems.~        -  Between 7 and 21 days after surgery, participants will have a followup visit to check~          the healing. If they are having no problems, this will be the last visit. If there are~          any postsurgery issues, they will be scheduled for additional visits as needed.~   "
134573|NCT01805856|"~     The effectiveness of antimicrobial prophylaxis (AMP) for prevention of surgical site~     infection (SSI) following thyroid and parathyroid surgery remains uncertain. Present~     prospective randomized control study (Ito-RCT1) assessed the effectiveness of AMP in clean~     neck surgery associated with thyroid and parathyroid disease.~   "
134574|NCT01805843|"~     Chronic myelogenous leukemia (CML) is a chronic myeloproliferative disorder characterized by~     a translocation between chromosome 9 and 22, leading to a pathogenic tyrosine kinase signal~     transduction protein. CML can be treated with tyrosine kinase inhibitors (TKIs), which~     inhibit BCR/ABL kinase, such as imatinib. In about 20% of CML patients who are treated by~     imatinib, a complete cytogenetic response cannot be achieved. The other two novel TKIs~     (dasatinib and nilotinib), achieve higher rates of complete cytogenetic response and they are~     proposed as second-line therapy for imatinib-resistant patients or for those who do not~     tolerate imatinib. Dasatinib inhibits BCR/ABL kinase in about >300 times in vitro in more~     than imatinib and also inhibits several other kinases, including the Src family. Src tyrosine~     kinase is crucial for potassium channel function in human pulmonary arteries. Imatinib and~     nilotinib do not inhibit the Src.~      Incident cases of precapillary PH have been reported in patients who have CML treated with~     the dasatinib. Improvements were usually observed after withdrawal of dasatinib.~      This study is designed to identify incident cases of dasatinib-associated PH and describe~     pulmonary vascular changes induced by dasatinib. As comparison population will be patients~     who receive another second-line TKI (nilotinib).~   "
134575|NCT01805830|"~     The study design of this trial is double blind, parallel-group, randomized, Placebo~     controlled study.~   "
134576|NCT01805817|"~     Oral combined contraceptives(OC) have both progesterone and estrogen inside.~     Levonorgestrel-releasing intrauterine device(LNG_IUS) has only progestagen.~      Copper IUD does not have any hormonal molecule inside.~        -  Hypothesis is OC has more systemic beneficial or side effects than LNG_IUS or copper~          IUD. LNG_IUS has more local effects than copper IUD.~        -  Study reflects the beneficial or side effects of estrogen+progestagen pills and only~          progestogen inside device.~   "
134905|NCT01801514|"~     The purpose of the study is to evaluate the feasibility of multilayer detection-based dual~     energy computed tomography scanner and to assess the added diagnostic value of dual energy~     applications~   "
134906|NCT01801501|"~     The purpose of the study is to evaluate the potential role of plasmatic Fibroblast Growth~     Factor 23 (FGF-23) as a prognosis predictor of clinical outcomes in Critical Care patients.~   "
134578|NCT01805791|"~     A placebo controlled study of two doses of HMPL-004 in patients with active mild to moderate~     ulcerative colitis (UC), with a modified Mayo Score 4-10 and an endoscopy subscore of 2-3,~     taking mesalamine (or equivalent) as a concomitant medication.~      The objective is to evaluate the efficacy and safety of HMPL-004 with mesalamine (mesalamine~     treatment failures). Efficacy will be measured by a comparison of the proportion of patients~     in each treatment group attaining clinical remission at Week 8 as compared to placebo.~   "
134579|NCT01805778|"~     Cancer therapy can place childhood cancer survivors at increased risk for heart disease which~     can lead to significant illness or early death. Interventions that occur late in the~     evolution of treatment-related heart disease are usually ineffective at preventing its~     progression to death or heart transplant. Our team will work in several research cores to~     test new imaging and biomarker methods that will lead to earlier detection of heart disease~     before clinical symptoms develop or it become apparent on standard imaging tests. We will~     evaluate the importance of genetic differences between individuals in determining who is at~     greatest risk of developing heart disease as a result of exposure to cardiotoxic agents. We~     will combine this genetic information with the novel imaging and biomarker methods to predict~     which children are at particular risk. These vulnerable children can then be targeted by~     modifying their cancer therapy to reduce their exposure to cardiac toxins, or introducing~     medications that protect the heart from chemotherapy damage. This team brings together the~     expertise of clinicians and scientists in pediatric oncology, pediatric and adult cardiology,~     radiation oncology, genetics, and biostatistics. This is a cross-Canada initiative that will~     leverage the latest knowledge about cardiac toxicity and create a resource for ongoing~     research into this important cause of morbidity and mortality in childhood cancer survivors.~   "
134580|NCT01805765|"~     The objective of this study is to evaluate whether a Chinese medicine formula (Qing'E) is~     effective in alleviating menopausal symptoms and safety.~   "
134581|NCT01805752|"~     Each year, an estimated 230,000 HIV-infected women in need of services for prevention of~     mother-to-child transmission of HIV (PMTCT) give birth in Nigeria, more than in any other~     nation in the world. Vanderbilt University (VU), through its affiliate, Friends in Global~     Health (FGH), is currently supporting HIV/AIDS services in North-Central Nigeria. These sites~     are predominantly rural primary health centers (PHCs) where shortages of high-cadre health~     care providers and insufficient laboratory capacity to perform CD4+ cell count testing have~     been major barriers to effective PMTCT scale-up. A systematic reassignment of patient care~     responsibilities coupled with the adoption of point-of-care (POC) CD4+ cell count testing~     will facilitate the ability of lower-cadre health providers to manage PMTCT care, including~     the provision and scale-up of antiretroviral treatment (ART) to pregnant women in these~     rural, decentralized sites. A system wherein men are facilitated to accompany their wives to~     ANC appointments will create an important opportunity to address entrenched gender norms. The~     investigators therefore propose using community and facility-based measures to encourage male~     partners to accompany their spouses for ANC. As influential community members, male partners~     can assist their spouses to utilize culturally-sensitive, sustainable and integrated PMTCT~     care provided by lower-cadre providers in these resource-constrained settings.~      The investigators propose a parallel, cluster randomized trial to evaluate the impact of a~     family-focused PMTCT package that includes: 1) task-shifting to lower-cadre providers at~     PMTCT sites; 2) POC CD4+ cell count testing; (3) integrated mother-infant care; and (4)) a~     prominent role for influential family members (male partners), working in close partnership~     with community-based health workers/volunteers. The specific aims of this study are:~        1. To evaluate whether implementation of the integrated PMTCT package in primary level~          antenatal clinics (ANC) increases the proportion of eligible pregnant women who initiate~          antiretroviral medications for the purposes of PMTCT. The investigators hypothesize that~          the provision of the PMTCT package in intervention clinics will improve PMTCT~          antiretroviral uptake rates among eligible women during pregnancy from 40% to 65%.~        2. To determine whether implementation of the PMTCT package improves postpartum retention~          of mother-infant pairs at 6 and 12 weeks. The investigators hypothesize that postpartum~          retention rates among mother-infant pairs attending intervention sites will be >20%~          higher at 6 weeks when compared to mother-infant pairs receiving care in~          non-intervention sites.~        3. Conduct a cost-effectiveness analysis (CEA) of the impact of this novel PMTCT~          intervention compared to the existing standard-of-care referral model. The investigators~          hypothesize that the proposed intervention will be more cost-effective than the existing~          model of care.~      In addition, two qualitative evaluations will be conducted in order to:~        1. Assess client satisfaction with health services, comparing PMTCT services provided by~          lower level vs. higher level cadre health workers; and~        2. Evaluate health care worker satisfaction with the new PMTCT service delivery model.~   "
134582|NCT01805739|"~     Transcatheter aortic valve implantation (TAVI) is an emerging alternative therapy for aortic~     stenosis for patients ineligible for open heart surgery or at high risk for perioperative~     complications. Pre-procedural imaging of the aortic root is essential for selection of the~     correct valve prosthesis and to minimize complications as prosthesis mismatch, possibly~     subsequent embolization, coronary obstruction, annulus rupture or severe aortic~     regurgitation.~      The aim of the study is to compare the different imaging modalities for aortic root~     measurements.~      Aortic root imaging will be performed prior to TAVI-procedure. The contrast injection will be~     performed either into the aorta or into the left ventricle. The datasets will be assessed by~     blinded-independent observers in a multi-planar reconstruction view.~      The study will be performed retrospectively (2009-2012) and prospectively starting 2013.~   "
134583|NCT01805726|"~     The purpose of this study is to find the best sedation necessary for patients undergoing~     bronchoscopy. Patients are randomized to three different regimes of sedation during~     bronchoscopy were studied:~        1. - Group standard/control: local anesthesia only(C)~        2. - Group alfentanil + local anesthesia(A)~        3. - Group dexmedetomidine + local anesthesia(D) The primary endpoint is the bronchoscopy~          score. Secondary endpoints are: Level of sedation and tolerance bronchoscopy~          examination. Measured parameters on the safety of examination are: the lowest~          saturation, needs to supplemental oxygen, amnesia , choking sensation or chest pain and~          if the patient is ready or not to undertake bronchoscopy second time in his life if~          necessary. Endtidal CO2, Respiratory rate, Blood pressure, Heart rate, level of oxygen~          are collected every 5 minutes before, during and after the bronchoscopy.~   "
134584|NCT01805713|"~     Cystic fibrosis (CF) is the most common autosomal recessive genetic disease in Caucasians. It~     results in lung disease that affects quality of life and causes early death. Lung damage from~     CF starts in infancy and continues over time. Lung damage can negatively affect how the lung~     functions. It would be ideal to measure lung damage in CF patients in three instances: (1)~     During the first year of life after diagnosis by state newborn screening programs, (2) In~     children and adults over long periods of time (years), and (3) During times of illness~     (pulmonary exacerbation), to allow for better treatment and therapy to prevent loss of lung~     function. The lung is made of elastin, collagen and cartilage. When the lung is damaged by~     CF, these components break down into pieces that can be measured in urine, sputum and blood.~     These products may represent markers of lung injury. We believe that the levels of these~     markers will be increased over time in CF patients and even higher in patients who are sick~     with lung symptoms. The goal of my research is to measure the amount of lung breakdown~     products in urine, sputum and blood in infants, children and adults with CF during times when~     well and also during times of illness. I also hope to use new technologies involving the~     study of proteins and metabolites in samples like sputum, urine and blood to help provide new~     information regarding CF lung disease. These studies will help us to better treat CF lung~     disease.~   "
134585|NCT01805700|"~     The aim of this pilot study is to determine the impact of caffeine-enhanced energy drinks on~     blood glucose excursion on heart rate, blood pressure, cardiac output and cognitive~     performance in patients with type 1 diabetes.~      Knowledge acquired may inform a wider study of the impact of these drinks.~      This is a randomised, cross over blinded study in which all participants will participate in~     the 3 arms of the study.~      The study will consist of 3 phases, each lasting 3 days. A different study drink will be~     administered during each phase. There will be an initial screening visit and a pre- study~     visit before each study phase. Each participant will make 10 visits to the research centre.~      There will be a week wash out period between each study phase. Prior to each study phase,~     there will be a 3 day caffeine and alcohol abstinence run-in period.~      Study drinks will be matched for taste and volume (as far as possible) and will be~     administered by the use of opaque cups, lids and straws to enable double-blind randomisation~     for both researcher and participants. Administration of the study drink to participants will~     be based on Latin squares to provide a balanced treatment order.~      During the 3 days study period; participants will be required to abstain from all other~     caffeine containing beverages or confectioneries.~      The secondary aim is to determine if tolerance to cardiovascular effects of caffeine-enhanced~     energy drinks is developed following acute short term ingestion.~   "
134586|NCT01805687|"~     Study to evaluate the bronchodilator effects of Zyflo CR in patients with chronic stable~     asthma.~   "
134587|NCT01805674|"~     In menopause, the vasomotor symptomatology, accompanied or less by affective and behavioural~     symptoms, globally worsens the quality of daily life.~      The improvement of the quality could be reached with adequate food supplements, named~     phytoestrogens, in particular Soy Isoflavones (SI), which are natural substances with~     estrogen-like and estrogen-antagonistic activity, which are active in the control of~     menopausal vasomotor symptoms. Besides, combined with magnolia extract it could improve the~     psychological symptomatology also improving the quality of life.~   "
134588|NCT01805661|"~     To compare early ambulation and ability to participate in rehabilitation in patients~     undergoing total knee replacement using two different nerve block techniques for pain~     control. The 2 methods are 1) Adductor canal block with posterior capsular injection 2)~     femoral nerve block with tibial nerve block~   "
134589|NCT01805648|"~     The purpose of this study is to evaluate the efficacy and safety of rhTPO in the maintenance~     treatment of ITP, to explore the appropriate dosing interval of the maintenance treatment of~     rhTPO .~   "
134590|NCT01805635|"~     The aim of this study is to assess the influence of kind of allergic disease, allergic~     profile, allergen exposure, treatment method on lung function parameters, fractional exhaled~     nitric oxide level in children suspected and being diagnosed due to allergic diseases.~   "
134591|NCT01805622|"~     -  Hypothesis 1. When compared to passive dissemination, active dissemination will result~          in greater participant enrollment.~        -  Hypothesis 2. The intervention will be offered with equal fidelity in churches, clinics~          and community sites.~        -  Hypothesis 3. Knowledge of CRC screening and perceived risk of CRC will be positively~          correlated.~   "
134592|NCT01805609|"~     The purpose of this study is to provide a communication training program to inpatient nurses~     and social workers at Memorial Sloan Kettering Cancer Center in order to help them assist~     caregiving families. The importance of this training program is that it aims to teach nurses~     and social workers how and when to respond more effectively and compassionately to challenges~     faced by caregiving families. One of the goals of this program is to address family support~     needs during a patient's hospitalization.~   "
134593|NCT01805596|"~     This study is to assess the function of blood vessels while being treated with different~     types of blood thinners to determine the effect of these medications on blood vessels.~   "
134594|NCT01805583|"~     Evidence-based clinical treatments for common mental disorders, such as CBT and/or~     pharmacotherapy, have resulted in significant and sustained improvement in clinical symptoms.~     However, the individual-focused treatments rarely have sickness absence as a target of~     intervention or evaluate work-related outcomes, such as return to work. A recent review of~     the evidence for managing stress at work showed that individual interventions give effects on~     mental health measures but did not impact absenteeism at work. The purpose of this study is~     to examine the efficacy and cost-effectiveness of two different rehabilitation models, one~     based on psychotherapy and the other on workplace-interventions, when these are offered as~     standalone interventions and in combination for patients with adjustment, anxiety and~     depressive disorders.~   "
134595|NCT01805570|"~     The aim of the RAPID study is to evaluate the superiority rapid onset of action of Ticagrelor~     360 mg LD versus Prasugrel 60 mg LD, in 50 patients with STEMI (ST segment elevation~     myocardial infarction) undergoing PPCI with bivalirudin monotherapy. Secondary study aim is~     to found out clinical predictors of high residual platelet reactivity in the first hour after~     a novel oral antiplatelet agent LD.~   "
134596|NCT01805557|"~     The probability to achieve CR with R-chemotherapy in patients failing a rituximab containing~     first line regimen is quite low, in particular in cases with non GCB profile. The bioCORAL~     trial suggest that ABC subset have a dismal outcome whichever the induction treatment. Thus~     it can be argued the addition of new molecule to the RDHAP regimen could be of value.~     Bortezomib appears the best candidate in this setting as ABC subtypes constitutively express~     NFkb, which is the target of bortezomib itself. Data from the literature suggest an~     encouraging activity of R-chemo+ bortezomib in non GCB-derived DLBCL, although in small~     series. Thus, the addition of bortezomib is here justified by the need to circumvent~     constitutional resistance to chemotherapy. Published experience of the association between~     bortezomib and cytarabine are also encouraging with acceptable cumulative toxicity.~   "
134597|NCT01805544|"~     National, multicenter, prospective, observational, non-interventional study. The objective is~     to determine if the switch from Vitamin K antagonists (VKA) to Xarelto in subjects treated~     with VKA with issues in deep venous thrombosis (DVT), and prevention of recurrent DVT and~     pulmonary embolism (PE) is associated with an improvement of the treatment satisfaction after~     3 months. The treatment satisfaction will be measured by the Anti Clot Treatment Scale (ACTS)~     score.~   "
134598|NCT01805531|"~     National, multicenter, prospective, observational, non-interventional study. The objective is~     to determine if the switch from Vitamin K antagonists (VKA) to Xarelto in subjects treated~     with VKA with issues for stroke prevention in non valvular atrial fibrillation is associated~     with an improvement of the treatment satisfaction after 3 months. The treatment satisfaction~     will be measured by the Anti Clot Treatment Scale (ACTS) score.~   "
134610|NCT01805375|"~     The main aims of this clinical study are to find out the maximum dose that can be given~     safely to patients, the potential side effects of the drug and how they can be managed. The~     study will also look at what happens to Anti-CD19 (DI-B4) inside the body.~      DI-B4 is a type of drug called an Anti-CD19 monoclonal antibody which is being used to stop~     the growth and kill cancerous immune cells by targeting the B-cell marker (CD-19) expressed~     on their surface. This drug has not been given to patients before.~      DI-B4 will be given weekly by intravenous infusion for four weeks. The study is in two parts.~     In Part 1, small groups of patients will be treated at increasing doses to find the highest~     safest dose and best dose for part 2 of the study. Approximately 16-20 patients will be~     treated in this part. In Part 2, the dose identified in Part 1 will be given to approximately~     20 patients.~      Patients recruited to the study will receive four weeks (cycles) of treatment. They will~     attend an end of therapy visit eight weeks after their last dose of DI-B4, and attend~     follow-up visits up to eighteen months after their first dose of DI-B4. Information on the~     overall and progression free survival will be collected for a period up to eighteen months~     after the final patient is treated on the study.~      Patients will have blood and urine samples taken each week during treatment amongst other~     clinical tests. CT scans will be performed at the start of the study, at eight weeks post~     treatment and six months after the study start. Bone marrow biopsies and FDG-PET scans will~     only be taken if needed. Research blood samples will also be taken to look at what happens to~     the drug inside the body.~      It is important to explain that patients will have advanced cancer so it is unlikely that~     patients will benefit directly from taking part but the study may help improve future~     treatment of cancer.~   "
134907|NCT01801488|"~     Test single nucleotide polymorphisms (SNP's) in ruptured and unruptured aneurysm tissue to~     identify a genetic difference between the two types of aneurysms; and to test SNP's in~     arteriovenous malformation tissue to identify a genetic link.~   "
134599|NCT01805518|"~     Phosphodiesterase is a candidate for the Rx & prevention of cognitive and psychotic~     disorders. Since caffeine targets primarily PDE4(Phosphodiesterase subtype 4), caffeine~     analogs have been developed to mimic the actions of caffeine's ability to inhibit PDE-a,~     PDE4, PDE5 and adenosine-2 (AD-2)but are limited by the side effects of insomnia and~     heightened anxiety. Sildenafil (PDE-5 inhibitor) fails to enhance cognition in schizophrenia.~      The study of PDE-4 in cognition in Alzheimer's dementia and schizophrenia has been done using~     the PDE-4 prototypal compound, rolipram, which improves cognition in rodents. Rolipram~     reverses the memory deficits induced by amyloid fragment Abeta25-35 and Abeta1-40 peptide. In~     humans the frequent side effect of vomiting hampers translational research. The clinical~     trial of rolipram in multiple sclerosis was terminated prematurely due to serious adverse~     events with paradoxical increases in MRI MS-specific brain lesions. However, PDE-4 remains~     paradigm for cognition.~      Another strategy is chemical moieties capable of antagonizing the PDE-4 through allosteric~     modulation, rather than direct competitive inhibition hoping to minimize adverse events while~     retaining the biological potencies and functional responses of PDE-4 Modulators. Dietary~     supplements with PDE-4 effects have advantages in that small investments are needed to~     adequately study them.~      Pharmacologically active chemicals of Sceletium species are mesembrine-type alkaloids that~     have proven PDE-4 activity. The PDE-4D knockout mice have enhanced memory function mediated~     through hippocampal neurogenesis via phosphorylated cAMP response element binding protein~     (pCREB) signaling.~      This study purpose is to delineate the relationship of PDE-4 and cognition in normals. pCREB~     is possibly the putative biomarker of PDE-4 response with CREB as effector signaling pathway~     of PDE-4. CREB is close to nuclear receptors represented by BDNF (Brain Derived Neurotrophic~     Factor) and PPAR (Peroxisome Proliferator Activating Receptor) complexes. CREB changes in~     neuronal plasticity are targets for pharmacological paradigms for cognitive enhancement. This~     study will use the scelectium tortuosum as manufactured as Zembrin®. The findings in control~     subjects will form the basis for designing future studies of Zembrin® in neurodegenerative~     disorders with marked cognitive impairment such as Alzheimer's Dementia and Parkinson's~     Disease.~   "
134600|NCT01805505|"~     Transabdominal ultrasound guidance is the golden standard for embryo transfers. Transvaginal~     ultrasound guidance was proposed recently to provide better visualization and reduce patient~     discomfort as embryo transfer can be performed with an empty bladder in this case. The~     purpose of this study is to determine whether there are any differences between transvaginal~     and transabdominal ultrasound-guided embryo transfer in terms of ease of use, patient~     satisfaction, and treatment outcome.~   "
134601|NCT01805492|"~     The purpose of this study is to characterize changes in gene and protein expression in~     peripheral blood in patients with, or at risk for, heart disease during an intensive~     lifestyle modification program.~   "
134602|NCT01805479|"~     The purpose of this study is to determine the feasibility of successfully delivering moderate~     intensity aerobic exercise training to depressed traumatic brain injury subjects between one~     and three years after injury.~   "
134603|NCT01805466|"~     The primary purpose of this study is to assess the effects of the use of EVADO with respect~     to a conventional cardio-pulmonary bypass (CBP) system on surgical morbidity and mortality.~     As secondary aim this study wants to conduct appropriate laboratory investigations in order~     to detect the major biological mechanisms potentially responsible for the beneficial effects~     of the EVADO system on the coagulation cascade and inflammatory activation.~   "
134604|NCT01805453|"~     To assess the efficacy of an Angiotensin-II inhibitor (Losartan) to reduce peritumoral edema~     in newly diagnosed glioblastoma patients.~   "
134605|NCT01805440|"~     This is a randomized, double-blind, placebo-controlled study of the investigational drug~     uridine as a treatment for depressed adolescents with bipolar disorder (i.e. bipolar~     depression). Participants initially randomized to placebo who complete the 6-week protocol~     will be offered 6 months of open-label uridine treatment and follow-up. Participants~     initially randomized to uridine will be offered the open-label treatment as well.~   "
134606|NCT01805427|"~     The concentration of the third agent in antiretroviral therapy [Non Nucleoside Reverse~     Transcriptase Inhibitor (NNRTI), or boosted Protease inhibitor (PI) ] is different according~     to the body weight or body composition and therapeutic monitoring may be necessary in~     overweight HIV patients.~      The investigators aim at measuring the individual trough concentrations of interest [at~     steady state for NNRTI and boosted PI] in overweight and normal weight HIV+ patients.~   "
134607|NCT01805414|"~     A standard hospital meal often contains a high percentage of carbohydrates (CHO), which may~     not be ideal for patients with diabetes. This concern is particularly pertinent to the~     breakfast meal, which often contains mainly CHO. Clinical observations suggested that such~     diets elevate pre-lunch blood glucose (BG) values. The study team compared standard hospital~     no concentrated sweets (NCS) breakfast meals with more balanced meals. The study team~     hypothesized that a balanced breakfast would improve pre-lunch BG values.~      This 8-week pilot study was conducted at Duke Hospital on two non-ICU cardiology wards. Ward~     A consisted mainly of patients with a primary diagnosis of coronary artery disease (CAD).~     Ward B consisted mainly of patients with a primary diagnosis of congestive heart failure~     (CHF). The intervention breakfast menu included 5 choices containing 40-45g of CHO. All~     patients on Ward A (with and without diabetes) were given the intervention breakfast for the~     first 4 weeks of the study, while those on Ward B received standard menus (60-75g CHO in NCS~     meals). After 4 weeks, the standard and intervention wards were switched. Data were collected~     only on patients with diabetes who were able to consume meals.~   "
134608|NCT01805401|"~     In this study the investigators aim to assess whether transcranial direct current stimulation~     (tDCS; a safe and non-invasive method for modulating the activity of specific brain regions)~     when applied over the orbitofrontal cortex (OFC) is able to modulate decision-making and~     impulse control in healthy participants.~   "
134609|NCT01805388|"~     The purpose of our study is to characterize the composition of the hard and soft tissues~     present after regenerative endodontic procedures in root canals of teeth previously diagnosed~     with the need for extraction for orthodontic treatment and incomplete root formation.~     Although the protocol addressed in this study is currently being used in clinical practice,~     there are no prospective clinical trials investigating its efficacy in stimulating continued~     root development and the nature of the newly formed tissues.~   "
134631|NCT01805102|"~     PIF: biomarker of pregnancy, miscarriage, premature birth, preeclampsia, placenta accreta.~      Except for serum hCG, no pregnancy-complication markers are widely employed to predict the~     need for medical intervention. Since circulating PIF is present from very early and~     throughout viable pregnancy, it may represent a specific biomarker candidate. PIF levels will~     be analyzed in serum of pregnant women in a range of settings: a) following IVF; b) index~     pregnancy of women with history of recurrent pregnancy loss, c) index pregnancy of women with~     history of placenta mediated complications such as: intrauterine growth restriction,~     spontaneous idiopathic preterm delivery, and preeclampsia; and d) index pregnancy in women~     with evidence of abnormal placentation, namely placenta accreta and related conditions.~   "
134611|NCT01805362|"~     Objective:~      To show that the frequency of aldosterone breakthrough is lower when RAS blockers are given~     at bedtime compared to on awaking, and to analyze the determinants and consequences of~     aldosterone breakthrough.~      Duration of the study: Inclusion 2 years, follow-up one year, total 3 years Design:~     prospective, multicenter, randomized, controlled, open label, two parallel groups.~      Main selection criteria:~      Inclusion criteria~        -  Chronic kidney disease stage 3 to 4,~        -  ACEI (captopril, enalapril, or ramipril), and/or ARB (losartan, valsartan, or~          irbesartan) on awaking for at least three months,~        -  History of hypertension or proteinuria > 0,5 g/24h or g/g créatininurie.~      Exclusion criteria~        -  Office blood pressure ≥ 160/100 mmHg,~        -  Anti-aldosterone (spironolactone, eplerenone) or potassium sparing diuretics (modamide,~          amiloride), or direct renin inhibitor.~      Evaluation criteria:~      Primary: Serum aldosterone levels at one year.~      Secondary:~        -  Serum aldosterone/renin ratio,~        -  24h urine aldosterone,~        -  Significant aldosterone breakthrough defined by a >10% increase of serum aldosterone~          levels over baseline values,~        -  Aldosterone breakthrough defined by an increase of serum aldosterone levels over~          baseline values,~        -  HbA1c,~        -  Urinary albumin/creatinine ratio (UACR) on spot morning urine samples,~        -  Systolic home blood pressure (SBP),~        -  Estimated glomerular filtration rate (eGFR) using the MDRD equation.~   "
134612|NCT01805349|"~     Among the risk factors for lower limb osteoarthritis, if obesity is probably the most~     studied, digital osteoarthritis received increasing interest in recent years. Recent~     publications have highlighted a link between obesity and digital osteoarthritis, but also a~     very probable link between digital osteoarthritis and structural progression of knee~     osteoarthritis. Few data including hip exist and need to be confirmed on larger scale~     studies. We have with Khoala a national multiregional cohort of symptomatic gonarthrosis~     and coxarthrosis representative of the general population (which is rarely the case in the~     literature) including X ray, clinical and biological follow-up (hips and / or knees).~   "
134613|NCT01805336|"~     Since many years cognitive disorders are a main topic of clinical research in Multiple~     Sclerosis (MS) as there could be observed early on in the disease and could induce with time~     in patients significant socio-professional burden. Today assessment of cognitive dysfunction~     in MS is still based on traditional pencil-paper task tests which are not able to give a true~     representation of functional burden observed in patients in real life situations. The~     development of new tools close to these life situations, i.e. more ecological, are needed~     to better assess and take in charge cognitive impairment in MS patients. One way to reach~     this goal is Virtual Reality (VR). VR offers a new human-computer interface paradigm that~     simulates a realistic 3D environment where the user become immersed and interacts with it.~     These last ten years VR has known a rapid development in the health domain and has been~     applied with success to motor rehabilitation, psychiatry and neuropsychology. In this last~     domain, virtual environment (VE) reproducing activities of daily living have been used to~     evaluate executive and memory functions as well as attentional or visuospatial processes.~     Among main VE developed, driving assessment system, navigation skills, cooking behaviors,~     virtual supermarket have shown better sensitivity to detect functional consequences of~     cognitive impairment in various neurological and psychiatric disorders than traditional~     evaluations. In Caen University Hospital, investigators used VE driving system and developed~     the use of the Virtual Action Planning in a supermarket (VAP-S ; Klinger et al 2004) where a~     user move to select and buy groceries and other things inside an interactive virtual~     supermarket using a shopping cart. In a preliminary study investigators have used this~     virtual interactive tool to evaluate executive functioning in small group of Parkinson's~     disease and MS patients. Analysis of initial data shows the feasibility of the VAP-S for use~     with these two kinds of diseases. According to these results investigators planned a new~     study in Relapsing-Remitting(RR)- MS patients where they compare the use of VE (driving~     system and the VAP-S) to traditional attentional and executive evaluation for estimate their~     respective sensitivity to detect cognitive/functional impairment in MS patients.~     Investigators hope to shown that VR will demonstrate its interest to assess cognitive~     functions in MS and to develop cognitive rehabilitation.~   "
134614|NCT01805323|"~     This retrospective chart review study will describe the history of patients with retinal~     disease with macular edema to whom OZURDEX® (dexamethasone intravitreal implant) is~     administered, and assess treatment patterns and visual outcomes. OZURDEX® was previously~     administered according to general clinical practice.~   "
134615|NCT01805310|"~     Prior to surgery, gynecologists and urogynecologists have routinely prescribed preoperative~     mechanical bowel preparations in attempts to decrease the risk of infection, while also~     providing easier bowel manipulation and better visualization during surgery. However, many of~     these proposed benefits have never been proven, and usage of bowel preparations amongst~     surgeons remains highly variable. In both the general surgery and gynecology literature,~     researchers have begun to question the need for the vigorous preparations.~      Aside from surgical visualization, urogynecologists have additional concerns about how bowel~     preparations may impact postoperative bowel function given up to half of women with pelvic~     floor disorders have baseline constipation and straining is known to impact surgical~     recovery. Many studies have addressed various postoperative fiber and laxative preparations~     in attempts to improve postoperative bowel-related symptomatology, but none have specifically~     looked at preoperative bowel preparations.~      This study aims to determine if mechanical bowel preparation prior to minimally invasive~     sacral colpopexy affects patients' postoperative recovery, specifically related to bowel~     symptomatology; operative or post-operative complications; surgeons' perceptions of surgical~     difficulty directly attributed to the bowel; and post-operative return of normal bowel~     function.~   "
134616|NCT01805297|"~     To evaluate the ocular and systemic safety of intravitreal aflibercept injection in patients~     undergoing Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy.~   "
134617|NCT01805284|"~     The objectives of the study are:~      (i) to evaluate the proportion of patients who attain a T>MIC (Minimum Inhibitory~     Concentration) of 100% and the time frame in which they do so. The investigators therefore~     plan to measure unbound linezolid trough concentrations before administration of the second,~     third, fourth and fifth dose. Furthermore, the investigators will assess the AUC0 - 24h/MIC~     in all study subjects. Therefore, multiple plasma samples will be drawn after the fourth or~     fifth dose, when steady state conditions are reached.~      (ii) to describe the pharmacokinetic variability of unbound linezolid concentrations in this~     cohort using a population pharmacokinetic model and to assess the expected probability of~     target attainment (PTA) by MIC against MRSA.~      Twenty adult, MRSA-positive, morbidly obese patients with clinically and radiologically~     documented pneumonia are to be included. Therefore, a multi-centre, international~     observational study is necessary. Given the specific target population this study is not~     feasible in a single-centre approach. The goal is to find up to 6 centres that anticipate~     including 3 to 4 patients in the study within a time frame of one year.~      Included patients should receive at least 6 doses of linezolid. Linezolid must be~     administered intravenously (iv) over a one hour controlled infusion (with use of a volumetric~     infusion pump).~   "
134618|NCT01805271|"~     A significant number of patients relapse and eventually die, particularly if they were~     initially diagnosed with large nodes involvement and/or T3/4 diseases. When analyses focus on~     patients with ER+/Her2-negative breast cancer, with ≥4N+, 30% had relapsed at 5 years,~     emphasizing the need for new drugs in this setting (PACS01 data, UNICANCER internal data).~      Strong evidence suggests that cross-talk between the phosphatidylinositol 3-kinase~     (PI3K)/AKT/mammalian target of rapamycin (mTOR) pathway and ER signaling is linked to hormone~     resistance in breast cancer patients.~      In the present study, we plan to evaluate the benefit from adding everolimus to standard~     endocrine treatments after three years of treatment for patient ER+/HER2- at high risk of~     relapse due to high nodes involvement (≥4) and/or persistent node involvement after~     neo-adjuvant chemotherapy.~      Genomic signatures have emerged during the last 10 years as a new and additive means to~     evaluate more precisely long term prognosis, and in some instances the amount of benefit from~     chemotherapy or endocrine therapy in the adjuvant setting. Therefore the UNIRAD study can be~     proposed to patients with 1-3 positive lymph nodes at primary surgery and a high risk of~     relapse with the EndoPredict test.~      This study is a unique opportunity to prove the efficacy of everolimus in adjuvant setting.~     The study could be practice changing in case of positive results and could allow improving~     outcome of breast cancer patients presenting high risk of metastatic relapse.~   "
134619|NCT01805258|"~     The purpose of the study is to evaluate the efficacy and safety of Nevarapine and Rifampicin~     vs Efavirenz and Rifampicin in antiretroviral naive patients co-infected with HIV and TB and~     to investigate whether Rifampicin co-administration in clinical practice leads to a~     clinically relevant decrease of Nevirapine plasma concentrations in Indian patients~     co-infected with HIV and Tuberculosis and to characterize drug-associated toxicities~     (especially hepatic).~   "
134620|NCT01805245|"~     The purpose of this study is to evaluate the impact of stress reduction on physiological and~     psychological variables in adults with Type 2 diabetes (T2DM) who have moderate to severe~     levels of diabetes-related emotional distress. Subjects will be randomized to one of two~     interventions. We will evaluate the impact of the interventions on glucose metabolism, blood~     pressure, diabetes-related distress and quality of life. Additionally, we will investigate~     the role of neuroendocrine dysfunction, systemic inflammation and diabetes self-care~     practices as mediators in the relationship between increased stress, adverse glucose~     metabolism and elevated blood pressure in those subjects with T2DM.~   "
134621|NCT01805232|"~     Intravenous artesunate is egual to quinine in the treatment of severe malaria~   "
134622|NCT01805219|"~     The aim of the study is to validate the association of the GPS and accelerometer tools in~     order to assess the humain locomotion during exercises.~      The hypotheses are:~        1. GPS and accelerometer together can assess the human locomotion~        2. GPS and accelerometer together can assess the energy expenditure during exercises~   "
134623|NCT01805206|"~     During the first four days of life, intestinal fatty acid binding protein (iFABP) is elevated~     in the urine of premature babies who go on to develop necrotizing enterocolitis (NEC) days to~     weeks later. This study aims to determine whether the withholding of feedings in babies with~     an elevated urinary iFABP can reduce the incidence of NEC.~   "
134624|NCT01805193|"~     Coronary heart disease is a very common condition caused by narrowings in the blood vessel~     supplying the heart. the investigators are studying new tests to diagnose heart disease. In~     this study the investigators plan to investigate a special scan called a PET/CT (Positron~     emission tomography/computed tomography) and a new type of CT (Computed tomography) scan to~     tell us about the flow of blood to the heart muscle.~   "
134625|NCT01805180|"~     The purpose of this study is to compare the procedures for the collection PMN cells on Terumo~     BCT's Spectra Optia® and COBE® Spectra Apheresis Systems.~   "
134626|NCT01805167|"~     Differences in speech-understanding and the quality of the subjective perception among~     cochlear implant patients (Digisonic SP) depends on numerous factors. The electrical field~     distribution (interaction between electrodes) could also explain the disparity of the~     performances? The objective of our study was to quantify the influence of the electrical~     field interactions between the channels of stimulation according to the vocal performances of~     the implanted subjects, for various subjective levels of electric stimulation.~   "
134627|NCT01805154|"~     The intent of this registry is to understand comprehensive clinical care strategies for~     Cardiac Resynchronization Therapy (CRT) patients especially non-responders in real-world~     clinical practice.~   "
134628|NCT01805141|"~     The investigators hope to learn whether perfusion CT is a useful way to assess primary~     cervical tumor microenvironment and whether there is a relationship between pretreatment~     perfusion CT measurements and primary cervical tumor size, lymph node involvement (as~     assessed by standard of care pretreatment fludeoxyglucose Positron emission tomography/CT~     (FDG-PET/CT)), and treatment response (as assessed by standard of care 3-month post-therapy~     FDG-PET/CT).~   "
134629|NCT01805128|"~     The schizophrenic disorders and pervasive developmental disorders are neurodevelopmental~     disorders distinct origin who share common challenges to engage and maintain social~     relationships and mutual disturbances of affective contact. An important issue of research is~     to determine the cognitive and brain mechanisms underlying social disability in these two~     pathologies. Several lines of social cognition have been systematically explored: the~     perception of emotions, the ability to attribute intentionality and mental states to others~     (theory of mind), the understanding of social situations in different contexts. We made the~     observation today that research findings clearly in the field of autism and schizophrenic~     disorders that converge on common patterns neurocognitive abnormalities. Consequently, many~     programs support published today use the same therapeutic targets and the same tools in both~     pathologies. This raises two questions of science: (1) whether the disorders of social~     cognition reported in the field of autism and schizophrenia are specific deficit and not~     specific condition, that is to say they are inherent social disadvantage whatever condition~     or (2) if these disorders of social cognition is a pattern common to autism and schizophrenia~     but are the result of specific neurocognitive mechanisms and different in each these~     pathologies. Systematic exploration of these issues is a current issue for understanding the~     pathophysiological borders between the two neurodevelopmental disorders but also to better~     define the potential targets of therapeutic strategies, psycho-educational and remediation of~     disorders of social cognition in autism and schizophrenia.~      Main objective: To compare clinical cognitive profiles in adolescents with a schizophrenic~     disorder, autistic or healthy in the three areas of social cognition: perception of emotions,~     attribution of intentions to others (theory of mind) and style attribution. We shall~     constitute three population groups of patients, a group of patients meeting the diagnosis of~     schizophrenia, a group of patients with autism and a control group (healthy subjects).~   "
134630|NCT01805115|"~     The objective of this study is to compare the efficacy of oral, sublingual, vaginal, and no~     misoprostol prior to operative hysteroscopy in premenopausal women.~   "
134928|NCT01801189|"~     Randomized clinical trial to evaluate whether a single pre-operative dose of Pregabalin will~     alleviate post-operative pain and decrease post-operative analgesic requirements in morbidly~     obese patients undergoing laparoscopic gastric bypass surgery.~   "
134632|NCT01805089|"~     The purpose of this research study is to determine whether melatonin taken every night can~     affect blood levels of estrogen or IGF (insulin-growth factor levels). Both IGF and estrogen~     are normally produced in the body and may influence breast cancer risk. Melatonin is also~     naturally produced in the body. Laboratory studies have shown that melatonin may decrease~     cancer growth and influence estrogen and IGF levels. Melatonin's effects on sleep, hot~     flashes, and mood will also be measured.~   "
134633|NCT01805076|"~     The purpose of this study is to test whether patients undergoing a breast MRI (magnetic~     resonance imaging) before breast surgery will have better results after the surgery. Breast~     tumors are routinely evaluated using mammograms and ultrasound before surgery. This study~     would like to find out if using MRI in addition to mammography before surgery improves our~     ability to evaluate tumors and decide what kind of surgery is best for the patient.~   "
134634|NCT01805063|"~     Firefighters are at increased risk of death from heart attacks when compared to other~     emergencyy service professionals whose jobs involve similar components such as emergency~     call-outs and shift work. In the largest analysis of cause of death amongst on-duty~     firefighters, firefighter deaths were classified according to the duty performed during the~     onset of symptoms or immediately prior to any sudden death. The majority of deaths due to a~     cardiovascular cause (i.e. heart attack) occurred during fire suppression whilst this~     activity represented a relatively small amount of a firefighters professional time. There was~     also a risk of death associated with other duties such as emergency non-fire response and~     physical exertion.~      The investigators hypothesize that participation in active fire-fighting duties impairs blood~     vessel function and increases blood clot formation when compared with non-fire-fighting~     activities. In this study, healthy career firefighters will be assessed after three periods~     of duty: fire-suppression, emergency response without fire suppression and following a~     sedentary shift. The investigators will take blood samples to measure platelet activity~     (platelets are the particles in blood that help blood clot) and will examine how blood clots~     outside of the body. The investigators will then perform studies placing small needles in the~     arm to assess blood vessel function following these duties. By undertaking this comprehensive~     assessment of blood, blood vessel and heart function the investigators hope to understand the~     mechanisms whereby the risk of a heart attack, fatal or otherwise, is posed throughout these~     distinct duties that firefighters undertake on a daily basis.~   "
134635|NCT01805050|"~     This study shows a new technique which has been implemented at the schulthess clinic to~     improve the outcome after an correction of an anterior instability in the shoulder joint due~     to a HAGL lesion.~   "
134636|NCT01805037|"~     The purpose of this study is to evaluate how safe and effective the combination of two~     different drugs (brentuximab vedotin and rituximab) is in patients with certain types of~     lymphoma. This study is for patients who have a type of lymphoma that expresses a tumor~     marker called CD30 and/or a type that is associated with the Epstein-Barr virus (EBV-related~     lymphoma) and who have not yet received any treatment for their cancer, except for~     dose-reduction or discontinuation (stoppage) of medications used to prevent rejection of~     transplanted organs (for those patients who have undergone transplantation). This study is~     investigating the combination of brentuximab vedotin and rituximab as a first treatment for~     lymphoma patients~   "
134637|NCT01805024|"~     The purpose of the study is to establish the pharmacokinetic profile of omigapil in~     paediatric and adolescent patients with CMD and to evaluate the safety and tolerability of~     omigapil.~      Funding source - FDA OOPD~   "
134638|NCT01805011|"~     This trial is undertaken to better understand the ranges of functional components normally~     found in human milk. This will strengthen the scientific knowledge on breast-milk composition~     as a gold standard.~   "
134639|NCT01804998|"~     Laparoscopic sentinel lymph node biopsy and stomach preserving surgery in early gastric~     cancer is less invasive method which can increase quality of life. For last two years,~     multicenter quality control study (Phase II) has been performed in Korea and tolerable~     results were observed. Based on these results, multicenter phase III trial is required to~     validate the clinical role of laparoscopic sentinel lymph node biopsy.~   "
134640|NCT01804985|"~     The purpose of this study is to investigate whether some patients with excellent responses to~     chronic myeloid leukaemia (CML) treatment are being overtreated, and can remain well on~     either a lower dose of treatment or without treatment at all. The dose of imatinib (Glivec),~     nilotinib (Tasigna) or dasatinib (Sprycel) treatment will initially be cut to half the~     standard dose for 12 months, and then treatment will be stopped completely for a further two~     years. The trial information will also help to develop a de-escalation and stopping strategy~     for future newly diagnosed CML patients in the next British national CML study (to be known~     as SPIRIT3).~   "
134641|NCT01804972|"~     This study aims to determine the usefulness of providing patients with web-based~     electronically accessed patient information when compared to the provision of written~     information leaflets.~   "
134642|NCT01804959|"~     SSc-associated gastrointestinal (GI) involvement is common, with no effective treatment.~     Probiotics may have beneficial effects on symptoms as supported by one small open-label study~     (n=10) that demonstrated decreased bloating symptoms in SSc patients after 2 months of~     probiotics. This study aims to determine (i) whether 60 days of Vivomixx probiotics result in~     greater GI symptom improvement than placebo in SSc outpatients, assessed using an~     interview-administered 34-item Gastrointestinal Tract (GIT) questionnaire and (ii) whether 60~     days versus 120 days of probiotics result in greater GI symptom improvement in SSc~     outpatients, assessed using the GIT questionnaire.~   "
134643|NCT01804946|"~     The purpose of this study is:~        -  to assess clinical efficiency of Ergoferon for treatment of influenza~        -  to assess safety of Ergoferon for treatment of influenza~        -  to compare efficiency of Ergoferon and Tamiflu for treatment of influenza~   "
134825|NCT01802567|"~     The purpose of this study is to test the feasibility (ability to be done) of experimental~     technologies to determine a tumor's molecular makeup (gene expression profile) and mutations.~     This technology called the Pediatric Gene Analysis Platform includes a genomic report (gene~     expression profile) and a DNA Mutation Panel Report that are being used to discover new ways~     to understand cancers and potentially predict the best treatments for patients with cancer in~     the future.~   "
134644|NCT01804933|"~     Although deep anesthesia can produce skeleton muscle relaxation,unnecessary deep anesthesia~     often had adverse cardiac effects and was related to 2-year mortality in cancer patients.The~     use of muscle relaxants allowed the depth of anesthesia to be optimized.However, for many~     anesthesiologists,in fear of residual postoperative neuromuscular blockade,intraoprative~     administration of muscle relaxants had to be minimized in spite of poor surgical conditions.~      This study, however, is designed to test the hypothesis that profound neuromusclular blockade~     reduces muscle trauma caused by self-retaining retractor and thus cut down postoperative~     analgesic requirement.On the other hand,profound muscle relaxation can decrease postoperative~     diaphragmatic dysfunction and abdominal muscle trauma, which can improve postoperative~     pulmonary function.~   "
134645|NCT01804920|"~     Presently no generally effective treatments for tardive dyskinesia (TD) are available.~     D-serine is a naturally occurring amino acid that acts in-vivo as positive allosteric~     modulator at the glycine site associated with the glutamatergic NMDA receptor. Previous~     studies have suggested that D-serine may improve motor symptoms, including dyskinesias, which~     are caused by treatment with presently used antipsychotics drugs.~      The hypothesis under investigation in the present study is that D-serine adjuvant treatment~     may improve TD in schizophrenia patients diagnosed with this disorder.~   "
134646|NCT01804907|"~     To establish with a prospective randomized placebo-controlled study the feasibility of~     allied-health personnel-administered cognitive behavioral insomnia therapy (CBTI) as a means~     of improving HIV/AIDS treatment adherence.~   "
134647|NCT01804894|"~     Field tests are convenient, simple tests that serve as estimates of components of athletic~     performance like power speed, and agility. It is thought clinically, that those who do best~     at these tests will perform the best in their sport and/or be the least likely to get~     injured. The converse is also thought to be true. The objective of this study is to~     administer field tests to athletes at the beginning of each season and then follow athletes~     over several years, tracking their injuries and their performance statistics. In this way,~     the investigators can determine if the clinical supposition is true and that the results of~     field tests are associated with injury or performance~   "
134648|NCT01804881|"~     Dietary management is an integral aspect of self care for many chronic diseases. Craving~     Change™ is a standard program already offered at many Family Health Teams (FHT) to patients~     interested in being more mindful of their food choices. The program helps patients understand~     why they have difficulty with modifying behaviours associated with diet, addresses the impact~     of emotion on eating behaviour and provides affect regulation strategies. Existing literature~     shows that emotion has a strong effect on food choice and that emotion regulation can lead to~     improvements in food choice. Craving Change™, however, is currently not selectively offered~     at FHTs to patients deemed to be at higher risk of cardiovascular disease and has not been~     evaluated in that context. For this study, we propose to 1) Selectively target patients at~     higher cardiometabolic risk; and 2) Evaluate an effect of the program (as modified to address~     chronic diseases) through a pilot Randomized Controlled Trial (RCT). If found to be~     effective, the modified Craving Change™ program, called Beyond the Fork: A health-centred~     approach to managing chronic disease, could be broadly implemented within Family Health~     Teams.~   "
134649|NCT01804868|"~     Objective: The aim of this study is to assess the efficacy of a web tutorial based on case~     vignettes as a complementary tool for teaching literature critical assessment to nursing~     students, in terms of: 1) knowledge, 2) tutorial quality and acceptability and 3) students'~     point of view on research participation.~      Participants: Nursing second-year students from 3 universities in Paris (Paris Descartes~     University, Paris Diderot University and Paris 13 Nord).~      Design: A randomized controlled trial will assess the teaching efficacy of a case vignettes~     based tutorial compared to no tutorial. In order to preserve a minimal blinding of~     participants, the comparator will be a basic passive teaching presentation on internet. The~     students will be randomized in two parallel groups. They will be evaluated on a final case~     vignette, and will be invited to follow the other intervention after evaluation. The~     allocation of participants will be done by a computerized randomization list, the sequence~     will be created by an independent statistician with a ratio 1: 1: 1. Since the students~     follow courses in different nursing institutes for each university which may have different~     teaching content and organization, the randomization will be stratified by nursing institute.~     Allocation concealment will be provided because only the statistician will have access to the~     randomization list. All the participants will receive an individual mail linking them to his~     group dedicated website. In order to preserve a minimal blinding of participants, the~     comparator will be a passive presentation and the participants will not be informed of the~     intervention evaluated and will have the opportunity to follow the other intervention after~     the evaluation. In parallel, both groups will follow normally their university courses.~      Intervention: A case vignette is a clinical scenario based on clinical practice. It will ask~     a clinical problem the student will have to answer by reading a research article on a~     randomized clinical trial. Then he will have to answer questions about this article which are~     related to the major methodological points of a randomized trial. All these steps are~     available on a secure website.~      Outcomes: The primary endpoint will be the student's knowledge of critical assessment of~     randomized controlled trials. It will be measured by students' score on an evaluation case~     vignette with multiple choice questionnaires. The secondary endpoints will be the quality~     perception and acceptance of the tutorial and if the tutorial has modified their perception~     of research participation. Responses will be ranged by a 5-point Likert scale.~      Potential interests: This study takes place in the field of nursing universitary teaching.~     Nursing students have entered recently the universitary education system which enhances the~     nursing research, an emerging field in France.~      The investigators hope that this complementary teaching tool will enhance the knowledge and~     participation of nurses in research.~      Sample size expected: 506 participants.~   "
134650|NCT01804855|"~     Though face-to-face treatment of childhood obesity can be effective, it is time consuming and~     costly. This study will test whether treatment can be delivered via an Android app and~     whether such treatment reduces obesity.~   "
134651|NCT01804842|"~     This study compared the effects of delayed-release metformin (Met DR, EFB0027) administered~     once daily in the morning (qAM), administered once daily in the evening (qPM), and~     administered twice daily (BID) on circulating glucose concentrations and metformin~     pharmacokinetics (PK) in subjects with type 2 diabetes mellitus (T2DM).~   "
134652|NCT01804829|"~     The purpose of this study is to test the safety and efficacy of Civacir® to prevent the~     recurrence of Hepatitis C Virus (HCV) after liver transplant.~   "
134653|NCT01804816|"~     Acupuncture treatment may improve the cardiac function and the quality of life in heart~     failure patients. These effects may be related to the inhibition of sympathetic activity~     and/or increased vagal function. The suppression of inflammatory reaction with acupuncture~     treatment may also be associated with these outcomes. Specific aims include:~        1. To evaluate the effect of acupuncture treatment on human cardiac sympathetic/vagal~          activity~        2. To evaluate the effect of acupuncture treatment on cardiac function and functional~          capacity~        3. To evaluate the general health score of the quality-of-life with acupuncture treatment~        4. To explore the mechanism of acupuncture treatment on inflammation and nitrative stress~          in heart failure patients.~   "
134929|NCT01801176|"~     It's a monitoring study. The aim is to assess the progression free survival up to 3 years.~     Patients are not treated until progression. Search for scalability predictive factors and~     registration of treatments if progression.~   "
134654|NCT01804803|"~     The study aims to validate the clinical efficacy of a telemedicine- and web-based system~     platform for Self-monitoring of blood glucose (SMBG) data transmission and analysis in terms~     of improved metabolic control, assessed by measuring changes in HbA1c, in insulin-treated~     diabetic patients. The system platform involves (i.) systematic (real-time and anywhere)~     transmission of SMBG data to a decision supported software (DSS)-assisted server, (ii.)~     web-based analysis of data, and (iii.) feedback on patients and medical staff to implement~     metabolic control. The expected outcome is that using this telemedicine-based system with~     transmission of SMBG data, web-based analysis of data and medical feedback to patients and~     medical team will improve glucose control in insulin-treated individuals with type 1 or type~     2 diabetes mellitus.~   "
134655|NCT01804790|"~     National, multi-center, open-label,randomized, 2-arm phase III superiority trial, comparing~     neoadjuvant chemotherapy (CT) with mFolfirinox followed by preoperative chemoradiotherapy~     (CRT), versus preoperative CRT in patients with locally advanced rectal cancer.~   "
134656|NCT01804777|"~     The purpose of this study is to determine with the administration of amiloride, observe an~     enhanced natriuresis, reduction in blood pressure and weight compared to the administration~     of hydrochlorothiazide in Type 2 Diabetics.~   "
134657|NCT01804764|"~     Sepsis is widespread (1.8 million cases annually worldwide) and accounts for a very high~     mortality: 20-25% of all severe sepsis, 40-70% of all septic shock. The Surviving Sepsis~     Campaign (SSC) recommends a first 6 hours resuscitative bundle to improve patient's~     outcome. Despite this, the bundle is poorly performed, because of a superficial knowledge of~     the guidelines and several difficulties in their clinical implementation. In recognition of~     this, a sepsis six bundle is designed to facilitate early intervention with just three~     diagnostic and three therapeutic steps to be delivered by staff within 1 h.~      The aim of our study is to evaluate if an Educational and Organizational Intervention (EOI)~     could improve septic patient's outcome in no Critical Care Units. The second endpoint is to~     evaluate if the compliance to the sepsis six bundle could improve after this sort of~     intervention.~   "
134658|NCT01804751|"~     The purpose of this study is to build a model for the prediction of adverse perinatal outcome~     for preeclampsia in china~   "
134659|NCT01804738|"~     This study aims to test the following hypothesis in healthy lean young men:~        -  There are differences in glycemic response (GR) and insulin response (IR) between~          Chinese, Malay and Asian-Indian~        -  There are differences in GI values to the same food between ethnic groups~        -  There are ethnic differences postprandial GR and IR for high vs low GI foods~        -  Mastication, salivary amylase activity, gastric emptying rate and gut microbiota~          composition influences inter-individual glycemic and insulinemic variability~        -  Ethnic differences in mastication, salivary amylase activity, gastric emptying rate and~          gut microbiota composition determines the inter-ethnic glycemic and insulinemic~          variability~   "
134660|NCT01804725|"~     The objective is to study the effects of bicycle riding and bicycle seats on blood flow to a~     man's reproductive organs. It has been shown that bicycle riding can affect a man's ability~     to have an erection. Each year, newer and better bicycle seats come out but these seats have~     not been adequately studied for their effects on blood flow in the genital region.~   "
134661|NCT01804712|"~     There is now substantial evidence that B cells are recruited into prostate cancers by CXCL13~     released by the tumor cells. B cells release lymphotoxin which drives malignant cell~     proliferation through the NFkB pathway. This is a pilot trial in 18 patients to determine~     whether depletion of B cells by rituximab will result in a decrease in the extent of B cell~     infiltration of the prostatic cancer. The extent of infiltration in the diagnostic biopsy~     will be compared to that in the prostatectomy samples following administration of 4 weekly~     doses of rituximab.~   "
134662|NCT01804699|"~     Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) is an inherited condition that may~     cause life threatening irregular heart rhythms that often manifest as unexpected cardiac~     arrest or sudden death in early adulthood. The condition is difficult to diagnose and often~     is not noticed until a family member suffers a cardiac arrest or death.~      The Canadian National ARVC registry will collect data from Inherited Heart Rhythm Clinics~     across Canada.~      STUDY OBJECTIVES:~      Primary:~        1. To determine the natural history of ARVC (short/intermediate term), including risk of~          symptomatic arrhythmias and sudden death, for patients with the phenotype and those gene~          positive patients without phenotype evidence of disease.~        2. To understand risk factors for sudden death/appropriate ICD use in ARVC, including test~          characteristics/performance and their relationship to outcomes (ECG, Holter, signal~          averaged ECG, loop recorders, imaging, voltage mapping, T wave alternans, cardiac biopsy~          and biomarkers).~        3. To establish a phenotype genotype correlation, including comparison of patients with~          disease causing mutations, variants of unknown significance (VUS) and Task Force~          Criteria (TFC) positive, gene negative patients~   "
134663|NCT01804686|"~     The purpose of this study is to collect long-term safety and efficacy data for participants~     treated with PCI-32765 (Ibrutinib) and to provide ongoing access to PCI-32765 for~     participants who are currently enrolled in PCI-32765 studies that have been completed~     according to the parent protocol, are actively receiving treatment with PCI-32765, and who~     continue to benefit from PCI-32765 treatment.~   "
134664|NCT01804673|"~     The purpose of this study is to evaluate the safety and tolerability of the fentanyl~     iontophoretic transdermal (through the skin) system (fentanyl-ITS) in daily clinical practice~     for management of acute (a quick and severe form of illness in its early stage) moderate to~     severe post-operative pain (pain after surgery) including the comprehensibility and~     usefulness of the accompanying information material.~   "
134665|NCT01804660|"~     This study intends to explore the levels of MSRV expression by analyzing the levels of MSRV~     transcripts in blood, as well as the levels of the MSRV-Env protein in serum in the normal~     population. This study is important for establishing a baseline to analyze results obtained~     in MS patients (another dedicated study is performed in parallel in MS patients). The study~     will be conducted over one year in a cohort of healthy subjects. The MSRV RNA level, MSRV-Env~     protein levels, reverse transcriptase activity, inflammatory markers assessed by cytokines~     levels will be analysed to define control levels in the normal population and their variation~     during one year. The data obtained in this study in healthy controls will be compared to~     those obtained in a parallel similar study, GN-E-002, conducted in different types of MS~     patients.~   "
134666|NCT01804647|"~     This study intends to explore evolution of MSRV expression by analyzing the levels of MSRV~     transcripts in blood, as well as the levels of the MSRV-Env protein in serum of MS patients.~     The study will be conducted over one year in four cohorts of patients with different forms of~     MS (remitting-relapsing MS i.e. RRMS, primary-progressive MS i.e. PPMS and~     secondary-progressive MS i.e. SPMS) and in clinically isolated syndrome (CIS) patients who~     have suffered a single clinical event but do not comply with diagnosis criteria for definite~     MS. The MSRV RNA and MSRV-Env protein levels will be correlated with the clinical evolution~     of patients and with the reverse transcriptase activity, inflammatory markers assessed by~     cytokines levels. A control group of healthy subjects will be included (the study, GN-E-003,~     is performed in parallel and is part of another dedicated protocol).~   "
134667|NCT01804634|"~     The purpose of this study is to see if giving reduced intensity chemotherapy, haploidentical~     bone marrow, post-transplant cyclophosphamide and sirolimus is safe and feasible for patients~     with very high-risk solids tumors.~   "
134668|NCT01804621|"~     The purpose of the study is to implement a randomized control trial testing effects of~     information scanning on cancer prevention and screening behaviors in a population sample of~     50-70 year olds. Participants will receive one of five versions of an e-newsletter once/month~     for 12 months and will be asked to complete baseline, mid-point, and end-of-project surveys.~   "
134669|NCT01804608|"~     Assess pain, function, trunk and lower limbs kinematic during functional tasks after hip~     muscle strengthening versus hip muscle strengthening and sensory motor training in lower~     limbs.~   "
134670|NCT01804595|"~     This is a randomized controlled trial testing the efficacy of 4 sun protection~     interventions--education only; education and mailed sunscreen; education and text message~     reminders; and education, mailed sunscreen, and text message reminders--among Michigan~     Operating Engineers. Pre- and post-intervention surveys will be collected to determine~     changes in sunscreen use and sun burning, the primary outcome variables. The investigators~     hypothesize that all interventions will increase sunscreen use and reduce burning and that~     the education-only intervention will have the least effect of the 4 interventions while the~     education, mailed sunscreen, and text messaging arm will have the greatest effect.~   "
134671|NCT01804582|"~     Family-centered mental health treatment of children values and supports the role of parents~     in their child's recovery. However, medications are often the primary focus in community~     treatment. Young children, even preschool-age youth, are increasingly being treated with~     antipsychotic medication for serious mood and behavior problems. This medication may be~     necessary to address safety issues (such as severe aggression), but it can cause serious side~     effects, such as obesity. Also, medication-only treatment does not follow recommended care~     for these types of problems. Psychosocial treatments (for example, programs that coach and~     empower parents to manage their child's difficult behaviors) are highly recommended as part~     of comprehensive (medication and psychosocial) child treatment. Parent involvement in~     psychosocial treatment has clear benefits for their child's mental health and, unlike~     medication, the effects can last long after treatment is completed. However, problems related~     to access (for example, long waiting lists) and use (for example, parent mistrust of mental~     health services) of services are common. Maryland, like other states, has developed a system~     to improve medication safety by reviewing health information about the child to determine if~     the treatment is appropriate. This review reduces unnecessary medication treatment and makes~     sure that children have adequate health screening before starting any treatment. Children who~     are approved for medication treatment have moderate-to-severe mental health problems, which~     supports their need for comprehensive (medication and psychosocial)treatment, instead of~     medication-only treatment. In this study, investigators are partnering with parents/family~     advocates, child-serving agencies, and health providers to develop a Family Navigator Service~     to link with this medication program. Family Navigators are individuals who have cared for~     their own child with mental illness. The navigators will support parents, provide information~     on psychosocial treatment options, and address barriers to using services. The goals of this~     program are to improve use of psychosocial services, and to improve parent empowerment,~     support, and satisfaction with their child's mental health treatment. The investigators also~     expect that the Navigator Service will improve the child's overall mental health and reduce~     the likelihood that he/she will need a medication dose increase or another medication added~     over the initial treatment period. The Navigator Service will be provided for parents of~     public insured children who are 10 years old and have just been approved for antipsychotic~     medication treatment. The Navigator Services will be provided by phone, so this service can~     support families in both rural and urban settings. The investigators' long term goal is to~     develop a Family Navigator program that strongly supports Family-centered treatment of~     children and can be used to help families in other underserved areas beyond Maryland.~   "
134672|NCT01804569|"~     There will be significant differences between control and experimental group after the~     moxibustion intervention as to, subjective physical symptoms and quality of life.~   "
134673|NCT01804556|"~     Nocturnal leg cramps is involuntary strong contraction of leg muscle, mostly in calves. It~     occurs suddenly and induces pain. Patients with frequent nocturnal leg cramps suffer from~     sleep disturbance in company with pain. In the present study, we examined the effects of the~     myofascial trigger point injections, which are known to be helpful for ease of nocturnal leg~     cramps, on pain and sleep disturbance in patients with nocturnal leg cramps with trigger~     points on gastrocnemius muscle.~   "
134674|NCT01804543|"~     Evaluation of use of ranolazine in patients with stable heart pain with cardiac magnetic~     resonance imaging (CMRI) and phosphorous-31 magnetic resonance spectroscopy (31P MRS).~     Subsequent testing using these modalities will show improved oxygen to the heart muscle.~   "
134675|NCT01804530|"~     The objective of this study is to determine the safety, pharmacokinetics, maximum tolerated~     dose/recommended Phase 2 dose, and efficacy of PLX7486.~   "
134676|NCT01804517|"~     Headache disorders are prevalent, disabling, under recognized, under diagnosed and under~     treated. Migraine has a prevalence of 10% in men and 25% in women in Canada. The treatment of~     migraine is based on patient education (lifestyle habit modification, trigger avoidance), and~     pharmacological acute treatment and prophylaxis. A multidisciplinary approach allows a~     repartition of tasks between different health professionals.~      In a 2010 meeting, the Canadian Headache Society members supported the concept of Headache~     Centers, and a headache nurse was judged as an essential component of such centers.~      Gaul has reviewed the structured multidisciplinary approach that could be used in a headache~     centre and the existing studies using such structures. Five studies did include a headache~     nurse. No study did observe the impact of a nurse only. Resources in medical care are~     limited. One study did use a program of 96 hours, which does not seem realistic on the~     long-term and for a large pool of patients in a public hospital. Patients are not always able~     to pay for paramedical help such as physiotherapy and psychotherapy. Even if they do, finding~     a specialized therapist for chronic headache is difficult. Defining the role of a nurse and~     demonstrating the impact on patient care is therefore a first step in the concept of a~     headache center. Possible roles of a headache nurse according to Gaul are patient education,~     follow-up of the treatment plan, addressing patient queries, and monitoring of patient~     progress. The headache nurse may also participate in research projects. In a hospital~     Headache Clinic, the nurse may be involved in intra-venous treatments and blood sampling for~     research.~      In summary, evidence to demonstrate the impact of a nurse in a headache clinic is lacking. We~     propose to study this aspect prospectively. A study with positive findings would encourage~     health ministers to fund and support headache nurses for headache centers across Canada for~     headache management. Chronic headache and therefore chronic migraine would be a focus of such~     centers, since most patients seen in specialized centers are chronic.~      HYPOTHESIS: The addition of a headache nurse to the headache team will help the CHUM Migraine~     Clinic to improve treatment outcome, and reduce the burden of headache. This~     multidisciplinary approach will also allow a higher efficiency of the team.~   "
134677|NCT01804504|"~     The project is aimed at investigating the effect of nutrition education on knowledge,~     attitude and practice (KAP)of subjects who are frequently eating out, and the effect on~     metabolic parameters.~   "
134678|NCT01804491|"~     The aim was to investigate with a multi-segmental foot model the kinetic and kinematic in~     patients with a hallux rigidus, before and after different type of surgery.~   "
134679|NCT01804478|"~     SPECIFIC AIMS~      The limbs of diabetic patients are associated with decreases in capillary density, arterial~     inflow, and local blood flow of the leg. Decreased perfusion adversely affects wound healing~     and viability of tissue, especially in patients with peripheral vascular disease and~     diabetes. The investigators hypothesize that mild external compression can restore the~     decreases in skin and muscle blood flow and that there would be greater increases in~     microvascular blood flow induced by leg compression compared to healthy subjects. Blood flow~     will be measured using Photoplethysmography (PPG) before, during, and after external~     compression, and muscle oxygenation will be measured with Near Infrared Spectroscopy (NIRS).~      The specific aims are:~        -  To measure Muscle Blood Flow (MBF), Skin Blood Flow (SBF), and Bone Blood Flow (BBF)~          microcirculatory alterations in the leg and foot caused by mild external compression in~          healthy subjects and patients with diabetes.~        -  To measure muscle oxygenation changes in the leg and foot caused by mild external~          compression in healthy subjects and patients with diabetes.~        -  To optimize pressures of Continuous Compression to induce maximum microcirculatory blood~          flow in healthy subjects and patients with diabetes.~        -  To optimize compression pressures, duration, and frequency of Intermittent Pneumatic~          Compression (IPC) to induce maximum microcirculatory blood flow in healthy subjects and~          patients with diabetes.~        -  To measure microcirculatory response to compression in patients with diabetes~        -  Continue to validate of photoplethysmography as a tool for measuring microcirculation.~   "
134680|NCT01804465|"~     The purpose of this study is to find out what effects taking ipilimumab, as an immediate or~     delayed treatment, following completion of sipuleucel-T (SipT) treatment, has on patients and~     their prostate cancer.~   "
134681|NCT01804452|"~     The purpose of this study is to evaluate several different tests, including brain imaging,~     eye movement testing, body fluid samples, measurements of memory and other thinking~     abilities, and measures of functional independence in the hope that this information can be~     used to guide diagnosis and treatment of PSP and CBD in the future. Recent advances in our~     understanding of the biological causes of these diseases offer hope for new treatments. As~     such treatments are developed, sensitive and specific biological measurements (biomarkers)~     will be needed to provide precise and direct measures of the state of the brain, which will~     improve the statistical power of clinical trials. Brain imaging with Magnetic Resonance~     Imaging (MRI) has previously been used to measure disease-related changes in the brain. The~     goal of this study is to identify the best methods of analysis (including eye movements,~     imaging, and behavioral measures) for tracking PSP and CBD over time. In addition, certain~     biomarkers in the blood and cerebrospinal fluid might also be useful for following these~     diseases over time. This study will examine the value of blood and CSF biomarkers relative to~     brain imaging and functional measures.~   "
134682|NCT01804439|"~     Cardiovascular disease (CVD) is an important public health problem that affects millions of~     people worldwide. Associations between risk factors, such as smoking, dyslipidaemia or~     hypertension, and prevalent CVD are well documented. However, few studies have investigated~     associations with onset of disease. The initial manifestation of CVD, for example an episode~     of unstable angina, is important because it influences the prognosis, the quality of life and~     the management of disease. Furthermore, the extent to which social deprivation, alcohol~     consumption or atrial fibrillation affects presentation of CVD is poorly understood and~     deserves further consideration.~      Most previous studies have considered CVD as a single entity. However, differences in~     aetiology between coronary phenotypes suggest that risk factors may not be shared across~     specific coronary phenotypes and their relative importance is likely to differ for each~     phenotype. Gaining knowledge of these differences could provide insights into the~     pathophysiology of specific forms of CVD and could eventually lead to modification of~     recommendations for patient management and disease prevention.~      We propose to use the linkage of the national registry of coronary events to general practice~     records in the Clinical Practice Research Database (CPRD), to investigate whether~     demographic, behavioral, and clinico-metabolic risk factors differentially influence the~     onset of specific types of CVD.~   "
134683|NCT01804426|"~     Post-traumatic stress disorder, PTSD, is one of the most prevalent psychiatric disorders.~      As casualties of motor vehicle accidents, criminal acts or terrorism are arriving to the ER,~     it is almost impossible to conclude who will overcome his psychiatric trauma and will be able~     to return to his normal life course and who will be thrown out of his promising life~     trajectory.~      Current attempts to identify those who are at the greatest risk are still unsatisfactory,~     which comprise a therapeutic dilemma, since the interventions used to ameliorate and prevent~     the occurrence of PTSD in a high-risk patient, might be counter-productive and even~     precipitate the emergence of PTSD in lower-risk patients.~      Since PTSD is closely related to the Fight, Flight or Freeze reaction, it has much to do~     with the autonomic nervous system and the major stress hormone, cortisol. Despite many~     studies demonstrating the involvement of those factors in the development of PTSD, various~     attempts to profile the direction of the association between PTSD and cortisol abnormalities~     have yielded conflicting results.~      The introduction of a novel method of assessing the excretion of cortisol using residues in~     the human hair shaft, has allowed an unprecedented evaluation of its activity over a~     prolonged period of time.~      Using this novel method of cortisol assessment, the investigators aim to identify biomarkers~     that will be able to aid in the prediction of PTSD development ahead of symptoms emergence,~     and will enhance the understanding of the physiological mechanism involved and etiology of~     this disorder.~   "
134727|NCT01803854|"~     The Gulf War Era Cohort and Biorepository pilot project collected epidemiological, survey,~     clinical, and environmental exposure data from Veterans who served during the 1990-1991 Gulf~     War Era. Approved researchers will be able to use these data and the blood samples to do~     future research about the health of Gulf War Era Veterans.~      During the pilot, the recruitment response rate and processes were assessed. The results~     revealed several opportunities for improvement. For this reason, CSP 585 research activities~     transitioned to a qualitative phase to focus more on the Veteran voice. In this stage,~     research staff spoke with Gulf War Era Veterans through focus groups, interviews, and other~     activities such as events and meetings to learn more about Veterans' experiences and/or ideas~     on this and other Gulf War research projects. This phase provided new information that can~     help researchers create better recruitment processes for future projects involving Gulf War~     Era Veterans.~      For more information on CSP 585, please contact Brian Han at Byungjoo.Han@va.gov.~   "
134684|NCT01804413|"~     Hypothesis:~      Pegvisomant combined with the glucagon stimulation test (GST) can improve the accuracy of~     this test when used to diagnose adult GH and cortisol (steroid hormone)insufficiency.~      Study aims:~      Diagnosing GH and cortisol deficiency in adults requires a special test. At present, the~     insulin tolerance test (ITT) is considered the test of choice. However, this test is~     difficult to perform as it involves giving insulin through the veins to decrease blood sugars~     to very low levels, and this can be unpleasant, and cannot be performed in elderly adults and~     in those with a history of heart disease, seizure disorders or stroke. For this reason there~     is an urgent need for an alternative reliable test. At present, the GST is considered the~     alternative test to the ITT but its accuracy in obese patients and in those with diabetes~     remains unclear. Pegvisomant is a medication that can increase GH production in the body. The~     purpose of this study is to find out if combining pegvisomant with the GST can help improve~     the accuracy of this test so that it is comparable with the ITT in diagnosing adult GH and~     cortisol insufficiency.~      Study design:~      Subjects will be recruited from the Oregon Health & Science University Dynamic Endocrine~     Testing Unit. A written informed consent will be obtained and a screening interview will be~     carried out. During the screening interview, the study will be explained to the subject in~     detail. For women of child-bearing age, a pregnancy test will be performed. The subjects will~     then take part in three studies on separate days: (1) GST; (2) pegvisomant (1 mg/kg)~     injection into the abdomen 3 days before the glucagon stimulation test (ii) insulin tolerance~     test. For the GST, glucagon will be injected into the muscle and blood draws will be~     performed every 30 mins for 240 mins. For the insulin tolerance test, a blood draw will be~     performed and insulin will be given into the vein followed by blood draws every 15 mins for~     120 mins. The data from all three studies will be analyzed in the study where the peak growth~     hormone and cortisol levels for all three tests will be compared. A questionnaire will be~     used at the end of the study for the subjects to rank the level of preference of the three~     tests. The data of the study will be analyzed using a computer statistical program where the~     identity of the subjects will be coded to maintain confidentiality.~   "
134685|NCT01804400|"~     This study will assess the safety and efficacy of QAW039 alone and in combination with~     Montelukast in patients with allergic rhinitis (hay fever) using an environmental exposure~     chamber.~   "
134686|NCT01804387|"~     Lamivudine had been widely used for treatment-naïve chronic hepatitis B patients. However,~     development of antiviral resistance has been known as the major drawback: Incidence of~     lamivudine resistance was reported to be approximately 70% after 5 years (Lok AS et al,~     2003). For the treatment of lamivudine resistance, adefovir has been widely used (Lok AS and~     McMahon B, 2009). However, switching to adefovir monotherapy was also reported to be at high~     risk of resistance, 25% at year 2 (Yeon JE et al, 2006). Recently, adding adefovir on~     lamivudine was shown to be superior to switching to adefovir monotherapy by decreasing the~     adefovir resistance (Rapti I et al, 2007, Lampertico P et al, 2007). However, combination of~     adefovir and lamivudine does not increase antiviral activity compared with adefovir~     monotherapy in patients with lamivudine resistance (Peters MG et al, 2004). As many patients~     are still viremic with the treatment of lamivudine and adefovir over 1 year, the~     investigators need more potent combination of the drugs. Telbivudine is a new nucleoside~     analogue with potent antiviral activity. The previous phase III study has shown the~     superiority of telbivudine over lamivudine in HBeAg positive and negative subjects (Lai CL et~     al, 2007). Therefore, telbivudine plus adefovir may be a better treatment option than~     lamivudine plus adefovir for the lamivudine-resistant chronic hepatitis B patients. No study~     assessing the efficacy of telbivudine plus adefovir has been conducted for these patients.~     The aim of this study is to evaluate the safety and efficacy of telbivudine plus adefovir~     compared with lamivudine plus adefovir in lamivudine resistant chronic hepatitis B patients~     at the end of 1 year follow-up,~   "
134687|NCT01804374|"~     This is a trial for patients affected by metastatic or relapsed osteosarcoma which progressed~     after first or further line treatments. In this trial, all patients will be treated until~     progression or unacceptable toxicity with sorafenib and everolimus. The treatment with~     sorafenib and everolimus aimed to obtain a 50% rate of patients free from further progression~     of the disease after 6 months from study entry.~   "
134688|NCT01804361|"~     The purpose of this study is to determine efficacy and safety of Haporine-S eye drop for the~     patients with moderate to severe dry eye disease in a multicenter phase III clinical trial.~   "
134689|NCT01804348|"~     Clinical diagnosis of amniotic fluid leak will be determined, according the hospital standard~     procedure, using pooling test and/or sterile speculum examination and /or pH test, and~     AmniSure, N-Dia, Inc. (immunoassay for diagnosis of ruptured fetal membranes (ROM)). Amniotic~     fluid leak test, using the AL- SENSE 1-Step device, will be considered positive in case of~     presence of a blue or green or grey stain on a yellow background of the AL-SENSE 1-Step, as~     observed by the patient and the clinician (positive/negative).~   "
134690|NCT01804335|"~     The goal of this clinical research study is to learn if CD5789 is safe and tolerable when~     given to patients with early stage CTCL.~      CD5789 is designed to attach to tumor cells and change their genetic material. This may stop~     the growth of the tumor cells.~   "
134691|NCT01804322|"~     Epilepsy requires long-term drug treatment and is frequently associated with other clinical~     conditions. Combinations of antiepileptic drugs and other compounds are fairly common and~     increase with age. Adverse drug reactions and drug interactions are expected and may affect~     compliance, particularly in patients not receiving adequate information. Primary objective of~     the study is to verify if a comprehensive and standardized educational plan is followed by a~     significant reduction of the number of adult patients with epilepsy and comorbidity~     presenting clinically relevant adverse treatment effects. Secondary objectives include~     effects on number of adverse treatment events, health-related quality of life (HRQOL), direct~     medical costs, and patient's compliance. The study is a randomized, controlled, open-label,~     pragmatic trial. Included are consecutive adult outpatients with 1+ concurrent clinical~     conditions on chronic treatment and at least one clinically relevant treatment-related~     adverse event and/or clinically relevant drug interaction. Eligible patients will be~     randomized to receive a comprehensive and standardized educational plan (experimental arm) or~     to usual care, ie management of adverse event/drug interaction as done in clinical practice~     (control arm). The experimental plan consists in discussing with patient and caregiver the~     cause and nature of adverse event/drug interaction, the tolerability profile of each drug,~     the clinical manifestations associated with current drug interaction(s), contraindications of~     potentially interfering over-the-counter drugs, indications and benefits of suggested~     treatment changes, and withdrawal of potentially interfering, contraindicated or ineffective~     drugs. All patients will be seen at one, three and six months after admission.~      Expected results: The number of patients free from clinically relevant adverse treatment~     events and/or drug interactions in each treatment arm at end of study is expected to be~     higher in patients assigned to comprehensive and standardized educational plan compared to~     usual care (primary outcome). Patients on the experimental plan are also expected to be more~     commonly free from relevant adverse events and/or drug interactions at each intermediate~     visit, to present a lower number of adverse treatment events, to imply lower costs for~     medical contacts, hospital admissions, and drugs, to present better HRQOL scores, and to~     present less weekly treatment omissions.~   "
134728|NCT01803841|"~     The aim of this registry is to analyze several factors affecting the procedural success and~     clinical outcomes at 1 year of follow-up according to the approach site.~   "
134811|NCT01802749|"~     Bevacizumab has been found to prolong progression free survival in first line, and more~     recently, in second line treatment for platinum sensitive ovarian cancer patients who had not~     received prior treatment with bevacizumab.~      Recently reported data suggest that patients with colon cancer who receive bevacizumab in~     more than one line of therapy (beyond progression) have better results. In ovarian cancer,~     the role of bevacizumab administered in both first and second-line therapies needs to be~     defined.~      This study aims to evaluate whether administering bevacizumab in combination with~     chemotherapy in second-line therapy to patients with recurrent ovarian cancer who have~     received first-line bevacizumab will be more effective than chemotherapy alone.~   "
134692|NCT01804309|"~     Regional lymph node status is the most important prognostic factor for disease-free and~     overall survival in breast cancer. Accurate nodal staging can be achieved only by surgery.~     Today, in early-stage invasive breast cancers with clinically negative lymph nodes, minimally~     invasive sentinel lymph node biopsy (SLNB) is considered the gold standard of regional lymph~     node staging. To optimize the effectiveness of SLNB, precise pre-and intraoperative mapping~     of lymphatic drainage is important. The (SLNB) technique is not standardized. The most common~     and most accurate way of lymphatic mapping is performed with the combined application of a~     gamma-emitting isotope labeled substance and blue dye, the so-called double labeling~     technique. Functional lymphatic drainage of SLNB double staining in the mammary gland, skin~     and axilla present a number of uncertainties.~      According to the axillary, lateral thoracic and thoracodorsal veins, Ibusuki et al. divided~     the axillary region into four subregions: brachial (lateral), pectoral (anterior), central~     and subscapular (posterior) zones. They revealed clear relationship between the anatomic~     location and status of the SLN, also confirmed by Gallowitsch et al. SLN was detected in~     Level I in 96% and in Level II in 4% by SPECT/CT.~      Knowedge of relationships between the drainage of sentinel lymph node staining into the~     axillary subregions, location of the primary tumor, tumor size, SLN positivity and its~     location within the subregion are of particular importance in the decision making whether or~     not axillary lymphadenectomy (ALND) needs to be performed.~      In the prospective randomized phase 3 trial by Giuliano et al. (ACOSOG Z-11) ALND was not~     performed in early breast cancer patients with clinically negative axilla and~     breast-conserving surgery, for 1-2 macroscopically positive SLNs (10). After an average~     follow-up of 6.3 years, data were compared to the traditional ALND group and no difference~     was detected in 5-year overall survival or disease-free survival at 5 years.~      Aims of the investigation:~      To examine the location of SLN in the axillary subregion (anterior, posterior, central,~     lateral, apical) in patients with early breast cancer (T <5 cm).~      To statistically assess correlations between the location, size, histological parameters of~     primary breast tumor and the subregion of the SLN.~      To statistically assess SLN positivity and its location within the sbregion.~      To statistically assess subregional localisation of positive SLN and the number of all~     positive regional lymph nodes, to predict a limited number of cases with lymph node~     metastasis, based on the test results of the ACOSOG Z-11 trial, by which ALND could be~     omitted.~   "
134693|NCT01804296|"~     This research proposal aims to better understand the neurobiology of depression in~     adolescents and how repetitive transcranial magnetic stimulation (rTMS) may therapeutically~     impact brain function and mood. This investigation also proposes the first study to examine~     the efficacy of rTMS maintenance therapy in adolescents who have met clinical criteria~     following acute rTMS treatment. The magnetic resonance (MR) spectroscopy pattern of rTMS~     response will be analyzed according to previously established protocols.~   "
134694|NCT01804283|"~     1. Cardiopulmonary bypass and cardioplegic arrest could regulate expression of microRNAs in~          patients undergoing double valve replacement (aortic and mitral).~        2. The modulation of myocardial microRNAs by cardiopulmonary bypass and cardioplegic arrest~          may be rescued by ischemic postconditioning.~        3. Downstream effectors would also be affected.~   "
134695|NCT01804270|"~     This research proposal aims to better understand the neurobiology of depression in~     adolescents and how repetitive transcranial magnetic stimulation (rTMS) may therapeutically~     impact brain function and mood. This study will be the first to use a randomized,~     double-blinded, sham-controlled approach to the investigation of rTMS therapy for depressed~     adolescents. This approach will allow for the validation of rTMS treatment outcomes in the~     depressed adolescent population in a scientifically rigorous manner. The magnetic resonance~     (MR) spectroscopy pattern of rTMS response will be analyzed according to previously~     established protocols.~   "
134696|NCT01804257|"~     Feasibility study of using a digital health feedback system (DHFS) to monitor~     medication-taking and physiologic and behavioral parameters in patients with bipolar disorder~     or schizophrenia. Hypothesis: Using a digital health feedback system to characterize~     medication-taking behavior and activities of daily living is safe and tolerable in~     appropriately selected patients with bipolar disorder and schizophrenia.~   "
134697|NCT01804244|"~     The purpose of this study is to evaluate the pharmacokinetics and safety of TMC278 after a~     single oral dose of TMC278 25 mg tablet (27.5 mg as the hydrochloride salt) under fed~     conditions in healthy Japanese adult male participants.~   "
134698|NCT01804231|"~     Evaluate the impact of hybrid 18F-Fluoro-choline (18F-FCH) PET/MRI imaging on the clinical~     management of men with suspected recurrent prostate cancer post prostatectomy or~     radiotherapy.~      We hypothesize that hybrid imaging incorporating 18F-FCH PET/MRI imaging will be feasible and~     will lead to changes in management decisions among men being re-staged for suspected prostate~     cancer recurrence post-surgery or radiation who are potentially eligible for local salvage~     therapy.~   "
134699|NCT01804218|"~     The purpose of this study is to test the hypothesis that 18—22 week treatment with the~     inverse agonist nadolol will improve airway hyperresponsiveness in patients with mild asthma,~     compared to placebo.~   "
134700|NCT01804205|"~     The purpose of this study is to evaluate the effects of MgSO4 administration on the~     pharmacodynamics of rocuronium in patients with 60 or more years of age.~   "
134701|NCT01804192|"~     Traditional Chinese Medicine (TCM) practitioners believe that health can be maintained if the~     body has a balanced ying-yang or the qi flows in correct strength and quality along the~     meridians.Stimulation of the acupoints such as by acupuncture can awaken and modulate qi in~     the channels and is able to regulate and restore yin-yang balance.However, there are some~     drawbacks associated with acupuncture which may limit its applications. These include~     transmission of infectious disease, pneumothorax and other problems associated with organ~     punctures, cardiac tamponade, and broken needles with remnants migrating to other~     locations.Studies have shown that when TENS is applied over acupoints (Acu-TENS), it is~     effective in reducing dyspnoea in patients with chronic obstructive pulmonary~     disease,facilitate early haemodynamic recovery after open-heart surgery,relieve labor~     pain,increase in blood β-endorphin level,reduce blood pressure changes in normal healthy~     subjects and decrease airway resistance.Despite these promising results, how Acu-TENS works~     still remain unclear.This study aimed to investigate the effects of Acu-TENS over Hegu (LI4)~     and Quichi (LI4) on the autonomic nervous system activities and to investigate whether the~     subject could experience distinct sensation as deqi.~   "
134702|NCT01804179|"~     There are two parts to this study: (1) an information gathering phase leading to the~     development of new educational materials; and (2) a study to test the newly developed~     material. The information gathering phase has been completed. The purpose of this part of the~     research study is to test the usefulness and acceptability of new educational materials~     investigators have developed. Investigators will compare the new educational material to~     another widely available educational brochure. The goal is to see if the new educational~     material will change knowledge and behaviors about colorectal cancer and colorectal~     screening.~   "
134759|NCT01803425|"~     This PMS study aims to collect safety and reactogenicity data of Synflorix™ in healthy~     infants and children of the local population as per the licensing requirement of the Sri~     Lankan regulatory authority.~   "
134703|NCT01804166|"~     This study is designed to collect tissue samples from the biopsy specimen that was used to~     diagnose hepatosplenic T-cell lymphoma (HSTCL), additional patient information, and if~     possible, to obtain additional samples including a single blood sample, a buccal swab sample~     and/or a bowel tissue sample. Samples obtained will be stored by the sponsor for future~     testing. In addition, demographic and clinical patient information will be collected. The~     study will be conducted in North America. Patients eligible for enrollment include males or~     females with IBD of any age who have a confirmed diagnosis of HSTCL. Patients will be~     identified through the sponsor's adverse event reporting systems. Cases reported to the~     sponsor's Medical Information Center will be queried to ascertain if the reporter is~     interested in participating in the study. Where appropriate, cases may also be identified~     through the sponsor's new or on-going clinical trials and registries. Samples may be~     collected from living patients or from stored tissue of deceased patients. This study will~     not restrict or introduce any therapeutic interventions, including medications. All patients~     will continue to be managed by their personal physicians. No healthy subjects will be~     enrolled in this study.~   "
134704|NCT01804153|"~     Evaluate the feasability and security of the autologous ASC for the femenine stress urinary~     incontinence~   "
134705|NCT01804140|"~     This is a screening study to detect BRAF V600 mutation-positive patients for enrollment into~     clinical research studies of Zelboraf (vemurafenib). Tumor samples will be collected and~     analyzed from eligible patients with solid tumors (other than metastatic melanoma or~     papillary thyroid cancer) or multiple myeloma. All institutions with identified patients as~     defined by this screening protocol will have potential access to the separate vemurafenib~     protocol MO28072.~   "
134706|NCT01804127|"~     The aim of this study is to optimize the number of cycles of R-CHOP in patients with diffuse~     large B-cell lymphoma based on the interim results of PET/CT.~   "
134707|NCT01804114|"~     The primary endpoint of this study will determine if subjects receiving a continuous infusion~     of local anesthetic following laparoscopic ventral hernia repair, with the pain pump~     installed as described to treat post surgical pain will have a lower incidence of pain than~     those patients treated with a placebo, saline-filled pain pump.The secondary endpoint of this~     study will determine if subjects receiving a continuous infusion of local anesthetic~     following laparoscopic ventral hernia repair, with the pain pump installed as described to~     treat post surgical pain will have a lower utilization of narcotic analgesic medication than~     those patients treated with the placebo, saline-filled pain pump.~   "
134708|NCT01804101|"~     This randomized clinical trial studies liposomal cytarabine-daunorubicin CPX-351 in treating~     patients with untreated myelodysplastic syndrome or acute myeloid leukemia. Drugs used in~     chemotherapy, such as liposomal cytarabine-daunorubicin CPX-351, work in different ways to~     stop the growth of cancer cells, either by killing the cells, by stopping them from dividing,~     or by stopping them from spreading.~   "
134709|NCT01804088|"~     The FORMAT Clinical Study is a clinical trial to evaluate the safety and effectiveness of the~     Formula™ 535 Iliac Balloon-Expandable Stent in treatment of symptomatic vascular disease of~     the iliac arteries.~   "
134710|NCT01804075|"~     Hypothesis is that the effectiveness of opiate treatment with morphine will result in shorter~     duration of opiate medication treatment and fewer infants treated with a second drug.~   "
134711|NCT01804062|"~     The purpose of this study is to meet the respiration rate accuracy specifications for the~     study pulse oximeter monitoring system (study device)in a healthy volunteer population when~     compared to established technologies for measuring parameters related to respiration, such as~     Capnograph Respiration Rate (RR) (CO2).~   "
134712|NCT01804049|"~     Sarcopenia is the loss of muscle mass, strength and function with aging and is associated~     with increased disability, falls and fractures. Older adults with diabetes and prediabetes~     are insulin resistant and have a higher risk of developing sarcopenia. This study examines~     the use of metformin, an antidiabetic drug, for preventing the development of sarcopenia in~     older adults with prediabetes.~   "
134713|NCT01804036|"~     This study will determine whether Mind-Body Bridging (MBB), a mindfulness training program is~     more effective than a common sleep medication, Zolpidem, in treating insomnia. It will also~     investigate whether MBB is additionally beneficial for co-morbid conditions such as stress,~     PTSD, depression, etc, compared with that of Zolpidem.~   "
134714|NCT01804023|"~     The purpose of this study is to compare tests of vaginal insertion of applicators(visual~     inspection of returned applicators (VIRA), inspection of returned applicators under~     ultraviolet (UV) light, and DNA/protein markers) to determine which, if any, warrant use in a~     clinical trial of a new vaginal microbicide. The study will also determine whether indicators~     of semen can be detected on applicators and the degree to which they correlate with reported~     intercourse, and the correlation between vaginal bacteria detected by a vaginal swab and~     those detected from the applicator. In addition, the study will determine whether several~     factors that may be encountered in a clinical trial are likely to affect detection of these~     markers, including storage for 30 days vs. 7 days, wiping applicators after use, the presence~     of gel, and inter- and intra-woman variability. The study will also assess safety.~   "
134715|NCT01804010|"~     1. To assess the pharmacokinetic profile of ivabradine (S 16257) and its main active~          metabolite S 18982 in Korean healthy volunteers after oral administration of ivabradine~          at the doses of 2.5, 5, 10mg and after repeated oral administrations of ivabradine for~          4.5 days at the same doses twice daily versus placebo and to use the study results for~          bridging with Caucasian data.~        2. The pharmacodynamic profile of ivabradine versus placebo by measuring its effects on~          heart rate after single and then after repeated administrations.~        3. Clinical safety of ivabradine versus placebo.~   "
134760|NCT01803412|"~     This is a phase III, multicenter, open-label, uncontrolled extension study in male subjects~     with DMD open to eligible US and Canadian subjects who previously participated in the~     following studies of drisapersen: DMD114876, DMD114044 and DMD114349. Subjects will receive~     6mg/kg subcutaneous drisapersen on a weekly basis. For subjects who have previously~     experienced significant safety or tolerability issues or who experience these during the~     study, there is the potential of an alternate intermittent dosing arm that will be given as a~     regimen of 6 mg/kg weekly for 8 weeks followed by 4 weeks off treatment. For subjects who~     experience or have previously experienced significant safety/tolerability issues, side~     effects or reactions or intermittent dosing, intravenous dosing will be made available.~   "
134716|NCT01803997|"~     The purpose of the study is to evaluate an afterschool program to teach nutrition through~     basic cooking skills. This after school extracurricular program increases the students'~     confidence, knowledge, and skills for cooking as one of the first steps for dietary~     improvement. In addition to the life lessons students learn during this class, they gain~     self-confidence and become self-sufficient culinary experts that are capable of educating~     their siblings, parents, and social circles. This research project will test the impact this~     program has on nutritional knowledge, culinary efficacy, and nutritional choices made in and~     out of the home. The Pink and Dude Chef Afterschool Cooking Program was developed through~     STRIDE (Science through Translational Research in Diet and Exercise at California Polytechnic~     state University (Cal Poly) in San Luis Obispo, CA.~      Hypothesis: Middle school students participating in the Pink and Dude Chef afterschool~     cooking program will increase nutritional knowledge, culinary efficacy, motivation to eat~     fruits and vegetables, and fruit and vegetable intake compared to an attention control group.~   "
134717|NCT01803984|"~     Migraine is a very common, chronic/intermittent and disabling neurovascular headache disorder~     that has long believed to have no severe consequences. Recent evidence, however, strongly~     suggest that migraine is associated with increased risk of ischemic stroke and there is~     initial evidence that migraine is associated with structural brain changes independent of the~     occurrence of stroke.~      As migraine has strong links with the vascular system, it is plausible that vascular~     functions interact on the association between migraine and structural brain changes as well~     as cognition.~      Our primary objectives are to investigate: (i) the relationship of migraine and migraine~     subtypes on magnetic resonance imaging (MRI) changes in a cohort of patients with active~     migraine; (ii) the relationship of migraine on cognitive performance among patients with~     active migraine; and (iii) the relationship of migraine and migraine specifics with vascular~     functions and morbidity. As secondary objective, we investigate whether the association of~     migraine on structural brain changes or cognitive performance is modified by vascular~     functions.~      This will be an observational study conducted in the Headache Center in Bordeaux. 300~     patients have to be included (150 patients with migraine with aura and 150 patients with~     migraine without aura).~      Inclusion criteria are: all patients with a clearly defined migraine (as per~     IHS[International Headache Classification] criteria) who are aged 30 and older, are able to~     fluently speak French, and who are willing to participate.~      Exclusion criteria are: pregnant woman and patient who have a major psychiatric disease or~     major anxiety disorder or had a pacemaker (which would not allow to perform a MRI imaging).~      The cognitive status in the patient cohort will be ascertained by the Repeatable Battery for~     the Assessment of Neuropsychological Status (RBANS). In addition to the RBANS, we will use~     the HIT-6 (Headache Impact Test) and MIDAS (MIgraine Disability ASessment) and the depression~     scale CES-D (Center for Epidemiologic Studies Depression Scale).~      Vascular risk status will be assessed by measurement of blood pressure and reports of~     vascular risk factors. The endothelial function will be measured with a noninvasive~     Peripheral Arterial Tone (PAT) signal technology using the EndoPAT device (Itamar Medical~     Inc, Framingham, MA).~      For crude comparisons, chi-square tests will be used for categorical variables and t-test for~     continuous variables. Multivariable-multinominal modeling techniques will be utilized for the~     comparisons adjusting for potential confounding variables. All statistical tests will be~     two-tailed and a P <0.05 will be considered statistically significant.~   "
134718|NCT01803971|"~     the international recommendations don't explain the place of the intraosseous infusion in the~     reanimation of adult cardiac arrest; the goal of this preliminary study is to inform the~     delay for obtaining a vascular access by evaluation of a current strategy (using intraosseous~     infusion after one peripheral venous access failure) and to determine the potential failure~     risk factors of venous access.~   "
134719|NCT01803958|"~     This study was designed and developed in the Emilia Romania research and innovation program~     (PRI ER). The study does not have commercial sponsors and comes under the independent studies~     provided for by Ministerial Decree 17.12.2005. The PRI ER program will guarantee a~     contribution to the study for the first three years of recruitment through the regional~     Innovation Fund, to cover the costs of coordination and data management sustained by the~     Coordinating Center.~      Primary Objectives The study proposes to evaluate whether partial hypofractionated and~     accelerated irradiation of the sole surgical cavity, in patients suffering from breast cancer~     with low risk of local recurrence and who undergo conservative surgery, is not inferior to~     postoperative irradiation with conventional fractionation of the entire breast as regards~     local control (incidence of ipsilateral recurrences as prime event).~      Secondary Objectives Comparison of the global survivals, freedom from locoregional~     recurrences (with exception for contralateral tumors and second tumors), distant relapse-free~     (except for local or regional relapses or in the contralateral breast) in patients treated~     with conventional radiotherapy and accelerated partial radiation.~      To evaluate whether accelerated partial irradiation offers cosmetic results, acute toxicity~     comparable with conventional irradiation.~      Possible connection with other national and international studies Similar studies which~     nonetheless evaluate different methods of partial irradiation are currently underway.~      Study Design Multicenter phase III controlled randomized, unblinded study of non-inferiority.~      Number of cases Recruitment of 3302 patients is planned. Target Population of the Study Women~     aged = > 49, ECOG 0-2, undergoing conservative breast surgery for invasive breast cancer, pT~     1-2 (< 3 cm in diameter) pN0-N1 M0, unifocal, resection margins histologically negative (³ 2~     mm) at first intervention or after subsequent widening.~      Duration of the recruitment and of the subsequent follow-up A recruitment of 8 years is~     planned and a follow-up period of 5 years for an overall duration of the study of 13 years.~      Treatment~      The patients will be randomized to receive one of the following treatments:~      Trial arm 38.5 Gy total in 10 fractions (3.85 Gy per fraction), twice a day with an interval~     of at least 6 hours between the two fractions, for five consecutive working days.~      Control arm 50.0 Gy in 25 fractions (2 Gy per fraction), once a day for 5 days in the week.~      Endpoints Primary: survival free of local ipsilateral recurrence as prime event Secondary:~     global survival, locoregional recurrence-free, distant recurrence-free, acute and late~     toxicity (RTOG) and cosmetic result.~      Evaluation and Follow-Up Program Controls are planned during the radiotherapy, at the end of~     treatment, at 6 weeks, 3-6-12 months from the end of the radiotherapy and then once a year~     until the end of 5 years.~      Data Analysis Partial irradiation will be considered not inferior to the standard irradiation~     if the top extreme of the HR confidence interval at 95% (to endpoint) does not exceed the~     established value of 1.5 The study was sized in relation to the rate of local ipsilateral~     breast recurrences as prime event at 5 years and assuming that this rate in the standard~     treatment group is 4%, accepting as maximum Hazard Ratio inferior to 1.5 and error a and b~     equal respectively to 0.05 and 0.10 and test at an endpoint.~      The survivals will be calculated using the Kaplan-Meier method. The hazard ratio (HR) will be~     calculated using the Cox model and its confidence interval at 95% will be reported.~      Ethical Aspects and Informed Consent For participation in the study an informed consent is~     planned appropriately drawn up and submitted to the approval of the Ethics Committees.~      The clinical study will be carried out according to the ethical principles of the Helsinki~     Declaration, the GCP guidelines, the Italian laws and regulatory activities for carrying out~     clinical studies.~      Before formal commencement of the study its approval/sole opinion by the reference Ethics~     Committee of the proposing group is stipulated. The individual investigators of the different~     participating institutions are directly responsible for the submission for approval of the~     protocol by their Ethics Committees.~   "
134720|NCT01803945|"~     This is a randomized, double-blind, placebo-controlled, multiple-ascending dose study of~     orally administered AVE8112 in patients with Parkinson's Disease (PD).~   "
134721|NCT01803932|"~     Cluster randomized controlled trial to evaluate a male-focused primary prevention programme~     which used a men's only group discussion format to prevent intimate partner violence against~     women & girls through fostering knowledge and behaviour changes by: (1) increasing men's~     knowledge on the impact of violence against women; (2) promoting gender equitable~     beliefs/behaviours within relationships; and (3) developing anger management techniques.~   "
134722|NCT01803919|"~     The purpose of this trial is to make a comparison between the use of antiseptic silver~     alloy-coated silicone urinary catheters and the use of conventional silicone urinary~     catheters in spinal cord injured patients to prevent urinary infections.~   "
134723|NCT01803906|"~     The investigators are studying patients with undefined mitochondrial diseases to identify~     genetic mutations in nuclear or mitochondrial Deoxyribonucleic Acid (DNA). Most patients with~     suspected or known mitochondrial diseases have no genetic confirmation. The investigators~     expect that evaluating tissue samples from patients with mitochondrial disorders will lead us~     to discover mutations in new or known genes causing mitochondrial dysfunction.~   "
134724|NCT01803893|"~     PIF: biomarker of successful implantation To overcome the poor reproductive potential of~     embryos generated during in vitro fertilization cycles and the lack of markers enabling the~     identification of the most competent ones, it is common to transfer multiple embryos. However~     this practice is associated with the risks of multi-fetal pregnancies and high~     morbidity/mortality. Ideally, the availability of a marker specifically produced by viable~     embryos would permit the transfer of a single embryo (SET) without affecting the chances of~     pregnancy and, most importantly, capable to drastically reduce multiple pregnancies after~     IVF. In preliminary work, we demonstrated that no pregnancy resulted following the transfer~     of embryos where PIF was undetectable in culture media.(Keramitsoglou, T et al. ASRI Meeting,~     Hamburg, 2012) Using a non-invasive method of detection of PIF in the media surrounding the~     embryo will be correlated to live birth following single embryo transfer. By selecting only~     viable embryos, it will reduce the need for multiple IVF cycles, increase the rate of~     pregnancy outcome associated with SET, and will minimize multi-fetal pregnancy that has very~     high medical and societal costs both in pregnancy and after delivery.~   "
134725|NCT01803880|"~     The purpose of this study is to evaluate changes in clinical and imaging outcomes following~     arthroscopic treatment of a single medial femoral chondral lesion plus partial medial~     meniscectomy by Radiofrequency-Based debridement or Mechanical Debridement in subjects ≥~     eighteen (18) years of age.~   "
134726|NCT01803867|"~     This is a Phase I, multi-center, double-blind, randomized, placebo-controlled,~     dose-escalation study designed to evaluate safety, tolerability, pharmacokinetics, and~     immunogenicity of single intravenous (IV) administrations of rHIgM22 in patients with all~     clinical presentations of MS.~   "
134783|NCT01803113|"~     The objective of this field study is to demonstrate the clinical performance of the Sofia hCG~     FIA Test, using urine specimens from females of childbearing age.~   "
134930|NCT01801163|"~     This is a research study of a radiation treatment called stereotactic body radiotherapy~     (SBRT) plus a medicine called sorafenib. The purpose of this study is to evaluate the safety~     of SBRT plus Sorafenib to see what effects (good and bad) it has on the treatment of liver~     cancer.~   "
134729|NCT01803828|"~     Pathophysiology of diabetic cardiomyopathy (DCM) is yet unclear and gender differences at~     baseline and a specific treatment have not been indicated. The investigators already~     demonstrated the positive impact of phosphodiesterase type 5A (PDE5A) inhibition in men. The~     investigators' study aims to characterize DCM, measuring molecular and neuroendocrine~     assessment to relate to intramyocardial metabolism and cardiac kinetic. The investigators~     will perform a randomized, placebo-controlled, double-blind study enrolling 164 diabetic~     patients (females and males) with DCM, to evaluate gender responses to 6 months of PDE5A~     inhibitors (PDE5Ai). The investigators' study will describe gender differences in DCM~     features. The proposed research will test whether PDE5Ai could become a new target for~     antiremodeling drugs and to discover a molecular pathways affected by this class of drugs and~     a network of circulating markers for the early diagnosis, monitoring and prediction of~     response to treatment of DCM.~   "
134730|NCT01803815|"~     This prospective cohort study aimed to assess the phenotypic characteristics of OSA patients~     and their pattern of antihypertensive drugs consumption. The investigators also aimed to~     investigate a hypothetical association between ongoing anti-hypertensive regimen and Blood~     pressure control rates in these patients. Additionally, the investigators were also~     interested in trying to understand if the control of OSA may be influenced by the use of~     different classes of anti-hypertensive drugs.~   "
134731|NCT01803802|"~     This study is designed to help us better understand the factors that affect the sexual lives~     of women who have been sexually mistreated during childhood. With this study we hope to learn~     about factors that may be promising targets for future treatments of sexual problems related~     to past sexual experiences. The investigators hypothesize that women who have experienced~     early sexual abuse are more likely to have sexual problems in adulthood than women who were~     not abuse in childhood.~   "
134732|NCT01803789|"~     Metacarpal V fractures are injuries of the upper extremities. They occur frequently,~     primarily in young adults.These fractures are caused by falling on the fist, sports accidents~     and direct or indirect forces.~      Surgical intervention is necessary for fractures with a strong palmar angulation of the~     metacarpal bone or rotational deformity of the small finger. Due to the absence of guideline~     recommendations decisions about therapy are made taking into account logistical aspects,~     available hardware, individual expertise and preferences. The objective of the study is to~     compare the advantages and disadvantages of single versus double Kirschner wires for~     intramedullary fixation of metacarpal V fractures in order to standardize national therapy~     procedures.~      Primary hypothesis:~      In the surgical therapy of the dislocated and/or rotational deformed metacarpal V neck~     fracture, osteosynthesis with a single Kirschner wire is not inferior to osteosynthesis with~     a double Kirschner wire with regard to the functional outcome after 6 month, as measured with~     the Disabilities of the Arm, Shoulder and Hands Score (DASH).~   "
134733|NCT01803776|"~     The Physical Activity and Nutrition in Children (PANIC) Study is a single-centre physical~     activity and diet intervention study that provides novel scientific information on physical~     activity, nutrition, overweight, obesity, physical fitness, cognition, oral health, sleep,~     pain and other aspects of quality of life as well as health care costs in a population sample~     of children and adolescents. The main hypothesis of the study is that regular physical~     activity and dietary changes improve health and quality of life among children and~     adolescents.~   "
134734|NCT01803763|"~     The aim of this study is to investigate the pathophysiological mechanism of omalizumab in~     patients with documented chronic urticaria who have complaints under standard antihistamine~     treatment. With this study the investigators will assess the correlation between Fc-IgE~     receptor downregulation as well as functionality and clinical response to omalizumab~     treatment in patients with chronic urticaria. This may be an approach for other diseases as~     well, where Fc-IgE receptor crosslinking are essential. The treatment time is set for a total~     of 4 monthly applications of omalizumab. According to the dosage recommendations of recent~     studies, fixed doses of 300 mg omalizumab are administered subcutaneously.~   "
134735|NCT01803750|"~     The purpose of this study is to understand primary care provider's knowledge, attitudes, and~     barriers to promoting evidence-based cancer screening and prevention practices for physicians~     with large Latino patient populations. The investigators will ask providers information on~     cancer screening and prevention practices by conducting one-on-one interviews. In addition,~     they would like to develop a committee of community providers to help design and implement~     cancer screening and prevention programs specifically for Latino patients based on the~     interview findings.~   "
134736|NCT01803737|"~     The purpose of this study is to examine the feasibility of a campaign intervention for weight~     management compared to a standard behavioral weight loss intervention in overweight and obese~     adults.~   "
134737|NCT01803724|"~     The Irritable Bowel Syndrome (IBS) is a frequent disease, affecting between 10 and 20% of~     general population. Several pathophysiologic mechanisms have been described in IBS, among~     them the role of intestinal microbiota and small intestinal bacterial overgrowth (SIBO) have~     received special attention. SIBO has an adequate response to antibiotic treatment,~     unfortunately it didn't have an adequate diagnostic test: The classic gold standard -jejunal~     aspirate culture- has been criticized due to lack of standardization; the breath tests are~     simpler and widely available, but they have also been criticized due to inadequate diagnostic~     accuracy for SIBO. For this reason seems important to evaluate the performance of breath~     tests in terms of predicting clinical benefit of antibiotic therapy in IBS patients, rather~     than predicting a positive culture and SIBO.~      The objectives of this study are:~        1. Determine which breath test (lactulose or glucose) predicts better a potential clinical~          benefit of antibiotic treatment (Rifaximin) in IBS patients.~        2. Determine which of the multiples diagnostic criteria described for the lactulose breath~          test predicts better a potential clinical benefit Rifaximin in IBS patients.~   "
134738|NCT01803711|"~     To assess the efficacy of Omega 3 Fatty acid (Omega 3 FA) augmentation of desvenlafaxine~     (DVS) compared to placebo augmentation of DVS when used to treat depression and anxiety~     symptoms in patients with select medical conditions (cancer, cardiovascular diseases and~     diabetes).~   "
134931|NCT01801150|"~     Aim: To assess if six months of treatment with CPAP associated with conventional drug~     therapy, contribute to improved glycemic control in patients with type 2 diabetes and sleep~     apnea-hypopnea syndrome SAHS)~   "
134739|NCT01803698|"~     Background The Institute of Medicine (IOM) published guidelines in 2009 for optimal~     gestational weight gain (GWG) during pregnancy. These guidelines include trajectories for~     optimal GWG, based on a woman's pre-pregnancy body mass index (BMI), to be used throughout~     the duration of a pregnancy. Although there is a significant association between the total~     GWG recommended by these guidelines and maternal and perinatal outcomes, research has~     demonstrated that only approximately one-third of pregnant women have total GWG within the~     recommended amounts. Factors known to influence GWG include maternal age, parity, being in a~     committed relationship and smoking. In addition, recommendations by primary care providers~     have been shown to influence actual GWG. Women appreciate advice from their primary care~     providers, however, despite this, there is evidence that many patients report not being~     advised at all about GWG by their primary care providers.~      Relevance Excess weight gain in pregnancy has been shown to be a modifiable risk factor for~     excess weight in childhood, thus contributing to the intergenerational cycle of obesity.~     There is an opportunity to interfere with this cycle during the peri-pregnancy period, as~     women's motivation to engage in behaviour change is elevated and contact with their primary~     care providers is frequent.~      Research Question and Hypothesis What impact does training family physicians to regularly~     refer to the IOM trajectories and provide feedback about GWG (training in the use of IOM~     charts) during routine prenatal visits, compared to usual care, have on congruence of total~     GWG with IOM guidelines? Null Hypothesis: there is no difference in the congruence of total~     GWG with IOM guidelines between women whose family physicians were assigned to training in~     the use of the IOM charts and those whose family physicians were assigned to usual care.~      Objectives~      The following are the objectives for this study:~        1. To compare the congruence of total GWG with IOM guidelines between women whose family~          physicians were assigned to training in the use of IOM trajectories and those whose~          family physicians were assigned to usual care.~        2. To explore the relationship between other independent variables (maternal age, parity,~          committed relationship and smoking) and congruence of total GWG with IOM guidelines, for~          women whose family physicians were assigned to training in the use of IOM trajectories~          and for those whose family physicians were assigned to usual care.~   "
134740|NCT01803685|"~     This register study will collect the treatment information of the intracranial arteriovenous~     malformation patients in China. We aim to understand the current treatment situation of the~     disease in China.~   "
134741|NCT01803672|"~     Background.There is some evidence that engaging in regular moderate-intensity physical~     activity may help ameliorate cancer-related fatigue experienced by childhood cancer~     survivors, which eventually improve their quality of life. Nevertheless, there is growing~     concern about declining levels of physical activity in childhood cancer survivors.~      Purposes. To examine the effectiveness of an integrated adventure-based training and health~     education programme in promoting the adoption and maintenance of regular physical activity,~     reducing fatigue and improving the quality of life among Hong Kong Chinese childhood cancer~     survivors.~      Design and Subjects. A randomised controlled trial (RCT), two-group pre-test and repeated~     post-test, between subjects design was conducted. Recruitment of subjects was carried out~     through the Sunshine Parents Club, which is a non-profit voluntary organization with the aim~     to provide education and psychological support to parents of Hong Kong Chinese childhood~     cancer survivors.~      Intervention. Participants in the placebo control group received an amount of time and~     attention (leisure activities organized by a community centre) that mimicked that received by~     the experimental group. Participants in the experimental group joined a four-day integrated~     adventure-based training and health education programme, which contained education talks, a~     workshop and adventure-based training activities.~   "
134742|NCT01803659|"~     The purpose of this pilot study is to determine whether breast milk retinol concentration~     increases in response to daily supplementation with small amounts of vitamin A (~600 ug~     RAE/d), as either a b-carotene or retinyl palmitate, 6 d/week for 3 weeks. A secondary~     purpose is to evaluate sampling methods for collecting breast milk samples in a community~     setting. The results of this pilot study will allow us to determine whether milk retinol is a~     useful indicator for evaluating the impact of food-based interventions on the vitamin A~     status of lactating women.~   "
134743|NCT01803646|"~     The purpose of this research study is to test the safety and effectiveness of the study drug,~     AM-101. AM-101 is tested for the treatment of tinnitus that started as the result of an~     injury to the inner ear or due to middle ear inflammation (otitis media). Subjects with~     tinnitus can take part in the study, if their tinnitus started within the last 3 months.~   "
134744|NCT01803633|"~     Phase 2 of this study involves determining how consumption of cheese compared with a~     non-dairy cheese substitute influences inflammation over a six hour period.~   "
134745|NCT01803607|"~     The purpose of this study is to assess to what extent sequential treatment with odanacatib~     results in incremental gains in bone mineral density (BMD) over time in female participants~     who have received at least 3 years of bisphosphonate therapy. It was hypothesized that~     odanacatib treatment would increase femoral neck BMD relative to placebo after 24 months.~   "
134746|NCT01803594|"~     This study involves measuring subject's blood lipid responses after they consume a mixture of~     dietary fats of marine and dairy origin and vitamin supplements mixed into a milkshake, on~     three separate days. The investigators hope to learn more about how different food~     ingredients influence the metabolism HDL in individuals with low blood levels of HDL~     cholesterol.~   "
134747|NCT01803581|"~     The purpose of this study is to compare the efficacy and safety of an insecticide-free head~     lice product with that of a pyrethrum-based product.~   "
134748|NCT01803568|"~     Normal glucose uptake and metabolism in skeletal muscles are essential to keep blood glucose~     within normal range and hence, insulin resistance (possibly mediated by inflammatory~     processes) in skeletal muscle is a major pathogenic factor in type 2 diabetes. Physical~     activity seems to be of essential importance in the prevention and treatment of type 2~     diabetes. Myokines are proteins secreted from skeletal muscle that can execute important~     biological functions locally in the muscle (paracrine) or in other organs like the brain,~     heart and pancreas (endocrine). Evidence suggest that several interleukines and other~     cytokines are secreted by skeletal muscles. In the present project, the investigators will~     explore the relation between secreted myokines from muscle cells, insulin resistance and~     glucose metabolism before and after 12 weeks of exercise intervention. Subjects with normal~     as well as impaired glucose metabolism will be included in the study.~   "
134749|NCT01803555|"~     The primary objective of the study is to establish whether budesonide/formoterol fumarate~     dihydrate (BF) SPIROMAX 160/4.5 mcg is as effective as SYMBICORT TURBOHALER 200/6 mcg~     administered twice daily in patients with persistent asthma.~   "
134795|NCT01802957|"~     This study will introduce a multi-faceted intervention package which will be implemented in~     the newly developed network of St. Paul's Hospital Millennium Medical College (St. Paul) and~     the surrounding seven satellite health centers. The goal is to assess if this group of~     interventions improve the skills and confidence of providers to handle obstetric emergencies,~     if they streamline the referral process and if they result in improved maternal/newborn~     health outcomes.~   "
134932|NCT01801137|"~     A study to determine the efficacy of Everolimus(Afinitor®) as third line therapy in patients~     with transitional cell carcinoma of the urothelium which failed or progressed after two lines~     of chemotherapy~   "
134750|NCT01803542|"~     The purpose of this institutional protocol is to offer SBRT to selected patients in a~     controlled environment to refine treatment techniques (including dose/fractionation~     schedules) and standardize follow-up. SBRT has been in clinical use for over a decade in some~     institutions and the available data suggest that it can be used safely and with good results.~     This study will see how effective Stereotactic Body Radiation Therapy is for treating tumours~     in the lung and how often people have side effects. Radiation therapy is usually given once a~     day, often for a few weeks. In this study, study participants will receive high doses of~     radiation treatment to tumours in the lung for 3 to 10 treatment sessions over a total of~     about 1 to 2 weeks.~      Several reports indicate that this therapy might shrink tumours and control the cancer for~     extended periods of time. Although specialists started to treat patients with SBRT over 10~     years ago, it is still used in relatively few cancer centres.~   "
134751|NCT01803529|"~     Studies show that chest pain is a common complaint presented in both general practice and in~     emergency units. Musculoskeletal causes are common, but frequently overlooked. No studies~     about treatment of chest pain from the intercostal muscles were found by search in medical~     literature databases. The purpose of this study is to evaluate the effect of two different~     physical therapy interventions on intercostal pain in patients with stable heart disease.~      The hypothesis was that deep friction massage combined with heat-pack is more effective than~     heat-pack only.~   "
134752|NCT01803516|"~     The purpose of this study is to see how the look of telangiectasias (small dilated blood~     vessels) on radiated breast skin when altered by the pulsed dye laser affects a patient's~     overall well being.~      Patients will have a set of treatments with a pulsed dye laser. This is a laser that targets~     red blood vessels and delivers heat causing the telangiectasias to become smaller and less~     visible. The laser has been used safely to treat telangiectasias on the skin of patients who~     received radiation for breast cancer.~      Patients in the study will be asked to complete a questionnaire asking how they feel about~     the telangiectasias, their radiated skin and its effect on their daily lives. The~     questionnaire will be given at every visit. The improvement in the look of patients' radiated~     skin will also be compared to answers to the questionnaire. We hope the study will improve~     our understanding of how patients feel about the long term effects of radiation on their~     skin.~   "
134753|NCT01803503|"~     This study aims to find out whether the effect of docetaxel chemotherapy may be improved by~     combining it with another anti-cancer drug called sunitinib, which stops blood vessels from~     growing (anti-angiogenic agent). Sunitinib is an oral anti-angiogenic drug that has been~     approved for the treatment of kidney cancer, a rare form of soft tissue tumor called~     gastrointestinal stromal tumor, and a rare form of cancer in the pancreas called pancreatic~     neuroendocrine tumor. Sunitinib is usually given continuously at a dose of 37.5mg (3 pills)~     daily either alone or in combination with chemotherapy. However, there are studies which have~     shown that the continuous administration of sunitinib may reduce chemotherapy effectiveness.~     On the other hand, a short course of sunitinib before each chemotherapy cycle may sensitize~     the tumor to chemotherapy. This treatment strategy will be used in patients with different~     kinds of cancers with a commonly used chemotherapy drug, docetaxel. Ths study aims to~     evaluate if intermittent administration of low dose sunitinib before docetaxel chemotherapy~     can improve the treatment response in cancer patients.~      Study Hypothesis: Low dose, short course sunitinib at 12.5mg daily orally for 1 week prior to~     chemotherapy can normalize tumor vasculature and enhance delivery of chemotherapy into the~     tumor, and improve treatment response and progression-free survival.~   "
134754|NCT01803490|"~     Closed suction drains are commonly used following surgery, if the wound is expected to~     discharge significant amounts of fluid. To this date, no evidence base exists as to the exact~     post operative time period or discharge volume necessitating presence of a drain. In~     orthopedic common practice, drains are removed on the second post operative day, fearing the~     drain will serve as a point of entry for nosocomial infection. In this study, drains will be~     left in place as long as daily discharge volume exceeds 50cc, regardless of the amount of~     days following surgery. Daily cultures and antibiotic levels will be taken from the drains~     receptacle, to determine if and when the drains is colonized by aerobic bacteria.~   "
134755|NCT01803477|"~     The purpose of this study is to determine if the new vehicle formulations containing ingenol~     mebutate are as safe and effective as Picato® gel 0.05% (it's current vehicle formulation)~     when applied to AK lesions on the forearm for two consecutive days.~   "
134756|NCT01803464|"~     Cerebral palsy (CP) is a neuromuscular disorder that affects approximately 800,000~     individuals in the U.S. An estimated 70-80% of these individuals have spasticity which~     affects ambulation and requires management. Therefore, the treatment of spasticity is a~     primary goal of interventions for children with CP. One treatment widely used to reduce~     spasticity is Botox because of its ability to temporarily paralyze a muscle. However, no~     studies have determined the effect of Botox treatment on bone in humans. Also, a low~     magnitude vibration treatment has been shown to improve bone structure in the lower extremity~     bones of children with CP. The aims of this study are: 1) to determine the effect of Botox~     treatment in conjunction with a daily vibration treatment on bone mass and bone structure in~     children with spastic CP, and 2) to identify the mechanism that underlies the effect of Botox~     and vibration on bone.~   "
134757|NCT01803451|"~     The overall goal of this project is to understand the mechanisms by which gastric bypass~     surgery improves glucose metabolism.~      The central hypothesis guiding this project is that the reconfiguration of intestinal transit~     with the Roux-en-Y will increase the release of insulinotropic GI hormones, termed incretins~     that improve insulin secretion and glucose metabolism. The study is divided into three~     specific aims.~        1. To determine the role of incretin hormones on insulin secretion in patients with gastric~          bypass surgery using intravenous-oral hyperglycemic clamp.~        2. To compare incretin effect and glucose tolerance among patient who suffer from~          hypoglycemia after RYGB and asymptomatic surgical and non-surgical individuals.~        3. To quantify the contribution of GLP-1 to incretin effect enhancement following surgery.~   "
134758|NCT01803438|"~     The purpose of this study is to evaluate the effectiveness of Pulmonary Vein Isolation (PVI)~     performed with the Arctic Front™ Advance Cardiac CryoAblation Catheter System as first-line~     therapy in comparison with antiarrhythmic drugs (AAD) in patients with paroxysmal atrial~     fibrillation (AF).~   "
134933|NCT01801124|"~     Phase 4 study evaluating the effectiveness of EXPAREL when infiltrated into the the~     Transversus Abdominis Plane (TAP).~   "
134761|NCT01803399|"~     This is a randomized, partially-blinded, placebo and moxifloxacin-controlled, single dose,~     4-period, balanced crossover study. The primary objective of this study is to separately~     assess the effects of a therapeutic and supratherapeutic dose of GSK1322322 on the cardiac~     conduction (corrected QT interval [QTc]) compared with placebo in eligible healthy male and~     female subjects. Avelox (moxifloxacin hydrochloride) will be used as an open-label positive~     control in order to validate the sensitivity of the study in detecting QTc change.~     Approximately 56 healthy subjects will participate in the study for approximately 9 weeks~     i.e. 30 day Screening period, 4-week Treatment period, and a 7-10 day Follow-up period. There~     will be 4 treatment periods separated by at least 1 week. Subjects will be admitted to the~     clinical unit on Day -1 of each dosing period. Each subject will receive each of the four~     treatment sequences (GSK1322322 1200 milligram [mg] intravenous [IV] over 60 minutes x 1~     dose, GSK1322322 3000 mg IV over 60 minutes x 1 dose, GSK1322322 Placebo IV over 60 minutes x~     1 dose, moxifloxacin 400 mg administered orally x 1 dose) on Day 1 of each Treatment period~     in a randomized fashion. Twelve-lead electrocardiogram (ECG), continuous Holter monitoring,~     laboratory tests, vital sign measurements, and serial pharmacokinetic samples will be~     collected for up to 24 hours following each treatment. If no clinically significant~     abnormalities are noted, subjects will be discharged from the clinical research unit after~     the completion of all assessments on Day 2 in each period and return approximately one week~     later for the next dosing period. Each individual subject will follow the same dosing~     schedule at every period. A Follow-up visit will be conducted 7-10 days after administration~     of the last dose of study medication in treatment period 4.~   "
134762|NCT01803386|"~     The purpose of this protocol is to test a new Electrical Impedance Myography (EIM) device and~     study its reliability and ability to differentiate ALS patients from healthy controls.~   "
134763|NCT01803373|"~     The purpose of this study is to test the relative bioavailability (extent and rate to which a~     drug is taken up by the body) of TMC207 following the administration of two pediatric~     formulations of TMC207 taken with and without food in healthy adult participants.~   "
134764|NCT01803360|"~     The purpose of this study is to determine whether neridronate is effective in the treatment~     of pain related to bone marrow oedema in patients with osteoarthritis of the knee.~   "
134765|NCT01803347|"~     Efficacy of treatment of perianal fistula with mesenchymal stem cells and surgery~   "
134766|NCT01803334|"~     This is a study looking at patient's satisfaction with incision site and location after~     undergoing minimally invasive gynecologic surgery. (Laparoscopy) The study group will have~     the anticipated incision marked with a washable marker on their abdomen. The control group~     will have preoperative counselling as usual. After surgery, will assess patient's~     satisfaction with the incision scar.~   "
134767|NCT01803321|"~     This study is a pilot, ascending dose, multi-center, randomized, double blind, placebo~     controlled, pediatric study conducted in three phases.~   "
134768|NCT01803308|"~     The purpose of this study is to compare the safety and tolerability of ascending doses of SB~     9200 given for up to 14 days to subjects with chronic Hepatitis C infection.~   "
134769|NCT01803295|"~     In the proposed study the investigators aim to evaluate the effect of the standard of care~     dose (40mg) of MMC mixed with TC-3 gel (with sustained release mechanism on the drug) on low~     risk recurrent NMIBC lesions and to compare our findings to instillation with the standard~     mode of instillation- 40mg MMC in water in order to examine our hypothesis that MMC mixed~     with TC-3 gel will have at least non-inferior and even superior results over the standard~     instillation mode~      The investigators believe that this study is of importance of several aspects:~        1. It evaluates a new mode of bladder instillation that may bypass the drawbacks of the~          current instillation mode.~        2. If proved effective this mode of treatment might save the need of TURBT performance and~          serve as a new mode of tumor ablation.~        3. Even if proved partially effective this mode of treatment will diminish tumors size or~          number thus enable a more limited TURBT procedure.~        4. This mode of treatment will enable immediate medical attendance to the patient's tumor~          recurrence without the waiting period (resulting from queues in the medical centers) for~          TURBT, which might improve the patient's prognostic outcome.~        5. If this experimental treatment will prove to have a better ablative effect, this could~          be translated to a better prophylactic effect of tumor recurrence.~   "
134770|NCT01803282|"~     This is an open-label, multicenter, sequential dose-escalation, and expansion study to~     evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of andecaliximab~     (formerly GS-5745) alone and in combination with chemotherapy.~      The study consists of 2 parts (Parts A and B). Participants can only qualify for and~     participate in 1 part.~      Part A is a sequential dose escalation to determine the maximum tolerated dose of~     andecaliximab in participants with advanced solid tumors that are refractory to or intolerant~     to standard therapy or for which no standard therapy exists. In Part A, participants will~     receive andecaliximab only. Part A will consist of between 12 to 48 participants.~      Part B is a dose expansion to obtain additional safety and tolerability data for~     andecaliximab in participants with advanced pancreatic adenocarcinoma, lung adenocarcinoma,~     lung squamous cell carcinoma, esophagogastric adenocarcinoma, colorectal cancer, or breast~     cancer. In Part B, participants will receive andecaliximab in combination with~     standard-of-care chemotherapy. Part B will consist of between 115 to 295 participants.~      Please note the study is currently only recruiting in the breast cancer cohorts.~   "
134771|NCT01803269|"~     This randomized phase II trial studies how well giving topotecan hydrochloride or~     cyclodextrin-based polymer-camptothecin CRLX101 works in treating patients with recurrent~     small cell lung cancer. Drugs used in chemotherapy, such as topotecan hydrochloride, work in~     different ways to stop the growth of tumor cells, either by killing the cells or by stopping~     them from dividing. Cyclodextrin-based polymer-camptothecin CRLX101 may stop the growth of~     tumor cells by blocking some of the enzymes needed for cell growth. It is not yet know~     whether topotecan hydrochloride is more effective than cyclodextrin-based~     polymer-camptothecin CRLX101 in treating patients with lung cancer.~   "
134806|NCT01802814|"~     The main goal of this study is to improve the outcome of children and adolescents with~     standard risk first relapsed acute lymphoblastic leukemia. Furthermore, goal is to set up a~     large international study group platform allowing for optimization of standard treatment~     strategies and integration of new agents.~   "
134807|NCT01802801|"~     The purpose of this study is to determine the intra- and interobserver agreement.~   "
134808|NCT01802788|"~     This study will further assess the performance and safety profile of the commercially~     available Portico Valve implanted, using the Delivery System and the Loading System, in~     patients with severe symptomatic aortic stenosis through 5 years of follow-up.~   "
134998|NCT01800279|"~     The purpose of this study is to determine whether kinesitherapy techniques and a myofascial~     therapy protocol are effective in the treatment of temporomandibular joint dysfunction in~     patients with fibromyalgia syndrome.~   "
134772|NCT01803256|"~     The full body marker sets that are typically used in opto-electronic 3D gait analyses either~     disregard the spine entirely or regard it as a rigid structure. Therefore, the purpose of~     this study is to identify the possibilities and limitations of an enhanced trunk marker set~     for the measurement of spine dynamics during gait in adolescents with and without structural~     spine deformities.~      It has been hypothesized that the enhance trunk marker set:~        1. is a valid method for the measurement of spine deformations in the sagittal, frontal and~          indirectly transverse planes.~        2. is an applicable and reliable method for the measurement of spine dynamics during gait~          in healthy adolescents and in patients with structural deformities such as seen in~          scoliosis.~        3. is sensitive enough to distinguish the spinal movement pattern during gait measured in~          scoliosis patients from the one measured in healthy adolescents.~      To verify the hypotheses, the following measurements will be carried out:~        -  Biplanar radiographs (a-p and lateral) with radio-opaque markers in scoliosis patients.~        -  Instrumented gait analysis with a standard full body marker set and the enhanced trunk~          marker set in scoliosis patients and healthy controls.~   "
134773|NCT01803243|"~     Measuring spine dynamics is a necessity in order to better understand gait deviations~     throughout the whole body and to evaluate treatment effects on spinal movement during gait.~     However, the full body marker sets that are typically used in opto-electronic 3D gait~     analyses either disregard the spine entirely or regard it as a rigid structure. Therefore,~     the purpose of this study is to use an enhanced trunk marker set in order to evaluate the~     biomechanical effects of lower extremity treatments on spine dynamics in patients with~     different pathologies.~      It has been hypothesized that~        1. the enhanced trunk marker set is a reliable method for the measurement of spine dynamics~          during gait in patients with deviations occurring secondary to leg length inequality.~        2. the enhanced trunk marker set is a reliable method for the measurement of spine dynamics~          during gait in patients that present both primary and secondary deviations such as seen~          in hemiplegic and diplegic cerebral palsy.~        3. treatment by means of either a shoe insole or a modified shoe with sole lift on the~          shorter side has an effect on spine dynamics during gait in patients with leg length~          inequality.~        4. treatment by means of an ankle foot orthosis to control the foot position has an effect~          on spine dynamics during gait in patients with hemiplegic and diplegic cerebral palsy.~      To verify the hypotheses, instrumented gait analyses with a standard full body marker set and~     the enhanced trunk marker set will be carried out before and immediately after an orthotic~     lower extremity treatment in the respective patient group.~   "
134774|NCT01803230|"~     Creatine supplementation may improve cognitive function in elderly and vegetarian~     individuals. This study aims to investigate the role of creatine supplementation on cognitive~     function in healthy children.~   "
134775|NCT01803217|"~     Unnecessary right ventricular pacing has been shown to be detrimental in recipients of~     implantable pacemaker or defibrillators.~      The ADVANTAGE study evaluates the efficacy of two pacemaker based algorithms~     (atrioventricular hysteresis function versus mode switch to atrial pacing) to reduce right~     ventricular pacing.~   "
134776|NCT01803204|"~     To evaluate the effectiveness in the use of an educational material through: Assessment of~     knowledge about post-operative orthognathic surgery; assessing levels of anxiety with the~     survey of Anxiety Inventory-STATE-TRAIT; clinical evaluation of self-care in the management~     of postoperative signs and symptoms~   "
134777|NCT01803191|"~     The purpose of this clinical trial is compare the incidence of symptomatic or asymptomatic~     bacteriuria after transrectal ultrasound guided prostate biopsy using a single dose of~     fosfomycin 3 g one hour before the biopsy compared to observed with the use of a single dose~     of ciprofloxacin 500 mg 1 hour before biopsy.~   "
134778|NCT01803178|"~     The main aim of the study is to investigate, in humans, the effect of plant sterols on~     vascular function by measuring flow-mediated dilation (FMD).~      This study also aims to study the effect of plant sterols on pulse wave velocity (PWV),~     aortic augmentation index (Aix), central blood pressure (CBP), office blood pressure (BP),~     blood lipids and plasma plant sterol concentration. At last, the effects of plant sterols on~     z-scores of circulating biomarkers of endothelial dysfunction and low-grade inflammation will~     be assessed.~      For all study outcomes, effect sizes and 95% confidence intervals will be estimated.~      Hypothesis: Based on available evidence, it is hypothesized that plant sterols modestly~     increase FMD.~   "
134779|NCT01803165|"~     In this investigation, the investigators will attempt to demonstrate that patients who have~     received nerve blocks (regional anesthesia) prior to open surgical vascular bypass of the~     lower extremities (infrainguinal bypass grafting) will have improved surgical outcomes namely~     a reduction in the rates of death, wound infection, graft thrombosis, graft revision, and~     amputation. As well, the investigators anticipate that patients who have undergone regional~     anesthesia for infrainguinal bypass grafting will have improved secondary outcomes with~     respect to a decreased length of stay, narcotic consumption, nausea and vomiting,~     post-operative cognitive dysfunction, major cardiac events, post-operative pain, and~     hyperglycemic episodes.~   "
134780|NCT01803152|"~     The use of adjuvant vaccination with autologous dendritic cells (DC) matured in situ after~     being loaded with tumor lysates derived from autologous refractory sarcoma tissue will be~     safe, feasible and potentially beneficial for patients diagnosed with sarcoma. This~     vaccination will result in evidence of immune stimulation against tumor antigens. In~     addition, combining myeloid derived supressor cells (MDSC) inhibition using gemcitabine with~     DC vaccination in this method will be safe and feasible and show improved immune parameters~     over DC vaccination without MDSC inhibition.~   "
134781|NCT01803139|"~     Women diagnosed with an early stage cancer of the breast usually have the cancer removed by~     lumpectomy and then have radiation treatments to the entire breast. In 2008 the investigators~     published the result of a multicentre study showing that breast Intensity Modulated Radiation~     Therapy (IMRT) significantly reduces the occurrence of radiation burns. In this study the~     investigators will recall all patients at 8 years to assess if this technique also reduces~     permanent side effects including pain and cosmesis.~   "
134782|NCT01803126|"~     Biofilm has been identified as the major bacterial phenotype contributing to atherosclerosis.~     It has become very important to evaluate atherosclerosis and the role of biofilm using~     advanced technologies. It is also important to understand wound biofilm at a genetic and a~     molecular level.~   "
134784|NCT01803100|"~     Overall Aim: To describe and to assess the change in the temporal profile and transmission of~     microorganisms between patients and environmental surfaces after admission into a newly~     disinfected room.~      Study Activities: Investigators will prospectively and concurrently perform microbiological~     sampling of body sites (nose, throat, axillae, perineal and wounds) high touch surfaces (e.g.~     bedside rail, bed surface, toilet seat, IV pump and tray table) for consented adult patients~     admitted to freshly cleaned patient rooms. The microbiological sampling of body sites is~     already performed in many units of the hospital as standard of care. Infection and~     readmission related data from enrolled patients will be collected for upto 1 year after~     enrollment.~      Data analysis: Standard surveillance for hospital-acquired infections will be performed by~     the infection control group of the hospital. The identity and the nature of micro-organisms~     colonizing the high touch surfaces of rooms and of patient's body sites will be determined~     and compared. Risks involved is no more than minimal risk.~   "
134785|NCT01803087|"~     This clinical pharmacology want to investigate the systemic availability of BDP/B17MP (active~     metabolite of BDP) and formoterol after single oral inhalation of CHF 1535 100/6 pMDI with~     and without spacer device (AeroChamber Plus™) and in comparison to a free combination of BDP~     pMDI plus formoterol pMDI licensed products; this will be additionally compared to the~     systemic exposure in adults without the spacer device.~   "
134786|NCT01803074|"~     The primary purpose of this study is to study the safety and tolerability of a HIV drug and~     to evaluate a decrease of HIV-1 virus level in blood after treatments in HIV-1 infected~     patients~   "
134787|NCT01803061|"~     Patient-reported information on outcomes such as symptom-burden and health-related quality of~     life (QoL) is regarded as a useful tool to improve quality of care in clinical cancer~     research. However, integrating patient-reported information in the routine clinical practice~     is often difficult due to excessive time use and practical barriers. Electronic data~     acquisitions, where the treating physician has immediately access to the patient-reported~     data in the subsequent consultation, have been shown to be beneficial in the everyday~     clinical decision making.~      The aim of this study is to develop and test a computer-based patient-reported assessment~     tool that will assist the clinicians in tracking long term and late effects in head and neck~     cancer patients and investigate if the tool leads to improved symptom assessment of a range~     of head and neck cancer specific symptoms, which again may lead to improved symptom control~     and enhanced quality of life in the patients.~      Patients with a diagnosis of head and neck cancer attending the oncology outpatient clinics~     at Herlev Hospital and physicians and nurses who work at the clinic will be invited to~     participate. The assessment tool will be developed with inspiration from prior international~     studies of symptom assessment in head and neck cancer patients and tailored so that it will~     fit into a Danish context. The tool will be tested in a controlled intervention study. In the~     intervention group, patients will complete the assessment tool in the patients waiting area~     prior to every scheduled consultation. The result will then be printed and provided to the~     treating physician. In the control group, the patients will complete the assessment tool~     prior to consultations. However, the data will not be provided to the physicians at any time.~      To assess the impact of the tool on number of symptoms addressed during consultations and~     patients' overall quality of life, medical records will be reviewed for before start of~     intervention and again at 6 and 12 months follow-up. The patients will also complete the~     EORTC QLQ-C30 and the EORTC QLQ-H&N35 at baseline and at 6 and 12 months follow-up.~     Furthermore, we will conduct a qualitative evaluation (semi structured interview and~     participant observations) of attitudes among clinicians and patients regarding the use of~     tool at the point of care.~   "
134788|NCT01803048|"~     Abnormalities in structural and functional connectivity between brain regions have been~     suggested as putative biomarkers of mild traumatic brain injury (TBI) and significant~     contributors to neuropsychological functioning and injury outcome. The purpose of this study~     is to use two advanced magnetic resonance imaging (MRI) techniques called diffusion-weighted~     imaging (DWI) and resting state functional MRI to compare structural and functional~     connectivity between individuals with documented mild TBI and healthy controls. To evaluate~     the significance of structural and functional connectivity for behavior, the brain imaging~     data will then be related to measures of cognition and emotion. Over a 4-year period, 150~     adults with documented mild TBI and 30 healthy controls will participate in the study.~      The study will investigate the following questions and hypotheses:~        1. Evaluate the DWI metric fractional anisotropy (FA) as a measure of white matter~          integrity across multiple stages of recovery following mild TBI relative to healthy~          controls. It is hypothesized that mild TBI will be associated with greater white matter~          abnormalities than healthy controls.~        2. It is hypothesized that there will be a relationship between FA, cognition and emotion~          as a function of the injury.~        3. It is hypothesized that functional connectivity will be related to FA.~   "
134789|NCT01803035|"~     The purpose of this study is to determine the efficacy of the topical antibiotic LTX-109 in~     terms of clinical and microbiological response in treatment of impetigo.~   "
134790|NCT01803022|"~     The study purpose is to document the prescription and the use of Low Molecular Weight Heparin~     in usual medical practice in patients with cancer and established Venous Thromboembolism.~     This study also aims at gathering epidemiological data on the Low Molecular Weight Heparin~     therapy of Venous Thromboembolism in patients with cancer.~   "
134791|NCT01803009|"~     Little is known about the impact of risk assessment tools on decision-making by patients and~     clinicians. In particular, even though the NCI Colorectal Cancer Risk Assessment Tool is one~     of the most prominent risk assessment tools available, no study has quantified its usability~     or impact on decision-making or uptake of screening. In this study, we will measure patients'~     satisfaction with the NCI CRC RAT, their perception of its usability and helpfulness, and its~     impact on their decision-making and behavior. In addition, we will assess the impact of~     adding information about their chance of having an advanced adenoma.~   "
134792|NCT01802996|"~     This purpose of this study is to evaluate the evaluate the efficacy of Magnesium~     Isoglycyrrhizinate Injection in the prevention of antineoplastic chemotherapy related acute~     liver injury.~   "
134793|NCT01802983|"~     The multiple organ dysfunction syndrome (MODS) has remained the major factor contributing to~     prolongation of intensive and mortality. It is reported that the mortality rates have varied~     between 20% and 100%, depending on number, severity, duration, type and combination, and~     definition of dysfunction. In our study, the investigators explore some comprehensive~     treatment technology to improved outcomes of MODS patients.~   "
134794|NCT01802970|"~     To determine the safety of administering anakinra plus the physician's chemotherapy choice~     (TPC) of nab paclitaxel, capecitabine, eribulin, or vinorelbine in patients with metastatic~     breast cancer (MBC), as well as determining blood immune cell transcriptional signatures in~     patients who undergo IL-1 receptor blockade.~   "
134809|NCT01802775|"~     This study is a randomized, open-label, blinded endpoint, parallel-group, active-control,~     multi-center, proof-of-concept study in subjects with Peripheral Arterial Disease (PAD),~     designed to assess the safety and potential efficacy of adding edoxaban to aspirin following~     femoropopliteal endovascular intervention, with or without stent placement, relative to~     current treatment practice with clopidogrel and aspirin.~   "
134796|NCT01802944|"~     Following their deployment to the 1991 Gulf War, many veterans (GWV) reported a constellation~     of unexplained health symptoms; common among them were attention and memory difficulties,~     fatigue, joint pain, headaches, gastrointestinal complaints, and mood and sleep problems.~     Despite the passage of time, the symptom complex persists for many veterans. Indeed, it is~     estimated that at least 25 percent of GWV (nearly 170,000 veterans) have a persistent form of~     chronic multisymptom illness (CMI). GW deployed veterans are also developing significantly~     more chronic diseases such as diabetes, hypertension, arthritis, and coronary heart disease~     than their non-deployed veteran peers putting these individuals at risk for accelerated~     aging-related diseases of the peripheral and central nervous system (CNS). Recent studies~     have shown a slowing of response speed that affects mental flexibility across multiple~     cognitive domains (memory, attention, visuospatial functions) especially on tests that were~     timed and computerized and where small differences in cognitive reaction times could be~     measured. Recent studies also have suggested that the response inhibition deficits shown in~     GWV may reflect executive system dysfunction as reflected by slower motor responses across~     multiple cognitive domains.~      To date, there are no treatments that have been shown to improve the health or cognitive~     difficulties of GW veterans; thus there is an urgent need to establish effective, safe, and~     tolerable treatments for GW CMI. Previous studies in other cognitive disorders have found~     that intranasal insulin improves memory, attention, and mood, reduces neuroinflammation, and~     modulates cortisol levels; it has also been identified as a treatment that has the capacity~     to alter many of the leading problems of GW CMI.~      During this study there are 2 treatment groups and a placebo group that will last for 8~     weeks. The treatment groups will self-administer their designated dosage of insulin through a~     nasal pump twice a day, while the placebo group will administer saline through a nasal pump~     twice a day. These doses have been shown to be effective and safe. The primary outcome~     measure will assess improvements in verbal delayed memory using a specific list learning task~     and on a measure of selective attention. The study will assess improvements in overall~     physical health and mood by asking the participants to complete self report questionnaires.~     Neuroendocrine measures will also be obtained in order to evaluate changes in glucose,~     insulin, and cortisol levels and examine their impact on GW CMI.~      Intranasal insulin has shown great promise in improving memory, attention, and mood in both~     older adults with cognitive impairment as well as normal subjects. Thus, this proposal could~     prove intranasal insulin to be an effective, safe, and affordable therapy for these ailing~     veterans.~   "
134797|NCT01802931|"~     The study will determine the effect of 400 mg once daily of ketoconazole at steady state on~     the pharmacokinetics of a single oral dose of GSK239512 in young healthy volunteers.~     Ketoconazole is a strong inhibitor of CYP3A4, which is involved in metabolism of drugs. A~     two-cohort design will be applied with cohort 1 aimed at providing a first estimate of the~     interaction potential of GSK239512 and ketoconazole in terms of pharmacokinetic parameters in~     a small number of subjects. Data from Cohort 1 will inform the decision of which dose to use~     in Cohort 2, in which a larger number of subjects will be exposed to GSK239512 without and~     with ketoconazole. The target maximum exposure is aimed to be similar to the exposure by a~     single dose of 80 mcg of GSK239512 without CYP3A4 inhibition. In summary, the results from~     this study will help to estimate the maximum increase in exposure of GSK239512 during~     concomitant use of strong CYP3A4 inhibitors and will help define the subsequent dosing~     strategy around GSK239512 and co-medications with potential to inhibit CYP3A4.~   "
134798|NCT01802918|"~     GSK2838232 is a novel human immune virus (HIV) maturation inhibitor being developed for the~     treatment of chronic HIV infection. This study is the first administration of GSK2838232 in~     humans to establish the initial safety, tolerability, and pharmacokinetic profile following~     single doses of GSK2838232 and to evaluate the effect of food and ritonavir (RTV) on~     GSK2838232 in healthy subjects. There will be 2 cohorts in this study. In Cohort 1,~     approximately 8 healthy subjects will be enrolled (6 active and 2 placebo) at each dose~     visit. There will be four dosing sessions for each subject with subjects randomized to~     receive placebo in a random sequence. In Cohort 2, approximately 8 healthy subjects will be~     enrolled (6 active doses and 2 placebo doses at each dose visit). Cohort 2 will have four~     dosing sessions for each subject with subjects randomized to receive placebo in a random~     sequence.~   "
134799|NCT01802905|"~     Most systemic therapies are chosen on the basis of large randomized clinical trials; however,~     tumour heterogeneity means that cancers with similar histological features may have~     substantially different underlying biological drivers. The investigators propose that~     applying personal genomic information prospectively obtained in a clinically realistic~     timeframe to assist in chemotherapy decision-making could result in more effective and~     efficient cancer treatment. This study will investigate this approach in a cross section of~     advanced cancers to examine timeliness, deliverability, rate of actionable targets~     identified, and our ability to expand this approach into a larger clinical trial setting.~   "
134800|NCT01802892|"~     The present study aims to evaluate the impact of 5 days oral administration of ronacaleret~     100 miligram (mg) and 400 mg on changes in circulating CD34+ cells, when ronacaleret is~     followed by the administration of a single dose of plerixafor in healthy human volunteers.~      This single centre adaptive design study will be carried out in 2 parts. The part A will~     evaluate the change in peripheral circulating CD34+ cells in response to two different 5 day~     regimens of ronacaleret (100 mg or 400 mg once daily), given in conjunction with a single~     dose of plerixafor (0.24 mg/kilogram [kg]) sub-cutaneously (SC) on the evening of the final~     days dosing approximately 12 hours before collection of CD34+ cells on day 6. Subjects (5~     each) will be assigned to either one of the ronacaleret arms, in an open fashion. Comparisons~     will be made in the change from baseline to end of treatment peripheral CD34+ cell counts.~     Part A will be conducted in two cohorts with 5 subjects being enrolled into each of the 2~     treatment arms making up the first cohort. Cohort 2 will involve up to 5 further subjects~     being enrolled into each treatment arm.~      The structure of part B will be finalized following a review of data generated in part A.~      The total study duration of Part A for each subject including the screening, treatment and~     follow-up periods will be approximately 7 weeks.~   "
134801|NCT01802879|"~     The study allows continued use of single agent panobinostat in patients who are on single~     agent panobinostat treatment in a Novartis-sponsored study which has met its endpoint and are~     benefiting from the treatment as judged by the investigator.~   "
134802|NCT01802866|"~     The purpose of this study is to determine if emixustat hydrochloride (ACU-4429) reduces the~     rate of progression of geographic atrophy compared to placebo in subjects with dry~     age-related macular degeneration.~   "
134803|NCT01802853|"~     This open-label, randomized, 2-way crossover study will assess the absolute bioavailability~     and pharmacokinetics of RO6811135 in healthy male volunteers. Subjects will be randomized to~     one of the sequences AB or BA to receive single doses of subcutaneous (A) or intravenous (B)~     RO6811135, with a washout period of at least 7 days between dosing.~   "
134804|NCT01802840|"~     The aim of this study is to examine the effects of soy fiber on body weight, body composition~     and blood lipids in overweight and obese participants.~   "
134805|NCT01802827|"~     To investigate the clinical course and risk factors for VAT and the impact of VAT on~     Intensive Care Unit (ICU) morbidity and mortality.~   "
134812|NCT01802736|"~     Background: Approximately 6.4% of Ugandans are living with HIV, that is acquired and~     transmitted mainly through sexual intercourse between an HIV infected and uninfected person.~     Uganda is ranked among 28 top per capita alcohol consumers in the world and second in Africa.~     in the general population, Alcohol consumption is associated with increased sexual~     transmission risks for HIV. Data on alcohol consumption and its impact on sexual behaviors~     and HIV disease progression among HIV infected persons, the persons able to transmit HIV are~     lacking in this setting.~      Objectives: To estimate the prevalence of alcohol consumption among HIV infected persons,~     assess associations between alcohol and CD4 cell count as well as evaluate the effect of~     alcohol motivational intervention counseling on alcohol consumption and the subsequent~     practice of risky sexual behaviors, among HIV infected persons.~      Methodology: Using both cross-sectional and longitudinal methods,persons living with HIV/AIDS~     (PLWHA) attending the Infectious Diseases Institute Clinic (IDI clinic) will be recruited,~     baseline alcohol consumption evaluated, and eligible subjects reporting alcohol consumption~     will be randomized to receive either Standard positive prevention counseling alone or in~     addition to alcohol motivation intervention counseling. Sexual risk behaviors and alcohol~     consumption will be evaluated at 3 and 6 months and compared between randomization arms.~   "
134813|NCT01802723|"~     Dose Ranging Study~   "
134814|NCT01802710|"~     Functional dyspepsia (FD)is defined as the presence of symptoms thought to originate in the~     gastroduodenal region with no evidence of structural disease that is likely to explain the~     symptoms. The cause of this condition is unclear, not being a recognized treatment for it.~     The conventional treatments for those patients are symptom based. Unfortunately, these~     medications are not very effective. Patients with FD report poorer health status, mental~     health, and social functioning than patients with structural gastrointestinal pathology. Our~     aim is to compare a combined intervention (medical plus psychological intervention) versus~     conventional intervention (medical intervention)in regard to the health related quality of~     life, symptomatology, anxiety and depression of those patients. The investigators~     hypothesized that compared with conventional intervention a combined intervention would yield~     significantly better short (after treatment) and medium term (six months after treatment)~     improvement of health related quality of life and symptoms.~   "
134815|NCT01802697|"~     This is a first in man study to assess safety and tolerability of the IgG cleaving enzyme~     Immunoglobuli G degrading enzyme of streptococcus pyogenes (IdeS).~   "
134816|NCT01802684|"~     Evaluation of feasibility of adding aflibercept to an oxaliplatin-based regimen rather than a~     continuous administration of chemotherapy until progression, in order to decrease the risk of~     severe toxicities.~   "
134817|NCT01802671|"~     The objective of this study is to investigate the short- and long-term efficacy of a~     Cognitive Behavioural Treatment program for chronic low back pain supported by information~     and communication technologies~   "
134818|NCT01802658|"~     Subjects with lesion bone marrow are at risk of fracture by fragility bone. The median time~     to onset of fracture was 8.5 years. Fracture increases costs of care, dependency.~      Bone fragility is secondary to hormonal disorders and calcium phosphate, impaired excretion~     of neuropeptides, vasomotor symptoms associated with the asset that promote bone loss and~     architectural disorganization. These phenomena occur in the first weeks of development of~     spinal cord injury and predominate in the distal femur and proximal tibia. From the third~     year, the demineralization stabilizes, bone mass is estimated to be between 70 and 50% of the~     initial bone mass, the new equilibrium.~      No clinical evidence is predictive of fracture risk. A criteria surrogate must be used to~     assess this risk. There is an association between bone mineral density and fracture risk. The~     fracture threshold knee was evaluated to 0.87 g/cm2. Evaluation of bone mineral density in~     the distal femur is a predictor of fracture risk. Measure reliable and reproducible, easy to~     perform, it is a good element for monitoring the efficacy of anti-resorptive therapy.~   "
134819|NCT01802645|"~     The aim of this study is to investigate the following schedules for efficacy with regard to~     response rate in neoadjuvant treatment of patients with non-resectable liver metastases:~        -  Cetuximab/FOLFOXIRI and cetuximab/FOLFIRI in patients with ras wild type tumours and~        -  Bevacizumab/FOLFOXIRI and FOLFOXIRI in patients with ras mutant tumours.~   "
134820|NCT01802632|"~     This study will treat patients with advanced NSCLC who have already received at least one~     course of specific anti-cancer treatment but the tumour has started to re-grow following that~     treatment. This is the first time this drug has ever been tested in patients, and so it will~     help to understand what type of side effects may occur with the drug treatment, it will~     measure the levels of drug in the body, it will also measure the anti-cancer activity. By~     using these pieces of information together the best dose of this drug to use in further~     clinical trials will be selected.~   "
134821|NCT01802619|"~     Prolonged periods of cardiopulmonary bypass (CPB) cause high levels of plasma free~     haemoglobin(Hb) and are associated with increased morbidity. We hypothesized that repletion~     of nitric oxide (NO) during and after the surgical procedure on CPB may protect against~     endothelium dysfunction and organ failure caused by plasma-Hb induced NO scavenging.~   "
134822|NCT01802606|"~     The investigators conducted the study in 4 teaching hospitals and 2 non-teaching hospitals of~     Shaanxi Province. Surgeons, clinical pharmacists and nurses took part in patient collection,~     information registration, protocol performance.~      The investigators recruited 1200 patients with inguinal hernia undergoing inguinal~     hernioplasty in the six hospitals from January 2010 to July 2011. The patients were randomly~     allocated into control group, cefazolin group and levofloxacin group, with digital meter~     method , 400 in each group. The data such as age, sex, case number, length of hospital stay,~     antibiotic usage, post-operative infection, infection site, bacterial culture were filled in~     self-designed forms on computer.~   "
134823|NCT01802593|"~     The goal of the present study is to evaluate the best regimen for infliximab monotherapy, and~     to evaluate if limited combination therapy with IFX and an Immunomodulator for the first 6~     months of therapy, in prior Immunomodulator failures, is superior to monotherapy with~     Immunomodulator cessation from the second infusion, in preventing loss of remission to IFX.~   "
134824|NCT01802580|"~     To evaluate whether participation in an Internet-based intervention helps improve short-term~     and long-term psoriasis treatment outcomes, in particular, adherence.~   "
134826|NCT01802554|"~     Cardiovascular disease and depression are some of the most costly illnesses to society, and~     caring for a loved-one with Alzheimer's disease has been associated with increased risk for~     both depression and cardiovascular disease. Indeed, depressive symptoms have been linked with~     elevated plasma concentrations of D-dimer and Interleukin-6 (IL-6), both of which are~     associated with increased risk for cardiovascular disease (CVD). The present research tests a~     brief behavioral intervention for reducing both depressive symptoms and CVD biomarkers in~     Alzheimer caregivers. We hypothesize that caregivers receiving a brief Behavioral Activation~     (BA) therapy will show greater reductions in depressive symptoms and in CVD biomarkers~     relative to those randomized to a time-equivalent Information and Support (IS) therapy.~   "
134827|NCT01802541|"~     Diacylglycerol oil has been shown to lower postprandial and fasting serum triacylglycerol~     levels and reduce body fat. The investigators hypothesize that replacing dietary fat with~     diacylglycerol oil reduces excess body fat in type 2 diabetic patients and that~     diacylglycerol oil has a beneficial effect on cardiovascular risk factors in Chinese type 2~     diabetic patients.~   "
134828|NCT01802528|"~     Obturator externus (OE) muscle has the possibility as a pain generator, considering its~     anatomical and functional aspects, but this muscle as a possible target for therapeutic~     intervention is currently understudied in pain practice.~   "
134829|NCT01802515|"~     The main goal of this study is to evaluate the safety and tolerability of 40 or 80 mg~     atomoxetine as a treatment for cocaine dependence. The Phase I studies summarized above~     support the safety of atomoxetine in combination with stimulants. As the next step, the~     investigators will evaluate the safety and tolerability of atomoxetine in a small clinical~     trial with cocaine users. If atomoxetine is found to be promising in this study and~     sufficiently powered, double-blind, placebo-controlled studies will be proposed.~   "
134830|NCT01802502|"~     Tuberculous (TB) meningitis is the most severe manifestation of TB infection, leaving up to~     50% of patients dead or neurologically disabled. Current treatment is similar to treatment of~     lung TB, although penetration of some antibiotics into the brain is poor and the~     immune-pathology of TB meningitis is very different from pulmonary TB. In a recent phase II~     clinical trial from the investigators group, the first of its kind globally, intensified~     antibiotic treatment, with moxifloxacin and high dose rifampicin, strongly reduced mortality~     of TB meningitis.~      The investigators aim to examine the effect of intensified antibiotic treatment on mortality~     and morbidity of TB meningitis in a phase 3 clinical trial, preceded with an explorative~     pharmacokinetic (PK) study to examine if higher oral doses rifampicin result in exposures~     similar to the i.v. dose used in our phase 2 trial, since oral rifampicin could be~     implemented much easier in low-resource settings.~   "
134831|NCT01802489|"~     Optic neuritis (ON) is a common event in Multiple Sclerosis (MS), and causes significant loss~     of nerve cells in the eye, resulting in poor vision. Optic neuritis also provides a sensitive~     way of testing the effectiveness of drugs that may help protect from loss of nerve cells in~     ON and therefore in MS.~      The investigators have identified through laboratory and early clinical research in humans~     that amiloride (a water tablet already in use) may be a drug that can be of benefit in optic~     neuritis by protecting from loss of nerves cells, ie a neuroprotective drug.~      The purpose of this study is to assess the efficacy of amiloride as a neuroprotective drug in~     optic neuritis~   "
134832|NCT01802476|"~     The purpose of this study is to determine approximately what percentage of an orally~     administered dose of PD-0332991 is absorbed from the gastrointestinal tract into the systemic~     circulation. This approximation is made by comparing the plasma pharmacokinetics of a 125 mg~     oral dose of PD-0332991 to the plasma pharmacokinetics of a 50 mg intravenous dose of~     PD-0332991 administered as a 4-hour infusion.~   "
134833|NCT01802463|"~     Ocular blood flow has been consistently demonstrated to be altered in glaucoma patients when~     compared to otherwise healthy individuals. Numerous Doppler studies have shown a decrease in~     flow velocities in the retrobulbar arteries in what appears to be related to the degree of~     the glaucomatous disease.~      The anatomic pathway of the several arteries into the eye is intricately complicate, with at~     least one of them (the central retina artery) penetrating the optic nerve before entering the~     eye and supplying the innermost structures of the globe. As the optic nerve is surrounded by~     a layer of cerebrospinal fluid (CSF) which is in continuity with the rest of the central~     nervous system, this central retinal artery has also to cross this CSF containing~     compartment. Because of the intrinsic pressure this CSF - corresponding to the intracranial~     pressure at the orbital level - the possibility exists that this pressure around the optic~     disc could affect the blood flow of the arteries that go through it.~      The investigators will try to detect if a correlation exists between the optic nerve sheath~     diameter and the blood flow in the retrobulbar vessels of glaucoma patients.~   "
134834|NCT01802450|"~     Trial try to assess the efficacy of dasatinib in terms of major molecular response rate at 6~     months in patients with CP-CML who have achieved complete cytogenetic response without major~     molecular response after at least 18 months on Imatinib 400/600.~   "
134835|NCT01802437|"~     The purpose of the study is:~        1. to find out how long teenagers getting talk therapy (interpersonal psychotherapy) for~          depression should get therapy before the therapist decides whether or not the teenager~          is improving enough, and~        2. to compare two ways of providing treatment to teenagers who have not improved enough.~   "
134836|NCT01802424|"~     The purpose of this pilot-study is to evaluate a cognitive behavioral program, the~     Friends-program, as indicated prevention for anxious youth. The youths are recruited by~     school nurses who will also lead the intervention groups applying the Friends-manual.~   "
134837|NCT01802411|"~     The purpose of the study is to examine the safety and efficacy of liposome bupivacaine for~     intercostal nerve block in subjects undergoing posterolateral thoracotomy.~   "
134847|NCT01802281|"~     The primary purpose of this randomized clinical trial is to compare the effectiveness and~     safety of two transvaginal apical suspension strategies for uterovaginal prolapse: a mesh~     augmented hysteropexy versus vaginal hysterectomy and uterosacral ligament suspension (USLS).~     The primary aim is to determine whether treatment success in women who undergo the above~     strategies differ at time points through 3 years.~      A supplemental study investigates anterior vaginal wall movement resulting from descent or~     rotation of the vaginal apex and/or anterior vaginal elongation, in women in both of the~     study arms of SUPeR.~   "
134838|NCT01802398|"~     Syncope (temporary loss of consciousness) is a frequent reason for an emergency department~     (ED) visit among older adults. The current ED evaluation of syncope frequently leads to~     hospitalization, results in low diagnostic yield, and is enormously costly. The purpose of~     this protocol is to improve risk prediction for syncope. Improved risk prediction will inform~     the design of interventions to safely reduce unnecessary health service use.~      This is a multi-center, prospective, observational cohort study of older (age≥60 years)~     adults who present to an emergency department with syncope (otherwise known as fainting). The~     primary outcome is a composite of 30-day cardiac death and serious cardiac events.~      Study Aims and Hypotheses are:~      Specific Aim 1. Describe serious outcomes after unexplained syncope; rates and reasons for~     admission; and frequency, diagnostic yield, and therapeutic impact of inpatient diagnostic~     tests.~      H1: Current patterns of care representing a diversity of practice settings and patient~     populations are costly with low clinical benefit.~      Specific Aim 2. Derive and validate a novel risk prediction model for 30-day cardiac death~     and serious cardiac outcomes after unexplained syncope.~      H2: Explicit criteria including contemporary cardiac biomarkers will improve risk~     stratification compared to unstructured physician assessment and published risk models.~      Specific Aim 3. Assess safety and costs of a risk-tailored diagnostic algorithm compared to~     existing care for unexplained syncope.~      H3: A risk-tailored diagnostic algorithm can safely reduce the costs of evaluating~     unexplained syncope in older adults.~   "
134839|NCT01802385|"~     This is a phase III trial to determine whether adjunctive sertraline will lead to improved~     survival 18-week survival.~      There was an initial phase I/II unmasked dose finding pharmacokinetic study of CSF~     concentrations in 172 persons conducted from August 2013 to August 2014.~   "
134840|NCT01802372|"~     The goal of this study is to evaluate the comparative effectiveness of the World Health~     Organization Package targeted at Cardiovascular (CV) risk assessment and hypertension~     control, delivered by Community Health Nurses as part of Ghana's Community based Health~     Planning and Services program, versus provision of health insurance coverage, on blood~     pressure reduction. Findings from this study will provide policy makers and other~     stakeholders needed information to recommend efficient cost-effective policy with regards to~     comprehensive CV risk reduction in patients with hypertension in low resource settings.~   "
134841|NCT01802359|"~     The purpose of this study is to evaluate the safety and effectiveness of mirodenafil in~     participants with erectile dysfunction.~   "
134842|NCT01802346|"~     This randomized phase II trial studies how well a controlled low calorie diet works in~     reducing side effects and increasing response to chemotherapy in patients with breast or~     prostate cancer. Drugs used in chemotherapy work in different ways to stop the growth of~     cancer cells, either by killing the cells or by stopping them from dividing. Eating a special~     diet with low calories may reduce the side effects of chemotherapy and improve the response~     to treatment~   "
134843|NCT01802333|"~     This randomized phase III trial studies cytarabine and daunorubicin hydrochloride or~     idarubicin and cytarabine with or without vorinostat to see how well they work in treating~     younger patients with previously untreated acute myeloid leukemia. Drugs used in~     chemotherapy, such as cytarabine, daunorubicin hydrochloride, idarubicin, and vorinostat,~     work in different ways to stop the growth of cancer cells, either by killing the cells,~     stopping them from dividing, or by stopping from spreading. Giving more than one drug~     (combination chemotherapy) and giving the drugs in different doses and in different~     combinations may kill more cancer cells. It is not yet known which combination chemotherapy~     is more effective in treating acute myeloid leukemia.~   "
134844|NCT01802320|"~     This phase II trial studies how well v-akt murine thymoma viral oncogene homolog 1 (Akt)~     inhibitor MK2206 works in treating patients with previously treated colon or rectal cancer~     that has spread from the primary site to other places in the body or nearby tissue or lymph~     nodes and cannot be removed by surgery. Akt inhibitor MK2206 may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth.~   "
134845|NCT01802307|"~     Prostate cancer is the most common solid organ cancer among men and is the second leading~     cause of cancer death. In 2013 about 238,590 men will be diagnosed with prostate cancer and~     29,720 men will die of the cancer. Overall, about 1 in 6 men will be diagnosed with prostate~     cancer in their lifetime, but only 1 in 36 men will die. Currently, there are over 2.5~     million men in the US living with prostate cancer. Standard treatment for prostate cancer has~     involved either removal of the prostate (radical prostatectomy) or application of some type~     of energy to the entire prostate gland in order to kill all of the cells--usually with~     radiation or cryotherapy (freezing).~      Over the past decade, it has become apparent that while some men will benefit from treatment~     for prostate cancer, many will not. Particularly for men with a small amount of low-grade~     (not very aggressive) type of prostate cancer, the risk of death from this very slow-growing~     cancer is very low. However, the risk of harm from some of the treatments for prostate cancer~     is very high. Treatment for prostate cancer can cause erectile dysfunction, urinary leakage,~     difficulty urinating and overactive bladder and bowel symptoms.~      One strategy for men with low risk prostate cancer has been to avoid immediate treatment and~     wait until the cancer starts to grow. The risk of this strategy is that some men may not be~     able to be cured once the cancer starts to grow. In addition, men who are on this active~     surveillance protocol can become very nervous, fearing that the cancer will start to spread.~      A new strategy to avoid some of the treatment harms of prostate cancer while also attempting~     to avoid allowing the cancer to grow is called focal therapy. Many men with low-risk prostate~     cancer will have only a small piece of cancer within the prostate gland. These men may~     benefit from treating only this one area instead of the entire prostate. This will allow the~     physician to kill the cancer cells and to avoid some of the problems associated with treating~     the entire prostate.~      The purpose of this study is to investigate the use of focal, targeted treatment of prostate~     cancer, that is, to treat only the small area of cancer instead of the entire prostate. We~     hope to show that this strategy will reduce the amount of side effects without compromising~     cancer cure.~   "
134846|NCT01802294|"~     This pilot feasibility trial will evaluate the Sinovuyo Caring Families Program in a~     small-scale randomized controlled trial in Cape Town, South Africa (n=60 families). The pilot~     study will use a mixed-methods approach to intervention evaluation. Self-report and observed~     quantitative data for intervention and control groups will be collected at pre-test and~     post-test evaluation. Primary outcomes will include parent-reports and observations of child~     behavior problems. In addition, as an exploratory study, this phase will examine initial~     pre-post intervention effects for potential mediating factors of parenting behavior, parental~     stress, parental depression, and perceived social support. However, this phase will not test~     mediation effects due to small sample sizes. Quantitative assessments will also collect data~     on program fidelity, exposure/adherence, participant engagement, and satisfaction.~     Furthermore, qualitative focus groups with intervention participants and group leaders will~     examine issues of program feasibility, content, deliver, and satisfaction. Randomization will~     be done on an individual level and include a wait-list control group that will receive the~     intervention 3 months after the post-test evaluation. Results from the feasibility pilot~     study will be shared with intervention partners and advisory groups. If necessary, final~     program adjustments will be made prior to further testing. Results will also be disseminated~     to community forums, local organizations, government stakeholders, and via academic~     conferences.~      Research hypotheses:~      Hypothesis 1: Children in the intervention group will demonstrate reduced observed and~     parent-reported child behavior problems in comparison to the control group.~      Hypothesis 2: Parents in the intervention group will demonstrate increased observed and~     self-reported positive parenting outcomes and decreased observed and self-reported harsh and~     inconsistent parenting outcomes in comparison to the control group.~      Hypothesis 3: Parents in the intervention group will demonstrate decreased parental~     depression and parental stress outcomes and increased perceived social support outcomes in~     comparison to the control group.~      Hypothesis 4: The Sinovuyo Caring Families Program will be implemented with an acceptable~     degree of program fidelity, exposure/adherence, and participant satisfaction.~   "
134848|NCT01802268|"~     Background Early conversion from calcineurin inhibitor to mammalian target of rapamycin~     inhibitor is one of the immunosuppressive strategies that have been investigated to mitigate~     long-term CNi associated adverse events. This study aims to evaluate the conversion from~     tacrolimus to sirolimus in de novo kidney transplant recipients.~      This multicenter, open-label study, planned to enroll 297 patients initially treated with~     tacrolimus, enteric-coated mycophenolate sodium (1440 mg/day, orally) and prednisone. The~     primary objective is to show superior glomerular filtration rate in the SRL group at 24~     months after transplantation.~   "
134849|NCT01802255|"~     Patients needing intensive care often require sedative drugs to reduce anxiety and agitation~     during ventilator care and invasive therapeutic and diagnostic procedures. At present there~     is no optimal sedative agent for these patients. The most commonly used sedative agents in~     intensive care units are midazolam and propofol. Both drugs have side effects of clinical~     importance.~      At present, a viable alternative to intravenous sedation is inhalatory sedation. Sevoflurane,~     as other inhaled anesthetic agents, is sedative in low doses. A new simplified method of~     administration of isoflurane or sevoflurane has been developed. The Anesthetic Conserving~     Device is a modified heat-moisture exchanger (HME) that permits direct infusion of~     sevoflurane to the airway, where it is vaporized in an evaporator rod in the device.~      However, the use of sevoflurane is limited to anesthesia and sedation lasting no more than 12~     hours, since the possible renal problems posed by inorganic fluoride in prolonged operations~     remain the subject of controversy.~      The primary aim (and primary hypothesis) of the current trial is to determine whether~     sevoflurane can be administered as a sedative drug for more than 48 hours without clinically~     relevant physiopathological effects on kidney and liver function.~      Other end-points of the trial are to evaluate the quality of sedation of sevoflurane, in~     terms of sedation control, the rapidity and predictability of awakening, and the incidence of~     delirium in critical care patients.~   "
134850|NCT01802242|"~     Prostate cancer is common in males and may develop over the course of an individual's life.~     This cancer is often discovered at the time of routine physical examinations and/or blood~     work or on rectal examination. Once diagnosed, most patients do require some form of~     treatment so that the prostate cancer does not progress to cause damage and/or shortened~     lifespan. Occasionally, after patients receive treatment, the investigators have found that~     an area of cancer remains within the prostate. Those patients with a large area of cancer~     (i.e. seen on MRI image) appear to have a higher chance of remaining or recurrent prostate~     cancer even after standard treatment. Thus, the investigators believe that the area of the~     prostate gland occupied by a dense area of cancer may need more radiation therapy than normal~     to remain cancer free.~      Standard therapy currently in place in North America: Currently patients who are diagnosed~     with prostate cancer have 3 common options: surgery, external beam radiation therapy (EBRT)~     alone or internal radiation (brachytherapy). Patients may or may not receive hormone therapy~     alongside the radiation depending on their physician's preference. For those who receive~     radiation therapy, the tumor typically receives the same dose as the rest of the prostate~     gland.~      Findings to date: In the past few years the investigators have discovered that patients with~     a tumor large enough to be seen on MRI images (>5mm) have a higher chance than normal of~     having cancer remain in the prostate, despite receiving treatment for their cancer 3 years~     earlier. Using new technology investigators can deliver radiation therapy after viewing the~     prostate tumor on MRI. This guides therapy, allowing the radiation treatment to be targeted~     to the tumor within the prostate. Based on this earlier success the investigators believe~     that they can now safely give a higher dose of radiation to specifically target the cancer~     within the prostate gland.~      Reason for the study: The investigators would like to test this technology and expertise to~     give radiation to a higher than normal dose to the tumor nodule in prostate gland.~   "
134851|NCT01802229|"~     The incidence of port-site hernia in patients with risk factors (obesity, elderly, diabetes~     and lung disorders) can be reduced by the use of a prophylactic mesh in the closure of~     umbilical port site.~   "
134852|NCT01802216|"~     The purpose of this study is (1) to determine whether a 12-month trial of patients from~     underserved communities with clinically significant gum disease and kidney disease randomly~     assigned to intensive gum disease treatment or delayed treatment is feasible and (2) to~     determine the variability of various tests of kidney function and inflammation in response to~     intensive gum disease treatment.~   "
134853|NCT01802203|"~     To collect efficacy and outcomes data related to the use of trūFreeze® spray cryotherapy for~     the treatment of unwanted tissue in the pulmonary and gastrointestinal settings.~   "
134854|NCT01802190|"~     The study will allow to identify the prevalence of the SLC17A8 gene mutations in patients~     suffering from deafness. This phenotype also corresponds to DFNA15 deafness caused by POU4F3~     : mutations of this gene will be screened as well.~   "
134855|NCT01802177|"~     Alopecia Areata (AA) is a chronic autoimmune inflammatory disease causing nonscarring hair~     loss. Many treatment modalities have been found to be helpful in AA, however, none on them~     cure the disease. UVB excimer light has recently emerged as a new therapeutic modality in~     many dermatologic diseases. There are no prospective randomized controlled trials evaluating~     the efficacy and safety of UVB excimer light in AA. We plan on conducting a prospective split~     lesion single-blinded randomized clinical trial to assess efficacy and safety of UVB excimer~     light in the treatment of AA.~   "
134856|NCT01802164|"~     In patients undergoing laparotomy, the incidence of abdominal wall related complications such~     as incisional hernia is very high. In particular in patients with peritonitis undergoing~     laparotomy the incidence of incisional hernia is up to 54.3%. Furthermore, these patients are~     at great risk for development of postoperative fascial dehiscence.~      The gold standard of abdominal wall closure is a running slowly absorbable suture~     irrespective of the presence of peritonitis. Implantation of an intraperitoneal mesh~     potentially reduces the incidence of incisional hernia.~      In a series of high risk patients in which we implanted non-absorbable intraperitoneal mesh~     prophylactically we reduced the incidence of incisional hernia down to 3.2%.~   "
134857|NCT01802151|"~     The purpose of this study is to evaluate the effect of three doses of the probiotic B.~     subtilis (Bacillus subtilis R0179) delivered in capsules on gastrointestinal and general~     wellness in healthy young adults, survival through the gastrointestinal tract and impact on~     intestinal microbes.~   "
134858|NCT01802138|"~     Activated T cell were manufactured through in vitro T cell expansion of autologous T cell. We~     designed this study to determine the feasibility and safety of Activated T-lymphocyte cell~     therapy for refractory/relapsed neuroblastoma patients.~   "
134859|NCT01802125|"~     This clinical trial studies biomarker differences in samples from patients with~     undifferentiated sarcomas. Studying biomarker in tissue samples from patients with cancer in~     the laboratory may help doctors identify and learn more about biomarkers related to cancer~   "
134860|NCT01802112|"~     The purpose of this study is to assess the efficacy of resistant maltodextrins, compared to~     placebo, in reducing the colonic transit time in healthy subjects.~   "
134862|NCT01802086|"~     The aim of this intervention study is to compare the efficacy of Emla cream as a pain relief~     or no pain relief in connection to the first pneumococcal vaccination at the age of three~     months in Child health care.~      Primary objective~      1.Leads Emla cream as pain relief to children in connection with pneumococcal vaccination at~     the age of three months to lower pain scores in the use of FLACC as a pain measurement~     instrument?~   "
134863|NCT01802073|"~     Determine the benefit of oral vancomycin therapy for Primary Sclerosing Cholangitis.~   "
134864|NCT01802060|"~     This study will examine the performance of the Persona assays in identifying the time when~     risk of pregnancy is highest by comparing results to ultrasound observed ovulation and other~     indices of ovulation.~   "
134865|NCT01802047|"~     Initiating and sustaining breastfeeding are common challenges in neonatal units.~      It is known that hindmilk expressed at the end of the expression session has a higher fat~     content.~      Previous studies have shown that simultaneous pumping is more effective at producing milk~     than sequential pumping. However this approach is often felt uncomfortable by the mothers,~     and sequential pumping is preferred.~      The purpose of this study is to determine which modality of milk expression by electric pump~     is the most efficient and productive when sequential pumping is used.This is done by~     assessing the milk volume expressed per expression and its macronutrients content.~   "
134866|NCT01802034|"~     A central goal of this data repository is to collect data from a large population of subjects~     with a variety of renal disease states. Cohorts will include subjects with diabetes,~     inflammatory/autoimmune and transplant related renal conditions. Additionally, the repository~     will have the capacity to store biospecimens and electronic data in control subjects without~     established renal disease. This initiative will provide an opportunity to compare data from~     various disease states and controls with the objective of determining clinical and biological~     factors that predict disease progression, response to therapy and identify discriminating~     noninvasive clinical and biological features that predict renal biopsy findings.~   "
134867|NCT01802021|"~     The myeloid-derived suppressor cells (MDSCs) can further trigger cytotoxic T cell apoptosis,~     and may shift the macrophages toward M2 subtype, inhibit the Th1 cell, and initiate other~     immune suppressive mechanism. The functions of NK cells and regulatory T cells are altered,~     resulting in a disturbance of anti-tumor immune function. All these can further create an~     environment with a benefit for malignant cell growth and advancement. Astragalus-based~     formula may confer its survival advantage in cancer patients through modulating the immune~     system and reversing the immunosuppressive microenvironment.~      The investigators aim to study the role of Qingshu-Yiqi-Tang in reversing the immune~     alterations in patients with advanced stage, non-small cell lung cancer who receive 1st line~     doublet chemotherapy of cisplatin plus doxetaxel（or Pemetrexed for adenocarcinoma）and 2nd~     line target therapy of erlotinib. The investigators can explore the possible mechanism of the~     Astragalus-based formula: Qingshu-Yiqi-Tang in modulating and reversing immunosuppression in~     advanced stage, non-small cell lung cancer patients.~   "
134868|NCT01802008|"~     The objective of this study is to determine the optimal withdrawal time for colonoscopy. A~     6-minute withdrawal time is currently the standard of care but has only been evaluated in an~     observational fashion. The investigators believe that this should be validated in a~     standardized fashion. If the benefits of a 6 minute withdrawal are proven in this study (ie a~     low polyp/adenoma miss rate and a high polyp/adenoma detection rate), then this will support~     widespread adoption of a 6 minute withdrawal as the standard of care. This in turn may~     decrease the occurence of 'interval colon cancers', which are early colon cancers arising in~     subjects despite their having undergone colonoscopy. Our hypothesis is that the polyp/adenoma~     detection rate will be unacceptably low and the polyp/adenoma miss rate will be unacceptably~     high in the 3-minute withdrawal group when compared to the 6-minute withdrawal group.~   "
134869|NCT01801982|"~     This single center study will monitor the developmental progress of PPHN patients who~     received iv sildenafil in study A1481276. Two visits will be conducted, at 12 and 24 months~     following the end of study drug infusion.~   "
134870|NCT01801969|"~     The proportion of patients who return to work after surviving severe traumatic brain injury~     (TBI) has been estimated in number of studies but results do not agree.This may be due to~     complex interaction between many factors, including available rehabilitation services.~      In Denmark rehabilitation services vary been regions and municipalities. Hospital based~     rehabilitation is organized by the regions. Rehabilitation outside the hospitals is organized~     by the municipalities~      The first purpose of this study is to investigate a possible link between centralized~     hospital based rehabilitation and better return to work / quality of life.~      The second purpose is to investigate whether municipality size affects quality of life and~     return to work after severe TBI.~      Data on return to work are derived from a national register on labor market attachment. Data~     on quality of life are derived from a questionnaire.~      The study population is identified from the Danish Head Trauma Database. The completeness and~     accuracy of the database will be investigated as the first part of the project.~   "
134871|NCT01801956|"~     Background: Low levels of cardiorespiratory fitness are associated with high risk of~     non-communicable diseases and all-cause mortality. Physical activity level is the primary~     determinant of cardiorespiratory fitness in adults. However, knowledge on how to motivate~     people to engage in physical activity and maintain an active lifestyle is lacking. This study~     aims to investigate whether a motivational, individual, and locally anchored exercise~     intervention, in primary care, can improve cardiorespiratory fitness in 30 to 49 year olds~     with a low or very low cardiorespiratory fitness.~      Design: Randomised controlled trial with 6 and 12 months follow-up. The primary outcome is~     cardiorespiratory fitness. Secondary outcomes include biochemical parameters (HbA1C, HDL- and~     LDL-cholesterol, and triglyceride), physical activity level (measured by accelerometer),~     self-reported physical activity, anthropometric parameters and health-related quality of~     life.~      Methods: Cardiorespiratory fitness will be estimated via a maximal incremental exercise test~     and expressed as the index of maximum oxygen uptake per minute divided by body weight (ml~     O2/kg/min). A total of 236 participants, classified with a very low or low cardiorespiratory~     fitness at a local health check programme, (corresponding to ≤ 39 and ≤35 ml O2/kg/min. for~     30-39 and 40-49 year-old men respectively and ≤33 and ≤31 ml O2/kg/min. for 30-39 and 40-49~     year-old women respectively), will be randomised into two groups. The intervention group will~     receive 4 motivational interviews, six months membership to a sport club, and a global~     positioning watch to upload training activity to a social media. The comparison group will~     receive standard care: a one hour motivational interview. In addition to an~     Intention-to-treat analysis a per-protocol analysis will be performed. Effect of the~     intervention will be estimated by evaluating the differences in mean changes in~     cardiorespiratory fitness between the two groups.~      Discussion:In new and innovative ways the focus of this study will be to improve~     cardiorespiratory fitness among a 30-49 year-old at-risk group using social media,~     GPS-technology, on-going personal support and individually tailored physical activity.~   "
134880|NCT01801839|"~     The imbalance between anti- and pro-inflammation often occurs in patients with sepsis. And~     continuous such imbalance could lead to immunoparalysis, which is characterized by loss of~     delayed type hypersensitivity, failure of primary infections eradication, and a~     predisposition of secondary nosocomial infections development. However, in which phase of~     sepsis does immunoparalysis occur is still unknown. So this study aims to tentatively~     understand this problem by checking monocytes/macrophages` antigen presentation and cytokine~     secretion，and by checking monocytes/macrophages` expression of Tim-3 (the T cell~     transmembrane, immunoglobulin, and mucin-3), which is an inhibitory regulatory molecule, in~     sepsis patients` peripheral blood mononuclear cells.~   "
134881|NCT01801826|"~     myoscience Inc. (Redwood City, CA) has developed a device for a novel, minimally invasive~     facial rejuvenation procedure designed to soften hyperdynamic facial lines. The myoscience~     Cryo-Touch IV device uses well-established principles of cryobiology to cause localized~     reduction in muscle activity resulting in a reversible reduction in facial animation and the~     appearance of facial lines. The device operates on well-established cryobiology principles;~     that localized exposure to controlled low temperature conditions can alter tissue function.~     The therapy treats targeted motor nerves with low temperatures via a cold probe in the form~     of an assembly of small diameter needles, creating a highly localized treatment zone around~     the probe. The thermal algorithm is designed to produce a reversible loss of nerve conduction~     resulting in a temporary decrease in muscle contractility. Prior studies of Cryo-Touch,~     Cryo-Touch II and Cryo-Touch III have provided strong evidence of effectiveness and safety~     for applications in this indication. The goal of the study described herein is to show the~     safety and effectiveness of this approach using the Cryo-Touch IV device.~   "
134882|NCT01801813|"~     Patients undergoing a brain tumour neurosurgery with craniotomy may present rare but~     lifethreatening post-operative complications. There are currently no strong recommendations~     to help the clinician in an attempt to properly hospitalise these patients after their~     intervention (Neuro-ICU, ICU,surgical ward).~      Determining risk factors of post-operative complications could optimise resources. Therefore~     hospitalisation in Neuro-ICU would be mandatory in only a little number of patients.~   "
134883|NCT01801800|"~     Cardiac dysfunction can occur in aneurysmal subarachnoid haemorrhage and might impact~     patient's neurologic outcome Condition Aneurysmal subarachnoid haemorrhage World Neurosurgeon~     Federation Score ≥ III~   "
134884|NCT01801787|"~     The current study investigates the basic principles that underlie the efficacy of~     transcranial direct current stimulation for chronic auditory verbal hallucinations in~     schizophrenia in a multimodal design.~   "
134885|NCT01801774|"~     Phacoemulsification is a quick method with less complication for cataract surgery. Due to the~     use of ultrasonic energy, it produced more post-operative inflammation than other methods.~     Many routes of steroid had been used to control post-operative inflammation. The~     investigators here compare the efficacy of single depot steroid subtenon injection (20-mg~     triamcinolone) with four-time-a-day steroid eye drop (0.1% dexamethasone) in controlling~     inflammation after uneventful phacoemulsification.~   "
134886|NCT01801761|"~     To detect the existence of severe obstructive sleep apnea (OSA) in chronic obstructive~     pulmonary disease (COPD) patients, which had higher mortality and hospitalization rate, a~     simplified questionnaire was developed for identifying those COPD patients with severe OSA.~   "
134887|NCT01801748|"~     Wheat allergy is affected 0.4-1% and is a major staple of the worldwide diet. Wheat avoidance~     is exceedingly difficult and imposes major dietary restriction. The purpose of this study~     were to determine the rate of oral tolerance and identify clinical and laboratory predictors~     of tolerance development in Thai children who allergic to wheat.~   "
134888|NCT01801735|"~     The purpose of this study is to evaluate the safety of Meloxicam SoluMatrix Capsules for up~     to 52 weeks in subjects with pain due to osteoarthritis (OA) of the knee or hip~   "
134889|NCT01801722|"~     The aim of the present study was to evaluate if the analysis of NT-proBNP might be used as an~     initial step for the diagnosis of chronic heart failure in patients with COPD in primary~     health care, and to select patients for a further examination by echocardiography.~   "
134890|NCT01801709|"~     The objective of this open-label, single arm, monocentric, phase I/II clinical study is to~     assess safety and efficacy of ARSA gene transfer in the brain of children affected with early~     onset forms of Metachromatic Leukodystrophy (MLD). For this purpose, an adeno-associated~     virus serotype rh.10 (AAVrh.10) vector will be used to transfer the ARSA cDNA coding for~     Arylsulfatase A (ARSA) enzyme into the brain of children. Five patients with early onset form~     of MLD, age ranging from 6 months to 4 years, will be included in this protocol and will be~     followed during 24 months.~      Patients will be selected at presymptomatic or early stage of their disease, following~     clinical, neuropsychological and brain imaging criteria.~      Twelve simultaneous injections of the investigational medicinal product will be performed in~     the white matter of both brain hemispheres, through 6 image-guided tracks, with 2 deposits~     per track.~      A low dose (1x10EXP12 vg total) will be administered to the first 2 patients, while the last~     3 will receive a higher dose (4x10EXP12 vg total).~      Safety and efficiency will be evaluated based on clinical, neuropsychological, radiological,~     electrophysiological and biological parameters.~   "
134891|NCT01801696|"~     Through funding from the U.S. Maternal and Child Health Bureau, Teaching Research Institute~     at Western Oregon University (WOU) will be conducting research on the effect of a~     parent-delivered massage program on measures of autism and general development in young~     children with autism. Families will participate in an initial training, and receive 24~     sessions of ongoing support and training from a trained therapist over the first nine months.~   "
134892|NCT01801683|"~     Evidence-based medicine (EBM) is the basis of work for physicians- practitioners in all~     specialties, including family medicine. Various issues in diagnosis, treatment and prognosis~     appear in daily work with patients and a physician should provide answers based on the best~     evidence stemming from research. In spite of having access to EBM databases in every GP's~     office in Croatia, searching and finding answers in consultation with a patienton the spot~     in real time is missing from practice.~      OBJECTIVES: To determine GP's knowledge and attitudes about EBM before and after applying~     modified academic detailing EBM intervention. provided by sixth- year medical students We~     assume that GP's knowledge and attitudes about EBM will change as a result of EBM~     intervention applied by students.~   "
134893|NCT01801670|"~     Mycosis Fungoides (MF) is a rare malignancy in the United States. It is the most common form~     of cutaneous T-cell lymphoma (CTCL). Sézary syndrome (SS) is the most severe and leukemic~     form of CTCL. Pruritus, or itch, is defined as an unpleasant sensation that elicits the~     desire to scratch. Severe itch is a manifestation of all forms of MF, especially those with~     patch/plaque and folliculotropic variants, as well as in Sezary patients. While severe itch~     causes great suffering for patients, the pathogenesis of itch in MF and Sezary syndrome is~     complex and not well understood. It is thought that various chemical mediators are produced~     by the malignant cells to cause itch. Vorinostat, an FDA approved therapy for the treatment~     of MF, has also been reported to relieve pruritis. The goal of the study is to evaluate how~     vorinostat affects different chemicals in the skin that have been known to cause itch. This~     is a single center, non-randomized study designed to obtain and test blood and skin tissue~     samples take at various time-points over 6 months in patients who are prescribed vorinostat~     per standard of care treatment. Samples from pruritic and non-pruritic skin and blood of MF~     and Sezary patients will be evaluated for the presence of chemicals thought to be important~     in the cause of itch in these diseases. This evaluation will include immunohistochemistry,~     RT-PCR, and ELISA assays. The results from this study may help define how vorinostat~     decreases itch in patients with MF and Sezary Syndrome.~   "
134894|NCT01801657|"~     Bronchiectasis is clinically characterized by irreversible dilation of the bronchi and~     bronchioles leading to persistent cough, purulent sputum, and airway ﬂow limitation, which~     may be accompanied by recurrent exacerbations.It has been increasingly recognized that~     respiratory viruses are mainly responsible for acute exacerbation of chronic pulmonary~     diseases, i.e. asthma, chronic obstructive pulmonary disease and cystic fibrosis.~     However,little is known about the roles of viral infection in driving exacerbations of~     bronchiectasis.This study aims to identify the frequency of common viral infections and~     determine the roles that viruses play in acute exacerbations of bronchiectasis.~   "
134895|NCT01801644|"~     To evaluate the efficacy and safety of neoadjuvant gemcitabine and cisplatin (gem/cis) in~     locally advanced bladder cancer.~   "
134896|NCT01801631|"~     Background: In type 2 diabetes mellitus patients, an acute coronary event (ACE) may result in~     a decreased quality of life and increased distress. According to the American Diabetes~     Association, transition from the acute care setting is a high-risk time for all patients, but~     tailored support specific to diabetes is scarce in that period. The investigators developed~     an intervention by a diabetes nurse to help diabetic patients reduce distress after their~     first ACE. The intervention is based on Bandura's Social Cognitive Theory, Leventhal's Common~     Sense Model, and on results of focus groups which were conducted to define the needs and~     wishes of type 2 diabetes patients and their partners regarding professional support after an~     ACE. The aim of this study is to evaluate the effectiveness of the intervention to reduce~     distress. The hypothesis is that patients who receive the intervention will have less~     diabetes related distress compared to the control group.~      Methods/Design: Randomized controlled trial. Patients will be recruited directly after~     discharge from hospital. A diabetes nurse will visit the patients in the intervention group~     (n = 100) within three weeks after discharge from hospital, two weeks later and two months~     later. The control group (n = 100) will receive a telephone consultation. The primary outcome~     is diabetes related distress, measured with the Problem Areas in Diabetes questionnaire~     (PAID). Secondary outcomes are quality of life, anxiety, depression, HbA1c, blood pressure~     and lipids. Mediating variables are self-management, self-efficacy and illness~     representations. Variables will be measured with questionnaires directly after discharge from~     hospital and five months later. Biomedical variables will be obtained from the records from~     the primary care physician and the hospital. Differences between groups in change over time~     will be analyzed according to the intention-to-treat principle.~      Discussion: Type 2 diabetes patients who experience a first ACE need tailored support after~     discharge from the hospital. This trial will provide evidence of the effectiveness of a~     supportive intervention to reduce distress in these patients.~   "
134897|NCT01801618|"~     Medium and long term efficacy of PI-based 2nd line antiretroviral (ARV) therapy in Cambodia~     is poorly documented when the numbers of patients on treatment and their duration are~     increasing. For patients in treatment failure , there is no alternative ARV regimen available~     to date.~      This operational research aims to evaluate the Cambodian National Program PI-based 2nd line~     antiretroviral regimen to assess the proportion of treatment failure and drug resistance~     ;identify the structural and individual factors associated with treatment failure ; design~     alternative salvage ARV regimens.~   "
134898|NCT01801605|"~     The purpose of this study is to evaluate the efficacy of Repetitive Transcranial Magnetic~     Stimulation (rTMS) on rectal hypersensitivity in patients with irritable bowel syndrome (IBS)~     in a prospective, randomized, double-blind study.~   "
134899|NCT01801592|"~     The main aim of this study is to determine how common undiagnosed obstructive sleep apnoea is~     in individuals with intermittent claudication.~   "
134900|NCT01801579|"~     Hemodynamic changes in the lower limbs are very important and rapid after maximal exercise.~     The automatic method allows a fastest measurement of the Ankle-Brachial Index (ABI). Thus, it~     appears important to know whether automatic assessment of ABI is as reliable and reproducible~     as the manual method.~   "
134901|NCT01801566|"~     This study aims to evaluate the treatment with single implant overdenture for the edentulous~     mandible. The investigators hypothesize that treatment with lower overdenture retained by a~     single implant appears to have satisfactory effectiveness as a treatment for patients with~     specific conditions (such as maladaptive patients), with the advantages of simplicity and~     greater immediate benefits when compared to the conventional full denture, improving the~     retention and stability of the denture and better oral-related quality of life.~   "
134902|NCT01801553|"~     The purpose of this study is:~      - To validate or not the interest of the classification using the pragmatic application of~     clinical predictive rule for low back pain to identify patients with good prognosis following~     a brief spinal manipulation intervention.~      Patients (n = 100 to 150) :~      Recruited from emergency department of Saint-Luc hospital by medical doctors~      Inclusion criteria:~      A. Non-specific (No red flags) acute low back with mobility deficit (limitation in bending)~     and a pain duration < 16 days and no symptoms distal to the knees, male and female patients~     aged 19-55 years.~      Exclusion criteria:~        -  Specific LBP (red flags) and radiating beyond the knee~        -  Low Back Pain Non-specific subacute and chronic~        -  Recurrent low back pain (more than 3 painful episodes)~        -  Lumbar instability or hyper laxity (instability catch, active straight leg raise (SLR) >~          90°, aberrant movement,range of motion (ROM) of le lower lumbar spine > 50° during~          standing flexion), pregnancy and post-partum status~        -  High irritability = necessity of opioid medication or intravenous injection of~          medication in the emergency department~        -  previous history of surgical intervention in the low back area~      Intervention:~      - 3 sessions within one week of spinal manipulation (thrusts, grade V)~      comparison:~      - 3 sessions of false/sham manipulation (placebo) in side lying on thoraco-lumbar hinge in a~     grade II~      Co-intervention similar in both group:~      = traditional medical care (TMC)~      - Reassure patients, avoid bed rest, advise them to stay active and to take analgesics (if~     needed such as paracetamol) (European Guidelines for non-specific acute low back pain ; van~     Tulder et al. 2006 ; Koes et al. 2010).~      Outcomes:~      Use of effect sizes by standardized mean of difference. ANOVA one and Two Way, number needed~     to treat (NNT) analysis and intention to treat analysis on all outcome variables:~        -  Primary: Kinematic Variables: two indices, logit score for the amplitude and velocity~          (Hidalgo et al., 2012) and patient's expectation from manual therapy (MT) treatment to~          improve his LBP~        -  Secondary: Pain in the presentation with visual analogical scale (VAS) and the~          repartition (body diagram), Oswestry Disability Index (ODI, questionnaire on pain and~          function), patient specific function (PSF), fear avoidance beliefs questionnaire (FABQ),~          Start back tool, physical examination, medication use, return to work and treatment side~          effects, patient's belief in a real MT intervention or not (at the end of the follow-up)~      Study design:~        -  Double blind ie: patients and assessors blind.~        -  The methodological quality of the study is the 8-9/10 on the PEDro scale, we will~          strictly follow the CONSORT statement and will be register in clinical.trials gov~      Evaluators:~      Christine Detrembleur (PT-PhD-UCL), Maxime Gilliaux (PT-PhD-student-UCL)~      Responsible for the study: Henri Nielens (MD-PhD-UCL)~      Practitioner and investigator:~      Benjamin Hidalgo PE, PT-MT, DO, PhD-student Certificate in Orthopedic Manual Therapy (Manual~     Concepts, Curtin University) Assistant-Professor Faculty of Physical therapy (FSM-UCL)~     Belgium~      International collaborator:~      Timothy Flynn (PT-PhD), Regis University, Denver, USA~   "
134903|NCT01801540|"~     The purpose of this study is to investigate the effect of a meal containing different doses~     of L-arabinose, on the intestinal sucrase activity after intake We measure this by measuring~     the glucose, insulin and c-peptide after meals. Other measurements are made (glucagon and~     GLP-1) to explain the correlations.~   "
134904|NCT01801527|"~     Background: Cancer is increasingly viewed as a chronic disease and therefore there is a~     growing need for long-term treatments. Breast cancer survivors suffer physical impairment~     after oncology treatment. This impairment reduces quality of life (QoL) and increases the~     prevalence of conditions associated to unhealthy life-style.~      Objective: The overall objective of e-Cuidate telerehabilitation will be to evaluate short~     and long-term effects telehealth program.~      Methods: Seventy-two breast cancer survivors (age range: 18-65 years) will be recruited~     through oncology and breast units at the Virgen de las Nieves Hospital and San Cecilio~     Hospital and associations of breast cancer patients in Granada. Patients will be randomized~     to receive the online rehabilitation group (n=36) or usual care (control) group (n=36).~     Telerehabilitation group will receive an eight-week online intervention and control group~     receive recommendations about usual care.~      Discussion: The investigators study attempts to increase the level of fitness and reduce~     musculoskeletal disorders in breast cancer patients through a strategy for care based on~     telerehabilitation to promote therapeutic exercise.~   "
134908|NCT01801475|"~     This is called Aim 1 of the investigators' NIH grant. Ondansetron (Zofran) is a safe and~     effective drug used in pregnant women to prevent nausea but the investigators do not know~     what effect pregnancy may have on the metabolism of Zofran in pregnant women or their babies.~     Therefore the investigators will enroll approximately 40 pregnant women and their babies and~     draw blood samples from the mother, the baby and the cord, to determine how much Zofran is in~     each sample of blood (called the pharmacokinetics or PK of Zofran). The pregnant women will~     receive Zofran, as a standard-of-care drug, for their scheduled Cesarean Section.~      The investigators will also enroll about 20 non-pregnant women undergoing surgery who will~     receive Zofran as standard-of-care during surgery. In both the pregnant & the non-pregnant~     women, the investigators will draw blood samples at the same time points based on number of~     minutes from the time the Zofran is given. The blood data (PK of Zofran) will help the~     investigators move into Aim 2 of the study, which will be done in pregnant, narcotic-addicted~     mothers and their babies who are born addicted to narcotics. Aim 2 will be listed separately~     as it will be an interventional study.~   "
134909|NCT01801462|"~     Ultrasonography has become increasingly used in many medical specialties over the last~     decades as smaller and less expensive ultrasound equipment has become available. Although~     ultrasound imaging traditionally is considered safe, its use is highly operator dependent~     (EFSUMB 2010). The lack of sufficient operator skills can lead to diagnostic errors that~     eventually compromise patient safety due to unnecessary tests or interventions (Moore & Copel~     2011). A recent report from the British National Health Service (NHS) analyzed maternity~     claims reported to the NHS over the past decade and identified antenatal fetal ultrasound~     investigations as one of the four major risk areas in obstetric care (NHS 2012). This study~     therefore aims to explore the effects of simulation-based ultrasound training on patient~     comfort levels and the need for re-examination by a second physician due to diagnostic~     uncertainty.~   "
134910|NCT01801449|"~     Background:~      - Deficiency of the IL-1 receptor antagonist (DIRA) is a condition that causes repeated~     episodes of inflammation. People with DIRA can have rashes, fever, and joint pain. Most~     treatments for DIRA are intended to control the immune system to stop these inflammations.~     There are drugs that can treat DIRA, but they have to be given daily as injections.~     Researchers want to try another drug, rilonacept, as a treatment for DIRA. It needs to be~     given only once a week. Rilonacept will be given to individuals who are at least 3 months old~     and who have DIRA.~      Objectives:~      - To test the safety and effectiveness of rilonacept for children and adults with DIRA.~      Eligibility:~      - Individuals at least 3 months old who have DIRA.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Other tests to study pain and movement will be given. Imaging~          studies such as bone density scans and x-rays may also be taken.~        -  Participants will have a minimum of four to five study visits over 12 months. Those who~          are on different anti-inflammatory drugs (such as anakinra) will stop taking them before~          beginning the study visits.~        -  Participants will have rilonacept injections weekly while on this study. The dose will~          be adjusted as needed to help treat the DIRA symptoms. Participants will keep a diary to~          monitor their symptoms and any side effects.~        -  Treatment with rilonacept will be given for 1 year. Participants will have study visits~          to monitor the treatment. They will provide blood samples and have other tests at these~          study visits.~   "
134911|NCT01801436|"~     The purpose of this post marketing study is to determine the plasma concentration of~     bortezomib (unchanged drug) to assess the pharmacokinetic (PK - the study of the way a drug~     enters and leaves the blood and tissues over time) properties in the Taiwanese population. It~     will also provide expanded access (expanded access, sometimes called compassionate use, is~     the use of an investigational drug outside of a clinical trial to treat a participant with a~     serious or immediately life-threatening disease or condition who has no comparable or~     satisfactory alternative treatment options) to bortezomib for the same group of participants~     with multiple myeloma (cancer of the types of cells normally found in bone marrow).~   "
134912|NCT01801423|"~     Given large absolute numbers of individuals with sickle cell disease in Nigeria, hydroxyurea~     therapy for all individuals with sickle cell disease may not be initially feasible; however,~     a targeted strategy of hydroxyurea use for primary prevention of strokes is an alternative to~     the standard therapy (observation) for high-risk individuals. The investigators propose a~     feasibility study, Sickle Cell Disease - Stroke Prevention in Nigeria (SPIN) Trial, to~     determine whether hydroxyurea can be used for primary prevention of strokes in Nigerian~     children with sickle cell anemia.~   "
134913|NCT01801410|"~     Between 40,000 and 80,000 pregnant women die annually from pre-eclampsia and eclampsia.~     Magnesium sulphate and anti-hypertensive therapies can reduce the morbidity associated with~     pre-eclampsia. The only cure, however, comes with delivery. Prompt delivery of the baby,~     preferably by vaginal route, is vital in order to achieve good maternal and neonatal~     outcomes. Induction of labour is therefore a critical intervention in order to prevent~     morbidity to both mother and baby. Two low cost interventions - oral misoprostol tablets and~     transcervical Foley catheterization - are already used by some in low resource settings, but~     their relative risks and benefits are not known. These interventions could optimize the care~     pathway for women needing induction of labour. This is especially important in low resource~     settings where improvement is most needed and the potential to reduce the maternal and~     neonatal mortality and morbidity is the greatest. The ideal induction agent would result in a~     relatively short induction to delivery interval without risk to fetus and with low rates of~     emergency caesarean section. The induction to delivery interval is especially important in~     pre-eclampsia and eclampsia where the condition may deteriorate rapidly until delivery.~     Inductions with prostaglandins, including misoprostol, are sometimes associated with uterine~     hyperstimulation and consequent fetal hypoxia, whilst the effectiveness and safety of Foley~     catheter as an induction agent has been persistently questioned. This study will identify the~     risk, benefits and trade-offs in efficacy, safety, acceptability and cost of these two low~     cost induction methods.~   "
134914|NCT01801397|"~     Study Title:~      A pilot study to evaluate the effect of Forsteo® (Teriparatide, 1-34 rh-PTH) in Anorexia~     Nervosa patients with low mineral density and increased bone fragility (FAN-Trial)~      Short Title/Study ID:~      FAN-Trial / Psy-Rheu_2011/1~      Indication:~      Low bone mineral density (Z-Score < -1.5 or T-Score < -1.5 if available) and fragility~     fractures or very low bone mineral density (Z-Score < -2.5 or T-Score <-2.5 if available)~     without fragility fractures in Anorexia Nervosa patients~      Trial Design:~      Open-label, single-centre pilot study with study drug treatment duration of 24 months.~      Study Center:~      Single-centre (University Hospital of Zürich)~      Investigator(s)/Authors:~      PD Dr. med Gabriella F. Milos (Principle Investigator and author), Dept of Psychiatry, Centre~     for Eating Disorders, University Hospital Zürich, CH-8091 Zürich Dr. med. Diana P. Frey~     (Co-Investigator and author), Dept. of Rheumatology, University Hospital Zürich, CH-8091~     Zürich PD Dr. med. Daniel Uebelhart (author), SUVA Fribourg, CH-1701 Fribourg~      Objective(s)/Outcome(s):~      Primary endpoint:~      •To assess the efficacy of Teriparatide (Forsteo®) in increasing the bone mineral density in~     the lumbar spine, total hip and femoral neck in patients with anorexia nervosa and low bone~     density at months 12 and 24.~      Secondary endpoints:~        -  To assess the changes in blood biomarkers~        -  To assess changes in whole body composition~        -  To assess the incidence of new fragility fractures~        -  To assess changes in bone structure~        -  To assess the changes in EDE-Q~        -  Longterm safety and tolerability of Teriparatide (Forsteo®) in patients with AN~      Assessments for primary endpoint:~      •BMD at lumbar spine, total hip and femoral neck, measured by DXA~      Assessments for secondary endpoints:~        -  bone resorption and bone formation markers measured in urine and serum~        -  whole body composition measured by DXA~        -  New clinical peripheral and vertebral fractures~        -  HRqCT of tibia and forearm~        -  EDE-Q Score at months 12 and 24~      Safety measurements:~        -  Safety lab (blood and urine)~        -  Clinical adverse event monitoring at all visits Number of Subjects: 10~      Diagnosis and Main Inclusion Criteria:~        -  Women, aged > 18 to < 35 years~        -  Having severe anorexia nervosa (AN) (DSM-IV-R) for > 12 months before screening~        -  Presenting with very low bone mineral density (defined as Z-Score < -2.5 or T-Score <~          -2.5 if available) of at least one of the assessed localizations (lumbar spine L1 - L4,~          total hip, femoral neck) without any previous fragility fracture~        -  or low bone mineral density (defined as Z-Score < -1.5 or T-Score < -1.5 if available)~          of at least one of the assessed localizations (lumbar spine L1 - L4, total hip, femoral~          neck) and at least one previous fragility fracture~        -  In- and out-patients of the Centre for Eating Disorders at the Clinic for Psychiatry and~          Psychotherapy of the University Hospital of Zurich.~      Main Exclusion Criteria:~        -  Metabolic bone diseases other than primary osteoporosis (including hyperparathyroidism,~          osteomalacia, Paget's disease of bone), pre-existing hypercalcemia, severe renal~          impairment (GFR < 30 ml/min), prior external beam or implant radiation therapy to the~          skeleton, skeletal malignancies or bone metastases, any unknown elevation of serum~          alkaline phosphatase, severe psychiatric diseases other than AN, drug addiction, HIV~          positive patients, pregnancy, open epiphyses~        -  Incapacity to understand the aims of the study or patients not willing to collaborate.~      Study Product, Dose, Route, Regimen:~      Teriparatide (Forsteo®), 20µg s.c. daily for 24 months.~      Duration of study:~      24 months.~      Reference therapy, Dose, Route, Regimen:~        -  Trial with medicinal product~   "
134915|NCT01801384|"~     The major goal of this project is to examine the efficacy of a voucher-based incentive~     program for promoting smoking cessation (Study 1) and preventing relapse (Study 2) during~     pregnancy and postpartum. Identifying efficacious interventions to increase cessation rates~     and decrease relapse among those who are able to quit is important to improving U.S. public~     health.~   "
134916|NCT01801371|"~     This is an open-label brain PET/CT (positron emission tomography/computed tomography) study~     to investigate the diagnostic performance and evaluation efficacy of 68Ga-BNOTA-PRGD2 in~     glioma patients. A single dose of nearly 111 MBq 68Ga-BNOTA-PRGD2 (≤40 µg BNOTA-PRGD2) will~     be intravenously injected into patients in suspicion of glioma. Visual and semiquantitative~     method will be used to assess the PET/CT images. Brain MRI with/without enhancement and~     18F-FDG PET/CT will be performed for comparison. The postoperative pathology and integrin~     αvβ3 and CD34 immunohistochemical stains will also be used for correlation.~   "
134917|NCT01801358|"~     A phase Ib dose-escalation study of the AEB071 and MEK162 combination in adult patients with~     confirmed metastatic uveal melanoma. Cohorts of 3-6 patients will be assessed for dose~     limiting toxicities (DLTs) during Cycle 1 until the maximum tolerated dose (MTD) of the~     combination therapy is determined. The MTD or Phase 2 Recommended Dose (P2RD) will be used in~     a Phase II part of the study, which will enrol 55 patients each into two randomized groups:~     the combination therapy or MEK162 alone. The Phase II part will continue until proof of~     concept is established. Patients will continue treatment as long as clinical benefit is seen~     and no limiting adverse toxicity is observed~   "
134918|NCT01801345|"~     The primary aim of this randomized controlled trial is to examine the effect of fatigue on~     clinical performance in a simulated obstetric emergency. This scenario was chosen because it~     is a common clinical situation faced by anesthesia providers on call and therefore likely to~     occur when a provider is fatigued. Secondary outcomes will include the evaluation of other~     factors that worsen fatigue related decrement in performance including age, years of~     training/practice and clinical load prior to study participation.~   "
134919|NCT01801332|"~     To evaluate the effect of an intensive enteral nutrition (compared to clinical routine) in~     association with corticosteroïds in patients with severe acute alcoholic hepatitis.~   "
134920|NCT01801319|"~     This is a randomized, placebo-controlled double-blind cross-over trial evaluating the safety,~     efficacy, daily functioning, and health-related quality of life of Subcallosal Cingulate~     Gyrus Deep Brain Stimulation (SCG DBS) for participants with Treatment-Resistant Depression~     (TRD). A total of 40 eligible participants will be randomized to four treatment sequences (10~     participants per sequence). Each participant will be treated over a 6-month period with~     active or sham stimulation in which both the participants and the attending psychiatrists~     will be blinded to treatment allocation.~   "
134921|NCT01801306|"~     To assess the feasibility of a new brain tissue probe for multi-parameter neuromonitoring~     (NeMo Probe) and the accuracy of measurement values.~      To demonstrate the ability of the NeMo probe to detect changes in cerebral hemodynamics and~     oxygenation during cerebrovascular events monitored with established methods including brain~     tissue oxygenation tension and microdialysis~   "
134922|NCT01801293|"~     This is a single center, open-label, Phase 1 study to determine the mass balance of of~     GS-5806 following administration of a single, oral dose of radiolabeled [14C]-GS-5806 in~     healthy subjects.~   "
134923|NCT01801280|"~     The objective of this pharmacokinetic study is to examine a possible drug-drug interaction of~     Pantoprazole on the bioavailability mycophenolic acid administered as either Mycophenolate~     mofetil (Cellcept(R) or Mycophenolate Sodium; EC-MPS (Myfortic (R) in stable renal allograft~     recipients under maintenance immunosuppressive therapy (cyclosporine +/- low dose~     glucocorticoids).~   "
134924|NCT01801267|"~     Ventriculoperitoneal shunts are the standard of care for patients with communicating~     hydrocephalus, but they have a high failure rate - up to 40% fail within 1 year and 50% fail~     within 2 years. It has long been assumed that endoscopic third ventriculostomy (ETV) would~     not work in this population and is better suited to patients with obstructive hydrocephalus~     (such as from a tumor blocking cerebral-spinal fluid (CSF) pathways). However, as scientists~     learn more about CSF and the way our brains absorb this fluid, they have learned that this~     may not be so straight-forward. Recent small studies have shown that ETVs can work in a good~     percentage of children with communicating hydrocephalus, too. But no randomized controlled~     trials have been done to compare these two treatments directly to determine which will~     provide children with a better prognosis, fewer surgeries over their lifetime, less time in~     the hospital and the greatest chance at as normal a life as possible.~      The investigators will conduct a trial to compare these two surgical treatments where~     patients will be randomized to receive either a shunt or an ETV. Because ETV has been shown~     to have a high failure rate in newborns, the investigators will not include these patients~     and instead will study patients who come to Duke University with communicating hydrocephalus~     between the ages of 1 year and 18 years. The study will include patients with ventricular~     shunts who are in need of revision and patients who were just diagnosed and need their first~     shunt.~      All patients who agree to participate will be randomized to receive either an ETV or a shunt.~     The study team will follow them for one year from the time of the surgery and will determine~     what percentage of patients require further CSF-related surgeries, how long they go after~     their surgery before they need another surgery, how much time they spend in the hospital and~     what percentage of patients suffer CSF-infections or other problems related to the surgery or~     their hydrocephalus. The study team will examine these results and determine if ETV is a~     safer or more effective treatment for children with communicating hydrocephalus than is a~     ventricular shunt.~   "
134925|NCT01801254|"~     The field of neuroeconomics has begun to elucidate neural mechanisms underlying self-control;~     however, researchers have not yet harnessed neuroeconomics findings to develop interventions~     for improving self-control ability. The investigators are currently developing such an~     intervention. The investigators' approach involves using a brain-computer interface with~     audiovisual feedback to show people what is happening in their own brains, in real time.~     Through this interface, individuals are trained to increase levels of neural activity that~     may facilitate self-control, which, in turn, may improve the ability to exhibit~     self-controlled behaviors. This may increase the ability to engage in heath behaviors for~     which self-control is required (eg, dieting and exercising). The investigators' long-term~     goal is to create a tool that will help people develop the self-control needed to achieve~     lasting improvements in health behaviors.~   "
134926|NCT01801228|"~     This study compares Spironolactone, a non-selective aldosterone antagonist, with Eplerenone,~     a selective aldosterone antagonist, regarding efficacy and hormonal side effects when~     treating male cirrhotic patients with uncomplicated ascites over a 6 month period. The~     investigators hypothesis is that Eplerenone is as effective as Spironolactone as treatment of~     ascites with less side effects such as painful gynecomastia.~   "
134927|NCT01801202|"~     -  The study will re-confirm that the LightSheer Duet HS 805 nm handpiece is safe for~          removal of unwanted hair, and will result in hair removal and permanent hair count~          reduction.~        -  Twenty (20)subjects, Fitzpatrick Skin Type I-IV will be included in a single site.~        -  Each subject will receive five treatments at four to six week intervals and return for~          follow-up visits at three and six months after the last treatment for evaluation of the~          treated areas.~   "
134934|NCT01801111|"~     This open-label, non-randomized, multicenter phase I/II study will evaluate the safety and~     efficacy of RO5424802 in patients with non-small cell lung cancer who have ALK mutation and~     failed crizotinib treatment. In Part 1, cohorts of patients will receive escalating doses of~     RO5424802 orally twice daily. In Part 2, patients will receive the recommended phase II dose~     of RO5424802 as determined in Part 1. Treatment will continue in Part 1 and Part 2 on the~     same dose until disease progression. In Part 3, following disease progression, patients~     without EGFR mutation will be offered continued treatment with RO5424802, patients with EGFR~     mutations will be offered a combination of RO5424802 and Tarceva (erlotinib).~   "
134935|NCT01801098|"~     The development of a high grade AV-block is a frequent complication associated with~     transcatheter aortic valve implantation (TAVI). Patients who were suitable for TAVI will be~     enrolled in this study. The HV-interval will be determined before and immediately after~     implantation.~      The hypothesis is that a prolonged HV-interval is associated with a high rate of complete~     AV-block following TAVI.~   "
134936|NCT01801085|"~     This is a prospective time-and-motion study to document and compare the time used in~     preparation, dispensing and administration for capecitabine/oxaliplatin (XELOX) versus IV~     5-FU/leucovorin/oxaliplatin (FOLFOX4) regimens in colorectal cancer (CRC) patients.~   "
134937|NCT01801072|"~     After a thorough review of the existing literature as well as a review of our own practice,~     the investigators have concluded that the decision to treat patients undergoing aneurysm~     repair with levetiracetam has reached true clinical equipoise. In other words, the~     investigators cannot favor a decision to either administer or not administer this drug in~     these patients based on the existing information. The utility of anti-epileptic prophlaxis in~     the perioperative period for patients undergoing intracranial aneurysm repair remains a~     common practice that is not supported by the current literature that includes retrospective~     analyses as well as prospective trials for similar but not identical types of patients. The~     investigators propose to settle this dilemma by performing a prospective randomized trial in~     patients undergoing aneurysm repair in order to definitively determine if the common practice~     of perioperative antiepileptic drug administration has any utility.~   "
134938|NCT01801059|"~     This randomized clinical trial focused on activating the patient to ask their health care~     provider for a colorectal cancer screening test to improve screening rates for colorectal~     cancer. The patient activation intervention may increase information seeking, number of~     screening tests ordered and number of completed screening tests for colorectal cancer.~   "
134939|NCT01801046|"~     This phase I trial studies the side effects of donor stem cell transplant in treating~     patients with high risk acute myeloid leukemia. Giving low doses of chemotherapy before a~     donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may~     also stop the patient's immune system from rejecting the donor's stem cells when they do not~     exactly match the patient's blood. The donated stem cells may replace the patient's immune~     cells and help destroy any remaining cancer cells (graft-versus-tumor effect)~   "
134940|NCT01801033|"~     Background:~      - Hypothyroidism is a condition caused by the loss of function of the thyroid gland. The~     thyroid gland produces two hormones, T4 and T3. These hormones control the metabolism and~     function of many organs. Lack of energy, depression, and constipation are common symptoms of~     hypothyroidism. T4 is converted into T3, the active form of thyroid hormone, by two enzymes~     called deiodinases. People with hypothyroidism are treated with a synthetic T4 hormone, which~     the enzymes convert to T3. This treatment is usually effective, but some people continue to~     have symptoms even after treatment. Some researchers think that this may be caused by a~     problem with the enzymes that convert T4 into T3. They want to look at how the enzymes~     regulate the levels of T4 and T3 in the blood. They will do so by using a drug that blocks~     the action of one of the two enzymes.~      Objectives:~      - To look at how thyroid hormone enzyme blocking affects hypothyroidism treatment medication.~      Eligibility:~      - Individuals at least 18 years of age who have hypothyroidism and are on thyroid hormone~     replacement therapy.~      Design:~        -  The study consists of one screening visit, 9 days of inpatient hospital admission, and a~          follow-up visit 2 weeks after discharge.~        -  Participants will be screened with a physical exam and medical history. They will~          provide blood samples.~        -  Participants will receive balanced-diet meals to take home for the 2 days before they~          enter the hospital. They will continue this diet while in the hospital.~        -  During the inpatient stay, participants will be monitored with regular blood tests. They~          will have the following procedures:~        -  Continued thyroid hormone replacement for all 9 days.~        -  Drug to block thyroid enzyme for 7 days.~        -  Metabolism test, with room temperature changes, on days 1, 2, 5, 8, and 9.~        -  Measurements of body fat on days 2, 5, and 8.~        -  Blood glucose tests on days 1 and 9.~        -  Muscle contraction tests on days 1, 2, 4, 5, 8, and 9.~        -  Heart imaging studies on days 2, 5, and 8.~        -  Optional skeletal muscle and fat tissue biopsies on days 1 and 9.~        -  There will be a follow-up visit 2 weeks after leaving the hospital. Participants will~          have a final physical exam and provide blood samples.~   "
134941|NCT01801020|"~     Introduction: Temperature measurement is a crucial and integral element in the assessment of~     the emergency department patients. The basis of triage and treatment is often directly~     influenced by temperature measurement. The finding of hyper/hypothermia may differentiate~     between a simple urinary tract infection and pyelonephritis, or in more extreme cases may~     discern weakness in the elderly from sepsis. This brief encounter of temperature~     measurement may be paramount to the medical treatment of the emergency department patient.~     The investigators will explore the different modes of temperature measurements in emergency~     department patients.~   "
134942|NCT01801007|"~     The purpose of this study is to evaluate the safety and effectiveness of the MicroVention~     Flow Redirection Intraluminal Device (FRED) system when used in the treatment of wide-necked~     intracranial aneurysms.~   "
134943|NCT01800994|"~     ASTHMA:~      Asthma is a chronic inflammatory disorder of the airways in which many different types of~     cells, and various cellular components. The chronic inflammation causes an increase of the~     over-responsiveness of the airways, which leads to recurrent episodes of wheezing,~     breathlessness, chest tightness, and coughing, particularly at night or in the early morning~     hours. These episodes, usually associated with widespread but variable block the airway,~     which is usually reversible either spontaneously or by treatment.~      Asthma is one of the most common chronic diseases worldwide, posing significant social burden~     in both children and adults. It is estimated that about 300 million people currently suffer~     from asthma. The incidence of asthma is universal regardless of the level of development of~     the country. There is evidence that over the last 20 years the prevalence has increased~     significantly, specially in pediatric populations.~      COPD:~      Chronic Obstructive Pulmonary Disease (COPD) is a major public health problem. It is the~     fourth leading cause of chronic morbidity and mortality in the United States after heart~     disease, strokes and acute respiratory infections, while on an annual basis, the disease robs~     the lives of more than 3,000,000 people around us worldwide. The most worrying is that the~     impact has been steadily rising, and this dramatic increase in the frequency shows that by~     2020 the disease will be the third leading cause of death. In Greece, 8.4% of the population~     suffers from COPD.~      Smoking is the leading cause of COPD. However, not all smokers develop the clinical picture~     of COPD, suggesting that additional factors are involved in manifestation. Further~     investigation of risk factors for COPD, methods of reducing exposure to these agents and the~     molecular and cellular mechanisms involved in the pathogenesis remain a major area of~     research to develop effective treatments that will reduce or prevent the development the~     disease.~   "
135016|NCT01800045|"~     Double blind, randomized, parallel groups study of Pitolisant versus placebo, in narcoleptic~     patients experiencing EDS, and cataplexy (minimum of 3 complete or partial cataplexy attacks~     per week).~      The patients will be treated during 7 weeks with Pitolisant or placebo.~   "
134944|NCT01800981|"~     Once the victim survived the acute phase, the outcome of wound healing, the scarring, became~     a major medical issue with complications that may lead to cosmetic and functional sequelae.~     Scar tissue is clinically distinguished from normal skin by an aberrant color, rough surface~     texture, increased thickness (hypertrophy), contraction, firmness and sometimes, decrease~     function.~      Thus, functional and cosmetic outcomes became at least important as wound closure in~     assessing wound healing products~   "
134945|NCT01800968|"~     The primary objective is to test the hypothesis that, compared with placebo, therapy with~     Subcutaneous (SQ) GLP-1 agonist in the post-Acute Heart Failure Syndrome (AHFS) discharge~     period will be associated with greater clinical stability at six months as assessed by a~     composite clinical endpoint.~   "
134946|NCT01800955|"~     It is a double-blind randomized sham-controlled clinical trial to evaluate the effectiveness~     of resistive capacitive diathermy in subjects affected by knee osteoarthritis in comparison~     with a sham diathermy treatment. The resistive capacitive diathermy is a medical device~     supplying low (448 KHz) radiofrequencies with maximum output power of 200 W, used to reduce~     pain and inflammation and allowing healing processes. The sham diathermy treatment is~     administered with the device set on on but not active (not supplying energy). Each subject,~     randomly assigned to either resistive capacitive diathermy treatment (group 1) or~     sham-treatment (group 2) is submitted to a thirty minutes session, three times per week for a~     total of ten sessions. The outcome measures are the WOMAC scale (Western Ontario and McMaster~     Universities Arthritis Index) to assess pain and physical functioning, a visual analogic~     scale (VAS) for pain, the femoral quadriceps strength (MRC = Medical Research Council Scale).~     Outcome measures are administered at baseline (T0), at the end of the treatment protocol~     (T1), at 1 month (T2) and 3 months (T3) after the end of treatment.~   "
134947|NCT01800942|"~     The last decade has witnessed an important reduction of the mortality in children under 5~     years but such reduction has not impacted in neonates. Mortality in neonates contributes 40%~     of all deaths occurring in children below 5 years of age.~      Severe bacterial disease is among the leading causes of neonatal deaths. Bacterial disease~     follows bacterial infection. Individuals can be infected without developing disease (carriage~     stage) but infection is needed to subsequently develop disease. In sub-Saharan Africa,~     bacterial carriage (i.e. in the birth canal and/or nasopharyngeal tract) is very common in~     all age groups, with the consequence that occurrence of bacterial disease is one of the~     highest in the world.~      Newborns can be infected during labour - when passing through the birth canal - and during~     the first days/weeks of life, as a consequence of the close physical contact with the mother,~     if the latter carries bacteria in the nasopharyngeal tract.~      If the mother is an important source of bacterial infection to the newborn, treating mothers~     with a powerful antibiotic during labour should decrease bacterial carriage and therefore~     diminish the risk of bacterial transmission to the newborn during the first days/weeks of~     life, which should in turn result in the lower occurrence of severe bacterial disease and~     hence lower mortality.~      The purpose of this trial is to evaluate the impact of a single oral dose of azithromycin~     given to women in labour on bacterial carriage of the newborn as well as the women during the~     first month after delivery.~      The investigators have selected an antibiotic (azithromycin) that in sub-Saharan Africa has~     already shown both a strong impact on bacterial nasopharyngeal carriage and on all-cause~     mortality when administered to everybody in a community (mass drug administration). This~     specific antibiotic has several advantages for being deployable as a simple intervention in~     rural Africa, i.e. it requires a single oral administration, it has no special storage~     requirements and it has the potential to eliminate many of the bacteria commonly causing~     severe disease in newborn.~      This clinical trial will be conducted in a peri-urban health facility in Western Gambia. If~     an impact is shown, the next step would be to conduct a larger study aiming at establishing~     if the intervention, implemented at a lower level of care (most African women deliver at home~     assisted by traditional birth assistants), decreases the occurrence of neonatal bacterial~     disease~   "
134948|NCT01800929|"~     The purpose of this study is to evaluate the performance and usability of the N6 system in~     children with the N5 system.~   "
134949|NCT01800916|"~     The aim of the the current investigation is to develop new soft and more flexible 1-piece~     ostomy products.~   "
134950|NCT01800903|"~     The aim of the study is to evaluate safety and performance of a new catheter coating,compared~     to the current SpeediCath coating.~   "
134951|NCT01800890|"~     The aim of the current clinical investigation is to evaluate the performance and safety of~     new 2-piece ostomy product concepts.~   "
134952|NCT01800877|"~     The purpose of this research study is to determine if it is better to give vasopressors to~     patients to maintain a higher blood pressure target versus a lower blood pressure target.~     This study is important because the information we find out will help us know how best to~     administer vasopressors in patients with shock in the ICU.~   "
134953|NCT01800864|"~     Leptin is a fat hormone which acts in maintaining energy balance. However, leptin levels are~     high in obese subjects indicating resistance to the actions of leptin. High leptin levels~     have been associated with increased cardiovascular and metabolic risks, but it is not clear~     if increased leptin or leptin resistance contributes to the increased cardiovascular risk.~     Further, even though leptin receptors are present in fat tissue, leptin's role in fat tissue~     functions are not completely investigated in humans. Based on preliminary data the~     investigators hypothesize that resistance to leptin action in obese adipose tissue is~     responsible for altering the expression of adipose tissue proteins which contribute to the~     development of cardiovascular and metabolic dysfunction. To test this hypothesis the~     investigators propose a novel study directed at investigating the leptin dependent changes in~     adipose tissue protein expression using adipose tissue obtained from lean and obese human~     subjects~   "
134954|NCT01800851|"~     Weight gain is a common complication after transplantation. It has adverse effects such as~     hypertension, dyslipidemia, and insulin resistance. Weight gain is implicated in the~     increased cardiovascular risk and the long-term loss of graft function. Weight loss achieved~     by a suitable dietary intervention in these patients transplanted kidney can correct lipid~     disorders and facilitate balance blood pressure. The identification of mechanisms responsible~     for weight gain would suggest prevention strategies and allow to align the caloric energy~     needs of renal transplant patients.~   "
134955|NCT01800838|"~     This phase I trial studies the side effects and best dose of silicon phthalocyanine 4 and~     photodynamic therapy in treating patients with stage IA-IIA cutaneous T-cell non-Hodgkin~     lymphoma. Photodynamic therapy (PDT) uses a drug, silicon phthalocyanine 4, that becomes~     active when it is exposed to a certain kind of light. When the drug is active, cancer cells~     are killed. This may be effective against cutaneous T-cell non-Hodgkin lymphoma.~      Funding Source - FDA OOPD~   "
134956|NCT01800825|"~     Preterm birth has been linked to certain types of vaginal infections. The goal of this study~     is to determine if giving women pregnant between 13-20 weeks with an elavated vaginal~     pH(evidence of this type of infection)Oral Clindamycin(an antibiotic)will have a lower rate~     of preterm birth compared to women given a placebo(starch)~   "
134957|NCT01800812|"~     Methods Patients received OM-174 twice weekly for a total of 5, 10 or 15 injections of either~     600, 800 or 1000 µg/m². Pharmacokinetic analysis and cytokine dosages were performed. Natural~     Killer cells activity and toll-like receptors 4 polymorphism analysis were also performed.~   "
134958|NCT01800799|"~     This study will enroll 30 female patients with the first time urinary tract infection (UTI),~     30 female patients with recurrent UTI and 10 female without any prior history of UTI or~     urinary tract pathology will be invited to serve as the controls. Urine samples will be~     collected in the patients at baseline, 7 days after antibiotics treatment, and 2 weeks, 4~     weeks, 8 weeks, and 12 weeks. Urinalysis will be performed at each visit and urine culture~     will be performed at baseline and at the 2 weeks and 3 months visits. Urine samples at~     baseline and 3 months will be collected from the controls for comparison.~   "
134959|NCT01800786|"~     The overarching goal of the research proposed here is to test the hypothesis (i) that the~     pathophysiological mechanisms of OSA lead to deterioration in sleep-dependent memory~     consolidation across memory systems, with the genetic marker APOε4 as a modulator, and (ii)~     that CPAP can reverse some or all of these measured memory deficits.~      In addition, we are exploring which aspects of OSA (e.g., changes in sleep architecture,~     measures of hypoxemia, or the EEG power spectrum) most likely impact sleep-dependent memory~     processing.To this end, we are using specific cognitive tasks for which sleep-dependent~     memory consolidation processes have previously been demonstrated by our group and others. In~     addition, we are carrying out quantitative EEG power spectral analyses, to delineate abnormal~     functioning of brain regions with more precision.~   "
134960|NCT01800773|"~     Although evidence-based treatments for PTSD exist, a significant minority of individuals do~     not benefit from these treatments and many individuals to not seek treatment, citing barriers~     such as time commitment and expense of treatment. The goal of the proposed study is to~     establish an alternative PTSD treatment that is efficacious and efficient.~   "
134961|NCT01800760|"~     The purpose of the study is explore the effect of probiotics on plasma lipopolysaccharides~     (LPS) concentrations, as well as insulin and glucose levels, in obese women prior to and~     after dietary challenges (high carbohydrate meal, high fat meal).~   "
134962|NCT01800747|"~     The general hypothesis is that delayed antibiotic treatment strategy present similar~     effectiveness, when compared with non-prescription of antibiotics or the prescription of~     antibiotics, in the non-complicated acute respiratory tract infections in pediatric patients.~   "
134963|NCT01800734|"~     Physiology studies will be performed in patients with type 1 diabetes to define during a~     standardized mixed meal test: 1. The relationship between fast insulin analogue~     administration by i.v. infusion or by subcutaneous pumps and plasma insulin concentration and~     tissue insulin action; 2. The relationship between insulin action, glucose fluxes and glucose~     concentration, the latter one as measured in plasma or estimated by a s.c. glucose-sensor; 3.~     The concentration curves of some potential modifiers of the glucose-insulin system (i.e.:~     glucagon, incretin hormones, free fatty and amino acids).~      On the basis of these data, in silico phenocopies of the patients (virtual patients) will be~     created to measure the glucose control coefficients, which quantify the role played by each~     component of the glucose-insulin system on glucose concentration.~      One final purpose of this research is to develop and to optimize an algorithm able to~     integrate continuous glucose monitoring with continuous subcutaneous fast insulin analogue~     infusion, known as closed-loop control (CLC) or artificial pancreas.~   "
134964|NCT01800721|"~     The present study includes a randomized clinical trial of a peer health education~     intervention and a 12-month longitudinal study. The sample will include Black Men who have~     Sex with Men (MSM) who will be randomized into an experimental or control condition and then~     asked to recruit peer and risk network members for HIV testing over a 3 month period. Some of~     the network members who are recruited for voluntary counseling and testing (VCT) will enroll~     into the longitudinal study for assessments only. Both index and network participants will be~     assessed at baseline, 6, and 12-months.~      The specific aims of the proposed study are to:~        1. Train Black MSM (index participants in the experimental condition) to conduct peer~          health education, to promote VCT and HIV risk reduction among social network members,~          and to recruit social network members for VCT.~        2. Examine changes in HIV risk behaviors and VCT among index participants and their network~          members in the experimental intervention as compared to those in the control condition.~        3. Examine mediating effects of social environments (networks, social norms) on HIV risk~          behaviors and VCT, among indexes and network members.~        4. Examine mediating effects of individual level factors (substance use and depression) on~          HIV risk behaviors and VCT among indexes and network members.~   "
134965|NCT01800708|"~     The aim of the present study is to investigate the outcomes of congenital cataract surgery~     when injecting intraoperative intracameral triamcinolone versus the postoperative use of oral~     prednisolone.~      This is a prospective, randomized clinical trial. Sixty children will be submitted to~     congenital cataract surgery younger than 2 years of age. They will be randomly divided in two~     groups. The study group will receive an intraoperative intracameral triamcinolone acetonide~     injection. The control group will receive prednisolone syrup postoperatively. The surgical~     outcomes will be assessed after one year.~   "
134966|NCT01800695|"~     This study is evaluating the safety and pharmacokinetics of ABT-414 in subjects with~     glioblastoma multiforme.~   "
134967|NCT01800682|"~     The purpose of this study is to evaluate the dose proportionality of the pharmacokinetics~     (explores what the body does to the drug) of tramadol in healthy adult participants.~   "
134968|NCT01800669|"~     The investigators hypothesize that by adding a patient screening and physician alerting~     module to a computer-based decision support system, the investigators can improve the~     detection and management of legal issues that may affect children's health. this randomized~     controlled trial will place the module in two clinics using the CHICA decision support system~     and compare the rate of detection and resolution of medical-legal issues in those clinics~     compared to two clinics using the CHICA system without the medical-legal module.~   "
134969|NCT01800656|"~     The aims of this study were to examine: 1) safety and feasibility of antiplatelet therapy~     interruption 7 days prior to polypectomy in patients with long-term antiplatelet therapy; 2)~     safety and feasibility of endoloop assisted snare polypectomy in patients with long-term~     antiplatelet therapy; 3) safety and feasibility of so called ligate and let go approach in~     patients with long-term antiplatelet therapy.~   "
134970|NCT01800643|"~     The purpose of this prospective study is evaluate the best dose of busulfan for each patient~     undergoing Haematopoietic Stem Cell Transplantation~   "
134971|NCT01800630|"~     Open-label Phase 1 sequential dose-escalation study of 10 increasing doses (3 to 6 patients~     each)to determine and characterize the DLTs and MTD of gemcitabine HCl oral formulation~     (D07001-F4). Patients will be assigned to receive oral D07001-F4 on Days 1, 3, 5, 8, 10, and~     12 of 4 21-day cycles each to further characterize safety and tolerability.~   "
134972|NCT01800617|"~     The purpose of this study is to test a new thyroid hormone preparation. The thyroid gland~     produces two thyroid hormones: mostly T4 and a smaller amount of T3. Thyroid hormone therapy~     for hypothyroidism or thyroid cancer is generally provided using levothyroxine, which is a~     synthetic form of T4. T4 is converted into the active hormone T3 in the circulation.~     Therefore, some researchers believe that T3 levels in T4-treated patients may be slightly~     lower than in individuals whose own thyroid gland is functioning normally. Symptoms of~     hypothyroidism have been suggested to occur because of this possible T3 deficiency, although~     this is controversial. Studies of T3, added to or substituted for T4 in traditional~     levothyroxine regimens, have generally not shown any benefit of T3. However, it is still~     possible that no benefit is seen because of the short duration of action or half-life of~     T3. This short-life makes it necessary to dose T3 twice or three times daily. Despite~     multiple daily doses of T3, T3 levels during its therapy tend to be troubled by peaks and~     troughs. These peaks can be associated with symptoms of excessive thyroid hormone levels.~     This study will look at TSH and thyroid hormone levels following a daily dose of a new~     preparation of T3 that may have longer duration of action than liothyronine. This preparation~     of T3 is called Thyromax® or BCT303. The investigators believe that steady levels of T3 will~     be seen after taking Thyromax®. The investigators believe that in patients with~     hypothyroidism use of Thyromax® in the correct dose will produce normal TSH levels, without~     producing symptoms of too much thyroid hormone. The goal of future studies is to test whether~     Thyromax® may be a potential treatment for hypothyroidism, by comparing it with traditional~     levothyroxine therapy.~   "
134973|NCT01800604|"~     Many individuals with multiple sclerosis (MS), spinal cord injury (SCI), acquired amputation~     (AMP), muscular dystrophy (MD), and low back pain (LBP) experience pain. There has been~     little research on how to treat this pain. Different types of treatment that include~     self-hypnosis, education about chronic pain, and learning skills on how to change how a~     person thinks about his/her pain have been used to treat chronic pain in the general~     population. The purpose of this study is to see if these different treatments can help~     decrease pain in people with multiple sclerosis and spinal cord injury, and determine how and~     why these treatments are effective. A subject must have a diagnosis of MS,SCI, AMP, MD, or~     LBP, have chronic pain, and be at least 18 years old to participate.~   "
134974|NCT01800591|"~     The goal of this study is to compare a novel approach using financial incentives to changes~     in health benefit design and their impact on employee weight loss.~   "
134975|NCT01800578|"~     the aim of this study was to estimate the relations between Bispectral Index values and~     explicit or implicit memory or dreams during two different minimal alveolar concentration~     (MAC) of sevoflurane in patients undergoing blended anaesthesia for major abdominal surgery~     and ,in this way, estimate the possibility to reduce, in presence of a deep analgesia, like~     epidural analgesia, the requirement of halogenated volatile anesthetics.~   "
134976|NCT01800565|"~     Precocious puberty (PP) in girls is classically defined by the onset of secondary sexual~     characteristics before eight years of age, but subsequent pubertal maturation can be quite~     varied. In many girls, PP takes a rapid course of progression (rapidly progressive precocious~     puberty; RP-PP) with an early menarche and fusion of the epiphyseal growth plates, leading~     eventually to a reduced final height if not treated. In a subset of girls with PP however,~     the growth rate slows to normal for age, skeletal maturation progresses in accordance with~     chronological age and there is little to no risk of impairment of final height (slowly~     progressive precocious puberty; SP-PP). Other conditions of non-progressive PP include~     premature breast budding and unsustained PP that is characterized by a spontaneous regression~     of sexual precocity. Due to their benign course, slowly progressive (SP) PP and other~     non-progressive forms of PP do not warrant therapy with GnRH agonists. Differentiating these~     forms from RP-PP is therefore essential to prevent unnecessary intervention in a population~     that accounts for at least 50% of girls with PP. A distinction between these forms of PP may~     be difficult on clinical grounds however, since all these patients may present initially as~     isolated breast development.~      The gold standard for the diagnosis of true (central) PP is the measurement of gonadotropins~     following GnRH stimulation test. There is however an overlap between prepubertal and early~     pubertal values and between girls with premature breast budding and progressive PP. It was~     suggested therefore that progressive pubertal development and growth acceleration should be~     documented over a 3- to 6-months period before GnRHa therapy in initiated.~      More than a decade ago several studies demonstrated that urinary gonadotropins are age~     related and significantly increased during puberty. It has been suggested that urinary~     gonadotropins measurements can be used for differential diagnosis of pubertal disorders. This~     is based on the assumption that gradual elevation of nocturnal LH secretion prior to and at~     the onset of puberty can be reflected by first-voided urinary LH (ULH). In this prospective~     study, the investigators aimed to evaluate the value of first-voided ULH measurements in~     predicting pubertal course and differentiating SP-PP from RP-PP, by comparison to~     GnRH-stimulated gonadotropins.~   "
134977|NCT01800552|"~     The purpose of this study is to determine whether commercial ultrasound imaging systems can~     discern normal from infiltrated tissue near a peripheral intravenous site.~   "
134978|NCT01800539|"~     Based on the need to characterize and improve early intervention services for minority and~     under-resourced children with ASD, this study translates a manualized and proven training~     model to examine its impact on the use of evidence-based practices (EBP) by early~     intervention providers, and to examine its relationship to child and family outcomes. By~     highlighting the impact of EBP-focused training on participating providers, children, and~     families, findings of the proposed study have the potential to effect significant change in~     the organization and delivery of early intervention services for minority and under-resourced~     children with ASD.~   "
134979|NCT01800526|"~     Part 1: A pilot study in patients with homozygous S (HbSS) or hemoglobin S with beta zero~     thalassemia(HbS-βo thalassemia), with the aim of examining the effect of intravenous NAC~     treatment on plasma VWF parameters and measures of redox and RBC function.~      Part 2: A pilot study in patients with sickle cell disease admitted to the hospital in~     vaso-occlusive crisis to determine the effects of NAC infusions on plasma VWF parameters and~     measures of redox and RBC function, and on measures of pain and hospital length of stay.~   "
134980|NCT01800513|"~     This proposed research is a single center, prospective, single-blinded, randomized controlled~     trial, designed to evaluate IVF pregnancy outcomes following endometrial injury in 254~     patients with implantation failure. Patients will be identified during their work-up and~     treatment at Shady Grove Fertility Reproductive Science Center. Only Shady Grove patients are~     eligible for the study. The investigators hypothesize in patients with one or more previous~     failed day 5 blastocyst transfers, injury to the endometrium via endometrial biopsy will~     improve clinical pregnancy outcomes compared to controls.~   "
134981|NCT01800500|"~     This randomized clinical trial studies interest in smokeless tobacco product as a~     substitution for cigarettes in current smokers. Use of smokeless tobacco products may help~     people stop smoking. Measuring use of other sources of nicotine for cigarettes under a~     variety of different conditions may help determine whether and how much smokers are willing~     to use substitutions~   "
134982|NCT01800487|"~     Hepatitis is one of the most common adverse effect from anti-tuberculosis. Silymarin showed~     its efficacy to decreased serum alanine transaminase enzyme in animal models from recent~     study. No confirmed this efficacy was performed in human.~      A prospective, double-blind, placebo-controlled trial was carried out according to Good~     Clinical Practice Guideline. This study is to define the efficacy of silymarin to prevent~     hepatotoxicity from anti-tuberculosis drugs. Informed consent is obtained prior to the study.~     New patients diagnosed with tuberculosis are enrolled. Patients with liver diseases, current~     alcohol drinking more than 20 g/day, regular use of herbal or other potential hepatotoxic~     drugs are excluded. Patients are treated with a standard regimen of four anti-tuberculosis~     therapy. They will randomize to receive either placebo or silymarin (140 mg) thrice daily.~     Liver function test (LFT) and clinical changes are assessed at 2- and 4-week after initiation~     of the treatment. DILI from anti-tuberculosis drugs ('atb-DILI') is defined as: i) a rise of~     alanine aminotransferase (ALT) to 2 times above normal upper limit, or ii) an elevation of~     total bilirubin more than 2 mg/dl with or without ALT elevation. The study endpoints are the~     level of ALT by week 4 and the number of patients who developed atb-DILI.~      Statistical analysis is used to compare the differences in ALT and number of atb-DILI~   "
134983|NCT01800474|"~     A multe-center, non-interventional study in Europe to evaluate Pliaglis in daily practice~   "
134984|NCT01800461|"~     Participation in valued activities following stroke is a recognized problem. Efficient and~     effective interventions to address this problem have not yet been established although the~     literature provides direction as to the needs of stroke survivors and important parts of~     interventions to address these needs. Occupational Performance Coaching (OPC) is an emerging~     approach to enabling occupational performance or participation in valued activities that~     includes these important parts of interventions. The primary goal of OPC is ability and~     satisfaction with participation in chosen activities, while promoting a client's ability to~     address future problems with participation. OPC has been successfully used with parents and~     their children in addressing problems with participation.~      OPC has not been explored among adults who have experienced a stroke. For this study~     OPC-Stroke (OPC adapted for stroke survivors) will be tested to explore its potential~     effectiveness for increasing participation as well as how feasible and acceptable the~     research methods are. Sixteen participants who receive OPC-Stroke will be compared with~     sixteen who do not using measures of participation, goal achievement, well-being,~     self-efficacy and cognition. Those who receive OPC-Stroke will also be interviewed about~     their experience of the treatment.~   "
134985|NCT01800448|"~     For critically ill patients, it is important to know when to liberate them from mechanical~     ventilation (the removal of breathing or endotracheal tube or extubation) and weaning (the~     progressive decrease of the amount of support that a patient receives from the mechanical~     ventilation). It is well recognized that prolonged ventilation and weaning harms patients and~     introduces significant increased costs to the health care system. The investigators objective~     is to improve the safety of removal of life support in critically ill patients by harnessing~     information from two new technologies; NM3 and Nexus device. In particular, the investigators~     are interested in the patterns of variation of respiratory and cardiac signals from the NM3~     device, as well as monitor skin conductance with the Nexus device. The combination of these~     measures has not yet been investigated to date, and could represent a novel set of measures~     that can be used to help physicians better manage critically ill patients. The current~     standard of care dictates that once a patient is considered as a candidate for withdrawal~     from ventilation, a spontaneous breathing trial (SBTs) is performed, where the degree of~     ventilator support is decreased, and their response is observed to help predict if they will~     tolerate extubation.~      Health is associated with a high degree of variation of physiologic parameters such as heart~     rate and respiratory rate, and illness & stress are associated with a loss of variability.~     The analysis of variability of biological signals measures the degree of fluctuations present~     over time. Previous studies have demonstrated that changes in variability (generally~     decreases) are observed in illness states, and the degree of this change correlates with~     illness severity. Several studies have reported that reduced heart or respiratory rate~     variability (HRV or RRV) during SBTs is associated with extubation failure. Until recently,~     variability analysis has traditionally been done only on heart rate (HRV), derived from~     analyzing beat-to-beat intervals from the ubiquitous electrocardiogram (ECG). The~     investigators aim to apply variability analysis to the respiratory and cardiac signals which~     represent a rich novel set of muti-organ variability measures whose utility in managing~     extubation and ventilator weaning has not been investigated to date.~   "
134986|NCT01800435|"~     Activated prothrombin complex concentrate (aPCC) and recombinant activated factor VII~     (rFVIIa) are the only two drugs that are available to treat bleeds in haemophilia A patients~     with high titer inhibitors. However, management of bleeds in these patients can be~     challenging due to variation in response and lack of standardized methods to monitor the~     effect. We hypothesized that significant increase in whole blood clot stability could be~     achieved when tranexamic acid was given concomitantly with bypassing-agents while thrombin~     generation remains unaffected. In this prospective crossover study the effect of aPCC and~     rFVIIa with and without TXA on clot stability and thrombin generation capacity (ETP) were~     studied, using thromboelastography (ROTEM) and thrombin generation assay (TGA), respectively.~     In addition, the risk of thrombosis and disseminated intravascular coagulation (DIC) was~     assessed.~   "
134987|NCT01800422|"~     The purpose of this study is to determine whether or not the medication that blocks the~     effects of the hormone progesterone (CDB-4124 or Proellex) will decrease the growth rate of~     breast cancer cells as compared to a placebo. CDB-4124 (also called Proellex) is a medication~     that works against the hormone, progesterone. The researchers in this study would like to~     compare changes in breast cancer cells of women who have taken CDB-4124 prior to surgery to~     those from women who have taken a placebo pill prior to surgery.~   "
134988|NCT01800409|"~     Compromised respiratory function as a result of tetraplegia is a leading cause of~     rehospitalisation for the tetraplegic patient group. Electrical stimulation of the abdominal~     muscles has previously been used to improve the respiratory function of tetraplegic patients~     in the chronic stage of injury. In this study the investigators aim to evaluate the optimum~     protocol for the use of electrical stimulation of the abdominal muscles to improve the~     respiratory function of the tetraplegic population. The investigators also aim to investigate~     whether abdominal functional electrical stimulation combined with mechanical~     insufflation-exsufflation can be used to help further improve the respiratory function of the~     tetraplegic population.~   "
135047|NCT01799629|"~     To evaluate the efficacy of prophylactic glycerin suppositories will accelerate the~     elimination of meconium from the large intestine and thus reduce the incidence of feeding~     intolerance in very low birth weight (VLBW) infants~   "
134989|NCT01800396|"~     Background: The incidence of gastrointestinal infections is very high. In Western countries~     at least 30% of the population suffers from at least one food-borne infection per year.~     Mostly because of the problem of antibiotic resistance, more emphasis is put on prevention of~     infections. One of the possibilities is to strengthen human resistance to gut infections by~     consumption of milk ingredients.~      Aim: To study whether a milk protein concentrate rich in phospholipids improves the~     resistance of humans to enterotoxigenic E. coli (ETEC).~      Study design: The MIRAGE study is a parallel, double-blind, placebo-controlled 4-weeks~     intervention with a milk protein concentrate rich in phospholipids in healthy subjects of~     18-55 yrs of age. Participants will be randomly assigned to the milk protein concentrate rich~     in phospholipids or placebo group (n=30 per group). Subjects will be instructed to maintain~     their usual pattern of physical activity and their habitual food intake, but to standardize~     their dietary calcium intake. After an adaptation period of 2 weeks, subjects will be orally~     infected with a live, but attenuated, ETEC vaccine (strain E1392-75-2A; collection NIZO food~     research; dose will be 1010 CFU). Before and after infection, an online diary will be kept to~     record all food and drinks consumption (2x2 days) to assess the habitual dietary intake. The~     diary will also be used for daily recording of bowel habits and frequency and severity of~     gastrointestinal complaints.~      The following biological samples will be collected: 4x10 ml venous blood, a single fecal~     bolus (for screening) and 7x24 hrs feces. Blood is sampled for immune response analyses and~     the fecal samples are collected to quantify several infection- and immune system markers and~     to verify dietary calcium intake. Saliva is sampled three times before and after infection to~     quantify immune system markers.~      Primary outcomes: Fecal ETEC excretion and severity of diarrhea (quantified by fecal output~     per day).~      Secondary outcomes: Serum immune response to ETEC, self-reported stool consistency scores and~     gastrointestinal complaints, relative fecal wet weight.~   "
134990|NCT01800383|"~     Posttraumatic stress disorder (PTSD) is a common and debilitating neuropsychiatric disorder~     in which an acute fear response to a traumatic event does not abate. This failure to recover~     from trauma is thought to be due at least in part to a deficit in learning not to fear~     situations and stimuli previously associated with the trauma (i.e., specifically due to a~     failure of extinction recall). Pavlovian fear conditioning can be simulated and measured~     experimentally in humans using a 2-day fear conditioning paradigm developed by our group,~     wherein conditioning and extinction learning phases are conducted on Day 1, and extinction~     recall is tested on Day 2.~      Recent functional magnetic resonance imaging (fMRI) evidence indicates that PTSD is~     associated with hyper-responsivity of the insular cortex and hyporesponsivity of the~     ventromedial prefrontal cortex (VMPFC) during exposure to fear-inducing stimuli, consistent~     with altered excitability of brain regions mediating fear conditioning and extinction. As the~     brain's principal inhibitory neurotransmitter, GABA exerts a prominent role in modulating~     neuronal excitability. Interestingly, there are reports that adjunctive treatment with~     GABA-enhancing antiepileptics is efficacious in PTSD. There is also evidence, albeit~     inconsistent, that lower serum GABA levels predict a more chronic course of the illness.~     However, it is unclear whether serum levels accurately reflect brain GABA, which may~     contribute to inconsistency of serum findings. Moreover, it is possible that GABA alterations~     may vary in their presence, nature and significance across brain regions implicated in PTSD.~     The proposed study will examine the relationship of PTSD symptoms and behavioral fear~     conditioning deficits with regional brain gamma-aminobutyric acid (GABA) using proton~     magnetic resonance spectroscopy (1H-MRS).~      We have the following aims and hypotheses:~        1. To determine whether GABA alterations are associated with the categorical diagnosis of~          PTSD and not merely exposure to trauma. It is hypothesized that PTSD will be associated~          with higher GABA in VMPFC and lower GABA in the right insula.~        2. To determine whether GABA levels are significantly associated with dimensional measures~          of PTSD symptom severity and individual symptom dimensions. It is predicted that higher~          GABA in the VMPFC and lower GABA in the right anterior insula will be associated with~          greater total symptom severity.~        3. To determine whether GABA in VMPFC and right anterior insula are significantly~          associated with measures of extinction recall failure and anxiety sensitivity in PTSD.~          It is hypothesized that VMPFC GABA will be positively correlated with skin conductance~          response to a conditioned stimulus that had previously been extinguished and insula GABA~          will be negatively correlated with anxiety sensitivity.~   "
134991|NCT01800370|"~     Aging in men reduces the amount of luteinizing hormone (LH) and testosterone (Te) secreted in~     each burst. Stress-associated mechanisms introduced by acute illness and chronic disease~     decrease LH and Te secretion further. A major unresolved issue is whether the aging process~     heightens the negative effects of a stressor (whether physical or metabolic) upon LH and Te~     secretion. This study will assess LH and Te secretion in response to a physical stressor~     (maximal exercise) and a common metabolic stressor (hyperglycemia) as a function of age in~     healthy men ages 18-80 yr.~   "
134992|NCT01800357|"~     This study seeks to evaluate the efficacy and safety of mildronate injection in treating~     acute ischemic stroke~   "
134993|NCT01800344|"~     The study compares the incidence of pharyngolaryngeal complications in patients managed with~     either a pressure-limiting strategy using the AES Ultra CPVTM or a standard practice using a~     LMA, in ambulatory surgery patients.~   "
134994|NCT01800331|"~     In Canada, the number of obese children and adolescents has increased tremendously.~     Interventions addressing diet and physical activity have been successful in the short-term.~     However, a great number of individuals have difficulties maintaining achieved weight loss and~     returning to treatment sessions.~      New technology interventions, through the web or delivered trough Personal Digital Assistants~     (PDAs) (e.g. iPhone or Blackberry), are increasingly being used in health interventions. PDAs~     have emerged as appealing in health interventions as they are easily accessible and their~     interactivity makes them well suited to promote long-term engagement in behaviour change~     interventions.~      This study will look at the utility of supplementing a family-based lifestyle program for~     overweight and obese adolescents (Shapedown BC) with a PDA intervention (Text2bHealthy)~     focussing mainly on physical activity, sedentary behaviours, and dietary intake to maintain~     treatment success by improving self-management skills. Adolescents and will receive~     Text2bHealthy for 3-months after 3 months participation in the Shapedown BC program.~      Results from this study will provide needed information on how to improve treatment adherence~     and maintenance outcomes through the use of innovative methods and will ultimately contribute~     to the improvement of long-term outcomes in obesity treatment.~   "
134995|NCT01800318|"~     The purpose of the study is to determine whether noninvasive electrical stimulation at~     acupuncture points (NESAP) and/or 24% sucrose is effective in reducing pain in infants during~     invasive procedures.~      The investigators hypothesize that:~        -  Gentle noninvasive electrical stimulation at selected acupuncture points and/or oral use~          of 24% sucrose with pacifier will reduce the newborn infant's responses to heelstick~          pain, as measured by the Premature Infant Pain Profile (PIPP), heart rate variability,~          duration of crying, and salivary cortisol levels.~        -  The effects of combined therapies will be additive.~        -  The analgesic effects of NESAP and/or sucrose will continue for the duration of the~          heelstick, reflected by the first two minutes of heelstick and the first two minutes of~          recovery.~   "
134996|NCT01800305|"~     The object of this randomized, parallel, positive controlled study is to explore the~     pharmacokinetics and pharmacodynamics profile of the test drug after single-dose subcutaneous~     administration, compared to the comparator drug (EPIAO®) after multiple-dose subcutaneous~     administration, by assessing plasma concentration of the drug and the reticulocyte count,~     hemoglobin concentration and hematocrit following subcutaneous administration, evaluate the~     security and tolerability of the test drug in healthy subjects, and provide sufficient~     information for dose selection in the future phase II and III study.~   "
134997|NCT01800292|"~     The purpose of this study is to determine if patients with pulmonary hypertension and mildly~     elevated heart pressure known as PCWP will exhibit different patterns on echocardiography and~     that these patterns will predict treatment response to sildenafil, a drug given for this~     condition.~   "
134999|NCT01800266|"~     The primary goal of this study is to examine the impact of varying supervision strategies on~     clinician fidelity and client outcomes in a community-based setting. Prior research has~     established that training approaches that do not include a period of intervention-specific~     supervision or consultation are ineffective and that implementation efforts that include only~     an initial period of supervision show an eventual attenuation of gains in knowledge and~     fidelity in practice. Ongoing supervision may be required for effective and sustained~     implementation of evidence-based practices (EBPs) in community-based settings. However,~     supervision is one of the least investigated aspects of training. Gold standard elements of~     supervision from efficacy trials include review of sessions, standardized procedures for~     monitoring client outcomes and model fidelity, and ongoing skill-building (e.g., behavioral~     rehearsal). The degree (e.g., frequency, intensity) to which these strategies are used in~     community-based settings is unknown.~      There are a growing number of national and statewide efforts to increase the reach of EBPs~     through dissemination and implementation initiatives. There are 18 statewide initiatives to~     implement Trauma-focused Cognitive Behavioral Therapy (TF-CBT), an EBP for child trauma~     exposure and sequelae. Many of the community based TF-CBT implementation efforts, and those~     for other EBPs, include a specific focus on supervisors. However, the limited scientific~     literature provides very little guidance for these efforts. Aims of the current trial include~     1) studying supervision with existing implementation supports; particularly presence of gold~     standard elements; 2) evaluating the effects of varying supervision strategies on fidelity~     and client outcomes; and 3) testing the mediating effect of treatment fidelity on the~     relationship between supervision type and client outcomes. We propose a two-phased,~     within-subjects and between subjects design. In Phase I (9 months), we examined supervision~     with implementation support. In Phase II (30 months), we will examine two specific~     supervision conditions, each including varying EBP supervision elements.~   "
135000|NCT01800253|"~     The study proposes to investigate whether acute total deprivation affects metabolism as~     measured through blood and peripheral tissues. Its aim is also to investigate how acute total~     sleep deprivation affects neurodegenerative markers, as well as hormones, memory performance~     and aspects of appetite regulation.~   "
135001|NCT01800240|"~     Objective:~      subjects to compare the single dose bioavailability of Torrent's Pioglitazone Hydrochloride~     and Metformin Hydrochloride Tablets 15 mg/850 mg and Actoplus Met® (pioglitazone~     hydrochloride and metformin hydrochloride) Tablets 15 mg/850 mg of Takeda Pharmaceuticals~     America, Inc. USA. Dosing periods of studies were separated by a washout period of 14 days.~      Study Design:~      Randomized, Two-Way Crossover, Single-Dose, and Open-Label~   "
135002|NCT01800227|"~     Objective:~      subjects to compare the single dose bioavailability of Torrent's Pioglitazone Hydrochloride~     and Metformin Hydrochloride Tablets 15 mg/850 mg and Actoplus Met® (pioglitazone~     hydrochloride and metformin hydrochloride) Tablets 15 mg/850 mg of Takeda Pharmaceuticals~     America, Inc. USA. Dosing periods of studies were separated by a washout period of 14 days.~      Study Design:~      Randomized, Two-Way Crossover, Single-Dose, and Open-Label~   "
135003|NCT01800214|"~     The prospect of disease-modifying therapies in the pipeline for Alzheimer's Disease (AD) has~     intensified efforts to use brain imaging more effectively for diagnosis and monitoring of~     dementing illnesses. There is also emerging awareness of the destructive interplay between AD~     and Cerebrovascular Disease (CVD) in our aging population; both disorders share common~     vascular risk factors and may respond to similar prevention treatments. Brain mapping~     techniques capitalize on the fact that different neurodegenerative diseases target particular~     brain areas. Brain shrinkage and stroke disease can be quantified on Magnetic Resonance~     Imaging (MRI) using computerized analysis.~      This ongoing study applies advanced MR imaging analysis, genetic testing and standardized~     cognitive and functional assessments done at yearly intervals to measure and monitor~     longitudinal change in patients with AD, vascular and other neurodegenerative diseases and~     potentially to measure modifying effects of emerging therapies. Over 1000 patients (Mild~     Cognitive Impairment or dementia from AD, Vascular, Frontotemporal or Lewy Body Disease) and~     125 normal elderly have already been enrolled, with 150 autopsies.~      This study utilizes specialized imaging analysis software packages to reliably quantify brain~     tissue volumes and small vessel disease, the most common type of CVD. Results from this study~     will help to improve diagnosis, to customize treatment, and to better monitor~     disease-modifying therapies currently under investigation should they become applicable to~     everyday practice.~   "
135004|NCT01800201|"~     The goal of this proposal is to test the implementation of an innovative approach to~     improving health and lowering cost for a high risk population of patients with acute~     myocardial infarction (AMI) immediately post-hospitalization. The investigators will~     implement a new service delivery approach that will provide a foundation for a payment system~     that rewards keeping high-risk patients healthy and that deploys technology and a health care~     workforce of the future to implement prevention, care coordination, care process~     re-engineering, team-based care, and the use of data to support new care delivery models.~     This program is focused on coronary artery disease (CAD), but we expect that a successful~     implementation of this model will demonstrate a sustainable pathway to the three-part aim not~     just for CAD, but for many other conditions whose outcomes are highly sensitive to~     post-discharge coordination.~      This proposal has three main principles:~        1. Principles of behavioral economics that have been developed, refined, and tested over~          the past decade offer practical insights into health behaviors that were previously~          unavailable and are not reflected in existing care models.~        2. New technology, typically wireless devices for pill bottles, and mobile telephones, make~          engagement with patients substantially easier and more immediate now than ever before.~        3. While randomized clinical intervention trials provide exceptional confidence of~          comparative effectiveness in narrow interventions, they are slow and rigid and dont~          reflect the urgency that health care transformation currently requires. Principles of~          rapid cycle innovation are gaining acceptance as an alternative to or supplement of~          these traditional methods in supporting evidence for implementation success.~   "
135005|NCT01800188|"~     Disturbed glucose metabolism is a common feature of patients with end-stage renal disease~     (ESRD). Several hormones responsible of a stable blood glucose including insulin, glucagon,~     and the gastrointestinal insulinotropic hormones Glucagon-like Peptide-1 (GLP-1) and~     Glucose-dependent Insulinotropic Peptide (GIP) are elevated in patients with ESRD. These~     hormones are all medium sized peptides which theoretically makes them removable during high~     efficient hemodialysis. A significant removal could have consequences for the treatment of~     patients with diabetes and ESRD.~      The purpose of this study is to determine whether insulin, glucagon, GLP-1 and GIP are~     cleared during high efficient hemodialysis and hemodiafiltration. The investigators~     hypothesize that a significant amount of these hormones is removed during hemodialysis and to~     a larger extend during hemodiafiltration.~   "
135048|NCT01799616|"~     The purpose of this study is to determine whether pamidronate is effective and well-tolerated~     in the treatment of painful degenerative disk disease, also known as Modic type 1 changes~   "
135006|NCT01800175|"~     The purpose of this study is to evaluate retention and replacement of the OTX Punctum Plug~     when placed in the canaliculus of the eyelid. Subjects will be followed for up to 1 year in~     order to assess retention and replacement of the OTX Punctum Plug for this duration. At the~     Day 90 visit, subjects will receive a second OTX Punctum Plug after removal of the initial~     OTX Punctum Plug. The subject will return for visits at Day 180, 270 and 360. On Days 180 and~     270, the subject will again receive a new OTX Punctum Plug after the previous OTX Punctum~     Plug is removed.~   "
135007|NCT01800162|"~     This is a randomized controlled trial to compare three currently available management~     strategies for women with a persisting pregnancy of unknown location (PPUL), which makes them~     at-risk for ectopic pregnancy. We will recruit hemodynamically stable women with a confirmed~     PPUL to be randomized to one of three strategies: 1) Uterine evacuation followed by~     methotrexate (MTX) for some (those that have evidence of a non visualized ectopic pregnancy)~     2) Empiric treatment with MTX for all, and 3) Expectant management. Randomization will be~     2:2:1 into these three arms. After randomization, they will be followed and treated~     clinically as is indicated by the progression of their condition. Primary outcome measures:~     uneventful decline of hCG to 5 IU/mL. Secondary outcome measures: re-interventions, treatment~     complications, health-related quality of life, financial costs, future fertility, and~     patient's preferences.~   "
135008|NCT01800149|"~     Aim of the present investigation will be to evaluate the role of a bovine-bone mineral and a~     collagen membrane as ridge augmentation procedure following tooth extraction. 20 consecutive~     adult patients, requiring tooth extraction in the frontal area of the upper and lower arch~     maxilla (from second premolar to second premolar), will be enrolled into the study.~      After tooth extraction, sockets will be randomized and divided into two groups: in Group A~     the socket will be grafted with Bio-Oss Collagen , in Group B the sockets will be grafted~     with BioOss granules (small granules). The graft will be covered with porcine collagen~     membrane (BioGide). Then, the flap will be sutured.~      MEASUREMENTS:~      The end of the study will be fixed at the 6 months evaluation after tooth extraction.~     Impression will be taken before tooth extraction and after 6 months in order to create cast~     models. On the cast models, using reference PVC (polyvinylchloride) guides, the horizontal~     dimension of the soft tissues will be measured. One measurement per tooth will be recorded,~     at T0 (before extraction) and T2 (after 6 months).~      A 3D radiological image, using the CBCT technique, will be obtained at the end of the~     surgical stage T1 (extraction + bone graft) and after 6 months of healing. Superimposition~     will be performed in order to measure hard tissue remodelling.~      After six months (T6), a a biopsy specimen will be also harvested for that augmented~     extractions sockets on which an implant installation has been previously planned.~   "
135009|NCT01800136|"~     The aim of this study is to compare analgesic efficacy of two non invasive techniques based~     on motor cortex stimulation in neuropathic pain patients. High frequency repetitive~     transcranial magnetic stimulation (HF-rTMS) of primary motor cortex has been demonstrated to~     induce an analgesic effect significantly different from placebo; this effect is clinically~     useful if rTMS sessions are applied daily during five consecutive days. Transcranial direct~     current stimulation (tDCS) is a new approach of non invasive cortical stimulation but its~     efficacy in neuropathic pain has been not yet established. The investigators propose to~     compare the analgesic effect of 5 tDCS sessions applied daily to a similar protocol using~     HF-rTMS. In parallel to the clinical therapeutic evaluation, functional-MRI will be performed~     before and after the five sessions of rTMS and tDCS, in order to reveal the potential~     plasticity induced within motor somatotopic map of the primary motor cortex.~   "
135010|NCT01800123|"~     There is no consensus on monitoring criteria in acute self poisoning. Clinical scores, vital~     signs or lactatemia have failed to prove good predictive value.~      The main acute self poisoning complication is decreased consciousness level with consequent~     increased risk of hypoxemia and aspiration pneumonitis.~      Several clinical studies have recently shown that EtCO2 monitoring can be valuable in~     procedural sedation in the emergency department. It is able to predict hypoxemia before any~     SaO2 decrease and any complications related to these procedures.~      We therefore hypothesized that EtCO2 could help in acute self poisoning patients' monitoring~     in the ED.~   "
135011|NCT01800110|"~     Many medicinal effects of Pomegranate juices are already known. Mainly known for its~     anti-viral, anti-bacterial and anti-oxide tendency of pomegranate juice.~      Many studies which have demonstrated antioxidant activity of pomegranate juice in the blood~     and blood cells were published.~      In addition, published studies have demonstrated the anti-oxidant activity which inhibit the~     development of atherosclerosis and stroke, even in patients with diabetes, and its effect of~     decreasing systolic blood pressure in patients with systemic hypertension.~      The purpose of the work is to examine the effect of drinking pomegranate juice on the level~     of anti-oxidants in human breast milk.~   "
135012|NCT01800097|"~     This study is an investigator initiated placebo controlled double blinded trial. The~     hypothesis is that treatment with modafinil positively will affect behavioural and cognitive~     rehabilitation after stroke, causing the treatment group to experience decreased fatigue,~     increased endurance, improved skills of sustaining attention and faster reaction times. The~     cognitive rehabilitation will show in increased muscle mass, decreased osteoporosis and~     better physical performances due to a higher level of physical activity.~   "
135013|NCT01800084|"~     The main objective of this study is to demonstrate the non-inferiority of SPECT image quality~     (as measured by the signal / noise ratio) obtained by ASIR reconstruction of very-low-dose CT~     acquisitions versus the quality of those obtained by filtered back projection (FBP) of~     low-dose CT acquisitions.~      The lower limit of non-inferiority is set to -1, the average SPECT signal / noise ratio TEMP~     expected is between 5 and 6.~   "
135014|NCT01800071|"~     This clinical study is looking at a vaccine called MVA-EBNA1/LMP2. This is a new vaccine that~     has already been studied in small number of cancer patients.~      The vaccine is designed to boost a patient's immunity against a common virus. The virus is~     called Epstein Barr virus or EBV. EBV is sometimes found inside cancer cells and is commonly~     found in nasopharyngeal cancer cells.~   "
135015|NCT01800058|"~     The detection and quantification of Circulating tumor cells CTCs in peripheral blood of~     patients with prostate adenocarcinoma may be useful at least for:~      Getting a correct stratification of patients with high-risk prostate cancer (PCa).~      Set the prognosis at baseline. Evaluate the response to different treatments (predictive~     value and monitoring).~      Establish individualized therapies.~   "
135017|NCT01800032|"~     This prospective pilot study is designed to provide preliminary data on the use of~     Fluorodeoxyglucose Positron Emission Tomography-Magnetic Resonance Imaging (FDG-PET-MRI) in~     patients with neurofibromatosis-1 (NF1) associated optic glioma and plexiform neurofibroma~     (PN).~      Subjects will undergo FDG-PET-MRI scans in place of standard of care imaging at 0 and 12~     months, unless more frequent imaging is clinically indicated. Subjects and their family~     caregivers will also undergo serial interviews and complete questionnaires related to the~     psychosocial aspects of NF1.~   "
135018|NCT01800019|"~     The objectives of this trial are:~      Primary objectives:~        1. To determine among HIV+ individuals whether varenicline or NRT is more effective at~          helping individuals remain abstinent from smoking tobacco.~        2. To determine among HIV+ individuals whether varenicline or NRT has the lowest~          side-effect profile.~        3. To determine if the HIV tailored Quit Smoking Counselling Intervention, plus smoking~          cessation drug therapy, improves smoking cessation rates compared to smoking cessation~          drug therapy alone with usual care.~      Secondary objective:~      1. To determine whether the use of varenicline/NRT is safe in HIV+ patients who exhibit~     depressive symptoms.~      Hypothesis:~      That varenicline will result in higher quit smoking rates and that NRT will result in a lower~     side effect profile. Further, the HIV tailored quit smoking intervention will result in~     higher rates of smoking cessation over and above the pharmacological treatment alone. And~     finally, varenicline will be safe to use for HIV + individuals who exhibit depressive~     symptoms.~   "
135019|NCT01800006|"~     This international study is a prospective noninterventional observational cohort study of~     patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine~     treatment conditions to prevent stroke or non-central nervous system systemic embolism.~     Patients will be followed up for 1 year or until 30 days after end of rivaroxaban therapy in~     case of therapy was discontinued earlier than 12 months. Serious adverse events will be~     followed up adequately. Laboratory values (e.g., Hb, HCT, haemoccult) should be documented~     for each point in time they were measured.~   "
135020|NCT01799993|"~     To demonstrate that as adjunctive therapy to intravenous (IV) antibiotics, BAY 41-6551 400 mg~     (amikacin as free base) administered as an aerosol by the Pulmonary Drug Delivery System~     (PDDS) Clinical every 12 hours is safe and more effective than placebo (aerosolized normal~     saline) administered as an aerosol by the PDDS Clinical every 12 hours, in intubated and~     mechanically-ventilated patients with Gram-negative Pneumonia. The secondary endpoint~     objectives are to evaluate the superiority of aerosolized BAY 41-6551 versus aerosolized~     placebo in pneumonia-related mortality, the Early Clinical Response at Day 10, the days on~     ventilation, and the days in the intensive care unit (ICU).~   "
135021|NCT01799980|"~     This study will compare two different methods of staging lung cancer to determine whether~     endobronchial ultrasound (EBUS) staging of mediastinal lymph nodes will provide good~     diagnostic yield in detecting lung cancer, when compared to current methods of a staging~     bronchoscopy and cervical mediastinoscopy.~   "
135022|NCT01799967|"~     This study will assess short and long term outcomes of individuals undergoing minimally~     invasive surgery of the gastro-esophageal junction (MISGEJ). Patients will respond to~     questionnaires on an annual basis evaluating quality of life and functionality following~     MISGEJ. Hospital charts will also be reviewed on an annual basis to assess patient health~     outcomes.~   "
135023|NCT01799954|"~     This study will evaluate the safety of and the body's immune response to experimental HIV~     vaccine regimens using different vaccine priming combination, and boosting with the vaccines~     NYVAC and AIDSVAX® B/E.~   "
135024|NCT01799941|"~     The objectives of the study are to evaluate the safety, tolerability, and effectiveness of~     NUEDEXTA capsules containing 20 mg DM (Dextromethorphan)/10 mg Q (Quinidine) for treatment of~     Pseudobulbar Affect (PBA) in patients with prevalent conditions such as dementia, stroke, and~     traumatic brain injury (TBI)over a 12 week period.~   "
135025|NCT01799915|"~     Synucleinopathies are a group of rare diseases associated with worsening neurological~     deficits and the abnormal accumulation of the protein α-synuclein in the nervous system.~     Onset is usually in late adulthood at age 50 or older. Usually, synucleinopathies present~     clinically with slowness of movement, coordination difficulties or mild cognitive impairment.~     Development of these features indicates that abnormal alpha-synuclein deposits have destroyed~     key areas of the brain involved in the control of movement or cognition. Patients with~     synucleinopathies and signs of CNS-deficits are frequently diagnosed with Parkinson disease~     (PD), dementia with Lewy bodies (DLB) or multiple system atrophy (MSA).~      However, accumulation of alpha-synuclein and death of nerve cells can also begin outside the~     brain in the autonomic nerves. In such cases, syncucleinopathies present first with symptoms~     of autonomic impairment (unexplained constipation, urinary difficulties, and sexual~     dysfunction). In rare cases, hypotension on standing (a disorder known as orthostatic~     hypotension) may be the only clinical finding. This pre-motor autonomic stage suggests that~     the disease process may not yet have spread to the brain.~      After a variable period of time, but usually within 5-years, most patients with abnormally~     low blood pressure on standing develop cognitive or motor abnormalities. This stepwise~     evolution indicates that the disease spreads from the body to the brain. Another indication~     of this spread is that acting out dreams (i.e., REM sleep behavior disorder, RBD) a problem~     that occurs when the lower part of the brain is affected, may also be the first noticeable~     sign of Parkinson disease.~      The purpose of this study is to document the clinical features and biological markers of~     patients with synucleinopathies and better understand how these disorders evolve over time.~     The study will involve following patients diagnosed with a synucleinopathy (PD/DLB and MSA)~     and those believed to be in the pre-motor stage (with isolated autonomic impairment and/or~     RBD). Through a careful series of follow-up visits to participating Centers, we will focus on~     finding biological clues that predict which patients will develop motor/cognitive problems~     and which ones have the resilience to keep the disease at bay preventing spread to the brain.~     We will also define the natural history of MSA - the most aggressive of the~     synucleinopathies.~   "
135026|NCT01799902|"~     This study is a non interventional study where no investigational medicine is provided.~     Procedures and examination will follow the institution standard of care practice. The~     therapeutic approach will not be decided in advance by the protocol or influenced in any way~     by the protocol.~      After standard evaluation the investigator will decide the treatment strategy and upon~     eligibility criteria met will propose subject to participate to the study. Informed consent~     will be collected for all subjects.~      The study will consist of 3 possible observational visits; V1 (enrolment), V2 and V3 (follow~     up).~      During all observational visits (V1, V2 and V3) the patient will complete the I-PSS~     (International Prostate Symptom Score) questionnaire including Quality Of Life (QOL)~     questionnaire and a Patient assessment of treatment benefit and satisfaction using a Visual~     Analogue Scale (VAS).~      The patient will be asked to complete a voiding diary the first 3 days after Visit 1~     (Baseline diary), 3 days before Visit 2 and again 3 days before Visit 3.~      Prostate Specific Antigen (PSA) measurement- Uroflowmetry - Post Voiding Residual volume and~     Trans Rectal Ultra Sound data will be collected only if available.~      During all observational visits (V1, V2 and V3) the investigator will complete the assessment~     of treatment benefit and satisfaction using a VAS.~   "
135027|NCT01799889|"~     This study will evaluate the efficacy, safety, tolerability, and pharmacodynamics of~     entospletinib. Participants with the following relapsed or refractory hematologic~     malignancies will be enrolled into the study: relapsed or refractory chronic lymphocytic~     leukemia (CLL), mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), follicular~     lymphoma (FL), or non-FL indolent non-Hodgkin lymphomas (iNHL; including lymphoplasmacytoid~     lymphoma/ Waldenström macroglobulinemia [LPL/WM], small lymphocytic lymphoma [SLL], or~     marginal zone lymphoma [MZL]).~   "
135028|NCT01799876|"~     The purpose of this study is to assess the potential benefit of enhancing knee surgery for~     cartilage injury using some of the patient's own cells, taken from fat tissue, that may be~     able to help cartilage to regenerate.~   "
135029|NCT01799863|"~     The purpose of this study is to evaluate the evolution of the symptoms of acute viral~     conjunctivitis using preservative free ketorolac trometamol 0.45% associated with~     carboxymethylcellulose compared with isolated use of preservative-free artificial tears.~   "
135030|NCT01799850|"~     Subjects with type 2 diabetes will be treated with Actos or placebo for eight weeks and~     needle biopsies of muscle will quantify changes in any of seven different glucose transport~     proteins in muscle.~   "
135031|NCT01799837|"~     The objective of this proposal is to collect pilot data to characterize the binding of~     [11C]MENET in combat-exposed war veterans with posttraumatic stress disorder (PTSD).~     Approximately two hundred thousand veterans will be returning stateside upon the end of~     combat operations in Iraq, and 13% of returning veterans will have PTSD. 15% of all war~     veterans will develop chronic PTSD symptoms requiring a lifetime of mental health care.~     Little is known about the dysregulation of PTSD veteran's neurochemical state including the~     noradrenergic system which plays a primary role in memory and stress response. This includes~     heightened anxiety, fear and hyperarousal symptoms characteristic of PTSD. The noradrenergic~     system is a concentration of neurons in the brainstem nucleus, locus coerulues, that have~     projections to the amygdale and prefrontal cortex. The norepinephrine transporter (NET) is~     responsible for regulating and terminating noradrenergic transmission, and is a specific~     marker for neuronal integrity. Hyperactivity of the noradrenergic system up-regulates NET~     protein. An unresolved problem in studying the noradrenergic system is identification of~     suitable radiopharmaceutical to non-invasively measure alterations in the density of NET. The~     investigators propose to address this challenge by using positron emission tomography (PET)~     to measure stress-induced changes in NET expression in combat-exposed war veterans with PTSD.~     The central hypothesis of this proposal is that war veterans with PTSD have an up-regulation~     of NET in the locus coerulues resulting from hyperactivity of the noradrenergic system~     compared to healthy controls. Through a series of experiments, the investigators will~     determine the in vivo binding characteristics of [11C]MENET. The investigators will use this~     information to optimally design an experimental protocol to measure the availability of NET~     in a pilot group of combat-exposed war veterans with PTSD. The aims of this proposal are: 1)~     Measure the uptake kinetics and whole brain distribution of [11C]MENET in combat-exposed~     veterans with PTSD and healthy controls, 2) Develop a quantitative kinetic model of~     [11C]MENET uptake to calculate the NET availability in brain. The subjects undergoing imaging~     in this work will be recruited by Dr. J. Douglas Bremner (Co-Investigator) at Emory~     University and Atlanta Veteran Affairs Hospital. Our long-term goal is to develop a~     longitudinal study framework to assess the NETs dysregulation during onset of PTSD as well as~     its transition to chronic lifetime PTSD.~   "
135032|NCT01799824|"~     The purpose of this study is to confirm the effect of ANT-1403 in the treatment of primary~     axillary hyperhidrosis.~   "
135033|NCT01799811|"~     The objective Study is to evaluate the short- and long-term clinical outcomes of patients~     receiving the CryoVein cryopreserved saphenous vein allograft (CVA) as their primary open~     bypass conduit to assess if there is a quantifiable correlation to time of placement as a~     primary bypass graft and improved long-term clinical outcomes of patients with critical limb~     ischemia (CLI).~   "
135034|NCT01799798|"~     Pilot study to assess the efficacy of a therapy with the RANKL-antibody denosumab in children~     5-10 years of age with mutation in COL1A1 or COL1A2 leading to Osteogenesis imperfecta.~     Efficacy will be assessed by DXA measurements at the lumbar spine of the areal bone mineral~     density (BMD) which is the most frequently used parameter in trials investigating~     osteoporosis.~      The hypothesis of the study is:~      Osteoclastic activity which is increased in OI could be reduced by inhibition of osteoclast~     maturation. Denosumab inhibits maturation of the osteoclasts by inhibiting RANKL. BMD could~     be increased during a 36 week treatment course with denosumab measured after 48 weeks.~   "
135035|NCT01799785|"~     Cirrhosis is associated with a reduction in muscle mass and exercise capacity. This has an~     impact or morbidity and mortality. Regular aerobic exercise training is a proven effective~     therapy to improve exercise capacity in healthy and clinical populations. the effect of this~     training has not yet been evaluated in cirrhosis. The safety of this intervention also~     requires further study. Using a randomized controlled design, the investigators aim to~     conduct a pilot study evaluating the safety and efficacy of eight weeks of aerobic exercise~     training on aerobic capacity.~   "
135036|NCT01799772|"~     Patients who undergo a replacement of their knees are generally older adults who have dealt~     with severe knee pain and joint degeneration for a long time. The majority of them are~     sedentary, and around 1/3 are obese. The knee replacement surgery decreases knee pain and~     helps patients to live a better life. However, after the surgery, some patients have~     difficulty performing basic activities such as walking, or going up-down stairs, and the~     majority remains sedentary and gain weight. These combined problems leave patients at risk of~     worsening their health. Therefore, a treatment that takes care of all these combined problems~     is needed. We propose an all-inclusive treatment, called comprehensive behavioral~     intervention (CBI) that intends to improve the long-term effects of exercise programs. The~     CBI combines exercise program with promotion of physical activity, orientation on healthy~     nutrition, and an education approach that promotes self-initiative towards healthy habits.~     The overall aim of this proposed study is to test how patients post TKA will like the CBI~     program, how safe the program is, and adapt the program as needed for better acceptability.~     We believe the CBI will be safe, well tolerated, and will improve the ability of patients to~     perform physical tasks. We also believe the program will increase the amount of physical~     activity, will promote maintenance of healthy weight, and will help the patients to obtain~     and maintain healthy habits. In this study subjects will be selected by a flip of a coin to~     receive either our CBI program or a more traditional exercise program. Subjects will be~     tested before and after the treatments. Our measures of main interest are how well subjects~     move around and how physically active they are. We are also interested on the effect of the~     interventions on body weight, blood pressure, eating habits, and general health. The team of~     researchers for this study includes several disciplines. The proposed study will defend the~     need for a larger study that can have a very important impact on the public health of~     patients post TKA. The reason for the public health impact is if the physical limitations~     experiences by patients post TKA are left untreated, they tend to get worse. Furthermore, by~     increasing physical activity and promoting healthy weight, it may improve general health and~     prevent chronic diseases. Last, developing educational intervention that promotes~     self-initiative will result in long-term health benefits post TKA.~   "
135049|NCT01799603|"~     The purpose of this study is to investigate the effect of food on the pharmacokinetics~     (explores what the body does to the drug) and safety of TMC435 in Japanese healthy adult male~     participants.~   "
135050|NCT01799590|"~     The purpose of this study is to evaluate the safety and efficacy of topiramate in~     participants with migraine (type of severe headache that occurs periodically and is often~     associated with nausea, vomiting and constipation or diarrhea) who completed the~     JNS019-JPN-02 study.~   "
135051|NCT01799577|"~     This study tests the hypothesis that use of the 3-D laparoscopic vision system (Viking~     Systems, La Jolla, CA) can significantly improve technical ability on a complex laparoscopic~     tasks in an experimental model.~   "
135037|NCT01799759|"~     The proposed study is a continuation of a randomized, controlled pilot effectiveness trial~     conducted in schools wherein the feasibility and completion of the trial by parents and~     children will now additionally be examined in after school and YMCA connected programs.~      The intervention for this study is Project FUN and Project FUN with Parents. Project FUN is~     an 8 module online program for children in 4th through 8th grade. Project FUN with Parents is~     a 6 module online program for their parent.~      Children and parents will be recruited through the afterschool and YMCA connected programs.~     Those agreeing to participate will be randomly assigned to a first intervention or second~     intervention session (waiting list control group). Surveys and measures will be collected for~     everyone pre-intervention, after the first session completion and after the second session~     completion to create a waiting list control group.~      Hypothesis 1: Body composition and dietary fat of children who complete Project FUN and have~     a parent complete Project FUN with Parents will be lower on completion than children who only~     complete instruments.~      Hypothesis 2: Fruit and vegetable intake, physical activity and fitness of children who~     complete Project FUN and have a parent complete Project FUN with Parents will be greater on~     completion than children who only complete instruments.~   "
135038|NCT01799746|"~     In a controlled exposure setting, the study's goal is to determine the acute effect of diesel~     exhaust (DE) inhalation on airway inflammation and hyperresponsiveness (AHR) in subjects with~     mild to moderate stable asthma, using non-invasive measures.~   "
135039|NCT01799733|"~     The primary aim of this study is to examine the effects of co-administered wake therapy~     followed by light treatment on mood, and secondarily on circadian rhythms, to test the~     hypothesis that critically-timed chronotherapy improves mood by correcting phase disturbances~     in melatonin and sleep in women with Premenstrual Dysphoric Disorder.~   "
135040|NCT01799720|"~     The oxidation level of unsaturated fatty acid supplements commercialized in capsules could be~     a serious problem for manufacturers and a risk to consumers; health by ingesting substances~     whose effects are not desired. Therefore, the main objective of this paper is to analyze the~     effect of dietary supplements Omega-3 with different levels of oxidation in the lipid profile~     of women who consume these supplements. For this purpose the investigators have designed a~     single-blind, parallel-groups, randomized controlled trial. Finally, 52 women between 25 and~     75 years old were randomly distributed into three groups: (1) took 2 capsules/day of one of~     the less oxidized oil (containing 300 mg EPA + DHA) and diet, (2) took 2 capsules/day of one~     of the most oxidized oil (containing 300 mg EPA + DHA) and diet and (3) no capsules, only~     received the diet. There was a 30 days follow-up . All groups followed a low cholesterol~     diet. Circulating glucose, total cholesterol, triglycerides and glutamic pyruvic transaminase~     were determined at the beginning and end of a 30 day period.~   "
135041|NCT01799707|"~     Importance: Visual field loss after retinal damage in glaucoma is considered irreversible and~     methods are needed to achieve vision restoration. Behavioral vision restoration training~     (VRT), shown to improve visual fields in hemianopia and optic nerve damage, might comprise~     such a method.~      Objective: To determine if behaviorally activating areas of residual visual (ARV) using VRT~     by daily one hour training for 3 months improves detection performance in perimetry compared~     to a vision discrimination task in the intact visual field sector.~   "
135042|NCT01799694|"~     The purpose of this study is to evaluate the feasibility and security of the autologous e-ASC~     for the urinary incontinence after a radical prostate cancer surgery~   "
135043|NCT01799681|"~     To determine whether the 8-week Hopeful Outdoor Parkinson's Exercise (HOPE) Program would be~     effective in improving balance performance, physical functions, gait parameter, balance~     confidence, health-related quality-of-life, disease-specific motor performance and~     fall-related outcomes in Parkinson's disease (PD) non-fallers and single fallers.~   "
135044|NCT01799668|"~     The research will examine psychotherapists' preferences for theoretical client~     characteristics, such as age, gender, personality characteristics and symptoms. The research~     will also examine the preferences' influence on the therapeutic alliance, from the~     therapist's and the client's point of view.~   "
135045|NCT01799655|"~     Cardiovascular disease is the most common cause of mortality and morbidity worldwide.~     Recently, a growing body of evidence has identified Vitamin D deficiency as a potential risk~     factor for cardiovascular disease. Therefore, there is an increasing interest to explore the~     mechanism in which vitamin D deficiency affect the cardiovascular system.~      The investigators want to examine the relationship between serum vitamin D levels and the~     coagulation status in the subjects. The applied the calibrated automated thrombogram (CAT) to~     assess thrombin generation in plasma as a measure of overall thrombotic activity, and thus to~     suggest a mechanism that may explain the link between vitamin D deficiency and cardiovascular~     disease.~      Our study population are going to include 100 patients from the internal departments in Emek~     hospital, who present with chest pain but without acute coronary syndrome (ACS). The~     investigators will take blood samples from the subjects to measure the serum vitamin D levels~     and the generation of thrombin. The patients will be divided into four groups according to~     the level of vitamin D to evaluate the effect of vitamin D levels in the blood on~     coagulability and thrombotic activity in these patients.~   "
135046|NCT01799642|"~     Shortness of breath (dyspnea) during exercise is a major source of distress and is a commonly~     reported symptom in patients with cystic fibrosis (CF). Due to the investigators' poor~     understanding of how dyspnea develops, there are no treatments that consistently reduce~     dyspnea in this population. The investigators aim to acquire a more comprehensive~     understanding of the physiological mechanisms of exertional dyspnea in CF patients. This~     study will likely identify an important physiological mechanism of dyspnea in CF and may~     contribute to the development and use of effective treatments to reduce dyspnea in this~     population.~      The central hypothesis is that the impaired tidal volume (VT) response during exercise in CF,~     in the setting of increased ventilatory demand will give rise to different qualitative~     descriptions of exertional dyspnea compared with healthy age and sex-matched controls.~     Specifically, CF patients will select increased work and effort as their dominant~     descriptor of dyspnea up to the VT inflection/plateau. Beyond this point, CF patient's~     dominant descriptor will become unsatisfied inspiration. In contrast, healthy control~     participants will report increased work and effort throughout all phases of exercise and~     will not report unsatisfied inspiration, even after the VT inflection/plateau.~   "
135052|NCT01799564|"~     Geographic atrophy (GA) causes the loss of the retinal pigment epithelium (RPE) cells in~     broad areas of the retina. The application of subthreshold micropulse laser spots in healthy~     RPE in the vicinity of the area of GA may restore the imbalance in survival factors caused by~     the disease (ie, the laser may decrease vascular endothelial growth factor and RPE-derived~     transforming growth factor beta, upregulation of pigment epithelium-derived factor). This may~     slow or even stop the enlargement of atrophy secondary to GA, and therefore, avoid further~     vision loss.~   "
135053|NCT01799551|"~     Cognitive behaviour therapy (CBT) has an effective evidence base in the west and is~     recommended by the national bodies in many countries in the West. Our group has adapted CBT~     for depression and psychosis in Pakistan for use with local clients. Initial evaluations have~     found that these therapies are effective. However, due to the financial restraints it would~     be useful if the investigators find that brief version of the CBT might be applicable and~     effective in non western cultures. Therefore in this study, the investigators will be testing~     effectiveness of brief version of culturally adapted CBT for depression in a randomized~     controlled trial (RCT) in Pakistan.~   "
135054|NCT01799538|"~     Background:~      - Lymphangioleiomyomatosis (LAM) is a rare type of lung disease that occurs almost~     exclusively in women. In LAM, muscle tissue grows in the lungs and starts to block the flow~     of air. It is a progressive disease, and in severe cases may require a lung transplant. One~     possible treatment to improve breathing in people with LAM is inhaled albuterol. Albuterol~     can be given in a metered dose inhaler (MDI) or with a nebulizer. Researchers want to compare~     these methods to see which method best improves lung function in women with LAM.~      Objectives:~      - To see whether a nebulizer or MDI can better improve lung function in women with LAM.~      Eligibility:~      - Women at least 18 years of age who have impaired lung function because of LAM.~      Design:~        -  Participants will be screened with a physical exam and medical history. No lab tests~          will be needed for this study.~        -  Participants will have a 3-day overnight stay at the National Institutes of Health.~          Those who are using long-acting inhalers will have to stop taking these drugs 1 week~          before the study.~        -  Participants will receive either the nebulizer or two or four puffs of the inhaler. Four~          puffs of albuterol is a higher dose than is normally prescribed, and is being tested on~          this study.~        -  Participants will have each treatment around the same time of day on each of the 3 days.~          Before and after taking the albuterol, participants will have lung function tests.~   "
135055|NCT01799525|"~     Delayed cerebral vasospasm and secondary ischemic infarction are feared complications after~     aneurysmal subarachnoid hemorrhage (aSAH). To date, there is no effective therapy to prevent~     these ischemic complications. The arterial partial pressure of carbon dioxide (PaCO2) is one~     of the main determinants of cerebral blood flow (CBF) in healthy subjects. It is yet largely~     unknown, if and to what extent modulations of PaCO2 can influence CBF in patients after aSAH.~     The trial is a phase 1 study in which the feasibility of hypercapnia in SAH patients is~     tested. PaCO2 is gradually raised to 60 mmHg in 10 mechanically ventilated aSAH patients.~     Cerebral oxygen saturation measured by NIRS and CBF determined by an intracerebral~     thermodilution probe are the primary end points. If the feasibility is confirmed, this trial~     will be followed by a phase 2 dose finding study.~   "
135056|NCT01799512|"~     Stress hyperglycemia occurs in 50-85% of patients admitted to a medical intensive care unit~     (MICU) and is associated with increased morbidity and mortality. However, randomized~     controlled trials examining the effects of strict glycemic control demonstrated conflicting~     results. A common finding in these trials was the high risk of hypoglycaemia.~      This randomized controlled trial evaluates the impact of real-time continuous glucose~     monitoring (RT-CGM) on glycemic control and risk of hypoglycemia in severely ill MICU~     patients with an APACHE-II (Acute Physiology and Chronic Health Evaluation II) score ≥20.~   "
135057|NCT01799499|"~     This study is a prospective randomized open labeled dose ranging comparative study. Twenty~     four (24) patients with NMIBC who meet the inclusion/exclusion criteria will be recruited for~     the study following the initial diagnostic cystoscopy.~      The investigators believe that this study is of importance on several aspects:~        1. It evaluates a new mode of bladder instillation that may bypass the drawbacks of the~          current instillation mode.~        2. If proved effective, this mode of treatment might save the need for TURBT performance~          and serve as a new mode of tumor ablation.~        3. Even if proved partially effective, this mode of treatment will diminish tumors size~          and/or number, thus enable a more limited TURBT procedure.~        4. This mode of treatment will enable immediate medical attendance to the patient's tumor~          recurrence without the waiting period (resulting from queues in the medical centers) for~          TURBT. This might improve the patient's prognostic outcome.~        5. If this experimental treatment will prove to have a better ablative effect in comparison~          to the standard of care known in the art, this could be translated to a better~          prophylactic effect of tumor recurrence.~        6. Finding the minimal, yet optimal, effective dose for tumor ablation and tumor recurrence~          prevention will enable us to reduce adverse effects of higher drug dosage.~   "
135058|NCT01799486|"~     Chronic hepatitis B virus (HBV) infection is a serious clinical problem because of its~     worldwide distribution and potential adverse outcome, including cirrhosis, which is a major~     cause of HBV related death. Studies show the use of nucleot(s)ide analogs treatment can~     alleviate, even reverse the progress of HBV-related cirrhosis. In cirrhosis stage, some~     potential factors, including endocrine disorder, renin, aldosterone, vasopressin increasing,~     hepatitis B virus related nephritis, hepatorenal syndrome, may cause renal damage. With the~     exposure of NAs, adverse reports of rhabdomyolysis, renal dysfunction, and lactic acidosis~     are increasing. So when choosing NAs, the potential renal function impairment should be~     considered.~      Recently, Gane, Xiaoxi Li have separately reported that Telbivudine can improve estimate of~     glomerular filtration rate (eGFR) of patients with chronic hepatitis B, while eGFR of~     patients with Lamivudine, adefovir and entecavir have a trend of decrease, which suggested~     Telbivudine may have renal protective effects. This effect on patients with HBV-related liver~     cirrhosis has not been studied, which is not clear now.~      This study is a randomized controlled study to prospectively observe Telbivudine's effect on~     renal function, which aims to provide evidence in antiviral treatment for the patients with~     cirrhosis.~   "
135059|NCT01799473|"~     This prospective, observational, multi-center, patient registry will follow patients who are~     newly initiated on Tyvaso for the treatment of Pulmonary Arterial Hypertension (PAH). Once~     enrolled, the patients' dose and titration will be followed for the first 6 months of~     treatment with Tyvaso.~      A call-center will contact the patients directly at weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24~     to review their dose and titration schedule. In addition to patient-reported dosing data,~     some patient demographic information, will be collected by the investigative site at~     Baseline.~   "
135060|NCT01799460|"~     The purpose of this study is to analysis the different genotype in the idiopathic membranous~     nephropathy patients which with different therapeutic outcomes after treated by the~     Comprehensive Treatment Regimen or immunosuppressive agents, and so as to looking for ideal~     markers to assess appropriate treatment approach and the long-term efficacy.~   "
135061|NCT01799447|"~     Early intervention with the Marte Meo method. Aim to study whether the program have effect~     on:~      Maternal confidence, maternal stress, maternal mood (EPDS), dyadic synchrony (Infant care~     index), and infants social competences (ASQ:SE)~   "
135062|NCT01799434|"~     The aim was to analyze the influence of fatigue on the dynamic postural control in one-leg~     standing and in jump landing, followed by stabilization or side jumps, and to compare~     athletes of different levels with control subjects.~   "
135063|NCT01799421|"~     The purpose of this study is to identify prognostic factors and to develop predictive models~     of risk of febrile neutropenia and neutropenia grade 3/4 in patients with solid tumors~     receiving chemotherapy with schemas that have an inherent risk of febrile neutropenia of~     10-20%.~   "
135064|NCT01799408|"~     To evaluate the effect of intra-articular corticosteroid injection (IACI) of depot~     preparation of betamethasone on the hypothalamic-pituitary-adrenal (HPA) axis, in patients~     with osteoarthritis of the knee~   "
135065|NCT01799395|"~     Lung cancer may cause central airway obstruction through several different mechanisms~     (invasion by the primary tumor, invasion by metastatic lymph nodes, airway metastasis).~      The aim of the present study is to determine the prevalence at the time of diagnosis, the~     incidence at 1 year from the diagnosis, and the predictors of central airway obstruction~     associated with advanced lung cancer.~   "
135066|NCT01799382|"~     The purpose of the study is to determine if rapid on-site evaluation of EBUS-TBNA samples can~     increase the percentage of patients with advanced non-squamous non-small cell lung cancer in~     whom both pathologic subtyping and mutational analysis are obtained.~   "
135067|NCT01799369|"~     Background Surgeons lack a routine, objective evaluation of patient condition after surgery.~     We currently rely on subjective assessment of available patient data. The current scoring~     methods such as Acute Physiology and Chronic Health Evaluation and Physiological and~     Operative Severity Score for the enUmeration of Mortality and morbidity are complex and~     cumbersome and have therefore not been adopted into routine practice.~      The Surgical Apgar Score (SAS) is a simple score on a scale of 0 to 10 calculated from 3~     parameters collected during the operation: lowest heart rate, lowest blood pressure,~     estimated blood loss (Regenbogen et al., Arch Surg 2009).~      Previous validation studies have shown a good correlation between the score and incidence of~     major complications or death occurring within 30 days. For example, 75% patients with a score~     of 0-2 had major complications, whereas it was only 5% in those with a score of 9-10. To~     date, the SAS has never been clinically applied and tested in a trial.~      We believe that routine use of the SAS will lead to a reduction in major complications and~     deaths after surgery. We also believe that it will lead to a reduction in the severity of the~     complications.~      This is based on our theory that the SAS eliminates the guesswork. Using this score will add~     objectivity and clarity to clinical decisions that are presently based on clinical instinct~     or 'gut feeling'. The score will more clearly highlight those patients who are at an~     increased risk of developing complications or dying and will flag them up for increased~     monitoring, a higher index of clinical suspicion and a lower threshold for early management~     of problems.~      Primary Aim The primary aim of the pilot is to strengthen the design and assess the~     feasibility of the main study on the SAS. We aim to recruit 100 patients in each group, 200~     in total. The primary aim of the main study will be to establish if clinical application of~     the SAS leads to a reduction in 30-day post-operative morbidity and mortality.~      Study Design The design of this pilot is the same as what the main trial will eventually be:~     a multicentre single-blind randomised controlled trial (RCT). Current data suggests the~     overall expected major complication or death rate in our target population would be 21%. The~     sample size of the future RCT is therefore estimated to be 986 each group to detect a 5%~     reduction in complications (Significance 0.05%, Power 80%).~      Outcomes Our primary outcome will be major complications or death within 30 days of~     operation. Our secondary outcomes (all within 30 days of operation) will be minor~     complications, primary and secondary critical care admissions and length of stay, duration of~     therapeutic antibiotics, number of additional operations under general anaesthetic to treat~     complications, and overall length of stay.~   "
135068|NCT01799356|"~     We aimed to compare efficacy and safety of combination therapy with oral ofloxacin, 400 mg~     twice daily, plus oral metronidazole, 500 mg twice daily, for 14 days, with moxifloxacin~     monotherapy, 400 mg once daily, for 14 days~   "
135069|NCT01799343|"~     Pregnant women with pre-eclampsia and growth restricted fetuses often have a reduced function~     of the placenta. This is accompanied by an increased perinatal mortality and morbidity.~      By ultrasound it is possible to measure blood flow and vascular resistance in both the fetal~     umbilical cord and in the blood vessels supplying the uterus. A high resistance in these~     vessels occur before the child is severely affected.~      By immersion in water extracellular fluid is redistributed back into the circulation, and~     central blood volume increases. Previous studies have shown that maternal minute-volume~     increases, while blood pressure drops slightly. Also an increased amniotic fluid has been~     recorded. This has been interpreted as an expression of increased renal blood flow. Immersion~     into water could increase blood flow in the vessels supplying the uterus and thus increase~     blood flow to the child.~      The investigators aim to clarify this by examining blood flow and resistance in the blood~     vessel supplying the uterus and in the umbilical cord, while the participant is immersed into~     water. Initially, 25 healthy women with an uncomplicated singleton pregnancy recruited from~     the Department of Obstetrics and Gynaecology: Hvidovre University Hospital, Denmark, will be~     examined. The participant will act as its own control and measurements above water and~     immersed will be conducted at the same study session.~      Ultimately the investigators seek to contribute to a non-invasive option for prolonging those~     pregnancies where the fetus and/or maternal condition requires delivery several weeks before~     term, and where immersion of the pregnant woman in the water a few hours one to several times~     daily, may prolong the pregnancy the required number of hours/days for antenatal steroid~     treatment to be sufficient.~      There are no risks associated with the study and the project team considers it ethical to~     implement this. The study is not supported by pharmaceutical companies or other groups with~     economic interests. The project group itself has taken the initiative to study.~   "
135070|NCT01799330|"~     The two hypotheses to be tested in this study are that:~        1. The administration of transcutaneous electrical muscle stimulation (TCEMS) after~          completion of conventional exercise training in pulmonary rehabilitation (PR) will~          result in further improvements in exercise tolerance, functional status and symptoms of~          patients with stable chronic obstructive pulmonary disease (COPD) above those achieved~          in PR alone.~        2. TCEMS can improve exercise tolerance, functional status and symptoms even among COPD~          patients who fail to make gains in exercise tolerance by participating in conventional~          PR due to their debilitation and/or marked cardio-respiratory impairment.~   "
135268|NCT01796730|"~     This is a randomized, double-blind, 3-crossover trial with a 7-days washout baseline period~     followed by three treatment periods of 21-days each performed in patients with COPD. Patients~     will be randomized to receive three treatments (bambuterol 10mg, bambuterol 5 mg and~     placebo).~   "
135071|NCT01799317|"~     The study outlined is designed to measure and to determine whether the combined use of~     vitamin D2 (ergocalciferoI) and 1-alpha-hydroxyvitamin D2 (doxercalciferol)) or~     doxercalciferol alone will correct the mineralization defect in pediatric patients with~     established secondary hyperparathyroidism (2°HPT) undergoing regular peritoneal dialysis.~     Serum phosphorus levels will be controlled with a calcium¬-free-metal free phosphate binder;~     (obtained at baseline and after 8 months of treatment) sevelamer. Indices of bone~     mineralization obtained at baseline and after 8 months of treatment will be measured by~     quantitative histomorphometry in iliac crest bone biopsies after double tetracycline~     labeling. Immunohistochemistry will be done in specimens of bone biopsies from iliac crest to~     examine the expression for selected markers of bone turnover and mineralization such as~     FGF-23, DMP1, MEPE and OPG. Serum PTH levels will be measured with the 1st and 2nd generation~     immunometric assay (PTH-IMAs) and fibroblast growth factor-23 (FGF-23) will be determined by~     one assay with specific detection antibodies that are against epitopes within the C-terminus~     of FGF-23 and another assay that uses antibodies against epitopes within the N- and~     C-terminal portions of the molecule respectively. The value of non-invasive assessment of~     bone mass by quantitative computed tomography (QCT) and its relationship with vascular~     disease determined by ultrasound (US) of intimal carotid thickness (CIMT) will be correlated~     with bone histomorphometry and the different biochemical determinations.~   "
135072|NCT01799304|"~     Cerebral palsy (CP) concerns 2 children out of 1000 in the general population (SCPE 2002). It~     is the main cause of postural and motor deficits in children.~      During the past 20 years, the postural deficits exhibited by these children have been~     attributed to various factors :~        1. neuromuscular functions~        2. sensory integration~        3. muscular-squeletic functions.~      The common point of all these studies is the existence of immature motor patterns, probably~     related to an inability to implement more elaborated and adapted motor patterns with respect~     the task to perform.~      CP children do not develop the characteristics of the plant grad locomotion. They exhibit a~     uniform muscular activation with a high level of co-activation. Locomotion is generally~     characterized by an increase of stretching reflexes at short latencies and by a low level of~     activation associated to a low modulation of gastrocnemius muscles..~      These data also suggest that it is the control of the temporal rather than the spatial~     parameters of the head which are mainly altered in CP children.~      Even though static postural control and locomotion are considered as automatic processes,~     this control requires, however, a significant amount of attentional resources.~      Within this context, the amount of attentional resources which need to be solicited can~     provide information on two complementary dimensions. On one hand, on the level of~     automaticity of postural control and/or locomotion when subjects' attention is oriented~     toward another task. On the other hand, on the cognitive cost of postural control and/or~     locomotion, depending on children age, that is, as a function of their level of maturation~     and of the nature and importance of their sensory-motor deficits. When the amount of required~     attentional resources is reduced, postural control and/or locomotion is considered as~     automatic processes with a low cognitive cost.~      The dual task paradigm in which subjects have to simultaneously process a cognitive (e.g.~     Stroop task) and a postural or motor task (e.g., standing upright on a force platform) is~     generally used to investigate these questions.~      How an appropriate allocation of attention is performed as a function of the cognitive and~     postural/motor tasks is important in the developmental process of posture and locomotion. It~     seems to be even more crucial in CP children and more generally in pathology.~      The main goal of the present project is to investigate the contribution of attentional~     processes in postural control and locomotion of CP children as compared to control healthy~     children.~   "
135073|NCT01799291|"~     The primary aim is to test the efficacy of a new intervention to improve clinical judgment.~     The investigators focus on the assessment of pediatric bipolar disorder (PBD), a~     controversial diagnosis with frequent diagnostic errors, by educating mental health~     professionals in common cognitive pitfalls and training them in recommended de-biasing~     strategies. The investigators hypothesize that the Treatment group will show higher~     diagnostic accuracy than the Control condition: Participants receiving the cognitive~     de-biasing intervention will be less likely to commit faulty heuristics and race/ethnicity~     bias. Secondary aims include soliciting feedback about whether the skills were useful when~     diagnosing the vignettes, and whether skills and cases seem clinically realistic.~   "
135074|NCT01799278|"~     This study will evaluate the response rate of MLN8237 in patients with histologically~     confirmed or clinically suspected metastatic neuroendocrine prostate cancer (NEPC). MLN8237~     is an orally administered Aurora kinase A inhibitor that has demonstrated broad antitumor~     activity in vitro and in vivo. In preclinical models, aurora kinase inhibition resulted in~     dramatic and preferential anti-tumor activity in NEPC with suppression of neuroendocrine~     marker expression.~   "
135075|NCT01799265|"~     The purpose of this study is to determine whether the Transcend Auto is as effective in~     treating obstructive sleep apnea as another device that is already on the market.~   "
135076|NCT01799252|"~     The effectiveness of antibiotic treatment at reducing post-abortion infection is unclear. The~     experiences of women prescribed routine antibiotics after medical abortion is missing from~     the existing evidence. This study seeks to add to the literature evidence of the side effects~     associated with antibiotic treatment that women experience and their adherence to prescribed~     regimens.~   "
135077|NCT01799239|"~     The aim of the current investigation is to evaluate the combination of an adhesive with a~     soft top film.~   "
135078|NCT01799226|"~     This study evaluates the anti-inflammatory effects of Colgate Total® during an experimental~     gingivitis model developed by Löe et al. Half of the participants will use Colgate Total®~     (which contains triclosan), while the other half will use a toothpaste which does not contain~     triclosan as the control.~   "
135079|NCT01799213|"~     Knee osteoarthritis (OA) is now recognized as a major health problem. It is the number one~     cause of lower extremity disability and has significant deleterious effects on quality of~     life. While there are numerous therapies available for knee OA, most have limited efficacy.~     Of particular concern, is the widespread use of nonsteroidal anti-inflammatory drugs (NSAIDs)~     for this disorder. Veterans, as a group, are at high risk for both gastrointestinal and~     cardiovascular NSAID-induced complications. In this study the investigators propose to~     examine whether replacing NSAIDs with cognitive behavioral therapy delivered by telephone is~     an effective strategy for Veterans with knee OA. Telephone-administered therapy is~     particularly appealing since Veterans with knee OA are more likely to have limited mobility.~     If successful, this program may result in significant cost-savings for both Veterans~     (decreased co-pays and transportation costs) and the VA (decreased hospitalizations due to~     NSAID induced toxicity).~   "
135088|NCT01799096|"~     This study partially replicates two previous studies with normal weight women, and overweight~     women. Both found that women could compensate for sucrose added to the diet in carbonated~     soft drinks (4 x250ml total1800 kJ per day) when it was given blind over a period of 4 weeks.~     The hypothesis is that this applies also to obese women, who will not gain weight, increase~     overall energy intake in the diet, or eat differently whilst consuming sucrose. 42~     participants shall be randomly assigned to either be given carbonated drinks that contain~     sucrose, or drinks that are artificially sweetened.~   "
135080|NCT01799200|"~     The primary objective of this study is to investigate factors hypothesized to influence the~     prevalence of hip pathomorphology (femoroacetabular impingement, dysplasia) in young adults.~     To complete this objective, we will quantify the prevalence of radiographic measures~     indicative of hip pathomorphology in collegiate athletes and age-matched controls. This data~     will allow us to test our main hypothesis, that the prevalence of hip pathomorphology is~     higher in collegiate athletes than age-matched controls. To further elucidate the factors~     which may increase the prevalence of hip pathomorphology, we will correlate the radiographic~     measures to sport involvement history, hip function and demographics, as collected by means~     of a questionnaire.~      The secondary objective of this study is to determine if physical exams (range of motion,~     impingement test) could be used to screen for radiographic measures of hip pathomorphology in~     athletes and age-matched controls. To complete this objective, we will correlate range~     physical exam results to the radiographic measures and determine each exam's sensitivity and~     specificity to detect abnormal morphology.~   "
135081|NCT01799187|"~     Revascularization is an alternative new treatment of immature permanent teeth with necrotic~     pulp nowadays while apexification is the traditional therapy. The investigators suppose that~     revascularization is superior to apexification at developing the root of immature permanent~     teeth and reducing the risk of root fracture,and the research is designed.~   "
135082|NCT01799174|"~     This is a randomized, blinded, and controlled trial to assess the efficacy and safety of UVA1~     phototherapy in the treatment of active morphea in adults and children. Forty patients will~     be randomized to receive either medium dose (70 J/cm2) phototherapy (active UVA1~     phototherapy) with an ultraviolet translucent acrylic screen or sham UVA1 (0 J/cm2)~     phototherapy with an ultraviolet opaque acrylic screen 3 times per week for 10 weeks. The~     phototherapists, patients, and principal investigator will be blinded to whether the patients~     receive active or sham UVA1 phototherapy. Patients will only be allowed to apply emollients~     during the study.~      Patients completing the randomized placebo controlled trial (RPCT) will be followed during an~     open observation period for 3 months. During the open phase, all outcome measures from the~     RPCT (LoSSI, PGA-A) will be assessed every 5 weeks as well as adverse events. Patients who~     received sham UVA1 phototherapy will be invited to receive active UVA1 phototherapy using the~     same protocol as in the RPCT during the open observation. Adult patients enrolled in the RPCT~     will also be part of a nested translational study investigating the effect of UVA1~     phototherapy on gene expression from whole skin biopsies taken before (Study Visit 1) and~     after UVA1 phototherapy (Study Visit 3). Gene expression profiles will be compared in~     lesional skin before and after treatment as well as nonlesional skin.~   "
135083|NCT01799161|"~     NSCLC tumors are appropriate targets for active immunotherapy, because they are~     non-immunogenic, which indicates that NSCLC does not stimulate a spontaneous immune response.~      NSCLC tumor-secreted gp96-Ig is an ideal vaccine because it combines adjuvant activity with~     polyvalent peptide specificity. Tumor secreted gp96 activates dendritic cells (DC), natural~     killer cells (NK) and cytotoxic T lymphocytes (CTL). Tumor cells can be killed by NK-specific~     mechanisms, by promiscuous killing of CD8 CTL through NKG2D, and by MHC restricted CD8 CTL~     activity. The activation of DC and NK by tumor secreted gp96 may also counteract the~     generation of immuno-suppressive CD4 regulatory cells.~      Suppression of adenosinergic pathways by oxygen and theophylline in combination with~     immunotherapy will improve tumor rejection.~      Allogeneic, gp96-Ig secreting tumor cells used as vaccine are expected to generate NK and CTL~     with activity to the patient's autologous tumor.~   "
135084|NCT01799148|"~     The objectives of this study are: 1) To determine whether patients with acute coronary~     syndrome, the level of environmental exposure to particulate air pollutants in the week prior~     to admission, are related to concentrations of inflammatory molecules and oxidative stress.~     2) To investigate whether the level of environmental exposure is an independent prognostic~     factor in terms of overall and cardiovascular mortality, myocardial infarction or unstable~     angina at 30 days, 6 and 12 months.~   "
135085|NCT01799135|"~     This is a pilot study. A pilot study is done with a small number of participants to see if a~     technique works before using it in a larger research study. This pilot study is evaluating a~     special kind of MRI scan of the lungs called dynamic contrast enhanced MRI (DCE-MRI).~      DCE-MRI can demonstrate how much blood flows through the tumor and lungs and tell us how~     active the tumor is, as well as how functional the lungs are. As part of this scan,~     participants will receive an intravenous (into the blood via puncture of a vein) injection of~     gadolinium contrast, a dye that helps us see the tumor and lung tissue more clearly.~     Gadolinium is approved by the FDA and is routinely used for MRI.~      The goal of the study is to determine whether DCE-MRI can provide images of the response of~     the tumor and the normal lung tissue to SBRT and to potentially hep improve~     treatment-planning methods for patients treated with SBRT in the future. We will also study~     how the final DCE-MRI scan compares with another form of imaging, called 4-dimensional~     computed tomography (4D-CT), that looks at the breathing capacity of the lungs. Although we~     are researching the usefulness of DCE-MRI in early stage non-small cell lung cancer treated~     with SBRT in this study, DCE-MRI with the dye injection is not an experimental technology and~     is routinely used in the clinic for other indications. The 4D-CT scan is also not~     experimental and is used for radiation planning and imaging of the lungs.~      The SBRT you will receive will be standard treatment and will not be affected by your~     participation in this study or by these DCE-MRI scans. That means that the findings on the~     scan will not be used to alter your planned treatment in any way. Additionally, participants~     will undergo the routine work-up prior to SBRT and surveillance studies after treatment is~     complete.~   "
135086|NCT01799122|"~     Randomized comparison of two surgeries for the treatment of female stress urinary~     incontinence.~   "
135087|NCT01799109|"~     Asthma is a common chronic respiratory illness which results in frequent wheezing,~     cough,reduced quality of life. Standard treatment for asthma attack includes oxygen therapy,~     β2-agonists (e.g. albuterol) and inhaled anticholinergics and corticosteroids. Although~     inhaled short-acting β2-agonists (SAB) is the initial choice to control acute asthma~     exacerbation, there are still some asthmatic children unresponsive to this management. The~     Global Initiative in National Asthma (GINA) does not recommend intravenous magnesium sulfate~     (MgSO4) for routine use in asthma exacerbation especially in young children. But intravenous~     MgSO4 can reduce hospital admission rates in certain patients due to several effects e.g~     relaxation of smooth muscle,blocking acetylcholine. In addition,adding MgSO4 to nebulized SAB~     provides greater benefit in severe asthma exacerbation.~   "
135090|NCT01799070|"~     Background: Cerebral hyperperfusion syndrome (CHS) is a life threatening complication of~     carotid endarterectomy (CEA) and the changes of middle cerebral artery velocity are used to~     predict the occurrence of CHS but the accuracy is limited. In addition, changes of BP~     post-operatively comparing with baseline BP should be a predictive factor of CHS.~      Objective: The investigators aimed to create a predictive index, velocity systolic blood~     pressure index (VSI), for improving the predictive power of Transcranial Doppler monitoring~     regarding CHS.~      Methods: The study design is a diagnostic test, which is an observational analytic clinical~     study. From March 2013 to September 2014, 200 patients will be recruited. Patients will be~     classified according to the CHS occurrence. VSI combined the changes of middle cerebral~     artery velocity and blood pressure crossing CEA and the intra- and post-operative increase~     ratios of middle cerebral artery velocity were calculated. Their prediction power of CHS will~     be compared. Sensitivity, specificity, positive predictive value, negative predictive value~     of them will be calculated. Receiver operating characteristic analysis will be performed.~      Expected Outcomes: Comparing with the commonly used intra-operative and post-operative TCD~     monitoring, VSI may be more useful to select CHS in patients who underwent CEA. As far as the~     investigators know, analysis or studies combining the BP and velocity changes in the~     prediction of CHS have never been performed.~   "
135091|NCT01799057|"~     The purpose of this study is to determine the effects of metformin on functional capacity~     (pain-free and maximum walking times) in individuals with peripheral artery disease~     (PAD)-related intermittent claudication.~   "
135092|NCT01799044|"~     Irreversible electroporation is a new, minimal-invasive image-guided treatment to treat~     tumors near or around vulnerable structures, such as central liver tumors.~      To investigate the safety and efficacy of IRE in the treatment of colorectal liver~     metastases, patients with resectable colorectal liver metastases undergo IRE and resection of~     the metastases in the same session. After resection, the specimen is examined macroscopically~     to determine vitality using a specific vitality staining (triphenyl-tetrazoliumchloride) and~     to visualize the exact ablation zone. Subsequently, histopathologic examination is used to~     determine type of cell death and the microscopic ablation zone.~      The investigators hypothesize that IRE is a safe effective method to treat colorectal liver~     metastasis and that cell damage and cell death is demonstrated as soon as 1 hour after the~     procedure.~   "
135093|NCT01799031|"~     This randomized clinical trial studies an educational intervention for reducing work~     disability in breast cancer survivors. Web sites providing symptom management education may~     be an effective method to help breast cancer survivors reduce work disability after treatment~   "
135094|NCT01799018|"~     The purpose of this study is to determine the role of Proteomics and Metallomics in Cerebral~     Vasospasm following Subarachnoid Hemorrhage~   "
135095|NCT01799005|"~     Atherosclerosis progressively occurs with increasing age in the general population. So far~     most dietary intervention studies with flavanols were performed over short time frames and in~     small groups of young healthy and older patients with manifest cardiovascular disease,~     respectively. Vascular health is defined as absence of vascular disease and the presence of~     optimal parameters that determine the development and progression of arteriosclerosis~     (endothelial function, blood pressure, plasma lipids, and glucose). It is not clear whether~     flavanols can improve parameters of vascular health, most importantly endothelial function,~     when given repetitively to healthy middle aged and which factors affect the efficacy of~     flavanol interventions.~   "
135096|NCT01798992|"~     The primary goal of the study is to measure in the intact human heart, the alterations in~     gene expression over time that are associated with reverse remodeling in response to~     β-blockade. The second goal is to investigate the signaling mechanisms which in turn are~     responsible for these changes in gene expression, and the third goal is to determine the~     relationship between intrinsic systolic dysfunction and remodeling of the left ventricle.~     This will be accomplished by measuring ventricular size, function, and gene expression in~     myocardial tissue samples obtained by percutaneous biopsy prior to initiation of β-blockade~     and at 3 and 12 months after start of therapy. The specific Aims and Hypotheses to be tested~     are:~        1. Aim: Determine the changes in gene expression associated with changes in intrinsic~          systolic function and with functional decompensation in the intact, failing human heart.~           a. Hypothesis: Changes in the expression of select genes precede or accompany changes in~          left ventricular systolic function in humans with idiopathic dilated cardiomyopathy~          (IDC).~        2. Aim: Identify signaling mechanisms responsible for alterations in expression of key~          genes involved in mediation of ventricular hypertrophy or contractile dysfunction.~           a. Hypothesis: Myocardial-failure-associated regulation of select messenger ribonucleic~          acids and proteins are related to left ventricular wall stress and neurohormonal~          signaling.~        3. Aim: In the relationship between contractile dysfunction and dilatation/remodeling,~          determine the relationship between contractile dysfunction and structural remodeling.~           b. Hypothesis: the contractile dysfunction is primary and structural remodeling~          secondary.~   "
135097|NCT01798979|"~     This will be a drug-drug interaction study to evaluate the effect of multiple oral doses of~     GLPG0634 on the single dose pharmacokinetic profile of midazolam administered in fasted~     normal healthy males. Each subject will receive a single oral dose of midazolam (2 mg) on 2~     occasions: on Day 1, before dosing with GLPG0634 and on Day 8, after multiple oral doses of~     GLPG0634 (daily for 7 days).~      Also, the safety and tolerability of multiple oral doses of GLPG0634 co-administered with~     midazolam in healthy male subjects will be evaluated.~   "
135109|NCT01798823|"~     The goal of the project is to define the prevalence and inflammatory background of~     exercise-induced bronchoconstriction (EIB) in school children and determine individual and~     environmental risk factors for EIB. The obtained results will provide objective measures on~     biological processes leading to bronchoconstriction during exercise, as might be experienced~     naturally during the school life. The results could be applied in the management of EIB~     patients with or without asthma. The results of planned research will be published in~     journals with national and international impact, and presented during symposia and~     conferences.~   "
135110|NCT01798810|"~     The OXYGEN Study is a double blinded prospective randomized controlled trial that will~     compare the proportion of surgical site infections within 6 months in patients treated with~     Supplemental Perioperative Oxygen compared to those treated without Supplemental~     Perioperative Oxygen.~   "
135098|NCT01798966|"~     Patients with Thyroid Eye Disease (TED) often have enlarged extraocular muscles and higher~     orbital fat contents due to their disease process. The confined space of the orbit cannot~     hold the enlarged orbital contents creating a forward displacement and/or compression of the~     globe with a rise in intraocular pressure (IOP). Many of these patients undergo surgical~     decompression, a procedure that fractures orbital bones, in order to allow more space for the~     enlarged orbital contents to occupy. To date, there is no data that shows intraocular~     patterns over a 24-hour period in patients with mechanical compression on the globe as in~     TED. It is not know if the pattern of IOP is more consistent with normal IOP patterns,~     glaucomatous patterns, or perhaps completely different then either. The goal of this project~     is to investigate patterns of IOP in patients requiring orbital decompression because of~     orbital congestion. Changes in IOP during a 24-hour period will be studied with a~     contact-lens embedded sensor that provides continuous data. This device has previously been~     investigated and shown to be safe and well-tolerated. Monitoring the pattern in these~     patients will allow us to compare Thyroid TED patterns of IOP with those of normal and~     glaucomatous patients. Also, testing these patients before and after orbital decompression~     surgery will allow characterization of how intraocular pressure changes once the mechanical~     compression on the globe is relieved.~   "
135099|NCT01798953|"~     Primary sclerosing cholangitis (PSC) occurs in approximately 10 % of patients with ulcerative~     colitis (UC), but the outcome of reconstructive surgery is not clear. The purpose of this~     study was to determine the functional outcome after surgery, frequency of pouchitis,~     complications and failure-rate in UC-PSC patients compared to patients with UC alone. Both~     ileal pouch-anal anastomosis (IPAA) and ileo-rectal anastomosis (IRA) were studied.~   "
135100|NCT01798940|"~     Objective:~      subjects to compare the single dose bioavailability of Torrent's Pioglitazone Hydrochloride~     Tablets 1 × 45 mg and Actos® Tablets 1 × 45 mg of Takeda Pharmaceuticals America, Inc. Dosing~     periods of studies were separated by a washout period of 12 days and 11 days respectively.~      Study Design:~      Randomized, Two-Way Crossover, Single-Dose, and Open-Label~   "
135101|NCT01798927|"~     The purpose of this study is to investigate the impact of a specifically designed ankle foot~     orthosis (AFO, hinged, with Tamarack joint and adjustable check strap) on the spatial and~     temporal gait parameters, electromyography (EMG) and walking endurance, in select individuals~     living with Parkinson's disease.~   "
135102|NCT01798914|"~     The purpose of this study is to allow patients with specific needs for inhaled insulin to~     continue with inhaled insulin therapy using Technosphere Insulin after Exubera was withdrawn~     from the market.~   "
135103|NCT01798901|"~     This phase I trial studies the side effects and best dose of AR-42 when given together with~     decitabine in treating patients with acute myeloid leukemia. AR-42 may stop the growth of~     cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells,~     either by killing the cells or by stopping them from dividing. Giving AR-42 together with~     decitabine may kill more cancer cells.~   "
135104|NCT01798888|"~     Background:~      - Current treatments for alcoholism have limited success. More than half of people with~     alcoholism return to uncontrolled drinking even after treatment or self-help programs. One~     possible treatment is the use of deep brain stimulation (DBS). DBS studies of the ventral~     capsule/ventral striatum, a region of the brain, reduced cravings for alcohol in a small~     group of alcoholics. DBS is approved for treating other disorders, such as Parkinson s~     disease, but not for treating alcoholism. Researchers want to study whether DBS can be used~     to treat chronic alcoholism.~      Objectives:~      - To see if deep brain stimulation is helpful and safe for people who have chronic~     alcoholism.~      Eligibility:~        -  Individuals between 21 and 60 years of age who have been diagnosed with chronic~          alcoholism.~        -  Participants must have tried for more than 10 years to stop drinking alcohol, and have~          failed multiple treatment and self-help programs. They may not have any other current~          substance abuse or dependence problem (except alcohol and nicotine).~      Design:~        -  Participants will start the study by entering a separate alcohol detoxification study at~          the National Institutes of Health. They will be monitored during this study with blood~          tests and brain scans.~        -  Participants will have 2 weeks of baseline tests. They will include physical exams and~          blood and urine tests. They will also include tests of thinking and memory, and~          questions about current moods.~        -  Participants will have surgery to insert the DBS device. Electrodes will be placed in~          the brain and a battery pack will be placed in the chest. Participants will recover from~          the surgery and continue the alcohol detoxification program.~        -  About 4 weeks after surgery, participants will be separated into two groups. For one~          group, the DBS device will be turned on with electrical stimulation and participants~          will be monitored for an additional two weeks in the hospital to find the right setting~          for the device. For the second group, participants will receive mock stimulation, but no~          real electrical DBS, and will also be monitored for an additional two weeks in the~          hospital.~        -  Participants will return home for 24 weeks. During this time they will have frequent~          study visits to look at the DBS device. These visits will include questions about mood~          and memory, as well as imaging studies.~        -  All participants will return for an additional two week inpatient stay in the hospital.~          Those participant who had initially received mock stimulation will now have their~          devices turned on with real electrical stimulation and will be monitored for the two~          weeks to find the right setting for the device. Those participants who had initially~          received real stimulation will continue to receive stimulation while being monitored for~          the two weeks.~        -  Participants will return home for another 24. All participants at this point will have~          actual electrical DBS. Participants will continue to have frequent study visits for up~          to a year to look at the DBS device. These visits will also include questions about mood~          levels and alcohol cravings.~   "
135105|NCT01798875|"~     In addition to chronic anovulation and hyperandrogenemia, polycystic ovary syndrome (PCOS) is~     also characterized by peripheral insulin resistance and hyperinsulinaemia, which in turn lead~     to the development of diabetes, hypertension, atherosclerosis and coronary heart disease.~     Serum markers of inflammation are being increasingly recognized as predictors of~     atherosclerosis and cardiovascular risk, and chronic low-grade inflammation has been recently~     proposed to play a role in the pathogenesis of metabolic syndrome and type 2 diabetes~     mellitus. Therefore, the aim of the present study is to evaluate the effects of commonly used~     non-pharmacologic (diet and lifestyle change) and pharmacologic (oral contraceptives,~     metformin, anti-androgens) treatment strategies on classical and surrogate cardiovascular~     risk markers in women with PCOS. The study hypothesis is that some of the commonly used~     therapies of women with PCOS may have more favorable effects on classical and surrogate~     markers of cardiovascular risk then others or some of them may even confer a higher risk of~     cardiovascular events~   "
135106|NCT01798862|"~     The iatrogenic induction of local endometrial injury caused through hysteroscopy or pipelle~     sampling in the preceding non- transfer cycle improves the IVF outcome parameters in patients~     with previous IVF failures.~   "
135107|NCT01798849|"~     This study will evaluate safety, tolerability and effects on central diastolic blood pressure~     (cDBP) of MK-8892 given as single oral doses in healthy male participants (Panel A and B) and~     in male participants with mild-to-moderate hypertension (Panel C).~   "
135108|NCT01798836|"~     To evaluate the effect of oestradiol pre-treatment in a combined ultrashort flare GnRH~     agonist /GnRH antagonist protocol~   "
135111|NCT01798797|"~     A prospective post-market study to evaluate the performance and clinic usability of heart~     failure risk status (HFRS) feature on CareLink.~   "
135112|NCT01798784|"~     In a 4-arm, Randomized Control Trial among members of CVS Caremark or Penn Medicine Patients~     with suboptimal cholesterol control who are at high risk for CVD, the study investigators~     propose to test the effectiveness of different behavioral economic techniques in inducing~     habit formation for adherence to statin use and sustained reductions in LDL cholesterol after~     financial incentives are discontinued. Primary outcome is changes in LDL from enrollment to~     12 months (6 months after cessation of financial incentives).~   "
135113|NCT01798771|"~     The investigators hypothesize that the rate of radiologically complete resections of~     contrast-enhancing brain tumors following surgeries aided by use of 5-ALA induced~     fluorescence guidance and use of an intraoperative ultra-low field MRI is higher compared to~     surgeries aided by 5-ALA induced fluorescene alone.~   "
135114|NCT01798745|"~     The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the~     drug) and pharmacodynamics (ie, how the drug affects the body) of JNJ-54452840 in~     participants with heart failure and anti-beta1-adrenergic receptor autoantibodies. The safety~     and tolerability of JNJ-54452840 will also be assessed.~   "
135115|NCT01798732|"~     The main objective of this study is to characterize the changes in IOP over 24 hours after~     selective trabeculoplasty SLT (before and 1 and 6 months after treatment, decreased IOP, type~     of rhythm, mesor, acrophase, amplitude). The secondary objective is to evaluate changes in~     ocular perfusion pressure (arterial pressure - IOP) and ocular blood flow in the optic nerve~     head after selective laser trabeculoplasty.~   "
135116|NCT01798719|"~     Non-alcoholic fatty liver disease (NAFLD) is a clinical/biochemical condition associated with~     the metabolic syndrome. As the disease stems from excess calorie intake and lack of physical~     activity, the correction of unhealthy lifestyles is the background of any prevention and~     treatment strategy~   "
135117|NCT01798706|"~     Primary objective:~      - To evaluate the effect of lixisenatide versus placebo over a period of 24 weeks on glycemic~     control, as evaluated by glycosylated hemoglobin (HbA1c) reduction, in older type 2 diabetes~     participants (T2DM) who are inadequately controlled with their current anti-diabetic~     treatment regimen.~      Main secondary objective:~      - To assess the safety and tolerability of lixisenatide compared to placebo in older T2DM~     participants (including occurrence of documented (Plasma Glucose PG < 60 mg/dL) symptomatic~     hypoglycemia and gastrointestinal side effects).~      Other secondary objectives:~        -  To assess the effect of lixisenatide compared to placebo after 24-week treatment on:~             -  Fasting plasma glucose (FPG);~             -  During liquid standardized breakfast meal challenge test : 2 hour- Postprandial~               Plasma Glucose (PPG) and Plasma Glucose Excursion;~             -  7-point Self-monitored plasma glucose (SMPG) profile;~             -  Body weight;~             -  Change in total daily dose of basal insulin (if taken);~             -  Percentage of participants requiring rescue therapy~             -  Safety and tolerability;~        -  To assess lixisenatide pharmacokinetic profile;~        -  To assess anti-lixisenatide antibody development.~   "
135118|NCT01798693|"~     Rotator Injury:~        -  Strength/range of Motion~        -  ASES, VAS~   "
135119|NCT01798680|"~     The purpose of this study is to determine the efficacy and safety of vitamin D3~     (cholecalciferol) supplementation on HIV progression and incidence of pulmonary tuberculosis~     among HIV-positive Tanzanian adult men and women initiating highly active antiretroviral~     therapy (HAART).~   "
135120|NCT01798667|"~     This study is designed to evaluate the efficacy and safety of DA-8031 and to decide the~     optimal dose of DA-8031 in male patients with premature ejaculation after oral administration~     on-demand.~      The investigators hypothesized that newly-developed DA-8031 would effect in delaying~     ejaculation in patients with premature ejaculation (PE).~      Design:~      Placebo-controlled, Randomized, Double-blind, Double-dummy, Parallel group, Fixed dose design~   "
135121|NCT01798654|"~     The purpose of this study to evaluate a safety of endoscopic ultrasound-guided fine needle~     aspiration (EUS-FNA) for patients with antithrombotic agents.~   "
135122|NCT01798641|"~     The goal of our study is to verify the effectiveness of the shunt and to identify the most~     sensitive criteria to select patients for surgery. The study is designed to assess~     improvement in walking and balance (gait), urinary function and memory after shunting. In~     addition, the study aims to identify the most accurate and sensitive tools to measure~     improvement for our patients.~   "
135123|NCT01798628|"~     The purpose of this study is to determine the effect of food on the pharmacokinetics (how the~     drug concentrations change over time) of abiraterone acetate 1000 mg when administered as a~     single dose in healthy male volunteers.~   "
135124|NCT01798602|"~     The CHAT Pilot Trial is designed to compare rosuvastatin against placebo in patients with~     suspected H1N1. The pilot study will assess the feasibility of our clinical protocols, and~     study procedures.~   "
135125|NCT01798589|"~     The purpose of this study is to compare the allergen ethylenediamine dihydrochloride when~     prepared using methylcellulose versus preparation using polyvinylpyrrolidone.~   "
135126|NCT01798576|"~     This prospective, national, multicenter, observational study will evaluate in routine~     clinical practice the efficacy and safety of re-treatment with Pegasys (peginterferon~     alfa-2a) plus ribavirin or regimens containing direct-acting antivirals in participants with~     chronic hepatitis C who failed previous treatment. Participants will be followed for the~     duration of their treatment (24, 48 or 72 weeks) and for 24 weeks of follow-up.~   "
135127|NCT01798563|"~     In this study the investigators are looking at two subtypes of Parkinson Disease (PD);~     tremor-dominant (TD) and postural imbalance and gait disorder (PIGD). This study will use~     magnet resonance imaging (MRI) to see how the brain reacts while resting and doing a~     finger-tapping task while on and off PD medication. This study will look at the differences~     between the two sub-types of PD and healthy volunteers.~      The investigators will test the hypothesis that connectivity at rest within the motor cortex~     and between the motor cortex and motor-associated regions such as the supplementary motor~     area and the pre motor cortex will not be as strong in PIGD compared to TD (increased~     activity and functional connectivity in TD group)~   "
135140|NCT01798394|"~     The primary goal of this project is to investigate the potential efficacy of exogenous~     progesterone (with supplemental relapse prevention counseling) on postpartum relapse in new~     mothers. Also to determine the feasibility of enhanced compliance monitoring and~     identification of collateral factors effecting outcomes.~   "
135128|NCT01798550|"~     The purpose of this study is to determine an effective enoxaparin dosing strategy in~     medically ill, morbidly obese patients. This study will include adult patients greater than~     18 yrs of age being admitted to Grady Hospital in Atlanta, GA. Potentially vulnerable~     patients such as prisoners, children, and pregnant women will not be enrolled in the study.~     Study participants will be contacted in person by the study personnel once inclusion criteria~     are met. Written informed consent will be obtained in person while hospitalized. Once the~     patient is consented they will be given enoxaparin and blood samples will be drawn. The data~     collected will be from the electronic medical record which is accessed only with a username~     and password so it is not publicly available. The data will be identifiable upon collection~     and will be kept on a password protected file on a computer in a locked office. The data will~     be de-identified after data analysis and only the study personnel will have access to the~     code that links identifiers to subjects. A HIPAA waiver will be requested to access existing~     data in order to identify patients for enrollment. All data will be collected in an office in~     the hospital. The study participants' burden will be minimal and dependent only on time of~     consent process since morbidly obese patients would be receiving this blood sample collection~     regardless of their participation in the study.~   "
135129|NCT01798537|"~     A simplified graded gut decontamination protocol combined with rigorous bi-weekly screening~     and appropriate bacterial prophylaxis, will lead to a 25% reduction in the acquisition of~     blood stream infections and to a 25% reduction in lower airway colonization with multi drug~     resistant organisms. There will be no concomitant rise in gram-positive or fungal infection~     or a surgency of new resistance patterns.~   "
135130|NCT01798524|"~     Kidney transplantation is the renal replacement therapy of choice for the majority of~     patients with end-stage kidney disease. Epidemiological studies of kidney allograft~     recipients can aid in the understanding of cause and effect of health and disease~     post-transplantation. The combination of health care and information technology has made the~     potential of transplant professionals to use health information effectively crucial to guide~     kidney transplant management. The aim of this study is to undertake an observational cohort~     study of kidney allograft recipients, supported by linking analysis across different database~     sources, to provide a comprehensive biomedical dataset of information.~   "
135131|NCT01798511|"~     Acute pancreatitis (AP) is one of the most common diseases in routine clinical practice of~     surgeons and gastroenterologists throughout the world. The high rate of pain relapse after~     oral refeeding contributes to high consumption of healthcare resources and prolonged hospital~     stay in AP patients. The data from the pilot MIMOSA trial suggest that early administration~     of nasogastric tube feeding may prevent pain relapse after oral refeeding in AP. The~     potential beneficial effects of enteral tube feeding include induction of postprandial~     gastrointestinal motility and improving the tolerance of oral refeeding. This may reduce the~     risk of pain relapse, thereby shortening length of hospital stay and reducing cost of~     treatment. The primary endpoint of the ORION trial will be the incidence of oral food~     intolerance. All eligible AP patients will be randomly allocated to either the Early~     Nasogastric Tube (ENT) group or Conventional Nutritional Management group (CNM) at 24h of~     hospital admission.~   "
135132|NCT01798498|"~     The aim of this clinical trial is to evaluate the efficacy and safety of Princess® VOLUME for~     the correction of nasolabial folds.~   "
135133|NCT01798485|"~     The purpose of this study is to determine whether combining ganetespib (STA-9090) with~     docetaxel is more effective than docetaxel alone in the treatment of patients with advanced~     non-small cell lung cancer.~   "
135134|NCT01798472|"~     The aim of this study is to compare the functional and radiological outcome after displaced,~     femoral neck fractures treated with either cemented or uncemented arthroplasties.~      The primary hypothesis is that the uncemented arthroplasty shows the same functional outcome~     at 12 month as the cemented arthroplasty.~   "
135135|NCT01798459|"~     The purpose of the study is to explore the effect of methylphenidate on state anxiety in~     children with attention deficit hyperactivity disorder.~      Patient population: 30 children diagnosed with attention deficit hyperactivity disorder. The~     subjects will be of all racial, ethnical and gender categories, ranging from 8 to 18 years of~     age.~      Structure: the study is a randomized double blind crossover study. The subjects will complete~     a continuous performance test, the cambridge neuropsychological test automated Battery,~     before and after given methylphenidate or placebo on the first day of the study. On the~     second day of the study, the subjects will receive either methylphenidate or placebo based on~     what was given on the first day of the study and they will complete the same task.~   "
135136|NCT01798446|"~     -  1. There is no standard treatment option for non-clear cell renal cell carcinoma (RCC).~        -  2. Patients with non-clear cell RCC is strongly assumed to have benefit from anti-VEGF~          treatment.~        -  3. There is no trial of axitinib for non-clear cell RCC.~        -  4. Axitinib is expected to show more potent efficacy over sorafenib or sunitinib in~          renal cell carcinoma.~   "
135137|NCT01798433|"~     In patients with unprotected left main (LM) true bifurcation lesion (cohort A), elective~     2-stent strategy is superior to provisional strategy at preventing the occurrence of 12-month~     target lesion failure after percutaneous coronary intervention for bifurcation lesion.~      In patients with unprotected LM non-true bifurcation lesion (cohort B), 1-stent technique~     with mandatory final kissing ballooning is superior to 1-stent technique without kissing~     ballooning at preventing the occurrence of 12-month target lesion failure after percutaneous~     coronary intervention for bifurcation lesion.~   "
135138|NCT01798420|"~     Corticosteroid treatment in diabetic patients admitted for COPD exacerbation are expected to~     significantly increase hemoglobin A1C levels~   "
135139|NCT01798407|"~     This research study will investigate the safety, tolerability, and benefit of bilateral deep~     brain stimulation (DBS) to the lateral habenula in subjects with treatment-resistant major~     depression (TRD) secondary to either nonpsychotic unipolar major depressive disorder (MDD),~     or bipolar disorder (BD) I. Six adult subjects with TRD will be treated in this single-site~     study at Baylor College of Medicine; subjects will be chronically symptomatic with~     significant functional disability, and will have demonstrated resistance to standard somatic~     and pharmacotherapeutic treatments. The primary outcome measure will be the change in the~     17-item Hamilton Depression Rating Scale (HDRS^17) six months after the commencement of~     stimulation.~   "
135143|NCT01798355|"~     The purpose of this study is to determine whether cognitive behaviour therapy is effective in~     the treatment of children and adolescents with dental anxiety. Our hypothesis is that~     children and adolescents who have been offered CBT shows significant better performance on~     outcome measures compared with patients in control group who have received treatment as~     usual.~   "
135144|NCT01798342|"~     Carbohydrates (CHO)-based drinks 2h before the induction of anesthesia are recommended to~     decrease insulin resistance. The addition of glutamine (GLN) in these beverages may enhance~     the benefits of CHO alone. However, only a few studies tested the safety of this formula. The~     objective of this study was to evaluate the gastric residual volume (GRV) after the intake of~     a beverage containing CHO plus GLN using magnetic resonance (MRI).~   "
135145|NCT01798329|"~     The aim of the study is:~        -  Epidemiological/observational: investigating the presence of neuropsychological and~          electrophysiological alterations, suggesting a condition of minimal hepatic~          encephalopathy(and its behavioral correlates), in childhood and young adulthood affected~          by pre-hepatic portal hypertension due to portal vein thrombosis, even for implementing~          specific diagnostic protocols.~        -  Interventional: collecting preliminary data on the effects of a probiotic, in order to~          implement a controlled clinical study.~   "
135146|NCT01798316|"~     The purpose of this study is to evaluate the use of IV acetaminophen for postoperative pain~     management after laparoscopic cholecystectomy to determine if its use to supplement standard~     of care pain management decreases the incidence of post-operative nausea and vomiting.~   "
135147|NCT01798303|"~     The main purpose of this study is to evaluate a once daily (QD) 40-milligram (mg) oral dose~     of LY2940094 in participants with an alcohol dependency to evaluate if LY2940094 will reduce~     alcohol drinking in these participants. The study will last for 8 weeks.~   "
135148|NCT01798290|"~     Objective: The aim of this study is to assess the impact of an educational program of~     Narrative Medicine workshop reading diaries dedicated to medical students on their empathy.~      Design: Randomized Controlled Trial in 2 arms. Participants: Medical students (4th years) of~     the University Paris Descartes. Methods: participants will be randomized in 2 groups. The~     allocation of participants will be done by a computerized randomization list, the sequence~     will be created by an independent statistician. Participants will be blinded of the study~     hypothesis. Allocation concealment will be provided because only the statistician will have~     access to the randomization list.~      A program of Narrative Medicine with lesson in small group of workshop reading patients'~     diaries  vs workshop reading literature.~      Outcome: The primary endpoint will be a first measure of the empathy of the medical students.~     The secondary endpoints will be a second measure of the empathy of the medical student;~     satisfaction of the student relative to the educational program .~      Potential interests: We believe that the workshop reading patients' diaries can develop the~     thinking of the student with respect to his behavior with the patient, and so the relation~     between student and patient.~      Sample size expected: 200 participants.~   "
135149|NCT01798277|"~     This study aims to compare antiarrhythmic drug therapy with catheter ablation using the~     SmartTOUCH catheter (Biosense Webster Inc.) as treatment for patients with ventricular~     tachycardia and coronary artery disease~   "
135150|NCT01798264|"~     evaluate the safety and tolerability of ITCA 650 in subjects with type 2 diabetes mellitus.~   "
135151|NCT01798251|"~     To confirm the efficacy and safety of XELOX with capecitabine maintenance in treatment of~     elderly advanced gastric cancer (AGC) by comparing it with that of XELOX regimen.~   "
135152|NCT01798238|"~     The study design of this trial is double blind, parallel-group, randomized, placebo~     controlled study~   "
135153|NCT01798225|"~     Our overall hypothesis is that treatment of periodontal disease will produce better diabetes~     glycemic control (glycated hemoglobin A1c, or HbA1c) and reduced levels of the catalytically~     active form of matrix metalloproteinase (aMMP-8) in the Gullah African American type 2~     diabetes patients living on the Sea Islands of the South Carolina coast. The gingival~     crevicular fluid (GCF) aMMP-8 levels will be measured through a site-specific, novel~     noninvasive technique allowing the pathophysiological status of the periodontium tissue to be~     monitored. The investigators will conduct an interventional study on this population with~     minimal genetic admixture.~   "
135154|NCT01798212|"~     A prospective multi center case controlled trial on the clinical feasibility of a new full~     thickness endoscopic plication device for patients with GERD.~      The primary objective of the present trial is to investigate, clinical feasibility of the~     GERDx™ device, evaluating surgical aspects, quality of life, and symptom sores. Secondary~     objective of the trail is to evaluate objective data before and after the procedure, using~     manometry and 24h impedeance measurement~   "
135155|NCT01798199|"~     Virtual environments and information communication technologies (ICT) offer large~     perspectives in the field of assistive care and rehabilitation.~      As potentially endless, the scenarios and environment used using 3D can provide immersive~     social and interactive context for enjoyable and therapeutic exercises in the aging~     population. In addition it is also possible to use this type of serious game and scenario in~     very easy to use devices such as lap top or tablet.~      Social exclusion has many causes, Apathy as one of the most common behavioural disturbances~     found in old adults populations alters significantly social and emotional interaction.~      Even though, progress in VR has been made over the past year, the presence of such technology~     in daily living space is still at the embryonic stage.~      The European e-Inclusion policy stresses the importance of ICT in improving the quality of~     life in potentially disadvantaged groups, including older people and persons.~      The VERVE project is developing ICT tools to support the treatment of people who are at risk~     of social exclusion due to apathy associated with a disability.~      As people aged and autonomy worsen fear for safety and comfortable means to maintain social~     and Health Related Quality of Life (HRQL) status are public health issues.~      Moreover, even though older adults would like to perform some activities such as walking in~     the streets some are reluctant to go out of their homes as the external environment is~     perceived as potentially unsafe.~      Apathy, the most common behavioural symptoms in aging population is characterized by symptoms~     of reduced initiation and responsiveness to environmental interactions. The syndrome of~     Apathy takes form of diminished goal-directed behaviour, characterised by emotional blunting,~     loss of initiative and loss of interest. Apathy along with the nosological characteristics of~     dementia induces impairment in autonomy level and therefore dependence as cognitive~     impairments worsened.~      The importance of stimulation could be related to the concept of engagement defined as the~     act of being occupied or involved with an external stimulus. Engaging older person with or~     without Alzheimer's disease and related disorders in appropriate activities has been shown to~     yield beneficial HRQL effects such increasing positive emotion, improving cognition,~     functional autonomy and quality of life.~      Accordingly, enriched environments with high definition virtual representation of cities and~     activities of interest have the potentials not only to encourage patients to get active in a~     safe and interactive environment but also to create access to enjoyable and stimulating~     settings for the more severe patients.~      The VR setting from VERVE proposed personalised and populated environments available on two~     different, but interlinked hardware platforms: 1/: standard gaming set-up in the home,~     nursing home or day hospital therapy group; and 2/ mobile tracked internet devices~     (e.g.,IPad). The system will ensure maximum openness and dissemination by using 3D Web~     technologies.~   "
135156|NCT01798186|"~     This primary aim of this study is to assess the effects of passive (second-hand) inhalation~     of cannabis smoke on toxicological analysis of native oral fluid (saliva), urine and blood~     specimens. The results of this study will help inform the validity of oral fluid as a~     biomarker of cannabis exposure and to determine whether, and for how long, passive inhalation~     of cannabis smoke could result in a positive toxicology result.~   "
135157|NCT01798173|"~     Available data do not allow carcinogenesis mechanisms in cirrhotic patients to be well~     understood in absence of studies taking into account all recognised factors. A large scale~     clinical, biochemical and molecular studies is potentially relevant to the understanding of~     nutrition, physical activity, body weight metabolic syndrome whatever the etiology of~     underlying cirrhosis. It will open new perspectives :~        -  in prevention of hepatocellular carcinoma development in cirrhotic patients through~          dietary counselling and therapeutics of metabolic syndrome,~        -  in early screening of hepatocellular carcinoma in cirrhotic patients through~          spectroscopic technology and later proteomic study resulting in an improvement of~          hepatocellular carcinoma prognosis.~   "
135158|NCT01798160|"~     Selective Internal Radiation Therapy is superior to Transarterial Chemoembolisation for the~     treatment of intermediate stage hepatocellular carcinoma.~   "
135159|NCT01798147|"~     Selective Internal Radiotherapy is superior to Transarterial Chemoembolisation for the~     treatment of intrahepatic cholangiocellular carcinoma (CCC).~   "
135160|NCT01798134|"~     This is a non-randomized, prospective, pilot, Multicenter Study of Drug-eluting bead~     transarterial chemoembolization (DEB-TACE) using Doxorubicin-Loaded Embozene® Tandem™~     Microspheres to treat hepatocellular carcinoma (HCC).~   "
135162|NCT01798108|"~     A new bone-seeking radiopharmaceutical drug, called Radium-223 dichloride (formerly known as~     Alpharadin), is currently under development. It is an injectable aqueous solution~     containing radium-223, a radionuclide that emits radiation of another quality and with a~     different distribution than radiopharmaceuticals currently in use.~      After injection of the drug into the blood, a large portion of the drug will accumulate in~     the bones, and irradiate the skeletal metastases. The drug is expected to be retained longer~     in the painful sites of bone than in other sites of the body, and may alleviate pain through~     its radiation. Radium-223 is expected to be both efficacious as regards the targeted~     localised irradiation, and also to have a favourable safety profile.~      The radiopharmaceutical drug Radium-223 has not been given to humans before. In this first~     clinical study in man, a so-called phase I study, the safety, tolerance and the toxicity of~     various radioactivity doses of Radium-223 will be evaluated.~   "
135163|NCT01798095|"~     Determine if investigational products and reference standard produce similar responses.~   "
135164|NCT01798082|"~     Pelvic organ prolapse is a common condition that affects millions of women every year. There~     are many options for treatment and it can be difficult to make a decision as how best to~     proceed. Previous studies have shown that decisional aids (DAs) may improve knowledge,~     physician-patient communication, decisional conflict, and patient satisfaction. However, no~     study has evaluated the role of a decisional aid among women presenting for evaluation and~     management of prolapse. We would like to determine if a decision aid for prolapse decreases~     the amount of decisional conflict women face when choosing a plan of care.~      We hypothesize that there will be a difference in the level/amount of decisional conflict~     between women who receive a DA and those who do not. Specifically, we anticipate that women~     randomized to receiving standard counseling and a DA with have less decisional conflict than~     the cohort receiving standard counseling alone.~   "
135165|NCT01798069|"~     Objective: The aim of this study is to assess the impact of an educational program of~     Narrative Medicine workshop reflexive writing dedicated to medical students on the~     satisfaction of standardized patients.~      Design: Randomized Controlled Trial in 2 arms. Participants: Medical students (4th years) of~     the University Paris Descartes. Methods: Participants will be randomized in two groups. The~     allocation of participants will be done by a computerized randomization list, the sequence~     will be created by an independent statistician. Participants will be blinded of the study~     hypothesis. Allocation concealment will be provided because only the statistician will have~     access to the randomization list.~      A program of Narrative Medicine in Class-led instruction workshop reflexive writing vs~     workshop reading medical publication.~      Outcome: The primary endpoint will be the satisfaction of standardized patient relative to~     the empathy of the medical students. The secondary endpoints will be the empathy of the~     medical students; recommendation of the student by the standardized patients to friends or~     relatives; students' satisfaction.~      Potential interests: The investigators believe that the workshop reflexive writing can~     develop the thinking of the student with respect to his behavior with the patient, and so the~     relation between student and patient.~   "
135166|NCT01798056|"~     The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals'~     HZ/su vaccine in adults with solid tumours undergoing chemotherapy.~   "
135167|NCT01798043|"~     The study aims to use cardiac MRI scans and analysis techniques to evaluate differences in~     cardiac function after 12 months of pacing in patients with pacing leads placed in different~     positions within the right ventricle (apically or septally).~   "
135168|NCT01798030|"~     Vitamin D deficiency is associated with a heightened risk for developing type 2 diabetes,~     hypertension, and osteopenia/osteoporosis. Vitamin D is made in the skin when it is exposed~     to sunlight and it is also obtained from the diet and dietary supplements. Older people,~     individuals with high skin pigmentation, obese and sedentary individuals have low levels of~     Vitamin D because pigmentation blocks Vitamin D production in the skin, aging and physical~     inactivity are associated with reduced exposure to sunlight, and obesity is associated with~     the storage of Vitamin D in fat preventing its utilization by muscle, bone and other tissues~     that require its metabolic action. These conditions are also associated with heightened risk~     for developing type 2 diabetes, glucose intolerance, hypertension, and~     osteopenia/osteoporosis in older and obese individuals. This is particularly heightened in~     older women who tend to have increased body fat, are more physically inactive and are at high~     risk for central obesity and its metabolic consequences of diabetes, hypertension and~     osteoporosis.~   "
135169|NCT01798017|"~     This open-label study is being conducted to determine whether a mifepristone-misoprostol~     regimen for uterine evacuation which consists of 200 mg mifepristone followed 24 hours later~     by 800 mcg buccal misoprostol is acceptable to women and providers and feasible for~     introduction in public sector facilities in Bangladesh. It will also determine the~     feasibility of women availing the option of taking their dose of misoprostol outside the~     facility.~   "
135170|NCT01798004|"~     This pilot clinical trial studies busulfan, melphalan, and stem cell transplant after~     chemotherapy in treating patients with newly diagnosed neuroblastoma that is likely to come~     back or spread. Giving chemotherapy to the entire body before a stem cell transplant stops~     the growth of tumor cells by stopping them from dividing or killing them. After treatment,~     stem cells are collected from the patient's blood and stored. More chemotherapy or radiation~     therapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are~     then returned to the patient to replace the blood-forming cells that were destroyed by the~     chemotherapy.~   "
135171|NCT01797991|"~     This is a prospective, randomized, unicentric, two-arm, parallel, controlled, and double~     blind pilot study.~      The purpose of this pilot study is to assess the feasibility of a trial designed to compare~     the quality of life of patients taking dexamethasone in two different ways to prevent~     hypersensitivity reactions to paclitaxel.~      Dexamethasone given intravenously (IV) 30 minutes before paclitaxel could improve quality of~     life, could adequately prevent hypersensitivity reactions to paclitaxel and could reduce~     adverse effects compared to dexamethasone given orally 12 hours and 6 hours before~     paclitaxel.~   "
135172|NCT01797978|"~     This study is to see whether the intravenous administration of methylene blue improves the~     outcome in severe sepsis and septic shock.~   "
135173|NCT01797965|"~     The primary objective of the study is to assess the safety and tolerability of long-term~     treatment with BIIB019 (Daclizumab High Yield Process; DAC HYP) monotherapy in participants~     with relapsing remitting multiple sclerosis (RRMS) who completed Study 205MS301~     (NCT01064401), Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318).~      Secondary objectives of this study in this study population are as follows:~      To describe MS-related outcomes, including MS relapse, disability progression, MS lesion~     formation, and participant-reported impact of MS, following long-term treatment with DAC HYP~     To assess the long-term immunogenicity of DAC HYP administered by prefilled syringe (PFS) To~     assess the safety, tolerability, and efficacy of switching to DAC HYP in participants~     previously on long-term treatment with interferon β-1a (Avonex) in Study~     205MS301(NCT01064401).~   "
135174|NCT01797952|"~     The study will be conducted at departments of Medical Oncology and Hematology, All India~     Institute of Medical Sciences (AIIMS).~      Patients with various malignancies who are taken up for high dose chemotherapy followed by~     stem cells transplant (blood and marrow transplant) have very high chances of developing~     severe oral mucositis (generally 60-80% in different studies and our own previous~     experiences). This not only causes significant morbidity but also hampers quality of life~     needing use of parenteral nutrition, analgesics, and antibiotics.~      No definite treatment exists for prevention or treatment of oral mucositis in this group of~     patients. Though one study has suggested that use of IV palifermin (a keratinocyte growth~     factor) will reduce duration and severity. Palifermin is very expensive and not available in~     country. Recently investigators have shown effectiveness of a probiotic Lactobacillus CD 2 in~     reducing incidence and severity of chemo-radiotherapy induced mucositis in head and neck~     squamous cell cancer patients. (Published online in European Journal of Cancer:~     http://dx.doi.org/10.1016/j.ejca.2011.06.010)European Journal of Cancer 2012;4:875-881.No~     significant toxicity has been reported with its use.~      A pilot study on similar aspect was completed recently at our center(Clinical trial.gov~     identifier:NCT 01480011) and in 31 patients who received this only 6 (20%) developed grade~     III or IV Mucositis. Now, investigators want to study the efficacy of this drug to reduce~     severity of mucositis in patients undergoing myeloablative hematopoietic stem cell~     transplantation. The study drug and placebo will be supplied by CD Pharma India Private~     Limited.~      Investigators further give undertaking that study will be carried as per GCP and declaration~     of Helsinki.~   "
135175|NCT01797939|"~     Proton pump inhibitor (PPI) is widely used in patients with gastroesophageal reflux disease~     (GERD), however, some patients fail to respond to PPI therapy. Recent reporters suggest that~     depressive disorders, anxiety, sleep dysfunction were related with the symptomatic responses~     to a PPI treatments. Nevertheless, the predictive factors of response to PPI treatment still~     remain controversial. Therefore, the aims of this study were to investigate the efficacy of~     PPI therapy, and to evaluate the predictors of the PPI response in patients with symptomatic~     GERD by using the questionnaire which consisted of GERD symptoms, GERD impact scale (GIS),~     Epworth sleepiness scale (ESS), Pittsburgh sleep quality index (PSQI), Hospital anxiety and~     depression scale (HADS), and WHO quality of life scale abbreviated version (WHOQOL-BREF).~   "
135176|NCT01797926|"~     This is a three-period, three sequence, reference replicated, cross-over study to determine~     the bioequivalence of two amlodipine and losartan FDC tablet formulations FDC5/50 and~     FDC5/100 (GSK2944406; 5 mg amlodipine and 50 mg and 100 mg losartan) to reference amlodipine~     and losartan tablets co-administered in two groups enrolling 102 healthy adult male and~     female subjects under fasting conditions.~      A description of each treatment is provided below:~      A (Reference) = 1 x 5 mg amlodipine tablet and 1 x 50 mg losartan tablet. B (FDC5/50) = 1 x 5~     mg amlodipine and 50 mg losartan tablet C (Reference) = 1 x 5 mg amlodipine tablet and 1 x~     100 mg losartan tablet D (FDC5/100) = 1 x 5 mg amlodipine and100 mg losartan tablet The~     treatments will be administered in accordance with the randomisation schedule as.~      Group 1: A → A → B or A → B → A or B → A → A Group 2: C → C → D or C → D → C or D → C → C All~     subjects will attend a screening visit within 28 days of their first dosing period (Day 1).~     The baseline assessments will be conducted the day before the first dosing.~      In each treatment period, subjects will be admitted to the clinic in the evening before Day~     1. All subjects will receive a single oral dose of amlodipine and losartan in the morning on~     Day 1. All the subjects will remain in the clinical unit until completion of all assessments~     at 24 hours post-dose on Day 2 including collection of the 24 hour post-dose PK sample.~     Subjects will return to the clinic for pharmacokinetic samples at 36, 48, 72 and 96 hours~     post-dose.~      The three treatment periods will be separated by a washout period of 10-17 days. Upon~     completion of the last dosing period, or early withdrawal, subjects will return to the~     clinical unit within 14-21 days for a follow up visit.~   "
135177|NCT01797913|"~     assess the efficacy and safety of gemcitabine in the maintenance treatment of advanced~     non-small cell lung cancer~   "
135178|NCT01797900|"~     The purpose of this study is to determine whether Intensity-modulated radiation therapy~     (IMRT) combined inductive and concurrent chemotherapy with more intensive regimen (cisplatin~     and paclitaxel) is feasible and effective than current standard treatment for high-risk~     locally advanced NPC patients.~   "
135179|NCT01797887|"~     Aim of this study is to evaluate the effectiveness of Ayurvedic diet and lifestyle counseling~     compared to conventional standard diet and lifestyle counseling in outpatient mothers with~     burnout-syndrome.~   "
135180|NCT01797874|"~     To evaluate the efficacy of pazopanib maintenance after 1st line CTx for SCLC.~   "
135192|NCT01797718|"~     Boys with constitutional delay of growth and puberty (CDGP) should be offered evidence-based~     effective and safe treatment option. This study compares the effects of low-dose testosterone~     and aromatase inhibitor letrozole on pubertal progression. The hypothesis is that, in boys~     CDGP showing earliest signs of puberty, peroral letrozole (2.5 mg/d for 6 mo) induces faster~     biochemical and clinical progression of puberty as compared to low-dose intramuscular~     testosterone Rx (~1mg/kg/mo for 6 mo). In addition, 10 or more boys who select watchful~     waiting instead of medication will provide background data on the natural progression of~     CDGP, and their data will not be used in primary statistical comparisons.~   "
135193|NCT01797705|"~     The purpose of this protocol is to improve the current FDA-approved continuous positive~     pressure auto-titration algorithm, including treatment precision, residual disease detection~     characteristics and phenotyping with the DeVilbiss brand AutoAdjust CPAP device.~   "
135181|NCT01797861|"~     Chronic central serous chorioretinopathy (CSC) is a relatively frequent eye disease that~     often occurs in patients in the professionally active age range. In this disease, there is~     pooling of fluid under the central retina (the macula). This specific form of macular~     degeneration can cause permanent vision loss, image distortion, loss of color and contrast~     vision due to this fluid under the retina. An early diagnosis and treatment may improve the~     visual outcome and quality of life. To date there is no international consensus on the~     optimal treatment of chronic CSC. Many retrospective studies suggest that treatment with~     photodynamic therapy (PDT) is effective in chronic CSC. Micropulse laser (ML) therapy may~     also be effective in this disease.~      The proposed study is the first prospective randomized controlled trial in chronic CSC. In~     this study, participants with chronic CSC will be randomized into two treatment groups, PDT~     or ML treatment. The trial is a superiority study, because retrospective studies suggest that~     PDT treatment may be more effective than ML treatment. Therefore, PDT treatment is challenged~     against ML treatment.~      The null hypothesis of the study is that PDT treatment is more effective than ML treatment in~     patients with active chronic CSC. The alternative hypothesis is that PDT treatment is not~     more effective than ML treatment in these patients.~      Treatment success will not only be based on anatomical improvement, but also on functional~     endpoints, which are most important from a patient's perspective.~      The study will take place in five large tertiary referral university hospitals in Europe that~     have extensive experience with conducting clinical trials (in Nijmegen, the Netherlands;~     Cologne, Germany; Leiden, the Netherlands; Oxford, United Kingdom; and Paris, France). Each~     of these centers has confirmed sufficient funding to conduct the research. The study will~     last max. 8 months per participant. Each participant will come for 5 (in the case of 1~     treatment) or 7 visits (in the case of 2 treatments). Study evaluations will be mostly part~     of regular clinical care. The whole study will last for max. 24 months.~   "
135182|NCT01797848|"~     The purpose of this study is to determine whether 24 week treatment with the Daclatasvir~     (DCV) in combination with Pegylated-interferon alfa 2a (pegIFNα-2a) and Ribavirin (RBV) is~     safe and demonstrates rate of Sustained Virologic Response at follow up week 24 (SVR24)~     (defined as undetectable HCV RNA at post-treatment Week 24) that are non-inferior to 48 weeks~     of the dual combination therapy of pegIFNα-2a/RBV in a majority of study subjects~   "
135183|NCT01797835|"~     Screening youth in the primary care setting is one way to identify adolescents who may be~     at-risk for future alcohol problems. The current study tests the new NIAAA screening guide~     questions, which ask about friend and adolescent drinking, to see how well these questions~     work to predict subsequent alcohol use, problems, and involvement in other risk behaviors,~     such as sexual risk-taking and delinquency. In addition, the investigators plan to provide a~     brief motivational intervention for some at-risk teens and see whether alcohol use differs~     for those teens who receive the intervention and those teens who receive enhanced usual care.~     The results of this study have the potential to significantly impact the standard of care for~     identifying and intervening with at- risk youth in primary care settings.~   "
135184|NCT01797822|"~     The purpose of this study is to evaluate whether, in people with dry eye syndrome, over the~     counter artificial tears and the prescription eye drop, dexamethasone, change or effect the~     eyes response to a low humidity environment.~      It is known that irritation from dry eye can be improved by over the counter artificial tears~     because they wet and lubricate the eyes. The prescription eye drop, dexamethasone, can also~     improve eye irritation by decreasing the inflammation that develops in dry eye. Thus, the~     investigators hypothesize that the use of these conventional dry eye treatments will improve~     the eyes' response to a low humidity environment.~   "
135185|NCT01797809|"~     The objective of this PMS is to gain information about safety and efficacy in real practice~     as a regulatory commitment required by KFDA(Korea Food and drug administration)~   "
135186|NCT01797796|"~     The purpose of this study is to examine the effect of PF-06305591 on capsaicin and~     capsaicin/heat-induced neurogenic flare.~   "
135187|NCT01797783|"~     The purpose of this study was to demonstrate substantial equivalence of the new DAILIES®~     AquaComfort Plus® Multifocal (DACP MF) contact lens to the commercially available Focus®~     DAILIES® Progressives (FDP) contact lens.~   "
135188|NCT01797770|"~     This is a Randomized trial on Mechanical Bowel Preparation in Laparoscopic Colorectal~     Surgery. In this trial patients with left sided colon and rectal tumors were randomized to~     receive mechanical bowel preparation or no preparation to assess postoperative complications~     and outcome~   "
135189|NCT01797757|"~     A potential application for unstructured monoacylglycerol (MAG) containing long chain~     polyunsaturated fatty acids (LC-PUFA)can be to provide essential fatty acids to humans who~     chronically consume lipases inhibitor such as Orlistat® for weigh lowering reasons. Indeed,~     it is predictable that chronic consumption of Orlistat® led to a depletion of essential fatty~     acids with time, therefore unstructured MAG containing LC-PUFA can be an option as a source~     of LC-PUFA for patients under Orlistat® treatment and hypothetically for subjects with other~     type of maldigestion/malabsorption. Potential applications of such concept are therefore~     related to disease conditions comprising low lipid digestion due to lipase activity~     insufficiency.~      In the present study, in order to see the response information for eicosapentanoic acid (EPA)~     delivery, EPA will be provided either as a mixture of free monoacylglycerols or as~     triacylglycerol (TAG). The erythrocyte and plasma fatty acid composition from subjects under~     Orlistat® consumption will be analyzed.~   "
135190|NCT01797744|"~     Recently, the investigators has shown that dizziness is common among patients with first time~     stroke and that it affects self perceived health. There are indications that vestibular~     rehabilitation can have effect of neurological causes of dizziness and vertigo and it~     therefore seems important to find out if vestibular rehabilitation can affect dizziness among~     patients with stroke.~      The aim of this study is to find out if vestibular rehabilitation can have any effect on~     function, balance and self-rated health among patients with first time stroke.~   "
135191|NCT01797731|"~     This is a randomized, controlled, blinded prospective study comparing the use of the usual~     cutting guides with a palm-sized digital surgical navigation system in unilateral total knee~     arthroplasty. Analysis of pre- and post-operative X-rays will be used to compare alignment of~     the tibial (shinbone) implant components. The investigators expect that the FDA-approved~     hand-held surgical navigation device will increase the accuracy and precision of the tibial~     cut by telling the surgeon the exact position of the cutting block before the surgeon makes~     the cut, allowing minor adjustments to be made. The investigators expect the conventional~     device to take less time to use, but that this difference will decrease as the surgeon~     becomes more familiar with the device. The investigators expect the intraoperative~     measurements acquired by the KneeAlign system to strongly correlate with the radiographic~     alignments measured postoperatively.~   "
135194|NCT01797692|"~     This is a multicenter pilot study, proposed for cases and controls 3 departments in France.~      Cases are cured patients who have had prostate cancer for at least 10 years. Cookies are~     healthy subjects selected by lottery on voter list.~      Volunteer subjects (cases and controls) are offered a consultation and assessment with an~     geriatrician.~   "
135195|NCT01797679|"~     This study is the radiological component of an earlier registered RCT under the title:~     Efficacy of Exercise on Physical Function and Cartilage Health in Patients With Knee~     Osteoarthritis. The main purpose in this component of the study is to evaluate the efficacy~     of aerobic exercise and strength training on the T2 and T1 rho relaxation times of the~     articular cartilage. It has been proven that exercise can improve function and reduce the~     need for analgesics in patients with osteoarthritis. With this study, we wish to investigate~     if different kinds of exercise can cause measurable improvements in T2 and T1 rho relaxation~     times of the articular cartilage, and also if this improvements are transient or permanent.~   "
135196|NCT01797666|"~     Objective:~      subjects to compare the single dose bioavailability of Torrent's Pioglitazone Hydrochloride~     Tablets 1 × 45 mg and Actos® Tablets 1 × 45 mg of Takeda Pharmaceuticals America, Inc. Dosing~     periods of studies were separated by a washout period of 12 days and 11 days respectively.~      Study Design:~      Randomized, Two-Way Crossover, Single-Dose, and Open-Label~   "
135197|NCT01797653|"~     Randomized controlled trial (therapeutic vs. placebo CPAP) including 46 patients with~     obstructive sleep apnea (OSA) to define the physiological effects of continuous positive~     airway pressure (CPAP) therapy withdrawal on myocardial perfusion and dermal and renal~     microvascular function during a 2 week period.~   "
135198|NCT01797640|"~     Currently, the treatment of choice for tibial fracture is intramedullary nailing. This~     procedure has been shown to have low rates of infection, high rates of bone healing, and a~     faster return to weight bearing and activity in comparison to conservative treatment. In~     concurrent fractures of the posterior or medial malleolus and the tibia, it is now common to~     identify, reduce, and fix the malleolar fracture prior to intramedullary nailing of the~     tibia. In this retrospective study, our aim is to establish that reducing malleolar fractures~     prior to tibial nailing is a safe treatment in which the reduction of the malleolus is~     maintained intraoperatively, postoperatively, and remains reduced until the fracture has~     healed.~   "
135199|NCT01797627|"~     This multicenter, prospective study of children with hydrocephalus will examine whether or~     not ventricle size is associated with poor cognitive outcomes. It is expected that results~     will indicate larger ventricular size at 6 months after surgery for the initial treatment of~     hydrocephalus will relate to poorer cognitive outcomes. This study is being conducted by the~     Hydrocephalus Clinical Research Network (HCRN), a network established to conduct~     multi-institutional clinical trials on pediatric hydrocephalus.~   "
135200|NCT01797614|"~     Increased intra-abdominal pressure (IAP) affects pulmonary dynamics. However, little is~     studied whether pulmonary dynamics affects IAP. We hypothesize that the change of IAP can~     also reflect the change of pulmonary dynamics. In this study, we choose patients who received~     spontaneous breathing trial to answer the hypothesis.~   "
135201|NCT01797601|"~     The purpose of the study is to investigate whether insulin sensitivity and insulin resistance~     of the human brain is comparable in all insulin sensitive parts of the brain and whether~     correlates to other phenotypic information (i.e. whole body insulin sensitivity, BMI, age) of~     the study participants.~   "
135202|NCT01797588|"~     Effective pain management following total knee arthroplasty is important to facilitate early~     mobilization and rehabilitation. To manage post-operative pain, multimodal analgesia,~     including acetaminophen, NSAID's, gabapentin, opioids and local anesthetics are used.~     However, local anesthetics injected into the femoral nerve area may cause a block in motor~     function of the quadriceps muscle. Both adductor-canal peripheral nerve block performed~     pre-operatively, and periarticular infiltration performed intra-operatively are effective in~     reducing pain following TKA without causing quadriceps motor block which can impede~     mobilization. No published trials have been found that compare single shot adductor-canal~     block plus periarticular infiltration to periarticular infiltration only or adductor-canal~     nerve block only. The purpose of this trial is to examine the effect of 3 different~     approaches to nerve blockade: 1) adductor-canal block plus periarticular infiltration; 2)~     adductor-canal block only; 3) periarticular infiltration only, on pain, analgesic~     consumption, mobility, pain related interference with activities and length of hospital stay~     in participants undergoing unilateral TKA. Patients will be eligible for participation if~     they are 18 years old or older, and can speak, and read English. Ninety-six trial~     participants will be randomized to receive 1 of the 3 approaches to nerve blockade as part of~     their pain management plan. Outcomes will be measured on post-operative days 1 and 2 and~     length of stay will be calculated in hours after the participant is discharged to home. It is~     hypothesized that participants that receive both adductor-canal nerve block plus~     periarticular infiltration will report less pain, improved mobility and less pain related~     interference with activities.~   "
135203|NCT01797575|"~     We propose to conduct a double-blind placebo-controlled trial with a widely available and~     prototypical non-steroidal anti-inflammatory agent, aspirin, and an antioxidant agent, NAC,~     involving symptomatic Bipolar Disorder type I and II patients having a depressive or mixed~     episode currently. This will be the first controlled study to test the hypothesis that~     aspirin and NAC, by themselves or in combination, will be beneficial in treating depression~     in bipolar disorder patients and in promoting mood stabilization.~      Our study has the following Aims:~      Aim I - Examine efficacy of aspirin in treating depression in bipolar patients in a~     double-blind placebo-controlled add-on design; Aim II - Examine efficacy of NAC in treating~     depression in bipolar patients in a double-blind placebo-controlled add-on design; Aim III -~     Examine efficacy of combined treatment with aspirin and NAC looking for synergistic,~     potentiating effects; Aim IV - Examine the role of markers of neuroinflammation, as possible~     mediators or modulators in therapeutic response in the treatment of depression in patients~     with Bipolar Disorder.~   "
135204|NCT01797562|"~     To evaluate the performance and safety of seven T.R.U.E. Test Panel allergens in subjects~     6-17 years of age with suspected contact dermatitis.~   "
135205|NCT01797549|"~     The goal of this project is to develop a test to assess frontal lobe function using a rapid,~     inexpensive, objective, and standardized method, without the need for expertise in cognitive~     test administration. Such methods would be particularly helpful in traumatic brain injury~     (TBI), where objective measures are needed, and would greatly expand the capacity to make~     such assessments in clinical practice and research.~   "
135206|NCT01797536|"~     The purpose of this study is to evaluate the pharmacokinetics (PK) profile of elbasvir~     (MK-8742) after a single dose to participants with mild, moderate, or severe hepatic~     insufficiency compared with healthy controls.~   "
135207|NCT01797523|"~     The goal of this clinical research study is to learn if the combination of everolimus,~     letrozole, and metformin can help to control recurrent or progressive endometrial cancer. The~     safety of this drug combination will also be studied.~      Everolimus is designed to block a protein inside cancer cells that is involved in cancer~     growth.~      Letrozole is designed to block a protein from making estrogen. This may interfere with the~     growth of cancer cells.~      Metformin is commonly used to control blood sugar levels in patients with diabetes. It is~     designed to lower insulin levels, which may slow or stop the growth of endometrial cancer~     cells.~   "
135208|NCT01797510|"~     This study is designed to compare an intensive lifestyle and activity coaching program~     (&quot;Sessions&quot;) to usual care for diabetic patients who are sedentary. The question to~     be answered is whether the Sessions program improves clinical or patient centric outcomes.~      Recruitment is through invitiation only.~   "
135209|NCT01797497|"~     The overall goal of this three-year study is to adapt and test a brief, feasible intervention~     using a communication tool and brief parent coaching to increase the capability of parents of~     children and youth with special health care needs to exchange and use medical information in~     partnership with their child's physicians when their children require sub-specialty referral.~     We hypothesize that the use of tools to coordinate referrals between physicians and parents~     will facilitate increased communication between primary care physicians(PCPs) and~     specialists, and that parents trained in information exchange and care planning will~     experience increased self-efficacy in interacting with their child's physicians.~      There are two primary aims of the study. The first aim is to adapt a joint parent-provider~     referral communication and care planning intervention (i.e., the 'referral care plan') for~     use with ethnically diverse populations in an electronic communication environment, and~     optimize its usability in the practice setting. The second aim is to test the referral care~     plan in nine pediatric primary care and subspecialty practices in two states, using a stepped~     wedge cluster randomized trial, to evaluate its effect on communication, parent~     self-efficacy, and patient outcomes.~   "
135210|NCT01797484|"~     The aim of the RIMINI-Trial is to examine the effect of Ranolazine on ischemic myocardium in~     acute myocardial ischemia.~      A pilot-trial by Venkatamaran et al. recently demonstrated, that the area of ischemic~     myocardium in patients with stable coronary artery disease can be reduced by~     Ranolazine-treatment2. This effect was shown by significantly reduced areas of atypical or~     dysfunctional myocardium in SPECT-examinations.~      The dimension of myocardial damage (i.e. area of ischemic myocardium) is directly related to~     the rate of complications (i.e. left-ventricular pump failure, malignant arrhythmia) and the~     grade of Rehabilitation to daily life (i.e. persistent reduced left-ventricular ejection~     fraction).~      In patients with stable angina pectoris, Ranolazine is used with beneficial results1.~     Ranolazine improves diastolic blood flow and therefore microcirculation in the myocardium by~     reducing diastolic tension (via inhibiting late Na+-Influx and consecutive Ca2+-Overload).~      Recently published data2 showed that treatment with Ranolazine significantly reduces the~     ischemic area in chronic damaged myocardium. This is due the effect of improved~     microcirculation in hibernating myocardium.~      Early administration of Ranolazine and improvement of microcirculation in patients with acute~     damaged myocardium (i.e. directly after acute ischemia) should lead to a recruitment and~     re-uptake of cardiac activity of hibernating myocardium.~      For the RIMINI-Trial patients are given Ranolazine on top of the guideline-based treatment to~     reduce the area of acute ischemic myocardium.~      Patients with unstable angina pectoris and proof of acute cardiac ischemia, proof of~     myocardial dyskinesia and angina pectoris in the patient history will receive unaltered~     guideline-based therapy for acute cardiac ischemia5,6. All necessary procedures will be~     performed to stabilize patients to a hemodynamically compensated state and patients are then~     transferred to receive cardiac catheterization (angiography and angioplasty if necessary).~      After patients are stabilized Ranolazine will be given additionally to guideline based~     medication.~      The measurement of the ischemic myocardial area will be done via three functional~     echocardiographies with speckle tracking technique10.~      A statistical evaluation of ischemic myocardial area before and after treatment with~     Ranolazine/Placebo will be done after conclusion of the RIMINI-Trial to show the effect of~     Ranolazine in acute myocardial ischemia.~   "
135211|NCT01797471|"~     The investigators aim to evaluate the safety of delivering a one-time single fraction of~     Lattice Extreme Ablative Dose (LEAD) radiotherapy followed one day later by standard-dose,~     conventionally fractionated concurrent chemotherapy and radiation delivered over 6 weeks in~     patients with bulky stage III non-small cell lung cancer in the setting of a single-arm phase~     I clinical trial. The investigators hypothesize that the addition of a one-time single~     fraction of LEAD radiation is safe and feasible, and will not result in additional toxicity~     above that expected with standard-dose concurrent chemotherapy and radiation alone.~   "
135212|NCT01797458|"~     The purpose of this randomized clinical trial is to compare the clinical effectiveness of~     three treatments involving different caries management strategies (conventional restorations,~     Hall technique, and Non-Restorative Caries Treatment) to the management of class II carious~     primary molars in children (3-8 year-old).~   "
135213|NCT01797445|"~     This study will evaluate the efficacy and safety of~     elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) fixed-dose~     combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate~     (Stribild®; E/C/F/TDF) in HIV-1 positive, antiretroviral treatment-naive adults.~   "
135214|NCT01797432|"~     The investigators hypothesize that Restylane® could serve as a repair matrix which also~     maintains IL triamcinolone acetonide concentrations at higher levels for a longer period of~     time in the skin, giving a more sustained local anti-inflammatory effect and thus, arresting~     the AA process and promoting hair regrowth. Furthermore, the combination of Restylane® with~     IL triamcinolone acetonide injections may prevent a common side effect, atrophy. With the~     prevention of scalp atrophy and the preservation of higher concentrations of triamcinolone~     acetonide for longer periods of time, patients may see a better clinical response for a~     longer period of time. Quality of life may improve as the number of clinic visits decreases~     as would the number of IL corticosteroid injections.~   "
135215|NCT01797419|"~     The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of~     GS-5806 in hospitalized infants with RSV.~   "
135216|NCT01797406|"~     Water injection colonoscopy has been a generally accepted method in training the beginners of~     colonoscopy for its low pain and less cecal intubation time, the investigators would conduct~     this study to investigate advantages of this method for experienced endoscopists.~   "
135217|NCT01797393|"~     Up to now, many studies has showed that compared with air insufflation colonoscopy,~     water-related colonoscopy could shorten the cecal intubation time and relieve the pain of the~     patients,especially for training the beginners,the investigators conduct this study to~     preform the air assisted water injection colonoscopy in experienced endoscopists.~   "
135218|NCT01797380|"~     To determine the efficacy of escitalopram in treating depression in HIV seropositive women.~   "
135515|NCT01793493|"~     The Allena-Mente study is a randomized, controlled, single-blind trial assessing the efficacy~     of cognitive stimulation (CS) compared to an active control group, participating to sanitary~     education lessons (AC). This non-pharmacological intervention is delivered to Mild Cognitive~     Impairment (MCI) and cognitively healthy individuals with first-degree relative with dementia~     (NDFAM).~   "
135219|NCT01797367|"~     The purpose of this study is to find out if starting anti-retroviral therapy (ART) above 500~     cluster-of-differentiation-4 (CD4)+ cells/milliliter (mL) ('early ART group') slows the rate~     of decrease in lung function over time compared to waiting to start ART until the CD4+ drops~     below 350 cells/mL ('deferred ART group'). Lung function normally declines with age, and both~     human immunodeficiency virus (HIV) infection and ART have been shown to case a decline in~     lung function as well. Decline in lung function can be an early indicator of chronic~     obstructive pulmonary disease (COPD), a significant cause of sickness and death in people~     with HIV. In this study, lung function will be measured at baseline and every year thereafter~     by using a spirometer.~   "
135220|NCT01797354|"~     Background: The end of treatment is for cancer patients the beginning of a critical~     rehabilitation period including numerous physical, emotional, professional and cognitive~     challenges. Specific interventions adapted to this post-treatment period need thus to be~     designed. Interventions such as group cognitive-behavioral therapy and hypnosis have been~     shown to be effective. However, moderate effect sizes, no comprehensive description of the~     treatment interventions and assessments relying only on self-report measures warrant further~     investigation. This study aims to assess, in breast cancer patients at the end of treatment,~     the impact of a group intervention combining cognitive-behavioral therapy and hypnosis versus~     a group intervention on patient's adjustment and emotion self-regulation.~      Design: This is a two-armed, longitudinal, randomized controlled trial. Breast cancer~     patients finishing their radiation therapy treatment will be randomized to either an~     immediate group intervention combining cognitive-behavioral therapy and hypnosis or a group~     intervention. Patients will be assessed at three time points during the first year following~     the end of treatment: at 1 (T1), 6 (T2) and 12 (T3) months after the end of treatment.~     Patients' adjustment will be assessed through questionnaires. Patient emotion self-regulation~     ability will be assessed through their ability to respond both subjectively (self-reported~     emotional state) and objectively (heart rate) to two emotion self-regulation tasks.~      Discussion: It is hypothesized that a group intervention combining cognitive-behavioral~     therapy and hypnosis will be more effective than a group intervention. Results of this study~     will contribute to improving post-treatment care for breast cancer patients.~   "
135221|NCT01797341|"~     The present study is aimed at evaluating the impact of a switch from Prograf to Advagraf on~     renal function, trough tacrolimus levels, drug-related adverse effects and adherence in~     stable recipients of kidney-pancreas transplants. MPA pharmacokinetics will also be~     evaluated. The results of this study have the potential to change current practice.~   "
135222|NCT01797328|"~     About 28 healthy subjects are randomized to 1 hour/day of coldprovocation or to the best of~     ability to avoid feeling cold, for 6 weeks. Basal metabolic rate and magnetic resonance (for~     determination of brown adipose tissue volume) imaging are performed before and after the~     study.~   "
135223|NCT01797315|"~     Transplant recipients have a high risk to develop skin malignancies. This effect depends on~     the one hand on the immunosuppressive drugs themselves and relates on the other hand on the~     dosage. Based on the encouraging results of previous, retrospective studies on patients~     treated with Sirolimus (SRL), these patients should be switched to an immunosuppressive~     regime including SRL, decreasing the dosage of calcineurin-inhibitors or converting from~     former immunosuppression. A conversion to a SRL-based therapy is effective in~     immunosuppression and safe regarding graft and patient survival.~      This study was designed to assess whether a switch to a SRL-immunosuppressive therapy~     decreases the incidence/reoccurrence of skin neoplasm.~   "
135224|NCT01797302|"~     In this study, we will test the central hypothesis that enhancement of vitamin D status in~     obese and overweight children will improve their vascular health and their cardiovascular~     disease (CVD) and metabolic syndrome risk profile.~   "
135225|NCT01797289|"~     All patients consecutively referred with the first episode of transient and short-lasting~     loss of consciousness will have a diagnostic workup for the assessment of the most common~     causes of syncope, and will be evaluated for the presence of pulmonary embolism (PE) with the~     use of an internationally accepted algorithm including a pre-test clinical probability (PTP~     according to the method of Wells et al.) and a high-sensitivity quantitative D-dimer assay.~     If the PTP is low and D-dimer negative, PE will be excluded. All other patients will undergo~     confirmatory diagnostic tests (either computerized tomography or ventilation/perfusion lung~     scanning) in order to confirm or rule out the presence of PE.~   "
135226|NCT01797276|"~     Expanded access to DCA as continued treatment for congenital lactic acidosis.~   "
135227|NCT01797263|"~     The Pain Outcomes comparing Yoga versus Structured Exercise (POYSE) Trial is a 2-arm parallel~     group, randomized clinical trial to compare the effectiveness of a yoga-based intervention~     (YOGA) with that of a structured exercise program (SEP) for subjects with fibromyalgia. The~     study aims are: 1) to compare the interventions' (YOGA vs. SEP) effects on overall~     fibromyalgia severity at 1 month (early response), 3 months (immediate post-intervention) and~     at 6 and 9 months (sustained effects); 2) to compare the interventions effects on specific~     fibromyalgia symptoms (pain, sleep, and fatigue), functional impairment, and related outcomes~     (quality of life, psychological symptoms); and 3) to compare the cost-effectiveness of the~     interventions.~   "
135228|NCT01797250|"~     To determine accuracy specifications of the pulse oximeter in the NEO/PEDS subject population~   "
135229|NCT01797237|"~     The purpose of this study is to determine whether this two intramedullary fixations are~     effectively in the treatment of intertrochanteric fracture.~   "
135230|NCT01797224|"~     The purpose of the OTIS Autoimmune Diseases in Pregnancy Study is to monitor planned and~     unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic~     effect of these medications and to follow live born infants for five years after birth. With~     respect to fetal outcome, it is important to evaluate the spectrum of outcomes that may be~     relevant to a medication exposure during pregnancy, and these include both easily~     recognizable defects which are visible at birth, as well as more subtle or delayed defects~     that may not be readily identifiable without special expertise and observation beyond the~     newborn period.~   "
135231|NCT01797211|"~     To assess the effect of Mediterranean diet and some of its specific components (olive oil,~     non fried fish and nuts) on endothelial function in overweight and obese patients~   "
135232|NCT01797198|"~     ASP3652 is being investigated as a novel treatment for chronic pelvic pain. This is a~     two-part study to investigate the drug-drug potential of ASP3652.~      Part I of the study evaluates the effect of gemfibrozil twice daily on the single dose of~     ASP3652.~      Part 2 evaluates the effect of multiple doses of ASP3652 twice daily on the single dose of~     repaglinide.~      Subjects participating in one part of the study may not participate in the other part.~   "
135233|NCT01797185|"~     Open-label, safety study of SPARC1104 in subjects with spasticity due to multiple sclerosis~   "
135234|NCT01797172|"~     Pain management in a neck hernia relies initially on rest, physiotherapy, and/or oral~     medications. Once these treatments have failed, different alternative procedures can be~     applied to relief pain. Thermal treatment of the intervertebral disc (Percutaneous Cervical~     Nucleoplasty; PCN) is the most often applied technique on the neck with a low risk of thermal~     damage. A variety of published studies have demonstrated this treatment to be both safe and~     effective. However, treatment of the nerve root (Pulsed Radio Frequency; PRF) is also a~     popular type of pain treatment. The application of PRF is also a safe and useful intervention~     for neck pain. Although these treatment types are described in the literature, the available~     evidence for efficacy is not sufficient to allow definitive conclusions on the optimal~     therapy to be made. The purpose of this study is to investigate which technique is the most~     effective in terms of pain relief on short term in patients with contained cervical disc~     herniation: PCN or PRF?~   "
135235|NCT01797159|"~     The Investigators are looking to compare standard treatment for the management of small cell~     lung cancer (SCLC) which is prophylactic cranial Irradiation (PCI) (shown to be very good in~     patient survival) with cranial sparing PCI. Although standard of care PCI is successful in~     patient survival it also has neurologic side-effects. The Investigators are hoping the~     cranial sparing PCI has the same positive survival results with the added benefit of lowering~     neurological side-effects.~   "
135236|NCT01797146|"~     The investigators will conduct a cluster randomized controlled trial to evaluate the efficacy~     of Catheter Reminder and Evaluation program (CARE) in reducing the duration of catheter use~     and the number of infection relating to catheter use.~   "
135237|NCT01797133|"~     We will conduct a cluster randomized controlled trial to compare two antibiotic~     pre-authorization strategies (Fellow-based vs. Pharmacist-based). We believe that amount and~     duration of antibiotic consumption would be lower in the pharmacist group while the clinical~     outcome would be equivalent between two groups.~   "
135238|NCT01797120|"~     Post-menopausal women with hormone-receptor positive (HR+) metastatic breast cancer resistant~     to aromatase inhibitor (AI) therapy will be randomized to receive Fulvestrant (Faslodex) with~     Everolimus or Fulvestrant (Faslodex) with a placebo (no active ingredients).~      Fulvestrant has demonstrated activity when used as first, second, or third line endocrine~     therapy, making it an attractive therapy for combination with other agents. In addition, it~     is commonly reserved for use following disease progression on AI therapy.~      Everolimus is an orally administered drug that blocks a signaling pathway called mTOR.~     mTOR acts as a regulator for many processes in the body, including cell growth. Blocking~     this pathway may have an effect on cell growth.~      The combination of a novel class of agents (mTOR inhibitors) and an established standard~     treatment for metastatic HR+ breast cancer may potentially increase the clinical benefit by~     targeting multiple different biological pathways.~   "
135239|NCT01797107|"~     The purpose of this study is to evaluate the effect of Azasite on patients with corneal~     surface irregularity (meibomian gland dysfunction).~   "
135240|NCT01797094|"~     This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) for the~     treatment of upper facial lines (Crow's Feet Lines and Frown Lines).~   "
135241|NCT01797081|"~     This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) compared~     to placebo for the treatment of Crow's Feet Lines (Lateral Canthus Rhytides).~   "
135242|NCT01797068|"~     A large proportion of frequent ED users have Medicaid insurance. The purpose of this study is~     to evaluate the effectiveness of patient navigation for reducing Emergency Department (ED)~     visits and hospitalizations and improving patient-centered outcomes (e.g., self-reported~     health status, quality of life, access/barriers to care) among Medicaid patients who are high~     utilizers of the ED, as well as to identify best practices for engaging and providing~     healthcare services to underserved patients using patient navigation. This study will address~     needs that have been identified within the New Haven community and the local healthcare~     system, contribute to knowledge and literature surrounding the use of patient navigation to~     improve care for underserved patients and improve health system efficiency, and inform the~     design and development of programs that address these needs both locally and in other~     communities.~   "
135243|NCT01797055|"~     Atransferrinemia is a very rare disorder, which is caused by a deficiency of the protein~     transferrin. No regular treatment is available for these patients. The objective of this~     study is to investigate the pharmacokinetics, efficacy and safety of Apotransferrin~     replacement therapy in atransferrinemia patients.~   "
135244|NCT01797042|"~     The purpose of this study is to investigate the acute and chronic effects of consumption~     fructose containing sugars and glucose in a real word setting when consumed in a manner and~     amount typical in the American diet.~   "
135266|NCT01796756|"~     Miscommunication during patient handover can jeopardize patient safety and is the focus of~     Quality Improvement initiatives by many organizations. It is widely recognized that such~     miscommunication is preventable using a number of strategies identified in the literature.~      Currently, there is no formal handover process of General Internal Medicine in-patients,~     otherwise known as the Clinical Teaching Unit (CTU) at Vancouver General Hospital, which is a~     major patient safety concern. This project will implement a formal handover program and~     evaluate whether there are changes in resident satisfaction with handover, but more~     importantly, whether the investigators can improve patient outcomes.~   "
135269|NCT01796717|"~     1. To observe clinical and bacteriologic responses of different regimens of~          piperacillin/tazobactam (4.5g q6h, prolonged or intermittent infusion) for treatment of~          nosocomial pneumonia.~        2. To describe the pharmacokinetic profile of piperacillin/tazobactam (4.5g q6h, prolonged~          or intermittent infusion) in patients with nosocomial pneumonia.~        3. To assess the safety profiles of piperacillin/tazobactam 4.5g q6h, prolonged or~          intermittent infusion in patients with nosocomial pneumonia.~   "
135245|NCT01797029|"~     This is a single center, multi-site, double-blind, parallel group, placebo-controlled trial~     of the clinical efficacy of trivalent Serum Institute of India, Ltd. (SIIL)live-attenuated~     influenza vaccine (LAIV) vaccine among children aged 24 through 59 months in Bangladesh.~      Background:~        1. Burden: Within Bangladesh, community- based influenza surveillance identified 84.5~          cases/1000 children-years among children <5 years, while 10% of clinical pneumonia cases~          were influenza positive in this age group.~        2. Knowledge gap: There has never been a randomized clinical efficacy trial of the SIIL~          LAIV vaccine conducted among children in a low-income country.~        3. Relevance: Another LAIV vaccine (made by MedImmune) has been shown to have high efficacy~          against laboratory-confirmed influenza among children. The SIIL LAIV has the potential~          to be an inexpensive intervention to prevent pediatric influenza disease.~      Primary Hypothesis: In children aged 24 through 59 months in Bangladesh, LAIV is efficacious~     in reducing rates of symptomatic, laboratory-confirmed influenza (vaccine-matched strains)~     among children vaccinated with LAIV as compared to children vaccinated with a placebo through~     the first influenza season following vaccination.~      Primary Objective: To determine the efficacy of LAIV in reducing rates of symptomatic,~     laboratory-confirmed influenza virus infection (vaccine-matched strains) among children~     receiving LAIV as compared to children receiving a placebo through the first influenza season~     following vaccination (through December 2013).~      Methods: A total of 1761 children will be enrolled and randomized in a 2:1 ratio of LAIV to~     placebo beginning in March 2013. After vaccination, all children will be evaluated for~     reactions with one home visit four days post vaccination. Subsequently, all children will be~     monitored weekly for safety outcomes and illness signs at weekly field worker home visits~     through December 2013. An extended surveillance period was added to this study and, for~     participants consenting to additional follow-up, surveillance will extend through a second~     season (through September 2014). Participants with illness signs will be referred to the~     study clinic for evaluation using standardized diagnostic criteria and treatment by a study~     physician. Children meeting protocol-defined clinical Specimen Collection Criteria will have~     a nasopharyngeal wash specimen collected. Clinical specimens will be tested by Real time~     polymerase chain reaction (rRT-PCR) for evidence of influenza virus infection.~      Primary Outcome measures/variables: Vaccine efficacy will be assessed against symptomatic,~     laboratory-confirmed influenza for all circulating virus strains.~   "
135246|NCT01797016|"~     This project aims to refine previous studies including the investigators work recently~     published in August 2012 Journal Thrombosis and Thrombolysis. That study showed a~     relationship between the level of platelet leukocyte aggregates in patients with acute~     coronary syndrome. The investigators intend to compare the characteristics of platelets,~     monocytes and neutrophil data of volume, scatter and conductivity obtained from routine blood~     count level with flow cytometry results defining platelet leukocyte aggregates. The~     investigators hypothesize that there will be a direct correlation between elevated~     platelet-leukocyte aggregates and biophysical data from the blood count.~   "
135247|NCT01797003|"~     Prospective randomized study. Compare two techniques for high tibial osteotomy (HTO) for~     treatment of medial knee osteoarthritis.~      Opening wedge osteotomy using Puddu plate vs Closing wedge osteotomy using cramp fixation. We~     will compare functional results and patient satisfaction with repetitive evaluations from~     preoperatively to 2 years postoperatively.~   "
135248|NCT01796990|"~     The main objective of the study is to provide data of the effectiveness and feasibility of~     the Acceptance and Commitment Therapy in enhancing the physically active lifestyle among~     sedentary adults. The psychological and motivational factors related to physical activity and~     behavior change will also be evaluated.~   "
135249|NCT01796977|"~     This study will evaluate the effect of OxyGenesys Dissolved Oxygen Dressing in wound~     complication rates of the nipple areolar complex after a nipple sparing mastectomy.~   "
135250|NCT01796964|"~     The purpose of this study is to compare the efficacy and safety of ESBA1008 versus EYLEA® in~     the treatment of exudative age-related macular degeneration.~   "
135251|NCT01796951|"~     Regular aspirin use has been associated with a reduction in the development of a number of~     different malignancies including lung cancer. The mechanism of aspirin's cancer prevention is~     not known. This study will evaluate whether once daily aspirin use can reduce the production~     of a protein named prostaglandin E2 (PGE-2), which is known to promote cancer. Specifically,~     this study will evaluate if aspirin can inhibit the production of PGE-2 by blocking an enzyme~     named cycloxygenase-2 (COX-2). To accomplish these goals, participants will take either~     aspirin 325 mg daily, celecoxib 200 mg twice daily, or the combination of both during various~     days of this 16-day study. Urine be collected to evaluate for PGE-2 production at 4~     timepoints in this 16-day study.~   "
135252|NCT01796938|"~     To investigate the Pharmacokinetics (PK) of oral administered Lacosamide in renal impaired~     subjects and healthy subjects.~   "
135253|NCT01796925|"~     The objective of the study is to confirm the safety and efficacy in patients utilizing the~     aura6000 System for the treatment of Obstructive Sleep Apnea (OSA).~   "
135254|NCT01796912|"~     Angina which is refractory to conventional medical therapy and revascularisation is~     challenging to manage. Lipoprotein(a) or Lp(a) is a genetically determined form of~     LDL-cholesterol, elevation of which is an independent risk factor and predictor of adverse~     cardiovascular events. Lp(a) is felt to increase cardiovascular risk via its prothrombotic~     effect and by enhancing intimal lipoprotein deposition. Lipoprotein apheresis is the most~     effective treatment for raised Lp(a). Lipid lowering agents such as statins have little to no~     effect on Lp(a) levels.~      The goal of this study is to determine the impact of apheresis on clinical parameters and~     symptoms of patients with refractory angina and raised Lp(a). The investigators will conduct~     a prospective, randomised controlled crossover study of 20 patients with refractory angina~     and raised Lp(a), randomised to undergoing lipoprotein apheresis weekly for three months or~     sham apheresis weekly for three months with assessment of myocardial perfusion, carotid~     atherosclerosis, endothelial vascular function, thrombogenesis, exercise capacity, angina~     symptoms and quality of life at the beginning and end of treatment. Patients will then~     crossover to the opposite study arm with the protocol repeated. The hypothesis is that the~     above parameters will be improved by lipoprotein apheresis in patients with raised Lp(a) and~     Refractory Angina. Investigators will also test for the genotypic presence of~     apolipoprotein(a) gene (LPA) locus variants (rs10455872 and rs3798220) which are thought to~     be associated with an increased level of Lp(a) and an increased risk of coronary disease.~   "
135255|NCT01796899|"~     To investigate the bioavailability/bioequivalence of Brivaracetam oral tablets (10 mg, 50 mg,~     75 mg and 100 mg) and Brivaracetam intravenous injection (100 mg) in healthy volunteers.~   "
135267|NCT01796743|"~     A novel Cardiac MRI sequence, developed by Dr. Maria Altbach (Double Inversion radial fast~     Spin Echo T2 mapping), has been tested clinically. It demonstrated a high sensitivity to the~     heart muscle swelling (edema) in different types of heart injury, including heart attacks.~      The investigators propose to use T2-Map methodology in patients with acute heart attacks and~     to compare value of this method with other clinical and imaging parameters in predicting~     short-term (30 day) clinical outcomes of these patients.~      If successful, the project will provide an effective risk-stratification tool to identify~     patients with heart attack as a result of atherosclerotic disease, who require more~     aggressive therapeutic approach and closer follow-up after initial hospitalization.~   "
135256|NCT01796886|"~     The pupillary examination is a major component of the clinical examination and monitoring of~     brain-damaged patients in intensive care. The occurrence of abnormal size or pupillary~     reactivity is a prognostic factor of poor neurological outcome or an indicator of the~     neurological status degradation. To date, the monitoring of the pupils is clinical. The~     subjectivity of this measure and, the lack of reproducibility and definition of the~     abnormality remain as many obstacles to the development of a monitoring of early neurological~     deterioration. The recent development in pupillometer electronics allows the assessment of~     responsiveness to a calibrated light stimulus. It offers a reliable and reproducible measure~     of the pupil diameter. The pupillometers were funded by the association of  Gueules Cassées~     .~      This study aims to establish a relationship between an abnormal pupillary reactivity~     detection by the electronic pupillometer and a deterioration in neurological status of the~     patient brain-damaged in the intensive-care unit (ICU). This is considered clinically~     relevant and has been defined by a lower Glasgow Coma Score of at least 2 points for 2 hours~     or involving a therapeutic action. If this relationship is demonstrated, the temporal~     relationship between data pupillometry and the patient's neurological status remain to be~     established more precisely. This is particularly relevant in neurosurgical context and aim to~     define the status of the electronic pupillometer in intensive care but also in emergency~     rooms services, the neurovascular units or in the pre-hospital care.~      Therefore the investigators will compare the pupillometry data in two patients groups,~     defined accordingly to the appearance or absence of neurological aggravation in the first 5~     days of treatment in intensive care, time-frame defined as the maximum risk period in~     patients with brain damage. The primary endpoint is represented by the estimated area under~     the ROC curve corresponding to the last measure of the change in pupil size before the onset~     of neurological deterioration and worse for the fifth day for non-aggravated.~      Thus the investigators propose to conduct a prospective trial, aiming to record the~     diagnostic value of pupillary reactivity by the electronic pupillometer in the monitoring of~     the neurological aggravation of brain damaged patient in ICU. The duration of the follow-up~     for a subject does not exceed 5 days. The statistical analysis requires the recruitment of 90~     patients, which sets the length of the inclusions to 14 months.~   "
135257|NCT01796873|"~     Plavix (clopidogrel) is a drug that is approved by the FDA (Food and Drug Administration) to~     reduce the risk of having another heart attack by preventing platelets (blood cells that are~     important in forming blood clots) from sticking together and forming another clot. Platelet~     activity can be measured by a machine called VerifyNow.~      The purpose of this study is to see whether Hispanic women and White non-Hispanic women have~     the same platelet response to a commonly used drug, Plavix (clopidogrel). Recent studies have~     shown that platelets may be more active in Hispanics, making it more difficult to prevent~     clots from forming, even when using Plavix. In addition, studies have shown that women may~     also have more active platelets than men. There have been no studies of Hispanic women and~     the effect of Plavix on platelet activity.~   "
135258|NCT01796860|"~     The purpose of this study is to investigate the impact of a specifically designed ankle foot~     orthosis (AFO, hinged, with tamarack joint and adjustable check strap) on the spatial and~     temporal gait parameters, electromyography (EMG), and walking endurance, in select~     individuals living with MS. This orthotic is fabricated to allow ankle range of motion~     required for normal gait kinematics. Additionally, it controls forward progression of the~     tibia during the stance phase of gait. This study has three hypotheses 1. Individuals who are~     fit with the AFO will demonstrate improvements in spatial and temporal gait parameters 2.~     Individuals who are fit with the AFO will demonstrate improvements in walking endurance, and~     3. Individuals who are fit with the AFO will demonstrate improvements in muscle firing~     profiles/EMG measures.~   "
135259|NCT01796847|"~     Glycemic variability in critically ill patients is a recognized negative prognostic factor.~     The molecular mechanisms determining inter-patients variability in glucose metabolism during~     stress are not fully understood. The Phosphatase and Tensin homolog (PTEN) is known to~     influence glucose homeostasis by interfering in intracellular insulin signaling.~      Aim of this study is to ascertain whether differential expression of PTEN in critically ill~     patients correlates with glycemic variability and clinical outcome.~   "
135260|NCT01796834|"~     To evaluate the feasibility of conducting a trial of a mindfulness-based stress reduction~     (MBSR) program for patients with diabetes (DM) on measures of HbA1c, blood pressure,~     perceived stress, depression, patient self-efficacy and quality of life; and to estimate the~     effect of a MBSR program for patients with DM. It is expected that MBSR program participants~     will evidence a trend toward better clinical outcome measures of HbA1c, blood pressure, and~     standardized measures of diabetes self-management, perceived stress, depression,~     self-efficacy, and quality-of-life.~   "
135261|NCT01796821|"~     To evaluate the efficacy of SR-T100 gel by observing total clearance rate of treated baseline~     EGW(s) on the treated area.~   "
135262|NCT01796808|"~     It is believed that the average person with an eighty year old life span will walk the~     distance of the world twice in their lifetime. The foot is comprised of a specialized fat pad~     to provide shock absorption and protection against breakdown. With all the walking humans do~     however, foot fat pad breakdown is inevitable. Trauma to the foot is compounded in the~     diabetic patients due to many reasons: loss of protective sensation secondary to neuropathy,~     reduced skin hydration, decreased soft tissue elasticity, elevated blood sugars and increased~     body weight to name a few. Increased foot pressure and decreased fat pad protection are the~     main contributing factors to callus formation, foot pain and ulcer formation.~      Fat grafting is a cosmetic and reconstructive procedure that is used sometimes to help~     improve one's soft tissue thickness, shape and integrity. Autologous fat transplantation is a~     procedure using a patient's own fat that is taken by a small liposuction tube, from areas~     with a substantial amount of fat ( i.e. abdomen or thighs) and then transferred into the fat~     atrophied (decreased or worn out) area (in this case, the foot).~      The investigators are performing this research in an effort to decrease foot pressure during~     activity and to increase the soft tissue thickness of the sole of the foot during one's~     lifetime. Ultimately this could help reduce foot pain, callus formation and even ulcer~     formation. The goal of this research is to see whether fat grafting will help decrease the~     prevalence of the aforementioned foot complications. The investigators hope that by using~     one's own fat tissue, he or she may have a longer duration of relief than by using other~     methods.~      This is a randomized, cross-over designed study. Randomized means that patients will be~     enrolled by chance (like the flip of a coin) to one of two groups for the first part of the~     study. Cross-over means that, after the first part of the study or at one year, patients will~     move into the opposite group. One group will receive the fat grafting procedure with one year~     follow up (year A pathway) and the other will receive standard of care treatment from the~     patient's primary podiatrist during the first year (year B pathway). After the first year,~     patients will switch to the opposite year pathway for the next 12 months. Participation in~     this study will last approximately 24-26 months.~   "
135263|NCT01796795|"~     This phase II study is to evaluate the efficacy of SR-T100 gel in complete clearance of~     target warts at different concentrations (1.0% and 2.3% of SM in Solanum undatum plant~     extract) in patients with CW.~   "
135264|NCT01796782|"~     Primary End Point:~      - To compare the overall survival (OS) using QYHJ Granules or Xeloda as the second therapy in~     patients with metastatic pancreatic cancer.~      Secondary End Points:~        -  Compare clinical efficacy by other measures including PFS,tumor response,and changes in~          quality of life (QOL) between these two groups.~        -  Examine the feasibility and assess the side effects of treatment using QYHJ Granules in~          patients with metastatic pancreatic cancer.~   "
135265|NCT01796769|"~     Targeted population:~      Sleep apnea patients at low cardiovascular risk newly treated by CPAP~      Hypothesis:~      Six months CPAP compliance might be greater in the telemonitoring arm compared to usual CPAP~     care.~      Main goal:~      To compare 6-months CPAP compliance when Sleep Apnea patients at low cardiovascular risk are~     randomly allocated to usual CPAP care or a multidisciplinary and coordinated follow-up based~     on a telemonitoring web platform.~   "
135270|NCT01796704|"~     The study hypothesizes that an assumed cardiovascular performance reserve is physiologically~     detectable.~      High reserve at rest characterizes a healthy person while low reserve at rest characterizes~     low functional capacity e.g. heart failure. The lower the reserve the severer the morbidity.~      The reserve may be estimated through CVRI (cardiovascular reserve index) which is computed by~     an algorithm composed of physiological measurements taken during the patient visit.~      In this study the investigators evaluate CVRI capability in prediction of functional capacity~     in comparison with the clinical evaluation during the same visit.~   "
135271|NCT01796691|"~     Comparing standard treatment versus optimized antiplatelet therapy and outcomes measures.~   "
135272|NCT01796678|"~     Vaso-occlusion contributes significantly to morbidity in sickle cell disease (SCD).~     Vaso-occlusive painful episodes (VOE) are common and debilitating, causing the majority of~     emergency department visits. Currently efforts to treat painful episodes with use of~     non-steroidal pain relievers and intravenous narcotics offer symptomatic relief only, without~     targeting the underlying mechanisms of vaso-occlusion.Investigators have found that an~     arginine deficiency and low NO bioavailability occurs during painful events in SCD. Since~     arginine is the obligate substrate for NO production, and an acute deficiency is associated~     with VOE, investigators hypothesized that arginine supplementation may be a safe and~     beneficial treatment for sickle cell pain.~   "
135273|NCT01796665|"~     The objective of this study was to evaluate the efficacy and safety of Perrigo's test~     formulation of Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% compared to~     the already marketed formulation, Acanya gel in patients with acne vulgaris.~   "
135274|NCT01796652|"~     Acute pancreatitis (AP) is considered a disease requiring in-hospital treatment. We studied~     the feasibility of home management in AP.The aim of study was to compare 30 day readmission~     rates in patients with mild non-alcoholic acute pancreatitis (NAAP) randomized to home~     monitoring versus hospitalization.~   "
135275|NCT01796639|"~     The primary objective of this study is to evaluate graft survival and recipient survival~     among kidney transplant recipients in China, and also to analyze possible factors related to~     patient and graft survival.~      The secondary objective is to evaluate several secondary outcomes among kidney transplant~     recipients, such as average creatinine value, acute rejection episodes, NODM, incidence of~     BKV infection etc. At the same time analyze possible impact factors related to these~     secondary outcomes.~   "
135276|NCT01796626|"~     At least thirty (30) subjects, Fitzpatrick-Goldman Skin Type I-IV will be enrolled in 2~     clinical sites; each clinic will enroll at least 15 subjects.~      Subjects should present visible wrinkles and/or striae requiring treatment.~      Hypothesis: The M22 ResurFX 1565nm module will improve the appearance of the wrinkles by at~     least 2 grades on the Fitzpatrick-Goldman Wrinkle and Elastosis Score, and striae by at least~     50% using VAS as compared to baseline, for at least 75% of the subjects.~   "
135277|NCT01796613|"~     The study is a multidisciplinary research project and has two main aims:~        1. To determine the safety of a contraceptive vaginal ring (CVR) in women, with an emphasis~          on its effect on the vaginal microenvironment after different durations of use: the~          vaginal microbiome, biofilm formation on epithelial cells and rings, inflammation and~          immune activation in the vagina~        2. To investigate the feasibility, acceptability and adherence to vaginal ring use in~          Rwandan women, including attitudes towards a future multi-purpose vaginal ring for~          prevention of both pregnancy and sexually transmitted infections (STI).~   "
135278|NCT01796600|"~     ConeBeam scanner (CBCT) is a widely technique used for dental and maxillofacial imaging.~     Patients can be set up in a sitting or a laying position in the, Newtom 5G CBCT allowing for~     an analysis of the distal appendicular skeleton. The investigators' hypothesis is that the~     cone-beam scanner could detect and characterize fractures of the extremities similarly to a~     multidetector CT (MDCT). 150 patients over 18 years requiring a CT scan for a suspected~     distal limb fracture or a preoperative assessment will be enrolled. The primary endpointis~     based on the ability of cone-beam scanner to properly characterize the type of fracture using~     a classification derived from Maurice E. Müller (AO) classification. Secondary endpoints will~     concern the depiction of the fracture, the assessment of the soft tissues near the fracture,~     quality of images, inter and intra-operator reproducibility and tolerance of the patient for~     the examination. Patients will have a MDCT considered as the reference exam, then a CBCT.~     Exams will be anonymized and read twice by two trained radiologists with 3-6 week intervals.~     The inter-observer agreement for the diagnosis of fracture type between the two techniques~     will be evaluated by a kappa coefficient. The evaluation of diagnostic performance will be~     achieved by studying the sensitivity, specificity, negative predictive value and positive~     predictive value, and its likelihood ratio. Kappa test will be performed to evaluate the~     consistency of the characterization of the fracture and the evaluation of soft tissue near~     the fracture. A Student t test will be performed for paired data if distributions are normal,~     a Wilcoxon test if not. To assess patient's tolerance, the percentages of (painful, not~     painful) will be calculated for each technique and will be compared using the Chi2 test (or~     Fisher's exact test if the chi can not apply).~   "
135279|NCT01796587|"~     Primary objective: To evaluate compliance of LoFric Origo in a general intermittent~     catheterization (IC) population with the use of LoFric Origo, by means of a subjective~     assessment scale~      Secondary objectives:~        -  To evaluate the subject's perception associated with the use of the LoFric Origo, by~          means of a subjective assessment scale~        -  To evaluate the subject's discomfort associated with the use of the LoFric Origo, by~          means of a subjective assessment scale~        -  To observe and collect data on bladder regimen/IC frequency by assessments of~          descriptive data of demography, catheter therapy, history and other patient reported~          outcomes.~      Study Design: Non-interventional study, multicentre, prospective study. Target Subject~     Population: General intermittent catheterization, LoFric Origo male users.~      Medical Device: LoFric Origo~      Study Variable(s):~        -  Primary variable: Use or No use of LoFric Origo after 8 weeks.~        -  Secondary variable(s): patient reported questionnaire with regards to perception,~          discomfort, diagnose, health status, catheter history and other patient reported~          outcomes.~   "
135280|NCT01796574|"~     This research is being done to observe the safety, tolerability, side effects, and~     effectiveness of the ketogenic diet in people with continuous seizures (status epilepticus)~     being treated in a neurointensive care unit.~   "
135301|NCT01796301|"~     The primary objective of the study was to evaluate the effect of 12 months of treatment with~     romosozumab compared with teriparatide on total hip bone mineral density (BMD) in~     postmenopausal women with osteoporosis who were previously treated with bisphosphonate~     therapy.~   "
135957|NCT01787643|"~     The purpose of this research study is to determine whether height-adjustable desks change~     sitting and standing time at work and away from work, engery expenditure, dietary intake, and~     body composition. Intermittent peroids of standing made possible by height-adjustable desks~     may help to impart long-term health benefits.~   "
135281|NCT01796561|"~     Cardiovascular disease (CVD) is the leading cause of death in New Zealand (40% of all~     deaths). 37% of New Zealanders suffer from high blood pressure (World Health Organisation~     2008 figures), a well established modifiable risk factor for CVD. Above 115/75 mmHg, CVD risk~     doubles for each increment of 20/10 mmHg that blood pressure is raised. An increase in BMI~     and waist circumference has been associated with an increase in blood pressure. The leaves of~     the olive plant are rich in plant compounds known as polyphenols. This particular group of~     polyphenols are known secoiridoids, which are also present in olive oil and olives though at~     lower concentrations, are only found in this family of plants. Diets high in polyphenols have~     been found to reduce the risk of chronic diseases. Studies have shown that consumption of~     phenolic-rich olive leaf extract (OLE) can significantly reduce blood pressure in individuals~     suffering from high blood pressure (hypertension), with the magnitude of effect being~     comparable to a commonly used antihypertensive drug. In such trials OLE also resulted in an~     improved blood lipid (a reduction in total and LDL cholesterol and triacylglycerides) which~     also reduces CVD risk. One study testing the effect of OLE on individuals with mild or~     prehypertension (i.e. those with systolic blood pressure in the range 121-139 mmHg and~     diastolic blood pressure in the range 81-89 mmHg but not taking antihypertensive medication)~     also found these same improvements. OLE has been indicated to have the potential to improve~     other cardiovascular risk markers such as vascular function, inflammation, platelet~     aggregation, oxidation of LDL and glucose tolerance however much of this evidence is derived~     from animal, in vitro and ex vivo studies and so well designed and controlled human studies~     are required to verify that these findings are applicable to humans. Therefore OLE~     supplementation may be a useful dietary strategy for reducing CVD risk in a cohort of~     overweight prehypertensive individuals.~      The aim of the study is to determine the effect of OLE intake on blood pressure and other CVD~     risk markers in overweight subjects with mild hypertension and to link any study outcomes~     with the presence of OLE phenolics in urine~   "
135282|NCT01796548|"~     The purpose of this study is to evaluate the effects and tolerability (how well a participant~     can stand a particular medicine or treatment) of flexible dose Oxybutynin Extended-Release~     (OXY-ER, Lyrinel) including safety and quality of life assessment in participants with~     neurogenic detrusor overactivity (NDO - the nerves mediating the detrusor muscle do not work~     properly leading to frequent feeling of need to urinate during the day, night, or both).~   "
135283|NCT01796535|"~     This is a multi-center, non-randomized post marketing surveillance registry including up to~     125 patients treated with the PerX360º System™. Patients will receive a follow-up evaluation~     at the per physician defined time points: at discharge, an Interim 1 visit (1 month), an~     Interim 2 visit (3-6 months) and a Final visit (12 months). Imaging obtained at visits should~     be per standard of care.~   "
135284|NCT01796522|"~     Hypothesis: Both nifedipine or progesterone are widely used in clinical practice as~     maintenance tocolytic therapy after an episode of threatened preterm delivery. Nevertheless,~     there is insufficient evidence to justify its routine use. The present study aims to evaluate~     the efficacy and safety of these tocolytic drugs for maintenance tocolysis in the management~     of threatened preterm delivery.~      Materials and methods:~      Phase III clinical trial, which evaluates the efficacy and safety of nifedipine and~     progesterone as maintenance tocolytic therapy until the 34th week of pregnancy in randomized~     women after an episode of threatened preterm delivery.~      Pregnant women with singleton pregnancies are going to be evaluated, with intact membranes~     and cervical length less than or equal to 25 mm, which have received acute tocolysis with~     atosiban. They will be randomized to receive maintenance tocolysis with nifedipine (60 mg /~     day orally) or progesterone (200 mg / day vaginally) until week 34 of gestation. Therefore~     all included patients will receive treatment with proven but not agreed efficacy, to decrease~     the recurrence of threatened preterm delivery, prolongation of gestation and subsequent~     better perinatal outcome. During the course of pregnancy, patients will be monitored in~     outpatient obstetrics, thus checking an adequate compliance. Monitoring will continue until~     the end with the delivery and collection of newborn data.~      The study will be single-blind, since there will be a blind evaluator. The drugs or~     treatments not allowed before and / or during the clinical trial are those which are~     indicated in the data sheet for each drug. If the patient takes antihypertensive treatment~     and continues it during pregnancy, dose adjustment will be done if it is needed.~      Data will be collected in the case report data (CRD). The end of the test will be considered~     when the last recruited patient complete the gestation (delivered vaginally or cesarean), and~     all data from newborn are collected. If a serious adverse event occurs in a patient, the~     woman will immediately finish the clinical trial and will be followed until complete~     resolution of the episode.~      Treatment is going to be considered effective if the birth occurs after 37 weeks of pregnancy~     with satisfactory perinatal outcome. The drugs are going to be considered safe if they do not~     cause adverse events in pregnant women, or if they are not serious.~      Number of Subjects: 50 pregnant women~      Diagnosis and main criteria for inclusion and exclusion:~      Inclusion Criteria~        -  Pregnant women with singleton pregnancies and intact membranes which have passed an~          episode of threatened preterm delivery (uterine contractions with cervical change)~          successfully treated with atosiban as acute tocolytic therapy.~        -  Cervical length ≤ 25 mm. Exclusion Criteria~        -  ≥ 3 cm cervical dilation, multiple pregnancy, maternal medical contraindication to~          tocolysis with nifedipine, atosiban or progesterone, or obstetric contraindication to~          tocolytic treatment (severe preeclampsia, intrauterine infection, placental abruption,~          fetal abnormality incompatible with life, fetal death) .~      Investigational product, dose and mode of administration: After a successful treatment of~     acute preterm labor with atosiban, is will be compared the safety and efficacy of maintenance~     tocolytic therapy with nifedipine 60 mg / day orally or progesterone 200 mg / day vaginally.~      Therapeutic group: C08CA05 Nifedipine. G03DA04 micronized progesterone.~      Route of administration: nifedipine orally. Progesterone vaginally.~      Dose: Nifedipine 60 mg / day. Progesterone 200 mg / day.~      Duration of treatment: From the resolution of acute episode of threatened preterm labor until~     34 weeks of gestation.~      Reference treatment, dose and mode of administration: Current evidence questions the utility~     of maintenance tocolytic therapy. No reference treatment is currently defined.~   "
135285|NCT01796509|"~     Study Hypothesis:~      Critical illness is associated with long-term medical and psychological sequelae that can~     impact the professional and private life. The purpose of the present multicenter randomized~     controlled trial is to assess whether or not a medical, psychological and social follow-up~     improves quality of life of critically ill patients at one year after their discharge from~     intensive care unit (ICU).~      Primary Purpose:~      Death or severe alteration of quality of life assessed with help of EQ5D questionnaire at one~     year after ICU discharge.~   "
135286|NCT01796496|"~     The purpose of this study is to analyze the effectiveness of a three manipulative therapy~     techniques in People with Chronic Low Back Pain.~   "
135287|NCT01796483|"~     Deep brain stimulation (DBS) of the subthalamic nucleus (STN) remarkably improves motor~     functions in patients with Parkinson disease (PD). However, growing evidence suggests that~     STN-DBS also causes executive inhibitory deficits and impulsive behaviour (Jahanshahi et al~     2000; Schroeder et al 2002; Hershey et al 2004; Thobois et al 2007; Frank et al 2007;~     Ballanger et al., 2009). Despite a widespread use, the mechanisms of action of STN-DBS are~     still unclear. Two reasons might explain this. 1) From a theoretical point of view, cognitive~     models of executive control mechanisms are incomplete. 2) From a methodological point of~     view, investigating cerebral activity during STN-DBS is very limited because most techniques~     are incompatible with locally implanted electrodes.~      This project relies on a double opportunity to answer these questions offered by recent~     theoretical and methodological advances. First, investigations in healthy subjects (Jaffard~     et al 2007, 2008, Boulinguez et al 2009) revealed an essential function of inhibitory~     control, so far ignored, consisting in locking in advance movement triggering processes to~     prevent undesired automatic or anticipated responses to unattended stimuli. In other words,~     key processes of executive control may act tonically before stimulation occurs, calling brain~     imaging studies to look at proactive and not only reactive activations. Second, recent~     advances in EEG signal processing now allow suppressing from the electroencephalogram~     DBS-related artifacts (Allen et al. 2010), providing a tremendous opportunity to use a~     non-invasive technique with the high temporal resolution necessary to disentangle proactive~     from reactive brain activity. To our knowledge, up to date no study has been published using~     EEG with STN-DBS patients since Allen et al.'s paper. The first operational purpose of this~     project is to identify the anatomo-functional origin of STN-DBS-induced executive dysfunction~     using EEG recordings in classical stimulus-response tasks. Results expected from this first~     part of the project may help resolving other long-lasting issues. Indeed, reactivity as~     assessed by simple reaction time in non-implanted patients as well as impulsivity in STN-DBS~     patients are known to remain insensitive to dopaminergic medication. Since the proactive~     activity related to executive, inhibitory, control may be supported by the noradrenergic (NA)~     system, the second purpose of this project is to test the original hypothesis according to~     which NA plays a central role in both akinesia and STN-DBS side effects.~   "
135288|NCT01796470|"~     This study will evaluate the efficacy, safety, tolerability, and pharmacodynamics of~     entospletinib and idelalisib. Participants will be enrolled who have one of the following~     hematological tumor types: chronic lymphocytic leukemia (CLL), follicular lymphoma (FL),~     mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), or non-FL indolent~     non-Hodgkin lymphomas (iNHL; including lymphoplasmacytoid lymphoma/Waldenström~     macroglobulinemia [LPL/WM], small lymphocytic lymphoma [SLL], or marginal zone lymphoma~     [MZL]).~   "
135289|NCT01796457|"~     This is an ancillary to the NIDDK-sponsored treatment trials titled: Combination Therapy of~     Pegylated Interferon Alfa-2a and Tenofovir Versus Tenofovir Monotherapy in Chronic Hepatitis~     B (NCT01369212) and Combination Entecavir and Peginterferon Therapy in HBeAg-Positive~     Immune-Tolerant Adults With Chronic Hepatitis B (NCT01369199).~      This study will examine the balance between immune regulatory and effector responses in~     hepatitis B-infected participants enrolled in the HBRN's clinical trials (NCT01369212 and~     NCT01369199) to define natural history and treatment outcome.~   "
135290|NCT01796444|"~     The recently randomized trial (ASCOG Z0011) support that among patients with limited sentinel~     lymph node (SLN) metastatic breast cancer treated with breast conservation and systemic~     therapy, the use of sentinel lymph node biopsy (SLNB) alone compared with axillary lymph node~     dissection (ALND) did not result in inferior survival. These patients, therefore, are~     unlikely to benefit from further surgery that results in a longer period of hospitalization,~     higher costs and higher postoperative morbidity. This result has been written in the 2012~     National Comprehensive Cancer Network Clinical Practice Guidelines.~      However, Limitations of Z0011, such as failure to achieve target accrual and possible~     randomization imbalance favoring the SLNB-alone group, must be considered. In the other hand,~     further testing in different country are needed.~      The investigators design and begin a prospective randomized multicenter phase III study of~     ALND vs. no ALND in breast Cancer with positive SLN--the validation of Z0011 in China.~   "
135291|NCT01796431|"~     The purpose of the study is to look at the levels of three HIV medications: tenofovir,~     emtricitabine, and rilpivirine in blood after the drug intake has been stopped in order to~     understand how long these drugs persist in the blood. The study will specifically look at~     blood levels of these three drugs (taken as a 3-in-1 tablet) after taking them every day for~     14 days.~      The duration of the subjects involvement in the study will be up to 23 days plus a screening~     visit which will take place up to 4 weeks prior to the start of the study, and a follow up~     visit which takes place 16-22 days after the last dose of study medication.~      This study is not randomised which means that all participants will receive all study~     medications in the same order. The participant and the study doctor will know which study~     medications you are taking at all times during the study.~   "
135292|NCT01796418|"~     Diabetic nephropathy, the leading cause of end-stage renal disease in many countries, is~     characterized by high cardiovascular mortality and morbidity even in the early course of the~     disease. In addition, cardiovascular complication has been the most common cause of death in~     these patients. Thus, early detection and appropriate intervention for this highly common and~     critical complication is considered to play an important role in the management of the~     disease. In this regard, much interest has been focused on the early markers which can~     predict arterial diseases before the clinically apparent cardiovascular diseases. Recently,~     glowing evidence suggests that arterial stiffness as assessed by pulse wave velocity (PWV)~     may serve as a surrogate marker for future cardiovascular disease. In fact, increased PWV has~     been known to be independently associated with diabetic nephropathy in type 2 diabetes.~      Beraprost sodium (BPS) is a stable orally active prostacyclin (PGI2) analogue that has a~     potent vasodilatory and anti-platelet effect. Also, BPS has been suggested to improve a~     micro-vascular circulation through a reduction of red blood cell deformability. In addition,~     recent studies have demonstrated that BPS improves endothelial function through an increase~     in endothelial nitric oxide synthesis and NO synthase gene transcription. These beneficial~     effects of BPS have been known to reduce PWV in patients prone to cardiovascular diseases~     such as elderly, hypertension, or a history of cerebral infarction. However, the effect of~     BPS on arterial stiffness in patients with diabetic nephropathy remains elusive. Our study~     will address the effect of BPS on arterial stiffness by PWV in patients with diabetic~     nephropathy.~   "
135293|NCT01796405|"~     This research study is a Phase II clinical trial. Phase II clinical trials test the~     effectiveness of an investigational drug to learn whether the drug works in treating a~     specific disease. Investigational means that the drug is still being studied and that~     research doctors are trying to find out more about it-such as the safest dose to use, the~     side effects it may cause, and if the drug is effective for treating different diseases. It~     also means that the FDA has not yet approved clofarabine for your disease.~      Clofarabine is a chemotherapy drug that has been used in the treatment of leukemia in~     children and adults. Information from other research studies suggests that this drug may also~     be effective in patients with LCH.~      The purpose of this study is to estimate the response rates of participants with recurrent~     LCH to clofarabine within each of two strata: a) low-risk participants with disease~     reactivation, and b) high-risk participants with risk-organ involvement.~      Other purposes are to estimate the progression-free survival after clofarabine treatment,~     estimate survival of participants with refractory multi-system LCH with risk organ~     involvement treated with clofarabine and to describe toxicities of clofarabine in~     participants with LCH.~   "
135294|NCT01796392|"~     The purpose of this research is to study an investigational medical device that is designed~     to produce lung volume reduction in diseased areas of the lungs in patients with severe~     emphysema.~   "
135295|NCT01796379|"~     Compared to end-stage heart failure, a patient's situation is usually greatly improved after~     a heart transplant (HTx), but the exercise capacity remains sub-normal, also long-term,~     ranging from 50 to 70% in most studies. While effective rehabilitation, including regular~     exercise, is considered an effective tool of improving health related quality of life (HRQoL)~     and prognosis of cardiac patients in general, the knowledge about and the effect of different~     rehabilitation programs among HTx recipients is limited. Exercise training is considered one~     of the most central parts in rehabilitation, but the mode of exercise used in different~     studies varies considerably. It is documented that high intensity interval training (HIT) has~     superior effects compared to training with moderate intensity in cardiac and heart failure~     patients. In contrast, HTx recipients have a denervated heart, and HIT had been considered~     unphysiological. However, the investigators have recently demonstrated highly beneficial~     effects on exercise capacity, muscle strength, body composition, reduced progression of~     cardiac allograft vasculopathy and HRQoL among long-term HTx recipients. In the present study~     the investigators want to test the hypothesis that systematic aerobic exercise with high~     intensity improve exercise capacity also in newly transplanted recipients, and secondarily~     that it gives favourable effects on the heart, peripheral circulation and a better HRQoL.~   "
135296|NCT01796366|"~     This trial is conducted in Europe. The aim of the trial is to investigate the safety,~     tolerability, pharmacokinetics (the exposure of the trial drug in the body) and~     pharmacodynamics (the effect of the investigated drug on the body) of NNC0123-0000-0338~     (insulin 338) in subjects with type 2 diabetes.~   "
135297|NCT01796353|"~     The objective is to investigate the effect of a comprehensive sexual rehabilitation program,~     consisting of a psycho-educative component and a physical exercise component.~      The primary hypothesis is that, a comprehensive sexual rehabilitation program improves sexual~     function.~   "
135298|NCT01796340|"~     The primary objective of the study is to investigate the effectiveness of two intensive~     two-session trainings, the conventional psycho-education and food cue exposure, on eating in~     the absence of hunger, binge eating and Body Mass Index (BMI) change in overweight/ obese~     children.~   "
135299|NCT01796327|"~     This study aims to determine the proportion of study drug dacomitinib or PF-00299804, that is~     taken up from the digestive tract into the body when given as an oral tablet compared with~     that taken up by an intravenous dose.~   "
135300|NCT01796314|"~     Therapeutic education expands in Alzheimer's Disease management in France. Several studies~     revealed a positive impact on caregiver's burden and/or quality of life. The purpose of this~     study, is to determine whether a therapeutic educational programme for both AD patients and~     primary caregivers, in community dwelling, improves patient's quality of life.~   "
135302|NCT01796288|"~     This was a multi-center randomized controlled Phase II clinical trial. Patients with~     oligometastatic stage IV (number of distant metastases ≤ 5) non-squamous non-small cell lung~     cancer treated with second-line erlotinib150mg daily for 3 months with clinical benefits~     (free-from progression) were randomized (stratified according to smoking status and different~     research centers) to the radiotherapy group (n = 100) and the non-radiotherapy group (n =~     100). Radiotherapy group (experimental group) patients started simultaneously radiotherapy~     for all gross tumors soon after randomization; non-radiotherapy group (control group)~     received no radiotherapy for all gross tumors. Erlotinib was continuously used until to~     disease progression or unbearable adverse effect, and the subsequently further salvage~     therapies were determined by the investigators. The primary endpoint was PFS.~   "
135303|NCT01796275|"~     The School of Public Health of HKU collaborates with the Hong Kong Council of Social Service~     (HKSCC) to conduct a district-based mega-project Happy Family Kitchen, which using eating~     and the kitchen as a platform, to make the effort to improve effective communication in~     Hong Kong families.~      The HFK 2 project is a enhanced version of HFK project, which plan to be conducted in the~     Tsuen Wan, Kwai Chung and Tsing Yi district from August 2012 to August 2013. This project~     adopts a cluster-randomized controlled design, with the application of positive psychology~     concepts as a theoretical framework. A community-based participatory (CBP) approach, which is~     an effective way to engage public health researchers and community members (NGOs, schools,~     other major stakeholders, and participants), will be used. Both quantitative and qualitative~     methods will be used in the evaluation of major outcomes (participants' family relationship~     and 3Hs) at different time points throughout the project. Process evaluation will be~     performed to evaluate the process of each component of the project. The whole project~     includes two phases:~      Phase 1: Model enhancement- an enhanced model of project is started with the training the~     trainer workshop to build capacity among the community partners. After that, the trained~     community partners design and conduct the district-based intervention programmes by using one~     of the five themes of the positive psychology framework, which teach the participants to~     practice positive behaviors for improving family communication, and in turn promote the 3Hs.~     The five themes are joy, flow, gratitude, savoring and listening. The pre-, post-, 4 weeks~     and 3 month follow up questionnaire surveys are conducted to assess the effectiveness of the~     programmes. All of the participating NGOs and schools will be randomly allocated into three~     groups:~      Intervention arm 1: core session intervention + booster intervention; Intervention arm 2:~     only core session intervention; Control arm: waiting list control, only questionnaire~     evaluations can be conducted at different time points.~      A subsequent qualitative study is conducted to further explore the outcomes, the problems and~     the requirements from the programmes.~      Phase 2: Model scaling up- A series of Professional Tool Kits consist of practice guides and~     evaluation tools for different service settings will be published with the contribution of~     participating NGOs and project partners. The tool kits will be the key reference and be~     further disseminated to a wider scope. A series of Professional Practice Seminars will be~     organized in different regions (including Hong Kong, Kowloon and New Territories). Social~     work practitioners of various service settings will be invited to attend the seminars. The~     evidence-based professional tool kits will be introduced and distributed in the seminar.~     Clinical psychologist will be the speaker on how to apply positive psychology in practice,~     and HKU staff will also illustrate the use of evaluation tools in assessing the outcome of~     the program. Participating NGOs of this project will be invited to share their practice~     experience in Tsuen Wan and Kwai Tsing district as well. another new edition of Happy Family~     Cookbook will be published and distributed to the whole territory. The new edition will be~     enhanced with more attractive content including healthy recipes and tips for positive~     communication etc. To enhance the interactivity of the cookbook, related apps for mobile~     devices will be developed for public free download.~   "
135304|NCT01796262|"~     The purpose of this study is to determine whether docosahexaenoic acid (DHA) is effective in~     reducing Attention Deficit/Hyperactivity Disorder (ADHD) core symptoms in a clinical sample~     of children and adolescents with ADHD.~   "
135305|NCT01796249|"~     The aim of this study is to evaluate the performance of Analgesia/Nociception Index (ANI)~     measured at the end of surgery for the prediction of immediate postoperative pain in~     postoperative care unit in adult patients undergoing general anesthesia.~   "
135306|NCT01796236|"~     To demonstrate that the minimally invasive surgical procedure in combination with the use of~     the Cochlear Baha BA400 abutment is associated with a reduction of inflammation/infection,~     overgrowth, pain and numbness at the site of implantation compared to the traditional~     surgical procedure in combination with the use of the standard Baha abutment (Cochlear Baha~     BA300 Abutment).~      To demonstrate that the minimally invasive surgical procedure in combination with the use of~     the Cochlear Baha BA400 abutment is associated with a reduction in direct medical costs, due~     to shorter surgical procedures, faster wound healing and less complications compared to the~     traditional surgical procedure in combination with the use of the standard Baha abutment~     (Cochlear Baha BA300 Abutment).~   "
135307|NCT01796223|"~     The aim of this study is to evaluate the effects of a feedback-system in psychotherapy on~     adult out-patients at a community mental health centre. It is hypothesized that the~     intervention will lead to more effective treatment, decreasing treatment dropout as well as~     improving patient-therapist relationship and patient activation in treatment.~   "
135308|NCT01796210|"~     The aim of this study is to evaluate the performance of Analgesia/Nociception Index for the~     prediction of hemodynamic reactivity in adult patients undergoing suspension laryngoscopy on~     general anesthesia.~   "
135309|NCT01796197|"~     This research study is a Phase II clinical trial, which tests the safety and effectiveness of~     an investigational drug to learn whether the drug works in treating a specific cancer. In~     this study, paclitaxel and trastuzumab are being combined with pertuzumab which is~     investigational for the preoperative treatment of inflammatory breast cancer. Trastuzumab~     is given for a total of 12 months for the treatment of HER2 positive breast cancer. This~     study also adds pertuzumab to trastuzumab so that both drugs are given for a total of 12~     months; this combination is also investigational.~      Investigational means that pertuzumab is being studied. It also means that although the FDA~     has approved pertuzumab for preoperative use to treat breast cancer, it has not been~     thoroughly studied in combination with paclitaxel and trastuzumab for preoperative treatment~     of inflammatory breast cancer. It has been FDA approved for specific use in advanced breast~     cancer that is HER2 positive.~      Pertuzumab is an antibody, which is a protein that attacks a foreign substance is the body.~     Pertuzumab blocks the function of the HER2 protein like trastuzumab does. However, pertuzumab~     binds to a different part of the HER2 receptor and stops cancer cells from growing. This drug~     has been used in the treatment of advanced breast cancer that is HER2 positive, and has been~     combined with trastuzumab and chemotherapy in those studies. Information from those other~     research studies suggests that pertuzumab may help to kill the cancer cells in the breast and~     enable you to undergo a mastectomy. The addition of pertuzumab may also help reduce the~     chance of cancer recurrence.~      In this research study, we are combining pertuzumab with paclitaxel and trastuzumab as~     preoperative therapy and will determine the response of the cancer remaining in the breast at~     the time of mastectomy. In addition, we are combining trastuzumab with pertuzumab for a total~     of 12 months and we are looking to see whether the combination reduces the chance that the~     cancer will return.~      Another goal of this research study is to determine whether we can develop a way to identify~     tumors that will respond well to this study treatment. We will do research tests on your~     tumor tissue before, during and after study treatment. These tests may help doctors~     understand how the study treatment may work to treat your type of breast cancer. In the~     future, these tests may help us find ways to help match patients with the drugs most likely~     to work against their specific tumors before treatment begins.~   "
135310|NCT01796184|"~     Background. Obesity, insulin resistance and type 2 diabetes are closely associated with~     chronic inflammation characterized by abnormal cytokine production. Some authors have found~     discordances between glycated hemoglobin (HbA1c) and other measures of glycemic control,~     suggesting that a glycation gap, defined as the difference between the HbA1c concentration~     and that predicted by the fructosamine concentration, could explain the excess~     interindividual variation in HbA1c.~      The present study was aimed to examine the association between inflammation, sociodemographic~     (age, gender) and lifestyle factors (diet, exercise, alcohol, and tobacco consumption), and~     common diseases. In addition, we also examine levels of blood glucose, HbA1c, fructosamine~     and glycation gap determining the prevalence of high glycators in a general adult~     population and their association with lifestyles and prevalent diseases.~      Methods. Selection of a random sample of the general adult population from a single~     municipality (A-Estrada, Pontevedra, Spain), stratified by age. The initial sampling includes~     3,500 subjects. Considering approximate 67% participation rate, the final study population~     would include more than 2,000 individuals. The standard workup includes structured~     questionnaires, skin prick test, periodontal examination, psychological tests, physical~     examination and blood determinations to allow for categorization of participants in terms of~     basic demographics, profession, education level, socioeconomic level, quality of life,~     physical activity, diet, alcohol consumption and smoking, atopy, obesity, diabetes, metabolic~     syndrome, hypertension, cardiovascular disease, and liver disease. We determine blood levels~     of inflammation markers, HBA1c, fructosamine and glucose. We will collect a urine sample for~     microalbuminuria determination. In addition, blood will be drawn to be stored at the Biobank~     of our Hospital. One half of participants (~1000 individuals) will undergo continuous glucose~     monitoring. The design is cross-sectional, followed by a longitudinal study using population~     registries for the determination of events (mortality).~      Discussion. This comprehensive study in a general adult population provides an excellent~     opportunity to determine serum concentrations of inflammation and glycation markers and how~     they can vary widely with age, sex, common habits, metabolic abnormalities, and chronic~     diseases. The findings from this study should also help to find out the relationship between~     glucose profiles and HbA1c and fructosamine concentrations with diet and inflammation~     markers.~      Keywords: Inflammation, glycation, glycated hemoglobin, glycation gap, continuous glucose~     monitoring, obesity, allergy, periodontal diseases, depression, metabolic diseases.~   "
135311|NCT01796171|"~     This study is a phase I/II, open-label study in patients with relapsed indolent non-Hodgkin~     lymphoma. Part A of the study included a phase I dose escalation to define the maximum~     tolerated / recommended dose for expansion of (177Lu)-lilotomab (Betalutin), and a phase IIa~     part to evaluate safety and preliminary efficacy. Part B of the study will assess the~     efficacy and safety of two different Betalutin/lilotomab dosing regimens in adult patients~     with relapsed rituximab / anti-CD20-refractory follicular lymphoma who have received 2 or~     more prior therapies.~   "
135312|NCT01796158|"~     The goal of this project is to conduct a pilot study evaluating feasibility, acceptability,~     and estimating the effect size of a new computerized Motivational Enhancement Therapy (cMET)~     intervention for alcohol-involved adolescent primary care patients.~   "
135313|NCT01796145|"~     In patients with inoperable HCC undergoing non-surgical therapy as first-line therapy~        1. We aim to determine the prognostic significance of liver stiffness in patients with HCC~        2. We aim to determine the rate and severity of complications of treatment and its~          association with liver stiffness in patients with HCC~   "
135314|NCT01796132|"~     Background: The childbearing years are a time of increased vulnerability to the onset of mood~     disorders in women and a high prevalence of exposure to antidepressant drugs during pregnancy~     and postpartum has been reported. However, the lack of information regarding the milk~     transfer and the safety of these drugs in breastfed infants and the related fear of adverse~     events for the sucking infant are some of the factors responsible for stopping prematurely~     breast-feeding or avoiding drug therapy. Selective serotonin reuptake inhibitors (SSRI) and~     selective serotonin and noradrenaline reuptake inhibitors (SNRI) are the most frequently~     prescribed antidepressant drugs during pregnancy and the post-partum period. They exhibit a~     wide interpatient variability in their concentration profiles that has been related to~     numerous environmental, stereochemical, demographic and genetic influences that might alter~     the level of exposure of breastfed newborns. Limited information is available regarding the~     safety of use of these antidepressant drugs during lactation, and is generally derived from~     small studies. A comprehensive description of their distribution and quantification in milk~     in a larger cohort of patients under various influences and the resulting impact on milk~     concentrations is lacking.~      Objectives: The current proposal addresses the primary objectives of quantifying the range of~     concentration to citalopram, escitalopram, sertraline, fluoxetine, paroxetine, fluvoxamine,~     duloxetine and venlafaxine in mother plasma and breast milk in relation to genetic~     polymorphisms, stereochemistry, demographics and environmental factors in a large cohort of~     depressive mothers. This will enable to derive the exposure to the breast-fed child taking~     into account this variability and therefore better adjust treatment to potential influences.~     As secondary objectives, we will examine the neurodevelopmental outcome of a sub-set of~     infants subjected to SSRI/SNRI in utero and/or during breastfeeding at birth, 6, 18 and 36~     months, and compared to that of a control population of infants not subjected to this~     treatment.~      Expected Results: The proposed strategy will offer new information regarding the expected~     level of drug exposure associated with each or with a combination of risk factors and help~     for optimizing the security and rationalizing the use of antidepressant treatment in~     lactating women. Hence, research on the safety of use of these drugs for the developing child~     is an area of great public health significance.~   "
135315|NCT01796119|"~     In this split-mouth controlled study, implants placed using the alveolar ridge expansion~     technique will be compared to those placed in native bone with sufficient horizontal bone~     width.~      The Piezosurgery device and Bone expanders (Mectron,Italy) will be employed in an alveolar~     ridge expansion technique.~   "
135316|NCT01796106|"~     The goal of the project is to investigate the clinical efficacy of management of early caries~     lesions by resin infiltration, which may be imaged through a SFE laser optical device~     comparable to radiographic results.~   "
135317|NCT01796093|"~     This is an investigator-started study. The trial is coded as no. GC&PJ-Dig-Iva2009-2012.~      The authors have no conflict of interest and there was no financial sponsoring The study was~     planned according to the Good Clinical Quality standards using an intention-to-treat~     analysis. The protocol was approved from the ethics committee. Selected patients gave their~     written informed consent. The family practitioners agreed and obtained the collected data and~     analysis. Analysis of collected data was performed by a single-blinded author (without~     knowledge of the used test drug and time of collection of data).~      Study Hypothesis: Compare the effect of digoxin and ivabradine in chronic heart failure with~     permanent atrial fibrillation (ischemic etiology).~      Multiple Time Frames: Primary Outcome is measured before and after each medical intervention.~      Measurements at baseline and after 3 month of therapy (twice, with the 2 different drugs):~      Measurements Severity of dyspnea. Digoxin serum concentration. ECG: Heart rate at rest and~     during 6-min walking test. Cardiac function (echocardiography): systolic function (ejection~     rate, left trial size,diastolic function.~      Participants were followed (ambulatory observation) for at least 3 months~   "
135318|NCT01796080|"~     In this randomised controlled cross-over study we will investigate whether intrathoracic~     pressure changes induced by simulated obstructive apnoea and hypopnoea trigger premature~     supraventricular and ventricular contractions as well as atrial fibrillation in patients with~     paroxysmal atrial fibrillation.~   "
135319|NCT01796067|"~     The increasing rate of obesity has become a major public health concern with national reports~     indicating 40% of African American adolescents are now overweight/obese. Little is known~     about effective weight loss interventions in ethnic minority adolescents. However, research~     has shown that ethnic minorities attend fewer intervention sessions, have higher attrition~     rates and lose less weight compared to Caucasians. Two fundamental problems related to this~     lack of progress are 1) lack of appropriate content of weight loss interventions for African~     American adolescents that integrate cultural issues, parenting skills, and motivational~     strategies for long-term change and, 2) poor dose of weight loss interventions because of~     participant fatigue and drop out. While previous weight loss studies for adolescents have~     been long lasting (12-25 weeks), our team developed a weight loss program that is a~     relatively brief (8-week) face-to-face intervention that integrates motivational~     (autonomy-support) and positive parenting skills (monitoring, social support, positive~     communication skills) for reducing z-BMI in overweight African American adolescents. Our team~     recently conducted a pilot study testing the feasibility of an 8-week on-line culturally~     tailored intervention, Thus, the goal of this project is to conduct a randomized controlled~     efficacy trial to address the problems with past studies by 1) making the face-to-face group~     intervention shorter, 2) using an on-line component to compliment the group-based~     intervention for increasing dose, and by 3) tailoring a motivational and parenting skills~     program directly to parents and adolescents skill levels and cultural background. 520~     overweight African American adolescents and their parents will be recruited to participate.~     Phase I of the trial will test the efficacy of an 8-week face-to-face group randomized trial~     comparing motivational plus family-based weight loss (M+FWL) to a basic health (BH) education~     program on reducing z-BMI and improving diet and physical activity (PA) in overweight African~     American adolescents. In phase II of the trial participants will be re-randomized to either~     an 8-week on-line intervention or a control on-line program resulting in a 2 (M+FWL vs. BH~     group) x 2 (intervention vs. control on-line program) factorial design. A 6-month follow-up~     will examine whether adolescents in the 8-week M+FWL group plus 8-week on-line intervention~     program will show the greatest maintenance in reducing z-BMI.~   "
135320|NCT01796054|"~     Mindful meditation sessions have been associated with an improvement in mindfulness,~     perceived stress, psychological well-being, anxiety, hostility, and depression. Meditation~     has been associated with a decrease in autonomic sympathetic activity, heart rate, oxygen~     consumption and energy expenditure. Randomized controlled trials of online mindfulness and~     relaxation programs have been studied in patients with conditions such as irritable bowel~     syndrome, headache, depression, fibromyalgia, and insomnia. Nurses may benefit from such~     programs given levels of job stress. This study will determine whether an online stress~     reduction program that incorporates meditation with and without concomitant group support~     reduces burnout among nurses, including emotional exhaustion and depersonalization. The~     proposed research study will utilize Stress Free Now, an online stress reduction program~     developed by Cleveland Clinic Wellness Institute.~   "
135321|NCT01796041|"~     According to the World Health Organization, breast cancer is the most common cancer in women,~     and is responsible for 686,000 new cases every year. The WHO also posit that nearly 420,000~     women perished from the disease in 2002. Surgery remains the best option for patients~     presenting with operable Stage I, II or III cancers. Breast conservation surgery has been~     shown to be as efficacious as mastectomy. About 60-70% of these women with operable breast~     cancer are breast conservation candidates. However, the need to achieve negative tumor~     margins often requires a second operation (re-excision) in up to 70% of the women having~     lumpectomy surgery. Currently, tumor margins assessment in the operating room is often~     assessed grossly by palpation. The ability to evaluate tumor margin using our proposed~     intraoperative imaging technique may provide the surgeon with an alternative, and hopefully,~     more sensitive method to assess tumor margins which may decrease re-excision and the~     morbidity associated with additional surgery, and, perhaps, lower the risk of local regional~     recurrence.~   "
135322|NCT01796028|"~     Prostate cancer is the second leading cause of mortality in men, representing 10 deaths about~     of 100 cancers (INVS 2009). Treatment for metastatic prostate cancer, when becoming resistant~     to hormone-treatment, is mostly resumed to a relatively ineffective chemotherapy~     (Docetaxel/TAXOTERE®) (1). Recently, numerous clinical and preclinical works showed that~     Metformin could represent an excellent candidate for treatment of advanced prostate cancer.~     This is a widely prescribed drug, for type 2 diabetes, with clinical advantage of exhibiting~     very rare serious side effects. On the other hand, the use of this molecule in patients was~     associated with a decrease of tumors incidence, in particular prostate cancer (2). Numerous~     in vitro and in vivo studies support its role as an anti-cancer drug, in several cell lines~     (3). These experimental results are consistent with a clinical trial pilot study, performed~     in colorectal cancer, showing anti proliferative effect of Metformin (4). In the field of~     prostate, F. Bost in J.F. Tanti's team (INSERM U895, Nice) demonstrated that Metformin~     inhibits cell viability of human prostate cancer cells, via mTOR downregulation and decrease~     tumor growth in a xenograft model (5). Furthermore, preclinical data performed by this team~     showed that Metformin increased significantly apoptosis induced by TAXOTERE®. Therefore, by~     targeting specifically cancer cell metabolism, Metformin offers new promising therapeutic~     strategy.~      The primary objective of this randomized study is to evaluate the biological efficacy of~     Metformin combination with TAXOTERE® in patients with metastatic hormone-refractory prostate~     cancer. To achieve this purpose, PSA response rate will be evaluated according to ASTRO~     definitions (Bubley, Carducci et al. 1999). Concurrently, secondary endpoints will be under~     investigation in order to evaluate the clinical response according to RECIST criteria, the~     overall and free-progression survival and the quality of life. Toxicity assessment will also~     be performed regarding to this drug combination.~      Considering the well tolerability of Metformin and the first clinical and pre-clinical data~     reports of it use in cancer treatment, combining Docetaxel (TAXOTERE®) with Metformin may~     represent a promising strategy for treatment of hormone-refractory prostate cancer.~   "
135323|NCT01796015|"~     Intracranial hypertension (ICH) is a mortality risk factor in severe traumatic brain injury~     (TBI), in purulent meningitis, in hepatic encephalopathy and in Reye's syndrome. It is also a~     risk factor for severe neurologic sequelae in survivors. Intracranial pressure (ICP)~     monitoring is likely to guide therapeutics, and certain research on adults or on children,~     suggest that IH therapeutic approach, for instance for bacterial meningitis, would improve~     the prognosis. Two monitoring techniques are currently recommended. They are reference~     methods for ICP measure :~        -  monitoring with intraventricular catheter,~        -  intra-parenchymal monitoring using optical fiber catheter. Non invasive methods have~          been suggested, including ultrasound measurement of optic nerve sheath diameter (ONSD)~          which is the most interesting one. The ONSD measured ultrasonically is correlated with~          ICP level in adults with severe TBI. A diameter over 5,9 mm predicts ICH within the~          first 24 hours. In children, ONSD average values have been worked out, and an ONSD~          increase is found in children suffering from hydrocephalus with IH and in children with~          TBI. ICH precocious detection is fundamental in children sensitive to ICH because their~          cerebral development is not finished yet. Difficulties met for ICP monitoring~          implementation in infants and its invasive nature are often disliked by clinicians. A~          non-invasive exam is then essential to allow a better care of children with ICH in~          intensive care unit.~   "
135324|NCT01796002|"~     Primary objective of the study is to compare the efficacy of romidepsin when administered~     with CHOP versus CHOP alone in subjects with previously untreated peripheral T-cell lymphoma~     (PTCL) in terms of progression-free survival (PFS) assessed according to Response criteria~     for malignant lymphoma 1999 by a Response Adjudication Committee (RAC).~   "
135325|NCT01795989|"~     The purpose of this research study is to test the use of new Magnetic Resonance Imaging (MRI)~     coils. An MRI takes pictures of body parts using a large magnet and a computer. A coil is the~     part of the MRI system that collects data to make the MR images. The investigators have~     designed, developed, and built two child-sized coils to use when imaging elbows, wrists,~     knees, and ankles. These new coils will be better suited to fit infants through teenagers~     rather than the conventional coils used which were created for adults These MRI coils have~     not been approved by the US Food and Drug Administration (FDA) and are considered~     investigational devices.~   "
135326|NCT01795976|"~     This is a trial of adoptive T cell therapy using the patient's own T cells, genetically~     engineered to target the tumour associated antigen NY-ESO-1 (New York esophageal squamous~     cell carcinoma 1). Eligible patients will undergo leukapheresis (a process to remove white~     blood cells) to retrieve sufficient T cells which will be gene modified and expanded in the~     laboratory. Patients will undergo preconditioning chemotherapy with cyclophosphamide~     (60mg/kg) day -7 and day -6, followed by fludarabine (25mg/m2) day -5 to day -1. The NY-ESO-1~     gene modified cells will be re-infused on day 0 and the patients will receive up to 14 doses~     of intravenous Interleukin2 (100000 U/kg) from day 0 to day 4.~      The primary objective of response rate according to Response Evaluation Criteria in Solid~     Tumours (RECIST) 1.1 criteria will be assessed by CT scans carried out at week 6, week 12 and~     at 12 weekly intervals thereafter.~   "
135327|NCT01795963|"~     The purpose of the present study is to examine the impact of ePREP when it is administered to~     couples. More specifically, investigators will test whether--compared to placebo~     controls--participants who receive ePREP will experience better outcomes for relationship~     relevant variables.~   "
135328|NCT01795950|"~     The purpose of this clinical study is to assess the safety of PLX-PAD to treat pulmonary~     arterial hypertension (PAH). PLX-PAD is a cell-based product made of allogeneic~     Mesenchymal-like Adherent Stromal Cells (ASCs), derived from human full-term placentas~     following an elective caesarean section. This year-long study will evaluate the safety of~     three different dose levels of PLX-PAD, each given as a single intravenous infusion. This~     study will also evaluate effects that PLX-PAD may have on PAH, such as changes in the ability~     to exercise and on other tests used to measure the disease severity.~   "
135329|NCT01795937|"~     To investigate the effect of steady-state itraconazole on the pharmacokinetics of~     steady-state of faldaprevir and the effect of steady-state of faldaprevir on the single-dose~     pharmacokinetics of atorvastatin as well as the effect of steady-state of faldaprevir on the~     single-dose pharmacokinetics of rosuvastatin~   "
135330|NCT01795924|"~     The purpose of this study is to determine whether PD-616 in combination with low-dose~     Cytarabine is safe and effective in the treatment of untreated or relapsed/refractory acute~     myelogenous leukemia (AML) or high-risk myelodysplastic syndrome (MDS).~   "
135331|NCT01795911|"~     Substudy C: The purpose of this substudy is to determine whether Lambda combined with~     Ribavirin and Daclatasvir for 12 weeks is efficacious in treatment naïve subjects with~     genotype 1b chronic HCV infection~   "
135332|NCT01795898|"~     The purpose of this study is to evaluate the efficacy and safety of fentanyl among Filipino~     participants with osteoarthritis (disorder which is seen mostly in older persons in which the~     joints become painful and stiff) and chronic (lasting a long time) low back pain.~   "
135333|NCT01795885|"~     The purpose of this study is to determine whether watching the MTV (Music Television)~     television show 16 and Pregnant could affect teen girls' attitudes about teen pregnancy,~     teen parenting, and pregnancy prevention. The investigators will recruit teen girls, ages~     15-18, who will be randomized to the intervention group (who will be asked watch 4 episodes~     of the show over a 4 week period) or the control group (who will not be intentionally exposed~     to watching the show, and will not be told which show the intervention group is watching).~     The investigators will evaluate, through survey, their attitudes about teen pregnancy and~     teen parenting before and after the intervention period, and compare the two groups at the~     conclusion of the study.~      The investigators' hypothesis is that the teens that are exposed to watching the show will~     have less favorable attitudes towards teen pregnancy and teen parenting than those teens who~     are not exposed to watching the show.~   "
135334|NCT01795872|"~     This study assesses clinical and imaging long-term data, after early or delayed~     interferon-beta-1b treatment in patients with a first demyelinating event suggestive of~     multiple sclerosis (MS), 11 years after enrollment in the Betaferon/Betaseron in Newly~     Emerging Multiple Sclerosis for Initial Treatment (BENEFIT) study (304747). The main~     objectives are to describe the disease course, change in disability, cognitive function,~     resource use and employment status, in relation to Interferon beta-1b in the long term.~   "
135335|NCT01795859|"~     The purpose of this study is to determine whether SD-809 tablets are effective in the~     treatment of chorea associated with Huntington's Disease.~   "
135336|NCT01795846|"~     The incidence of allergic rhinitis and asthma is increasing in throughout the world as well~     as our country. Allergen-specific immunotherapy has been in use for almost 100 years. Since~     then, it is recommended for the management of Immunoglobulin E (IgE)-mediated allergic~     diseases as the only immune modulator therapeutic tool. It is well documented that allergen~     immunotherapy performed using single allergen is efficacious in monosensitized patients.~     Hence, polysensitization is much more prevalent than monosensitization in patients with~     respiratory allergy. On the other hand, polysensitization may have a paramount relevance in~     clinical practice; for example, many allergists have doubts in choosing the allergen extract~     for allergen specific immunotherapy. In this regard, the evaluation of immunotherapy efficacy~     in polysensitized patients still represents an unanswered question and there are very few~     studies on this issue. However, most clinical trials of allergen immunotherapy have been~     performed with multiple different allergen extracts using sublingual route. To the best of~     our knowledge, no common single-allergen (house dust mite Dermatophagoides pteronyssinus, Der~     p) subcutaneous immunotherapy trials have been specifically designed to compare efficacy in~     monosensitized and polysensitized patients. Furthermore, few studies have demonstrated that~     monosensitized and polysensitized patients appear to differ in terms of their immune~     reactivity. But, it is unknown whether single-allergen immunotherapy protocol elicit distinct~     immune responses in monosensitized and polysensitized patients.~      The aim of this study was to investigate the immunological changes and clinical effectiveness~     of most relevant single-allergen immunotherapy in patients with allergic rhinitis and/or~     asthma. The study population will included 40 adult patients with moderate/severe perennial~     allergic rhinitis and mild/moderate asthma who were monosensitized to house dust mites or~     sensitized to at least 2 different allergens including house dust mites. No patient will~     previously had been performed allergen immunotherapy. The study plan is prospective,~     randomized, double-blind, placebo-controlled. Both groups will first received placebo~     injections for 3 months, and followed by a cluster immunotherapy schedule. After the~     maintenance dose will be reached within 6 weeks, injections will be received at monthly~     intervals. Standardized depot preparations of Der p extract (Alutard Standard Quality SQ,~     ALK-Abello (Company Name), Madrid, Spain ) were administered by means of subcutaneous~     injection. All eligible patients will underwent 8 weeks run-in period to evaluate their~     baseline clinical status based on history of allergy, symptom and medication usage for~     rhinitis and asthma, skin prick testing, pulmonary function tests and methacholine~     bronchoprovocation tests. According to the sensitizations, patients will be divided to 2~     parallel groups either as polysensitized or monosensitized. Afterwards, both patient groups~     will be followed by symptom and medication scales, visual analog scores, quality-of-life~     scores for 1 month before placebo and immunotherapy. During this period, total serum IgE,~     specific IgE levels will be measured using the method of UNI-CAP 100 (Phadia, Uppsala,~     Sweden) and repeated after placebo and immunotherapy injections. At baseline, after placebo~     (3 months) and immunotherapy injections (at third months of maintenance period), nasal~     allergen provocation test with Der p extract will applied to the study groups. Peripheral~     whole blood will drawn for the analysis of basophil activation marker CD203c (CD, cell~     differentiation) expression at this three time points. For the clinical assessment, all~     patients will record on diary cards their symptom scores, visual analog scale scores,~     medication usage, quality-of-life measures for rhinitis and asthma. On each clinical visit,~     physical examination and side effects will be collected from diary card data. In conclusion,~     we believe that this study may be help for more understanding of the immune response to~     allergen specific immunotherapy at early stage. On the other hand, if the similar clinical~     improvement is demonstrated between the two groups with common single-allergen (Der p)~     immunotherapy, unnecessary usage of multiple allergens may be prevented as well as~     therapeutic side affects and cost.~   "
135337|NCT01795833|"~     Type 2 diabetes is a major healthcare problem in the developed and developing world. Recent~     clinical trials have demonstrated that it may be prevented by lifestyle intervention focused~     on diet and physical activity. These trials have been expensive and labour intensive and this~     has limited translation of the known benefits to the population at large.~      We propose using a mobile phone intervention for lifestyle change and will assess it in a~     clinical trial(study) in people with impaired glucose regulation (high risk at developing~     type 2 diabetes).~      The study will be conducted in both India and the UK. The purpose of the study is to assess~     the effectiveness and acceptability of a text messaging system to prevent the progression to~     diabetes in people with high risk. The study involves five visits to clinic over 2 year~     period.~      Study participants will be divided into two groups by the computer generated random method -~     one is 'Usual Care' group and the other 'Text Messaging' group.~        -  Usual care will consist of a 30 minute interview, delivering personalized diet and~          exercise advice, supplemented by written material and education regarding diabetes. This~          will be delivered once at the beginning of the study.~        -  The intervention group will undergo the same initial interview and, in addition, will~          receive 3 times weekly text messaging with education, advice, support and motivation.~          These messages will be personalized to individual targets set at the initial interview.~      The primary outcome will be progression to diabetes, with and without SMS intervention.~     Secondary outcomes will be improvements in physical activity (reported and directly~     measured), body weight and other cardiovascular risk factors (blood pressure, total and HDL~     cholesterol and serum triglycerides).~   "
135338|NCT01795820|"~     Antiplatelet therapy with ticagrelor is currently indicated for treatment of patients~     presenting with acute coronary syndrome. Such therapy is started with the administration of a~     loading dose in patients which are not yet under treatment with P2Y12 inhibitors~     (antiplatelet agents). However it is unknown whether a loading dose is needed to maintain a~     satisfactory inhibition of platelet aggregation in patients who are already treated with a~     previous generation P2Y12 inhibitor (clopidogrel) during the passage to the newer compound~     ticagrelor. For this reason aim of the present study is to evaluate the levels of platelet~     aggregation during the pharmacological shift from clopidogrel to ticagrelor performed with or~     without a loading starting dose of the newer drug.~   "
135339|NCT01795794|"~     Congenital Dyserythropoietic Anemia Type I (CDAI) is a recessive autosomal disease caused by~     ineffective erythropoiesis that causes Anemia & accumulation of iron due to increased~     absorption of iron in the intestine.~      The iron is being accumulated in the body & causes damage of the liver, heart & endocrine~     glands.~      The standard follow up of iron levels is done by ferritin blood test & although the test is~     not accurate it is the most available.~      Medical treatment to removal of iron excess from the body is given in ferritin levels of~     500-1000.~      3 drugs are approved in the market:~        -  Deferoxamine, given subcutaneous during the night, 5-7 nights/week and therefore is less~          used today.~        -  Deferiprone-given 3 times a day, is a weaker chelator, although it seems like it is good~          to give it in combination with one of the 2 other drugs because it removes the iron from~          the heart's cells better.~      A rare but severe adverse effect is Agranulocytosis. This drug is usually not given in~     childbirths.~      -The 3rd drug which is mostly in use today is Deferasirox, given once daily, but has also~     adverse effects, among them- damage of liver & kidney function, damage to the digestive~     system, hearing and seeing.~      Iron is being absorbed in acidic area, & thus drugs which decrease the acidity like hydrogen~     pump's inhibitors, can inhibit the absorption of iron, and indeed there are reports that~     these drugs decrease the absorption of iron and were used as treatment to hemochromatosis as~     well.~      Those hydrogen pump's inhibitors have also adverse effects. The rarest but most severe is~     intestine infection by Clostridium.~      In children, reports of adverse effects are minimal- mostly headaches & abdominal pains and~     nosocomial infections. In adults, there are reports of fractures, magnesium deficiency &~     vitamin B12 deficiency. All in all, the adverse effects are rare & uncommon.~   "
135340|NCT01795781|"~     New anticoagulants are being introduced to replace warfarin. These drugs do not require~     monitoring and are safer. There is currently no recommended way to reverse these drugs~     rapidly in the event of undue bleeding or need for emergency surgery. This is a lab study to~     look at ways to reverse the drugs rapidly~   "
135341|NCT01795768|"~     To assess the activity of the FGFR inhibitor AZD4547 in patients with FGFR1 or FGFR2~     amplified breast, squamous lung and stomach cancer whose cancers have progressed following~     previous chemotherapy~   "
135342|NCT01795755|"~     The objective of the study is to assess the impact of horse assisted therapy (HAT) on:~        -  Addiction treatment outcomes (its effectiveness as an alternative therapy)~        -  Addiction treatment dropout & addiction relapse (its efficacy in preventing dropout).~      Hypothesis: HAT will correlate with:~        -  beneficial treatment outcomes of depression, anxiety, aggression~        -  with improved self esteem & motivation~        -  lower treatment dropout & addiction relapse.~   "
135343|NCT01795742|"~     This is an equivalence study comparing an electric nebulizer with a human-powered~     nebulizer--one that does not need electricity--in the treatment of mild to moderate asthma~     exacerbations in a regional clinic in San Salvador, El Salvador.~   "
144696|NCT01673399|"~     In this study the investigators compare the usual way of embryo transfer (without medication)~     with an embryo transfer while administering oxytocine antagonist. This to improve~     implantation and increase the pregnancy rate.~   "
135344|NCT01795729|"~     The aim of the study is to compare optimal medical therapy alone versus percutaneous coronary~     intervention on top of medical therapy in the setting of heart transplant recipient coronary~     artery disease in a randomized trial.The primary endpoint assessed at 1 year is the composite~     of death, myocardial infarction, need for transitory or permanent ventricular assist device~     implantation, myocardial revascularization, occurrence or worsening of heart failure, any~     graft dysfunction and/or a decrease of left ventricular ejection fraction of at least 25%~     compared to baseline. The hypothesis of the study is the superiority of the interventional~     management over medical therapy alone in preventing the occurrence of the primary endpoint of~     the study.~   "
135345|NCT01795716|"~     1. purpose: To conduct the relative bioavailability study of a single dose and multiple~          doses of imatinib mesylate capsule (Jiangsu Chia-Tai Tianqing Pharmacy Co. Ltd.) versus~          Glivec (Novartis Pharma Stein AG).~        2. Experimental Design： Two-period crossover design~        3. Test drug: imatinib mesylate capsule Reference drug: Glivec~        4. Sample size：20~   "
135346|NCT01795703|"~     The purpose of this study is to investigate the safety and efficacy of abiraterone in~     participants with metastatic castration-resistant prostate cancer (mCRPC) who have received~     docetaxel-based chemotherapy (treatment of disease, usually cancer, by chemical agents).~   "
135347|NCT01795690|"~     The purpose of this registry is to record information of routine treatment of anemia in~     cancer patients in Germany. An overview of the current treatment of anemia in German~     outpatient centers and hospitals will be provided. Primary outcome parameters, e.g.~     improvement in hemoglobin levels and changes in QoL, as well as patient characteristics of~     different treatments will be analyzed.~   "
135348|NCT01795677|"~     JAK2 inhibitor RUXOLITINIB before allogeneic hematopoietic stem cell transplantation (HSCT)~     in patients with primary or secondary myelofibrosis : a prospective phase II~   "
135349|NCT01795664|"~     This study will be conducted as a randomized, double blind, double dummy two period crossover~     study in stable asthma patients. A total of 16 stable asthma patients treated in accordance~     with the Global Initiative for Asthma (GINA) guidelines, will be included.~      Objectives:~        -  The primary objective of this study is to evaluate the effect of both the study drugs~          under investigation on Functional Respiratory Imaging (FRI) parameters and to evaluate~          the particle deposition in the lungs using Computational Fluid Dynamic (CFD)~        -  The secondary objectives are to assess the effect of both the study drugs on lung~          function (spirometry and body plethysmography), on exercise capacity (6 Minutes Walking~          Test = 6MWT) and on dyspnea (Borg Category (C) Ratio (R) 10 Scale and Visual Analog~          Scale (VAS) dyspnea). Furthermore the safety of the 2 products under investigation will~          be evaluated through monitoring of adverse events (AEs) throughout the study.~   "
135350|NCT01795651|"~     Medical education involves the acquisition of a large quantity of information. Lecture-based~     learning (LBL) is the best known of conventional teaching methods. Two thirds of critical~     care junior doctors identified at best only one of the three main take-home messages of a~     lecture, suggesting that knowledge transfer is poor during passive format learning.~      The investigators assess the impact of an intervention including the identification of~     take-home message of lecture with slides calling Learning Objectives, Message,~     Conclusion, in the identification of take-home message in critical care junior doctors.~   "
135351|NCT01795638|"~     Adequate growth during the neonatal period is critical for optimal long term outcomes.~     Despite maximal calorie intake, sixty percent of very low birth weight infants still fail to~     thrive suggesting that factors other than total calorie intake are important in ensuring~     consistent weight gain. Several reports have indicated a positive sodium balance is critical~     in ensuring good weight gain in very low birth weight infants, however these infants are~     susceptible to low serum sodium concentrations. Urine sodium values are sometimes used to~     diagnosis of hyponatremia or negative sodium balance after the first two weeks of life, but~     there is no evidence for this practice in preterm neonates. Our central hypothesis is that~     early supplementation with sodium will ensure positive sodium balance in very low birth~     weight infants and will result in optimal weight gain and enhanced long term outcomes.~     Secondarily we hypothesize that low sodium concentrations in the urine will not correlate~     with low serum sodium values.~   "
135352|NCT01795625|"~     The evaluation will determine professional clinical accuracy comparing the OneTouch®~     Verio™Pro+ blood glucose results with the YSI 2300 analyzer. Professional Clinical Accuracy~     is defined as accuracy of the system when used by a trained healthcare professional.~   "
135353|NCT01795612|"~     Physical exercise has been identified as a major item of many chronic diseases and cancer~     rehabilitation. It contributes to an improvement in the quality of life and to a decrease in~     the current treatment side effects and mortality. Cancer in association with treatment~     toxicity and an inactive lifestyle lead to a fall in physical capability and causes problems~     in daily activities. The physical capacity and the tolerance for exercise fall simultaneously~     leading to a deconditioning vicious circle which increases physical, psychological and~     emotional symptoms of fatigue. Therefore, physical activity for health is a valid and~     relevant way to improve quality of life and to manage cancer patient fatigue. The aim of the~     study is the assessment of the effects of a physical activity retraining program on aerobic~     capacity, strength and fatigue, in a breast cancer population treated by adjuvant or~     néoadjuvant chemotherapy.~   "
135374|NCT01795339|"~     This is a two-part multiple dose study in healthy male and female (of non-child bearing~     potential) elderly volunteers, and in Alzheimer's disease patients, to assess the safety,~     effects on the body, and blood, CSF, and urine drug levels of AZD3293. AZD3293 is being~     developed for the treatment of Alzheimer's Disease~   "
135375|NCT01795326|"~     A physician survey to document receipt of metabolic educational materials and assess behavior~     of physicians in following messages communicated through the educational materials~   "
135376|NCT01795313|"~     The purpose of this study is to see if vaccination with HLA-A2 restricted peptides, combined~     with the immunoadjuvant imiquimod is safe and can induce immune responses in children with~     recurrent ependymomas. Eligible patients are stratiﬁed by primary tumor location.~   "
135986|NCT01787266|"~     The purpose of this study is to:~        1. describe degree of symptoms and disability during and after pregnancy~        2. to examine if women with pelvic girdle pain are able to correctly mark their pain~          location on a pain drawing~        3. to examine the responsiveness of The Pelvic Girdle Questionnaire~   "
135354|NCT01795599|"~     More than 100 000 surgical abortions are annually performed in France. About four in ten~     women will have an abortion in their life. Abortion complications are cervical tearing~     (0.1-1.18%), uterine perforation (0.09-19.8‰), hemorrhage (1.5‰) and infection (5-20%). These~     complications can first compromise the vital prognosis and are involved in 10% of the~     worldwide maternal mortality (20 000 women by year), then lead to infertility which is hard~     to treat (uterine synechiae) or impossible to treat (hysterectomy for control of bleeding),~     and are finally responsible for obstetrical pathologies as late miscarriages or premature~     delivery due to cervical insufficiency. All that complications are linked to cervical~     laceration of the surgical abortion, that can be reduced by the recommended use of~     mifepristone or misoprostol as cervical preparation for the abortions after 12 weeks.~     However, it does not exist data evaluating the superiority of one of the two molecules or~     their combination. These data could optimize the cervical preparation and thus reduce the~     abortion complications with a direct impact on maternal mortality, infertility and~     obstetrical complications. Thus, it seems to be important to evaluate these two molecules and~     their combination.~      Objectives To compare mifepristone, misoprostol and their combination in the cervical~     preparation of the surgical abortion between 12 and14 weeks for their efficacy, complications~     and side-effects.~   "
135355|NCT01795586|"~     This study is being done to see how safe the combination of eribulin and carboplatin is and~     if it will work to help people with advanced breast cancer. Eribulin and carboplatin are both~     chemotherapy drugs. They work by killing cancer cells. A person is made up of cells which~     control every function in the body. Some cells stop working like they should and become~     cancer cells. These cancer cells grow and multiply rapidly and can cause destruction to~     normal body organs. Eribulin and carboplatin have both been approved by United States Food~     and Drug Administration (FDA) for use in the treatment of breast cancer. The combination of~     these two drugs and the safest dose of eribulin to use is experimental.~   "
135356|NCT01795573|"~     Clinical trial of allospecific regulatory t cells (Tregs) for prevention of acute~     graft-versus-host disease (GVHD) in human leukocyte antigen (HLA) identical sibling~     transplants.~   "
135357|NCT01795560|"~     Follow up via ultrasonic abdoman after patients who were giagnosed and treated as~     periappendicular abcess and refused to be operated later on in the interval period . To ass~     what occured to their appendics ?~   "
135358|NCT01795547|"~     To assess the effectiveness of aripiprazole once-monthly in the maintenance treatment of~     patients with a diagnosis of schizophrenia as defined by the Diagnostic and Statistical~     Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR®), in a naturalistic care~     setting by comparing it to an existing long-acting antipsychotic, paliperidone palmitate.~   "
135359|NCT01795534|"~     The study will aim to describe and evaluate the effect of beetroot juice supplementation upon~     whole body running exercise at altitude. It is hypothesised that beetroot supplementation~     will decrease time to complete a 10 km time trial.~   "
135360|NCT01795521|"~     Lung cancer is the leading cause of cancer death worldwide with a crude incidence of lung~     cancer in the European Union of 52/100.000 per year and a mortality of 47/100.000 per year.~     Non-small-cell lung cancer (NSCLC) accounts for approximately 80% of all cases. The five year~     survival of NSCLC patients is quite poor (16%), mainly due to patients being diagnosed at~     advanced stages. However if lung cancer can be detected and treated at an earlier stage the~     outcome and survival is much more favorable with five year survival rates up to 77%.~      The current standard of care for small volume tumors is surgical resection in medically fit~     patients, consisting in lobectomy or pneumonectomy accompanied by a systematic mediastinal~     lymph node sampling or lymphadenectomy. For the patient population with small volume disease~     at early stage surgery offers the potential of local tumor control in up to 96% of the~     patients.~      However, about one quarter of the patients is medically inoperable because of coexisting~     morbidities or poor general condition, mostly the result of a long smoking history and~     consecutive chronic Obstructive pulmonary disease (COPD) and coronary artery disease (CAD).~      The main purpose of this trial is to assess the effectiveness of IG-SBRT (Image guided~     stereotactic body radiotherapy) in patients with medically inoperable early stage, centrally~     located NSCLC and in those who are not willing to undergo surgical treatment.~      Secondary objectives of the study are~        -  to assess safety of the treatment modality by collecting data about acute and late~          toxicity~        -  patterns of local and distant recurrence and relation between the site of local~          recurrence and the clinical (CTV) and planning target volume (PTV)~        -  survival and cause of death~   "
135361|NCT01795508|"~     The purpose of the study is to examine the effects of Parent Management Training Oregon~     (PMTO) compared to treatment as usual (TAU) for parents with children aged 3 and 12 showing~     behavioral problems.~   "
135362|NCT01795495|"~     Significant pain may occur following posterior spinal fusion despite the use of~     conventionally accepted techniques including patient controlled analgesia. If detected, a~     significant reduction in opioid requirements may lead to improved patient satisfaction and~     decreased opiate side effects.~      The current study would use a prospective, randomized trial investigating the efficacy of one~     of 2 regimens as adjuncts to intraoperative anesthesia and postoperative analgesia, along~     with a third control group. The patients would be randomized to receive remifentanil plus a~     single intraoperative dose of methadone; remifentanil plus a bolus followed by an infusion of~     magnesium; or remifentanil alone. In addition, the two medications being studied might make~     it easier to determine the efficacy of neurophysiologic monitoring including somatosensory~     evoked potential (SSEP) (amplitude and latency) and motor evoked potential (MEP) (mA)~     required to elicit the response.~      The purpose of this study would be to explore the effects of intraoperative methadone vs~     magnesium on intraoperative anesthetic requirements, postoperative opioid requirements, the~     efficacy of neurophysiologic monitoring including SSEP and MEP, inspired concentration of~     desflurane, remifentanil, and the need for intraoperative supplemental agents to control~     blood pressure.~   "
135363|NCT01795482|"~     The study should evaluate how long patients undergoing major abdominal surgery under combined~     general/epidural anaesthesia have to be actively warmed preoperatively to prevent~     perioperative hypothermia and postoperative shivering. 99 patients will receive forced-air~     skin-surface warming for different duration. Body temperature will be measured at the~     tympanic membrane. The investigators hypothesize that active warming before starting the~     epidural anaesthesia will decrease the incidence of perioperative hypothermia.~   "
135364|NCT01795469|"~     Postural orthostatic tachycardia syndrome (POTS) is a common cause of orthostatic intolerance~     in adolescents and adults. Compression stockings are commonly recommended as a treatment~     modality for POTS, but the effects of abdominal and lower extremity compression during tilt~     table testing have not been measured in adolescent patients. The aims of our study are to~     compare heart-rate changes and symptom onset during tilt table testing (a) with and without~     abdomen/lower extremity compression and (b) with abdominal compression only versus lower~     extremity compression only. During phase 1, 20 adolescents with POTS will undergo up to 10~     minutes of tilt without compression (trial #1), a repeat study of up to 10 minutes with full~     compression (trial #2), and a third study without compression up to 10 minutes (trial #3).~     Compression will be performed using the non-inflatable Zoex anti-shock garment. During study~     phase 2, an additional 20 adolescent POTS patients will undergo up to 10 minutes of tilt~     without compression (trial #1), a repeat study of up to 10 minutes with abdominal compression~     only [n=10] or lower extremity compression only [n=10] (trial #2), and a third study repeated~     without compression up to 10 minutes (trial #3). To limit compression to the abdomen only, we~     will use the Zoex garment strap numbers 4 and 5 (thigh and abdomen) without straps 1-3 (lower~     extremities). For lower extremity-only compression, we will use Zoex garment straps 1-4~     (lower extremity and thigh) without strap 5. Data collected will include mean and peak heart~     rates and timing of symptoms with each trial. A paired-samples t-test will be used to compare~     mean heart rates between trials for each study phase. Hazard analyses will be used to assess~     time-based endpoints.~   "
135365|NCT01795456|"~     The purpose of this study is to evaluate the ability of contrast enhanced carotid ultrasound~     to serve as an indicator of disease activity in patients with Takayasu's arteritis or Giant~     Cell arteritis and to determine if patients with active arteritis have a thickening of their~     blood vessel walls compared to healthy people of the same age and gender.~   "
135366|NCT01795443|"~     The primary objective of this study is to compare the lumbar proprioception of patients with~     chronic back pain to that of healthy volunteers during low- and high-frequency muscle~     vibration.~      The order of measures (low frequency of vibration, high frequency vibration and no vibration)~     is randomized in a cross-over design.~      Patients and volunteers are matched by age and body mass index.~   "
135367|NCT01795430|"~     This pilot clinical trial studies whole-body radiation therapy, systemic chemotherapy, and~     high-dose chemotherapy followed by stem cell rescue in treating patients with poor-risk Ewing~     sarcoma. Giving chemotherapy and radiation therapy before a peripheral blood stem cell or~     bone marrow transplant stops the growth of tumor cells by stopping them from dividing or~     killing them. After treatment, stem cells are collected from the patient's blood and stored.~     More chemotherapy is given to prepare the bone marrow for stem cell transplant. The stem~     cells are then returned to the patient to replace the blood-forming cells that were destroyed~     by the chemotherapy~   "
135368|NCT01795417|"~     To evaluate the wrinkle-reducing effects of 3.25-MHz radiofrequency (RF) energy delivered in~     4 weekly applications to human periorbital skin area by grating pre- and 90-days post~     treatment photographs on the Fitzpatrick Wrinkle Severity Scale (FWSS) by three blinded~     evaluators.~   "
135369|NCT01795404|"~     A cancer diagnosis is a stressful phenomenon and a life-threatening experience that creates~     immediate psychosocial distress for the patient and his or her family. Distress is also~     experienced across the disease trajectory. Stress can manifest in a variety of psychological~     symptoms, such as anxiety and depression, intrusive cancer-related thoughts, or physical~     symptoms, such as fatigue, increased pain, and impaired sleep. Intensified stress in cancer~     patients has been associated with increased morbidity and mortality, decreased immune~     function, increased relapse, and decreased health-related quality of life. Given the known~     negative impact of stress on cancer patients, stress has become a priority issue in cancer~     treatment and research. Targeting stress-related variables with psychosocial interventions~     has been an important emphasis in cancer-care models. One of these care modalities is~     Inquiry-based stress reduction.~      The IBSR intervention, developed by Byron Katie, is a simple yet powerful process of inquiry~     that teaches the individual to identify and question the thoughts that cause him or her to~     experience stress and suffering. It is a way to understand what is hurting the individual,~     and to address the cause of his or her problems with clarity. This mindful-process, named~     The Work, facilitates that through four questions and a turnaround, which is a way of~     experiencing the opposite of what the individual believes in. The Work provides skills for~     self-inquiry and management of stressful thoughts which can be easily implemented in daily~     life. The study will focus on breast, colorectal and prostate cancer patients. These types of~     cancers have high incidence along with high survival rates.~      The primary objective is to examine the feasibility and effectiveness of IBSR for breast,~     colorectal and prostate cancer survivors on quality of life. We hypothesize that this~     intervention will lead to significant improvements in all quality of life domains (physical~     well-being, psychological well-being, social well-being etc.)~      Effects on secondary outcomes will be assessed, including depressive symptoms, anxiety and~     stress levels, and fear of recurrence. Physical symptoms (disturbance in sleeping patterns,~     fatigue, and pain), will be assessed as well. Biological measurements will be measured in~     blood samples in order to observe effects on neural and immune components.~      Additionally, we are interested in evaluating whether positive effects achieved from the IBSR~     program are modified by specific patient characteristics measured at baseline (optimism,~     social support, and spirituality).~   "
135370|NCT01795391|"~     Intravascular devices in intensive care units are often associated to complications. The~     investigators estimate that 23.5% of catheters placed and used in intensive care are subject~     to at least one complication; the goal is to demonstrate the effectiveness of the new~     Tegaderm ™ IV Advanced dressings to achieve a decrease of 35% in the number of complications~     associated with intravascular catheters in intensive care.~   "
135371|NCT01795378|"~     The protocol treatment is to evaluate clinical effects of donor-derived natural killer cells~     that are given after HLA-mismatched hematopoietic cell transplantation.~   "
135372|NCT01795365|"~     Active Surveillance manages selected men with prostate cancer expectantly with curative~     intent. This means men are carefully selected and subsequently actively observed in order to~     have the possibility to offer them curative treatment once the tumor seems to progress.~      The goal of this study is to validate the treatment option Active Surveillance in men with~     localized, well differentiated prostate cancer, in order to limit the amount of~     overtreatment. A number of key points will be studied, such as the pathological findings in~     radical prostatectomy specimens, and the effect of expectancy on the quality of life.~   "
135373|NCT01795352|"~     This is a national, multicentre, non-interventional, retrospective study to be carried out in~     the oncology settings of approximately 15-20 Spanish hospitals.~      At each participant hospital, all patients recently diagnosed with advanced EGFR mutated~     NSCLC (both newly or with recurrent disease , without previous treatment for metastatic~     disease) from April 2010 to December 2011 will be included as study population. Information~     about the follow-up of the patients during a minimum of 12 months after diagnosis will be~     collected.~   "
135377|NCT01795300|"~     In PINOCCHIO-Triayl, carbon ion radiotherapy is compared to proton and advanced photon~     radiotherapy in patients with skull base meningiomas. There will be two treatment arms with~     photons, one arm with hypofractionated photon radiotherapy, and one arm with conventional~     fractionation. The study is designed as descriptive study on feasibility of the investigated~     therapies aiming at a comparison of toxicities. The study will serve as a basis for further~     larger randomized protocols comparing efficacy of the therapies, assuming toxicity is~     comparable in all four treatment arms. Primary endpoint is toxicity, secondary endpoints are~     overall survival, progression-free survival and quality of life.~   "
135378|NCT01795287|"~     There is a elevated risk of acute compartment syndrome (ACS) related to tibial shaft~     fractures due to oedema and reduced blood flow in traumatised tissues. This may lead to lack~     of oxygen and even necrosis. Symptoms of ACS are severe pain, hypoaesthesia, pain during~     flexion of the ankle and swollen leg in clinical examination. Paralysis and lack of distal~     pulses are late symptoms of ACS.~      Many experts think that effective relief of pain caused by regional anaesthesia (RA) may hide~     the symptoms of the ACS. This may be incorrect. The evidence of dangers related to RA is~     based on old patient-series and single case-reports. Some of these studies report the~     symptoms of ACS (hypaesthesia and even pain) being caused by RA. Majority of the conclusions~     in these studies cannot be confirmed by an expert of RA. It is also possible that there are~     more hemodynamic changes related to general anaesthesia (GA) which may predispose to ACS.~     There are no modern, randomized and controlled studies of the safety of RA in patients with~     tibial shaft fracture.~   "
135379|NCT01795274|"~     The physical and biological properties of the carbon ion beam promise to improve the~     therapeutic ratio in patients with pancreatic cancer: Due to the inverted dose profile dose~     deposition in the entry channel of the beam leads to sparing of normal tissue; the Bragg peak~     can be directed into the defined target volume, and the sharp dose fall-off thereafter again~     spares normal tissue behind the target volume. The higher RBE of carbon ions, which has been~     shown also for pancreatic cancer cell lines in the preclinical setting, is likely to~     contribute to an increase in local control, and perhaps in OS. Early data from Japanese~     centers have shown convincing results. The PHOENIX-01 trial is the first trial to evaluate~     actively delivered carbon ion beams in patients with locally advanced pancreatic cancer~     within a dose-escalation strategy.~   "
135380|NCT01795261|"~     The purpose of this study is to determine if providing free laboratory test to pregnant women~     and their spouses at churches, in addition to laboratories or hospitals, will increase the~     number of pregnant women and their spouses who get screened for HIV, malaria, sickle cell~     trait, hemoglobin levels, syphilis, and hepatitis B. These tests are necessary to keep~     mothers healthy during pregnancy and lead to healthy babies. This research is taking place in~     40 churches in Nigeria.~   "
135381|NCT01795248|"~     It is well-known that women with previous gestational diabetes mellitus are in risk of~     developing type 2 diabetes later in life; approximately half of the women develop overt type~     2 diabetes within the first 10 years after pregnancy. Knowing this, we want to examine the~     effect of the type 2 diabetes medicine, liraglutide (Victoza), in women with previous~     gestational diabetes with the aim of reducing the risk of developing type 2 diabetes.~   "
135382|NCT01795235|"~     Glucagon has been used for decades as a test of growth hormone (GH) reserve. The pathway by~     which GH is stimulated by glucagon is not established. Acyl ghrelin has been shown to~     increase GH levels and to be stimulated by an increase in adrenergic activity. The proposed~     study will test the concept that with the fall in blood glucose it is likely that there is a~     sympathetic discharge which contributes to the increase in acyl ghrelin and indirectly leads~     to the increase in GH and cortisol.~   "
135383|NCT01795222|"~     Evaluation of oral midazolam to improve children's behavior and reduces the stress and~     anxiety during dental treatment~   "
135384|NCT01795209|"~     The purpose of this study is to determine the effect of ranibizumab for the treatment of~     macular edema (ME) secondary to branch retinal vein occlusion (BRVO) in patients with initial~     fair visual acuity.~   "
135385|NCT01795196|"~     Integrated pulmonary index (IPI) is a tool that monitors respiratory status. It takes into~     account four parameters: respiratory rate, end-tidal CO2, heart rate and O2 saturation using~     a pulse oximeter and specialized sidestream CO2 monitor. The device can continuously monitor~     and display the patient's ventilatory state as a single digit, 1-10. In addition, trends can~     be kept and it can provide early indication of changes in respiratory status. IPI has only~     been studied in pediatric patients who are under sedation; however, more uses for the~     monitoring tool are a possibility. One of those possibilities is to use IPI to monitor~     pediatric patients during the weaning and extubation process to determine if a specific~     number, or less than a specific number, is associated with extubation failure. Therefore,~     clinicians and physicians would be better able to determine if the patient is ready for~     extubation.~   "
135386|NCT01795183|"~     Primary Objective:~      To evaluate the effectiveness of amisulpride in Chinese patients with schizophrenia~      Secondary Objective:~      To evaluate the overall safety of amisulpride in Chinese patients with schizophrenia.~   "
135387|NCT01795170|"~     Restricting dietary lysine intake in infants from age 3 months or less with confirmed~     diagnosis of pyridoxine-dependent epilepsy due to Antiquitin (ATQ) deficiency will: reduce~     the accumulation of neurotoxic substratesα-aminoadipicsemialdehydeandits cyclic equivalent~     1-piperideine-6-carboxylate;and will improve overall neurodevelopmental outcome at 3 years of~     age by acting as an effective intervention into the complex pathophysiology of the condition.~   "
135388|NCT01795157|"~     This study aims to investigate computer based symptom assessment in an outpatient cancer~     population, and the use of a computer based decision support system to facilitate the~     diagnosis and treatment of cancer related pain.~      Primary hypothesis is, that this approach improves pain control and pain management in an~     unselected group of cancer patients in an outpatient setting.~        -  Improvement of average pain last 24 hours by at least 1.5 points on a 0-11 scale~        -  Improvement of worst pain last 24 hours by at least 1.5 points on a 0-11 scale~        -  An alteration in the prescribing dose of opioids in equipotent opioid dosage~      Secondary hypothesis is, that this system improves overall symptom control and symptom~     management in an unselected group of cancer patients in an outpatient setting.~   "
135389|NCT01795144|"~     The purpose of this study is to explore the mechanisms of metabolic control in monogenic~     diabetes patients treated with sulfonylurea medications.~   "
135390|NCT01795131|"~     Nutritional anemia is a major public health problem among children and women in developing~     countries. Despite ongoing national program of supplementing pregnant women with iron-folate,~     prevalence of anemia is 39% among pregnant women and 78% among infants in Bangladesh. Vitamin~     B12 deficiency is a more prevalent cause of megaloblastic anemia than folate in many~     developing countries. This data raises the interest to address the role of vitamin B12~     deficiency in nutritional anemia. Low dietary intake of animal products, a predominant source~     of vitamin B12 may cause anemia. Besides maintaining normal erythropoiesis, B12 is essential~     for immune function. However, no studies have evaluated the effect of maternal B12~     supplementation on reduction of anemia and improving immunity of their infants. The~     investigators hypothesize that vitamin B12 supplementation plus iron-folate during pregnancy~     and 3-mo postpartum would: (a) Decrease anemia among mothers and infants; (b) Improve vaccine~     specific cellular and humoral immune responses among mothers; (c) Improve vaccine specific~     immunity in infants by passive transfer; (d) Improve DNA methylation and one-carbon~     metabolism in mother-child pairs; (e) Reduce antenatal/postnatal depression. Results from~     this study will guide and provide support to the policy makers to identify effective~     strategies to reduce nutritional anemia in population at risk.~      The investigators aim to conduct a double-masked placebo controlled trial to investigate the~     added effect of vitamin B12 on the iron-folate supplementation among pregnant women. Anemic~     (Hb level <11.0 g/dl) mothers at 11-14 weeks of gestation will be randomized into two groups:~     supplement group will receive 250 ug vitamin B12 plus 400 ug folate and 60 mg iron; placebo~     group will receive folate and iron only. This daily supplementation will continue up to 3-mo~     postpartum. At 26-28 wk of gestation mothers will be given inactivated influenza vaccine.~     Data on anthropometric indices of mothers and children, birth size, infant growth and~     morbidity (mothers and children) throughout the study period will be recorded. 24-h dietary~     recall data will be collected from the mothers bimonthly throughout the study. Biochemical~     indicators of anemia including Hb, vitamin B12, ferritin, folate and α-glycoprotein (AGP)~     will be assessed in plasma of mothers (pre- and post-supplementation) and infants (cord blood~     and 3-months). Additional measurements include serum transferrin receptor (sTfR) in plasma~     and methyl malonic acid (MMA) and total homocysteine (tHcy) in the urine of mothers. Plasma~     vaccine specific antibody responses will be measured in mothers (pre- and post~     supplementation) and in infants (cord blood and 3-months). In breast milk, B12, folate and~     s-IgA will be determined. Genetic polymorphism (one-carbon metabolism) and DNA methylation~     will be studied in mothers and in cord blood.~   "
135391|NCT01795105|"~     This is a Post-Marketing Surveillance study of Abilify® tablets in accordance with Korean~     regulations on New Drug Re-examination (i.e. New Drug Re-examination Standards: KFDA~     Notification No. 2010-94 dated 27 December 2010).~   "
135392|NCT01795092|"~     This is a randomized, controlled study to compare patients evaluated by primary care~     physicians alone versus patients who are additionally evaluated by a dermatologist at the~     primary care physician‟s office, aiming to demonstrate that visits to the primary care~     physician‟s (PCP) office that involve both the PCP and an on-site dermatology consultation~     will reduce hospital admission rates. The hypothesis of this study is that obtaining~     outpatient dermatology consultations during a patient‟s initial presentation to a primary~     care office will reduce admissions for cellulitis with accuracy. The primary objective will~     be to measure the difference in the proportion of patients requiring hospital admission~     utilizing a dermatology consultation at the PCP‟s office (active arm) versus primary care~     evaluation alone (control arm) by calculating risk ratios and risk differences. The risk of~     admission for each arm will be assessed once the study has been completed. The secondary~     endpoint will be admission versus discharge home at a dermatology follow-up visit to assess~     accuracy of initial assessment. An additional endpoint will be to determine if any~     differences in frequencies of cellulitis and admission exist based on age and~     immunosuppression. Exploratory analyses will assess the percentage of patients with a~     concomitant known predisposing factor for recurrent cellulitis such as lymphedema, leg~     ulceration, tinea pedis, or onychomycosis, as well as the association of fever >100.5 F and a~     history of a prior episode of cellulitis.~   "
135393|NCT01795079|"~     The purpose of this study is to see the effects of transcranial direct current stimulation~     (tDCS) on the pain and itching associated with burn injury. This study is part of the~     Boston-Harvard Burn Model System. The investigators hypothesize that there will be a decrease~     in pain levels with active stimulation, when compared to sham stimulation, using a 3 week~     stimulation schedule- 2 weeks of stimulation (10 consecutive days) followed by 1 week of~     stimulation (5 consecutive days) after three follow up visits at 2, 4 and 8 weeks after~     initial course of stimulation. The subject will also have follow ups at 2, 4 and 8 weeks~     after the second course of stimulation.~      If a subject receives sham during the experiment, he/she may enroll in an open-label portion~     of the study and receive 10 days of active stimulation.~   "
135394|NCT01795066|"~     For 12 months after approvement by the University of Yonsei institutional review board, of~     the 59 patients older than 20 years referred to our medical center for EUS-FNA or FNB, all~     consecutive pancreatic lesions were evaluated for inclusion in our prospective study. The~     inclusion criteria for this study were the following: diagnosed or suspected solid pancreatic~     masses according to clinical evaluation and imaging studies with need of histologic tissue~     confirmation by EUS-FNA or EUS-FNB. The exclusion criteria were the following: cystic~     pancreatic lesions, patients haemodynamically unstable or with severe coagulopathy~     (international normalized ratio [INR] > 1.5 or platelet count < 50,000 cells/cubic millimeter~     [cmm3]), patients unable to suspend anticoagulant/anti-platelet therapy, pregnancy, inability~     or refusal to give informed consent, and refusal to participate in the study. Patients~     undergoing anticoagulant or anti- platelet therapy for non-critical problems discontinued~     treatment at least 5 days before the endoscopic procedure. Written informed consent was~     obtained from all patients for the procedures performed and participation in the study, and~     the study protocol was approved by the University of Yonsei institutional review board. All~     patients were underwent the procedure under conscious sedation with propofol and midazolam~     according to the current guidelines.8 After procedure, the patients were monitored for at~     least six hours in order to immediately detect post-procedural complications and were~     followed for up to 7 days in order to detect late complications.~   "
135395|NCT01795053|"~     A sample of 60 children is randomly assigned to an intervention and a control condition. The~     intervention group receives 15 sessions of child-focused treatment with play training to~     enhance play persistence and intensity. The control group receives the same amount of placebo~     play sessions. The intervention group receives subsequently 15 sessions of parent training.~     All children are 3 to 6 years old and meet diagnostic criteria for ADD or ADHD. Main~     hypothesis are a stronger reduction of ADHD symptoms of the child in different settings in~     the intervention than in the control group. Play-persistence and -intensity should also~     increase more in the intervention group. An additional effect of a subsequent parent training~     shall furthermore be tested.~   "
135396|NCT01795040|"~     The efficacy of PUFAs (as nutritional supplement) in/for pre-school children with ADHS~     symptoms will be evaluated in a randomised controlled doubleblind trail with children aged~     3-6 years.~   "
136026|NCT01786733|"~     The purpose of this study is to compare the effectiveness of Behavioral Activation and~     Supportive Therapy added to the standard acute psychiatric inpatient care. Therapy starts~     during inpatient care and can continue in an outpatient facility if the patients are~     discharged before 12 sessions has been completed.~   "
135397|NCT01795027|"~     Background: It is shown that TS-1 as adjuvant chemotherapy after D2 resection in patients~     with gastric cancer can improve DFS and OS in one Japanese Trial. And TS-1 has become one of~     the standard therapies to these patients. But it is still unknown whether it would improve~     more to OS and DFS than single TS-1 after combined with oxaliplatin . This trial is designed~     to investigate the efficacy and safety of TS-1 plus oxaliplatin versus TS-1 single as~     adjuvant chemotherapy after D2 resection in patients with gastric cancer.~      Patients and methods: In this study , patients with histologically confirmed gastric cancer~     who received D2 resection and staged II or III, aged from 18 to 70 years and with Eastern~     Cooperative Oncology Group performance status ≤2 and adequate organ function, are randomized~     1:1 to oxaliplatin 100mg/m2 on day 1 and TS-1 40~60mg twice everyday for 14 days in a 21-days~     cycle for total 6 cycles followed by TS-1 single with the same dose and frequency to the end~     of the 1st year postoperatively(SOX) , or TS-1 single 40~60mg twice everyday for 14 days in a~     21-days cycle to the end of the 1st year postoperatively (TS-1). The primary end point is~     overall survival (OS), and secondary end point is disease free survival(DFS) and safety.~     Final study analysis will be conducted in the end of the 5th year after the last patient's~     enrollment.~   "
135398|NCT01795014|"~     A spontaneous venous pulsation over the optic disc is an ophthalmological sign that can~     potentially be found in up to 98% of healthy individuals. In fact, the lack of this~     spontaneous retinal venous pulse has been consistently implicated as an indicator of a more~     advanced form of certain ocular diseases, specifically open-angle glaucoma. However, the~     mechanisms behind these change in the retinal venous system are not clear. Some evidence~     suggests that extraocular features such as intracranial pressure (ICP) may play a role in~     regulating the intraocular venous outflow. The reasons for this hypothetical downstream~     resistance to venous outflow are not fully understood, with advances in this field being~     limited by our technological-imposed difficulties in assessing the structures behind the~     globe.~      However, it has been established that the volume of cerebrospinal fluid surrounding the optic~     nerve correlates with the ICP at the orbital level. Recent studies have suggested that~     non-invasive ultrasound-based recordings have correlated this surrogate for orbital ICP with~     the intraocular pressure (IOP) in glaucoma patients with an otherwise normal IOP range~     (normal tension glaucoma - NTG).~      The investigators will therefore conduct a test to determine if this cerebrospinal volume~     surrounding the optic nerve correlates with the frequency of observation of an otherwise~     signal of venous dysfunction (i.e. the lack of a visible pulse in the retinal central vein)~     Additionally, the investigators will assess if this correlation is different between healthy~     individuals, hypertensive primary-open angle glaucoma or NTG patients.~   "
135399|NCT01795001|"~     The purpose of this study is to gain further insights into the molecular pathogenesis of~     Fuchs' endothelial corneal dystrophy (FECD), to identify targets for potential specific drug~     therapy.~   "
135400|NCT01794988|"~     The purpose of this study is to investigate whether a psycho-therapeutic approach, group~     Cognitive Behavioral Therapy (CBT) plus a relapse prevention program, Therapeutic Interactive~     Voice Response (TIVR), modifies the dysfunctional sensory, emotional, and cognitive neural~     circuitry associated with chronic pain.~   "
135401|NCT01794975|"~     The primary objective of the study is to further investigate whether striatal [11C]ORM-13070~     uptake can be reduced by physiological and pharmacological challenges that increase the~     synaptic concentrations of noradrenaline in the human brain. Each subject will undergo 3 PET~     scans, a baseline PET scan and two scans with noradrenaline challenges: intravenous~     administration of ketamine and oral administration of atomoxetine combined with a cold~     pressor test where the subject's foot is placed in an 8 °C water basin. Eight healthy male~     subjects will be included in the study.~   "
135402|NCT01794962|"~     This is a pilot study. Chronic LBP is a major health care problem in Denmark. Few patients~     receive a specific diagnosis, leaving the majority of patients diagnosed with non specific~     low back pain(NSLBP). Classification systems can help to guide the treatment of NSLBP. This~     pilot study will compare manual therapy (manipulation and soft tissue treatment)and exercises~     to a classification based biopsychosocial intervention (a cognitive/functional approach) as~     described by Peter O`Sullivan, on a subgroup called flexion pattern~      This pilot study has three specific aims:~      (i) To determine the mean and standard deviation on the numerical rating scale of~     participants in this setting who have a motor control flexion pattern, so that sample size~     calculations for a fully powered randomized controlled trial could be performed.~      (ii) To test the logistical and practical procedures that will be required to perform a fully~     powered randomized controlled trial using these two treatments.~      (iii) To gain a preliminary estimate of any difference in the effect of these two treatments,~     so as to determine if the results of a fully powered randomized controlled trial might be~     clinically important and therefore worthwhile undertaking~   "
135403|NCT01794949|"~     The use of drug eluting stents (DES) used to treat coronary artery blockages is limited by~     poor healing of the stented area. This will require the combined use of blood thinners such~     as aspirin and clopidogrel (i.e. dual anti-platelet therapy (DAPT)) to prevent complications~     such as clot formation on the stent which may lead to a heart attack. Diabetic patients and~     those presenting with a heart attack at the time of stent placement are at increased risk for~     clot formation. However, little is known of the healing responses after stent placement in~     these populations.~      Currently all patients receiving DES are advised to complete DAPT for twelve months although~     more personalized durations of DAPT based on stent healing would reduce both clot formation~     and potential bleeding from the blood thinners, thereby improving the long-term safety of~     DES.~      Intracoronary optical frequency domain imaging (OFDI) is a novel high resolution invasive~     imaging technique that has the ability to evaluate stent healing at follow-up. Among the~     commercially available coated stents used in the U.S., the zotarolimus eluting stents~     (RESOLUTE Integrity, Medtronic, Minneapolis, MN) has demonstrated superior healing in both~     preclinical and clinical studies.~      The purpose of this trial is to determine the healing responses of the RESOLUTE Integrity~     stent as detected by OFDI in patients with and without diabetes presenting with ACS.~     Specifically, in this observational study, the study team will investigate non-insulin~     dependent diabetics and non-diabetics in the setting of ACS and RESOLUTE Integrity stent~     placement.~      The investigators hypothesize that healing responses in patients with non-insulin dependent~     diabetes will be similar to those without diabetes presenting with ACS and that a majority of~     patients will demonstrate complete healing as determined by OFDI measurements.~   "
135462|NCT01794182|"~     This is a randomized, multi-center, prospective, double blind study. The primary objective is~     to demonstrate the efficacy of RP-1127 compared to placebo in subjects with a severe anterior~     circulation ischemic stroke who are likely to develop malignant edema. This objective will be~     addressed by comparing the proportion of RP-1127 treated patients and placebo treated~     patients with a Day 90 modified Rankin Scale (mRS) ≤ 4 without decompressive craniectomy~     (DC).~   "
135404|NCT01794936|"~     This study is designed to evaluate the use of a disposable laparoscopic Doppler probe in~     robotic assisted prostatectomies. The Vascular Technology, Inc. (VTI) laparoscopic probe is~     simply a sterile, disposable Doppler probe that can be inserted through a laparoscopic trocar~     and placed on structures to determine if there is vascular flow demonstrating an audible~     pulse. During robotic-assisted prostatectomy, identification of vasculature is critical in~     order to prevent hemorrhage and effectively treat the underlying pathology. The investigators~     routinely utilize a combined Doppler ultrasound laparoscopic probe to identify vasculature~     during renal surgery, but Doppler ultrasound usage has not been adopted for prostatic~     surgery.~      From a mechanical standpoint, these combination probes differ from the VTI probe in that they~     are approximately 2 times the diameter of the VTI probe, and the portion of the probe~     utilized for imaging much longer and on the side of the device. The VTI probe is much~     narrower, and the portion of the probe utilized for vessel identification is at the tip of~     the probe. For robotic-assisted prostatectomy, patients will be randomized to VTI~     laparoscopic Doppler System to identify pedicles and neurovascular bundles (NVB) or to~     robotic-assisted laparoscopic prostatectomy with no Doppler probe, which is the current~     standard of care.~   "
135405|NCT01794923|"~     The objective of this study is to compare the efficacy and safety of Ibuprofen 5% Topical Gel~     versus placebo administered two or three times daily for the treatment of pain associated~     with delayed onset muscle soreness following intense eccentric exercise of the elbow flexor~     muscles.~   "
135406|NCT01794910|"~     Aim: To determine the effects of pelvic floor muscle training (PFMT) in women with a single~     delivery route. Pregnancy and delivery route alter the pelvic floor muscle strength and are~     considered risk factors for urinary incontinence and genital dystopias. Methods: A Randomized~     controlled clinical trial with two hundred ninety-seven women aged 35 to 45 years old were~     selected for functional assessments of their pelvic floors by vaginal digital palpation and~     perineometry. One hundred sixty-five (69.7%) exhibited muscle strength deficits and were~     included in the clinical trial. The participants were distributed into two groups based on~     the delivery route (A, vaginal delivery and B, cesarean delivery) and were then randomly~     subdivided into Groups A1 (n = 44) and B1 (n = 42), who performed PFMT, and Groups A2 (n =~     39) and B2 (n = 40), who did not undergo muscle training. The PFMT involved perineal~     contraction exercises in the dorsal decubitus, sitting, and standing positions and was~     applied twice per week for a total of 15 sessions. The functional assessment of pelvic floor~     by vaginal digital palpation and perineometry was performed after 15 sessions of pelvic´s~     floor muscles training. The statistical analysis was performed using the Mann-Whitney and Z~     tests at a 5% level of significance.~   "
135407|NCT01794897|"~     The effects of Valacyclovir (VAV) augmentation or placebo (PLA) as adjuncts to conventional~     antipsychotic drug treatment will be evaluated among patients with schizophrenia who have~     been exposed to herpes simplex virus type 1 (HSV-1). Hypothesis: Valacyclovir (VAV)~     augmentation improves (a) cognitive and (b) overall function among Herpes Simples Virus 1~     (HSV-1) exposed early course schizophrenia patients.~   "
135408|NCT01794884|"~     In view of the lack of large-scale clinical study and potent evidence-based medicine, the~     investigators designed a randomized, double-blind, placebo-controlled study to ascertain~     whether preoperative intravenous administration with glutamine can improve the postoperative~     cardiac function and prognosis of adult patients undergoing cardiac surgery. The~     investigators want to detect the levels of myocardial protein O-GlcNAc modification and HSP70~     expression, changes in sensitive indicators of myocardial injury, systemic inflammatory~     reaction and oxidative stress levels, and to examine the correlation between these changes~     and Clinical manifestations. The ultimate goal of the study is to explore a new way for~     clinical myocardial protection.~   "
135409|NCT01794871|"~     Identify the cause of chronic allograft dysfunction using a combination of comprehensive~     clinical and histologic information in Chinese renal transplant recipients, then to identify~     the position of CNI nephrotoxicity in CAD.Chronic allograft dysfunction reflects the dual~     impact of both immunologic and nonimmunologic (primarily calcineurin inhibitor~     [CNI]nephrotoxicity) injury. In previous, CNI nephrotoxicity is overstated and considered one~     of the major causes of CAD, however, recently there has been found most death-censored graft~     losses to be the result of alloimmune or autoimmune injury, with only a minority of cases~     attributable to CNI toxicity. Unfortunately, Situation of objective CNI toxicity in CAD in~     China is not well analyzed. To improve perception of Neo safety with more local evidence, we~     want to do a retrospective study to identify the cause of chronic allograft dysfunction using~     a combination of comprehensive clinical and histologic information in Chinese renal~     transplantation recipients.~   "
135410|NCT01794858|"~     Background: Acute pancreatitis is characterized by a high mortality rate (10%-15%), and a~     remarkably unpredictable clinical course. Approximately 50% of deaths in acute pancreatitis~     occur early—within the first 14 days—and early mortality is attributable to sequelae of a~     severe systemic inflammatory response syndrome (SIRS), which is associated with multi-organ~     dysfunction syndrome (MODS) that can escalate to renal failure, respiratory failure, and~     death. Significant improvements in acute pancreatitis mortality will demand innovative~     approaches to counteract early organ failure. A series of destructive cellular processes~     begins within minutes of initial pancreatic injury, and the ensuing inflammatory cascade is~     compounded by disease sequelae including edema, ischemia, and tissue necrosis. Early~     interventions to reduce inflammation within the first 36 hours have been shown to have~     significant effects in minimizing progressive organ dysfunction.~      Hypothermia is clinically employed to combat cellular injury and systemic responses following~     ischemia-reperfusion, and is been studied as a mechanism of acute inflammatory inhibition in~     processes including cardiogenic shock, lung injury, local intestinal injury, and reperfusion~     injuries to the lung, liver, and endothelium. In numerous studies, effective~     immunomodulations have been observed including reduction of pro-inflammatory cytokines~     (TNF-α, IL-6), stimulation of anti-inflammatory cytokines (IL-10), inhibition of~     pro-apoptotic JNK signaling, reduction of systemic oxidative stress, and inhibition of~     neutrophils, monocytes, and monocyte-derived macrophages. Most saliently, in the caerulein~     model of murine acute pancreatitis, therapeutic hypothermia has been shown to reduce serum~     IL-1, IL-6, and TNF-α, increased serum IL-10, decrease serum amylase and lipase, lower the~     histological grade of pancreatic injury as compared to normothermic mice, and significant~     survival benefit. Although therapeutic hypothermia is actively employed in the treatment of~     traumatic brain injury, neonatal asphyxia, spinal cord injury, and cardiac arrest, no studies~     have yet been made of its application to acute pancreatitis.~      Hypothesis: Patients treated with therapeutic hypothermia (32-34°C) will sustain reduced~     organ-specific injury in acute pancreatitis.~      Proposal: In a Phase IIa pilot clinical trial, we will examine the effects of therapeutic~     hypothermia on organ-specific outcomes during the early stage of acute pancreatitis. We will~     recruit five patients aged 18 to 80 receiving medically-necessitated ventilator support under~     ICU monitoring with core temperatures ≥36°C and severe acute pancreatitis defined as either a~     Ranson Score ≥7, a CT indicating ≥50% pancreatic necrosis, or a significant deterioration in~     clinical status including dysfunction of two or more organ systems (defined by ACCP/SCCM~     Organ Failure Guidelines, Chest 2009). All patients will receive current standard management~     for severe acute pancreatitis and a standardized protocol for application of therapeutic~     hypothermia and rewarming. Our primary endpoints are organ-specific cardiovascular,~     respiratory, hematological, renal, and metabolic dysfunction as measured at 28 days. Logistic~     Organ Dysfunction Scores (LOD) will be compared before and after therapeutic hypothermia,~     establishing day 4 versus day 1 changes in LOD. Secondary endpoints include D-dimer, IL-6,~     C-reactive protein, APACHE II scores on day 1 and day 4, inpatient and ICU length-of-stay,~     infection, mortality, and hypothermia-associated side effects including cardiac arrhythmia,~     electrolyte imbalance, hyperglycemia, major bleeding, and acute pancreatitis. We believe that~     such a study will supply preliminary answers to our chief research questions: does~     therapeutic hypothermia reduce morbidity as assessed by organ-specific outcomes, does~     therapeutic hypothermia attenuate the steep rise in inflammation observed in severe acute~     pancreatitis, and does therapeutic hypothermia shorten the clinical course for these~     patients.~   "
135411|NCT01794845|"~     Whether low-dose radiation in addition to Taxotere and Erbitux improves the response rate of~     patients with recurrent unresectable head and neck squamous cell carcinoma.~   "
135412|NCT01794832|"~     Our main hypothesis on the present study is that new parameters such as risk-taking behavior,~     patients motivation, health related quality of life, new biomarkers and more precise~     echocardiography measures in addition to traditional parameters will improve pre-operative~     risk assessment in patients with AS and better guide patients and doctors in decision whether~     to operate or not.~   "
135413|NCT01794819|"~     The aim of this study is to evaluate the usefulness in Russian general practice of C-reactive~     protein testing in patients with acute cough or lower respiratory tract infections.~      In addition to studying the effect of C-reactive protein testing on the prescription of~     antibiotics, the purpose is to find out whether the frequency of referral to radiography~     could be reduced.~   "
135414|NCT01794806|"~     The purpose of this study is to clinically and radiographically assess whether the use of a~     ridge preservation technique significantly minimizes alveolar ridge resorption following~     tooth extraction.~   "
135415|NCT01794793|"~     The purpose of this study is to allow continued use of pasireotide in patients who are on~     pasireotide treatment in a Novartis-sponsored, Oncology Clinical Development & Medical~     Affairs (CD&MA) study and are benefiting from the treatment as judged by the investigator.~   "
135416|NCT01794780|"~     This multi-center study is designed to describe natural history of disease, treatment and~     health care products in physician-diagnosed COPD patients who require adding daily~     maintenance therapy in real world.~   "
135417|NCT01794767|"~     The aim of the study is to verify if the periodic flush with normal saline 0.9% NaCl causes a~     longer or equal duration of patency of peripheral venous catheters, compared with heparin~     solution 50 U / ml flush, in children from 2 years to 14 years. Only 22 and 24 gauge~     catheters Will be included in the study.The study will assess in particular:~        -  the difference of permanence in situ of the device~        -  the difference in incidence of complications (in detail: obstruction, phlebitis,~          thrombocytopenia, systemic anticoagulation)~        -  the difference in costs between use of saline normal saline 0.9% NaCl solution and~          heparinized 50 U / ml.~   "
135418|NCT01794754|"~     The purpose of the study is to investigate if occupational therapy may delay or prevent the~     need for surgery in patients with carpometacarpal(CMC) osteoarthritis (OA) who are scheduled~     for surgery in the CMC-joint.~      Our study hypothesis is that compared to participants in the intervention group,~     significantly more participants in the control group have received CMC-surgery after two~     years.~   "
135419|NCT01794741|"~     This is a 3 month safety study of Dymista Nasal spray in children aged 4 to 11 years with~     allergic rhinitis~   "
135420|NCT01794728|"~     The How the Elderly Live with Pain in Heart Failure (HELP-HF) study provides the opportunity~     to assess the complaints of pain in a cohort of HF patient admitted to Thomas Jefferson~     University Hospital (TJUH). Additional information on their existing co-morbid conditions, an~     inventory of their prescribed medications, and details regarding the type of treatment~     interventions (over the counter analgesia and other comfort practices) they report using will~     be collected.~   "
135421|NCT01794715|"~     Cross-over study aimed to study the diagnostic and clinical impact of routinely adding a~     pocket-size ultrasound examination to traditional care at a outpatient heart failure clinic.~   "
135422|NCT01794702|"~     The goal of Phase I of this clinical research study is find the highest tolerable dose of~     clofarabine that can be given with decitabine, idarubicin, and cytarabine to patients with~     acute leukemia.~      The goal of Phase II of this study is to learn if decitabine followed by the combination of~     clofarabine, idarubicin, and cytarabine can help to control acute leukemia. The safety of~     this drug combination will also be studied.~      Decitabine and idarubicin are designed to damage the DNA (the genetic material of cells).~     This may cause cancer cells to die.~      Clofarabine is designed to interfere with the growth and development of cancer cells.~      Cytarabine is designed to insert itself into DNA and stop the DNA from repairing itself.~   "
135423|NCT01794689|"~     Twenty percent of Americans suffer from chronic pain. Sleep disturbance is similarly~     prevalent and among the most common and disabling neurobehavioral problems associated with~     chronic pain. This research is designed to evaluate the effects of disrupted sleep patterns~     on mood, inflammation, the perception of pain, and pain relief. This study will help~     researchers understand the relationship between sleep and pain, and how sleep disturbance~     might influence chronic pain conditions.~   "
135424|NCT01794676|"~     This study is being conducted to identify altered genetic factors that may exist and~     influence endocrine cancers in unrelated MEN1 families with different cancers. A grading~     system will be developed for endocrine cancers, including pancreatic cancers, thymus gland~     cancers, parathyroid disease and MEN1 syndrome as low-risk and high-risk to improve screening~     and timing of surgery.~   "
135425|NCT01794663|"~     When a patient receives a kidney transplant particularly if the kidney is from an older donor~     or one who has had the kidney removed after their heart has stopped, there is a risk that the~     newly transplanted kidney may not function immediately. If the delay in function means that~     dialysis is needed in the first 7 days after the transplantation then this is known as~     delayed graft function or dDGF. Also delayed graft function that does not require dialysis~     but is present because the serum creatinine does not fall sufficiently is known as functional~     delayed graft function or fDGF. This problem is often due to an excessive inflammatory~     reaction to not having had a blood supply between the time of donation and transplant.~      OPN-305 is a monoclonal antibody that blocks Toll-like Receptor 2 which is thought to be~     partly responsible for increasing the risk of this inflammation. It is hoped that the effects~     of the inflammation will be reduced and therefore prevent dDGF and fDGF from occurring.~      The purpose of the study is to explore how effective OPN-305 is in preventing dDGF and fDGF~     as well as improving other measures of kidney function and the overall safety of the~     antibody. In the first part of the study, each patient received an Infusion of one of three~     possible doses of OPN-305 or a placebo and in the second part the most suitable dose of~     OPN-305 and a placebo would be used. The purpose of this second part of the study is to find~     out if a dose of OPN-305 which has already been tested in an earlier part of this study can~     prevent kidney graft dysfunction. For the purposes of this study, kidney function will be~     assessed using the composite of delayed graft function (dDGF) because dialysis is necessary~     in the first 7 days and functional delayed graft function that does not require dialysis but~     is present because the serum creatinine, a key measure of renal function, does not fall~     sufficiently (fDGF) in the first 7 days post-transplant.~      Protocol OPN305-103 follows out to 12 months post-transplant the clinical status and graft~     function of patients who have completed the 6-month post-transplant period under Part A or~     Part B of OPN305-102.~   "
135426|NCT01794650|"~     The investigators hypothesise that manipulating the glycaemic index of the meal after~     exercise and before sleep will help prevent Type 1 diabetes individuals experiencing~     hypoglycaemia.~   "
135427|NCT01794637|"~     End - stage liver disease can cause many problems to the patients including fatigue,~     weakness,jaundice, confusion, abdominal pain and distension. Another important problem is the~     cardiovascular system (heart and blood vessels). There will be the impairment of heart~     function to pump blood to the distal part of the body. Blood vessels are also affected by the~     imbalance of chemical agents which are not detoxified by diseased liver, resulting in~     impairment of oxygen carrying capacity and tissue oxygen exchange. Mechanism of this process~     is still poorly understood.~      This is a study about the peripheral vascular dysfunction by means of vascular occlusion test~     (VOT). Blood pressure cuff is inflated (to occlude the proximal vessels and induce distal~     part ischemia), then deflated and observing the distal tissue oxygenation (StO2)change by the~     probe (Near-infrared spectroscopy : NIRS) at the hand. From our knowledge, there is no study~     in patients undergoing liver transplantation.~      The study investigator would like to observe the change in peripheral tissue oxygenation in~     different time points during the liver transplantation. We hypothesize that there is a change~     in microcirculatory function and StO2 in end-stage liver disease patients detected by VOT and~     NIRS.~   "
135436|NCT01794520|"~     The phase 1 primary objectives of this study are to assess the safety profile, characterize~     pharmacokinetics (PK) and determine the dosing schedule, maximum tolerated dose (MTD), and~     recommended phase 2 dose (RPTD) of ABT-199 (venetoclax) when administered in subjects with~     relapsed or refractory multiple myeloma. This study will also assess the safety profile and~     PK of venetoclax in combination with dexamethasone in subjects with t(11;14)-positive~     multiple myeloma.~      The phase 2 primary objective is to further evaluate the objective response rate (ORR) and~     very good partial response or better rate (VGPR+) in subjects with t(11;14)-positive multiple~     myeloma and to evaluate patient reported outcomes.~   "
135428|NCT01794624|"~     TMD is a poorly understood chronic pain disorder that affects up to 15% of the adult~     population, notably impacting women, is linked to greater healthcare utilization, and~     associated with multiple pain-related co-morbidities. Pain-related catastrophizing (CAT) and~     sleep continuity disturbance (SCD) are well established modifiable risk factors for TMD and~     other idiopathic pain conditions. Neither the causal status nor the neurobiological~     mechanisms by which these factors exert their effects on clinical pain have been established.~     We propose that CAT and SCD influence clinical pain through shared alterations in pain~     modulation and key neurobiological pathways, including amplified inflammatory activity,~     autonomic activity, and adrenocortical functioning. Beyond these shared mechanisms, however,~     we propose to determine whether pre-sleep CAT increases cortical arousal during sleep. The~     cognitive dimensions of pre-sleep arousal, particularly rumination and negative sleep-related~     thoughts, are central to the phenomenology of insomnia. Extending this notion, we propose~     that CAT in those experiencing ongoing clinical pain fosters sleep disturbance owing to~     increased pre- and peri-sleep cognitive arousal. Moreover, we propose that pre-sleep CAT is~     related to subtle variations in objective indices of fragmented sleep (e.g., cortical~     arousal). We will examine key hypotheses derived from this framework using a brief,~     prospective randomized experiment, which will permit careful analysis of the temporal~     patterning of how changes in either CAT or SCD influence each other and contribute to~     alterations in pain modulatory systems, key nociceptive mechanisms, and clinical pain.~      Women experiencing at least moderate chronic TMD pain (N=225) who demonstrate at least mild~     trait catastrophizing and meet at least subclinical insomnia criteria (SCD) will be randomly~     assigned to: 1) cognitive therapy for catastrophizing (CT-CAT); 2) behavior therapy for sleep~     disturbance (BT-SCD); or 3) TMD education (Control). Assessments of clinical pain, sleep~     disturbance, catastrophizing, pain sensitivity and modulatory systems, and indices of~     inflammatory activity, adrenocortical function and autonomic balance will be completed at~     baseline, 4 weeks (mid-manipulation) and 8 weeks (post-manipulation). Clinical pain, sleep,~     catastrophizing and covariates will additionally be measured at 16 weeks (follow-up).~   "
135429|NCT01794611|"~     C-MAC videolaryngoscope (Karl Storz, Tuttlingen, GERMANY) with its Macintosh like blade is~     used with standard direct laryngoscopy technique. KingsVisionTM videolaryngoscopes~     (KingSystems, IN, USA) have also Macintosh like single use blades that are channeled, wider~     and shorter than conventional Macintosh blades.We aim to compare these two laryngoscopes and~     Macintosh laryngoscope during routine intubation in adult patients.~   "
135430|NCT01794598|"~     Purpose of the Study: The significant impact of depression on the poor prognosis and~     functional restrain, recognition and successful treatment of depression in patients with~     Chronic Heart Failure (CHF) may result in improvement of overall outcome of those patients.~     However, depression comorbid with CHF has been overlooked in the real practice. Therefore,~     the investigators are proposing a study to 1) assess the prognostic impact of depression in~     patients with stable CHF who have been managed as outpatients, and 2) assess whether~     provision of depression education to CHF patients will improve the care of depression.~      Patients with chronic heart failure are enrolled into this study with a half of them are~     randomly assigned to receive a packet of depression education materials and then other half~     not. Participants and investigators both are blinded to the assignment. All the participants~     are provided a toll free phone number to contact the research team as needed. Depressive~     symptoms and patients knowledge of depression are assessed at baseline prior to randomization~     and at 1-month and 6-month following the enrollment.~      Responses of the study participants, such as change of depressive symptoms, and requests for~     psychiatric help are examined between two groups.~   "
135431|NCT01794585|"~     The purpose of this study is to evaluate the effectivenes of a home-based physical therapy~     program designed to improve balance following traumatic brain injury by incorporating the use~     of a virtual reality system.~   "
135432|NCT01794572|"~     In Multiple Myeloma, an adult hematological malignancy, mainly located in the Bone Marrow~     (BM), dramatic recent progresses have been observed, thanks to new agents (proteasome~     inhibitors and IMIDs). However, at time of first relapse, high-dose therapy followed by Stem~     Cell Rescue (SCR) is frequently mandatory as a consolidation in minimal residual disease, to~     healthy patients under 65 yo, combining Melphalan (MPH) and/or Total Body Irradiation. Modern~     irradiation modalities are now available by the use of HI-ART Tomotherapy system to realize a~     Total Bone Marrow Irradiation (TBMI), in order both to limit the dose administered to Organ~     at Risk (lungs, oral cavity) and to focus efficacy on BM. In this phase-1 study, the~     conditioning regimen before SCR will combine a fixed high-dose MPH (140 mg/m²) and a dose~     escalated TBMI, so as to define its Maximal Tolerated Dose (MTD) and the Dose Limiting~     Toxicities (DLT). An extended cohort will further in a phase-2 setting.~   "
135433|NCT01794559|"~     This is a prospective, multicenter, randomized, double-blind, controlled study to evaluate~     the effectiveness of PEER Interactive to inform treatment in subjects with a primary~     diagnosis of depression with comorbidity of non-psychotic behavioral disorders versus~     treatment as usual, as determined by the investigator. The primary measurement for~     improvement of the subjects depression will be a self-evaluation questionnaire, Quick~     Inventory of Depressive Symptomatology-Self Report 16 , but the investigators will also~     collect information on their clinical global improvement and any reduction in adverse events.~   "
135434|NCT01794546|"~     Obesity is perhaps the most urgent public health crisis in pediatrics. Thus, managing~     childhood obesity is a top priority among pediatricians in primary care settings. However,~     effective treatment typically is multidisciplinary, and most practices currently do not have~     the infrastructure for coordinating integrated care. With the advent of the Affordable Care~     Act (ACA), innovative systems for building multidisciplinary teams to provide integrated care~     through a patient-centered medical home will be at a strategic advantage. The use of~     electronic technologies for delivering health-related information or services, known as~     telehealth, is an innovation with the potential to streamline integrated care and transform~     interventions for chronic diseases. We propose a pilot study to evaluate telehealth for~     treating pediatric obesity in collaboration with a community practice (Wareham Pediatrics).~      Patients aged 10 to 17 years who participate in the telehealth intervention study (N=40) will~     be randomly assigned to an immediate intervention group or a wait list control group.~     Subjects in the immediate intervention group will begin the 6-month telehealth intervention~     at the time of enrollment in the study and then receive general patient/family counseling~     from their primary care providers (PCPs) at routine office visits during a 6-month follow-up~     period. Those in the wait list control group will receive general patient/family counseling~     from their PCPs for 6 months followed by the telehealth intervention for 6 months. Thus, the~     total duration of participation in the study for each subject will be 12 months. The~     telehealth intervention will include dietary, physical activity, and behavioral management~     counseling provided by videoconferencing from the OWL clinical providers at Boston Children's~     Hospital to children in their homes, or at a telehealth station at Wareham Pediatrics.~   "
135435|NCT01794533|"~     Achievement of a deep and long-durated anesthesia is vital before most endodontic procedures;~     therefore, the investigators conducted this study to compare the local infiltration effect of~     epinephrine-containing lidocaine with/ without fentanyl on depth and duration of anesthesia~     in maxillary molars with painful irreversible pulpitis.~   "
135437|NCT01794507|"~     The primary objectives of this study are to assess the safety profile, characterize~     pharmacokinetics (PK) and determine the dosing schedule, maximum tolerated dose (MTD), and~     the recommended phase two dose (RPTD) of ABT-199 when administered in subjects with relapsed~     /refactory multiple myeloma who are receiving bortezomib and dexamethasone as their standard~     therapy.~   "
135438|NCT01794494|"~     Severe atherosclerosis in the leg arteries is termed critical limb ischemia (CLI). This~     condition gives great suffering for the patients in terms of pain, wounds and often~     developing gangrene. Untreated, the condition has a high risk of amputation. In Sweden, the~     majority of the patients are investigated and evaluated for treatment. Treatment is carried~     out either by traditional open bypass surgery or balloon dilatation technology (endovascular~     treatment). The latter method is still under development, and studies have shown that the~     treatment has less local and systemic complications than bypass surgery. It is also shown~     that the method has a limitation in that the treatment effect is less durable. What is the~     role of minimally invasive technologies should have in the future is unclear, mainly due to~     its efficiency and cost-effectiveness compared with bypass surgery are not evaluated. In a~     prospective observational study we intend study the effectiveness, cost-effectiveness and~     impact on quality of life in patients undergoing treatment for critical CLI with bypass~     surgery or endovascular treatment in Västra Götaland Region (VGR). All patients over a period~     of two years, which undergo treatment for CLI with either of the two methods will be included~     in the study. Patients will be followed up with regard to the clinical efficacy and life~     qualifying small after treatment at, respectively one, 12 and 24 months. Cumulative care~     costs are calculated and estimates of cost are made. This study aims to increase knowledge~     about the role of endovascular treatment of CLI shall have in the future.~   "
135439|NCT01794481|"~     The purpose of this study is to evaluate the potential benefit of an individualized~     resistance exercise-training program during radiotherapy for patients with locally advanced~     head and neck cancer.~   "
135440|NCT01794468|"~     Background: Conditions of reduced perfusion are characterized by redistribution of blood flow~     away from the skin to more vital organs.~      Study Objectives: To assess the efficacy of a non-invasive, dermal blood flow (DBF) monitor~     in detecting changes in perfusion in critically ill patients.~      Preliminary Study~      Study Population: critically ill patients in a general ICU~   "
135441|NCT01794455|"~     This pilot proposal will test the hypothesis that altered cerebral vessel reactivity and~     cerebral hypoperfusion (decreased blood flow to the brain) is a core mechanism underlying the~     relationship between vascular disease and depression in older adults. The long-term objective~     of this line of research is to: A) determine the relationship between vascular reactivity,~     cerebral hypoperfusion and the persistence of late-life depression and B) determine if~     improving cerebral perfusion with angiotensin receptor blockers (ARBs) improves depression~     outcomes.~   "
135442|NCT01794442|"~     Retinal ischemia is thought to play an important role in the pathogenesis of glaucoma. Recent~     findings have confirmed that there is a direct correlation between the levels of venous~     oxygen saturation and the degree of the glaucomatous disease, presumably due to a decrease in~     retinal cell metabolism.~      However, glaucoma patients have been suggested to have a different pattern in retinal venous~     circulation. For instance, the observation of a visible pulsating central retinal vein is a~     phenomenon that can be seen in up to 98% of the healthy individuals but is identifiable in~     less than 50% of glaucoma patients. While the nature of these venous changes are not year~     clear, the lack of a visible pulsating flow could suggest an increased intraluminal venous~     pressure due to some obstruction from both ocular or extraocular structures. This~     undetermined increase in venous pulse pressure could then significantly decrease perfusion~     pressures and therefore further decrease oxygen supply to the retinal tissues.~      The investigators will therefore try to determine if there is a significant difference~     between the oxygen saturation of the retinal vessels in both glaucoma patients with and~     without a visible pulsating central vein~   "
135443|NCT01794429|"~     To examine if 3 months of treatment with a GLP-1 (glucagon-like-peptide-1) analogue can~     induce weight loss in obese, non-diabetic patients with a diagnosis within the schizophrenic~     spectrum.~      The investigators will also examine possible associations between GLP-1 treatment and~     peripheral metabolic parameters such as change in body fat and HbA1c. Moreover, the GLP-1~     analogue treatment will be associated with the effects/changes on cognition and subjective~     quality of life. Possible cerebral effects (pro-cognitive) of the GLP-1 analogue treatment~     will associated and correlated with changes in the brain, functional magnetic resonance~     imaging (fMRI).~   "
135444|NCT01794416|"~     The investigators aimed to compare two approaches thoracoscopic epicardial ablation and~     endocardial catheter ablation after failed initial catheter ablation in patients with~     paroxysmal atrial fibrillation.~   "
135445|NCT01794403|"~     Accelerated Hypofractionation Radiotherapy for prostate cancer of 36.25 Gy delivered in 5~     fractions will not be inferior to the standard treatment of 70.2 Gy given in 26 fractions~     with respect to two-year failure defined as a positive biopsy two years post treatment~     completion or earlier evidence of biochemical or clinical failure.~   "
135446|NCT01794390|"~     Randomised, cross sectional, observational study evaluating inhaler device critical errors~     (errors that could affect dose delivery to the lungs) for the Pulmojet inhaler compared to~     Diskus or Turbuhaler in asthma and COPD patients receiving regular maintenance inhaled~     steroid therapy.~   "
135447|NCT01794377|"~     The purpose of this study is to evaluate the efficacy of 2 physical exercise training~     programs, with a supplementation in fruits and vegetables, on energy cost of walking. 60~     subjects will be randomized into 2 groups. The first program will be consist of an interval~     strength training for 30 min on bicycle ergometer (which include strengthening exercises in~     an high intensity interval training). The second program will be conducted at a relatively~     low intensity of effort, corresponding to 50% of oxygen uptake (VO2) peak measured by~     indirect calorimetry. All subjects will receive a free supplement of 5 fruits and vegetables~     per day during all the intervention. The intervention will last 9 months in total : 5 month~     at the hospital fallow by 4 month at home.~   "
135448|NCT01794364|"~     The primary purpose of this trial is to evaluate the safety and tolerability,~     pharmacokinetics, and pharmacodynamics of single oral doses of PF-06291874 in healthy~     volunteers.~   "
135449|NCT01794351|"~     This study investigated the potentially cognitive enhancing effects of 500mg~     trans-resveratrol in healthy, young humans.~   "
135463|NCT01794169|"~     The purpose of this study is to determine whether Azacitidine consolidation is superior to~     standard DA consolidation treatment of acute myeloid leukemia in first complete remission in~     elderly patients.~   "
135450|NCT01794338|"~     This study evaluates the outcomes of patients who have been treated with Strattice or Gore~     Bio-A mesh for the repair of complicated abdominal wall hernias. The purpose of this study is~     to collect information and evaluate the outcome of your surgery. Synthetic (man made) mesh~     has been shown to provide durable long-term outcomes; however, this type of mesh should not~     be used in patients at risk of developing an infection. Therefore, to address the challenge~     of finding an artificial strengthening material to repair complicated hernias in patients~     that could potentially develop surgical infection, two types of non-permanent materials have~     been developed, including biologics and bioabsorbables. Biologic mesh is made of living~     tissue and bioabsorbable mesh is made of synthetic material that is gradually absorbed by the~     body over time. The purpose of this study is to allow surgeons to compare the postoperative~     course of patients associated with these two mesh types to decide which material will improve~     the outcomes of their patients with complicated abdominal wall defects. To date there is no~     evidence to suggest that either mesh type is superior or safer than the other.~   "
135451|NCT01794325|"~     Transradial approach (TRA) reduces vascular complications and access related-bleeding~     compared to transfemoral approach (TFA). However, this technique has been related to higher~     radiation exposure during coronary angiography and percutaneous coronary intervention.~     Previous studies have shown that TRA demands a long learning curve, and procedure success~     rate increases with operator's experience. Our hypothesis is that the higher radiation~     exposure during TRA is not a technique issue, but due to operator's expertise.~      The aim of this study is to evaluate whether experienced operators with either TRA or TFA can~     perform diagnostic coronary angiography with similar radiation exposure.~   "
135452|NCT01794312|"~     The purpose of this study is to assess the efficacy and safety of T4020 versus vehicle.~   "
135453|NCT01794299|"~     The purpose of this study is to determine whether ATIR is safe and effective in reducing~     transplant-related mortality and improving overall survival, when infused in patients with a~     hematologic malignancy following a T-cell depleted stem cell graft from a related~     haploidentical donor.~   "
135454|NCT01794286|"~     Specific Aim: To improve childhood immunization rates by utilizing automated Electronic~     Health Record-derived provider-specific performance feedback reports, coupled with automated~     Electronic Health Record-derived trigger alerts.~      Hypothesis: The automated Electronic Health Record-derived provider-specific performance~     feedback reports will result in a 50% decrease in unimmunized children ages 0-13 years of~     age, when coupled with automated Electronic Health Record-derived trigger alerts, compared~     with trigger alerts alone.~   "
135455|NCT01794273|"~     The effects on brain perfusion of the two currently vasopressors used to treat accidental~     hypotension occurring during carotid surgery (i.e. ephedrine and phenylephrine) is not known,~     but a disadvantage to use phenylephrine is suspected, due to its mechanism of action and~     according to published reports~   "
135456|NCT01794260|"~     The objectives of this study are to assess short term efficacy and safety of of topical~     preparation of essential oil extracted from ZINGIBER CASSUMUNAR ROXB in patients suffering~     from osteoarthritic pain~   "
135457|NCT01794247|"~     5% hyperbaric lidocaine has lost its usefulness for same-day-surgery (SDS) anaesthesia~     because it has been blamed responsible for the so-called transitory neurological syndrome~     (TNS). This entity appears particularly in patients operated on lithotomy and knee~     arthroscopy position and obese patients. It is a benign, moderately painful (grade 3-4 out of~     10) and self-limited in time, but disturbing enough to be avoided in same-day-surgery cases.~     Other local anesthetics are not competitive with general anesthesia in time to be discharged~     home from the SDS unit. The magnesium ion is well-known for its protective properties on~     cells with electrical activity. The objective is to confirm that the magnesium ion added as~     adjuvant to intrathecal (IT) lidocaine may antagonize TNS incidence. If this hypothesis could~     be confirmed, the practical and theoretical consequences would be far-reaching.~      The method to achieve our objective would be a double-blinded randomized clinical trial~     considering two groups of intrathecal lidocaine: with and without added IT magnesium.~   "
135458|NCT01794234|"~     This observational study will evaluate the efficacy and safety of Pegasys (peginterferon~     alfa-2a) in patients with chronic hepatitis B who have failed antiviral treatment with~     nucleoside (nucleotide) analogues. Data will be collected from patients treated according to~     the current Summary of Product Characteristics and local standard of care and regulations~     during 48 weeks of treatment and 24 weeks of follow-up.~   "
135459|NCT01794221|"~     The objective of this study is to evaluate whether 2-octyl cyanoacrylate skin adhesive~     decreased the incidence of recurrent adhesions after circumcision. The investigators~     hypothesize that the incidence of recurrent adhesions will be decreased with use of 2-octyl~     cyanoacrylate skin adhesive.~   "
135460|NCT01794208|"~     The aim of the current study is the determination of the recommended standard treatment dose~     of FSH-GEX(TM) in women undergoing ICSI (intracytoplasmic sperm injection) treatment as~     assessed by follicle growth.~   "
135461|NCT01794195|"~     Use lay language.~      Apathy is one of the most under recognised, underdiagnosed and poorly managed aspects of~     Parkinson's disease. Depending on methodological approach of the study, its prevalence is~     estimated to be between 16 and 51%.~      Apathy derives from a dysfunction of the dopaminergic meso cortico limbic systems, which~     seems to play a central role in the control of mood and motivation. The subcortical~     components of this system are the ventral tegmental area (VTA), the nucleus accumbens, and~     the constituents of the limbic system (particularly the hippocampus and amygdala), all of~     which are located deep inside the brain (18). The hypothesis is that depletion of striatal~     dopamine from regulators located in the midbrain (VTA and SNpc) in striato-thalamo-cortical~     circuits results in hypofunction of these circuits and the loss of frontal cortical activity,~     particularly within in the frontal orbital cortex, the anterior cingulate cortex and the~     prefrontal cortex~      The objective of this study is to explore, using diffusion weighted MRI, the regions of the~     brain which are proposed to play a role in motivation in apathetic Parkinson's disease~     patients and to define more precisely the relation between dopaminergic fibres and the~     meso-cortico-limbic system with the help of tractography methods~   "
135490|NCT01793818|"~     Tat Oyi vaccination on seropositive patients could help their immune system to recognize and~     neutralize Tat. The neutralization of extra cellular Tat should help the cellular immune~     response to eliminate HIV-1 infected cells.~   "
135464|NCT01794156|"~     Obsessional compulsive disorder (OCD) is a very debilitating psychiatric problem which~     affects around one million Canadians and their families. Obsessions are intense~     preoccupations about bad, harmful, dangerous, shocking or unlucky events which 'may' occur~     and which drive sufferers to perform time consuming and distressing compulsive rituals to~     prevent the possible event occurring. The current psychological treatment of choice is~     cognitive behavior (CBT) therapy which focuses on treating OCD by reducing obsessional~     anxiety about the likelihood and the consequences of the preoccupying event. A rival~     cognitive model termed the inference-based therapy (IBT), developed by the principal~     investigator and co-workers, considers that the OCD begins with the initial doubting~     inference 'maybe something is wrong' and focuses on changing the reasoning behind this~     doubting inference which often trumps the common sense conviction that there is no reason to~     doubt. This clinical trial randomly allocates participants to either IBT or CBT treatment~     condition or to a third generic mindfulness condition. The latter condition is a non-specific~     meditational-based training which has shown evidence of reducing stress and anxiety across a~     number of psychiatric problems including OCD. Two hundred and forty people will be recruited~     over a 5-year period from two principal sites (Montreal and Gatineau/Ottawa) with which the~     principal investigator and co-investigators have clinical links. Therapy will be administered~     by trained professionals following a treatment manual specific to each approach. The therapy~     will last a maximum of six months or until the point when the person achieves a non-clinical~     status. The patients will be assessed pre, post, and at six months following treatment on~     standard evaluation instruments as well as on subjective measures. We expect the IBT to be~     superior in terms of number of participants responding to treatment, rapidity of improvement~     and gains at follow-up.~   "
135465|NCT01794143|"~     The GRADE Study is a pragmatic, unmasked clinical trial that will compare commonly used~     diabetes medications, when combined with metformin, on glycemia-lowering effectiveness and~     patient-centered outcomes.~   "
135466|NCT01794130|"~     The aim of this investigation is to determine the incidence of silent interstitial pulmonary~     edema by chest ultrasound at moderate altitude (3905m). Secondary endpoints are to detect a~     suspected association with acute mountain sickness (AMS), co-morbidities and endothelial~     dysfunction (marker of hypoxia responses, endothelial damage and inflammation).~   "
135467|NCT01794117|"~     Background:~        -  Inflammatory pustular skin diseases are a type of autoinflammatory disease in which the~          immune system attacks the body s tissues. These diseases cause painful and itchy skin~          rashes, eye and mouth irritation, joint pain and fever. Several drugs for treating these~          diseases suppress the immune system. However, they can cause severe side effects when~          taken over a long period of time.~        -  IL-1 is a small protein that may be important in causing the inflammation seen in~          pustular skin disease. Anakinra is a drug that works by blocking IL-1. It has been~          effective in treating some inflammatory conditions such as rheumatoid arthritis.~          However, anakinra has not been studied for use in patients with pustular skin disease.~          Researchers want to see whether anakinra will be effective in treating pustular skin~          disease.~      Objectives:~      - To see if anakinra can be used to treat inflammatory pustular skin disease.~      Eligibility:~      - Individuals at least 18 years of age who have inflammatory pustular skin disease.~      Design:~        -  Participants will be screened with a physical exam and medical history. Their disease~          will be evaluated with blood tests, urine tests and imaging studies. Skin biopsies may~          also be collected.~        -  Participants will have an initial visit to receive the first dose of anakinra. They will~          be shown how to give themselves daily injections of anakinra.~        -  Participants will take anakinra for up to 12 weeks as long as there are no severe side~          effects. During this time, they will keep a study diary to record the severity of any~          rashes, pustules, itching, fevers, and skin or joint pain. They will bring this diary to~          their study visits.~        -  Participants will have study visits at weeks 4, 8 and 12. Treatment will be monitored at~          these visits with blood tests, urine tests and physical exams. Depending on the effects~          of the treatment, participants may have the dose of anakinra increased or decreased.~        -  Participants will have a final study visit 4 weeks after they stop taking anakinra.~   "
135468|NCT01794104|"~     Background:~      - Indenoisoquinoline LMP400 is an experimental cancer treatment drug. It damages DNA in tumor~     cells. Tumor cells with damaged DNA may die, resulting in cell death. Researchers want to see~     if this drug is a safe and effective treatment for solid tumors and lymphomas that have not~     responded to earlier treatment.~      Objectives:~      - To see if Indenoisoquinoline LMP400 is a safe and effective treatment for advanced solid~     tumors or lymphomas.~      Eligibility:~      - Individuals at least 18 years of age who have solid tumors or lymphomas that have not~     responded to treatment.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Tumor samples may also be collected. The size and location of~          the tumors will be determined with imaging studies.~        -  Indenoisoquinoline LMP400 is given in a 28-day cycle. Participants will receive the drug~          by intravenous infusion on days 1, 8, and 15 of each cycle, followed by a break of 13~          days without the drug.~        -  Treatment will be monitored with frequent blood tests and imaging studies. Tumor samples~          will be optional.~        -  Participants will continue their cycles of treatment as long as the cancer does not grow~          and there are no severe side effects.~   "
135469|NCT01794091|"~     People with diabetes are at an increased risk of heart attacks and heart failure, and it is~     important to be able to treat people with diabetes who are at risk for heart disease to~     prevent these outcomes. This study is looking at the importance of diffuse scar tissue that~     is found in the heart of diabetic people. We have discovered a way to detect diffuse scar~     tissue by cardiac MRI, a non-invasive test. In this study, we do cardiac MRI on diabetics~     with low risk stress test results and follow them for 5 years to see if the measure of scar~     tissue in the heart by MRI is related to events. If this study is positive, we will be able~     to use cardiac MRI scar tissue measurements to target those patients with diabetes who are at~     highest risk.~   "
135470|NCT01794078|"~     Acute exposure of the unacclimatized human body to high altitude leads to health~     complications, such as loss of exercise performance capacity and fatigue. The investigators~     have found that the combination of the xanthine drug theophylline and the endothelin receptor~     antagonist ambrisentan improves the exercise performance capacity of rats under simulated~     high altitude. In young, healthy human volunteers, this combination of drugs has not increase~     toxicity over the single compounds under sea-level conditions. The aim of this study is to~     test whether the combination of theophylline, supplied as its more soluble formulation~     aminophylline, and ambrisentan, are also safe to take under simulated high altitude of 4,267~     meters, under both resting and exercising conditions. The study also aims to test whether~     this drug combination improves exercise capacity in humans. In this study, human subjects~     will be randomized to one of four treatment sequences and receive the same study drug(s)~     throughout all procedures. The study consists of an initial exercise test, followed by two~     cycles of drug testing at simulated high altitude: Cycle 1 - resting subjects receiving study~     drug at simulated altitude and continually monitored for safety with pharmacodynamic and~     pharmacokinetic assessments; and Cycle 2, the same as Cycle 1, with the addition of exercise~     testing. It is hypothesized that the combination of aminophylline and ambrisentan is not only~     safe under simulated high altitude, but also improves exercise performance capacity, in~     comparison with placebo.~   "
135471|NCT01794065|"~     This study is being done to study stent deformation on persons with de novo coronary lesions~     to determine how much deformation takes place and how often. The information gathered from~     the group that receives the Promus element stent will be compared to other groups that~     receive other contemporary drug eluting stents.~   "
135472|NCT01794052|"~     Hypertension and diabetes are major risk factors for cardiovascular diseases. Although these~     two conditions can be detected much early in life and are amenable to interventions at~     primary health care level, the health system in India fails to provide adequate interventions~     at primary health care level which translates to huge burden of undiagnosed and uncontrolled~     hypertension and diabetes in the community. This study aims to design a feasible and~     sustainable evidence-based, decision support-enabled, health care delivery model for the~     management of hypertension and diabetes in the primary health care facilities of Himachal~     Pradesh. The study will be conducted at the 5 Community Health Centers (CHCs) and District~     Hospital of Solan District, Himachal Pradesh using both qualitative and quantitative methods.~     The design and development of the model will be carried out in the initial six months~     followed by piloting the services at the CHCs and District Hospital. The impact of the model~     on quality of care will be assessed in a pre-post design measuring changes in both clinical~     and process indicators.~   "
135473|NCT01794039|"~     This randomized phase II trial studies how well pomalidomide and dexamethasone work compared~     to lenalidomide and dexamethasone in treating patients with multiple myeloma that has~     returned after a period of improvement (relapsed) or did not respond to previous treatment~     with lenalidomide (refractory). Pomalidomide and lenalidomide may help the immune system kill~     cancer cells and may also prevent the growth of new blood vessels that tumors need to grow.~     Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth~     of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping~     them from spreading. Dexamethasone may also help pomalidomide and lenalidomide work better by~     making cancer cells more sensitive to the drugs. It is not yet known whether pomalidomide and~     dexamethasone or lenalidomide and dexamethasone are effective in treating patients with~     relapsed or refractory multiple myeloma.~   "
135474|NCT01794026|"~     Preoperative staging for gastric adenocarcinoma is an important procedure to detect advanced~     disease stateS for the patients in which the surgery may be unnecessary to perform. Although~     there are many imaging techniques for this purpose, sensitivity and specificity of these~     techniques still remains to be low.Preoperative detection of peritoneal carcinomatosis and~     involvement of lymph nodes beyond D2 may prevent surgical procedures.~      Removal of the determined lymph nodes according to the type of the surgery is the accepted~     surgical method. However, accurate determination of malignant lymph nodes may prevent~     dissection of some groups of the lymph nodes. These findings may cause a new definition of~     gastric lymph node dissection.~   "
135475|NCT01794013|"~     The objective of this study is to test whether adding the parent training program using the~     relationship-based approach could help the children with development disabilities (DDs) would~     confer additional benefits over routine clinical care available to both groups in terms of~     improving their development and reducing behavior problems.~   "
135476|NCT01794000|"~     The main purpose of the study is to evaluate the efficacy and safety of the study drug known~     as prasugrel for the reduction of Vaso-Occlusive Crisis events in pediatric participants with~     sickle cell disease. The study will also investigate reduction in daily pain in children who~     have sickle cell disease.~   "
135477|NCT01793987|"~     Chronic Rhinosinusitis (CRS) refers to a pathological condition where the sinonasal mucosa is~     inflamed for greater than 12 weeks(1). It is associated with a constellation of symptoms,~     including facial pain, anosmia, and nasal congestion. It has been estimated that CRS affects~     close to 5% of the Canadian population(2). When medical therapy fails, patients are often~     referred to Otolaryngology- Head and Neck Surgeons for consideration of surgical management.~     Endoscopic sinus surgery (ESS) is one of the mainstays of therapy for CRS that has failed~     medical management(3). Traditionally, the microdebrider has been the go-to tool for~     performing these surgeries, but recently the Coblator (ArthroCare, Austin, Texas) has begun~     to define its' role in surgery. By using bipolar radiofrequency energy to ablate tissue (with~     temperatures up to 60˚ C)(4), theoretically the Coblator will result in less bleeding than~     so-called cold surgical techniques (i.e. the microdebrider). In a retrospective study by~     Eloy et. al, patients with CRS and nasal polyposis had a statistically significant amount of~     less intraoperative blood loss when the Coblator was used in their surgery, than those~     patients who underwent surgery with the microdebrider. The investigators plan to further~     investigate this in a randomized, controlled fashion~   "
135478|NCT01793974|"~     This is a prospective study that will study adults and has the objective of examining 'Latent~     Autoimmune Diabetes in Adults' (LADA) to understand how this trait is influenced by genetic~     factors.~   "
135479|NCT01793961|"~     Rates of driving under the influence of cannabis have risen in recent years. Cannabis is~     involved in 1/3 of motor vehicle collisions. The chronic use of cannabis is known to affect~     dopaminergic regulation and may thus impair contrast sensitivity. In turn, contrast~     sensitivity disorders could originate difficulties to anticipate and avoid collision with~     objects, especially when objects are in movement. The investigators goal is to examine the~     effects of a chronic intake of cannabis on contrast sensitivity. The observed values will be~     compared to standard references. In addition, since smoking cannabis is always associated~     with tobacco, the investigators will control the effects of tobacco on contrast sensitivity.~      In this study, the investigators will include 36 cannabis addicts, 36 tobacco addicts and 36~     no smokers. The investigators will present gratings with different spatial frequencies and~     the investigators will determine contrast thresholds for static and dynamic (moving)~     gratings. The investigators predict that cannabis addicts will present abnormal contrast~     sensitivity especially in case of dynamic presentation of gradings.~   "
135480|NCT01793948|"~     This randomized clinical trial studies metformin hydrochloride in overweight or obese~     patients at elevated risk for breast cancer. Metformin hydrochloride may decrease the~     expression of early tumor makers in breast tissue of patients at increased risk for breast~     cancer~   "
135491|NCT01793805|"~     This is a study to collect and analyze tissue specimens from metastatic colorectal cancer~     (mCRC) patients for the development of a molecularly profiled tissue repository for the~     primary purpose of maintaining a patient registry for future clinical trials based on the~     molecular profile of the tumors. The main purpose of testing these tissue specimens is to~     identify genetic alterations or biomarkers associated with colorectal cancer such that if new~     agent(s) become available, particularly those that target these genetic~     alterations/biomarkers, participants may be offered the opportunity to take part in a~     National Surgical Adjuvant Breast and Bowel Project (NSABP) treatment protocol.~   "
135481|NCT01793935|"~     Withania somnifera (WSE; Ashwagandha in Ayurveda) extracts have been used as an adaptogen or~     to build resistance to stress or diseases in indigenous medical systems in India for~     centuries. Modern scientific data for WSE indicate several bioactive molecules (withanolides,~     withanosides, indosides, withaferin-A, others) with significant immunomodulatory,~     anti-inflammatory and stress reducing properties.~      This study will examine whether a standardized extract of Withania Somnifera (WSE; Sensoril®)~     will improve total, positive, negative symptoms, and stress in patients with schizophrenia.~     The study will examine whether WSE reduces PANSS positive and negative symptoms and stress~     scores in subjects, and whether these improvements are mediated by changes in inflammatory~     immune indices. An additional aim will determine if patients receiving WSE will have fewer~     adjustments to their psychotropic medications that those assigned to placebo. The study will~     examine whether WSE will re-balance Th1/Th2 ratios (cytokine measures) and mediate a~     reduction of elevated hs-CRP levels. It is hypothesized that those subjects whose Th1/Th2~     ratios normalize will likely have a greater magnitude of clinical improvement versus those~     subjects whose immune ratios remain unbalanced.~      The proposal is a 12-week, double-blind, placebo-controlled RCT of WSE added to antipsychotic~     medications in approximately 60 or more patients with schizophrenia with an exacerbation of~     symptoms. If efficacy is affirmed, this low cost extract could be studied further, and used~     quite readily across low, middle and high income countries.~   "
135482|NCT01793922|"~     The aim of the study is to compare the efficacy of per-oral endoscopic myotomy (POEM) to the~     efficacy of pneumodilation as the initial treatment of symptomatic idiopathic achalasia. It~     is hypothesized that POEM has a higher long-term efficacy than pneumodilation in treatment of~     therapy-naive patients with idiopathic achalasia.~   "
135483|NCT01793909|"~     This study plans to learn more about the effects of type 2 diabetes (T2DM) on exercise blood~     flow and muscle oxygen uptake. This study will evaluate & compare exercise function during~     single leg plantar flexion exercise in a total of 45 subjects from the Denver area (15 lean~     controls, 15 people with T2DM, and 15 overweight control subjects).~      Differences between the exercise responses in people with T2DM and healthy people will help~     further identify the disease process of T2DM and direct future research of treatments and~     interventions.~   "
135484|NCT01793896|"~     Both dietary caloric restriction (CR) and physical exercise (PE) exert beneficial effects,~     which retard or prevent age-related diseases and prolong life span. Subjects with the~     metabolic syndrome age prematurely, therefore preventive measures should be initiated early.~     The present study intends to demonstrate that physical exercise and/or Mediterranean diet, in~     middle aged volunteers with the metabolic syndrome, preserve adequate adipose tissue~     functionality and retard skeletal muscle aging (assessed by mitochondrial biogenesis and~     accumulation of ROS), by activating several pathways, homologous to CR. The investigators~     plan to study this by using two approaches: 1) A cross- sectional model, in which the~     expression of the mentioned metabolic mediators, indicators of muscle mitochondrial~     biogenesis and muscle oxidative damage will be compared between men with different body~     compositions, fat distribution, muscle strength and exercise capacity (VO2max). Also, in~     these men the investigators will assess the expression of uncoupling protein 1 (UCP1) in~     subcutaneous white adipose tissue (as a measure of adaptive thermogenesis), and inflammatory~     markers (Interleukin 1-6, Interleukin 1ß and CCL2 chemokine (C-C motif ligand 2)) in~     preperitoneal adipose tissue, plus inflammation and adipogenesis potential of their cultured~     preadipocytes. Moreover, in vitro studies will evaluate the functional effects of exposure of~     a cell lyne of human adipocyte cells (LS14)to factors secreted by media conditioned by the~     patients´ adipose tissue explants. 2) A prospective intervention in overweight/moderately~     obese middle aged volunteers that will be assigned to a weight-maintenance period (as a~     control group), and then randomly y assigned to a Mediterranean diet, exercise training or~     diet plus training. Before and after 3 months of intervention the investigators will obtain~     muscle tissue samples to study the expression of Peroxisome proliferator activated receptor~     (PPAR) gamma coactivator 1 alpha (PGC1), uncoupling protein 3 (UCP3), AMP activated protein~     kinase (AMPK), Sirtuin 1 (SIRT-1), mitochondrial DNA and oxidative damage indicators~     (8-oxo-7,8-dihydro-2-deoxyguanosine (oxodG), carboxymethyllysine (CML and its receptor~     (RAGE)). In vitro studies will evaluate the effect of circulating factors from the patients~     (serum) on LS14 inflammatory and adipogenic potential, at baseline and after 3 months of~     intervention.~   "
135485|NCT01793883|"~     This Phase 2 protocol is designed to compare two dose levels of laninamivir octanoate versus~     placebo. The objectives are to obtain safety and efficacy in adults aged 18 to 64 years who~     present to clinic with symptomatic presumptive influenza A or B infection.~   "
135486|NCT01793870|"~     This will be a randomized, open-label, single dose, 4-period, period balanced, crossover~     study. There will be at least 5 days between dosing in each session. The study consists of~     Screening period (30 days prior to Day 1), Treatment period consisting of 4 dosing periods~     (Day 1 is the dosing day and Day 2) and Follow-up period (7-14 days post-last dose).~      The detailed treatment regimen will be A and B (27.5 mg total maximum dose): Single oral dose~     of carvedilol 25 mg immediate release tablet and up to 2.5 mg of enriched carvedilol powder~     under fasted conditions; C (33.75 mg total maximum dose): Single oral dose of carvedilol~     31.25 mg as 25 mg immediate release tablet, a 6.25 mg immediate release tablet and up to 2.5~     mg of enriched carvedilol powder under fasted conditions; D (27.5 mg total maximum dose):~     Single oral dose of carvedilol 25 mg immediate release tablet and up to 2.5 mg of enriched~     carvedilol powder under fed conditions. Approximately 15 subjects will be randomized to~     receive one of four treatment sequences (ADBC, BACD, CBDA, or DCAB).~      The pharmacokinetic sampling and safety data will be collected in the Treatment period (Day 1~     and 2).~   "
135487|NCT01793857|"~     The study is a survey aiming to describe the healthcare seeking behaviour of primary~     caregivers when their child aged 6 months to less than 30 months was suspected to have an~     episode of acute otitis media in Panama.~   "
135488|NCT01793844|"~     This is a prospective , open, multicenter, randomized phase Ⅲ study. The investigators planed~     to include 732 untreated CD20 positive diffused large B cell lymphoma adults,to random to~     R-CHOP21, CHOP14 , R-CHOP14 regimen groups after signature the informed consents. The~     patients will receive safety assessment every cycles, and efficacy evaluation every 2 cycles.~     Every-two-months follow up will be received after finishing the treatment.~   "
135489|NCT01793831|"~     The gut microbiota is considered to constitute a microbial organ which has pivotal roles in~     the intestinal diseases and body's metabolism. Evidence from animal and human studies~     strongly supports the link between intestinal bacteria and inflammatory bowel diseases (IBD).~     Dozens of studies reported its efficacy in treatment of severe Clostridium difficile colitis.~     Preliminary studies using FMT for Ulcerative Colitis (UC), Crohn's diseases (CD), irritable~     bowel syndrome (IBS) and constipation have also met with some success. However, the results~     on CD is very limited. This is an initial step into investigating the potential efficacy of~     fecal bacteriotherapy for CD, the investigators propose to determine the efficiency,~     durability and safety of FMT in a series of 500 patients with CD in ten years.~   "
135493|NCT01793779|"~     Study Objectives~        1. Compare beta-hydroxy-beta-methylbutyrate free acid (HMB-FA) to cold water immersion on~          performance recovery from an acute bout of high intensity resistance exercise.~        2. Compare HMB-FA + Cold water immersion to HMB-FA or cold water immersion.~        3. Examine the effect of these recovery modalities on markers of muscle damage,~          inflammation and immune function.~      Subjects~      Subjects (men and women, 18 - 35 y) with at least one year of resistance training experience~     will be recruited. Subjects will be randomly divided into one of four groups: a cold water~     immersion group (CW), HMB-FA, CW+HMB-FA and a control group (CT).~      Study Protocol~      Subjects will report to the Human Performance Laboratory (HPL) on four separate occasions. On~     the first visit (T1) subjects will be tested for maximal strength [one repetition-maximum~     (1-RM)] on the squat, dead lift and barbell lunge exercises.] On their second visit (T2)~     subjects will perform a lower body resistance exercise session consisting of four sets of the~     squat, dead lift and barbell lunge exercises. All subjects will then report back to the HPL~     at 24- (T3) and 48-hours (T4) post-exercise. During T3 and T4, subjects will perform four~     sets of the squat exercise only using the same loading pattern and rest interval length as~     T2. Following the T2 and T3 workouts subjects in CT will undergo no treatment; subjects in CW~     will be required to sit in a whirlpool tub for 10-min up to their umbilicus in water at 50° F~     - 54° F (10° C - 12° C); subjects in HMB-FA will be provided the supplement 30 min prior each~     workout and CW+HMB-FA will be administered together at time points describe above.~      Statistical Analysis~      Statistical evaluation of performance and biochemical changes will be accomplished using a~     repeated measures analysis of variance (ANOVA).~   "
135494|NCT01793766|"~     This is a study of overweight men and women. Everybody will receive a very low calorie diet~     to eat in place of meals for 10 weeks. During the last two weeks of the diet, half of the~     patients will receive an intervention to activate parts of their brain that can help them eat~     less. The other half of the patient will receive a placebo or sham intervention. The~     intervention will involve a small electric current given every day for 10 days. Everybody~     will be monitored for 16 more weeks (total of 26 weeks) while on a weight maintenance diet to~     see if the intervention helps people keep the weight off.~   "
135495|NCT01793753|"~     Background and Aim: An anorectal manometry (ARM) is a common test in the evaluation of outlet~     obstruction in constipation. In children under 6 yo, anesthesia is often used for patient~     comfort and compliance. The choice of anesthesia for ARM varies from center to center and~     includes the use of ketamine, inhalation agents, and propofol. With the increased use of~     propofol, our aim is to determine the effects of propofol on resting anal sphincter pressure~     while performing an ARM under general anesthesia.~      Hypothesis: Propofol administration leads to a decrease in internal anal sphincter pressure.~      Methods: This is a prospective, single center, observational study of the effect of propofol~     on the internal anal sphincter pressure. Pediatric patients between the ages of 2-6 years who~     require an anorectal manometry for chronic constipation will be offered enrollment.~     Anesthesia was required for patient compliance and comfort and conducted by an~     anesthesiologist. Sevoflurane was the inhalational agent used for induction. At Massachusetts~     General Hospital (MGH), 1 mg/kg of propofol bolus is routinely given at completion of the ARM~     test to reduce emergence delirium. The manometric probe was kept in place with continuous~     measurement of baseline internal anal sphincter pressure while propofol was administered. We~     measured changes to internal anal sphincter pressure and time to return to baseline.~      Results: The primary outcomes will be change of internal anal sphincter pressure from~     baseline and time to return to baseline.~      Discussion: The proposed investigation may demonstrate that propofol has an effect on the~     internal anal sphincter pressure which may affect its utility as an anesthetic for anorectal~     manometry.~   "
135496|NCT01793740|"~     The majority of school-age children with sickle cell disease (SCD) experience neurocognitive~     deficits, even in the absence of stroke. In particular, deficits in attention and working~     memory have emerged as two of the most common neurocognitive sequelae of SCD. Thus, the goal~     of the present proposal is to address feasibility and compliance of a novel computerized~     cognitive training program, Cogmed. Pilot data will also be collected to establish~     preliminary efficacy. Twenty-four children meeting initial age and diagnostic criteria will~     be identified and approached about participation by their attending physician during~     regularly-scheduled SCD clinic visits. Baseline assessments will include a brief measure of~     intellectual functioning, a brief cognitive testing battery evaluating processing speed and~     working memory, in addition to questionnaires regarding behavior and quality of life.~     Children will then be randomized to the computerized CT program Cogmed (n=12) or a waitlist~     control (n=12). Participants enrolled in the computerized CT program will be asked to~     complete 25-sessions of Cogmed over a five to eight week period (3 to 5 sessions per week).~     Following completion of the program, children and their parents will be asked to return to~     clinic for a follow-up visit. After a five to eight-week waiting period, children in the~     waitlist condition will also be asked to return to clinic for a second visit. Following this~     assessment, participants initially enrolled in the waitlist will be offered an opportunity to~     participant in the intervention. If interested, they will follow the same intervention~     protocol described above. These children will return to clinic for a third visit following~     completion of the intervention. Compliance rate and its confidence interval will be~     calculated for the overall study population. A t-test for binomial proportion with continuity~     correction will be used to examine whether the compliance rate is lower than the target.~     Participants' change in criterion outcomes will be evaluated (i.e., those neurocognitive~     measures such as attention, executive functioning and working memory, that are most closely~     related to the trained tasks).~   "
135497|NCT01793727|"~     A prospective trial evaluating the learning curve associated with the use of a~     videolaryngoscope compared to conventional direct laryngoscopy in infants intubated by~     anesthesiology residents. Hypothesis: The learning curves of both instruments are equivalent.~   "
135498|NCT01793714|"~     One of the aim of the neurosurgical treatment of brain tumor is to offer the maximal~     resection with the minimal neurological risk. The presurgical mapping of eloquent areas with~     functional magnetic resonance imaging (fMRI) is helpful to plan the surgery. BOLD fMRI is now~     the gold standard to map language areas. However, BOLD signal is diminished near the brain~     tumor. It is now possible to detect cortical activation with arterial spin labeling (ASL)~     techniques, detecting variations of perfusion during an activation paradigm (fASL), fASL~     could be interesting to detect eloquent areas near a brain tumor.~   "
135499|NCT01793701|"~     This will be the first study to assess the clinical feasibility of dose escalation with~     simultaneous integrated boost intensity-modulated radiotherapy for patients with locally~     advanced cervical cancer. Following screening to confirm eligibility patients will commence a~     six week treatment period. After this, patients will be followed up by visits to clinic every~     3 months for a period of 24 months (2 years). End of study is defined as 24 months after~     treatment. Patients will be followed up for a minimum of 5 years (as per local policy) after~     treatment.~   "
135500|NCT01793688|"~     The purpose of the survey is to study the followings under practical use, regarding the~     safety and effectiveness in high-dose administration (exceeding 6 g per day) of UNASYN-S and~     UNASYN-S KIT for intravenous use (UNASYN).~        1. Adverse Drug Reaction(s) that cannot be expected from precautions (Unexpected Adverse~          Drug Reaction)~        2. Incidence status of adverse drug reactions~        3. Factors that may affect the safety and effectiveness~   "
136075|NCT01786096|"~     This is a phase 1, open-label, dose-escalation, multicenter study to evaluate the safety and~     tolerability of SGN-CD19A in adult and pediatric patients with relapsed or refractory~     B-lineage acute lymphoblastic leukemia (B-ALL), Burkitt lymphoma or leukemia, or B-lineage~     lymphoblastic lymphoma (B-LBL).~   "
135501|NCT01793675|"~     Allogeneic hematopoietic stem cell transplantation (HSCT) is currently the only curative~     treatment for myelodysplastic syndrome (MDS), especially for advanced MDS (blast >5%).~     However, many patients cannot find an HLA-matched donor. haploidentical donor is an~     alternative stem cell source.~      the study hypothesis: Haploidentical/mismatched hematopoietic stem cell transplantation can~     improve the survival of patients with myelodysplastic syndrome~   "
135502|NCT01793662|"~     Patients with severe atherosclerotic occlusive disease can be operated with an aortobifemoral~     bypass(ABFB)through a median laparotomy. Since 1993, the vary operation has also been~     performed laparoscopically. The laparoscopic ABFB operation claims to be minimally invasive~     as compared to the open ABFB. The cohort studies published so far have shown that although a~     longer operation time with the laparoscopic procedure as compared to the open surgery, the~     patients have a shorter hospital stay, lesser perioperative bleeding, fewer systemic~     complications and earlier reconvalescence.~      However, no randomized control trial has yet been published to compare the two procedures.~      In the NLAST-study, which is a multicenter randomized control trial, the patients with TASC~     type D atherosclerotic lesion shall be randomized to either totally laparoscopic~     aortobifemoral bypass operation (LABFB)or an open ABFB operation.~   "
135503|NCT01793649|"~     This is a randomized, double-blind, cross-over, vehicle-controlled study to determine whether~     GS-5737 in 2.8% saline accelerates mucociliary clearance (MCC) in healthy subjects, compared~     to vehicle of 2.8% saline alone.~   "
135504|NCT01793636|"~     When kidney cancer spreads beyond the kidney, it is known as metastatic kidney cancer. This~     is very difficult to treat and almost all patients will die of their disease within 2 years~     of the diagnosis.~      Sunitinib and other related drugs (e.g. pazopanib) have become standard therapy for untreated~     patients with metastatic kidney cancer. They target a growth factor known as VEGF which is~     important in treating kidney cancer. Although the results with this drug are impressive,~     patients develop resistance to the drug and stop therapy. It is currently standard practice~     is to give everolimus when resistance to sunitinib occurs; this is associated with clear~     clinical benefit.~      However the average time to cancer regrowth with everolimus is only 5 months. It is thought~     this might be because, everolimus only partially inhibits its target (TORC 1 and TORC 2).~     Therefore further improvement in treating patients is required. AZD2014 is a promising new~     drug which does inhibit both TORC 1 and TORC 2 and is therefore worthy of investigation in~     renal cancer as it theoretically could may have advantages over everolimus. Therefore study~     compares AZD2014 to everolimus in the setting where everolimus is used as standard of care.~     (e.g. in patients who have failed drug like sunitinib). The study is a randomised trial~     allowing us to quantify the benefit and potential for further development of AZD2014. Repeat~     Xrays (CT scans) will be used to assess if the new drug delays tumour growth. Patients will~     be closely followed up in clinic to ensure safety. A maximum of 122 patients will be~     recruited into this multi centre national trial. The primary goal of the study is to~     investigate if AZ2014 delays the time for cancer regrowth (time to progression) compared to~     everolimus.~   "
135505|NCT01793623|"~     Over the past decade, techniques have been refined which permit an enormous amount of~     information relevant to disease mechanisms to be gained from the examination of heart tissue.~     The Cardiovascular Institute has extensive experience with these techniques, and has utilized~     them to examine other heart disease substrates. In this study, the investigators propose to~     obtain heart tissue at the time of cardiac surgery which would otherwise be discarded. Their~     plan is to examine this tissue and correlate their findings with clinical data. Their hope is~     that the proposed study will provide insight into atrial physiology, including the molecular~     mechanisms underlying atrial disease and the potential development of atrial fibrillation~     (AF).~   "
135506|NCT01793610|"~     This small (pilot) study is designed to provide information on whether psychotherapy~     combined with the drug MDMA is safe and helpful for people with posttraumatic stress disorder~     (PTSD). The researchers plan to use the results of this study to design further studies. This~     study will compare two doses of MDMA active dose 1, two doses of MDMA active dose 2, or~     comparator-dose MDMA. There will be an initial dose possibly followed one and a half to two~     and a half hours later by a second dose half the size of the first dose. The study will~     measure symptoms of PTSD, depression, general psychological well-being and sleep after a low~     dose versus active doses of MDMA. Subjects experiencing pain or tinnitus (ringing in the~     ears) at the start of the study will report on levels of pain or tinnitus during the study.~     The study will also examine whether following the standardized treatment is related to~     changes in PTSD symptoms. Subjects will be prepared for MDMA-assisted psychotherapy prior to~     the first session, and he or she will work with the same pair of therapists after having two~     MDMA-assisted psychotherapy sessions, with the second session occurring three to five weeks~     after the first session. Symptoms of PTSD, depression, general psychological well-being,~     feeling that you or the world are unreal (dissociation), potential positive effects of~     traumatic events and sleep quality will be assessed one month after the second MDMA-assisted~     session. Cognitive function will be measured one month after the second MDMA-assisted~     session. Participants who received comparator-dose MDMA can enroll in Stage 2, wherein they~     will have three MDMA-assisted psychotherapy sessions. People who received either active-dose~     MDMA will have a third MDMA-assisted session. Cognitive function will be measured again after~     two months last Stage 1 or Stage 2 MDMA-assisted session.Subject PTSD symptoms, depression~     psychological symptoms, other symptoms and sleep two months after their final MDMA-assisted~     session and at least 12 months after they began the study.~   "
135507|NCT01793597|"~     Patients who have a heart attack are regularly treated with either clopidogrel or ticagrelor.~     In a large clinical trial, treatment with ticagrelor before coronary bypass surgery (CABG)~     was associated with a lower risk of death than treatment with clopidogrel. The reason for~     this difference cannot be explained on the basis of the study. One possible explanation is~     that the reversible binding of ticagrelor is advantageous because when new platelets are~     released, they are inhibited by the drug. Because clopidogrel binds irreversibly it cannot~     redistribute. The investigators will recruit patients who are scheduled for surgery after an~     acute coronary syndrome who have been treated with either ticagrelor or clopidogrel. After~     the patient provides informed consent, the investigators will review their medical~     record,record information and on the day after surgery the investigators will take one sample~     of blood. That blood will be analyzed for evidence of platelet activation (platelet~     microparticles, and platelet-leukocyte aggregates), the reactivity of young platelets, and~     the concentration of inflammatory cytokines. The investigators hypothesize that the evidence~     of platelet activation (platelet microparticles and platelet-leukocyte aggregates) and the~     reactivity of young platelets will be less in patients who have been treated previously with~     ticagrelor.~   "
135508|NCT01793584|"~     The purpose of the proposed pilot study is to investigate the effectiveness, cost, safety,~     and long-term impact on quality of life of laparoscopic hysterectomy (LH) in relation to~     abdominal hysterectomy (AH) for the treatment of benign gynecologic disease in women through~     a randomized surgical trial.~   "
145018|NCT01669187|"~     It is expected that patients who receive physical therapy before surgery will have greater~     range of motion (ROM), strength, function, satisfaction, and less swelling, pain, and anxiety~     following surgery compared to those in the control group.~   "
135510|NCT01793558|"~     This study should evaluate whether newborns during cesarean section are endangered to get~     hypothermic while bonding on the mothers chest.~      Therefore, the investigators want to investigate the effects of active cutaneous warming of~     the mothers and babies during intraoperative bonding. The investigators plan to enroll 40~     parturients scheduled for elective caesarean section to receive passive insulation or~     forced-air skin surface warming. The investigators will measure core temperature of the~     newborns and their mothers. The investigators hypothesize that newborns became most often~     hypothermic without active warming during the bonding procedure and that active warming will~     be able to decrease the number of hypothermic newborns significantly.~   "
135511|NCT01793545|"~     Background:~      - Endometrial cancer is one of the most common gynecologic cancers. If it is caught at an~     early stage, it can be treated more easily. Women who have this type of cancer often have a~     history of irregular menstrual bleeding. They may also have abnormal findings during~     gynecologic exams. Pap smears and cervical cell collection may be able to collect cell~     samples for cancer testing. However, samples from the vagina or endometrium may produce more~     accurate results. Researchers want to collect vaginal and endometrial cell samples to improve~     their tests for and understanding of endometrial cancer.~      Objectives:~      - To collect vaginal and endometrial cell samples to study endometrial cancer.~      Eligibility:~      - Women at least 18 years of age who have had symptoms of abnormal uterine or post-menopausal~     bleeding, or abnormal ultrasound findings.~      Design:~        -  Participants will be screened with a physical exam and medical history.~        -  Participants will have a pelvic exam. Before the exam, they will insert a small tampon~          in the vagina. The tampon will stay in place for about 10 to 30 minutes. The tampon will~          then be removed and collected for the study.~        -  During the pelvic exam, tissue will be collected from the uterine lining with a special~          brush. An additional sample (biopsy) will be collected from the lining.~        -  A blood sample will also be collected as part of the study.~   "
135512|NCT01793532|"~     Background:~      - Some people with epilepsy have an epileptic focus, a small part of the brain that is the~     starting point of the seizure. This focus is like an irritant or an inflammation, and helps~     cause the seizure. People with epilepsy that affects the temporal lobe of the brain often~     have an epileptic focus. Researchers want to look at the epileptic focus by using a drug that~     attaches to a protein associated with inflammation. An imaging study with the drug will show~     how much inflammation is in the area of the brain where the seizures start. The drug, called~     [11C]DPA-713, will be tested for its effectiveness in people with temporal lobe epilepsy. Its~     effects will be compared with imaging studies given to healthy volunteers.~      Objectives:~      - To see if [11C]DPA-713 can show the inflammation in the epileptic focus of seizures.~      Eligibility:~        -  Individuals at least 18 years of age who have temporal lobe epilepsy.~        -  Healthy volunteers at least 18 years of age.~      Design:~        -  Participants will have three outpatient visits to the National Institutes of Health~          Clinical Center. The visits will last from 2 to 5 hours.~        -  Participants will be screened with a physical exam, neurological exam, and medical~          history. Blood samples will be collected before the start of the study.~        -  Participants will have a positron emission tomography (PET) scan. This scan will be used~          to look at brain chemistry and function. The study drug will be given during the scan to~          see how well it shows points of inflammation in the brain. Some participants will~          provide additional blood samples during the PET scan.~        -  Participants will also have a magnetic resonance imaging (MRI) scan. This scan will look~          at the structure of the brain.~   "
135513|NCT01793519|"~     Background:~        -  Rheumatoid arthritis (RA) is often treated with drugs known as tumor necrosis factor~          (TNF) inhibitors, that can help decrease joint pain and swelling and can even result in~          RA remission. However, TNF inhibitors may increase risk of serious infections or some~          types of cancer.~        -  It is not clear if people whose RA has been in remission for a long time need to stay on~          the TNF inhibitor to remain in remission. If they can stop taking the TNF inhibitor~          without having their symptoms come back, they will be spared the side effects of these~          medicines. Some studies have shown that people can stay in remission after stopping a~          TNF inhibitor, but other studies have not confirmed it. Researchers want to see if~          people with RA in remission on a TNF inhibitor can stay in remission without this~          medicine. Also there may be a clinical, imaging (MRI, ultrasound), laboratory profile~          that will help to determine which patients remain in remission after stopping these~          drugs.~      Objectives:~        -  To see whether RA remission can continue after discontinuing use of a TNF inhibitor.~        -  To determine if clinical, imaging and immunological measurements can predict which~          participants will flare and which will remain in remission after discontinuing TNF~          inhibitor.~      Eligibility:~      -Individuals at least 18 years of age who have RA that is being controlled with TNF~     inhibitors. We plan to randomize 291 patients.~      Design:~        -  The study has seven visits over about 2 years. Six visits occur in the first year of the~          study, about 12 weeks apart. The final study visit is 1 year after the end of the~          treatment phase.~        -  At the first visit, participants will be screened with a physical exam and medical~          history. They will complete a questionnaire about their RA symptoms. A blood sample will~          be collected. They will continue to take their RA medicines during this time.~        -  The second visit will repeat tests from the first visit. These tests will confirm that~          the RA is in remission. Imaging studies will be performed on the hands, wrists, feet,~          and their connected joints. After this visit, participants will stop taking their TNF~          inhibitors and will start to have injections of a study drug. This drug will be either~          the participant's original TNF inhibitor or a placebo.~        -  There will be follow-up visits at weeks 12, 24, and 36. Participants will have a medical~          history and joint exam. They will also provide blood samples and answer questions about~          their RA symptoms.~        -  At the sixth visit (week 48), participants will repeat the tests and imaging studies~          from the second visit. They will stop taking the study injections.~        -  Continued RA treatment after this visit will be decided by the participant and his or~          her rheumatologist. Participants may take any recommended medicine, including the TNF~          inhibitor they had been taking before the study. They will also receive a questionnaire~          to complete at home and mail back before the final study visit.~        -  At the final visit (week 100), participants will repeat the tests and imaging studies~          from the second and sixth visits.~   "
135514|NCT01793506|"~     The purpose of this study is to evaluate a novel screening test to detect patients with~     primary immunodeficiencies(PIDs). The investigators plan to use information gained from this~     study in order to advance the field of clinical immunology, thus improving the diagnosis,~     treatment, and well-being of future patients. The purpose of this study is to determine if~     this screening test is able to detect patients with immune problems, and the investigators~     will test patients with known PIDs to determine if the test is accurate~      The investigators hypothesize that detecting serum immunoglobulins from dried blood spots~     will be effective in detecting patients with known primary immunodeficiencies. If our~     hypothesis is confirmed, it opens the possibility of using point of care testing to screen~     for primary immune deficiencies.~      Age of study subjects will range from 1 year to 80 years of age, and will be recruited form~     the Immunodeficiency clinic at the Medical College of Wisconsin/Children's Hospital of~     Wisconsin (MCW/CHW). Any subject having testing done to evaluate the immune system is~     eligible for this study. This will include patients with known PIDs as well as patients~     evaluated for a suspected immunodeficiency. It is anticipated that 150 subjects will be~     analyzed over a two year period.~   "
136467|NCT01780987|"~     The purpose of this study is to investigate safety of apixaban in Japanese acute DVT/PE~     subjects when symptomatic DVT/PE subjects are treated with 10 mg BID apixaban for 7 days as~     initial therapy followed by 5 mg BID apixaban for 23 weeks as long-term therapy (total~     treatment period is 24 weeks)~   "
135516|NCT01793480|"~     This is a multicentric, randomized, open-label, phase IIIb national study, to evaluate the~     clinical effects (success/failure) of methadone for the treatment of cancer-related-pain in~     patients with inadequate pain relief or intolerable side effects when treated with level 3~     opioid.~      Principal objective is to compare the clinical effects (success/failure) of two methods of~     methadone titration in patients with cancer-related pain inadequately relieved or with~     intolerable side effects after treatment with level 3 opioid.~      Secondary objectives are : Overall safety of methadone during the study, to describe the~     patients' characteristics, to describe the effects of methadone on pain relief, to describe~     the methadone administration, to evaluate patient's quality of life, to evaluate the~     prescriber's opinion regarding the handling of methadone initiation.~   "
135517|NCT01793467|"~     Raltegravir (RAL) is a preferred option for initial antiretroviral therapy in the most recent~     HIV Treatment Guidelines and is emerging as a popular choice for use in the specialized~     population of HIV-infected patients being considered for solid organ transplantation. Data~     from HIV-infected persons with normal organ function have revealed few raltegravir-associated~     metabolic complications compared to older antiretrovirals, and in general, drug-drug~     interactions with raltegravir are infrequent. The absence of such concerns appears to make~     raltegravir a potentially appealing option for antiretroviral therapy in HIV-infected~     patients being considered for solid organ transplantation.~      At present, however, little is known of the safety and long term tolerability of~     RAL-containing regimens in persons undergoing solid organ transplantation. As more~     HIV-infected patients undergo organ transplantation, there is a growing need for good data on~     such things as the effect of dialysis on RAL concentrations, the potential interactions with~     commonly used immunosuppressive drugs, and the pharmacokinetic (PK) /pharmacodynamic (PD)~     characteristics in those with end stage organ failure, as well as those with functioning~     grafts.~      The proposed study will also examine transplant function and survival in HIV-infected~     patients receiving RAL-containing ART and will compare it to HIV negative historic controls.~   "
135518|NCT01793454|"~     Our aim is to compare the effects of 80% and 40% Fraction of inspired oxygen on oxidative~     stress, antioxidant response (in plasma and bronchoalveolar lavage), extubation quality,~     preanesthetic and postanesthetic expiration tidal volumes.~   "
135519|NCT01793441|"~     This multi-center, randomized, double-blind, parallel group, placebo-controlled, proof of~     concept study will investigate the efficacy and safety of RG7314 in adult participants with~     ASD. In Stage I of the study, participants will be randomized in 2:1 to receive daily oral~     doses of 1.5 milligrams (mg) RG7314 or placebo for 12 weeks. After an independent safety~     review, the study may proceed to Stage II. In Stage II of the study, additional participants~     will be randomized in 2:1 to receive daily oral doses of 4 mg RG7314 or placebo for 12 weeks.~     After an independent safety review, Stage III will be started wherein additional participants~     will be randomized in 2:1 to receive daily oral doses of 10 mg RG7314 or placebo for 12~     weeks. During Stage III, safety will be reviewed by independent safety review twice and if no~     safety signal is observed, then additional participants will be randomized in 1:1:1 either to~     receive 1.5 milligrams per day (mg/day) or 10 mg/day RG7314 orally or placebo for 12 weeks in~     Stage IV.~   "
135520|NCT01793428|"~     13% of injured normotensive patients arriving in emergency unit need mass blood-transfusion~     of six or more units of packed Red Blood Cells. It is currently difficult to predict the need~     for such a mass blood-transfusion. Indeed hemoglobin point of care testing (hemocue) and~     blood pressure can be normal during the first hours despite intensive bleeding.~      It's well known that blood or arterial lactate measures correlate with trauma severity but~     these measures are not available in a pre-hospital setting. The investigators want to test~     whether capillary lactate measures also correlate with trauma severity and can therefore~     predicts earlier transfusion needs.~   "
135521|NCT01793415|"~     Chronic fatigue syndrome (CFS) is a devastating and complex disorder. People with CFS~     experience overwhelming fatigue and a host of other symptoms that are not improved by bed~     rest. Interestingly, many of the symptoms experienced by people with CFS are identical to~     symptoms caused by long-term low-level exposure to mercury, which is called~     micromercurialism.~      This study will examine if the mercury binding substance IodoCarb(r) can improve the health~     of patients with CFS.~   "
135522|NCT01793402|"~     Vitamin D is an essential nutrient. Deficiency of vitamin D is widespread. The prevalence of~     vitamin D deficiency in early preterm infants is unknown. The American Academy of Pediatrics~     recommends a daily intake of 400 IU in order to achieve a serum concentration of 20 ng/ml of~     vitamin D. This recommendation presumes exposure to sunlight, the best source of vitamin D.~     This study assesses vitamin D status at birth and during hospital stay in infants delivered~     delivered at earlier than or at 32 weeks gestation. We also assess the adequacy of intake~     relative to the target set by the American Academy of Pediatrics for children.~   "
135523|NCT01793389|"~     The present study deals with treatment of localized gingival recessions. The hypothesis of~     this study is that platelet rich fibrin can be used an alternative to subepithelial~     connective tissue graft in the coverage of denuded roots. If the platelet rich fibrin will~     prove to be similarly effective as subepithelial connective tissue graft, it will be possible~     to avoid a donor site and to decrease patient discomfort after operation.~   "
135524|NCT01793376|"~     Hypothesis This study is designed as an integral part of the development of a new CE score~     for Crohn's disease.~      The SB (small bowel) CD (Crohn's Disease)Niv score (CECDAI) is an established and validated~     CD score for SB involvement. In order to expand this score to the colon, this study will aim~     to develop the colonic score and later on will be combined with the already established SB~     score in order to achieve a full CE gut score for Crohn's disease Proposed Design This is a~     retrospective study in which up to 30 videos of colon Crohn's disease subjects who have~     undergone the Colon 2 CE procedure will be evaluated.~      These cases will have evidence of large and / or small bowel Crohn's disease The chosen~     videos will be marked for CD lesions by the site The de-identified marked videos will be~     scored by 4 independent experienced endoscopists, blinded to the results of the standard~     workup procedures, according to the colonic and CECDAIic new scores~   "
135525|NCT01793363|"~     Prospective, interventional multicentric study in ICU during weaning from mechanical~     ventilation in tracheotomized patients~   "
135526|NCT01793350|"~     A combined Phase 1 & 2 study to evaluate the safety and effectiveness of a new diabetic~     neuropathy topical cream, containing benfotiamine, will be performed at 5 clinical sites and~     plans for BC-DN-01 administration in up to 135 volunteer patients using a standard Phase 1 +~     2 design. Up to 15 subjects will receive BC-DN-01 in Study Phase 1 and up to 120 subjects~     will receive BC-DN-01 or placebo in Study Phase 2.~      In Phase 1, a BC-DN-01 dose delivering 160mg benfotiamine/day (80mg twice daily) will be~     administered for the first 7 days. On visit day 0, patients will commence study treatment.~     Patients will be interviewed by phone on day 3 and return to clinic on day 7 for safety~     assessments. If the drug is well-tolerated and no significant adverse events experienced, the~     total daily BC-DN-01 dose will be increased on days 7-14 to 320mg benfotiamine/day (160mg~     b.i.d.). Patients will be interviewed by telephone on day 10 and return to clinic on day 14~     for safety assessments.~      Once the safety profile has been determined in Phase 1 as acceptable, the Phase 2 study will~     be initiated to evaluate clinical efficacy of BC-DN-01. Phase 2 is a randomized,~     placebo-controlled, double-blind, parallel study. Participants receive placebo or BC-DN-01~     based on 1:1 randomization. Each patient will apply 4g of the study medication to each leg~     twice-a-day administering 320mg benfotiamine dose/day for 12 weeks.~      Participants will be evaluated in the clinic at baseline and at 4, 8, and 12-week time~     points; study staff will interview the patients by telephone on weeks 2, 6, and 10.~      The primary endpoint of the phase 2 trial is reduction in DPN pain measured by the Brief Pain~     Inventory. Phase 2 patients will be invited to give written consent to take part in biopsy~     sampling and additional gene expression analysis.~   "
135527|NCT01793337|"~     Accurate measurement of core body temperature at the scene of an accident is critical for~     both diagnosis and treatment/triage decisions for hypothermic patients. Measurement in the~     lower third of the oesophagus is considered the gold standard of CT reading, but invasive and~     hardly applicable with a conscious patient. Tympanic membrane sensors for CT reading have~     been widely tested by may be unreliable in extreme environmental temperatures. Similarly, the~     Double Sensor device is a non-invasive device and is promising for prehospital use but has~     not been sufficiently verified under very cold and hot environmental conditions. Furthermore,~     comparisons of different non-invasive methods with oesophageal measurement in extreme~     conditions are lacking. The objective of these studies is to compare different techniques of~     core body temperature measurement with exposure to cold and hot environments.~   "
135528|NCT01793324|"~     A study to evaluate the effectiveness of an update of educational materials with respect to~     evaluation of monitoring of metabolic parameters~   "
135529|NCT01793311|"~     The goal of the study is to determine the effect of different doses of caffeine on~     intraocular pressure. We hypothesized that higher dosage of caffeine would increase~     intraocular pressure more than lower doses.~      Eligible subjects will be randomized into three groups:~        1. group 1: intake of decaffeinated coffee~        2. group 2: intake of coffee with lower caffeine dose~        3. group 3: intake of coffee with higher caffeine dose~      Intraocular pressure will be measured at 0, 30, 60 and 90 minutes after coffee intake.~   "
135530|NCT01793298|"~     The purpose of this study is to evaluate the safety and tolerability of the dry powder~     formulation of ASM-024 following single and multiple administration by inhalation of~     ascending doses in healthy subjects and subjects with stable moderate asthma.~   "
135531|NCT01793285|"~     Previous studies suggest that an increase in doses of weekly etanercept from 50 mg to 100 mg~     improves the efficacy of the treatment in patients with cutaneous psoriasis, rheumatoid~     arthritis, and psoriatic arthritis. In this same line of study, during the 2007 2008 period,~     we conducted a multicenter, double-blind, 12-week Study (LoadET, 0881A3-102090) comparing the~     efficacy of etanercept at a standard dose (50 mg/week) versus a double dose (100 mg/week) in~     subjects with AS refractory to conventional therapy. The interim results of said study do not~     appear to support the value of doubling the dose of etanercept in the treatment of subjects~     with AS. Once this study was finalised, the subjects continued to be monitored by their~     regular physician, who decided on the dose and treatment to follow according to the~     conditions of standard clinical practice.~      The objective of this observational study is to evaluate the course of the disease in the~     long-term (three years) under the conditions of standard clinical practice, in subjects who~     had participated in the LoadET study. Therefore, we would like to follow-up on those patients~     by reviewing their clinical histories for the three-year period between the finalisation of~     their participation in the LoadET Study (0881A3-102090) and now. This will allow us to assess~     the efficacy and survival of the drug, as well as the possible appearance of side effects in~     the three years following the finalisation of the study by comparing the results according to~     if the subjects had received 50 mg/week or 100 mg/week during the LoadET study (0881A3~     102090).~   "
135532|NCT01793272|"~     To evaluate the effect of pentoxifylline used in preparation of semen samples that will be~     used for ICSI in infertile men complaining of mild and moderate asthenozoospermia (i.e. cases~     which does not need motility enhancement prior to ICSI) in comparison to semen samples~     without pentoxifylline preparation on the outcome of ICSI.~   "
135533|NCT01793259|"~     The primary objective of this study is to assess the number of patients preferring the~     methotrexate pre-filled pen to the methotrexate pre-filled syringe after 6 weeks of treatment~     based on a questionnaire~   "
135534|NCT01793246|"~     Patients will be enrolled that are undergoing bronchoscopy for diagnosis of discrete lung~     lesions or for detection of acute rejection following lung transplants. The hypothesis is~     that bronchoscopy together with probe-based endomicroscopy (pCLE)results in improved and/or~     incremental diagnostic yield (definitive diagnosis) over conventional bronchoscopy.~   "
135535|NCT01793233|"~     This clinical trial studies blood sample markers of reproductive hormones in assessing~     ovarian reserve in younger patients with newly diagnosed lymphomas. Studying samples of blood~     from patients with cancer in the laboratory may help measure the effect of curative therapy~     for lymphoma on ovarian failure.~   "
135543|NCT01793129|"~     This study is a randomized, controlled trial to assess safety and effectiveness of whole body~     hypothermia for 72 hours in preterm infants 33-35 weeks gestational age (GA) who present at~     <6 hours postnatal age with moderate to severe neonatal encephalopathy (NE). The study will~     enroll infants with signs of NE at 18 NICHD Neonatal Research Network sites, and randomly~     assign them to either receive hypothermia or participate in a non-cooled control group.~   "
135536|NCT01793220|"~     The aim of this research is to find out if mobile phone text message reminders of~     appointments can help to address missed appointments in Psychosis Community Services. Another~     aim is to examine if fewer missed appointments result in clinical benefits for service users~     and in lower costs for Psychosis Community Services over a period of 6 months. 600 users from~     2 London Psychosis Community Services will take part in this research. Each participant will~     be put into one of two groups, as s/he joins the study: In the first (experimental) group,~     each participant will receive appointment reminders for 6 months (7 and 1 day/s before each~     appointment), starting with the first available opportunity upon joining the study. In the~     second (control) group, each participant will not receive appointment reminders for 6 months.~     The choice of group for each individual will be made at random by a computer. Clinical~     information will be collected for 6 months from the time each participant joins the study,~     using, with his or her consent, their anonymised electronic medical records. The following~     clinical information will be compared between the experimental and control groups: Attendance~     of appointments, number of inpatient admissions, number of days in inpatient care, number of~     inpatient admissions under the mental health treatment act, number of referrals to a home~     treatment team, number of times patient has changed medication, health and social~     functioning. Service use, service costs and the cost-effectiveness of the reminder system~     will also be examined. Towards the end of their participation, service users, as well as~     mental health professionals, will be invited to express their views, concerns and suggestions~     in relation to the reminder service by completing a brief anonymised (service users) or~     anonymous (staff) questionnaire~   "
135537|NCT01793207|"~     The incidence of colorectal cancer (CRC) is on the rise on a global scale. The number of~     cancer-related deaths related to CRC is also rising to an alarming level. This picture is~     similarly seen in Egypt where the incidence of colorectal carcinoma is increasing annually,~     moreover, CRC in Egypt exhibits an alarming characteristic which is the affection of much~     younger patients than their counterparts worldwide. Fortunately, the early detection of CRC~     and its precursor (adenoma) has been shown to markedly decrease morbidity and mortality~     related to this tumor, this has prompted the development of robust screening programs for CRC~     in several western countries. The implementation of a CRC screening program in Egypt has been~     hampered by the low compliance of the patients and the relatively high cost of colonoscopy.~     There is a need for an affordable, non-invasive, simple, accurate and socially accepted~     screening test to allow such a program to succeed in Egypt. Recent studies have shown that~     DNA is the future target of screening tests for several malignancies. Particularly for CRC a~     few preliminary studies have shown encouraging results with separate DNA methylation markers~     both in blood and stool. In our efforts to develop a screening test with the criteria stated~     above, the investigators have decided to join the forces of 2 of the largest medical centers~     in Egypt and the middle-east: Kasr-Alaini hospital and the National cancer institute (NCI).~     The investigators plan to test a panel of 7 DNA methylation markers in peripheral blood for~     their performance as an early marker for CRC and colorectal adenomas. Data from this study~     will pave the way for the development of a screening test for CRC tailored to the Egyptian~     population, moreover, it will supply essential data about the genetic alterations occurring~     in CRC in Egyptian patients.~   "
135538|NCT01793194|"~     Problem: Approximately 4 million live births occur in the United States each year. Pregnancy~     causes many physical changes in the mother, including venous distension, increased ability to~     form blood clots, and hormonal changes. Data suggest that these factors help cause venous~     insufficiency (when the veins do not adequately return blood from the extremities to the~     torso). As venous insufficiency progresses, complications follow, the most severe of which~     include superficial thrombophlebitis and deep venous thrombosis (DVT, or blood clots).~     Although the fear of DVT has been well publicized, its prevention and prevalence in pregnant~     women has not been well-studied.~      The exact cause of venous insufficiency is not known. However, known risk factors include~     being female and hormonal changes associated with oral contraceptive use, certain hormone~     replacement medications, and pregnancy. Being pregnant places the mother at additional risk~     for developing venous insufficiency.~      Compression stockings are used to manage the condition, but this is by no means standard of~     care despite their easy use and safety. The medical community's understanding of how~     compression stockings work is largely theoretical; however, it is believed that the~     compression works by preventing venous hypertension in the lower legs, thereby preventing~     venous insufficiency and its associated complications.~      Research hypothesis: The investigators hypothesize that compression stocking use will be~     associated with lower incidence of varicose veins and, in those patients who already have~     varicose veins, lower incidence of complications associated with venous insufficiency.~     Further, the investigators believe that compression stocking use will be associated with a~     lower incidence or lessening of symptoms associated with venous insufficiency.~      Importance: An undetected DVT can be fatal. Even if detected promptly, DVT is associated with~     long term health problems. Treatment of a DVT requires anticoagulation which can be risky to~     both mother and fetus. The prevention or reduction of DVT in pregnant women through use of~     compression stockings would revolutionize their care. Further, this intervention is safe and~     noninvasive.~      The investigators propose to conduct a randomized, pilot study comparing pregnant women~     without and with varicose veins randomized to wear compression stockings to a similar group~     of participants randomized to no compression stocking use.~   "
135539|NCT01793181|"~     Retinal vein occlusion (RVO) is a common vascular disease of the eye. Studies have shown that~     the risk of venous thrombosis is higher in winter so even concerning RVO. Studies have shown~     a possible link between sun exposure and venous thrombosis. Vitamin D levels have been shown~     to have a similar seasonal variation, with a peak occurring in the summer. The primary source~     of vitamin D is from sunlight when ultraviolet B (UVB) radiation penetrates the skin and~     converts 7-dehydrocholesterol to 25-hydroxycholecalciferol vitamin D3 (25-OHVitD) via~     previtamin D. In Stockholm situated at latitude 59˚ 20΄ North, it is not possible to~     synthesize vitamin D at sufficient levels in winter and the exposure time required to reach a~     standard dose is impractical from at least October through March.~      The aim of the study is to evaluate vitamin D levels in central retinal vein occlusion (CRVO)~     patients and compare them with the vitamin D levels in randomly selected control patients~     matched for age and month of disease onset. This is to evaluate whether vitamin D deficiency~     may be a risk factor in the onset of CRVO.~      The hypothesis of the study is that patients with CRVO have lower levels of vitamin d than~     matched controls.~   "
135540|NCT01793168|"~     CoRDS, or the Coordination of Rare Diseases at Sanford, is based at Sanford Research in Sioux~     Falls, South Dakota. It provides researchers with a centralized, international patient~     registry for all rare diseases. This program allows patients and researchers to connect as~     easily as possible to help advance treatments and cures for rare diseases. The CoRDS team~     works with patient advocacy groups, individuals and researchers to help in the advancement of~     research in over 7,000 rare diseases. The registry is free for patients to enroll and~     researchers to access. Visit sanfordresearch.org/CoRDS to enroll.~   "
135541|NCT01793155|"~     The purpose of this study is to evaluate the effects of postoperative inspiratory muscle~     training on the recovery of respiratory muscle strength in high risk patients referred for~     lung cancer surgery. Furthermore, to assess longitudinal changes in respiratory muscle~     strength, physical capacity and health-related quality of life after lung cancer surgery~   "
135542|NCT01793142|"~     This survey is conducted for preparing application material for re examination under the~     Pharmaceutical Affairs Laws and its Enforcement Regulation, and assessing the safety and~     efficacy profiles of VIVIANT in usual practice according to the Re-examination Regulation for~     New Drugs~   "
135544|NCT01793116|"~     This is a registry of moderate preterm infants, born alive at 29-33 weeks gestational age, in~     NICHD Neonatal Research Network (NRN) centers. The registry collects observational baseline~     data on both mothers and infants, and the therapies used and outcomes of the infants. The~     information collected is not specific to a disease or treatment (i.e., it is generic). Data~     are analyzed to find associations and trends between baseline information, treatments, and~     infant outcome, and to develop future NRN trials.~   "
135545|NCT01793103|"~     The goal of the present study is to establish a prospective observational cohort of~     Rheumatoid Arthritis patients in order to~        1. Determine and validate biomarkers that predict drug response and toxicity in RA.~        2. Determine and validate biomarkers that predict disease activity and prognosis in RA.~        3. Evaluate the natural history of treated RA in terms of its clinical, functional and~          economic outcomes.~   "
135546|NCT01793090|"~     The aim of the research is to investigate the safety and efficacy of EPI-743 treatment in~     patients with Cbl-C defect and related visual and neurological impairment. Primary Endpoints~     will be the improvement in visual function as assessed by visual acuity and eye-hand~     coordination and manual dexterity. Secondary Endpoints will be the improvement in neurologic~     function, evaluated by a battery of age-appropriated psychophysical tests, and/or in~     objective electrophysiological tests such as Visual Evoked potentials (VEP) and~     Electroretinogram (ERG) and/or the change in serum markers of redox state.~   "
135547|NCT01793077|"~     Tremodi is an observational, non-interventional, prospective, open-label, non-comparative~     study that will collect real life data of a treatment with Depo-Eligard® in 3 different~     administrations in male prostate cancer patients.~      Once the examining physician has decided on the therapeutic approach and if the selection~     criteria are fulfilled, he will propose the patient to participate in the study. An informed~     consent form will be collected for all participants in the study.~      There are 2 possible study visits that coincide with a routine consultation, namely visit 1~     (inclusion visit) and visit 2 (end of study visit). On both visits, Adverse Drug Reactions~     (adverse event caused by Depo-Eligard®) are collected and the patient will be asked to~     complete a Quality Of Life questionnaire (EORTC QLQ-C30). At visit 2, the examining physician~     will give a global evaluation of the treatment with Depo-Eligard® and assesses the treatment~     benefit of the patient.~      Testosterone and Prostate Specific Antigen (PSA) blood values are collected during both~     visits, if available.~   "
135548|NCT01793064|"~     The purpose of this study is to develop and evaluate an adaptive shaping intervention based~     on Behavioral Economics and Operant principles to promote physical activity behaviors~     (adaptive group) and compare to a static physical activity intervention (static group) using~     a two-group randomized controlled trial design. Participants will include 20 overweight men~     and women (BMI 25-35 kg/m2) between 18 to 55 years. Both groups will receive the following~     components: 1) a pedometer, 2) self-monitoring of physical activity, 3) brief educational~     materials, 4) motivational prompts, 5) physical activity goals, and 6) small financial~     incentives. The Adaptive Intervention (AI) group will receive adaptive goals and feedback~     based on percentiles and a moving window of their recent physical activity, with incentives~     linked to goal attainment. Comparison intervention participants will receive the static~     10,000 steps per day goal, with matching incentive amounts but without incentives linked to~     goal attainment. The study will compare differences in goal setting and shaping procedures~     that aim to increase physical activity behavior.~      Primary aims include:~        1. To determine whether physical activity (pedometer-measured steps/day) in both the~          Adaptive and Static interventions increased compared to their respective baselines.~          Hypothesis: Both the adaptive and static interventions will result in increased physical~          activity over 6 months.~        2. To evaluate whether the Adaptive Intervention results in greater change in physical~          activity (pedometer-measured steps/day) compared to the Static Intervention. Hypothesis:~          The adaptive intervention will result in significantly greater physical activity,~          measured by pedometer, compared to the static intervention over 6 months.~        3. To assess participants' satisfaction with the overall program. Hypothesis: Adaptive~          Intervention participants will report greater overall satisfaction with the intervention~          than the Static Intervention participants.~   "
135549|NCT01793051|"~     The goal of this clinical research study is to learn if minocycline can help reduce the~     symptoms reported by patients with MM who receive therapy with lenalidomide.~      Minocycline is an antibiotic and has been shown to interrupt pro-inflammatory cytokine~     production, which may help to reduce multiple symptoms.~   "
135550|NCT01793038|"~     Polycystic ovarian syndrome (PCOS) is a condition characterized by infertility, infrequent~     periods and amenorrhea or irregular bleeding plus anovulatory infertility. Clomid is the~     standard first drug of treatment for ovulation induction. Ovulation and conception will occur~     in approximately 75 and 30 percent of cases respectively. Cases not ovulating in response to~     doses of clomid up to 150 mg/day are known as clomid resistant PCOS.~   "
135551|NCT01793025|"~     The purpose of this study is to assess the safety and efficacy of infusing immune cells from~     a donor as treatment for patients with acute myeloid leukemia that is resistant to~     chemotherapy or who have experienced relapse. Unlike standard bone marrow or stem cell~     transplantation which uses donors who are well 'matched' to the patient, this study uses~     donors whose immune cells are not compatible with the patient. With standard stem cell or~     bone marrow transplantation, the well-matched immune cells will attack the leukemia but they~     also attack the patient's organs (a situation called graft-versus-host disease, which can~     persist in the long term). Our hypothesis is that the mismatched donor cells will fight the~     leukemia but will then be eliminated from the patient's body, so long-term side effects like~     graft-versus-host disease should not occur.~   "
135552|NCT01793012|"~     Infections are critical factors for the survival of critically ill patients. A broad,~     high-dose and early initial therapy of antibiotics is of particular relevance.~      A serious problem is the high variability of antibiotic serum concentrations after~     administration of antibiotics in patients of the critical care units. This may result in the~     risk of underdosage with possible ineffective therapeutic levels as well as in the risk of~     overdosage with possible adverse and toxic effects. The goal of this study is to determine~     antibiotic concentrations in blood and to evaluate concentrations with the course of the~     therapy. The measurement of antibiotic concentrations in blood may allow an individual~     adaption of the dose in future.~      100 - 200 patients will be included in this study. Only critically ill patients of the ICU of~     the Department of Anaesthesiology will be included that receive one or more of the following~     antibiotics: piperacillin/tazobactam, cefepime, meropenem, ciprofloxacin, linezolid, and~     colistin.~   "
135553|NCT01792999|"~     This study is conducted to compare Koning Breast CT (KBCT) to mammography to evaluate if KBCT~     can improve the diagnostic accuracy of breast cancer. It will also compare contrast-enhanced~     KBCT (CE-KBCT) to mammography to evaluate if CE-KBCT can further improve the diagnostic~     accuracy of breast cancer.~   "
136065|NCT01786226|"~     Objectives: to evaluate the efficacy, safety and quality of life by using 2.5 and~     mifepristone 5 mg daily doses to treat uterine fibroids over 3 months with a 9 months~     follow-up period.~      The hypothesis of the study is that the 2.5 mg dosage resulted in a lesser reduction in~     fibroid size but a similar improvement in quality of life when compared to the 5 mg dose.~   "
135554|NCT01792986|"~     This study will determine whether an intensive fasting protocol alters hemoglobin A1c~     measurements or other markers of metabolic and cardiovascular risk by performing a 5-week~     clinical trial of fasting among 12 pre-diabetic individuals or diabetics whose disease is~     controlled by diet. Participants will undergo a 5-week intervention of once-per-week 24-hour~     water-only fasting, including at baseline and at the end of the week for each week of the~     study (a total of 6 24-hour fasts).~   "
135555|NCT01792973|"~     HIV-infected women are at high risk of developing cervical cancer. This is a 3-year cohort~     study nested in the already existing Program for HIV Prevention and Treatment (PHPT) cohort~     of HIV-infected patients in Thailand (NCT 00433030). The main objective is to assess the~     prevalence, incidence, and clearance rate of HPV cervical infection and associated cervical~     lesion. The study will also provide the distribution of the HPV genotypes involved as well as~     other risk factors of cervical lesions. HIV-infected women receiving antiretrovirals, older~     than18 years of age, followed in the PHPT cohort or in the same hospitals are proposed to~     participate. An annual gynecological examination with a Pap-smear and a sampling for HPV~     testing is performed. Women with abnormal Pap-smear or with High-Risk HPV (HR-HPV) infection~     receive a more intensive follow-up with a colposcopy and a biopsy if necessary. Treatment is~     provided according to the National Guidelines.~   "
135556|NCT01792960|"~     Set the Korean Familial Hypertrophic Cardiomyopathy (KFHC) registry to study the prevalence~     of gene mutations in Korean patients with familial hypertrophic cardiomyopathy~   "
135557|NCT01792947|"~     Based on the creation of a somato-autonomic reflex, the stimulation of sensory nerve~     terminals located in dermatome T6 may cause a reflex, whose efferent pathways end in vagal~     nerve branches stimulating the gastric wall, similarly to the gastric pacemaker.~      The aim of this study was to evaluate the effect of percutaneous electroneurostimulation~     (PENS) of T6 dermatome on appetite, weight loss and dietary compliance.~   "
135558|NCT01792934|"~     The purpose of this study is to compare overall survival rates of colorectal cancer patients~     with multi-organ metastases with an indication for first line systemic treatment randomized~     for treatment with combination chemotherapy or treatment with combination chemotherapy and~     additional maximal tumor debulking including surgical tumor resection, RFA, (DEBIRI-)TACE and~     SBRT, depending on best clinical judgement according to a standardized treatment algorithm.~     Our hypothesis is that maximal tumor debulking in addition to systemic treatment with~     chemotherapy and biologicals will provide an improvement in progression free and overall~     survival in this patient group.~   "
135559|NCT01792921|"~     Scientific Rationale: Many children with ADHD have serious difficulties in participation in~     daily occupations in their ecological settings. These difficulties have a pervasive negative~     impact on their everyday functioning and quality of life (QoL). Although pharmacological~     treatment has been proven effective in treating ADHD symptoms in many children, as have~     psychosocial interventions such as parent training, there is little evidence for integrative~     approaches that address the cognitive, volitional and social-environmental barriers to~     participation with this population. Although preliminary positive effects of a~     cognitive-function (Cog-Fun) treatment in occupational therapy on this population have been~     demonstrated, additional evidence is needed to confirm these initial findings. Methods:~     Initial results of our pilot study (N=17 children with ADHD) demonstrated significant~     moderate to large effects of Cog-Fun treatment, which targeted participation and executive~     functions in daily life. Significant effects were also found for a measure of self-efficacy~     and neuropsychological measures of attention, planning and organization. Parent ratings~     showed significant reduction of ADHD symptoms and improved QoL. The purpose of the current~     study is to replicate the pilot study findings in a randomized controlled trial. The study~     will be a randomized controlled trial with a crossover design, including 2 groups of children~     with ADHD attending elementary school and their parents. The research group (Group A, n=50)~     will receive three months of the Cog-Fun treatment, designed for a parent/child dyad and the~     control group (Group B, n=50) will be wait-listed and receive treatment after three months.~     Outcomes will include measures of participation, executive functions in daily life, child and~     parental self-efficacy, ADHD symptoms and QoL. The investigators expect to find a significant~     main effect of time (pre-post intervention), group (research vs. control) and a significant~     interaction effect (group x time) on executive and occupational outcome measures.~   "
135560|NCT01792908|"~     The aim of the present study was to establish whether Kinesio Tape (KT) on the ankle (Kase~     protocol for the lateral ankle ligament) improves Joint Position Sense (JPS) in healthy~     volunteers immediately after its application and 48 hours later.~   "
135561|NCT01792895|"~     The purpose of this study was to investigate the comparative effectiveness of high velocity~     and low amplitude (HVLA)vs Mobilization (Mob) vs Mobilization with movement technique (MWMT)~     in sample of patients with chronic neck pain (CNP). Secondly to evaluate the immediate~     effects in range of motion and pain thresholds, and the interaction between psychological~     factors and the outcomes of these three types of manual therapy.~      The hypothesis is that all manual therapies techniques will produce similar effects.~   "
135562|NCT01792882|"~     The study is intended to collect specimens to support the application of genome analysis~     technologies, including large-scale genome sequencing. This study will ultimately provide~     cancer researchers with specimens that they can use to develop comprehensive catalogs of~     genomic information on at least 50 types of human cancer. The study will create a resource~     available to the worldwide research community that could be used to identify and accelerate~     the development of new diagnostic and prognostic markers, new targets for pharmaceutical~     interventions, and new cancer prevention and treatment strategies. This study will be a~     competitive enrollment study conducted at multiple institutions.~   "
135570|NCT01792765|"~     Kidney stones are very common, and can inflict a significant degree of pain and renal damage.~     Some stones become obstructed in the ureter, the tube that drains the kidney. In order to~     remove these stones, an Urologist and their team use fluoroscopic guidance to do so, this~     involves continuous X-ray. Flouroscopy delivers a significant dose of radiation to the~     patient, as well as the health care team, which has been shown to have serious health~     consequences. Previous studies have shown that in certain populations, like pregnant women,~     stones can be managed using ultrasound guidance. The investigators propose that mid and~     distal ureteral stones could be managed using ultrasound guidance in conjunction with~     conventional stone removal techniques (ureteroscopy, lithotripsy, and ureteral stent~     placement), in lieu of fluoroscopy, thereby minimizing radiation to healthcare staff and~     patients.~      The investigators hypothesize that distal ureteral stones can be identified and efficiently~     fragmented and removed under ultrasound guidance in a safe and effective manner without the~     use of radiation.~   "
135621|NCT01792089|"~     8 healthy volunteers, 8 pre-bypass obese subjects, 8 subjects between 12-18 months~     post-bypass, and 8 subjects matched to the post-bypass patients will be studied after~     ingestion of two or three different of the following test-meals: A)cream and whey protein~     B)cream, whey protein and fructose + 13C6 fructose C)test meal with cream, whey protein,~     fructose and glucose + 13C6 fructose Their intestinal de novo lipogenesis will be estimated~     by measuring 13C-palmitate on triglyceride-rich lipoprotein particles associated with apoB48~     in blood~   "
135563|NCT01792856|"~     Jockey Club Early Psychosis (JCEP) project is a territory-wide specialized EI service that is~     launched in August 2009 and provides 3-year phase-specific intervention for adult patients~     presenting with first-episode psychosis (FEP) to psychiatric units of Hospital Authority~     (HA). To promote early functional recovery, JCEP project develops recovery-oriented~     intervention based on life coaching approach (recovery-oriented coaching) in addition to case~     management. This is a structured group-based coaching program incorporating~     cognitive-behavioural and solution-focused therapeutic components. The program facilitates~     patients to undergo active change process via identification of achievable goals, formulation~     of action plans, provision of feedback and progress monitoring for goal attainment. Subjects~     will be randomized (block size: 2) to receive either recovery-oriented coaching program~     (intervention group) or supportive therapy (control group).~      Intervention group Subjects are scheduled to receive a 6-month group-based recovery-oriented~     coaching program. This is a structured, manualised treatment program based on life coaching~     principles with cognitive-behavioural and solution-focused elements incorporated. It guides~     subjects to undergo an active, yet stepwise change process by stimulating motivation, setting~     achievable goals, generation of action plans via collaborative exploration, fostering~     self-regulatory capacity, and provision of autonomy-supportive treatment environment and peer~     support. Subjects' perceived competence, sense of control, self-management skills and hence~     functioning will be improved via successful experiences and positive feelings generated after~     attainment of self-initiated goals. Cognitive-behavioural techniques such as self-monitoring,~     activity scheduling and behavioural modification will be employed.~      Control group Subjects will receive group-based supportive therapy provided by case managers~     of JCEP project. The therapy provides patients with psychoeducation about psychosis, stress~     management, emotional and social support. Coaching and cognitive-behavioural techniques will~     not be incorporated. Therapy sessions and duration will be comparable to that of~     recovery-oriented coaching program.~      Assessments Each subject will be assessed at three time points, i.e., baseline before~     randomization (T1), 12 weeks (T2, post-phase I intervention) and 24 weeks (T3, post-phase II~     intervention). Assessments on symptomatology, functioning and subjective wellbeing will be~     administered at all time points. Cognitive and reinforcement learning assessments will be~     conducted at T1 and T3. functional magnetic resonance imaging (fMRI) will be performed at T1~     and T3 for the first 20 subjects recruited in each treatment group. A group of healthy~     volunteers matched in sex, age and educational level will be recruited from the community~     with fMRI, cognitive and reinforcement learning evaluations done at T1 and T3. To maintain~     blinding to treatment assignment, assessments will be conducted by research assistants who~     are independent of treatment delivery and randomization. Subjects will be trained to not~     reveal their treatment allocation before each follow-up assessment.~   "
135564|NCT01792843|"~     -  a data driven approach has identified different cognitive phenotypes in Parkinson's~          disease (PD)~        -  this heterogeneity possibly reflects the diversity of the neuronal damage caused by the~          disease~        -  we hypothesize that the different clinical presentations are associated to specific~          anatomical and functional correlates~   "
135565|NCT01792830|"~     Most coronary artery bypass graft surgery (CABG) patients develop high blood sugar while they~     are in the hospital. No studies have shown what the best insulin regimen is for CABG patients~     with type 2 diabetes is after going home from the hospital. Patients with high blood sugar~     and diabetes after cardiac bypass surgery will be followed for 3 months to look at how well~     their treatment(s) for diabetes work after discharge. Patients with diabetes will be~     discharged on oral antidiabetic drugs or with insulin glargine injections based on their~     sugar control. Patients with admission HbA1c < 7% (a laboratory value that shows the average~     blood sugar level in the body over 3 months) will be discharged on the same diabetes~     medications that they used before coming to the hospital. Those with an HbA1c between 7% and~     9% will be discharged on insulin glargine at 50%-80% of the dose used in the hospital and~     oral antidiabetic drugs. Those with an HbA1c > 9% will be discharged on glargine at 80-100%~     of the dose used in the hospital in addition to oral antidiabetic drugs or with insulin~     glargine and insulin glulisine. The primary outcome will be a change in HbA1c at 4 and 12~     weeks after discharge.~   "
135566|NCT01792817|"~     Multi-center, prospective, double-blind, randomized, sham-controlled pivotal study of~     non-invasive vagus nerve stimulation with the GammaCore® device for the acute treatment of~     cluster headache. The study compares the safety and effectiveness of an active treatment~     (GammaCore) against a sham treatment.~   "
135567|NCT01792804|"~     Increasing resistance to antibiotic agents has been recognized as a major health problem~     worldwide that will even aggravate due to the lack of new antimicrobial agents within the~     next decade [1]. This threat underscores the need to maximize clinical utility of existing~     antibiotics, through more rational prescription, e.g. optimizing duration of treatment.~      Staphylococcus aureus bloodstream infection (SAB) is a common disease with about 200,000~     cases occurring annually in Europe [2]. A course of at least 14 days of intravenous~     antimicrobials is considered standard therapy [3-5] in uncomplicated SAB. This relatively~     long course serves to prevent SAB-related complications (such as endocarditis and vertebral~     osteomyelitis) that may result from hematogenous dissemination to distant sites. However,~     there is insufficient evidence that a full course of intravenous antibiotic therapy is always~     required in patients with a low risk of SAB-related complications.~      In a multicenter, open-label, randomized controlled trial we aim to demonstrate that an early~     switch from intravenous to oral antimicrobial therapy is non-inferior to a conventional~     14-days course of intravenous therapy regarding efficacy and safety. An early switch from~     intravenous to oral therapy would provide several benefits such as earlier discharge, fewer~     adverse reactions associated with intravenous therapy, increased quality of life, and cost~     savings.~   "
135568|NCT01792791|"~     Arthritis is the nation's most common cause of disability. An estimated 50 million U.S.~     adults (about 1 in 5) report doctor-diagnosed arthritis. Twenty three million U.S. adults of~     working age (18-64 years) have arthritis; and in this age group arthritis-attributable work~     limitations affect about 1 in 3 people. An estimated 12% of all patients seeking intervention~     for symptomatic arthritis have an etiology of previous trauma to the involved joint.~      The purpose of this study is to examine these inflammatory compounds in the joint fluid~     (synovial fluid), the joint lining (synovium), and in blood among subjects with isolated~     intra-articular fractures.~      The hypothesis is that early levels of intra-articular inflammation and markers of joint~     tissue degeneration following articular fracture in the human knee are predictive of the~     development of PTA (Post Traumatic Arthritis). Early levels of intra-articular inflammation~     and markers of joint tissue degeneration identified from human knee joints following~     articular injury are predictive of the development of PTA in the mouse knee.~      Samples of blood, urine and synovial fluid will be taken at the spanning frame surgery and~     only synovial fluid at the ORIF (Open Reduction Internal Fixation)surgery. Two MRIs (Magnetic~     Resonance Imaging) will be part of this study at 4 weeks and 18 months.Participants will~     complete a set of questionnaires(KOOS: Knee Injury and Osteoarthritis Outcome Score) at 4~     weeks and 18 months.~   "
135569|NCT01792778|"~     The purpose of this pilot study is to collect the necessary information for determining the~     appropriate sample size of a statistically powered trial comparing the performance of two~     different blood control peripheral intravenous catheters.~   "
135622|NCT01792063|"~     In our study we aim to study the effects of two preparations of Sevoflurane in vital capacity~     rapid inhalation induction.~   "
135571|NCT01792752|"~     The overall goal of this project is to implement and evaluate a community-level, structured~     approach to enhance HIV care access and retention for drug users in San Juan, Puerto Rico.~     The Enhanced HIV Care Access and Retention Intervention will: 1) identify drug users living~     with HIV who either do not know their HIV status and/or are not engaged in HIV care; 2)~     provide direct HIV care services through a mobile health van; and 3) support identified~     HIV-infected drug users with patient navigators to enhance their ability to engage in HIV~     care and substance abuse treatment, to initiate antiretroviral therapy, and maintain~     adherence to their treatment regimens. The structural enhanced care approach will be~     evaluated through a randomized roll-out design, a refinement of the stepped-wedge design. The~     community-level success of the intervention will be assessed by evaluating virologic~     suppression (primary biological outcome), increased attendance to HIV care visits, uptake of~     antiretroviral therapy, adherence to HIV treatment regimens, and decreased substance use (as~     secondary behavioral outcomes) in an independent cohort of HIV-positive individuals drawn~     from each of the neighborhoods included in the intervention. We will also evaluate the~     implementation process and cost of the enhanced care approach including implications for~     cost-effectiveness, feasibility of expansion, and sustainability.~   "
135572|NCT01792739|"~     The purpose of this trial is to clarify the impact of lactobacillus preparation on the~     incidence of diarrhea in ICU-admitted patients.~      Almost all patients in ICU are treated with antibiotics for the effective control of various~     infections. However, antibiotics-associated diarrhea is another matter of concern. Many~     previous studies were proved that the use of probiotic lactobacillus preparation can reduce~     antibiotics-associated diarrhea in ward-admitted patients. In this study, we are planning to~     perform a similar study in severely ill patients in ICU.~   "
135573|NCT01792726|"~     TARGIT-Boost is an international randomised clinical trial designed to test the hypothesis~     that the tumour bed boost delivered as a single dose of targeted intraoperative radiotherapy~     (TARGIT-B) is superior to the conventional course of external beam radiotherapy boost~     (EBRT-Boost), especially in women with high risk of local recurrence. It is a pragmatic trial~     in which each participating centre can use the local predefined inclusion/exclusion criteria~     for entry into the trial. Only centres with access to the Intrabeam® (Carl Zeiss) are~     eligible to enter patients into the trial.~      Eligible patients are those with a higher risk of local recurrence after breast conserving~     surgery.~      After giving consent patients are randomised to either TARGIT Boost or EBRT Boost. All~     patients will receive whole breast EBRT. They may receive any other adjuvant treatments as~     deemed necessary. The protocol recommends that patients be followed at six monthly intervals~     for three years and then annually.~      The primary endpoint is ipsilateral breast recurrence rate. Secondary endpoints are~     relapse-free survival, site of recurrence, overall survival (breast-cancer specific and~     non-breast cancer deaths) patient satisfaction and quality of life.~   "
135574|NCT01792713|"~     Investigation aimed to explore the efficacy of a topical Sertaconazole cream 2% in patients~     with skin alterations associated with atopic dermatitis~   "
135575|NCT01792700|"~     patients who had failed previous H. pylori eradication on standard triple therapy were~     randomized into two regimens: 1, esomeprazole (20 mg b.i.d), tripotassium dicitrate~     bismuthate (300 mg q.i.d), metronidazole (500 mg t.i.d), and tetracycline (500 mg q.i.d)~     (EBMT) or 2, moxifloxacin (400 mg q.d.), esomeprazole (20 mg b.i.d), and amoxicillin (1000 mg~     b.i.d.) (MEA). At four weeks after completion of eradication therapy, H. pylori tests were~     performed with 13C urea breath test (UBT) or invasive tests (Giemsa histology, CLO test, and~     culture). In patients who maintained continuous H. pylori negativity for the first year after~     eradication therapy, H. pylori status was assessed every year. For the evaluation of risk~     factors of reinfection, gender, age, clinical diagnosis, histological atrophic gastritis or~     intestinal metaplasia were analyzed.~   "
135576|NCT01792687|"~     This is a Phase Ib, open label study of ARN-509 administered in combination with abiraterone~     acetate and prednisone in patients with metastatic castration-resistant prostate cancer.~   "
135577|NCT01792674|"~     Care for pregnant is a field where unexpected emergencies occur, however emergencies are rare~     and hence competences difficult to learn. Therefore, it can be relevant to use~     simulation-based medical education. Many questions on how simulation can optimise learning~     remain unanswered. A major question is how simulation settings as 'in situ simulation' (i.e.~     in the actual patient care unit) versus 'off site simulation' (i.e. in training rooms or~     simulation center) impact learning.~      Objectives: To study the effect of 'in situ simulation' versus 'off site simulation' on~     learning outcome, safety-attitudes, team performance and clinical performance in the~     simulated setting plus stress and motivational inducing effect of simulation settings.~      Design: Randomised trial. Primary outcome: Written knowledge-test. Exploratory outcomes:~     Safety Attitudes Questionnaire, team- and clinical performance score, validated stress~     inventory, salivary cortisol, Intrinsic Motivation Inventory and questionnaire on perceptions~     of the simulation and organisational changes needed.~      Perspective: To provide new knowledge on contextual effects of different simulation settings.~   "
135588|NCT01792531|"~     Obesity has been shown to be resistant to treatment in adults, adolescents, and in school age~     children, but not during early childhood. Yet knowledge on the effectiveness of early~     childhood treatment programs for obesity is still very limited, preventing the widespread~     implementation of such programs. The overarching purpose of this study is to evaluate the~     effectiveness of early treatment of childhood obesity. The investigators plan to perform a~     carefully-designed randomized controlled trial that will evaluate different treatment options~     offered to families with children with obesity, organized within the healthcare system and~     followed up for at least 1 year post-baseline. Participants will be children aged 4-6 years~     (N=180) with obesity and their parents. This study will facilitate a close examination of key~     treatment components and mechanisms of change. Results from this study will lead to better~     healthcare options for obesity treatment during childhood and ultimately to the prevention of~     obesity later in life from a public health perspective.~   "
135589|NCT01792518|"~     Evaluate linagliptin in terms of glycemic control as defined by HbA1c after 24 weeks of~     treatment and in terms of renal efficacy as defined by changes in albuminuria (UACR) after 24~     weeks of treatment.~   "
135623|NCT01792050|"~     The purpose of this study is to compare the effects, good and/or bad, of standard of care~     therapy (docetaxel or paclitaxel) with or without the addition of 1-Methyl-D-tryptophan~     (referred to as indoximod) an experimental drug to find out which treatment is better.~   "
135578|NCT01792661|"~     The study's purpose is to address the challenges of providing stage-appropriate chronic~     kidney disease (CKD) education and care by developing innovative programs using a CKD Patient~     Navigator system and an EHR (electronic health record)-based enhanced electronic~     communication system specific for a CKD patient and her/his physicians/caregivers. The~     investigators plan a randomized controlled trial of these innovations to examine the utility~     and effectiveness of these special interventions.~      The investigators' CKD registry aids in identifying patients for recruitment for the~     randomized control trial. Patients are randomized into one of four groups. The four groups~     are: 1) the control group using MyChart; 2) an enhanced personal health record (PHR) included~     in MyChart consisting of 35 websites chosen to disseminate CKD stage-specific goals of care~     and CKD education; 3) the patient navigator, a lay professional trained in the specifics of~     chronic kidney disease navigation with a focus on the needs of their patients based on the~     National Kidney Foundation Disease Outcomes Quality Initiative; 4) the patient navigator~     combined with the enhanced MyChart.~      The investigators hypothesize that a CKD Patient Navigator program will develop a more~     prepared, proactive patient-caregiver team than usual care; the enhanced PHR will produce a~     more informed, engaged patient than usual care; the CKD Patient Navigator arm and enhanced~     PHR will demonstrate a slower rate of decline in eGFR (glomerular filtration rate) than usual~     care.~      The results of this study will lay the foundation for a larger multi-center national clinical~     trial that will build upon the feasibility and knowledge gained from this planning grant.~   "
135579|NCT01792648|"~     Increased abdominal adiposity is a key feature of metabolic syndrome, which describes a~     cluster of cardiovascular disease (CVD) risk factors that also includes insulin resistance,~     high blood pressure and an atherogenic lipoprotein phenotype characterized by increased~     plasma triglycerides, low HDL-C, and increased levels of small LDL particles. While lifestyle~     intervention remains the cornerstone for managing obesity and metabolic syndrome, the optimal~     dietary macronutrient distribution for improving blood lipids and CVD risk remains a topic of~     controversy. While both low carbohydrate diets and weight reduction are effective for~     managing atherogenic dyslipidemia, long-term compliance is low, and it becomes imperative to~     identify alternative dietary approaches.~      Increased consumption of almonds has been shown to lower LDL-C, an effect that exceeds that~     predicted from changes in fatty acid intake. However, although LDL-C lowering by almonds has~     been demonstrated in patients with diabetes, there have been no trials in non-diabetic~     patients with abdominal obesity. Moreover, there is limited information of the effects of~     almond intake on LDL particle subclasses.~      The overall objective of the present study is to determine whether lipoprotein measures of~     CVD risk in individuals with increased abdominal adiposity are reduced by almond~     supplementation in a diet with overall macronutrient content that conforms to current~     guidelines. Our main hypothesis is that in these individuals, almond consumption can reduce~     levels of small and medium LDL particles without the need to restrict dietary carbohydrates~     to levels below those currently recommended.~      This hypothesis will be tested by comparing the lipoprotein effects of an almond-supplemented~     diet (20%E) with those of two reference diets that do not contain almond products: one with~     similar content of carbohydrate, protein, and fat (standard reference), and the other in~     which carbohydrate content is reduced by substitution of protein and monounsaturated fat~     (low-carbohydrate reference).~      We will provide the diets for 3 weeks each in a randomized 3-period crossover design to 40~     individuals with increased abdominal adiposity. We will test whether the almond supplemented~     diet will result in lower levels of lipoprotein measures of CVD risk, specifically LDL-C and~     small and medium LDL particles, compared to either the standard or low-carbohydrate reference~     diets.~   "
135580|NCT01792635|"~     This study is designed to assess the safety, tolerability and pharmacodynamics of 6 weeks of~     oral doses of PF-05175157 provided as monotherapy in subjects with type 2 diabetes mellitus.~   "
135581|NCT01792622|"~     Develop a brief, new, patient reported outcome instrument that is valid for use in clinical~     practice and clinical trials.~   "
135582|NCT01792609|"~     Objectives Primary objective: Determine if there is a clinically significant difference in~     percent Cobb curve correction in a low- vs. high-implant density cohort through a prospective~     randomized controlled trial.~      Design and Outcomes Randomized clinical trial of equivalence to test the efficacy and safety~     of low vs. high implant density instrumentation for spine deformity surgery in AIS patients~     with Lenke IA curve patterns.~      Interventions and Duration Intervention: low-implant density group or high-implant density~     group. Duration: 2 years. Sample Size and Population Target population: 10 to 17 years old~     with AIS who will undergo instrumented spinal fusion. Sample size needed (power = 90%) is 174~     subjects with 87 in each group.~   "
135583|NCT01792596|"~     The combination of fiber and protein added to pasta will enhance satiety.~   "
135584|NCT01792583|"~     The primary objective of the Nuvigil/Provigil Pregnancy Registry is to characterize the~     pregnancy and fetal outcomes associated with Nuvigil and Provigil exposure during pregnancy.~   "
135585|NCT01792570|"~     Clinical approach to HIV infection treatment is based on the use of highly active~     antiretroviral therapies (HAART) and recent national and international guidelines for guiding~     HIV therapy recommend the use of triple-combination therapy using antiretrovirals with 2~     nucleos(t)ide inhibitors [N(n)RTI] as backbone plus a third drug to be chosen among a boosted~     protease inhibitor (PI/r), a nonnucleoside inhibitor (NNRTI) or an integrase inhibitor (II).~      In spite of evident efficacy of HAART, as demonstrated by survival increasing, long term side~     effects, as for example the impact on renal function, remain principal problem.~      In patient with risk factor for renal disease, a reduction of eGRF (estimated Glomerular~     Filtration Rate) between 90 and 60 mL/min/1,73 m2 could be already considered as a risk~     condition [1,2].~      Efficacy of HAART, with increase of media survival and the parallel decrease of mortality,~     has underlined the necessity to reflect on long term HAART effects [3].~      There are many evidences of HAART-related toxicity that, in spite of the necessity of a~     life-saving therapy, focus on the additional costs of this situation, in terms of health as~     well as in terms of economic costs.~      Particular attention has been focused on the impact of some drugs on renal function, as~     tenofovir, especially on tubule, without forgetting the modification of lipid and bone~     metabolisms.~      According to further studies which have evidenced the potential of some recently introduced~     molecules [4,5], the investigators had the need to realize a study to deepen the feasibility~     of a dual-therapy that permit to exclude NRTIs from the backbone, with the aim to prevent~     NRTIs-related long-term toxicity.~      The investigators have designed a prospective randomized controlled trial, open-label, with a~     duration of 96 weeks, to compare the efficacy of a dual-therapy based on rilpivirine 25mg~     plus darunavir 800mg/ritonavir 100mg QD, in HIV-positive subjects with suppressed viremia~     from at least 3 months. In fact, there are a few data about association of these drugs, which~     it has been shown to be safe, well tolerated, and with a strong pharmacological synergy,~     without nucleos(t)idic backbone, while the necessity to minimize the costs toxicity-related~     is becoming increasingly compelling.~      According to clinical experience and literature data, the investigators hope this study shows~     positive results in term of immune-virological efficacy, as well as in term of decrease of~     VACS index - a complex parameter which has the purpose to quantify general organic decay -~     and markers of lipid and bone metabolism, in group which receives dual-therapy versus the~     group with standard therapy.~   "
135586|NCT01792557|"~     Although surgical techniques such as limberg flap. modified limberg flap and karydakis are~     currently most popular treatment methods for pilonidal disease, crystallized phenol~     application is also successfully used for pilonidal sinus treatment by different centers. We~     believe crystallized phenol application could become a good alternative to popular surgical~     interventions using transposition flaps.~   "
135587|NCT01792544|"~     This study examines the impact of adding a statement to the echocardiography report that~     advises anyone reading the report regarding if and when a follow-up study is recommended.~   "
135624|NCT01792037|"~     we aim to evaluate the effects of single dose of etomidate or use of steroid prior to~     etomidate during emergency intubation on hemodynamics and adrenal cortex.~   "
135590|NCT01792505|"~     Malignant gliomas are very aggressive and among the most common of brain tumors. A diagnosis~     carries with it a median survival of approximately 24 months. The current standard treatment~     of surgical resection followed by radiation therapy and chemotherapy has not substantially~     prolonged survival and even the few treatment options shown to exhibit small increases in~     survival primarily benefit certain (i.e., young) patient subpopulations.~      Cancer vaccines represent one novel therapy for malignant gliomas. The goal is for the body~     to recognize the tumor cells are foreign and produce its own response to fight off recurring~     tumor cells. A promising means of causing an immune response so the body can create this~     immunity is through the use of dendritic cell (DC) vaccines.~   "
135591|NCT01792492|"~     This study will investigate the usefulness of an optical probe in the differentiation of~     thyroid cancer from normal thyroid tissue in a thyroidectomy specimen.~   "
135592|NCT01792479|"~     The purpose of this study is to evaluate the efficacy and safety of BIND-014 in patients with~     advanced non-small cell lung cancer (NSCLC).~   "
135593|NCT01792466|"~     Endoscopic cholangiography is a procedure which is performed to image the bile duct and~     perform therapy like removal of bile duct stones. It is currently standard of care to remove~     stones from the bile duct when found as they frequently cause complications like infections~     which can sometime be life threatening.~      Therapy on the biliary tree, like for example stone removal, frequently requires inserting~     tools through the opening of the duct and cutting of the muscle which control the secretion~     of juices from the liver. Cutting the muscle helps with securing an easy access to the bile~     duct. It also helps facilitating dragging the stones out. On certain occasions placing a wire~     in the bile duct fails and instead the wire keeps entering the pancreatic duct whose opening~     is adjacent to the bile duct opening. There is evidence to suggest that keeping a wire in the~     pancreatic duct facilitates placing a second wire in the bile duct possibly because it~     straightens the duct. On certain occasions this also fails and we resort to cutting the~     muscle of the pancreas and the bile duct simultaneously to facilitate the access to the bile~     duct. The more attempt to enter the bile duct the higher the risk of inflammation in the~     pancreas known as pancreatitis. This makes decreasing the number of attempts at placing the~     wire in the duct desirable. One way to facilitate placement of the wire in the bile duct is~     to cut starting from the opening of the pancreas duct aiming toward the bile duct muscle.~     This often cuts the bile duct sphincter and exposes the bile duct opening. The study is~     trying to answer if cutting the bile duct sphincter muscle in the direction of the bile duct~     immediately after a wire has entered the pancreatic duct will make it easier to place the~     wire in the bile duct as compared to trying to place the wire in the bile duct without~     cutting the opening. While cutting the muscle canincrease the risk of pancreatitis, repeated~     attempts at accessing the bile duct can also increase the risk of pancreatitis. So if cutting~     the pancreatic muscle will facilitate entry to the bile duct and decrease the number of~     attempts at entering the bile duct then it might be a better way to approach the patient whom~     we had difficulty in entering the bile duct.~   "
135594|NCT01792453|"~     The GI MRI Research group at the University of Nottingham has been developing new,~     non-invasive magnetic resonance imaging (MRI) techniques to image the gastrointestinal tract.~     The investigators now want to characterise; in collaboration with the College of Pharmacy at~     the University of Michigan, the fasting volumes of gastric and small bowel liquid and their~     time courses over 2 hours after drinking the FDA recommended 240 mL of water drink for oral~     solid dosage forms testing.~   "
135595|NCT01792440|"~     Non-cystic fibrosis bronchiectasis patients (and controls) were recruited for the study. The~     investigators' aim was to study the relevance of clinical parameters in terms of underlying~     disease severity, proteolysis and inflammation in a diverse non-cystic fibrosis~     bronchiectasis population.~   "
135596|NCT01792427|"~     In this study we analyzed the overall survival for all newly diagnosed patients with~     non-cystic fibrosis bronchiectasis from June 2006 onwards. The investigators wanted to~     confirm the known risk factors such as age, gender, smoking history and Pseudomonas~     aeruginosa and evaluate the impact on survival of etiology, number of different~     bacteriological species in retrospective and prospective sputa, azithromycin use and~     presence/development of pulmonary hypertension.~   "
135597|NCT01792414|"~     This study is a RCT of transcranial electrical stimulation in depressed patients. Mood,~     cognitive test performance and biomarkers will be measured during the trial.~   "
135598|NCT01792401|"~     The purpose of this study is to investigate the effect of probiotics in enteral nutrition on~     improving gut function, inflammatory markers and clinical outcomes in critically ill patients~     admitted to the intensive care unit.~   "
135599|NCT01792388|"~     Increased Intestinal Permeability is detectable in clinically active Crohn's disease, in~     stable Crohn's disease and is predictive of clinical relapse. Maintenance of the epithelial~     barrier integrity is therefore essential for intestinal homeostasis. Vitamin D may have a~     critical role in improving barrier function.~   "
135600|NCT01792375|"~     To compare concurrent membrane sweeping with dinoprostone versus dinoprostone in labor~     induction for nulliparas at term with an unfavorable cervix~   "
135601|NCT01792362|"~     This study is a prospective before & after clinical trial to compare the basal and 3 months~     after diet anti-mullerian hormone levels between responders and non-responders to weight loss~     diet in obese infertile women with PCOS population~   "
135602|NCT01792349|"~     There is good evidence of the effectiveness of regular physical activity in the primary and~     secondary prevention of stroke. STARFISH is a smartphone-based application designed as a~     behavioural change intervention to encourage the user to become more physically active. The~     study will investigate if using STARFISH for 6 weeks can increase physical activity in people~     after stroke. Subjects will be randomised to the STARFISH intervention or a control group.~     Control subjects will not have access to their daily activity count.~   "
135603|NCT01792336|"~     Background:~        -  The brain has natural electrical rhythms of brain activities. These rhythms may be~          different in people with movement disorders, such as dystonia (involuntary muscle~          movement, cramps, or tremors). Understanding these rhythms may provide more information~          about movement disorders.~        -  Focal hand dystonia, also known as writer's cramp or musician's cramp, is a painful~          condition that affects the hand and arm muscles. Researchers want to use transcranial~          magnetic stimulation (TMS) to study brain rhythms in people with and without focal hand~          dystonia.~      Objectives:~      - To better understand brain rhythms involved in focal hand dystonia.~      Eligibility:~        -  Individuals between 18 and 70 years of age who are right-handed and have focal hand~          dystonia.~        -  Healthy right-handed volunteers between 18 and 60 years of age.~      Design:~        -  Participants will be screened with a physical exam and medical history.~        -  This study includes two tests: a pilot test and a main test. The pilot test will~          determine the frequency of TMS that will be used in the main test. Participants may be~          in one or both tests. Each test requires a single outpatient visit that will last up to~          5 hours.~        -  Participants will have a base test to see how their muscles respond to TMS. This will~          look at the electrical activity of the muscles. Participants will have a wire coil held~          on their scalp. A brief electrical current will pass through the coil. It creates a~          magnetic pulse that stimulates the brain. Researchers will test the TMS on the right and~          left sides of the head. This will help find the spot that activates the finger muscles,~          and see how much TMS is needed.~        -  In the main test, participants will have repetitive TMS (rTMS). rTMS involves repeated~          magnetic pulses delivered in short bursts. There will be four pulses in each burst.~          Participants will have multiple bursts during the test. This test will look at how the~          muscles of the hand and fingers respond to brain stimulation.~        -  Treatment for focal hand dystonia will not be provided as part of this study.~   "
135625|NCT01792024|"~     This phase II trial studies how well magnetic resonance (MR)-guided laser interstitial~     thermal therapy works in treating patients with prostate cancer. Laser therapy uses intense,~     narrow beams of light to cut and destroy tissue and may help treat prostate cancer~   "
135626|NCT01792011|"~     The aim of this study is to compare the accuracy of PVI (pleth variability index)~   "
135604|NCT01792323|"~     To cover meal-related insulin requirements, insulin pumps allow insulin to be delivered at~     high rates over a short period of time (bolus delivery). The length of this period (bolus~     duration) usually depends on the chosen bolus size and on the used insulin pump model. This~     study will evaluate the impact of different bolus durations (i.e., durations commonly~     employed in commercially available insulin pumps: 2 and 40 seconds for delivering 1 Unit of~     insulin) on the pharmacokinetic and pharmacodynamic properties of an rapid-acting insulin~     analogue.~      Objective: To evaluate in type 1 diabetic patients the pharmacodynamics and pharmacokinetics~     of rapid-acting insulin (insulin lispro) administered as subcutaneous boluses with different~     bolus durations.~      Study design: Single-center, randomized, controlled, two-arm cross-over intervention study~      Population: Twenty type 1 diabetic subjects~      Intervention: The investigational treatment is the subcutaneous administration of insulin~     lispro either as one bolus of 15 IU over a period of 30s or as one bolus of 15 IU over a~     period of 10 min. Plasma samples to assess pharmacodynamic and pharmacokinetic properties~     will be taken during an 8-hour clamp experiment. Patients will undergo both investigational~     treatments in a randomized order; between the two clamp visits there will be a wash-out~     period of 5-21 days.~      Main study endpoint: Time to maximum glucose infusion rate~   "
135605|NCT01792310|"~     This is a phase 1/2A, open label, non-randomized study in patients with advanced solid~     tumours including malignant glioma~   "
135606|NCT01792297|"~     Bovine colostrum is the initial milk secreted by cows during the first day after calving.~     Colostrum is high in protein and contains a number of substances that have potential to be~     beneficial for the immune system. Preliminary studies about effects of colostrum~     supplementation show its potential for increasing human exercise performance; however, more~     evidence across the lifespan is required to confirm effects and to understand mechanisms of~     action. The objectives are to determine the effect of 8 weeks of bovine colostrum~     supplementation, compared to whey protein supplementation on the following dependent~     variables in men and women 50 years and older while participating in a resistance-training~     program:~        -  muscle mass~        -  strength~        -  blood levels of growth factors and markers of inflammation~        -  urine levels of muscle and bone catabolic markers~        -  tests of cognitive ability It is hypothesized that bovine colostrum supplementation will~          result in greater increases in muscle mass, strength, blood IGF-1 levels (an anabolic~          hormone), and cognitive ability, and greater reductions in inflammation, and markers of~          muscle and bone catabolism, compared to placebo.~   "
135607|NCT01792284|"~     The primary purpose of participation in this study is to compare the safety and efficacy of~     different dosing schedules of LY2605541 and how different dosing schedules of LY2605541~     affect Hemoglobin A1c (HbA1c). Participants will be treated for up to 36 weeks with LY2605541~     (one 12-week Lead-in period and two 12-week Randomization periods) and will participate in a~     total of 42 weeks of total study enrollment, including a 2-week Screening period and a 4-week~     Follow-up period.~   "
135608|NCT01792271|"~     The purpose of this research study is to examine the effects of two weeks of daily dosing of~     inhaled salt water mist (hypertonic saline - HS) on actual measurements of mucociliary and~     cough clearance in patients with the chronic bronchitis type of Chronic Obstructive Pulmonary~     Disease (COPD.~      Defective mucociliary clearance (MCC) is central to the development and/or worsening of~     several kinds of lung diseases, including COPD/chronic bronchitis (CB), cystic fibrosis (CF),~     and bronchiectasis. In each case, defective MCC leads to the development of lung infections~     and damage to the airways from ongoing inflammation caused by a person's inability to clear~     mucus from the lungs.~      The investigators' previous studies have shown that the administration of inhaled HS~     (hypertonic saline) not only acutely accelerates MCC in CF, but also that repetitive use~     resets the baseline rate of MCC within 2 weeks. It is likely that the sustained effect of~     HS on MCC was responsible for the ~60% reduction in the frequency of pulmonary disease~     exacerbations, reduced antibiotic use and improved lung function in a long-term study of HS~     in CF volunteers. As a result, HS has now become a standard therapy for CF lung disease and~     its success raises optimism that similar benefits might occur in patients with CB.~      In this study the investigators will use mildly radioactive particles, technetium bound to~     sulfur colloid, to measure and compare the sustained effects on mucus clearance of two weeks~     of daily dosing of 7% hypertonic saline versus a low salt control treatment for subjects with~     CB. We will also be collecting sputum and breath condensation to analyze for protein and~     inflammatory changes that might occur with exacerbations.~      Our long term goals are to improve our understanding of MCC in health and disease and to~     develop better therapies that support and/or restore MCC in patients with these diseases to~     reduce lung infections.~   "
135609|NCT01792258|"~     Tracheostomy is worldwide performed in Intensive Care Unit (ICU). According to the current~     literature, indication for percutaneous tracheostomy (PDT) in ICU are: difficult prolonged~     weaning, prolonged mechanical ventilation, loss of airway reflex, copious secretions, upper~     airway obstruction. Many studies have focused on the comparison between different PDT~     techniques and complication. The aim of our study is to evaluate the procedural features,~     complications, ICU mortality, quality of life, post-discharge mortality of patients~     undergoing different PDT techniques performed in ICU.~   "
135610|NCT01792245|"~     Hand psoriasis/eczema is a common problem which is characterized by itchy, erythematous and~     scaly lesions often with a long lasting and relapsing course. Treatment is difficult with~     considerable number of patients do not or only partially respond to the current treatments.~     Several studies have shown the therapeutic effectiveness of the combination of topical~     psoralen with long wavelength ultraviolet A radiation (PUVA) in treating hand~     psoriasis/eczema. Topical PUVA is has several short- and long-term side effects. Narrow band~     ultraviolet B (NB-UVB) has emerged recently as an important treatment for a variety of~     photoresponsive diseases including psoriasis and eczema. For most conditions (other than hand~     psoriasis/eczema) NB-UVB has been shown to have similar therapeutic results to PUVA with less~     side effects. There are only a few studies published on the efficacy of NB-UVB for hand~     psoriasis/eczema. Therefore, this study is aimed at comparing the efficacy and safety of~     t-PUVA and NB-UVB in treating these conditions.~   "
135611|NCT01792232|"~     The investigators are investigating the effects of combined exposures to diesel exhaust and~     allergens on lung function and on the immune system. After exposing individuals to either~     filtered air or carefully controlled levels of diesel exhaust in our exposure chamber, The~     investigators will use a procedure called bronchoscopy (whereby a thin, flexible tube is~     passed down the throat and into the lungs) to place a small amount of allergen directly in~     the lung. 48h later, the bronchoscopy will be repeated so that samples can be collected from~     the lungs. After 1mo, the entire procedure will be repeated with the alternate exposure.~   "
137429|NCT01768403|"~     Centralized Pan-Algerian Survey on the undertreatment of hypercholesterolemia. The purpose of~     this study is to establish the proportion of patients on lipid-lowering pharmacological~     treatment reaching the LDL-C goals according to the Third Joint European Task Force~     guidelines in the survey population.~   "
135612|NCT01792219|"~     Title: The effectiveness of learning to collaborate interprofessionally on healthcare~     processes and outcomes in nursing homes: a cluster randomized controlled trial in primary~     care.~      The ageing of the population is expected to be a major driver of increasing demand for more~     complex and continuous care. The delivery of health care for this population requires high~     level of coordinated teamwork and efforts. Interprofessional collaboration can improve~     healthcare processes and outcomes. It assumes a model of working together. It is a process by~     which professionals develop an integrated and cohesive answer to the needs of the patients.~     In this study the possible effects of learning to interprofessionally collaborate will be~     investigated on health care processes and outcomes for chronic geriatric patients in nursing~     homes.~   "
135613|NCT01792206|"~     The purpose of this research study is to study the effects of paricalcitol on endothelial~     function and inflammation, cardiovascular risk factors which are associated with patient~     populations that have Type 2 diabetes and Stage 3 and 4 Chronic Kidney Disease (CKD).~      Hypothesis 1: The state of CKD is associated with oxidative stress and inflammation and~     impaired post ischemic endothelium dependent flow mediated vasodilation which may contribute~     to atherogenesis.~      Hypothesis 2: The administration of paracalcitol to patients with CKD will suppress oxidative~     stress and inflammation and improve endothelial function and thus contribute to an~     anti-atherogenic action.~   "
135614|NCT01792193|"~     In previous work, the investigators analyzed the concentration of gut-derived peptides~     (ghrelin, pancreatic polypeptide [PP]) in serum of patients with Parkinson's disease (PD).~     The investigators have shown that the secretion pattern differs between PD patients and~     controls. Beside ghrelin and pancreatic polypeptide other gut-derived peptides (e.g.~     Glucagon-like-Peptide 1[GLP-1], Amylin, etc.) might be relevant for PD as well. The rational~     to investigate gut-derived peptides in the neurological disorder Parkinson's disease (PD) is~     based on the following considerations:~        -  Receptors for gut-derived peptides are expressed in Central Nervous System (CNS)~          structures that are affected by the neurodegenerative process underlying Parkinson's~          disease~        -  Gut-derived peptides are involved in the modulation of higher brain functions (mood,~          cognition, reward-related behaviour) that are frequently altered in Parkinson's disease.~        -  The secretion of gut peptides is (co-)regulated by the vagal nerve that is dysfunctional~          in Parkinson's disease.~        -  Certain gut-derived peptides (ghrelin, GLP-1) stimulate neurogenesis and might be able~          to prevent cell death in neurodegenerative disorders, including Parkinson's disease.~      Objective:~      Collection of CSF and serum samples in a standardized way in order to quantitatively measure~     the concentration of gut-derived peptides (ghrelin, leptin, glucose-dependent insulinotropic~     peptide [GIP], GLP-1, amylin, PP, peptide YY [PYY], and insulin). Scientific questions:~        1. Do CSF (and serum) concentrations of these gut peptides differ between PD patients and~          controls?~        2. Do CSF (and serum) concentrations of the investigated peptides correlate with clinical~          and / or epidemiological characteristics of the investigated subjects (age, gender, BMI,~          disease duration, severity of motor impairments, presence of non-motor symptoms,~          co-morbidities, medication, etc.)?~   "
135615|NCT01792180|"~     The Senior Step Study investigates whether feedback given by a mobility feedback device in~     combination with an instruction book containing every day exercises, motivates elderly to~     exercise more. By exercising more participants take charge of their own mobility and fall~     risk. Senior Step Study studies whether this 'exercising more' positively affects their~     mobility, fall risk, mental wellbeing, self-management, and quality of life.~   "
135616|NCT01792167|"~     This study is a large-scale, randomized longitudinal evaluation of Second Step: Student~     Success Through Prevention (Second Step - SSTP), a middle school intervention (Committee for~     Children, 2008), which targets the shared underlying risk and protective factors for~     bullying, sexual harassment, and dating aggression. This program is unique in its emphasis on~     the role of peer group norms, attitudes, and behavior in the initiation and maintenance of~     bullying and other forms of violence. Because of this, this investigation will involve a~     direct test via social network analysis the extent to which peer norms or shifts in peer~     attitudes are impacted by the intervention. Bullying is conceptualized as including verbal,~     physical, relational, and cyber-aggression. Sexual violence is conceptualized as including~     sexual harassment, sexual coercion in dating relationships, and homophobic teasing.~     Thirty-six schools were drawn from four school districts in Illinois and one large district~     in Wichita, Kansas and randomly assigned to Second Step - SSTP or a control condition. Second~     Step -SSTP program draws from the risk/protective factors model and social-cognitive theories~     of aggression. Lessons focus on the outcomes of bullying, relational aggression, sexual~     harassment, dating relationships, and substance use. Risk factors targeted include~     inappropriate classroom behavior, favorable attitudes toward aggression and substance abuse,~     deviant peer affiliation, peer rejection, and impulsiveness are targeted as risk factors.~     Targeted protective factors include empathy, problem-solving skills, school connectedness,~     assertiveness and adoption of conventional norms. The P3R: Stories of Us - Bullying program,~     composed of a series of film-based education will be used in the control schools. All 6th~     graders at each school will be recruited and followed for the three year study period.~     Students and teachers will complete self-report and nomination tasks. Growth curve analysis~     via hierarchical linear modeling (HLM; Bryk & Raudenbush, 1992) will be utilized to assess~     change in the major dependent variables (bullying, sexual harassment perpetration, dating~     aggression), structural equation modeling will test for mediators across the study period,~     and social network analysis will be instrumental in identifying peer norms and attitudes.~   "
135617|NCT01792154|"~     Assess changes in the corneal cell count using Specular Microscopy following tretments with~     Anti-VEGF injections~   "
135618|NCT01792141|"~     The use of Indocyanine green diagnostic dye will identify areas of vascular leakage which~     will provide more effective laser treatment by targeting these specific areas.~   "
135619|NCT01792115|"~     Background:~        -  Non-alcoholic fatty liver disease (NAFLD) is an excess accumulation of fat in the liver~          cells. It is associated with obesity, high blood pressure, high cholesterol, and~          diabetes. Some people with NAFLD only have excess fat in the liver. However, other~          people may develop a worse form of NAFLD with liver injury and scarring. This form,~          called non-alcoholic steatohepatitis (NASH), can lead to liver failure, liver cancer,~          and death. Not much is known about why some people develop NASH and others do not.~        -  Lifestyle changes such as diet, exercise, and weight loss can decrease the liver damage~          in NAFLD. Some studies show that vitamin E can also help treat NAFLD. The dose of~          vitamin E used in these studies is almost 40 times the recommended amount of vitamin E~          intake from food. It is unclear whether a lower dose could achieve the same effect.~          Researchers also want to study how vitamin E works at different doses to treat NAFLD.~      Objectives:~        -  To find out the most effective dose of vitamin E to treat NAFLD.~        -  To gain a better understanding of how NAFLD and NASH develop, and predict who will~          respond to treatment.~      Eligibility:~      - Individuals at least 18 years of age with suggestion of non-alcoholic fatty liver disease.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected.~        -  For the first 12 weeks of the study, participants will meet with a nutritionist. They~          will have personalized diet and exercise plans. Treatment will be monitored with diaries~          and questionnaires to fill out at home. Participants will also wear a pedometer to~          measure physical activity.~        -  After the 12-week period, participants will have a full physical examination with the~          following tests:~        -  Blood tests~        -  Glucose tolerance tests~        -  Imaging studies (DEXA scan and magnetic resonance imaging)~        -  Liver and fatty tissue biopsy~        -  Two weeks after the tests, participants will start vitamin E treatment. They will take~          up to two pills a day, taken with fat-containing foods.~        -  4 weeks after starting treatment they will have a repeat full evaluation with imaging~          tests, blood work, and liver and fat biopsies.~        -  Participants who are taking vitamin E will take it for up to 120 weeks. They will have~          monitoring visits every 8 to 12 weeks. At the end of 120 weeks, they will have another~          full evaluation, with imaging tests, blood work, and liver and fat biopsies.~   "
135620|NCT01792102|"~     This is a Phase 1/2, multicenter, open label, dose-escalation, nonrandomized study to~     evaluate the safety, pharmacodynamics, and efficacy of a 60-minute infusion of carfilzomib~     for patients with progressive multiple myeloma.~   "
135627|NCT01791998|"~     This pilot clinical trial studies magnetic resonance thermal image guided laser interstitial~     thermal therapy in treating patients with breast cancer. Magnetic resonance thermal image~     guided laser interstitial thermal therapy may be able to kill tumor cells by heating up the~     tumor cells without affecting the surrounding tissue~   "
135628|NCT01791985|"~     This study is looking at a new drug called AZD4547 which is being tested for the treatment of~     oestrogen receptor positive breast cancer. AZD4547 is a drug which specifically blocks~     proteins called fibroblast growth factor receptors (FGFR1) that are involved in the processes~     that help cancer cells to grow. These proteins may also be responsible for the development of~     resistance to hormonal therapies used to treat some breast cancers. AZD4547 is not yet~     approved for use in breast cancer and is therefore being used in this study as a research~     drug.~      The investigators will also test the theory that it is not necessary for high levels of FGFR1~     to be present in the body to see benefit from AZD4547. (Stage 1 only)~   "
135629|NCT01791972|"~     The primary objective of this study is to evaluate the efficacy of a single dose (2~     inhalations, 180 mcg total) of Albuterol SPIROMAX (90 mcg per inhalation) versus placebo in~     patients with EIB.~   "
135630|NCT01791959|"~     To study the effects of synbiotics supplement on lipid profile, liver enzymes, inflammatory~     factors and hepatic fibrosis in patients with Nonalcoholic Steatohepatitis (NASH), 50~     patients who referred to Gastrointestinal (GI) clinic with steatosis grade 1 or more will be~     randomly allocated to receive 2 protexin capsules or placebos for 7 months; both groups will~     be advised to adherence our diet and exercise program too. At the first and the end of the~     intervention, lipid profiles, liver enzymes, some inflammatory cytokines, and liver fibrosis~     will be assessed and compared between groups.~   "
135631|NCT01791946|"~     The primary objective of this study is to assess the effectiveness of an investigational~     binocular treatment in improving vision in strabismic amblyopes (i.e., patients with lazy~     eye, or poor vision in one eye due to a present or former eye misalignment). Patients will be~     randomized to receive the study treatment either before or after strabismus surgery (i.e.,~     corrective eye alignment surgery) or sham treatment before surgery. The study hypothesis is~     that there will be no significant change in vision in neither the pre nor post-surgery groups~     and no significant change in vision in neither the sham nor actual treatment groups.~   "
135632|NCT01791933|"~     The purpose of this study is to investigate the effect of CAM treatments consisting of herbal~     medicine, Chuna manual therapy, pharmacoacupuncture, acupuncture on lumbar and cervical spine~     pain patients due to spinal disease.~   "
135633|NCT01791920|"~     To compare the safety and efficacy of Botulax® with Botox® in the improvement of moderate to~     severe glabellar lines.~   "
135634|NCT01791907|"~     Type 1 diabetes (T1DM) is a chronic disease that affects approximately 10% of all diabetes~     patients in the world. Diabetes a serious disease in which life expectancy is reduced,~     largely due to increased mortality from kidney disease and cardiovascular (CVD) disease. Poor~     glycemic control also results in eye and nerve damage, and psychosocial stress. Good~     metabolic control, e.g. normalized hemoglobin levels (HbA1c) and normal blood lipids, reduces~     the risk of eye, kidney, nerve, and vascular damage. Proper nutrition can normalize blood~     sugar levels, improve blood lipids and prolong life in people with diabetes, according to~     Swedish Council on Health Technology Assessment (SBU).~      Dietary treatment is therefore seen as pivotal in the treatment of diabetes. This project~     aims to evaluate two methods of structured training in patients with type 1 diabetes:~        1. A structured education in carbohydrate counting, a course inspired by the DAFNE program~          (Dose Adjustment For Normal Eating)~        2. A new, structured education for heart healthy food choices and low glycemic index in~          type 1 diabetes. The education is called My Wellness-LADDER (Lifelong Adult Diet &~          Diabetes Education Resource) and it is specifically designed to provide high long-term~          adherence through improved empowerment and transformative life style change.~      The methods are compared with regular routine (control group).~      This is a randomized controlled trial with three intervention groups 1) Healthy food choices~     with a low glycemic index, 2) carbohydrate counting, and 3) regular routine. Follow‐up period~     is 1 year. Eight Swedish specialist clinics are participating and 24 patients at each clinic~     are to be enrolled.~      The hypotheses is that structured group education on heart healthy food choices and low~     glycemic index provide the same improvement in glycemic control and quality of life as~     advanced carbohydrate counting in T1DM, as compared to regular routine. An additional~     hypotheses is that structured education on healthy food choices and low glycemic index leads~     to larger CVD risk factor reductions in T1DM compared to carbohydrate counting and regular~     routine and that structured education on healthy food choices and low glycemic index lead to~     more heart healthy food choices in T1DM compared to carbohydrate counting and regular~     routine. Lastly, the hypotheses is that structured education on healthy food choices and low~     glycemic index lead is more cost effective in T1DM compared to carbohydrate counting and~     regular routine.~   "
135635|NCT01791894|"~     This pilot clinical trial studies arsenic trioxide in treating patients with basal cell~     carcinoma. Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to~     stop the growth of tumor cells, either by killing the cells or by stop them from dividing~   "
135636|NCT01791881|"~     To compare the efficacy and safety of Hugel-Tox (Botulinum toxin A, Hugel, Korea) against~     Botox in the treatment of Essential Blepharospasm and to get a regulatory approval from KFDA~   "
135637|NCT01791868|"~     Study Hypothesis Generalized Convulsive Status Epilepticus (GCSE) is a medical emergency~     associated with an increased morbidity and a prolonged length of hospital stay. Only 50% of~     patients are discharged from the hospital within the first month after GCSE. Recent~     Guidelines from Experts highlight the necessity to improve the efficiency of the first line~     anti-epileptic (AE) therapy.~      Intravenous Sodium Valproate (SV) might be an adjuvant AE drug to the recommended first line~     AEs. Intravenous SV is available, well tolerated and easily injectible but also has~     pharmacologic properties for reducing the risk of seizures relapses and for being~     neuroprotective. However, efficacy of intravenous as an adjuvant therapy in GCSE has never~     been properly assessed.~      Primary Purpose The primary purpose is to assess if the association of intravenous Sodium~     Valproate with the recommended treatment for Generalized Convulsive Status Epilepticus~     increases to 20 % the number of living patients, discharged from the hospital at day 15.~   "
135638|NCT01791855|"~     Patients with renal impairment are the target population for PF-04634817. The clearance~     mechanism of this drug means that exposure may be increased in subjects with renal~     impairment. This study will investigate the effect of the drug in subjects with varying~     degrees of renal impairment. Pharmacokinetics, safety and toleration will be assessed.~   "
135639|NCT01791842|"~     Bone pain due to fibrous dysplasia of bone is usually treated with bisphosphonates. A small~     proportion of patients fail to respond adequately. Mutated bone cells produce large amounts~     of Interleukin-6 (IL-6), with increased bone resorption as a result. Inhibition of IL-6 may~     be of interest to reduce bone resorption and therefore bone pain. TOCIDYS is a~     placebo-controlled randomized cross-over trial to test the hypothesis that tocilizumab can~     reduce bone resorption in those patients with fibrous dysplasia who have already received~     bisphosphonates.~   "
135640|NCT01791829|"~     This is a multicentre, single-arm prospective cohort study evaluating risk of ipsilateral~     breast tumour recurrence(IBTR) following breast conserving surgery (BCS) in a group of women~     postulated to be at low risk for recurrence. Women with luminal A breast cancer determined by~     immunohistochemical(IHC) and other low risk clinical testing (see below) will be treated with~     endocrine therapy (tamoxifen or aromatase inhibitor) for five years and will not be treated~     with breast irradiation (BI). Subjects will be followed for 10 years and will be assessed for~     recurrent disease, new primary cancer and survival.~   "
135641|NCT01791816|"~     Vasovagal Syncope (simple postural faint) is the most common cause of acute loss of~     consciousness. Postural tachycardia syndrome(POTS) is the most common chronic form of~     postural lightheadedness. Together they afflict many Americans, mostly young women, who are~     prevented from gainful employ or school attendance. The underlying mechanism is not known.~     Our past work suggests that a simple molecule, nitric oxide, acts to subvert normal blood~     flow controls causing blood to pool in the gut when standing. Our proposal will show the~     mechanism behind this problem and will indicate effective medical treatments. Patients will~     be compared to healthy control subjects.~   "
135642|NCT01791803|"~     Smoking-related cardiopulmonary diseases account for a large number of hospital admissions.~     We investigated the efficacy of hypnotherapy as an aid to a counseling-based smoking~     cessation program in improving quit rates of hospitalized smoking patients at 12 and 26 weeks~     after hospital discharge. We compared outcomes with hospitalized patients who received more~     conventional therapy, namely nicotine replacement therapy, or patients who decided to quit on~     their own. We also compared smoking cessation rates at 12 and 26 weeks after hospitalization~     among patients admitted with a cardiac or a pulmonary diagnosis.~   "
135643|NCT01791790|"~     The beneficial effect of nocturnal sleep on memory consolidation is well-documented in young,~     healthy subjects. Especially, periods rich in slow-wave sleep (SWS) have shown a memory~     enhancing effect on hippocampus-dependent declarative memory. Slow oscillatory activity~     typically occuring during SWS has been implicated in the consolidation effect. Recent~     evidence in young healthy subjects suggest that the sleep-associated consolidation effect can~     be amplified by the application of a weak transcranial oscillatory electric current within~     the frequency range of SWS in humans (0,7-0,8 Hz) during SWS. If elderly, healthy subjects~     benefit from transcranial slow oscillatory stimulation (tSOS) during nocturnal sleep as well~     has not been studied so far. The primary aim of the present study is to investigate the~     influence of a weak slow oscillating brain stimulation (tSOS) on declarative memory~     consolidation applied during periods of nocturnal SWS in elderly healthy subjects.~   "
135644|NCT01791777|"~     The proposed study will compare purveyor coaching (conducted by National SafeCare Training~     and Research Center (NSTRC)) to local coaching that is supported by the purveyor (NSTRC). The~     outcomes of interest are home visitor fidelity and competence with the SafeCare model, and~     family engagement and skill acquisition. The study will also include a rigorous cost~     effectiveness analysis, and will examine individual and organizational factors that may~     affect implementation.~   "
135645|NCT01791764|"~     This study has the following objective:~      To identify related factors to hospital mortality in patients with ST-segment elevation acute~     myocardial infarction submitted to pharmacoinvasive strategy within a structured healthcare~     network.~   "
135646|NCT01791751|"~     The purpose of this study is to evaluate the effect on LH levels of the 5-day CC~     administration during luteal phase in oocyte donors, to investigate whether the CC corrects~     the suppressed LH levels in the luteal phase and whether it prolongs the luteal phase in the~     agonist triggered antagonist cycles.~   "
135647|NCT01791738|"~     The proposed study is a double-blinded randomized controlled trial comparing patient specific~     instruments with solely standardized instruments and pre-operative planning used for the~     placement of the acetabular cup prosthesis used in total hip arthroplasty.~      The investigators will enroll 36 patients who have consented to total hip arthroplasty for~     treatment of hip pathology. This treatment is a standard of care. Patients will receive~     standard of care pre- and post-operative care and placement of standard of care implants all~     of which are commercially available and FDA approved for general use for the clinical~     indications used in these patients. All patients will receive a pre-operative CT scan for~     surgical planning and comparison with post-operative CT scan. The difference in intervention~     between the groups will be the creation and use of patient specific instruments from the~     pre-operative planning session. These instruments will be used for placement of an indexing~     peripheral guide wire to direct acetabular preparation and placement of the shell assisting~     standard surgical instruments. Print-offs from the pre-operative plan will also be used in~     the treatment group.~      The post-operative scan will be performed within two weeks of the surgery for both the~     treatment and control groups. The investigators will analyze the difference in acetabular~     shell placement (acetabular version and abduction angle) from the pre-operatively planned CT~     scan. These differences will be compared between the control and experimental groups.~   "
135648|NCT01791725|"~     This is a prospective, randomized, double-blind, placebo-controlled, parallel-group,~     three-arm, multicenter study of the safety and PK of ELND005 administered orally for 4 weeks.~     This study will enroll Down Syndrome patients 18 to 45 years of age (inclusive) without~     dementia.~   "
135649|NCT01791712|"~     Following the concept of peak concentration hypothesis, which suggest the cutting peak of~     pro- and anti-inflammatory mediators would result in restoring a situation of~     immunohomeostasis. The investigators conducted the prospective randomized controlled trial~     aimed to compare the clearance efficacy between on-line hemodiafiltration and high-flux~     hemodialysis in sepsis-related acute kidney injury patients. The lowering cytokines level~     during sepsis is postulated to improved outcomes in sepsis.~   "
135650|NCT01791699|"~     Hypothesis: Modulation of central nervous sympathetic activation by administration of~     moxonidine, a centrally acting medication which decreases the sympathetic nervous system~     activity, can lead to a decrease in atrial fibrillation recurrence after ablation treatment~     with pulmonary vein isolation.~   "
135651|NCT01791686|"~     This study is evaluating the study drug (CDX-1135) in patients with dense deposit disease~     (DDD). The objective is to evaluate the safety and activity of repeated doses of CDX-1135 in~     pediatric and adult patients with DDD. After screening, eligible patients will be entered~     into the Induction Period. The Induction Period is up to 4 weeks. Following normalization of~     complement activity, patients will enter into the Maintenance Period.The total treatment~     duration is up to 26 weeks.~   "
135652|NCT01791673|"~     The aim of the study is to evaluate the effectiveness and the safety of the cyclocoagulation~     using HIFU in glaucoma patients~   "
135843|NCT01789164|"~     The goal of this project is to determine if it is possible to assess Cerebrovascular~     Reactivity (CVR) to hypercapnia with functional Near Infrared Spectroscopy (fNIRS). Such a~     method would be particularly helpful in traumatic brain injury (TBI), where objective~     measures are needed, and would greatly expand the capacity to make such assessments in~     standard clinical practice.~   "
135653|NCT01791660|"~     Protocol is intended for the clinical evaluation of fat reduction in male breasts~     (pseudogynecomastia) using the ZELTIQ Coolsculpting System. The ZELTIQ Coolsculpting system~     has received market clearance from the U.S.FDA for non-invasive fat layer reduction in the~     flanks, and is commercially available.~      Primary study endpoint is changes in the shape and reduction of the fat in the breast as~     established by photographic imaging and ultrasound imaging of the treated area.~      Secondary endpoints will provide supportive data to evaluate device performance (subject~     satisfaction & fat reduction measured with ultrasound).~   "
135654|NCT01791647|"~     The aim of this study is to compare the effects of six months treatment of two~     insulin-lowering therapies on the clinical and endocrine-metabolic parameters in obese women~     affected by polycystic ovary syndrome. The study group includes 40 patients, randomly~     allocated to subgroup A (metformin 1500 mg/day) and subgroup B (myo-inositol 1500 mg/day).~     The investigations include menstrual pattern and hirsutism score evaluation, hormonal assays,~     oral glucose tolerance test, euglycemic hyperinsulinaemic clamp and lipid profile at baseline~     and after six months of treatment.~   "
135655|NCT01791634|"~     Is there a difference in clinical outcome measures as assessed by the AOFAS, SF-36 and Visual~     Analogue Scale of adult patients with moderate to severe hallux valgus with increased~     intermetatarsal angles treated with a proximal open wedge osteotomy with LPS system versus~     the proximal chevron osteotomy?~   "
135656|NCT01791621|"~     Irritable bowel syndrome (IBS) sufferers often find that specific foods can exacerbate their~     symptoms; identifying which foods involves a long and arduous process. Different food allergy~     tests are marketed to IBS sufferers and healthcare practitioners as an easy way to identify~     these offending foods. Which test method might be best to use? This project compares the~     results of different food allergy methods versus an elimination/challenge diet to determine~     which method maybe superior in IBS sufferers.~   "
135657|NCT01791608|"~     Acute respiratory infection and acute diarrhea are among the most prevalent diseases of~     childhood increase the burden of morbidity and mortality in children under 5 years.~      Among the possible strategies for its prevention is important to count on good nutritional~     status for use in developing a good immune response to infections. Zinc deficiency has been~     shown to favor the development of infections and has been considered a real public health~     problem.~      Within the zinc compounds used are zinc amino acid chelate and zinc sulphate, the first that~     has shown evidence of being better absorbed and tolerated.~      We propose a study showing the effectiveness of zinc amino acid chelate and zinc sulphate in~     the prevention of acute diarrheal disease and acute respiratory infection.~   "
135658|NCT01791595|"~     The main aims of this clinical study are to find out the maximum dose that can be given~     safely to patients, the potential side effects of the drug and how they can be managed and~     what happens to AZD3965 inside the body.~      AZD3965 is a type of drug called a monocarboxylate transporter 1 inhibitor which is being~     used to stop the growth of cancer cells and kill cancer cells by blocking the action of one~     of the proteins involved in moving chemical compounds in and out of the cells of the body.~     This will be the first time that this type of drug has been given to patients.~      The drug is a capsule and is taken daily. The study is in two parts. In Part 1, small groups~     of patients will be treated at increasing doses to find the highest safe dose and best dose~     to give to patients in Part 2 of the study. Approximately 18 patients with advanced solid~     tumours or lymphomas will be treated in this part.~      In Part 2, the dose found to be safe in Part 1 will be given to three groups of patients with~     either prostate cancer, gastric cancer or diffuse large B cell lymphoma. 15 patients will be~     treated in each group.~      Patients will need to visit the hospital weekly for two months and then every fortnight.~     Patients will have regular blood and urine tests, scans, heart traces and eye tests amongst~     other clinical tests. Research blood samples will also be taken to look at what happens to~     the drug inside the body. Treatment will continue until a patient's cancer starts growing but~     can continue for up to a maximum of 12 months if the cancer is responding to the drug. It is~     important to explain that this is the first study of this drug and patients will have~     advanced cancer so it is unlikely that patients will benefit directly from taking part but~     the study may help improve future treatment of cancer.~   "
135659|NCT01791582|"~     To assess performance of resp rate parameter in a monitoring system PCBA-1~   "
135660|NCT01791569|"~     To demonstrate that the sensor-off feature on the Pulse oximeter displays per specifications~     when the sensor is removed from the finger.~   "
135661|NCT01791556|"~     The study is funded through the Office of the Global AIDS Coordinator (OGAC #KE-07-0044). The~     purpose of this study is two-fold. The first purpose is to see if routine monitoring of the~     level of HIV virus in the blood (viral load) every six months is superior to monitoring by~     standard clinical evaluations and or immune status (CD4 count) with intermittent viral load~     monitoring in adults receiving antiretroviral therapy (ART). The second purpose is to~     understand the cost implications and possible benefits of routine HIV viral load monitoring.~   "
135662|NCT01791543|"~     The purpose of the study is to assess the effectiveness and safety of a new device called an~     Intramural Needle Ablation Catheter (INA catheter). The INA catheter is used for locating and~     ablating ventricular arrhythmias that have failed standard radiofrequency ablation. This~     approach is desirable because some people have ventricular arrhythmias that originate deep~     within the heart muscle where it is not abolished by ablation with standard catheters.~      The investigators seek to determine whether the INA catheter can potentially help people who~     have ventricular arrhythmias that have failed standard radiofrequency ablation. The~     investigators also want to determine if it is likely to be safe, without excessive side~     effects.~   "
135687|NCT01791218|"~     A substantial proportion of patients undergoing elective coronary artery bypass grafting have~     a history of paroxysmal atrial fibrillation. Paroxysmal atrial fibrillation has adverse~     short-and long term postoperative effects. Pulmonary vein isolation (PVI) seems to be~     effective treatment for paroxysmal atrial fibrillation. PVI can be done concomitantly with~     coronary artery bypass grafting, aortic valve replacement for aortic stenosis and combination~     of them. Procedure is well defined and safe.~      There is a lack of convincing evidence of the effect on postoperative atrial fibrillation~     burden, quality of life and symptoms especially in correlation with atrial fibrillation~     paroxysms.~   "
135663|NCT01791530|"~     Justification and background Ventilator-associated complications (VACs) are those~     complications that develop during a period of intubation of a patient . Pneumonia is the~     second most frequent infectious complication in the hospital, and ranks first in ICU, whose~     risk is increased more than 20 times by the presence of invasive mechanical ventilation and~     is called ventilator-associated pneumonia (VAP) . Whereas the information published regarding~     VAP in terms of diagnosis, treatment and impact on the outcome of critically ill patients is~     enormous.Ventilator-associated tracheobronchitis (VAT) incidence is lacking and complicated~     in part, since the definition remains controversial. In addition, the significance of~     tracheobronchial colonization as a risk factor for subsequent lower respiratory tract~     infection remains unclear . The upper and lower airways can become colonized . Several~     factors have been taken into account and do not differ from those involved in VAT and VAP~     development in patients under mechanical ventilation.~      Definition VAT diagnosis is controversial and represents an actual problem in order to define~     the real incidence of VAT , There is currently no valid, reliable definition for VAT, and~     even the most widely-used VAT criteria and definitions are neither sensitive nor specific.~     The diagnosis of VAT is considered when a patient under invasive mechanical ventilation~     starts with fever, leukocytosis and new or increased purulent secretions by the endotracheal~     tube. A particular difficulty with much commonly used VAT definition (in order to distinguish~     from VAP) is the key point of the absence of pulmonary consolidation. Evidence suggests that~     chest radiograph findings do not accurately role out VAP. A taskforce on hospital-acquired~     pneumonia, and VAP has been recently published (European Respiratory Society (ERS), European~     Society of Clinical Microbiology and Infectious Diseases (ESCMID) and European Society of~     Intensive Care Medicine (ESICM)). Nosocomial tracheobronchitis definition includes occurrence~     of purulent tracheal secretion after ≥48 h of hospitalisation or mechanical ventilation plus~     ≥2 of the following: fever (≥38.5°C) or hypothermia (<36°C), leukocytosis (≥12 × 109/L),~     significant bacteriologic counts in respiratory secretions (≥103 cfu/mL for protected brush~     specimen (PBS) and ≥105 cfu/mL for endotracheal aspirates); absence of new pulmonary~     infiltrates compatible with pneumonia and absence of other causes of fever are mandatory.~     This definition needs to be further validated and can overdiagnose the incidence of VAT (and~     overuse of antibiotics) because the positive culture of respiratory secretions is not a~     mandatory item RATIONALE Given the possible high incidence of VAT, and its importance as a~     risk factor for VAP, and a potential target to treat in order to reduce VAP incidence, a~     large multicentre~   "
135664|NCT01791517|"~     The purpose of this study is to evaluate the clinical and laboratory performance of three~     brand name contact lenses with three recently introduced multipurpose lens care solutions~     (test solutions) as well as a peroxide disinfecting solution (control solution).~   "
135665|NCT01791504|"~     The purpose of this study is to determine if TissuGlu® Surgical Adhesive is safe and~     effective alternative to drains(standard of care) for fluid management following~     abdominoplasty. It is hypothesized that the use of the Cohera device will facilitate~     reduction or closure of dead space when applied to planar surfaces created during an~     abdominoplasty procedure.~   "
135666|NCT01791491|"~     The purpose of this study is to evaluate how well adolescent kidney transplant patients~     tolerate a single dose of belatacept they receive at least 6 months after transplant surgery,~     and how their body handles the drug.~   "
135667|NCT01791478|"~     This phase I trial studies the side effects and best dose of the PI3K inhibitor BYL719 when~     given together with letrozole in treating patients with hormone receptor-positive metastatic~     breast cancer. The PI3K inhibitor BYL719 may stop the growth of tumor cells by blocking some~     of the proteins needed for cell growth. Hormone therapy using letrozole may fight breast~     cancer by blocking the use of estrogen by the tumor cells. Giving the PI3K inhibitor BYL719~     together with letrozole may kill more tumor cells~   "
135668|NCT01791465|"~     This pilot study will evaluate the effects of the anti-diabetic drug Bydureon (exenatide~     extended-release formulation) on blood sugar levels and serum markers of inflammation in a~     cohort of 12 HIV-infected adults on combination antiretroviral therapy (cART) with untreated~     diabetes mellitus. Previous studies have shown that high levels of persistent systemic~     inflammation predict the development of cardiovascular and metabolic diseases in HIV-infected~     persons on cART (a group at very high risk of atherosclerosis and myocardial infarction).~     Bydureon has demonstrated potent anti-inflammatory effects in prior studies of non-HIV~     infected persons, which suggests that this agent may represent a unique and preferred~     medication for the treatment of insulin resistance in HIV-infected adults. The Investigators~     hypothesize that short-term (16 weeks) therapy with Bydureon will improve glucose tolerance~     and significantly reduce circulating plasma levels of interleukin-6 (IL-6) and~     highly-sensitive C-reactive protein (hsCRP), two biomarkers strongly implicated in the~     development of cardiovascular and metabolic diseases in diabetic, HIV-infected, cART-treated~     adults.~   "
135669|NCT01791452|"~     Non-alcoholic fatty liver disease (NAFLD) is a world-wide problem with a global prevalence~     estimated at 1.5 billion people. It is characterised by significant diversity and phenotypic~     heterogeneity. Morbidity rates are estimated at 20% to 30% in Western adults, increasing to~     90% in patients who are morbidly obese or diabetic. Risk factors in non-obese NAFLD patients~     are of especial practical and theoretical importance. Cholesterol Ester Storage Disease~     (CESD) is an autosomal recessive chronic disease of variable phenotype, caused by a~     deficiency in lysosomal acid lipase (LAL) and characterized by accumulation of fat in tissues~     and organs. Hepatic accumulation of fat in this disorder can cause hepatomegaly with varying~     degrees of damage varying from steatosis to fibrosis, elevated aminotransaminases, and~     isolated splenomegaly. Since the contribution of LAL deficiency to non-obese NAFLD is poorly~     understood, the investigators propose to evaluating the association between NAFLD and LAL~     deficiency in a prospective study in our population.~   "
135670|NCT01791439|"~     The investigators wish to determine if application of 2% lidocaine soaked gauze to the~     peritonsillar pillars will decrease the amount of gagging caused by awake videolaryngocope~     assisted tracheal intubation in the morbidly obese.~   "
135671|NCT01791426|"~     The objective of this investigation is to show that the performance of Artelac Rebalance eye~     drops is non-inferior to that of Vismed eye drops in subjects with moderate to severe dry~     eye, and to assess the safety of Artelac Rebalance after a 90-day (± 10 day) treatment~     administered 3 to 5 times per day.~   "
135672|NCT01791413|"~     The purpose of this study is to evaluate the ovarian reserve changes after preoperative depot~     medroxyprogesterone acetate (DMPA) in women with ovarian endometrioma undergoing laparoscopic~     cystectomy.~   "
135673|NCT01791400|"~     The purpose of this study is to determine which drug makes lower migraine headache~   "
135688|NCT01791205|"~     This is a multicenter observational study in patients with rheumatoid arthritis in routine~     clinical practice in Italy. In the retrospective Part 1 of the study, clinical and~     demographic factors associated with the use of a biologic drug in monotherapy as compared to~     therapy in combination with Disease-modifying anti-rheumatic drugs (DMARDs) will be~     evaluated. In the retrospective/prospective Part 2 of the study, efficacy and safety of the~     use of RoActemra/Actemra (tocilizumab) in monotherapy will be evaluated. Patients will be~     followed for up to18 months.~   "
135689|NCT01791192|"~     This study will assess the safety, tolerability, and efficacy of FTY720 in patients with~     acute, noninfectious intermediate, posterior and pan uveitis~   "
135674|NCT01791387|"~     The main purpose of this study is to find out how useful dovitinib is when given as the~     initial treatment to participants with advanced kidney cancer, that has spread to other parts~     of the body. The usefulness of dovitinib will be assessed by: how long the disease is~     controlled while participants are receiving the drug, the proportion of participants who get~     a reduction in the size of their tumours and how long participants live (both while on~     dovitinib and on any subsequent therapy they may receive).~      If participants have secondary disease in the bones, the study will evaluate how useful~     dovitinib is in controlling this site of disease. In addition, this study will look for~     changes in the genetic makeup of tumour cells and see if some of these changes are associated~     with a benefit from dovitinib. The study will also compare and contrast the genetic changes~     in the primary tumour cells with cells from secondary tumour specimens, and with cells from~     tumour specimens taken if a participant's disease has worsened. The purpose of the latter is~     to identify possible ways in which the tumour becomes resistant to the study drug.~   "
135675|NCT01791374|"~     This is an open label phase 1/1b study of Rilotumumab in Japanese subjects with advanced~     solid tumors or metastatic gastric esphagogastric (GEJ) adenocarcinoma.~   "
135676|NCT01791361|"~     This non-interventional retrospective medical record review study will assess the prevalence~     of KRAS testing and the impact of the KRAS test result on patterns of Vectibix use in~     patients with metastatic colorectal cancer (mCRC) treated with Vectibix in selected European~     countries over 3 rounds. As the optimal use of Vectibix also requires accurate KRAS mutation~     testing, this study will also assess data from the laboratory that performed the KRAS test.~     The study will also monitor changes in the pattern of Vectibix treatment between the~     different rounds of the study.~   "
135677|NCT01791348|"~     The d2 test of attention has been used in studies regarding sleep deprivation due to night~     shifts in hospital staff, in order to determine whether sleep deprivation has an impact on~     performance. However, by repeating the test there appears to be a test-retest effect, as the~     participants improve when performing the test more than once. The aim of this study is to~     determine, whether the d2 test of attention has a test-retest effect.~   "
135678|NCT01791335|"~     Noninvasive ventilation (NIV) can provide ventilatory support in selected patients with acute~     respiratory failure, for instance due to acute exacerbation of COPD and acute heart failure.~     Advantages of noninvasive ventilation compared to invasive mechanical ventilation include~     absence of complications associated with endotracheal intubation, lower risk of pneumonia,~     lower level or even absence of sedation and the ability of the patient to verbally~     communicate. However, in approximately 30% of patients NIV fails and endotracheal intubation~     is needed to provide optimal ventilatory support. Surprisingly, very few studies have~     investigated why patients fail on NIV. Clinical observations indicated that agitation,~     delirium and most importantly asynchrony between patient and ventilator play a role in~     unsuccessful support with NIV. The upper airways are bypassed during endotracheal intubation.~     However, with NIV the upper airways may play a role in the efficiency of ventilatory support.~     In normal breathing the upper airways actively dilate before initiation of inspiratory flow.~     This is a highly appropriate response as it prevents narrowing of the upper airways during~     inspiration, which would result in elevated inspiratory resistance. Experiments in newborn~     lambs have shown that NIV has profound effects on physiology of the upper airways. Positive~     pressure during inspiration results in constriction of upper airway muscles in the early~     phase of inspiration. This results in elevated upper airway resistance with lower tidal~     volume delivered to the lungs. Subsequent studies revealed that reflexes that mediate this~     response originate in vagal afferences located in the lower airways. From an evolutionary~     point of view this might be an appropriate response, as high pressure delivered to the lungs~     may induce barotraumas. However, these responses may negatively affect the efficiency of~     ventilatory support delivered during NIV. The understanding of upper airway constriction and~     dilation during NIV is rudimentary. This study aims at determining the effect of NIV on~     regulation of upper airway patency in patients with COPD.~   "
135679|NCT01791322|"~     NovellusDx is developing a diagnostic platform for the personalized cancer therapy based on~     patient derived tumor tissue. The assay is able to sense activating mutations by monitoring~     their effect on a chip-based device.~   "
135680|NCT01791309|"~     The purpose of this study is to test a new drug combination consisting of two drugs,~     vemurafenib (also known as ZelborafTM) and panitumumab (also known as VectibixTM). This~     treatment is being tested in a subgroup of patients with colorectal cancer whose tumors have~     changes in the BRAF gene that may make them more likely to respond to this new drug~     combination.~   "
135681|NCT01791296|"~     Specific Aims~        1. Establish the feasibility of larger trial by implementing a sleep protocol in the ICU at~          2 different sites. Specifically will be estimating the recruitment rates of patients and~          the compliance with both interventions.~        2. Measure the safety and tolerance of adding night-time sedation with dexmedetomidine~          using adverse effects and withdrawal rates as indicators.~        3. Measure the effect of nocturnal dexmedetomidine on pertinent clinical outcomes and use~          this outcome data to plan a larger, multicenter trial in this area.~      The goal of this study is to determine whether a night-time protocol that incorporates a~     pharmacologic intervention associated with improved sleep (i.e. dexmedetomidine) will improve~     sleep quality and reduce the incidence of delirium and sub-syndromal delirium in critically~     ill patients.~   "
135682|NCT01791283|"~     Real-time comparison of three different bedside strokevolumemeasurements (arterial waveform~     analysis, eosofageal doppler and 2D transthoracal ultrasound) validated against cardiac~     magnetic resonance imaging (CMRI)~   "
135683|NCT01791270|"~     To describe the relationship between OSA and clinical Hypertension (performing ABPM),~     endothelial dysfunction (performing flowmetry), and its relation at the basic research~     (determining the β1 subunit in Peripheral Leukocytes in peripheral blood). This relation~     between OSA and HTA has been evaluated in basal conditions and after modifying the~     pathophysiological role of OSA applying treatment with positive continues pressure (CPAP)~     during 3 months.~   "
135684|NCT01791257|"~     The purpose of this study is to compare the profile of microRNA in cerebrospinal fluid from~     patients suffering subarachnoid hemorrhage with and without delayed cerebral ischemia.~   "
135685|NCT01791244|"~     This is a randomized, comparative, and multicenter study to assess the impact of a patient~     support program (MinSupport Plus) on health related quality of life (HRQoL) and adherence in~     subjects with relapsing-remitting multiple sclerosis administered Rebif® with the RebiSmart™~     device.~   "
135686|NCT01791231|"~     The purpose of this study is to investigate the absorption (the way the drug enters the~     body), metabolism (the way the drug is broken down in the body), and excretion (the way drug~     leaves the body) of canagliflozin (JNJ-28431754) in healthy male volunteers after a single~     dose of radiolabeled 14C-canagliflozin (14C-JNJ-28431754). The safety and tolerability of~     canagliflozin will also be assessed.~   "
137562|NCT01766674|"~     This is a randomized, controlled trial among 100 total males and females with hyperkyphosis,~     aged 60 years and older, to determine the effects of an exercise intervention that includes~     high intensity spinal muscle strengthening exercises compared to a usual care waitlist group.~   "
135690|NCT01791179|"~     Substance abuse is highly prevalent among individuals with HIV and associated with negative~     outcomes including poorer medication adherence and HIV risk behavior. The primary aim of this~     project is to address substance abuse among individuals with or at high-risk for HIV by~     enhancing and expanding the substance abuse services provided in the formerly Substance Abuse~     and Mental Health Services Administration (SAMHSA) funded Carolinas Alcohol and Drug~     Expansion Team (CADET) program, which offered comprehensive substance abuse care for~     individuals with HIV living primarily in the Durham NC area. Services will be enhanced by~     adding peer outreach and navigation services to improve treatment engagement and~     participation and expanded to replicate the enhanced CADET service model in Charlotte NC.~      The target population for this project is minority individuals, primarily African-Americans,~     with HIV or at high-risk for HIV with a particular focus on minority men who have sex with~     men (MSM)s. The program will provide up to 18 months of comprehensive services for~     approximately 315 individuals and will include: 1) peer outreach to facilitate and enhance~     treatment engagement 2) individual and group substance abuse treatment using evidence-based~     models 3) ongoing recovery groups for individuals who have completed the intensive substance~     abuse treatment phase and 4) linkage to needed services such as case management, psychiatric~     care, and HIV/Hepatitis medical care. We will also target HIV and Hepatitis C testing and~     treatment services for minority MSM of unknown HIV status to increase access and utilization~     of substance use services and identify HIV and Hepatitis status.~      The study evaluation will involve analysis of participant survey data gathered at baseline,~     6, 12, 18 months of study participation to determine the effect of the comprehensive~     substance abuse care services on outcomes for individuals with HIV including substance use,~     mental health, HIV treatment adherence, HIV risk behavior, and access and utilization of HIV~     services. The study will also determine the effect of the comprehensive substance use program~     on substance abuse, mental health, and risk behavior outcomes for minority MSM who are not~     HIV-positive.~   "
135691|NCT01791166|"~     Open multicentric prospective study performed on pulmonary transplanted patients to detect~     the values of different diagnostic markers for immuno- humoral reaction and their roles in~     the humoral rejection for those patients.~   "
135692|NCT01791153|"~     This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will~     evaluate the efficacy and safety of tocilizumab in participants with GCA. The study will~     consist of 2 parts: a 52-week double-blind treatment period (Part 1) followed by a 104-week~     open label long-term follow-up period (Part 2). In Part 1 of the study eligible participants~     will be randomized to receive either tocilizumab every week (qw) or every 2 weeks (q2w) or~     placebo for 52 weeks, with tapering oral daily doses of prednisone. After Week 52,~     participants in remission will stop study treatment and enter long-term follow-up, whereas~     participants with disease activity or flares will receive open-label tocilizumab or other~     treatment at the discretion of the investigator for a maximum period of 104 weeks.~   "
135693|NCT01791140|"~     This observational study will evaluate the efficacy and safety of Avastin (bevacizumab) in~     combination with fluoropyrimidine-based chemotherapy in elderly patients (>/= 65 years of~     age) with newly diagnosed metastatic colorectal cancer. Patients will be followed until~     disease progression, death, withdrawal of consent, discontinuation of physician-patient~     relationship or study closure, whichever comes first.~   "
135694|NCT01791127|"~     The objective of the SIELLO study is to demonstrate the safety and effectiveness of the~     BIOTRONIK Siello S pacing lead.~   "
135695|NCT01791114|"~     Recent findings document the presence of active brown adipose tissue (BAT) in humans. Cold~     exposure via adrenergic stimulation activates BAT, which combusts significant amounts of~     blood glucose and free fatty acid (FFA) to produce heat. Animal studies suggest that BAT~     activation improves insulin sensitivity. However, the effect of cold-induced BAT activation~     on insulin sensitivity and glucose kinetics in humans remains unknown. The investigators'~     central hypothesis is that cold-induced BAT activation increases whole body insulin~     sensitivity in humans via augmented plasma glucose and FFA clearance. The specific aims of~     this study are to define the effects of prolonged (8h) cold exposure BAT activation on:~     insulin sensitivity (Aim 1); lipolysis and plasma glucose and FFA kinetics (Aim 2); on~     thermoregulation (Aim 3). Moreover, the investigators plan to investigate for alternative~     ways, which can activate BAT including cold water ingestion, a single meal ingestion, and a~     single bout of moderate intensity exercise (Aim 4). For the cold exposure study, subjects~     will complete 3 trials: a) 8hrs of cold exposure at their individually determined shivering~     threshold; b) 8hrs of cold exposure at their individually determined shivering threshold plus~     propranolol; c) 8hrs in thermoneutral conditions (26 - 28°C). For the rest of the arms of~     subjects will complete two trials: cold or tepid water ingestion, a single meal ingestion or~     no food ingestion, and a single bout of moderate intensity exercise or no exercise.To study~     the above aims, the investigators will use positron emission tomography - computed~     tomography, hyperinsulinemic euglycemic clamp, infusion of stable isotopes, and tissue~     biopsies. The findings will illuminate the role of BAT on plasma substrate regulation and~     insulin sensitivity and may aid in the development of lifestyle recommendations and~     pharmacotherapy for the prevention and treatment of diabetes and insulin resistance.~   "
135696|NCT01791101|"~     This is a Phase II multicentre study. Patients will be administered eltrombopag 50 mg/daily.~     If patients don't achieve response after 2 months of therapy they will stop eltrombopag; if~     patients will achieve response after 2 months of therapy, they will continue eltrombopag for~     a maximum period of 24 months; 40 patients are needed. In stage I, 22 patients will be~     enrolled; if ≤ 4 responses at the first evaluation after 2 months (18%) will be seen, the~     trial will be stopped; if 5 or more responses will be seen, the accrual will continue. In~     stage II, 18 more patients will be enrolled. If ≤ 12 (30%) responses will be observed out of~     40 patients, it will be concluded that the study drug is not active enough. If ≥ 13 responses~     will be observed, it will be concluded that eltrombopag is worth of further studies.~   "
135697|NCT01791088|"~     This clinical trial studies sirolimus in treating patients with solid tumors that are~     metastatic or cannot be removed by surgery. Sirolimus may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth~   "
135698|NCT01791075|"~     The purpose of this study is to compare the Tan EndoGlide with the new Endoserter injector in~     terms of damage to the donor corneal endothelium by comparing the endothelial cell loss at 1~     month, 3 months, 6 months, and 1 year post DSAEK (Descemet's Stripping Automated Endothelial~     Keratoplasty)surgery. There is no data comparing this two injectors.~   "
135699|NCT01791062|"~     The two-layer bioresorbable HYTOP® matrix consists of an upper layer of highly purified~     porcine splint-skin which contains natural pores, and a lower layer of highly purified~     collagen fleece containing hyaluronan (HA).~      In this study, the medical device will be used and evaluated in a one-step procedure~     combining microfracturing with surgical implantation of HYTOP®. HYTOP® will support~     haemostasis in the articular cartilage defect, act as a support for cell growth and as a~     three-dimensional scaffold for cell differentiation. HYTOP® will protect the underlying~     tissue after cartilage debridement and/or microfracturing of the subchondral bone.~      The primary working hypothesis is that HYTOP® is safe and suitable as a cell-free matrix to~     support haemostasis, as a cover for the cartilage lesion and eventually to enhance cartilage~     regeneration in a one-step surgical procedure.~   "
135700|NCT01791049|"~     TD-1607, administered intravenously as single doses, will be investigated in healthy subjects~     to assess its tolerability, safety, and pharmacokinetics.~   "
135701|NCT01791036|"~     Adductor canal block will provide adequate analgesia to patients undergoing arthroscopic ACL~     reconstruction surgery, yet result in less motor blockade than a femoral block.~   "
138900|NCT01749215|"~     The goal of this project is to improve the treatment of veterans with co-occurring alcohol~     dependence and posttraumatic stress disorder (PTSD). The PI and co-investigators will conduct~     a controlled clinical trial of topiramate for the treatment of these co-occurring disorders.~   "
135702|NCT01791023|"~     Depressive elderly individuals have showed higher basal level of cortisol and lower level of~     dehydroepiandrosterone (DHEA). Moreover, changes on these hormone levels have also observed~     in reactivity of an acute stress, such as physical exercise. On the other hand, physical~     training can modulate the release of these hormones. Therefore, depressive elderly~     individuals physically actives might show attenuated reactivity of an acute physical stressor~     compared to sedentary elderly individuals. The aim of these study is to compare the effect of~     an acute physical stressor on cortisol levels in depressive and healthy individuals,~     physically actives and sedentaries. Additionally, the sulfated form of DHEA (DHEAS) serves as~     a reservoir for DHEA, because of that it is expected that DHEAS levels might reduce after the~     acute physical exercise.~   "
135703|NCT01791010|"~     Aging causes anatomical and physiological changes in the respiratory system and respiratory~     muscle strength with decline in its maximum function. This study aimed to evaluate the~     effects of inspiratory muscle training on respiratory muscle strength, thickness of the~     diaphragm and diaphragmatic mobility in older women. The investigators' hypothesis is that~     inspiratory muscle training improves respiratory muscle strength, the thickness of the~     diaphragm and diaphragmatic mobility in older women.~   "
135704|NCT01790997|"~     This is a 3-arm, prospective, randomized, double-blind, and controlled clinical study, with 3~     months of treatment to evaluate efficacy of DLBS1033 in bleeding profile and clinical outcome~     in patients with acute ischemic stroke compared with aspirin and clopidogrel, as active~     controls.~   "
135705|NCT01790984|"~     The hypothesis of this study is that a diet high in sugars will increase abnormalities in~     blood lipids which are associated with increased cardiovascular disease risk, relative to a~     diet which is low in sugar. We predict that this potentially adverse effect of dietary sugars~     on blood lipids will be more pronounced in people with a raised level of stored fat inside~     their liver, as compared to people with a low level of stored fat.~   "
135706|NCT01790971|"~     Patients with Obstructive Sleep Apnea (OSA) appear to be especially vulnerable to medications~     that suppress pharyngeal muscle activity such as general anesthetics and opioids. Opioids can~     depress the ventilator response to airway obstruction and inhibit the awakening response to~     hypoxia and hypercarbia, resulting in central respiratory depression. OSA is therefore an~     important risk factor for serious postoperative complications, including perioperative death.~     While OSA is increasingly recognized as a serious perioperative concern, current clinical~     practices are highly inconsistent with regard to the management of surgical patients with~     OSA. Additionally, the relative safety of intrathecal opioids in this patient population~     remains unknown.~   "
135707|NCT01790958|"~     Microcurrent stimulation thereapy improves retinal efficiency and may restore and/or improve~     retinal function.~   "
135708|NCT01790945|"~     The purpose of this study is explore if a partnership and screening program put in place~     between a busy retina practice and their referring diabetes care offices can improve diabetic~     retinopathy and diabetic macular edema diagnosis, care and overall diabetes control in~     patients with diabetic eye disease.~   "
135709|NCT01790932|"~     This research study is a Phase II clinical trial. Phase II clinical trials test the~     effectiveness of an investigational drug to learn whether the drug works in treating a~     specific cancer. Investigational means that the drug is still being studied and that~     research doctors are trying to find out more about it-such as the safest dose to use, the~     side effects it may cause, and if the drug is effective for treating different types of~     cancer. It also means that the FDA has not yet approved BKM120 for use in patients, including~     people with your type of cancer.~      BKM120 is a drug that works by blocking a protein called PI3K which may contribute to cancer~     growth. This drug has been used in experiments in the laboratory and information from these~     research studies suggests that BKM120 may help to prevent cancer cells from growing.~      In this research study, the investigators are looking to see if BKM120 works to stop breast~     cancer cells from growing.~   "
135710|NCT01790919|"~     Existing drug and talking therapies for major depressive disorder (MDD) fail to produce~     complete recovery. This study will determine if substantial improvements to one of the most~     promising therapies, cognitive therapy (CT), can be achieved by administering a carefully~     designed procedure to improve memory for the content of CT sessions. This is important~     because (a) memory deficits are common in MDD patients and (b) each CT therapy session~     typically covers a complex array of topics and various skills are taught.~   "
135711|NCT01790906|"~     To study whether renal sympathetic denervation(RSD) RSD can slow the progression of CHF and~     reduce the rate of all-cause mortality effectively and securely.~   "
135712|NCT01790893|"~     The purpose of this study is to monitor safety outcomes for patients being treated with~     intravitreal aflibercept injections for choroidal neovascularization secondary to Presumed~     Ocular Histoplasmosis Syndrome.~   "
135713|NCT01790880|"~     The purpose of this study is to evaluate whether a computerized speech-language treatment~     delivered by a virtual therapist (Oral Reading for Language in Aphasia (ORLA) + Writing)~     results in improved written communication skills of study participants with aphasia (i.e.,~     difficulty with the comprehension and expression of spoken and written language).~   "
135714|NCT01790854|"~     Aim: to verify if after the acute phase of ACS acute coronary syndrome (1-months), from 1 to~     12 months the reduction of maintenance dose of prasugrel from 10 mg to 5 mg/day may reduce~     the bleeding events (5 mg vs 10 mg). All patients will be treated with 325 mg of aspirin~     followed by a maintenance dosage of 100 mg of aspirin for at least 1 year. At baseline (after~     60 mg loading dose of prasugrel) and after 1 month (7 days after the randomization at 10 or 5~     mg of prasugrel) all patients will undergo light transmittance aggregometry (LTA) test to~     evaluate residual platelet reactivity (pharmacodynamic effects).~   "
135715|NCT01790841|"~     The purpose of the study is to proof the safety and efficacy of the new ICD sytem~     (Iforia/Ilesto). The devices are available with DF-1 and DF4 connection. A special focus is~     set on the ICD system with DF4 connection.~   "
135716|NCT01790828|"~     This study is to describe the safety and efficacy of Xyntha® during the usual care setting.~   "
136024|NCT01786759|"~     The etiology of parenteral nutrition-associated cholestasis(PNAC)although elusive is thought~     to be multifactorial, and proposed theories also include problems arising from lipid~     emulsions, leading us to explore alternative products available elsewhere.So we compare the~     different fat emulsion, and want to see if the olive oil lipid emulsions can improve hepatic~     tolerance in preterm infant.~   "
135717|NCT01790815|"~     PRIMARY OBJECTIVE :~      To determine whether mothers, given minimal group training, are capable of using a MUAC~     (mid-upper arm circumference) bracelet to screen their children for malnutrition and~     categorise them into one of three groups : 'red' (SAM ; severe acute malnutrition), 'yellow'~     (MAM ; moderate acute malnutrition) or 'green' (normal nutritional status)~      SECONDARY OBJECTIVES :~      To establish whether there is a difference in the MUAC value if measured on the right arm as~     opposed to the left, in young children~      To determine whether there is a difference in the MUAC value if the mid upper arm position is~     determined visually as opposed to being measured in the 'classical' fashion~   "
135718|NCT01790802|"~     The purpose of this study is to determine whether 2RT nanosecond laser therapy slows the~     progression to advanced age-related macular degeneration.~   "
135719|NCT01790789|"~     The purpose of this study is to investigate the effects of a stress reduction program on the~     quality of life of ovarian cancer patients during primary adjuvant chemotherapy.~   "
135720|NCT01790776|"~     Conventional urethrography is the standard diagnostic evaluation for patients with a~     suspicion of urethral stricture. The radiation dose of this examination is 5-9 mSV.~     Sono-urethrography was introduced in 1988 (McAninch et al. , J Urol 1988); the diagnostic~     accuracy of sono-urethrography is equal compared to conventional urethrography, with even a~     better measurement of stricture length and degree of spongiofibrosis with sono-urethrography.~     However, sono-urethrography remained underused among urologists and radiologists.~      Patients will be randomly assigned into two groups:~      Group A: conventional urethrography Group B: sono-urethrography In case sono-urethrography is~     inconclusive or of poor quality, a conventional urethrography will be performed.~      The radiation dose in the two groups will be measured. The stricture length and location will~     be recorded and compared with the perioperative findings in order to evaluate the diagnostic~     accuracy. The complications of the procedure(s) will be recorded with a questionnaire~     directly after and two weeks after the conventional or sono-urethrography.~   "
135721|NCT01790763|"~     The purpose of this study is to determine the extent to which Keramatrix dressing promotes~     the healing of second-degree burn wounds in pediatric patients.~   "
135722|NCT01790750|"~     This is a single-center, feasibility study involving all neonates admitted to the neonatal~     intensive care unit with orders for a cardiac echo evaluation. Parents will be approached and~     provided a description of the study. No written consent will be requested, but parents have~     the option of opting out. Each patient will have a 5 minute Pocket echocardiography system~     scan followed by a full echo performed on a traditional full featured echo system. The~     objective is to assess if the current Food and Drug administration (FDA) approved Pocket~     echocardiography system (PES) can detect patent ductus arteriosus (PDA) in neonates as~     comparable to traditional full featured echo systems (FFES) and/or physical exam alone.~   "
135723|NCT01790737|"~     The purpose of this study is to determinate the efficacy and safety of the 3-drug induction~     treatment (RVD; lenalidomide plus bortezomib plus dexamethasone)followed by randomized~     autologous stem cell mobilization, autologous stem cell transplantation and lenalidomide~     maintenance. Primary endpoint is the immunophenotypic remission rate.During the randomized~     mobilization phase two active comparator arms Cyclophosphamide (CY)2g/m2 + Granulocyte-colony~     stimulating factor(G-CSF) vrs G-CSF will be compared regarding efficacy, costs and safety.~   "
135724|NCT01790724|"~     The propose of the study is to test the hypothesis that an eight week program consisting of~     walking exercise and social cognitive theory based group workshops will increase physical~     activity adherence six months later in older adults with type 2 diabetes or metabolic~     syndrome.~   "
135725|NCT01790711|"~     The gut microbiota is considered to constitute a microbial organ which has pivotal roles in~     the body's metabolism. Evidence from animal and human studies strongly support the link~     between intestinal bacteria and type 2 diabetes mellitus. The present clinical trial aims to~     re-establish a gut functionality state of intestinal flora through fecal microbiota~     transplantation.~   "
135726|NCT01790698|"~     This proposal focuses on highly lethal destructive tissue infections, i.e. necrotizing~     fasciitis and other necrotizing soft tissue infections (NSTIs), which are associated with~     high morbidity and mortality. The fulminant course of NSTIs demands immediate diagnosis and~     adequate interventions in order to salvage lives and limbs. However, diagnosis and management~     are difficult due to heterogeneity in clinical presentation, in co-morbidities and in~     microbiological aetiology. Thus, there is an urgent need for novel diagnostics and~     therapeutics in order to improve outcome of NSTIs. A comprehensive knowledge of diagnostic~     features, causative microbial agent, treatment strategies, and pathogenic mechanisms (host~     and bacterial disease traits and their underlying interaction network) is required for an~     improved diagnosis and management of NSTIs. The current proposal is designed to obtain such~     insights through an integrated systems biology approach in patients and experimental models.~     The project is based on a prospective NSTI patients cohort including a clinical registry to~     document clinical data and treatment strategies, combined with an isolate and biobank~     collection. The samples will be analyzed through advanced bioinformatics and computational~     modelling work flow to identify and quantify pathogen signatures and underlying networks that~     contribute to disease outcome. One aim is to translate clinical and systems biology data into~     development of novel diagnostics.~   "
135727|NCT01790685|"~     To measure the pro-permeability factors in the aqueous humor of patients with~     persistent/recurrent macular edema after an injection of Ozurdex.~   "
135728|NCT01790672|"~     The study is aimed at establishing the contribution of wine components on hydroxytyrosol body~     concentrations and biological effects.~   "
135729|NCT01790659|"~     This study is a pivotal Phase 3, randomized, double-blind, 3-site, two-group trial assessing~     the efficacy and safety of WR 279,396 Topical Cream and Paromomycin Alone Topical Cream in~     subjects with CL in Panama. The primary objective of this study is to determine if WR 279,396~     results in statistically superior final clinical cure rates of an index lesion when compared~     with Paromomycin Alone for the treatment of CL in Panama expected to be caused by L~     panamensis.~   "
135730|NCT01790646|"~     Glidescope laryngoscope was introduced as a novel tool for difficult intubation. Its learning~     curve was prooved on manikin but not in adult patients.~   "
138901|NCT01749202|"~     The purpose of this study is to assess the effect of stearidonic acid when used as a food~     ingredient on eicosapentaenoic enrichment of red blood cell membranes and Omega-3 Index in~     men and women.~   "
135731|NCT01790633|"~     This is a pilot, monocentric, prospective, randomized control trial looking at the use of~     rapid tests as a part of normal care. The investigators will be testing for hepatitis B virus~     (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV). Testing will be~     proposed to all persons seeking care at the Centre d'Accueil, de Soins et d'Orientation from~     the organization Médecin du Monde (CASO, MDM).~      Infection status of participants will be determined by either the standard test (ELISA) or~     rapid test. The choice between tests will be determined randomly.~      The overall goal is to determine the general acceptability and feasibility of rapid tests and~     to see if they can help individuals increase their awareness of infection status when~     compared to longer, routine methods of testing. In addition, results from these tests will~     allow the medical doctor to guide participants to appropriate care. All positive tests will~     be confirmed at a specialized hospital (Hôptial Saint-Antoine, Paris, France) and~     health-specific information will be obtained four months after testing.~   "
135732|NCT01790620|"~     Septic patients with acute kidney injury (AKI) requiring continuous renal replacement~     therapies (CRRT) present high mortality due to systemic inflammatory response, cytokine~     liberation, and finally multiorgan dysfunction. Cytokine plasmatic elimination with~     continuous venovenous hemofiltration (CVVH) presents frequent complications, known as~     dialytrauma, and a high resource cost both technical and human. The study primary end-point~     is to demonstrate a non-inferiority survival of continuous venovenous hemodialysis (CVVHD)~     respect to CVVH, both modalities employing the same adsorption capacity membrane. As~     secondary end-points investigators will try to demonstrate immunomodulation and technical~     superiority of CVVHD respect to CVVH. In order to achieve these objectives investigators have~     designed a proof of concept exploratory trial that will include those patients whom present~     sepsis and AKI meeting CRRT initiation criteria. During the first 72 hours investigators will~     measure plasmatic elimination capacity of main cytokines, and other clinical and prognostic~     relevant molecules. Investigators will also measure hemodynamic, respiratory, and metabolic~     parameters. Adverse effects related to CRRT (dialytrauma) will also be registrated.~     Finally, investigators will analyze 90 days survival. Demonstration of a non inferiority~     survival added to a superior immunomodulating capacity and a minor complication rate with its~     consequent lower cost, should settle the based evidence principles that recommend the use of~     CVVHD asociated to an adsorption capacity membrane in septic patients with AKI whom need~     CRRT.~   "
135733|NCT01790607|"~     To evaluate and compare the pharmacokinetics and safety of ONO-2745/CNS 7056 in subjects with~     the hepatic impairment and matched healthy subjects.~   "
135734|NCT01790594|"~     The purpose of this study is to find out if the drug NULOJIX® (belatacept) will minimize the~     amount of other anti-rejection medications necessary and thereby reduce the long-term side~     effects caused by the other medications. The researchers also want to learn more about the~     safety of this treatment and long term health of transplanted pancreases and kidneys.~   "
135735|NCT01790581|"~     Chronic Ankle Instability (CAI) is a health condition that results in repeated ankle sprains~     and other residual impairments. CAI has been linked to many different causative factors~     including sensory and motor deficits that affect the global function of the sensorimotor~     system as well as the patient. Over the past 20 years, strong evidence has been generated to~     support balance training as an effective intervention strategy in the CAI population.~     Unfortunately, most investigations have focused solely on maximizing motor output through~     balance training, while ignoring the full spectrum of sensorimotor dysfunction associated~     with CAI. There may be advantageous sensory-targeted interventions that augment the effects~     of balance training and lead to greater enhancements of functional outcomes for CAI. However,~     this possibility has not been systematically explored. Sensory-targeted ankle rehabilitation~     strategies (STARS), such as joint mobilization and plantar massage have resulted in improved~     sensorimotor function in those with CAI. However, only a single STARS (i.e. stochastic~     resonance) has been investigated in combination with balance training. While the combined~     effects were greater than those of balance training alone, stochastic resonance requires~     relatively expensive equipment that is not commercially available. Thus, the purpose of this~     investigation is to test the hypothesis that combining low cost STARS (e.g. plantar massage~     and joint mobilizations) with balance training will result in greater sensorimotor and~     functional improvements in those with CAI than balance training alone.~   "
135736|NCT01790568|"~     This protocol, UMCC 2012.047, was a pilot study initially intended for 12 subjects. After~     completing enrollment of the planned 12 subjects, we are extending the study to an additional~     25 subjects. The trial will examine the safety and efficacy of the addition of vorinostat,~     the study drug, to standard medications to try to prevent or lower the risk of graft~     versus-host disease (GVHD) for recipients of unrelated (matched) donor, blood or marrow stem~     cell transplants. The transplant regimens, chosen according to current institutional policy,~     will depend upon the recipients underlying disease (their blood cancer or other blood~     disorder), previous therapy, and current health issues. GVHD prophylaxis (preventive drug~     intervention) will be the local institutional standard for post-transplant immunosuppression,~     including tacrolimus and methotrexate, plus vorinostat. Vorinostat will be given twice daily~     orally beginning 10 days prior to the recipient's transplant and continue for up to 100 days~     after transplant.~   "
135737|NCT01790555|"~     Adequate treatment of postsurgical pain leads to better mobilization, shorter hospital stay,~     lower costs and higher patient satisfaction. In its treatment, frequent use is made of~     opioids. However, opioids have many side-effects. A possible add-on can be sought in THC,~     which has been shown to have possible analgesic and/or pain modulating effects in preclinical~     research. The purpose of this study is to investigate the analgesic and pain modulating~     effects of perioperative Namisol, a tablet containing THC, in patients that will undergo~     major abdominal surgery.~   "
135746|NCT01790438|"~     The purpose of this study is to compare LY2605541 and human insulin isophane suspension (NPH)~     using the following measures for participants treated for up to 26 weeks:~        -  Change in participants' overall blood sugar control~        -  The rate of night time low blood sugar episodes~        -  The number of participants that reach blood sugar targets without low night time blood~          sugar episodes~        -  The total number of low blood sugar episodes reported~   "
138928|NCT01748851|"~     The purpose of this study is to identify the non-inferiority of the combination therapy of~     Capecitabine and Oxaliplatin compared with the combination therapy of Fluorouracil/Folinic~     acid and Oxaliplatin in patients with advanced gastric cancer.~   "
135738|NCT01790542|"~     With the recent recommendation from Health Canada to extend exclusive breast-feeding to 6~     months of age there has arisen concern about what is the best solid food to introduce at that~     time. Traditionally solids were introduced in Canada at 4-6 months and usually iron-fortified~     rice cereal was the first food of choice. New recommendations from Health Canada include meat~     as a potential first food as well as other iron fortified foods. This has lead to uncertainty~     of both public health officials and parents about the optimal introduction and choice of~     solids after exclusive breastfeeding.~      In addition to meeting iron needs with the first solid food choice, the investigators are~     concerned about the possible generation of reactive oxygen species (ROS) in the gut of the~     infant fed traditional iron fortified cereals. Infant cereals are fortified at 25-30 mg iron~     per 100 g dry-weight. Absorption of the non-heme electrolytic iron ranges from 5-10% so that~     most of the residual iron enters the colon. Normally excess iron is sequestered by a variety~     of mechanisms in the body, but there is no such system for the sequestering of iron in the~     gut lumen. The investigators have shown that providing iron supplements to adults where the~     majority of the iron is unabsorbed passes through the digestive tract can lead to the~     generation of ROS in the colon. These effects are seen in adults receiving 1 mg/kg/day~     supplemental iron. By 5-6 months of age infants consuming iron fortified cereals will receive~     the same dose and are likely producing ROS in their digestive tract. This may cause~     inflammation and make infants more susceptible to disease. The investigators think that meats~     and infant cereals with phenolic antioxidants available from fruits will likely reduce the~     generation of ROS in vivo. Therefore the investigators wish to determine if traditional and~     newly recommended first foods are safe from a free radical and inflammatory perspective.~      HYPOTHESES:~        1. Consumption of infant cereals with iron will increase ROS generation in the gut~        2. Consumption of infant cereals with iron and fruit will decrease ROS in the gut~        3. Consumption of meat will not generate ROS~        4. Consumption of iron fortified cereals or meat will maintain iron status during infancy~   "
135739|NCT01790529|"~     Surgical site infections (SSI) are the most frequent hospital acquired infections in patients~     who underwent surgery. With regards to the increasing financial restraint in patient care,~     the socio-economic burden of SSI in the public health sector and its prevention gains in~     importance.~      The prophylactic application of antibiotics (surgical antimicrobial prophylaxis, SAP) prior~     to the skin incision significantly reduces the risk of SSI, but the correct time point of~     drug administration remains unclear. Most studies recommend application of SAP directly prior~     to skin incision. Other studies, however, suggest that this is too late and more time between~     administration of the SAP and skin incision is necessary for optimal SSI prevention. A large~     cohort study in Switzerland concluded that SAP should be applied between 74 and 30 minutes~     prior to skin incision.~      Due to the obvious importance of this controversy, we want to answer this question with a~     clinical study (randomized controlled trial, RCT) at the University Hospital of Basel and the~     Cantonal Hospital of Aarau. We plan to investigate two administration strategies according to~     the timing of the SAP. Strategy A will consist of SAP application in the anesthetic room~     located in front of the actual operating theatre, where the patient gets anesthesia.~     Therefore, the application of SAP will take place early, approximately between 75 and 30~     minutes prior to skin incision. In strategy B we will apply SAP in the operating theatre,~     which on average occurs later (approximately within the last 30 minutes before skin~     incision).~      We test the hypothesis that strategy A is more effective in preventing SSI than strategy B.~     We will include a total of 5000 patients in abdominal, vascular and trauma surgery (2500 at~     each study site and 2500 per study group). All patients will be followed in the hospital for~     SSI occurrence. Additionally, all patients will be interviewed by telephone after hospital~     discharge at a defined follow-up period of 30 days (1 year if an implant is in place, such as~     hip endoprosthesis or meshes). We expect this study to be completed within approximately 3~     years.~   "
135740|NCT01790516|"~     This study is for patients with newly diagnosed head and neck cancer that cannot be removed~     by surgery.~      The purpose of this study is to determine the feasibility of using genetic variations in~     patients to select the right drug to treat head and neck cancer. Cisplatin and cetuximab~     (Erbitux)are both approved by the FDA to treat head and neck cancer in combination with~     radiation therapy. In this study the investigators will test whether genetic differences~     between patients can be used to pick which of these two drugs a patient should receive. All~     patients will have a blood sample drawn that will be tested for genetic differences. If~     patients have genetic differences that correlate with a better outcome from cisplatin they~     will receive cisplatin with radiation. If patients have genetic differences that do not~     correlate with a better outcome from cisplatin they will receive cetuximab with their~     radiation therapy.~   "
135741|NCT01790503|"~     The study objectives are to assess the potential for PLX3397 to improve the efficacy of~     standard of care radiation therapy (RT) + temozolomide in patients with newly diagnosed~     glioblastoma (GBM).~   "
135742|NCT01790490|"~     Cocaine dependence involves problematic neuroadaptations, such as heightened reactivity to~     cocaine cues, that may be responsive to pharmacological modulation of glutamatergic circuits.~     Despite promising preclinical findings with n-methyl-d-aspartate receptor (NMDAr) modulators,~     studies with human subjects have been unsuccessful to date. The purpose of this investigation~     is to examine the effects of the NMDAr antagonist ketamine, recently found to have potent~     therapeutic effects in humans, on cue-induced craving and impaired motivation for quitting~     cocaine in cocaine dependent participants, 24-hours post-infusion.~   "
135743|NCT01790477|"~     The goal of this study is to assess the role of battlefield acupuncture in the reduction of~     pain scores status post adult tonsillectomy. Secondary goals of this study include reduction~     in narcotic usage, decreased nausea and vomiting, and evaluating patient factors that lend an~     increased risk of worsening pain or improved response with acupuncture.~   "
135744|NCT01790464|"~     Endotracheal intubation of the morbidly obese is often performed awake. This is performed~     after topical anesthesia of the patient's pharynx and larynx. There are many techniques used~     to perform topical anesthesia of the patient's airway, which include aerosolization of local~     anesthesia, topical application of local anesthesia, and nerve blockade using needles and~     local anesthesia. Reasons for failure of any awake tracheal intubation technique is excess~     gagging. The most effective method to adequately anesthetize the airway to decrease the~     amount of gagging is unknown. The investigators wish to assess if the instillation of local~     anesthesia soaked gauze next to the peritonsillar pillars will decrease the number of gagging~     episodes during awake video laryngoscopy assisted tracheal intubation of the morbidly obese.~   "
135745|NCT01790451|"~     Up to 16 patients with confirmed low- or intermediate risk prostate cancer scheduled for a~     radical prostatectomy will be asked to have the Irreversible Electroporation (IRE) procedure~     approximately 30 days prior to the prostatectomy. Ablation with IRE will be performed using~     similar planning criteria, procedure protocol, instruments and software used for~     brachytherapy, a conventional targeted radiation therapy where radioactive seeds are~     implanted into prostate tumours. Patients will have an ultrasound of the prostate and the~     imaging data will be entered into the Planning Software system. The volume of the prostate is~     measured and a specified ablation zone will be determined. The IRE will be performed under~     general anaesthetic and the specified zone identified in the planning stage will be ablated.~     Four IRE electrode needles will be placed into the prostate under ultrasound image guidance.~     When the needles are in place, electric pulses of one to two minutes duration are used to~     ablate the specified zone. The total procedure time will be approximately 1 hour. Safety data~     will be collected and patients will be followed up at 1 week, 2 weeks post IRE, pre-~     prostatectomy, post prostatectomy and 1 week post prostatectomy. The safety data collection~     is at 2 weeks post IRE. Before the IRE procedure, patients will have a Magnetic Resonance~     Imaging (MRI) and Contrast Enhanced Ultrasound (CEUS) of the prostate. The patients will have~     their scheduled prostatectomy at approximately 30 days after the IRE procedure.~     Pre-prostatectomy, the ablation zone will be radiologically assessed by a control MRI/CEUS.~     Post prostatectomy, efficacy of ablation will be determined by histological examination of~     the prostate by the Pathology Department and measured as complete or incomplete ablation.~      The primary outcome is safety as measured by the composite of procedural device and post~     procedural adverse events, measured with the Common Terminology Criteria for Adverse Events v~     4 (CTCAE), Expanded Prostate Cancer Index Composite (EPIC) score, International Prostate~     Symptom Score (IPSS) or required catheterization time and International Index of Erectile~     Function (IIEF) and efficacy of ablation determined by histological examination post~     prostatectomy. Secondary outcomes will be patients procedure satisfaction measured by patient~     satisfaction questionnaire, post procedural pain management and Visual Analogue Scale (VAS)~     pain score, time to ambulation, length of hospital stay.~   "
135747|NCT01790425|"~     This is a prospective , single center, investigator initiated, randomized controlled trial to~     compare two methods of performing colonoscopy by experienced colonoscopist. Potential female~     subjects presenting for colonoscopy at UCD GI Lab will be presented with the study option and~     will be enrolled if they sign the informed consent.~      In recent years, the water infusion method has been reported to have several beneficial~     effects when studied in veteran patients. These include: significant reduction in discomfort~     to permit a significantly higher percentage (98% vs. 76%) of veterans to complete scheduled~     unsedated colonoscopy, lower sedation medication requirement when they accepted the option of~     minimal pre-medication sedation, more patients completing without sedation (78% vs 54%) when~     they accepted the on demand sedation and an increase in the yield of adenomas (a type of~     cancer seen in the colon) in screening and surveillance colonoscopy. Reviewers of the method~     have repeatedly called for studies using the method in female patients to confirm or refute~     the findings as most of the veteran patients are male patients.~   "
135748|NCT01790412|"~     To assess the effectiveness of an exercise program developed during pregnancy (land/aquatic~     activities) aerobic and muscular tonification, on control to the prevention to Gestational~     Diabetes. And to assess if excessive maternal weight gain is an influence in the diagnostic.~   "
135749|NCT01790399|"~     The study is based on the identification of sentinel node(s) by SENTIMAG / SIENNA + in~     addition to the usual method (blue and /or radioactive product). This is a feasibility study~   "
135750|NCT01790386|"~     This study is being performed to obtain data about the CORA system, a new device that is~     currently being tested and is not yet cleared for sale in the United State by the Food and~     Drug Administration (FDA). The purpose of the study is to validate the CORA system by~     comparing the results of this test to that of the standard of care device called the TEG~     system. Both systems evaluate hemostasis, a highly complex and interactive process involving~     many protein and cellular elements, especially platelets, occurring in a series of~     interrelated phases, which results in either normal hemostasis or a tendency toward bleeding~     or clotting complications.~   "
135751|NCT01790373|"~     The goal of Suubi+Adherence is to examine the impact and cost associated with an innovative~     intervention to increase adherence to HIV treatment for HIV-infected adolescents. Multiple~     intervention studies by our team in Rakai and Masaka Districts of southern Uganda with~     AIDS-orphaned adolescents have revealed that if given an opportunity to participate in~     economic empowerment interventions, youth and their caregivers take full advantage of these~     interventions to save and invest in their future, show improvements in family financial~     outcomes, future aspirations, health functioning, sexual-risk taking behaviors, and mental~     health. The Suubi+Adherence study capitalizes on this prior work, positing that economic~     empowerment may be a missing, yet critical ingredient to HIV treatment adherence~     interventions for adolescents and young people. Suubi+Adherence incorporates an economic~     empowerment design, with a savings-led income generating component, to promote economic~     stability, and apply it to adherence to HIV treatment regimens for HIV-positive adolescents~     in a region of southern Uganda with the highest HIV incidence and prevalence in the country.~   "
135752|NCT01790360|"~     The study will seek and recruit substance-using Black Men who have Sex with Men (MSM) in New~     York City for Human Immunodeficiency Virus (HIV) testing and will link and retain those who~     are HIV infected in HIV primary care. The STAR study has two primary objectives: to evaluate~     the feasibility and effectiveness of Respondent Driven Sampling (RDS) in the substance using~     Black MSM population for identifying individuals who are HIV infected and not in care; and to~     assess the relative effectiveness of patient navigation and financial incentives in linkage~     and retention to HIV care.~   "
135753|NCT01790347|"~     An estimated two-thirds to three- quarters of women experience gestational weight gain~     outside of IOM's 2009 recommendations: 40-60% of women experiencing excessive gain and 15-30%~     inadequate gain. Not gaining the adequate weight gain is strongly associated with several~     maternal and fetal complications..~   "
135754|NCT01790334|"~     It is widely known that positive mechanical ventilation increases the positive intrathoracic~     pressure which affects the pressure in the RIJV, resulting in an increase of the CSA.~     Currently, there appears to be a lack of studies in the literature that assess the effects of~     different modes of ventilation of this increase.~      The aim of our study is to evaluate the changes in cross-sectional area and diameters of RIJV~     under two different mechanical ventilation modes (PCV and VCV) and spontaneous ventilation in~     head neutral and 30 degree rotated lateral position by using ultrasonography and to determine~     the ventilation mode that is most suitable for catheterization.~   "
135755|NCT01790321|"~     The general objective of this study is to determine the effect of the daily consumption of~     zinc-fortified water provided by the LSF-filter on zinc status and diarrhea rates in school~     age children from rural areas characterized by a high risk of zinc deficiency and by elevated~     stunting prevalence.~   "
135756|NCT01790308|"~     The purpose of this study is to investigate and evaluate the effects of liraglutide combined~     with short-term continuous subcutaneous insulin infusion(CSII) on long-term glycemic control~     and β-cell function in newly diagnosed type 2 diabetic patients.~   "
135757|NCT01790295|"~     The purpose of this study is to find out if giving the study drug Ruxolitinib (INC424) prior~     to a combination of other chemotherapeutic drugs (Fludarabine and Busulfan) before infusing~     another person's hematopoietic stem cells (bone marrow transplantation) will be successful in~     people who have advanced primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis~     (PPV-MF) or post-essential thrombocythemia myelofibrosis (PET-MF), collectively known as~     myelofibrosis (MF). MF is a disorder in which bone marrow tissue develops in abnormal sites~     because the bone marrow itself undergoes fibrosis or scarring. This study plans to evaluate~     whether adding the drug Ruxolitinib will further aid in reducing pre-transplant spleen size,~     improve physical performance levels and reduce adverse events (side effects) related to the~     transplant. Ruxolitinib is a drug that is approved by the FDA for the treatment of patients~     with advanced forms of myelofibrosis. Using Ruxolitinib prior to stem cell transplantation is~     experimental.~   "
135758|NCT01790282|"~     Study if supporting luteal phase of high responder (high egg production or high Estradiol~     level) long Gn_Rh agonist protocol ICSI/IVF cycle by combined Estradiol and progesterone~     impairs or improves outcome in terms of pregnancy and implanation rates.~   "
135759|NCT01790269|"~     Data on fingolimod effects on NK cells are so far conflicting. A longitudinal study on~     fingolimod treated kidney transplant patients showed that NK cells were not influenced in any~     of the treatment groups. However, more recent reports indicate an increased frequency of NK~     cells in peripheral blood and CSF of MS patients treated with fingolimod and a relative~     reduction of immature CD56bright NK cells in fingolimod-treated MS patients. It has been~     demonstrated that the expression of NK cell relevant sphingosine 1-phosphate (S1P) receptors~     seems to increase during NK cell maturation. Thus, different NK cell sub-types may response~     differently to S1P-receptor agonist such as fingolimod.~      Therefore, the investigators aim to investigate longitudinally (baseline vs. treatment) the~     effects of fingolimod on NK cell maturation/differentiation.~   "
135760|NCT01790256|"~     Insomnia patients demonstrate subjective and physiological hyperarousal. The Cereve Sleep~     System has been proposed as a clinical treatment to reverse this hyperarousal in insomnia~     patients. The current study is a two dose study to determine the optimal temperature for the~     Cereve Sleep System. Primary outcome measures include EEG sleep measured sleep latency and~     sleep efficiency.~   "
135761|NCT01790243|"~     The purpose of the study is to collect additional safety and efficacy information on the~     Lutonix (formerly Moxy) Drug Coated Balloon for treatment of stenosis or occlusion of the~     femoral and popliteal arteries.~   "
135762|NCT01790230|"~     A preliminary Study in Subjects Undergoing Low Anterior Resection~   "
135763|NCT01790217|"~     This observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in~     first-line therapy in patients with locally advanced or metastatic EGFR mutation-positive~     non-small cell lung cancer. Eligible patients, for whom the treating physician has decided to~     initiate treatment with Tarceva according to the local label will be followed for 18 months.~   "
135764|NCT01790204|"~     The aim of this clinical trial is to examine the effects of phenethyl isothiocyanate (PEITC),~     a compound derived from cruciferous vegetables, on oral cells with mutant p53. The p53~     protein's normal (wild-type) function within cells is to act as a tumor suppressor, or~     anti-cancer protein. When mutated, the p53 protein not only no longer executes the functions~     of a tumor suppressor, and it can gain functions as a pro-cancer protein.22 The proposed~     clinical trial will utilize oral cells collected from subjects who are heavy smokers. Since~     the subjects are regularly exposed to mutagenic chemicals it is the thought that their oral~     cells will contain measurable levels of mutant p53. The participants will consume watercress~     juice, which is rich in PEITC (See Figure 1). Previous studies in the laboratory showed PEITC~     selectively depletes mutant p53, and not wild type p53, in cell culture. Our hypothesis is~     that the ITC in the watercress juice will lead to the depletion of mutant p53 within the oral~     cells. This depletion could lead to a possible clinical application of this compound, such as~     chemopreventives or oncologic treatments of individuals with oral cancers.~   "
135765|NCT01790191|"~     This study aims at comparing learning mechanisms to increase vegetable acceptance in infants~     at complementary feeding, namely repeated exposure (RE), flavor-flavor learning (FFL) and~     flavor-nutrient learning (FNL); measuring the stability of the learning effect; and examining~     the impact of infants' feeding history on vegetable acceptance.~   "
135766|NCT01790178|"~     The objective of the proposed study is to evaluate the clinical utility of muscle~     ultrasonography for improving the diagnostic yield and safety of core muscle biopsy. Our~     facility currently uses core (needle) biopsy to obtain muscle samples in patients 18 years~     old or older. Currently, there is no imaging tool used to guide the actual biopsy. As muscle~     biopsy is an invasive and potentially painful procedure, improving the diagnostic yield of~     this test is important.~   "
135767|NCT01790165|"~     The aim of this study is to establish a clinical bridge to Lamisil® tablets by conducting a~     clinical pharmacokinetic (PK) study comparing the systemic exposure of a Lamisil® tablet with~     that of with TDT 067 under maximal use conditions.~      Under maximal use conditions in onychomycotic subjects, the aim is to confirm that there are~     significantly lower plasma levels of terbinafine and its major metabolites after a topical~     administration of TDT 067 for 28 days in comparison with a single oral 250 mg Lamisil®~     tablet.~   "
135768|NCT01790152|"~     This clinical trial studies the effects of dexrazoxane hydrochloride on biomarkers associated~     with cardiomyopathy and heart failure after cancer treatment. Studying samples of blood in~     the laboratory from patients receiving dexrazoxane hydrochloride may help doctors learn more~     about the effects of dexrazoxane hydrochloride on cells. It may also help doctors understand~     how well patients respond to treatment.~   "
135769|NCT01790139|"~     To determine whether colonic bubbles associated with CT colonography performed with iohexol~     for fecal/fluid tagging could be reduced by adding simethicone to the standard cathartic~     preparation.~   "
135770|NCT01790126|"~     The proposed clinical trial will study the effects of 12 months of therapy with ARN-509~     alone, or in combination with an LHRH agonist (LHRHa), each compared with LHRHa alone, in men~     with a rapidly rising serum PSA after prior definitive local therapy for prostate cancer. The~     endpoints selected reflect measurable short term effects of androgen deprivation therapy~     (ADT), including quality of life and several metabolic parameters. In addition, the relative~     effect of each treatment strategy on PSA suppression as well as testosterone recovery (and~     subsequent PSA progression) after 12 months of therapy will be evaluated.~   "
135771|NCT01790113|"~     A Prospective, Randomized, Multicenter Study comparing the Safety and Effectiveness of~     Arthrex's Eclipse™ Shoulder to the Univers™ II Shoulder Prosthesis in patients with a~     degenerative joint disease.~   "
135772|NCT01790100|"~     The purpose of the study is to determine the safety, pharmacokinetics and efficacy of orally~     administered VX-135 with ribavirin in treatment naive subjects with chronic hepatitis C~     infection.~   "
135773|NCT01790087|"~     This study has been designed in compliance with the ICH-E14 guideline (2005) to evaluate the~     effect of ANX-188 at therapeutic and supratherapeutic concentrations on cardiac~     repolarization, specifically, Fridericia's QT-Interval (QTcF)~   "
135774|NCT01790074|"~     It is a pilot randomized controlled trial comparing real and simulated manual treatment of~     trigger points (TrPs) in patients with cervicogenic headache (CeH). The purpose of the~     current randomized clinical pilot trial was to determine the preliminary effects of TrP~     manual therapy in individuals with CeH with sternocleidomastoid muscle active TrPs as~     compared to manual contact over the muscle tissues.~   "
135775|NCT01790061|"~     The gut microbiota is considered to constitute a microbial organ which has pivotal roles in~     the intestinal diseases and body's metabolism. Evidence from animal and human studies~     strongly supports the link between intestinal bacteria and inflammatory bowel diseases (IBD).~     Dozens of studies reported its efficacy in treatment of severe Clostridium difficile colitis.~     Preliminary studies using FMT for Ulcerative Colitis (UC), Crohn's diseases, irritable bowel~     syndrome (IBS) and constipation have also met with some success. This is an initial step into~     investigating the potential efficacy of standardized fecal bacteriotherapy through mid-gut~     (at least below duodenal papilla) for UC, the investigators propose to determine the~     efficiency and safety of FMT in a series of 500 patients with moderate to severe UC (Montreal~     classification).~   "
135776|NCT01790048|"~     This is a prospective, randomized, double-blinded, controlled clinical effectiveness trial of~     two supplementary foods in the treatment of MAM.~      Specific Aim 1: Test the effectiveness of two supplementary foods, whey RUSF and soy RUSF, in~     the treatment of MAM in 6-59 month old children in a 12-week home-based supplementary feeding~     program.~      Hypothesis: The proportion of children who recover receiving either soy or whey RUSF will~     differ by no more than three percent.~   "
135777|NCT01790035|"~     Phase 3 placebo-controlled trial to determine efficacy of the probiotic LGG for reducing~     acute treatment related GI toxicity in patients with GI malignancy with phase 1 safety~     lead-in.~   "
135778|NCT01790022|"~     In this study, efficacy of methylprednisolone in reduction of signs and symptoms (back pain,~     stiffness, joint pain and swelling) of active ankylosing spondylitis (AS) will be~     investigated. It is expected, that a single dose of methylprednisolone 500 mg given~     intravenously at baseline will lead to a rapid reduction of symptoms of active AS, which can~     be seen already 2 weeks after drug administration.~   "
135779|NCT01790009|"~     Accumulating evidence suggests that regular consumption of foods and beverages rich in~     flavanols, such as cocoa, tea, apples and wine, may have cardiovascular benefits. Several~     well-controlled randomised human intervention studies have shown that cocoa flavanols have~     beneficial effects on blood pressure, endothelial function and other biomarkers of~     cardiovascular health. These vascular improvements have been correlated in time with changes~     in plasma flavanol metabolites. The health benefits of flavanol consumption are therefore~     likely dependent on changes in their absorption, distribution, metabolism and excretion~     (ADME). Recent studies have provided detailed information regarding the absorption and~     metabolism of cocoa flavanols. However, there is a lack of information on whether there are~     changes in flavanol absorption and metabolism with increasing age.~   "
135780|NCT01789996|"~     Two - four 6MWT performed according to ATS standards. Each walk however had specifically~     altered wording and coaching performed in random order to determine differences in outcomes.~     One walk was done in the standard ATS fashion. One was done coaching to walk as fast as the~     patient can walk. One was coached to walk at the patients normal walking pace. One was~     coached to walk at the patient's leisure walking pace.~   "
135781|NCT01789983|"~     The study will look at conducting a medium-intense walking program called Walk With Ease with~     cancer patients age 60 and above who are starting chemotherapy treatment. We will measure how~     many of these patients complete their participation in this program.~   "
135782|NCT01789970|"~     The primary objective of this study is to evaluate the efficacy of hydrocodone bitartrate~     extended-release tablets at doses of 30 to 90 mg every 12 hours compared with placebo in~     alleviating moderate to severe pain in patients with chronic low back pain. Patients may be~     opioid-naïve or opioid-experienced.~   "
135783|NCT01789957|"~     This multicenter, open-label extension study of Protocol 2993-112 is designed to assess~     long-term glucose control as measured by HbA1c (glycosylated hemoglobin) and to evaluate~     long-term safety and tolerability in subjects treated with metformin who receive~     subcutaneously injected AC2993 (10 mcg) administered twice daily. Subjects completing~     Protocol 2993-112 are eligible to enroll.~   "
135784|NCT01789944|"~     To evaluate the acceptability and feasibility of peers as interventionists in delivering~     family-based behavioral pediatric weight control intervention.~   "
135785|NCT01789931|"~     CB (Chemical Biological)protective clothing provides a thermal resistance between the human~     body and its environment. CB protective clothing will be essential for combat soldiers in~     case of non conventional attacks. Lifebeam developed a new non invasive sensor for body~     core temperature detection. The research purpose is to evaluate the Lifebeam sensor during~     heat tolerance test while wearing CB protective clothing.~   "
135786|NCT01789918|"~     The ACHIEVE study is a single-arm, open-label, prospective, post-market follow-up study to~     include up to one hundred (100) eligible patients as defined within the clinical~     investigational plan, with a twelve month follow-up period. The ACHIEVE study was originally~     designed in accordance with the 2007 ESH ESC guidelines for resistant hypertension.~   "
135787|NCT01789905|"~     Secondary Data Collection Study; safety and effectiveness of Tigecycline .under Japanese~     medical practice~   "
135788|NCT01789892|"~     The purpose of this study is to determine whether giving an anti-inflammatory medication~     (corticosteroid) prior to a positron emission tomography scan (PET) scan may reduce or~     eliminate false findings related to inflammation~   "
135789|NCT01789879|"~     The use of hormone contraception poses a significant challenge for the estimated 16 million~     HIV-infected women of childbearing age. This is due to known drug interactions with~     antiretroviral therapy (medicines used to treat HIV) that may jeopardize contraception~     effectiveness. By evaluating the impact of antiretroviral therapy on a levonorgestrel~     subdermal implant, the most widely available hormone implant in low and middle-income~     countries, this study will translate its findings into an evidence-based approach to~     co-manage these important medications. The investigators hypothesize that women receiving~     nevirapine or efavirenz-based antiretroviral therapy will have a significant decrease in the~     mean levonorgestrel plasma concentration measured six months after the implant's insertion as~     compared to those women who are not taking antiretroviral therapy. Although the implant's~     efficacy may be retained initially, the investigators propose that a decrease in~     levonorgestrel concentrations in women receiving antiretroviral therapy may jeopardize the~     implant's effectiveness near the end of its intended duration of use (5 years).~   "
135790|NCT01789866|"~     Studies suggest that lutein and n-3 fatty acids may influence the development of a child's~     brain and may be related to how well children learn. Both lutein and the n-3 fats (also known~     as omega-3 fats) are not made by the body and must be obtained in the diet. The investigators~     are interested to understand the importance of n-3 fats and lutein to child brain~     development. Functional magnetic resonance imaging (fMRI) will make it possible to look into~     the brain from the outside and see which parts of the brain are being used as children~     complete working memory tasks. The investigators will study brain function using fMRI among~     children with different intakes of n-3 fats and lutein.~      Hypothesis:~        1. Children 6 years of age consuming < 25 mg/day DHA and < 400 μg lutein/day will show~          poorer activation of brain areas on fMRI than children consuming > 150 mg/day DHA and >~          1,200 μg/day lutein.~        2. Children consuming < 400 μg lutein/day and > 150 mg/day DHA will also show differences~          in fMRI results when compared to children consuming > 150 mg/day DHA and > 1,200 μg/day~          lutein.~   "
135791|NCT01789853|"~     The purpose of this study is to demonstrate the efficacy of intensive locomotor interventions~     early post stroke. An intensive locomotor training (LT) program will be compared to an active~     control, conventional physical therapy. It is proposed that an early and intensive stepping~     paradigm that is not typically employed early in physical therapy will lead to superior~     outcomes and improved community mobility. A randomized, blinded, controlled trial will test~     subjects with moderate to severe locomotor dysfunction in individuals post-stroke to compare~     walking-related outcomes after intensive gait training (including treadmill, overground,~     stair training, and skilled walking training) to outcomes after conventional physical~     therapy.~   "
135792|NCT01789840|"~     The purpose of this study is to evaluate improvement of symptoms from benign prostatic~     hyperplasia (BPH) as assessed by the International Prostate Symptom Score (IPSS) for~     prostatic artery embolization (PAE) using Embosphere Microspheres compared to conventional~     transurethral resection of the prostate (TURP).~   "
135793|NCT01789827|"~     This pilot clinical trial studies aldesleukin imaging in viewing tumor growth in patients~     with stage IV melanoma receiving ipilimumab or pembrolizumab therapy. Diagnostic procedures,~     such as single-photon emission computed tomography (SPECT), uses radioactive drugs and a~     scanner to make detailed pictures of areas inside the body and may be a less invasive way to~     check for stage IV melanoma. Radioactive drugs, such as technetium Tc 99~     hydrazinonicotinamide-tricine-linked interleukin-2, carry radiation directly to cancer cells~     and may be able to differentiate between tumor growth due to inflammation versus tumor~     progression in patients with stage IV melanoma receiving therapy.~   "
135794|NCT01789814|"~     Early stent thrombosis has been noted with increased frequency in acute coronary syndrome~     (ACS) patients undergoing percutaneous coronary intervention (PCI) who are treated with~     bivalirudin and clopidogrel. The brief half life of bivalirudin acting in concert with the~     delayed action of clopidogrel likely exposes patients to thrombosis during a vulnerable~     period of reduced antiplatelet effect in the immediate post stenting period. Combination~     therapy with bivalirudin and prasugrel is conceptually attractive as the more rapid onset of~     action of prasugrel could potentially significantly diminish the vulnerable period, likely~     reducing the potential for acute stent thrombosis. The trials which have documented the~     efficacy of prasugrel as compared to clopidogrel have, in general, not reported on patients~     in whom bivalirudin was utilized. Currently, in the United States, bivalirudin is the most~     commonly used adjunctive agent used during PCI. Using light transmission aggregometry, this~     study will examine the inhibition of platelet aggregation in patients randomized to treatment~     with clopidogrel vs prasugrel during the vulnerable period following the discontinuation of~     bivalirudin therapy. The investigators anticipate that this study will document significant~     enhancement of inhibition of platelet aggregation in patients randomized to prasugrel~     treatment.~   "
135795|NCT01789801|"~     Previous studies have demonstrated that an experienced ultrasound operator is able to~     efficiently perform radial arterial puncture on patients where an initial operator failed to~     puncture arteries via simple palpation.~      The objective of this study is to compare difficult-to-puncture patients randomized into~     two groups: one group where ultrasound is used to aid artery localisation, and one group~     where only palpation is used.~   "
135796|NCT01789788|"~     This randomized, double-blind, placebo-controlled, multiple ascending dose study will~     evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO6811135 in~     patients with type 2 diabetes mellitus. Patients will be randomized to receive either~     RO6811135 or placebo daily for 2 weeks, with a follow-up examination 2 to 3 weeks after the~     last dose of study drug.~   "
135797|NCT01789775|"~     Phase 3 efficacy and safety study of CD07805/47 topical gel in subjects with facial erythema~     associated with rosacea. The study hypothesis is that CD07805/47 gel, applied topically once~     daily is more efficacious than vehicle and provides an acceptable safety profile in the~     treatment of facial erythema associated with rosacea~   "
135798|NCT01789762|"~     This study is a multicentre, double-blind, randomized therapeutic trial.~      The primary objective of this study is to evaluate non-inferiority with regard to prevention~     and control of haemorrhage:~        -  of platelet concentrates treated by pathogen reduction(Intercept amotosalen and UVA~          procedure)~        -  compared with the usual platelet concentrates (in additive solution intersol), reference~          arm, and~        -  compared with platelet concentrates re-suspended in autologous plasma (historic arm)~          These three products are available and authorised by ANSM (formerly AFSSAPS).~      The secondary objectives is to evaluate the transfusion needs, transfusion outcomes and~     safety and the decreased frequency of grade 2 or higher side effects related to transfusion~     allergy to platelets.~   "
135799|NCT01789749|"~     Recurrence after endoscopic mucosal resection of laterally spreading lesions (LSL) >= 20mm in~     size occurs in approximately 20% of cases at surveillance colonoscopy. We aim to evaluate the~     efficacy of prophylactic adjuvant thermal ablation of the EMR mucosal defect margin in~     reducing adenoma recurrence following colonic EMR.~   "
135800|NCT01789736|"~     In the double-masked, randomized, multi-center, active-controlled parallel study, patients~     will be randomized to receive either a fixed dose combination of AR-12286 and travoprost,~     AR-12286, or travoprost. The hypothesis is that there is no difference between each treatment~     arm.~   "
135801|NCT01789723|"~     The purpose of this study is determine the optimal dose and schedule of Fusilev to prevent or~     reduce Mucositis in patients with Non-Hodgkin's Lymphoma receiving Folotyn treatment.~   "
135802|NCT01789710|"~     The purpose of this study is to examine the effectiveness of an internet-based contingency~     management program for smoking cessation in persons who are homeless. Thirty homeless smokers~     will be enrolled in the study. Participants will receive payment based on their own low~     carbon monoxide readings, which indicate being quit from smoking. Participants will be~     prescribed nicotine replacement (patches and either gum or lozenge)and bupropion. All~     participants will receive a four sessions of smoking cessation counseling, and will be~     trained to perform carbon monoxide monitoring with a device provided by the study. They will~     also be provided with a mobile phone equipped with a video camera, and will use this~     equipment at home to monitor their carbon monoxide . Participants will record videos of~     themselves taking a carbon monoxide reading and displaying the results, and will upload the~     videos to a secured website that is only accessible by the research team members and the~     participant. Payment will be based on providing carbon monoxide readings that indicate~     abstinence.~      The study is designed to address the following aims:~      Specific Aim 1: To evaluate whether it is feasible to use internet-based contingency~     management for helping smokers who are homeless stop smoking.~      Specific Aim 2: To evaluate how effective internet-based contingency managementis on~     decreasing smoking in smokers who are homeless.~   "
135803|NCT01789697|"~     The objectives of this double-blind, randomized, controlled study are to evaluate the~     efficacy of maintaining contact with low-back pain patients through text messaging and~     emailing, to decrease anxiety levels, pain, number of follow-up visits through text messaging~     and emailing, and to improve reporting of surgical site infection after spine surgery through~     text messaging and emailing. The outcomes that will be measured are anxiety, pain, follow-up~     visits and received phone calls, and reporting signs of surgical site infection. Participants~     will include Dr. Oren Gottfried's patients who underwent spine surgery at Duke Hospital or at~     Duke Raleigh Hospital. Patients will be approached after determination that the patient is~     going to undergo spinal surgery. All patients meeting inclusion criteria will be approached~     to participate irrespective of race or ethnicity. A total of 194 subjects will be recruited.~   "
135804|NCT01789684|"~     RATIONALE: Multi-faceted provider education and decision support intervention will increase~     the rate of appropriate referral of breast cancer patients at increased risk for hereditary~     breast and ovarian cancer (HBOC) to genetic counseling.~      PURPOSE: This cluster randomized controlled trial will compare active and passive~     interventions to increase the rate of appropriate genetic counseling referrals of newly~     diagnosed breast cancer patients at increased risk for HBOC to genetic counseling in the~     community oncology setting.~   "
135805|NCT01789671|"~     To evaluate the acceptability and feasibility of peers as interventionists in delivering~     family-based behavioral pediatric weight control intervention.~   "
135806|NCT01789658|"~     Oral mucositis (OM) is a common adverse effect of chemotherapy, radiotherapy and conditioning~     regimens before Hematopoietic Stem Cell Transplantation (HSCT). The aim of this study is to~     effectiveness of cryotherapy as a prophylactic treatment in children undergoing HSCT.~   "
135807|NCT01789645|"~     It is a randomized clinical trial comparing surgical and conservative (physical therapy)~     treatments for women with carpal tunnel syndrome (CTS). The purpose of the study is to~     determine the efficacy of physical therapy versus endoscopic surgery in pain and disability~     in women with carpal tunnel syndrome at medium and long-term follow-up periods. We~     hypothesized that proper physical therapy approach can be equally effective than surgical~     intervention for improving pain and function in patients with carpal tunnel syndrome.~   "
135808|NCT01789619|"~     To evaluate the clinical efficacy of the extended release formulation of tacrolimus~     (Advagraf®) in patients with severe atopic dermatitis, who can not be treated adequately with~     cyclosporine A because of side effects and/or non-responsiveness.~   "
135809|NCT01789606|"~     A self-selection and actual use trial to evaluate the extent to which consumers will~     appropriately select and use the 600 mg immediate release/extended release caplets and comply~     with dosing instructions.~   "
135810|NCT01789593|"~     This trial is conducted in Europe. The aim of the trial is to compare cognitive function and~     associated brain activation patterns during an acute hypoglycaemic episode and during~     euglycaemia (normal blood glucose concentration). Additionally, the purpose is to assess~     cognitive function in the recovery phase after hypoglycaemia or euglycaemia, respectively, in~     subjects with type 1 diabetes.~   "
135811|NCT01789580|"~     Prevalence of problem gambling is estimated about 1-3% of the general adult population. This~     percentage increases to 5% when talking about online gambling. In France, the market for~     online gambling was recently opened up to competition and regulation (May 2010), including~     poker and sports/horse races betting, but excluding for the moment casino games. Recent~     international studies show that legalizing online gambling led to an increase of practices,~     including problem gambling.~      In France, the law stipulates the establishment of moderators of online gambling, to prevent~     excessive gambling practices. The Regulatory Authority of Online Games (ARJEL) guarantees the~     implementation of these moderators. However, no evaluation of the effectiveness of these~     moderators is planned.~      Therefore the investigators propose to conduct an experimental study about online gambling.~     The objective will be to evaluate the effectiveness of four kinds of moderators, some already~     legislated, but not evaluated, and others offered by the investigators team. Proposals for~     amending legislation will be made according the results of this study.~   "
135812|NCT01789567|"~     To confirm the safety and performance of the Medtronic Engager™ Transcatheter Aortic Valve~     Implantation System via direct aortic approach.~   "
135813|NCT01789554|"~     Death from cardiac disease is one of the most common causes of death in the western world.~     The majority of these deaths takes place outside hospital as sudden cardiac death. However,~     with immediate (within minutes) actions such as cardiopulmonary resuscitation (CPR) and~     defibrillation many lives would be saved. CPR is a key factor to increase survival from Out~     of Hospital Cardiac Arrest (OHCA). CPR buys time by supporting the brain with some~     circulation in waiting for a defibrillator that can restart the heart. In Sweden about 2,5~     million people are trained in CPR. However, only about half of all OHCA victims will get CPR~     in waiting for ambulance arrival.~      The aims of the Response to Urgent Mobile message for Bystander Activation (RUMBA) trial is~     to try a new way of logistics to increase bystander CPR by recruiting lay volunteers to~     nearby OHCAs via their mobile phones.~      Hypothesis: By dispatching lay volunteers to nearby OHCAs with mobile phone technology~     bystander CPR may increase from 50% to 62,5 %~   "
135814|NCT01789541|"~     Overt hyperthyroidism (so-called goiter in lay language) is a hormonal disturbance that is~     known to increase the risk of atrial fibrillation (a common heart arrhythmia with potentially~     severe consequences) in some patients. Previous research has indicated that even slight~     elevations in thyroid hormone levels - so called subclinical hyperthyroidism - may increase~     this risk. When atrial fibrillation and overt hyperthyroidism are found simultaneously in a~     patient, the hormonal imbalance must be treated first in order to later resolve the~     arrhythmia. It is unclear whether this strategy holds true for subclinical hyperthyroidism.~     Our two hypotheses are: 1) Subclinical hyperthyroidism is more prevalent in patients admitted~     for atrial fibrillation ablation than in the population as a whole, and 2) Patients with~     subclinical hyperthyroidism and atrial fibrillation benefit less from ablation than others.~      As a control group, we have chosen patients admitted for ablation of AV-nodal Reentry~     Tachycardia at the same clinics as the cases. No correlation has ever been shown between~     AV-nodal Reentry Tachycardia and hyperthyroidism.~   "
135815|NCT01789528|"~     The purpose of this study is to investigate the effect of administration of CAZ-AVI and CXL~     on the intestinal flora of male and female healthy volunteers after multiple administrations~     over 7 days. An assessment of the effect on intestinal flora is an important aspect to~     understand for the safe clinical use of the investigational products and is expected by~     regulatory agencies.~   "
135816|NCT01789515|"~     In an attempt to reduce the risk for anastomotic leakage after low anterior resection it is~     common to create a diverting stoma at the same procedure. Several studies have shown that~     ERAS (Enhanced Recovery After Surgery)application reduces the risk of surgical stress and~     postoperative complications after major colorectal surgery. The aim of this study is to~     evaluate wether a diverting stoma, after low anterior resection for rectal cancer, affects~     postoperative morbidity in patients treated within an ERAS program.~   "
135817|NCT01789502|"~     This study is a prospective, randomized study to compare of outcome of fully covered metal~     stents with that of plastic stents for preoperative biliary drainage in distal common bile~     duct cancer, pancreas head cancer or ampullary cancer with respect to the incidence of~     stent-related adverse events, the re-intervention rate, the effectiveness of biliary~     drainage, surgical outcomes and hospital stays.~   "
135818|NCT01789489|"~     To prove that the 3 dimensional sonohysterography is, at least, as effective as the~     diagnostic hysteroscopy in examining the uterine cavity.~   "
135819|NCT01789476|"~     This is a single-center, randomized, double blind, placebo controlled, parallel group proof~     of concept study to evaluate the analgesic efficacy as well as the safety, tolerability and~     pharmacokinetic profile of CR845 in patients with pain following bunionectomy surgery.~   "
135820|NCT01789463|"~     Multicenter randomised study, on parallel groups to compare recovery of functional amplitude~     following shoulder dilatation with auto rehabilitation in one group and physiotherapy in the~     other group.~   "
135821|NCT01789450|"~     The purpose of this study is to evaluate the feasibility and sensitivity of nipple-areolar~     complex (NAC) prospectively due to the section of the dermis after decortication~     (Schwartzmann's maneuver), in 50 patients undergoing breast reduction surgery.~   "
135822|NCT01789437|"~     to evaluate the wall-to-lumen ratio (WLR) of retinal arterioles in hypertensive patients with~     retinal vein occlusion (RVO) before and after dexamethasone intravitreal implant 0.7 mg (DEX)~     compared to a matched control group of normal eyes in non-hypertensive subjects.~   "
135823|NCT01789424|"~     Aim of this study is to evaluate swallowing functionality in patient sedated for~     gastroenteric endoscopic procedure.~      Swallowing will be study by laryngeal fibroscopy and evaluate using Penetration-Aspiration~     Scale and Aspiration Risk validated in scientific literature.~      Aim of the study is to describe swallowing, as an expression of airway protection, in sedated~     patient. in particular, our purpose is to determine the incidence of moderate-severe and~     severe swallowing alteration (level 3 or 4 of Aspiration Risk scale).~   "
135824|NCT01789411|"~     The AtheroRemo-IVUS study aims to investigate the relation of coronary plaque phenotype and~     vulnerability as determined by intravascular ultrasound and near infrared spectroscopy with~     genetic profile and novel circulating biomarkers. AtheroRemo-IVUS is a prospective,~     observational, cohort study of patients who underwent coronary catheterization for acute~     coronary syndrome or stable angina pectoris. Prior to the catheterization procedure, blood~     samples were drawn for biomarker measurements and genetic analyses. Subsequent to the~     catheterization procedure, intravascular ultrasound is performed in a non-culprit coronary~     artery. In patients who are also participating in the AtheroRemo-NIRS substudy, near-infrared~     spectroscopy is additionally performed in the same non-culprit vessel. Primary endpoint is~     the presence of vulnerable plaque as determined by intravascular ultrasound. Secondary~     endpoint is long-term incidence of major adverse cardiac events. Results from AtheroRemo-IVUS~     are expected to improve our knowledge on the role of genetic profile and inflammation in the~     development of atherosclerosis and vulnerable plaques. Furthermore, novel biomarkers and~     intracoronary imaging techniques will be validated in this study.~   "
135825|NCT01789398|"~     This is a multicentric international phase III, double blind randomized study assessing~     efficacy and safety in parallel group of BF2.649 (pitolisant) compared to placebo in add-on~     to sodium oxybate of narcoleptic patients with residual Excessive Daytime Sleepiness (EDS)~     during 8 weeks~   "
135826|NCT01789385|"~     Deep brain stimulation for the treatment of Parkinson's disease has unique surgical stages~     and anesthesia needs. In the first stage the electrodes are inserted in the targeted brain~     areas and in the second stage the pulse generator is implanted. The technique for~     establishing sedation and analgesia for functional neurosurgery may differ among~     institutions. In this study it was aimed to investigate our anesthesia methods,~     intra-operative adverse events in the first stage of deep brain stimulation and the post~     operative pain therapy of the patients.~   "
135827|NCT01789372|"~     The purpose of this study is to determinate if mediyoga has effects in quality of life, heart~     rate variability, blood pressure , heart rate in patients with paroxysmal atrial fibrillation~     (PAF).~   "
135841|NCT01789190|"~     In diabetes, the honeymoon period is characterized by the presence of a functional reserve of~     β-cells that favours an adequate metabolic control and low insulin needs in order to control~     glycaemia. Therefore, the extension of this period could have evident benefits in diabetes~     management. The investigators aimed to study the influence of regular physical activity on~     the prolongation of the honeymoon period~   "
135828|NCT01789359|"~     Essentially all of the published data on anthocyanin absorption in humans are from short term~     studies - a few days or less, most typically 24 h. However human studies demonstrating~     clinical effects are typically conducted for several weeks or even months. To examine how~     anthocyanin absorption and metabolism may be affected this study will examine urinary~     excretion of anthocyanins over one month, followed by a one week washout, and then one more~     dose of blueberry juice.~   "
135829|NCT01789346|"~     The purpose of this study is to evaluate the safety and efficacy of the 532nm potassium~     titanyl phosphate (KTP) laser in comparison with the 595nm pulsed-dye laser (PDL) for the~     treatment of fresh surgical scars.~   "
135830|NCT01789333|"~     The purpose of the study is to see if brighter lights will allow for shortening of the~     treatment time required to stabilize the eyes of patients with keratoconus or a bulging~     cornea. The investigators will be comparing the therapeutic effects of two different higher~     brightnesses of ultra violet light on a riboflavin treated eye. One light will be twice as~     bright as the other and the exposure time of these brighter lights to deliver equivalent~     energy to the cornea will be reduced from the standard 30 minutes to 10 and 5 minutes.~     Riboflavin is vitamin B2 and the investigators are trying to determine if an identical~     clinical effect can be achieved the brighter treatment lights are used for shorter times. The~     investigators will also monitor the clinical effect and the status of the cornea to see if~     additional risks are associated with the brighter light.~   "
135831|NCT01789320|"~     This study is designed to determine the safety and tolerability of a single microinjection of~     triamcinolone acetonide (TRIESENCE®) into the suprachoroidal space (SCS) of patients who have~     non-infectious uveitis.~   "
135832|NCT01789307|"~     Lactose, one of the key nutrients in human milk may be critically important to infants for~     more reasons than being a source of energy. We are interested in understanding how lactose~     when compared to other sugars influences how nutrients, specifically macronutrients are~     handled after digestion and absorption. To date, there have been no studies looking at how~     fat and protein varies when lactose compared to other sugars is ingested. There may be~     metabolic advantages to considering lactose for nutrition support of premature infants rather~     than glucose or dextrose as is often used in intravenous feeds, or the corn syrup solids in~     lactose-free formulas. We hope the information from this study will provide new information~     on the unique aspects of lactose.~      Hypothesis: The hypothesis is that providing carbohydrate as lactose:~        1. minimizes the amount of carbohydrate that is converted into fat~        2. enables a relatively constant metabolic state throughout feeding interval that avoids~          swings of high to low insulin, glucose, and fats.~   "
135833|NCT01789294|"~     Aim of this prospective, parallel multi-arm, randomized, clinical trial, was to compare the~     clinical outcome of patients Methods.We recruited children who undergone diagnostic~     colonoscopy in Umberto I Pediatric Department (Rome, Italy) from 2008 to 2010. Eligibility~     criteria were: 1) only demonstration of LNH; 2) no concomitant disease; 3) no treatment~     assumed since the clinical onset. Patients were allocated 1:1:1 to dietetic (Group A) vs~     mesalamine (Group B) vs no treatment (Group C) for a 8-weeks period. Skin prick tests and~     patch test for common foods, and symptoms scoring at baseline and follow up have been~     performed by blinded clinicians. Chi-square test for trend was used to compare the frequency~     of symptoms score improvement (>1 point) among groups. The association of baseline features~     of patients with the clinical response was estimated by frequency analysis.~   "
135834|NCT01789281|"~     Study to allow access to everolimus for patients who are on everolimus treatment in a~     Novartis-sponsored study and are benefiting from the treatment as judged by the investigator~   "
135835|NCT01789268|"~     This clinical study will investigate the relationships between sequential respiratory viral~     infections, patterns of intestinal and respiratory bacterial colonization, and adaptive~     cellular immune phenotypes which are associated with increased susceptibility to respiratory~     infections and long term respiratory morbidity in preterm and full term infants. This is a~     prospective, cohort study, enrolling at a single center via two sites (URMC and~     URMC-affiliated Highland Hospital and Rochester General Hospital). Enrollment will be~     accomplished in approximately 15 - 36 months. The study will enroll 280 subjects, 150~     pre-term and 130 full-term.~   "
135836|NCT01789255|"~     This pilot phase II trial studies how well giving vorinostat, tacrolimus, and methotrexate~     works in preventing graft-versus-host disease (GVHD) after stem cell transplant in patients~     with hematological malignancies. Vorinostat, tacrolimus, and methotrexate may be an effective~     treatment for GVHD caused by a bone marrow transplant.~   "
135837|NCT01789242|"~     This is a dose finding study to evaluate the safety and determine the maximum tolerated dose~     of carfilzomib in patients with previously treated systemic light-chain amyloidosis.~   "
135838|NCT01789229|"~     Establishment of a tumor bank, consisting of tissue samples of tumor patients (benign and~     malign tumors) and healthy people as controls. The tissue samples will be collected~     systematically together with the corresponding clinical data. The biological samples, the~     clinical date together with prospective experimental date constitute the entity of the tissue~     tumor bank.~      This tumor bank for tissue samples, together with our tumorbank for blood samples~     (NCT01763125) combined constitute the entity Tumorbank.~   "
135839|NCT01789216|"~     The purpose of this study is to definitively resolve questions regarding the use of~     multimodal pharmacologic pain management for orthopedic trauma patients in the context of a~     multicenter, randomized clinical trial.~      Also, as a significant proportion of this population develops chronic post traumatic~     osteoarthritis (PTOA), a sub-objective of this study is to examine the etiology and incidence~     of chronic pain and PTOA in this population.~   "
135840|NCT01789203|"~     BK infection is an important cause of graft dysfunction and graft loss after renal~     transplantation. It has been widely accepted that emergence of BK virus correlates with the~     more potent immunosuppressive agents used to lower acute rejection rates. In contrast to~     other opportunistic infections after transplantation, for which routine prophylactic agents~     are administered, there is no effective agent for the prevention of BK infection. Some data,~     however, suggests that quinolone antibiotics such as ciprofloxacin may have activity against~     BK virus. This has led us to investigate whether routine, short-term ciprofloxacin~     administration post-transplant can lower the incidence of BK infection.~   "
135844|NCT01789151|"~     Preliminary data following a pilot study from our institution confirms the ability of~     99mTc-glucosamine (99mTc-ECDG) to differentiate between active, subclinical and quiescent~     disease in patients with rheumatoid arthritis, scleroderma lung, and vasculitis. We propose~     to extend these findings and further evaluate this imaging modality for its clinical utility,~     limitations, and application.~      An unacceptably high level of morbidity exists amongst patients suffering from rheumatic~     disease. This is often the result of mild disease being missed or misdiagnosed, and therapy~     inordinately delayed or inappropriate. The currently used therapeutic agents themselves have~     associated side-effects adding to unfavourable clinical outcomes. There is therefore a need~     for a superior, less expensive and more easily accessible imaging modality to assess the~     degree of inflammation to guide the clinician. Glucosamine is absorbed and metabolised in a~     manner not too dissimilar to that of glucose, and it can be readily labelled to form~     99mTc-ECDG. Scans can be acquired within 3 hours of intravenous administration of this agent,~     accurately depicting sites of active inflammation/disease.~      HYPOTHESIS Glucose is a vital cellular substrate that accumulates at inflamed tissues because~     of the greater metabolic needs of the cells during active disease. Glucosamine, being an~     analogue of glucose, is metabolised more quickly in inflamed than non-inflamed tissue and~     thus 99mTc-ECDG scintigraphy like 18-Fluorodeoxyglucose (18FDG-PET) scintigraphy allows for~     detection of active inflammation. Unlike current bone scans this agent has the sensitivity to~     detect subclinical inflammatory disease that would in turn provide essential information to~     ensure accurate diagnosis and treatment.~   "
135845|NCT01789138|"~     The specific aim of the study is to assess antiretroviral therapy adherence and evaluate the~     impact of a situated treatment adherence intervention program among persons living with~     HIV/AIDS on antiretroviral therapy in Estonia.~   "
135846|NCT01789125|"~     The primary aim of this research study is to enhance smoking cessation outcome among smokers~     with anxiety disorders. We are comparing two group treatment approaches: (1) An~     educational-supportive psychotherapy and standard smoking cessation treatment, and (2) An~     integrated smoking cessation and anxiety treatment program (START). Both treatments also~     utilize nicotine replacement therapy.~   "
135847|NCT01789112|"~     Electric stimulation by cardial contractility modulation (CCM)to improve contractility and~     physical capacity~   "
135848|NCT01789099|"~     In this study, up to 21 patients with lung cancer will receive UV1 (a therapeutic synthetic~     peptide vaccine) at different dose levels. The safety and tolerability of UV1 as well as~     immunological response will be assessed. The purpose of this study is to select a biological~     dose of peptides for further clinical trials. Study recruitment completed at 6 patients in~     every dose level.~      The main study treatment phase of this study is completed and will be reported separately.~      Follow-up is ongoing~   "
135849|NCT01789086|"~     This trial is conducted in Europe. The purpose of the trial is to assess safety, tolerability~     and pharmacokinetics (the exposure of the trial drug in the body) of liraglutide in obese~     adolescent subjects aged 12 to 17 years.~   "
135850|NCT01789073|"~     The purpose of this study is to investigate the effect of preoperative immunonutrition on~     complications and length of hospital stay in patients with pancreatic cancer undergoing~     elective surgery.~   "
135851|NCT01789060|"~     PI3K(phosphatidylinositol 3-kinase)/AKT pathway is an important oncogenic signaling pathway.~     However, clinical information about the significance of p-AKT expression in malignant~     lymphoma is not fully understood yet. In this study, we investigated the overexpression of~     p-AKT and its prognostic implication in malignant lymphoma.~   "
135852|NCT01789047|"~     The study will involve an eighteen-week, double-blind, placebo-controlled parallel designed~     comparison between add-on topiramate and add-on placebo to stable treatment with amatadine in~     the treatment of PD patients who continue to have dyskinesia on amantadine.~   "
135853|NCT01789034|"~     A prospective observational study on predictors available and on variables of difficult~     intubation adopting Gliscope video laryngoscope routinely.~      Primary hypothesis of the current study is that the rate of difficult intubation with~     Glidescope is low and multiple predictors interact favorably in anticipating difficulties.~   "
135854|NCT01789021|"~     In this clinical trial, accuracy evaluation of Bayer Contour XT blood glucose monitoring~     system and blood glucose monitoring systems from other companies across the overall tested~     glucose range will be performed.~   "
135855|NCT01789008|"~     Alcoholic liver disease is the most frequent complication of excessive alcohol consumption.~     Early diagnosis of alcoholic liver disease is essential to avoid its complications that could~     be fatal. To date, the reference diagnostic tool is an invasive procedure: the liver biopsy.~     The transient elastography is a useful tool for early diagnosis of liver fibrosis. This tool~     is validated in the diagnosis of liver fibrosis due to C chronic hepatitis. Because it is~     non-invasive, fast, given immediate results; transient elastography could be repeated in~     alcoholic patients for liver fibrosis follow-up. In the present study, the investigators~     propose to realize liver biopsy and transient elastography in 300 alcoholic patients in~     weaning to evaluate the transient elastography accuracy in the exclusion of sever liver~     fibrosis (Metavir 3 and 4). The reference liver fibrosis diagnosis tool will be the liver~     biopsy.~   "
135856|NCT01788995|"~     This non-interventional study will evaluate the routine use and the safety and efficacy of~     Avastin (bevacizumab) as first-line treatment in patients with advanced ovarian cancer~     (epithelial ovarian cancer, fallopian tube carcinoma, primary peritoneal carcinoma). Newly~     diagnosed patients who are initiated on carboplatin/paclitaxel chemotherapy in combination~     with Avastin will be followed for up to 15 months of treatment and 12 months of follow-up.~   "
135868|NCT01788839|"~     The purpose of this study is to see how cancer treatment affects sexual and reproductive~     function. The patient will also be asked to participate in blood draws to see if and how~     cancer treatment affects the ovaries and the ability to have children (fertility). These~     blood draws are optional and the patient can still participate in the questionnaire portion~     of the study even if they choose not to have their blood drawn.~   "
136025|NCT01786746|"~     The goals of this study were to a) test whether cognitive behavioral therapy (CBT) is~     effective in treating depressed Chinese Americans, b) to develop and test the effectiveness~     of culturally adapt CBT, and c) to test the differential outcomes of the two treatments.~   "
135857|NCT01788982|"~     For the treatment of thyroid cancer with the so called targeted therapy the angiogenesis~     pathway has several potential targets. The Receptors for Vascular endothelial growth factor~     (VEGF) and especially VEGFR-2 is considered to be crucial for the initiation of the formation~     as well as the maintenance of tumor vasculature.~      In thyroid cancer these VEGF receptors (VEGFR-1, VEGFR-2), VEGF itself and receptors of the~     fibroblast growth factor (FGF) and for the platelet-derived growth factor (PDGF) are often~     overexpressed. Other cells as pericytes and smooth muscle cells that are also involved in~     tumor angiogenesis express these receptors as well.~      Inhibitors of the VEGFR or PDGFR pathway have been tested in thyroid cancer with positive~     results. However there is no treatment that is generally considered as standard of care for~     patients with differentiated thyroid cancer (DTC) or medullar thyroid cancer (MTC) who have~     progressed on one line of therapy. The classical cytotoxic chemotherapy has not shown a~     clinically meaningful benefit yet.~      Nintedanib is a triple angiogenesis inhibitor which inhibits receptors of VEGF, FGF and PDGF.~     Therefore it might act not only on endothelial cells but also on pericytes and smooth muscle~     cells. Nintedanib also interacts with other kinases such as RET. Because of this multi-kinase~     activity rationale exists to investigate the effect in MTC and DTC.~      Because it targets these three major angiogenesis signaling pathways it might prevent further~     tumor growth and related tumor escape mechanisms. Therefore nintedanib may be active in~     patients who have progressed on agents that target only one pathway.~   "
135858|NCT01788969|"~     The manifestation of weakness and involuntary reflexes following motor incomplete spinal cord~     injury (SCI) may be partly a result of damage to descending pathways to the spinal cord that~     release serotonin. In models of SCI, for example, application of agents that simulate~     serotonin has been shown to modulate voluntary motor behaviors, including augmentation of~     walking recovery. In humans following neurological injury, the effects of 5HT agents are~     unclear. Few previous reports indicate improved motor function following administration of~     agents which enhance the available serotonin in the brain, although some data suggests that~     decreased serotonin may be beneficial. In this application, the investigators propose to~     study the effects of clinically used agents that increase or decrease intrinsic serotonin~     activity in the brain on strength and walking ability following human motor incomplete SCI.~     Using detailed electrophysiological recordings, and biomechanical and behavioral measures,~     the investigators will determine the effects of acute or chronic doses of these drugs on~     voluntary and involuntary motor behaviors during static and dynamic conditions. The novelty~     of this proposed research is the expectation that agents that enhance serotonin activity may~     increase abnormal reflexes in SCI, but simultaneously facilitate motor and walking recovery.~     Despite potential improvements in voluntary function, the use of pharmacological agents that~     may enhance spastic motor behaviors following SCI is in marked contrast to the way in which~     drugs are typically used in the clinical setting.~   "
135859|NCT01788956|"~     The intent of this study is to validate the venous blood oxygenation measurements of the~     Mespere VA Oximeter compared to the saturations measured by venous blood sampling through an~     inserted central vein catheter, which is currently the standard of care for measuring SvO2~   "
135860|NCT01788943|"~     The investigators propose to use positron emission tomography (PET) imaging to determine~     whether nicotinic receptor availability at pretreatment predicts smoking cessation success.~     The investigators will recruit 30 smokers from those enrolled in the Pharmacogenetics of~     Nicotine Addiction Treatment clinical trial. The investigators will measure nicotinic~     receptor availability using the PET radioligand 2-[18F]FA, after overnight abstinence and~     prior to initiation of treatment.~   "
135861|NCT01788930|"~     Type-2 Diabetes and Sleep Apnea Syndrome (SAS) are both related to an increase in platelet~     activation. Type 2 diabetes is often associated with sleep apnea syndrome with a prevalence~     up to 60%.~      The main objective of our study is to analyze the influence of sleep apnea on the response to~     antiplatelet therapy in stable aspirin-treated type-2 diabetes patients.~      Consecutive stable aspirin-treated type-2 diabetes patients referred for suspicion of sleep~     apnea will be recruited after providing informed consent. Response to aspirin will be~     assessed with the Verify Now Aspirin(TM)rapid analyser in the morning after nocturnal~     polysomnography, and compared with a group of type-2 diabetes free of sleep apnea. Other~     endocrine, metabolic, hematologic and cardiovascular confounders will also be assessed at~     baseline to determine their influence on the response to aspirin.~      Then, Patients with severe SAS (Apnea-Hypopnea Index> 30 events/h) and response with Aspirin~     (ARU > 454) will be randomized to 3 months of active or sham continuous positive airway~     pressure treatment in a pilot study. After the 3-months of intervention, response to aspirin~     will be compared between the sham and effective CPAP groups.~   "
135862|NCT01788917|"~     The study was performed to investigate the effects of a daily consumption of linseed oil on~     fatty acid distribution in plasma and red blood cell lipids and blood lipids in vegetarians.~   "
135863|NCT01788904|"~     In the FARAMIS study, we aim to investigate the longitudinal course of intestinal plasma~     fatty acid binding protein (i-FABP) in patients with acute mesenteric ischemia (AMI)~     undergoing primary percutaneous angiographic intervention.~      The investigators postulate that patients with fully re-established intestinal blood flow and~     vital intestines will display a significant drop of plasmatic i-FABP within 24 hours, while~     patients requiring subsequent intestinal resection due to irreversible bowel necrosis will~     not.~      If true, patients requiring laparotomy and bowel resection could be identified and patients~     in whom angiographic intervention led to successful cure of disease would not be exposed to~     potentially perilous surgery.~   "
135864|NCT01788891|"~     This study will help identify which ARV candidates should be prioritized for pediatric use in~     resource-limited settings~   "
135865|NCT01788878|"~     The aim of this study is to explore the main factors associated with the return to work of~     patients presenting an upper aero-digestive tract cancer.~   "
135866|NCT01788865|"~     The purpose of this study is to evaluate Efficacy and Safety of a covered self-expandable~     dual-layered metallic mesh stent (UVENTA) in ureteral obstruction.~   "
135867|NCT01788852|"~     This study will assess the prevalence of HPV infection in perinatally HIV-infected~     adolescents, intraepithelial neoplasia, and E6E7 biomarker at cervical and anal sites.~   "
145566|NCT01661803|"~     The investigators can summarize intrathecal clonidine can potentiate bupivacaine thereby~     bringing about better quality and longer duration of analgesia, better sedation and better~     postoperative outcomes with minimal side effects.~   "
135869|NCT01788826|"~     The incidence of ventral hernias has remained inappropriately high. Any innovation in order~     to reduce this incidence would be simply cost-effective. Although there is still some concern~     about the use of mesh in clean-contaminated or contaminated surgery, based in our~     experimental studies, we plan to use a mesh in the primary closure of abdominal incision to~     prevent incisional hernias.~      The investigators propose a clinical trial to assess a model to prevent the incisional hernia~     after laparotomy to treat colorectal carcinoma is scheduled. A simple randomization is~     scheduled: in the intervention group a prefascial large-pore low-weight 5 cm wide~     polypropylene mesh is fixed covering the midline closure; in the control group a conventional~     closure with a running suture of long-term absorbable material with a suture/wound length~     ratio 4:1. The sample size was calculated with an estimated incidence of ventral hernia of~     25% in the control group and 10% in the intervention group, 0,05 alfa and a 0,15 beta error.~     The main goal is the appearance of a ventral hernia after 24 months of follow-up. Other~     outcomes are wound complications and morbidity. Exclusion criteria are adult patients with a~     previous ventral hernia, estimated survival of less than 6 months or hemodynamic instability~     during surgery.~      The diagnosis of ventral hernia will be assessed by clinical exploration on 3,6,12,18 and 24~     months and abdominal CT controls at 6,12, and 24 months. The study will be statistically~     evaluated with SPSS 18.0.~   "
135870|NCT01788813|"~     The purpose of this study is to examine the safety and effects on the immune system of~     treatment with GSK2245035 in subjects who suffer from nasal symptoms caused by an allergy to~     pollen or perennial allergen, with or without mild asthma. In addition, the effect of~     treatment with GSK2245035 on the body's allergic response in test situations will be~     explored. Approximately 28 subjects will receive GSK2245035 (up to 14 subjects each receiving~     80 nanograms [ng] GSK2245035 and up to 14 subjects each receiving 20 ng GSK2245035) and 14~     subjects will receive the dummy drug (placebo) during the study. Assignment of a subject to~     GSK2245035 or placebo will be done by chance, like flipping a coin. Neither the subjects nor~     the clinic staff will know whether a subject is being dosed with GSK2245035 or placebo during~     the course of the study. The study will include (a) Screening phase where the eligibility of~     subjects for enrolment will be assessed (b) Treatment phase during which subjects will~     receive either 8 nasal sprays of GSK2245035 80 ng or a matching placebo once weekly for 8~     weeks (each dose will be split between the two nostrils). Subjects participating in this~     study in 2014 will receive a reduced dose of 20 ng i.n. of GSK2245035 once weekly for eight~     administrations (c) Follow-up period where any GSK2245035 induced changes to the immune~     system and the effect of treatment on the body's allergic response in test situations will be~     monitored. The maximum planned study duration for all subjects, including the screening,~     treatment and follow-up periods, is approximately 180 days.~   "
135871|NCT01788800|"~     Physical activity (treadmill) supports the effect of cognitive behavioural therapy in~     patients with panic disorder with/without agoraphobia~   "
135872|NCT01788787|"~     The goal of this behavioral research study is to learn about the outcomes of smoking~     cessation treatment. Researchers want to learn how many smokers stopped smoking after taking~     part in smoking cessation treatment with the Texas Quitline.~   "
135873|NCT01788774|"~     This clinical trial is designed to evaluate different dosages of risperidone ISM, a new~     long-acting injectable form.~   "
135874|NCT01788761|"~     This is a research study that will look at the effects of giving two nutritional supplements~     on extremely low birth infants (infants weighing less than 1000 grams or weighing less than~     approximately 2 lbs 3 1/2 ounces at birth). The nutritional supplements that will be studied~     are Culturelle for Kids/Culturelle Kids and Align. They are nutritional supplements that each~     contain a different probiotic. In this study the investigators will mainly be looking at the~     effect that these supplements may have on how well babies tolerate their feedings and how~     long they require supplemental intravenous fluids for nutritional support. The investigators~     will also, however, look at many other factors such as rate of growth, rates of infection,~     survival rate and the length of time the infant needs to be in the hospital. The~     investigators will also look at its effect on conditions/complications of prematurity such as~     bronchopulmonary dysplasia and chronic lung disease (chronic diseases of the lung associated~     with prematurity), necrotizing enterocolitis and intestinal perforations (serious diseases of~     the infant's intestines), retinopathy of prematurity (eye disease associated with~     prematurity), intracranial hemorrhage (bleeding into the brain) and patent ductus arteriosus~     (a blood vessel connecting two main blood vessels coming out of the heart that does not close~     spontaneously (by itself).~   "
135875|NCT01788748|"~     This is an interventional open prospective randomized study, done in two sites.~      The main purpose of this study is to evaluate the efficacy of the combination of bipolar~     radiofrequency potentiated by an infrared light followed by fractional bipolar radiofrequency~     for the treatment of striae on the abdomen.~      In order to have a more complete and accurate study, each technology will also be evaluated~     separately. This will allow the comparison of the effect of each treatment, in monotherapy or~     combined.~   "
135884|NCT01788631|"~     This research study is a Phase II clinical trial, which tests the safety and effectiveness of~     an investigational drug called Regadenoson (or Lexiscan) to learn whether the drug works in~     treating a specific disease, in this case Sickle Cell Disease (SCD). Investigational means~     that the drug is being studied. It also means that the FDA has not yet approved the drug for~     your type of disease.~      SCD is an inherited blood disorder that causes the red blood cells to change their shape from~     a round shape to a half-moon/crescent or sickled shape. People who have SCD have a different~     type of protein that carries oxygen in their blood (hemoglobin) than people without SCD. This~     different type of hemoglobin makes the red blood cells change into crescent shape under~     certain conditions. Sickle-shaped cells are a problem because they often get stuck in the~     blood vessels blocking the flow of blood, and cause inflammation and injury to important~     areas in the body.~      Regadenoson (trade name Lexiscan) is a drug that may prevent this inflammation and injury~     caused by the sickle shaped cells. This drug is approved by the FDA to be used as a fast~     infusion during a heart stress test in people who are unable to exercise enough to put stress~     on their heart by making the heart beat faster. Regadenoson has been studied as a long~     infusion at this dose in adults, and no safety issues have been identified~     (ClinicalTrials.gov Identifier: NCT01085201). This is the first study to look at patient~     benefit with the long infusion of the drug. This drug has been used in laboratory experiments~     and information from those other research studies suggests that this drug may help to protect~     the body from damage caused by sickle-shaped cells in this research study.~      In this research study, the investigators are specifically looking to see if Regadenoson is~     an effective treatment for pain crises and acute chest syndrome in SCD.~   "
135885|NCT01788618|"~     Our study aims to measure the impact of cognitive rehabilitation workshops on the development~     of cognitive functions and quality of life of patients expressing a cognitive complaint~   "
135876|NCT01788735|"~     Unexplained infertility is defined as the lack of thec ability to become pregnant during the~     first year, although the periods of the woman, the semen from the man and the laparoscopic~     findings are normal. In Denmark do roughly every fifth to seven couple in the fertile age~     have problems becoming pregnant for a various kind of reasons, of these are 10-15 %~     unexplained infertile.~      Many factors are pointed out as imported. In particularly lifestyle factors such as the diet,~     smocking, obesity, lack of physic activity and alcohol. The causal connection is yet to be~     found, but it is assumed that there is a link between infertility and endocrine, neurological~     and immunological factors.~      Asthma and allergy are some of the most common diseases among young people in western world~     .The development of these diseases are caused by both hereditary factors, and factors that~     also seem to be important in infertility.~      It is clinically observed that many unexplained infertile patients simultaneously suffer from~     asthma and allergy. Furthermore this group of patients seems harder to treat in terms of~     becoming pregnant during fertility treatment then healthy not asthmatic and non allergic~     persons.~      There is limited available data about this subject and the data that is already collected~     does not show a clear tendency.~      Hypothesis: Atopic asthma is characterized by a systemic inflammation and can therefore be~     the reason for infertility among this group of patients.~      The aim:~      The aim of this study is to examine whether female asthmatics and allergic are less fertile~     then healthy females- whether there is there a link between asthma and infertility.~     Furthermore if an optimal asthma treatment during fertility treatment reduces time to~     pregnancy.~   "
135877|NCT01788722|"~     The objective of the study is to investigate and collect post marketing data on the safety~     and efficacy of Visanne at follow-up visit after about 6 months of treatment and - for a~     subset of patients - at optional long-term follow-up visit after about 1 year of treatment~     under daily practice treatment conditions in Korean women and to obtain data on drug~     utilization on treatment for endometriosis.~   "
135878|NCT01788709|"~     The colonoscopy accuracy and safety depend on the quality of colon cleansing. An inadequately~     prepped bowel will increase the risk of missing a lesion, prolong procedure, increase patient~     discomfort, and eventually increase complication rate. Therefore an excellent colon cleansing~     is of extreme importance to the endoscopist and the patient.~      Split Fortrans® prep with sugar-free mentholyptus drops (Halls®) has a better palatability~     and tolerability than the reduced volume ascorbic acid-supplemented PEG-electrolyte~     (MoviPrep®) in bowel cleansing for colonoscopy.~   "
135879|NCT01788696|"~     The purpose of this study is to evaluate the impact of imaging the brain as a diagnostic tool~     in the management of early Parkinson's disease (PD).~   "
135880|NCT01788683|"~     The primary objective of this study is to compare the improvement in subject-reported~     clinical outcomes, for Regenexx SD treatment vs. Exercise Therapy of non-retracted~     supraspinatus tendon tears, from baseline to 3 months, with continued evaluation of efficacy~     and durability up to 24 months.~      Secondary objectives include evaluation of US evidence of tendon repair; incidence of~     post-operative complications, adverse events, re-injections, and surgical intervention;~     change in pain score and use of pain medications.~   "
135881|NCT01788670|"~     Health benefits for humans derived from low dose intake of ethanol could partially be~     explained by its interaction with dopamine (DA) oxidative metabolism. Ethanol is expected to~     induce an increase in the formation of a DA minor metabolite: DOPET (hydroxytyrosol).~     Hydroxytyrosol is one of the most potent antioxidants present in Mediterranean Diet. The~     study is aimed at establishing the contribution of ethanol on hydroxytyrosol formation.~   "
135882|NCT01788657|"~     Internet-based cognitive behavior therapy (iCBT) has been shown effective for depression in~     several studies, however the investigators know very little about how the written treatment~     material should be designed to be effective and at the same time acceptable to the patients.~     The investigators are not aware of any research that has investigated if slow readers, or~     persons with difficulty concentrating, can use the standard material or if they would benefit~     more from using an adapted version.~      In this study the investigators will assess reading speed and the ability to concentrate in~     all patients and then randomise them to an internet-based treatment for depression using~     either a standard material or a condensed one. The condensed material consists of 30000 words~     and will be available as text files and on audio files. The standard material consists of~     60000 words and is only available as text files. Both groups will have the possibility of~     e-mail contact with a personal therapist during the treatment.~      Patients will be recruited within Örebro County by referrals and self-referrals. The goal is~     to recruit between 200 and 300 patients during 2 years. The treatment time will be 10 weeks~     and all patients will be assessed for depression at an interview with a psychologist. There~     will also be interviews after treatment and one year after treatment. The most important~     outcome will be depressive symptoms.~   "
135883|NCT01788644|"~     The purpose of this study is to examine risk factors associated with infant growth and the~     development of obesity in the first year of life. The investigators plan to establish a~     racially and ethnically diverse southern cohort of 800 mother/infant dyads, followed~     regularly from birth to 12 months of age. The cohort will be residents of Durham, North~     Carolina (NC) and the immediate surrounding area. The proposed longitudinal study will~     examine factors contributing to the development of obesity, including dietary behaviors,~     physical activity and inactivity, stress, and sleep duration and quality. Frequent in-home~     assessments throughout infancy and contact with other care providers will help pinpoint~     exactly when children begin to gain weight excessively and will identify risk factors related~     to energy intake, energy expenditure, stress, and sleep associated with obesity.~   "
135886|NCT01788605|"~     1. The purpose of this study is to determine the efficacy of ramosetron for the prevention~          of emesis and the control of nausea and vomiting despite of the prophylactic antiemetic~          treatment during hematopoietic stem cell transplantation~        2. The study hypothesis is that ramosetron is effective for the prevention of emesis and~          control of emesis and/or vomiting that develop after the prophylactic antiemetic therapy~          in the setting of hematopoietic stem cell transplantation~   "
135887|NCT01788592|"~     The objective of this study is to evaluate effectiveness and safety of drug-eluting stent~     implantation in the real world daily practice.~   "
145567|NCT01661790|"~     To determine the efficacy and Safety of intrapleural Bevacizumab and cisplatin as a treatment~     for malignant pleural effusions (MPE) in patients with non-small cell lung cancer (NSCLC).~   "
135888|NCT01788579|"~     This study aims to conduct a randomized controlled trial that will test the feasibility and~     preliminary effect of a multimedia version of a computerized multimedia intimate partner~     violence (IPV) prevention service tool designed to increase identification of IPV~     victimization and to improve linkages to IPV-related services among female offenders under~     court supervision or probation, compared to a non-media version of the same IPV screening,~     brief intervention and referral service delivered by a case manager. The study addresses the~     following: Primary study aims~        1. To design and beta-test a Computerized Multimedia IPV Screening, Brief Intervention and~          Referral Service tool for female offenders under court supervision or probation.~        2. To obtain preliminary estimates of the effects of the Computerized Multimedia versus the~          Case Manager IPV service conditions on identification of different types of IPV during~          the service session and on access to and utilization of IPV services over the~          three-month follow-up period.~        3. To examine and enhance the feasibility (recruitment, enrollment, fidelity of service~          delivery, client satisfaction, safety, and retention) for a future larger scale R01~          study.~           Secondary study aim~        4. To obtain estimates of the effects of the Computerized Multimedia versus the Case~          Manager IPV service conditions on recidivism, adherence to drug treatment (e.g.,~          attendance, completion) and abstinence of substance use over the follow-up period,~          controlling for baseline outcomes.~   "
135889|NCT01788566|"~     The purpose of this study is to see how participants with late stage lung cancer do on~     gemcitabine-cisplatin chemotherapy plus necitumumab. The study will also see how safe the~     drugs are in combination and to see how long the medicine stays in the body. The study will~     last approximately 2 years.~   "
135890|NCT01788553|"~     The aim of the study is to assess the remission rates in patients treated for generalized~     anxiety disorder in primary and specialized care. Factors that may influence remission such~     as disease history and severity of the anxiety disorder, the type of treatment, the presence~     of co-morbid depression or anxiety disorder as well as socio-demographic factors will also be~     evaluated. The study will also assess patient functioning and compare functioning in patients~     who do and do not achieve remission.~   "
135891|NCT01788540|"~     Intralipid infusion can improve the outcome in NK cells positive females with history of~     recurrent miscarriages undergoing IVF/ICSI cycles.~   "
135892|NCT01788527|"~     The primary objective of the study is to determine if RT CGM (Real Time-Continuous Glucose~     Monitoring) can improve glycemic control in women with T1D who are pregnant or planning~     pregnancy.~   "
135893|NCT01788514|"~     The investigators have developed an influenza-vaccination-education-study-program that will~     involve the use of an animated influenza vaccine-based computer program (videogame) that is~     designed from the investigator's own initiative. The investigators propose implementing an~     influenza vaccination educational program in the pediatric satellite office that serves a~     population that has historical low rates of influenza vaccination.~   "
135894|NCT01788501|"~     This study aims to compare efficacy and safety of tacrolimus/methotrexate with~     cyclosporine/methotrexate for graft versus host disease prophylaxis in paediatric allogeneic~     hematopoietic stem cell transplantation patients.~   "
135895|NCT01788488|"~     The goal of the study is to determine the impact of procalcitonin (PCT)-guided therapy on~     duration of antibiotic therapy in critical care unit (CCU) patients with suspected pneumonia~     at Mayo Clinic Health System Eau Claire.~   "
135896|NCT01788475|"~     Currently medications injected intravitreally in previously vitrectomized eyes have a very~     short half-life due to enhanced clearance of the drug. The use of the Ozurdex implant may~     allow sustained levels of steroid delivery to patients with diabetic macular edema that have~     undergone prior vitrectomy. The sustained steroid levels may lead to improved central retinal~     thickness measurements and improved visual acuity.~   "
135897|NCT01788462|"~     Sleep-disordered breathing is characterized primarily by partial or total upper airway~     obstruction during sleep. The most common form of sleep-disordered breathing is obstructive~     sleep apnea (OSA) due to recurrent collapse of the upper airway with the onset of sleep~     state. The major risk factors associated with the development of sleep apnea are obesity and~     male sex. The investigators have also found a high prevalence of OSA in HIV infected men and~     women, particularly among those with central lipohypertrophy, which is a common finding in~     HIV-infected persons receiving antiretroviral therapy. Currently, our overall hypothesis is~     that visceral adiposity, as seen in HIV-infected persons with central lipohypertrophy, alters~     both mechanical properties and compensatory neuromuscular responses leading to upper airway~     obstruction. Based on our most recent findings in the non-HIV population, the investigators~     demonstrate that obesity is associated with elevations in the upper airway load (passive~     Pcrit) that are counterbalanced by compensatory upper airway neural responses. Moreover, the~     investigators have found that female sex, peripheral adiposity, and younger age are~     associated with increased compensatory neuromuscular responses, while male sex, central~     adiposity, and older age are associated with blunted compensatory responses. The loss of the~     compensatory neuromuscular responses leads to obstructive sleep apnea. Among HIV-infected~     patients with central lipohypertrophy, tesamorelin (Egrifta), a growth hormone releasing~     hormone (GHRH) analogue, is approved for the reduction of visceral adipose tissue. The~     investigators hypothesize that tesamorelin therapy will reverse both the mechanical and~     neurocompensatory alterations associated with increased central obesity. In this project the~     investigators will determine whether tesamorelin affects sleep apnea severity and~     compensatory neuromuscular responses of the upper airway on sleep and breathing in men and~     women with HIV infection. The proposed studies are designed to elucidate the pathophysiologic~     basis for the development of obstructive sleep apnea in this population. The studies also~     provide insights into the neurohumoral regulation of upper airway function, and potentially~     new approaches to the treatment for sleep-disordered breathing.~   "
135898|NCT01788449|"~     Assess efficacy of piperacillin/tazobactam in reducing the cases of colonization and~     infection of bacteria.~   "
135899|NCT01788436|"~     The purpose of this study is to measure and contrast implicit and explicit learning~     performance in patients with schizophrenia relative to young and elderly healthy volunteers.~   "
135900|NCT01788423|"~     The purpose of this study is to compare the outcomes for two different hearing-aid delivery~     models. In one model, the audiologist selects and fits the hearing aid and, in the other~     model, the consumer does this directly.~   "
135901|NCT01788410|"~     The objective of this study is to provide pain relief to patients with facet joint disease or~     head and neck pain related to compression of a nerve root. The goal is to provide palliative~     care with superior efficacy and longer relief compared to current methods.~   "
135902|NCT01788397|"~     The main hypothesis:~      The participants receive treatment at Beitostølen within 8 weeks or within 16 weeks. The~     groups waiting for rehabilitation is compared with the group receiving rehabilitation~   "
135903|NCT01788384|"~     Acanya (Clindamycin Phosphate and Benzoyl Peroxide) Gel, 1.2%/2.5% gel marketed by Valeant~     Pharmaceuticals, North America, is a safe and effective topical therapy used for the~     treatment of acne vulgaris.~   "
135904|NCT01788371|"~     To explore the antiviral effect of nucleoside analogue in late pregnancy and the safety of~     the antiviral drug to fetus.To establish the best therapy strategy to pregnant women with~     high level of HBV DNA.~   "
135905|NCT01788358|"~     This study examines the long term safety and efficacy of the Fixed Dose combination~     BAY98-7106 (nifedipine plus candesartan primarily at the highest dose in development) in~     patients with moderate to severe hypertension.~      Patients meeting the entry criteria, will receive the Fixed Dose combination for 28 weeks,~     including 8 weeks with stepwise dose increase up to the high target dose. The first 200~     subjects completing 28 weeks will continue treatment for additional 24 weeks (52 weeks in~     total).~      Subjects who do not tolerate an increased dose will be treated at their highest tolerable~     dose.~   "
135906|NCT01788345|"~     The purpose of this study is to determine whether the new Boussignac-system of non-invasive~     ventilation is as good as the conventional non-invasive System in patients presenting with~     acute hypercapnic respiratory failure.~   "
135907|NCT01788332|"~     In 2010, more than 35,000 people died in the United Kingdom from lung cancer, the majority~     from non-small cell cancer (NSCLC). Chemotherapy is one of the main treatments for patients~     with NSCLC but those treated will still only live for an average of 9 or 10 months after~     diagnosis.~      The purpose of this clinical trial is to find out whether or not giving a drug called~     Olaparib following chemotherapy will benefit patients with NSCLC who have responded to~     initial chemotherapy treatment by prolonging the time before the tumour regrows. Olaparib is~     a new, oral drug developed by AstraZeneca which may help to slow down cancer growth. The~     rationale for this clinical trial is that chemotherapy damages tumour cell DNA and NSCLC~     tumours that respond to chemotherapy are less able to repair this damage. This can be~     exploited by using Olaparib as it blocks an enzyme called Poly (ADP-ribose) polymerase (PARP)~     which is essential for DNA repair. This will prevent DNA repair and cause cancer cell death~     by a mechanism known as synthetic lethality. Synthetic lethality arises when a combination of~     mutation in two or more genes leads to cell death.~      Up to 300 patients who are to receive standard chemotherapy treatment will be initially~     registered into the trial. Of these patients, 114 patients who have responded to chemotherapy~     will be randomly allocated to receive either Olaparib or an inactive dummy pill or placebo by~     mouth. The trial will assess whether Olaparib delays disease progression following standard~     chemotherapy treatment in patients. It will also show whether the side effects of adding~     Olaparib following standard treatment are acceptable.~   "
135908|NCT01788319|"~     This study will investigate if micropulse laser trabeculoplasty (532nm) is as effecttive as~     or better than the conventional laser trabeculoplasty (532nm), it might be a new treatment~     strategy for glaucoma patients. It is done with a laser device that can also be used for many~     other ophthalmic applications, thus reducing the economic burden of treatment.~   "
135909|NCT01788306|"~     This prospective, randomized emergency department trial will study the effectiveness of an~     intervention that combines opioid overdose prevention, education and intervention that~     includes take home naloxone with brief behavioral change counseling. The study will recruit~     both heroin users (n=500) and pharmaceutical opioid users at elevated risk for overdose~     (n=500). Outcomes of interest include subsequent opioid overdoses and overdose risk~     behaviors.~      Primary Aims~      The primary aims are to test whether those who receive the intervention compared to standard~     care have: 1) Lower rates of opioid non-fatal and fatal overdose; 2) Reduce drug use,~     inappropriate medication use, and other overdose risk behaviors.~      Secondary Aims~      The secondary aims are to test whether those who receive the intervention compared to~     standard care have: 3) More appropriate health care utilization (e.g. fewer emergency~     department visits and admissions to inpatient care); 4) Lower total health care costs; 5)~     Determine the prevalence of HIV risk behaviors among heroin and pharmaceutical opioid users~     at risk for overdose and whether the intervention impacts these behaviors.~   "
135910|NCT01788293|"~     Oximetry monitoring is common practice in patients undergoing anesthesia. PVI continuous~     evaluation may be a possibility of agility and ease of obtaining accurate information about~     the state of cardiovascular responsiveness to volume expansion.~      This prospective and randomized study will try to demonstrate that the assessment of PVI is a~     simple and cost-saving method as compared to cardiac output or oxygen delivery monitoring~     technologies. Such a simple approach has therefore the potential for widespread application~     as it is not routinely feasible for anesthetists to use cardiac output or oxygen delivery~     monitoring technologies in many institutions, as well as in many countries.~   "
135911|NCT01788280|"~     This exploratory study uses [18F] Fluciclatide and Positron emission tomography (PET) imaging~     in patients with glioblastoma multiforme (GBM) to be treated with Bevacizumab. The primary~     objective of this study is to determine the association of [18F] Fluciclatide uptake,~     fludeoxyglucose (FDG) uptake, and tumor blood flow/perfusion determined with H215O and~     Magnetic resonance imaging (MRI) and correlate these variables with time to progression (TTP)~     in participants with GBM treated with Bevacizumab.~   "
135912|NCT01788267|"~     Patients with cystic fibrosis are at risk of developing low bone mineral density (BMD)~     potentially leading to pathological fractures at adult age. Recent data from our center and~     others have suggested that low BMD could be observed very early in life. However,~     quantitative bone abnormalities found out by Dual X-ray absorptiometry (DXA) need to be~     confronted to qualitative evaluation of bone microarchitecture (surrogate of bone strength).~      High-Resolution peripheral quantitative computed tomography (HR-pQCT) is a recent technology~     with very high spatial resolution. Images obtained with this technic are considered as~     virtual bone biopsies. It enables an accurate bones' cortical and trabecular surfaces~     exploration in a three-dimensional manner, and therefore provides informations on bone~     microarchitecture as well as bone density.~      The aim of this study is to evaluate bone microarchitecture of paediatric patients matched to~     sex-age-pubertal status-healthy volunteers. In the meantime, biological markers will be~     collected and DXA (Dual-energy x-ray absorptiometry) will be performed in order to explore~     potential correlations HR-pQCT parameters.~   "
135925|NCT01788098|"~     The study is aimed at revealing genetic background in rheumatoid arthritis (RA). For that~     purpose samples of DNA will be collected from 500 RA patients and similar number of controls~     from whole Slovakia. Variations in several genes associated with RA will be evaluated. The~     second aim is to assess functional changes in immune cells from selected patients and their~     evaluation together with genetic background. The project has observational character without~     any intention to change the treatment of RA patients.~   "
135913|NCT01788254|"~     Aim of this study is to comprehensively assess in healthy volunteers the metabolic processes~     and factors that define drug response. Sources of variability are to be investigated and~     factors that can alter the hepatic metabolism and the pharmacokinetics of drugs shall be~     quantified.~      Determination of variability is important when the pharmacokinetics of new drugs is being~     investigated and when the concept of individualized medicine is to be further developed. It~     is important to identify and differentiate between pharmaceutical, physiological (e.g. liver~     blood flow, renal function), environmental (e.g. foods and lifestyle), and genetic sources of~     inter-individual variability. For instance, inaccurate or false conclusions may be drawn from~     a single pharmacokinetic study, if the investigated medicine is metabolized by an enzyme with~     large inter-individual variability. Knowing the causes of variability and of the quantitative~     contribution of various processes might help to improve the oral formulations of drugs, might~     help selecting the right preclinical tests and selection criteria during clinical~     development, provide the basis to understand the influence of disease and to optimize~     established drug treatments in order to make future drug treatment safer and more efficient.~      This study is designed as an add-on to the study TWINS: Open Label Repeated Dose Study for~     the Evaluation of Heritability of and Genetic Influences on Drug Pharmacokinetics (Eudra-CT:~     2008-006223-31). Twins are not a random sample of the population, and they differ in their~     developmental environment. In this sense they are not representative for the population Thus,~     the results of TWINS cannot be automatically generalized but instead require validation in a~     representative population sample. While both studies assess pharmacologic factors important~     for drug response, TWINS contributes in particular data on the heritability of these~     processes.~   "
135914|NCT01788241|"~     Psychosocial factors have been found to be associated with an increased risk for coronary~     artery disease incidence, progression and worse clinical outcomes.~      Patients with non-significant coronary artery disease (confirmed vascular irregularities, but~     <60% coronary occlusion) often present with complaints such as chest pain, which warrant~     screening by coronary angiography (CAG) or computed tomography (CT scan). The prognosis of~     this group of patients with mild stenosis remains to be investigated in more detail, and we~     propose that psychosocial factors play a role in the clinical prognosis and patient reported~     outcomes in this group.~      A special focus lies within examining personality characteristics, of which Type D~     personality is a primary predictor variable for prognosis. Type D personality is~     characterised by high negative affect and high social inhibition. In addition to psychosocial~     factors (personality, mood state, social support, SES), biomarkers(inflammation, clotting,~     DNA) as well as standard clinical risk factors (metabolic syndrome, activity level, smoking,~     medication use, disease severity) will be investigated.~      The goal of the proposed study is to investigate a preexisting psycho-biochemical risk~     profile for major adverse cardiovascular events (MACE) and patient perceived symptoms in a~     group with angiographically or CT-scan confirmed, non-significant coronary artery disease.~   "
135915|NCT01788228|"~     The purpose of this study is to evaluate the safety and tolerability of GSK Biologicals'~     vaccine GSK1557484A against pandemic avian (H5N1) influenza in adults at occupational risk of~     exposure to the virus.~   "
135916|NCT01788215|"~     The purpose of this study is to study the effect of a commonly used antibiotic, doxycycline,~     on the production of ovarian hormones and menstrual cycles in women with Polycystic Ovarian~     Syndrome (PCOS).~   "
135917|NCT01788202|"~     When it is safe to administer general anesthesia to the patient with cocaine positive urine~     drug screen has never been clearly determined. The study doctors would like to determine the~     effect of cocaine on blood pressure, heart rate and rhythm during surgery. After surgery, the~     subjects will be observed in regards to mental status and any changes in heart rate and~     rhythm.~   "
135918|NCT01788189|"~     Multicenter prospective open-label non-randomised phase I/II study in patients with relapsed~     or refractory CD20-positive aggressive lymphomas~      Phase I:~      Dose escalation of methotrexate and cytarabine (days 1, 8 and 15 of each 28-day cycle) in a 3~     + 3 design with fixed doses of lenalidomide (days 1 - 21) and rituximab (day 1), maximum 6~     cycles~      Phase II:~      Treatment of 20 patients at maximum tolerated doses of phase I~   "
135919|NCT01788176|"~     To evaluate the efficacy and the safety of using a single, intravenous 5mg dose of zoledronic~     acid in managing pain in Complex Regional Pain Syndrome patients.~   "
135920|NCT01788163|"~     Interventional diagnostic, international, multicenter and non-comparative study of EGFR~     mutation status in aNSCLC patients (locally advanced and/or metastatic disease) with~     adenocarcinoma and non-adenocarcinoma histologies. It will be conducted in Asia Pacific and~     Russia and will assess the current status of EGFR mutation testing, and the concordance of~     EGFR mutation status derived from tumour samples and blood based circulating free DNA.~   "
135921|NCT01788150|"~     A prospective, randomized, active-control, multi-center clinical trial comparing the safety~     and efficacy of the Svelte Drug-Eluting Coronary Stent Integrated Delivery System (IDS) to~     that of the commercially available Resolute IntegrityTM Drug-Eluting Stent.~      The study objective is to assess the safety and efficacy of the Svelte Drug-Eluting Coronary~     Stent Integrated Delivery System (IDS) compared to the Resolute IntegrityTM Drug-Eluting~     Stent in patients with single, never previously treated coronary artery lesions~   "
135922|NCT01788137|"~     This is a prospective , open, multicenter, randomized phase III study. The investigators~     planed to include 380 untreated high risk T cell lymphoma adults,to random to CHOP and c-ATT~     regimen groups after signature the informed consents. The patients will receive safety~     assessment every cycles, and efficacy evaluation every 3 cycles. Every-two-months follow up~     will be received after finishing the treatment.~   "
135923|NCT01788124|"~     The purpose of this study is to evaluate the comfort of two type of speculums used during~     routine gynecologic exam. Your treatment and medical care will not change because you are~     participating in this study. Your doctor will continue to make all decisions regarding your~     proper treatment and care.~   "
135924|NCT01788111|"~     The purpose of this project is to investigate the occurrence of neck and back pain in a~     population of commercial helicopter pilots, and investigate factors related to the profession~     that can cause these problems. The project has a biological approach assessing the supporting~     and stabilizing muscles (multifidus) in pilots with chronic back and neck ailments. Pilots~     with low back problems are invited to a controlled intervention trial to investigate whether~     one can achieve improved spinal health with a rigid training régime. Primary trial outcome is~     improved neck and back multifidus muscles pathology and function as assessed by the extent of~     fat infiltration -as visualized on MRI - and the volume and ability of the lumbar multifidus~     muscles to contract as shown with ultrasound. The perceived effect on spinal health with sick~     leave frequency is also evaluated.~   "
137454|NCT01768078|"~     One useful effect of early intravitreal corticotherapy is to diminish inflammatory~     complications after endophthalmitis, which may cause, at least in part, serious complications~     (retinal detachment, macular edema) which are, more than the infection, causes of the~     complications seen after acute endophthalmitis.~   "
135926|NCT01788085|"~     Study Hypothesis: This study is designed as an integral part of the development of new or~     improved features or components of the Bravo® pH Monitoring System and may serve verification~     and validation purposes.~      The study population will include symptomatic patients with known or suspected~     gastroesophageal reflux disease~      Symptomatic patients will undergo invasive procedure, including Bravo capsule delivery,~     positioning and attachment. Confirmation of capsule attachment may be done endoscopically.~      These procedures will serve to evaluate overall system performance in actual clinical setup,~     for instance: ergonomics and performance of delivery device, capsule transmission etc.~      Physician may be asked to provide feedback on the procedure and/or document their activities~     during the procedure.~   "
135927|NCT01788072|"~     There is substantial evidence from animal model and healthy control data, that oxytocin is~     involved in the modulation of social cognition. In addition, recent genetics and plasma level~     studies suggest a possible role for oxytocin in the pathophysiology of Autism Spectrum~     Disorders (ASD). As a large number of children with ASD are transitioning into adulthood and~     will likely require treatment, the lack of data to make meaningful treatment recommendations~     to facilitate adult living is an urgent issue. This study will examine the effect of~     intranasal oxytocin (IN-OXT) on social function in adults with ASD. It is hypothesized that~     IN-OXT will be superior to placebo in improving social function by the end of study~     treatment.~   "
135928|NCT01788059|"~     Because the rate of non union of long bone in lower extremities specially in tibia in this~     two last decade due to malnutrition and smoking and other risk factors was increased, so many~     patient in our country suffer from non union on the other hand it seems that the use of the~     mesenchymal stem cells can irritate the union rate. Therefore the investigators decide to~     inject the mesenchymal stem cell derived from iliac bone marrow after centrifuge with ficoll~     procedure to non union site in patient that are resistant to other treatment. Then the~     investigators will follow the patient with monthly radiography and evaluate the callus volume~     and clinical union and any side effect of this treatment.clinical union consider to relief~     pain in non union site and be stable in examination.~   "
135929|NCT01788046|"~     This study is designed to assess the efficacy and safety of etelcalcetide (AMG 416) compared~     with placebo in the treatment of SHPT in CKD patients receiving hemodialysis.~   "
135930|NCT01788033|"~     To assess the effects of treatment with XOMA 052 on beta-cell function and insulin production~     in subjects with well-controlled Type 1 diabetes. The safety, tolerability, and~     pharmacokinetics (PK) of XOMA 052 will also be assessed.~   "
135931|NCT01788020|"~     In Waldenström macroglobulinemia (WM) conventional chemotherapy induces only low CR rates and~     responses of short duration compared to other indolent lymphomas. Thus innovative approaches~     are needed which combine excellent activity and tolerability in patients with WM, who are~     mostly of advanced age. The immunochemotherapy DRC (dexamethasone, rituximab,~     cyclophosphamide) was shown to be highly effective in patients with WM without inducing major~     hematological toxicities. On the other hand the proteasome inhibitor Bortezomib showed~     substantial activity as a single agent in WM with only very few side effects when given in a~     weekly schedule. Based on these observations it is the aim of this study to test whether the~     efficacy of the well tolerated DRC regime can further improved by adding Bortezomib.~   "
135932|NCT01788007|"~     The objective of this study is to compare the relative efficacy and safety of the test~     formulation Imiquimod 3.75% Topical Cream to the marketed formulation Zyclara® (imiquimod)~     3.75% Topical Cream in the treatment of actinic keratosis. Both the test and reference~     formulations will also be compared to a placebo cream to test for superiority.~   "
135933|NCT01787994|"~     This is an open label, dual cohort study evaluating safety, tolerability and immunogenicity~     of redirected CD4+ T cells in HIV subjects.~   "
135934|NCT01787968|"~     T. cruzi has been divided into two main lineages: T. cruzi I (TcI) and T. cruzi II (TcII,~     including all non-TcI). TcI is predominant in Mexico and Central America, while TcII~     (non-TcI) is predominant in most of South America, including Argentina. In recent studies~     from Argentina, the risk of congenital transmission has been estimated to vary between 2.6~     percent and 7.9 percent. By contrast, we know very little about the congenital transmission~     of TcI. It has been suggested that congenital transmission of T. cruzi is strain related, and~     there is an urgent need to know if TcI transmits differently than TcII (non-TcI). Our primary~     hypothesis is that congenital transmission rates are different for TcI versus TcII. Our~     secondary hypothesis is that the characteristics of T. cruzi infected mothers (e.g., age,~     parity, transmission in previous pregnancies) and their exposure to vectors are different in~     regions where TcI is predominant versus regions where TcII (non-TcI) is predominant. To test~     these hypotheses, we propose to conduct a prospective study to enroll at delivery 13,000~     women in Mexico, 7,500 women in Honduras, and 10,000 women in Argentina. We will measure~     transmitted maternal T. cruzi antibodies in cord blood, and, if the results are positive, we~     will identify infants who are congenitally infected by performing parasitological~     examinations on cord blood and at 4-8 weeks, and serological follow-up at 10 months. We will~     also perform standard PCR, real-time quantitative PCR, and T. cruzi genotyping on maternal~     blood, standard PCR and T. cruzi genotyping on the cord blood of congenitally infected~     newborns, and serological examinations on siblings. We will estimate the exposure to vectors~     in the household. In addition, we will measure prenatal outcomes among infected and~     uninfected infants with seropositive mothers, and the birth weight of their siblings. The~     specific aims of this study are: 1) To determine the rate of congenital transmission of TcI~     compared to TcII (non-TcI); 2) To compare the T. cruzi infected mothers' characteristics and~     exposure to vectors in regions where TcI is predominant and regions where TcII (non-TcI) is~     predominant; and 3) To describe the birth outcomes of infected and uninfected infants born to~     TcI and TcII seropositive women.~   "
135935|NCT01787955|"~     Pylorus preserving pancreaticoduodenectomy (PPPD) has been considered as only curative~     treatment modality for periampullary tumor. High mortality rates after PPPD have been reduced~     down to 1%. However, postoperative morbidities are still reported around 10 to 20 % even in~     high volume centers.The delayed gastric emptying syndrome(DGE) is one of major complications~     after PPPD. Many randomized control studies reported that pylorus preserving method was not~     related to the occurence of DGE. Thus,we assumed that large amount of biliary and pancreatic~     juice might affect DGE.~      With the aim to prove that the use of Braun anastomosis after PPPD can prevent DGE, the~     investigators started the recruitment of patients with a periampullary tumors to this~     clinical trial from february 2013 with the study hypothesis that patients with Braun~     anastomosis had less DGE than those who only got conventional PPPD.~      The investigators have calculated the number of patients necessaries to have statistical~     significant differences in 60 patients with a rate DGE expected to be higher than 30%.~      The study include all the patients that usually arrive to our surgery department and who are~     indicated to PPPD for the curative treatment of periampullary tumor.~      The study is randomized, double blind where the investigators and the patients do not know if~     the patients are in the Braun anastomosis group or not, and prospectively analyzed. All the~     clinical and laboratory or radiographic finds relative to the occurrence of DGE are recorded.~   "
135936|NCT01787942|"~     Deficiency in tear film lipid layer thickness (LLT) has been implicated in the development of~     dry eye symptoms, and is influenced to a significant degree by the anatomy and function of~     the eyelids. Patients who are considering blepharoplasty, even if it is for cosmetic reasons,~     may subtle differences in eyelid anatomy that pre-dispose them to having an abnormal tear~     lipid layer. Moreover, the changes in anatomy and contour of the eyelids following~     blepharoplasty introduce a whole new group of factors, such as an altered palpebral aperture~     and altered canthal fixation that can further change the eyelid's ability to maintain a~     healthy tear lipid layer, for better or for worse. Such changes in tear lipid layer can be~     detected with the aid of a newly acquired tear interferometer (LipiView, Tearscience Inc.),~     but has never been done in the context of blepharoplasty management. Due to the strong~     association between LLT and risk of dry eyes, we hope to investigate if there are significant~     differences in LLT and other objective dry eye parameters in two situations: 1) patients~     considering blepharoplasty as compared to other patients not considering such procedures 2)~     patients before and after undergoing blepharoplasty. The results of these investigations can~     go towards establishing LLT as an important objective parameter to account for before and~     after blepharoplasty.~   "
135937|NCT01787929|"~     The purpose of this study was to identify the clinical relevance of cementless~     hemiarthroplasties, compare Harris functional score.The hypothesis is the non-inferiority of~     cementless hemiarthroplasties compare cemented hemiarthroplasties in order to justify the~     relevance of cementless hemiarthroplasties in displaced femoral neck fractures.~      150 patients will be included, 75 with cemented hemiarthroplasty and 75 with uncemented~     hemiarthroplasty. They will be followed during one year after the surgery, with a~     functionality assessment at 3 month and 12 month.~   "
135938|NCT01787916|"~     To our knowledge, no trial has specifically studied the effect of liraglutide combined with a~     basal/bolus insulin regimen in type 1 diabetes in a cross-over, double-blind, unicentric~     model. Moreover, the potential impact of a glucagon-like peptide-1 agonist on measures of~     abdominal fat (assessed by CT scan), insulin sensitivity (assessed by the gold standard~     euglycemic-hyperinsulinemic clamp) and satiety sensations have not been evaluated in this~     population.~      Hypothesis Overweight participants with type 1 diabetes on liraglutide/insulin treatment will~     present improved glucose control with decreased HbA1c, decreased fasting and mean weekly~     glucose concentrations and glycemic excursions as well as increased insulin sensitivity~     compared to participants on placebo/insulin treatment. Participants with liraglutide/insulin~     treatment will also present improved endothelial function, lower body weight, central adipose~     tissue assessed by CT scan and higher satiety sensations assessed by visual analogue scales.~   "
135939|NCT01787903|"~     The purpose of this study is to determine what the effects are of real-time continuous~     glucose monitoring on glycemia and quality of life in patients with type 1 diabetes mellitus~     and impaired hypoglycemia awareness.~   "
135940|NCT01787877|"~     Stroke represents the third commonest cause of death after heart disease and all types of~     cancer combined, and is the leading cause of long-term permanent disability among adults.~     Recombinant tissue plasminogen activator (tPA) is currently the only safe medical treatment~     for acute ischemic stroke but only a small fraction of patients are eligible for a~     thrombolysis treatment. Current guidelines on thrombolysis post stroke with tPA exclude its~     uses beyond 3 hours after stroke onset and when time of onset is unknown thus excluding many~     patients from potentially beneficial treatment.~      For an appropriate triage and management of patients, it is essential to improve imaging~     techniques beyond a simple CT scan. Perfusion computed tomography (PCT), currently considered~     as an investigational technique, permits a quantitative determination of the cerebral~     perfusion within the brain. It helps distinguish salvageable ischemic penumbra from~     irreversibly infarcted core in acute stroke patients. This technique has therefore the~     potential to select patients who are most likely to benefit from thrombolysis with tPA, can~     be used to predict the benefit after thrombolysis and determine the suitability for other~     therapeutic interventions. In patients with a primary diagnosis of TIA, PCT would help to~     identify possible persistent cerebral ischemia but also provide important information for~     rapid instigation of prophylactic strategies.~      The diagnosis and management of patients with ischemic stroke and TIA is challenging and is~     primarily based on clinical assessment in conjunction with neuroimaging. Development of~     specific molecular biomarkers as additional tools to support a clinical diagnosis, exclude~     common stroke mimics such as migraine or epileptic seizures, identify patients at risk of~     disease, and help guide patient treatment by predicting complications following t-PA~     treatment would be of great value.~   "
135941|NCT01787864|"~     We propose a tissue sample collection study for patients at UNC who have undergone or will~     undergo radiofrequency ablation therapy for Barrett's Esophagus (BE) or intramucosal~     adenocarcinoma as part of routine medical care.~      Purpose:~      To determine the prevalence of metaplasia and dysplasia in the gastric cardia before and~     after ablative therapy.~      To determine the incidence of cardiac metaplasia and dysplasia as a function of ablative~     therapy.~      To determine the correlation between dysplasia in the tubular esophagus, and dysplasia in the~     cardia.~      To assess the ability of immunohistochemical (IHC) staining of cardia tissues to predict~     incident dysplasia in the cardia. Several well-characterized biomarkers, including p16, p53,~     Ki67, cyclin D1, and cyclin A, will be assessed.~   "
135942|NCT01787851|"~     Patients with dilated cardiomyopathy who present for indwelling right heart catheterization~     will be enrolled and randomized to either control or triheptanoin oil for five days.~     Hemodynamics will be assess serially.~   "
135943|NCT01787838|"~     The purpose of this quality improvement project is to improve the immunization rates of an~     at-risk adult population seen in an ambulatory healthcare environment, through the use of~     targeted health education messages regarding pneumococcal immunization. Patients seen in an~     out-patient pre-surgical testing center will receive 1) a one-page written information sheet~     that outlines the benefits of pneumococcal immunization and 2) verbal reinforcement of this~     message, provided by the clinical staff, during the patient's interview.~      At-risk adult patients (as defined by Centers for Disease Control) seen in an ambulatory~     healthcare environment (a pre-surgical testing center) will receive a one page, gain-framed~     message that emphasizes the benefits of pneumococcal vaccinations. This educational material~     will be reviewed and reinforced by clinical staff during the assessment phase of the clinical~     visit. Among this group, there will be increased vaccination rate compared with at-risk adult~     patients who did not receive this communication (prospective vs retrospective data).~   "
135944|NCT01787825|"~     The purpose of this study is to compare the clinical findings involving the small bowel~     obtained with the Capso Vision Video Capsule Device to those results obtained with the~     PillCam SB2.~   "
137455|NCT01768065|"~     This study will evaluate effectiveness and adherence of the nasal expiratory positive airway~     pressure (NEPAP) device as an an alternate therapy for children with Obstructive Sleep Apnea~     Syndrome (OSAS). NEPAP is currently approved for use only in adults.~   "
135945|NCT01787812|"~     The California Joint Replacement Registry (CJRR) was created to meet the need for~     comprehensive, scientific assessment of devices, treatment protocols, surgical approaches,~     and patient factors influencing the results of hip and knee replacement surgeries.~     Importantly, it is a Level 3 registry, meaning it collects and incorporates clinical~     information and direct feedback from patients about the outcomes of hip and knee replacement~     surgeries. It is one of only a small number of registries in the United States to do so.~      The CJRR's goals are to:~        -  Collect and report scientifically valid data on the results of hip and knee replacements~          performed in California, including device safety and effectiveness, post-operative~          complication and revision rates, and patient-reported outcomes; and~        -  Promote the use of performance information regarding hip and knee replacements to guide~          physician and patient decisions and to support programs for provider recognition and~          reward.~      Specifically the CJRR is designed to:~        -  Minimize burden on participants by using electronic data sources, rather than manual~          data entry or chart review.~        -  Compile reports assessing the outcomes associated with different devices and surgical~          techniques.~        -  Create benchmarking reports for physicians and hospitals that detail performance data~          and compare it to statewide averages.~        -  Transmit safety alerts on devices with short-term results that provoke concern.~        -  Shape a measurement and reporting system for total hip and total knee replacement~          surgeries.~      The CJRR was developed by the California HealthCare Foundation (CHCF), the Pacific Business~     Group on Health (PBGH), and the California Orthopaedic Association (COA). PBGH manages the~     day-to-day operations of the CJRR.~      CJRR's data elements are aligned with other major orthopedic registries. The CJRR is a member~     of the International Consortium of Orthopedic Registries (ICOR) and the International Society~     of Arthroscopic Registries (ISAR).~   "
135946|NCT01787799|"~     The purpose of this study is to evaluate 9 month angiographic and intravascular ultrasound~     (IVUS) data for the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System~     (SYNERGY Stent System) in the treatment of subjects with atherosclerotic lesion(s) ≤34 mm in~     length (by visual estimate) in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by~     visual estimate).~   "
135947|NCT01787786|"~     The purpose of this study is to develop a predictive model that will allow optimized dosing~     of infliximab for individual patients~   "
135948|NCT01787773|"~     This is a prospective, multicenter single arm, nonrandomized study that will include 150~     patients at a maximum of 20 investigational sites. It is estimated that it may take 13 months~     to complete enrollment. Follow-up will continue through 24 months post-implant or one month~     post-retrieval, whichever occurs first. It is required that filters be retrieved from at~     least 50 patients and the filter is permanent in at least 50 patients.~   "
135949|NCT01787760|"~     This study is to investigate whether novel soft contact lens optical designs can slow myopia~     progression.~   "
135950|NCT01787747|"~     To assess the single- and multiple-dose pharmacokinetic (PK), safety and tolerability of~     AVP-786 in healthy volunteers.~   "
135951|NCT01787721|"~     The purpose of this study is to determine if manipulation of the ankle improves some~     measurable characteristics of how a person walks. The investigators hypothesize that the~     ankle will be able to bend better after manipulation and thus improve walking speed and~     reduce differences between the two limbs.~   "
135952|NCT01787708|"~     Vitiligo is a chronic acquired disease characterized by well defined white macules and~     patches affecting the skin. There are many treatment modalities available for vitiligo,~     however, none of them cure the disease. Visible red light has been shown to stimulates~     melanocyte migration and proliferation resulting in repigmentation of vitiligo patches.~     However, there are only a few studies published on the efficacy of red light in vitiligo.~     This is a prospective single-blind randomized clinical trial to assess efficacy of red light~     in the treatment of vitiligo.~   "
135953|NCT01787695|"~     Vitiligo is a chronic acquired disease characterized by well defined white macules and~     patches affecting the skin. There are many treatment modalities available for vitiligo,~     however, none of them cure the disease. Ultraviolet A1 (UVA1) phototherapy has been shown to~     be useful for a variety of skin diseases. However, there are only a few studies published on~     the efficacy of UVA1 in vitiligo. This is a prospective single-blind randomized clinical~     trial to assess efficacy and safety of UVA1 in the treatment of vitiligo.~   "
135954|NCT01787682|"~     Weight loss commonly occurs in patients with chronic heart failure (CHF) and chronic~     obstructive pulmonary disorder (COPD), negatively influencing their quality of life,~     treatment response and survival. Loss of muscle protein is generally a central component of~     weight loss in CHF and COPD patients but patients also have reductions in fat mass and bone~     density, independent of the severity of the disease state. The purpose of this~     cross-sectional study is to provide detailed insight in disease related gut function by~     obtaining information on gut permeability, digestion and absorption of glucose, fat and~     protein in CHF and COPD patients compared to matched healthy controls. This will provide~     required information that is necessary to implement new strategies to develop optimal~     nutritional regimen in CHF and COPD. The hypothesis is that CHF and COPD are related to~     decreased gut function and absorption, leading to decreased anabolic response. Second, this~     decreased nutritional status is linked to reduced muscle functioning and possibly decreased~     cognition. In addition, we will examine the effect of aging on by comparing gut function~     digestion and absorption of the CHF and COPD aged matched healthy controls to a group of~     young healthy subjects.~   "
135955|NCT01787669|"~     The specific aim of the study is to test the following hypothesis:~      That switching between treatments from bevacizumab to Ozurdex or vice versa in eyes with~     diabetic macular oedema with no or incomplete response from one therapy is beneficial.~   "
135956|NCT01787656|"~     Ovarian cancer is deadly and generally diagnosed at late stage when the chances of survival~     are low. There is a current belief that this cancer starts in the fallopian tubes and~     progresses towards the ovaries, spreading to the cells on the surface. Within the fallopian~     tubes and the uterus, there is a constant flow of mucus which has only one exit through the~     cervix and out the vagina. Proteins that are generated within the entire female reproductive~     system are trapped into this viscous fluid and eventually released as waste. When a routine~     PAP test is performed, a sample of this mucus is collected along with any cells, and~     preserved in the PAP fluid. The fluid is currently discarded but contains a protein profile~     showing of the status of the cells in the female reproductive system. We have examined this~     fluid and found that it contains unique peptides/proteins that provide a diagnosis of ovarian~     cancer when compared against healthy controls. These markers will be initially refined using~     the comparison of ovarian cancer patients against those with benign adnexal masses that~     entered the clinic during the same time period.~      In this Phase II biomarker validation study we will further refine and validate these~     biomarkers using a new collection of samples from at least 200 ovarian cancer cases with~     epithelial ovarian cancer (endometroid and papillary serous histology, most common) and~     comparing these against 600 patients with a diagnosis of a benign adnexal mass that enter the~     clinics during the same time period. Patient samples will be collected on their first visit~     to the gynecologic oncologist at a number of collaborating clinics. Final processing of all~     of the samples will be performed within the proteomics research facilities of the Mitchell~     Cancer Institute using Selected Reaction Monitoring (SRM, with mass spectrometry) based on~     the refined set of makers statistically selected within the first aim. Biomarkers validated~     within this study will be compared with the well accepted CA-125 data for the patients. The~     research involves a three year validation and may allow detection of this cancer at a very~     early stage when the survival is as high as 90%. One aim examines a self-taken test that~     could allow its use in medically underrepresented and rural areas.~   "
135958|NCT01787630|"~     The dominating problem after local radiotherapy of prostate cancer is rectal toxicity. If the~     rectum could be completely moved out of the treated volume, a substantial decrease of rectal~     toxicity seems reasonable. In this study we will develop and evaluate a new transrectal~     injection technique where hyaluronic acid (HA) is injected in the space between the prostate~     and the rectum prior to external beam radiotherapy to increase the physical distance between~     prostate and rectum.~   "
135959|NCT01787617|"~     The purpose of this study is to investigate the effect of an exercise training intervention~     on the ability of African American males to use insulin properly. Insulin is a hormone that~     helps the body use glucose.~   "
135960|NCT01787604|"~     Authors hypothesize that aortic root reimplantation procedure is superior over standard~     aortic valve reimplantation procedure in the incidence of aortic valve replacement.~   "
135961|NCT01787591|"~     This study is conducted to investigate if vitamin E status in healthy individuals and~     individuals with metabolic syndrome can be improved by dairy fat. The investigators~     hypothesize that full-fat dairy will substantially increase the bioavailability of~     alpha-tocopherol, a form of vitamin E. The results of this study will contribute to the~     application of dairy fat as a simple and effective strategy for improving vitamin E status,~     which is partly due to poor vitamin E intake. By completing this study, the investigators~     anticipate developing new dietary recommendations to achieve adequate vitamin E status~     through the regular consumption of dairy fat paired with foods containing vitamin E.~   "
135962|NCT01787578|"~     The purpose of this study is to assess the safety, tolerance, pharmacokinetics, and~     pharmacodynamics of sobetirome, a selective thyroid hormone analog, in adult male X-ALD~     patients.~   "
135963|NCT01787565|"~     The aim of this investigation is to determine whether the use of painPREMIER will~     significantly improve function in patients with low back pain in an occupational health~     clinical setting. painPREMIER is a tool that assists clinicians in the accurate diagnosis of~     back pain and associated problems in order to treat them most effectively.~   "
135964|NCT01787552|"~     The purpose of this phase Ib/II clinical trial is to: a) evaluate the safety of the~     co-administration of LDE225 and INC424 in myelofibrosis patients and establish a maximum~     tolerated dose and/or Recommended Phase II dose of the combination and b) to assess the~     efficacy of the co-administration of LDE225 and INC424 on spleen volume reduction.~   "
135965|NCT01787539|"~     Taking into account the substantial doubts concerning the potential benefit of postoperative~     part in the perioperative chemotherapy regimen we designed a study assessing value of this~     approach in gastric cancer. To improve compliance with a protocol regimen of this aggressive~     combined therapy we replaced tested in the MAGIC trial ECF regimen with more effective and~     better tolerable EOX chemotherapy regimen. The value of postoperative three-cycle EOX regimen~     will be tested in patients with locoregionally advanced gastric cancer with positive~     pathological response to preoperative three-cycle EOX chemotherapy regimen. The patients will~     be randomized to the postoperative chemotherapy or to the follow-up arm.~   "
135966|NCT01787526|"~     2-3% of the population participates in blood donation programmes. Traditionally, safety~     issues in transfusion medicine have been concentrating on product and recipient safety.~     Extensive efforts including strict donor inclusion criteria and testing for important~     transmissible infections have substantially improved product quality. One of the most common~     risks of blood donation is iatrogenic iron deficiency. It may affect up to 30% of regular~     blood donors because each whole blood donation causes a loss of 200 to 250 mg of iron.~     Although this has been known for at least 50 years, iron deficiency is not routinely assessed~     or treated in this population. Contributing factors include donation frequency, lower weight~     and female gender. Women have lower iron reserves and in premenopausal women, the daily~     required amount of iron is higher than in men. Besides anemia, iron deficiency may lead to~     fatigue and impaired cognitive and physical performance. Oral iron substitution is often~     associated with significant gastrointestinal side effects leading to poor compliance. Today,~     intravenous (iv.) iron preparations are well tolerated and allow the application of a large~     dose of 1000mg in one visit. Our hypothesis is that in blood donors with iron deficiency~     intravenous iron is feasible and preferable to oral iron because of its high efficacy and~     optimal compliance with a similar safety profile that has been extensively studied in other~     populations than blood donors.~   "
135967|NCT01787513|"~     A randomised controlled trial comparing Internet based cognitive behavioural therapy for~     major depressive disorder plus a cognitive bias modification intervention (OxIGen) version A~     vs. Internet based cognitive behavioural therapy for major depressive disorder plus a~     cognitive bias modification intervention (OxIGen) version B on symptoms of depression and~     negative interpretation bias.~   "
135968|NCT01787500|"~     The goal of this clinical research study is to find the highest tolerable dose of vemurafenib~     that can be given in combination with cetuximab and irinotecan to patients with advanced~     cancer. The safety of this drug combination will also be studied.~      Vemurafenib is designed to block BRAFV600 inside the cancer cells, which is involved in~     cancer cell growth.~      Cetuximab is designed to block proteins inside the cancer cell, which may prevent or slow the~     growth of cancer cells and leads to cell death.~      Irinotecan is designed to stop cancer cells from making new DNA (the genetic material of~     cells). If the cancer cells cannot make DNA, they cannot divide into new cells and may die.~      This is an investigational study. Vemurafenib is FDA approved and commercially available for~     the treatment of certain types of melanoma in patients with BRAF mutation.~      Cetuximab is FDA approved and commercially available for the treatment of KRAS wild type,~     EGFR expressing metastatic colorectal cancer and squamous cell carcinoma of the head and~     neck.~      Irinotecan is FDA approved and commercially available for the treatment of metastatic~     colorectal cancer.~      The use of these drugs together in advanced cancer is investigational.~      Up to 33 patients will be enrolled in this study. All will be enrolled at MD Anderson.~   "
136022|NCT01786785|"~     Acute ischemic stroke affects roughly 1 in 50,000 children every year and is one of the top~     ten causes of death in children. Currently, caregivers lay the affected child flat in hopes~     of increasing blood flow to the brain and reducing the volume of the brain which is damaged.~     However, there are currently no techniques to measure brain blood flow at the child's bedside~     and indicate if this treatment is effective. We will probe brain blood volume, oxygen~     saturation, and flow with red light to determine the efficacy of this intervention.~   "
135969|NCT01787487|"~     You are being asked to take part in this study because you have myelofibrosis or~     myelodysplastic/myeloproliferative neoplasm.~      The goal of this clinical research study is to learn if the combination of ruxolitinib and~     azacytidine can help to control myelofibrosis and myelodysplastic syndrome/myeloproliferative~     neoplasm.~      Ruxolitinib is designed to block a pathway that has been found to be overactive in human~     cancers and myelofibrosis.~      Azacytidine is designed to block certain proteins in cancer cells that stop the function of~     the tumor-fighting proteins. By blocking the bad proteins, the tumor-fighting genes may be~     able to work better.~      This is an investigational study. Ruxolitinib is FDA approved and commercially available to~     treat myelofibrosis. Azacytidine is FDA approved and commercially available for~     myelodysplastic syndrome. The combination of ruxolitinib and azacytidine to treat~     myelofibrosis and myelodysplastic syndrome/myeloproliferative neoplasm is investigational.~      Up to 125 participants will be enrolled in this study. All will take part at MD Anderson.~   "
135970|NCT01787474|"~     Objectives:~      Primary Objective Determine the safety, feasibility, and maximum tolerated dose of~     mbIL21-expanded haploidentical NK cells after induction chemotherapy with fludarabine,~     cytarabine, and G-CSF (FLAG).~   "
135971|NCT01787461|"~     The study hypothesis is that Imedeen will show effects on skin health, when compared to~     placebo over a 6 month intervention period with respect to changes in skin appearance, skin~     density, moisture, and in fine lines and wrinkles.~   "
135972|NCT01787448|"~     This study is being conducted to determine the potential of Ibuprofen 5% Topical Gel and its~     vehicle gel to cause sensitization after repeated topical application to healthy skin of~     human subjects under controlled conditions.~   "
135973|NCT01787435|"~     The purpose of this study is~        1. To estimate the association between prenatal exposure to proton pump inhibitors (PPIs)~          and the risk of asthma during childhood.~        2. To estimate the association between prenatal exposure to H2-receptor antagonists (H2RAs)~          and the risk of asthma during childhood.~   "
135974|NCT01787422|"~     This study is to determine if telemedicine visits provide similar quality and~     patient/physician satisfaction as traditional office visits in a college health population.~   "
135975|NCT01787409|"~     This partially randomized clinical trial studies cholecalciferol in improving survival in~     patients with newly diagnosed cancer with vitamin D insufficiency. Vitamin D replacement may~     improve tumor response and survival and delay time to treatment in patients with cancer who~     are vitamin D insufficient.~   "
135976|NCT01787396|"~     The objective of this study is to evaluate efficacy and safety of initial combination therapy~     with Gemigliptin 50mg q.d and Metformin q.d compared with either monotherapy in treatment~     naïve patients with type 2 diabetes, In other words, to proof superiority of initial~     combination therapy with Gemigliptin and Metformin than each monotherapy.~   "
135977|NCT01787383|"~     The purpose of this trial is to evaluate the safety of a simultaneous treatment regimen~     compared to a sequential treatment regimen when two separate areas with AKs (one located on~     face/scalp and the other located on trunk/ extremities) are treated with ingenol mebutate gel~   "
135978|NCT01787370|"~     The goal of the flow-mediated constriction/ FMC-registry is to investigate whether the~     measurement of endothelial function using flow-mediated dilation and flow-mediated~     constriction provides on the presence of coronary atherosclerosis and on the prognosis of~     patients undergoing coronary angiography.~   "
135979|NCT01787357|"~     The purpose of this study is to assess the effect of canagliflozin (JNJ-28431754) on~     electrocardiogram results (recordings of the electrical activity of the heart) in healthy~     volunteers after a single therapeutic dose (300 mg) and a single supra-therapeutic dose (4~     times higher [1,200 mg] than the anticipated therapeutic dose of 300 mg). The safety and~     tolerability of canagliflozin will also be assessed.~   "
135980|NCT01787344|"~     To compare the safety and efficacy of Botulax Inj.®(Botulinum toxin type A, Hugel, South~     Korea) with Botox Inj.® (Botulinum toxin type A, Allergan, USA) in the treatment of cerebral~     palsy in children.~   "
135981|NCT01787331|"~     This phase II trial studies how well itraconazole works in treating patients with~     biochemically relapsed prostate cancer. Itraconazole may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth.~   "
135982|NCT01787318|"~     This research study designed to look at how well adolescents' and young adults' blood sugars~     can be controlled with a closed loop artificial pancreas using a continuous glucose sensor,~     an insulin pump, and a computer program that automatically determines how much insulin to~     give based on the glucose level. The investigators will also study the effect of wearing a~     small heating patch, the InsuPatch, at the site of insulin infusion, on the ability of the~     closed loop system to control the blood sugar levels and to reduce the rise in glucose levels~     after meals.~   "
135983|NCT01787305|"~     The purpose of this study is to explore if certain commensals within the gut microbiota (the~     collection of all microbes that live inside the gut) correlate with autoantibodies in the~     autoimmune clotting disorder called antiphospholipid syndrome. The study hypothesis is that~     particular commensals induce the autoantibodies (immune molecules that bind to self~     structures) and thus correlate with the level of immune cells and antibodies that are~     self-reactive. Participants are patients with antiphospholipid syndrome and individuals who~     have tested positive on a prior blood test for anti-beta2-glycoprotein I antibodies or those~     that have tested negative for antiphospholipid antibodies in their blood, but had a clotting~     event or a health problem that puts them at risk to form blood clots.~   "
135984|NCT01787292|"~     The purpose of this research study is to test whether differing levels of physical fitness~     affects patterns of motor dexterity and brain activity that have been shown to differ due to~     aging. Testing will take place at the Atlanta VA Medical Center and at Emory University.~      Participants will be healthy adults within the target age range of 60-85 for the study. The~     study will require multiple visits over 15 months. There will be about 64 people volunteering~     for this study.~   "
135985|NCT01787279|"~     This is an expanded access programme to make Pegasys (peginterferon alfa-2a) available to~     patients with HBeAg-negative chronic hepatitis B in Morocco. Patients will receive Pegasys~     180 mcg subcutaneously weekly for 48 weeks and efficacy and safety will be recorded during~     treatment and for 24 weeks of follow-up.~   "
136023|NCT01786772|"~     To determine changes in quadriceps muscle function following the application of ice and~     compression to the knee.~   "
135987|NCT01787253|"~     Objective: This study aims elucidate the pathophysiological link between the environment in~     the colon (mainly the microbiota), the local immune system and activation of the enteric~     nervous system in patients with post-infectious IBS (PI-IBS) and microscopic colitis (MC)~     with special emphasis on microbial-mucosa interactions and evaluation of the effect on the~     immune activation/response as well as how afferent gut-brain signalling leads to abdominal~     discomfort.~      Method: The project is based on data from three cohorts of patients, one with PI-IBS and one~     with MC as well as a gender- and age-matched cohort of healthy individuals. Measurement of~     perceived sensitivity in the gut will be evaluated by pain-response under mechanical stress~     using a barostat. The HIT (Human intestinal Tissue)-Chip array will be used to characterize~     the diversity, stability and functionality of the intestinal microbiota on mucosa level,~     giving a clue to the interactions with the host and insight to changes leading to the~     development of the two diseases.~      Immunohistochemistry and flowcytometry will be used to analyse the location, frequency and~     phenotype characteristics of lymphoid- and mast cells. Functional analysis of mucosal~     lymphocytes activated in vitro by products from the intestinal microbiota will be examined by~     cytokine production using the LuminexTM system. The Ussing chamber technique will allow~     investigation of the impact of the microbiota and its metabolites on intestinal barrier~     functions. In this method the sample has access to stressors under standard conditions.~   "
135988|NCT01787240|"~     We are doing this research study to find out if people who get better while taking a specific~     kind of antidepressant medication (a selective serotonin reuptake inhibitor, or SSRI) and~     people who get better while taking placebo (an inactive substance) have similar chemicals in~     their brains. Some participants may complete a procedure called Acute Tryptophan Depletion~     (ATD), which is a way to study the role of serotonin in depression. Some participants may~     also undergo a magnetic resonance-positron emission tomography (MR-PET) scan.~   "
135989|NCT01787227|"~     xTAG RPP assay is a PCR-based assay to detect the presence or absence of viral and bacterial~     DNA / RNA in clinical specimens (nasopharyngeal swabs).~      The objective of this study is to establish diagnostic accuracy of the xTAG RPP.~   "
135990|NCT01787214|"~     Persons with type 2 diabetes mellitus (T2DM) have swings in their blood sugar levels that may~     lead to a higher risk of developing heart disease. An important part of diabetes management~     involves eating a diet to prevent large swings in blood sugar levels. Walnuts contain fat,~     protein and fiber that may reduce the swings in blood sugar. The purpose of this study is to~     compare the effects of a walnut-free American Diabetes Association (ADA) diet versus 2 levels~     of walnut-enriched ADA diets on blood sugar swings. Eighteen male and female adults with T2DM~     will participate in the study. Subjects will be randomized to consume an ADA diet with or~     without walnuts for 3 consecutive days every other week. Subjects must test their blood sugar~     twice daily and wear a continuous glucose monitor during the three 72-hour study periods.~     Subjects will be between 40 and 70 years of age and will be recruited from the surrounding~     community using flyers and public service announcements. Consent will take place in the~     Department of Nutrition at Loma Linda University by the study investigators. In total,~     subject participation will last 5 weeks and all meals will be provided during the 3 study~     periods.~   "
135991|NCT01787188|"~     The purpose of this study is to determine whether Meloxicam [Test] Capsules are safe and~     effective for the treatment of osteoarthritis pain of the knee or hip.~   "
135992|NCT01787175|"~     The purpose of this study is to advance the science of healthcare informatics and to improve~     medication management through the development of a new approach to the electronic medical~     record called the Integrated Medication Manager (IMM).~   "
135993|NCT01787162|"~     Goal of the study is to assess the frequency of pulmonary hypertension in patients with~     chronic myeloproliferative diseases. In each patient an echocardiography at rest will be~     performed. In patients without musculoskeletal disease an exercise test (spiroergometry) will~     be performed. Patients with elevated SPAP at rest or with reduced exercise capacity (peak VO2~     < 65%) a right heart catheterization (RHC) will be recommended. Also patients with advanced~     NYHA functional class (III or IV) or with typical PH findings in electrocardiogram will be~     advised to undergo a RHC. Additionally for the evaluation of exercise capacity a 6 MWD will~     be performed.~      This work- up of patients allows clinical and hemodynamic evaluation.~   "
135994|NCT01787149|"~     A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre,~     Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination with DMARDs~     versus DMARDs Alone in Patients with Rheumatoid Arthritis~   "
135995|NCT01787136|"~     Dextromethorphan added on methylphenidate for the patients with attention deficit~     hyperactivity disorder~   "
135996|NCT01787123|"~     This is a randomized, placebo-controlled, single-center clinical trial investigating the~     effectiveness of administrating intravenous Cerebrolysin™ (EVER NEURO Pharma, Austria), a~     preparation of low-molecular weight neurotrophic peptides and free amino acids, in improving~     the functional outcome of patients suffering from aneurysmal subarachnoid haemorrhage ( SAH).~      Cerebrolysin™ is a porcine-derived intravenous formulation composed of multiple lipid-soluble~     active agents that can cross the blood-brain barrier. It is a registered medication in~     several countries indicated for stroke and Alzheimer's disease. It contains several low~     molecular weight neuropeptides and free amino acids that possess neuroprotective and~     neurotrophic properties. It has been proven to arrest or mitigate several crucial steps along~     the ischemic cascade in preclinical studies. Cerebrolysin™ has been extensively investigated~     in patients suffering from Alzheimer's disease, brain trauma and ischemic stroke with~     promising clinical results. It's use in SAH patients has never been investigated and it is~     believed that it may play a role in improving clinical outcomes.~      Consecutive patients aged 18 to 70 years-old diagnosed to have spontaneous subarachnoid~     hemorrhage secondary to a ruptured intracranial aneurysm will be randomly allocated into one~     of two study arms: (1) to receive intravenous Cerebrolysin™ in additional to standard of care~     (intervention group) or (2) to receive usual standard of care alone (control group).~     Permuted-block randomization will be carried out once the eligibility criteria have been~     fulfilled using a computer system with an allocation list of random order. Instructions on~     study arm allocation will be contained in sealed envelopes labeled with sequential study~     numbers. Patients presenting beyond 96 hours after onset of symptoms or if recruitment and~     randomization cannot be performed within this time period will be excluded. The reason being~     that post-SAH arterial vasospasm and delayed cerebral ischemia usually occurs four days after~     aneurysm rupture and lasts for two weeks i.e. 14 days. Should this complication arise before~     Cerebrolysin™ is administered there would be significant confounding of trial outcome~     measures . The timing of intervention is in keeping with several landmark clinical studies~     that have dealt with neuroprotective agents in subarachnoid hemorrhage.~      Patients in the intervention group will receive in a daily total dose of 30ml of intravenous~     Cerebrolysin™. The study medication will be administered in three separate 10ml doses (every~     eight hours) diluted in 0.9% NaCl saline to a total volume of 100 ml as an intravenous~     infusion over a time period of 15 minutes. An identical amount of 0.9% sodium chloride (NaCl)~     saline (100 ml) will be used as placebo for patients allocated to the control study group.~     The total duration of study medication or placebo administration will be 14 days.~      Cerebrolysin™ is a clear yellow solution. Since it is susceptible to photo-degeneration the~     preparation after dilution with 0.9% NaCl saline requires masking with a opaque plastic wrap~     as well as special photo-protective infusion sets. The dilution of the Cerebrolysin™ solution~     will be performed by ward nursing staff . Subjects in both trial groups will receive~     identically wrapped preparations so that both the functional outcomes assessor and patient~     are blind to the study arm allocation.~      In addition to general demographic data, clinical data including the admission Glasgow Coma~     Score, severity grading of SAH, hospital stay as well as the extended Glasgow Outcome Score~     and modified Rankin Score upon discharge, at three months and six months will be~     prospectively collected. The functional outcomes assessor will be an occupational therapist~     unaware of the subject's trial group allocation.~      Hypothesis: compared to patients receiving standard care for the management of aneurysmal~     subarachnoid hemorrhage alone (control), the additional administration of intravenous~     Cerebrolysin™ (intervention) within the acute phase of stroke is safe and improves functional~     outcome at six months after stroke.~   "
135997|NCT01787110|"~     The use of supplemental oxygen in the setting of suspected acute myocardial infarction (AMI)~     is manifested in international treatment guidelines and established in prehospital and~     hospital clinical routine throughout the world.~      However, to date there is no conclusive evidence from adequately designed and powered trials~     supporting this practice. Existing data is conflicting and failing to clarify the role of~     supplemental oxygen in AMI.~      The DETO2X-AMI trial is designed to shed light on this important issue.~   "
135998|NCT01787097|"~     The purpose of the research (or knowledge gap this research is designed to fill) is to~     understand the science of how the combination therapy of 2 drugs (inhaled longacting~     beta-agonists(LABA) and inhaled corticosteroids (ICS), which are commonly used in chronic~     obstructive pulmonary disease (COPD) patients, is better than each drug alone. ICS and LABA~     both have antiinflammatory properties; that is, they dampen the inflammation in the cells of~     the airways in the lungs. The combination of LABA and ICS has also been shown to improve~     clinical effectiveness in asthma patients. The addition of a LABA to LOW doses of ICS has~     been shown to be more clinically beneficial in asthma than the use of HIGH doses of ICS~     alone. This has allowed a reduction in the total ICS dose and minimised the adverse side~     effects of inhaled corticosteroids. Recent evidence suggests that the use of combination~     therapy of LABA and ICS may also improve clinical effectiveness in COPD patients.~      Investigators will address this hypothesis by examining the inflammation cells of COPD direct~     from the site of disease (the airways) by looking at sputum/mucus. This research will build~     on the existing knowledge of the science of how these drugs work in asthma and COPD and~     allows us to understand the molecular science, which may support new future drug targets for~     patients with COPD, which are greatly needed.~   "
135999|NCT01787084|"~     Investigational study of Edwards Lifesciences, LLC's Edwards SAPIEN Transcatheter Heart~     Valve for non-femoral delivery, (or alternative access deliver) in patients with severe~     symptomatic native aortic valve stenosis who have been determined by a cardiac surgeon to be~     inoperable for open aortic valve replacement and in whom existing co-morbidities would not~     preclude the expected benefit from correction of the aortic stenosis. Will outcomes observed~     in a high-risk operable transapical native valve TAVR cohort receiving an Edwards SAPIEN~     device compare to inoperable patients undergoing alternative access TAVR with the Edwards~     SAPIEN device experience a reasonably similar incidence of 30 day adverse events?~   "
136000|NCT01787071|"~     Fluids are one of most common therapies used in critically ill patients. Fluids are the~     cornerstone of hemodynamic management. In overt bleeding, fluids are often given without~     guidance with specific haemodynamic monitoring. In other conditions when hypovolemia may be~     more subtle or when the response to fluids is more variable, fluids are often given in a more~     titrable way, monitoring their haemodynamic impact. This practice, called the fluid challenge~     technique has been proposed by Max Harry Weil more than 30 years ago [1].~      The fluid challenge has been used in several papers and studies assessing the response of~     patients to fluids. The way this practice is performed varies in terms of type of fluid,~     volume of fluid, rate of fluid administration, and clinical endpoints used.~      There is no data that describe how fluid challenges are administered in ICU's across the~     world. Understanding this will provide valuable information regarding current practice and~     would be a basis for improving current practice and future research.~      The way fluids are administered vary widely. Indications for fluids and monitoring of the~     effects are not standardized and may thus lead to heterogeneity in practice. In addition,~     several patients may fail to respond to fluids. The purpose of this observational study is to~     evaluate how fluids are administered and to identify the factors associated with a positive~     response to fluids. Better characterizing these practices and the patients who benefit from~     fluids would set the basis of further interventional trials trying to optimize fluid~     administration.~      What does this study involve?~        1. All patients enrolled in the study will receive standard clinical care~        2. Data will be collected in order to study how fluid challenges are performed in ICU's~        3. No extra tests will be performed for this study~        4. Only measurements and data available as part of clinical practice will be collected~   "
136001|NCT01787058|"~     This study will use longitudinal data collection to quantify the impact of a school-based~     water, sanitation and hygiene (WASH) program in Mali, West Africa, on pupil absenteeism,~     diarrheal illness, and respiratory illness.~      Data will be collected from 100 intervention and 100 control schools across 4 regions in~     Mali. At each school research staff will randomly select 60 pupils in grades 3-6 (typically~     ages 7-14). Research staff will ask school directors to provide written consent for pupil~     participation in place of parents, a procedure that has been approved by the Malian Ministry~     of Education. Research staff will approach selected pupils at school to request informed oral~     assent for participation. The informed assent process and data collection will be conducted~     by local trained enumerators in the child's preferred language of French or Bambara. Oral~     rather than written assent was chosen due to varied literacy capabilities and to limit~     paperwork that identifies participants.~      Data collection will take place at each school once every six to eight weeks during the~     duration of two school years. Research staff will conduct observations of school facilities,~     observations of handwashing behavior of children upon leaving latrines, and an interview with~     the school director about WASH conditions and school enrollment information. None of these~     school activities collect personal data or identifiers. Data collection with pupils will be~     done with the same pupils every 6-8 weeks and entails a 5-minute interview asking about~     recent absence and symptoms of diarrhea and respiratory illness.~      All data collection will occur at the school, will be conducted by trained local enumerators,~     and will be stored on password-protected mobile data collection devices. Data will be~     uploaded to a password-protected server and will not contain personal identifying~     information. Enumerators will maintain a separate form that links pupil IDs with names, which~     will be kept confidential. There are no direct benefits other than contribution to general~     knowledge that will inform future school WASH projects. There are no risks to participation~     other than a small amount of class time missed by pupils, and great efforts will be made to~     minimize time outside of class.~   "
136002|NCT01787045|"~     It is clearly shown that patients in the Intensive care Unit (ICU) with severe sepsis or~     multi organic failure are very susceptible to develop neuromuscular complications. That can~     be attributed to a hyper catabolic state, general inflammation and immobilization. This can~     leads a significant muscle wasting, polyneuropathy and/or myopathy. These alterations have~     been defined with the term Intensive Care Acquired Weakness (ICUAW) and can leads important~     functional squeals and impaired quality of life for months, years and in some cases~     irreversibly.~      To overcome these complications, early activation by physiotherapy becomes an important tool.~     This type of treatment has been show to be feasible, safe and improves the functional~     capacity of patients. In addition to a reduction in the duration of ICU and hospital stay and~     improved quality of life for patients.~      The objective of this study is to demonstrate that the early and active physical activity in~     patients with severe sepsis can limit the loss of muscle mass and complications related to~     this type of damage.~      Procedures: Patients or relatives will be asked to participate in the study. If a positive~     response is done, patients will be randomized in an intervention or control group.~      A baseline evaluation will be performed during the first day of study admission. That~     includes a physical exploration, electrophysiological studies, skeletal muscle~     histological/biochemical evaluations and monitoring of blood biomarkers and others clinical~     outcomes will be registered.~      Intervention will be divided in a morning and afternoon times, patient will be positioned in~     chair or bed and mobilized by physiotherapist. As usual, all patients will be attaining~     manual mobilization for 20 minutes twice a day. Only for intervention group, additional~     cycle-ergometer exercise will be performed for 30 minutes at better performance achieved and~     tolerated for patient. All vitals parameters will be strictly controlled before, during and~     after intervention.~      The same baseline evaluation will be repeated after day 7 and clinical outcomes will be~     registered until ICU discharge.~   "
136003|NCT01787032|"~     The primary objective of this trial is to investigate the relative bioavailability of a~     single oral dose of BI 113608 without and with ketoconazole and voriconazole at steady state.~     The assessment of safety and tolerability of BI 113608 administered alone and upon~     co-administration will be an additional objective of this trial.~   "
136004|NCT01787019|"~     The purpose of the study is to determine if earlier initiation of oral (by mouth as opposed~     to tube) feedings in premature infants results in earlier attainment of full oral feedings~     and/or discharge.~   "
136005|NCT01787006|"~     Esophageal cancer is a highly aggressive tumor. Treatment options are various and range from~     chemotherapy to radiotherapy and several surgical techniques. Nevertheless, the overall~     survival rates for this disease remain poor.~      During the last years the combination of cetuximab with standard chemotherapy or radiotherapy~     has mainly be investigated in clinical trials focusing on colorectal and/or head and neck~     cancer.~      The results obtained from theses studies were very encouraging and led to the initiation of~     active clinical research in esophageal cancer patients with antibody inhibition of the EGFR.~      The first data in this indication are encouraging showing that cetuximab can safely be added~     to chemoradiation for esophageal cancer patients with first hints of efficacy.~      Based on the experiences with cetuximab in colorectal cancer and in combination with~     radiotherapy in head and neck cancer, the aim of the present study is to evaluate the~     feasibility of a combined treatment of cetuximab with continuous infusional 5-FU, cisplatin~     and radiotherapy in patients with esophageal cancer and to assess if the overall survival~     rates can be increased by addition of an EGFR-targeted therapy.~   "
136006|NCT01786993|"~     This IDE study is a prospective, randomized, double-blind, multi-center clinical study to~     evaluate the safety and efficacy of patient treatment with MPP compared to patient treatment~     with standard BiV pacing at 9 months.~      The study will be conducted at a maximum of 50 investigational centers located in the United~     States. A maximum of 506 subjects implanted with the Quadripolar cardiac resynchronization~     therapy device (CRT-D) system will be enrolled in the study.~   "
136007|NCT01786980|"~     Recurrence and metastasis are the main factors affecting the prognosis of liver cancer after~     curative resection. Establishing an effective prognostic evaluation method is able to not~     only assess patients' prognosis but also guide the treatment. At the same time, it helps us~     to gain knowledge of the mechanism underlying recurrence and metastasis of liver cancer and~     to provide the basis for the search for new effective intervention method.~      In order to establish an effective prognostic evaluation method, we select liver cancer~     patients undergoing curative resection in our hospital. We plan to employ various~     technologies such as gene chip, methylation chip and flow cytometry to carry out~     comprehensive researches on liver cancer cell genetics, epigenetics, stem cells and tumor~     microenvironment changes. By analyzing clinical information including pathological features,~     patients' response to treatment, relapse, metastasis and survival, we aim to obtain the~     important factors affecting liver cancer prognosis, survival, recurrence and metastasis in~     order to be able to find and establish the effective prognostic evaluation method.~   "
136008|NCT01786967|"~     Urge urinary incontinence, characterized by unpredictable and embarrassing large volume urine~     leakage, is a major health issue for elderly women, as it is incredibly common and~     significantly impairs quality of life. Although anticholinergic medications are the most~     common therapy, the investigators are unable to predict an individual's response to a~     particular drug in terms of both effectiveness and side effects. Through genetic evaluation,~     the investigators have the potential to personalize and optimize drug therapy for millions of~     elderly women suffering from urge incontinence.~   "
136009|NCT01786954|"~     The purpose of the study is to compare the measurement of pressure inside the eye using three~     different FDA-approved devices (Icare, Tonopen, and Goldmann applanation).~   "
136010|NCT01786941|"~     Elevated circulating levels of certain amino acids (the building blocks of protein) are~     strongly associated with insulin resistance. This study will investigate the metabolism of~     these amino acids in individuals with normal glucose metabolism compared to overweight or~     obese pre-diabetic individuals. The purpose of this study is to determine how elevated levels~     of the branched-chain amino acids may contribute to the development of insulin resistance and~     ultimately diabetes. An additional purpose is to determine whether exercise or gastric bypass~     (GBP) surgery intervention can correct aberrations in branched-chain amino acid metabolism as~     insulin sensitivity improves. This information will be used to further our understanding of~     the development of insulin resistance and type 2 diabetes in at-risk populations and~     potentially improve clinical treatment of such conditions.~   "
136011|NCT01786928|"~     The purpose of this study is to determine whether resistance exercise are effective in~     combating the decline in muscle strength during an exacerbation of Chronic Obstructive~     Pulmonary Disease (COPD).~   "
136012|NCT01786915|"~     The purpose of this study is to assess the study medication blood levels after administration~     of a repeat oral capsules (one capsule each day for seven days) of Bendavia at one of two~     dose levels. The effects of Bendavia on the volunteers will also be assessed.~   "
136013|NCT01786902|"~     Growth hormone therapy will improve the height of idiopathic short statured children.~     DA-3002(Recombinant Human Growth hormone)treated group for 26 weeks, will be compared to~     non-treatment group in efficacy and safety.~   "
136014|NCT01786889|"~     The purpose of this study is to test the feasibility of identifying incident cases of~     angiosarcoma of the liver from the network NetSarc.~   "
136015|NCT01786876|"~     Phase I study to evaluate the excretion of radioactivity, the metabolic profile,~     pharmacokinetics, safety and tolerability following a single oral administration of [14C]~     SPD557 in healthy male volunteers aged 18 to 50 years (inclusive).The purpose of this study~     is to investigate how and how quickly SPD557 or its break down products are excreted by~     analysing blood, faeces and urine samples collected during the study.~   "
136016|NCT01786863|"~     This study is designed to investigate the frequency of Residual Neuromuscular Blockade (RNMB)~     in the pediatric population.~   "
136017|NCT01786850|"~     Patients with unresectable pancreatic cancer in most of cases cannot benefit from~     percutaneous ablation modalities, due to high risk of procedure-related complications.~     Ultrasound-guided high intensity focused ultrasound (HIFU) ablation has been introduced as a~     feasible treatment option in these patients. However, in other anatomical regions US-guided~     HIFU has been replaced by the more accurate MR-guided focused ultrasound (MRgFUS) ablation,~     but the applicability of this latter technique to the treatment of pancreatic cancer is still~     unexplored. The aim of this study is to explore feasibility and clinical performance of~     MRgFUS ablation of unresectable pancreatic cancer. Two are the main end-points: Pain~     palliation and local tumor control.~      As compared to conventional US-guided HIFU, MRgFUS could represent a more accurate,~     non-invasive ablation modality even for unresectable pancreatic cancer although, to date, no~     cases of pancreatic MRgFUS ablation have been reported.~   "
136018|NCT01786837|"~     The purpose of this study is to evaluate the effects of Functional Magnetic stimulation (FMS)~     on gastrointestinal motility in patients suffering from chronic constipation due to~     non-neurological issues.~   "
136019|NCT01786824|"~     The general objective of this open, pilot study is to characterize biological parameters~     related to acute kidney injury among patients undergoing a programmed coronarography with~     injection of contrast material. The study focuses on two main factors that may influence~     acute kidney injury: (1) sodium chloride hydration strategy versus sodium bicarbonate~     hydration strategy and (2) presence of oral L-carnitine treatment versus absence of oral~     L-carnitine treatment. We will also test for a potential interaction between these two~     factors.~   "
136020|NCT01786811|"~     The purpose of the study is to evaluate the impact of implementing a Serious Illness~     Conversation Guide to guide patient/family-clinician discussions and planning about~     end-of-life care decisions. The goal of the intervention is to improve achievement of patient~     care priorities and peacefulness at the end of life for patients with serious and~     life-threatening illness and their families. We hypothesize that patients whose physician is~     trained to use and adheres to the elements of the Serious Illness Conversation Guide will~     demonstrate enhanced consistency between documented key priorities and care received, and~     will experience greater peace in the final month of life; similarly, their families will~     experience higher satisfaction with care.~   "
136021|NCT01786798|"~     The objective of this study is to investigate the role of transvaginal ultrasound in~     detecting endometrial hyperplasia and endometrial cancer in women aged more than 35~     presenting with abnormal uterine bleeding.~   "
136027|NCT01786720|"~     The proposed study will evaluate (for newly diagnosed Chronic Obstructive Pulmonary Disease~     (COPD) patients)the time taken to prescription of triple therapy by aiming to answer these~     following research questions:~        1. The percentage of patients prescribed triple therapy, and when they first started~          receiving triple therapy.~        2. For patients prescribed triple therapy, the time taken to triple therapy from initial~          diagnosis of COPD.~        3. The variation in treatment pathways.~        4. The factors associated with time taken to triple therapy.~   "
136028|NCT01786707|"~     A prospective, open labeled, randomized controlled clinical trial comparing the benefit of~     both hyperbaric oxygen therapy and intrapancreatic stem cell infusion to standard medical~     treatment alone for type 2 diabetes mellitus. Subjects will receive standard medical~     treatment (SMT) with insulin and metformin for 4 months (evaluation phase). Then they will be~     randomized into either the intervention group or the control group:~   "
136029|NCT01786694|"~     The aim of this pilot study is to evaluate the feasibility of microdialysis by laparoscopy in~     order to identify anastomotic leaks after rectal surgery.~   "
136030|NCT01786681|"~     The aim of this study was to investigate the effects of using positive pressure in the~     preoperative, intraoperative and postoperative morbidly obese individuals undergoing~     gastroplasty.~      It is believed that the application of these devices before, during or after surgery can help~     to improve the lungs and reduce pulmonary complications after surgery to reduce the stomach.~   "
136031|NCT01786668|"~     This is the first study of oral tofacitinib in adults with active ankylosing spondylitis. It~     is designed to obtain information on the efficacy and safety of 3 different doses of~     tofacitinib.~   "
136032|NCT01786655|"~     The primary aim of this Phase 1 study is to evaluate the systemic safety of a novel~     prolonged-duration local anesthetic, Neosaxitoxin (NeoSTX), given by subcutaneous injection~     in combination with the commonly used local anesthetic, bupivacaine, and epinephrine.~      The investigators hypothesize that a minimal adverse effect threshold NeoSTX dose for~     subcutaneous administration in combination with bupivacaine 0.2% and epinephrine 5mcg/ml~     respectively, can be defined for awake, young adult healthy volunteer subjects. At the same~     time, the pharmacokinetics of NeoSTX when delivered subcutaneously will be determined.~   "
136033|NCT01786642|"~     The aim of the present study is to measure the time to correction of O2 saturation when in~     case of desaturation below 90%, O2 administration is switched from the nasal to the tracheal~     route at a similar flow rate.~   "
136034|NCT01786629|"~     To compare the safety, tolerance and efficacy of SUPREP Bowel Prep Kit to an FDA approved~     control as bowel preparations prior to colonoscopy in adult patients.~   "
136035|NCT01786616|"~     Polymorphism at codon 16 of the beta2-adrenoceptor (beta2-AR) affects the responsiveness to~     salmeterol in asthmatics. Data concerning formoterol are more controversial in literature.~     The aim of this study was to verify whether homozygote for arginine-16 (ArgArg16) and~     homozygote for glycine-16 (GlyGly16) genotypes differently influence the long-term~     responsiveness to formoterol.~   "
136036|NCT01786603|"~     ALS is a disorder that weakens motor strength and lung function. Rapid loss of motor neurons~     in the brain and spinal cord of ALS patients causes the symptoms of increasing weakness and~     loss of muscle function. Motor neurons are responsible for sending signals to muscles in our~     bodies to trigger movement. While there are drugs to help relieve symptoms of ALS, there is~     no cure for ALS.~      Rasagiline is a drug with possible neuroprotective characteristics. Neuroprotective means~     that the nervous system may be protected against weakening. It is known that rasagiline has~     possible neuroprotective characteristics, but the effectiveness of rasagiline for patients~     with ALS has not been tested. Rasagiline is approved for the treatment of Parkinson's~     disease.~      Rasagiline for treatment of ALS is not approved by the U.S. Food and Drug Administration~     (FDA) and is investigational. Investigational drugs are studied to find out if they are safe~     and effective in the treatment of diseases or conditions.~      By doing this study, researchers hope to learn if rasagiline is safe and slows disease~     progression in patients with ALS.~      Funding Source - FDA OOPD.~   "
136037|NCT01786590|"~     It is reported that more than 90,000 patients died of lung cancer and more than 20% of them~     were older than 80 years in North America. Therefore a less invasive but effective treatment~     is required for patients with lung cancer of advanced age, diminished pulmonary functions,~     and chronic diseases. Stereotactic body radiation therapy (SBRT) is an effective and~     well-tolerated treatment for early stage lung cancer in medically inoperable patients. On the~     other hand, accurate mediastinal and hilar lymph node staging is one of the most important~     factors that determine the outcome and indications for SBRT. Endobronchial ultrasound-guided~     transbronchial needle aspiration (EBUS-TBNA) is a novel, minimally invasive modality that~     enables the assessment of mediastinal and hilar lymph nodes with a high sensitivity. Accurate~     lymph node staging by EBUS-TBNA will allow opportunities for high-risk patients with lung~     cancer to undergo minimally invasive treatment.~   "
136038|NCT01786577|"~     The purpose of the study is to examine specific neuroimaging predictors of memory and~     executive decline in older adults at various stages after total knee replacement surgery.~   "
136039|NCT01786564|"~     The purpose of this study is to determine if deficient sleep and/or disruption with the~     body's internal clock (circadian rhythms) are associated with diabetes risk. This study is~     being done to look at the possible relationships between sleep and risk of diabetes by~     examining sleep in the home and diabetes risk in the laboratory.~   "
136051|NCT01786408|"~     This study will involve an investigational device, the Seventh Sense Biosystems TAP20-C. The~     TAP20-C device collects small amounts of blood from the forearm which can then be used for~     blood testing. The study will also involve collecting blood by fingerstick which is a common~     way of collecting blood. The SAFE-T-FILL Capillary Blood Collection system and the Terumo~     Capiject 1.5 mm Blade Safety Lancet will be used for this. The study will compare the~     concentrations of glucose, hemoglobin, and HbA1C in blood samples collected with the two~     different blood collection methods. Additional information will be collected about how the~     TAP20-C device performs.~   "
136074|NCT01786109|"~     Irritable bowel syndrome (IBS) affects about 15% of the U.S. population. There are still no~     effective and safe medications approved for the treatment of abdominal pain associated with~     bowel symptoms in IBS. This study will investigate the effects of an approved medication,~     Dronabinol, on the movement of food through the stomach and colon in subjects with a history~     of diarrhea-predominant Irritable Bowel Syndrome (D-IBS).~   "
136040|NCT01786551|"~     The purpose of this study is to investigate the effect of mineralocorticoid receptor (MR)~     blockade in healthy participants in a systemic proinflammatory state after a meal high in fat~     and glucose, which is associated with the pathogenesis of atherosclerosis.~      Participants will include normal-weight, healthy males (Body Mass Index (BMI) ≤ 25 kg/m^2)~     between the ages of 18-45, without hypertension and clinical evidence of metabolic,~     cardiovascular or any other kind of diseases. After a 12-hour (h) fast, participants will be~     assigned to a combination of oral fat-loading test (OFLT) and oral glucose tolerance test~     (OGTT) (day 1), followed by a two-week treatment with 50 mg eplerenone. After two weeks,~     participants will receive the second OFLT/OGTT treatment (day 15). Starting 5 days prior to~     the first intervention (day1), the participant's usual diet (ad lib) will be supplemented~     with 2 bullion broths each day. Standardization of sodium intake is necessary as variations~     in dietary sodium intake may affect outcome measures. We will evaluate the following~     parameters at day 1 and day 15 of the study. Prior to OFLT/OGTT, and 2h, 4h thereafter, we~     will measure a parameter of vascular and systemic inflammation: interleukin-6 (IL-6).~   "
136041|NCT01786538|"~     Regorafenib has been proved to improved survival in patients with metastatic colorectal~     cancer who have been failed to all of known standard chemotherapy (The CORRECT study). The~     phase Ib study of regorafenib plus FOLFOX or FOLFIRI was performed and the dose of~     regorafenib was fixed; 160 mg/day on days 4 to 10 (7 days per cycle when combined with FOLFOX~     or FOLFIRI). Regorafenib plus FOLFOX as second-line chemotherapy in mCRC patients who~     progressed after first-line irinotecan-based chemotherapy has not been studied yet, and~     because there have been unmet needs for the discovery of valid targeted agent combination for~     the second-line FOLFOX as above reasons, the investigators planned this study of regorafenib~     plus FOLFOX as second-line chemotherapy in mCRC patients who progressed after first-line~     irinotecan-based chemotherapy.~   "
136042|NCT01786525|"~     The main purpose of this research program is to reduce the burden of end-stage organ disease~     on individuals, families, healthcare systems, and society by increasing the availability of~     donor organs for transplantation. Consistent with this aim, the project further examines~     strategies to increase access to and reduce disparities - racial, economic, gender - in live~     donor kidney transplantation (LDKT). Specifically, we expand the research and intensity of an~     innovative House Calls intervention developed by the principal investigator by including~     other minorities and socioeconomically disadvantaged patients and by adding a novel~     Patient-Centered Decision Support component. The main study hypothesis is that participants~     receiving the novel intervention (House Calls + Patient-Centered Decision Support) will have~     a higher proportion of LDKT's by the 2-year study endpoint.~   "
136043|NCT01786512|"~     The primary objectives of this study are (i) to select an oral modified release (MR)~     formulation and dose of omecamtiv mecarbil for chronic twice daily (BID) dosing in subjects~     with HF and left ventricular systolic dysfunction and (ii) to characterize its~     pharmacokinetics (PK) over 20 weeks of treatment.~   "
136044|NCT01786499|"~     Hypothesis: Relaxation Response training is an effective intervention in reducing the~     prevalence and severity of burnout and its components from baseline levels among physicians~     receiving the training intervention. The intervention is hypothesized to moderate the~     relationship between Areas of Worklife (AWS) and burnout by improving physician's ability to~     cope with the demands of their workplace. This increased coping ability is hypothesized to~     reduce burnout.~      Physician practices are as unique as the individual practitioners and the environment in~     which they practice. Traditional instruction of relaxation or self-care techniques has~     required participants to travel to locations remote from the workplace. The time commitment~     required for this behavior is additive to the time required to learn the intervention and of~     itself may induce extra stress increasing the potential for burnout. This study proposes that~     bringing the intervention to the workplace will increase provider willingness to participate~     and diminish the stress introduced by deployment of the intervention. Since inpatient and~     outpatient medicine have different practice characteristics and demands on the time of the~     practitioners, this study will need to develop and test the logistics necessary to bring the~     training to the different physician populations.~   "
136045|NCT01786486|"~     The objective of the AMPLATZER Cardiac Plug (ACP) Registry Long Term Follow-up study is to~     evaluate long term performance of the ACP in closure of the Left Atrial Appendage (LAA) in~     subjects with nonvalvular atrial fibrillation and assess adverse events up to two (2) or more~     years post implant.~   "
136046|NCT01786473|"~     The purpose of this study is to evaluate the safety and efficacy of Testogel® 50mg/5g gel~     administered once daily (QD, morning dosing) compared to placebo administered once daily (QD,~     morning dosing), for 3 months, in hypogonadal men with testosterone deficiency being~     confirmed by clinical features and biochemical tests. For men with hypogonadism, treatment~     aims to restore testosterone levels to normal physiological range.~   "
136047|NCT01786460|"~     The purpose of this study is to use an investigational assay to assess levels of putative~     biomarkers of traumatic brain injury (TBI) in a general population. The data will be used in~     a correlative analysis with data collected under a separate study of severe TBI.~   "
136048|NCT01786447|"~     The purpose of this study is to determine if specific brain injury biomarkers have utility as~     blood-based traumatic brain injury (TBI) diagnostic and monitoring tools. This will be~     accomplished by examining the relationships between potential serum-based TBI biomarkers and~     clinical measures of injury severity, occurrence of complications, and outcome, in subjects~     with mild or moderate TBI as well as in orthopedic control subjects.~   "
136049|NCT01786434|"~     Colonoscopy may be an unpleasant procedure. Sedation and/or analgesics is therefore routinely~     administered in most countries. In Norway, however, routine sedation is rare, and medication~     is normally given on demand, that is, if necessary during the procedure. The investigators~     want to evaluate whether the effect of fentanyl, a synthetic opioid with fast onset of~     action, is better given before the procedure than during the procedure.~   "
136050|NCT01786421|"~     The purpose of this study is to determine the impact of alcohol consumption in diurnal~     triglyceridemia in a free living situation.~   "
136064|NCT01786239|"~     This 16-week placebo-control study looks to investigate whether patients with schizophrenia~     for two years or less may benefit from omega-3 supplements.~   "
136052|NCT01786395|"~     This study is a multicenter trial performed in Japan, consisting of a comparative study~     period and a continuous administration period.~      Effect of 0.15% UF-021 eye drops on improvement in central retinal sensitivity with HFA will~     be verified in 52 weeks comparative study period by a placebo-controlled, double-masked study~     in patients with retinitis pigmentosa.~      The safety of same eye drops will also be examined in 52 weeks continuous administration~     period, in all the patients who completed the comparative study period.~   "
136053|NCT01786382|"~     The primary objectives of the study are to:~        -  Evaluate the potential effects of PPI-668 at steady state on the pharmacokinetic (PK)~          profile of midazolam following a single oral dose in human subjects.~        -  Evaluate the potential effects of PPI-668 at steady state on the PK profile of~          omeprazole following a single oral dose in human subject~   "
136054|NCT01786369|"~     This is a screening study aimed at estimating the frequency of antipsychotic non-compliance~     in patients with a history of schizophrenia or other psychotic disorder admitted to an~     inpatient psychiatric unit. Levels of the antipsychotics risperidone, olanzapine, quetiapine,~     aripiprazole, and paliperidone will be drawn in patients presenting the emergency room who~     are acutely psychotic, require admission to an inpatient hospital, have a history of~     psychosis, and have previously been prescribed one of the study drugs. Levels will then be~     analyzed to determine the frequency and severity of non-compliance in this population.~   "
136055|NCT01786356|"~     Age-related cataract is the main cause of impaired vision in the elderly population~     worldwide.~      The only treatment that can restore functional visual ability is cataract surgery where the~     opacified crystalline lens is removed by phacoemulsification and an artificial intraocular~     lens is implanted into the remaining capsular bag. Cataract operations are generally very~     successful, with a low risk of serious complications.~      The most common reason for impaired vision after uneventful cataract surgery in otherwise~     healthy eyes is the development of posterior capsule opacification (PCO). PCO is a~     physiological change (thickening, opacification and clouding) of the capsular bag expected~     after cataract surgery, because the lens epithelial cells (LECs) undergo hyperplasia and~     cellular migration. PCO is treated with Nd:YAG capsulotomy, a quick outpatient procedure that~     uses a laser to open a central hole in the posterior capsular bag.~      Modifications in IOL design and material lead to a decrease in the incidence of PCO.~      During the past two decades, refinements in surgical technique were made resulting in today's~     small incision phacoemulsification surgery. Nowadays a multitude of microincision IOLs are~     available, many of them similar but of course with some differences in regard to the chemical~     composition of the acrylic material and the IOL design.~      The purpose of this study is to compare the development of posterior capsule opacification~     (PCO) and the frequency of treatment between two different microincision IOLs over a period~     of 4 years.~   "
136056|NCT01786343|"~     The goal of this clinical research study is to compare how well 2 different dosing schedules~     of decitabine may help control AML.~      Decitabine is designed to damage the DNA (the genetic material) of cells, which may cause~     cancer cells to die.~   "
136057|NCT01786330|"~     This is a pilot study investigating the use of abdominal binders after cesarean sections. The~     researchers are testing whether elastic abdominal binders improve postoperative pain control~     and reduce postoperative blood loss. Blood loss and pain control are both concerns after~     giving birth. It is hoped that the use of an abdominal binder after giving birth will provide~     a non-pharmacologic way to to reduce blood loss and manage pain.~   "
136058|NCT01786317|"~     Traditionnal measurment of anorectal function is perfomed with manometric device using 2 to 3~     pressure sensors. The investigators aim to evaluate the usefulness of high resolution~     manometry to measure anorectal motility~   "
136059|NCT01786304|"~     Sacral nerve stimulation (SNS) is a new therapeutic option to treat fecal incontinence,~     although its mecanims of action remains poorly understood. The investigators hypothtized that~     SNS could act on enteric nervous system (ENS). To verify this hypothesis, the investigators~     will collect biopsy samples from patients implanted for SNS, and assess whether SNS induces~     changes in ENS.~   "
136060|NCT01786291|"~     Positive airway pressure (PAP) therapy is generally offered to patients with obstructive~     sleep apnea. The investigators suggest that beneficial effects of PAP therapy is by~     preventing apneas and therefore reducing cardiac and pulmonary morbidities. The investigators~     sought to verify this by assessing cardiac and pulmonary function during exercise.~   "
136061|NCT01786278|"~     The objective of the study is comparison of the efficacy and safety of palliative therapy~     with single-dose brachytherapy or selfexpanding metal stents (SEMS) in malignant dysphagia~     resulting from adenocarcinoma of the esophago-gastric junction.~   "
136062|NCT01786265|"~     The goal of this clinical research study is to learn if treatment with hormone therapy in~     combination with abiraterone acetate and prednisone for 8 months controls the disease better~     than treatment with standard hormone therapy alone.~      Abiraterone acetate is designed to decrease the production of testosterone (male sex~     hormones), which plays a role in causing prostate cancer to grow.~      Prednisone is commonly used to treat prostate cancer and is given along with abiraterone~     acetate treatment to help lower or prevent some side effects.~   "
136063|NCT01786252|"~     Worldwide, 1 in 12 couples experience difficulty in getting pregnant and seek the help of~     assisted reproductive technologies (ART) such as in vitro fertilization (IVF-egg is~     fertilized by sperm outside the body), ovarian stimulation (medications are used to stimulate~     egg development) and intra-cytoplasmic injection (ICSI-single sperm is injected directly into~     the egg).~      Regardless of the ART procedure being performed, the newly fertilized embryo must still~     implant into the mothers endometrium (inner lining of uterus). This implantation process in~     humans is surprisingly inefficient and accounts for up to 50% of ART failures. Intrauterine~     infusion of hCG prior to embryo transfer has recently been shown to increase pregnancy rates~     but the cellular mechanism for this increase is unknown.~      Successful implantation requires the newly fertilized embryo and the endometrium develop in a~     synchronized manner. This coordinated development is accomplished, in part, by proteins~     secreted by the embryo which circulate throughout the maternal bloodstream and alert the~     maternal body organs (i.e. ovary, endometrium, breast, ect) that fertilization has occurred.~      One of the earliest of these secreted proteins is human chorionic gonadotropin (hCG), which~     is the molecule detected in over-the-counter pregnancy tests. From previous studies, we know~     that hCG production by the embryo alerts the ovary to continue producing progesterone, a~     hormone required for pregnancy. However, very little is known about the direct effect of hCG~     on the endometrium during early pregnancy in humans.~      Using animal models, hCG has been shown to induce specific changes in the endometrium,~     suggesting that embryo-derived hCG may be priming the endometrium in anticipation of~     implantation. The goal of this research study is to examine the direct effect of hCG on the~     human endometrium and see if this priming effect is also present in humans. Findings from~     this research may reveal whether pre-treatment with hCG can enhance ART outcomes, especially~     pregnancy rates.~   "
136066|NCT01786213|"~     Colon cancer is the second most common cause of death among cancer-related deaths in Germany.~     Precancerous lesions such as adenomas can be detected efficiently by colonoscopy. To provide~     high quality in colonoscopy several quality parameters have been postulated in the past. The~     adenoma detection rate (ADR) is one of those parameters. Empirical data suggest that a~     detection rate of 20% should be demanded. Detection rates are influenced by a multitude of~     circumstances such as bowel cleanness. The facts that detection rates vary between~     colonoscopists suggests that leaning effects may also play a role. It is not known how ADR~     and other quality parameters evolve while trainees improve their skills in colonoscopy. The~     investigators postulate that a learning curve exists. The investigators therefore plan to~     evaluate chronologically the findings of trainee colonoscopists. A particular performance in~     detecting adenomas shall be calculated in relation to the amount of examinations performed.~   "
136067|NCT01786200|"~     This prospective pilot study will examine whether the previously reported effects of NSAIDs~     on colorectal cancer may be modulated through alterations in tissue gene expression, up~     regulation of local immune cell infiltrates or down-regulation of the systemic inflammatory~     response.~   "
136068|NCT01786187|"~     Little is known about the symptom experience of persons having undergone surgery for lung~     cancer. What we do know is that symptoms are common and can become severe and lasting. The~     main purpose of this study is two-fold:~        1. To better understand the symptom experience of persons with lung cancer prior to surgery~          and for up to six weeks after returning home from the hospital.~        2. To examine the role of a light physical activity program in persons who are undergoing~          surgery for lung cancer for the treatment of a specific symptom.~      The goals of this study include:~        -  Collecting information about the participant's current and prior health history,~          symptoms, and health-related quality of life.~        -  Assessing our ability to recruit participants to the study.~        -  Assessing participant's level of participation.~        -  Evaluating the participant's satisfaction with the program.~      We expect that patients after undergoing surgery for lung cancer during the recovery process~     will experience multiple symptoms. We also expect to find that a light intensity physical~     activity program will be feasible, acceptable, and show a positive impact on symptoms such as~     cancer-related fatigue and confidence for cancer-related fatigue self-management.~      Information gained from this randomized controlled trial study will be used to refine the~     design of future larger-scale studies targeting symptoms such as cancer-related fatigue for~     the lung cancer population.~   "
136069|NCT01786174|"~     The purpose of this study is to determine whether Gilenya, also known as fingolimod, is safe~     and tolerable in patients with Amyotrophic Lateral Sclerosis (ALS).~   "
136070|NCT01786161|"~     Vancomycin is an essential antimicrobial which is frequently used in the ICU for suspected~     methicillin-resistant Staphylococcus aureus (MRSA) infection. Therefore, it is vital to~     optimize the dosing of vancomycin for this critically ill population. The most efficacious~     method of administering vancomycin is debated in the literature. Since vancomycin is~     associated with slow bactericidal activity, it is important to closely monitor serum~     concentrations so as to achieve early target serum concentration, particularly when treating~     aggressive S. aureus infections. One study has shown that vancomycin infused continuously may~     enable faster and more consistent achievement of a therapeutic serum concentration when~     compared to intermittent infusion. A faster achievement in the goal serum vancomycin~     concentration would be a protective factor for intensive care unit mortality in patients with~     MRSA infection.~      Currently in the surgical ICU (SICU) of our institute, vancomycin is administered based on a~     vancomycin dosing nomogram. Less than fifty percent of the ICU patients following this~     nomogram achieved target vancomycin concentration of 15 after 24 hours. To better achieve~     target vancomycin concentration in 24 hours, we developed a new vancomycin dosing nomogram~     with a continuous infusion. The aim is to determine which of the two dosing nomogram is more~     efficient and safer for SICU patients.~   "
136071|NCT01786148|"~     The overall goal of this project is to use technology to improve adherence to antiretroviral~     therapy (ART)and increase access to ART adherence care for those HIV+ persons living in rural~     areas. The LIVE Network audio music program mobile application (app) is innovative,~     practical, portable, and could be rapidly scaled up to address the adherence self-management~     needs of rural groups nationwide. If successful, the impact on HIV care will be immense and~     could transform the delivery of HIV self-management and adherence education by overcoming~     barriers of geographic isolation, transportation, stigma and confidentiality in this~     vulnerable group.~   "
136072|NCT01786135|"~     This is a phase 1, open-label, dose-escalation, multicenter study to evaluate the safety and~     tolerability of SGN-CD19A in patients with relapsed or refractory B-lineage non-Hodgkin~     lymphoma (B-NHL)~   "
136073|NCT01786122|"~     AIM: To evaluate the effectiveness and efficiency of an innovative exercise program (EP) for~     patients during treatment for gastrointestinal tumors, breast and non small cells lung~     cancer, in terms of improved quality of life (QOL), fatigue and functional capacity respect~     the usual standard treatment (ST). DESIGN: Pragmatic randomized clinical trial in two~     parallel groups: EP and ST. SETTING: 7 Primary Health Centers (PHC) of the redIAPPISCIII, in~     coordination with oncology services. PARTICIPANTS: 250 patients with the above tumors,~     locally advanced or with metastatic disease, in adjuvant treatment, with Performance~     Status(PS) PS1-PS0. INTERVENTION: Both groups received standardized usual care. The EP group~     will receive, in addition, a nurse supervised exercise program for 2 months in the PHC and a~     second phase in community facilities during the remaining 10 months. MEASUREMENTS: The~     primary outcome measure is the change from baseline in the QOL+66 treatment, as measured by~     the specific questionnaire for patients with cancer EORTC QLQ-C-30 and Short Form(SF-36)~     overall. Secondary: fatigue (FACIT-F), radiological response, functional capacity (6 minutes~     walking and cardiopulmonary test), muscle strength and progression-free survival and overall.~     Predictors and confounders: age, sex, stage and tumor type, histology, treatment. ANALYSIS:~     We will compare between groups mean changes from baseline measurement of quality of life~     questionnaire (QOL) and other variables, on an intention to treat basis, using longitudinal~     mixed-effects models for repeated measures at 2, 6 and 12 months follow-up. Cost /~     effectiveness and cost / incremental utility associated to the program wil be estimated.~   "
146193|NCT01653509|"~     This study will treat approximately 24 participants who experience cold sores. Patches will~     be applied to the cold sore for up to ten days, and the symptoms will be measured during~     daily clinic visits using non-invasive measurement techniques.~   "
136076|NCT01786083|"~     The purpose of this study is to evaluate the effectiveness of the Problem Solving Technique~     (PST) in reducing symptoms of anxiety and depression among primary caregivers of chronically~     ill patients.~      And also to describe and evaluate the process carried out by nurses when implementing the PST~     as a useful tool for care for family caregivers.~   "
136077|NCT01786070|"~     The aim of this study is evaluation of the effect of administration nebulized budesonide~     after extubation. The specific objectives of our study are to determine whether multiple~     doses of nebulized budesonide are effective to reduce or prevent postextubation edema.~      In this double-blind randomized clinical trial study, 70 patients (age between 18 to 65) who~     are intubated (at least for 48 hours) and now are ready for extubation will be enrolled in~     the study after obtaining a written informed consent from their parents or guardians.~      The investigators divide our patients randomly into two equal groups.~      -Patients who are in budesonide group will receive nebulized budesonide (1 mg-every 12 hours;~     n=35) and patients in placebo group receive placebo (normal saline; n=35) until 48 hours~     after extubation. If patient have extubation criteria the investigators will extubate him and~     for 24 hours after, another anesthesiologist who is unaware about kind of medication, will~     evaluate the patients for severity of stridor. We will record the vital sings and grade of~     stridor every 6 hour. Respiratory rate (RR), heart rate (HR), blood pressure (BP) and oxygen~     saturation (SPO2) were recorded for each patient immediately before aerosol administration~     (time 0) and at 30 and 60 min; and 2,4,8,12,24,36 and 48 hrs. After extubation then the~     presence of stridor (heard with the aid of stethoscope) was recorded within 48 hr of~     extubation.~   "
136078|NCT01786057|"~     Plantar fasciitis is one of the most common causes of heel pain. This study will be performed~     in the purpose of determination the effects of extracorporeal shock wave therapy of~     gastrosoleus trigger points in patients with plantar fasciitis~   "
136079|NCT01786044|"~     The purpose of this study is to assess the effects of an interactive educational program~     delivered through a patient portal on patients' medication knowledge and medication~     adherence.~   "
136080|NCT01786031|"~     Toward personalised treatment in early metastatic prostate cancer based on the assessment of~     biomarkers in cancer tissue samples and circulating tumour cells.~   "
136081|NCT01786018|"~     The purpose of this study is to evaluate progression free survival, transplant-related~     morbidity (TRM) at day +100 and at +365, overall survival and incidence of acute and chronic~     GVHD in refractory/early relapsed aggressive B-cell non Hodgkin lymphomas patients treated~     with allogeneic Transplantation after a conditioning with Thiotepa, Busulfan and fludarabin.~   "
136082|NCT01786005|"~     Spasticity - movement disorder, which is part of the syndrome of defeat top motor-neuron,~     characterized by the rate-dependent increase in muscle tone and increased dry-core~     reflections from hyperexcitability of stretch receptors (Lance, 1980). Spasticity - a~     frequent symptom of neurological diseases (Valero-Cabre, Pascual-Leone, 2005) and may be~     accompanied by such a disorders consequences of stroke, multiple sclerosis, head trauma and~     spinal cord, cerebral palsy, etc. The magnitude and severity of spasticity depends on the~     level of the lesion, the duration of its existence from the time before the disease, and~     possible plastic changes in axons and synapses on the affected level. There are two basic~     models of spasticity: cerebral (hemiplegic) and spinal (paraplegicheskaya) (Nikitin, 2005).~     Cerebral model appears with the direct injury of the brain and is characterized by increased~     excitability of monosynaptic reflexes with the rapid development of pathological ref-plexes~     and characteristic hemiplegic posture. Model is characterized by spinal spasticity opposite~     lower segmental inhibition polysynaptic reflexes slow increase of nervous excitability due to~     the mechanism of cumulative excitation perevozbuzhdeniem flexor and razgibate-ing, as well as~     expansion of the area of segmental responses (Nikitin, 2005). As spinal and cerebral~     spasticity are extremely difficult corrected by standard medical clinic and physiotherapy~     methods. In this regard, in the world literature actively searched for addi-tional search~     correct this symptom. A new modern methods that could affect the syndrome of spasticity is~     rhythmic transcranial magnetic stimulation (Mori et al., 2009).~   "
136083|NCT01785992|"~     70% of breast cancers that occur in postmenopausal women rely on the hormone oestrogen to~     grow and are likely to respond to hormone treatment. This type of treatment reduces the~     amount of oestrogen in the body, slowing the growth of cancer or stopping it altogether. One~     type of hormone treatment, aromatase inhibitors (AIs), works by stopping the body from making~     oestrogen. Currently, women with locally advanced or metastatic breast cancer that is not~     being controlled by one class of AI are switched to the other class of AI. The reason for~     this is that some cancer cells can become resistant to one class but are still sensitive to~     the other class. However, oestrogen can be made in the body by two pathways and AIs block~     only one of these pathways. A new drug called Irosustat can reduce the production of~     oestrogen in the body by blocking the second pathway. This study is investigating whether~     adding Irosustat to AI treatment i.e. blocking both pathways at the same time, can further~     reduce the amount of oestrogen in the body and therefore control the breast cancer better.~      27 postmenopausal women with oestrogen receptor positive locally advanced or metastatic~     breast cancer that is not being controlled by their current AI treatment will be recruited in~     this study from 9 United Kingdom (UK) hospitals. Eligible patients will receive 40mg of~     Irosustat once daily in addition to the AI on which they progressed. Patients will receive~     Irosustat for as long as it controls their cancer or until they have side effects that stop~     them from taking treatment. Patients will be seen monthly for the first 6 months and every 3~     months thereafter. Participating patients will also be given the option to take part in the~     exploratory part of this study by donating tissue and blood samples.~   "
136084|NCT01785979|"~     This randomized clinical trial will address a complication related to recurrent episodes of~     malaria in endemic areas - hyper-reactive malarial splenomegaly. We aim to assess the~     efficacy of chloroquine after prednisone-induction therapy compared to standard treatment of~     chloroquine alone in the treatment of adult patients with newly diagnosed hyper-reactive~     malarial splenomegaly.~   "
136085|NCT01785966|"~     CHECKLIST-ICU will be a cluster randomized trial to ascertain whether the use of an~     intervention including 1) checklists with assessment of daily goals during the~     multidisciplinary visit, and 2) clinician prompting can reduce in-hospital mortality of~     patients admitted to intensive care units (ICUs).~      The investigators also aim to describe participant ICUs in terms of the standards for~     intensive care units proposed by the Brazilian National Health Agency (ANVISA).~   "
136086|NCT01785953|"~     The purpose of this study is evaluate patients with acute myeloid leukemia (<=66 years),~     treated with conventional and experimental chemotherapy following allogeneic transplantation.~     THis patients have been enrolled from 2000 to 2011 at the Division of Hematology, Molinette~     University Hospital. The purpose of data collection is to assess, with retrospective~     analysis, the clinical outcome divided by risk class and evaluated in patients who achieve~     complete remission after induction therapy and consolidation.~   "
136087|NCT01785940|"~     Total shoulder surgeries are associated with considerable postoperative pain which may~     prevent rehabilitation and early discharge from the hospital. Continuous interscalene blocks~     with home infusions are commonly performed for pain relief following total shoulder~     arthroplasties. We want to evaluate the time to readiness for discharge following~     interscalene blocks in patients undergoing total shoulder arthroplasties.~   "
136088|NCT01785927|"~     The inhaled route of delivery has always been associated with the considerable challenge of~     getting the drug to its target. The lungs are a highly complex organ designed to filter~     inspired air, with many different cell types contributing to their function. Furthermore, the~     lungs may change dramatically when afflicted by disease resulting in an internal environment~     that works against the drug reaching and interacting successfully with the target. For~     targets in the upper airways this will have lesser significance, but drug delivery to the~     deep lung may be impeded by changes such as mucus hyper-secretion or thickening or airway~     narrowing.~      In order to interpret toxicology findings it is necessary to reconcile test sensitivity,~     background biological variation, normal responses to inhaled materials and drug or~     medicine-specific adverse effects. Identification of adverse end-points is an area where~     better control data sets might help discern true adverse effects from a normal physiological~     lung response. The lung responds acutely to inhalation of irritant materials by~     hyper-secretion of mucus, chemokine release, inflammatory cell recruitment and cough and~     collectively these may be characterized as non-specific irritancy.~   "
136089|NCT01785914|"~     This study provides for the collection of a series composed by patients with newly diagnosed~     of acute lymphoblastic leukemia in the period 1999-2011. This collection is carried out with~     retrospective investigation, through the review of paper and electronic records and data~     cards in large part already collected as part of study protocols GIMEMA or BFM or NILG~     approved by the Ethics Committee of Hospital. The purpose of data collection is to check with~     retrospective predictability of classical risk factors in relation to disease response, and~     overall survival of the event-free survival, to estimate the cumulative incidence of~     competitive events such as the emergence of disease, acute and chronic transplant, the~     transplant-related mortality and relapse of disease.~   "
136090|NCT01785901|"~     This is a multi-centre, cross-sectional study planned to be conducted in China. The study~     aims to observe about 1500 asthma patients who have already received budesonide/formoterol~     combination treatment by physicians' determination and whose medications are aligned with the~     package insert of budesonide/formoterol approved in China.~   "
136091|NCT01785888|"~     This is a non-interventional diagnostic, international, multicenter and non-comparative study~     of EGFR mutation status in aNSCLC patients (locally advanced and/or metastatic disease) with~     adenocarcinoma and non-adenocarcinoma histologies. This study will be conducted in Japan and~     Europe and will assess the concordance of EGFR mutation status derived from tumour samples~     and blood based circulating free DNA. The data generated will inform the use of less-invasive~     sample types in diagnostic practice. The study also aims to assess the current status of EGFR~     mutation testing across Japan and Europe and gaps in currently available data including EGFR~     mutation frequency in particular populations and demographic subgroups, EGFR mutation~     frequency in histological subtypes of NSCLC, EGFR mutation test process and methodology,~     utility of multiple sample types in the assessment of EGFR mutation status, and impact of~     EGFR mutation status on therapy choice. The data may be used to drive improvements to the~     EGFR mutation testing process, ensuring that patients have access to testing and are treated~     appropriately on the basis of the molecular features of their disease.~   "
136092|NCT01785875|"~     This study is designed to describe the long-term safety and efficacy of etelcalcetide (AMG~     416) for the treatment of SHPT in adults with CKD on hemodialysis.~   "
136093|NCT01785862|"~     The purpose of this study is to evaluate the efficacy and safety of repeated doses of a low~     dosage of oromucosal Ibuprofen form (lozenge) versus placebo in patients suffering from acute~     sore throat pain.~   "
136094|NCT01785849|"~     This study is designed to assess the efficacy and safety of etelcalcetide compared with~     placebo in the treatment of SHPT in patients with chronic kidney disease (CKD) receiving~     hemodialysis.~   "
136095|NCT01785836|"~     This study will assess the safety, tolerability, and efficacy of dapsone in subjects with~     acne vulgaris following 12 weeks of treatment.~   "
136096|NCT01785823|"~     We investigated the efficacy and the safety of the pharmacokinetic model-based~     patient-controlled analgesia (PCA) regimens of fentanyl for postoperative analgesia after~     total intravenous anesthesia (TIVA).~   "
136097|NCT01785810|"~     RATIONALE: Successful allogeneic stem-cell transplantation is often limited by~     graft-versus-host disease (GVHD). Migration of donor cells into tissues plays a major role in~     GVHD. Drugs that block chemokine receptors such as CCR5, can potentially decrease the~     migration of donor cells into tissues. Blocking CCR5 after allogeneic stem-cell~     transplantation may therefore reduce the rates of GVHD.~      PURPOSE: This study explores the efficacy of pharmacologic inhibition of CCR5 in prevention~     of GVHDby administering maraviroc during allogeneic stem-cell transplantation with reduced~     intensity conditioning.~   "
136108|NCT01785667|"~     The objective of this study is to clarify the current diabetic status, including development~     of complications, in a nationwide cohort of type 1 diabetics, who were last examined together~     in a large study in 1995. These youngsters were originally participating in a nationwide~     study of children with type 1 diabetes in Denmark back in 1986. The investigators will try to~     establish risk factors for developing diabetic retinopathy. The investigators will have~     emphasis on retinal vessel geometry and the possibilities for early detection of reversible~     retinal changes, and prediction of other vascular complications.~   "
136109|NCT01785654|"~     Prospective, observational clinical multicentric study in ICU; during the period surrounding~     the orotracheal intubation.~   "
136110|NCT01785641|"~     To compare the efficacy of single versus combined antibiotic therapy for bacterial~     peritonitis in CAPD patients.~   "
136098|NCT01785797|"~     This is a prospective randomised-controlled multi-centre trial based in Hong Kong to~     determine whether temporary subdural drain placement after burr hole evacuation of a chronic~     subdural haematoma can reduce the risk of recurrence. Consecutive patients, 60 years old or~     above, diagnosed to have symptomatic chronic subdural haematoma and indicated for burr hole~     operative drainage will be randomly allocated into one of two groups: (1) for intra-operative~     subdural drain placement (intervention group) or (2) not for drain placement (control group).~     Using web-based software block randomisation with an allocation ratio of 1:1 will be~     conducted. Instructions to use or not to use a drain will be contained in a sealed envelopes~     labelled with sequential study numbers.~      Intra-operatively, if the surgeon-in-charge judges that after burr hole evacuation of the~     haematoma the patient's condition is unsafe for drain placement, the subject will be excluded~     from the study. Otherwise, randomisation will be performed at this juncture by the opening of~     the sealed envelop. The procedure involves placing a prefabricated silicon drain into the~     subdural space according to a standard protocol and will be removed on the second~     post-operative day at the bedside. Subjects in whom the operating surgeon judges that drain~     placement is unsafe will be excluded from the study. Drainage is undertaken passively by~     hanging the collection bag at the bedside in a dependent position. In addition to general~     demographic, clinical and radiological presentation data, potential risk factors for~     recurrence will be documented. Serial computed tomography brain scans will be arranged~     (before discharge, at four weeks and six months) and the occurence of significant subdural~     haematoma recurrence requiring repeat operative drainage at six months will be recorded.~     Other outcome measures to be determined at regular time intervals for a total follow-up~     period of six months (upon discharge, at four weeks and six months) include: functional~     performance in terms of the extended Glasgow Outcome Scale and modified Rankin Scale, added~     neurological deficit, death and other surgery-related complications. All outcomes will be~     documented by the trial investigators or by the responsible clinician. The data obtained will~     be analysed according to the principle of intention to treat.~      Hypothesis: compared to burr-hole evacuation of chronic subdural haematoma alone (control),~     the additional placement of a subdural drain after evacuation (intervention) will reduce the~     risk of recurrence requiring repeat surgery.~   "
136099|NCT01785784|"~     This was a multicenter, randomized, phase Ⅳ study, to investigate the extensive efficacy and~     safety of Recombinant Human Granulocyte/Macrophage Colony-stimulating Factor Hydro-gel for~     Topical Application (rhGM-CSF Gel) on deep 2nd burn.~      There are two parts of the phase Ⅳstudy, the first part was a multicenter, randomized,~     reference controlled study, all the subjects were randomized into two groups, test group~     (rhGM-CSF Gel) and control group (iodophor gauze), totally 358 deep 2nd burned patients were~     enrolled in first part of the study, 177 cases were enrolled in test group and 181 cases were~     enrolled in reference control group. In the test group, after the patients were enrolled in~     the group, clean the wound surface regularly and wash with normal saline, spread the test~     drug on the wound surface, bandaging with sterilized vaseline gauze, change the drug product~     every two or one day according to the effusion. In the reference control group, after the~     patients were enrolled in the group, clean the wound surface regularly and wash with normal~     saline, bandaging with iodophor gauze, change the drug product every two or one day according~     to the effusion. Whole treatment were lasted till the wound surface was healing completely,~     if it is not recovered in 4 weeks, calculate and record the healing rate. The secondary part~     of the study was a multicenter, open study, to investigate the safety of rhGM-CSF on deep 2nd~     burn patients. Totally 2329 patients were enrolled in this part of the study.~   "
136100|NCT01785771|"~     An 39-week plus extensions, open-label study to estimate the reduction in HbA1c in patients~     with initial HbA1c >10% </=12% who are treated with ITCA 650 20 mcg/day for 13 weeks followed~     by ITCA 650 60 mcg/day for 26 weeks plus optional 26-week extensions with continued treatment~     with ITCA 650 60 mcg/day~   "
136101|NCT01785758|"~     The purpose of this study is to determine whether sugammadex reverses a profound~     neuromuscular blockade induced by rocuronium in patients with end-stage renal disease just as~     effectively and safely as it does in patients with normal renal function.~   "
136102|NCT01785745|"~     It is a single-blind randomized controlled clinical trial to evaluate the effectiveness of~     neurocognitive therapeutic exercise in subjects affected by shoulder impingement syndrome in~     comparison with traditional therapeutic exercise. The traditional exercise protocol contains~     mainly strengthening exercises, stretching exercises, Codman's pendulum exercises and~     exercises against elastic band resistance. The neurocognitive exercise protocol contains ten~     exercises involving specific instruments (e.g., table inclined with a board with five~     concentric circles, sponges of various texture). Each subject, randomly assigned to either~     neurocognitive therapeutic exercise (group 1) or traditional therapeutic exercise (group 2),~     will be submitted to one-hour session for three times a week for five weeks. The outcome~     measures used will be the Quick-DASH questionnaire, the Constant-Murley shoulder outcome~     score, the ASES score, a visual analogic scale (VAS) and the assessment will be performed at~     baseline (T0), at the end of treatment protocol (T1), at 3 months (T2) and 6 months (T3) from~     the end of treatment.~   "
136103|NCT01785732|"~     Hypertension is a major risk factor for stroke and cardiovascular mortality. Catheter- based~     renal denervation causes substantial and sustained blood- pressure reduction in patients with~     resistant hypertension.~      The purpose of RENSYMPIS is to study the effects of renal denervation on:~        1. Cardiovascular function~        2. Metabolic factors~        3. Inflammatory and endocrine factors~        4. Coagulation~        5. Sleep~   "
136104|NCT01785719|"~     The purpose of this study is to investigate the effects of weight loss on ovarian morphology,~     metabolism, and body composition in overweight and obese women with polycystic ovary syndrome~     (PCOS).~   "
136105|NCT01785706|"~     The COPD Research Registry is a confidential database of individuals diagnosed with COPD or~     at risk of developing COPD. The Registry was established in 2007 by the COPD Foundation with~     the purpose of providing a mechanism for researchers to boost enrollment in clinical trials~     and other research studies. The COPD Foundation is working with National Jewish Health in~     Denver, Colorado to serve as the Registry's Data Coordinating Center and to ensure strictest~     confidentiality of participant information.~   "
136106|NCT01785693|"~     The aim of this study is to assess, in patients scheduled for femoropopliteal bypass, the~     benefit of a double peripheral nerve block (femoral + sciatic) with levobupivacaine and~     clonidine in a single dose, performed before induction of general anaesthesia, on analgesia~     postoperatively assessed by morphine consumption.~      Applied to the patient at the beginning of general anesthesia, this technique could allow one~     hand, to reduce the need for opiates, on the other hand - due to anesthetized limb~     vasodilation - to improve tissue perfusion downstream.~   "
136107|NCT01785680|"~     The long-term objective of this proposal is to develop and demonstrate an effective,~     integrated and streamlined protocol to treat moderate acute malnutrition (MAM) and~     non-complicated severe acute malnutrition (SAM) in children during humanitarian emergencies.~      Hypothesis: An integrated management protocol for MAM and SAM will achieve greater community~     coverage and a greater individual recovery rate than standard care.~   "
136112|NCT01785615|"~     Little is known regarding the association of individual components of the metabolic syndrome~     (MBS) and prothrombotic, inflammatory and preclinical cardiac structural and functional~     markers in women with this syndrome. Less is known about adequate treatment as the~     pathological mechanism of this syndrome is not well understood.~      The purpose of this study is two fold;~        1. To determine basic differences in biochemical and cardiovascular structural markers in~          women with and those without MBS and their association with the individual components of~          MBS.~        2. To determine the impact of atorvastatin to lower the risk factors of Metabolic Syndrome.~          Atorvastatin is one of the most effective drugs approved by the United States Food and~          Drug Administration (FDA) for the treatment of high cholesterol. It belongs to a class~          of drugs called statins and its role in primary prevention is still unclear. Thus this~          population seems to be an ideal group that may benefit from this intervention.~   "
136113|NCT01785602|"~     The purpose of this study is to determine whether QAW039 is safe and has beneficial effects~     in people who have moderate to severe atopic dermatitis (AD).~   "
136114|NCT01785589|"~     The new cadmium-zinc-telluride (CZT) technology is a powerful tool for cardiac nuclear~     medicine. The increased photon counting sensitivity of camera can be used to explore novel~     protocols like dual isotope (rapid stress Tl-201/rest Tc-99m protocol for use with high-speed~     SPECT MPI). The use of dual isotope imaging is very interesting because this imaging combines~     the use of thallium-201 with technetium-99m agents permitting optimal image resolution and~     simultaneous assessment of viability, all with an exam duration of approximately 20 minutes.~     However, no study compares stress thallium-201/rest technetium-99m sequential dual isotope~     high-speed myocardial perfusion imaging versus invasive coronary angiography. The~     investigators report here the first validation of high-speed protocol with dual isotope for~     myocardial perfusion imaging using invasive coronary angiography as the standard of~     reference.~   "
136115|NCT01785576|"~     The purpose of this study is to determine whether a brief couple-based supportive~     intervention effectively assists patients and their partners coping with the challenges of~     head and neck cancer.~   "
136116|NCT01785563|"~     The purpose of this study is to determine if a new type of mechanical ventilation, or~     breathing machine (called neurally adjusted ventilatory assist or NAVA), will provide~     additional support to infants who were born prematurely. Investigators are looking to~     determine if in two hours infants who weighed less than 1500 grams or 3 pounds 5 ounces, will~     demonstrate a decrease in the amount of carbon dioxide (the gas that humans exhale) dissolved~     in their blood as compared to prior to starting the study. This will be accomplished by~     enrolling infants who are stable on their current type of mechanical breathing that provides~     a constant air flow into the infant. This type of mechanical support helps keep the lungs~     inflated but does not help remove carbon dioxide. This study will change the type of~     mechanical support to a type of support called neurally adjusted ventilatory assist or NAVA.~     This type of mechanical support detects when the infant is breathing in by having electrical~     sensors on a feeding tube that is placed into the stomach through the nose or mouth. These~     electrical sensors detect when the diaphragm or the muscle that helps humans breath is trying~     to take a breath in. When the NAVA ventilator senses the attempt to breath, it provides~     additional air flow to make the effort of breathing easier. The ventilator will be attached~     to a tube or cannula that is placed into the infant's nose. After two hours of being on the~     NAVA ventilator a repeat measure of carbon dioxide in the blood will be performed by taking a~     small amount of blood from the infant's heel.~   "
136117|NCT01785550|"~     Amyotrophic Lateral Sclerosis (ALS) is a progressive fatal neurodegenerative disease~     affecting motor neurons. Early diagnosis is essential for the success of clinical trials and~     objective biomarkers are needed for monitoring disease progression. Nerve and muscle~     ultrasound may provide this information.~      This study will collect pilot data to evaluate the value of muscle and nerve ultrasound to~     identify and monitor disease progression in ALS.~   "
136118|NCT01785537|"~     The main aim of this multicentric 5-year follow-up study is to evaluate for the first time~     the long-term efficacy and safety (in terms of smoking-related serious diseases requiring~     hospitalization) of e-cigarette smoking, comparing its health effects with those of~     traditional cigarette smoking and mixed electronic and traditional cigarette smoking.~      The study will also permit to evaluate, over a 5-year follow-up, the self-reported quality of~     life, and the reported adverse events according to current and past smoking habit.~      Finally, the study will also explore the long-term adherence to e-cigarette smoking and its~     efficacy of e-cigarettes in reducing and/or quitting traditional cigarette smoking.~   "
136119|NCT01785524|"~     The hypothesis of this proposal is that in subjects with Type II diabetes mellitus (T2D) and~     peripheral arterial disease (PAD) with intermittent claudication (IC), regular consumption of~     a high nitrate supplement which raises plasma nitrite, in conjunction with 12 weeks of~     supervised exercise training at the limb ischemic threshold (SET) will produce a greater~     clinical benefit (increases in claudication onset time [COT] and peak walking time [PWT]~     relative to a group with the same exercise training but supplemented with placebo .This study~     is essentially exploratory in nature and designed to provide us with information to~     adequately develop power and execute a larger study. We have previously seen benefits from~     nitrate supplementation on function in PAD.~   "
136120|NCT01785511|"~     Endothelium derived nitric oxide (NO) regulates vascular tone and blood pressure in man. NO~     also inhibits platelet aggregation and mediates a variety of beneficial anti-inflammatory and~     repair mechanisms. NO may also be a mediator in the release of the endogenous fibrinolytic~     factor, tissue-plasminogen activating factor (t-PA) from the endothelium.1 Via these actions~     it plays a very important role in protection of the vasculature from atherothrombosis and~     clinical sequelae such as myocardial infarction and stroke.~      Visible and ultraviolet (UV) light relax vascular smooth muscles by producing NO in a~     phenomenon known as photorelaxation.2 The investigators have demonstrated significant stores~     of pre-formed, bound NO and other nitrosospecies in human skin, which are rapidly released~     upon exposure to UVA.3 The investigators have demonstrated recently that serum nitrite and~     nitroso-species are increased after standing in a UVA phototherapy cabinet and that local UVA~     exposure is associated with increased forearm arterial blood flow that is independent of skin~     temperature. The investigators have also demonstrated a fall in mean arterial blood pressure~     in subjects exposed UVA.~      Cardiovascular morbidity and the prevalence of hypertension vary with latitude. The~     investigators hypothesise that some of this geographical variation may be explained by a~     diminished sunlight/UVA exposure with attendant negative effects upon NO bio-availability.4~     To further examine the potential beneficial effects of UVA exposure we will examine the~     effects of whole-body UVA upon platelet activation and upon myocardial/coronary arterial flow~     reserve. The investigators will correlate these measures with systemic nitrate, nitrite and~     nitroso-species content in healthy volunteers.~      HYPOTHESES~        1. UVA irradiation enhances coronary flow reserve in healthy volunteers.~        2. UVA irradiation suppresses platelet activation in healthy volunteers.~        3. UVA irradiation enhances the release of endogenous fibrinolytic factors in healthy~          volunteers.~   "
136121|NCT01785498|"~     Healthy Lifestyles for Children with Complex Heart Problems is a planning and resource~     development project. The goal of the project is to develop an implementation plan that would~     enable children with complex heart problems to lead healthy, active lives within their own~     community. The primary goal of the project is to promote physical activity, because the~     physical and mental health benefits of activity are very important for these children.~     Children with complex heart problems have a higher risk for obesity, diabetes, acquired heart~     disease and mental health problems than their healthy peers. The physical health benefits of~     physical activity are well known, but physical activity is also key for children's mental~     health. Physical activity enables children to socialize with peers and create bonds and~     friendships. Physical activity participation also directly elevates mood through the release~     of brain chemicals. Children with complex heart problems are also known to experience fear~     and anxiety related to physical activity. This project will also develop strategies to~     promote healthy eating and the prevention of physical activity-related injuries to these~     children and their families. Children with complex heart problems are at higher risk of~     overweight and obesity and face unique injury risks related to pacemakers or their~     medications.~      Extensive consultations with families and caregivers have identified needed supports for~     physical activity lifestyles, mental health, healthy eating and injury prevention for these~     children. The goal of the interviews was to understand the positive and negative influences~     on physical activity and healthy lifestyles for these children. Analyses of the interview~     content was used to develop a detailed, step-by-step implementation plan to provide the~     supports necessary for children with complex heart problems to lead active, healthy lives in~     their own community, with their family and friends. The implementation plan specifies changes~     to family education and counselling resources, clinical care routines, and communication~     among professionals and families.~      The clinical trial will evaluate the impact of implementing the family supports and changes~     to practice previously developed. Surveys will be completed by families attending the cardiac~     clinic before and after the changes to practice and additional resources are made available.~     Interviews will be utilized to gather additional feedback from professionals and families~     that receive counselling utilizing the supplementary materials.~   "
136122|NCT01785485|"~     This study is Phase II of a project by the University of Arizona Center for Integrative~     Medicine (AzCIM). Collaborating with AzCIM is the Health Outcomes and Pharmacoeconomics~     (HOPE) Center and the RAND Corporation, Inc. Phase II is a prospective evaluation of the~     clinical and cost effectiveness (outcomes) of an integrative medicine professional practice~     model for adult primary care delivery (the University of Arizona Integrative Health Center -~     UAIHC in Phoenix, AZ). Data will be gathered from eligible and consenting members of UAIHC.~     In addition, a fidelity evaluation will assess whether the practice model was implemented as~     planned.~      The specific aims are to: 1) Recruit, consent, and enroll a sample of eligible patient and~     staff participants from UAIHC; 2) Conduct outcome evaluation of UAIHC care using patient data~     from medical records abstractions, self-report assessments, clinic administrative and service~     utilization/encounter data, and health insurance claims data; and, 3) Conduct fidelity~     evaluation of the implementation of the UAIHC model as described in its business plan using~     patient- and staff-reported fidelity assessments, random chart audits, and abstracted clinic~     administrative data.~      Participants. 1) Participants from the clinic patient population for whom clinical and cost~     outcomes will be tracked (n=500); 2) Clinic patients from whom fidelity data will be~     collected (n=180); and, 3) Clinic personnel from whom fidelity data will also be collected~     (n=14).~      Data Collection. For outcomes evaluation, data will be collected at baseline (initial clinic~     visit), and at 3-, 6-, and 12-month follow up periods. Sources include clinical symptoms and~     biomarkers from medical records abstractions; patient reported outcomes and satisfaction~     questionnaires; clinic service encounter logs; and, cost data from health insurance claims~     information and clinic financial data. For fidelity evaluation, data will be collected~     monthly for 6 months after study start, quarterly for the next 6 months, and semi-annually~     from then on. Patient data for fidelity will be gathered on a single randomized day of the~     week using a self-administered patient feedback questionnaire. For personnel, fidelity data~     will be collected at the same intervals using a self-administered provider perceptions~     questionnaire of inter-professional team and integrative medical care. Data from audits of~     randomly selected patient charts and administrative records will also be used.~   "
136123|NCT01785472|"~     This study will assess the efficacy and safety of multiple doses of LCZ696 compared to~     olmesartan in Asian patients with essential hypertension~   "
136124|NCT01785459|"~     Headache is a common chief complaint of patients presenting to the emergency department (ED),~     accounting for approximately 3 million ED visits per year. Headache treatment is often a~     source of frustration for both patients and providers. By the time patients with benign~     headaches arrive in the emergency department, they have often failed non-invasive therapeutic~     attempts and providers are often left with few therapeutic options. Treatment of benign~     headache varies between providers, often including systemic medications with a multitude of~     possible side effects. In recent years, there has been preliminary investigation into~     anesthetic injections for the undifferentiated headache patient presenting to the emergency~     department. It has been proposed that these patients presenting with benign headache might~     benefit from this novel treatment.~      Patients that present to the Emergency Department with a diagnosis of benign or primary~     headache with serious or life-threatening causes of headache will be offered enrollment into~     the study.~      Following consent, subjects will receive either 0.5% bupivacaine injected bilaterally in the~     paraspinal musculature of the cervical spine or the standard treatment with intravenous~     Prochlorperazine. The subjects will complete a validated pain scale before, and 20 minutes~     after injection. At twenty minutes post-injection, the subject will be reevaluated for~     symptoms. The subject will then be eligible for discharge or standard treatment at the~     discretion of the treating physician.~      Subjects will be followed for 72 hours after enrollment for headache recurrence. Subjects~     will be monitored for immediate and post-discharge complications.~   "
136125|NCT01785446|"~     The purpose of this study is to:~        -  determine the effect of dexmedetomidine on cisatracurium infusion requirements and~          sufentanil consumption.~        -  analyze the cisatracurium infusion requirements and sufentanil consumption in different~          age groups.~   "
136126|NCT01785433|"~     The primary objective of this study is to assess and compare the pharmacokinetics (PK) of~     Tiotropium delivered via Breath Actuated Inhaler (BAI) (4.5 mcg/day or 9.0 mcg/day),~     SPIRIVA®, HandiHaler®, (18 mcg/day) and Respimat® Soft Mist™ Inhaler (SMI) (5.0 mcg/day)~     following repeat dosing for 7 days in subjects with COPD.~   "
136127|NCT01785420|"~     Background Information and Rationale:~      Trastuzumab is a humanized monoclonal antibody that acts extracellularly on the erbB-2~     receptor.Trastuzumab is a recombinant humanized IgG1 monoclonal antibody against the human~     epidermal growth factor receptor 2 (HER2/erbB-2),which has shown in both in vitro assays and~     in animals, to inhibit the proliferation of human tumour cells that overexpress erbB-2.~     Additionally, trastuzumab is a potent mediator of antibody-dependent cell-mediated~     cytotoxicity (ADCC). In vitro, trastuzumab-mediated ADCC has been shown to be preferentially~     exerted on erbB-2 overexpressing cancer cells compared with cancer cells that do not~     overexpress erbB-2. Trastuzumab has emerged as a widely accepted standard of care for~     erbB-2-positive disease. (Metastatic/ adjuvant/neoadjuvant.~      Our current hypothesis suggests that the cells which are disseminated at the time of surgery~     will encounter an inhospitable environment which will be anti-HER in nature. Therefore~     combining the above mentioned streams of thought, we would like to assess the effect of a~     short pre-operative course of Trastuzumab on breast cancer relapse. The study is proposed in~     HER2 positive patients with operable breast cancer.~      Objectives :~      Primary:~      The primary objective of the study is to see the effect of short duration of peri-operative~     Trastuzumab on disease-free survival in comparison in all patients~      Secondary:~      The safety of the pre-operative therapies including the early post operative morbidity~        1. Overall survival (OS) in all patients and in pathologically node positive patients.~        2. The level of circulating tumor cells (CTCs) in the peripheral blood assessed before~          starting pre-operative therapy and at the same time point in the control arm, level of~          CTCs 10 minutes prior to start of surgery, during surgery and 10 days after surgery on~          40 consecutive consenting patients (20 in each arm). The levels of circulating chromatin~          will also be estimated at the same time points as CTC for these 40 patients.~        3. Evaluation of the paraffin blocks for pTEN loss6-8 and p95ErbB2 truncated form of HER2~          on 100 consecutive consenting patients (50 in each arm).9-11~      Study Design :~      This is phase 3, randomized Double blinded parallel group study of Trastuzumab in pre~     operative setting in operable breast cancer patients.~      Approximately 1000 patients with Women with HER2neu positive, T1/T2/T3 and N0/N1. clinical T4~     and/or N2 disease who are considered operable by the treating surgeon with histopathological~     diagnosis on core biopsies, will be included in the study. Patients with T4 or N2 (locally~     advanced and large operable for neo-adjuvant chemotherapy) will not be included. All node~     positive patients will receive single injection of Depot Inj. Progesterone 500 mg deep IM 4~     -14 days prior to surgery~      Patients will be stratified, before randomization for Tumor size, menopausal status, and~     affordability for Trastuzumab and centre of the study. These patients will then be randomized~     1:1 to receive the following~      Intervention arm: .A single dose of Trastuzumab (Herceptin, Hoffman La Roche) at 8 mg/Kg as a~     90 minute intravenous infusion in 250 ml of normal saline, in the window period of 10-15 4 to~     14 days (both days inclusive) prior to the planned date of surgery.~      Control arm: A 90 minute intravenous infusion of saline as placebo~      All patients will thereafter receive standard post-operative adjuvant therapy as per local~     institutional practice including hormonal therapy, chemotherapy and radiation therapy.~   "
136128|NCT01785407|"~     Oral iron supplementation (OIS) is a widely-used strategy to treat iron deficiency anemia.~     However, absorption of OIS is often low and response is variable. To overcome this, large~     doses are given but this may reduce compliance due to gastric irritation. Thus, OIS doses~     should be low, while maximizing absorption. The prevailing serum hepcidin concentration~     (SHep) is the major determinant of iron absorption and erythrocyte iron utilization. Based on~     limited data in humans, SHep can be increased by a single OIS dose but the duration of the~     increase is uncertain: it may be in the range of 24 to 96 hr. Also, there are few data on how~     the increase in SHep determines the absorption of further doses of oral iron. Is there a~     threshold SHep at which subsequent iron absorption is sharply reduced? Better understanding~     of this relationship would be valuable to design more effective and safer OIS regimens.~      Objectives: 1) Determine the duration and magnitude of the Fe induced Hepcidin rise form a~     single iron dose while determining its bioavailability and 2) Compare the bioavailability of~     a single dose to iron supplements consumed one after the other (two dosages).~   "
136129|NCT01785394|"~     The purpose of this study is to determine whether exhaled breath temperature, a surrogate~     marker of airway inflammation, rises during the pollen season in sensitized subjects with~     allergic rhinoconjucnctivitis with or without mild asthma. Sublingual Immunotherapy with~     respective allergens suppresses the seasonal increase of EBT. During the second year (2013)~     of the trial all patients will be treated with 5 grass allergen extract: carry over~     differences between the active and placebo arms from the previous year (2012) will be looked~     for.~   "
146194|NCT01653496|"~     The purpose of this study is to prospectively evaluate the overall compliance to the enhanced~     recovery after surgery (ERAS) program in patients undergoing gastric cancer surgery.~   "
136130|NCT01785381|"~     Introduction: Hip fracture due to osteoporosis is associated with an extremely high mortality~     morbidity and loss of quality of life. The risk of future fracture after a first hip fracture~     is increased. Several studies reported that patients who suffered from a fracture are not~     optimally treated and do not receive osteoporosis treatment after the first fracture episode.~      Aim: To evaluate whether a coordinator increases the optimal management of osteoporotic~     fracture patients and hip fracture patients.~   "
136131|NCT01785368|"~     The main objective of this study is to evaluate the impact of the implementation of referral~     guidelines for imaging exams requested by the emergency department on exam relevance. The~     latter is assessed via the rate of suspected diagnoses that are confirmed by the requested~     exam.~   "
136132|NCT01785355|"~     Several studies revealed a direct relationship between the severity of periodontal~     inflammation and CRP (NHANES III, Dumitriu HT et al, 1998). In patients without any other~     source of inflammation but PDD, proper dental treatment of the disease decreased CRP to~     normal levels (Dumitriu H.T. et al., 1998; D'Aiuto F. et al, 2004; Borawski J. et al., 2007)~     Moreover, a direct link between high levels of CRP and atherosclerotic complications has been~     found in studies conducted both in general population (Ridker PM, et al., 1998; Koenig W, et~     al., 1999) and in HD subjects (Westhuyzen J, et al., 2000; Iseki K., et al., 1999; Zimmermann~     J, et al. 1998).~   "
136133|NCT01785342|"~     The goal is to improve the efficiency of the diagnostic follow-up of patients with~     indeterminate pulmonary nodules by determining whether biomarkers for lung cancer diagnosis~     that are measured in minimally invasive biospecimens are able to distinguish malignant from~     benign pulmonary nodules that are incidentally detected in high-risk smokers.~   "
136134|NCT01785329|"~     Primary Objective:~      To assess the relative bioavailability of a single subcutaneous dose of alirocumab SAR236553~     (REGN727) administered at 3 different injection sites in healthy subjects.~      Secondary Objectives:~        -  To assess the pharmacodynamic effect of a single subcutaneous dose of alirocumab~          SAR236553 (REGN727) on serum low-density lipoprotein cholesterol and other lipids and~          apolipoproteins.~        -  To assess the safety of a single subcutaneous dose of alirocumab SAR236553 (REGN727).~        -  To assess the immunogenicity of a single subcutaneous dose of alirocumab SAR236553~          (REGN727).~   "
136135|NCT01785316|"~     A randomized controlled, open-label, multi-centre study evaluating if Isolated Hepatic~     Perfusion (IHP) increases Overall Survival compared with Best Alternative Care (BAC) in~     patients with isolated liver metastases from uveal melanoma.~   "
136136|NCT01785303|"~     The overall goal of this project is to determine the efficacy of a multidisciplinary~     treatment model for patients with Obstructive Sleep Apnea (OSA) and comorbid Insomnia.~      Specific Aim 1: To determine the efficacy of a treatment model combining Cognitive Behavioral~     Therapy (CBT) and Continued Positive Airway Pressure(CPAP) for individuals with OSA and~     comorbid insomnia.~      Specific Aim 2: To determine if there are relative benefits in the sequence of treatment~     initiation.~      Specific Aim 3: To examine the mechanisms between insomnia symptoms and CPAP adherence.~   "
136137|NCT01785290|"~     The aim of this study is to determine the effects of a low dosage of prophylactic haloperidol~     in patients with a high risk to develop delirium, defined by an expected ICU length of stay~     of >1 day. The investigators hypothesized that haloperidol prophylaxis in patients with a~     high risk for delirium reduces 28-day mortality, delirium and delirium related outcome.~      Two different dosages of haloperidol are used in this study to compare with placebo. A dosage~     of 1mg, or 2mg or placebo three times a day in a double-blinded fashion resulting in a~     three-armed multicentre randomized double-blinded placebo-controlled trial. To relate the~     potential beneficial effects of haloperidol to the a priori risk to develop delirium, the~     PREDELIRIC-model (delirium prediction model for ICU patients) will be used. This will enable~     the investigators to determine the preventive efficacy of haloperidol in patient groups based~     on their risk to develop delirium.~   "
136138|NCT01785277|"~     The propose of the study is to validate in Mexico a spanish translation of the Spinal Cord~     Independence Measure (SCIM) Version III, in patients with spinal cord injury (SCI).~      Internal consistency, reproducibility and reliability will be addressed scoring the results~     of the translated version at two time frames and also of the same patients by different~     examiners (physicians, nurses and technicians).~   "
136139|NCT01785264|"~     To compare the end-results of three different methods of treatment of acute achilles tendon~     ruptures, it is necessary to establish identical rehabilitation protocols. Traditionally,~     early mobilization has been reserved for patients treated surgically and this may have~     unintentionally skewed treatment results. The investigators have therefore designed a~     prospective randomized trial performed as collaboration between Akershus University Hospital~     (Ahus), Oslo University Hospital (The Emergency Department), Østfold Hospital (Fredrikstad)~     and Drammen Hospital. The four institutions were chosen because of their geographical~     proximity and because they jointly have a substantial catchment area. Treatment is divided~     into three arms, and patients between 18 and 60 years of age sustaining first time achilles~     tendon ruptures will be invited to participate.~   "
136140|NCT01785251|"~     Patients post total hip arthroplasty (THA) remain at high risk of developing Deep Vein~     Thrombosis (DVT) during the recovery period following surgery despite the availability of~     effective pharmacological and mechanical prophylactic methods. The use of calf muscle~     neuromuscular electrical stimulation (NMES) during the hospitalised recovery period on this~     patient group may be effective at preventing DVT. However, the haemodynamic effectiveness and~     comfort characteristics of NMES in post-THA patients immediately following surgery have yet~     to be established.~      The main objectives are:~        1. To establish if patients in the early post-operative period have tolerance for NMES.~        2. To determine if applying NMES to patients immediately post-THA increases venous outflow~          from the lower limb over resting conditions.~   "
136141|NCT01785238|"~     The aim of this study is to evaluate the signs of nephronic reduction in preterm infants who~     have presented neonatal acute renal failure. The investigators hypothesize that signs of~     nephronic reduction would appear earlier in former preterm with neonatal acute renal failure~     than in control preterm infants.~   "
136915|NCT01775124|"~     The study evaluated the efficacy and safety of two different dosing regimens of ranibizumab~     (either monthly injections or injections as-needed based on the stability of a patient's~     vision) in Chinese patients with wet age-related macular degeneration (AMD) . This study was~     to provide long-term safety data in the treatment of Chinese patients with wet AMD.~   "
136142|NCT01785225|"~     Thousands of vein punctures are done every day at hospitals worldwide. Vein puncture are~     performed in connection with blood sampling, peripheral intravenous catheter (PIV) placement~     or blood donation. The predominantly used venous for blood withdraw are in the cubital region~     because in this area venous are most superficial placed and most often visible for the human~     eye. However, when using the usual blind landmark and palpation method in this region, it~     often proves exceedingly difficult or even impossible to obtain peripheral venous access on~     patients who are obese, chronically ill, hypovolemic or intravenous drug users. Various~     studies have shown that the success rate for establishing a vascular access with ultrasound~     compared to blind landmark technique is higher in patients with difficult access. When~     ultrasound is used to establish intravascular access, the prerequisite sterile puncture area~     can be challenging to meet due to ultrasound gel on the area and the fact that the ultrasound~     transducer cannot be wiped clean with alcohol after being in contact with a patient's skin or~     blood. A strict sterile procedure is important to reduce complications related to~     infection.The traditional way of coping with this is by covering the transducer and the wire~     in a long sterile sheet and using sterile gel. The sheet must be tight with rubber band~     around the transducer and pulled tightly around the transducer foot to prevent artefacts from~     appearing on the screen. This is an expensive and time consuming method, and it still leaves~     the problem with gel in the puncture area.~      The investigators have developed a method by where all these problems are solved by using, a~     slightly modified, commercial drape in combination with the Dynamic Needle Tip Positioning~     technique~      The investigators hypothesize that it is possible to perform ultrasound-guided venous~     puncture with a sterile and dry puncture area and that puncture can be performed proximal and~     distal to the traditional puncture side.~      It is a procedure presenting study that serves to demonstrate the feasibility of the method~     in ten healthy volunteers. The study will take place at Aarhus University Hospital, Skejby.~   "
136143|NCT01785212|"~     The CUSA (cavitron ultrasound surgical aspirator) is the method of choice for hepatic~     resection in our center. Recently a stapler-hepatectomy methods has been developed and~     approved for liver surgery using Covidien Endo-Gia stapler. The potential benefit of this~     method is a potential shorter transection time compared to the CUSA technique. Thus the~     investigators will perform a randomized controlled trial including 20 patients in the~     stapler-group and 20 patients in the CUSA control group. Primary endpoint will be transection~     speed. Secondary endpoints will be peri-operative (d-1, d0, d1, d3) cytokines concentration,~     T cell subsets, blood loss, morbidity, and a cost analysis.~   "
136144|NCT01785199|"~     Sleep is known to be a dynamic state of consciousness that is characterized by rapid~     fluctuations in autonomic activity as well as changes in body postures. Body postures during~     sleep influence the severity of sleep-disordered breathing because a supine position is~     associated with an increase in upper airway collapsibility and thus an increase in frequency~     and duration of snoring and apnea. Use of an adjustable bed to elevate patients' head might~     improve those conditions. The purpose of the present study is to determine whether use of an~     automatic adjustable bed is associated with reducing sleep-disordered breathing in patients~     with suspected obstructive sleep apnea (OSA) due to upper airway problems.~   "
136145|NCT01785186|"~     This study is a multiple-arm, multiple-stage (MAMS), phase 2, open label, randomized,~     controlled clinical trial that will compare the efficacy and safety of four experimental four~     drug regimens with a standard control regimen in patients with smear positive, pulmonary~     tuberculosis (TB). Patients will be randomly allocated to the control or one of the four~     experimental regimens in the ratio 2:1:1:1:1. Experimental regimens will be given for 12~     weeks. Thereafter, participants in the experimental arms will receive continuation phase~     treatment for 14 weeks containing standard-dose rifampicin and isoniazid. All participants~     will receive 25 mg of vitamin B6 (pyridoxine) with every dose of INH to prevent INH‐related~     neuropathy. Interim analyses will be conducted during the trial for efficacy, with the aim of~     identifying experimental arms that perform below a pre‐specified efficacy threshold; these~     arms will then be stopped from further recruitment.~      Following the first scheduled interim analysis on March 3rd, the Trial Steering Committee~     (TSC) followed a recommendation of the independent data monitoring committee (IDMC) and has~     stopped the enrolment into two of the arms in the MAMS-TB trial: HRZQ and HR20ZQ, based on~     these arms not meeting the pre-specified gain in efficacy over control. Importantly, there~     was no safety concern that prompted stopping recruitment to these arms. They recommended that~     recruitment to arm 2 (HRZQ) and 3 (HR20ZQ) be terminated as there was insufficient evidence~     that these regimens could shorten treatment. Importantly, there was no evidence that either~     arm was inferior to standard treatment (the control arm) with regards to efficacy. There was,~     however, sufficient evidence that the other intervention arms HR35ZE and HR20ZM could shorten~     treatment to continue enrolling patients.~   "
136146|NCT01785173|"~     Unsedated transnasal esophago-gastro-duodenoscopy (UT-EGD) has gained wide popularity and is~     one of the most frequently performed diagnostic procedures in Japan and Europe. The technique~     of using a cotton pledget soaked with lignocaine and decongestant is quite effective but does~     cause some discomfort during application of anesthetic agent to the nasal cavity. Hence, an~     effective method to deliver anesthetic agent, using a minimal dose of drugs, and at the same~     time maintain a good ﬁeld of vision during endoscopy are all very important.~      Using a cotton-tippled applicator to deliver a soaked gauze strip may cause kinking of it~     around the nasal vestibule or just in the anterior end of a turbinate. Endoscopic guidance to~     deliver a gauze strip can confirm delivering it to at least the posterior end of a turbinate.~     We hypothesize that a simple endoscopic-guided gauze pledgetting method is more tolerable~     than the blind cotton-tippled applicator method to deliver a gauze strip for anesthetizing~     the nasal cavity.~   "
136147|NCT01785160|"~     The primary objective of this trial is to investigate effect of faldaprevir on steady state~     pharmacokinetics of raltegravir.~      The assessment of safety and tolerability will be an additional objective of this trial.~   "
136148|NCT01785147|"~     Clinical study which aim is to assess in heavy smokers willing to quit smoking the efficacy~     and the safety profile of BP1.4979 for smoking cessation on the total abstinence measured by~     subject diary and confirmed by exhaled CO (abstinent < 10 ppm).~   "
136149|NCT01785134|"~     Obese patients have an increased risk for developing severe metabolic disorders. This risk~     can only partly be reduced by weight reduction. The investigators have in a pilot study~     investigated if removal of abdominal fat (visceral) in addition to weight loss has additional~     beneficial effects on the metabolic profile and weight loss. This study aims to further~     investigate if removal of abdominal fat (major omentum) leads to beneficial metabolic~     effects.~   "
136177|NCT01784757|"~     A study to investigate which of two different tablet formulations of ODM-201 is best suited~     for use in the further development of the compound in the treatment of metastatic~     chemotherapy-naive castration-resistant prostate cancer. Patients successfully completing the~     bioavailability study will be able to receive further treatment with the current capsule~     formulation of ODM-201 until progression of their disease with the safety and tolerability of~     ODM-201 being assessed throughout.~   "
136150|NCT01785121|"~     The study objectives are to determine the effectiveness of structured access to a Wii game~     computer compared to motivational support only in heart failure patients on exercise capacity~     and daily activity. Secondly, to determine the effectiveness of structured access to a Wii~     game computer compared to motivational support only in heart failure patients on the combined~     endpoint of death, readmission and quality of life.~      The following research questions will be addressed:~        -  What is the effectiveness of structured introduction and access to a Wii game computer~          in patients with heart failure to improve their exercise capacity compared to patients~          with heart failure in a control group who only receive motivational support?~        -  What is the effectiveness of structured introduction and access to a Wii game computer~          in patients with heart failure compared to patients with heart failure in a control~          group who only receive motivational support to increase their daily physical activity,~          decrease health care use and improve quality of life?~        -  What are experiences of heart failure patients and how is their exercise motivation when~          they are introduced and instructed to play with a Wii game computer?~   "
136151|NCT01785108|"~     The objectives of this study is to~        -  evaluate the safety and influence of treatment with GAD-Alum (Diamyd) combined with~          Vitamin D and Ibuprofen on preservation of residual insulin secretion in recently~          diagnosed Type 1 Diabetes~        -  evaluate how the above mentioned treatments influence the immune system of the subjects~          and interact with any viral infections~        -  evaluate the safety and influence of treatment with double dose of GAD-Alum (Diamyd)~          plus Vitamin D on the immune system, viral infections, and on preservation of residual~          insulin secretion in recently diagnosed Type 1 Diabetes~   "
136152|NCT01785095|"~     The purpose of the study is to evaluate immunogenic potential of FSH-IBSA in healthy~     volunteers undergoing controlled ovarian hyperstimulation (COH) in an oocyte donation~     program.~   "
136153|NCT01785082|"~     The purpose of this study is to investigate safety and efficacy of intravenously injected~     0.4% 13-C-Methacetin solution for the determination of liver function with the LiMAx-test on~     patients with partial liver resection. The LiMAx-test is compared with an untreated control~     group and post-surgical management of both groups is investigated.~   "
136154|NCT01785056|"~     The purpose of this research is to study the effects of Privigen (intravenous immunoglobulin)~     on the skin in patients with scleroderma. Approximately 24 subjects will take part in this~     investigator-initiated study at Georgetown University Hospital and Johns Hopkins Hospital.~     This study will last for one year (12 months). This research is being done because systemic~     sclerosis can cause severe, progressive organ involvement. The investigators hope this study~     treatment will improve the outcomes in this disease, including skin, muscle, joint,~     gastrointestinal, and lung involvement.~   "
136155|NCT01785043|"~     Differences in endothelial function amongst Sitagliptin and Liraglutide Users. A randomized,~     open-label, parallel-group and active controlled trial~   "
136156|NCT01785030|"~     Nitrous oxide (N2O) is a gas that is normally used to take away pain and anxiety during~     painful medical procedures. However, one of its effects is to also make veins appear larger~     and more visible. This is useful when there is a patient who needs to have an intravenous~     (IV) needle put in their skin to give them medicine or ﬂuids, but may have veins that are~     very hard to see or feel. The mechanism of this observed effect is not entirely clear. The~     purpose of this study is to use an ultrasound to directly measure whether there is an actual~     change size of veins or change in blood flow in healthy adult volunteers when you give them~     50% nitrous oxide, and see whether or not this change in size, or change in flow, is what~     causes the changes in visibility or palpability of the vein.~   "
136157|NCT01785017|"~     A Standardized Clinical Assessment Management Plan (SCAMP) has been developed and implemented~     at Boston Children Hospital to decrease variations in clinical practice in critical asthma~     therapies for children. The primary aim is to determine whether a Critical Asthma SCAMP can~     improve clinical outcome.~   "
136158|NCT01785004|"~     The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a randomized clinical trial in~     20,000 U.S. men and women investigating whether taking daily dietary supplements of vitamin~     D3 (2000 IU) or omega-3 fatty acids (1 gram of omega-3 fatty acids) reduces the risk of~     developing cancer, heart disease, and stroke in people who do not have a prior history of~     these illnesses. This ancillary study (VITAL Adiposity) is being conducted among participants~     in VITAL and will examine the effect of vitamin D or fish oil on changes in body composition~     and adiposity (baseline compared to 2 year, as measured by anthropometric indices, total and~     regional body fat and adipokines) and assess whether changes in cardiovascular risk factors~     (lipids, glucose tolerance, blood pressure) are mediated by these parameters. How achieved~     25(OH)D levels are affected by body composition and body mass will also be assessed.~   "
136159|NCT01784991|"~     This is a study about the efficiency and safety of a 1mg+1mg hydromorphone pain management~     protocol for the treatment of moderate to sever pain in the Emergency Department. Appropriate~     patients 60 years and older who present with a condition that causes moderate to severe pain,~     according to the attending physician's judgment, in which the physician would order the use~     of parenteral analgesia will be enrolled in one of two study arms, 1+1 versus usual care~     group. 1+1 patients will receive 1mg hydromorphone followed by another 1mg after 15 minutes~     if pain persists. Usual care group patients will have pain treated per the discretion of the~     attending physician. Respiratory status, vital signs, and pain scores will be monitor to~     assess the efficiency of pain control as well as the safety of pain medicine administration~     in terms of respiratory depression.~   "
136160|NCT01784978|"~     The objective of this study is to assess the progression-free survival, of patients who~     receive rotations of sunitinib and everolimus versus patients who receive sunitinib as a~     first line treatment followed by everolimus when progression occurs.~   "
136190|NCT01784588|"~     The purpose of this research study is to compare the treatment device (Solyx) to a different~     mesh sling or control device (Obtryx II) for the treatment of symptoms for SUI. Safety~     information and patient outcomes will be collected for three (3) years and evaluated.~   "
136348|NCT01782534|"~     The relevant predictive hospital risk factors for 5-year mortality of patients with aortic~     dissection is untill unlear. The aim of this study is to collect the clinical data of 111~     hospitalized patients admitted to hospital from Aug. 2001 to Aug. 2007, and statistically~     analyze the hospital risk factors related to 5-year mortality by univariate and multivariate~     binary logistic regression.~   "
136161|NCT01784965|"~     The goal of this study is to evaluate the hypothesis that the addition of liraglutide, a~     long-acting glucagon-like peptide 1 (GLP-1) analogue, to a calorie-restricted diet will lead~     to greater weight loss than will a calorie-restricted diet alone in subjects who are older~     (50 to 60 years of age), overweight/obese, and prediabetic. These individuals have been~     selected for study because they are at greatly increased risk to develop type 2 diabetes~     (2DM) and cardiovascular disease (CVD), and it is hypothesized that the addition of~     liraglutide to a calorie-restricted diet will significantly decrease risk of these adverse~     outcomes.~      There is considerable evidence that GLP-I compounds, including liraglutide, improve glycemic~     control in patients with manifest 2DM. However, there is relatively little information as to~     the potential utility of these compounds in nondiabetic individual at greatly increased risk~     of 2DM and CVD. This research proposal is aimed at providing some of this information by~     quantifying the effects of liraglutide, a long-acting GLP-1 analogue, on weight loss, insulin~     secretion, insulin action, and multiple CVD risk factors in a very high risk group—older,~     overweight/obese, prediabetic individuals. Furthermore, by using specific methods, not~     surrogate estimates, and avoiding the confounding effects of glucotoxicity, it will be~     possible to gain new insights into the effects of GLP-1 on insulin secretion and insulin~     action.~   "
136162|NCT01784952|"~     We examined whether a substitution of whole grains and legumes for refined rice in a high~     carbohydrate diet (about 65% of energy derived from carbohydrate) may modify the effect of~     this variant on changes in apolipoprotein A-V (apoA-V) and triglyceride concentrations.~   "
136163|NCT01784939|"~     HFE(High iron FE)-related hereditary hemochromatosis has a highly variable penetrance. No~     phenotypic or genetic markers can predict the disease. The Iron Reabsorption Index (IRI),~     recently described by our group, correspond to the daily reabsorbed iron for a subject whose~     iron stock is stable and less than 50 µg / L.~      The IRI is constant over time, reflecting the importance of the underlying functional~     deficit.~      Hepcidin / ferritin (H / F) ratio may be an independent and constant over time marker of~     disease stage.No data are available on the validated values of this ratio.~      The goal of this project is to determine the intra-individual variations of the H / F ratio~     over time during maintenance therapy and to assess the correlation with the IRI.~   "
136164|NCT01784926|"~     In this prospective, randomized study The investigators will include 80 patients with late~     intraocular lens (IOL) dislocation in the capsular complex, after cataract surgery. To obtain~     normal visual function, these patients needs surgery. Today, there are two different methods~     used for this condition; scleral suturing of the capsular complex or exchange of IOL to an~     iris-fixated IOL (Verisyse). In this study the investigators will look for advantages and~     dis-advantages for these two methods.~   "
136165|NCT01784913|"~     In this study, up to 21 patients with metastatic prostate cancer will receive UV1 (a~     therapeutic synthetic peptide vaccine) at different dose levels. The safety and tolerability~     of UV1 as well as immunological response will be assessed. The purpose of this study is to~     select a biological dose of peptides for further clinical trials.~      Main treatment period is completed and reported. Follow-up ongoing.~   "
136166|NCT01784900|"~     Treatment by association of complete surgical excision of the lesions and intraperitoneal~     immunotherapy using Catumaxomab for patients with gastric peritoneal carcinomatosis~   "
136167|NCT01784887|"~     Utilizing wound healing trajectory analysis, patient-reported pain and QOL assessment,~     quantitative bacteriology, and inflammatory infiltrate quantification, an improvement in~     wound healing will be observed on a cellular, histomorphological and clinical level in the~     presence of a bioelectric dressing applied in conjunction with SOC.~   "
136168|NCT01784874|"~     The aim of this study is to generate data on immunogenicity and safety of Purified Vero~     Rabies Vaccine - Serum Free (VRVg) in comparison with Imovax® Rabies in order to support the~     registration of VRVg in the USA.~      Primary Objectives:~        -  To demonstrate that VRVg is non inferior to Imovax® Rabies in terms of proportion of~          subjects achieving an rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 IU/mL at Day~          42.~        -  To demonstrate that the observed proportion of subjects achieving an RVNA titer ≥ 0.5~          IU/mL at Day 42 is at least 99%, with a 95% lower confidence limit of at least 97%.~      Secondary Objectives:~        -  To assess the clinical safety of VRVg each vaccine after each vaccine injection when~          administered in a pre-exposure schedule.~        -  To describe the immune response induced by each vaccine 21 days after two vaccinations~          (Day 28) in a randomized subset of subjects and 14 days after the last vaccination of~          the primary vaccination series.~        -  To describe antibody persistence at 6 and 12 months after the first vaccination in all~          subjects, and at 18 and 24 months in a subset of subjects.~   "
136169|NCT01784861|"~     This study is to evaluate the combination of an investigational drug X-82 with everolimus in~     the treatment of pancreatic neuroendocrine tumors.~   "
136170|NCT01784848|"~     Phase 3, unicentric, randomized clinical trial, with allocation concealment and~     intention-to-treat analysis to evaluate the efficacy of videolaparoscopic Roux-en-Y~     Gastroplasty to decrease the prescription of antihypertensive drugs maintaining normal levels~     of blood pressure, decrease systemic arterial blood pressure and other risk factors for~     cardiovascular events compared to clinical treatments of patients with arterial hypertension.~   "
136171|NCT01784835|"~     The application of osteopathic manipulative treatment (OMT) in preterm infants has been~     demonstrated to be effective in reducing length of stay (LOS). The scope of the present study~     is to investigate the association between earlier exposure to OMT and reduction of LOS in~     premature infants~   "
136172|NCT01784822|"~     The objective this study is to collect post-market data on the performance of the Zenapro™~     Hybrid Hernia Repair Device when used to reinforce or bridge the abdominal wall for the~     repair of ventral hernias.~   "
136173|NCT01784809|"~     The proposed study addresses a significant public health threat of Human immunodeficiency~     virus (HIV) and sexually transmitted infections (STIs) among drug involved women on~     probation, parole or other community supervision. This randomized controlled trial aims to~     test the efficacy of a multimedia version of a 4-session, gender-specific, integrated drug~     use and HIV/STI prevention intervention (Multimedia Women On the Road To Health (WORTH)) in~     increasing condom use and decreasing the incidence of sexually transmitted infections (STIs)~     among 420 drug-involved, female offenders in a large community court setting in New York~     City, compared to a non-media version of the same intervention (Traditional WORTH) and to a~     4-session Wellness Promotion condition.~   "
136178|NCT01784744|"~     The febrile hypothesis of Autism Spectrum Disorder (ASD) stems from the observation that~     clinical symptoms improve during fever. This fever induced amelioration of symptoms could be~     due to one of three possible causes, (1) the direct effect of temperature; (2) a resulting~     change in the immune inflammatory system function associated with the infection or fever;~     and/or (3) and increase in the functionality of a previously dysfunctional Locus~     Coeruleus-Noradrenerigic (LC-NA) system. Little has been done to explore the potential direct~     effect an increased body temperature may have on autism symptomology. Parental reports have~     demonstrated that during febrile episodes children with ASD have improved social cognition~     and language skills, and decreased disruptive behaviors. In order to further explore the~     direct temperature effect, further investigation is needed, which the investigators propose~     below. The investigators propose to complete a one year double blind crossover study with 15~     children with ASD between the ages of 5 and 17 years old. Five children with ASD will~     complete a control protocol prior to beginning the full protocol with 10 additional ASD~     children. This will allow for any needed amendment of protocol parameters prior to completion~     of the full protocol.~   "
136179|NCT01784731|"~     Currently, office visits at general practitioners is free of charge for patients. However,~     public commissions and the Danish Economic Council have suggested to implement user charges~     for services that currently is free of charge. The aim of this study is to examine the~     consequences of introducing user charges for general practitioner services. Data for the~     project will be collected from patients who have an appointment with a general practitioner.~     Patients will be asked whether they are willing to pay a specified amount for the~     consultation that they have scheduled. After the consultation, the GP register diagnoses.~   "
136180|NCT01784718|"~     This is a single patient compassionate use protocol to determine whether Buphenyl~     (4-phenylbutyrate) will improve the poor bile flow associated with Byler Disease.~   "
136181|NCT01784705|"~     Bright light therapy (BLT) has been found to be effective in treatment of seasonal affective~     disorder (SAD). The mechanism of action of conventional BLT in the treatment of SAD is under~     debate. Recently, transcranial bright light (TBL) via ear canals has been proved to modulate~     the neural networks of the human brain and improve cognitive performance in healthy subjects.~     Moreover, TBL has been found to alleviate symptoms of SAD in open trial. In this case the~     investigators will study the effect of transcranial bright light treatment via ear canals on~     depressive and anxiety symptoms in patients suffering from SAD in randomized controlled~     double-blind study design.~   "
136182|NCT01784692|"~     This will be a small study aimed at determining the effects of oral Immulina consumption on~     the immune system in elderly individuals.~   "
136183|NCT01784679|"~     HIBM is a severe progressive myopathy that typically presents in early adulthood as weakness~     in the distal muscles of the lower extremities and progresses proximally, leading to a loss~     of muscle strength and function, and ultimately a wheelchair-bound state. The rate of~     progression is gradual and variable over the course of 10-20 years or longer. There is a need~     to better understand the disease-specific features of HIBM to heighten disease awareness;~     facilitate early diagnosis; identify patients; expand knowledge of the clinical presentation,~     progression and variation of the disease; identify and validate biomarkers and other efficacy~     measures; inform on the design and interpretation of clinical studies of investigational~     products; and eventually to optimize patient management.~   "
136184|NCT01784666|"~     This study investigates the medication isradipine, which is currently approved by the FDA to~     treat high blood pressure, in the treatment of depression in bipolar disorder. Isradipine or~     placebo (contains no active medication) will be used as an add-on to lithium, valproate,~     and/or atypical antipsychotics for individuals currently experiencing a major depressive~     episode. Our hypothesis is that isradipine will be superior to placebo in improving~     depressive symptoms.~   "
136185|NCT01784653|"~     The purpose of this study is to test the effects of a computerized, self-directed~     Motivational Enhancement Therapy program for adolescent substance use (iMET), in comparison~     to clinician-delivered MET and Treatment As Usual (TAU), on treatment engagement and~     substance use. The investigators hypothesize that both iMET and MET will be more effective~     than TAU in engaging/retaining patients in treatment and in reducing substance use during a~     12-month follow-up period. The investigators also hypothesize that Self-directed iMET will be~     as effective as the clinician-guided MET in increasing treatment engagement and abstinence~     during the 12-months follow-up period.~   "
136186|NCT01784640|"~     This phase I trial studies the side effects and the best dose of Hsp90 inhibitor AUY922 when~     given together with pemetrexed disodium in treating patients with previously treated stage IV~     non-small cell lung cancer. Hsp90 inhibitor AUY922 may stop the growth of tumor cells by~     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as~     pemetrexed disodium, work in different ways to stop the growth of tumor cell, either by~     killing the cells or stopping them from dividing. Giving Hsp90 inhibitor AUY922 together with~     pemetrexed disodium may kill more tumor cells~   "
136187|NCT01784627|"~     The goal of this project is to test the effectiveness of a computer-facilitated alcohol~     screening and brief intervention (c-ASBI) system for 12- to 18-year-old primary care patients~     in a multi-site, randomized comparative effectiveness trial. The investigators hypothesize~     that, among 12- to 18-year olds patients coming for annual well-care, those receiving c-ASBI~     will have lower rates of any alcohol use at 3-, 6-, and 12-month follow-ups compared to~     Treatment As Usual (TAU).~   "
136188|NCT01784614|"~     The aim of this study is to learn how different doses of LY2624803 affect sleep in healthy~     Japanese participants. The study has four treatment periods. Participants will receive a~     single dose of LY2624803 or placebo in each treatment period.~   "
136189|NCT01784601|"~     Primary objective of this study is to find out the incidence of hemi-diaphragmatic palsy~     associated with interscalene block done under ultrasound guidance.~      Primary hypothesis:~      • There is an incidence of hemidiaphragmatic palsy ranging fron 33-100 % after an~     interscalene block.~      Secondary hypothesis~        -  The incidence of hemidiaphragmatic palsy is much less than 33% when the block is done~          using ultrasound.~        -  The incidence of hemi-diaphragmatic palsy is directly proportional to volume of local~          anaesthetic injected.~        -  The incidence of hemi-diaphragmatic palsy is directly proportional to concentration of~          local anaesthetic injected.~   "
136191|NCT01784575|"~     Numerous factors prevent consumers from making effective use of publicly reported information~     about the quality of health care, including limited recognition that quality of care varies~     between physicians, lack of awareness of the existing quality websites, limited internet~     access, and low health literacy and numeracy. In the proposed randomized controlled trial we~     will evaluate the impact of providing assistance for using and interpreting information about~     the quality of pediatric care on the Massachusetts Health Quality Partners Quality Insights~     website among a population of low income pregnant women. Results of the study will advance~     our understanding of effective strategies for overcoming barriers to using publicly reported~     information among vulnerable populations.~   "
136192|NCT01784562|"~     The aim of the study is to assess safety, tolerability and clinical effects of different~     doses of riociguat in patients with inoperable Chronic Thromboembolic Pulmonary Hypertension~     (CTEPH) and who are not satisfactorily treated and cannot participate in any other CTEPH~     trial. In the US the study runs as an Expanded Access program under 21 CFR 312.320.~   "
136193|NCT01784549|"~     -  The investigators hypothesized that NSCL patients receiving therapy based on their~          baseline tumor markers levels would attain higher response rates than patients in the~          control arm receiving non customized therapy.~        -  patients with stage IIIA(N2) NSCLC will be randomized in a 2:1 ratio to customized~          therapy based on biomarkers status (ERCC1, RRM1, TS and EGFR mutation) vs standard~          chemotherapy.~        -  The primary objective of this multicenter trial is to compare pathological complete~          response of all subjects randomized, by treatment arm.~        -  Secondary objectives are to compare all randomized subjects by treatment arm for:~          response rate, disease-free survival, overall survival, one, two and three year survival~          and safety profile.~      The study is expected to demonstrate both the feasibility of this approach and the logistic~     problems associated with a biomarker-driven therapeutic strategy in NSCLC.~   "
136194|NCT01784536|"~     The purpose of this study is to examine the effects of oritavancin on the in vivo activities~     of CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP3A, NAT 2, and XO using a Cooperstown 5 + 1 cocktail~     in an open label, single arm manner.~   "
136195|NCT01784523|"~     In this multi-center international study, our aim is to determine the effectiveness of HCQ~     for primary thrombosis prophylaxis in persistently aPL-positive but thrombosis-free patients~     without systemic autoimmune diseases.~   "
136196|NCT01784510|"~     Randomized controlled trial comparing between two technique of laparoscopic sleeve~     gastrectomy for treatment of morbid obesity. In the first technique the investigators started~     dissection of gastrocolic ligament 6 cm from pylorus and in the second one the distance was~     only 2 cm. The main primary outcome measure was weight loss.~   "
136197|NCT01784497|"~     Health Related Quality of Life Assessment In Egyptian Recipients After Living Donor Liver~     Transplantation~   "
136198|NCT01784484|"~     BACKGROUND: Fibrosis assessment by Transient Elastography or Fibro scan is validated in~     chronic hepatitis C, however limited data are available in chronic hepatitis B and in non~     alcoholic fatty liver disease (NAFLD). AIMS: Document the prevalence and severity of fibrosis~     in patients with different chronic liver disease (elevated liver enzymes) who are being~     followed up in the liver unit and to find associated factors with significant fibrosis and~     cirrhosis at ziv medical center, Safed,Bar Ilan University. Israel. METHODS: Fibro scan will~     be performed to all patients with abnormal liver enzymnes who attend the liver clinic. Liver~     stiffness measurement, age, gender, BMI, will be measured. Questionaire on soft drink~     consumption, Coffee drinking, use of herbs, and a history of cancer or heart disease will be~     distributed. Expected RESULTS: we expect that the liver stiffness (normal 1-6 Kpa) will be~     higher in NAFLD patients than in viral hepatitis patients for the same age ,same BMI, and the~     same duration of disease. More over, we expect serum aspartate aminotransferase (AST) values~     will emerge as the most important independent predictive variable of fibrosis and not serum~     ALT. A significant correlations between soft drink and coffee consumption with the extent of~     liver fibrosis is also expected. CONCLUSIONS: This prospective study will confirm that~     screening patients with elevated liver enzymes is beneficial and detect earlier the presence~     of liver fibrosis mainly in patients with NAFLD.~   "
136199|NCT01784471|"~     This is a single-arm, single-center, open-label, pilot study . 30 subjects with foot symptoms~     attributable to diabetes or peripheral vascular disease will be screened . Subjects meeting~     inclusion criteria will sign informed consent and enrolled. All 30 subjects will be treated~     with the Magic Foot™.~      If there is any significant improvement in ICG or foot symptoms as obtained from self~     evaluation questionnaire, a further 30 subjects will be enrolled.~   "
136200|NCT01784458|"~     -  Intra-abdominal pressure(IAP) is defined as a steady state pressure of the abdominal~          cavity~        -  many studies have proved IAP as a prognostic factor that elevated IAP influences~          hemodynamics and multiple organs dysfunction~        -  In previous studies, most of them was based on the septic patients of medical diseases.~          And it is rare about sepsis of surgical diseases such as traumatized or postoperative~          patients~        -  We hypothesized that intra-abdominal hypertension may affect clinical course such as~          length of stay of intensive care unit, weaning of mechanical ventilation, proceeding of~          enteral feeding and mortality~        -  Our study was aimed to investigate prevalence of IAH and risk factors and to analyze~          clinical course and prognosis influenced by IAH in surgical patients with severe sepsis~   "
136201|NCT01784445|"~     Diclophenac potassium and ceftazidime are commercially available drugs that are used in~     various clinical situations. They are safe and known for years. Diclophenac potassium and~     Ceftazidime have been used in some studies for the prophylaxis and treatment of pancreatitis~     and Post-ERCP Pancreatitis (PEP). Diclophenac potassium, together with indometacin is~     currently standard treatment for prevention of (PEP) while ceftazidime is possible~     alternative treatment for patients with contraindications for nonsteroidal medicines. The aim~     of the study is to evaluate the efficacy of Ceftazidime for the prophylaxis of PEP.~   "
136202|NCT01784432|"~     Muscle performance is largely influenced by modulations in gene expressions of muscle tissue.~     In this context, low-level laser therapy has been used to improve muscle performance in~     experimental models and human researches. Thereby, the investigators examined modulations on~     global gene expression of muscle tissue influenced by exercise associated to low-level laser~     therapy.~   "
136203|NCT01784419|"~     This is a study of the short-term effects of ivacaftor on sweat chloride concentration and~     lung function in cystic fibrosis (CF) patients who fall outside current FDA approval. This~     new, first of its kind drug is approved for use only in CF patients with the G551D mutation~     in whom it safely confers considerable benefits. However, it is highly likely that CF~     patients with many other mutations can benefit similarly from this drug, some of whom can be~     identified by phenotype or genotype.~      We will enroll up to 30 CF subjects with clinical presentations in which there is one or more~     signs of residual CF channel function. The signs of residual function include: normal~     digestion, concentration of chloride in sweat between 55 and 85, or milder than expected CF~     disease in a CF patient with severe gene mutations. The primary outcome measure will be the~     difference in sweat chloride concentration measured in subjects on placebo and on ivacaftor.~     Secondary outcome measured will be lung function.~   "
136204|NCT01784406|"~     Women treated for gynaecological cancer perceive many difficulties in life on the personal,~     social, and physical levels. Today they are offered a 3 to 5 year follow-up programme at the~     hospital where the main purpose is to improve survival. However, the women are very nervous~     before follow-up visits and although they feel safe about them, they express that their needs~     of psychosocial care and self-management support are not fulfilled.~      The proposed study will test a person-centred intervention tailored the women's needs in a~     randomised controlled trial. The intervention will be based on the method Guided Self~     Determination (GSD), which has proved able to realize empowerment in practice in~     relationships between patients and healthcare professionals. GSD involves systematic use of~     condition-adjusted worksheets ('reflection sheets'), and advanced professional communication.~     Using reflection sheets filled out by each woman as the starting point for communication,~     problem solving will be tailored her personal needs. We expect that the intervention has the~     potential to support the women in better managing specific complications and difficulties~     related to concerns about recovery, body perception, fertility and establishment of intimate~     relations with their partner, all aspects important for the women's quality of life in the~     follow-up period after cancer diagnosis and treatment. The study will be the first to test~     GSD in cancer patients.~   "
136205|NCT01784393|"~     Pain from bone metastases of breast cancer origin is treated with localized radiation.~     Modulating doses and schedules has shown little efficacy in improving results. Given the~     synergistic therapeutic effect reported for combined systemic chemotherapy with local~     radiation in anal, rectal, and head and neck malignancies, the investigators sought to~     evaluate the tolerability and efficacy of combined capecitabine and radiation for palliation~     of pain due to bone metastases from breast cancer Hypothesis: Given the hypothesis that~     regimens employing greater intensity radiation yield higher rates of pain relief,~     radiosensitization using a tumor targeted drug like Xeloda should improve the rate of~     complete pain relief as compared to radiosensitization with 5FU alone.~      Primary Objective:~      To determine the frequency and duration of pain relief and narcotic relief for the proposed~     regimen.~      Secondary Objective:~      To determine the toxicity of concurrent Capecitabine and radiotherapy in breast cancer~     patients with bone metastases.~   "
136206|NCT01784380|"~     To explore whether Free androgen index（FAI）can be regarded as biochemically diagnostic~     indexes of high androgen hormone in blood of patients with Polycentric ovary syndrome（PCOS）.~     Also to explore whether Sex hormone-binding globulin（SHBG） and FAI can be seen as therapeutic~     effect indicatrixes of women with PCOS.~   "
136207|NCT01784367|"~     The study´s intention is to evaluate the feasibility, safety and effectiveness of a pump~     driven extracorporeal device for removal of carbon dioxide from the blood in oder to avoid~     intubation and invasive mechanical ventilation in patients with acute respiratory failure~     retaining carbon dioxide due to the failure of their ventilatory muscle pump and not~     responding to prior non-invasive mask ventilation.~   "
136208|NCT01784354|"~     The use of acupressure will be compared to targeted Raynaud's education and will evaluate~     the` frequency, duration and pain of Raynaud's attacks.~   "
136209|NCT01784341|"~     The overall aim of this project is to compare sleep patterns and melatonin profiles in~     individuals with bipolar disorder during depression and after remission. The hypothesis is~     that sleep time, rest-activity cycles and melatonin onset will be delayed during depression~     and become less delayed after remission.~   "
136210|NCT01784328|"~     To compare the Peristeen Anal Irrigation System with conservative bowel management in a~     prospective study among spinal cord injured patients with lower motor neuron neurogenic bowel~     dysfunction.~   "
136211|NCT01784315|"~     This research is intended to study the efficacy of CQ alone for P.vivax infection and also to~     study the recurrence rate among patients with P.vivax on standard dose of CQ and PQ. For this~     study, PQ will be withheld for 28 days so as to study the efficacy of CQ alone since masking~     effect over one another was found when CQ is given with PQ. So the investigators are not sure~     whether the recurrence is due to resistance to CQ or CQ concentration in blood is below~     therapeutic level or it is due to PQ is in inadequate dose. From this study the investigators~     will get findings like may be CQ is still working for P.vivax or no longer working for~     P.vivax due to resistance developed by P.vivax parasites. So for P.vivax which is not~     responding to CQ therapy, the investigators will go for second line treatment with ACT in a~     similar fashion as it is given for P. falciparum infection in Bhutan. And if the~     investigators find CQ is still working for P.vivax infection, the next level of study will be~     to compare higher dose of PQ with standard dose of PQ ( as practiced now) in lieu of bringing~     down the relapse rates in P. vivax infection.~   "
136212|NCT01784302|"~     This study seeks to address the question of whether antacids or multivitamins influence the~     pharmacokinetics of raltegravir when co-administered. The aim of this study is to optimise~     the dosing of raltegravir when co-administered with antacids or multivitamins.~   "
136248|NCT01783834|"~     To compare the efficacy of gefitinib versus pemetrexed as second-line chemotherapy for~     patients with previous treated non-small cell lung cancer~   "
136249|NCT01783821|"~     This study tested whether inhaled budesonide and formoterol were able to alleviate or prevent~     pulmonary injury when administered early in hospital course to the patients at risk for~     developing acute respiratory distress syndrome (ARDS). The FDA has approved many uses for~     budesonide and formoterol, including asthma and chronic obstructive pulmonary disease (COPD),~     but the use of these two drugs is experimental for ARDS.~   "
136213|NCT01784289|"~     White adipose tissue-related diseases spread from excess (obesity) to lack (lipoatrophies)~     through aberrant distribution (lipodystrophies), these 3 different disorders being~     paradoxically able to induce a metabolic insulin resistance syndrome. The respective part of~     quantitative and qualitative anomalies of adipose tissue, gluco- and lipo-toxicity, liver and~     muscle insulin resistance, low-grade fat inflammation and immune alterations are not~     perfectly understood in the metabolic syndrome yet. Therefore, the aim of this study is to~     assess different cytokines, especially interleukin 7, and metabolic parameters as well as fat~     mass distribution with DEXA and RMN, in different models of fat distribution, including~     normal-weight, obese and lipodystrophic patients. A plasma serum, gene and adipose tissue~     bank will be constituted at the same time to improve our knowledge in disorders linking fat~     mass, insulin resistance and immunity, especially in lipodystrophies, a rare monogenic model~     of insulin resistance.~   "
136214|NCT01784276|"~     Specific Aims Our study objective is to investigate if video peer modeling before the visit,~     plus immersive virtual reality during a preventive dental visit, reduces dental fear and~     uncooperative behaviors among children with ASD.~      SPECIFIC AIM: To pilot and test the feasibility and effectiveness of video peer modeling and~     immersive virtual reality in reducing dental fear among children with autism undergoing~     preventive dental visits.~      Methods: The investigators will enroll eighty (80) subjects aged 7-17 years with a known~     diagnosis of autism, who had a history of dental fear, per parental report.~      Study hypotheses:~      The primary hypotheses of interest are:~      (i) The mean change in the Venham Anxiety Score (VAS) over the 4 month period in children~     with ASD who receive the video intervention (Group B) is different from the mean change in~     the VAS over the 4-month period in children with ASD in the control group.~      (ii) The mean change in the VAS over the 4-month period in children with ASD who receive the~     immersive VR intervention (Group C) is different from the mean change in the VAS over the~     4-month period in children with ASD in the control group.~      (iii) The mean change in the VAS over the 4-month period in children with ASD who receive the~     video intervention plus the immersive VR intervention (Group D) is different from the mean~     change in the VAS over the 4-month period in children with ASD in the control group.~      The secondary hypothesis is:~      (i) The mean change in the Venham Behavior Score over the 4-month period in children with ASD~     in Group D is different from the mean change in the Venham Behavior Score over the 4-month~     period in children with ASD in Group B or C.~   "
136215|NCT01784263|"~     The study is a randomized controlled trial to examine the efficacy of individual cognitive~     behavioral therapy (CBT) relative to a standard community treatment, in youngsters with~     autism spectrum disorder (ASD). The individual CBT program has been tailored over the last~     five years to the clinical needs of high-functioning youth with ASD.~   "
136216|NCT01784250|"~     The aim of the study is to determine the efficacy of clonidine and propranolol for transient~     anxiety management and intra and postoperative pain in patients undergoing ambulatory surgery~     of third molar.~   "
136217|NCT01784237|"~     A sniff test for nasal patency is a common method before ultrathin transnasal~     esophago-gastro-duodenoscopy (UT-EGD) to select the right or left nostril for insertion, yet~     there is no objective method to select an appropriate meatus insertion site (MIS) where~     tolerance and epistaxis rate can be improved.~      The investigators hypothesize that that an objective anterior rhinoscopy (to be more~     specific, the investigators term it anterior meatoscopy) method might be more effective~     than the subjective breathing-in method (sniff test) to select the appropriate meatus~     insertion site, thus reducing nasal bleeding and nasal discomfort.~      The aim of this study is to evaluate the effectiveness of an endoscopic meatus scoring scale~     (EMSS) by anterior meatoscopy (AM) to select a MIS on patient tolerance and adverse events~     during nasal anesthesia and UT-EGD.~      The investigators will perform a prospective randomized-controlled trial to compare patient~     tolerability and adverse events during nasal anesthesia and endoscopy between the AM-selected~     and self-selected MIS. A total of 233 consecutive patients with epigastric discomfort~     (symptoms of non-ulcer dyspepsia) will be included in the study in a large tertiary referral~     hospital in Taiwan.~   "
136218|NCT01784224|"~     The main purpose of this study is to investigate voice production, speech intelligibility and~     routine physiologic parameters associated with the Blom low profile voice inner cannula and~     the Passy-Muir one-way tracheotomy tube speaking valves.~      Additionally, the purpose of this study is to investigate the effects (if any) associated~     with the Blom low profile voice inner cannula and the Passy-Muir one-way tracheotomy tube~     speaking valves on swallowing behavior and biomechanical movement of the hyolaryngeal complex~     during routine diagnostic modified barium swallowing evaluations.~   "
136219|NCT01784211|"~     The purpose of this study is to measure how much of the study drug or insulin glargine gets~     into the blood stream and how long it takes the body to get rid of it. The effect of exercise~     will also be evaluated.~      This study has two parts. In Part A, each participant will receive a daily injection of~     LY2605541 or insulin glargine for about 15 days. Some participants may continue into Part B.~     In Part B, participants will receive a daily injection of LY2605541 or insulin glargine with~     or without exercise. Part B lasts about 6 days.~      Participants will remain on their regular physician-prescribed meal time insulin throughout~     the study.~   "
136220|NCT01784198|"~     Protein is an essential part of our diet. It is used to build muscle and body tissue, send~     signals throughout our body and to support the immune system. Dietary protein is even more~     crucial during pregnancy as it is needed for healthy growth and development of the baby.~     There is very minimal data available on how much additional protein is required during~     pregnancy. Current recommendations are based on older techniques such as nitrogen balance~     studies of non-pregnant adults and minimally based on pregnancy specific data. There is no~     scientific information regarding the amount of protein needed during different stages of~     pregnancy.~      The investigators hypothesize that the current recommendations of protein intake during~     pregnancy are underestimated.~      The goal of this study is to measure protein requirement in healthy pregnant women~     (19-35y)using a more quick and modern technique called the indicator amino acid oxidation~     technique (IAAO).~   "
136379|NCT01782131|"~     The purpose of this study is to evaluate the safety and efficacy of posaconazole versus~     voriconazole in the treatment of adults and adolescents with invasive aspergillosis (IA).~   "
136938|NCT01774825|"~     After 2 weeks of run-in period, subjects are randomized to either IQP-CL-101 or a matching~     placebo. Over 8 weeks, the subjects are monitored for improvements in IBS symptoms~   "
136221|NCT01784185|"~     The study has been designed to evaluate the clinical application of the new virtual~     bronchoscopy (VB) -based system for transbronchial sampling of the mediastinal masses or~     enlarged lymph nodes. The software uses data from thorax CT scan and enables airway~     segmentation and reconstruction simultaneously with predefined mediastinal targets. The most~     suitable sites for transbronchial needle aspiration are displayed on the internal surface of~     the airways showed in VB mode.~      The diagnostic yield of the new system-assisted TBNA will be compared to the reference method~     (EBUS-TBNA). The study group includes patients with mediastinal mass or lymph node~     enlargement in whom diagnostic bronchoscopy and TBNA can be applied as diagnostic methods.~     Both, virtual bronchoscopy guided transbronchial needle aspiration (VB-TBNA) and EBUS-TBNA of~     the mediastinal targets are performed during the same diagnostic bronchoscopy. Cytologic~     material from VB-TBNA and EBUS-TBNA is evaluated by two independent pathologists blinded to~     the method used to obtain the sample. Diagnostic yield and adequacy of aspirates obtained~     with the two methods will be assessed and compared.~   "
136222|NCT01784172|"~     The purpose of this study is to evaluate the efficacy and safety of electroacupuncture （EA）~     for simple female stress urinary incontinence.~   "
136223|NCT01784159|"~     Platelet activation is an important factor in the pathogenesis of microvascular thrombosis~     characteristic of infections. Microthrombosis may be related to the progression of~     dysfunction during sepsis. Several drugs were tested in order to directly regulate blood~     clotting. However, there is a lack of studies on aspirin use in sepsis. Observational studies~     have demonstrated a decreased morbidity and mortality of sepsis with previous use of aspirin.~     However, no prospective randomized studies regarding this intervention were done. The~     objectives of this study are to evaluate the impact of the use of aspirin in reducing organ~     dysfunction measured by SOFA score on the seventh day, and assess its effect on the duration~     of mechanical ventilation, ICU and hospital stay, as well as platelet activity, inflammatory~     and prothrombotic activity. Thus, adult patients with severe sepsis and / or septic shock~     with less than 48 hours will be randomly allocated into two groups. Group 1 (ASA) will~     receive aspirin 200 mg and Group 2, placebo either once daily for 14 days. The inflammatory~     status and coagulation will be collected either in the D0 and D3, with measurements of~     interleukin 6, interleukin 10 and interleukin-8. The coagulation profile will be analyzed by~     measuring thrombin-antithrombin complex, thrombin time, d-dimer and tissue factor. The~     platelet activity will be evaluated by testing platelet function (PFA) and by measurement of~     urinary metabolites and thromboxane.~   "
136224|NCT01784146|"~     Objective: To assess the influence of nebulization with bronchodilators carried by the heliox~     coupled to PEP in the distribution of compartimental lung volumes in asmathic adults and to~     correlate with pulmonary function data. Methods: A controlled randomized trial involving 27~     patients divided into four groups: heliox + PEP, oxygen + PEP, heliox and oxygen. After the~     initial evaluation, it was placing 89 reflective markers attached to the surface of the trunk~     and images acquired by optoelectronic plethysmography (OEP) of six cameras. Three slow vital~     capacity maneuvers and quiet breathing regarded as phase control. After the control phase,~     all patients underwent nebulization with a distribution noninvasive system, semi-closed using~     10 drops of Fenoterol Bromide and 20 drops of Ipratropium.~   "
136225|NCT01784133|"~     The purpose of this study is to evaluate th safety and efficacy of one-daily topical~     application of CLS001 low, mid and high dose compared to vehicle gel in subjects with~     papulopustular rosacea.~   "
136226|NCT01784120|"~     To evaluate efficacy and toxicity of doxorubicin/Genexol-PM in metastatic breast cancer~        1. Primary Purpose: response rate~        2. Secondary purpose: toxicity, progression-free survival, overall survival~   "
136227|NCT01784107|"~     Phase 1 : To evaluate MTD(Maximal tolerated dose)and DLT(Dose limiting Toxicity) of Belotecan~     and Ifosfamide.~      Phase 2 : To analyse efficacy and toxicity of Belotecan and Ifosfamide.~   "
136228|NCT01784094|"~     This study aims to compare the Connective Tissue Motion Measure (CTMM) in low back pain and~     no-low back pain subjects, evaluate the reliability of the CTMM, and examine the correlation~     of CTMM with low back pain symptoms, disability, and functional measures. The investigators~     hypothesize that CTMM will be reduced, on average, in low back pain subjects, that CTMM will~     be reliable with an intra-class correlation greater than 0.8, and CTMM will negatively~     correlate with low back pain symptoms, disability and functional measures.~   "
136229|NCT01784081|"~     The main purpose of this study is to evaluate the acceptance by patients with metastatic~     pancreas cancer of integrating palliative care with usual cancer treatment. Palliative care~     intervention will involve use of pancreas cancer-specific decision aides (iPC3)about~     prognosis, treatment choices, and advance care planning for patients facing a treatment~     decision as well as symptom assessments. We hypothesize that palliative care consultations~     with iPC3 will be accepted, symptoms can be diminished, information can be received in a way~     that improves choices, and that the quality of care can be improved.~   "
136230|NCT01784068|"~     The main purpose of the study is to investigate whether nilotinib treatment can be safely~     suspended with no recurrence of CML in selected patients who responded optimally on this~     treatment~   "
136231|NCT01784055|"~     To monitor the long-term performance of the CE Marked NeoChord Artificial Chordae Delivery~     System~   "
136232|NCT01784042|"~     The over-reaching goal of this study is to test the merit of combining dietary energy~     restriction with omega-3 fatty acids as a safe and effective breast cancer chemoprevention~     strategy in overweight and obese women at high risk.~   "
136233|NCT01784029|"~     To compare the efficacy of two high dose vitamin D3 regimens (5,000 IU daily vs. 50,000 IU~     weekly) used clinically for the treatment of vitamin D deficiency versus a low dose of~     vitamin D3 used for supplementation (1,000 IU daily) in a clinical sample of predominantly~     Hispanic and black adolescents with vitamin D deficiency [25(OH)D level <20 ng/ml] by~     assessing change in 25(OH)D levels before and after 8 weeks of treatment.~      To compare the effects of vitamin D repletion [25(OH)D level >20 ng/mL] on selected~     musculoskeletal, cardiometabolic and immune markers in predominantly Hispanic and black~     adolescents with vitamin D deficiency [25(OH)D level < 20 ng/mL].~      Hypothesis 1: Increase in vitamin D level will be associated with improvement in~     musculoskeletal, cardiometabolic, and immune markers including blood pressure, waist~     circumference, musculoskeletal symptoms, asthma severity and hand-grip strength.~   "
136234|NCT01784016|"~     This trial aims to determine whether dopamine D3 receptors are elevated in smokers versus~     nonsmokers and whether correlations exist between D3 receptor binding potential (BP) and~     functional MRI (fMRI) reactivity to smoking cues, which has been associated with smoking~     relapse vulnerability.~      Neuroimaging measures of D3 BP and smoking cue fMRI reactivity will be collected concurrently~     in otherwise healthy nicotine-dependent smokers and age-matched nonsmokers using a 3 Tesla~     MRI scanner configured to conduct fMRI and Positron Emission Tomography (PET).~      We will measure D3 receptor BP using radiolabeled [11C]-(+)-PHNO, which has a relatively~     higher affinity for D3 versus D2 receptors.~      We hypothesize that D3 BP will be elevated in smokers versus nonsmokers and that in smokers,~     there will be a positive correlation between smoking cue fMRI reactivity and D3 BP.~   "
136235|NCT01784003|"~     The proposed study aims to characterize biological ankle joint function during walking and~     running on slopes in order to further develop advanced powered ankle-foot prostheses. Ankle~     joint torque and angle data will be collected from non-amputees while walking and running at~     multiple speeds and slopes. This data will be used to develop control parameters for a~     powered ankle-foot prosthesis. Then, these parameters will be implemented and tested in a~     powered prosthesis worn by people with below the knee amputations.~   "
136236|NCT01783990|"~     The BABY HUG Treatment Study was designed to see if treatment with the drug hydroxyurea (also~     called HU) in children with sickle cell disease could prevent organ damage, especially in the~     spleen and kidneys. There was also a chance that treatment could prevent painful crises, lung~     disease, stroke, and blood infection.~   "
136237|NCT01783977|"~     NOTE: This study has stopped enrolling new participants, and all study vaccinations for~     currently enrolled participants have been stopped.~      Currently, there are no vaccines approved for the prevention of HIV infection, but there are~     many clinical trials taking place that are studying experimental HIV vaccines. The purpose of~     this study is to evaluate the safety and tolerability of three different HIV vaccine~     schedules in healthy, HIV-uninfected adults.~   "
136238|NCT01783964|"~     This study is performed to measure the quantity of i.v. applied elacytarabine that leave the~     body, by which route and how fast.~   "
136239|NCT01783951|"~     The purpose of this study is to evaluate the antitumor effect and safety of clinical~     effectiveness dendritic cell activated Cytokine induced killer treatment (DC-CIK) plus S-1~     based chemotherapy for advanced gastric cancer.~   "
136240|NCT01783938|"~     The purpose of this study is to evaluate the safety and efficacy of a sequential combination~     therapy of Nivolumab and Ipilimumab~   "
136241|NCT01783925|"~     The objective of this PMS is to gain information about safety and efficacy in real practice~     as a regulatory commitment required by MFDS~   "
136242|NCT01783912|"~     This study tests whether pre-cessation interventions known to be effective in the general~     population will increase acceptance of evidence-based treatment, engagement and compliance~     with that treatment and initial quitting success. One hundred and seventy two patients will~     be recruited from 13 Community Support Programs (CSPs). CSPs provide community based care to~     those diagnosed with persistent and serious mental illness. All participants will receive two~     group sessions (40 minutes each) modeled after Kicking Butts, a group-based quitting~     preparation program used for the past four years in two Milwaukee CSP programs run by~     Wisconsin Community Services. Individuals will then be randomly assigned to the experimental~     and control conditions (n=86 each). Experimental subjects will receive four evidence-based~     preparatory interventions (motivational interviewing, smoking reduction, practice quit~     attempt, and pre-quit use of nicotine replacement medication) (25 - 30 minutes each).~     Attention control subjects will also receive four individual sessions of the same duration.~     However their individual sessions' content will be a discussion of the personal relevance of~     the group material and will not include any of the preparatory interventions. Data will be~     collected via brief surveys taken pre-intervention, at the end of the last individual~     session, and three months later and from a database provided by the Wisconsin Tobacco Quit~     Line (WTQL).~   "
136243|NCT01783899|"~     The objective of this study is to assess the effectiveness of Hemospray in achieving initial~     hemostasis and decreased rate of re-bleeding in patients of acute variceal bleeding.~   "
136244|NCT01783886|"~     To determine the efficacy of intravitreally (IVT) administered VEGF Trap-Eye on the~     best-corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy~     study (ETDRS) chart in subjects with diabetic macular edema (DME) with central involvement.~   "
136245|NCT01783873|"~     Occupational asthma (OA) caused by high molecular weight (HMW) substances have been shown to~     induce predominantly an eosinophilic inflammation. In contrast, OA caused by low molecular~     weight (LMW) substances results in a neutrophilic inflammation. In addition, data regarding~     phenotype of lymphocytes in OA caused by HMW and LMW substances are scarce. The use of a new~     equipment will allow the realization of specific standardized bronchial challenges (BC) to~     occupational agents. Thus, we propose to study in more detail the cellular mechanisms~     involved during BC to HMW and LMW occupational agents in a double-blind placebo controlled~     study.~   "
136246|NCT01783860|"~     One hundred patients with the diagnosis of posterior blepharitis based on history taking and~     proper physical examinations by two experienced ophthalmologists will include in the study.~      Patients will diagnose with posterior blepharitis if they score at least one in two symptoms~     (based on a subjective grading scale) and two signs (based on an objective grading scale) of~     posterior blepharitis according to study criteria. Patients will exclude if they have the~     following criteria: age< 12 years old,history of previous ocular or lacrimal surgery,previous~     usage of contact lenses,any history of ocular allergy,history of systemic diseases with~     ocular involvement (except rosacea), history of usage of topical or systemic antibiotic in~     the last month, pregnancy or lactating mothers, liver failure and any history of sensitivity~     to cyclines.~      Qualified patients then randomly receive oral azithromycin (2 of 250 mg capsules for the~     first day and 250mg for the next 4 days) or oral doxycycline (100mg capsule every 12 hours~     for one month) in a double-blinded fashion. each patients in both treatment groups will~     accurately instruct to apply warm compress and eyelid scrubbing 2 times a day for 5 minutes~     each in the treatment period. Symptoms and signs were recorded for each patient in two~     treatment groups at baseline visit (before treatment) and then in the days 7, 31, 37 and 61~     after treatment.~   "
136247|NCT01783847|"~     The pathophysiology of Traumatic Optic Neuropathy (TON) is thought to be multifactorial, and~     some researchers have also postulated a primary and secondary mechanism of injury.TON is~     categorized as direct or indirect.In indirect TON cases, the injury to the axons is thought~     to be induced by shearing forces that are transmitted to the fibers or to the vascular supply~     of the nerve. Studies have shown that forces applied to the frontal bone and malar eminences~     are transferred and concentrated in the area near the optic canal. The tight adherence of the~     optic nerve's dural sheath to the periosteum within the optic canal is also thought to~     contribute to this segment of the nerve being extremely susceptible to the deformative~     stresses of the skull bones. Such injury leads to ischemic injury to the axons of the retinal~     ganglion cells within the optic canal. At present, no studies validate a particular approach~     to the management of TON. There are three management lines for these patients that include~     1)observation only;2)medical treatment with high or megadoses of methylprednisolone; and~     3)surgical intervention. Generally no line precedes the others and additionally, medical or~     surgical interventions may result in serious side effects or complications. In 2005, the~     results of the Corticosteroid Randomization after Significant Head Injury (CRASH) trial~     raised concerns regarding the use of mega dose steroids in traumatic brain injury. This study~     was the largest randomized study that evaluated steroids in patients with traumatic brain~     injury and was stopped early due to the significantly increased risk of death in patients~     that received mega dose steroids at their 6-month follow-up when compared with the placebo~     group (25.7% vs 22.3%; Relative Risk 1.15 Confidence Interval 1.07 to 1.24; p=0.0001).~     Although the etiology of the increased risk of death was not determined, the findings of this~     study should be taken into consideration when managing cases of TON with concurrent traumatic~     brain injury. Very recently it has been shown the cytokine hormone erythropoietin (EPO) that~     had been long known and used as a valuable agent to promote hematopoiesis has been protective~     in experimental models of mechanical trauma, neuroinflammation, cerebral and retinal~     ischemia, and even in a human stroke trial, and most notably in optic nerve transection. A~     double blind placebo-controlled multicenter trial on EPO add-on treatment in chronic~     schizophrenic men was performed. Treatment over 12 weeks with high-dose weekly (40,000 IU~     intravenously) EPO led to significant improvement of cognitive performance compared to~     placebo controls. Different studies have been performed on the effect of EPO on neuropathy in~     different studies. The investigators recently published our results on treating patients with~     TON with EPO and found it safe and effective. Patients were compared with a historical~     control group of patients who received no treatment for TON. A better visual recovery was~     found. The aim of this study is to determine the effectiveness of EPO on TON in a Multi-~     center clinical trial using a semi-experimental design.~   "
136250|NCT01783808|"~     The purpose of this trial is to study the effects on exercise capacity, physical activity,~     inflammatory markers and quality of life of supplemental ambulatory oxygen, to be used during~     physical activity, in patients with COPD who are normoxic at rest but hypoxemic during a~     six-min walk test.~      Our hypothesis is that if patients are able to use supplemental oxygen they will be more~     physically active and thereby improve health related quality of life.~   "
136251|NCT01783795|"~     This study will help the investigator determine whether certain genetic mutations, more than~     others, are a cause of more severe disease in Dent Disease.~   "
136252|NCT01783782|"~     The primary aim of this prospective, randomized and controlled study was to evaluate the~     effect of five bowel preparation regimens on small-bowel cleansing in a pediatric population.~     The secondary endpoints were to evaluate the safety and the effects of preparation on~     diagnostic yield of CE.~   "
136253|NCT01783769|"~     All eligible patients who will have neurosurgery at Barrow Neurological Institute (BNI)~     between March 1, 2013 and February 28, 2014 will be enrolled as part of this study that will~     look at the flow of staff people in and out of the operating room during surgeries and the~     effect that the number of people may have on the rate of infections in the surgical sites.~   "
136254|NCT01783756|"~     This is a phase 1b/2 study to evaluate the safety and clinical activity of the combination of~     lapatinib, everolimus and capecitabine for the treatment of participants with HER2+ breast~     cancer with metastases in the brain who have progressed on trastuzumab.~      The combination of 2 drugs able to reach the brain (lapatinib and everolimus) that target~     different parts of the HER2 signaling pathway plus chemotherapy (capecitabine) that has~     proven benefits in metastatic breast cancer may lead to improved clinical outcomes for~     participants with CNS metastasis.~      Participants will undergo brain MRIs and CT scans of the chest and abdomen to evaluate~     response to the treatment, regular laboratory tests and echocardiogram or Multi Gated~     Acquisition Scan (MUGA) to assess cardiac activity~   "
136255|NCT01783743|"~     To achieve the goal of trachoma control as mandated by the World Health Organization,~     countries must reduce the backlog of trichiasis surgery cases to less than 1/1,000 of their~     population. However, these cases reside in rural villages in trachoma endemic districts, and~     finding them to offer services is a challenge. Community Treatment Assistants (CTAs) are~     village residents who are trained to offer Mass Drug Administration (MDA) to their~     communities and hence are in contact with most residents. A training guide and tool for~     screening for trachomatous trichiasis (TT) will be developed to train CTAs in rural Tanzania~     to identify cases in their communities and refer them to surgery. Compared to the current~     process by which CTAs passively screen for TT if cases complaint, investigators hypothesize~     that the trained CTAs will identify twice the usual number of TT surgery cases during ongoing~     community antibiotic administrations for trachoma and will also miss fewer cases. If this~     simple system is effective, it can be implemented widely to screen communities for cases of~     TT.~      Residents from thirty-six villages holding MDA, for whom a complete census is available, will~     be randomized on a 1:1 basis to intervention (where the CTAs receive the enhanced training~     from the enhanced training team) and usual assessment (where the CTAs receive the usual~     instructions from the regular MDA team). In both arms, the CTAs will keep records of all~     cases they have screened as positive for TT amongst the residents.~      A Master TT grader will grade all screened cases of TT to determine the rate of true~     positivity in both arms.In addition, he will examine a random sample of residents who are~     screened as negative to detect potentially missed cases and estimate the total burden of~     trichiasis cases in both arms as well.The assessments of the Master TT grader will serve as~     the gold standard for calculations of sensitivity, specificity, and positive and negative~     predictive values of the enhanced training versus usual assessment methods.~   "
136256|NCT01783730|"~     This study was conducted to examine the safety profile and the effectiveness in daily~     clinical practice of adalimumab in rheumatoid arthritis participants showing rapid~     progression of structural damage of the joints, who had no prior history of treatment with~     disease-modifying anti-rheumatic drugs or biological agents.~   "
136257|NCT01783717|"~     The purpose of this study is to examine the effect of exenatide on body weight and glycemic~     control in subjects with obesity and/or diabetes mellitus due to hypothalamic damage.~   "
136258|NCT01783704|"~     Activity and exercise are believed to be of benefit for reducing disability in older adults,~     yet the majority of older adults do not participate in regular exercise and is not active.~     This is especially true for older adults following hip fracture after they complete the usual~     rehabilitation program.~      This study is being done to compare two 16-week supervised multi-part physical therapy~     programs (interventions) initiated up to 26 weeks after hip fracture. The investigators want~     to test whether the interventions lead to improvements in a person's ability to walk on their~     own in the home and in the local community. With this knowledge the investigators hope to~     help a greater number of hip fracture patients enjoy a more complete recovery and improved~     overall health.~      ANCILLARY STUDY #1 - MECHANISTIC PATHWAYS TO COMMUNITY AMBULATION (CAP-MP) The goal of this~     ancillary study is to investigate several mechanisms thought to be related to recovery in~     ambulatory ability after hip fracture. Selected mechanistic pathways are being investigated~     by obtaining mechanistic measurements of the participants randomized in the University of~     Maryland, Baltimore (UMB) clinical site of CAP.~      ANCILLARY STUDY #2 - DIET AND DIETARY PATTERNS IN OLDER ADULTS UNDERGOING HIP FRACTURE~     REHABILITATION The goal of this ancillary study is to analyze dietary patterns for the~     nutritional characterization of older adults recovering from a hip fracture. The identified~     dietary patterns, as well as motivators and barriers to intake, will be assessed for their~     impact on the rate of return to community ambulation in participants randomized at the~     University of Connecticut Health Center (UCHC) clinical site of CAP.~      ANCILLARY STUDY #3 - ROLE OF GLUCOSE METABOLISM IN STRENGTH AND FUNCTIONAL RECOVERY AFTER HIP~     FRACTURE The goal of this ancillary study is to assess the impact of glucose metabolism on~     strength and functional performance following resistance training in participants randomized~     at the UCHC clinical site of CAP.~      ANCILLARY STUDY #4 - MUSCLE MECHANISMS UNDERLYING RECOVERY OF FUNCTION AFTER HIP FRACTURE The~     goal of this ancillary study is to understand some of the key muscle mechanisms associated~     with recovery in community ambulation following hip fracture in response to the two~     interventions for participants randomized at the Arcadia University (AU) clinical site of~     CAP.~   "
136259|NCT01783691|"~     The purpose of this study is to determine the safety, pharmacokinetics, and pharmacodynamics~     of NKTT120 in adult patients with stable sickle cell disease.~   "
136260|NCT01783678|"~     This is an Open-label Phase 3 study in adults with chronic genotypes 1, 2, 3, and 4 HCV~     infection who are co-infected with HIV-1.~   "
136261|NCT01783665|"~     In addition to the typical motor and sensory impairments, individuals with multiple sclerosis~     (MS) often experience cognitive dysfunction and sleep disturbances. Cognitive impairment~     occurs in 40 % - 70% of patients with MS. In addition, sleep problems in individuals with MS~     are very common, and approximately 50% of patients with MS have a diagnosable sleep disorder.~     The research believes that aerobic exercise improve cognitive function and improve sleep~     quality.~   "
136323|NCT01782859|"~     Studies have shown that surgery causes some reactions in your body consistent with~     inflammation. When the inflammation is extensive, it may affect different parts of the body~     including the lungs. Corticosteroids are commonly used to treat inflammation and are~     different from performance enhancing steroids associated with athletics. The purpose of this~     study is to determine the influence of low dose steroids given 3 times in a 24 hour period on~     thrombotic markers (markers that are associated with increased risks of clotting, a possible~     complication of surgery), interleukin (IL)-6 cytokine release (part of the stress response~     seen with surgery), and urine desmosine levels (a marker of lung injury) in a randomized~     placebo controlled trial patients undergoing total hip replacement.~   "
136262|NCT01783652|"~     Objectives :~      The key objective of this study is to develop new interventions that addresses the diverse~     needs and circumstances of Hong Kong adolescents with depressive symptoms in community~     settings. Collaboration between medical professionals and social workers may prevent the~     occurrence of depression and misguided attempts to self-treat with alcohol and / or drugs in~     our adolescents.~      Methods :~      To address this intervention gap in the United States, Dr. Van Voorhees, a research~     collaborator of Dr. Chim and Dr. Ip, developed and conducted a phase 2 clinical trial of a~     primary care internet-based depression prevention intervention (CATCH-IT, Competent Adulthood~     Transition with Cognitive Behavioral Humanistic and Interpersonal training). It has been~     observed clinically that the strategy could reduce depressed mood, increased social support~     and reduced depressive episodes at 12 month follow-up.~      The investigators now propose to study if an adaptation of the CATCH-IT website for Hong Kong~     Chinese adolescents may lead to significant reductions in depressed mood. In this pilot~     trial, the investigators propose to test the efficacy of the Adapted and Translated version~     of CATCH-IT (AT-CATCH) against the placebo approach in preventing the onset of depressive~     episodes in a group of adolescents (aged 13-17) who have depressive symptoms, but have not~     developed depression yet.The case group will have access to the AT-CATCH website while the~     control group will only be allow to use the anti-smoking website.~      The investigators hypothesize that compared to youth in the control group, youth assigned to~     the AT-CATCH group will have a lower hazard ratio of major depressive episodes and decreased~     alcohol / drug use frequency over 2 years. Moreover, compared to youth in the control group,~     youth in the AT-CATCH program will demonstrate a steeper slope of improved symptoms through~     growth curve analysis and fewer depressed days over the study period.~   "
136263|NCT01783639|"~     The purpose of this study is to compare the safety and performance of WIRION™ EPD in patients~     undergoing carotid artery stenting to a performance goal based on an analysis of the results~     of previous US IDE carotid stenting with embolic protection studies~   "
136264|NCT01783626|"~     Evodial +hemodialyzer consists of an evolution of the existing CE marked Evodial device, with~     respect to the hemodialyzer membrane removal characteristics. Different membrane prototypes~     configurations are proposed (3 versions in total), with the objective to modulate the~     hemodialyzer removal capacities (convective and adsorptive capacities).~      Materials(including heparin grafted specifications) as well as the sterilization process are~     identical to the Evodial hemodialyzer. Based on available preclinical data , a clinical study~     is requested to document in vivo the different prototypes removal capacities with respect to~     middle Molecular Weight (MW) reference toxins such as b2 Microglobulin and collect data with~     regards to protein loss.~   "
136265|NCT01783613|"~     Cystic Fibrosis (CF) is a congenital disease secondary to the abnormal function of CFTR.~     Patients with CF have an alteration of essential fatty acids, Arachidonic Acid (AA) is~     increased and Docosahexanoic Acid (DHA) is decrease and the ratio ω-6/ ω-3 is elevated, all~     these alterations stimulated a chronic and bad regulated state of inflammation. For this~     porpoise, a fase IV trial, multicentric, controlled, double blind, placebo and parallel in~     patients elder than two months old and randomized to received every day a dietetically~     supplement with DHA or placebo, will be done during 12 months. The trial has as a principal~     objective to proved if this long term supplementation could decrease in contrast with~     placebo.~   "
136266|NCT01783600|"~     The objective of this clinical evaluation is to evaluate the immediate and long-term (up to~     12 months) outcome of NanoCrossTM balloon catheter (Covidien) in a prospective,~     non-randomised, controlled investigation for the treatment of patients with critical limb~     ischemia (Rutherford 4-5) due to the presence of lesions of minimally 10cm in length at the~     level of the below-the-knee arteries.~   "
136267|NCT01783587|"~     This research study is a Phase I clinical trial. Phase I clinical trials test the safety of~     an investigational drug. Phase I studies also try to define the appropriate dose of the~     investigational drug to use for further studies. Investigational means that the drug is~     still being studied and that research doctors are trying to find out more about it-such as~     the safest dose to use and the side effects it may cause.~      Afatinib has been studied in other clinical trials of participants with head and neck cancer,~     lung cancer, and breast cancer. This dose of Afatinib has also been studied in other research~     studies. This is the first clinical trial to study Afatinib in combination with Radiation~     Therapy.~      The purpose of this study is to determine the safest dose of Afatinib when given in~     combination with Radiation Therapy or in combination with Radiation Therapy and chemotherapy~     for head and neck cancer.~      Afatinib is a drug that may stop cancer cells from growing abnormally. This drug works by~     blocking multiple proteins known to play a role in the growth of cancer cells. Information~     from laboratory research studies suggests that this drug may help to make head and neck~     cancer cells more sensitive to Radiation Therapy.~      The other therapy in this research study is Radiation Therapy or Radiation Therapy plus a~     chemotherapy drug called Docetaxel. After surgery, Radiation Therapy and chemotherapy is the~     standard treatment if you have high risk disease. High risk disease means that without~     additional therapy, there is a high risk that the disease may return. In this study,~     participants with high-risk disease will receive Radiation Therapy and Docetaxel and~     Afatinib. Intermediate risk means that there is an intermediate risk that the disease may~     return. Radiation Therapy alone is the standard treatment approach for intermediate risk~     cancer. In this study, participants with intermediate risk disease will receive Radiation~     Therapy and Afatinib.~   "
136268|NCT01783574|"~     The investigators' hypotheses are: Low-dose testosterone augmentation improves depressive~     symptoms in women with Major Depressive Disorder (MDD) and antidepressant~     partial/nonresponse, adjunctive low-dose testosterone is safe and well-tolerated in women~     with MDD and antidepressant partial/nonresponse, and low-dose testosterone augmentation~     improves fatigue and sexual dysfunction.~   "
136269|NCT01783561|"~     Premature infants are at risk of having pauses in breathing, or apneas, due to their~     immaturity. Premature infants are routinely given caffeine, a respiratory stimulant, on the~     first day of life to prevent apneas. However, if they continue to have apneas, they may~     require a breathing tube to be placed in the trachea. There are risks to having a breathing~     tube, so it would be beneficial to avoid it if possible. If caffeine is given earlier, it may~     decrease the need for a breathing tube. Some studies also suggest that caffeine may also~     improve heart function which may prevent low blood pressure if given early.~   "
136270|NCT01783548|"~     The purpose of this study is to evaluate the efficacy and safety of Beclomethasone~     dipropionate (BDP) nasal aerosol in subjects with Perennial Allergic Rhinitis (PAR).~   "
136283|NCT01783379|"~     In this trial, our goal is to determine the pharmacokinetics of micafungin in a non-selected~     cohort of patients with suspected or proven invasive fungal infections. Patients will receive~     micafungin for the period necessary to achieve clinical and / or mycological cure. An attempt~     will be made to have 2 PK curves, one full and one limited sampling on days 3 (n=9) and 7~     (n=5). Furthermore, we will be able to determine intra-individual variability. On non-PK~     days, trough samples will be taken to determine the time to steady state. All samples will be~     taken just prior to the morning dose of micafungin. All infusion rates will be according to~     the SPC label information. Patients are considered to be evaluable if at least the first PK~     curve has been completed. Two moments of PK analysis will enable us to determine whether~     there is an increase over time in exposure if steady state has not been reached.~   "
136284|NCT01783366|"~     we first examined whether use of tube exchange catheter during NGT insertion could increase~     the success rate on the first attempt of NGT insertion compared with conventional technique.~     We then addressed the question of whether the use of tube exchange catheter might decrease~     the possible occurrence of complication associated with YOON insertion.~   "
136271|NCT01783535|"~     The primary objective of this protocol is to evaluate the response rate of bilateral disease~     participants who have at least one eye with advanced intra-ocular retinoblastoma (stratum B)~     using upfront therapy with chemotherapy delivered directly to the eye. The main biology~     objective is to improve our understanding of the biology and tumorigenesis (how tumor~     develops) of retinoblastoma when biology specimens are available. As clinicians, the primary~     goal of the investigators for children with retinoblastoma is to provide optimal therapy~     using multiple treatment approaches [chemotherapy (into the vein and directly into membrane~     of eyeball), cryotherapy (freeze and destroy tumor), thermotherapy (laser or heat to destroy~     tumor), radiation therapy, and surgical removal of eye if needed) in an attempt to preserve~     the eye and vision whenever possible, while still curing the disease. Therefore, all children~     with non-metastatic retinoblastoma at St. Jude will be offered enrollment on this study.~      PRIMARY OBJECTIVE:~        -  To evaluate the response (complete + partial response) rate of bilateral disease~          participants who have at least one eye with advanced intraocular retinoblastoma (Stratum~          B) to two upfront courses of therapy consisting of subconjunctival carboplatin and~          systemic topotecan.~      SECONDARY OBJECTIVES:~        -  To evaluate the ocular survival of eyes and event-free survival of participants by~          strata.~        -  To prospectively analyze intraocular disease tissue for participants with at least one~          eye undergoing enucleation in order to identify the mechanism of RB1 bi-allelic~          inactivation. Participants may undergo upfront enucleation (due to advanced disease at~          diagnosis) or may receive enucleation due to progressive disease during protocol~          therapy.~   "
136272|NCT01783522|"~     This randomized phase II trial studies glutamine in preventing peripheral neuropathy in~     patients with multiple myeloma who are receiving bortezomib. Glutamine may help prevent~     peripheral neuropathy in patients receiving chemotherapy~   "
136273|NCT01783509|"~     The purpose of this study is to understand more about limb-girdle muscular dystrophy.~     Therefore, the investigators would like to track the following information collected once a~     year from patients with GENETICALLY CONFIRMED LGMD: quality of life questionnaires, muscle~     strength, motor function, routine examination, assessment of patient (or parent)~     understanding of LGMD, and serum (blood) for growth factors, cytokines, and biomarkers (all~     parts of your blood). By tracking this information, we hope to be able to understand more~     about the diagnosis, progression and natural history of this disorder.~   "
136274|NCT01783496|"~     The purpose of this study to evaluate treatment with the Thermage CPT system for facial and~     neck laxity.~   "
136275|NCT01783483|"~     The primary objective of this study is to evaluate sternal bone healing following a full~     median sternotomy versus standard of care for sternal closure with wire cerclage. Additional~     outcomes on post-operative pain and analgesic usage, patient function and quality of life,~     and complications will also be collected. A health economics study will also be conducted, in~     which cost and billing data will be collected from sites participating in this clinical~     study.~   "
136276|NCT01783470|"~     This study will test the hypothesis that human brown adipose tissue (BAT) can be activated~     using a β3-adrenergic receptor (AR) agonist. The efficacy of β3-AR agonist will be compared~     with cold exposure, which we have already shown can activate human BAT, as well as a placebo~     control.~   "
136277|NCT01783457|"~     Treatment delay in psychosis usually lead to slower recovery, an increase in associated~     comorbidity and greater deterioration in social and family life of patients. Previous studies~     indicate that an early intervention with guidelines for increasing adherence to treatment,~     disease awareness and condition management leads to better progression of the disorder and is~     therefore related to a better prognosis.~      Several studies have found that the rate of relapse is higher in patients with~     pharmacological treatment alone compared to those also receiving psychoeducation, who tend to~     improve their adherence to treatment and reduce toxic drugs dosage.~      Hypotheses:~        -  Individual psychoeducation will be effective as complementary therapy to pharmacological~          treatment in patients with a first psychotic episode, improving disease evolution.~        -  BDNF levels will increase more in the patients receiving individual therapy compared to~          those without it.~        -  Psychoeducation can be performed similarly in all participating centers if the~          therapists receive the same training and use the same psychoeducation material.~        -  The use of telemedicine for the follow-up of the patients will help improve the welfare~          work and therefore the disease evolution.~   "
136278|NCT01783444|"~     This study will assess the efficacy and tolerability of everolimus and capecitabine~     monotherapies compared to everolimus/exemestane combination in woman with ER + advanced~     breast cancer.~   "
136279|NCT01783431|"~     This study is for subjects with a type of skin cancer called melanoma. The main purpose of~     this study is to examine the safety of the study drug (Poly-ICLC) in patients with your~     disease. The study team would like to know about any side effects a patient may have when~     given the study drug. Another goal of the study is to determine if combining dendritic cells~     and the study drug can be possibly used as a vaccine for your disease.~   "
136280|NCT01783418|"~     The purpose of this study is to evaluate the effects of a mindfulness-based meditation~     intervention on quality of life, sleep and mood in adolescents with cancer compared to a~     control group.~   "
136281|NCT01783405|"~     The objective of this project is to establish the current prevalence of cardiovascular~     disease in adult subjects suffering from genetically diagnosed HF, and to know the impact~     that drug treatment has course in cardiovascular disease when compared with that of their~     affected parents with a much longer period of exposure to hypercholesterolemia~   "
136282|NCT01783392|"~     This clinical trial testing three different sites of transcutaneous electrical nerve~     stimulation for the treatment of overactive bladder (OAB).~   "
136321|NCT01782885|"~     The purpose of this study is to test whether the platelet-rich plasma (PRP) intra-articular~     injection therapy is effective as an alternative treatment option in patients with mild knee~     osteoarthritis within a controlled randomized study compared to first line treatment~     acetaminophen. The investigators will evaluate patients outcome in level of pain, knee~     function and quality of life before the treatment and at 6, 12 and 24 weeks follow up.~      The study will be complemented with in vitro experiments of human osteoarthritic cartilage~     explants culture (treated with PRP) for histological and gene expression assays.~      PRP intra-articular injections therapy is effective in patients with mild knee osteoarthritis~     by modifying the biochemical joint environment and cartilage regeneration capability.~   "
136285|NCT01783353|"~     Up to one-third of common warts can remain recalcitrant, an occurrence that has been~     attributed to impaired cell-mediated immunity. At present, no guidelines exist for the~     management of recalcitrant cutaneous warts. Zinc, a well-established immunomodulatory agent,~     has shown promise in this regard. Previous studies documenting the efficacy of oral zinc used~     zinc sulfate given at a maximum dose of 600 mg/day, equivalent to 140 mg of elemental zinc,~     which is over three times the recommended upper limit of 40 mg of elemental zinc per day.~     This raises concerns over safety and tolerability. In the Philippines, oral zinc is more~     widely available in chelated forms such as zinc gluconate, which have the benefit of improved~     absorption compared to non-chelated compounds such as zinc sulfate. This study will seek to~     determine if zinc gluconate 300 mg/day, equivalent to 40 mg of elemental zinc, will be~     efficacious in treating recalcitrant cutaneous warts. This lowered dose may have the added~     benefits of increased safety, tolerability, and cost-effectiveness.~   "
136286|NCT01783340|"~     This study will assess the superior protective immunity of the combination of chloroquine and~     azithromycin prophylaxis under Chemoprophylaxis Sporozoites (CPS) immunization versus a~     standard chloroquine prophylactic regimen.~   "
136287|NCT01783327|"~     The purpose of this study is to evaluate the use of a state-of the art internet~     psycho-educational program in clinical practice (Teens-Connect), compared to use of a~     standard and widely available internet diabetes program for youth (Planet D™) in a~     mixed-method randomized clinical trial design.~   "
136288|NCT01783314|"~     When someone has hepatitis C or some other condition that causes liver injury, he or she can~     develop a condition called liver fibrosis that over time, can cause the liver to stop working~     normally. Currently, the best way to determine the degree of fibrosis is to do a liver~     biopsy. The investigators hope to show that measuring the degree of liver fibrosis using an~     MRI with gadoxetate disodium is as good as or better than obtaining this information by~     performing a liver biopsy. Gadoxetate disodium is a contrast solution given through the veins~     that is considered safe, is approved for use by the Food and Drug Administration, and is~     already routinely given to patients with various forms of liver disease, including fibrosis.~   "
136289|NCT01783301|"~     The overall objectives of this trial are to:~        -  To explore the efficacy and safety of using either antral follicle count (AFC) or~          anti-Mullerian hormone (AMH) to guide the starting dose of GONAL-f® in ovarian~          stimulation for Assisted Reproductive Technology (ART).~        -  To assess the differences in both ovarian response and clinical pregnancy rate between~          subjects with different AFC and AMH levels undergoing ART.~   "
136290|NCT01783288|"~     The purpose of the study is to determine whether patients meet criteria for Postural~     Tachycardia Syndrome (or not) and have reduced blood volume (or not). Both of these are~     important screening elements to Aim 3 of a National Institutes of Health Grant. The purposes~     of Aim 3 are to determine 1. whether a high dietary sodium level appropriately expands plasma~     volume in Postural Orthostatic Tachycardia, 2. whether plasma renin activity and aldosterone~     are modified appropriately by changes in dietary sodium in Postural Tachycardia Syndrome and~     3. whether patients with Postural Tachycardia Syndrome have improvements in their orthostatic~     tachycardia and symptoms as a result of a high dietary sodium level.~   "
136291|NCT01783275|"~     It is known that obesity and/or physical inactivity greatly increase a person's risk of~     developing heart disease and other serious health problems. This is partly because diabetes~     is associated with inflammation, oxidative stress, and insulin resistance. Diabetes is also~     associated with high levels of triglycerides in the blood and tissues such as the liver~     (known as fatty liver or steatosis). This elevation of fat in the liver is known to cause~     liver insulin resistance and impair the function of the liver and this impairment contributes~     to the development of diabetes.~      Studies have shown that both aerobic exercise and weight loss have beneficial results on~     insulin resistance. However, the cause of this benefit remains unclear. We know that both~     aerobic exercise and/or weight loss can improve how muscle responds to insulin. However, it~     is also known that aerobic exercise and/or weight loss lowers liver fat content, thereby~     making it possible that the liver's response to insulin is also improved by weight loss~     and/or exercise training. An improved responsiveness of the liver to insulin could lower~     blood sugar levels after a meal and it could also lower morning blood sugar levels. However,~     very little is known about how exercise and/or weight loss improves liver function in people~     with type 2 diabetes.~      Hypothesis 1: Improved hepatic insulin sensitivity, as a result of either exercise training~     or weight loss, will increase the amount of glucose from an oral load that is taken up by the~     liver in subjects with DM. We also hypothesize that the amount of glucose taken up by the~     liver will be increased even further in response to exercise training plus weight loss~     compared to either treatment alone.~      Hypothesis 2: Increases in hepatic insulin sensitivity as a result of exercise with weight~     loss will cause reductions in EGP during the fasted state, and will improve the suppression~     of EGP seen in response to hyperinsulinemia.~   "
136292|NCT01783262|"~     Evaluate if extracorporeal shock wave therapy is more effective than sham treatment in~     patients with trapezial-metacarpal osteoarthritis in pain relief and functional improvement.~   "
136293|NCT01783249|"~     That exercise will reduce anemia and fatigue, while improving aerobic capacity, strength and~     hematopoietic stem and progenitor cell mitochondrial function.~   "
136294|NCT01783236|"~     We will study the efficacy of FDA approved intravenous (IV) acetaminophen (Ofirmev, © 2011~     Cadence Pharmaceuticals, Inc.) in reducing opioid consumption after minimally invasive~     thoracic surgery in a double blind randomized trial. This drug has been shown in Europe to~     reduce the need for patient controlled analgesia and the total dose of opioids, which have~     serious side effects in thoracic surgery patients. We will compare the use of IV~     patient-controlled morphine (PCA) in two groups of subjects in treating postoperative pain.~     We will determine if IV acetaminophen reduces post-operative morphine requirements (primary~     end point). We will also assess subject pain scores and post-operative complications~     associated with pain management as secondary end points. Our hypothesis is that the study arm~     receiving intravenous acetaminophen will have lower total morphine consumptions compared to~     the placebo group.~   "
136295|NCT01783223|"~     This study is intended to evaluate the prevalence of chronically inebriated patients in the~     Emergeny Department (ED). Patients will be identified prospectively by screening all patients~     (24/7) presenting to the ED for one month. A running tally of all patients in the ED will be~     kept. Of these patients, any patient that is noted to have alcohol intoxication will be~     identified. The chart of that patient will be reviewed for details about the patient's~     alcohol use and for the patient's suitability for a sobering house, which is a place where~     intoxicated patients can go to await sobriety. The chart will also be reviewed for the number~     of previous visits for alcohol use to our hospital ever and in the last year.~   "
136322|NCT01782872|"~     The purpose of this study is to determine which medication(s) should be included in the~     interscalene nerve block (an injection of local anesthetic [numbing medicine] near nerves in~     the shoulder) for patients undergoing total shoulder arthroplasty (shoulder replacement). The~     ideal nerve block would reduce pain after shoulder surgery without causing a great deal of~     muscle weakness.~   "
136296|NCT01783210|"~     The investigators evaluate if changing eating habits and introducing a correct lifestyle in~     women with BMI >25 Kg/m2 would improve unfavorable maternal-fetal outcomes associated with~     excessive weight gain (EWG) during pregnancy. To pursue these goals, eligible women are~     randomly assigned to no intervention (Control group) that receive only a simple nutritional~     booklet about lifestyle and healthy diet during pregnancy without explicit caloric~     restriction or the Therapeutic Lifestyle Changes Program (TLC group) that receive a caloric~     restriction (1500 Kcal/day divided in3 main meals and 3 snacks + 300 kcal/die for overweight~     or 200 kcal/die for obese women submitted to energy expenditure program) associated to a mild~     physical activity (30 minutes at least 3 days/week) The investigators use a tool that could~     easily and practically evaluate not only total GWG at term, but also changes in maternal body~     composition: the bioimpedance analyzer.~   "
136297|NCT01783197|"~     This research is being done because further research on selumetinib in combination with~     standard chemotherapy treatment is needed. Although the number of treatment options for~     patients with advanced non-small cell lung cancer has increased over the past decade,~     prognosis remains poor, and there is a need for additional therapeutic options.~   "
136298|NCT01783184|"~     The Vascutek Anaconda™ Stent Graft System for repair of Abdominal Aortic Aneurysms (AAA) is~     the subject of this observational study. 180 patients will be implanted with the Anaconda™~     Stent Graft System and will be followed-up annually for 5 years post-implant. The study will~     satisfy the requirements of the French National Authority for Health (Haute Autorité de~     santé) and the data collected will be used for reimbursement renewal.~   "
136299|NCT01783171|"~     This randomized phase I trial studies the side effects and best dose of dinaciclib and Akt~     inhibitor MK2206 in treating patients with pancreatic cancer that cannot be removed by~     surgery. Dinaciclib and Akt inhibitor MK2206 may stop the growth of tumor cells by blocking~     some of the enzymes needed for cell growth.~   "
136300|NCT01783158|"~     Patients with HNSCC represent a high-risk group for the development of SESCC. Thus,~     esophagogastrofibroscopy should be performed to detect possible synchronous esophageal~     carcinomas in these patients.~      Although only two patients with synchronous primary carcinomas were found among the patients~     with newly diagnosed HNSCC in this study, esophagoscopy and better some of advanced~     endoscopic methods should be recommended after detection of HNSCC to exclude secondary~     esophageal carcinoma or dysplasia. Staining of the esophagus with Lugol's solution is an easy~     and inexpensive option and can be done in most of gastroenterology offices.~   "
136301|NCT01783145|"~     The aim of this study is to develop and evaluate a shared care survivorship care plan (SCP)~     to follow-up patients with metastatic testicular cancer after completion of chemotherapy that~     resulted in complete remission.~   "
136302|NCT01783132|"~     To compare the clinical outcome (effectiveness) of single inhaled corticosteroid (ICS)~     controller treatment guided by exhaled NO measurement made at home with usual care asthma~     management with regard to asthma control (primary outcome), asthma-related quality of life,~     lung function, airway inflammation, medication use, and asthma events.~      To understand changes in patient behaviour triggered by daily FENO measurement at home, for~     example treatment adherence and voluntary allergen exposure.~   "
136303|NCT01783119|"~     The Ulcerative Colitis (UC) belongs to the group of diseases called Inflammatory Bowel~     Disease (IBD) which is characterized by a chronic ulceration of the colon. The conventional~     treatment can have adverse effects and does not guarantee effectiveness in some patients~     requiring aggressive therapy using adjuvant therapy Aloe vera has been shown to have a~     beneficial effect in different disease, and have an anti-inflammatory effect in UC patients.~     Objective: Measuring the effect of the consumption of 200 ml of aloe vera gel daily for a~     period of three months, in the degree of inflammation in patients with mild UC based on Mayo~     scale and quantification of IL-6 in the colonic mucosa.~   "
136304|NCT01783106|"~     There is growing evidence that Crohn's disease may be caused by replication of bacteria,~     perhaps particularly E. coli, within macrophages (a specialized sort of white blood cell).~     Laboratory studies show that a combination of antibiotics that can penetrate macrophages~     (such as ciprofloxacin and doxycycline) together with the anti-malarial drug~     hydroxychloroquine (which makes the contents of macrophage vesicles more alkaline and helps~     them to kill intracellular bacteria) is particularly effective at killing the E. coli within~     macrophages.~   "
136305|NCT01783093|"~     The purpose of this study is to evaluate patients with pulmonary hypertension and sickle cell~     disease who have had multiple echocardiograms. Previous studies have shown that an elevated~     tricuspid jet (TR) regurgitant velocity on echo in this population is a predictor of~     mortality. This initial data only examined an isolated TR jet velocity. It was presumed that~     the mortality was related to pulmonary hypertension.~      It is the aim of this study to retrospectively evaluate patients who have had multiple~     echocardiograms and to determine if patients who had either a normalization of their TR jet~     velocity on a subsequent echo or had no evidence of pulmonary hypertension on right heart~     catheterization had a similar mortality rate to those with persistently elevated TR jet~     velocity.~   "
136306|NCT01783080|"~     The investigators aimed to assess the ability of a modified version of Behavioral Activation~     for occupational and social improvement to produce change in: 1. social adjustment, 2. work~     functioning, 3. avoidance behavior and 4. behavioral activation.~   "
136307|NCT01783067|"~     Populations who consume non-fortified plant-based diets are at increased risk of iron and~     zinc deficiencies. The purpose of this randomized controlled study is to determine the~     absorption of iron and zinc from pearl millet biofortified with these two micronutrients.~     Forty children aged 2 years in Kanartaka, India are randomized to consume biofortified pearl~     millet (Group 1) or control pearl millet (Group 2) for two days. Quantities of zinc and iron~     absorbed are measured with established stable isotope extrinsic labeling techniques and~     analyses of duplicate diets.~   "
136308|NCT01783054|"~     This study is for adult patients with adenocarcinoma of the pancreas. The purpose of this~     research study is to evaluate the safety and effectiveness of the drugs Gemcitabine and~     Abraxane in the treatment of adenocarcinoma of the pancreas before surgery. Subjects will~     have screening tests to determine if he or she is eligible to participate in this study.~   "
139936|NCT01735708|"~     The purpose of this study is to determine whether participation in the study intervention,~     which involves collaboration between the study interventionist and the participant's primary~     care physician, will reduce symptoms of pain and depression in HIV+ patients.~   "
136309|NCT01783041|"~     Preterm infants are vulnerable to brain injury, nutritional deficiencies and poor early~     growth which places them at increased risk for developmental problems later in life. The~     micronutrient carnitine, which is present in breast milk and stored in the fetus late in~     pregnancy, has been shown to protect against brain injury in animal studies. Without~     supplementation, almost all preterm infants develop carnitine deficiency soon after birth.~     Thus it is important to determine if carnitine supplementation protects against brain injury~     and improves developmental outcomes in these vulnerable preterm infants. We hypothesize that~     preterm infants supplemented early with L-carnitine while receiving parenteral nutrition will~     not develop carnitine deficiency and will have improved growth in the first two weeks of life~     and higher scores on developmental tests when compared to control infants who did not receive~     carnitine.~   "
136310|NCT01783028|"~     This study tests the hypothesis that community health workers providing home visits to~     provide education and support for self-management of asthma, assessment of the home for~     environmental triggers, resources for asthma control, and assistance in effective~     communication with medical providers over the course of one year would reduce asthma~     morbidity, asthma-related urgent health care use and exposure to indoor asthma triggers among~     low income adults with not well controlled asthma.~   "
136311|NCT01783015|"~     The first 12 weeks of this study will compare the efficacy of etanercept 50 mg once-weekly to~     placebo in subjects with rheumatoid arthritis who have not responded well to infliximab or~     adalimumab plus methotrexate. This comparison will be performed for all subjects and~     separately for subjects who are anti-drug antibody positive for one of these medications.~     From week 12 to week 24, all subjects will receive etanercept 50 mg once-weekly. The effect~     of anti-drug antibody status on the efficacy of etanercept as well as the safety profile of~     etanercept in these subjects will also be evaluated throughout the study.~   "
136312|NCT01783002|"~     The overall sensitivity and specificity of 11C-MET PET/CT is superior to 18F-FDG PET/CT and~     conventional SPECT-CT for the detection of abnormal parathyroid glands.~   "
136313|NCT01782989|"~     This is a prospective, randomized study to evaluate the efficacy and safety of ORACEA® in the~     treatment of geographic atrophy due to dry age-related macular degeneration (AMD).~   "
136314|NCT01782976|"~     The goal of this clinical research study is to learn if cilengitide given in combination with~     bevacizumab can help to control glioblastoma. The safety of this drug combination will also~     be studied.~      Cilengitide is designed to block the flow of blood to cancer cells, which may help to slow or~     block the growth of cancer.~      Bevacizumab is designed to block the growth of new blood vessels, which may help to slow or~     block the growth of cancer.~   "
136315|NCT01782963|"~     This research study is a Phase II clinical trial. Phase II clinical trials test the~     effectiveness of an investigational combination of drugs. The purpose is to learn whether the~     combination of drugs works in treating a specific cancer. Investigational means that the~     combination of drugs is still being studied. It also means that research doctors are trying~     to find out more about it. Examples of what they want to learn about are the safest dose to~     use, the side effects it may cause, and if the combination of drugs works for treating~     different types of cancer.~   "
136316|NCT01782950|"~     Tuberculosis (TB) is a leading cause of death in HIV-infected individuals. There are~     insufficient data correlating concentrations of anti-TB drugs with treatment response. We~     hypothesize that sub-therapeutic concentrations of anti-TB drugs are associated with~     inadequate TB treatment response to Mycobacterium tuberculosis.~   "
136317|NCT01782937|"~     This study is an open-label, non-controlled study to evaluate the efficacy and safety of~     KHK4827 in subjects with pustular psoriasis (generalized) and psoriatic erythroderma.~     Pharmacokinetics of KHK4827 will also be assessed.~   "
136318|NCT01782924|"~     This study is designed to evaluate safety and efficacy of long-term exposure of KHK4827 in~     subjects with moderate to severe plaque psoriasis who have completed the preceding Study~     4827-002.~   "
136319|NCT01782911|"~     Polycystic ovary syndrome (PCOS) is characterized by enlarged ovaries, menstrual irregularity~     and hyperandrogenism and is the most common cause of oligoovulatory infertility. Insulin~     resistance with resulting hyperinsulinemia is also common among women with PCOS, along with~     increased risk for dyslipidemia, hypertension, diabetes and related cardiovascular~     consequences. Resveratrol is a natural polyphenol with anti-carcinogenic, anti-proliferative~     and pro-apoptotic properties, that has been shown to decrease proliferation and~     steroidogenesis in theca cells, emerging as a potential therapeutic agent in PCOS patients.~     However, little is known about its potential beneficial effect on oocyte quality as well as~     other reproductive outcomes, such as implantation an pregnancy rates. The present study~     evaluates effects of resveratrol on selected biochemical parameters and reproductive outcome~     among patients with PCOS who undergo in vitro fertilization (IVF).~   "
136320|NCT01782898|"~     Seventy percent of surgeries performed in the United States are done in an outpatient~     setting.Pain Control after ambulatory surgery is very challenging because patients do not~     have access to fast and potent intravenous medications Pain after ambulatory surgery is~     poorly controlled in the United States with up to seventy five percent of patients having~     moderate to severe pain after ambulatory procedures. Postoperative pain have been associated~     with serious morbidity, including myocardial infarction and pulmonary embolism.~      The use of intraoperative opioids can result in an exaggerated response to pain~     (hyperalgesia) and contribute to an exacerbation of pain after surgical procedures.Opioids~     are commonly given intraoperative, not in response to pain, but in response to hyperdynamic~     cardiovascular states. Esmolol is a short acting beta 1 antagonist that can be used to~     treat/prevent hyperdynamic states during surgery. More importantly, esmolol has been shown to~     have central antihyperalgesic effects that might contribute to a reduction in postoperative~     pain. It is therefore conceivable that the use of intraoperative esmolol instead of opioids~     to avoid hyperdynamic states during surgery can result in lower postoperative pain. Since~     postoperative pain can substantially affect postoperative quality of recovery, it is also~     conceivable that the use of intraoperative esmolol might result in an improved postoperative~     quality of recovery to surgical patients.~      The main objective of the current study is to examine the effect of intraoperative esmolol on~     postoperative quality of recovery. A secondary objective is to examine the effect of esmolol~     on postoperative pain.~      Significance: Postoperative pain after ambulatory surgery has been shown to be poorly managed~     in The United States. The goal of this study is to investigate if a change in the~     intraoperative pharmacologic management of patients undergoing ambulatory surgery can improve~     their postoperative quality of recovery and pain.~      The research question is; does the use of intraoperative esmolol improve postoperative~     quality of recovery after ambulatory surgery? Does the use of intraoperative esmolol improve~     postoperative pain after ambulatory surgery?~      The hypotheses of this study is; does the use of intraoperative esmolol improves~     postoperative quality of recovery after ambulatory surgery. The use of intraoperative esmolol~     reduces postoperative pain after ambulatory surgery.~   "
136324|NCT01782846|"~     Double-blind randomized study to compare the efficacy of two analgesic drugs(Ixprim®,~     Dafalgan-Codeine®) in the emergency unit.~      The efficacy (relief of pain) would be assessed 2 hours after administration of one of the~     two drugs in a patient presented to the emergency unit with a moderate pain (4 to 6 on pain~     assessment score).~   "
136325|NCT01782833|"~     This is a Post Marketing Observational Study of cilostazol (Pletaal® SR capsule). As this~     study is observational in nature to collect the safety data after administrating the Pletaal~     SR capsule, from baseline to 16 weeks.~   "
136326|NCT01782820|"~     The aim of the present study is to compare the time course of a neuromuscular block in~     patients receiving dexamethasone 8 mg in order to reduce postoperative nausea or vomiting~     several hours before surgery with patients receiving the drug immediately before induction of~     anaesthesia and patients without a dexamethasone prophylaxis. The primary end point is the~     time from start of injection of rocuronium until recovery to a train of four ratio (TOF~     ratio) of 0.9.~   "
136327|NCT01782807|"~     The impact of Hysterectomy with preservation of the ovaries on ovarian function has long been~     controversial. studies have shown conflicting data regarding ovarian function after simple~     Hysterectomy.~      In recent years, there is a growing evidence that Salpingectomy or Fimbriectomy may have~     preventive value reducing Ovarian and Primary Peritoneal carcinoma, but the safety and the~     consequences regarding ovarian function have yet to be established.~      The aim of this study is to evaluate ovarian function after Hysterectomy alone Vs.~     Hysterectomy combined with salpingectomy or fimbriectomy~   "
136328|NCT01782794|"~     The present study is conducted in order to assess the acceptability of Hepatitis B~     vaccination in French general population before and after reimbursement of the paediatric~     vaccine InfanrixHexa. Four measurements are planned, first before reimbursement and the~     others at year 1, 2 and 3 after reimbursement.~   "
136329|NCT01782781|"~     The aim of the study is to evaluate traditional analgesic therapy after abdominal~     hysterectomy with single infiltration of local anesthetics in the surgical area at the end of~     surgery.~   "
136330|NCT01782768|"~     Background: The efﬁciency of Neural respiratory drive (NRD)expressed by a ratio of~     ventilation to the diaphragm electromyogram (EMGdi) decreases in patients with COPD~     .Improving the neural respiratory drive efficiency of COPD will help to relieve the clinical~     symptom and make the patients feel comfort.Noninvasive positive pressure ventilation(NPPV)is~     a good treatment to AECOPD patients.It is unknown the effects of different mode of~     noninvasive positive pressure ventilation(NPPV) such as proportional assist ventilation (PAV)~     and pressure-support ventilation (PSV) on the efﬁciency of Neural drive of AECOPD and which~     mode benefit the patients more.~      Objective: To compare the short-term effects of mask pressure support ventilation (PSV) and~     proportional assist ventilation (PAV) on Neural respiratory drive in recovering patients of~     AECOPD~   "
136331|NCT01782755|"~     Probiotics are commercially available live bacteria thought to have health benefits when~     ingested. A literature review of probiotic studies in the intensive care unit (ICU) found~     that in patients who receive probiotics, there is a 25% reduction in lung infection, known as~     ventilator-associated pneumonia (VAP). There is also an 18% reduction in the chance of~     developing any infection in the ICU. However, the studies reviewed were small and not well~     done. Therefore, whether probiotics are really helpful or not is unclear. Before a large~     carefully performed study is done to evaluate the effects of probiotics in critically ill~     patients, a pilot trial is needed. The investigators plan to study the feasibility of such a~     trial in mechanically ventilated ICU patients in 11 ICUs in Ontario, investigating whether~     orally ingested L. rhamnosus GG (a common probiotic) prevents VAP and other infections. The 4~     goals of the pilot study will be to ensure that we can successfully enrol patients; follow~     the protocol faithfully; make sure patients don't receive additional probiotics, and estimate~     how much pneumonia exists in these patients. In a separate substudy, the investigators will~     evaluate the effects of probiotics on lower lung infiltration with potential harmful~     bacteria, stool bacteria, markers of immunity called cytokines, and markers of infection~     called endotoxin levels. The investigators plan to enroll 150 adults admitted to ICU and~     receiving mechanical ventilation. Following informed consent, patients will be randomized to~     either L. rhamnosus GG group or an identical placebo. Twice daily, patients will receive~     probiotics or placebo in a feeding tube. The investigators will record all infections and~     other important outcomes in the ICU. This study is very important in the ongoing search for~     more effective strategies to prevent serious infection during critical illness. Probiotics~     may be an easy-to-use, readily available, inexpensive approach to help future critically ill~     patients around the world.~   "
136332|NCT01782742|"~     Retinoid X receptors (RXR) are nuclear receptors that have been linked to numerous metabolic~     pathways relevant to Alzheimer's disease (AD) and Aβ (harmful protein) production and~     removal. The study drug bexarotene is an FDA approved anti-cancer agent but is not approved~     for use in Alzheimer's disease. Bexarotene acts as an RXR agonist that has reduced Aβ~     (harmful protein) in the brain in experimental models of Alzheimer's disease.~      This study aims to determine the safety and effect on abnormal proteins found in the brain~     (based on brain scans) of 300 mg of bexarotene administered for one month compared to~     placebo (inactive agent).~   "
136333|NCT01782729|"~     The purpose of this study is to evaluate the safety and efficacy of tacrolimus ointment in~     treating the signs and symptoms of moderate (medium level of seriousness) to severe (very~     serious, life threatening) atopic dermatitis (an intensely pruritic [itching], chronic~     [lasting a long time], inflammatory [pain and swelling], immunologically based skin disease~     with a genetic predisposition [latent susceptibility to disease at the genetic level]) in~     pediatric participants.~   "
136334|NCT01782716|"~     Precise risk estimation of mortality in cardiac surgery patients is often difficult. Main~     objectives of this study is to calculate mortality probability by two different risk score~     system and to inquire effects of informing anesthesiologist and surgical team; of score of~     the patient; on length of hospitalization and intensive care and also on actualized~     mortality.~   "
136335|NCT01782703|"~     Atopic dermatitis (AD), also known as eczema, is the most common inflammatory skin disorder~     of children, affecting 10-20% of children and 1-2% of adults.~      This skin disorder can be associated with unbearable itchiness and an increased~     susceptibility to skin infections. The cause of AD is currently poorly understood; therefore,~     there are no targeted treatment options at present. There have been recent studies in adults~     with AD that explain the cause and give us new routes to investigate treatment options,~     however no major studies in this arena have been done in children. We hope to evaluate the~     skin and blood biomarkers that are found in pediatric AD and compare them to adult AD.~      Hypothesis: The immune system worsens the skin barrier issues that are common in atopic~     dermatitis. We believe there are similar immune and skin abnormalities in adult versus~     pediatric atopic dermatitis. Finally, blood levels of the activated molecules in atopic~     dermatitis can serve as surrogates for skin immune activation and will correlate with disease~     severity.~   "
136336|NCT01782690|"~     This observational study will evaluate the impact of rash on survival of patients with~     metastatic pancreatic cancer treated with Tarceva (erlotinib) plus gemcitabine. Further,~     clinical effectiveness, efficacy and safety will be assessed. Data will be collected for 12~     months.~   "
136337|NCT01782677|"~     The primary aim of the study is to determine safety, tolerability and feasibility of~     bilateral carotid body resection in patients with systolic heart failure and peripheral~     chemoreceptor hypersensitivity. The secondary aim is to assess potential efficacy of~     bilateral carotid body resection.~   "
136338|NCT01782664|"~     A multi-centre, randomised, dose ranging study to evaluate the safety and clinical efficacy~     of GSK2586184 in patients with chronic plaque psoriasis.~      There will be 2 study cohorts (Cohorts A and B). Cohort A is the main study cohort, and this~     part of the study will be randomised, double-blind and placebo-controlled. Fifty-six subjects~     will be randomised in Cohort A: 14 subjects in each treatment group: 100 mg, 200 mg or 400 mg~     GSK2586184, or placebo. Cohort B is an exploratory, open-label investigation of the effect of~     400 mg GSK2586184 on inflammatory gene expression in the skin and whole blood, and GSK2586184~     concentrations in the skin. A maximum of 8 subjects will be included, and all subjects will~     take 400 mg GSK2586184.~      In both Cohorts A and B, study medication will be administered orally (as tablets), twice~     daily, for up to 12 weeks.~      Each subject will have 7 out-patient visits: Screening; Baseline & Start of treatment; Week~     2; Week 4; Week 8; Week 12; and Follow-up (Week 16)~   "
136339|NCT01782651|"~     This study will describe the treatment paradigm used over recent years in the clinical~     management of Human Epidermal Growth Factor Receptor 2 (HER2)+ metastatic breast cancer in~     Hungary. This information will provide insight into real-world exposure and adherence to~     anti-HER2 therapy containing regimens, and improve understanding of the reasons for~     discontinuation of this therapy.~      This is a retrospective, descriptive, cohort study of approximately 180 female patients~     diagnosed with HER2-positive metastatic breast cancer in Hungary. Patients diagnosed with, or~     who progressed to, metastatic disease between 01 September 2009 and 01 September 2010 will be~     included. All patients will be followed until death, loss to follow-up or the end of the~     study period (30 September 2012). All data will be collected retrospectively from patient~     medical records.~      Descriptive statistics of the demographic and clinical characteristics of HER2+ metastatic~     breast cancer patients, including sites of metastases, the time from initial breast cancer~     diagnosis until diagnosis of metastatic disease, and HER2 testing methodology and status of~     HER2 will be described. Further, descriptive statistics of the proportion of HER2+ metastatic~     breast cancer patients who received anti-HER2 therapy, the sequencing of different therapies,~     and the duration of therapies in the metastatic setting will be analysed. Among the subset of~     women who receive lapatinib plus capecitabine, descriptive statistics of the timing of~     initiation of lapatinib plus capecitabine in the metastatic treatment pathway, time to~     treatment discontinuation and time to progression (TTP) on lapatinib plus capecitabine will~     be calculated. Further, descriptive statistics of the type and duration anti-HER2 therapies~     used prior to initiation of lapatinib plus capecitabine and, where relevant, after~     lapatinib+capecitabine will be performed.~   "
136340|NCT01782638|"~     Deep brain stimulation of STN (subthalamic nucleus) at high frequencies generally improved~     gait in parkinsonian patients. However, sometimes the investigators observed a gait~     aggravation either with using high voltage and high frequencies, either because of suboptimal~     placement of electrode inside Forel H2 field. The most frequent hypothesise to explain this~     gait aggravation is a modulation of the activity of pedunculopontine nucleus due to a~     diffusion of the electric stimulation current to the fibbers going near STN area.~      The primary purpose of this study is to compare the effect of deep brain stimulation with~     high frequency versus low frequency on gait of patients whatever the electrodes placement~     (STN ou Forel fields) and whatever the medication condition (with or without treatment).~   "
136341|NCT01782625|"~     The investigators will simulate the conditions of a working, helmeted diver by using~     exercising, head out immersed subjects to test the following hypotheses:~        1. An algorithm can be developed which predicts cognitive performance in immersed~          exercising divers, based on the exhaled carbon dioxide (PETCO2) and the diver's inspired~          partial pressures of oxygen and nitrogen (PIO2 and PIN2).~        2. PETCO2 using mass spectrometry is an accurate estimate of arterial carbon dioxide~          (PaCO2) at rest and during immersed exercise and can be used as a PaCO2 surrogate at~          levels exceeding 50 mmHg and depths up to 158 fsw (gas density 6.4 g/l, similar to 165~          fsw density of 6.8 g/l).~   "
136342|NCT01782612|"~     Postoperative recovery is always worrisome to the elder patients undergoing Total Hip~     Replacement (THR). Peripheral Nerve Blocks (PNBs), lumbar plexus block combined with sciatic~     nerve blocks, may be alterative anaesthesia style to the fragile patients. But pervious~     papers suggested PNBs were commonly administered in conjunction with general anesthesia (GA),~     or the blocks were performed primarily for postoperative analgesia. Hardly any research has~     reported in use of Peripheral Nerve Blocks (PNBs) as primary anesthesia style for Total Hip~     Replacement (THR). The investigators compare peripheral nerve blocks to general anesthesia on~     elderly eld patients undergoing Total Hip Replacement (THR) by assessing the Postoperative~     Recovery and Delirium~   "
136343|NCT01782599|"~     The purpose of this study is to determine whether electronic cigarettes can reduce reactivity~     to smoking-related cues.~   "
136344|NCT01782586|"~     The purpose of this study is to determine if certain genes found in a kidney biopsy performed~     at one-year post transplant can predict which transplanted kidneys will have decreased kidney~     function within five years post-transplant.~   "
136345|NCT01782573|"~     To test whether pre - disinfection skin scrub with 4% chlorhexidine gluconate is more~     effective on the reduction of surgical site microbial colonization and subsequent infection~     than is normal saline.~   "
136346|NCT01782560|"~     Noisy breathing is commonly caused by a floppy voicebox which is a condition called~     laryngomalacia. The cause of laryngomalacia is not fully understood, but some studies have~     suggested that it could be due to acid escaping from the stomach and spreading up the~     swallowing passage to the throat (acid reflux). This affects about 1 in 100 newborns and is~     therefore one of the most common reasons for infants to see Otolaryngologists at BC~     Children's Hospital (BCCH). These infants can have a spectrum of distressing symptoms~     including squeaky breathing, choking, difficulty feeding, failure to gain weight, and~     episodes of turning blue (due to lack of oxygen).~      At present, Otolaryngologists at BCCH will sometimes give children with laryngomalacia~     medication to reduce the amount of acid they make in their stomachs, in the hope that this~     will reduce their symptoms of laryngomalacia. It has never been scientifically confirmed~     whether anti-reflux medication will benefit these children any more than doing nothing at~     all.~   "
136347|NCT01782547|"~     Hospitalization of youth with established diabetes is both costly and frequently preventable.~     Poor glycemic control is a risk factor for hospitalization and is also associated with~     adolescent age and lower socioeconomic status. This is a randomized, controlled trial for~     high-risk adolescent youth with T1DM and suboptimal glycemic control with an intervention arm~     and usual care control arm matched for frequency of contacts. There will be 110 subjects with~     T1DM and HbA1c>8%, aged 13 to 17 years, recruited from the Diabetes Program at Boston~     Children's Hospital and followed for 6 months. The intervention will be implemented by a~     diabetes nurse educator and social worker, who will each have monthly contact with the~     adolescent and a parent/guardian through a telehealth (videoconference) visit. Care will be~     guided by a diabetes action plan. Telehealth interventions have been utilized successfully in~     both adults and youth with diabetes. They facilitate frequent contact with the care team~     allowing barriers to adherence to be addressed, education to be reinforced, care plans to be~     updated, and diabetes-specific family support to be provided.~   "
136349|NCT01782521|"~     Orthodontic treatment is carried out by placing fixed attachments(brackets)on teeth with~     wires which run through them and create tooth movement. These metal brackets are bonded~     (glued) onto the tooth surface by a three step process. Firstly, a mild acid is used to~     roughen the tooth surface, secondly a free flowing glue (composite primer) is used to fill in~     the roughened pores and thirdly, the bracket is glued on to the tooth surface with a~     'composite' material which sets hard by exposure to a high intensity light.The success of~     this procedure is measured by bracket failure rates.~      The literature review suggests that the scientific evidence is not clear to indicate whether~     the use of a primer is absolutely essential to achieve acceptable bracket success rates in a~     clinical environment.~      The primary aim of the study is to find out if the rate of loss of orthodontic brackets is~     clinically acceptable when they are glued onto the tooth surface without the use of a primer~     as compared to brackets bonded with a primer over a 12 month study period. The investigators~     will also investigate the Bonding time,Type of bracket bond failure,length of treatment and~     Peer Assessment Rating scores (PAR)~      This RCT will be undertaken on consented NHS patients in 3 hospitals in Yorkshire region by~     multiple operators~      The results from this study will help improve our knowledge of the best approach to bonding~     metal brackets on teeth. If the bracket failure rate is similar in both groups, this would~     indicate that the use of a primer is not always necessary. For patients, this would mean~     lesser time required to place brackets at the start of orthodontic treatment. For clinicians~     and NHS purchasers the outcome will influence cost effectiveness (as the primer is the most~     expensive component in the bonding process) and provide a framework for future studies.~   "
136350|NCT01782508|"~     The purpose of this study is to compare the relapse free survival and overall survival of~     Imatinib (Gleevec) or high dose Interferon (Intron) in treating melanoma which has primary~     tumor and regional lymphonode (if have) removed in patients whose disease carries a c-kit~     mutation. It is assumed that Gleevec may be more effective on relapse free survival as the~     adjuvant treatment compared with Interferon.~   "
136351|NCT01782495|"~     The purpose of this study is to evaluate the safety and efficacy of ABT-450/r/ABT-267 with or~     without ABT-333 and with or without ribavirin (RBV) in adult liver or renal transplant~     recipients with hepatitis C virus (HCV) genotype 1 or 4 (GT1 or GT4) infection.~   "
136352|NCT01782482|"~     The purpose of this study was to evaluate overall satisfaction with AIR OPTIX® COLORS as~     compared to FRESHLOOK® COLORBLENDS contact lenses.~   "
136353|NCT01782469|"~     This Post-Marketing Observational Study (PMOS) was conducted to assess the effectiveness of~     adalimumab on reducing synovitis (inflammation of the synovial membrane, which lines movable~     synovial joints, such as shoulders, elbows, wrists, knees, and hips) in adult participants~     with Rheumatoid Arthritis (RA) in Egypt. B-mode ultrasonography data was collected from~     participants receiving adalimumab treatment who had not been treated with any other~     anti-tumor necrosis factor (anti-TNF) therapy in the past.~   "
136354|NCT01782456|"~     The objective of this study is to capture information on gastrointestinal tolerance (GI) of~     an oral nutritional supplement containing a new protein blend in healthy children aged ≥ 3 to~     ≤ 10 years.~   "
136355|NCT01782443|"~     This research study is a Phase II clinical trial, which tests the safety and effectiveness of~     an investigational drug to learn whether the drug works in treating a specific cancer.~     Investigational means that the drug, Ziv-aflibercept, is being studied. It also means that~     the FDA has not yet approved Ziv-aflibercept for use in patients with your type of cancer.~      Every person has molecules in their bloodstream called vascular endothelial growth factors~     (VEGFs). These molecules help grow and sustain new blood vessels needed by the human body.~     Cancer tumors hijack this mechanism because they need new blod vessels and oxygen to grow.~     Ziv-aflibercept is an antibody. Antibodies are proteins that are produced naturally in our~     bodies and help to recognize foreign substances in our body. Ziv-aflibercept is a targeted~     therapy called a VEGF Trap, that traps (binds) these VEGFs and prevents the cancer from~     using them to grow.~      Though Ziv-aflibercept has not yet been FDA approved for the treatment of carcinoid tumors,~     it has recently been approved for patients with treatment-resistant colorectal cancer.~      In this research study, we will use Ziv-aflibercept in combination with standard octreotide~     therapy to see if it slows the growth or spread of your carcinoid tumor. Standard octreotide~     (sandostatin) therapy is currently approved for treating symptoms of carcinoid tumors, such~     as those caused by carcinoid syndrome. Carcinoid syndrome is caused by hormones and other~     substances released by carcinoid tumors into the bloodstream. One of these secreted~     substances is serotonin, one of the body's natural chemical messengers. When excess serotonin~     secreted by the carcinoid tumors reaches the body's tissues, it is thought to cause diarrhea~     and redness (flushing) of the face, chest or back. Excess serotonin may also cause changes in~     the structure of the heart valves, which can impair the heart's function. Octreotide works by~     binding to receptors found on carcinoid tumors and prevents the release of hormones from the~     tumor.~   "
136356|NCT01782430|"~     Prospective, randomized clinical multicentric study, in ICU, during preoxygenation for the~     intubation of hypoxemic patients.~   "
136357|NCT01782417|"~     Hispanics are affected by arthritis at a slightly lower age-adjusted rate compared to~     non-Hispanic whites and African Americans. However, compared to other groups, Hispanics have~     a higher prevalence of arthritis-attributed activity limitations (primarily related to OA),~     are less likely to receive hip replacement independent of health care access, and are less~     likely to receive knee replacement. The study is conducted to develop and test a telephone~     delivered intervention for the management of OA in Hispanic adults. This study is conducted~     as a minority supplement to the Patient and Provider Interventions for Managing~     Osteoarthritis in Primary Care (PRIMO) NCT01435109 and Pro00022836.~   "
136358|NCT01782404|"~     This a prospective, non-controlled, open, multi-center study evaluating the reduction of~     bacteriuria after bladder irrigation with chlorhexidine in spinal cord injured patients with~     chronic bacteriuria practicing intermittent catheterisation (IC). Patients will be treated~     with chlorhexidine for bladder irrigation twice daily for a maximum of 7 days.~      The study hypothesis is that bladder irrigation with chlorhexidine is efficient for a short~     term reduction of bacteriuria in patients performing intermittent catheterization (IC).~   "
136359|NCT01782391|"~     The beneficial effect of nocturnal sleep on memory consolidation is well-documented in young,~     healthy subjects. Especially, periods rich in slow-wave sleep (SWS) have shown a memory~     enhancing effect on hippocampus-dependent declarative memory. Slow oscillatory activity~     typically occuring during SWS has been implicated in the consolidation effect. Recent~     evidence in young healthy subjects suggest that the sleep-associated consolidation effect can~     be amplified by the application of a weak transcranial oscillatory electric current within~     the frequency range of SWS in humans (0,7-0,8 Hz) during SWS. If patients with amnestic mild~     cognitive impairments (MCI)- usually characterized by initial difficulties in hippocampus~     dependent memory functions - benefit from transcranial slow oscillatory stimulation (tSOS)~     during nocturnal sleep as well has not been studied so far. The primary aim of the present~     study is to investigate the influence of a weak slow oscillating brain stimulation (tSOS) on~     declarative memory consolidation applied during periods of nocturnal SWS in MCI patients.~   "
136380|NCT01782118|"~     Background: Proton pump inhibitors (PPI) are effective for treating gastroesophageal reflux~     disease (GERD). However, they may be associated with an increased risk of gastrointestinal~     and respiratory tract infections.~      Aim: To determine if Lactobacillus GG (LGG) is an effective adjunct to PPI for reducing the~     risk of gastrointestinal and respiratory tract infections in children with GERD.~      Study design: Randomized, double-blind, placebo controlled trial.~   "
136360|NCT01782378|"~     The purpose of this study is to learn if an experimental treatment can help thinking ability,~     and memory in Veterans with Gulf War Veterans Illnesses (GWVI). The experimental treatment~     uses light-emitting diodes (LEDs), that are applied outside the skull, to the head using a~     helmet that is lined with near-infrared diodes. LEDs are also placed in the nostrils (one red~     diode: and one near-infrared diode), to possibly deliver photons to the deeper parts of the~     brain. A treatment takes about 30 minutes. The participants receive a series of LED~     treatments which take place as outpatient visits at the VA Boston Healthcare System, Jamaica~     Plain Campus. The LEDs contain red and near-infrared diodes. The FDA considers the LED device~     used here, to be a non-significant risk device. The LEDs do not produce heat.~   "
136361|NCT01782365|"~     The beneficial effect of nocturnal as well as daytime sleep on memory consolidation is~     well-documented in young, healthy subjects. Slow wave sleep (SWS), in particular, with its~     slow oscillating activity have shown to enhance declarative, hippocampus-dependent memory~     representations. This impact of sleep on memory performance can be additionally enhanced by~     exogeneous induction of transcranial slow oscillating stimulation (tSOS) within the frequency~     range of SWS in humans (0,7- 0,8 Hz) during sleep, as has been demonstrated in young, healthy~     subjects. If patients with amnestic mild cognitive impairment (MCI)- usually characterized by~     initial difficulties in hippocampus dependent memory functions - benefit from transcranial~     slow oscillatory stimulation (tSOS) during sleep as well has not been studied so far. The~     primary goal of the study is therefore to investigate the impact of oscillating current~     stimulation (tSOS) during a daytime nap on declarative memory consolidation in MCI patients.~   "
136362|NCT01782352|"~     The VITamin D and OmegA-3 Trial (VITAL; NCT 01169259) is a randomized clinical trial in~     25,875 U.S. men and women investigating whether taking daily dietary supplements of vitamin~     D3 (2000 IU) or omega-3 fatty acids (Omacor fish oil, 1 gram) reduces the risk of developing~     cancer, heart disease, and stroke in people who do not have a prior history of these~     illnesses. This ancillary study is being conducted among participants in VITAL and will~     examine whether vitamin D or omega-3 fatty acids, compared to placebo, reduce the incidence~     and/or progression of age-related macular degeneration (AMD).~   "
136363|NCT01782339|"~     The treatment of germ cell tumours is considered to be one of the major successes in the area~     of cytotoxic chemotherapy. Even in patients who relapse after first line therapy, a durable~     remission rate of between 25% and 60% has been seen using further chemotherapy. In 1999,~     researchers at St Bartholomew's Hospital developed the GAMEC protocol (combination~     chemotherapy with filgrastim, actinomycin D, methotrexate, etoposide, cisplatin). Results~     from this study showed that 50% of patients with relapsed testicular cancer could be cured~     using this treatment. When we reviewed the individual patients it was clear that older~     patients (>35yrs) or patients with a raised Lactate Dehydrogenase (a blood test that monitors~     cancer activity), did not do as well. In addition, patients whose original tumour started in~     their chest (mediastinal germ cell tumour) have tended to do badly if they relapse. We have~     been developing a study for patients who fulfil at least one of these criteria. The GAMIO~     study (filgrastim, actinomycin D, methotrexate, irinotecan, oxaliplatin) has recently closed~     due to problems with high levels of toxicity from the irinotecan. GAMMA is a new study that~     will use paclitaxel instead of irinotecan and oxaliplatin instead of cisplatin. We expect~     that this treatment with oxaliplatin will be less damaging to the kidneys than cisplatin.~     Both oxaliplatin and paclitaxel and oxaliplatin and irinotecan have similar activity in~     relapsed patients in the phase II setting. We hope to improve on our previous results with~     this substitution and see if this will lead to an improvement in the cure rate of relapsed~     germ cell tumours with poor prognosis and reduce the side effects compared to our standard~     treatment. In addition, we do not expect any hearing damage and the treatment requires a~     shorter hospital stay.~   "
136364|NCT01782326|"~     This study will assess the efficacy, safety and tolerability of QVA149 in patients with~     moderate to very severe COPD.~   "
136365|NCT01782313|"~     This study is for patients who have been diagnosed with soft tissue sarcoma that has spread~     (metastasized) or that is not eligible for removal by surgery. The purpose of this study is~     to determine how soft tissue sarcomas respond to treatment with an investigational drug~     called tivozanib. In some lab and clinical studies, tivozanib has been shown to interfere~     with the growth of some types of tumors. The study will also evaluate how safe the study~     treatment is by observing how many and what kind of adverse events (side effects)~     participants experience.~   "
136366|NCT01782300|"~     Dengue viruses can cause dengue fever and other more severe forms of disease. This study will~     evaluate the safety and immune response to two doses of a dengue virus vaccine given 12~     months apart in healthy adults.~   "
136367|NCT01782287|"~     Trial Hypothesis: Acute, progressing lethal neurooncological process can be transferred into~     chronic and non-lethal, the survival rates and life quality can be improved by of control of~     tumor cells (TCs) quantity and targeted regulation of effector functions of tumor stem cells~     (TSCs).~      Brief Description:~      The first line therapy of brain metastases of lung cancer (BMLC) involves allogeneic~     haploidentical hematopoietic stem cells (HSCs), dendritic vaccine (DV) and cytotoxic~     lymphocytes (CTLs).~      TCs and TSCs are isolated from BMLC sample. Dendritic cells are isolated from peripheral~     blood mononuclear cells and cultured. Tumor sample provides tumor specific antigens to~     prepare DV. CTLs are obtained from peripheral blood after DV administrations. HSCs are~     harvested from closely related donor after granulocyte-colony-stimulating factor (G-CSF)~     administration.~      Allogeneic HSCs are administered intrathecally 5 times every 2 weeks, at day 1, 14, 28, 42,~     56. DV is given 3 times every 2 weeks (day 14, 28, 42) subcutaneously in four points. CTLs~     are administered every 2 weeks for 3 months, then 3 times every 1 month intrathecally. Six~     months after the therapy completion, the efficiency is evaluated and the cohort demonstrating~     efficiency continues the therapy, while cohort demonstrating no efficiency is transferred to~     active comparator arm.~      Second line therapy involves DV with recombinant proteins, CTLs and autologous HSC with~     modified proteome. Autologous HSCs are mobilized by G-CSF.~      Carcinogenesis-free intracellular pathways of signal transduction able to respond to targeted~     regulation of therapeutic cell systems with specific properties, are detected in TSCs using~     complete transcriptome profiling of gene expression, proteome mapping and profiling of~     proteins, bioinformation and mathematical analysis and mathematical modeling of protein~     profiles. To find key oncospecific proteins in TSCs and TCs, the targets for TSCs regulation~     are detected, as well as protein ligands able to regulate reproductive and proliferative~     properties of TSCs.~      Using these data of TCs and TSCs proteins, the cell preparations to initiate adoptive immune~     response are prepared: DV loaded with recombinant proteins analogous to key tumor antigens,~     CTLs and autologous proteome-based HSCs.~      Autologous proteome-modified HSCs, DV and CTLs are administered as in the first line therapy.~   "
136417|NCT01781637|"~     The investigators will perform a double blind, placebo controlled clinical trial with Xolair~     (omalizumab) at four centers to safely and rapidly desensitize patients with severe peanut~     allergy. The investigators will determine if pretreatment with anti-IgE mAb~     (Xolair/omalizumab) can greatly reduce allergic reactions and allow for faster and safer~     desensitization.~   "
136368|NCT01782274|"~     Trial Hypothesis: Acute, progressing lethal neurooncological process can be transferred into~     chronic and non-lethal, the survival rates and life quality can be improved by of control of~     tumor cells (TCs) quantity and targeted regulation of effector functions of tumor stem cells~     (TSCs).~      Brief Description:~      The first line therapy of brain metastases of breast cancer (BMBC) involves allogeneic~     haploidentical hematopoietic stem cells (HSCs), dendritic vaccine (DV) and cytotoxic~     lymphocytes (CTLs).~      TCs and TSCs are isolated from BMBC sample. Dendritic cells are isolated from peripheral~     blood mononuclear cells and cultured. Tumor sample provides tumor specific antigens to~     prepare DV. CTLs are obtained from peripheral blood after DV administrations. HSCs are~     harvested from closely related donor after granulocyte-colony-stimulating factor (G-CSF)~     administration.~      Allogeneic HSCs are administered intrathecally 5 times every 2 weeks, at day 1, 14, 28, 42,~     56. DV is given 3 times every 2 weeks (day 14, 28, 42) subcutaneously in four points. CTLs~     are administered every 2 weeks for 3 months, then 3 times every 1 month intrathecally. Six~     months after the therapy completion, the efficiency is evaluated and the cohort demonstrating~     efficiency continues the therapy, while cohort demonstrating no efficiency is transferred to~     active comparator arm.~      Second line therapy involves DV with recombinant proteins, CTLs and autologous HSC with~     modified proteome. Autologous HSCs are mobilized by G-CSF.~      Carcinogenesis-free intracellular pathways of signal transduction able to respond to targeted~     regulation of therapeutic cell systems with specific properties, are detected in TSCs using~     complete transcriptome profiling of gene expression, proteome mapping and profiling of~     proteins, bioinformation and mathematical analysis and mathematical modeling of protein~     profiles. To find key oncospecific proteins in TSCs and TCs, the targets for TSCs regulation~     are detected, as well as protein ligands able to regulate reproductive and proliferative~     properties of TSCs.~      Using these data of TCs and TSCs proteins, the cell preparations to initiate adoptive immune~     response are prepared: DV loaded with recombinant proteins analogous to key tumor antigens,~     CTLs and autologous proteome-based HSCs.~      Autologous HSCs, DV and CTLs are administered as in the first line therapy.~   "
136369|NCT01782261|"~     Assessment of the effect of incretin based therapies (Liraglutide and Saxagliptin) on immune~     cells in healthy subjects and patients with type 1 diabetes~   "
136370|NCT01782248|"~     The aim of this study is to characterize the deficit in critical components of personal~     identity (self-consciousness and social cognition) in patients with Alzheimer's disease (AD)~     and fronto-temporal lobar dementia (FTLD), compared to healthy elderly, combining a~     neuropsychology and multi-podal neuroimaging study.~      We posit that the alteration of some aspects of self-consciousness (autobiographical memory,~     nosognosia, metacognition) and social cognition (theory of mind and facial) results in~     personality changes in the patients, primarily due to the alteration of self-consciousness in~     AD and to social cognition in FTLD.~   "
136371|NCT01782235|"~     Primary Sjögren's syndrome (pSS) is a systemic autoimmune disease characterized by~     lymphocytic infiltration leading to destruction of acinar and ductal cells and loss of~     glandular parenchyma. The main symptoms of pSS are dry eyes and dry mouth, diffuse pain, and~     fatigue. One third of patients develop systemic features, the most severe being lymphomas.~      Serum IL-6 is increased in serum, saliva, and tears of patients with pSS. IL-6 plays a~     pivotal role in B-cell activation, a hallmark of the pathogenesis of pSS, and in T-cell~     differentiation. Tocilizumab, a recombinant humanised monoclonal antibody acts as an IL-6R~     antagonist. The aim of this randomised double blind placebo controlled trial iss to evaluate~     the efficacy of tocilizumab for the treatment of pSS.~   "
136372|NCT01782222|"~     This trial is being conducted to assess the effects of Rotigotine over Placebo on improvement~     of Apathy and motor symptoms in subjects with early-stage and advanced stage idiopathic~     Parkinson´s Disease.~   "
136373|NCT01782209|"~     The objectives of this study is to establish the natural history of BK virus viremia and~     other possible opportunistic viral pathogens in renal transplants receipients.~   "
136374|NCT01782196|"~     Certain research and innovation projects require an assessment of the adhesive properties of~     adhesives, which cannot be established from in-vitro testing. The most valuable data for~     assessments of this type comes from adhesion and wear time studies involving application to~     living human skin on volunteers. The purpose of the study is to assess the safety and~     performance of an enhanced one piece drainable pouch with a mouldable skin barrier wafer in a~     group of subjects with an ileostomy.~   "
136375|NCT01782183|"~     Thermographic cameras are used to determine temperature and temperature differences. Attempts~     have been made to use the thermographic camera as a diagnostic tool in clinical practice.~     Thermographic cameras have been approved by the FDA in the diagnosis of breast cancer. The~     camera absorbs infrared radiation which is discharged from the tissue and than translates it~     to a digital data or a photograph. The camera does not radiate and direct contact with the~     patient is not needed. The safety is similar to a regular optic camera. No study on~     thermographic characteristics of inflammation of organs has been published. The purpose of~     this study is to demonstrate and document these characteristics of inflammation. The~     correlation between the thermographic imaging and the clinical diagnosis, using routine~     methods, will be analyzed. The differences of thermographic imaging between an inflamed organ~     of a subject to a non inflamed same organ of a normal control will also be analyzed. The~     management of the patient will be by standard practice and will not be influenced by the~     thermographic camera image and the study outcome.~   "
136376|NCT01782170|"~     The purpose of this study is to explore the efficacy of Iocide oral rinse in a human clinical~     trial of gingivitis. Iocide oral rinse will be evaluated against a placebo rinse. Indices for~     gingivitis, plaque and bleeding will be scored and blood tests will be performed to determine~     the effect of the antimicrobial oral rinse on relative levels of biological markers of~     inflammation.~   "
136377|NCT01782157|"~     The world's population is aging and the resulting prevalence of chronic illnesses is a~     challenge that our society must address. The vision is to address this challenge by designing~     smart environment technologies that keep older adults functioning independently in their own~     homes as long as possible. Smart environments have been used as the basis of monitoring~     activities for residents with health conditions. However, there is currently a lack of large~     scale, longitudinal research to identify early markers of dementia and other health status~     changes and to predict functional decline. The objective of this project is to perform a~     5-year longitudinal study of older adults performing daily activities in their own smart~     homes.~   "
136378|NCT01782144|"~     Obesity is a serious medical, social, and economic problem and is becoming even greater~     concern, as the prevalence of overweight and obese individuals has steadily increased over~     the years. Excessive body weight can have a profound influence on lower extremities,~     including pain, degenerative disease, and compromised quality of life. However, no study~     to-date has examined the effects of weight change on foot structure and function in~     individuals over time. The purpose of this study is to determine the effects of weight~     reduction on foot structure and function in obese adults. Improved understanding of the~     relationship between body weight and foot biomechanics is needed to promote health and~     healthier lifestyles.~   "
136381|NCT01782105|"~     The purpose of this study are:~        -  Assess the impact of an intervention to the adoption of healthy lifestyles among~          pregnant women at high risk of gestational diabetes mellitus on:~             -  weight gain in pregnancy~             -  the levels of maternal and fetal adipokines and~             -  glycemic control maternal and fetal.~        -  Determine whether the adoption of healthy lifestyles in pregnancy is associated with~          epigenetic changes that influence the levels of adipokines and glucose regulation during~          pregnancy and in newborns.~   "
136382|NCT01782092|"~     The purpose of this study (15-subject prospective case series) is to examine the effects of~     the Activator Methods technique on decreasing A1c levels in patients with type II Diabetes~     Mellitus (aka adult-onset diabetes).~   "
136383|NCT01782079|"~     The aim of this study is to select the optimal conditions for quantification in the oral~     cavity of Lactobacillus brevis CD2, a probiotic strain contained in a commercially available~     dietary supplement and to assess its persistency after oral administration. Different sets of~     primers for L. brevis detection will be tested in real-time PCR reactions to find optimal~     amplification efficiency and target specificity. Primers ability in the identification of L.~     brevis DNA will be assessed in a pilot study conducted on 12 healthy volunteers clinically~     free of oral pathologies. The subjects will take 3 tablets/day for 3 days and one tablet on~     the 4th day. Clinical samples (dorsal surface of tongue, first molar, vestibular fornix and~     saliva) will be collected at baseline (before beginning the trial), at T0 (in the morning~     before the assumption of the last tablet) and 3, 6, and 9 hours after taking the last tablet.~     The quantities of L. brevis DNA will be compared to the total number of bacteria present in~     the samples. The activity of the enzyme arginine deiminase, responsible for oral pH~     homeostasis (particularly abundant in the CD2 strain) will be also assessed in the saliva~     samples before and after treatment, by HPLC measurements.~   "
136384|NCT01782066|"~     Invasive meningococcal disease is a worldwide problem with serious repercussions for those~     affected. Vaccination is recognized as the best way to combat it. The cost of vaccination is~     prohibitive in many low-resource settings at home and abroad. By harnessing the special~     immunologic properties of the skin, a dose reduction may be achieved by intradermal~     administration of the vaccine. The cost savings associated with dose reduction will increase~     availability of the vaccine.~   "
136385|NCT01782053|"~     Smoking is the largest preventable health risk in the U.S. The Family Smoking Prevention and~     Tobacco Control Act of 2010 mandated the placement of larger pictorial warnings on cigarette~     packs as well as nine new statements of smoking risks. This trial tests the effectiveness of~     the warnings proposed by the Food and Drug Administration by providing cigarettes with the~     proposed labels to 320 smokers across two sites (Philadelphia, PA and Columbus, OH). In~     addition, the trial tests the effects of different warning label components.~   "
136386|NCT01782040|"~     Premenstrual syndrome (PMS) is a collection of physical and emotional symptoms related to a~     woman's menstrual cycle. These symptoms occurring only during the luteal phase of the~     menstrual cycle that are of sufficient severity to interfere with some aspects of life of~     these women, reflecting also in interpersonal relationships, workplace and in their~     productivity. For these reasons, this research was conducted with the nursing staff of the~     Samaritan Hospital in order to verify the effectiveness of auricular acupuncture to alleviate~     some of the symptoms of PMS.~   "
136387|NCT01782027|"~     The purpose of this study is to investigate the use of radiolabeled particulate cholesterol~     administered intravenously in association with albumin, as a method to study reverse~     cholesterol transport (RCT) in people carrying mutations in genes known to affect high~     density lipoprotein (HDL) metabolism by analyzing changes in the tracer activity in total~     plasma, lipoproteins fractions and feces.~   "
136388|NCT01782014|"~     The purpose of this study is to determine which of the methods of colonoscopy viz. water~     insufflation or air insufflation or carbon dioxide insufflation is better in detecting the~     adenomas in colon and also which of these methods is best tolerated by patients.~      Hypothesis: the investigators hypothesize that in patients undergoing first time screening~     colonoscopy a higher Adenoma Detection Rate will be found in the proximal colon in the group~     randomized to the water method compared to those randomized to the air or CO2 insufflation~     methods~   "
136389|NCT01782001|"~     The purpose of this study was to determine whether young children receiving Vitamin A and~     Zinc supplements will have a lower incidence of symptomatic malaria than similar children~     receiving vitamin A supplements alone.~   "
136390|NCT01781988|"~     Excision repair cross complementing 1 (ERCC1) ribonucleotide reductase M1 (RRM1) and~     thymidylate synthase(TS) are molecular determinants that predict sensitivity or resistance to~     platinum agents 、 gemcitabine and pemetrexed respectively.~      Tailored therapy using these molecular determinants suggested patient benefit in a previously~     reported phase 2 trial. Here, we designed a study for an individual patient analysis of~     prospectively accrued patients who were treated with the personalized therapy approach~     versus other standard approaches.~   "
136391|NCT01781975|"~     Type 1 diabetes mellitus (T1DM) results from the autoimmune destruction of insulin-producing~     ß cells. Although exogenous insulin is widely available, it is not possible for affected~     individuals to consistently achieve euglycemia with current technology, and thus they are at~     risk for devastating long-term complications. This phase II study is designed to evaluate the~     safety and efficacy of imatinib mesylate as a novel therapy for new-onset T1DM. Imatinib is a~     first-in-class tyrosine kinase inhibitor.~      This study will explore the potential role of short-term therapy with imatinib to induce~     tolerance and possibly lead to a durable long-term remission of T1DM.~   "
136392|NCT01781962|"~     This study will assess angle width in Chinese patients with Open-angle Glaucoma and/or Ocular~     Hypertension.~   "
136393|NCT01781949|"~     The purpose of this study is to evaluate the effectiveness of 3 modern rapid HIV screening~     methods, including a novel targeted strategy, in urban emergency department settings in the~     United States.~   "
136418|NCT01781624|"~     The objective of this study is to evaluate gastrointestinal tolerance of an oral nutritional~     supplement containing a new protein blend in healthy elderly subjects.~   "
137280|NCT01770340|"~     Earlier studies were able to show that an improvement of the erectile function following a~     non-nerve sparing radical prostatectomy could be achieved using an autologous nerve graft.~      The investigators evaluate the use of the implantation of the allogenic nerve graft Avance®~     in patients undergoing non nerve-sparing radical prostatectomy.~   "
136394|NCT01781936|"~     The purpose of this study is to determine the tolerability, safety, and benefits of an~     investigational drug,Fluocinolone Acetonide Intravitreal Insert (FA-i), in people who have~     posterior uveitis. The study drug, Fluocinolone Acetonide, is currently used in a surgical~     implant, Retisert, which is approved by the U.S. Food and Drug Administration (FDA) to treat~     non-infectious posterior uveitis . The study drug is able to be inserted in an ophthalmology~     (eye) clinic; whereas Retisert must be surgically implanted in the Operating Room. Initially,~     this was a 2-dose randomized pilot study. However, the study was modified to include only the~     0.2 ug/day implant.~   "
136395|NCT01781923|"~     The goal of this study is to collect preliminary data on the efficacy of a cognitive~     remediation program in improving the neurocognitive deficits in children with chromosome~     22q11.2 deletion syndrome (22q11DS). This study involves a two part approaching including a~     computerized cognitive remediation program (CCRP, Posit Science, CA) in combination with a~     Social Cognitive Training (SCT) program. The computer-based training program has shown~     encouraging results in improving learning deficits in individuals with schizophrenia and we~     now seek to adapt them to children with 22q11DS, who have unique needs due to their lower IQ~     and high risk of psychosis in late adolescence and adulthood. The SCT is a small-group~     intervention program based on cognitive enhancement therapy, which has been shown to improve~     social cognition and functionality in adults with schizophrenia. A preliminary study will be~     performed using this two-pronged approach, to establish the feasibility and gather~     preliminary data on neurocognition before and after the intervention in these children; these~     data would enable a larger randomized controlled study to assess the efficacy of this~     approach.~   "
136396|NCT01781910|"~     The purpose of this study is to determine if a dietary supplement containing branched chain~     amino acids will reduce the muscle soreness that sometimes occurs in the days following~     exercise.~   "
136397|NCT01781897|"~     The purpose of this study is to investigate the effect of electroacupuncture on functional~     constipation.~   "
136398|NCT01781884|"~     This study is a multicenter, randomized, double-masked, placebo-controlled clinical study.~     All groups will receive standard intensive diabetes treatment with insulin and life style~     management. 60 subjects will be randomly assigned in a 1:1:1 ratio to receive placebo or~     different dosage of GABA.~      GABA is an amino acid produced from glutamate by glutamic acid decarboxylase. It was approved~     for the treatment of hepatic coma, fibromyalgia, ataxia in China and is widely used as~     supplement for the treatment of epilepsy, insomnia, stress and tobacco dependence. It has~     been recently shown that GABA can prevent and reverse the development of diabetes in type 1~     mice models. Participants will receive placebo or GABA for 52 weeks.~      The study will consist of 4 weeks screening period, 2 weeks run-in period, 52 weeks treatment~     period and 4 weeks follow-up period. Enrollment is expected to occur over 2 years.~      To assess the efficacy and safety of GABA for the treatment of juvenile type 1 diabetes in~     new onset subjects.~   "
136399|NCT01781871|"~     Severe Pneumococcal disease, such as bacteremia, meningitis and pneumonia, cause significant~     morbidity and mortality in both otherwise healthy adult population and in the~     immunocompromised patients. The incidence rate of invasive pneumococcal disease is~     considerably higher among organ transplant patients than in healthy individuals. Routine~     immunization with Pneumococcal vaccine is recommended pretransplant and once 3-5 years after~     the transplantation. The efficacy and immunogenicity of Pneumococcal polysaccharide~     vaccine(Pneumovax®) is suboptimal in this patient group. The conjugate Pneumococcal vaccine~     has been shown to be more immunogenic and safe in some other subgroups of immunocompromised~     patients. We intend to compare the immunogenicity of repeated dose 13-valent Pneumococcal~     conjugate vaccine (Prevenar13®)to the existing recommended protocol of Pneumococcal~     polysaccharide vaccine (Pneumovax®) in adult kidney and liver transplant patients.~   "
136400|NCT01781858|"~     The course of both pulmonary embolism (PE) and one of its more relevant late complications,~     i.e. chronic thromboembolic pulmonary hypertension (CTEPH) is still substantially unknown.~      Recent evidence has shown that the incidence of CTEPH is higher than previously believed, but~     this has not been confirmed by other studies. A clear link between PE and CTEPH has been~     questioned by some experts. A great number of patients affected by PE persistently have~     residual chronic thromboembolic material the meaning of which is a matter of debate. The~     evidence sustaining a link between chronic residual PE and subsequent PE recurrences or CTEPH~     is insufficient.~      Thus, a nationwide, multicentre, prospective cohort study was designed with the following~     aims:~        1. to ascertain the incidence of symptomatic CTEPH after a first episode of acute PE;~        2. to ascertain the incidence of venous thromboembolic (VTE) recurrences after a first~          episode of acute PE;~        3. to evaluate whether a relation exists between chronic residual PE and CTEPH~        4. to evaluate whether a relation exists between chronic residual PE and VTE recurrences;~        5. to evaluate whether a relation exists between persistent right ventricular dysfunction~          and CTEPH;~        6. to evaluate whether a relation exists between persistent right ventricular dysfunction~          and PE recurrences.~      For each enrolling centre, consecutive outpatients or inpatients with an objectively~     diagnosed first acute PE episode are considered eligible.~   "
136401|NCT01781845|"~     Pediatric upper urinary tract dilatation (hydronephrosis) is relatively common and may be~     either obstructive or nonobstructive. While the upper urinary tract is commonly evaluated by~     ultrasound, this imaging technique often fails to distinguish obstructed from nonobstructed~     systems. ARFI SVI is a new ultrasound technology that can be used to determine stiffness by~     measuring a tissue's shear wave velocity, may show alterations in parenchymal shear wave~     velocity in kidneys that show obstruction on DRS (Diuretic renal scintigraphy)which serves as~     the reference standard.~   "
136402|NCT01781832|"~     Urinary bladder fibrosis (thickening and scarring) is fairly uncommon in children.~     Traditionally, the presence of urinary bladder fibrosis has been confirmed directly with~     bladder biopsy or using urodynamic testing. In this study we will use ultrasound scanning and~     ARFI (acoustic radiation force impulse) wave velocities to potentially identify any urinary~     bladder wall fibrosis.~   "
136419|NCT01781611|"~     Dipyridamole, a medication extensively used in combination with aspirin for stroke~     prevention, is a promising new treatment for lupus. Dipyridamole has been shown to inhibit~     certain lymphocyte populations that are over-reactive in lupus and to delay the emergence of~     lupus-related pathology in mice with lupus. The investigators are interested in investigating~     the efficacy of dipyridamole in preventing flares in patients with lupus and its impact on~     biomarkers of disease activity.~   "
136403|NCT01781819|"~     Urine reflux (urine backing up into the kidneys) is common in the pediatric population and~     may be complicated by renal abnormalities, such as infection and scarring. Currently, urine~     reflux is detected using either voiding cystourethrogram or other procedures. A new technique~     called ultrasound-based Acoustic Radiation Force Impulse (ARFI), or shear wave velocity~     imaging SVI) is performed using standard approved ultrasound machines and transducers bu the~     sound waves/impulses are produced in a different pattern. We hope to evaluate the usefulness~     of ARFI in diagnosing possible kidney damage caused from urine reflux (urine backing up into~     the kidneys).~   "
136404|NCT01781806|"~     The purpose of this study is to evaluate the safety, acceptability and feasibility of~     delivery of Pre-Exposure Prophylaxis (PrEP) or Post-Exposure Prophylaxis) PEP as part of~     combination HIV prevention services for high-risk MSM and transgender women.~   "
136405|NCT01781793|"~     Exertional dyspnea is a major source of crippling distress and is the hallmark symptom of~     fibrotic interstitial lung disease (ILD). Due to the scientific community's poor~     understanding of the pathophysiological mechanisms of dyspnea there are no therapeutic~     interventions that consistently reduce dyspnea in this population. The investigators aim to~     determine the physiological mechanisms of exertional dyspnea in patients with fibrotic ILD~     and the impact of hyperoxia on exertional dyspnea and exercise endurance. This study will~     likely identify an important physiological mechanism of dyspnea in fibrotic ILD and may~     contribute to the development of effective therapies to reduce dyspnea in this population.~      The central hypothesis is that dyspnea in fibrotic ILD is primarily a result of an imbalance~     between the drive to breathe and the tidal volume response of the respiratory system (i.e.,~     neuromechanical uncoupling) and that experimental reduction of neuromechanical uncoupling via~     hyperoxic breathing will reduce exertional dyspnea and improve exercise endurance.~   "
136406|NCT01781780|"~     This is an experiment that will compare the effect of recommending breakfast consumption, or~     breakfast skipping, on body weight. Our objective is to determine if breakfast consumption~     recommendations can produce weight loss, and if that weight loss is dependent on typical~     breakfast eating habits.~   "
136407|NCT01781767|"~     This study objective is to evaluate the change in mitochondrial uncoupling protein 2 (UCP2)~     mRNA expression as function of thyroid activity (TSH, T3 and Free T4).~   "
136408|NCT01781754|"~     Many patients with Diabetes find difficulties in achieving glycemic control. Hemoglobin~     A1c(HgBA1c) is used as a marker for glycemic control. UCP2 is affected by high glucose~     levels, high free fatty acids and high oxidative stress.~      The investigators intend to learn about the changes in UCP2 along the process of reaching~     glycemic control.~   "
136409|NCT01781741|"~     This pilot clinical trial studies stereotactic body radiation therapy after surgery in~     treating patients with stage III-IV non-small cell lung cancer. Stereotactic radiation~     therapy may be able to send x-rays directly to the tumor and cause less damage to normal~     tissue. Lymphadenectomy may remove tumor cells that have spread to nearby lymph nodes in~     patients with non-small cell lung cancer. Giving stereotactic body radiation therapy after~     lymphadenectomy may kill any tumor cells that remain after surgery.~   "
136410|NCT01781728|"~     The investigators are looking to see if a certain dose of stereotactic body radiation therapy~     (SBRT) may be a viable treatment option for recurrent or residual pancreatic or periampullary~     adenocarcinoma.~   "
136411|NCT01781715|"~     The purpose of this study is to determine outcomes (death, myocardial infarction, target~     vessel revascularization (TVR), non-target vessel revascularization (non-TVR),~     stent-thrombosis) of 120 consecutive patients with ST elevation myocardial infarction and~     multivessel coronary artery disease undergoing multivessel stenting or staged percutaneous~     coronary intervention with Zotarolimus-eluting stents~   "
136412|NCT01781702|"~     A Randomized, Double-blind, Multicenter, Phase 3 Study of Pelubiprofen Tab. & Celebrex Cap.~     for Comparative Evaluation of Safety & Efficacy in Rheumatoid Arthritis Patients~   "
136413|NCT01781689|"~     Stroke is the most common cause of motor function impairment. However, the functional~     impairment is not totally irreversible. Several mechanisms may involved in both the cortical~     and motor function recovery after onset of stroke, and most of them are related to changes of~     cortical perfusion and metabolism.~      Motor function recovery after stroke (especially middle cerebral artery territory lesion)~     frequently follow stereotypic pattern (brunnström stage).~      This study is designed to investigate the relationship between motor cortex~     oxygenation/metabolism and motor function recovery after stroke. To seek if there is similar~     stereotypic pattern of motor cortex oxygenation/metabolism change during the recover stage~     after stroke.~   "
136414|NCT01781676|"~     This study was advocated by institute of Basic Research in Clinical Medicine,China Academy of~     Chinese Medical Sciences in October 2011.~      It was funded by China major scientific and technological specialized specialized project for~     'significant new formulation of net drugs'.~      Kudiezi(Yueanxin) is kind of Chinese Medicine injiection used for treating corinary heart~     diswese、angina pectoris and stroke in many Chinese hospitals.~      The purpose of this study is to determine adverse drug events or adverse drug reaction in~     large sample size 30,000 patients.~   "
136415|NCT01781663|"~     The main purpose of this study is to demonstrate the safety and efficacy of KAM2904 Face~     Cream and KAM3008 Body Lotion in reducing the symptoms of mild to moderate AD. Efficacy will~     be evaluated by comparing SCORAD and Eczema Area Severity Index (EASI) in a group of subjects~     treated with KAM2904 Face Cream and KAM3008 Body Lotion (the treatment group), versus a group~     of subjects treated with a petrolatum-based moisturizer (the control group). Safety will be~     determined by the number and severity of Adverse Events Device-Related.~   "
136416|NCT01781650|"~     Water-aided method for colonoscopy can be broadly subdivided into two major categories. Water~     Immersion (WI), characterized by suction removal of the infused water predominantly during~     the withdrawal phase of colonoscopy, and Water Exchange (WE), characterized by suction~     removal of infused water predominantly during the insertion phase of colonoscopy. Several~     studies showed that WE significantly reduces pain compared to WI and colonoscopy with~     traditional air insufflation (AI), increases the number of unsedated procedures and adenoma~     detection rate (ADR), in particular proximal ADR. This randomized controlled trial will be a~     direct comparison of Air Insufflation, Water Immersion and Water Exchange to test the~     hypothesis that WAC (particularly WE) would significantly decrease pain score during~     colonoscopy in diagnostic patients. Several other secondary outcomes will also be analyzed.~   "
136421|NCT01781585|"~     Hemodynamic instability occurs frequently during dialysis treatment and still remains as~     significant cause of patient mobility and mortality. Postoperative hemodynamic optimization~     has been proved to reduce morbidity in high-risk patients. Intracranial pressure increased~     can lead to further structural and functional impairment owing to its deleterious effect on~     the compromised microcirculation and metabolism. This study was to compare the intra-cerebral~     pressure (ICP) and hemodynamic parameters between the sustained low-efficiency dialysis~     (SLED) and continuous veno-venous hemofiltration (CVVH) in post- brain tramatic patients.~   "
136422|NCT01781572|"~     In the phase Ib, the primary purpose is to establish the maximum tolerated dose~     (MTD)(s)/recommended phase ll dose (RP2D) and schedule of LEE011 and MEK162 orally~     administered combination. Once the MTD(s)/RP2D have been determined for each tested schedule,~     additional patients will be enrolled in the phase II portion of the study at the RP2D on the~     chosen schedule in order to assess the anti-tumor activity of the combination in addition to~     continued evaluation of safety.~   "
136423|NCT01781559|"~     The objective is to demonstrate the effect of phenolic acids on endothelial function.~   "
136424|NCT01781546|"~     The purpose of this study is to compare DEB with BMS in CAD patients who are at high risk of~     bleeding and in whom the use of DES is therefore avoided. Our hypothesis is that PCI with DEB~     is non-inferior to BMS in the treatment of stable CAD or in ACS (UAP or NSTEMI) in patients~     at high risk of bleeding.~   "
136425|NCT01781533|"~     To investigate the performance of a software-algorithm based insulin therapy to control blood~     glucose in Type 1 diabetic patients.~   "
136426|NCT01781520|"~     The purpose of this study is to evaluate the antitumor effect and safety of clinical~     effectiveness S-1 plus dendritic cell activated Cytokine induced killer treatment (DC-CIK)~     for unresectable locally advanced pancreatic cancer.~   "
136427|NCT01781507|"~     Primary Objective :~      To compare the acute bronchodilatory effects of cetirizine 10 mg tablet and nebulized~     levalbuterol using impulse oscillometry technique in asthmatic subjects aged 18 to 65 years~     old who have allergic rhinitis and show clinical evidence of bronchial hyper-reactivity.~      Secondary Objective:~      To assess the bronchodilatory effects of cetirizine 10 mg tablet versus placebo after two~     weeks of therapy using impulse oscillometry technique in subjects 18 to 65 years old who have~     allergic rhinitis and show clinical evidence of bronchial hyper-reactivity.~   "
136428|NCT01781494|"~     The goal of this study is to test the hypothesis that immediate elbow motion is safe after~     anterior submuscular ulnar nerve transposition, and will not result in disruption of the~     repaired flexor pronator origin, under which the nerve is placed. The advantages of immediate~     elbow motion after submuscular ulnar nerve transposition for performing activities of daily~     living and self-care are evident, however theoretical advantages include early gliding of~     the transposed ulnar nerve with a lower risk of nerve adhesions and subsequent traction~     neuritis, as well as improved blood flow and quicker, more complete, recovery of nerve~     function.~      A group of 44 consecutive patients that are determined to be candidates for anterior~     submuscular ulnar nerve transposition based on history, positive findings on physical~     examination, and confirmatory electrodiagnostic testing will be prospectively randomized to~     either immediate motion or long arm cast immobilization after surgery. All patients will be~     counseled about the two postoperative treatment options (immobilization followed by protected~     range of motion versus immediate range of motion), risks involved with each treatment~     protocol, postoperative follow-up and need for radiographs. If they choose not to~     participate, they will be treated by the same postoperative protocol currently used by the~     principal investigator: arm sling at rest for six weeks with intermittent active assisted~     range of motion exercises.~   "
136429|NCT01781481|"~     The investigators have recently developed a paediatric adaptation of the INTERMED tool to~     address the unique developmental and social contexts of children and youth. The Pediatric~     INTERMED adopts a life-chart methodology to structure and organize complex case material in~     time, colour-coding domains to facilitate identification of areas of high need and risk for~     each patient. The focus of the present study is to examine the characteristics and usefulness~     of the tool in identifying psychosocial stress in children/youth diagnosed with Inflammatory~     Bowel Disease (IBD), as well as identifying overall case complexity. Children and parents~     will participate in a semi-structured structured interview with a clinical nurse who will~     then rate the 34-PIM items. To examine the construct validity of each of the Pediatric~     INTERMED domains (biological, psychological, social, caregiver/family, health care system)~     participants will complete questionnaires assessing social and psychological functioning,~     parent and family stress, quality of life and adaptive functioning. Information about disease~     status, and health care utilization will be obtained from medical chart review. It is~     hypothesized that greater case complexity will be predictive of more complex disease~     course/treatment, poorer quality of life, and increased health care utilization.~   "
136430|NCT01781468|"~     This randomized phase III trial studies armodafinil to see how well it works in reducing~     cancer-related fatigue in patients with high grade glioma. Armodafinil may help relieve~     fatigue in patients with high grade glioma.~   "
136431|NCT01781455|"~     This is an open label, single arm dose escalation study of BBI503 in adult patients with~     advanced solid tumors.~   "
136432|NCT01781442|"~     This is a post marketing surveillance which determines the safety profile of the product to~     Filipinos. This is a FDA requirement for registration.~   "
136433|NCT01781429|"~     This open-label, multi-center Phase 1/2 study will assess the safety, pharmacokinetics, and~     pharmacodynamics of escalating doses of BVD-523 in patients with advanced malignancies. The~     study also seeks to demonstrate target modulation and early signs of clinical response in~     select patient populations.~   "
136434|NCT01781416|"~     This is a national, non interventional, prospective study performed in the general practice~     setting.~      The study has been designed :~        -  to assess the level of concordance between patients' cardiovascular risk perception and~          the cardiovascular risk evaluated by the physicians,~        -  and to evaluate the impact of patients' exposure to a medical information leaflet on~          patients' cardiovascular risk perception.~   "
137281|NCT01770327|"~     The purpose of this study is to determine if water and three different sugary beverages~     (milk, Orange juice and iced tea) have the same effect on thirst.~   "
137282|NCT01770314|"~     The purpose of this project is to test whether an online pain medication intervention is a~     feasible and effective way to increase opioid pain medication safety.~   "
136435|NCT01781403|"~     The investigators planned a phase I study of preoperative CRT with capecitabine plus~     temozolomide inpatients with locally advanced resectable rectal cancer: 1) the role of~     temozolomide as a radiosensitizer has been well established, 2) hypermethylation (or low~     expression) of MGMT promoter is associated with colorectal carcinogenesis, can be found in~     20~40% of colorectal cancer patients, and this proportion could be adequate for validation as~     its role of predictive biomarker, and 3) temozolomide can be additive or synergistic because~     radiotherapy is now essential in the treatment of rectal cancer.~   "
136436|NCT01781390|"~     This is a double blind, randomized, placebo controlled study that will enroll 105 subjects~     with de novo anterior myocardial infarction due to a lesion of the left anterior descending~     coronary artery undergoing PCI. Eligible subjects will be enrolled and undergo~     revascularization of the culprit LAD followed by an intracoronary (IC) delivery of the~     assigned treatment, infused into the stented culprit artery. The study will determine the~     safety and feasibility of the IC infusion of investigational MPCs in this patient population.~   "
136437|NCT01781377|"~     Perioperative nausea and vomiting may occur in 50-80% of patients undergoing cesarean~     section.~      Metoclopramide is a well known Dopamine receptor antagonist that acts at the Chemoreceptor~     trigger zone and is used effectively for the prevention and treatment of nausea and vomiting.~     Propofol can antagonize Serotonin receptors in the area postremal and is associated to a~     reduced incidence of postoperative nausea and vomiting. Some studies have shown that propofol~     can prevent intraoperative nausea and vomiting during cesarean section.~      The control of risk factors and the pharmacological prophylaxis of nausea and vomiting~     reduces effectively their incidence.~      In this randomized, double blind, case-control study the efficacy of propofol alone,~     metoclopramide alone and in combination in controlling nausea and vomiting were compared. A~     risk factor control strategy was associated to each study group.~   "
136438|NCT01781364|"~     The purpose of this study is to reveal the specific effects of computer-aided cognitive~     training on course and rehabilitation in early onset schizophrenia~   "
136439|NCT01781351|"~     Untreated ankle sprains often remain symptomatic and may end in chronic instability. The aim~     of our study is to quantify the stabilizing effect of different devices. Through the combined~     use of the 3D motion analysis and the surface electromyography, the influence of the devices~     with respect to a mechanical effect and to an influence on the neuromuscular control are~     examined. The tests will simulate situations with a higher risk of injury. In the~     experimental set-up, an element of surprise will be integrated in order to analyze any~     muscular compensation mechanisms.~   "
136440|NCT01781338|"~     Trial for the optimization of risk assessment and therapy success prediction in patients with~     early breast cancer by the use of biomarkers in advance to therapy decision-making to~     personalize therapies.~   "
136441|NCT01781325|"~     Our objective is to develop an IBEHR (Image-Based Electronic Health Record) to show patients~     how to reproduce at home the exercises prescribed by their physical therapist (PT) in clinic.~     The IBEHR can also record home exercise sessions for review by and feedback from the PT. The~     HEALTH CARE BENEFITS of the IBEHR for patient self monitoring are: improved transfer of~     physical therapy exercise from clinic to home, increased adherence to the exercise~     prescription, and recording home exercise to assist PT decision making.~   "
136442|NCT01781312|"~     Recent studies have shown an increased gastrointestinal reactivity and increased intestinal~     permeability in IgA nephropathy (IgAN). Probiotic supplementation is known to impact the~     gastrointestinal immune system possibly by improvement of both the immunologic and the~     non-immunologic intestinal barrier. Probiotic supplementation should thus theoretically have~     an effect on IgAN. In this study the investigators will study the efficacy and safety of~     Lactobacillus reuteri.~   "
136443|NCT01781299|"~     The purpose of this study is to assess the relative performance and complication rates~     between the AlloDerm RTU and SurgiMend PRS products as well as the relative economics of~     these two treatment options.~   "
136444|NCT01781286|"~     The purpose of this study is to examine the effects of normal vs. protein-rich afternoon~     snacks on appetite control, satiety, and reward-driven eating (particularly in the evening)~     in young people. Indices of attention and mood will also be assessed.~      Study hypotheses include the following:~        1. The consumption of a high-protein, soy-rich afternoon snack will lead to significant~          improvements in appetite control and satiety, reductions in food motivation and reward,~          and will delay the drive to eat in normal to overweight young people.~        2. The consumption of a high-protein, soy-rich afternoon snack will lead to reduced~          unhealthy, evening snacking, particularly on foods high in fat and/or sugar, in normal~          to overweight young people.~        3. The daily consumption of a high-protein, soy-rich afternoon snack will lead to~          significant improvements in afternoon alertness, concentration, fatigue, and well-being~          in normal to overweight young people.~   "
136445|NCT01781273|"~     This four-way, dose-response, crossover, double blind, placebo-controlled, randomised~     validation study investigates the responsiveness of MedDrive, a computed battery of~     neuropsychological tasks, to different doses of alcohol.~      The following hypothesis are tested:~        1. Measures from MedDrive are influenced by alcohol in a dose dependent way.~        2. Effects of alcohol on driving performances are correlated to measures from MedDrive in a~          dose dependent way.~        3. Within a group of healthy young drivers, MedDrive shows consistent results over repeated~          measures (ICC≥0.7).~        4. MedDrive models effects of alcohol on driving performances better than does the UFOV or~          the trial making task.~   "
136468|NCT01780974|"~     The primary aim of the pilot study is to provide data that can be used to better determine~     sample size for the design of a larger clinical trial. The pilot will evaluate the~     effectiveness of Lipoic Acid (LA) plus Omega-3 fatty acids (Omega-3) on preventing~     Alzheimer's Disease (AD). The investigators will also collect data to evaluate recruitment~     rate, safety, and compliance over the 12 month study period.~   "
136469|NCT01780961|"~     To create an esophageal cancer biospecimen repository that will collect, annotate, store and~     distribute human esophageal cancer biospecimens in a manner that embraces the highest ethical~     standards of human subject's research, that conforms to the best practices of biorepository~     science and that furthers basic, translational and clinical research in the understanding~     diagnosis and treatment of this disease.~   "
136446|NCT01781260|"~     Recent occurrence of significant post-operative liver impairment at Nottingham University~     Hospitals NHS Trust has prompted investigation into whether interaction between general~     anaesthesia and prone positioning (lying face down) for surgery can influence liver function.~      Historical research has shown that the heart does not function as efficiently when an~     anaesthetised patient is placed in the prone position for surgery. The techniques used for~     anaesthetising and monitoring these patients have changed remarkably, since these studies~     were first performed.~      It is important to know accurately how the heart functions to enable better understanding of~     the changes in blood flow to the liver when in the prone position.~      Studies looking at blood flow to the liver when lying face down have been done before but are~     mainly reporting patients on the intensive care unit. These intensive care patients are~     different to those in theatre undergoing routine surgery. The intensive care patients are~     usually received in different types of drugs and monitored with several different types of~     monitor at the time. Perhaps most importantly is that they are placed face down on a soft air~     cushioned mattress and pillows rather than the rigid support used for surgical patients.~      This study will look at whether the function of the liver changes when a patient is~     anaesthetised and is then rolled onto their front. The function of the liver will be measured~     by looking how it clears a specific drug from the blood. Also this study will look at how~     accurate a particular type of heart monitor is when an anaesthetised patient is placed onto~     their front.~   "
136447|NCT01781247|"~     Posttraumatic Stress Disorder (PTSD) is a mental disorder that may occur after someone~     experiences a traumatic event. Between 10-20% of patients may develop PTSD in response to the~     traumatic experience of myocardial infarction (MI). PTSD is associated with impaired quality~     of life, social functioning, and high economic burden to the society. Posttraumatic stress~     attributable to MI has also been shown to be predictive of poor cardiovascular prognosis,~     whereby this link might relate to several atherothrombotic processes. Therefore the~     prevention of PTSD after MI is of high relevance. Guidelines have been published for early~     interventions to prevent the development of posttraumatic stress after different types of~     trauma but not in terms of acute MI as a traumatic event.~      The overarching aim of the planned trial is to test whether a minimal behavioral intervention~     performed shortly after acute MI in patients at a high risk to develop PTSD and in the~     setting of a coronary care unit reduces the development of posttraumatic stress.~      The primary hypothesis is that posttraumatic stress levels at the 3-month follow-up will be~     at least 20% lower in the intervention group than in the control group, and that this effect~     will last up to 12 months after the intervention. The secondary hypothesis is that the~     intervention group will show better psychosocial functioning, and a more favourable~     cardiometabolic biomarker profile than the control group 3 and 12 month after the~     intervention.~   "
136448|NCT01781234|"~     This study will evaluate safety and efficacy of intranasal insulin in abstinent smokers.~     Groups' (placebo vs. insulin) cognitive function and stress response will be compared.~   "
136449|NCT01781221|"~     The purpose of this study is to compare the regenerative results of using separately two~     different xenografts after two-step sinus floor elevation.~   "
136450|NCT01781208|"~     ARFI (Ultrasound-based Acoustic Radiation Force Impulse) will be used during ultrasound~     guided needle biopsy of the liver of children.~   "
136451|NCT01781195|"~     Prolonged-release low-dose Advagraf should better protect from CNI-side effects compared to~     standard immunosuppressive regiments while the rate of rejection is not increased and thus~     graft function is well maintained. We hypothesize that especially in high-MELD (MELD-score~     >20) recipients who have a decreased immune competence the prolonged-release low-dose~     Advagraf concept would better protect from side effects of immunosuppression (i.e.~     infection). Nevertheless, we assume that also patients with a MELD-score ≤20 will benefit~     from this concept in regard to lower infection rates and less side effects of~     immunosuppression.~   "
136452|NCT01781182|"~     Escalating resistance to antibiotics among disease-causing community bacteria increasingly~     threatens our ability to treat patients' infections. At the level of the physician-patient~     encounter, incentives at the patient level often take priority to society; this is often the~     case with antibiotic prescribing. Each patient level antibiotic treatment decision is based~     on how we value potential outcomes, including short-term benefits and risks and longer-term~     risks, including those related to future bacterial resistance to antibiotics. Unfortunately,~     antibiotics are often prescribed for illnesses unlikely to have a bacterial etiology; even a~     very small likelihood of benefit seems to outweigh an increased risk of future antibiotic~     resistance. While short-term effects of antibiotics on colonization with resistant bacteria~     have been demonstrated, the overall implications of each treatment for future individual,~     family and societal-level resistance remain difficult to quantify, and are often steeply~     discounted or ignored during decision-making. Knowledge regarding the longer-term effects of~     personal and household antibiotic use could better quantify these future resistance-related~     risks, and help guide antibiotic decision-making for physicians and patients.~      Infants are born with sterile nasopharyngeal and gastrointestinal tracts and yet, during the~     1st year of life, become important reservoirs of resistant organisms; this creates an~     opportunity to study colonization and resistance starting from a microbiological tabula rasa.~     In this proposal, we will use an observational cohort to following newborns' antibiotic~     exposure and longitudinal colonization with specific bacterial pathogens and related~     antibiotic resistance in the 1st year of life. Our hypothesis is that during the 1st year of~     life, infants with personal and household antibiotic exposure will have greater colonization~     with resistan organisms than infants without antibiotic exposure. This project will help us~     understand the development of bacteria that are resistant to antibiotics within the~     community, and help to inform judicious decision-making regarding antibiotic prescribing.~   "
136453|NCT01781169|"~     Hypothesis: Oral Supplementation of Vitamin D can Reduce Hypersecretion of Parathyroid~     Hormone and Insulin Resistance in Obese Chinese Males.~      Protocol: Weekly oral supplementation of 50,000 IU vitamin D (cholecalciferol) or eight weeks~     to the obese males compared with the normal-weight males. Index measures were conducted at~     baseline and endpoint.~   "
136454|NCT01781156|"~     Hyperphosphatemia and elevated cardiac biomarkers are two key characteristics of patients in~     end stage renal diseases(ESRD),however the majority of whom are in the absence of acute~     coronary syndrome(ACS). And it is still unclear why cardiac biomarkers would increase in~     those patients. We hypothesized that excessive phosphorus is account for that phenomenon.To~     confirm that hypothesis,we used one phosphorus binder to reduce phosphorus absorption in~     hemodialysis patients for some time and observed the change of cardiac biomarkers of those~     patients.~   "
136455|NCT01781143|"~     The SOET project introduces a new strategy for routine follow-up of follicle growth during~     the hormonal treatment phase of an in-vitro fertilization (IVF) treatment cycle. After a~     learning instruction and demo, patients should be able to perform most of their vaginal~     echoes at home. The images can be sent to the medical center over the internet. These images~     are analyzed by the expert.~   "
139937|NCT01735695|"~     The purpose of this study is to collect amniotic fluid samples from pregnant women. Amniotic~     fluid samples will be tested for meconium with a new assay. The results will be correlated~     with other laboratory tests.~   "
136456|NCT01781130|"~     Background~      Present treatment strategies for trigger finger when conservative management including~     steroid injection was failed include percutaneous or open A1 pulley release, but some people~     showed prolonged swelling and delay of complete healing.~      We aimed to test the hypothesis that an improved outcome can be achieved by employing steroid~     injection simultaneously with percutaneous release compared with conventional percutaneous~     release alone~      Methods~      We designed a double-blind, randomized controlled trial.~      Inclusion criteria is the patient who has symptom of trigger finger warranted surgical~     release after sufficient time of conservative treatment.~      Exclusion criteria are as follow: 1) multiple fingers at presentation; 2) Rheumatoid~     arthritis patients; 3) Pregnant or lactating patients; 4) Younger than 18 years old; 5)~     Previous surgery history of finger 6); the patients who got steroid injection more than 4~     time previously; 7) coagulation abnormality including usage of anti-thrombotic agent.~      After power analysis by a statistician, total 40 patients would be required for each group~     (percutaneous alone group versus percutaneous alone + steroid injection group).~      The surgery will be performed by outpatients clinic basis with local injection. Additional~     steroid injection will be given to half of patients after allocation with randomized~     selection by permutaed block randomization.~      Primary outcome measure is mean fall in pain visual analogue scale (pVAS) and secondary~     outcome will be proportion of patients with good response (defined as Perfect or much~     better as reported by patients).~      Follow-up will be conducted 3 weeks and 3 month after index procedure~   "
136457|NCT01781117|"~     Persistent detrusor overactivity (DO) after transurethral prostatectomy results in~     symptomatic failure in more than one third of the patients. Storage symptoms are major~     complaints in the early postoperative period after Holmium Laser Enucleation of the Prostate~     (HoLEP). Levels of the urinary nerve growth factor (NGF), produced by bladder urothelium and~     smooth muscle, are increased in the patients with overactive bladder (OAB), and decreased~     after the OAB symptoms were improved. Also, urinary NGF levels are increased in patients with~     benign prostatic obstruction (BPO), but the changes of the NGF levels after relief of the BPO~     by the medical or surgical treatment have not been fully investigated. If the elevated~     urinary NGF levels are reduced after successful surgical treatment of BPO, measurement of~     urinary NGF could be a useful objective tool to assess the therapeutic outcomes of the~     operation.~      The aims of this study are to measure the urinary NGF levels in patients with BPO and to~     compare the results between the patients with detrusor overactivity (DO) and without detrusor~     overactivity (Non-DO), average 2 weeks before Holmium Laser Enucleation of the Prostate~     (HoLEP) procedure. After HoLEP, urinary NGF levels are rechecked at the periods of~     postoperative 3 months and 6 months, and compare changes between the two groups.~   "
136458|NCT01781104|"~     The purpose of this study is to evaluate safety and tolerability as well as the effects of~     RM-131 on colonic transit, bowel consistency, bowel habits, abdominal pain, and other~     abdominal symptoms in patients with chronic constipation.~   "
136459|NCT01781091|"~     Preliminary study to compare IntelliVent-ASV to conventional modes used from intubation to~     extubation or death in ICU patients requiring mechanical ventilation measuring duration of~     mechanical ventilation in order to design a multicenter large trial.~   "
136460|NCT01781078|"~     The objective of the SAMURAI Clinical Study is to collect data to confirm the safety,~     performance and effectiveness of the ImageReady System for use in the Magnetic Resonance~     Imaging (MRI) environment when used in accordance with the Conditions of Use included in the~     Boston Scientific MRI Technical Guide~   "
136461|NCT01781065|"~     The purpose of this study is to evaluate the analgesic effect of transcranial direct current~     stimulation (tDCS) applied on motor cortex in patients with spinal cord injury who have~     chronic neuropathic pain.~   "
136462|NCT01781052|"~     This prospective, non-interventional, multi-center study documents observational data on~     subjects under routine treatment of Pulmonary Arterial Hypertension, functional class III~     with inhaled Iloprost administered with I-Neb AAD (Adaptive Aerosol Delivery) device. The~     observation period for each subject covers a one year treatment period with inhaled Ventavis.~     For each subject, the investigator or a delegate collects data as defined in the case report~     form at an initial visit, routine follow-up visit at 6 months and final visit at 12 months.~   "
136463|NCT01781039|"~     Understanding speech is essential for good communication. Individuals with hearing loss and~     poor speech discrimination often have little success with hearing aids because amplifying~     sound improves audibility, but not clarity of the speech signal. The purpose of this study is~     to determine the relative importance of the sensory cells of the inner ear and auditory~     neurons on speech discrimination performance in quiet and in noise. This information may be~     used as a predictor of hearing aid benefit. The investigators expect to find decreased speech~     understanding ability resulting from both loss of sensory cells and the loss of auditory~     neurons.~   "
136464|NCT01781026|"~     The purpose of this trial is to study the activity of vemurafenib in untreated melanoma brain~     metastases harboring B-Raf proto-oncogene, serine/threonine kinase (BRAF) mutations that are~     not amenable to stereotactic radiosurgery based on size, number of lesions or location, to~     measure cerebrospinal fluid (CSF) levels of vemurafenib as an indicator of central nervous~     system penetrance and to measure levels of vemurafenib in normal brain tissue and brain~     metastases in those in whom surgical management is feasible.~   "
136465|NCT01781013|"~     The specific aims of the proposed study are to:~        1. Develop the innovative depression care management technology, including the speech~          recognition technology for automated monitoring and patient prompts over time, automatic~          integration of the responses into the patient registry, and evidence-based~          decision-support algorithms for care actions;~        2. Conduct the quasi-experiment in eight Los Angeles County Department of Health Services~          (LAC-DHS) clinics to test the interventions;~        3. Use mixed-method evaluation to assess the extent of the implementation of the~          interventions, the acceptance to the providers and to the patients, and the impact on~          adoption of depression screening and treatment management over time, utilization, and~          cost of healthcare services, and patient health outcomes; and~        4. Conduct a cost-effectiveness analysis of the three study arms. Successful completion of~          the study will demonstrate which Comparative Effectiveness Research (CER) adoption~          strategies are successful and why, their comparative cost-effectiveness, as well as~          which strategies are successful under which circumstances to inform system-wide~          implementation of same.~      Hypotheses of the Proposed Study~      The following are the main hypotheses of the study:~        1. There will be statistically significant difference in the adoption of depression care~          screening and management over time among the three study groups.~           1.1. The adoption rate will be Technology-supported care (TC) > Supported Care (SC) >~          Usual Care (UC).~        2. There will be statistically significant difference in the depression symptom reduction,~          and better functional status, and quality of life among the three study groups.~           2.1. The difference between the TC and the SC will not be statistically significant, but~          both will be greater than the UC group.~        3. There will be statistically significant difference in the diabetes care process and~          outcomes among the three study groups.~           3.1. The difference between the TC and the SC will not be statistically significant, but~          both will be greater than the UC group.~        4. There will also be statistically significant differences in healthcare utilization among~          the three study groups, with least utilization in the TC group where the greatest level~          of technology is applied.~        5. Of the three groups compared, the TC group will be the most cost-effective approach for~          accelerating adoption of the CER depression care results.~   "
136470|NCT01780948|"~     Hypothesis : In renal transplantation recipient who received immunosuppressive drug~     certican and have hypercholesterolemia will get lipid lower drug-HMG Co-A reductase~     inhibitors. Because atorvastatin and everolimus have metabolism via Cytochrome P450 subfamily~     3A4 both, so investigator made the hypothesis that when patients received everolimus with~     atorvastatin will change area under the time concentration curve of everolimus.~   "
136471|NCT01780935|"~     This study will evaluate and compare two individualized ranibizumab treatment regimens in~     patients with neovascular (wet) AMD aiming to achieve and to maintain a maximum visual~     function benefit, while aiming to avoid unnecessary intravitreal injections.~      The results will be used to generate further recommendations on functional and anatomical~     monitoring of the disease and timing of treatment administration for patients with~     neovascular AMD. In this context, the study will investigate the utility of optical coherence~     tomography (OCT) to aid retreatment decisions with ranibizumab.~   "
136472|NCT01780922|"~     The purpose of this study is to determine the effects of a single dose of cranberry beverage~     in healthy adults on the kinetic uptake of polyphenol compounds and polyphenol metabolites,~     and antioxidative and anti-inflammatory activity.~   "
136473|NCT01780909|"~     Aim of the study The aim of this study is to use Gabbroral® oral tablet formulation as marker~     for the evaluation of the gastrointestinal transit. By collecting and analyzing both gastric~     and intestinal fluids on different time points, the transfer dissolution can be distracted.~     For this study stomach fluid and intestinal fluid will be collected after oral intake of a~     commercially available dosing form of Paromomycin Sulfate (Gabbroral® oral tablet~     formulation), which is dissolved in a glas of 240mL water, in fasted or fed state. Four~     intake conditions will be tested on four different test days (with an intermediate period of~     at least 7 days).~        1. intake of Gabbroral® oral tablet formulation, which will be dissolved in a glas of 240mL~          water, in fasted state.~        2. intake of Gabbroral® oral tablet formulation in fed state.~        3. Intake of 2 tablets of Motilium® (API: domperidone 10 mg) 20 minutes before the intake~          of Gabbroral® oral tablet formulation, which will be dissolved in a glas of 240mL water.~        4. Intake of 2 tablets of Motilium® (API: loperamide HCl 2 mg) 20 minutes before the intake~          of Gabbroral® oral tablet formulation, which will be dissolved in a glas of 240mL water.~      Conduct of the study~        -  The study consists of four testing days in the University Hospitals Leuven, Gasthuisberg~          campus.~        -  On each test day you come at the agreed time in fasting State to the Gastroenterology~          Department at UZ Leuven (Gasthuisberg, floor 0, Orange arrow). Fasted state means that~          you have eaten nothing for 12 hours for the investigation and only have been drinking~          water.~        -  A basic clinical anamnesis will be taken by a doctor to make sure that you are a healthy~          volunteer for our study. For making sure that you are HIV negative, you will undergo an~          HIV test. In case of a female volunteer, a pregnancy test will be taken in account to~          make sure you are not pregnant.~        -  Upon arrival at the hospital through the nose or the mouth two probes: one in the~          stomach and one in the gut. The position of both probes is controlled using fluoroscopy~          (x-ray).~        -  After a stabilisation period of ca. 20 min you will be asked for taking a single dose of~          Gabbroral® oral tablet formulation. On four different test days, with an intermediate~          period of at least 7 days, we will follow every one of following intake conditions:~             1. intake of Gabbroral® oral tablet formulation, which will be dissolved in a glas of~               240mL water, in fasted state.~             2. intake of Gabbroral® oral tablet formulation in fed state.~             3. Intake of 2 tablets of Motilium® (API: domperidone 10 mg) 20 minutes before the~               intake of Gabbroral® oral tablet formulation, which will be dissolved in a glas of~               240mL water.~             4. Intake of 2 tablets of Motilium® (API: loperamide HCl 2 mg) 20 minutes before the~               intake of Gabbroral® oral tablet formulation, which will be dissolved in a glas of~               240mL water.~        -  After intake of the medicine at regular intervals, gastrointestinal fluids will be~          aspirated over 4 hours. You sit in a comfortable position in bed; eating and sleeping is~          not permitted (after 2 hours you have the possibility to drink some water).~        -  After 4 hours, the gastrointestinal catheters will be removed and you may eat and roam~          freely.~   "
136474|NCT01780896|"~     The purpose of this study is to evaluate visual and nonvisual topographic memory impairment~     and its relationship to vestibular function in humans. Topographic memory refers to the~     ability to remember current and past locations in topographic (navigational) space and to~     make and/or adjust to spatial transformations using such memories. Performance on each of~     these topographic memory tasks will be compared to performance on a set of comparable~     nontopographic memory tasks. Topographic impairments represent some of the earliest cognitive~     deficits observed in Alzheimer's Disease, and the brain areas involved in topographic memory~     are the first to show degenerative changes.~   "
136475|NCT01780883|"~     Melatonin is a neurohormone produced from serotonin which promotes sleep. The alterations in~     central and peripheral serotonin neurobiology and in circadian sleep-wake rhythms observed in~     autistic disorder suggest abnormalities in melatonin secretion.~      Several studies have reported a decrease in melatonin secretion in individuals with autism.~     Furthermore, nocturnal excretion of 6-Sulphatoxymelatonin (the predominant melatonin~     metabolite) was significantly negatively correlated with severity of autistic impairments in~     verbal communication and play. Melatonin could therefore have a therapeutic effect on sleep~     problems and may play a role in the pathophysiology of autistic disorder.~      These data highlight the possible therapeutic interest of an oral administration of melatonin~     in patients with autistic disorder. Thus, the objective of this clinical trial is to study~     the relation between the melatonin dose administered and its effect on severity of autistic~     impairments especially in verbal communication and play.~   "
136476|NCT01780870|"~     The main purpose of this study is to assess factors mediating the changes in insulin~     sensitivity and glucose tolerance before and after 10 lbs ± or 2% weight loss reduction as~     well as 2, 3, 6, 12, and 24 months after initiation of a low calorie diet.~      The investigators will also study the following:~        1. The impact of diet induced weight loss on hormones/adipokine levels~        2. The impact of diet induced weight loss on leptin tolerance~   "
136477|NCT01780857|"~     This study is being done to learn more about a less common type of psoriasis, called~     palmoplantar pustulosis (PPP). The majority of the current treatments used for this type of~     psoriasis have only a moderate effect on PPP. Thus, the investigators believe that PPP may be~     a different disease entity altogether, requiring different therapies. As such, the~     investigators hope to discover an immune signature for this condition.~      An immune signature is the unique way in which the combination of genes, cells, and~     proteins of the immune system work for each person. Because both psoriasis and the type of~     psoriasis patients have been diagnosed with, PPP, are conditions of abnormal immune system~     function, it is important to understand the overall function of the immune system in this~     condition (that is, find the immune signature). This study should help identify an immune~     system signature in people with PPP.~      The investigators have a laboratory technology which allows them to read the genetic~     signatures of a person's blood cells. Genes contain the instructions for making living~     things. Genes are contained in the cells' DNA (deoxyribonucleic acid). Most DNA is the same~     among humans, but the small differences people have in their DNA may explain why people~     develop different diseases. DNA and the genes it contains help produce RNA (ribonucleic~     acid), which in turn helps make proteins in people's cells. Differences in the types of~     proteins and the amount of those different proteins people's cells produce can affect a~     person's immune system.~      To help the investigators determine the immune signature in PPP, they will be examining the~     different genes, cells, and proteins that are active in patients with PPP versus patients who~     do not have the condition. The investigators will examine these genes, cells, and proteins in~     skin (through a skin sample) and in blood (through a blood draw). The goal is to develop new~     treatments for this skin condition. To do this, the investigators need to compare the skin~     and blood of patients with this particular type of psoriasis to the samples of healthy~     patients.~   "
136478|NCT01780844|"~     The purpose of this study is to evaluate the efficacy and safety of ASKP1240, an anti-CD40~     monoclonal antibody, for the prophylaxis of organ rejection after kidney transplantation.~     This study will compare the efficacy of basiliximab induction, ASKP1240, mycophenolate~     mofetil (MMF), and steroids [calcineurin inhibitor (CNI) avoidance] to the standard of care~     immunosuppressive regimen (basiliximab induction + tacrolimus + MMF + steroids). In addition,~     the study will compare the efficacy of basiliximab induction, ASKP1240, tacrolimus and~     steroids [CNI minimization-MMF avoidance] to the standard of care immunosuppressive regimen~     (basiliximab induction + tacrolimus + MMF + steroids).~   "
136479|NCT01780831|"~     This study will evaluate the safety and pharmacokinetics (PKs) of raltegravir (RAL) given to~     HIV-1-exposed newborn infants at risk of acquiring HIV-1 infection. (Pharmacokinetics are the~     various interactions between a drug and the body.) This study will also evaluate the~     appropriate dose of RAL to give to an infant to prevent the infant from getting HIV infection~     from its mother.~   "
136480|NCT01780818|"~     Water-aided method for colonoscopy can be broadly subdivided into two major categories. Water~     Immersion (WI), characterized by suction removal of the infused water predominantly during~     the withdrawal phase of colonoscopy, and Water Exchange (WE), characterized by suction~     removal of infused water predominantly during the insertion phase of colonoscopy. Several~     studies showed that WE significantly reduces pain compared to WI and colonoscopy with~     traditional air insufflation (AI), increases the number of unsedated procedures and adenoma~     detection rate (ADR), in particular proximal ADR. This randomized controlled trial will be a~     direct comparison of Air Insufflation, Water Immersion and Water Exchange to test the~     hypothesis that WAC (particularly WE) would significantly decrease pain score during~     colonoscopy in average-risk screening patients. Several other secondary outcomes will also be~     analyzed.~   "
136481|NCT01780805|"~     This study involves completion of questionnaires, computer-based cognitive tasks and an~     alcohol drinking session. Participation in this study consists of an initial, in-person~     screening appointment, 4 brief daily appointments at the research office, an alcohol drinking~     session at a local bar and a follow-up appointment 1-3 days after the alcohol drinking~     session.~      Participants who are found to be eligible in the screening phase will then complete a daily~     appointment for 4 days out of a 5-day period (i.e., there will be 1 day out of the 5 on which~     they will not attend an appointment). Each appointment will last 20 minutes, on average and~     consist of a questionnaire and computer-based cognitive task. On the day of the fourth~     appointment, participants will complete an alcohol drinking session. The alcohol drinking~     session begins at 4pm and lasts until at least midnight.~      Participants in this study will be young adults between the ages of 21-25, who regularly~     drink alcohol and are not currently seeking treatment for alcohol use. Seventy-two~     participants will complete this study.~   "
136482|NCT01780792|"~     Dance Dance Revolution (DDR) may offer an innovative and highly effective format for~     delivering exercise programs to people with multiple sclerosis (MS). It is a fun, engaging~     and interactive video game that requires players to move their feet to targets while matching~     the rhythm of a song. In addition, DDR, involving both aerobic exercise and cognitive~     training, is an ideal intervention for improving cognitive functioning in those with MS. The~     purpose of this pilot study is to examine the use of DDR as a novel and highly specific~     exercise intervention to improve mobility and cognition among individuals with MS.~   "
136483|NCT01780779|"~     The purpose of the study was to investigate whether functional MRI imaging (diffusion~     weighted imaging) is useful for monitoring the therapeutic response of bone sarcomas in~     children and young adults. All patients will be scanned before, during and after~     chemotherapy. The findings on MRI will be correlated with histological finding after surgery.~      Second purpose : to define apparent diffusion coefficient value of the bone sarcoma.~      Third purpose : to try define prognostic factors, to investigate if there is a correlation~     between early treatment response and outcome.~   "
136484|NCT01780766|"~     Whole body MRI with diffusion weighted imaging is a useful imaging tool~        -  staging and diagnosis~        -  therapy monitoring All patients will be scanned before and during treatment. The~          findings on diffusion weighted imaging will be correlated to the golden standard~          (computer tomography and MRI (T1 and STIR)).~   "
136485|NCT01780753|"~     The weight of malaria falls most heavily on young children and pregnant women but studies of~     the safety of antimalarials in pregnancy and lactation are few. The only recommended~     medication used for radical treatment of P.vivax is primaquine. The 2010 WHO malaria~     guidelines recommend its use in all patients with P.vivax infection in areas of low~     transmission, in the absence of contraindications. Primaquine is contraindicated in~     pregnancy. The postpartum period presents a key opportunity to definitively treat women who~     suffer multiple malaria relapses during pregnancy. The 2010 WHO malaria treatment guidelines~     allow for primaquine use during lactation but there are no studies to date quantifying~     primaquine excretion in breast milk and the dose that breastfed infants would be exposed to~     is unknown. The investigators propose to study the pharmacokinetics of primaquine in maternal~     and infant plasma and in breast milk during a 14 day radical treatment of P.vivax.~      Some inferences about the expected behavior of primaquine in lactation can be drawn from its~     known pharmacologic properties. Primaquine pharmacokinetics have been well characterized in~     healthy subjects and malaria patients after single and multiple oral dosing. Peak~     concentrations are reached within 2-3 hours after dosing and the plasma elimination half-life~     is ~7 hours. It is extensively distributed in the tissue and largely metabolized to inert~     carboxyprimaquine, the major plasma metabolite, which undergoes further biotransformation to~     unknown metabolites that are probably more toxic than the parent compound. The identification~     of other metabolites in humans has been difficult to pursue because the expected aminophenol~     metabolites are unstable.~      No pharmacokinetic studies have been done to measure primaquine excretion in breast milk. A~     few studies have been done of other antimalarials during lactation and have shown low levels~     of drug in breast milk during treatment.~   "
136486|NCT01780740|"~     Patients with coronary artery disease are often prescribed drugs called statins because~     research has shown that, by lowering cholesterol, they reduce the risk of having a heart~     attack or other complications in the long-term. Experimental studies have suggested that~     statins may also have rapid anti-inflammatory, anti-oxidant and anti arrhythmic actions;~     however, whether these effects are of any benefit to patients remains to be proven. The~     purpose of STARR trial (Statin Therapy in Atrial Refractoriness and Reperfusion injury) is to~     evaluate whether a short course of a commonly used statin (atorvastatin, 80 mg once a day)~     decreases inflammation and stabilises electrical properties of the upper chamber of the heart~     in the post operative period of patients undergoing cardiac surgery on the heart-lung machine~     either for valve replacement and/or coronary artery bypass grafting. It will also examine~     whether this treatment can protect the heart from sustaining tissue damage when blood supply~     is restored after a period of ischaemia during the course of the surgery.In addition it will~     also explore the impact of this intervention on biology of the vessels used for bypass~     surgery and the fat tissue in the vicinity of the heart & blood vessels.~   "
136487|NCT01780727|"~     Elderly patients are the fastest growing surgical population and present with increased risk~     of postoperative cardiac problems, especially congestive heart failure. Diastolic dysfunction~     is common in the elderly population and increases the risk of major adverse cardiac events~     after surgery. This project will use dynamic measurements of diastolic filling pressures by~     echocardiography for goal-directed fluid and drug management during surgery to determine~     whether this reduces serious cardiac events related to diastolic dysfunction after surgery in~     this high-risk population.~   "
136488|NCT01780714|"~     The goal of this exploratory study is to evaluate the effect of a candidate modified risk~     tobacco product (MRTP), THS 2.1, on selected biomarkers of exposure to harmful and~     potentially harmful smoke constituents (HPHCs), compared to conventional cigarettes (CC). The~     subjective effects (urge to smoke and withdrawal symptoms) which are related to the use of~     this product will be explored. Initial information on safety and on some biological effects~     when using THS 2.1 will be collected. Human Smoking Topography (HST) will be explored.~   "
136489|NCT01780701|"~     A prostate cancer diagnosis starts a list of events that often leads to fast-moving~     treatment, thought by many to result in vast over-treatment of this disease. So, discovery of~     different diagnostic methods that allow clinicians to identify slow-growing from potentially~     fast-growing disease prior to or at the time of prostate biopsy could result in early and~     suitable treatment for men at greatest risk, while greatly decreasing the number of biopsies,~     surgical procedures, hormonal and chemotherapeutic treatments, cost, and patient worry, for~     those with more slow-growing disease.~   "
136490|NCT01780688|"~     The main goal of this exploratory study is to evaluate the pharmacokinetic profile of~     nicotine for the candidate modified risk tobacco product THS 2.1 and for conventional~     cigarettes (CC).~   "
136491|NCT01780675|"~     Using Intensity Modulated radiotherapy it is possible to treat the entire brain to standard~     dosages of whole-brain radiation, while keeping the radiation dose to the hippocampus low.~     However, a clear relationship between radiation dose and damage to the hippocampal stem cells~     has not been established yet.~      This study is initiated to investigate the early and delayed neurotoxicity of PCI and to~     assess in a randomised design the benefits and risks of sparing the hippocampus in Small Cell~     Lung Cancer patients who receive PCI.~   "
136492|NCT01780662|"~     This phase I/II trial studies the side effects and the best dose of brentuximab vedotin when~     given together with gemcitabine hydrochloride and to see how well they work in treating~     younger patients with Hodgkin lymphoma that has returned or does not respond to treatment.~     Monoclonal antibodies, such as brentuximab vedotin, may find cancer cells and help kill them.~     Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop~     the growth of cancer cells, either by killing the cells or by stopping them from dividing.~     Giving brentuximab vedotin together with gemcitabine hydrochloride may kill more cancer~     cells.~   "
136493|NCT01780649|"~     Intracytoplasmic Morphologically Selected Sperm (IMSI) is a modification of IntraCytoplasmic~     Sperm Injection (ICSI) with a choice of the spermatozoon to be injected done at a 6000x~     magnification instead of 400x commonly used in ICSI. The purpose of this study is to evaluate~     the efficiency and the indications of IMSI through a multicentric randomised trial.~   "
136494|NCT01780636|"~     Non-relaxing puborectalis syndrome (NRPS) is an obstructive defecatory disorder that presents~     with chronic constipation, anismus, or a sensation of incomplete rectal emptying. The~     specific etiology of this syndrome is unknown. The true incidence of NRPS is unknown, but it~     is estimated that 4% of patients with defecatory disorders have NRPS. Previous therapies for~     non-relaxing PRS have included biofeedback, pelvic floor physical therapy, dietary changes,~     laxatives, enemas, and surgical division of the puborectalis muscle. Unfortunately, responses~     to these treatments have been variable at best. Direct injection of botulinum toxin (Botox)~     into the puborectalis muscle is an alternative approach for treating NRPS and has recently~     been reported in a limited number of studies. Botox blocks cholinergic nerve endings in the~     autonomic nervous system and has been used to weaken the puborectalis muscle in constipated~     patients.~      Our study aims to determine the efficacy of ultrasound and EMG guided Botox injections into~     the puborectalis muscle in women with NRPS. With use of this technique, we believe we will~     find that Botox injections decrease symptom severity and improve quality of life (QOL) in~     patients with NRPS.~      We plan to compare patient reported symptoms, symptom severity, and QOL prior to Botox~     injections with symptoms and QOL at 2-week, 3-month, and 6-month intervals after Botox~     injection into the puborectalis muscle in patients with NRPS.~      All enrolled patients will receive ultrasound and EMG guided Botox injections at three points~     along the puborectalis muscle. Post-injection data will be obtained with a defecation diary~     and questionnaire data at the 2-week, 3-month, and 6-month intervals. Additional injections~     will be offered to patients who fail the initial treatment.~   "
136495|NCT01780623|"~     Cancer-related fatigue is one of the most common and distressing symptoms associated with a~     cancer diagnosis.Fatigue related to cancer often appears before a diagnosis, worsens during~     treatment, and lasts for years after treatment in up to 35% of patients. Despite the~     long-term effects of cancer-related fatigue, the treatment options available are not always~     appropriate or helpful for all patients.Light therapy is an effective treatment for other~     disorders related to fatigue. The purpose of the study is to investigate the role of light~     therapy on quality of life, sleep patterns, and physical measures of immune function and~     stress hormones in individuals with post-treatment cancer-related fatigue.~   "
136496|NCT01780610|"~     There are two main cycle regimens used for endometrial preparation for frozen embryo transfer~     （FET) in women with irregular cycles: hormone replacement therapy cycles (HRT) in which the~     endometrium is artificially prepared by estrogen and progesterone hormones with/without a~     gonadotrophin releasing hormone agonist (GnRH-a) down regulation, and ovulation induced~     cycles (OI) in which follicular development is supported with increasing doses of~     gonadotrophin hormones and ovulation is induced. At present, there is still no sufficient~     evidence that which kind of frozen embryo transfer cycle regimen to plan more advantage. The~     purpose of this study was to compare the pregnancy outcome of hormone replacement therapy~     cycles (HRT) and ovulation induced cycles (OI) in women with irregular cycles.~   "
136497|NCT01780597|"~     The main question to be asked in this study is what is the potential for human hearts that~     have been deemed unacceptable for transplant, to be explanted and re-animated in a~     controlled, external environment to be assessed? Furthermore would the reanimated hearts be~     able to undergo improvement in their function in this external environment.~      Ultimately this may lead to an increase the number of hearts available for transplantation.~   "
136511|NCT01780415|"~     The objective will focus on the characterization of DNA fragments present in Blastocoele~     fluid, and the evaluation of these fragments as potential target for Preimplantation Genetic~     Diagnosis. To reach this goal, real-time PCR, Whole Genome Amplification techniques and~     -subsequently- Next Generation Sequencing and aCGH approaches will be used.~   "
136498|NCT01780584|"~     Low triiodothyronine (T3) syndrome defines as decrease of T3 levels during critically ill.~     This decrease of T3 levels was observed after congenital heart surgery using cardiopulmonary~     bypass. Previous largest study,Triiodothyronine for Infants and Children Undergoing~     Cardiopulmonary bypass (TRICC) study showed T3 supplementation decreased time to extubation~     for infants less than 5 months undergoing cardiopulmonary bypass. Intravenous regiment was~     known effective in maintaining T3 levels during pediatric cardiac surgery. This drug~     preparation however is not commonly used in many countries due to the relatively high costs~     and/or the simple lack of availability. The use of oral T3 to treat postoperative low T3~     levels in pediatric patients has not been reported so far, although recent adult studies~     showed benefit in using oral T3 after cardiac surgery. The purpose of this study was to~     determine if oral T3 supplementation could prevent the decline of serum T3 in children less~     than 2 years of age undergoing congenital heart surgery using CPB.~   "
136499|NCT01780571|"~     The purpose of this study is to determine whether continuouse positive airway pressure~     (CPAP), during induction of anaesthesia in morbidly obese patients, result in higher levels~     of oxygen in the blood.~   "
136500|NCT01780558|"~     There are three main cycle regimens used for endometrial preparation for frozen embryo~     transfer（FET）: natural cycles (NC) with/without ovulation triggering, hormone replacement~     therapy cycles (HRT) in which the endometrium is artificially prepared by estrogen and~     progesterone hormones with/without a gonadotrophin releasing hormone agonist (GnRH-a) down~     regulation, and ovulation induced cycles (OI) in which follicular development is supported~     with increasing doses of gonadotrophin hormones and ovulation is induced. At present, there~     is still no sufficient evidence that which kind of FET cycle regimen to plan more advantage.~     The purpose of this study was to compare the pregnancy outcome of NC-FET to that of HRT-FET~     in women with regular cycles.~   "
136501|NCT01780545|"~     This is a randomized, open-label Phase 2 clinical trial to evaluate whether suppression of~     Hsp27 (Heat shock protein 27) production using OGX-427, a second-generation antisense~     oligonucleotide (ASO), in combination with docetaxel can prolong survival time compared to~     docetaxel alone in participants with locally advanced or metastatic urothelial carcinoma (UC)~     that are relapsed or refractory after receiving a platinum-containing regimen.~   "
136502|NCT01780532|"~     After locating the suspicious lesion/mass with standard of care mammography and/or~     ultrasound, a photoacoustic scan will be performed in the breast where the lesion is located.~     After the PA scan a biopsy will be performed, if clinically indicated (based on the mammogram~     and ultrasound only).~   "
136503|NCT01780519|"~     The investigators' goal is to determine if certain tests of memory and attention, performed~     while sleepiness is induced by a single dose of lorazepam, can predict whether or not an~     individual is at risk for developing Alzheimer's disease.~   "
136504|NCT01780506|"~     This study will evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir~     alafenamide (Genvoya®; E/C/F/TAF) fixed-dose combination (FDC) versus~     elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF)~     FDC in HIV-1 positive, antiretroviral treatment-naive adults.~   "
136505|NCT01780493|"~     To evaluate the long term follow-up results of the direct nipple ureteroneocystostomy~     technique.~   "
136506|NCT01780480|"~     To evaluate the effect of the dynamic combination therapy on Chinese herbal granule formula~     (Fangji) based on differentiation of syndromes (Zhenghou) according to the theory of~     traditional Chinese medicine for improving the symptoms in the convalescent phase of ischemic~     stroke, and to establish the pharmacodynamic model of Zhenghou according to the results of~     this trial.~   "
136507|NCT01780467|"~     Use lay language.~      Many decisions involve the possibility of gaining or losing relative to the status quo. The~     loss aversion behaviour is a cognitive concept explaining that people are more sensitive to~     the possibility of losing objects or money than they are to the possibility of gaining the~     same objects or amounts of money.~      We hypothesised that dopamine could be involved in the loss aversion behaviour. To highlight~     this, we have chosen a model of dopaminergic depletion : the Parkinson's disease The primary~     purpose of this protocol is to study the role of dopamine in the loss aversion phenomenon by~     comparing brain activity in parkinsonian patient with and without treatment with L Dopa, when~     they are exposed to mixed (gain/loss) gambles using money.~      The second purpose is to highlight the role of a dopamine depletion by comparing patient~     without treatment vs healthy paired control.~      2 groups :~        -  20 parkinsonian patients (tested two times : with and without treatment by L dopa)~        -  20 healthy paired control~      Description of the protocol for patients :~      J0 : Inclusion visit (duration : 4h):~        -  motor assessment (UPDRS)~        -  neuropsychological and psychiatric assessment (MMS, MATTIS, BREF, Stroop, Ardouin scale,~          UPPS, MADRS, Hamilton, LARS).~      J0+1 day and J0 +2 days : 2 visits of MRI (magnetic resonance imaging) acquisition (with or~     without treatment) :~      Each acquisition was composed by an orientation sequence+ an anatomic sequence + a functional~     sequence.~      For healthy subjects, they have only one visit of 2 hours including a MMS, a MADRS and the~     MRI acquisitions.~   "
136508|NCT01780454|"~     This study will examine the safety and effectiveness of a combination kidney and bone marrow~     transplant from a haplo-identical related donor. An investigational medication and other~     treatments will be given prior to and after the transplant to help protect the transplanted~     kidney from being attacked by the body's immune system~   "
136509|NCT01780441|"~     The investigators are enrolling 3-12 month old infants with a diagnosis of tuberous sclerosis~     complex (TSC) for a new study on early markers of autism. The study is looking for early~     signs for autism in a population (TSC) where autism is common. The goal of this project is to~     use behavioral testing, MRI and EEG techniques to identify children at risk for developing~     autism starting at 3 months of age and continuing until 36 months of age. Throughout the~     study, the investigators will recommend Early Intervention services for any child who shows~     early signs of autism.~   "
136510|NCT01780428|"~     This is a double-blind, randomized, multiple-dose, placebo- and positive-controlled study of~     CL-108 (hydrocodone 7.5 mg/APAP 325 mg, promethazine 12.5 mg) in patients with moderate to~     severe pain following surgical removal of impacted third molar teeth.~      A positive control ( Norco, a commercial formulation of hydrocodone 7.5 mg/APAP 325 mg) was~     included to determine the anti-emetic effects of CL-108. The efficacy of CL-108 was also~     evaluated to placebo for the relief of pain.~   "
136514|NCT01780376|"~     Whole Body Vibration (WBV) applies thrust force in opposite direction to gravity to body.This~     mechanical stimulation induces reflex muscular activity. Tonic vibration reflex (TVR) is most~     commonly cited mechanism to explain WBV-induced reflex muscular activity (WBV-IRMA), although~     there is no conclusive evidence that TVR occurs. The bone myoregulation reflex is another~     neurologic mechanism used to explain the effects of vibration on muscular performance.~      Investigators hypothesized that latency of WBV-IRMA is different from latency of TVR. Primary~     aim of this study is to determine latency of WBV-IRMA. Secondary aim is to investigate~     whether WBV-IRMA is explained with TVR.~      Twenty healthy young adult men are planned to include in this study. Participants will stand~     upright with their knees locked during WBV. PowerPlate Pro5 will be used for WBV. WBV with~     high amplitude at 25,30,35,40,45 and 50 Hz will be applied. Surface electrodes will be placed~     on both the soleus muscles. To measure TVR latency, piezo-electric accelerometer will be~     placed on the achilles tendon and this achilles tendon will be stimulated with spring based~     mechanical reflex hammer. Our pilot study was showed that motor unit potentials (MUAP)~     occurred in a 1:1 response with vibration. After confirmation of this finding, WBV-IRMA~     latency will be measured in the present study. To measure WBV-IRMA latency, piezo-electric~     force sensor will be placed between heel and WBV platform. Exact moment of initial strike of~     heel when thrust force expressed by WBV begin to be transferred to body will be determined.~     The time between moment of the initial strike and corresponding MUAP is defined as WBV-IRMA~     latency. Piezo-electric stretch sensor will be placed between knee and malleol to simulate~     muscle spindle. The reflex muscle activity of soleus muscles will be measured by PowerLab~     (data acquisition system, ADInstruments, Australia) device.~      This project is planed to be completed in 1 months.~   "
136515|NCT01780363|"~     Background: Genetics is suggested to play a critical role in the development of Behçet's~     disease (BD). Shared phenotypic features requires an approach to the differential diagnosis~     from periodic febrile syndromes particularly from mevalonate kinase deficiency related~     diseases. We planned to study for evaluating the frequency of mutations and their clinical~     significance in mevalonate kinase gene in Turkish patients with Behçet's disease.~   "
136516|NCT01780350|"~     This study is attached to a comprehensive quality assurance/quality improvement (QA/QI)~     program conducted by the Office of the medical director, and is designed to contribute to~     generalizable knowledge to determine effectiveness and tolerability of an FDA approved~     Impedance Threshold Device (ITD) device in a large urban emergency medical service (EMS)~     system. The cohort will comprise a convenience sample of patients that are being treated by~     EMS for a hypotensive emergency.~   "
136517|NCT01780337|"~     In this pilot study the investigators will perform a double-blind randomized trial of~     intranasal oxytocin on measures of cardiac refractoriness, among individuals who are~     undergoing clinically indicated catheter ablation procedures for paroxysmal atrial~     fibrillation. The investigators seek to enroll 20 patients for this study, for the purpose of~     estimating effect sizes for a larger future study.~   "
136518|NCT01780324|"~     Primary Aim~      1. To measure difference in pain via Faces, Legs, Activity, Cry and Consolability (FLACC)~     Pain Scale score at the time of transurethral bladder catheterization for urine collection in~     children who do and do not receive intraurethral 2% lidocaine jelly prior to catheterization.~      Secondary Aims~        1. To assess gender differences in pain control during transurethral bladder~          catheterization with and without pain control using intraurethral 2% lidocaine jelly.~        2. To assess patient discomfort with administration of intraurethral 2% lidocaine jelly.~           To assess parental impression of discomfort between intervention and control groups.~        3. To assess pain associated with the administration of intraurethral 2% lidocaine jelly.~        4. To measure difference in pain via Modified Behavioral Pain Scale (MBPS) score at the~          time of TUBC for urine collection in children who do and do not receive intraurethral 2%~          lidocaine jelly prior to catheterization.~   "
136519|NCT01780311|"~     A randomized, parallel, open study comparing catheter ablation versus antiarrhythmic drugs~     for outflow tract ventricular arrhythmias~   "
136520|NCT01780298|"~     Chronic obstructive pulmonary disease (COPD) is a common inflammatory disease of the airway~     affecting approximately 10% of individuals aged 40 years or more with a smoking history. The~     disease is characterized by an increase in numbers of airway white blood cells (neutrophils,~     lymphocytes and monocytes). Stimulation of white blood cells results in the release of~     different agents of inflammation. Some of these agents give an indication of the presence or~     severity of a disease when measured.~      This case control study will be conducted at The Heart Lung Centre, London, UK. The study~     aims to determine biomarkers for the differentiation of subjects with COPD (GOLD Stage 1-2~     and who are current smokers with a ≥ 10 pack year smoking history) and three matched control~     groups: one of non-smoking subjects (never smoked), one of ex-smokers and one of current~     smokers. COPD subjects will be matched to the non-COPD subjects by gender, age and ethnicity.~      The study will include a range of physiological measurements including lung function,~     computerized tomography scans (CT scans), cardio pulmonary exercise test and computerized~     multichannel lung sounds analysis (Stethographics). In addition, lung inflammation will be~     assessed by cellular and molecular biomarkers using e.g. transcriptomics and proteomics~     technologies.~   "
136521|NCT01780285|"~     This study is prospective randomized trial enrolling at least 50 participants which compares~     efficacy and safety of two alternative methods of laparoscopic hiatal repair for giant (i.e.~     with hiatal surface area (HSA) exceeding 20 sq.cm) types II and III hiatal hernias: partially~     absorbable lightweight mesh repair, and nitinol-framed lightweight polytetrafluoroethylene~     (PTFE) mesh repair. In the literature, mean rate of anatomical recurrence of giant hiatal~     hernias is 25 %, reaching 42 %. Polypropylene and composite PTFE meshes used most widely,~     result in unacceptable rates of long-term dysphagia (10-15 %) and oesophageal strictures. Own~     experience of the interventors of more than 400 repairs using partially absorbable~     lightweight mesh Ultrapro (Ethicon) and original sub-lay technique of its fixation precluding~     contact of the mesh with the oesophagus, showed low recurrence rate for large hernias and a~     few cases of long-term dysphagia. For giant hiatal hernias, this technique provides~     acceptable results (20 % of recurrence) which correspond to the literature. Nevertheless,~     these results may be improved, probably by using of new type of prosthesis. Thus, in~     collaboration with Minnesota Medical Development, Inc., USA, the interventors created~     fundamentally new method of hiatal repair by using new prosthesis - Rebound HRD-Hiatus~     hernia. This prosthesis is heart-shaped lightweight PTFE mesh with peripheral nitinol frame.~     It is easily fixated to the crura posteriorly to the oesophagus completely covering hernia~     defect, and supports a strong framework of the hiatus, and, therefore, allows to save a~     principle a real tension-free repair. Mid-term results (mean follow-up period of 15 months)~     of 29 procedures showed no recurrences or oesophageal complications. Naturally, final~     conclusions regarding superiority of the new technique could be established by prospective~     randomized study. The hypothesis of the current trial is: new method of nitinol-framed~     lightweight PTFE mesh repair is more effective in terms of recurrence rate compared to~     sub-lay partially absorbable lightweight mesh repair, and is characterized by at least~     similar safety in terms of oesophageal complications. The long-term results (24 months post~     surgery for every patient) will be studied using symptom questionnaires, quality of life and~     satisfaction questionnaires, barium studies, endoscopic examinations, 24-hour pH testing, and~     analysis of possible reoperations.~   "
136522|NCT01780272|"~     This trial is conducted in Europe. The aim of this trial is to investigate the impact of low~     blood sugar during the night on sleep in subjects with type 2 diabetes.~   "
136523|NCT01780259|"~     The primary purpose of the study is to evaluate the pharmacokinetics (what the body does to~     the medication) of intranasally (through the nose) administered esketamine in healthy~     participants.~   "
136524|NCT01780246|"~     The primary objective of this study is to examine the safety and tolerability of nusinersen~     (ISIS 396443) administered intrathecally to participants with Spinal Muscular Atrophy (SMA)~     who previously participated in ISIS 396443-CS1 (NCT02865109). The secondary objective was to~     examine the plasma pharmacokinetics of a single dose of ISIS 396443 administered~     intrathecally to participants with SMA who previously participated in ISIS 396443-CS1.~   "
136525|NCT01780233|"~     The objective of this study was to compare the rate of absorption and bioavailability of~     fentanyl 400 µg sublingual spray, Actiq® 400 µg transmucosally, and fentanyl citrate~     injection 100 µg intravenously.~   "
136526|NCT01780220|"~     As there is no prospective data on the combination of abiraterone and salvage radiotherapy,~     the aim of this study is to further evaluate the safety profile of abiraterone acetate plus~     prednisone in patients with prostate cancer who are biochemically relapsing after surgery and~     undergo salvage radiotherapy with 6-months LH-RH agonist.~      The investigators hypothesize that the toxicity profile of both treatments should not~     potentiate each other. This study will also provide preliminary data on the efficacy of this~     combination.~   "
136527|NCT01780207|"~     The purpose of this study in patients with obstructive sleep apnoea (OSA) and concomitant~     patent foramen ovale (PFO) is to assess the impact of percutaneous PFO closure on nocturnal~     hypoxemia and apnea/hypopnea, pulmonary and systemic artery pressure, endothelial function~     and arterial stiffness.~   "
136528|NCT01780194|"~     -  To determine the effect size of lumbar fusion measured by Oswestry Disability Index and~          compared with conservative treatment in patients with chronic low back pain.~        -  Meta-analysis using fixed effect model synthesis method.~        -  Included studies were retrieved from Medline and Cochrane CENTRAL databases since 1990.~   "
136529|NCT01780181|"~     The purpose of this study is to observe the efficacy of chemotherapy combined with~     Traditional Chinese Medicine for elderly patients with advanced non-small-cell lung cancer,~     also to evaluate the adverse reaction and the reliability.~   "
136530|NCT01780168|"~     Background:~      - Inborn errors of metabolism (IEM) can affect how the body s immune system functions. People~     with IEM also have special dietary restrictions that may affect the function of their immune~     system. Researchers want to better understand how having an IEM may affect immune system~     function.~      Objectives:~      - To study the how having an IEM may affect immune system functioning.~      Eligibility:~        -  Individuals at least 2 years of age who have an IEM.~        -  Healthy volunteers at least 2 years of age.~      Design:~        -  Participants will come to the NIH Clinical Center for at least 1 evaluation. Depending~          on the level of participation, participants may return for additional visits. All~          participants (or their parents) must keep a detailed food diary for 3 days before the~          initial visit.~        -  At the study visit, participants will provide blood samples. Females of childbearing age~          will provide a urine sample.~        -  Participants will be offered the hepatitis A vaccination if not already given. If the~          visit occurs during flu season (roughly September through March), they will be offered a~          seasonal/H1N1 influenza vaccine.~        -  Children between 2 and 8 years of age may require booster shots depending on their~          history of vaccination.~        -  At a follow-up visit(s), participants will provide additional blood samples.~        -  Participants may return yearly for their flu vaccine.~   "
136531|NCT01780155|"~     Background:~      - Some premature babies develop bronchopulmonary dysplasia (BPD) and retinopathy of~     prematurity (ROP). BPD and ROP are long-term chronic diseases of the lungs and eyes,~     respectively. BPD is associated with receiving mechanical ventilation to treat respiratory~     distress syndrome, and causes lung inflammation and scarring. ROP is caused by poor~     development of blood vessels in the eyes, and may lead to blindness. Because not all~     premature babies develop BPD or ROP, researchers want to study the genes that could be~     associated with these diseases. They will look at both premature infants and their parents to~     see if there is a genetic component to BPD and ROP.~      Objectives:~      - To study genes that may be associated with BPD and ROP.~      Eligibility:~        -  Premature babies born with a weight less than or equal to 1,250 grams.~        -  Parents of the premature babies.~      Design:~        -  Parents will answer questions about the mother s health and pregnancy.~        -  Delivery and medical information will be collected during the baby s hospitalization for~          the first month after birth.~        -  Parents will provide a saliva sample from the inside of the cheek.~        -  A saliva sample will also be collected from the baby within 28 days of birth. If the~          baby needs tracheal aspiration (removal of fluid from the throat), tracheal fluid~          samples will also be collected.~        -  Parents will have followup interviews about their child s health 6 months, 12 months,~          and yearly for up to 6 years after birth.~        -  This is a genetic study only. Treatment will not be provided as part of this study.~   "
136532|NCT01780142|"~     Background:~      - Asthma is a lung condition that causes difficulty breathing and decreased lung function.~     Some people with asthma have more severe disease symptoms. They may be less responsive to~     standard treatments such as steroids. Researchers want to compare severe asthmatics with mild~     or moderate asthmatics or people without asthma over a long period. This information may help~     identify new treatments for people whose asthma is not well controlled by standard~     medications.~      Objectives:~      - To compare severe asthmatics with mild or moderate asthmatics, and healthy volunteers, to~     study the progression and outcomes of the disease.~      Eligibility:~        -  Individuals at least 18 years of age who have been diagnosed with asthma for at least 1~          year.~        -  Healthy volunteers at least 18 years of age.~      Design:~        -  This study will involve an initial visit to the NIH Clinical Center for all~          participants. Selected participants may be asked to return for repeat visits over a~          number of years. The test results from participants with asthma will be compared with~          those from the healthy volunteers.~        -  All participants will be screened with a physical exam and medical history.~        -  Participants may (but will not necessarily) have the following tests at each visit:~        -  Complete medical history and physical exam~        -  Blood, urine, sputum, and nasal cell samples~        -  Breath tests and heart and lung function tests~        -  Six-minute walk test to measure ability to exercise~        -  Imaging studies such as chest x-rays, bone density scans, and sinus scans~        -  Allergy skin testing~        -  Vocal cord exam~        -  Overnight sleep study~        -  Participants may remain on the study for as long as they are willing to participate and~          do not develop health problems that will interfere with the study.~   "
136572|NCT01779609|"~     The purpose of this study is to establish the effect of ET blockade on vascular adaptations~     during an 8-week exercise program in subjects with T2DM. We hypothesize that combining ET -~     blockade with exercise training leads to an acute increase of exercise induced blood flow~     when compared with exercise alone. We expect that this will lead to an optimization of~     vascular training effect in T2DM.~   "
137301|NCT01770067|"~     Following previous positive experience with CITA-RNPT of infected pacemakers, we suggest that~     CITA-RNPT can be administered prophylactically to patients prior to replacement of CIED,~     immun-compromised patients, and others.~   "
136533|NCT01780129|"~     HW6 can prolong animal's survival time and increase the survival rate. HW6 enhances cardiac~     function, improves microcirculation, and increases blood pressure and pulse pressure, and~     improves blood perfusion of important organs; HW6's anti-shock activity comes from a combined~     multiple target pharmacological effects.~      Based on a completed phase II trial conducted in China, HW6 can effectively treatment shock~     patient.~      This is a phase II clinical study to further evaluate the efficacy and safety of Polydatin~     Injectable 100mg/5mL/via (HW6) in the treatment of shock in the United States. Patients with~     traumatic/hemorrhagic shock or septic shock admitted to the emergency room or ICU with~     systolic blood pressure < 90mmHg, or is on vasopressor(s) for systolic blood pressure~     stabilization, regardless the types of completed, on-going, or projected Standard of Care or~     surgery will be recruited to participant in the trial. A total of 120 patients with~     traumatic/hemorrhagic shock and 120 patients with septic shock will be enrolled. For each~     type of shock, sixty patients each will be in test group and control group. Both adult males~     and females aged 18-80 years are eligible. The primary clinical endpoint is the time length~     (TL) between the start of HW6 administration to the onset of the first treatment success,~     that is: the systolic blood pressure is stabilized at ≥90mmHg and MAP≥65mmHg for 1 hour~     without the use of vasopressors. Several secondary endpoints and biomarkers will be measured.~      Efficacy data will be compared using group t-test or Wilcoxon log-rank test between treatment~     groups and placebo groups. Safety data will also be reported accordingly.~   "
136534|NCT01780116|"~     When compared with those in the control (usual care) group, participants in the AT group are~     expected to demonstrate significant improvements immediately and at three, six and 12 months~     after completion of the intervention in: level of medication adherence, readmission rate,~     mental status, insight into treatment, and level of functioning.~   "
136535|NCT01780103|"~     In this retrospective study the investigators will enroll newborns that were born between~     01.01.2010 and 31.12.2012 in Hillel Yaffe Medical Center with the prenatal diagnosis of~     Pyelectasis according to prenatal sonographic screening test.~      These babies underwent renal sonography at the age of 2-5 days according to the protocol and~     were invited to an additional renal sonographic screening test at the age of 1 month.~      The investigators will compare the results of the 2 examinations and the investigators will~     try to reach conclusions whether there is correspondence between the severity of the~     pyelectasis in the first and second sonographic tests and the outcome of these newborn babies~   "
136536|NCT01780090|"~     The proposed study will result in a software application compatible with the Apple iPad,~     iPhone and iPod Touch (hereafter termed iOS devices) which addresses several aspects of~     prosodic deficits common in speakers with Autism Spectrum Disorders (ASDs) and other~     communication disorders, using a developmentally appropriate, intuitive interface that~     requires little technical skill and which can be managed by educators and parents. The~     program will contain elements that aid in tracking and maintaining individual student~     progress records, and will be designed for use in the classroom, at home, and in other~     environments. This study's intended focus is on the feasibility and usability of the software~     application.~   "
136537|NCT01780077|"~     The purpose of this trial is to evaluate the safety and tolerability of multiple (3)~     intradermal doses of RXI-109 at small surgical incisions in the abdominal skin of healthy~     volunteers. The effect of RXI-109 versus placebo on scarring at these incision sites will be~     evaluated visually, histologically, and by biomarker analysis.~   "
136538|NCT01780064|"~     The purpose of this study is to compare the effect of early individualized psychosocial~     assets versus a standard support on social inequalities in the rate of return to work~   "
136539|NCT01780051|"~     This is a phase-1, single center, open-label, randomized, single-dose, 2-way crossover study.~     The objective of the study is to compare the pharmacokinetic properties after~     co-administration of Repaglinide 2mg and Metformin hydrochloride 500mg with administration of~     combination preparation of Repaglinide 2mg and Metformin hydrochloride 500mg in 50 healthy~     male volunteers.~   "
136540|NCT01780038|"~     Innovative strategies to reduce adult smoking prevalence include using genetic information to~     motivate cessation and, ultimately, to tailor cessation pharmacotherapy. Success of these~     interventions depends, in part, on smokers' interest and participation in genetic testing~     related to cessation and their understanding and use of the results (i.e., their genetic~     literacy). The recent availability of genetic risk testing for a nicotinic acetylcholine~     receptor gene (CHRNA3) variant (rs105173) associated with nicotine dependence makes it highly~     feasible to investigate smokers' interest in and use of genetic information about nicotine~     dependence. Therefore, the primary purpose of this study is to determine the impact of an~     intervention that provides smokers with an educational session about genetic contributions to~     smoking and nicotine dependence plus their genotype results for rs1051730 on smoking~     cessation outcomes compared to those who receive only the educational session. Secondary~     purposes are to determine: (a) the impact of genetic education and knowing personal genotype~     results on genetic literacy outcomes and (b) the feasibility of recruitment and retention~     methods in a study addressing genotyping for nicotine dependence. Primary outcomes are~     cessation-related behaviors and cognitions indicating abstinence. Secondary outcomes are~     cognitions and emotions indicating genetic literacy. Knowledge gained from this study has the~     potential for clinical translation so that as genotyping becomes part of smoking cessation,~     health-care providers can understand and address factors influencing smokers' adaptation to~     genetically-informed cessation treatment. The study will use a longitudinal, repeated~     measures design (experimental, control; N=90; 45/group). All participants will receive a~     90-minute educational session about genetic contributions for smoking and nicotine dependence~     and will donate a buccal swab sample for genotyping. The investigators will then randomize~     participants to two groups: those who receive genotyping results in a genetic counseling~     session (experimental) and those who do not (control). Follow-up data will be collected from~     both groups at baseline and weeks 2, 6, 10 after the experimental group receives genotyping~     results, with a brief follow-up and study termination occurring at week 12. Control group~     participants will be offered their genotyping results at the end of the study.~   "
136541|NCT01780025|"~     The purpose of this study is to measure objectively the coupling from direct acoustic~     cochlear stimulation to the inner ear with a non-invasive technique of auditory evoked~     potentials.~   "
136566|NCT01779687|"~     Dyslipidemia is highly prevalent among patients with HIV infection and contributes to the~     increased cardiovascular disease risk in this patient population. Atorvastatin lowers plasma~     low-density lipoprotein (LDL) cholesterol levels and is used for prevention of~     artherosclerotic disease. Raltegravir, an HIV integrase inhibitor, could be one of the~     preferred antiretroviral agents in HIV patients with dyslipidemia because it has a beneficial~     lipid profile.~      Theoretically, no clinically relevant drug interaction is expected between atorvastatin and~     raltegravir. However, atorvastatin and raltegravir share similar metabolic pathways which~     could be relevant in the occurrence of pharmacokinetic interactions. In order to be able to~     recommend raltegravir and atorvastatin concomitant use, a pharmacokinetic study in healthy~     volunteers is proposed.~   "
136567|NCT01779674|"~     This study´s aim is to collect scientific data about patients with atrial inflammation by two~     principles of sensors measuring congestive heart failure.~   "
136616|NCT01779037|"~     IRF-PAI Functional Outcomes Data, including FIM instrument variables~   "
136542|NCT01780012|"~     Osteoporosis is a disease characterized by reduced bone mass and increased skeletal~     fragility, predisposing to an increased fracture risk. The presence of a low trauma fracture~     is a powerful predictor of future fractures and about 50% of patients with a fragility~     fracture will suffer a subsequent fracture in the next 10 years (Center Jacqueline R, 2007).~     Osteoporotic fractures are associated with an increased morbidity and mortality but also high~     financial costs. However, less than 20% of patients presenting a low trauma fracture receive~     an appropriate post-fracture osteoporosis management (Little and Eccles, 2010). The~     hypothesis of a lack of information and an under assessment of consequences by both patients~     and physicians has been raised to explain this gap between recommended care and usual~     practices.~      The aim of the PREVOST program is to assess the efficiency of patient-centered osteoporosis~     prevention program, after a fragility fracture of the upper limb, to improve post-fracture~     management of osteoporosis (ie BMD test and / or osteoporosis treatment) in women over 50~     years old.~      This open randomized controlled trial aims to compare the BMD or osteoporosis treatment~     prescription rate at 6 months after inclusion between two groups: intervention receiving~     information on fracture and osteoporosis (oral and written), phone call reminders and written~     information to give to their family physician, and control receiving usual care without~     information.~   "
136543|NCT01779999|"~     Background: PICC-related thrombosis have shown a slightly different pattern of frequency and~     risk factors, compared with traditional CVC; because of the increasing diffusion of PICCs,~     they are becoming a somehow independent pathology, still under investigation; no~     pharmacological prevention has proved to be effective. Aim of this study is to estimate the~     cumulative incidence of thrombosis in a cohort of patients carrying a PICC-line CVC,~     monitored to allow an early detection and prevention of complications related to the presence~     of asymptomatic deep venous thrombosis, and to explore the role of several potential risk~     factors.~      Methods: in a prospective observational cohort we will enroll 150 consecutive patients having~     a PICC inserted by our team; clinical characteristics, comorbidities and main features of~     catheter positioning procedure will be registered; patients will be followed with clinical~     and echographic scheduled controls, weekly for the first month, then monthly; patients with~     PRDVT will be treated with LMWH and recontrolled weekly until removal of catheter~   "
136544|NCT01779986|"~     The use of CT Coronary Angioscan (CT-AS) is gaining popularity, but its exact value as~     evaluation of CAD requires confirmation. We intend to compare the results of CT-AS and~     convention coronary angiogram results in patients who are scheduled for an ascending aorta~     aneurysm reparation surgery. These examens are standard of care before this surgery, so there~     is no additional danger or disadvantage for the patient. We hope to confirm that CT-AS is a~     reliable screening test for CAD in patient undergoing heart surgery for other reason than~     CAD.~   "
136545|NCT01779973|"~     The goal of this project is to test the feasibility, acceptability, and preliminary efficacy~     of using remote compliance monitoring in buprenorphine (Suboxone®) treatment for opiate~     dependence. To that end, 10 opiate dependent subjects will be recruited through the~     University of Pennsylvania's Treatment Research Center, an outpatient substance abuse~     treatment facility. All subjects will receive buprenorphine (Suboxone®) (16 mg/day, adjusted~     as needed according to individual requirements).~   "
136546|NCT01779960|"~     Up to this moment, the majority of studies assessing the level of physical activity in daily~     life in patients with COPD are limited to a cross-sectional design, which does not take into~     account natural variation of physical activity in daily life due to differences in climatic~     conditions faced throughout the year. Preliminary evidences suggest that patients with COPD~     have different physical activity levels according to the seasons of the year. However, the~     limited current evidences do not allow us to know the magnitude of differences in the level~     of daily physical activity in patients with COPD when taking into account climatic changes~     resulting from different seasons of the year in cities and countries with contrasting~     climatic conditions. This gap observed in the literature does not allow us at this moment to~     know whether we should or not consider the season of the year as one of the main causes of~     variability while assessing physical activity in daily life in patients with COPD.~      The present project proposes to investigate the hypothesis that patients with COPD who live~     in a place with less marked decrease in temperature between summer and winter (Londrina,~     Brazil) have less variability in the level of physical activity in daily life through the~     year in comparison to patients who live in a place with more marked climatic variability~     during these seasons (Leuven, Belgium).~   "
136547|NCT01779947|"~     The purpose of this study is to compare the safety and efficacy of generic Estradiol Vaginal~     Inserts, USP 10 mcg to the reference product Vagifem® 10 mcg and to determined whether the~     efficacy of each of the 2 active treatments is superior to that of the placebo.~   "
136548|NCT01779921|"~     This study is conducted globally. The aim of this study is to describe the treatment~     modalities and outcomes of bleeding episodes, surgery and prophylaxis in patients with factor~     VII (FVII) deficiency in addition to evaluate the presence (in already treated patients)~     and/or the appearance of inhibiting antibodies to FVII and/or therapy-related thrombosis.~      Due to a Novo Nordisk commitment to the Committee for Medicinal Products for Human Use~     (CHMP), Novo Nordisk receives data on treatment with activated recombinant human FVII~     (rFVIIa, NovoSeven®) in patients with FVII deficiency from the Seven Treatment Evaluation~     Registry (STER, NCT01269138). These patients can also have been treated with other~     haemostatics for systemic administration.~   "
136568|NCT01779661|"~     The objective of this research is to examine the effect of Infant Aquatics on the development~     of and neurodevelopment of preterm and near-term infants, using the GM as prognostic~     estimation of future development.~      Preterm infants, a continuously growing population, are at high risk for neurodevelopment~     impairments ranging from minor neurological dysfunction (MND) to cerebral palsy (CP), mainly~     due to developmental brain injury. Infant Aquatics have been found to benefit and promote~     infant development. The support and sensory stimulation of the water may improve the~     development the sensory, motor, as well as, autonomic system of preterm infants.~      The study will compare intervention by Infant Aquatics to infant massage. The intervention in~     both methods will start at 36 weeks gestational age for 3 months and will consist of sessions~     with a therapist every 2 weeks. Development will be assessed and compared at 3, 8 and 18~     months using Infant Motor Pattern method, Griffith developmental scales and Vineland adaptive~     behavior scales.~   "
136549|NCT01779908|"~     Prospective, randomized and placebo-controlled 6-month trial of vitamin D supplementation in~     130 Caucasian and vitamin D-deficient men and women aged 25 years and over. Participants will~     have abdominal obesity and at least one factor associated with insulin resistance.~     Participants will be randomized by sex, BMI and age. The primary aim is to compare the effect~     of daily vitamin D3 (cholecalciferol, 5000 IU) vs. placebo for 6 mo on insulin sensitivity~     (M-value by the gold standard method, the euglycemic hyperinsulinemic clamp). Secondary aims~     are to evaluate the effects of vitamin D3 vs. placebo on other indices of glucose metabolism,~     the lipid profile, blood pressure and anthropometric measurements. Questionnaires on physical~     activity and sunlight exposure, and a food frequency questionnaire will be administered at 0~     and 6 mo to adjust for confounding factors. At 0 and 6 mo, changes in serum 25(OH)D will be~     correlated with changes in blood markers associated with insulin sensitivity [hs-CRP,~     inflammatory cytokines (IL-6 and TNF-alpha), adiponectin, leptin, total and undercarboxylated~     osteocalcin].~      This research project intends to test 2 major hypotheses: (1) that vitamin D deficiency plays~     a causal role in the pathogenesis of insulin resistance in humans; and (2) that vitamin D~     increases insulin sensitivity.~   "
136550|NCT01779895|"~     The purpose of this study is to evaluate the efficacy of a probiotic strain in improving the~     quality of life in adult subjects suffering from perennial allergic rhinit.~   "
136551|NCT01779882|"~     The aim of this study is to test the hypothesis, that the order of application of Busulfan~     (BU) and Cyclophosphamide (CY) has an impact on toxicity after allogeneic Hematopoietic stem~     cell transplantation (HSCT) and that CY-BU reduces liver toxicity compared to BU-CY.~   "
136552|NCT01779869|"~     The objective for this pilot study is to develop an optimized, clinically usable myocardial~     PET-MR perfusion protocol and to determine which of all data potentially available should be~     acquired for a clinical myocardial perfusion examination. Hypothesis: The hypothesis is that~     high resolution, high sensitivity DCE MRI could replace the rest PET myocardial perfusion~     imaging, significantly decreasing examination time and patient radiation dose while~     maintaining the comprehensive reference-quality PET myocardial stress perfusion coverage.~      The primary outcome will be comparison of diagnostic accuracy of each combination of imaging~     to detect clinically significant coronary artery stenosis (≥70% diameter stenosis). The~     secondary outcome will be comparison of confidence for presence of disease among data sets.~   "
136553|NCT01779856|"~     The primary objective of this study is to estimate the proportion of hemodialysis patients~     experiencing clinically significant cardiac arrhythmias over a 6-month period using~     continuous cardiac monitoring with an implanted Medtronic Reveal Insertable Cardiac Monitor~     (ICM) device.~   "
136554|NCT01779843|"~     This research study is a Phase I clinical trial. Phase I trials test the safety of an~     investigational drug or combination of drugs. Phase I studies also try to define the~     appropriate dose of the investigational drug to use for further studies. Investigational~     means that the combination of drugs is still being studied and that research doctors are~     trying to find out more about it. As part of this research study, you will take alisertib in~     combination with idarubicin and cytarabine. Alisertib has not been approved by the FDA for~     your cancer. However, cytarabine and idarubicin have both been approved by the FDA for~     treatment of AML. It also means that the FDA has not approved giving alisertib with~     idarubicin and cytarabine for use in patients, including patients with your type of cancer.~      Idarubicin and cytarabine are chemotherapy agents that are commonly used to treat individuals~     diagnosed with AML. Alisertib has been used in laboratory studies and those studies suggest~     that alisertib may slow down the spread of your cancer. It does this by blocking certain~     substances needed by the cancer cells to spread. In this study, researchers would like to~     combine alisertib with standard chemotherapy (cytarabine and idarubicin) in order to see if~     it can be given safely with chemotherapy in individuals with AML.~      The primary purpose of this research study is to determine the highest dose that alisertib~     can be given with idarubicin and cytarabine without severe or unmanageable side effects. The~     dose identified in this study will be used in future research studies.~   "
136555|NCT01779830|"~     The aim of this study is to learn how different doses of LY2624803 affect sleep in healthy~     people. The study has four treatment periods. Participants will receive a single dose of~     LY2624803, another sleeping pill, or placebo in each treatment period. The study will last~     approximately 1 month for each participant.~   "
136556|NCT01779817|"~     1. MAIN OBJECTIVE :~           To assess the consequences of a maternal hyperthyroïd during pregnancy on intellectual~          development of the child from 6 to 9 years~        2. SECONDARY OBJECTIVES :~             1. To assess the consequences of a maternal hyperthyroïd during pregnancy on the~               capacities of attention, learning process and the degree of hyperactivity of the~               child from 6 to 9 years.~             2. To study if it exist differences of intellectual development, capacities of~               attention, learning process, and degree of hyperactivity in the child from 6 to 9~               years, born to hyperthyroid mother during pregnancy, according to:~                  -  the etiology of the maternal hyperthyroïd (transitory gestation hyperthyroid~                    versus disease of Basedow),~                  -  the use or not of a anti-thyroid treatment,~                  -  the rate of TSH néonatal (measured with the blotter by tracking with J3 at all~                    the new born ones).~   "
136569|NCT01779648|"~     Various kinds of intermittent pneumatic compression devices (IPC) with particular ways of~     compression have been developed and used for prevention of deep vein thrombosis.~      There are still some controversies about the physiologic properties and clinical impact of~     numerous issues including the variety of the cuff length, inflation rate, compression~     sequence, compression-relaxation cycle rate, and pressure generation characteristics.~      This study is designed to compare clinical efficacies as well as venous hemodynamic~     improvements between Simultaneous bilateral compression with fixed venous refill time versus~     alternate compression with adjusted refill time~   "
136570|NCT01779635|"~     The investigators hypothesize that the use of heparin-grafted membrane versus conventional~     membrane in critically-ill patients with bleeding-risk undergoing continuous renal~     replacement therapy, will effectively prolong the circuit lifespan, without worsening of the~     systemic APTT or underlying bleeding risk.~   "
136571|NCT01779622|"~     To test the influence of rapid versus slow ingestion of a mixed meal on insulin and incretin~     hormone secretion in healthy volunteers~   "
136557|NCT01779804|"~     Foot and ankle injuries account for nearly two million visits to Emergency Departments (EDs)~     in the United States and Canada each year. Of these injured patients, only 15% are diagnosed~     with actual fractures of the ankle. Due to such a small percentage, the Ottawa Ankle and~     Foot Rules (OFAR) were developed, which are a set of clinical decision-making guidelines~     that have been shown to be effective in diagnosing ankle and foot fractures. These rules are~     internationally accepted by the medical community, but are inconsistently applied.~      At Lehigh Valley Health Network (LVHN), the ED triage nurses are routinely trained in how to~     use the Ottawa Ankle and Foot Rules, but the rules are not always applied which may result in~     unnecessary X-rays. These guidelines are current network standard of care (usual,~     established care) that allow nurses to decide treatment for foot and ankle injury patients;~     in other words, whether to send these patients for an X-ray or not.~      The research staff is conducting this study in order to find out if using these~     nurse-directed guidelines--on a regular and consistent basis--can decrease the number of~     X-rays ordered, decrease patient waiting times/length of stay (LOS) and increase patient~     satisfaction with their care in the ED.~      STUDY PURPOSE:~      The two main goals of this study are to find out if use of the Ottawa Ankle and Foot Rules by~     triage nurses can decrease the amount of X-rays ordered in the ED, as well as LOS.~      Secondary study goals are to: 1) see how many X-rays are ordered by physicians and~     physicians' assistants after patients are evaluated by the Ottawa Ankle and Foot Rules as not~     having had a fracture; and 2) evaluate patient and provider satisfaction with the care~     provided both when the Ottawa Foot and Ankle Rules are used and when they are not.~   "
136558|NCT01779791|"~     The purpose of this study is to evaluate the efficacy and safety of PCI-32765 (ibrutinib)~     administered to patients with chemoimmunotherapy-resistant follicular lymphoma (FL).~   "
136559|NCT01779778|"~     The purpose of this research study is to determine the diurnal and nocturnal effects of~     Travoprost with SofZia (Travatan Z) on intraocular pressure and ocular perfusion pressure.~   "
136560|NCT01779765|"~     This study objective is to assess the short and long term effects of partially hydrolyzed~     guar gum (PHGG) administration on clinical symptoms of IBS and quality of life of these~     patients.~   "
136561|NCT01779752|"~     In human, the cerebral cortex forms a network of vestibular cortical areas which functional~     role remains unknown. In patients with localised cortical lesions the investigator has~     previously demonstrated that the parieto-temporal cortex could regulate the inertial~     component of the vestibulo-ocular (VOR) responses whereas more ventral regions including the~     temporo-occipital cortex would be associated with gain regulation of these VOR responses.~      The investigator's main purpose is to investigate the modalities of vestibular integration in~     these posterior parieto-temporal et temporo-occipital cortical regions. Thus, by using~     repetitive ttranscranial magnetic stimulation (rTMS) the investigator will induce a~     transitory inhibition of one of these 2 cortical regions and register its effect on VOR~     responses. Based on theta burst stimulation (TBS) paradigm, the investigator will stimulate~     the region of interest by applying on the scalp repetitive burst (at 50 HZ) during 44sec.~     Then, during the consecutive cortical inhibition lasting for the 15 minutes poststimulation,~     the investigator will record the subject's VOR responses. The VOR gain will be calculated and~     the time constant and phase will provide an estimation of the inertial component of the VOR~     responses. The healthy subjects recruited on the basis of inclusion criteria during medical~     examination will be divided into two groups of 20 subjects each depending of their sites of~     stimulation, temporo-parietal or temporo-occipital. Each subject will perform three~     experimental sessions (of 1h in average each) separated by at least one week and~     corresponding to : (1) the right cortical stimulation, (2) the left stimulation and (3) the~     vertex stimulation serving as the control session.~      The TMS paradigm is used in routine in hospital and research field and had very few negative~     consequences (mainly transitory and occasional headache).~   "
136562|NCT01779739|"~     This is a single center, double-blind, randomized controlled trial evaluating the change in~     sexual function in women undergoing vaginal repair for pelvic organ prolapse. Participants~     will be sexually active women who agree to randomization to having perineorrhaphy added to or~     excluded from their surgical repair. We hypothesize that sexual function will improve more~     significantly in women undergoing vaginal repair with perineorrhaphy.~   "
136563|NCT01779726|"~     Annually, 4,200 new cases of lung cancer are diagnosed in Denmark. The stage of the disease~     is an important prognostic factor as an advanced stage reduces the opportunity for surgical~     intervention and other curative treatment. In denmark, as in many other countries, a fast~     track evaluation for lung cancer has been introduced in 2008.~      When the general practitioners refer patients through the fast track, the majority of~     patients make their first visit to the Department of Pulmonary Medicine. After this visit,~     further investigation is initiated, which is often a CT scan of the chest and the upper~     abdomen. We dont know Whether this is the most appropriate organisation.~      The aim of this project is to evaluate the way lung cancer patients are examined through the~     fast track and the impact of chest CT before an evaluation by a chest physician.~      Investigators want to randomise all patients referred for the existing fast track to either~     direct CT scan of chest and upper abdomen or to evaluation by the chest physician, in order~     to test:~      A) Fast track performance measured by number of CT scans and chest physician specialist time~     per diagnosis, and whether there is a difference between the intervention and the control~     group.~   "
136564|NCT01779713|"~     Rational: The main danger with intracranial aneurism is its rupture conjugated with~     subarachnoid hemorrhage (SAH) occurrence. SAH is a severe pathology leading not only to~     neurological but also extra cerebral disorders. The major cause of morbidity and mortality~     when developing a SAH is the secondary development of a delayed cerebral ischemia consecutive~     to a prolonged vasospasm of cerebral arteries. The understanding of the pathophysiological~     mechanisms of SAH complication, such as vasospasm which is the more frequent, is essential.~      Vasospasm is defined as a reversible shrinking of an artery lumen diameter in the~     subarachnoid space, beginning generally between 4 and 12 days after the hemorrhage. Such a~     vasospasm could have a huge clinical impact leading to delayed neurological ischemic~     deficiency in 17 to 40 % of cases. Up to day, mechanisms involved in vasospasm occurrence are~     not well described.~      Disposing of well-established genetics and transcriptomics databases along with cerebral~     ischemia and inflammation is essential to unravel the mechanisms leading to vasospasm~     occurrence on SAH patients. It will enable researchers to better comprehend SAH pathology and~     elaborate an efficient and individualized therapeutic strategy to SAH acute phase in order to~     reduce the risk of vasospasm occurrence.~      Aims: 1) Constitute DNA and RNA Biobank via blood proofing oh SAH patients 2) Constitute a~     database grouping clinical and biological data 3) Look for genetic and transcriptomic early~     markers via genomic approaches 4) Correlate these different markers with vasospasm occurrence~     and clinical evolution of the patients~      Study: Patients inclusion will be done following their admission (D1) in the  unité de~     réanimation neurochirurgicale of Pitié-Salpètrière Hospital. After obtaining of the informed~     consent, blood proofing will be realized daily during 12 days: one daily 2.5ml tube for the~     transcriptomic study and a single 10ml EDTA tube for genetic analyses. Clinical and~     biological follow-up will be performed as usual.~      200 patients will be initially included during 2 to 3 years for the transcriptomic study of~     which 1/3 will develop vasospastic complication. The transcriptomic study will thus be~     performed by comparing patients developing or not developing this complication~      Expected Results: Unravel vasospasm early genetic markers.~   "
136565|NCT01779700|"~     This will be a single site safety and proof of concept study conducted at the Indiana~     University Psychotic Disorders Program. Forty subjects with schizophrenia or schizoaffective~     disorders will be randomized 1:1 to double-blind treatment with fingolimod or matched placebo~     for duration of 8 weeks.~   "
136573|NCT01779596|"~     The purpose of this study is to establish the effect of ET blockade on the acute exercise~     induced blood flow and endothelial function in subjects with T2DM. We hypothesize that~     combining ET - blockade with exercise training leads to an acute increase of exercise induced~     blood flow when compared with exercise alone. We expect that this will lead to an~     optimization of vascular training effect in T2DM.~   "
136574|NCT01779583|"~     Exosomes are formed by inward budding of late endosomes, producing multivesicular bodies~     (MVBs), and are released into the environment by fusion of the MVBs with the plasma membrane.~     It has been demonstrated that the content and function of exosomes depends on the originating~     cell and the conditions under which they are produced. Tumor exosome production, transfer and~     education of bone marrow cells supports tumor growth and metastasis.~      In this prospective translational study, preclinical and clinical phases have been designed.~     On the first step, the main goal is to characterize the molecular profile of gastric cancer~     derived exosomes. This exosome biosignature may provide a useful diagnostic tool. As a second~     step, the study will evaluate the prognostic and predictive value of gastric cancer exosomes~     levels in plasma and kinetics in a prospectively recruited cohort of advanced gastric cancer~     patients during first-line chemotherapy.~   "
136575|NCT01779570|"~     Influenza lower respiratory tract infection (LRTI) is a major cause of morbidity and~     mortality worldwide. While viral replication can be suppressed by antiviral treatment,~     excessive inflammatory responses, which are increasingly recognized to contribute to severe~     influenza complications, remain unopposed. Macrolides have been used widely to treat~     community-acquired pneumonia, and shown to exert anti-inflammatory effects in other~     respiratory diseases, providing clinical benefits. In this randomized, open-label,~     multicenter study, we aim to investigate the anti-inflammatory effects of macrolide treatment~     in influenza LRTI. Its impacts on the cytokine response, viral clearance, symptoms and~     disease resolution will be studied. Such results may lead to the development of new~     therapeutic approaches against severe influenza infection, and provide better insights into~     disease pathogenesis.~   "
136576|NCT01779557|"~     This study is to evaluate the effectiveness and safety of Huaren Peritoneal Dialysate and~     Baxter Peritoneal Dialysate, investigate the proper dialysis dose for Chinese CAPD patients.~   "
136577|NCT01779544|"~     Rehabilitation after lumbar disc surgery (prolapse) focuses on various elements such as~     endurance, strength, stretching and information. Evidence concludes that it is not harmful to~     return to activity after lumbar disc surgery, and restrictions to activities after these~     operations are today more or less nonexistent. Some studies have shown that high intensity~     programs might be more effective, but they are probably more expensive. In recent years~     cognitive interventions have received more attention in rehabilitation programs after lumbar~     disc surgery. The cognitive approach is focused on providing patient knowledge to reduce~     uncertainty so that he or she can understand what is important after lumbar disc surgery so~     that belief in self-efficacy increases. A goal of the rehabilitation is to get the patient to~     resume normal activities. Reviews ask for how much treatment are needed in a rehabilitation~     program after lumbar disc surgery.~      The study will be a randomized clinical trial. The study will compare two different~     post-operative rehabilitation programs (general information or general information + exercise~     therapy). Both groups will begin treatment 1 day after surgery. Subjects in exercise therapy~     group are supposed to continue with exercises 3 months.~      In this study the following hypothesis will be studied:~        1. Brief intervention, an educational model, alone after lumbar disc surgery do have the~          same effect on pain in legs and low back as brief intervention, an educational model,~          combined with exercise therapy.~        2. Exercises which are instructed after lumbar disc surgery in a rehabilitation program,~          are being done by the patients.~   "
136578|NCT01779531|"~     Human epidermalgrowth factor receptor-2(HER2) negative Luminal B subtype breast cancer~     patients are included. After 4 cycles of Capecitabine combined with Docetaxel(XT) protocol~     neoadjuvant chemotherapy ,those who reach partial response(PR) but not pathological complete~     response(pCR) are randomly divided into the group treated with XT protocol and the group with~     Capecitabine combined with Epirubicin and Cyclophosphamide(XEC) protocol ,then compare the~     disease free survival(DFS) and overall survival(OS) of two subgroup.~   "
136579|NCT01779518|"~     This is a single arm, open-label study which will be opened at specific clinical sites at the~     request of an investigator for the treatment of individual subjects for whom there are no~     other treatment options. Subjects will be treated for 24 weeks with sofosbuvir (400mg QD)~     with RBV; pegylated interferon may be added at the discretion of the investigator.~   "
136580|NCT01779505|"~     This trial will be test the safety, tolerability, and immunogenicity of GS-4774 (GI-13020) in~     various doses and dosing regimens in healthy adults at one center in the US. Subjects will be~     enrolled into 3 arms using a dose escalation scheme and randomized into one of two dosing~     regimen cohorts. There will be 10 subjects per arm/cohort (total of 60 subjects to achieve 48~     evaluable subjects enrolled), with study completion in 9-12 months.~   "
136581|NCT01779492|"~     The purpose of this clinical trial is to compare the pharmacokinetic characteristics of~     GL2907 XL 20mg tablet and Oxycontin CR 10mg tablet.~   "
136582|NCT01779479|"~     Cabazitaxel is a new taxoid which promotes the tubulin assembly in vitro and stabilizes~     microtubules against cold-induced depolymerization as efficiently as docetaxel and was~     selected for development based on a better antiproliferative activity on resistant cell lines~     than docetaxel. It has shown superior survival against mitoxantrone (MTX) plus prednisone in~     docetaxel pre-treated hormone refractory metastatic prostate cancer patients leading to~     registration of the compound. It showed a favorable toxicity profile with an interestingly~     low rate of alopecia. In the Genevieve study it will be compared against weekly paclitaxel~     which is currently most widely used treatment of breast cancer patients. A head-to-head~     comparison in the neoadjuvant setting will allow a rapid and precise comparison of efficacy~     and tolerability of cabacitaxel versus paclitaxel to decide in how far further development of~     this taxoid in breast cancer is reasonable.~   "
136583|NCT01779466|"~     This trial will investigate the relationship of sleep, daytime performance and nocturia in~     patients treated with Desmopressin or placebo. Male and Female patients will be administered~     Desmopressin or Placebo every day for 3 months.~   "
136584|NCT01779453|"~     This study will assess the safety, atorvastatin pharmacokinetics, and LDL-C lowering efficacy~     of ETC-1002 versus placebo in hypercholesterolemic subjects on background therapy of~     atorvastatin 10 mg.~   "
136585|NCT01779440|"~     Up to 77% of young people with severe mental illnesses smoke, a rate that is up to five times~     higher than the rate of daily smoking in other young adults. Contrary to popular belief,~     smoking tobacco does not provide any benefit for mental illness symptom control. People with~     severe mental illnesses (SMI: schizophrenia and severe mood disorders) are dying, on average,~     25 years earlier than those without SMI. Much of this early mortality is due to higher rates~     of heart and lung diseases, cancers, strokes, and diabetes.~      Cessation of smoking in these transition-age young adults can prevent cancer and increase~     life expectancy to that of non-smokers. Combination treatments are effective in this group~     and therefore key to improving outcomes, but few SMI smokers use them despite their interest~     in quitting. Motivational interventions for cessation increase interest in quitting, but~     public mental health clinicians do not deliver them, in part due to economic reasons. Thus~     cost effective methods to deliver motivational interventions to engage young smokers with SMI~     into treatment are needed.~      To address this gap, we have developed an electronic decision support system (EDSS) for~     smoking cessation that is specifically tailored for smokers with SMI, who tend to have~     cognitive deficits and limited computer experience. Similar to EDSSs developed for other~     health problems, this EDSS provides information and motivational exercises within an~     easy-to-use, web-based computer program that can be used with minimal or no staff assistance.~     Initial piloting of the EDSS in middle-aged SMI smokers showed excellent usability and~     promising efficacy. Pilot-testing among young patients suggested that the EDSS increased~     motivation to quit smoking and provided direction to adapt the format and content of the EDSS~     for young SMI smokers.~      The purpose of this proposal is to further develop the motivational decision support system~     and to test its ability to motivate young smokers with SMI to quit smoking with cessation~     treatment.~   "
136586|NCT01779427|"~     This is a research study to learn if a computer-based intervention that provides direct~     attention and metacognitive strategy development can improve attention, memory, and executive~     control in adolescents with moderate-to-severe TBI who are experiencing attention~     difficulties post injury.~   "
136587|NCT01779414|"~     This study looks to implement a novel intervention (STAT-ED) for children who screen positive~     to suicide ideation. The intervention looks to collect data from several different measures~     and then randomize participants into one of two groups: a control group where the participant~     will be set up with a mental health referral from a psychiatric social worker; or if~     randomized into the STAT-ED intervention, the adolescent and parent will receive a brief~     motivational interview, barrier reduction discussion, referral and limited case management by~     the study social worker to enhance outpatient mental health follow up after discharge from~     the ED.~      The hypothesis of the study is patients who are randomized into the STAT-ED intervention~     group will have a significantly higher rate of initiating mental health treatment and will~     attend more mental health treatment sessions in the two months after the ED visit compared~     with adolescents in the control group. Secondary aims of this study look to determine whether~     the effectiveness of the STAT-ED intervention differs by age, gender, or ethnicity; and~     evaluate predictors and mediators of mental health treatment engagement.~   "
136588|NCT01779401|"~     To identify the high-risk patients who might have in-stent thrombosis after PCI with~     thromboelastography and to head-to-head compare two intensified antiplatelet therapeutic~     strategies of double-dosage Clopidogrel and triple antiplatelet therapy with Cilostazol with~     the standard antiplatelet therapy.~   "
136589|NCT01779388|"~     Due to CT screening, a lot of peripheral nodule not accessible to conventional endoscopy will~     be found. Electromagnetic navigation directed bronchoscopy (ENB) is a new technique needing~     validation. the primary aim of the study is to compare ENB to radiologically guided~     bronchoscopy, considered the standard comparator.~   "
136590|NCT01779375|"~     The RISE Pediatric Medication Study is a 2-arm, 4-center, clinical trial of children with~     prediabetes and early type 2 diabetes to address the hypothesis that aggressive glucose~     lowering will lead to recovery of beta-cell function that will be sustained after withdrawal~     of treatment. Pediatric participants (ages 10-19) will be randomized to one of the following~     treatment regimens: (1) metformin alone or (2) early intensive treatment with basal insulin~     glargine followed by metformin.~      The primary clinical question RISE will address is: Are improvements in ß-cell function~     following 12 months of active treatment maintained for 3 months following the withdrawal of~     therapy? Secondary outcomes will assess durability of glucose tolerance following withdrawal~     of therapy, and whether biomarkers obtained in the fasting state predict parameters of ß-cell~     function, insulin sensitivity and glucose tolerance and the response to an intervention.~   "
136591|NCT01779362|"~     The RISE Adult Medication Study is a 4-arm, 3-center, clinical trial of adults with~     prediabetes and early type 2 diabetes to address the hypothesis that aggressive glucose~     lowering will lead to recovery of beta-cell function that will be sustained after withdrawal~     of treatment. Adult participants (ages 20-65) will be randomized to one of the following~     treatment regimens: (1) blinded placebo, (2) blinded metformin alone, (3) early intensive~     insulin treatment with basal insulin glargine followed by open-label metformin, (4) the~     glucagon-like peptide-1 receptor agonist (GLP-1RA) liraglutide plus open-label metformin.~      The primary clinical question RISE will address is: Are improvements in ß-cell function~     following 12 months of active treatment maintained for 3 months following the withdrawal of~     therapy? Secondary outcomes will assess durability of glucose tolerance following withdrawal~     of therapy, and whether biomarkers obtained in the fasting state predict parameters of ß-cell~     function, insulin sensitivity and glucose tolerance and the response to an intervention.~   "
136592|NCT01779349|"~     Current gold standard of bladder outlet diagnosis is pressure flow study. This study is~     invasive time consuming and requires expensive and complex set-up. In this study the~     investigators plan to evaluate an alternative technology that presumably is able to diagnose~     bladder outlet obstruction using a Dynamic Urine Vibration Holter based on a Urine Flow~     Vibration Analysis technology. The acoustic vibration sensor is a small device that records~     the vibration due to urine flow. The patient attaches the sensor to the penis using a~     disposable sensor patch for the duration of approximately one minute during one urination.~     The analysis is performed off-line and the results are compared to the results of a standard~     pressure flow study and to the standard free flowmetry test. The innovative technology for~     the diagnosis of bladder outlet obstruction is noninvasive, rapid and does not involve~     complex setup.~   "
136593|NCT01779336|"~     Clinical study of oral IGF-1R inhibitor PL225B in subjects with advanced refractory solid~     tumors. The primary objective is to determine the maximum tolerated dose and dose limiting~     toxicity (ies) of oral IGF-1R inhibitor PL225B in subjects with advanced refractory solid~     tumors.~   "
136594|NCT01779323|"~     The hypothesis is men with stress urinary incontinence, including those following radical~     retropubic prostatectomy and other prostate surgery, have preoperative urethral mobility as~     measured by magnetic resonance imaging (MRI) that improves significantly following sling~     placement. The investigators theorize that the sling helps with primary hypermobility of this~     pathophysiologic cause of stress urinary incontinence.~   "
136595|NCT01779310|"~     There are guidelines on the management of AD in China, the evidence adopted in the guidelines~     are mostly from the trials conducted in other countries due to very limited Chinese data~     available for local systematic review. Therefore, more local evidence on dementia care is~     needed for the development of an evidence-based guideline appropriate for people living in~     China. Meanwhile, the inadequate implementation of the current AD guideline, which results in~     the low diagnostic rate and high diagnostic leakage, may bring about extra barriers for AD~     patients to access dementia care service in different areas nationwide. However, there is no~     data on the clinical pathway about how physicians follow the dementia guideline in the~     routine practice.~      Therefore, research is needed to learn clinical diagnostic process and treatment patterns of~     physicians to people with AD in routine practice and help address the low accurate rate of AD~     clinical diagnosis and low anti-dementia drug prescription in the real world and support~     guideline development.~   "
136596|NCT01779297|"~     The purpose of this study is to determine whether introducing the new weaning indexes can~     predict better than traditional ones?~   "
136597|NCT01779284|"~     The primary objective of this crossover trial is to compare the 3-month, mean 24-hour~     intraocular pressure (IOP) control and safety obtained with two popular fixed combinations in~     glaucoma patients insufficiently controlled with latanoprost monotherapy. This study will~     compare the 24-hour efficacy of travoprost/timolol fixed combination without benzalkonium~     chloride given once in the evening, versus the latanoprost/timolol fixed combination given in~     the evening. It is assumed that travoprost/timolol fixed combination will provide better~     quality of 24-hour pressure control.~   "
136598|NCT01779271|"~     Multi-center, Randomized, Double blind, Controlled Parallel-group Comparative Phase 3~     Clinical trial to assess the efficacy and safety of Pelubiprofen Compared to Loxoprofen in~     patients with Acute upper respiratory infection.~   "
136599|NCT01779258|"~     The purpose of this study is to confirm that emollients play a major role in the maintenance~     therapy after clearing of inflammatory lesions and can reduce occurrence of flares in~     children with atopic dermatitis.~   "
136600|NCT01779245|"~     A high-calcium intake can accelerate fat loss under energy-restricted diets. Part of this may~     be due to a shift in substrate metabolism where there is an increase in the rate of fat~     oxidation. However, whether high-calcium intake can influence substrate metabolism during~     exercise is not known. Accordingly, we aim to investigate the effect of 2 weeks of~     high-calcium intake on substrate metabolism during exercise.~   "
136601|NCT01779232|"~     The purpose of this study is to determine whether pre-treatment with danazol for at least 4~     months before controlled ovarian hyperstimulation for IVF cycles improves pregnancy rate.~   "
136602|NCT01779219|"~     Background: The aim of the study was to assess the safety and effectiveness of stereotactic~     brain tumour biopsy (STx biopsy) guided by low-field intraoperative MRI (iMRI) in comparison~     with its frameless classic analogue based on a prospective randomized trial.~      Patients are prospectively randomized into a low-field iMRI group and a control group that~     undergo a frameless STx biopsy. The primary endpoints of the analysis are: postoperative~     complication rate and diagnostic yield, and the secondary endpoints: length of hospital stay~     and duration of operation.~   "
136603|NCT01779206|"~     Trial for the optimization of risk assessment and therapy success prediction in patients with~     early breast cancer by the use of biomarkers in advance to therapy decision-making to~     personalize therapies.~   "
136604|NCT01779193|"~     B streptococcal infection and the major cause of death before and after the baby is born. B~     streptococcus infection the way of the newborn, usually infection from the mother in~     childbirth, if the pregnant women during pregnancy early diagnosis B streptococcus infection,~     it can be effective in preventing the risk of neonatal infection. Department of Health in~     China has been since April 15, 2012, the Scholarship holder at all pregnant women in the~     35-37 weeks of pregnancy comprehensive B streptococcus screening. Infection B Streptococcus~     pregnant women in the labor process, the use of prophylactic antibiotics can be effective in~     reducing neonatal B streptococcus infection, but the possibility of the fetus being infected~     for the condition of premature birth or early rupture of membranes are still unable to fully~     hedge. In this study, the 35 to 37 weeks gestation examination confirmed infected B~     Streptococcus pregnant women, oral lactobacillus capsules B streptococcus infection treatment~     efficacy and safety assessment of clinical research. To assess whether oral administration of~     lactic acid bacteria will affect vaginitis incidence.~   "
136605|NCT01779180|"~     INTRODUCTION Eight trials studying the effect of providing neonatal vitamin A supplementation~     (NVAS) have been reported, and another four are underway to test whether NVAS should become~     WHO policy. Three of the four African trials were conducted by the Bandim Health Project~     (BHP) in Guinea-Bissau. One of them was a two-by-two factorial trial among low-birth-weight~     children. From 2004-2008, the children were randomly allocated to 25,000 IU vitamin A or~     placebo at birth, and furthermore to BCG vaccination at birth or later as is local policy. In~     2011, the investigators conducted a follow-up study. A remarkably strong harmful effect of~     NVAS on atopy and wheezing was found (manuscript under review).~      Seen in the context that NVAS may soon become a WHO policy it is obviously worrying if NVAS~     is associated with a higher risk of atopy and wheezing. The investigators therefore aim to~     conduct a similar follow-up study of participants in the first NVAS trial conducted in~     Guinea-Bissau from 2002-2004, among normal-birth-weight infants, to test whether NVAS is~     associated with an increased risk of atopy and wheezing and other allergic symptoms as well~     as growth.~      METHODS~      Study population:~      From 2002-2004 BHP conducted a randomised trial of NVAS. The investigators recruited newborns~     when they came for BCG vaccination. Provided parental consent, they received an oral~     supplement of 50,000 IU vitamin A or placebo.~      Study design:~      This study will be a follow-up study of the cohort of children randomised to NVAS~     (intervention) or placebo (current policy) together with BCG vaccine at birth.~      Other exposures:~      The investigators will also investigate the effect of receiving an additional dose of measles~     vaccine and the timing of DTP vaccine on the development of atopy.~      Assessment of outcomes:~      The investigators will visit all children at the last known address. Height, weight and mid~     upper arm circumference will be measured. BCG scar will be examined and vaccination card~     details recorded by the field assistant. Children will be excluded from skin prick testing~     (SPT) if they have a history suggestive of anaphylaxis or are currently using anti-histamine~     medication. SPT will be performed using aero-allergens, food allergens and positive histamine~     and negative saline control. The mother or guardian will be interviewed by a local assistant.~     Symptoms of eczema and asthma as well as food allergy will be assessed.~      Statistical analysis:~      Effect of randomisation group and other factors on outcomes will be analysed in multivariable~     regression models. All analyses will be adjusted for skin prick tester. All analyses will be~     conducted stratified by sex.~   "
136606|NCT01779167|"~     The purpose of this study is to evaluate the efficacy and safety of daily alternating~     thalidomide and lenalidomide plus rituximab (ThRiL) in patients with previously treated~     Waldenstrom macroglobulunemia (WM). Thalidomide and lenalidomide are drugs that modulate the~     immune system and have been shown to bring about responses in subjects with WM. However,~     their use has been limited due to side effects. The investigators hypothesize that~     alternating doses of thalidomide and lenalidomide may alleviate the side effects while~     preserving the effectiveness of the therapies.~   "
136607|NCT01779154|"~     The Eosinophilic Gastrointestinal Disorders (EGIDS) Registry is a longitudinal study that~     does not involve medical interventions, but serves as a record of demographics,~     characteristics of disease and treatment, utilization patterns, quality improvement measures~     and clinical outcomes. The database is proposed so that epidemiologic research can be~     performed and current and accurate data can be obtained regarding practice patterns, age and~     gender distributions, efficacy of treatment, clinical outcomes and changes in quality of~     life.~   "
136608|NCT01779141|"~     The aim of this project is to document the use of insulin pump therapy (CSII), including~     sensor augmented pump therapy (SAP), before, during and after pregnancy in women with type 1~     Diabetes Mellitus benefiting from the Orchestra donation of Paradigm REAL-Time and Paradigm~     Veo pumps in Poland.~   "
136609|NCT01779128|"~     This research study is an imaging pilot study. Imaging pilot studies explore the potential~     benefit of one imaging approach compared to another clinically accepted approach. Such~     studies serve to understand how feasible an approach may be and whether it is worth pursuing~     in formal and larger clinical trials. Researchers of this study believe that simultaneous~     Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET) imaging will offer~     additional imaging information to improve cancer detection.~      MRI and PET are two tests that allow us to take pictures of the body and look inside the~     body without surgery. The MRI scanner uses a powerful magnet to make a picture of the body.~     The PET scanner makes pictures by using special dyes that light up inside the body. PET~     scans use radiation, similar to the radiation in a standard x-ray. We routinely use both~     tests to diagnose various types of cancer. As of now, the combination of PET and computed~     tomography (CT) has been considered a standard of care imaging approach for various cancers.~      Until recently, MRI and PET tests were done separately. Now there is a new type of test~     called MR-PET that combines both MRI and PET test results. This scanner uses both MRI and PET~     tests at the same time. We would like to find out if the MR-PET scanner can produce better~     and clearer images (pictures) of tumors and information about them inside of the body.~      This new MR-PET scanner is approved by the US FDA. However, some of the computer programs~     that tell the machine how to acquire and combine the test results are new and experimental.~     Experimental means that some of the computer programs are not approved by the FDA. This means~     that they can only be used in research studies. The MR-PET scanner has been previously used~     in a few human participants.~   "
136610|NCT01779115|"~     A computerized registry of diabetes patients in a large health maintenance organization in~     Israel. The registry is aimed to be used by health professionals to identify diabetes~     patients and to follow the courses of their illnesses and risk factors.~   "
136611|NCT01779102|"~     A new, more specific skin test to detect tuberculosis has been developed by Statens Serum~     Institut in Denmark. The new skin test is named C-Tb and like the current Tuberculin a~     positive test result will show as redness and/or induration at the injection site, while a~     negative test will leave no reactions.~      The aim of this study is to address if the size of induration and the sensitivity of C-Tb is~     influenced by concomitant injections of C-Tb and Tuberculin. Furthermore, the intention is to~     evaluate the safety of C-Tb when injected alone or concomitantly with Tuberculin.~   "
136612|NCT01779089|"~     Diabetic kidney disease increases the risk of illness and death from heart disease in~     patients with Type 2 diabetes. Some blood pressure medications called ACE inhibitors and ARBs~     slow progression of kidney disease, but the dose that can be used is often limited by side~     effects that are experienced by patients. The most limiting side effects of the current~     treatments are lowering of the kidney function or blood pressure, and a rise in blood~     potassium levels. A safe and inexpensive medication that doesn't lower kidney function or~     blood pressure or raise serum potassium would be useful.~      Minocycline is a tetracycline antibiotic with recently appreciated protective properties. In~     a published journal article by Dr. Isermann, minocycline prevented the death of specialized~     kidney cells in mice. The kidneys of these mice did not develop diabetic kidney disease when~     seen under the microscope and the mice experienced only a little bit of protein loss in the~     urine. In a different published paper, the authors showed that minocycline also decreased~     kidney injury in a model of non-diabetic kidney disease. A related tetracycline antibiotic~     was shown to lower urine protein in diabetic patients. These data support a rationale for~     testing to see if minocycline is safe and helpful in patients with diabetic kidney disease.~     In this study, all patients will stay on their usual medications for the treatment of~     diabetic kidney disease. Patients will be given either minocycline (100 mg by mouth twice a~     day for 24 weeks) or placebo (an inactive capsule taken twice a day for 24 weeks).~     Minocycline or placebo will be assigned by a process called randomization, which is like a~     coin toss. Neither the patient nor the study team will know if the patient is taking placebo~     or minocycline until the end of the study. The study will assess minocycline safety and test~     to see if minocycline is helpful or not helpful for the treatment of diabetic kidney disease.~      This study was funded by the American Diabetes Association and is not supported by any~     pharmaceutical company.~   "
136613|NCT01779076|"~     Using a protective ventilation strategy during general anesthesia from pre-oxygenation to~     emergence and selecting patients without risk of a difficult airway or intubation, a lower~     fraction of inspiratory oxygen (FIO2) can be used during extubation. This might reduce the~     postoperative area of atelectasis without desaturations becoming more common.~   "
136614|NCT01779063|"~     Lymphedema is a chronic condition that causes physical and emotional challenges to breast~     cancer survivors. As a progressive condition, lymphedema can result in swelling/fibrosis that~     can impair function, promote infection, and cause discomfort and emotional distress. Daily~     self-care that is required to manage lymphedema is time-consuming, burdensome, and lifelong.~     Previous studies found that about half of breast cancer survivors with lymphedema do not~     complete self-care as directed. Feelings of being helpless to manage the condition, a desire~     to be normal, lack of noticeable results from self-care, and poor social/healthcare~     professional support are barriers to performing self-care on a regular basis. There is a need~     to develop and test interventions to promote effective self-care. Experts suggest the best~     self-care interventions should include patient perspectives and be available a readily~     accessible format. Technological advancements support use of innovative, creative approaches,~     such as Web-based multimedia interventions. Web-based interventions can be used in rural and~     urban settings. The investigators are proposing to develop a Web-based, multimedia~     intervention and a take home manual to support self-care in breast cancer survivors with~     lymphedema. The investigators plan to conduct focus groups with these survivors to determine~     the content and delivery format(s) and to help us identify breast cancer survivors with~     lymphedema for the video component. The investigators will then develop an intervention that~     will include self-care demonstrations and other supportive information to help patients to~     cope with the challenges of self-care. The focus groups will reconvene, review the~     intervention, and give us feedback on modifying and refining the intervention. After~     finalizing the intervention, The investigators will recruit more breast cancer survivors with~     lymphedema and provide one half of them an education booklet and the other half the Web-based~     intervention (or an alternative format such as DVD). Then, over 12 months, the investigators~     will periodically assess and compare both groups on self-care behaviors, physical and~     emotional concerns, and other issues such as money spent on lymphedema treatment. The group~     that receives the education booklet will be given access to the Web-based intervention after~     the 12 month follow-up is done, but the investigators will not ask them to complete any more~     forms.~      This project builds upon the investigators prior work that has provided information about~     lymphedema self-care problems and the investigators previous experience in developing patient~     education videos and manuals. By providing accessible, detailed self-care instructions and a~     psychosocial component, this intervention has the potential to improve lymphedema self-care.~     If successful, this intervention can be offered to the larger national and international~     community of breast cancer survivors with lymphedema.~   "
136615|NCT01779050|"~     This phase II trial studies the efficacy of trastuzumab treatment in breast cancer patients~     with stage II-III human epidermal growth factor receptor 2 (HER2)-negative tumors and~     HER2-expressing bone marrow disseminated tumor cells. Administering targeted trastuzumab~     therapy to these patients may result in the elimination of HER2 expressing disseminated tumor~     cells and improved disease free survival.~   "
136617|NCT01779024|"~     Background:~      - Ghrelin is a hormone in the human body that is mostly produced by the stomach. It makes~     people feel hungry, and also is connected with the desire to drink alcohol. Researchers want~     to test ghrelin to see if it can be used to control alcohol cravings and use. They will~     compare doses of ghrelin with a placebo in people who drink heavily.~      Objectives:~      - To study the effects of ghrelin on alcohol craving and use.~      Eligibility:~        -  Individuals between 21 and 60 years of age who are heavy drinkers but are not seeking~          treatment for alcohol use.~        -  Participants must on average have more than 20 drinks per week for men, and more than 15~          drinks per week for women.~      Design:~        -  Participants will have a screening visit, four 2-night study visits, and a follow-up~          visit.~        -  Participants will be screened with a physical exam and medical history. They will~          provide urine and breath samples for drug testing. They will also answer questions about~          mood and physical symptoms, and about alcohol and other cravings.~        -  At the study visits, participants will stay overnight at the National Institutes of~          Health clinical center. They will spend the night at the center, have tests on the next~          day, and go home on the following morning. At each visit, participants will receive a~          ghrelin or placebo infusion, and will complete a series of tasks.~        -  For the first and second study visits, participants will have tests of alcohol craving~          and use. They will be able to receive alcohol infusions through a computer program that~          tests response time and craving reactions. At the same time, they will have a ghrelin or~          a placebo infusion. Blood alcohol levels, reaction time, and craving will be studied.~        -  For the third and fourth study visits, participants will have a magnetic resonance~          imaging (MRI) study. They will have an initial MRI to provide a picture of the brain.~          They will then have a functional MRI during which they will respond to a computer test.~          The test will allow them to win points for snack food or alcohol. This test will look at~          the brain s response time and craving reactions.~        -  There will be a follow-up visit 1 week after the fourth study visit. Some of the tests~          from the screening visit will be repeated.~   "
136618|NCT01779011|"~     The prospective cohort study, SuTra2, assesses the functional and socio-economic status of~     patients who were operated on for a severe limb injury resulting in amputation or limb~     preservation 1 and 2 years after the 2010 Haiti earthquake.~   "
136619|NCT01778998|"~     One of the most recent advances in cataract surgery is microincisional phacoemulsification~     (MICS). Through small incisions of 2.0 mm and less the lens material is emulsified either~     bimanually or with a thin single coaxial hand-piece. The possible advantages are lower~     induced corneal astigmatism1, 2, possibly a lower incidence of infection due to higher~     resistance of the wound to deformation3 and a lower risk of complications such as iris~     prolapse during surgery in patients at risk such as with intraoperative floppy iris syndrome~     (IFIS). Additional factors that have to be taken into account are the construction and the~     position of the incision and the influence of the extraocular force on the wound morphology.4~     Another effect that may influence the wound architecture is stromal hydration at the end of~     surgery.5 Wound architecture has recently been assessed6-9 using optical coherence~     tomography. Elkady et al.10 observed the wound architecture in MICS cases focusing on corneal~     thickness and the incision angle. However, none of these studies observed the effect of the~     wound architecture on post-operative astigmatism. Furthermore, all observations in the past~     have been performed in the post-operative period only and information concerning the wound~     architecture intra-operatively is missing. A recently launched CE-marked intra-operative OCT~     allows observing the wound architecture intra-operatively.~      One aim of the study is to assess the influence of the intra-operative wound architecture~     using a similar grading system as used by Calladine and Packard (2007)7 on the resistance to~     deformation of the wound and the surgically induced astigmatism in MICS and small incision~     cataract surgery (SICS). In a second part of this exploratory study the effect of a hinged~     incision with a pre-cut should be assessed along the same line~   "
136620|NCT01778985|"~     This is a study to determine how vaginal estrogen cream given for several weeks before pelvic~     reconstructive therapy will effect elastic fiber assembly in the muscularis layer of the~     vaginal wall. Postmenopausal women with at least Stage 2 pelvic organ prolapse will receive~     either estrogen vaginal cream or placebo cream 6-8 weeks prior to reconstructive surgery. At~     time of surgery, full thickness biopsies will be obtained from a standardized location at the~     top of vagina. The investigators will measure the thickness of the vaginal muscularis,~     elastic fiber number and morphology, and analyze if elastic fiber synthesis or degradation is~     affected by estrogen therapy. The results will provide important data to support a larger~     clinical trial to determine if preoperative and maintenance estrogen therapy alter long-term~     success rates of pelvic reconstructive surgery for pelvic organ prolapse.~   "
136621|NCT01778972|"~     Fall-related injuries are a major health problem in the growing older population. Most older~     people are not aware of that physical training can decrease the risk of falling. The aim of~     tha study is to investigate the effect of the Otago home exercise programme with and without~     motivational interviewing in community-dwelling people 75 years or older on frequence of~     falls, fall-related injuries, physical capacity, fall-related self-efficacy, quality of life,~     mortality and health-related costs.~   "
136622|NCT01778959|"~     Cataract surgery is one of the most frequently performed surgeries worldwide and~     complications are rare. However, there are factors that increase the risk of complications,~     such as poor pupil dilation and intra-operative floppy iris syndrome (IFIS). Reasons for a~     small pupil size are pseudoexfoliation syndrome (PXF) syndrome, uveitis or synechia and the~     use of pilocarpin drops. IFIS is a syndrome usually caused by systemic alpha1-blockers~     (foremost tamsulosin) used to treat benign prostatic hyperplasia.1,2 As described by Chang~     and Campbell3 IFIS is characterized by billowing of a flaccid iris stroma, a propensity for~     iris prolapse towards the phacoemulsification tip as well as towards the incisions and~     progressive intra-operative pupil constriction.~      Stopping tamsulosin pre-operatively did not show to effectively prevent IFIS.4,5 However, it~     is of high importance to identify patients prior to surgery, who are treated with~     alpha1-blockers, or patients with a small pupil size and poor pharmacological pupil dilation.~     Some methods, such as intracameral injection of phenylephrine is only sufficient in a few~     cases 6, and a disadvantage is the risk of a hypertensive episode.7 Another pharmacological~     method is the use of atropine drops pre-operatively, but this method did not show to~     sufficiently reduce IFIS.4~      Different methods were shown to reduce intra-operative problems due to IFIS/small pupil size:~      The use of highly cohesive ophthalmic viscosurgical devices (OVD), also called~     viscoadaptives, such as sodium hyaluronate (e.g. AMO Healon5 or Croma Eyefill H.D.) help to~     viscodilate the pupil and by resting on the iris during the entire phacoemulsification~     procedure reduce the risk of iris prolapsing towards the incisions. This method is more~     dependent on a central phacoemulsification technique and low fluidic parameters to allow the~     OVD to stay on the iris during the entire procedure.8 In case of a small pupil, pupil~     stretching with 2 instruments can be used additively.~      Another option to stabilize the pupil size is the use of mechanical pupil expansion devices,~     such as~        1. Iris retractors - these devices are routinely used to dilate the pupil~          intra-operatively. Typically, 4 or 5 iris retractors, also called iris hooks, are~          inserted through 4-5 incisions. Usually, the IFIS pupil is very elastic and the risk of~          overstretching is small.8~        2. Pupil expansion rings, such as the Malyugin ring. This ring is placed on the pupil~          margin with an injector through the main incision. It eliminates the need of additional~          incisions and saves time.9~      Rationale To compare different methods to manage IFIS and poor pupil dilation in cataract~     surgery: a pupil expansion ring (Malyugin Ring), iris retractors (iris hooks) and a~     viscoadaptive OVD.~   "
136628|NCT01778881|"~     Bruxism is a parafunctional habit characterized by grinding and/or clenching of the teeth. It~     may happen while awake (awake bruxism) or while sleeping (sleep bruxism). In adults, the~     prevalence is 20% for the awake bruxism and 8% for the sleep bruxism. Peripheral, central,~     and psychosocial factors influence the disorder, which may predispose to pain in the~     masticatory muscles and neck, headache, decreased pain thresholds in the masticatory and~     cervical muscles, limitation mandibular opening, sleep disorders, stress, anxiety,~     depression, and overall impairment of oral health. The aim of this study is to compare~     physical therapy interventions with dental treatment in pain, mandibular opening, sleep~     quality, anxiety, stress, depression, and oral health in individuals with bruxism.~   "
136623|NCT01778946|"~     This study will ascertain whether nicotine is safe and tolerable in DS patients, help with~     dose-ranging of nicotine in DS, look for evidence of enhancements in cognitive functioning,~     and establish evidence for biological and behavioral correlates of nicotinic stimulation~     effects. The knowledge gained from the translational aspects of this project may also guide~     the application of new nicotinic drugs in DS and generate, for the first time, data on the~     importance of nicotinic receptor changes in the development of cognitive impairment in DS~     adults.~      Hypotheses:~        -  Transdermal nicotine treatment will be well tolerated out to one month by non-smoking DS~          patients without significant adverse effects.~        -  Nicotine will enhance cognitive performance by one month compared to baseline and~          post-treatment testing.~        -  Nicotine will enhance functioning detectable by clinician and/or informant ratings~          (pre-post).~   "
136624|NCT01778933|"~     According to the National Cancer Institute, an estimated 64,770 men and women will be~     diagnosed with kidney cancer in 2012. Of this number, an estimated 13,570 will die of this~     disease. Surgery remains one of the best options for patients presenting with operable Stage~     II or III cancers, however the five year survival rate for these candidates remains at a~     dismal 63.7% for Stage II and 11% for Stage III. The high rates of recurrence suggest that~     surgeons are unable to completely detect and remove primary tumor nodules in a satisfactory~     manner as well as lingering metastases in sentinel lymph nodes. By ensuring a negative margin~     through imaging during surgery it would be possible for the investigators to improve the~     rates of recurrence free patients and thus overall survival.~      Renal cell malignancies are the ideal disease to investigate intra-operative imaging. 70% of~     kidney malignancies express folate receptor alpha (FRA). It is important to note that FRA is~     expressed only in the proximal tubules of the kidneys, activated macrophages, and in the~     choroidal plexus. Thus, the false positive detection rate is expected to be extremely low. A~     group well known to us in the Netherlands has completed a pilot study utilizing a folate-FITC~     conjugate in 12 patients with ovarian cancer. Another group of investigators in Mayo have~     subsequently performed this study on 20 more patients without any serious adverse events~     (personal communication). They report excellent sensitivity and specificity with this~     technique with only grade 1 side effects (allergic reaction). All side effects reversed when~     the injection was halted. Patients with a history of allergic reactions to insect bites~     should not participate (fluorescein is derived from the firefly insect, folate is an~     essential vitamin).~   "
136625|NCT01778920|"~     The goal of this study is to perform imaging of patient's tumors while the chest is open and~     the tumor is being removed.~      According to the World Health Organization, lung cancer is the most common cause of~     cancer-related death in men and women, and is responsible for 1.3 million deaths worldwide~     annually as of 2004. Surgery remains the best option for patients presenting with operable~     Stage I or II cancers, however the five year survival rate for these candidates remains at a~     dismal 53% for Stage I and 32% for Stage II. The high rates of recurrence suggest that~     surgeons are unable to completely detect and remove primary tumor nodules in a satisfactory~     manner as well as lingering metastases in sentinel lymph nodes. By ensuring a negative margin~     through imaging during surgery it would be possible for us to improve the rates of recurrence~     free patients and thus overall survival.~      Thoracic malignancies are the ideal disease to investigate intra-operative imaging. Over 85%~     of lung and pleural malignancies express folate receptor alpha (FRA). It is important to note~     that FRA is expressed only in the proximal tubules of the kidneys, activated macrophages, and~     in the choroidal plexus. Thus, the false positive detection rate is expected to be extremely~     low. A group well known to us in the Netherlands has completed a pilot study utilizing a~     folate-fluorescein isothiocyanate (folate-FITC) conjugate in 12 patients with ovarian cancer.~     Another group of investigators in Mayo have subsequently performed this study on 20 more~     patients without any serious adverse events (personal communication). They report excellent~     sensitivity and specificity with this technique with only grade 1 side effects (allergic~     reaction). All side effects reversed when the injection was halted. Patients with a history~     of allergic reactions to insect bites should not participate (fluorescein is derived from the~     firefly insect, folate is an essential vitamin).~   "
136626|NCT01778907|"~     Depression is common among elderly with an estimated prevalence of 5%. Due to ageing the~     national burden will double in the coming decade. Antidepressants as TCAs and SSRIs are~     effective in reducing symptoms, especially in people with severe depression. To optimize~     treatment efficacy and reduce side effects, the Pharmacogenetics Working Group of the Royal~     Dutch Pharmacists Association developed guidelines for dose-adaptation, for instance for~     antidepressants such as nortriptyline and venlafaxine based on their main relevant genotype~     (CYP2D6) accompanied by Therapeutic Drug Monitoring. Such personalized drug dosing based on~     pharmacogenetic information at the start of therapy can speed up the titration phase of~     antidepressants to establish an adequate maintenance dose. However, pharmacogenetic screening~     programs are expensive and evidence on effects and costs of such a program among elderly~     antidepressant starters from randomized controlled studies is lacking. The investigators will~     conduct a pragmatic randomized controlled trial to determine the effects and costs of~     pharmacogenetic screening information to optimize drug dosing in depressed elderly patients~     who start with nortriptyline or venlafaxine.~      Objective: The primary objective is to determine the effects of pharmacogenetic screening for~     CYP2D6 on the time to reach adequate blood levels as an accepted proxy for adequate~     treatment. Secondary objectives include adverse drug reactions and cost-effectiveness~      Study design: pragmatic randomized controlled intervention study~   "
136627|NCT01778894|"~     According to the most recent information released by the American Heart Association, heart~     failure affects 5.8 million Americans and over 23 million people worldwide. In particular,~     diastolic heart failure (DHF) has emerged in approximately half of those suffering from heart~     disease and has become a major public health problem for many reasons, including the~     complexity of the disease, lack of effective drugs/therapies, requirement of invasive tests~     to diagnose and monitor DHF, and the absence of a suitable scientific model to study the~     disease. Scientists and physicians alike still do not fully understand what happens to the~     muscles in the heart (myocardium) patients who present with diastolic dysfunction or DHF.~     Therefore, the medical field is in need of an accurate model that can evaluate how diastolic~     dysfunction leads to heart failure and what happens at a cellular level as this disease~     emerges and progresses.~   "
136662|NCT01778439|"~     This is an open-label Phase 1a dose escalation study of single-agent OMP-52M51 in subjects~     with relapsed or refractory solid tumors. Study includes a dose escalation phase and~     expansion phase. Subjects will be assessed for safety, immunogenicity, pharmacokinetics,~     biomarkers, and efficacy.~   "
136663|NCT01778426|"~     Observational study to evaluate the long term efficacy of Spinal Cord Stimulation (SCS) over~     2 years following SCS implant.~      This study is requested by French Health Authorities for reimbursement renewal, to maintain~     reimbursement for SCS in approved indication in France.~   "
136629|NCT01778868|"~     Hormonal disruption is the inappropriate alteration of the hormonal system by chemical~     substances that are present in our environment. Some chemical substances are capable of~     replicating, enhancing or reducing the production, release, transport or action of natural~     hormones. Therefore, they are called hormonal or endocrine disrupters. Some 'classic'~     endocrine disrupters such as pesticides and dioxins are considered responsible for~     infertility, cancer and thyroid problems. Recently, a number of additional chemical~     substances were stipulated to have endocrine disrupting capabilities. The industrial~     production of these substances in large quantities has led to an accumulation in our~     environment and thus possible negative consequences on human health.~      The aim of this study is to investigate the rol of these chemical substances in the occurence~     of overweight and obesity.~   "
136630|NCT01778855|"~     The primary objective of this Phase 2 HASTIER study, as an ancillary study to ICTuS 2, is to~     compare key imaging measurements for serial changes in recanalization and reperfusion between~     hypothermia and normothermia treatment arms as intermediate outcomes of treatment effect.~     Secondary exploratory analyses include imaging of the neurovascular impact of reperfusion~     with hypothermia and tPA, including blood-brain barrier changes or permeability, hemorrhagic~     transformation, and infarct growth.~   "
136631|NCT01778842|"~     The elderly represent a growing segment of the coronary population treated by dual~     antiplatelet therapy for percutaneous coronary intervention (PCI). These patients bear a~     higher risk of both ischemic events and bleeding complications than younger patients, with a~     subsequently higher rate of mortality.Recentprogress in antithrombotic treatment demonstrated~     the efficacy of adding a P2Y12 receptor antagonist to low-dose aspirin. Whether this benefit~     is also present in the elderly remains a debated issue due to the lack of specific data in~     this sub-population. The present study was realized to provide specific data on platelet~     response to clopidogrel, standard dose (75 mg) or prasugrel 5 mg in elderly patients (≥75~     years old) whereas the superiority in PR response of the latter should allows the Prasugrel~     therapy in elderly patients with the better clinical efficacy and therapeutical safety~     already showed compared with Clopidogrel.~   "
136632|NCT01778829|"~     The purpose of this study is to determine whether Nasal intermittent positive pressure~     ventilation (NIPPV) non synchronized is better than continuous positive airway pressure~     (NCPAP)in preventing extubation failure within 72 h, after extubation of very low birth~     weight infants at the NEOCOSUR Network.~   "
136633|NCT01778816|"~     Multicenter Achilles tendon study Switzerland. Comparing three mainstream treatment types:~     open, percutaneous and conservative (non-operative) treatments.~      Comparing force torque measurements, muscle volume and clinical scores.~   "
136634|NCT01778803|"~     This is a Phase I/Ib, open-label, multicenter, dose-escalation trial of paclitaxel in~     combination with defactinib (VS-6063), a focal adhesion kinase inhibitor, in patients with~     advanced ovarian cancer. This clinical study is comprised of 2 parts: Phase I (Dose~     Escalation) and Phase Ib (Expansion). The purpose of this study is to assess assess the~     safety (including the recommended phase 2 dose), the pharmacokinetics, and the anti-cancer~     activity of defactinib (VS-6063) when administered in combination with paclitaxel.~     Pharmacodynamic effects will also be examined in tumor biopsies.~   "
136635|NCT01778790|"~     The investigators will investigate in a sham controlled staggered onset design antidepressant~     effects and safety of deep brain stimulation (DBS) to the superolateral branch of the main~     medial forebrain bundle (slMFB).~   "
136636|NCT01778777|"~     The primary safety objective is to demonstrate that severe device-related complication~     (Serious Adverse Device Effect = SADE) occur within 2 years after prosthesis implantation at~     a rate of less than 2%. Such adverse events include (but are not limited to) revisions due to~     dislocation or glenoid loosening, septic arthritis and scapular fractures requiring surgical~     repair.~   "
136637|NCT01778764|"~     The investigators will learn from this study if the CyberKnife radiosurgery (CK RS) treatment~     of patients with 1-3 versus 4 or more brain metastases results in the same overall survivals.~     The importance of this new knowledge will be to determine the treatment efficacy of CK RS~     with 1-3 versus 4 or more brain metastases. The outcome of this trial would give data to~     support either the continuation or modification of the CK RS treatment of patients with brain~     metastases.~   "
136638|NCT01778751|"~     This study will determine whether Home Telehealth-based implementation of an evidence-based~     intervention targeting Veterans with persistent poorly-controlled diabetes can improve~     hemoglobin A1c, patient self-management, and comorbid depressive symptoms in this high-risk,~     high-cost population. If effective, this intervention (Advanced Comprehensive Diabetes Care)~     offers a feasible, sustainable, and generalizable approach to managing Veterans with~     persistent poorly-controlled diabetes, which can be implemented using only existing Home~     Telehealth services.~   "
136639|NCT01778738|"~     Glycaemia, insulin secretion and action in morbidly obes subjects with type 2 diabetes after~     sleeve gastrectomy ond Roux-en-Y gastric bypass: A randomised single centre study.~   "
136640|NCT01778725|"~     Premature breaking of the amniotic fluids during pregnancy caries high risk for infection of~     the amniotic fluid. One of the results of chorioamnionitis is brain injury of the fetus.~     Fetus' brain is highly vulnerable and could be harmed even by mild inflammation before~     fulminant infection is developed. The aim of this study is to identify, as early as, possible~     signs of brain injury. S100B protein will be used as a marker for brain insult. S100b level~     were associated with the occurrence and size of stroke and brain trauma in adults and~     children. Moreover, S100B crosses the membrane and its level in women with preterm labor was~     associated with brain injury of preterm infant.~      The study question is whether the levels of S100B in women with early amniotic fluids~     breakdown are associated with future brain injury of the infant, as assessed by head~     ultrasound and neurological examination.~   "
136641|NCT01778712|"~     The aim of this study is to develop an intervention that will produce a sustained improvement~     in physical activity and chronic stress as a means to slow the menopause-related accumulation~     of visceral adipose tissue in mid-life women.~   "
136664|NCT01778413|"~     The main objective is to determine the feasibility of maintaining virologic suppression on~     standard plasma viral load by dose reduction of ATRIPLA ®.~   "
137302|NCT01770054|"~     A recent epidemiologic survey demonstrated a high prevalence of type 2 diabetes mellitus in~     Atahualpa residents. Now, the investigators attempt to evaluate the prevalence of the~     metabolic syndrome in adults aged 40 years or more living in this rural village of coastal~     Ecuador.~   "
136642|NCT01778699|"~     In a previous study the efficacy of Lb CD2 on interim covariates related to caries~     development was tested. So, it was decided to plan a new study on schoolchildren from the~     same area. The aim of the present research protocol was to evaluate the anticariogenic effect~     of probiotics daily used, on the caries development in children. The null hypothesis was that~     the probiotic Lb CD2 would not modify the caries risk of the children. Moreover, the study~     will be carried out to investigate the plaque acidogenicity in situ following the regular~     consumption of a probiotic product compared to a control group.~      Objective: To determine the effect of a regularly consumed probiotic on the development of~     new caries lesions.~      Study design: Double blind, placebo-controlled, longitudinal study, monocentric, national, in~     situ~   "
136643|NCT01778686|"~     The serotonin 2A (5-HT2A) receptor is the most abundant excitatory serotonin (5-HT,~     5-hydroxytryptamine) receptor in the human brain, and multiple positron emission tomography~     (PET) studies have investigated the 5-HT2A receptors in the human brain using antagonist~     radioligands. However, the currently available antagonist PET radioligands bind the total~     pool of 5-HT2A receptor receptors whereas a 5-HT2A receptor agonist binds the high-affinity~     subgroup of the receptors which are also G-protein coupled, and thus hypothesized to be the~     functional relevant population of receptors. At the Center for Integrated Molecular Brain~     Imaging (CIMBI), a novel agonist PET radioligands for brain imaging of 5-HT2A receptors was~     recently validated in animals (Ettrup et al. 2011, EJNMMI). In the human brain, [11C]Cimbi-36~     was validated as a selective 5-HT2A receptor agonist PET radioligand through a blocking study~     with the 5-HT2A receptor antagonist pharmaceutical ketanserin. In this validation study, the~     biodistribution and kinetic modelling of [11C]Cimbi-36 binding in the human brain was also~     validated. With these studies, investigators will test the most promising of these,~     [11C]Cimbi-36, in clinical trials, where it will provide a novel method for detecting~     dysfunction in the 5-HT system. The specific aim of this clinical trial is:~      - To examine the effect of acute alterations in 5-HT levels on cerebral [11C]Cimbi-36 binding~     in healthy volunteers who will be PET-scanned at baseline and after pharmacological or~     dietary interventions that either increase or decrease cerebral 5-HT levels.~      It is hypothesized that this novel agonist radioligand will provide both a more physiological~     relevant measure of the 5-HT2A receptors and also reflect levels of cerebral 5-HT in humans,~     more specifically:~      BP will decrease after pindolol and selective serotonin reuptake inhibitor (SSRI) treatment~     and increase after acute tryptophan depletion (ATD). Placebo will leave binding potential~     (BP) unchanged.~   "
136644|NCT01778673|"~     Background: Although fractures of the distal radius are the most common skeletal injury, the~     utility of the available classification systems to predict fracture stability is limited. We~     studied if cortical comminution and intra-articular involvement can assess instability in~     fractures of the distal radius.~      Methods: A prospective multicenter study was conducted. Distal radius fractures in 417~     skeletally mature patients (428 fractures) were studied. Fractures were divided into~     osteoporotic or non-osteoporotic according to age of the patients. Antero-posterior and~     lateral plain radiographs determined if the fractures were minimally displaced or displaced.~     The fracture patterns were evaluated depending on the presence and the site of cortical~     comminution and intra-articular involvement according to a new classification system~     (Buttazzoni classification). Minimally displaced fractures were treated with cast~     immobilization. Displaced fractures underwent closed reduction with subsequent cast~     immobilization. Radiographs were obtained after reduction, at 10-14 days and after 3 months.~     Displacement was classified as primary instability, secondary instability or late~     instability. Endpoints were union of the fracture or re-displacement. Results: Volarly~     comminuted fractures (Buttazzoni 4) displaced in 96 %, intra-articular fractures (Buttazzoni~     3) in 72%, dorsally comminuted fractures (Buttazzoni 2) in 73% and non-comminuted (Buttazzoni~     1) in 16 % of the cases. One third of the initially minimally displaced fractures did not~     maintain acceptable alignment. All initially displaced volarly comminuted fractures were~     unstable. In both initially displaced and minimally displaced fractures, cortical comminution~     and intra-articular involvement were predictive for primary, secondary and late instability.~      Conclusions: Cortical comminution and intra-articular involvement seem to be valuable~     instruments for assessing stability at initial presentation of distal radius fractures. Level~     of Evidence: Level I, prospective multicenter study. Prognostic study.~   "
136645|NCT01778660|"~     This study compares standard versus mnemonic counseling for the treatment of fecal~     incontinence. A mnemonic is a word or rhyme used to aid memory. Our hypothesis is that women~     randomised to mnemonic counseling will higher recall of treatments, satisfaction with the~     physician visit and greater improvement in their quality of life when compared to women who~     received standard counseling.~   "
136646|NCT01778647|"~     Multiple forms of Omega-3 Fatty acids have been used to investigate the role of this food~     supplement in children with ADHD. No clear evidence for their role in this disorder is yet~     available.~      We will conduct a prospective, randomized, double blind, placebo controlled trial to obtain~     significant results regarding this question.~   "
136647|NCT01778634|"~     The purpose of this study is to determine whether intravenous azithromycin is effective in~     eradicating Ureaplasma respiratory tract infection in preterm infants born at 24 to 28 weeks~     gestation.~   "
136648|NCT01778621|"~     Acupuncture at follicular phase of the cycle may improve the pregnancy rate. This study aims~     to compare assisted reproduction outcome between two groups of infertile PCOS patients~     underwent IVF, one group received acupuncture and other group without acupuncture.~   "
136649|NCT01778608|"~     Sedation is often administered to relieve anxiety and discomfort during uncomfortable~     procedures in elderly patients. Patient control of sedation offers many potential benefits~     for patients and healthcare professionals, including improved safety and patient~     satisfaction. The investigators overall goal is to develop a patient controlled intravenous~     sedation system that is effective but very safe for the patient, and requires minimal~     supervision by a doctor or nurse. To fulfill these criteria, a sedation system should~     incorporate fail-safe safety mechanisms. A key safety-critical component is a method of~     objectively assessing the degree of sedation of the patient, and of preventing him from~     self-administering unsafe doses of the sedative drug. The investigators have designed a new~     sedation system that uses a measure of the speed of response of the patient to a defined~     non-noxious stimulus to determine whether or not it is safe to allow him to self-administer~     further levels of sedation. Before being able to execute a volunteer study in order to~     determine a rational selection of optimal threshold response time, a feasibility test on the~     handset device is required.~   "
136650|NCT01778595|"~     Background:~      - Early detection of colon cancer can improve the chances of successful treatment for most~     people. This approach is especially important if blood is detected in the stool. However,~     much better stool sample tests are needed to find this cancer early. To improve the tests,~     researchers want to collect samples from people who are already being screened for colon~     cancer. This study will collect information and samples from older adults in Shanghai, China.~     These adults will be participating in screening tests for colon cancer.~      Objectives:~      - To collect samples and medical information for colon cancer screening from older adults in~     Shanghai, China.~      Eligibility:~        -  Adults between 50 and 74 years of age who are being screened for colon cancer.~        -  Participants will be recruited from two community health centers in Shanghai, China.~      Design:~        -  Participants will provide information on their medical history and factors related to~          colon cancer. They will respond to questions on use of medications, diet choices (such~          as eating red meat), bowel habits, and other factors.~        -  Participants will collect samples for study. These samples will be collected within 3~          days of the screening visit. Particpants will provide a urine sample and four stool~          samples. They will also use cotton swabs to collect samples from just inside the anus.~          The samples will be returned to the study doctors for research tests that may indicate~          who has colon cancer.~        -  Treatment will not be provided as part of this study.~   "
136651|NCT01778582|"~     Background:~      - Very few people with cancer participate in clinical trials. Some are uncertain about the~     treatment, or are afraid of being treated like a guinea pig. They may also feel that they~     have inadequate information about the trial. One possible way of encouraging people to sign~     up for clinical trials is to improve the informed consent process. Researchers want to~     understand how people read and understand informed consent documents.~      Objectives:~      - To study perspective taking, and to study how people understand the information and~     enrollment process for a clinical trial.~      Eligibility:~      - Healthy volunteers at least 18 years of age.~      Design:~        -  This study will require one study visit.~        -  Participants will watch one of four movie clips. They will be asked to respond to the~          film by looking at it from the main character s perspective. They will then answer~          questions about how the clips made them feel.~        -  Participants will read a sample cancer clinical trial consent form on a computer. The~          computer will record their eye movements while they read the text. They will then be~          asked whether they remember the information in the consent form, and whether they would~          participate in the trial.~        -  No treatment will be provided as part of this study.~   "
136652|NCT01778569|"~     Background:~      - Cardiometabolic diseases are medical disorders that can occur together and affect the~     heart. They increase the risk of developing heart disease and diabetes. One disorder,~     psoriasis, is an inflammation that mostly affects the skin but can affect the entire body.~     Another disorder, atherosclerosis, is a process in which cholesterol is gradually deposited~     on the wall of arteries. This causes arteries to harden and become less flexible. Many cells~     that cause psoriasis also cause atherosclerosis. Researchers want to look at the relationship~     between cardiometabolic diseases and psoriasis.~      Objectives:~      - To study the relationship between psoriasis and cardiometabolic diseases.~      Eligibility:~      - Individuals at least 18 years of age who have psoriasis.~      Design:~        -  Participants will be screened with a physical exam and medical history.~        -  Participants will have up to seven outpatient visits over the 4 years. The first visit~          will be a screening visit. Visits 2 will be12 months after visit 1. Visits 3, 4, and 5,~          will be scheduled yearly for the next 3 years. If participants have a psoriasis flare~          with more severe symptoms, they may have an extra visit. Those who leave the study early~          will have a final visit with the full series of tests.~        -  At visits 1, 2,and 5, and any flare visits, participants will have a physical exam and~          medical history. They will provide blood and urine samples, as well as optional tissue~          biopsies. They will also have heart function tests. Imaging studies, as well as optional~          photographs of affected areas, will be performed. These tests will also be performed at~          the final visit.~        -  At visits 3 and 4, participants will have a physical exam and medical history. They will~          also provide blood and urine samples, and have heart function tests.~   "
136653|NCT01778556|"~     Background:~      - Lipodystrophy is a condition where people do not have enough fat in the body. People with~     lipodystrophy can have problems such as diabetes or an enlarged liver. Researchers are~     looking at how leptin, a hormone produced by fat cells, can help people with these problems.~     Leptin helps control appetite and how the body stores food. Taking leptin can help people~     with lipodystrophy eat less food, which may help treat diabetes and other problems. To better~     understand how leptin works, researchers want to do an inpatient study on leptin treatment in~     people with lipodystrophy.~      Objectives:~      - To study how leptin treatment affects lipodystrophy.~      Eligibility:~      - Individuals between 14 and 70 years of age who have lipodystrophy.~      Design:~        -  All participants will have a 19-day stay at the National Institutes of Health Clinical~          Center. One group of participants will have tests for 5 days before starting to take~          leptin. They will then take leptin for 2 weeks, and have more tests. The other group of~          participants will have tests for 5 days while taking leptin. They will then take stop~          taking leptin for 2 weeks, and have more tests, and then they will start taking leptin~          again.~        -  Participants will have regular blood and urine tests during the visit. Some of the blood~          tests will look at insulin levels. Some will look at how the body metabolizes sugar and~          fat. Other tests will check hormone levels, especially of reproductive hormones.~        -  During the visit, participants will spend 3 separate days in a metabolic chamber, a~          special room that measures how many calories the body uses. Urine samples will be~          collected during these stays.~        -  Participants will also have several body imaging studies, including magnetic resonance~          imaging and a body composition scan.~        -  Physical activity will be tested with an exercise bicycle and an electronic activity~          monitor.~        -  Participants will be asked questions about hunger and comfort levels throughout the~          stay.~   "
136654|NCT01778543|"~     Background:~      - Uveal coloboma is a condition where the eye does not form normally. It occurs early in the~     fetus s development during pregnancy. It can lead to different kinds of eye problems,~     including blindness. Several genes have been linked to coloboma, but the cause of most cases~     is hard to find. Researchers want to study the genes of people who have coloboma and genes~     from their close, unaffected relatives (such as parents and siblings).~      Objectives:~      - To study the genes associated with uveal coloboma.~      Eligibility:~      - Individuals at least 1 years of age who either have uveal coloboma or are an unaffected~     relative (such as a parent or sibling).~      Design:~        -  Participants will have a physical exam and medical history. They will also have a full~          eye exam.~        -  Participants with uveal coloboma may have other exams, such as imaging studies and~          hearing assessments.~        -  All participants will also provide blood and cheek swab or saliva samples for genetic~          testing.~   "
136655|NCT01778530|"~     Background:~      - Glioblastoma is an aggressive type of brain cancer that often resists treatment. TRC105 is~     an experimental drug that blocks the growth of new blood vessels. It is being studied for~     possible use in treating different kinds of cancer. Researchers want to see if TRC105 can be~     used to treat glioblastoma that has not responded to standard treatments.~      Objectives:~      - To test the safety and effectiveness of TRC105 in adults who have glioblastoma that has not~     responded to standard treatments.~      Eligibility:~      - Individuals at least 18 years of age who have glioblastoma that has not responded to~     standard treatments.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Imaging studies and other tests will be used to study the~          tumor before the start of treatment.~        -  Participants will have 28-day (4-week) cycles of treatment.~        -  Participants will have TRC105 intravenously once a week. The first infusion will take~          about 4 hours. The length of time needed for the infusion may be slowly reduced if it is~          well tolerated.~        -  At the end of the first cycle (the first 4 weeks), the imaging studies will be repeated~          before continuing TRC105.~        -  Participants will take TRC105 for as long as the tumor does not grow and the side~          effects are not too severe. They will have imaging studies at the end of every cycle to~          evaluate the tumor.~   "
136665|NCT01778400|"~     Ultrasound-guided ethanol ablation is an effective treatment modality for patients with~     cystic thyroid nodules (cystic portion > 90%); however it is less effective in predominantly~     cystic thyroid nodules (90% > cystic portions > 50%). The volume reduction after EA has been~     reported 64% - 69.8% for predominantly cystic thyroid nodules. EA is insufficient for 26%~     (27/103) of patients with predominantly cystic thyroid nodules. Radiofrequency ablation to~     patients with incompletely resolved clinical problems after EA and the mean volume reduction~     ratio was 92% at 6-month follow-up. It is well known that RF ablation is effective in both~     predominantly cystic and solid thyroid nodules. Although RF ablation has effectively treated~     the patients who were unsatisfactory after EA, to the best of our knowledge, no study to date~     has compared these two ablation techniques. Therefore investigators performed a prospective~     randomized study to compare single-session RF ablation and EA for treating predominantly~     cystic thyroid nodules.~   "
136656|NCT01778517|"~     Background:~      - Functional movement disorder (FMD) is a form of conversion disorder (CD). CD is a disorder~     in which a person has neurological symptoms that do not have a neurological cause. These~     symptoms can include pain, weakness, dizziness, and fatigue. Some thoughts on CD suggest that~     it may come from feelings of anxiety that are converted into physical symptoms. Treatment for~     FMD usually involves stress reduction, family help, and regular doctor s appointments.~     Therapy interventions, however, have not been well studied. Researchers want to see if people~     with FMD get better with psychotherapy. They will study two different types of psychotherapy:~     group therapy and a self-help manual.~      Objectives:~      - To test two different types of therapy treatments for FMD.~      Eligibility:~      - Individuals at least 18 years of age who have been diagnosed with FMD by a neurologist.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          have a psychological exam, and answer questions about their mood and symptoms.~        -  Participants will be separated into three groups. One group will have group therapy.~          Another will use a self-help workbook designed for people with FMD, and have individual~          therapy sessions. A third group will just have standard care. During the study,~          participants will continue to see their regular doctor.~        -  Group therapy participants will meet once a week for 6 months at the National Institutes~          of Health clinical center. There will be 8 to 10 people per group. Sessions will last 75~          minutes. These sessions will work on methods for treating FMD.~        -  Self-help workbook participants will have six individual therapy sessions over 3 to 4~          months. They will use the workbooks to learn about and practice methods for treating~          FMD.~        -  All participants will be evaluated at 3, 6, and 12 months during the study.~        -  At the end of the study, participants will have a final follow-up session with exams and~          questions similar to the screening exam. They will return to the care of their regular~          doctor.~   "
136657|NCT01778504|"~     Background:~      - Many psychiatric, behavioral, and developmental disorders are genetic. This means that they~     tend to run in families. Some begin in childhood, while others do not appear until adulthood.~     Researchers want to look at people of all ages who have these disorders that started in~     childhood. They will also look at relatives of people with these disorders. This information~     will allow doctors to learn more about childhood behavioral problems and how they are~     inherited. It may also help doctors treat those disorders.~      Objectives:~      - To study the onset and treatment of childhood behavioral, psychiatric, and developmental~     disorders.~      Eligibility:~        -  Individuals of any age who have a psychiatric, autism spectrum, or developmental~          disorder, or other behavioral problems.~        -  Family members of individuals with the above disorders. This group may include parents,~          grandparents, siblings, aunts/uncles, cousins, and children.~      Design:~        -  Participants will be screened with a medical history and physical exam. They will have a~          psychiatric history with tests of thinking, judgment, and behavior. Blood and urine~          samples will be collected. Brain imaging scans will be performed to look at brain~          function. They may have a spinal tap to collect cerebrospinal fluid.~        -  Relatives will have a medical history and physical exam. They will also have a~          psychiatric history with tests of thinking, judgment, and behavior. Blood and urine~          samples will be collected. Brain imaging scans will be performed to look at brain~          function.~        -  A relative s exams may reveal a behavioral or other disorder. If so, he or she may~          re-enroll on the study as a person with the disorder.~   "
136658|NCT01778491|"~     Background:~      - Age-related macular degeneration (AMD) is a disease that blurs the sharp vision needed for~     activities such as reading, sewing, and driving. It affects the macula, the center of the~     retina at the back of the eye, which allows a person to see fine detail. Researchers want to~     collect medical histories, eye exam data, and genetic information that may be associated with~     AMD. They want to compare this information with information collected from people without~     AMD.~      Objectives:~      - To collect medical information and gene samples for researchers studying AMD.~      Eligibility:~        -  Individuals between and 60 and 90 years of age who have AMD in at least one eye.~        -  Individuals between and 60 and 90 years of age who have no AMD in either eye.~      Design:~        -  This study will involve one study visit. This study visit will last 6 to 8 hours.~        -  Participants will have the following tests and exams as part of their study visit:~        -  Full physical exam and medical history~        -  Full eye examination~        -  Laser scan of the eye~        -  Retina function test~        -  Vision sensitivity test~        -  Optional blood sample (for genetic study)~        -  No treatment will be provided as part of this study.~   "
136659|NCT01778478|"~     Background:~      - An interview called the Schedule for Affective Disorders and Schizophrenia for School Age~     Children Present and Lifetime version (K-SADS-PL) is used to identify mental health problems~     among children and younger teens. Both the child and a parent are asked questions about the~     child s behaviors and symptoms that might indicate such problems. Researchers want to see if~     the K-SADS-PL can help identify mental health problems in young adults (ages 18 to 25). Two~     groups of young adults, including healthy volunteers and people with cancer, and their~     parents will participate in this study.~      Objectives:~        -  To see if the K-SADS-PL interview used for children and teens can also be used for young~          adults.~        -  To see whether information provided by parents will affect the rate of mental health~          problems found.~      Eligibility:~        -  Individuals aged 18-25 years who have cancer and are participating in research studies~          at the National Institutes of Health.~        -  Healthy volunteers aged 18-25 years.~        -  A parent of a young adult who is participating in this study.~      Design:~        -  This study requires one study visit that includes an interview and self-report~          questionnaires. It will take about 1 to 3 hours. A follow-up phone call or visit will~          also be required.~        -  Young adult participants will be given the K-SADS-PL interview and four questionnaires~          that ask about mood, anxiety, distress, parental contact, and development during~          childhood. The K-SADS-PL interview will be video recorded or audio recorded.~        -  Parents will also be given the K-SADS-PL interview. This interview can be done in person~          or by phone, and will also be recorded.~        -  No treatment will be provided as part of this study.~   "
136660|NCT01778465|"~     Aspirin-Exacerbated Respiratory Disease, or AERD, consists of aspirin sensitivity, asthma and~     nasal polyps. It is currently managed by chronic steroid use, multiple endoscopic sinus~     surgeries and/or aspirin desensitization. However, these treatments have potential adverse~     effects.~      A theory has been postulated that decreasing the level of dietary salicylates may help in~     long-term control of disease. A current trial is in the works to evaluate the clinical~     outcomes of decreased salicylate, but measurements of biochemical markers of disease has not~     yet been done. The hypothesis is that decreased dietary salicylates will result in a decrease~     in urinary salicylates and inflammatory markers of disease, cys-leukotrienes, which are~     typically elevated in this disease.~   "
136661|NCT01778452|"~     The aim of this study is to analyse genomics profile expression in endometrium under~     different endometrial priming for recipients.~   "
136707|NCT01777841|"~     The MC Health Connection Discovery trial is designed to determine if a new health information~     system that delviers interactive care plans (delivered by mobile) to patients can impact~     post-surgical recovery.~   "
136666|NCT01778387|"~     The purpose of this prospective paper is to make a comparison between laparoscopic and~     opening approaches in ventral hernia repair, taking into account absence of recurrence in~     long - time (5 years), results centered at patient, especially satisfaction with expectations~     and improvement of normal physical activity, morbidity that particular form must include~     chronic pain, adjusted mortality through co-morbidities and, finally, prospective expenses,~     related to both effectiveness and utility~   "
136667|NCT01778374|"~     In the M-BRiHT study we aim to implement a programme of opportunistic HIV screening in the~     Emergency Department, Mater Misericordiae University Hospital. We hypothesize that such a~     programme will be acceptable in an Irish setting. We also wish to study the factors that~     influence test completion or acceptance. We will utilise informative interactive video media~     via a touch-screen tablet device to provide pre-test counselling and then offer rapid~     minimally invasive testing with a cotton-bud type swab of the buccal mucosa. In doing so we~     will to determine absolute numbers of those attending the ED who consent to watching the~     interactive information video about rapid HIV test screening. We will describe the absolute~     number and proportion of those who watch the interactive video who subsequently proceed to~     have the rapid HIV test. The primary aim is to determine the cultural, gender and ethnic~     factors which influence the completion of such rapid HIV testing with the future objective of~     maximising test completion in this crucial public health area.~   "
136668|NCT01778361|"~     Despite the prevalence of osteopenia and osteoporosis in the HIV positive population,~     relatively little is known about the underlying pathology. This prospective cohort study aims~     to gain further understanding about a number of issues relating to low bone mineral density~     in HIV-infected subjects.~   "
136669|NCT01778348|"~     Type 1 diabetes (T1D) is one of the most common chronic childhood diseases requiring lifelong~     insulin therapy. Children and adolescents with T1D need regular insulin injections or the~     continuous insulin delivery using an insulin pump in order to keep blood glucose levels~     normal. We know that keeping blood sugars in the normal range will help prevent longterm~     diabetes-related complications involving the eyes, kidneys and heart. However, achieving~     treatment goals can be very difficult as the tighter we try to control blood glucose levels,~     the greater the risk to develop symptoms and signs of low glucose levels (hypoglycaemia).~     This is a particular problem at night and one solution is to develop a system whereby the~     amount of insulin injected is controlled by a computer and is very closely matched to the~     blood sugar levels on a continuous basis. This can be achieved by what is known as a~     closed-loop system where a small glucose sensor placed under the skin communicates with a~     computer containing an algorithm that drives an insulin pump. We have been testing such a~     system in Cambridge over the last five years in children and have found that this system is~     effective at maintaining tight glucose control and preventing nocturnal hypoglycaemia. More~     recently the system has been tested in real life conditions in the home setting for three~     weeks during a pilot single-centre study.~      The next step is to extend the evaluation of closed-loop over a prolonged period of three~     months. In the present study we are planning to study 24 young people aged 6-18 years on~     insulin pump therapy. During three months glucose will be controlled by the computer and~     during the other three months the subjects will make their own adjustments to the insulin~     therapy using real-time continuous glucose monitoring.~      We aim to determine the effect of the computer algorithm in keeping glucose levels between~     3.9 and 8 mmol/L (normal levels). Safety evaluation comprises assessment of the frequency of~     severe hypoglycaemic episodes. Participants' response to the use of the system in terms of~     lifestyle change, daily diabetes management and fear of hypoglycaemia will be assessed. We~     will also test for longer term glucose control by measuring glycated haemoglobin (HbA1c).~   "
136670|NCT01778335|"~     The purpose of the study is to understand whether a new treatment of stroke - endovascular~     clot removal - can be added to the current standard of care to improve patient outcomes.~      All patients will receive the best standard stroke treatment. This includes treating patients~     with the clot dissolving drug tPA (tissue plasminogen activator). However, t-PA does not work~     in some patients and others are not eligible to receive t-PA because they present too late~     for treatment (they woke up with their stroke symptoms or their stroke was not witnessed).~      During endovascular revascularization the blockage in the artery is removed with the use of~     devices called stentreivers and or by giving clot dissolving drug at the site of the blockage~     in the artery to restore blood flow. Stentrievers are devices that have been designed by~     different companies to remove blood clots from arteries.~      Up to a maximum of 500 people at 20-25 hospitals across Canada and other countries will~     participate in this study.~   "
136671|NCT01778322|"~     The objective of this clinical study is to evaluate clinical utility of the WEB Aneurysm~     Embolization System used to embolize intracranial aneurysms~   "
136672|NCT01778309|"~     In this investigation the investigators utilized NAC administration to foster GSH~     availability during an 8-day period following eccentric exercise-induced muscle damage in~     order to test our hypotheses: i) antioxidant supplementation does not disturb performance and~     adaptations induced by exercise-induced muscle injury and ii) redox status perturbations in~     skeletal muscle are pivotal for the regulation of muscle' inflammatory response and repair.~   "
136673|NCT01778296|"~     The dorsum of the finger is a reliable flap donor site in reconstructive hand surgery because~     of its similar quality to the original. The dorsal digital island flap can be used for~     repairing the defect of adjacent finger, but the limited length of the pedicle precludes its~     use for a more distal defect. The heterodigital neurocutaneous island flap of the dorsal~     branch of the digital nerve can be used as an alternative to resolve this problem.~   "
136674|NCT01778283|"~     The purpose of this study is to detemine whether effect of Acetate-free solution on cardiac~     index and cardiac output measured by saline dilution techniques compares with Acetate-based~     solution in online-hemodiafiltration~   "
136675|NCT01778270|"~     This study investigates if data about monitoring the drainage of pleural effusion can be~     collected by non invasive sensors (feasibility).~   "
136676|NCT01778257|"~     Obesity is a major health issue worldwide; there is a constant raise in obesity related death~     each year.~   "
136677|NCT01778244|"~     Almost all antipsychotics can induce dyslipidemia, but no treatment has been established.~     Metformin can improve lipid levels in obese patients. The investigators conducted a~     randomized, placebo-controlled study to test the efficacy of metformin for~     antipsychotic-induced dyslipidemia.~   "
136678|NCT01778231|"~     This study aims to investigate genetic and environmental determinants of macular pigment (MP)~     and assess the effects of lutein and zeaxanthin-rich supplements on macular pigment levels.~   "
136679|NCT01778218|"~     This study will assess the safety and tolerability of the investigational radiolabeled~     imaging agent technetium-99m-labeled ethylenedicysteine-deoxyglucose (99mTc-EC-DG).~     Additionally, the study will determine the specific times to best image the heart using a~     SPECT camera with the investigational imaging agent and compare the images to those taken~     while undergoing the standard rest and exercise/regadenoson testing previously performed to~     detect the presence and severity of Coronary Artery Disease (CAD).~   "
136680|NCT01778205|"~     The recent fall in birth and death rates has led to demographic changes such as low fertility~     and high life expectancy . The WHO reports the median age of the European population to be~     the highest in the world and predicts that the proportion of over-60s in will increase from~     14% in 2010 to 25% in 2050. There is wide variability in the quality of health and well-being~     in the ageing population. Longevity with a good quality of life is a consequence of the~     combination of an individual's genes, nutrition, environment, lifestyle and medical~     interventions. There is increasing evidence that research into healthy ageing needs to start~     with early life data to capture all traits and exposures experienced by an individual~     throughout life. Epigenetic imprinting occurs both in utero and during early postnatal~     development. Maternal environmental exposures, including nutritional status, may have a~     permanent effect on the developing foetus by influencing epigenetic profiles and leading to~     life-long genome adaptation. Numerous reports show that restricted intra-uterine growth due~     to poor maternal nutrition during pregnancy increases risk in the offspring of developing~     mental disorders, metabolic syndrome, cardiovascular disease or stroke in later life. To~     understand the basic mechanisms and interactions through which the ageing phenotype develops,~     systems involved in key processes of early development must be considered as well as those~     crucial to health in older persons. The Reus and Tarragona Birth Cohort is a longitudinal~     study. In the first phase, blood is collected from pregnant women at <12, 15, 24-27 and 34~     gestational weeks (GW) and at labor and from the cord. Detailed lifestyle, habits and~     supplement use data are collected at 20 and 32 gestational weeks and on nutritional habits at~     <12GW and at birth. Placental vascular function is assessed at 20 and 32 GW by analysis of~     Doppler waveforms of the uterine arteries. Data on pregnancy evolution and outcome are also~     recorded. The first phase investigates the association between gene-environment (nutrient and~     lifestyle habits) interactions and fetal growth and pregnancy outcome. The second phase of~     the study follows up the children at 7.5 years of age. Growth, exercise and nutritional~     habits as well as environment and cognitive development are assessed. The aims are to~     investigate the association between gene-environment interactions associated with healthy~     development from early pregnancy until 7.5 years of age.~   "
136681|NCT01778192|"~     Adequate bowel cleansing is important for a completeness of colonoscopy and detection of~     colon polyps. Inadequate bowel preparation leads to longer duration of colonoscopy and~     obscured mucosal visualization resulting in missed lesions.~      Bowel cleansing agents are simply classified into the large volume, iso-osmotic polyethylene~     glycol (PEG) based solutions or the small volume osmotically active agents, such as sodium~     picosulphate with magnesium citrate (SPMC).~      There are rare reports that compare directly conventional polyethylene glycol (PEG) solution~     and sodium picosulphate with magnesium citrate (SPMC) for bowel preparation in korea.~      The aim of this study is to compare the efficacy, safety, and tolerability of different~     regimens of SPMC and PEG solution.~   "
136682|NCT01778179|"~     To evaluate safety and efficacy of Tri-Luma® cream as an adjunctive treatment to cryotherapy~     when used in the pre- and post-procedure phases for the treatment of solar lentigines on the~     back of the hands and in the prevention of post-inflammatory hyperpigmentation after~     cryotherapy.~   "
136683|NCT01778166|"~     Patients with gastrointestinal(GI) malignancy usually suffer from malnutrition and suppressed~     immune function, which might be worsened by major elective surgery.Enteral nutrition has been~     emphasized for patients with GI malignancy during the perioperative period to accelerate~     bowel function recovery, and improve nitrogen balance and immune response while reducing~     postoperative complications and hospitalization time.Early enteral nutrition(EEN) can promote~     the postoperative recovery of GI function and has been considered to have other advantages~     such as the reduction of medical cost and maintenance of intestinal barrier function.~     Immunonutrition containing special compounds like omega-3-unsaturated fatty acids has been~     put forward to modulate the immune response and improve the immune function in patients with~     cancer, which may have an better effect on the immune system than standard enteral nutrition.~     However, studies on immuno-enhanced early enteral nutrition after a resectable GI malignancy~     surgery are scarce.~      The aim of this study was to determine whether immuno-enhanced early enteral nutrition(IEEN)~     is more effective than standard early enteral nutrition(SEEN) on nutritional status, immune~     function, surgical outcomes,time to adjuvant chemotherapy and days of hospitalization after~     laparoscopic GI surgery.~   "
136684|NCT01778153|"~     The purpose of this study is to compare the Equinox Personal Coaching exercise training~     method to self-directed exercise training in helping subjects become more fit. Men between 30~     and 44 years of age who exercise on a regular basis and are interested in receiving Equinox~     personal training will be invited to participate. The investigators will enroll 36 subjects~     at University of California, Los Angeles (UCLA), the only site. The hypothesis of this study~     is that subjects randomized to the Personal Coaching Method will result in significantly~     greater lean mass accrual than those randomized to self-directed training over the 12 weeks~     of the study.~      Subjects will have 2 Baseline visits over 1 week, then be randomized to receive either~     Coached training or self-training, which they will do for 12 weeks, then complete two End of~     Study visits over the final week. Visits 1 and 3 include questionnaires, skinfold fat/lean~     body mass measurements, and strength and aerobic performance tests, and will take place at~     Equinox. Visits 2 and 4 include a DEXA scan and ECG, which will take place at UCLA.~   "
136685|NCT01778140|"~     The investigators hypothesize that a Clinical Decision Support System (CDSS) designed with~     Patient-Specific reminders yields superior performance than that with~     Non-patient-specific reminders in preventing contrast-induced nephropathy.~   "
136686|NCT01778127|"~     Five year survival following a diagnosis of childhood cancer has reached 83%, making long~     term health outcomes among survivors an important concern. The growing population of~     survivors is at an increased risk of physical inactivity and associated adverse health~     outcomes. Regular physical activity is associated with better cardiovascular and~     musculoskeletal health. Despite the known benefits of physical activity, nearly half of all~     childhood cancer survivors do not meet recommended guidelines for physical activity.~      Researchers at St. Jude Children's Research Hospital (SJCRH) want to determine if a~     rewards-based physical activity intervention delivered via an interactive website among young~     adolescent childhood cancer survivors, aged 11 through 14 years, will increase physical~     activity levels and improve cardiovascular and musculoskeletal health. The investigators also~     want to learn if this rewards-based intervention is effective. To achieve this goal the~     investigators have designed a three-arm prospective, randomized study with two reward-based~     intervention groups and a control group.~   "
136687|NCT01778114|"~     The purpose of this study was to determine whether vitamin D2 and vitamin D3 in orange juice~     are effective at raising vitamin D levels in the blood and if vitamin D2 and vitamin D3 in~     orange juice raised blood levels of 25(OH)D as well as vitamin D3 and vitamin D2 supplements.~   "
136688|NCT01778101|"~     This study is pilot study to evaluate safety and efficacy of lansoprazole in preterm infants~     with gastroesophageal reflux documented by 24hr pH impedance monitoring~   "
137303|NCT01770041|"~     This observational study will assess the metabolic pathways of paracetamol that are utilised~     after liver resection.~   "
136689|NCT01778088|"~     The purpose of this study is to determine the recommended dosing of I-131-CLR1404, a~     radiolabeled therapy compound, for treating subjects with glioma.~      Subjects who meet study entry criteria will receive I-131-CLR1404. For each subject, the~     study will be conducted in three phases, dosimetric, therapy, and follow-up. In the~     dosimetric phase, subjects will receive one 5 mCi dose of the study drug and undergo whole~     body imaging on on the day of infusion and on post-infusion days 2, 3, and 7 for assessment~     of biodistribution and tumor uptake of I-131-CLR1404. If normal and expected biodistribution~     are demonstrated, the subject will begin the therapy phase. In the therapy phase, the~     subjects will receive a dose based on body surface area and may receive additional doses if~     they meet dosing criteria. After the last treatment dose, subjects will enter the follow-up~     phase and will be followed monthly.~      All subjects will be prescribed thyroid protection medication to be taken 24 hours prior to~     injection of the dosimetric dose, and continuing for 14 days after the administration of the~     therapy dose.~   "
136690|NCT01778075|"~     The purpose of this study is to evaluate the bioequivalence of a newly developed ULTRACET~     extended-release (ER) tablet of tramadol hydrochloride and acetaminophen, to the current~     marketed ULTRACET ER tablet, in healthy participants under fasted condition.~   "
136691|NCT01778062|"~     This clinical study will assess efficacy and safety of indacaterol (150㎍ o.d.) in patients~     with Chronic Obstructive Pulmonary Disease (COPD) with destroyed lung by tuberculosis.~   "
136692|NCT01778049|"~     The objective of the study is to investigate the efficacy, safety and tolerability of~     linagliptin 5 mg qd compared to placebo given for 24 weeks in inadequately controlled T2DM~     patients on empagliflozin 10 mg or 25 mg and maximum tolerated dose of metformin. The primary~     objective of efficacy evaluation is planned after 24 weeks of treatment. The study is~     designed to show superiority of the combination of empagliflozin and linagliptin over~     empagliflozin alone.~   "
136693|NCT01778036|"~     The primary purpose of this study is to investigate if there is altered motor control of head~     and neck in chronic neck pain patients compared with healthy persons. In addition,~     associations between neck pain, motor control, disability and function, and clinical symptoms~     will be studied in patients following physiotherapy treatment in primary health care.~   "
136694|NCT01778023|"~     This trial is conducted in Asia. The aim of this trial is to evaluate the efficacy and safety~     of recombinant human growth hormone (hGH) in subjects with idiopathic short stature in Korea.~   "
136695|NCT01778010|"~     Modafinil has been reported to reduce cocaine use in a clinical sample of infrequent users (2~     days/week), but the effects of modafinil on cocaine self-administration in the laboratory~     have not been studied. The present study investigated the effects of modafinil maintenance on~     cocaine self-administration by frequent users (4 days/week) under controlled laboratory~     conditions. During this 48-day double-blind, crossover design study, the effects of modafinil~     maintenance (0, 200, and 400mg/day) on response to smoked cocaine (0, 12, 25, and 50 mg) were~     examined in nontreatment seeking cocaine-dependent individuals (n = 8).~   "
136696|NCT01777997|"~     This study was done with people who were infected with HIV, but did not show any signs of~     having HIV. They were also feeling well without taking HIV medication and had low or~     undetectable levels of the virus in the blood. The purpose of this study was to see if taking~     HIV medication (antiretroviral therapy [ART]) would reduce immune activation (a signal that~     the body is fighting an infection) in people who have HIV, but did not show symptoms. Also~     this study helped determine how safe the drug was and how well people reacted to the drug.~      For this study, the following antiretroviral therapy (ART) was be provided in the form of a~     single tablet that contains three different drugs: emtricitabine/rilpivirine/tenofovir~     disoproxil fumarate (FTC/RPV/TDF). These drugs were combined as one tablet which was approved~     by the Food and Drug Administration (FDA) as a single pill to treat HIV infection. The HIV~     medication provided was one of the recommended treatments for HIV, including people with low~     viral loads (how much HIV you have in your body) who were taking HIV drugs for the first~     time. The risks seen with this HIV medication were the same that one would encounter when~     taking these drugs outside of the study.~   "
136697|NCT01777984|"~     The purpose of this study is to determine the relationship among the body fat distribution,~     especially the visceral fat, in patients with age-related macular degeneration in comparison~     to patients with a normal fundus.~   "
136698|NCT01777971|"~     Ascites is the accumulation of fluid within the peritoneal cavity of the abdomen. It is a~     frequent complication of cirrhosis that is associated with significant morbidity and poor~     quality of life. Large-volume ascites has been associated with impaired pulmonary function.~     In a previous study, the presence and severity of ascites were determined to be significant~     determinants of fatigue.~      In this study, we will determine whether large-volume ascites contributes to fatigue by~     assessing the response to drainage of ascites by means of a procedure called large-volume~     paracentesis. We hypothesize that treatment of ascites with a single large-volume~     paracentesis leads to decreased fatigue and improved quality of life and that this~     improvement is associated with improved sleep pattern.~      20 patients with cirrhosis with refractory ascites requiring regular drainage of ascites~     fluid by large-volume paracenteses will be recruited for the study. All patients will undergo~     a complete clinical and physical examination for liver function, including blood tests.~     Hepatic encephalopathy, a change in mental status associated with liver dysfunction, will be~     assessed by obtaining historical data and by means of simple bedside neuropsychological~     examinations.~      Study visits will take place on two consecutive days, with each visit lasting approximately~     2-3 hours. Immediately prior to a large-volume paracentesis, patients will complete~     standardized questionnaires for fatigue severity, quality of life, quality of sleep, and a~     physical assessment of fatigue by means of a 6-minute walk test. Repeat evaluations will be~     performed 1 day after the procedure. Statistical analysis will then be performed to determine~     the effect of the paracentesis on the various clinical assessments.~   "
136708|NCT01777828|"~     Register multicenter, prospective, open, non-randomized implantation of percutaneous aortic~     bioprostheses through for the treatment of severe degenerative aortic stenosis~     Epidemiological data and the 1-year survival of aortic bioprostheses implanted by~     percutaneous.~   "
136709|NCT01777815|"~     The purpose of this study is to demonstrate the safety and performance of the NeoChord DS1000~     Artificial Chordae Delivery System in implanting ePTFE sutures(s) as artificial neochordae in~     patients with mitral regurgitation.~   "
136699|NCT01777958|"~     This observational study will evaluate the efficacy, safety and patient reported quality of~     life of palliative first-line Perjeta (pertuzumab) in combination with Herceptin~     (trastuzumab) in patients with HER2-positive advanced breast cancer (metastatic or locally~     recurrent, inoperable) who relapsed after completed adjuvant Herceptin therapy. Additionally,~     information on selection criteria of breast cancer patients treated first-line with Perjeta,~     Herceptin and chemotherapy and their treatment duration will be collected and analyzed. Data~     will be collected from eligible patients for up to 20 months of treatment and 24 months of~     follow-up.~   "
136700|NCT01777945|"~     This multicenter observational study will evaluate the efficacy and safety of Xeloda~     (capecitabine) in combination with docetaxel in first-line therapy in participants with~     HER2-negative metastatic breast cancer. Participants will be followed for approximately 6~     months of treatment.~   "
136701|NCT01777932|"~     This multicenter, single-arm observational study will evaluate the clinical benefits of~     Avastin (bevacizumab) in combination with paclitaxel in first-line treatment in patients with~     metastatic breast cancer. Patients with metastatic breast cancer who have started Avastin~     treatment within 6 months prior to study start will also be eligible. Data will be collected~     from patients for up to 5 years.~   "
136702|NCT01777919|"~     Glioblastoma multiform (GBM) is the most common malignant primary brain tumor in adults.~     Despite maximal treatment tumor relapse occurs regularly accompanied by unfavourable~     prognosis. Among other reasons, it is believed that this could be in part due to the~     existence of the so-called tumor stem cells (TSCs), a cellular subfraction within GBM which~     escape therapy by being highly resistant to irradiation and chemotherapy and thus~     constituting the source of tumor recurrence.~      GBM, like many other cancers, show a sub-population of aldehyde dehydrogenase (ALDH)~     overexpressing TSCs. More specifically, ALDH1A1, a cytoplasmatic isoform of ALDH, proved to~     be a novel stem cell marker in human GBM. In addition, ALDH1A1 has been shown to be a~     mediator for resistance of GBM to temozolomide (TMZ) and a reliable predictor of clinical~     outcome; prognosis of patients with a high level of ALDH1A1 expression was poor compared with~     that of patients with low levels. Consequently, ALDH1A1 may serve as a potential target to~     improve treatment of human GBM through inhibition of the enzyme.~      Disulfiram (DSF) has been used for more than sixty years in the treatment of chronic~     alcoholism because of the unpleasant symptoms it provokes after ethanol intake. The~     underlying mechanism is believed to be the accumulation of acetaldehyde in the blood, due to~     inhibition of the liver ALDHs. Actually, DSF is a strong inhibitor of ALDH1A1 and relatively~     non-toxic at therapeutic (for chronic alcoholism) doses that can penetrate the blood-brain~     barrier. In addition, DSF has been shown to be cytotoxic on GBM stem-like cells, inhibiting~     the growth of TMZ resistant GBM cells and blocking self-renewal by ~100% , while it has been~     identified as an inhibitor of human GBM stem cells in high-throughput chemical screens.~     Interestingly, a number of these actions were copper-dependent.~      In the current Phase II clinical trial, DSF/copper combination will be tested as an~     adjunctive and concurrent chemotherapy in the treatment of newly diagnosed GBM. According to~     our hypothesis, initiation of DSF chemotherapy after the resection of the tumor and before~     the introduction of the standard radio-chemotherapy will inhibit ALDH1A1 of GBM TSCs making~     them more susceptible to radio-chemotherapy and possibly reducing the recurrence rate of GBM.~     On the other hand, the addition of copper will probably enhance the cytotoxic effects of DSF~     possibly through augmentation of its pro-apoptotic and proteasomal inhibitory actions.~   "
136703|NCT01777906|"~     Topical nasal steroid sprays are the mainstream treatment for patients with nasal polyps.~     Polyps tend to recur after surgery and topical nasal steroid sprays are used as the primary~     medical management to prevent continued growth. More recently high dose topical nasal steroid~     sprays are used. It is thought that the higher dose will penetrate the sinus cavities at an~     increased dose and will allow for greater control of polyp growth. Safety studies have been~     performed which have shown no suppression of the pituitary axis with long term high dose~     topical steroid or changes in intraocular pressure. However, studies in efficacy are limited~     despite their widespread use. The objective of this study will be to compare the~     effectiveness of two topical nasal steroid sprays in patients with recurrent nasal polyps.~   "
136704|NCT01777893|"~     Type-2 diabetes is one of the fastest growing chronic diseases worldwide. This trend is~     mainly driven by a global increase in the prevalence of obesity. The PREVIEW study has been~     initiated to find out the most effective lifestyle-components (diet and physical activity) in~     the prevention of Type-2 diabetes. The project consists of a randomized~     lifestyle-intervention with the more specific aim to determine the preventative impact of a~     high-protein and low-GI diet in combination with moderate or high intensity physical activity~     compared with a moderate-protein and moderate GI diet in combination with the same activity~     levels on the incidence of Type-2 diabetes in predisposed, pre-diabetic children, young and~     older adults.~      The trial will be performed in 6 EU countries (Bulgaria, Denmark, Finland, Spain,~     Netherlands, UK) and Australia and New Zealand.~      A total of 2,500 overweight or obese adult participants (25-70 y) as well as 150 children and~     adolescents aged 10—18 y) will be recruited. All adult participants are first treated by a~     low-calorie diet for 8 weeks, with an aim to reach ≥ 8% weight reduction. Children and~     adolescents are treated separately with a conventional weight-reduction diet, with-out a~     specific aim for absolute weight loss.~      The adult participants are randomized into two different diet interventions and two exercise~     interventions for a total of 148 weeks. This period aims at preventing Type-2 diabetes by~     weight-maintenance (prevention of relapse in reduced body weight) and by independent~     metabolic effects of diet and physical activity.~      The primary endpoint of the study is the incidence of Type-2 diabetes in the adults during 3~     years (156 weeks) according to diet (high protein/low-GI versus moderate protein/moderate-GI,~     adjusted for physical activity), based on a 75 g oral glucose tolerance test and/or HbA1c.~      For children and adolescents:~      Change in insulin resistance at 2 years after randomization to high protein versus moderate~     protein diet, measured by insulin resistance analyzed by the homeostatic model (HOMA-IR) as~     well as physiological improvement of health with respect to pre-diabetic characteristics.~      Our hypothesis is that a high-protein, low-GI diet will be superior in preventing type-2~     diabetes, compared with a moderate protein, moderate GI diet, and that high-intensity~     physical activity will be superior compared to moderate-intensity physical activity.~   "
136705|NCT01777867|"~     The aim of this study is to provide pilot data on the possible gastrointestinal predictors of~     respiratory hyper-responsiveness and how these relate to the clinical sub-types of~     gastroesophageal reflux disease (GERD) and visceral acid hypersensitivity.~   "
136706|NCT01777854|"~     The study aims to determine if treating pediatric patients (age 7-17) for four weeks with~     omeprazole prior to tonsillectomy will decrease post tonsillectomy pain. The hypothesis is~     that many patients have silent laryngopharyngeal reflux and by reducing the acid entrance~     into the oropharynx, patients will have less post tonsillectomy pain due to decreased acid~     irritation of the surgical wound (tonsil fossas).~      The study will be a prospective double blind randomized study. Participants will be invited~     to participate in the study by giving the study information at the preoperative assessment,~     when the decision is made to have a tonsillectomy performed. If the patient agrees to~     participate in the study, a written consent and child assent will be obtained and the patient~     will be randomly assigned to a treatment versus control group based on the randomly assigned~     participant number.~      The treatment group will then be given a four week course of omeprazole to be taken for the~     four weeks prior to tonsillectomy. The patient will be given a post tonsillectomy assessment~     form. The form looks at postoperative pain (using a visual analog scale 1-10) as well as oral~     intake at postoperative day 0,1,3,5,7,10, and 14. The form will be turned in at the~     postoperative visit or mailed in.~      The pain level and oral intake between the two groups to will be compared to determine if~     antireflux control helps decrease the postoperative pain after tonsillectomy.~   "
136710|NCT01777802|"~     Success of cancer immunotherapy is limited by the ability of solid tumors to evade local and~     systemic antitumoral immune responses. Several mechanisms of tumor immune evasion have been~     identified, including low intratumor expression of antigens and elevated expression of~     inhibitory co-regulatory molecules. An effective immunotherapy is one which would induce~     necrotic cell death and accompanying proinflammatory cytokine induction. Stereotactic Body~     Radiotherapy (SBRT) or Intensity Modulated Radiotherapy (IMRT) or brachytherapy, which is~     capable of delivering high, conformal radiation doses (>8 Gy) of tumor ablative radiation may~     be an effective means of conditioning a tumor bed to a state favorable to the initiation of~     robust antitumoral immune responses.~   "
136711|NCT01777789|"~     The purpose of the study is to use functional MRI (fMRI) to measure brain connectivity in~     middle-aged individuals with different levels of body fat. The ultimate goal of this research~     is to develop an early diagnostic tool for Alzheimer's disease.~   "
136712|NCT01777776|"~     To evaluate the safety, tolerability and efficacy of LEE011 and LGX818 when administered~     orally to patients with BRAF mutant melanoma.~   "
136713|NCT01777763|"~     The purpose of this study is to collect pharmacokinetic (PK) information related to how well~     posaconazole tablet is distributed in the body and to determine the safety of this new~     formulation. The study consists of a Phase 1B study that includes participants with~     neutropenia undergoing chemotherapy for acute myelogenous leukemia (AML) or myelodysplasia~     (MDS) and a Phase 3 study that includes participants who are undergoing chemotherapy for AML~     or MDS and participants who are recipients of allogeneic hematopoietic stem cell transplant~     (HSCT).~   "
136714|NCT01777750|"~     The primary goal in the treatment of acute myocardial infarction is to reperfuse the ischemic~     myocardium to reduce infarct size. Animal data and human data suggest that whole-body cooling~     to temperatures below 35°C before revascularisation can additionally reduce infarct size and~     therefore improves outcome in these patients.~      The purpose of the study is to determine if a combined cooling strategy started in the~     out-of-hospital arena is able to reduce infarct size in acute myocardial infarction.~   "
136715|NCT01777737|"~     First study to test the validity of the treatment of idiopathic pulmonary fibrosis, which~     causes inflammation and fibrosis (scarring) of the lung tissue, with cotrimoxazole.~      Cotrimoxazole may improve the clinical course of the disease through eradication of~     Pneumocystis jiroveci colonization and other mechanisms as inhibiting the activation of~     alveolar macrophages and producing alterations in the surfactant system which favours the~     persistent activation of the inflammatory response and the development of pulmonary fibrosis.~   "
136716|NCT01777724|"~     The study will use a randomised controlled trial design to evaluate the effects of a combined~     intervention of Triple P-Positive Parenting Program Discussion Groups and Stress Control in~     comparison to a waitlist condition. The combined intervention will be evaluated with parents~     in Glasgow, United Kingdom, with a 3-8 year old child.~   "
136717|NCT01777711|"~     This study explores among couples in which both members are obese how the use of mental~     contrasting along with implementation intentions influence intentions and behavior related to~     weight loss (eating healthy and exercise), actual weight loss, as well as potential reasons~     (i.e., mediators) why these changes may occur (e.g., social support, changes in beliefs about~     weight loss, confidence in being able to eat healthy and diet).~   "
136718|NCT01777698|"~     Hepatocellular carcinoma represents 80-90% of primary hepatic malignant tumors. 80% of~     patients with hepatocellular carcinoma are associated with cirrhosis.~      Chemoembolization is a process in which a chemotherapeutic agent is deposited directly into~     the hepatic tumor where the principal artery is embolized.~      Bioelectrical impedance bases its evaluation in a model where the body is conformed by two~     different compartments: fat mass and fat free mass.~      Bioelectrical impedance is complemented by vectorial analysis, which is independent to the~     state of hydration and is helpful to monitor any changes in corporal composition. It can be~     used as a control for the interpretation of the bioelectrical impedance.~   "
136719|NCT01777685|"~     The present study was adopted to evaluate the pharmacokinetics of sulpiride after oral~     administration.~   "
136720|NCT01777672|"~     Oropharyngeal dysphagia (OD) is a major complaint among many patients with stroke and causes~     severe complications. There is no specific treatment for these patients. Impaired swallow~     response is caused by a delay in the timing of oropharyngeal reconfiguration with delayed~     airway protection. Swallow response is initiated by sensory afferent fibers in the oropharynx~     and cerebral cortex reaching the central swallowing pattern generator (CPG) in the medulla~     oblongata and brainstem motor nuclei. Hypothesis: Stimulation of pharyngeal sensory afferent~     fibers through TRPV1 receptors and electrical stimuli might enhance the stimulation of the~     CPG and speed the swallow response. Long-term treatment of OD will improve clinical outcome~     of stroke patients. Aim: To assess the effect of TRPV1 agonists (capsaicin) and that of~     sensorial pharyngeal electrical stimulation (intrapharyngeal and transcutaneous) on VFS signs~     and swallow response at 3, 6 and 12 months after treatment in stroke patients with~     established OD. To compare the clinical effect of classical rehabilitation strategies with~     that of these new afferent sensorial neurostimulation strategies in terms of nutritional~     status parameters, incidence of aspiration pneumonia and/or low respiratory tract infection,~     quality of life, and mortality. Methods: Clinical screening of OD with the volume-viscosity~     swallow test and assessment by VFS and quantitative measurements of swallow response.~     Randomized controlled trial assessing the effect of standard rehabilitation with that of~     afferent sensorial neurostimulation strategies.~   "
136721|NCT01777659|"~     The investigators will test the hypothesis that transcutaneous electrical nerve stimulation~     (TENS) may attenuate peripheral vasoconstriction and to improve blood flow redistribution~     during handgrip exercise in acute myocardial infarction (AMI) patients after Coronary~     Arterial Bypass Graft Surgery (CABG).~   "
136722|NCT01777646|"~     The study will evaluate the safety, tolerability and therapeutic effects of transplantation~     of escalating doses of autologous cultured mesenchymal bone marrow stromal cells secreting~     neurotrophic factors (MSC-NTF), in patients with amyotrophic lateral sclerosis (ALS).~   "
136736|NCT01777464|"~     In order to evaluate the effects a nasal provocation on the activation of different brain~     regions, the investigators want to set up a clinical trial investigating the short-term~     effects of a nasal histamine provocation in healthy volunteers and allergic patients while in~     supine position under the functional MRI device in order to visualize different brain~     regions.~   "
136723|NCT01777633|"~     Although DIPG is not curable, re-irradiation with a modest total dose and short treatment~     time provides good palliation of symptoms, improves quality of life, delays disease~     progression and has minimal and manageable toxicity.~      Treatment plan:~      At progression, full radiological and clinical documentation necessary including a~     neurological exam by a neurologist will be done. Progressive patients will be referred to~     radiotherapy.~      Radiation guidelines:~      30.6 Gray (Gy) will be applied in 1.8 to 2Gy fractions in conformal radiation to tumor bed.~     Radiation will be done in standard accelerators and according to standard guidelines used in~     treatment for all brain tumor patients.~   "
136724|NCT01777620|"~     This is a safety and efficacy study of BOTOX® in subjects with facial rhytides (glabellar~     lines and crow's feet lines).~   "
136725|NCT01777607|"~     The use of Impella RP is safe, feasible and provides a hemodynamic benefit in patients with~     right ventricular failure.~   "
136726|NCT01777594|"~     Hepatocellular carcinoma (HCC) is the fifth most common type of cancer worldwide and the~     third most common cause of death from cancer. Sorafenib is the only approved therapy for~     treatment of advanced HCC, and there is a need to identify more drugs that are beneficial for~     these patients without unacceptable side effects. Prodrug chemotherapy is an approach in~     which an inactive non-toxic agent is administered to the patient and gets activated within~     the body at specific locations, resulting in a higher concentration of the cytotoxic form at~     a tumor location while avoiding general side effects. G-202 (mipsagargin) is an example of~     prodrug chemotherapy. It is activated by Prostate Specific Memory Antigen (PSMA), which is~     expressed by some cancer cells and in the blood vessels of most solid tumors, but not by~     normal cells or blood vessels in normal tissue. It is believed that activation of the prodrug~     G-202 will allow the drug to kill cancer cells. This study will evaluate the activity and~     safety of G-202 in patients with hepatocellular carcinoma who have progressed after taking~     sorafenib. The study will evaluate clinical activity and safety of G-202 administered by~     intravenous infusion on three consecutive days of a 28-day cycle.~   "
136727|NCT01777581|"~     This study investigates whether milnacipran reduces radicular pain (sciatica) in patients~     with lumbosacral disc disease.~   "
136728|NCT01777568|"~     Our primary objective is to develop a clinical pathway for care of patients having colorectal~     surgery at the Clinic. In particular, the investigators would like to determine what~     intraoperative concentration of oxygen is optimal in our patients.~   "
136729|NCT01777555|"~     This randomized, multicenter, placebo-controlled, double-blind study will evaluate the~     efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing~     motor response fluctuations (OFF phenomena) as an outpatient (i.e., at home) and in the~     clinic.~   "
136730|NCT01777542|"~     Investigators are recruiting children for a clinical trial using the medication recombinant~     human IGF-1 (a.k.a. mecasermin or INCRELEX) to see if it improves the health of children with~     Rett syndrome (RTT). While IGF-1 is approved by the Food & Drug Administration (FDA) for~     certain use in children, it is considered an investigational drug in this trial because it~     has not previously been used to treat RTT. Information from this study will help determine if~     IGF-1 effectively treats RTT but will not necessarily lead to FDA approval of IGF-1 as a~     treatment for RTT.~   "
136731|NCT01777529|"~     Whether the lower immunogenicity of the mumps component obtained in clinical studies with the~     MMR in Brazil, due to the multidose presentation. Investigations were made on factors that~     could interfere with immunogenicity of mumps component, as the kits used for the immunoassay~     method, and potency of the vaccine, but no explanation was found. This study aimed to~     investigate the hypothesis that the lower immunogenicity of the mumps component of the MMR~     Bio-Manguinhos vaccine, is due to the multidose presentation.~      The Main objetctive is evaluate the immunogenicity of MMR after one dose in children 12 to 23~     months of life, comparing the performances multidose vial (10 doses per vial of vaccine~     produced in Bio-Manguinhos/Fiocruz through technology transfer from GlaxoSmithKline~     Laboratory - GSK) and single dose vial (1 dose per vial of vaccine produced by GSK).~   "
136732|NCT01777516|"~     This is a in-vitro study to evaluate the pharmacodynamic interaction between ticagrelor and~     its active metabolite (AR-C124910XX) and their effects on the pharmacodynamics of salicylic~     acid. The study consist of two parts of in-vitro study as follows;~        -  Part 1 : in-vitro study to evaluate the pharmacodynamic interaction between ticagrelor~          and its active metabolite.~        -  Part 2 : in vitro study to evaluate the pharmacodynamic interaction between ticagrelor~          and its active metabolite and their effect on the pharmacodynamics of salicylic acid on~          platelet aggregation tests with the agonist of arachidonic acid.~   "
136733|NCT01777503|"~     The objective of this study is to compare reduced-dose prasugrel and standard dose~     clopidogrel in patients older than 74 years with ACS, including non-ST-elevation (NSTEACS)~     and ST-elevation (STEMI) patients, undergoing early PCI. The primary endpoint of the trial~     will be the one-year composite of (all-cause)death, myocardial infarction, stroke and~     re-hospitalization due to cardiovascular reasons or bleeding.~   "
136734|NCT01777490|"~     The purpose of this study is to evaluate a caregiver skill training program (HI-FIVES),~     offered as a part of a randomized control trial to caregivers of Veterans referred to home~     and community-based long-term care. Of primary interest is to examine whether participating~     in HI-FIVES leads to clinically significant increases in days spent at home for Veterans~     compared to caregivers in usual care. The investigators aim, through the training, to~     decrease the number of days over 12 months post-intervention that Veterans spend in the~     emergency department, hospital, or nursing home. Days spent in these settings reduces the~     Veteran's quality of life and increases health care costs to the VA. The investigators also~     will evaluate whether caregivers in HI-FIVES have clinically significant reductions in~     depressive symptoms post-intervention compared to caregivers in usual care.~   "
136735|NCT01777477|"~     The purpose of this study is to evaluate the safety by defining the maximum tolerated dose~     (MTD) of Choloroquine when combined with Gemcitabine, and to evaluate preliminary efficacy of~     combined systemic Gemcitabine and Chloroquine. In addition, the influence of the treatment on~     the anti-cancer immunity and the value of GOLPH2 as serum marker for pancreatic cancer will~     be assessed within a translational objective.~        -  Trial with medicinal product~   "
136737|NCT01777451|"~     Whole body MRI will be performed in patients with neurofibromatosis Type 1~      PURPOSE 1:~      To determine the total tumor load (neurofibroma) and to diagnose plexiform neurofibromas or~     malignant peripheral nerve sheath tumors. All patients will be scanned two years after the~     baseline whole body MRI to investigate to investigate the changes of total tumor load.~      PURPOSE 2: added value of diffusion weighted imaging in diagnosis of high-risk neurofibromas~      PURPOSE 3 : to determine the apparent diffusion coefficient of the malignant nerve sheath~     tumors and neurofibroma.~      PURPOSE 4 : correlation between histopathology of the surgically resected~     neurofibroma/malignant nerve sheath tumors and MRI findings~   "
136738|NCT01777438|"~     Allergic rhinitis (AR) is defined as inflammation of the nasal mucosa after exposition to an~     allergen in sensitized patients. AR causes not only nasal symptoms such as sneezing, itchy~     nose, rhinorrhea and nasal obstruction, but also has a significant impact on quality of life.~     Symptom control and overall satisfaction in patients undergoing subcutaneous immunotherapy~     (SCIT) or sublingual immunotherapy (SLIT) on the long term has not yet been investigated so~     far.~   "
136739|NCT01777425|"~     State-of-the-art documents like ARIA and european position paper on rhinosinusitis (EPOS)~     provide clinicians with evidence-based treatment algorithms for allergic rhinitis (AR) and~     chronic rhinosinusitis (CRS) respectively (1)(2) . The currently available medications can~     alleviate symptoms associated with AR and RS, and most patients with RS benefit from~     endoscopic sinus surgery (ESS). In real life, a significant percentage of patients with AR~     and CRS continue to experience bothersome symptoms despite adequate treatment. This group~     with so-called severe chronic upper airway disease (SCUAD) represents a therapeutic challenge~     (3).~   "
136740|NCT01777412|"~     This is a phase 1b interventional trial of bevacizumab (Avastin®) to evaluate the~     tolerability/safety and preliminary efficacy of bevacizumab (Avastin®) as add-on therapy for~     treatment of acute optic neuritis and/or transverse myelitis in neuromyelitis optica (NMO)~     and neuromyelitis optica spectrum disorder (NMOSD). A single infusion of Avastin® is added to~     standard-of-care high dose steroids and an additional dose of Avastin® is added to plasma~     exchange (if necessary). The primary outcomes are clinical changes in the Expanded Disability~     Severity Scale, Timed 25-foot Walk and Low Contrast Visual Acuity, MRI parameters and safety.~   "
136741|NCT01777386|"~     Tissue expansion methods have been recommended as a means of improving the clinical results~     with perforator flaps but in plastic surgery literature there are few clinical trials~     supporting this opinion. The purposes of this clinical study are to address the ''preexpanded~     perforator flap concept'' by demonstrating a case series of relevant reconstructive~     procedures and to evaluate the perforator vessel changes that happen during the expansion~     periods of various perforator flap donor sites.~   "
136742|NCT01777373|"~     The purpose of this study is to determine whether extension of the conducting airways into~     the distal lung, or bronchiolization, occurs early in the course of Idiopathic Pulmonary~     Fibrosis, a disease wherein normal lung structures are destroyed and replaced by~     non-functional scar tissue.~   "
136743|NCT01777360|"~     To determine, from patients presenting severe asthma and an increase in bronchial smooth~     muscle mass, those who would be the best candidates for bronchial THERMOPLASTY. THERMOPLASTY~     should improve control of the asthma, reduce day-to-day symptoms and severe exacerbations,~     and improve respiratory function~   "
136744|NCT01777347|"~     The purpose of this study is to determine whether nebulized hypertonic saline solution~     reduces the admission rate 48 hours after initial treatment in the emergency department, when~     compared to normal saline solution (control).~   "
136745|NCT01777334|"~     The purpose of this 24 week study is to evaluate the spirometric lung function effect (trough~     FEV1) of Umeclidinium/Vilanterol 62.5/25 once daily compared to Tiotropium 18 mcg once daily~     along with safety assessments in subjects with COPD.~   "
136746|NCT01777321|"~     The purpose of this study is to assess the immunogenicity, safety, and reactogenicity of GSK~     Biologicals' Herpes Zoster (HZ) vaccine (GSK 1437173A) when administered subcutaneously (SC)~     as compared to intramuscularly (IM) to people 50 years of age and older.~   "
136747|NCT01777308|"~     The purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of a~     booster dose of GSK Biologicals' MenACWY-TT vaccine administered at 6 years post-primary~     vaccination with either GSK Biologicals' Hib-MenC-TT vaccine (Menitorix™) or Hiberix™ and~     Meningitec™, in healthy subjects aged 12-18 months at primary vaccination and to evaluate the~     long-term antibody persistence at 2 years after MenACWY-TT booster vaccination.~      This is an extension study of the Hib-MenC-TT-016 study (NCT number: NCT00326118).~   "
136748|NCT01777295|"~     This study aims to develop innovative immunological read-outs and new technologies in order~     to further characterise the early immune response and its kinetics as well as the adaptive~     immune responses to adjuvanted vaccines.~      This study will also evaluate the reactogenicity in healthy, hepatitis B virus naive adults~     vaccinated with the hepatitis B surface antigen in combination with a GSK Biologicals'~     Adjuvant System.~   "
136749|NCT01777282|"~     This study is designed to examine the long term safety and efficacy of weekly subcutaneously~     injected albiglutide in combination with a single oral antidiabetic drug for 52 weeks in~     Japanese subjects with type 2 diabetes mellitus.~   "
136750|NCT01777269|"~     This is an European double-blind, placebo controlled parallel group comparison of DUODART~     (fixed dose combination of dutasteride 0.5mg and tamsulosin 0.4mg, one capsule daily) and~     placebo.~      PRIMARY OBJECTIVE:~      To assess the change in sexual function from baseline to 1 year in sexually active men with~     at least moderate BPH who are treated with DUODART, compared to men treated with placebo .~   "
136761|NCT01777126|"~     After radical cystectomy, postoperative ileus (POI) is a common complication resulting in a~     delayed oral nutritional intake with prolonged recovery and hospital stay. However, it is~     questionable if nutritional support by routine use of parenteral nutrition (PN) is~     justifiable.~      A non-randomized before-after trial was conducted. Patients treated with an elective regular~     radical cystectomy and without preoperative contra-indications for enteral nutrition were~     eligible. In the control group, PN was initiated immediately after the procedure and~     continued until resumption of diet. In the interventional group, an ONP was implemented. PN~     could be initiated if oral intake was still insufficient after five days. The primary end~     point was the postoperative length of stay.~   "
136751|NCT01777256|"~     This is an adaptive, dose ranging, Phase II study to investigate the relationship between~     repeat doses of GSK2586184 and the pharmacodynamic effect and clinical efficacy in patients~     with active systemic lupus erythematosus (SLE). This study will also investigate the safety~     and tolerability of repeat doses of GSK2586184. During the study, up to 3 Interim Analyses~     will be conducted. These are to monitor the pharmacodynamic effect and safety following 2~     weeks of therapy (Interim Analysis 1); and the clinical efficacy and safety of GSK2586184~     following 12 weeks of therapy (Interim Analyses 2 and 3). Subjects who meet the entry~     criteria (approximately 150 to 250) will be randomized in a 1:1:1:1:1 ratio to receive~     GSK2586184 at doses of 50 milligram (mg) twice daily (b.i.d), 100 mg b.i.d, 200 mg b.i.d, 400~     mg b.i.d or Placebo b.i.d. GSK2586184 tablets available in 50 and 200 mg dose strength will~     be administered orally up to 12 weeks.~      Subjects who complete the study will participate in the study for approximately 21 weeks.~   "
136752|NCT01777243|"~     The study will be conducted in two parts. The first (Part A) will be an open label single~     dose escalation part beginning with the proposed starting dose level of GSK2398852 as 5~     milligram (mg) [approximately equivalent to 0.1 mg/kilogram (kg)]. The next escalation dose~     levels are proposed as 1 mg/kg, 3 mg/kg, 10 mg/kg and 30 mg/kg. GSK2315698 will be~     administered at variable doses until the concentration of the serum amyloid P component~     monoclonal antibody (SAP mAb) has fallen below 100 nanogram/millilitre (ng/mL). Decisions~     about these next dose levels will be made following safety review of the prior subjects'~     data; dose levels may be changed (increased and lowered) and dose levels may be repeated~     depending on the observed safety such that Part A extension study may be performed. In~     addition, pharmacokinetics of GSK2315698 (SAP depleter) and GSK2398852 (anti-SAP mAb), and~     circulating SAP concentrations will be assessed. Dose escalation in Part A will continue to~     the highest well tolerated dose or the highest allowable dose. Subjects will be closely~     monitored and will undergo Equilibrium contrast Magnetic Resonance Imaging (EqMRI) including~     organ volume, Elastography and Liver Biopsy if required.~      Part B will be a randomized partially blinded part with the principal objective of assessing~     the dose response of the GSK2398852 in more detail. Subjects will be assigned to one of~     approximately 5 dose groups from Part A. The precise selection of numbers of subjects and~     dose levels will be informed by the results from Part A.~   "
136753|NCT01777230|"~     Objective of the study: To study the concordance of sentinel node (SN) localization between~     preoperative Magnetic Resonance Lymphangiography and SPECT-CT SN mapping and the~     intra-operative SN procedure for low stage cervical cancer.~      Background: The SN procedure for surgically treated cervical cancer is promising.~     Unfortunately, efficient and direct intra-operative SN localisation, without an extensive~     surgical exploration, remains a challenge even with combined use of patent blue dye en~     technetium-99m (99mTc). Preoperative imaging (= mapping) with 99mTc based SPECT-CT, which is~     increasingly adopted, has partly alleviated this problem. The investigators aim to~     investigate the feasibility of a new SN mapping modality, which visualises the (sentinel)~     lymph nodes using a Magnetic Resonance Imaging (MRI) technique (so called; Magnetic Resonance~     Lymphangiography), and compare it to SPECT-CT.~      Design: Prospective, feasibility type diagnostic study. 40 subjects targeted. Via vaginal~     speculum exam, a specific MRI contrast-agent will be intracervically injected. Subsequently,~     on a wide bore 1.5T MRI system multiplanar imaging is performed, followed by a blinded review~     (experienced radiologist) for bilateral SN localization. Standard care with a preoperative~     SPECT-CT (after intracervical 99mTc administration). A blinded nuclear medicine specialist~     will localize the SN on the SPECT-CT images. Open or (robot-assisted) laparoscopy performed~     for localization of the blue stained and/or 99mTc-hot SN. Excision of the SN with freeze~     sectioning and histological review. Statistical analysis with intrapatient testing for~     concordance of MR Lympangiography and SPECT-CT based SN localization against the reference~     standard: the intra-operative sentinel node procedure.~   "
136754|NCT01777217|"~     The purpose of this study is to determine if Vesicare (Solifenacin succinate) is effective in~     treating over-active bladder symptoms during radiation therapy of the prostate.~   "
136755|NCT01777204|"~     Gastrointestinal (GI) complications after renal transplantation are commonly reported as side~     effects of immunosuppressive agents. Despite this, motility disorders have been scantily~     studied. Alternating Current Biosusceptometry (ACB) are biomagnetic sensors designed for a~     wide range of applications. In clinical practice, their non-invasive and radiation free~     features provide an excellent approach for monitoring of GI transit as alternative to~     scintigraphy and breath tests. The aim of this study is to examine GI transit and motility of~     solids in stable renal transplant recipients to determine the potential influence of~     immunosuppressive therapy on gastrointestinal parameters.~   "
136756|NCT01777191|"~     The purpose of this study is to evaluate the serum concentration of ixekizumab after~     administration using either prefilled syringe or auto-injector in participants with moderate~     to severe plaque psoriasis. Treatment period is followed by 40 weeks optional safety~     extension.~   "
136757|NCT01777178|"~     This study will compare acid-base changes during hemodialysis treatments with a standard~     dialysis bath versus a lower bicarbonate dialysis bath, and aims to define the factors that~     limit equilibration of the bicarbonate concentration in a patient's blood with that in the~     dialysate.~   "
136758|NCT01777165|"~     This study will evaluate the safety and efficacy of ABT-719 in preventing acute kidney injury~     in patients undergoing high risk cardiac surgery.~   "
136759|NCT01777152|"~     This is a double-blind, randomized, multicenter, phase 3 clinical trial to compare the~     efficacy and safety of brentuximab vedotin in combination with CHP with the standard-of-care~     CHOP in patients with CD30-positive mature T-cell lymphomas.~   "
136760|NCT01777139|"~     This is a multicentre, long-term, open-label extension (OLE) study to assess the long-term~     safety, tolerability and efficacy of retigabine immediate-release (IR) as adjunctive therapy~     in adult Asian subjects with drug-resistant partial-onset seizures (POS).~   "
136803|NCT01776580|"~     Women with pelvic organ prolapse often accompany with urinary symptoms or sexual dysfunction,~     and analyzing the association will be helpful to identify the indication of proper~     management. Therefore, the aim of this study is to identify the above associations by~     perineal sonography.~   "
139938|NCT01735682|"~     It is hypothesized that whole body vibration exercise group will have significantly more~     improvement in physical functioning and reduction in fall incidence among institutionalized~     elderly, compared with conventional exercise group and control group.~   "
136762|NCT01777113|"~     Stroke is a global health-care problem that is common, serious and disabling. In most~     countries, stroke is second or third most common cause of death and one of the main causes of~     acquired adult disability. After stroke, patients remain at continued high risk for recurrent~     stroke as well as for myocardial infarction and cardiac death. After completion of~     conventional physical therapy, there are no empiric recommendations and few resources~     promoting regular exercise during the chronic stroke period.Interventions to improve~     cardiorespiratory fitness are still not part of routine neurorehabilitation programs in many~     rehabilitation centers, and therapy is often dominated by standard rehabilitative therapies~     based on neurodevelopmental principles such as the Bobath concept. These standard therapies~     are an insufficient stimulus to increase fitness levels after stroke.~   "
136763|NCT01777100|"~     The appropriate management of postoperative pain is recognized as an important clinical~     challenge with implications beyond humanitarian issues. Evidence shows that effective~     postoperative analgesia is associated with physiological benefits to the patient, shortened~     length of hospital stay and lower rates of in-hospital complications, such as pneumonia,~     delirium and persistent pain after surgery. However, despite the availability of several~     analgesic drugs and strategies the prevention and treatment of postoperative pain is often~     suboptimal. Remifentanil is a potent short acting opioid commonly used in continuous infusion~     for anesthesia for several surgical procedures. Remifentanil has been extensively advocated~     as a means to provide quick patient awakening in the immediate postoperative period with a~     very low risk of respiratory depression. Yet it does not provide residual analgesia and~     postoperative pain is a major concern. In order to overcome this limitation, practicing~     anesthesiologists frequently give patients a single dose of Sufentanil, a long acting opioid,~     during the induction of anesthesia where Remifentanil will be used in continuous infusion.~     However the effectiveness of this strategy still lacks evidence from controlled clinical~     trials.~   "
136764|NCT01777087|"~     This study has two purposes: first, to locate and identify the brain activation (the areas~     of the brain) which respond to pain; and second, to look at how brain activation is~     influenced by a person's genetics (the traits they inherited from their parents). A Magnetic~     Resonance Imaging (MRI) scanner will be used to gather pictures of the brain (similar to an~     x-ray, but based on different scientific principles) that will be used to determine which~     areas are active. The hypothesis is that the variation in brain activity between people can~     be partially explained by genetic differences. This study consists of an two pain tasks~     applied during a one time visit to the MRI suite. There are no followup visits.~   "
136765|NCT01777074|"~     The present study is conducted in order to assess the acceptability of Hepatitis B~     vaccination in French general practitioners and peadiatricians before and after reimbursement~     of the paediatric vaccine InfanrixHexa. Two data measurement time points are planned, first~     before reimbursement and after reimbursement.~   "
136766|NCT01777061|"~     When evaluating prostate cancer patients for recurrent disease, computed tomography (CT), and~     magnetic resonance imaging (MRI) are both highly sensitive methods for detecting lymph nodes,~     but are not specific as to whether the lymph nodes are malignant or benign.~      While positron emission tomography (PET) utilizing radioactive glucose (FDG) has~     revolutionized staging, restaging, and monitoring response to therapy in many prevalent~     cancers such as breast, colorectal, esophageal, head and neck, lung, lymphoma, and melanoma,~     findings with prostate cancer have proven less sensitive because prostate cancer has a lower~     avidity for glucose. A newer PET isotope, utilizing acetate that is incorporated into the~     cell membrane of rapidly proliferating cells, has shown greater sensitivity than FDG in~     detecting prostate cancer.~      This study will assess the clinical effectiveness of utilizing [11C]Acetate PET scans in~     identifying recurrent prostate cancer.~   "
136767|NCT01777048|"~     The overarching aim of the proposed study is to assess whether omega-3 fatty acids~     supplementation can augment the effects of methylphenidate in children with ADHD. The~     investigators hypothesized that omega-3 fatty acids supplementation will be associated with~     improved ADHD symptoms.~   "
136768|NCT01777035|"~     To study all ICU patients with an independent baseline functional status , who experience a~     critical illness requiring intubation and mechanical ventilation evaluating long-term~     cognitive and executive function and long term cost effectiveness in survivors who required~     mechanical ventilation.~   "
136769|NCT01777022|"~     Rates of stillbirth in Scotland are among the highest in resource rich countries. The~     majority of stillbirths occur in normally formed infants, with (retrospective) evidence of~     placental insufficiency being the commonest clinical finding. Maternal perception of~     decreased fetal movements appears to be an early biomarker both of placental insufficiency~     and subsequent stillbirth.~      The study proposed here will test the hypothesis that rates of stillbirth will be reduced by~     introduction of a package of care consisting of strategies for increasing pregnant women's~     awareness of the need for prompt reporting of decreased fetal movements, followed by a~     management plan for identification of placental insufficiency with timely delivery in~     confirmed cases. The odds of stillbirth fell by 30% after the introduction of a similar~     package of care in Norway but the efficacy of this intervention (and possible adverse effects~     and implications for service delivery) have not been tested in a randomized trial.~      The investigators plan a stepped wedge cluster design trial, in which hospitals in Scotland~     and Ireland will be randomized to the timing of introduction of the care package. Outcomes~     (including the primary outcome of stillbirth) will be derived from Scotland and Ireland's~     detailed routinely collected maternity data, allowing the investigators to robustly test the~     hypothesis. A nested qualitative study will examine the acceptability of the intervention to~     patients and health care providers and identify process issues (barriers to implementation).~   "
136770|NCT01777009|"~     Short and long term outcomes of total knee arthroplasty patients surgically exposed with~     patellar eversion are compared to those patients exposed by laterally retracting the patella.~     It was hypothesized that there would be no difference.~   "
136771|NCT01776996|"~     This is an open-label protocol designed to provide continued access to maraviroc to only~     those subjects who have completed previous studies of maraviroc and continue to receive~     clinical benefit.~   "
136772|NCT01776983|"~     Determination of collagen, pigment and haemoglobin content of sun exposed and sun protected~     skin by Siascopy. Immunocompromised patients (for more than seven years) compared to~     immunocompetent patients.~        -  Trial in the field of transplantation / xenotransplantation~   "
136773|NCT01776970|"~     The clinical primary hypothesis is that there will be a difference between a Cannabis Sativa~     extract and placebo in their effect on spasticity in Motor Neuron Disease (MND) patients with~     signs of involvement of the upper motor neuron (UMN) resulting in disabling spasticity.~      Secondary goals of the study are to evidence of improvement in other symptoms (in particular~     pain), and to show favourable trends on functionality measures. Finally, cannabis based drug~     safety and tolerability will be studied through vital parameters (including weight and~     pulmonary function) measurement, and analyzing ALS function rating scale progression slope~     hopefully, showing a slowing of the functional values decrease, owing to cannabis~     neuroprotective effects)~   "
136774|NCT01776957|"~     The rate of repeat abortions will be lowest in those women who choose immediate insertion of~     an IUD post-abortion versus those who immediately choose oral contraceptive pills and those~     who indicate all other contraceptive choices including no contraception The provision by the~     health system of IUDs for immediate insertion will result in the lowest health system costs.~   "
136775|NCT01776944|"~     High prevalence of obesity in children has increased associated complications such as type 2~     diabetes, hypertension and fatty liver disease. Dietitians develop a meal plan that restricts~     caloric intake by estimating the resting and total daily energy expenditures.Estimation of~     energy needs is most commonly done using predictive equations. Reliable and valid energy~     requirements can be obtained using a traditional metabolic system, however this is an~     expensive option. Handheld indirect calorimeters may be a good alternative to measure energy~     needs. Several studies have been conducted to determine the validity and accuracy of handheld~     calorimeters in adults and health children, however, to the best of our knowledge, there are~     no such studies in the overweight and obese pediatric population.~      The purpose of this study is to validate a handheld indirect calorimeter against a~     traditional metabolic system in overweight and obese children.~      If handheld calorimeters can accurately measure resting energy expenditure in overweight and~     obese adolescents, dietitians will have an opportunity to tailor pediatric weight management~     interventions based on parameters that are unique to each individual.~   "
136776|NCT01776931|"~     Amino acids are building blocks of protein in our body. It is important that pregnant women~     eat adequate amount of protein/amino acids to ensure healthy growth and development of the~     fetus.Lysine is an amino acid that is present in high amounts only in animal foods (meat) and~     not much in plant foods such as wheat. Currently , it is not known how much lysine is needed~     to eat during pregnancy.~      Current Dietary Reference Intake recommendations for amino acid requirements are based on~     non-pregnant adults, and minimally based on pregnancy-specific data.To the investigators~     knowledge, there is no scientific information regarding the amount of lysine needed at~     different stages of pregnancy.~      The investigators hypothesize that current recommendations for lysine intake in pregnant~     women are underestimated. The investigators also hypothesize that the lysine requirements~     will be greater during the later stages of pregnancy, compared to early stages.~      The purpose of this study is to determine lysine requirements in healthy pregnant women~     19-40y,(1st and 3rd trimester) using a modern, safe and quick technique called the indicator~     amino acid oxidation technique and to compare lysine requirements during early (15-18 weeks~     last menstrual period) late (33-36 weeks last menstrual period) stages of pregnancy.~   "
136777|NCT01776918|"~     Metabolic diseases and mitochondrial disorders are caused by genetic mutation which lead to~     disruptions in energy producing pathways in our body. Enough energy or calories must be given~     in the diet to ensure normal growth and development. Currently, energy needs for patients~     with metabolic and mitochondrial diseases are not measured, but is estimated using a~     mathematical equation based on healthy children. This may lead to under feeding or~     overfeeding of calories, and has negative nutritional implications.~      The clinical standard for measuring energy needs is the use of indirect calorimeter.The~     indirect calorimeter takes individualized measurements for each patient and therefore will~     enable dietitians and clinicians to provide sufficient calories in the diet to better manage~     the disease and promote normal growth and development.~      We believe daily energy requirements will vary within metabolic diseases (Phenylketonuria)~     and mitochondrial disorders (mitochondrial fatty acid oxidation defect, POLG1 mutation etc.).~      The objective of this preliminary study is to measure resting energy expenditure in children~     living with metabolic and mitochondrial conditions and data obtained will be used to generate~     future hypothesis and will form a basis for future studies.~   "
136778|NCT01776905|"~     The objective of this clinical trial is to determine whether a Photoacoustic flow cytometry~     (PAFC)-based prototype device can detect circulating tumor cells (CTCs) in the blood of~     melanoma patients in vivo, in real time, and do so at detection limits at least one order of~     magnitude below the detection limits of currently existing ex vivo methods.~   "
136779|NCT01776892|"~     Dupuytren's disease results in deformity of the hand and this can lead to trouble with daily~     activities. Treatment traditionally involves cutting out diseased tissue, however this can~     cause damage to important structures in the hand and results in large scars.~      Needle aponeurotomy and collagenase injections are newer treatments that are thought to be~     safer. These treatments allow quicker return to function. One drawback is that Dupuytren's~     deformity may return more quickly than when all diseased tissue is surgically cut out.~      This research study is designed to compare the effectiveness of needle aponeurotomy and~     collagenase injection for Dupuytren's disease. This study will determine which procedure~     gives the best results- either needle aponeurotomy, collagenase injection, or both procedures~     in combination. Participants will be evaluated to see how they do in the long term.~   "
136780|NCT01776879|"~     This study will examine speech intelligibility of early parkinson's disease (PD) patients,~     early PD patients and first degree relatives. The investigators hypothesis that advanced PD~     patients will present decreased speech intelligibility more than early PD patients. Speech~     intelligibility of first degree relatives will be normal.~   "
136781|NCT01776866|"~     The investigators hypothesized that dual-axis rotational coronary angiography was~     non-inferior to standard coronary angiography with respect to diagnosis of coronary artery~     disease.~   "
137003|NCT01773980|"~     The goal of this project is to develop and pilot test an innovative approach for overcoming~     barriers to cancer screening among women with physical disabilities (WWD) in rural Oregon.~     Many studies have shown that people with disabilities receive fewer indicated cancer~     screening services and are more likely to have poor cancer-related outcomes, such as late~     stage at diagnosis, compared to those without disabilities.~   "
136782|NCT01776853|"~     The purpose of the study is to investigate if patients with Irritable Bowel Syndrome (IBS)~     who also report bloating are more likely to report clinically important gastrointestinal~     symptoms after consuming fructose or fructans than after consuming glucose. We will also use~     MRI imaging to investigate the mechanisms by which those symptoms might be caused.~      We will also study a parallel group of age and gender frequency matched healthy volunteers to~     provide descriptive statistics on a likely reference range for the healthy population.~      Irritable Bowel Syndrome (IBS) is a common chronic condition, the main features of which are~     pain in the abdomen, an erratic bowel habit and sometimes bloating. Recent research has found~     that certain carbohydrates (sugars) in the diet can cause symptoms such as discomfort,~     bloating and wind/gas in people with IBS. These sugars are not well digested in the small~     bowel. They move to the colon (large bowel) where bacteria act on them by fermentation,~     producing gas. Some of the gas is absorbed and breathed out through the lungs, where we can~     measure it. The rest is released as flatulence/ wind, or occasionally belching. People~     without IBS rarely get symptoms after consuming these sugars. We want to find out what is~     different in IBS sufferers.~      We will study fructose and fructans, sugars found in fruit, vegetables and wheat. Fructose~     draws water into the small bowel but fructans do not so we can compare effects on the small~     bowel and colon. Participants will attend three times, and on each occasion consume a drink~     containing either fructose, fructans, or glucose - a sugar that does not cause symptoms.~     Neither they nor the investigators present will know which drink is which. They will record~     their symptoms over the next 5 hours. We will observe how many report a clinically important~     increase in symptoms.~      To look at what is happening in the bowel we will use a technique called Magnetic Resonance~     Imaging (MRI). We want to see if more gas, or water, builds up in people with IBS than in~     healthy volunteers. We will also measure the amount of hydrogen released in the breath to see~     if this is could be a simple bedside test that agrees with the MRI findings~      Finding differences between the response of participants to fructose, fructans and glucose~     could change the way we advise patients, and could lead to the use of MRI as a test for IBS.~   "
136783|NCT01776840|"~     The purpose of this study is to evaluate the efficacy and safety of ibrutinib given in~     combination with bendamustine and rituximab in patients 65 years of age or older with newly~     diagnosed mantle cell lymphoma.~   "
136784|NCT01776827|"~     To study the long term outcome of Laparoscopic Hiatal Hernia Repair with human acellular~     dermal matrix Alloderm (LifeCell, Branchburg, NJ) mesh at a University Hospital.~   "
136785|NCT01776814|"~     Chronic hepatitis B virus infection is an important cause of morbidity and mortality.~     Tenofovir disoproxil fumarate and entecavir were licensed for the treatment of hepatitis B~     virus infection. In this study, the investigators will try to make comparison between~     Entecavir and Tenofovir and investigate the efficacy.~   "
136786|NCT01776801|"~     The purpose of this project is to determine during moderate rise of intracranial pressure~     (ICP) in awake patient, the change in autonomic function and its influence on cerebral and~     systemic haemodynamics.~   "
136787|NCT01776788|"~     The randomized, controlled trial is to investigate and evaluate the effects of short-term~     continuous subcutaneous insulin infusion (CSII) sequential exenatide therapy on β-cell~     function, long-term glycemic control and glycemic remission rate in newly diagnosed type 2~     diabetic patients.~   "
136788|NCT01776775|"~     Postoperative seroma formation is one of the most common complications after ventral hernia~     repair with mesh. Although some seromas may not have clinical impact postoperative seroma~     formation often causes pain and discomfort and may even compromise wound healing. Abdominal~     binders (also called trusses, girdle, ostomy belt, longuette or abdominal belt) (AB) are~     commonly used in abdominal and plastic surgery to prevent seroma formation and diminish pain~     and discomfort after operation. The primary aim of the present study is to investigate the~     effect of postoperative abdominal binders after laparoscopic incisional hernia repair on~     postoperative pain, discomfort and quality of life. Secondary, we register seroma formation.~     A randomized, controlled, investigator-blinded study supplemented with blinded statistical~     analysis. We include 60 (2x30) incisional hernia repairs. Patients are randomized either to~     abdominal binder or no abdominal binder (controls). The abdominal binder is worn from~     immediately after the operation and continuously for 7 days and nights. All patients have a~     standardized operation with standardized intra- and postoperative medication regimen.~     Endpoints measurements are clinically detectable seroma formation scored with seroma~     classification system buý S. Morales-Conde, pain scored with self-registrations with VAS, and~     quality of life scored with EQ-5D, recurrence and other complications are also registered.~     Patients are followed until 90 days after the operation.~   "
136789|NCT01776762|"~     Based on an established Follow-home-programme offered at discharge from hospital the aim of~     this study is to test a model of how nutritional intervention in elderly patients can be~     systematized and quality assured in the transition between sectors. Furthermore the aim is to~     demonstrate that this model has a positive effect on the functioning and well-being of the~     elderly patient.~      The purpose of the Follow-home-programme is to facilitate the transition of the elderly~     patient between hospital and private home in order to follow-up on any medical, nursing- or~     retraining-related intervention necessary to the rehabilitation of the patient. However this~     offer does not focus on nutrition in particular. This is a problem as many elderly patients~     are known to develop a poor nutritional status due to low appetite, disease etc. Our~     hypothesis is that adding a systematic nutritional focus to the Follow-home intervention~     programme will promote the rehabilitation of the elderly patient further.~      The nutritional intervention in our study will focus on improving energy- and protein intake~     and we will measure the effect on the patient's functional abilities, quality of life and~     rate of hospital readmissions. The intervention model will be based on individualized~     nutritional counselling by a registered dietician in the patients home.~   "
136790|NCT01776749|"~     Aim of the study Failed back surgery syndrome (FBSS) is a clinical entity consisting of~     chronic leg and /or back pain due to radicular nerve damage. The effectiveness of Spinal Cord~     Stimulation (SCS) in the pain management of patients with FBSS is proven. Patients mostly~     have dominant leg pain, however a significant percentage of FBSS patients has a more~     pronounced back pain and are commonly excluded from SCS as it is often inadequate in~     relieving both the back and leg pain components. Recently some reports showed the benefit of~     subcutaneous stimulation (SubQ) for low back pain in patients with FBSS. This has been~     confirmed by a feasibility study performed by our group. The aim of the randomized controlled~     study is to evaluate the effect of SubQ on low back pain in FBSS patients for whom SCS gives~     an inadequate back pain relief.~      Hypothesis We hypothesize that SubQ in addition to SCS in FBSS patients with leg and low back~     pain is more effective in treating low back pain (i.e. >50% pain reduction) than SCS alone.~   "
137004|NCT01773967|"~     The investigators will study the efficacy and side effect profile of LGG, a probiotic, in~     pediatric patients with acute gastroenteritis.~   "
137005|NCT01773954|"~     To evaluate the visual outcome and number of injections required during an optical coherence~     tomography (OCT)-guided treat and extend regimen with intravitreal aflibercept for treatment~     of subfoveal neovascular age-related macular degeneration (NVAMD).~   "
136791|NCT01776736|"~     For AIS, the caring of patients with spinal deformities has a long and varied history. Severe~     spinal deformities can greatly reduce pulmonary and cardiac functions, which may lead to~     death from cardiopulmonary failure. Therefore, surgery is generally suggested when the~     curvature of the spine is greater than 45-50 degrees. The adverse psychological impact of~     orthoses treatment on patients and its poor compliance has been a well-recognised problem.~     Some orthotic research studies indicate that early intervention of spinal deformities is~     particularly desirable. Taking into consideration current clinical practices, if the curve is~     less than 20 degrees, even if the child is at a high risk of progressive spinal deformity~     during the age of 10-16 at puberty, treatment is nothing more than just observation.~      This project aims to combine clinical experience with textile and materials sciences to~     research and develop a posture correction girdle for adolescents with early scoliosis. As a~     result, this will reduce the future likelihood of brace wear or surgery.~      In this study, the eligible subjects will be given tailor-made posture correction girdles to~     wear it 8 hours daily. Monitoring and observation will be provided during the six months~     girdling period. Data will be collected before and after the girdling by X-ray radiograph for~     analysis, in order to comparison the spine curvature condition. Locomotion of the subject~     with and without wearing the posture correction girdle will also be reference.~   "
136792|NCT01776723|"~     The purpose of this study is to find out if treating Chronic Myelomonocytic Leukemia (CMML)~     with a study drug [ruxolitinib] can improve outcomes of patients with CMML. The first step of~     the study is to learn the dose of ruxolitinib that is tolerable (bearable). It has already~     been studied in a number of patients with different bone marrow diseases and is approved for~     the treatment of a disease called Myelofibrosis; however, it is not approved for treatment of~     CMML. It is given orally (by mouth). Most people tolerate it well but the tolerability has~     not been determined in patients with CMML. We will be testing different doses to determine~     how much of the medication people can tolerate (bear) before they develop side effects.~   "
136793|NCT01776710|"~     A primary therapeutic goal for patients with intermittent claudication (IC) is to regain lost~     physical function through exercise rehabilitation. Supervised exercise programmes can~     markedly improve walking capacity, but these are resource intensive, National Health Service~     provision is limited, and patients cite accessing services as a barrier to participation.~      Increasing walking activity via a structured education programme might be a pragmatic~     solution for improving walking capacity, health and wellbeing in patients with IC; however,~     further research is needed to substantiate this. Hence, the aim of this project is to develop~     a pragmatic education programme to increase walking in these patients and to collect data on~     its feasibility to inform the development of a definitive trial investigating clinical and~     cost effectiveness.~      Focus groups will be conducted to inform the development of the education programme.~     Programme components will be theoretically-underpinned and evidence-based. The development of~     the programme will be an iterative process involving pilot work, feedback, evaluation, and~     revision. The programme will then be assessed in a randomised controlled pilot study with~     6-week follow-up (n=30). We will assess the feasibility of the intervention and obtain~     preliminary data of its impact on important outcomes (daily steps/physical activity, walking~     capacity, quality of life, illness perceptions).~   "
136794|NCT01776697|"~     A randomized, open-labeled, comparative 3-way crossover study to compare the pharmacokinetic~     characteristics and food effect of pelubiprofen (30mg) tablet IR TID and pelubiprofen SR (as~     a pelubiprofen 90 mg) tablet QD in healthy subjects.~   "
136795|NCT01776684|"~     To detect resistance gene from serially collected plasma DNA in non-small cell lung cancer~     harbouring EGFR activating mutation who are being treated with EGFR TKIs by using castPCR~     method.~   "
136796|NCT01776671|"~     Phantom limb pain (PLP) is a common disorder reported by the patients who undergo amputation.~     Even though the cause of PLP remains unclear, Gabapentin has been widely used. The purpose of~     this study is to evaluate the accuracy and efficacy achieved in using of extended release~     Gabapentin. Reducing the incidence of chronic post-amputation pain and improving clinical~     outcomes postoperatively.~   "
136797|NCT01776658|"~     The aim of this pilot study is to compare the analgesic effect of SYL1001 versus placebo in~     patients with ocular pain associated with Dry Eye Syndrome. General and local tolerability~     are also evaluated.~   "
136798|NCT01776645|"~     The purpose of this study is to determine whether compassion training will improve the~     physical and psychological well-being of patients with chronic pain. The investigators also~     want to determine whether any benefit of compassion training in the patients spreads to~     significant others with whom the patient has a close relationship.~   "
136799|NCT01776632|"~     The low prevalence of moderate-to-vigorous physical activity (MVPA) among adult Latinas~     likely contributes to the high rates of cancer and other chronic diseases in this population.~     The goals of the current study, based largely upon the core principles of the Social~     Ecological Model, are to design, implement, and evaluate an innovative multi-level~     intervention promoting physical activity among churchgoing Latinas.~      The evidenced-based intervention targets three tiers of environmental influences (i.e.,~     church, immediate neighborhood surrounding the church, and community) on activity, as well as~     MVPA-related personal factors (i.e.., intra/interpersonal, cultural, and perceived~     environmental variables). The physical activity intervention will be compared with an~     attention-control condition providing health education on cancer prevention and control via~     screening.~      Sixteen churches will be randomly assigned to either the physical activity intervention or~     the attention-control condition. The primary aim of the study is to determine whether a~     multi-level intervention will increase MVPA among Latina churchgoers in the intervention~     condition relative to the attention-control condition.~   "
136800|NCT01776619|"~     Safety, tolerability and PK of repeated doses of PF-06305591 will be evaluated in young~     healthy volunteers toghether with food effect on relative bioavailability of solid~     formulation after single dose.~   "
136801|NCT01776606|"~     This study will evaluate the efficacy and safety of botulinum toxin type A compared to~     placebo control for the treatment of moderate to severe crow's feet lines.~   "
136802|NCT01776593|"~     To identify the bladder diary parameters that are best correlated to VSD.~   "
140047|NCT01734265|"~     The primary objective of this study is to evaluate the safety and tolerance of a rush build~     up administration of Depigoid forte pollen and the first maintenance dose administered 4~     weeks later.~   "
136804|NCT01776567|"~     The purpose of the trial is to directly compare the Cobalt Chromium platform~     everolimus-eluting stent, Xience Prime™, with the Platinum Chromium platform~     everolimus-eluting stent, Promus Element™, in relation to stent scaffolding shape, position~     with the heart blood vessel and extent of tissue coverage (at 6 months) using optical~     coherence tomography.~      Hypotheses:~        1. The alloy composition and strut design of a drug-eluting stent has a direct bearing on~          stent apposition measured using OCT.~        2. Stent design and alloy composition have a direct influence on radial support and~          scaffold shrinkage.~   "
136805|NCT01776554|"~     Evaluate Safety, Tolerability and Immune response of adjuvanted H5N1 cell culture derived~     influenza vaccine in children.~   "
136806|NCT01776541|"~     Evaluate Safety, Tolerability and Immune Response of Adjuvanted H5N1 Cell Culture Derived~     Influenza Vaccine in Adult Subjects.~   "
136807|NCT01776528|"~     The purpose of this study is to determine the safety and tolerability of NGM282, both single~     dose and multiple doses, in normal healthy adult participants.~   "
136808|NCT01776515|"~     The purpose of this study is to evaluate effectness of Tramadol Hydrochloride/Acetaminophen~     SR Tab. and Tramadol Hydrochloride/Acetaminophen Tab. in patients with low back pain.~   "
136809|NCT01776502|"~     The purpose of this study is to evaluate the evolution of the non specific symptoms for 116~     patients with mild primary hyperparathyroidism before and 3, 6 and 12 months after surgery. A~     clinical score predicting clinical improvement at one year will be created.~   "
136810|NCT01776489|"~     Food allergies represent an increasing health concern in the industrialized countries and~     especially affect pediatric patients. In this population adverse reactions against food~     compounds can lead to anaphylactic reactions. Despite substantial research efforts, clinical~     markers predicting disease severity and symptoms are missing to date.~      Recent studies have revealed that sphingolipids, especially sphingosine-1-phosphate (S1P),~     play an essential role in allergy. It was reported that asthmatic patients have higher S1P~     levels in bronchiallavage fluids after allergen challenge. First experimental studies~     revealed a correlation of S1P and the outcome of anaphylaxis. Furthermore, we have shown in~     our recent mouse study that S1P homeostasis is pivotal for food allergy induction and~     effector cell response. Therefore, it is the aim of the presented pilot project to evaluate~     whether S1P serum titers are altered in food allergic children and if the S1P levels~     correlate with the outcome of anaphylaxis during double blind placebo controlled food~     challenges (DBPCFCs).~   "
136811|NCT01776476|"~     The purpose of this study is to find out if giving certain amino acids to critically injured~     patients can improve their condition or recovery, and lower their blood sugar and insulin~     needs. Amino acids are the 'building blocks' of proteins. The amino acid compound used in~     this study is called alanyl-glutamine dipeptide, also known as Dipeptiven® or glutamine.~     Glutamine is investigational, meaning not approved by the Food and Drug Administration (FDA)~     for intravenous use. However, it is approved by many countries in Europe, Asia and South~     America. Several studies suggest that giving glutamine has certain benefits in patients who~     need intensive care. In a study done at Emory University Medical Center using the same dose~     of glutamine, the number of hospital infections was lower in patients who had had cardiac,~     blood vessel or intestinal surgery compared to similar patients who received standard~     feedings without glutamine. No side effects were thought to be due to giving glutamine in~     that small study. This study is only being done at Vanderbilt University. The investigators~     plan to enroll 24 patients in the Trauma ICU over the next 12 months.~   "
136812|NCT01776463|"~     The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics~     (including food effect) of single and multiple doses of Z-360 in healthy Japanese subjects.~   "
136813|NCT01776450|"~     To treat patients with abdominal aortic aneurysms requiring endovascular repair outside of~     the clinical protocol through compassionate use.~   "
136814|NCT01776437|"~     This is a randomized, 2-period, 2-sequence crossover study to evaluate the effect of food on~     the relative bioavailability of BMN 673 during fasting and fed conditions in healthy male~     subjects.~   "
136815|NCT01776424|"~     The primary purpose of this study is to evaluate whether treatment with rivaroxaban and~     aspirin or rivaroxaban alone is better than aspirin alone in prevention of heart attacks,~     stroke or cardiovascular death in patients with coronary or peripheral artery disease.~   "
136816|NCT01776411|"~     Phase I portion:~      To confirm safety and tolerability in recurrent/refractory peripheral T-cell lymphoma~     patients during repeated oral administration of forodesine 300 mg twice daily (600 mg/day)~     for 28 days, and determine the recommended dose. Also, to evaluate pharmacokinetics.~      Phase II portion:~      To evaluate the efficacy, safety, and pharmacokinetics of the recommended dosage regimen~     determined in the phase I portion. The primary efficacy endpoint shall be objective response~     rate (ORR).~   "
136817|NCT01776398|"~     The purpose of this study is to obtain biologic materials from the blood, airways and/or~     urine of normal individuals and individuals with lung disease. The normal are used to~     establish a set of normal ranges for various parameters. These provide control information~     when compared to individuals with various pulmonary diseases, and will help in understanding~     of the etiology and pathogenesis of various lung diseases. The underlying hypothesis is that~     the pathologic morphological changes in the airway epithelium must be preceded by changes in~     the gene expression pattern of the airway epithelium and potentially in macrophages.~   "
136848|NCT01775995|"~     Chronic low back pain (CLBP) is one of the most common, costly and disabling conditions. It~     is often refractory to treatment, with patients requiring long-term opioid therapy.~     Mindfulness meditation is a promising treatment for chronic pain, mental health and addictive~     disorders. When combined with cognitive behavioral therapy (CBT), a standard of care for~     CLBP, it may produce additive benefits. The goal of this randomized controlled trial (RCT) is~     to evaluate the feasibility and efficacy of an innovative behavioral intervention to improve~     the health of adults with opioid-treated CLBP. This RCT will test the hypotheses that, at 26~     weeks, meditation-CBT group participants (meditation-CBT + usual care), compared to those in~     a wait-list control group (usual care alone), will improve health-related quality of life~     (primary outcomes: pain severity and physical function) and reduce opioid medication use~     (secondary outcome). In addition, they will also decrease alcohol and drug use/misuse, and~     improve stress-sensitive measures and economic outcomes.~   "
136818|NCT01776385|"~     Malignant pleural mesothelioma (MPM) has a growing incidence and in spite of early~     diagnostic, their outcome remains dismal. The evolution of MPM is often local with rare~     distant metastases. There is now a sizable body of evidence that metastases could develop~     from circulating tumor cells (CTC) spread in blood before or during surgery. Thus, sensitive~     and specific detection of CTC in blood is considered as a potentially relevant predictive~     biomarker for patients with carcinomas. In exchange, the prognostic value of CTC in MPM has~     not yet been evaluated.~      Indeed, the main goal for preoperative detection of CTC is to identify patients with high~     risk of recurrence after surgery, in order to perform more adapted therapeutic strategy.~     Despite several studies reported about CTC detection, methodological aspects concerning~     sensitivity, specificity and reproducibility have prevented a clear appraisal of their~     clinical impact. Thus, the aim of our study is to evaluate the presence and the prognostic~     value of CTC in MPM by a double approach. In our setting, cytopathological analysis of~     circulating non hematological cells (CNHC), of epithelial origin, isolated according to their~     size (ISET, Isolation by Size of Epithelial Tumor cells) along with immunomagnetic selection,~     identification and enumeration of circulating epithelial cells in peripheral blood~     (CellSearch method) is considered a promising approach.~   "
136819|NCT01776372|"~     The chest cavity contains a small amount of fluid (pleural effusion). In normal circumstances~     this fluid is kept in balance. When surgery is performed on the lung, there can be~     accumulation of more fluid due to many causes. In order to drain this additional amount of~     pleural fluid, chest tube(s) are left in the thoracic cage after a lung resection procedure.~     The investigators are attempting to reduce the amount of pleural fluid production and~     formation by using a more balanced thoracic drainage system, which adjusts the amount of~     suction depending on the needs of the patient. That way, the amount of inflammation in the~     thoracic cage might be smaller, and hence less fluid will be formed. By this, the~     investigators are hoping that the chest tubes can be removed earlier, and the patients can be~     discharged faster and will potentially have a lower rate of re-admission to the hospital~     after surgery due to problems related to the fluid in the thoracic cage.~   "
136820|NCT01776359|"~     A four week intervention will take place with the participants. They will undergo 6 days a~     week of high intensity training. They will also be at a 40% energy deficiency. One group will~     have a normal intake of protein, 1.2g/kg, while the other will have 2.4g/kg. It is our thesis~     that the participants with the higher protein will retain more lean mass.~   "
136821|NCT01776346|"~     The ultimate goal of the Barrett's Esophagus Patient Registry is to help develop more~     effective targeted screening strategies and treatment options for Barrett's esophagus and~     esophageal adenocarcinoma (EAC). We plan to do by developing a registry that will serve as a~     platform. Examples of analyses could include identifying genetic determinants and biomarkers~     that predict BE, progression of BE to EAC, as well as the response to therapies.~   "
136822|NCT01776333|"~     Randomized Controlled Trial of a Video Decision Aid in the ICU in surrogates of admitted~     patients.~   "
136823|NCT01776320|"~     A Phase 4 clinical trial that is open, with no blinding of subjects or randomization of~     treatment. Patients with erectile problems will be given the approved drug Vitaros to treat~     their condition. They will be given forms and questionnaires to complete. The information~     collected will be used to assess the effectiveness, safety and the satisfaction levels with~     this drug.~   "
136824|NCT01776307|"~     This is an open label, multi-center, Phase 2 study of BBI608 in combination with cetuximab,~     panitumumab or capecitabine in patients with advanced colorectal cancer.~   "
136825|NCT01776294|"~     Student Investigator = Thakkallapalli Zeeshan Muzahid. The study aims to assess the~     prevalence of prehypertension among medical students of Andhra Medical College,~     Visakhapatnam, India and its association with other cardiovascular risk factors - overweight~     /obesity, diabetes, lipid profile.~   "
136826|NCT01776281|"~     - Hypothermia, infections ,and ineffective breastfeeding are some of the commonest causes of~     deaths among premature and low birth weight LBW infants. Even if the infants are born in~     facilities, incidences of cold stress are possible due to insufficient resources, space and~     incompetent practices to manage hypothermia in the immediate postnatal period. Kangaroo~     Mother Care is a well-known intervention to address the issues related to preterm births,~     such as hypothermia, infection and prolong hospitalization.Besides significant outcome of KMC~     interventions for preterm infants, no interventional study has been found in literature in~     Pakistani context. Looking at the potential benefits of KMC in reducing the related~     complications of prematurity, the study aims to identify the effectiveness of KMC among~     preterm and LBW infants born in secondary hospital of Aga khan University hospitals.~      Hypothesis I Ha: KMC is effective in reducing the incidences of hypothermia among preterm and~     LBW infants as compared to the usual care.~      Hypothesis II Ha: There is a difference in breastfeeding behavior and breastfeeding outcome~     among experimental and control group.~      Secondary Hypothesis Hypothesis I Ha: There is an association between KMC and frequency of~     suspected infections during hospitalization.~      Hypothesis II Ha: There is a difference in length of stay among experimental group and~     control group.~      Hypothesis III Ha: There is a relationship between KMC and weight gain of infants till four~     weeks.~      Hypothesis IV Ha: There is difference in rate of hypothermia among experimental group and~     control after discharge from hospital.~   "
136834|NCT01776177|"~     The primary objective is to assess the clinical effectiveness of long-term omalizumab therapy~     in 240 patients treated over an 8 year period in a real-life clinical setting and to compare~     the pre- and post-treatment clinical characteristics to identify and better understand the~     markers of response to omalizumab.~      To date, there are no established criteria for identifying 'response' to omalizumab therapy.~     Currently, the commonly accepted clinical criterion for omalizumab treatment response is the~     physician's overall assessment, GETE (Global Evaluation of Treatment Effectiveness). Most~     clinical trials have evaluated the efficacy of omalizumab treatment after a 16 week treatment~     period and lack the impact of long-term omalizumab therapy.~      Investigators propose multiple approach modules to better assess and identify 'response' and~     to define 'responders' to omalizumab and evaluate the long-term impact in a real-world~     clinical practice. Besides evaluating individual outcome variables, it is important to~     attempt the 'clustering of variables' to further investigate if any baseline clinical~     phenotypes are predictive of better response enabling us to refine the patient population who~     will gain most benefit from therapy.~   "
136827|NCT01776268|"~     Background:~      Infection in preterm infants is a common, costly, and devastating problem frequently causing~     death or sequelae for survivors. An immature immune system underlies the frequency and~     severity of infections in this vulnerable population. The mouth is the site where microbes~     first meet the mucosal immune system. Antimicrobial proteins and peptides (APPs) in saliva~     kill microbes and improve immune cell function. Low APP levels increase the risk of~     developing infection. Colostrum and human milk reduce the risk of infection. This protective~     effect of human milk may come from supplying or stimulating infant production of APPs. No~     prior investigation has determined the concentration of APPs in saliva or the effect of human~     milk/formula on the APP concentrations in saliva.~      Objective(s) and Hypothesis(es):~      The investigators objectives are to identify and serially determine the concentrations of key~     APPs in colostrum, human milk, and preterm infant saliva using highly-sensitive and specific~     mass spectroscopy methods. The investigators study is designed to test the hypotheses that~     (a) all saliva APPs increase over time, (b) APP concentrations are higher in colostrum as~     compared to human milk, and (c) APPs are increased in saliva of infants that receive~     colostrum orally compared to those that do not.~      Potential Impact:~      If increased saliva APP levels are associated with oral colostrum priming, this discovery~     would advance understanding of the immune properties of human milk and identify oral APPs as~     important immune elements and potential therapeutic targets in this vulnerable population.~     This knowledge has the potential to alter feeding practices and provide a safe, low cost~     means to improve immune function and significantly improve outcomes for preterm infants.~   "
136828|NCT01776255|"~     Healthy Children, Strong Families-2 (HCSF-2) is a family focused early childhood intervention~     which addresses the growing problem of childhood obesity in American Indian communities. The~     study works with six rural and urban American Indian communities across the US to test the~     ability of the intervention to increase adoption of healthy lifestyles and to reduce the~     prevalence of obesity among preschool aged American Indian children and their primary~     caregivers - creating healthier children, healthier families and healthier communities. Our~     primary hypothesis is that children and their primary caregivers who receive the HCSF-2~     intervention will have better obesity related outcomes than those who do not receive HCSF-2.~   "
136829|NCT01776242|"~     The overall objective of BOLD is to establish a large, community-based registry (at least~     5000 subjects) of patients aged 65 years and older presenting with new episodes of healthcare~     visits for back pain. BOLD's primary aim is to create an infrastructure that allows for the~     conduct of prospective, controlled studies comparing the effectiveness of diagnostic and~     treatment strategies for back pain in older adults.~   "
136830|NCT01776229|"~     Untreated trauma-related nightmares and sleep-related disorders are associated with chronic~     health problems, burdening both the suffering individual and the health-care system. The~     study implements an innovative, cost-efficient, nightmare treatment for trauma-exposed~     children. It is the first randomized clinical trial with children, adapting an efficacious~     adult therapy to a 5-session nightmare treatment for 5-17 year-olds. Trauma nightmares are a~     mechanism in development and maintenance of secondary post-trauma psychopathology, medical~     problems and family dysfunction. Therefore, this treatment may prevent long-term secondary~     health and behavioral problems. It provides a viable healthcare option to Oklahomans,~     lessening long-term financial medical and behavioral health expenses. Scientific models~     currently view PTSD treatment as primary, often leaving nightmares untreated. That approach~     does not address the pernicious impact of trauma-nightmares in individuals with sub-threshold~     PTSD or whose nightmares are a primary condition. The theoretical innovation of this therapy~     can advance the field's understanding of the development of trauma sequelae.~   "
136831|NCT01776216|"~     Hypertension and endothelial dysfunction are being increasingly recognized as key etiological~     factors in the development of atherosclerosis and subsequent cardiovascular disease (CVD). A~     substantial body of evidence indicates that treating patients with elevated blood pressure~     (BP) leads to marked reduction in the risk of stroke, myocardial infarction, heart failure,~     and renal failure. There is also accumulating evidence associating endothelial dysfunction,~     which is defined as incapacity of the arteries to vasodilate when required, to elevated BP~     and an increased risk of CVD.~      While there are more and more studies on how diet affects BP in healthy subjects, the impact~     of dairy consumption per se on both endothelial function and ambulatory BP has not been well~     characterized in patients with established essential hypertension. Therefore, the general~     objective of the study is to investigate in a single-blind randomized controlled study the~     impact of dairy consumption on ambulatory BP and endothelial function in subjects with mild~     to moderate essential hypertension.~   "
136832|NCT01776203|"~     In this study, the investigators would like to see if giving medroxyprogesterone acetate for~     3 weeks after Leuprolide acetate injection will help to decrease this amount of bleeding,~     decrease the amount of nausea, bloating and cramping and increase patient satisfaction~   "
136833|NCT01776190|"~     The investigators are conducting an open-label clinical trial determining the effects of UVA1~     phototherapy on cutaneous lupus (CLE) patients. Past research on systemic lupus (SLE)~     subjects indicates that this treatment is likely to be effective in treating cutaneous lupus~     with few side effects. The fact that most CLE patients are seen at dermatology clinics also~     increases the usefulness of this study because there is a large probability that phototherapy~     treatment will be accessible for many of the patients that stand to benefit from it.~   "
136847|NCT01776008|"~     This phase II trial studies how well Akt inhibitor MK-2206 (MK-2206) and anastrozole with or~     without goserelin acetate works in treating patients with stage II-III breast cancer. MK-2206~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~     Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole and~     goserelin acetate may fight breast cancer by blocking the use of estrogen by the tumor cells.~     Giving MK-2206, anastrozole, and goserelin acetate together may kill more tumor cells.~   "
136888|NCT01775475|"~     This randomized phase II trial studies how well intravenous (IV) chemotherapy or oral~     chemotherapy works in treating patients with previously untreated stage III-IV human~     immunodeficiency virus (HIV)-associated non-Hodgkin lymphoma. Drugs used in chemotherapy,~     such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, prednisone,~     lomustine, etoposide, and procarbazine hydrochloride, work in different ways to stop the~     growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving~     more than one drug (combination chemotherapy) may kill more cancer cells~   "
136835|NCT01776164|"~     Friedreich's ataxia is characterized by progressive alterations in the function of the~     cerebellum accompanied by an atrophy of the spinal cord. Although the genetic defect~     responsible for the disease has been identified more than 15 years ago, objective markers of~     the pathologic process (i.e., biomarkers) that would allow measuring the effects of potential~     therapies are still lacking. Moreover, it is still unclear how the malfunction of the~     cerebellum affects the rest of the brain, and understanding the connectivity and~     neurochemistry of the central nervous system might yield new insights in the understanding of~     the disease, in addition to providing potential markers.~      To address these needs, the investigators aim at utilizing the capabilities of Magnetic~     Resonance Imaging (MRI) and Spectroscopy (MRS). Using techniques called Diffusion Imaging,~     resting-state functional MRI, and Proton Spectroscopy (1H MRS), the investigators propose to~     determine the differences in the connectivity and neurochemistry of the spinal cord and the~     brain between patients affected by Friedreich's ataxia and healthy controls. The~     investigators plan on imaging both patients and control subjects using a 3T magnet, a system~     that although not yet available in all medical facilities, is becoming standard in most~     hospitals and clinics. The first aim is to scan patients already scanned last year (12-month~     follow-up). The second aim is to scan patients at an early stage of the disease.~   "
136836|NCT01776151|"~     The purpose of this study is to find out if starting anti-retroviral therapy (ART) above 500~     cluster-of-differentiation-4 (CD4)+ cells/milliliter (mL) ('early ART group') is better at~     reducing the stiffness of arteries than waiting to start ART until the CD4+ drops below 350~     cells/mL ('deferred ART group'). Artery stiffness has been associated with an increased risk~     of cardiovascular (heart) disease, and could be useful as an earlier indicator of heart~     disease. In this study, the stiffness of arteries will be measured at study entry, months 4,~     8, 12, and annually thereafter, using a tonometer on the participant's forearm.~   "
136837|NCT01776138|"~     The purpose of this study is to create a registry of older patients undergoing surgical~     and/or medical treatment for bladder cancer. The registry will record side-effect and~     outcomes related to the treatment using different surveys and biological measures.~   "
136838|NCT01776125|"~     Neurofibromatosis (NF) is a common genetic disorder that cause tumors to grow along various~     types of nerves and, in addition, can affect the development of bones and skin. It occurs in~     1:4000 persons. NF has been classified into three distinct types: NF1, NF2 and~     Schwannomatosis. NF1 is the focus of this study.~      NF1 is an extremely variable disorder which ranges from extremely mild cases in which the~     only signs of the disorder in adulthood may be multiple café-au-lait spots and a few dermal~     neurofibromas, to more severe cases like disfigurement, scoliosis and learning disabilities.~     Scoliosis (abnormal curvature of the spine) is perhaps the most common bone deformity in NF1~     which usually appears in early childhood. There are two types: dystrophic and non-dystrophic~     scoliosis. Dystrophic scoliosis is usually associated with other bone deformities which are~     seen on x-ray and carries a poorer prognosis than non dystrophic scoliosis. There is evidence~     that genes other than the NF1 gene are responsible for the variable severity of cases. Recent~     studies have identified genetic markers for another condition called adolescent idiopathic~     scoliosis (scoliosis which presents in adolescent age group with no known cause). We believe~     that the same genetic markers may also be present in NF1 patients with scoliosis.~      Our objective is primarily to determine if the same genetic markers discovered in adolescent~     idiopathic scoliosis are also present in NF1 patients with scoliosis.~   "
136839|NCT01776112|"~     To explore: (a) if physical exercise (sports) combined with cognitive training leads to~     (superior) improvement of cognition in schizophrenia compared to sports or cognitive training~     alone (b) if a sports program alone or in combination with cognitive training has influence~     on hippocampal pathology and synaptic plasticity in schizophrenia compared to a placebo~     condition.~   "
136840|NCT01776099|"~     In animal models and retrospective studies, certain food components such as sugars and fiber~     have been detected as potential agents to influence development and progress of type 2~     diabetes.~      The DiNA study prospectively investigates, if non-soluble non-fermentable fibers (vs. soluble~     ones) and galactose (vs. palatinose) are capable to improvement metabolic parameters in~     patients with long-term type 2 diabetes and intensive insulin treatment.~   "
136841|NCT01776086|"~     The purpose of this studying is to develop and characterize neuropsychological testing~     software for evaluating the prefrontal and temporal function of patients. As no software has~     been used for this purpose, this study will gather pilot data on the baseline performance of~     patients in a hospital setting that lack any neurological impairment. After creating this~     baseline, later experiments can be proposed to compare the performance in normal subjects~     with those who have neurologic injury or disease.~   "
136842|NCT01776073|"~     The purpose of this study is to measure the effect of introducing a patient navigator to~     guide high and moderate risk patients through the pre-waitlisting phases of the kidney~     transplant process. Patients identified as being at high and moderate risk of delay to~     waitlisting will be linked with a patient navigator, who will facilitate their completion of~     pre-waitlisting requirements. We believe that patients who are randomized to a patient~     navigator will be more likely to complete the pre-waitlisting process and will complete the~     process more quickly than high and moderate risk patients who do not receive additional~     assistance from a patient navigator.~   "
136843|NCT01776060|"~     The goal of this study is to enroll 100 participants with Primary Progressive Multiple~     Sclerosis (PPMS) that have joined the MURDOCK Study Horizon 1.5 (Duke IRB Pro00011196) and~     the Multiple Sclerosis cohort (Duke IRB Pro00023791). All 100 participants will complete a~     biannual collection of a follow up questionnaire and blood/urine collection for a period of 5~     years.~   "
136844|NCT01776047|"~     Study Design : randomized, open label, single-dose, 2-way cross-over design~      Phase : Phase I~   "
136845|NCT01776034|"~     The objective of this study is to conduct a randomized controlled pilot study to examine the~     efficacy, feasibility and safety of the SystemCHANGE™ health promotion and wellness program~     in stroke survivors. The central hypothesis of the study is that the SystemCHANGE™ program~     will help overweight and obese stroke survivors engaging in healthy behaviors, thereby~     improving health and function.~   "
136846|NCT01776021|"~     The purpose of this study is to compare the effects of a cranberry juice beverage on rates of~     Urinary tract infection (UTI) recurrence in women with a history of UTI.~   "
136849|NCT01775982|"~     To validate the French version of the CAM, a multicenter diagnostic study will be conducted.~     The principle of this study is identical to the study of Inouye which initially validated the~     CAM in 1990. This is to verify the diagnostic properties of the CAM (French version) compared~     to the gold standard represented by the confused state of psychiatric diagnosis using the~     DSM.~      A representative sample of geriatric patients for whom a delirium is suspected, will be~     recruited in the various participating centers, patients will undergo two consecutive visits:~        -  A visit by a geriatrician, during which the confused state of the patient will be~          evaluated using the French version of the CAM.~        -  A visit by a psychiatrist during which the diagnosis of confusional state will be~          evaluated using the gold standard criteria of the DSM IV.~      These two evaluations will be conducted on the same day and blinded from each other.~      The order of these two procedures will be balanced within each center. This process will~     allow the calculation of diagnostic parameters of the CAM French version (validation~     competitive): sensitivity, specificity, positive and negative predictive values .~   "
136850|NCT01775969|"~     Outpatient antibiotics are frequently prescribed from the emergency department, and limited~     health literacy may impact compliance with recommended treatments. The investigators are~     looking to determine if patient preference for multimodality discharge instructions for~     outpatient antibiotic therapy varies by health literacy level, and if modality effected~     patient-reported antibiotic compliance and 72-hour antibiotic pick-up.~   "
136851|NCT01775956|"~     Septic shock remains the dominant cause of death in ICU's of the developed world with~     approximately 400,000 cases annually in the US and another 20,000 annually in Canada. While~     many retrospective and prospective reviews of septic shock patients have been undertaken~     worldwide, many key questions remain unanswered. These questions include the true incidence,~     associated morbidity and mortality of septic shock in North America, key factors associated~     with successful management and markers suggesting a high probability of a complicated~     clinical course. Part of the reason for the persistence of these questions, is the fact that~     previous and ongoing reviews of septic shock and severe sepsis have been either limited in~     number (typically <150) or biased by the need to be eligible for specific clinical trials~     (typically, non-eligible patients have not been followed and had data collected.~      We propose to examine specific questions within a temporally comprehensive cohort of septic~     shock patients by review of individual charts using a defined data-extraction template.~   "
136852|NCT01775943|"~     Lung cancer is the leading cause of cancer-related death worldwide and is well known to~     remain a major health problem. Non-small-cell lung cancer (NSCLC) constitutes more than 80%~     of all the cases of lung cancer.~      Today, NSCLC can be defined by various molecular criteria. Especially, somatic mutations~     within the epidermal growth factor receptor (EGFR) gene itself were discovered in a subset of~     NSCLC patients.~      Two activating EGFR mutations are in-frame deletion in exon 19 and the substitutions for~     L858R in exon 21, which account for 85% of all clinically important mutations related to EGFR~     TKI sensitivity.~      Besides two activating EGFR mutations, other EGFR mutations in NSCLC have been discovered.~     G719 and L861 are reported to have intermediate sensitivity to EGFR TKI. And in-frame~     insertions within exon 20 and T790, which are known to be resistant to EGFR TKIs.~      However, there are still other EGFR mutations such as E709 and S768 as well as doublet EGFR~     mutations are also observed. These rare mutations have not been fully described and data on~     their correlation with response to EGFR-TKIs are still unclear.~      Research hypothesis Rare EGFR mutations of unknown clinical significance in NSCLC patients,~     which are distinguish from mutations such as deletion in exon 19, L858 and insertion in exon~     20, have some possibility of EGFR TKI sensitivity.~      Rationale for conducting this study It has an opportunity to be shown the efficacy of EGFR~     TKIs in patients with rare EGFR mutation in large number of patients in Korea (Asia) during~     the short period.~   "
136853|NCT01775930|"~     The goal of this clinical research study is learn if carfilzomib can help control kidney~     cancer. The safety of this drug will also be studied.~      Carfilzomib is designed to block cancer cells from repairing themselves. If the cancer cells~     cannot repair themselves, this may cause them to die.~   "
136854|NCT01775917|"~     During the recent decades the need for surgical evacuation of the uterus in early~     miscarriages and incomplete miscarriages has been questioned.~      It has been shown that an observational approach can be, in many cases, as good as an~     invasive one without increasing the incidence of uterine infections.~      it has been shown that misoprostol - prostaglandin E1 given for missed abortions is~     successful in emptying the uterus in 85% of cases without any need for surgical intervention.~     and during recent years many women prefer this approach than the surgical one .~      Many have tried using sonographic signs such as endometrial thickness, the presence of a~     gestational sac, and color doppler to differ between blood clots and a gestational residua in~     uterus, and to decide according to these signs wether there is a need for surgical evacuation~     or an expectant management could be used. but none of these methods have been proven to be~     completely efficient as predictors.~      In this study the investigators will examine whether the doppler indices in the uterine~     arteries can help to predict which gestational residua needs surgical evacuation of the~     uterus and which could be managed expectantly.~      The study hypothesis is that the resistance in uterine artery doppler will be lower in cases~     with intrauterine residua as opposed to high resistance in cases without residua.~   "
136855|NCT01775904|"~     The purpose of this study is to evaluate two different formulations of LY2886721. In~     addition, this study will determine how much of study drug (LY2886721) gets into the blood~     steam and how long the body takes to get rid of it after taking each formulation with or~     without a meal. Information about any side effects that may occur will also be collected.~     Each participant may be involved in the study for approximately 7 weeks.~      This study requires 4 periods. In each period, participants will receive LY2886721 as a~     tablet or capsule, with or without food and water. There is a 7 day washout between each~     period.~   "
136856|NCT01775891|"~     Investigators hypothesized that the use of Pilsicainide after radiofrequency ablation of AF~     could reduce the incidence of recurrence of atrial arrhythmia during follow up compared with~     other class IC antiarrhythmic drugs.~   "
137458|NCT01768026|"~     The objective of this study is to characterize the extent and severity of disease in subjects~     with DEB and the progression of disease over a timeframe relevant to interventional studies.~     The data from this study will be used to inform the study design and address statistical~     considerations of future treatment protocols.~   "
136857|NCT01775878|"~     The study is a two-arm, parallel-comparison, single-blind, randomized controlled trial, and~     will be offered to Kaiser Permanente members aged 18 - 75 years old who present to the Santa~     Rosa Diabetes Care Management Center with Type 2 diabetes mellitus. Participants will be~     randomly assigned to one of two treatment arms. The telemedicine group or the group receiving~     usual care (the control group).~      This study hopes to show the usefulness of this telemonitoring technology and more~     specifically, to assess whether this device improves markers of control of diabetes, glycemic~     control, and cardiovascular risk factors~   "
136858|NCT01775865|"~     Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in the United~     States with older age being a primary risk factor. The number of adults greater than age 65~     years will almost double to 70 million by 2030, therefore identifying therapeutic strategies~     for treating or preventing age-related disorders in humans is of major biomedical importance.~     Cardiovascular aging, defined as a reduction in vascular and cardiac functions with normal~     aging, occurs even in the absence of CVD risk factors and overt CVD. A key feature of~     cardiovascular aging is stiffening of the large elastic central arteries such as the aorta.~     This is important because aortic stiffness directly contributes to clinical problems such as~     increased blood pressure, reduced blood flow to the heart muscle, and thickening of the heart~     muscle. Therefore, these clinical consequences are hypothesized to mediate a substantial~     proportion of the increase in CVD risk in older adults. However, effective drug treatments~     for aortic stiffness are not currently available and the biological reasons (mechanisms)~     involved in causing aortic stiffening remain undefined. In addition, the inability of smaller~     blood vessels to relax, impairment of the heart to relax during the filling phase of the~     heart cycle (i.e., diastole), and increased blood pressure variability, have all been linked~     to aortic stiffness. Furthermore, chronic low-grade inflammation with advancing age has been~     proposed to be a common mechanistic link (i.e., biological reason) between these reductions~     in cardiovascular function in older adults. Therefore, the investigators propose that~     inflammation could be a novel therapeutic target to treat cardiovascular aging in older~     adults. Our central hypothesis is that inflammation mediates the age-related deterioration in~     cardiovascular functions observed with advancing age through the development of oxidative~     stress (i.e., imbalance between damaging oxygen free radicals vs. protective antioxidants).~     Our hypothesis predicts that chronic inhibition of inflammation with Salsalate, an~     FDA-approved anti-inflammatory drug similar to aspirin that is used to treat rheumatoid~     arthritis pain and known to inhibit the 'master' regulator of inflammation in the cell (i.e.,~     nuclear factor kappa B), will improve cardiovascular function in older adults. In addition,~     the investigators hypothesize that the mechanism for the improvement in cardiovascular~     function during inhibition of inflammation will be by suppressing oxidative stress. To test~     our hypothesis, the investigators will randomize older healthy adults (age 50-79 years) to 3~     g/day of salsalate or placebo (i.e., pill with inactive substance) pills for 4 weeks and have~     cardiovascular function measured at baseline and again after 4 weeks.~   "
136859|NCT01775852|"~     The purpose of this research study is to examine whether a one-day group workshop,~     integrating principles from Acceptance and Commitment Therapy with Migraine Education, will~     result in improvements in depressive symptoms and functioning impairment in patients with~     comorbid migraine and depression.~   "
136860|NCT01775839|"~     Clinical trial to evaluate the influence of multiple aspirin administration on PK and PD of~     co-administered drugs~   "
136861|NCT01775826|"~     The majority of the US population spends most of the day sitting and the we have new~     scientific evidence that this can contribute to poor health regardless of how much physical~     activity a person does. However, we do not measure sitting time very accurately and when we~     ask people to tell us how much they do, their answers are unreliable. Our study will use~     small sensors to objectively measure when people sit or do physical activity, and we will use~     sophisticated computational techniques to summarize these movement patterns.~   "
136862|NCT01775813|"~     The Health Influences of Puberty (HIP) Study is designed to explore the relationships between~     puberty and the onset of type 2 diabetes in adolescents. The results of this study will help~     us better understand how to prevent type 2 diabetes in these youth. Children go through many~     changes during puberty, including important hormonal and behavioral alterations. Among these~     changes, it has long been known that, during puberty, insulin does not work as well as it~     does before and after puberty. This is called physiologic insulin resistance. In healthy~     children, this does not cause diabetes or affect blood sugar in any way because the body is~     able to compensate by making more insulin. Indeed, this is thought to be an important part of~     the adolescent growth spurt. However, in some children with increased risk for developing~     type 2 diabetes due to obesity and genetics, the worsening insulin resistance of puberty~     cannot be compensated for and these youth get diabetes early. The investigators believe this~     is because type 2 diabetes is rarely, if ever, seen before puberty begins, and the peak of~     diabetes onset in adolescents occurs at the time of the worst insulin resistance. This~     specific research project has two goals: 1. To examine effects of obesity on how well the~     body's insulin works during puberty, and 2. To see if treatment of obese children during this~     critical period of puberty with a medication that improves insulin resistance (metformin)~     will help prevent early onset type 2 diabetes.~   "
136863|NCT01775800|"~     Many patients on hemodialysis experience high rates of symptom burden, such as pain,~     depression, anxiety and difficulty breathing. This study seeks to reduce these symptoms by~     modifying the usual guidelines used to manage patients on hemodialysis. For example, rather~     than trying to keep serum phosphorus below 5.5, patients enrolled in this study may have~     treatment goals of less than 6.5, in order to reduce the number of pills they need to take~     and potentially reduce harmful side effects. Blood pressure and serum parathyroid hormone~     goals will also be modified, to see if these modifications help hemodialysis patients feel~     better.~   "
136864|NCT01775787|"~     This study will examine whether nicotine levels increase with electronic cigarettes. It will~     also examine whether electronic cigarettes alter lung function tests. The study will obtain~     preliminary data on the medical effects of electronic cigarettes, with two different nicotine~     flavors, tobacco and tobacco with menthol, which are available for over the counter purchase.~      The electronic cigarettes and juice used in this study is available for purchase through the~     internet. An investigational new drug application (IND) is not needed for this study.~   "
136865|NCT01775774|"~     This is a Phase 1, open label, dose escalation, multi-center clinical trial of Allogeneic~     Bone Marrow-Derived Human Mesenchymal Stem Cells (hMSCs) for the treatment of Acute~     Respiratory Distress Syndrome (ARDS). The purpose of this study is to assess the safety of~     hMSCs in patients with ARDS.~   "
136866|NCT01775761|"~     The purpose of this study is to investigate the effects of tafamidis on the intervals of the~     electrocardiogram, specifically the rate corrected QT interval (QTc) in healthy volunteers.~   "
136900|NCT01775319|"~     Study part 1 and 2 Assessment of Zn absorption from regular and biofortified wheat: stable~     isotope absorption studies in women of childbearing age consuming test meals prepared from~     either the biofortified Zn wheat, regular wheat or post-harvest fortified wheat at two~     different extraction rates.~      Study part 3 Assessment of Zn absorption from intrinsically and extrinsically labeled wheat:~     stable isotope absorption studies in women of childbearing age, or men, consuming test meals~     prepared from either intrinsically labeled Zn biofortified wheat, regular wheat or~     post-harvest fortified wheat extrinsically labeled immediately before consumption.~   "
136867|NCT01775748|"~     The study will compare Concord grape juice to a beverage that contains no grape flavonoids,~     but has a similar appearance and taste (placebo juice). A total of 60 overweight and obese~     participants over age 50 will be enrolled. Each participant will drink each beverage for 4~     weeks with a 2-week rest period between two beverage consumption periods. The order of~     beverages (grape juice first or placebo juice first) will be randomized. The investigators~     will use ultrasound to measure brachial artery flow-mediated dilation, a measure of~     endothelial vasodilator function. The investigators will also collect blood samples to~     further assess the cardiovascular effects of grape juice.~      The aim of the study is to determine whether Concord grape juice improves endothelial~     function in patients at risk who do not have cardiovascular disease and may provide~     information that would guide dietary recommendations. The results may also be used by the~     sponsor to substantiate claims and labeling of their product.~   "
136868|NCT01775735|"~     The primary objective of this study is to evaluate the safety and efficacy of occipital nerve~     stimulation (ONS) using the Boston Scientific Corporation (BSC) Precision™ System in the~     management of intractable chronic migraine, when used in conjunction with anti-migraine~     medications.~   "
136869|NCT01775722|"~     Port wine stain Birthmark is a congenital, progressive vascular malformation of human skin.~     However, even though the pulsed dye laser is considered as the treatment of choice for Port~     wine stain Birthmark the degree of fading can remain variable and unpredictable after laser~     treatment.~   "
136870|NCT01775709|"~     Otitis media is the most common illness in children and 5% to 10% of their symptom cause by~     fluids in their middle ear . The OME can cause hearing loss included poor development of~     speech and poor communication.~      The surgical procedure is considered simple and relatively safe, but several complications~     may occur after Pressure Equalizing tube insertion. The most prevalent complications are~     otorrhea, biofilm and formation of retraction pockets. Otorrhea occurs in 30% to 83% of~     children with tube and is mainly due bacterial contamination of the middle ear either from~     external ear canal or impaired Eustachian tube. Swimming can facilitate the entry of bacteria~     into the middle ear from the ear canal through the PE tubes, and this assumption is~     reinforced by the statistically significant association between the rate of otorrhea and the~     non-utilization of ear plugs in children who swim (from 47% in children who used ear plugs to~     56% in those who did not).~   "
136871|NCT01775696|"~     The main objective of this study is to investigate the central and peripheral inflammatory,~     as well as the spontaneous Aβ-specific, immune responses at the asymptomatic stage and early~     stages of AD by combining molecular imaging techniques with blood biomarker analyses. The~     early and preclinical stages of AD will be studied in the relatives of patients with PSEN1,~     PSEN2 or APP mutations that are at-risk (50%) to be mutation carriers. This study will~     evaluate the contribution of Inflammatory and immune anti-Aβ responses (I2ARs) in AD~     progression. Inclusion of sporadic and familial forms of AD will aid in studying the~     chronology of pathological events. Clinical follow-ups will be conducted annually for two~     years and will include an MRI and a blood draw on the last visit. We expect I2ARs to appear~     in the early stages of the disease and to constitute new prognostic factors. I2ARs could also~     become therapeutic markers for the assessment of novel anti-amyloid treatments and may offer~     new insights to the development of Aβ-specific immunotherapy strategies.~   "
136872|NCT01775683|"~     Homeless men and women suffer more illness and sooner death compared to housed people. Among~     the homeless, there is a group that suffers more illness than others. This group is usually~     homeless for several months, makes up a smaller proportion of homeless people and uses more~     resources from emergency shelters than other homeless people. Some have asked if a difference~     in thinking skills explains how people who are homeless for a long time need more help in~     getting and keeping housing compared to other homeless persons.~      In this study, thinking skills that help a person plan and make decisions will be screened~     among those who have been homeless for a long time and those who were homeless for a short~     time. If there is a difference, then screening may change how future homeless people get the~     help they need.~   "
136873|NCT01775670|"~     The specific aim is to compare the effectiveness of Off-the-Shelf splints and splints~     provided by Occupational Therapy for treatment of trapeziometacarpal (TMC) arthrosis.~   "
136874|NCT01775657|"~     This study will evaluate the impact of continuous, digital pulmonary air leak monitoring on~     the duration of pleural drainage after lung resection in patients with and without a~     pulmonary air leak on postoperative day 1.~      Patients undergoing pulmonary resection who fit the inclusion criteria will be identified~     pre-operatively. Patients within two groups (air leak and no air leak) will be randomized to~     receive either the analogue system or the digital system. Both systems are approved for use~     in hospitals by Health Canada. There will be 88 patients in each air leak group.~      Hypothesis: Continuous, quantitative monitoring of PAL following lung resection leads to an~     improvement in primary outcomes.~   "
136875|NCT01775644|"~     This observational multicenter study will evaluate the differences in progression-free~     survival defined in specific subgroups of participants with metastatic colorectal cancer~     receiving bevacizumab (Avastin). Further, safety and efficacy in daily routine will be~     assessed.~   "
136876|NCT01775631|"~     The purpose of the study is to determine the safety, tolerability and maximum tolerated dose~     of Urelumab in combination with Rituximab in patients with B-cell Non-Hodgkins Lymphoma~   "
136889|NCT01775462|"~     This Phase 2 first-in-neonate EDI200 study will enroll treatment-naïve, XLHED-affected male~     newborns in the first two weeks of life. All subjects will meet entry criteria including~     documentation of an Ectodysplasin (EDA) mutation associated with XLHED. Following Baseline~     evaluations, EDI200 dosing will be initiated between day-of-life 2 and 14, with each study~     subject receiving 2 doses/week for a total of 5 doses. The study will enroll subjects in two~     cohorts with subjects in cohort 1 dosed at 3 mg/kg/dose, associated with partial efficacy,~     and cohort 2 dosed at 10 mg/kg/dose where enhanced efficacy was demonstrated in the most~     relevant preclinical model. Given the challenge of identifying families where the subject is~     yet to be born, it is expected that cohort size and time for recruitment will be variable.~   "
136901|NCT01775306|"~     The aim of this study is to find out if data can be provided by external sensor technology~     which is suitable for controlling the therapy of patients with cardiac recompensation.~   "
137459|NCT01768013|"~     The pharmacokinetics of LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate) in~     Japanese subjects with extensive psoriasis vulgaris.~   "
136877|NCT01775618|"~     Hemophilia A is an inherited blood disorder in which one protein, Factor VIII, needed to form~     blood clots is missing or not present in sufficient levels. Hemophilia A causes the clotting~     process to be slowed and the person experiences bleeds causing serious problems that could~     lead to disability. The current standard treatment for severe hemophilia A is infusion of~     FVIII to stop bleeding, or regular scheduled treatment to prevent bleeds from occuring. Due~     to the short half-life of FVIII, prophylaxis may require treatment as often as every other~     day.~      In this trial safety and efficacy of a long-acting recombinant Factor VIII molecule is being~     evaluated in 50 male subjects, < 12 years of age, with severe Hemophilia A. These subjects~     will receive open label treatment with long-acting rFVIII for approximately 6 months (or~     longer until 50 exposure days) on a regular schedule at least once every 7-days. Doses and~     dose intervals may be adapted to the subject's clinical need. A second group of patients will~     receive open label treatment with the same drug for 12 weeks on a regular schedule of~     2x/week. Patients will attend the treatment center for routine blood samples and will be~     required to keep an electronic diary.~      Subjects will be offered participation in an optional extension study to collect observations~     for at least an additional 50 exposure days.~   "
136878|NCT01775605|"~     Local infiltration with lidocaine prior to epidural placement for cesarean section, although~     brief, can be painful. This pain can lead to increased anxiety and distress, adversely~     affecting patient's overall experience. This study proposes to examine the application of~     Synera pain patch prior to lidocaine infiltration to reduce this pain and anxiety.~      The primary objective of this study is to determine the effect of the Synera on maternal~     experience during epidural placement. The efficacy of Synera pain patch in reducing subject~     pain during skin infiltration with lidocaine prior to epidural placement in subjects~     presenting for scheduled cesarean section will be assessed.~   "
136879|NCT01775592|"~     Resistance of Plasmodium falciparum toward Artemisinins, the most important drug for the~     successful treatment of malaria, has been confirmed in Cambodia. There are few reports from~     neighbouring countries about delayed parasite rates. The investigators therefore aim to~     assess parasite clearance in malaria patients in central Vietnam when treated according to~     national standard guidelines.~   "
136880|NCT01775579|"~     We investigate the potential pharmacokinetic drug-drug interaction between metformin extended~     release and rosuvastatin in healthy male volunteers who receive metformin extended release~     alone, rosuvastatin alone, and both together in a 3 period repeatedly.~   "
136881|NCT01775566|"~     The purpose of this study is to Evaluate and Compare Safety and Pharmacokinetic of the~     Eperisone HCl SR and Myonal in healthy Korean male adults.~   "
136882|NCT01775553|"~     The purpose of this study is to determine the safety and activity of the investigational drug~     known as carfilzomib in the treatment of multiple myeloma (MM) when it is given at doses~     above the usual dose after the standard dosing has become ineffective. The other purpose of~     this study is to understand what causes the multiple myeloma to become resistant to~     carfilzomib and whether this can be overcome in the laboratory.~   "
136883|NCT01775540|"~     This study was to evaluate the healing action on the eye surface of the artificial tear~     Systane® ULTRA as compared to two other eyedrops: Maxidex and Saline solution. Dry eye~     disease leads to inflammation of the eye surface and treating dry eyes with artificial tears~     may lead to reduction in this inflammation and improvement of symptoms and signs.~   "
136884|NCT01775527|"~     IgA nephropathy (IgAN) is the most common primary glomerulonephritis in the world and it~     represents an important cause of end-stage kidney failure. This disease was described as a~     distinct entity in 1968 by J Berger and N Hinglais. The aetiology and the pathogenesis remain~     still obscure. Clinical observations and immunisation studies indicate that IgAN represents a~     dysregulation of the immune system, rather than an intrinsic renal abnormality. Twenty years~     ago, some authors proposed the mucosa-bone marrow axis to explain the pathogenesis of the~     disease. Mucosal IgA plasmocytes are displaced and take up residence in systemic sites. The~     unusual characteristics featured by the IgA produced by these cells (charge, size,~     glycosylation) drive their accumulation, deposition and mesangial activation characteristic~     of IgAN.~      Evidence is emerging that altered lymphocyte homing may ultimately explain this aberrant~     localization.~   "
136885|NCT01775514|"~     This non-interventional study will assess the occurrence rate of non-small cell lung cancer,~     colon cancer, breast cancer, gastric cancer and malignant melanoma in Turkey, and the~     diagnostic methods and treatments used. Data will be collected over 36 months.~   "
136886|NCT01775501|"~     This research study is a Phase II clinical trial. Phase II clinical trials test the~     effectiveness of an investigational combination of drugs to learn whether the drug~     combination works in treating a specific cancer. Investigational means that the modified~     FOLFOX and sorafenib combination is still being studied and that research doctors are trying~     find out more about it-such as the safest dose to use, the side effects it may cause, and if~     the combination is effective for treating different types of cancer. It also means that the~     FDA has not yet approved the modified FOLFOX and sorafenib combination that will be used in~     this study for liver cancer.~      FOLFOX is a combination of three drugs: folinic acid (leucovorin), fluorouracil (5-FU), and~     oxaliplatin. The dosage amounts for some of these FDA approved drugs will be modified~     slightly in this study. The FOLFOX combination is approved by the FDA and is a standard~     treatment of colorectal cancer. However, it is not approved for the treatment of liver~     cancer.~      Sorafenib is a new drug, which is approved under the brand name Nexavar for the treatment of~     liver cancer. It is also currently being tested in various other cancers. Sorafenib works by~     slowing down and/or stopping the development of new cancer cells and new blood vessels. By~     slowing down and/or stopping the growth of new blood vessels around a tumor, it is believed~     that sorafenib prevents or slows down the growth of tumors.~      In this research study, sorafenib, the standard treatment, is being combined with modified~     FOLFOX, which has shown some antitumor activity in liver cancer.~   "
136887|NCT01775488|"~     The HistoSonics' Histotripsy BPH Device, the Vortx Rx, is a portable ultrasound therapy~     device. The purpose of this study is to assess and monitor the performance of the Vortx Rx~     for initial safety and efficacy for the treatment of Benign Prostatic Hyperplasia.~   "
137506|NCT01767402|"~     The purpose of this study is to examine the safety, reactogenicity and immunogenicity of the~     GlaxoSmithKline (GSK) Biologicals candidate pneumococcal vaccine containing PhtD in healthy~     elderly population aged 18-45 years of age.~   "
136890|NCT01775449|"~     Use lay language. Oxaliplatin is a reference anticancer drug in the treatment of colorectal~     cancer. However, its use is hampered by a specific neurotoxicity, which is characterized by~     acute thermal hypersensitivity, notably to cold temperatures, and by chronic neuropathy~     appearing with the repetition of chemotherapy cycles.~      To this date there is no effective therapy able to prevent and/or to treat these adverse drug~     reactions. So oncologists are sometimes strained to decrease anticancer doses or to stop~     chemotherapy; Previously, a polyamine deficient diet has been able to prevent acute~     oxaliplatin-induced hypersensitivity in animals.~      So we hypothesizes that a specific nutritional therapy, a polyamine deprived diet, may~     prevent acute oxaliplatin-induced hypersensitivity in patients.~   "
136891|NCT01775436|"~     Our goal is to advance palliative care with persons living with AIDS (PLWA) or life-limiting~     co-morbidities to decrease suffering and increase quality of life (QOL). Left without advance~     care planning (ACP) for end-of-life decision, miscommunication and disagreements may result~     in families being charged with neglect or court battles over treatment choices, unmet care or~     delivery of unnecessary or unwanted care, and non-relative caregivers being dismissed (e.g.~     gay partners). We hope to increase families' understandings of their family member's wishes~     for end-of-life care to decrease conflict through the FAmily-CEntered Advance (FACE) Care~     Planning intervention. We will also study communication, quality of life, and spiritual~     struggle. Families will be randomized into either the Control (N=96 families) or the FACE~     Intervention (n=192 dyads). FACE families will meet with a trained/certified researcher for~     two 60-minute sessions scheduled one week apart: Session 1: The Respecting Choices~     Interview®; and Session 2: Completion of The Five Wishes©. Control families will also meet~     with a researcher for two 60-minute sessions scheduled one week apart: Session 1:~     Developmental History; and Session 2: Nutrition and Exercise. Questionnaires will be~     administered five times, Baseline and at 3, 6, 12 and 18 month post-intervention, for an~     average of 2 years.~      AIM 1. To determine the efficacy of FACE on congruence in treatment preferences between PLWA~     and their surrogates over time, and the effect of the pattern of congruence development~     trajectory on healthcare utilization (i.e., distal outcomes: number of hospitalizations,~     dialysis, ER visits).~      Hypothesis A: Development of congruence may not be homogeneous and FACE may influence the~     pattern of congruence development.~      Hypothesis B: Different patterns of congruence development may have different effects on~     health care utilization.~      Hypothesis C: Compared to Controls, FACE participants will better maintain congruence over~     time.~      AIM 2. To determine the efficacy of FACE on key components of QOL for PLWA. Hypothesis: FACE~     participants will increase or better maintain psychosocial QOL compared to Controls.~      AIM 3. To minimize health disparities in ACP between Blacks and non Blacks and identify~     factors associated with disparities.~      Hypothesis: Blacks in the FACE intervention will complete advance directives at a rate~     comparable to non Blacks, and at significantly greater rates compared to Controls.~   "
136892|NCT01775423|"~     This is an open label, single arm, dose escalation study of BBI608 in patients with advanced~     malignancies.~   "
136893|NCT01775410|"~     This is a prospective, multi-center, non-randomized single arm feasibility trial of the~     Wolverine OCT guided atherectomy system.The trial will enroll up to 50 subjects diagnosed~     with peripheral vascular disease of the lower extremities.The primary disease must be located~     in reference vessel diameters ≥ 2.5 mm which is significant enough to cause moderate to~     severe symptoms and warrant vascular intervention.~   "
136894|NCT01775397|"~     The primary objective is to compare fidaxomicin versus vancomycin for the sustained clinical~     cure of Clostridium difficile Infection (CDI) in adult patients receiving immunosuppressive~     therapy.~   "
136895|NCT01775384|"~     Nutrasorb is a newly developed food product (see www.nutrasorb.com). This study will use the~     Nutrasorb soy protein product that is matrixed with polyphenols from blueberries and green~     tea extract, and test for efficacy as a nutritional countermeasure to exercise-induced~     physiologic stress (i.e., immune dysfunction, inflammation, and oxidative stress) using both~     traditional and metabolomics-based outcome measures.~   "
136896|NCT01775371|"~     Background: Inadequate pain management is common in the Emergency Department (ED). Optimal~     treatment of pain necessitates titration to effective dose due to the large inter-individual~     variability in opioid requirement. However nurse administered titration is difficult to~     provide in this setting due to high patient to nurse and physician ratios and multiple urgent~     competing patient demands. Patient controlled analgesia (PCA) lets ED patients actively~     participate in pain management by allowing self-titration to their desired level of pain~     relief. A tightly controlled randomized clinical trial (RCT) funded by NINR recently~     completed by the investigators group provides promising preliminary support for the efficacy~     and safety of PCA for patients with abdominal pain at a single ED with a dedicated research~     nurse and standard loading dose given to all patients. Objective: The overall objective is to~     provide optimal pain management in the ED. Specific aims: 1)To compare the effectiveness and~     safety of PCA and non-PCA opioid analgesia when nurses involved in clinical care deliver the~     intervention to a broad group of ED patients with acute pain at multiple clinical centers.~     The primary hypothesis is that there will be a greater decline in pain over time and similar~     safety in patients randomized to receive PCA compared to patients receiving standard opioid~     analgesia. 2) To describe the feasibility of PCA in terms of patient and provider acceptance,~     resource utilization and cost associated with PCA. Innovation: PCA represents a novel shift~     from the current provider-driven model of ED pain management to one in which the patient is~     an active participant. Few prior studies have evaluated ED PCA and no systematic evaluation~     of time and resources exists. Methodology: An RCT will be performed at 3 clinical centers.~     750 patients with acute pain warranting IV opioid administration will be randomized to~     receive usual opioid analgesia determined by the provider or PCA (loading dose 0.1 mg/kg~     morphine and demand dose of 1 mg morphine available every 6 minutes). Pain intensity will be~     measured by a numerical rating scale recorded every half hour up to 2 hours after initial~     opioid administration. Primary endpoints are rate of change in pain intensity from 30 minutes~     after initial administration of opioid to 2 hours as suggested by the results of the~     preliminary study and incidence of adverse events. PCA will also be compared to non-PCA~     opioid analgesia assessed at the end of the 2 hour study period by patient satisfaction with~     pain management; RN assessment of time efficiency/ease of use and satisfaction with pain~     management; and physician satisfaction with pain management. Resource utilization and cost~     associated with implementation and use of PCA in the ED setting will be assessed by total RN~     time spent on pain management per patient; pharmacy preparation time per patient; material~     cost per patient and RN and MD training time necessary for PCA implementation. Significance:~     If PCA is demonstrated to be effective, safe, and associated with patient and provider~     acceptance and acceptable resource utilization, it has the potential to significantly improve~     ED pain management.~   "
136897|NCT01775358|"~     The primary objective of this study is to evaluate the safety and tolerability of a single~     dose of ALRN-5281 administered by subcutaneous injection to healthy adult volunteers.~   "
136898|NCT01775345|"~     To determine that rehabilitation treatment for a partial meniscectomy is more efficient in~     the functional recovery of the knee. Set in the fewest possible sessions, what treatment has~     benefits that last beyond the physical and what is the best cost-effectiveness.~      It is expected that the combination of isotonic and isokinetic exercises in post-meniscectomy~     physiotherapy allows faster and less costly patient rehabilitate than the current isotonic~     protocol.~   "
136899|NCT01775332|"~     The purpose of this research study is to determine the utility of educational materials~     designed to inform patients of their pituitary condition, in an effort to assist the~     patients, families, and staff deal with pituitary tumours and related conditions in the best~     way possible. We have developed a website, informational videos, and a brochure for pituitary~     tumour patients and their families. The primary outcome measures will be 1) the level of~     knowledge that patients have of their condition before and after reviewing the materials~     provided; and 2) ease of use and user satisfaction of the materials. We hypothesize that our~     informative multimedia educational package will not only improve the health literacy and~     self-efficacy of patients and their families, but will also improve quality of care.~   "
137526|NCT01767142|"~     Evaluate the safety and feasibility of non-invasive fat reduction in the outer thigh with a~     belt applicator. Applicator design and treatment parameters will be evaluated.~   "
136902|NCT01775293|"~     The aim of this study is to evaluate the efficacy and safety of the investigational device,~     RPM,non-absorbable polypropylene mesh made by D Med, in correction of Nasolabial fold.~      Study hypothesis~        -  level of significance: alpha=0.05( two-side)~        -  power of test: (power= 1-beta),power=0.08~        -  H0: P equals P0~        -  H1: P unequals P0~        -  The difference between the changes in the WSRS(Wrinkle Severity Rating Scale) of the pre~          and post rhytidectomy from baseline at 7week after administration is 0.237( P-P0= 0.237)~   "
136903|NCT01775280|"~     The study enrolls patients with non-resectable or borderline resectable hepatocellular~     carcinoma (HCC), intraheaptic choalngiocarcinoma (IHCC) or colorectal cancer metastasis.~     Patients are not a candidates for liver transplantation and have only limited extrahepatic~     disease. All patients are treated with radioembolization. Primary endpoint is the percentage~     of patients that can be downstaged to resectability.~      Secondary endpoints are radiologic response to radioembolization,tissue response to~     radiomembolization and systemic immune response and intra-tumoral T-cell response to~     radioembolization.~        -  Trial with radiotherapy~   "
136904|NCT01775267|"~     This randomized phase II trial compares how well associating liver partition with portal vein~     ligation for staged hepatectomy (ALPPS) or portal vein occlusion (PVO) works in treating~     patients with liver cancer. Both treatments are types of 2-stage hepatectomies for removing~     liver cancer. ALPPS may be more effective than PVO in patients whose disease would~     traditionally be considered inoperable.~        -  Trial with surgical intervention~   "
136905|NCT01775254|"~     The overall purpose of this study is to describe the trajectory of early survivorship in~     individuals with colon cancer who undergo both surgical and medical management of colon~     cancer. The primary question is whether or not there is an interaction between type of~     surgery and changes in quality of life, sexual function, peripheral neuropathy, and demands~     of illness following curative resection and adjuvant chemotherapy.~   "
136906|NCT01775241|"~     It is the objective of this study to collect scientific data of sleep apnoea syndrome~     patients´ cardiac and respiratory function by additional sensors.~   "
136907|NCT01775228|"~     Recovery from coronary artery bypass graft (CABG) surgery is a complex process involving~     physical recuperation and psychological adjustment. The high prevalence of postoperative~     depression in this population may threaten optimal recovery. Peer support over the recovery~     period has promise to mitigate this threat. The purpose of this study was to examine the~     effect of a professionally-guided telephone peer support intervention on recovery outcomes~     including depression, social support and health care resource utilization.~      In a randomized controlled trial, 185 male CABG surgery patients randomly assigned to an~     intervention (n=61) or usual care (n=124) group. Participants in the intervention group~     received weekly telephone calls from a peer volunteer over 6 weeks post discharge. At~     hospital discharge and at 6 and 12 weeks follow up, depression was measured using the Beck~     Depression Scale-II, social support was measured using the Shortened Social Support Scale and~     health care resource utilization was measured using items in the Postoperative Self Report of~     Recovery Questionnaire. Participants in the intervention group were also asked questions~     about their perceptions regarding peer support using the Peer Support Evaluation Inventory.~   "
136908|NCT01775215|"~     In patients with aortic stenosis the valve through which blood is pumped out of the main~     heart chamber is narrowed. This results in heart muscle working harder to open the valve so~     blood can circulate around the body. The muscle adapts to the increased pressure load to~     maintain efficiency. This can cause long-term muscle damage. To predict when this~     deterioration will require a valve replacement is difficult and untimely operation exposes~     patients to unnecessary risk.~      We aim to compare all validated techniques looking at different aspects of heart muscle~     strain in these patients. These will be a blood sample measuring a specific hormone (BNP) and~     enzyme (Troponin), a nuclear scan to assess nerve activation, an MRI identifying scarring and~     an exercise echocardiogram that measures heart muscle response and pressure changes across~     the valve. Tests will be performed at recruitment and either after one year or after valve~     replacement, which ever comes first.~      In comparing these different imaging techniques we aim to identify patients who will benefit~     from an early operation, those whose muscle is likely to recover back to normal and which~     patients it is safe to wait longer for the surgery, avoiding unnecessary risk.~      The results of the study will benefit patients as it will help doctors more accurately assess~     the timing of valve surgery and improve their prediction of long term heart muscle recovery.~     It may also increase convenience in clinical management by reducing unnecessary tests and~     hospital trips. This would translate into cost savings for the NHS.~   "
136909|NCT01775202|"~     This descriptive study aims to evalaute in a retrospective way the incidence of cogntive~     changes postoperatively after fast-track colon surgery at Hvidovre Hospital. This survey is~     based on chart reviews.~   "
136910|NCT01775189|"~     The main purpose of this study is to determine if oxycodone and naltrexone combination~     capsules (ALO-02) have the potential to be abused when they are crushed and snorted.~   "
136911|NCT01775176|"~     The purpose of the study is to test in 52 overweight and obese women with polycystic ovary~     syndrome the effect of 6 months of treatment with either: exercise training, 25% dietary~     restriction or metformin in comparison to a control group receiving no intervention on the~     functions of the skeletal muscle and adipose tissue.~   "
136912|NCT01775163|"~     The E-MECHANIC Ancillary Study will measure changes in 24-hour energy expenditure and~     spontaneous physical activity in a subset of 60 obese individuals enrolled in the main study.~     We aim to determine if changes in energy metabolism might explain why people don't lose the~     expected amount of weight in an exercise program.~   "
136913|NCT01775150|"~     We plan to integrate WHO educational material using mobile phone text messaging, target on~     pregnant women in remote rural areas in China. We hypothsized that text messaging can have~     major impact on reducing maternal and infant deaths in rural China because text messaging is~     accessible, acceptable, and affordable.~   "
136914|NCT01775137|"~     The purpose of this extension study is to collect additional 48 weeks of safety data from~     patients taking TIP who have completed the core study CTBM100C2401. The purpose of collecting~     second year safety data through this study is to obtain long-term (2 years) safety data of~     TIP.~   "
136916|NCT01775111|"~     The aim of this randomized, observer-blind, controlled intervention study with parallel~     groups is to study the effect of strength training (2x/week for 6 months) with and without~     additional dietary supplementation (protein-enriched) on muscle strength, function and mass,~     oxidative stress parameters and the immune system in elderly institutionalized persons.~      The participants (n = 120) are recruited from Viennese senior residencies (Kuratorium Wiener~     Pensionistenwohnheime). After a pre-participation screening participants will be distributed~     randomly but stratified by sex and age to one of the 3 intervention groups (cognitive~     training, strength training, strength training + supplement).~      Study participants are eligible if they are male or female with an age over 65 years and if~     their cognitive status as well as their physical fitness level allows to participate at the~     strength training sessions. Exclusion criteria comprise chronic diseases which contraindicate~     the medical training therapy, serious cardiovascular disease, diabetic retinopathy and~     manifest osteoporosis, medication with anticoagulants or cortisone drugs and also regular~     strength training during the last six months.~      Primary outcome measure is the change in isokinetic torque of knee extensors. Secondary~     outcome measures comprise anthropometric data, functional performance tests, immunological~     and oxidative stress parameters. The change in muscle signaling pathways will be assessed~     from muscle biopsies.~   "
136917|NCT01775098|"~     The objectives of the present study are to determine if starting treatement of hyperuricemia~     with allopurinol during an acute gout crises has an impact on the duration or the severity of~     the crises~   "
136918|NCT01775085|"~     The purpose of this study is to compare two types of groups for breast cancer survivors: a~     Meaning-Centered Group and a Discussion Group. Many breast cancer survivors seek help to deal~     with the emotional burden of having gone through the cancer experience. Participation in~     groups offering support often helps cancer survivors cope with stressors of life after having~     had cancer by giving them a place to express their feelings. The Meaning-Centered Group is~     intended to teach breast cancer survivors how to maintain or even increase a sense of meaning~     and purpose in their lives after treatment for cancer. The Discussion Group is intended to~     help breast cancer survivors cope by giving them a place to get support from other breast~     cancer survivors.~      The goal of this study is to compare the benefits of these two types of group approaches for~     breast cancer survivors. The study is also testing the benefits and feasibility of conducting~     the groups virtually using a telephone and computer.~   "
136919|NCT01775072|"~     The purpose of this study is to determine whether certain genes in cancer may be abnormal.~     When a gene is abnormal this is called a mutation. Most mutations in cancer cells are not~     inherited (passed down from parents) but happen after birth in the cancer itself. Most~     cancers have many mutations. Some of these mutations are important for the cancer cells to~     survive while others are not. The goal of this study is test cancer for certain mutations~     using leftover tumor tissue from a previous surgery or biopsy. Participants will also be~     asked to provide a tube of blood cheek (also known as a buccal) swab, or a saliva sample that~     contains normal genes for comparison.~      The purpose of Part B of this study is to:~      Understand how genetic changes in tumor effect the chance of responding to experimental~     cancer treatment. Understand how the genes in the tumor change overtime in response to~     targeted cancer treatment.~   "
136920|NCT01775059|"~     This is a multi-center, non-randomized, and interventional study in which subjects will use~     the Integrated sensor and infusion set with MiniLink Transmitter and the Medtronic Paradigm®~     VEO™ insulin pump (Sensor augmented pump) for 15 days.~      The purpose of this study is to collect performance data on the Integrated sensor and~     infusion set for approximately 15 days, with the intention for each subject to wear 5 sets~     for 3 days each.~   "
136921|NCT01775046|"~     The objective of this study is to assess the benefits of endovascular technique in terms of~     efficacy and safety of Valiant Thoracic Stent Graft with the Captivia Delivery System in the~     treatment of thoracic aortic disease, in a cohort of patients representative of the~     population treated under real-life conditions of use in France for up to 5 years.~   "
136922|NCT01775033|"~     The overall goal of this project is to develop and evaluate an organized, regional system of~     pediatric emergency care in rural western Pennsylvania.~   "
136923|NCT01775020|"~     Pilot data in patients and data from pig studies indicate that arginine-NO metabolism is~     impaired in sepsis with changes in splanchnic metabolism and function, and reduced survival~     at low nitrate levels. Prolonged intravenous supplementation of L-arginine proved effective~     in pigs for increasing NO production, restoring gut function, and inhibiting an increase in~     pulmonary arterial pressure, without any deleterious systemic side effects. Prolonged~     intravenous L-arginine supplementation could therefore be useful in septic ICU patients.~   "
136924|NCT01775007|"~     A Brillouin ocular analyzer uses a low-power near infrared laser light to probe the~     viscoelastic properties of the cornea and crystalline lens in the eye. The study hypothesis~     is that the instrument can measure the Brillouin light scattering spectra from the eye safely~     and effectively from human subjects.~   "
136925|NCT01774994|"~     Investigation of arginine and NO metabolism in healthy subjects is important as a reference~     for alterations in arginine-NO metabolism in patients. Moreover, this study will indicate the~     changes during aging and gender-related differences. Although data on arginine metabolism~     exist in literature, data are limited to young healthy male subjects. Since patients with~     suspected changes in arginine metabolism, e.g. sepsis and cancer patients are often elderly~     and also women, knowledge of arginine metabolism in these groups is needed.~   "
136926|NCT01774981|"~     The purpose of this two-part study is to investigate the safety, tolerability and efficacy of~     LY3016859 after multiple intravenous (IV) dosing's in participants with diabetic nephropathy~     (DN). Part A will be dose escalation for safety and tolerability and Part B will evaluate~     Proteinuria.~   "
136927|NCT01774968|"~     The main purpose of this study is to compare the effectiveness of Human Regular U-500 Insulin~     three times a day versus twice a day.~   "
137006|NCT01773928|"~     The purpose of this study is to determine if a Vero cell-derived trivalent seasonal influenza~     vaccine produced by the modified manufacturing process:~        1. induces immune responses comparable to that produced by the current manufacturing~          process~        2. has an acceptable safety profile compared to a licensed trivalent seasonal influenza~          vaccine~        3. demonstrates consistency of immune response among three different lots.~   "
136928|NCT01774955|"~     This is a multicenter, prospective, observational investigation, focusing of antiplatelet~     treatment in patients with moderate to high risk acute coronary syndrome (TIMI risk score~     ≥3)subjected to percutaneous coronary intervention (PCI), being conducted in 7 PCI capable~     hospitals in Greece. Data concerning patients' demographic, clinical/procedural~     characteristics and contraindications/special warnings and precautions to P2Y12 inhibitors~     are collected during initial hospitalization. Study involves 3 follow-up visits after~     hospital discharge(Day 30, at 6 months and at 12 months) where data on major adverse cardiac~     events (death, myocardial infarction, stroke, urgent revascularization procedure with PCI or~     CABG), bleeding events(according to Bleeding Academic Research Consortium criteria)and~     adherence to antiplatelet treatment are collected.~      In patients under ticagrelor or prasugrel treatment, platelet reactivity measurement with~     VerifyNow assay will be performed at Day 30~   "
136929|NCT01774942|"~     Gum disease and type 2 diabetes are common chronic diseases that affect each other. Diabetes~     is increasing, especially in Pakistan. People with diabetes have a greater risk for gum~     disease. Also, it is thought that that gum disease, a chronic infection, can be a source of~     systemic inflammation and may contribute to poorer diabetes control.~      The aims of this project are to study:~        1. Changes in sugar control in people with type 2 diabetes and severe gum disease after~          having all teeth removed and replaced with Straumann dental implants and full dentures~        2. Changes in certain inflammation markers seen with insulin resistance and other diseases~          and conditions more common in people with diabetes~        3. Retention of dental implants in people with type 2 diabetes.~      The study will recruit 30 patients with type 2 diabetes and severe gum disease from Dr. Amin~     Rahman's private practices in Pakistan. Their long-term sugar (HbA1c) must be 7.5% or more~     and the inflammatory marker, C-reactive protein (hsCRP) 1mg/dL or more. Consenting~     participants will first have an oral examination. Eligible patients will have impressions of~     the jaws and the color of their teeth and gums recorded. At the next visit, all teeth will be~     extracted and dentures provided. One week later, there will be a check-up visit. Three months~     after the teeth were removed, Straumann dental implants will be placed in the jaws. After one~     week, the patient will be checked again. After three months, the dentures will be adjusted to~     fit the implants. Follow-up visits will occur every three months until one year after the~     implants were placed, then every six months for the next five years, to check the health of~     the patients as well as their implants, the gums around them, and the dentures. Blood samples~     will be taken at each follow-up visit.~      Our hypotheses are that levels of HbA1c and hsCRP will:~        1. decrease after extraction of all teeth~        2. not increase after placement of dental implants~        3. not increase after prosthetic restoration with full dentures anchored on the dental~          implants.~   "
136930|NCT01774929|"~     The purpose of this study is to evaluate the efficacy and safety of Transdermal Therapeutic~     System (TTS)-fentanyl patch (transdermal patch containing a drug that is put on the skin so~     the drug will enter the body through the skin) in participants with moderate (medium level of~     seriousness) to severe (very serious, life threatening) pain of osteoarthritis (disorder,~     which is seen mostly in older persons, in which the joints become painful and stiff).~   "
136931|NCT01774916|"~     Cutaneous Arteriovenous malformations (AVM's) rare congenital high-flow vascular~     malformations in which arteries and veins are directly connected through a complex web of~     abnormal arteries and veins instead of a normal capillary network. Arterial feeders and~     enlarged draining veins directly connect through arteriovenous fistulas that create the~     nidus. The natural history of AVMs is organized into a clinical staging system: during the~     first phase of quiescence, the arteriovenous malformation mimics a capillary malformation.~     After many years, the AVM may enlarge with loco-regional expansion and tissular destruction.~     At the ultimate stage, AVM may impact the heart function. They are considered non malignant~     but can expand and become a significant clinical risk when extensive. The management of these~     high flow AVM remains often problematic. Complete and large surgical excision of the nidus~     after hyperselective embolization is the only potential therapeutic solution but this, is~     often difficult if not impossible. There is no pathogenetic hypothesis for the development of~     these malformations. Histopathological examination (performed only on surgical resection~     specimen) is poor and does not provide sufficient evidence to assess the evolutivity or the~     severity of the MAV. Recent data hypothesize that these vascular malformations are associated~     with alterations of the vascular endothelium caused by genetic abnormalities involved in the~     control of angiogenesis and vascular homeostasis. The detection of these anomalies allows the~     search for cellular and genetic markers that might be useful to optimize the clinical~     classification, staging, predicting the evolution of these defects and some understanding of~     its pathophysiological mechanisms. To our knowledge, no studies to identify cellular markers~     / genetic and endothelial associated with the development of cutaneous AVMs have been~     published to date.~   "
136932|NCT01774903|"~     The purpose of this study is to evaluate the efficacy and safety of Transdermal Therapeutic~     System (TTS)-fentanyl patch (transdermal patch containing a drug that is put on the skin so~     the drug will enter the body through the skin) in severe (very serious, life threatening)~     chronic (lasting a long time) low back pain in Thai participants.~   "
136933|NCT01774890|"~     The remarkable improvement in survival of children with congenital disease has led to a~     continuously growing number of adults with congenital heart disease in the developed world.~     Many of these patients had had cardiac surgery at early age, the may live for many years with~     pressure overload, volume overload, systolic or diastolic dysfunction, cyanosis or any~     combination of the above. These past and ongoing cardiac insults often result in significant~     cardiac remodeling. A biomarker for fibrosis and remodeling may have enormous clinical and~     prognostic value for these patients.~      Serum biomarkers are now integrated in many fields in medicine. In cardiology, a number of~     biomarkers are used. In the last decade, our group has focused on the natriuretic peptides as~     markers for heart disease in infants and children. This resulted in many studies and more~     than 25 publications in the medical literature. We believe that the newly discovered cardiac~     marker, ST2, will emerge as an important addition to cardiac evaluation in the coming~     years.The aim of this study is to measure ST2 levels in patients with congenital right heart~     disease and correlate ST2 levels to clinical status, imaging and prognosis.~   "
136934|NCT01774877|"~     Bi Syndrome is one of Traditional Chinese Medicine（TCM）name, It means an obstruction in~     Chinese,and it refers the syndrome characterized by the obstruction of qi and blood in the~     meridians due to the invasion of external pathogenic wind,cold and dampness, manifested as~     soreness, pain, numb,etc. Bi Syndrome contains Rheumatoid arthritis(RA). RA is a chronic~     disease affecting more than 20 million people in the world.It is one of the most common forms~     of autoimmune disease. Xin'an Medicine is one of Traditional Chinese Medicine which~     originated from AnHui. Xinfeng Capsule developed according to the Xin'an medicine theory ,and~     it has long been adopted for treatment of rheumatoid arthritis (RA). The study is aimed to~     evaluate the effectiveness and safety of Xinfeng Capsule in the treatment of RA.~   "
136935|NCT01774864|"~     Study Design : multi-center, double-blind, placebo-controlled, randomized,~      parallel group, fixed dose design~      Phase : Phase III~   "
136936|NCT01774851|"~     To determine whether the combination of MM-111 plus paclitaxel and trastuzumab is more~     effective than paclitaxel and trastuzumab alone~   "
136937|NCT01774838|"~     To test the vasoactive and anti-inflammatory effects of prasugrel in patients with acute~     coronary syndrome endothelial function -as a surrogate parameter of NO bioavailability- and~     different markers of inflammation, oxidative stress and platelet activation will be assessed~     in patients with unstable angina.~   "
136939|NCT01774812|"~     Despite advances in treatment of conventional cardiovascular risk factors, patients with~     kidney disease remain at high risk for fatal cardiac events. To date, kidney disease affects~     approximately 2 million Canadians; however, this patient population remains grossly~     understudied due to the complex nature of the disease. The inadequacy of the literature to~     address the cardiovascular-related mortality rates in those with kidney disease reflects the~     urgent need for investigation of novel risk factors.~      One cardiovascular risk factor which has recently been validated is the clinical measurement~     of cardiac autonomic tone (CAT). CAT refers to the amount of activity contributed by the~     stimulatory and inhibitory limbs of the cardiac autonomic nervous system, which work in~     concert with one another to control heart rate. CAT can be quantified computer analysis of~     heart rate over time, captured by a simple Holter electrocardiogram (ECG) recording. Abnormal~     CAT, which occurs when the autonomic system does not control heart rate properly in response~     to physical demands or stress, is associated with risk of adverse cardiovascular events in~     both healthy and high risk populations. It has recently been shown that patients with severe~     kidney disease demonstrate significant CAT abnormalities, thus exaggerated susceptibility to~     cardiac death.~      Vitamin D (VD) deficiency is also common in this patient population due to the fact that the~     kidney plays a crucial role in VD metabolism. Given that VD deficiency is an established~     cardiovascular risk factor on its own, it is possible that kidney disease patients~     experienced compounded risk due to the combination of VD deficiency and abnormal CAT.~     However, no study has ever investigated whether VD deficiency influences CAT in healthy or~     diseased populations. To our knowledge, this will be the first trial to ever examine the~     effect, if any, of different VD supplementation treatments (standard of care vs. combination)~     on CAT in a population burdened with overwhelming risk and incidence of cardiovascular and~     sudden cardiac death risk.~   "
136940|NCT01774799|"~     This is a 5-year cluster RCT of a video Advance Care Planning intervention vs. control among~     360 nursing home residents with advanced dementia (N=180/arm) in 20 matched nursing homes (10~     intervention/10 control). Clinical outcomes will be collected at baseline, and quarterly (up~     to 12-months) regarding goals of care preferences, advance care planning, and treatments~     received. The primary outcome is decisions not to be hospitalized at 6 months.~   "
136941|NCT01774786|"~     This double-blind, placebo-controlled, randomized, multicenter, international, parallel arm~     study will evaluate the efficacy and safety of pertuzumab in combination with trastuzumab,~     fluoropyrimidine and cisplatin as first-line treatment in participants with HER2-positive~     metastatic gastroesophageal junction (GEJ) or gastric cancer (GC). Participants will be~     randomized to receive pertuzumab 840 milligrams (mg) or placebo intravenously every 3 weeks~     (q3w) in combination with trastuzumab (initial dose of 8 milligrams per kilogram [mg/kg]~     intravenously [IV] followed by 6 mg/kg IV q3w) and cisplatin and fluoropyrimidine~     (capecitabine or 5-fluorouracil) for the first 6 treatment cycles. Participants will continue~     to receive pertuzumab or placebo and trastuzumab until disease progression occurrence of~     unacceptable toxicity or withdrawal from the study for another reason.~   "
136942|NCT01774773|"~     E5501 (5 mg, 20 mg, and 40 mg) will be administered to healthy male adults in a~     single-center, randomized, open-label, cross-over manner. This study will consist of 2 phases~     including pre-randomization (before drug administration) and postrandomization (after drug~     administration).~   "
136943|NCT01774760|"~     The results of previous studies suggest further development of [18F]EF5 as a PET tracer for~     imaging hypoxia. This is a non-randomized prospective study to obtain information on~     reproducibility of [18F]EF5 intratumor distribution using repeated pretreatment PET/CT scans.~   "
136944|NCT01774747|"~     Double-blind, placebo-controlled, multiple ascending oral dose evaluation of the safety,~     tolerability, and pharmacokinetics of DSP 1053 and its metabolites in healthy subjects and in~     subjects with major depressive disorder~   "
136945|NCT01774734|"~     1. Chronic neck pain is common in general population.~             -  High health care source expenditure~             -  Multiple therapeutic approaches available with limited evidence~             -  Previous studies showed active strengthening exercise improved pain (VAS) and~               functional performance (NDI)~             -  Muscle strengthening exercise with biofeedback technique showed more long-lasting~               effect in patients with chronic neck pain~        2. The investigators hypothesize that daily use of the neck strength exerciser (NSE),~          combined biofeedback technique with muscle strengthening exercise posture adjustment, in~          addition to traditional physiotherapy, could have more long-lasting and prominent effect~          on pain and functional improvement in patients with chronic neck pain.~   "
136946|NCT01774721|"~     This is a multinational, multicenter, randomized, open-labeled, Phase 3 study comparing the~     efficacy and safety of treatment with Dacomitinib (PF-00299804) to treatment with gefitinib~     in patients with locally advanced or metastatic non-small cell lung cancer, with epidermal~     growth factor receptor (EGFR) activating mutation (s). Analyses of primary objective~     (Progression Free Survival) will be done as defined in the protocol.~   "
136947|NCT01774708|"~     Presence/absence in bed along with heartbeat, respiration, and gross motion in bed will be~     measured in 48 Budd Terrace residents, a long-term care facility of Emory Healthcare.~     Measurement will be done using only pressure-sensitive mats that lie underneath the mattress~     and never touch the patient. PHI information will be collected by Emory staff. This PHI will~     be restricted to: age at time of participation; medical conditions; and medications. The PHI~     will be stored in a locked file behind a locked door. Data management will provide a unique~     identifier for each participant linked to a name that will be kept separately from the~     aggregate data.~      The data collected from the bed sensor will be processed offline and separately from the PHI~     to do proof of concept evaluation for the use of machine learning technology to predict bed~     exits 1 to 5 minutes ahead of time.~   "
136948|NCT01774695|"~     Increased physical activity has in the investigators recent study been shown to improve~     symptoms in irritable bowel syndrome (IBS). The aim of this study was to assess the long term~     effects of the investigators previous intervention in IBS patients to improve physical~     activity. The investigators aimed to assess the long term effects on IBS symptoms as well as~     quality of life, fatigue, depression and anxiety.~   "
136949|NCT01774682|"~     The aim of this study is to evaluate the consequences of sleeve gastrectomy on functional~     parameters of patients perambulation.~   "
136984|NCT01774227|"~     -  Transcleral cyclophotocoagulation (TSCPC) has long been used as refractory glaucoma~          management and is very easy to learn and easy to perform.~        -  Recent advances in laser technology; the role of TSCPC is being expanded because it has~          benefits of noninvasive glaucoma procedure.~        -  The titration (pops), the fixed high-energy, and the fixed-low energy (slow-coagulation)~          are three energy delivery techniques.~        -  The present study would report on the outcome (efficacy and safety) of the~          slow-coagulation versus the titration method in treatment of refractory glaucoma with~          dark iris.~        -  The results would provide reliable evidences to supplement clinical judgment when making~          a decision in favor of each treatment method for glaucoma patients.~   "
136950|NCT01774669|"~     The patient study is a phase III trial designed as a single-blinded, randomised, controlled~     multi-centre trial with repeated measurement events (ME). Patients will be evaluated by a~     blinded assessor on five occasions: twice within two weeks at baseline before intervention~     start (BL, T0), once after eight treatment sessions (T1), once after the intervention (T2),~     and once after a two month follow-up period (FU). Figure 1 illustrates the study overview.~      The study focuses on the evaluation of the YouGrabber efficacy compared to conventional~     therapy in an outpatient setting.~      Research question: Do patients after stroke in the YouGrabber training group show higher~     postintervention performance in the Box and Block Test (BBT) compared to patients in the~     conventional therapy group? Hypothesis: H0: The investigators hypothesise that there will be~     no group differences after 16 training sessions or after the two month follow-up period.~      H1: The investigators hypothesise that there will be a group difference after the 16 training~     sessions and after the two month follow-up period.~      Aim: The aim of the project is to design and implement a single-blinded, randomised~     controlled multi-centre trial comparing YouGrabber training and conventional therapy in~     patients after stroke.~      Patients will be randomly allocated to either the experimental group (EG) or the control~     group (CG) after the second ME (T0). Group allocation will be based on a computer-generated~     randomisation list (one for each centre, (MATLAB, 2007b, Mathworks Inc., USA) created by a~     researcher not involved into the study. Randomisation lists and corresponding token will be~     stored in the clinics' pharmacy. Patients will draw a token before the first therapy session.~     The token will be marked and stored until study finalisation in the pharmacy.~      Group allocation will remain concealed for the independent assessor until study finalisation.~     Patients and treating therapists will be reminded not to talk about patient's group~     allocation with other therapists or participants.~      Patients in both study groups (EG, CG) will receive the same amount of 16 sessions lasting~     for 45 minutes each. During each therapy appointment patients can decide to stop the training~     at any time.~      Patients allocated to EG will have the opportunity to participate in two semi-structured~     interviews to evaluate their expectations and experiences with the virtual reality therapy~     with YouGrabber.~      Treating therapists will have the opportunity to participate in one focus group meeting to~     evaluate their experiences with the virtual reality training, its advantages and~     disadvantages. Interview and focus group participation will be voluntary.~   "
136951|NCT01774656|"~     The purpose of this study is to determine the proportion of subjects who have sufficient~     improvement in ventricular function after undergoing a standardized Left Ventricular Assist~     Device (LVAD) plus pharmacologic recovery treatment and testing protocol to allow removal of~     the LVAD within 18 months.~   "
136952|NCT01774643|"~     This is a feasibility study to perform image-guided liver biopsies in 25 patients who have~     pancreatic cancer with liver metastasis (cancer in the pancreas that has spread to the~     liver). This will contribute with samples for the bio-bank (bank of tumors) and develop~     xenografts (human tumors growing in mice) for further analysis of genes.~   "
136953|NCT01774630|"~     Chronic myeloid leukemia (CML) is a hematopoietic neoplasm characterized by the reciprocal~     translocation t(9;22). The resulting oncoprotein, bcr-abl is an essential trigger for growth~     and survival of leukemic cells. In the past decade, the bcr-abl tyrosine kinase inhibitor~     (TKI) imatinib (IM or Glivec©) has been the standard of care for patients with CML, inducing~     durable responses. However, requiring continuing IM indefinitely and the ability of IM to~     eradicate the CML clone was uncertain.~      In a small proportion of patients, IM can induce complete molecular response (CMR) defined by~     the disappearance of the bcr-abl transcript in conventional quantitative RT-PCR. The question~     whether or not these patients are cured and can discontinue drug therapy has been assessed by~     Mahon and coll, in the STIM study. He demonstrates that IM can be safely discontinued in~     patient with a CMR of at least 2 year duration and all patients who relapsed after IM~     discontinuation mainly did it in the first 6 months and responded to reintroduction of~     imatinib.~      Nilotinib is a rationally designed second generation tyrosine kinase inhibitor with improved~     target specificity over imatinib. Its efficacy and safety in the treatment of patients who~     are resistant or intolerant to imatinib as well as patients with newly diagnosed CML-CP led~     to the registration in second and first line treatment of CML-CP patients. Nilotinib produces~     even faster and deeper responses with more occurrence of CMR than does Imatinib.~     Consequently, one can assume that a more potent drug such nilotinib could induce deeper and~     sustained CMR allowing longer period off treatment than IM.~      The objective of this pilot trial is to assess if Nilotinib can rescue STIM patients in~     molecular relapse after IM discontinuation and to provide an estimation about duration of CMR~     after nilotinib discontinuation in 2nd line therapy among patients experiencing 2 years of~     stable CMR with nilotinib.~   "
136954|NCT01774617|"~     It is a cohort to evaluate the power of different diagnostic tests in predicting the~     prognosis of patients with severe liver disease.~      Patients with decompensated liver cirrhosis on the waiting list for liver transplantation~     will be evaluated with comparison of different diagnostic tests according to the MELD score~     (Model for End-Stage Liver Disease), MELD-Na (Model for End-Stage Liver Disease and sodium),~     indocyanine green clearance test, hepatic venous pressure gradient and transient~     elastography. All patients will be submitted to all the tests and prospectively followed for~     6 months, to establish mortality and complications related to liver disease in order to~     define the value of each method to predict outcomes.~   "
136955|NCT01774604|"~     The purpose of this study is to assess whether peri-procedural administration of rectal~     indomethacin, compared to placebo, can reduce the incidence of post-ERCP pancreatitis.~   "
136956|NCT01774591|"~     The purpose of the research is to evaluate the effect of azilsartan medoximil on blood~     pressure and urinary aldosterone levels in postmenopausal females.~   "
136957|NCT01774578|"~     The purpose of this study is to assess overall survival of anti-tumor immunization using~     HyperAcute®-Lung immunotherapy versus Docetaxel in patients with progressed or relapsed~     non-small cell lung cancer (NSCLC) that have been previously treated.~   "
136958|NCT01774565|"~     The main study objective is to compare conventional insulin therapy with automated~     closed-loop glucose control in achieving target glucose levels in hospitalised~     insulin-treated T2D subjects over 72 hours (phase 1) and inpatient hyperglycaemia requiring~     subcutaneous insulin therapy up to 15 days (phase 2).~      This is an open-label, two-arm, randomised, parallel design study in hospitalised~     insulin-treated T2D subjects (phase 1) and inpatient hyperglycaemia requiring subcutaneous~     insulin therapy (phase 2), during which target glucose levels will be controlled either by~     closed-loop system combined with (phase 1 only) once daily basal insulin injection or by~     conventional insulin therapy in random order.~   "
136959|NCT01774552|"~     Port-wine stain is a congenital, progressive vascular malformation of human skin involving~     post-capillary venules that occurs in an estimated 0.3% of children and can alter personality~     development and psychological in children.~   "
136960|NCT01774539|"~     Children who suffer fractures to the growth plates (physes) of their bones are at risk for~     premature growth arrest which can lead to long term complications. There is currently no~     technique to predict who is at risk of growth arrest following a physeal injury. The~     investigators aim to determine if diffusion MRI (an imaging method to analyze tissue~     properties) can effectively pick up differences between a healthy growth plate and an injured~     one. This would allow orthopaedics surgeons to predict which injuries are at a higher risk of~     growth arrest, so earlier interventions can be done in the orthopaedic clinic.~   "
136985|NCT01774214|"~     The purpose of this study is to determine which of two commonly used methods of manual~     pediatric fluid resuscitation (The Push-Pull Technique vs. the Disconnect-Reconnect~     Technique) allows for the most rapid administration of normal saline when this is urgently~     required.~   "
137055|NCT01773291|"~     The purpose of this study is to determine the therapeutic effect of acupuncture on severe~     head injury under conventional treatment. A double-blind clinical trial is conducted up to 6~     weeks and the change of subjects' Glasgow coma scale (GCS) and muscle power is measured.~   "
136961|NCT01774526|"~     Lung Cancer continues to be the major cause of cancer-related mortality in Singapore.~     Non-small cell lung cancer (NSCLC) accounts for 75% of lung cancers and adenocarcinoma is the~     most common histological subtype. Although cigarette-smoking is the main cause of lung~     cancer, more than a third afflicted in Singapore are never-smokers and 69% affect females.~     For the majority who present with advanced NSCLC, chemotherapy is the mainstay of treatment.~     Despite advances made with newer chemotherapeutic agents, it is apparent that the benefit of~     conventional chemotherapy has plateaued. Efforts toward developing novel treatments based on~     growing understanding of molecular oncology have yielded drugs that target vascular~     endothelial growth factor (VEGF) and epidermal growth factor receptor (EGFR). They have~     expanded treatment options for patients with advanced NSCLC. However, monoclonal antibody to~     VEGF is contraindicated in patients with squamous cell carcinoma due to increased incidence~     of fatal hemoptysis. EGFR tyrosine kinase inhibitors (EGFR-TKI) appear promising but only 40%~     of east-asian female never-smokers with lung adenocarcinoma harbour EGFR gene mutations.~     Estrogen, KRAS, BRAF, ERBE and other genetic mutations can confound response. Molecular data~     obtained from Caucasian and predominantly east-asian population may not apply to our~     multi-ethnic groups and our aim is to determine the molecular characteristics of our~     multi-ethnic asian phenotypes to better understand the process of carcinogenesis and~     treatment response as well as identify potential novel targets for future drug development.~     Paraffin-embedded tissues are recalled, and DNA is extracted for mutational analysis, which~     will be correlated to patient demographics, treatment and outcome.~   "
136962|NCT01774513|"~     The goal of this prospective study is to evaluate the feasibility of the Core Biopsy Needle~     with reverse bevel (Procore TM) in diagnosing autoimmune pancretitis~   "
136963|NCT01774500|"~     We study the hypothesis that combination of Proteine S100 beta and Copeptin within normal~     ranges can rule out seizure recurrences and severe outcome, and allow early discharge from~     the emergency department~   "
136964|NCT01774487|"~     The purpose of this study is to determine whether pentoxifylline reduces liver damage in~     infants with biliary atresia.~   "
136965|NCT01774474|"~     Cystoid macular edema (CME) is a common cause of vision loss after cataract surgery. In the~     last few years, several new treatments have been tried to address the problem of CME after~     cataract surgery in diabetic and non-diabetic patients. The investigators will perform a~     large RCT with the aim to provide more definite evidence-based recommendations for clinical~     guidelines to prevent the occurrence of CME after cataract surgery in patients with and~     without diabetes mellitus (DM).~   "
136966|NCT01774461|"~     The aim of this study is to investigate the effect of remote ischemic preconditioning on~     biochemical and functional indices of cardiac function induced by a 30 km run in healthy~     trained long distance runners.~   "
136967|NCT01774448|"~     People with dementia forget things and have trouble concentrating. In addition, they and~     their caregivers can become depressed. This project will show whether Mindfulness-Based~     Cognitive Therapy (MBCT) can lessen depression, increase attention spans and improve quality~     of life for those affected by the disease and their caregivers.~      MBCT combines intensive training in mindfulness meditation with Cognitive Behavioural~     Therapy. Studies show the meditation component creates changes in areas of the brain~     associated with our ability to pay attention. This form of meditation can help those impacted~     by dementia become more aware of their depressive thinking, leading to improved ways of~     coping.~      The investigators predict that individuals in the early stages of dementia and their spousal~     caregivers will report fewer depression symptoms following the 8-week Mindfulness-Based~     Cognitive Therapy (MBCT) Program, as well as experience improvements in quality of life and~     daily mindfulness.~      If successful, MBCT could improve the quality of life in individuals with dementia and their~     caregivers, as well as may take pressure off the health care system by delaying~     institutionalization.~   "
136968|NCT01774435|"~     This is an study evaluating the safety, tolerability, and PK of EN3342 in implantation~     durations of 6 months.~   "
136969|NCT01774422|"~     The patients affected by severe chronic respiratory failure can develop hypercapnic~     decompensation leading to coma and death in a few hours. At present, the main treatment is~     noninvasive or invasive ventilation. The noninvasive invasive ventilation requires a minimum~     of consciousness to insure spontaneous ventilation. In case of noninvasive ventilation~     impossibility, invasive mechanical ventilation is proposed to patients, which is an~     aggressive therapy. Regularly, the patients undergo this aggressive therapy without having~     expressed their opinion. Indeed, a great majority of these patients with severe respiratory~     insufficiency did not anticipate directives in case of respiratory decompensation~     (acceptation of aggressive treatments). Efficiency of these aggressive therapies is still~     uncertain but certainly alters quality of life (discomfort, loss of autonomy…). After~     complete, clear, loyal and adapted information, a majority of patient do not wish to go on~     these aggressive therapies. At the time of the decompensation, the patients are incapable to~     express an opinion because of the hypercapnic narcosis. An extracorporeal CO2 remover device,~     such as the DECAP CO2, would quickly decrease the hypercapnia what would allow the patient to~     improve his state of consciousness and so to find the conditions of spontaneous ventilation~     required for the noninvasive ventilation. The DECAP CO2 device can be used to stop quickly~     the hypercapnic narcosis and to collect the wills of the patient on the choice of possible~     aggressive therapies. It is in this last condition that we wish to estimate the DECAP CO2~     device.~   "
136986|NCT01774201|"~     Multiple sclerosis (MS) is a chronic progressive neurological disease. Respiratory~     dysfunction due to weakness in the respiratory musculature has been described in MS. This~     leads to increased morbidity and mortality in late stages of the disease. It is possible that~     respiratory dysfunction influence physical fitness in earlier stages as well. Walking~     disability and fatigue causes significant impact on health in patients with MS, even in~     earlier stages.~      The hypothesis is that there is a relationship between respiratory function, walking capacity~     and fatigue and that daily deep breathing exercise during two months will improve respiratory~     function, walking capacity and fatigue.~   "
136987|NCT01774188|"~     EECP therapy may affect the intraocular pressure while improving the ischemia systemic organ~     blood perfusion the same time. The present study investigated the impact of Enhanced~     Extracorporeal Counterpulsation treatment on the intraocular pressure.~   "
136970|NCT01774409|"~     It is a non-randomized, multicentric, cohort study, combined with a biological sample~     collection, a clinical data collection and with a genetic and immunologic biomarkers study.~      The ProfiLER program aims to implement a personalized cancer medicine approach by proposing~     to establish the genetic and immunologic profile of the tumor for patients with an advanced~     malignant tumor, in order to define a map of genetic (for the pre-identified target genes)~     and immunologic profiles for all the studied types of cancer. This study will also allow~     adapting the therapeutic management of these patients, if needed, by giving them targeted~     therapies or immunotherapies (commercialized on in ongoing clinical trials), based on the~     recommendations of the multidisciplinary molecular board.~      The genetic and immunologic profile of the tumor will be determined from archival or fresh~     collected (biopsy of a reachable lesion) tumor sample and from a blood sample. The~     correlation between genetic profiles of the tumor, patients immunity status and clinical data~     (progression, tumor response, etc.) collected from the patient medical records will probably~     allow us to identify biomarkers with a potential predictive value and to determine if some~     genetic disorders are linked to immunity status alterations.~   "
136971|NCT01774396|"~     Assessment of efficacy of hyaluronic acid - Emervel® Volume Lidocaine combined or not with~     Emervel® Touch and Emervel® Deep Lidocaine combined or not with Emervel® Touch in female~     patients with loss of fatty tissue in hands.~   "
136972|NCT01774383|"~     The ERD and ERS patterns of coordination between the STN and cortical regions in the~     termination of volitional movement in PD patients.~   "
136973|NCT01774370|"~     This is a prospective, non-interventional, open-label, multi-centre study. It will provide~     additional safety information of Pradaxa in Korean patients with non-valvular AF in clinical~     settings.~   "
136974|NCT01774357|"~     This is an observational registry study aiming to collect data on efficacy and safety of the~     single chamber Biotronik DX system with enhanced atrial diagnostics. The minimal follow-up~     period is 24 months. All analyses on the data will be done post-hoc; the study does not~     intend to confirm any pre-specified hypotheses.~   "
136975|NCT01774344|"~     This clinical study evaluates the efficacy and safety of regorafenib in patients with~     advanced liver cancer who have progressed on sorafenib treatment.~      Approximately 560 patients who meet the entry criteria will be randomly assigned in a 2:1~     ratio to regorafenib or placebo (1/3 chance to receive placebo).~      Primary endpoint of the study is overall survival.~   "
136976|NCT01774331|"~     Primary:~      • Demonstrate the utility of a new electronic data capture (EDC) system (CareExchange™) using~     infusion nurse measured physical, quality of life (QOL), respiratory, and disability~     assessments.~      Secondary:~        -  Change in Intravenous Immunoglobulin (IVIg) dose effects measured outcomes.~        -  Change in IVIg dose and timing effects measured outcomes.~        -  Change in patient status is reflected in measured outcomes.~        -  Assess the value to physicians from infusion nurse collected outcomes data.~        -  Identify types of patients by response to IVIg therapy (i.e. natural or poor~          responders).~        -  Change in response rate to IVIg therapy by disease state and demographics.~   "
136977|NCT01774318|"~     Due to the development of neonatal intensive care the number of surviving premature infants~     increased significantly. The immature brain undergoes a fair amount of external stimuli,~     which have a great impact on later cognitive development. Increasingly data show, that a~     delayed emergence of sleep-wake-cycling in newborns can be the first sign of brain injury.~     Studies have shown that clearly defined sleep states can be identified from 31-32 weeks of~     gestation onwards. But a few studies show, that also extremely premature infants already show~     cyclical variations of the background pattern within amplitude-integrated EEG (aEEG= a~     time-compressed, simplified EEG) and conventional EEG. This might resemble early~     sleep-wake-states and their presence correlates to the integrity of the central nervous~     system, although no clearly defined sleep states according to the classical definition can~     be identified. Complex EEG analysis needs the use of automated methods to exclude personal~     bias and to ensure gestational age specific data analysis. The newly developed NLEO algorithm~     was specially designed for EEG analysis of premature infants. Conventional EEG within this~     study will be analyzed visually and with the automated algorithm. In our research project we~     will study the emergence of Sleep-wake-cycling in extremely premature infants and its impact~     on their neurodevelopmental outcome prospectively. The different sleep and wake states will~     be derived from analysis of the conventional Video-EEG, aEEG and polysomnographic~     measurements. Visual analysis will include assessment of amplitudes and frequencies as well~     as the latencies and durations of EEG-Bursts and Interburst intervals. The automated~     NLEO-algorithm will be firstly used for comparison with above described visual analysis and~     secondly to find regions of interest involved in the organization of these early sleep~     states. The aim of this study is first to understand and analyze in detail the emergence of~     sleep-wake cycling including its disturbances in premature infants and to compare automated~     NLEO algorithm to conventional visual analysis methods. Secondly to correlate~     neurodevelopmental outcome to the emergence of sleep-wake-cycling.~   "
136978|NCT01774305|"~     Coughing during emergence from general anaesthesia may lead to dangerous effects including~     laryngospasm, detrimental haemodynamic changes. Post-thyroidectomy bleeding occurs in 1-4% of~     patients, and severe coughing may cause bleeding. Dexmedetomidine, a potent α adrenoreceptor~     agonist, is theoretically appropriate for reducing airway and haemodynamic reflexes during~     emergence from anaesthesia.~      In this study, we investigated whether intravenous single-dose dexmedetomidine at the end of~     surgery reduces coughing during extubation after thyroidectomy.~   "
136979|NCT01774292|"~     The purpose of the study is to determined whether the administration of alkalized 4%~     lidocaine (160 mg) in the endotracheal tube cuff is effective in diminishing the incidence of~     coughing at extubation in surgeries lasting more than 2 hours without the use of nitrous~     oxide as an anesthetic agent.~   "
136980|NCT01774279|"~     Anaplastic thyroid cancer has historically proven very difficult to research due to a~     combination of its rarity and the associated short survival period for those affected. In~     2009, 2340 patients in the UK were diagnosed with thyroid cancer with 70-90 expected to be~     the anaplastic subtype 1,2. For these patients average life expectancy is in the range of 2-6~     months with only a very small number surviving for more than one year. It is a highly~     aggressive form of cancer that is refractory to current treatment options. By collecting~     tissue and blood samples along with clinical data across the UK we will be able to accumulate~     numerically significant numbers of samples and data points which will facilitate research~     opportunities. Researchers will be encouraged to apply for access to the collected samples in~     order to try and establish the causal mechanisms for disease development, potential~     therapeutic targets and to relate clinical course and outcome with specific molecular~     defects. Due to the rarity it is not feasible for a single cancer centre or cancer network to~     accumulate sufficient samples for research in a meaningful timeframe hence the need for~     national collaboration in order to try and offer patients with this disease hope in the~     future.~      All UK patients with anaplastic thyroid cancer would be potentially eligible. The project is~     expected to run for at least 5 years and all thyroid cancer clinicians will be encouraged to~     participate. Patients will be asked to donate surplus thyroid cancer tissue following routine~     biopsy procedures along with an optional blood sample.~      2. Objectives~      Primary Objectives The primary objective of this project is to establish a national~     anaplastic thyroid cancer tissue collection to help facilitate both basic and translational~     research opportunities.~      There is no direct research question that the project itself addresses at this stage. The~     research proposals that subsequently arise as a result of this project will be generated by~     accredited research parties from the UK and potentially internationally. These research~     proposals will be submitted to the National Anaplastic Thyroid Cancer Tissue Bank and~     Database Project (NATT) Steering Committee for assessment. As the volume of material~     collected per patient is expected to be of small volume, by virtue of the specimen comprising~     core biopsy or fine needle aspirate material, research proposals will need to be prioritised~     according to the potential benefits the proposed research offers. Priority will be given to~     projects that may lead to the identification of potential therapeutic targets. Each research~     proposal will require their own ethical approval and research and development assessments~     before commencing.~      The steering committee will be multidisciplinary and will include nationally respected~     researchers and thyroid cancer clinicians.~      Scientific Justification The long term objective is to try and address the current lack of~     understanding about the aetiology and progression of this disease and ultimately to develop~     new therapeutic interventions that may slow the rate of disease progression, improve quality~     of life and prolong what is currently a very short survival.~      Due to the short prognosis following diagnosis it is notoriously difficult to run~     interventional therapeutic clinical trials in this patient population. Patients usually~     present with locally advanced and metastatic disease and as a consequence are often of poor~     performance status making clinical trial participation very problematic. If potential~     therapeutic targets could be identified in vivo it would potentially open up new therapeutic~     avenues whilst sparing some patients with the 'wrong' molecular profile futile treatment.~      This is a unique project within the setting of anaplastic thyroid cancer research.~   "
136981|NCT01774266|"~     In this proposal the investigators aim to develop a commercial kit to be used in primary~     screening and non-invasive triage for early detection of gastric cancer. This kit will be~     cost-effective and more accessible to the general population. In addition, the investigators~     would like to expand our current patent already submitted to INAPI (National Institute for~     Intellectual Property) and propose royalties to biomedical diagnostic companies for the use~     of our product at international level.~   "
136982|NCT01774253|"~     The purpose of this research study is to evaluate an investigational drug (Vismodegib) for~     Pontine Glioma that is growing or has come back (reoccurred). This study will look at the~     tumors response to the study drug, Vismodegib, and will also look at the safety and~     tolerability of Vismodegib.~      Vismodegib has been tested in multiple adult clinical trials and one pediatric trial.~     Laboratory testing in pontine gliomas suggests that this drug may be effective in treating~     this disease.~   "
136983|NCT01774240|"~     Delirium is a common yet under diagnosed condition in hospitalized patients, and the~     incidence have not previously been described in Danish cardiac surgery patients. The present~     study seeks to describe the incidence and duration of delirium in this group of patients,~     before and after the introduction of standardized screening tool and a guideline for~     treatment of delirium after cardiac surgery.~   "
136989|NCT01774162|"~     Endoscopic ultrasound (EUS) is a well-established tool for the diagnosis and staging of many~     gastrointestinal conditions, including but not limited to, malignant and pre-malignant~     neoplasms of the pancreas, esophagus, rectum, and submucosal tumors developing along the~     gastrointestinal tract. EUS is the most sensitive test for the detection of focal lesions~     within the pancreas and is the most accurate method for diagnosing pancreas cancer. A biopsy~     method for tissue sampling via EUS called fine needle aspiration (FNA) was developed that~     enables a small needle to be passed into the lesion of interest under ultrasound guidance,~     obtaining cellular material for cytology. EUS-FNA is currently recommended for the diagnosis~     of cystic and solid mass lesions within and adjacent to the gastrointestinal tract. Yet in~     certain clinical circumstances, it is more desirable and sometimes necessary to obtain a core~     tissue biopsy for histology rather than the cellular material for cytology obtained with~     EUS-FNA. Furthermore, histology may generally increase the diagnostic yield of EUS-FNA~     compared to cytology. It is with these aims in mind that a new type of needle, the fine~     needle biopsy (EUS-FNB) device was developed to enable core tissue sampling. Since a~     comparison of these to methods has yet to be made, the aim of this study is to perform a~     direct comparison of the sampling adequacy and diagnostic yield of the new EUS-FNB needle~     with the conventional EUS-FNA needle.~   "
136990|NCT01774149|"~     Patients with Diabetes Mellitus Type 1 using electronic self-help tools typically registers a~     large amount of data on their disease. The study intends to see if giving advanced feedback~     on these data can improve their blood glucose management.~   "
136991|NCT01774136|"~     This is a cluster randomized controlled trial (C-RCT) to evaluate the effectiveness of a~     Community-Integrated Management of Childhood Illness (C-IMCI) training for community~     caregivers (CCGs), adapted to include HIV-related interventions, on the delivery of maternal,~     newborn and child health interventions within households in rural communities in Ugu~     District, KwaZulu-Natal (KZN) Province, South Africa. The intervention includes two~     components: (1) a 2-week HIV/C-IMCI training for CCGs and their associated facilitators and~     supervisors, and (2) continuous support and supervision following the continuous quality~     improvement (CQI) framework, a low-technology approach to management and supervision of~     health programs. The primary objectives of the proposed evaluation are to measure the effect~     of the intervention on key outcomes, including early uptake of antenatal care, facility based~     delivery, postnatal visits, coverage of exclusive breastfeeding, and uptake of HIV PCR~     testing in infants at 6 weeks. We will also examine the effects of the intervention on~     immunization uptake up to 12 months and knowledge and practices of CCGs and mothers~     pertaining to maternal, newborn and child health.~   "
136992|NCT01774123|"~     To evaluate the ability of different spectral domain optical coherence tomography (OCT)~     devices, as well as different acquisition and analysis packages, to detect disease~     progression in patients with multiple sclerosis with and without a history of optic neuritis~   "
136993|NCT01774110|"~     A. Specific Aims:~      1. There is one specific aim of this study. The aim is to evaluate the effectiveness of early~     standardized task-specific training (ESTT) in persons with acute stroke.~      B. Hypothesis:~      1. It is our hypothesis that subjects who receive ESTT will walk faster and more~     symmetrically than published reports of gait outcomes in persons with stroke.~   "
136994|NCT01774097|"~     The purpose of this study is to find out if aldehyde dehydrogenase bright (ALDHbr) cells~     taken from a patient's bone marrow can be placed safely, via intramuscular injections, into~     their affected calf and lower thigh muscles and improve blood flow and/or peak walking time~     in patients experiencing pain associated with blocked blood vessels in the leg.~   "
136995|NCT01774084|"~     The purpose of this study is to determine whether preload of carbohydrate or water before~     elective hip replacement improve insulin sensitivity and or beta cell function in human.~   "
136996|NCT01774071|"~     The purpose of this study is to see if a new diagnostic research agent named~     89Zr-DFO-MSTP2109A can show prostate cancer tumors on a PET scan; as well as see how long~     89Zr-DFO-MSTP2109A lasts in the blood when given in small amounts. DFO-MSTP2109A is an~     antibody that works against STEAP1 - found on the surface of prostate cancer cells. Attached~     to the DFO-MSTP2109A is a radioactive material called 89ZR, which allows it to be imaged by a~     PET scanner. The results of this study may help researchers know whether 89Zr-DFO-MSTP2109A~     can be used as a diagnostic agent for finding prostate cancer that have STEAP1 on its surface~     with a PET scanner. The reason why identifying STEAP1 on prostate cancer cells is that new~     therapies are being developed to target STEAP1 prostate cancer cells.~   "
136997|NCT01774058|"~     A prospective case-control study was performed to investigate the effect of iloprost on the~     intraoperative flow volume in diabetic and non-diabetic patients as well as the effect of~     peripheral neuropathy in patients with peripheral arterial occlusive disease (PAOD)~     undergoing arterial reconstruction (primary endpoint).~      100 patients undergoing femoral artery reconstruction or femorodistal bypass surgery were~     included. Prior to surgery, peripheral nerve conduction velocity was measured. Blood flow~     volume at the common femoral artery was assessed using a Doppler flowmeter (Sono TT FlowLab;~     ) before reconstruction, prior to the intraarterial application of 3000ng of iloprost and 5~     and 10 minutes afterwards. Peripheral resistance units (PRU) were calculated as a function of~     mean systemic arterial pressure (MAP) and flow volume (VF): PRU = MAP (mmHg) / VF (ml/min).~   "
136998|NCT01774045|"~     The purpose of this study is to evaluate the safety of PDC-1421 Capsule in healthy subject,~     find the effective adequate dose for the next stage of the study, and accumulate information~     of possible mechanism of its anti-depressive effect.~   "
136999|NCT01774032|"~     The purpose of this study is to obtain immunogenicity and safety data of an H5N1 pandemic~     influenza vaccine in a Japanese elderly population aged 65 years and older.~   "
137000|NCT01774019|"~     The purpose of this study is to demonstrate that preoperative biliary drainage using~     self-expanding metal stents (SEMS) does not negatively impact overall surgical outcomes in~     patients undergoing pancreaticoduodenectomy for treatment of pancreatic or periampullary~     cancer.~   "
137001|NCT01774006|"~     Prospective randomized comparison of two widely used in vitro culture system in human IVF~     treatments. In vitro fertilized oocytes and embryos are cultured in individual culture media~     droplets using conventional petridish or in group culture using WOW (well of the well)~     petridish.~      Primary outcome: implantation and pregnancy rates Secondary outcome: fertilization rate and~     embryo quality~   "
137007|NCT01773915|"~     Alzheimer's disease (AD) is the most common neurodegenerative disorder afflicting the~     elderly. Currently, some biochemical tests performed on Cerebrospinal Fluid (CSF) samples~     have demonstrated to discriminate to some extend between AD and non-AD individuals based on~     the levels of tau, phospho-tau or Aβ42. We aim to investigate newly identified proteins whose~     levels increase during the Braak Stages of AD that are accessible in other body fluids such~     as blood, urine or saliva. The detection of these proteins would allow performing simple~     tests in case its levels were confirmed to be associated with the AD pathology.~   "
137008|NCT01773902|"~     Although expressed breast milk is considered the optimal nutritional source for preterm~     infants, the macronutrient content is insufficient to enable optimal growth during neonatal~     intensive care. Optimal dose and optimal mode of administration (standardized or~     individualized) of enteral protein supplementation to very preterm infants have not been~     established.~      This study aims to compare the effects on weight gain of different modes of enteral protein~     supplementation.~   "
137009|NCT01773889|"~     This study will test the hypothesis that adding pegylated IFN (IFN)a-2b to denileukin~     diftitox improves the potential of denileukin diftitox alone to deplete regulatory T cells~     (Tregs) and will thereby boost tumor immunity in patients with advanced-stage epithelial~     ovarian cancers, enhancing treatment efficacy.~   "
137010|NCT01773876|"~     Invasive Candida infections are burdened with a high mortality rate and is very common in~     intensive care units. This study aims to evaluate the efficacy of empirical treatment with~     micafungin in adult patients with suspected invasive candidiasis.~   "
137011|NCT01773863|"~     Community-acquired pneumonia is the most common infection leading to hospitalization in~     intensive care units and the most common cause of death associated with infection disease.~      Epidemiological studies have shown that respiratory tract infections are associated with an~     increased risk for the development of acute cardiovascular and cerebrovascular events.~      This link is further supported by studies indicating that influenza vaccination is associated~     with a reduced risk of hospitalization for pneumonia as well as heart disease and~     cerebrovascular disease.~      Data connecting acute respiratory tract infections and cardiovascular events stem almost~     exclusively from cross-sectional or retrospective studies. Thus the real incidence and the~     prognostic impact of AMI, as well as the pathophysiological relationship between pneumonia~     and cardiovascular damage is still elusive.~      Inflammation plays a major role in the pathogenesis of coronary artery disease. The increased~     concentrations of proinflammatory cytokines together with the activation of coagulation, the~     down-regulation of anticoagulant mechanisms and the enhanced platelet aggregation may trigger~     atheroma's instability, plaque rupture and thrombus formation.~      Inflammation and coagulopathy are also considered universal host responses to infection in~     patients with severe sepsis. Thus far limited data are available on the changes in these high~     regulated systems, together with platelet activity in patients with CAP and their potential~     relationship with cardiovascular risk.~      This project will consist in a prospective multicenter study to investigate the incidence of~     major adverse cardiac and cerebrovascular events (MACCE) in hospitalized patients with CAP,~     its prognostic relevance and the potential relationship between enhanced cardiovascular risk~     and the activation of inflammation, coagulation and platelet aggregation in this setting.~   "
137012|NCT01773850|"~     The goal of the study is to compare the radiologist confidence level in evaluating patients~     with known breast lesions using a carbon nanotube x-ray based stationary breast tomosynthesis~     imaging device. The comparison will be made against conventional mammography acquired as a~     part of a standard clinical workup. One hundred patients who are to have a clinical surgical~     breast biopsy will be recruited for the study. A reader study will be performed to evaluate~     the ROC characteristics of the system.~   "
137013|NCT01773837|"~     Fatigue is the most prevalent symptom in advanced cancer patients, interfering functional~     capacity, social relations, wellbeing, and quality of life. Methylphenidate is a central~     nervous system stimulant that has traditionally been used in cancer patients to manage~     depression, opioid‐induced sedation, hypoactive delirium due to multiorgan failure, and~     cognitive disorder associated with brain tumors. Although there is evidence from prospective~     studies of the efficacy of this drug in cancer‐related fatigue, the only one randomised~     clinical trials gave non-conclusive results. In order to define the real efficacy of~     methylphenidate in this setting, the investigators designed a new clinical trial comparing~     methylphenidate and placebo in cancer‐related fatigue, assessed both by the verbal numeric~     scale (VNS) included in the Edmonton Symptom Assessment System (ESAS) and the subscale for~     fatigue of the Functional Assessment of Cancer Therapy (FACT‐F). The investigators will~     include 122 advanced cancer patients with fatigue ≥ 5/10 (VNS, from 0 to 10) and hemoglobin ≥~     9 g/dl. Patients will be randomized to methylphenidate or placebo. Doses will be adapted to~     response within a range from 10 mg at morning time and 5 at noon, to 25 mg/day. Assessment of~     response will be performed on day 3 and day 6 with ESAS and FACT‐F. Drug‐induced adverse~     events will be checked. The VNS of fatigue on day 6 will be consider the primary endpoint.~   "
137014|NCT01773824|"~     To evaluate the effect of a continuous postal and web-based feedback and peer comparison~     system of individual antibiotic prescription rates on the prescription behaviour of primary~     care physicians in Switzerland.~   "
137015|NCT01773811|"~     The current study proposes to directly measure how processing after participating in written~     disclosure about a traumatic life event affects physical and psychological outcomes.~   "
137016|NCT01773798|"~     This trial is conducted in Europe. The aim of the trial is to investigate the pharmacodynamic~     (the effect of the investigated drug on the body) and the pharmacokinetic (exposure of the~     trial drug in the body) properties of insulin degludec/insulin aspart 15 in subjects with~     type 1 diabetes.~   "
137017|NCT01773785|"~     The primary purpose of this study is to determine the effectiveness of SPI-1620 in~     combination with docetaxel in patients with advanced biliary cancer.~   "
137018|NCT01773772|"~     The purpose of this study is to learn more about how gonadotropin-releasing hormone (GnRH)~     and luteinizing hormone (LH) pulses are controlled during puberty. In this study, the~     investigators aim to discover whether or not giving 2 small doses of progesterone to early~     pubertal girls will prevent the nighttime increase of GnRH and LH pulses. From the~     information gathered in this study, the investigators may be able to learn more about how~     menstrual cycles are normally established in girls during puberty. Ultimately, if these~     normal processes can be understood, the investigators may be able to better understand~     abnormalities of puberty.~   "
137019|NCT01773759|"~     Ensuring that all children are fully immunized against vaccine-preventable diseases is a~     critical public health issue. Child care programs are critical targets for efforts to~     increase the proportion of infants and young children who are fully immunized. The primary~     objective of this proposal is to rigorously examine current state, local government, and~     child care providers' efforts and barriers to ensuring that all enrolled children are~     up-to-date for required immunizations and to evaluate strategies to improve immunization~     coverage in child care programs.~   "
137020|NCT01773746|"~     The most appropriate initial oxygen concentration for the resuscitation of the extremely low~     birth weight infant has not been established using large well designed, randomized, blinded,~     prospective trials and the level of oxygen utilized by practitioners in this situation is~     highly variable. This proposed trial will use targeted oxygen saturation levels over the~     first 15 to 20 minutes of life to compare a low and a higher initial oxygen level for the~     resuscitation of such infants, and will be large enough to evaluate short term outcomes of~     survival without oxygen at 36 weeks and survival without retinopathy of prematurity, and the~     long term outcome of survival without significant neurodevelopmental impairment at 2 years of~     age. Such information is urgently required to provide an evidence basis for the initial~     oxygen concentration for resuscitation of these very preterm infants.~   "
137021|NCT01773733|"~     The aim of this study is to summarize the data on efficacy and safety of Reduxine~     administration in the routine clinical practice according to the approved indications.~   "
137022|NCT01773720|"~     The aim of our study was to evaluate the reliability of uncalibrated cardiac index monitoring~     based on arterial waveform analysis in patients undergoing off-pump coronary artery bypass~     grafting.~   "
137023|NCT01773707|"~     The study is a 2-arm, multicenter, 1:1 randomized, placebo controlled clinical trial.~      All subjects will receive close monitoring for development of AGT or T1DM. Subjects will~     receive Abatacept or placebo and close monitoring for development of AGT or T1DM. To assess~     the safety, efficacy, and mode of action of Abatacept to prevent AGT and T1DM.~      The primary objective is to determine whether intervention with Abatacept will prevent or~     delay the development of AGT in at-risk autoantibody positive non-diabetic relatives of~     patients with T1DM.~      Secondary outcomes include: the effect of Abatacept on the incidence of T1DM; analyses of~     C-peptide and other measures from the OGTT; safety and tolerability; and mechanistic~     outcomes.~   "
137024|NCT01773694|"~     Patients are often counseled to keep a surgical wound dry for 2 to 3 days. The rationale is~     likely to decrease the risk of infection and bleeding. However, this has never been formally~     studied. Patient's routines are likely disrupted when they are asked to avoid wetting the~     area. The investigators will perform a controlled study to determine if avoidance of~     post-operative wetting is necessary.~   "
137025|NCT01773681|"~     The purpose of this study is to use magnetic resonance imaging (MRI) and high-resolution~     peripheral quantitative computed tomography (HR-pQCT) techniques to look at the damage and~     disease activity progression in the hand and wrist joints of patients with rheumatoid~     arthritis.~      The central hypothesis is that ongoing erosions and cartilage loss in rheumatoid arthritis~     are due to persistent inflammation, which is poorly detected by clinical examination and~     markers of systemic inflammation.~   "
137026|NCT01773668|"~     The purpose of this study is to collect performance data on the Integrated sensor and~     infusion set during 3 days of use and demonstrate performance adequacy of the integrated~     sensor and infusion set with glucose sensing and insulin delivery functionalities. The~     hypothesis of this study is that having the infusion of insulin in close proximity to the~     sensor does not interfere with the sensor accuracy. This study focuses on high bolus~     patients. A high bolus is defined as 12 units or more.~   "
137027|NCT01773655|"~     The goal of this protocol is to determine the prevalence of somatic and germline mutations in~     BAP1 (BRCA associated protein-1) among patients with mesothelioma , choroidal nevus, primary~     uveal melanoma (UM), or metastatic UM seen at our institution.~   "
137028|NCT01773642|"~     With increased availability of antiretroviral therapy (ART) and improved care, increasing~     numbers of perinatally infected children are surviving into adolescence. While HIV care and~     treatment programs are expanding, growing challenge faced by health providers and caregivers~     is diagnosis disclosure to HIV infected children.~      The investigators propose a 4 year project to test the effectiveness of a~     cognitive-behavioural intervention that the investigators have designed to support~     developmentally appropriate disclosure to HIV infected children by their caregiver.~      The investigators hypothesize that the intervention will lead to increased disclosure rates~     and will over time improve health and mental health outcomes among caregivers and children in~     the intervention group compared to those receiving standard care. The findings of the study~     will inform Ugandan and other countries' national policies on pediatric HIV care and~     treatment.~   "
137029|NCT01773629|"~     The investigators will evaluate effects of introducing the care manager on:~        1. Patient receipt of timely diagnosis and initiation of treatment for major depression~          (diagnosis within 2 weeks of screening and treatment within 1 month of diagnosis); and~        2. Patient continuity of care for depression across the transition of care from pregnancy~          to postpartum (within 4 months postpartum).~   "
137030|NCT01773616|"~     The treatment of the multisystem autoimmune disease systemic lupus erythematosus (SLE)~     remains a challenge, particularly when there is renal involvement (lupus nephritis). For the~     last 60 years corticosteroids have been the backbone of the treatment of lupus nephritis but~     they are associated with significant toxicity.~      Although randomized placebo controlled trials of Rituximab in non-renal lupus and lupus~     nephritis did not meet their primary end-points, there is accumulating data that suggests~     that B cell depletion with Rituximab may be efficacious in lupus disease refractory to~     conventional therapy. Furthermore, our pilot data suggests that the addition of Rituximab to~     mycophenolate mofetil (MMF) without oral steroids is at least as effective at inducing a~     renal response as the standard of care therapy comprising MMF and high dose oral~     corticosteroids.~      RITUXILUP is a proof of concept, open labeled, randomized, controlled, multicentre trial that~     aims to demonstrate whether the addition of Rituximab to MMF therapy is useful in treating a~     new flare of lupus nephritis and whether it has a long lasting steroid-sparing, beneficial~     effect with equal efficacy and greater safety than a conventional regimen of MMF and oral~     prednisolone. If successful, this trial has the potential to dramatically change the~     management of lupus nephritis.~   "
137031|NCT01773603|"~     Choosing the best embryo for transfer has become the major challenge in in vitro~     fertilization (IVF). Morphology alone is obviously not enough and time-lapse incubation has~     added embryo development kinetics as another selection criterion.~      This study was designed to select for the top blastocyst to be replaced, while increasing the~     pregnancy chance, with the local legislation regulating the number of embryos to be~     transferred and to establish a morphokinetic standard to be used in our clinical setting.~   "
137032|NCT01773590|"~     The aim of this study is to investigate the mechanisms of interplay between allergy (IgE and~     Th2 mediated inflammation) and virus infection in the development of asthma, as well as the~     risk and severity of acute exacerbations of asthma. Understanding these mechanisms should~     identify new approaches for novel therapies for the prevention of asthma development and for~     prevention/treatment of asthma exacerbations. Such treatment has potential to have a major~     impact on patient quality of life and to result in enormous reductions in health care costs.~      A human model will be used to identify dysregulated genes/proteins and determine~     relationships with disease outcomes. This study will compare lower airway responses between~     asthmatic and healthy control subjects undergoing rhinovirus (RV) experimental infection~     (subjects will be infected with rhinovirus as part of the study). This will have the dual~     advantage of investigating mechanisms in the most natural model possible, as well as~     developing a better model for testing novel therapeutic approaches. The investigators will~     analyse the samples from both subject groups, to determine their relevance to the human~     disease. Any genes/proteins shown to be dysregulated and related to disease outcomes in the~     human model will be very strong candidates for immediate translation into human intervention~     studies.~      Up to 12 asthmatic and/or healthy subjects will be recruited for a preliminary pilot study.~     These subjects will be ineligible to enter the main study due to the presence of neutralizing~     antibody to RV16 (~50% of subjects otherwise suitable for the study). These subjects will~     meet all other inclusion/exclusion criteria for the main study. The 12 participants will~     undergo tests including a single bronchoscopy, nasal sampling and blood tests allowing for~     optimisation of all sample processing techniques. They will not be infected with RV-16.~      In the main study the investigators will aim to study up to 15 healthy volunteers and 15~     volunteers with moderate asthma (all on inhaled steroid treatment). Subjects will undergo a~     single baseline bronchoscopy 2 weeks prior to inoculation with the RV16 virus. Following~     infection with the virus participants will be required to attend for regular sample~     collection including 2 further bronchoscopies post-infection. Patients will be followed until~     convalescence 6 weeks post infection.~   "
137033|NCT01773577|"~     Goal: To evaluate the effects of Interoperable Health IT on provider work flow and work~     practices in the ambulatory care setting.~      Interoperable health IT can produce a reduction of barriers in the exchange of health~     information that can allow for more efficient, timely, and a higher quality of patient care.~     This study seeks to evaluate the effects of the implementation of interoperable health IT on~     the work flow of medical providers in the care environments in which they are implemented.~   "
137034|NCT01773564|"~     Intravascular devices in intensive care units are often associated to complications. The~     investigators estimate that 23.5% of catheters placed and used in intensive care are subject~     to at least one complication; the investigators goal is to demonstrate the effectiveness of~     the new Tegaderm ™ IV Advanced dressings to achieve a decrease of 35% in the number of~     complications associated with intravascular catheters in intensive care.~   "
137035|NCT01773551|"~     The purpose of this research study is to investigate whether breast density measured by a~     safe, painless imaging method (called Diffuse Optical Spectroscopic Imaging - DOSI) can~     detect the decrease of breast density in subjects who receive tamoxifen when compared to~     patients who do not receive any drug. If decreased density can be reliably detected, it may~     help determine which subjects will benefit by taking tamoxifen or other chemoprevention~     drugs.~   "
137036|NCT01773538|"~     The investigators wish to investigate how the Continuous Reaction Time (CRT) method can be~     used in the diagnosis and monitoring of covert hepatic encephalopathy (cHE)in patients with~     cirrhosis of the liver. The hypothesis is that the CRT method (duration 10-2 minutes) can~     serve as a tool in the diagnosis and monitoring of cHE and is an alternative to using the~     Portosystemic Encephalopathy Test (PSE)(duration 20-25 minutes).~   "
137037|NCT01773525|"~     The purpose of this study is to test the use of a tool (NOTSSdk)to assess and provide~     feedback to trainee surgeons' non-technical skills. It focuses on two aspects: reliability of~     ratings of trainee surgeons using NOTSSdk; and the content and quality of feedback given to~     trainees based on observations using NOTSSdk.~   "
137038|NCT01773512|"~     -  The prediction of extent and risk profile of coronary atherosclerosis based on clinical~          evaluation and non-invasive techniques.~        -  Detailed analysis of plaque volume, plaque composition, risk plaque features and shear~          stress (WSS) changes during lipid lowering therapy (rosuvastatin 40mg) from 3D vessel~          reconstruction.~        -  Prediction of changes in coronary arteries based on changes in non-invasive~          examinations.~        -  Examination of WSS influence on atherosclerosis development and changes of WSS during~          lipid lowering therapy.~   "
137039|NCT01773499|"~     Skin and soft tissue infections represent a tremendous burden to the health care community~     with over 11.6 million ambulatory patients presenting annually in 2003 and 14.2 million in~     2005. A Cochrane review of cellulitis found that there is limited data to support any~     specific antibiotic or even a specific length of antibiotic therapy, and that outpatient~     therapy for cellulitis is increasing. Soft tissue ultrasound has been shown to have utility~     in differentiating cellulitis from abscess but its role in patients with cellulitis is not~     well developed. Although speculative, the investigators hypothesize that sonographic features~     of cellulitis are associated with clinical improvement and successful therapy following~     antibiotics for patients with cellulitis.~   "
137040|NCT01773486|"~     This study will examine whether hesperidin, a major component of citrus fruits, affects how~     the body responds to insulin in healthy and obese people. Laboratory studies suggest that~     hesperidin treatment lowers blood pressure, lowers blood sugar and increases blood flow. This~     study will see if hesperidin improves insulin resistance or insulin's effects on blood flow~     in people with insulin resistance.~      Healthy normal weight or overweight people between 21 and 65 years of age may be eligible for~     this study. Participants are randomly assigned to take hesperidin or a placebo (inactive~     dummy pill ) for a 4-week treatment phase.~   "
137041|NCT01773473|"~     The purpose of this study is to determine the efficacy and safety of insulin Lispro Mix25~     (LM25) compared to insulin Lispro Mix50 (LM50) as an insulin starter in participants with~     Type 2 diabetes mellitus (T2DM).~   "
137042|NCT01773460|"~     Everolimus will be given to patients with metastatic breast cancer who already has a progress~     taking Everolimus but with a change in the endocrine treatment.~   "
137043|NCT01773447|"~     The investigators hope to compare two different methods of closing skin wounds using sutures.~     One of these methods (the set-back technique) was recently described in 2010 and has been~     reported to be technically easier and reduces the chance of spitting sutures (deep sutures~     that are pushed to the surface of the skin as the wound heals). The other method (the~     vertical mattress technique) has been used for many years with good results. However, no~     controlled studies have been performed to clearly demonstrate a difference between the two~     methods. We hope to find differences in the height of the wound edges immediately after~     surgery(5 minutes following the procedure) as well as the appearance of the scar and symptoms~     associated with the scar 3 months after surgery.~   "
137044|NCT01773434|"~     This is a multicenter, multiple doses, open-label Phase 1 study of MORAb-004 in subjects with~     solid tumors. Subjects may have any solid tumor without intracranial involvement or~     metastases that has failed standard chemotherapy.~      This study will be conducted in 2 parts: 1) Part 1 will be the dose escalation portion of~     this study to assess the tolerability and the safety profile of MORAb-004. Dose will escalate~     in different cohorts as follows: 2, 4, 8 and 12 mg/kg weekly dosing each as a 4-week cycle~     with no intra-subject escalation. Individual participants may have additional cycles at the~     same dose until disease progression unless the participants meet the discontinuation~     criteria.~      2) Part 2 will comprise cohort expansions to further characterize the safety and tolerability~     of MORAb-004 and to assess preliminary efficacy and the pharmacokinetic/pharmacodynamic~     relationship of MORAb-004 in gastric cancer and hepatocellular carcinoma (HCC). Three dose~     levels will be expanded based on the safety profile that was obtained in the dose escalation~     portion of this study (Part 1): 4 mg/kg (administered on a weekly basis), 8 mg/kg~     (administered on a weekly basis) and 12 mg/kg (administered every OTHER week).~   "
137045|NCT01773421|"~     This study consists of two Parts. Part A (Food Effect Study) and Part B (Determination of MTD~     for BID Dosing).Part A will be initiated first, and Part B will be initiated after the PK~     results of Part A have been evaluated.~   "
137046|NCT01773408|"~     This Phase 1/1b, open-label study will evaluate the safety and pharmacokinetics of escalating~     doses of RO5503781 as a single agent or in combination with cytarabine in participants with~     acute myelogenous leukemia. In Part 1, RO5503781 will be administered in escalating doses as~     a single agent, and in Part 2, RO5503781 will be administered in combination with cytarabine.~     An optional Part 3 in which RO5503781 will be administered with cytarabine and anthracycline~     may be considered . In Part 4, the safety and pharmacokinetic profile of an optimized~     formulation of RO5503781 in combination with cytarabine will be assessed.~   "
137047|NCT01773395|"~     This research study is a Phase II clinical trial. Phase II clinical trials test the~     effectiveness of an investigational intervention to learn whether the intervention, in this~     case, the GVAX vaccine, works in preventing your MDS, CMML, or AML from relapsing after your~     allogeneic stem cell transplantation. Investigational means that the vaccine is still being~     studied and that research doctors are trying to find out more about it-such as the side~     effects it may cause, and if the vaccine is effective. It also means that the FDA has not yet~     approved the vaccine for your type of cancer.~      You are being asked to participate in this trial because you have advanced myelodysplastic~     syndrome (MDS), Chronic Myelomonocytic Leukemia (CMML), or acute myeloid leukemia (AML). Your~     doctor has determined that you are a candidate for an allogeneic stem cell transplant as~     treatment for your MDS/CMML/AML. Allogeneic stem cell transplantation is a standard treatment~     for MDS/CMML/AML. It can be effective because the cells from your donor (also known as the~     graft) could form a new immune system that can fight against the MDS/CMML/AML cells in your~     body. This is also known as the graft-versus-leukemia or GVL effect. In patients with~     advanced MDS, CMML, or AML that is not in remission at the time of transplantation, as in~     your case, relapse remains the number one cause of transplant failure. As such, this clinical~     trial is designed to assess whether adding a leukemia vaccine early after transplantation~     could stimulate donor cells to fight your cancer and improve transplant outcomes.~      In recent years, researchers at the Dana-Farber Cancer Institute have discovered that GVAX, a~     vaccine made from the patient's own cancer cells engineered to produce a protein called~     GM-CSF, can be effective in stimulating a powerful immune response specific to that cancer.~     GM-CSF is a naturally occurring hormone in the body that helps the immune system fight~     infections and diseases. The GVAX vaccine is made in the laboratory by using a virus (called~     adenovirus, which has been modified so it cannot cause illness) to insert the GM-CSF gene~     into tumor cells. The cells are then irradiated, which prevents them from being able to grow,~     before being administered to patients in a series of vaccinations.~      A previous phase I clinical trial using this GVAX vaccine in patients with MDS/AML after~     allogeneic transplantation demonstrated that the GVAX vaccine is safe, and the survival~     outcomes were encouraging. The current randomized phase II study will investigate this~     vaccine further and gather more information to assess the activity.~      If you participate in this research study, you will be randomized to receive either GVAX~     vaccination or placebo (a saline solution) vaccination. Randomization means that you are put~     into a group by chance. It is like flipping a coin. There is a 50% chance that you will~     receive the GVAX vaccine and a 50% chance you will receive placebo. Neither you nor your~     transplant doctor(s) will know which you will be receiving.~      The primary goal of this trial is to assess if there will be a difference in the percentage~     of cancer free survivors in the vaccinated vs. placebo group at 18 months after transplant.~   "
137048|NCT01773382|"~     The study aims to explore the non-pharmacological treatment of IgA nephropathy by weight~     reduction. The investigators hypothesized that benefits of weight loss may reduce~     proteinuria.~   "
137049|NCT01773369|"~     Early childhood injuries such as perinatal (around birth) stroke are devastating because the~     child lives with the problem for life, typically close to a normal lifespan. One~     'opportunity' presented by a brain injury early in life compared to later in adulthood is~     that the young brain is much more plastic (malleable) and receptive to interventions. This is~     particularly true for neural circuits that are still under development. We will test the~     hypothesis that early (<2 yr old), intensive leg training will improve walking more than no~     training or training at >2 yr old. We will further determine the changes induced by training~     in motor and sensory pathways.~   "
137050|NCT01773356|"~     The objective of this study is to test the effect of dihydrocapsiate on energy expenditure in~     women.~   "
137051|NCT01773343|"~     To compare efficacy and adverse effects of fractional CO2 laser of acne scars treatment with~     1 versus 3 months intervals~   "
137052|NCT01773330|"~     This study is using a new technology known as high resolution manometry which is used to~     evaluate patients that have trouble swallowing or have chest pain that is not related to the~     heart. The investigator wants to learn how the different positions of the body, in a lying~     position, semi-recumbent, sitting position or standing up, and the amount of liquid affects~     the outcome of the test. This will help the investigator to determine a standardized protocol~     for patients with trouble swallowing.~   "
137053|NCT01773317|"~     A prospective randomized controlled trial will be used to evaluate the efficacy of~     post-operative perturbation training. 80 patients who were regular participants in activities~     that involve cutting, pivoting, jumping, and lateral movements prior to injury who range in~     age from 13-55 at the time of injury are eligible. All eligible subjects must undergo primary~     anterior cruciate ligament reconstruction. Using a prospective randomized design, 40 subjects~     who will be block randomized by sex to 40 patients who will receive 10 sessions of~     post-operative perturbation training in addition to standard agility and return to activity~     progression and forty who receive only standard agility and return to activity progression.~     Post-operative perturbation training will be initiated when the athlete is at least 12 weeks~     post-anterior cruciate ligament reconstruction, has full range of motion and achieves 80%~     quadriceps strength symmetry, the criteria we currently use for beginning return to activity~     progression.~   "
137054|NCT01773304|"~     The purpose of this randomized, controlled, cross over single meal study is to investigate~     the metabolic effects of a breakfast rich in dairy proteins and to determine biomarkers for~     their intake. The results from this project will increase our knowledge about nutritional~     value of dairy proteins, which is necessary to decide whether dairy products can be~     recommended for prevention of weight related bone loss.~   "
137056|NCT01773278|"~     Patients with biochemically confirmed SLOS are being treated with cholesterol supplementation~     and antioxidant medication. They are carefully monitored with visits to clinic, laboratory~     testing including cholesterol and 7-dehydrocholesterol levels, vitamin levels, blood counts~     and liver and kidney function. On an annual basis, the patients undergo a series of tests~     under anesthesia, including electroretinogram (ERG), brainstem audiometry (ABR), and~     ophthalmologic exam under anesthesia to follow pigmentary retinopathy.~   "
137057|NCT01773252|"~     The purpose of this study is to evaluate the sensitivity and specificity of the Cardiox Flow~     Detection System (FDS) in identifying an intracardiac right-to-left shunt (RLS) compared to~     the results of transesophageal echocardiography (TEE).~      RLS intracardiac shunts are associated with a number of clinically important syndromes~     including paradoxical thromboembolism (causing stroke or other systemic infarct), migraine~     headaches (particularly with aura), desaturation with obstructive sleep apnea, and~     decompression illness. From a research perspective, the detection of shunts in subjects with~     these types of syndromes is critical in helping to define the role of RLS in these disease~     processes. From a clinical perspective, shunt detection will be increasingly important in an~     era where interventional procedures for repairing cardiac defects are available for subjects~     determined to be at risk.~      The currently accepted reference standard for detection of an intra-cardiac patent foramen~     ovale/atrial septal defect (PFO/ASD) RLS is a transesophageal echocardiography (TEE), a~     procedure that is invasive, uncomfortable, and requires conscious sedation.~      Alternative options include transthoracic echocardiography (TTE) with injection of agitated~     saline (with and without Valsalva strain), a procedure that is far less sensitive than TEE~     due to the echocardiography imaging limitations seen in many adults.~      Finally, transcranial Doppler (TCD) with injection of agitated saline (with and without~     Valsalva strain) is a newer entrant into this arena that does not require sedation or any~     invasive instrumentation.~      The Cardiox Model 100 FDS utilizes an optical sensor positioned on the surface of the~     subject's skin at the scaphoid fossa of the ear. Next, a predetermined dose of an indicator~     dye, indocyanine green (ICG), is injected at a predetermined rate into a peripheral~     antecubital vein of the subject while the subject performs a breathing maneuver called a~     Valsalva maneuver. The exhalation by the subject into a mouthpiece connected to a pressure~     transducer via a flexible tubing extension, or its equivalent (ie, performing the Valsalva~     maneuver), is an essential step for all existing RLS detection methods. The Valsalva maneuver~     by the subject creates a pressure differential between the right and left sides of the heart.~     This Valsalva maneuver results in blood flow from the right side of the heart to the left~     side of the heart through an ASD, and/or causes a PFO, if present, to open, also allowing~     blood to flow directly from the right side to the left side of the heart without passing~     through the lungs (pulmonary vasculature) for oxygenation.~      The Earpads, including their fluorescence sensor arrays (FSA), are used to measure the~     relative concentration (ie, fluorescence signal level) of ICG dye in the bloodstream as a~     function of time. If a premature inflection or peak occurs in the ICG dye concentration level~     at a time point prior to the rise and fall of the concentration associated with the main~     bolus of indicator, then a RLS is present in the heart. The amplitude of this premature ICG~     dye-dilution curve (referred to as RLS-indicator dilution curve) is used to subsequently~     quantify the magnitude of the right-to-left shunt by ratiometrically comparing the amplitude~     of this RLS indicator dilution curve to the amplitude of the main indicator dilution curve~     associated with that portion of the injected ICG dye that follows the normal pathway from the~     right side of the heart, through the lungs, and into the left side of the heart (referred to~     as normal indicator dilution curve).~   "
137058|NCT01773239|"~     The purpose of this study is to test a new computerized training program as well as to find~     out whether the computer training might help people who have schizophrenia. The investigators~     will study the effects of the computer training on how people with schizophrenia think about~     social interaction and on their social skills. At completion of training, TARA subjects will~     show improvement on measures of social cognition compared to their baseline performance.~   "
137059|NCT01773226|"~     This prospective single-center study will evaluate the safety and tolerability of a single~     dose of APS(TM) treated patients with OA of the knee who have failed conservative OA~     therapy. The study will also evaluate efficacy by assessing patient pain and functionality.~   "
137060|NCT01773213|"~     In this randomized, double-blind clinical trial including patients with a neurogenic lower~     urinary tract dysfunction undergoing urodynamic investigation at the Spinal Cord Injury~     Center, Balgrist University Hospital, Zürich, we aim to investigate whether the detrusor~     contraction during the ice-water-test is provoked by the ice water or the rapid filling.~   "
137061|NCT01773200|"~     Aneurysmal subarachnoid hemorrhage is a common and serious disease associated to a high rate~     of mortality and morbidity. Severe definitive neurological impairment can concern up to 30%~     of patients in relation with elevated intracranial pressure, hemorrhage recurrence and~     symptomatic cerebral arterial vasospasm. This latter complication is defined as a reversible~     reduction of cerebral artery's diameter occurring between the 4th and the 14th day after~     bleeding. Physiopathology is not well understood, but could involve endothelium, trough~     endothelial progenitor cells (EPC). Circulating EPC are bone marrow-derived cells with~     capacity of vasculogenesis and angiogenesis. EPC have been recognized playing a beneficial~     role in cardiovascular disease and ischemic stroke. EPC have never been studied in aneurysmal~     subarachnoid hemorrhage.~      The primary objective of this study is to compare the number of circulating endothelial~     progenitor cells between patients with a good neurological outcome (defined as a glasgow~     outcome scale = 1 or 2) and patients with a poor neurological outcome (glasgow outcome scale~     = 3, 4 or 5).~      Briefly, the number of circulating EPC will be measured at admission, and at day 3, 6, 10,~     14, 21 in each consecutive patient suffering aneurysmal subarachnoid hemorrhage and~     hospitalized in Teaching Hospital of Besançon (France). The neurological outcome will be~     measured one year after subarachnoid hemorrhage.~   "
137062|NCT01773187|"~     The primary hypothesis of the study is that treatment with pacritinib results in a greater~     proportion of patients achieving ≥ 35% reduction in spleen volume from baseline to Week 24~     than treatment with BAT.~   "
137063|NCT01773174|"~     Study will assess PK/PD parameters and safety and tolerability of the study medication in~     this age group~   "
137064|NCT01773161|"~     Children with cerebral palsy are at an increased risk of having their hips move partially or~     completely out of joint. This can cause pain and restrict movement at the hip, making sitting~     in a wheelchair uncomfortable and make personal care difficult. This condition may be treated~     with surgery. Surgeons use x-rays taken before and after the surgery to determine whether or~     not the surgery has been successful. However, it is also important to know whether the~     surgery has improved life from the child or the caregiver's point of view. The investigators~     will also evaluate if waiting for surgery affects the child. This information will be added~     to results from a physical exam and an evaluation of the child's x-rays for a more complete~     picture of how this surgery impacts the lives of our patients. It is predicted that that the~     health-related quality of life of children with cerebral palsy will improve following~     surgery.~   "
137065|NCT01773148|"~     The goal of this study is to assess the safety and effectiveness of the AXERA Access System~     in subjects undergoing Common Femoral Artery (CFA) access for Percutaneous Coronary~     Intervention (PCI) and/or Peripheral Vascular Intervention (PVI) through a 5 French (F) or 6F~     introducer sheath.~   "
137066|NCT01773135|"~     The aim of this study is use of ACTH as a predictive marker in patients of threatened preterm~     labor .~   "
137067|NCT01773122|"~     This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of dapsone in~     subjects with acne vulgaris following 28 days of dosing.~   "
137068|NCT01773109|"~     This Phase 2 study is designed to characterize the objective response rate (defined as~     complete response (CR) and partial response (PR)) of Etirinotecan pegol administered to~     subjects with metastatic and recurrent NSCLC after failure of 2nd line therapy. Up to 37~     eligible subjects will receive the investigational drug q3 weeks until they are no longer~     benefiting.~   "
137069|NCT01773096|"~     The purpose of this study is to determine whether the routine use of methylnaltrexone in the~     post-operative pediatric spinal fusion patient will decrease the incidence of constipation.~   "
137070|NCT01773083|"~     The purpose of this international multi-center double-blind randomized placebo-controlled~     trial is to determine the effect of nebulized heparin, compared to placebo, on the number of~     ventilator-free days at day 28, in burn patients with confirmed inhalation trauma requiring~     mechanical ventilation.~   "
137071|NCT01773070|"~     A follow-up study to assess resistance and durability of response to 3 experimental drugs~     ABT-450/r, ABT-267, and ABT-333 in participants who have participated in AbbVie Phase 2 or 3~     clinical studies with these agents for the treatment of chronic hepatitis C virus (HCV).~     Studies include: M11-646 (NCT01716585), M11-652 (NCT01464827), M12-746 (NCT01306617), M12-998~     (NCT01458535), M13-098 (NCT01715415), M13-099 (NCT01704755), M13-386 (NCT01563536), M13-389~     (NCT01674725)' M13-393 (NCT01685203), M13-961 (NCT01767116), M14-002 (NCT01833533), and~     M14-103 (NCT01911845).~   "
137072|NCT01773057|"~     The purpose of this study is to determine whether the computerized decision support system~     'NHGDoc' is effective in improving quality of primary care in terms of processes of care~     (e.g. prescribing behavior of physicians) as well as outcomes of care (e.g. hospital~     admissions, mortality).~   "
137073|NCT01773044|"~     Aim: The aim of this study was to compare the efficacy of pretreatment 0.5 mg/kg lidocaine~     and 0.5 mg/kg alkalinized lidocaine for prevention of propofol induced pain.~      Methods: In this double-blind, placebo controlled study, 300 adults patients ASA I or II,~     scheduled to undergo elective surgery, were randomly assigned into three groups of 100 each.~     Group L, recevied 0.05 mL/kg lidocaine (% 2 lidocaine 5 mL + 5 mL SF), Group A, 0.05 mL/kg~     lidocaine with bicarbonate ( % 2 lidocaine 5 mL + 1 mL %8,4 NaHCO3+ 4 mL SF) and control~     group received isotonic saline pretreatment in the dorsum of the hand, followed by propofol~     30 sec later. A blinded researcher assessed the patient's pain level via a four-point scale.~   "
137074|NCT01773031|"~     A prospective intra-individual study to compare the image quality of magnetic resonance (MR)~     pancreatography at 3.0 T and 1.5 T in patients with autoimmune pancreatitis.~   "
137075|NCT01773018|"~     Volitinib (HMPL-504) is a novel, highly potent and selective small molecule inhibitor of~     c-Met kinase. In preclinical studies, it demonstrated strong in vitro and in vivo activity~     against c-Met kinase and its downstream signaling targets and inhibited tumor cell growth.~     This first-in-human study is conducted to assess the maximum tolerated dose (MTD) and~     dose-limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary~     anti-tumor activity of HMPL-504 at single doses and multiple doses.~   "
137076|NCT01773005|"~     The objective of this study is to compare the effectiveness and of perioperative use of~     Caldolor alone and in combination with OFIRMEV in total knee or hip arthroplasty procedures.~   "
137077|NCT01772992|"~     Men who have sex with men (MSM) continue to be the most heavily-impacted risk group in the US~     HIV epidemic. Studies suggest that the majority of incident HIV infections among MSM are~     attributable to sex with a main male sex partner. However, HIV prevention interventions that~     target male-male couples are lacking. Because of this, Couples HIV Voluntary Counseling and~     Testing (CVCT), an intervention that has been repeatedly shown to reduce HIV transmission~     within heterosexual couples, has been adapted to US MSM couples. Additionally, novel evidence~     demonstrates that antiretroviral therapy (ART) not only reduces morbidity and mortality among~     HIV-positive persons, but also serves to reduce the risk of HIV transmission to a negative~     partner by 96%. As adherence to ART is modifiable and levels of peer support have been shown~     to increase ART adherence, this current study proposes to use CVCT combined with dyadic~     adherence counseling (CVCTPlus) to improve linkage to care, retention in care, ART~     adherence, and viral suppression among male-male couples using a cohort of 350 serodiscordant~     (one HIV(+) partner, one HIV(-) partner) couples in the greater Atlanta, Chicago, and Boston~     areas. Prospective couples (175 in each arm) will be followed for 18 months. At each visit,~     they will receive HIV testing, and both partners will complete a study survey measuring~     social and behavioral factors that may influence adherence, such as a couple's coping ability~     and their concordance of agreements regarding outside sex partners. Additionally, couples in~     the intervention arm will receive two additional sessions of Partner-STEPS.~   "
137078|NCT01772979|"~     This is a multicenter phase II study on trabectedin in advanced or recurrent ovarian cancer~     patients with BRCA mutation and BRCAness phenotype.~      The purpose of this study is to determine the feasibility in terms of objective response rate~     by RECIST version 1.1 (Complete and Partial Response [CR + PR]) with trabectedin in patients~     with BRCA1 or BRCA2 mutation carrier or BRCAness phenotype advanced ovarian cancer patients.~   "
137079|NCT01772966|"~     Eligible subjects with chronic neck pain will be randomly allocated to one of two~     intervention groups: real vs control spinal manipulation. They will receive three~     intervention sessions.~      H1: Chronic neck pain patients treated longitudinally over a series of three encounters in~     one week by random assignment to treatment group with either of the dual delivery procedures~     (Intervention 1=typical-control or Intervention 2=control-control) will have a 50% error rate~     of self-report of group allocation at exit interview.~      H2: Patients treated by the typical-control dual procedure over a typical sequence of~     encounters (3 times in one week) will show statistically significant improvement in clinical~     outcomes; defined quantitatively by visual analogue pain scale (VAS), Neck Disability Index~     (NDI), range of motion and pressure algometry; compared to those treated by the~     control-control dual procedure.~      H3: Patients stratified by 'a priori' patient expectation for treatment outcome will show no~     significant difference in self-report of group allocation or clinical outcome measures.~      A total of 372 subjects will be recruited.~   "
137080|NCT01772953|"~     This is a prospective, open-label, nonrandomized, prospective clinical trial evaluating a~     fixed regimen of treosulfan, fludarabine and low-dose total body irradiation (TBI) in~     children with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) undergoing~     allogeneic hematopoietic cell transplantation (HCT). The primary hypothesis is that HCT with~     a preparative regimen consisting of treosulfan, fludarabine and low-dose TBI will result in~     overall survival (OS) comparable to historical rates observed with conventional myeloablative~     regimens in the pediatric population. The preparative regimen will result in adequate~     incidence of neutrophil and platelet engraftment, and acceptable rates of graft-versus-host~     disease (GVHD), relapse and survival. The pharmacokinetic (PK) profile of treosulfan in~     children will be comparable to that of adults previously studied.~   "
137081|NCT01772940|"~     In resource-limited setting, concerns remain regarding the emergence of virologic failure and~     high-level drug resistance mutations (DRM) during WHO recommended first-line antiretroviral~     therapy (ART) with non-nucleoside reverse transcriptase inhibitors (NNRTI) based regimens for~     Human immunodeficiency virus 1 (HIV1) infected patients. The study hypothesis is that a~     boosted-protease inhibitor regimen has a better outcome than a NNRTI-based regimen with a low~     genetic barrier to resistance.~      The study is a randomized, multicenter, factorial trial (conducted in Congo), in treatment-~     naïve adults receiving for 96 weeks ritonavir- boosted lopinavir(LPV/r) or nevirapine (NVP)~     each in combination with tenofovir (TDF) /emtricitabine (FTC) or zidovudine (ZDV)/lamivudine~     (3TC). The primary end point is the incidence of therapeutic (clinical and/or~     virologic)failure by study week 24.~   "
137206|NCT01771302|"~     This randomized clinical study investigates the efficiency of plasma rich in growth factors~     (PRGF-Endoret) in combination with bone grafts in the healing of bone and soft tissues after~     the performance of lateral sinus floor elevation.~      The hypothesis of this study is that the use of PRGF-Endoret will produce similar bone~     formation regardless the type of bone graft.~   "
137082|NCT01772927|"~     Numeta G13% is a triple chamber bag including amino acids plus electrolytes, glucose and~     lipids, dedicated for parenteral nutrition in preterm newborn infants when oral/enteral~     nutrition is not possible, insufficient or contra indicated. The product has been registered~     in 18 countries in Europe via a decentralized procedure that ended 15th December 2010.~      The present study want to evaluate the use of Numeta 13% as standard medical prescription in~     the NICU of the university of Liege. It is a prospective, monocentric, non-interventional,~     non comparative, open-labeled data collection of record keeping, nutritional intakes from the~     bags, additional intakes as well as blood and urine biochemical markers currently evaluated~     in the NICU.~      The data will be collected only in VLBWI < 1500 g receiving Numeta G13% from day of birth~     (day 1) until parenteral nutrition (PN) decreases below 20% of the targeted intakes 2 days in~     a row as a quality control of the new solution in clinical practice.~      Indication for PN and daily prescription will follow the protocol in use in the NICU on~     behalf of the investigators~   "
137083|NCT01772914|"~     The purpose of this study is to determine whether copeptin levels are affected by food~     intake.~   "
137084|NCT01772901|"~     The investigators will conduct a brief educational intervention to pregnant women who have~     not yet received the influenza vaccine in this pregnancy to improve the uptake of seasonal~     influenza vaccine.~   "
137085|NCT01772888|"~     Study aims: The primary aim is to determine whether chewing efficiency, determined by a~     two-colour mixing ability test, and maximum bite and lip force decrease in ALS patients.~   "
137086|NCT01772875|"~     In patients with advanced multiple sclerosis, permanent urinary catheters are often used to~     manage the urinary incontinence and bladder emptying problems. These catheters will lead to~     urinary tract infection, blocking of the catheter etc.. Especially infections with certain~     bacteria such as proteus, enterobacteriaceae and ESBL producing enterobacteriaceae and~     pseudomonas can pose a problem for the hospital infection control and for the patient.~      This study wants to evaluate the potential role of regular bladder lavage with saline, a~     solution of betadine, an acid solution of acetic acid and of URotainer Twin Suby G ( Braun)in~     the decontamination of these bladders and the prevention of clinically relevant urinary tract~     infections.~   "
137087|NCT01772862|"~     The purpose of this study is to determine whether early rehabilitation intervention including~     individualized physical training and social activities with a class mate at two weeks~     intervals at the ped.onc. center will increase children with cancer's level of physical~     performance~   "
137088|NCT01772849|"~     The purpose of this study is to determine whether early rehabilitation intervention including~     educational and social activities with a class mate at two weeks intervals at the ped.onc.~     center will increase children with cancer's level of education performance.~   "
137089|NCT01772836|"~     RPX7009 (beta-lactamase inhibitor) is being studies in combination with a carbapenem biapenem~     to treat bacterial infections, including those due to multi-drug resistant bacteria.~   "
137090|NCT01772823|"~     Approximately 200 HIV-uninfected young men who have sex with men (YMSM) at high risk of~     acquiring HIV infection, ages 18-22 years, inclusive, will be recruited across all~     participating Adolescent Medicine Trials Units (AMTU). The behavioral intervention will be~     assigned at the level of the site, which include Many Men, Many Voices (3MV) and Personalized~     Cognitive Counseling (PCC). Subjects will first complete the behavioral intervention offered~     at their respective site and then be provided with open label emtricitabine (FTC)/tenofovir~     (TDF) (Truvada®) as PrEP. Behavioral and biomedical data will be collected at baseline and 0,~     4, 8, 12, 24, 36 and 48 weeks. Any subjects who become HIV infected during the course of the~     study will be discontinued from the study agent and followed for an additional 24 weeks after~     the study visit at which HIV infection is confirmed. Those subjects who meet specific bone or~     renal criteria at the Week 48 visit or the 24-Week HIV Seropositive visit will be followed~     for an additional 48 weeks in the Extension Phase to monitor longer-term outcomes of~     potential concerns.~   "
137091|NCT01772810|"~     This is a safety study of human spinal cord-derived neural stem cell (HSSC) transplantation~     for the treatment of chronic spinal cord injury.~   "
137092|NCT01772797|"~     The primary purpose of the study is to estimate the maximum tolerated dose of the combination~     of LDK378 and AUY922. This study will assess the safety, tolerability, pharmacokinetics and~     preliminary evidence of anti-tumor activity of the combination of LDK378 and AUY922 in~     ALK-rearranged non-small cell lung cancer.~   "
137093|NCT01772784|"~     Epidemiological studies suggest dietary (poly) phenols decrease the risk of death from~     cardiovascular diseases. (Poly)phenol-rich foods include fruits and vegetables as well as~     tea, coffee, red wine, and chocolate. The aim of the present study is to investigate whether~     endothelial function is altered by ingestion of phenolic acids. Moreover, the investigators~     will evaluate the effect of phenolic acids on blood pressure and platelet adhesion.~   "
137094|NCT01772771|"~     The main goal of this study is to perform standardized testing of tumor tissue to learn which~     genes are mutated (have changed) to provide personalized cancer therapy options to patients~     at MD Anderson. Your doctor may be able to use testing information on your tumor to identify~     clinical trials that may be most relevant to you.~      Another goal of this laboratory research study is to learn how often different genes mutate~     in patients with different cancers. Researchers will also use the information learned from~     this study to develop a database of the different kinds of mutations in cancer-related genes.~      Researchers also hope to better understand how mutations in cancer-related genes may affect a~     patient's response to different therapies. Researchers can use this information to select~     specific therapies for future patients that are more likely to be effective.~   "
137107|NCT01772602|"~     The purpose of this registry is to (A) better describe the incidence and prevalence of~     Amyotrophic Lateral Sclerosis (ALS) in the United States;(B) examine appropriate factors,~     such as environmental and occupational, that may be associated with the disease; (C) better~     outline key demographic factors (such as age, race or ethnicity, gender, and family history~     of individuals who are diagnosed with the disease) associated with the disease; and (D)~     better examine the connection between ALS and other motor neuron disorders that can be~     confused with ALS, misdiagnosed as ALS, and in some cases progress to ALS.~   "
137207|NCT01771289|"~     The purpose of this study was to evaluate the safety and efficacy of neoadjuvant concurrent~     chemoradiation with weekly docetaxel/cisplatin in patients with resectable IIIA-N2 NSCLC.~   "
137095|NCT01772758|"~     Perhaps one of the most disturbing aspects of Cystic Fibrosis (CF) is the associated~     premature death. Oxidative stress has been observed in patients with CF and exercise~     intolerance has been shown to predict mortality in patients with CF, regardless of how~     healthy their lungs are. A critical barrier to improving the quality of life and longevity in~     patients with CF is our lack of knowledge regarding the different reasons why patients with~     CF cannot exercise to the level of their peers. We have collected preliminary data to support~     our central hypothesis that oxidative stress contributes to the impairment in blood vessel~     function at rest and during exercise which ultimately oxygen transport and delivery resulting~     in exercise intolerance. Exercise is therapeutic medicine for patients with CF and this~     investigation represents a major breakthrough in the approach to begin understanding the~     physiological mechanisms which contribute to exercise intolerance in these patients.~   "
137096|NCT01772745|"~     Laparoscopic techniques have allowed surgeons to perform complicated intrabdominal surgery~     with minimal trauma. Laparoscopic cholecystectomy has been recognized since 1987 as the gold~     standard procedure for gallbladder surgery. Single incision laparoscopic surgery (SILS) was~     developed with the aim of reducing the invasiveness of conventional laparoscopy. In this~     study we aimed to compare results of SILS cholecystectomy and three port conventional~     laparoscopic (TPCL) cholecystectomy prospectively~   "
137097|NCT01772732|"~     The primary objective is to assess the safety and tolerability of multiple doses of Simotinib~     Hydrochloride in NSCLC patients. The secondary objective is to determine the pharmacokinetic~     (PK) profile and explore the preliminary anti-tumor activity.~   "
137098|NCT01772719|"~     The purpose of this study is to examine the effect of simvastatin and zoledronic acid on~     M-protein and/or free light chains when added to conventional chemotherapy for the treatment~     of multiple myeloma patients.~   "
137099|NCT01772706|"~     The purpose of the study is to assess in a randomized, double blind, controlled,~     multi-center, phase III study, the efficacy of low level diode laser (100 MW, 658 Nm), in the~     prevention and treatment of radiochemotherapy-induced mucositis for stage III and IV head and~     neck carcinomas.~   "
137100|NCT01772693|"~     This is a feasibility study to evaluate the safety and initial effectiveness of unilateral~     ExAblate thermal ablation of the Vim thalamic nucleus of subjects suffering from~     medication-refractory, idiopathic, tremor-dominant PD, using the ExAblate Transcranial system~     compared to a Sham Vim thalamotomy procedure.~      Data will be collected to establish the basic safety of this type of treatment as the basis~     for later studies that will evaluate its full clinical efficacy. The Sham treatment data will~     be used to evaluate placebo effect from treatment.~   "
137101|NCT01772680|"~     The primary aim of this study is to measure zinc status and related proteins in patients with~     Thalassemia who have or do not have diabetes. The secondary aim will be to explore the effect~     of zinc supplementation on glucose metabolism in patients with thalassemia.~   "
137102|NCT01772667|"~     There is evidence that an inpatient pulmonary rehabilitation of 3 weeks improves exercise~     capacity and quality of life in patients with idiopathic pulmonary fibrosis. However, there~     are no data available regarding long-term effects of this multimodal program. The aim of this~     study is to investigate the long-term impact of a rehabilitation program 3 month after~     finishing on exercise capacity and physical activity.~   "
137103|NCT01772654|"~     This study will evaluate a type of Magnetic Resonance Imaging (MRI) sequence called arterial~     spin labeling (ASL). The investigators hope that ASL can better localize areas of the brain~     (lesions) that cause epilepsy. This type of MRI does not require contrast, does not use any~     radiation, and adds on 4 minutes to the routine MRI that is done for patients with epilepsy.~      The study hypothesis is that in patients with refractory epilepsy, Arterial Spin Labeling~     (ASL) MRI will show areas of abnormality in the brain to the same degree as single-photon~     emission computerized tomography (SPECT) and positron emission tomography (PET) studies.~   "
137104|NCT01772641|"~     This study has three main aims. Aim 1: To provide initial data on the efficacy of combined~     Scheduled Gradual Reduction (SGR) and Varenicline (VN) for smoking cessation, by assessing~     abstinence and levels of smoking at 2 time points (4 and 12 weeks post quit). Aim 2: To~     explore the possibility that SGR+VN will be particularly efficacious among smokers with~     higher background levels of Cue Reactivity (CR), as assessed at the start of the study, using~     a classic experimental smoking CR paradigm. Aim 3: To explore possible mechanisms underlying~     the effects of SGR+VN, by assessing potential mediators (i.e., self-efficacy, cue-induced~     cravings) of treatment effects.~   "
137105|NCT01772628|"~     The main objective of the study was to develop a novel intervention method which could reduce~     the spread of Sexually Transmitted Infections (including HIV) and unwanted pregnancies by~     improving parent-child communication using schools as gateways.~      It was done in 22 public day and mixed secondary schools in both Kampala and Wakiso~     districts. The study employed a cluster randomized controlled trial experimental design.~     Eligible schools were purposively selected and stratified into urban, peri-urban and rural.~     The schools were then matched into pairs for potential confounding variables such as religion~     and gender. In total, 11 schools were randomly allocated to the intervention and an equal~     number of schools to the comparison arms of the study.~      A questionnaire was administered to students at baseline and post-intervention. This~     questionnaire was validated in test re-test on approximately 200 S1 students from 2 schools~     that did not participate in the intervention nor the comparison arm. A parents'/guardians'~     questionnaire was also administered both at baseline then at post intervention. This~     questionnaire was also pre-tested among approximately 200 parents of S1 students who~     participated in the test re-test. The results of the pre-test were used to finalize the~     questionnaire. To increase the extent to which questions were understood, the English~     versions of questionnaires were translated into one of the widely spoken local language~     Luganda.~   "
137106|NCT01772615|"~     Purpose: The purpose of the study is to investigate if treatment with ciprofloxacin for one~     week followed by therapy with E. Coli Nissle (EcN) for seven weeks can influence disease~     activity among ulcerative colitis patients with disease flare-ups compared to placebo~     controls.~   "
137208|NCT01771276|"~     The purpose of this study is to help find out more about how the Primary Obesity Surgery~     Endoluminal (POSE) procedure makes patients feel less hungry and fuller faster, leading to~     weight loss. In this study, USGI Medical wants to see if stomach emptying and~     gastro-intestinal hormone levels change after a POSE procedure with an increased (as compared~     to typical) number of anchors placed.~   "
137108|NCT01772589|"~     There have been considerable efforts to control rising health care costs. One of the more~     recent developments is the practice of reprocessing single use medical devices. This practice~     has been shown to provide considerable savings for health care payers. Medical devices have~     been reprocessed in a number of different medical fields including Orthopaedic Surgery. One~     of the devices that has been reprocessed are the Precision Saw Blades from Stryker Inc. These~     saw blades are used during Total Knee Arthroplasty (TKA) surgery. The reprocessed Precision~     saw blades are Health Canada approved and are available at Capital Health.~      Beyond the benefits to the environment and cost savings, the investigators do not know if the~     reprocessed saw blades work better, work worse or the same as non reprocessed saw blades.~     This study is designed to determine if the reprocessed saw blades used during a TKA work as~     well as a new saw blade.~   "
137109|NCT01772576|"~     The objective of this study is to gather data to establish the chronic safety, performance~     and effectiveness of the RELIANCE 4-FRONT™ Active Fixation Defibrillation Leads.~   "
137110|NCT01772563|"~     The primary objective of the present study is to investigate the influence of~     co-administration of itraconazole and volasertib on the pharmacokinetic profile of volasertib~     without co-administration of itraconazole. Secondary objectives are to investigate safety,~     tolerability and preliminary therapeutic effects following intravenous administration of~     volasertib.~   "
137111|NCT01772550|"~     The purpose of this study is to compare multidetector computed tomography (CT) image quality~     following peripheral venous high pressure injection of iodinated intravenous contrast media~     between a 20 gauge (GA) fenestrated, intravenous catheter (BD Nexiva™ Diffusics™) and an 18~     GA non-fenestrated, intravenous catheter.~      In the contrast enhanced CT procedure (CECT), a machine (power injector) is used to rapidly~     deliver contrast agent to an individual's circulatory system. The contrast allows for greater~     differentiation of tissues in images of the area of interest, affording a better opportunity~     to visually assess the area and hence make a more accurate diagnosis.~      CECT often requires a high rate of contrast flow (≥ 5 mL/sec) through the IV catheter to~     provide sufficient contrast for an acceptable image. Typically an 18 GA IV catheter is~     required to achieve these high flow rates; however, often the patient does not have a vein~     that will accommodate this large size catheter. The BD Nexiva™ Diffusics™ IV catheter is~     designed to deliver a higher flow rate than a conventional catheter of the same gauge by~     incorporating fenestrations (small openings) near the tip of the catheter that allow fluid to~     exit the catheter in addition to that which normally exits through the main opening at the~     tip of the catheter.~   "
137112|NCT01772537|"~     Alzheimer's disease represents a growing public health problem in developed countries.~     Although the pathogenesis is not clearly defined, accumulation of extracellular amyloid,~     neurofibrillary tangles and neuronal loss are the hallmarks of Alzheimer's disease. The~     effect of anesthetic agents on changes in these proteins in humans is not well characterized,~     but in-vitro evidence suggests that anesthetic agents can accelerate potential pathogenic~     mechanisms, such as increasing amyloid formation or rates of apoptosis in cultured cells and~     increasing amyloid levels in mice. Human data on the effect of anesthetic agents on amyloid~     and tau proteins is limited to a small series of 11 patients and showed a significant~     increase in tau levels after exposure to anesthetics. In this study the investigators propose~     to measure CSF and serum biomarkers in a population of patients with normal CSF dynamics, who~     are undergoing surgery for repair of a thoracoabdominal aneurysm. The investigators will also~     obtain preliminary data on whether changes in CSF levels of these proteins are associated~     with postoperative delirium or cognitive change.~   "
137113|NCT01772524|"~     The purpose of this study is to assess the safety, pharmacokinetics and efficacy of a single~     dose of ALD403 in the prevention of migraine headache in frequent episodic migraineurs for 24~     weeks.~   "
137114|NCT01772511|"~     The purpose of this study is to assess patients' understanding of clinical trials and to help~     researchers understand which areas of the informed consent need better explanation for future~     cancer clinical trial patients.~   "
137115|NCT01772498|"~     This study is designed to take a first step toward testing the efficacy and acceptability of~     heart rate variability biofeedback (HRVB) as a means of ameliorating psychological distress~     in survivors of Primary Brain Tumour (PBT). HRVB is a biofeedback approach that provides~     clients with real time feedback about their heart rate variability (HRV) as a means of~     teaching them how to breathe in a specific, therapeutic manner.~      More specifically, this study has been designed to test several hypothesises. Each hypothesis~     is based on the prediction that, in a sample of psychologically distressed PBT survivors, a~     course of 8 HRVB sessions will demonstrate:~        -  statistically significant reductions in levels of depression~        -  statistically significant reductions in levels of anxiety~        -  statistically significant increases in resting HRV~        -  that reductions in anxiety and depression will be significantly, negatively correlated~          with increases in resting HRV~        -  that the HRVB will be viewed as an acceptable intervention by the participants~      In addition to the hypothesises stated above, the study will also investigate in a discovery~     oriented manner if the HRVB intervention will have positive impacts on the participants:~        -  levels of sleep impairment~        -  levels of pain~   "
137116|NCT01772485|"~     This project shall rigorously evaluate the effectiveness of a novel, neuroplasticity-based~     internet-deliverable cognitive training program, which specifically targets the treatment of~     core cognitive dysfunctions observed in adolescents with Attention Deficit Hyperactivity~     Disorder (ADHD/ADD), to be tested in a clinical population in New Delhi, India.~   "
137117|NCT01772472|"~     This 2-arm, randomized, open-label study will evaluate the efficacy and safety of trastuzumab~     emtansine versus trastuzumab as adjuvant therapy in patients with HER2-positive breast cancer~     who have residual tumor present in the breast or axillary lymph nodes following preoperative~     therapy. Eligible patients will be randomized to receive either trastuzumab emtansine 3.6~     mg/kg or trastuzumab 6 mg/kg intravenously every 3 weeks for 14 cycles. Radiotherapy and/or~     hormone therapy will be given in addition if indicated.~   "
137231|NCT01770977|"~     Light-emitting diode Therapy (LEDT) has been used to improve human muscle performance in~     experimental models and human researches. Now, the investigators used LEDT to increase muscle~     performance of professional athletes with high performance.~   "
137118|NCT01772459|"~     Research has shown that questionnaires completed on the internet have the potential to~     provide more complete and honest data with fewer errors in a more efficient manner than~     questionnaires completed using the paper and pencil format. Despite the numerous advantages~     of internet-administered questionnaires, it is important to make sure that the internet~     questionnaires will yield comparable results to the well-established paper and pencil~     versions. No one has studied internet administration of scoliosis specific questionnaires in~     adolescents with scoliosis. The investigators will test whether the internet administration~     of scoliosis questionnaires is as reliable as the traditional paper and pencil version. The~     investigators predict that the internet-administered questionnaire will provide the same~     reliability as the paper-administered questionnaires.~   "
137119|NCT01772446|"~     Introduction: The Spanish Society of Family and Community Medicine, started the Program of~     Preventive Activities and Health Promotion, which generates periodic recommendations of~     preventive methods based on scientific evidence. In the last update it has become evident the~     need of modifications to adapt the program to modern times and focuses on improving~     accessibility and offering more flexible responses to users of the program. In this sense,~     the mobile phone technology could be useful, specifically the messaging service to remind~     patients their appointments and increase attendance rates. Main objective Compare the~     percentage of patients in the intervention group compared with the control group who achieved~     a figure of HbA1c <7% in 2013.Design: single blind Randomized Clinical Trial. Study~     population: Patients with diabetes with or without hypertension or lipid metabolism disorder,~     over 18 years, belonging to the Public Health System of Basque Country (primary care) meeting~     the inclusion / exclusion criteria. Sample size: 238 patients (119 per arm) to detect a~     difference of 16% in the percentage of patients with HbA1c lower than 7% between groups:~     Short Messages Standard (SMS) group: Mobile messages reminding the next review of Papps.~     Control group: Routine clinical practice. Statistical analysis: The relationship between the~     intervention received and the main variable (compliance with preventive activities at 12~     months) were analyzed using a logistic regression model.~   "
137120|NCT01772433|"~     This study is intended to evaluate the effect of olive oil phonophoresis on chronic law back~     pain in female athletes.~   "
137121|NCT01772420|"~     This phase II trial studies how well lenalidomide and eltrombopag olamine works in treating~     patients with symptomatic anemia in low or intermediate myelodysplastic syndrome.~     Lenalidomide may stimulate the immune system in different ways and stop cancer cells from~     growing. Eltrombopag olamine may increase the number of white blood cells and platelets found~     in bone marrow or peripheral blood. Giving lenalidomide and eltrombopag olamine may be an~     effective treatment for myelodysplastic syndrome.~   "
137122|NCT01772407|"~     The primary goal of this study is to compare in the long-term costs of laparoscopic or open~     right colectomy in patients sustaining a colon cancer controling for the carcinologic~     equivalence of the two surgical strategies. The secondary goals to compare long-term~     mortality, morbidity as well as quality of life of the two groups.The present study is an~     prospective multicentric observational trial taking into account the usual surgical strategy~     of every centers~   "
137123|NCT01772394|"~     Clinicians from the Maudsley (IoP, London, UK) have specifically tailored a cognitive~     remediation therapy (CRT) for treating Anorexia Nervosa (AN). It is an intensive manualised~     training cognitive therapy which addresses the difficulties in flexibility and holistic~     processing that have been incriminated in AN. CRT has been found to improve AN's~     neuropsychological functioning and short term outcome. To our knowledge, no French speaking~     country has tested its effectiveness. Moreover, the question whether it is efficient for both~     anorexic restrictive and anorexic binge-purging patients remains unanswered.~      The aim of the present study is to determine if CRT in AN adolescents and young adults has a~     favourable impact on cognitive functioning and clinical status. We will also explore whether~     the impact of CRT is similar in both anorexic restrictive and binge-purging subtypes. There~     will also be an Historical Control Group of patients, sixty, who received traditional medical~     interventions in a specialized inpatient unit for eating disorders (i.e., EVHAN study).~   "
137124|NCT01772381|"~     Introduction: Babies born at term by elective caesarean section (CS) and before onset of~     labor are more likely to develop respiratory complications than babies born vaginally. In~     developing countries resources are scarce and it is difficult to provide expensive treatments~     as neonatal care.~      Aim of the Work: To assess the effect of prophylactic dexamethasone administration before~     elective cesarean section at term in reducing neonatal respiratory complications.~      Patients and methods: 600 women were included in the study and were planned to have elective~     caesarean section. 300 received dexamethasone 12 mg twice, 12 hours apart 48 hours before~     delivery. 300 patients were the control group.~      The outcomes were: incidence of admission to neonatal intensive care unit (NICU), incidence~     of transient tachypnea of newborn (TTN), the incidence of respiratory distress syndrome (RDS)~     and the need for mechanical ventilation.~   "
137125|NCT01772368|"~     The primary objective of this study is to evaluate the dose response, efficacy, and safety of~     4 different doses of salmeterol Spiromax (6.25, 12.5, 25, and 50 mcg) each combined with a~     fixed dose of fluticasone propionate (100 mcg) delivered as Fluticasone/Salmeterol Spiromax®~     Inhalation Powder (FS Spiromax) when administered as a single dose in subjects 12 years of~     age and older with persistent asthma.~   "
137126|NCT01772355|"~     Core needle biopsy of orbital mass lesions with a semiautomated needles is a safe procedure~     that provides a sufficient amount of tissue material for standard histological and~     immunohistochemical analysis and can be an alternative or supplement to fine needle~     aspiration biopsy~   "
137127|NCT01772342|"~     Many individuals with chronic lung disease have night time symptoms that disrupt their sleep.~     The purpose of this study is to determine the effects of an air purifying device (PureNight,~     Halo Innovations, Minneapolis, MN) on sleep disruptions measured by a sleep watch~     (actigraph) and individual perception of sleep quality.~   "
137232|NCT01770964|"~     The difference between active treatment and placebo in a clinical trial of an analgesic~     appears to depend on a variety of factors other than the actual efficacy of the drug itself,~     including various aspects of study design and conduct. One potential such factor is how~     information about the study is presented to research staff and patients. The purpose of this~     study is to examine the impact of different presentations of information on the difference~     between pregabalin and placebo observed in a clinical trial in patients with painful diabetic~     neuropathy.~   "
137128|NCT01772329|"~     The investigators propose a randomized controlled trial to evaluate the effects of treatment~     intended to reduce pain catastrophizing among patients reporting high pain catastrophizing~     prior to total knee replacement(TKR), total hip replacement(THR), or shoulder surgery in an~     effort to thereby reduce the incidence of persistent post-surgical pain (PPP) and enhance~     physical function at 3-months post-surgery. Preemptive treatment aimed at a known predictor~     of PPP following total knee replacement is highly innovative and have potentially high impact~     for public health. Cognitive therapy is a well-tolerated modality among chronic pain patients~     with few if any side effects. Cognitive therapy (CT) represents an inexpensive method that~     could greatly reduce suffering and costly post-surgical pain management for high risk TKR~     patients.~   "
137129|NCT01772316|"~     This multicenter, open-label, single arm, long-term extension study will evaluate the safety~     and efficacy of RoActemra/Actemra (tocilizumab) in participants with moderate to severe~     rheumatoid arthritis who have completed the 97-week WA22762 or the 96-week NA25220 core~     study. Participants will receive RoActemra/Actemra 162 milligram (mg) subcutaneously weekly~     (for participants entering from WA22762) or every two weeks (for participants entering from~     NA25220) for 96 weeks, with telephone call follow-up visits at Weeks 100 and 104.~   "
137130|NCT01772303|"~     This multicenter, prospective, open-label, outpatient study will assess the safety and~     efficacy of HO/03/03 10µg applied topically once daily for up to 24 weeks in up to 100~     subjects with Hard to Heal documented chronic wounds of various etiologies (pressure ulcers,~     diabetic ulcers, post operational wounds surgical incisions ulcers of rheumatoid arthritis~     and trauma wounds) of at least 4 weeks documentation.~   "
137131|NCT01772290|"~     This randomized, open-label, 4-arm, multiple-dose study will evaluate the effect of~     coadministration of a protein pump inhibitor, an inhibitor of P-glycoprotein and CYP3A4, or~     an inhibitor of CYP2C9 on the pharmacokinetics of vismodegib in healthy female subjects of~     non-childbearing potential. Subjects will be randomized to receive multiple oral doses of~     vismodegib, alone or in combination with multiple oral doses of either rabeprazole,~     itraconazole or fluconazole. Anticipated time on study treatment is up to 11 days.~   "
137132|NCT01772277|"~     To assess the efficacy and safety of local application of intraoperative mitomycin C (MMC) at~     osteotomy site in endoscopic dacryocystorhinostomy(EN-DCR).~   "
137133|NCT01772264|"~     The most notable tolerability finding from these multiple dosing studies has been the~     occurrence of mild to moderate rash at doses of 450 mg BID and 600 mg BID. Based upon this~     finding, the current four week study is designed to examine whether a slow titration regimen~     up to a lower maintenance dose of 450 mg BID is able to reduce the incidence of rash.~   "
137134|NCT01772251|"~     Diabetes mellitus (DM) is a chronic disease of carbohydrate, fat, and protein metabolism~     caused by an absolute or relative deficiency of insulin, an anabolic hormone. The current~     methods of insulin therapy for diabetic patients are multiple daily injection therapy and~     continuous subcutaneous insulin infusion with an external pump. This rout of administration~     may lead to hyperinsulinemia as insulin is administered in a non physiological way, targeting~     mainly extra hepatic tissues (muscle, fat).~      A method of providing insulin without the need for injections has been a goal in drug~     delivery.~      Oshadi Drug Administration Ltd. has developed oral carrier for proteins based on biochemistry~     and quantum theory of biochemical reactions. The carrier enables the absorption of proteins~     from the gastrointestinal tract in their full structure. Oshadi has also developed the Oshadi~     Icp - insulin, proinsulin and C-peptide in Oshadi carrier, administrated orally. This study~     was design in order to evaluate the safety and feasibility of multiple administration of~     Oshadi Icp~   "
137135|NCT01772238|"~     The objective of this study was to confirm if two formulations of amoxicillin and clavulanic~     acid (suspension) are bioequivalent.~      Test product was AUGMENTIN 12H (400 mg Amoxicillin and 57 mg Clavulanic acid/ 5 ml; Glaxo~     Wellcome France) and reference product AUGMENTIN 12H (400 mg Amoxicillin and 57 mg Clavulanic~     acid/ 5 ml; GlaxoSmithKline Mexico). The single dosage was 10 ml of suspension.~      The study was prospective, open-label, randomized, crossover, single dose, with 02~     treatments, 02 sequences and 02 periods, under fasting conditions.~      The population was composed of 35 healthy volunteers, both genders, adults between 18-50~     years.~      The comparative bioavailability of the two formulations was evaluated based in statistical~     comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations~     in blood.~   "
137136|NCT01772225|"~     The aim of this observational study is to identify and quantify the humanistic and economic~     burden of illness of patients with complete resection (no residual disease) of stage IB-IIIA~     NSCLC in three European countries (France, Germany, and the United Kingdom [UK]). Data~     collection will be conducted through patient medical record abstraction and patient survey.~   "
137137|NCT01772212|"~     The objective of this study was to confirm if two formulations of terbinafine (tablets) are~     bioequivalent.~      Test product was Xilatril® 250 mg (Laboratorios Dermatológicos Darier) and reference product~     Lamisil® 250 mg (Novartis). One tablet was the single dosage.~      The study was prospective, open-label, randomized, crossover, single dose, with 02~     treatments, 02 sequences and 02 periods, under fasting conditions.~      The population was composed of 30 healthy volunteers, both genders, adults between 18-50~     years.~      The comparative bioavailability of the two formulations was evaluated based in statistical~     comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations~     in blood.~   "
137157|NCT01771952|"~     The purpose of this study is to determine how safe a knee injection called Synvisc-One® is in~     patients with a condition called chondromalacia patella and how well in works in treating the~     condition.~      Chondromalacia patella is a common cause of kneecap pain or front knee pain. Often called~     Runner's Knee, this condition often affects young, otherwise healthy individuals.~      Chondromalacia is due to irritation of the undersurface of the kneecap. The undersurface of~     the kneecap, or patella, is covered with a layer of smooth cartilage. This cartilage normally~     glides effortlessly across the knee during bending of the joint. In some individuals, the~     cartilage on the undersurface of the knee cap becomes irritated and soft, resulting in pain.~     Potential treatments for this condition include rest, injections (numbing or~     anti-inflammatory medications to reduce swelling and pain), and/or guided strengthening~     exercises which may help reduce pain.~      Other Treatments are being evaluated. This study is about Synvisc-One® an experimental device~     that has been approved by the Food and Drug Administration (FDA) for the treatment of pain in~     osteoarthritis (OA) of the knee in patients who have failed to respond to treatments that do~     not involve drugs or surgery and simple pain medication such as acetaminophen. Synvisc-One®~     is a gel-like substance that, when injected into a joint, acts to lubricate and cushion the~     joint. Synvisc-One® is made from hyaluronan, which is a molecule that is found normally in~     joint fluid.~      Synvisc-One® has not been proven to be safe or helpful in patients with chondromalacia~     patella (cartilage irritation or softening of the undersurface of the 'knee cap'). So far,~     this drug/device has been given to over 10,000 people who have knee pain (due to~     osteoarthritis) and has been proven safe and effective in patients with moderate to severe~     pain due to knee joint osteoarthritis.~   "
137138|NCT01772199|"~     This is a randomized, parallel group, placebo-controlled study designed to assess whether~     GSK239512 can enhance lesion remyelination in subjects with Relapsing Remitting Multiple~     Sclerosis (RRMS). Subjects with RRMS on stable background treatment with either Avonex~     (Interferon-beta1a) or Copaxone (Glatiramer Acetate) are eligible to participate. Subjects~     will be randomized in a 1:1 ratio between placebo and GSK239512, and will continue to be~     managed with their current standard of care therapy (Copaxone or Avonex). The total treatment~     period is 48 weeks, including a standard 4 week titration period and 44 week maintenance~     treatment period (which could be adapted to a 5-week titration and 43 week maintenance~     period, if needed). Titration doses start at 10 micrograms (mcg) and increase up to 80 mcg~     (10 mcg first week, 20 mcg second week, 40 mcg third week, 80 mcg fourth week). Subjects will~     be titrated to the maximum tolerated dose with the objective of titrating to the highest dose~     (80 mcg GSK239512), whenever possible, based on investigator judgement of tolerability. The~     post-treatment follow-up period will be a minimum of 2 weeks in duration following the end of~     treatment at Week 48 or early withdrawal, as appropriate.~   "
137139|NCT01772186|"~     Background and purpose: Freezing of gait (FOG) is one of the most disabling motor symptoms in~     people with Parkinson's disease (PD), and closely associates with postural instability and~     fall. Previous studies had shown that somatosensory stimulation could induce weight shift,~     and this is probably helpful for gait reinitiation. Therefore, the investogators propose a~     two-year project to develop a wearable device, the somatosensory stimulation system (SSS),~     which monitors gait real-time and provide somatosensory stimulation once FOG episodes~     detected. And the investigators test the effects of this SSS device on FOG, fall, and walking~     function.~      Methods: The first-year study is to build and validate this wearable SSS device. The~     customized device has sensor part and stimulator part; the former is an inertial sensor~     module to detect FOG episodes, and the latter is a microvibrator-embedded insole to~     facilitate weight shift and gait reinitiation. To validate the device, patients with FOG are~     recruited and conduct FOG-provoking tasks during their medication OFF or late On state in~     a laboratory setting. The investigators test if the SSS device could facilitate lateral~     weight shift and help gait reinitiation, as well as the reliability. The second-year study is~     to test if the SSS device stands a long-term, daily wearing basis, and to evaluate its effect~     on FOG, fall, and walking function. The investigators recruit PD patients with FOG, and~     randomly assign them into the experimental and control groups. Both groups wear the SSS~     device during the daytime for ten weeks, and the stimulator part is turned on during the~     first six weeks (intervention phase) only in the experimental group. The stimulator part is~     then kept off during the last four weeks (follow-up phase) in both groups. The effect of the~     SSS device is evaluated by the outcomes including FOG severity, fall and walking function,~     which are measured prior/after the intervention phase and after the follow-up phase.~      Clinical relevance: This project tempts to combine real-time gait analysis with~     somatosensory-induced postural readjustment, and using this novel approach to improve FOG and~     fall in people with PD. The results of this projects might also provide an objective,~     long-term assessment tool to measure the FOG phenomenon for clinical and research fields.~   "
137140|NCT01772173|"~     Diabetic complications are an important source of blindness and mortality among Veterans.~     Their occurrence is unpredictable because of the highly variable effect of factors such as~     weight, diet and exercise. Improved prediction of diabetes complications has the potential to~     improve the care for Veterans with diabetes, especially if this can be done without any extra~     effort for the Veterans or their caretakers. All Veterans with diabetes in VHA are required~     to undergo annual retinal photography to screen for current diabetic retinopathy. The~     investigators have recently developed an automated, precise, fast, novel tool for measuring~     retinal vessels in these images. Manual measurement of retinal vessels has shown that these~     can predict future -not current- development of hypertension and also diabetic retinopathy.~     If the investigators can confirm that their tool can flag those Veterans at increased risk~     for developing these diabetes complications, this will allow earlier intervention and~     prevention. Because the tool only uses the images that are being taken anyway, there is no~     extra effort for either the Veteran or VA staff.~   "
137141|NCT01772160|"~     The purpose of this study is to collect data on the incidence, complications, economic burden~     and impact on the quality of life in adults aged ≥ 50 years with HZ disease in Italy.~   "
137142|NCT01772147|"~     The purpose of this 12 week study is to evaluate the effects of the addition of umeclidinium~     bromide (62.5mcg) once-daily to fluticasone propionate (250/50mcg) twice-daily and~     umeclidinium bromide (125mcg) once-daily to fluticasone propionate (250/50mcg) twice-daily~     with placebo when added to fluticasone propionate (250/50mcg) twice-daily on lung function,~     COPD-related health status assessments and safety in COPD subjects.~   "
137143|NCT01772134|"~     The purpose of this 12 week study is to evaluate the effects of the addition of umeclidinium~     bromide (62.5mcg) once-daily to fluticanse propionate/salmeterol (250/50mcg) twice-daily,~     umeclidinium bromide (125mcg) once-daily to fluticanse propionate/salmeterol (250/50mcg)~     twice-daily versus placebo to fluticanse propionate/salmeterol (250/50mcg) twice-daily on~     lung function, COPD-related health status assessments and safety in COPD subjects.~   "
137144|NCT01772121|"~     This study will define the substantial disease burden associated with viral hepatitis in~     India, and provide a foundation to understand the host and viral determinants of disease~     pathogenesis that may ultimately impact treatment decisions and outcome~   "
137145|NCT01772108|"~     This trial is a randomized study of the MitraClip device in heart failure patients with~     clinically significant functional mitral regurgitation. A hierarchical composite of all-cause~     mortality and recurrent heart failure hospitalizations is hypothesized to occur at a lower~     rate with the use of the MitraClip device in addition to optimal standard medical therapy~     compared to optimal standard of care therapy alone.~   "
137158|NCT01771939|"~     The purpose of the study is to evaluate the difference in Early Treatment Diabetic~     Retinopathy Study (ETDRS) visual acuity, oct retinal thickness and microperimetry in 2 groups~     of 30 eyes each affected by idiopathic epiretinal membranes that underwent~     phacoemulsification and 25G pars-plana vitrectomy with internal limiting membrane (ILM)~     peeling (Group 1) versus phacoemulsification only (Group 2), with a follow-up length up to 5~     years.~   "
137159|NCT01771926|"~     The investigators hypothesize that consumption of potatoes is a healthy adjunct to lifestyle~     intervention in overweight and obese glucose intolerant adults. We will evaluate the effects~     of the consumption of potatoes (high or low resistant starch) vs. commonly consumed~     carbohydrate sources on glucose tolerance; and ( the extent to which potato consumption~     alters markers of lipid metabolism and inflammation in the context of a lifestyle~     intervention program.~   "
137160|NCT01771913|"~     The purpose of this study is to investigate if there is a relationship between the take of~     fat grafts with and without ADSCs and the presence of specific surface markers on the cells~     of the stromal vascular fraction.~   "
137233|NCT01770951|"~     The objective of this retrospective trial is to assess safety and efficacy of eculizumab in~     aHUS patients treated outside of an Alexion-sponsored controlled clinical trial.~   "
137146|NCT01772095|"~     In 1906, Dr. Alois Alzheimer first described the disease that later took his name. Today, 100~     years later, 24 million people worldwide suffer from Alzheimer's disease or other dementias.~      The term 'dementia' is clinical and is used to describe brain disorders that cause decline in~     mental functions, memory first and then speech, judging and overall behavior. Alzheimer's~     disease is by far the most common form of dementia, followed by vascular dementia, dementia~     with Lewy, the frontotemporal dementias etc.~      In Greece there are 141,000 patients with dementia. With increasing life expectancy, the~     figures are expected to increase dramatically in the future.~      Alzheimer's disease is the most common form of dementia, as well as 50-60% of patients with~     dementia suffer from this disease. The second most common type of dementia is vascular, ie~     that associated with cerebrovascular disease and is the 15-30% of all dementia cases and is~     most common between the ages of 60-70 years and is more common in men than women. It is~     estimated that 5% to 8% of people over 65 suffer from dementia, while in industrialized~     countries ranges at the following levels :15-25% over 85 and 32% over 90 years.~      Dementia is characterized by a slow onset and progressive course. The syndrome includes~     disorders in general intelligence, learning and memory, problem solving, perception,~     judgment, executive function, language and synergy of movement, but without impairment of~     consciousness.~      Alzheimer's disease is a neurodegenerative disorder with distinct clinical and~     histopathological features, although with variations from person to person.~      In its early stages it is sometimes difficult to diagnose cognitive impairment from normal~     aging of the brain. With the passage of time, the continuous decline in recent memory,~     fluency, ability for spatial orientation ultimately restricts the autonomy regarding basic~     activities of daily life such as managing finances. The anxiety and depression complicate~     diagnosis in early stages, but gradually decline with loss of sensitivity. Intermediate~     stages of the disease require increasingly supervision in daily self-care activities, such as~     personal hygiene and clothing. In the advanced stages are usually essential nursing care in~     institutional context.~      The severity of symptoms of the disease varies and is determined by premorbid factors such as~     education, gender, cultural background. Epidemiological studies have shown as protective~     factors against the onset of dementia, higher education, taking estrogen and~     anti-inflammatory drugs. On the other hand, age, family history of dementia, head injury,~     hypertension and Down syndrome are risk factors for developing the disease. Finally, some~     genetic factors appear to be protective, and other pressures to the disease.~   "
137147|NCT01772082|"~     Persons with COPD are randomized to pedometer versus pedometer plus Internet mediated website~     to promote walking and physical activity. Primary outcome is daily step counts. Intervention~     lasts 3 months.~   "
137148|NCT01772069|"~     Systemic lupus erythematosus (SLE) patients show a high prevalence of fibromyalgia though~     rates vary considerably from one study to another (from 8.2% to 45%). Although fibromyalgia~     can bring out the disability in daily life, the majority of previous reports only ascertained~     no significant association between the presence of fibromyalgia and the severity of SLE.~      It is necessary to make unremitting effort to reduce the mortality and life-threatening~     disease flare-up due to SLE disease itself. Additionally, we think that physicians need to~     pay more attention to improve health-related quality of life (HRQoL) in the patients with~     SLE. HRQoL could be influenced by various factors such as depression, fibromyalgia, disease~     duration, disease activity and etc. To improve the HRQoL in SLE patients, it might be the~     clinically important and constructive theme to investigate that which is the most important~     factor among the fibromyalgia, depression, sleep quality, SLE activity and SLE duration.~      The objective of this study is to evaluate the degree of contribution of fibromyalgia for~     reduced HRQoL and to identify the status of managing fibromyalgia in Korean patients with~     SLE.~   "
137149|NCT01772056|"~     The relapsing nature of atopic dermatitis (AD) presents a challenge for its long-term~     treatment. Efficacy and safety of corticosteroids have been proven in the acute treatment of~     AD, but not its efficacy and security to reduce or prevent relapses.~      Objectives To investigate long-term management (16 weeks) of AD with fluticasone propionate~     (FP) 0,05% cream twice weekly in addition to an emollient (vehicle) after stabilization of an~     acute flare of AD with FP cream.~   "
137150|NCT01772043|"~     We will utilize the Cooperative International Neuromuscular Research Group (CINRG) network to~     collect and store tissue and blood from patients with Duchenne muscular dystrophy (DMD) with~     specific genetic mutations within the dystrophin gene that could be treated by antisense~     oligonucleotide (AO) drugs.~   "
137151|NCT01772030|"~     The purpose of the study is to evaluate the mechanisms of recurrent atrial fibrillation after~     cryoballoon ablation using the Arctic Front Ablation System. For those with pulmonary vein~     reconnection, specific sites of reconnection will be evaluated with left atrial intracardiac~     echo (ICE) guidance. The Achieve mapping catheter will be evaluated head-to-head with our~     current method of ICE-guided recordings from a conventional mapping catheter with high output~     pulmonary venous pacing.~   "
137152|NCT01772017|"~     To evaluate the safety and efficacy of the Tongue Advancement Retainer Device in treating~     subjects with Obstructive Sleep Apnea (OSA) and snoring.~   "
137153|NCT01772004|"~     This is a Phase 1, open-label, dose-escalation trial of avelumab [antibody targeting~     programmed death ligand 1 (anti PD-L1)] with consecutive parallel group expansion in subjects~     with selected tumor indications. New recruitment is open for all active cohorts.~      Active cohorts: Escalation revised dosing regimen cohort.~      Closed cohorts: Non-small cell lung cancer (NSCLC, first line), NSCLC (post-platinum),~     metastatic breast cancer (MBC), colorectal cancer (CRC), urothelial carcinoma (secondary),~     mesothelioma, gastric/GEJ cancer (first line switch maintenance and second line), and ovarian~     cancer (secondary and platinum refractory + liposomal doxorubicin), renal cell carcinoma~     (second line) melanoma and head, neck squamous cell carcinoma (HNSCC), castrate-resistant~     prostate cancer (CRPC), adrenocortical carcinoma (ACC) urothelial carcinoma (efficacy),~     gastric/gastroesophageal junction (GEJ) cancer (third line), renal cell carcinoma (RCC, first~     line) and escalation phase .~   "
137154|NCT01771991|"~     The purpose of this study is to determine if topical superoxide dismutase is an effective~     treatment of radiation related neck fibrosis, and to determine the quality of life impact~     from radiation related fibrosis in the head and neck cancer patients at Sanford Health.~   "
137155|NCT01771978|"~     Less oxidative stress occurs during off-pump than on-pump coronary artery bypass graft (CABG)~     surgery but warm ischaemia-reperfusion injury may occur following transient coronary artery~     clamping. The aim of this study was to compare the preventive effects of diltiazem and~     N-acetylcysteine (NAC), alone or in combination, on biomarkers of myocardial damage and~     oxidative stress during off-pump CABG surgery.~   "
137156|NCT01771965|"~     The goal of this research plan is to test the effectiveness of a brief, cognitive behavioral~     (CB) intervention to promote behavioral health treatment engagement among at-risk Veterans~     who call the Crisis Line but are resistant to behavioral health services.~   "
137234|NCT01770938|"~     Muscle performance is largely influenced by modulations in gene expressions of muscle tissue.~     In this context, light-emitting diode therapy (LEDT) has been used to improve muscle~     performance in experimental models and human researches. Thereby, the investigators examined~     modulations in gene expression of muscle tissue as well as biochemical, biomechanic and~     histologic adaptations influenced by exercise associated to LEDT.~   "
137161|NCT01771900|"~     The purpose of this feasibility study was to obtain pilot data, as the basis for a future,~     larger investigation, testing the impact of an innovative training camp intervention called~     HEART CAMP (Heart failure Exercise And Resistance Training CAMP) to teach HF patients how to~     exercise and self-manage exercise behavior over time. The study assessed the feasibility and~     adequacy of the intervention, the data collection plan, and the reliability and sensitivity~     of the outcome measures. The 6-month intervention was based on a training camp model to teach~     HF patients how to exercise in a fun, group-oriented atmosphere. Subjects interacted and~     exercised in small groups with an exercise physiologist and nurse to guide activities. The~     dosage of the intervention (frequency and amount of direct guidance from the exercise~     physiologist and nurse) decreased over the 6 months in order to increase subject's~     independence and promote long-term adherence to exercise. The intervention incorporated use~     of computerized data files to monitor exercise behavior, compare exercise performance to~     individualized goals and provide feedback as strategies to foster adherence and~     self-management of exercise behavior.~   "
137162|NCT01771887|"~     Diabetes mellitus is a disease of great frequency and is a major public health problem. In~     Lebanon, the incidence of diabetes is estimated at 12%, it is expected to double by the year~     2025. Given the increasing prevalence of diabetes in Lebanon, the evolution of complications~     of this disease and the lack of studies at this level, it is appropriate to conduct a study~     that aims to evaluate the effects an education program for people with type 2 diabetes on~     their sense of self-efficacy and their ability to self-manage their disease to make them the~     most optimal therapeutic adherence possible. The design of this study is experimental type~     before / after randomization by diabetic patients. Education program delivered to the~     experimental group is the Accu-Chek Education Program of Roche. Membership will be assessed~     using a biomarker HbA1c should be <7%, and a questionnaire (Summary of Diabetes Self-Care~     Activities Measure), which measures self-care behaviors. Self-efficacy is measured using the~     Diabetes Management Self-Efficacy Scale. And this before the intervention and 3 months later.~     The sample will be 240 diabetic patients T2. Recruitment will be in outpatient diabetology a~     Hospital located in Beirut. Statistical analyzes used for descriptive variables are measures~     of central tendency, dispersion and frequency distribution. T-test and chi-square will be~     used to compare the socio-demographic characteristics of the 2 groups, experimental and~     control. To test hypotheses and determine the difference in the results of the dependent~     variables of the 2 groups, analysis of variance and covariance are used. The data will be~     processed using SPSS version 14.0.~   "
137163|NCT01771874|"~     The purpose of this study is to determinate the effect of a pre-treatment with bupropion, a~     dopamine and norepinephrine transporter inhibitor, on the pharmacodynamics and~     pharmacokinetics of 3,4-methylenedioxymethamphetamine (MDMA, Ecstasy). The study will~     provide further understanding of the dopaminergic regulation of mood.~   "
137164|NCT01771861|"~     The aim of the study is to establish the predictive properties of our trauma team activation~     protocol, and its individual criteria, and if possible to suggest changes that reduce over-~     and undertriage.~      The study will also give an overview of the frequency and type of emergency procedures at a~     university hospital trauma center, which can contribute to optimal resource use and indicate~     which type of surgical skills are necessary in our trauma emergency procedures.~   "
137165|NCT01771848|"~     The study is designed to establish the best dose to safely infect healthy individuals with~     Plasmodium falciparum sporozoites (PfSPZ) by injection.~      The goal of this study is to achieve infections in human volunteers with infection rates of~     100% and pre-patent periods of less than 12 days.~   "
137166|NCT01771835|"~     Measurement of the circulation in patients with diabetes mellitus and establish a link~     between retinal venous pressure (RVP) and endothelin (ET-1)levels.~   "
137167|NCT01771822|"~     This study will determine the potential of Ibuprofen 5% Topical Gel and its vehicle gel to~     cause irritation after repeated topical application to the healthy skin of human subjects~     under controlled conditions.~   "
137168|NCT01771809|"~     Subjects with Ulcerative Colitis who have completed an induction study with PF-00547659 will~     receive an additional 144 weeks of open-label treatment to evaluate the long-term safety of~     the drug.~   "
137169|NCT01771796|"~     The purpose of this study is to determine the potential benefits resulting from a specific~     training on exercise tolerance and muscle function at the medium and long-time, as well as~     study its effects on plasmatic mediators (sMICA, IGF-I and IGFBP-3) in patients with lung~     cancer following resection surgery.~   "
137170|NCT01771783|"~     The primary objective is the characterization of the RAS peptide profiles after single and~     repeated oral administration of a renin inhibitor, an ACE inhibitor and an angiotensin~     receptor blocker in healthy volunteers.~      Secondary objectives are the correlation of RAS peptide profiles with pharmacokinetic~     profiles of the different RAS inhibitors and with pharmacodynamic parameters such as blood~     pressure and heart rate. Output of the classic RAS system will be assessed using aldosterone~     concentrations. Fluid and sodium intake will be monitored using sodium concentration and~     total volume in 24h urine.~   "
137171|NCT01771770|"~     The hypothesis is that the pressure in the retinal veins increases from chronic lack of~     oxygen and leads to decreased blood flow. On the basis of high altitude mountaineering this~     hypothesis should be verified. At the same time the adaptation capacity of the blood~     circulation should be analyzed, and a relationship to mountain sickness should be found.~   "
137172|NCT01771757|"~     The hypothesis is that the pressure in the retinal veins increases under a short-term lack of~     oxygen and leads to a decreased blood circulation. On the basis of measurements in the~     hypobaric chamber this hypothesis should be verified.~   "
137173|NCT01771744|"~     This study compared revisional malabsorptive laparoscopic very very long limb gastric bypass~     (VVLL RYGB) with primary VVLL RYGB and tested the hypothesis that one staged revisional~     laparoscopic VVLL RYGB is a safe and effective procedure after failed restrictive gastric~     banding.~   "
137197|NCT01771419|"~     Selective cannulation of common bile duct (CBD) by insertion of a guide-wire seems to be~     associated with fewer complications and post-ERCP (Endoscopic retrograde~     cholangiopancreatography) pancreatitis (PEP) rate than the conventional biliary tree access~     with cannulotome (CT-25 Cook Medical) with contrast injection even if results are~     conflicting. the aim of our study is to test a new guide-wire (loop-tip wire), with a loop in~     the tip, for the prevention of PEP and biliary tree access, in PEP high-risk patients.~   "
137174|NCT01771731|"~     Our primary objective is to assess whether inhaling vaporized cannabis ameliorates chronic~     pain in patients with sickle cell disease (SCD). As these patients will all be on chronic~     opioid analgesics, the investigators will also assess the possible synergistic affect between~     inhaled cannabis and opioids. The investigators will also assess the clinical safety of the~     concomitant use of cannabinoids and these opioids in patients with SCD by monitoring the~     short-term side effects associated with combined therapy. Finally, the investigators will~     evaluate the short-term effects of inhaled cannabis on markers of inflammation and disease~     progression in patients with SCD.~      Hypotheses are as follows:~        1. Inhaled cannabis will significantly reduce chronic pain in patients with SCD.~        2. Inhaled cannabis will significantly alter the short-term side effects experienced by~          patients who take opioids for SCD.~        3. Inhaled cannabis will significantly alter markers of inflammation and disease~          progression in patients with SCD compared to placebo.~   "
137175|NCT01771718|"~     The purpose of this pilot study is to employ multiphoton microscopy to non-invasively image~     in-vivo pigmented and non-pigmented human skin lesions for characterization of their~     morphologic and functional features. .~   "
137176|NCT01771705|"~     The purpose of this study is to compare two different ways of monitoring the immune system to~     determine how to manage the doses of anti-rejection medications.~   "
137177|NCT01771692|"~     Fixed braces (appliances) are used to straighten the malalignment of teeth. There has been a~     lot of research into the factors that can affect the speed of alignment of teeth but there~     has been very little research on how different techniques of wire attachment to the brace~     (ligation) can affect this.~      The randomised clinical trial of 100 patients aims to compare the speed of alignment of the~     lower (mandibular) front teeth (incisors) using two different techniques over a period of 12~     weeks. Both techniques use the conventional small elastic rings (modules) that are placed~     over each metal square (bracket) but they will be tied in a different configuration for each~     group. We will also observe any differences in the distances between the corresponding teeth~     either side of the lower jaw for each group and the bracket failure rates.~   "
137178|NCT01771679|"~     The purpose of this study is to determine whether a one-time injection of allogeneic~     mesenchymal bone marrow cells is safe and beneficial in the treatment of photodamage on the~     face.~   "
137179|NCT01771666|"~     The purpose of this study is to determine if Indocyanine Green (IC-GREEN) is comparable to~     isosulfan blue (IS-BLUE) in the identification of arm lymphatics and arm-draining nodes~     during nodal staging procedures in breast cancer.~   "
137180|NCT01771653|"~     The purpose of this observational study is to compare two approved treatment regimen(s)~     containing boceprevir and telaprevir, as part of standard of care for the treatment of~     hepatitis C.~   "
137181|NCT01771640|"~     ALS is a debilitating disease with varied etiology characterized by rapidly progressive~     weakness, muscle atrophy and fasciculations, muscle spasticity, difficulty speaking~     (dysarthria), difficulty swallowing (dysphagia), and difficulty breathing (dyspnea). ALS is~     the most common of the five motor neuron diseases.Riluzole (Rilutek) is the only treatment~     that has been found to improve survival but only to a modest extent. It lengthens survival by~     several months, and may have a greater survival benefit for those with a bulbar onset. It~     also extends the time before a person needs ventilation support.Stem cell transplantation is~     a new hopeful way to improve the patients conditions and reduce the period of disabilities.~   "
137182|NCT01771627|"~     This pilot clinical trial studies varenicline or nicotine patch in promoting smoking~     cessation among current smokers. Varenicline or nicotine patch may help people stop smoking~   "
137183|NCT01771614|"~     Experimental hyperglycemia (5 hours) will be induced via a constant- or fluctuating-rate~     glucose infusion to establish different patterns of glycemia in healthy individuals. The~     effects of these acute models of hyperglycemia on the adaptations to a single aerobic~     exercise bout will be tested. Changes in pancreatic endocrine function, insulin sensitivity,~     endothelial function, and oxidative stress will be measured.~   "
137184|NCT01771601|"~     Regional tissue oxygenation (cStO2) can be monitored by near infrared spectroscopy. The~     commercial device INVOS 5100 (COVIDIEN, Mansfield, MA, USA) and the prototype OxyPrem vs. 1.2~     (Biomedical Optics Research Laboratory, Zurich, Switzerland) will be used simultaneously to~     test for their relative sensitivity for low oxygen levels just after birth on term infants~     born by elective caesarean section. Reproducibility will be examined by replacements of the~     sensors six times the next day when the infant is stable and quiet. The Adult Somasensor~     (INVOS) will be used together with the OxyPrem sensor.~   "
137185|NCT01771588|"~     It it is hypothesized that the growth of preterm infants receiving a new human milk fortifier~     will be equal or superior to the growth of preterm infants receiving a currently marketed~     human milk fortifier with a lower protein content.~   "
137186|NCT01771575|"~     Traumatic brain injury (TBI) is a major worldwide health issue. Figures from the Centers for~     Disease control show that 1.7 million people suffer a TBI annually. Meanwhile the World~     Health Organization recognizes TBI as one of the most significant health issues in developing~     countries. In the military, mild traumatic brain injury (mTBI) is one of the most frequent~     sequela of modern war. Dizziness and balance disorders are the most frequent sequela of mTBI~     and account for a significant degree of mTBI morbidity. At the current time, the best~     treatment modality for dizziness secondary to mTBI is vestibular rehabilitation (VR). While~     VR is effective, the therapy is time consuming, not universally successful, and results in~     incomplete recovery by many patients. Work needs to be done in an attempt to improve therapy~     outcomes. This project will study the use of neuromodulation (through stimulation of the~     tongue) as an adjuvant to improve the effectiveness of VR and reduce the time involved in VR.~     Given past work with variants on this minimal medical impact appliance, using the PoNS™~     device to augment therapy may result in a significant improvement in VR outcomes. Given the~     enormous public health and military burden of mTBI, and given that dizziness is a major~     component often responsible for significant morbidity, this project has significant military~     and civilian impact and can be beneficial to those who suffer mTBI worldwide.~   "
137198|NCT01771406|"~     The aim of this study is to examine how effective CPAP treatment and treatment with nebivolol~     are respectively on reducing blood pressure and on endothelial dysfunction in patients~     suffering from obstructive sleep apnea and hypertension.~   "
137187|NCT01771562|"~     The advent of highly active antiretroviral treatment has resulted in the survival into~     adolescence of an increasing proportion of infants and children with perinatal HIV infection~     in Senegal. However, the transformation of HIV into a chronic disease needing lifelong~     antiretroviral treatment (ART) raises new challenges, among others related to a disturbance~     of glucose metabolism, lipid abnormalities, in addition to the potential effects on~     children's growth and puberty. Little is known on nutritional and metabolic changes in~     HIV-infected children on ART in Africa, while implementation of the latest WHO~     recommendations should eventually lead to an increase in the number of children on ART in~     this region. Moreover, bio-clinical evolution of untreated children is poorly documented in~     the African context. It therefore urgently needed to institute a cohort study to evaluate, in~     the long term, the impact of HIV infection and/or ART on nutritional and metabolic disorders~     and to characterize the risk factors of their occurrence in children and adolescents infected~     as they move through adolescent into adulthood.~   "
137188|NCT01771549|"~     This pilot study involves very frequent monitoring of breast cancer patient blood levels of~     hs-cTnT Troponin and n-t-BNP (Brain Natriuretic Peptide) before and after initiation of~     chemotherapy with either adriamycin or trastuzumab in order to define the kinetics of both~     biomarkers during the first two cycles of chemotherapy. Cardiac troponins and BNP are~     frequently elevated after experimental chemotherapy in animal models. Their behavior in~     humans has been inconsistent, with occasional elevations seen, usually within 30 days of~     therapy. Assays for troponin with sensitivity into the pg/ml range have now been introduced.~     A majority of patients greater than age 50 have elevations above the detection limit,~     compared to only 1-3% with conventional troponin assays, and over 90% of diabetics have~     elevations above the detection limit. Moreover, augmented release of high sensitivity~     troponin is detected after exercise or rapid atrial pacing of durations of 10-15 minutes in~     patients with and without coronary artery disease. This improved sensitivity suggests the~     potential for detection and monitoring of cardiac damage after cancer chemotherapy. We~     hypothesized that this new generation of troponin assay would be associated with kinetic~     behavior suggesting ongoing cardiac damage with anthracycline therapy, and possibly also with~     trastuzumab.~   "
137189|NCT01771536|"~     Despite several large clinical trials clearly establishing that coronary revascularization~     (i.e. percutaneous coronary intervention - PCI) does not prolong survival or prevent~     myocardial infarction (MI) for stable coronary artery disease (CAD), patients with stable~     angina continue to believe that PCI is performed to improve these outcomes. Additionally,~     recent concerns have emerged of overuse of PCI among patients with little or no angina. Thus~     there is a compelling need to share with patients the risks and benefits of PCI prior to~     treatment to reach an informed decision.~      This study is designed to answer the question of whether a decision aid can improve patient~     knowledge, decisional conflict and patient satisfaction with decision-making compared to~     usual care for the treatment of stable angina.~   "
137190|NCT01771523|"~     Background : The use of suction drains in thyroid surgery is common practice in order to~     avoid haematoma or seroma, as well as to identify promptly the onset of haemorrhaging that~     might compromise the patient's airway. The aim of this study to determine the effects of~     routine drainage compared to no drainage in thyroidectomy patients.~      Study Design : Total of 400 patients who undergoing total thyroidectomy or lobectomy for~     thyroidal disorders will be randomly allocated to be drained or not. Postoperative~     ultrasonographic (USG) neck examination will be performed for all patients on postoperative~     24th hour by the same ultrasonologist each time. Postoperative pain, complications and~     hospital stay will be recorded. The statistical analysis will be performed and p<0,05 will be~     accepted as an important statistical value (SPSS 16.0 for Windows).~   "
137191|NCT01771497|"~     The hypothesis of this study is that using Koning Breast CT during the neoadjuvant treatment~     of breast cancer will allow for accurate tumor localization and tumor volume measurement,~     leading to improved surgical and radiation therapy outcomes.~   "
137192|NCT01771484|"~     The investigators will test to determine if an external Automated Abdominal Binder~     (non-commercial product) during high sodium diet improves orthostatic tolerance, compared to~     wearing the binder during a low sodium diet session.~   "
137193|NCT01771471|"~     This is a clinical study to collect safety and preliminary efficiency information on the use~     of NuQu chondrocytes (cartilage cells) delivered to the center of a lumbar spinal disc to~     treat low back pain.~   "
137194|NCT01771458|"~     SHIVA is a proof of concept randomized phase II trial which compares two treatment strategies~     for patients with refractory cancer.~      From a tumor biopsy, a molecular profile of the disease is established (mutations,~     amplifications, hormone receptor status). If a molecular abnormality is identified for which~     an approved targeted agent is available, patients are randomized randomized between two arms:~        -  Targeted therapy based on the molecular profile~        -  Conventional therapy based on investigator's choice.~      A cross-over is proposed at disease progression.~   "
137195|NCT01771445|"~     Aim: Evaluate the regulation of muscle derived Interleukin-6 (IL-6)during exercise and in~     particular whether it is regulated by the Interleukin-1 (IL-1) system.~      Rationale: It has been shown that IL-1 antagonism improves glycemia and insulin secretion in~     patients with type 2 Diabetes. However, IL-1 antagonism also decreases IL-6 levels. The~     effect if IL-6 on the glucose metabolism has been unclear in the past and subject to intense~     debate, with recent evidence indicating a beneficial role in regulating glucose metabolism.~     However little is known about regulation of muscle-induced IL-6 produced during exercise. It~     is therefore our aim to investigate whether exercise induced increases in IL-6 are dependent~     on the IL-1 system. If IL-1 antagonism does decrease IL-6 and along with it, the beneficial~     potential of IL-6, this may require additional medication like IL-6 substitution or~     dipeptidyl peptidase-IV (DPP-IV)antagonists.~      In addition, the investigators will assess the effect of IL-1 antagonism on insulin and~     Glucagon like peptide-1 (GLP-1) secretion as well as muscle soreness,fatigue and vascular~     function in response to an acute exercise bout.~   "
137196|NCT01771432|"~     Objective: To determine whether antibiotic treatment of asymptomatic bacteriuria in kidney~     transplant recipients could be useful to prevent pyelonephritis in these patients.~   "
137235|NCT01770925|"~     non-invasive ventilation in preterms complaining from RDS a randomized, controlled trial to~     compare between capap and n-bipap~   "
137199|NCT01771393|"~     ConeBeam scanner (CBCT) is a widely technique used for dental and maxillofacial imaging.~     Patients can be set up in a sitting or a laying position in the, Newtom 5G CBCT allowing for~     an analysis of the limbs distal joints. Our hypothesis is that the cone-beam scanner could~     detect and characterize chondral lesions the cartilage similarly to a multidetector CT~     (MDCT). 100 patients over 18 years requiring arthroscanner of the wrist, ankle, elbow or knee~     will be enrolled The primary endpoint based on the ability of cone-beam scanner to detect~     cartilage lesions. Secondary endpoints will concern the depiction of the joint lesions,~     quality of the images, tolerability of the exams and inter- intra-operator reproducibility.~     After arthrography, patients will have a MDCT considered as the reference exam, and a CBCT on~     a randomized order. Exams will be anonymized and read twice by two trained radiologists with~     3-6 week intervals. The inter-observer agreement for the diagnosis of cartilage lesion type~     between the two techniques will be evaluated by a kappa coefficient. The evaluation of~     diagnostic performance will be achieved by studying the sensitivity, specificity, negative~     predictive value and positive predictive value, and its likelihood ratio. Kappa test will be~     performed to evaluate the consistency of the depiction of the lesions. A Student t test will~     be performed for paired data if distributions are normal, a Wilcoxon test if not. To assess~     patient's tolerance, the percentages of (painful, not painful) will be calculated for each~     technique and will be compared using the Chi2 test (or Fisher's exact test if the chi can not~     apply).~   "
137200|NCT01771380|"~     In the circulation 25-hydroxyvitaminD (25(OH)D) is bound to the vitamin D binding protein~     (DBP) and albumin. According to the free hormone hypothesis, it is, however, the free~     fraction that is biologically active. Polymorphisms in DBP are related to the serum level of~     25(OH)D. As these polymorphisms may also affect the binding affinities for 25(OH)D, the total~     serum 25(OH)D may not necessary reflect the free fraction. To test this hypothesis, we will~     calculate the free fraction of 25(OH)D by correction for DBP and albumin content, and also~     measure free 25(OH)D from equilibrium dialysis and ultra filtration. Furthermore, we will~     relate total serum 25(OH)D as well as the free and biologically active (free- albumin-bound)~     25(OH)D to the well established vitamin D effect marker serum parathyroid hormone as well as~     to the RNA expression in peripheral blood to evaluate the biological importance of the free~     versus the total fraction of 25(OH)D. We will invite 300 subjects from an ongoing vitamin D~     supplementation study to participate in the study which will be one visit only and include~     collection of blood samples.~   "
137201|NCT01771367|"~     It is thought that vaccines trigger innate inflammatory responses to induce antigen-specific~     adaptive immunity (the desired effect), but excessive inflammation may lead to serious~     inflammatory complications or unwanted side effects. Currently there is a lack of reliable~     biomarkers (a measurable biological response that predicts something) able to predict severe~     inflammation and this has resulted in the development of several vaccines being terminated~     and the withdrawal of some licensed vaccines which were associated with inflammatory~     complications.~      This study is part of the BIOVACSAFE project which is a 5-year 30 million Euro project funded~     by the Innovative Medicines Initiative. The project involves a series of clinical studies~     using licensed vaccines as benchmarks to generate clinical data on inflammation and identify~     biomarkers that can be used to predict acceptable reactogenicity. The target is to identify~     biomarkers that can predict the occurrence of beneficial and detrimental effects in response~     to a vaccine. Such biomarkers could be used in future vaccine development programs to~     optimise selection of vaccine candidates with a profile that will be unlikely to generate~     worrisome safety signals once they are in generalised use.~      This study is one in a series of training studies which will each use different licensed~     vaccines that are prototypical representatives of a class of vaccine used in a particular~     population. Forty-eight subjects will be randomised into three groups to receive: a) Fluad~     (n=20), b) Agrippal (n=20), c) saline placebo (n=8). Following a screening visit,~     participants will undergo a seven-day residential visit which will include immunisation and~     intensive monitoring of physiological (e.g. heart rate, oral temperature, blood pressure)~     metabolic and immune (innate and adaptive) parameters. This visit will be followed up by four~     outpatient visits with further monitoring and blood samples.~   "
137202|NCT01771354|"~     It is thought that vaccines trigger innate inflammatory responses to induce antigenspecific~     adaptive immunity (the desired effect), but excessive inflammation may lead to serious~     inflammatory complications or unwanted side effects. Currently there is a lack of reliable~     biomarkers (a measurable biological response that predicts something) able to predict severe~     inflammation and this has resulted in the development of several vaccines being terminated~     and the withdrawal of some licensed vaccines which were associated with inflammatory~     complications.~      This study is part of the BIOVACSAFE project which is a 5year €30M project funded by the~     Innovative Medicine Initiative. The project involves a series of clinical studies using~     licensed vaccines as benchmarks to generate clinical data on inflammation and identify~     biomarkers that can be used to predict acceptable reactogenicity. The target is to identify~     biomarkers that can predict the occurrence of beneficial and detrimental effects in response~     to a vaccine. Such biomarkers could be used in future vaccine development programs to~     optimize selection of vaccine candidates with a profile that will be unlikely to generate~     worrisome safety signals once they are in generalized use.~      This study is one in a series of training studies which will each use different licensed~     vaccines that are prototypical representatives of a class of vaccine used in a particular~     target population. Twenty four subjects will be randomised into two groups to receive: A)~     Engerix B vaccine (n = 20), B) Saline placebo (n = 4). Following a screening visit,~     participants will undergo two immunisations at month 0 and month 6. Each immunisation will~     occur during a seven day residential visit which will include immunization and intensive~     monitoring of physiological (e.g. heart rate, oral temperature, blood pressure) metabolic and~     immune (innate and adaptive) parameters. Both residential visits will be followed up by four~     outpatient visits with further monitoring and blood samples.~   "
137203|NCT01771341|"~     Neurally adjusted ventilatory support improved synchronization in the medical patient.~     However no data are available in the postoperative patient.~      This way the investigators designed a prospective randomized cross over trial to evaluate~     this issue in the abdominal post-operative patient.~   "
137204|NCT01771328|"~     The conventional glucocorticoid replacement therapy in congenital adrenal hyperplasia (CAH)~     renders the cortisol levels unphysiological, which may cause symptoms and long-term~     complications. Glucocorticoid replacement is technically feasible by continuous subcutaneous~     hydrocortisone infusion (CSHI), and can mimic the normal diurnal cortisol rhythm. This method~     was recently applied to treat a patient through a critical phase of puberty. This is a~     clinical trial aiming to evaluate CSHI treatment in patients with CAH. The main objective is~     to determine the effects of CSHI on metabolic parameters (androstenedione and~     17-hydroxyprogesterone profiles, and testosterone,adrenocorticotropic hormone(ACTH),~     cortisol, and bone markers), and to determine the required glucocorticoid doses. Secondary~     objectives are to determine effects on clinical status, body weight, blood pressure and other~     metabolic parameters, as well as on subjective health status (AddiQoL, SF36).~   "
137205|NCT01771315|"~     The aim of this study is to determine the effect of nurse led follow-up following total knee~     arthroplasty in regard to physical function, health related quality of life and~     self-efficacy.~   "
137248|NCT01770756|"~     The purpose of this study is to compare the effectiveness of two forms of self-care training~     on the overall health of adults with hypertension.~   "
137209|NCT01771263|"~     In closed-loop controlled anesthesia, feedback from a measure of the clinical effect is used~     to continuously adjust drug infusion rates. Anesthetic drugs are delivered at a variable rate~     that is personalized to the individual patient. The aim is to provide greater hemodynamic and~     respiratory stability, more stable depth of anesthesia, the ability to predict recovery and~     to administer a lower total dose of drug. Previous work in closed-loop control of intravenous~     anesthesia has focused on the titration of propofol in response to a depth of hypnosis (DOH)~     measure derived from the electroencephalogram (EEG).~      The purpose of this pilot study is to evaluate iControl-RP, a system, which performs~     controlled delivery of both remifentanil and propofol infusions. iControl-RP allows either~     drug to be operated in any of 3 modes: closed-loop control based on feedback from an EEG~     measure supplied by NeuroSENSE (1); target-controlled infusion (TCI), based on~     previously-described pharmacokinetic (PK) and pharmacodynamic (PD) models; and conventional~     manual infusion, which require a weight-based dose setting.~      A pilot two-phase study will be undertaken in a group of adult patients under the direct and~     immediate supervision of an experienced anesthesiologist. In Phase 1 (involving 50 study~     subjects), propofol will be administered in closed-loop mode and a remifentanil infusion will~     be administered based on a TCI. The data collected in this phase will be used to tune the~     controller parameters, which are initially based on previously published PKPD data. The~     controller performance will then be evaluated in phase 2 (involving 100 study subjects), in~     which both propofol and remifentanil will be administered in closed loop mode. In both~     phases, cases will be selected from those receiving propofol and remifentanil as anesthetic~     agents for routine surgical procedures.~      The investigators aim to demonstrate that closed-loop control of anesthesia and analgesia~     based on EEG feedback is clinically feasible. This pilot study will help us take a~     significant step towards a controlled trial in which the clinical benefit of this method of~     closed-loop control of anesthesia can be assessed.~   "
137210|NCT01771250|"~     This study has two parts. Each participant will receive a daily injection of LY2605541 during~     one treatment period and a daily injection of insulin glargine during the other treatment~     period. Each treatment period is 3 to 4 weeks and is followed by procedures to look at how~     the body uses or stores fats while taking each study drug.~   "
137211|NCT01771237|"~     This exploratory study aims to design and test an HIV prevention intervention for young men~     who have sex with men (MSM) between the ages of 16-20 as this group comprises the US~     adolescent population most at-risk for HIV infection through sexual contact. To help develop~     the content and format of our intervention we will first conduct in-depth interviews with~     twenty-one 18 to 24 year-old young MSM who acquired HIV through male-to-male sexual contact~     between ages 16-20 (i.e., the target age of our intended intervention). We will then design a~     group-based primary intervention for young MSM between ages 16-20, relying on the information~     we gathered from these interviews, as well as consultation from an advisory board of young~     MSM and HIV prevention experts. Last, we will use an experimental design to compare our~     intervention to a control condition. We hypothesize that, relative to a control condition of~     sexual health education and risk reduction, participants in our intervention will demonstrate~     lower rates of HIV risk behavior, find participation more feasible, and endorse greater~     acceptability of our intervention.~   "
137212|NCT01771224|"~     Introduction: Inflammatory bowel disease (IBD) refers to two chronic diseases that cause~     intestinal inflammation, ulcerative colitis (UC) and Crohn's disease (CD). The conventional~     treatment is not effective; therefore, alternative therapies may be effective specially in UC~     patients. Fatty acid (FA) may have a beneficial effect on some UC patients. The increasing~     incidence and prevalence of UC and ineffective treatments in some patients, allows search~     coadjuvant therapies. Objective: Quantification of differences between patients with and~     without FA. Methods: In two groups of patients with UC is administered FA and placebo. We~     will measure the changes clinical, endoscopic and histological in both groups, before and~     after treatment.~   "
137213|NCT01771211|"~     The purpose of this study is to determine if non-invasive electrical brain stimulation can~     improve word-retrieval in Mild Cognitive Impairment (MCI).~   "
137214|NCT01771198|"~     The purpose of this study is to investigate the clinical efficacy of oral treatment with a~     statin, SIMVASTATIN 40mg, in a target population of patients with severe chronic~     rhinosinusitis resistant to surgery followed by conventional medical and surgical treatment.~   "
137215|NCT01771185|"~     Gastric bypass surgery resolves type 2 diabetes mellitus (T2DM) without the need for diabetes~     therapy in ~80% of patients. Moreover, improvement in insulin sensitivity and glucose~     homeostasis occurs within days after surgery before significant weight loss is achieved. This~     observation has led to the notion that bypassing the upper gastrointestinal (GI) tract has~     specific therapeutic effects on insulin action and glucose metabolism. In fact, both surgical~     and endoscopic procedures that bypass the upper GI tract are currently being studied in human~     subjects. Recently, a new surgical technique, duodenal-jejunal bypass surgery (DJBS), has~     been developed specifically to treat T2DM. Data from preliminary studies have shown that DJBS~     results in glycemic control in 87% of overweight and obese patients with T2DM.These subjects~     will undergo metabolic studies at the University Hospital in Sao Paulo before and after their~     surgical procedure. Washington University investigators will: 1) provide technical support~     and guidance to the physicians performing the studies in Brazil, 2) process and analyze blood~     samples obtained from the study at the Washington University Center for Human Nutrition, and~     3) be involved in analyzing the data and writing the final manuscripts. The effects of DJBS~     on the following clinical and metabolic parameters will be evaluated~   "
137216|NCT01771172|"~     To assess the defibrillation efficacy of a subcutaneous defibrillation system.~   "
137217|NCT01771159|"~     Spinal Cord Injured [SCI] patients typically cannot pee. Injury to the spinal cord disrupts~     the in-coming and out-going brain signals that coordinate bladder sensation and the emptying~     of bladder. SCI typically causes chronic retention of urine with uncontrolled leakage of~     urine. Some form of tube (catheter) is needed to drain the urine except with the mildest~     forms of SCI. Two types of tubes to drain the urine have been used for many years. These~     types are the urethral (inserted into the bladder through the opening usually used to empty~     the bladder) and abdominal, called suprapubic cystostomy tubes (put into the bladder through~     the abdomen).~      Bacteria (germs) normally live on our skin. Bacteria have sticky surfaces and so they stick~     to catheter surfaces. Bacteria reproduce very rapidly from a few dozen to over a million in~     24 hours. In a warm liquid environment, like urine, bacteria can reach a density of 10~     million per cubic centimeter in 48 hours which causes infection. Oral drugs and~     antibiotic-coated catheters delay this process by a week or two, but within a month 100% of~     patients have bacteria in their urine. Existing drugs cannot eliminate these microbial~     sanctuaries.~      The TBC is a 'closed access' abdominal drainage tube that has a 'cuff' or 'anchor'. It is~     permanently placed in the abdominal muscle to bond with the body's tissue. Another catheter~     is temporarily connected to the TBC that is easily replaceable in the clinic without~     anesthesia or special instruments. It locks to form a water-tight system. Many parts of the~     TBC are coated with an antibacterial substance that will delay the growth of bacteria. The~     TBC has been used with success in multiple animal studies.~      This is a Phase I human clinical trial in which the TBC will be used 10 spinal cord injured~     patients, each of whom will be followed for 12 months or longer. Abdominal catheter exit~     sites will be photographed monthly and tested periodically to document growth of any~     bacteria. Every three months, patients will complete satisfaction questionnaires and their~     urine will be tested for bacteria. Urine will also be tested as clinically indicated.~   "
137218|NCT01771146|"~     A prospective evaluation of neoadjuvant FOLFIRINOX regimen in patients with non-metastatic~     pancreas cancer (Baylor University Medical Center and Texas Oncology Experience)~   "
137219|NCT01771133|"~     The investigators propose to conduct a randomized controlled trial in 200 overweight/obese~     pregnant women and their offspring. The prenatal intervention will emphasize improving diet~     and physical activity. The lifestyle intervention will be delivered within an empowerment~     theoretical framework through a combination of group sessions, individual counseling, and by~     monitoring compliance to diet and physical activity to further tailor the intervention. The~     post-partum intervention sessions will include mothers and their offspring and will focus on~     breastfeeding, improving physical activity and quality of the diet and feeding practices~     through the first post-partum year. As part of routine prenatal care, participants in both~     the control and intervention arms will be given health-related advice. Since the majority of~     participants are expected to be eligible for the Women, Infants and Children (WIC) program,~     both groups will also receive assistance through WIC as per their routine policies. Our~     primary outcome is Gestational Weight Gain (GWG). The major secondary outcome of interest is~     infant BMI z-score at 12 months of age, and the investigators will also be evaluating several~     metabolic outcomes in mothers and infants.~   "
137220|NCT01771120|"~     An observational cross-sectional study will include 750 individuals of all ages, divided in 4~     groups: 1) Patients with a self-reported diagnosis of asthma alone (n=150), 2) Patients with~     a self-reported diagnosis of rhinitis alone (n=150), 3) Patients with a self-reported~     diagnosis of asthma and rhinitis (n=150) and 4) Patients with no history of respiratory~     symptoms or diseases (n=300)~   "
137221|NCT01771107|"~     This pilot phase I/II trial studies the side effects and the best dose of brentuximab vedotin~     when given together with combination chemotherapy and to see how well they work in treating~     patients with stage II-IV human immunodeficiency virus (HIV)-associated Hodgkin lymphoma.~     Monoclonal antibodies, such as brentuximab vedotin, may block cancer growth in different ways~     by targeting certain cells. Drugs used in chemotherapy, such as doxorubicin hydrochloride,~     vinblastine sulfate, and dacarbazine, work in different ways to stop the growth of cancer~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Giving brentuximab vedotin together with combination chemotherapy may kill more~     cancer cells.~   "
137222|NCT01771094|"~     The purpose of this study is to determine if water and diet soft drinks with different levels~     of sweeteners have the same effect on thirst.~   "
137223|NCT01771081|"~     POLARIS : A non-interventional study in patients with diabetic macular edema (DME) with~     central involvement to assess the effectiveness of existing anti-vascular endothelial growth~     factor (anti-VEGF) treatment regimens.~   "
137224|NCT01771068|"~     The present study aims to examine the effectiveness of a parenting intervention, the Triple P~     Positive Parenting Program Level 3 discussion groups dealing with disobedience. Triple P is~     a system of interventions to support families and was developed at the University of~     Queensland in Australia in the 1980's. As few studies have tested the effectiveness of~     parenting programs in developing countries, the present study took place in a developing~     country, Panama.~      In a recent study carried out in Australia, this same intervention was found effective in~     reducing child behaviour problems and the use of dysfunctional parenting (Morawska, Haslam,~     Milne & Sanders, 2011).~   "
137225|NCT01771055|"~     The purpose of this study is to find if direct peritoneal resuscitation helps blood flow~     through important organs in a person's body after they have had a traumatic injury with~     massive blood loss. Sometimes after severe injuries requiring operation, surgeons cannot~     close the muscles and skin of a patient's belly, because of swelling. This study will also~     try to find if direct peritoneal resuscitation decreases tissue swelling and allows for~     quicker closure of of a patient's belly.~   "
137226|NCT01771042|"~     Elevated subconscious nervous system activity is a characteristic of the obese state and~     contributes importantly to the risk of heart disease and diabetes. This project will compare~     sympathetic nervous system activity and function in a group of obese persons with differing~     levels of sugar tolerance (normal, impaired and type 2 diabetic). Inter-relationships with~     insulin action, blood pressure, heart and kidney function will be determined before and after~     a 4-month weight loss and 3-month weight loss maintenance program.~      It is hypothesized that the transition from normal sugar tolerance to impaired sugar~     tolerance to type 2 diabetes will be accompanied by escalating sympathetic nervous system~     dysfunction. Furthermore, that weight loss will favorably improve sympathetic function, with~     greatest benefits occurring in those subjects who are insulin resistant with high blood~     insulin concentration.~   "
137227|NCT01771029|"~     Validation of the technical performance of the BRAHMS PTC direct point-of-care assay under~     routine conditions with native patient samples. The clinical validation is planned as a~     method comparison to a reference method (BRAHMS PCT sensitive KRYPTOR, Elecsys BRAHMS PCT).~     The study hypothesis is to show a highest correlation between the new product and the~     reference methods.~   "
137228|NCT01771016|"~     Retrospective analysis of requests of emergency hormonal contraception using pharmacy~     protocols registered in 2003 and 2006.~   "
137229|NCT01771003|"~     Partial Nephrectomy has become the standard treatment in patients with tumours <7cm (T1).~     Even though this is a nephron sparing surgery, there is still potential for acute kidney~     injury, due to ischemia during the surgery. Remote Ischemia Preconditioning may prevent acute~     kidney injury and in turn chronic kidney disease. Remote Ischemia pre-conditioning involves~     applying a blood pressure cuff and inflating and deflating several times immediately prior to~     surgery.~   "
137230|NCT01770990|"~     This study aims to compare the effectiveness of two telephone-based psychotherapy (Tel-PT)~     interventions for patients with mild to moderate depression. Both interventions consist of~     one personal session and weekly to bi-weekly 8-10 telephone sessions with a licensed~     cognitive-behavioral psychotherapist accompanied by the study of educational materials and~     the completion of regular monitoring questionnaires (total treatment duration: approximately~     3 months). Patients are randomized into one of two conditions: Patients in the condition~     Tel-PT including mail additionally receive a motivating letter from their psychotherapist~     after each telephone session, while patients in the condition Tel-PT without mail receive~     no further interventions. Patients refusing to be randomized are to be assigned to the~     condition Tel-PT without mail. This study takes place within a larger study evaluating a~     stepped care model for depression (01KQ1002B-TP7).~   "
137249|NCT01770743|"~     The purpose of this study is to assess the safety and immunogenicity of an anthrax vaccine.~     The vaccine schedule and dose will also be assessed.~   "
137236|NCT01770912|"~     The hypothesis to be tested is temporomandibular joint (TMJ) rinsing followed by steroid~     injection is more efficacious than a placebo injection based on standard pain and physical~     measures that are recorded before and after treatment.~      All procedures will be the same as if following normal TMJ arthrocentesis (rinsing) clinical~     care except that the patient will be randomly assigned to one of two groups: (1) TMJ rinsing~     followed by the injection of 1 cc (about ¼ of a teaspoon) of the same rinsing solution (this~     is the placebo) into the jaw joint; or (2) TMJ rinsing followed by the injection of 1 cc~     (about ¼ teaspoon) of a steroid (5 mg of triamcinolone hexacetonide) into the jaw joint. A~     pregnancy test (urine test) will be conducted on all women of child-bearing age to verify~     that the patient is not pregnant before the rinsing procedure. The patient will fill out a~     short questionnaire and have a short exam of the TMJ and jaw muscles at each appointment.~   "
137237|NCT01770899|"~     The purpose of this study is to evaluate the effectiveness of oral montelukast (Singulair)~     given with other standard asthma medications and treatments in the treatment of children with~     status asthmaticus. Status asthmaticus is an acute asthma attack that does not respond to~     standard intermittent treatments but requires a continuous medication to aid in breathing.~     While new medications have been used to better manage chronic asthma, acute asthma~     exacerbations continue to be a significant cause of hospitalization and even death in~     children. Oral montelukast is a very safe medication that is used to manage chronic asthma in~     children, but it has not been studied for use in status asthmaticus. If oral montelukast,~     given with other standard therapies, can reduce the treatment length associated with severe,~     acute asthma exacerbations in children, it could potentially improve both the morbidity and~     burden of pediatric asthma.~   "
137238|NCT01770886|"~     A randomised, double-blind, placebo-controlled, phase I study in healthy subjects. Safety,~     pharmacokinetic and pharmacodynamic data will be collected.~   "
137239|NCT01770873|"~     The purpose of this study is to test whether a violence prevention curriculum delivered by~     Big Brothers and Big Sisters staff and mentors can reduce violence involvement for~     assault-injured youth.~   "
137240|NCT01770860|"~     This two-week study will compare the healing of minor wounds when no bandage is applied~     against four different types of bandages.~      The study investigators will make five small wounds similar to scrapes (about a half-inch~     square) on the back of subjects who qualify to participate in the trial and have given~     informed consent. Four of the wounds will be covered by different bandages and one will be~     left uncovered. Participants will visit the clinic every day for 2 weeks or until all the~     wounds are healed (whichever comes first). At the clinic, the bandages will be removed, the~     doctor will score the wounds, a picture will be taken of the wounds and new bandages will be~     applied.~      It is expected that some pain and itching will be experienced, because they are part of the~     normal wound healing process. Subjects will be asked about adverse events at each visit and~     will have the opportunity to discuss issues or concerns with the investigator or the doctor~     during the course of the trial. It is expected that the wounds will be completely healed~     within 14 days, but if not, the participant will need to return to the clinic for follow-up~     treatment until the wounds are completely healed.~      We will see if the different bandages help with the healing of the wounds during the study.~   "
137241|NCT01770847|"~     Diurnal variations in the cardiovascular system apparent in healthy individuals, are~     different in chronic kidney disease patients. Therefore, diurnal variations in arterial~     stiffness may also differ in chronic kidney disease patients. This study aims to identify and~     evaluate diurnal variations in arterial stiffness in chronic kidney disease patients and~     compare them to those in age matched healthy controls.~   "
137242|NCT01770834|"~     This prospective, observational study will evaluate the efficacy, safety and tolerability of~     RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid~     arthritis who have had an inadequate response or are intolerant to one or more conventional~     disease-modifying anti-rheumatic drugs. Data will be collected from patients initiated on~     RoActemra/Actemra treatment according to the local label at baseline, Weeks 4, 12 and 24, and~     at 3 and 6 months after the last dose of study drug.~   "
137243|NCT01770821|"~     Patients with critical illness loose bodymass, mainly muscle. The purpose of the present~     study is to evaluate wheather tailored physical training and/or a sip drink (proteinrich)~     have effect on the six minutes walking test (6MWT), muscle strength, body weight, body~     composition and quality of life after intensive care. This is a single center randomised~     controled study comprising patients ≥45 years of age staying 5 days or more in the intensive~     care unit (ICU). The design is factorial. Inclusion takes place when the patient is leaving~     the ICU.~   "
137244|NCT01770808|"~     Digestive discomfort includes gastrointestinal symptoms such as abdominal pain, altered bowel~     habit, flatulence and bloating and can sometimes result from slower intestinal transit and~     other digestive irregularities.~      The objective of this study is to investigate the effect of consuming Aquamin (as AquaCal and~     AquaPT) on digestive discomfort and symptoms amongst adults without diagnosed~     gastrointestinal disorders.~   "
137245|NCT01770795|"~     To evaluate the efficacy and safety Genexol-PM(CrEL-free polymeric micelle formulated~     paclitaxel)and gemcitabine in untreated metastatic NSCLC patients~   "
137246|NCT01770782|"~     The objective of this study was to evaluate the effect of the orthodontic retainer on~     transverse maxillary dental and skeletal stability after SARME.~   "
137247|NCT01770769|"~     Clinical research during the last ten years has revealed that elderly patients with a~     displaced femoral neck fracture should be treated with arthroplasty instead of closed~     reduction of the fracture followed by internal fixation with pins or screws. Few clinical~     trials have addressed undisplaced or minimally displaced fractures of the femoral neck. These~     fractures have been associated with a good prognosis and likewise a good functional outcome.~     However, recent articles present far less favorable results, with high re-operation rates~     (10-15%), reduced function, and pain on walking after internal fixation. Indirect comparing~     studies, suggest that hemiarthroplasty may yield better functional outcomes and lower~     re-operation rates. Approximately 20% of all femoral neck fractures in patients aged 70 years~     or older are minimally displaced or undisplaced. Hence the investigators call for a~     randomised controlled trial comparing pain, function, walking ability, quality of life,~     re-operation rates and complications after internal fixation versus hemiarthroplasty in~     patients aged 70 years and older.~   "
137250|NCT01770730|"~     The novel urine LAM point-of-care strip test offers potential clinical utility to improve TB~     diagnosis in HIV co-infected patients. Urine LAM strip test performance improves with~     increasing illness severity and more advanced immunosuppression, thus offering the greatest~     potential utility in hospitalised HIV-infected patients with advanced immunosuppression (CD4~     cell count less than 200). However, in the context of high rates of empiric treatment and the~     availability of other novel TB diagnostics, the clinical impact of the urine LAM strip test~     is unknown. This study will investigate the impact of the urine LAM strip test. The study~     hypothesis is that the urine LAM strip test, when combined with standard TB diagnostics~     (smear microscopy and culture) will significantly improve TB treatment-related outcomes~     (TB-related mortality, morbidity and length of hospital stay) in HIV-infected hospitalized~     patients when compared to standard TB diagnostics alone.~   "
137251|NCT01770717|"~     Pressure ulcers are a significant problem in institutionalized, elderly, and critically ill~     patients. Pressure ulcers result in significant pain, changing quality of life, and often~     leading to significant morbidity and prolonged hospital stays, and ultimately increased the~     healthcare cost.~      According to the International Pressure Ulcer Prevalence Survey, the prevalence of hospital~     acquired pressure ulcers in the United States was 13.5% in 2008 and 12.8% in 2009. This~     survey also indicated that the highest rate of pressure ulcers is in the long term acute care~     population (22%).~   "
137252|NCT01770704|"~     The objective of the ambispective cohort study is to describe clinical management and~     clinical outcomes related to bipolar disorder in China, and establish the factors associated~     with different management patterns and clinical outcomes, provide psychiatrists with reliable~     and up-to-date information on the disease.~   "
137253|NCT01770691|"~     Stress urinary incontinence (SUI) is most prevalent among women. SUI is characterized by loss~     of urine from increased abdominal pressures caused by coughing, laughing, sneezing, running,~     lifting or walking. SUI cause women to avoid routine physical activities, thus detracting~     significantly from their quality of life.~      The purpose of this study is to evaluate the performance of new designs of the TIPI device, a~     conservative, disposable, treatment for temporary management of SUI.~   "
137254|NCT01770678|"~     Cerebral palsy remains a major cause of lifelong disability affecting approximately 2 per~     1,000 children. Of those about 30% have hemiplegic cerebral palsy (HPC),a unilateral~     impairment, which can often lead to major difficulties with manual dexterity and upper~     limb,functional ability and independence. Therapists employ a number of strategies in upper~     limb rehabilitation however they are poorly understood and their efficacy has been~     questioned. Constraint induced movement therapy (CIMT)has been found to be an effective~     intervention with HCP however its use in the preschool child within a national health service~     (NHS) setting has not been evaluated. The investigators aim is to compare CIMT using~     prolonged restraint with CIMT using brief manual restraint which may be standard practice and~     acts as the control. This age group has been targeted as there may be greatest neural~     plasticity (change)and minimal disruption to compulsory education. The investigators intend~     to recruit 60 patients from treatment databases of participating trusts. Patients will be~     randomised following baseline assessments which will include 2 upper limb assessments(The~     Assisting Hand Assessment and the Quality of Upper Extremity Skills Test) and a quality of~     life questionnaire (PedsQL Generic Core Scales and the Cerebral Palsy Module) for parents.~     The intervention period will be for 6 weeks offered intermittently (2week blocks) over 10~     weeks. Parents /guardians and possibly preschool workers will be expected to carry out a~     therapy guided programme. The amount of intervention and compliance will be recorded by~     parents/guardians and therapists. Assessments will be repeated at 10 weeks and 24 weeks from~     the beginning of the trial. The results of the trial will contribute to the evidence on the~     effectiveness of CIMT in the preschool child with HCP, and will also provide evidence on the~     implementation of CIMT delivery within the current NHS therapy services.~   "
137255|NCT01770665|"~     Testing Mayo Clinic cancer patients with the results being correlated with prior patient~     therapy, performance status, and extent of disease.~   "
137256|NCT01770652|"~     Multi-center, non-randomized, open-label, single-dose, parallel group study to determine the~     effect of impaired renal function on the PK of deferiprone and its 3-O-glucuronide metabolite~     following a single oral dose of 33mg/kg Ferriprox®.~   "
137257|NCT01770639|"~     The aim of this study is to investigate the clinical outcomes of surgical correction of foot~     deformity with the MFB in a larger group of patients with neurological impairment of the~     foot.~   "
137258|NCT01770626|"~     The study is designed to evaluate how the composition of a participant's body, diagnosed with~     a brain tumor (glioblastoma multiforme) as determined by bioelectrical impedance analysis can~     predict the progression and outcomes of disease.~   "
137259|NCT01770613|"~     The purpose of this study is to assess the safety and tolerability of human allogeneic~     mesenchymal bone marrow cells (aMBMC) administered intravenously to subjects with ST Segment~     Elevation Myocardial Infarction (STEMI).~   "
137260|NCT01770600|"~     This study is dedicated to achieving a better understanding of how the brain processes~     information. Specifically, the investigators are studying cognitive function, thought~     process, and impulsivity in people with and without suicidal thoughts. You are being asked to~     participate in a research study to learn how the use of a medication, risperidone, improves~     your symptoms of depression. Specifically the investigators are studying the effectiveness of~     reducing the thought of suicide and other symptoms of severe depression. Risperidone is~     approved by FDA for the treatment of schizophrenia and bipolar mania, and clinical practice~     suggests that it might benefit patients with major depressive disorder. During clinical~     trials with 2607 patients, risperidone was proved to be safe. This is a pilot study to test a~     new indication of risperidone for treatment of severe depression. The study medication will~     be given in addition to usual psychiatric care.~   "
137261|NCT01770587|"~     An open-label trial to investigate the use of a behavioral insomnia treatment for suicidal~     ideation.~   "
137262|NCT01770574|"~     The purpose of this study is to determine whether structural calcium ceramic bone graft~     substitute (ReproBone™) is non-inferior compared to autologous tricortical iliac crest bone~     graft in lateral calcaneal lengthening osteotomies in pediatric patients and reduces~     postoperative pain.~      To groups of patients (age 5-16) will be compared. One group randomized to autologous bone~     graft and the other group randomized to calcium ceramic.~      The evaluation will be based on radiostereometric analysis, pedobarography, Patient reported~     outcome assessment (Oxford Ankle Foot Questionnaire), and pain (measured by visual analog~     scale and numerical range scale).~   "
137263|NCT01770561|"~     The purpose of this study is to collect performance data on the integrated sensor and~     infusion set during 3 days of use and demonstrate performance adequacy of the Integrated~     sensor and infusion set with glucose sensing and insulin delivery functionalities. The~     hypothesis of this study is that having the infusion of insulin in close proximity to the~     sensor does not interfere with the sensor accuracy.~   "
137266|NCT01770522|"~     It is well known that being overweight or obese increases the risk of health problems, and~     that many people find it difficult to maintain a healthy weight. Worryingly the rise in~     obesity is greater in women than in the male population. One possible reason for this is that~     some women gain too much weight during their pregnancy and find it difficult to lose this~     weight after the birth of their baby. For example, women who gain more weight than~     recommended during pregnancy have been shown to be more likely to carry excess that weight at~     1 and 15 years after pregnancy, compared to women who gained the recommended amount of~     weight.~      There are currently no evidence-based guidelines in the UK for how weight should be managed~     during pregnancy. For these reasons, it is really important that we understand the factors~     affecting weight management before, during and after pregnancy.~      The aim of this research is therefore to find successful approaches to help women manage~     their weight before, during and after pregnancy. This will be completed by understanding the~     knowledge, attitudes, experiences and expectations of women during and after pregnancy and to~     identify the factors (e.g. diet, physical activity, poor social network etc.) which influence~     body weight. This will enable us to suggest better strategies for promoting healthy weight~     changes during and after pregnancy.~   "
137267|NCT01770509|"~     Ulcers of the lower extremities, caused by chronic venous insufficiency and cellulitis are~     common in patients older than 65 years and cause a significant morbidity.~      Natural Matrix Bio polymer Membrane (NMBM) is a novel topical cosmetic cream containing a mix~     of natural waxes, sugars and lipids. The aim of this study is to test whether of Natural~     Matrix Bio polymer Membrane (NMBM) is effective as an adjunctive therapy to the treatment of~     venous stasis and post-erysipelas leg ulcers.~   "
137268|NCT01770496|"~     The objective of this study was to assess the relative effectiveness of reminder/recall~     strategies among children who live in an urban area targeting alternative age-specific~     milestones.~   "
137269|NCT01770483|"~     The purpose of this study is to investigate if nitazoxanide used in combination with~     interferon alfa and ribavirin is effective in treating Hepatitis c infected type 2 Diabetic~     patients by improving their sustained viral response by more than 80%.Considering that the~     study is being conducted in a third world country like Pakistan, the standard treatment of~     hepatitis C is not cost effective. The aim is to introduce a new treatment comparable in~     efficacy to peginterferon and also cost effective.~   "
137270|NCT01770470|"~     The purpose of the pilot study is to determine the impact of short-term administration of~     chitosan-containing chewing gum on phosphate levels in patients with elevated serum phosphate~     levels.~   "
137271|NCT01770457|"~     This study is designed to examine the early sequential cytokine responses during antibiotic~     therapy and resuscitation of septic shock in relation to clinical manifestations of disease.~      The specific objective is to obtain sequential serum samples from patients with septic shock,~     examine a broad range of cytokine responses (TNF, IL-1, IL-6, MIF, LIF, HMGB1, etc) in a~     rigorous manner and correlate these responses to administration of antibiotics, resuscitative~     efforts and physiologic responses to illness (temp, HR, blood pressure, WBC, etc).~   "
137272|NCT01770444|"~     This study is to see whether the low-dose coronary computed tomographic angiography (CCTA)~     protocol is as safe and efficacious as conventional-dose protocol in early triage of acute~     chest pain.~   "
137273|NCT01770431|"~     To evaluate the efficacy and safety of Huaier Granule for prevention of recurrence and~     metastasis of hepatocarcinoma after radical hepatectomy.~   "
137274|NCT01770418|"~     The purpose of this research study is to compare the effects (good and bad) on subjects and~     their cancer using standard chemotherapy in combination with hypofractionated proton~     radiation therapy. Hypofractionation is a technique that delivers higher daily doses of~     radiation over a shorter period of time.~   "
137275|NCT01770405|"~     This study focuses on four different lesions: pancreatic cysts, lymph nodes near the~     gastrointestinal tract, pancreatic masses and GIST tumors.~      On one hand, the results obtained during previous studies are more advanced for the~     assessment of the diagnostic performance of Cellvizio needle-based Confocal Laser~     Endomicroscopy (nCLE) system for Pancreatic cysts. Safety and technical feasibility have~     already been performed, and an interpretation criteria classification exists. On the other~     hand, results for pancreatic masses, Lymph nodes and GIST are less developed.~      the objectives of the study are to~        -  Assess the diagnostic performance of the Cellvizio needle-based Confocal Laser~          Endomicroscopy (nCLE) system in diagnosing masses and cystic tumors of the pancreas,~          lymph nodes, submucosal lesions of the GI tract~        -  Define/Validate descriptive criteria of nCLE sequences in masses and cystic tu-mors of~          the pancreas, lymph nodes, submucosal lesions of the GI tract~   "
137276|NCT01770392|"~     To investigate the effect of the P-gp inducer rifampicin on the pharmacokinetic parameters of~     nintedanib~   "
137277|NCT01770379|"~     This study will provide efficacy and safety data of the secukinumab pre-filled syringe (PFS)~     for subcutaneous self-administration in patients with active rheumatoid arthritis who are~     intolerant to or have had an inadequate response to anti-TNF-α agents.~   "
137278|NCT01770366|"~     Obesity affects over one-third of the US population, and is associated with serious medical~     problems like diabetes and heart disease. Weight loss surgery is the most effective treatment~     for obesity, but some weight loss surgery patients lose less weight than others, and some~     patients regain the weight they lost. Researchers have found that support groups help~     post-surgical patients lose more weight, but long-term support programs often aren't~     available or are difficult for patients to get to. Physical activity is also important for~     weight loss surgery patients, but most post-surgical support programs don't focus on helping~     patients exercise. Our pilot study will test an Internet-based weight loss surgery support~     program that patients can use from home, and will include new devices such as wireless weight~     scales and wireless pedometers to help patients track their weight loss and physical activity~     and share their progress with their clinicians over the Internet. If successful, our support~     intervention will help more patients successfully lose weight after surgery, and therefore~     will improve their long-term health.~   "
137279|NCT01770353|"~     This is a Phase I study to understand the biodistribution of MM-398 and to determine the~     feasibility of using Ferumoxytol as a tumor imaging agent.~   "
137283|NCT01770301|"~     Bevacizumab (called also Avastin ®) is a medicine preventing the creation of new blood~     vessels (a process called angiogenesis). This can reduce blood flow of the tumor and then~     decreasing the contribution of nutriments and oxygen to the cancer cells and prevent the~     tumor from growing.~      In various types of cancers, as lung, breast, colorectal and renal cancer, addition of the~     bevacizumab to chemotherapy allowed to improve the disease outcome. The bevacizumab already~     benefits from a marketing authorization (MMA) for these various types of cancers.~      The bevacizumab has also obtained MMA for the treatment of the ovarian cancer in its most~     frequent histological form (ovarian carcinoma). Clinical trials conducted in this indication~     demonstrated the importance to pursue the treatment by bevacizumab after the chemotherapy is~     ended.~      This anti-angiogenic medicine is thought to be of a potential interest in sex cords- stromal~     since this tumors are very well vascularized.~      The ALIENOR study aims to explore the interest and the clinical benefit of associating~     bevacizumab to the paclitaxel in order to treat patients suffering from recurring sex cords-~     stromal tumor treated beforehand by platinum chemotherapy~   "
137284|NCT01770288|"~     During anaerobic exercise, the metabolic pathway of glycolysis is used in order to produces~     high-energy compounds adenosine triphosphate (ATP).The level of lactic acid in the blood is a~     marker to the increased protons concentration and acidosis.nevertheless, the increased level~     of protons in addition to the release of bradykinin causes pain during the exercise that~     limited the subject's performance. Therefore, it is assumed that the individual pain~     sensitivity might determine the subject's performance.~      Aims: To investigate the role of the DNIC efficiency in prediction of anaerobic performance~     in humans (2) to study the role of peripheral pro-nociceptive processing in mediating pain~     during anaerobic exercise and its contribution to the subjects' performance (3) to assess the~     function of pain-related psychological factors in anaerobic performance.~   "
137285|NCT01770275|"~     Background. The aim of our study was to investigate the ability of the Seventh edition of the~     classification by the International Union Against Cancer (UICC) to identify patients at~     higher risk and to predict the overall survival in patients with esophageal carcinoma.~     Methods. Demographic and clinical data of 605 patients, who underwent esophagectomy for~     esophageal carcinoma between 1992 and 2009, were analyzed. Tumor stage and grade were~     classified according to the sixth and seventh editions of the UICC classification.~   "
137286|NCT01770262|"~     Lack in vitamin D reduces the absorption of calcium in the body, accelerates bone loss and~     may increase the risk of fractures due to osteoporosis. An algorithm that will allow~     immediate and non-invasive quantification of vitamin D levels will shorten the time of~     diagnosis, reduce lab costs and prevent hazards or discomfort to the patient associated with~     a blood test.~      The goal of the study is therefore to develop a non-invasive method for quantifying vitamin D~     levels in the body using spectroscopy.~      40 subjects will be recruited: 20 hospitalized patients in the rehabilitation department,~     diagnosed with osteoporosis and 20 healthy subjects. Spectroscopy will be used with visible~     light on the subject's skin and middle infrared (MIR) on the blood sample to find correlation~     with the chemical lab test results.~   "
137287|NCT01770249|"~     This study is to evaluate outcomes of a less invasive surgical procedure for the treatment of~     achalasia.~   "
137288|NCT01770236|"~     The purpose of this study is to compare postoperative pain control after minimally invasive~     coronary artery bypass grafting for patients who receive an intercostal block (an anesthetic~     medicine injected in an area under the ribs) in the operating room and IV acetaminophen~     (Tylenol) to those who receive an intercostal block and On-Q pain pump catheter (a balloon~     pump attached to 2 small tubes near your procedure site that automatically delivers pain~     medicine).~   "
137289|NCT01770223|"~     This study is being done to find out if participants with insulin resistance and hepatitis C~     virus genotype 1 (HCV GT1) infections who failed dual therapy with peginterferon alfa~     (PegIFN) + ribavirin (RBV) will benefit from the addition of boceprevir to PegIFN + RBV~     (triple therapy).~   "
137290|NCT01770210|"~     In western societies hypercholesterolemia is one of the major and independent factors that~     predispose to cardiovascular disease and death from them. According to the clinical study~     ATTICA, conducted during the years 2001-2002, in which randomized 1514 men and 1528 women,~     rates of hypercholesterolemia observed in a sample of urban population was 39% for men and~     37% women . The prevalence in the corresponding U.S. epidemiological study NIANES was 52% for~     men and 49% women. The relationship between cholesterol, lipid-lowering therapy and risk of~     cardiovascular disease appears to be quite clear in the secondary prevention trials, the 4S~     (Scandinavian Simvastatin Survival Study), CARE (Cholesterol And Recurrent Events) and LIPID~     (Long-term Intervention with Pravastatin in Ischemic Disease) which showed the benefits of~     lowering LDL cholesterol in patients with coronary artery disease. Despite these remarkable~     results, studies were secondary prevention as a major shortcoming, the lack of patients with~     acute coronary events. This gap came to cover the study MIRACL (Myocardial Ischemia Reduction~     with Aggressive Cholesterol Lowering). In MIRACL study , atorvastatin 80 mg was evaluated in~     3,086 patients (atorvastatin n = 1.538, placebo n = 1.548), acute coronary syndrome~     (myocardial infarction without Q-wave or unstable angina). Treatment was initiated during the~     acute phase after hospital admission and lasted for a period of 16 weeks. Treatment with~     atorvastatin 80 mg / day increased the latency of the combined primary endpoint, defined as~     death from any cause, nonfatal myocardial infarction, resuscitated cardiac arrest, or angina~     with objective evidence of myocardial ischemia requiring admission to hospital, indicating a~     risk reduction of 16% (p = 0,048). This was mainly due to a 26% reduction in~     re-hospitalization for angina with objective evidence of myocardial ischemia. The other~     secondary endpoints were not statistically significant by themselves (total: placebo: 22.2%,~     Atorvastatin: 22.4%).~      Statins by reducing coronary syndromes, it appears that contribute to reducing the incidence~     of cardiovascular diseases. This is exactly what was observed in 4S, in which the incidence~     of chronic heart failure (CHF) during follow-up was 10.3% for those who received placebo and~     8.3% in the simvastatin group, a finding which translates 19% reduction in heart failure (P~     <0,015) nationwide with the appearance episode (event) CV.~   "
137291|NCT01770197|"~     The time window for intravenous recombinant tissue plasminogen activator treatment in~     ischemic stroke patients has been extended to 4.5h. Little is known about intravenous~     recombinant tissue plasminogen activator use in the 3-4.5 hour time window among Chinese~     stroke patients. This exploratory study was to describe the feasibility and outcome of~     treatment with intravenous recombinant tissue plasminogen activator in the expanded time~     window, and to offer suggestions for future clinical work in China.~   "
137304|NCT01770028|"~     The primary aim of the proposed study is to determine whether lifestyle interventions to~     prevent excessive gestational weight gain in overweight/obese pregnant women have positive~     ripple effects on untreated partners in the home. We hypothesize that partners of pregnant~     women randomized to the lifestyle intervention, relative to those of standard care, will have~     greater weight losses through 12-months. Secondary aims examine partner improvements in~     weight control behaviors, the home environment, and psychosocial parameters.~   "
137292|NCT01770184|"~     Individuals who have a mild stroke have a 44% risk of dying from a second stroke within 10~     years which is in large part due to the cyclical relationship of chronic disease, poor~     health, and mild stroke which has gone largely unnoticed in the United States.~     Self-management intervention has been proven to be an effective intervention to increase~     healthy behaviors, improve overall health status, decrease healthcare utilization/cost,~     decrease depressive symptoms, and improve participation in people with a variety of chronic~     conditions; however, it has never be used with individuals with mild stroke. The critical~     next step and goal of this study is to evaluate if self-management intervention will improve~     health outcomes for persons with mild stroke. The overall hypothesis of this study is that~     self-management intervention will improve outcomes in the mild-stroke population.~   "
137293|NCT01770171|"~     Wright et al (Anticancer Res, 2000) reported the results of a retrospective study on 11~     patients with advanced/recurrent endometrial cancers. All patients had multi-site disease and~     were heavily pretreated with a median of 3 prior chemotherapy regimens. All received~     bevacizumab combination therapy which was well-tolerated. Two patients had partial responses,~     3 had stable disease, while 5 patients progressed. One subject was not assessable for~     response. The median progression-free interval was 5.4 months for the entire cohort and 8.7~     months for those who achieved clinical benefit (PR or SD). The authors concluded that~     Bevacizumab was well-tolerated and displayed promising anti-neoplastic activity in patients~     with endometrial cancer.The rationale for combining anti-angiogenic agents, including~     anti-VEGF antibodies, with cytotoxic chemotherapy stems from a number of preclinical studies~     showing additive and synergistic anti-tumour activity in a number of solid tumour types. By~     combining VEGF-targeting agents such as bevacizumab with conventional chemotherapies, it is~     hoped that these agents will act synergistically, thereby enhancing their anti-tumour~     efficacy and controlling disease progression.~      The addition of bevacizumab to chemotherapy has been shown to improve PFS and/or OS in a~     series of large, randomized Phase III clinical trials in a wide range of tumour types,~     including mCRC, non-squamous NSCLC, metastatic BC (mBC) and mRCC.~   "
137294|NCT01770158|"~     This is a non-interventional multi-center study (NIS) in adult patients with AML in first~     complete remission with measurable minimal residual disease (MRD). Patients are eligible when~     gene status was already determined for previous induction and consolidation therapy of AML~     and showed carrier of NPM1, CBFβ-MYH11, or MLL-AF9 mutation. The study objective is to~     observe the impact of pre-emptive therapy with histamine dihydrochloride (HDC) and~     interleukin-2 (IL-2) with regard to assess leukemia-free survival/time to relapse and to~     monitor MRD level trend over time. HDC and IL-2 are approved drugs for AML patients in first~     complete remission. Therapy is administered for 10 treatment cycles as outlined in the~     Summary of Product Characteristics.~   "
137295|NCT01770145|"~     This study is designed to assess the effect of APOKYN treatment in rapid and reliable~     improvement of motor symptoms in Parkinson's disease (PD) subjects suffering from delayed or~     unreliable onset of levodopa (L-dopa) action.~   "
137296|NCT01770132|"~     This phase I trial studies the side effects and best dose of ultrasound-guided photodynamic~     therapy with porfimer sodium when given together with gemcitabine hydrochloride in treating~     patients with locally advanced pancreatic cancer. Photodynamic therapy uses a drug, porfimer~     sodium, that becomes active when it is exposed to a certain kind of light. When the drug is~     active, cancer cells are killed. Drugs used in chemotherapy, such as gemcitabine~     hydrochloride, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. Giving photodynamic therapy together with~     gemcitabine hydrochloride may be effect in patients with pancreatic cancer.~   "
137297|NCT01770119|"~     Measles is a vaccine-preventable disease, which can be life-threatening in immunosuppressed~     children. Currently, measles vaccine is not recommended in pediatric orthotopic liver~     transplant recipients, because it is a live-attenuated vaccine.~      We want to assess the influence of immunosuppression on immunity against measles in~     previously vaccinated children and to evaluate the induction of B cell and T cell response~     against measles elicited by vaccination in children at least 12 months after transplantation.~   "
137298|NCT01770106|"~     The aim of this study is to compare the effects of denosumab and a current standard treatment~     on cortical and trabecular microarchitecture at the radius and second metacarpal in~     rheumatoid arthritis (RA) patients with low bone mineral density using high resolution~     peripheral quantitative computed tomography (HR-pQCT) during a 6-month open-label randomized~     controlled study. Forty ambulatory Chinese females, who consent to receive alendronate as~     standard treatment subjective to the randomization, will be enrolled in this study. Subjects~     will be randomized to 2 arms receiving: 1) subcutaneous injection of denosumab 60mg (Prolia®)~     every 6 months (n=20), or 2) oral alendronate weekly (Fosamax® once weekly 70 mg, n=20). In~     addition, all patients will be given a daily calcium supplement (1500mg caltrate /day) and 1~     multivitamin tablet per day. Efficacy and safety assessment will be performed at baseline,~     month 3 and month 6. aBMD of lumbar spine, total hip and non-dominant distal radius will be~     measured using dual-energy X-ray absorptiometry (DXA) and microarchitecture of bone is~     measured at the non-dominant distal radius and the second metacarpal bone of the non-dominant~     hand using HR-pQCT.~   "
137299|NCT01770093|"~     Several studies have been conducted throughout the world to evaluate patients' and parents'~     preferences regarding physicians' attire. Most studies have shown that the attire influences~     their feelings trust and confidence regarding their care. In most countries the preference is~     for formal attire. In other places a more casual attire is generally accepted. Israel is a~     country where casual dress is acceptable in most settings. Israeli physician's dress code has~     been discussed in the past, but has never been systematically studied. The aim of this study~     is to systematically examine the attitudes of parents of children who have been admitted to~     the pediatric ward towards physicians' attire.~   "
137300|NCT01770080|"~     Efficacy and safety of Euminz® (10% ethanolic solution of peppermint oil for topical use)~     compared to placebo in patients with episodic tension-type headache (ETTH).~      Prospective, double-blind, placebo-controlled, phase IV clinical trial; Parallel-groups~     design; Randomisation 1:1; First attack per patient will be evaluated for primary objectives,~     following attacks during study duration will be observed and documented.~      Study duration per patient: 10 weeks~   "
137305|NCT01770015|"~     Ventilator acquired pneumonia (VAP) are severe nosocomial infections. On the other side,~     bronchial fungi colonization is commonly observed in ICU; therefore, the investigators~     propose to study the role of bronchial fungi colonization on the occurrence of VAP taking~     into account the immune status of the patient and the antibiotic and antifungal treatments he~     has received.~   "
137306|NCT01770002|"~     The investigators hypothesize that everting wound edges while suturing surgical sites will~     result in more aesthetic scars. Additionally, we also hypothesize that small to moderate~     wound irregularities present at 3 months will resolve by 6 months after surgery with no~     intervention~   "
137307|NCT01769989|"~     The purpose of this study is to determine if electrodermabrasion improves the cosmetic~     appearance of raise or bumpy scars or scars that are a different color or texture than the~     surrounding skin resulting from dermatologic surgery and whether it is as good as to the~     already used method of dermabrasion.~   "
137308|NCT01769976|"~     The aim of this study is to examine whether periodic fasting improves markers of diabetes~     risk and cardiovascular health, and will compare this to the effects observed with daily~     dieting by energy restriction, and also with no change in energy intake.~      It is hypothesized that periodic fasting, with or without weight loss, will be as effective~     as daily energy restriction to improve markers of metabolic health and energy metabolism.~   "
137309|NCT01769963|"~     The purpose of the study is to learn more about how advanced glycation end-products can~     affect insulin resistance, inflammation and blood vessel health in people with kidney~     disease.~   "
137310|NCT01769950|"~     Nodal involvement among patients with prostate cancer is known to be a poor prognostic~     factor. Traditionally, the presence or absence of nodal disease in patients with prostate~     cancer is ascertained with the use of anatomical imaging methods such as computed tomography~     (CT) and magnetic resonance imaging (MRI).~      However, the sensitivities of CT and MRI for the detection of pelvic nodal disease is rather~     low, with reports placing the value to lie between 50-80%.~      Positron emission tomography (PET) with the use of carbon-11 or fluorine-18 tagged choline~     (Choline-PET) is an approach which is known to deliver a high sensitivity for the imaging of~     prostate cancer disease burden in the primary, nodal and the metastatic areas.~      The investigators in this prospective trial intend to utilize Choline-PET among all newly~     diagnosed patients of prostate cancer who are presumed to be non-N1 (absence of nodal disease~     on conventional imaging) and non-M1 (absence of metastatic disease on conventional imaging).~   "
137311|NCT01769937|"~     Systemic lupus erythematosus is a serious and potentially life-threatening condition with~     significant unmet medical need. The aim of this Investigator Initiated, single center,~     open-label study is to evaluate the efficacy and safety of a daily subcutaneously (SQ)~     injection of H.P. Acthar Gel for 10 days with an optional 5 day rescue period for~     non-responders after day 10 dose. The primary objective of this study is to evaluate whether~     the addition of H.P. Acthar Gel to standard treatment of lupus will ameliorate the intensity~     of flares as measured by changes in SLEDAI score, Patient and Physician global assessments.~   "
137312|NCT01769924|"~     Studies of patients with established kidney disease, even when this is mild, appear to show~     that they are at high risk of heart failure, stroke and sudden cardiac death. This may be~     because kidney disease causes stiffening of the arteries in the body which means that the~     heart and brain are damaged by high blood pressure. By studying patients before and after the~     removal of a kidney (uni-nephrectomy) for transplantation the investigators will find out for~     the first time in man the effect of an isolated reduction in kidney function on the structure~     and function of the cardiovascular system.~   "
137313|NCT01769911|"~     This clinical trial studies genetically modified peripheral blood stem cell transplant in~     treating patients with HIV-associated non-Hodgkin or Hodgkin lymphoma. Giving chemotherapy~     before a peripheral stem cell transplant stops the growth of cancer cells by stopping them~     from dividing or killing them. After treatment, stem cells are collected from the patient's~     blood and stored. More chemotherapy or radiation therapy is then given to prepare the bone~     marrow for the stem cell transplant. Laboratory-treated stem cells are then returned to the~     patient to replace the blood-forming cells that were destroyed by the chemotherapy and~     radiation therapy~   "
137314|NCT01769898|"~     The purpose of this study is to examine the efficacy and safety of 24 weeks treatment with~     theophylline plus low-dose formoterol-budesonide in subjects with bronchiectasis.~   "
137315|NCT01769885|"~     This clinical trial studies tivozanib before surgery in treating patients with localized~     kidney cancer. Tivozanib may stop the growth of tumor cells by blocking some of the growth~     factors needed for cell growth.~   "
137316|NCT01769872|"~     The purpose of this study is to investigate the efficacy and safety of autologous~     transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with~     spinal cord injury~   "
137317|NCT01769859|"~     The primary goals of this work are: a) to establish a unique collection of mood disorder~     patients across the life cycle, including children, adults and geriatric patients, with~     well-defined medical co-morbidities and medication treatment outcomes at the University~     Hospitals Case Medical Center Department of Psychiatry; b) to establish a collection of~     nuclear families, including both mothers and fathers, of children diagnosed with mood~     disorders; c) to perform a systematic genetic analysis of the proposed sample repository to~     identify genes and genetic variants contributing to inter-patient variability in clinical~     phenotypes and treatment responses. Our primary hypothesis is that genetic variations may~     underlie individual variability in disease susceptibility, clinical phenotypes and treatment~     safety, tolerability, and effectiveness.~   "
137318|NCT01769846|"~     Advances in intensive care and mechanical ventilation (MV) in the past two decades have~     increased critically ill patient survival. However, some patients require prolonged MV (PMV)~     and are deconditioned due to respiratory insufficiency caused by underlying disease, adverse~     effects of medications, and prolonged immobilization. Patients in the intensive care unit~     (ICU) are often confined to their beds, which results in inactivity, immobility, and severe~     osteomyoarticular system dysfunction. Our hypothesis is that an early mobilization protocol~     improves muscle thickness (MT) of the quadriceps femoris, peripheral muscle strength,~     perceived functional status, gait speed, quality of life, duration of mechanical ventilation,~     ICU length of stay of the critically ill patient.~      The purpose of this study is to evaluate the effects of implementation an early mobilization~     protocol in critically ill patients in the Intensive Care Unit of the University Hospital of~     Santa Maria.~   "
137319|NCT01769833|"~     This study proposes to compare the effect of 48 weeks exposure to pegylated interferon alpha~     vs. nucleoside analogue (NA) on hepatitis B e antigen (HBeAg) seroconversion and HBsAg levels~     in nucleoside analogue controlled HBeAg-positive chronic hepatitis B (CHB) patients who have~     an undetectable hepatitis B virus (HBV) viral load at least 1 years.~   "
137320|NCT01769820|"~     This study builds on previous research which has provided compelling evidence that deficient~     activity of glucocorticoids in the endometrium is a cause of increased menstrual bleeding.~     This study aims to demonstrate that a glucocorticoid (dexamethasone), already in common use~     for other conditions, (eg to treat medical conditions such as asthma and rheumatoid arthritis~     in early pregnancy), will reverse the endometrial glucocorticoid deficiency and as a result~     reduce menstrual blood loss.~      The study is in two stages, a 12 month workup stage and a 3 year, response adaptive,~     dose-finding randomised controlled trial. The first stage involves two workup clinical~     studies to gather preliminary safety and efficacy data from first-in-Heavy Menstrual Bleeding~     use of oral dexamethasone. They will also provide methodological data for a series of~     simulation studies to determine a robust adaptive trial design specification.~      Workup study 1: is unblinded, six patients will be given Dexamethasone (0.75mg twice daily)~     for 5 days during two consecutive menstrual cycles and will have an endometrial biopsy and~     MRI on two occasions (in a nontreated cycle, and the second of the cycles treated with~     Dexamethasone). Workup study 2; is a doubleblind crossover trial of 14 women -2 treatment~     blocks of two cycles each, with either placebo or Dexamethasone (0.75mg twice daily),~     randomised to order of treatments blocks - placebo then Dexamethasone, or vice-versa.~      Adaptive trial: 54 month double-blind, placebo controlled trial of 108 women to evaluate the~     effect of Dexamethasone across a range of doses with the aim of identifying the optimal dose~     to be studied in a subsequent Phase III trial.~      Participants will be randomised to receive one of 6 active doses or placebo over 3 menstrual~     cycles.~      All studies will involve asking participants to complete menstrual diaries and to carry out~     menstrual blood loss collections to objectively measure blood loss.~      The investigators' proposed approach is novel use of synthetic glucocorticoid to rescue~     luteal phase deficiency of cortisol, and thus improve endometrial vasculature and hence~     vasoconstriction when menses commences, and thus reduce menstrual bleeding.~   "
137321|NCT01769807|"~     Reduced plasma nitrate (NOx) levels and increased urinary norepinephrine (U-NE) levels have~     been described in severe obstructive sleep apnea (OSA), and are reverted by continuous~     positive airway pressure (CPAP). The investigators wanted to know the effect of CPAP on these~     biomarkers in mild-moderate OSA.~   "
137322|NCT01769794|"~     The study is aimed to evaluate the effectiveness and safety of Jinlianqingre Effervescent~     Tablets, a traditional Chinese medicine (TCM), in the treatment of Uncomplicated hand, foot,~     and mouth disease (HFMD).~   "
137323|NCT01769781|"~     The aromatase inhibitor (anastrazole) plus long acting GnRH agonist leuprolide acetate will~     be tested for the treatment of women with endometriosis recurrence compared with classical~     GnRH analog treatment. Pain symptom disappearance and disease free time during follow-up will~     be the outcomes for establishing which medical treatment is the best in endometriosis~     recurrence treatment.~   "
137324|NCT01769768|"~     This is a multi center, open-label study to evaluate the drug-drug interaction of LDE225 on~     the PK of bupropion and warfarin patients with advanced solid tumors. Subjects will receive~     800mg daily of LDE225 and two separate doses of either bupropion or warfarin.~   "
137325|NCT01769755|"~     To assess the safety and efficacy of intravenous (IV) PDA001 infused every two weeks for up~     to 5 total infusions in subjects with Crohn's disease who are refractory to one or more~     standard Crohn's disease therapies.~   "
137326|NCT01769742|"~     Hospital acquired pneumonia (HAP) is a common complication of extended hospital stay. In~     surgical specialities and critical care early physiotherapy is a recognised way of preventing~     such infections, and reducing length of hospital stay (LOS), however prevention of this~     problem is less well studied in medical inpatients.~      The investigators propose a pilot study to assess the impact of introducing an early~     mobilisation strategy to general medical and respiratory wards at an acute Trust in the~     United Kingdom (UK). The investigators will recruit all new admissions to each of 2~     respiratory and 2 elderly care wards - 1 of each ward type will be allocated to receive extra~     physiotherapy input targeting new admissions for early mobilisation. Patients' usual~     mobility, current mobility and actual activity levels will be studied by accelerometer and~     simple patient questionnaire in the first 48 hours of admission, and compared between groups.~     Incidence of HAP and total LOS will be recorded and compared between groups.~      The investigators hypotheses are that the physiotherapy intervention will increase activity~     levels, reduce incidence of HAP and reduce LOS. The latter may result in cost savings to the~     National Health Service (NHS), which the investigators will model using local tariff data.~      The investigators plan to use our data to power a larger randomised controlled study, or if~     the intervention is a marked success, such that a control group would be unethical, then a~     wider service development and evaluation programme.~   "
137327|NCT01769729|"~     The overall aim of this program of research is to develop a collaborative psychotherapy for~     major depressive disorder (MDD) specifically for primary care patients with MDD and comorbid~     chronic low back pain (CLBP).~      The purpose of the proposed project is to establish the feasibility and acceptability of a~     research design for an eventual large-scale randomized clinical trial which would test the~     efficacy of PEPP in comparison to a control condition (depression care management).~      To achieve the investigators specific aims, the investigators will conduct a pilot randomized~     clinical trial (n = 30), with two treatment arms; PEPP (which includes procedures used in~     care management) or care management.~   "
137328|NCT01769716|"~     This open-label study aims to evaluate the safety and efficacy of autologous or allogeneic~     umbilical cord blood therapy for children with global developmental delay.~   "
137343|NCT01769521|"~     Interplay between the increasing IOP and decreasing blood pressure (BP) during the 24-hour~     period, especially in the nocturnal period, may lead to insufficient perfusion pressure of~     the optic nerve and contribute to the glaucomatous damage in adjunct to the antero-posterior~     vectorial mechanical impact on the lamina cribrosa, the translaminar pressure. Patients with~     progressive VF loss showed greater nocturnal BP dips than patients with stable VF. Reduced~     mean intraocular perfusion pressure (IOPP) was significantly associated with the extent of~     glaucomatous damage. How the nycthemeral IOP fluctuation influences glaucoma progression has~     not been studied in a prospective manner and remains to be elucidated.~      The purpose of this study is to assess the relationship between the 24-hour IOP fluctuation~     pattern and the 24-hour BP pattern in patients with primary open angle glaucoma (POAG). IOP~     fluctuations will be monitored with SENSIMED Triggerfish®, a portable investigational device~     using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours.~   "
137527|NCT01767129|"~     To evaluate the efficacy, safety, and tolerability of AVP-923 capsules containing 45 mg~     dextromethorphan and 10 mg quinidine (AVP-923-45) compared to placebo for the treatment of~     levodopa-induced dyskinesia (LID) in patients with Parkinson's disease (PD).~   "
137329|NCT01769703|"~     Objective: Demonstrate the safety of early use of dabigatran following TIA/minor stroke.~      Background: Although aggressive antithrombotic therapy has been shown to reduce the number of~     new ischemic events following stroke/TIA, this has always been offset by an increase in the~     risk of hemorrhagic transformation. Dabigatran is much safer than previously tested~     antithrombotic agents, with respect to intracranial bleeding and therefore offers a unique~     treatment opportunity in these high-risk patients. TIA/minor stroke represent the largest~     group of cerebrovascular disease patients. A short-term intervention such as 30 days of~     dabigatran treatment has the potential for a very large impact from the population health~     perspective, given the number of patients who may be treated if a benefit can be~     demonstrated.~      Study design:~      This is an open label, single arm study. Patients with TIA/minor stroke (National Institutes~     of Health Stroke Scale (NIHSS) score </=3) who can be treated within 24 hours of symptom~     onset will be eligible. All patients will be treated with dabigatran for 30 days. The dose of~     dabigatran will be determined by age and renal function (patients >80 years old and/or with~     GFR 30-50 ml/min will received 110 mg bid, and all other patients will receive 150 mg~     BID).The primary endpoint is symptomatic hemorrhagic transformation. Patients (n=50) with~     TIA/minor stroke, defined as having a National Institutes of Health Stroke Scale Score of~     </=3, will undergo an MRI, including diffusion-weighted imaging (DWI), as well as gradient~     recall echo (GRE) sequences, which will be used to assess for hemorrhagic transformation.~     Patients will have a repeat MRI examination at 7 and 30 days to assess for hemorrhagic~     transformation and new lesion development. The primary endpoint of of phase I is symptomatic~     hemorrhagic transformation, defined as a parenchymal hematoma on the day 7 MRI scan (GRE~     sequence), associated with clinical worsening (>/=4 point increase in National Institutes of~     Health Stroke Scale (NIHSS) score).~      If dabigatran can be used safely in this population, a second phase aimed at demonstrating~     the rate of new ischemic lesion development following TIA can be reduced with aggressive~     antithrombotic therapy. A randomized open-label, blinded endpoint evaluation design will be~     employed. The investigators hypothesize that dabigatran therapy administered within 24 hours~     of symptom onset will reduce the rate of new ischemic lesions, relative to standard care, one~     week and 30 days after onset.~   "
137330|NCT01769690|"~     The study design is a within-subject randomized cross-over design to evaluate the effects of~     DBS on sleep architecture, as measured by polysomnography, and on wake-time vigilance, as~     measured by a virtual reality street-crossing simulator.~   "
137331|NCT01769677|"~     The primary objective of this study is to assess the bioequivalence of two 45-mg hydrocodone~     bitartrate extended-release tablets and one 90-mg hydrocodone bitartrate extended-release~     tablet.~   "
137332|NCT01769664|"~     The objective of this study is to compare the relative efficacy and safety of the test~     formulation Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Taro Pharmaceuticals Inc.) to the~     marketed formulation Duac® Topical Gel (Clindamycin 1%/Benzoyl Peroxide 5%) (Stiefel) in the~     treatment of the inflamed lesions of acne vulgaris. Both the test and reference formulations~     will also be compared to a placebo formulation to test for superiority.~   "
137333|NCT01769651|"~     Accurately predicting the risk factors of patients' suffering a drug overdose plays a crucial~     role in effective prevention of drug overdose. In order to investigate possible risk factors~     for drug overdose, the NHS Fife Research & Development Office funded this project to be~     carried out by a group of researchers based in the University of St Andrews, in collaboration~     with the NHS Fife Addiction Services.~      To improve our understanding of drug misusers' risk of suffering a drug overdose, the~     investigators focus on the factors that are associated with the aspects of the addiction~     consultation process (e.g. verbal and non-verbal behaviours of clinicians and patients). The~     investigators are particularly interested in how clinicians recognize and manage patients'~     emotional concerns during consultations. Based on the empirical evidence in the area of~     patient-centred consultation, the investigators hypothesize that successful management of~     patient emotional distress is positively correlated with improved healthcare outcomes~     including patient's feeling more emotionally valued and satisfied with the consultation. The~     investigators also hypothesize, according to the research findings on the relationship~     between facial expressions and suicidal reattempt, that some non-verbal behaviours during~     consultation (e.g. patient's 'looking down' activity) are related to patient's risk of~     suffering a drug overdose.~      After obtaining informed consent from clinicians and patients, the investigators will video~     record a patient's first consultation session with a key worker within the NHS Fife Addition~     Services. The investigators expect to collect a minimum of 16 consultations (about eight~     clinicians with two patients per staff member) for this one-year pilot study. A validated~     coding scheme will be modified to code patients' expressions of emotional distress and~     clinicians' responses. Additional survey method will be also employed to collect demographic~     information and patient satisfaction. The investigators hope the findings of the study will~     improve our understanding of drug overdose risk factors and contribute to the development of~     drug overdose prevention programmes.~   "
137334|NCT01769638|"~     This study investigates safety and pharmacokinetic comparison of Seoul Pharma's orally~     disintegrating film (ODF) formulation of sildenafil (test formulation) and Pfizer's Viagra®~     (sildenafil) Film Coated Tablet (FCT) formulation (reference formulation) in healthy~     volunteers.~   "
137335|NCT01769625|"~     This is a biomarker study with the goal of measuring changes in proteins and gene~     methylation. This study is not intended for use in diagnosing, mitigating, treating, curing,~     or preventing disease.~      The purpose of this study is to determine if Vitamin D (cholecalciferol) alone and in~     combination with celecoxib (Celebrex, a non-steroidal anti-inflammatory drug, or NSAID), act~     together to decrease breast cancer risk by their effect on certain biological indicators~     (biomarkers) of breast cancer risk (called PGE2, COX-2, and 15-PGDH) and cell changes in the~     breast.~   "
137336|NCT01769612|"~     The purpose of the study is to evaluate the sensitivity and specificity of CL Detect, in~     subjects with suspected CL in Tunisia.~   "
137337|NCT01769599|"~     there is no yet agreement about the best way to treat Diabetic Macular Edema (DME) the two~     options up to day are using Grid laser treatment Vs. Avastin injections or a combination of~     both in this study we want to compare the two attitudes.~   "
137338|NCT01769586|"~     Patients who are undergoing colonoscopy and are not adequately sedated after initial standard~     sedation with midazolam 5 mg and fentanyl 100 mcg will be randomly assigned to receive~     diphenhydramine vs. continued midazolam, and their level of sedation will be assessed. Our~     hypothesis is that diphenhydramine will provide better sedation than continued administration~     of midazolam during colonoscopy in patients not achieving adequate sedation with standard~     doses of midazolam plus fentanyl.~   "
137339|NCT01769573|"~     This research study will test different doses of RG-HRV16 to find the minimum dose needed to~     give research subjects cold symptoms of at least moderate intensity. The study will also test~     the safety of RG-HRV16. This information will be used in future studies (for example, to test~     antiviral preparations, sprays that could protect from getting a cold or decrease cold~     symptoms or to understand more about how rhinovirus can lead to asthma worsening). RG-HRV16~     is a common cold virus that has been made in a new way and has not been used in humans~     before.~   "
137340|NCT01769560|"~     This study will test whether a tailored, online educational intervention increases HPV~     vaccine uptake and intent among female college students.~   "
137341|NCT01769547|"~     This is a single-arm, open label, two stage, phase II study of dovitinib in patients with~     advanced Malignant Pleural Mesothelioma (MPM). The primary purpose of this study is to~     evaluate the potential efficacy of dovitinib in the second- or third-line treatment of MPM~     using progression free survival (PFS).~   "
137342|NCT01769534|"~     The purpose of this study is to follow patients, who have small mucinous cysts in the~     pancreas, prospectively over a 5-year period.~   "
140060|NCT01734096|"~     The purpose of this study is to determine whether in pre-hypertensive and hypertensive states~     such as white coat hypertension, obesity related hypertension or resistant hypertension,~     renal function is more sensitive to orthostatic stress.~   "
137344|NCT01769508|"~     With improvements in response rate and survival seen for HER2 positive patients treated with~     HER2 blockade in the metastatic setting, the use of HER2 blockade in the neoadjuvant setting~     to increase antitumor effect shows promise. Patients with previously untreated localized HER2~     positive esophageal, GE junction and gastric adenocarcinomas will be enrolled. Patients~     meeting all inclusion/exclusion criteria will receive neoadjuvant treatment with concurrent~     chemotherapy and radiation therapy beginning on day 1 of treatment. During the lead-in safety~     portion, the optimal dose of lapatinib will be determined.~   "
137345|NCT01769495|"~     Our hypothesis is that a rapid follow up for elderly patients in a Geriatric Clinic~     discharged from the Emergency Department (ED) will have fewer unplanned return ED visits and~     fewer unplanned hospital admissions with no attendant increase in mortality.~      Patients 75 years of age and older will be randomized following discharge from the ED into~     two groups. The first will receive standard post ED care. The second will receive an~     appointment to our Geriatric Clinic within 2-3 days for stabilization, further treatment and~     contact with the patient's primary physician to communicate the course of the patient's~     illness and to schedule subsequent follow-up with the patients regular medical provider.~      There will be two primary outcomes: The first will be a composite of morality and/or return~     to the ED at 30 days, and the secondary primary outcome will be mortality. Economic data~     regarding resource utilization by patients will also be analyzed.~   "
137346|NCT01769482|"~     Current therapeutic options for a well-recognized group of patients with anginal symptoms—a~     positive exercise tolerance testing, SPECT or perfusion defect in MRI but angiographically~     normal coronary arteries—are limited. The condition, referred to as microvascular angina~     (MVA) or cardiac syndrome X, is not as benign as originally reported—patients presenting with~     unstable angina and nonobstructive atherosclerotic coronary artery disease have a 2% risk of~     death or myocardial infarction at 30 days of follow-up. It is more common in women in whom~     the first presentation of angina occurs either perimenopausally or postmenopausally. Aberrant~     flow-mediated coronary vasomotion is pivotal in the pathogenesis (systemic) impairment in~     endothelial function. Indeed, some centers use systemic assessments of vascular function in~     their diagnostic pathways for this group of women. It was recently suggested that endothelial~     dysfunction may lead to myocardial ischemia.~      In the present study, the investigators tested the hypothesis that udenafil offers dual~     benefits of improving vascular function and lessening ischemia in women with angina,~     perfusion defect in cardiac MRI, and normal coronary arteries.~   "
137347|NCT01769469|"~     This is a prospective observational cohort sub-study of subjects enrolled in ATN 110 or ATN~     113, which is a prospective interventional trial.~   "
137348|NCT01769456|"~     Approximately 100 HIV-uninfected YMSM at high risk of acquiring HIV infection, between the~     ages of 15 and 17 inclusive will be enrolled across all participating Adolescent Medicine~     Trial Units (AMTUs). Subjects will complete the behavioral intervention selected by all~     participating sites, Personalized Cognitive Counseling (PCC), and will then be provided with~     open label emtricitabine (FTC)/tenofovir (TDF) (Truvada®) as pre-exposure prophylaxis (PrEP).~     Behavioral and biomedical data will be collected at baseline and at 0, 4, 8, 12, 24, 36 and~     48 weeks. Any subject who becomes HIV infected during the course of the study will be~     discontinued from the study agent and be followed for an additional 24 weeks after the study~     visit at which HIV infection is confirmed. Those subjects who meet specific bone or renal~     criteria at the Week 48 visit or the 24-Week HIV Seropositive visit will be followed for an~     additional 48 weeks in the Extension Phase to monitor longer-term outcomes of potential~     concerns.~   "
137349|NCT01769443|"~     The primary objective is to evaluate the efficacy of desensitization therapy, which includes~     VELCADE® (bortezomib) and plasmapheresis, on select sensitized patients awaiting heart~     transplantation.~   "
137350|NCT01769430|"~     The recent swine origin influenza pandemic (2009), new emergence of swine origin H3N2v, and~     delayed availability of vaccine for these agents highlight the need to test and optimize~     public health intervention strategies to reduce transmission of influenza. We will use a new~     technology for biological particle collection (U.S. Provisional Patent Application No.~     61/162,395, McDevitt et al., Aerosol Sci Technol 2013) to make fundamental observations on~     infectious respiratory droplets in a study of up to 200 naturally occurring seasonal~     influenza cases. We will collect respiratory droplets shed by participants while breathing~     normally, talking, and spontaneously coughing. We will characterize the size distribution of~     droplets containing infectious virus. We will use these basic data to examine the roles of~     large and small respiratory droplets and examine how the interaction of host factors and~     virus type impact the shedding of infectious respiratory droplets. Subjects will be recruited~     through a web based respiratory illness surveillance system, health clinics and advertisement~     in the campus community. Sitting in the collection booth will not create additional~     discomfort or risk for volunteers already suffering from influenza infection. We will recruit~     up to 1000 persons with symptoms of acute respiratory illness for screening with collection~     of nasopharyngeal swabs and questionnaire. From among those screened, we will recruit 250 to~     give exhaled breath samples, and ask 50 people with influenza to return for follow up exhaled~     breath samples on up to two subsequent days. We hypothesize that (1) fine aerosols (<5~     microns in aerodynamic diameter) will contain more viral copies than coarse aerosol particles~     (>= 5 microns) (2) fine aerosols will contain culturable virus indicating that the fine~     aerosols are infectious, (3) aerosol shedding will correlate with virus load measured by~     swabs, (4) presence of active cough during sampling will be associated with increased aerosol~     shedding, (5) clinical symptoms and signs, including fever can be used to predict viral~     aerosol shedding.~   "
137351|NCT01769417|"~     This is a Phase 1, first time in human study enrolling approximately 33 healthy adult~     subjects (18-65 yrs) from one study site. The purpose of this study is to evaluate the~     safety, tolerability and PK of MEDI4893 in healthy adult volunteers administered as a single~     IV dose compared with placebo, across 4 cohorts. The 4 dose cohorts will enroll sequentially.~     Subjects will be followed for safety from the time of Informed Consent through 360 days post~     dose.~   "
137352|NCT01769404|"~     This study has two parts. Each participant will receive a daily injection of LY2605541 during~     one treatment period and a daily injection of insulin glargine during one treatment period.~     Each treatment period is 2 to 3 weeks and is followed by a procedure to lower blood sugar~     levels to see how the body recovers after each treatment.~   "
137353|NCT01769391|"~     The main purpose of this study is to evaluate if necitumumab added to standard chemotherapy~     of paclitaxel and carboplatin is more effective to treat cancer than the standard~     chemotherapy of paclitaxel and carboplatin alone.~   "
137354|NCT01769378|"~     The purpose of this study is to assess the efficacy and safety of once-weekly dulaglutide~     compared to placebo in participants with type 2 diabetes who have inadequate glycemic control~     with sulfonylurea monotherapy.~   "
137355|NCT01769365|"~     To simultaneously compare the efficacies of 7-day triple, 10-day sequential and 7-day~     quadruple therapies for H. pylori infection in Taiwan. Consecutive H. pylori-infected~     patients were randomly assigned to a 7-day standard triple therapy (pantoprazole,~     clarithromycin, and amoxicillin for 7 days), a 10-day sequential therapy (pantoprazole and~     amoxicillin for 5 days, followed by pantoprazole, clarithromycin and metronidazole for a~     further 5 days) or a 7-day quadruple therapy (pantoprazole, clarithromycin, amoxicillin and~     metronidazole for 7 days). The end point is to evaluate the effectiveness of Helicobacter~     pylori eradication rates between three groups.~   "
137356|NCT01769352|"~     The purpose of this study is to compare the change in visual acuity of patients with post~     surgical cystoid macular edema who will be treated with two different regimens.~   "
137357|NCT01769339|"~     The purpose of this study is to evaluate the efficacy and safety of miconazole plus~     hydrocortisone cream in the treatment of participants with vulvar candidiasis (yeast~     infection of the vulva).~   "
137358|NCT01769326|"~     The purpose of this research study is to compare different methods for training hand movement~     at home after stroke. This study involves research because it will test two experimental~     devices, the MusicGlove and the Resonating Arm Exerciser (RAE), compared to conventional hand~     and arm exercises. The MusicGlove is a glove that measures finger movements and allows its~     user to play a musical computer game using those movements. The RAE is a lever that attaches~     to a manual wheelchair with elastic bands and can be pushed back and forth to exercise the~     arm.~   "
137359|NCT01769313|"~     This clinical study (non AMG/non MPG) is a contralateral, comparative, randomized,~     prospective, single-center, multi-surgeon, investigator masked study to investigate whether~     the femtolaser cataract surgery causes any significant differences in the resulting Intra~     Ocular Lens overlap (ΔROverlap) as compared to the conventional, manual continuous~     curvilinear capsulorhexis (CCC). The Intra Ocular Lens overlap (ΔROverlap) is defined as the~     difference between the Intra Ocular Lens center of mass to the capsulotomy aperture center of~     mass.~   "
137360|NCT01769300|"~     The specific aim of this cluster-randomized (site) comparative effectiveness research study~     is to determine whether children who are (1) 5-12 years of age, (2) cared for in ePROS~     practices or clinics using an electronic health record (EHR), (3) have attention-deficit~     hyperactivity disorder (ADHD), and (4) are to receive treatment with stimulant medication for~     the first time in these practices, have superior clinical outcomes if their clinicians have~     access to an EHR-guided clinical decision support system (intervention group) than if their~     clinicians have no such access (control group).~   "
137361|NCT01769287|"~     The purpose of this study is to check if at 1 year after surgical ablation the electrical~     impulses that cause atrial fibrillation (AF) are still blocked from being able to get into~     the heart.~      Hypothesis Conduction block and ganglionic destruction are required for freedom from AF.~   "
137362|NCT01769274|"~     The purpose of this study is to evaluate the efficacy and safety of single doses of~     PF-05089771 against placebo in treatment of pain in patients with primary, inherited~     erythromelalgia.~   "
137363|NCT01769261|"~     Evolution of patient's health after hospital discharge is poorly documented. The~     investigators hypothesize that information of good quality on this concern might be~     accessible at a relatively low cost from patients, further referred to as sentinel patients,~     who would voluntary report their health evolution on a dedicated web site.~      The SENTIPAT study presents as a proof of concept study. It will collect patient's health~     evolution during a post-hospital discharge period of 45 days. The study presents as a~     randomized trial comparing patients' reports issued from two different methods in a patient~     population returning home after hospital discharge and having at disposal an internet access~     at home:~      in the  internet  arm, sentinel patients will be solicited to directly report their~     post-discharge health evolution on a website especially devoted for collecting these data~     while in the  telephone  arm, the same items will be collected through a telephone~     interview 45 days after hospital discharge. Investigations will focus on post-discharge~     adverse events and will include appearance/worsening of symptoms, healthcare resources~     utilization, quality of life, and patients' satisfaction.~   "
137364|NCT01769248|"~     Endoscopic ultrasound (EUS) is paramount in the diagnosis and evaluation of cancers involving~     the gastrointestinal tract. EUS allows for the acquisition of cellular (fine needle aspirate~     - FNA) or tissue biopsy (fine needle biopsy - FNB) for diagnostic purposes. This has~     traditionally been done with fine needle aspirate where a needle is inserted into the tumor~     and potentially malignant cells are extracted for microscopic analysis. More recently, a~     needle that allows a tissue biopsy for histologic analysis has been FDA approved.~      The Echotip Procore (Cook Medical) core biopsy needle (ETP), has been demonstrated to provide~     excellent efficacy for core biopsy samples. Final diagnostic yield using this needle ranges~     from 80-90% and appears to be significantly greater than EUS-FNA for lesions requiring~     histology for diagnosis. However, there is currently only limited data from prospective~     studies comparing EUS-FNA to EUS-FNB with the ETP needle. The investigators propose a~     randomized, prospective, cross-over study comparing diagnostic accuracy of EUS-FNA to~     EUS-FNB.~   "
137365|NCT01769235|"~     The objective of this study is to compare the safety and efficacy profiles of Taro~     Pharmaceutical Inc.'s Clindamycin Phosphate and Benzoyl Peroxide Gel 1.2%/2.5% to Acanya®~     (Clindamycin Phosphate and Benzoyl Peroxide) Gel, 1.2%/2.5% and to demonstrate the superior~     efficacy of the two active formulations over that of the vehicle in the treatment of acne~     vulgaris.~   "
137366|NCT01769222|"~     This pilot phase I/II trial studies the side effects and best of dose ipilimumab when given~     together with local radiation therapy and to see how well it works in treating patients with~     recurrent melanoma, non-Hodgkin lymphoma, colon, or rectal cancer. Monoclonal antibodies,~     such as ipilimumab, can block cancer growth in different ways. Some block the ability of~     cancer cells to grow and spread. Others find cancer cells and help kill them or carry~     cancer-killing substances to them. Radiation therapy uses high energy x rays to kill cancer~     cells. Giving monoclonal antibody therapy together with radiation therapy may be an effective~     treatment for melanoma, non-Hodgkin lymphoma, colon, or rectal cancer~   "
137367|NCT01769209|"~     This phase II trial studies how well giving bortezomib together with combination chemotherapy~     works in treating patients with relapsed or refractory acute lymphoblastic leukemia.~     Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for~     cell growth.~   "
137368|NCT01769196|"~     The primary objectives of this study are to determine the effect of simtuzumab (GS-6624) on~     progression-free survival (PFS) as determined by either a categorical decline in forced vital~     capacity (FVC) or all-cause mortality, in all participants enrolled or in a subset of~     participants who are classified as lysyl oxidase-like-2 (LOXL2) high based on a prespecified~     level in serum at baseline.~   "
137369|NCT01769183|"~     The purpose of this study is to determine the efficacy in the use of topical Squalamine~     Lactate Ophthalmic Solution, 0.2% in the treatment of retinal neovascularization resulting~     from proliferative diabetic retinopathy.~   "
137370|NCT01769170|"~     The purpose of this study is to compare the effectiveness of CMX001 to placebo for the~     prevention of CMV infection in stem cell transplant patient who do not have CMV before~     starting treatment with CMX001.~   "
137371|NCT01769157|"~     L-carnitine and thyroid hormone tended to antagonize reciprocally in human body. Urinary~     excretion of L-carnitine decreased in hypothyroid patients, and levothyroxine supplementation~     increased excretion of L-carnitine. The investigators hypothesized that supplying L-carnitine~     to hypothyroid patients with fatigue symptom could improve the quality of life, and fatigue~     score in them. Therefore, the investigators planned to compare the efficacy of L-carnitine~     and placebo in hypothyroid patients who had taken levothyroxine.~   "
137372|NCT01769144|"~     This study aims to compare the effectiveness of two wound dressings, Acticoat Absorbent (AA)~     and BCT Antimicrobial (BCT) on Split Thickness Skin Graft (STSG) donor site.~   "
137373|NCT01769131|"~     An Allis clamp causes less pain and bleeding than a single tooth tenaculum when used for~     mobilization of the cervix during common gynecologic office procedures.~      The primary object is to determine the presence of a difference in pain perception between~     the two instruments.~      The secondary objective is to evaluate the differences in the frequency of bleeding, that~     requires treatment, after removal of the instrument and the need to use an alternative~     instruments.~   "
137374|NCT01769118|"~     Caffeine has a stimulatory effect on the ANS. This has not yet been investigated in preterm~     infant who get caffeine before stopping ventilation. The investigators hypothesis is that~     this stimulatory effect may be characterized by HRV analysis methods.~   "
137375|NCT01769105|"~     Recently, beneficial effects on Meibomian gland dysfunction (MGD) of a single automated~     thermal pulsation with the Lipiflow® system have been reported in several case reports. In~     one study this treatment was compared with hyperthermia (iheat®) for 4 weeks. However,~     treatment recommendations for lid hygiene according to the MGD-report consist of hyperthermia~     followed by lid massage and lid margin cleansing over several months. To the best of the~     investigators knowledge this is the first randomized prospective study to compare automated~     thermal pulsation treatment with the new Lipiflow ® system with a standard lid hygiene~     regime.~      The investigators suggest that a single treatment with Lipiflow® is superior to a lid hygiene~     regime.~   "
137376|NCT01769092|"~     For many years, there has been interest in the question of whether a special diet of some~     sort could be used to help control epileptic seizures. The ketogenic diet has been used since~     the 1920s, but it is used only in children, and is nutritionally unbalanced. It is typically~     withdrawn after 3 years. The ketogenic diet unfortunately, offers no long-term solution to~     seizure control.~      Our preliminary research now suggests that there may be a healthy, long-term dietary approach~     to controlling seizures.~      Based on our animal work and published clinical studies the investigators hypothesize that a~     DHA dose of 3 g/day will reduce seizure frequency in patients with intractable seizures.~   "
137377|NCT01769079|"~     Chronic treatment of stable angina with nitrates long and short action is extremely frequent.~     In clinical practice the most commonly observed is a combination of anti-anginal agents,~     usually including nitrates fixed in an attempt to improve the quality of life of patients,~     which is not always met with success.~      Numerous questions and problems are seen with chronic use of oral nitrates. From a practical~     standpoint, some advocate the withdrawal of medication in stable patients, while many~     physicians still hesitate to withdraw the medication by the lack of definitive information~     about its consequences. In this sense there is a rationale for the attempted removal of~     nitrate fixed these patients, although evidence to support this action have not been~     adequately evaluated.~   "
137378|NCT01769066|"~     The aim of this study is to explore the Clinical Value of Sequential Gefitinib With~     Pemetrexed/Platinum compare with Pemetrexed/Platinum for Advanced NSCLC.~   "
137379|NCT01769053|"~     In 2008 a new ventilation strategy termed variable Pressure Support ventilation (PSV) was~     introduced, which is able to increase the variability of the respiratory pattern independent~     from the inspiratory effort. In experimental lung injury, variable PSV was found to improve~     gas exchange and decrease the inspiratory effort, while reducing alveolar edema and~     inflammatory infiltration compared to conventional(non-variable) PSV. Importantly, variable~     PSV reduced peak airway pressure and respiratory system elastance in a variability dependent~     manner.In addition, preliminary observations suggest that variable PSV can reduce the work of~     breathing and improve patient comfort, but it is not known whether this new ventilatory~     strategy is able to speed the weaning from mechanical ventilation.~      Since variable PSV can reduce the mean pressure support, it may lead to a faster reduction of~     pressure support and, therefore, a shorter weaning period than conventional PSV.~      The hypothesis of this study is that variable pressure support ventilation reduces the~     duration of mechanical ventilation to non-variable (conventional) pressure support~     ventilation.~   "
137380|NCT01769040|"~     This investigational trial will be assessing the effect of rifaximin on pathophysiology and~     haemodynamics in the patient with liver cirrhosis, and addressing the effect of rifaximin on~     several organs on marker level. The molecular and physiological effects of rifaximin will be~     explored.~      The investigators hypothesize that intestinal decontamination with rifaximin in patients with~     cirrhosis and ascites will interrupt bacterial translocation from the gut, diminish the~     following inflammatory response, prevent splanchnic vasodilatation and portal systemic~     contraction and thereby reduce the risk clinical complications to cirrhosis.~      If rifaximin can correct small intestinal bacterial overgrowth and demonstrate improvement in~     liver haemodynamics, renal function and systemic dynamics, then these effects may contribute~     to the overall well-being of the patient and prevent complications to the underlying~     cirrhosis such as risk of infections, progression of disease, and admission to hospital.~   "
137381|NCT01769027|"~     An increasing body of evidence indicates that an immune basis might underline a number of~     pediatric neuropsychiatric disorders. Research studies found a subgroup of children who had~     Obsessive compulsive (OCD) and/or tic disorders following a Group A beta-hemolytic~     streptococcal (GAS) infection. The subgroup is identified by the acronym, PANDAS (pediatric~     autoimmune neuropsychiatric disorders associated with streptococcal infections. More~     recently, several PANDAS variants have been described, including adult-onset variant. There~     are many evidences that OCD/tic symptoms could be due to an immunologic reaction against~     brain tissues following a streptococcal infection.~      The purpose of this study is to know if sertraline (one of the SSRI approved by FDA to~     improve OCD/tic symptoms in these patients) plus antibiotic (benzathine penicillin G or~     azithromycin in case of penicillin allergy) is more effective than SSRI only.~      Patients who will not respond to antibiotic will be treated with intravenous immunoglobulin~     (IVIG) in order to inactivate the immune reaction versus brain tissues.(No treatment response~     is based on the lack of a Y-BOCS score improvement of at least 35%).~      Objectives:~        -  To determine the safety and efficacy of SSRI+AB compared to SSRI only.~        -  To test the safety and additional beneficial effects of high dose of IVIG on antibiotic~          prophylaxis for the treatment of OCD symptoms in non-responders patients with PANDAS.~      Study methodology:~        -  Participants will be screened to obtain medical history and other information at~          Neurologic and Psychiatric Sciences Department of Florence University Hospital and at~          Paris-est University.~        -  Participants will receive a treatment of either SSRI+AB or SSRI+placebo for 12 weeks~          (double-blind randomized trial)~        -  Patients who will not respond to AB will be admitted to the hospital to receive IVIG for~          5 days, for 5 consecutive months.~        -  Follow-up visits will take place 3 and 6 months after the first evaluation, followed by~          6 months follow-ups for 3 additional years.~      Blood samples (including blood cytokine determination), ECG, Doppler and 2-dimensional~     echocardiogram EEG, imaging studies (2 tesla MRI), and other tests will be performed both~     before and after the treatment with SSRI+AB or SSRI+placebo and in case also after IVIG~     treatment.~   "
137382|NCT01769014|"~     It is the goal of this study adherence and quality of life in a population of people~     suffering from schizophrenia or schizoaffective disorder and to analyze if these factors are~     influenced by treatment, support, social services, and residential treatment. The study~     population is drawn from the the cantons Glarus and Graubunden as well as Liechtenstein.~   "
137383|NCT01769001|"~     Patients will be enrolled into one of three PRX-102 dosing groups (0.2 mg/kg, 1.0 mg/kg, 2.0~     mg/kg), to receive the same dose they had received in Phase 1/2 study PB-102-F01, and will~     continue to receive PRX-102 as an intravenous infusion every 2 weeks for 38 weeks.~   "
137384|NCT01768988|"~     This is a randomized, double blind controlled, parallel arms trial, aimed to assess the~     efficacy of pregabalin on pancreatic cancer induced abdominal pain. The goals of this study~     include (1) assessing the analgesic effect of pregabalin in comparison to placebo; assessing~     the presence of central sensitization and its potential reversion by Pregabalin; (3)~     assessing quality of life of patients treated with pregabalin in comparison to placebo; (4)~     to compare adverse effects in patients treated with Pregabalin in comparison to placebo; (5)~     to compare anxiety and depression in patients treated with pregabalin in comparison to~     placebo.~   "
137385|NCT01768975|"~     The purpose of this trial is to investigate the efficacy and safety of OLT1177 Gel in~     subjects with moderate to severe pain associated with osteoarthritis of the knee following~     cessation of pain therapy.~   "
137386|NCT01768962|"~     To compare local and systemic pharmacokinetics of tenofovir reduced-glycerin 1% gel after 2~     weeks of daily rectal use and after 2 weeks of daily vaginal use~   "
137387|NCT01768949|"~     The purpose of the study RVSTAR is to evaluate whether echocardiographic criteria exploring~     the right ventricle can predict the inefficacy and/or the unsafeness of recruitment maneuvers~     in patients suffering from acute respiratory distress syndrome~   "
137388|NCT01768936|"~     Procalcitonin (PCT) serum levels are monitored in patients with secondary peritonitis after~     initial operative focus elimination to investigate the PCT ratio's impact on decision-making~     for or against early relaparotomy in the on-demand relaparotomy concept of secondary septic~     peritonitis.~   "
137389|NCT01768923|"~     To investigate the effect of two tight-control treatment strategies, aiming at 1) 2011~     American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) definition of~     remission compare with 2) minimal disease activity (Disease Activity Index in 28 joints~     [DAS28] <2.6), on arterial stiffness in early rheumatoid arthritis (RA) patients.~      To compare the effect of two treatments on arterial stiffness in Early Rheumatoid Arthritis~   "
137390|NCT01768910|"~     The purpose of this study is to provide profound insight into the supraspinal neuronal~     mechanisms and networks responsible for lower urinary tract (LUT) control and to verify,~     amend or adjust neuronal circuitry models established from findings in healthy subjects in~     the context of neurogenic and non-neurogenic LUT dysfunction.~   "
137391|NCT01768897|"~     This phase I trial studies the side effects and best dose of CPI-613 when given together with~     cytarabine and mitoxantrone hydrochloride in treating patients with relapsed or refractory~     acute myeloid leukemia. Drugs used in chemotherapy, such as CPI-613, cytarabine and~     mitoxantrone hydrochloride, work in different ways to stop the growth of cancer cells, either~     by killing the cells or by stopping them from dividing. CPI-613 may help cytarabine and~     mitoxantrone hydrochloride work better by making cancer cells more sensitive to the drugs~   "
137392|NCT01768884|"~     Prospective, Double Blind, Randomized Single-Center, Evaluation of Safety and Tolerability of~     Nitric Oxide Given Intermittently via Inhalation to Subjects with Bronchiolitis-Phase IIa~     Bronchiolitis is defined as an infection of the small airways. It is also the most common~     manifestation of acute lower respiratory infection (ALRI) in early infancy, and is the~     leading cause of global child mortality. NO has been shown to play a critical role in various~     biological functions, including the vasodilatation of smooth muscle, neurotransmission,~     regulation of wound healing and immune responses to infection such as microbicidal action~     directed toward various organisms. NO in the airways is considered to play a key role in the~     innate immune system in which the first-line of host defense against microbes is built.~      It has shown the beneficial effect of NO in different diseases with several options of doses~     and regimens - from newborn with primary pulmonary hypertension which showed improvement in~     oxygenation after 30 minutes of NO treatment at 10-20 ppm, to a subject with adult~     respiratory distress syndrome, who demonstrated clinical improvement during NO treatment at~     18 and 36 ppm.~      In vitro studies utilizing a variety of nitric oxide (NO) donors suggested that NO, in part~     per million (ppm) concentrations, possesses antimicrobial and anti-viral activity against a~     wide variety of phyla including bacteria, viruses, helminthes and parasites.~      Primary Objectives: Assess the safety of NO intermittent inhalation treatment in 2-12 month~     old bronchiolitis subjects. Assess the tolerability of NO intermittent inhalation treatment~     in 2-12 month old bronchiolitis subjects Secondary Objective: Assess the efficacy of NO~     intermittent inhalation treatment compared to standard treatment in 2-12 months old~     bronchiolitis subjects.~      Prospective, double blind, randomized single-Center study of 44 hospitalized subjects aged 2~     -12 months old, diagnosed with bronchiolitis will be enrolled into the study and randomized~     into 2 groups. Group 1 -Treatment group - Will receive nitric oxide inhalation in addition to~     standard treatment for up to 5 days, Group 2 - will receive ongoing inhalation of the~     standard treatment for 5 days.~      Treatment administration: Treatment blindness will be kept by separating between unblinded~     team members (giving the actual treatment) and blinded team members, and by hiding the NO~     container and all study related equipment behind a curtain. Between study inhalations the~     subject will continue to receive the standard inhalation treatment. Oxygen (O2), NO ,~     nitrogen dioxide(NO2)and fraction of inspired oxygen (FiO2) delivered to the patient will be~     continuously monitored.~      All subjects will come for follow up visits on day 7(+5), 14 (+5) days and will be contacted~     on day 30 (+5) from day of admission to the department.~      End of study treatment (both groups) will be assessed by a blinded study physician base on~     clinical assessment. Subject improvement that will lead to end study treatment = clinical~     score < 6 and/or (Oxygen saturation)SaO2 above 92% and/or decision of subject discharge from~     the hospital.~   "
137393|NCT01768871|"~     The primary objective of this study is to evaluate the function of the knee after a total~     knee replacement with the VEGA system®.~   "
137394|NCT01768858|"~     The main purpose of this study is to assess patients` adherence attitudes (beliefs) to the~     maintenance therapy with a scheduled Adalimumab monotherapy or a combination therapy with~     methotrexate and to investigate whether there are correlations between such beliefs and~     adherence to maintenance treatment.~   "
137405|NCT01768715|"~     Patients with alcoholic hepatitis non-responsive to steroids have a poor prognosis. Recently~     a French-Belgian prospective study has obtained good results (acceptable survival with a low~     rate of alcohol recidivism).~      The hypothesis of the present study is that carefully selected Spanish patients with~     alcoholic hepatitis that do not respond to steroid therapy may have a good survival if they~     receive a liver transplant. The expected rate of alcohol recidivism in such a selected~     population will be low.~   "
137406|NCT01768702|"~     Evaluation the safety and efficacy of C3BS-CQR-1 by comparing the overall response to~     standard of care and C3BS-CQR-1 relative to standard of care and a sham procedure.~   "
137457|NCT01768039|"~     Two hundred and forty patients with multiple sclerosis who met the study criteria will be~     enrolled in this randomized double blind placebo-controlled clinical trial.~      They will randomly assigned to placebo or vitamin D treatment group. The total time of study~     is 52 weeks and the vitamin D group will be treated by weekly 50000 International unit(IU)~     vitamin D, while the other group will receive weekly placebo. The annual relapse rate and~     EDSS will be compared at baseline, month 6 and 12.~   "
137395|NCT01768845|"~     Hematopoietic progenitor cell (HPC- primitive cells in the blood, bone marrow and umbilical~     cord that can restore the bone marrow) transplant can be a curative therapy for the treatment~     of hematologic malignancies (a disease of the bone marrow and lymph nodes). The source of~     cells used for the transplant comes from related (sibling) and in cases where there is no~     sibling match, from unrelated donors through the National Marrow Donor Program. The~     availability of a suitable donor can be a significant obstacle for patients who need a~     transplant but do not have a matched donor. Cord blood that has been harvested from an~     umbilical cord shortly after birth has a rich supply of cells needed for transplant. These~     stored cord bloods are now being used to transplant adults without a matched donor~      Advantages to using cord blood includes a readily available source of cells with no risk to~     the donor during the collection process, immediate source of cells in urgent situations (no~     lengthy donor work-up)and a reduction in infectious disease transmission to the recipient.~      One of the main disadvantages is the cord blood has a small number of cells needed for~     transplant. In an adult, usually two cords are needed and large recipients do not qualify~     because they need too many cells.~      This study will use two different preparative regimens (chemotherapy and radiation) followed~     by one or two umbilical cord units (UBC). The preparative regimen used will be chosen by the~     physician and is based on patient's age, disease and medical condition at the time of~     transplant.~      Multiple objectives for this study include disease-free and overall survival, treatment~     related mortality, rate of cells taking hold, and the incidence and severity of the~     transplant complication called graft versus host disease (GVHD).~   "
137396|NCT01768832|"~     Parkinson disease (PD) is characterized by substantial disability and reduced quality of~     life, both of which can be attributed in large part to difficulties with walking. Evidence~     suggests that exercise may be an important addition to traditional treatments, particularly~     with respect to addressing walking problems. In particular, dance and treadmill training have~     been individually shown to improve walking performance and quality of life. At present it is~     not clear whether dance or treadmill training have similar effects or if one is superior to~     the other. Furthermore, our understanding of the means by which these exercise interventions~     convey benefits is extremely limited. This study aims to address these knowledge gaps by~     directly comparing dance, treadmill training and stretching (control group). The primary area~     of interest is the effects on gait, with secondary measures of disease severity, balance, and~     quality of life. The investigators will determine not only the effects of the interventions~     on walking performance, but will also investigate the effects of the interventions on~     connections between different parts of the brain and on brain function during imagined~     walking tasks using functional magnetic resonance imaging (fMRI). Participants will be~     randomly assigned to dance, treadmill training, or a stretching/flexibility control group.~     Participants will be assessed over a period of 6 months at 3 different time points. The~     investigators hypothesize that both dance and treadmill training will lead to improvements in~     forward walking, but that dance will result in greater improvements in backward walking~     compared to treadmill training. Furthermore, the investigators hypothesize that the tango and~     treadmill interventions will have different effects of brain function and brain connections.~     The investigators expect dance to enhance the activity and connections of particular brain~     regions and treadmill training to enhance activity and connections of different brain~     regions. The investigators do not expect changes in brain activity or connections in the~     control group.~   "
137397|NCT01768819|"~     Although some authors have observed favorable effects of group physical activity programs,~     others have reported that the individualized prescription of exercises may be jeopardized by~     programs that do not allow sufficient consideration of individual characteristics. Therefore,~     we aim to verify the effects of an elderly-specific multimodal physical activity program on~     physical parameters after one year of intervention.~   "
137398|NCT01768806|"~     This study is a large, multi-site, randomized controlled NIH trial that evaluates whether The~     P.L.A.Y. (Play and Language for Autistic Youngsters) Project is effective. The PLAY Project~     Home Consultation model coaches parents, through monthly home visits and the use of video~     feedback, to effectively interact with their young child with autism. The aims of the study~     are 1.) to show that the PLAY Home Consultants show fidelity to the model, 2.) that~     caregivers can be taught to interact in an engaging way with their child (with causing more~     stress), 3.) that the child then interacts better, improves his/her language, and has reduced~     severity of his or her autism.~   "
137399|NCT01768793|"~     This project will test a novel lifestyle intervention to help overweight and obese~     socioeconomically disadvantaged African American women achieve healthy weight control during~     and after pregnancy and improve the health of their offspring. The treatment will be given~     through an existing national home visiting program, Parents As Teachers (PAT), which will~     facilitate sustainability and nationwide dissemination, if effective. We hypothesize that~     compared with standard PAT monitoring and counseling (PAT), women randomized to the lifestyle~     intervention program (PAT+) will have a lower percentage who exceed Institute of Medicine~     recommendations for gestational weight gain.~   "
137400|NCT01768780|"~     Various methods are used to assess the level of anesthesia block after spinal anesthesia.~     Among them, ice cubes, alcohol swabs, and needles are commonly used in the clinical setting,~     but ice is limited by difficulties with management and transportation, and needle assessment~     has problems owing to the risk of pain, infection, and injury to the patient.~      Hence, the alcohol swab is commonly used in practice. However, the absence of pain is more~     important in the surgical process, and assessing the pain block level is more feasible in~     practice than assessing the sensory nerve block level using the alcohol swab.~      Therefore, it seems to be better to use the peripheral nerve stimulator for the accurate~     assessment of the pain block level. This has the advantage of continuous measurement of the~     block level, which can be used in a practical manner in conjunction with the surgical~     incision.~      Hence, the author compared the conventional method using the alcohol swab with the use of the~     peripheral nerve stimulator to determine which method is more practical in the measurement of~     spinal anesthesia block level.~   "
137401|NCT01768767|"~     This study is looking at the safety and efficacy of combined ketamine and lithium therapy for~     treating patients with bipolar depression who are taking a mood stabilizer that is not~     working for them.~   "
137402|NCT01768754|"~     A growing body of evidence suggests that in individuals with chronic lung disease their walk~     speed is related to their daily function and quality of life. It is possible to assess their~     usual (routine) and fast walking speeds by getting them to walk in a flat hallway.~      In individuals with chronic lung disease, we anticipate that their usual walk speed will be~     helpful in exercise prescription and use in multidimensional scoring systems. However, it is~     important to first determine the measurement properties of these two walk speeds.~   "
137403|NCT01768741|"~     The purpose of this study is to investigate the clinical value of laparoscopic liver~     resection in the treatment of hepatocellular carcinoma by assessing its Surgical and~     oncologic outcomes comparing with open liver resection.~   "
137404|NCT01768728|"~     The purpose of this study is to investigate the influence of the laparoscopic and open left~     hemihepatectomy on acute surgical trauma and stress response.~   "
137407|NCT01768689|"~     Adherence to tyrosine kinase inhibitors is associated with improved outcomes in chronic~     myeloid leukemia patients. Hence, improved adherence might improve CML patients' prognosis.~      Decreased adherence is a common problem in such patients, with non-adherence in up to 30% of~     patients in several studies. Recently, an emphasis has been placed on improving patient's~     adherence to tyrosine kinase inhibitors in these patients. However, there is no prospective~     high-quality evidence showing that adherence can be improved in these patients.~      Therefore, the investigators hypothesize that adherence-encouraging interventions improve~     adherence to tyrosine kinase inhibitors in chronic myeloid leukemia patients.~   "
137408|NCT01768676|"~     The purpose of this study is to determine whether avanafil will affect different aspects of~     sperm production.~   "
137409|NCT01768663|"~     The purpose of this study is to examine the drug-drug interaction effects of ciprofloxacin,~     itraconazole, and rifampin on the pharmacokinetics of lumacaftor in combination with~     ivacaftor as well as to evaluate the potential effects of lumacaftor in combination with~     ivacaftor on lung function.~   "
137410|NCT01768650|"~     This study seeks to compare two different behavioral treatments for pain in Veterans with a~     history of TBI. Both treatments involve educating the Veteran about pain, discussing the~     impact of pain, and different ways to manage it in hopes of decreasing pain and its impact on~     life. These approaches are called self-management approaches to pain. Both of these~     treatments are commonly used in pain clinics to treat pain in persons with back pain,~     headaches, and other types of chronic pain. The investigators will be delivering both~     treatments over the telephone to make the treatments accessible to Veterans wherever they~     live.~   "
137411|NCT01768637|"~     Higher coronary in-stent thromboses and bleeding complications on anti-platelet agents are~     more common in Chronic Kidney Disease vs. non-Chronic Kidney Disease patients. Poor~     inhibition of platelet aggregation by anti-platelet agents predicts future cardiovascular~     events. Clinical practice guidelines are ambiguous about the use of these agents in Chronic~     Kidney Disease due to lack of controlled studies. The investigators hypothesize that patients~     with Chronic Kidney Disease compared with non-Chronic Kidney Disease have reduced platelet~     aggregation and poor platelet inhibitory response to aspirin. The aims are to 1) define the~     range of whole blood platelet aggregation in stages 3-5 Chronic Kidney Disease patients; 2)~     investigate whether patients with stages 4-5 Chronic Kidney Disease vs. non-Chronic Kidney~     Disease have lower platelet aggregation or impaired von Willebrand Factor activity; and 3)~     compare inhibition of platelet aggregation from baseline after 2 weeks of aspirin therapy and~     another 2 weeks of clopidogrel therapy added to aspirin in Chronic Kidney Disease vs.~     non-Chronic Kidney Disease patients. Accomplishing these aims will provide pilot data to~     power future studies of targeted anti-platelet agent treatments in Chronic Kidney Disease in~     order to improve cardiovascular outcomes.~   "
137412|NCT01768624|"~     The primary aims of the Patient INformation about Options for Treatment (PINOT) Follow-up~     Study are to determine the proportions of patients, identified in the 2009 PINOT cohort that:~      (i)Made the transition to home dialysis, after an initial start on center-based dialysis.~      (ii)Commenced dialysis, or a time-limited trial of dialysis within 3 years, after confirmed~     plans for conservative care.~      The hypotheses to be tested in the PINOT follow-up study are:~        1. 50% of stage 5 chronic kidney disease patients who plan for home dialysis do not~          commence home dialysis within 3 years, and instead remain on centre-based haemodialysis;~          and,~        2. less than 15% of stage 5 chronic kidney disease patients who plan for conservative care~          commence dialysis within 3 years.~   "
137413|NCT01768611|"~     Cells damaged by hyperglycemia are unable to downregulate glucose entrance in presence of~     high extracellular glucose resulting in intracellular activation of deleterious biochemical~     pathways. Expression of GLUT-1, the major glucose transporter in mesangial cells, is~     increased and participates in the induction of diabetic nephropathy. Variants in the gene~     encoding GLUT-1 (SLC2A1) have been associated to this diabetic complication. The aim of this~     study was to test whether polymorphisms in SLC2A1 confer susceptibility to diabetic~     nephropathy in Brazilian type 1 diabetes patients.~   "
137414|NCT01768598|"~     Boys suffer a disproportionately large number of fractures compared to girls (55-60%). This~     study aims to determine why this is the case by identifying risk factors for wrist fractures.~     The increase in fracture during childhood and adolescence may be associated with 1)~     risk-taking behaviour in boys, 2) obesity trends in boys during childhood and adolescence,~     and/or 3) impaired acquisition of bone strength during childhood and adolescence. Importantly~     from a knowledge translation perspective, modifiable factors such as behaviour, dietary~     habits or physical activity in boys may predict fracture.~      The investigators will measure 400 children (100 girls and 100 boys who have sustained a~     fracture; 100 same age and sex friends) across 4 years of growth. This study will assess risk~     behaviours, diet, physical activity, motor proficiency (i.e., balance and coordination), fat~     and muscle mass and bone strength to determine if there are, 1) differences in whether all or~     some of these factors predict fractures in boys compared with girls and, 2) whether these~     factors track forward similarly in boys compared with girls as children advance through the~     growth spurt.~   "
137415|NCT01768585|"~     This study investigates whether chronic heart rate reduction with ivabradine (Procoralan®,~     Servier, France) affects aortic compliance and endothelial function in patients with chronic~     stable coronary artery disease.~   "
137416|NCT01768572|"~     Primary Objective:~      To assess, in the same study, the safety of sarilumab and tocilizumab in participants with~     rheumatoid arthritis (RA) who were inadequate responders to or intolerant of tumor necrosis~     factor (TNF) antagonists.~   "
137417|NCT01768559|"~     Primary Objective:~      - To compare lixisenatide versus insulin glulisine in terms of glycosylated hemoglobin~     (HbA1c) reduction and body weight change at Week 26 in type 2 diabetic participants not~     adequately controlled on insulin glargine ± metformin.~      Secondary Objectives:~      - To compare the treatments/regimens on:~        -  The percentage of participants reaching the target of HbA1c <7% or ≤6.5%,~        -  Body weight,~        -  Self-Monitored Glucose profiles,~        -  Fasting Plasma Glucose (FPG),~        -  Post-prandial plasma glucose (PPG) /glucose excursions during a standardized meal test~          (subset of participants),~        -  Daily doses of insulins,~        -  Safety and tolerability.~   "
140061|NCT01734083|"~     The whole body vibration exercise group will have significantly more improvement in mobility,~     muscle strength, balance, balance confidence, and cognitive function with a lower fall rate~     than the control group.~   "
137418|NCT01768546|"~     Over the past 40 years, diabetes has increased dramatically in parallel with rapid increases~     in obesity.About 90 to 95% of persons with diabetes have type 2 diabetes, which begins when~     the body becomes resistant to the hormone insulin. Insulin resistance results from weight~     gain and physical inactivity, making the vast majority of new cases of type 2 diabetes~     preventable with lifestyle changes.~      After the findings of the Diabetes Prevention Program were released in 2002, the high cost of~     the lifestyle program prevented it from becoming widely adopted throughout the U.S.~      The UnitedHealth Center for Health Reform and Modernization (CHRM) will evaluate the use and~     effectiveness of a scalable approach for providing lifestyle-based diabetes prevention~     intervention through Comcast's XFINITY Video-On-Demand (VOD) programming, with additional~     non-compulsory support from SparkPeopleTM (Cincinnati, Ohio), an interactive tracking and~     problem solving web portal. By design, this effort will engage adult television viewers and~     offer them education and resources to support their efforts to achieve levels of weight loss~     and physical activity which have previously shown to prevent the development of type 2~     diabetes. Specifically, we aim to evaluate:~        1. Viewing patterns and characteristics of consumers accessing a prevention program via VOD~        2. Effectiveness in terms of weight loss achieved~        3. Consumers' ratings of overall content~   "
137419|NCT01768533|"~     The goal of this study is to do formative research which will lead ultimately to the~     development of a computer-based system called Tailored Information for Diet and Exercise or~     TIDE for short. TIDE will target energy balance behaviors to prevent the onset of obesity in~     children. The system will be used by physicians and parents/primary care givers in pediatric~     primary care practices with the aim of improving parent-pediatrician interactions related to~     counseling and anticipatory guidance on energy balance behaviors. The aim of this study is to~     develop a one-two page, paper-pencil proxy questionnaire that is used to query the parent of~     the child in the waiting room and assesses topic areas related to energy balance behaviors~     (EBB). The questionnaire will be referred to as the energy balance behaviors questionnaire~     (EBB-Q). This will require focus groups, cognitive testing of the questionnaire, and survey~     administration.~   "
137420|NCT01768520|"~     This clinical trial is planned to prove Entelon tab. arm is not inferior to Celebrex cap. arm~     in terms of the efficacy and safety through the change of K-WOMAC's total score sum in~     patients with osteoarthritis of knee.~   "
137421|NCT01768507|"~     Heme oxygenase 1 (HO-1) serves as a protective gene. The aim of this clinical trial is to~     evaluate the HO-1 stimulation of resveratrol in healthy humans.~   "
137422|NCT01768494|"~     Patients presenting to the emergency department (ED) currently face inacceptable delays in~     initial treatment, and long and costly hospital stays due to suboptimal initial triage.~     Accurate ED triage should focus not only on initial treatment priority, but also on~     prediction of medical risk and nursing needs to improve site of care decision and to simplify~     early discharge management. Herein, we propose a large prospective cohort study to optimize~     initial patient triage for (a) better determination of initial treatment priority, (b)~     overall risk and need for inhospital treatment and (c) early assessment of post-acute nursing~     needs.~   "
137423|NCT01768481|"~     Randomized controlled trial of statin intervention in dyslipidemic obese teenagers. Primary~     outcome is intima media thickness before and after intervention.~   "
137424|NCT01768468|"~     This is a randomized, double-blind study to compare the efficacy and safety of LAYLA tablet~     and Joins tablet in the treatment of osteoarthritis of the knee.~   "
137425|NCT01768455|"~     The objective of the study was to investigate the pharmacokinetic drug interaction between~     gemigliptin and glimepiride in healthy male subjects after oral administration concomitantly~     and each alone.~   "
137426|NCT01768442|"~     The investigators' goal is to incorporate advanced imaging information into the treatment~     planning process and assess response in tumor, nodes and non-cancerous tissues in head and~     neck cancer patients during and after concurrent chemotherapy and radiation therapy (chemoRT)~     via biophysical, biochemical and vascular imaging using magnetic resonance imaging (MRI). The~     investigators will recruit 30 patients with locally advanced head and neck cancer into the~     study. All patients will obtain an advanced MRI study at three time points: 1) before the~     start of chemoRT, 2) 4 weeks following the start of chemoRT, and 3) 3-4 months following~     completion of chemoRT. MRI scans will include a) T1, T2 and T2* imaging, b) vascular images~     using dynamic contrast enhanced (DCE) imaging, c) biophysical microstructure images using~     diffusion-weighted imaging, and d) biochemical images using MR spectroscopic imaging. The~     subject's response (tumor, nodes and salivary and mucosal tissues) will be evaluated using~     clinical outcomes. Correlations will be generated between the parameters obtained from MR~     images and from clinical response assessments.~      The purpose of this study is to assess whether advanced MR imaging techniques can be used to~     determine tumor and node response (i) four weeks following initiation of concurrent chemoRT~     and (ii) after completion of chemoRT in head and neck cancer, and to assess whether advanced~     MR imaging techniques can be used to predict early at-risk organ function (salivary gland and~     mucosal injury) as measured by salivary flow and oral mucositis to chemoradiation therapy (i)~     four weeks following initiation of concurrent chemoRT and (ii) after completion of chemoRT in~     head and neck cancer.~   "
137427|NCT01768429|"~     The aim of the project is to examine whether the sources of n-3 fatty acids and fish itself~     differ in their effects on glucose metabolism, lipid metabolism, blood pressure, and serum~     inflammatory markers. Lipidomic profiles and gene expression will be used for thorough~     assessment of the possible clinical changes. The study will compare the effects of~     alpha-linolenic acid containing vegetable oil, fatty fish, lean fish and control diet. The~     results of this project will help to identify the optimal source of n-3 fatty acids, and~     reveal the significance of the components of fish other than fatty acids. These data will be~     useful both nationally and internationally, since highly controlled dietary interventions~     utilizing new methodology are scarce.~   "
137428|NCT01768416|"~     The purpose of this study is to use the BIS monitor to assess the degree of consciousness in~     pre-terminal palliative patients admitted to our palliative care unit and to ascertain if~     this tool provides a more accurate assessment of consciousness in this specific group of~     patients than clinical observation of consciousness and the use of sedation scales.~      We hypothesize that the measured BIS results provide a more accurate assessment of the~     patient's level of consciousness than routine clinical observation or the use of sedation~     scales.~   "
137430|NCT01768390|"~     AIM: To evaluate the efficacy of daily tooth brushing with high concentrated fluoride~     dentifrice on white spot lesion (WSL) formation in adolescents during treatment with fixed~     orthodontic appliances (FOA).~      The null hypothesis is that neither incidence nor severity of lesions would differ from a~     control group using standard fluoride dentifrice.~      SUBJECTS AND METHODS: 420 healthy consecutive 11-16 year-old patients referred to 4~     Orthodontic Specialist Clinics are randomized to use either a dentifrice containing 5.000 ppm~     fluoride or a regular dentifrice with 1.450 ppm sodium fluoride. To be eligible for~     inclusion, the patients are scheduled for bimaxillary treatment with FOA for an expected~     duration of at least 1 year. All are instructed to use 0.25 gram dentifrice and brush their~     teeth during 2 minutes twice daily during the entire period of treatment. Before bonding, and~     after polishing with a rubber cup and non-fluoride pumice paste, 3 digital photos of the~     maxillary incisors, canines and premolars are taken. At debonding, remaining composite~     material on the surfaces is removed with a slow rotating carbide bur followed by polishing~     with a rubber cup and pumice paste. A new series of frontal and lateral digital photos is~     thereafter exposed.~      The primary outcome measure is the incidence and severity of WSL as registered separately by~     two blinded experienced and calibrated clinicians according to a validated index. A random~     sample of 50 cases is re-assessed to check intra- and inter-examiner reliability. The~     intervention is indended run throughout the full duration of the orthodontic treatment,~     varying between 18 and 24 months.~   "
137431|NCT01768377|"~     The purpose of this study is to compare intubation with nerve block with intubation with~     sedation in awake patients in terms of efficacy, ease, and the rate of complications and~     physician satisfaction~   "
137432|NCT01768364|"~     Is there anything to gain in giving antibiotics as prophylaxis when removing ureteric stents~     cystoscopically after stone surgery?~   "
137433|NCT01768351|"~     Current activated Vitamin D therapies are approved for treating secondary hyperparathyroidism~     in chronic kidney disease (CKD), and a large body of experimental data in animals confirms~     the effects of Vitamin D that extend beyond mineral metabolism. Several studies show that the~     benefits are greater with the newer vitamin D analog paricalcitol when compared with~     calcitriol. A large gap exists in our knowledge between epidemiological studies in human that~     demonstrate improved outcomes with vitamin D use and observations in preclinical studies~     demonstrating the pleiotropic effects of Vitamin D. To explore the provenance of~     epidemiological outcomes in CKD, we conducted a pilot randomized trial to determine whether~     the use of paricalcitol, compared to calcitriol, leads to improvement in anemia, a marker~     associated with worse outcomes in chronic kidney disease, and whether this effect not only~     reflects the hyperparathyroidism correction, but is also dependent on the direct effects of~     paricalcitol on erythroid progenitor cells.~   "
137434|NCT01768338|"~     The purpose of this study is to test the safety of rhIL-18 combined with ofatumumab to see~     what effects (good and bad) it has on subjects and their non-Hodgkin's lymphoma.~   "
137435|NCT01768325|"~     The purpose of this study is to evaluate a new EUS-guided biopsy needle (ProCore®) comparing~     it to conventional EUS-TCB needle (Quick-Core®) in the diagnosis of your suspicious disorder.~      This study needle (ProCore®) is a new EUS-guided biopsy needle and has been recently approved~     by the U.S. Food and Drug Administration (FDA) for use.~   "
137436|NCT01768312|"~     The purpose of this clinical Study is Tisporin Eye Drops 0.05%(Cyclosporine ophthalmic~     solution) group and Restasis Eye Drops 0.05%(Cyclosporine ophthalmic suspension) group 12~     weeks after treatment, each treatment group comparisons for evaluation of efficacy and safety~     in Moderate to Severe Dry Eye Disease.~      - Corneal staining test, Ocular surface disease index (OSDI), Tear break up time (TBUT),~     Non-anesthetic Schirmer test~   "
137437|NCT01768299|"~     A double-blind randomized controlled trial to compare a shorter interval between the~     administration of mifepristone and misoprostol (simultaneous administration compared to~     24hours from administration of mifepristone to receipt of the first dose of misoprostol) for~     termination of pregnancy up to 13-22 weeks of gestation. The investigators hypothesize that a~     shortened interval may achieve comparable efficacy in terminating pregnancy, whilst reducing~     the duration of the procedure and in turn, the duration of hospitalization.~   "
137438|NCT01768286|"~     This study is to evaluate the safety, tolerability, and antiviral efficacy of~     ledipasvir/sofosbuvir fixed dose combination (FDC) with or without ribavirin (RBV)~     administered for 12 or 24 weeks in treatment-experienced subjects with chronic genotype 1~     hepatitis C virus (HCV) infection.~   "
137439|NCT01768273|"~     The purpose of this study is to determine the safety and tolerability of PA-824 when given~     with a single dose of midazolam, and to determine whether PA-824 inhibits CYP3A to a~     clinically important degree as measured by the effect of PA-824 on the pharmacokinetics of~     midazolam, a known CYP3A substrate.~   "
137440|NCT01768260|"~     Enhanced External Counterpulsation(EECP) therapy may promote the recovery of visual function~     by improving the blood perfusion of eyes. The present study aims to investigate the effect of~     EECP on Anterior Ischemic Optic Neuropathy.~   "
137441|NCT01768247|"~     A thin endometrium is one of the most difficult problems encountered in assisted reproduction~     every day practice Regarding the proliferative phase, several ways of treatment have been~     undertaken to circumvent thin endometrium trying to increase thickness with questionable~     results.~      The objective of the current study will be whether a daily dose of 150 IU (international~     units) of human chorionic gonadotropin (HCG) for seven days concomitant with estrogen~     administration in estrogen replacement cycles can increase the endometrial thickness and~     improve pregnancy outcome.~   "
137456|NCT01768052|"~     The investigators plan to use optical brain imaging technology to observe patients with~     current major depression before, during, and after repetitive Transcranial Magnetic~     Stimulation (rTMS) clinical treatment. Clinical treatment involves 20-30 rTMS sessions over~     the course of 4-6 weeks.~      Our primary hypotheses are as follows:~        1. Primary Hypothesis: In patients with a positive response to rTMS, the investigators will~          observe an increase in the strength of connectivity as measured by fMRI among brain~          regions in the cognitive control network after 4 weeks of treatment.~        2. Secondary Hypothesis: Brain activation measured by functional Near-Infrared~          Spectroscopy(fNIRS) in the dorso-lateral prefrontal cortex (DLPFC) during rTMS will~          increase as the number of treatments increase. Detection of this increase in brain~          activity at the beginning of the treatment help researchers and physicians assess~          treatment response.~   "
137442|NCT01768234|"~     There is a large body of evidence from adult populations suggesting cognition in adults is~     affected by hydration status. The few studies conducted in the global North in populations of~     schoolchildren indicate that drinking water has an impact on pupil performance on basic~     cognitive tasks. No studies assessing the impact of dehydration and cognition in~     schoolchildren have been carried out in the global South, where access to water is the~     poorest and dehydration prevalence is likely higher. This study will examine the effect of~     drinking supplementary water during the school day on hydration status and on cognitive test~     scores in schoolchildren in Mali, West Africa.~      The investigators hypothesize that providing supplemental water will result in a decrease in~     prevalence of dehydration in the study group and will result in an improved performance on~     cognitive test scores.~      Data will be collected from up to four purposively-selected schools in the Sikasso region of~     Mali, from up to a total of 300 children. At each school pupils in grades 3-6 will be~     eligible for recruitment. Research staff will explain the study to pupils at the school and~     individually request informed oral assent for participation. A waiver of parental consent for~     pupil interviews will be secured from the Ministry of Education. At each school, school~     directors will be asked to sign in loco parentis (in the place of parent) on behalf of the~     pupil participants.~      Children that assent to participate in the study will be randomly allocated to the~     intervention or control group. Data collection will take place at each school over two days~     within a one-week period, with one study group tested on each of the two days. On the~     intervention testing day, all study participants will receive supplementary water. On the~     control testing day, no study participants will receive supplementary water. Testing~     procedures in both groups is identical and will include a five-minute interview, two~     cognitive testing sessions of 45 minutes each, and collection of two urine samples during the~     day. None of these activities collect personal data or identifiers, and the urine sample will~     not be stored.~      All data collection will occur at the school and will be conducted by trained local~     enumerators. There are no risks to participation other than a small amount of class time~     missed by pupils, and great efforts will be made to minimize time outside of class.~   "
137443|NCT01768221|"~     This one-arm pilot study will evaluate the feasibility and acceptability of Caregiver~     Outlook, a manualized chaplain-led intervention to improve the well-being of caregivers of~     seriously ill patients.~      Study Activities and Population Group:~      The investigators anticipate enrolling 36 informal caregivers (adults) through DUMC providers~     and/or self-referral. Potential subjects will be screened for study eligibility, consented if~     eligible and interested, and one week later administered a baseline survey by phone. Next,~     the chaplain-led intervention will be delivered by phone in three one-hour sessions, spanning~     a one month window. After session 3, subjects will receive a check-in phone call to briefly~     discuss their any additional thoughts, questions or concerns they may have. Sessions will be~     audio recorded. After intervention completion, follow-up surveys will be administered by~     phone at two points in time.~      Data Analysis and Risk/Safety Issues:~      This is a mixed-methods study involving qualitative thematic analysis and survey data,~     collected from the adult caregiver subjects. There are no known physical risks to~     participation, and the study team will work to ensure confidentiality and data~     safety/integrity.~   "
137444|NCT01768208|"~     This study is an open-label, cohort study to evaluate the potential mechanisms of Saxagliptin~     in the treatment of patients with type 2 diabetes (T2DM) using a comprehensive metabolomic~     method, in combination with fingerprint analysis and target analysis. It is a sub-study of~     STUDY: D168L00008.~   "
137445|NCT01768195|"~     The purpose of this study is to identify the effect of prophylactic entecavir in HBsAg~     Positive lymphoma patients treated with rituximab-based immunochemotherapy.~   "
137446|NCT01768182|"~     Objective: HIV infected individuals present a cluster of conditions that activate or injure~     the vascular endothelium. The administration of folates may exert beneficial effects on~     endothelial function in different populations at risk for cardiovascular disease. The aim of~     the study was to determine the effects of 4 weeks folinic acid supplementation on forearm~     vascular responses during reactive hyperemia in HIV-infected people under antiretroviral~     therapy.~      Methods: This was a prospective, randomized, double-blind, placebo-controlled trial to~     compare the effects of 4 weeks daily ingestion of 5 mg folinic acid (n=15) or placebo (n=15).~     Participants had to be on anti-retroviral therapy for at least 6 months before enrollment,~     with undetectable viral load, and CD4 cell count > 200 cells/mm3. Vascular function was~     evaluated with venous occlusion plethysmography at baseline and after 4 weeks, for the~     determination of brachial artery reactive hyperemia, and after isosorbide dinitrate~     administration~   "
137447|NCT01768169|"~     Increased understanding of the impact of long chain omega-3 PUFAs in combination with a low~     fat plant-based diet will contribute to decelerating further escalation of the epidemics of~     obesity, the (pre)metabolic syndrome, and T2DM in Taiwan.~   "
137448|NCT01768156|"~     HE4 is a new marker that could improve the detection of ovarian cancer. The HE4 assay may~     have an advantage over the CA-125 assay in that it is less frequently positive in patients~     with non malignant disease. Since the evaluation of HE4 for detection and diagnosis of~     ovarian cancer is well known, the behaviour of the marker during chemotherapy and follow-up~     period after treatment in metastatic ovarian cancer should be studied. It could be used in~     patient with non CA-125 secretary tumors. Prognosis and predictive value of HE4 should be~     compared with information provided by CA-125. The kinetics of HE4 values after treatment~     should be also analysed to determine the role that HE4 could play in the detection of~     recurrences during the follow-up of metastatic patients.~   "
137449|NCT01768143|"~     To measure competencies in propofol sedation for endoscopic procedures (NAPS)through~     development, test and validation of a reliable assessment tool in a simulator setting.~      Hypothesis: That the tool will demonstrate content and construct validity, ie. enable~     reliable measuring of necessary competencies of different levels in a reproducible way.~   "
137450|NCT01768130|"~     The study will investigate the test-retest variability of thermal thresholds in patients with~     persistent pain after open inguinal herniotomy. Sensory mapping with a cool metal roller~     delineated an area with cool sensory dysfunction on the painful site. In this area and in a~     contralateral area as a control, 5 sites were outlined, including the point of maximum pain.~     In these total 10 sites warmth detection threshold (WDT), cool detection threshold (CDT) and~     heat pain threshold (HPT) were assessed using quantitative sensory testing. Tests were~     repeated after a 4-6 weeks interval.~   "
137451|NCT01768117|"~     This study will assess the safety, tolerability and immunogenicity of bivalent rLP2086~     vaccine in laboratory workers ≥18 to ≤65 years of age administered on a Month 0, 2, and 6~     schedule. The study will recruit laboratory personnel (inclusive of Pfizer staff) who work~     directly with pathogenic Neisseria meningitidis in the context of the bivalent rLP2086~     vaccine development program. The study will provide descriptive safety and immunogenicity~     data following vaccination of these individuals with bivalent rLP2086 vaccine.~   "
137452|NCT01768104|"~     The purpose of this study is to determine the efficacy and safety of endoscopic submucosal~     tunnel dissection (ESTD) compared with video-assisted thoracoscopic surgery (VATS) in the~     treatment of upper gastrointestinal submucosal tumors.~   "
137453|NCT01768091|"~     The purpose of this study is to determine the efficacy and safety of peroral endoscopic~     myotomy (POEM) compared with pneumatic dilation in the treatment of esophageal achalasia.~   "
137460|NCT01768000|"~     The purpose of this study is to examine the effectiveness of family cognitive adaptation~     training, including its impact on functioning and caregiver burden. Families that receive the~     manual will be compared with a control group of families that will not receive the manual.~     The larger goal is to add to the tools family members have access to better support their~     family members with schizophrenia.~   "
137461|NCT01767987|"~     The investigators will test if upfront dosing of Ranolazine can reduce myocardial biomarker~     release (CK-MB, Troponin) post percutaneous coronary intervention (PCI).~   "
137462|NCT01767974|"~     Using DNA acquired from tumor tissue, sequencing and PNA-clamping for EGFR gene will be~     performed. The detection rates of EGFR mutation will be compared using paired samples.~   "
137463|NCT01767961|"~     This pilot clinical trial studies the modified barium swallow in measuring swallowing~     function after surgery in patients with oropharyngeal cancer who have undergone surgery. New~     diagnostic procedures, such as the modified barium swallow, may be effective in studying the~     side effects of cancer therapy in patients who received treatment for oropharyngeal cancer~   "
137464|NCT01767948|"~     The purpose of this study is to evaluate the pharmacokinetics (how the drug concentrations~     change over time) of PCI 32765 in participants with mild, moderate, or severe hepatic~     impairment.~   "
137465|NCT01767935|"~     This pilot clinical trial studies cryosurgery and radiation therapy in treating patients with~     painful bone metastases. Cryosurgery kills tumor cells by freezing them. Radiation therapy~     uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors.~     Giving cryosurgery together with radiation therapy may kill more tumor cells~   "
137466|NCT01767922|"~     Objectives of this Multicentre, double-blind study versus placebo were to evaluate impact and~     safety of the daily administration of Extramel® 140 IU SOD for 12 weeks on perceived stress,~     physical and intellectual fatigue, pain perception, if present, and the impact on the quality~     of life of 70 subjects included with 60 that can be evaluated.~   "
137467|NCT01767909|"~     An urgent need exists to find effective treatments for Alzheimer's disease (AD) that can~     arrest or reverse the disease at its earliest stages. The emotional and financial burden of~     AD to patients, family members, and society is enormous, and is predicted to grow~     exponentially as the median population age increases. Current FDA-approved therapies are~     modestly effective at best. This study will examine a novel therapeutic approach using~     intranasal insulin (INI) that has shown promise in short-term clinical trials. If successful,~     information gained from the study has the potential to move INI forward rapidly as a therapy~     for AD. The study will also provide evidence for the mechanisms through which INI may produce~     benefits by examining key cerebral spinal fluid (CSF) biomarkers and hippocampal/entorhinal~     atrophy. These results will have considerable clinical and scientific significance, and~     provide therapeutically-relevant knowledge about insulin's effects on AD pathophysiology.~     Growing evidence has shown that insulin carries out multiple functions in the brain, and that~     insulin dysregulation may contribute to AD pathogenesis.~      This study will examine the effects of intranasally-administered insulin on cognition,~     entorhinal cortex and hippocampal atrophy, and cerebrospinal fluid (CSF) biomarkers in~     amnestic mild cognitive impairment (aMCI) or mild AD. It is hypothesized that after 12 months~     of treatment with INI compared to placebo, subjects will improve performance on a global~     measure of cognition, on a memory composite and on daily function. In addition to the~     examination of CSF biomarkers and hippocampal and entorhinal atrophy, the study aims to~     examine whether baseline AD biomarker profile, gender, or Apolipoprotein epsilon 4 (APOE-ε4)~     allele carriage predict treatment response.~      In this study, 240 people with aMCI or AD will be given either INI or placebo for 12 months,~     following an open-label period of 6 months where all participants will be given active drug.~     The study uses insulin as a therapeutic agent and intranasal administration focusing on nose~     to brain transport as a mode of delivery.~   "
137468|NCT01767896|"~     The purpose of this study is to compare immunogenicity and safety of ASP7374 (cell-culture~     derived influenza vaccine) with those of approved egg-derived trivalent inactivated vaccine~     (TIV) in elderly subjects.~   "
137469|NCT01767883|"~     Background: Chronic Kidney Disease (CKD) is under-recognized and under-treated in primary~     care offices and primary care physicians are generally not familiar with treatment~     guidelines. Even when diagnosed properly, as a chronic condition CKD is frequently associated~     with co-morbidities that make effective treatment difficult due to complexity of care.~     Availability of Clinical Decision Support (CDS) for CKD may help promote effective,~     evidence-based care, but evidence suggests that CDS alone may not be sufficient for quality~     improvement and other interventions such as CDS plus practice facilitation may be needed.~      Purpose: The project aims to: 1) assess the viability of CDS in implementing evidence-based~     guidelines for Primary Care Practices (PCPs) and 2) to develop evidence-based practice~     guidelines that PCPs may use to enhance the care they provide to a difficult to manage~     segment of the healthcare population.~      Methods: This is a randomized controlled trial of point-of-care CDS plus full TRANSLATE model~     of practice change, versus CDS alone. The study aims to analyze differences in promoting~     evidence-based care in primary care practices. Thirty-six practices will be recruited for~     this study. Patient inclusion criteria: adult patients with estimated Glomerular Filtration~     Rate (eGFR) of <60 and >15ml/min/1.73m2 confirmed with repeat testing over three or more~     months. A process evaluation will be conducted between the CDS practices with facilitation~     and the CDS only practices to assess clinical outcomes of CKD progression and all-cause~     mortality. Lastly, a cost-effective analysis will compare the cost-to-benefit ratio of CDS~     alone to that of CDS plus TRANSLATE (i.e. practice facilitation) in relation to cost per~     quality adjusted years of life. This study is funded by NIH NIDDK under R01 mechanism~     starting on 07/01/2011 and ending on 06/30/2016.~   "
137470|NCT01767870|"~     The purpose of this study is to evaluate the efficacy and cost-effectiveness of fecal~     immunochemical test combined with sigmoidoscopy (FITS) for the detection of advanced~     colorectal neoplasia compared to colonoscopy.~   "
137471|NCT01767857|"~     The purpose of this study is to determine if the True Human Monoclonal antibody Xilonix~     (MABp1) can prolong the life of colorectal carcinoma patients that are refractory to standard~     therapy.~   "
137472|NCT01767844|"~     Rheumatoid arthritis (RA) patients typically experience a significant loss of muscle. In~     healthy individuals, food supplementation with creatine (Cr) increases muscle size and~     improves physical function and quality of life. The aim of this study is to investigate~     whether RA patients may benefit similarly.~      50 participants will be given a food supplement to take for 12 weeks; this supplement will~     either be creatine or a placebo (a regular fruit flavoured powder that has no benefits).~      Over 12 weeks, body fat and muscle size (body composition), physical function, and fitness~     (aerobic capacity of the heart and lungs to transport oxygen to the exercising muscles) will~     be tested. In addition, quality of life questionnaires will be completed, disease activity~     will be assessed and blood samples will be taken. Muscle samples (muscle biopsy) will be~     obtained, from those who volunteer to provide them, at baseline and post-treatment.~   "
137528|NCT01767116|"~     The purpose of this study is to evaluate the safety and antiviral activity of~     ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267~     also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin~     (RBV) in patients with chronic hepatitis C virus genotype 1b (HCV GT1b) infection without~     cirrhosis.~   "
137473|NCT01767831|"~     This study combines data collection and simulation-based education, and it will enroll up to~     36 adults with T1DM who already have experience with insulin pump therapy and some experience~     with a continuous glucose monitor (CGM). The study will first track participants for of a~     3-day CGM-training period. The training period will be followed by a 1-week CGM monitoring~     and CGM data collection period. Following the 1-week CGM monitoring-only portion of the~     study, participants will begin the education intervention component of the study, referred to~     as Insight-Based Online Learning Using Simulation and Education for Diabetes (iBOLUSED). The~     education intervention component is 4 weeks in length. The intervention will involve daily~     diary data upload and daily simulation-based feedback based on the collected diary data.~     During the first week (and for up to 2 weeks) of the intervention, participants will view~     glycemic outcome data that represents the participant's hypo- and hyperglycemic risk~     throughout the day, based on the CGM data collected during the CGM monitoring period. In the~     next 2 weeks of the intervention, participants will have an opportunity to interact with the~     internet-based system using a simulation-based tool designed to provide insight to the~     participant regarding the different effects of modifications to insulin therapy. Throughout~     the educational intervention, participants will record diary data every day through the use~     of a diary component in the internet-based system. Diary entries include data on meals,~     physical activity, history of the insulin basal rate and insulin boluses given that day,~     self-reported stress level, hypo- and hyperglycemic fear levels, and, if applicable,~     menstrual cycle and any physical illness. Participants will also upload data from the CGM via~     the Dexcom Data Manager 3 (DM3) software or the Dexcom Studio Software. Two assessments, one~     prior to the intervention period and one following the intervention, will be administered to~     gather relevant psychobehavioral information. Focus group sessions will be conducted at the~     end of the study, which will allow for the collection of information regarding the~     effectiveness of the Internet intervention and will provide insight for the design of future~     studies. Parallel recording of CGM, insulin, and behavioral data, as well as psychometric~     instruments, will produce a rich synchronized data set for each person that will facilitate~     the development of personalized behavioral profiles that will be employed to provide~     individualized feedback to educate participants. In particular, this study tests the use of~     collected diary data to educate participants by describing glucose profile information and~     presenting relevant data regarding: (1) hypo- and hyperglycemia risk zones throughout the~     day, (2) insulin meal bolus information and associated glycemic outcome indices, and (3)~     basal rate information with associated glycemic outcome indices.~   "
137474|NCT01767818|"~     The primary objective of this study is to obtain detailed clinical information and biologic~     specimens from subjects with PD toward the ultimate end of identifying a biomarker of PD.~     Because of the inherent difficulties of using clinical outcome measures to assess disease~     modification, the identification of biomarkers of PD is of paramount importance. The ideal PD~     biomarker would be one that is easily assayed in a convenient biological sample, varies~     proportionally with disease severity, is abnormal during the pre-symptomatic phase of the~     illness, and is unaffected by drugs or other interventions used to treat PD. The existence of~     a sensitive biomarker with these properties would enable much more effective disease~     modifying research that would likely be able to take advantage of smaller and potentially~     shorter trials.~   "
137475|NCT01767805|"~     The purpose of this study is to compare different culture conditions. The effect of the type~     of incubator (standard versus mini-incubator) and the effect of the oxygen concentration (5%~     versus 20%) will be evaluated on the embryo quality~   "
137476|NCT01767792|"~     To determine the hearing response rate at 24 weeks after treatment with bevacizumab for~     symptomatic vestibular schwannomas (VS) in children and young adults with NF2.~   "
137477|NCT01767779|"~     To determine whether EEGs during infancy is a reliable biomarker to identify TSC patients~     that will develop infantile spasms/epilepsy in the near future and thus are appropriate~     candidates for an antiepileptogenic drug trial. Since not all patients with TSC develop~     epilepsy, it would be useful to have a biomarker that could predict those patients destined~     to have epilepsy and thus identify those TSC patients most appropriate for an~     antiepileptogenic drug trial. A recent study suggests that treating TSC patients with an~     abnormal EEG prior to onset of infantile spasms with vigabatrin may improve neurological~     outcome, but the use of EEG as a reliable biomarker of future epilepsy has not been~     rigorously validated. In this specific aim, we will test the reliability of EEG in predicting~     future development of infantile spasms or epilepsy in TSC patients during the first year of~     life.~   "
137478|NCT01767766|"~     The purpose of this study is to evaluate the safety and effectiveness of TGR-1202 in patients~     with advanced hematologic malignancies.~   "
137479|NCT01767753|"~     Selective laser trabeculoplasty (SLT) is an increasingly popular treatment modality in~     early-to-moderate glaucoma patients. SLT has been suggested to reduce IOP more consistently~     during the nocturnal period than during the diurnal period in a group of medically-treated~     patients with primary open angle glaucoma (POAG). At present, there is scarce data on SLT~     effects on the 24-hour IOP pattern in patients with glaucoma and there is no data on the~     24-hour effect of SLT in untreated glaucoma patients.~      The purpose of this study is to assess the changes of IOP over a 24-hour period in patients~     with glaucoma undergoing SLT.~   "
137480|NCT01767740|"~     The primary objective of this study is to obtain safety data on the use of the ULTRABRAID~     PLUS SUTURE, and to assess the preliminary effectiveness of the use of the ULTRABRAID PLUS~     SUTURE in comparison to the ULTRABRAID SUTURE in patients undergoing rotator cuff repair.~   "
137481|NCT01767727|"~     Multiple finger defects are common in hand trauma and result in functional disability. These~     injuries are often complex and severe, and thus reconstructive alternatives are limited. In~     this study, we use the dorsal homodigital island flaps, based on the dorsal branch of the~     digital artery, for reconstruction of multiple finger defects. At the final follow-up, we~     would evaluate the efficacy of this technique.~   "
137482|NCT01767714|"~     The study is to determine if NHL patients mobilized with G-CSF (10 µg/kg/day [GRAN® only])~     plus 0.24 mg/kg/day of plerixafor are more likely to achieve a target number of ≥5 × 10^6~     CD34+ cells/kg in 4 or fewer days of apheresis than NHL patients mobilized with G-CSF plus~     placebo.~   "
137483|NCT01767701|"~     The purpose of this study is to determine whether raltegravir is effective in preventing~     progression of relapsing remitting multiple sclerosis as determined by gadolinium- enhanced~     MRI.~   "
137484|NCT01767688|"~     This study will investigate and compare the pharmacokinetics of a single 25-mg dose of~     MK-3102 in participants with moderate hepatic impairment and matched healthy participants.~     The primary hypothesis is that in participants with moderately impaired hepatic function, the~     area under the concentration-time curve from time zero to infinity (AUC0-∞) is similar to~     that observed in healthy matched control participants following a single 25 mg oral dose of~     MK-3102. Specifically, the true ratio (moderately impaired hepatic function patients/healthy~     matched control subjects) of geometric means for AUC0-∞ is no greater than 2.~   "
137529|NCT01767103|"~     Multi-center, non-randomized, open-label, single-dose, parallel group study to determine the~     effect of impaired hepatic function on the PK of deferiprone and its 3-O-glucuronide~     metabolite following a single oral dose of 33mg/kg Ferriprox®.~   "
137589|NCT01766310|"~     The purpose of the present study was to determine whether folic acid supplementation could~     reduce plasma homocysteine in obese children and to determine the association between dietary~     folate, serum folate and homocysteine level through the randomized double blinded placebo~     controlled trial.~   "
137485|NCT01767675|"~     The purpose of this study is to see if the investigators can improve the treatment of this~     type of cancer. They want to find out what effects, good and/or bad, giving heated~     chemotherapy into the belly, known as hyperthermic intraperitoneal chemotherapy (HIPEC), has~     on the patient and this type of cancer.~      The goal of HIPEC is to expose any cancer left in the abdomen after surgery to high doses of~     chemotherapy. The chemotherapy is heated in the hope that this will make it easier for it to~     get into and kill the cancer cells. The drug used for HIPEC will be carboplatin, a Food and~     Drug Administration (FDA) approved drug for use in ovarian, fallopian tube or primary~     peritoneal cancer.~   "
137486|NCT01767662|"~     The purpose of this study is to determine effectiveness of parents' manipulation in newborn~     with talipes calcaneovalgus over observation group.~   "
137487|NCT01767649|"~     The purpose of this study is to identify molecules produced specifically by the cells from~     the chorionic membranes of the materno-fetal interface (the water bag) sign for the~     activation of preterm labor.~   "
137488|NCT01767636|"~     This phase II trial studies how well pazopanib hydrochloride works in treating patients with~     kidney cancer that has spread to other places in the body (metastatic). Pazopanib~     hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for~     cell growth. Pazopanib hydrochloride may also stop the growth of kidney cancer by blocking~     blood flow to the tumor.~   "
137489|NCT01767623|"~     This open-label, Phase I study will evaluate the impact of severe hepatic impairment on the~     pharmacokinetics and safety of vemurafenib in participants with BRAF V600 mutation positive~     cancer. Participants will receive vemurafenib 960 milligrams (mg) (normal hepatic function)~     or 720 mg (severe hepatic impairment) orally twice daily (BID) on Days 1 to 20 (morning dose)~     and from Day 27 onward until disease progression or unacceptable toxicity occurs.~   "
137490|NCT01767610|"~     To develop combination product of micronized fenofibrate plus pitavastatin, we would like to~     evaluate pharmacokinetic drug interaction by comparing the steady-state pharmacokinetic~     characteristics of each arms after repeated administrating Lipilfen cap. 160mg(micronized~     fenofibrate 160mg)by Dae Woong Pharma. and Livaro tab. 2mg (pitavastatin Ca 2mg) by Joong Wae~     Pharm. through 3 period by separately or combinedly.~   "
137491|NCT01767597|"~     With over 280 000 chronic carriers, 2,500 new annual cases and 1,300 deaths each year,~     hepatitis B is currently a frequent and potentially severe disease in France, despite efforts~     towards prevention and effective care.~      In terms of prevention, France has very low immunization coverage (27.7%) and a high~     percentage of people ignoring HBV status (55%), leading to a delay in care. This is partly~     explained by poor knowledge of hepatitis B infection in the general population and an~     underestimation of the health impact of hepatitis B by doctors and health officials. Until~     recently, there have been no national guidelines governing its implementation (which is~     variable depending on the structures where screening is performed) and an insufficient~     evaluation of screening practices. Thus, data on the severity of liver disease, indications~     for treatment of HBV-infected patients and data on the use of vaccination for nonimmunized~     people are scarce. Furthermore, while HIV rapid tests are beginning to be used more widely,~     particularly to address the issue of people who do not come back and collect their results~     and to better adapt counselling, their usefulness to detect of hepatitis B virus has not~     been evaluated to date.~      The main objective of the Optiscreen B Study is to determine the benefit, if any, of using~     rapid tests as a screening tool to improve diagnosis, care and prevention of hepatitis B.~     Individuals risk of HBV-infection will be randomized into 2 groups, one group for which~     screening will be performed by usual serological test and a second group for which screening~     will be based on rapid tests. Centers will be selected to represent a diverse range of health~     centers whose aims include screening, prevention and/or vaccination.~   "
137492|NCT01767584|"~     The objective of this study was to confirm if two formulations of cephalexin tablets are~     bioequivalent.~      Test product was Ceporex® (1 g Cephalexin; GlaxoSmithKline) and reference product Keflex® (1~     g Cephalexin; Eli Lilly). The single dosage was one tablet.~      The study was prospective, open-label, randomized, crossover, single dose, with 02~     treatments, 02 sequences and 02 periods, under fasting conditions.~      The population was composed of 26 healthy volunteers, both genders, adults between 18-40~     years.~      The comparative bioavailability of the two formulations was evaluated based in statistical~     comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations~     in blood.~   "
137493|NCT01767571|"~     The objective of this study was to confirm if two formulations of cephalexin suspension are~     bioequivalent.~      Test product was Ceporex® (250 mg Cephalexin / 5 ml; GlaxoSmithKline) and reference product~     Keflex® (125 mg Cephalexin / 5 ml; Eli Lilly). The single dosage was 10 ml of suspension for~     Ceporex and 20 ml of suspension for Keflex® .~      The study was prospective, open-label, randomized, crossover, single dose, with 02~     treatments, 02 sequences and 02 periods, under fasting conditions.~      The population was composed of 28 healthy volunteers, both genders, adults between 18-50~     years.~      The comparative bioavailability of the two formulations was evaluated based in statistical~     comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations~     in blood.~   "
137494|NCT01767558|"~     PRECISION GOLD is a prospective, multi-center, single arm, unblinded interventional post~     market clinical study conducted in Europe. The purpose of the study is to evaluate~     asymptomatic cerebral embolic (ACE) lesions in subjects with symptomatic paroxysmal atrial~     fibrillation undergoing ablation with the Pulmonary Vein Ablation Catheter (PVAC) GOLD.~   "
137495|NCT01767545|"~     To evaluate the efficacy and safety of a dexamethasone-implant alone or in combination with~     bevacizumab. 64 eyes are prospectively investigated. Group 1 (22 CRVO and 16 BRVO) is treated~     with dexamethasone-implant alone, Group 2 (14 CRVO 12 BRVO) with three consecutive~     bevacizumab injections followed by a dexamethasone-implant. Recurrences are treated with~     dexamethasone-implant only. Patients are seen preoperatively and thereafter in monthly~     intervals. The primary endpoint was BCVA at twelve months.~   "
137530|NCT01767090|"~     The main objective for this study is to assess the efficacy and dose-response relationship of~     ASP1707 in reduction of endometriosis associated pelvic pain. The secondary objectives are to~     assess the safety, tolerability, Pharmacokinetics of ASP1707, dose response relationship of~     ASP1707 in reduction of E2 (Estradiol), 24-week efficacy of ASP1707 in reduction of~     endometriosis associated pain and 24-week safety and tolerability of ASP1707.~   "
137496|NCT01767532|"~     The objective of this study was to confirm if two formulations of cephalexin suspension are~     bioequivalent.~      Test product was Ceporex® (125 mg Cephalexin / 5 ml; GlaxoSmithKline) and reference product~     Keflex® (125 mg Cephalexin / 5 ml; Eli Lilly). The single dosage was 20 ml of suspension.~      The study was prospective, open-label, randomized, crossover, single dose, with 02~     treatments, 02 sequences and 02 periods, under fasting conditions.~      The population was composed of 28 healthy volunteers, both genders, adults between 18-50~     years.~      The comparative bioavailability of the two formulations was evaluated based in statistical~     comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations~     in blood.~   "
137497|NCT01767519|"~     A study to evaluate the efficacy and safety of BOTOX® or Solifenacin in patients with~     overactive bladder (OAB) and urinary incontinence.~   "
137498|NCT01767506|"~     Infection with C. Trachomatis has decreased substantially in trachoma endemic areas following~     repeated annual mass drug administration (MDA) with azithromycin, although not as rapidly as~     anticipated. The investigators propose to conduct a clinical trial in 52 communities in~     Kongwa, Tanzania that on average have trachoma infection at 3.5%. The investigators plan that~     all communities would have annual rounds of MDA if infection is greater than 1% or follicular~     trachoma (TF) is 5% or more, but half would be randomized to a surveillance and treatment~     program to identify and treat new families and families who travel after mass treatment.~     Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will~     be reinstated if infection re-emerges to 6% or more. The proportion of communities that are~     able to stop mass treatment will be compared in the group of communities randomized to mass~     treatment plus the newcomer/traveler treatment program compared to the communities randomized~     to mass treatment alone after 24 months.~      At the recommendation of the Data Safety and Monitoring Committee in March 2015, thirty eight~     (38) of the 52 communities identified as being at risk of trachoma re-emergence at 18 months~     will be surveyed at 30 months. At risk of trachoma re-infection communities have C.~     trachomatis infection rates less than or equal to 1% or TF < 5% at the time of the 18 month~     survey. Surveillance of communities for families that meet the newcomer or traveler status~     will extend 6 months beyond the 24 month survey to 30 months in the intervention communities~     only. A survey of sentinel children in the intervention and control communities at 30 months~     will be conducted to assess the level of trachoma and infection in all 38 communities at risk~     of trachoma re-emergence.~   "
137499|NCT01767493|"~     The purpose of this study is to evaluate the feasibility of [18F]Florbetapir positron~     emission tomography (PET) for assessment of demyelination in the patients with relapsing~     remitting multiple sclerosis.~   "
137500|NCT01767480|"~     Robot-assisted training (RT) devices developed to date have a significant impact on stroke~     rehabilitation. Several research groups have developed the robotic devices and examined their~     efficacy on improving upper limb function after stroke. All these robotic devices have been~     applied in stroke rehabilitation and their efficacy are evaluated, but the scientific~     evidence for the mechanisms of RT-induced recovery, the optimal treatment intensity, and the~     impact on physiological responses is still lacking.~      This trial is to examine (1) the immediate effects of treatment intensity in RT on~     sensorimotor impairments and functional performance in patients with subacute stroke; (2) the~     long-term benefits of treatment intensity in RT by conducting a 6-month follow up evaluation;~     and (3) the effects of RT on cortical/movement reorganization as well as on the physiological~     markers of inflammation, oxidative stress, and erythrocyte deformability. These overall~     findings will help better understanding of the efficacy of RT on functional outcomes, brain~     and movement reorganization, and physiological markers.~   "
137501|NCT01767467|"~     The purpose of this study is to evaluate the safety and immunogenicity of GSK Biologicals'~     vaccine GSK1437173A in subjects aged 18 years and older with blood cancers. The study will~     evaluate safety-related events and antibody and cellular immune responses to the study~     vaccine, as compared to placebo.~   "
137502|NCT01767454|"~     This is an open-label, multi-center, dose-finding Phase 1 study that will enroll subjects at~     least 18 years old with unresectable or metastatic melanoma and BRAF V600 mutations. The~     primary objective of the study is to describe the safety for the doublet therapy (dabrafenib~     and ipilimumab) and the triplet therapy (dabrafenib/trametinib and ipilimumab). Preliminary~     efficacy data will also be collected. Subjects will be assigned to receive either the doublet~     combination (dabrafenib and ipilimumab) or the triplet combination (dabrafenib, trametinib,~     and ipilimumab). Subjects will be enrolled to dose-finding cohorts in the doublet combination~     (dabrafenib + ipilimumab) in a sequential 3+3 fashion. Following establishment of a dose for~     the doublet combination, an expansion cohort will be opened. At the same time, enrollment to~     dose finding cohorts for the triplet combination (dabrafenib + trametinib + ipilimumab) will~     begin in a sequential 6+6 fashion. Enrollment into triplet cohorts will take priority when~     both the doublet expansion arm and the triplet dose-finding arm are open for enrollment at~     the same time. Approximately 9-24 subjects will be enrolled to the dose finding portion of~     the study. Approximately 30 subjects will be enrolled to doublet expansion cohort and 30~     subjects will be enrolled in the triplet expansion cohort. A two-week run-in period without~     ipilimumab will be followed by 4 intravenous doses of ipilimumab at the recommended dose and~     schedule. Oral daily dosing of dabrafenib or dabrafenib + trametinib will continue from the~     two-week run-in, through combination with ipilimumab, and post-ipilimumab until no longer of~     clinical benefit, in the opinion of the treating physician, or until unacceptable AE or death~   "
137503|NCT01767441|"~     Bariatric surgery can lead to improvement or even resolution of type 2 diabetes Mellitus~     (T2DM) with the spectrum of responses depending also on operation procedures. However, many~     mechanisms of metabolic action of different surgical techniques still are unclear.~      The aim of this study is to provide a better understanding of the effects of three types of~     bariatric surgery (lap banding, gastric bypass and sleeve gastrectomy) on beta-cell function~     and incretin secretion. A mixed meal tolerance (MMT) test will be performed before and 1 and~     12 months after surgery to assess beta cell adequacy and glucagon-like-peptide-1~     (GLP1)/glucose-dependent insulinotropic polypeptide (GIP) bioavailability.~   "
137504|NCT01767428|"~     A pharmacokinetic study in healthy volunteers comparing two formulations of paracetamol fast~     release in fasted state.~   "
137505|NCT01767415|"~     The purpose of this study is to investigate whether stereotactic indigo carmine injection can~     safely increase the extent of tumor resection.~   "
137507|NCT01767389|"~     This study will assess the utilization patterns (adherence, source of the index antidiabetic~     agent (ADA) and treatment modification) of the marketed glucagon-like peptide-1 (GLP-1)~     receptor agonists (exenatide and liraglutide), dipeptidyl-peptidase-4 (DPP-4) inhibitors~     (sitagliptin, saxagliptin, and linagliptin) and other ADAs and the incidence rate of acute~     pancreatitis among the users of these GLP-1 receptor agonists and users of DPP-4 inhibitors,~     separately, in comparison to other ADAs.~      The proposed study will help in understanding the treatment utilization patterns and the~     incidence rate of acute pancreatitis among users of the marketed GLP-1 receptor agonists.~     This study differs from previous observational studies by including both exenatide and~     liraglutide and follow-up time is expected to be longer in the current study (2005 - 2011).~      This study will be a retrospective cohort study conducted in the Truven (Thomson Reuters)~     commercial health insurance database from 2005-2011.~   "
137508|NCT01767376|"~     The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the~     meningococcal conjugate vaccine (MenACWY-TT) co-administered with Boostrix® versus each of~     the two vaccines given separately in healthy adolescents and young adults.~   "
137509|NCT01767363|"~     This retrospective cohort study will assess the association of benign prostatic hyperplasia~     (BPH) treatment (5-alpha reductase inhibitors (5ARI) and alpha-blocker medications) with the~     occurrence of prostate cancer related mortality. This study will also assess a number of~     secondary endpoints including prostate cancer mortality or metastatic prostate cancer, and~     all cause mortality.~   "
137510|NCT01767350|"~     The long-term success of solid organ transplantation is largely dependent on the efficacy of~     immunosuppressive medication. Unfortunately, for the most important agents the correct drug~     levels are difficult to attain, with potential severe consequences of drug under- or~     overexposure. In addition there is a large variation in dose requirements within and between~     different subjects. Clinical studies have demonstrated that a better control of drug exposure~     can improve outcome. A large set of patient characteristics appear important in determining~     dose requirements in adults, in particular genetic variation in genes involved in drug~     metabolism. In children relative dose requirements are increased compared to adults, but is~     not known why and the role of pharmacogenetic variation has not been described.~      Our study aims to describe relative dose requirements in children after solid organ~     transplantation with the help of clinical and laboratory data obtained during regular~     hospital visits (retrospective). In addition we will assess their genotype for genes involved~     in the metabolism of immunosuppressives.~   "
137511|NCT01767337|"~     This study will evaluate intracutaneous delivery of 0.1, 0.25 and 0.5 milliliter volumes of~     saline from the FLUGEN 101.2 investigational microneedle-based device.~   "
137512|NCT01767324|"~     The goal of this exploratory study is to select the optimal body site for intracutaneous~     delivery of 0.5 milliliters of saline from the FLUGEN 101.2 microneedle-based device.~   "
137513|NCT01767311|"~     This is a multinational, multicenter, double-blind, placebo-controlled, parallel-group study~     using a Bayesian design with response adaptive randomization across placebo or 5 active arms~     of BAN2401 to determine clinical efficacy and to explore the dose response of BAN2401 using a~     composite clinical score (ADCOMS). BAN2401-G000-201 is an 18-month study in which 3 dose~     levels (2.5, 5, and 10 mg/kg) are given biweekly (once every 2 weeks) to separate groups of~     participants and 2 dose levels (5 and 10 mg/kg) are given monthly to separate groups of~     participants. Participants will be from 2 clinical subgroups: mild cognitive impairment (MCI)~     due to Alzheimer's disease (AD) or mild Alzheimer's disease dementia. Frequent interim~     analyses will be conducted to continually update randomization allocation on the basis of the~     primary clinical endpoint. In the event of early success in the Core Study at any interim~     analysis (IA) or at the Bayesian analysis at 12 months of treatment, an open label extension~     (OLE) Phase will be implemented to allow for up to 60 months (5 years) of additional~     treatment. The OLE will not be conducted if early success is not achieved at any IA or at the~     Bayesian analysis at 12 months of treatment.~   "
137514|NCT01767298|"~     This study was conducted to compare the rate and extent of absorption of valsartan and~     hydrochlorothiazide. To maximize the possibility of finding drug-drug interactions, the dose~     of valsartan and hydrochlorothiazide was doubled (320 mg of VAL and 25 mg of HCT).~   "
137515|NCT01767285|"~     The investigators are examining if there is a difference in continuation rates of the~     etonogestrel contraceptive implant between women who have the device placed immediately after~     delivery, before leaving the hospital, and women who have the device placed at the routine~     6-week postpartum visit. There will be 60 subjects total, randomized in a 1:1 ratio, for 30~     in each group. All participants will follow-up at the same postpartum clinic 6 weeks after~     delivery. They will then be contacted at 3, 6, and 12 months postpartum and asked to complete~     a brief survey. The investigators hypothesize that continuation rates of Implanon will be~     higher in the immediate postpartum placement arm than in the delayed placement arm.~   "
137516|NCT01767272|"~     The present study was adopted to evaluate the pharmacokinetics and dose linearity of~     fexofenadine after oral administration.~   "
137517|NCT01767259|"~     This study was conducted to compare the rate and extent of absorption of valsartan and~     hydrochlorothiazide following oral administration as a fixed dose combination tablet and~     concomitant administration of the individual drugs under fasting conditions in healthy~     Egyptian subjects. The study was extended to investigate any potential reaction between VAL~     and HCT.~   "
137531|NCT01767077|"~     Investigate the effects of milk fat with or without milk fat globule membranes (MFGM) on~     blood lipid profile, vascular function, insulin sensitivity, inflammation and gene~     expression. Overweight subjects will be randomized to one of 2 groups with different types of~     dairy products: 1)butter oil; 2) cream (milk fat with MFGM).~   "
137539|NCT01766973|"~     Recent evidence suggests that chronic pain is associated with abnormal connectivity between~     brain regions associated with the processing of pain. We aim to test the diagnostic power of~     resting state functional magnetic resonance imaging (MRI) to diagnose patients with chronic~     back pain. Using new methods of image acquisition and analysis we aim to develop a~     computational method to correctly classify patients and matched control subjects.~   "
137773|NCT01763918|"~     The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneously~     once every 2 weeks (Q2W) and once monthly (QM), compared with placebo, on percent change from~     baseline in low-density lipoprotein cholesterol (LDL-C) in adults with heterozygous familial~     hypercholesterolemia (HeFH).~   "
137518|NCT01767246|"~     Patients who are diagnosed with Patellofemoral Pain Syndrome (PFS) and present to our clinic~     will be offered the opportunity to participate in the study. If they consent to be in this~     study they will randomized into 2 treatment groups. The experimental treatment group will be~     treated according to the novel PFS treatment algorithm. The control group will receive~     treatment that would be considered standard physical therapy care. To apply standard physical~     therapy care in a standardized manner the investigators are using a multimodal treatment~     approach that has been previously shown by Lowry to be beneficial in the treatment of PFS.~     Both groups of subjects will be seen 2 times per week for a maximum of 12 visits. Patients~     can be discharged early if they no longer report pain or impaired function on the Anterior~     Knee Pain scale.~      The purpose of this study is to see if patients with patellofemoral pain syndrome treated~     with the experimental Patellofemoral treatment algorithm experience significant improvements~     in function, pain and the number of treatment sessions compared with a previously researched~     multimodal approach to the treatment of patellofemoral pain.~      The secondary objective of this study is to examine results to determine if a full randomized~     controlled clinical trial of the PFS algorithm is justified.~      The investigators hypothesize that utilization of the Patellofemoral syndrome treatment~     algorithm with evaluation and treatment of patients diagnosed with PFS will lead to~     significant improvements in function, pain and the number of treatment sessions when compared~     to previously researched treatment of PFS.~   "
137519|NCT01767233|"~     Since the majority of patients with necrotizing pancreatitis will experience a leak from the~     pancreatic duct during their course of disease resulting in intra- and peripancreatic fluid~     collections, it is reasonable to hypothesize that placement of a ductal stent may prevent~     some of the late complications and morbidity associated with pancreatic necrosis. This~     prospective, randomized, controlled multicenter trial investigates the role of early~     prophylactic ductal stenting in acute necrotizing pancreatitis.~      The purpose of the study is to determinate the safety and feasibility of early prophylactic~     pancreatic duct stenting in necrotizing pancreatitis in reducing complications, length of~     stay in hospital and in in-tensive care unit compared to the traditional treatment.~   "
137520|NCT01767220|"~     A significant portion of patients with cardiac diseases like coronary artery disease (CAD),~     dilated cardiomyopathy (DCM) and arrhythmogenic right ventricular cardiomyopathy (ARVC)~     develops ventricular tachycardia (VT). The standard ablation procedure is carried out from~     endocardial only. In 30% of patients treated this way a successful ablation is not possible.~     In these cases the scar areas are mostly located in the outer layer of the myocardium.~     Ablation is feasible only if the catheter is placed in the epicardial space to reach the~     surface of the heart muscle. In the past this type of ablation was performed as a second~     procedure in case of recurrent VTs after unsuccessful endocardial ablation.~      This prospective randomized trial compares the standard ablation procedure (endocardial~     ablation only) with a new strategy. This means in a single procedure the scar areas~     responsible for VT are marked and obliterated from endocardial as well as from epicardial.~     The primary endpoint is recurrence of VT after endo- and epicardial vs. endocardial ablation~     only.~      40 patients will be enrolled. They will be randomized 1:1 in the study arms strategy 1~     which is standard endocardial ablation and strategy 2 which is endo- and epicardial~     ablation.~      At least 12 months are planned for enrollment. The study is closed if the patient last~     enrolled has completed the 12-months-follow up. Follow up visits are scheduled 3, 6 and 12~     months after the ablation procedure. Recurrence of VT is monitored by ICD (implanted~     cardioverter defibrillator) interrogation.~      Both ablation strategies are well established and conducted with standard equipment. The~     methodology of this study does not contain any experimental approaches. The standard~     insurance coverage of the hospital is guaranteed for all enrolled patients.~   "
137521|NCT01767207|"~     Patients referred to pediatric rehabilitation services have often cognitive~     deficits/intellectual disabilities.Neurocognitive assessment is, hence, important when~     designing treatment plans.~      Children and adolescents with cognitive deficits and intellectual disabilities (ID) have a~     high risk of developing mental health problems. There is lack of knowledge about such~     comorbid mental disorders in the health service. There are also few validated instruments for~     assessing mental disorders among children and adolescents with cognitive deficits and ID both~     in Norway and abroad.~      The main aims of the current multicentre study are to:~      Investigate psychometric properties of different psychiatric instruments for children and~     adolescents. Investigate change and stability of symptoms over time. Investigate user~     satisfaction. The study will include Pediatric Rehabilitation Services at hospitals in~     Tromsø, Hammerfest and Bodø and will include in total 320 patients aged 4 to 18. We will use~     information from parents, teachers and patients, in addition to clinician-rated measures.~     Patients will be assessed at intake and after six months. We have conducted a pilot study in~     the period from 2012 to 2013.~   "
137522|NCT01767194|"~     This randomized phase II trial studies how well irinotecan hydrochloride and temozolomide~     with temsirolimus or dinutuximab work in treating younger patients with neuroblastoma that~     has returned or does not respond to treatment. Drugs used in chemotherapy, such as irinotecan~     hydrochloride and temozolomide, work in different ways to stop the growth of tumor cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Monoclonal antibodies, such as dinutuximab, may find tumor cells and~     help kill them or carry tumor-killing substances to them. It is not yet known whether giving~     irinotecan hydrochloride and temozolomide together with temsirolimus or dinutuximab is more~     effective in treating neuroblastoma.~   "
137523|NCT01767181|"~     EuRhythDia is a multicenter, controlled and randomized study. The aim of the study is to~     investigate the effects of 12 weeks of randomized timed light therapy or timed physical~     exercise as a chronotherapeutic lifestyle intervention on markers of central and peripheral~     circadian rhythms and cardiometabolic function in healthy night shift workers.~   "
137524|NCT01767168|"~     The purpose of this study is to test the hypothesis that a preoperative test of pain~     modulation predicts persistent pain 4 months after breast cancer surgery. In addition, a risk~     score for the prediction of persistent pain will be developed from parameters available~     before surgery.~   "
137525|NCT01767155|"~     Open-label, randomized, active-controlled, two-arm Phase III study to compare the efficacy~     and safety of AEZS-108 and doxorubicin. The study will include about 500 patients with~     endometrial cancer resistant to platinum/taxane-based chemotherapy.~   "
137532|NCT01767064|"~     Inappropriate antibiotic prescribing for acute respiratory infections (ARIs) persists despite~     decades of intervention efforts. Negative outcomes of inappropriate antibiotics include~     increased costs of care, adverse drug reactions, and rising prevalence of~     antibiotic-resistant bacteria. To address this public health problem, we apply the principles~     of commitment and consistency in an effort to influence clinician decision-making through the~     implementation of a low-cost behavioral nudge in the form of a simple public commitment~     device. Clinicians were asked to post in their exam room a signed letter indicating their~     commitments to reducing inappropriate antibiotic use for ARIs. Our hypothesis is that~     clinicians displaying the poster-sized commitment letters will decrease their inappropriate~     antibiotic prescribing for ARIs as compared to clinicians in the control condition (with no~     posted letter).~   "
137533|NCT01767051|"~     Polycystic ovary syndrome (PCOS) is a complex and frequent disorder with a heterogeneous~     clinical presentation varying throughout life, from birth up to post-menopause. Although~     mostly known for its reproductive consequences, PCOS is associated with metabolic~     abnormalities related to insulin resistance and obesity. Children born from PCOS mothers are~     considered to be at risk for early insulin resistance, leading to development of PCOS and~     metabolic abnormalities in childhood and adolescence. Obesity and insulin resistance are~     considered as states of low- and pro-inflammation associated with endothelial dysfunction. In~     addition, it has been shown that endothelial dysfunction develops from the first decade of~     life in response to genetic and environmental risk factors. Therefore, offspring of women~     with PCOS may be at increased risk for vascular disease later in life. Moreover, some~     evidence suggests that early life respiratory disease also contributes to later life~     cardiovascular consequences. The number of studies on offspring of PCOS mothers is low and a~     systematic follow up of children born form PCOS mothers has not been performed yet. the~     investigators propose a systematic evaluation of cardiometabolic and pulmonary health~     characteristics of children (aged 2,5-8 years) born from mothers diagnosed with PCOS. A~     saliva sample will be performed to determine the biochemical androgenic status of the~     children. Mothers of these children have undergone standardized phenotyping prior to~     conception; the investigators will therefore be able to correlate the metabolic status of the~     mother around the time of conception and the cardiometabolic and pulmonary health of their~     offspring.~   "
137534|NCT01767038|"~     Patients with retinal detachment do not always recover good visual function. Sometimes simple~     causes are responsible. Other causes can only be discovered thanks to high-resolution imaging~     provided by the latest generation of OCT.~      This study is possible thanks to surgical teams who have a strong recruitment potential, with~     the experience of a joint project in 2007-2008 (PHRC national - Etude DOREMY, Etude FRIENDS)~     to define more strict intervention criteria. The principal objective of this study is to~     better define with regard to time:~        -  The onset of surgically curable or transient macular affections, and losses in visual~          acuity that can be qualified as explained~        -  But above all to better understand the relationships between anatomical analyses~          obtained using OCT and autofluorescence and functional analysis using visual acuity and~          microperimetry.~        -  In the near future, two techniques (OCT and microperimetry) will certainly become~          essential tools in the evaluation of macular function. Better understanding of these~          relationships is the first necessary step in any study concerning the therapeutic~          prevention of retinal lesions related to retinal detachment: This study will make it~          possible to define criteria for the evaluation of anatomical and functional recovery,~          their relationship with each other and finally their evolution over time. This is an~          essential first phase before possible therapies can be evaluated.~   "
137535|NCT01767025|"~     In this study, the influence of oxytocin on automatic imitation behaviour is investigated.~     Healthy adults will be administered with either oxytocin or a placebo, and will perform an~     imitation-inhibition task (as a measure of automatic imitation behaviour). To determine the~     specificity of the oxytocin effect, an unrelated cognitive task (Stroop task) will also be~     presented.~   "
137536|NCT01767012|"~     Modern phacoemulsification techniques have made cataract surgery safe and efficient over the~     past several decades. Although the phacoemulsification procedure has improved greatly,~     cataract surgery still involves trauma. One of the surgical traumas during cataract surgery~     is the direct trauma of the anterior uvea, resulting in a later chronic immune reaction of~     the uvea to the implanted intraocular lens (IOL). 1 The breakdown of the blood-aqueous~     barrier (a measure of the uveal reaction) clinically presents as flare in the anterior~     chamber. 2 Petternel et al. 3 explained that the protein content of the aqueous humor may~     mainly arise from the iris root and iris vessels in the anterior chamber. The peak of this~     flare and cell intensity in the anterior chamber was shown to be reached during the first two~     days after cataract surgery 4 and flare levels were back to the preoperative values about one~     year after cataract surgery. 5, 6 Influencing factors are surgical technique 7, perioperative~     treatment 8, IOL biomaterial and design 9 and host reaction to the IOL.~      In this study the otherwise same IOL concerning material and design, but one with a new~     surface modification will be compared to assess the influence on aqueous flare and cell~     intensity in the anterior chamber. The Polylens (Polytech, Rossdorf, Germany) is a~     hydrophobic acrylic single-piece open-loop IOL and is available with the standard surface and~     a novel modified surface.~      To assess the efficacy of the newly modified surface of the Polylens IOL compared to the same~     IOL without a modified surface concerning flare and cell intensity in the anterior chamber as~     well as cellular components on the IOL surface and lens epithelial out-growth from the rhexis~     after cataract surgery in eyes of patients with diabetes mellitus and pseudoexfoliation~     syndrome, which typically have a higher incidence of post-operative intra-ocular~     inflammation.~   "
137537|NCT01766999|"~     Tumescent local anesthesia is a procedure which is frequently performed for plastic cosmetic~     surgical procedures such as liposuction. The subcutaneous adipose tissue is infiltrated with~     large volumes of a solution which also contain local anesthetics. However local anesthetics,~     can also lead to a marked production of methemoglobin. New generation pulse oximeters are~     able to measure SpMetHb non-invasivly.~      The aim of this study is:~        1. to investigate multi-wavelength pulse oximetry as a monitoring method for patients at~          increased risk for methemoglobinemia.~        2. to illustrate MetHb concentrations over a course of 24 hours after a liposuction~          employing tumescent anesthesia has been carried out.~   "
137538|NCT01766986|"~     Background: Owing to controversial staging and classification of adenocarcinoma of the~     oesophagogastric junction (AOG) before surgery, the choice of appropriate surgical approach~     remains problematic.~      In a retrospective study, preoperative staging of AOG and the impact of preoperative~     misclassification on outcome were analysed. Methods: Data from patients with AOG were~     analysed from a prospectively collected database with regard to surgical treatment,~     preoperative and postoperative staging, and outcome.~   "
137785|NCT01763762|"~     The purpose of this study is to determine whether electrical pudendal nerve stimulation is~     more effective than pelvic floor muscle training with Transvaginal electrical stimulation in~     treating female stress incontinence.~   "
137540|NCT01766960|"~     One-third of the U.S. population suffers from non-alcoholic fatty liver disease (NAFLD).~     NAFLD is caused by diabetes and obesity, and is becoming more common. Although many people~     have this disease, the change in how the liver handles drugs and compounds in the body has~     not been studied. The purpose of this study is to investigate how advanced NAFLD changes the~     ability of the liver to handle both endogenous and exogenous compounds.~   "
137541|NCT01766947|"~     Primary open angle glaucoma (POAG) is associated with inadequate drainage of the aqueous~     humor via the trabecular meshwork through the Schlemm's canal towards the systemic~     circulation. This may lead to an increase in IOP and may damage the optic nerve. The purpose~     of glaucoma management is to lower IOP in order to prevent progression of the optic~     neuropathy and subsequent visual loss. Firstline treatment usually includes IOP-lowering drug~     therapy. However, if IOP remains uncontrolled and/or the optic nerve damage progresses~     despite controlled IOP, surgery may be indicated. Deep sclerectomy (DS) is a non-penetrating~     surgical procedure for the treatment of open angle glaucoma that allows the enhancement of~     the aqueous outflow by removing part of the inner wall of Schlemm's canal and trabecular~     meshwork. DS was shown to achieve a good control on IOP over the long term.~      The purpose of this study is to assess the 24-hour IOP fluctuation profile recorded with~     Triggerfish in patients with POAG before and after DS.~   "
137542|NCT01766934|"~     Data collection on the safety and efficacy of Zarzio® / Filgrastim HEXAL® in adult healthy~     unrelated stem cell donors undergoing peripheral blood progenitor cell mobilization.~   "
137543|NCT01766921|"~     Evaluate Safety, Tolerability and Immune response of adjuvanted H5N1 cell culture derived~     influenza vaccine in elderly subjects~   "
137544|NCT01766908|"~     This is an experimental research study for pregnant women between 23 and 37 weeks age of~     gestation who will be having a baby sooner than term. This study is to learn if waiting 20,~     40, or 60 seconds to clamp the umbilical cord after baby delivers will improve his/her~     outcome and overall health. Benefit to the baby may come by increasing the amount of blood in~     the baby's body, reducing the need for possible transfusion later, and possible prevention of~     other complications caused by too little blood in the baby. Possible reduction of cerebral~     palsy may be realized by a longer interval for cord clamping.~   "
137545|NCT01766895|"~     The linkage between viral hepatitis and renal failure is complex. The current study aims to~     exlore the long-term prevalence of viral hepatitis among uremic patients in Taiwan~   "
137546|NCT01766882|"~     The purpose of this study to conduct a pilot, randomized trial in stable HD patients to~     evaluate the effect of gradual, step-wise reduction of post-hemodialysis target weight,~     combined with diligent dietary sodium restriction and reduction in dialysate sodium exposure~     on hydration/volume status and blood pressure (BP) control.~   "
137547|NCT01766869|"~     The investigators' goal is to develop a non-selective and non-invasive procedure to identify~     aggressive tumors and simultaneously identify their exact location in Prostate cancer~     patients undergoing radical prostatectomy by combining multiparametric MRI and machine~     learning techniques. The combination of multi-parametric MRI and machine learning (validated~     using histopathology) can lead to increased sensitivity and specificity of cancer foci in the~     prostate, and help in isolating aggressive from indolent tumors. This increased sensitivity~     and specificity may eventually lead to: a) a reduction in the number of patients that undergo~     unnecessary treatment, and b) enhance current treatment options by enabling the use of~     focused therapies. The investigators will recruit 15 patients with prostate cancer that are~     currently scheduled to undergo radical prostatectomy into the study. All patients will obtain~     an advanced MRI study prior to the radical prostatectomy. MRI scans will include a)~     high-resolution volumetric images using T1 and T2-weighted imaging, b) vascular images using~     dynamic contrast enhanced (DCE) imaging, c) biophysical microstructure images using~     diffusion-weighted imaging, and d) biochemical images using MR spectroscopic imaging.~     Following radical prostatectomy, a pathologist will grade the prostatectomy specimens based~     on standard of care (Gleason grading system). Correlations will be generated between the~     parameters obtained from scans and from clinical assessments.~   "
137548|NCT01766856|"~     This study will determine whether the likely success of closing a hole in the eardrum can be~     predicted by testing Eustachian tube function. The Eustachian tube is a natural tube that~     connects the back of the nose with the middle ear. When a person goes up in an airplane and~     their ears pop or when one yawns and their ears pop, that is the Eustachian tube opening.~     The Eustachian tube is responsible for keeping the air pressure in the middle ear the same as~     in the environment and keeping the middle ear free of fluid. It is thought that in children~     with middle-ear disease, the muscles that open the Eustachian tube do not work very well;~     this seems to get better in many children as they get older. It is thought that poor~     Eustachian tube function is the cause of failures when holes in the eardrum are patched and~     also for the recurrence of fluid in the middle-ear. The primary goal of this study is to see~     whether it can be predicted, based on testing Eustachian tube function before surgery,~     whether patching the eardrum will be successful and whether fluid will come back in the ear~     after it is patched.~   "
137549|NCT01766843|"~     The purpose of this study is to compare the test product Salmeterol/fluticasone Easyhaler~     with the reference product Seretide Diskus in terms of drug absorbed in the bloodstream.~   "
137559|NCT01766713|"~     Nonalcoholic fatty liver disease (NAFLD) represents a spectrum of diseases ranging from~     simple steatosis to nonalcoholic steatohepatitis (NASH), the progressive form of liver~     disease that can lead to cirrhosis and liver-related mortality in persons who drink little or~     no alcohol. Nonalcoholic steatohepatitis (NASH) represents the more severe end of this~     spectrum and is characterized by steatosis, ballooning degeneration and lobular inflammation~     with or without fibrosis. The etiology of NASH is not completely understood, but it is often~     associated with obesity, type 2 diabetes, hyperlipidemia and insulin resistance.~     Lipotoxicity, insulin resistance and oxidative stress appear to be central to the~     pathogenesis of NASH. Currently, there is no FDA approved treatment for NAFLD/NASH. Weight~     loss and exercise are the recommended but often difficult maintain these lifestyle changes in~     the long term and therefore therapeutic agents have been investigated. Ezetimibe is an LDL~     lowering agent that works through inhibition of the fat absorption from the small intestine.~     In this study, we propose to treat 50 patients with NASH with either Ezetimibe or placebo for~     24 weeks. After an initial evaluation for insulin sensitivity, MRI liver fat distribution and~     liver biopsy, patients will receive either 10 mg/day of Ezetimibe or placebo. Patients will~     be monitored at regular intervals for symptoms of liver disease, side effects of Ezetimibe~     and serum biochemical and metabolic indices. At the end of 24-weeks, patients will have a~     repeat medical evaluation, liver MRI and liver biopsy. Pre and post treatment MRI-derived~     liver fat content, liver histology and insulin sensitivity will be compared. The primary end~     point of successful therapy will be improvement in hepatic steatosis measured by MRI.~     Secondary end points will be improvement in insulin sensitivity, liver histology and liver~     biochemistry.~   "
137550|NCT01766830|"~     Tropical fevers have been a diagnostic challenge from the antiquity. Nowadays, despite the~     availability of good diagnostic capacities, undifferentiated febrile illnesses continue to be~     a thorny problem for travel physicians. In developing countries, the scarcity of skilled~     personnel and adequate laboratory facilities makes the differential diagnosis of fevers even~     more complex. Health care workers must often rely on syndrome-oriented empirical approaches~     to treatment and might overestimate or underestimate the likelihood of certain diseases. For~     instance Neglected Tropical Diseases (NTD) contribute substantially to the burden of~     persistent (more than 1 week) fevers in the Tropics, causing considerable mortality and major~     disability. These diseases are however rarely diagnosed at primary health care (PHC) level.~     The difficulty in establishing the cause of febrile illnesses has resulted in omission or~     delays in treatment, irrational prescriptions with polytherapy, increasing cost and~     development of drug resistance.~      In resource-limited settings, clinical algorithms constitute a valuable aid to health~     workers, as they facilitate the therapeutic decision in the absence of good laboratory~     capacities. There is a critical lack of appropriate diagnostic tools to guide treatment of~     NTDs. While clinical algorithms have been developed for some NTDs, in most cases they remain~     empirical. Besides, they rarely take into account local prevalence data, do not adequately~     represent the spectrum of patients and differential diagnosis at the primary care level and~     often have not been properly validated. The purpose of the study is to develop evidence-based~     Rapid Diagnostic Test (RDT)-supported diagnostic guidelines for patients with persistent~     fever (≥ 1 week) in the Democratic Republic of the Congo (DRC), Sudan, Cambodia and Nepal.~   "
137551|NCT01766817|"~     The purpose of this study is to determine if study drug (BMS-986020) dose of 600 mg once~     daily or 600 mg twice daily for 26 weeks compared with placebo will reduce the decline in~     forced vital capacity (FVC) and will be well tolerated in subjects with idiopathic pulmonary~     fibrosis (IPF).~   "
137552|NCT01766804|"~     The aim of the present study is to evaluate the ability a colostrum containing diet to limit~     gastrointestinal toxicity including chemotherapy induced inflammation in children treated for~     acute lymphoblastic leukemia.~   "
137553|NCT01766791|"~     A plethora of trials reported the positive effect of resistance exercise on functional and~     morphological parameters. Although a large amount of the studies used suboptimum devices and~     obsolete methods the results of these older studies were still considered as golden standard.~     The aim of the present study is thus to determine the proper effect of different resistance~     exercise protocols with and without adjuvant protein supplementation on functional and~     morphological muscle and body composition parameters in male untrained subjects 30-50 years~     old under special regard of modern medical imaging and segmentation technologies.~      Our general study hypothesis is that HIT-resistance exercise significantly impact relevant~     muscular parameters of the upper leg.~   "
137554|NCT01766778|"~     The purpose of this study was to observe change of HbA1c over time from baseline to month 12.~     The ultimate goal of this study was to provide a local reference value to the physicians &~     patients in the future when they consider initiating Vildagliptin and taking balance between~     efficacy, compliance, risk factors, convenience and medication cost.~   "
137555|NCT01766765|"~     Adjuvant chemotherapy (AC) for gastric cancer is known to improve prognosis, and longer time~     to AC is associated with worse survival. However, most clinical trials mandate that AC is~     still to commence within 6 to 8 weeks after surgery consideration for malnutrition,~     postoperative complications and intolerance of AC. Placement of jejunostomy nutrition tube~     for enteral nutrition is a common component of these procedures, as a result of superior~     postoperative organ function, decreased infection rates, and a greater likelihood to complete~     AC with enteral nutritional support.~      Fast-track surgery (FTS) recovery program focuses on enhancing recovery and reducing~     morbidity. Introduction of FTS concepts are safe, feasible, and can achieve shorter hospital~     stays and reduced costs. Early postoperative enteral nutrition combined with FTS results in~     reductions in total complications compared with traditional postoperative feeding practices~     and does not negatively affect outcomes. However, the benefit of jejunostomy nutrition tube~     routine placement and combination with FTS is still being debated. Besides, there remains~     some controversy over the optimal combination of nutrients and duration and timing and routes~     of feed administration.~      The aim of this study was to determine whether FTS with early jejunostomy nutrition (EJN)~     following laparoscopic gastrectomy for gastric cancer improved postoperative recovery and~     minimizes time to AC when compared with FTS with early oral nutrition (EON).~   "
137556|NCT01766752|"~     Objective: To investigate the performance (safety) of the GlucoTab system for glycaemic~     management in non-critically ill patients with type 2 diabetes at the general ward~   "
137557|NCT01766739|"~     The purpose of this study is to test the safety of the GL-ONC1 vaccinia virus at different~     dose levels. The investigators want to find out what effects, good and/or bad, it has on the~     patient and the malignant pleural effusion. A malignant pleural effusion is a build up of~     fluid in the chest cavity cause by the cancer.~   "
137558|NCT01766726|"~     The main aims of this study are to determine whether: a) ART-naïve HIV+ subjects have~     increased artherosclerotic plaque inflammation/vulnerability, b) newly-initiated~     QUAD/Stribild therapy will decrease plaque inflammation/vulnerability in these subjects, and~     c) QUAD/Stribild therapy will improve indices of immune dysregulation and lipid dysfunction~     as a mechanism of improved plaque inflammation/vulnerability. Parameters of lipid and immune~     function will also be assessed in healthy control subjects, for comparison.~   "
137560|NCT01766700|"~     The no calorie drink study is looking for over 300 people to participate. The study is~     evaluating the effect of no calorie beverages on weight loss and weight maintained over time~     in people who drink diet beverages every day as compared to water only drinkers during the 1~     year study period.~   "
137561|NCT01766687|"~     The investigators have designed a randomized controlled trial to test whether increased water~     intake slows renal decline in patients with Stage-III Chronic Kidney Disease. Participants~     randomized to the hydration-intervention group will be asked to drink 1.0 to 1.5 L of water~     per day (depending on sex and weight), in addition to usual fluid intake, for one year. The~     investigators will calculate the change in kidney function (estimated glomerular filtration~     rate, measured every three months for 12 months), and compare renal decline between the~     intervention and control groups. The investigators hypothesize that increased water intake~     will slow renal decline.~   "
137563|NCT01766661|"~     The aim of this study is to decrease the morbidity by 30% using the Turnbull-Cutait procedure~     in comparison to the standard surgery for low rectal cancer. The investigators compare~     quality of life, faecal incontinence and recurrence of neoplasm in patients who received~     standard colo-anal anastomosis with protective ileostomy or two-staged Turnbull-Cutait~     colo-anal anastomosis after Low Anterior Resection for rectal cancer.~   "
137564|NCT01766648|"~     To determine if Far Cortical Locking screws increase fracture healing rates at 3 months in~     Closed Distal Femur Fractures in adults when compared to standard locking screw constructs.~      Fracture healing at 3 months will be assessed via x-ray and clinical assessment of the~     fracture.~      Null Hypothesis: There will be no difference in fracture healing at 3 months post-fixation~     between subjects treated with far cortical locking screw or standard locking screw fixation.~   "
137565|NCT01766622|"~     Background:~      - 18F-CP18 is a chemical designed for use in imaging studies. It is attracted to tumor cells~     that are being killed by cancer treatment. Researchers want to test it in imaging studies for~     people who are being treated with Birinapant. Birinapant is a drug used to treat advanced~     ovarian, fallopian tube, or peritoneal cancers. It works kills tumor cells that have not~     responded to earlier treatment. 18F-CP18 may help to monitor cancer treatments with this~     drug.~      Objectives:~      - To test the effectiveness of 18F-CP18 imaging studies during cancer treatment with~     Birinapant.~      Eligibility:~      - Individuals at least 18 years of age who are taking Birinapant for ovarian, fallopian tube,~     or peritoneal cancer.~      Design:~        -  Participants will have a brief physical exam. They will also answer questions about~          their medical history and any current medications.~        -  Participants will receive a dose of 18F-CP18, followed by an imaging study. The study~          will involve a positron emission tomography/computed tomography (PET/CT) scan. The scan~          will last 40 minutes.~        -  There will be two more PET/CT scans 1 hour and 2 hours after taking 18F-CP18. These~          scans will look at how the tumor cells absorb and process 18F-CP18.~        -  This is a scanning study only. No treatment will be provided as part of this study.~   "
137566|NCT01766609|"~     Vitiligo is a chronic acquired disease characterized by well defined white macules and~     patches affecting the skin. It has a major psychosocial impact on affected patients. There~     are many treatment modalities available for vitiligo, however, none of them cure the disease.~     Topical corticosteroids (CS) are the most effective monotherapy for localized vitiligo.~     Treatment with intralesional corticosteroids (ILCS) is commonly used in many dermatologic~     conditions. However, there are only a few studies published on the use of ILCS in vitiligo.~     This is a prospective double-blind randomized clinical trial to assess efficacy and safety of~     ILCS in the treatment of vitiligo. Four treatment sessions will be done over 4 to 6 months.~     The investigators will compare intralesional triamcinolone acetonide (active treatment) to~     normal saline (placebo).~   "
137567|NCT01766596|"~     The aim of the study proposed in Dijon is above all to focus on the possible relationship~     between age-related ocular pathologies (AMD and glaucoma) and et les degenerative~     neurological and cardiac pathologies.~      The principal objective is to seek in subjects who have undergone cerebral MRI and~     echocardiography, associations between the thickness of postganglionic fibers measured by~     Optical Coherence Tomography at the 7th year (n=1500) and signs of cerebral impairment~     (psycho-cognitive tests, circulation time, MRI signs). This association will be studied after~     taking into account the principal environmental (particularly dietary) and genetic risk~     factors.~   "
137568|NCT01766583|"~     This is an open label, 3 + 3 dose escalation study, to determine the MTD, safety, efficacy~     and PK profiles for subjects with relapsed/refractory B-cell malignancies when using CC-292~     and lenalidomide combination therapy. Subjects will be followed for disease progression and~     collection of second primary malignancy (SPM) events. This dose escalation will be followed~     by an exploratory expansion phase in 3 cohorts of 12 patients each.~   "
137569|NCT01766570|"~     The purpose of this study is to measure the beneficial effects of an optimized berries~     extracts on diabetes and cardiovascular diseases prevention. Our hypothesis is that including~     a polyphenol rich berries extract in daily feeding will improve insulin sensitivity, glucose~     tolerance, pancreatic β-cells function, lipids and inflammatory profile, and oxidative stress~     markers.~   "
137570|NCT01766557|"~     The objective of our study is to determine the effects of fish protein on insulin sensitivity~     in PCOS women with insulin resistance, and its mechanism of action on glucose and endocrine~     metabolism. Our working hypothesis is that dietary fish protein improves insulin sensitivity,~     glucose tolerance, and related plasma endocrine and lipid abnormalities in PCOS women by~     restoring secretory β-cell function and insulin signaling to the PI 3-kinase activity/Akt~     pathway. We further hypothesize that fish protein will improve cycle regularity and ovarian~     function.~   "
137571|NCT01766544|"~     This is a report of a protocol developed to improve asthma and COPD care in a primary care~     setting. The study was approved by an Ethics Committee and support by the Canadian Thoracic~     Society through an unrestrictive grant from GlaxoSmithKline. However, the study could not be~     done and the investigators report why, discussing the difficulties to perform such study.~     This information should be very useful to investigators planning this sort of study.~   "
137572|NCT01766531|"~     Prospective cohort, monocentric non-randomized and interventional clinical study in ICU~     assessing the evolution of body composition using bioelectrical impedance analysis.~   "
137573|NCT01766518|"~     Efficacy and safety of MY-REPT capsule in primary, liver transplantation recipients~   "
137574|NCT01766505|"~     The purpose of this study is to compare efficacy and safety of candesartan and losartan in~     hypertension with heart failure.~   "
137575|NCT01766492|"~     Quality of life data following SBRT for prostate cancer has been obtained in only a small~     numbers of patients. A prospective study using validated quality of life questionnaires is~     needed to determine outcomes after treatment with SBRT. Our study will be the first essential~     step in developing a better evidence base on the comparative risks and benefits of SBRT~     treatment with regards to quality of life assessment and outcomes.~   "
137590|NCT01766297|"~     The purpose of this research study is to compare the effects (good and bad) on women and~     their cancer using proton radiation therapy.~      This study is being done to see if proton radiation therapy will prove to be beneficial for~     women with early stage breast cancer. A clinical study is necessary to compare the results~     (good or bad) of proton radiation therapy.~   "
137576|NCT01766479|"~     Background: Although subjects with first-degree relatives (FDR) with a history of colorectal~     cancer (CRC) are at increased risk for CRC, compliance to screening colonoscopy is~     suboptimal. Computed tomographic colonography (CTC) has been recognized as an alternative for~     CRC screening in average risk subjects, but less information is available on its performance~     in FDRs.~      Aims: To prospectively assess the accuracy of CTC as a screening tool in FDRs using~     colonoscopy (OC) with segmental unblinding as reference standard.~      Methods: Consecutive patients admitted with CRC diagnosis (index case, IC) were prospectively~     evaluated. Following the systematic identification of ICs with inherited predispositions to~     CRC, ICs who agreed to contact their FDRs ≥40 years old were included. Available FDRs were~     invited to undergo non-cathartic CTC, with OC the following day.~     Sensitivity/specificity/PPV/NPV of CTC was assessed for detecting subjects with any lesion ≥6~     mm, ≥10 mm, and for advanced neoplasia ≥6 mm.~   "
137577|NCT01766466|"~     To demonstrate that patients treated with cangrelor can be directly switched to oral~     ticagrelor and that patients treated with ticagrelor can be switched to cangrelor without a~     significant decrease in the extent of inhibition of platelet aggregation.~   "
137578|NCT01766453|"~     South Asians have one of the highest rates of heart disease of all populations and a unique~     and deleterious obesity phenotype of increased body fat and inner-abdominal compared to those~     of European background. We have subsequently identified that this unique phenotype accounts~     for much of the increased heart disease risk in South Asians, with the greater amounts of~     inner abdominal fat being particularly implicated. In addition, South Asians in Canada have~     substantially lower levels of leisure-time physical activity.~      At present, we do not know the answers to the following questions:~        1. Is a conventional (standard) physical activity program that has proven effective at~          reducing inner abdominal fat and heart disease risk factors in populations of European~          background be effective in South Asians?~        2. Is an alternative physical activity program commonly practiced by South Asians (such as~          bhangra dance) be effective at reducing inner abdominal fat and heart disease risk~          factors in South Asians? In this study, we will perform a randomized controlled trial of~          three conditions—gym-based standard exercise program (SE),bhangra dance exercise program~          (BE) and non-exercise control (NE).We will recruit 75 post-menopausal South Asian women~          with abdominal obesity and assign them randomly to one of the three groups (25 per~          group).~      We anticipate that both the SE and BE programs will be superior to the NE group in terms of~     reducing VAT and CVD risk factors. Such findings will demonstrate that exercise is an~     effective method that favourably modifies the obesity phenotype of excess VAT in South~     Asians, and should be central to health promotion and disease prevention strategies.~   "
137579|NCT01766440|"~     The purpose of this study is to determine if the calcitriol absorption in pediatric subjects~     is comparable to that in adults and adolescents, with no significant impact on~     calcium/phosphorus metabolism.~   "
137580|NCT01766427|"~     1. To observe the Efficiency of Electroacupuncture for Hypertension Patients With Chronic~          Kidney Disease.~        2. To observe if different-time treatment having an impact on Hypertension Patients With~          Chronic Kidney Disease.~   "
137581|NCT01766414|"~     Excessive inflammation is associated with tissue damage caused by over-activation of the~     innate immune system. This can range from mild disease to extreme conditions, such as~     multiple organ dysfunction syndrome (MODS) and acute respiratory distress (ARDS). In marked~     contrast to adaptive immunity which is very sensitive to immune modulators such as steroids,~     the innate immune system cannot be sufficiently targeted by currently available~     anti-inflammatory drugs.~      The investigators hypothesize that pre-treatment with C1-esterase inhibitor in a human~     endotoxemia model can modulate the innate immune response.~      In this study, human endotoxemia will be used as a model for inflammation. Subjects will,~     prior to endotoxin administration, receive C1 esterase inhibitor or placebo. Blood will be~     sampled to determine the levels of markers of the innate immune response.~   "
137582|NCT01766401|"~     The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone~     relative to placebo in the treatment of generalized anxiety disorder (GAD).~   "
137583|NCT01766388|"~     The primary goal of this study is to examine the efficacy and feasibility of a mifepristone~     combined with misoprostol medical abortion regimen in terminating pregnancies 13-22 weeks in~     Armenia.~   "
137584|NCT01766375|"~     This study was a multi-center, open, randomized-control study on the effects and safety of~     idarubicin 60mg/M2 combined with BUCY pretreatment program or BUCY pretreatment program on~     the overall survival rate and disease-free survival rate of acute myeloid leukemia patient in~     high-risk group over a period of 2 years.~   "
137585|NCT01766362|"~     The aim of this study is to show that PRPC performed in a single session using a Pascal laser~     leads to better management of the disease (better rate of regression of neovessels, lower~     risk of a loss of visual acuity in the long term related to macular edema), a saving of time~     and better comfort for both patient and doctor.~   "
137586|NCT01766349|"~     The purposes of this study are to investigate in patients with newly diagnosed esophageal~     cancer: 1)changes in pulmonary and respiratory muscle function, functional capacity and~     quality of life during and after RT or CCRT treatment; 2)the correlations between these~     changes; and 3)the impacts of these changes on the postoperative pulmonary complications~     following esophagectomy.~   "
137587|NCT01766336|"~     To evaluate the safety and tolerability of ELND005 treatment with up to 36 weeks exposure, in~     Moderate to Severe AD patients with agitation and aggression.~   "
137588|NCT01766323|"~     Oral morphine is often utilized as a convenient and effective method of achieving palliation~     of pain in the terminally ill cancer patients. However, at effective doses, a majority of~     patients do experience an undue amount of excessive sleepiness. Given the generally low~     expected survival periods among this patient population, the fact that morphine causes the~     patient to spend a significant period of remaining life in sleep, is often unacceptable for~     the patients and their families. Given the proven benefits of modafinil in conditions~     characterized by excessive sleepiness (such as with narcolepsy and shift-work disorder), the~     investigators designed a prospective placebo controlled randomized trial by the addition of~     modafinil at a dose of 200mg per day (in two divided doses) for eligible patients after~     randomization.~   "
137786|NCT01763749|"~     The Aim of this study is to prove non-inferiority of Closone to the Combination treatment of~     Plavix with Astrix.~   "
137591|NCT01766284|"~     Optical Coherence Tomography (OCT) is a technology using harmless near infra-red light~     scatter to produce an image. Prior studies with OCT have demonstrated that OCT of the uterine~     cervix can differentiate between grades of pre-invasive and invasive cervical disease and~     cancer. This study will evaluate the ability of the NIRIS 1300e imaging (OCT) system to~     detect pre-invasive cervical disease and cervical cancer.~   "
137592|NCT01766271|"~     The purpose of this 4 group (2x2) pilot randomized controlled trial is to test the~     feasibility and logistics of incorporating genetic risk information (9p21)into standard~     Coronary Heart Disease (CHD) risk counseling or health coaching intervention (or both) in~     primary care at 2 Duke Clinics.~   "
137593|NCT01766258|"~     The primary objective of the study is to assess the efficacy, carbidopa dose response and~     safety of ODM-101, a new combination of levodopa, carbidopa and entacapone in the treatment~     of Parkinson's disease (PD) patients with end-of-dose motor fluctuations.~   "
137594|NCT01766245|"~     This trial is conducted in Europe. The aim of the trial is to investigate the bioequivalence~     (assessment of the expected biological equivalence of two pharmaceutical drug products with~     identical active ingredient) between subcutaneous injections of semaglutide produced by two~     manufacturing processes.~   "
137595|NCT01766232|"~     Epiphora, or uncontrolled tearing of the eyes, represents a common presenting complaint of~     patients seen by ophthalmologists. Epiphora may be due to non-obstructive causes, such as~     tear hypersecretion or functional tear pump failure, or obstructive causes. Functional tear~     pump failure may result from malposition of the eyelids, such as an abnormal out-turning~     (ectropion) or in-turning (entropion) of the eyelid.~      Currently methods to diagnose partial nasolacrimal duct obstruction are purely qualitative in~     nature. Our research goal is to quantitatively measure the pressure generated during~     conventional probing and irrigation (P&I), and to measure the resistance to irrigation of the~     nasolacrimal drainage system.~      The investigators will measure the pressure generated during conventional P&I using a~     disposable in-line pressure transducer. In addition, the investigators will use a syringe~     pump to deliver a constant flow rate of saline through a nasolacrimal cannula and measure the~     steady state irrigation pressure using the in-line transducer and digital pressure monitor.~     Resistance can be directly calculated from the known flow rate and pressure measurements.~      The investigators will compare both the pressure generated during P&I and the lacrimal~     drainage resistance between patients with lacrimal drainage obstruction and controls patients~     with no obstruction (functional tear pump failure) as determined by clinical exam.~      Clinical applications for measuring lacrimal drainage resistance include quantifying partial~     nasolacrimal duct obstruction, guiding the choice of surgical procedure, and determining the~     success of lacrimal drainage procedures.~   "
137596|NCT01766219|"~     This pilot clinical trial studies 6,8-bis(benzylthio)octanoic acid in treating patients with~     advanced or metastatic cholangiocarcinoma that cannot be removed by surgery.~     6,8-Bis(benzylthio)octanoic acid may stop the growth of cholangiocarcinoma by blocking blood~     flow to the tumor~   "
137597|NCT01766206|"~     A multicenter, single arm, post-marketing surveillance study. This study is a postlicensure~     requirement of the Korea Food and Drug Administration (KFDA) to provide continued safety~     evaluation of MenACWY in the Korean population from 2 months to 55 years of age, receiving~     MenACWY-CRM vaccination according to routine clinical practice and prescribing information.~   "
137598|NCT01766193|"~     The lifetime risk for a woman to undergo surgery for either vaginal prolapse or urinary~     incontinence is high. Previous studies have shown that pregnancy and childbirth are risk~     factors for developing prolapse. There is a lack of studies that follow women several years~     after delivery aiming to find whether symptoms of prolapse are linked to delivery method, ie~     vacuum, forceps, normal vaginal delivery and cesarean section. The investigators plan this~     study is to get more knowledge about pathology of prolapse and incontinence, to enable~     development of preventive strategies for these conditions.~      Aim of the study is to determine whether the prevalence of symptoms and performed surgery for~     urogenital prolapse differs among women delivered by vacuum, forceps, normal vaginal delivery~     and cesarean section 15-20 years after their first delivery.~      The investigators identify women that delivered their first child at St. Olavs Hospital,~     Trondheim, Norway between 1990-1997. Questionnaires will be sent to 2500 women (PFIQ-7,~     PFDI-20, PISQ-12), 600 of whom will get a clinical examination, where pelvic floor~     musculature is examined by palpation and 4D ultrasound, and a POP-Q quantification of~     prolapse performed.~   "
137599|NCT01766180|"~     The purpose of this study is to determine whether Fruitflow-II, Resveratrol (resVida), alone~     or in combination, are effective in the treatment of memory problems in adult patients with~     memory impairment. We also evaluate effects of these medications on blood flow to the brain~     and fitness, to find whether the possible improvement in memory is associated with the~     alterations in these parameters.~   "
137600|NCT01766167|"~     To conduct the following evaluations in Korean healthy male adult volunteers receiving a~     single and multiple doses of MP-424 tablets:~        -  Pharmacokinetics of MP-424 after a single and multiple doses.~        -  Safety and tolerability of single and multiple doses of MP-424.~   "
137601|NCT01766154|"~     The purpose of this study is to evaluate tirofiban concentration in the blood over a period~     of 24 hours after tirofiban administration. Subjects with varying degrees of renal~     insufficiency (i.e. kidney function) will be included in the study. Tirofiban is known to be~     cleared from the blood by the kidneys and so people with kidney problems clear tirofiban to a~     slower extent compared to people without kidney problems. By comparing the tirofiban~     concentration profile between subjects with healthy kidney function versus with impaired~     kidney function, a tirofiban dosing recommendation for subjects with impaired kidney function~     can be made.~      This is a non-randomized, single-center, open-label study. A single dose of tirofiban (25~     µg/kg administered intravenously over a 3 min period) will be administered to subjects with~     normal renal function (>90 mL/min CrCl), moderate (30-59 mL/min CrCl), and severe (<30 mL/min~     CrCl) renal impairment with non-dialysis-dependent renal insufficiency~   "
137614|NCT01765985|"~     Interferential current has shown promising results for treating psoriasis with a good~     tolerance. Prospective randomized studies versus placebo are required to confirm the interest~     of such an approach.~      The Main objective is to assess the efficacy of interferential current for treating~     palmoplantar psoriasis.~      Secondary objectives is to assess the subjective efficacy by the patients, the efficacy on~     the nails, to study the potential side effects.~   "
137602|NCT01766141|"~     It is expected that mechanical low back pain (LBP) is associated with inflammatory changes~     localized to the affected tissues. Could such changes be detected in cells involved in the~     inflammatory process in an in vitro model? The investigators wish to test such a model to~     compare inflammatory markers in acute and chronic LBP patients and also examine the effect of~     spinal manipulative treatment (SMT) on changing the level of selected key inflammatory~     markers. The investigators hypothesize that:~        1. Proinflammatory markers will be elevated while antinflammatory markers will be reduced~          in acute LBP patients relative to chronic back pain patients as well as in healthy study~          participants who have no LBP or any inflammatory conditions (controls).~        2. SMT will cause a reduction in the production of proinflammatory markers while~          anti-inflammatory markers will increase relative to baseline levels as well as relative~          to controls~   "
137603|NCT01766128|"~     The aim of this study is investigation of neuroprotective effect of zonisamide in early~     Parkinson disease. A total of 60 patients with early Parkinson disease who meet the study~     criteria will be enrolled and randomized into two groups alternately based on their visit~     date. Demographic data, Unified Parkinson's Disease Rating Scale (UPDRS), modified Hoehn&Yahr~     and modified Schwab&England activities of daily living scale will be determined and~     registered for each patient. Patients of group A will be treated by zonisamide 50mg/d for 12~     months and the other group will be treated by placebo for the same time. Primary endpoint is~     occurrence of parkinsonian symptoms which interfere with patients' daily activity or cause~     psychosocial embarrassment. The mentioned scores will be registered every 2 months for both~     groups by blinded neurologist and also regular blood test will be performed to prevent drug~     adverse events.~   "
137604|NCT01766115|"~     To assess the safety and tolerability of the use of telaprevir in the setting of~     post-exposure prophylaxis among HCW exposed to HCV genotype 1 or genotype 2.~      To assess the election rate of postexposure prophylaxis for HCV-related occupational~     exposures in HCW.~   "
137605|NCT01766102|"~     A breast biopsy in the operating room may be needed in up to 15% of patients with an~     abnormality on mammogram. When an abnormality is present but there is no palpable mass, the~     abnormality must be localized with a wire before going to the operating room. This technique~     is also used when a breast cancer is present but there is no mass, in order to perform a~     targeted lumpectomy. Once the abnormality is surgically removed, the specimen with the wire~     is taken to the breast imaging department for a specimen x-ray to ensure that the targeted~     abnormality is present within the specimen. If the abnormality is close to the edge of the~     specimen, additional tissue is often removed.~      A newer method for evaluating the specimen is to perform imaging in the operating room.~     Portable digital mammography units are available for this purpose. The Biovision digital~     specimen mammography system is FDA-approved and currently in use in over 200 centers in the~     United States. Several studies have shown that intra-operative digital mammography is as~     accurate as standard specimen mammography and takes less time to perform. It may also~     decrease the chance of having to go back to the operating room to take more breast tissue~     after lumpectomy because of cancer cells near teh margin(s) of the specimen on final~     pathology. Having to go back to the operating room to take more tissue is called a~     re-excision.~      The purpose of this study is to compare standard specimen mammography to intra-operative~     specimen mammography to quantify potential operating room time savings and to determine if~     the use of intra-operative specimen mammography decreases re-excision rates. We aim to see if~     intra-operative specimen mammography is more efficient and if it decreases re-excision rates.~   "
137606|NCT01766089|"~     Preeclampsia is a pregnancy-specific, multisystem disorder that complicates approximately 5 %~     of pregnancies.~      Tracheal intubation in the women with severe pre-eclampsia is usually associated with~     exaggerated transient increases in blood pressure, heart rate and maternal plasma~     catecholamine concentrations. These changes may lead to maternal cerebral oedema,~     haemorrhage, left ventricular failure, pulmonary oedema or mortality, and reduce uterine~     blood flow which may adversely affect the neonatal wellbeing. Therefore, the attenuation of~     the haemodynamic responses to tracheal intubation in this unique group of patients is~     demanding for the best of both mother and foetus.~      The use of single remifentanil boluses of 0.5 to 1 µg/kg reduces effectively the haemodynamic~     and catecholamine responses to laryngoscopy and tracheal intubation in severe pre-eclamptics~     during Cesarean delivery under general anesthesia. Unfortunately, the use of 1 µg/kg doses~     are associated with more maternal hypotension and neonatal respiratory depression requiring~     resuscitation. Moreover, the use of preinduction remifentanil bolus of 0.5 µg/kg followed by~     a continuous infusion at 0.15-0.2 µg/kg/min is associated with significant attenuation of the~     maternal stress response to tracheal intubation with variable degree of neonatal depression~     in non-pre-eclamptic women. Whereas, the use of infusion rates of 0.1 µg/kg/min or less is~     less likely to produce neonatal depression.~      In our previous study, we demonstrated that the preoperative administration of~     dexmedetomidine 0.4 and 0.6 µg/kg/h, a specific alpha 2-adrenoceptor agonist, blunts the~     maternal haemodynamic and hormonal responses to Caesarean delivery under sevoflurane~     anaesthesia without adverse neonatal effects. However the use of 0.6 µg/kg/h doses is~     associated with higher postoperative sedation scores.~   "
137607|NCT01766076|"~     We hypothesise that atorvastatin changes immune activation among HAART-treated adults with~     suboptimal cluster cell differentiation 4 (CD4) recovery by 25%~   "
137608|NCT01766063|"~     The study aims to investigate the relationship between sleep quality, quality of life,other~     disorders and therapies in Multiple Sclerosis (MS) patients treated with Betaferon.~   "
137609|NCT01766050|"~     The purpose of this study is to determine the effects of belatacept on the pharmacokinetics~     of caffeine, losartan, omeprazole, dextromethorphan and midazolam~   "
137610|NCT01766037|"~     This research study is being performed to find out if a new device, AspireAssist Aspiration~     Therapy System, can help people with obesity to lose weight without causing too many side~     effects.~   "
137611|NCT01766024|"~     This is a randomized double-blind crossover study of pharmacokinetics, pharmacodynamics and~     tolerability of BCD-033 (interferon beta-1a manufactured by CJSC BIOCAD, Russia) and Rebif®~     (Merck Serono S.p.A.., Italy) in healthy volunteers. The purpose of the study is to~     demonstrate the non-inferiority of pharmacokinetics, pharmacodynamics and tolerability~     parameters after single subcutaneous injection. Each dtug will be administered to each~     volunteer at a dose of 44 µg as a single subcutaneous injection with an interval of at least~     14 days.~   "
137612|NCT01766011|"~     The purpose of this study is to assess overall growth of preterm infants fed a reformulated~     preterm infant formula during hospitalization. All study products meet levels of nutrients~     for the infant population as specified in the Infant Formula Act and all subsequent~     amendments.~   "
137613|NCT01765998|"~     Inflammatory Bowel Disease (IBD) is an immune mediated chronic intestinal condition. It~     includes ulcerative colitis (UC) and Crohn's disease(CD). probiotics have been shown to be~     effective in varried clinical conditions ranging fron infantile diarrhea, necrotizing~     enterocolitis,helicobacter pylori infections, etc.~   "
137616|NCT01765959|"~     Auricular acupuncture and cognitive behavioral therapy in the context of insomnia and low~     dose dependence of benzodiazepine-like drugs and other sleep medicine with addiction risk~      INTRODUCTION: Insomnia is a common health problem in Sweden, which increases with age and is~     more prevalent among women.~      It is defined by unsatisfied sleep quality during more than a month's time. The main symptoms~     are difficulties falling- and/or maintaining sleep, involuntary awakenings during the night~     of early morning, day time sleepiness and decreased will for day time activity due to~     sleepiness. Insomnia is ranked to be the fifth most common cause of prescription of medicine~     at the outpatient clinics in general health care in Sweden. In 2008 a prevalence study was~     initiated in Sweden by the Swedish Council on Health Technology Assessment (SBU). The study~     showed that 24% of the Swedish population suffered from sleep disorders. Sleeping disorders~     can go on for many years and can therefore entail significant personal suffering.~      Usually sleep medicine combined with general sleeping advices is the first-hand treatment for~     insomnia. However, according to SBU, first treatment should be non-pharmacological, for~     instance cognitive behavioral therapy (CBT). Despite this recommendation the prescribing of~     sleep medicine is still high.~      There are studies that suggest auricular acupuncture (AA) to be an effective method to treat~     insomnia. However more evidence is needed to draw firm conclusions.~      AIM: The aim of the study is to investigate if AA is as effective as CBT to treat insomnia~     for patients who have stopped using benzodiazepine-like sleep medicine.~      METHOD: This is a randomized controlled study (RTC) including patients suffering from~     insomnia, with a low dose dependence of benzodiazepine-like drugs. The patients will be~     recruited from primary care and from an out-patient clinic specialized in sleeping disorders~     and also by add in the local news paper. The respondents will be randomized to one of two~     groups; group I will receive AA twice a week for 4 weeks; group II will receive CBT once a~     week for six weeks. After three months there will be a long-time follow up in order to~     investigate a potential long-term effect.~   "
137617|NCT01765946|"~     Pre-diabetes, a condition characterized by hyperglycaemia, is associated with increased~     cardiovascular risk and reduced life expectancy, as compared to the general population.~     AMP-activated protein kinase (AMPK) is an enzyme that plays a key role in cellular energy~     homeostasis and metabolism, and recently it has been demonstrated that AMPK regulates aging~     pathways, as well. AMPK is susceptible to modulation through pharmacologic (e.g. metformin)~     and non-pharmacologic (e.g. physical exercise) interventions. This clinical trial aims to~     describe the effects of the AMPK pathway on longevity genes and inflammation in the setting~     of pre-diabetes in vivo and in vitro. To this end, the investigators will compare treatment~     with metformin (500 mg t.i.d) for 2 months, versus placebo in pre-diabetic subjects. The~     investigators will assess expression of longevity genes SIRT1, p66Shc, p53 and mTOR in~     peripheral blood mononuclear cells (PBMCs) ex vivo. The investigators will evaluate monocyte~     polarization by flow cytometry, according to the expression of surface antigens (CD68, CCR2,~     CD163, CD206, CX3CR1) to determine the prevalence of pro- or anti-inflammatory cells.~     Inflammatory cytokines (TNF-alpha, MCP-1, IL-1, IL-6, IL-10, CCL12) will also be determined.~     In the in vitro study the investigators will evaluate the effects of AMPK activation or~     inhibition on longevity gene and protein expression.~   "
137618|NCT01765933|"~     1,3-dimethylamylamine (DMAA) has become increasingly popular as a component of dietary~     supplements. It is also used within party pills, often in conjunction with alcohol and~     other drugs, and has been associated with untoward effects when abused at high dosages. To~     our knowledge, no studies have been conducted to determine the combined pharmacokinetic~     profile and physiologic responses of DMAA. To conclude on the safety profile of DMAA based~     solely on case reports would be problematic, in particular when accepting testimony from~     patients in uncontrolled environment, potentially under the influence of alcohol and other~     drugs. This is especially true in light of the fact that no prospective studies have shown~     these effects. Hence, the intent of the present study was to determine the pharmacokinetic~     profile of a single 25mg oral dosage of DMAA alone through 24 hours post-ingestion. This~     represents a typical dosage within one serving of many popular dietary supplements containing~     DMAA.~   "
137619|NCT01765920|"~     The purpose of this study is:~        -  to assess safety of the liquid dosage form of Ergoferon for treatment of acute upper~          respiratory tract infections in adult patients.~        -  to assess clinical efficacy of the liquid dosage form of Ergoferon for treatment of~          acute upper respiratory tract infections in adult patients.~   "
137620|NCT01765907|"~     Antalgic treatment of painful bone metastases by US-guided High Intensity Focused Ultrasound~     (HIFU).~   "
137621|NCT01765894|"~     Project description~      Research project title:~      Influence of moderate exercise on blood glucose in type 2 diabetics and healthy controls.~      Project description and objective~      Obesity is so widespread in Denmark that 47% of the population is classed as overweight~     (BMI>=25) and around 13% of the population is classed as obese (BMI>=30).~      The strong correlation between obesity and type 2 diabetes (at least 2/3 of type 2 diabetics~     are overweight) has led to many studies which look at different forms of exercise for this~     group, because weight loss may improve the diabetes and even defer the onset of the disorder~     and in doing so lower complications and increase long term survival.~      For people who do not have type 2 diabetes, the work-induced increased sympathetic activity~     will lead to suppressed insulin secretion and increased glucagon secretion. This increases~     the endogenous glucose production from the liver and thus maintains a normal concentration of~     blood sugar in a physical training situation where the demand for glucose has increased.~      The theory behind the project is that the mechanisms that help to increase glucose production~     in the liver during physical activity are weaker in type 2 diabetics, which can cause~     hypoglycaemia during and after physical exercise. In other words, we want to study the~     liver's sensitivity to stimulus from physical work by patients with type 2 diabetes and in~     relevant healthy control subjects.~      Previous studies have indicated that this type of mechanism is not intact in type 2~     diabetics; because the level of insulin does not fall as expected during or after physical~     training. However, there are no existing studies that measure the liver's glucose secretion~     using stable isotopes during prolonged moderate physical work. Measuring this will help to~     clarify our understanding of glucose homeostasis in type 2 diabetics.~      This study is very relevant, because it may be expected that the preferred form of physical~     exercise of an overweight type 2 diabetic can be of moderate intensity and previous studies~     also show that this form of physical exercise delivers health gains in terms of an~     improvement in insulin sensitivity and a reduction in the level of insulin.~      The objective of this study is to determine if the level of blood glucose stays constant~     before, during and after physical training and to examine the liver's ability to secret~     glucose accordingly.~   "
137622|NCT01765881|"~     For about 10% of pregnancies, it is necessary to induce delivery for medical reasons.~     Prostaglandins alone can be used to perform cervical ripening in cases of immature cervix. In~     France, dinoprostone is the own approved medication. It is in the form of gel or sustained~     release device whose effectiveness and side effects are comparable. The vaginal misoprostol~     has no marketing authorization in France, but is sometimes used. Some data in the scientific~     literature have showed that its use with low-dose (25 mcg) vaginally did not lead to more~     complications, was at least as effective and seems to be cost-effective compared with~     dinoprostone. Misoprostol with this dose and route of administration is now recommended by~     the American College of Obstetricians and Gynecologist (ACOG), Grade A (ACOG Practice~     Bulletin August 2009). This is not the case in France (French HAS 2008 Guidelines on~     induction of labor). According to HAS, the investigators still lack data on large samples to~     confirm the benefits of misoprostol 25 mcg vaginally, in terms of efficiency, rate of~     cesarean section, and lower cost compared to dinoprostone.~      The primary objective is to demonstrate non-inferiority of vaginal misoprostol 25 mcg vs.~     dinoprostone in terms of cesarian section occurence with a non-inferiority margin of +5%~     difference.~   "
137623|NCT01765868|"~     This is a open label, single center, single oral dose, study of PRT054021, in healthy~     subjects.~   "
137626|NCT01765829|"~     The purpose of this study is to assess if patients who continue with antipsychotic treatment~     for 12 or more months show the same risk of relapse (measured by PANSS) that patients with~     the same medical condition who have followed a discontinuation treatment scheme based in the~     presence of prodromes.~      The candidates should accomplish the following criteria: first episode of non-affective~     psychosis who have followed antipsychotic treatment for 12 months and who have already shown~     remission criteria.~   "
137627|NCT01765816|"~     Hypothesis: Exercise will reduce morbidity and mortality rates in an elderly population. The~     extent of reduction will be intensity dependent.~      As part of the Generation 100 study, this sub-study project will investigate the effect of~     exercise on blood volume, cardiopulmonary health and heart function in healthy aging.~     Objective is to determine the acute effect of one endurance training session on blood volume~     in healthy elderly. The working hypothesis is that one interval training session increases~     total blood volume by 10% in healthy elderly, and that there will be no change after moderate~     continuous training.~   "
137628|NCT01765803|"~     This study will investigate the possibility of using the drug thioridazine (also called~     Mellaril) to increase the number of certain types of cells moving from the bone marrow to the~     circulation in a group of healthy humans. The types of cells we hope to collect are called~     CD34+ progenitor, or stem cells. These cells can be used in the laboratory to better~     understand a number of diseases and suggest new strategies for therapy. Perhaps the most~     important potential application of human stem cells is the generation of cells and tissues~     that could be used for cell-based therapies, as a renewable source of replacement cells and~     tissues to treat diseases including Alzheimer's diseases, spinal cord injury, stroke, burns,~     heart disease, diabetes, osteoarthritis, and rheumatoid arthritis.~   "
137629|NCT01765790|"~     The purpose of the study is to assess the safety, tolerability, pharmacokinetics, and~     pharmacodynamics of anti-MIF antibody in subjects with malignant solid tumors (Arm 1) and in~     subjects with metastatic adenocarcinoma of the colon or rectum (Arm 2).~   "
137630|NCT01765777|"~     The purpose of the research study entitled Efficacy of Osteopathic Manipulative Medicine~     (OMM) and Phototherapy for Patients with Chronic Lower Back Pain is to investigate the~     hypothesis that combined treatment with both osteopathic manipulative medicine (OMM) and~     phototherapy will provide greater pain relief for patients with chronic lower back pain, as~     compared with standard medical management or either treatment alone.~   "
137631|NCT01765764|"~     This study will evaluate the safety and efficacy of bimatoprost solution compared with~     vehicle in the treatment of eyebrow hypotrichosis (inadequate eyebrows).~   "
137632|NCT01765751|"~     The purpose of the Manual Cervical Distraction: Measuring Chiropractic Delivery for Neck Pain~     Clinical Trial is to examine the patient‐centered clinical and biomechanical outcomes, doctor~     treatment delivery, and believability characteristics of a commonly used chiropractic~     procedure for the treatment of neck- or neck-related arm pain or disability.~   "
137633|NCT01765738|"~     To determine whether antibiotic impregnated PICC catheters have a lower infection rate than a~     conventional PICC catheter in a tertiary care patient population. Secondary goals will be to~     determine if there is a difference between the two catheters with early and late infections,~     to determine the cost comparison including extra cost of treatment for a line related~     infection, to determine if there are any non-infectious related complication differences~     between the two catheters.~   "
137634|NCT01765725|"~     The aim of the study is to develop, carry out, evaluate and measure the effects of a new~     patient education program for patients with Chronic Fatigue Syndrome (CFS)in primary~     healthcare.~      In an randomized controlled trial design the effects of the patient education program on~     coping, physical functioning, fatigue, pain, acceptance, anxiety, depression, quality of~     life, self- efficacy, and illness perception will be compared with treatment as usual.~      The results of the main project will lead to the elaboration of the final patient education~     program that can be implemented in primary health care, as well as development of a training~     program for future program-conductors.~   "
137635|NCT01765712|"~     The purpose of this research study is to investigate whether or not platelet rich plasma~     (PRP) may help to improve tendon healing and decrease post operative pain in patients~     undergoing anterior cruciate ligament (ACL) reconstructive surgery using their own patellar~     tendons as autografts.~   "
137636|NCT01765699|"~     Aim To identify through data analysis key patients, surgeon and operative dependent variables~     which will improve the performance of knee replacement for primary osteoarthritis~      Research Question~        1. Can the investigators identify association between outcomes and patients characteristics~          using existing (already collected) datasets~        2. What are the characteristics of patients with poor outcome after knee replacement~        3. What can be done to improve the outcome of patients at risk of poor results~   "
137637|NCT01765686|"~     Energy devices are used routinely during thyroid surgery to aid surgical dissection and to~     stop bleeding. The newer generation energy devices have several advantages over older~     machines. The two most commonly used newer generation energy devices are the Harmonic scalpel~     and the Small Jaw bipolar device. Currently there has been no randomized controlled trial~     that compares both devices side to side. We aim to compare the effectiveness of these two~     newer generation energy devices in thyroid surgery.~   "
137638|NCT01765673|"~     This is a device evaluation study to determine the optimal stimulation characteristics for~     using vibrotactile stimulation as a sensory triggering device for self retraining in patients~     with chronic moderate to severe dysphagia. Stimulation characteristics to be tested are~     frequency of vibration, pressure between the device and the skin, mode of vibration (pulsed~     or continuous).~   "
137639|NCT01765660|"~     The purpose of this study is to evaluate the utility of treating patients experiencing~     refractory chronic graft-versus-host disease with ex-vivo-expanded BM-drived mesenchymal stem~     cells from third-party donors. The objective was to evaluate the effect and safety of such~     treatment on refractory chronic graft-versus-host disease.~   "
137682|NCT01765101|"~     Using double blind, randomized controlled design to study the immediate, short-term and~     intermediate-term therapeutic effects of ready-made full-length lateral wedged shoe insoles~     and customized full-length lateral wedged shoe insoles to patients with knee osteoarthritis,~     under the basis of International Classification Functioning, Disability and Health.~   "
137640|NCT01765647|"~     Celiac disease (CD) is an autoimmune disease of the small intestine caused by the consumption~     of gluten proteins from widely used food sources such as wheat, rye, and barley. Exposure of~     the small intestine to gluten causes an inflammatory response, leading to the destruction of~     intestine lining, often with severe symptoms including diarrhea, abdominal distention,~     fatigue, weight loss, anemia, and neurological symptoms. CD is a lifelong disease and the~     only treatment currently available is strict adherence to a life-time gluten free diet (GFD).~     However, adhering to this diet is difficult as gluten proteins are found in many food~     products. Therefore, the gluten-free diet has both lifestyle and financial implications for~     the individual and thus has been potential for impacting adversely on their quality of life.~      Various approaches are being studied to reduce the need for careful control of the diet for~     those with CD, including the use of antibodies such as IgY. IgY is produced from the egg~     yolks of super immunized laying hens. Egg yolk antibodies are natural products with minimal~     toxicity, for those without egg allergy, and offer low-cost, hygienic production of study~     product. Once the IgY antibody is put into capsule form, it is called AGY.~      Individuals with CD will be recruited only if they have a history of biopsy proven CD,~     currently follow a GFD but continue to have mild to moderate symptoms related to gluten~     exposure, and do not have an egg allergy. Blood will be tested for ATG antibody levels at~     screening. Those enrolled will have a 2 week run-in period where diet and symptoms are~     recorded, and will then receive AGY capsules to take with meals over a 4 week period.~     Outcomes will be measured by examining lab test results including antibody levels, symptoms,~     and quality of life.~   "
137641|NCT01765634|"~     The purpose of this study is to evaluate the utility of treating patients experiencing~     refractory acute graft-versus-host disease with ex-vivo-expanded BM-drived mesenchymal stem~     cells from third-party donors. The objective was to evaluate the effect and safety of such~     treatment on refractory acute graft-versus-host disease.~   "
137642|NCT01765621|"~     Leumit Health Services, an health maintenance organization operating in Israel, will~     incorporate a web-based, decision support system for handling drug-drug interactions and drug~     information, termed DDI+ reinforced with patient specific pharmacogenetic data. The~     investigators hypothesize that implementing such a system will reduce health-care~     expenditures (e.g., hospital admissions, referrals to ERs, Imaging procedures).~   "
137643|NCT01765608|"~     This RCT explores the efficacy of Zonisamide (Zonegran®)on overweight/obese in patients with~     moderate to severe obstructive sleep apnea. Patients will be randomized to receive~     zonisamide, placebo or nasal continuous positive airway pressure (nCPAP) during 4 weeks. A 5~     month open extension part will follow when patients in the tablet groups will all receive~     zonisamide. Patients in the open CPAP group will continue with CPAP treatment.~      Study hypothesis:~      Controlled pharmacological weight reduction with Zonisamide will result in elimination of OSA~     and OSA sequels more effectively than nCPAP due to incomplete compliance with the mechanical~     treatment and a lack of direct beneficial metabolic effects after nCPAP. Further it is~     hypothesized that zonisamide has a direct pharmacological effect on respiratory control~     during sleep by its carbonic anhydrase inhibitory effects and this will result in a reduction~     of sleep disordered breathing.~   "
137644|NCT01765595|"~     Leumit Health Services, an health maintenance organization operating in Israel, will~     incorporate a web-based, decision support system for handling drug-drug interactions and drug~     information, termed DDI+. the investigators hypothesize that implementing such a system will~     reduce health-care expenditures (e.g., hospital admissions, referrals to ERs, Imaging~     procedures).~   "
137645|NCT01765582|"~     This randomized, open-label, multicenter study will evaluate the efficacy and safety of~     folinic acid (leucovorin), 5-fluorouracil (5-FU), oxaliplatin, and irinotecan (FOLFOXIRI) /~     bevacizumab regimens (concurrent and sequential) versus folinic acid (leucovorin),~     5-fluorouracil, and oxaliplatin (FOLFOX) / bevacizumab in first-line in participants with~     metastatic colorectal cancer. Participants will be randomized to receive bevacizumab 5~     milligrams per kilogram (mg/kg) intravenously every 2 weeks with either concurrent or~     sequential FOLFOXIRI or with FOLFOX for 4 to 6 months of induction therapy, followed by~     maintenance therapy with bevacizumab plus either leucovorin/5-fluorouracil or capecitabine~     until disease progression occurs. After disease progression, participants will receive~     treatment with a fluoropyrimidine-based chemotherapy plus bevacizumab.~   "
137646|NCT01765569|"~     This open-label, multi-center, three-period, one sequence study will investigate the effect~     of vemurafenib on the pharmacokinetics of digoxin in patients with unresectable~     BRAFV600-mutation positive metastatic melanoma or other malignant tumor type that harbors a~     V600-activating mutation of BRAF without acceptable standard treatment options. Patients will~     receive multiple doses of vemurafenib in Periods B and C and a single dose of digoxin in~     Periods A and C. Eligible patients will have the option to continue treatment with~     vemurafenib as part of an extension study (NCT01739764). The anticipated time on study~     treatment is approximately 36 days.~   "
137647|NCT01765556|"~     This open-label, multi-center, three-period, one sequence study will investigate the effect~     of ketoconazole on the pharmacokinetics of vemurafenib in patients with unresectable~     BRAFV600-mutation positive metastatic melanoma or other malignant tumor type that harbors a~     V600-activating mutation of BRAF without acceptable standard treatment options. Patients will~     receive a single dose of vemurafenib in Periods A and C and multiple doses of ketoconazole in~     Periods B and C. Eligible patients will have the option to continue treatment with~     vemurafenib as part of an extension study (NCT01739764). The anticipated time on study~     treatment is approximately 19 days.~   "
137648|NCT01765543|"~     This open-label, multi-center, three-period, one-sequence study will investigate the effect~     of rifampin on the PK of vemurafenib in participants with unresectable BRAFV600-mutation~     positive metastatic melanoma or other malignant tumor type that harbors a V600-activating~     mutation of BRAF without acceptable standard treatment options. Eligible participants will~     have the option to continue treatment with vemurafenib as part of an extension study GO28399~     (NCT01739764).~   "
137649|NCT01765530|"~     The purpose of this study is to evaluate the in-vivo efficacy of a novel device (endOclear)~     for cleaning the endotracheal tube (ETT) lumen from secretions. The investigators hypothesize~     that a protocol of routine ETT cleaning with endOclear may increase the ETT luminal volume~     measured at extubation compared to the current standard of care. The device may therefore be~     clinically useful by better maintaining the ETT original function.~   "
137650|NCT01765517|"~     Probiotics, which are believed to be health promoting live microorganisms, have been reported~     to influence circulating endotoxin levels. Ingestion of the live cultures may alter gut~     mircobiota in a beneficial manner to reduce inflammation; although their mechanism and~     influence to reduce inflammation in T2DM is not established for this disease state.~     Therefore, the aim of this study is to (1) characterize the beneficial effects of probiotics~     on circulating endotoxin levels and other biomarkers related to systemic low-grade~     inflammation in patients with T2DM; (2) Compare circulating endotoxin levels and inflammatory~     cytokine levels between patients treated with probiotics or placebo to examine the beneficial~     effects of probiotics on reducing the inflammatory status, through assessment of systemic~     markers (adipokines, endotoxin, cytokines); (3) to examine the effects of probiotics on gut~     microflora in order to understand the mechanism for such change in inflammatory status. To~     achieve this, 120 consenting adult Saudis, naïve or newly diagnosed T2DM patients without~     co-morbidities, will be enrolled in this clinical trial and randomized to receive twice-daily~     placebo or probiotics for 26 weeks in a double-blind manner. Glycemic inflammatory markers~     will be measured and fecal samples analysed, interventions will be done at baseline, 4, 8, 12~     and 26 weeks. It is envisaged that probiotics will induce beneficial changes in gut~     mircobiota, reduce the systemic inflammatory state through altering systemic endotoxin levels~     and, as such, reduce the systemic inflammatory response observed in T2DM subjects. This will~     have a fundamental impact on how we should treat the inflammatory component of T2DM,~     particularly once the results are verified in a larger cohort of patients, as this could have~     very dramatic effects on how we treat patients with T2DM. Reducing the pathogenesis of T2DM~     by dampening the inflammatory response, which may also impact on insulin resistance status~     and health of the individual, will have clear benefits. This could have profound effects on~     preventative T2DM management, as well as current T2DM care without excessive cost for the~     wider Saudi health economy.~   "
137651|NCT01765504|"~     Using the 9 centers (Appendix B) involved with the planned multicenter NIRS comparative~     effectiveness trial the specific aims of this study are:~        1. To demonstrate the feasibility of collecting rScO2 data from patients undergoing cardiac~          surgery in a multicenter study design.~        2. To demonstrate the feasibility of using a standard algorithm for treating rScO2~          desaturations during cardiac surgery in a multicenter study design.~   "
137652|NCT01765491|"~     Morning-only colonoscopy preparation may improve efficiency by allowing same-day patient~     preparation and colonoscopy. The aim of the investigators study is to compare the efficacy~     and tolerability of morning-only Polyethylene Glycol (PEG) to split-dose preparation in~     hospitalized patients undergoing colonoscopy.~      This is a single-center, prospective, endoscopist-blinded study in which hospitalized~     patients scheduled to undergo diagnostic colonoscopy were randomly assigned to receive one~     gallon of PEG either the morning of colonoscopy or as a split-dose (evening-morning). The~     primary end point is efficacy of colonoscopy preparation measured by the Ottawa scale. The~     investigators pre-specified a non-inferiority margin of 1.5 for the difference in Ottawa~     scale between arms. Secondary end points are patient compliance and tolerance.~   "
137653|NCT01765478|"~     HM71224 is a potent small molecule inhibitor of Bruton's tyrosine kinase (BTK). BTK is a~     member of the Tec family of non-receptor protein tyrosine kinases. BTK is mostly expressed in~     hematopoietic cells such as B cells, mast cells and macrophages. BTK plays key roles in~     multiple cell signaling pathways including B-Cell Receptor (BCR) and Fc receptor (FcR)~     signaling cascades and is an essential mediator not only in B-cell dependent but also in~     myeloid cell dependent inflammatory arthritis. HM71224 has been selected as a novel~     therapeutic agent for the treatment of autoimmune diseases such as rheumatoid arthritis (RA).~      In view of the above, further development of HM71224 for the treatment of RA is warranted. In~     this first-in-man (FIM) study, a single and multiple dose escalation design will be employed,~     in which the primary objective is to evaluate the safety and tolerability of the compound.~     The biomarkers included as pharmacodynamic (PD) variables are chosen as they are indicators~     for any effects of HM71224 on the expected mode of action (pBTK, pPLCγ, and pERK).~   "
137654|NCT01765465|"~     Postcholecystectomy syndrome (PCS) includes a heterogeneous group of diseases, usually~     manifested by the presence of abdominal symptoms following gallbladder removal. The~     pathogenesis of PCS has not been identified; therefore there is no consensus of medical~     treatment on PCS. The Action of Rowachol are to inhibit hepatic 3-hydroxy-3-methylglutaric~     acid(HMG)-coenzyme A(CoA) reductase, to inhibits cholesterol nucleation in bile from patients~     with cholesterol gallstones, and to promote biliary lipid secretion.~      The purpose of this study is to determine whether Rowachol is useful in the prevention of PCS~     and symptoms change after laparoscopic cholecystectomy~   "
137655|NCT01765452|"~     The Aim of this study is to prove non-inferiority of Closone to the Combination treatment of~     Plavix with Astrix.~   "
137656|NCT01765439|"~     The aim of the study is to determine, whether administration of VSL#3 (Original De Simone~     formulation) probiotic preparation can alter the bile acid metabolism in patients with~     inflammatory bowel disease.~   "
137657|NCT01765426|"~     The purpose of this study is to compare the safety, tolerability and immunogenicity of~     Takeda's Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] when administered~     intradermally in varied dosing schedules and via different methods of administration~     (conventional needle/syringe versus needle-free PharmaJet® injector).~   "
137658|NCT01765413|"~     It is thought that vaccines trigger innate inflammatory responses to induce antigenspecific~     adaptive immunity (the desired effect), but excessive inflammation may lead to serious~     inflammatory complications or unwanted side effects. Currently there is a lack of reliable~     biomarkers (a measurable biological response that predicts something) able to predict severe~     inflammation and this has resulted in the development of several vaccines being terminated~     and the withdrawal of some licensed vaccines which were associated with inflammatory~     complications.~      This study is part of the BIOVACSAFE project which is a 5year €30M project funded by the~     Innovative Medicine Initiative. The project involves a series of clinical studies using~     licensed vaccines as benchmarks to generate clinical data on inflammation and identify~     biomarkers that can be used to predict acceptable reactogenicity. The target is to identify~     biomarkers that can predict the occurrence of beneficial and detrimental effects in response~     to a vaccine. Such biomarkers could be used in future vaccine development programs to~     optimize selection of vaccine candidates with a profile that will be unlikely to generate~     worrisome safety signals once they are in generalized use.~      This study is one in a series of training studies which will each use different licensed~     vaccines that are prototypical representatives of a class of vaccine used in a particular~     target population. Forty eight subjects will be randomised into three groups to receive: A)~     Varicella zoster vaccine (n = 20), B) Yellow Fever vaccine (n = 20), C) Saline placebo (n =~     8). Following a screening visit, participants will undergo a seven day residential visit~     which will include immunization and intensive monitoring of physiological (e.g. heart rate,~     oral temperature, blood pressure) metabolic and immune (innate and adaptive) parameters. This~     visit will be followed up by four outpatient visits with further monitoring and blood~     samples.~   "
137659|NCT01765400|"~     The investigators aim to determine if patients with systolic heart failure treated with~     prasugrel achieve greater platelet inhibition compared to those treated with clopidogrel.~   "
137660|NCT01765387|"~     The aim of this study is to evaluate the recovery effect of Spa therapy after aerobic~     exercise in cardiovascular, performance and perceived fatigue. A pragmatic controlled~     repeated measures, single-blind, trial is conducted. Thirty-four recreational sportspeople~     are required to visit a Sport-Centre and are assigned to a Spa-therapy or rest in a bed~     (control group) after complete a spinning session.~   "
137662|NCT01765361|"~     Multiple Sclerosis (MS) is not only an 'inflammatory' demyelinating disease, but also~     includes axonal and neuronal injury in the grey matter . Neurodegenerative processes are~     partly independent of lesion formation and relapse activity , but represent the direct driver~     of clinical long-term disability and cognitive decline.~      Multimodal evoked potentials (EP), i.e. the combination of visual, somato-sensory and motor~     EP (VEP, SSEP, MEP) have been shown prospectively to provide objective, monovectorial, and~     numerical data which are closely correlated to the EDSS. As EP capture the functional~     integrity of the examined systems they represent a method unbiased for directional changes,~     while remaining specific for the neuronal function, and hence can measure deterioration, as~     well as improvement, a germane advantage to capture drug response.~      High-resolution electroencephalography (EEG) allow for explorative analysis of potential~     surrogate markers for cognitive decline.~      Ocrelizumab (OCR), a humanized anti-CD20 monoclonal antibody has shown strong treatment~     effects on number of T1Gd-enhancing lesions , on new T1Gd-enhancing and new T2-hyperintense~     lesions as well as on the annualized relapse rate in a recent phase II trial in~     relapsing-remitting MS.~      The present study will investigate the effects of OCR on multimodal evoked potentials (EP),~     Furthermore, quantitative EEG as a potential correlate of cognitive dysfunction and fatigue~     will be explored.~   "
137663|NCT01765348|"~     Specific-language-impairment (SLI) is defined as a significant disorder in language~     development, which affects one's daily functioning, but not attributable to sensory,~     intellectual or neuropsychological deficit. Children with SLI make up one of the largest~     subgroups of students with special educational needs (SEN) in Hong Kong. Without appropriate~     intervention, SLI may persist into adolescence and lead to long-term literacy difficulties~     and social rejection, which were found to be associated with societal problems like~     unemployment and crime commitment. Among the language domains, syntax/grammar has been viewed~     as a core deficit in these children. Speech-Language-Pathologists (SLPs) often provide~     intervention on this aspect for them. However, very few intervention efficacy studies could~     be identified.~      Without pertinent research evidence, clinical-decision-making in treatment approach selection~     may be dubious. This study aims to evaluate the efficacy of two procedures for syntax~     intervention, namely the Sentence-Combining (SC) and Narrative-Based (NAR) procedures using a~     randomized-controlled-trial (RCT) design. These two procedures have been indicated to be~     effective in previous case reports and expert opinions. By using the rigorous study design of~     RCT, this study provides stronger evidence to support clinicians in determining the most~     effective treatment procedure. To achieve sufficient statistical power to detect the~     treatment difference, 52 children with SLI will be recruited and randomly assigned to one of~     the treatment groups. The primary outcome will be measured by a standardized language~     assessment. Intention-to-treat analysis will be employed. Pre- and post-treatment scores on~     the outcomes will be subject to analyses of covariance with the pre-treatment scores as the~     covariate.~   "
137664|NCT01765335|"~     HF represents a major burden in the developed world. Mortality and rehospitalization rates~     post-discharge in patients admitted with HF may be as high as 15%-30% within 60-90 days,~     respectively. Given that rehospitalization drives much of the cost associated with HF, there~     has been increased interest in predicting risk of rehospitalization as a means to control~     health care costs. These risk stratification models can serve as important clinical tools by~     helping to identify those patients who are at very high risk may be observed more closely or~     treated more intensively. The most important predictors for the combined endpoint of death or~     rehospitalization were admission serum creatinine concentration, systolic blood~     pressure,admission hemoglobin level, discharge use of ACE-Ior ARBS, and Pulmonary disease.~     Other independent predictors during hospitalization of readmission and mortality included low~     admission Kansas City Cardiomyopathy Questionnaire score, high BNP, hyponatremia,~     tachycardia, hypotension, absence of b-blocker therapy, and history of diabetes and~     arrhythmias. Nevertheless, both models fail to provide the treating physician a simple~     decision making tool for predicting which patient is stable enough to be discharged from the~     hospital without a high risk of readmission. The Non Invasive Cardiac System (NICaS, Israel),~     calculates the cardiac output by measuring impedance cardiography in a tetra-polar mode,~     derived from electrodes placed on both wrists or one wrist and the contra-lateral ankle. This~     simple to operate, non-invasive technique was validated in a few studies to be reliable in~     estimation of CO compared to traditional, invasive techniques in different settings including~     HF patients. A previous study demonstrated that parameters derived from this system showed a~     highly significant correlation to echo estimated EF and serum BNP in chronic HF patients and~     were equally able to predict complications in this population. Aim:To assess whether the~     NICaS system can identify high risk HF patient for readmission prior to their discharge~     compared to serum BNP measurement.~   "
137665|NCT01765322|"~     The purpose of this study is to determine whether laser-assisted zona thinning improve the~     implantation rate of the women of advanced age in the first IVF/ICSI cycles~   "
137666|NCT01765309|"~     Investigation of whether injection of the pectoralis muscle with 100 units botulinum toxin~     during breast reconstruction with tissue expanders results in decreased pain using a blinded,~     randomized, controlled trial.~   "
137667|NCT01765296|"~     -  6-week Efficacy Study The objective of this study is to prove the safety and~          non-inferiority of analgesic efficacy of CG100649 2 mg vs. celecoxib 200 mg, and~          analgesic superiority of CG100649 2 mg vs. placebo, when administered once a day in~          patients with osteoarthritis of the hip or knee over the 6 week Treatment period. The~          primary efficacy parameter is the difference from Baseline to Week 6 in the Western~          Ontario and McMaster Universities Index of Osteoarthritis (WOMAC)-Pain subscale.~        -  Extended Safety Study The objective of the Extended Safety Study is to collect a total~          of 24 weeks of safety data for CG100649 including the initial 6 weeks of safety data,~          and an additional 18 weeks of safety data for those subjects who agree on the consent~          form to continue into the Extended Safety Study. Subjects will be administered CG100649~          2 mg only during 18 weeks of Extended Safety Study.~   "
137668|NCT01765283|"~     The purpose of this study is to assess the safety and to appraise the efficacy of one cycle~     of Hepastem (Heterologous Human Adult Liver-derived Progenitor Cells, HHALPC) infusions in~     paediatric patients suffering from CN or UCD.~      The study duration: 12 months starting from the day of treatment: 6 months active~     surveillance and 6 months observation post-infusion.~   "
137683|NCT01765088|"~     This study is being conducted to help determine whether the addition of~     Interferon-alpha(α-IFN),which were determined sensitized the activity of Temozolomide(TMZ) in~     vivo and vitro, when given along with temozolomide during the monthly cycles that follow~     radiation, is able to delay tumor growth, shrink tumors, or impact how long people with newly~     diagnosed high-grade glioma.~   "
137684|NCT01765075|"~     The purpose of the study is to gather electrophysiological data using a multi-electrode~     mapping catheter during a clinically indicated cardiac ablation procedure for the treatment~     of persistent atrial fibrillation.~   "
137669|NCT01765270|"~     Individuals with type 2 diabetes mellitus (T2DM) are at increased risk for cardiovascular~     events (for example, heart attack) and the risk is related to one's overall control of blood~     glucose levels. In this study the investigators will measure the effects of saxagliptin,~     compared to placebo, before, during, and after coronary artery bypass graft (CABG) surgery.~     The investigators will use samples of the patients' blood and tissue to measure and evaluate~     indicators of the body's response to the treatment. This study is being done to evaluate the~     effect of saxagliptin on biomarkers of the heart to help us understand whether reducing or~     controlling a person's blood glucose levels during and after CABG surgery will produce better~     clinical outcomes (for example, better heart health).~   "
137670|NCT01765257|"~     Among the psychiatric symptoms observed in the premotor phase of Parkinson's disease (PD)~     and/or in de novo patients, apathy is relatively frequent (estimated to 23%). However, the~     neuropathological bases of apathy are still unknown. However, recent data suggests that~     apathy could be linked to a more specific dopaminergic denervation in the ventral striatum.~      Rasagiline increases the bioavailability of striatal endogenous dopamine by blocking the~     MAO-B. Some recent data suggest rasagiline could be effective to improve apathy in~     Parkinson's disease.~      The primary outcome is to demonstrate a significant reduction of apathy using the Lille~     apathy rating scale (LARS) in drug naive patients with early diagnosed Parkinson's disease,~     using a treatment by rasagiline.~   "
137671|NCT01765244|"~     This is a prospective, phase I-II, randomised, open-label clinical trial that will evaluate~     the safety and feasibility, as well as clinical efficacy evidence, of a bioengineered~     anterior corneal substitute in adults with severe trophic corneal ulcers. This model of human~     anterior allogeneic cornea will provide an alternative approach in cases where human donor~     keratoplasty is not an option.~   "
137672|NCT01765231|"~     The purpose of this study is to identify the effect of prophylactic entecavir in HBsAg~     Negative/HBcAb Positive/hepatitis B virus DNA Negative patients with lymphoma.~   "
137673|NCT01765218|"~     We wish to see whether topiramate (an anti-epileptic agent) improves the outcome of babies~     with neonatal hypoxic encephalopathy who are receiving whole body cooling.~   "
137674|NCT01765205|"~     Previous studies have examined the usefulness of pulse oximetry or oxygen saturation to~     screen for left-sided cardiac lesions. These studies have shown that the occurrence of~     critical congenital cardiac malformations among asymptomatic newborns is high; the technique~     of pulse oximetry is reliable for detection of ductal dependant left-sided lesions, simple to~     operate(requires little time and can be done in the newborn nursery) and is cost effective;~     there is effective follow-up test (heart ultrasound) and available interventions have an~     effect on outcome for diagnosed newborns. The importance of this research project is to~     examine the overall helpfulness of measuring oximetry in newborn infants using somatic~     oximetry, as well ast to prepare for a population based study in the state of Florida.~   "
137675|NCT01765192|"~     This study will evaluate the effect of roflumilast 500 μg once daily (QD) plus montelukast 10~     mg QD versus 10 mg montelukast QD alone on predose (trough) prebronchodilator forced~     expiratory volume in the first second (FEV1).~   "
137676|NCT01765179|"~     The purpose of the study is to determine if oral testosterone undecanoate is effective and~     safe in the treatment of low testosterone in men.~   "
137677|NCT01765166|"~     This Competing Renewal project continues the research and development of a parent-focused~     intervention, Parent Guide to SSGRIN, which parallels an established child-focused~     intervention [Social Skills GRoup INtervention (S.S. GRIN); for children ages 8-12 years], in~     order to teach and reinforce the same social skills and concepts within the home environment.~     A primary goal is to address questions of relative impact, longer-term treatment benefits,~     and differential treatment effects of the Parent Guide training on children's social skill~     development across settings and populations.~   "
137678|NCT01765153|"~     The objective of the study was to determine the efficacy of two forms of physical therapy~     training, one emphasizing precise, visually guided walking over obstacles and on targets~     (Precision Training), the other emphasizing mass practice of walking on a treadmill~     (Endurance Training). The hypothesis was that visually guided training (Precision) may be~     especially efficacious because it engages the motor cortex, whose input may facilitate~     improvements in functional walking. Participants are individuals with a chronic (≥7 months~     post-injury), motor incomplete spinal cord injury (SCI), with no other problems that would~     preclude participation in an intensive training program. A randomized, single-blinded,~     cross-over design was used to randomly allocate participants to start with Precision or~     Endurance Training, identified as Training Phase I. Training was 5x/wk for 2 months, followed~     by a 2-month rest period, identified as Rest Period I. Participants then returned for~     2-months of training in the other method, identified as Training Phase II, followed by~     another 2-month rest, Rest Period II. Measures of walking speed, distance, skill, confidence,~     as well as depression were obtained at least 3 times before any training, then monthly~     thereafter. Electrophysiological measures were taken before and after each phase of training~     and period of rest. Change scores were used to determine how each phase of training and rest~     influenced the scores (see below).~   "
137679|NCT01765140|"~     This is a continuing project to provide 3,4 diaminopyridine (DAP) under a treatment-use IND~     to patients with Lambert-Eaton myasthenia (LEM) and congenital myasthenic syndrome (CMS).~   "
137680|NCT01765127|"~     This post-marketing Modified Prescription-Event Monitoring (M-PEM) safety study of asenapine~     (SYCREST®) is to be carried out by the Drug Safety Research Unit (DSRU) as part of the Risk~     Management Plan required by the Committee for Medicinal Products for Human Use (CHMP) to~     further investigate the safety profile of asenapine in clinical practice. The aim of this~     study is to proactively capture safety and drug utilisation data in the post-marketing phase~     of license approval of asenapine as prescribed to patients by general practitioners (GPs) in~     England. This data is obtained through the completion of questionnaires by GPs.~   "
137681|NCT01765114|"~     The aim of this study is therefore to investigate the efficacy of the PEG-formulation to~     reduce the frequency and duration of genital herpes recurrences, to assess its safety and~     tolerability and to investigate its effect on shedding.~   "
137685|NCT01765062|"~     Many author have exposed the rapid and slow expansion, the diversity of activation and~     containment protocols and the follow-up time, justify the need for more studies to evaluate~     the effects to the ERM for the long-term.~   "
137687|NCT01765036|"~     Ductal adenocarcinoma is the most frequent pancreatic solid lesion and the most common tumor~     of the pancreas. Given its poor prognosis and the major therapeutic consequences, the~     discrimination between PA and other pancreatic solid lesions is mandatory. EUS is admitted as~     the most sensitive imaging procedure for the detection and characterization of pancreatic~     tumors [1-3]. Nevertheless it remains difficult to differentiate, on morphological features,~     PA from other solid masses. For 15 years, endoscopic ultrasound fine needle aspiration~     (EUS-FNA) has demonstrated its efficiency for tissue sampling and cyto-histologic diagnosis~     of PA. However, the negative predictive value (NPV) for the diagnosis of pancreatic~     adenocarcinoma (PA) remains low (30-70%) in the published prospective series [4]. So, in case~     of negative result, the choice between surgery and follow-up remains difficult. Additional~     criteria to get the decision are then warranted.~      The assessment of pancreatic tumor enhancement using ultrasound contrast agents (UCAs) in~     real time with imaging specific methods seems useful to improve their characterization [4-8]~     either by contrast-enhanced EUS (CE-EUS) or, more recently, by contrast-enhanced harmonic EUS~     (CH-EUS).~      The aims of this prospective multicenter study is:~        1. to compare the NPV of contrast-enhanced endoscopic ultrasound (CH-EUS) and EUS-FNA for~          the diagnosis of PA;~        2. to assess the intra- and inter-observer concordances of CH-EUS for the diagnosis of PA.~   "
137688|NCT01765023|"~     The purpose of the study is to assess the pharmacokinetic interactions between atorvastatin~     and metformin single or co-administered in healthy volunteers~   "
137689|NCT01765010|"~     The purpose of this study is to compare the effect of inactive and active vitamin D on serum~     sclerostin and dickkopf1 levels.~   "
137690|NCT01764997|"~     Primary Objective:~      To demonstrate the treatment effect of sarilumab and methotrexate (MTX) compared to~     etanercept and MTX in participants with rheumatoid arthritis (RA) and an inadequate response~     to adalimumab and MTX by evaluation of the Disease Activity Score for 28 joints (DAS28).~      Secondary Objectives:~      To assess the signs and symptoms of RA in participants taking sarilumab in combination with~     MTX.~      To assess the quality of life of participants with RA taking sarilumab in combination with~     MTX.~      To assess the safety and tolerability of sarilumab in combination with MTX in participants~     with RA.~   "
137691|NCT01764984|"~     Osteoarthritis is a progressive disease afflicting to two thirds of Americans. Today, an~     estimated 43 million individuals have arthritis. By 2020, more than 59.4 million Americans~     will be affected by the disease. Despite the relative good track record of total knee~     replacement, it remains a biomedical device that can fail over time. A recent study looking~     at the current mechanisms of total knee replacement failures, listed polyethylene wear and~     osteolysis around implants. The material used for polyethylene insert as well as the~     conformity of articular surface of implants has been modified to decrease wear. While~     introducing modularity, the usage of metal backing in tibial base plates became obvious as it~     offered better stress distribution to the proximal tibial bone. However, it introduced other~     modes of failures. Micromotion has been demonstrated between the metal backing and the tibial~     liner, and produced backside polyethylene wear in 44% of implants at retrieval for revision.~     Factor influencing the surgeon's choice of implant include: reproductibility and longevity of~     results, technical difficulty of implantation, cost, and impact on bone stock. The modulus of~     elasticity of the tibial base plate has a direct effect on periprosthetic bone biology.~     Studies have described a significant decrease in postoperative Bone mineral density (BMD),~     adjacent to the implants, after total knee replacement. No study, to our knowledge, has~     looked at BMD in vivo after total knee replacement comparing different tibial base plate~     designs. Direct effect of changes in design on overall implant survival can be studied with~     randomized clinical trials isolating specific variables. No randomized clinical trial has~     looked at tibial insert stiffness and modularity, and it effect on bone density changes,~     synovitis, osteolysis or survivorship. In order to isolate stiffness and modularity as study~     variables, one would aim at randomizing an homogenous patient population undergoing total~     knee arthroplasty with implants of similar articular geometry designs with different tibial~     insert modularity and stiffness.~   "
137692|NCT01764971|"~     Intracranial hemorrhage despite being rare, several chronic ITP patients experience moderate~     to severe behavioral problems including learning difficulties, memory affection .These~     changes could be due to the presence of minute capillary dysfunction~   "
137693|NCT01764958|"~     The proposed research has the potential of contributing to the limited empirical literature~     on the relationship between maternal sensitivity and motor development of preterm infants. If~     indeed maternal attuned behaviors will be found to be associated with the quality of motor~     development, such a finding will support the effectiveness of physical therapy in guiding~     caregivers to attune their holding and touch of preterm infants.~      We hypothesize that mothers and infants' attunement during observed interaction will be~     related to the quality of preterm infants' spontaneous movements in the following ways:~     First, better maternal attunement to the infants needs, and in particular attunement of~     holding and touch will be associated with better quality of spontaneous movements of the~     infants. Second, more initiations and/or involvement of infants in interaction will be~     associated with better maternal attunement to the infant. Third, more initiations and/or~     involvement of infants in interaction will be associated with better quality of spontaneous~     movements and better achievements in developmental milestone. All hypotheses will be examined~     while controlling for maternal use of SSC method during hospitalization after birth and~     family demographic backgrounds.~   "
137694|NCT01764945|"~     The objective of the current study is to investigate the relative bioavailability of two~     different doses of BI 201335, administered as soft gelatine capsule in comparison to the~     equivalent doses of three different oral solution per dose of BI 201335.~   "
137695|NCT01764932|"~     In patients scheduled for thoracic surgery or upper abdominal surgery, investigators will~     determine the accuracy of the epidural catheter placement by using fluoroscopic imaging.~      Previous studies have drawn contradictory conclusions based the potential flaw assumption of~     100% success rate for correct epidural catheter placement in the thoracic region.~   "
137696|NCT01764919|"~     This protocol will evaluate the sensitivity and specificity of [124I]FIAU as a diagnostic~     imaging agent for the detection of osteomyelitis in patients with diabetic foot infection.~   "
137697|NCT01764906|"~     The purpose of this study is to evaluate the efficacy and safety of Novosis in posterolateral~     fusion~   "
137698|NCT01764893|"~     The null hypothesis for this study is that the combination of solifenacin and Percutaneous~     Tibial Nerve Stimulation (PTNS) is not different from PTNS alone. However the investigators~     anticipate a 20% improvement in patients receiving combination therapy as measured by the~     OAB-q (Overactive Bladder questionnaire) scores.~   "
138038|NCT01760473|"~     The study is designed to compare the abuse liabilities of intranasal buprenorphine and~     buprenorphine/naloxone in individuals who are physically dependent on sublingual~     buprenorphine. The investigators hypothesize that the abuse liability of~     buprenorphine/naloxone is lower than that of buprenorphine alone.~   "
137699|NCT01764880|"~     Heparanase cleaves heparan sulfate (HS) chains, a natural substrate for heparanase, and~     participates in degradation and remodelling of the extra-cellular matrix (ECM) facilitating,~     among other activities, cell invasion associated with cancer metastasis, angiogenesis, and~     inflammation. The heparanase enzyme is a promising target for development of new anticancer~     drugs. HS and the structurally related heparin are present in most animal species. As an~     analogue of the natural substrate of heparanase HS, heparin is considered to be a potent~     inhibitor of heparanase. SST0001 is a polymer with a heparin-like structure. It is a reduced~     oxidized N-acetyl heparin, these modifications cause the reduction of anticoagulant activity~     and are strictly related to the anti-heparanase activity. In preclinical murine models~     SST0001 showed a significant anti myeloma effect in multiple myeloma mice xenograft models,~     with a significant reduction of subcutaneous growth of different multiple myeloma cell lines,~     when SST0001 was administered either alone or in combination with dexamethasone. The purpose~     of this study is to determine the safety and tolerability of escalating doses of SST0001 in~     the treatment of advanced refractory multiple myeloma.~   "
137700|NCT01764867|"~     The purpose of this study is to compare treatment outcomes between measurement based~     Algorithm Guided Treatment and Treatment As Usual strategies in a Chinese population with~     major depressive disorder.~   "
137701|NCT01764854|"~     The purpose of this study is to determine if the study drug is safe, tolerable and active in~     reducing fluid overload/weight gain between dialysis sessions for patients with End Stage~     Renal Disease on Hemodialysis.~   "
137702|NCT01764841|"~     The purpose of this study is to evaluate if the time to first pulmonary exacerbation of~     bronchiectasis or its frequency can be prolonged by inhalation of ciprofloxacin for 28 days~     every other 28 days or for 14 days every other 14 days over 48 weeks.~   "
137703|NCT01764828|"~     This is an open-label, uncontrolled, Phase Ib study designed to evaluate the safety,~     tolerability, and pharmacokinetics of BAY86-9766 when given as a single agent and in~     combination with gemcitabine in Asian patients with advanced or refractory solid tumors.Blood~     samples for PK (pharmacokinetics) analyses will be collected after a single dose of~     BAY86-9766, multiple doses of BAY86-9766, and combination treatment of gemcitabine and~     BAY86-9766.~      Safety evaluation will include adverse events assessment, vital signs, laboratory tests,~     12-lead ECG ECG (electrocardiography), cardiac function test, and ophthalmologic examination~     at various time points during the study.~   "
137704|NCT01764815|"~     The purpose of this study is to provide proof-of-concept that directional stimulation, in an~     intraoperative setting, is perceivable in a subject and is different from omnidirectional~     stimulation. The tests will be performed using a dedicated DBS lead connected to external~     neurostimulator.~   "
137705|NCT01764802|"~     This randomized phase II trial studies how well psychosexual intervention works in patients~     with stage I-III gynecologic or breast cancer. Psychosexual intervention may improve sexual~     and psychosocial function.~   "
137706|NCT01764789|"~     This pilot clinical trial studies stress reduction in improving quality of life in patients~     with recurrent gynecologic or breast cancer. Participating in a stress reduction program may~     help improve quality of life in patients with gynecologic or breast cancer.~   "
137707|NCT01764776|"~     This study is to evaluate the pharmacokinetics and safety of 800 mg of LDE225 in subjects~     with impaired hepatic function and healthy subjects with normal hepatic function.~   "
137708|NCT01764763|"~     Recently epiaortic ultrasound scanning (EAS) has been recommended as an intraoperative tool~     to accurately assess ascending aorta disease. To date, several studies have reported that EAS~     is superior to TEE and surgical palpation~   "
137709|NCT01764750|"~     Surgical wound infections remain a serious problem despite aseptic techniques and the use of~     prophylactic systemic antibiotics. Such infections can occur at rates up to ~20% in high-risk~     patients receiving long segment instrumented spinal fusions for deformity correction and~     present potentially catastrophic consequences. Given this, the high cost of treatment, and a~     payer system unable to support such expenses, investigators must make every effort to find~     new cost-effective ways to prevent these complications.~      Increasingly surgeons have sought to address this problem by placing lyophilized Vancomycin~     into spinal surgery wounds immediately prior to wound closure. This method, known as~     intrasite application, is adapted from techniques used to prevent infection in joint~     replacement surgeries. The motivation for this practice is to maximize antibiotic~     concentration within the wound while minimizing systemic concentration and toxicity, (the~     inverse of the situation when using IV antibiotics). While the popularity of intrasite~     delivery has grown rapidly, this has occurred without prospective scientific evidence.~     Recently, three retrospective papers including nearly 2,500 treated patients, indicated that~     intrasite Vancomycin reduces wound infections without increasing adverse events[1-3].~     However, there are no published data on the dosing or pharmacokinetics of intrasite~     Vancomycin, let alone prospective trials of its efficacy and safety.~      The investigators propose to perform the first prospective trial of intrasite Vancomycin~     pharmacokinetics and safety. Study objectives will include standardizing application and~     dosing, defining peak/trough concentrations and clearance parameters, verifying bactericidal~     potency, and dose selection for use in future studies. This will be accomplished by enrolling~     groups of patients (n=10) to receive one of three doses of intrasite lyophilized Vancomycin~     (3, 6 or 12 mg/cm2), prior to wound closure. Vancomycin concentrations in venous blood and~     wound seroma fluid will be measured at regular intervals after surgery to establish~     pharmacokinetic parameters. Preliminary data regarding local and systemic adverse events~     including wound healing, fusion rate, and toxicity will be prospectively collected. The~     ultimate goal of this learning-phase study is to gather sufficient information regarding~     application, dosing, pharmacokinetics, measurement strategies, and adverse events to prepare~     for a Phase III efficacy trial.~   "
137710|NCT01764737|"~     The purpose of this study is to evaluate the safety and tolerability of IV administration of~     VX15/2503 in patients with multiple sclerosis. The escalation part of the study will~     determine the maximum tolerated dose (MTD) or the Maximum Administered Dose if no MTD is~     found.~   "
137711|NCT01764724|"~     Sodium-related claims on food labels should help people find lower sodium food choices;~     however consumer attitudes and understanding of such claims are unknown.~      The objective of this study was to evaluate: 1) the attitudes and understanding to different~     types of permitted sodium claims and 2) the effect of hypertension on responses to such~     claims.~   "
137712|NCT01764711|"~     This study is to determine different chemical levels in the blood during a low salt diet.~     This study will compare normal volunteers to those with Postural Tachycardia Syndrome (POTS)~   "
137735|NCT01764412|"~     Hepcidin is the major hormone regulating Iron Metabolism. In a normal organism decrease iron~     stock causes a decrease in hepcidin synthesis thus promoting intestinal absorption of iron.~      The interpretation of hepcidin dosage results requires to know the physiological variations~     of this hormone.~      This study investigate whether there are significant variations in the values of serum~     hepcidin rates during the menstrual cycle in order to make recommendations on the practical~     dosage determination of hepcidin in premenopausal women.~   "
137713|NCT01764698|"~     Anxiety disorders are highly prevalent among those with substance use disorders, but the~     majority of addictions treatment centers provide little to no evidence-based treatment for~     anxiety disorders. Furthermore, tension reduction models suggest that treating anxiety should~     also improve substance use outcomes. This study is aimed at improving symptoms for people who~     have substance use and anxiety problems. The study is comparing regular Intensive Outpatient~     treatment for addiction to Intensive Outpatient treatment for addiction plus treatment for~     anxiety disorders. Clinicians at a community addictions clinic will participate by receiving~     training in delivering cognitive behavioral therapy for anxiety disorders and will deliver~     the treatment to the patient participants. They will also complete some questionnaires.~     Patient participants will be asked to complete a baseline assessment. Those who are eligible~     will be randomly assigned to one of the two treatment groups. Those who are assigned to~     addiction treatment as usual will continue their regular care at the Matrix Institute.~     Participants who are assigned to also receive the anxiety treatment will be asked to~     participate in 6, 90-min treatment sessions and an orientation session. All participants will~     be asked to complete post-treatment and follow-up assessments. The assessments should take~     approximately 1 hour, and the follow-up assessment will be completed 6 months after treatment~     is over. It is hypothesized that those who get the additional anxiety disorder treatment will~     show greater improvement in anxiety and substance use outcomes than those who get Intensive~     Outpatient Program without the anxiety disorder treatment.~   "
137714|NCT01764685|"~     Heavy drinking (HD) is a risk factor for HIV transmission and is more common in HIV+~     individuals than in the general population. HD adversely affects health directly and reduces~     adherence to antiretroviral therapies (ARTs), in part due to alcohol-induced cognitive~     impairment. Reduced drinking improves cognitive performance and adherence to ARTs.~     Medications approved in the United States to treat alcohol dependence have a small effect~     size. However, topiramate, FDA-approved as an anticonvulsant and a prophylaxis for migraine,~     has a greater effect size in reducing drinking and promoting abstinence in alcohol dependent~     individuals. To date, there are no studies of the effects of topiramate in HIV+ heavy~     drinkers. The investigators propose to conduct a randomized, parallel-groups,~     placebo-controlled, 11-week trial of topiramate in 40 HIV+ heavy drinkers who want to reduce~     or stop their drinking. There are three primary hypotheses for this feasibility and~     proof-of-concept study. First, the investigators hypothesize that topiramate-treated patients~     will decrease the frequency of their HD more than placebo-treated patients. Second, based on~     scores from computerized neurocognitive assessments, the investigators hypothesize that~     topiramate and placebo groups will show similar performance on a battery of cognitive tests.~     Third, based on self-reported medication adherence, the investigators hypothesize that~     adherence to ARTs will be greater in the topiramate group than in the placebo group. These~     findings will provide preliminary data to support a more definitive trial of topiramate for~     the treatment of HD in HIV+ heavy drinkers.~   "
137715|NCT01764672|"~     The goal of the study is to use graph theory to examine how the organization of the~     functional brain network may be altered by the administration of methylphenidate. This effect~     is to be compared between methylphenidate intake and placebo intake, as well as between~     healthy adult males and adult males with a diagnosis of Attention Deficit Hyperactivity~     Disorder.~   "
137716|NCT01764659|"~     The primary objective is to study the feasibility and efficacy of individually optimized CE~     4D-CT for PDA in radiotherapy simulation.~   "
137717|NCT01764646|"~     RATIONALE: It is not yet known whether extreme hypofractionation is equally safe and~     effective than standard radiation therapy in treating prostate cancer.~      PURPOSE: This protocol presents a randomised phase II study aiming to investigate the~     tolerance and disease control of extreme hypofractionated Radiation Therapy for prostate~     cancer.~   "
137718|NCT01764633|"~     The primary objective was to evaluate the effect of treatment with evolocumab, compared with~     placebo, on the risk for cardiovascular death, myocardial infarction, stroke, hospitalization~     for unstable angina, or coronary revascularization, whichever occurs first, in patients with~     clinically evident cardiovascular disease.~   "
137719|NCT01764620|"~     The purpose of this study is to investigate the effects of muscle fatigue in the scapular~     kinematics of overhead athletes with and without using a kinesio taping technique for~     facilitating lower trapezius function. The hypothesis is that the taping technique could~     compensate for the negative effects caused by muscle fatigue in the scapular kinematics of~     healthy overhead athletes.~   "
137720|NCT01764607|"~     Solid organ transplant recipients (SOTR) have a 3-5x increased occurrence of cancer in~     contrast to the general population with basal and squamous cell skin cancer. The use of~     immunosuppressant or anti-rejection drugs that are needed after SOTR is known to increase the~     risk of developing certain kinds of cancer. The purpose of this study is to find out how well~     Sirolimus (also known as Rapamune) works at treating squamous cell carcinoma in renal~     transplant patients.~   "
137721|NCT01764594|"~     To evaluate safety, tolerability pharmacokinetics and immunogenicity of CDP7657.~   "
137722|NCT01764581|"~     ImmuKnow detects cell-mediated immunity in solid-organ transplant recipients undergoing~     immunosuppressive therapy. Increasing ImmuKnow values indicate a decrease of~     immunosuppression and decreasing ImmuKnow values suggest an increase of immunosuppression.~     The test measures the amount of ATP produced in CD4+ lymphocytes as a biomarker of lymphocyte~     activation. This study uses the ImmuKnow assay to proactively adjust immunosuppressive~     therapy in adult liver transplant recipients to reduce the risk of adverse events~   "
137732|NCT01764451|"~     Cerebral cavernous malformations (CCMs) are clusters of abnormal blood vessels in the brain~     and spine. CCMs can bleed and cause strokes, seizures, and headaches. In some patients, CCMs~     affect the blood brain barrier (BBB). The BBB is the body's separation of blood and its~     contents in the brain from the brain tissue itself. Abnormal leakiness or permeability of~     this barrier can cause disease. We will measure the permeability (leakiness) of the BBB using~     a magnetic resonance imaging (MRI) technique called dynamic contrast-enhanced MRI (DCEMRI).~     The purpose of this study is to look at whether statin medications change the permeability~     (leakiness) of the blood brain barrier in CCM patients. Statin medications are used to lower~     cholesterol levels and prevent heart attack and stroke. In addition, this medication may~     decrease the risk of brain hemorrhage or bleeding in patients with CCM. This study will~     examine whether the permeability of the BBB changes following the administration of~     simvastatin for three months.~   "
137723|NCT01764568|"~     Current Canadian Clinical Practice guidelines emphasize the need for effective psychosocial~     adjuncts to pharmacotherapy for schizophrenia (Canadian Psychiatric Association 2005). This~     randomized control trial seeks to contribute to the body of evidence supporting psychosocial~     treatments by assessing the effectiveness of metacognitive training (MCT) and cognitive~     remediation (CR) at treating the persistent positive and cognitive symptoms of schizophrenia.~     MCT is a therapy designed to improve patient awareness and insight into the cognitive biases~     that are frequently seen in schizophrenia; it has been associated with decreased~     psychopathology (specifically decreased positive symptoms) and improved psychosocial~     function. CR is a therapy designed to improve performance in a variety of neurocognitive~     functions such as attention, memory, and executive functioning; it has been associated with~     improved cognitive and psychosocial functioning. Both MCT and CR will be compared to~     treatment as usual (TAU) as done previously (Kumar er al., 2010; Moritz et al., 2011).~      Hypotheses:~        1. MCT will produce greater change in delusions (severity and conviction) than CR and TAU.~        2. CR and MCT will produce greater change in social/everyday functioning than TAU.~        3. CR will produce greater improvement in basic attention and memory measures relative to~          MCT and TAU.~        4. MCT will produce greater reduction on tasks measuring targeted reasoning biases relative~          to CR and TAU.~        5. CR will increase efficiency of functional networks on a working memory task relative to~          MCT and TAU.~        6. MCT will lead to a greater decrease in the neural response to evidence matches relative~          to CR and TAU.~   "
137724|NCT01764555|"~     This study will investigate the pharmacokinetics of acetaminophen in morbidly obese patients~     versus normal weight patients. Specifically the different metabolic pathways of acetaminophen~     in morbidly obese adults will be investigated; glucuronidation, sulphation and CYP2E1~     (cytochrome P450 2E1) oxidation~   "
137725|NCT01764542|"~     The purpose of this study is to study development of dysplasia in the ileal mucosa among~     patients with Ulcerative Colitis and who previous have hade risk factors for developing~     cellular changes/dysplasia, i.e. previous dysplasia and/or carcinoma in their specimen.~   "
137726|NCT01764529|"~     Cerebral cavernous malformations (CCMs) are clusters of abnormal blood vessels in the brain~     and spine. CCMs can bleed and cause strokes, seizures, and headaches. CCMs are often caused~     by an inherited gene mutation (alteration) called CCM1. There is a wide range of disease~     severity even among family members with this disease, though the natural history has not been~     clearly described for this particular population.~      This study will examine factors that influence disease severity through the collection of~     blood samples, detailed medical histories, physical and neurological exam, and magnetic~     resonance imaging (MRI) of the brain in medical records. The specific goals of this study are~     to:~        1. establish a registry/database of familial CCM cases with detailed clinical data,~        2. perform genetic testing on participant blood samples to identify other genes that may~          influence the development and hemorrhage of CCM lesions, and~        3. determine lesion growth during the study.~   "
137727|NCT01764516|"~     This study was carried out with the purpose of evaluating zinc and selenium levels in serum~     of epileptic patients and compare with normal individuals.~   "
137728|NCT01764503|"~     Adenoma of the ampulla of Vater is rare but represents a large proportion of benign tumors~     occurring in the small intestine. The symptoms are usually non specific or due to~     pancreaticobiliary obstruction . The diagnosis can also be made in asymptomatic patients~     during an upper gastrointestinal endoscopy. Finally, the adenoma can be discovered during a~     screening procedure in patients with Familial Adenomatous Polyposis (FAP).~      It has been demonstrated that ampullary adenomas have a malignant potential mimicking the~     adenoma-adenocarcinoma sequence already described in the colon. So, a complete removal is~     mandatory. The only exception is represented by subnormal ampulla with low grade dysplasia~     (LGD) adenoma discovered during screening follow-up of FAP patients. In these cases the~     situation can be stable during several years leading to simple, annual or biannual~     surveillance. Historically, the treatment was surgical, associated with a high mortality and~     morbidity rate for pancreaticoduodenectomy (PD) and a high recurrence rate for transduodenal~     resection (26 to 43%). Endoscopic papillectomy (EP) represents an alternative for patients~     with a benign or at least non-invasive ampullary tumor. Unlike thermal ablative methods by~     laser photoablation or argon plasma destruction, EP allows adequate histologic evaluation~     especially in case of en-bloc resection. This technique has been increasingly used in the~     last decade with very promising results. Nevertheless the long-term results have mainly been~     reported in retrospective monocentric series.~      We intended to evaluate, in the first large multicenter prospective study, the long-term~     results of endoscopic papillectomy.~   "
137729|NCT01764490|"~     Main objective: to observationally assess the efficacy of different antimicrobials in~     Bloodstream Infection (BSI) due to Enterobacteriaceae producing ESBLs or carbapenemases.~      Specific objectives:~      Bacteraemic infections due to ESBL-producing Enterobacteriaceae:~        -  To demonstrate that β-lactam/β-lactam inhibitors are not associated with worse cure rate~          and mortality than carbapenems after controlling for confounders, both as empirical and~          definitive therapy.~        -  To demonstrate that fluoroquinolones as definitive therapy are not associated with worse~          cure rate and mortality than carbapenems after controlling for confounders.~        -  To demonstrate that empirical cephalosporins in monotherapy are associated with worse~          cure rate and mortality than carbapenems after controlling for confounders in infections~          others than urinary tract infections.~        -  To demonstrate that the association of active aminoglycosides with cephalosporins or~          fluoroquinolines is not associated with worse cure rate and mortality than carbapenems~          after controlling for confounders.~        -  To demonstrate that combination empirical and definitive therapy is not associated with~          better cure rate than monotherapy after controlling for confounders.~        -  For tigecycline, colistin, and fosfomycin, no hypothesis. The objective is to provide~          adjusted estimations of their association with outcome variables in comparison with~          carbapenem monotherapy according to clinical situation and infection.~      Bacteraemic infections due to carbapenemase-producing Enterobacteriaceae:~        -  To demonstrate that combination therapy is associated with worse cure rate and mortality~          than monotherapy after controlling for confounders.~        -  To show that carbapenems are associated with worse cure rate and mortality when used in~          infections other than urinary tract caused by isolates showing MIC <2 µg/mL for imipenem~          or meropenem in comparison to those caused by isolates with higher MIC, after~          controlling for confounders.~        -  To show that colistin used at a dose >6 million IU per day is associated with improved~          outcomes in comparison with lower dose, after controlling for confounders.~   "
137730|NCT01764477|"~     Laboratory studies suggest that the study drug may stop cancer cells from growing by~     affecting an interaction between proteins in the cells referred to as cAMP-response~     element-binding protein and ß-catenin.~      The purpose of this research study is to determine the highest safe dose of study drug that~     may be used when it is given together with a chemotherapy drug to patients with cancer of the~     pancreas.~   "
137731|NCT01764464|"~     Evaluate the analgesic benefit of Gralise® for post-laminectomy pain syndrome (PLPS)~   "
137733|NCT01764438|"~     Gadoxetic acid (Gd-EOB-DTPA, Primovist)-enhanced MRI can affect on BCLC staging during the~     initial staging workups of definite HCC patients with very early or early stage disease, but~     with no suspicious intrahepatic HCC lesions by liver dynamic CT.~   "
137734|NCT01764425|"~     Clinical trial to study the safety tolerability, pharmacokinetics, food effect and~     pharmacodynamics of a new compound P7435 in in healthy, overweight and/or obese subjects~   "
137737|NCT01764386|"~     The purpose of this Phase 3b study is to assess the effects of combination therapy with~     naltrexone SR/bupropion SR (NB) used in conjunction with a comprehensive lifestyle~     intervention (CLI) and in a manner consistent with its intended use after marketing approval,~     on body weight and cardiovascular risk factors compared to the effects of Usual Care in~     subjects who are overweight with dyslipidemia and/or controlled hypertension or obese.~     Subjects in the NB and CLI group are required to undergo an evaluation to continue treatment~     at Week 16. Subjects are to be discontinued from full participation if they do not lose at~     least 5% of their body weight relative to baseline and/or are experiencing sustained~     increases in blood pressure (systolic or diastolic) of ≥10 mmHg above baseline. At Week 26,~     subjects originally assigned to Usual Care switch to treatment with NB and CLI, and subjects~     assigned to NB and CLI continue treatment for the duration of the study (78-weeks treatment~     period).~   "
137738|NCT01764373|"~     This is an amendment to study posting NCT00970060. Based on preliminary results from that~     study is was determined there needs to be a follow-up exercise intervention study. This study~     has two additional aims than the original study. The objectives are to determine is a~     prolonged exercise routine, 16-weeks, paired with refined measures of effectiveness~     positively impact people with diabetic neuropathy.~   "
137739|NCT01764360|"~     Kaposi sarcoma (KS) is an AIDS-related cancer and is the most commonly reported cancer in~     Zimbabwe. If it is found early on, it may be treatable with antiretroviral therapy (ARVs)~     alone and this will improve general well-being and ease of care. It may also be possible to~     avoid use of expensive chemotherapy if the KS is picked up early on in the course of the~     disease. Early KS is often overlooked or not recognized by health professionals. The purpose~     of the study is to learn more about if the level of medical care and treatment provided at~     primary care clinics in Zimbabwe will help people with AIDS-KS do better and maintain their~     health longer. This will be done by monitoring how KS is diagnosed and treated at the primary~     care clinics. Clinics will then have training in how to recognize and treat KS so that they~     can better identify and care for patients with the disease.~   "
137740|NCT01764347|"~     This pilot clinical trial studies magnetic resonance imaging (MRI)-transrectal ultrasound~     (TRUS) fusion image-guided prostate biopsy following radical prostatectomy in patients with~     prostate cancer. Diagnostic procedures, such as MRI-TRUS fusion image-guided prostate biopsy~     may help find and diagnose prostate cancer~   "
137741|NCT01764334|"~     Background: In patients with acute non-ST elevation myocardial infarction (NSTEMI) coronary~     arteriography is usually recommended however visual interpretation of the coronary angiogram~     is subjective. A complementary diagnostic approach involves measuring the pressure drop~     across a coronary stenosis (fractional flow reserve, FFR) with a pressure-sensitive~     guidewire.~      Hypothesis: Routine FFR measurement is feasible in NSTEMI patients and has additive~     diagnostic, clinical and health economic utility, as compared to angiography-guided standard~     care.~      Design: A prospective multi-center randomized controlled trial in 350 NSTEMI patients with ≥1~     coronary stenosis ≥30% severity (threshold for FFR measurement). Patients will be randomized~     immediately after coronary angiography to the FFR-guided group or angiography-guided group~     (FFR measured, not disclosed). All patients will then undergo FFR measurement in all vessels~     with a coronary stenosis ≥30% severity. FFR will be measured in culprit and non-culprit~     lesions in all patients. FFR will be disclosed to guide treatment in the FFR guided-group but~     not disclosed in the 'angiography-guided' group. In the FFR-guided group, an FFR>0.80 will be~     an indication for medical therapy whereas an FFR≤0.80 will be an indication for~     revascularization by percutaneous coronary intervention (PCI) or coronary artery bypass~     surgery (CABG), as appropriate. The primary endpoint is the between-group difference in the~     proportion of patients allocated to medical management compared to revascularization. A key~     secondary composite outcome is the occurrence of cardiac death or hospitalization for~     myocardial infarction or heart failure. Other secondary outcomes include quality of life,~     hospitalization for unstable angina, coronary revascularization or stroke, and healthcare~     costs. Exploratory analyses will also assess the relationships between FFR and angiographic~     lesion characteristics (severity, culprit status). The minimum and average follow-up periods~     for the primary analysis are 6 and 18 months respectively. A secondary analysis with longer~     term follow-up (minimum 3 years) is planned. Screen failures who gave informed consent will~     be entered into a registry.~      Importance: Our developmental clinical trial will address the feasibility of FFR measurement~     in NSTEMI and the influence of FFR disclosure on treatment decisions and health and economic~     outcomes.~   "
137742|NCT01764321|"~     This prospective, post marketing, observational, Noninterventional Study (NIS) is designed to~     compare drug persistence in patients treated with Certolizumab Pegol (CZP) and patients~     treated with any other subcutaneously (sc) administered Tumor Necrosis Factor (TNF)~     inhibitor.~   "
137743|NCT01764308|"~     60 patients receiving isotretinoin will be recruited from the UCLA acne specialty clinic.~     Subjects will be randomized in a 1:1 ratio to receive placebo or omega-3 1200mg twice a day~     for 24 weeks.~   "
137744|NCT01764295|"~     The purpose of this study is to evaluate the efficacy and safety of DWJ1276~   "
137745|NCT01764282|"~     The purpose of this study is to evaluate the effectiveness of reducing HIV transmission among~     sero-discordant couples by applying comprehensive intervention components.~   "
137746|NCT01764269|"~     In this study, the investigators will prospectively assess fever rates in 24-59 month old~     patients during days 0-10 after administration of inactivated influenza vaccine (IIV) or live~     attenuated influenza vaccine (LAIV). Children in one of three study sites who receive these~     vaccines as part of their routine care can enroll in this study if their parent has the~     ability to receive and send text messages. Children enrolled in this study will be observed~     for an eleven day period starting on the day of vaccine administration via a series text~     messages to their parents.~   "
137747|NCT01764256|"~     This study will evaluate 3 doses of a new vaccine for rotavirus infection in healthy adult~     volunteers to determine if it is safe and if the immune systems of healthy adults respond to~     this vaccine.~   "
137748|NCT01764243|"~     The objective of this study is to evaluate the safety and efficacy as assessed by the~     Alzheimers Disease Assessment Scale-cognitive subscale 13-item (ADAS-cog-13) of two doses of~     MT-4666 or placebo administered daily for 24 weeks to subjects with mild to moderate~     Alzheimer's disease.~   "
137749|NCT01764230|"~     Chemotherapy as one of the basic modalities of oncology treatment often leaves permanent~     implications and among the most common is infertility as a result of irreversible gonadal~     damage. This project sets the primary target to verify the protective effect GnRH analogues~     administration to protect ovarian tissue during three different regimens of chemotherapy in~     patients with Hodgkin disease (HD) in reproductive age.~   "
137750|NCT01764217|"~     Observational study based on the routine clinical treatment and diagnostic course, to~     correlate imaging features with outcome objectives. Outcome will evaluated as clinical~     response to the standard treatment and as recurrence and survival in the follow up. The study~     hypothesis is that data extracted form FDG-PETCT used in the routine clinical practice can~     predict outcomes following standard treatment.~   "
137751|NCT01764204|"~     To highlight the incidence of adverse reactions of Qingkailing Injection.~   "
137752|NCT01764191|"~     This study has been designed to provide patients suspected of having cardiac sarcoidosis (CS)~     with a potentially diagnostic 18F FDG PET/CT. CS is difficult to diagnose with currently~     available methods, therefore this project will allow access to 18F FDG PET/CT scanning, which~     may more accurately diagnose the presence of CS. This study will also provide additional data~     to further examine the effectiveness and safety profile of 18F FDG for this condition.~     Accurate and early detection is important to allow for better management of CS and improve~     patient care.~      The purpose of this study is to provide access to 18F-FDG PET/CT imaging in patients with~     clinical suspicion of cardiac sarcoidosis, and to collect additional data about the safety~     and effectiveness of 18F-FDG PET/CT in this patient population~   "
137753|NCT01764178|"~     The purpose of this study is to compare pharmacokinetics between Pitavastatin and Valsartan~     co-administration and Livalo fixed combination drug in healthy male subjects.~   "
137754|NCT01764165|"~     This research is being conducted to examine the effects of nasal insufflation of warm and~     humidified air through a small nasal cannula on sleep, breathing pulmonary function, and~     daytime exercise capability.~   "
137755|NCT01764152|"~     This study assesses the seasonal of influenza vaccine effectiveness in adults hospitalised~     with laboratory-confirmed influenza through a network of hospitals in France~   "
137756|NCT01764139|"~     Vitamin D deficiency has long been linked to musculoskeletal pain, and many other chronic~     disease conditions. Vitamin D is a nutrient that functions as a hormone precursor, and~     wide-ranging health effects are supported by the presence of vitamin D receptors in several~     cell types and tissues of the body (eg, lymphocytes and monocytes, brain, heart, pancreas,~     intestine, and placenta).In addition to its essential role of maintaining bone health,~     hypovitaminosis D has been implicated in the development of serious conditions, including~     diabetes, various types of cancer, and cardiovascular diseases.~      Vitamin D is a unique prohormone that humans obtain in small amount from food, dietary~     supplements and largely by endogenous skin synthesis from 7-dehydrocholesterol with sunlight~     exposure. This endogenous synthesis produces the form vitamin D3 (cholecalciferol).Vitamin D~     deficiency and insufficiency are very common in the UK. Local audit at Chelmsford has shown~     severe deficiency of vitamin D among chronic pain patients.~      The major source of vitamin D synthesis relies on sunlight exposure which is likely to be~     affected by modern lifestyles, which increasingly involve working indoors during daylight~     hours. This may be particularly important when combined with residence in northern latitudes~     and a cloudy climate.The proposed pilot study aims to identify percentage of vitamin D~     deficiency among knee pain patients by investigating eligible patients' blood for '25 hydroxy~     vitamin D'.~      English speaking patients whose knee pain has not been resolved following knee arthroscopy~     are eligible for the study. Study will be carried out at the Broomfield hospital chronic pain~     department.~      Duration will be around 6 months.~   "
137757|NCT01764126|"~     This is an observer-blind, randomised, vaccine-controlled, vaccine trial to determine the~     safety and immunogenicity of a pneumococcal protein vaccine. It will use an age step-down~     approach beginning with adults, then toddlers then infants, with data safety review at each~     stage before stepping down to the next age group. Adults and toddlers will receive the same~     dose of this three-protein (trivalent) vaccine (PcpA, PhtD, and PlyD1 proteins) at 50µg each.~     Infants will then be started at a low dose (10 µg), then medium dose (25µg) then high dose~     (50µg), with safety reviews at each stage before ascending to the next highest dose. Infants~     will also receive concomitant standard EPI childhood vaccines. Safety will be assessed by~     close monitoring beginning on the day of vaccination (day 0) and for the subsequent seven~     days, with recording of solicited and non-solicited adverse events. Immunogenicity will be~     assessed by specific antibody response to the three proteins. The study aims to recruit 280~     study subjects across all age groups.~   "
137758|NCT01764113|"~     This study is designed to study the effect of a family based mindfulness training program~     with special focus on diet and nutrition on weight and cardiovascular risk markers in obese~     adolescents.~   "
137759|NCT01764100|"~     This is a bicentric, prospective, non randomized study. Pediatric and adult patients will be~     treated.~      Rationale: MSC have shown promising effects by reversal of severe therapy-resistant acute~     GvHD. As a common therapeutic line of action is not shared for steroid resistant GVHD, it is~     important to establish the toxicity and the feasibility of preparation and infusion of third~     party MSCs for acute steroid resistant GVHD and acute phases of chronic steroid resistant~     GVHD.~      A total of 10 patients (pediatric and adults) need to be enrolled in the study. Patients who~     present clinical signs of either acute or chronic steroid resistant GVHD will receive by~     intravenous infusion at least two fixed doses of mesenchymal stem cells with 5 to 7 days of~     interval one from the other, derived from HLA unrelated donor different from the HSC donor~     (third party donor) regardless of the rate of HLA mismatch.~      Primary objectives are to establish the feasibility and the toxicity of preparation and~     infusions of third party MSCs for the treatment of steroid resistant acute and acute phases~     of chronic grade II-IV GVHD.~      Secondary objectives are:~        1. To document the efficacy of MSC infusion in steroid resistant acute and acute phases of~          chronic GVHD grade II-IV.~        2. To document the rate of GVHD recurrence in MSCs infused patients.~        3. To document relapse of hematological malignancies post MSC infusions in patients~          undergoing MSCs treatment for steroid refractory GvHD.~        4. To document the overall survival of MSC infused patients for steroid refractory GvHD.~   "
137760|NCT01764087|"~     The primary objective of this study is to determine the maximum tolerated dose (MTD) of~     KX2-391 in Combination with paclitaxel in Phase I, and to evaluate the efficacy of KX2-391 in~     combination with paclitaxel in patients who are diagnosed as gastric and breast cancer,~     respectively in Phase II.~   "
137771|NCT01763944|"~     No treatments have been shown to slow prostate cancer progression after radical~     prostatectomy. We hypothesize that a carbohydrate restricted diet will slow prostate cancer~     growth. A total of 60 men with a rising prostate-specific antigen (PSA) after failed primary~     treatment will be recruited and randomized to either a low-carbohydrate diet (<20 grams~     carbohydrates/day) or a no-diet control (standard of care) for 6 months. The primary outcome~     is PSA doubling time.~   "
137772|NCT01763931|"~     The purpose of this study is to learn what effects digoxin may have on human breast cancer~     tissue.~   "
137761|NCT01764074|"~     Individuals with bipolar disorder (BD) experience extreme mood swings, or episodes of~     depression and (hypo)mania. These episodes are associated with poor functioning, worse course~     of illness, and high rates of suicidality. It is estimated that between 25 to 65% of~     individuals with BD attempt suicide and 4 to 19% of individuals with BD eventually die by~     suicide. Sleep disturbance has been identified as a primary prodromal as well as causal~     symptom of mood episodes and recently, has been found to be associated with higher rates of~     suicidal ideation and behavior. Given the role that sleep may have in mood stability and~     suicidality in BD, it seems imperative to further understand the association of sleep and~     suicide and how sleep interventions may be useful to reduce suicidality in BD. Thus, the~     primary aim of this study is to use an innovative home sleep monitoring device, or the Embla,~     to examine the association of sleep and suicidality in adult outpatients with BD. The Embla~     is unique in that it is a non-invasive device that can characterize sleep profiles by~     measuring the degree of sleep fragmentation and percentage of rapid eye movement (REM) sleep.~     The study duration is five to six weeks such that patients wear the Embla device for Week 1,~     participate in a brief sleep intervention for suicide during Weeks 2 and 3, and 4, and then~     wear the Embla device for one more week (Week 5). This intervention consists of three, 60-min~     sessions and utilizes cognitive-behavioral therapy strategies (e.g., psychoeducation,~     cognitive re-structuring, problem solving, behavioral activation) to improve sleep~     disturbance. The investigators expect that individuals at study entry with more sleep~     disturbance (as measured by the Embla) will report more suicidal ideation and behaviors. The~     investigators also hypothesize that from pre- to post-intervention, individuals will report~     less sleep disturbance as well as suicidal ideation and behaviors. Data from this research~     has immediate and practical implications for providers and their patients as it the first~     examination of sleep phenotypes and suicide in a high risk population as well as to explore~     the association of improvements in sleep with suicidality.~   "
137762|NCT01764061|"~     The purpose of this study is to validate that single units of RBCs collected by the~     Haemonetics MCS®+ 8150 system using LN832 disposable sets during an interrupted double red~     cell collection protocol meet all in vitro FDA requirements for non-leukoreduced red blood~     cells, and to provide data to support the 510(k) clearance of the MCS®+ 8150 system using~     LN832 disposable sets for this intended use.~   "
137763|NCT01764048|"~     Cesarean deliveries are prevalent. Unlike other operations, quick recovery is required for~     the mother to nurture the newborn child and establishing an appropriate mother-child bonding.~     Therefore, effective pain management is crucial. In this study we would like to compare~     between two pain relievers' administration protocols: (1) pain relievers' administration in~     fix protocol (type of medications, dose and intervals) or (2) pain relievers' administration~     following demand (the same type and doses, however, medications will be given only following~     patient's request).~      The primary outcome will be patient satisfaction, pain control and the necessity of~     additional medications (rescue doses).~      The protocols will be used for the first 48 hours following surgery.~   "
137764|NCT01764035|"~     The investigators propose to investigate the efficacy of a brief (4-session) Body Scan (BS)~     meditation intervention for individuals with bipolar I disorder with insomnia (i.e.~     difficulties falling or staying asleep). The investigators will compare the Body Scan~     intervention with a 4-session brief supportive psychotherapy (SP) intervention. The~     investigators hypothesize that the Body Scan will improve objective sleep quantity and~     quality.~   "
137765|NCT01764022|"~     BCD-022-02 is a double-blind randomized clinical trial comparing efficacy of BCD-022 (INN:~     trastuzumab) and paclitaxel to Herceptin and paclitaxel in HER2-positive metastatic breast~     cancer with pharmacokinetics substudy. The purpose of the study is to demonstrate the~     non-inferiority of efficacy and safety of BCD-022 compared to Herceptin. Also study includes~     pharmacokinetics assessment.~   "
137766|NCT01764009|"~     The objective of the present trial is:~        -  to determine the dose limiting toxicity (DLT), maximal tolerated dose (MTD) and~          recommended phase 2 dose (RP2D) of intramuscular electrotransferred Plasmid AMEP in~          patients with advanced or metastatic melanoma.~        -  to determine the local and general safety of intramuscular electrotransferred Plasmid~          AMEP~        -  to evaluate the efficacy of intramuscular electrotransferred Plasmid AMEP~   "
137767|NCT01763996|"~     The purpose of this study is to assess the effect of febuxostat on coronary artery flow in~     patients with coronary artery disease.~   "
137768|NCT01763983|"~     High levels of psychological stress have been reported by 90% of patients with MS~     experiencing disease exacerbation, and approximately 39% of those with more stable disease~     course. These stress levels are comparable to patients with a clinical diagnosis of major~     depression. Cognitive dysfunction affects approximately 40% of community surveyed MS~     patients, and stress may exacerbate the cognitive burden. Studies have shown that Cognitive~     Behavior Therapy (CBT) is effective in treating psychological stress. Studies have also shown~     that exercise is beneficial to mood and cognitive function. Therefore the proposed study will~     test the comparative benefits of combining CBT and Exercise as an intervention for stress and~     cognitive dysfunction in MS subjects. The 2 active treatment conditions will be compared with~     a waitlist control condition.~      There are 4 broad aims to this study: 1) to compare the relative efficacy of CBT, Exercise,~     and CBT-Exercise for stress in MS, 2) to examine the extent to which neuropsychological~     features of stress and MS, especially working memory and executive functioning, improve~     following treatments, 3) to determine the extent to which neuropsychological factors are~     associated with successful treatment response and improved quality of life, and 4) to~     determine if combined CBT-Exercise confers greater benefits on measures of stress and~     neuropsychological functioning compared with Exercise alone.~      The study hypotheses are: 1) All active treatment conditions will lead to significantly~     greater improvement on measures of stress at post-treatment and follow-up compared to~     waitlist controls, 2) Combined CBT-Exercise will lead to comparatively greater symptom~     reduction compared to all other conditions at post-treatment and follow-up assessments on~     measures of stress, 3) All active treatment conditions will lead to significant improvement~     in neuropsychological functioning (particularly measures of working memory and executive~     functioning) at post-treatment compared to controls, and 4) Combined CBT-Exercise will lead~     to greater improvement in neuropsychological functioning compared to all other conditions at~     post-treatment.~      The study design allows for examination of the potential additive benefits of CBT and~     Exercise to usual therapy for patients, and its feasibility as a viable treatment model for~     MS outpatient clinics and community-based intervention programs. This study will shed light~     on the treatment of sub-threshold symptoms that are strikingly common in MS population, but~     often overlooked in favour of more concrete diagnoses (e.g. major depression disorder). This~     proposed study will also be the first to determine whether evidence-based non-medical~     treatments for stress and mood disturbances in MS reduce underlying cognitive substrates~     associated with the illness and known to be exacerbated by stress.~   "
137769|NCT01763970|"~     The SBRT (stereotactic body radiation therapy) literature focuses on clinical outcomes in the~     adult population. However, SBRT (stereotactic body radiation therapy) has a particularly~     strong rationale for application in pediatrics given that high biologically effective doses~     have been shown to increase control in histologies, such as sarcoma, which are common in the~     pediatrics population (11,25). With stereotactic radiation therapy techniques, a reduction in~     normal tissue dose surrounding the target lesion of interest may also be accomplished~     resulting in lower toxicity. Given that pediatric patients with sarcomas, presenting with~     limited metastases in lung and bone, are still considered to be a curable population with~     aggressive local therapy, SBRT could have a significant impact on outcomes in oligometastatic~     patients who may be otherwise unresectable (25-28).~   "
137770|NCT01763957|"~     The Investigators decided to examine whether the Paula method is more effective than Pelvic~     Floor Muscle Training (PFMT) in terms of urinary leakage amount, as it measured by pad test~     in menopause women without an hormonal therapy. In addition to the pad test and two urinary~     incontinence questionnaires, we will use other assessment tools such as; quality of life and~     sexual function which have been found to correlate significantly with pad test results. These~     results may indicate that menopausal women with Stress Urinary Incontinence may be more~     successful controlling incontinence if they will practice the Paula method as compared to~     PFMT.~   "
137774|NCT01763905|"~     The primary objective was to evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab~     every 2 weeks (Q2W) and monthly (QM), compared with ezetimibe, on percent change from~     baseline in low-density lipoprotein cholesterol (LDL-C) in hypercholesterolemic adults unable~     to tolerate an effective dose of a statin (HMG-CoA (5-hydroxy-3-methylglutaryl-coenzyme A)~     reductase inhibitors).~   "
137775|NCT01763892|"~     The aims of this study explore the relationships between cerebral vasospasm, apolipoprotein-E~     (apo-E) genotype, physiologic symptoms, and neurocognitive outcomes that may either intensify~     or ameliorate secondary injury, for children with a traumatic brain injury. Exploring the~     apo-E genotype will help us know if injury response is altered in certain children and will~     aid in developing interventional approaches.~   "
137776|NCT01763879|"~     The use of pressure controlled ventilation (TV) during one lung ventilation (OLV) for~     thoracic surgery is associated with comparable oxygenation with volume controlled ventilation~     (VCV) with added benefits of decreasing airway pressures and shunt fraction. The later may~     improve the right ventricular (RV) function during OLV. We postulate that the use of PCV~     during OLV for thoracic surgery would preserve RV function than during VCV. After local~     ethics committee approval and informed consent, we will randomly allocate 28 patients~     scheduled for elective thoracic surgery OLV to randomly crossed from PCV to VCV mode (n= 14~     for each) during with VT of 6 mL/kg, I: E ratio 1: 2.5, PEEP of 5 cm H2O, recruitment~     maneuvers and respiratory rate will be adjusted to maintain normocapnia. Intraoperative~     changes in the right ventricular function (peak systolic and diastolic tricuspid annular~     velocity (TAV), end-diastolic volume (EDV), end-systolic volume (ESV), and RV fractional area~     changes (RV-FAC)), hemodynamic and oxygenation parameters, peak and plateau airway pressures,~     compliance will be recorded.~   "
137777|NCT01763866|"~     The primary objective was to evaluate the effect of 12 weeks of evolocumab administered~     subcutaneously every 2 weeks (Q2W) and monthly (QM) when used in combination with a statin,~     compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol~     (LDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia.~   "
137778|NCT01763853|"~     The need for fluid resuscitation (FR) in ICU patients with acute respiratory distress~     syndrome (ARDS) is common. Indeed, relative or absolute hypovolemia is a common phenomenon~     that the intensivist must recognize early and treat promptly. Fluid challenge may have~     adverse side effects associated with fluid administration. The diffusion within the~     interstitial space may favor edema formation and cause cardiac dysfunction by volume~     overload. Edema formation is global and may specifically alter pulmonary alveolar epithelial~     integrity, leading to enhanced alveolar edema and impaired gas exchange.~      Currently, two types of fluids are frequently used, crystalloids and colloids. Among colloids~     and compared to crystalloids, albumin has the theoretical advantage of causing greater volume~     expansion.~      We hypothesized that a fluid resuscitation therapy with albumin generates less pulmonary~     edema than a fluid resuscitation therapy with crystalloids.~      The aim of our study is to compare alveolar fluid clearance, as a marker of alveolar edema~     fluid resorption, in 2 groups of patients: those treated with albumin and those treated with~     crystalloid.~   "
137779|NCT01763840|"~     The research protocol aims to compare the utility of contrast enhanced abdominal sonography~     with computerized tomography in the evaluation of children with blunt abdominal trauma.~     Hemodynamically stable children ages 7-18 who are transferred to Children's Hospital on the~     trauma service with a CT scan of abdomen & pelvis already performed at the referring~     institution will be identified by the trauma service as eligible for inclusion.~      The ultrasounds will be performed by one of two Attending Radiologists involved in the study.~     The contrast being used for the study is Optison (GE Healthcare Inc, Princeton, NJ), which is~     an injectable suspension of Perflutren Protein-Type A Microspheres. This has been used in~     echocardiography as well as abdominal ultrasonography for evaluation of pediatric abdominal~     and pelvic solid tumors. The contrast enhanced ultrasound will be performed by radiologist.~     Contrast enhancement only lasts for 3-5 minutes per injection, therefore Optison will be~     redosed up to 2 additional doses for the completion of the ultrasound. Vital signs will be~     monitored for 30 minutes after the contrast agent is given and any adverse reactions will be~     recorded. Adverse reactions to Optison have occurred within this time frame in the~     literature. Subsequent medical care will be as indicated per the clinical practice guideline.~   "
137780|NCT01763827|"~     The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneous (SC)~     monotherapy every 2 weeks (Q2W) and monthly (QM), compared with placebo and ezetimibe, on~     percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with a~     10-year Framingham risk score of 10% or less.~   "
137781|NCT01763814|"~     Patients scheduled to have a surgery for Total Knee Arthroplasty will be assigned to one of~     three groups, each group will use a different approach using the ultrasound to guide the~     femoral nerve block as part of their treatment for controlling pain post-operatively.~   "
137782|NCT01763801|"~     Intravenous electrocardiographic guidance (IVECG) is a safe, reliable and accurate technique~     to correctly position the catheter tip. The investigators sought to evaluate the superiority~     of the P-maximal (P-max) wave compared to the P-submaximal (P-submax) wave in obtaining a~     more correct, safer and longer lasting device placement, with a lower incidence of~     complications and secondary misplacement.~   "
137783|NCT01763788|"~     The purpose of the Phase 1b portion of the study is to investigate how the body tolerates~     necitumumab, in combination with gemcitabine and cisplatin chemotherapy as first line~     treatment in participants with Stage IV squamous NSCLC and to determine the recommended dose~     for the subsequent Phase 2 portion of the study.~      The purpose of the Phase 2 portion of the study is to evaluate the efficacy of necitumumab in~     combination with gemcitabine and cisplatin chemotherapy in participants with Stage IV~     squamous NSCLC in a first-line setting.~   "
137784|NCT01763775|"~     The clinical protocol of the clinical testing of this device:~        1. Objective of the test: To verify the functions and efficiency of devices.~        2. Test methods and procedures: Comparison Test.~        3. Device Under Test (DUT): Transtek Body Fat Analyzer, Model: GBF-1251-B, BF-1255-B,~          BF-1256-B, and GBF-1257-B.~        4. Comparison device: Transtek, Glass Body Fat Analyzer, GBF-950-D.~        5. Study endpoints: DUT and the comparison device are substantial equivalence.~        6. Statistical methodology used: Description of statistical methods.~   "
137787|NCT01763736|"~     The objective of this research study is to assess the effects of music on patients'~     experience in the Intensive Care Unit (ICU). The hypothesis of this study is that patients~     who receive music therapy will report a reduction in negative recollections and experiences~     while on mechanical ventilation and will require fewer pharmacologic agents to maintain their~     sedation.~   "
137788|NCT01763723|"~     This studies was designed to investigate the importance of skin type and UV-exposure on side~     effects after exposure to an Intense Pulsed Light Home-use device.~      21 healthy subjects will receive 8 UV-exposures on one buttock and subsequently three weekly~     IPL-exposures.~   "
137789|NCT01763710|"~     Nanomedicines are currently being developed in the treatment of cancer due to their~     pharmacological advantages over traditional formulations; they provide a shorter infusion~     time and lower risks of hypersensitivity reactions associated with commonly used solvents.~      Nab-paclitaxel is a nanoparticle albumin-bound particle form of paclitaxel that is thought to~     exploit natural albumin pathways to enhance the selective uptake and accumulation of~     paclitaxel at the site of the tumour, thus reducing its diffusion to normal tissues.~      Nab-paclitaxel has been approved for the treatment of metastatic breast cancer patients who~     have failed first-line treatment for metastatic disease and for whom standard,~     anthracycline-containing therapy is not indicated.~      SPARC is a cysteine rich acid protein that is overexpressed in a broad proportion of solid~     tumours. Expression of this protein could sensitize tumour cells to antitumor activity of~     Nab-paclitaxel, due to its union through albumin-binding to this protein.~      First-line clinical trials have been developed with different Nab-paclitaxel regimens and~     also in combination with different chemotherapies and trastuzumab, showing a high level of~     efficacy.~      Toxicity profile of Nab-paclitaxel is well characterized with significantly less~     haematological toxicities compared with conventional paclitaxel.~      Nab-paclitaxel derived grade III neuropathy is short-lasting and more reversible than~     conventional paclitaxel-derived neuropathy, probably due to absence of Cremophor solvent, or~     due to paclitaxel itself.~      However there is still a lack of clinical and physiological characterisation of~     Nab-paclitaxel induced neuropathy.~      The current used tools for early detection and continuous evaluation of neurotoxicity are not~     optimal. Most used toxicity scales are limited, as they do not provide a detailed information~     of the severity of the neuropathy, its impact on quality of life, or physiopathology~     mechanisms.~      In addition, an inter-individual variability exists in terms of neurotoxicity predisposition~     when taxanes are used; it could be related to polymorphic differences in genes implicated in~     transport and metabolism of these drugs.~   "
137790|NCT01763697|"~     This study will investigate the effects of acute morphine administration on taste acuity and~     how much a person eats. It is hypothesized that there will be a dose dependent decrease in~     taste acuity and dose dependent increase in food intake associated with acute morphine~     administration. Knowledge from this study will impact the future of feeding behavior and~     obesity research in the general population. Results will also promote exploration of the~     long-term effect of opioid abuse on taste acuity and feeding behavior in substance abusing~     populations.~   "
137791|NCT01763684|"~     This study will compare alignment criteria in the Oxford Partial Knee using conventional~     instrumentation and Signature Custom Guides in order to determine if the use of the Signature~     Custom Guides results in a higher percentage of knees achieving optimal alignment. The study~     will also examine outcomes with high volume surgeons (>30 cases/year) and low volume surgeons~     (<10 cases/year).~   "
137792|NCT01763671|"~     The study objective is to evaluate the efficacy of paclitaxel-bevacizumab comparing to~     docetaxel.~      Docetaxel is a standard treatment of 2nd or 3rd line in lung cancer. It was validated by~     numerous clinical trials but sometimes toxicities are difficult to manage.~      Bevacizumab is an antiangiogenic treatment which was validated by numerous clinical trials in~     association with platinum in first ligne. Different clinical and preclinical data suggest~     that there could exist a synergy between paclitaxel and bevacizumab. This association is~     already used in metastatic breast cancer, it permits almost to double the response rate and~     progression free survival. In lung cancer, the association was evaluated by two retrospective~     studies which demonstrated a benefit with a favourable safety profile.~   "
137793|NCT01763658|"~     Oxidative stress occurs as a result of increased activity of free radical-producing enzymes,~     decreased activity of free radical-removing enzymes, and insufficient levels of antioxidants.~     The most sensitive molecules to oxidation are lipids. Loss of cell membrane elasticity,~     increased cell fragility, and a shortened cellular life span results from oxidation of cell~     membrane lipids.~   "
137794|NCT01763645|"~     BCD-021-02 is a double-blind randomized clinical trial comparing efficacy of BCD-021 (INN:~     bevacizumab) and paclitaxel + carboplatin to Avastin and paclitaxel + carboplatin in~     inoperable or advanced non-squamous NSCLC patients with pharmacokinetics substudy. The~     purpose of the study is to demonstrate the non-inferiority of efficacy and safety of BCD-021~     compared to Avastin. Also study includes pharmacokinetics assessment.~   "
137795|NCT01763632|"~     Thirteen hospitals in China will participate in the study, which aims to provide data on~     transcutaneous bilirubin (TcB) levels for the first 168 hr after birth in term and~     late-preterm neonates, and develop an hour-specific TcB nomogram.~      The investigators hypothesize that the hour-specific TcB nomogram can predict neonatal~     hyperbilirubinemia in term and late-preterm Chinese infants, and plan appropriate follow-up~     for hyperbilirubinemia in newborns.~   "
137796|NCT01763619|"~     This study will collect clinical and radiographic data on the Freedom Cervical Disc to~     monitor the device's safety and performance as part of a post-market evaluation.~   "
137797|NCT01763606|"~     Patients with cancer who develop stroke are at high risk for future strokes or other clotting~     events. These patients are routinely treated with medicines that thin their blood, including~     enoxaparin or aspirin. However, it is unclear which medicine is best and whether these~     medicines can be adequately studied in a clinical trial.~      The purpose of this Phase I/II study is to determine if a clinical trial of different blood~     thinners in patients with cancer and stroke is possible. In addition, the study aims to~     compare the effects, good and/or bad, of enoxaparin with those of aspirin on patients with~     cancer and recent stroke.~   "
137798|NCT01763593|"~     To evaluate the safety and surgical effectiveness of surgical blades (Aurosleek) made by~     Aurolab.~   "
137799|NCT01763580|"~     To compare the therapeutic effect of tacrolimus in combination with low-dose corticosteroid~     with high-dose corticosteroid alone in patients with minimal-change nephrotic syndrome.~   "
137800|NCT01763567|"~     The purpose of this study is to assess safety and device performance of the Medtronic~     Hospital Glucose Management System (HGMS) for up to 72-hours.~   "
137801|NCT01763554|"~     Retrospective review of the medical files of 115 patients with neuroendocrine tumours who~     were treated with Lutetium-177 DOTA-TATE under Health Canada's Special Access Programme (SAP)~     at the Cross Cancer Institute between January 2010 and April 30, 2014. Efficacy, safety, and~     other relevant data will be collected to support a separate clinical trial application.~   "
137802|NCT01763541|"~     There is gender dimorphism in cardiovascular risk, with men at higher risk than women.~     However, the fundamental basis for the protective effect of female sex remains unclear.~     Recent data implicate the natriuretic peptide (NP) system as an important determinant of~     blood pressure. Also, NP levels are twice as high in women of reproductive age than in men,~     and gonadal steroids are important determinants of circulating NPs. These are the marked, but~     poorly understood differences in the NP status between men and women. The investigators~     hypothesize that gonadal steroids regulate NP release, specifically that testosterone~     inhibits and estrogen activates the NP axis, leading to differences in both resting NP levels~     and dynamic responses of the NP, RAAS, and kidneys to acute and chronic salt loading.~     Understanding the basis for gender differences in NP function should provide important~     insights regarding mechanisms underlying hypertension in men versus women.~   "
137803|NCT01763528|"~     The investigators aimed to determine the effects of HP diet on CVD risk factors and hs-CRP~     among overweight and obese women.~   "
137804|NCT01763515|"~     Knee osteoarthritis is a common problem with the disease prevalence increasing with advancing~     age. This study will be performed in the purpose of determination the effects of laterally~     wedged insoles on symptoms reduction of patients with knee osteoarthritis.~   "
137805|NCT01763502|"~     Recent evidence shows that early childhood is a critical period for investments in human~     capital and that micronutrient deficiency and inadequate stimulation are major causes of~     impaired child development in poor countries. These findings have increased interest in~     promoting nutrition interventions and preschool participation during early childhood.~     Transfers to households linked to preschool participation have the potential to improve~     nutrition and cognitive outcomes in young children. Receipt of transfers may induce~     improvements in diet quality and greater preschool participation, enhancing both nutrition~     and stimulation. However, there is limited evidence on the impacts of such programs, all of~     it from Latin America. There is also no evidence on the relative impact of different transfer~     modalities linked to preschool participation.~      This study is a cluster-randomized controlled evaluation of a transfer program linked to~     preschool participation. The transfer program, administered by the World Food Programme,~     provides food or cash transfers to children aged 3-5 years enrolled in preschools at~     baseline. The preschools, operating in the Karamoja sub-region of Uganda, are supported by~     UNICEF and managed by District representatives of the Government of Uganda. The food~     transfers consist of multiple-micronutrient-fortified corn soy blend (CSB), oil, and sugar,~     totaling approximately 1200 calories per day per child and including 99% of iron~     requirements. Cash transfers equal the estimated value of the food basket if purchased in the~     market. Randomization into the food treatment, cash treatment or control was done across 98~     preschools, referred to as Early Childhood Development (ECD) centers. The intervention period~     was from February 2011 to May 2012 and included distribution of transfers on a~     six-to-eight-week cycle. A longitudinal (panel) survey of households with children aged 3-5~     years at baseline was conducted before exposure to the transfers and 18 months later. The~     randomized design of this effectiveness study and the panel nature of the data allow for a~     rigorous field trial in which impacts on nutrition and cognitive outcomes can be assessed and~     compared across modalities.~      We examine the impacts of the two transfer modalities, cash transfers or~     multiple-micronutrient-fortified food transfers, linked to preschool enrollment, on child~     nutrition and cognitive development. In addition, we explore potential mechanisms through~     intermediate impacts on food intake and participation in preschools.~      The key research objectives are to assess the following:~        1. Impacts on targeted groups: Assess the effects of cash or food transfers on nutrition~          and cognitive outcomes in children aged 3-5 years at baseline and explore pathways for~          these effects.~        2. Optimal program design: Assess the differential impacts of a program in which children~          are provided multiple-micronutrient-fortified food transfers linked to preschool~          enrollment compared with one in which they are given the equivalent value of cash~          transfers linked to preschool enrollment.~   "
137806|NCT01763489|"~     Background: The ASSIST tool is a graphical tool to represent and evaluate the applicability~     of a surgery trial to improve the translation of research to practice.~      Objective: To evaluate the impact of the ASSIST tool on the interpretation of the~     applicability of randomized controlled trials (RCTs) in the field of digestive cancer~     surgery.~      Design: This study is a randomized controlled trial with two parallel arms. Participants:~     Surgeons who contribute to the assessment of manuscripts as experts (peer-reviewer) for~     international scientific journals of surgery (Annals of Surgery, Archives of Surgery,~     Gastrointestinal Surgery World Journal of International Journal of Surgical Oncology).~      Intervention: Surgeons will be randomized into 2 groups. A group that will evaluate a case~     vignette (synopsis) of a randomized trial in surgery, and the other group that will evaluate~     the same case vignette with the representation of the external validity of the trial with~     ASSIST tool.~      Outcome measures: Participants will indicate on a numeric scale range from 1 to 10 if they~     feel able to judge the applicability of the trial for 1) patients, 2) centers, 3) surgeons~     and 4) intervention.~      Sample Size: 28 case vignettes with randomized trials and their ASSIST tool have been~     developed and evaluated. The inclusion of 130 participants (65 per arm) is required.~   "
137807|NCT01763476|"~     There is both a poor life expectancy and a poor prognosis of limb salvage in those patience~     with stenoses or occlusions of the lower limb (TASC Consensus). To date only a small number~     of these patients could be helped through medication or surgery. In fact within the first~     year following diagnosis of a critical limb ischemia 25% of patients lose their leg and 90%~     have to undergo a percutaneous transluminal angioplasty (PTA) or bypass surgery. Using PTA~     for treatment of long infrapopliteal artery lesions, stenosis reoccurs in 70% to 80% of cases~     3 months after index procedure. Even the use of drug-eluting balloons leads only to 1-year~     primary patency rates up to 30%.~      The primary objective of this study is to compare the performance of atherectomy followed by~     a drug-coated balloon angioplasty over drug-coated balloon angioplasty alone in long de-novo~     infrapopliteal lesions in a prospective, single-center, randomized clinical trial.~   "
137808|NCT01763463|"~     Pneumonia remains an important cause of morbidity and mortality in older adults with~     obstructive lung disease. Risk factors for pneumonia, including episodes associated with a~     hospital admission, have been extensively characterized in clinical trials and observational~     studies of patients with COPD, and include older age, lower predicted FEV1 (<50%), prior COPD~     exacerbations, dyspnea , normal to low body mass index (<25), current smoking and certain~     co-morbid conditions (e.g. dementia). The use of inhaled corticosteroids (ICS) has also been~     identified, as associated with an increased risk of pneumonia in patients with COPD.~      The primary objective of this study is to estimate the magnitude of known risk factors and~     the outcomes of pneumonia requiring hospitalization and the potential effect modification of~     these risk factors by ICS use. The primary endpoints will be severe pneumonia, defined as~     community-acquired pneumonia (CAP) resulting in hospitalization and/or death and~     hospital-acquired pneumonia (HAP) diagnosed after two days in the hospital. As a secondary~     endpoint, CAP that did not result in hospitalization or death will be examined. As a~     secondary objective, we will describe characteristics for those patients who develop~     pneumonia requiring hospitalization compared to those with pneumonia not requiring admission.~      This study will use the General Practice Online Database (GOLD), formerly referred to as the~     General Practice research Database (GPRD), a primary care electronic medical record database.~      A new user cohort will be defined among patients with COPD who are 45 years and older in the~     United Kingdom. Patients will be considered a new user of ICS-containing medications if they~     had not received a prescription for an ICS-containing medication in the prior year. The~     comparator treatment group will be new users of long-acting bronchodilators (LABD), including~     long-acting beta-agonists (LABA) or long-acting antimuscarinics (LAMA). In the one year~     washout period, all new users could not have either ICS-containing medications or LABD.~      Prior to conducting the analysis, feasibility analyses will be conducted to evaluate of the~     number of pneumonia events and the number of new users separately to examine the available~     precision based on the study design.~      Patients will be followed from the date of their first eligible prescription (Cohort Entry~     Date) until the earliest of the following: date of study end point (first pneumonia event of~     interest), date of treatment end (up to 60-day gap allowed for each inhaler), date of~     transfer to a new practice, date of ICS initiation (among LABD new users), death or study end~     (end of available data). As part of the primary analysis, patients will be examined for their~     first severe pneumonia (severe CAP, HAP). As a secondary analysis, time to non-severe CAP~     will be examined. Incidence rates of the pneumonia outcomes will be calculated as the number~     of patients experiencing an event divided by the person-years at risk.~      Multivariable analysis will be performed using Cox proportional hazard model with adjustment~     for confounders and medication exposure. To adjust for differences confounding by severity~     due to differences in prescribing between ICS-containing medications and LABD, propensity~     scores (PS) will be utilized using inverse probability of treatment weighting (IPTW). The~     propensity score will be estimated to model the probability of a patient receiving~     ICS-containing medication prescription versus receiving a LABD prescription given a patient's~     observed set of baseline covariates.~      Effect modification (statistical interaction) will be evaluated based on available theory and~     include ICS medication use by known risk factors for pneumonia (BMI<21, BMI 21-24.9, BMI ≥25,~     age, GOLD stage III/IV, MRC dyspnea score ≥4, history of pneumonia diagnosis, current smoking~     status, social deprivation quartiles). Additional interactions may be evaluated.~      To test proportionality of the hazard functions, model diagnostics will be performed.~      To compare severe pneumonia with non-severe pneumonia in patients with COPD, characteristics~     of patients experiencing non-severe CAP vs. severe CAP or HAP will be tabulated. To assess~     differences between treatments, clinical and patient characteristics will be compared using~     the chi-square tests or Wilcoxon tests for categorical or continuous data, respectively.~     Severe CAP and HAP may be combined. Modeling of clinical and patient characteristics may be~     considered using logistic regression using CAP vs. severe CAP and then with severe CAP vs.~     HAP.~      Additional analysis or adjustments to the analytic or modeling strategy will be performed if~     the data warrants. A more detailed modeling strategy, including generation of the propensity~     scores and Cox modeling, will be created in a separate analysis plan. Adjustments to the a~     priori plan will be described in the final study report.~   "
137809|NCT01763450|"~     A multi-center, non-random, open study ,to observe efficacy and safety of bevacizumab plus~     Oxaliplatin based multidrug chemotherapy as conversion therapy for patients with previously~     untreated unresectable liver metastases from colorectal cancer.~   "
137810|NCT01763437|"~     The investigators propose a study to investigate the role of tetracycline injection into~     chalazia versus observation alone. The investigators hypothesize tetracycline injection will~     result in a significant decrease in lesion size when compared to observation alone.~   "
137811|NCT01763424|"~     This study will determine if combination of topical calcipotriol and nicotinamide is more~     effective than calcipotriol alone in treatment of psoriasis.~   "
137812|NCT01763411|"~     This retrospective study comprised patients with cataract, corneal astigmatism, and~     motivation for spectacle independence. In all cases, a multifocal and monofocal Intraocular~     Lens was been implanted in the capsular bag. Three months postoperatively, distance,~     intermediate, and near visual acuities; spherical equivalent; residual refractive~     astigmatism; defocus curve; and contrast sensitivity was evaluated. A patient-satisfaction~     and visual phenomena questionnaire was also been administered.~   "
138002|NCT01760941|"~     This is a survey study to evaluate the feasibility and effectiveness of an affordable, $400~     flat rate, same-day consultation, simulation, and delivery of a single fraction of palliative~     radiation therapy for patients with symptomatic bony metastatic disease who are currently~     enrolled in hospice. Treatment planning and delivery of palliative radiotherapy will utilize~     standard of care techniques.~   "
137813|NCT01763398|"~     The domestic standards of G-CSF permit the use of the G-CSF only when the ANC(absolute~     neutrophil count) drops to 1,000/uL or below. Therefore it is impossible to inject the G-CSF~     in order to prevent neutropenia. However, 'the 2006 Update of Recommendations for the Use of~     White Blood Cell Growth Factors: An Evidence-Based Clinical Practice Guideline(J ClinOncol~     2006; 24:3187-3205)' and the 'NCCN Guideline' have revealed that as a precaution, it is~     appropriate to inject the G-CSF to the non-Hodgkin's lymphoma patients with high-risk factors~     under the anticancer treatment of CHOP-21 Rituximab before the number of neutrophils~     decreases. Thus, it is intended to analyze the risk factors of febrile neutropenia in a~     high-risk group of non-Hodgkin's lymphoma patients with a neutropenic fever who receive the~     CHOP-like regimen and primary G-CSF prophylactic therapy every three weeks. (The definition~     of neutropenic fever is a fever over 38.3 degrees C or continuous fever lasting longer than 1~     hour over 38 degrees C with the number of neutrophil ≤ 500/uL or neutrophil ≤ 1,000/uL in~     case of expected decline to ≤ 500/uL within 48 hours.)~   "
137814|NCT01763385|"~     This project is aim to explore non-increased-intracranial-pressure symptomatic brain~     metastases of NSCLC, and if the OS of secondary brain radiotherapy after recurrence with~     Erlotinib is better than Erlotinib with concurrent brain radiotherapy. Treatment group are~     treated with Erlotinib until brain tumor progression, then gave brain radiotherapy, and~     continued to take Erlotinib till extracranial lesions progression. Control group are~     Erlotinib with concurrent brain radiotherapy, and continued to take Erlotinib after~     radiotherapy until recurrence or termination for other reasons.~   "
137815|NCT01763372|"~     The purpose of this study is to investigate the functional effects of arthroscopic iliopsoas~     release. To complete this aim, we will recruit patients who have undergone arthroscopic~     iliopsoas release by Dr. Aoki. Each subjects contralateral nonoperative hip will serve as~     their own control. To delineate the effects of arthroscopic surgery alone from those~     resulting from iliopsoas release in addition to arthroscopic surgery, we will recruit a~     second control group consisting of patients who have undergone arthroscopic surgery by Dr.~     Aoki without iliopsoas release.~      For both hips of each subject, we will:~        -  Quantify the muscle volume of the iliopsoas muscle with MRI.~        -  Quantify hip flexion strength with isokinetic dynamometry.~        -  Quantify patient function and satisfaction with functional outcome surveys.~      This data will allow us to test the following hypotheses:~        -  Compared to the non-operative hip, hips undergoing arthroscopic iliopsoas release have~          decreased iliopsoas muscle volume and hip flexion strength.~        -  Compared to hips undergoing arthroscopic surgery without iliopsoas release, hips~          undergoing arthroscopic iliopsoas release have decreased iliopsoas muscle volume and hip~          flexion strength.~        -  Patient function and satisfaction positively correlates to muscle bulk and strength.~   "
137816|NCT01763359|"~     The purpose of this prospective study is to compare hip adductor strength and obturator nerve~     palsy between acetabular fracture patients whose fracture was reduced and fixated using the~     modified Stoppa approach (subjects) and pelvic fracture patients (controls) using physical~     strength testing, radiographs, clinical assessment, and a validated functional outcome~     questionnaire. The investigators' research hypothesis is that there will be less strength and~     higher incidence of obturator nerve palsy in patients treated with the modified Stoppa~     approach (intervention) than in patients treated without the modified Stoppa approach~     (controls).~   "
137817|NCT01763346|"~     Weight loss achieved through gastric banding will be superior to treatment with metformin in~     preserving or restoring pancreatic beta cell function in people with prediabetes or mild type~     2 diabetes.~   "
137818|NCT01763333|"~     To investigate the safety, tolerability, pharmacokinetics and the relative bioavailability of~     BI 1026706~   "
137819|NCT01763320|"~     Patients with symptomatic stenosis of intradural arteries are at high risk for subsequent~     stroke. Since the SAMMPRIS trial, stenting is no longer recommended as primary treatment,~     however, the results of this trial, its inclusion criteria and its center selection received~     significant criticism and did not appear to reflect our experience, neither regarding natural~     history, nor treatment complications rate. As ICAS is the most common cause for stroke in~     Asian countries, we are hereby proposing a refined prospective randomized multicenter study~     in an Asian population with strictly defined patient and participating center inclusion~     criteria.~      The China Angioplasty & Stenting for Symptomatic Intracranial Severe Stenosis (CASSISS)~     trial, is an ongoing, government-funded, prospective, multicenter randomized trial. It~     recruits patients with recent TIA or stroke caused by 70-99% stenosis of a major intracranial~     artery. Patients with previous stroke related to perforator ischemia will not be included.~     Only high-volume center with a proven track record will enroll patients as determined by a~     lead-in phase. Patients will be randomized (1:1) to best medical therapy alone or medical~     therapy plus stenting. Primary endpoints are any stroke or death within 30 days after~     enrollment or after any revascularization procedure of the qualifying lesion during~     follow-up, or stroke in the territory of the symptomatic intracranial artery beyond 30 days~     The CASSISS trial will be conducted in 8 sites in China with core imaging lab review at a~     North American site and aims to have a sample size of 380 subjects (stenting, 190; medical~     therapy, 190). Recruitment is expected to be finished by Dec, 2016. Patients will be followed~     for at least three years. The trial is scheduled to complete in 2019. In the proposed trial,~     certain shortcomings of SAMMPRIS including patient and participating center selection will be~     addressed. The present manuscript outlines the rationale and design of the study. We estimate~     that this trial will allow for a critical reappraisal of the role of intracranial stenting~     for selected patients in high volume centers.~   "
137820|NCT01763307|"~     Vitamin K1 cream may prevent papulopustular rash induced by EGFRI given to metastatic~     colorectal cancer patients.~      This study will prospectively accrue metastatic colorectal patients receiving EGFRI and treat~     with reconval cream half face versus placebo cream half face to study whether Vitamin k1~     cream can prevent the typical skin eruption caused by EGFRI.~   "
137821|NCT01763294|"~     There is a continuous necessity for the search of new alternatives for safe, affordable and~     effective noninvasive therapies for patients that are not eligible for focal resective or~     palliative surgery. The transcranial direct current stimulation (tDCS) therapy has~     demonstrated to be safe, noninvasive, simple and effective with promising results in case~     series, case reports and animals models for the treatment of intractable epilepsy. tDCS is a~     feasible and low cost method to modify cortical excitability in a non-invasive procedure. Its~     effects on cortical excitability seem to be similar to the effects induced by repetitive~     transcranial magnetic stimulation. The aim of this study is determine the safety and efficacy~     in the reduction of the number of seizures (>50%) and epileptiform activity in patients with~     refractory and multifocal epilepsy after different protocols of tDCS compared with placebo.~   "
138003|NCT01760928|"~     A selection of asthma patients were followed during preparation to climb the Aconcagua~     mountain. The primary goal of this follow up was to optimize patients' asthma status. Also~     during expedition, these patients were daily consulted by a physician. All data obtained~     during preparation and expedition will now be retrospectively analyzed.~   "
137822|NCT01763281|"~     The investigators have been developing new, non-invasive magnetic resonance imaging (MRI)~     techniques to image the small bowel. Building on those studies the investigators want to~     study, in healthy volunteers, the effects of stress on the water content of the small bowel~     following ingestion of fructose. This is important because in Irritable Bowel Syndrome (IBS),~     there seems to be a strong association of stress and anxiety with the severity of the~     disease. Many IBS patients complain of food intolerances and recent studies have suggested~     that food with high content of fructose can worsen symptoms of IBS. The investigators will~     carry out a study in which the investigators will induce a moderate state of stress in~     healthy volunteers using an injection of corticotrophin release hormone, feed them a drink~     containing fructose and image their bowel at intervals using MRI. Improving our understanding~     of the effects of stress and fructose on small bowel physiology will help us to understand~     better some aspects of the symptoms such as bloating, altered bowel habit and abdominal~     discomfort, experienced by the IBS patients and to guide therapy. The investigators~     hypothesize that the effect of CRH will cause significant decrease in small bowel water~     content (SBWC) and a faster small bowel transit with increased malabsorption following~     consumption of fructose.~   "
137823|NCT01763268|"~     Open-label, single-arm trial, Primary Objectives included:~        1. To assess the immunogenicity of TrivivacTM administered in healthy infants aged between~          9-14 months.~        2. To assess the safety (reactogenicity) of TrivivacTM administered in healthy infants aged~          between 9-14 months.~      The study will be done on healthy infants, 9-14 months of age. After enrolment, the infants~     will be given one dose of primary vaccination MMR (TrivivacTM),SEVAPHARMA BiogenetechLtd.~     study vaccines will be administered subcutaneously into the anterolateral aspect of right~     thigh.outer aspect of the upper arm. Subjects will be followed at approximately 6 weeks after~     primary vaccination to evaluate response to primary immunization of this vaccine. Blood~     sample will be collected from subjects at visit 1 (prior to immunization) and visit 2 (6~     weeksone month after completion of this first dose of immunization). The serum samples will~     be analysed for Anti-measles, Anti-mumps and Anti-rubella antibodies. Proportion of subjects~     achieving seroprotection and geometric mean titers of antibody against measles, mumps,~     rubella at 6 weeks after one dose vaccination of MMR vaccine at aged 9-14 months will be~     evaluated. Adverse reactions will be observed on each vaccination day (up to 30 minutes) and~     for 4 days (Day 0-3) after each dose. Adverse reactions will also be monitored for 30 days~     following each vaccination. Serious adverse events will be monitored for the entire study~     duration.~   "
137824|NCT01763255|"~     Cerebral palsy (CP) is condition, sometimes thought of as a group of disorders that can~     involve brain and nervous system functions such as movement, learning, hearing, seeing, and~     thinking.Cerebral palsy is caused by injuries or abnormalities of the brain. Most of these~     problems occur as the baby grows in the womb, but they can happen at any time during the~     first 2 years of life, while the baby's brain is still developing.Bone marrow derived stem~     cells are known as a effective therapy.~      In this study the investigators evaluate the side effect of multiple intrathecal injection of~     bone marrow stem cell in patients with cerebral palsy.~   "
137825|NCT01763242|"~     Aims:~        1. To establish an electronic process for CKD anaemia management using monthly synchronized~          dosing of erythrocyte stimulating agents (ESA).~        2. To compare this electronic process with present anaemia management in the traditional~          outpatient setting.~        3. To monitor Hb targets and clinical endpoints of study groups to model a larger~          multicentre study focusing on these endpoints.~   "
137826|NCT01763229|"~     To test if transthoracic echocardiography is useful for correct positioning of central venous~     catheters in infants with congenital heart disease~   "
137827|NCT01763216|"~     Late-life depression levels are escalating, and include 24% of all tenants of Assisted Living~     (AL) settings. A promising, novel intervention is a computerized visual speed of processing~     training program known as Road Tour. Road Tour has been show to reduce depressive symptom~     levels and the risk of onset of clinical depression in community dwelling older adults. The~     investigators hypothesize that similar benefits will accrue to residents in AL settings.~      To evaluate this the investigators will use a two-arm, parallel, randomized controlled trial~     (RCT) comparing Road Tour training to attention control using computerized crossword puzzles~     among 370 adults 55 years old or older who reside in 15-30 AL settings that are partnering~     with the investigators.~      The investigators hypothesize that Road Tour participants will have improved cognitive~     processing speed, lower levels of depressive symptoms, lower likelihood of the onset of~     clinical depression, less anxiety, lower levels of pain symptoms, and better health-related~     quality of life. These outcomes will be assessed at baseline, post-training, six months, and~     one year.~   "
137828|NCT01763203|"~     The purpose of this study is to test a newly-developed outpatient clinic and community-based~     care intervention called SUCCEED (Secondary stroke prevention by Uniting Community and~     Chronic care model teams Early to End Disparities) for improving control of stroke risk~     factors among stroke patients in the Los Angeles County safety net, and to measure the~     costs of running such an intervention, relative to usual care.~   "
137829|NCT01763190|"~     Primary Objective:~      To study the effect of mild, moderate and severe renal impairment on the pharmacokinetics of~     SAR302503.~      Secondary Objective:~      To assess the tolerability of SAR302503 given as a single 300 mg dose in subjects with mild,~     moderate and severe renal impairment and in matched subjects with normal renal function.~   "
137830|NCT01763177|"~     Rationale: Delivery dry gas during anesthesia is associated with post-operative sore throat~     (POST). Oxygen nebulizer therapy increases humidity to the airway, especially~     post-extubation.~      Objective: To investigate the effect and complications of oxygen nebulizer therapy on POST.~   "
137886|NCT01762449|"~     The primary intent of this study is to add to the body of knowledge on scleroderma patients~     with interstitial lung disease. While lung disease is recognized as the leading cause of~     death amongst patients with scleroderma, there is not a large body of literature describing~     the long-term morbidity and mortality rate of these scleroderma patients. For this reason,~     the investigators are following participants of the Scleroderma Lung Study (NCT00004563)~     after their participation in that study was concluded. In addition, the investigators will~     assess if the subjects who received one year of oral cyclophosphamide in the Scleroderma Lung~     Study experienced progression of their scleroderma-related lung disease following the end of~     the study.~   "
137831|NCT01763164|"~     Two-arm, randomized, prospective, open-label, multi-center, phase III study to compare the~     efficacy and safety of MEK162 (45 mg BID) versus dacarbazine (1000 mg/m2 IV every 3 weeks) in~     patients with advanced (Stage IIIC) unresectable or metastatic (Stage IV) NRAS Q61~     mutation-positive cutaneous or unknown primary melanoma. The mutation analysis will be~     performed at a central laboratory. Only those patients with Q61 mutation per central~     laboratory and meet all eligibility criteria will be randomized. A total of 393 patients will~     be randomized 2:1 to receive either MEK162 or dacarbazine. Patients will be stratified~     according to AJCC stage (IIIC, IVM1a, and IVM1b versus IVM1c), ECOG Performance status (0~     versus 1) and any prior number of lines of immunotherapy (immunotherapies versus none). This~     study will use an Interactive Response Technology (IRT). The primary end point of the study~     is progression-free survival. Key secondary end point is overall survival~   "
137832|NCT01763151|"~     With increasing demands of patients concerning refractive outcome after cataract surgery,~     toric intraocular lenses (IOLs) that correct corneal astigmatism have been introduced more~     widely to cataract surgery. Originally toric IOLs were used mainly for patients with high~     degrees of astigmatism, especially after corneal surgical procedures such as penetrating~     keratoplasty. Since a couple of years, toric IOLs are available from numerous manufacturers~     to correct lower amounts of astigmatism which are much more prevalent with about 30% having a~     corneal astigmatism of 0.75D or more in the cataract population. This should result in less~     spectacle dependence of patients due to the astigmatic correction.~      The alternative method to reduce corneal astigmatism as part of cataract surgery is to make~     incisions on the steeper axis of the cornea such as limbal relaxing incisions or an~     additional clear corneal incision opposite (OCCI) to the main cataract opening. These~     techniques are in use since more than 2 decades and are widely used in clinical routine. As~     with toric IOLs, precise alignment of the cuts with the axis of astigmatism is essential. The~     disadvantage of the incisional techniques is the variability of the effect between patients~     since it depends on factors such as the extent of scaring of the cuts after surgery as well~     as corneal thickness. The main advantage is the simplicity of the technique and the lower~     cost.~      Aim of this study is to compare toric IOL implantation and opposite clear corneal incision~     during cataract surgery to correct corneal astigmatism.~   "
137833|NCT01763138|"~     The purpose of this study is to determine the effect of an educational intervention on~     mothers knowledge, attitudes and practices for preventing childhood caries.~   "
137834|NCT01763125|"~     Establishment of a tumor bank, consisting of blood samples of tumor patients and healthy~     people as controls. The blood samples will be collected systematically together with the~     corresponding clinical data. The biological samples, the clinical date together with~     prospective experimental date constitute the entity of the tumor bank.~   "
137835|NCT01763112|"~     Title of study / project: Influence of training with whole body vibration device on Quality~     of Life (QoL), exercise capacity, as well as on the effects of muscle power and muscle~     function in patients with pulmonal arterial hypertension (PAH). Background and rationale for~     the proposal:Capacity and the ability to exercise, in patients with PAH is limited. There is~     a few investigations evaluating the effects of the training with whole body vibration (wbv)~     in adults. It was shown that wbv-training could improve muscle power, QoL, body balance and~     had positive effects on the neuromuscular system. Primary scientific question~     addressed:Changes in muscle power, changes in 6-Minute Walk Distance (6MWD) and changes in~     QoL are to be evaluated.~   "
137836|NCT01763099|"~     The purpose of this study is to evaluate the utility of treating patients experiencing graft~     failure after autologous hematopoietic stem cell transplantation with ex-vivo-expanded~     BM-drived mesenchymal stem cells from third-party donors or mesenchymal stem cells combined~     with cord blood. The first objective of this study was to evaluate the effect of such~     treatment on graft failure, and second object was to investigate the safety of such~     treatment.~   "
137837|NCT01763086|"~     The purpose of this study is to evaluate the utility of treating patients experiencing poor~     graft function after allogeneic hematopoietic stem cell transplantation with ex-vivo-expanded~     BM-drived mesenchymal stem cells from third-party donors. Our first objective was to evaluate~     the effect of such treatment on poor graft function, and second object was to investigate the~     safety of such treatment.~   "
137838|NCT01763073|"~     The objective of this study is to ascertain factors shaping medical students' pre-residency~     intention to provide abortion through an in-depth qualitative investigation into the context~     and experiences that shape intention to provide.~   "
137839|NCT01763060|"~     Patients treated with Extracorporeal Membrane Oxygenation (ecmo) for severe respiratory or~     circulatory failure show severe long term disability due to impaired lung -, cerebral-,~     cognitive function and impaired quality of life. This study investigates the long term~     outcome of all patients who are still alive three years after ECMO treatment for severe~     respiratory failure during the H1N1 2009 pandemic at the Karolinska University Hospital.~   "
137840|NCT01763047|"~     The objective of this study is to evaluate the performance of a novel multifocal lens system.~   "
137841|NCT01763034|"~     Contrast media induced nephropathy (CIN) is considered to be a serious complication in~     patient who underwent coronary angiogram (CAG). The pathogenesis of CIN does not well~     understood. The probable one is the contrast media makes the afferent vessel in glomeruli~     constrict and results in renal shut down. Limb ischemic preconditioning, a procedure that~     makes muscles become ischemic and adapt themselves to produce some cytokines for signaling~     the vessel more dilated. After the reperfusion, these cytokines are getting back to systemic~     circulation and effect the afferent vessel in glomeruli to become more dilated and prevent~     CIN.~   "
137842|NCT01763021|"~     The purpose of this study is to assess the potential effects of rifampin on the~     pharmacokinetics (how the drug concentrations change over time) of PCI-32765 in healthy~     participants.~   "
137843|NCT01763008|"~     The purpose of this study is to assess the safety and effectiveness of doripenem treatment~     among Filipino patients with nosocomial pneumonia, complicated intra-abdominal infections,~     and complicated urinary tract infection.~   "
137887|NCT01762436|"~     β-blockers (BBs) with different pharmacological properties may have heterogeneous effects on~     sympathetic nervous activity (SNA) and central aortic pressure (CAP), which are independent~     cardiovascular factors for hypertension. Hence, we analyzed the effects of bisoprolol and~     atenolol on SNA and CAP in hypertensive patients.~   "
137844|NCT01762995|"~     Human immune virus (HIV) infected subjects may take mineral supplements in combination with~     their antiretroviral medications. Calcium and Iron supplementations are commonly used and~     both of these have the potential to interact with Dolutegravir (DTG), this study will~     evaluate the potential of calcium and iron supplements to decrease DTG exposure. It will also~     evaluate two possible strategies for combined use; if an interaction is observed. The first~     strategy is a two hour separation. The second strategy involves the administration of DTG and~     the supplement with a meal since the presence of food modestly increases DTG exposure, and~     because mineral supplements can be administered with food.~      This is an open label, randomized, two cohort, four-period cross-over study in healthy~     volunteers. One cohort will examine the effects of calcium carbonate and the other cohort~     will examine the effects of ferrous fumarate on the pharmacokinetic (PK) of DTG.~     Approximately 12 subjects will be enrolled into each of the two cohorts and receive each of~     four treatments in a randomized fashion: 1) A single dose of DTG 50 milligram (mg)~     administered under fasted conditions ; 2) A single dose of DTG 50 mg co-administered with a~     single dose of calcium carbonate or ferrous fumarate under fasted conditions ; 3) A single~     dose of DTG 50 mg co-administered with a single dose of calcium carbonate or ferrous fumarate~     with a moderate-fat meal; 4) A single dose of DTG 50 mg administered under fasted conditions~     2 hours prior to administration of a single dose of calcium carbonate or ferrous fumarate.~     There will be a washout period of at least 7 days between treatments. Safety evaluations and~     serial PK samples will be collected during each treatment period. A follow-up visit will~     occur 7-14 days after the last dose of study drug. This study will be conducted at one center~     in the United States, with healthy adult male and female subjects.~   "
137845|NCT01762982|"~     The aim of the study is to evaluate the irritation potential of benzalkonium chloride~     disinfectant spray when placed in contact with normal human skin.~   "
137846|NCT01762969|"~     The investigators will check the feasibility of using early molecular response for making~     treatment decisions. Patients diagnosed with chronic myeloid leukemia will commence imatinib~     treatment. After 3 months of treatment their response will be assessed. If molecular response~     would be less the 10% (BCR-ABL1/ABL ISI >10%)imatinib therapy will be stopped and patients~     will start a different TKI (as nilotinib, dasatinib). The investigators will follow on lab~     and clinical outcomes.~   "
137847|NCT01762956|"~     The pelvic floor disorders are a major problem in our current society with manifestations of~     micturition disorders, defecatory problems and sexual dysfunction. The pelvic floor muscles~     training arouses interest due the few studies on this subject. Studies are being conducted~     with emphasis on the post-prostatectomy urinary disorders, however, not associated with~     radiotherapy. The study of the effect of radiotherapy in these muscles is still uncertain. At~     right, we do not know if the effect of radiation can trigger important anatomical changes~     that could lead to pelvic floor disorders manifesting clinically as defecatory and urinary~     disorders. These issues motivate us to research, focusing on the evaluation of these muscles~     through magnetic nuclear resonance considering that radiation therapy has been increasingly~     used as a therapeutic option in the treatment of prostate cancer. The primary objective of~     this is to verify the effect of pelvic floor muscles training (PFMT) tract symptoms (LUTS),~     anorectal and sexual complaints in men with prostate cancer (PCa) treated with radiotherapy~     (RT). Secondly, the objective is to evaluate the effect of PFMT in its function and in the~     severity of urinary incontinence (UI) and evaluate the quality of life. The assessment of the~     changes occurred by the effect of radiation separately and jointly to the training of the~     pelvic floor muscles can help us to better understand some of the dysfunctions presented in~     this sample of patients as well as understanding the effect and the possible contribution of~     training of these muscles for treatment and/or prevention of these disorders.~   "
137848|NCT01762943|"~     Understanding the neural and biological mechanisms by which reproductive hormones influence~     mood is critically important for public health given that postpartum depression (PPD) is the~     leading cause of morbidity and mortality associated with childbirth and has negative effects~     on infants. Using a hormone-withdrawal challenge to precipitate mood symptoms will improve~     our ability to identify the biological mechanisms underlying both the triggering of and~     susceptibility to depressive disorders in women; and will permit the prediction of those at~     risk for PPD and other reproductive-related mood disorders.~   "
137849|NCT01762930|"~     Background:~      Cholera is a public health problem globally and in Bangladesh and its prevention is~     important. Despite recent availability of an effective and affordable oral cholera vaccine~     (OCV), its field application remains a challenge and needs to be addressed in carefully~     conducted research studies.There is lack of information on temperature sensitivity and~     resulting immunogenicity of Shanchol OCV and it is not known if administration of two doses~     of OCVs, one month apart, instead of currently recommended 14 days, to improve success of~     vaccination programme will be effective;also if one dose of the vaccine, instead of currently~     recommended two doses, would result in adequate immune response in population exposed to V.~     cholerae in an endemic country like Bangladesh.~      Objectives:~      To determine immunogenicity of Shanchol in adults. when:~        1. the vaccine is stored at three defined temperatures(25 oC ,37 oC and 42oC) for 14 days,~          before putting back in cold box for administration in the field and compare them with~          the response when the vaccine is stored under currently recommended temperatures.~        2. two doses of the vaccine administered one month apart and compared vaccines administered~          at currently recommended interval of 14 days.~        3. a single dose is administered and compare them with responses after recommended two~          doses.~      Methods: The study will be conducted among adults living in the Mirpur community in urban~     Dhaka, the capital of Bangladesh.Studying safety and acute and long-term immune responses~     over a period of one year.~      Outcome measures/variables:~        1. Objective 1: safety and immunogenicity of vaccine in adults after its storage at three~          defined temperatures (25oC ,37oC and 42oC) by measuring vibriocidal antibody responses~          and compare them with the findings when the vaccine is stored at currently recommended~          temperature of 2-8oC (recommended by manufacturer, Shantha Biotechnic).~        2. Objective 2: compare vibriocidal responses following administration of two doses of the~          vaccine one month apart and compare them with vaccination 14 days apart over a period of~          one year, with study of the memory responses over a one year period as a secondary~          outcome.~        3. Objective 3: compare acute immune responses (vibriocidal antibody) following one and two~          doses of vaccine, and compare memory response as a secondary outcome measure, over a one~          year period.~      The above information is needed urgently for developing effective vaccination strategies for~     prevention and control of cholera in endemic countries.~   "
137850|NCT01762917|"~     Non-invasive inert gas rebreathing (IGR) based on the Fick Principle showed promising results~     in the determination of pulmonary blood flow (PBF). The volume of the rebreathing bag (Vbag)~     is proposed by the system, however, elderly patients or those suffering from high grade~     pulmonary diseases might be unable to entirely rebreathe this volume and therefore fail to~     completely mix the test gases. The aim of our study is to evaluate the effect of adapting~     Vbag on the reproducibility of IGR measurements in patients with obstruction (group A),~     restriction (group B) and pulmonary healthy controls (group C).~   "
137851|NCT01762904|"~     Currently there are few options for skin antisepsis, commercially antiseptic triclosan is~     mainly used. To have more options, this study is necessary, where investigators will~     determine the residual effect of 2% chlorhexidine in 70% isopropyl alcohol and 1% triclosan~     in 70% isopropyl alcohol and choose the one with the best characteristics for skin~     antisepsis.~   "
137852|NCT01762891|"~     Coumadin drug-drug interactions (DDI) are frequent. Patients in permanent use of coumadin are~     advised to avoid traditional nonsteroidal antiinflammatory drugs to avoid risk of bleeding.~     New selctive cyclooxygesase 2 inhibitors arisen as potential option for treating pain and~     inflamation in these patients once interactions with coumadin are supposed to be lower. The~     CI(R)CA study was made to evaluate in a prospective fashion the occurrence of DDI with new~     cyclooxygenase antiinflammatory drugs and coumadin when compared to acetaminophen and~     placebo.~   "
137853|NCT01762878|"~     GSK2269557 is potent and highly selective inhaled phosphoinositides 3-kinases -delta~     (PI3K-delta) inhibitor being developed as an anti-inflammatory agent for the treatment of~     inflammatory airway diseases. GSK2269557 has already been administered as a nebulized~     solution in single and repeat doses to humans and has been well tolerated across the range of~     doses used. The purpose of this study is to evaluate the safety, tolerability and~     pharmacokinetics of single and repeat inhaled doses of GSK2269557 as a dry powder. This study~     is the first administration of dry powder GSK2269557 in humans.~      Part A will consist of four treatment periods separated by at least 14 days wash out periods.~     In each treatment period there will be 12 subjects receiving GSK2269557 and 4 subjects~     receiving placebo. The doses of GSK2269557 planned for Part A are 100 micrograms (mcg), 500~     mcg and 3000 mcg. Blinded safety and available pharmacokinetic (PK) data will be reviewed~     before each dose escalation. Part B will be a parallel group design conducted in a separate~     group of subjects from Part A. Nine subjects will receive repeat doses of GSK2269557 and 3~     subjects will receive repeat doses of placebo for 14 days. The total daily dose will be the~     same as the dose that was well tolerated in Part A. The study duration, including screening~     and follow-up, is not expected to exceed 82 days for subjects in part A and 55 days for~     subjects in part B of the study.~   "
137854|NCT01762865|"~     The investigators hypothesized that acute bronchitis will be associated with various bacteria~     and viruses.~   "
137855|NCT01762852|"~     The main clinical study will be a randomized, double-blind, placebo-controlled, long term~     study involving a 100 week treatment period. The purpose of this study is to test for~     superiority of treatment with belimumab 10 mg/kg plus supportive therapy compared to placebo~     plus supportive therapy in idiopathic membranous nephropathy (IMN). The purpose of this study~     is also to investigate the effect of initiating earlier treatment with belimumab compared to~     delayed treatment with current immunosuppressive treatment regimens. The study will also~     determine the pharmacokinetic (PK) profile of belimumab and further explore the mechanism of~     action of Belimumab as well as effects on quality of life. All subjects (on either active~     treatment or placebo) will receive background supportive therapy throughout the main clinical~     study, which includes angiotensin-converting enzyme inhibitors (ACEi) and/or angiotensin~     receptor blockers (ARBs) unless contraindicated and may include statins, diuretics, dietary~     salt restriction but excludes immunosuppressants (except low dose corticosteroids). Screening~     will be done within 5 to 2 weeks before the first scheduled dose of study treatment. A total~     of 94 evaluable subjects will be randomized in a 1:1 ratio such that 47 subjects receive~     intravenous belimumab 10 mg/kg and 47 receive intravenous placebo. Subjects will be dosed on~     Days 0, 14, 28 and then every 4 weeks through to, and including, Week 100, resulting in a~     total of 27 doses (giving 104 weeks of drug exposure). The dosing frequency will be adjusted~     to every 2 weeks if the subject's proteinuria as assessed by urinary protein creatinine ratio~     (PCR) is greater than 1000mg/mmol (greater than 10 g/24 h), to compensate for loss of~     belimumab in the urine. Subjects who are withdrawn from study treatment at any time during~     the study, eg for rescue therapy, will participate in follow-up visits every 12 weeks up to~     week 104. A subject will be regarded as having completed the main clinical study if they~     complete all phases of the main clinical study (screening, treatment period, 4 week and 16~     week post last dose short term safety follow-up). Subjects who complete the main clinical~     study will therefore participate in the main clinical study for approximately 28 months.~     After the main clinical study, there will be a 5 year (long term) follow-up phase to assess~     long term outcomes.~   "
137856|NCT01762839|"~     The purpose of the study is to generate cardiac safety data using a supratherapeutic~     oritavancin dose of 1600 mg.~   "
137857|NCT01762826|"~     Comparison of different inositol stereoisomears in preventing adverse obstetric outcomes in~     non-obese pregnant women at high risk for gestational diabetes mellitus.~   "
137858|NCT01762813|"~     -  A prospective, observational study on clinical outcomes of surgical management of~          primary and metastatic colorectal cancer~        -  Prospective collection of tissues to explore potential biomarkers in blood and/or~          primary or secondary cancers and/or normal colon~   "
137859|NCT01762800|"~     The purpose of this study is to assess the control of COPD using a symptom and exacerbation~     risk based treatment strategy based on GOLD 2011. This study is conducted in Japanese~     subjects with COPD and assess whether the GOLD 2011 strategy is effective in medical practice~     in Japan.~   "
137860|NCT01762787|"~     The purpose of this study is to refine the cantharidin-induced blister assay in healthy~     volunteers as a model of inflammatory disease. The study is an experimental trial in healthy~     volunteers in two parts; Part 1 to optimise the model and Part 2 to validate using two~     anti-inflammatory treatments with different modes of action.~   "
137861|NCT01762774|"~     This study is the First Time in Human Study for GSK2256294 and will evaluate the safety,~     tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and repeat oral doses~     of GSK2256294 administered to healthy male volunteers (Cohort 1) and otherwise healthy adult~     male moderately obese smokers (Cohorts 2 to 4). Cohorts 1 and 2 will enrol 12 subjects each~     and each subject will take part in four study periods. All subjects will receive placebo~     regimen and three dosing regimens of GSK2256294 in a specified sequence (planned doses 2 mg,~     6 mg and 18 mg in Cohort 1 and 15 mg, 40 mg and 100 mg in Cohort 2). Each study period will~     be followed by a Wash-out period of 7 to 14 days in Cohort 1 and up to 4 weeks in Cohort 2.~     During each study period subjects will be in-house from Day -1 until the 48 hours post dose~     assessments have been completed. Subjects will return to the unit as out-patients for~     remaining post-dose assessments. Subjects will then be followed for 7 to 14 days in Cohort 1~     and up to 3 to 4 weeks in Cohort 2. Total duration of the study for Cohort 1 will be 98 days~     and for Cohort 2 it will be up to 144 days. Cohort 3 and 4 will each recruit 15 subjects. For~     Cohorts 3 and 4, each subject will take part in one treatment period of 18 days (Day-1 to Day~     17) with dosing from Day 1 to Day 14. Subjects will then be followed for 7 to 14 days. Total~     duration of the study for Cohort 3 and Cohort 4 will be 67 days. Dose selection for Cohorts 3~     and 4 will be based on the safety, PK profile and enzyme inhibition obtained in Cohorts 1 and~     2. This study will also evaluate the evidence for a functional effect of soluble Epoxide~     Hydrolase (sEH) in a forearm blood flow (FBF) model.~   "
137897|NCT01762306|"~     Abnormal uterine bleeding is common in Thai women. Traditionally, because of a larger number~     of patients, the diagnosis of its cause is performed via fractional curettage under local~     anesthesia such as paracervical nerve block or intravenous meperidine.~      Pain is one of a common adverse effect of this procedure and this topic should be concerned~     by a responsible doctor.~      NSAIDs, Diclofenac Potassium in this study, is known as a drug which is effective for pain~     control and is as effective as coxib in acute pain management. Because of its cost, easy~     accessible and easy administration, Diclofenac Potassium was selected to be used in this~     study. Its onset of action is about 1 hour and only one dose of this drug do not cause any~     serious side effects.~      The hypothesis of this study is that Diclofenac Potassium has an additional effectiveness~     for acute pain control in patients undergoing fractional curettage under paracervical nerve~     block due to abnormal uterine bleeding Double blind randomised controlled trial was~     performed in this study with 45 patients included in each group.~   "
137862|NCT01762761|"~     This randomized, double-blind and open-label phase III study is aimed to determine the~     efficacy, tolerance and safety of eltrombopag in Chinese chronic primary immune~     thrombocytopenia (ITP) adult subjects. This study will be conducted in Chinese adult chronic~     ITP subjects who have not responded to or have relapsed after previous treatment for ITP,~     including first line therapy and /or splenectomy.~      The primary objective of this study is to determine the efficacy of oral eltrombopag as a~     thrombopoietic agent treating previously treated chronic Chinese ITP patients comparing with~     placebo. The secondary objective is to assess the safety and tolerability of eltrombopag when~     administered for 6 weeks to previously treated adult chronic ITP patients comparing with the~     placebo. In addition, the long-term efficacy and safety of eltrombopag treatment will be also~     evaluated in the 24-week extension open-label phase after the double-blind phase as one of~     other study objectives. If the subject benefits from the eltrombopag treatment based on~     investigator's discretion, the subject can continue eltrombopag treatment until the~     commercial launch of eltrombopag in China. Furthermore, to understand the pharmacokinetics~     (PK) profile of eltrombopag and to explore the relationship between the PK and~     pharmacodynamics (PD) (platelet response), a PK/PD analysis will be embedded in this phase~     III study and conducted in the same patient population participated this phase III study.~   "
137863|NCT01762748|"~     The purpose of this study is to evaluate the effect of Saccharomyces boulardii in patients in~     the waiting list for liver transplant.~   "
137864|NCT01762735|"~     Water injection colonoscopy has been a generally accepted method in training the beginners of~     colonoscopy for its low pain and less cecal intubation time, we would conduct this study to~     investigate more advantages of this method and make most use of it for beginners' training.~   "
137865|NCT01762722|"~     A cerebral oximeter is a device that uses light to measure the amount of oxygen within the~     brain. It is similar to the device that measures the level of oxygen in the tip of the~     finger, known as a pulse oximeter. The cerebral oximeter consists of a sensor placed on the~     forehead that both emits and detects the amount of light absorbed. This study will determine~     how accurate the device is by comparing the displayed value on the monitor with blood samples~     taken simultaneously from the arterial blood in the wrist and venous blood in the neck. In~     order to test the device over a suitable range, the level of oxygen within the blood will be~     reduced in a controlled manner by reduction of the inspired oxygen concentration. This is the~     equivalent of ascending to an altitude of 16,000 feet. The study will be conducted in healthy~     volunteers.~   "
137866|NCT01762709|"~     The use of low tidal volume (TV) during one lung ventilation (OLV) for thoracic surgery~     decreases the incidence of postoperative acute lung injury (ALI). We postulated that the use~     of low TV during OLV for video-assisted thoracoscopic surgery (VATS) would decrease the~     extravascular lung water content index (EVLWI). After local ethics committee approval and~     informed consent, we will randomly allocate 60 patients scheduled for elective VATS to~     ventilate the dependent lung with VT of 4, 6, or 8 mL/kg (n= 20 for each), I: E ratio 1: 2.5,~     PEEP of 5 cm H2O, recruitment maneuvers and respiratory rate will be adjusted to maintain~     normocapnia. Perioperative changes in EVLWI, hemodynamics, oxygenation index will be~     recorded. Also, the incidence of postoperative ALI, morbidity, hospitalization and mortality~     will be recorded~   "
137867|NCT01762696|"~     The purpose of this study is to further develop and test the Momentary Self-Monitoring and~     Feedback + Motivational Enhancement Therapy (MOMENT) intervention, a real-time, contextual~     intervention to reduce marijuana use among primary care patients.~   "
137868|NCT01762683|"~     The purpose of this study is to improve the understanding of cellular mecanism involved in~     delivery disorders in obese women, first by characterizing the hyperplasia phenomenon of~     myometrail cells induced by inflammatory stimulation (Il-1B), then by studying the role of~     blood mononuclear cells, of leptine and of obese women sera to interfere with the transition~     of myometrial cells toward hyperplasia phenotype.~   "
137869|NCT01762670|"~     GoldenCare is a copper intravaginal device that may be useful for the treatment of~     symptomatic bacterial Vaginosis (BV). Standard treatment for BV is metronidazole. Although~     the reported cure rate is as high as 90%, the recurrence rate is 58% after 12 months. The~     study hypothesis is that GoldenCare will cure BV. This is a proof of concept study to collect~     preliminary evidence of the safety and efficacy of GoldenCare.~   "
137870|NCT01762657|"~     The purpose of this study is to determine if oral Cyclosporine A and oral Lansoprazole are~     effective in rendering patients with existing type 1 diabetes, insulin independent. This~     two-arm study was designed to evaluate the safety and efficacy for insulin independence by~     utilizing the FDA-approved oral immune tolerance agent, Cyclosporine A, and the FDA-approved~     proton-pump inhibitor, Lansoprazole. Lansoprazole and other proton-pump inhibitors increase~     gastrin levels. Gastrin was initially shown to have the potential to increase new beta cell~     formation in 1955 (Zollinger RM and Ellison EH. Ann Surg. 1955;142(4):709-23).~      Studies with the immune tolerance agent, Cyclosporine A, previously demonstrated that among~     recently diagnosed type 1 diabetes patients, insulin independence was achieved in as many as~     67.5% of patients within 7 weeks of therapy (Bougneres PF et al. N Engl J Med.~     1988:17;318(11):663-70). Cyclosporine A protected the remaining beta cells from further~     autoimmune attack, but over time, there was limited beta cell regeneration, and insulin was~     ultimately required by all patients. Therefore, this study proposes the usage of Cyclosporine~     A with a beta regeneration agent.~      Follow-up studies for up to 13 years among 285 type 1 patients utilizing Cyclosporine A for~     20 months, did not demonstrate renal or other side effects (Assan R. et al. Diabetes Metab~     Res Rev. 2002;18(6):464-72). Human clinical trials with gastrin and epidermal growth factor~     demonstrated reductions in daily insulin requirements by much as 75% within 3 months~     following four weeks of therapy among existing type 1 diabetes patients (Transition~     Therapeutics, March 5, 2007 http://www.transitiontherapeutics.com/media/archive.php Accessed~     January 1, 2013). Lack of the ability to sustain these results was likely due to the ongoing~     autoimmune attack on the new beta cells generated by therapy. Gastrin alone has been shown to~     induce beta cell neogenesis from human pancreatic ductal tissue without epidermal growth~     factor in in vitro studies (Suarez-Pinzon WL et al. JCEM. 2005;90(6):3401-3409).~      Type 1 diabetes is an autoimmune disease. Despite evidence that many different immune~     tolerance agents have successfully reversed diabetes in rodent type 1 models, none have been~     successful in sustaining insulin independence in man (Ablamunits V et al. Ann NY Acad Sci.~     2007;1103:19-32). The distinctions and complexities of islets in man are far different than~     that of rodents (Levetan CS and Pierce SM. Endocr Pract. 2012 Nov 27:1-36 Epub ahead of~     print). We hypothesize that in man, both an immune tolerance agent and a beta regeneration~     agent are required to sustain insulin independence.~      Based upon proton-pump inhibitors having been shown to increase plasma gastrin levels up to~     10-fold, this clinical trial utilizes the oral proton-pump inhibitor, Lansoprazole. This~     study will determine the safety and efficacy of Cyclosporine A used with and without~     Lansoprazole to determine the impact on insulin independence among patients with existing~     type 1 diabetes.~      Cyclosporine A is utilized to protect the new beta cells formed by Lansoprazole. The~     combination of the two therapies may render reductions in insulin requirements and have a~     greater impact on sustained insulin independence than previously reported with Cyclosporine A~     or gastrin alone among type 1 patients.A~      This 52-week study consists of two treatment arms designed to assess the safety and efficacy~     of achieving insulin independence using:~        -  Oral Lansoprazole/Oral Cyclosporine A~        -  Oral Placebo/Oral Placebo~      It is hypothesized that the combination of oral Cyclosporine A and oral Lansoprazole will~     safely render significantly more patients with existing type 1 diabetes, insulin independent~     and may serve as a novel and innovative treatment approach for patients with type 1 diabetes~     utilizing two FDA-approved therapies.~   "
137871|NCT01762644|"~     The purpose of this study is to determine if the combination of oral cyclosporine, an immune~     therapy and oral omeprazole, a proton pump inhibitor, are effective in rendering insulin~     independence among recent onset type 1 diabetes patients. This two-arm study is designed to~     evaluate the safety and efficacy for insulin independence of two FDA and EMA-approved~     therapies among recent onset type 1 diabetes patients.~      One of the greatest new insights of today in the field of type 1 diabetes, is the~     understanding that in man, unlike the success seen in type 1 diabetes mouse models, there is~     no beta cell regeneration with immune therapy alone. In man, type 1 diabetes is now~     considered to be a disease of both autoimmunity and lack of beta cell regeneration (Levetan~     2103).~      More than 500 patients with new onset type 1 diabetes have been given cyclosporine and some~     studies have demonstrated as high as a 57% insulin-free remission rate that was not sustained~     due to the lack of beta cell regeneration (Feutren 1986, Bougneres 1988, Eisenbarth 1989,~     Sobel 2010). Studies among diabetes patients with proton pump inhibitors have shown the~     potential to increase beta cell mass by 40%, but among type 1 patients without immune~     protection, such outcomes cannot be not achieved (Singh 2012, Griffin 2014).~      The usage of a beta cell regeneration agent such as omeprazole, in combination with an immune~     tolerance, like cyclosporine, provides both the potential ability to maintain and regenerate~     beta cells. This is a new paradigm for the treatment of new onset type 1 diabetes.~      More than 60 human trials have been conducted among type 1 diabetes with a variety of~     different therapies aimed at preventing autoimmune attack on insulin-producing beta cells.~     None have been as effective as cyclosporine in both slowing the decline in beta cell mass and~     resulting in the potential for insulin-free remissions. (Canadian-European Randomized Control~     Trial 1988, Eisenbarth 1989, Skyler 1992, Sobel 2010).~      Because cyclosporine is known for its potential side-effects, most notably in the kidney, all~     previous studies among type 1 patients have carefully monitored kidney function. Follow-up~     studies for up to 13 years among 285 type 1 patients utilizing cyclosporine for 20 months did~     not demonstrate renal or other side effects at the dosages that will be used in this trial~     (Assan 2002).~      The most effective initiating dosage for insulin independence in the cyclosporine trials was~     7.5 mg/kg/day, but for safety, this study will begin at a lower dosage of 5 mg/kg/day and~     will monitor kidney function and cyclosporine levels initially on a weekly basis. This study~     will use only those dosages of cyclosporine that have not demonstrated toxicity to the kidney~     or resulted in non-reversible side effects among more than 500 patients with recent onset~     type 1 diabetes treated with cyclosporine.~      Omeprazole has been shown to significantly increase gastrin levels which is associated with~     increased beta cells. Lansoprazole has also been shown to be safe among patients with new~     onset type 1 diabetes for one year with a trend toward increased beta cell mass among~     patients with higher gastrin levels.~      In a randomized trial for 12 weeks among 56 patients undergoing pancreatectomy, those~     randomized to receive a proton pump inhibitor had significantly increased gastrin levels,~     higher insulin levels and improved endocrine function by glucose tolerance testing and less~     pancreatic atrophy as measured by CT scans (Jang 2003).~      The recently completed REPAIR T1D trial among newly diagnosed type 1 patients used a proton~     pump inhibitor and GLP-1 therapies for 1 year for beta regeneration failed to meet its~     endpoint of increased stimulated C-peptide. Lack of maintenance or regeneration of beta cells~     was specifically noted to have likely been due to lack of usage of immune therapy to protect~     beta cells (Griffin 2014, Rigby 2014).~      Those patients in REPAIR T1D, who did achieve gastrin and GLP-1 levels above those in the~     control group had a trend towards improved preservation of C-peptide with a suggestion of a~     decreased rate of fall of C-peptide through 12 months (Griffin 2014 Appendix Supplemental~     data). Glucose levels also trended lower than controls in the intervention arm with gastrin~     levels above the control arm (Griffin 2014 Appendix Supplemental data). In humans, the newly~     forming beta cells are under the greatest immune attack among type 1 patients (Meier 2006).~     REPAIR T1D underscores the importance for both immune therapy with a regeneration therapy~     among type 1 patients (Griffin 2014, Rigby 2014).~      The combination of cyclosporine with a proton pump inhibitor has the potential to demonstrate~     maintenance and expansion of residual beta cells. This combination therapy provides the~     unique ability for patients to become insulin independent.~      For a request of references, please email info@perlebioscience.com~   "
137872|NCT01762631|"~     The purpose of this study is to determine if digital photography on a Smartphone and the~     Remote Food Photography Method (RFPM) can estimate infant formula intake. This is a~     validation study; there is no hypothesis.~   "
137873|NCT01762618|"~     A randomized controlled trial designed to test the effectiveness of a psychological~     intervention based on group therapy for the caregivers of Alzheimer's disease patients. The~     intervention consists of 14 sessions of a cognitive-behavioral psychological group therapy.~     This study aims to demonstrate that Alzheimer's patients' caregivers can benefit from group~     counseling, with an improvement in mood state, quality of life, perceived burden and a~     decrease in anxiety and depression. Two evaluations will be done: before the therapy sessions~     (basal) and when intervention is finished (final).~   "
137874|NCT01762605|"~     This study determines if patients with buckle fractures of the distal radius and/or ulna~     treated with supportive care only demonstrate non-inferior outcomes in regard to pain control~     during healing, functional outcome at the wrist joint, and parental satisfaction, when~     compared with patients treated with the standard treatment regimen of 3-4 weeks in a short~     arm cast.~   "
137875|NCT01762592|"~     Study WX-20-002 will confirm diagnostic efficacy and safety of a PET/CT scan using Iodine~     (124I) Girentuximab performed during the diagnostic work-up in patients with indeterminate~     cT1-renal masses.~   "
137898|NCT01762293|"~     Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and~     Flt3, and it's anti-angiogenesis effect has been viewed in preclinical tests. Phase I study~     has shown that the toxicity is manageable.~      The purpose of this study is to determine whether Famitinib can improve progression free~     survival compared with placebo in patients with advanced colorectal cancer who failed in~     previous at least two lines of chemotherapy.~   "
137899|NCT01762280|"~     Famitinib is a novel oral multitargeted tyrosine kinase inhibitor with antitumor and~     antiangiogenic activities. This study is designed to evaluate the safety and tolerability of~     Famitinib in patients with solid tumor~   "
137876|NCT01762579|"~     The aim of the investigators' study is to evaluate biochemical, immunological and~     histological characteristics of patients affected with the so-called gluten (or wheat)~     sensitivity who suffers from irritable bowel syndrome (IBS)-like symptoms.~      As it is not known what component of the cereals causes the symptoms in so called~     gluten-sensitive patients, the investigators prefer to speak of not-celiac wheat~     sensitivity (NCWS).~      NCWS patients may be defined as ones, neither celiac or allergic to wheat, who develop~     symptoms following wheat consumption, that improved on wheat/gluten free diet (GFD). For our~     research, we will select adult patients, both genders, affected with suspected NCWS (i.e.~     with symptoms/signs which disappeared on GFD and worsen on a gluten containing diet, testing~     negative for celiac disease [anti-tissue transglutaminase antibodies, anti-tTG, and~     anti-endomysium antibodies, EMA, and with biopsy Marsh 0-1] and wheat allergy [serum specific~     IgE for wheat]). The patients will be recruited at the Department of Internal Medicine,~     'Giovanni Paolo II' Hospital of Sciacca (Agrigento), and of Internal Medicine of the~     University of Palermo, from January 2012 to October 2013, for IBS-like symptoms.~      At the time of the recruitment, the patients will be on GFD by at least one month and must be~     asymptomatic. A more restricted elimination diet (with the exclusion of cow's milk, egg and~     other foods) could be prescribed in patients who are suspected to suffer from multiple food~     hypersensitivity. The patients will be randomized to undergo a double-blind~     placebo-controlled study, assuming wheat flour or placebo, administered daily for 15 days.~     Before and after the challenge, the investigators will evaluate gastrointestinal~     (Gastrointestinal Symptom Rating Scale, GSRS) and the investigators will collect blood~     sampling and biopsies from endoscopic evaluation (both esophagogastroduodenoscopy and~     rectoscopy, with multiple biopsies), for the identification of possible markers (serological,~     biochemical, immunological, histological features, expression of cytokines and other~     constitutive mucosal proteins from peripheral blood mononuclear cells and mucosal~     lymphocytes) that may be of help to diagnose the condition of NCWS and to understand its~     pathogenesis.~   "
137877|NCT01762566|"~     Aim of the investigators' study is to evaluate one of the symptoms described by patients~     affected with the so-called not-celiac wheat sensitivity (NCWS). NCWS patients may be~     defined as ones, neither celiac or allergic to wheat, who develop symptoms following wheat~     consumption and improve on Gluten Free Diet (GFD). Among these, patients often report the~     appearance of bloating and abdominal pain, and, sometimes, swelling of fingers and face,~     shortly after ingestion of wheat. They also refer that swelling tends to last for some hours~     and then to disappear on GFD. To our knowledge, this disorder has never been investigated~     neither proved.~      For the investigators' research, the investigators selected adult patients, both genders,~     affected with NCWS. Diagnostic criteria include: 1) symptoms disappearance on GFD, 2) testing~     negative for celiac disease [anti-tTG and EMA, and with biopsy Marsh 0-1] and wheat allergy~     [serum specific IgE for wheat], 3) positive response to a double-blind placebo-controlled~     challenge (DBPC) with wheat or placebo.~      Patients will be recruited among subjects referring, as outpatients, to the Department of~     Internal Medicine, 'Giovanni Paolo II' Hospital of Sciacca (Agrigento), and of Internal~     Medicine of the University of Palermo, from January 2012 to October 2013. The investigators~     will include patients referring for functional dyspepsia and/or irritable bowel syndrome~     (IBS)-like symptoms. All recruited patients must report body's swelling immediately after~     wheat ingestion. In all recruited patients, NCWS diagnosis was posed during the previous~     years, according to the above mentioned criteria.~      Patients, all on GFD for at least 30 days, will undergo to another DBPC with wheat or placebo~     (xylose), performed by administering capsules coded as A or B containing wheat or xylose,~     respectively. Capsules A or B will be administered once, and then, after 1 week of washout,~     patients received the other capsules, given once too. Before and 2 hours after every~     challenge, patients will undergo a complete medical examination (measurement of body weight,~     height, body mass index [BMI], waist circumference, diameter of thighs, legs, arms, and~     fingers), and we will perform bioelectrical impedance analysis and collect blood sampling,~     for identification of possible markers (bioelectrical, immunologic, hormonal, etc) that may~     help to demonstrate and explain mechanisms of examined symptom.~   "
137878|NCT01762553|"~     The impact of HIV/AIDS is negatively influencing the affected families and their next~     generation. HIV is radiating through the extended families, shifting the life patterns not~     only for the parents living with HIV/AIDS (PLH), but also for their children, partners, and~     other family members. To help PLHs and their family members, the TEA intervention has been~     developed, refined and piloted in the previous study. The goal of this study is to implement~     the TEA intervention in a full scale to determine its efficacy and the potential for~     enhancing HIV policy and programs that support HIV-affected families to cope with the~     challenges in China in responding to the global HIV epidemic.~   "
137879|NCT01762540|"~     The main purpose of the trial is to advance our knowledge on the possible mechanism~     underlying the catabolic effects of long-term treatment with glucocorticoid.~   "
137880|NCT01762527|"~     This protocol describes a Phase 2 clinical trial of online adaptive Radiotherapy, using a~     library of 3 dose plans corresponding to Small, Medium and Large size bladder. The procedure~     includes 'Common Toxicity Criteria for Adverse Effects'(CTCAE) for registration of adverse~     effects (baseline, every 2'nd week during RT, 2 weeks, 3, 6, 12 and 24 month after RT) as~     well as cineMR for intra-fractional motion (baseline and every week during RT). Patients~     receive standard non-adaptive RT in the first week. Delineations of the bladder on the~     Cone-Beam scans (CBCT) from first week of treatment are used for planning the Small and~     Medium size bladder plans. Large size plan are the standard non-adaptive treatment plan used~     for the first week of treatment. A margin of 5 mm for intra fractional movement is used.~   "
137881|NCT01762514|"~     RATIONALE~        -  Radiotherapy is the primary therapeutic strategy for nasopharyngeal carcinoma.~        -  Radiotherapy may cause adverse effect such as xerostomia and mucositis.~        -  Amifostine has the ability of protecting the normal tissue but also has some side~          effects.~      PURPOSE~        -  This phase II trial is to study the protecting effect and safety of different Amifostine~          regimens in patients with nasopharyngeal carcinoma.~   "
137882|NCT01762501|"~     To determine the efficacy of Azilsartan 20 mg versus Amlodipine 5 mg oral administration once~     per day for 8 weeks in patients with grade I or grade II essential hypertension.~   "
137883|NCT01762488|"~     The purpose of this double-blind, randomized and sham controlled study is to investigate the~     blood pressure lowering effect of renal denervation by catheter based ablation in the renal~     arteries in patients with milder forms of treatment resistant hypertension. The effect on~     blood pressure will be evaluated by 24-hour ambulatory blood pressure measurements at~     baseline and after 3 and 6 months of follow up. Secondary endpoint evaluation comprises~     hemodynamic assessment by applanation tonometry and the cold pressor response.~   "
137884|NCT01762475|"~     The purpose of this study is to determine whether sildenafil (Viagra®) is effective in~     improving cerebral blood flow and cerebrovascular reactivity inpatients who have persistent~     symptoms at least 6 months after a traumatic brain injury (TBI).~   "
137885|NCT01762462|"~     Primary Objective:~      To study the effect of mild and moderate hepatic impairment on the pharmacokinetics of~     SAR302503.~      Secondary Objective:~      To assess the tolerability of SAR302503 given as a single dose up to 300 mg in subjects with~     mild and moderate and hepatic impairment and in matched subjects with normal hepatic~     function.~   "
137900|NCT01762267|"~     To determine the effects of the Dietary Approaches to Stop Hypertension (DASH) diet on the~     metabolic side effects of corticosteroids medications use.~   "
137888|NCT01762423|"~     Body contouring surgery has a higher potential for postoperative pain and wound healing~     complications. The purpose of this study is to determine if pulsed electromagnetic field~     (PEMF) devices can reduce the pain and complications associated with this type of surgery.~      Pulsed electromagnetic field (PEMF) devices have been shown to be effective treatments to~     decrease healing time in nonunion fractures and pressure ulcers, and to reduce pain in~     whiplash injuries, persistent neck pain, and chronic lower back pain. These devices have been~     FDA approved for treatment of pain and edema (510(k) number: K070541). More recently, PEMF~     devices have been shown to decrease postoperative pain and narcotic use in breast~     augmentation patients. This study seeks to determine if PEMF will also cause similar effects~     in the more complex procedures performed on body contouring patients. The specific aims of~     this study are:~        1. Evaluate if adjunct PEMF therapy will accelerate the rate of postoperative pain~          reduction in abdominal body contouring patients.~        2. Evaluate if adjunct PEMF therapy will decrease the postoperative use of narcotic pain~          relievers in abdominal body contouring patients.~      PEMF devices have been shown to be effective in reduction of pain and pain medication use in~     breast augmentation patients. No literature has shown if PEMF is an effective adjunct to~     decrease pain or pain medication use in the abdominal body contouring patient. A decrease in~     pain would result in a better experience for patients and a reduction in pain medication may~     decrease complications associated with these medications. The PEMF therapy device being used~     in this study is a non-significant risk device because it is noninvasive and does not present~     a potential for serious risk to the health, safety, or welfare of a subject.~   "
137889|NCT01762410|"~     Clinical study of oral PI3K/mTOR inhibitor P7170 in patients with advanced refractory solid~     tumors. The primary objective is to determine the maximum tolerated dose and dose limiting~     toxicity of oral PI3K/mTOR inhibitor P7170 in patients with advanced refractory solid tumors~   "
137890|NCT01762397|"~     The Purpose of a randomized, double-blind, placebo-controlled, single-dose, dose-escalation~     clinical trial is to explore investigate the safety, tolerability, pharmacokinetics, and food~     effect of PMK-S005 after oral administration in healthy male volunteers.~   "
137891|NCT01762384|"~     Pelvic Organ prolapse (a feeling of bulge in the vagina) may cause some distressing symptoms~     such as loss of control of the bowel or bladder, and may also cause problems with patient's~     sex life. The primary treatment is surgery. Sacral Colpopexy is the gold standard procedure.~     Now it could be done laparoscopically. Modified total pelvic floor reconstructive surgery~     with mesh is developed in China for Asian Women.~      This study is designed to determine the effectiveness and safety of Modified total pelvic~     floor reconstructive surgery with mesh compared with laparoscopic Sacral Colpopexy for the~     treatment of uterine or vault prolapse Stage III-IV.~      Patients enrolled into the study will be followed up for up to 3 years after surgery.~     Evaluation will take place during surgery and postoperative visit. Stage of prolapse before~     and after surgery, patient satisfaction through quality of life and sexual function~     questionnaires before and after surgery, and peri-operative complication rates will be~     evaluated.~   "
137892|NCT01762371|"~     The primary hypothesis is that Khalifa's therapy has different acute effects in various organ~     systems i.e. proprioceptive, neuro-muscular, endogenous dopamine system, etc. These effects~     might indicate the pathway of the therapy.~   "
137893|NCT01762358|"~     The primary hypothesis is that Khalifa's therapy brings additional benefit compared to~     standard therapy (physiotherapy) for patients with a ruptured anterior cruciate ligament~     (ACL).~   "
137894|NCT01762345|"~     This pilot study will evaluate the efficacy of the pessary (disposable intra-vaginal device)~     by reduction in urine leakage in women with stress urinary incontinence (SUI).~   "
137895|NCT01762332|"~     In our previous study, NCT01631695, we proposed and clinically evaluated the Medasense pain~     response index, PRI, in anesthetized patients undergoing surgery. Note: the name PRI has been~     changed to NoL (Nociception Level) Index.~      The PRI is based on a non-linear combination of several pain-related physiological parameters~     into a one unique index (0-100).~      In this study we aim to validate the performance of the PRI by:~        1. investigating the patient's PRI response to surgical painful stimuli under different~          levels of analgesia:~             -  Investigating patient's PRI response to surgical painful stimuli under two~               different levels of Remifentanil Target Control Infusion (TCI) rates.~             -  Investigating patient's PRI response to standardized painful stimulus (Tetanic~               stimulus) with and without opioids.~        2. investigating the effect of beta-blockers on PRI performance in patients taking chronic~          beta-blocker treatment.~      The study is based on recording and analyzing the subject's physiological signals, while~     recording painful events, medication dosing and different clinical signs.~   "
137896|NCT01762319|"~     Abnormal uterine bleeding is common in Thai women. Fractional curettage is an diagnostic~     procedure of this condition. Traditionally, fractional curettage is performed under local~     anesthesia such as paracervical nerve block or intravenous meperidine.~      Cervical dilatation using metal cervical dilator is a common method prior to perform~     fractional curettage. However, complication from this procedure can be occurred frequently,~     for example, uterine perforation, false tract formation and laceration of cervix.~      Misoprostol is a prostaglandin E1 analogue which is commonly used in obstetrics and~     gynecology. Misoprostol transforms cervical component causing cervical ripening. This is very~     helpful for transcervical procedure because cervical dilatation is usually omitted. It can be~     prescribed in many route and sublingual route is the most effectiveness. Moreover, WHO~     supports the use of misoprostol in obstetrics and gynecology practice.~      The hypothesis of this study is that Misoprostol 200 micrograms sublingually is effective~     for cervical ripening before performing fractional curettage in patients with abnormal~     uterine bleeding Double blind randomised controlled trial was performed using 26 patients in~     each group.~   "
137901|NCT01762254|"~     To compare the two surgical options in their short-term and long term outcomes in the~     management of early left-sided colorectal cancers. The hypothesis is that the incisionless~     approach will result in less postoperative pain and wound related complications.~   "
137902|NCT01762241|"~     The purpose of this study is to investigate the effect of 12 weeks systematically training~     using the Xbox Kinect system.~      Outcome measures are made on physical function, quality of life, fatigue and metabolic~     parameters.~   "
137903|NCT01762228|"~     This study will evaluate with videofluoroscopy (radiologic method to study the deglutitive~     physiology) the effect on the deglutition of two therapeutic treatments with the duration of~     2 weeks, based on the increase of the sensorial stimuli in older patients with oropharyngeal~     dysphagia:~        1. Stimulation of Transient Receptor Potential Vanilloid 1 (TRPV1) oropharynx chanels using~          a natural agonist administrated in the alimentary bolus.~        2. Stimulation of the sensorial neurons of the pharynx and larynx using transcutaneous~          electrical stimuli.~      Moreover, with an electroencephalographic study we will assess the effect of both treatments~     in the cortical neuroplasticity.~   "
137904|NCT01762215|"~     This study examines the use of an online social media platform (PatientsLikeMe) to assist~     Veterans with epilepsy. The hypothesis is that the online social media platform,~     PatientsLikeMe, will improve selected patient-reported outcomes on perceived self-management~     skills for patients who engage in the website functions.~   "
137905|NCT01762202|"~     Assessment of safety and efficacy of with fludarabine and cyclophosphamide (FC) combined with~     ofatumumab (FCO2) in previously untreated young patients with Chronic Lymphocytic Leukemia~     (CLL).~   "
137906|NCT01762189|"~     Thirteen hospitals in China will participate in the study, which aims to provide data on~     serum bilirubin levels in the first 168 hr after birth in term and late-preterm neonates, and~     estimate the incidence of severe neonatal hyperbilirubinemia and the underlying causes.~      We hypothesize that the study can be value in identifying and implementing strategies for~     risk reduction.~   "
137907|NCT01762176|"~     To compare the effectiveness of two treatment strategies in early rheumatoid arthritis (ERA),~     namely the delayed usual care and early intensive care, in Hong Kong.~        -  The delayed usual care reflects the usual treatment practice in Hong Kong~        -  The early intensive care includes tight monitoring and immediate adjustment of therapy~   "
137908|NCT01762163|"~     This is a 20-week study consisting of a 12-week multicenter, randomized,double-blind adaptive~     study to compare efficacy and safety of Qizhitongluo Capsule,Naoxintong Capsule and placebo~     in the recovery phase of ischemic stroke with qi deficiency and blood stasis syndrome, and a~     8-week post-treatment safety follow-up.After 312 patients complete 12 weeks of treatment~     there will be an interim analysis.~   "
137909|NCT01762150|"~     The goal of this clinical research study is to learn the effectiveness of sorafenib combined~     with gemcitabine plus cisplatin in the treatment of patients with locally advanced or~     metastatic collecting duct carcinoma(CDC) of the kidney. The safety of each treatment will~     also be studied.~   "
137910|NCT01762137|"~     In this study, patients with large anterior circulation IAs with neck and fundus morphologies~     amenable to either traditional endovascular treatments using coils or reconstruction with the~     flow diversion will be randomly assigned to either treatment technique.~   "
137911|NCT01762124|"~     The purpose of this early feasibility study is to determine how a new transcatheter pulmonary~     valve will move and perform once implanted in the right ventricular outflow tract.~   "
137912|NCT01762111|"~     The woman fertility decrease with the age and there is a closely link with the ovarian~     reserve, the number of available eggs in the ovaries. Therefore, it is important to evaluate~     the ovarian reserve with specific marker to have a better prediction of the response of the~     in vitro fertilization treatment and to have a better rate of pregnancy.~      Until now, a lot of clinical criteria (age, duration of the infertility, number of antral~     follicles) and biological (FSH, Oestradiol, Inhibin B, EFFORT test, number of the eggs at the~     retrieval day) was suggested to help for the estimation of the ovarian reserve.~      Since couple of years, the anti-müllerian hormone (AMH) is recognize to be one of the best~     ovarian reserve marker, it corresponding the number of antral follicles, it is more sensitive~     and predictive. Moreover, during the In-Vitro Fertilization, the anti-müllerian hormone can~     provide the weak responds at the stimulation and the reverse, the risk of excessive responds~     (hyperstimulation). To choose the gonadotropin doses to administrate (stimulation ovarian~     hormone) during an In-Vitro Fertilization protocol, we need to know the anti-müllerian~     hormone dosage. However, if the anti-müllerian hormone is recognize to evaluate the quantity~     of available eggs in the ovaries, his role to determine the quality of these eggs still~     discussed.~      The goal of this study is to verify if the serum anti-müllerian hormone (blood) is a good~     indicator for the quality of the reserve ovarian evaluating the impact of anti-müllerian~     hormone rate on the pregnancy rate and implantation rate, during stimulate In-Vitro~     Fertilization protocol.~   "
137913|NCT01762098|"~     Chronic endometritis is a persistent inflammation of the endometrium. Chronic endometritis is~     asymptomatic or little symptomatic. Sometimes, patient with chronic endometritis can have~     genital bleeding, pelvic chronic pain, pain during sexual relations, persistent vaginal white~     loosing. The hysteroscopy can detect the presence or absence of chronic endometritis.~      Some studies showed that the endometritis could have an impact on the embryo implantation and~     could explain recurrent miscarriages or repeated embryo implantation failures.~      The goal of this study is to evaluate the frequency of the chronic endometritis in patients~     with recurrent miscarriages or repeated embryo implantation failures~   "
137914|NCT01762085|"~     Anecdotal reports and scientific literature suggest that the risk of recurrence of diabetic~     foot ulcers can be minimized by nerve decompression procedures at anatomic sites of nerve~     pinching and entrapment. Historical risk of 25% annually has been reported to decrease by~     >80% to under 5% yearly. Since an open wound precedes the large majority (85%) of amputations~     in diabetes, avoidance of ulcer recurrences is important. This study tests the current~     academic opinion that nerve decompression will not decrease ulcer recurrence risk. Null~     hypothesis: nerve decompression will not decrease diabetic foot ulcer recurrence risk.~   "
137915|NCT01762072|"~     Vitamin B12and n-3 polyunsaturated fatty acids (PUFA) decrease blood homocysteine (Hcy)~     concentration. However, the combined effect of these nutrients on Hcy and ferritin, and~     C-reactive protein is limited and inconclusive. The objective was to examine the synergistic~     effect of vitamin B12 in combination of n-3 PUFA on plasma Hcy, ferritin, and other~     biochemical markers. In a randomized controlled trial, thirty eligible subjects were randomly~     divided into three groups, and assigned to receive 1000 μg of vitamin B12, 2g fish oil, or~     1000 μg vitamin B12 and 2g fish oil respectively for 8 weeks. Plasma phospholipid (PL) fatty~     acids and biochemical markers were determined. we hypothesize that combination of vitamin B12~     and fish oil have synergistic effect on lowering plasma concentrations of Hcy and ferritin.~   "
137917|NCT01762046|"~     The SUGAR-MGH investigators are studying the influence of inherited gene variants on the~     response to two commonly prescribed type 2 diabetes medications, metformin and glipizide.~     They hypothesize that variants in genes that are associated with type 2 diabetes or related~     traits may impact the effect of anti-diabetic medications. In addition, physiological~     responses to an insulin secretagogue or an insulin sensitizer may shed light on the mechanism~     of action of reported genetic associations.~   "
137918|NCT01762033|"~     This Phase 2a study will investigate the efficacy, safety and tolerability of ASONEP™~     (sonepcizumab/LT1009) when administered intravenously once a week, every 4 weeks (or cycle),~     to subjects with refractory renal cell carcinoma (RCC) until the disease progresses. Subjects~     who have failed 3 prior treatments for RCC including vascular endothelial growth factor~     (VEGF) and/or mammalian target of rapamycin (mTOR) inhibitors or who have tumors that cannot~     be surgically removed will be eligible for screening.~   "
137919|NCT01762020|"~     To evaluate the effectiveness of preventing Grade II or greater radiation dermatitis induced~     by adjuvant radiation therapy in women with breast cancer.~   "
137920|NCT01762007|"~     Even successfully managed hypospadias without any complication, voiding problem could be~     developed due to the increased urethral resistance. The investigators are trying to analyze~     the effect of hypospadias operation on voiding function by checking the detrusor thickness~     and urinary nerve growth factor.~   "
137921|NCT01761994|"~     Continuous renal replacement therapy (CRRT) has been considered as an effective modality for~     renal replacement therapy in hemodynamically unstable patients within intensive care unit~     (ICU) except for the necessity of anticoagulation. The severity and peculiarities of ICU~     patients often make it equivocal to use anticoagulation. This is a prospective randomized~     controlled study to show the difference in filter life span and adverse event between HF1000~     (nafamostat mesilate) group and M100 (heparin-free) group.~   "
137922|NCT01761981|"~     The purpose of this study is to create an institutional and population-based registry of~     Haemorrhagic Hereditary Telangiectasia with a prospective survey based on epidemiological~     data, risk factors, diagnosis, prognosis, treatment, monitoring and survival.~      This study will also describe the occurrence of Haemorrhagic Hereditary Telangiectasia in the~     population of HIBA in the Central Hospital, as well as the characteristics of clinical~     presentation and evolution.~   "
137923|NCT01761968|"~     This is a multicenter, open label, long-term study testing the long-term safety, tolerability~     and efficacy of Givinostat in patients with Polycythemia Vera, Essential Thrombocythemia,~     primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, Post-Essential Thrombocythemia~     Myelofibrosis following core protocols in chronic myeloproliferative neoplasms and/or~     patient-named compassionate use program (if regulated/allowed by the local regulations, e.g.~     for Italy D.M. 8/5/2003 Uso terapeutico di medicinale sottoposto a sperimentazione clinica~     published on G.U. n. 173 of 28 July 2003, and the following amendments). Patients will~     continue at their last tolerable dose and treatment schedule of Givinostat monotherapy. If~     patients previously received Givinostat in combination with other drugs during a core~     protocol or a compassionate use program (if regulated/allowed by the local regulations, e.g.~     for Italy D.M. 8/5/2003 Uso terapeutico di medicinale sottoposto a sperimentazione clinica~     published on G.U. n. 173 of 28 July 2003, and the following amendments), they will be treated~     at the last tolerable dose of the combination. Assessment of safety and efficacy will be~     performed at each quarterly visit and each visit will also include laboratory tests and ECG~     examination. During the visits the clinical benefit will be assessed by Investigator~     according to the revised European LeukemiaNet response criteria (for PV and ET) and EUMNET~     response criteria (for MF). The dose of Givinostat will be modified for protocol specified~     toxicities. The treatment may continue up to Marketing Authorization of Givinostat, currently~     planned in the next 5 years (note: only for Germany, this long-term study is initially~     limited up to 2 years of treatment). Patients may discontinue study treatment at any time and~     remain on study therapy as long as they derive clinical benefit. Safety will be monitored at~     each visit throughout the entire duration of the study. In case the approved label will not~     cover the whole study population, Givinostat will be provided by the Sponsor to those~     patients not fulfilling the criteria for the approved label of the drug that are still~     deriving benefit from Givinostat at the time of its commercial availability.~   "
137924|NCT01761955|"~     The purpose of this study is to evaluate the effects of regular low fat diary consumption on~     markers of cardiovascular (CV) and metabolic (cardiometabolic) health including body~     composition (% body fat, body weight), blood lipids, blood glucose, arterial compliance,~     blood pressure, insulin sensitivity and resting metabolic rate.~   "
137925|NCT01761942|"~     The purpose of this study is to determine whether omega -3 fatty acids are effective and safe~     in treating anorexia nervosa.~   "
137926|NCT01761929|"~     This is a prospective Phase II study.The purpose of this study is to monitor the side effects~     and treatment outcomes of delivering higher doses of radiation therapy to the tumour, while~     limiting the dose of radiation to the normal tissues. This will be done using a 5 day~     treatment schedule.~      The characteristics of patients whose disease remains confined to limited areas in the long~     term, compared with those who do not will also be described.~   "
137927|NCT01761916|"~     The postpartum period represents a stage of the pregnancy-puerperal still rarely addressed~     scientifically. There are no reports in the literature and concrete enough to elucidate~     important issues, especially in the field of hypertension and pregnancy.~      Searches based on current evidence concentrate their focus on the diagnosis of hypertensive~     disorders and treatment of these diseases maternofetais repercussions. However, the prognosis~     in the short and long term, as the BP outcome in mothers with severe preeclampsia, the most~     effective treatment for the control of hypertensive crisis and metabolic and cardiovascular~     events after two years of termination of pregnancy require further clarification.~      The main idea for developing this research came from the clinical experience with the use of~     captopril in Obstetric ICU IMIP. This drug has long been used in postpartum women with severe~     preeclampsia or chronic hypertension exacerbated by pregnancy for control of hypertensive~     crisis and keeping pressure levels. Following the technical standards of the institution and~     during his administration, there were reports of side effects such as dry cough and nausea,~     beyond the threshold dose of 150mg daily captopril was easily achieved hindering control the~     use of hypotensive.~      Alternative therapy, clonidine began to be used in mothers with some restriction on the use~     of ACE inhibitors and its hypotensive effect for peak pressure was satisfactory. What is not~     known yet is how long clonidine reduces high blood pressure and how long to leave stabilized~     compared to the use of captopril.~      There are no reports in the literature databases, no randomized clinical trials that prove~     the effectiveness of clonidine for the treatment of hypotensive pressure peaks in this~     particular group of patients, even in comparison with other classes of antihypertensive~     drugs, especially captopril, to this purpose.~      The investigators' primary assumption is that clonidine has better effectiveness in~     decreasing the frequency of pressure peaks when compared with captopril.~   "
137928|NCT01761903|"~     In this study we are looking at primary focal dystonias, including dystonias of the limbs,~     eyes, jaw or face, neck, and vocal chords. This study will use magnet resonance imaging (MRI)~     to see how the brain reacts while resting and doing a finger-tapping task.~      The investigators will test the hypothesis that disturbances in functional connectivity~     within the motor, affective and cognitive basal ganglia networks in primary focal dystonia~     (PFD) underlie the motor and non-motor symptoms in this disorder.~   "
138039|NCT01760460|"~     This study will evaluate the effects of anacetrapib (MK-0859) on low-density~     lipoprotein-cholesterol (LDL-C) when compared to placebo in Japanese participants with~     dyslipidemia when added to an existing statin-modifying therapy.~   "
137929|NCT01761890|"~     The GIMEMA CML Working Party promotes a multicentric, observational, non company sponsored,~     prospective study of Chronic Myeloid Leukemia (CML) patients treated frontline with~     dasatinib. Patients will be followed for 5 years. This study will help the definition of~     guidelines for the treatment of CML patients in early phases.~      The primary objective of the study is to describe, in the clinical practice, the rate of~     events leading to permanent discontinuation after 2 years of treatment with dasatinib as~     frontline therapy in newly diagnosed CML patients.~   "
137930|NCT01761877|"~     This study has two purposes. One is to determine if daily sulindac decreases breast density;~     a risk factor for breast cancer development. The second is to determine whether sulindac~     reduces pain and stiffness associated with regular use of aromatase inhibitors given for the~     treatment of breast cancer.~   "
137931|NCT01761864|"~     Osteoarthritis is a common problem in primary care. Long-term use of non-steroidal~     anti-inflammatory drugs (NSAIDs) for pain relief can lead to serious (gastro-intestinal,~     cardiovascular and renal) adverse events, that can even result in death. NSAIDs differ in~     their risk of side effects. Opoid analgesics are sometimes used as an alternative for NSAIDs~     in patients with osteoarthritis. However, these drugs also can lead to serious adverse~     events. Simple analgesics are first line treatment in patients with osteoarthritis. NSAIDs~     and opoid analgesics should be avoided whenever possible.~      Farmaka (www.farmaka.be) is a non-profit organisation that operates a nationwide academic~     detailing service in Belgium since 2006. The academic detailing exists of face-to-face~     educational visits to general practitioners in their practice by a trained visitor with a~     medical science degree. The aim of these visits is to improve the quality of drug prescribing~     in primary care. Small scale experiments in the past showed that academic detailing can~     indeed improve prescribing behavior.~      The current study wants to examine if nationwide academic detailing on appropriate~     prescribing of analgesics for chronic pain in osteoarthritis results in a better GP's~     prescribing behavior.~      Another research question is whether physician-visitors have more influence on prescribing~     than non-physician visitors.~      It is also interesting to examine if the effect of a visit is larger if there exists a~     longstanding relationship between the academic detailer and the GP.~      About 4.000 general practices are located in a region where academic detailers of Farmaka are~     operational and have received a visit at least once before. All these practices will be~     divided into two study groups in a random manner.~      The first group of practices will belong to the treatment group. GP's from this group will be~     offered a face-to-face visit on appropriate prescribing of analgesics for chronic pain in~     osteoarthritis. The visits will take place between February and June 2013.~      The second group of practices will serve as a control group. GP's from these practices won't~     be offered any visit at all during the year 2013.~      Reimbursement data for all GP's are available by request from the Belgian Intermutualistic~     Agency (IMA). IMA data for 2013 will be available by the end of 2014. These data will allow~     comparison between the treatment and control group on the amound and type of prescriptions~     for analgesics in patients with chronic osteoarthritis pain.~      A comparison of the prescriptions of practices that participate in the study and the~     prescriptions of in practices that don't participate is also possible.~      The project is funded by the Federal Agency for Medicines and Health Products. We hypothesize~     that~        -  the academic detailing visits to GP practices on prescribing of analgesics for chronic~          pain in osteoarthritis will improve prescribing of analgesics by at least 5%~        -  the personal relation between the GP and the academic detailer, expressed as the number~          of previous visits, is an important effect modifier~   "
137932|NCT01761851|"~     Metabolic disorders and malnutrition are well known and have been reported in patients with~     chronic liver disease, but the relationship of energy metabolism and changes in nutritional~     status in patients on the waiting list for liver transplantation are unexplored. The aim of~     this study was to assess the resting energy expenditure (REE) of these patients, identifying~     the prevalence of hyper and hypometabolism. In addition, to assess if, malnutrition and~     clinical variables were associated with REE and metabolic disorders.~   "
137933|NCT01761838|"~     The purpose of this study is to compare changes in spinal stiffness and back muscle activity~     between spinal manipulative therapy (SMT) responders, non-responders and asymptomatic~     participants. Additionally, the investigators wanted to compare the amount of lumbar~     degeneration between SMT responders, non-responders and asymptomatic participants. This study~     also determines if the presence of pain modifies post-SMT spinal stiffness and back muscle~     activity.~   "
137934|NCT01761825|"~     The purpose of this study is to determine whether Ivabradine is an effective treatment for~     postural tachycardia syndrome.~   "
137935|NCT01761812|"~     The purpose of this study is to determine the ability of several new MRI techniques (MR~     elastography, dynamic contrast-enhanced MRI with gadofosveset, and oscillating gradient~     diffusion) to determine the location, size, and grade of prostate carcinoma. Thirty patients~     with biopsy proven carcinoma awaiting prostatectomy will be included in the study. Ex-vivo~     MRI will also be conducted on the prostate specimen to obtain high resolution imaging~     correlates to both in-vivo MRI and whole mount prostatectomy specimens. The investigators~     hypothesize that the addition of these three techniques will increase the accuracy,~     sensitivity, and specificity of MRI for detecting clinically significant prostate cancer.~   "
137936|NCT01761799|"~     The primary research aim of this project is to test the effectiveness of a comprehensive,~     evidence-based vaccine promotion package implemented in the obstetric setting on increasing~     the likelihood that a pregnant woman in Georgia will receive an influenza and/or pertussis~     vaccine.~   "
137937|NCT01761786|"~     Rationale: the use of antiplatelet drugs (i.e. clopidogrel, ticagrelor or prasugrel) is~     crucial in the treatment of patients undergoing percutaneous coronary intervention (PCI) with~     stent implantation to prevent atherothrombotic events. Ticagrelor and prasugrel are more~     effective in preventing atherothrombotic events, but with a higher risk of bleeding~     complications, compared to clopidogrel. Clopidogrel is converted into its active metabolite~     by CYP2C19. Carriers of the non functional CYP2C19*2 and *3 alleles have an impaired CYP2C19~     capacity, making clopidogrel less effective. For these subjects ticagrelor or prasugrel is an~     alternative.~      Objective: to assess the efficacy, safety and cost-effectiveness of the CYP2C19 genotype~     guided antiplatelet treatment strategy, using clopidogrel in non-carriers of a CYP2C19*2 or~     *3 allele and ticagrelor or prasugrel in carriers of a CYP2C19*2 or *3 allele in STEMI~     patients.~      Intervention: the intervention group will be genotyped for CYP2C19*2 and *3 allele variants~     within 48 hours after primary PCI. Carriers will receive either ticagrelor (90 mg twice~     daily) or prasugrel (10 mg once daily or 5 mg once daily if the patient is older than age 75~     or has a body weight less than 60 kg), according to local standards. Non-carriers will be~     treated with clopidogrel (75 mg once daily). The control group receives either ticagrelor or~     prasugrel, according to local standards at the same dosage as the CYP2C19*2 or *3 carriers in~     the intervention group. The antiplatelet drug will be continued for one year after PCI. The~     follow-up duration will be one year using follow-up questionnaires.~   "
137938|NCT01761773|"~     The main objective of the trial is to compare the pharmacokinetics of a 60 mg dose of~     cabozantinib in adult subjects with impaired renal function compared with healthy adult~     subjects. Another objective is to assess the safety and tolerability of cabozantinib in these~     adult subjects.~   "
138098|NCT01759693|"~     Platelets are blood cells that are important in coagulation of the blood. These cells have~     recently been shown to play a role in a number of other biologic processes, for example~     inflammation. In this study the investigators will determine the extent of platelet~     activation in people suffering from common chronic skin inflammation-urticaria and allergic~     dermatitis.~   "
137939|NCT01761760|"~     Investigators will be evaluating an online video-game-based smoking cessation intervention~     that will overcome barriers to treatment such as cost and sustainability. This videogame will~     be the first of its kind, based on an evidence-based intervention shown to promote smoking~     abstinence. The findings from this research will be of great public health significance~     because of the unprecedented reach and relatively low cost, as well as the potential for~     similar interventions to be developed for other health problems, such as alcohol or drug~     abuse and medication adherence for chronic illnesses~   "
137940|NCT01761747|"~     This research study is a Phase II clinical trial, which tests the safety and effectiveness of~     an investigational drug to learn whether the drug works in treating a specific cancer.~     Investigational means that the drug is being studied. It also means that the FDA has not~     yet approved ponatinib for use in patients, including people with your type of cancer.~      In order to participate on this study, it must first be determined whether or not a patient's~     lung or head and neck squamous cell cancer (SCC) has an alteration in FGFR kinase is made~     from an experimental test on your squamous cell cancer tissue sample. This experimental test~     is a genetic test or genotyping test, which is a method used to study a tumor's genes.~     The results are for research purposes only and are not considered genetic testing for the~     purpose of diagnosing medical conditions. Cancers develop as a result of changes that occur~     in human genetic material (DNA); these changes are called mutations or alterations. This~     experimental test gives no information about any of the genes in the normal cells of the~     patient's body, but it helps identify abnormal genes (like FGFR kinase mutations or~     alterations) usually found only in cancer cells. We will use this experimental test to~     determine whether or not a tumor contains a required alteration/mutation and thus may respond~     to ponatinib.~      Ponatinib is an investigational, oral anti-cancer drug designed to inhibit abnormal proteins~     found in cancer cells and may cause those cancer cells to die. In laboratory testing,~     ponatinib has been shown to inhibit a family of proteins called FGFR kinases, and this~     genetic alteration/mutation has been found in some squamous cell lung cancers. There is~     laboratory evidence that alterations/mutations in FGFR kinases in squamous cell lung cancers~     may be driving the growth of these tumors and that inhibiting these FGFR kinases with~     ponatinib may decrease or stop the growth of lung SCC.~      In this research study, we are looking to see if the study drug, ponatinib, can keep cancer~     from growing.~   "
137941|NCT01761734|"~     Influenza is an important and potentially preventable cause of morbidity and mortality, yet~     only 46% of U.S. adults were vaccinated by the end of the 2011-12 influenza season despite~     influenza vaccination being widely recommended, effective, and safe. Influenza vaccination~     rates are even lower in racial/ethnic minority groups. In order to address the problem of low~     influenza vaccination rates in minority adults, we plan to build on the well-accepted~     practice of immunization recall-reminders and the emerging practice of using text message to~     pilot the feasibility of using text messaging to improve influenza vaccination coverage rates~     in a low health literacy, largely minority, publicly insured adult population.~   "
137942|NCT01761721|"~     The propose of this study is to describe recovery and experience of pain and health related~     quality of life after robot-assisted laparoscopic hysterectomy for women with Endometrial~     Cancer or Atypical Complex Hyperplasia.~   "
137943|NCT01761708|"~     Ventral hernias, such as umbilical, epigastric and trocar-site hernias, are best repaired~     with abdominal wall reinforcement by mesh implantation. Mesh-devices using a dual-sided mesh~     technology have been developed for the specific indication of small ventral hernias; this~     technique is very attractive because the mesh can be introduced through a nearly invisible~     scar in the umbilicus. The dual layer of the mesh inhibits the formation of adhesions of the~     viscera to the mesh so, if wanted, it can be positioned in a intraperitoneal position. No~     literature is available on the adequate size of mesh needed to repair a hernia defect of an~     umbilical or epigastric hernia. Very small hernias are now often enlarged for repair with a~     large mesh device. Small hernias might benefit of repair with a small mesh device so no~     enlargement of the defect is necessary Larger hernias might benefit from a larger mesh size~     to have more overlap of the mesh beyond the hernia defect. The SITUP-trial was a prospective~     cohort study who was designed to explore the efficacy of C-QUR V-Patch of different sizes for~     the different sizes of hernia defects. The study was stopped prematurely because of the~     perception of an unacceptably high rate of mesh infection. This new study will~     retrospectively examine the incidence of mesh infection in all ventral hernias repaired with~     a C-QUR V-Patch. Collection of patient data was done using the Eura-HS registry.~   "
137944|NCT01761695|"~     The investigators would like to propose a prospective longitudinal observational cohort study~     for patients who will be diagnosed and/or treated for chronic myeloid leukemia at Asan~     Medical Center, Seoul, Korea, to use the acquired data for fundamentals of other~     retrospective analysis.~   "
137945|NCT01761682|"~     The investigators would like to propose a prospective longitudinal observational cohort study~     for patients who will be diagnosed and/or treated for acute lymphoblastic leukemia at Asan~     Medical Center, Seoul, Korea, to use the acquired data for fundamentals of other~     retrospective analysis.~   "
137946|NCT01761669|"~     Working hypothesis and aims: The aim of our study is to investigate whether vitamin D~     deficiency could cause increased thrombin generation and a hypercoagulable state healthy~     volunteers.~      Methods:~      In total 400 healthy volunteers are planned for inclusion in this trial. After signing an~     informed consent two blood samples will be obtained from each participant.~      Expected results: invastigator expect to find that volunteers with vitamin D deficiency will~     have thrombin generation curve compatible with hypercoagulable state and returning to normal~     after treatment with vitamin D~   "
137947|NCT01761656|"~     The purpose of this study is to determine whether preoperative loading dose atorvastatin can~     prevent perioperative myocardial infarction during angiography and main adverse cardiac~     events 1 month after operation in stable angina, unstable angina and acute non-ST-segment~     elevation myocardial infarction patients undergoing elective coronary angiography and PCI,~     and determine whether its mechanisms are associated with microcirculation resistance.~   "
137948|NCT01761643|"~     CCTG 595 is a controlled, open-label, two-arm, randomized (1:1) clinical demonstration~     project to determine if the use of a text-message based adherence intervention (iTAB)~     improves retention and adherence to PrEP compared to standard of care (SoC) PrEP delivery.~   "
137976|NCT01761279|"~     Current standard practice is to remove all colonic polyps found during colonoscopy as it has~     not been possible to distinguish between polyps with some malignant potential (adenomatous)~     and those with negligable malignant potential (non-adenomatous).~      Recent advances in endoscope imaging and technology have allowed endoscopists to distinguish~     between these two types of polyps by examining minute surface details.~      i-Scan is a new digital enhancement method that aims to enhance surface details and may~     enable similar accurate distinction between adenomatous and non-adenomatous polyps.~      Hypothesis:~      High definition white light endoscopy plus i-Scan improves diagnostic accuracy of in-vivo~     assessment of colonic polyps <10mm in size over high definition white light endoscopy alone.~   "
137949|NCT01761630|"~     Asthma is a disease characterized by inflammation in the airways. The body naturally makes~     compounds that reduce inflammation. Unfortunately, for patients with severe asthma, the~     pathway these compounds use to reduce inflammation seems to be perturbed. Investigators have~     chosen to focus on the anti-inflammatory compounds called lipoxins and how they work through~     the ALX Axis, a name given to the ALX receptor pathway and its ligands. Work from the~     Brigham and Women's Hospital has suggested that in patients with severe asthma, the ALX axis~     may not work properly and therefore may not shut off inflammation as expected. Also, there is~     information to suggest that in some cases, steroids (prednisone and similar drugs), which are~     commonly used to treat asthma, may affect the ALX axis in a negative way, paradoxically~     making the inflammation worse instead of better.~      As part of the NIH Severe Asthma Research Program the Asthma Research Center's goal is to~     identify what causes the problems in the ALX axis in severe asthma. To do so, participants~     with severe asthma will be compared to participants with milder forms of asthma.~     Investigators will use samples taken directly from the lungs of people with asthma, as well~     as blood, urine and CT scans of the lungs to better understand how the ALX axis changes both~     before and after corticosteroid treatment and throughout a three year span. Participants will~     come into the Asthma Research Center to have the procedures done.~      Investigators expect participants will perform breathing tests and complete questionnaires~     and diaries. To better understand if corticosteroids negatively affect the ALX axis in severe~     asthma, researchers will take samples before and after a one time steroid injection~     equivalent to a prednisone treatment for asthma. Participants will perform two bronchoscopy~     procedures, before and after corticosteroid treatment, where biopsies and cells will be~     obtained from the participant's lungs. Investigators will use these samples to observe any~     changes that the corticosteroid may have on the ALX axis. At the end of the study,~     researchers at the Brigham and Women's Hospital expect to understand the ALX axis in such a~     way that will allow them to formulate new therapies and drug targets to treat people with~     asthma, especially severe asthma, more effectively.~      In Boston, this study will be run together by the Asthma Research Center at the Brigham and~     Women's Hospital (adults) and Boston Children's Hospital (children).~   "
137950|NCT01761617|"~     A 12-week randomized controlled trial (RCT) for chronic low back pain in predominantly~     minority populations comparing yoga classes once/week vs. twice/week. Primary outcomes are~     pain intensity and measure of disability; secondary outcomes are pain medication use,~     treatment adherence, and health-related quality of life.~   "
137951|NCT01761604|"~     The pain from Trigeminal Neuralgia (TN) imposes a substantial burden on patients in daily~     function and reduces quality of life. The sphenopalatine ganglion, located in the posterior~     part of the middle nasal turbinate, is involved in the pain associated to TN, by blocking the~     sphenopalatine ganglion relieves patients from the symptoms. However, methods currently in~     use to accomplish this are either cumbersome for the patient or invasive regarding the~     puncture of structures.~      The purpose of this study is to evaluate the efficacy of Tx360™, a new nasal applicator~     device, in the treatment of TN. A local anesthetic will be delivered on the ganglion area. We~     are expecting that this new device will provide at least the same pain relief as the~     previously described approaches. However, this nasal applicator is intended to be an easy and~     non invasive method for office use.~   "
137952|NCT01761591|"~     The purpose of this randomized controlled trial (RCT) is to demonstrate the clinical benefit~     and impact on resource utilization of percutaneous coronary interventions (PCI) with the~     Svelte Acrobat Stent System compared to any other CE marked bare metal stent (BMS)~     implantable via direct stenting or after lesion pre-dilation, in patients with coronary~     lesions that are eligible for direct stenting and who are recruited and treated so as to~     reflect real-life routine practice.~   "
137953|NCT01761578|"~     This prospective, multicentre, open labeled, single arm, first in man interventional~     investigation aims to evaluate the safety of the ART18Z bioresorbable stent for the treatment~     of patients with single de novo lesion of a native coronary artery with mandatory balloon~     predilatation.~   "
137954|NCT01761565|"~     Determine the plasma concentration profile after single and multiple dosing of Sufentanil~     NanoTabs~   "
137955|NCT01761552|"~     To demonstrate that the use of Sugammadex enables physicians to perform early extubation in~     the operating room in ASA 4 & 4E patients~      Primary endpoint:~      • Extubation in the operating room before transfer to the PACU or ICU versus keeping the~     patient intubated when transferred.~      Secondary endpoints:~      • Time to extubation - measure the difference in time from application of the surgical~     dressing until extubation. Atelectasis - comparison of chest x-rays (CXR): prior to surgery,~     on admission to PACU or ICU and 24 hours after admission to PACU or ICU (This is the routine~     practice at Hadassa hospital for ASA IV patients.)~   "
137956|NCT01761539|"~     Fluid resuscitation for pancreatitis is recommended given evidence that hemoconcentration is~     associated with necrosis. However, there is insufficient evidence to support whether~     resuscitation should be moderate or aggressive. In this study the investigators aim to~     compare the clinical outcome associated with these strategies in a clinical randomized~     fashion to determine the optimal treatment of acute pancreatitis.~   "
137957|NCT01761526|"~     To investigate the Pharmacokinetics (PK) of transdermally delivered Rotigotine in Japanese~     and Caucasian Female and Male Healthy Subjects.~   "
137958|NCT01761513|"~     A clinical Study to evaluate the safety and pharmacokinetics/pharmacodynamics(PK/PD) of~     YH4808 after repeated Oral administration and Postprandial state in healthy volunteers~   "
137959|NCT01761500|"~     Non-Hodgkin's lymphoma is an aggressive malignance disease in children and adolescents. This~     study was designed to evaluate the efficacy and toxicity of the modified NHL-BFM-90 protocol~     in Chinese children and adolescents with Non-Hodgkin's lymphoma.~   "
137960|NCT01761487|"~     There is an urgent need to control the current national outbreak of Carbapenem-resistent~     Klebsiella pneumonia (CRKP). In Israel, the death rate among CRKP carriers is 3.5 times~     higher than in Carbapenem-sensitive Klebsiella pneumonia carriers (44% vs. 12.5%,~     respectively).~      In the investigators' previous study: A Randomized, Double-Blind, Placebo-Controlled Trial of~     Selective Digestive Decontamination (SDD) Using Oral Gentamicin and Oral Polymyxin E for~     Eradication of CRKP Carriage (Infect Control Hosp Epidemiol. 2012;33:14-19) the investigators~     have shown that the investigators' SDD regimen is effective for decolonization patients~     colonized with CRKP.~      The investigators' assumption is that a higher dose of polymyxin E together with gentamicin~     (SDD drugs) for a prolonged period is needed to overcome the likelihood of a high rate of~     drug inactivation in the gut, thereby reaching CRKP carriage eradication.~   "
137961|NCT01761474|"~     Endoscopic retrograde cholangiopancreatography(ERCP) and related procedures can cause~     abdominal pain and discomfort. Some clinical trials have indicated, using the visual analogue~     scale (VAS) score, that CO2 insufflation during ERCP ameliorates the suffering of patients~     without complications, compared with air insufflation. However, differences in patient~     suffering between CO2 and air insufflation after ERCP depending on sedation protocols have~     not been reported. We therefore planned prospective, double-blind, randomized, controlled~     study with CO2 and air insufflation during ERCP depending on sedation protocol.~   "
137962|NCT01761461|"~     The optimal regimen for adjuvant treatment has not been established in GC yet. We plan to~     compare TS-1, TS-1/oxaliplatin with or without RT in D2 resected gastric cancer.~   "
137963|NCT01761448|"~     The object of this study is to determine the improvement obtained in long-term adherence to~     home-based rehabilitation programs (cardiac rehabilitation phase III) when following a guided~     exercise training prescription supervised by an innovative system specifically designed to~     optimize the training effects and maximize the patient´s security compared to the standard~     care given in each country for this kind of patients. The innovated Guided Exercise- (GEx)-~     System consists of a sensor that monitors vital parameters during exercise training sessions~     used in combination with software that provides feedback to the patient based on the training~     prescription provided by the doctor and the level exertion monitored. This main trial follows~     a pretrial in which the used ECG sensor was validated at hospital during rehabilitation phase~     II and the practicability of the vest with this integrated ECG sensor and the possibility of~     technical problems of this innovative GEx- system were tested in real-life of the patient~     during phase III at home (ID 11-094).~   "
137964|NCT01761435|"~     Randomized, multicenter, open label trial to compare safety and efficacy of two doses~     stationary flu vaccination vs one doses in Solid Organ Transplant Recipients.~   "
137965|NCT01761422|"~     The goal is to assess for myocardial edema on cardiac MRI during SLE flare to assess for~     myocardial inflammation.~   "
137966|NCT01761409|"~     Endometrial cancer is one of the most common gynecological cancers, and the incidence~     increasing in the world. However, there isn't any large sample data of endometrial cancer~     reported in China. Thus Endometrial cancer project of Guangdong province conduct a large~     multicentre clinical investigation about endometrial cancer.~   "
137967|NCT01761396|"~     This research is being done to compare two types of talk therapy to see which is most~     effective in helping school children with anxiety disorders. The investigators will compare~     usual care (UC) with cognitive behavioral therapy (CBT). Both therapies will be administered~     by the school mental health counselors to see if they help children with anxiety disorders to~     feel less scared or worried.~   "
137968|NCT01761383|"~     The purpose of this study is to determine whether the use of Nintendo Wii will help improve~     negative symptoms of Schizophrenia and quality of life of patients with chronic~     Schizophrenia.~   "
137969|NCT01761370|"~     The study will determine the feasibility of using Bioenteric intragastric balloon (BIB) in~     the treatment of patients with Non alcoholic Steatohepatitis (NASH).~   "
137970|NCT01761357|"~     The aim of the study is to determine whether the burden of comorbidities measured by CIRS-G~     (Cumulative Illness Rate Scale) is associated with a non-amelioration of the health related~     quality of life measured by questionnaire called SF-36, six months after a transcatheter~     aortic valve replacement in older patients. During the comprehensive geriatric assessment~     realized before the valve implantation, the following data are recorded and their impact of~     the health related quality of life will also be analysed: comorbidity, age, depression,~     functional status, the cognitive impairment and malnutrition.~   "
137971|NCT01761344|"~     Aldosterone is a hormone produced in the adrenals that helps regulate the salt balance and~     blood pressure. Primary hyperaldosteronism is one of the main endocrine causes of secondary~     hypertension. The overproduction of aldosteron might in some cases be due to unilateral~     hyperplasia of the adrenal cortex or a unilateral aldosterone-producing adenoma. In these~     cases the adrenal can be removed and the patient cured of hypertension. The clinical~     evaluation of patients with confirmed primary hyperaldosteronism therefore includes selective~     sampling of blood from the adrenal veins to determine lateralization of overproduction. This~     is executed as an interventional radiological procedure.~      The adrenal vein sampling is challenging, and success is determined by measuring another~     adrenal hormone named cortisol in the blood samples as a marker of a correctly drawn sample.~     By routine laboratory assays the procedure is evaluated after the patient has been discharged~     from the hospital. In the study a rapid assay of cortisol will be evaluated, allowing the~     radiologist to draw new samples during the same procedure if the first set of samples is~     unsuccessful. The study hypothesis is that intraoperative measurement of cortisol is a useful~     tool to evaluate successful sampling, and that fewer patients will need a repeated procedure.~   "
137972|NCT01761331|"~     The purpose of this prospective randomized three armed, multi center study is to compare the~     effect of two types of acupuncture and no acupuncture in 2-8 weeks old infants with infantile~     colic. Group A will get standardized minimal acupuncture in LI4, group B will get~     individualized acupuncture in different points according to symptoms and group C will not get~     acupuncture. Parents (who register the infants crying) and the nurse they meet at the study~     CHC are blinded.~   "
137973|NCT01761318|"~     The most important cause of mortality amongst DM2 patients is cardiovascular disease. An~     early finding of cardiovascular disease in DM2 and obesity is diastolic dysfunction.~     Diastolic dysfunction is an independent predictor of mortality and has been shown to improve~     in patients on a low calorie diet. The improvement of diastolic function was associated with~     a reduction in triglyceride accumulation in the heart and liver. A relatively new widely~     prescribed therapeutic agent for DM2 patients is Liraglutide (Victoza®). Liraglutide is a~     Glucagon Like Peptide - 1 homologue that improves glucose homeostasis and reduces blood~     pressure and body weight. Next to the induction of weight loss, which is potentially~     beneficial for cardiac function, GLP-1 therapy might have a direct advantageous effect on the~     cardiovascular system. However, the effect of Liraglutide on cardiovascular function has not~     been investigated yet. The investigators hypothesize that treatment of DM2 patients with~     Liraglutide is associated with improvement of cardiovascular function and a reduction of~     triglyceride accumulation in end-organs.~   "
137974|NCT01761305|"~     Idiopathic scoliosis is a three-dimensional structural deformity of the spine that occurs in~     children. Recent reviews on bracing and exercise treatment have provided some evidence for~     effect of these interventions. The purpose of this study is to compare the effectiveness of~     night time bracing, scoliosis specific exercises and physical activity prescription in~     adolescents with idiopathic scoliosis.~   "
137975|NCT01761292|"~     This is a 2-part, phase 2 study to assess the effects of Givinostat on muscle histologic~     parameters and on clinical parameters in ambulant children with DMD. The safety,~     tolerability, and pharmacokinetics of Givinostat will also be assessed. All children treated~     in part 2 continue in the extension phase, for a maximum of an additional 12 months.~   "
137978|NCT01761253|"~     This study will involve the evaluation of the cost profile of about approximately 241,000~     patients (15,000 who are members of the Generations Plus/ Northern Manhattan Health Network~     AND 226,000 members of a large self insured union trust fund). We will test the hypothesis~     that as comorbidity scores exceed three-four, patients will have an exponential increase in~     average yearly cost with a parallel exponential increase in cost variability.~      We will examine the relationship between comorbidity and health insurance costs and~     variability in costs among patients enrolled in health plans.~   "
137979|NCT01761240|"~     This study is a Phase I, first in human, dose-escalation study of MORAb-066, an~     investigational humanized immunoglobulin G (IgG) monoclonal antibody (mAb) that targets~     TF-expressing malignancies that include breast, pancreatic, colorectal, and non-small-cell~     lung cancer (NSCLC) (adenocarcinoma). This open-label study will assess the safety,~     tolerability, and pharmacokinetics of MORAb-066 administered weekly. This study will identify~     the MTD when MORAb-066 is administered IV once weekly on a 28-day cycle.~   "
137980|NCT01761227|"~     Purpose: The purpose of this study is to examine the efficacy and safety of Fufangdanshen~     Tablets in patients with mild to moderate vascular dementia (VaD).~   "
137981|NCT01761214|"~     Bronchiectasis is a chronic disease arises from progressive airway inflammation and~     infection. It has been postulated that bacterial infection triggers intense airway~     inflammation leading to acute exacerbation of bronchiectasis. Antibiotics have been the most~     potent medications for the treatment of bronchiectasis, however, the sputum bacterial load~     and inflammatory indices at steady-state and exacerbation remain largely unknown. The~     investigation might shed light on the roles that antibiotics play in acute exacerbation of~     bronchiectasis and uncover the mechanisms on why a subgroup of individuals do not respond~     satisfactorily.~   "
137982|NCT01761201|"~     A multicenter, prospective, non-inferiority, randomized and open clinical trial comparing~     levofloxacin with isoniazid in the treatment of latent tuberculosis infection in patients~     eligible for liver transplantation.~      Patients over 18 years of age on the waiting list for liver transplantation.~      Sample size: n=870 patients.~      HYPOTHESIS~      Levofloxacin treatment of latent tuberculosis infection, begun while on the waiting list for~     liver transplantation, is safer and not less effective than isoniazid treatment begun after~     transplantation when liver function is stable.~   "
137983|NCT01761188|"~     -  Background:the ablation outcomes for the treatment of persistent atrial fibrillation are~          not as satisfactory as paroxsymal AF. The successful rate ranges from 30%-55%. We found~          a new novel strategy for the modification of LA substrate during sinus rhythm based on~          our pilot study.~        -  Hypothesis: our new method may be more effective than conventional strategy.~        -  Objectives:The primary objective of this investigation is to compare the efficacy of two~          different AF ablation strategies in patients with persistent AF:Study Group: CPVI plus~          electrophysiologic substrate ablation in the left atrium during sinus rhythm (~          STABLE-SR);Control Group: conventional stepwise approach for persistent AF(CPVI + Lines~          +CFE) .The secondary objectives of this investigation are to evaluate and compare the~          safety and procedural characteristics of both groups.~        -  Sample size: 220~        -  Time line: 2013 Q1-2014 Q2~   "
137984|NCT01761175|"~     The purpose of this study is to compare the rate of complete sensory block at 30 minutes~     following ultrasound-guided single injection infraclavicular block and ultrasound-guided~     double injection axillary block. The investigators research hypothesis is that both blocks~     will show comparable rates of complete sensory block at 30 minutes.~   "
137985|NCT01761162|"~     The objective of the ProMRI Study is to demonstrate the clinical safety of the ProMRI~     Pacemaker System when used under specific MRI conditions.~   "
137986|NCT01761149|"~     Extensive clinical studies have shown that intraoperative infusion high dose of remifentanil~     (0.2ug/kg/min) induced postoperative hyperalgesia. Recent experimental study however suggests~     that higher dose of remifentanil may attenuate postoperative hyperalgesia. Thus, the present~     study is designed as a proof of principle study and hypothesizes that higher dose of~     remifentanil may reduce postoperative pain in patients.~   "
137987|NCT01761136|"~     The objective of this study was to evaluate the safety and immunogenicity of Haemophilus~     influenzae type b vaccine in different injection site.~   "
137988|NCT01761123|"~     the purpose of the study is to determine the safety and tolerability of VXA-A1.1, an~     adjuvanted adenoviral based influenza vaccine, when delivery is targeted to the ileum, using~     a radio controlled capsule. The secondary objective is to evaluate the immune response~     (cellular and humoral) of two doses of VXA-A1.1 oral vaccine.~   "
137989|NCT01761110|"~     The main goal of this study is to pilot test the community-based buprenorphine treatment~     (CBBT) intervention, examining buprenorphine treatment initiation, opioid use, and HIV risk~     behaviors. Two groups of participants will be followed for 60 days, with 3 research visits.~     One group will be enrolled prior to the CBBT intervention (pre-intervention), and one group~     after the CBBT intervention (post-intervention). Data sources will include questionnaires,~     urine toxicology tests, and medical record data. Investigators hypothesize that compared to~     the participants in the pre-intervention group, participants in the post-intervention group~     will be more likely to initiate buprenorphine treatment, reduce opioid use, and reduce~     high-risk HIV risk behaviors.~   "
138004|NCT01760915|"~     The overall goal of this proposal is to better understand the basis of structural airway~     changes in severe asthma and how asthma exacerbations may contribute to their progression~     over time. The investigators propose to study a well-characterized cohort of adult and~     pediatric subjects with asthma using a multidisciplinary state-of-the-art approach. We~     hypothesize that severe asthma exacerbations, in some patients, are associated with~     incomplete recovery and activation of airway inflammatory cells in a regional distribution.~     The end result is a more permanent and less reversible airway obstruction that is a prominent~     feature of severe asthma.~   "
138005|NCT01760902|"~     South Carolina has many gaps in health status of our citizens. Some of the biggest gaps are~     higher cancer rates among African Americans. The purpose of this study is to find people who~     have increased inflammation and study how well a community-based dietary and physical~     activity program works at reducing the risk of African Americans developing~     inflammation-related diseases.~   "
138006|NCT01760889|"~     The primary purpose of this study is to determine whether SPD489 low dose range (40, 80, or~     100mg) and high dose range (120, 140, or 160mg) are effective in the treatment of Negative~     Symptoms.~   "
137990|NCT01761097|"~     Colorectal cancer is the second leading cause of cancer deaths in the UK(1) . Detection of~     cancer at an early stage, as well as detection and removal of polyps through gold standard~     colonoscopy examination decreases mortality from the disease. However colonoscopy has a well~     documented miss rate, with some areas of the bowel difficult to visualise and neoplastic~     lesions potentially hidden behind folds in the colon.~      The Endocuff© is a disposable polymer sleeve with hinged lateral arms. The arms flatten~     mucosal folds and fix the colonoscope centrally in the bowel lumen allowing controlled~     withdrawal and improving mucosal visualization. The cap easily attaches to the tip of current~     colonoscopes without modification. In this single centre, randomised controlled trial, the~     investigators aim to assess the performance of the current gold standard colonoscopic~     examination against the current gold standard colonoscopic examination with the Endocuff©~     attached to the colonoscope.~      The investigators aim to recruit 300 patients (150 in each group) who have previously been~     identified to have colonic polyps or cancers undergoing surveillance colonoscopy following~     NICE guidelines(2). Colonoscopy will be performed by Joint Advisory Group on~     gastro-intestinal endoscopy (JAG) certified colonoscopists following quality indicator~     guidance. All patients undertaking follow up surveillance colonoscopy for previous polyps or~     cancer will be invited to participate and those agreeing will be randomly allocated to one or~     other technique.~   "
137991|NCT01761084|"~     The long-term goal of our research team is to conduct a large multicentre study to evaluate~     whether tailored home exercise can prevent fractures in high-risk individuals. The proposed~     project will address the feasibility of such a trial, but will also evaluate the effect of~     exercise on quality of life, posture and many other outcomes important to individuals with~     vertebral fractures. Physiotherapists will conduct 6 home visits with participants to deliver~     the intervention (or social visit for controls) using a similar model to previous work by our~     team and others. The purpose of this pilot study is determining the feasibility of~     recruitment, retention and adherence of an international multicentre randomized controlled~     study evaluating the efficacy of thrice-weekly home exercise for one year among women with~     vertebral fracture. As secondary objectives, the investigators will examine the effects of~     exercise on function, balance, quality of life, pain, falls and fractures. The primary~     hypothesis is that the investigators will successfully recruit and retain the target sample,~     and achieve an adherence rate of 60%.~   "
137992|NCT01761071|"~     The investigators performed this study to investigate pain prevention of preoperative topical~     nonsteroidal anti-inflammatory drug (NSAID) in photorefractive keratectomy(PRK) using time~     serial pain scoring.~   "
137993|NCT01761058|"~     The overall goal of this proposal is to better understand the basis of airway remodeling in~     severe asthma and how remodeling changes overtime. The investigators propose to study a well~     characterized cohort of individuals with severe asthma using a multidisciplinary~     state-of-the-art-approach.~   "
137994|NCT01761045|"~     The objective of this study is to confirm that Monosodium L-Glutamate (MSG) supplementation,~     both alone or in combination with Nucleic Acid (IMP), enhances satiety and decreases food~     intakes at the next meal in healthy female adults.~   "
137995|NCT01761032|"~     In the proposed study, the investigators will assess the brain's dopamine response to UVR~     light in individuals who use tanning beds both frequently and infrequently.~   "
137996|NCT01761019|"~     Oral therapies for psoriasis, including methotrexate and acitretin, are often less effective~     when used as monotherapy (without other oral medicines or creams) than are newer biologic~     injected drugs. However, these oral medications are also less expensive than biologic agents~     and may be safer for use in some patients. The purpose of this study is to determine if~     adding a topical psoriasis medicine, calcipotriene/betamethasone topical suspension (Taclonex~     topical suspension), will improve the severity of psoriasis in patients already on~     methotrexate or acitretin and to determine if adding this topical suspension will reduce the~     desire of such patients to switch to a biologic agent to treat their psoriasis.~   "
137997|NCT01761006|"~     The purpose of this research study is to determine whether exhaled nitric oxide (FeNO) goes~     up during an acute exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD) and whether~     the level of exhaled nitric oxide returns to normal in the weeks after an exacerbation.~   "
137998|NCT01760993|"~     The primary purpose of this study is to determine if the long-term use of SPD489 (40, 80,~     100, 120, 140, and 160mg) administered as a daily morning is safe and tolerable.~   "
137999|NCT01760980|"~     The objective of this study is to assess the bioequivalence of the test product, Exemestane~     25 mg tablets of Actavis Group PTC ehf. Iceland, and the reference product, Aromasin®~     (exemestane) 25 mg tablets of Pharmacia & Upjohn Company, Division of Pfizer Inc., New York,~     United States of America in healthy male and postmenopausal female subjects, under fasting~     conditions~   "
138000|NCT01760967|"~     Background:~      Dexmedetomidine, a highly selective arfa2-adrenergic agonist, is known to be a unique~     sedative agent which causes less acute tolerance, drug addiction and withdrawal compared with~     gamma-aminobutyrate (GABA) agonists. Dexmedetomidine was approved for short-term ICU sedation~     in 2004 in Japan, and it has been used particularly for surgical ICU patients. In August 2010~     dexmedetomidine was approved in Japan for sedation lasting more than 24 hours.~      Recent evidence demonstrated that dexmedetomidine has organ protective effects including~     neuroprotection, cardioprotection, renal protection, gastrointestinal tract action, and~     anti-inflammatory action. Dexmedetomidine was shown to significantly decrease the infarct~     size in isolated rat hearts. Additionally, dexmedetomidine exhibited a preconditioning effect~     against ischemic injury in hippocampal slices, and this result was considered an apoptosis~     suppression effect of dexmedetomidine. Aydin C et al reported that dexmedetomidine enhanced~     the spontaneous contractions of the ileum in peritonitis rats compared with propofol and~     midazolam. Taniguchi and colleagues demonstrated that dexmedetomidine reduced high mortality~     rates and the plasma cytokine concentrations, interleukin-6 and tumor necrosis factor alpha~     in endotoxemic rats.~      A meta-analysis has shown that perioperative alfa2-adrenergic agonists, including~     dexmedetomidine infusion, decreased cardiovascular events on patients undergoing cardiac~     surgery. Dexmedetomidine treated patients undergoing thoracotomy indicated increase in urine~     output, reduction in serum creatinine, and the suppression of diuretics in a randomized~     placebo-controlled double-blind study. Septic patients receiving dexmedetomidine had improved~     28-day mortality rates compared with septic patients receiving lorazepam in a sub-group~     analysis of MENDS randomized controlled trial.~      These positive effects of dexmedetomidine on the cardiovascular system, neurons, kidneys,~     gastrointestinal tract action, and an anti-inflammatory action, are expected to improve~     mortality in septic patients. However, large clinical research studies have not been~     conducted yet. We designed and conducted the DESIRE trial (DExmedetomidine for Sepsis in ICU~     Randomized Evaluation trial) to test a hypothesis that dexmedetomidine may improve clinical~     outcome and has these organ protective effects on septic patients.~      Objective:~      To determine whether dexmedetomidine improves clinical outcome and has organ protective~     effects on septic patients.~   "
138001|NCT01760954|"~     A randomized study evaluating the continued safety and efficacy of elagolix in the management~     of moderate to severe endometriosis-associated pain in adult pre-menopausal female subjects~     who completed the 6 month treatment period in the pivotal study M12-665.~   "
138007|NCT01760876|"~     Since polymers have been identified as a possible cause of late complications of drug eluting~     stents, new stents are being designed to improve polymers' biocompatibility or to bond drugs~     on stents without polymers.~      Biolimus A9 is the therapeutic agent used in the BioFreedom drug coated stent. Biolimus A9 is~     a proprietary semi-synthetic sirolimus derivative. It is highly lipophilic, rapidly absorbed~     in tissues, and able to reversibly inhibit growth factor-stimulated cell proliferation.~      In this study, we use intracoronary optical coherence tomography (OCT) to evaluate the~     BioFreedom Stents after implantation regarding endovascular healing over time as primary~     objective; and also to evaluate secondary OCT, angiographic and clinical outcomes at various~     specific time points.~   "
138008|NCT01760863|"~     The primary purpose of this study is to compare the re-infection rates in patients undergoing~     2-stage revision arthroplasty who receive additional oral antibiotic therapy to those~     patients who received in-hospital perioperative antibiotic only. Patients will be monitored~     for re-infection following hospital discharge, defined as deep infection of the joint~     space/capsule that requires return to the operating room within 24-months of the~     re-implantation procedure.~   "
138009|NCT01760850|"~     This pilot clinical trial studies a breast and cervical cancer educational intervention for~     Latinas in Western New York. An outreach program may help minority cancer patients overcome~     problems that keep them from receiving cancer screening.~   "
138010|NCT01760837|"~     Based on the current knowledge, the investigators hypothesized that most children with milk~     allergy in Israel would be able to ingest baked milk products daily, thus benefiting from~     improved nutrition and dietary variety and protect them from accidental exposure to~     milk-containing products.~      Objective: The aim of our study is to examine the outcome of cow's milk allergic patients who~     incorporated baked milk products into their diets. In order to recruit a large population, a~     multicenter study across many hospital related allergy clinics in Israel will be conducted.~      Methods~      Participants The study protocol is essentially as described previously (12). Subjects will be~     recruited from the relevant allergy clinics involved in this project. The study will be~     approved by the local Institutional Review Board, and informed consent will be obtained.~      Eligible subjects will be aged 1 to 18 years, had positive skin prick test (SPT) responses or~     detectable serum milk-specific IgE, and had a history of an allergic reaction to milk within~     6 months before study entry or milk-specific IgE levels or SPT responses greater than 95% of~     predicted value for clinical reactivity (if <2 years old, a level >5 kUA/L; if >2 years old,~     a level >15 kUA/L; SPT mean wheal diameter, >8 mm.~      Exclusion criteria include a negative SPT response and an undetectable milk-specific IgE~     level; a history of anaphylaxis requiring intensive care unit hospitalization; unstable~     asthma or a history of intubation related to asthma; previously diagnosed milk-induced~     eosinophilic gastroenteropathy; a recent reaction (within 6 months) to a baked milk product;~     or pregnancy.~      Design~      Active group - Based on the results of the initial baked milk oral challenge, subjects will~     be categorized as baked milk reactive or baked milk tolerant (group I and II, respectively).~     Group I subjects will be instructed to completely avoid all forms of milk but will be offered~     a repeat challenge 6 or more months from the initial challenge. Group II subjects will be~     instructed to incorporate baked milk products daily into their diets and after 6 or more~     months will be offered challenges to baked cheese products (pizza). Similarly, after 6 or~     more months, baked cheese-tolerant children will be offered challenges to unheated milk.~      The two groups will be followed at least 2 years and the outcome as well as other parameters~     (accidental exposure, use of medication, quality of life, appearance of related symptoms,~     ect) will be compared between the 2 groups.~      Baked milk - Each muffin (or the equivalent piece of cake) contains ~ 1.3 g of milk protein.~     The muffins/cake will be prepared according to instructed recipe and will be baked at 180~     degree C for 30 minutes. Baked milk-tolerant subjects will be instructed to ingest 1 to 3~     servings per day of store-bought baked milk products with milk listed as a minor ingredient~     (third or less) or home-baked products with an equivalent amount of milk protein.~      Baked cheese - Cheese pizza (Maadanot), will be baked at 2200 C for 13 minutes or longer.~     Baked cheese-tolerant subjects will be instructed to eat any brand of well-cooked cheese~     pizza 4 to 7 times weekly and limited to 1 daily serving.~      Unheated milk - Challenges will be performed with skim milk totaling 240 mL (or other product~     containing 8-10 g of unheated milk protein, such as yogurt).~      Follow-up allergy evaluations - Blood and serum samples will be collected for the measurement~     of IgE and IgG4 antibodies to milk, casein, and b-lactoglobulin by using UniCAP (Phadia,~     Uppsala, Sweden) as well as for T cell analyses. (This part is optional upon agreement of the~     parents).~      Un-blinded food challenges will be performed under a physician's supervision in the clinical~     research unit. Muffin and pizza will be administered in 4 equal portions over 1 hour.~     Unheated milk will be administered in gradually increasing doses. Subjects will be monitored~     throughout and for 2 to 4 hours after completion of the challenge. Challenges will be~     discontinued at the first objective sign of a reaction or due to convincing persistent~     subjective symptoms, and appropriate treatment will be initiated immediately.~   "
138011|NCT01760824|"~     Helicobacter pylori (HP), a bacterium present in many people's stomachs, is one of the major~     causes of ulcers and cancers. Up to 20% of patients infected with H. pylori may develop~     peptic ulcers. However, failure rate is rising due to multiple resistant H. pylori infection.~     The eradication rate of first line clarithromycin based therapy has fallen to below 80%. Both~     quadruple and sequential treatment regime has been proposed as the first-line empirical~     regime. Nevertheless, comparison in terms of efficacy and side effects between the two regime~     remained unknown. The aim of this clinical trial is to compare the efficacy and tolerability~     of H. pylori eradication with a 10-day quadruple therapy versus sequential therapy as~     empirical first and second line treatment.~   "
138012|NCT01760811|"~     To compare the Disease free survival (DFS) rate of a preoperative cetuximab treatment~     followed by operation and postoperative radiation-cisplatin-cetuximab treatment paradigm for~     advanced oral cavity cancer, , with the DFS rate of historical controls (from the RTOG 9501~     and EORTC 22931 studies in which treatment was with surgery followed by radiotherapy and~     cisplatin) with a similar stage of the disease.~   "
138013|NCT01760798|"~     Osteoporosis is characterized by decreased bone strength and it is prevalent among~     postmenopausal women but also occurs in men and women with underlying conditions or major~     risk factors associated with bone demineralization. Its chief clinical manifestations are~     vertebral and hip fractures, although fractures can occur at any skeletal site.The World~     Health Organization (WHO) operationally defines osteoporosis as a bone density that falls 2.5~     standard deviations (SD) below the mean for young healthy adults of the same gender—also~     referred to as T-score of -2.5. Postmenopausal women who fall at the lower end of the young~     normal range (a T-score of >1 SD below the mean) are defined as having low bone density~     (osteopenia) and are also at increased risk of osteoporosis. More than 50% of the fractures,~     including hip fractures, among postmenopausal women occur in this group.~      Teriparatide is one of the most effective treatment options for osteoporosis. But the cost of~     teriparatide is prohibitively expensive and in countries like India with limited personal~     resources of the individuals, its not a feasible option in the majority of the patients with~     severe osteoporosis. The investigators aim to compare weekly versus daily teriparatide~     therapy in an open label non inferiority trial and if successful, the investigators~     anticipate, the cost of treatment could be reduced considerably so that treatment becomes~     more affordable to a larger number of patients. Also with weekly therapy, number of multiple~     injections could be brought down.~   "
138014|NCT01760785|"~     Successful treatment of traumatic brain injury (TBI)-induced mood lability may reduce or~     eliminate drinking behaviors in persons with alcohol abuse/dependence (AA/D) and affective~     lability following TBI. Observed clinically, the symptoms of poorly regulated affective~     expression of AA/D+TBI patients who reach alcohol abstinence do not appear to be those of an~     idiopathic mood or anxiety disorder. These symptoms do not present the severity or the same~     natural courses as do Major Depressive Disorder, Bipolar Illness, or Anxiety Disorder, for~     example. Instead, both symptoms and course appear more characteristic of the sustained affect~     lability often observed following TBI. This observation suggests that TBI survivors represent~     a patient group for whom treatment of neuropsychiatric symptoms following TBI may alleviate~     both TBI-related affect lability and also heavy ethanol use by treating the condition that is~     contextually related to excessive alcohol use.~      Based on this concept of consequently treating AA/D through the management of post-TBI~     affective lability, this study was conducted observing the efficacy of divalproex sodium on~     the severity of affective lability and AA/D in persons suffering from a moderate TBI.~     Divalproex sodium has been shown to ameliorate mood disorders, even in those with substance~     abuse problems. This drug has also shown positive results as an alternate medication to~     benzodiazapines in the treatment of alcohol withdrawal, significantly reducing the~     progression of withdrawal symptoms in patients.~   "
138015|NCT01760772|"~     Individuals with obesity have an increased risk for heart disease and diabetes. There are~     current drugs on the market that target the hormone, Glucagon like peptide-1 (GLP-1) to treat~     diabetes. The investigators want to determine if targeting this hormone will also help people~     with high cholesterol and triglycerides. In this study, the investigators are looking at the~     role of GLP-1 in healthy subjects and subjects that have had bariatric surgery.~   "
138025|NCT01760642|"~     Identification and evaluation of endogenous markers for the assessment of CYP3A activity in~     female subjects using metabolomics~   "
138040|NCT01760447|"~     The purpose of this study is to assess the safety and efficacy of the addition of sitagliptin~     (administered as MK-0431A XR) compared with the addition of placebo to therapy with~     extended-release metformin (metformin XR) for the treatment of type 2 diabetes mellitus~     (T2DM) in pediatric participants with inadequate glycemic control on metformin therapy (alone~     or in combination with insulin). The primary hypothesis is that the addition of sitagliptin~     reduces hemoglobin A1c (A1C) more than the addition of placebo after 20 weeks of treatment.~   "
138016|NCT01760759|"~     In this study, investigators propose to randomize 165 human immunodeficiency virus positive~     patients to one of three 16-week treatment conditions: (1) standard care; (2) standard care +~     cell phone-based adherence reminders; or (3) standard care + cell phone-based adherence~     reminders and contingency management. In this latter condition, patients will earn~     reinforcement for sending in time- and date-stamped self videos of antiretroviral therapy~     medication ingestion. Primary outcomes will include viral loads and self-report measures of~     adherence, and effects will be evaluated both during the treatment period and throughout a~     one-year follow-up. Investigators hypothesize that the cell phone reminder condition will~     improve adherence relative to standard care, and the cell phone reminder plus contingency~     management condition will have the best outcomes. Results from this study may have widespread~     implications for the use of cell phones as a novel technology to improve initial adherence to~     antiretroviral therapy, thereby reducing the spread of drug resistant human immunodeficiency~     virus strains to the community.~   "
138017|NCT01760746|"~     PDR is a leading cause of irreversible vision loss in North America. This disease is caused~     by the growth of abnormal blood vessels in the retina. These abnormal blood vessels can bleed~     inside the eye, causing a vitreous hemorrhage (VH). Sometimes when patients have this~     bleeding, a surgery called vitrectomy is required to remove the blood from within the eye. In~     order to reduce complications during the surgery, most retina surgeons will inject Avastin~     into the eye a few days before the surgery.~      Avastin (bevacizumab) is currently not approved by Health Canada to treat any ocular disease.~     Lucentis (ranibizumab) is approved by Health Canada as a treatment for age-related macular~     degeneration, diabetic macular edema, and retinal venous occlusive disease. While Avastin is~     not approved by Health Canada for the treatment of these diseases, the majority of retina~     specialists around the world are now using Avastin off-label to treat these diseases. That~     is because Avastin and Lucentis both tend to work equally well in these disease, but Avastin~     is significantly cheaper. While Avastin and Lucentis are generally regarded to be equal,~     there may be some differences between these two drugs that have not been discovered. The aim~     of this study is to look for these differences.~      Previous research by the investigators in this study has shown that injecting Avastin into~     eyes causes increased inflammatory proteins to develop inside the eye. This increase in these~     proteins was related to complications that developed after the vitrectomy surgery. Lucentis~     may be associated with less of an increase in inflammatory proteins (and less complications).~     The aim of this study will be to compare Avastin and Lucentis with respect to how they affect~     inflammatory proteins in the eye, as well as the rate of complications during surgery.~      Study participants will be divided into two arms (groups) of 30 subjects. Subjects will~     receive Avastin or Lucentis a few days before vitrectomy surgery. The assignment will be~     random and the study is double-masked. Masking is done so that the investigators can clearly~     determine any differences between the 2 drugs.~   "
138018|NCT01760733|"~     Kidney transplantation has been shown to provide improved survival even in patients older~     than 70 years of age. The purpose of the study is to determine whether kidney transplantation~     provides any improvement of health related quality of life (HRQOL) in patients over the age~     of 65 years. HRQOL wil be monitored using the Kidney Disease and Quality of Life~     (KDQOL-SF)form. Patients will be recruited at the time of acceptance to the Norwegian~     transplant wait list and followed every 6 months until transplantation. Thereafter a new form~     will be completed after 10 weeks postv transplant, 6 months, 1 year, 3 years and 5 years. In~     addition the study will explore the transplant candidates expectations in a qualitative study~     design and explore the relationship between pre-transplant comorbidity, HRQOL and survival.~   "
138019|NCT01760720|"~     Based on our previous success with the intervention pilot (R34MH083512), we conducted this~     randomized controlled trial (MMT CARE), which will integrate behavioral intervention~     components with a primarily pharmacological model of MMT. The intervention focuses on~     treatment adherence and effective outcomes by reducing stigmatizing attitudes and behaviors~     among service providers, enhancing their communication skills, and improving their~     interactions with and support of their clients' behavior changes. Our goal is to bring a~     contextual change to support a protective environment for clients' motivation and capacity in~     order to reduce their HIV risk. The findings could benefit not only China but also the global~     community by effectively combining interventions for controlling the HIV epidemic.~   "
138020|NCT01760707|"~     The purpose of the study was to investigate the effects of training on the exercise~     capability, balance performance, and microcirculation. Furthermore, to search the possible~     underlying mechanisms.~   "
138021|NCT01760694|"~     To assess the ability of a combination of updated and approved modalities in the treatment of~     first line pancreatic cancer patients to increase the time to Progression Free Survival~   "
138022|NCT01760681|"~     The purpose of the study is to explore the efficacy and safety of H-Coil rTMS in comparison~     to a sham H-Coil rTMS in older patients with treatment-resistant major depressive~     disorder.Subjects will be randomized to receive H1-Coil rTMS or sham H1-Coil rTMS. The acute~     treatment phase will last four weeks. Treatment is administered daily, 5 days per week (i.e.,~     20 treatments). Depressive symptoms will be assessed using the HDRS-24. If subjects achieve~     the pre-defined primary outcome criteria of remission (HDRS-24 score < 10 and 60% reduction~     in symptoms) they will continue with twice weekly treatment for two more weeks to ensure the~     durability of the remission. Subjects who do not achieve remission will exit the study after~     the acute treatment phase of four weeks. The blind will not be broken to subjects until the~     completion of the study~   "
138023|NCT01760668|"~     The study aim is:~        1. To examine aortic tissue by light microscopy~        2. To examine aortic tissue by electron microscopy~        3. To study changes in the epigenome and transcriptome of the X chromosome specific to~          aortic tissue.~        4. To examine aortic tissue using biochemistry including proteomics.~        5. To establish the karyotype of fibroblasts with standard chromosome examination on 10~          meta-phases as well as by fluorescent in situ hybridization (FISH) with probes covering~          the X and Y chromosome. Using the latter 200 meta-phases will be examined.~      30 controls who did not die from aortic dissection or dilation will be recruited from The~     Department of Forensic Medicine at Aarhus University Hospital.~      The investigators will subject samples of aortic tissue from women undergoing prophylactic~     aortic surgery due to either Marfan syndrome or bicuspid aortic valve to the same panel of~     examinations (except karyotyping). Lastly the investigators will compare the results from the~     three groups (Turner syndrome, Marfan syndrome and Bicuspid aortic valve).~   "
138024|NCT01760655|"~     This clinical trial studies reduced-intensity conditioning before donor stem cell transplant~     in treating patients with high-risk hematologic malignancies. Giving low-doses of~     chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the~     growth of cancer cells. It may also stop the patient's immune system from rejecting the~     donor's stem cells. The donated stem cells may replace the patient's immune cells and help~     destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the~     donor's T cells (donor lymphocyte infusion) after the transplant may help increase this~     effect.~   "
138026|NCT01760629|"~     Whole body cooling improves survival with normal neurological outcome after neonatal~     encephalopathy in high-income countries. However, cooling equipments used in the high-income~     countries are expensive and unsuitable for wider use in low and middle-income countries~     (LMIC). We had previously conducted a randomised controlled trial of whole body cooling using~     phase changing material in south India. Although cooling was provided, there were wide~     temperature fluctuations.~      Aim: To examine efficacy of the low technology cooling equipment (Tecotherm-HELIX) in~     administering effective and stable whole body cooling in encephalopathic infants.~      Methods: After informed parental consent (and ethical approvals), we will administer 72 hours~     of whole body cooling (rectal temperature 33 to 34C) to a total 50 encephalopathic infants~     (aged <6 hours) admitted to the neonatal units at Calicut Medical College and Madras Medical~     College, over a six month period. To induce cooling, the infants will be kept on the cooling~     mattress. Temperature will be continuously measured for 80 hours using a rectal probe~     connected to a digital data logger.~      The primary outcome will be the effective cooling time i.e. percentage of time (95% CI) for~     which the temperature remains between 33 to 340C during the intended cooling period.~   "
138027|NCT01760616|"~     To evaluate the efficacy and safety of Huaier Granule for prevention of disease progression~     of hepatocarcinoma after non-radical hepatectomy.~   "
138028|NCT01760603|"~     Pelvic organ prolapse is a common problem. The primary treatment is surgery. Ischia spinous~     fascia fixation procedure is developed in China for vaginal apex fixation with native tissue.~      This study is designed to determine the effectiveness and safety of ischia spinous fascia~     fixation procedure for the treatment of pelvic organ prolapse stage III.~      Patients enrolled into the study will be followed up for up to 3 years after surgery.~     Evaluation will take place during surgery and postoperative visit. Stage of prolapse before~     and after surgery, patient satisfaction through quality of life and sexual function~     questionnaires before and after surgery, and peri-operative complication rates will be~     evaluated.~   "
138029|NCT01760590|"~     The purpose of this research is to compare the effects of two commonly used, safe, thoracic~     spine grade 1-4 and grade 5 mobilization to the thoracic spine on cervical spine pain in~     individuals with nontraumatic cervical pain. The immediate effects of thoracic spine~     mobilization have been shown to facilitate greater range of motion increases in the cervical~     spine and greater pain decreases within a treatment session and on follow-up visits. There is~     no research utilizing pain threshold perception as an objective outcome of these treatments.~     Only one study compared the two treatment techniques and concluded that future research~     should be completed which includes manual therapy for the thoracic spine. (Cleland 2007)~   "
138030|NCT01760577|"~     The purpose of this study is to compare the effects of intraarticular Botulinum Toxin A~     versus intraarticular hyaluronate plus rehabilitation exercise in patients with ankle~     osteoarthritis.~   "
138031|NCT01760564|"~     To evaluate the changes in cognitive function after miglustat treatment in Niemann-Pick type~     C patients.~   "
138032|NCT01760551|"~     The American Medical Association's (AMA) Guides to the Evaluation of Permanent Impairment is~     used to rate loss of function and determine compensation and ability to work after injury or~     illness. The AMA Guides are used by many different systems to determine compensable levels of~     impairment. However, there are few studies that evaluate reliability or construct validity.~     (1) In the professional community there exists considerable controversy regarding the~     accuracy and usefulness of the AMA Guides. (2,3) Commentaries have noted that the AMA Guides~     do not provide a valid, reliable, evidence-based system for the rating of impairments. (4)~     Some have argued that the impairment ratings do not reflect an individual's actual loss of~     function and quality of life (QOL). The AMA guides 5th edition was based on loss of range of~     motion (ROM). The new 6th edition of the AMA guides is based on diagnosis and inclusion of~     functional outcomes assessments in the determination of impairment ratings. (5) In the~     orthopaedic literature the use of patient-derived, objective outcome measures has~     substantially expanded QOL instruments are categorized as general health or as~     condition-specific questionnaires. The Medical Outcomes Study 36-Item Short Form (SF-36) is a~     general health-based survey of quality of life. It has been validated and is used widely~     across medical disciplines. (6) The SF-36 was constructed to survey health status in the~     Medical Outcomes Study. It was designed for use in clinical practice and research, health~     policy evaluations, and general population surveys. The SF-36 was constructed for~     self-administration by persons 14 years of age and older, and for administration by a trained~     interviewer in person or by telephone. (7) The SF-36 is perhaps the most widely used~     health-related quality of life (HRQoL) survey instrument in the world today. It is comprised~     of 36 items that assess eight health concepts: physical functioning, role limitations caused~     by physical health problems, role limitations caused by emotional problems, social~     functioning, emotional well-being, energy/fatigue, pain, and general health perceptions.~     Physical and mental health summary scores are also derived from the eight RAND-36 scales. (8)~     The aim of this study is to determine the amount of correlation between the by orthopaedic~     surgeon objectively calculated percentage of impairment scored by the American Medical~     Association guides to the evaluation of permanent impairment and the by patient subjectively~     indicated health-related quality of life scored by the SF-36.~      Hypotheses: Because of and inclusion of functional outcomes assessments in the determination~     of impairment ratings the AMA guide 6th edition will have a better correlation with the~     SF-36. The 6th edition of the AMA guide is based on diagnosis en yield lower impairment~     percentages than the AMA guide 5th edition that is based on loss of ROM. The SF-36 will have~     better correlation with the impairment ratings for lower extremities injuries than for upper~     extremities because it is less valid for the upper extremities.~   "
138033|NCT01760538|"~     The purpose of the study was to investigate the changes on heart rate variability, exercise~     capacity, activities of daily living, and quality of life after aerobic exercise training in~     cardiac transplant recipients.~   "
138034|NCT01760525|"~     This is a first in human phase I study of single agent CGM097 in patients with advanced solid~     tumors who have progressed despite standard therapy or for whom no standard therapy exists.~     The tumor must be characterized by p53wt status. The study consists of a dose escalation part~     where patients will receive escalating doses of CGM097, and a dose expansion part in which~     patients are given CGM097 at the maximum tolerated dose (MTD) or Recommended Phase 2 Dose~     (RP2D). Each dose escalation step will be decided based on the recommendation from an~     adaptive Bayesian logistic regression model (BLRM).~   "
138035|NCT01760512|"~     The purpose of this study is to gather clinical and economic evidence on the use of robotics~     for bariatric surgery (gastric bypass).~      This monocentric, randomized, single blind, controlled study will evaluate post-operative~     pain, quality of life and appetite, post-operative complication incidence. It will also~     provide information on direct and indirect costs of surgery.~   "
138036|NCT01760499|"~     The main purpose of this study is to find out more about how PV-10 works in melanoma tumors.~     Researchers also want to find out if there are changes in the body's immune cells (cells that~     fight infection and illnesses) after PV-10 is given, both inside the melanoma tumors and~     circulating in the blood.~   "
138037|NCT01760486|"~     The investigators have shown that adding an internet behavioral weight loss program to a~     statewide campaign improves weight loss outcomes. However, our follow-up data suggest that~     once the intervention is stopped, participants begin to experience weight regain. Thus, the~     purpose of this project is extend this line of work and pilot test health coaches and~     monetary incentives for weight loss maintenance. The investigators hypothesize that coaching~     and incentives will improve longer-term weight outcomes.~   "
138042|NCT01760421|"~     Hashimoto's thyroiditis is an autoimmune thyroid disease, which induced chronic inflammation~     of thyroid gland and destroys thyroid tissue.~      Hydroxychloroquine is used as disease modifying anti-rheumatic drug (DMARD) for treatment of~     several autoimmune diseases, such as systemic lupus erythematosus (SLE), rheumatoid~     arthritis(RA) for more than one century.~      The purpose of this study is to evaluate whether hydroxychloroquine is effective in treatment~     of Hashimoto's thyroiditis.~   "
138043|NCT01760408|"~     The American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) developed a Web-based~     registry for nutrition care launched in early 2011, initially focusing on the home parenteral~     nutrition (HPN) patient population. The purpose of Sustain is to collect information~     regarding the patients and populations who require HPN in the United States, measure outcomes~     associated with HPN, allow institutional benchmarking against the aggregate data, and publish~     the findings to improve the quality of care for patients receiving HPN. The registry is open~     to all sites (hospital and home based) who care for new or existing HPN patients.~   "
138044|NCT01760395|"~     Inguinal hernia repair is the most common procedure in general surgery. Even with acceptable~     complication rates, thousands of patients worldwide suffer from inguinal hernia surgery~     complications every year. In Finland, the Finnish Patient Insurance Centre (FPIC) receives~     reports from surgical complications. In this study, the database of FPIC is used to compare~     the complication profiles of open and laparoscopic inguinal hernia surgery with mesh.~   "
138045|NCT01760382|"~     Myocardial infarction (MI) outcomes strictly depend on the time to reponed the~     infarct-related coronary artery. Networks have been activated in the last years in many~     countries to achieve fast track access of patients with ST-elevation MI to hospital with h24~     primary PCI availability or directly to Cath Labs. From 2011 a regional STEMI network have~     been formally activated in Piedmont. The aim of our registry is to monitor the activity of~     the STEMI network in the large suburban area of Novara (population of about 800.000~     subjects).~   "
138046|NCT01760369|"~     The purpose of this study is to determine whether head rotation in prone positon affects~     regional cerebral oxygenation (rSO2)in anesthetized patients undergoing lower back surgery.~   "
138047|NCT01760356|"~     To search for suitable pharmacodynamic biomarkers, i.e., with high specificity for~     calcineurin inhibition and most affected by inter-individual variability, our works aimed at~     exploring the pharmacodynamics of CNI, the strength and variability of signal translation~     along the calcineurin pathway, as well as the steps where sources of internal (genetic) or~     external variability are the most influential.~      In order to achieve this, we assessed simultaneously NFAT1 translocation into the nucleus of~     peripheral blood mononuclear cells (PBMC) (NFTA1 being the main NAFT isoform in resting and~     activated lymphocytes), the intracellular expression of IL-2 in CD3+, CD4+ and CD8+ T cell~     subsets and the membrane expression of CD25 (IL-2Rα), a surface marker of T cells activation,~     in T cells at large. A non-interventional clinical trial was set up in healthy volunteers,~     patients registered on a liver transplantation waiting list (WLP) and liver transplant~     recipients (LTR). A different question was addressed in each group: The healthy volunteer~     study (n=35): explored TAC PD along the calcineurin pathway by exposing PBMC ex-vivo;~     modelled signal translation along this cascade; examined the interindividual variability of~     TAC PD parameters; and investigated the sources of the variability observed and their~     contribution at each step of the calcineurin pathway. Furthermore, it allowed us to evaluate~     the analytical variability of our techniques as well as the intra-individual variability of~     TAC PD parameters. WLP (n=19) were enrolled to confirm in patients with liver diseases the~     results obtained in healthy volunteers, as well as to test the potential influence of their~     initial disease on the ex-vivo pharmacodynamics of TAC. The aims of the transversal study of~     LTR on CNI (n=80) were to further explore the interindividual variability in the PD of CNI in~     realistic clinical conditions, i.e. in situations of residual PD activities under tacrolimus~     or cyclosporine exposure, and the potential pharmacogenetic (PG) sources of such variability.~     The (still small) group of liver transplant patients (n=9) enrolled immediately before~     transplantation and followed-up with serial monitoring along the first year~     post-transplantation was intended to explore the relationships between CNI PD and clinical~     responses.~   "
138048|NCT01760343|"~     A new formulation of Berinert (CSL830) is being investigated for the management of hereditary~     angioedema (HAE). The main aim of the study is to assess the safety of a single 1500 IU dose~     of the new formulation of Berinert. This study will also look at the pharmacokinetics of~     CSL830 relative to Berinert currently on the market.~   "
138049|NCT01760330|"~     This project is being used to assess the utility of intravenous acetaminophen in the~     pediatric population undergoing palate repairs. This study is a prospective randomized double~     blinded placebo controlled study. The investigators will have two arms, one group of patients~     will receive intravenous acetaminophen and one group that will receive a placebo at a total~     of four doses over 24 hours. The results of this study may affect the intraoperative~     anesthetic management as well as post-operative surgical management of this specific patient~     population. The goal is to determine the benefit of adding a non-opioid analgesic and~     hypothesizing that it may reduce the amount of narcotic consumption in the post anesthesia~     care unit as well as during the post-operative stay.~   "
138050|NCT01760317|"~     The purpose of this study is to compare two different approaches (midline and parasagittal)~     during interlaminar lumbar epidural steroid injection (LESI), and to verify the role of~     concordant pressure paresthesia occurring during the LESI in determining outcome.~      The investigators are planning to include 100 patients, undergoing LESI for radicular low~     back pain. This will be single-blinded randomized study. Every patient will receive the same~     medication we would use regardless of participating in the study. The patients will be~     randomly assigned to one of two groups, based on the approach:~        -  Group I (50 patients) - will get LESI using midline (MIL) approach.~        -  Group II (50 patients) - will get LESI using parasagittal interlaminar (PIL) approach.~   "
138051|NCT01760304|"~     To investigate whether Budesonide/Formoterol (Symbicort ®) therapy can improve heart function~     at rest by decreasing lung hyperinflation in patients with COPD (Chronic Obstructive~     Pulmonary Disease).~   "
138052|NCT01760291|"~     To provide additional information about the safety and efficacy of the WATCHMAN LAA Closure~     Technology~   "
138053|NCT01760278|"~     1. Culture conditions of developing embryos are highly controlled in the Embryoscope and~          are monitored by Time-lapse videography to produce 3D images at different stages.This~          cannot be done under conventional culture conditions.~        2. The 3D images thus produced,are analysed with the help of Embryoviewer, a part of the~          Embryoscope,through latest software.~        3. Embryoviewer also identifies embryos for transfer, freezing and to be discarded.~   "
138087|NCT01759836|"~     Biochemical recurrence develops in approximately 30-40% of men with locally advanced prostate~     cancer who undergo radical prostatectomy. To date, the effect of statins on prostate cancer~     recurrence has been investigated in several retrospective studies with inconsistent results.~     The purpose of this study is to determine the impact of statin on biochemical recurrence~     after radical prostatectomy for locally advanced prostate cancer.~   "
138054|NCT01760265|"~     Dysbetalipoproteinemia (type III, Fredrickson's classification) is a rare metabolic disorder.~     It results from a defect in the clearance of VLDL and chylomicron remnants due to homozygous~     APOE2 variants or heterozygous APOE mutations, and there is an elevated plasma cholesterol~     and triglycerides.~      As a consequence of the derangements in lipoprotein metabolism, dysbetalipoproteinemia~     predispose to the premature development of atherosclerosis.~      However among this population there is heterogeneity in development of cardiovascular~     complications and the determinants remain unclear actually.~      The aim of the investigators study is to evaluate the intensity of clinical atherosclerosis,~     and identify its determinants.~   "
138055|NCT01760252|"~     The combination of capecitabine, oxaliplatin, and irinotecan (CAPOXIRI) may be better than~     other combinations used to treat earlier stage pancreatic cancer patients with resectable~     (able to be cut out), borderline resectable, and locally advanced pancreatic adenocarcinoma.~     For subjects who can not obtain Capecitabine can be treated with 5-Fluorouracil (5-FU) along~     with Oxaliplatin and Irinotecan. Though all of the drugs in this study have been approved by~     the FDA, their combination is investigational. The purpose of this study is to evaluate the~     effects of CAPOXIRI (good and bad) on you and your cancer.~   "
138056|NCT01760239|"~     The goal of this project is to improve detection and management of elevated blood pressure in~     adolescents. It (a) uses electronic health record (EHR) technology to deliver~     patient-specific clinical decision support (CDS) to providers at the point of care, (b)~     assesses the impact of this intervention on identification and clinical care of hypertension~     in adolescents, and (c) assesses the impact of the intervention on costs of care.~   "
138057|NCT01760226|"~     The subject is invited to take part in this research study because s/he has been diagnosed~     with Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), or~     Post-transplant Lymphoproliferative Disorder (PTLD).~      In an attempt to improve cure rates while reducing harmful effects from drugs, oncologists~     are developing new treatment protocols. One such protocol, entitled dose-adjusted EPOCH-R,~     utilizes two major new strategies. First, the treatment approach utilizes continuous infusion~     of chemotherapy over four days, instead of being administered over minutes or hours.~     Secondly, the doses of some medications involved are increased or decreased based on how the~     drugs affect the subject's ability to produce blood cells, which is used as a measure of how~     rapidly the body is processing drugs.~      Using this approach in adults, researchers have shown improved cure rates in these cancers.~     Additionally, the harmful effects experienced by patients has been mild, with mucositis,~     severe infections, and tumor lysis syndrome occurring rarely. However, this new dosing method~     has never been used in children, and the effectiveness and side effects of this new method~     are unknown in children.~      The purpose of this study is to look at the safety of dose-adjusted EPOCH-R in the treatment~     of children with mature B-cell cancers, and to see if we can maintain cure rates (as has been~     shown in adults). This study represents the first trial of dose-adjusted EPOCH-R in children.~   "
138058|NCT01760213|"~     The goal of the project is to overcome some of the common barriers to treatment amongst~     recent survivors of traumatic events, by combining the world of evidence-based intervention~     with that of modern Internet technology. Specifically, it aims to test the feasibility and~     effectiveness of an Internet delivery of early-intervention trauma-focused cognitive~     behavioral therapy (CBT) for preventing post-traumatic stress disorder (PTSD). Over the~     course of the study the following objectives will be achieved:~        1. The development of an Internet-based Virtual Reality intervention for preventing PTSD~          among patients who have recently experienced a traumatic event.~        2. The evaluation of the feasibility of administering this intervention, and~        3. The evaluation of the efficacy of this Internet based intervention in the prevention of~          PTSD in recent trauma survivors.~   "
138059|NCT01760200|"~     Drug eluting balloons (DEB) have been developed to overcome the limitations of drug eluting~     stent (DES), but clinical results of different studies about DEB are not consistent.~      Thus, we planned a meta-analysis to compare outcomes of DEB and DES in coronary artery~     disease (CAD).~   "
138060|NCT01760187|"~     This is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) and~     multiple ascending dose (MAD) study of orally administered lomitapide in healthy male~     Japanese and Caucasian subjects with elevated LDL-C. The purpose for this study is to~     evaluate the PK and PD of lomitapide in Japanese subjects as compared to Caucasian subjects.~   "
138061|NCT01760174|"~     This study compares the effect on postoperative pain of bolus administration of ropivacaine~     in Transversus abdominis plane catheter and continuous bupivacain-infusion in epidural~     catheters following open gynecologic surgery.The study is double blind. The hypothesis is~     that the effect of the two modes of pain treatment are equal.~   "
138062|NCT01760161|"~     To evaluate the effects of bilateral dual transversus abdominis plane block on postoperative~     pain after robotic assited laparoskopic surgery and measure the plasma-level of ropivacain~     after the bilateral dual transversus abdominis plane block.~   "
138063|NCT01760148|"~     The purpose of this study is to validate the first round HCV early dynamics discovery within~     a larger population.~   "
138064|NCT01760135|"~     After severe trauma, high caloric nutrition supplement do harm on metabolic and immunologic~     aspects.~   "
138065|NCT01760122|"~     This study is aimed to assess the efficacy and safety of Peginterferon alfa-2b (40kD,~     Y-shape), in a dose of 180μg/week, in chronic hepatitis B patients, and collects sufficient~     evidences for the listed of the studied drug.~   "
138066|NCT01760109|"~     In the proposed study, the investigators plan to evaluate the efficacy and safety of~     Piperacillin Sodium and Sulbactam Sodium for Injection(2:1) for the treatment of respiratory~     and urinary tract acute bacterial infection.~   "
138067|NCT01760096|"~     Paroxysmal nocturnal hemoglobinuria is an acquired chronic hemolytic anemia,this study is~     designed to evaluate the safety and efficacy of Levamisole combined with cyclosporine A in~     patients with Subclinical Paroxysmal Nocturnal Hemoglobinuria and PNH in the setting of~     another bone marrow failure syndromes~   "
138088|NCT01759823|"~     The purpose of this study is to improve the blood glucose level in type 2 diabetic patients.~   "
138142|NCT01759121|"~     This randomized, parallel controlled, clinical-trial aims to evaluate the therapeutic~     efficacy of 532nm laser partially subthreshold panretinal photocoagulation with PASCAL~     endpoint management function for severe non-proliferative diabetic retinopathy.~   "
138068|NCT01760083|"~     CTOs are common among patients with angina, and are detected in around 20% of patients~     undergoing coronary angiography. Treatment of CTO has been found to constitute only 7% of PCI~     practice on average. One of the reasons for the under-presentation of CTOs in PCI target~     lesions is the lack of evidence-based medical data on treatment indications, and the~     continued low level of accepted evidence for the treatment of CTOs by PCI in PCI guidelines.~      Patients with a CTO represent patients with stable coronary artery disease. The COURAGE trial~     comparing PCI with optimal medical therapy in stable coronary disease did not show a~     difference in mortality or myocardial infarction between the two treatment options. However,~     CTOs were not included in the COURAGE trial. But that trial did confirm the superiority of~     PCI over OMT in controlling symptoms of angina, with a high cross-over rate to PCI. Whether~     PCI for CTO is superior to OMT in reducing MACE in those patients with a large ischaemic~     burden has never been tested in a randomized controlled trial.~      While there is compelling evidence from registry studies of a clinical and prognostic benefit~     following successful PCI of CTO compared with PCI failure, there has been no randomized~     controlled trial of contemporary PCI using drug-eluting stents versus optimal medical~     therapy. The COURAGE trial nuclear sub-study confirms both that prognosis is closely related~     to the extent of residual ischaemia and that PCI is more effective in reducing residual~     ischaemia than optimal medical therapy alone. This confirms earlier retrospective data~     suggesting that the benefit of PCI is greatest in patients with moderate (10-20%) or severe~     (>20%) ischaemia.~      Study hypothesis: PCI with Biolimus eluting stent implantation plus OMT will be superior to~     OMT alone in improving health status at 12-month follow-up, and will be noninferior with~     respect to the composite of all cause death/ non fatal MI at 36-month follow up, in patients~     with a CTO in an epicardial coronary artery >2.5 mm diameter and chronic stable angina with~     evidence of ischemia and viability in the territory subtended by the CTO~   "
138069|NCT01760070|"~     By combining injection and dissection capability together, O-type Hybrid knife could possibly~     shorten the endoscopic submucosal dissection procedure for upper gastrointestinal neoplasms.~   "
138070|NCT01760057|"~     The proposed study is designed to develop and test the effectiveness of a novel web-based HIV~     intervention to motivate HIV testing among men who have sex with men (MSM). The intervention~     arm includes the delivery of videos tailored to the reasons MSM have for not getting tested~     for HIV, as well as HIV testing motivational messages sent via mobile-phone text messaging,~     e-mail or instant messaging. The intervention and assessments will be guided by the~     Information-Motivation-Behavioral skills model, the Health Belief Model and the Stages of~     Change theory. The control intervention will be a health promotion message (similar in~     content to other Peruvian websites) with an invitation for free HIV testing. Testing will be~     offered at the Via Libre and Epicentro clinic, and at a mobile unit whose location will be~     determined based on participants' demand. The outcomes evaluated will be intention to get~     tested and actual HIV testing among MSM of each of the trial arms.~   "
138071|NCT01760044|"~     Investigators are conducting research about oxygen levels in the body and whether it is~     possible to use a device to measure oxygen in the body's tissues noninvasively, without blood~     draws or a catheter (a plastic tube placed in a vein). Investigators would like to know how~     this device compares to standard measurements using blood from a catheter. This may help~     treat patients who may not be getting enough oxygen to their body.~   "
138072|NCT01760031|"~     Remote ischemic preconditioning reduces the incidence of contrast-induced acute kidney injury~     in patients undergoing elective coronary angiography. This study was designed to acquire~     long-term data of initially randomized patients in the RenPro Trial.~   "
138073|NCT01760018|"~     Total intravenous anesthesia (TIVA) and inhalation anesthesia are both widely and safely~     used, and there are many clinical trials comparing these on various aspects of anesthesia.~     However, there have not been studies comparing the quality of recovery from the different~     methods of general anesthesia. In this study, the investigators compare the functional~     recovery after general anesthesia in TIVA and inhalation anesthesia with QoR-40~     questionnaire.~   "
138074|NCT01760005|"~     The purpose of this study is to assess the safety, tolerability, biomarker and cognitive~     efficacy of investigational products in subjects who are known to have an Alzheimer's~     disease-causing mutation by determining if treatment with the study drug slows the rate of~     progression of cognitive impairment and improves disease-related biomarkers.~   "
138075|NCT01759992|"~     The global loss of muscle mass and strength associated with aging is a cause of functional~     impairment and disability, particularly in the older elderly (>80 years). Respiratory~     function can be severely compromised if there is a decrease of respiratory (RM) strength~     complicated by the presence of comorbidities and physical immobility. In this context, the~     need for supportive services involves the need for long-term care and consequently the~     institutionalization.~      Previous studies have shown that the increase of RM strength has positive healthy effects,~     such as the increase in functional capacity, the decrease in RM fatigue, the decrease of~     dyspnoea and the improvement of quality of life, both in healthy people and patients.~     Therefore, specific RM training may be regarded as a beneficial alternative to improve RM~     function, and thus prevent physical and clinical deterioration in this frail population.~      Study hypothesis: The inspiratory muscle training (IMT) would improve respiratory muscle~     strength and endurance, exercise capacity and quality of life in an elderly population, who~     are unable to engage in general exercise conditioning.~   "
138076|NCT01759979|"~     Very large bile duct stones are difficult to remove. The prefered method involves an~     endoscopic procedure known as endoscopic retrograde cholangiopancreatography (ERCP)performed~     using a special side viewing endoscope. In the past small baskets passed through the scope~     into the bile duct have been used to remove most stones using mechanical force.~      Recently very small scopes known as cholangioscope have been introduced through the side~     viewing endoscope directly into the bile duct. These cholangioscopes may be used to guide~     laser therapy of bile duct stones. The investigators suspect that stone destruction using~     cholangioscopy guided laser stone destruction may enable bile duct stones to be removed more~     quickly and safely when added to the mechanical techniques.~   "
138077|NCT01759966|"~     The purpose of this prospective study is to investigate denervation (ie. surgical cutting of~     autonomic nerves) and re-innervation (ie. growth of autonomic nerves) in heart transplant~     recipients. More specifically, we focus on:~        1. The physiological consequences of denervation, in particular its consequences for~          clinical symptoms, orthostatic tolerance (ie. the ability to stand upright) and exercise~          capacity. We hypothesize that denervation has negative consequences for all these~          factors.~        2. The pathological consequences of denervation and reinnervation, in particular its~          association to acute rejection and coronary artery disease (cardiac allograft~          vasculopathy, CAV). We hypothesize that reinnervation protects against acute rejection~          and development of CAV~        3. Donor and recipient factors associated with the reinnervation process. We hypothesize~          that characteristics of the surgical procedure (such as aorta cross-clamp time) as well~          as the rehabilitation process of the recipient (such as physical activity) impacts on~          the reinnervation process.~   "
138078|NCT01759953|"~     Background: Physicians´ lack of knowledge contributes to underuse of insulin and poor~     glycemic control in adults with diabetes mellitus (DM). Traditional continuing medical~     education have limited efficacy, so new approaches are required.~      Objective: We report the design of a trial to assess the educational efficacy of InsuOnline©,~     a game for education of primary care physicians (PCPs) on initiation and adjustment of~     insulin for the treatment of DM, which was designed to be: a) educationally adequate; and b)~     self-motivating and attractive.~      Methods: A multidisciplinary team, with endocrinologists, experts in medical education, and~     programmers, was assembled for design and development of InsuOnline©, a serious game which~     includes game elements and a well-defined, evidence-based curriculum of topics on insulin~     therapy. The first step of our study will be usability and playability tests, with PCPs and~     medical students, playing the game on a desktop. After that and further adjusts, we will~     perform an unblinded randomized controlled trial, with PCPs who work in the city of Londrina,~     to assess the educational validity of the game. A group of 64 PCPs will play InsuOnline© on~     the web, and the control group, of 64 PCPs, will underwent traditional teaching activities~     (lecture and group discussion). Knowledge on how to initiate and adjust insulin will be~     assessed by a web-based multiple-choice questionnaire, and attitudes regarding~     diabetes/insulin will be assessed by Diabetes Attitude Scale 3, at 3 time points: before,~     immediately after, and 6 months after the intervention. Subjects´ general impressions on the~     interventions will also be assessed by free-text questions. Software logs will be reviewed.~   "
138079|NCT01759940|"~     Carotid endarterectomy is commonly performed under cervical plexus block. This is presumed to~     offer advantages over general anesthesia in terms of monitoring neurological function during~     cross-clamping of the carotid artery since, in conscious patients, speech, cerebration, and~     motor power provide early measures of inadequate cerebral perfusion. Some studies also claim~     lower shunting requirements, lower cardiovascular morbidity, and shorter hospital stay.~      Traditionally, the common methods of cervical plexus block are termed 'deep' or~     'superficial'. The deep block, as described by Moore or Winnie and colleagues, consists of~     identifying the transverse processes of upper cervical vertebrae C2 - C4 and injecting local~     anesthetic directly into the deep (prevertebral) cervical space. This may be achieved either~     as separate injections or as a single injection. The superficial block incorporates a variety~     of procedures. The simplest is a s.c. infiltration of local anesthetic along the posterior~     border of sternocleidomastoid muscle by either the surgeon or the anesthetist.~      An 'intermediate' block is one where the injecting needle pierces the investing fascia of the~     neck, deep to the s.c. layer, but superficial to the deep cervical (prevertebral) fascia. It~     is also possible to use a 'combined block', consisting of a deep injection and a superficial~     or intermediate injection.~      Practitioners may prefer one block to another, but no consensus exists on the efficacy of one~     block when compared with another. However, it has been suggested that complications of the~     technique are related to the deep injection and not the superficial (or intermediate)~     injection. These complications include intrathecal or intravascular injection, respiratory~     problems related to phrenic nerve paralysis, or local anaesthetic toxicity.~      In this study the Influence of the concentration of the local anesthetic ropivacaine on the~     quality of the intermediate cervical plexus block for carotid endarterectomy will be~     evaluated. For this purpose two different concentrations of ropivacaine will be compared~     (3,75% vs 7,5%). The primary endpoint of the study will be the quantity of the additional~     needed local anesthetic to achieve adequate operative analgesia. Furthermore we will record~     the frequency of the most common side effects as well as the patient satisfaction with a~     standardized questionnaire.~   "
138080|NCT01759927|"~     The primary aim of this study is to investigate if and how a physical activity counselor can~     offer an added value in exercise promotion in physically inactive employees. We will explore~     if the physical activity counselor in the workplace setting can motivate sedentary employees~     to engage into systematic participation in sports and/or exercise by means of a short term~     coaching of 12 weeks. We aim to include 300 employees in the physical activity coaching~     process.~   "
138081|NCT01759914|"~     Ocular hypertension and glaucoma are eye conditions associated with abnormally high fluid~     pressure in the eye (called intraocular pressure or IOP). If left untreated, the elevated IOP~     may eventually cause damage to the nerve of the eye and potential impairment of vision.~      The use of certain drugs has been identified as a risk factor for raised IOP, including~     various forms of administration of corticosteroids. Corticosteroids can also lead to~     cataract, which is clouding of the lens in the eye that can affect vision.~      In this research study, we would like to find out whether the use of corticosteroids in our~     dermatology clinic leads to raised IOP, in order to identify patients at risk and to allow~     them to be more closely monitored than others. It is important to identify those patients who~     have a corticosteroid-induced pressure rise early enough to prevent them from permanent~     glaucomatous visual loss.~   "
138082|NCT01759901|"~     Bleeding is a major problem during liver resection. Vascular inflow occlusion, also known as~     Pringle maneuver, has been commonly employed to reduce blood loss during liver surgery.~     However, Pringle maneuver might cause ischaemic insult to the remnant liver and lead to~     post-operative liver dysfunction.~      The investigators hypothesize that liver resection without the use of vascular inflow~     occlusion (Pringle maneuver) is associated with lower postoperative complications rate.~      The aim of this study is to evaluate whether elective open liver resection without vascular~     inflow occlusion (Pringle Maneuvre) would lead to a reduction of post-operative surgical~     complications in patient with hepatocellular carcinoma.~      Eligible patients undergoing liver resection in the Prince of Wales Hospital will be~     recruited and randomized into 2 study arms comparing the effect of Pringle maneuver.~   "
138083|NCT01759888|"~     The primary objective of this protocol is to access the utility of 18F-DTBZ PET imaging as an~     in vivo biomarker to monitor neurodegeneration of both PD mouse models and PD patients.~     Secondary, the investigators will analyze progression rate of genetic-proving PARK8 and PARK6~     patients who have homogeneous phenotype and genotype by 18F-DTBZ PET imaging.~   "
138084|NCT01759875|"~     The goal of this study is to evaluate the ability of a natural supplement (betaine~     hydrochloride) to affect the absorption of atazanavir in healthy volunteers. The~     investigators predict that betaine hydrochloride will increase the absorption of atazanavir~     in volunteers pre-treated with proton-pump inhibitors (PPIs).~   "
138085|NCT01759862|"~     The aim of this study is to evaluate whether peri-transplant administration of a drug named~     aminophylline to children undergoing a kidney transplant from deceased donors improves early~     graft function and also projects on long term graft function.~   "
138086|NCT01759849|"~     This study examines in vitro blockade of signaling through the β-chain, on viability,~     activation and differentiation of eosinophils and their progenitors collected in sputum,~     blood and bone marrow samples pre and post-allergen challenge from mild atopic asthmatic~     subjects.~   "
138758|NCT01751061|"~     Deciding about prolonged life support for critically ill patients can be very difficult.~     Therefore, the investigators are doing a study to see if an internet-based decision aid can~     improve the quality of decision making for substitute decision makers of patients who are in~     the intensive care unit (ICU).~   "
138089|NCT01759810|"~     Trial Hypothesis: Acute, progressing lethal neurooncological process can be transferred into~     chronic and non-lethal, the survival rates and life quality can be improved by of control of~     tumor cells (TCs) quantity and targeted regulation of effector functions of tumor stem cells~     (TSCs).~      Brief Description:~      The first line therapy of glioblastoma multiforme (GBM) involves allogeneic haploidentical~     hematopoietic stem cells (HSCs), dendritic vaccine (DV) and cytotoxic lymphocytes (CTLs).~      TCs and TSCs are isolated from GBM sample. Dendritic cells are isolated from peripheral blood~     mononuclear cells and cultured. Tumor sample provides tumor specific antigens to prepare DV.~     CTLs are obtained from peripheral blood after DV administrations. HSCs are harvested from~     closely related donor after granulocyte-colony-stimulating factor (G-CSF) administration.~      Allogeneic HSCs are administered intrathecally 5 times every 2 weeks, at day 1, 14, 28, 42,~     56. DV is given 3 times every 2 weeks (day 14, 28, 42) subcutaneously in four points. CTLs~     are administered every 2 weeks for 3 months, then 3 times every 1 month intrathecally. Six~     months after the therapy completion, the efficiency is evaluated and the cohort demonstrating~     efficiency continues the therapy, while cohort demonstrating no efficiency is transferred to~     active comparator arm.~      Second line therapy involves DV with recombinant proteins, CTLs and autologous HSC with~     modified proteome. Autologous HSCs are mobilized by G-CSF.~      Carcinogenesis-free intracellular pathways of signal transduction able to respond to targeted~     regulation of therapeutic cell systems with specific properties, are detected in TSCs using~     complete transcriptome profiling of gene expression, proteome mapping and profiling of~     proteins, bioinformation and mathematical analysis and mathematical modeling of protein~     profiles. To find key oncospecific proteins in TSCs and TCs, the targets for TSCs regulation~     are detected, as well as protein ligands able to regulate reproductive and proliferative~     properties of TSCs.~      Using these data of TCs and TSCs proteins, the cell preparations to initiate adoptive immune~     response are prepared: DV loaded with recombinant proteins analogous to key tumor antigens,~     CTLs and autologous proteome-modified HSCs.~      Autologous proteome-modified HSCs, DV and CTLs are administered as in the first line therapy.~   "
138090|NCT01759797|"~     ALS is a debilitating disease with varied etiology characterized by rapidly progressive~     weakness, muscle atrophy and fasciculations, muscle spasticity, difficulty speaking~     (dysarthria), difficulty swallowing (dysphagia), and difficulty breathing (dyspnea). ALS is~     the most common of the five motor neuron diseases.Riluzole (Rilutek) is the only treatment~     that has been found to improve survival but only to a modest extent. It lengthens survival by~     several months, and may have a greater survival benefit for those with a bulbar onset. It~     also extends the time before a person needs ventilation support.Stem cell transplantation is~     a new hopeful way to improve the patients conditions and reduce the period of disabilities.~   "
138091|NCT01759784|"~     ALS is a debilitating disease with varied etiology characterized by rapidly progressive~     weakness, muscle atrophy and fasciculations, muscle spasticity, difficulty speaking~     (dysarthria), difficulty swallowing (dysphagia), and difficulty breathing (dyspnea). ALS is~     the most common of the five motor neuron diseases.Riluzole (Rilutek) is the only treatment~     that has been found to improve survival but only to a modest extent. It lengthens survival by~     several months, and may have a greater survival benefit for those with a bulbar onset. It~     also extends the time before a person needs ventilation support.Stem cell transplantation is~     a new hopeful way to improve the patients conditions and reduce the period of disabilities.~   "
138092|NCT01759771|"~     Vitamin D promotes the differentiation of prostate cancer cells and maintains the~     differentiated phenotype of prostate epithelial cells. The results of the investigators'~     clinical studies indicate that vitamin D3 supplementation results in a decrease of positive~     cancer cores at repeat biopsy in subjects with low-risk prostate cancer. The investigators~     hypothesize that Veterans who have early-stage prostate cancer and who take vitamin D3 at~     4000 international units per day (intervention group) will show an improvement in the number~     of positive cores and in Gleason score at repeat biopsy, and a decreased likelihood of~     undergoing definitive treatment (prostatectomy or radiation therapy), compared to Veteran~     subjects taking placebo (control group).~   "
138093|NCT01759758|"~     The investigators are conducting a randomized clinical trial comparing two types of splints~     for treatment of Boxer's fractures in children up to age 17 inclusive. Patients who meet~     inclusion criteria will be randomized to either Group A or B. Group A will be treated with~     the conventional plaster ulnar gutter splint. Group B will be treated with a custom molded~     thermoplastic hand-based splint. The thermoplastic splint will provide support of the~     metacarpal but does not immobilize the patient's wrist or interphalangeal joints.~      Hypothesis: Is plaster splint immobilization an equivalent treatment method to a custom made~     thermoplastic splint for a fifth metacarpal neck fracture? Will one splint be tolerated~     better than the other and will the compliance be different between the two groups?~   "
138094|NCT01759745|"~     Blepharospasm (BEB) is a focal dystonia characterized by forceful, involuntary contractions~     of the orbicularis oculi muscle. (Jankovic et al 1983) Patients with BEB report task and~     situation specific modulations of their symptoms. So called sensory tricks are actions that~     minimize symptoms and include concentrating, talking, pulling on the eyelids, blowing air,~     and applying pressure to the periocular or temple region. (Weiner 1984) Many patients~     describe that other tasks/situations are exacerbate their symptoms specifically under bright~     fluorescent lights and stress. (Burke 1984) Earlier studies showed that blink patterns differ~     between BEB patients and control during rest, reading and talking.~      In healthy subjects gaze evoked blinks are a physiologic phenomenon: initiation of gaze~     shifts evoke a blink, blinks facilitate gaze shifts. (Evinger 1994) In healthy subjects~     emotions and thoughts influence gaze shifts and blink rate. (Leal 2008, de Genaro 1988)~     However, little is known about various task and emotion specific influences on symptoms of~     BEB (e.g. expecting a gaze shift might worsen symptoms while driving a car).~      Differences in emotion and gaze related blink patterns between patients and controls will~     contribute to the understanding of the pathophysiology of BEB. This might offer new~     therapeutic options, e.g. symptom modulation.~      The investigators hypothesize that blink patterns, measured by duration and frequency of~     pupillary occlusion differ between patients and control, when performing gaze shifts and~     emotion related blink patterns, measured by duration and frequency of pupillary occlusion~     differ between patients and controls.~      The aim of this pilot trial is to assess differences in gaze evoked and emotion related blink~     patterns between patients and controls. These differences might contribute to the~     understanding of the pathophysiology of BEB.~   "
138095|NCT01759732|"~     Rationale: Fludarabine, cyclophosphamide, anti-thymocyte globulin and low-dose total body~     irradiation (LD-TBI) may induce the engraftment cross the immunologic barrier in the setting~     of HLA-haploidentical allogeneic hematopoietic cell transplantation. In addition, depletion~     of CD3 cells may contribute to prevent developing severe acute graft versus host disease~     (GVHD) in haploidentical transplantation.~      Purpose: Phase II trials to evaluate the efficacy of haploidentical stem cell transplantation~     with fixed dose of T cells after in vitro T cell depletion using CD3 monoclonal antibody for~     children with acquired severe aplastic anemia~   "
138096|NCT01759719|"~     Recent reports have described cases of novel thin-strut coronary stent longitudinal~     deformation during or after deployment and a biomechanical analysis have suggested increased~     susceptibility for such a complication for the platinum chromium (PtCr) coronary stent~     platforms . This analysis aims to assess the incidence of longitudinal stent deformation for~     PtCr stents in a large single centre all-comers population using quantitative angiographic~     analysis (QCA).~   "
138097|NCT01759706|"~     The purpose of this study is to assess the adherence to an enhanced recovery after surgery~     (ERAS) pathway and the impact of the ERAS protocol on postoperative short-term outcome in~     patients undergoing pancreaticoduodenectomy (PD).~   "
138099|NCT01759680|"~     Tiredness, lack of motivation and low compliance can be observed in nursing home residents~     during the practice of physical activity. Because exercises should not be too vigorous, whole~     body vibration could potentially be an effective alternative.~      The objective of this randomized controlled trial is to assess the impact of 3-month training~     by whole body vibration on the risk of falls among nursing home residents.~      Patients were randomized into two groups: the whole body vibration group which received 3~     training sessions every week composed of 5 series of only 15 seconds of vibrations at 30 Hz~     intensity and a control group with normal daily life for the whole study period.~      The impact of this training on the risk of falls was assessed blindly by three tests: the~     Tinetti Test, the Timed Up and Go test and a quantitative evaluation of a 10-second walk~     performed with a tri-axial accelerometer.~   "
138100|NCT01759667|"~     Bariatric surgery is the only satisfactory treatment for loss and weight maintenance in obese~     patients. This loss is a result of several factors that go beyond the simple anatomical~     abnormality of the gastrointestinal tract and may be the product of post-op energy~     expenditure changes. The respiratory quotient (RQ) and diet-induced thermogenesis (DIT) are~     important components of energy expenditure and possible changes in them can perform an~     important role in weight loss after Roux-en-Y Gastric Bypass (RYGB). Previously, we conducted~     a cross-sectional study where we measured the RQ and DIT in pre and post-op RYGB patients,~     which was published in the Surgery of Obesity and Related Diseases (SOARD) journal. The~     objective of this study is to perform a prospective analysis of these same variables (RQ and~     DIT), evaluating them in the same patients, when pre and postoperatively.~   "
138101|NCT01759654|"~     This is an open study of the use of AdimFlu-V (2012-2013 season) vaccine in non-elderly and~     elderly subjects. All participates will receive one dose of vaccine (0.5 ml) by intramuscular~     injection into the upper arm. Safety outcomes included immediate reactions at the time of~     vaccination, solicited local and systemic reactions for 7 days, unsolicited adverse events~     for 28 days, and serious adverse events. Sera prepared from blood samples will be collected~     from each subject immediately prior to, and 28 days after vaccination. Anti-hemagglutinin~     (HA) antibody titers will be determined using the WHO hemagglutination inhibition reference~     technique. The central laboratory who is responsible for antibody titrations will not be~     aware of the background of blood samples (e.g., pre- or post-serum), it is also called~     observer-blinded. All participates will be followed, either by clinical visit or by telephone~     contact, for 8 weeks after the vaccination for safety reasons.~   "
138102|NCT01759641|"~     The aim of the present work was to analyze the short-term variability of SO2 during~     hemodialysis in sessions with and without hypotension to correlate the SO2 variability to~     hemodynamic instability.~   "
138103|NCT01759628|"~     The aim of study was to evaluate the effect of helicobacter pylori eradication on liver~     function tests, lipid profile, homeostasis model assessment-IR (HOMA-IR) index, and~     anthropometric measurements (body mass index and waist circumference)in subjects with~     non-alcoholic fatty liver disease.~   "
138104|NCT01759615|"~     This research is being conducted in preterm newborns with 'in utero' growth restriction due~     to inadequate blood flow from the mother to the baby. These deprived babies adapt to the not~     so conducive uterine environment by certain adjustments in blood supply to internal organs~     thereby permitting as best as possible blood flow to brain heart etc., which are the vital~     organs and whose adequate functioning is required for survival. In this bargain the gut~     (intestines) gets poor blood supply and hence its appropriate functioning is jeopardized. In~     the past such babies (after birth) were not fed for days together which compromised their~     growth even further. Premature growth restricted' babies are at increased risk of further~     growth faltering if not fed in time as also to a condition called 'Necrotising enterocolitis'~     if fed liberally like other healthy neonates, characterized by abdominal distension, blood in~     stools and inability to feed for much longer duration thereby further affecting growth. This~     study is evaluating a feeding schedule of early versus late initiation of feeding to arrive~     at the best time to feed such doubly jeopardized premature growth restricted babies to avert~     the above mentioned consequences.~      No study has been conducted in India to confirm the aforementioned fact and hence this study~     has been planned. The information learned from this study will help us to feed these small~     premature as well as growth restricted babies with AREDF better which will go a long way in~     the care of such preterm growth restricted newborns.~   "
138105|NCT01759602|"~     The overall objective is to evaluate the tolerability/safety and preliminary efficacy of~     CINRYZE® (C1 esterase inhibitor [human]) as add-on therapy for treatment of acute optic~     neuritis and/or transverse myelitis in NMO and NMOSD.~      Primary Objective: To evaluate the safety and tolerability of 3-5 doses of 1000 - 2000 Units~     intravenous CINRYZE in NMO/NMOSD patients during an acute exacerbation.~      Secondary Objectives:~        -  To determine the frequency of adverse events with CINRYZE in this patient population.~        -  To determine the effect of CINRYZE on NMO clinical scores (Expanded Disability Status~          Scale and Low Contrast Visual Acuity).~        -  To compare the change in MRI lesion size and extent following a course of CINRYZE.~   "
138106|NCT01759589|"~     To compare the effectiveness of three different anesthetic regimens (propofol,~     remifentanil-propofol and sevoflurane in ECT.~   "
138107|NCT01759576|"~     The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the~     drug) and pharmacodynamics (ie, how the drug affects the body) of canagliflozin~     (JNJ-28431754) after administration of a single dose to non-diabetic volunteers with normal~     kidney function and non-diabetic volunteers with varying degrees of kidney impairment~     (including volunteers with end-stage renal disease requiring hemodialysis).~   "
138108|NCT01759563|"~     Assessment of safety and feasibility of using a nasopharyngeal cooling technique to provide~     targeted brain cooling during percutaneous implantation of aortic valves. Was it possible to~     obtain brain temperatures below 34° within a reasonable time interval (max of 1hr) without~     delaying the procedure of valve implantation.~   "
138143|NCT01759108|"~     Xerostomia is a major distressing symptom in Sjőgren's syndrome(SS). Preclinical and clinical~     studies have demonstrated an increase in saliva volume following rebamipide administration.We~     thus hypothesize that rebamipide may be efficacious in the treatment of dry mouth symptoms~     related to Sjőgren's syndrome.We will recruit SS patients in a randomized placebo-controlled~     trial for 12 weeks. The main outcome measure that will concern us is patient-assessed~     improvement of dry mouth symptoms and increase in salivary secretion Safety and efficacy was~     assessed at each visit.~   "
138109|NCT01759550|"~     The study is primarily to evaluate the safety and efficacy of the LigaSure Advance™ Pistol~     Grip and LigaSure™ Blunt Tip using the Force Triad™ Energy Platform during Roux-en-Y and~     gastric reduction procedures (sleeve gastrectomy or placation), respectively. Also, Economic~     value of using LigaSure in gastric surgeries will be appraised.~      In this prospective case series, 60 patients previously scheduled to undergo a Roux-en-Y or~     gastric reduction procedure (sleeve gastrectomy or placation) will have hemostasis controlled~     with LigaSure Advance ™ Pistol Grip or LigaSure™ Blunt Tip, respectively. All subjects~     undergoing Roux-en-Y or gastric reduction procedures (sleeve gastrectomy or placation)~     procedure at Durham Regional Hospital will be recruited.~      Data Analysis will be performed using the data collected in the software program titled~     MetaBar at Duke University Medical Center. Categorical variables will be summarized as~     proportions for each category; continuous measures will be summarized by mean and standard~     deviation or median and range as appropriated for the data distribution. Procedure-related~     risks are those typically associated with gastric procedures and general anesthesia including~     intra-operative bleeding, infection, and injury to surrounding organs and structures. Device~     related risks include those normally associated with the use of electrosurgery including~     intra-operative bleeding, unintended tissue burns, electrical shock, and electrical~     stimulation of muscles and nerves.~   "
138110|NCT01759537|"~     The purpose of this study is to test two standard of care techniques of placing dental~     implants, and to compare how people's bones and gums respond to two different depths at which~     implants are placed.~   "
138111|NCT01759524|"~     Clonidine as an adjuvant to local anaesthetics prolongs the postoperative analgesia. It is~     predominantly an alpha 2 agonist, but does have some alpha 1 activity. Clonidine alone~     produces analgesia. When administered centrally its effects are predominantly due to its~     alpha 2 activity. When administered peripherally it prolongs the analgesia through its~     vasoconstrictor effects and by reducing the clearance of local anaesthetic. Another~     possibility is that it prolongs analgesia of peripheral nerve blocks due to a~     hyperpolarisation current .Clonidine has been used successfully both for upper and lower limb~     blocks. Studies of clonidine for lower limb blocks have produced equivocal results . A major~     concern with the lower limb blocks is the risk of falls associated with prolonged motor~     blockade during early mobilisation. Clonidine has been shown to intensify and prolong the~     motor blockade produced by long acting local anaesthetics. Lidocaine when used in combination~     with clonidine can increase the duration of analgesia to 8-18 hrs. Greater doses of clonidine~     are associated with longer analgesia but with more side effects. Clonidine in a dose of 90~     mcg administered with local anaesthetics can produce analgesia for up to 10 hrs with minimal~     side effects. The aim of this study is to compare lidocaine 2% + clonidine 1.5mcg/kg with~     bupivacaine alone in terms of block selectivity for combined sciatic -saphenous nerve block~     in patients under going semi elective foot/ankle procedures.~   "
138112|NCT01759511|"~     The primary objective of this study is to evaluate the long term safety and tolerability of~     simtuzumab (GS-6624) in participants with idiopathic pulmonary fibrosis (IPF) who had~     previously participated in Gilead clinical trial AB0024-201.~   "
138113|NCT01759498|"~     Since hydrogen therapy in humans seems to be beneficial for treating inflammation,~     ischemia-reperfusion injury and oxidative stress, it seems plausible to evaluate the effects~     of exogenously administered hydrogen as an element of instant management of sport-related~     soft tissue injuries (e.g. muscle sprain, ligament strain, tendonitis, contusion). The main~     aim of the present study will be to examine the effects of two-week hydrogen-rich oral and~     topical administration on the inflammation, recovery and functional abilities in competitive~     male and female athletes after acute soft-tissue injury. During the season 2012/2013 (from~     February to June) subjects (36 professional athletes) will be recruited and examined by~     certified sports medicine specialist in the out-patient clinics of the Center for Health,~     Exercise and Sport Sciences in the first 24 hours after the sport-related soft tissue injury~     was sustained. The subjects will be allocated to a double-blind design to three randomly~     assigned trials. During the period of 2 weeks subjects in the placebo group (PLA) will~     receive traditional treatment protocol after the soft-tissue injury, consisting of RICE~     protocol during the first 48 h and sub-acute protocol thereafter. Subjects in the first~     experimental group will follow the above procedures with additional administration of oral~     hydrogen-rich capsules (4 capsules three times per day) throughout the study. Subjects in the~     second experimental group will follow the procedures of first experimental group with~     additional administration of hydrogen-rick packs 6 times per day for 20 minutes throughout~     the study. Participants will be evaluated at the beginning of the study (e.g. at the time of~     the injury report), after 7 and 14 days after baseline testing for: a) serum C-reactive~     protein, plasma viscosity and interleukin 6 level, b) pain intensity during rest and walking,~     c) degree of joint swelling, d) passive joint flexibility, and, e) subjective side-effects.~     The investigators expect that the administration of hydrogen will significantly improve~     inflammation outcomes (e.g. decrease in serum C-reactive protein) as compared to the placebo,~     with topical hydrogen administration will additionally improve post-injury recovery outcomes~     (e.g. pain intensity, degree of swelling). These results could support the hypothesis that~     hydrogen-rich intervention may be included as an element of immediate treatment for~     sport-related soft tissue injuries.~   "
138114|NCT01759485|"~     Background: Despite improvements in medications, treatment delivery and rehabilitation,~     schizophrenia outcomes remain suboptimal. There are a proportion of 30-40%~     treatment-resistant schizophrenia patients. Multiple lines of evidence suggest that vitamin D~     is a neuro-active steroid that acts on brain development, leading to alterations in brain~     neurochemistry and adult brain function. Early deficiencies have been linked with~     neuropsychiatric disorders, such as schizophrenia, and adult deficiencies have been~     associated with adverse brain outcomes, including Parkinson's disease, Alzheimer's disease,~     depression and cognitive decline. Ecological studies support a potential role for vitamin D~     in schizophrenia. These data include studies that have explored the association between~     schizophrenia and winter/spring birth and also the apparent increased incidence and~     prevalence of schizophrenia at higher latitudes. Objective: To evaluate the effect of~     vitamin-D supplementation on the mental state of clozapine-treated chronic schizophrenia~     patients, and the relation of disease severity to serum vitamin D levels. Methods: the~     investigators will use a prospective, interventional, longitudinal, double blinded,~     placebo-controlled, randomized design. The investigators will recruit 50 clozapine-treated~     chronic schizophrenia patients, with low level of serum vitamin-D, that will be randomly~     assigned (1:1 ratio) to receive either weekly oral drops of vitamin D (Cholecalciferol) or~     oral drops of placebo for 8 weeks follow-up. Repeated assessments will include: clinical~     severity scales (PANSS, CGI), side effects (SAS, BARS, clozapine side effects), cognitive~     (MoCA), metabolic parameters and laboratory data. Patients who were assigned to placebo will~     be supplemented with vitamin D after the 8 weeks period, and then will be assessed again with~     the same protocol of vitamin D treated patients. All participants will be assessed again~     after 24 weeks after vitamin D initiation. Analysis: the investigators will use on-way ANOVA~     with repeated measures for comparison of vitamin D and control groups. The investigators will~     apply intention to treat and LOCF.~   "
138115|NCT01759472|"~     To determine whether LTD4-BPT could be an effective indicator for predicting efficacy of~     anti-leukotriene therapy, allowing objective proofs for the use of LTRA among asthmatics in a~     specific sensitive to leukotriene population of asthma.~      Hypothesis ：Monteluakst can better improve pre-challenge FEV1 from baseline in~     leukotriene-sensitive group than leukotriene-insensitive group.~   "
138144|NCT01759095|"~     The purpose of this study is to determine the benefit of patients using a multidrug blister~     packs after discharged from an university hospital to their homes.~   "
146456|NCT01650077|"~     Non-interventional study consisting of a population of patients who had received for soft~     tissue sarcoma by at least 2 courses of Yondelis® at a dose of 1.5 mg / m² / 3 weeks after~     failure or intolerance to doxorubicin / ifosfamide from 2007 to 2011.~   "
138116|NCT01759459|"~     The purpose of this study is to compare the pain level felt by patients when receiving~     placement of a peripheral intravenous catheter (IV line) following the administration of a~     local anesthetic. The local anesthetics tested will be lidocaine, buffered lidocaine, and~     bacteriostatic normal saline. Lidocaine is commonly used as a premedication for reducing the~     pain upon insertion of peripheral IV lines. However, due to its acidic nature, the lidocaine~     itself may cause pain upon administration. To help counter this discomfort, pharmacies can~     buffer the lidocaine using sodium bicarbonate, which increases the pH to a neutral value,~     resulting in less pain. Bacteriostatic normal saline has also been used for local anesthesia~     with peripheral IV placement, particularly in patients with a lidocaine allergy, as it~     contains benzyl alcohol which acts as a local anesthetic.~      There are minimal reports from the literature that directly compare patient reported pain of~     all three agents to one another, although studies do exist that have compared buffered~     lidocaine versus lidocaine and buffered lidocaine versus bacteriostatic normal saline. To~     address this comparison gap, the following research questions need to be asked: which~     anesthetic agent is the superior premedication for reducing the amount of pain upon~     administration of the local anesthetic itself and for the pain associated with the peripheral~     insertion of the catheter? The hypothesis of the investigators is that there is not a~     significant difference in the degree of pain scales between the anesthetic agents to justify~     the pharmacoeconomic costs associated with compounding buffered lidocaine.~      The primary outcome measured in this study will be the level of pain reported by the patient~     upon administration of the local anesthetic and upon insertion of the peripheral intravenous~     catheter. A secondary outcome includes a pharmacoeconomic analysis that will look~     specifically at the cost-savings of using one agent over the other and will take into account~     the daily time allocated to pharmacy technicians and pharmacists for compounding and~     verifying buffered lidocaine.~   "
138117|NCT01759446|"~     To determine the relative abuse potential of VYCAVERT (hydrocodone bitartrate and~     acetaminophen) compared to GENERIC H/A (hydrocodone bitartrate and acetaminophen) when~     crushed and administered intranasally to non dependent, recreational opioid users.~   "
138118|NCT01759433|"~     The reference intervals for Sonoclot Analysis may be different between Chinese and American.~     So far, no reference interval has been established in Chinese for Sonoclot Analysis. This~     study is going to establish the first Chinese reference intervals for Sonoclot Analysis and~     test whether they are different from American reference intervals.~   "
138119|NCT01759420|"~     The purpose of this study is to assess the use of the medication ondansetron (zofran) in the~     emergency department. There are studies of the ability of ondansetron to cause a prolongation~     in the QT interval (a certain measurement on an EKG) in anesthesia and cancer patients, but~     not on emergency department patients. This is an observational study where patients that are~     going to receive the anti-nausea medicine ondansetron in the emergency department will have~     an EKG performed every 2 minutes for 20 minutes to determine if the QT interval prolongs and~     returns to normal in that time period. Any serious outcomes will be reported. There is~     expected to be no adverse outcomes from this routinely used medication.~   "
138120|NCT01759407|"~     The purpose of this study is to prospectively compare post-operative pain relief in pediatric~     patients undergoing traumatic femur fracture repair who have received either a femoral nerve~     block with a lateral femoral cutaneous nerve block or a standard anesthetic for analgesia.~   "
138121|NCT01759394|"~     A Randomized, Open-label, Three-period, Partial-replicate Design Study to Evaluate the Inter-~     and Intrasubject variability of the Avatrombopag To-be-marketed Formulation Administered as~     Single Doses of 40 mg (all doses are expressed as avatrombopag, the amount of free base) to~     healthy subjects Receiving a low-fat Meal.~   "
138122|NCT01759381|"~     The purpose of this study is to evaluate the outcome of incisional negative pressure wound~     therapy in preventing surgical site infections and wound complications (dehiscence) in~     high-risk patients undergoing complex spinal surgery.~   "
138123|NCT01759368|"~     In the study benefits of using mobile phone assisted remote patient monitoring including~     self-measurements of blood pressure, heart rate and weight as well as monitoring of personal~     health status are investigated in the care of heart failure patients.~   "
138124|NCT01759355|"~     This is a two arm, single center feasibility study of 20 patients with non-metastatic~     cervical cancer managed with surgery and/or chemoradiation therapy at UNC Hospitals. Subjects~     will undergo PET/MRI scans before, during (chemoradiation group only), and after treatment.~   "
138125|NCT01759342|"~     This protocol was designed to assess if when subjects with CF are admitted to the hospital~     for a pulmonary exacerbation if a comprehensive exercise program (moderate to high intensity~     aerobic, resistance, flexibility and balance exercises) was superior to our usual care~     intervention (30 min/day of self selected mode and intensity of exercise) in improving~     aerobic capacity, muscle strength/power, flexibility and balance.~   "
138126|NCT01759329|"~     Epidemiological studies have indicated a positive health impact of coffee. Nevertheless,~     intervention studies testing the effect of daily coffee consumption over a longer period are~     lacking so far. Moreover, there is a lack of knowledge about the properties of different~     coffees and their influence on weight development. Therefore, we tested the effect of two~     coffees differing in their alkyl pyridine content over a period of 3 months on weight~     development.~   "
138127|NCT01759316|"~     Heliox can lower respiratory resistance, improve the oxygenation, reduce respiratory distress~     and lung injury caused by mechanical ventilation.~   "
138128|NCT01759303|"~     The purpose of this study is to determine the 4-month Progression-Free Survival (PFS), with~     demonstrated increase in tumor doubling time, of eligible subjects treated with pazopanib~     according to RECIST version 1.1 guidelines.~   "
138129|NCT01759290|"~     ABSORB FIRST is a prospective, multi-center registry. The objectives of the study are to:~        -  Provide ongoing post-market surveillance for documentation of safety, performance and~          clinical outcomes of the Absorb BVS (Bioresorbable Vascular Scaffold) System in daily~          percutaneous coronary intervention (PCI) practice per Instructions for Use (IFU,~          on-label use).~        -  To evaluate the safety and performance of 12 mm or shorter Absorb BVS in single or~          overlapping use (bailout, optimization of long lesion treatment) for the treatment of~          patients with ischemic heart disease caused by de novo native coronary artery lesion(s)~        -  Collect additional information (e.g. acute success) to evaluate handling and~          implantation of Absorb BVS by physicians under a wide range of commercial use conditions~          and following routine clinical practice.~   "
138156|NCT01758939|"~     Retrospective prospective cohort study aimed at Assessing the predictors to the response to~     the antiviral combined therapy with pegylated Interferon (Both types: Alfa 2 A and Alfa 2 B)~     in hepatitis C virus infected Egyptian patients.~   "
138157|NCT01758926|"~     The study aims to:~        1. To determine the relationship between inflammatory activities and epithelial gaps in IBD~          by CLE and evaluate epithelial gaps healing via dexamethasone treatment.~        2. To demonstrated the alteration of local barrier function in IBD using CLE.~   "
146457|NCT01650064|"~     The purpose of this study is to estimate the survival proportion one year after surgery for~     intertrochanteric fracture in older adults in Latin America.~   "
138130|NCT01759277|"~     Patients typically experience moderate-to-severe pain following knee arthroplasty that is~     usually treated with a combination of oral and intravenous analgesics and enhanced by~     continuous peripheral nerve blocks. There are currently two locations to place a perineural~     catheter to provide analgesia following knee arthroplasty: a femoral nerve catheter and an~     adductor canal catheter. Both have been demonstrated to be effective following knee~     arthroplasty. However, it remains unknown if one location is superior to the other; or, more~     accurately, what the relative benefits are to each technique.~      While femoral CPNB has many benefits, one of the challenges of using this technique is that~     there is a decrease in quadriceps muscle strength which can be a limiting factor for~     rehabilitation. In contrast, the adductor canal catheter affects only the vastus medialis.~     This block may lessen block-induced quadriceps weakness following knee arthroplasty compared~     with a femoral infusion.~      The investigators hypothesize that compared with femoral perineural local anesthetic~     infusion, an adductor canal infusion is associated with a shorter time until four discharge~     criteria are met: (1) adequate analgesia; (2) independence from intravenous analgesics; (3)~     ability to ambulate 30 m; and (4) ability to stand, walk 3 m, and return to a sitting~     position without another's assistance.~   "
138131|NCT01759264|"~     The objective of this observational study was to assess changes in fecal calprotectin levels~     and its suitability as a monitoring tool in participants with moderate-to-severe Crohn's~     Disease who were treated with adalimumab.~   "
138132|NCT01759251|"~     The purposes of this international post-marketing observational program is to investigate~     effectiveness of betahistine dihydrochloride (Betaserc®) tablets and assess the course of~     vestibular vertigo after treatment discontinuation in population of Russia and Ukraine~     outpatients suffering from vestibular vertigo in pragmatic clinical settings. Exploratory~     analyses of results from both participating countries may be expected to provide insights~     about the subjective circumstances of vestibular vertigo patients in a wider than usual range~     of gender, underlying ICD-10 diagnosis, national and cultural situations.~   "
138133|NCT01759238|"~     This study tries to evaluate the role of chemoradiation with capecitabine and bevacizumab in~     oligometastatic patients neither being progressive nor resectable after chemotherapy.~   "
138134|NCT01759225|"~     A computerized registry of cardiovascular disease patients in a large health maintenance~     organization in Israel. The registry is aimed to be used by health professionals to identify~     cardiovascular disease patients and to follow the courses of their illnesses and risk~     factors.~   "
138135|NCT01759212|"~     The aim of the study is to investigate safety and efficacy of intramyocardial implantation of~     allogeneic mesenchymal stem cells in patients with end-stage ischemic cardiomyopathy~     undergoing left ventricular assist device implantation.~   "
138136|NCT01759199|"~     The aim of this study is to show if the six-minute stepper test (ST6) is a sensible marker of~     exercise tolerance evolution during a pulmonary rehabilitation program in people with all~     stages of severity of Chronic Obstructive Pulmonary Disease (COPD).~   "
138137|NCT01759186|"~     The investigators will study the biologic and chemical differences that cause the greater~     incidence, and severity of asthma in women as compared to men. Severe asthma affects boys~     more than girls, while severe asthma in adults is predominantly a disease of women. The~     investigators aim to identify the processes that occur in the body that are behind the onset~     of severe asthma in young women during the teenage years, and the resolution of severe asthma~     in boys. To further evaluate gender influences on asthma, asthmatic women at different stages~     of their menstrual cycle (period) will be also studied. The investigators aim to use~     biomarkers to develop testing procedures that will identify different types or~     characteristics of asthma in men and women; and to follow patients over time to uncover~     relevant clinical outcomes of biomarkers. The investigators anticipate that they will 1)~     develop clinically relevant tests to identify unique types or characteristics of asthma and~     severe asthma; 2) determine outcomes over time of biochemically-defined types of asthma; and~     3) identify the reasons for why adult women are affected more than men with severe asthma.~   "
138138|NCT01759173|"~     Currently, there is no direct, reliable, bed-side, and non-invasive method for assessing~     changes in brain activity associated with concussion. Event Related Potentials (ERPs), which~     are temporal reflections of the neural mass electrical activity of cells in specific regions~     of the brain that occur in response to stimuli, may offer such a method, as they provide both~     a noninvasive and portable measure of brain function. The ERPs provide excellent temporal~     information, but spatial resolution for ERPs has traditionally been limited. However, by~     using high-density electroencephalograph (EEG) recording spatial resolution for ERPs is~     improved significantly. The paradigm for the current study will combine neurophysiological~     knowledge with mathematical signal processing and pattern recognition methods (BNA™) to~     temporally and spatially map brain function, connectivity and synchronization.~      The proposed study will provide additional evidence for the utility and contribution of the~     BNA™ test (reflecting temporal and spatial changes in brain activity as well as brain~     functional connectivity associated with concussion) in concussion management.~   "
138139|NCT01759160|"~     To compare the hemodynamic changes during anesthesia induction between Marsh and Schnider~     plasma TCI models. We put forward a hypothesis that, if one TCI model is associated with much~     more prominent vasodilation effect or cardiac depression, a more sharp decrease in mean~     arterial pressure, systemic vascular resistance , central venous return or stroke volume~     would be observed.~   "
138140|NCT01759147|"~     There are many surgical methods available for the treatment of patients with~     acromioclavicular dislocations. No single method has yet proven to be superior to the others.~      The purpose of this study is to evaluate the clinical outcome and complications associated~     with coracoclavicular ligament repair using autogenous gracilis tendon graft implanted in a~     single transclavicle transcoracoid bone tunnel. The implantation is performed using an~     endobutton system that augments the repair with fibrewires.~      The investigators will prospecitvely follow 30 patients enrolled in the study.~      The hypthesis is that this near anatomical repair of the coracoclavicular ligaments will~     result in good clinical outcome and few complications.~   "
138141|NCT01759134|"~     The objective of this study is to compare the post-discharge growth of preterm infants fed~     with 2 different post discharge formulas.~   "
138145|NCT01759082|"~     Based on the Doppler effect, Laser Doppler Imaging (LDI) uses the interaction of light with~     moving erythrocytes to visualize perfusion in the microcirculatory system.~      The new device to be used in this study have been adapted specifically for the application,~     facilitating its use in clinic. It has been designed to take a standard white light image of~     the area under inspection simultaneously with the perfusion image to facilitate clinical~     assessment.~      Port-wine stain (PWS) birthmarks are congenital, low-flow vascular malformations of the skin~     found in approximately 0.3% of children. They are commonly found on the face and neck and may~     cause serious psychological consequences.~      Lasers are the modality of choice for the treatment of PWS birthmarks. The use of PDL is very~     effective in PWS in closing the blood vessels and diminishing therefore the redness of the~     skin. Repeated laser treatment is necessary to achieve the desired clinical outcome.~      Actually, the efficacy of the treatment of PWS by the laser is obtained by clinical~     inspection and digital photography.~      By measuring the activity and intensity of the microcirculation present in and under the~     skin, the Laser-Doppler (LDI) will be capable of measuring the effect of Pulsed dye laser~     (PDL) treatment for port-wine stains.~   "
138146|NCT01759069|"~     An endodontic treatment is the standard therapy for teeth with periapical periodontitis. The~     overall success rate for this treatment is high; 97% of the treated teeth are retained in the~     oral cavity after 8 years (Salehrabi & Rotstein, 2004). However, there are teeth that have a~     persistent granuloma because of various reasons and need endodontic retreatment or apical~     surgery. Overall results in literature for an endodontic retreatment show a success rate of~     77%-89% (Ng, Mann, & Gulabivala, 2008; Salehrabi & Rotstein, 2010), the results of apical~     surgery are more or less similar (von Arx, 2005). Which of the two methods is preferred for~     failed root canal treatments is dependant on a variety of reasons. (For example an amount of~     gutta-percha outside the apex of the root is better corrected by apical surgery. Persistent~     infection as a result of insufficient gutta-percha amounts in a treated root is best treated~     with an endodontic retreatment.) The overall results in apical surgery have increased the~     past years due to better preparation of the apical end of the root by the use of an~     ultrasonic device (de Lange, Putters, Baas, & van Ingen, 2007) and new materials that are~     used for filling of the rootend e.g. MTA (von Arx, Hanni, & Jensen, 2010)~      Objective of the study:~      The objective of this study is to assess whether or not apical surgery that is carried out~     with the help of a microscope has a higher success rate than apical surgery without the use~     of a microscope. No RCT is found in present literature (Del Fabbro, Taschieri, Lodi, Banfi, &~     Weinstein, 2009).~   "
138147|NCT01759056|"~     The purpose of this study is to evaluate the safety and tolerability as well as the~     pharmacodynamic effects of multiple doses of AVX-470 administered orally in patients with~     active ulcerative colitis.~   "
138148|NCT01759043|"~     The Rapid Trial is a randomized-controlled trial proposed to test the hypothesis that using a~     single guiding catheter for left and right coronary angiography and intervention in patients~     with ST elevation myocardial infarction (STEMI) can reduce procedure time, fluoroscopy time~     and Cath Lab door to balloon(C2B) time when compared with traditional approach which first~     underwent coronary angiography with diagnostic catheter followed by guiding catheter~     selection for intervention.~   "
138149|NCT01759030|"~     The purpose of this study is to prove that efficacy, safety and immunogenicity of BCD-020 is~     equivalent to MabThera when used in combination with methotrexate for the treatment of~     patient with rheumatoid arthritis~   "
138150|NCT01759017|"~     The costs and potential complications (side effects) of therapies currently used to treat~     Crohn's disease could be reduced if a non-invasive test existed that determined which~     therapies benefit patients and which do not. A non-invasive test is a test that does not~     involve cutting or entering the skin. Currently, once therapies are prescribed, doctors rely~     solely on clinical parameters to gauge whether the therapies are helpful. This includes~     evaluation of overall general well-being, abdominal pain, and number of liquid stools per~     day. There is no established and reliable non-invasive test that can predict whether a person~     is responding to therapy early in the course of treatment when these evaluations may be~     inconclusive.~      During this research study we will look for changes in sugar metabolism on low-dose PET/CT~     before and 2 weeks after the first infusion of infliximab therapy. This is to find out if~     these changes can predict clinical response and steroid-free remission at two, six and 12~     months, in patients with Crohn's disease.~   "
138151|NCT01759004|"~     The diagnosis of lipoedema and obesity are often mixed up, unclear stated and often there is~     a misdiagnosis. The primary aim is to investigate whether there is a difference in muscle~     strength between women with lipedema and women with obesity. The secondary aim is to~     investigate whether there is a difference in physical fitness between women with lipedema and~     women with obesity.~   "
138152|NCT01758991|"~     In the acute phase of stroke, dysphagia (difficulty/inability to swallow) is a common problem~     that can have serious consequences such as aspiration pneumonia, increased lenght of~     hospitalisation, and death. It would be interesting to enhance the therapeutic effect of~     swallowing retraining by means on non-invasive brain stimulation such as transcranial direct~     current stimulation (tDCS).~      Hypothesis: during the acute phase of stroke, applying tDCS over the brain during the~     revalidation and/or supervised feeding improves dysphagia significantly when compared to sham~     tDCS.~   "
138153|NCT01758978|"~     The primary objective of this study is to assess the bioequivalence of two 30-mg hydrocodone~     bitartrate extended-release tablets and one 60-mg hydrocodone bitartrate extended-release~     tablet.~   "
138154|NCT01758965|"~     The aim of this study is to assess the effect of Surgicel® Fibrillar as adjuvant treatment to~     H2RA on preventing ulcer bleeding after ESD for gastric epithelial tumors~   "
138155|NCT01758952|"~     Stroke is an important cause of perioperative morbidity and mortality, particularly in~     patients > 60 years. In cardiac, neurological and carotid surgery the incidence is known to~     be high (2.2-5.2%). However, little is known regarding perioperative stroke following other~     types of surgery including general, urological, orthopedic, thoracic and gynecological~     procedures. We therefore propose to undertake a multicenter, observational cohort study, to~     determine the current incidence of, the risk factors for, and outcome associated with~     perioperative stroke in patients undergoing non-cardiac and non-neurological surgery.~   "
138158|NCT01758913|"~     Pharmacological closure of ductus arteriosus with prostaglandin (PG) inhibitors has been used~     for years. Previous studies indicated that ibuprofen has similar effect on ductal closure as~     indomethacin but has less adverse effects on renal function, cerebral blood flow and~     mesenteric blood flow.1-7 There are, however, very few studies being done specifically on~     extremely low birth weight (ELBW) infant < 1000 g. This group of infants has immature kidney~     and often has poor response to PG inhibitors and has high mortality and morbidity. We~     hypothesized that, in ELBW infants, the ductal and renal response to PG inhibitors may be~     different between indomethacin and ibuprofen.~   "
138159|NCT01758900|"~     Small-balloon enteroscopy is a novel endoscopy system for examination of the deep small~     intestine.Initial reports indicated that CO2 was effective during the colonoscopy~     ,ERCP(endoscopic retrograde cholangiopancreatography) and DBE(double-balloon enteroscopy)~     examination, but it is still uncertain to the SBE(single-balloon enteroscopy) procedure.~   "
138160|NCT01758887|"~     -  Would be there any difference in dopamine synthesis between remitted clinical high risk~          subjects for psychosis and healthy control?~        -  What would happen to dopamine synthesis after antipsychotic discontinuation in clinical~          high risk subjects for psychosis?~        -  What about the dopamine synthesis in recurred clinical high risk subjects for psychosis~          after the discontinuation?~   "
138161|NCT01758874|"~     PAD is caused by an increased flow resistance in atherosclerotic ischemic limbs. The~     investigators hypothesize that reducing blood viscosity (through controlled phlebotomy),~     thereby increasing the deformability of red blood cells, should reduce the flow resistance~     and improve tissue perfusion leading to improved clinical function and a reduction in~     symptoms.~      Preliminary data demonstrates that phlebotomy causes a measurable change in blood viscosity~     as measured by the home-made rheologic method.~      To evaluate the effectiveness of changes in blood viscosity, obtained through controlled~     phlebotomy, as a therapy to improve functional status associated with atherosclerotic~     ischemic limbs in pre-amputation patients.~   "
138162|NCT01758861|"~     Acute kidney injury (AKI) frequently occurs after cardiac surgery using cardiopulmonary~     bypass (CPB). Recombinant human erythropoietin (rHuEPO) is known to provide organ protection~     against ischemia-reperfusion injury through its anti-inflammatory properties. The aim of the~     present study was to investigate the effect of a single preoperative bolus of EPO on the~     incidence of AKI following complex valvular heart surgery in a randomized, controlled and~     double-blind trial.~   "
138163|NCT01758848|"~     Overactive bladder is a syndrome of symptoms. The core symptom is urgency with/without urge~     incontinence, frequency, nocturia. The prevalence of overactive bladder increased with age.~     The elderly is increasing with time, so the people who suffering from overactive bladder is~     also increasing. Research related to overactive bladder in the field of physical therapy is~     remained needed. The purposes of this study are to investigate the application of physical~     therapy to women with overactive bladder, emphasizing on the effect of voluntary muscle~     contraction for urgency inhibition, including the urodynamic study and clinical study.~      There are three stages in this study. In the first stage, we are going to develop a specific~     health-related quality of life questionnaire for urinary incontinence in Taiwan version. One~     hundred and fifty women with urinary incontinence and fifty healthy women without lower~     urinary tract symptom will be recruited in the first year to investigate the reliability and~     validity of the questionnaire. The Short-Form 36, Chinese version, will be used as gold~     standard for validity. Fifty women with urgency will be recruited in the second stage to test~     the effect of muscle active contraction strategies to inhibit detrusor pressure and urgency.~     The three muscle active contraction strategies include pelvic floor muscle strong~     contraction, pelvic floor muscle tonic contraction, and transversus abdominis tonic~     contraction. The outcome variables including detrusor pressure of the urodynamic parameter~     and self-reported urgency score. Simultaneous image record by abdominal ultrasound during the~     urodynamic examination will be used to ensure the accuracy of muscle action. The predictors~     of success of strategy from the result of the second year will be used to stratify the~     patients in the third stage. Eighty women with urgency will be recruited in the final stage~     to examine the clinical effect of strategy for urgency inhibition.~   "
138164|NCT01758835|"~     PRCT multicenter study to evaluate non-operative treatment protocols for treating ER-stress~     negative unimalleolar Weber-B type fibular fractures. Groups are: 1. 3 weeks in a removable~     splint 2. 3 weeks in a cast and 3. 6 weeks in a cast. Follow-up visits at 3, 6 and 12 weeks~     and after 1 and 2 years after injury. In each time X-rays laterally and mortise projections.~     Ankle functional outcome questionnaires: Olerud-Molander score, FAOS RAND-36 and VAS in~     follow up-visits 6 and 12 weeks and 1 and 2 year.~   "
138165|NCT01758822|"~     The purpose of this study is to evaluate the role of endotracheal suction on the occurrence~     of meconium aspiration syndrome in depressed meconium stained babies. Meconium aspiration~     syndrome (MAS) is believed to result from aspiration of meconium and consequent chemical~     pneumonitis. Meconium can be aspirated into the lungs in the womb as well. Meconium in the~     distal airways is not accessible to endotracheal (ET) suction which clears only the windpipe.~     Furthermore there is growing evidence in support of asphyxia-hypoxia-acidosis in the~     causation of lung disease. Moreover, in the absence of a clear role of ET suction in~     depressed meconium stained newborns, critical time could be lost in assessment, intubation~     and ET suction (range: 30 seconds to 1 min) which might delay the definitive step of~     ventilation for resuscitation of such babies that can potentially affect the outcome~     adversely.The utility or futility of endotracheal suction in preventing MAS in depressed~     meconium stained neonates has not been systematically studied and there is inadequate~     information in literature in favor or against this practice.Thus this study is an attempt to~     evaluate the effect of endotracheal suction on the occurrence of MAS in depressed full term~     neonates born through meconium stained amniotic fluid (MSAF).~   "
138166|NCT01758809|"~     The purpose of this study is to evaluate whether pre-emptive local bupivacaine injection is a~     better alternative pain control modality than the conventional intravenous patient controlled~     analgesia.~   "
138167|NCT01758796|"~     The purpose of the study is to find the optimal treatment for ER-Stress positive Weber-B~     unimallaolar ankle fractures.~   "
138168|NCT01758783|"~     Objective: To evaluate the effects of perioperative glutamine supplemented total parenteral~     nutrition support on nutritional status, immunologic function and intestinal permeability of~     patients with chronic radiation intestinal injury.~      Methods: The 40 patients with CRII were randomized into two groups, the standard TPN group~     and glutamine-enriched TPN group. The patients were administered total parenteral nutrition~     for at least four weeks (two weeks pre-operation and two weeks post-operation). The~     nutritional status, immunologic function, plasma concentration of glutamine and intestinal~     permeability were measured at 1 day, 1 week and 2 weeks pre-operation, 3 day, 1 week and 2~     weeks post-operation. Nutrition status was determined the plasma concentrations of~     hemoglobin, albumin, prealbumin, transferrin and triglyceride. Immunologic function were~     measured by the percentages of CD4+T cells and CD8+T cells, the ratio of CD4 +T cells to~     CD8+T cells ( CD4 +/CD8 +) was calculated， and serum IgA, IgM and IgG．The intestinal~     permeability was detected by the urinal ratio of lactulose and mannitol.~   "
138169|NCT01758770|"~     1. To determine the prevalences of osteoporotic fracture in elderly Chinese population.~        2. To determine the prevalences of osteoporosis in elderly Chinese population using QCT BMD~          measurement.~        3. To investigate the difference in the prevalences of osteoporosis between cities and~          urban-rural area in China.~        4. To investigate the association of body composition with osteoporosis~        5. To investigate the prevalence of liver steatosis in China~        6. To investigate the application of QCT fat measurement~   "
138170|NCT01758757|"~     Surgical outcome of vitreous surgery for proliferative diabetic retinopathy (PDR) with~     conventional 20, 23, and 25-gauge vitrectomy were compared.~   "
138171|NCT01758744|"~     An Open Label, Pilot Study Testing the Safety and Efficacy of Inhaled Treprostinil (Tyvaso®)~     in the Treatment of Pulmonary Hypertension (PH) Associated with Chronic Obstructive Pulmonary~     Disease (COPD)~   "
138172|NCT01758731|"~     This is a research study that plans to learn more about the safety and tolerability of an~     investigational drug called Olaparib, in combination with radiation therapy and cetuximab.~      Hypothesis: Intensity modulated radiotherapy with concurrent C225 and Olaparib represents a~     feasible, biologically-based alternative to standard chemoradiation, with acceptable~     toxicity, for treatment of locally-advanced HNSCC in patients having a ≥ 10 pack-year smoking~     history.~   "
138173|NCT01758718|"~     Surgical outcome of entropion associated with Down's syndrome was evaluated. Grading scale of~     superficial punctate keratopathy and score of wearing glasses to correct refractive errors~     were measured.~   "
138174|NCT01758705|"~     The aim of this study is to obtain Venezuelan data of clinical effectiveness, impact in the~     HRQoL, work productivity and activity impairment in patients with psoriasis using adalimumab.~   "
138175|NCT01758692|"~     People with a spinal cord injury (SCI) have limited ability to move and feel sensation below~     the level of the SCI. Doctors and researchers have tests which determine the level of~     function and sensation, this test was developed by the American Spinal Cord Injury~     Association (ASIA) and has been modified over the years to improve use and sensitivity. Most~     recently, the ASIA Injury classification Scale (AIS) was modified in 2011, but this test does~     not include the evaluation of autonomic nervous system (ANS) impairment. However, people with~     SCI do have impairment of the ANS and this may adversely affect how organ systems in the body~     function. Specifically, ANS impairment tends to result in changes in heart rate and blood~     pressure that may relate to the level of the SCI, but this is not fully understood. In this~     investigation we hope to develop simple tests which will allow doctors and scientist the~     ability to measure the amount of ANS impairment to the cardiovascular system, specifically~     the heart. The first part of the study will be to determine the heart rate response to~     several tests (administration of drugs and physical challenges) which will change heart rate.~     These tests will be given to people with and without SCI and the heart rate response will be~     compared between people with and without SCI. The bigger the difference in the heart rate~     response to these test between people with and without SCI the greater degree of ANS~     impairment in the people with SCI. Once this heart rate difference is determined, several~     simple tests (deep breathing, saliva test, Valsalva) will be performed in people with and~     without SCI to again compare the heart rate response. The second part of this study will be~     to determine if the heart rate responses to the first set of tests (administration of drugs~     and physical challenges) can predict the heart rate response to these simple tests (deep~     breathing, saliva test, Valsalva). The aim of this study is to develop a simple battery of~     tests which can be easily used by doctors and scientists to determine the degree of ANS~     impairment to the heart in persons with SCI.~   "
138176|NCT01758679|"~     This clinical trial is designed to provide one kind of modalities for preventing the~     recurrence and metastasis of PLC. If the expected therapeutic efficacy is achieved, it shall~     contribute actively to boosting the therapeutic level of PLC, prolonging its recurrent time~     and enhancing its overall survival. And it may also raise the clinical recognition of this~     technology, promote its clinical applications and generate excellent social reputations and~     economic returns.~   "
138177|NCT01758666|"~     At present, the most effective drugs to osteosarcoma include ADM,DDP,,HD-MTX,IFO and so~     on.The effective rate of single drug was about 30%, and if the chemotherapy contains HD-MTX,~     the survival rate can reach about 60%, so the HD-MTX is the most important component in~     patients of osteosarcoma.~      Studies have shown that, MTX efficacy and adverse reactions were associated with blood~     concentration level and duration, selecting the right time and dose to give CF is the~     critical point.~   "
138178|NCT01758653|"~     The purpose of this biorepository is to collect blood from patients at the time of CO~     poisoning and at follow-up visits months to years later. These samples can be used in the~     future to learn more about how CO damages the heart and brain and whether blood tests could~     predict which patients will have problems after CO poisoning.~   "
138179|NCT01758640|"~     A prospective, randomized, longitudinal, open label, parallel group clinical trial was~     designed to compare the proportions of failure to reach INR target 2.5-3.5 with either: small~     dose warfarin (<5 mg/day) or phenindione (<100 mg/day), in high-risk pregnant and~     non-pregnant patients with bileaflet mechanical heart valve prosthesis.~   "
138180|NCT01758627|"~     In patients with advanced heart failure (HF), systemic congestion is the main indication for~     hospitalization. Recent evidence has highlighted the role of fluid retention in the~     pathogenesis of renal dysfunction and subsequent diuretic resistance. Previous kidney~     disease, diuretic resistance, and progression of renal dysfunction often coexist in patients~     with HF and persistent volume overload. This clinical presentation represents the most~     extreme feature of the cardio-renal syndrome. However, available therapeutic options for this~     ominous condition are scarce and limited. Indeed, there are no data from randomized control~     trials using pharmacological interventions that support the beneficial effect on survival.~     Interestingly, intermittent ultrafiltration has recently emerged as an alternative~     therapeutic option for reducing volume overload in patients with refractory HF. Current~     literature suggests that it has potential advantages over standard medical treatment~     particularly in acute stages of HF. Among ultrafiltration methods, peritoneal dialysis (PD)~     has been preferred as an additional resource for the treatment of advanced congestive heart~     failure (CHF) compared with hemodialysis because it can provide a more physiological and~     continuous ultrafiltration. In fact, several studies showed that use of PD improved clinical~     functional class and hemodynamic parameters and reduced hospitalization rates in patients~     with CHF. Nevertheless, most studies were limited by retrospective analyses of small sample~     size, prospective observational design with no control group, or inclusion of patients with~     end-stage renal failure. Therefore, well-designed prospective randomized controlled studies~     are mandatory to confirm the effects of PD in these patients.~   "
138193|NCT01758458|"~     This phase I/II trial studies the side effects and best way to give laboratory treated~     autologous T cells together with aldesleukin and to see how well it works in treating~     patients with merkel cell carcinoma that has spread from the primary site (place where it~     started) to other places in the body. Biological therapies, such as cellular adoptive~     immunotherapy, may stimulate the immune system in different ways and stop tumor cells from~     growing. Aldesleukin may stimulate the white blood cells to kill tumor cells. Giving cellular~     adoptive immunotherapy with aldesleukin may be a better treatment for metastatic merkel cell~     carcinoma.~   "
138181|NCT01758614|"~     The recently published Carotid Occlusion Surgery Study (COSS) failed to show a benefit of~     extracranial-intracranial (EC-IC) bypass surgery over medical therapy in patients with~     symptomatic hemodynamically significant carotid occlusion. Since then on, different~     controversies have been raised on several aspects including the study population,~     qualifications of surgeons and hemodynamic evaluation.~      In COSS protocol, the primary inclusion population is the patient demonstrating occlusion of~     unilateral ICA while the contralateral ICA less than 50% stenosis. Because of the enrollment~     problems, in the final result report, 18% patients suffered from contralateral ICA stenosis~     more than 50%. As we known, COSS utilized oxygen extraction fraction (OEF) ratio by PET as~     the criterion of hemodynamic evaluation. Bilateral ICAs lesion will disturbed the ratio even~     the identifying the subgroup of patients with hemodynamic insufficiency.~      As an interventional trial, the COSS should ensure the certification for the experienced~     surgeons. While for expanding the number of centers and enhancing recruitment, COSS made some~     concessions on the surgeons training and certification. The 15% postoperative event rate is~     not the best that can be achieved according to recent surgical technical development.~      The cerebral hemodynamic insufficiency has been considered as the primary pathophysiological~     factor for patients with ICA or MCA occlusion. For these patients, antiplatelet therapy is~     not likely to prevent hemodynamic stroke.EC-IC bypass surgery probably will be the possible~     effective therapy.~      These underlying assumptions deserved further exploration and more strict research.So the~     CMOSS study in China is designed to compare the efficacy and safety of EC-IC bypass surgery~     with medical therapy in patients with symptomatic hemodynamically significant carotid~     occlusion.~   "
138182|NCT01758601|"~     The investigators performed this study to evaluate the efficacy of regular ingestion of white~     fish to reduce cardiovascular risk factors in patients with the metabolic syndrome, compared~     to a diet with no fish or seafood at all.~   "
138183|NCT01758588|"~     The purpose of this study is to look at the effectiveness of giving patients who have been~     newly diagnosed with untreated early stage primary myelofibrosis (PMF) a study drug called~     PEGINTRON (also known as pegylated interferon alfa 2b). This intervention will be compared to~     the widely employed watch and wait (best supportive care) approach for early stage PMF, in~     which patients are followed closely and treatment initiated only if the disease progresses.~   "
138184|NCT01758575|"~     Single center, non-randomized, interventional pilot study with feasibility analysis after~     enrollment of 20 patients. Adult patients with advanced solid tumors, for whom standard~     palliative treatment with targeted agents as monotherapy is indicated, including~     antiangiogenic tyrosine kinase inhibitors, EGFR inhibitors, mTOR inhibitors, BRAF inhibitors~     and ipilimumab.After feasibility analysis in the first twenty patients, twenty more patients~     will be included in each of the five drug cohorts. Biopsies will be performed to determine~     possible immunohistochemical and histopathological changes in normal tissue, possible~     immunomodulatory changes as expressed by Tcell phenotyping and cytokine profiling and to~     compare tissue (phospho) proteomic and kinase activity profiles before and during therapy and~     also at the development of toxicity.The main objective of this pilot study is to determine~     the biological impact of treatment with targeted agents at the systemic and local tissue~     level in relation to toxicity.~   "
138185|NCT01758562|"~     Randomized controlled study about the efficacy of the mouth rinse Caphosol in patients with~     allogeneic stem cell transplantation. 85% of the patients receive a severe oral mucositis due~     to their treatment.~      70 patients will be randomized in the intervention (Caphosol) or in the standard~     (state-of-the-art) group. Primary endpoint is the duration of the mucositis, secondary~     endpoints are the occurence of oral mucositis measured with the WHO-scale and the occurence~     of pain measured with the NRS-scale (Numeric Rating Scale).~        -  Trial with medical device~   "
138186|NCT01758549|"~     1. ERCP is a commonly performed endoscopic procedure used to treat stones and blockages of~          the bile duct as well as to manage leaks which occurs following laparoscopic gallbladder~          removal.~        2. Post ERCP pancreatitis (PEP) complicates 5-15% of biliary endoscopic procedures and~          results in considerable suffering and cost.~        3. Patients with acute pancreatitis are treated with fluids.~        4. Our aim is to assess whether prophylactic treatment with aggressive intravenous~          hydration prevents ERCP pancreatitis.~        5. In a blinded fashion patients will be randomized to aggressive intravenous versus~          moderate hydration during and aftere ERCP for standard clinical indications.~      Our hypothesis is that prophylactic treatment with aggressive intravenous hydration protects~     against ERCP pancreatitis.~   "
138187|NCT01758536|"~     The purpose of this study is to determine the efficacy of Huatuo Zaizao Pills in improving~     neural function and life quality in patients with acute ischemic stroke in China.~   "
138188|NCT01758523|"~     This study will examine the safety and potential benefit of the medication dutasteride to~     help men reduce or stop drinking alcohol.~   "
138189|NCT01758510|"~     The purpose of this study is to evaluate the safety of HLA-haplo matched Allogenic Bone~     Marrow Derived stem cells(HYNR-CS-Allo inj), through intrathecal delivery for the treatment~     in patients with amyotrophic lateral sclerosis(ALS).~      This study is an open label, dose up and down study using the 3+3 design to assess the safety~     of HLA-haplo matched Allogenic Bone Marrow Derived stem cells(HYNR-CS-Allo inj)~   "
138190|NCT01758497|"~     Introduction Fascia Iliaca compartment block (FICB) is commonly used to treat pain in~     patients after total hip arthroplasty (THA) despite the lack of RCTs to evaluate the efficacy~     of FICB for this indication. Therefore the objective of this study was to assess the~     analgesic benefit of FICB for post-operative pain management in THA.~      Methods After IRB approval and informed consent, patients having THA at our center in the~     period 2010-2011 were recruited. Eligible patients were adults, ASA physical status I-III,~     and BMI <30) with no contraindication to study procedures. In the PACU, all patients received~     morphine sulfate IVPCA; patients reporting pain > 3 on the NRS-11 despite IVPCA were~     randomized by the method of sealed envelopes to receive US guided injections of 30ml 0.5%~     ropivacaine (FICB) or 30ml 0.9% NaCl (sham block, SB) beneath the fascia iliaca.~      The primary outcome variable was opioid analgesic consumption during the first 24 h~     postoperatively. Secondary outcome measures were pain intensity (NRS-11) and extent of~     sensory blockade.~   "
138191|NCT01758484|"~     This pilot clinical trial studies supportive care for patients with hematological~     malignancies undergoing hematopoietic cell transplant. Supportive care may improve quality of~     life in this patient population.~   "
138192|NCT01758471|"~     This study is aimed to investigate the effect of acarbose on intestinal microbiome and~     incretins, therefore to explore the new pathways or new targets to treat type 2 diabetes.~   "
138194|NCT01758445|"~     The purpose of this study is to look at the rates of acute and long term adverse events of~     postoperative proton radiotherapy for complex loco-regional irradiation in women with~     loco-regionally advanced breast cancer. This study specifically includes longitudinal follow~     up to assess the incidence of cardiac mortality and second malignant neoplasms at 10 and 15~     years following proton therapy(PT).~   "
138196|NCT01758419|"~     Helical tomotherapy nowadays provides the most precise data on radiotherapy (RT) dose~     delivered to each region of the heart in left-sided breast cancer therapy, which allows~     greater sparing of the heart from doses associated with increased complications. However,~     heart disease shows a wide spectrum of pathologies, and multiple risk factors related. The~     damage of the myocytes may lead to not only myocardial perfusion defects, but also in~     functional deterioration, or even in biomarkers. In this study, we will monitor~     cardiovascular (CV) risk factors, metabolism, biomarkers, myocardial perfusion defect~     patterns, and cardiac functional parameters, in order to delineate of RT-related effects and~     clinical impacts.~      Objective: The pilot study aims to investigate the correlation of post-tomotherapy~     cardiovascular effects with myocardial perfusion and cardiac functional studies.~      Methods: The study plans to enroll female breast cancer patients who will undergo local RT~     after their surgery. Patients will receive global risk scoring assessment (Framingham Risk~     Score, FRS), blood sampling for basic biochemistry, inflammatory biomarker, and myocardial~     perfusion image (MPI) at the time points of before and after RT. The results of MPI will be~     analyzed in qualitative visual interpretation of perfusion patterns, and functional~     quantitative data for cardiac functional parameters as well. The patients will be regular~     followed-up in CV OPD. The association between baseline and follow-up MPI, biomarker and~     clinical presentation will be further investigated.~   "
138197|NCT01758406|"~     This study is a prospective, randomized, double blind , controlled trial to assess the~     efficacy of intracoronary transplantation of autologous cardiac stem cells in 50 patients~     with ischemic heart failure.~   "
138198|NCT01758393|"~     This is a randomized, open-label, single-center clinical trial to compare the efficacy and~     safety profile for medium-dose versus high dose glucocorticoid in patients with IgG4-related~     Disease. Patients will be followed for three months to measure the primary outcome and~     secondary outcomes.~   "
138199|NCT01758380|"~     To evaluate vildagliptin as compared to gliclazide, given in combination with metformin in~     Muslim patients with type 2 diabetes fasting during Ramadan.~   "
138200|NCT01758367|"~     Decitabine can up-regulate a series of immune associated proteins, including cancer testis~     antigens (CTA), major histocompatibility complex (MHC), co-stimulatory molecules and adhesion~     molecules, which suggests a potential benefit for a following adoptive T cell therapy. In~     addition, decitabine induce FOXP3 expression in CD4+ T cells and convert CD4+ T cells into T~     regulatory cells(Tregs). As a result, Graft versus host disease(GVHD) can be reduced by~     treatment of decitabine.~   "
138201|NCT01758354|"~     The purpose of this study is to test the feasibility of a newborn screen assay for Pompe~     disease~   "
138202|NCT01758341|"~     Biliary obstruction is importantly influencing quality of life and survival of patients~     suffering from primary or secondary bile duct malignancies. The aim of this retrospective~     data analysis is to evaluate endoscopic radiofrequency ablation (RFA) with the HabibTM~     EndoHBP catheter for the treatment of malignant biliary obstruction. RFA procedures performed~     in Austria so far will be analyzed with regard to feasibility and safety of the technique.~     Therefore, the following parameters will be assessed: (among others) technical failures~     during the RFA procedure, complications during the RFA procedure, hospital stay, adverse~     events during hospital stay and until first clinical control after discharge (an expected~     average of 4 weeks after RFA procedure), 30-day and 90-day mortality. The results of this~     study should help to better understand important aspects of biliary RFA which may positively~     influence future applications of this method.~   "
138203|NCT01758328|"~     The purpose of this study is to test the safety of specialized white cells from the donor at~     different doses. They are called WT1 sensitized T cells. They have been grown in the lab and~     are immunized against a protein. The protein is called the Wilms' tumor protein, or WT1. The~     multiple myeloma cells make and express this protein. The investigators want to learn~     whether the WT1 sensitized T cells will attach to the protein and kill the myeloma cells. The~     investigators want to find out what effects, good and/or bad, it has on the patient and~     multiple myeloma.~   "
138204|NCT01758315|"~     The purpose of the Proactive Reduction of Outpatient Malpractice: Increasing Safety,~     Efficiency, and Satisfaction (PROMISES) project is to assemble a high-level Massachusetts~     consortium to test the impact of powerful quality improvement techniques to accomplish~     innovations and improvements in high risk ambulatory malpractice areas. We will target~     problem-prone processes in 3 areas of identified risk: 1) medication management, 2) test~     ordering and results management 3) follow-up and referral management.~   "
138205|NCT01758302|"~     This one time pilot laboratory study focuses on examining the relationship between different~     types of physical tasks and taste perception of high and low-calorie foods among hungry~     individuals.~   "
138206|NCT01758289|"~     This study was designed to evaluate the effectiveness, safety, and impact on quality of life~     when paricalcitol (Zemplar® intravenous [IV]) is administered in Venezuelan patients on~     hemodialysis who are at risk of developing secondary hyperparathyroidism associated with~     stage V chronic kidney disease.~   "
138207|NCT01758276|"~     This will be a retrospective study. Details on all women who delivered in McGill University~     between 2001-2007 will be retrieved anonymously from the MOND database (McGill University~     Obstetrics and Neonatal database). Women will be divided to 2 groups according to their~     smoking status in pregnancy. Obstetric complications will be recorded in both groups.~   "
138208|NCT01758263|"~     This is a retrospective data analysis of patients with high blood pressure (hypertension) who~     took metoprolol for a minimum of 6 months who then switched to taking nebivolol for a minimum~     of 6 month to treat hypertension. These patients will be identified from a large medical~     claims database. This study tests the hypothesis (alternative, higher or lower) that average~     patient monthly health care administrative cost changes after switching from metoprolol to~     nebivolol.~   "
138222|NCT01758081|"~     The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial~     in 25,875 U.S. men and women investigating whether taking daily dietary supplements of~     vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of~     developing cancer, heart disease, and stroke in people who do not have a prior history of~     these illnesses. This ancillary study is being conducted among participants in VITAL and will~     examine whether vitamin D or omega-3 fatty acids affect risk of infection and plasma hCAP18~     levels.~   "
138209|NCT01758250|"~     In this study, Laser Doppler Flowmetry (LDF), Laser Doppler Imaging (LDI), Orthogonal~     Polarization Spectral Imaging (OPSI), Nail fold video capillaroscopy (NVC) and Optical~     Coherence Tomography (OCT) will be used to assess differences in microvascular function and~     density of oral mucosa and skin in subjects with 1) autoimmune diseases with cutaneous~     involvement: systemic sclerosis (SSc), morphea, dermatomyositis, cutaneous lupus and~     vasculitis, 2) sickle cell disease (SCD) and 3) chronic graft-versus-host disease (GVHD)~     compared to healthy subjects. The microvascular changes will be compared to overall treatment~     response in patients with scleroderma and chronic GVHD as assessments will be made before and~     after the patients start treatment for their diseases and determine if these imaging~     techniques provide valuable and reproducible data when assessing a patient's response to~     treatment for those diseases. In addition, the application of Acoustic Radiation Force~     Impulse (ARFI) in determining cutaneous thickness in patients with SSc, GVHD and morphea will~     be evaluated.~      The investigators hypothesize that the vascular and dermal structures are altered in patients~     with autoimmune disease, SCD and chronic GVHD. In addition, they hypothesize that imaging~     modalities such as LDF, LDI, OCT, NVC, OPSI and ARFI can quantify such structural alterations~     and can be used to 1) detect early disease activity, 2) quantify and assess response to~     therapy and 3) quantify and correlate with overall disease activity.~   "
138210|NCT01758237|"~     To establish the correlation of the location of the Nd:YAG laser peripheral iridotomy to the~     post operative visual symptoms experienced by some patients. The investigators hypothesize~     that fully uncovered laser peripheral iridotomy will produce less significant dysphotopsia,~     due to avoidance of the prismatic effect produced by the tear film than those covered.~   "
138211|NCT01758224|"~     Multiple sclerosis (MS) is a primary disorder of the central nervous system that may affect~     motor pathways and cause muscle weakness. Respiratory complications due to respiratory muscle~     weakness are common in the terminal stages of MS and contribute to mortality in these~     patients. Respiratory muscle weakness may also impair the performance of coughing and~     aspiration, pneumonia, or even acute ventilatory failure may ensue. Functional magnetic~     stimulation (FMS) is a non-invasive method that promotes the contraction of muscles through~     nerve activation. Over the last few years, the study investigators have demonstrated efficacy~     of FMS technology for stimulating respiratory muscles in animal models, able-bodied subjects~     [3] and spinal cord injured (SCI) patients [4]. In this study, the researchers will~     investigate the efficacy of using FMS technique for respiratory muscle conditioning in~     patients with MS. Furthermore, the investigators will also compare expiration related~     outcomes of FMS technique with resistive expiratory muscle training (REMT) methodology.~      Hypotheses~        1. FMS conditioning of the expiratory muscles can generate significant expiratory flows and~          pressures in patients with MS.~        2. FMS conditioning of expiratory muscles is more effective compared to resistive~          expiratory muscle training (REMT) in patients with MS.~   "
138212|NCT01758211|"~     Little is known about the effect of fMRI navigation in the intracranial arteriovenous~     malformation surgery. The investigators aim to perform a multicenter prospective randomized~     single -blind clinical trial to assess the effect and safety of fMRI navigation in the brain~     arteriovenous malformation surgery.~   "
138213|NCT01758198|"~     The purpose of this study is to compare the clinical efficacy including joint damage~     progression and safety of Abatacept plus Methotrexate (MTX) to placebo plus MTX.~   "
138214|NCT01758185|"~     The objective of this study was to evaluate the safety and immunogenicity of one inactivated~     split influenza vaccine, a primarily Chinese-marketed trivalent vaccine.~   "
138215|NCT01758172|"~     From postoperative patients having undergone pancreaticoduodenectomy;~        1. To compare the hemodynamic parameters from the patient administrated 5% HA and 6%~          Voluven~        2. To assess the efficacy of the treatment as regards the clinical outcomes and laboratory~          parameters of the patient~        3. To compare the safety of the 2 intravenous colloids in the patient population~   "
138216|NCT01758159|"~     Complementary feeding diet in developing countries cannot meet iron requirements of infants~     and young children. Iron supplementation is mostly used to treat iron deficiency whereas iron~     fortification is cost-effective strategy to control iron deficiency in developing countries.~     However, a recent study showed that iron fortification imposed negative impact on gut~     microbiota by increasing colonization of gut pathogen over beneficial bacteria. Gut~     microbiota plays essential roles in nutrient absorption, vitamin synthesis; intestinal~     mucosal barrier function and pathogen displacement. Iron is essential for growth and~     virulence of most gut pathogens and so iron supplementation might have similar negative~     impact on gut microbiota composition. Therefore, nutrition interventions would not be~     justified by assessing micronutrient status alone ignoring any possible deterioration of gut~     microbiota. The investigators hypothesized that optimizing the nutrient intake from locally~     available foods according to complementary feeding recommendation (CFR) can improve the iron~     status of these children while maintaining healthy gut microbiota composition.~      A randomized, placebo-controlled, community-based, intervention trial will be conducted in~     Ayeyarwady division of Myanmar where childhood undernutrition is prevalent. The aim of this~     study is to compare the effect of optimized CFR to iron supplementation on iron status and~     gut microbiota composition of 1-2years old Myanmar children. Cluster randomization will be~     done at the village level to randomly allocate the villages into CFR or non-CFR villages.~     Individual randomization will be done to randomly assign each child into iron or placebo~     syrup so that individual children will receive one of 4 treatment groups (CFR, Fe, CFR + Fe,~     and Control) for a period of 24 weeks. Based on expected between-groups difference of~     hemoglobin 5g/L, at 80% power, 5% level of significance, 15% drop-out rate; after taking into~     account the cluster effect; required sample will be 109 per group (total = 436). A sub-sample~     of 15 children from each group will be randomly selected for gut microbiota assessment (total~     = 60). Blood samples for iron status and stool samples for gut microbiota assessment will be~     collected at baseline and endline. Anthropometric measurements, usual intake of iron and~     infectious disease morbidity will also be assessed.~   "
138217|NCT01758146|"~     To see the impact of obesity on the efficacy of adjuvant endocrine therapy with aromatase~     inhibitors in postmenopausal patients with early breast cancer in terms of:~      i) Locoregional recurrence ii) Distant metastases iii) Disease-free survival iv) Overall~     survival~   "
138218|NCT01758133|"~     The aim of this study is to determine whether medical clown activity enables relaxation of~     mothers of premature infants, and as a result increases their breast milk production.~   "
138219|NCT01758120|"~     Treatment of prednisone plus cyclophosphamide may be superior to treatment of prednisone~     alone in patients with advanced-stage IgA nephropathy.~   "
138220|NCT01758107|"~     Study safety of longterm immunosuppressive protocol with Sirolimus plus Prednisolone, and~     Calcineurin inhibitor withdrawal.~   "
138221|NCT01758094|"~     The aim of the present study was to demonstrate the RBP4 levels, association of RBP4 with~     insulin resistance and influence of testosterone treatment on this cytokine in patients with~     idiopathic hypogonadotropic hypogonadism.~   "
138261|NCT01757561|"~     the purpose of this study is to investigate whether propofol and sevoflurane have difference~     effect on cerebral oxygenation .~   "
138223|NCT01758068|"~     The skin of newborn infants is immature and ineffective as a barrier. Preterm skin exhibits~     even more vulnerability to the environment due to poor self regulatory heat mechanisms,~     paucity of fatty tissue and its thinness. Most preterm babies lose up to 13% of their weight~     as water loss from their skin during the first week of life. Many strategies have been~     utilized by neonatologists to decrease this water loss. Edible coconut oil application on the~     skin acts as a non permeable barrier and can help in achieving this. Hence the investigators~     decided to undertake this study to objectively assess the reduction in water loss from skin~     after oil application.~   "
138224|NCT01758055|"~     The purpose of this study is evaluating the safety of endobronchial transplantation of~     autologous mesenchymal stem cells derived bone marrow in patients with emphysema.~   "
138225|NCT01758042|"~     The main purpose of this study is to examine the outcome of a combined bone marrow and kidney~     transplant from a partially matched related (haploidentical or haplo) donor. This is a~     pilot study, you are being asked to participate because you have a blood disorder and kidney~     disease. The aim of the combined transplant is to treat both your underlying blood disorder~     and kidney disease. We expect to have about 10 people participate in this study.~      Additionally, because the same person who is donating the kidney will also be donating the~     bone marrow, there may be a smaller chance of kidney rejection and less need for long-term~     use of anti-rejection drugs.~      Traditionally, very strong cancer treatment drugs (chemotherapy) and radiation are used to~     prepare a subject's body for bone marrow transplant. This is associated with a high risk for~     serious complications, even in subjects without kidney disease. This therapy can be toxic to~     the liver, lungs, mucous membranes, and intestines. Additionally, it is believed that~     standard therapy may be associated with a higher risk of a complication called graft versus~     host disease (GVHD) where the new donor cells attack the recipient's normal body. Recently,~     less intense chemotherapy and radiation regimens have been employed (these are called reduced~     intensity regimens) which cause less injury and GVHD to patients, and thus, have allowed~     older and less healthy patients to undergo bone marrow transplant. In this study, a reduced~     intensity regimen of chemotherapy and radiation will be used with the intent of producing~     fewer toxicities than standard therapy.~      Typical therapy following a standard kidney transplant includes multiple lifelong medications~     that aim to prevent the recipient's body from attacking or rejecting the donated kidney.~     These are called immunosuppressant drugs and they work by quieting the recipient's immune~     system to allow the donated kidney to function properly. One goal in our study is to decrease~     the duration you will need to be on immunosuppressant drugs following your kidney transplant~     as the bone marrow transplant will provide you with the donor's immune system which should~     not attack the donor kidney.~   "
138226|NCT01758029|"~     This study will be conducted as a prospective, single-center (multiple clinics), single-arm~     open phase IV study.~      the study will follow hypogonadal patients, and aimed to confirm the hypothesis that~     testosterone undecanoate improves the patient satisfaction and quality of life, with parallel~     improvement in their spouses's quality of life and satisfaction. Each patient/spouse will~     serve as his own control.~   "
138227|NCT01758016|"~     Pregnancies of patients with Diabetes are associated with increase adverse pregnancy outcome~     . The risk for vascular complications including: Intra uterine growth restriction (20%),~     hypertension (31%), preeclampsia (15%), eclampsia and placental abruption are significantly~     greater than those in background populations. The risk of developing vascular complications~     in diabetes pregnancies although is correlated with the severity and length of the disease is~     not fully understood. Enhanced oxidation has been suggested to be the underlying abnormality~     responsible for some of the complications of diabetes.~      Haptoglobin (Hp) is an abundant plasma glycoprotein produced in the liver. The best~     understood function of Hp is to bind free hemoglobin (Hb) released from red blood cells.~     Extracorpuscular Hb is a potent Fenton reagent.capable of of inflicting oxidative tissue~     damage. Hp binds to Hb and serves to inhibit the oxidative potential of Hb by preventing the~     release of heme iron.~      The haptoglobin (Hp) gene at chromosomal locus 16q22 is polymorphic, with two common alleles~     denoted 1 and 2. the prevalence of Hp 1-1, Hp 1-2 and Hp 2-2 genotypes is approximately 16%,~     48% and 36%, respectively. In the western world. A total of five independent longitudinal~     studies have demonstrated that DM individuals with Hp 2-2 genotype have a two to five-fold~     increased risk of CVD as compared to DM individuals without the Hp 2-2 genotype We sought to~     determine whether HP genotype plays important role in development of vascular complications~     in pregastational pregnancies. and whether Hp genotype 2-2 is a risk factor for developing~     gestational diabetes (GDM)~   "
138228|NCT01758003|"~     The primary aim of this research is to examine physical activity in a healthy population aged~     over 40 years old.~      Subsidiary aims of this research are:~        1. To establish normative values for physical activity levels, exercise capacity, quality~          of life and readiness to change physical activity behaviour (stages of change,~          self-efficacy, decisional balance and processes of change) in a healthy population~          age-matched to a population with bronchiectasis.~        2. To explore physical activity levels, exercise capacity and quality of life in a healthy~          population age-matched to a population with bronchiectasis.~        3. To explore readiness to change physical activity behaviour (stages of change,~          self-efficacy, processes of change and decisional balance) in a healthy population~          compared to a population with bronchiectasis.~   "
138229|NCT01757990|"~     The aim of the present investigation was to evaluate the effect of stevioside and~     rebaudioside on several variables related to caries development. Two approaches were~     performed: an in vitro evaluation of the growth of a culture of mutans streptococci and in~     vivo randomized study on the effect of a single rinse containing stevioside and rebaudioside~     on plaque-pH.~   "
138230|NCT01757977|"~     The investigators have performed a number of studies on novel airway devices. In this~     randomized controlled trial he investigators would like to compare the performance of a new~     double-lumen endotracheal tube incorporating internal camera (Vivasight DL) with a standard~     double lumen tube.~   "
138231|NCT01757964|"~     In this study, the investigators want to see if Bacteriotherapy (also referred to as stool~     transplantation) improves the symptoms and decreases inflammation in children with~     Inflammatory Bowel Disease (IBD). Examples of IBD are Crohn's Disease and Ulcerative Colitis.~     Additionally, researchers want to learn whether this experimental therapy delays the need for~     starting additional medications to treat pediatric IBD.~   "
138232|NCT01757951|"~     A one third of all ankle fractures are bi- or trimalleolar. Traditionally these fractures are~     treated by both medial and lateral osteosynthesis, sometimes accompanied by osteosynthesis of~     the posterior malleolus. There is significant evidence that fractures of the lateral~     malleolus can be treated conservatively if the medial side is stable. However, there isn't a~     single study comparing standard bi- or trimalleolar fixation with only medial side~     osteosynthesis and postoperative immobilization with a cast.~   "
138262|NCT01757548|"~     The purpose of this study is to determine whether high ligation of spermatic vein by open~     operation and microsurgery for patients with are effective in the treatment of varicocele and~     to determine which surgical option is better.~   "
138233|NCT01757938|"~     Adult male circumcision (AMC) can reduce the incidence of HIV transmission by 40-60% in~     sub-Saharan Africa (SSA). The World Health Organisation and Joint United Nations Programme on~     HIV/AIDS advocate AMC for the reduction of HIV transmission in heterosexual men, and~     feasibility studies have demonstrated that AMC programmes can be effectively delivered to~     hyperendemic communities, such as those in SSA. Despite these recommendations, the potential~     effects of AMC have been attenuated by low uptake, with only 5% of all men who could benefit~     undergoing surgery to date. Traditional, time-consuming methods of AMC that require formal~     surgical training limit uptake in low-income countries. Training and implementation by~     non-physician health providers is dampened by a need to perform approximately 100 procedures~     to achieve satisfactory operative time and adverse effect rates. The investigators performed~     a randomised controlled effectiveness study to compare the shang ring (SR) with standard~     forceps-guided (FG)-AMC in a publicly funded regional referral hospital with a locally~     trained surgeon in Mbarara, western Uganda.~   "
138234|NCT01757925|"~     Recently, researchers have been interested in the use of game play, mechanics and psychology~     for health-related engagement and behavior change. While initial studies have shown some~     increases in health knowledge and/or behavior through gaming, there remains concern that the~     vehicle for change is associated with a perceived sedentary behavior (6).~      More recently, commercially available gaming devices are able to directly promote physical~     activity through a new set of kinetic controllers added to the gaming experience. UHG plans~     to evaluate the most recent of these kinetic controller technologies in the context of a~     second iteration of JOIN (described above) to be implemented among a pilot group of~     overweight and/or obese children whose BMI percentile is above the 85th.~      This study will evaluate the effect of a commercial controller-free Exercise Gaming and~     Entertainment Experience (EGEE) on physical activity levels in the context of a weight~     management program in approximately 70 children ages 6 to12. The study will compare the~     differences in physical activity levels over 16 weeks in two groups of children.~   "
138235|NCT01757912|"~     The endotracheal tube secures free airway in patients undergoing surgical procedures or~     mechanical ventilation. The extraluminal airway needs to be sealed by a cuff. The cuff needs~     to be adequately inflated with air. The cuff pressure should be between 20 and 30 cm H2O. A~     cuff pressure in excess of the target range is associated with a risk of tracheal injury,~     whereas a cuff pressure below the lower limit includes a risk of micro-aspiration of~     subglottic secretions, with risk of subsequent ventilator-associated pneumonia. It is unknown~     whether the cuff pressure changes following changes in body position of the patient. The~     objective of this study is to investigate to which extent - if any - cuff pressures change~     after body position changes of the patient.~   "
138236|NCT01757899|"~     The purpose of this study is to investigate the effects of prolonged low-dose~     methylprednisolone infusion on pulmonary function (LIS and ventilation-free days), extra~     pulmonary organ function (PMODS score), inflammatory markers - RCP (Reactive C Protein), IL6~     (Interleukine 6), TNFα (Tumor Necrosis Factor), IL8 (Interleukine 8), IL10 (Interleukine 10)~     and length of Pediatric Intensive Care Unit (PICU) stay in early ALI/ARDS in children.~   "
138237|NCT01757886|"~     The prognostic value of inflammatory markers in acute coronary syndrome has been extensively~     demonstrated, however it is still unknown whether there is an association between circulating~     and local (thrombus) inflammatory molecules, and the subset of molecules that provide better~     prognostic information in patients with ST-elevation acute coronary syndrome.~   "
138238|NCT01757873|"~     This study will compare Z160 and placebo in patients with Postherpetic Neuralgia for safety~     and efficacy for a period of 6 weeks.~   "
138239|NCT01757860|"~     Study Phase: Phase 1~      Primary Objective:~      • To evaluate the safety and tolerability of single ascending oral doses of CARD-024 in~     healthy subjects~      Secondary Objectives:~        -  To evaluate the pharmacokinetic (PK) profile of CARD-024 following ascending single oral~          doses of CARD-024~        -  To evaluate the effect of CARD-024 on cardiovascular indices including plasma renin~          activity (PRA) and blood pressure (BP), biological markers of activity, following~          ascending single oral doses of CARD-024~   "
138240|NCT01757847|"~     This study proposes to compare a brief Acceptance and Commitment Therapy (ACT) group~     intervention to an active control group in a sample of 154 overweight or obese binge eating~     Veterans who have completed the VA's national behavioral weight management program (MOVE!).~     This study anticipates that the ACT intervention will reduce binge eating and distress while~     improving functioning and maintenance of weight loss.~   "
138241|NCT01757834|"~     Shear wave ultrasound elastography is a new technique of finding the softness or hardness in~     tissue by applying a push generated by the machine. This technique will help in diagnosing~     malignancy in the thyroid gland without biopsy and avoiding biopsy in noncancerous nodules.~   "
138242|NCT01757821|"~     The goal of stroke rehabilitation is to restore function to the weak side of the body.~     However, this is often a difficult task to accomplish due to not only to damage from the~     stroke, but from increased excitability in the non-stroke side of the brain that inhibits the~     stroke side from functioning optimally. Repetitive transcranial magnetic stimulation (rTMS)~     is a non-invasive form of brain stimulation that can enhance excitability in the stroke side~     when applied at a low-frequency on the non-stroke side. By inhibiting the inhibition (i.e.~     disinhibition), rTMS promotes adaptive brain reorganization following stroke. Previous~     research in healthy individuals demonstrates enhanced effects of low-frequency rTMS when it~     is preceded by high-frequency (excitatory) rTMS stimulation known as priming. Our lab~     previously demonstrated the safety of 6-Hz priming with low-frequency rTMS in both adults and~     children with chronic stroke. However, it is currently unknown whether or not the addition of~     priming stimulation to low-frequency rTMS enhances excitability in the stroke hemisphere. Our~     study will examine three rTMS interventions in twelve adults (at least 18 years): 1.) 10~     minutes of real priming followed by 10 minutes of low-frequency rTMS, 2.) 10 minutes of fake~     priming followed by 10 minutes of low-frequency rTMS, 3.) 20 minutes of low-frequency rTMS~     only. Participants will receive all three interventions in randomized order. Each week,~     participants will complete two pretest and 3 posttest sessions consisting of behavioral~     measures of weak upper extremity function and cortical excitability in addition to receiving~     one rTMS intervention. Following each week of testing and treatment, subjects will take a one~     week rest break before crossing-over to receive another intervention. We hypothesize the~     following: 1.) Primed rTMS will result in significantly reduced inhibition and significantly~     increased excitation on the stroke side vs. fake primed rTMS or low-frequency rTMS given~     alone and 2.) Primed rTMS will result in greater improvements of paretic hand function. This~     study is innovative in that it intends to compare primed and unprimed rTMS in the stroke~     brain that could acknowledge a more effective delivery method of rTMS to potentially yield~     greater rehabilitative outcomes.~   "
138263|NCT01757535|"~     This study will enroll approximately 460 subjects, aged 55 or older, with a diagnosis of de~     novo AML (Acute Myeloid Leukemia) or AML secondary to prior myelodysplastic disease or~     chronic myelomonocytic leukemia (CMML), and who have achieved first Complete remission (CR)/~     Complete remission with incomplete blood count recovery (CRi) following induction with or~     without consolidation chemotherapy. Subjects who have previously achieved CR/CRi with a~     hypomethylating agent will be excluded from the study.~   "
138243|NCT01757808|"~     The purpose of this study is to assess the safety of ranolazine in people with pulmonary~     arterial hypertension (PAH) and who are receiving 1 or more background PAH therapies:~     ambrisentan, sildenafil,tadalafil, epoprostenol, treprostinil (IV, SC, inhaled), or iloprost.~     The primary objective is:~        -  To estimate the effect of ranolazine administration on acute hemodynamics.~        -  To assess safety of ranolazine acutely over 6 hrs in the catheterization lab and after~          12 weeks of therapy~        -  To assess changes in right ventricular function after 12 weeks of therapy.~   "
138244|NCT01757795|"~     Phase I study in health volunteers to assess the safety, tolerability and pharmacokinetics of~     escalating single doses and multiple doses of SP-8203~   "
138245|NCT01757782|"~     The purpose of this study is to to study the role of oral Sildenafil in Persistent Pulmonary~     Hypertension of Newborn (PPHN) secondary to Meconium Aspiration Syndrome (MAS) in newborns~     and to study risk factors of MAS developing into PPHN.~   "
138246|NCT01757769|"~     The purpose of this study is to confirm in a larger population in Europe the effectiveness~     and safety observed with silodosin in previous clinical trials.~   "
138247|NCT01757756|"~     This study is designed to assess the safety, tolerability and pharmacokinetics of multiple~     oral 200-mg doses of Pf-05175157 administered twice daily for 14 days in healthy overweight~     and obese subjects.~   "
138248|NCT01757743|"~     This project will evaluate fluid balance and oedema formation in children with the same~     congenital heart disease (Atrial Septal Defect) who will either go through heart surgery with~     the use of Cardio Pulmonary Bypass and hypothermia or through interventional catheterization.~     The investigators will measure interstitial colloid osmotic pressure, distribution of~     proteins and cytokines. The study hypothesis is that Oedema developed during heart surgery~     is caused by reduced colloid osmotic pressure gradient through the capillary membrane.~   "
138249|NCT01757730|"~     Magnetic resonance elastography is a novel non-invasive MRI technique to obtain stiffness of~     soft tissues such as liver, heart, kidneys, etc. In this imaging technique a person is laid~     in an MR scanner and a paddle (plastic drum) is put on the area of interest to send sound~     vibration via a speaker placed outside the scan room which is connecting plastic drum via a~     plastic tube. These vibrations are scanned using MRI to estimate the stiffness of soft~     tissues such as liver, heart, kidneys, breast etc.~   "
138250|NCT01757717|"~     The purpose of this study is to see if using a form of imaging during surgery helps the~     doctors to guide the placement of radiation catheters more accurately.~      This method, called image-guided surgical navigation may allow the doctors to deliver~     radiation to the tumor that the patient needs and decrease the amount of radiation delivered~     to the nearby areas.~   "
138251|NCT01757704|"~     The Lund de-airing technique is employed for cardiac de-airing in open left heart surgery. It~     consists of two main elements namely, opening of both pleura after the patient is on CPB~     (cardiopulmonary bypass)and disconnection of the ventilator before opening the left heart to~     ensure bilateral pulmonary collapse and a staged filling of the heart at termination of the~     CPB. The aim of this study is to analyze in a randomized manner two groups of patients to~     establish if one or both components are of primary importance for the effectiveness of the~     de-airing technique.~   "
138252|NCT01757691|"~     To evaluate the efficacy and safety of fingolimod 0.5mg versus placebo in patients with~     suspected acute demyelinating optic neuritis (ADON) receiving standard steroid treatment~   "
138253|NCT01757678|"~     To determine the diagnostic performance of FFRCT by coronary computed tomographic angiography~     (cCTA), as compared to cCTA alone, for non-invasive determination of the presence of a~     hemodynamically significant coronary lesion, using direct measurement of fractional flow~     reserve (FFR) during cardiac catheterization as a reference standard.~   "
138254|NCT01757665|"~     The objective of this trial is to confirm that the modifications to tissue processing, valve~     sterilization and packaging do not raise any new questions of safety and effectiveness in~     subjects who require replacement of their native or prosthetic aortic or mitral valve.~   "
138255|NCT01757639|"~     This phase I trial studies the side effects and best dose of ipilimumab and how well it works~     in treating patients with high-risk myelodysplastic syndrome or acute myeloid leukemia that~     has come back or no longer responds to treatment. Monoclonal antibodies, such as ipilimumab,~     may interfere with the ability of cancer cells to grow and spread.~   "
138256|NCT01757626|"~     The purpose of this study is to find out if an antibody called Humanized 3F8 (Hu3F8) combined~     with granulocyte- macrophage colony stimulating factor (GM-CSF) is safe for treating~     neuroblastoma.~   "
138257|NCT01757613|"~     In this three-armed dose-finding trial 3 AK 3012 topical formulations shall be investigated~     with respect to safety and efficacy in order to identify the optimal concentration in the~     topical formulation.~      The main objective of the trial is to determine the optimal concentration of the active agent~     in the topical formulation as quantified by the change of the number of skin alterations in~     pre-defined areas in a time period from inclusion in the trial until the end of treatment (3~     months) or prior complete healing.~   "
138258|NCT01757600|"~     To evaluate the correlations between anatomical and functional changes studied with~     microperimetry (MPM) and spectral-domain OCT (SD-OCT) in patients after successful repair of~     idiopathic macular hole (MH).~   "
138259|NCT01757587|"~     The main objective is to show that the addition of Galvus versus placebo in patients with~     type 2 diabetes treated with metformin (at the maximum tolerated dose) and basal insulin~     properly titrated, allows a greater proportion of patients achieving an HbA1c below 7%.~      The primary efficacy endpoint was the percentage of patients responding to treatment (HbA1c~     less than 7%) after 3 months of treatment with Galvus or placebo~   "
138260|NCT01757574|"~     The objectives of this study are to determine the safety, tolerability and preliminary~     efficacy of alemtuzumab for infusion for the treatment of CIDP. Eligible subjects will be~     treated with alemtuzumab at the beginning of the study and then followed for three years.~     During the three year period, subjects will under go monthly safety evaluations consisting of~     blood and urine testing, symptom surveys and examination. Detailed neurological testing~     including nerve conduction testing, Rasch-built Overall Disability Scale (CIDP/RODS) and~     Overall Neuropathy Limitations Scale (ONLS) assessments will be performed every six months~     for three years.~      The study will also investigate and compare the responsiveness of the outcome measures being~     used.~   "
138264|NCT01757522|"~     Acute respiratory distress syndrome (ARDS) and mechanical ventilation can lead to right~     ventricular dysfunction and ultimately right ventricular failure by increasing pulmonary~     vascular resistances and pressure load. This can be prevented by modifying ventilator~     settings, using vasopressors or inotropes or even by prone positionning.But to do so, right~     ventricular dysfonction has to be detected. Echocardiography has emerged as a first line tool~     to diagnose right heart failure. Recently, strain analysis showed promising results to detect~     early right ventricle abnormalities in other settings such as pulmonary hypertension or~     scleroderma. We therefore decided to determine whether 2D strain could help detect early~     right ventricular dysfunction in ARDS.~   "
138265|NCT01757509|"~     The aim of this study is to investigate if set dancing is beneficial and feasible for those~     with Parkinson's disease in Ireland. The hypothesis of this feasibility study are that:~        -  Participants will be able to partake fully in the intervention without reporting adverse~          events.~        -  There will be evidence of gains in functional exercise tolerance, balance, motor~          performance and quality of life in those with Parkinson's disease who participate in~          eight weeks of set dancing classes compared to a control group.~   "
138266|NCT01757496|"~     RSV bronchiolitis in children is still associated with significant morbidity and mortality.~     RSV infection results in increased mucus production, edema and inflammation at the lower~     airways and impaired mucociliary clearance. Infants and children under the age of 1 year are~     particularly vulnerable to complications such as atelectasis and secondary bacterial~     infection. These children often need non-invasive or invasive ventilation. Atelectasis is~     common in these children because of smaller airways and decreased cough strength. There is~     still much uncertainty about the treatment of RSV. Treatment consists primarily of supportive~     therapy such as tube feeding and additional respiratory support if necessary. There is also~     limited evidence about the use of nebulizers with beta-agonists and/or hypertonic saline.~      The cough assist is a mechanical in- and exsufflator used primarily in patients with~     neuromuscular diseases to augment cough capacity. In these patients, it was demonstrated that~     the use of assisted cough resulted in a significant decrease in the number of respiratory~     infections. Moreover, there is evidence that when used in the case of an acute respiratory~     deterioration such a massive atelectasis, the atelectasis can be corrected and intubation can~     be avoided. The aim of this study is to investigate if the use of the CoughAssist device in~     children with RSV bronchiolitis is associated with a better respiratory outcome.~   "
138267|NCT01757483|"~     This study is designed to evaluate the effectiveness of the current ticagrelor risk~     minimisation strategy in Canada through a prescriber knowledge and understanding (KAU) survey~     of selected important identified safety concerns (i.e., bleeding, dyspnea and drug~     interactions) and ASA dosage.~   "
138268|NCT01757470|"~     Effectiveness of risk minimisation interventions for vandetanib in Canada~   "
138269|NCT01757457|"~     Intracoronary abciximab administration during primary percutaneous coronary intervention~     (pPCI) could offer clinical advantages over the intravenous route. The aim of this study was~     to assess whether abciximab administration route could influence its anti-inflammatory~     effects. 87 consecutive STEMI patients candidate to pPCI were randomized to receive an~     intracoronary or intravenous abciximab bolus. The primary endpoint was the extent of~     inflammation, measured by C-reactive protein (CRP), VCAM-1 and ICAM-1 levels.~   "
138270|NCT01757444|"~     In 2012, it has announced the availability of the new ventilator (BiPAP- A40), which could~     offer potential advantages over fixed level pressure support, in particular, in patients with~     obesity hypoventilation syndrome (OHS). One of the key benefits of the BiPAP A40 is an~     innovative ventilation mode called AVAPS-AE, which automatically maintains airway patency~     while delivering the correct level of ventilation each user requires, whatever their body~     position or sleep stage. AVAPS-AE mode is also aimed to help the clinicians during the~     initial titration of therapy, while providing long term comfort and assuring therapy~     compliance. However, studies on the physiologic and clinical effects have not yet been~     performed. The aim of our singled-blind randomised multicentre controlled trial is to~     prospectively investigate the effects of BiPAP with the spontaneous/timed (S/T) or the~     AVAPS-AE ventilation mode over 8 weeks on sleep quality, ventilation pattern, gas exchange,~     symptoms, body composition, level of physical activity and health-related quality of life in~     OHS patients.~   "
138271|NCT01757431|"~     Protocol is intended to characterize the overall safety and tolerability of eculizumab in~     this population.~   "
138272|NCT01757418|"~     The purpose of this study is to determine whether intravenous immune globulin is safe and~     effective in the acute treatment of pain crises in sickle cell disease.~      Funding Source: Food and Drug Administration (FDA), Office of Orphan Products Development~     (OOPD)~   "
138273|NCT01757405|"~     The purpose of the study is to determine the efficacy and safety of rFVIIa BI as part of a~     six-month on-demand treatment regimen in hemophilia A or B subjects with inhibitors.~   "
138274|NCT01757392|"~     The primary objective of this study is to determine the safety of Candin® (Candida albicans~     Skin Test Antigen) at a 0.3 ml dose level at up to 6 monthly injections for treating common~     warts (Verruca vulgaris).~   "
138275|NCT01757379|"~     The purpose of the study is to evaluate the bioavailability of acetate, propionate and~     butyrate in healthy humans using a stable isotope technology.~      In addition the level of acetate, propionate and butyrate production from inulin will be~     determined using the principle of isotope dilution.~   "
138276|NCT01757366|"~     Safety and Efficacy of Ginsenoside Rg3 in Combination with First-line Chemotherapy in~     Advanced Gastric Cancer.The purpose of this study is to assess the safety of Ginsenoside Rg3~     in advanced gastric cancer, and whether it improves the efficacy of first-line chemotherapy.~   "
138277|NCT01757353|"~     The goal of this research study is to compare three harm reduction approaches for at-risk~     college student drinkers. One approach provides generic risk-related information after an~     initial interview/questionnaire assessment session. A second approach uses an established~     motivational interviewing framework (Brief Alcohol Screening and Intervention for College~     Students; BASICS) that provides personalized feedback in a follow-up session. A third~     approach also uses BASICS, but tests the utility of a personality-informed module for this~     approach that is informed by the social investment hypothesis.~   "
138278|NCT01757340|"~     The purpose of this study is to determine whether consuming additional leucine during calorie~     restriction induced weight loss has beneficial or harmful effects on multi-organ (liver,~     muscle, adipose tissue) insulin sensitivity, colonocyte proliferation rates, the gut~     microbiome, muscle mass and function, and bone mineral density in obese, postmenopausal~     women.~   "
138279|NCT01757327|"~     This randomized phase II trial studies the effects of erismodegib (LDE225) on disseminated~     tumor cells (DTCs) in patients with stage III-III estrogen receptor (ER)-negative and human~     epidermal growth factor receptor 2 (HER2)-negative breast cancer. The presence of DTCs after~     completing treatment for breast cancer may be linked to recurrence of the disease. LDE225 may~     eliminate DTCs in bone marrow and reduce the risk of recurrence.~   "
138280|NCT01757314|"~     When surgery is performed under general anesthesia, a catheter is placed in a vein to~     administer drugs and saline. During major operations, an additional catheter is placed in an~     artery in order to measure the blood pressure closely and withdraw blood samples at frequent~     intervals for various laboratory tests. This arterial catheter is usually placed by feeling~     the patient's artery at the wrist and inserting the guide-needle in a blind fashion. This~     procedure, at times, leads to delays and failures due to an inability to feel the arterial~     pulsation well either due to the patients' anatomy or the anesthetic effect. This study will~     determine whether training Anesthesiology Residents in the use of ultrasound technology and~     its application in identifying an artery can prevent the problems associated with the~     conventional palpation technique. Our finding will lead to better and safer anesthetic~     management of patients presenting for a major surgical procedure. Furthermore, the finding~     will help us in introducing the education and training of ultrasound-guided arterial catheter~     placement in our Residency Program.~      The investigators propose to follow anesthesia residents over a course of 3 years assessing~     their skill level for both palpation and ultrasound technique.~   "
138281|NCT01757301|"~     Pain is the most common presenting symptom in medical outpatients, and depression and anxiety~     are the two most common mental disorders. All three conditions are often inadequately treated~     and result in substantial disability, reduced health-related quality of life, and increased~     health care costs and utilization. Additionally, pain, anxiety, and depression (PAD) are~     frequently comorbid with one another and have reciprocal negative effects on treatment~     response and additive effects on adverse health outcomes. The PAD triad is especially~     burdensome in Veterans, with their high prevalence of chronic pain, depression, PTSD, and~     other anxiety disorders. The Comprehensive vs. Assisted Management of Mood and Physical~     Symptoms (CAMMPS) study is a randomized comparative effectiveness trial designed to test the~     relative effectiveness of a lower-resource vs. a higher-resource enhancement of usual primary~     care in the management of Veterans suffering from with pain plus comorbid anxiety and/or~     depression.~   "
138282|NCT01757288|"~     The investigators propose this phase I/II study to use weekly Nab-Paclitaxel (Abraxane) and~     carboplatin with concurrent radiation in local-regionally advanced lung cancer. There are no~     published human studies combining Nab-Paclitaxel (Abraxane) with radiation. The investigators~     will first confirm the tolerated dose (TD) of concurrent Nab-Paclitaxel (Abraxane) at~     50mg/m2, and then will begin enrolling patients into the phase II component using either~     Nab-Paclitaxel (Abraxane) at the TD with carboplatin concurrent with daily radiation or~     paclitaxel with with carboplatin concurrent with daily radiation.~   "
138283|NCT01757275|"~     To describe the rate of clinically significant rebleeding during 72 hours continuous i.v.~     infusion of high dose esomeprazole Na in patients in China with primary successful endoscopic~     haemostatic therapy of a bleeding peptic ulcer, with cimetidine i.v. in~   "
138284|NCT01757262|"~     Study in Vietnamese Patients with Coronary Heart Disease to investigate safety and P2Y12~     Receptor Inhibition Effects of Ticagrelor and Clopidogrel~   "
138285|NCT01757249|"~     Endometriosis is a hormone dependent disease of women, in which endometrial tissue (the cells~     which line the uterus or womb) are found outside the uterus (womb). Some women with~     endometriosis may be infertile. However, treatments for infertility such as in vitro~     fertilization (IVF) or IVF with intracytoplasmic sperm injection (IVF-ICSI) appear to be less~     successful, i.e. the pregnancy rates are lower, for women with endometriosis than for women~     who may be infertile for other reasons.~      Since endometriosis is hormone dependent, it has been suggested that suppressing the activity~     of hormones produced by the ovaries (which affect endometrial growth) may inactivate~     endometriosis and so increase the chances of pregnancy. Recently it has been proposed that~     taking the oral contraceptive pill (OCP) for 6 to 8 weeks before IVF or IVF-ICSI treatment~     could be used for this purpose.~      For our study, which is a randomised controlled trial, women with endometriosis meeting the~     study criteria planning to undergo IVF or IVF-ICSI at the Oxford Fertility Unit will be~     recruited. Study participants will be randomised into 2 arms: experimental group and control~     group. The experimental group will be instructed to complete an 8 week course of OCP before~     beginning standard IVF treatment. The control group do not take any study medication before~     beginning standard IVF treatment. The IVF or IVF-ICSI treatment for both groups is not~     altered by participation in the study.~      The aim of the study will be to determine if pretreatment with OCP improves IVF or IVF-ICSI~     success rates, such as live birth and pregnancy rates, in patients who suffer from~     endometriosis. The study is funded by the Oxford Fertility Unit.~   "
138286|NCT01757236|"~     The purpose of this study is to evaluate the efficacy of oral linezolid-rifampin combination~     therapy (over 4 or 6 weeks) versus the standard of care in the treatment of Gram-positive~     prosthetic hip joint infection with a one-stage surgical treatment.~   "
138287|NCT01757223|"~     The proposed Phase I/II clinical trial will be used to determine the safety and toxicity of~     direct administration of the vector AdVEGF-All6A+ to the ischemic myocardium and to generate~     preliminary evidence regarding whether direct administration of AdVEGF-All6A+ to the ischemic~     myocardium will induce growth of collateral blood vessels and improve cardiac function. This~     is a three-part, multinational/multi-center, placebo controlled study.~   "
138349|NCT01756404|"~     The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the~     drug) and pharmacodynamics (ie, how the drug affects the body) of increasing doses of~     canagliflozin (JNJ-28431754) in healthy obese volunteers.~   "
138288|NCT01757210|"~     Aprepitant was approved in 2003. The drug works to lessen the amount of nausea and vomiting~     that cancer patients experience after treatment. Aprepitant has been well-studied in adults,~     but not in children. Data from adult studies has shown aprepitant to be safe. It has also~     been shown to be effective in lessening the amount of nausea and vomiting that adult patients~     experience. Because aprepitant has been shown to be safe and effective, the investigators~     have been using it in pediatric patients at this hospital as standard of care. The~     investigators will be surveying patients already receiving aprepitant for prevention of~     chemotherapy-induced nausea and vomiting to determine the amount of nausea and vomiting they~     experience. The investigators will also be surveying these patients to determine what their~     appetite is like and if they experience any disruptions in activities of daily living. The~     investigators are also going to be assessing any side effects these patients experience from~     receiving aprepitant.~   "
138289|NCT01757197|"~     The purpose of this study is to determine if Tocilizumab is a safe and effective treatment~     for steroid-refractory acute graft versus host disease.~   "
138290|NCT01757184|"~     This Phase 3 study will evaluate the efficacy and safety of 1 mg/kg IV infusions of SBC-102~     (sebelipase alfa) administered every other week in patients with late onset lysosomal acid~     lipase (LAL) deficiency (cholesteryl ester storage disease).~      Late onset LAL Deficiency is an underappreciated cause of cirrhosis, liver failure and~     dyslipidemia. There is currently no standard treatment for LAL Deficiency other than~     supportive care. Enzyme replacement therapy (ERT) may be a potential new treatment option for~     LAL Deficiency patients.~   "
138291|NCT01757171|"~     Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks, as is the standard~     administration dose and schedule. This application is a non-labeled indication for~     cabazitaxel and will inform future drug development in gastroesophageal malignancies, where~     docetaxel remains an approved first line agent, but is not routinely used due to excessive~     toxicity and marginal efficacy.~      At the conclusion of this study, we hope to demonstrate activity of single agent cabazitaxel~     in refractory gastric cancer, with preferential activity in one or more gastric cancer~     subtypes~   "
138292|NCT01757158|"~     The primary curative treatment of lung cancer patients is surgery, chemotherapy and/or~     radiation therapy (either or all depending on the extent of disease). Surgical resection~     usually requires removal of a lobe of the lung (lobectomy). There are, however, some patients~     who are unable to have a lobectomy. There are several reasons why a patient should not have a~     lobectomy including prior operations in the same area of the lung or poor lung functions.~     Sub-lobe operations (less than a full lobectomy), are alternatives for these patients. Types~     of sub-lobe operations include wedge resection or segmentectomy.~      However, a randomized trial in early stage lung cancer patients that compared lobectomy~     versus wedge resection showed worse local control of cancer with wedge resection. Therefore,~     localized disease wedge resection is considered an inadequate operation. This inadequacy can~     be compensated if radiation seeds are added to the site of wedge resection. Iodine-125~     (I-125) is the most commonly used radiation seed for this purpose. I-125, however,~     unfortunately has a relatively long half life (time taken for activity to become half) of 2~     months. Therefore, the patient is technically 'radioactive' for an average of 6 months to 1~     year. This can seriously compromise quality of life.~      Cesium-131 is another radiation seed that may more effectively treat lung cancer patients.~     Cs-131 has been previously used in prostate cancer successfully. Cs-131 has similar energy to~     I-125 but has a much shorter half life (9days as compared to 60 days for I-125). Patients who~     receive Cs-131 radiation seeds are expected to be radioactive for 30 days (1 month) as~     compared to 180 days (6 months) with I-125. The objective of this study is the use Cs-131~     radiation seeds in lung cancer patients who are planning to undergo a wedge resection for~     localized disease and follow the patients for cancer control and toxicity. These results will~     be compared to pre-existing data for I-125 treatment outcomes in lung cancer patients who~     have had a wedge resection for localized disease.~   "
138293|NCT01757145|"~     The purpose of this study is to determine whether Eltrombopag may shorten time to platelet~     engraftment after allogeneic cord blood transplantation.~   "
138294|NCT01757132|"~     The objective of the PAS-01 study is to assess the safety of the intraocular as measured by~     the cumulative incidence of patients who within 5 years after implantation experience~     persistent vision-impairing corneal edema (corneal edema leading to persistent loss of best~     corrected distance visual acuity >2 lines from pre-surgery baseline level).~      The study will test the null hypothesis that the percentage of patients who experience~     persistent vision-impairing corneal edema is >17% against the alternative that the percentage~     is <17%. The null hypothesis will be rejected if the upper bound of the two-sided 95%~     confidence integral for the observed percentage is <17%.~   "
138295|NCT01757119|"~     The purpose of this study is to investigate the pharmacokinetics of serum iron (the amount of~     iron in blood) after single oral administration of 2 tablets of L0008 80 mg (as ferrous~     sulphate) in women with iron deficiency anaemia.~   "
138296|NCT01757106|"~     Purpose of this study is to test whether xenon application during off-pump-coronary artery~     bypass (OPCAB)-surgery is safe and feasible.~   "
138297|NCT01757093|"~     The purpose of this study is to compare the oxygen consumption and energy expenditure during~     the spontaneous breathing trial.~   "
138298|NCT01757080|"~     OBJECTIVE: To analyze the influence of lipid control during a cardiorespiratory exercise test~     in two subgroups. DESIGN: Parallel trial study. PARTICIPANTS: The sample consisted of 40~     elderly people, male and female, divided into two groups: 20 hypertensive (G1; 68.50 ±5.85~     years) and 20 diabetic-hypertensive (G2; 68.95 ±6.79 years). MEASUREMENTS: Nutritional~     status; glucose and lipid controls - postprandial glucose (PPG), triglycerides (TG), total~     cholesterol (TC), low density lipoprotein (LDL-C), very low density lipoprotein (VLDL-C),~     high density lipoprotein (HDL-C); blood pressure, and cardiorespiratory performance. The~     significance level was set at p<0.05.~   "
138299|NCT01757067|"~     Premature ventricular contractions (PVC) are a very common irregular heart beat (arrhythmias)~     even in patients without heart disease. Frequent PVCs are thought to occur in about 1-4% of~     the general population. Many patients with PVCs complain about skipping of their heart~     (palpitations), shortness of breath and feeling tired. In some patients PVCs may also result~     in weakening of the heart muscle (heart failure), which might be reversible with suppression~     of the PVCs.~   "
138300|NCT01757054|"~     The main hypothesis of this study is that there will be a significant increase of~     Lactobacillus rhamnosus GG (LGG) and Bifidobacterium lactis (BB-12) in the stool of healthy~     humans following daily consumption of a probiotic supplement containing these specific~     strains of probiotic bacteria.~   "
138369|NCT01756144|"~     When there is a bone defect, bone transport is used to bridge the defect. Frequently, the~     bone in the docking site (where the transported bone comes together) doesn't heal.~      The objective is to study the effectivity of rhBmp-2 (inductos) to stimulate bone healing, in~     order to find new techniques to treat non-union of long bones.~      The method of the study is a randomized controlled trial, to compare rhBMP-2 and autologous~     bone grafting in stimulating bone healing in the docking site.~   "
138301|NCT01757041|"~     Sub-Saharan Africa (sSA) has the highest regional rates of perinatal mortality worldwide.~     Group B Streptococcus (GBS) has been identified as a leading cause of early onset neonatal~     sepsis (EOS, in <7 days of life) in sSA. In other regions, maternal carriage is associated~     with early onset neonatal sepsis, but in addition, other adverse perinatal outcomes~     (stillbirths, early neonatal death, low birth weight and prematurity). Robust data on~     maternal GBS carriage in sSA and its burden on adverse perinatal outcomes are lacking, with~     important consequences for public health interventions.~      Through investigation of maternal carriage and perinatal outcomes at three different sites:~     rural, semi-rural and urban, this study will provide a comprehensive description of the~     burden of GBS in coastal Kenya, informing public health policy and driving forward~     interventions. Risk factors for maternal colonisation and invasive neonatal disease will be~     assessed, including through retrospective immunological investigation of cord blood in~     neonates subsequently identified as having invasive GBS disease or other adverse perinatal~     outcomes, compared to those without.~      GBS isolates from maternal colonisation will be typed (sero-typing and molecular analysis),~     and these isolates will be compared to existing archived neonatal isolates from investigation~     of neonatal sepsis in KDH (Kilifi District Hospital). This is important so that we know the~     prevalent sub-types causing neonatal disease in Kenya, those which are carried by mothers,~     and therefore whether maternal GBS carriage correlates with a high risk of perinatal disease.~     GBS vaccines in development are type-specific and this will inform their use in sSA.~      Stillbirths will also be investigated, in individual cases, through additional detailed~     microbiological and other laboratory investigations to make an assessment of the contribution~     of GBS to stillbirths in Kenya.~   "
138302|NCT01757028|"~     Improving maternal and infant mortality are key priorities in Kenya and internationally. This~     study aims to establish a hospital-based surveillance system for pregnant women so that the~     contribution of risk factors (HIV and other infections, maternal nutrition, sepsis, malaria~     and anaemia) to maternal and infant morbidity and mortality can be accurately assessed. All~     mothers who are admitted to Kilifi District Hospital will be invited to enrol in the study.~     Routine clinical data from maternal admissions for delivery will be systematically collected~     using a standardised admissions procedure. Analysis will be carried out for the risk factor~     effects of HIV, maternal nutrition, malaria infection, bacterial infection, and anaemia on~     maternal and infant outcomes after adjusting for other factors (mode of delivery, age, and~     parity etc). Subsequent morbidity and survival of mothers and infants, and the later~     consequences to children's health will be monitored through the Kilifi epi-DSS. Samples for~     research purposes will be collected for detailed future studies of particular pathogens and~     risk factors, such as malaria parasite strain, bacterial species and HIV-induced~     immunological impairment. This will be the first prospective study in sub-Saharan Africa~     (sSA) to assess the effect of these risk factors on both maternal and infant health together,~     and that considers both short and long term outcomes. Information generated by the study will~     be used by the maternity department in a rolling audit that will help improve care. The study~     will therefore improve care of new mothers and infants attending the Kilifi District Hospital~     as well as informing health planning so that future interventions for maternal and child~     health are targeted more effectively.~   "
138303|NCT01757015|"~     This study is to evaluate if add-on treatment with inhaled NVA237 (50 µg) once daily (o.d.)~     via single-dose dry-powder inhaler (SDDPI) further improves lung function and health status~     and is well tolerated compared to placebo in symptomatic COPD patients with moderate to~     severe airflow limitation who are already receiving maintenance therapy with inhaled~     fixed-dose-combination of salmeterol/fluticasone propionate (50/500 µg) twice daily (b.i.d.)~     via multi-dose dry powder inhaler (MDDPI).~   "
138304|NCT01757002|"~     The purpose of this study is to evaluate the Puff City web-based behavioral intervention of~     asthma management program in a clinical setting. This study also examines and evaluates the~     cost and efficiency of patient eligibility determination methods, patient recruitment, study~     monitoring (compliance with study regimen, participant retention and follow-up), and the~     collection of clinical endpoints.~   "
138305|NCT01756989|"~     The purpose of this study is to determine whether initial local irradiation with topotecan~     and following oral antiangiogenic drugs, thalidomide, celecoxib and etoposide are effective~     in the treatment of pediatric diffuse brainstem tumor.~   "
138306|NCT01756976|"~     This study is intended to provide additional performance data of the OrthoPAT Advance in~     routine orthopedic surgery.~   "
138307|NCT01756963|"~     In addition to a genetic susceptibility, the immune system and the intestinal microbiota,~     diet is hypothesized to be an important factor in the onset and progression of Inflammatory~     Bowel Diseases (IBD). Further insight in factors affecting disease activity may contribute to~     targeted interventions improving disease burden and healthcare costs for these patients.~     However, well-designed studies exploring the role of diet in the development of exacerbations~     are hardly available.~      The investigators hypothesize that differences in dietary patterns affects the intestinal~     microbiota composition and thereby contributes to the development of exacerbations in IBD.~      Furthermore, a subgroup of patients suffers from malnutrition, although the exact prevalence~     is unknown since simple noninvasive screening tools have not been validated for IBD. The~     investigators hypothesize that malnutrition is frequently present in IBD patients and~     associated with dietary intake and disease characteristics.~   "
138308|NCT01756950|"~     The purpose of this study is to assess in healthy subjects the safety, tolerability,~     pharmacokinetics and immunogenicity of single escalating doses of CR8020, a monoclonal~     antibody against influenza A viruses.~   "
138309|NCT01756937|"~     Efficacy and safety of Imotun capsule in osteoarthritis of the knee~   "
138310|NCT01756924|"~     To determine if oral antibiotic treatment with CEM-102 and Rifampin is as effective and safe~     as the standard of care antibiotic therapy for the treatment of hip and knee prosthetic joint~     or spacer infections~   "
138311|NCT01756911|"~     Evaluation of the Multilayer Flow Modulator (MFM) for Endovascular Thoracoabdominal Aneurysm~     Repair.~      The objectives of the study is to determine the efficacy, safety and performance of the MFM~     and its delivery system in patients at high surgical risk presenting with a type II, III~     thoracoabdominal aneurysm, below the left subclavian and above the iliac bifurcation,~     according to the Crawford classification.~   "
138312|NCT01756898|"~     The purpose of this research study is to gather scientific information about the~     effectiveness of the study drug, ASB17061 capsules, when compared to placebo in adult~     subjects with atopic dermatitis.~   "
138370|NCT01756131|"~     A single dose escalation study to determine the safety, tolerability, and pharmacokinetic~     profile of intramuscular and subcutaneous injections of GSK1265744 long acting parenteral~     (LAP) in healthy subjects. This study consists of a screening visit, a single injection, and~     follow-up evaluations for a minimum of 12 weeks following the injection.~   "
138313|NCT01756885|"~     Upwards of 33-50% of cancer patients who smoked prior to diagnosis continue to smoke~     following diagnosis and treatment. With medical advances in cancer care yielding a growing~     constituency of cancer survivors, addressing nicotine dependence in this population is a~     priority. While PHS guidelines recommend acute treatment durations with approved medications~     for tobacco use, extending the duration of treatment beyond the standard treatment duration~     significantly increases quit rates, reduces the risk for a relapse, and promotes recovery to~     abstinence following a lapse. Varenicline may be particularly effective for cancer patients~     given the drug's beneficial effects on affect and cognition. In this trial, 374 cancer~     patients will be randomized to standard varenicline treatment (12 weeks active + 12 weeks~     placebo) or extended varenicline treatment (24 weeks active). The investigators hypothesize~     that 1) Extended varenicline therapy will increase 24- and 52-week biochemically-confirmed~     abstinence versus standard varenicline treatment, 2) Quality of life will be rated higher in~     the extended therapy group versus the standard therapy group, and there will be no~     significant differences between groups in terms of severe side effects, and 3) Improved~     affect and reduced cognitive impairment will mediate the effect of extended therapy on quit~     rates.~   "
138314|NCT01756872|"~     The purpose of this study is to find out more about tests used to estimate the number of eggs~     a woman has remaining in her ovaries (her 'ovarian reserve'). It is thought that women who~     have a greater number of eggs or ovarian reserve may have a better chance of successful in~     vitro Fertilisation (IVF) treatment than those who have a smaller number of eggs. Accurately~     predicting the likely outcomes of IVF would be of great benefit for counselling patients~     before they go through expensive and demanding treatments such as IVF and IVF with~     Intracytoplasmic sperm injection (IVFICSI).~      Over the past two decades, many endocrine and ultrasound markers have been designed and are~     now used as indicators of ovarian reserve. A number of screening tests are utilized to~     measure these markers, either by ultrasound scanning techniques or taking blood samples.~     However it is not yet known which, if any, best predict the outcome of IVF treatment. We~     would like to investigate these various measures of ovarian reserve to determine which are~     most accurate, particularly for predicting live birth rates, as up to now only poor to~     moderate quality evidence has been available for this outcome.~      This will be a prospective cohort study of 300 women who already intend to undergo~     IVF/IVF-ICSI treatment. Study participants will have one extra blood sample and ultrasound~     examination, for the purposes of measuring markers of their ovarian reserve, at the start of~     their IVF/IVFICSI treatment cycle. No other interventions will be required and their~     treatment cycle will not be affected by their participation in the study.~   "
138315|NCT01756859|"~     Death from chronic liver disease has doubled in the UK over the last decade. This is largely~     due to the rise in liver disease from excess alcohol consumption, obesity related fatty liver~     disease and hepatitis B & C infections. The current 'liver tests' only identify liver injury~     when the damage is at an advanced stage. They neither estimate the degree of injury~     accurately nor help judge prognosis. The complications from chronic liver disease result~     mainly from raised pressures within the liver. We currently measure this pressure by passing~     a long catheter through the jugular vein in the neck into the liver. This invasive test does~     carry a small yet significant risk of complications and is not available outside specialised~     liver centres. Raised pressure within the liver is also associated with changes in the~     microorganisms within the gut. This leads to increased infective complications among patients~     with liver cirrhosis.~      We aim to noninvasively measure the pressures within the liver using Magnetic Resonance~     Imaging (MRI). We will recruit 49 patients with chronic liver disease who have had liver~     pressure measurements as part of their routine clinical assessment. The participants will~     attend the Biomedical Research Unit and the MR Centre for a single 2hour visit. We will also~     collect blood, urine and stool samples from them.~      The diagnostic accuracy of the quantitative MRI techniques will be validated against the~     pressures obtained via the invasive test. The quantitative MRI techniques will also~     correlated with biomarkers of liver injury obtained from blood and urine samples. The stool~     sample obtained will be used to characterise the gut microorganisms in these patients.~   "
138316|NCT01756846|"~     Aim of this study is to quantify the impact of the use of the HEART risk score on patient~     outcome and on costs in patients with chest pain presenting at the emergency room, as~     compared to not using the score.~   "
138317|NCT01756833|"~     The primary aim of this study is to determine if doxycycline (100 mg bid) will inhibit (by at~     least 40%) the increase in greatest transverse diameter of small abdominal aortic aneurysms~     (3.5-5.0 cm in men, 3.5-4.5 cm in women) over a 24-month period of observation in comparison~     to a placebo-treated control group.~   "
138318|NCT01756820|"~     The purpose of this study is to determine whether Single-portal Endoscopic Carpal Tunnel~     Release (Agee technique, SmartRelease™, MicroAire) and mini-open technique (Knifelight®,~     Stryker) are equally effective and safe surgical options for the treatment of primary Carpal~     Tunnel Syndrome.~   "
138319|NCT01756807|"~     Evaluation of Endothelial ProGenitor Cell Capture Sirolimus-Eluting Stent by Optical~     Coherence Tomography: the COMBO Stent angiographic extension Study (EGO-COMBO angiographic~     extension Study)~   "
138320|NCT01756794|"~     The purpose of this study is to validate a strategy of identification of patients for early~     liver transplantation in severe alcoholic hepatitis. In this setting, short-term survival is~     very low (approx. 25% at 6 months) and a pilot study has suggested (mathurin et al. N Engl J~     Med 2011) that liver transplantation may be an option in very carefully selected patients who~     did not respond to medical treatment. This selection process deserves to be confirmed in a~     population of greater size. We hypothesized that patients selected with this process would~     have a same alcohol relapse rate after liver transplantation than patients transplanted for~     alcoholic cirrhosis and selected using a 6-month sobriety period~   "
138321|NCT01756781|"~     This is a drug-drug interaction study to compare the pharmacokinetics of a 2 mg oral dose of~     midazolam in adult healthy women of non-childbearing potential when administered alone and~     when administered along with 8 daily 125 mg doses of PD-0332991. Volunteers will be~     randomized to one of two sequences. Volunteers in sequence 1 will receive midazolam alone in~     treatment period 1, followed by multiple dose PD-0332991 and midazolam in treatment period 2.~     Volunteers randomized to sequence 2 will receive multiple dose PD-0332991 and midazolam in~     treatment period 1, and following a washout period of no less than 14 days they will receive~     midazolam alone in treatment period 2.~   "
138322|NCT01756768|"~     This will be an open-label, single-center study to evaluate the mass-balance and~     pharmacokinetics of PD-0332991 in approximately 6 healthy male subjects receiving a single~     oral 125 mg dose of PD-0332991 containing approximately 100 microcuries of [14C]-PD-0332991.~     Subjects will be checked in to the research unit from approximately 12 hours prior to dosing~     and remain in house until greater than 90% of the administered radioactivity is collected~     from bodily excreta or until less than 1% of the administered radioactivity is recovered from~     excreta on consecutive days. This study will investigate the extent of involvement of the~     renal and hepatic systems in the elimination of PD-0332991 and will seek to identify the~     compound's major metabolites.~   "
138323|NCT01756755|"~     Despite maintaining adequate mean arterial pressure and central venous oxygen saturation, the~     mortality is still high in severe sepsis and septic shock. Previous studies have demonstrated~     that derangements in microvascular flow play a role in sepsis-induced multiple organ~     dysfunction and death. Lipopolysaccharide (LPS) or endotoxin is a specific ligand for~     Toll-like receptor 4 (TLR4), it can induce the following reactions including excessive immune~     and inflammatory responses , oxidative stress , capillary leakage, endothelial damage,~     impaired arteriolar and venular vasoregulation, and activation of the coagulation cascade 8.~     Subsequently, these reactions can lead to microcirculatory dysfunction. Polymyxin B adsorber~     hemoperfusion (PMX) have been proved to reduce mortality of severe sepsis and septic shock.~     Since 1994 to 2007, more than 60,000 patients have received this treatment. In a systematic~     review, the results show that PMX therapy was associated with significantly lower mortality~     risk (risk ratio, 0.53; 95% CI, 0.43 to 0.65). In a prospective, multicenter, randomized~     controlled trial (Early Use of Polymyxin B Hemoperfusion in Abdominal Sepsis [EUPHAS]), the~     results show that SOFA scores improved in the polymyxin B group, and 28-day mortality was 32%~     in the polymyxin B group and 53% in the conventional therapy group.~      The investigators hypothesize that polymyxin B hemoperfusion can decrease blood endotoxin~     level and reduce endotoxin-related microcirculatory dysfunction. The purpose of this~     prospective, multicenter, randomized, controlled, open study is to investigate the effect of~     polymyxin B hemoperfusion on the sublingual microcirculation in patient with proven or~     suspected gram-negative bacteria severe sepsis and septic shock. The mean arterial pressure,~     dose of vasopressors and inotropics, SOFA score, PaO2/FiO2 ratio, and 28-day mortality will~     be investigated.~   "
138324|NCT01756742|"~     Pleural effusion and the complexity of diagnosis and treatment make planning and delivering~     care challenging. Respiratory physiotherapy is recommended, and should be applied during the~     first weeks of treatment.The aim of the present study is to demonstrate the effectiveness of~     a respiratory physiotherapy protocol in patients with Pleural Effusion who attended a~     University Hospital.~   "
138325|NCT01756729|"~     This is a non-randomized, concurrent control study, designed to confirm that the efficacy of~     the NovoTTF-100A System in patients with recurrent GBM treated in a real life settings~     following approval is comparable to that of BSC chemotherapy patients. The device is a~     portable, battery operated device that was approved for the treatment of adult patients (22~     years of age or older) with histologically-confirmed glioblastoma multiforme (GBM), following~     histologically- or radiologically-confirmed recurrence in the supra-tentorial region of the~     brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and~     is intended as an alternative to standard medical therapy for GBM after surgical and~     radiation options have been exhausted.~   "
138326|NCT01756716|"~     The purpose of this study is to evaluate pharmacodynamics, safety, tolerability and~     pharmacokinetics of MT-3995 in Type II Diabetic Nephropathy Subjects with Albuminuria and~     Moderately Decreased GFR~   "
138327|NCT01756703|"~     The purpose of this study is to evaluate pharmacodynamics, safety, tolerability and~     pharmacokinetics of MT-3995 in Type II Diabetic Nephropathy Subjects with Albuminuria~   "
138328|NCT01756690|"~     A certain molecule floating in the blood may represent a risk of lung injury after a~     transfusion. We are determining whether detection of this molecule on a simple blood clotting~     test will predict the development of lung injury due to transfusion in bleeding patients with~     chronic liver disease.~   "
138329|NCT01756664|"~     - The use of sunscreen on the first day after fractional ablative skin resurfacing may reduce~     the risk of post-inflammatory hyperpigmentation~   "
138330|NCT01756651|"~     The purpose of this study is to assess the safety and efficacy of intranasally-administrated~     fentanyl pectin spray (Lazanda®)given to decrease the pain during cystoscopy (the passage of~     a telescopic instrument into the bladder for purpose of diagnosing the cause of blood in the~     urine, urinary complaints or any other problems with the urinary bladder). The current~     standard practice is to use Lidocaine jelly (a local anesthetic) given through the urethra to~     lubricate and decrease local pain. In this study, an additional medicine (Lazanda®) is used~     to reduce pain that occurs during and after the above procedure.~   "
138331|NCT01756638|"~     The purpose of this study is to investigate safety and efficacy of abiraterone in~     participants with metastatic castration-resistant prostate cancer (mCRPC) and who have not~     received prior chemotherapy (treatment of disease, usually cancer, by chemical agents).~   "
138332|NCT01756625|"~     PREMIUM is an observational pharmaco-epidemiologic, transversal, multi-centric, prospective~     cohort study and with independent investigators. The purpose is to compare PFS in real life~     with PFS clinical trials and to determine factors impacting efficacy and compliance to~     cetuximab treatment in first line K-ras wild-type (wt) metastatic colorectal cancer.~   "
138333|NCT01756612|"~     This prospective, multicenter, observational study will evaluate the impact of comorbidity~     factors on the hemoglobin level in participants with chronic kidney disease who are not on~     dialysis and initiated on treatment with methoxy polyethylene glycol-epoetin beta (Mircera).~     Data will be collected for 9 months after initiation of methoxy polyethylene glycol-epoetin~     beta treatment.~   "
138350|NCT01756391|"~     Asthma is a disease that affects more than 12% of Americans under the age of 18 for over 14~     million missed school days per year, and is the number one cause of school absences in~     America. Elementary school children spend 6 to 10 hours a day in school, and most of that~     time is spent in one classroom. The goals of this project are to provide an understanding of~     exposure risk factors specific to the classroom. This is critical, because the classroom~     environment could potentially be considered as an effective target for prevention of~     inner-city asthma morbidity by reducing exposures to many symptomatic children through an~     intervention in the school classrooms.~   "
138351|NCT01756378|"~     we tested the effect of adding the mobilization with movement to the traditional physical~     therapy program on pain, ROM and functional disability in patients with knee OA.~      study hypothesis: there will be no significant difference between traditional physical~     therapy program and the mobilization with movement plus the traditional physical therapy~     program on pain, ROM and functional disability in patients with knee OA~   "
138423|NCT01755429|"~     This protocol is intended to formally collect data on the treatment of aHUS with eculizumab~     in Japanese patients.~   "
138334|NCT01756599|"~     Regular advances in cancer treatment have dramatically improved the prognosis of children and~     adolescents with acute leukemia (AL), raising with a great acuity the problem of the late~     physical side effects, social integration, quality of life of the patients and their family~     as well as identification of the determinants of these outcomes. Large nationwide and~     international cohorts developed in general population (I4C, EPIC ELF…) are restricted to the~     study of childhood cancers occurrence. In addition, the national registries (French,~     European) of childhood cancers are designed to evaluate incidence and mortality, but not to~     produce individual detailed data on the follow-up and outcome of these children. Answering~     these questions supposes a comprehensive multidisciplinary approach resting on prospective~     cohorts of cancer survivors, specifically exploring the outcome of these children. These~     cohorts allow to identify prognostic factors of the health condition and social integration,~     and to propose adapted strategies of follow-up. The Childhood Cancer Survivor Study (CCSS),~     which remains the most important study, only concerns the North-American populations and~     rests on a self-reported follow-up assessment. In France, the LEA study, initiated in 2004~     could answer some of these questions, but the representativeness and the size of the~     population (study initially limited to two areas PACA-Corsica and Lorraine) remain~     insufficient to study uncommon events. Similar approaches are conducted in Europe trough the~     broad collaborative Pancare network, to which the LEA program is associated.~   "
138335|NCT01756586|"~     Dexamethasone has shown to prolong upper extremity blocks. No one ha studied its effect on~     lower extremity blocks. The study would evaluate that point.~   "
138336|NCT01756573|"~     Effect of dexamethasone on prolonging upper extremity block is well known. But it not known~     if the effect comes from its local effect on the nerves or from its general analgesic effect.~     In this study we will compare the systemic effect to its local effect to find out if there is~     a difference or not.~   "
138337|NCT01756560|"~     Anterior cruciate ligament reapair is a painful procedure. Single shot femoral and sciatic~     nerve block only last 12-16 hrs. Since dexamethasone prolongs brachial plexus block, using it~     in lower extremity blocks will prolong the analgesia to provide better outpatient pain relief~     after surgery at home.~   "
138338|NCT01756547|"~     Study to assess the efficacy and safety of oral potassium citrate on the Prevention of~     nephrocalcinosis in extreme premature: a clinical trial, randomized, double-blind placebo~     controlled trial.~   "
138339|NCT01756534|"~     This single-blind prospective randomized study was designed to assess the efficacy and safety~     of the use of Surgicel® compared to the use of conventional surgical procedures (ligatures~     and bipolar electrocautery alone) to achieve hemostasis in thyroid surgery~   "
138340|NCT01756521|"~     The purpose of this study is to evaluate effect of moxifloxacin on QT/QTc interval in healthy~     male subjects. Moxifloxacin is a positive control drug used in QT study. In this study,~     moxifloxacin 400mg and 800mg will be used, to get information on effect of moxifloxacin on~     QT/QTc interval.~   "
138341|NCT01756508|"~     Study of eculizumab ability to correct the reperfusion injury of the kidney allograft.~   "
138342|NCT01756495|"~     This will be a double-blind, 4-period, randomized, cross-over study conducted in healthy~     adult subjects. The purpose of this study is to characterize the effect of orally~     administered losmapimod on the electrocardiogram (ECG) parameters with a focus on cardiac~     repolarization as measured by the corrected QT interval (QTc) duration, compared with placebo~     and moxifloxacin. Moxifloxacin (Avelox) is a drug with a known potential to create a mild QTc~     interval prolongation; therefore, it will serve as a positive control to validate the ability~     of this study to detect a change in the QTc interval. All subjects will participate in 4~     study periods separated by a minimum washout period of 5 days. Each subject will receive one~     of 4 regimens (A = Losmapimod 7.5 milligram [mg] Twice daily [BID] x 5 days, B = Losmapimod~     20 mg Once daily [QD] x 5 days, C = moxifloxacin 400 mg on Day 5, D = Losmapimod matched~     placebo and moxifloxacin placebo x 5 days) in each of the 4 planned study periods in a~     randomized, cross-over fashion. Subjects will be assigned to one of four treatment sequences~     following a Williams design (ABDC, BCAD, CDBA, DACB). Follow-up visit will occur 10 to 14~     days after end of Period 4~   "
138343|NCT01756482|"~     This study is to evaluate the antiviral effect of GS-5806 in healthy adults infected with a~     strain of Respiratory Syncytial Virus.~   "
138344|NCT01756469|"~     The main study objective is to investigate whether female sex workers (FSWs) at drop-in~     centers in Mombasa, Kenya, who report harmful or hazardous alcohol intake and participate in~     a brief alcohol intervention (vs. those who participate in a nutrition intervention in the~     control group), will reduce their alcohol use and incidence of STIs, HIV, and sexual~     violence, as well as increase their condom use.~   "
138345|NCT01756456|"~     This study is aimed at assessing the safety and the efficacy of two dose regimens of~     recombinant human nerve growth factor (rhNGF) eye drops solution compared to vehicle for~     inducing a complete healing of stage 2 (persistent epithelial defect) and 3 (corneal ulcer)~     neurotrophic keratitis~   "
138346|NCT01756443|"~     Regional anaesthesia has become the cornerstone of multimodal analgesia. With the advent of~     ultrasound guided nerve blocks regional anaesthesia has achieved both greater efficacy and a~     better safety profile as the injection of local anaesthetic is performed under direct vision.~     This has allowed a reduction of the amount of local anaesthetic injected as compared to~     peripheral nerve stimulation technique . Blockade of sciatic nerve combined with saphenous~     nerve provides anaesthesia and analgesia for ankle/foot surgeries. Various combinations of~     local anaesthetics have been used to provide optimal blockade . A mixture of lidocaine with a~     long acting local anaesthetic is commonly used. This provides a rapid onset of blockade, but~     of a consistently shorter duration compared to a long acting local anaesthetic alone. We~     hypothesize that sequential perineural injection of lidocaine and bupivacaine provides~     similar onset but a longer duration of sensory block compared to the same dose and volume of~     local anaesthetic mixed in advance.~   "
138347|NCT01756430|"~     The aim of present study is to evaluate the efficacy and safety of Carvedilol SR versus~     Carvedilol IR in Patients With Essential Hypertension~   "
138348|NCT01756417|"~     The purpose of this study is to investigate whether there is a drug-drug interaction between~     multiple doses of canagliflozin (JNJ-28431754) and a single dose of metformin. The safety and~     tolerability of canagliflozin will also be assessed.~   "
138352|NCT01756365|"~     The study  Autologous cultured corneal epithelium (CECA) for the treatment of unilateral~     corneal lesions associated with limbal stem cell deficiency is the first clinical trial of~     this product manufactured at the LOEX laboratory. The culture of corneal epithelium strives~     to produce a reconstructed tissue with the therapeutical aim of treatment of unilateral~     limbal stem cell deficiency (only one eye is affected by the limbal stem cell deficiency).~     The study is a phase I/phase II study with the goal to evaluate safety and efficacy of the~     CECA graft for the treatment of human patients suffering from limbal stem cell deficiency.~   "
138353|NCT01756352|"~     Hypothesis: The central hypothesis underlying the proposed research study is that FET-PET~     will predict durable benefit in patients receiving anti-angiogenic benefit for presumed~     recurrent GBM (i.e. progression-free survival and overall survival). We have defined one~     primary specific aim, for which we expect to obtain definitive results, and two secondary~     aims, under which we plan to generate preliminary data to support a future, larger project.~   "
138354|NCT01756339|"~     This study will evaluate the safety and efficacy of an experimental antibiotic,~     solithromycin, in the treatment of adult patients with community-acquired pneumonia.~   "
138355|NCT01756326|"~     Fracture healing is a complex physiological process caused by interaction of cellular~     elements, cytokines and signaling proteins, which results in the formation of new bone~     (Gerstenfeld et al., 2003). Depending on fracture site, complexity, co-morbidities and other~     factors, 10% of all fractures will eventually fail to unite.~      Non-union fractures are defined as fractures that are at least six to nine months old and in~     which there have been no signs of healing for the last three months. Various causes have been~     evoked for impaired healing in hypotrophic (atrophic and oligotrophic) non-unions, including~     poor fracture stabilization, local infection and failure of the osteoblastic cells to~     multiply. Currently the treatment of choice for non-unions, particularly atrophic non-unions,~     is bone autograft (or allograft), combined or not with intramedullary nailing, plating, and~     external fixation devices (Kanakaris et al., 2007). This procedure produces good results but~     requires an invasive surgery of several hours under general anesthesia and a few days of~     hospitalization. Because of this, major complications have been reported in up to 20-30% of~     patients (Pieske et al., 2009, Zimmerman et al., 2009).~      This Phase 2b/3 study aims at demonstrating the safety and efficacy of PREOB®, a proprietary~     population of autologous osteoblastic cells, in the treatment of hypotrophic non-union~     fractures of long bones. PREOB® will be compared to Bone Autograft in a non-inferiority~     design.~   "
138356|NCT01756313|"~     The objectives of this study is to investigate if pre-treating the skin with an ablative~     fractional laser that creates small micropores in the skin:~        1. Increases the uptake of Methylaminolevulinat (MAL) in the skin.~        2. Decreases the required incubation time of MAL when performing photo dynamic therapy.~   "
138357|NCT01756300|"~     The RENABLATE feasibility study is a prospective, multi-center, non-randomized feasibility~     study to evaluate the safety and effectiveness of the investigational multi-electrode~     ablation catheter and integrated ablation system to treat resistant hypertension.~   "
138358|NCT01756287|"~     To assess whether Chinese ocular exercise is effective in altering distant and near visual~     acuity, ocular accommodation and visual symptoms in myopic teenager, and thus might have the~     possibility of slowing myopia progression in teenager through a weak but long-term effect.~   "
138359|NCT01756274|"~     The purpose of this study was to evaluate the performance of three Bayer Blood Glucose~     Monitoring Systems (BGMS) with neonatal blood. Blood samples used in this study were~     'left-over samples'. The blood samples were from heel sticks of neonates, collected (into a~     tube) and sent to the laboratory. All meter Blood Glucose (BG) results were compared with~     capillary plasma results obtained with a reference laboratory glucose method (Cobas® 6000~     instrument).~   "
138360|NCT01756261|"~     The objective of this survey is to evaluate effectiveness of EYLEA on Quality of Life (QOL).~     The QOL is evaluated by using Japanese version (v.1.4 - interviewer administered format) of~     National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) and compared at baseline~     and at the 6 and 12 months after start of EYLEA treatment.~   "
138361|NCT01756248|"~     This study is a regulatory post-marketing surveillance in Japan, and it is a local~     prospective and observational study of patients who have received EYLEA for Age-Related~     Macular Degeneration (AMD).~      The objective of this study is to assess safety and effectiveness of EYLEA using in real~     clinical practice.~      A total of 4,000 patients are to be enrolled and assessed in 3 years standard observational~     period. An annual follow-up survey will be conducted for 5 years at the longest after~     standard observational period.~   "
138362|NCT01756235|"~     The purpose of this study was to evaluate physical activity and its changes in participants~     with rheumatoid arthritis (RA) who were treated with adalimumab therapy in clinical practice.~   "
138363|NCT01756222|"~     The purpose of this registry is to gather information on patients with bicuspid aortic valve~     disease.~   "
138364|NCT01756209|"~     Aim: The purpose of this study was to evaluate both the effects of ibuprofen and/or~     acetaminophen for the acute treatment of primary migraine in children in or out prophylactic~     treatment with magnesium.~      Methods: The study had been approved by the Researchers Ethics Committee of the~     Pugliese-Ciaccio Hospital (protocol number 720/2010; EUDRACT NUMBER 2012-005737-36) and the~     children ranging from the ages of 5 to 18 years with at least four attack/month of primary~     migraine were enrolled. A Visual Analogical Scale was used to evaluate pain intensity at the~     moment of admission to the study (start of the study) and every month up to 18 months later~     (end of the study).~   "
138365|NCT01756196|"~     Many systemic reactions occur commonly after spinal steroid injections, especially in~     patients, and may be associated with underlying disease, such as hypertension and diabetes~     mellitus, as well as steroid dose and repetition of spinal steroid injection.~   "
138366|NCT01756183|"~     Exploratory the S-1 + Paclitaxel Chemotherapy for Creating the Operation Chance in the~     Patients with Unresectable Gastric Cancer~   "
138367|NCT01756170|"~     This phase III study is designed to examine if low-risk (lymph node negative), stage I a2-II~     b cervical cancer patients treated by paclitaxel/cisplatin chemoradiation have greater~     toxicities but similar survival rate as those treated by radiotherapy alone.~   "
138371|NCT01756118|"~     Primary objectives:~        -  To establish the maximum tolerated dose (MTD), and the recommended Phase 2 dose (RP2D)~          of BEZ235 when administered twice daily (BID) as a single agent in patients with~          relapsed or refractory acute leukemia~        -  To determine the dose-limiting toxicity (DLT)~      Secondary objectives:~        -  Assess the safety and tolerability of daily oral administration of BEZ235 with a BID~          schedule~        -  To describe preliminary anti-leukemic activity of BEZ235 in patients with acute leukemia~        -  To correlate changes in pharmacodynamic biomarkers with basic pharmacokinetic data~      Exploratory objectives:~        -  To assess pre-treatment phosphatidylinositol 3-kinase (PI3K) pathway-related genes in~          blast cells and all other malignant cells derived from blood or bone marrow.~        -  To assess the pharmacodynamic changes in components of the PI3K-protein kinase B~          (AKT)-mTOR pathway in bone marrow following treatment as potential predictive biomarkers~          of pharmacodynamic (PD) activity of BEZ235 in association with clinical responses.~        -  To identify potential resistance mechanisms and biomarkers that may correlate with~          efficacy and response from blood and bone marrow samples pre-and post-treatment in case~          of resistance~   "
138372|NCT01756105|"~     Gestational diabetes (GD) is defined by a hyperglycemia discovered during pregnancy, leading~     to fetal and maternal complications which may be prevented by reaching very strict glycaemia~     targets. Prevalence depends on patient's ethnic group and is about 6 to 14%. This prevalence~     is increasing due to increased GD risk factors (obesity, pregnancy over 35) and also because~     criteria of screening have been strengthened after the results of last studies. Usual~     treatment is diet and in case of failure insulin therapy with multiple injections which may~     lead to hypoglycemia and weight gain and is very difficult to manage for patients. Some~     studies have shown the comparable effect of metformin and insulin in about 50% of GD obese~     patients. The aim of our study is to evaluate efficacy of metformin, outcomes in mother and~     fetus and baby of metformin. In case of metformin failure, insulin will be added in order to~     obtain glycaemia in desired goals.Oxidative stress will be assessed in mother blood, baby~     umbilical cord blood, baby umbilical cord and placenta in 90 women and the oxidative stress~     compared between insulin and metformin alone treated patients.~   "
138373|NCT01756092|"~     The investigators will assess changes in breast appearance, graft retention and quality of~     life over one year in patients who have received direct autologous adipose tissue injection~     for the treatment of objectionable post-surgical breast deformities. These patients have~     undergone the resection of breast tissue to treat either benign or malignant breast disease.~   "
138374|NCT01756079|"~     This study is being done to find out if the addition of boceprevir to standard of care (SOC)~     treatment with peginterferon alfa-2b (PegIFN-2b) + ribavirin (RBV) is effective for~     participants with chronic hepatitis C (CHC) genotype 1 and cirrhosis who were not~     successfully treated by previous SOC. All participants will receive treatment with SOC alone~     for 4 weeks and then boceprevir will be added to the treatment regimen for 44 additional~     weeks of combined treatment.~   "
138375|NCT01756066|"~     To test the uptake of four different cost sharing discounts for enrolling in the Weight~     Watchers weight loss program as well as outcomes (program attendance and weight loss) over 12~     months.~   "
138376|NCT01756053|"~     This Phase IIa within-subject, cross-over pilot study will evaluate the effects of ABT-089~     (an experimental medication not approved by the FDA) when administered as 40mg oral once~     daily dose for 10 days, compared to placebo, on the following: abstinence-induced cognitive~     deficits, smoking withdrawal, smoking urges, smoking reward, and a brief, monitored quit~     attempt (~4 days). The key cognitive domains include: working memory, sustained attention,~     and response inhibition.~   "
138377|NCT01756040|"~     Necrotizing enterocolitis (NEC) is a life-threatening, gastrointestinal emergency~     characterized by increased intestinal permeability, affects approximately 7 to 10% of infants~     <1500 g birthweight, and typically occurs within 7 to 14 days of birth. Mortality is as high~     as 30-50%. Prematurity is the greatest risk factor for the development of NEC due to the~     physiological immaturity of the gastrointestinal tract and altered or abnormal gut~     microbiota. Several studies have demonstrated that the initiation of an intense systemic and~     local inflammatory cascade leads to intestinal necrosis. The human intestine is lined by a~     single layer of cells exquisitely responsive to multiple stimuli and is populated by a~     complex climax community of microbial partners. Under normal circumstances, these intestinal~     cells form a tight but selective barrier to friends and foes: microbes and most~     environmental substances are held at bay, but nutrients are absorbed efficiently. Epithelial~     barrier integrity is itself dynamic and matures over time starting soon after birth, though~     the mechanisms regulating dynamic permeability are poorly understood. Low birth weight,~     prematurity, and early postnatal age are associated with a leaky gut. Although intestinal~     permeability is higher at birth in preterm than term infants, there is usually rapid~     maturation of the intestinal barrier over the first few days of life in both populations. The~     investigators hypothesize that increased levels of measures of intestinal permeability (serum~     zonulin, urine lactulose/rhamnose (LA/Rh), and fecal alpha1- antitrypsin will identify~     infants at high risk for NEC. The purpose of the study is to determine whether measurement of~     intestinal permeability in serum will correlate with other markers of intestinal barrier~     leakiness measured in urine (LA/Rh) and stool (alpha-1 antitrypsin. If there is good~     correlation, then zonulin or serum rhamnose may be a useful measure to identify preterm~     babies at risk for NEC.~   "
138378|NCT01756027|"~     Up to 12 subjects will be enrolled. Enrolled subjects will receive one or two Ultherapy~     treatments on the cheeks, depending on their assigned study group. Follow-up visits will~     occur 14, 30 and 90 days post-treatment. Study images will be obtained pre-treatment, 30-60~     min post-treatment, and at each follow-up visit.~   "
138379|NCT01756014|"~     The investigators will evaluate the determinants of cerebral impairment in patients with~     non-ischemic heart failure compared to controls, and its relation to cognitive function. They~     hypothesize that patients with heart failure have impaired brain perfusion and hemodynamic~     factors are associated with cognitive dysfunction.~   "
138380|NCT01756001|"~     This randomized control trial will explore interventions to promote medication adherence~     using a novel electronic device that can track daily pill use. 500 subjects will be~     randomized into 4 arms of the experiment. In addition to a control arm, our three arms will~     be: reminders, financial incentives, and reminders and financial incentives.~   "
138424|NCT01755416|"~     Hypothesis: In type 1 diabetes mellitus, in the setting of a closed loop glucose control~     system: adjunctive therapy with Liraglutide will afford better post-prandial glycemic~     excursions than insulin mono-therapy.~      Specific Aim: To determine if post-prandial glucose excursions are lowered with the addition~     of Liraglutide compared to insulin mono-therapy.~      Study Design: This is a randomized open labeled crossover design trial comparing adjuvant~     Liraglutide and insulin Vs. insulin mono-therapy using the ePID closed-loop system for~     insulin delivery.~   "
138381|NCT01755988|"~     The number of people with heart failure is increasing in the western world. Mainly due to~     better treatment of myocardial infarctions and ageing of the population. The amount of health~     care workers is unfortunately not increasing. We want to investigate how two electronic~     devices (a website and an interactive web-based platform) influence the self-care, quality of~     life, hospitalizations and mortality by delivering care from a distance. We also want to~     investigate if a higher quality of care is delivered despite of less frequent visits to a~     nurse and/or doctor. The study takes place in the Netherlands and is a randomized trial.~     Patients with heart failure, registered by an outpatient heart failure clinic or general~     practitioner can take part. They will be randomized to 3 groups: group 1 receives standard~     care, group 2 receives standard care with the website, group 3 receives an adjusted care~     pathway, with both the website and the interactive web-based platform connected to a~     telemonitoring system. In this group all routine consultations with heart failure nurses and~     general practitioner will be substituted by this device.~   "
138382|NCT01755975|"~     The treatments used to treat lymphoma and multiple myeloma sometimes do not always work well~     or they may only work for a short period of time. This is why new treatments are being~     tested.~      This study will test a new combination of two drugs that are already approved by the Food and~     Drug Administration for treatment of certain kinds of blood cancers. These drugs are~     romidepsin and lenalidomide. Both these drugs by themselves have been used to treat lymphoma~     or multiple myeloma. However, while these drugs are routinely used alone, this is the first~     time they will be tested together. The mechanism of action of both drugs is not well~     understood but both have been shown to to be effective by themselves in lymphoma and multiple~     myeloma.~   "
138383|NCT01755962|"~     This project is prompted by the urgent public health need to identify novel strategies to~     prevent cardiovascular disease (CVD) and type 2 diabetes (T2D). The higher prevalence of CVD,~     T2D, and metabolic syndrome in obese individuals is a major healthcare concern. Therefore,~     finding optimal intervention strategies to combat these growing epidemics is imperative.~   "
138384|NCT01755949|"~     Colchicine will lower C-reactive protein (CRP) in chronic atrial fibrillation and reduce the~     rise in CRP which occurs following atrial fibrillation ablation~   "
138385|NCT01755936|"~     Aortic stenosis is the most common adult valvular heart disease in the western world. Heart~     failure and sudden cardiac death are complications associated with aortic stenosis. In~     symptomatic individuals, valve replacement is often the only effective treatment. However,~     there are no good markers to identify patients who may benefit from early surgery before~     symptoms developed. The purpose of the study is to test the hypothesis that the presence~     heart muscle scarring on the cardiac magnetic resonance imaging may predict a worse outcome~     in patients with aortic stenosis, and thus may be helpful in identifying patients for early~     valve replacement.~   "
138386|NCT01755923|"~     Gefitinib, the first EGFR-tyrosine kinase inhibitor (TKI) in the world was examined as~     monotherapy in two phase Ⅱ studies called IDEAL trials. Response rate with doses of 250mg and~     500mg/day were similar, ranging from 10% to 18%. Posterior analysis demonstrated that~     patients with EGFR mutation had an improved response rate (RR) to gefitinib compared to~     wild-type patients (46% versus 10%). The early trials that evaluated EGFR-TKIs for the~     second- and third-line settings of advanced NSCLC did not select patients on the basis of any~     EGFR marker. The IEESSA Survival Evaluation in Lung Cancer (ISEL) trial evaluated the role of~     second-line gefitinib 250mg/day in 1692 patients with advanced NSCLC. Patients with EGFR~     mutations had higher RR than patients without (37.5% versus 2.6%). From the above results,~     the response rate in patients without EGFR gene mutation was obviously different (10% versus~     2.6%). The methods used for detecting EGFR gene mutation was different, which might~     contribute to the difference of response rates. In IDEAL trial, EGFR gene mutation was~     detected by sequencing. But in ISEL trial, EGFR gene mutation was detected by ARMS. As we~     know, ARMS was more sensitive than sequencing in detecting EGFR gene mutation. That is to~     say, in IDEAL trials some EGFR mutant patients were misdiagnosed as wild-type patients, so~     the response rate was higher. Recently, Wu Yi-Long et al reported that relative abundance of~     EGFR mutations predicted benefit form gefitinib treatment for advanced non small cell lung~     cancer. The study cohort was all Chinese. In this study, the objective response rate in~     patients without EGFR mutation detected by ARMS was 16.1%, which was significantly higher~     than the response rate of docetaxel. But in 2012 American society of clinical oncology (ASCO)~     annual meeting, the Tailor study in which Italian NSCLC patients were enrolled demonstrated a~     clear superiority of docetaxel over erlotinib as second line treatment for patients without~     EGFR mutations in exons 19 or 21. So we wonder if the racial difference is the determinant~     factor. So the purpose of this trial is to compare the efficacy and safety of gefitinib with~     docetaxel as second-line therapy for advanced or metastatic Chinese NSCLC patients with~     wild-type EGFR.~   "
138387|NCT01755910|"~     The Left thoracic paravertebral block have a different effect on heart's autonomic nervous~     system, as measured with Heart Rate Variability, compared to Right interscalene block~   "
138388|NCT01755897|"~     We will conduct a trial to determine whether paclitaxel/cisplatin (TP) as an adjuvant~     chemotherapy after radical surgery improve disease-free survival (DFS) and overall survival~     (OS), as well as the quality of life (QoL) among early-stage (FIGO stage IB-IIA) cervical~     cancer patients with risk factors.~   "
138389|NCT01755884|"~     The aim of the study is to induce tolerance to wheat in wheat allergic children via oral~     desensitization therapy. The hypothesis is that oral administration of wheat with increasing~     dosing will increase the individual threshold for allergic reactivity to wheat protein (i.e.~     desensitization) and even result in no reactivity (i.e. full tolerance). Along with this, the~     risk for severe allergic reaction to wheat protein is minimized and the diet of patients can~     partly or completely be normalized. In addition to clinical measures, the immunological~     mechanisms of desensitization therapy are studied in detail at cellular and molecular level.~   "
138390|NCT01755871|"~     The purpose of this study is to explore immunomodulatory and immunosuppressive mechanisms of~     action of fingolimod in patients with Relapsing remitting multiple Sclerosis to collect data~     on biomarkers after initiation of fingolimod treatment.~   "
138391|NCT01755858|"~     The primary objective of this trial is to assess the effects of Bendavia on renal blood flow~     and renal function in atherosclerotic renal artery stenosis (ARAS), compared with placebo in~     patients with ARAS who receive one dose of study drug infused 30 minutes before and 3 hours~     after percutaneous transluminal angioplasty of the renal artery (PTRA).~   "
138392|NCT01755845|"~     The purpose of this study is to determine the efficacy and safety of consolidation~     chemotherapy with paclitaxel plus cisplatin (2 cycles per 3 weeks) following radical~     hysterectomy and adjuvant chemoradiation (2 cycles per 4 weeks) for high risk early stage~     cervical cancer.~   "
138393|NCT01755832|"~     The purpose of this study is to investigate the effects of heated pool group exercises for~     patients with inflammatory rheumatic diseases with regard to symptoms (pain, fatigue,~     stiffness and ability to carry out daily activities).~   "
138425|NCT01755403|"~     o study population pharmacokinetics in Benznidazole-treated adult patients with Chronic~     Chagas Disease to get information to optimize drug doses.~   "
138394|NCT01755819|"~     Background:~      Failure of graft incorporation and tunnel widening (TW) after anterior cruciate ligament~     (ACL) reconstruction has been frequently reported in the literature. The etiology of TW is~     still not fully understood.~      Patients and Methods:~      This is a prospective randomized study including 60 patients, conducted in a Level I trauma~     center in Innsbruck, Austria. The study protocol was approved by the hospital ethics~     committee. This study is planned and conducted following the Consolidated Standards on~     Reporting Trials (CONSORT) guidelines. Aperture fixation is performed using BioComposite~     interference screws (Arthrex, Naples, FL). Extracortical fixation is performed using the ACL~     Tightrope (Arthrex, Naples, FL). TW is measured on CT scan postoperative, after 6 and 24~     months. Clinical outcome is determined at 1, 2 after reconstruction, IKDC with KOOS~     Knee-related QoL subscale, Lysholm, Tegner Activity scores, hop tests and KT-1000~     measurements are performed.~      Hypothesis:~      The purpose of this randomized controlled trail is to determine the influence of two~     different fixation methods on TW and clinical outcome after anatomic ACL reconstruction using~     hamstring graft in young and active patients.~   "
138395|NCT01755806|"~     This study seeks to compare aortic dimension changes during cardiac cycle in patients with~     and without aortic valve calcification and to evaluate its correlation with aortic valve~     calcium score in former group.~   "
138396|NCT01755780|"~     The Left interscalene block has a different effect on heart's autonomic nervous system,~     compared to Right interscalene block. This effect is evident on the occurrence of bradycardia~     and hypotension during shoulder surgery in the beach chair position~   "
138397|NCT01755767|"~     The purpose of this study is to determine if tivantinib (ARQ 197) is effective in treating~     patients with MET diagnostic-high hepatocellular carcinoma (liver cancer) who have already~     been treated once with another therapy.~   "
138398|NCT01755754|"~     A multi-center, open-label, randomized, two-period, crossover non-inferiority trial to assess~     the functionality of female condoms with a silicone elastomer vaginal ring.~   "
138399|NCT01755741|"~     This trial will assess the potential impact of a vaginal ring on condom use by comparing the~     performance (total clinical failure, clinical slippage, and clinical breakage) of a standard~     male lubricated latex condom when the female partner is wearing the vaginal ring and when the~     female partner is not wearing the vaginal ring.~   "
138400|NCT01755728|"~     There is a report that acetaminophen may have a role in pharmacological closure of PDA~     (Patent arterial duct) in preterm infants.~      The investigators conducted this open label non randomized and non control study to try to~     support that report.~   "
138401|NCT01755715|"~     The main objective of this study is to compare, in a randomised, controlled and prospective~     fashion, initiation of intrauterine contraception (IUC) at about immediate (0 to 3 days)~     versus 2 to 4 weeks post medical abortion with regard to expulsions and use of contraception~     one year after abortion.~   "
138402|NCT01755702|"~     This study will compare a fast-absorbing paracetamol plus caffeine formula with placebo and~     an over-the-counter dose of paracetamol and ibuprofen to treat episodic tension headache.~   "
138403|NCT01755689|"~     The purpose of this study is to evaluate safety and immunogenicity of GSK Biologicals'~     meningococcal vaccine GSK134612 (MenACWY-TT) co-administered with Cervarix as compared to~     MenACWY-TT and Cervarix administered alone and the co-administration of MenACWY-TT with~     Cervarix and Boostrix as compared to MenACWY-TT administered alone and Cervarix~     co-administered with Boostrix.~   "
138404|NCT01755676|"~     The purpose of this study is to evaluate efficacy of orlistat 60 mg as adjuvant treatment of~     Obesity in adults.~   "
138405|NCT01755663|"~     Ivabradine may be better than Metoprolol for controlling heart rate before Coronary CTA.~   "
138406|NCT01755650|"~     The purpose of this study is to investigate the safety and potential effectiveness of the~     imaging compound 18F FPM for finding sites of malignancies.~   "
138407|NCT01755637|"~     The purpose of the study is to compare the pharmacokinetic profiles of two Albendazole tablet~     formulations manufactured under the different granulation processes in healthy Chinese adult~     males.~   "
138408|NCT01755624|"~     The study is a prospective, randomly controlled phase II trial, designed to test the~     efficacy, safety and neurocognitive outcomes of a medical device, the NovoTTF-100A, in the~     treatment of NSCLC patients with controlled systemic disease, following optimal standard~     local treatment for 1-5 brain metastases (BM). The device is an experimental, portable,~     battery operated device for chronic administration of alternating electric fields (termed~     TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated~     electrode arrays.~   "
138409|NCT01755611|"~     The aim of the study is to compare the bioavailability of two medications containing 100 mg~     of minocycline in capsules to determine bioequivalence. They are Minocycline (Minocin® is a~     registered trademark of Wyeth Holdings Corporation), and Minocycline (Minopac® is a~     registered trademark of LABORATORIOS DERMATOLOGICOS DARIER, S.A. DE C.V.). Study design is~     randomized, open, cross-over with two single administrations with two periods and two~     sequences with a wash-out period of 7 days between the periods. Subjects in the study will be~     25 healthy male volunteers, 18-55 years, Blood samples will be obtained at 0.0, 0.33, 0.66,~     1.0, 1.33, 1.66, 2.0, 2.33, 2.66, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 48.0, and 72.0 hours~     after medication administration in each period. Plasma minocycline levels will be determined~     by HPLC method with UV detection with previously validated method. Minocycline concentration~     data will be used to calculate Cmax, AUC0-t, and AUC0-inf with WinNonlin 5.3 software. The~     log transformed pharmacokinetics parameters of test and reference medications will be~     compared calculating ratios and 90% confidence intervals. Any adverse event will be reported.~   "
138410|NCT01755598|"~     The purpose of this study is to evaluate the protective efficacy of two doses of GSK~     Biologicals' candidate TB vaccine against pulmonary TB, as compared to placebo. The efficacy~     will be evaluated in adults living in TB endemic countries and aged 18 - 50 years because~     pulmonary TB occurs frequently in these countries and age range. In addition, the safety and~     immunogenicity of the candidate tuberculosis vaccine will be evaluated in a subset of~     volunteers.~   "
138436|NCT01755260|"~     The aim of this study is to compare the closure rate of pancreatic fistula (PF) after~     pancreaticoduodenectomy (PD) under various types of nutrition.~   "
138411|NCT01755585|"~     Radiation therapy (RT) is used as an effective local treatment modality to inhibit cell~     proliferation, induce cell death and suppress tumor growth. To improve the treatment outcome,~     in terms of both locoregional control and survival, the concurrent use of chemotherapy during~     radiation therapy (CCRT) is now the standard treatment for various malignancies, especially~     locally advanced cancers. Among the drugs used to enhance RT effect, 5-fluorouracil (5-FU) is~     one of the most commonly used chemotherapeutic agents of CCRT.~      In the past, RT was solely used as a local treatment and its effect was estimated by local~     effect model. However, growing evidence shows that irradiation has direct DNA~     damage-dependent effects as well as sending signals to neighboring cells. Recently, we~     reported that abdominal irradiation could significantly modulate the systemic~     pharmacokinetics of 5-FU at 0.5 Gy, off-target area in clinical practice, and at 2 Gy, the~     daily treatment dose for target treatment in an experimental rat model. Additionally, the~     results from a clinical investigation showed that colorectal cancer patients with lower AUC~     of 5-FU during adjuvant chemotherapy had lower disease-free survival. Taken together, these~     lines of evidence support the importance and necessity to search for the mediators~     responsible for the unexpected effect of local RT on systemic pharmacokinetics of~     chemotherapeutic agents, such as 5-FU.~      In the present study, the investigators investigated whether the phenomena and mechanism of~     RT-PK is a fact for different anticancer drugs in human.~   "
138412|NCT01755572|"~     Purpose:~      The purpose of this study is to further study the mechanism by which liraglutide, a~     relatively new anti-hyperglycemic medication, might lower blood pressure in patients with~     Type 2 diabetes and high blood pressure.~   "
138413|NCT01755559|"~     Study treatments:~        -  Artemether-lumefantrine~        -  Artesunate-amodiaquine~        -  Dihydroartemisinin-piperaquine~      Location:~      Maradi, Niger~      Principal Objective:~      To measure the clinical and parasitological efficacy of the three artemisinin combination~     therapies over a period of 42 days from the start of treatment and with polymerase chain~     reaction assay (PCR) adjustment.~      Secondary objectives:~        -  To determine the blood concentration of the non-artemisinin component of the treatment~          (lumefantrine, desethylamodiaquine or piperaquine) at day 7~        -  To assess the incidence of adverse events during the follow-up period;~        -  To measure speed of parasite clearance~      Methods:~      In vivo non comparative study as for WHO standardised protocol. The study also measure the~     concentration of the non-artemisinin component.~      Target population:~      Children under 5 years of age consulting the integrated health centres of Andoumé and~     Dix-sept portes in Maradi.~      Sample size:~      221 patients per study treatment; 663 patients in total.~      Treatment allocation:~      Random.~      Outcomes:~        -  Early treatment failure,~        -  Late clinical failure,~        -  Late parasitological failure,~        -  Adequate clinical and parasitological response.~      Analysis:~        -  Cumulative success or failure rate (Kaplan-Meier analysis).~        -  Proportions of early treatment failures, late clinical failures, late parasitological~          failures, and adequate clinical and parasitological response (called also Per-protocol~          analysis).~   "
138414|NCT01755546|"~     The purpose of the long-terms study is to evaluate the safety, tolerability, and analgesic~     efficacy of EN3409 in subjects with moderate to severe chronic pain requiring continuous~     around-the-clock opioid analgesia for an extended period of time.~   "
138415|NCT01755533|"~     The goals of this study are to develop a middle school substance use prevention curriculum~     for underserved rural youth and evaluate its efficacy compared to the existing, multicultural~     curriculum. In addition, we are studying how the curricula get taught by the teachers.~      Hypothesis 1: When compared to students in the control condition, students in the treatment~     conditions will report less substance use, more conservative norms, less positive~     expectations about substance use outcomes, and better life and communication skills.~      Hypothesis 2: When compared to students in the control condition, students in the researcher~     adaptation condition will report less substance use, more conservative norms, less positive~     expectations, and better life and communication skills.~      Hypothesis 3: When compared to students in the control condition, students in the teacher~     adaptation condition will report less substance use, more conservative norms, less positive~     expectations, and better life and communication skills.~      Hypothesis 4: Researcher adaptation will have a greater impact on substance use, norms, and~     expectations than teacher adaptation.~   "
138416|NCT01755520|"~     The primary objective of this study ist to test the hypothesis that ticagrelor is superior to~     Aspirin (ASA) fort he prevention of major cardio- and cerebrovascular events (MACCE) in~     patients undergoing artery bypass operation.~      The primary efficiacy MACCE-endpoint is the composite of cardiovascular death, myocardial~     infarction, recurent revascularisation, and stroke at twelve month after coronary artery~     bypass operation.~   "
138417|NCT01755507|"~     Evaluation of the efficacy of different doses of nor UDCA vs. placebo for the treatment of~     Primary Sclerosing Cholangitis (PSC). Identification of optimal dose(s)for the treatment of~     PSC.~   "
138418|NCT01755494|"~     The primary objective of this study is to assess the pharmacokinetic parameters of~     saxagliptin and metformin in healthy male Chinese subjects.~   "
138419|NCT01755481|"~     To evaluate the effects of feeding an infant formula containing L. paracasei ssp. paracasei~     strain F19 or Whey Protein Concentrate.~   "
138420|NCT01755468|"~     Type 2 diabetes mellitus is a chronic metabolic disorder characterized by progressive~     deterioration in the function of the pancreatic beta-cells, which are the cells that produce~     and secrete insulin (the hormone primarily responsible for the handling of glucose in the~     body). The investigators propose a pilot randomized controlled trial to determine whether~     intermittent intensive insulin therapy is an effective therapeutic strategy that can preserve~     pancreatic beta-cell function and maintain glycemic control early in the course of type 2~     diabetes.~   "
138421|NCT01755455|"~     This study questions whether low-dose ferrous sulfate taken by mouth daily for 6 weeks~     increases hemoglobin concentration in adult subjects with cystic fibrosis and hypoferremic~     anemia.~   "
138422|NCT01755442|"~     This is a phase 1, randomized, double-blind, placebo-controlled, 2-way crossover study to~     evaluate the effect of AMG 151 on 24-hour ambulatory blood pressure and glucose levels in~     subjects with type 2 diabetes mellitus who are on a stable regimen of metformin alone,~     metformin and a dipeptidyl peptidase-4 inhibitor (DPP4), metformin and a thiazolidinedione~     (TZD), or metformin, a DPP4, and a TZD for a minimum of 3 months prior to randomization.~   "
138426|NCT01755390|"~     Primary Objective:~      - To determine the maximum tolerated dose (MTD) and the dose-limiting toxicity (DLT) of~     XRP6258 when given as a weekly 1-hour intravenous (i.v.) infusion for the first 4 consecutive~     weeks of each 5-week treatment cycle (Day 1, Day 8, Day 15, Day 22 of each 5-week treatment~     cycle).~      Secondary Objectives :~        -  To define the safety profile of the drug~        -  To establish the recommended dose and time interval for future Phase II trials~        -  To determine the pharmacokinetic (PK) profile of XRP6258 in man~        -  To assess the absolute oral bioavailability of XRP6258 at the i.v. recommended dose~          (following Protocol Amendment No. 2)~        -  To look for evidence of antitumor activity~   "
138427|NCT01755377|"~     Chagas disease is endemic to Latin America, and is of emerging importance in non-endemic~     countries because migration of people infected with T. cruzi. Current methods for diagnosis~     of T. cruzi infection are not ideal. Existing drugs for treatment are very limited, produce~     severe side-effects, and their effectiveness cannot be properly evaluated. Reliable~     biomarkers for prognosis, early diagnosis and effectiveness of treatment will be~     investigated.~   "
138428|NCT01755364|"~     This is an open study of the use of AdimFlu-V (2012-2013 season) vaccine in young healthy~     subjects. Subjects aged equal to or over 9 years old and less than 18 years old will receive~     one dose of vaccine (0.5 mL) by intramuscular injection into the upper arm. Subjects aged~     equal to or over 3 years old and less than 9 years old will received two doses of vaccine~     (0.5 mL) by intramuscular injection into the upper arm separated by 4 weeks (28 days). Safety~     outcomes included immediate reactions at the time of vaccination, solicited local and~     systemic reactions within 7 days after each vaccination, unsolicited adverse events observed~     since first vaccination to 28 days after the last dose of vaccination, and serious adverse~     events during the observation. Sera prepared from blood samples will be collected from each~     subject immediately prior to, and 4 weeks after each vaccination. Anti-hemagglutinin (HA)~     antibody titers will be determined using the WHO hemagglutination inhibition reference~     technique. The central laboratory who is responsible for antibody titrations will not be~     aware of the background of blood samples (e.g., pre- or post-serum), it is also called~     observer-blinded. All subjects will be followed, either by clinical visit or by telephone~     contact, for 8 weeks after the last vaccination for safety reasons.~   "
138429|NCT01755351|"~     An effective treatment adherence was a key to make the treatment success, some reports had~     shown that psychologicl factors impact patients adherence seriously,however, in China, the~     researches were only limited to depression and diabetes,diabetes distress was neglected. Some~     western studies had demonstrated the impact of diabetes distress on diabetes. Thus, we~     hypothesized that: 1.perhaps our present depression-oriented health education was inadequate~     to promote patients' adherence, diabetes distress might played a more important part than~     depression in patients' treatment adherence. 2. there might be a high prevalence of diabetes~     distress in Chinese type 2 diabetes; so, the comparative study between diabetes distress and~     depresion was conducted.~      Objectives: to explore the relationship of diabetes-related distress and depression，and to~     compare the influence of diabetes distress and depression on treatment adherence in Chinese~     type 2 diabetes .~      Research design and method:we surveyed 200 type 2 diabetic patients from 2 third-class~     hospitals using the Diabetes Distress Scale, Zung Self-rating Depression Scale, and Revised~     Treatment Adherence in Diabetes Questionnaire (RADQ)simultaneously.~   "
138430|NCT01755338|"~     The purpose of this study is to investigate if methylprednisolone is effective in reducing~     the cerebral inflammatory response after open heart surgery with cardiopulmonary bypass.~   "
138431|NCT01755325|"~     It is an open-label, randomized, double blind, placebo-controlled parallel-group,~     multi-center study to evaluate the efficacy and safety of Compound realgar formula~     Realgar-Indigo naturalis Tablet combined with Imatinib will be compared with imatinib alone~     in adult patients with diagnosed Philadelphia chromosome-positive (Ph+) chronic myelogenous~     leukemia in the chronic phase (CML-CP).~   "
138432|NCT01755312|"~     This study to evaluates how a med reminder affects the patient's ability to take medications~     as prescribed~   "
138433|NCT01755299|"~     The line of 5-hour Energy® products are available over-the-counter as energy supplements.~     The appeal of these products involves ease of use, low caloric value, and the absence of~     sugar to prevent a crash later in the day. The definitive efficacy and potency of the~     products is unknown due to the lack of evidence-based clinical reports. It is suspected that~     the efficacy related to these products is due to the caffeine content, which was reported as~     138 mg per 2-ounce bottle in an online caffeine content chart. The purpose of this~     randomized, double-blind, placebo controlled, four way crossover study is to evaluate the~     efficacy of 5-hour Energy®, 5-Hour Energy Decaf®, caffeine, and placebo for perceived~     energy and wakefulness.~   "
138434|NCT01755286|"~     The purpose of this study is to describe the safety and tolerability of two dose levels of~     OTO-201, placebo and sham when administered intra-operatively in pediatric subjects with~     bilateral middle ear effusion who require tympanostomy tube placement.~   "
138435|NCT01755273|"~     Pancreaticoduodenectomy (PD) includes en bloc resection of duodenum, head of pancreas,~     proximal jejunum, distal common bile duct (CBD), gallbladder, and distal stomach, which was~     followed by complicated reconstructions. Therefore, PD causes change of physiological~     functions, containing insufficiency of exocrine and endocrine pancreatic function,~     malabsorption of nutrients, impairment of gut peristalsis, and hepatic steatosis . On the~     other hand, DM may also resolve after PD in cases with pancreatic ductal adenocarcinoma. From~     the study of bariatric operation, resolution of DM may occur even before body weight loss.~     Postulated mechanism of resolution of DM after bariatric operation included foregut and hind~     gut theory. Actually, both hindgut and foregut effects on sugar control are achieved to some~     extent after pancreaticoduodenectomy. First, most of the duodenum is routinely removed in PD~     and there will be no food passage through duodenum (foregut theory) after PD. Second,~     proximal 10 cm of jejunum will be removed in PD and another 30~ 40 cm- long jejunum will be~     brought up for pancreatic and biliary anastomosis, which will make the last enteral~     anastomosis (gastrojejunostomy or duodenojejunostomy) be created at site about 50-60 cm~     distal to Treitz ligament. Therefore, food will directly pass into distal jejunum (hindgut~     theory). In our preliminary study, 35% patients have resolution of diabetes after PD,~     especially for ones with new-onset DM. Further, a prospective randomized clinical trial will~     be conducted to address if modified distal gastro-/duodeno-jejunostomy results in a higher~     proportion of diabetes remission compared with standard PD.~   "
138437|NCT01755247|"~     This is a 3 day study to assess safety and tolerability of a new topical gel product, NVN1000~     with and without the application of a commercially available moisturizer in approximately 15~     healthy subjects. The test product will be applied to the forehead of healthy volunteers once~     daily for 3 days. One group of subjects will have a moisturizer applied to the same area 15~     minutes after the test gel was applied and one group of subjects will be treated with the gel~     vehicle which does not contain the active product. The hypothesis is that the application of~     moisturizer will not effect safety or local tolerability.~   "
138438|NCT01755234|"~     80% of 25 million American who undergo surgery describe moderate to severe pain. The use of~     multimodal analgesic techniques can attenuate patient's postoperative pain and several~     different medication have been found to be effective. Pain can significantly affect patient's~     quality of recovery after surgery. Volatile anesthetics can increase sensitivity to pain at~     the low concentrations present on emergence from anesthesia. Propofol may have analgesic~     effect at sedative doses. The effects of propofol,when used for anesthesia maintenance, on~     postoperative pain have demonstrated controversial results with some investigators showing a~     potential benefit whereas others have not shown any benefit. Propofol for maintenance of~     anesthesia has been advocated as an strategy for high risk patients even though it has shown~     controversial results on reduction of Post operative nausea and vomiting. A comparison of~     propofol vs.volatile anesthetic in regards to the time required by patients to meet discharge~     criteria has also shown conflicting results.The QOR 40 is a validated instrument that has~     been specifically developed to evaluate patients recovery after anesthesia and surgery.~      The purpose of this study is to compare the effects of maintenance of anesthesia with two~     agents (Propofol and Sevoflurane) on quality of recovery after ambulatory surgery~      Significance: the results of this study can lead to the discovery of an anesthesia technique~     that is associated with a better recovery for patients after ambulatory surgery.~      Research question is: do patients anesthetized with propofol have a better quality of~     recovery after ambulatory anesthesia than patients anesthetized with Sevoflurane? The~     hypothesis: patients anesthetized with propofol will have better quality of recovery than~     patients anesthetized with Sevoflurane after ambulatory surgery.~   "
138439|NCT01755221|"~     The purpose of this research study is to better understand whether information obtained from~     a pH probe can help physicians predict whether a patient will respond to the medication that~     is prescribed for laryngopharyngeal reflux (LPR). The current treatment given to individuals~     who are diagnosed with LPR is a course of proton pump inhibitor (PPI) medication. Subjects~     who agree to participate in this study will have a small flexible tube (about the width of a~     piece of cooked spaghetti) placed in their throat. This tube measures the pH in the throat~     over a period of 24 hours and helps physicians study the relationship between pH level, LPR~     symptoms, and the effectiveness of PPI therapy. This study may help physicians find out if~     certain symptoms or characteristics can help them predict if the PPI medication will be~     effective for each patient. After probe removal, subjects will receive compensation. They~     will return to the clinic at their regularly scheduled follow-up visit with the physician, 8~     to 12 weeks after starting the PPI medication. At that time, subjects can choose to~     participate in an optional probe placement.~   "
138440|NCT01755208|"~     This pilot clinical trial studies light-scattering spectroscopy in finding disease in~     patients with stage II-III breast cancer. Diagnostic procedures, such as light-scattering~     spectroscopy, may help find and diagnose breast cancer~   "
138441|NCT01755195|"~     Background:~      - Cabozantinib is a cancer treatment drug that blocks the growth of new blood vessels in~     tumors. It can also block a chemical on tumor cells that allows the cells to grow. A similar~     drug, pazopanib, is used to treat types of cancer known as sarcomas. Researchers want to see~     if cabozantinib can be an effective treatment for types of soft tissue sarcoma that have not~     responded to earlier treatments.~      Objectives:~      - To test the effectiveness of cabozantinib for soft tissue sarcomas that have not responded~     to standard treatments.~      Eligibility:~      - Individuals at least 18 years of age who have soft tissue sarcomas that have not responded~     to standard treatments.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood samples~          will be collected. Imaging studies and other tests will be used to study the tumor~          before the start of treatment.~        -  Participants will take cabozantinib tablets daily for 28-day cycles of treatment. The~          tablets should be taken whole on an empty stomach.~        -  Treatment will be monitored with frequent blood tests and imaging studies.~        -  Participants will continue to take cabozantinib for as long as the tumor does not become~          worse and the side effects are not too severe.~   "
138442|NCT01755182|"~     The purpose of this study is to verify if adding a locoregional treatment of liver metastasis~     (with trans-arterial embolization-TAE) to medical treatments of proven efficacy can prolong~     the progression free survival of patients affected by neuroendocrine tumors (NET) with~     inoperable liver metastases~   "
138443|NCT01755169|"~     This study is designed to select the most tolerable dose of oral ketamine for children with~     chronic pain. Children will be given either placebo or one of three dosages of oral ketamine~     for 2 weeks. The dosage that is most tolerable will be selected for further study.~   "
138444|NCT01755156|"~     The purpose of this study is to assess the safety and efficacy of omarigliptin compared to~     placebo in participants with inadequate glycemic control on metformin monotherapy. The~     primary hypothesis is that after 24 weeks, the addition of treatment with omarigliptin~     provides greater reduction in hemoglobin A1c (A1C) than placebo.~   "
138445|NCT01755143|"~     The purpose of this study is to test the safety and effectiveness of the Medtronic CapSureFix~     Novus Model 5076 lead when patients are implanted with the Medtronic Advisa MRI pacemaker and~     undergo an MRI scan.~   "
138446|NCT01755130|"~     The goal of this clinical research study is to learn if an imaging device called the Laser~     Optoacoustic and Ultrasonic Imaging System Assembly (LOUISA-3D) is effective in detecting and~     monitoring changes in breast tumors.~   "
138447|NCT01755117|"~     Total Knee Replacement can be performed under the combination of posterior lumbar plexus~     block plus sciatic nerve block. The investigators can have the same outcome by performing~     instead of posterior lumbar plexus block more peripheral nerve blocks. More specifically~     under the combination of sciatic nerve block plus femoral nerve block plus obturator nerve~     block.~   "
138448|NCT01755104|"~     The purpose of the study is to evaluate the impact of the intake of a dietary supplement~     STABLOR™ on the change of the abdominal visceral fat mass in patients with a metabolic~     syndrome.~   "
138449|NCT01755091|"~     This is a proof of concept study to determine the safety and efficacy of dronabinol for the~     treatment of obstructive sleep apnea syndrome (OSA).~   "
138450|NCT01755078|"~     The study is designed to compare sevelamer vs. calcium-based phosphate binder in hemodialysis~     patients to achieve full-scale of medical care, including reduction of atherosclerotic risk~     factors, reduction of vascular access reconstruction rate, and pharmacoeconomic analysis.~   "
138452|NCT01755052|"~     SILVER-AMI is a research study of older persons who are admitted to the hospital with a heart~     attack. Patients will be interviewed in the hospital and again 6 months later. The~     researchers will also collect detailed medical record information to understand the effect of~     heart attacks on older persons.~      The research team at Yale University will use this information to develop a risk model that~     can be used to help doctors predict recovery. The goal of the study is to help older people~     in the future make well-informed decisions about their health care during a heart attack.~   "
138453|NCT01755039|"~     The purpose of the study is to determine the frequency and management of respiratory~     incidence in patients with invasive out-of-hospital ventilation, either living at home for~     elderly people allay to a weaning centre or at home. Further, the mortality and the frequency~     of hospital admission will be analyzed.~   "
138454|NCT01755026|"~     Patients undergoing Cesarean delivery (C-Section) with a body mass index of 35 or greater~     (this BMI number is in the obese range) will be given either 2 grams or 4 grams of an~     antibiotic before surgery. The antibiotic is intended to prevent infection from the~     surgery.It is unknown what the best dose for large women is for the usual medicine used for~     this purpose (an antibiotic medicine called cefazolin).Samples of the tissue just under the~     skin will be biopsied at the time the incision is made and at the time the cut is stitched or~     stapled closed. A sample of the muscle of the womb will be taken as the womb is stitched~     closed after the delivery. Blood tests will be done at the start and end of surgery to test~     the antibiotic level. A blood sample will be taken from the umbilical cord after the baby has~     been delivered and the umbilical cord has been cut. The umbilical cord blood sample will be~     tested for the antibiotic level.These tests will be used to find out if the usual dose of~     medicine is enough or if more medicine is needed to prevent infection in large women~     undergoing c-sections.~   "
138455|NCT01755013|"~     Successful palliation of biliary obstruction is the main goal for reducing morbidity and~     mortality in patients with biliary disease and biliary obstruction related to~     cholangiocarcinoma. Surgical intervention for the sale is unfortunately complicated by a~     30-day postoperative mortality rate of between 7 and 24%. Moreover, because of recovery time~     the quality of life following surgery is only improved in a minority. At present endoscopic~     insertion of a plastic or metal stent is the method of choice to relieve obstructive jaundice~     without the high morbidity and mortality associated with surgery. But this relief is~     unfortunately temporary since stents tend to become obstructed and the fact that effective~     biliary drainage in the proximal lesion is challenging.~      Photodynamic Therapy (PDT) is a new therapeutic approach that specifically targets neoplastic~     cells. This therapy involves the intravenous administration of a photosensitizing agent~     followed by activation of the agent by illumination with non-thermal light of a specific~     wavelength, resulting in cell death from direct cytotoxicity and ischemic necrosis. A~     randomized controlled trial study by Ortner et all confirmed the significant advantage of PDT~     with regard to relief of jaundice, quality of life, and survival.~      In photodynamic therapy (PDT) the uniform distribution of externally applied light is~     desirable but often difficult to achieve. An optical fiber tip producing cylindrical or~     lateral light emission can facilitate the application of laser energy by direct implantation~     of the tip into solid tumors. However, currently used FDA approved glass diffusers used in~     standard of care PDT might break in the bile ducts causing injury since they are not meant to~     be used within bile ducts through an endoscope or choledochoscope. Hence, there is a need to~     evaluate and introduce more efficient and safe non-glass cylindrical optic fiber diffuser for~     photo dynamic therapy in the bile ducts. Recent studies have shown that the Pioneer plastic~     optic diffuser is safe and effective in photodynamic therapy, it can be also used via a~     choledochoscope. We aim to add to the clinical evidence by conducting an open label~     observational study trial using this fiber optic diffuser during photo dynamic therapy in the~     bile ducts.~   "
138456|NCT01755000|"~     The purpose of this study is to test how practical it is to use the Ultrasonic Cardiac Output~     Monitor (USCOM), an FDA-approved device, on oncology patients (specifically those with blood~     cancers). Additionally, the researchers will learn if the USCOM gives additional information~     about patients' conditions when their blood pressures drop and they are treated with~     intravenous fluids.~   "
138457|NCT01754987|"~     This protocol is a phase I/II, study of ascorbic acid (AA) infusions combined with treatment~     with sorafenib versus treatment with sorafenib alone in subjects with metastatic~     hepatocellular carcinoma. The phase I aspect will assess the safety and efficacy of the~     concurrent treatments and the phase II aspect will utilize CT (computer-tomography) scans to~     assess overall tumor response rate and evaluate disease progression~   "
138458|NCT01754974|"~     The purpose of this study is to determine if 48 weeks of therapy with Peginterferon Lambda~     plus Ribavirin is effective and safe for a treatment of chronic hepatitis C (CHC) compared to~     therapy with Peginterferon alfa-2a plus Ribavirin.~   "
138459|NCT01754961|"~     Chronic liver diseases are associated with inflammation. The investigators postulate that~     Vitamin D may modulate inflammation. Thus the investigators will study the effect of Vitamin~     D replacement in patients with Hepatitis C infection and Vitamin D deficiency.~   "
138460|NCT01754948|"~     Background Ambient airborne particulate material (PM) is defined according the aerodynamic~     diameter into coarse, fine, and ultrafine or nano sized particles ranging between 2.5-10 µm~     (coarse), <2.5 µm (fine), and <0.1 µm (nano(. Many studies have examined particle effect on~     respiratory health in children, mainly by environmental monitoring of coarse and fine~     particles. Biological assessment of individual exposure to nano sized particles in~     correlation to adverse health effect was not previously studied.~      Hypothesis individual exposure to nano sized particles in children is associated with~     reduction in forced expiratory volume at one second.~   "
138461|NCT01754935|"~     The current study is designed to evaluate the safety and efficacy, including MRI imaging,~     across a range of VX-509 doses in subjects with active rheumatoid arthritis (RA) who have had~     an inadequate response to disease-modifying antirheumatic drugs (DMARDs).~   "
138462|NCT01754922|"~     Following deployment to Operations Enduring and Iraqi Freedom and Operation New Dawn~     (OEF/OIF/OND), Veterans report breathing problems, difficulty exercising and other symptoms.~     These symptoms may be related to deployment exposures, such as regional dust and sand, smoke~     from burning trash, and local industry. Studies have reported poor air quality, but very~     little is known about the effect that exposure to this polluted air may have on Veterans'~     short- and long-term health. Investigators will determine whether deployment-related~     exposures have affected respiratory and nervous system function in these Veterans - data that~     may then be used to guide rehabilitation. Ultimately, the investigators' long-term goal is to~     prevent the development of chronic respiratory conditions in this group of OEF/OIF/OND~     Veterans.~   "
138786|NCT01750697|"~     This Phase IIa international multicenter, open-label, uncontrolled study will evaluate the~     safety and pharmacokinetics of rituximab (MabThera/Rituxan) in pediatric participants with~     severe granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA). Participants~     will receive rituximab 375 milligrams per square meter (mg/m^2) intravenously (IV) on Days 1,~     8, 15 and 22.~   "
138463|NCT01754909|"~     This project will test the effect of enalapril to mitigate the lung damage that can occur as~     a side effect of radiation therapy for lung cancer or other intrathoracic cancers. Thousands~     of Veterans develop lung cancer every year, and are treated by radiation therapy. Studies of~     lung radiation injury in laboratory animals show that with enalapril, investigators can~     significantly reduce the severity of radiation injury to the lung. Enalapril is FDA approved~     and in common use for treatment of hypertension, kidney disease, and heart failure. These~     studies will advance that work to human use. Successful mitigation of lung radiation damage~     will improve the quality of life in Veterans and non-Veterans who are treated for lung cancer~     by radiation, and may also improve cure rates of radiation therapy for lung cancer.~   "
138464|NCT01754896|"~     Prior to implementation of new colorectal cancer (CRC) screening technology (fecal~     immunochemical test - FIT) in Ontario, there is a need for a laboratory and field assessment~     to validate and optimize its use in the Ontario climate and conditions (e.g., large~     geographic area) and to determine whether adjustments to the current structure of the~     ColonCancerCheck (CCC) Program would be required.~      This study consists of 2 phases. Phase 1 consists of laboratory testing of FIT kits to~     evaluate analytical performance relevant to the requirements of the CCC Program. Phase 2 is a~     field assessment to evaluate the effect of different distribution and return methods and~     pre-labeling of kits on uptake and completion of the tests. The entire study will take 12-18~     months to complete, with patients being recruited through family physicians in patient~     enrollment model (PEM) family practices across the province of Ontario.~      This Clinical Trials registration relates to Phase 2 of the study.~   "
138465|NCT01754883|"~     The purpose of this study is to explore the effectiveness of adding lithium carbonate~     (lithium) to treatment for combat-related post traumatic stress disorder in combat veterans.~     The goal of this study is to establish that lithium is a practical and tolerable treatment~     option for veterans with combat posttraumatic stress disorder.~   "
138466|NCT01754870|"~     CLL/SLL is an incurable disease with conventional chemotherapy, and there are limited~     treatment options available for patients who have become refractory to fludarabine- and~     alkylating-agent based regimens. Bendamustine is a recently FDA-approved agent with~     significant activity in CLL/SLL, including significant activity in the setting of~     fludarabine-refractory disease. However, durations of remission following~     bendamustine/rituximab combination therapy tend to be short in patients with heavily~     pre-treated disease or who have already received rituximab.~      The incorporation of a maintenance therapy to overcome the shorter remission durations in~     this population is a reasonable and feasible option. In considering potential options for~     treatment of CLL/SLL as a maintenance strategy following induction chemotherapy, lenalidomide~     and rituximab are appealing options based on their convenient dosing schedules and recent~     evidence of acceptable toxicity and promising efficacy in combination therapy.~   "
138467|NCT01754857|"~     The investigators propose a treatment strategy where patients are treated with induction~     chemoimmunotherapy consisting of rituximab + bendamustine for 6 cycles, followed by~     initiation of maintenance rituximab and lenalidomide among patients achieving an objective~     response (i.e., at least stable disease with some tumor shrinkage) to induction therapy. The~     goal of maintenance therapy will be to capitalize on the cytoreduction following induction~     chemotherapy with a maintenance regimen that has also shown promising activity in CLL, in~     order to allow for improved PFS in this population.~   "
138468|NCT01754844|"~     This is a First in Human study to assess the safety and tolerability of AZD7624, following~     inhaled administration of single ascending doses in healthy male volunteers and female~     volunteers of non-child bearing potential. Pharmacokinetics (what the body does to the drug)~     and pharmacodynamic (what the drug does to the body) parameters will be also assessed as~     secondary objectives.~   "
138469|NCT01754831|"~     The specific aim of the study is to determine the excess urinary fluoride and its time course~     after administration of an application of Premier Enamel Pro Varnish to the teeth of 12-15~     month old infants. From these data the investigators can estimate the bioavailable (more~     precisely the equivalent) dose of sodium fluoride and the peak serum fluoride concentration~     that will allow an estimate of the margin of safety of the procedure.~   "
138470|NCT01754818|"~     The purpose of this study is to assess the study medication blood levels after administration~     of a single oral capsule of Bendavia at one of three dose levels. The effects of Bendavia on~     the volunteers will also be assessed.~   "
138471|NCT01754805|"~     A drug interaction study to evaluate the effect of ASP015K (twice daily) on the~     pharmacokinetics (PK) of once weekly oral methotrexate (MTX).~   "
138472|NCT01754792|"~     The purpose of this study was to assess whether pinitol improves hidrocarbonated metabolism~     parameters, and evaluate its effect on oxidative stress and endothelial function in diabetic,~     impaired and normal fasting glucose subjects.~      This was a 3-month randomised, controlled-placebo, parallel trial with a three-arm design.~     Patients were divided into three groups: diabetic (n=40), impaired fasting glucose (n=40) or~     normal fasting glucose subjects (n=40), receiving 4 g/day of pinitol/placebo.~   "
138473|NCT01754779|"~     The investigators will examine in two studies whether citric acid or potassium citrate can~     reduce calcium phosphate saturation in urine of Calcium Phosphate stone formers.~   "
138474|NCT01754766|"~     This study will evaluate the safety and efficacy of AGN-229666 for the treatment of allergic~     conjunctivitis.~   "
138499|NCT01754441|"~     Spinal muscular atrophy is a genetically based disease that affects motor neurons in the~     spinal cord and leads to muscle wasting and weakness. The gene found to be responsible for~     the underlying disease is called the SMN or survival motor neuron gene. Individuals with SMA~     are either missing a copy of the gene or have a mutation in the gene. Although the gene has~     been identified, how it actually causes the motor neurons to die and leads to muscle wasting~     and weakness is not completely understood. The investigators have found that skin cells from~     children with SMA tend to be more susceptible to cell death when exposed to cell death~     inducing agents. In this protocol, The investigators wish to study the mechanisms by which~     these cells die when exposed to these agents and how this may be related to the gene defect~     and the disease.~   "
138500|NCT01754428|"~     The purpose of this study is to collect clinical outcome and nasal viral load information.~   "
138501|NCT01754415|"~     The aim of this study is to evaluate the effect of hydraulic resistance circuit training for~     elderly people with chronic illness.~   "
138475|NCT01754753|"~     The National Institute for Health Research commissioned this research with the following~     research question: What is the relative effectiveness and cost effectiveness of home based~     support programmes in improving the mental wellbeing of older people living in their own~     homes?~      The project will evaluate whether telephone friendship groups, delivered by the voluntary~     sector over the telephone, can improve the mental wellbeing of older people aged 75 or over.~      The research will also:~        1. Identify the psychosocial and environmental factors, as well as implementation issues~          that may mediate or modify the effectiveness of the intervention using qualitative~          methods. This will include examining: 1.1. Assess voluntary sector readiness to take~          forward new forms of services; 1.2. The best modes of delivery of telephone~          support/friendship; 1.3. Assess how volunteers (facilitators) can be supported and~          retained; and, 1.4. The extent to which fidelity of the intervention is maintained~          within and across the participating organisations.~        2. Determine if there is any lasting impact upon mental wellbeing by repeat measurement~          with all participants 12 months following baseline measurement~        3. Examine whether there is any significant improvement on the physical dimension of the~          SF-36 at 6 months and 12 months, following baseline measure, for the intervention arm~          compared with usual care.~        4. Measure the extent of use of health and social care, and community facilities by~          participants over time to determine whether the intervention is cost effective compared~          with usual care.~   "
138476|NCT01754740|"~     Objectives: to evaluate xerostomia and salivary flow in patients with burning mouth syndrome~     (BMS) treated with amitriptyline before and after the use of antixerostomic topical~     medication.~      Methods: In this case-control double-blinded study, we enrolled 38 patients with BMS~     diagnosed according to the (IASP). The subjects were randomly divided into two groups: Study~     Group: 19 patients whom received topical medication of urea 10% and Control Group: 19~     patients whom received placebo to apply at the oral cavity 3-4 times per day, during three~     months. The patients were evaluated before and after the above treatment. Finally, data were~     statistically analyzed.~      It is know that BMS is eventually associated to reduced salivary flow (Cho et al.,2010; Kho~     et al., 2010; Marino et al., 2010) and to abnormal salivary composition (increasing~     concentrations of K+, Na+, Cl-, Ca+2, IgA, amylase) (Patton et al., 2007). Even in the~     absence of hyposalivation, patients may complain of xerostomia and dry mouth (Cho et~     al.,2010; Kho et al., 2010; Marino et al., 2010; Thomson, 2005). These patients also have~     several sensory losses even in taste and smell function, recently described (Siqueira et al.,~     2006a; Siqueira et al., 2006b; Siviero et al., 2011).~   "
138477|NCT01754727|"~     The purpose of this study was to assess the proportion of AS patients achieving treatment~     response to adalimumab therapy.~   "
138478|NCT01754714|"~     Investigation the Effects of Different Doses of SAMe in Subjects with Nonalcoholic Fatty~     Liver Disease and non-treated matched healthy volunteers as control group~   "
138479|NCT01754701|"~     The purpose of this study is to determine whether iron therapy given to iron-deficient~     Ugandan children with moderate-to-severe anemia and clinical malaria is better absorbed and~     incorporated into red blood cells if it is given concurrently with antimalarial treatment on~     Day 0 (immediate group) or 4 weeks after antimalarial treatment on Day 28 (delayed group).~     Use of iron stable isotopes 57Fe and 58Fe will permit measurement of red blood cell iron~     incorporation on Day 0 and Day 28 in all children. The investigators hypothesize that red~     cell iron incorporation at the time of initial supplement administration will be greater in~     children receiving delayed vs. immediate iron (Aim 1), and children in the delayed group will~     also have greater hematological recovery on Day 56 than children in the immediate group (Aim~     2).~   "
138480|NCT01754688|"~     The investigators hypothesize that a new BIND (Bilirubin Induced Neurologic Dysfunction)~     scoring method adapted for the developing world (BIND II, developed by our team for use by~     health care workers), with additional modifications for community use (the community BIND,~     C-BIND), will improve the ability to identify infants with ABE and to distinguish ABE from~     other common causes of neonatal morbidity and mortality compared to currently available~     survey tools.~   "
138481|NCT01754675|"~     Watching football matches could cause increased blood pressure and heart rate induced by~     catecholamines and thus increase the incidence of cardiovascular events. However, no studies~     have evaluated the responses of blood pressure and heart rate in soccer spectators.~      This study evaluates the hemodynamic response in Brazilian soccer fans suffering from~     coronary artery disease during a dispute over a game of your favorite team.~   "
138482|NCT01754662|"~     Diabetes is an increasingly common condition affecting millions of people world wide. The~     cornerstone of treatment is lifestyle that includes looking at the way how people eat. It is~     known that food containing compounds called polyphenols can reduce the risk of heart disease~     risk in people with diabetes. Two foods that are rich sources of polyphenols are cocoa~     (epicatechins) and soy (isoflavones). Previous studies have shown the benefits of these foods~     in the diets of people with diabetes. It has also been shown that soy isoflavones and cocoa~     polyphenols can improve the mood in certain groups of patients.~      What is not known is whether there is any extra benefit of combining soy protein and~     isoflavones with cocoa.~      The aim of the study is to look at the modification of cardiovascular risk by soy and/or~     cocoa in patients with type 2 diabetes, alone or in combination.~   "
138483|NCT01754649|"~     To assess the usefulnes sof misoprostol versus placebo (in a double-blind placebo controlled~     randomized clinical trial)to facilitate the insertion of copper-IUD and the~     levonorgestrel-releasing intrauterine system (LNG-IUS) in cases of failure due to cervical~     stenosis in either nulligravidas and parous women. Additionally to evaluate the side-effects~     of the misoprostol. The hypothesis is that misoprostol may be better than placebo.~   "
138502|NCT01754402|"~     This study is designed as a phase I-II, open label, dose finding study.~      Study treatment will be as follows, in 28 day cycles:~        -  Pomalidomide: once daily orally (PO) dosing on days 1-21, every 28 days~        -  Bendamustine: once intravenously (IV) dosing on day 1, every 28 days~        -  Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22.~      After completing 6 cycles of treatment, dexamethasone may be decreased to 20mg per~     investigator discretion. After completing 12 cycles of treatment, patients will proceed to~     the maintenance phase of the study. Patients will receive Pomalidomide on day 1-21, every 28~     days and dexamethasone on days 1, 8, 15, and 22 every 28 days until time of progression.~   "
138484|NCT01754636|"~     Background: Inadequate representation of elderly cancer patients in randomized clinical~     trials (RCTs) leading to a lack of external validity thereby an uncertainty regarding~     benefit-risk balance of cancer treatment in elderly, especially chemotherapy.~      Hypothesis: The eligibility criteria explain only a part of the under-representation of~     elderly patients in trials. We make the assumptions that 1) Among the eligible, the~     invitation to participate in a trial and inclusion are inversely related to age, 2) Among the~     eligible, there are patients, practitioner, or organization factors that would explain the~     non inclusion of elderly patients.~      Objectives:~      1) To assess, in elderly patients with colorectal cancer, the proportions of patients:~        1. eligible at least to one RCT~        2. invited to participate~        3. included 2)~      a) Compare proportions among elderly patients to those of the comparator group of young~     subjects (age ≥ 18 and <65 years) (added by amendment n°3 accepted 18/02/2014) b)To identify~     factors associated with the non-invitation and the non-inclusion in RCT.~      Material and methods:~      Study design: A multicentric prospective cohort survey Population: all patients aged 18 years~     or more (added by amendment n°3 - 02/2014) with a colorectal cancer followed in one of the~     participating centers.~      Data collection:~        -  At baseline: Patient characteristics (including SOCIO-demographic, oncologic and~          geriatric data) will be collected. Organization factors (e.g. clinical research team)~          will be collected.~        -  Follow-up: the patient will be followed for potential invitation and inclusion in one~          RCT. Reasons of non-invitation or non-inclusion will be assessed.~      Number of subjects needed: 696 (553 elderly patients and 143 young patients) Number of~     centers : 7 (added by amendment n°3 - 02/2014)~      Ethical aspects: each patient will give his oral informed consent. The International Review~     Board of Mondor Hospital (CPP Ile-de-France IX) gave its approval in December 2012.~   "
138485|NCT01754623|"~     The purpose of this study is to find out if a program of intensive chemotherapy with~     gemcitabine, docetaxel and capecitabine followed by an advanced form of focused radiation~     aimed at participant's tumor followed by more chemotherapy can increase the chances that the~     participant's pancreatic tumor can be removed completely.~   "
138486|NCT01754610|"~     Strengthening Families Coping Resources (SFCR) Open Trials completes the second stage of the~     National Institute on Drug Abuse's intervention development model by testing a new family,~     skills-based intervention involving pre-post evaluation of families participating in~     multi-family groups. The purpose of this study is to gather practice-based evidence on the~     effectiveness of the manualized treatment, on the dynamics involved in the group format, and~     on implementation fidelity and feasibility. Analyses will involve initial exploration of the~     following hypotheses: 1) Families will show a significant increase in the constructive use of~     family coping skills and in general family functioning. 2) The target child will show a~     reduction in trauma-related symptoms and behavior problems. 3) Families will engage and~     participate in the treatment. 4) Providers will implement SFCR with fidelity.~      Other outcomes of interest are the process measures that will be collected to monitor~     participation in the groups, cultural sensitivity and acceptability, clinician competence,~     and intervention integrity.~   "
138487|NCT01754597|"~     The cardiotoxicity of anthracyclines chemotherapy remains a major problem, despite clinical~     and echocardiographic monitoring. In the case of treatment for breast cancer, surgery~     requiring general anesthesia may follow chemotherapy. Although a possible interaction between~     general anesthetics and anthracyclines on systolic function is only rarely mentioned, some~     cases of heart failure and / or conduction disturbances peranesthésique were observed in~     patients treated or previously treated with anthracyclines. The determination of~     concentration of BNP is a diagnostic tool used in the detection of heart failure and acute~     coronary syndromes. The question of a possible synergism between cardiotoxic anthracyclines~     and anesthetic agents arises. Given its minimally invasive nature and its diagnostic value,~     the BNP assay might thus allow to highlight a possible subclinical deficiency. To our~     knowledge, there is very little data regarding a possible synergism between cardiotoxic~     anthracyclines and anesthetic agents.~   "
138488|NCT01754584|"~     The mucociliary system of nasal mucosa, which is composed of the ciliated respiratory~     epithelium, the mucous blanket, and the mucus-producing glands, is an important defense~     component of the respiratory system. Therefore, it is important to maintain intact inner~     respiratory mucociliary epithelium in reconstruction of large respiratory defect and in the~     development of tissue engineering trachea. Hyaluronan derivatives, which are biodegradable~     and non-immunogenic, have already proved to be effective as a scaffold for chondrocytes.~     However, the feasibility of use as a scaffold for respiratory epithelial cells remained~     unexplored. The aim of the study is to investigate the effect of hyaluronan including~     concentrations and molecular weight on the mucociliary differentiation of human respiratory~     epithelial cells (HREC). If hyaluronan is able to promote mucociliary differentiation of~     HREC, the investigators can synthesize hyaluronan derivatives serving as ideal biomaterials~     for respiratory tissue engineering and tissue-engineered trachea in the future.~   "
138489|NCT01754571|"~     According to the definition from International Headache Society, medication overuse headache~     (MOH) is diagnosed when patients takes painkillers for more than 10 or 15 days per month~     (depending on what kind of painkillers being used), for more than 3 months, which results in~     the deterioration of headache. The treatments of MOH include preventive medication of~     headache and withdrawal of the overused painkillers. Other than the simple oral advice, some~     researchers recommended non-pharmacological methods. Pryse-Phillips et al. (1998) reviewed~     the the treatment of migraine and suggested that biofeedback, relaxation, cognitive behavior~     therapy (CBT), psychological therapy, hypnosis and physical treatment are effective.~     Researches also point out CBT is effective on withdrawing medication in patients with MOH~     (Kroner-Herwig, 2009). Lake (2006) reported that behavioural therapy maybe an adjunct therapy~     to preventive medication to reduce the relapse rate of medication overuse.~      The purpose of this study is to confirm the effect of CBT in patients with MOH. The target is~     to reduce the frequency of headache and use of painkillers. Patients could benefit from the~     education and relaxation training during CBT to cope with headache and reduce the use of~     painkillers.~      The research will recruit 60 patients with MOH at Neurology Clinics, Far Eastern Memorial~     Hospital. They will be separated into two groups, 30 in control group and the other 30 in the~     experimental group. Education of MOH, relaxation and cognitive restructuring would be~     included in the four weeks training program. The training program is under the supervision of~     a neurologist from Far Eastern Memorial Hospital and a psychology professor from Fu Jen~     Catholic University. The control group will accept four weeks telephone interview to confirm~     their headache diary including the frequency of headache and use of painkillers. The~     frequency of headache and medication use will be used for analyzing the effect of CBT.~   "
138522|NCT01754142|"~     The purpose of this post-marketing surveillance is to investigate and confirm the type and~     incidence of newly identified adverse events and any other factors affecting safety and~     efficacy of Kombiglyze Extended release (XR) so that the regulatory authority can manage the~     marketing approval properly~   "
138541|NCT01753895|"~     Blood pressure (BP) measurement is one of the most commonly performed screening tests in the~     clinical setting. Its accuracy is vital to the early diagnosis and effective management of~     hypertension, as emphasized by hypertension management guidelines. For most protocols being~     conducted in a clinical research setting, obtaining single or serial blood pressure~     reading(s) is often performed as a safety assessment, especially if the individual is~     participating in a study that requires a blood draw and/or the administration of a research~     drug, vaccine or device. It is imperative that the blood pressure data truly reflect the~     response, if any, the study participant experiences in relation to the research procedures~     and interventions.~   "
138490|NCT01754558|"~     During the last decade numerous new procedures have been presented regarding surgical~     treatment of urinary stress incontinence (1,2). Development of the midurethral tape procedure~     (TVT) changed the surgical procedure dramatically both regarding the extent of the surgical~     procedure and also decreased the morbidity remarkably. The success rate of the TVT procedure~     has been proven to be high (1,2 ). However, the development of the TOT/TVT-O procedures~     disclosed a new fixation point and further decreased the risk of bladder injury (1,2). Since~     the introduction of trans-obturator slings several mini-slings have been introduced in order~     to reduce the need of perforation of the skin and muscles (3,4,5). Although some systems seem~     promising (5) others have disclosed a long learning curve, pain problems following the~     procedure and lower success rates, compared to the traditional sling procedures. None of~     these mini-slings have been adjustable.~      Recently the Ajust system for treatment of stress urinary incontinence was introduced. The~     system is a single incision sling procedure and consists of an adjustable Polypropylene mesh~     sling with self fixation anchors (6). In a feasibility study (6), the 6 months objective cure~     rate was 82%, but there is a lack of information regarding adverse events and durability of~     treatment success. Our preliminary experiences suggest, that the procedure has a rapid~     learning curve, low pain scores postoperatively and a 94% cure rate at 3 months follow-up~     (personal observation). Recently, several abstracts have indicated that the cure rate~     obtained by Ajust is comparable to TVT or TVT-O (10-12).~      The purpose of the present study is (primary outcome):~      To test the hypothesis that the Ajust and TVT, TVT-O and TOT, respectively are equal~     regarding subjective cure rate (cure is defined as subjectively not incontinent at all), i.e.~     the study is designed as a non-inferiority study. The study is performed as a randomised~     controlled trial without blinding. The study is powered to detect a 9% difference between the~     two groups. The subjective cure rate is based on ICIQ measurement~      Secondary outcome:~        -  To test the hypothesis that Ajust is associated with a significantly lower postoperative~          pain perception.~        -  To test the hypothesis that antibiotic treatment is not necessary~   "
138491|NCT01754545|"~     Congenital thrombotic thrombocytopenic purpura (TTP), also called Upshaw-Schulman Syndrome or~     hereditary or familial TTP is a rare, but severe disease. The purpose of this study is to~     determine how infusions of plasma to patients with congenital TTP correlate with symptoms and~     signs of activity of the disease, and to determine why some patients need more frequent~     infusions of plasma than others to prevent acute attacks of the disease.~   "
138492|NCT01754532|"~     The importance of stress as a possible deteriorating factor for schizophrenic patients is~     well documented. However, this notion is based on subjective experience and retrospective~     psychological analysis.~      A novel method of measuring cortisol using hair has a proven correlation to subjective stress~     in non-clinical as well as psychiatric clinical populations.~      This pilot study will attempt to assess the use of cortisol hair level, as a marker of~     stress, to predict clinical deterioration in schizophrenic patients.~   "
138493|NCT01754519|"~     This phase II trial studies how well radiation therapy works in treating post-menopausal~     women with early stage breast cancer undergoing surgery. Radiation therapy uses high energy x~     rays to kill tumor cells. This may be an effective treatment for breast cancer.~   "
138494|NCT01754506|"~     The purpose of this study is to test the efficacy of an oral, nutrient intervention~     containing the bioactive components of fish oil to promote healing of chronic venous leg~     ulcers (CVLU). If this systemic, nutrient intervention is found to alter the microenvironment~     of CVLU, the science of wound healing and care of patients with CVLU will be vastly improved.~   "
138495|NCT01754493|"~     This study will evaluate the efficacy of duloxetine in reducing depressive symptoms,~     abdominal pain, and other symptoms of Irritable Bowel Syndrome (IRS) in a population of~     outpatients with Major Depressive Disorder MDD and clinical symptoms of IBS.~   "
138496|NCT01754480|"~     This study is designed to assess the safety and efficacy of Fibrin Sealant Grifols in~     patients undergoing open surgical procedures where bleeding may be present on parenchymous~     tissue (e.g., solid abdominal organs such as the liver). The purpose of this study is to~     demonstrate that Fibrin Sealant Grifols is not inferior to commercially-available oxidized~     cellulose pads (Surgicel®) in providing benefit in the time to hemostasis (i.e, the stoppage~     of bleeding). This study has a Preliminary Part (I) for study teams to become familiar with~     the application of Fibrin Sealant Grifols and to assess safety and a Primary Part (II) to~     assess the safety and efficacy of Fibrin Sealant Grifols. In both parts of the study,~     patients will be randomized in a 1:1 ratio to either Fibrin Sealant Grifols or Surgicel.~   "
138497|NCT01754467|"~     Sedentary behavior is associated with an increased risk of mortality and many health~     conditions including type 2 diabetes, obesity, cardiovascular disease, and metabolic~     syndrome, independent of the time spent in moderate-to-vigorous intensity physical activity~     (MVPA). Furthermore, independent of total sedentary time and MVPA, Healy et al. observed that~     individuals who had more breaks in sedentary time had lower 2-h plasma glucose. Recent~     experimental findings also suggests that breaking up prolonged bouts of sedentary behavior (≥~     20 minutes) with either light or moderate intensity activity for 2 minutes reduces~     postprandial glucose and insulin responses.10 Replacing sedentary time with light-intensity~     activity or nonexercise activity thermogenesis (NEAT) may help to reduce the health~     consequences of sedentary behavior. The purpose of this study is to develop a smartphone~     application (NEAT!) to encourage sedentary adults with diabetes to increase breaks in~     prolonged bouts of sedentary behavior objectively measured by an accelerometer. NEAT! will be~     refined by modifying technology created for the ENGAGED trial (RC1DK087126) and will work in~     conjunction with a Bluetooth enabled accelerometer that can detect bouts of sedentary~     behavior. When a sedentary bout (≥ 20 minutes) is detected, the smartphone application will~     trigger a reminder prompt to the user encouraging him/her to participate in NEAT for at least~     2 minutes. Following the development, testing, and refining of the application, a sample of~     10 sedentary adults with type 2 diabetes will be recruited to participate in a one month~     trial to examine the feasibility and acceptability of NEAT!. To our knowledge, this is the~     first study to design and examine the acceptability of a smartphone application that will~     target interrupting sedentary behavior with NEAT using objectively measured sedentary time in~     a diabetic population.~   "
138498|NCT01754454|"~     Allogenic haemopoietic stem cell transplantation (allo-HSCT) is the treatment for many~     malignant and non-malignant hematologic disorders. Acute graft-versus-host disease (aGVHD) is~     a serious life-threatening complication after allo-HSCT. The outcome for patients with aGVHD~     is poor and overall survival is low. Acute graft-versus-host disease (GVHD), as the major~     complication of allogeneic peripheral blood stem cell transplantation(PBSCT), limits the~     application of this curative therapy. Mesenchymal stem cells (MSCs) are multipotent stem~     cells, which are able to modulate immune response in vitro and in vivo, and have~     possibilities of treating diseases caused by immune dysregulation such as aGVHD. MSCs~     obtained from umbilical cord (UC) have similar immunosuppressive properties as bone~     marrow-MSCs. In addition, UC-derived MSCs can be used for off-the-shelf use and are obtained~     without any harm to donors than bone marrow-MSCs. Therefore, the investigators designed this~     study to evaluate the safety and efficacy of UC-derived MSCs in patients with aGVHD.~   "
138555|NCT01753713|"~     This phase II trial studies how well dovitinib works in treating patients with recurrent or~     progressive glioblastoma. Dovitinib may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth~   "
138556|NCT01753700|"~     The studie are to investigate the effect of ultra heat treated (UHT) versus pasteurised milk~     on bloodlipid profile~   "
138787|NCT01750684|"~     To determine safety and tolerability of AC105 following a regimen of 6 intravenous doses over~     30 hours in patients with acute non-penetrating traumatic spinal cord injury (SCI).~   "
138503|NCT01754389|"~     This research study is a Phase II clinical trial. Phase II clinical trials test the~     effectiveness of an investigational drug to learn whether the drug works in treating a~     specific cancer. Investigational means that the drug is still being studied and that~     research doctors are trying to find out more about it-such as the safest dose to use, the~     side effects it may cause, and if the drug is effective for treating different types of~     cancer. It also means that the FDA has not yet approved bortezomib to treat or prevent~     graft-versus-host disease. Bortezomib is approved by the FDA to treat other human~     malignancies.~      Bortezomib is a drug that has an anti-cancer effect that involves inhibiting cell growth and~     causing cell death. This drug has been used in other research studies, and information from~     thos other research studies suggests that bortezomib may help to lower the risk of GVHD after~     allogeneic stem cell transplantation in patients who have matched unrelated, unmatched~     related or unrelated donors in this research study.~      Allogeneic stem cell transplantation is a procedure in which selected blood cells taken from~     your sibling or unrelated donor are given to you. Lower doses of chemotherapy drugs are given~     before the donor cells are infused in a process known as reduced-intensity conditioning. Stem~     cell transplant destroys cancer in two ways: The conditioning regimen destroys cancer cells~     and teh immune cells from the donor can recognize cancer cells and kill them.~      A common problem after stem cell transplant is graft-versus-host disease (GVHD). The word~     graft refers to the donor blood cells that you will receive during your transplant. The~     word host refers to the person (in this case, you) receiving the cells. GVHD is a~     complication of transplantation where the donor graft attacks and damages some of your~     tissues. GVHD can cause skin rash, intestinal problems such as nausea, vomiting or diarrhea.~     GVHD may also damage your liver and cause hepatitis or jaundice. GVHD may also increase your~     risk of infection.~      After stem cell transplant, all patients receive prophylactic medications against GVHD. In~     this research study we are studying the safety and effectiveness of preventing GVHD using~     bortezomib treatment in combination with other drugs versus standard of care prophylaxis~     (tacrolimus + methotrexate). If you take part in this study, there is a 33% chance you will~     receive any one of the following GVHD prevention treatments:~        -  tacrolimus + methotrexate (standard of care GVHD prophylaxis)~        -  bortezomib + tacrolimus + methotrexate~        -  bortezomib + sirolimus + tacrolimus Sirolimus, tacrolimus and methotrexate are drugs~          that suppress the immune system to try to prevent GVHD.~   "
138504|NCT01754376|"~     This research study is a Phase II clinical trial of an investigational combination of drugs~     (vemurafenib and aldesleukin) to learn whether the combination works in treating a specific~     cancer. While both vemurafenib and aldesleukin are approved by the FDA for the treatment of~     metastatic melanoma, the FDA has not yet approved the combination of vemurafenib and~     aldesleukin.~      Researchers have found that a large number of melanoma cells have mutations in the BRAF gene.~     It has been shown that vemurafenib blocks the effects of these mutations in the BRAF gene,~     and, as a result, may help to prevent cancer growth.~      Aldesleukin, also referred to as IL-2, is an immunotherapy drug administered via IV infusion~     that increases the growth of key cells within the immune system that are responsible for~     targeting cancer cells. Activating more of these key cells, called T-lymphocytes and~     natural-killer cells, leads to increased cancer cell death.~      The BRAF gene is located on a larger pathway called the MAPK pathway. Studies have shown that~     when a BRAF inhibitor, like vemurafenib is used to block the MAPK pathway, melanocytes, or~     cancer cells express more proteins on their surfaces, making them easier for T-lymphocytes~     and natural killer cells to recognize and kill them. This suggests that combining~     BRAF-targeted therapy with aldesleukin, which activates more of these white blood cells, can~     lead to an increase in the death of cancer cells.~      In this research study, the investigators are looking to see whether the combination of~     vemurafenib (a BRAF-inhibitor) combined with aldesleukin(an immunotherapy drug) work together~     to produce a better health outcome in people with metastatic melanoma.~   "
138505|NCT01754363|"~     This post-marketing investigation will evaluate the long term (up to 15 years) survivorship~     of the Attune Primary Knee Prosthesis in patients with non-inflammatory degenerative joint~     disease. Data from Subjects who receive one of four knee configurations will be pooled to~     establish a contemporary dataset.~   "
138506|NCT01754350|"~     Increased glucose metabolism is characteristic for solid tumors. Thereby, glucose is~     important for the generation of ATP, supply of anabolic substrates and defense against~     reactive oxygen species in tumor cells. In preclinical models, restricting glucose~     availability using a ketogenic diet, calorie-restriction or transient fasting inhibits tumor~     growth.~      Therefore, the purpose of the study is to evaluate whether a calorie-restricted, ketogenic~     diet and transient fasting can enhance the efficacy of reirradiation in patients with~     recurrent glioblastoma.~   "
138507|NCT01754337|"~     Closed-loop strategy is composed of three components: glucose sensor to read glucose levels,~     insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required~     insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would~     regulate glucose levels through the infusion of two hormone: insulin and glucagon.~      The main objective of this project is to compare the efficacy of single-hormone closed-loop~     strategy, dual-hormone closed-loop strategy and pump therapy to regulate glucose levels in a~     24-hours in-patient study with standardized conditions in adults and adolescents with type 1~     diabetes.~      The investigators hypothesized that dual-hormone closed-loop strategy is more effective in~     regulating glucose levels in adults and adolescents with type 1 diabetes compared to~     single-hormone closed-loop strategy, which in turn is more effective than the conventional~     pump therapy.~   "
138508|NCT01754324|"~     The chronic use of opiate medications during pregnancy is a major public health challenge.~     Prolonged exposure to opiates in utero may result in withdrawal symptoms in infants commonly~     referred to as neonatal abstinence syndrome (NAS). Signs of NAS may include irritability,~     high-pitched crying, muscle tightness, seizures, diarrhea, vomiting, poor feeding, and~     unstable body temperature. Many infants may be treated by supportive (non-pharmacological)~     therapy by minimizing stimulation, cuddling, responding promptly to hunger cues, and other~     comfort care. However, some infants continue to show severe symptoms of withdrawal despite~     these interventions. In these cases, infants may be treated with medications (pharmacological~     therapy). Although it has been several decades since the first descriptions of NAS, there~     still remains limited information with regards to the most effective treatment. We~     hypothesize that medical treatment protocols of NAS with methadone can be optimized by better~     understanding what the body does to the drug (the population-based pharmacokinetics of~     methadone).~   "
138539|NCT01753921|"~     This is a research study to understand how diabetic ketoacidosis may affect the brain and~     learning and to see if these changes are transient or permanent. The investigators hope to~     learn more about how diabetic ketoacidosis may cause changes in brain compliance (by wearing~     a non-invasive head band/helmet like device from Jan Medical: The Nautilus Neurowave System™~     (NNS), learning, talking, behavior, or development. The investigators will compare those~     results from those with diabetes mellitus to those age and gendered matched healthy controls.~     Possible subjects in this study have diabetes mellitus and are between the ages of 10 to less~     than 17 years old OR do NOT have diabetes and are between the ages of 10 to less than 17~     years old.~   "
140635|NCT01726504|"~     The main purpose of this study is to evaluate efficacy of electro-acupuncture for severe~     functional constipation compared with sham acupuncture, used as placebo; the secondary~     purpose is to evaluate the safety and post-treatment effect of electro-acupuncture.~   "
138509|NCT01754311|"~     Only 5 to 10% of patients infected with HTLV-1 develop a disease related to infection. The~     two most serious diseases are adult T-cell leukemia (ATL) and Tropical spastic paraparesis~     /HTLV-I-associated myelopathy (TSP / HAM). Factors influencing the development of TSP / HAM~     in the individual HTLV-1 are not yet completely understood. Patients TSP / HAM have a HTLV-1~     proviral load (amount of virus) that is 6-10 times higher than seropositive asymptomatic.~      Various studies have shown that the development of TSP / HAM in the subject HTLV-1 and its~     rapid evolution is partly attributed to the failure of the immune system that regulates viral~     replication and expression.~      It has recently been shown that different versions of Single Nucleotide (human leukocyte~     antigen) rs12979860, located upstream of the gene for Interleukin 28B (IL28B), influenced the~     severity of infection with hepatitis C and effectiveness of treatment.~      By analogy with hepatitis C, a Spanish (Treviño et al., 2012) examined this SNP(single~     nucleotide polymorphism) in 12 patients TSP / HAM and 29 asymptomatic HIV-positive. CT or TT~     genotype was statistically more frequent in the group TSP / HAM than in asymptomatic patients~     (80% versus 20%) and was associated with HTLV-1 proviral load higher.~      We propose a broader group of patients in our population and Afro-Caribbean, to confirm the~     results of the latter study was conducted in a predominantly Latin American population.~   "
138510|NCT01754298|"~     The purpose of this study is to compare the functional, clinical and radiographic outcomes~     associated with trans-articular drilling versus retro-articular drilling, two commonly~     employed techniques of operative treatment for stable forms of juvenile osteochondritis~     dissecans (JOCD) lesions. This study also aims to better define the natural history of this~     condition in its most commonly identified pathological state (as a stable lesion) following~     surgical intervention by determining the rate of radiographic healing and any need for~     secondary surgery.~   "
138511|NCT01754285|"~     This is a phase II, multicenter, double-blind, double-dummy, parallel-group,~     placebo-controlled, study to evaluate LF-PB versus placebo in female patients with brest~     cancer who are undergoing breast surgery with axillary lymphnode dissection.~      Recruited patients will be randomly assigned to one of the following treatment groups:~     Placebo, LF-PB 10 mg, LF-PB 20 mg and LF-PB 30 mg.~      Mode of administration is single intramuscular (IM) injection so the treatments arms are as~     follows:~      Placebo: 2 injections of placebo LF-PB 10 mg: 2 injections = placebo + 10 mg LF-PB 20 mg: 2~     injections = placebo + 20 mg LF-PB 30 mg: 2 injections = 10 mg + 20 mg~      The study will randomize a total of 120 patients (30 per arm) in about 10 Italian Sites.~   "
138512|NCT01754272|"~     This is a follow-on study to the VELOUR trial (NCT00561470). The aim of this study is to~     acquire the archived colorectal cancer and metastasized tissue tumour blocks of patients who~     have participated in the VELOUR study.~      These samples will be analysed to find proteins or markers which represent how an individual~     may be responding to treatment. The identification of these markers may help provide~     personalised and more effective treatment programs for patients with similar conditions in~     the future.~   "
138513|NCT01754259|"~     Coronary vascular dysfunction is highly prevalent among patients with known or suspected~     Coronary Artery Disease (CAD)1, increases the severity of inducible myocardial ischemia~     (beyond the effects of upstream coronary obstruction)2, and identifies patients at high risk~     for serious adverse events, including cardiac death1, 3-5. Diabetic patients without known~     CAD with impaired coronary vascular function show a risk of cardiac death comparable to, and~     possibly higher, than that for non-diabetic patients with known CAD10. In the setting of~     increased oxygen demand, coronary vasodilator dysfunction can upset the supply-demand~     relationship and lead to myocardial ischemia, subclinical left ventricular dysfunction~     (diastolic and systolic), and symptoms.~      The significance of microvascular coronary dysfunction is increasingly recognized as invasive~     and non-invasive (PET) methods of quantifying CFR become available.~      Importantly, current treatment strategies for obstructive CAD, such as percutaneous coronary~     intervention with angioplasty and stenting, are not helpful in microvascular disease.~     Similarly, mortality-altering treatments for systolic heart failure, such as angiotensin~     converting enzyme inhibitors, have not been beneficial in treating diastolic dysfunction.~   "
138514|NCT01754246|"~     The purpose of this study is to assess treatment for facial skin toning and removal of~     epidermal pigmented lesions for Asian patients using the 755nm Alexandrite laser~   "
138515|NCT01754233|"~     The purpose of this study is to assess treatment for facial dermal and epidermal pigmented~     lesions using the 755nm Alexandrite laser.~   "
138516|NCT01754220|"~     Montelukast, a leukotriene receptor antagonist, is likely to be effective in the treatment of~     chronic cough and this could be made objective by measuring cough threshold before and after~     two weeks of treatment.~   "
138517|NCT01754207|"~     The purpose of this study is to collect further data on the safety and efficacy of removing~     unwanted non cosmetic tattoos (including recalcitrant) using the 755nm Alexandrite laser.~   "
138518|NCT01754194|"~     Study objectives:~        1. generate local clinical, health-related quality-of-life and health economic data to~          evaluate the benefits of two types of minimally invasive weight-loss surgery~        2. support multi-disciplinary bariatric sites in Germany by providing structured procedure~          guidelines and training, therefore facilitating procedural adoption, increasing safety~          and shortening the learning curve for weight-loss surgery.~   "
138519|NCT01754181|"~     The main objective is to assess if the Diabeloop algorithm provides better glycemic control~     than a manual usual algorithm of patients with type 1 diabetes treated by insulin pump~     during meals, and during activity qualified moderate to severe by the patients.~      The study will be conducted in 18 patients. The investigation centers are: CHSF (for~     Diabeloop algorithm test during activity), CHU of Grenoble and CHU of Toulouse (for Diabeloop~     algorithm test during meals.~   "
138520|NCT01754168|"~     The investigators propose to study persons with Parkinson Disease (PD) with detailed~     clinical, cognitive and imaging at the time of study entry and repeat these assessments 2~     years later. The study looks at how changes in activity of the neurotransmitter acetylcholine~     relates to changes in cognitive function and to see if there is presence or build up of~     amyloid protein.~   "
138521|NCT01754155|"~     The purpose of this study is to use Radiostereometric Analysis (RSA) and clinical outcome~     measures to evaluate early, post-operative implant stability, post-operative implant~     fixation, clinical performance, and in-vivo wear of the Zimmer® Continuum® Cup with vitamin E~     stabilized polyethylene.~   "
138523|NCT01754129|"~     In patients with advanced levodopa-responsive Parkinson's Disease and severe motor~     fluctuations despite optimized treatment with conventional oral Parkinson's Disease~     medications, treatment with Duodopa represents an alternative treatment option to improve~     motor, non-motor performance and overall quality of life. These benefits have been obtained~     in short and mid-term trials (mainly up to 2 years). Data on long-term effectiveness (5 years~     of treatment or more) and safety are not available. Also data concerning the benefit of~     Duodopa on cognitive function, axial symptoms and disability have to be confirmed. Recent~     data on deep brain stimulation (DBS), the alternative option treatment in advanced~     Parkinson's Disease patients, showed that after 5 years from the implant, a worsening of~     axial symptoms (gait and balance) and after 1 to 3 years of speech could occur. Moreover, it~     has never been assessed if the benefit on motor and non-motor symptoms in patients treated~     with DUODOPA could be influenced by age and duration of the disease, as already shown for DBS~     implanted patients. This study should clarify the missing information on long-term benefit of~     Duodopa (up to 7 years) especially focusing on motor fluctuations and disability.~   "
138524|NCT01754116|"~     This is a single-center, randomized, open-label, 3 parallel treatment study in healthy adult~     subjects to assess the relative bioavailability of new formulations of GSK1265744 LAP 400 mg~     intra muscular compared to the current GSK1265744 LAP 400 mg nanomilled formulation. This~     study will evaluate LAP formulations of GSK1265744 with different particle sizes.~      Following a 14 day lead in period with oral GSK1265744, forty-five subjects will receive 400~     mg of one of three GSK1265744 formulations which vary in particle size from 200 nm to 5 um by~     intramuscular injection. Samples for determination of GSK1265744 concentrations will be~     collected for 12 weeks post-injection. Safety will be evaluated by adverse event recording~     and laboratory values at frequent intervals throughout the trial. A subgroup of 12 subjects~     will receive a 3 mg dose of oral midazolam at baseline on Day-29 and then again on the last~     day of the oral GSK1265744 lead in period to evaluate the effect of GSK1265744 on CYP3A~     enzymes.~      The subjects will undergo follow-up evaluations for a minimum of 12 weeks.~   "
138525|NCT01754103|"~     Brain plasticity of cortical activity caused by repetitive tactile stimulation could have a~     progressive development that was from primary parietal areas, passing over parieto-occipital~     areas and came secondary to primary occipital areas. This process allows to understand the~     existence of neurons in the brain and specific areas for certain functions independent of the~     type of stimulation is performed.~      By performing repetitive tactile stimulation over a period of 3 months,using a tactile~     stimulator, our group will try to prove several that repetitive tactile stimulation can~     create cross-modality and improve recognition and localization of patterns in blind people.~   "
138526|NCT01754090|"~     The purpose of this study is to test whether an online multi session alcohol intervention~     improves treatment effect compared to single session screening with feedback only.~      All participants in the trial received a single session screening procedure including~     individualized normative feedback (usual care). Additionally, half of the participants~     received a simple online booklet about the effects of alcohol. The other half received an~     online multi session follow up program.~   "
138527|NCT01754077|"~     The purpose of the proposed research is to evaluate the Thirty Million Words (TMW)~     Intervention through a randomized, controlled pilot study. The primary goal of the~     intervention is to enrich the early language learning environment of children from~     low-socioeconomic status (SES) backgrounds by targeting parent skills that relate to adult~     word input and conversational turn taking. The investigators hypothesize that receiving the~     TMW intervention will result in changes in parent behaviors.~   "
138528|NCT01754064|"~     SCORE is an active, prospective, non-randomized, multi-center outcome-oriented registry of~     patients implanted with St Jude Medical (SJM) market-released cardiac rhythm management (CRM)~     products. This registry will be conducted in the United States (US).~      The primary purpose of the registry is to evaluate and publish acute and long-term~     performance of market-released SJM CRM products by analyzing product survival probabilities.~     Product status and any related adverse events will be collected to measure survival~     probabilities.~   "
138529|NCT01754051|"~     This study is a prospective, multi-center registry of patients with intracranial aneurysms~     who are treated by the PC 400 System. Data for each patient are collected up to 12 ± 3 months~     post-procedure for the study.~   "
138530|NCT01754038|"~     This registry will perform prospective surveillance of participants attending collaborating~     Integrative Medicine clinic sites for clinical services. All decisions about medication use,~     treatments, visit frequency, assessment of tolerance, and other aspects of patient management~     will be left to the clinical providers' discretion. We will attempt to follow the~     participants in the PRIMIER Registry for up to 2 years.~      Essential data elements that capture patient-reported outcomes and measures of clinical~     activity will be obtained at approximately 2-month intervals for the first 6 months, then~     every 6 months through the end of year 2.~   "
138531|NCT01754025|"~     Lung cancer is a common malignancy that is associated with cigarette smoking but can also~     affect individuals who never smoked. It is not well understood whether there are hereditary~     risk factors that influence the risk of lung cancer.~      It has been recently found that a small number of families have an inherited (passed from~     parent to child) change in one of their genes that may contribute to an increased tendency to~     develop lung cancers, even in never smokers. In some lung cancer patients this gene, called~     EGFR, contains a DNA change known as an inherited EGFR mutation. Early data indicate that~     these inherited EGFR mutations may be associated with an increased risk of lung cancer.~      So far, only a small number of families have been found to carry inherited EGFR mutations.~     For this reason the risk of lung cancer associated with inherited EGFR mutations is not well~     understood. Understanding the risk may help investigators find ways of detecting lung cancer~     sooner or reducing the risk of developing lung cancer.~      It was recently discovered that lung cancer patients who are found to carry one rare EGFR~     mutation in their cancer cells, called T790M, have an increased risk of carrying an~     inherited EGFR mutation in their normal cells as well. This represents a new strategy for~     finding individuals and families carrying inherited EGFR mutations.~      This research study is designed to find cancer patients whose tumors have this EGFR mutation,~     T790M, to find out if they also have an inherited EGFR mutation. Subjects will not have to~     undergo a biopsy to participate in this research study. Investigators will collect a saliva~     specimen from patients with a T790M in their cancer to find out if they also have an~     inherited EGFR mutation.~      Study participants found or known to carry an inherited EGFR mutation will have the option of~     offering their close relative the opportunity to also participate in this study. Close~     relatives can consider testing to see if they also carry the inherited mutation in their~     normal cells. Once investigators have identified individuals and relatives that carry~     inherited EGFR mutations in their genes, investigators will then try to understand the risk~     of lung cancer and other cancers. Individuals with inherited EGFR mutations will also have~     the opportunity to participate in future studies related to cancer and other diseases.~      This study is being funded in part by the Conquer Cancer Foundation of ASCO and the Bonnie J.~     Addario Lung Cancer Foundation.~   "
138540|NCT01753908|"~     This randomized pilot trial studies broccoli sprout extract in treating patients with breast~     cancer. Broccoli sprout extract contains ingredients that may prevent or slow the growth of~     certain cancers. Studying samples of tissue from patients receiving broccoli sprout extract~     may help determine if it can enter breast tumor cells and how it affects certain biomarkers.~   "
138532|NCT01754012|"~     NU-AGE is a large multidisciplinary consortium (31 partners, from 17 EU countries) involving~     nutritionists, bio-gerontologists, immunologists and molecular biologists from the most~     prestigious institutions in Europe, 5 large food industries, 8 traditional food companies and~     1 biotech SME, SPES GEIE and CIAA, covering the SME Food Industrial Associations of 13~     European countries and the European Confederation the food and drink industry. NU-AGE aims~     are: 1. to counteract the physical/cognitive decline occurring in the elderly as a~     consequence of the progressive alteration of different organs/systems (immune and~     cardiovascular systems, bone, brain, muscle and intestine) by one year elderly-tailored whole~     diet intervention on 1250 healthy elderly men and women aged 65-79 years (half diet, half~     control) from 5 different EU regions; 2. to assess the effect of the newly designed food~     pyramid specific for 65+ EU citizens on the different organs/systems using a large set of~     biomarkers related to nutrition and aging, with particular attention to the low grade,~     chronic, systemic inflammatory status named inflammageing, a major risk factor for common~     age-related diseases; 3. to perform in a subgroup of 120 subjects in depth studies and high~     throughput omics to identify cellular/molecular targets/mechanisms responsible for whole~     diet effect; 4. to perform genetic and epigenetic studies to assess the role of individual~     variability on the response to diet; 5. to adopt an integrative comprehensive approach~     (systems biology) to analyze the whole set of data. The results of dietary intervention will~     be used to develop elderly-tailored prototypes of functional foods and to improve traditional~     foods. The research activity will be accompanied and followed by a strong activity of~     dissemination and industrial exploitation to support EU strategies on nutritional~     recommendations, thus contributing to the implementation of legislation related to~     nutritional and health claims for elderly in Europe.~   "
138533|NCT01753999|"~     The goal of the study is to examine the possible underlying causes of sleep apnea (a disorder~     in which there are problems with breathing during sleep) in World Trade Center Responders.~     The study will look at the relationship between sleep apnea and various nose and throat~     conditions. Specifically, the study will look at upper airway disease (problems with the nose~     and throat), nasal inflammation, and nasal resistance (the amount of airflow through the~     nose). Subjects will have a physical exam and answer questions about nasal symptoms and~     sleeping problems. Nasal lavage (washing the inner nasal passages) will be performed on the~     subjects and markers of inflammation will be measured in the lavage fluid. Rhinomanometry~     (measuring the airflow through the nose) will also be performed to measure the degree of~     airflow obstruction. All subjects will be asked to perform in-home sleep apnea monitoring.~     Those subjects who are diagnosed with sleep apnea will test two treatment methods. Sleep~     apnea is treated by using a CPAP (continuous positive airway pressure) device. This device~     blows air into a mask worn by the patient during sleep. The two treatment methods that will~     be tested are the fixed pressure CPAP (pressure is constant during use) and CPAP-flex~     (pressure decreases when the subject exhales). Patients will be randomly assigned to one~     treatment method for one month then crossed to the other treatment method for the next month.~     The investigators will determine if patients with certain nasal conditions (high nasal~     resistance) are more likely to use CPAP-flex rather than CPAP.~   "
138534|NCT01753986|"~     The investigators hypothesize that individuals receiving the brief substance use intervention~     will have better substance use and intimate partner violence outcomes than individuals~     receiving the general health improvement intervention. All participants receive standard~     batterer intervention.~   "
138535|NCT01753973|"~     Metabolic syndrome (MS) is characterized by a series of metabolic and hemodynamic parameters~     such as hypertension (hypertension), abdominal obesity, dyslipidemia, abnormal glucose~     metabolism and insulin resistance, resulting in increased cardiovascular morbidity and~     mortality and the risk for developing type 2 diabetes mellitus (T2DM). Metabolic syndrome is~     a common event after renal transplantation. The prevalence of MS increases post-transplant~     with weight gain. In renal transplant recipients, the SM is associated with CVD, diabetes~     after transplantation, worsening renal function and graft loss. Immunosuppressant medications~     have primary effect on the pathophysiology of MS. Several studies have evaluated the~     prevalence and impact of metabolic syndrome in renal transplant recipients as obesity,~     hypertension, dyslipidemia and use of immunosuppressants. The objectives of this study are to~     determine whether the determination of the metabolic syndrome at 6 months predicts this same~     condition at 12 months, determine the prevalence of metabolic syndrome at 12 months, to~     assess the prevalence of obesity and overweight in this population and to assess the~     prevalence of diabetes mellitus after renal transplantation. Patients who meet the inclusion~     criteria and did not meet the exclusion criteria will be invited to participate in the study,~     signing the Instrument of Consent (IC) and informed about the objectives and procedures of~     the study to be performed, with age between 18 and 60 years, both sexes, renal transplant~     recipients Renal Transplant Unit, Hospital das Clinicas, FMUSP living donor or deceased and~     use of immunosuppressive regimen consisting of tacrolimus, mycophenolate sodium and~     prednisone. Sampling will be conducted laboratory tests, filling out questionnaires on~     quality of life and anthropometric measures.~   "
138536|NCT01753960|"~     The purpose of this study is to determine whether Noninvasive and Continuous Hemoglobin~     Monitoring (NACHO) for Surgical Blood Management affects transfusion decision making~     algorithm in the operating room.~   "
138537|NCT01753947|"~     Training on simulated models in a surgical skills laboratory has been shown to improve~     technical performance in the operating room. Currently described simulation-based curricula~     consist of trainees practicing the same tasks until expert proficiency is reached. It has yet~     to be investigated whether individualized deliberate practice, where curricula tasks vary~     depending on prior levels of technical proficiency, would translate to the operating room.~      This randomized controlled trial effectively demonstrates that deliberate practice on a~     virtual reality simulator results in an improvement in technical skills in a real clinical~     situation. This enhances the feasibility of implementing simulation-based curricula into~     residency training programs, and consequently has the potential to improve patient safety.~   "
138538|NCT01753934|"~     About the Study: This research study is being conducted to see if diabetic ketoacidosis has~     any impact on learning, behavior and development in children with Type 1 diabetes mellitus.~     If there is an impact, is it transient or persistent? Sixty to 80 children between the ages~     of 4 to 17 years with Type 1 diabetes mellitus will have neuropsychological testing and a~     non-sedated MRI scan of the head performed. The investigators will compare this to a control~     group of 30-40 children between the ages of 4 to 17 years without Type 1 diabetes mellitus.~     The children with Type 1 diabetes mellitus will not have any changes made to their current~     diabetes regimen. The children with Type 1 diabetes mellitus should continue to check blood~     glucose values as required by your doctor and bring their meter(s) for downloading to each~     visit. The children with Type 1 diabetes mellitus should also tell your doctor about the~     frequency of severe low and high blood glucose values.~   "
138542|NCT01753882|"~     The primary goal of the proposed clinical trial is to investigate the combined effects of~     walking training and monoaminergic agents (SSRIs and TIZ) on motor function of individuals in~     sub-acute (2-7 mo) human motor incomplete Spinal Cord Injury (SCI), with a primary emphasis~     on improvement in locomotor capability. We hypothesize that the use of these drugs applied~     early following SCI may facilitate independent stepping ability, and its combination with~     intensive stepping training will result in improved locomotor recovery following incomplete~     SCI. Loss of descending control via norepinephrine inputs following spinal cord injury can~     impair normal sensorimotor function through depressing motor excitability and impairing~     walking capacity. Replacing these inputs with drugs can alter the excitability and assist~     with reorganization of locomotor circuits. Assessment of single-dose administration of these~     agents has been tested in patients with motor incomplete spinal cord injury; only limited~     changes in walking performance have been noted. The resultant onset of weakness and increase~     in involuntary reflexes following motor incomplete SCI may partly be a result of damage to~     descending pathways to the spinal cord that control the release of serotonin. In models of~     SCI, for example, application of agents that simulate serotonin has been shown to change~     voluntary motor behaviors, including improvement of walking recovery. In humans following~     neurological injury, the effects of 5HT agents are unclear. Few previous reports indicate~     improved motor function following administration of agents which enhance the available~     serotonin in the brain, although some data suggests that increased serotonin may be~     beneficial. In this application, we propose to study the effects of clinically used agents~     that increase or decrease intrinsic serotonin activity in the brain on strength and walking~     ability following human motor incomplete SCI. Using detailed electrophysiological recordings,~     and biomechanical and behavioral measures, we will determine the effects of single or chronic~     doses of these drugs on voluntary and involuntary motor behaviors during clinical measures~     and walking measures. The novelty of this proposed research is the expectation that agents~     that increase serotonin activity may increase abnormal reflexes in SCI, but simultaneously~     help to facilitate motor and walking recovery. Despite potential improvements in voluntary~     function, the use of pharmacological agents that may enhance spastic motor behaviors~     following SCI is in marked contrast to the way in which drugs are typically used in the~     clinical setting.~   "
138543|NCT01753869|"~     Lung disease is the predominant cause of morbidity and mortality in Cystic Fibrosis (CF) with~     80% of deaths resulting directly or indirectly from pulmonary disease. Abnormal airway~     clearance causes retention of mucus resulting in frequent chest infections. Physiotherapists~     use different techniques to help clear mucus from the lungs of patients with CF. Inhaled~     medications and airways clearance techniques (ACTs) are central to a CF patient's daily~     treatment and are often coordinated.~      Burden of treatment is a common reason for non-adherence in this patient group, and~     streamlining of treatment timings is sought to optimize adherence whilst ensuring efficacy to~     an often complex daily regimen of inhaled bronchodilators, nebulizers and ACTs. A gap in the~     research exists as to the optimal timing of Hypertonic Saline (HTS) and ACT within the daily~     regimen. A study to show whether the timing of HTS around ACT is significant, can better~     inform patients and potentially allow more flexibility around their treatment regimen.~      Lung Clearance Index (LCI) has shown good sensitivity to abnormalities in lung function~     compared with spirometry and has demonstrated a treatment effect in other trials. LCI may be~     a suitable tool therefore, to assess intervention strategies aimed at airways clearance in~     CF. This study aims to compare the effects ACTs after HTS inhalation versus ACTs during HTS~     inhalation as measured by LCI.~      It is a randomized, crossover trial of ACTs after HTS inhalation compared with ACTs during~     HTS inhalation in adult CF patients during day 10-14 of a hospital admission for treatment of~     a pulmonary exacerbation. Patients will be randomized to receive 1 of the treatment session~     options on the first day and the reverse on the second day.~      The primary objective of this study is to compare the change in LCI (a measure of lung~     function) at 90 minutes post treatment with ACTs after HTS inhalation compared with ACTs~     during HTS inhalation in adult CF patients.~      LCI (lung clearance index) ACT (airway clearance technique) HTS (hypertonic saline)~   "
138544|NCT01753856|"~     The purpose of this study is to determine how teriparatide or denosumab affects the bone of~     postmenopausal women with osteoporosis after 3 months of treatment, as determined by a bone~     biopsy sample taken from the iliac crest (upper part of the pelvis).~   "
138545|NCT01753843|"~     RESEARCH HYPOTHESIS Brief delay(>30 sec to <60 sec ) in cord clamping as compared to early~     cord clamping (< 20 sec) leads to a better short term neurobehavioural outcome in preterm~     (34-36 wks) neonates when assessed by neurobehavioral assessment of preterm infants~     (n.a.p.i.) at 37 weeks of post conceptional age~   "
138546|NCT01753830|"~     The purpose of the study is to determine whether a single intra-articular injection of~     Durolane is superior to a single injection of PBS for the relief of joint pain in patients~     with osteoarthritis of the knee.~   "
138547|NCT01753817|"~     Radial artery occlusion may occur after performance of coronary catheterization via the~     radial artery (transradial approach). In some cases it may be desirable to insert large (7F)~     catheters via the radial artery, however the impact of increased catheter size on subsequent~     radial artery patency is unclear. We hypothesize that radial artery occlusion following 7F~     catheterization is rare and occurs in < 5% of the cases.~   "
138548|NCT01753804|"~     To characterize the natural history and progression of Duchenne Muscular Dystrophy (DMD) to~     help inform the design of future studies, to capture biomarkers of safety and disease~     progression and to provide comparative data for the development of rare exons for which~     formal controlled trials are not feasible.~   "
138549|NCT01753791|"~     The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of~     PF-06473871 in normal healthy adults.~   "
138550|NCT01753778|"~     A proof of concept study to evaluate the feasibility of safe and effective treatment through~     optimization of the Cryo-Touch III Device for temporary relief of pain.~   "
138551|NCT01753765|"~     A proof of concept study to evaluate the feasibility of safe and effective treatment through~     optimization of the Cryo-Touch III device for temporary relief of or reduction in pain due to~     occipital neuralgia.~   "
138552|NCT01753752|"~     In the elderly population, dry eye syndrome is a highly prevalent ocular disease. One~     mainstay of therapy for patients suffering from dry eye syndrome is the use of topically~     administered lubricants. One of the main disadvantages of the formulations currently~     available for the treatment of DES is the short residency time on the ocular surface, which~     increases the need for a frequent instillation of the lubricant.~      Recently, Croma Pharma has introduced chitosan-N-acetylcysteine eye drops, designed for~     treatment of symptoms related to DES. Based on theoretical considerations and animal~     experiments, the new chitosan derivative may show an increased adhesion to mucins of the~     ocular surface and may therefore considerably increase the residence on the ocular surface.~     This, in turn, would limit the need for frequent treatment and decrease the burden for the~     patients.~      It has been shown in recent Phase I studies that chitosan-N-acetylcysteine eye drops are safe~     and well tolerated after single and repeated instillation. The current study seeks to~     investigate the ocular residency time after a single dose and after 5 day b.i.d. treatment.~     For this purpose 2 cohorts are planned: In Cohort I, chitosan-N-acetylcysteine eye drops will~     be instilled once in one randomly chosen eye, whereas the fellow eye will receive placebo.~     Measurements of tear film thickness will be performed with optical coherence tomography (OCT)~     before instillation and 10 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 10 hours, 12 hours and~     24 hours after instillation. In addition, ocular scattering of the tear film will be assessed~     with an Optical Quality Analysis System (OQAS) at the same timepoints. Determination of break~     up time (BUT) will be performed before and after instillation of the eye drops.~      In Cohort II, chitosan-N-acetylcysteine eye drops will be instilled once daily in one eye and~     b.i.d. in the fellow eye on five consecutive days. Measurements of tear film thickness with~     OCT and OQAS will be performed every study day before the morning instillation and the day~     after the last instillation. Additionally, patients will be asked to answer the ocular~     surface disease index (OSDI©) on day 1 and day 6. BUT will be determined before and after~     instillation of the eye drops.~   "
138553|NCT01753739|"~     This study will examine dose ranging characteristics of bepotastine besilate nasal spray~     compared to placebo nasal spray in 600 male or female subjects 12 years of age and older with~     active seasonal allergic rhinitis (SAR) and a demonstrated history of allergic sensitivity to~     Mountain Cedar pollen for at least 2 years prior to the study.~   "
138554|NCT01753726|"~     Physical therapists have traditionally included various forms of manual therapy among the~     therapeutic approaches to spinal pathologies. The aim of this study was to evaluate the~     effect of diaphragmatic stretching on spine and thoracic movement in healthy adults.~   "
138557|NCT01753687|"~     Dry eye syndrome (DES) is a highly prevalent ocular condition inducing an inflammatory~     response of the ocular surface. Common symptoms include ocular discomfort, visual impairment~     and instability of the tear film with potential damage to the ocular surface.~      The rationale of the present study is to compare signs as assessed with new methods such as~     measurement of tear film thickness, tear film osmolarity and scattering of the tear film with~     well established methods for assessment of the severity of DES (Break up time, staining of~     the cornea with fluorescein). Additionally, impression cytology and determination of tear~     cytokines/chemokines will be performed to obtain information about inflammatory processes on~     the ocular surface.~   "
138558|NCT01753674|"~     Our hypothesis is that TA-65, a dietary supplement will help to reduce insulin resistance and~     plasma glucose in individuals classified with metabolic syndrome.~   "
138559|NCT01753661|"~     The purpose of the proposed exploratory research protocol is to investigate the feasibility~     and efficacy of Project ASPIRE, a parent-directed intervention aiming to increase parental~     skills and enrich children's early language environments and ultimately improve child~     outcomes in children with hearing loss from low-income backgrounds.~   "
138560|NCT01753648|"~     Recently, a new and sophisticated method for assessment of retinal blood flow and retinal~     blood flow velocity profiles has become available. This technique is based on the combination~     of measurement of retinal vessel calibers with bidirectional Fourier domain optical coherence~     tomography (FDOCT). The valid measurement of retinal blood flow is of significant importance,~     because it is known that major ophthalmic diseases, such as hypertensive retinopathy, are~     associated with alterations in blood flow.~      Hypertensive retinopathy is the most common manifestation of arterial hypertension in the~     eye. Elevated systemic blood pressure leads to generalized arteriolar narrowing caused by~     vasospasms and increased vascular tone. Further in the disease process, focal arteriolar~     narrowing, retinal haemorrhages, hard exudates and cotton wool spots can occur. Previous~     studies have shown that blood flow in the extraocular vessels and in the choroid is~     compromised in patients with arterial hypertension. However, data on the impact of arterial~     hypertension on retinal blood flow and retinal blood flow velocities are lacking.~      The present study sets out to compare total retinal blood flow and retinal velocity profiles~     in patients with hypertensive retinopathy and healthy age- and sex-matched controls. Ocular~     perfusion pressure will be calculated based on measurements of blood pressure and intraocular~     pressure to allow for calculation of vascular resistance. In addition, velocity profiles at~     arterio-venous crossings will be measured. It is hypothesized that these velocity profiles~     are considerably modified in patients with stage 2 and 3 hypertensive retinopathy compared to~     healthy controls because of pronounced arterio-venous compression.~   "
138561|NCT01753635|"~     The purpose of this study is to compare the performance of the Baska mask supraglottic airway~     device with a single use laryngeal mask device (LMA) in low-risk female patients.~      The investigators have performed a number of studies on novel airway devices, including 3~     studies on the Baska mask. This trial will compare some performance characteristics of the~     studied devices, including airway seal pressures, insertion success rates, device use~     difficulty scores. Additional performance and device safety data will be accumulated.~      The investigators have two primary hypotheses, namely 1.Non-inferiority of first placement~     attempt success rate of the Baska mask vs LMA; and 2.greater seal pressure of the Baska mask~     vs LMA.~   "
138562|NCT01753622|"~     Obesity and overweight have become an epidemic in the world and its prevalence between~     pregnant women is especially dangerous. Having a high Body Mass Index (BMI) is also~     associated with depression disorders and its serious complications during this period.~   "
138563|NCT01753609|"~     The study will assess the safety and performance of an intragastric auto-inflating and~     degradable balloon~   "
138564|NCT01753596|"~     Dry eye syndrome (DES) is a highly prevalent ocular condition with severe consequences for~     the patients reaching from ocular discomfort in its simplest form up to visual impairment and~     corneal ulceration in severe cases. Data from epidemiological studies indicate that DES is a~     common disease, especially in the elderly population, affecting up to 20% of adults aged 45~     years or older. Topical lubricants are a mainstay of therapy, but data on its effect on tear~     film thickness and the corneal residence time are lacking.~      Recently, a new objective method for assessment of tear film thickness by optical coherence~     tomography has been developed. The present study aims to investigate the corneal residence~     time of an established topical lubricant compared to placebo in patients with DES and healthy~     controls.~   "
138565|NCT01753583|"~     Corneal lesions such as corneal abrasions and corneal infiltrates are common in clinical~     practice. The current study seeks to investigate whether high-resolution OCT is suitable for~     imaging of these corneal lesions. The present study has the character of a pilot study and~     the results are intended to be used to develop a standardized protocol for imaging and~     analysis of these corneal lesions. Based on this protocol, further studies investigating the~     pathophysiology of corneal lesions or evaluating therapeutic success can be planned.~   "
138566|NCT01753570|"~     This study will evaluate the efficacy and safety of MP-424 with IFN beta and RBV in patients~     with genotype 1/2 hepatitis C, who are treatment-naïve or have received its treatment before.~   "
138567|NCT01753557|"~     This study will evaluate the efficacy and safety of MP-424 with PEG-IFN Alfa-2a and RBV in~     patients with genotype 1 hepatitis C, who are naïve to its treatment or relapsed after~     previous treatment.~   "
138568|NCT01753544|"~     We aim to evaluate safety and feasibility of a thulium laser system in performing endoscopic~     submucosal dissection of gastric neoplasia.~   "
138569|NCT01753531|"~     The clinical performance of the Ultra Influenza A&B Test will be demonstrated during a~     clinical trial in which prospectively collected nasal swabs are used in identifying subjects~     who are infected with the influenza virus strain type A or type B. The Ultra Influenza A&B~     Test qualitative results will be compared to Gold Standard viral culture with Direct~     Fluorescent Antibody (DFA) confirmation techniques using nasal swabs collected from~     symptomatic subjects. The Ultra Influenza A&B Test will be performed at Clinical Laboratory~     Improvement Amendments (CLIA) waived sites by untrained intended users (e.g. nurses,~     physician assistants, medical assistants, etc.). For viral culture testing with DFA~     confirmation testing, nasal swab specimen testing will be performed by a designated reference~     laboratory.~   "
138570|NCT01753518|"~     Currently, the way doctors close the skin during cesarean section is different between~     surgeons and there is little evidence to support the use of one kind of closure over the~     other. At the Mayo Clinic Family Birth Center, skin is currently closed using an absorbable~     suture (or stitch), placed within the top layer of skin. At other institutions, a metal~     staple is often used to close the skin.~      There is a new technique that uses special absorbable staples just beneath the skin. This~     technology may be equal to, or possibly better than, current skin closure techniques.~     However, there is currently little data to show how it compares. The purpose of this study is~     to compare the absorbable staple to the currently used absorbable suture. The data from this~     study will then be used to help determine the best technique for skin closure.~   "
138571|NCT01753505|"~     The aim of this study is to evaluate the clinical usefulness of 64-slice multidetector~     coronary CT angiography (MDCTA) in renal transplant recipients who had no previous coronary~     artery disease (CAD). Primary endpoint is to assess the prevalence and severity of coronary~     artery disease in patients post-transplant 6 to 12 months. CAD can be diagnosed noninvasively~     with similar accuracy of coronary angiography using MDCTA. Early detection and intervention~     of CAD may provide survival benefit in renal transplant recipients.~   "
138572|NCT01753492|"~     Trabeculectomy is the gold standard procedure for the surgical treatment of glaucoma.~     Antimetabolites such as mitomycin-C (MMC)are widely used as an adjunctive during surgery to~     prevent scarring of the bleb. MMC has the risk for creating thin bleb walls, avascular blebs,~     and increased risk to infection, blebitis and endophthalmitis.~      Recently, a biodegradable porous collagen-glycosaminoglycan copolymer matrix implant~     (Ologen), has become available for glaucoma surgery.Although a few studies on filtering~     surgery with Ologen implantation have been performed, there is yet no conclusive evidence on~     effectivity and safety with Ologen implantation when compared to trabeculectomy with MMC.~      This is a prospective intervention pilot study to determine the degree of intraocular~     pressure (IOP) lowering of trabeculectomy with Ologen implantation in comparison to~     trabeculectomy with MMC. Additionally, the safety (per- and postoperative complications) of~     the two procedures will be compared.~      The study hypothesis is that trabeculectomy with Ologen will be a safer procedure than~     trabeculectomy with MMC, but probably at the cost of a less potent IOP lowering.~   "
138573|NCT01753479|"~     Purpose of this study is to understand the clinical feasibility of duodenal spectroscopy to~     adenocarcinoma patients.~   "
138574|NCT01753466|"~     The investigators are conducting a six-week randomized controlled pilot trial to assess the~     feasibility and safety of increased water intake in patients with chronic kidney disease.The~     investigators will study 30 patients (age 30 to 80 with an estimated glomerular filtration~     rate between 30 and 60 ml/min/1.73m2 and microalbuminuria [albumin to creatinine ratio >2.8~     mg/mmol (if female) or >2.0 mg/mmol if male)].The investigators will randomize patients (in a~     2:1 ratio) to a fluid-intervention group or control group. Participants who are randomized to~     the hydration-intervention group will be asked to consume 1.0 to 1.5 L water per day~     (depending on sex and weight) in addition to usual consumed beverages, for 6 weeks.~     Participants in the control group will be advised to consume their usual amount of fluid.~      The investigators hypothesize that patients will be able to increase and maintain a higher~     fluid intake with stable blood chemistry, particularly serum sodium.~   "
138575|NCT01753453|"~     The primary objective of this study is to evaluate tumor cell mobilization (TCM) with~     non-pegylated G-CSF alone compared with non-pegylated G-CSF plus plerixafor in patients with~     multiple myeloma (MM) who are potentially poor mobilizers of hematopoietic stem cells (HSC).~      Second objectives are to evaluate survival and disease status of G-CSF alone compared with~     GCSF plus plerixafor, and the efficacy and safety of G-CSF plus plerixafor when used to~     mobilize stem cells for autologous transplantation.~   "
138576|NCT01753440|"~     The aim of the present study is to investigate safety and efficacy of intramyocardial~     implantation of allogeneic mesenchymal stem cells in patients with ischemic cardiomyopathy at~     the time of coronary artery bypass grafting.~   "
138577|NCT01753427|"~     The objective of the study is to assess patient's perception with stable state COPD on~     symptom variability and to describe how symptom variability impacts daily quality of life in~     Chinese COPD patient with moderate, severe or very severe airflow limitation from tier 3~     hospitals in China where most of COPD patients are diagnosed and treated.~   "
138578|NCT01753414|"~     Rationale: Surgery remains the standard of care for stage 1 (T1-2a N0)non-small cell lung~     cancer. Stereotactic body radiation therapy is a newer radiation treatment that gives fewer~     but higher and possibly more effective doses of radiation than standard radiation. This~     technique may be able to send x-rays directly to the tumor and cause less damage to normal~     tissue. It is not yet known whether stereotactic body radiation therapy is more effective~     than surgery in treating non-small cell lung cancer.~      Purpose: The primary aim of this randomized phase II trial is to determine if the efficacy of~     SBRT is comparable to that of standard surgical interventions for patients with T1N0~     non-small cell lung cancer.~   "
138579|NCT01753401|"~     This Phase 4 study is being performed to examine the effects of Acthar for the indicated use~     of treatment of SLE. This study will enroll patients with steroid-dependent, persistently~     active SLE with arthritic and/or cutaneous involvement. The study will involve two phases: a~     double-blind phase, to provide placebo-controlled safety, efficacy, and pharmacodynamic data,~     and an optional open-label phase, to examine the prolonged effects of Acthar maintenance.~   "
138580|NCT01753388|"~     The purpose of this study is to assess the safety and performance of the Penumbra Liberty~     Stent System as adjunctive treatment to embolic coils for wide-neck, saccular, intracranial~     aneurysms.~   "
138593|NCT01753219|"~     The objective of this study is to evaluate chronic pain and sexual dysfunction after inguinal~     hernia repair involving mesh fixation with sutures (Lichtenstein) compared with no mesh~     fixation (Onstep). The study hypothesis is that a smaller proportions of patients operated~     without mesh fixation (Onstep) will have chronic pain that impairs daily function.~   "
138619|NCT01752881|"~     The purpose of this study is to evaluate the antibody response to each of the three influenza~     vaccine strains included in the licensed seasonal flu vaccine, as measured by~     hemagglutination inhibition (HAI) at three weeks post immunization in non-elderly and elderly~     subjects in compliance with the requirements of the current European Union (EU)~     recommendations for the evaluation of the immunogenicity for a new formulation of a licensed~     flu vaccine (CPMP/BWP/214/96).~   "
138581|NCT01753375|"~     Vitamin D3 supplementation reduces the incidence of multiple sclerosis.Although clinical~     cross-sectional studies have demonstrated vitamin D3 as a positive mediator in preventing~     relapses and disease progression, prospective randomized control trials are nevertheless~     necessary to confirm these statements and to determine the most efficacious, safe, and the~     minimum required doses. This hypothesis is going to be tested through a randomized triple~     blinded controlled trial in which after randomization, one group of patients will receive~     vitamin D and second group will receive placebo. Both groups are going to be followed in a~     similar way over a period of one year with follow ups at 4, 8 and 12 months. Vitamin D levels~     is going to be performed at 0,4, 12 month interval. MRI is going to be done at the beginning~     and end of trial.The number of relapses and the physical disability will be calculated~     through the Expanded disability status scale (EDSS).~   "
138582|NCT01753362|"~     The purpose of this study is to examine the effects of liraglutide (a drug used to treat type~     2 diabetes) on glucose (sugar) control over the 26 week study period when used in addition to~     insulin.~   "
138583|NCT01753349|"~     The purpose of the study is to document long-term response in real-life practice after~     injection cycles with BoNT-A in subjects suffering from idiopathic cervical dystonia~     (Long-term clinical and pharmaco-economic data).~   "
138584|NCT01753336|"~     The purpose of the protocol is to assess the long term safety of repeat treatment cycles of~     Dysport® 500 U using 2 mL dilution scheme for the treatment of Cervical Dystonia. This is an~     extension study to study A-TL-52120-169 (hereafter referred to as Study 169).~   "
138585|NCT01753323|"~     This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria~     patients with P. vivax or P. falciparum infection after 3 day dosing with KAF156 at 400~     mg/day (Part 1) and single dosing with KAF156 at 800mg (Part 2)~   "
138586|NCT01753310|"~     The purpose of the protocol is to evaluate the efficacy and safety of Dysport® using 2 mL~     dilution compared with placebo for the treatment of Cervical Dystonia.~   "
138587|NCT01753297|"~     The purpose of this study is to assess the benefit of immediate hormonal treatment after~     Radical Prostatectomy in Chinese and Russian patients with high risk prostate cancer. To~     reach this target, the trial will compare a group of patients treated with triptorelin at 8~     weeks after the surgery and for a duration of 9 months (3 injections) versus another group~     (called active surveillance group) who will be not receiving triptorelin. Both groups will~     be followed every 3 months to monitor any sign of disease progression during a minimum of 36~     months~   "
138588|NCT01753284|"~     First episode psychosis patients often experiences treatment delay. This reduces their~     prospects for recovery and makes unnecessary burdens for them and their carers. A better~     understanding of help seeking intentions is required, and has not been explored in a county~     like Nordland, Norway, with long distances and challenging access to health services. The~     purpose of this study is to explore the process of help seeking, including how patients and~     their careers discover and understand the psychotic symptoms. Research exploring the impact~     on families mainly focuses on parents` experiences, and there are less studies focusing on~     experiences and needs of siblings. This study will therefore explore siblings` experiences~     separate from their parents. Methods will be qualitative interviews with patients, their~     carers and siblings. Analysis will be influenced by Grounded theory.~   "
138589|NCT01753271|"~     Specific Aims and Hypotheses Aims To investigate the incremental benefits of cervicothoracic~     spinal manipulation in addition to shoulder mobilization and exercise for improving range of~     motion, pain, physical function and fear avoidance beliefs in patients with subacromial~     shoulder impingement.~      Hypotheses It is hypothesized that those subjects who receive spinal manipulation in addition~     to shoulder mobilization and exercise will achieve greater improvements in range of motion,~     pain, function and fear avoidance beliefs at two weeks following treatment conclusion, at 4~     weeks following treatment conclusion, and at discharge when compared to the subjects who did~     not receive the spinal manipulation.~   "
138590|NCT01753258|"~     The focus of this pilot study is to determine if a woman who experiences pain during sexual~     intercourse has a higher risk of complications during labor and delivery secondary to pelvic~     floor dysfunction, anxiety and intolerance towards pelvic examinations. Furthermore, it is~     unclear whether women with prepartum dyspareunia experience an improvement following vaginal~     delivery. While physicians may expect that vaginal birth improves dyspareunia due to the~     stretching effect on pelvic floor, to date, there is insufficient evidence to support this~     claim. The Investigators plan to prospectively study 200 patients at our Institution, collect~     information regarding birth and follow them, via questionnaires, regarding their dyspareunia~     postpartum.~   "
138591|NCT01753245|"~     It has been reported in various epidemiological studies that patients with moderate-to-severe~     plaque psoriasis, with or without associated psoriatic arthritis, have an increased frequency~     of cardiovascular risk factors, such as hypertension, obesity, type-2 diabetes mellitus~     (T2DM, and metabolic syndrome (MetS). The presence of endothelial dysfunction in early~     stages, especially in moderate-to-severe plaque psoriasis forms, could explain the higher~     prevalence of cardiovascular disease and mortality observed in this population. Existing~     evidence showing improvement in psoriasis after correcting some factors, such as obesity or~     hypercholesterolemia, and the reduction of certain surrogate markers of cardiovascular risk~     with different modalities of psoriasis treatment suggest a biological interaction between the~     two diseases beyond mere epidemiological association. Recently published results support this~     hypothesis and suggest that the link between psoriasis and cardiovascular disease could be~     the existence of an inflammatory state in different organs, including skin, joints, adipose~     and hepatic tissue, and vascular endothelium (16). Patients with MetS have an increased risk~     of developing T2DM and cardiovascular disease. This syndrome is characterized by the~     association of an adipose tissue inflammatory state and diminished sensitivity to insulin. In~     recent years, a new mechanism participating in the development of MetS has been added: the~     Wnt signaling pathway. Polymorphisms in genes of the Wnt signaling pathway have been~     associated with metabolic abnormalities that predispose to cardiovascular disease, the~     development of moderate-to-severe plaque psoriasis, with or without associated psoriatic~     arthritis, and response to treatment with anti-TNF-alpha.~      This study aims to describe the cardiovascular risk factors of a Spanish population of~     patients with moderate-to-severe plaque psoriasis, with or without associated psoriatic~     arthritis,treated with anti-TNF under routine clinical practice conditions. Possible~     differences in efficacy relative to the presence or absence of criteria of metabolic syndrome~     will be analyzed. Similarly, we will explore the role of markers of inflammatory activity and~     genetic polymorphisms in the Wnt pathway in predicting response to treatment during the first~     year.~   "
138592|NCT01753232|"~     Low Density Lipoprotein (LDL)-apheresis refers to a procedure in which blood taken from a~     patient's vein is cleaned from pathogenic substances, e.g. cholesterol, outside the body and~     then given back to the patient. In the DALI (Direct Adsorption of Lipoproteins)-system whole~     blood is pumped over an adsorber containing beads that selectively bind LDL-cholesterol. The~     MONET (Membrane filtration Optimized Novel Extracorporeal Treatment)-system works with plasma~     which is cleaned by filtration. This study comprises the recording of safety and efficacy~     data from patients treated either with the DALI or MONET-system over a period of 2 years.~   "
138594|NCT01753206|"~     Study Objectives The study is to identify prevalence, demography and clinical characteristics~     of patients with resistant hypertension among hypertensive patients who have been treated in~     general hospitals in Korea from Jan 2012 to Jun 2012.~        -  Diagnosis of resistant hypertension: In case of clinic blood pressure exceeding the~          boundary of systolic blood pressure at 140mmHg and diastolic blood pressure at 90mmHg~          (hereinafter refer to as 140/90mmHg) (130/80mmHg for patients with diabetes mellitus or~          chronic renal disease) despite triple antihypertensive therapy at optimal dose may be~          diagnosed as resistant hypertension. Antihypertensive medications used include~          diuretics. Resistant hypertension may also be diagnosed when clinic blood pressure has~          reached the target value but quadruple or more of antihypertensives are used.~        -  Diagnosis of controlled hypertension: Patients whose clinic blood pressure equals to~          140/90mmHg (130/80mmHg for patients with diabetes mellitus or chronic renal disease) or~          less with the administration of antihypertensives at optimal dose may be diagnosed as~          controlled hypertension.~   "
138595|NCT01753193|"~     The purpose of this study is to evaluate the long-term safety of MEDI-546 in adults with~     moderate to severe active systemic lupus erythematosus~   "
138596|NCT01753180|"~     A prospective, multi-center, double blind, 2 stage, placebo-controlled, phase II study,~     evaluating acute intra-coronary injected collagenase prior to routine standard-of-care~     percutaneous revascularization procedures in subjects with chronic total coronary artery~     occlusions (CTOs).~   "
138597|NCT01753167|"~     This is a Phase II, randomized, double-blind, placebo-controlled study designed to assess the~     safety and clinical activity of multiple intravenous doses of MCMV5322A/MCMV3068A in~     cytomegalovirus (CMV)-seronegative recipients of a renal transplant from a CMV-seropositive~     donor, with use of a preemptive approach for prevention of CMV disease. Participants will be~     randomized into two treatment groups: active or placebo control; both arms will be followed~     preemptively. The study has a planned enrollment of approximately 120 participants (60 active~     and 60 placebo).~   "
138598|NCT01753154|"~     To investigate the biocompatibility of the peritoneal dialysis (PD) solution balance in~     comparison to the conventional PD solution in APD(automated peritoneal dialysis) patients~     using the APD cycler sleep•safe.~   "
138599|NCT01753141|"~     The Smoking Treatment and Anxiety Management Program (STAMP) is a treatment program focused~     on helping people manage their anxiety while quitting smoking. The study involves coming in~     to our clinic for 4 treatment sessions, with follow-ups for up to 2 years (a week 1, week 2,~     month 1, month 3, month 6, year 1, and year 2 follow-up). Participants will be paid $142.50~     for their full participation as well as receive 6 weeks of free nicotine replacement patches.~   "
138600|NCT01753128|"~     Esophageal hypersensitivity/Functional heartburn are common among non-erosive reflux disease~     (NERD) patients who do not response to proton pump inhibitors. Whether tricyclic~     antidepressant improves NERD patient's symptoms remains unknown~      Aim of this randomized controlled trial study is to determine the efficacy of imipramine,~     which could increase esophageal pain thresholds in healthy volunteers, in comparison with~     placebo for treatment patients with esophageal hypersensitivity or functional heartburn~     evaluated by improvement of specific-symptom score and quality of life~   "
138601|NCT01753115|"~     The purpose of this clinical trial is to determine whether there is any effect on the~     antibiotic, ciprofloxacin when taken before and after administration of a 3-dose series of~     BioThrax® (Anthrax Vaccine Adsorbed or AVA).~      This study will be conducted in the United States (US) in 154 healthy male and female~     volunteer subjects ages 18 to 45.~      The duration of study participation for each subject will be approximately 76 days~     (approximately 2.5 months)~   "
138602|NCT01753102|"~     Estradiol vaginal tablet is a tablet which hydrates upon contact with moisture, releasing~     17ß-estradiol.~      The estradiol in estradiol vaginal tablet is chemically and biologically identical to the~     endogenous human estradiol and is therefore classified as a human estrogen.~      The purpose of this study is to demonstrate clinical endpoint bioequivalence of SPIL's~     Estradiol vaginal tablet, 10mcg estradiol to the reference listed drug (Vagifem®)which is~     approved and marketed in the US.~   "
138603|NCT01753089|"~     This research study is a Phase I clinical trial. Phase I clinical trials test the safety of~     investigational melanoma vaccines. Phase I studies also try to define the appropriate dose of~     the investigational vaccine, in this case WDVAX, to use for further studies.~     Investigational means that the vaccine is still being studied and that research doctors are~     trying to find out more about it. It also means that the FDA has not yet approved WDVAX for~     any use in patients, including people with Melanoma.~      The purpose of this study is to determine if it is possible to make a vaccine against~     melanoma by using your own melanoma tumor cells and combining them with other proteins which~     activate the immune system. We hope that by combining the cells and the proteins in this way~     that the vaccine will cause your own immune system to react against your melanoma tumor~     cells. The purpose of this study is also to determine the safest way to give this vaccine~     with the least amount of side effects.~      Each vaccine will contain your own tumor cells which have been killed by a freezing and~     thawing process which destroys the cells but keeps the proteins from the melanoma cells. This~     is called a tumor lysate Your tumor lysate is combined with other proteins which activate~     the immune system. The other proteins are called GM-CSF and CpG. All of this is held together~     to form a tablet or scaffold which is about the size of a regular aspirin tablet. The~     material that holds the protein together is called PLGA. PLGA is the same material that~     doctors use for dissolvable stitches If you have ever had a problem with these types of~     stitches in the past, be sure to let your study doctor know about this.~   "
138617|NCT01752907|"~     The purpose of this study is to determine if patient education can affect patient reported~     bone pain in breast cancer patients receiving chemotherapy and pegfilgrastim.~   "
138618|NCT01752894|"~     The purpose of the study is 1> to compare neointimal stent coverage after OCT-guided vs.~     Angio-guided PCI, 2> to compare neointimal stent coverage at 3 months after EES vs BES~     implantation, 3> to determine the duration of dual antiplatelet therapy by OCT measurement at~     3 months~   "
138629|NCT01752751|"~     A comprehensive geriatric assessment tool developed by Hurria and colleagues has been used in~     non-radiation oncology clinical settings to predict how older adults tolerate cancer~     treatments. The investigators think this same tool (referred to as the CGA) can be used in a~     radiation oncology clinic to predict for poor treatment tolerance.~   "
138604|NCT01753076|"~     This is a 48-week, randomised, multi-centre, double-blind, placebo-controlled, parallel group~     investigation of the efficacy and safety of intravenous (IV) ozanezumab (GSK1223249) compared~     to placebo in subjects with Amyotrophic Lateral Sclerosis (ALS). Following a screening period~     of up to four weeks, eligible subjects will be randomised (1:1) to receive IV placebo or 15~     milligram (mg)/ kilogram (kg) IV ozanezumab every 2 weeks for a period of 48 weeks with a~     follow-up visit around 14 weeks after the last infusion. A total of approximately 294~     eligible subjects will be randomised from approximately 37 centers worldwide. The primary~     objective is to assess the effect of ozanezumab on the physical function and survival of ALS~     subjects over a treatment period of 48 weeks. Function will be measured using the ALS~     Functional Rating Scale - Revised (ALSFRS-R). Secondary objectives include the evaluation of~     other clinical outcomes associated with ALS (respiratory function, muscle strength,~     progression free survival and overall survival) in support of the primary objective. Quality~     of life, safety, tolerability, immunogenicity and pharmacokinetics (ozanezumab and riluzole)~     will also be assessed.~   "
138605|NCT01753063|"~     As part of Children's Hospital Association's Focus on a Fitter Future III Obesity Task Force,~     this project will target patient and family expectations across the domains of nutrition,~     physical activity and behavior change/family support as a means of patient engagement and~     retention in pediatric weight management. This will be a prospective, non-randomized,~     uncontrolled, single-arm trial for children between 2 and 18 years of age and a~     parent/guardian, who are starting a pediatric weight management program/clinic in one of the~     participating centers. The parent/guardian and child if 12 years of age or older receive a~     survey at the first visit, which asks about their expectations and goals for the visit. This~     information will then be used as part of clinical care to tailor treatment. After 3 months,~     the parent/guardian and adolescent, if applicable, will receive a follow up survey asking~     about their progress in these areas.~   "
138606|NCT01753050|"~     Several studies have demonstrated that goal-directed fluid therapy during high- risk-surgery~     reduces morbidity and length of hospital stay. This quality improvement is design to evaluate~     the implementation of an intraoperative goal-directed therapy, using a pulse contour analysis~     monitor to optimize the stroke volume, in patients undergoing redo-hip-surgery. The primary~     combined endpoints will be the incidence of postoperative complications and the secondary~     endpoints will be the decrease of hospital length of stay, length of ICU stay and hospital~     postoperative mortality. We amended another 130 patients getting crystalloid fluids in the~     hemodynamic optimization protocol.~   "
138607|NCT01753037|"~     The hypothesis of this study is that DHEA administration to increase male hormone in healthy~     normal-weight young women to levels present in women with Polycystic Ovary Syndrome will~     cause an inflammatory response in white blood cells in the fasting state, and in response to~     glucose ingestion.~   "
138608|NCT01753024|"~     Malnutrition is a frequent problem in critically ill patients that is associated with~     detrimental clinical outcomes. To provide adequate nutritional support, current studies~     focused mostly on the choice of delivery timing, formula selection and the route of~     administration, little attention was paid to malnutrition related to exocrine pancreatic~     insufficiency (EPI).~      In fact, malnutrition is also a major consequence of pancreatic exocrine insufficiency and~     pancreatic damage is commonly observed in critically ill patients without prior pancreatic~     diseases. Hence, EPI associated malnutrition should be concerned due to the high prevalence~     of pancreatic damage in critically ill patients.~      The aims of this study is to evaluate the incidence of EPI in critically ill adult patients~     and explore its potential risk factors. Moreover, the efficacy of pancreatic enzyme~     supplementation therapy on malnutrition in ICU patients with specific clinical~     characteristics will be investigated.~   "
138609|NCT01753011|"~     This is a prospective, observational, multicenter study of women with surgically-correctable~     stress urinary incontinence who undergo a TOT-sling operative procedure.~   "
138610|NCT01752998|"~     Individuals will be recruited by posted advertisements in the waiting rooms of the PCP~     offices and by physician referral. After an initial phone screen, research staff will meet~     with interested individuals in their PCP offices for informed consent, baseline interview and~     randomization. Participants will be randomized into a Health Education study arm, and receive~     7 individual sessions on general health education, or an Intervention study arm, and receive~     7 individual sessions of the Treating Opioid Patients' Pain and Sadness (TOPPS) intervention.~   "
138611|NCT01752985|"~     The purpose of this study is to determine whether BMS-813160 will reduce the amount of~     protein loss in the urine of subjects with type 2 diabetes and diabetic kidney disease~   "
138612|NCT01752972|"~     Patients of arsenical keratosis may be treated with spirulina. Is this improvement related to~     the levels of zinc, vitamin E and linoleic acid at the site of the keratosis (palm)? To~     understand this, patients of palmer arsenical keratosis (n=10), arsenic exposed controls~     (n=10) and healthy volunteers (n=10) will be treated with spirulina powder 10 g/day orally~     for 12 weeks. Skin extracts will be collected both before and after supplementation from the~     palm and dorsum for estimation of zinc, vitamin E and linoleic acid levels.~   "
138613|NCT01752959|"~     In this prospective randomized study we aimed to compare the effects of esmolol and~     remifentanil on intraoperative bleeding surgical field conditions in nasal surgery~   "
138614|NCT01752946|"~     The purpose of this study is get to know what and how Shuxuening injection in hospital~     results in adverse events or adverse drug reactions from a cohort event monitoring.~   "
138615|NCT01752933|"~     A Phase 2 open-label, single-arm, non-randomized study in the treatment of advanced~     hepatocellular carcinoma (HCC) patients who failed prior treatment with sorafenib using a~     Simon's 2-stage design. A set minimum number of patients must demonstrate disease control at~     16 weeks to proceed to Stage 2. At Stage 2, a set number of patients must have disease~     control at 16 weeks to declare that SGI-110 is of interest in the treatment of advanced HCC~     after failure of prior sorafenib.~   "
138616|NCT01752920|"~     This is an open-label, Phase 1/2, dose escalation and signal finding study of ARQ 087~     administered to subjects with advanced solid tumors with FGFR genetic alterations, including~     intrahepatic cholangiocarcinoma (iCCA) with FGFR2 gene fusion. The study is designed to~     explore the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary~     efficacy of ARQ 087 and to define a RP2D of ARQ 087.~   "
138620|NCT01752868|"~     The purpose of this study is to determine if a combination of 10 nutritional supplements~     provide health benefits that are consistent with protection against age-related disease. All~     supplements have been shown in previous studies to have health benefits when administered~     alone. The hypothesis is that 6 months of taking 10 nutritional supplements each day will~     provide beneficial changes in healthy related measures.~   "
138621|NCT01752855|"~     A Phase 2b, open-label extension (OLE) study in rheumatoid arthritis (RA) patients designed~     to collect long-term safety, tolerability, efficacy, and immunogenicity data of the proposed~     new adalimumab formulation.~   "
138622|NCT01752842|"~     This study will test whether lowering the delivery of excess fats to the heart in persons~     with type-2 diabetes mellitus improves heart muscle function. The investigators will also~     test whether specific lipid molecular species in plasma can serve as biomarkers for diabetic~     heart disease.~   "
138623|NCT01752829|"~     The laparoscopic adjustable gastric band (LAGB) is a safe and effective surgical intervention~     for chronically obese patients who have exhausted all non-surgical weight loss treatments.~     Numerous published studies have confirmed both the safety and efficacy of the LAGB and its~     beneficial impact on obesity-associated conditions, such as type 2 diabetes, joint and back~     pain and hypertension. The A.M.I. Protector Band is a modification of an existing gastric~     band (the A.M.I. Soft Gastric Band) which has been in use since 2001 and which has been shown~     to be both safe and effective. The specific design modification is in the form of a section~     of mesh, which provides support to the gastric pouch and which further restricts food portion~     sizes. The expectation is that this will deliver optimal weight loss whilst having the~     maximum possible impact on obesity-associated conditions such as type 2 diabetes and~     hypertension. In the longer term, there is also the possibility that the Protector Band will~     reduce the incidence of band complications such as slippage and dilatation (or stretching) of~     the gastric pouch. In this study we will recruit approximately 200 patients who will then~     undergo surgical implantation of the A.M.I. Protector Band. The study participants will then~     be followed for a period of 3-years, during which time we will record weight loss, changes in~     co-morbid conditions such as diabetes and the incidence of band complications, including~     slippage and pouch dilatation.~   "
138624|NCT01752816|"~     In healthy young subjects a single bout of strength training following endurance training has~     been shown to improve markers for aerobic capacity in muscle compared to a single bout of~     endurance training alone. The present project tests the hypothesis: 12 weeks of training with~     sessions of endurance training followed by strength training is superior to endurance~     training alone for health participants 50-65 years of age. The outcome measures are maximal~     oxygen uptake and knee-extension strength.~   "
138625|NCT01752803|"~     Background: The connection between gut health and diabetes status is increasingly recognized.~     Gut microbiota composition in diabetic differs from non-diabetic individuals. Interestingly,~     the level of glucose tolerance was associated with specific microbiota that was rarely found~     in healthy individuals. Probiotics is one of the functional foods believed to mediate their~     health promoting activities through modulating the composition of the gut health. Ingestion~     of probiotics has been shown not only to influence gut microbiota composition but also the~     secretion of the gut hormones and insulin resistance in animal models with limited trials in~     human. Supplementation with probiotic has also been shown not only affect glucose~     homeostasis, but improved other diabetes related comorbidities such as obesity, hypertension,~     and hyperlipidemia.~      Objectives and hypotheses: To address this research gap, this Randomized Controlled Trial~     (RCT) is proposed to determine the efficacy of probiotic supplementations as adjuvant therapy~     to improve glucose homeostasis through modulating gut microbiota composition and gut hormones~     secretion in individuals with type 2 diabetes. We hypothesized that the probiotic~     supplementations will improve blood glucose control as well as other diabetes related~     co-morbidities in individuals with type 2 diabetes.~      Methodology: This is a double blind randomized parallel group control trial with 3 months~     probiotic supplementation or placebo. After screening the eligible subjects will be selected.~     Then, after consent taking, subjects will be randomly assigned to either receive probiotic or~     supplement for 3 months. Measurements of blood parameters including glycemic control related~     parameters, lipid profile, renal profile, and liver function tests as well as three day diet~     recall, and anthropometry measurements will take place at baseline, after 6 weeks and after~     12 months.~      Expected Outcomes: Probiotic supplementation as an adjuvant therapy would improve glucose~     homeostasis and gut health as compared to the placebo and eventually will beneficially affect~     other diabetes related conditions. This study would provide avenue to identify the~     possibility of probiotic supplementations as an adjuvant therapy in the management of type 2~     diabetes.~   "
138626|NCT01752790|"~     Crohn's disease (CD) is an incurable debilitating disorder affecting an increasing number of~     children. The etiology remains elusive, but a genetically determined aberrant immune response~     against microbiota appears to be responsible. TNFα plays a pivotal role in the cytokine~     cascade of the inflammatory process and mediates multiple processes central to the~     pathogenesis of CD. The natural history of pediatric CD is characterized by recurrent~     flare-ups that severely impair patients growth, pubertal development and nutritional status.~     Epidemiological observations have shown that the course of CD, despite conventional~     treatment, inevitably progresses to the development of severe complications and surgery.~     Infliximab is the most widely used biological agent in moderate-to-severe pediatric CD. At~     present biologics are used after the failure of conventional drugs (step-up approach) and~     represent the peak of the CD therapeutic pyramid. The early use of biologics (top-down~     approach) has been demonstrated to be effective in adults with CD. The project aims at~     evaluating if a top-down approach may achieve mucosal healing before irreversible tissue~     damage present in late CD and thus alter the natural course of the disease, compared to the~     conventional approach. The study can also add information about the safety of infliximab used~     as first-line therapy and may add data on the benefit and costs of a reversal of the~     traditional therapeutic pyramid in pediatric CD, guiding the clinician in deciding in whom,~     when and how to introduce early aggressive treatment in daily practice.~   "
138627|NCT01752777|"~     Prevention strategies that aim to test and treat people for HIV infection are undermined by~     HIV treatment non-adherence and sexually transmitted co-infections (STI). The proposed study~     will test a theory-based behavioral intervention to reduce HIV infectiousness by~     simultaneously improving HIV treatment adherence and reducing sexually transmitted~     co-infections in people living with HIV-AIDS who use alcohol and other drugs. The~     intervention is delivered in a single office-based counseling session followed by 4 cell~     phone delivered counseling sessions in a model that will be ready for immediate dissemination~     to case management and clinical services for people living with HIV/AIDS in resource~     constrained settings.~   "
138628|NCT01752764|"~     The hypothesis will be tested that fat can also increase absorption of (non)-nutrients from a~     salad. Therefore we designed the current study to show an increase in relative absorption~     (bioavailability) of (non-) nutrients from a mixed salad by adding fat containing dressing.~   "
138649|NCT01752491|"~     This is a phase 1 (first in man) study testing the safety of adding high dose ascorbate~     (vitamin C) to standard radiation and chemotherapy for initial treatment of glioblastoma~     multiforme (GBM).~   "
138630|NCT01752738|"~     Chronic kidney disease is associated with the accumulation of various metabolites, i.e.,~     uremic retention solutes. Evidence is mounting that the colonic microbiome contributes~     substantially to these uremic retention solutes. Indoxyl sulfate and p-cresyl sulfate are~     among the most extensively studied gut microbial metabolites, and are associated with~     cardiovascular disease, chronic kidney disease progression and overall mortality. Mechanisms~     governing their intestinal uptake and metabolism, however, are currently unknown. The~     investigators aim to explore these transport characteristics in depth. Therefore, colonic~     biopsies will be sampled of patients with chronic kidney disease, analyzed and compared to~     available data of healthy controls. Insights in the mechanisms controlling intestinal~     transport and metabolism of indoxyl sulfate and p-cresyl sulfate is certainly relevant as it~     might lead to novel therapeutic targets in the treatment of chronic kidney disease.~   "
138631|NCT01752725|"~     The aim of the study is the evaluation of the efficiency and safety of the new, CE-certified~     thermofu-sion and dissection instrument BiCision® in comparison with the long established~     Ultracision® Har-monic Scalpel(Ethicon)during a laparoscopic supracervical hysterectomy~     (LASH).~   "
138632|NCT01752712|"~     A significant proportion of people with schizophrenia are characterized by impaired ability~     to socially engage with others, which may reflect social aversion secondary to defeatist~     beliefs; decreased motivation for social interactions; and/or impairment in the normal~     reinforcement value of social interactions. These impairments in social function have been~     shown to be associated with social skill deficits; and decreased ability to identify and~     remember emotional facial expressions and empathize with the emotional status of others.~     Unfortunately, pharmacological interventions have limited benefits for impaired social~     function, whereas psychosocial interventions provide only partial benefit for this critical~     aspect of the illness. The development of an effective intervention for functional outcomes~     remains a central therapeutic challenge. Cognitive Behavioral Social Skills Training (CBSST)~     uses corrective feedback and reinforcement provided by successful interactions to challenge~     and reduce defeatist performance beliefs that contribute to low drive and interfere with~     social functioning. CBSST has been shown to have modest effects on social function in people~     with schizophrenia. Oxytocin plays a critical role in the regulation of normal social~     affiliative behavior; it is hypothesized to enhance social affiliation through the reduction~     of anxiety or social risk aversion; the enhancement of motivation for prosocial approach~     behavior; and/or increased modulation of the salience and processing of social cues. People~     with schizophrenia have decreased oxytocin levels, which are associated with an impaired~     ability to identify facial emotions and decreased prosocial behaviors. The study will be~     comprised of three phases: 1) 2-week Evaluation Phase; 2) 24-week Double-blind Treatment~     Phase; and 3) 3-month Follow-up Phase.~   "
138633|NCT01752699|"~     Neuropathic pain is a common condition and affecting 40 to 70% of the general population.~     Post-herpetic neuralgia is a condition almost complex and requires a multi modal treatment.~     Aim: This is a pilot proof-of-principle study designed to evaluate the use of low-dose~     methadone in post-herpetic neuralgia patients who remained refractory after first and second~     line treatment for post-herpetic neuralgia (PHN) and had indication for the association of an~     opioid agent to their current drug regimen.~   "
138634|NCT01752686|"~     This study is designed to investigate the efficacy of carboplatin, as a post-operative~     adjuvant chemotherapy for triple negative breast cancer patients who have pathologic residual~     cancer after the preoperative chemotherapy.~   "
138635|NCT01752673|"~     Medical reasoning is a form of inquiry that examines the thought processes involved in making~     medical decisions. When physicians are faced with patients' symptoms or signs, their thought~     processes follow either direct shortcuts to suspect a diagnosis or go into a deeper and more~     analytic process to reach a diagnosis. The second pathway is less prone to biases and errors.~     This study explores whether the use of an interactive visual display of probabilities of~     pulmonary embolism generated from positive or negative test results will increase the~     adherence to evidence based guidelines in the diagnosis of pulmonary embolism.~   "
138636|NCT01752660|"~     In the last decade physical exercise has become an accepted and integrated part of~     rehabilitation in patients with multiple sclerosis (MS). However, no studies have evaluated~     whether the most severely disabled patients can tolerate and benefit from exercise therapy.~     The purpose of this study is therefore to evaluate the feasibility of endurance training in~     severely disabled patients with MS.~   "
138637|NCT01752647|"~     This prospective cohort trial was planned to assess the feasibility of establishing a lung~     cancer screening program in Russian Federation using low-dose CT scanning in asymptomatic~     patients with at least a 30 pack-year history of cigarette smoking.~   "
138638|NCT01752634|"~     This study is to provide 24 - 52 week efficacy, safety and tolerability data to support the~     registration of the secukinumab (AIN457) prefilled syringe (PFS) for subcutaneous self~     administration in subjects with active PsA despite current or previous NSAID, DMARD and/or~     anti-TNFα therapy. An additional 4 years of long-term efficacy and safety data will be~     collected during the post Week 52 period of the study.~   "
138639|NCT01752621|"~     Aim: To assess the incidence rate, morbidity and mortality of acromegaly in Denmark.~   "
138640|NCT01752608|"~     The primary objective of this study is to evaluate the safety and efficacy of an electronic~     cognitive behavioral therapy application (eCBT Mood) compared to a control group consisting~     of a mood monitoring handheld computer application in the treatment of patients with mild to~     moderate major depressive disorder.~   "
138650|NCT01752478|"~     The purpose of this study to is to determine the incidence of post-operative ptosis in~     patients undergoing vitreoretinal surgery. An additional purpose is to identify pre-operative~     and intra-operative factors which correlate to the development of post-operative ptosis in~     vitreoretinal surgery cases.~   "
138660|NCT01752348|"~     The investigators hypothesize that the investigators can detect protein-sparing effects of~     administration of the ketone 3-hydroxybutyrate and free fatty acids during simulation of an~     acute inflammatory disease. The investigators use the infusion of endotoxin, US standard~     reference E.coli in healthy subjects as a model for inflammation / infection and to evaluate~     the effect on protein metabolism using different tracers and the investigators can measure~     the various intracellular signaling pathways of selected muscle and adipose tissue.~   "
138641|NCT01752595|"~     Auditory motor-coupling has been shown to induce neural-entrainment that can synchronize~     walking-pace with sonic tempo. The extent to which acoustical-motor entrainment can induce~     longer-term changes to physical activity behaviours remains unclear.~      Cardiac rehabilitation is essential and is associated with irrefutable mortality benefits for~     patients following an acute cardiac event. Randomized clinical trials have demonstrated a~     25-50% improvement in survival as compared to controls; however, as many as 50% of patients~     will dropout of such programs prior to completion, which undermines these morbidity and~     mortality benefits (37; 54). Research exploring ways to improve compliance to such programs~     has suggested that the incorporation of music and other such holistic, patient-centered~     interventions into a rehabilitation/exercise program is associated with improved motivation,~     endurance and satisfaction amongst cardiac rehabilitation participants. The MAINTAIN study~     has been designed to conduct a feasibility evaluation on the effects of a preference-based~     music intervention on adherence to the cardiac rehabilitation program at Toronto~     Rehabilitation Institute. The primary objective of the trial is to evaluate the feasibility~     of the implementation of such a protocol within the context of the program.~      This is a two-arm, block 2:1 randomized trial. 35 patients participating in cardiac~     rehabilitation at Toronto Rehabilitation: Cardiac Rehabilitation and Secondary Prevention~     Program will be recruited and participants will be randomized into: 1) control (standard,~     usual care); and, 2) music intervention. The randomization process employed will be a blocked~     2:1 strategy, whereby subjects are randomized to the music treatment arms 2:1. All those~     patients randomized into arm 2 will be equally randomized into either (2) preference-based~     music intervention, (3) preference-based music enhanced with RAS. The primary outcome measure~     will be weekly physical activity over a 3 month duration as measured using tri-axial~     accelerometers. We will also analyze the impact of a preference-based music intervention~     based on audio playlist utilization, self-reported sitting times ,exercise-times, on-site~     attendance to the cardiac rehabilitation program (attendance), peak oxygen uptake (VO2)~     (stress-test), and self-efficacy levels (self-efficacy questionnaires). These measures will~     be collected and analyzed throughout the course of the intervention (3 months).~   "
138642|NCT01752582|"~     The objective of this study is a comparative evaluation of BuMA stent and of EXCEL stent in~     terms of the extent of neointima formation at 3 months after implantation using OCT.~      This is a prospective, single center, randomized, open-label, non-inferiority study, which~     will enroll a total of 70 patients in Fuwai Hospital.All patients will be randomly assigned~     undergoing implantation of BuMA stent or EXCEL stent (in a 1:1 ratio). If non-inferiority was~     met, superiority test will be planned.~   "
138643|NCT01752569|"~     Cancer is a leading cause of death in individuals living with human immunodeficiency virus~     (HIV), and Kaposi's sarcoma (KS) remains the commonest HIV-associated cancer. KS is caused~     when individuals become infected with both HIV and another virus, Human herpesvirus-8~     (HHV-8). Laboratory studies have shown that HHV-8 can stimulate biological pathways within KS~     lesions which promotes their growth. Selumetinib targets these pathways and may therefore be~     a useful new therapy for KS. Phase I of this trial aims to identify the best dose for the use~     of selumetinib and investigate the effects of selumetinib treatment on the anti-viral~     treatment HIV patients receive to control HIV infection. Phase II of this trial will~     investigate how well selumetinib works as a treatment for KS at the best dose determined in~     phase I.~   "
138644|NCT01752556|"~     Primary objectives:~      The efficacy of the therapeutic decision taken by respiratory polygraphy (RP) against~     polysomnography (PSG) using the Epworth scale;~      Secondary Objective:~        1. the cost-effectiveness of diagnosis and therapeutic decision valued using the Epworth~          Scale and EuroQol 5D.~        2. effectiveness of the therapeutic decision by means of: 1) quality of life tests, 2)~          adherence and compliance to treatment, 3) blood pressure MAP, 4) biochemistry~          determinations. Design: prospective, randomized, controlled, open, parallel of~          non-inferiority. 440 patients will be randomized to diagnose and follow treatment based~          on the RP or the PSG. The follow-up will last 6 months with 4 assessments. Statistical~          analysis: We will compare the change in the Epworth scale between both arms of treatment~          through analysis of covariance. The premise of non-inferiority is -2 at the lower limit~          of 95% IC. Secondary variables will be analyzed using differences in independent means~          (or non-parametric equivalent) or Chi2 for dichotomous variables. Cost-effectiveness:~          costs generated by one and another method will be evaluated against the effectiveness of~          the primary variable using Bayesian techniques~   "
138645|NCT01752543|"~     The purpose of the present study is to evaluate the effects of a blockade of the vasopressin~     system and central hemodynamic system in heart failure (HF) patients during physical~     exercise. The significance of the vasopressin system during physical exercise is unclear. If~     vasopressin is a significant regulator of exercise hemodynamics in HF, strategies to~     intervene against activation of the V1A-receptor might be expected to improve HF symptoms and~     possibly outcome.~      The potential effects of the central hemodynamic system will be evaluated with a Swan-Ganz~     catheter. Echocardiography will be performed at rest and during submaximal working capacity~     before and during the infusion of a vasopressin receptor antagonist (conivaptan) or placebo.~     Cardiac output will be measured by thermodilution. The exercise test will be performed at 50~     % of VO2 max and hemodynamic and echocardiographic measurements will be collected. The~     exercise test will be performed on a supine multistage bicycle.~   "
138646|NCT01752530|"~     The purpose of this study is to determine the effect of computer program C8 on specific~     cognitive functions, symptoms and functional outcome compared to treatment as usual in~     children with ADHD. Furthermore, if the effect is sustained 12 and 24 weeks after training.~     In addition, it will be investigated, whether younger children benefit more from training~     than older children.~   "
138647|NCT01752517|"~     Although fist-line therapy with Cisplatin and etoposide(EP)or Carboplatin and~     etoposide(CE)and second-line therapy with topotecan has been given, patients with ED-SCLC~     still relapse and 2-year survival is less than 10%. There is no standard treatment~     recommendation for this group of patients who failed to second-line therapy and had good~     performance status. Some cytotoxic drugs for the treatment of non-small cell lung cancer,~     i.e. vinorelbine, paclitaxel, and ifosfamide, were used in refractory or recurrent SCLC~     patients. Recently, a retrospective study showed the overall response rate was 30%, the~     median progression free survival (PFS) was 6.5 months, and the median overall survival was~     10.4 months in advanced combined SCLC patients treated with first-line regimen of~     vinorelbine, ifosfamide and cisplatin (NIP). Because of the previous platinum administration~     and patient's performance status, only vinorelbine and ifosfamide (NI) are combined and used~     as third-line therapy for refractor or recurrent ED-SCLC in our lung cancer center. And this~     clinical trial is designed to prospectively investigate the efficacy and safety of NI regimen~     in refractory or recurrent ED-SCLC patients in our center.~   "
138648|NCT01752504|"~     The proposed study seeks to continue the implementation of Connect to Protect® (C2P), a~     community mobilization intervention, which entails developing coalitions to plan for and~     bring about structural changes for purposes of reducing HIV incidence and prevalence among~     youth in targeted communities at five ATN sites.~   "
138651|NCT01752465|"~     Antipsychotic medications frequently cause metabolic side-effects, such as abdominal obesity,~     high blood pressure, cholesterol abnormalities, and blood sugar dysregulation, all of which~     can lead to what is known as the Metabolic Syndrome and serious long-term cardiovascular~     health problems. Therefore, it is important that metabolic issues be addressed as part of a~     holistic approach to the mental health treatment of these patients.~      As with the general population, improving metabolic health involves lifestyle changes - i.e.,~     addressing daily habits regarding eating, physical exercise, stress and sleep management, and~     lifestyle habits such as smoking. However, there is growing recognition in the medical field~     that education is not enough for people to create meaningful and sustained lifestyle change.~     The emerging field of Integrative Health Coaching addresses this issue and provides a~     clinical framework for helping people successfully develop and achieve personalized lifestyle~     goals. The investigators have therefore decided to investigate whether health coaching~     techniques may have benefit in addressing metabolic health issues in people with psychosis~     disorders. The intent is to complement usual psychiatric and medical care, and also promote~     patient engagement in managing one's overall health.~      This study will investigate whether Integrative Health Coaching is a useful clinical tool to~     facilitate healthy lifestyle behaviour and thereby improve metabolic health in people with~     psychosis disorders.~   "
138652|NCT01752452|"~     Untreated ulnar styloid fracture may affect the outcomes of distal radial fracture patient~     treated with external fixation.~   "
138653|NCT01752439|"~     The purpose of the study is to evaluate the efficacy of the transcranial direct current~     stimulation of the primary motor cortex (M1) in patients affected by refractory chronic~     migraine (coded as 1.5.1 in the international headache classification 2nd edition, 2004) and~     medication-overuse headache (coded as 8.1) with migraine as primary headache.~   "
138654|NCT01752426|"~     The goal of this clinical research study is to learn how PCI-32765 (ibrutinib) may affect the~     life cycle of blood-cancer cells. Cancer cells will be labeled with heavy water to learn~     about their birth rates and death rates.~      Ibrutinib is a type of drug called a kinase inhibitor. Kinases are proteins inside cells that~     help cells live and grow. The study drug is designed to inhibit or block the activity of a~     type of kinase that helps blood-cancer cells live and grow. By blocking the activity of this~     specific kinase, it is possible that the study drug may kill the cancer cells or stop them~     from growing.~      Heavy water (2H2O) is a special type of water that is designed to help researchers learn how~     quickly cancer cells in the body reproduce.~   "
138655|NCT01752413|"~     The purpose of this study is to determine (1) the role of ferritin testing to screen for iron~     depletion in donors at risk of low iron levels (2) the effectiveness of oral iron replacement~     therapy on the repletion of iron stores in donors, and (3) the feasibility of blood centers~     to routinely distribute oral iron replacement therapy to donors.~   "
138656|NCT01752400|"~     This research study is a Phase II clinical trial, which tests the safety and effectiveness of~     an investigational drug to learn whether the drug works in treating a specific cancer.~     Investigational means that the drug is being studied and that research doctors are trying~     to find out more about it-such as the safest dose to use, the side effects it may cause and~     if the drug is effective for treating your type of cancer. It also means that the FDA has not~     yet approved the drug for your type of cancer or for any use outside of research studies.~      It has been found that some people with NSCLC have a change (mutation) in a certain gene~     called the ALK gene. This mutated gene helps cancer cells grow. There is a drug (crizotinib)~     that has been approved by the FDA for the treatment of people with NSCLC who have mutations~     in the ALK gene. Most people respond to crizotinib initially. Over time, however, patients~     may stop responding (become resistant) to crizotinib because of additional changes in the ALK~     gene that makes crizotinib ineffective.~      AUY922 is an investigational drug that may stop cancer cells from growing abnormally. This~     drug has been used in other research studies. Information from those other research studies~     suggests that AUY922 may be effective in killing cancer cells that have become resistant to~     drugs like crizotinib. Only participants with changes in the ALK gene will be allowed to~     participate in this study.~      The purpose of this study is to test the safety of AUY922 and determine how well AUY922~     treats participants with advanced, ALK-positive NSCLC.~   "
138657|NCT01752387|"~     The purpose of this study is to compare the surgical treatment for sportsman's hernia in our~     department to the current literature. Our hypothesis is that combined solution for the two~     major problems that cause pain in this syndrome - repair the weakness in the posterior wall~     of the inguinal canal with tension free technique (mesh repair) and reducing the muscle~     strain on the abdominal wall by cutting, partially, the tendon of the external oblique~     muscle, will shorten the time to return to full physical activity in soccer players.~   "
138658|NCT01752374|"~     We compared the prophylactic anti-emetic efficacy of ramosetron, a newly developed 5-HT3~     antagonist, granisetron and ondansetron in patients at high-risk for postoperative nausea and~     vomiting after laparoscpic abdominal surgery.~      This study was conducted to determine the efficacy of three 5-HT3 receptor antagonists in the~     prevention of PONV for laparoscopic surgery in patients receiving PCA IV.~   "
138659|NCT01752361|"~     The purpose of this study is to describe gastrointestinal (GI) motility in patients suffering~     from severe Ulcerative Colitis (UC) and to compare these results with similar results from a~     study on healthy subjects.~      Both studies are done with the use of Motilis 3D-Transit system which consists of a small~     electronic capsule ingested and detected by a receiver carried by the patient. Position and~     orientation of the capsule are interpreted by dedicated computer software and transit times,~     progression velocity and contraction frequencies can be revealed.~      The study is mainly descriptive and is designed to test and evaluate the usefulness of the~     Motilis 3D Transit system in UC patients and to tell us more about GI motility during severe~     inflammation.~      Motilis 3D-Transit system gives us a unique chance to study the gastrointestinal canal as a~     whole during severe illness.~      We expect to include 20 patients suffering from severe UC admitted to Hospital with the~     purpose of getting medical treatment. We do not expect any drop out, but in case of drop out~     a new patient will be included.~   "
138703|NCT01751789|"~     The purpose of this study is to determine whether, for individuals in inpatient opioid~     detoxification, linking to outpatient Suboxone treatment increases treatment adherence and~     reduces relapse to illicit opioid use.~   "
138661|NCT01752335|"~     The purpose of this study is to determine whether tocilizumab changes the cardiovascular risk~     factors on patients with arthritis rheumatoid.~      Study hypothesis: the IL-6 contributes to increase the cardiovascular risk factors of~     patients with rheumatoid arthritis because it produces systemic effects as increasing weight~     and atherogenic body fat, changing energy homeostasis and inducing the adipokines production~     and the insulin resistence.~   "
138662|NCT01752322|"~     The purpose of this trial is to investigate the efficacy and safety of lidocaine 5% medicated~     plaster in localized chronic post-operative neuropathic pain in comparison to placebo~     plaster.~   "
138663|NCT01752309|"~     Rheumatoid arthritis a chronic and progressive inflammatory disease characterized by synovial~     membrane inflammation, possibly leading to destruction of joints. To start early with a~     combination therapy results in a better outcome for patients. Using ultrasonography it is~     possible to detect clinically and radiographically absent synovitis and erosions. However, it~     is unclear whether or not these findings have predictive value in these patients regarding~     disease activity or radiographical progression.~   "
138664|NCT01752296|"~     Mucopolysaccharidosis IV, also known as MPS IV or Morquio disease, is a rare autosomal~     recessive genetic lysosomal storage disorder. Research thus far regarding lysosomal storage~     diseases (LSDs) in general, including Morquio, has primarily focused on exploring the causes~     of and finding a treatment for the physical aspects of the various diseases. Less attention~     has been paid to the psychological or emotional toll of these diseases, whether they are~     direct symptoms of the diseases themselves or reactions to living with a chronic progressive~     disease.~      It is well established in the health psychology literature, however, that the interaction~     between our physical health and our psychological health is bidirectional; that is, just as~     our physical health affects us emotionally (e.g. chronic pain can contribute to depression),~     so can our psychological health affect us physically (e.g. anxiety can contribute to feelings~     of chest pain). It is thus critically important to pay attention to the emotional and~     psychological symptoms associated with all lysosomal storage diseases, including Morquio, and~     expand our treatment standard of care to include mental health treatment, if necessary.~      The first step in understanding and treating psychological conditions in Morquio disease is~     determining the natural occurrence of psychological symptoms in this population in comparison~     with non-medical populations. As little has been done in this regard, a pilot study~     documenting the occurrence rate of psychological issues and overall quality of life in~     patients with Morquio is the first item in order and will be the focus of this study.~      Approximately 20 patients with Morquio disease will be invited to participate, recruited~     through Emory's Lysosomal Storage Disease Center, as well as through attendance at Morquio~     support groups and relevant regional, national and/or international meetings. Once consented,~     patients will be asked to complete three different self-report questionnaires, including the~     Achenbach System of Empirically Based Assessment (ASEBA) Adult Self-Report (ASR) or Older~     Adult Self-Report (OASR) questionnaire, the Short Form 36-item Health Questionnaire (SF-36),~     and the Brief Pain Inventory (BPI). Group aggregate data only will be reported; individual~     questionnaire content and results will be held confidential, except as in accordance with~     Georgia law relating to reporting of child or elder abuse, suicidal and/or homicidal intent.~     Completion of these questionnaires will complete subjects' participation in this pilot study.~   "
138665|NCT01752283|"~     The study is aimed to investigate the safety and feasibility of Video-assisted thyroidectomy~     under hypnosis in comparison to general anesthesia~   "
138666|NCT01752270|"~     Polycystic Ovary Syndrome is the most common endocrine disorder in women, is estimated to~     affect more than 5% of the population and is associated with chronically elevated serum~     androgen concentrations.Evidence suggests that polycystic ovary syndrome has a negative~     impact on pregnancy outcomes, with an increased risk of gestational diabetes, hypertensive~     disease during pregnancy,and preterm birth,which is partially related with the~     hyperandrogenic environment.Diane-35 has been proved to be the most effective anti-androgenic~     drug.At present, there is no direct evidence that Diane-35 has a positive effect on the~     clinical outcome of polycystic ovary syndrome patients undergoing In-vitro~     fertilization/Intracytoplasmic sperm injection.~   "
138667|NCT01752257|"~     The purpose of this pilot study is to determine the prevalence of markers of chronic and~     cycling hypoxia and reactive species stress (oxidative and nitrosative) in the melanoma tumor~     microenvironment. The study is based around four cornerstone features of the pathologic~     microenvironment - Hypoxia, Reactive Species (reactive oxygen and nitrogen species), HIF-1~     and VEGF, which the investigators term the HRHV axis. Patients with in-transit melanoma (AJCC~     Stage IIIB or IIIC) (1) will be administered the hypoxia marker drug, EF5, 24 hr prior to~     isolated limb infusion (ILI) or hyperthermic isolated limb perfusion (HILP). Tumor biopsies~     will be performed just prior to ILI or HILP, at the 30 minute time point during ILI (or 60~     minute time point during HILP), AND 24 hours after ILI or HILP. Tissues obtained will be snap~     frozen and subsequently analyzed for EF5 binding. Immunohistochemical analysis of a cohort of~     immunohistochemical and urine markers that depict the HRHV axis will also be examined. The~     association of the markers with the presence of hypoxia, as determined by EF5 positivity,~     will be determined. Data from this pilot study will be used to establish the prevalence of~     markers of the HRHV axis in melanoma. This information will be crucial for future human~     trials in which the HRHV axis is therapeutically targeted.~   "
138668|NCT01752244|"~     Obesity-induced chronic inflammation is a key component of the pathogenesis of insulin~     resistance. Mounting evidence has demonstrated anti-inflammatory characteristics for vitamin~     D. Although analogues of vitamin D3 have extensively been used in the treatment of various~     chronic inflammatory diseases, to our knowledge, no such research is conducted in regards~     with obesity. The aim of this double blind clinical trial study is to investigate whether~     alphacalcidol treatment in obese subjects can affect the insulin resistance. Moreover, we~     will evaluate the pathways of Vitamin D receptor (VDR), Peroxisome proliferator-activated~     receptor gamma (PPARγ) and eroxisome proliferator-activated receptor- coactivator-1 α (PGC1α)~     gene expressions which may lead to insulin resistance following treatment with either~     alphacalcidol or placebo.~   "
138669|NCT01752231|"~     This pilot clinical trial studies dynamic contrast enhanced (DCE)-magnetic resonance imaging~     (MRI) in diagnosing cancer. New diagnostic procedures, such as DCE-MRI may help find and~     diagnose cancer~   "
138670|NCT01752218|"~     The purpose of this open, prospective study is to address the effectiveness and precision of~     the VICTUS™ Femtosecond Laser Platform-assisted astigmatic keratotomy after~     femtolaser-assisted cataract surgery.~   "
138671|NCT01752205|"~     The purpose of this study is to test the safety and effectiveness of erlotinib and~     chemoradiotherapy in patients with unresectable esophageal or gastro-esophageal squamous~     cancer .~   "
138704|NCT01751776|"~     To evaluate the safety and tolerability of multiple doses of BI 655064 administered~     subcutaneously in healthy volunteers (HVs) and in rheumatoid arthritis (RA) patients. To~     explore the pharmacokinetic (PK) and pharmacodynamic (PD) parameters of multiple doses of BI~     655064 in healthy volunteers (HVs) and rheumatoid arthritis (RA) patients. To assess clinical~     effect of BI 655064 in RA patients with prior inadequate response to methotrexate (MTX) after~     12 weeks of treatment~   "
138672|NCT01752192|"~     The idea behind the Teledi@log consortium is to develop tele-rehabilitation concepts and~     technologies so that all types of heart disease patients, regardless of degree of severity,~     can be offered individual, customized and coordinated tele-rehabilitation across sectors. The~     project is innovative, breaking new ground in relation to existing national and international~     research projects in the area. The Teledi@log consortium sees its major task as developing~     and testing scenarios which can lead to a more coherent rehabilitation for heart patients in~     areas such as patient training, organization across the boundaries of the health system and~     using tele-rehabilitation technology. The Teledi@log consortium seeks to develop new~     tele-rehabilitation concepts which bring the patient closer to the health system and thereby~     promote the heart patient's rehabilitation, giving the patient and their families a more~     active role via new tele-rehabilitation technologies.The hypothesis of the study is that~     heart patients participating in a telerehabilitation program will have a higher quality of~     life compared to heart patients following traditional rehabilitation activities.~   "
138673|NCT01752179|"~     Kinesio taping is a novel method which recently has emerged as a viable option to treat of~     various musculoskeletal and neuromuscular deficits. The application of tape to injured soft~     tissues and joints provides support and protection for these structures. Many different~     techniques are used for injury prevention, treatment, rehabilitation, proprioception and~     sport. Elastic adhesive tape may be used to unload Myofacial Trigger Points (MTrPs), A~     trigger point can be located in fascia, ligaments, muscles, and tendons; however, MTrPs are~     also found in skeletal muscles and/or their fascia. An MTrP is a hyperirritable spot,~     associated with a taut band of a skeletal muscle that is painful on compression or stretch,~     and that can give rise to a typical referred pain pattern as well as autonomic phenomena. The~     use of tape along muscle to unload affected soft tissue seems to be effective in the~     treatment of trigger points by inhibiting overactive muscle, changing the orientation of~     fascia and a proprioceptive effect. The purpose of study was to determine the efficacy of~     Kinesio taping application on trigger point of piriformis muscle.~   "
138674|NCT01752166|"~     The purpose of this study is to validate clinical performance (i.e. estimated sensitivity and~     specificity) of the T2 Candida test on the T2 DX Instrument compared to blood culture results~     and/or known Candida positive status of prospectively collected and contrived (i.e.~     Candida-spiked) clinical specimens.~   "
138675|NCT01752153|"~     A wide spectrum of immune abnormalities has been described by numerous studies involving~     β-thalassemic patients with multiple transfusions. The abnormalities observed are both~     quantitative and functional, and concern several components of the immune response.~     Flavonoids are phenolic compounds widely distributed in plants, which were reported to exert~     multiple biological effects, including antioxidant and free radical scavenging abilities.~     Silymarin, a flavonolignan complex isolated from milk thistle (Silybum marianum L. Gaertn),~     have been classified as cytoprotective, antioxidant, anti-inflammatory, and especially as~     hepatoprotective agents. Silymarin is already being used clinically for treatment of liver~     diseases.It is considered safe and well-tolerated, with reported adverse events similar to~     placebo. Several studies have also reported immunomodulatory actions of silymarin. It~     increases lymphocyte proliferation, interferon gamma, interleukin (IL)-4 and IL-10 secretions~     by stimulated lymphocytes in a dose-dependent manner. It has been shown that in vitro~     treatment of peripheral blood mononuclear cells with silymarin causes restoration of the~     thiol status and increases in T cell proliferation and activation. Because reactive oxygen~     species and iron overload play important roles in the pathophysiology of thalassemia,~     silymarin may be an effective therapy due to its antioxidant, immunomodulatory,~     cytoprotective and iron chelating activities. The present study designed to investigate the~     therapeutic activity of orally administered silymarin for treatment of β-thalassemia major, a~     well-known and prevalent disease in Iran, which is associated with oxidative stress, iron~     overload and immune abnormalities.~   "
138676|NCT01752140|"~     In this study, the investigators aim to determine if the Vienna nomogram increases the~     detection rate of TRUS-guided prostate biopsies by conducting a prospective randomized study~     comparing the Vienna nomogram with a 10-core biopsy protocol.~   "
138677|NCT01752127|"~     The newer generation ZES (Medtronic, Minneapolis, MN, Resolute Integrity) and EES (Abbott~     Vascular, Abbott Park, Illinois, Xience Prime) were introduced to South Korea. Although these~     are thought to be superior in effect and stability compared to ZES and EES of previous~     generation, there are few clinical data regarding the high risk groups of diabetes patients~     or small vessels lesion. Moreover, looking at the 8.3% of restenosis in Resolute All Comer~     study (23% diabetes), the investigators could not know the outcome in high risk patients such~     as diabetes or small vessels lesion. Therefore, the aim of this study is to investigate the~     effectiveness and safety of Resolute Integrity or Xience Prime in diabetes or small vessels~     lesion patients.~   "
138678|NCT01752114|"~     This study is intended to determine the positive predictive value (PPV) and negative~     predictive value (NPV) of the multiprotein classifier based on the observed study prevalence~     of Non-Small Cell Lung Cancer (NSCLC) in the study participants.~   "
138679|NCT01752101|"~     The primary objective is to identify a panel of plasma and/or serum proteins that~     differentiates the absence or presence of lung malignancy in samples obtained from subjects~     enrolled in this IRB/EC approved study with pulmonary nodules.~   "
138680|NCT01752088|"~     This study is to evaluate the magnetic resonance imaging (MRI) and clinical results of~     arthroscopic repair of subscapularis tears~   "
138681|NCT01752075|"~     The REVLIMID Registry will provide safety data from a large cohort of Taiwanese patients~     treated with REVLIMID. In addition, the registry will provide efficacy data and outcomes in a~     real-world setting (versus a clinical trial).~   "
138682|NCT01752062|"~     The objective of this study is to acquire more information about what we are doing during~     pregnancy in CML patients, in order to possibly establish in the future a consensus on the~     management of patients receiving TKIs who wants to father a child or become/are pregnant.~   "
138770|NCT01750905|"~     The most promising chimeric natriuretic peptide designed and studied by our group has been~     CD-NP which has anti-fibrotic and cardioprotective properties in vivo, vitro and in normal~     volunteers and human heart failure patients. Since left ventricular assist device (LVAD) can~     not reverse remodeling of the heart whereas it can improve hemodynamics, CD-NP may be novel~     anti-fibrotic and anti-remodeling drug as co-therapy during LVAD support.~   "
138683|NCT01752049|"~     Hereditary hemorrhagic telangiectasia (HHT) is a hereditary vascular condition characterized~     by the development of abnormal connections between arteries and veins throughout the body,~     called vascular malformations. These abnormal blood vessels are referred to as arteriovenous~     malformations (AVM) if they are large and telangiectasias if they are small. Telangiectasias~     develop due to irregular growth of blood vessels.~      Anti-angiogenic therapy, such as the drug Apo-Timop, curbs the growth of new blood vessels.~     Apo-Timop is included in a class of medications called beta-blockers. Anti-angiogenic~     therapies exert their beneficial effects in a number of ways: by disabling the agents that~     activate and promote cell growth, or by directly blocking the growing blood vessel cells.~      The investigators think that anti-angiogenic therapy may lead to the shrinking of~     telangiectasia in people with HHT. The investigators hope that this study will provide us~     with proof of this concept and might lead to the development and study of anti-angiogenic~     therapies to help improve the lives of individuals with vascular malformations.~   "
138684|NCT01752036|"~     Although it is being increasingly used off protocol, there is minimal data regarding the~     efficacy of stereotactic radiosurgery to the tumor bed following surgical resection of~     metastatic lesions to the spine. The primary objective of this study is to evaluate~     radiographic local recurrence in the tumor bed following stereotactic radiosurgery compared~     to the expected rate following conventional radiation therapy.~   "
138685|NCT01752023|"~     Response rates.~      Changes in tumor blood flow.~   "
138686|NCT01752010|"~     The primary objective of this preliminary study is to compare the Tennant BioModulator with~     Transcutaneous Electrical Nerve Stimulation (TENS) and Traditional Chinese Acupuncture for~     the management of chronic pain among injured service members. The secondary objective is to~     investigate any associative effects or benefits on sleep, Post-Traumatic Stress Disorder~     (PTSD) symptoms, or depression.~   "
138687|NCT01751997|"~     This study will compare the clinical outcomes of transplants from~     family-mismatched/haploidentical donors (FMT) with transplants from 8/8-matched unrelated~     donor (MUT), which is a current gold standard donors when lacking of HLA-matched-siblings~        1. Primary objectives: Overall survival of FMT may be similar to that of MUT~        2. Secondary objectives:~           i. Comparison of disease-free survival, relapse, non-relapse mortality, immune~          reconstitution cytomegalovirus infection, and acute or chronic graft-versus-host disease~          between FMT and MUT.~           ii. Investigation of possible biomarkers related with above events after transplantation~   "
138688|NCT01751984|"~     This study will assess the LDL-C lowering efficacy and safety of ETC-1002 versus placebo in~     subjects with hypercholesterolemia and a history of statin intolerance.~   "
138689|NCT01751971|"~     This study seeks to employ advanced methods to estimate the individual factors contributing~     to sleep apnea from standard recordings made during routine clinical sleep studies. This~     study focuses on breathing control or loop gain as one of the factors contributing to sleep~     apnea. Increased levels of oxygen in the air is known to make breathing more stable by~     lowering loop gain. Here, our goal is to use a new method capable of detecting a reduction~     in loop gain with oxygen. The investigators also aim to test whether a high loop gain~     measured at baseline/placebo predicts a greater improvement in sleep apnea with oxygen~     therapy.~   "
138690|NCT01751958|"~     Evaluate radiation exposure and procedure times for continuous fluoroscopic monitoring during~     lumbar ESI~   "
138691|NCT01751945|"~     The purpose of this study is to determine whether an integrated EmONC package (community~     mobilization, training of community-based health care providers and a maternal and neonatal~     health pack) reduce perinatal and neonatal mortality.~   "
138692|NCT01751932|"~     The purpose of this study is to assess the accuracy of two continuous glucose monitoring~     devices (the Dexcom G4 Platinum and Medtronic Enlite systems) in patients with type 1~     diabetes mellitus.~   "
138693|NCT01751919|"~     1. Investigational Product~             1. Imatinib mesylate tablet 400 mg~             2. Glivec film-coated tablet 100 mg (Comparator)~        2. Expected target disease~             1. chronic myeloid leukemia~             2. Gastrointestinal stromal tumors~        3. Study design : Randomized, open-label, single dose, two-period, two-way, crossover study~             1. 36 healthy subjects, 2 groups (18 subjects/group)~             2. 2 Period (either 1-a(1 tablet) or 1-b(4 tablet))~             3. wash-out period : 14 days~        4. Evaluation on pharmacokinetics(PKs) and safety~             1. PKs : Cmax, AUClast, Tmax, AUCinf, t1/2~             2. safety : adverse events, physical examination, vital sign, ECG, Laboratory test~        5. Statistical method~             1. Demography Characteristics~             2. Pharmacokinetic parameters~             3. Safety data~   "
138694|NCT01751906|"~     The ABSORB III RCT is a prospective randomized, single-blind, multi-center trial. It is the~     pivotal trial to support the US pre-market approval (PMA) of Absorb™ Bioresorbable Vascular~     Scaffold (BVS).~      The ABSORB III includes additional two trials i.e. ABSORB III PK (pharmacokinetics) sub-study~     and ABSORB IV RCT trial which are maintained under one protocol because both trial designs~     are related, ABSORB IV is the continuation of ABSORB III and the data from ABSORB III and~     ABSORB IV will be pooled to support the ABSORB IV primary endpoint. Both the trials will~     evaluate the safety and effectiveness of Absorb BVS.~   "
138695|NCT01751893|"~     The palmar-plantar erythrodysesthesia (PPE) is the only clinical adverse event that commonly~     occurs with capecitabine and/or pegylated liposomal doxorubicin treatment and it warrants~     special attention because it is the most common dose-limiting toxicity. this study is~     designed to test the effectiveness of a henna treatment protocol in the management of~     capecitabine and/or pegylated liposomal doxorubicin induced palmar-plantar~     erythrodysesthesia.~   "
138705|NCT01751763|"~     Radical hepatic resection represents one of the treatment options offering a prospect for~     cure with 5-year survival rates up to 50%. However, unintentionally, quite a proportion of~     these radical resection actually turned out to be non-radical in nature. For these patients~     who actually received non-radical resection, their by year survival rates were much lower~     than those who received radical hepatectomy. In this prospective, non-interventional,~     multi-center study, we are planning to observe the patient characteristics of Hepatocellular~     carcinoma (HCC) patients who have residual disease after resection with curative intent, as~     well as treatment pattern, safety and effectiveness of sorafenib for these patients.~   "
138771|NCT01750892|"~     This study is looking at ways to help young people with chronic health conditions take better~     care of their health and find an adult doctor.~   "
138696|NCT01751880|"~     Gastric cancer is a major health issue and one of the most common malignance in Korea. With~     the popularization of cancer screenings and increasing the average lifespan, the number of~     gastric cancer patients is increased. In the past, most of the research were concerned with~     survival and recovery after cancer surgery. However, as the medical technology had been~     developed and recovery rate and survival rate of cancer patients had risen, the patients~     wanted to return to a daily life and desire for participation for leisure. In other words,~     the patients who underwent surgery wants to maintain a high quality of life(QOL) level as~     like prior to cancer surgery.~      There are many reports on the effect of the exercise program after cancer surgery. In~     addition, exercise program was associated with improving the QOL and functional recovery,~     decreasing a mood of depression, maintaining a muscle mass and improving the survival rate.~      However, the subject patients of previous studies were Western people. Therefore, The results~     were not disclosed whether the exercise program suited to the body characteristics of Korean~     people. Furthermore there was no exercise program studies for the gastric cancer patients.~      Medical service for cancer patients care should include not only diagnosis, treatment as like~     surgery but efforts on enhancing the quality of life. In other words, post-management~     education and management program as like exercise program are necessary for the cancer~     patients after surgery. So, the research about how to practice the exercise program and how~     to evaluate the effect on the recovery is needed.~   "
138697|NCT01751867|"~     The purpose of this study is to evaluate the effectiveness and safety of decitabine in the~     treatment of myelodysplastic syndrome (name of a group of conditions that occur when the~     blood-forming cells in the bone marrow are damaged) in Chinese patients.~   "
138698|NCT01751854|"~     The information derived from this study will be critical to establishing appropriate~     rehabilitative interventions post-stroke. In particular, traditional use of pharmacological~     agents to alter motor function post-stroke is directed primarily at reducing the positive~     signs following upper motor neuron lesion, in particular spasticity, or enhanced,~     velocity-dependent stretch reflex responses to imposed stretch. While pharmacological~     management of spasticity certainly suppresses clinical and quantitative measures of~     hypertonia, there is little improvement in functional performance. In contrast, preliminary~     data on the administration of 5HT agents following neurological injury indicates an increase~     in motor performance (Pariente 2001) and recovery (Dam 1996), despite an increase in spastic~     motor activity (Stolp-Smith 1999; see Preliminary Data below). Understanding methods to~     maximize function following stroke despite potential, short-term increases in spastic motor~     activity may improve therapeutic intervention strategies. The general objective of this study~     is therefore to:~        1. quantify the effects of short-term SSRI administration on voluntary and spastic motor~          behaviors in individuals with chronic spastic hemiparesis,~        2. identify the changes in impairments and functional recovery of walking ability during~          BWSTT with the presence or absence of SSRIs.~   "
138699|NCT01751841|"~     Prospective/Retrospective data analysis, chart reviews and clinical outcomes of minimally~     invasive spine surgery~   "
138700|NCT01751828|"~     The long-term goal is to determine if decreased blood flow to the brain (cerebral~     hypoperfusion) is predictive of antidepressant outcomes in late-life depression (LLD).~     Studies in younger adult report that successful antidepressant treatment is associated with~     increases in cerebral blood flow, with no change in blood flow being observed in~     nonresponders. Thus cerebral hypoperfusion may be a biomarker of poor response to~     antidepressants. In LLD, this may occur secondarily to underlying vascular disease. If LLD is~     characterized by cerebral hypoperfusion and it does have predictive power to identify~     individuals who will poorly respond to conventional antidepressants, this would support the~     study of interventions that improve cerebral perfusion and may improve antidepressant~     outcomes.~      As an initial step in this research, this pilot study will utilize MRI to examine if resting~     blood flow deficits predict and persist with antidepressant nonremission in an elderly~     population. The rationale for this proposal is that it will guide the design and power~     requirements of a larger, definitive trial examining the relationship between cerebral~     perfusion and depression outcomes. Importantly, support for this mechanism being linked to~     LLD would also support studies examining the antidepressant efficacy of drugs that may~     improve cerebral perfusion.~      The primary purpose of this pilot study is a) to demonstrate feasibility by recruiting,~     scanning, and treating depressed elders; and b) to acquire preliminary data for competitive~     grant submissions.~      SPECIFIC AIM: To use MRI to test for differences in cerebral perfusion between individuals~     who do and do not remit to a 8-week course of sertraline.~   "
138701|NCT01751815|"~     Background:~      Colonoscopy is often regarded as a painful and unpleasant procedure. Transcutaneous Electric~     Nerve Stimulation on Acupoints (Acu-TENS) is a non-invasive modality that has been used~     successfully to treat pain of various origins, but few good-quality studies have evaluated~     its role in treating pain and anxiety during colonoscopy.~      Objective:~      To investigate the efficacy of Acu-TENS in reducing procedure-related pain and the~     consumption of sedatives/analgesics during colonoscopy.~      Design:~      Prospective, randomized, placebo-controlled study.~      Subjects:~      One hundred and twenty eight consecutive patients undergoing first-time elective day-case~     colonoscopy without previous experience of acupuncture/Acu-TENS will be recruited.~      Interventions:~      Patients will be randomized to receive either 45 minutes of Acu-TENS or placebo-TENS before~     colonoscopy. The acupoints relevant to the treatment of abdominal pain and distension,~     including Zusanli, Hegu, Neiguan, Tianshu, and Dachangshu will be used. For the placebo-TENS~     group, a non-conductive plastic film will be placed between the acupoint and the electrode so~     that no current will be transmitted. Acu-TENS and placebo-TENS will be continued throughout~     colonoscopy. A mixture of Propofol and Alfentanil, delivered by a patient-controlled syringe~     pump, will be used for sedation/analgesia in both groups.~      Outcome measures:~      Primary outcome: doses of patient-controlled sedation/analgesia consumed. Secondary outcomes:~     pain and satisfaction scores according to a visual analog scale, cecal intubation rate/time,~     and episodes of hypotension/desaturation.~   "
138702|NCT01751802|"~     The purpose of this research study is to gather scientific information about the~     effectiveness and safety of the study drug, Ecopipam (PSYRX 101), for the treatment of~     self-injurious behaviors when compared with the effectiveness and safety of placebo (inactive~     substance) in subjects with Lesch-Nyhan Disease.~   "
138706|NCT01751750|"~     The objectives of this study are the following: 1) to confirm that the administration of~     grape juice, resveratrol, and grape seed polyphenol extract results in a similar plasma and~     urinary metabolic profile in aged humans compared to rats, 2) to confirm that a combined~     administration of grape juice, resveratrol, and grape seed polyphenol extract result in a~     similar plasma and urinary metabolic profile in adults with tendencies toward metabolic~     syndrome compared to non-obese healthy humans, and 3) to identify the anti-inflammatory~     effects of the combined administration of grape juice, resveratrol, and grape seed polyphenol~     extract.~   "
138707|NCT01751737|"~     This research study will access the using of a radiotracer, 18F-choline PET/CT and MRI for~     prostate cancer in patients undergoing diagnostic prostate biopsy. Patients receive MRI~     guided prostate biopsies and metabolomic profiling of prostate biopsy tissues.~   "
138708|NCT01751724|"~     Most premature infants require mechanical ventilation for prolonged periods of time and a~     significant proportion of them develop Bronchopulmonary Dysplasia (BPD). Caffeine is a~     stimulant of the respiratory center and has been used for the treatment of Apnea of~     Prematurity in infants not requiring mechanical ventilation or to facilitate weaning from~     mechanical ventilation by starting therapy shortly before extubation. Recently the use of~     Caffeine in ventilated infants has been initiated earlier because of the reported reduction~     in BPD. However there is paucity of data supporting this practice.~      Because protracted mechanical ventilation and supplemental oxygen increase the risk of~     developing BPD, a therapy that would facilitate the reduction of the respiratory support and~     shorten its duration is desirable. Therefore, it is of importance to evaluate the effects of~     early Caffeine initiation and administration during the course of mechanical ventilation in~     preterm infants by means of a randomized placebo-controlled trial.~      Hypothesis:~      The primary hypothesis of this study is that early use of caffeine in mechanically ventilated~     preterm infants will reduce the time to first elective extubation and secondarily, that this~     will reduce the total duration of mechanical ventilation and oxygen supplementation, and~     reduce the incidence and severity of BPD.~      Objective:~      The objective of this trial is to evaluate the effects of early caffeine use during~     mechanical ventilation on the time to first elective extubation, total duration of mechanical~     ventilation and oxygen supplementation, and the incidence of BPD.~      Study Design:~      This will be a single-center prospective, randomized, double-blind, placebo controlled~     clinical trial.~      Population:~      Premature neonates born between 23 and 30 completed weeks of gestation, who require~     mechanical ventilation within the first 5 days of life will be enrolled. Infants with major~     congenital anomalies or small for gestational age will be excluded.~      Methods:~      Infants will be randomized within the first 5 days to receive a study drug consisting of~     either blinded Caffeine citrate or blinded Placebo (equivalent volume of normal saline).~     Infants will continue to receive the study drug until the first elective extubation.~   "
138709|NCT01751698|"~     Adaptive Interventions for Minimally Verbal Children with ASD in the Community, seeks support~     to construct an adaptive intervention that utilizes two efficacious interventions (JASP-EMT~     and CORE- DTT) that have shown promise for optimizing the number of unique socially~     communicative and spontaneously spoken words in minimally verbal children with ASD. The study~     utilizes a novel sequential multiple assignment-randomized trial to evaluate and construct an~     optimal adaptive intervention. A total of 192 minimally verbal school aged children with an~     Autism Spectrum Disorder (aged 5 to 8 years of age) will participate across four sites,~     University of California Los Angeles, University of Rochester, Vanderbilt University and~     Weill Cornell Medical Center with methodological and statistical support from University of~     Michigan.~   "
138710|NCT01751685|"~     We propose to conduct a randomized, controlled trial among 100 men and women aged 60 or older~     with hyperkyphosis to an exercise intervention that includes kyphosis-specific spinal muscle~     strengthening exercises compared to a usual care control group. The study will be conducted~     in five waves,with 10 participants in the exercise intervention and 10 participants in the~     control group in each wave.~   "
138711|NCT01751672|"~     The purposes of this study are to: 1) implement a high fidelity Screening, Brief Intervention~     and Referral to Treatment (SBIRT) protocol with computerized screening technology into three~     primary care clinics in urban Philadelphia; 2) conduct a randomized controlled trial to~     determine if an expanded SBIRT (SBIRT+) will help patients attend more specialty substance~     abuse treatment sessions and reduce substance use compared to SBIRT; 3) conduct a process~     evaluation of SBIRT+ at the three collaborating clinics consisting of focus groups and~     structured interviews to assess implementation barriers and workforce attitudinal shifts; and~     4) provide an excellent clinical research training environment for undergraduate and graduate~     students from Lincoln University.~   "
138712|NCT01751659|"~     This is a three phase study designed to examine clinician behaviors with regard to~     recommending and prescribing pre-exposure prophylaxis (PrEP) as a primary Human~     Immunodeficiency Virus (HIV) prevention strategy, and to identify knowledge-related and~     attitudinal factors associated with these behaviors. Each phase consists of the following:~      Phase 1: Semi-structured face-to-face or telephone interviews of ATN-affiliated clinicians.~     Approximately 10 clinicians will be interviewed.~      Phase 2: Development of a new theory-based survey instrument and cognitive interview testing~     of this survey. Approximately five clinicians (of those who participated in Phase 1) will be~     interviewed.~      Phase 3: Administration of the newly developed survey to ATN-affiliated clinicians.~     Approximately 60 clinicians will be interviewed.~   "
138713|NCT01751646|"~     This is a 48 week randomized double-blind, placebo-controlled prospective cohort study of~     adolescents and young adults with HIV infection in the ATN who are currently being treated~     with cART that includes TDF as one component of the regimen that includes at least three Food~     and Drug Administration (FDA)-approved ARVs for at least 180 days.~   "
138714|NCT01751633|"~     Thoracolumbar fractures are the most common spinal fractures with an average annual incidence~     between 18 and 30 per 100'000 inhabitants. The majority of these fractures are AO type A3~     (burst fractures). Although patients with burst fractures report a reduced quality of life~     and chronic pain, there is no clear evidence whether surgical or conservative treatment offer~     better functional and back-pain related outcomes. The indications for the selection of an~     ideal treatment for these fractures without neurological deficits remain controversial. The~     purpose of this study is to evaluate whether patients with thoracolumbar fractures without~     neurological deficit being surgically treated show faster recovery and better improvement of~     function than patients being conservatively treated.~   "
138715|NCT01751620|"~     The proposed study is a two-group randomized repeated measures design that will examine the~     efficacy of Project ACCEPT (Adolescents Coping, Connecting, Empowering and Protecting~     Together) to improve engagement in care among youth newly diagnosed with HIV at five AMTU~     sites across the United States. Youth will be randomized into one of two study arms; Project~     ACCEPT, the intervention, or HEALTH, the health education attention-controlled comparison~     condition. Both arms consist of two individual sessions followed by six group sessions and a~     final individual session which is expected to take approximately nine weeks after which youth~     will have four follow-up visits at the following time points:~        -  post intervention (immediately after the last session);~        -  3 months post the last session;~        -  6 months post the last session; and~        -  12 months post the last session. The trial will be repeated in up to three waves.~   "
138717|NCT01751594|"~     The proposed research study aims to conduct a culturally-based secondary prevention~     intervention targeted toward HIV-positive Black young men who have sex with men (B-YMSM) to~     explore (1) feasibility and acceptability (Trial 1 and Trial 2) and (2) evidence of potential~     efficacy (Trial 2). The primary outcomes will be health promotion behaviors (i.e., treatment~     adherence, sexual risk reduction, reduction in substance use behaviors, and HIV status~     disclosure). Psychosocial factors (i.e. self-esteem, critical consciousness, and~     socio-political awareness) will be examined as secondary outcomes.~   "
138718|NCT01751581|"~     Each 4-day period will follow the same protocol. Basically, for the entire study, we will~     prepare all of the subject's food and will require him or her to eat all of the food that we~     give at the times we tell them to eat. The subject will arrive at the hospital on the evening~     of day 1, and become inpatients. On day 2, the subject will be permitted to leave the~     hospital campus under the supervision of the research staff. On day 3, they will be required~     to stay in a small room called a metabolic chamber for 24 hours. This room measures how many~     calories you burn in one day. On day 4, we will measure the subject's energy expenditure in~     response to a breakfast meal. They will be given breakfast and the number of calories that~     they burn after that meal will be measured over a 6-hour period. Then the subject will be~     discharged at the end of the test. The 2 study periods will differ only in bedtimes and~     wakeup times. During one period, the subject will go to bed at 1 am and wake up at 5 am and~     during the other period they will go to bed at 11 pm and wake up at 7 am.~   "
138719|NCT01751568|"~     People who are infected with HIV and tuberculosis (TB) need to receive medications that treat~     both diseases safely and effectively. This study will enroll infants and children infected~     with HIV and TB and evaluate the safety and tolerance of an antiretroviral (ARV) treatment~     regimen for HIV that contains raltegravir when administered with a TB treatment regimen that~     includes rifampicin. Study researchers will also determine the most effective dose of~     raltegravir for infants and children when it is taken with rifampicin.~   "
138720|NCT01751555|"~     This is a Phase 4 single-arm, post-marketing clinical trial evaluating the efficacy and~     safety of tenofovir disoproxil fumarate, lamivudine and efavirenz in adults with human~     immunodeficiency virus-1 and hepatitis B virus coinfection.~   "
138721|NCT01751542|"~     Randomized clinical trial comparing standard residential substance abuse treatment to~     standard residential treatment plus Mindfulness and Acceptance Group Therapy for substance~     use.~   "
138722|NCT01751529|"~     This prospective pilot study is designed to evaluate the accuracy of contrast-enhanced~     ultrasound when used to evaluate renal lesions in two different populations; patients with~     known renal tumors (Cohort 1) and patients with a risk factor for renal malignancy in whom~     their screening ultrasound shows an indeterminate or possibly malignant renal mass (Cohort~     2).~   "
138723|NCT01751516|"~     This is a single arm, single center pilot study of 40 patients with uT3N0 or uT1-3N+ rectal~     cancer receiving pre-operative chemoradiation. Subjects will undergo PET/MRI scans before and~     after surgery.~   "
138724|NCT01751503|"~     Foot drop deformity is a life limiting condition characterized by loss of ankle dorsiflexion~     and eversion. Main condition leading to drop foot condition include irrecoverable muscle and~     nerve injuries, poliomyelitis, drug poisoning, strokes, cerebral palsy, Charcot - Marie -~     Tooth disease, meningomyelocele, club foot, Friedreich's ataxia and Leprosy (1-4).~      Anterior transposition of Posterior tibialis tendon (PTT) is the gold standard for surgical~     restoration of functional dorsiflexion of a permanently paralyzed foot (1, 4-10). Two methods~     of rerouting the posterior tibialis tendon have been reported, one through the interosseous~     membrane i.e. Interosseous route (7, 10) and second subcutaneously around the medial side of~     tibia i.e. Extramembranous or circumtibial route (11-13). Both these techniques have been~     widely described in literature (4-16) and are being extensively used in surgical management~     of foot drop. The selection of technique depends on surgeon choice and patient factors.~      There is a clinical equipoise with regards to these two techniques of Tibialis posterior~     tendon transfer and through our study we aim to compare the clinical and functional outcomes~     of these two techniques. There are no studies in literature which compare the clinical and~     functional outcomes with regards to both these methods. Although there are many studies to~     demonstrate the functional and clinical effectiveness of the respective procedures, there is~     a paucity of clinical trials comparing these two surgical techniques with regards to clinical~     and functional outcomes. Furthermore there are no head to head clinical trials to compare the~     outcomes with regards to these two methods of Tibialis Posterior tendon transfer (Medline~     search dated 03/03/ 2012)~      we propose to compare the clinical and functional outcomes with regards to the two techniques~     i.e extra membranous and Interosseous technique of Tibialis Posterior tendon transfer~     performed in patients with foot drop as a result of nerve palsy.~      Through our prospective randomized trial we aim to answer the research question, whether one~     method has any superior outcome over the other?~   "
138725|NCT01751490|"~     We will conduct a randomised clinical trial with the primary aim of determining whether~     surgical intervention followed by physiotherapy rehabilitation improves pain and disability~     outcomes more than physiotherapy rehabilitation alone in patients suffering from atraumatic~     shoulder instability associated with bony/capsulolabral damage. The results of this study~     will have direct and immediate impact on clinical decision making by establishing~     definitively if patients presenting with joint damage associated with atraumatic shoulder~     instability should be referred for surgery before commencing physiotherapy rehabilitation.~     The results of this study may also result in significant cost savings to the National Health~     Service if surgical intervention for atraumatic shoulder instability does not result in~     greater improvement than physiotherapy alone.~   "
138726|NCT01751477|"~     Necrotizing enterocolitis (NEC) is one of the most devastating gastrointestinal emergencies~     in preterm neonates and a leading cause of death and morbidity.~      The pathogenesis of NEC remains largely unclear, but it is widely considered as a~     multifactorial disease. Prematurity, enteral feeding, bacterial colonisation of the gut and~     intestinal ischemia have been proposed as major risk factors.~      Probiotics may prevent NEC by improving the maturity and function of the gut mucosal barrier,~     modulating the immune system, promoting colonization of the gut with beneficial organisms and~     preventing colonization by pathogens.~      A variety of clinical trials have evaluated the effect of different probiotic preparations on~     the occurrence of NEC in preterm infants. The results of recent metaanalyses suggest a~     benefit of probiotic bacteria in reducing the incidence of NEC and propose a change of~     practice.~      The aim of the study is to evaluate the efficacy of the probiotic preparation Infloran® in~     reducing the incidence of NEC after implementation in clinical routine in preterm (< 34 weeks~     gestational age) very low birth weight infants compared to a historical cohort.~   "
138727|NCT01751464|"~     This is a feasibility study of a WrapAround Case Management Program for Youth Injured by~     Violence. Youth (aged 10-24) who have been injured by violence and visit the emergency~     department will be offered a support worker who will provide WrapAround Case Management. This~     study is designed to assess the feasibility of recruitment, enrollment and follow-up.~   "
138728|NCT01751451|"~     In April 2011, the United States Food and Drug Administration (FDA) approved the oral drug~     abiraterone acetate (Zytiga ®) in combination with prednisone (a steroid) to treat patients~     with metastatic castration-resistant prostate cancer who have received prior docetaxel~     (chemotherapy). In December 2012, the FDA approved Zytiga ® in combination with prednisone to~     treat patients with metastatic castration-resistant prostate cancer who have not received~     prior chemotherapy. Degarelix (Firmagon ®), a testosterone lowering agent given as a monthly~     injection, is FDA approved for the treatment of patients with advanced prostate cancer. The~     purpose of this study is to evaluate abiraterone acetate and prednisone in combination with~     degarelix as a possible treatment for PSA recurrent prostate cancer as compared to~     abiraterone acetate alone and degarelix alone. This will be the first time these drugs will~     be used together.~   "
138729|NCT01751438|"~     The goal of this clinical research study is to learn if treatment with standard systemic~     therapy (androgen deprivation therapy or bilateral orchiectomy) in combination with surgery~     or radiation therapy is more effective at controlling prostate cancer than standard systemic~     therapy alone. The safety of this treatment combination will also be studied.~   "
138730|NCT01751425|"~     This is a 2 part study. The goal of the first part of this clinical research study is to find~     the highest tolerable dose of ruxolitinib that can be given with a TKI that you are already~     taking (such as gleevec, sprycel or nilotinib) as part of your standard of care treatment.~     The goal of the second part of this study is to learn if this drug combination can help to~     control CML. Although you have a good response to therapy, the disease is still detectable at~     low levels (this is called minimal residual disease). Researchers believe that eliminating~     all detectable evidence of disease may decrease the chances that the leukemia will ever come~     back. The safety of the drug combination will also be studied in both parts.~      Ruxolitinib is designed to block a protein called Jak2 that may help keep some leukemia cells~     alive even with TKI therapy. Blocking this protein may cause the cells to die.~      This is an investigational study. TKIs are approved for the treatment of CML and are given as~     part of your standard of care, even if you do not participate in this study. Ruxolitinib is~     FDA approved and commercially available for the treatment of patients with myelofibrosis. The~     combination of these drugs to treat CML is investigational.~      Up to 48 patients will take part in this study. All will be enrolled at MD Anderson.~   "
138731|NCT01751412|"~     This research study is a Pilot Study. Pilot studies are conducted to see if it is practical~     to do this type of research on a larger scale in the future. The pilot part of this study is~     to assess the possibility of using proton radiation to treat lymphomas. Proton radiation is~     used for many other types of malignancies, but its use for the treatment of lymphoma has been~     limited. The treatment is still being studied as research doctors are trying to find out more~     about its use in the treatment of different types of lymphoma. Proton beam radiation therapy~     is an FDA approved radiation delivery system.~      Patients are being asked to participate in this research study if they have lymphoma in the~     center of their chest, near their heart. Conventional radiation therapy with photons is used~     as standard treatment for many patients with lymphoma. In this research study investigators~     are looking at another type of radiation called proton radiation, which is known to spare~     surrounding tissue and organs from radiation. Proton radiation delivers radiation to the area~     requiring radiation but delivers no dose beyond the region requiring treatment. This may~     reduce side effects that patients would normally experience with conventional radiation~     therapy or other means of delivering proton radiation therapy.~      In this research study, investigators are evaluating the effectiveness of using proton~     radiation delivered to reduce side effects associated with radiation treatment.~   "
138732|NCT01751399|"~     The primary purpose of this study is to help answer the following research questions:~        -  To evaluate how much of the study drug (LY2605541) is in the blood of participants with~          varying degrees of liver impairment compared to those with normal liver function~        -  To assess the safety of LY2605541 and any side effects that might be associated with it~   "
138733|NCT01751386|"~     Background:~      - Baclofen is a drug used to control muscle stiffness in people with neurological diseases.~     Some studies suggest that baclofen may reduce alcohol craving and use. It helps to reduce~     anxiety in alcoholics, which in turn can help to reduce cravings. Researchers want to see if~     baclofen can be a safe and effective treatment for alcoholics who have high anxiety levels.~      Objectives:~      - To see if baclofen is safe and helpful for people who have alcoholism and high anxiety~     levels.~      Eligibility:~        -  Individuals between 21 and 65 years of age who have been diagnosed with alcoholism and~          anxiety issues.~        -  Participants must not be taking anti-anxiety medication.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Tests of alcohol dependency and anxiety levels will also be~          given.~        -  Participants will be divided into two groups. One group will take baclofen. The other~          group will have a placebo.~        -  About 1 week after the screening visit, participants will have a study visit. They will~          answer questions about their behavior and mood. They will then start to take either~          baclofen or a placebo. Participants will take the study drug three times a day, every~          day.~        -  After 1 week on the study drug, participants will have an overnight stay at the National~          Institutes of Health. They will have blood tests and answer questions about mood and~          behavior. They will also have tests that involve choosing to drink alcohol and answering~          more questions about cravings.~        -  Participants will stop taking their study drug over a 3-day period.~        -  A final follow-up visit will be required 1 week after the overnight study visit.~          Participants will receive information about other alcohol abuse treatment programs.~   "
138734|NCT01751373|"~     Within the first year after stroke, approximately 38% of stroke survivors experience an~     increased resistance to movement, also called spasticity. One type of treatment that is~     approved for stroke survivors in Canada that could reduce spasticity is the injection of~     Botulinum toxin (BTX) into the affected muscle. While BTX reduces spasticity, there is~     limited evidence to show that BTX administration leads to functional improvements. This may~     occur because the outcomes aren't sensitive enough to detect change, some people may have~     better responses to BTX, or because BTX hasn't been paired with the right exercises to~     improve function. The aims of this research are: i) to determine if there is a way of~     improving the markers that measure change in response to treatment; and ii) to identify the~     ideal type of exercise that should be paired with BTX to allow the drug to have it greatest~     effect.~      There are two primary research questions: a) What are the measures that will indicate whether~     a person with post-stroke spasticity will benefit from BTX therapy? It is hypothesized that~     EMG latency and amplitude, for those who best respond to BTX, will differ from those who~     demonstrate a weaker response to BTX; b)What is the ideal training approach for improving~     muscle function in stroke survivors receiving BTX injections? It is hypothesized that a~     training protocol that focuses on optimizing specific muscle activation patterns will~     demonstrate better outcomes than a training program designed to improve function.~   "
138735|NCT01751360|"~     To evaluate the efficacy and safety of treatment with SYR-472 in diabetic patients.~   "
138736|NCT01751347|"~     The use of local anesthetics has become an important aspect of pain management in surgical~     settings and is currently recommended in pain management guidelines.~      Elective outpatient hand surgeries, such as carpal tunnel or trigger finger release, cause~     minimum tissue disruption and are short in duration. As a result, these local anesthetic~     agents are a major component in post-operative pain control. The most commonly used local~     anesthetic agents are Lidocaine and Bupivacaine. Lidocaine acts faster (within 2-5 minutes of~     injection) and for this reason is often favored in outpatient setting for pre-incisional~     injection. However its effects only last up to 2 hours, without epinephrine, and 3 hours,~     with epinephrine. On the other hand, Bupivacaine, has a slower onset of action (about 5-10~     minutes after injection) but its effects last much longer, for about 4-8 hours. The delay in~     onset of action makes it a less popular option as a primary source of local anesthesia in~     outpatient hand surgery.~      Given the longer duration of anesthesia offered by Bupivacaine, the investigators believe~     that by giving it pre-operatively in elective outpatient hand surgeries will offer more~     effective post operative pain control compared to using Lidocaine only. There is limited~     published data confirming the effectiveness of use of pre-operative Bupivicaine in improved~     postoperative pain control and decreased consumption of narcotics. Therefore, the aim in this~     study is to compare the postoperative pain experienced by patients undergoing either elective~     carpal tunnel release or trigger finger release as well as their use of pain medications when~     the incision site is infiltrated preemptively with Lidocaine versus Bupivacaine.~      The investigators believe that adequate post surgical pain control is essential for patients'~     full functional recovery. Poorly controlled post surgical pain increases incidence of surgery~     related complications and thus increased health care costs. It can also reduce patients'~     mobility, delay their return to full function,. If poorly controlled, post surgical pain may~     progress to chronic pain and rarely complex regional pain syndromes may ensue.~   "
138737|NCT01751334|"~     The anatomic landmark for the anteroposterior (AP) axis of the proximal tibia and its~     variability was investigated in this study in order to determine whether a certain landmark~     could be employed as a reference axis for the proximal tibia after rotating platform mobile~     bearing (RP-MB) and fixed bearing (FB) total knee arthroplasties (TKAs).~   "
138738|NCT01751321|"~     Glucose Variability With DPP-4 Inhibition~   "
138739|NCT01751308|"~     Primary Objectives:~      Phase 1 Part:~      To determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) of~     cabazitaxel as a single agent in pediatric participants with recurrent or refractory solid~     tumors including tumors of the central nervous system.~      Phase 2 Part:~      To determine the objective response rate (complete and partial response) and the duration of~     response to cabazitaxel as a single agent in participants with recurrent or refractory high~     grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG).~      Secondary Objectives:~      Phase 1 Part:~      To characterize the safety and tolerability of cabazitaxel in participants with recurrent or~     refractory solid tumors including tumors of the central nervous system.~      To characterize the pharmacokinetic (PK) profile of cabazitaxel in participants with~     recurrent or refractory solid tumors including tumors of the central nervous system.~      To evaluate preliminary anti-tumor activity that may be associated with cabazitaxel in~     participants with recurrent or refractory solid tumors including tumors of the central~     nervous system.~      Phase 2 Part:~      To characterize the safety and tolerability of cabazitaxel in participants with recurrent or~     refractory HGG or DIPG.~      To estimate progression free survival in participants with recurrent or refractory HGG or~     DIPG.~      To estimate overall survival in participants with recurrent or refractory HGG or DIPG.~      To characterize the plasma PK profile of cabazitaxel in participants with recurrent or~     refractory HGG or DIPG.~   "
138740|NCT01751295|"~     The purpose of this study is to evaluate the effect of statin on the coronary~     microcirculation dysfunction measured after percutaneous coronary intervention.~   "
138741|NCT01751282|"~     The purpose of this study is to determine the effectiveness of Autologous Bone Marrow-Derived~     Mesenchymal Stem Cells (MSCs) in the treatment of non-healing wounds.~   "
138742|NCT01751269|"~     RPX7009 (beta-lactamase inhibitor) is being studies in combination with a carbapenem biapenem~     to treat bacterial infections, including those due to multi-drug resistant bacteria.~   "
138743|NCT01751256|"~     The purpose of this study is to determine wether wound infiltration brings additional~     analgesia effect after cesarean section with optimal standard postoperative analgesia~   "
138744|NCT01751243|"~     Therapeutic exploratory study to evaluate safety, open, nonrandomized, multicentre,~     prospective, of cohort of patients who will receive different doses of allo-depleted~     lymphocytes .~      This project joins in this pioneering worldwide initiative with its own technology based on~     the use of proteasome inhibitors in vitro, which advantages are, over other methods~     described, the continuing viability of regulatory T cells and the use of a product to~     generate allo-depletion that, contrary to those reported by other research groups, it does~     not pose problems from the point of view of its use or toxicity as we employ a drug widely~     used clinically by intravenous administration.~   "
138745|NCT01751230|"~     The purpose of this study is to help women lose the weight they gained during their pregnancy~     using a SmartPhone app the investigators have developed called E-Moms. The investigators~     hypothesize that the moms given the app to use during the study will lose more weight than~     the moms who do not use the app.~   "
138746|NCT01751217|"~     The current proposal is a randomized clinical trial testing the efficacy of Functional Family~     Therapy (FFT) administered by video teleconference (FFT-V) in the homes of substance abusing~     adolescents. In the proposed investigation, FFT-V will be compared with FFT administered~     face-to-face in the family home as well as to a services-as-usual (SAU) condition. The~     overarching objective of the study is to examine the degree to which an empirically based~     model of substance abuse treatment such as FFT can be effectively administered via video~     teleconferencing to adolescents and families living in rural and remote areas who would be~     otherwise unlikely to access treatment. The specific aims of the proposed study are to (1)~     evaluate the efficacy of FFT-V compared to FFT and SAU in reducing adolescent drug use, HIV~     risk behavior, delinquency, and recidivism, (2) evaluate the efficacy of FFT-V compared to~     FFT in establishing functional levels of therapeutic alliance formation, treatment~     attendance, retention, and satisfaction with treatment, (3) evaluate the efficacy of FFT-V~     compared to FFT and SAU in impacting core mechanisms of change in adolescent behavior~     including improved levels of family functioning and adolescent association with substance~     using peers, and (4) conduct a preliminary cost-effectiveness analysis to derive initial~     estimates of the relative costs of each treatment modality per outcome unit.~   "
138747|NCT01751204|"~     The purpose of this study is to evaluate the absorbability of calcium tablet and calcium ion~     water.~   "
138785|NCT01750710|"~     This exploratory cross-sectional study proposes, firstly, to objectify in a population of~     Charcot-Marie-Tooth disease type 1A (CMT 1A)if there is a correlation between the recording~     of electrical parameters and upper limb muscle strength of the thigh and in a second step, to~     seek a relationship between the measured parameters.~   "
138748|NCT01751191|"~     Background: In patients with cirrhosis on secondary prevention of variceal rebleeding with~     non-selective beta-blockers (NSBBs), the risk of rebleeding and death is markedly higher in~     those failing to achieve a good hemodynamic response (HVPG reduction ≥20% of baseline values~     or ≤12mmHg). However a substantial proportion of non-responders will never rebleed, thus~     appearing protected by NSBBs although non-detected by HVPG response. This low sensitivity~     hampers risk stratification and diminishes the cost-effectiveness of assessing the~     hemodynamic response to NSBBs. This is particularly relevant in prevention of rebleeding~     since in this scenario the risk of rebleeding and of other portal hypertension related~     complications is very high, which calls for early institution of effective therapy.~      Baseline HVPG bears prognostic significance with regards to risk of developing varices,~     decompensation, hepatocellular carcinoma and death1,2,7,8,18-27. However, no studies have~     investigated whether adding data from baseline HVPG may improve the sensitivity of the~     criteria defining a good or poor hemodynamic response.~      Hypothesis: Adding data from baseline HVPG may improve the sensitivity of the criteria~     defining a good or poor hemodynamic response.~      Objective: Exploring the prognostic value of basal HVPG that better discriminate those~     non-responders who do not re-bleed under prophylactic treatment with NSBBs.~      Methods: Observational cohort study. Training set: patients from two longitudinal studies~     conducted at the Hepatic Hemodynamic laboratory of the Hospital Clínic of Barcelona to assess~     the prognostic value of HVPG changes during continuous therapy with NSBBs for preventing~     variceal rebleeding. Validation set for chronic hemodynamic response: patients from two~     longitudinal studies conducted at the Hepatic Hemodynamic laboratory of the Hospital de Sant~     Pau of Barcelona to assess the prognostic value of HVPG changes during continuous therapy~     with NSBBs for preventing variceal rebleeding; a third cohort composed of patients undergoing~     acute hemodynamic response to intravenous propranolol will be studied.~      All patients received a preplanned follow-up in the outpatient clinic at 1, 3, and 6 months,~     and every 6 months thereafter in the original studies.~      End-point: bleeding from portal hypertensive sources (esophago-gastric varices or portal~     hypertensive gastropathy) (defined according to Baveno criteria 32), death or liver~     transplantation.~      Ethical aspects: All patients have given their written informed consent to use their data in~     the original studies.~   "
138749|NCT01751178|"~     The aim of this study is to compare subject gingival health after 6 weeks of twice daily use~     of a non-alcohol or alcohol containing mouthrinse and brushing compared to brushing only.~   "
138750|NCT01751165|"~     The purpose of this study is to assess the safety and immunogenicity of the GSK Biologicals'~     HZ vaccine 1437173A administered on either a 0,2-; 0,6- or 0,12-month schedule in adults aged~     50 years or above, as the immunogenicity of the HZ vaccine administered at intervals longer~     than two months is not known.~   "
138751|NCT01751152|"~     This trial is conducted in Europe and the United States of America (USA). The aim of the~     trial is to assess clinical efficacy and safety of NNC0114-0006 in subjects with active~     Crohn's disease.~   "
138752|NCT01751139|"~     The purpose of this study is to estimate the incidence of dengue infection in children and~     adults in geographically distinct locations of Brazil.~   "
138753|NCT01751126|"~     The objective of this study is to compare the efficacy of two different dosing regimen of~     NOVA22007 (1mg/ml ciclosporin/cyclosporine) eye drops, emulsion versus placebo (vehicle of~     the formulation) administered four times a day in patients with severe vernal~     keratoconjunctivitis after 4 months of treatment.~   "
138754|NCT01751113|"~     The purpose of this study is to evaluate the effects on lung function of a combination of~     ADOAIR 50/250mcg twice daily plus tiotropium bromide 18mcg once daily compared with the~     individual treatments (tiotropium bromide 18mcg once daily alone and ADOAIR 50/250mcg twice~     daily alone) in Japanese subjects with COPD. The study will utilize a three-way cross-over~     design with a 2-week wash-out period between each 4-week consecutive treatment period. The~     aim is to support the rationale for triple combination therapy by demonstrating that~     treatment with both ADOAIR and tiotropium can potentially produce improved, clinically~     relevant effects compared with either treatment alone.~      This study will utilize a range of lung function measures in order to fully assess the~     benefits of triple therapy. The primary endpoint will be based on airways conductance~     measured using plethysmography (sGaw measured over 4hours post dose (AUC 0-4hr) on Day 28).~     Secondary endpoints will include lung function measures based on plethysmography and~     spirometry. The lung function measures will be supported by measurement of the use of relief~     salbutamol .~   "
138755|NCT01751100|"~     The purpose of this study is to see if offering a general health screening tailored towards~     high-risk groups (African immigrants, injection drug users (IDUs), and minority men who have~     sex with men (MSM)) will increase human immunodeficiency virus (HIV) testing, counseling, and~     linkage acceptance rates in community pharmacies.~   "
138756|NCT01751087|"~     The purpose of this research study is to compare three different ways of opening a woman's~     cervix before her second-trimester surgical abortion.~        -  Osmotic dilators: small rods that, when inserted into the cervix, gently expand to open~          the cervix~        -  Osmotic dilators plus mifepristone, a medicine that is swallowed~        -  Osmotic dilators plus misoprostol, a medicine that is placed between the cheek and gum~      Hypotheses:~        -  adding buccal misoprostol 3 hours preoperatively will significantly improve dilation~          compared to laminaria alone, making procedures faster, easier and safer.~        -  adding oral mifepristone at the time of laminaria placement will confer a similar~          benefit.~        -  the efficacy of adjunctive misoprostol and mifepristone will be influenced by~          gestational age, with women later in gestation having increased efficacy from these~          agents.~        -  significantly more patients who receive adjunctive misoprostol or mifepristone will have~          adequate initial dilation, fewer will require manual dilation or additional cervical~          preparation and there will be fewer complications in these arms, although complication~          rates will be low and we will only be able to detect relatively large differences.~        -  patients will prefer to have the procedure done as quickly as possible with as little~          discomfort as possible, that cervical ripening with adjunctive misoprostol will be~          associated with more cramping than osmotic dilators alone and that mifepristone will be~          well tolerated and may not cause more cramping or other side effects than osmotic~          dilators alone.~   "
138757|NCT01751074|"~     The potential for a drug interaction between Darapladib and Rosuvastatin is felt to be low~     and it would be helpful to quantify this risk in man in order to guide prescribing~     physicians. The primary aims of this study are to estimate the potential effects of repeat~     doses of Darapladib on the PK of Rosuvastatin as well as evaluating safety and tolerability.~     Two part approaches are planned for this study. Part A of the study will examine the effects~     of repeat doses Darapladib on the PK of Rosuvastatin in healthy volunteers of Caucasian~     descent. Based on whether a significant increase in Rosuvastatin exposure is observed in~     Caucasians in Part A, a decision will be made regarding whether to proceed with a conditional~     Part B to examine this effect in healthy volunteers of Far-East Asian descent.~      In both parts, subjects will receive Rosuvastatin 10 milligrams (mg) once daily (QD) for 1~     day during the first treatment period (Treatment Period 1), followed by a 4 day PK sampling~     period/wash-out. Subjects will then receive darapladib 160 mg QD for the next 10 days with~     24-hour PK sampling on the last day (Day 14 of the study). Immediately following this, all~     subjects will then receive the combination of Darapladib 160 mg and Rosuvastatin 10 mg for 1~     day and continued Darapladib dosing of 160 mg QD for additional 3 days (Treatment Period 2)~     while blood samples are collected to assess Rosuvastatin PK. Plasma samples collected on Day~     15 will be analyzed for both Rosuvastatin and Darapladib concentrations.~      Subjects will be required to return to the unit approximately 10 to 14 days following the~     last dose of study medication for a clinic visit for assessments and then will return again~     at 35 ±7 days following the last dose for the final follow-up visit of the study. The~     duration of each subject's participation in the study from screening to follow-up will be~     approximately three months.~      Approximately 18 evaluable subjects will be enrolled in Part A and another 18 subjects will~     be enrolled in Part B (if conducted) to complete dosing and all assessments.~   "
138759|NCT01751048|"~     Investigational products: LEISH-F3 (recombinant protein antigen) + GLA-SE (adjuvant)~     leishmaniasis vaccine and LEISH-F3 (recombinant protein antigen) + MPL-SE (adjuvant)~     leishmaniasis vaccine. Stage of development: Phase 1 clinical development. Healthy adult~     subjects, 18 to 49 will be recruited through a U.S. site. Primary objective: To evaluate the~     safety and tolerability of the LEISH-F3 + GLA-SE vaccine and the LEISH-F3 + MPL-SE vaccine~     following intramuscular (IM) administration of 20 µg of LEISH-F3 together with 2 or 5 µg of~     GLA-SE or 10 µg of MPL-SE on Days 0, 28, and 168. Secondary objective: To assess the~     immunogenicity of LEISH-F3 formulated with GLA-SE, MPL-SE, or SE by evaluating IgG antibody~     responses to LEISH-F3 at Days 0, 28, 56, 168, 196, and 365, and T cell responses to LEISH-F3~     at Days 0, 14, 42, 168, 182, and 365. Each subject's duration of participation will be about~     18 months.~   "
138760|NCT01751035|"~     Adolescents receiving RRFT and their caregivers will report significantly fewer substance use~     problems (quantity of use, frequency of use, and abuse symptoms) during treatment and~     follow-up than control adolescents who receive Treatment as Usual (TAU). Adolescents~     receiving RRFT and their caregivers will report improvement in empirically-demonstrated risk~     and protective factors for substance use and abuse at the individual level (e.g., coping) and~     at each level of an adolescent's ecology (e.g., increased number of positive family~     activities, reduced family conflict, reduced number of peers who use drugs, improved school~     attendance, increased involvement in pro-social community activities) during treatment and~     follow-up than control adolescents who receive TAU. Adolescents receiving RRFT will~     experience less PTSD symptoms (per youth and caregiver reports) during treatment and~     follow-up than control adolescents who receive TAU. Adolescents receiving RRFT will report~     engaging in fewer risky sexual behaviors (e.g., increased condom use, fewer partners) during~     treatment and follow-up than control adolescents who receive TAU. Changes during treatment in~     family relations (familial cohesiveness and conflict, satisfaction with caregiver-youth~     relationship) and parenting practices (monitoring) will mediate changes in substance use.~     Changes during treatment in emotional reactivity will mediate changes in PTSD symptoms.~   "
138761|NCT01751022|"~     The purpose of the study is to evaluate the safety and efficacy of the Medtronic Attain~     Performa Quadripolar Leads (Model 4298, 4398, and 4598) during and post the implant~     procedure. This study will also assess the interactions of the Attain Performa leads with the~     entire Medtronic CRT-D system.~   "
138762|NCT01751009|"~     This study tried to prove that children given food supplements containing vitamin A would~     have better liver vitamin A stores than children given food supplements without vitamin A~     over a 5 month period.~   "
138763|NCT01750996|"~     The goal of the Strongest Families Finland Canada project is to help parents develop skills~     to strengthen their families and reduce disruptive behavior in their 4 year old children.~   "
138764|NCT01750983|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of Yervoy® (ipilimumab) with Revlimid® (lenalidomide) that can be given to~     patients with advanced cancer. The safety of these drugs will also be studied.~      Ipilimumab is designed to increase the immune system's ability to fight cancer.~      Lenalidomide is designed to change the body's immune system. It may also interfere with the~     development of tiny blood vessels that help support tumor growth. This may decrease the~     growth of cancer cells.~   "
138765|NCT01750970|"~     To confirm the benefit of endoscopic resection under fluorescence and blue light of high~     grade non-muscle invasive bladder tumor, and verifying if the second endoscopic resection~     recommended nowadays can be deleted.~   "
138766|NCT01750957|"~     This randomized, double-blind, placebo-controlled, parallel-arm study will evaluate the~     safety and exploratory efficacy and pharmacokinetics of RO4917523 in pediatric patients with~     fragile X syndrome. Patients will be randomized to receive one of 2 dose levels of RO4917523~     or placebo orally daily for 12 weeks.~   "
138767|NCT01750944|"~     The main objective of this study is to evaluate the concordance of the variation in systolic~     pressure indices measured at the toe and ankle after a walking test in healthy volunteers.~   "
138768|NCT01750931|"~     It is a randomized, balanced, open label, crossover, two period, two treatment, two sequence,~     single dose, oral bioequivalence study of Meloxicam GSK 15 mg tablets manufactured by~     Savipharm J.S.Cc, Vietnam and Mobic® 15 mg tablets of Boehringer Ingelheim Pharma GmbH & Co.~     KG Binger Str.173, 5521 Ingelheim am Rhein, Germany, in healthy, adult, human male subjects~     under fed condition. It is a pivotal study to demonstrate the bioequivalence of Meloxicam GSK~     15 mg tablets manufactured by Savipharm J.S.C, Vietnam and Mobic® 15 mg tablets of Boehringer~     Ingelheim Pharma GmbH & Co.KG Binger Str.173, 5521 Ingelheim am Rhein, Germany, in healthy~     adult human male subjects under fed condition.~      This study will enroll 28 healthy adult human male subjects~   "
138769|NCT01750918|"~     This is an open-label, four-part Phase I/II study to investigate the safety,~     pharmacokinetics, pharmacodynamics and clinical activity of trametinib (GSK1120212) and~     dabrafenib (GSK2118436) when administered in combination with the anti-EGFR antibody~     panitumumab in subjects with BRAF-mutation V600E positive colorectal cancer (CRC) and in~     subjects with CRC with secondary resistance to prior anti-EGFR therapy. Part 1 of the study~     will consist of dose-escalation cohorts, following a 3 + 3 enrollment scheme. Part 2 of the~     study will consist of expansion cohorts to investigate safety and clinical activity of~     dabrafenib in combination with panitumumab and trametinib plus dabrafenib in combination with~     panitumumab. Part 3 of the study will be a randomized Phase II study comparing dosing with~     dabrafenib in combination with panitumumab and trametinib plus dabrafenib in combination with~     panitumumab as compared to the chemotherapy comparator (a regimen of leucovorin calcium,~     fluorouracil, oxaliplatin (FOLFOX), leucovorin calcium, fluorouracil, irinotecan~     hydrochloride (FOLFIRI) or irinotecan with or without panitumumab or bevacizumab). Subjects~     will be assigned to treatment groups in a randomized fashion to compare safety and clinical~     activity. Part 4 of the study will investigate the trametinib/panitumumab combination,~     including dose escalation and subsequent cohort expansion in two patient populations: 1)~     BRAF-mutation V600E positive CRC and 2) subjects with CRC who developed secondary resistance~     to prior anti-EGFR therapy. The objective of Part 4 is to identify the recommended Phase 2~     dose/regimen for trametinib dosed in combination with panitumumab in dose escalation and to~     identify an initial signal of clinical activity in expansion cohorts.~   "
138772|NCT01750879|"~     The unifying objective of this project is to determine whether peanut oral immunotherapy (PN~     OIT) induced clinical tolerance in the context of food allergy is significantly associated~     with the expansion of a specific regulatory T cell subset (CD45RA- CD25++ FoxP3++) that is~     thought to be inducible in the gut-associated lymphoid compartment and associated with~     immunological tolerance.~      The hypothesis of the study is that the induction of Treg cells will be associated with~     clinical tolerance.~      The investigators will measure the change from baseline of induced Treg cells as a frequency~     of total CD4 T cells during active treatment and compare that between participants who~     achieve significant clinical tolerance (Tolerance and Partial Tolerance Groups as defined~     below) and those who do not (Treatment Failure Group).~   "
138773|NCT01750866|"~     Cabazitaxel is already approved by the Food and Drug Administration (FDA) for use in patients~     with advanced prostrate cancer, following docetaxel therapy. The purpose of this study is to~     better understand the response and toxicity of cabazitaxel of elderly men (age 75 years and~     older) with advanced prostate cancer who have progressed during or after treatment with~     docetaxel. All patients on this study will receive cabazitaxel by intravenous (through a~     vein) infusion plus prednisone by mouth twice daily, and following the chemotherapy~     infusions, an injection of a granulocyte colony-stimulating factor (G-CSF). G-CSF will help~     the body produce more white blood cells, which should help decrease the risk of getting an~     infection while being treated with cabazitaxel.~   "
138774|NCT01750853|"~     The purpose of this study is to investigate the safety and tolerability of LY3045697 after a~     single dose, and to determine how long LY3045697 remains in the body. Two cohorts (groups) of~     9 participants each will participate in 3 dosing periods. These participants will receive~     placebo in one period only. A third cohort of 9 will participate in 2 dosing periods and~     participants will receive either 2 dose levels of LY3045697 or 1 dose level of LY3045697 and~     placebo by the end of both periods.~   "
138775|NCT01750840|"~     The purpose of this clinical registry is to capture data on an ongoing basis from a~     population of patients who will use Biomet's BHS, OrthoPak and SpinalPak devices.~   "
138776|NCT01750827|"~     This will be an open-label, single dose, single period study. Approximately 14 subjects will~     receive one dose of 250 mg of non-enteric coated SB-659032 following a low-fat breakfast.~     This study will evaluate whether SB-659032 has an effect on platelet function as determined~     by platelet aggregation tests using the agonists ADP and collagen. Blood samples for PK~     analysis and measurement of Lp-PLA2 activity will also be collected~   "
138777|NCT01750814|"~     The primary objective is to demonstrate the immunological non-inferiority between GC3102C and~     GC FLU inj. influenza vaccines by assessing geometric mean titers(GMTs) in healthy adults~   "
138778|NCT01750801|"~     Characterization of green propolis and development of mouthwash containing propolis to~     control plaque and gingivitis. A Phase I.~   "
138779|NCT01750788|"~     This is an international observational study in patients with non-valvular atrial~     fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent~     stroke or non-central nervous system systemic embolism.~   "
138780|NCT01750775|"~     The purpose of this study is to assess the effects of Chinese medicine Shansong Yangxin~     capsule for sinus bradycardia complicated with ventricular premature beats.~   "
138781|NCT01750762|"~     This research is a Phase I clinical trial. Phase I clinical trials test the safety of an~     investigational drug. Phase I studies also try to define the appropriate dose of the~     investigational drug to use for further studies. Investigational means that the drug is~     still being studied and that research doctors are trying to find out more about it. It also~     means that the FDA has not approved lenalidomide for your type of cancer.~      Lenalidomide is a drug that alters the immune system and it may also interfere with the~     development of tiny blood vessels that help support tumor growth. Therefore, this study will~     determine the effect of lenalidomide on the growth of cancer cells. Lenalidomide is approved~     by the FDA for the treatment of specific types of myelodysplastic syndrome (MDS) and in~     combination with dexamethasone for patients with multiple myeloma (MM) who have received at~     least 1 prior therapy. MDS and MM are cancers of the blood. It is currently being tested in a~     variety of cancer conditions. In this case it is considered experimental.~      There are some participants with multiple myeloma or lymphoma who have had very long~     remissions after a bone marrow/stem cell transplantation from another person. This is~     believed to be the effect of the donor's immune system reaction against the recipient's~     multiple myeloma cells. It is hoped that due to lenalidomide altering the immune system, it~     might be able to potentiate that reaction. This study is being done to determine if the use~     of lenalidomide is safe in transplant participants and if it can facilitate an immune~     reaction resulting in regression of the myeloma or lymphoma.~      During this study you will be evaluated for side effects from the treatment with lenalidomide~     (including graft versus host disease) and for response of the myeloma to the treatment. There~     will be two groups of participants in the study. The first group will be treated at a~     relatively low dose of lenalidomide. If this is found to be safe then the second group will~     be treated at a higher dose~   "
138782|NCT01750749|"~     Chronic venous leg ulcers (CVU) represent a medical problem associated with significant~     morbidity, increased work absenteeism and earlier retirement as a consequence of disability.~     This strongly affects the patient's quality of life and has a significant economic impact on~     healthcare systems.~      Reports of studies with animal models show that treatment with bone marrow-derived stem cells~     has a beneficial effect in healing chronic skin wounds.~      The purpose of this pilot study is to determine the safety and feasibility of cell therapy~     with bone marrow derived cells (BMDC) as a complementary healing therapy in chronic venous~     leg ulcers, and in addition to evaluate its effectiveness. The knowledge gained in the pilot~     study will be used to refine the clinical protocol procedures of a subsequent randomized~     study.~      Patients with venous legs ulcers meeting eligibility criteria and providing appropriate~     written informed consent will be enrolled for study participation. Enrolled patients will~     receive Autologous BMDC implantation at de venous ulcer in conjunction with standard of care~     (SOC) treatment.~      During follow up, adverse events will be assessed by ulcer clinical examination.~     Effectiveness of the experimental treatment will be assessed by evaluating ulcer healing~     (reduction of the ulcer area) and pain reduction over a six-month period.~   "
138783|NCT01750736|"~     Manual therapy and exercise have shown to be beneficial for people with neck pain, however it~     is not clear how outcomes following a general exercise program compare to specific exercises~     intended to augment a specific manual/hands-on intervention. This study will compare outcomes~     following manual therapy and a specific exercise program with manual therapy and a general~     exercise program.~   "
138784|NCT01750723|"~     In this study the investigators will research the hypothesis that the drug Acetazolamide~     induce headache and dilation of cerebral arteries and increase the cerebral blood flow in the~     areas of the brain supplied by these arteries.~   "
138788|NCT01750671|"~     It is established that the surviving patients after a stay in the ICU are characterized by~     frequent malnutrition and morbidity and mortality. The main goal of this work is to study the~     relationship between nutritional statuses during ICU hospitalization, whatever its~     determinants, and quality of life, morbidity and mortality at one year.~      The hypothesis of the study is that the presence of under nutrition is responsible for a 10%~     increase in crude mortality at one year (which would be respectively 30% for malnourished~     patients and 20% for non-malnourished patients).~   "
138789|NCT01750658|"~     ECOS is a cross-sectional, observational, longitudinal, multicenter study enrolling 100-200~     patients during a COPD exacerbation.~   "
138790|NCT01750645|"~     Overactive bladder is defined as a syndrome composed of urgency, increased urinary frequency,~     and sometimes urinary incontinence; its etiology may be characterized as neurogenic or~     non-neurogenic (i.e., idiopathic). This illness has a great impact in quality of life and one~     of the available treatments is the injection of Botulinum Toxin. This study aims to review~     the efficacy and safety of type-A Botulinum Toxin in the management of Idiopathic Overactive~     Bladder. A systematic search was performed in MEDLINE, EMBASE, CENTRAL and LILACS, and the~     controlled randomized clinical trials were chosen to review with the CONSORT criteria by~     independent reviewers. Outcomes analyzed were the efficacy of the intervention for relieving~     the symptoms (urgency, frequency and urgency incontinence), adverse events to treatment,~     change in quality of life and urodynamic measures.~   "
138791|NCT01750632|"~     Men with Klinefelter syndrome undergo unilateral subcapsular ochiectomy, and the removed~     testicular tissue is examined for presence of sperm and cryopreserved in small pieces for~     fertility treatment and scientific purposes. Prior to operation blood samples are frozen in a~     biobank.~   "
138792|NCT01750619|"~     To evaluate clinical outcome for patients receiving treatment of suspected premalignant and~     malignant gastrointestinal lesions at Interventional Endoscopy Services. The primary outcome~     is curative endoscopic resection. Secondary outcomes include resection technique utilized,~     rates of en bloc resection and adverse event rates, including infection, bleeding,~     perforation and death, and one-year survival rates.~   "
138793|NCT01750606|"~     Retrospective study to comply with FDA's post-market surveillance order. The purpose of the~     study is to contact patients who have received a Biomet metal-on-metal product as their~     primary total hip arthroplasty device. Patients who have not been revised prior to contact~     will be asked to submit to a blood draw, clinical exam and MRI.~   "
138794|NCT01750593|"~     Thyroid nodules are common problems and although > 95% are stated to be benign, they may~     cause some problems like hyperthyroidism, compression symptoms, and cosmesis associated with~     their function, size and localization. Especially for these nodules, patients undergo surgery~     and face up with the problems associated with surgical complications although they are not~     cancer. In some studies, radiofrequency ablation previously used for intrabdominal tumors~     like hepatic metastasis...,was stated to be efficient in the treatment of benign thyroid~     nodules and in some recurrent thyroid cancer cases. Therefore, the investigators decided to~     use this method in our patients having nodules like previously mentioned and see the efficacy~     and safety of the technique.~   "
138795|NCT01750580|"~     To assess the safety and tolerability, characterize the dose-limiting toxicities (DLTs), and~     identify the maximally tolerated dose (MTD) of BMS-986015 given in combination with~     ipilimumab in subjects with select advanced (metastatic and/or unresectable) solid tumors.~   "
138796|NCT01750567|"~     Metformin is an antidiabetic drug which is an inexpensive and generally well tolerated~     medication. More recently metformin has been shown to act against carcinomas by two~     mechanisms: 1) an indirect, insulin‐dependent mechanism which sensitizes tissues to insulin,~     inhibits hepatic gluconeogenesis, and stimulates uptake of glucose in muscle, thereby~     reducing fasting blood glucose and circulating levels of insulin, lowering the pro survival~     activity of the insulin/INSR axis, and 2) a direct, insulin‐independent mechanism which~     activates the AMP‐activated protein kinase (AMPK) pathway and leads to inhibition of the mTOR~     pathway. Given the investigators preliminary published data on insulin and mTOR inhibition[1]~     metformin is an attractive candidate for a pilot clinical trial in CLL patients.~   "
138797|NCT01750554|"~     The investigators are proposing to continue investigation to improve the accuracy of the SpHb~     (continuous hemoglobin monitoring device) by administering an intermediate acting digital~     nerve block in the finger connected to the SpHb, specifically bupivacaine 0.25% in patients~     undergoing spine surgery. Bupivacaine is FDA approved and in routine use.~   "
138798|NCT01750541|"~     The aim of this study is to compare the efficacy of haloperidol and valproate in management~     of people with agitation in emergency department~   "
138799|NCT01750528|"~     1. Our hypotheses on the relationship between periodontitis and AS are as follows;~             -  The prevalence of periodontitis is higher in AS patients group than that of non-AS~               control group~             -  Anti-TNF-α therapy would favorably affect the disease course of periodontitis.~        2. Based on our hypotheses, the specific objectives of the present proposal are as follows;~             -  The primary objective is to compare the prevalence rate of periodontitis between AS~               patient group and non-AS group.~             -  The secondary objectives will be:~                  -  To observe the carriage rate of P. gingivalis in AS and non-AS groups~                  -  To identify clinical parameters associated with the severity of periodontitis~                    in AS group.~                  -  To compare the progression of periodontitis at weeks 12 and 24 between AS and~                    non-AS groups or between AS patients with and without anti-TNF-α treatment~   "
138811|NCT01750372|"~     Standardized outcome measures can be used to document patient health outcomes and improve~     treatment of those requiring prosthetic and orthotic (O&P) services. Though numerous~     instruments have been developed, existing measures of O&P outcomes have serious shortcomings~     including limited evidence that the scores are responsive to clinical changes.~      The investigators are developing the Prosthetic Limb Users Survey-Mobility (PLUS-M) using~     modern measurement methods to be a brief, precise and flexible measure of mobility for~     persons with lower limb amputation (LLA). The investigators propose the following objectives~     to achieve this goal.~      Key objective 1: develop a measure (item bank) for measuring mobility in persons with lower~     limb loss~      Key objective 2: study health profiles of lower limb prosthetic users~      Key objective 3: validate the measure in a longitudinal study of people receiving replacement~     prosthetic limbs~      Key objective 4: study longitudinal health patterns of persons with lower limb amputation~   "
138800|NCT01750515|"~     Objective: to study the effect of Acupuncture on liver cirrhosis, SVR and health related~     quality of life in HCV patients receiving standard treatment (Peg Interferon+ Ribavirin).~      Methods: 60 HCV patients receiving standard treatment (Peg Interferon+ Ribavirin) will~     undergo Serologic screening for hepatitis C virus (Anti-HCV EIAs and/or recombinant~     immunoblot assay) plus Transient Ultrasound Elastography (FibroScan) to achieve baseline~     characteristics(17,18,19). Patients will be randomized into intervention and control groups,~     30 patients each.In the Intervention group each patient will receive an acupuncture treatment~     once a week for 12 consecutive weeks(Max 12, Min 8 treatments). Treatment protocol will be~     individualized for each patient according to TCM diagnosis. This treatment protocol is~     acceptable and has been published(20,21,22).In the control group patients will receive~     standard treatment alone, with no other intervention.~      Data collection: after 12 weeks patients will again undergo Serologic screening for hepatitis~     C virus (Anti-HCV EIAs and/or recombinant immunoblot assay) plus Transient Ultrasound~     Elastography (FibroScan) in order to detect changes from baseline and group differences.~      Inclusion criteria: adult patients with a confirmed HCV infection~      Exclusion criteria:~      Under 18 years Can not receive standard Peg interferon+ ribavirin treatment for any reason~     Psychiatric diagnosis Anaemia of hematologic origin Diabetic patient with uncontrolled~     diabetes Congestive heart failure, arrhythmia Hepatocellular carcinoma HIV infection~     Hepatitis B infection Auto immune liver disease or alcoholic liver disease Study duration: 1~     year Study Location: Ziv medical center, division of liver disease, Israel~   "
138801|NCT01750502|"~     Macrophage migration inhibitory factor (MIF) is a pleiotropic cytokine that promote the~     inflammatory response.In animal studies, it has been found that MIF is released in the~     ischaemic heart, promoting glucose uptake and protecting the heart from ischaemia-reperfusion~     injury.The MIF concentration, influenced by age and myocardial ischemia, have different~     impact on myocardial functional recovery after ischemia.Therefore, the purpose of this~     experiment is to study the clinical significance of MIF in patients with coronary heart~     disease.~   "
138802|NCT01750489|"~     The objective of the project is to better understand the causes of exercise limitation,~     dyspnea and neurohumoral activation in patients with COPD. In particular, the investigators~     aim to explore the mutual interaction of neurohumoral activation and exercise limitation~     thereby focussing on differential effects of the peripheral muscle and the diaphragm.~      Eventually the findings might influence treatment modalities. If sympathetic activation~     contributes to exercise limitation then drugs influencing the autonomic nervous system would~     be a reasonable therapeutic concept. If a reduction of sympathetic activity due to an~     alteration of the ergoreflex can be achieved by non-invasive ventilation this would help to~     improve dyspnea and exercise capacity.~   "
138803|NCT01750476|"~     The investigators are conducting a research study to understand how cells responsible for~     fighting infection (immune cells) are affected by hormonal contraceptive use. The~     investigators hypothesize that progestin-containing hormonal contraceptives (i.e.,~     Depo-Provera) inhibit host response to infection. To test this hypothesis, the investigators~     will collect blood and genital tract samples from women before and after their initiation of~     a hormonal contraceptive (either birth control pills, Depo-Provera, or Mirena).~   "
138804|NCT01750463|"~     This is a prospective study to determine the accuracy of the Masimo Pronto Non-Invasive~     Hemoglobin Monitor and associated Rainbow® probes in the detection of hemoglobin~     concentration in critically ill children.~   "
138805|NCT01750450|"~     The investigators will generate pressure-flow loops and pressure-volume loops from aortic and~     left ventricular pressure waveforms and Doppler (desc. aorta) flow waveforms and compare left~     ventricular to arterial pressure-flow and pressure-volume loops as well as to cardiac power~     from the USCOM 1A device. The goal of this study is to test the hypothesis that non-invasive~     estimates of cardiac pressure-volume work (derived from ultrasound-based measurements)~     correlate with invasive estimates.~   "
138806|NCT01750437|"~     Randomized, double-blind, active-controlled, multi-center phase 2 clinical trial to~     investigate the safety, tolerability and efficacy of YH1885L in patients with non-erosive~     reflux disease(NERD)~   "
138807|NCT01750424|"~     The purpose of this study is to assess scar-formation and wound healing following the use of~     autologous fat grafting in facial reconstruction patients. Patients who have undergone facial~     reconstruction in the last 3 months will be randomized into two groups, one receiving fat~     grafting and one not receiving any intervention. These patients will continue to follow-up in~     our clinic for one year, with 3-D images taken at each follow-up visit to assess scar~     formation and wound healing. Assessment of the scar will be undertaken by both healthcare~     personnel as well as general lay public. We hypothesize that patients undergoing fat grafting~     to the wound site will achieve a more aesthetically appealing result, with less scarring and~     improved wound healing as judged by both the general public and healthcare professionals.~   "
138808|NCT01750411|"~     The mission of SARP is to improve the understanding of severe asthma through the integrated~     study of the effect of genetics on the clinical and biological features of asthma and to~     investigate how these change over time. The ultimate goal of these efforts is to promote~     better treatments for severe asthma.~   "
138809|NCT01750398|"~     The purpose of this study is to determine the safety and clinical effects of alternating~     androgen deprivation therapy with testosterone therapy in men with recurrent prostate cancer~     as first line hormonal therapy, to assess the effect of alternating therapy on quality of~     life and metabolic changes associated with androgen-deprivation therapy.~   "
138810|NCT01750385|"~     Peroral Endoscopic Myotomy (POEM) is a novel, promising endoscopic technique for achalasia~     because it is safer and more effective than traditional Heller's myotomy. However, the issue~     of antibiotic prophylaxis in POEM has evoked considerable controversy recently. Therefore, we~     conduct this study to elucidate the status of POEM-related bacteremia and procalcitonin~     levels in order to preliminary observe whether antibiotic prophylaxis is needed.~   "
138826|NCT01750177|"~     The purpose is to investigate the effect of sedentary screen time activities on food intake~     and subjective appetite in 9- to 14-year old normal weight and overweight/obese girls. The~     investigators hypothesize that pre-meal exposure to screen time activities for 45 minutes~     increases subjective appetite and food intake at the next meal. Food intake will be measured~     immediately following screen-time exposure, and subjective appetite measured throughout the~     study period at 0, 15, 30, 45 and 75 minutes.~   "
138812|NCT01750359|"~     Antidepressants generally do not lead to an immediate relief of symptoms. Most people will~     not see a significant improvement for at least 4 weeks. Studies have generally shown that the~     full benefits of antidepressant therapy may take as long as 8 to 12 weeks. However, this~     timeline is variable among individuals.Curcumin is one of the main curcuminoids isolated from~     this perennial herb. It possesses a variety of pharmacological activities, including~     anti-inflammatory, antiproliferative, antioxidant, and neuroprotective effects. Curcumin has~     been found to possess antidepressant action in various animal models of depression. Chronic~     administration of curcumin has been reported to exert antidepressant-like action in olfactory~     bulbectomy model of depression in rats. Although the mechanism of the antidepressant effect~     of curcumin is not fully understood, it is hypothesized that it acts through inhibiting the~     monoamine oxidase enzyme and modulating the release of serotonin and dopamine.In randomized,~     double-blind, placebo-controlled study 40 patients will be randomized to receive either 500~     mg/day of curcumin or placebo together with antidepressants for 6 weeks.~   "
138813|NCT01750346|"~     Background:~      - Blepharospasm is caused by excessive contraction of the muscles that close the eye. One~     treatment is botulinum neurotoxin (BoNT), which works by weakening those muscles. Like BoNT,~     acetyl hexapeptide-8 (AH-8) works to weaken the muscles, but is available as a skin cream.~     AH-8 is the active ingredient in a number of cosmetic creams used to treat wrinkles.~     Researchers thought that AH-8 cream could be used to treat blepharospasm, but the original~     dose studied was not very effective. They want to try a higher dose of AH-8 in a cream to see~     if it can be a more effective treatment.~      Objectives:~      - To see if AH-8 cream can improve the symptoms of blepharospasm.~      Eligibility:~      - Individuals at least 18 years of age who have blepharospasm that is severe enough to~     require treatment.~      Design:~        -  This study will involve up to eight study visits.~        -  Participants will be screened with a physical exam and medical history. They will answer~          questions about their symptoms. They will also have a blink test to see how severe the~          blepharospasm is. At this visit, participants will receive one of three types of cream.~          One cream will have a low dose of AH-8, one will have a higher dose of AH-8, and the~          other will be a placebo (no AH-8).~        -  One month later, participants will have a followup visit, with tests similar to the~          first visit. They will also receive more of the cream.~        -  One month later, participants will have another visit with the same tests. They will be~          videotaped at this visit to study their facial movements. Those who have responded to~          the treatment will continue to use the cream. Those who have not responded will be~          offered the chance to have BoNT injections, and will stop taking the cream.~        -  One month later, participants who had BoNT injections will have a final visit to check~          for possible side effects. Those who continued to take the cream will continue on the~          study.~        -  The fifth and sixth visits will involve the same tests as before. At the seventh visit,~          remaining participants will be offered the chance to have BoNT injections, and will stop~          taking the cream.~        -  The final visit will check for any side effects from the cream or the injections.~   "
138814|NCT01750333|"~     The aim of this study is to explore whether and how high circulating levels of endothelin-1~     (ET-1) in obese and overweight children may contribute to impair adiponectin (Ad) production,~     release and vascular activity~   "
138815|NCT01750320|"~     The primary aim of this study is to show that the accuracy of Koning Breast CT-guided biopsy~     is at least equivalent to that of stereotactic-guided biopsy.~   "
138816|NCT01750307|"~     Brief summary~      The aim of the study is to provide preliminary data on the relationship of Essential Fatty~     Acids (EFAs) to cognitive and electrophysiological measures of brain and behavioural~     functions in adults with attention deficit hyperactivity disorder (ADHD) and controls. This~     main aim will be achieved in two ways. First the investigators will measure the relationship~     of the various measures to blood levels of EFAs in ADHD cases and controls. Secondly, the~     potential effects of dietary supplementation with EFAs on cognitive-electrophysiological and~     behavioural measures in ADHD cases will be investigated. We will evaluate the extent to which~     changes in neuronal activity and cognitive performance are related to behavioural and~     functional measures over time. This is to be carried out by conducting a randomised~     controlled trial of fish oil supplementation in adults with ADHD (The OCEAN study: Oils and~     Cognitive Effects in Adult Neurodevelopment).~      The study design will be a 6-month double blind placebo control study with a group of 80~     adults with a diagnosis of ADHD. The group will be divided into 40 participants who receive~     EFA dietary supplements and 40 who receive placebo, over a 6-month period. Allocation to EFA~     dietary supplementation and placebo groups will be randomly allocated and blind to both the~     investigator and participants. In addition a sample of 30 controls will take part in baseline~     levels of assessment and be used for case-control comparisons to investigate the links~     between EFA blood levels and cognitive-electrophysiological function at one time point.~      The study design will enable preliminary data to address the following hypotheses:~        1. Changes in cognitive and electrophysiological function (neuronal activity) will be found~          following supplementation with dietary EFAs.~        2. Changes in cognition and/or brain activity will be related to blood levels of EFAs.~        3. Changes in cognitive performance and electrophysiological parameters will correlate with~          behavioural function, affective regulation or functional impairments.~        4. At baseline, case-control differences in EFA blood-levels will be found which will be~          linked to cognitive and electrophysiological function.~   "
138817|NCT01750294|"~     It is estimated that in the United States there are approximately 8 million individuals with~     moderate to severe chronic kidney disease (CKD), not on dialysis. Volume expansion plays an~     important role in the pathogenesis of hypertension in patients with CKD. For this pilot~     study, the investigators hypothesize that administration of chlorthalidone among patients~     with moderate to severe CKD will improve blood pressure (BP).~   "
138818|NCT01750281|"~     The purpose of this study is to treat patients with locally advanced or metastatic NSCLC with~     a combination therapy of selumetinib and two different doses of docetaxel 75mg/m2 or 60 mg/m2~     vs placebo and compare how well each dose affects how their cancer responds. It will also~     help us to understand the tolerability profile of the different dosing regimens in these~     patients~   "
138819|NCT01750268|"~     The goal of the proposed project is to improve the treatment of veterans with co-occurring~     traumatic brain injury (TBI) and hazardous or harmful alcohol use. The PI and coinvestigators~     will conduct a pilot controlled clinical trial of topiramate for the treatment of these~     co-occurring disorders.~   "
138820|NCT01750255|"~     This project aims, through pharmaceutical care in patients with Bipolar I Disorder, improve~     compliance and adherence rate, associated with greater effectiveness and safety of drug~     therapy to help achieve therapeutic goals, and finally to improving the quality of life of~     patients.~   "
138821|NCT01750242|"~     To evaluate DBS device settings and match with the features of the DBS care management~     software.~   "
138822|NCT01750229|"~     The purpose of this study is to evaluate the role of frequency settings on spinal cord~     stimulation in the management of Failed Back Surgery Syndrome (SCS Frequency Study).~   "
138823|NCT01750216|"~     This observational study will evaluate the predictive value of rapid virological response~     (RVR) and early virological response (EVR) on sustained virological response (SVR) by stage~     of liver fibrosis in treatment-naïve patients with chronic hepatitis C genotype 1 initiated~     on treatment with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin). Patients will be~     followed for 48 weeks of treatment and up to 24 weeks of follow-up.~   "
138824|NCT01750203|"~     The objective of this study is to collect wound exudate (fluid) swab samples from Subjects~     who have wounds that show clinical signs of infection, as well as from Subjects who have~     wounds that do not show clinical signs of infection. Swab samples will be collected from~     acute and chronic wounds of different etiologies and these will be analysed for bacteria~     types and markers of infection.~   "
138825|NCT01750190|"~     The purpose of this study is to determine whether FG-4592 is safe and effective in the~     treatment of anemia in chronic kidney disease patients who are not on dialysis.~   "
138877|NCT01749514|"~     The purpose of this study is to evaluate the effects of ACE-536 on anemia in patients with~     low or intermediate-1 risk MDS.~   "
138827|NCT01750164|"~     This study will use tissue or body fluid acquired during standard procedures that are part of~     the patient's care for their cancer, such as surgery to remove tumor tissue or needle~     withdrawal of body fluid containing cancer cells. The tissue or cells will be injected into~     immune compromised mice and the tissue will be allowed to grow to a tumor 1-1.5 cm size. The~     tissue will then be extracted and either frozen, embedded in paraffin, or used for~     engraftment into another generation of mice. The second generation mice will be separated~     into groups and given various treatments.~      Tissue from the participants and from the mouse established tumors, in which the mice have~     either received treatment or have not received treatment, will be used to evaluate the levels~     of various genes that assist in regulating cell growth and cell death. The tumor tissue from~     participants and mice will also be tested for random changes in the genetic material and~     compared to the participant's blood to determine if any of the changes in the genetic~     material correlate with better engraftment of the patient tissue in the mice. It is~     anticipated that 10-30% will have successful engraftment of tumor tissue~   "
138828|NCT01750151|"~     The purpose of this experiment is to investigate the effect of video game playing for 30~     minutes on food intake and subjective appetite. The investigators hypothesize that video game~     playing will affect food intake in children. Food intake will be measured at 30 minutes~     following a glucose (50g glucose in 250ml of water) or sweetened non-caloric (150mg~     Sucralose® in 250ml of water) beverage with or without video game playing. Subjective~     appetite will be measured at 0, 20, 35 and 65 minutes.~   "
138829|NCT01750138|"~     The gastrointestinal tract has many functions; it provides nutrition, produces hormones,~     performs a barrier function, maintains a stable gastrointestinal micro flora and plays an~     important role in the inflammatory process as it is the largest producer of cytokines~     (proteins associated with inflammation). This gut function is impaired after colorectal~     (bowel) surgery. There is evidence to suggest that impaired gut function is associated with~     increased complications. Hence if gut function is preserved, it should equate with better~     outcomes. As a result, there has been increasing interest in treatments called Gut Specific~     Nutrients (GSN), which specifically target gut function. Most notable of them is Glutamine, a~     conditionally essential amino acid and preferred fuel source for intestinal cells. Research~     has shown that glutamine promotes cell growth, increases clearance of harmful organisms from~     the blood, and reduces the surgical stress response. In other words, glutamine has a~     favourable influence on gut function.~      Recent studies from our unit using intravenous glutamine in critically ill patients have~     shown an early return of gut function, which in turn is associated with attenuation of the~     inflammatory response and improved outcomes. It is not known whether oral glutamine is~     associated with a similar outcome. A recent pilot study at our unit suggests an association~     between oral glutamine and early return of gut function. The aim of this research is to~     determine if giving oral glutamine results in an early return of gut function and whether~     this is associated with an attenuation of the systemic inflammatory response.~   "
138830|NCT01750125|"~     The investigators hypothesize that performance of fast-Fourier transformation on the raw~     Doppler signals obtained from ascending aortic blood flow will recreate the pulse wave~     Doppler trace visualized on modern echocardiography machines, and that this will allow for~     the measurement and recording of vascular flow waveforms~   "
138831|NCT01750112|"~     This is a prospective, open, non-comparative and baseline-controlled study to evaluate~     efficacy and safety of Macrolane VRF20 treatment in 40 subjects with pectus excavatum~     deformity.~      Each subject participating in the study will be treated with approximately 50-150 ml of~     Macrolane VRF20. The amount of study product used will be individually determined in order to~     achieve an optimal correction of the deformity in each subject.~   "
138832|NCT01750099|"~     This study divides patients into two groups when they ask for medicine to help relieve the~     pain of contractions. One group will be selected to receive an epidural and another group~     will be selected to receive both a spinal dose and an epidural. The investigators will then~     measure how long it takes to deliver the baby. The investigators think that the group that~     has the combination spinal and epidural will have a faster labor.~   "
138833|NCT01750086|"~     The aim of the study is to assess the relative antiresorptive properties of 2 osteoporosis~     medications when combined with teriparatide.~   "
138834|NCT01750073|"~     This phase II trial studies the side effects and how well giving paclitaxel and~     cyclophosphamide with or without trastuzumab before surgery works in treating patients with~     previously untreated breast cancer. Drugs used in chemotherapy, such as paclitaxel and~     cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing~     the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, may~     block tumor growth in different ways by targeting certain cells. Giving combination~     chemotherapy with or without trastuzumab before surgery may make the tumor smaller and reduce~     the amount of normal tissue that needs to be removed.~   "
138835|NCT01750060|"~     This study is a single-center, randomized, open-label, 3-period, 5-treatment, 6-sequence~     design. A total of 54 eligible subjects will receive three total treatments; one with~     intravenous (IV) infusion and two with the Study System. Each subject will be randomly~     assigned to receive a treatment sequence consisting of Treatment A (IV fentanyl citrate),~     Study System Treatment B (170 mcAmp), and one of three additional Study System treatments~     (140 mcAmp or 200 mcAmp or 230 mcAmp) ~   "
138836|NCT01750047|"~     Object: Every person's pain perception and possible postoperative pain is different. As the~     investigators know, they are affected by many factors. However, the investigators don't know~     whether the smoking factors, alcohol factors, surgery type, education background, etc. will~     affect individual pain perception and possible postoperative pain in Chinese population. This~     study was conducted to investigate the power of these possible affect factors. Method:~     Patients receiving elective surgery under general anesthesia were recruited into this study.~     The investigators measured their preoperative pressure pain threshold (PPT) and pressure pain~     tolerance (PTO)and also investigated the patient's personal information of smoking factors,~     alcohol factors, surgery type, education background, etc. In addition, we retrospectively~     investigated the visual analog scale (VAS) during patient-controlled analgesia (PCA)~     treatment 0 to 48 h after operation as well as the PCA press frequency and drug consumption~     of those patients who received PCA administration.~   "
138837|NCT01750034|"~     The purpose of this study is to better understand how to best care for burn wounds.~   "
138838|NCT01750021|"~     Obesity has become a global epidemic, and treating and preventing obesity appears to be one~     of the world's greatest challenges. The disorder is associated with a wide range of metabolic~     and hormonal changes, including the development of insulin resistance, changes in adipose~     tissue function, increased levels of blood lipids, cardiovascular disease and obesity induced~     fatty liver. Obesity is characterized by inflammation in adipose tissue, altered fat storage~     capacity and increased exchange of lipids between adipose tissue and blood, and increased~     secretion of cytokines from adipose tissue. Cytokines are believed to play a central role in~     the regulation of adipose tissue, the size of adipocytes and other metabolic conditions.~      The hepatic synthesis of lipoproteins and interaction with adipose tissue is essential for~     the body's energy storages. The central role of the liver in energy supply, fat storage and~     normalization of blood values implies the importance of investigating the interaction between~     adipose tissue and liver to increase knowledge about the morbidity of obesity. Central~     obesity and insulin resistance are clear risk factors for the development of fatty liver, but~     the importance of diet is unclear. The common perception is that fatty liver condition can be~     improved by a reduction in dietary fat and cholesterols, but the relationship is unclear, and~     contradictory findings occur in epidemiological studies. It is therefore necessary to better~     understand the impact of the different macro-nutrients.~      The purpose of this study is to determine whether two weight reducing diets with equal~     calorie levels that contain high or low fat differentially affects the adipose tissue~     function, distribution of body fat, as well as tissue, blood and urine levels of inflammatory~     markers, lipids, vitamins, hormones and other substances that may be related to metabolically~     health.~   "
138839|NCT01750008|"~     The purpose of this study is to compare the outcomes of two uterine-conserving treatment~     alternatives for symptomatic uterine fibroids: laparoscopic myomectomy (LM) and global~     fibroid ablation (GFA) using the Halt System. Laparoscopic ultrasound (LUS) is a standard~     step prior to the GFA procedure but has not been a standard step prior to LM. Incorporating~     laparoscopic ultrasound as a first step prior to both treatments allows the surgeon to have~     equal access to valuable imaging information and to plan treatment accordingly. By~     randomizing the subject immediately after laparoscopic ultrasound, selection bias toward one~     treatment or the other following the LUS is eliminated.~   "
138840|NCT01749995|"~     A Comprehensive Geriatric Assessment (CGA) has become a fundamental aid in the evaluation and~     treatment planning of older cancer patients. Systematic reviews of trials of geriatric~     assessments have shown effectiveness when interventions are implemented. Although CGA is a~     fundamental tool in the care of the geriatric patient, the integration and application of~     this tool in oncologic practice are still in evolution. Cognition is one of the domains~     examined within a CGA. Studies have noted that up to 25% to 50% of older patients had~     cognitive abnormalities that warranted further evaluation. Cognitive dysfunctions can~     influence the ability to weigh the risks and benefits of cancer therapy, to comply with the~     suggested treatment plan, and to recognize the symptoms of toxicity that need medical~     attention. Recently, the Freund Clock Drawing Test (CDT) has been proposed as a quick and~     simple screening tool to assess cognitive dysfunction. A retrospective analysis on 105 cancer~     patients at the General Hospital Groeninge showed that a cut-off score of ≤ 4 for the CDT has~     a good AUC, sensitivity and specificity.~      Aims~        1. To validate the Clock Drawing Test as a screening tool to identify elderly cancer~          patients in need of a more in-depth cognitive evaluation within a comprehensive~          geriatric assessment (CGA)~        2. Further registration of data in a database coupled to the Cancer Registry in the General~          Hospital Groeninge as set up by the PROGERCAN study~   "
138841|NCT01749982|"~     Roughly 140 million people worldwide are chronically exposed to As-contaminated drinking~     water at concentrations exceeding the World Health Organization (WHO) standard of 10 µg/L.~     Arsenic is a class I carcinogen known to cause several types of cancer and ischemic heart~     disease. Metabolism of inorganic As (InAs), which facilitates urinary As excretion, relies on~     one-carbon metabolism and involves two methylation steps; both utilize S-adenosylmethionine~     (SAM) as the methyl donor. SAM biosynthesis relies on B vitamins including folate and B12 for~     the recruitment and transfer of methyl groups, but other nutrients, including choline and~     betaine, also contribute to the methyl pool. Our recent findings from a cross-sectional study~     of Bangladeshi adults exposed to a wide range of As concentrations in drinking water show~     that plasma choline and betaine concentrations are positively associated with As methylation.~     These findings suggest that choline and/or betaine may play an important role in As~     methylation and elimination and that simple interventions may have therapeutic potential for~     the many populations at risk for As-induced health effects.~      The investigators aim to recruit and follow 60 participants for this pilot study which will~     allow us to 1) assess the acceptance of choline and betaine supplements, 2) monitor~     participants for any potential side effects, 3) identify any difficulties that might be~     encountered in daily follow-up, and 4) generate preliminary data regarding the effects of~     choline and/or betaine supplementation on arsenic methylation.~   "
138842|NCT01749969|"~     Primary Objectives:~        -  To determine the maximum tolerated dose of SAR650984 (isatuximab) with lenalidomide and~          dexamethasone (LD) in patients with relapsed or refractory multiple myeloma.~        -  Expansion Phase Only: To further evaluate preliminary evidence of antitumor activity~          (objective response rate [ORR]) of SAR650984 (isatuximab) in combination with LD using~          International Myeloma Working Group (IMWG) criteria.~      Secondary Objectives:~        -  To evaluate the safety, including immunogenicity, of SAR650984 (isatuximab) in~          combination with LD in relapsed or refractory multiple myeloma. The severity, frequency~          and incidence of all toxicities will be assessed.~        -  To evaluate the pharmacokinetics (PK) of SAR650984 (isatuximab) when administered in~          combination with LD and the PK of lenalidomide in combination with SAR650984 and~          dexamethasone.~        -  To assess the relationship between clinical (adverse event [AE] and/or tumor response)~          effects and pharmacologic parameters (PK/pharmacodynamics), and/or biologic (correlative~          laboratory) results.~        -  For the dose expansion phase, estimate the activity (ORR) using IMWG defined response~          criteria of SAR650984 (isatuximab) plus LD.~        -  To describe progression-free survival (PFS) in patients treated with this combination.~   "
138843|NCT01749956|"~     The purpose of this Phase II study will be to investigate the antiangiogenic agent,~     aflibercept, in combination with chemoradiation as preoperative treatment for patients with~     stage II/III rectal cancer, followed by 4 months of FOLFOX6 plus aflibercept adjuvantly.~   "
138844|NCT01749943|"~     Evaluate a method of testing the strength of five key lower limb muscle groups using a~     hand-held strength gauge (dynamometer).~   "
138899|NCT01749228|"~     This is a open Label, balanced, randomized, single dose, two-treatment, two-sequence,~     two-period, crossover pivotal study. The purpose of this study is to assess the~     bioequivalence between Test Product and the corresponding Reference Product under fed~     condition in healthy, adult human subjects.~   "
138845|NCT01749930|"~     In participants with a diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT),~     the primary objective is to demonstrate that the mean IOP reduction after 3 months of~     treatment with BOL-303259-X once daily (QD) is non-inferior to timolol maleate 0.5% twice~     daily (BID). The secondary objective is to demonstrate the superiority of BOL-303259-X QD to~     timolol maleate 0.5% BID. This assessment will be performed if the non-inferiority of~     BOL-303259-X QD to timolol maleate 0.5% BID is determined. An open label safety phase will be~     conducted at the end of Visit 6 (3 months) where all participants will receive BOL-303259-X~     QD for an additional 3 months.~   "
138846|NCT01749917|"~     The investigators conducted an intervention based in proprioceptive exercises and balance~     tasks. The investigators also carried out a brief intervention in manual dexterity.~      The study hypothesis is that a brief intervention in upper extremities and a exercise program~     can increase functionality in Parkinson.~   "
138847|NCT01749904|"~     In participants with a diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT),~     the primary objective is to demonstrate that the mean IOP reduction after 3 months of~     treatment with BOL-303259-X once daily (QD) is non-inferior to timolol maleate 0.5% twice~     daily (BID). The secondary objective is to demonstrate the superiority of BOL-303259-X QD to~     timolol maleate 0.5% BID. This assessment will be performed if the non-inferiority of~     BOL-303259-X QD to timolol maleate 0.5% BID is determined. An open label safety phase will be~     conducted at the end of Visit 6 (3 months) where all participants will receive BOL-303259-X~     QD for an additional 9 months.~   "
138848|NCT01749891|"~     The general objective of this study is to evaluate the safety and efficacy of ophthalmic~     intravitreal injections of ALG-1001 in human subjects with wet age-related macular~     degeneration (Wet AMD). This study builds upon the safety and efficacy results of numerous~     animal studies and an earlier Phase I Human Study in end-stage diabetic macular edema~     patients.~   "
138849|NCT01749878|"~     Phase 1, first-in-human, randomized, ascending single-dose, placebo-controlled, double-blind~     study of the safety, tolerability, and bioeffect of REGN1500~   "
138850|NCT01749865|"~     This is a randomized controlled study. About 200 patients with hepatocellular carcinoma who~     underwent radical resection will be included. The patients will be randomized to group A~     (receive CIK treatment) or group B (just regularly follow up) without any anti-cancer~     treatment after resection of HCC, and the randomize ratio will be 1:1.~   "
138851|NCT01749852|"~     The aim of this study is to investigate if dark chocolate rich in polyphenols decreases body~     weight/ body fat in the overweight and obese adult population.~   "
138852|NCT01749839|"~     Past PRP therapy is not sufficient for some part of patients.In this clinical research, The~     integrated application of PRP with extracellurar matrix and some type of stem cell technique.~   "
138853|NCT01749826|"~     The PI is interested in learning how the immune system and the inflammation process is~     effected by acute and chronic opioid exposure. Preliminary evidence in animal models show~     that acute opioid exposure leads to decreased inflammatory responses, while chronic opioid~     exposure causes increased inflammatory responses, as measured by local cytokine release at~     the site of injury. Translating these findings to humans will lead to important new~     mechanistic knowledge that may ultimately improve our ability to treat pain.~   "
138854|NCT01749813|"~     This study investigates whether the specific carbohydrate diet (SCD) can maintain clinical~     remission in pediatric and adult patients with Crohn's disease.~   "
138855|NCT01749800|"~     The overall goal of the proposed project is to perform a preliminary study to assess the~     potential effects of galvanic vestibular stimulation (GVS) on the outcomes of a cognitive~     test of attention and the outcomes of robot-assisted upper-limb rehabilitation.~   "
138856|NCT01749787|"~     The purpose of this study is to determine the safety and tolerability of PRTX-100 when~     various doses are given 5 times at weekly intervals to patients with active rheumatoid~     arthritis that are taking methotrexate or leflunomide. The drug is administered in a~     physician's office via an intravenous infusion. PRTX-100 may be effective in rheumatoid~     arthritis by suppressing the immune responses.~      PRTX-100 is a highly-purified bacterial protein called Staphylococcal Protein A. In this~     study, cohorts of patients with active RA will receive sequentially higher doses of PRTX-100.~     There will be an inactive placebo cohort for comparison. Patients who do not attain low RA~     disease activity, by a commonly used measure, will leave the study at 3 months after their~     first dose of study drug.~   "
138857|NCT01749774|"~     The purpose of this study is to determine the feasibility and effect of a program including~     information, counseling and an individualized physical activity program on physical and~     psychological health during and after chemotherapy in patients with testicular cancer. It is~     hypothesized that the patients are able to complete the intervention with individual~     adjustments.~   "
138858|NCT01749761|"~     It is very common for hemodialysis patients to have problems with low blood pressure while on~     hemodialysis. Low blood pressure on dialysis is not a good thing and it is associated with an~     increased risk of death and hospitalizations. It might be possible to minimize or even~     prevent these low blood pressure episodes with a software that can be added to the dialysis~     machine which detects the patient's changes in blood pressure and automatically slows down~     how much fluid is being removed from the person.~      The investigators hypothesize that a blood pressure guided biofeedback system (called~     BioLogics RR) will result in a 30% reduction in the number of hypotensive episodes on~     hemodialysis.~   "
138859|NCT01749748|"~     To delineate if the chemical composition (lipid and water) in the presumably normal breast of~     the high risk women is different from those of the low risk group.~   "
138860|NCT01749735|"~     The aim of this study is to compare the effect of transcranial direct current stimulation and~     functional upper extremity task training to functional upper extremity task training alone.~     The functional upper extremity task training uses the Armeo Spring robotic arm to support the~     limb while playing functional task games on a computer.~      Specific Aims:~        1. To demonstrate that tDCS combined with upper extremity functional task training in a~          virtual environment is more effective than functional task training in a virtual~          environment with sham tDCS.~        2. To compare cortico-excitatory changes following training with tDCS vs. sham stimulation,~          using paired- and single-pulse transcranial magnetic stimulation as a tool to measure~          cortical excitability.~   "
138861|NCT01749722|"~     To evaluate the safety of using the NaviAid™ G-Eye system during Colonoscopy~   "
138862|NCT01749709|"~     Clinical study including 60 subjects to investigate the effect of daily music listening on~     stress parameters during the acute phase of stroke and on recovery. 20 subjects listen to~     instrumentala music, 20 listen to music with lyrics and 20 are controls. Outcome measures in~     the acute phase are levels of physiological stress parameters (cortisol, endorphin,~     oxytocin). Outcome measures in the recovery phase are cognitive capabilities and mood~     measured with standard clinical tests. Follow-up time is 6 months.~   "
138863|NCT01749696|"~     The aim of our study is to investigate the alterations in connective tissue of vaginal wall~     in patients with and without pelvic organ prolapse (POP).~   "
138864|NCT01749683|"~     The goal of this study is to use MCE (myocardial contrast/perfusion echocardiography) to~     study and compare short/long term change of myocardial perfusion abnormality and cardiac~     outcome in diabetic patients after nonfatal MI (heart attack), who are treated with different~     glucose control agents.~   "
138865|NCT01749670|"~     There is accumulating evidence that genetic expression plays a role in autism spectrum~     disorder, but the regulation of such genes is poorly understood. Small RNA particles, called~     microRNA (miRNA), have the ability to alter gene expression. These particles can be packaged~     and released from brain cells into the blood. Changes in miRNA may contribute to the patterns~     observed in autism spectrum disorder.~      The purpose of this study is to identify small RNA particles that regulate gene expression in~     autism spectrum disorder. The goal is to identify miRNA expression patterns which may improve~     our understanding and diagnosis of autism spectrum disorder.~   "
138866|NCT01749657|"~     The lack of high quality evidence to guide conservative care for patients with posterior~     tibial tendon dysfunction (PTTD) has led to controversy over clinical care. Numerous orthotic~     devices are available to avoid a costly and debilitating surgery but no consensus on which to~     use has been made. The current study aims to link biomechanical testing of selected devices~     to clinical outcomes in subjects with PTTD after wearing a device for 12 weeks.~   "
138867|NCT01749644|"~     Pseudomonas is a common and virulent respiratory bacteria in patients with Cystic Fibrosis~     (CF). With time, the infection with Pseudomonas becomes chronic and very difficult to~     eradicate. The standard treatment of chronic Pseudomonas infection is inhaled Tobramycin~     which is given every other month.. Inhalation of Tobramycin was proven as an effective~     treatment that improves the respiratory function and reduces the concentration of bacteria in~     the sputum. However, inhaled treatment lasts between 15 to 30 minutes twice a day and~     therefore adherence is a major problem. The effect of switching from inhalation treatment to~     inhaler treatment on patient's adherence and quality of life has not been studied.~   "
138868|NCT01749631|"~     The purpose of this study was to record the effectiveness of sevoflurane for intubation in~     Egyptian, non-obstetric, difficult to intubate (DTI) patients undergoing surgery in regards~     to the rate of intubation success.~   "
138869|NCT01749618|"~     Rheumatologists treating patients with seronegative arthritis will be randomized to treat~     their patients to a target or to treat their patients under their usual standard of care. All~     physicians will perform an initial chart audit. Following the initial chart audit, all~     physicians in the treat-to-target group will receive accredited educational training. Six~     months after the initial chart audit, all physicians will perform a repeat audit to see if~     patients are assessed more systematically and treated to a target of low disease state.~   "
138870|NCT01749605|"~     Pilot study to compare the efficacy and safety of 3-day, twice-daily regimens of~     nitrofurantoin and ciprofloxacin in emergency department (ED) patients presenting with UBC.~   "
138871|NCT01749592|"~     -  As the left and right hemisphere are specialized for different auditory tasks, the~          proposed study aims at demonstrating different consequences of right or left-sided~          deafness for the affected individual.~        -  Furthermore, the question should be answered if auditory deficits and plastic changes~          can be partially reversed by cochlear implantation of the deaf ear.~        -  Multicenter, prospective, open, non-randomized clinical trial with 5 patients with~          right-sided and 5 patients with left-sided sensineural deafness.~        -  Pre-operative: Audiometry, Sound Localization Audiometry, PET, EEG/MEG~        -  Comparison of pre-operative investigations with 10 healthy subjects (age and gender~          matched control group)~        -  Cochlea implantation~        -  Follow-up Visits at 3, 6, 9 and 12 month post-operative: Audiometry, Sound Localization~          Audiometry, PET, EEG, Questionnaires~        -  Trial with medical device~   "
138872|NCT01749579|"~     Sixty patients who refer to the emergency ward and need any painful procedure in the ward are~     randomized into 2 groups. One group is sedated before the procedure using propofol-fentanyl~     and the other with midazolam-fentanyl, with the same depth of sedation. The two groups will~     be compared regarding recovery time and other parameters described below.~   "
138873|NCT01749566|"~     Pre-exposure prophylaxis (PrEP) is an HIV prevention strategy in which HIV medicines are used~     by a person before they are exposed to HIV in order to decrease his or her chance of getting~     infected. In this study, we will investigate a new PrEP strategy in women using a drug called~     maraviroc, a medicine used in the treatment of HIV infection called a CCR5 antagonist. We~     hypothesize that maraviroc could be a particularly good drug for PrEP because it achieves~     high concentrations in the genital tract in women and decreases the number of HIV-susceptible~     cells in the genital tract, and thus could potentially be dosed in more favorable ways than~     the current PrEP drugs.~      In order to further evaluate this PrEP strategy, we plan to measure the amount of maraviroc~     in the blood and genital tract of HIV-negative healthy female volunteers before, during, and~     after they are given maraviroc dosed either in the standard (twice a day) or reduced (once a~     day) dose for 7 days compared with women who are not given maraviroc. We will also study~     immune cells from the blood and genital tract from these women to see if maravoric has an~     effect on these cells that would prevent them from becoming infected with HIV.~   "
138874|NCT01749553|"~     To Determine whether an eight-week posterior shoulder stretch was effective in increasing~     dominant arm internal rotation(IR) and horizontal adduction (HAd) range of motion (ROM) in a~     group of overhead athletes identified as having tightness of their posterior shoulder~     structures.~   "
138875|NCT01749540|"~     The purpose of this study is to evaluate the effects of ACE-536 in patients with~     beta-thalassemia.~   "
138876|NCT01749527|"~     We hypothesised that in women with stress urinary incontinence, the severity of leakage on a~     24 hour pad test was affected by activity.~   "
138878|NCT01749501|"~     Those infants who received the muscle relaxation in combination with the vagolytic (reduce~     vagus nerve impulses) and pain medication will have reduced time to successful intubation~     (placement of tube into the lungs), a decrease in the number of attempts, and better~     intubation conditions reported by the practitioner. The objectives of the study include: 1.)~     Does the medication protocol outlined in this study provide optimal intubation conditions?~     (i.e.good jaw relaxation, open and immobile vocal cords and suppression of gag reflex) 2.)~     Does the addition of a muscle relaxant prior to intubation contribute to less attempts and~     achieving successful intubation as opposed to neonates who do not receive the muscle~     relaxant.~   "
138879|NCT01749488|"~     The main objective of this study is to evaluate the impact of the intervention of a dietician~     on the energy balance accumulated over seven days of intensive care.~      Energy balance is defined as the difference between the target recommended energy and total~     calorie intake actually received.~      This is a randomized-cluster study; participating centers are randomized into experimental~     and control groups.~   "
138880|NCT01749475|"~     Most of the reports on hypnosis in the literature have focused on pain control during minor~     operations. With this study we aimed to evaluate the role of hypnosis on sedation for~     transesophageal echocardiography and compare it with commonly used sedative midazolam.~   "
138881|NCT01749462|"~     The purpose of the investigation is to confirm the ADR development and the contributing~     factors possibly having an impact on the safety under the post-marketing actual use of Oxis 9~     mcg Turbuhaler.~   "
138882|NCT01749449|"~     The purpose of the current study was to examine the impact of macronutrient intake (PRO, 15%~     vs. 35%) and meal frequency (3 vs. 6 meals/day) on body composition, postprandial~     thermogenesis and plasma adipokines before and after 28days each of EB (28days) and ED (25%;~     28days) in overweight individuals. We hypothesize that HP will elicit more favorable body~     composition, thermogenic, and cardiometabolic changes than HC intakes and the magnitude of~     change will be greatest in those consuming HP meals more frequently.~   "
138883|NCT01749436|"~     General anesthesia results in the development of atelectasis in the dependent areas of the~     lungs exposing patients to an increased risk of hypoxemia. During laparoscopic procedures,~     pneumoperitoneum increases already present atelectasis.~      Several methods have been suggested to reduce the impact of atelectasis during surgery.~     However, few intraoperative modalities for the diagnosis and monitoring of atelectasis are~     available. Lung ultrasound imaging is a promising non-invasive, non-radiant, portable and~     easy to use tool that as yet to be studied in the intraoperative setting.~      This observational study will aim to clarify the role of lung ultrasound imaging during~     laparoscopic surgery for the diagnostic and monitoring of atelectasis.~      This study is designed to:~        -  Demonstrate a link between the lung ultrasound aeration score, the partial pressure of~          oxygen in arterial blood (PaO2) / fraction of inspired oxygen (FiO2) ratio and the~          oxygenation index.~        -  In the event of intraoperative desaturation, study the impact of positive end-expiratory~          pressure (PEEP) and/or increase of FiO2 on the aeration score.~        -  Study the impact of pain on diaphragmatic function and the aeration score.~      Our hypothesis is that lung ultrasound imaging allows detection of lung aeration changes~     associated with induction of general anesthesia, pneumoperitoneum, emergence from anesthesia~     and changes occurring during the stay in the recovery room.~   "
138884|NCT01749423|"~     This study will evaluate the effectiveness of OnabotulinumtoxinA to prevent headaches in~     patients with Chronic Migraine.~   "
138885|NCT01749410|"~     This study will evaluate the effectiveness and benefit of treatment with onabotulinumtoxinA~     in Chronic Migraine patients who have received a minimum of 7 treatment cycles.~   "
138886|NCT01749397|"~     This phase I trial studies the side effects and best dose of veliparib when given together~     with floxuridine in treating patients with epithelial ovarian, primary peritoneal cavity, or~     fallopian tube cancer that has spread to other places in the body. Veliparib may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as floxuridine, work in different ways to stop the growth of tumor cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Giving veliparib together with floxuridine may kill more tumor cells.~   "
138887|NCT01749384|"~     This phase I trial studies the side effects of and best dose of tivantinib when given~     together with bevacizumab in treating patients with solid tumors that have spread to other~     areas of the body or cannot be removed by surgery. Tivantinib may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as~     bevacizumab, may block tumor growth in different ways by targeting certain cells. Bevacizumab~     may also stop the growth of cancer by blocking blood flow to the tumor. Giving tivantinib~     together with bevacizumab may work better in treating tumor cells.~   "
138888|NCT01749371|"~     A dietary antioxidant, alpha-tocopherol, will be used to potentially attenuate Vitamin E~     short- and long-term losses in plasma and adipose, reverse the oxidative stress of burn~     injury and, in the process, decrease the secondary consequences of burn injury, including~     lung injury and impaired wound healing. This may improve the quality of life of the burn~     patient by preventing pathophysiology that may result from oxidative stress and may reduce~     hospital stay. Our research will lay the foundation for the future development of effective,~     safe, and economic therapeutic interventions to treat burn injury-associated metabolic~     abnormalities. Also, it will provide the basis for the development of supplemental~     regulations and pharmacotherapy to treat burn patients with vitamin E. The risks are very~     reasonable in relation to the anticipated benefits to our subjects because a) vitamin E is a~     simple vitamin that is abundant and approved for clinical use, and b) the subjects will be~     monitored consistently for the minimal increased tendency to bleed.~   "
138889|NCT01749358|"~     This study is about rehabilitation of arm function after a stroke. The investigators are~     testing the dosage of therapy that is needed for meaningful recovery of arm and hand~     function. Dosage of therapy refers to the amount of time (in this case, the total number of~     hours) that a person participates in treatment. The investigators hope to learn how much~     therapy time is needed in order for change to occur in arm and hand function after a person~     has had a stroke. Eligible candidates must have had a stroke affecting the use of an arm or~     hand at least 6 months ago.~   "
138890|NCT01749345|"~     This is a cross-sectional study of six hundred adults with type 2 diabetes, (300 White and~     300 African-American) who will be recruited from two primary care sites to determine how~     social determinants of health impact diabetes outcomes. The first aim is to investigate the~     role of psychosocial factors and SES on diabetes care processes and outcomes. The second aim~     is to investigate the influence of community and neighborhood characteristics on diabetes~     care processes and outcomes. Finally, we will examine the contribution of social determinants~     of health to ethnic differences in diabetes care processes and outcomes. Clinical and~     metabolic measures will be abstracted from the electronic medical records. Outcome variables~     include hemoglobin A1c, blood pressure, LDL-Cholesterol and quality of life.~   "
138891|NCT01749332|"~     The purpose of this study is to draw blood from vessels near the liver in patients undergoing~     liver surgery. This will be performed in both patients with cancer in order to learn more~     about circulating tumor cells, proteins and DNA mutations in the blood.~      The blood in patients with colorectal cancer with liver metastases will be compared to blood~     taken from patients that do not have cancer that do not have cancer.~      Inclusion of patients with benign pathology will allow for the establishment of normal~     values which currently do not exist. We will then study whether tumor mutations can be used~     to predict recurrence and survival patterns.~   "
138892|NCT01749319|"~     The primary objective of this study is to characterize baclofen pharmacokinetics following~     oral and intravenous administration in patients who are on chronic oral baclofen therapy. The~     secondary objective is to determine the safety profile of an IV baclofen formulation.~      This study is a randomized crossover study with two treatment arms. All subjects will receive~     a dose of oral baclofen and a dose of IV baclofen on separate study days. Whether the oral or~     intravenous form is given on the first study day will be randomized in a 1:1 manner.~      The pharmacokinetic and tolerability information gained from this study will support the~     development of further studies to assess the use of IV baclofen to prevent or treat baclofen~     withdrawal syndrome.~   "
138893|NCT01749306|"~     The purpose of this study is to evaluate the efficacy and safety of ABH001 in the treatment~     of patients with epidermolysis bullosa who have wounds that are not healing.~      It is hypothesized that ABH001 may initiate and continue wound healing in patients with~     epidermolysis bullosa.~   "
138894|NCT01749293|"~     Allogeneic stem cell transplantation is a potentially curative treatment for patients with~     many hematologic malignancies (e.g. leukemia, lymphoma, and myeloma with high risk of~     relapse). This process requires a suitable donor. The best case scenario involves an Human~     Leukocyte Antigen (HLA) matched sibling donor. However, this type of donor is not always~     available. Donor registries can provide another source for matched unrelated donors, but this~     may take valuable time delaying treatment for the transplant recipient. Donor availability~     remains a significant barrier to the use of allogeneic (from a donor) stem cell transplant.~     This issue disproportionately affects patients of minority backgrounds. Novel strategies to~     improve outcomes using alternative donors are desperately needed.~      Haploidentical transplants are an alternative which provides a readily available donor in the~     form of a partially HLA matched family member. This provides for more potential donors and~     the donors can be selected based on other factors that can play a role in transplant success~     (e.g. age, gender, KIR alloreactivity). Recent advances in transplant techniques have greatly~     improved success rates with haploidentical transplants although disease relapse has remained~     as issue.~      This trial aims to provide an alternative transplant option for patients with hematologic~     malignancies who require bone marrow transplantation but lack an HLA identical donor. The~     investigational component of this study is the combination of the Fludarabine/ Busulfan/~     Total Body Irradiation conditioning regimen and the HLA Haploidentical Transplant with~     post-transplant Cyclophosphamide.~   "
138895|NCT01749280|"~     The aorta is the main blood vessel that comes out of the heart and distributes blood to the~     whole body. In some people, the aorta becomes swollen (aneurysm) and bursts, especially as it~     passes through the abdomen. These 'abdominal aortic aneurysms' often occur without symptoms~     and can burst or rupture without warning. This usually leads to death and represents the~     thirteenth commonest cause of death in the United Kingdom. In this study, we are looking at a~     new technique that can look at the aortic aneurysm using magnetic resonance imaging; a~     technique that does not require x-rays or radiation. We have recently shown that, using~     magnetic resonance combined with a new imaging agent USPIO, we can detect 'hotspots' of~     activity in these aneurysms that seem to predict which aneurysms grow rapidly, and are~     therefore potentially at risk of rupture. We here propose to conduct a study in Edinburgh~     that will invite all patients who are under surveillance because of an aneurysm. We will~     image these patients using this novel technique and see if we can identify which patients~     burst their aneurysm, have an aneurysm that grows so large it needs to have surgery, or die.~     This will be important to establish as it will potentially lead to a new way of managing~     people that could ultimately save lives. This is particularly timely as national screening~     and surveillance programmes are currently being launched.~   "
138896|NCT01749267|"~     The objective of this study was to analyze the radiographic density of digital subtraction~     radiographs after SMART restoration with partial caries removal in primary molars at 6 and 12~     months.~   "
138897|NCT01749254|"~     Cardiovascular disease is the leading cause of death in Scotland and the Western World.~     Approaches to improve the identification of vulnerable or ruptured coronary atherosclerotic~     plaques are urgently needed to help risk stratification, to identify patients for intensive~     therapies, and to provide novel biomarkers for the development of anti-atherosclerotic drug~     interventions. Using positron emission tomography, we have recently shown that sodium~     18-fluoride uptake holds major promise as a novel marker of plaque vulnerability and rupture.~     Here we wish to characterise coronary atherosclerotic plaque using 128-multidetector computed~     tomography combined with 18-fluorodeoxyglucose and sodium 18-fluoride positron emission~     tomography and Virtual histology-intravascular ultrasound in 80 patients with stable and~     unstable coronary artery disease. This has the potential to provide an innovative and highly~     valuable translational model with which to test novel therapeutic interventions targeted at~     reducing atheroma and plaque rupture. This could have major implications for the future~     treatment of cardiovascular disease.~   "
138898|NCT01749241|"~     Inflammation occurs after any type of incisional surgery. This study will evaluate the~     efficacy of Loteprednol etabonate ointment vs. Soothe ointment (vehicle) for postoperative~     inflammation after routine eyelid surgery.~   "
138902|NCT01749189|"~     This study will investigate the effects of a soy/dairy protein blend on muscle growth and~     strength. In sports nutrition and in aging it is important to have healthy muscles. This can~     be achieved with exercise and nutrition. Consumption of protein following resistance exercise~     can promote healthy muscle growth and help improve strength. Young healthy men will be~     studied during a 12 week resistance exercise training program and be given protein~     supplements every day during the study. The hypothesis is that a blend of soy, whey and~     casein will induce a greater muscle gain and strength increase than the control.~   "
138903|NCT01749176|"~     Randomized controlled trial testing the efficacy of a text messaging intervention in a low~     income, low health literacy group of Latino patients. Project Dulce 2.0 (PD 2.0) will address~     barriers to participation in health education classes, increasing adherence to treatment and~     medications and improving diabetes self management behaviors and skills. Two community clinic~     organizations that provide services to a large proportion of Latino patients with type 2~     diabetes will participate to randomize 200 patients into one of 2 arms: standard diabetes~     management care (control) only or text messaging and standard care. Comparisons between~     groups will evaluate clinical, behavioral and psychosocial outcomes.~      Intervention: Standard Care and Text Messaging. All participants will receive standard~     diabetes care provided by primary care providers at the clinic. Of the 100 that are~     randomized to the intervention arm will be given instructions on how the text messaging~     component will be addressed throughout the duration of the study.~   "
138904|NCT01749163|"~     Incretin hormones (GLP-1 and GIP) released from the intestine in response to meal ingestion~     augment insulin secretion from the pancreas to help maintain glycemic control. Studies in~     vitro and in vivo have shown that these incretin hormones also have functional effects in~     other tissues independent of the insulin secretory response. Both GLP-1 and GIP stimulate~     insulin secretion in a glucose-dependent manner, however the glucose-dependency of their~     extra-pancreatic effects has not been examined in vivo. By using pancreatic clamp methodology~     during euglycemic and hyperglycemic conditions we will test the hypothesis that~     extra-pancreatic effects of GLP-1 and GIP are glucose-dependent.~   "
138905|NCT01749150|"~     This Phase II, open-label, parallel-arm study will evaluate the safety, tolerability,~     pharmacokinetics and antiviral activity of ritonavir-boosted danoprevir in combination with~     Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) in treatment-naïve patients of Asian~     origin with chronic hepatitis C genotype 1. Patients will receive danoprevir 125 mg plus~     ritonavir 100 mg as fixed dose tablet orally twice daily in combination with weekly Pegasys~     180 mcg subcutaneously and Copegus 1000-1200 mg orally daily in divided doses. Treatment~     duration is 12 weeks in patients without cirrhosis and 24 weeks in patients with compensated~     cirrhosis.~   "
138906|NCT01749137|"~     The purpose of this study is to evaluate the effects of RM-493 on mean percent body weight~     loss, and other weight loss parameters as well as Pharmacokinetic (PK) profile, and~     ambulatory blood pressure in obese patients. The study is designed to evaluate the efficacy~     and tolerability of a single dose of RM-493. The study drug (RM-493 and placebo) will be~     administered subcutaneously in a blinded fashion.~   "
138907|NCT01749124|"~     This is a pilot study for a novel, automated telephone system called My Coach Connect. The~     purpose of the study is to evaluate the feasibility and effectiveness of this telephone tool~     while engaging clients and providers in discussion groups and surveys to better understand~     how this tool impacts the care provided and their overall experience in healthcare.~   "
138908|NCT01749111|"~     The purpose of this study is to determine whether cyclophosphamide post bone marrow~     transplant increases the rate of patients alive, in remission and without immunosuppression,~     one year after transplant, when compared with the combination of methotrexate and calcineurin~     inhibitor~   "
138909|NCT01749098|"~     To assess if PF-04958242 can attenuate the ketamine-induced cognitive impairment in verbal~     learning and memory, episodic memory and spatial working memory in healthy volunteers.~   "
138910|NCT01749085|"~     The study aims to determine what effect a high fat meal will have on the drug exposure of~     PF-04449913. The study also aims to determine the effect of a strong enzyme (CYP3A4)~     inhibitor on drug exposure of PF-04449913.~   "
138911|NCT01749072|"~     In the National Comprehensive Cancer Network (NCCN) guideline for NSCLC, epidermal growth~     factor receptor-tyrosine kinase inhibitor (EGFR-TKI) is recommended as the third-line~     treatment for EGFR gene mutation negative NSCLC patients who failed to the first-line~     platinum doublet chemotherapy [i.e. paclitaxel-carboplatin (PC) or gemcitabine-cisplatin~     (GP)] and the second-line chemotherapy with docetaxel or pemetrexed. But as we know, if~     patients had no EGFR gene mutation, EGFR-TKI treatment is not effective. The overall survival~     is short and the objective response rate is low. As for EGFR gene wild type patients with~     good performance status, besides EGFR-TKI treatment, other first generation cytotoxic drugs~     i.e. vinorelbine or ifosfamide maybe an alternative treatment. So the purpose of this~     clinical trial is to compare the effectiveness and safety of vinorelbine-ifosfamide with~     gefitinib in advanced or metastatic EGFR gene mutation negative NSCLC patients.~   "
138912|NCT01749059|"~     The purpose of this study is to evaluate the impact of implementing a universal pulse~     oximeter screening as a way to detect critical congenital heart disease in otherwise~     well-appearing newborns.~   "
138913|NCT01749046|"~     The purpose of this study is to determine weather Remegal in fixed dosage 1500 mg/daily is~     effictive and safe in patients with epilepsy with partial seizures~   "
138929|NCT01748838|"~     The purpose of this study is to assess the safety and tolerability of CTX-4430 capsules taken~     orally once daily in normal healthy volunteers. CTX-4430 is being developed to treat lung~     inflammation that occurs in cystic fibrosis (CF). This study includes two-parts: Part 1~     assesses single dosing; and Part 2 assesses repeat dosing for 14 days. Each part will include~     several dosages. During the single-dose part of the study, following a 14-day washout period,~     two cohorts will be assessed for potential effects on tolerability when fed at the time of~     dosing. For both parts of the study, blood samples will be collected for PK assay validation.~   "
138964|NCT01748383|"~     The purpose of this study is to test the hypothesis that the intracoronary transplantation of~     autologous mononuclear and CD 133 + bone marrow cells will improve left ventricular~     contractile function and will reduce the combined end points after the primary STEMI~     (mortality, recurrent myocardial infarction, angina, heart failure, stroke).~   "
138914|NCT01749033|"~     A laryngeal mask airway (LMA) is an airway device that is commonly used and placed under~     general anesthesia to facilitate ventilation of the patient's lungs while anesthetized. It is~     similar to an endotracheal tube (a breathing tube) but is less invasive. It is also placed~     as a backup when the Anesthesiologist is unable to pass a breathing tube and the patient is~     not adequately ventilating. Unfortunately, an LMA may lead to complications similar to those~     of breathing tube placement, such as sore throat and hoarse voice. Previous studies have~     examined several variables that may affect how often complications occur; these variables~     include giving anti-inflammatory medications and inflating the LMA to different pressures~     (the working end of the LMA, which rests in the patient's throat, has a cuff that is~     inflated to provide a seal). We are studying the effect of the PLACEMENT TECHNIQUE on~     postoperative sore throat, hoarse voice, and difficulty swallowing. We will be using 3~     placement techniques - the traditional placement technique, a slightly different traditional~     placement technique, and a new technique, abbreviated the ELLIA method. The hypothesis of~     this study is that a new LMA insertion technique will have no difference in postoperative~     pharyngolaryngeal morbidity including sore throat, dysphagia and dysphonia.~   "
138915|NCT01749020|"~     The purpose of the study is to determine the effect of polyphenol-rich dark chocolate on~     insulin sensitivity in normal weight and overweight adults.~   "
138916|NCT01749007|"~     The purpose of this project is to gather pilot data related to exploring relationships~     between cognitive impairment and/or psychiatric distress and suicidal thoughts and/or~     behaviors in Veterans with Human Immunodeficiency Virus (HIV)/Acquired Immune Deficiency~     Syndrome (AIDS). To achieve this goal, a neuropsychological battery will be administered to~     Veterans with HIV/AIDS.~   "
138917|NCT01748994|"~     The body shape of obese women varies between having the majority of fat either above the~     waist (apple shape) or below the waist (pear shape). The study will investigate what~     restricts: apple-shaped women from being pear-shaped at the cellular level. Since pear~     shaped women tend to have better health, this study will open the door to future research in~     regulating body shape and thus improving health.~   "
138918|NCT01748981|"~     The purpose of the study is to investigate the change in pulmonary function and exercise~     capacity in lung cancer patients after pulmonary resection. Furthermore, to study the effect~     of training on aerobic capacity, muscular strength, morbidity and survival. Physical activity~     level by accelerometers, body composition by DXA and quality of life will also be reported.~   "
138919|NCT01748968|"~     The purpose of this project is to gather pilot data related to risk factors associated with~     suicide in Veterans with Human Immunodeficiency Virus (HIV)/ Acquired Immune Deficiency~     Syndrome (AIDS) and to develop an educational and interventional tool and instructional guide~     that can be utilized by local and national providers to increase understanding regarding~     suicide risk assessment. There are no hypotheses associated with this qualitative pilot~     study.~   "
138920|NCT01748955|"~     This study uses functional magnetic resonance imaging (fMRI) to investigate the effects of~     two different antidepressant medications (Paxil CR versus Wellbutrin XL) on reward processing~     in depressed patients who have attempted suicide or are currently experiencing suicidal~     thoughts.~   "
138921|NCT01748942|"~     This randomized pilot clinical trial studies dexamethasone in reducing oral pain and dry~     mouth after surgery in patients with oropharyngeal cancer. Dexamethasone may help lower pain~     and dry mouth caused by surgery.~   "
138922|NCT01748929|"~     Women of reproductive age are considered a high-risk group for worm infections by the World~     Health Organization. Maternal infection and anemia contribute to infant malnutrition by~     affecting milk quality and quantity, and duration of exclusive breastfeeding. To date, no~     study has investigated the health benefits of postpartum deworming to infants or mothers. A~     randomized controlled trial will be conducted in Peru to investigate the effectiveness of~     integrating deworming into routine postpartum care. The primary measure of effect will be~     infant weight gain between birth and six months of age. Other infant and maternal health~     indicators will also be ascertained.~   "
138923|NCT01748916|"~     The goal of this study is to determine if papaya fruits are an exceptionally good food source~     for carotenoids in humans, particularly when compared more common carotenoid sources like~     carrots and tomatoes. This objective will be accomplished by quantitation of the immediate~     post-prandial plasma concentrations of parent carotenoids and vitamin A metabolites from~     subjects who consumed a meal containing fresh papaya, tomato, and carrot.~   "
138924|NCT01748903|"~     The purpose of this prospective registry is to collect real world, post-marketing data on the~     use of Stryker Target® 360,Target® 2D, and 2nd generation Target® Nano coils for the~     embolization of ruptured or unruptured intracranial saccular aneurysms. Up to 300 patients~     (150 in the TARGET 360°/Helical arm and 150 in the New NANO arm) presenting with intracranial~     aneurysms suitable for coil embolization will be enrolled at up to 20 sites. A post hoc~     analysis comparing Target® 360° and Target® 2D coil technical and clinical endpoints will be~     performed.~   "
138925|NCT01748890|"~     Prostate cancer is the most common cancer and the second-leading cause of cancer death~     amongst men in the United States. Sonoelastography is an imaging technology predicated on~     reproducible differences in the backscattered ultrasound signal produced by compression of~     tissues of varying stiffness. It permits measurement of the elastic properties of tissue.~     These measurements can be transposed onto conventional anatomic ultrasound images, producing~     a colorized overlay that allows direct visualization of the anatomic distribution of tissue~     stiffness. In this study, we aim to determine whether prostate biopsies planned with~     sonoelastographic guidance would be more likely than random prostate biopsies to intersect~     with foci of carcinoma in the prostate gland, and to determine whether prostate biopsies~     planned with sonoelastographic guidance would be more likely than random prostate biopsies to~     yield histopathology representative of the final Gleason Score obtained at pathologic~     assessment of the resected prostate.~   "
138926|NCT01748877|"~     The purpose of this study is to investigate whether NXN-462, a selective nNOS inhibitor, is~     effective in reducing pain levels in patients with post-herpetic neuralgia.~   "
138927|NCT01748864|"~     A Phase 1, single-center, open-label, single arm, baseline-controlled (for safety) study in~     normal volunteers. Study will determine biodistribution and excretion of the radioactive drug~     substance and evaluate the safety and tolerability of 99mTC-Etarfolatide in normal~     volunteers.~   "
138930|NCT01748825|"~     BACKGROUND:~        -  Wee1 is a tyrosine kinase involved in the phosphorylation and inactivation of~          cyclin-dependent kinase 1 (CDK1/CDC2)-bound cyclin B, resulting in G2 cell cycle arrest~          in response to DNA damage to allow time for DNA repair. Recent preclinical data~          additionally implicates Wee1 in maintenance of genomic integrity during S phase.~        -  AZD1775 is a selective inhibitor of Wee1 kinase. Recent preclinical model data~          additionally show single agent anti-tumor activity in multiple cancer cell lines and~          tumor xenografts.~        -  Preliminary data show AZD1775 is tolerable at lower doses in combination with~          chemotherapeutic agents. We propose to demonstrate single-agent activity for AZD1775.~      PRIMARY OBJECTIVE:~        -  To establish the safety and tolerability of single-agent AZD1775 in patients with~          refractory solid tumors~        -  To determine the pharmacokinetics of AZD1775 in patients with refractory solid tumors~      SECONDARY OBJECTIVES:~        -  To determine the effect of AZD1775 on markers of DNA damage and apoptosis in tumor~          tissue and circulating tumor cells~        -  To evaluate the antitumor activity of AZD1775 in patients with refractory solid tumors~      EXPLORATORY OBJECTIVES:~      -To identify tumor genomic alterations and gene expression patterns potentially associated~     withAZD1775 antitumor activity~      ELIGIBILITY:~        -  Patients must have histologically confirmed solid tumors for which all standard therapy~          known to prolong survival have failed, or for which standard therapies do not exist.~        -  No major surgery, radiation, or chemotherapy within 3 weeks or (5 half-lives, whichever~          is shorter) prior to entering the study.~        -  Adequate organ function~      STUDY DESIGN:~        -  This study will follow a traditional 3+3 design.~        -  In Arm A starting at dose level 1, AZD1775 will be administered orally, BID, for 5 doses~          (D1-3) during each cycle. Starting at dose level 2 and onwards, AZD1775 will be~          administered orally, BID, for 5 doses for the first 2 weeks of each cycle (D1-3 and 8-~          10). Each cycle is 21 days (+/- 1 day for scheduling).~        -  Once MTD is established, 6 additional patients will be enrolled at the MTD to further~          evaluate that dose for PK and PD endpoints.~        -  A further expansion arm of 6 additional patients with documented tumors harboring BRCA-1~          or -2 mutations will also be enrolled at the MTD to further explore the safety of the~          agent and obtain preliminary evidence of activity in this patient population.~        -  Based on preliminary evidence of drug activity in an alternative once-daily dosing~          schedule, patients without a documented BRCA mutation will be accrued to a once-daily~          dosing schedule Arm B, with mandatory paired tumor biopsies at the maximum tolerated~          single daily dose, to further evaluate PD endpoints. AZD1775 will be administered orally~          once daily for 5 days (D1-5 and 8-12) during weeks 1 and 2 of each 21-day cycle (+/- 1~          day for scheduling).~        -  During the escalation phase, tumor biopsies will be optional and will be evaluated for~          pharmacodynamic (PD) studies for evidence of Wee1 inhibition DNA damage and repair, and~          apoptosis (yH2AX, pNbs1, Rad51, pTyr15-Cdk and caspase 3). During the expansion phase,~          once MTD is reached, mandatory paired tumor biopsies will be pursued in up to 20~          additional patients enrolled at the MTD to further evaluate PD endpoints.~   "
138931|NCT01748812|"~     Background:~        -  Hypophosphatemia is a condition where a person has low levels of phosphorus in the~          blood. Low blood phosphorus can cause muscle and bone weakness (such as rickets) and~          teeth problems. One cause of the condition is having too much fibroblast growth factor~          23 (FGF23). FGF23 is a hormone that causes the kidney to get rid of phosphorus in the~          urine. It can also prevent the body from making vitamin D, which helps the body absorb~          phosphorus in food.~        -  Many people with low blood phosphorus take high doses of phosphorus and calcium~          medications. However, one side effect of these drugs is increased blood levels of~          parathyroid hormone (PTH). The drug cinacalcet can help lower PTH levels, which may~          decrease the amount of phosphorus lost in the urine and increase the phosphorus levels~          in the blood. Researchers want to see if cinacalcet can help blood phosphorus and~          decrease the amount of phosphorus supplements that people need to take.~      Objectives:~      - To see if cinacalcet can be a safe and effective treatment for people with low phosphorus~     conditions due to high FGF23.~      Eligibility:~      - Individuals between 18 and 70 years of age who have different forms of hypophosphatemic~     rickets and tumor-induced hypophosphatemia~      Design:~        -  Participants will have up to 25 study visits over about 28 weeks.~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected.~        -  Up to three more lab visits for blood and urine tests will be required before treatment.~          Imaging studies of the bones, spine, and kidneys will be performed.~        -  Participants will have a 3-night hospital stay to start treatment. They will take~          cinacalcet once a day. Treatment will be monitored with frequent blood tests and imaging~          studies.~        -  Participants will continue to take cinacalcet once a day for 3 weeks. They will have~          regular study visits to monitor the treatment.~        -  There will be up to two other overnight hospital stays (1 to 3 nights) to adjust~          cinacalcet doses. The dose will increase until the maximum dose is reached, or side~          effects develop.~        -  After the end of the cinacalcet study, participants will have several more followup~          visits to monitor the effects of treatment.~   "
138932|NCT01748799|"~     The purpose of this study is to to demonstrate the feasibility and tolerability of the use of~     Sativex in cannabis dependent individuals and to assess the effects of fixed or self titrated~     dosages of SATIVEX® (Δ9-tetrahydrocannabinol /cannabidiol combination in a buccal spray) on~     withdrawal symptoms, craving scores and cannabis consumption during the study period.~   "
138933|NCT01748786|"~     The purpose of this study is to compare an online 12-module intervention designed to improve~     emotion regulation and social relations via mindfulness training with a 12-module program~     that provides information about health behaviors to individuals with fibromyalgia. The~     mindfulness training program is expected to produce greater day-to-day improvements than the~     education condition in individuals' efficacy for coping with pain and stress, positive and~     negative affect, and positive engagement in social relations assessed via online diaries~     completed each evening during the intervention period.~   "
138934|NCT01748773|"~     This single-arm, open-label study will evaluate the safety and efficacy of the combination~     oxaliplatin, capecitabine, and trastuzumab with chemoradiotherapy in the adjuvant setting in~     participants with curatively resected HER2+ gastric or gastroesophageal junction cancer.~     Participants will receive trastuzumab 8 milligrams per kilogram (mg/kg) intravenously (IV) on~     Day 1 of Cycle 1 and 6 mg/kg IV on Day 1 of every following 3-week cycle, with oxaliplatin~     100 milligrams per square meter (mg/m^2) IV on Day 1 of Cycles 1-3, and capecitabine 850~     mg/m^2 orally twice daily on Days 1-14 of Cycles 1-3 and on 5 days per week during~     chemoradiotherapy. Radiotherapy will be given at a total dose of 45 gray (Gy) divided into 25~     doses on 5 treatment days each week for 5 weeks starting Day 22 of Cycle 3. Anticipated time~     on study treatment is 1 year plus a 1-year follow-up period.~   "
138935|NCT01748760|"~     This study is to develop an adjunctive intervention for acutely suicidal adolescents who have~     been admitted to a psychiatric inpatient unit. The study intervention is comprised of: 1) two~     to three individual sessions delivered in an inpatient setting or immediately upon discharge;~     2) one family session; 3) six months of follow-up phone interventions. The investigators~     hypothesize that those who receive the study intervention will have lower rates of suicide~     events and greater decreases in suicidal ideation after six months.~   "
138936|NCT01748747|"~     This pilot clinical trial studies vaccine therapy and resiquimod in treating patients with~     stage II-IV melanoma that has been removed by surgery. Vaccines made from peptides may help~     the body build an effective immune response to kill tumor cell tumor cells. Biological~     therapies, such as resiquimod, may stimulate the immune system in different ways and stop~     tumor cells from growing. It is not yet known whether Gag:267-274 peptide vaccine and~     resiquimod are more effective when given together or separately~   "
138937|NCT01748734|"~     The purpose of this study is to learn about treatment of depression in people who have any~     type of cancer. Cognitive therapy (CT) helps improve depressive symptoms by targeting~     patient's thoughts and behaviors. People who are depressed tend to have more negative or~     pessimistic thoughts. CT helps people evaluate the accuracy of their thoughts. By encouraging~     patients to develop more balanced views, symptoms of depression begin to improve~   "
138938|NCT01748721|"~     This phase I trial studies the side effects and best dose of MORAb-004 in treating young~     patients with recurrent or refractory solid tumors or lymphoma. Monoclonal antibodies, such~     as MORAb-004, can block cancer growth in different ways. Some block the ability of cancer to~     grow and spread. Others find cancer cells and help kill them or carry cancer-killing~     substances to them~   "
138986|NCT01748097|"~     The investigators use bicarbonate injected to an intravenous line and the changes in the~     exhaled end-tidal carbon dioxide to verify whether the IV line is in the vein or surrounding~     tissue~   "
138939|NCT01748708|"~     Electroconvulsive therapy (ECT) has unparalleled efficacy in treating severe depression that~     is resistant to common modalities of treatment, such as antidepressant medication. Although~     treatment with ECT has benefited many individuals with treatment resistant depression (rates~     as high as 50-75%), its more widespread use is hindered by the social stigma associated with~     the treatment, as well as by its significant cognitive side effects. Moreover, ECT cannot be~     precisely targeted, since it produces a widespread activation of the brain surface, in turn,~     affecting many different functional areas. Magnetic seizure therapy (MST) is currently being~     investigated as an alternative to ECT, as it is more focused to one area of the brain. Rather~     than applying electrical stimuli to induce a seizure, as is done in ECT, MST uses repetitive~     magnetic stimulation to produce the seizure. Preliminary research suggests that MST can~     result in therapeutic effects comparable to those produced by ECT, but without the negative~     side effects on cognition. The proposed study is a randomized, controlled trial, in which the~     efficacy and side effect profile of MST will be compared to those of ECT. If successful, the~     results of this study may lead to increased treatment availability and accessibility, as well~     as lessen the substantial health care costs associated with treatment resistant depression.~   "
138940|NCT01748695|"~     The purpose of this study is to investigate whether V158866 is safe and effective for the~     treatment of neuropathic pain due to spinal cord injury.~   "
138941|NCT01748682|"~     Despite the relative consensus on the benefits of pre-surgical weight loss, i.e., the~     reduction of comorbidities associated with surgical act, such as decreased visceral fat,~     liver volume, hemorrhage perioperative and surgical time, the characteristics of the diet to~     be employed in this period need to be defined more clearly. As there is no description of~     comparative studies on diet of normal consistency, using solids and liquids, there are doubts~     as to the real need for consistency liquid diet in preoperative bariatric surgery. The lack~     of robust evidence has made nutrition professionals adopt different procedures. There is~     still a belief that these patients are unable to lose weight in the preoperative period, the~     ongoing history of previous attempts without success.~   "
138942|NCT01748669|"~     Twenty patients of mild to moderate degree of arsenical palmer keratosis will be treated with~     garlic oil capsule orally for 12 weeks to examine its effectiveness in reducing body arsenic~     load and clinical symptoms. Similar treatment with similar number of arsenic exposed controls~     and healthy volunteers will be included for comparison.~   "
138943|NCT01748656|"~     Patients with OHS are efficiently managed with long term home-based nocturnal noninvasive~     positive pressure ventilation (NIPPV). Several NIPPV devices offer the feature of~     automatically adjusting pressure support (and/or respiratory back-up rate) on the basis of a~     pre-determined ideal tidal volume or ideal ventilation. However algorithms used to~     achieve these ideal targets are different among different commercialized devices and the~     relative efficacy from an algorithm compared to another remains unknown. The main objective~     is this study is to compare two commercialized NIPPV that have this option~   "
138944|NCT01748643|"~     The purpose of this study is to investigate if a deep neuromuscular block with a continuous~     infusion of rocuronium titrated to a post-tetanic count (PTC) of 1-2 responses combined with~     reversal of neuromuscular blockade with sugammadex results in improved surgical conditions~     for the surgeon and/or improved post-operative respiratory function for the patients as~     compared to a standard technique with an intubation dose of rocuronium and top-ups as needed~     to maintain a neuromuscular blockade with a train of four (TOF) count of 1-2 and reversal of~     neuromuscular blockade with neostigmine/glycopyrrolate.~      Furthermore, we want to investigate the effect of pneumoperitoneum, and NMB with rocuronium~     and reversal with sugammadex or neostigmine/glycopyrrolate on cerebral tissue oxygenation.~   "
138945|NCT01748630|"~     Background: The study aim was to compare the efficacy of dexmedetomidine versus midazolam for~     sedation during the early postoperative period in children who underwent scoliosis surgery.~      Methods: We performed a prospective, randomized trial in an intensive care unit (ICU) in a~     tertiary care center. In this study, 42 patients (American Society of Anesthesiology physical~     status I and II) who underwent scoliosis surgery were divided into 2 groups according to~     sedation protocols: group DEX (n = 22) and group MDZ (n = 20). Children (12-18 years)~     requiring mechanical ventilation underwent a continuous infusion of either dexmedetomidine~     (group DEX; starting dose, 0.4 μg•kg-1•h-1) or midazolam (group MDZ; starting dose, 0.1~     mg•kg-1•h-1) with intermittent fentanyl, as needed. The efficacy of sedation was assessed~     using the Richmond Agitation Sedation Scale (RASS). Quality of pain relief was measured using~     the Numeric Visual Analog Scale (NVAS). During the arousal assessment, delirium was~     determined in patients in the RASS range of -2 to +1 using the Confusion Assessment Method~     for the ICU (CAM-ICU). Fentanyl consumption, incidence of delirium, NVAS scores, and~     hemodynamics were recorded postoperatively at 2, 4, 6, and 24 h in the ICU.~   "
138946|NCT01748617|"~     This study will be a randomized, double-blind, crossover intervention to investigate the~     health effects of acute ingestion of pomegranate juice when consumed with a high fat meal.~     After one week of controlled dietary intervention, subjects will consume a high fat morning~     meal supplemented with either pomegranate juice or a juice-free sweetened beverage. After~     consumption of the breakfast meal, subjects will be assessed for endothelial function and~     postprandial meal response.~   "
138947|NCT01748604|"~     The purpose of this multicenter randomised controlled study is to determine whether manual~     lymphatic drainage (MLD) brings any benefit when added to intermittent pneumatic compression~     (IPC) plus multilayer, multicomponent bandages (MB) in the decongestive lymphatic therapy~     (DLT) in patients with lymphedema~   "
138948|NCT01748591|"~     A Confirmation of Safety, Tolerance and Efficacy of PICOPREP in Clinical Practice.~   "
138949|NCT01748578|"~     This is a First-In-Human (FIH) study to assess the safety and tolerability of ocular~     administration of EBI-005 in healthy volunteers. Additionally, the PK and immunogenicity of~     EBI-005 will be assessed.~   "
138950|NCT01748565|"~     The purpose of this study is to identify biological markers that might predict premature~     infants who are at a higher risk for developing BPD, and to correlate the presence of these~     markers with infant symptoms and lung function in the first year after discharge from the~     hospital.~   "
138987|NCT01748084|"~     The purpose of this study is to determine whether rituximab is effective in the treatment of~     articular symptoms that occur in systemic sclerosis related polyarthritis~   "
138951|NCT01748552|"~     The aim of this trial is to evaluate the safety of the study drug in healthy participants and~     participants with diabetes. It will investigate how much of the study drug gets into the~     blood stream and how long it takes the body to get rid of it. Information about any side~     effects that may occur will also be collected.~      The study consists of two parts. Part A will study healthy participants in up to 3 dosing~     periods over approximately 6 weeks. Part B will study participants with diabetes in up to 3~     dosing periods over approximately 6 weeks.~   "
138952|NCT01748539|"~     This study is designed to evaluate the efficacy and safety of KHK4827 in subjects with~     moderate to severe plaque psoriasis in a randomized, double-blind, placebo-controlled,~     parallel group study. Pharmacokinetics of KHK4827 will also be assessed.~   "
138953|NCT01748526|"~     The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the~     drug) and pharmacodynamics (ie, how the drug affects the body) of 2 different doses of~     canagliflozin (JNJ-28431754) in healthy Indian volunteers.~   "
138954|NCT01748513|"~     Preoperative venous return stability and euvolemia is essential in management of morbidly~     obese patients. Fluid therapy regimes for patients with high BMI, especially with focus on~     preoperative management, are rare and not in consensus.The aim of this study was to evaluate~     preoperative effects of a standardized, ideal body weight (IBW) based volume-challenge on~     hemodynamics, stroke volume and level of venous return to the heart.~   "
138955|NCT01748500|"~     The main objectives of this trial are:~        1. To assess the activity and safety of pantoprazole and docetaxel (with prednisone) in men~          with metastatic CRPC who have not received prior chemotherapy.~        2. To evaluate archival prostate cancer tissue of men included in the clinical trial for~          evidence of autophagy using IHC for LC3B, ATG5, p62 as well as ERG.~        3. To evaluate pharmacokinetic interactions of pantoprazole with docetaxel.~   "
138956|NCT01748487|"~     The purpose of this study is to assess the efficacy and safety of OZURDEX (dexamethasone~     intravitreal implant) 0.7 mg administered immediately after phacoemulsification and~     intraocular lens implantation in type 1 or 2 diabetic patients to prevent the occurrence of~     post-surgical macular edema (ME).~      Treatment group: 24 patients will receive an intravitreal injection of OZURDEX at the end of~     cataract surgery Patients will be seen at 1 week pre-operatively (baseline visit), and on the~     same day post-surgery (visit 1), at 1 week (visit 2), 1 month (visit 3) and 3 months (visit~     4).~      BCVA, IOP and SD-OCT will be performed at each visit.~   "
138957|NCT01748474|"~     In a randomized, sham-controlled trial the investigators will test whether supplemental~     oxygen given during cardiopulmonary exercise testing will improve exercise performance and~     physiological parameters in patients with pulmonary arterial or chronic thromboembolic~     pulmonary hypertension.~   "
138958|NCT01748461|"~     The purpose of the present study is to evaluate the short-term and long-term effects of a~     cycle ergometer program on physical activity and physical fitness in elderly (65+).~     Therefore, physical activity, physical fitness and functionality are measured at baseline,~     after 10 weeks (after the intervention period), after 6 months and after 1 year.~      Different coaching techniques (to promote the use of a cycle ergometer and cycle ergometer~     program) will also be evaluated. What is the best (coaching) approach for long-term adherence~     (physical activity)?~   "
138959|NCT01748448|"~     To assess whether vitamin D supplementation after surgery of a first cutaneous malignant~     melanoma protects against relapse of the disease.~   "
138960|NCT01748435|"~     Neuropathic (nerve pain) following amputation of a limb is very common, affecting 60-80% of~     patients (Sherman et al, 1984). It can prolong their recovery making it difficult to fit~     protheses and mobilise. Current treatment options are limited and existing painkillers have~     significant side effects. Nevertheless there is some evidence that pre-emptive analgesia~     (pain relief provided prior to the surgery) has additional benefits after the surgery~     (Ypsilantis & Tang, 2010) Qutenza (topical capsaicin 8%)is a novel analgesic agent which is~     applied directly onto the skin. It works by desensitising to pain receptors in the skin~     (Nolano et al., 1999) and has been shown to be effective in reducing neuropathic pain in~     other conditions (Backonja et al., 2008) We propose to evaluate the use of Qutenza for~     pre-emptive analgesia in patients undergoing amputation of a limb. This is a small, pilot,~     randomised controlled study of 30 patients undergoing lower limb amputation who will have~     Qutenza or active control applied prior to surgery. They will be followed up for 12 weeks~     post-operatively with regular assessment of pain scores, quality of life and wound healing.~   "
138961|NCT01748422|"~     Arteriovenous fistulae are artificial connections between the artery and vein in the arm~     which allow needles to be inserted for haemodialysising patients wit kidney failure.~     Occasionally severe debilitating pain can arise from these fistulae for which no cause can be~     found. Such pain can be very difficult to treat. Many commonly used used painkillers are~     known to cause significant side effects in patients with renal failure (drowsiness, confusion~     etc.~      Qutenza (topical capsaicin 8%) is a new treatment made from chilli peppers which is applied~     to the skin as a patch and works directly at the nerve endings in the skin to prevent pain.~     It therefore should not have the systemic side effects of other drugs. It has been~     demonstrated to be beneficial in other painful conditions for example post-shingles pain and~     nerve pain from HIV. It has never been used for critical ischaemia before.~      We propose to investigate the efficacy of Qutenza in treating patients with end stage renal~     failure and chronic pain from their fistulae (AVF). We will recruit 20 patients with painful~     AVF and treat them with Qutenza. We will follow them up for 12 weeks and monitor the change~     in their pain scores.~   "
138962|NCT01748409|"~     The aim of the study is to evaluate the autonomic failure in Parkinson's disease by clinical,~     electrophysiological and neuropathological examination.~   "
138963|NCT01748396|"~     Chronic kidney disease (CKD) is an established risk factor for cardiovascular morbidity and~     mortality, as shown by common manifestations of left ventricular hypertrophy (LVH) and~     arterial calcifications in CKD patients. Fibroblast growth factor-23(FGF-23) is a recently~     identified phosphaturic hormone that has been reported to be associated with the development~     of secondary hyperparathyroidism, cardiovascular morbidity, mortality, CKD progression.~      While vitamin D is the mainstay therapy in CKD mineral bone disease (CKD-MBD), increased~     FGF-23 levels have been reported with vitamin D administration. The purpose of this study was~     to investigate the effect of calcium carbonate when used in conjunction with calcitriol on~     FGF-23.~   "
138965|NCT01748370|"~     Low total testosterone (TT) is present in about 30% of men aged >60 years and in up to 7% of~     younger men. Male hypogonadism is associated with metabolic and cardiovascular diseases as~     well as with increased mortality. There is evidence showing a relationship of TT with vitamin~     D in men. We aim at evaluating the effect of vitamin D supplementation on TT and metabolic~     parameters in hypogonadal men. We will study the effects of 20,000 IU vitamin D weekly in a~     12 wk randomized, double-blind, placebo-controlled trial in 100 men with TT <3.0 ng/ml and~     25-hydroxyvitamin D (25(OH)D) <30 ng/ml (patients) as well as in 100 men with TT ≥3.0 ng/ml~     and 25(OH)D <30 ng/ml (controls). Vitamin D supplementation might be a safe therapeutic~     approach improving TT levels as well as metabolic parameters in hypogonadal men. Further the~     effects of vitamin D on androgens will be evaluated in eugonadal men.~   "
138966|NCT01748357|"~     Tuberculosis is a bacterial infection causing 1.1 million deaths annually worldwide.~     Diagnosis of the disease is often time consuming or challenging. Many cases of tuberculosis~     require advanced and expensive diagnostic methods that restrict their availability in~     resource limited countries where the burden of tuberculosis is highest. The development of~     rapid point of care diagnostics is required.~      Published data confirm that trained African giant-pouched rats are able to identify M.~     tuberculosis cultures through olfactory recognition. A first trial using an electronic nose~     reported a rate of detection of 85% in tuberculosis patients. A further trial was closed in~     June 2011 but remains unpublished, yet. The olfactory pattern that potentially allows the~     recognition of tuberculosis remains unknown.~      This trial aims to detect first patterns of volatile organic compounds (VOCs) that bear a~     potential for further development and fine tuning. A technical prototypic device of Siemens~     is used for pattern detection.~      The study is comparing 3 groups of patients:~        -  patients with confirmed active pulmonary tuberculosis (n=20)~        -  patients with other inflammatory lung diseases (pneumonia, sarcoidosis, COPD, bronchial~          carcinoma) (n=20)~        -  healthy volunteers that do not work in the hospital or visit the hospital regularly~          Detailed data for all study subjects will be collected for this trial in order to~          eliminate confounding factors. Furthermore, detailed data of the surroundings of the~          patient, the surroundings of the technical device and of the operator will be captured.~      Hypothesis:~      The pattern of exhaled volatile organic compounds allows the detection of pulmonary~     tuberculosis~   "
138967|NCT01748344|"~     The purpose of this study is to investigate if ONO-4053 relieves symptoms of allergic~     rhinitis in seasonal allergic rhinitis subjects exposed to pollen under controlled~     conditions.~   "
138968|NCT01748331|"~     The purpose of this study is to determine the effect of fluid restriction and the~     neurohormonal mechanisms in the development of hyponatremia in patients with congestive heart~     failure and hyponatremia. The hypothesis is that strict fluid restriction leads to a larger~     increase in plasma sodium than standard treatment in patients with decompensated heart~     failure associated with hyponatremia. A secondary hypothesis is that the neurohormonal change~     is greater in patients treated with strict fluid restriction versus standard treatment.~   "
138969|NCT01748318|"~     In a time of emerging bacteria that are resistant to antibiotics, honey offers an alternative~     that has potential to reduce the heavy reliance on pharmaceutical antibiotics. We will be~     evaluating the effectiveness of a locally produced New Mexico Honey against the standard of~     care Bactrim antibiotic on Community Acquired MRSA.~   "
138970|NCT01748305|"~     Patients with newly diagnosed gestational diabetes will be recruited. The control group with~     get routine diet and exercise counseling. The intervention group will be instructed to get~     moderate-to-vigorous intensity exercise; they will walk on a treadmill one time with~     supervision in order to be instructed how hard to work. All participants will keep an~     exercise log for 3 weeks and will wear an accelerometer for 1 week. The primary outcome is~     glucose control, specifically the need for medication in treatment of their diabetes. The~     hypothesis is that moderate or greater intensity exercise will better control glucose and~     lead to less need for medication management.~   "
138971|NCT01748292|"~     TREX is a phase IIIb, multicenter, randomized, controlled clinical study. Subjects will be~     randomized 1:2 to monthly (control arm) or treat and extend protocol (comparator arm)~     respectively. TREX assess the safety, tolerability and efficacy of intravitreal injections~     (IVT) of 0.5mg ranibizumab given monthly for up to 100 weeks followed by pro re nata (PRN)~     treatment for 56 weeks compared to a Treat and Extend protocol for 156 weeks in patients with~     wet age-related macular degeneration (AMD). Subjects treated in a treat and extend protocol~     receive 3 consecutive IVT 0.5 mg ranibizumab (visits 2, 4 and 5). Starting at week 8, if a~     subject has achieved a dry macula; signs of active exudation have resolved will begin a~     Treat and Extend protocol (visits lengthened by 2 week intervals every visit a dry macular is~     maintained). At the beginning of the 104-week endpoint subjects initially randomized to the~     TREX cohort will transition to PRN re-treatment when there is no exudative disease activity~     at the 12-week interval.~   "
138972|NCT01748279|"~     Rationale: Retrospective studies suggest that statins improve outcomes in COPD patients~     possibly as a result of an anti-inflammatory effect.~      Objectives: To determine whether statins have an anti-inflammatory effect on the lungs of~     patients with COPD.~      A controlled, parallel group study to compare the effects of Atorvastatin in comparison to~     placebo as an add-on treatment to Formoterol therapy in patients with mild to moderate COPD~     in group of 20 patients. All subjects will have spirometry, lung volumes, DLCO, SGRQ, 6MWD,~     serum lipids and hs-CRP measured before and after treatment. Bronchoscopy and transbronchial~     lung biopsy (TBB) will be carried out at baseline and after 12 weeks of treatment, and TBB~     specimens will be processed for histology, immunohistochemistry and microarray analysis.~   "
138973|NCT01748266|"~     Microcirculatory disturbances following cardiac surgery with cardiopulmonary bypass (CPB)~     have been thought to be at the origin of organ dysfunction. Though, few studies correlated~     microvascular alterations with outcome. Investigators aimed at firstly describing~     microcirculation with near infra red spectroscopy (NIRS) and secondly correlating NIRS~     parameters with intensive care length of stay and organ dysfunction.~   "
138974|NCT01748253|"~     Evaluation of 24-hour antihypertensive effect of long-acting ARB-CCB tablet administrated to~     hypertensive patients with atrial fibrillation, and comparison of 24-hour antihypertensive~     effect of long-acting ARB-CCB tablet between morning administration and bedtime~     administration.~   "
138999|NCT01747928|"~     Usability testing of the dual-chambered syringe in conjunction with the proposed patient~     instructions for use.~   "
138975|NCT01748240|"~     Azacytidine (AZA) is the current standard of care for frontline patient treated with~     high-risk MDS and is clinically active in all type of MDS, however, 50% of the patients will~     never respond. Vorinostat is an orally available HDAC inhibitor with clinical activity in MDS~     and proven in vitro synergy with AZA. Patient treated upfront with a combination of this~     agents have shown more responses based on phase I/II data. In the present study, we will use~     the combination of these two drugs to try to create a synergetic effect and generate a~     response for patients who experienced treatment failure after AZA.~      All eligible patients will be treated with Azacitidine and oral vorinostat for 6 cycles of 28~     days. Study Design~   "
138976|NCT01748227|"~     The overall purpose of this pilot study is to conduct a formative evaluation of (veteran)peer~     delivery of a chronic pain self-management program to veterans with chronic musculoskeletal~     pain.~      Our specific aims are as follows:~      Aim 1: Evaluate the feasibility of identifying, recruiting, training, and retaining veteran~     peers to implement a self-management program for chronic pain.~      Aim 2: Identify facilitators and barriers to peer-delivery of a chronic pain self-management~     program.~      Aim 3: Convene an expert panel to review the results of Aims 1 and 2, help to interpret the~     results, and plan next steps.~   "
138977|NCT01748214|"~     Infants in neonatal intensive care units are increasing exposed to non-invasive ventilatory~     support modes (nasal continuous positive airway pressure - NCPAP and high flow nasal cannula:~     >1 L/min flow - HFNC). While there have been small descriptive studies of noise exposure in~     infants on NCPAP, there have been no comparative trials done comparing noise exposure in~     infants undergoing both NCPAP and HFNC.~      Objective: Using a cross-over model determine noise exposure levels in infants exposed to~     similar levels of respiratory support provided by NCPAP and HFNC.~   "
138978|NCT01748201|"~     Hemophilia is a recessive X chromosome linked genetic disorder of blood coagulation that~     affects about one in every ten thousand people. Hemarthrosis, which you can begin in~     childhood, promptly leads to degenerative changes of the articular cartilage which culminate~     in deformity and degenerative changes early, known as hemophilic arthropathy, which is the~     most common complication of hemophilia. Aside administration of clotting factor, treatment~     should address the degenerative changes already present in patients joints. Our objective is~     to evaluate the effectiveness of articular washing followed by infiltration with~     corticosteroids and hylan G-F 20, followed by a program of home exercises and/or academy as~     the previous level of hemophilia patients, in relation to pain relief, and improved function~     and quality of life.~   "
138979|NCT01748188|"~     The purpose of this study is to determine whether dexketoprofen administered by phonophoresis~     or iontophoresis is more effective in the treatment of subacromial syndrome that the~     conventional therapy with ultrasounds.~   "
138980|NCT01748175|"~     The Severe Asthma Research Program III is an NIH cooperative agreement involving 7 clinical~     centers that encompass a multidisciplinary partnerships between asthma clinician-scientists~     and scientists with expertise in immunology, pulmonary physiology, molecular genetics,~     molecular phenotyping, imaging, and bioinformatics. These clinical centers will jointly~     recruit volunteers with asthma for an observational longitudinal follow-up study. However,~     centers will also conduct specific mechanistic research projects at each participating~     institution. The University of Pittsburgh's SARP III study will determine the molecular and~     clinical stability of asthma phenotypes over time.~   "
138981|NCT01748162|"~     Presently children who experience recurring croup symptoms receive a variety of treatments.~     This is because it is not clear which treatments may be best. Some children are given inhaled~     steroids (similar to what children with asthma use). Others are carefully watched and~     cautioned to avoid potential triggers (certain foods, environmental allergens, etc), and~     should episodes of croup recur they are treated with a short course of oral steroids. The~     purpose of this study is to compare two safe and clinically appropriate methods for treating~     recurrent croup, daily inhaled steroids versus observation with oral steroids on an as needed~     basis, to see if either is useful in preventing future episodes of croup.~   "
138982|NCT01748149|"~     This is a multicenter, safety and pharmacokinetic trial to determine the MTD and/or select a~     recommended phase 2 dose (RP2D) of vemurafenib in children with recurrent or refractory~     gliomas containing the BRAFV600E or BRAF Ins T mutation.~   "
138983|NCT01748136|"~     That computed tomography (CT) screening of HIV-seropositive heavy smokers will detect early~     stage lung cancer at significantly higher rates than what is currently being observed.~   "
138984|NCT01748123|"~     -  Clinical equipoise exists with respect to the important question, What is the best~          initial diuretic for the treatment of Hypertension? A pragmatic comparative~          effectiveness research (CER) study comparing Chlorthalidone to Hydrochlorthiazide (HCTZ)~          could help inform decision making for this common problem.~        -  The investigators aim to harness both the power of bioinformatics (using web-based~          data-capture and electronic health records) and of online media (through collaboration)~          in order to facilitate such a CER in usual-care settings. This process may also~          provide a foundation for testing a wealth of important clinical questions which commonly~          arise in the delivery of contemporary healthcare and would otherwise be left unanswered.~        -  To this end the investigators are developing a website, EBMtrialcentral, where eligible~          physicians can go online and join their collaborative network. Physicians can then~          enroll eligible patients in this study. These will include under-served urban patients.~          Clinical information will be entered online (using a secure database housed at Johns~          Hopkins), patient consent will be obtained electronically and treatment recommendations~          will be randomly allocated to either 25mg daily of oral HCTZ or 12.5mg daily of oral~          Chlorthalidone. The investigators aim to increase to 50mg HCTZ and 25mg Chlorthalidone~          over 8 weeks and compare their effects on BP measured with a 24 hour monitor.~        -  The investigators' primary hypothesis is that non-blinded, random, parallel allocation~          of 12.5mg daily Chlorthalidone (titrated to 25mg at 4 weeks) will demonstrate a~          clinically meaningful ≥5mmHg improvement in BP control (as measured by change in BP from~          baseline using 24hr ABPM) compared to 25mg daily HCTZ (titrated to 50mg at 4 weeks) in~          newly hypertensive patients followed in a usual-care clinic setting over 8 weeks. They~          will also analyze differences in side-effects or safety (serum electrolytes) between~          these two medications.~   "
138985|NCT01748110|"~     The goal of the study is to assess the impact of a health intervention, involving both diet~     and exercise modification, on outcomes following radical prostatectomy for the treatment of~     clinically localized prostate cancer. The specific urological outcomes expected to be~     improved are accelerated and/or improved recovery of erectile function (EF), as well as~     urinary continence, both very commonly affected by this surgery. Furthermore, as demonstrated~     by changes in responses to various questionnaires, an improvement in overall health-related~     quality of life is expected. Finally, an improvement in patients participating in the~     intervention groups in physical parameters, including body mass index (BMI), blood pressure~     (BP), and metabolic parameters, including serum glucose and cholesterol levels, is expected.~   "
138988|NCT01748071|"~     Purpose: This study aimed to find a quick and timely way to investigate the individual~     variation of efficacy of opioid analgesic in Chinese patients undergoing elective surgeries.~     Methods: 120 female patients receiving elective surgery under general anesthesia were~     recruited into this study. At the time of routine intravenous anesthetic induction we observe~     the efficacy of opioid analgesic including analgesic effect, effects on Narco-trend index,~     sedative effect, effects on respiratory system, and aslo effects on cardiovascular system.~   "
138989|NCT01748058|"~     The aim of this study is to evaluate the efficacy and feasibility of active video gaming with~     regard to the promotion of physical activity and motor learning in children with cancer.~     Experienced fatigue, body mass index and the development of metabolic risk factors during~     treatment are also examined.~   "
138990|NCT01748045|"~     The aim of this study is to determine if inhaled nitric oxide will improve short and long~     term respiratory outcomes in preterm infants. Infants born at a gestational age of 30-36~     weeks and who require breathing support with high flow nasal cannula, nasal continuous~     positive airway pressure, or nasal intermittent positive pressure will be randomized to~     receive either inhaled nitric oxide or placebo. The dose will then be decreased per protocol~     until all respiratory support has been discontinued. Infants will be followed to evaluate~     safety and efficacy of non-invasive iNO delivery, up to 12 months corrected gestational age.~   "
138991|NCT01748032|"~     The purpose of this study is to examine the effects of the alternative uses training (AUT)~     and word association training (WAT) on cognitive functions and mood symptoms in late-life~     depression (LLD).~      The hypotheses are:~        1. post-training cognitive performance will be superior to pre-training cognitive~          performance~        2. post-training depressive symptomatology will be less severe as compared with~          pre-training clinical severity and~        3. AUT group will show better post-training cognitive performance and improved mood~          symptoms when compared with the WAT group.~   "
138992|NCT01748019|"~     ST1968 is a novel camptothecin derivative which interacts with topoisomerase I-DNA complex,~     inducing S-Phase specific cytotoxicity. It is endowed with a potent antitumor activity and an~     increased Therapeutic Index with respect to the clinically used analogues (i.e.irinotecan and~     topotecan) in some xenograft models (ovary, colon, head & neck, cervix). Anti-tumor activity~     has been also noted in platinum resistant ovarian cell xenografts and in topoisomerase I~     mutant prostate cell lines. The acceptable toxicity profile in animals and the activity in~     camptothecin-resistant cell lines make ST1968 a good candidate for clinical trials.~   "
138993|NCT01748006|"~     The relationship between the activation of the vasopressin system and central hemodynamics in~     heart failure (including right and left heart filling pressures and cardiac output) is not~     clear. The investigators intend to examine the correlation between levels of copeptin and~     vasopressin and the central hemodynamic system in patients with advanced (class III or IV)~     heart failure. The investigators also aim to examine the relationship of selected cardiac~     biomarkers in blood and urine with cardiac filling pressures and cardiac output in patients~     with decompensated heart failure.~      The study population will consist of 30 patients admitted to the Department of Cardiology at~     Copenhagen University Hospital. Only patients for whom the attending cardiologist has already~     decided upon right heart catheterization for clinical/treatment reasons will be recruited for~     the study.~   "
138994|NCT01747993|"~     Catheter-associated urinary infections are the most common hospital-acquired infections and~     can be prevented by early catheter removal. This study evaluates tamsulosin to reduce the~     failure of early catheter removal has been studied in elderly women hospitalized for an acute~     condition and experiencing acute urinary retention: 448 women 75-year old or more without an~     anatomical or neurological cause of urinary retention will be randomized to a 6 days course~     of tamsulosin 0.4 mg or placebo. Catheter removal will be attempted after the third dose of~     tamsulosin and the need to replace another catheter within 72 hours will define a failed~     attempt.~   "
138995|NCT01747980|"~     Absorption of therapeutic proteins taken orally has remained the major hurdle for treatment~     in humans. The proteins are generally degraded by enzymes in the stomach and intestine and~     the intestine lining that prevents absorption into the circulation. Administration of~     PRX-112, a plant recombinant human glucocerebrosidase (prGCD) using plant cells as carrier~     vehicle, may help overcome many of these hurdles. The plant cell wall protects the protein~     from degradation in its transport through the upper GI and allows release in the lower~     intestine. Studies in animals have shown that prGCD delivered in this way can be found in the~     blood stream in an active form.~   "
138996|NCT01747967|"~     There is currently no imaging technique allowing to directly visualize and measure pancreatic~     beta-cell mass. Consequently, the best parameter to estimate this mass is the insulin (and~     its C-peptide byproduct) that residual beta cells are able to produce. This insulin secretion~     is measured during a meal test, before and at different times after drinking a standardized~     quantity of nutrients. However, this test is cumbersome (lasting 3 h, with blood samples~     taken every 30 minutes) and it holds poor sensitivity, probably insufficient to detect very~     few residual beta cells. Nevertheless, these few residual cells can improve glycemic control~     and can be instrumental for the clinical efficacy of immune and/or regenerative therapies.~      We hypothesize that residual beta cells may not only represent the remaining insulin~     secretory capacity, but also the antigenic load capable of stimulating beta-cell-reactive T~     lymphocytes. The disappearance of these T lymphocytes from circulating blood over time may~     thus be correlated with beta-cell loss. Measuring beta-cell-reactive T-cell responses may~     therefore provide simple and sensitive immune surrogate markers of residual insulin~     secretion. Other surrogate markers may be obtained by measuring urinary C peptide or residual~     secretion of the counter-regulatory hormone glucagon.~      The main objectives of this study are:~        1. To evaluate the correlation between beta-cell-reactive T-cell responses and residual~          insulin secretion.~        2. To evaluate the correlation between the residual insulin secretion measured by serum C~          peptide and by urinary C peptide.~        3. To evaluate the correlation between the residual insulin and glucagon secretion.~   "
138997|NCT01747954|"~     The hypothesis of this study is that respiratory physiotherapy can promote improvement in~     respiratory mechanics in children with respiratory failure and the bag squeezing maneuver is~     more effective in improving respiratory mechanics in childrens and does not alter the~     hemodynamic proved safe~   "
138998|NCT01747941|"~     The study is designed to test safety tolerability and PK of single oral ascending doses of~     PF-06305591,~   "
139000|NCT01747915|"~     The study is designed to evaluate the safety, tolerability and efficacy of two doses of~     pregabalin as add-on treatment in pediatric and adult subjects with Primary Generalized~     Tonic-Clonic (PGTC) seizures as compared to placebo. It is hypothesized that both doses of~     pregabalin will demonstrated superior efficacy when compared to placebo by reducing PGTC~     seizure frequency and that pregabalin will be safe and well tolerated.~   "
139001|NCT01747902|"~     The long head of biceps brachii tendon has been known to be a pain generator and a common~     cause of shoulder pain and dysfunction in patients with rotator cuff pathology. Both biceps~     tenotomy and tenodesis have been shown to produce comparable results, but there is no~     consensus to date due to a lack of level I evidence. The aim of this prospective, randomized,~     clinical trial is to compare subjective patient-reported outcomes and objective clinical~     results between biceps tenotomy and biceps tenodesis for treating lesions of the long head of~     the biceps brachii.~   "
139002|NCT01747889|"~     This study is designed to compare the Thopaz chest tube drainage system to the traditional~     collection chamber system. The Thopaz system is already in clinical use in the United States~     and throughout the world. As such, this study is not evaluating safety or efficacy of this~     system both of which have already been demonstrated. This study's primary aim is to determine~     whether the use of a digital chest drainage system compared with a traditional system affects~     duration of chest drainage and length of hospital stay.~      Furthermore, we aim to determine whether the use of a digital chest drainage system compared~     with a traditional system increases the total distance of ambulation in the first 48 hours~     after thoracic surgery and affects overall patient satisfaction in the peri-operative period.~      Finally, we want to determine whether the aforementioned outcomes relative to the chest tube~     drainage systems differ in different parts of the world.~   "
139003|NCT01747876|"~     LEE011 is a small molecule inhibitor of CDK4/6. LEE011 has demonstrated in vitro and in vivo~     activity in both tumor models.~      The primary purpose of this study is to determine the maximum tolerated dose (MTD) and/or~     recommended dose for expansion (RDE) in pediatric patients and to delineate a clinical dose~     to be used in future studies. This study will also assess the safety, tolerability, PK and~     preliminary evidence of antitumor activity of LEE011 in patients with MRT or neuroblastoma.~   "
139004|NCT01747863|"~     A multicenter observational pilot study will be conducted to determine the natural history of~     infants with early diagnosis (≤ 6 hrs of age) of mild neonatal encephalopathy (NE) who are~     not qualified for therapeutic hypothermia. The intervention includes: neurologic examination~     by using modified Sarnat score at ≤ 6 hrs of age, 24 hrs and before discharge home,~     amplitude-integrated electroencephalography (aEEG) at 6 ± 3 hrs of age, brain MRI at before~     discharge home to 30 days of age and follow-up at 18-22 months of age. Primary outcome is the~     percentage of mild NE infants with evidence of brain injury defined by the presence of at~     least 1 abnormality of brain MRI, aEEG or neurologic examination in the neonatal period.~     Secondary outcome is the percentage of brain MRI, aEEG and neurological exam abnormalities,~     seizure, length of hospital stay, need of gavage feeds or gastrostomy at discharge home,~     death and long-term outcome.~   "
139005|NCT01747850|"~     The purpose of this study is assess Sativex as a treatment for Cannabis dependence. Initially~     a pilot study will be conducted in five subjects seeking treatment for cannabis dependence to~     ensure that our planned self-titration regimen is appropriate using Sativex. This phase will~     be open label, with no placebo control. Then, there will be a twelve-week, double-blind,~     placebo-controlled study in male and female subjects seeking treatment for cannabis~     dependence (n=40). All participants will receive a combination of pharmacotherapy (Sativex~     Spray or Placebo Spray) associated with a weekly intervention of combined Motivational~     Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT). The subjects will have to~     come daily to the centre to assess usage of medication. Following the medication phase,~     participants will have a follow-up weekly for another four weeks and then monthly until the 6~     month follow up visit after the target quit date. The investigators are planning to enroll 45~     subjects over the two-year period.~   "
139006|NCT01747837|"~     The objective of this trial is to determine the efficacy and safety of adjunctive~     catheter-based renal sympathetic denervation (RSDN) in the primary prevention of ICD therapy~     in patients with ischemic or non-ischemic ventricular dysfunction, who are to receive an ICD~     for either i) secondary prevention, or ii) primary prevention + inducible VT by programmed~     ventricular stimulation at the time of ICD implantation. These patients will be randomized to~     ICD alone or ICD + RSDN.~   "
139007|NCT01747824|"~     The purpose of this project is to determine the levels of stress biomarkers associated with~     severe pain, agitation from intoxication or psychosis, and excited delirium at various levels~     of the disease in order to compare them to pre-clinical models of law enforcement encounters.~     We hypothesize that the serum catecholamines and markers of metabolic acidosis will worsen~     with the duration and severity of agitation among agitated patients and will not worsen among~     patients with severe pain who are not agitated.~      Specific Aims~        -  To assess the prevalence of patients undergoing treatment for agitation from any cause~          requiring restraint or sedation.~        -  To assess the prevalence of excited delirium in the emergency department.~        -  To determine the difference in serum total catecholamines, serum dopamine, serum~          epinephrine, serum norepinephrine, heart rate, systolic blood pressure, mean arterial~          pressure, mortality, and disposition among patients with agitation requiring restraint,~          including excited delirium and patients with severe pain from extremity fractures.~        -  To describe changes in stress biomarkers among patients with changing levels of~          agitation as determined by the Altered Mental Status scale.~   "
139026|NCT01747577|"~     The purpose of this study is to demonstrate superiority of the solifenacin succinate~     (treatment) over the placebo (control) based on the change from the baseline in the mean~     number of urgency episodes per 24 hours after 2 weeks.~   "
139027|NCT01747564|"~     The purpose of this study is to evaluate safety and absorption, distribution and elimination~     of mirabegron after oral administration to Chinese subjects.~   "
139031|NCT01747512|"~     Doctors at the Cross Cancer Institute have developed a new method of producing 99mTc~     Pertechnetate in a cyclotron unit. A study done at the Cross Cancer Institute in 2011 with~     ten patients using this imaging agent showed that it was safe and produced images with the~     same pattern as generator produced Pertechnetate. This study is now being done in larger~     numbers of patients to again show that the imaging pattern of both agents is the same, and to~     again demonstrate its safety.~   "
139008|NCT01747811|"~     Mild traumatic brain injuries (mTBI) or concussions are an increasingly prevalent injury in~     our society. Patients with post-concussion syndrome have been shown to have deficits on tests~     of short term memory, divided attention, multi-tasking, information processing speed, and~     reaction time, as well as alteration in mood and emotional functioning. Many patients have~     other vague complaints including fatigue, dizziness, irritability, sleep disturbances, and~     chronic headaches. Furthermore, sleep disruption of one of the most common complaints in~     patients suffering from traumatic brain injuries, with as many as 40 to 65% of patients with~     mTBI complaining of insomnia. Sleep problems in these patients are associated with poorer~     outcome, while resolution of the sleep disturbance is associated with improvement in~     cognitive functioning.~      Despite recent evidence of the correlation between sleep quality and recovery from traumatic~     brain injury, and the well-established role of sleep in neural plasticity and neurogenesis,~     there have been virtually no direct studies of the causal effects of sleep on recovery~     following mTBI. However, it is quite likely that sleep plays a critical role in recovery~     following brain injury.~      A particularly promising non-pharmacologic approach that shows potential in~     improving/modifying abnormalities of the circadian rhythm and sleep-wake schedule is bright~     light therapy. For the proposed investigation, we hypothesize that bright light therapy may~     be helpful in improving the sleep of patients with a recent history of mTBI and may also have~     other mood elevating effects, both of which should promote positive treatment outcome in~     these individuals. Bright light therapy may increase the likelihood that they will recover~     more quickly, benefit more extensively from other forms of therapy, and build emotional and~     cognitive resilience.~   "
139009|NCT01747798|"~     This pilot clinical trial studies auranofin in treating patients with epithelial ovarian,~     primary peritoneal, or fallopian tube cancer. Immunosuppressive therapy, such as auranofin,~     may be an effective treatment for epithelial ovarian, primary peritoneal, or fallopian tube~     cancer.~   "
139010|NCT01747785|"~     This study is being done to study how well the heart contracts and relaxes during exercise.~     In addition to traditional measures of heart function, we will use a new computer program~     that may improve understanding of why people feel shortness of breath or fatigue.~   "
139011|NCT01747772|"~     HYPOTHESIS: The investigators hypothesize that sonoelastography (SE) will provide accurate~     quantitative measurements that can be used to stage liver fibrosis in patients with chronic~     liver disease.~        1. To measure liver stiffness with sonoelastography in adults with suspect diffuse liver~          disease who will undergo non-focal liver biopsy as part of their routine clinical care~        2. To assess the sensitivity and specificity of sonoelastography for the detection and~          staging of liver fibrosis~        3. To evaluate the effect of steatosis and inflammation on the estimation of liver fibrosis~          using sonoelastography~   "
139012|NCT01747759|"~     The benefit of preoperative rehabilitation treatment combining physiotherapy and targeted~     education for patient undergoing Total Knee replacement (TKR) is now well known. Thus, there~     is lack of validated booklet containing evidence based informations.~      Our aim is to assess the impact of an evidence based education pre-operative booklet on~     patient's knowledge and beliefs. The secondary objectives are to assess the impact of the~     booklet on patient's satisfaction on the information received, the length of stay in~     orthopedic surgery and the transfer rate to rehabilitation wards.~      To show a difference of 2 points on the knowledge score (range 0-10) between the two groups,~     with a = 0.05 and a power of 90%, we considered that 44 patients are needed. The evaluations~     will take place at baseline, the day before surgery and 6 weeks post-surgery on knowledge and~     beliefs scores at each visit and on a satisfaction score on the last one. Quantitative data~     will be compared between groups by the Kruskal-Wallis and qualitative parameters via Fisher~     exact test.~      The study protocol was approved by the local Ethic Committee.~   "
139013|NCT01747746|"~     The purpose of this study is to determine that a new drug called Rivaroxaban® is effective~     in preventing patients from forming clots after their heart rhythm has been reset by the~     cardiologist with an electrical device.~   "
139014|NCT01747733|"~     Use of sedation is often required in endoscopic procedures such as ERCP (endoscopic~     retrograde cholangiopancreatography). However, assessment of the level of sedation during~     these procedures is not investigated in detail.~      The purpose of this study is to compare different sedation scales and bispectral index during~     sedation in endoscopic procedures in order to find the best suited assessment method for~     sedation under these conditions.~   "
139015|NCT01747720|"~     There is some evidence that vitamin D could be used to reduce breast cancer risk. Randomized~     controlled trials would provide definitive evidence about this effect. However, trials with~     breast cancer as outcome are expensive and time-consuming. Use of surrogate outcomes has been~     advocated to accelerate progress in the identification of interventions that could prevent~     breast cancer. Mammographic breast density is one of the strongest breast cancer risk~     indicators and is already used as a surrogate outcome in several breast cancer prevention~     trials. The aim of this double-blind randomized controlled trial is to determine whether~     daily oral supplementation with vitamin D3 (1,000, 2,000 or 3,000 IU) over a period of 1 year~     reduces breast density in premenopausal women compared to placebo. A total of 376 women (94~     per arm) who live in Quebec City will be recruited. Showing that vitamin D reduces breast~     density would provide strong support for the idea that vitamin D can be a safe and~     inexpensive approach for the prevention of breast cancer.~   "
139016|NCT01747707|"~     The combination of Cisplatin and S-1 (CS) achieved a response rate of approximately 45% with~     the PFS being around 6 months and overall survival time being 13 months in Japanese and~     Chinese gastric patients. It remains unclear whether the addition of docetaxel to CS would~     further enhance the efficacy as it dose in DCF(docetaxel, cisplatin and 5-fluorouracil). This~     is a single center, phase II clinical trial to evaluate the efficacy of docetaxel, cisplatin~     and S-1 (DCS) as first line chemotherapy for patients with advanced gastric and~     gastroesophageal junction cancer.~   "
139017|NCT01747694|"~     COPD patients often suffer from dyspnea and exercise intolerance which lower their quality of~     life.The aim of this proposed study is to examine the effectiveness of multi-respiratory~     muscle training on respiratory function of COPD patients.~   "
139028|NCT01747551|"~     Anti-angiogenic therapy is a proven therapeutic target in refractory gastric and~     gastroesophageal junction adenocarcinoma. This trial assessed whether the addition of a high~     affinity angiogenesis inhibitor, ziv-aflibercept, could improve the efficacy of first-line~     mFOLFOX6 (oxaliplatin, leucovorin, and bolus plus infusional 5- fluorouracil) chemotherapy in~     metastatic esophagogastric adenocarcinoma.~      In this study (ZAMEGA), patients with treatment-naïve esophagogastric adenocarcinoma were~     randomly assigned 2:1 in a multicenter, placebo-controlled double-blind trial to receive~     first-line mFOLFOX6 with or without ziv-aflibercept 4mg/kg every 2 weeks. Randomization was~     stratified by ECOG performance status (0-1 vs. 2) and primary site of disease (esophagus or~     GE junction vs stomach).~   "
139018|NCT01747681|"~     Articular cartilage lesions are commonly occurring. In a prospective study of 1,000 knee~     arthroscopies focal chondral or osteochondral defects were found in 19% of the patients~     (Hjelle 2002). Chronic articular cartilage defects do not heal spontaneously. However, acute~     traumatic osteochondral lesions or surgically inflicted lesions extending into subchondral~     bone, e.g. by drilling (Pridie 1959), spongialization, abrasion or microfracture with an~     angled awl (Rodrigo 1994) causing the release of pluripotent mesenchymal stem cells from the~     bone marrow, may heal with repair tissue consisting of fibrous tissue, fibrocartilage or~     hyaline-like cartilage. The microfracture technique causes little damage to the subchondral~     bone plate and the risk of heat necroses caused by drilling or abrasion is eliminated. The~     quality of the repair tissue after these bone marrow stimulating techniques depends on~     various factors including the species and age of the individual, the size and localization of~     the defect, the surgical technique, e.g., how the subchondral bone plate is treated, and the~     postoperative rehabilitation protocol. Microfracture has been used in small traumatic defects~     in young sporting individuals (Steadman 2003) as well as in larger osteoarthritic lesions in~     older patients (Miller 2004, Steadman 2007). The purpose of the present study was to~     investigate the long-term clinical outcome 10 to 14 years after microfracture of articular~     cartilage defects in the knee and possible predictors of good and poor outcomes.~   "
139019|NCT01747668|"~     To investigate the impact of nutrient supplementation during lactation on levels in breast~     milk.~   "
139020|NCT01747655|"~     Patients with advanced Parkinson's Disease experience a range in the severity of their motor~     fluctuations. The rationale for this Post Marketing Observational Study is to demonstrate the~     benefits of Duodopa treatment on Parkinson's Disease patients entering the advanced stage of~     the disease whose motor fluctuations have become troublesome and complicate management with~     oral therapy. The aim of this post-marketing observational study is to assess the effect of~     Duodopa treatment on activities of daily living in advanced Parkinson's Disease participants~     characterised by either 2-4 hours of off time or 2 hours of non-troublesome or troublesome~     dyskinesia daily, supported by a Unified Parkinson's Disease Rating Scale Total Score in the~     best on state of at least 40 points at baseline.~   "
139021|NCT01747642|"~     Oncoxin in combination with Surafenib is safe and results in improved survival in patients~     with hepatocellular carcinoma (HCC)~   "
139022|NCT01747629|"~     The primary objective of this study is to evaluate the efficacy of Albuterol Spiromax® versus~     placebo in subjects with persistent asthma.~   "
139023|NCT01747616|"~     The dry eye syndrome DES is a highly prevalent ocular disease, in particular in the elderly~     population. One mainstay of therapy for patients suffering from DES is the use of topically~     administered lubricants. However, despite many efforts, no ideal formulation has yet been~     found.~      Recently, Croma Pharma has introduced chitosan-N-acetylcysteine eye drops, designed for~     treatment of symptoms related to DES. Chemically, chitosan is a polycationic biopolymer with~     favourable biological properties such as high biocompatibility and low toxicity.~     Additionally, the new formulation comprises N-acetylcysteine, which has been used in~     ophthalmology because of its mucolytic properties for several years. Based on theoretical~     considerations, one can hypothesize that the new chitosan derivative may show an increased~     adhesion to mucins of the ocular surface and may therefore be particularly beneficial in~     reducing the symptoms associated with DES. We have recently shown in a phase I trial that~     single instillation of chitosan-N-acetylcysteine eye drops is well tolerated in young healthy~     subjects.~      However, no data is yet available about safety and tolerability of chitosan-N-acetylcysteine~     in subjects wearing contact lenses. This is of special interest because the tear film is~     critical to successful contact lens wear. Disturbances of the quantity or quality of the tear~     film results in intolerance of contact lens wear and possible damage to the ocular surface.~     This trial seeks to investigate the local tolerability and possible ocular discomfort of~     chitosan-N-acetylcysteine eye drops after repeated instillation .~   "
139024|NCT01747603|"~     This pilot study will examine the feasibility of conducting a large randomized clinical trial~     (RCT) to examine the role of a novel, specialized follow-up clinic in preventing~     complications among late preterm infants (LPTB), born between 34 and 36 weeks gestational~     age. 1) Study Process: Success will be achieved if 80% of a target population of 100 subjects~     is met within the first 6 months of recruitment being initiated. 2) Study Resources: Success~     will be achieved if 80% of follow up appointments are scheduled in a timely manner and if~     specialized LPTB physicians in the intervention complete assessments 75% of the time in the~     allocated time frame and 3) Scientific: 95% data completeness on data collection forms will~     be identified as success~      A specialized LPTB follow-up clinic is innovative as no studies have evaluated such a~     programme and standardized follow-up and guidelines for the care of LPTB infants after~     discharge from hospital do not exist. Until recently, the incorrect assumption has been that~     these infants are healthy and have limited risks compared to term infants.~      The study's main question, in addition to assessing the feasibility of this pilot, is: Do~     differences exist in short-tem clinical and developmental outcomes among LPTB infants~     enrolled in an RCT who are randomized to a specialized LPTB follow-up programme when compared~     to infants randomized to current pragmatic management? A RCT will provide evidence for the~     development of guidelines for the follow-up of LPTB infants in the first 6 months of life to~     reduce complications, readmissions and developmental problems.~      The results of this study can be generalized to tertiary care and community hospitals and the~     general population.~   "
139025|NCT01747590|"~     The primary goal of this double-blind, placebo-controlled, within-subjects functional~     neuroimaging study is to examine the extent to which the hypnotic zolpidem decreases brain~     activity in regions of the brain known to process emotional information. Although zolpidem is~     an effective sleep-aid, its ability to engender anti-anxiety effects is equivocal, yet~     promising. Zolpidem's activity during tasks that engage anxiety-related processes in the~     brain will be compared to that of the known anxiolytic drug alprazolam, a positive comparator~     caffeine, and placebo. A secondary goal of this study is to compare the subjective drug~     effects, or how individuals feel, following the interventions. These measures will be used to~     determine the existence of brain-behavior relationships, thus demonstrating that imaging is~     an important tool for informing us about how drugs produce their effects in the brain.~   "
139032|NCT01747499|"~     The purpose of this phase I/II study is to define the maximum tolerated dose of 5-AzaC and~     the effect on grade II-IV GvHD when given after matched unrelated donor transplant (MUD).~   "
139033|NCT01747486|"~     This is a randomized, open-label, parallel group study to determine the optimal dose of~     CART-19 cells (autologous T cells expressing CD19 chimeric antigen receptors expressing~     tandem TCR Zeta and 4-1 BB co-stimulatory domains) of the two dose levels being assessed~     (1-5x10e8 vs. 1-5x10e7 CART-19 cells). This trial will be conducted in two stages.~   "
139034|NCT01747473|"~     Determine accuracy specifications and labeling claims of a pulse oximeter in a diverse~     subject population during severe signal interference over a specified saturation range.~   "
139035|NCT01747460|"~     To determine accuracy specifications of the Pulse oximeter.~   "
139036|NCT01747447|"~     The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a randomized clinical trial in~     25,874 U.S. men and women investigating whether taking daily dietary supplements of vitamin~     D3 (2000 IU) or fish oil (1 gram of omega-3 fatty acids) reduces the risk of developing~     cancer, heart disease, and stroke in people who do not have a prior history of these~     illnesses. This ancillary study is being conducted among a sub-cohort of 771 participants in~     VITAL and will test the efficacy and safety of high-dose vitamin D supplementation vs.~     placebo on skeletal health and body composition.~   "
139037|NCT01747434|"~     Acute patients in Denmark are often admitted to Emergency Departments by their General~     Practitioner with a presumptive diagnosis.~      The aim of this study is to evaluate the diagnostic value of the pre-admission presumptive~     diagnosis and to assess if the presumptive diagnosis could be replaced by a number of~     symptom-based groups.~   "
139038|NCT01747421|"~     In Emergency Departments patients admitted with chest pain may suffer from non-significant to~     lifethreatening conditions.~      The aim of the present study is to develop and validate a referral model in chest pain~     patients which divide the patients with non- significant ECG changes into high risk and low~     risk groups for acute coronary syndrome.~   "
139039|NCT01747408|"~     The proposed study was set up to evaluate the tolerability and safety of 25% human albumin~     (HA) therapy in patients with subarachnoid hemorrhage (SAH). It is estimated that 37,500~     people in the USA have SAH every year. SAH is associated with a 51% mortality rate and one~     third of survivors are left functionally dependent. Cerebral vasospasm (CV) has been~     identified as the most important reason for neurological deterioration. CV may be due to~     multiple molecular mechanisms. The use of a neuroprotective agent with various actions, likes~     HA, would be important for prevention of CV and improved clinical outcome in patients with~     SAH. The proposed open-label, dose-escalation study will have important public health~     implications by providing necessary information for a definitive phase III clinical trial~     regarding the efficacy of treatment with HA in patients with SAH. The study was to enroll a~     maximum of 80 patients with SAH who meet the eligibility criteria. Four dosages of HA (0.625,~     1.25, 1.875, and 2.5 g/kg) administered daily for seven days will be evaluated. The lowest~     dosage was to be evaluated in the first group of 20 subjects. A specific safety threshold was~     defined based on data from previous studies. The Data and Safety Monitoring Board approved or~     disapproved advancing to the next higher HA dosage based on the evaluation of the rate of~     congestive heart failure (CHF). The study assessed three outcomes: safety and tolerability of~     the HA dosages and the functional outcome. The primary tolerability outcome was defined as~     the subject's ability to receive the full allocated dose of HA without incurring frank CHF~     that requires termination of treatment. Secondary safety outcomes were serious adverse events~     (including neurological and medical complications, and anaphylactic reactions). Neurological~     complications comprise incidence of CV, rebleeding, hydrocephalus, and seizures after~     treatment. The three-month functional outcome determined, by Glasgow Outcome Scale, Barthel~     Index, modified Rankin Scale, NIH Stroke Scale and Stroke Impact Scale was measured to obtain~     a preliminary estimate of the treatment effect of HA. The timeline of the study is three~     years.~   "
139040|NCT01747395|"~     The investigators hypothesize that aerobic exercise training associated with respiratory~     muscle training will cause additional benefits compared to isolated exercise training or~     respiratory training in chronic heart failure patients.~   "
139041|NCT01747382|"~     Recent clinical studies have demonstrated that catheter-based renal sympathetic nerve~     ablation is safe and effective in treating patients with resistant hypertension. However,~     there is limited data on its safety and efficacy in patients with Chronic Kidney Disease.~      The investigators hypothesize that catheter-based renal sympathetic nerve ablation is safe~     and effective in the treatment of resistant hypertension in patients with Chronic Kidney~     Disease.~   "
139042|NCT01747369|"~     The aim of this study is to estimate the burden of disease due to pneumococci, other bacteria~     and viruses in the African meningitis belt prior to pneumococcal conjugate vaccine~     introduction and to estimate the population impact of the vaccine after its implementation in~     2014. In a defined population of a sanitary district in northern Togo, during the period 2010~     to 2017, investigators enroll patients of all ages with suspected pneumonia requiring~     hospitalization or suspected bacterial meningitis. Patients are evaluated by bacteriology and~     molecular biology techniques on blood, cerebro-spinal fluid, nasal aspirates and by chest~     X-ray.~   "
139043|NCT01747356|"~     Resolute zotarolimus-eluting stent (ZES) system (Medtronic, USA) has been world-wildly used~     in treating patients with coronary artery disease (CAD). The State Food and Drug~     Administration of China has approved qualification of RESOLUTE zotarolimus-eluting stent~     system in 2010. It has been reported that RESOLUTE stent may be more suitable for DM patients~     and FDA has approved diabetic coronary lesion as a indication for using Resolute stent. Here~     the investigators set out a multicenter, non-inferiority study: the efficacy and safety of~     RESOLUTE zotarolimus-eluting stents in treatment of Chinese diabetes (RESOLUTE-DIABETES~     CHINA) in purpose of identifying the efficacy and safety in Asia CAD correlated with diabetic~     population.~   "
139044|NCT01747343|"~     The investigators are interested in determining those procedures that prove to be most~     efficient and effective in facilitating continence (i.e., dry pants or the absence of~     soiled undergarments), appropriate eliminations (i.e., voids/stools in toilet), and~     independent requests/initiations to use the toilet. To assess the effectiveness of toilet~     training methods (procedures), data on toileting skills (in addition to each skill in a given~     child's curriculum) are collected across the school day (7:30 am-5:45 pm) by the classroom~     teachers. The primary dependent variables (toileting skills) are continence (i.e., absence of~     soiled undergarments), appropriate eliminations (i.e., the number of voids/stools made in the~     toilet), and independent/self requests (i.e., communication by the child with an adult to use~     the toilet). The toileting procedures are implemented by classroom teachers (undergraduate~     practicum students) and implementation is monitored by classroom supervisors (graduate~     teaching assistants). Procedural effectiveness is evaluated on a daily basis by the graduate~     teaching assistants and on an at-least-weekly basis by faculty supervisors.~   "
139045|NCT01747330|"~     The purpose of this study is to evaluate the safety and tolerability of Creon micro in~     children younger than four years with pancreatic exocrine insufficiency.~   "
139046|NCT01747317|"~     Fractional Flow Reserve derived from computed tomography(FFRCT) is a novel method for~     determining the physiologic significance of coronary artery disease (CAD), which will help~     physicians in clinical decision-making and decrease the medical cost, but its ability to~     identify patients with ischemia has not been adequately examined to date.~   "
139047|NCT01747304|"~     DXA scanners are routinely used to assess bone mineral density (BMD) and fracture risk in~     osteoporosis patients. They provide detailed bone imaging in a low radiation setting. Hologic~     manufactures scanners that are able to perform high definition instant vertebral fracture~     assessment (HD-IVA) used to screen at-risk patients for asymptomatic spine fractures~     instantly and reliably at the same time they are having their yearly BMD. We wish to~     investigate whether this same proven technology (HD-IVA scan mode) used on femurs (the scan~     mode is now called SE Femur scans) can be used to screen for atypical fractures of the femur~     in patients at risk for these debilitating fractures. In this proof of concept study, we~     propose to examine whether DXA scanners can provide a sensitive low radiation screening~     method to identify incomplete AFFs in patients with known incomplete AFFs and in patients at~     risk.~   "
139048|NCT01747291|"~     Osteoporosis is a disease characterized by increased bone fragility and deteriorating bone~     micro-architecture. The main consequence of osteoporosis is low-trauma fractures, most often~     of the hip, spine and wrist. Recently, another type of low-trauma fracture, atypical femur~     fractures (AFFs), have received much attention. Little is known of the cause of these~     debilitating fractures; however, they have been associated with long term bisphosphonate use.~     What we currently know about AFFs is based on case reports or small case series, or studies~     using administrative databases or secondary analyses of bisphosphonate trials. While these~     reports provide some preliminary information on the relationship between long term~     bisphosphonate exposure and AFFs, detailed clinical data are absent. As we have established a~     network of specialists across southern Ontario our group is in a position to collect~     meaningful information on a larger group of patients who have experienced these debilitating~     fractures into a centralized AFF registry.~   "
139049|NCT01747278|"~     Evaluation the efficacy and safety profile of trimethoprim/sulfamethoxazole as Pneumocystis~     carinii pneumonia (PCP) prophylaxis in Patients With Connective Tissue Diseases (CTD) treated~     with high-dose glucocorticoids and immunosuppressive agents.~      Open-labeled, randomized, prospective single-center clinical trial. Observation period of 12~     weeks.~   "
139050|NCT01747252|"~     This study was designed to assess the pharmacokinetics of 2 doses of Red Grape Cells (RGC)~     containing resveratrol compared with a reference. RGC will be administered as single oral~     dose to fasting healthy volunteers. Plasma concentration of free resveratrol and total~     conjugates will be analyzed.~   "
139051|NCT01747239|"~     Ovarian cancer patients are considered platinum refractory if their disease worsens during~     primary platinum treatment or if they have no effect of the treatment. This constitutes a~     major therapeutic problem and new treatment approaches are highly needed.~      Cabazitaxel (Jevtana®) is a new taxane with effect in breast and prostatic cancer. In both~     tumors it has effect in patients refractory to taxotere. Consequently, it could be~     anticipated that cabazitaxel may have an effect in platinum refractory ovarian cancer.~   "
139052|NCT01747226|"~     Bad breath or halitosis is caused by specific gases originating from the mouth or the expired~     air. In most cases the pathology lies within the mouth and in this case receives the name~     pathologic halitosis of oral cause or oral malodor. The aim of this study is to evaluate the~     immediate (masking) and long term (therapeutic) effect of commercially available mouth rinses~     in the treatment of oral malodor. For this volunteers with oral malodor detected by~     organoleptic evaluation and confirmed by the increase level of sulphur compounds in their~     breath (VSC) will be asked to use a designated mouthwash. The breath parameters will be~     assessed at baseline and 15' after the first rinse (15 ml, during 1 minute) and over night at~     the end of a period of 3 weeks during which the volunteers rinsed twice a day (15 ml, 1~     minute) with the assigned mouthwash. The short and long term effect of a stannous~     fluoride/amine fluoride/zinc rinse; a chlorhexidine/cetylpyridinium chloride/zinc product and~     a negative control(fluoride rinse and/or water) will be compared.~   "
139053|NCT01747213|"~     Background:~      - Alzheimer s disease (AD) is a brain disease that impairs memory, cognitive abilities and~     the ability to function independently. It is the most common cause of dementia in older~     people. It is caused by abnormal proteins in the brain that affect how neurons communicate~     with each other. Researchers are looking for drugs that can slow down the disease or treat~     its symptoms. One drug, called bisnorcymserine (BNC), may help improve brain function and~     symptoms in people with AD. BNC is designed to block a chemical that affects how neurons~     communicate with each other. Researchers want to see how BNC works in healthy older~     volunteers.~      Objectives:~      - To look at how the body processes bisnorcymserine taken by mouth and how safe it is for~     healthy older volunteers.~      Eligibility:~      - Healthy volunteers at least 55 years of age.~      Design:~        -  Participants will be screened with a physical exam, medical history, and blood and urine~          tests.~        -  Within 3 weeks from the screening visit, participants will come to the National~          Institute on Aging clinical unit for a 2-night stay. On the morning of the second day,~          they will take either a BNC capsule or a placebo. They will not know which tablet they~          are taking.~        -  Blood samples will be collected frequently throughout the second and third days of the~          study visit. The last blood sample will be collected about 32 hours after taking the~          study capsule. Participants will have heart function tests and other exams during the~          visit. Once the tests are done, they will leave the clinical center.~        -  Participants will have a final follow-up visit about 1 week after leaving the clinical~          center.~   "
139062|NCT01747096|"~     Evaluation of the diagnostic performance of PET / CT with 68Ga-DOTANOC in~     Gastroenteropancreatic Neuroendocrine Tumors with comparison with other techniques used in~     routine clinical practice (octreoscan ® ; multiphase SPECT / CT, MRI or endoscopy).~      Therapeutic impact and safety of PET / CT with 68Ga-DOTANOC will also be assessed. Expected~     results are a confirmation of the superiority of 68Ga-PET DOTANOC versus scintigraphy~     octreoscan ®, with a potential impact on the therapeutic management of patients.~   "
139063|NCT01747083|"~     This study is designed to investigate the food-effects on FDC(gemigliptin/metformin HCl~     sustained release) 50/1000mg(25/500mg x 2tablets)~   "
139054|NCT01747200|"~     Background:~      - The brain has natural rhythms called brain waves. An electroencephalogram (EEG) can record~     these rhythms. When people identify the picture of a familiar object shown on a computer~     screen, the communication between certain regions of the brain increases. An EEG can detect~     these communication brain waves. Transcranial magnetic stimulation (TMS) can affect these~     brain waves by slightly changing the brain s rhythms. Researchers want to see if changing~     brain rhythms with TMS interferes with the ability to identify pictures of familiar objects.~     This study will provide more information about how TMS can affect brain waves and behavior.~      Objectives:~      - To see if TMS can interfere with the brain s ability to identify pictures of familiar~     objects.~      Eligibility:~      - Healthy volunteers between 18 and 70 years of age.~      Design:~        -  This study requires two visits to the clinical center. The first visit will last about 2~          hours. The second visit will last about 4 hours.~        -  Participants will be screened with a physical exam and medical history.~        -  At the first visit, participants will have an object recognition test. Participants will~          look at pictures of several objects on a computer screen. They will then have to state~          whether the objects they see on the screen are familiar. The object recognition test~          will be done along with TMS.~        -  At the second visit, participants will have an EEG while taking the object recognition~          test. Brain waves will be monitored during the test. They will then repeat the test~          while having repetitive TMS to study its effect on object recognition. The participants~          will then take the object recognition test alone for a final time. This will make sure~          that TMS effects (if any) on the ability to identify familiar object images are no~          longer present.~   "
139055|NCT01747187|"~     Septic shock is a major cause of death in intensive care. Septic shock is often dominated by~     profound changes in organ functions, of which cardiac failure is one of the most severe. In~     septic shock, biological markers of cardiac stress are often elevated. It is not known to~     what extent this indicates structural damage to the heart, or in what way they correlate to~     echocardiographic signs of heart failure.~      Here, cardiac failure in ICU patients with septic shock is studied, using biological markers~     of cardiac stress, inflammatory parameters and echocardiography.~      Investigators hypothesize that biomarkers of cardiac stress correlate with echocardiographic~     signs of heart failure, and that they can predict an increased risk of death.~   "
139056|NCT01747174|"~     The purpose of this study is to determine whether intra-coronary adenosine or sodium~     nitroprusside (SNP) delivered selectively via a thrombus aspiration catheter (or if~     unsuccessful via a coronary microcatheter) following thrombus aspiration in Primary~     Percutaneous Coronary Intervention (P-PCI) reduces microvascular obstruction (MVO) parameters~     and infarct size as measured with cardiac MRI, compared with standard treatment following~     thrombus aspiration in patients presenting with ST-elevation myocardial infarction (STEMI).~   "
139057|NCT01747161|"~     In this study we will investigate the efficacy and safety of infiltration of the vestibulum~     vaginae with botulin toxin in women who were diagnosed with localized provoked vulvodynia. In~     literature covering this subject we find that the prevalence of this condition is between 10~     and 15%. Especially young, sexually active women suffer from this problem and some of them~     are not capable of having sexual relations with their partner because of this burning pain.~      The most probable explanation for the physiopathological mechanism is an increase of nerve~     endings in the epithelium of the vestibulum, with an increase and activation of pain~     receptors in the vestibular mucosa. It also seems that patients with vestibulodynia have a~     higher tonus of the pelvic floor muscles, a greater muscle contraction in response to pain~     and a lower capacity of relaxation.~      Botulin toxin (Botox) is a neurotoxin that causes a temporary paralysis of the muscle cells.~     That way it can decrease the increased tension of the pelvic floor muscles Botox also~     inhibits the pain receptors in the vestibulum.~      Patients will be recruited through the gynecology consultations. Every patient with localized~     provoked vulvodynia that has tried previous treatments (pelvic floor muscle therapy,~     antidepressants, anti-epileptics, local anesthetics) will undergo Q-tip testing. If positive~     and there are no underlying diseases, the patient will be invited to participate in the study~     and after oral and written informed consent, will be included in the study population. Every~     6 weeks there will be given injections with 50 units of botulin toxin, on 6 different spots~     in the vestibulum. 50 % of the subjects will receive physiological water instead of Botox~     (control population). After 3 sessions, we will assess if there is any difference in provoked~     pain in treated patients vs. placebos through Q-tip testing.~   "
139058|NCT01747148|"~     Background:~      - Influenza (flu) is a virus that causes people to get sick. Most of the time, the flu causes~     only a mild illness, but some people can become seriously ill or even die from it. Currently,~     some pills and inhaled powders can be used to treat the flu, but they only make flu symptoms~     end about a day sooner. More treatment choices for the flu are needed, especially for those~     who become seriously ill. Researchers want to test a new drug, AVI-7100, that might keep a~     person who takes it from having a more serious case of the flu.~      Objectives:~      - To see how healthy adult volunteers tolerate the AVI-7100 anti-influenza drug.~      Eligibility:~      - Healthy volunteers of normal weight between 18 and 60 years of age.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. A heart function test will also be performed.~        -  Participants will have either AVI-7100 or a placebo infusion. They will not know which~          infusion they have. . Participants will stay at the clinical center for a total of 8~          hours after the infusion. Blood samples will be collected 1, 2, 4, and 8 hours after the~          end of the infusion~        -  Participants will return on Days 1, 2, 4, 10, and 28 after receiving the drug. Blood and~          urine samples will be collected. A heart function test will also be performed.~        -  There will be a second part of the study that is separate from the first one. Additional~          people will receive either AVI-7100 or placebo to test their reactions to a specific~          dose.~   "
139059|NCT01747135|"~     Background:~      - Hydroxypropyl beta cyclodextrin (HPBCD) is being tested for a disease called Niemann-Pick~     disease type C1 (NPC1). NPC1 is a genetic disorder that results in gradual loss of nervous~     system function. Cholesterol and other fats have trouble moving out of the brain cells, which~     makes the cells work poorly and leads to symptoms. There is no treatment currently approved~     in the US for NPC1. Researchers want to test if it is safe to use HPBCD for NPC1. They want~     to see if it can help brain cells process cholesterol better.~      Objectives:~      - To test the safety and effectiveness of HPBCD for NPC1.~      Eligibility:~      - Individuals between 2 and 25 years of age who have been diagnosed with NPC1 and who have~     not already received HPBCD in an attempt to treat NPC1.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will~          provide blood and urine samples for screening. They will also have neurological tests,~          including tests of hearing, speech and movement.~        -  Participants will have a lumbar puncture (also called a spinal tap) every month to~          deliver the drug to the spinal fluid that surrounds the brain. The length of the trial~          will be determined by the safety and efficacy information that is obtained.~        -  Treatment will be monitored with frequent blood and urine tests, cerebral spinal fluid~          tests, hearing and neurological exams.~   "
139060|NCT01747122|"~     The investigators plan to compare epidurals versus wound catheters for effects on pain relief~     and recovery following open liver surgery.~   "
139061|NCT01747109|"~     Oro-tracheal intubation in intensive unit care(ICU) in acute hypoxemic respiratory failure~     after crash induction remains a critical event.~      The aim of this study is to determine whether Nasal High Flow Therapy (HFT) Optiflow ® is~     more efficient than the face mask for preoxygenation before orotracheal intubation after~     crash induction in acute hypoxemic respiratory failure~   "
139064|NCT01747070|"~     The objective of this study is to evaluate the efficacy of transcranial direct current~     stimulation (tDCS) and electro acupuncture (EAC) compared to sham treatment in reducing pain,~     improving functional capacity and functioning of the neuro-immune-endocrine system in~     patients with chronic pain due to knee osteoarthritis.~   "
139065|NCT01747057|"~     Our hypothesis is that hemodynamic fluid resuscitation guided by dynamic parameters will~     improve outcome in patients with severe sepsis and septic shock, by limiting the deleterious~     effects of fluid overload.~   "
139066|NCT01747044|"~     Fibromyalgia affects 0.7 to 3.3% of the adult population and 7-10 times more women than men.~     In France, the prevalence is 1.6% according to a French study conducted in 2009 and published~     in 2011 by Serge Perrot et al.~      The definition of fibromyalgia was recently amended with particular consideration of~     cognitive and somatic symptoms, factors not involved in the initial criteria of the ACR~     classification. Several factors are in favor of a malfunction of the central modulation of~     pain and poorer performance noxious inhibitory controls descendants (DNIC: diffuse noxious~     inhibitory controls) have been demonstrated. In fibromyalgia patients, the DNIC (diffuse~     noxious inhibitory controls) are altered with less pain inhibition than controls. Dysfunction~     of the central pain modulation is widely described in the literature and contributes to pain~     complained of fibromyalgia.~      According to the Recommendations of the European League Against Rheumatism (EULAR) 2006,~     antidepressants have a genuine analgesic efficacy in controlled studies. Milnacipran is an~     antidepressant known and used in major depressive disorder according to its marketing~     authorization but is also part of the molecules used in the treatment of chronic neuropathic~     pain and fibromyalgia according to the recommendations of the EULAR. A review included five~     double-blind studies on 4,000 participants who took 100 mg or 200 mg milnacipran or placebo~     over a period of 8 weeks to 24 weeks. A moderate response was obtained for 40% of~     participants treated for each dose of milnacipran on the criteria of at least 30% pain~     relief Impression and global change. Substantial improvement with milnacipran compared to~     placebo has been shown.~      To date, the link between the weakening of DNIC in fibromyalgia and effectiveness of drug~     treatment has not been shown.~      This study aims to assess the degree of impairment of DNIC in fibromyalgia patients may be~     predictive of the efficacy of milnacipran.~   "
139067|NCT01747031|"~     The iFRCT study is a prospective, multicenter study to evaluate the diagnostic performance of~     iFRCT with the use of ≥64-detector row CT scanners for the detection and exclusion of~     significant obstructive coronary artery disease, defined by invasive fractiona flow reserve~     (FFR) as the reference standard.~   "
139068|NCT01747018|"~     Platelet-rich plasma (PRP) has been used as an alternative to non-operative treatments for~     increasing the rate of cure in bone and soft-tissue regeneration, although there are very few~     clinical studies regarding the treatment of articular cartilage damage. Therefore, our study~     proposes non-surgical intervention for patients with articular cartilage damage and who are~     experiencing knee pain caused by this damage.~      This study was conducted as a single medical center. It was an uncontrolled, prospective~     clinical trial, and the study subjects included 44 patients who were suffering from early~     osteoarthritis and degenerative chondropathy; they were between 18 and 65 years of age and~     were included in the study irregardless their sex. PRP was injected twice intraarticulary~     within an interval of four weeks. The pain scores and functional scores were compared two~     months, four months, and six months following the second injection was completed, using the~     VAS, the Lysholm knee scale, and the Cincinnati knee rating system.~   "
139069|NCT01747005|"~     The aim of study is to determine effect of enhanced recovery after surgery (ERAS) on~     inflammatory response after abdominal hysterectomy.~   "
139070|NCT01746992|"~     T cell lymphoma is a heterogenic malignancy with poor outcome. Five-year PFS and OS of the~     patients recieved classic CHOP regimen(cyclophosphamide,vincristin,doxorubicin and~     predisone)is less than 30%.High dose intensive chemotherapy doesn`t demonstrate better~     response. At present, there is no standardized treatment protocol for this kind of lymphoma.~      Between 1994 and 1998,the Scotland and Newcastle Lymphoma Group prospectively collected data~     on newly diagnosed patients with enteropathy associated T-cell lymphoma (EATL)in the Northern~     Region of England and Scotland,which is a rare and aggressive type of peripheral T-cell~     lymphoma.The novel regimen IVE/MTX (ifosfamide, vincristine, etoposide/methotrexate)-ASCT was~     piloted for patients eligible for intensive treatment,followed by auto-stem cell~     transplantation.Five-years PFS and OS were 52% and 60% respectively, significantly improved~     compared with the historical group treated with anthracycline-based chemotherapy. The~     encouraged results were extended to the peripherial T cell lymphoma-non specified(PTCL-nos).~      Past studies suggested pirarubicin was more active to the T cell lymphoma than doxorubicin in~     vitro based on its high concentration in tumor cells. Clinical data also presented equivalent~     even superior efficacy of pirarubicin with lower toxicity than doxorubicin. The aim of our~     study is to compare the response and survival rate of CTOP/ITE/MTX (cyclophosphamide,~     vincristin,pirarubicin and predisone/ ifosfamide, pirarubicin, etoposide/methotrexate) with~     those of CHOP regimen,looking forward to its superiority in efficacy and safety for the de~     novo young patients with T cell lymphoma.~   "
139071|NCT01746979|"~     This Phase 3 trial is a randomized, double-blind, placebo-controlled trial of gemcitabine in~     combination with TH-302 compared to gemcitabine in combination with placebo in subjects with~     locally advanced unresectable or metastatic pancreatic adenocarcinoma. Randomized subjects~     will receive TH-302 plus gemcitabine or gemcitabine plus placebo in 4-week cycles until there~     is evidence of progressive disease, intolerable toxicity, or the subject discontinues from~     the trial for other reasons (for example, withdrawal of consent). The primary efficacy~     endpoint is overall survival (OS) time. The data cut-off for statistical analyses of the~     primary and secondary endpoints will be reached when 508 events (deaths) will be reported. No~     planned interim analyses will be conducted. An Independent Safety Monitoring Board (ISMB)~     will provide periodic evaluations of the unblinded safety data to ensure subject safety and~     the validity and scientific merit of the study. A total of 660 subjects will be enrolled.~   "
139072|NCT01746966|"~     1. Investigate Gleno-Humeral Joint (GHJ) by anterior approach:~           A - Measurement of GHJ thickness at 3 points and average value calculation on body~          supine position and with arm supinated, maximal externally rotated with elbow angle 90~          degrees~             -  By longitudinal access with transducer position laterally to coracoids along to the~               GHJ line, located as diagonal form lower to forward and lateral direction with~               demonstration the joint cartilage posteriorly and subscapular tendon anteriorly~               (Fig.4)~             -  By transversal access with 90 degrees to longitudinal and at 3 points: upper with~               coracoids visualization, middle and lower (Fig.5-7).~           B - Measurement of rotator interval with assessment of width and higher.~        2. Comparison of the data with results of classic values have been received by posterior~          and inferior (axillar) approach.~        3. Comparison of the results between patients with Rheumatoid Arthritis (RA) and healthy~          controls~   "
139073|NCT01746953|"~     We will evaluate the effect of red blood cell (RBC) transfusion on fatal and non fatal events~     according to baseline risk of death in an international cohort of trauma patients (CRASH-2~     trial). The following outcomes will be considered: death from all causes, death due to~     bleeding, death due to multiorgan failure, death due to vascular occlusive events and non~     vascular occlusive events. Non fatal outcomes include: myocardial infarction, stroke, deep~     vein thrombosis and pulmonary embolism.~   "
139074|NCT01746940|"~     This study aims to evaluate topical application of Cocaine HCl 4% and 10% on safety and~     efficacy in local (topical) anesthesia for diagnostic procedures and surgeries on or through~     accessible mucous membranes of the nasal cavities.~   "
139075|NCT01746927|"~     This investigation was designed to assess if the the position of esophageal entrance would~     detrmine the cricoid force necessary to occlude the esophageal lumen? in anesthetized,~     paralyzed non obese patients using the Glidescope ® video laryngoscope (GVL).~   "
139076|NCT01746914|"~     72 hours after lung transplantation, patients undergo a positron emission tomography (PET)~     scan and a computed tomography (CT) scan in order to analyse lung function and morphology.~      Aim of the study is to analyse complications onset (in particular primary graft dysfunction),~     and evaluate 90 days mortality after lung transplantation.~   "
139077|NCT01746901|"~     The main purpose of this study is to determine if oxycodone and naltrexone combination~     capsules (ALO-02) have the potential to be abused.~   "
139078|NCT01746888|"~     Gold standard diagnostic criteria for diagnosing acute infection in older adult patients in~     the Emergency Department do not currently exist. These patients often have atypical~     presentations which can complicate diagnosis and treatment. The development of an~     antimicrobial stewardship program for Emergency Department older adult patients can~     ultimately improve the accuracy of diagnosis and correct antimicrobial prescribing. This~     research study involves data collection from enrolled subjects and treating physicians. The~     data will be collected using a patient interview which will be answered directly by the~     patient or caregiver. Additional surveys will be administered to the Emergency Department~     treating physician and subsequent physician. Additional data will be abstracted from the~     Emergency Department chart and from additional charts that often accompanies the patient to~     the Emergency Department. A physician adjudication process will occur if there is~     disagreement in diagnosis between the treating Emergency Department physician and succeeding~     physician.~   "
139079|NCT01746875|"~     The purpose of this study is to determine treatment effects in patients with retinal pigment~     epithelium detachment (PED) in relation to Age Related Maculopathy (AMD). Patients with newly~     diagnosed PED without choroidal neovascularisations (CNV), will be randomized to either~     treatment or observation. The treatment group will first be given injections with anti~     Vascular Endothelium Growth Factor (anti-VEGF). If the injections do not have any effect,~     Verteporfin Photodynamic Therapy (PDT) will be given. All patients will be followed for a~     period of 2 years. It is hypothesized that treatment stops the progression of the disease and~     stabilizes the vision in this subgroup of patients with AMD.~   "
139080|NCT01746862|"~     This is an open-label, multi-center, randomized, two-arm parallel, no-treatment group~     controlled (only for the first 6 months), Phase 3 study in children with ISS. The subjects~     will be treated with 0.067 milligram/kilogram/day (mg/kg/day) of Saizen®, weight base dose,~     for 12 months (12 months of treatment in the test group, and 6 months of no treatment and~     then 6 months of treatment in the control group).~   "
139081|NCT01746849|"~     The purpose of this study is to help determine if palifermin and leuprolide acetate can help~     the immune system recover faster following a stem cell transplant. Blood stem cells are very~     young blood cells that grow in the body to become red or white blood cells or platelets. The~     transplant uses stem cells in the blood from another person. The donor can be a family member~     or a volunteer donor. This is called an allogeneic stem cell transplant.~      The investigators want to see if palifermin and leuprolide acetate can help the immune system~     recover faster after an allogenic transplant because experiments have shown they may be able~     to do this.~   "
139082|NCT01746836|"~     The goal of this clinical research study is to learn if ponatinib can help to control CML in~     chronic phase. The safety of this drug will also be studied.~      Ponatinib is designed to block the function of BCR-ABL, which is the abnormal protein~     responsible for causing CML. This may cause the cancer cells to die.~      Ponatinib may cause a blood clot to form in an artery or in a vein. Depending on the location~     of the clot, this could cause a heart attack, a stroke, severe damage to other tissue, or~     death. A blood clot may occur within 2 weeks after you start taking the drug. About 25% (1 in~     4) of patients taking the drug form an abnormal clot. Blood clots can occur in patients that~     do not have other known risk factors for forming clots. If you develop a blood clot, you will~     need to stop taking ponatinib. In some cases, emergency surgery could be needed to remove the~     clot and restore blood flow.~   "
139083|NCT01746823|"~     There is currently no medication for containing KC, nor any adequate biomarkers to predict~     the disease. Furthermore, there is considerable confusion in the field regarding the~     pathophysiology of the disease and involvement of inflammation. To that end, this study is~     designed to address some of these questions by determining the proteomic profiles of KC~     patients with different clinical grades. This relatively large cohort study is expected to~     yield significant information regarding the molecules that are deregulated during progression~     of KC and may provide a framework to assign diagnostic biomarkers and therapeutic~     intervention points.~   "
139084|NCT01746810|"~     This phase I trial studies the side effects and best dose of stereotactic body radiation~     therapy when given together with ablation therapy in treating patients with non-small cell~     lung cancer or lung metastases. Ablation therapy, such as radiofrequency ablation uses a~     high-frequency, electric current to kill tumor cells. Ablation therapy, such as microwave~     ablation kills tumor cells by heating them to several degrees above normal body temperature.~     Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and~     cause less damage to normal tissue. Giving ablation therapy together with stereotactic body~     radiation therapy may kill more tumor cells.~   "
139085|NCT01746797|"~     This study assesses risk factors for depressive relapse in women undergoing fertility~     treatment with histories of major depressive disorder (MDD) or bipolar disorder. The study is~     focused on the acute risk factors of depressive relapse.~      The investigators hypothesize that risk for depressive relapse will be greater among women~     who stop antidepressants compared to those who continue treatment with these agents.~   "
139086|NCT01746784|"~     The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of~     N6022, and to obtain descriptive information on the effect of N6022 on biomarkers of CFTR~     function and inflammation in adult cystic fibrosis subjects who are homozygous for the~     F508del-CFTR mutation.~   "
139087|NCT01746771|"~     [Phase I] The main objective of this study is to evaluate the safety, tolerability and~     determine the Recommended Dose (RD) of HM781-36B(Poziotinib)combined with Paclitaxel and~     Trastuzumab~      [Phase II] The main objective of this study is to evaluate anticancer activity through~     determination of response rate of HM781-36B(Poziotinib)combined with Paclitaxel and~     Trastuzumab in patients with HER-2 positive advanced gastric cancer~   "
139088|NCT01746758|"~     The study hypothesis is that managed referral of patients at community level (from drug~     stores) increases uptake of reproductive health (RH) services at dispensary and health centre~     levels.~      The intervention is currently being implemented in 2 districts (Magu and Sengerema) in Mwanza~     Region on the northwest shore of Lake Victoria. It is nested within the IntHEC Community~     Randomised Trial which aims to evaluate the impact of a complex RH intervention on the uptake~     and integration of reproductive health services in 2 Regions in Tanzania (Mwanza and Iringa)~     and Niger (Say and Aguie) respectively. 18 wards per region were stratified according to~     geographical and economic criteria and randomly assigned to intervention or comparison wards.~     The SMS intervention is being implemented in 9 intervention wards in Mwanza Region only. 9~     wards are followed for comparison.~   "
139089|NCT01746745|"~     This is a single dose study of radiolabelled LY2940680 taken by mouth in healthy participants~     to study how the body absorbs and removes LY2940680 from the blood. This study is for~     research purposes only and is not intended to treat any medical condition.~   "
139090|NCT01746732|"~     The purpose of this study is to evaluate the effects of evacetrapib on oral contraceptives~     (Ortho-Cyclen®) when given to healthy female participants. The amount of female hormones~     found in the blood will be measured and compared when taken alone and when taken with~     evaceptrapib. Each woman will participate in two study periods. Information about any side~     effects that may occur will also be collected.~   "
139091|NCT01746719|"~     This is a open Label, balanced, randomized, single dose, two-treatment, two-sequence,~     two-period, crossover pivotal study. The purpose of this study is to assess the~     bioequivalence between Test Product and the corresponding Reference Product under fasting~     condition in healthy, adult human subjects.~   "
139092|NCT01746706|"~     Reliable diagnosis of Alzheimer's Disease (AD) at the predementia stage is currently~     considered to be a priority for research, as disease modifying therapies are being evaluated.~     Many studies focus on the functional and morphological assessment of the hippocampal~     formation. However, neurofibrillary tangles, associated with cognitive deficits, initially~     affect the anterior subhippocampal cortex (transentorhinal, entorhinal and perirhinal cortex)~     before reaching the hippocampus. Studies from our group have tried to investigate if the~     assessment of subhippocampal regions using cognitive tools and neuroimaging techniques could~     contribute to the diagnosis of AD at a very early stage.~      In a previous project, the investigators included 40 patients with single domain amnestic MCI~     (Mild Cognitive Impairment), known to be at high risk for AD and demonstrated that aMCI~     patients with a profile of subhippocampal dysfunction (impaired performance on a visual~     recognition memory task) display other clinical as well as imaging profiles of patients with~     early AD using MRI and SPECT. Longitudinal follow-up data in these patients is currently~     under way. Preliminary data indicates that evaluating the subhippocampal region using visual~     recognition tasks is highly predictive of AD over 6 years.~      The aim of this project is to obtain additional diagnostic data using a PET amyloid tracer~     (Florbetapir F18 AV45 F18), an in-vivo marker of one of the neuropathological lesions that~     define AD, of in order to enhance diagnostic accuracy AD in these patients. This approach~     will validate the hypothesis as to whether the assessment of subhippocampal dysfunction can~     contribute to the early diagnosis of AD.~   "
139093|NCT01746693|"~     Amblyopia is a developmental condition that is characterized by reduced vision of the eye due~     to the presence of a sensory impediment during visual development, such as strabismus (ocular~     misalignment) or anisometropia (unequal refractive error), occurring early in life. Recent~     studies in humans and animals point towards a cortical locus for the processing deficit in~     amblyopia, revealing sensory deficits at the signal cell level. If changes in retinal~     neuronal function are also present, is unknown.~      Like in the brain, blood flow in the retina is coupled to neuronal activity. This phenomenon~     has been measured by different study groups with non invasive techniques in the brain and~     retina. It has been shown in previous studies that stimulating the retina with diffuse~     luminant flickering light increases retinal vessel diameter and blood flow. However, it is~     unknown whether this is also the case in the retina of amblyopic eyes. Additionally, the~     introduction of blood oxygen level dependent (BOLD) fMRI also makes it possible to directly~     access the vascular response in the brain to visual stimuli.~      Therefore, the aim of the present study is to investigate the effect of luminant flickering~     light on retinal vessel diameter and retinal blood flow in subjects with amblyopia. Also,~     oxygen saturation in retinal vessels will be assessed as well as pattern ERG for assessment~     of retinal function. Additionally, a high resolution image of the visual pathway will be~     taken with 7 Tesla MRI to investigate whether anatomical or functional alterations are~     present.~   "
139094|NCT01746680|"~     The aims of this study are to assess the efficacy and safety of tacrolimus in patients with~     active rheumatoid arthritis(RA). EULAR(European League Against Rheumatism) response at week~     24 compared to baseline will be evaluated to assess the efficacy of Tacrolimus.~   "
139095|NCT01746667|"~     The current study aims at comparing the efficacy of exposure in vivo and exposure via virtual~     reality for social anxiety disorder. 70 patients with social anxiety disorder will be~     randomized to either one of the active conditions or to a waiting-list condition.~     Participants on the waiting-list will be offered either exposure in vivo of in virtual~     reality after a waiting period of five weeks. Levels of psychopathology will be assessed at~     pre- and post-treatment as well as three and 12 months after treatment.~   "
139096|NCT01746654|"~     The purpose of this study is to determine whether the antibacterial protein P128 is (i) safe~     and well tolerated in healthy volunteers and in chronic kidney diseases patients on dialysis,~     (ii) is it effective in reducing the nasal carriage of pathogen (Staphylococcus aureus) in~     humans.~   "
139098|NCT01746628|"~     When having certain types of outpatient surgery inside the uterine cavity some women~     experience heavy bleeding. The only method presently available for controlling such bleeding,~     short of removing the uterus, involves the placement of a balloon pressure device inside the~     uterine cavity. The pressure along with the patient's own natural clotting ability will~     generally stop the bleeding. However, this treatment usually requires at least a 24 hour stay~     in the hospital. The investigators are researching the use of a compound (FloSeal) already~     approved for use in other areas of the human body, as a method of controlling bleeding. The~     use of FloSeal in the uterine cavity has not yet been tested and therefore is not yet an FDA~     approved indication for its safe use to control bleeding from the uterine cavity. In this~     study, The investigators want to find out what effect(s) FloSeal has on the uterine cavity.~      Twenty individuals will be included in this study at Northwest Hospital Center. All twenty~     individuals will be treated in the same fashion except ten of the participants will randomly~     be assigned to receive FloSeal and ten will not.~      Study participants are individuals currently scheduled to have a hysterectomy procedure,~     which involves surgically removing the uterus from the body for a previously determined~     standard of care treatment for a non- cancerous medical problem. Before performing the~     hysterectomy and evaluating the effects of FloSeal upon the tissues within the uterine cavity~     the following will be done. Once under anesthesia the uterine cavity will be subjected to a~     curettage (sharp scrapping) to produce a minor amount of bleeding from the lining of the~     uterus. Ten of the 20 study participants, randomly chosen, will then have FloSeal placed into~     their uterine cavity. The study participants will not know whether they received FloSeal or~     not. A balloon pressure device will then be placed into the uterine cavity of all 20~     individuals and left in place for 5 minutes. After the allotted time, the balloon device will~     be removed. The hysterectomy will then be completed appropriately using standard methods and~     techniques. The uterus, once removed will be evaluated pathologically to determine the~     effects of the FloSeal upon the tissues of the cavity in those so treated and compared to the~     same analysis in those individuals who did not receive FloSeal. The pathologist will not know~     which patients received or did not receive FloSeal.~      This use of FloSeal is not currently an FDA approved use of the compound. The goal of this~     study is to obtain FDA approval for use in this situation.~   "
139099|NCT01746615|"~     Assessment of retinal vessel calibers combined with bidirectional Fourier domain optical~     coherence tomography (FDOCT) for measurement of retinal blood velocities is a new and~     sophisticated method for assessing retinal blood flow in humans. The valid measurement of~     retinal blood flow is of significant importance, because it is known that major ophthalmic~     diseases are associated with alterations in blood flow.~      As such, retinal vascular occlusive diseases represent a major cause of visual impairment and~     blindness. The prevalence of the disease is between 0.7 and 1.6%. Compression of the retinal~     veins at arterio-venous (AV) crossings plays an important role in the development of branch~     retinal vein occlusion (BRVO). The mechanical narrowing of the vessel lumen is supposed to be~     the mechanism behind this fact. The present study should elucidate how BRVO influences~     retinal blood flow at retinal vessel crossings in comparison to healthy control subjects.~     Retinal blood flow at retinal bifurcations will also be assessed. In addition, a fundus image~     will be taken to assess retinal oxygen saturation.~      For the first time we use a combination of a dynamic vessel analyzer (DVA) with bidirectional~     Fourier domain optical coherence tomography (FDOCT) to assess retinal blood flow. Whereas the~     DVA provides information concerning retinal vessel caliber, FDOCT provides laser Doppler~     information in addition to conventional optical coherence tomography, allowing the~     observation of blood flow dynamics simultaneously.~      In the present study we hypothesize that the DVA in combination with FDOCT is a suitable new~     tool for the assessment of blood flow in healthy subjects and in patients with BRVO.~   "
139100|NCT01746602|"~     Long term treatment with anti-glaucomatous drugs has been shown to increase the incidence of~     dry eye syndrome with all known consequences such as ocular discomfort and epithelial~     keratitis. Given that thinning of the tear film appears to be a risk factor for the~     development or the aggravation of dry eye syndrome, the current study seeks to investigate~     whether tear film thickness is changed after topical treatment with anti-glaucomatous drugs~     in healthy subjects.~      For this purpose, tear film thickness will be measured at baseline and after single~     instillation of one of 5 study drugs in one randomly chosen eye. In addition, one group of 20~     subjects will receive no drug and will serve as a second control. Drug effects on tear film~     thickness will be compared to the fellow, non-treated eye. In addition, effects on tear film~     thickness of timolol with preservatives (Timoptic 0.5%) will be compared to timolol without~     preservatives (Timophtal sine 0.5%) and three lubricants with different viscosity (Genteal~     HA, Hylo-Comod, Thealoz).~   "
139101|NCT01746589|"~     Evaluate visual outcomes and contrast sensitivity for subjects undergoing bilateral myopic~     LASIK procedure using the 200 kHz WaveLight® FS200 Femtosecond Laser and the WaveLight®~     Allegretto Wave® Eye-Q Laser. The use of advanced technology may decrease the loss of~     contrast sensitivity and improvement of postoperative visual acuity results.~   "
139102|NCT01746576|"~     The purpose of this study is to determine whether analysis of near infrared absorbance~     signals that occur at different frequencies might provide information about the difference in~     oxygen saturation between arterial and venous blood.~   "
139103|NCT01746563|"~     To evaluate the efficacy of combination therapy with ranibizumab (RBZ) and panretinal~     photocoagulation (PRP) versus PRP alone in patients with treatment-naive bilateral~     proliferative diabetic retinopathy (PDR) as measured by mean change in visual acuity (VA),~     mean change in central retinal thickness (CRT) as measured by time-domain optic coherence~     tomography (TD-OCT) and incidence of vitreous hemorrhage (VH).~   "
139104|NCT01746550|"~     The purpose of this study is to assess the safety and effectiveness of the MD-12-001 stent in~     the treatment of superficial femoral artery and proximal popliteal artery blockages in~     Japanese patients.~   "
139105|NCT01746537|"~     A prospective, observational, case series investigating the feasibility of utilizing OCT~     scans of the anterior chamber of eyes with uveitis.~   "
139106|NCT01746524|"~     This post-marketing investigation will evaluate the functional knee performance of Subjects~     who have undergone primary total knee arthroplasty (TKA). Data from Subjects who receive one~     of four contemporary knee configurations will be pooled to establish a contemporary dataset.~      The primary objective of this study is to evaluate the pre-operative (approximately -90 to -1~     day before surgery) to minimum one year (approximately 304 to 668 days) postoperative~     functional performance improvement for the Attune™ primary, cemented TKA system as measured~     by the activities of daily living (ADL)subscore of the Knee Osteoarthritis Outcomes Score~     (KOOS)questionnaire (KOOS-ADL sub-score). This will be carried out for all four implant~     configurations: cruciate retaining fixed bearing (Attune™ CR FB), cruciate retaining rotating~     platform (Attune™ CR RP), posterior stabilized fixed bearing (Attune™ PS FB), and posterior~     stabilized rotating platform (Attune™ PS RP).~   "
139107|NCT01746511|"~     The purpose of this study is to find out if giving glycerin suppositories will help decrease~     the length of time premature infants need phototherapy.~      The investigators hypothesize that glycerin suppositories (initiated along with phototherapy)~     will have no effect on reducing duration of phototherapy in premature infants with jaundice.~   "
139108|NCT01746498|"~     The current study is planed to compare the efficacy of real (anodal and cathodal) vs sham~     transcranial direct current stimulation (tDCS) applied over the left dorsolateral prefrontal~     cortex (DLPFC) on cognitive functions and cortical excitability of patients with Alzheimer~     disease (AD).~      Thirty three with mild to moderate Alzheimer's disease (AD) patients (diagnosis of probable~     AD according to the criteria of the National Institute of Neurological and Communicative~     Disorders and Stroke Alzheimer Disease and Related Disorders Association [NINCDS-ADRDA] were~     included in this study) were randomly classified into one of three groups (eleven for each~     group). The first group received anodal tDCS over left DLPFC and 2rd group received cathodal~     tDCS on the left DLPFC and the 3rd group received sham tDCS stimulation, daily for 10~     consecutive days (5 days/week for 2 weeks). Minimental State Examination (MMSE), psychometric~     assessment for cognitive functions (MMSE, Wechsler memory scale, Wechsler adult Intelligent~     scale) were assessed before, after 10th sessions, and then after 1 and 2 month. Cortical~     excitability was assessed in both hemispheres before and after the end of sessions.~     Neurophysiological evaluations included resting and active motor threshold (rMT and aMT), and~     cortical silent period (CSP).~      At the time of recruitment, none of the patients taking antidepressants, or neuroleptic,~     sedative-hypnotic drugs for at least two weeks before the assessment. All participants or~     their caregivers will give informed consent before participation in the test and after full~     explanation of the study protocol.~      Outcome: The real group received (anodal and cathodal) tDCS are expected to have more~     improvement on cognitive functions compared to sham tDCS group. tDCS is considered new~     adjuvant non pharmacological therapeutic tool for management of AD patients with mild to~     moderate degree dementia.~   "
139109|NCT01746485|"~     To evaluate the pharmacokinetics of three-times daily dosing of UT-15C in healthy volunteers~   "
139110|NCT01746472|"~     Effective evidence-based interventions exist for smoking cessation delivered over the~     Internet, but consumer acceptance and adherence remains low. Scalable and efficient~     mechanisms to disseminate these interventions online are needed, and existing online social~     networks provide a potential mechanism. This is a proposal for a randomized, factorial trial~     of the dissemination of an evidence-based intervention through the massive Facebook social~     network, with the goal of determining intervention characteristics that drive viral spread.~   "
139111|NCT01746459|"~     Currently, the health care that people receive is approximately 20 years behind up-to-date~     research findings. Developing ways to narrow the gap between evidence and practice is an~     important research focus in continuing care facilities, especially when one considers that~     the demand for these facilities is estimated to increase ten-fold in the next 25 years. In~     Alberta, there are an estimated 27,400 healthcare aides working in the continuing care~     sector. Developing reminders targeting these care providers will increase the likelihood that~     the significant resources invested to promote the uptake of research findings will lead to~     sustained practice change and, ultimately, improved client outcomes. The purpose of the START~     project (Sustaining Transfers through Affordable Research Translation) is to help bridge this~     gap between research and practice in supportive living and long-term care facilities by~     studying the effectiveness of reminder interventions to support the sustainability of a~     research-based mobility innovation. In particular, the project will evaluate the frequency~     and intensity of reminders that maintain the daily practice of healthcare aides to carry out~     a mobility innovation with clients in 24 supportive living and long-term care facilities. We~     will compare monthly versus every three month reminders, and we will compare paper-based~     reminders (like a sticker on a chart) and reminders provided by a healthcare aide peer. Using~     interviews, questionnaires and observations, the START project will also evaluate the~     processes that inhibit or promote the uptake of the mobility innovation by healthcare aides~     in their daily practice. In building this bridge between research evidence and practice, we~     will work closely with stakeholders at all levels of healthcare delivery (e.g. healthcare~     aides, facility leaders, policy makers and researchers) throughout the study. We expect our~     collaboration to contribute to sustainable innovations in the continuing care sector and, in~     particular, to the sustained use of an affordable mobility innovation in supportive living~     and long-term care settings.~   "
139112|NCT01746446|"~     The purpose of the study is to test a new model of care for patients with an ongoing or~     significant medical condition.~   "
139113|NCT01746433|"~     The main objective of this study is to compare the percentage of patients that successfully~     pass from a laying position to a sitting position in less than 10 seconds between study arms:~        -  experimental arm: these patients will use the ERGONOME device to help them sit up~        -  standard arm: these patients will use traditional hanging triangle bar to help them sit~          up~   "
139114|NCT01746420|"~     The purpose of this study is to determine whether recombinant human platelet-derived growth~     factor (rhPDGF-BB) Injection is effective in the treatment of lateral epicondylitis (tennis~     elbow).~   "
139115|NCT01746407|"~     Procure blood specimens from individuals presenting to the emergency department (ED) with~     signs and /or symptoms of systemic infection or sepsis. The samples will be used for research~     and development activities related to sepsis, infections, etc.~   "
139116|NCT01746394|"~     The Delta Healthy Sprouts Project is a randomized, controlled trial evaluating the~     enhancement of an existing Mother, Infant, and Early Childhood Home Visiting Program in 150~     African American women in their early second trimester of pregnancy. The control arm, Parents~     as Teachers, is an evidence-based approach to increase parental knowledge of child~     development and improve parenting practices. The experimental arm, Parents as Teachers~     Enhanced, builds on the Parents as Teachers curriculum by including nutrition and physical~     activity components specifically designed for the gestational and postnatal periods. Both~     arms of the intervention will be implemented by community-based, trained Parent Educators.~     The comparative effectiveness of the two intervention arms on weight status, dietary intake,~     and health behaviors of mothers and their infants will be assessed. The Delta Healthy Sprouts~     Project will determine if a novel, scalable, lifestyle intervention can improve the health of~     African American women and their children at high-risk for obesity and chronic disease.~   "
139117|NCT01746381|"~     Home non-invasive ventilation (NIV) is the standard-of-care as initial therapy for patients~     with ALS with worsening symptoms or deteriorating respiratory function, and has been~     recommended by the American Academy of Neurology (AAN) practice parameter for ALS.~      This study will compare the current standard BiST mode of ventilation with the new iVAPS~     mode. The main study hypothesis is that the iVAPS mode, initiated in a single daytime trial,~     will result in a reduction of the number of respiratory therapist interventions and changes~     in ventilator settings as compared with the standard BiST mode. This will be assessed over a~     period of one year. In addition this study will test whether the iVAPS mode is superior to~     BiST mode with respect to: comfort and ease of use; improvement in nighttime and daytime~     symptoms of hypoventilation; compliance (hours used per day); physiologic parameters (daytime~     and overnight oxygen saturation and transcutaneous CO2 level).~   "
139126|NCT01746251|"~     This research study is a Phase II clinical trial, which tests the safety and effectiveness of~     an investigational drug to learn whether the drug works in treating a specific cancer.~     Investigational means that the drug is still being studied. It also means that the FDA has~     not yet approved afatinib for use in patients.~      In this research study the investigators are looking to see if taking afatinib after surgery~     works better when taken over a short period of time, compared to a long period of time.~   "
139218|NCT01745055|"~     This study was designed to estimate the effects of methotrexate (MTX) on the pharmacokinetics~     (PK) of CP-690,550 when administered to subjects with rheumatoid arthritis (RA), to estimate~     the effects of CP-690,550 on the PK of MTX and to evaluate the short-term safety and~     tolerability of co-administration of CP-690,550 and MTX.~   "
139118|NCT01746368|"~     Objectives: The objectives of the pilot study were to (1) test the feasibility of~     recruitment, randomization, and retention; (2) test the feasibility of a standardized~     Nurse-Supported Advance Care Planning Intervention; (3) evaluate the feasibility of the~     assessment process and data collection procedures; (4) evaluate the Veterans' satisfaction~     with the intervention and their Advance Directive decisions; and (5) evaluate preliminary~     effects of the Nurse-Supported Advance Care Planning Intervention.~      Research Design: This was a prospective, randomized, controlled, unblinded pilot study.~     Alabama Veterans who received care through the Tuscaloosa VA Medical Center were randomized~     to either the Nurse-Supported Advance Care Planning Intervention or Care-as-Usual in a 2:1~     ratio respectively. Data related to recruitment, randomization, and retention; study~     completion by subjects; completeness of data collection; Veterans' satisfaction; and~     preliminary effects of the intervention were collected, analyzed, and evaluated. The length~     of the study was one year.~      Methods: The setting for the study was Tuscaloosa VA Medical Center care sites. A convenience~     sample of fifty subjects was recruited from Tuscaloosa VA outpatient clinics including Selma,~     residential settings, Home Based Primary Care, and the Mobile Health Unit. The level of care~     of subjects was all-inclusive, excepting current Hospice or Palliative Care. Selection~     procedures included self-referral and referral by Tuscaloosa VA Medical Center staff. Entry~     requirements were the meeting of all inclusion criteria and verification of no exclusion~     criteria. The Nurse-Supported Advance Care Planning Intervention was a manualized education,~     support, and guidance session provided by a Registered Nurse that included information about~     risks, benefits, and alternatives of specific choices. The Care-as-Usual was a session with~     the social worker who explained what the Advance Directive is, and guided the Veteran~     regarding the process of completing the Advance Directive document, without providing~     information about risks, benefits, and alternatives of specific choices. Study enrollment~     period was six months. The primary study outcome measure was Advance Directive completion~     rate. This pilot was not a hypothesis testing study. The underlying hypothesis of the~     eventual full study is that the Nurse-Supported Advance Care Planning Intervention is~     associated with Advance Directive completion rates at least comparable to that of the~     As-Usual care.~      Significance: This study supports the Veterans Health Administration (VHA) mission to provide~     Veteran-centered care. It provides important information needed to plan a full study of the~     effectiveness of a specific Nurse-Supported Advance Care Planning Intervention to facilitate~     Advance Directive completion by rural Alabama Veterans.~   "
139119|NCT01746355|"~     Atypical Facial Pain is a chronic condition and presents controversies during diagnostic and~     treatment, between specialist not have consensus about the pathophysiology. It is possible~     consider this entitie a potential neuropathic cause without pathological signs. It knows the~     repetitive transcranial magnetic presents good results in the treatment of chronic pain~     coditions. The aim this study is evaluated the thresholds and excitability cortical in~     patients with AFP and verify the patterns of improvement in pain for patients undergoing rTMS~     compared to controls, as well as the therapeutic response to neuromodulation procedures. This~     enroll 20 patients with DAF and 20 controls treated with rTMS (5 sessions) and evaluated~     through questionnaires (EDOF clinical record, McGill Pain Questionnaire, Visual Analogue~     Scale, Inventory of symptoms of neuropathic pain, neuropathic pain DN4 questionnaire, SF -36,~     brief pain inventory). At the end of the data will be statistically analyzed and expressed as~     mean and standard deviation, and analyzed by Student's t test, analysis of variance (ANOVA),~     Tukey-Kramer and Pearson correlation. The level of significance is 5%. The results will be~     published in journals indexed in the area both nationally and internationally and presented~     at conferences and scientific meetings.~   "
139120|NCT01746342|"~     Fatigue is highly prevalent among multiple sclerosis (MS) patients and has pervasive adverse~     effects on daily functioning and quality of life. The investigators found in a recent study~     that obstructive sleep apnea-hypopnea (OSAH) is the most common sleep abnormality in multiple~     sclerosis (MS) patients. There was also a significant relationship between OSAH and higher~     fatigue scores in MS patients. Preliminary work from the investigators in this group of~     subjects shows that treatment of sleep disorders (mostly OSAH) can improve fatigue and other~     symptoms in some MS patients. However, it is now necessary to systemically test the effect of~     OSAH treatment in a randomized, controlled study, to be sure that it really does improve~     fatigue and other symptoms. The best treatment for OSAH in the general population is~     continuous positive airway pressure (CPAP). This treatment has been well tolerated by most MS~     patients who have used the device at the investigators' center. This project will therefore~     be a randomized, controlled, clinical trial of CPAP in MS patients with OSAH. The effects of~     six months of CPAP treatment on fatigue as well as sleep quality, somnolence, pain,~     disability, and quality of life will be studied.~   "
139121|NCT01746329|"~     In the present study, muscle perfusion will be studied before and after an oral glucose~     challenge following a fasting period.~   "
139122|NCT01746303|"~     The aim of this study is to determine the efficacy of 6 months' dietary supplementation with~     omega-3 fatty acids and whole freeze dried blueberry powder in improving cognition in older~     adults. The effects of each of these interventions alone will also be assessed in order to~     determine whether the combined treatment confers synergistic or additive benefit relative to~     the effect of each therapy.~   "
139123|NCT01746290|"~     Sudden cardiac arrest occurs when someone's heart stops beating unexpectedly. Each year,~     more than 45,000 Canadians have a cardiac arrest. A bystander can do three things to improve~     survival: Call 911,start chest compressions and apply a defibrillator. Together, these~     actions can increase survival by up to 800%. The problem is that bystanders to cardiac arrest~     only provide CPR in about 3 of every 10 cardiac arrest cases and AED use in about 3 of every~     100 cardiac arrest cases. There are many people in the community who are trained and willing~     to provide help for cardiac arrest victims such as off-duty paramedics, fire fighters,~     nurses, etc. When a cardiac arrest occurs in the city, it is likely that one of these people~     is nearby, but unaware of the emergency. The PulsePoint smartphone application enables these~     people to be notified by the local emergency 911 service when there is a cardiac arrest near~     to them. It can be freely downloaded to several common types of smartphones. When there is a~     cardiac arrest emergency, all nearby PulsePoint users are sent an alert from the 911 service.~     When the phones receive the alert, they ring, vibrate and display a text message saying CPR~     NEEDED. The user's current location and the exact location of the cardiac arrest are then~     displayed on a map. Nearby public access AEDs are also indicated on the map. The smartphone~     users can then go to provide chest compressions and use an AED while paramedics are on their~     way. A video at www.pulsepoint.org shows how this works. The objective of the investigators~     is to measure whether the PulsePoint smartphone application increases bystander CPR or AED~     use for victims of cardiac arrest outside the hospital. This project will happen in the City~     of Toronto. The investigators have a plan to get as many people as possible to download the~     application, focusing on health care professionals who know CPR. The investigators will set~     up a webpage that helps people download the software to their phone. The investigators will~     randomize 911 calls to have a PulsePoint alert sent or not. The investigators will use~     statistical analysis to measure whether sending an alert to a smartphone increases the~     chances of bystander resuscitation.~   "
139124|NCT01746277|"~     There are two different treatment modes for NSCLC patients who failed to epidermal growth~     factor receptor-tyrosine kinase inhibitor (EGFR-TKI) after initially responding to EGFR-TKI.~     One is EGFR-TKI combined with chemotherapy and the other is chemotherapy followed by~     EGFR-TKI. It is unclear which one is more suitable to this group of lung cancer patients. So~     this phase Ⅱclinical trial is designed to compare the efficiency and safety of these two~     different treatment modes.~   "
139125|NCT01746264|"~     Vitamin D deficiency has been linked to endothelial dysfunction in adults. Obese adolescents~     have a high prevalence of Vitamin D deficiency as well as evidence of endothelial~     dysfunction. Our hypothesis is that supplementation of Vitamin D deficient adolescents with~     Vitamin D would lead to improvement in endothelial dysfunction.~   "
139219|NCT01745042|"~     The purpose of this study is to investigate anthropometric, metabolic, cardiovascular and~     symptomatic profiles in postmenopausal women.~   "
139127|NCT01746238|"~     The main purpose of this study is to test the safety, tolerability, maximum tolerated dose,~     and effectiveness of bevacizumab in combination with chemotherapy and radiation therapy.~      Because bevacizumab is not considered standard therapy for sarcomas, it can only be given to~     subjects with sarcoma who are enrolled in this research study and may only be administered~     under the direction of doctors who are investigators in this research study.~      This study is being done because sarcomas can recur after surgical resection (surgery for~     removal of the tumor), radiation therapy and chemotherapy. This recurrence can occur in the~     same location as the original tumor or in distant sites such as the lung. Thus better~     treatments are needed.~      This research study is a Phase I clinical trial. Phase I clinical trials test the safety of~     an investigational drug, combination of drugs, or combination of drugs with radiation. Phase~     I studies also try to define the appropriate dose of the investigational drug to use for~     further studies. Investigational means that the combination of drugs and radiation is still~     being studied and that research doctors are trying to find out more about it. It also means~     that the FDA has not approved bevacizumab with doxorubicin and radiation for your type of~     cancer.~   "
139128|NCT01746225|"~     Longer first line chemotherapy duration has recently been associated with a modest, but~     significant improvement in overall survival and a clinically meaningful and statistically~     significant improvement in progression-free survival, in metastatic breast cancer patients.~     Prolonging chemotherapy until disease progression, however, must be weighed against the~     detrimental effects of continuous chemotherapy delivery. The SNAP trial seeks to improve the~     tolerability of prolonged chemotherapy administration strategy by studying alternative~     treatment schedules, while preserving and possibly improving treatment efficacy in this~     disease setting.~      The availability of a new nanoparticle albumin-bound taxane, nab-Paclitaxel (Abraxane®),~     represents an opportunity to test this hypothesis. Nab-Paclitaxel has been developed in an~     attempt to reduce the toxicity associated with standard taxane administration (caused by the~     use of chemical solvents) while increasing antitumor efficacy.~      The SNAP randomized phase II trial evaluates three schedules of nab-Paclitaxel as prolonged~     chemotherapy administration strategy. Each of three arms will be compared to a historical~     reference of seven-month median progression-free survival (PFS) based on the most recent~     trial with docetaxel as control arm to determine whether any of the three arms are worthy of~     further investigation.~   "
139129|NCT01746212|"~     The purpose of this study is to report the radiographic, clinical, and functional outcomes of~     a consecutive series of patients diagnosed with single or bilateral degenerative disc disease~     between L4 and S1, that have been treated with an anterior lumbar interbody fusion (ALIF),~     anterior only surgical approach, and InQu Bone Graft Extender and Substitute for bony fusion~     and instrumentation.~      Patients that decide to undergo an Anterior Lumbar Interbody Fusion (ALIF) surgery [a~     surgical procedure that joins two or more lumbar vertebrae (small bones of the spine)~     together into one solid bony structure by approaching the spine through the abdomen (front of~     the body) and placing a bone graft in between the vertebral bodies where the disc usually~     lies], are invited to participate in an orthopaedic research study.~      This study will compare patients that have been treated with an anterior lumbar interbody~     fusion using InQu Bone Graft Extender & Substitute to published data for a stand alone spinal~     fusion surgery, where InFuse bone graft is placed between the transverse processes [small~     bony projections off the right and left side of each bone in your spine] of the affected~     vertebrae.~      X-rays, daily activities, and how patients are doing will be evaluated at specific time~     points during this study.~      The hypothesis of this study is that patients diagnosed with degenerative disc disease~     treated with an anterior lumbar interbody fusion, anterior only surgical approach (incision~     through the abdomen), using InQu Bone Graft Extender and Substitute and instrumented fixation~     have comparable radiographic (x-rays), functional (daily activities), and clinical (how the~     patient is doing) outcomes when compared to published data for use of InFuse in stand-alone~     fusion.~   "
139130|NCT01746199|"~     Given the resistance emergence of malaria in pregnant women receiving intermittent preventive~     treatment with sulfadoxine-pyrimethamine (IPT-SP) and the burden of this infection among~     pregnant women infected by HIV it is urgent to seek a more effective alternative treatment to~     optimize the prevention of malaria. Cotrimoxazole (CTM), actually administered daily as a~     prophylactic mean to opportunistic infections for HIV infected patients, showed encouraging~     results in preventing malaria in pregnant women. However, these results must be confirmed by~     randomized trials, particularly in pregnant women.~      The main objective of this clinical trial is to compare the efficacy of cotrimoxazole (CTM),~     administered once daily with IPT-SP (3 curative doses spaced one month) on placental~     parasitaemia in pregnant women infected with HIV and cluster of differentiation 4 (CD4) > 350~     cells/mm3.~      The main hypothesis is based on the premise that cotrimoxazole is more effective than IPT-SP~     for placental parasitaemia. This might be due to the higher plasma concentration of~     cotrimoxazole attained with daily doses. If this hypothesis is proven, cotrimoxazole could be~     recommended as prophylaxis for HIV-positive pregnant women, whatever their CD4+ cell count.~     In this study, the investigators will also test the hypothesis that the strains of Plasmodium~     falciparum isolated from HIV-positive pregnant women express more dhfr and dhps resistance~     markers.~   "
139131|NCT01746186|"~     The purpose of this study if to determine the specific contributions of energy intake and~     energy expenditure to changes in body weight and fat.~   "
139132|NCT01746173|"~     The current standard of care for the frontline treatment of peripheral T-cell lymphomas~     (PTCL) is induction chemotherapy followed by autologous stem cell transplantation (ASCT).~     However, many patients are unable to get to ASCT or relapse after ASCT, with a poor~     prognosis. Recently, a novel ASCT conditioning regimen of gemcitabine, busulfan and melphalan~     (Gem/Bu/Mel) has been reported to lead to favorable outcomes in this disease. We therefore~     designed a frontline regimen of CHOEP induction followed by Gem/Bu/Mel ASCT, and report the~     results of a phase 2 study of this regimen in patients with PTCL.~   "
139213|NCT01745120|"~     This is a non-randomized, open label, multi-site, single-dose, Phase 1/2 study in up to 18~     subjects (including at least 3 adolescents between 12 and 17 years of age, inclusive) with~     beta-thalassemia major. The study will evaluate the safety and efficacy of autologous~     hematopoietic stem cell transplantation (HSCT) using LentiGlobin® BB305 Drug Product~     [autologous CD34+ hematopoietic stem cells transduced with LentiGlobin® BB305 Lentiviral~     Vector encoding the human βA-T87Q-globin gene].~   "
139133|NCT01746160|"~     The aim of the study is to describe the changes found in C1 dental implants through their~     early healing period.~      Patients requiring a standard installation of one or two implants in the maxilla, without any~     need for bone augmentation, will be frequently followed for 90 days. In every meeting the~     implants' ISQ values (values denoting the implant stability as being measured by a dedicated,~     commercially available, appliance called 'Osstell').~      The implants' measured ISQ values will be used to describe the changes that may be found in~     the implants' stability through their healing period.~      At the end of the study the patients will be referred to their treating doctor for the~     completion of implants' restoration (i.e. crown).~   "
139134|NCT01746147|"~     The ALLIVE (ALLogeneic Iron inVEstigators) trial aims at quantifying the extent and dynamic~     change of LPI occurrence during conditioning and at identifying LPI-predictive~     peri-transplant parameters. Further points of interest are the improvement of systemic iron~     overload (SIO) diagnostics and the correlation of different SIO parameters with outcome after~     transplantation. The results of this trial will help to design prospective interventional~     studies addressing therapeutic options in patients at risk for SIO-associated toxicity during~     allogeneic stem-cell transplantation (allo-SCT).~   "
139135|NCT01746134|"~     This study is a disease-based registry designed to follow patients with a DSM-IV-TR~     (Diagnostic and Statistic Manual of Mental Disorders, Text Revision) diagnosis of~     schizophrenia, schizoaffective disorder, or schizophreniform disorder treated in usual care~     settings for up to 5 years. The registry seeks to describe the course of disease in~     schizophrenia, including cognitive function and negative symptoms, its treatment, and its~     burden of disease for participants, caregivers, clinicians, and society as a whole.~   "
139136|NCT01746121|"~     Amelogenesis Imperfecta (AI) are a heterogeneous group of rare genetic diseases transmitted~     according to various mode of inheritance (X-linked, autosomal dominant, autosomal recessive)~     affecting the formation/mineralization of tooth enamel. These diseases exist in isolation~     with clinical manifestations limited to the oral cavity or may be associated to other~     symptoms in syndromes. Many different genes (AMELX, ENAM, ENAMELYSIN or MMP20, KLK4, DLX3,~     FAM83H, FAM20A WDR72…) coding for enamel matrix proteins, enamel matrix degrading proteins,~     proteins involved in hydroxyapatite formation and growth and mineralization processes have~     been discovered responsible for the clinical phenotypes (hypoplastic, hypomineralized,~     hypomature) encountered in AI.~      Genes involved in enamel formation but not yet identified in association with any form of AI~     include: AMELY, AMELOBLASTIN, TUFTELIN, AMELOTIN, A Pin protein, ODAM (Odontogenic ameloblast~     associated).~      In this research protocol the investigators explore the phenotype including the enamel~     ultrastructure and the genotype of a cohort of patients presenting AI.~   "
139137|NCT01746108|"~     The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of GSK~     Biologicals' 10Pn-PD-DiT vaccine in children aged between 2 and 17 years of age having~     asplenia, splenic dysfunction or complement deficiencies.~      In addition, this study will include an age-matched control group of healthy children aged~     24-59 months in order to descriptively compare the immunogenicity of 10Pn-PD-DiT vaccine in~     the at-risk population to that of the general, healthy population one month after each~     pneumococcal vaccination.~   "
139138|NCT01746095|"~     The purpose of this study is to determine whether AeroVanc treatment is safe and effective in~     reducing the number of MRSA colony forming units in the lungs of cystic fibrosis patients.~   "
139139|NCT01746082|"~     This is a Phase II open-label study in approximately 200, and up to 240, healthy males and~     non-pregnant females, aged 18 years and older. This study is designed to assess the safety,~     reactogenicity, and immunogenicity of an unadjuvanted subvirion monovalent inactivated~     influenza H3N2v vaccine manufactured by Sanofi Pasteur. Subjects will be stratified by age~     (approximately 100 (up to 120) subjects 18-64 years old and approximately 100 (up to 120)~     subjects >/= 65 years old) to receive two doses of vaccine, delivered intramuscularly as~     15mcg HA/0.5mL dose, 21 days apart. The duration of the study for each subject will be~     approximately 7 months.~   "
139140|NCT01746069|"~     Smoking remains a major risk factor for chronic diseases and is a real problem for health~     systems. The use of emerging technologies, such as mobile phone , may have a important role~     in smoking cessation programs through sending reinforcement messages when patients quits~     smoking.~      Main objective: To evaluate the effectiveness of a combined 6 months smoking cessation~     program including health advice provided by a doctor and sending support messages to mobile~     phone of patients.~      Methods: Study design: Randomized single blind clinical trial. Study population: Patients~     over 18 who are willing to start a smoking cessation program, who have mobile phone, who are~     able to receive and send messages, and who have a score greater than 5 or equal to 5 on the~     Richmond scale.~      Sample size: 160 patients per arm to detect a difference in the percentage of smoking~     cessation than 10% (14.9% vs. 4.9%) between the two groups. Intervention: Experimental group:~     Health advice and support messages to mobile phone patients.~      Control group: Health advice. Assessment of the primary endpoint: At 6 months~     (positive/negative coximetry test).~      Statistical analysis: The analysis of the primary endpoint (positive / negative coximetry~     test) will be performed using logistic regression.~   "
139141|NCT01746056|"~     The goal of this study is to determine the safety and efficacy of the occlusive heat patch~     for the treatment of verrucae (warts).~   "
139142|NCT01746043|"~     The goal of this clinical research study is to compare armodafinil and minocycline when given~     alone or in combination to learn which is better for controlling side effects of~     chemoradiation treatment for esophageal cancer (such as fatigue, pain, disturbed sleep, lack~     of appetite, and drowsiness).~      Armodafinil is designed to prevent excessive sleepiness.~      Minocycline is an antibiotic, which may help to reduce multiple symptoms.~      In this study, you may receive a placebo. A placebo is not a drug. It looks like the study~     drug but is not designed to treat any disease or illness. It is designed to be compared with~     a study drug to learn if the study drug has any real effect.~   "
139214|NCT01745107|"~     The purpose of this study is to determine the efficacy of preventive intensity modulated~     radiation therapy after surgery in stage T2-3N0M0 disease of thoracic esophageal squamous~     cell carcinoma(UICC 7th edition) and to identify the subgroup benefiting from the treatment.~   "
139215|NCT01745094|"~     The purpose of this study was to evaluate the safety and efficacy of mirabegron as add-on~     therapy in patients with OAB treated with solifenacin.~   "
139143|NCT01746030|"~     This study will evaluate the prevalence of geriatric syndromes in older adults with multiple~     myeloma, examine relationships between baseline geriatrics syndromes and initial treatment~     selection, and examine risk of functional decline.~      Relationship between baseline geriatric questionnaires and initial treatment selection in~     older adults with newly diagnosed multiple myeloma.~      Feasibility of subjects completing the CARG geriatric assessments at baseline, 3 months and 6~     months.~      Comorbidities or dependence in IADLs at baseline predict decline in functional status at 6~     months of follow-up in older adults with newly diagnosed multiple myeloma.~   "
139144|NCT01746017|"~     The aim of this trial is to evaluate the safety of the study drug in healthy people and~     people with diabetes. It will investigate how much of the study drug gets into the blood~     stream and how long it takes the body to get rid of it. Information about any side effects~     that may occur will also be collected.~      The study consists of two parts. Part A will study healthy participants in up to 4 dosing~     periods over approximately 6 weeks. Part B will study participants with diabetes in up to 3~     dosing periods over approximately 5 weeks.~   "
139145|NCT01746004|"~     This study involves a single dose of 150 milligram (mg) of radiolabeled LY2157299 monohydrate~     in healthy participants. The study will determine how the body eliminates the radioactivity~     and LY2157299 monohydrate. Participants must be healthy surgically sterile or postmenopausal~     females, or sterile males. This study is approximately 8 to 15 days.~   "
139146|NCT01745991|"~     The investigators plan to invite all children in the UK with biliary atresia, treated at the~     three national centres (Birmingham, Kings College and Leeds), over a three year period to~     take part in a randomised control study. The investigators aim to determine the effectiveness~     of CoSeal® Surgical Sealant (an anti-adhesive agent) in reducing intra-abdominal adhesions~     (scar tissue) and the morbidity caused by these adhesions in children treated with a Kasai~     hepatoportoenterostomy. Adhesions are common, if not invariable, after any abdominal surgery.~     They cause intra-abdominal organs to become stuck to each other and the abdominal wall. This~     means they are no longer completely free to slide over each other. In particular patients~     have a lifetime risk that the bowel can become kinked or twisted leading to complications~     such as bowel obstruction. Adhesions also make repeat abdominal operations more difficult.~     The adhesions have to be divided in order to separate the organs from each other and the~     abdominal wall. This can lead to blood loss and increases the risk of damage to these organs.~     Anti-adhesive agents have been created to reduce the severity of these adhesions, but there~     is little in the medical literature to evaluate their effectiveness, particularly in~     children. Biliary atresia is an obliterative obstruction of the bile ducts that occurs in~     infants. Initially they are treated by an abdominal operation called a Kasai portoenterostomy~     to restore bile flow from the liver to the intestines. However approximately 40% of these~     children will go on to require a liver transplant operation in the first two years of life.~     If CoSeal® Surgical Sealant is effective this could reduce the patients lifetime risk of~     complications from abdominal adhesions and also facilitate repeat abdominal operations for~     these children, in particular for those who go on to require a liver transplant.~   "
139147|NCT01745978|"~     The aim of the present study was to compare the efficacy and safety of the knob-tipped knife~     and needle knife for precut papillotomy in difficult common bile duct (CBD)cannulation.~   "
139148|NCT01745965|"~     Trial to optimize neoadjuvant therapy for HER overexpression and co-expressing of hormone~     receptors(ER and/or PR) breast cancer (HEr2+/HR+).~      A new high potential trastuzumab conjugate T-DM1(trastuzumab was linked with the cytotoxic~     agent mertansine DM1)was tested with endocrine therapy and without against a standard arm~     with trastuzumab and endocrine therapy.~   "
139149|NCT01745952|"~     The investigators will treat patients with fully characterized refractory unifocal~     neocortical epilepsy with a technique that delivers magnetic waves (transcranial magnetic~     stimulation, TMS) to the region that causes the epilepsy. Active rTMS applied over the~     epileptogenic focus will reduce seizure frequency compared with sham rTMS.~   "
139150|NCT01745939|"~     The purpose of this study is to understand how different physical therapy interventions~     affect the use of certain abdominal muscles in patients with low back pain.~   "
139151|NCT01745926|"~     Cardiopulmonary resuscitation (CPR) is used to maintain adequate perfusion of vital organs in~     cardiac arrest patients and is fundamental for the neurological outcome and survival of these~     individuals. Unfortunately, the quality of CPR may be inadequate due largely to ineffective~     chest compressions resulting from rescuer fatigue and interruptions in compressions. The~     LUCAS device (Lund University Cardiopulmonary Assist System, Jolife, Lund, Sweden),~     introduced in 2002, is the most extensively tested and applied automated alternative to~     manual CPR for in-hospital care of cardiac arrest patients and during ambulance transfer; the~     feasibility of application of this device in helicopter emergency medical service (HEMS)~     operations, however, has never been addressed. The objective of this project is to equip the~     three active rescue helicopters in South Tyrol with the LUCAS 2 mechanical chest compression~     device to answer the question: What is the feasibility and efficiency of using this device~     for prolonged CPR in cardiac arrest patients requiring CPR during HEMS rescue operations and~     transport?~   "
139152|NCT01745913|"~     The purpose of this study is compare the efficacy of haplo-cord transplant (investigational~     arm) with that of a more commonly used procedure in which only the cells contained in one or~     two umbilical cords are infused (standard arm).~      We hypothesize that reduced intensity conditioning and haplo-cord transplant results in fast~     engraftment of neutrophils and platelets, low incidences of acute and chronic graft versus~     host disease, low frequency of delayed opportunistic infections, reduced transfusion~     requirements, shortened length of hospital stay and promising long term outcomes. We also~     hypothesize that umbilical cord blood selection can prioritize matching and better matched~     donors can be identified rapidly for most subjects.~   "
139153|NCT01745900|"~     Comparison of noninvasive glucose measurement performance versus standard invasive reference~     measurements.~   "
139154|NCT01745887|"~     This is a Phase 1b, multi-center, double-masked, randomized, placebo-controlled,~     parallel-group study designed to evaluate the safety and biological activity of two doses of~     EBI-005 ophthalmic solution versus placebo in subjects with moderate to severe Dry Eye~     Syndrome. Approximately 72 subjects will be enrolled and randomized in this study at up to 9~     centers located in the United States (US). Subjects will be enrolled in two groups or~     cohorts. The first enrollment group will consist of 33 subjects.~   "
139155|NCT01745874|"~     The purpose of this study is to determine whether whole-body MRI (WB-MRI) accuracy is~     superior to FDG-PET-CT considered as the gold-standard for the staging of distant lesions of~     rectal cancer.~   "
139233|NCT01744860|"~     This non-interventional study will compare the Cobas BRAF V600 mutation assay with in-house~     methods used in molecular laboratories for the assessment of the BRAF mutation status in~     melanoma tumor samples. No patients will be enrolled in this study. Data will be collected~     for approximately 6 months.~   "
139156|NCT01745861|"~     The incidence of acute pancreatitis in UK has risen sharply over the past 40 years. Recent~     reports suggest that 56.5 per 100 000 of the population will suffer from AP annually; this~     figure is more than double the highest previous estimated incidence. In the majority of~     patients the condition is mild, but about 25% of patients suffer a severe attack and between~     30 and 50% of these patients dies. The usual cause of death is multiple organ failure~     secondary to systemic leukocyte activation (mainly neutrophils), accompanied by the systemic~     inflammatory response syndrome (SIRS).~      Studies with omega-3 fish oil have shown to control inflammatory process and improve the~     outcome especially in hyperinflammatory conditions.~      This research will look at the effects of supplementing omega-3 fish oil to patients with~     severe acute pancreatitis (severe inflammation of the pancreas).~      Patients with severe acute pancreatitis will be prospectively and blindly randomised into~     either a study group who will receive (Lipidem, lipid emulsion contains essential fatty acids~     and omega-3 fish oil) or a control group that will receive (Lipofundin, lipid emulsion~     contains only essential fatty acids and no omega-3 fish oil). Normal and standard clinical~     care will be provided to all patients as per the national management guidelines. Each patient~     will receive either Lipidem or Lipofundin emulsions daily until they are deemed fit for~     discharge by their own medical team or for a maximum of SEVEN days.~      The main aim of this study is to examine whether lipid emulsions enriched with omega-3 fish~     oil could improve the clinical outcome in patients with severe acute pancreatitis.~   "
139157|NCT01745848|"~     Our primary hypothesis is that Roflumilast (500 μcg, once daily) will significantly decrease~     surrogate markers of bone metabolism and early cardiovascular disease in individuals with~     moderate to severe airflow obstruction and a chronic bronchitis phenotype.~   "
139158|NCT01745835|"~     comparison of the use of Colyte® (ascorbic acid mixed polyethylene glycol solution) in~     two-liter versus one-liter volume and pretreatment with bisacodyl for colonoscopy~     preparation.~   "
139159|NCT01745822|"~     Chronic hepatitis B (CHB) infection is complicated by cirrhosis and liver cancer. In~     Thailand, 7% of adults are chronically infected by Hepatitis B virus (HBV). The risk of~     perinatal transmission of HBV is about 12% when a mother has a high HBV load in her plasma,~     even if her infant receive specific immunoglobulin and vaccine.~      The hypothesis of this study is that a potent antiviral, tenofovir, can decrease HBV load in~     HBV infected pregnant women and therefore reduce the risk of perinatal transmission/ Pregnant~     women participating in this study will receive tenofovir or placebo during the last trimester~     of pregnancy and two months postpartum. The risk of perinatal transmission will be compared~     between the two groups.~      The results of the study will help define policy to manage HBV infected pregnant women to~     prevent perinatal transmission.~   "
139160|NCT01745809|"~     The purpose of this research study is to collect lung tissue and fluid from two groups of~     people: those who have severe asthma, and those who do not. These samples will then be tested~     in a laboratory to identify differences in the lung tissue cells and fluids that may exist~     between these two groups of people.~   "
139161|NCT01745796|"~     Pseudomonas aeruginosa is the main pathogen of nosocomial respiratory infections. Its~     increasing resistance to antibiotics requires the development of new strategies for~     prevention and control, demanding a better understanding of the modes of transmission and~     evolutionary dynamics of this bacteria. In patients under invasive mechanical ventilation,~     the main mode of contamination by Pseudomonas remains debated, with 3 modes of contamination~     (endogenous, crossed transmission between patients, or environmental origin) of varying~     importance, mainly depending on the endemic situation of the place of study.~      The emergence of new genotyping technologies (DiversiLab) can now facilitate studies of~     molecular epidemiology. Thanks to the multidisciplinary collaboration and innovative~     techniques, the investigators wish to study the impact of the mode of contamination on the~     outcome of ICU patients, intubated and ventilated for more than 72 hours.~   "
139162|NCT01745783|"~     This is a phase I / II for the evaluation of the safety and feasibility of intravenous~     infusion of mesenchymal cells from autologous bone marrow in patients with Multiple~     Sclerosis.~      Intravenous administration of autologous mesenchymal cells of bone marrow is feasible and~     safe and can be effective in treating patients suffering from multiple sclerosis.~   "
139163|NCT01745770|"~     The purpose of the trial is to proof whether TID 1000 mg mesalazine is non-inferior to TID 2x~     500 mg mesalazine in the treatment of patients with acute ulcerative colitis~   "
139164|NCT01745757|"~     Bevacizumab plus chemotherapy improves response rates and prolongs PFS when used as first-~     and second-line therapy for advanced breast cancer. However, bevacizumab has not improved OS~     in the individual studies currently reported. In Europe, EMEA has maintained its indication~     associated with weekly paclitaxel in first line metastatic breast cancer and more recently~     with capecitabine based on RIBBON 1 trial's results.~      The identification of patient subsets that receive the most clinical benefit would enable~     more specific treatment administration of bevacizumab and allow patients unlikely to benefit~     the opportunity to seek other treatment modalities. Unfortunately, despite efforts to~     identify patient subsets with a differential benefit from bevacizumab, no validated~     biomarkers have been defined.~      The Avastin cohort is a unique opportunity to investigate various biological and imaging~     parameters which could be related to clinical benefit of the combination of bevacizumab and~     weekly paclitaxel in first line MBC in a homogeneously treated population in French cancer~     centers. This trial will gather the expertise of several translational research platforms of~     different cancer centers from the UNICANCER consortium.~   "
139165|NCT01745744|"~     Clinical trial phase I / II, prospective, multicenter, open, randomized, parallel-groups~     controlled by two levels of dose to assess the safety and feasibility of the infusion of~     mesenchymal stem cells from adipose tissue administered intra-arterially in nondiabetic~     patients with chronic ischemia of lower limbs (CLI) and no possibility of revascularization.~   "
139216|NCT01745081|"~     Mannitol 20% has long been used to treat elevated intracranial hypertension in trauma and~     intensive care settings. More recent data indicate that hypertonic saline may be as effective~     or more effective than mannitol for this purpose, with possible fewer side effects.~      This study compares both agents in favoring cerebral relaxation during elective~     supratentorial procedures for tumor resection.~      Study hypothesis: 3% hypertonic saline will provide better cerebral relaxation with fewer~     side effects than 20% mannitol.~   "
139166|NCT01745731|"~     This is a randomized controlled trial in which the safety and feasibility of cell therapy~     medicinal product shall be measured by comparing the variables of the response after~     treatment compared to baseline prior to implementation. Secondarily the results obtained are~     compared with each of the study groups.~      Patients will receive concomitant basic pharmacological treatment for maintaining liver~     function.~      All patients will be equally medically treated. The hypothetic test is to propose mononuclear~     cells from the bone marrow infused in the territory hepatic portal remaining segments (II and~     III) to be performed while contralateral portal embolization provides progenitor cells~     hepatic regenerative capacity that would shorten the time of liver regeneration and increase~     residual volume, facilitating the realization of an extended hepatectomy with greater~     assurance of maintaining proper residual function and adequate surgical margins.~   "
139167|NCT01745718|"~     The investigators will evaluate the accuracy of performing cytological imprints of targeted~     biopsies when diagnosing prostate cancer.~      It is useful to know whether the biopsy is cancer or not, in order to know when to stop~     sampling and when to continue.~      The strategy is used in other types of cancer, e.g lung, breast etc~   "
139168|NCT01745705|"~     Cervical spine manipulation (CSM) is utilized by many health care practitioners in the~     management of patients with neck pain and headache. How CSM works is not understood however,~     most researchers agree that there is likely a combination of mechanical, neurophysiological~     and placebo effects. This study will test for possible neurophysiological effects by~     examining for changes in a person's ability to reposition their head and neck in space, and~     maintain their balance following CSM.~   "
139169|NCT01745692|"~     Ischaemic strokes (those caused by blockage in an artery in the brain caused by a blood clot)~     can be treated with very early use of clot-busting (thrombolytic) drugs to attempt to restore~     the blood supply and limit the damage, resulting in an increased proportion of people making~     a recovery to independence after stroke. However, drug treatment only succeed in restoring~     blood flow in a minority of people with clots in the larger arteries (10-25% depending on the~     size of the blood vessel) and these people also have the most severe strokes and highest risk~     of death or dependence as a result of the stroke. Current best treatment is therefore least~     effective in the group with the most severe strokes. Devices that can be fed through the~     blood vessels to either remove or break up the blood clot in the brain vessels can open this~     type of large artery blockage. However, using these devices is a highly skilled procedure and~     it takes some time both to set up the necessary facilities (including anaesthetic, nurses and~     medical support) and to reach the blockage. The extra time that is required to use these~     devices may mean that brain tissue is already irreversibly damaged. If so, then an individual~     patient cannot benefit and indeed may be harmed by opening the artery. There are no completed~     clinical trials comparing the outcome in people treated with standard stroke treatment and~     those treated with devices. PISTE is a randomised, controlled trial to test whether~     additional mechanical thrombectomy device treatment improves functional outcome in patients~     with large artery occlusion who are given IV thrombolytic drug treatment as standard care.~   "
139170|NCT01745679|"~     The aim of the study is to describe the concentrations of Ceftriaxone at the steady state, in~     patients treated for meningitis, to determine pharmacokinetic parameters at high dose in this~     population. Additionally, we aimed to detect adverse effect, especially neurological trouble~     related to Ceftriaxone toxicity.~   "
139171|NCT01745666|"~     The aim of the study is to evaluate the best stress exam to unmask long QT in patient with~     KCNQ1 or KCNH2 mutation without long QT interval in rest electrocardiogram.~   "
139172|NCT01745653|"~     Thus study consists of evaluating the effect of low level therapy on pain induced by~     insertion of an orthodontic device (the quadhelix). Each day during the first seven days~     post procedure, the level of pain will be reported on an analogic visual scale.~      As secondary objectives, intake of antalgics and type of swallowed food (soft or tough) will~     also be daily registered.~   "
139173|NCT01745640|"~     The purpose of this study is to determine the efficacy and toxicity profile of Pomalidomide~     and Dexamethasone in relapsed or refractory Multiple Myeloma patients with deletion 17p or~     translocation (4;14)~   "
139174|NCT01745627|"~     Evaluation of the safety and efficacy of the 755nm Alex laser for the treatment of benign~     pigmented and vascular lesions and scars~   "
139175|NCT01745614|"~     The objective of this study was to confirm if two formulations of nimesulide tablets are~     bioequivalent.~      Test product was Eskaflam® (Nimesulide 100 mg tablets; GlaxoSmithKline) and reference product~     Mesulid® (Nimesulide 100 mg tablets; Syntex for Productos Roche). The single dosage was one~     tablet.~      The study was prospective, open-label, randomized, crossover, single dose, with 02~     treatments, 02 sequences and 02 periods, under fasting conditions.~      The population was composed of 28 healthy volunteers, both genders, adults between 18-40~     years.~      The comparative bioavailability of the two formulations was evaluated based in statistical~     comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations~     in blood.~   "
139176|NCT01745601|"~     The objective of this study was to confirm if two formulations of escitalopram tablets are~     bioequivalent.~      Test product was escitalopram (10 mg; GlaxoSmithKline) and reference product Lexapro® (10 mg~     escitalopram; Lundbeck). The single dosage was one tablet.~      The study was prospective, open-label, randomized, crossover, single dose, with 02~     treatments, 02 sequences and 02 periods, under fasting conditions.~      The population was composed of 26 healthy volunteers, male adults between 18-50 years.~      The comparative bioavailability of the two formulations was evaluated based in statistical~     comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations~     in blood.~   "
139231|NCT01744886|"~     One-lung ventilation (OLV) during thoracic surgery and its effect on oxygen saturation has~     been discussed in multiple studies. Literature shows different ventilation strategies and~     possible hypoxemia has been attributed to several issues.~      Port-access cardiac surgical procedures (key hole surgery including mitral valve repair or~     prosthesis, tricuspid valve repair or prosthesis, atrial septal defect closure or a~     combination of these) require the use of OLV as well. Its effect on oxygen saturation has not~     been studied previously.~      The aim of this study is to investigate the effect of extracorporeal circulation (ECC) and~     patient positioning on oxygen saturation and on the progress of hypoxemia throughout OLV~     during port-access in comparison to oxygen saturation throughout OLV during lateral decubitus~     thoracotomies.~   "
139177|NCT01745588|"~     The purpose of this study is to see whether pomalidomide (also known as Pomalyst) reduces the~     number of myeloma cells in the bones, and to see what is the best way to use pomalidomide in~     patients with myeloma. To do this, the investigators want to compare two types of treatment~     using pomalidomde. This is a randomized trial which means that the decision as to which~     treatment the patient will receive will be made by a computer, much like flipping a coin.~      All patients start by receiving 4 cycles of clarithromycin, pomalidomide and dexamethasone~     (ClaPD). After 4 cycles, half of the patients will undergo an autologous stem cell transplant~     followed by pomalidomide (Group 1). The other half of the patients will continue to receive~     ClaPD for 9 cycles to be followed by pomalidomide maintenance. (Group 2).~      At the end of the study, the two groups will be compared to see if there is a difference in~     disease outcome.~   "
139178|NCT01745575|"~     The objective of this study was to confirm if two formulations of alprazolam (tablets) are~     bioequivalent.~      Test product was Zamoprax® 2 mg (GlaxoSmithKline) and reference product Tafil® 2 mg~     (Pharmacia & Upjohn). One tablet was the single dosage.~      The study was prospective, open-label, randomized, crossover, single dose, with 02~     treatments, 02 sequences and 02 periods, under fasting conditions.~      The population was composed of 26 healthy volunteers, both genders, adults between 18-50~     years.~      The comparative bioavailability of the two formulations was evaluated based in statistical~     comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations~     in blood.~   "
139179|NCT01745562|"~     The objective of this study was to confirm if two formulations of alprazolam (tablets) are~     bioequivalent.~      Test product was Zamoprax® 0.5 mg (GlaxoSmithKline) and reference product Tafil® 0.5 mg~     (Pharmacia & Upjohn). One tablet was the single dosage.~      The study was prospective, open-label, randomized, crossover, single dose, with 02~     treatments, 02 sequences and 02 periods, under fasting conditions.~      The population was composed of 28 healthy volunteers, both genders, adults between 18-50~     years.~      The comparative bioavailability of the two formulations was evaluated based in statistical~     comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations~     in blood.~   "
139180|NCT01745549|"~     During the last years, even more little needles are used for the injection of sub cutaneous~     insulin, for the diabetes therapy.~      The aim of this study is to evaluate the non inferiority of a new needle, smaller than~     another needle, in terms of hematic levels od fructosamine, an indicator of glycemic control.~   "
139181|NCT01745536|"~     This study is aimed to evaluate the use of a closed device for storage of vitrified oocytes.~   "
139182|NCT01745523|"~     This study is aimed to evaluate the use of Hydroxypropyl Cellulose (HPC) as substitute for~     the traditional protein supplement (Synthetic Serum Substitute; SSS) and Trehalose as~     substitute for the most widely used sugar (Sucrose) in the vitrification solutions employed~     for oocyte vitrification.~   "
139183|NCT01745510|"~     -  The purpose of this study is to determine whether docosahexaenoic acid is effective in~          the prevention or reducing severity of necrotizing enterocolitis (NEC) in preterm~          neonates < 1500 g at birth who are starting enteral feeding.~        -  if NEC is prevented, this study will measure whether hospital stay is also reduced in~          neonates who receive Docosahexaenoic acid (DHA)~   "
139184|NCT01745497|"~     Autism Spectrum Disorders (ASD) are characterized by difficulties in language, social~     communication, and repetitive and restricted behaviors. ASD affects as many as 1 in 90-150~     children. Sleep issues/insomnia is very common in children with ASD (50-80%). Insomnia has a~     negative impact on both the developmental and behavioral function of the child and the~     quality of life for the family. Causes of insomnia in children with ASD are multifactorial~     and can be difficult to treat effectively. Low iron stores, as manifest by low serum ferritin~     levels, is also common in children with ASD. Both insomnia and low iron stores are associated~     with Restless Legs Syndrome (RLS) and Periodic Limb Movement of Sleep (PLMS). Children with~     ASD often have difficulty communicating symptoms or tolerating Polysomnography (Sleep Study).~     This makes establishing a diagnosis of RLS or PLMS very difficult in children with ASD.~   "
139185|NCT01745484|"~     Overall objective of the study is to compare the use of SPECT in radiotherapy treatment~     planning with standard CT-based radiotherapy for stage I-III non-small-cell lung cancer~     patients~   "
139186|NCT01745471|"~     The purpose of this study is to collect data to help understand why some women develop~     Polycystic Ovary Syndrome (PCOS) associated with decreased lower-body fat.~   "
139187|NCT01745458|"~     This study is designed to assess whether inhibition of plasma Lp-PLA2 activity impacts~     platelet function as assessed by ex vivo platelet aggregation tests and in vivo plasma~     biomarkers.~   "
139188|NCT01745445|"~     This trial aims to evaluate the efficacy and safety between radiotherapy alone and concurrent~     chemo-radiotherapy after 3-4 cycles of chemotherapy in LS-SCLC.~   "
139189|NCT01745432|"~     Adhesions are the most frequent complication of abdominopelvic surgery. They are internal~     scar tissues which form as a result of surgery which may abnormally join together what were~     once separate tissues and organs.~      This study will assess the safety and usability of anti-adhesion agent (gel) when used after~     laparoscopic surgery.~      The study will enroll 30 patients, (randomised 2:1) with safety primary endpoint (adverse~     events in ADBLOCK and surgery only group) assessed at 28 days~   "
139217|NCT01745068|"~     During their lifetime, approximately 50% of Canadian women and 30% of Canadian men will~     experience at least one fracture due to bone fragility (FF). Evidence is growing regarding~     prevention programs' effectiveness to prevent falls, but prevention of fractures through fall~     prevention programs has enjoyed limited success. Falls prevention programs and post-fracture~     screening programs leading to pharmacological treatment are very different strategies, with a~     shared ultimate goal. Coordination between those who repair fractures and those who manage~     the patient to prevent the next fracture is critical. The overarching aim of this proposal is~     to generate evidence-based knowledge about the effectiveness and cost-effectiveness of an~     integrated FF prevention program, as well as a portrait of the barriers and facilitating~     factors for such programs. More specifically, the objectives are: 1) to combine existing fall~     prevention and post-fracture management programs in the province of Quebec into integrated FF~     prevention programs; 2) to compare the performance of these integrated programs to control~     sites, using a pragmatic study design; 3) to identify barriers as well as factors that~     improve effectiveness across different implementation milieu; and 4) to develop and engage in~     active knowledge transfer activities in Quebec regions where integrated FF prevention~     programs are neither adequately nor successfully implemented. Drawing upon the literature on~     integrated healthcare, fall and fracture prevention, we hypothesize that an integrated FF~     program can reduce the risk of a subsequent fracture by at least 30% in the population of~     interest. The proposed team is poised to develop new interdisciplinary collaborations among~     healthcare practitioners and decision makers involved in the prevention of FFs. The program~     is built upon existing healthcare and structures and programs and in turn, will truly measure~     the effectiveness of an integrated FF prevention program. The results will ultimately lead to~     improvements in the existing knowledge base, address policy-relevant and health systems~     problems, and assist in the design and implementation of FFs prevention programs.~   "
139190|NCT01745419|"~     Chronic obstructive pulmonary disease (COPD) is a common disease in smokers. COPD has a~     slowly deteriorating course, punctuated by exacerbations- acute events characterized by~     increasing shortness of breath and putrid sputum. Exacerbations of COPD may be precipitated~     by several factors, most commonly infections.~      Exacerbation frequency generally increases with declining lung function. However, some~     patients with COPD consistently experience a higher rate of exacerbations than others despite~     similar severity of COPD. This has led researchers to postulate the existence of a distinct~     subgroup of frequent exacerbators . Recent work has also brought attention to a subset of~     patients who experience remarkably few exacerbations despite significantly impaired lung~     function. Careful characterization of both of these extreme subgroups of COPD may offer~     additional insights into why certain patients are prone to frequent exacerbations while~     others remain relatively protected.~      Haptoglobin (Hp) is a protein produced predominately by the liver . In humans two types of~     genes for Hp exist (1 and 2) with possible combinations of these two genes- 1-1, 1-2, or 2-2.~     The Hp 2 gene is believed to have arisen from the Hp 1 gene in human evolution. Subsequently~     the prevalence of the Hp 2 allele has spread throughout the world, probably as a result of~     its ability to provide a selective advantage against infectious disease. The Hp 1-2~     combination is a very common one. In most western countries, the prevalence of the Hp~     genotypes is 16% Hp 1-1, 36% Hp 2-2 and 48% Hp 2-1.~      The Hp gene form has been shown to be associated with disease. Specifically, Hp phenotypes~     have been found to affect propensity to atherosclerosis in Diabetic individuals. There have~     been several studies suggesting that the Hp 2-2 phenotype is associated with a protection~     against infectious complications.~      In view of the importance of respiratory infections on COPD exacerbations, and of the gained~     knowledge of Haptoglobin subtypes on propensity to infection, we propose to investigate~     whether Haptoglobin subtypes are in correlation with the frequent exacerbator phenotype of~     COPD. We postulate that, since people with Hp 1-1 are more prone to infection, the frequency~     of the Hp 1-1 phenotype will be higher in frequent exacerbators of COPD than in non-~     exacerbators.~      To test our hypothesis we propose to determine Hp phenotype in two groups of COPD patients:~     one with frequent exacerbations and one with no exacerbations, and compare the relative~     frequency of the 1-1 phenotype in the two groups.~   "
139191|NCT01745406|"~     When a patient is admitted to the ICU this often happens so suddenly that this can create a~     significant amount of stress and anxiety for family members for several reasons. Firstly, the~     family does not have a pre existing relationship with the ICU team. Secondly, the urgency of~     the situation and the technic it requires is often such that minimal information can be given~     to family members. And finally, as a result of the unpredictability of each patient's~     condition, it can be difficult to predict outcome for family members. Together, these factors~     compound the stress and anxiety of family members. This anxiety is natural and it is~     important for health caregivers to be able to offer the best support possible. A high quality~     communication provided by structured information given by physicians and nurses as well could~     improve support to the families and lead to greater satisfaction.~      Giving information to families during meetings is crucial at 3 moments: at the first day when~     the patient is admitted, at day 3, weekly and each time important news is given (surgery,~     deterioration in condition, end-of-life).~      The purpose of this project is to evaluate if the involvement of nurses during those meetings~     could improve quality in communication which is assessed by mixed methods. Families and~     healthcare workers satisfaction will be assessed by qualitative methodology. Family~     peritraumatic stress, symptoms of anxiety and depression and PTSD will be assessed using~     validated scales.~      Training of healthcare workers will be done by role play. Information to the families is~     delivered using a framework for physicians and nurses. All the meetings of the study will be~     audited by a psychologist.~   "
139192|NCT01745393|"~     The study's primary aim is to test the hypothesis that an intervention integrating pediatric~     clinic-level quality improvement with home-level behavioral counseling (CQI+BC) will result~     in greater reductions in child cotinine (a biomarker of secondhand smoke exposure) and~     reported cigarettes exposed/day than a clinic-level quality improvement plus attention~     control intervention (CQI+A). A secondary aim is to test the hypothesis that relative to~     CQI+A, CQI+BC will result in higher cotinine-verified, 7-day point prevalence quit rate among~     parents.~   "
139193|NCT01745380|"~     The purpose of this study is to compare the efficacy of Kovacaine Mist, and Placebo for~     inducing pulpal anesthesia of the maxillary teeth in adults.~   "
139194|NCT01745367|"~     This is a phase 2 multicenter, double-blind, randomized, placebo-controlled, two-arm study~     for subjects with locally recurrent or metastatic triple negative breast cancer.~      Patients will be randomized 2:1 to either tivozanib hydrochloride and weekly paclitaxel or~     placebo and weekly paclitaxel.~      Subjects will be stratified based on Eastern Cooperative Oncology Group (ECOG) performance~     score (0 vs 1) and line of treatment (first vs second).~      All subjects will be evaluated for progression free survival and overall survival as well as~     safety and tolerability. Biomarker and pharmacokinetic (PK) analysis are also included in~     study. This study will determine whether tivozanib hydrocholoride combined with weekly~     paclitaxel improves clinical outcomes in patients with triple negative breast cancer.~   "
139195|NCT01745354|"~     For patients with lymphoma that recurs after chemotherapy, bone marrow transplantation using~     cells from a healthy donor represents potentially curative treatment. In these individuals,~     cure is possible because transplantation of healthy donor immune cells can fight the lymphoma~     in the patient. The goal of this work is to test a strategy that activates the healthy donor~     immune cells so that they more effectively fight lymphoma and can result in an increased cure~     rate for these patients. Our group has previously studied CpG, an immune activating~     medication, in patients with lymphoma and demonstrated modest anti-tumor responses. We now~     have a more potent form of CpG which we intend to test to see if it will better activate the~     donor immune cells and result in shrinkage of tumor throughout the entire body, not just at~     the injected site.~   "
139196|NCT01745341|"~     The purpose of this study is to determine if apnea (the stopping of breathing) occurs in~     patients undergoing undergoing monitored anesthesia care (MAC) for vitreoretinal surgery~   "
139197|NCT01745328|"~     Traditional Chinese Medicine (TCM) could be used to treat Recurrent urinary tract infection~     (RUTI).~   "
139198|NCT01745315|"~     There are many instruments with different energy modalities or with different properties that~     are available for use in total laparoscopic hysterectomy. The aim of the present study is to~     compare three of these instruments that are present in our clinic - HALO PKS Cutting Forceps,~     LigaSure and Enseal Tissue Sealer, in total laparoscopic hysterectomy with respect to~     operation time, blood loss, change in hemoglobin / hematocrit levels, perioperative~     complications, return of gastrointestinal activity and hospitalization time.~   "
139199|NCT01745302|"~     The investigators performed a randomized, double-blind controlled, prospective study method~     on observation of Traditional Chinese Medicine combined with targeted therapy to prolong the~     efficacy of long-term survival of advanced pulmonary Adenocarcinoma patients.The~     investigators plan to involve 404 cases for observation in 3 years (202 cases for each~     group), expecting that integrated TCM combined with targeted therapy has a better efficacy on~     prolonging progression-free survival time, overall survival, improving QOL of patients than~     that of targeted therapy.~   "
139200|NCT01745289|"~     The LATTE study is an extension study to the now closed Arimidex, Tamoxifen Alone or in~     combination (ATAC) trail that took place 10 years ago. LATTE aims to collect long term~     follow-up information since the conclusion of ATAC, and for at least another 5 years,~     regarding: Additional efficacy data (first local recurrence, first distant recurrence),~     Additional safety data (ischaemic cardiac and cerebrovascular event, fractures), and Cause~     specific mortality and new primary cancers.~      The LATTE study will pick up where ATAC left off to follow a number of post-menopausal women~     with breast cancer who were randomised to receive either anastrozole or tamoxifen in the ATAC~     Trial and not known to have died or withdrawn consent before April 1st 2009. Since ATAC was a~     nationwide study, the women of LATTE will also reside and receive their follow-up care in~     various areas of the country. There will not be any vulnerable groups participating in this~     study.~      Patient interaction will consist on in person interviews at designated follow-up times and/or~     telephone interviews. Data will be collected at point of contact, whether that is in person~     at the clinic site or over the telephone. Telephone interviews will be completed in LATTE~     study offices. Topics of focus for data collection consists of: whether or not there is a~     suspected recurrence, new breast primary tumour, new other primary tumour, ischaemic cardiac~     event, cerebrovascular event, or a serious fracture. Since the follow-up questions are short~     in detail, respondent burden time should be less than 1 hour in most cases.~   "
139201|NCT01745276|"~     The purpose of this study is to evaluate the relative osseomechanical strength of a novel~     coated pin/screw in a clinical model.~   "
139202|NCT01745263|"~     The European population is aging rapidly which poses a challenge on the individual, the~     European societies, and health care systems. Among the most promising public health~     interventions that may extend healthy life expectancy at older age are vitamin D, marine~     omega-3 fatty acids and physical exercise. However, their individual and combined effects~     have yet to be confirmed in a clinical trial.~      The broad aim of DO-HEALTH is to prolong healthy life expectancy in European seniors. The~     specific aim is to establish whether vitamin D, omega-3 fatty acids, and a simple home~     exercise program will prevent disease at older age.~      To achieve these aims, DO-HEALTH will enroll 2152 community-dwelling men and women who are 70~     years and older, an age when chronic diseases increase substantially. The DO-HEALTH seniors~     will be recruited from 7 European cities (Zurich, Basel, Geneva, Toulouse, Berlin, Innsbruck~     and Coimbra) and will be randomized in a 2x2x2 factorial design trial to a simple home~     exercise program and/or vitamin D, and/or omega-3 fatty acids, over a 3 year period. This~     will allow to test the individual and the combined benefit of the interventions in the~     prevention of 5 primary endpoints: the risk of incident non-vertebral fractures; the risk of~     functional decline; the risk of blood pressure increase; the risk of cognitive decline; and~     the rate of any infection. Key secondary endpoints include risk of hip fracture, rate of~     falls, pain in symptomatic knee osteoarthritis, gastro-intestinal symptoms, mental and oral~     health, quality of life, and life-expectancy.~      All clinical endpoints will be supported by a large DO-HEALTH biomarker study to evaluate the~     effect of the interventions at the cellular level of multi-organ function. DO-HEALTH will~     further evaluate reasons why or why not seniors adhere to the 3 interventions, and will~     assess their cost-benefit in a health economic model based on documented health care~     utilization and observed incidence of chronic disease.~      website DO-HEALTH: http://do-health.eu/wordpress/ website EC:~     http://ec.europa.eu/research/health/medical-research/human-development-and-ageing/projects/do~     -health_en.html~   "
139203|NCT01745250|"~     The purpose of this study is to demonstrate the efficacy and safety of Emervel Lips and~     Juvederm Ultra smile~   "
139204|NCT01745237|"~     The primary objective of this study was to determine the ability of cardiac magnetic~     resonance (CMR) to identify cardiac involvement in patients with sarcoidosis. Patients were~     to undergo CMR in addition to routine clinical evaluation.~   "
139205|NCT01745224|"~     This proof of concept study will be conducted to assess the aesthetic improvement in~     refractory mixed type melasma in subjects treated with two FDA 510K approved devices: Q~     Switched Nd: YAG Laser vs. Alex TriVantage~   "
139206|NCT01745211|"~     Evaluate the safety and efficacy of the bilateral treatment of striae using a 755nm~     Alexandrite laser.~   "
139207|NCT01745198|"~     In a retrospective analysis of data from 1100 patients, disease-delaying effects of~     Cerefolin®/CerefolinNAC® were examined in terms of cognition. The purpose of the current~     study is to expand the retrospective study dataset by prospectively collecting additional~     biomarker and imaging data.~   "
139208|NCT01745185|"~     This study is a prospective active comparator study to assess the immune response elicited by~     human recombinant agalsidase therapy in subjects who are switching from agalsidase alfa to~     agalsidase beta with Fabry disease. Fabry disease is an X-linked lysosomal storage disorder,~     due to deficient alpha-galactosidase A activity. The progressive accumulation of~     globotriaosylceramide (GL-3) in the lysosomes of the vascular endothelial cells of multiple~     organ systems like the kidneys, heart, skin, and brain, leads to a microvascular disease. In~     Fabry disease, nephropathy dominates and renal function impairment occurs as a result of~     accumulation of GL-3 in renal cells~   "
139209|NCT01745172|"~     This is a pilot study to assess the effectiveness, safety and feasibility of carotid body~     removal in patients with high blood pressure (hypertension) resistant to medical treatment.~     Patients with high blood pressure are at significant risk of medical complications including~     stroke and heart disease. The principle research question is whether removal of the carotid~     body will lead to an improvement in the blood pressure of this patient group.~   "
139210|NCT01745159|"~     To assess if proactive, 2 times-weekly application of tacrolimus ointment can extend~     remission time to relapse and reduce the incidence of disease exacerbation (DE) in paediatric~     patients over a period of 6 months.~   "
139211|NCT01745146|"~     The present study addresses problematic anger and irritability in community dwelling persons~     with traumatic brain injury (TBI). It is designed to test the worth of a novel treatment~     approach called Anger Self-Management Training (ASMT), compared to a treatment offering~     supportive therapy focused on personal readjustment and education, the PRE (Personal~     Readjustment and Education). The project is a 3-center randomized controlled trial employing~     equivalent therapist time and therapeutic structure in the delivery of treatment options. The~     overall aim is to evaluate the relative response rate and correlates of treatment response~     for the ASMT as compared to the PRE.~   "
139212|NCT01745133|"~     The purpose of the study is to investigate if combined use of OLUX-E™ Foam and SORILUX Foam~     may help maintain the therapeutic benefit that is achieved with OLUX-E™ Foam in the~     treatment of moderate plaque psoriasis.~      OLUX-E™ is a medication that contains a corticosteroid delivered in a foam formulation.~     SORILUX Foam is a foam formulation of calcipotriene. Both medications have been approved by~     the FDA for treating plaque psoriasis.~   "
139232|NCT01744873|"~     This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single~     dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence~     between Test Product and the corresponding Reference Product under fed condition in normal,~     healthy, adult human subjects.~   "
139220|NCT01745029|"~     The purpose of this study is to describe gastrointestinal (GI) motility in patients suffering~     from severe Ulcerative Colitis (UC) and to compare these results with similar results~     obtained in remission.~      The study is done with the use of Motilis 3D-Transit system which consists of a small~     electronic capsule ingested and detected by a receiver carried by the patient. Position and~     orientation of the capsule are interpreted by dedicated computer software and transit times,~     progression velocity and contraction frequencies can be revealed.~      The study is mainly descriptive and is designed to test and evaluate the usefulness of the~     Motilis 3D Transit system in UC patients and to tell investigators more about GI motility~     during and after severe inflammation.~      Motilis 3D-Transit system gives investigators a unique chance to study the gastrointestinal~     canal as a whole during and after severe illness.~      The investigators expect to include 20 patients suffering from severe UC admitted to Hospital~     with the purpose of getting medical treatment. The investigators do not expect any drop out,~     but in case of drop out a new patient will be included.~   "
139221|NCT01745016|"~     Beta-alanine, as a method to increase muscle carnosine, has been shown to enhance muscle~     buffering capacity and delay fatigue. Various fatigue tests have been utilized to examine the~     effectiveness of beta-alanine supplementation. The physical working capacity test has been~     used to show significant increases in physical working capacities following supplementation.~     The physical working capacity tests were originally developed by Moritani et al. 1981 and~     Devries et al. 1982 to measure the point of onset of muscular fatigue. It is hypothesized~     that beta-alanine will increase physical working capacity at heart rate threshold, thereby~     signifying a delay in fatigue.~   "
139222|NCT01745003|"~     The main goal of this Collaborative Proposal is to investigate biochemical, functional, and~     structural neuroimaging changes following non-invasive brain stimulation in patients with~     chronic widespread pain: fibromyalgia (FM). The fact that multiple therapeutic modalities~     which focus on central mechanisms provide modest relief for these patients raises the~     possibility that the cause for the chronicity of this debilitating disorder may lie within~     the brain itself. We propose that changes in the cortical milieu may result from prolonged~     experience of pain and suffering. Our previous results suggest changes in excitatory~     neurotransmitter levels, connectivity between multiple brain networks, and cortical thickness~     coincide within central neural loci related to pain perception and modulation in FM.~     Interestingly, modulation of cortical activity can be achieved noninvasively by a novel tool,~     transcranial direct current stimulation (tDCS), which has been reported to produce lasting~     therapeutic effects in chronic pain, especially FM. We propose to study the long-term effects~     of tDCS application on multiple levels of the central nervous system in FM patients. This~     project has significant clinical relevance and has the support of collaborators from~     University of Michigan and Harvard University~   "
139223|NCT01744990|"~     The aim of this study is to identify, based on standardized food provocation tests, which~     nuts allergic patients need a selective, or a complete dietary eviction of all kind of nuts~     (nuts being defined as peanut, all tree nuts, pine nut and sesame). The investigators~     postulate that predictive factors of multiple nut allergy are high specific immunoglobulin E~     level, positive skin tests and/or clinical markers, such as atopic dermatitis, presence of~     other food allergies or a history of a severe previous reaction~   "
139224|NCT01744977|"~     The purpose of the overall study is to improve medication use rates among veterans by looking~     at the risk factors of low-density lipoprotein cholesterol (LDL). It will involve patients~     who have high LDL-C level (<130mg/dl) and /or may have difficulty taking their medications~     based on how often they refilled their medications in the last 12 months.~      The investigators will test an innovative adherence packaging relative to usual care. The~     primary hypothesis is that veterans who receive the intervention will have greater~     improvement in their medication adherence as measured by pill refill at 6 and 12 months of~     follow up as compared to the control group.~   "
139225|NCT01744964|"~     The aims of this study were to assess the effects of the dopamine agonist apomorphine on~     experimental pain models in healthy subjects and to explore the possible association between~     these effects and a common polymorphism within the dopamine transporter gene.~   "
139226|NCT01744951|"~     This study seeks to pilot a manualized adoption-specific intervention aimed at providing a~     preventive intervention for families adopting children ages 5-14 years where family~     reunification has been terminated and the family is moving toward adoption or who have~     adopted children from foster care in the last three years. This work will fill a major gap in~     services to children and families and is developed to improve mental health and family~     functioning of children adopted from foster care, as well as decrease adoption disruptions.~     President Clinton's 1997 adoption initiative, The Adoption and Safe Families ACT (ASFA),~     along with subsequent Congressional initiatives, have provided incentives to States and~     subsidies for adopting older children with a resultant increase in rates of adoption from~     foster care from 26,000 in 1995 to 53,000 (stabilized annual rate) beginning in 2002. The~     mean age at adoption from foster care is now 6 years old. These older children have histories~     of physical and sexual abuse, neglect, and multiple placements, all factors that predict~     behavior problems over time. To address this gap in our knowledge of providing care for this~     vulnerable group, we have developed a manualized adoption-specific intervention for families~     adopting children from foster care. Because adoptive children generally enter homes with~     stable, well-functioning parents, interventions may be particularly effective in helping the~     children adjust and their parents learn to understand and manage children with difficult past~     histories.~      The aim of this current pilot trial is to test this intervention designed to improve the~     outcomes for children adopted from foster care through a randomized trial. Our hypothesis is~     that this manualized adoption-specific intervention will be more effective than care as usual~     in improving child mental health and family functioning outcomes; specifically, families and~     children who have been randomized to the manualized adoption-specific intervention will show~     better outcomes on the post-treatment measures and the 3 month follow-up than on the~     pre-treatment measures than the care as usual families and children.~   "
139227|NCT01744938|"~     Patients with the lower malignant obstructive jaundice planned to do the~     pancreaticoduodenectomy, receiving preoperative biliary drainage or early surgery (without~     preoperative biliary drainage), both groups has the similar surgical morbidity, no statistics~     significance.~   "
139228|NCT01744925|"~     This study is designed to evaluate the safety and efficacy of icotinib at routine dose and~     higher dose as second-line treatment in non-small cell lung cancer patients with epidermal~     growth factor receptor of wild type.~   "
139229|NCT01744912|"~     The purpose of this study is to determine whether ublituximab in combination with~     lenalidomide (Revlimid®) is safe and effective in patients with B-Cell Lymphoid Malignancies~     who have relapsed or are refractory after CD20 directed antibody therapy~   "
139230|NCT01744899|"~     The purpose of this study was to examine the effect of prolonged sitting duration and three~     different sitting postures (erect, slumped, and slouched sitting postures) on spinal nerve~     root function by measuring the soleus (SOL) H-reflex amplitude. In addition, the pressure~     under the ischial tuberosities during the three sitting postures were assessed and correlated~     with the SOL H-reflex amplitude.~   "
139234|NCT01744847|"~     In patients with pancreatic duct cannulation initially by chance, double guide wire technique~     and trans pancreatic sphincterotomy facilitate biliary cannulation and show the similar~     success rates. The incidence of post-procedure pancreatitis was similar in the two groups,~     but post-procedure hyperamylasemia was significantly higher in the DGT group.~   "
139235|NCT01744834|"~     Overall goal of this study is to scrutinize the relation of learning behavior and related~     brain activity to the development of alcohol use disorder (AUD).~      The researchers aim is to characterise a representative sample (200 men at age 18) with~     regard to learning parameters and their respective neural correlates which are thought to be~     indicators for the risk to develop an alcohol use disorder.~      As part of a large multi-center study on alcohol dependency (in Dresden & Berlin, Germany)~     the researchers will characterize the sample and then prospectively assess alcohol~     consumption and development of AUDs over a period of three years.~      Among other hypotheses it is expected that increased activation of striatal and prefrontal~     brain regions by the Pavlovian-to-instrumental transfer process is related to increased risk~     of developing an AUD.~   "
139236|NCT01744821|"~     The purpose of this research is to study Vitamin D3 replacement for patients at high risk of~     developing ovarian, fallopian tube, or peritoneal cancer, and see if the Vitamin D3~     replacement may be able to prevent the cancer.~      This study is being done because in the United States ovarian cancer is the leading cause of~     death among women with gynecologic cancer. Women with BRCA mutations, a personal history of~     breast cancer, and a family history of breast and ovarian cancer are at high risk of~     developing ovarian, fallopian, and primary peritoneal cancer. Novel treatments other than~     surgery which can decrease the risk of developing ovarian, fallopian tube, and primary~     peritoneal cancer are important. Vitamin D has been shown to reduce the risk of developing~     bladder, breast, colon, endometrial, esophageal, gallbladder, gastric, lung, pancreatic,~     prostate, rectal, renal, vulvar and Hodgkin and non-Hodgkin lymphoma, and it may play a role~     in the prevention of ovarian cancer.~   "
139237|NCT01744808|"~     To investigate whether there is a food-effect with oral administration with EB-1020 as well~     as to obtain information on the safety, and tolerability of EB-1020 in a range of doses.~   "
139238|NCT01744795|"~     Minimal invasive monitoring systems of central hemodynamics are gaining increasing~     popularity. The present study investigates the precision of the esophageal doppler (CardioQ)~     derived cardiac output and its agreement with pulmonary artery catheter thermodilution (PAC~     TD) for measuring CO during steady state and with induced hemodynamic changes in patients~     scheduled for elective cardiac surgery.~   "
139239|NCT01744782|"~     This was a long-term, open-label study of the safety, tolerability and effectiveness of RP103~     in cystinosis patients who were naïve to any form of cysteamine treatment. Participants~     received RP103 treatment for at least 12 months. U.S. participants transitioned to the~     commercially approved drug PROCYSBI®. In Brazil, after at least 12 months of study~     participation and upon approval by the Brazilian regulatory authorities, participants were~     eligible to transition to a post-study drug supply program, and continue to receive the drug~     at no personal cost.~   "
139240|NCT01744769|"~     1. The incidence of differentiated thyroid cancer is increasing in Korea. A significant~          number of them experience severe hypothyroidism in preparation for radioactive iodine~          (RAI) therapy after total thyroidectomy.~        2. Because the function of thyroid hormone is closely linked with lipid and glucose~          metabolism, overt hypothyroidism after thyroid hormone withdrawal during RAI therapy may~          induce the changes of metabolic parameters.~        3. We investigate the effects of thyroid hormone withdrawal on metabolic and cardiovascular~          parameters during radioactive iodine therapy in differentiated thyroid cancer.~   "
139241|NCT01744756|"~     A study to research whether subconjunctival bevacizumab injection may potentially suppress~     neovascularization in pterygium, retarding and decreasing the size of recurrent pterygium.~   "
139242|NCT01744743|"~     To assess the effect of universal preconception hypothyroidism for maternal pregnancy~     outcome, and 0-3yrs offspring neurocognitive ability and IQ score.~   "
139243|NCT01744730|"~     The purpose of this study is to better understand how clindamycin works in children who fall~     in the 85th percentile or higher for body mass index (BMI - a ratio of weight to height). The~     results of the study will help better understand if children in higher BMI ranges process the~     medication differently and whether dosing should be adjusted in these children.~   "
139244|NCT01744717|"~     Pain is an unpleasant and important stress factor, and a potentially harmful experience for~     critically ill patients. Pain is harder to evaluate in non-communicative patients, who can´t~     report their own pain. Behavioral indicators have been proved as useful and reliable for~     detecting and measuring pain in these patients, and have been the basis for constructing~     scales for measuring pain, such as the Behavioural Pain Scale (BPS), the Critical Care~     Observation Tool (CPOT) and the Scale of Behaviors Indicating Pain (ESCID) .~      The BPS and ESCID were tested in a study with a sample of 42 critically ill patients in~     Spain, showing good validity and reliability.~      The objective of this Spanish multicentre study is to test the validity and reliability of~     the ESCID scale in a large sample of critically ill patients with medical and postsurgical~     pathology for the detection and measurement of pain.~   "
139245|NCT01744704|"~     The primary objective of this study is to assess the safety and tolerability of single and~     multiple ascending doses of rhNGF when administered as eye drops in healthy subjects.~   "
139246|NCT01744691|"~     An Open-label, Single arm, Multicenter Phase 2 Study of the Bruton's Tyrosine Kinase~     Inhibitor ibrutinib in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia or~     Small Lymphocytic Lymphoma with 17p Deletion~   "
139265|NCT01744444|"~     Different treatment trials have been published in acquired nystagmus in the last decade;~     gabapentin and memantine have been found to be efficient in treating pendular nystagmus in~     Multiple Sclerosis. The effects of treatments are measured on nystagmus velocity, amplitude,~     frequency and on visual acuity. None of the trials measured a functional visual score or~     oscillopsia score.~      The aim of our study is to evaluate the effect of gabapentin and memantine on the mean~     velocity, amplitude and frequency of pendular nystagmus, as well as on oscillopsia, visual~     acuity and vision-specific health-related quality of life score, in 10 patients with multiple~     sclerosis. The primary object is to find out the best variable to evaluate the efficiency of~     nystagmus treatment and the secondary, to compare the efficiency of both gabapentin and~     memantine in a common population of patients.~   "
139247|NCT01744678|"~     The purpose of this study is to validate the acceptability, operational feasibility and~     efficacy of a combined fatigue countermeasure comprised of shorter-wavelength light and~     exercise during operational Orbit 1 night shifts to improve alertness and performance of~     flight mission controllers.~      Specifically, the investigators will:~        1. Feasibility. Test the feasibility of developing a break room containing fatigue~          countermeasures (shorter-wavelength light and exercise equipment) to be used by flight~          mission controllers during Orbit 1 night shifts, and the feasibility to schedule regular~          breaks during the Orbit 1 shift so that flight mission controllers have the opportunity~          to use the fatigue countermeasures break room.~        2. Acceptability. Test the acceptability of the use of the fatigue countermeasures break~          room evaluating when and how the room is used by flight mission controllers, as measured~          on End-of-Shift Productivity Questionnaire.~        3. Test the hypothesis that alertness and performance will be impaired in flight mission~          controllers during Orbit 1 operational night shifts as compared to flight mission~          controllers working a non-console day shift.~        4. Test the hypothesis that alertness and performance of flight mission controllers who~          exercise and are exposed to shorter wavelength light during the Orbit 1 night shift will~          be significantly more alert and have better mood, performance (e.g., less PVT lapses,~          increased productivity) than those same mission controllers working Orbit 1 night shifts~          without exposure to the shorter wavelength light and exercise.~        5. Test the acceptability, operational feasibility and efficacy of implementing an~          anonymous sleep disorders screening for flight controllers, evaluated by number of~          visitors to the screening web site and the number of completed assessments.~   "
139248|NCT01744665|"~     To evaluate molecular relapse free rates 6 months after stopping nilotinib therapy in~     patients who achieve MR4.5~   "
139249|NCT01744652|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of dasatinib and crizotinib that can be given to patients with advanced cancer.~     The safety of this drug combination will also be studied.~      Dasatinib is designed to block certain proteins from causing cancer cells to grow out of~     control. This may cause the cancer cells to die.~      Crizotinib is designed to block certain abnormal genes found in cancer cells. This may cause~     the cancer cells to die.~      This is an investigational study. Dasatinib is FDA approved and commercially available for~     the treatment of leukemia. Crizotinib is FDA approved and commercially available for the~     treatment of lung cancer. The combination of dasatinib and crizotinib is currently being used~     for research purposes only.~      Up to 176 participants will take part in this study. All will be enrolled at MD Anderson~   "
139250|NCT01744639|"~     Number of shows: 20 patients Track: A month with three visiting Intervention: Nutritional~     assessment including anthropometry, bioelectrical impedance, biochemical tests, Psychometric~     Hepatic Encephalopathy Score and Critical Flicker Frequency.~   "
139251|NCT01744626|"~     This is a dose finding study using a 3 + 3 dose escalation and expansion design to determine~     a Not Tolerated Dose (NTD), Optimal Biological Effect Dose (OBE) and / or Maximum Tolerated~     Dose (MTD). These data will be used to establish a Recommended Phase 2 Dose (RP2D) for the~     combination of CC-292 and Rituximab in subjects with CLL.~   "
139252|NCT01744613|"~     Antiplatelet therapy with clopidogrel is recommended following peripheral endovascular~     procedures. The clinical significance of an inadequate response to clopidogrel following~     percutaneous coronary interventions has been recently recognized.This study was designed to~     investigate platelet responsiveness to Clopidogrel following endovascular therapy of~     peripheral arterial disease using the VerifyNow P2Y12 point-of-care testing and to determine~     the optimal P2Y12 reactive unites (PRU) cut-off value of platelet inhibition influencing~     outcomes of infrainguinal angioplasty or stenting in patients receiving clopidogrel~     antiplatelet therapy.~   "
139253|NCT01744600|"~     The study is a cluster randomised control trial, which aims to investigate the effectiveness~     of music therapy in minimising Behavioural and Psychological Symptoms of Dementia (BPSD) in~     older adults with dementia. In particular, the study aims to identify the main components of~     music therapy that are key in achieving this. The study will also explore carers' perceptions~     of music therapy, and investigate whether carers become more attentive to patients' needs and~     more able to manage patients' BPSD as a result of the music therapy programme.~   "
139254|NCT01744587|"~     The purpose of this study is to investigate the EBV reactivation rate in post-radiation and~     remission NPC patients, evaluate the safety and tolerance of EGCG and analyze the~     observational correlation between EBV reactivation and clinical outcome.~   "
139255|NCT01744574|"~     Data suggest that progesterone may improve smoking cessation outcomes perhaps by reducing~     impulsive behavior. However, the clinical literature on this topic is lacking. Therefore, in~     Project I we are proposing a double-blind randomized controlled trial to assess the role of~     exogenous progesterone on impulsivity and smoking cessation in a sample of males and females~     who are motivated to quit smoking.~   "
139256|NCT01744561|"~     Physical activity and exercise have become an accepted and valued component of Cystic~     Fibrosis care. Regular physical activity and exercise can slow the rate of decline of~     pulmonary function, improve physical fitness, and enhance quality of life. However,~     motivating people to be more active is challenging. Supervised exercise programs are~     expensive and labor intensive, and adherence falls off significantly once supervision ends.~     Unsupervised or partially supervised programs are less costly and more flexible, but~     compliance can be more problematic. The primary objective of this study is to evaluate the~     effects of a 12-months partially supervised exercise intervention along with regular~     motivation on forced expiratory volume in 1 second (FEV1) in a large international group of~     cystic fibrosis patients. Secondary endpoints include patient reported quality of life, as~     well as levels of anxiety and depression, and control of blood sugar. A total of 292 patients~     with cystic fibrosis 12 years and older with a FEV1 ≥35% predicted will be recruited.~     Following baseline assessments (2 visits) patients will be randomized into an intervention~     and a control group. Thereafter, they will be seen every 3 months for assessments in their~     centre for one year (4 follow-up visits). Along with individual counseling to increase~     vigorous physical activity by at least 3 hours per week on each clinic visit, the~     intervention group will document daily exercise and inactivity time and will receive a step~     counter and they will record their progress with a web-based program. They will also receive~     monthly phone calls from the study staff. After 6 months, they will continue with the step~     counter and web-based program for a further 6 months. The control group will receive access~     to this intervention after 12 months of standardized care. Should this relatively simple~     program prove successful, this will be made available on a wider scale internationally.~   "
139266|NCT01744431|"~     Can thrombin generation measurement predict the risk of venous thromboembolism in acute ill~     patients~      Traditional coagulation tests do not assess the whole coagulation system. Thrombin generation~     assays measure the ability of plasma sample to generate thrombin following in vitro~     activation of coagulation. In contrast to the classical clotting assays, thrombin generation~     reflects and integrates all pro and anticoagulant reactions that regulate the formation and~     inhibition of thrombin.~      The aim of our study is to investigate whether thrombin generation would be able to predict a~     hypercoagulable state in acute ill patients admitted in the internal medical departments and~     how it correlates with the Padua prediction score, a score that could assists the risk for~     venous thromboembolism in hospitalized medical patients.~      In total 300 patients are planned for inclusion in this trial. After signing an informed~     consent a blood sample will be obtained from each participant. We will measure the thrombin~     generation over time in plasma assessed by the calibrated automated thrombogram (CAT).~   "
139257|NCT01744548|"~     This study aims to evaluate the feasibility, acceptability and efficacy of transdiagnostic~     Cognitive Behavioural Therapy (tCBT) in comparison to delayed-treatment for depression and~     anxiety in older people. CBT is a form of 'talking therapy' that has been recommended by the~     National Institute of Clinical Excellence for the treatment of mood disorders. While~     traditional disorder-specific CBT has been found to be effective at alleviating individual~     mood disorders, it may be less effective when multiple mood disorders are present (i.e. when~     there is psychological comorbidity). tCBT is a form of CBT that targets cognitive and~     behavioural processes common to a range of mood disorders. Consequently, it may be better~     placed to address comorbidity than traditional CBT, both in terms of clinical and~     cost-effectiveness.~      There is growing evidence that tCBT has beneficial effects on both depression and anxiety in~     working-age people. However, the potential benefits of this approach have not yet been~     examined in older people (in whom psychological comorbidity is a frequent problem).~     Therefore, this study will aim to recruit 22 older people who are experiencing symptoms of~     depression and anxiety from community mental health teams within the South London and~     Maudsley National Health Service Trust. Participants will be randomly allocated to receive~     either tCBT plus treatment-as-usual (TAU) or 7-week delayed tCBT plus TAU. tCBT will be~     delivered on an individual basis in 12 sessions, each lasting 1 hour, over 14 weeks. It will~     be delivered in outpatient clinics or within the participants residence, depending on~     mobility issues. A number of outcome measures will be used to evaluate the feasibility,~     acceptability and efficacy of tCBT, including ratings on mood questionnaires, rates of~     dropout and reasons for dropout. Outcome measures will be collected before the tCBT~     intervention starts (week 0/baseline), midway through the intervention (after the 6th tCBT~     session/week 7), at the end of the intervention (after the final tCBT session/week 14) and at~     7-week follow-up (week 21) .~      The main hypotheses are:~      i. It will be feasible to adapt and establish a tCBT intervention for older people with~     comorbid depressive and anxiety disorders.~      ii. The tCBT intervention will be acceptable to older people with comorbid depressive and~     anxiety disorders.~      iii. The tCBT intervention will significantly reduce depression and anxiety symptoms relative~     to a delayed-treatment control condition.~   "
139258|NCT01744535|"~     The aim of this study is to implement an exploratory pilot trial of My Meal Mate (MMM), a~     smartphone application developed to facilitate weight loss, assessing its feasibility and~     acceptability. Overweight and obese adults will be recruited from large employers within the~     local area. The trial will aim to recruit a sample size of 135 which is a pragmatic decision~     based on randomizing 45 people to each arm. Participants will be randomized to one of three~     groups. The researchers have developed a smartphone application for weight loss called My~     Meal Mate (MMM) which incorporates a large branded food and drink database. MMM was~     developed using focus group data collected from potential system users and by benchmarking~     with similar commercially available diet tracking applications. One group will receive a~     smartphone with the MMM app downloaded on it, one group will receive access to an online food~     diary and one group will be given a paper food diary. Participants will be asked to set a~     goal for weight loss and self-monitor their food intake and activity using their allocated~     study equipment. Participants will be weighed at the beginning of the trial, at 6 weeks and~     at 6 months. Feasibility and acceptability outcomes will be assessed.~   "
139259|NCT01744522|"~     The purpose of this study is to investigate, whether leech therapy for the treatment of~     postherpetic pain improves pain and sensory function.~      Therefore 20 patients with PHN undergoing leech therapy at the investigators outpatient~     clinic will be included in this observational trial.~   "
139260|NCT01744509|"~     In this study the investigators evaluate the sensitivity of PCC2 (PillCam Colon Capsule 2~     (R)) in identifying significant polyps in a CRC (Colo Recatal Cancer) screening program~     (primary outcome measure).~      Each enrolled patient underwent three procedures: colon capsule endoscopy, CT-colonography~     and optical colonoscopy. In this study the reference standard is represented by the segmental~     unblinded colonoscopy (the unblinding is based on results of both capsule endoscopy and Ct~     colonography) The investigators also evaluated the tolerability of PCC2 as compared to~     optical colonoscopy (OC) and CT-colonography (CTC).~   "
139261|NCT01744496|"~     This trial is being conducted to compare the impact of Rotigotine and Placebo on Chronic Pain~     associated with Parkinson's Disease among patients with advanced stages of the disease.~   "
139262|NCT01744483|"~     Researchers are looking at three different types of breathing tubes to see if any of them are~     better at preventing pneumonia than the others. Two of the tubes have design features to~     prevent leakage of fluids from the mouth and throat into the lungs. This is importance, since~     leakage of small amounts of fluid into the lungs may lead to pneumonia. The third tube is the~     standard tube used at most hospitals.~      The hypothesis is that the use of a breathing tube that reduces fluid leakage into the lungs~     will reduce the risk of developing pneumonia, compared to the standard tube. The study will~     also look at the safety of the modified breathing tubes, compared to the standard tube.~      This study is a small, pilot study that will determine if it is possible to perform a~     larger study that will provide more certain results.~   "
139263|NCT01744470|"~     This prospective, interventional, open label, randomized, multicenter study was designed to~     determine the risk/benefit ratio of a 50 % reduction of Advagraf® daily dose, 4 months after~     transplantation. Randomized patients are to be stable with their tacrolimus daily dose~     required to reach targeted tacrolimus trough levels. Based on Month-3 eligibility~     assessments, patients will be randomized in two groups (1:1): patients with 50 % reduction of~     the daily dose of Advagraf® 4 months after transplantation, and patients kept on their usual~     dose. The benefit/risk ratio will include the assessment of renal function, histological~     lesions from both alloreactivity and CNI nephrotoxicity, and safety data (metabolic and~     infectious diseases).~   "
139264|NCT01744457|"~     Dry Eye Syndrome (DES) is a common condition that affects approximately 20% of adults aged 45~     and older. Although several clinical tests for the diagnosis and monitoring of DES are~     available, currently no gold standard for the assessment of DES exists. It has, however, been~     hypothesized that the assessment of tear film osmolarity may be a new and promising approach~     of an objective and non-invasive method for diagnosis and monitoring of treatment success.~      Recently, a new commercially available instrument (TearLab®, OcuSens Inc, San Diego, USA) for~     the assessment of tear film osmolarity has been introduced. This instrument allows for the~     easy and non-invasive determination of tear film osmolarity. Unfortunately, no data about~     reproducibility are yet available. Consequently, the current study sets out to investigate~     the short time reproducibility of tear film osmolarity measurements using the TearLab®~     instrument.~   "
139267|NCT01744418|"~     The purpose of this study is to assess the safety and efficacy of a novel, tissue-engineered~     vascular prosthesis, the Human Acellular Vascular Graft, HAVG.~      The HAVG is intended as an alternative to synthetic materials and to autologous grafts in the~     creation of vascular access for dialysis.~   "
139324|NCT01743677|"~     ICH E14 recommends that a thorough QT/QTc (TQT) study should be performed to determine~     whether intensive monitoring of QT interval in target patient populations is required during~     later stages of development. The current study is designed to ascertain whether CP-690,550 is~     associated with QTc prolongation.~   "
139268|NCT01744405|"~     The investigators propose to study the transfer of nifurtimox into breastmilk of lactating~     women who receive the drug for the treatment of Chagas disease.~      Breastmilk and blood samples will be obtained from these patients at pre-specified times~     after they take the clinically indicated medication, and the concentrations in both matrices~     will be compared to estimate degree of transfer. Estimation of nifurtimox transfer into~     breastmilk will allow the evaluation of potential degree of exposure of infants breastfed by~     these women to nifurtimox. This study will help clarify safety of continuing breastfeeding~     while receiving treatment with nifurtimox for Chagas disease.~   "
139269|NCT01744392|"~     The investigators propose a 6 month pre-post, pilot,feasibility study with up to 25~     individuals among veterans with cardiovascular disease risk factors including Hypertension~     (HT), Diabetes Mellitis (DM) and Hyperlipidemia (HL) who receive care from the hospital-based~     primary care clinics associated with Durham VAMC. The investigators will examine veteran's~     perception and ease of using an innovative tool to help improve medication adherence to~     cardiovascular medications. This study aims to focus on patients with multiple chronic~     conditions and their caregivers to address 1) appropriate use of medications 2)maximize~     patient self-care and care by families and other caregivers 3) make available a tool for~     medication management 4) managing complex regimens, and 5) addressing health literacy.~   "
139270|NCT01744379|"~     This study will explore the safety, tolerability, and serum uric acid lowering effect of~     lesinurad in healthy Japanese males to allow comparison with the Western population.~   "
139271|NCT01744366|"~     One month degarelix/comparator treatment for prostate cancer in Chinese population~   "
139272|NCT01744353|"~     The purpose of this study is to test the safety, activity and best doses of FOLFOX-A which~     consists of the standard chemotherapy drugs fluorouracil, leucovorin, oxaliplatin and~     abraxane. Each of these drugs are currently used in pancreatic cancer.~      The experimental part of the study is combining these drugs together in FOLFOX-A.~   "
139273|NCT01744340|"~     The purpose of this study is to determine if the full dose of eribulin mesylate can be safely~     given with the full dose of cetuximab. The activity of the combination of eribulin mesylate~     and cetuximab on recurrent head and neck cancer and colon cancer will also be assessed.~   "
139274|NCT01744327|"~     TL1A is a newly discovered signal molecule that may be crucially involved in the maintenance~     of chronic inflammatory disorders. TL1A has also been demonstrated in psoriatic skin but the~     importance of TL1A in psoriasis is still unknown. Understanding inflammatory signal molecules~     in psoriasis is important because the development of new drugs directed against relevant~     signal molecules (e.g. TNF-α and IL12/23) has proved to be a very efficacious treatment~     principle. However, despite the dramatic progress in therapeutic options during the last~     decade, there is still a fraction of patients that are insufficiently treated with the~     currently available therapies. TL1A has been claimed to be the next important target for~     development of biologics in the field of chronic inflammation.~   "
139275|NCT01744314|"~     Patients who present to our institution with a traumatic injury to their elbow who need~     operative management will be randomized to one of two groups; a treatment arm and a control~     arm. The treatment arm will receive a three-week postoperative course of indomethacin while~     the control group will not. We will follow both groups to assess whether or not indomethacin~     prophylaxis affects the rate of heterotopic ossification.~   "
139276|NCT01744301|"~     The purpose of this study is~        1. to estimate the incidence of seizure in the general population and stratified by~          epilepsy status~        2. To estimate the relative risk of seizure associated with use of proton pump inhibitors~          and histamine 2 receptor antagonist and stratified by epilepsy status~   "
139277|NCT01744288|"~     Study to see if platelet transfusion stop or lessen the effect of the drug on platelets~   "
139278|NCT01744275|"~     This a multi-center study to examine whether supplementation with omega 3 fatty acids will~     reduce seizure frequency in patients with epilepsy .~   "
139279|NCT01744262|"~     Robot-assisted laparoscopic radical prostatectomy (RALRP) has gained popularity during the~     past decade and has widely replaced conventional open prostatectomy in many institutions due~     to reduced blood loss, nerve sparing, less postoperative pain and shorter hospital stay.~     However, laparoscopic surgery is performed with intraperitoneal carbon dioxide insufflation,~     which leads to increased intraocular pressure (IOP). In particular, robot-assisted~     laparoscopic radical prostatectomy (RALRP) usually requires a steep Trendelenburg position~     and often prolonged insufflation times, which is known to effect the increase in IOP during~     surgery and may result in ophthalmic complications such as postoperative vision loss (POVL).~     The majority of patients undergoing RALRP is old aged and often present with comorbidities.~     Advanced age, underlying diabetes mellitus (DM) or hypertension renders the patient~     vulnerable to damage due to increased IOP. Moreover, the possibility of the patient having~     undiagnosed glaucoma is also increased, and therefore methods to prevent such complications~     are needed. As of now, intravenous hypnotic agents, inhalation anesthetics and opioids have~     been reported to decrease IOP by relaxing extraocular muscle tone and increasing aqueous~     humour outflow to some extent. Among these agents, propofol has been reported to be more~     effective than other inhalational anesthetics in decreasing IOP. The goal of this~     prospective, randomized controlled trial is to compare the effect of propofol and sevoflurane~     on IOP in patients undergoing RALRP in the steep Trendelenburg position with carbon dioxide~     pneumoperitoneum.~   "
139280|NCT01744249|"~     Assess whether therapy with axitinib, a potent angiogenic inhibitor of the tyrosine kinase~     receptors of VEGF bioavailable by oral administration, is capable of improving PFS in~     patients with advanced G1-G2 NETs of nonpancreatic origin with progressive disease documented~     in the 12 months prior to entering the study.~   "
139281|NCT01744236|"~     The aim of this study is to detail the (mechanisms underlying the) actions of the GLP-1~     receptor agonists and DPP-4 inhibitors on the cardiovascular, renal and gastrointestinal~     systems in patients with Type 2 Diabetes Mellitus.~   "
139310|NCT01743859|"~     The primary objective of this study is to determine the complete remission/complete remission~     with incomplete recovery of blood counts (CR/CRi) rate for relapsed and refractory acute~     myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS) patients.~   "
139311|NCT01743846|"~     Agreement of CNAP pressure with invasive pressure is evaluated dependent on hemodynamic~     variables achieved by a PICCO monitor.~      Hypothesis: Low cardiac output and volume status but not high vascular resistance affect the~     accuracy of CNAP.~   "
139282|NCT01744223|"~     This study will evaluate patients with blood cell cancers who are going to have an allogeneic~     (donor) blood stem cell transplant from a partially matched relative. The research study will~     test whether immune cells, called T cells, which come from the donor relative and are~     specially grown in the laboratory and then given back to the patient along with the stem cell~     transplant (T cell addback), can help the immune system recover faster after the transplant.~     As a safety measure, these T cells have been programmed with a self-destruct switch so~     that if, after they have been given to the patient, the T cells start to react against the~     tissues (called graft versus host disease, GVHD), the T cells can be destroyed.~   "
139283|NCT01744210|"~     Historically, transthoracic Doppler echocardiography has been unable to provide interpretable~     data of blood flow within the lung parenchyma because of air attenuation of Doppler signals.~     Recently, a transthoracic Doppler system known as the Sonara/tek Transcranial Doppler (TCD)~     System has been developed that can identify parenchymal pulmonary blood flow (PPBF) signals.~     The ability to non-invasively collect information regarding the pulmonary aspect of the~     cardio-pulmonary system may provide valuable information and new insights into the structural~     and functional characteristics of the lung parenchyma and vasculature in health and disease~     states.~   "
139284|NCT01744197|"~     Synera, which is a heated topical patch containing both lidocaine and tetracaine, is intended~     to reduce the pain associated with venipuncture and superficial dermatologic procedures by~     numbing the skin. This study will test the effectiveness of the Synera lidocaine/tetracaine~     patch when administered for 30 ± 5 minutes to provide dermal anesthesia in adult oncology~     patients undergoing venipuncture as part of their care, for treatment or diagnostics~     (laboratory or imaging). Compared to the use of the placebo patch, this study hypothesizes~     that the difference of 1 cm on the 0-10 visual analogue scale (VAS) will be observed 30~     minutes after the use of the Synera patch. Pain intensity will be assessed by a 0-10 VAS~   "
139285|NCT01744184|"~     This study aims to determine whether Entonox (gas and air) is at least as good as intravenous~     midazolam in providing analgesia and sedation during gastroscopy. Entonox is used as an~     adjunct in lower gastrointestinal procedures but is not routinely used in gastroscopy, and~     there is only one similar published study to date, which was performed in children. The main~     advantage of Entonox over midazolam is the quick recovery time following withdrawal of the~     agent, which enables patients to return to independent normal life. The investigators would~     like to be able to offer Entonox to patients as an option for sedation during gastroscopy,~     this study is being conducted to determine if it is a safe and feasible option.~   "
139286|NCT01744171|"~     This phase I trial studies the side effects and best dose of vaccine therapy in treating~     patients with stage III-IV melanoma that has spread to other places in the body and usually~     cannot be cured or controlled with treatment (advanced). Vaccines made from peptides or~     antigens may help the body build an effective immune response to kill tumor cells.~   "
139287|NCT01744158|"~     Abnormal limb and trunk movements are seen in many children with cerebral palsy. Recognizing~     the difference between types of these movements is not well understood. This study aims to~     describe how common are these movements in children recruited from a population-based sample~     of children identified on a cerebral palsy register, and to explore associations with motor~     abilities. It is hoped this will lead to improved understanding and recognition of movement~     disorders in CP, to allow clinicians to choose appropriate treatments. We hypothesise that~     the underlying prevalence of dyskinesia is higher than that previously identified through~     conventional motor descriptions in cerebral palsy populations in Australia, and may approach~     20%.~   "
139288|NCT01744145|"~     The mortality rate and quality of life is effected in patients with pneumonia, especially in~     the older population.~      The end point of this study is to improve quality of life by and interventional exercise and~     education. Patients will be randomized at admission and enrolled into the study. They will be~     assessed with various performance and quality of life indicators before, during and after the~     study, and exercise tolerance will be assessed throughout and after.~   "
139289|NCT01744132|"~     The goal of this project is to implement a Collaborative Translational Research Center (TRC)~     Network Study which aims to assure optimal two-way communication between ophthalmologists and~     their patients' primary care physicians (PCP). The Collaborative TRC Network Study will have~     2 objectives:~        -  To design and develop common research protocols to develop a 4-year retrospective~          database (2007-2010) that compiles electronic billing and medical chart information that~          can be used to study individual-level, clinical-level and system-level factors that~          impact access to and quality of vision care;~        -  To evaluate adherence to dilated fundus exams (DFEs) follow-up as the primary~          measureable quality indicator, and its relationship to the patients' demographics,~          ethnicity, socioeconomic status (SES), severity of diabetic retinopathy (DR), other~          ocular and medical co-morbidities, presence of HA1C, and primary care provider (PCP)~          communication.~      By enhancing communication and strengthening the clinical information exchanged between PCPs~     and eye care professionals, this Collaborative TRC Network study will help to overcome~     barriers to obtaining ongoing DFEs and reduce disparities in vision care utilization.~   "
139290|NCT01744119|"~     The purpose of this observational Post-Market Surveillance Registry is to gather post-market~     data on the performance of the CE marked Vascutek Anaconda™ Stent Graft System for the repair~     of Abdominal Aortic Aneurysms (AAA). The Study population consists of patients suitable for~     endovascular repair of AAA. Patients will be followed at 1, 3, 6, 12, 18, 24, 36, 48 and 60~     months post-implantation.~   "
139291|NCT01744106|"~     This study is designed to confirm the effectiveness of single-ingredient pseudoephedrine in~     children for the temporary relief of nasal congestion due to the common cold, an indication~     described under 21 CFR 341.80(b)(1).~   "
139312|NCT01743833|"~     Shoulder impingement has been identified as the most common cause of shoulder pain in the~     adult general population. Sometimes therapeutic pushing on the middle part of the back~     (manual therapy) decreases shoulder pain in someone experiencing shoulder impingement. We do~     not known what causes the decreased shoulder pain. It could be that the therapeutic pushing~     makes things move better. It may be that the person getting their back treatment thinks they~     are better or the physical therapist who provides the manual treatment thinks it works.~   "
139292|NCT01744093|"~     In the context of improved survival from HIV infection itself, chronic obstructive pulmonary~     disease (COPD); a form of lung disease that includes emphysema, which makes breathing~     difficult) is emerging as an important cause of morbidity and perhaps ultimately mortality in~     this population. HIV-infected patients are at increased risk of chronic obstructive pulmonary~     disease, likely due to multiple factors, including an increased presence of smoking, chronic~     inflammation and progression of immunodeficiency, oxidant stress (excessive levels of natural~     chemicals called oxidants and free radicals that can damage tissue), and respiratory~     infections. While natural history data on COPD are limited in the era of potent~     antiretroviral therapy, earlier data suggest that the course of emphysema may be accelerated~     in this population. Our preliminary data suggest that several matrix metalloproteinases~     (MMPs) derived from alveolar macrophages (a type of immune cell found in the lungs) have an~     increased cellular response in HIV-infected smokers, which could contribute to accelerated~     emphysema. Matrix metalloproteinases are enzymes that break down the structural support of~     tissues, including the airways in the lung.~      Based on these observations, the investigators hypothesize that pharmacologic inhibition of~     matrix metalloproteinases by doxycycline will favorably modify the natural history of chronic~     obstructive pulmonary disease in HIV-infected patients. To test this hypothesis, the~     investigators propose conducting a proof of concept pilot study as a prelude to a possible~     phase II randomized, placebo-controlled trial (testing safety and efficacy in a larger~     population controlled with a sugar pill) of doxycycline for COPD in HIV-infected patients~     should the proof of concept be successful. Our research team is lead by a~     pulmonologist/researcher with expertise in HIV-associated COPD and an infectious diseases~     specialist/clinical trials expert.~   "
139293|NCT01744080|"~     The purpose of this prospective randomized controlled trial is to compare post-operative~     outcome between participants undergoing expedited surgery compared to those proceeding~     through a 'typical' wait time process. A secondary purpose is to evaluate the progression of~     rotator cuff tear size from the time of initial consult to the time of surgery.~   "
139294|NCT01744067|"~     Omega-3 fatty acids are provided through dietary intake of fish and seafood. Several dietary~     supplements containing omega-3 fatty acids are also commercially available. Some studies have~     described beneficial effects from omega-3 fatty acids, among them are anti-inflammatory,~     anti-thrombotic, anti-atherosclerotic, anti-arrhythmic, anti-hypertensive and~     lipid-modulating effects. Other studies have not confirmed these findings. This study will~     investigate the effects of omega-3 fatty acids on renal function and cardiovascular risk~     markers in renal transplant recipients.~   "
139295|NCT01744054|"~     The successful localization of the y90 microspheres by PET/MR and/or PET/CT scans would be a~     useful tool in individualizing patient care after the radioembolization procedure. The~     information from a PET/MR or PET/CT scan would allow for early evaluation of the technical~     success of the procedure.~   "
139296|NCT01744041|"~     Perinatal depression is a major public health problem, affecting 15% of women during~     pregnancy through the postpartum period, with adverse consequences for the mother, the fetus,~     the infant, and the family. Despite increasing evidence of the importance of this critical~     risk interval, little research has investigated the effects of depression treatment during~     pregnancy on infant outcomes. The purpose of this study is to test the feasibility,~     acceptability, and effectiveness of a new intervention, Interpersonal psychotherapy for the~     mother-infant dyad (IPT-Dyad). This intervention begins during pregnancy and continues with~     the mother and infant until one year postpartum. The investigators hypothesize that IPT-Dyad~     will be better than treatment as usual in reducing depressive symptoms, improving~     psychosocial functioning,increasing parenting self-efficacy, improving infant emotional~     development, and enhancing mother-infant relationship quality.~   "
139297|NCT01744028|"~     The purpose of this pilot study is to evaluate a remote patient monitoring (RPM) system using~     a daily PRO tool (EXACT = Exacerbations of Chronic Pulmonary Disease Tool), in preventing~     hospitalization from Chronic Obstructive Pulmonary Disease (COPD) exacerbations in a COPD~     population at high risk of exacerbation, compared to those managed by usual care.~   "
139298|NCT01744015|"~     1. (Primary) To compare the effectiveness of a patient guided choice of care using a~          patient decision support tool to clinical guided care within a novel care process for~          non-specific low back pain.~           (We hypothesize that the patient guided choice model will demonstrate significant~          improvements when compared to the clinician guided care approach)~        2. (Secondary) To qualitatively investigate which components of the patient choice~          educational methods were most effective for informed decision making among patients who~          participate in the patient guided choice of care approach (We hypothesize that dialogue~          method of patient guided choice will be identified as most useful)~   "
139299|NCT01744002|"~     The objective of this study is to investigate whether treatment directed at the neck and~     shoulder is more beneficial than treatment directed solely at the shoulder; for patients with~     shoulder impingement syndrome.~      (The hypothesis is that patients who receive neck mobilization will improve at a more~     significant rate than those who do not receive neck mobilization)~   "
139300|NCT01743989|"~     This study aims to assess the optimal duration of nilotinib 300 mg BID consolidation~     treatment, in order that patients remain in treatment-free remission (≥MR4.0) 12 months after~     starting the Treatment-Free Remission (TFR) phase of the study.~      Rationale:~      CP-CML patients who have received 2 or more calendar years of first-line imatinib treatment,~     and who have failed to achieve the molecular response threshold for treatment cessation~     (≥MR4.0) have a 50% greater chance of doing by switching to nilotinib; however the optimal~     duration of consolidation treatment with nilotinib to ensure the highest rate of patients~     remaining in ≥MR4.0 after entering the TFR phase is not yet known. This protocol therefore~     aims to assess the potential impact of a longer duration of consolidation treatment with~     nilotinib, i.e. 12 months versus 24 months, on molecular relapse rate in the first 12 months~     of treatment-free remission.~   "
139301|NCT01743976|"~     Based on laboratory studies, donepezil will improve pain relief more than placebo in patients~     with chronic neuropathic pain who are currently taking gabapentin or pregabalin.~   "
139313|NCT01743820|"~     The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of low~     single-dose primaquine for gametocidal activity against P.falciparum among adult~     glucose-6-phosphate dehydrogenase (G6PD)-normal malaria patients.~   "
139371|NCT01743066|"~     To understand the pathogenesis of chronic arsenic toxicity, the investigators need to know~     the levels of vitamin E in patients chronically exposed to high concentration of arsenic and~     if changes are found, what happens when supplemented with vitamin E. The buccal cells and~     serum of patients will be collected for the estimation of vitamin E both before and after~     supplementation with vitamin E. Similar samples will be collected from similar number of~     arsenic exposed controls and healthy volunteers for comparison.~   "
139302|NCT01743963|"~     Using glucocorticoid induced diabetes (GID) we will conduct a small feasibility randomized~     intervention trial to improve GID management for veterans who are prescribed chronic~     glucocorticoids. Approximately 20 primary care providers (caring for approximately 100~     veterans on chronic steroids) will receive decisional support (automatically-derived orders~     for hemoglobin A1C, to be co-signed by providers). Approximately 20 providers (caring for 100~     veterans) who did not receive decisional support will serve as the control population. We~     will measure the time from randomization until the provider signs an order for hemoglobin A1C~     for both groups. The trial will be conducted at the VA's Eastern Colorado Health Care System~     (ECHCS) and will last approximately 6 months. After the completion of the trial for each~     provider, we will conduct a brief interview and survey of the participating providers to~     assess the acceptability of decisional support interventions to manage GID [protocol, page~     1-2]. No patient data (PHI) will be collected by the providers.~   "
139303|NCT01743950|"~     To determine the efficacy of Pulse Reduced Dose Rate (PRDR) radiation when given in 27~     fraction over 5.5 weeks with concurrent bevacizumab followed by adjuvant bevacizumab until~     time of progression in patients with recurrent high grade gliomas (grade III and grade IV).~     Patients will be placed in 1 of 4 groups based on their histologic diagnosis and prior~     exposure to bevacizumab.~   "
139304|NCT01743937|"~     Antiplatelet therapy remains a cornerstone in the treatment of acute and chronic coronary~     artery disease. Aspirin was the first such therapy to prove its benefits in acute myocardial~     infarction. Compared to aspirin monotherapy, the combination of aspirin and clopidogrel, a~     thienopyridine P2Y12 inhibitor, has been demonstrated to reduce adverse event rates among~     patients with acute coronary syndromes (with or without ST-segment elevation) and those~     receiving intracoronary stents. In the Triton-TIMI 38 trial a novel thienopyridine,~     prasugrel, was compared to clopidogrel in patients with acute coronary syndrome undergoing~     percutaneous coronary intervention. Although prasugrel significantly reduced recurrent~     myocardial infarction, bleeding rates were increased and no improvement in cardiac or~     all-cause mortality was demonstrated. However, in 2009, the authors of the PLATO trial~     demonstrated an unexpected cardiovascular mortality benefit with ticagrelor over clopidogrel,~     an endpoint not previously met by any other antiplatelet agent against an active comparator.~     Based on the reproducible adverse events seen in the DISPERSE, DISPERSE-2, and PLATO trials,~     an adenosine-mediated effect of ticagrelor is proposed.~      Hypothesis: The aim of this study is to test the hypothesis that ticagrelor produces~     pharmacologic ischemic preconditioning, an undescribed potential off-label property of~     ticagrelor that could represent a plausible mechanism for its effects on cardiovascular~     mortality.~   "
139305|NCT01743924|"~     The aim of this study was to determine the absorption of isothiocyanates (ITC) after~     ingestion of kailan-hybrid broccoli through the analysis of the correspondent urinary~     biomarkers. Furthermore, the effect of cooking (microwave) on the mentioned metabolic fate of~     these ITC was studied comparing to the uncooked vegetable.~   "
139306|NCT01743911|"~     Left ventricle diastolic dysfunction (LVDD) is associated with resistant hypertension. In~     addition, brain natriuretic peptide (BNP) levels are elevated when LVDD is present. It has~     been shown that phosphodiesterase-5 (PDE5) inhibition improves left ventricle diastolic~     function in hypertensive rats, despite any difference in blood pressure levels. Also, left~     ventricle diastolic function enhancement reduces BNP concentration in hypertensive patients.~     However, it is unknown if these effects exists in humans with resistant hypertension.~     Therefore, this study was developed to evaluate if the use of a PDE5 inhibitor (tadalafil)~     for 2 weeks improves LVDD and its effects in BNP levels in resistant hypertensive patients.~   "
139307|NCT01743898|"~     The ability to explain bleeding or clotting complications in patients treated with~     rivaroxaban remains challenging. In addition, there is limited data on how coagulation tests~     perform in patients treated with therapeutic doses of rivaroxaban. Predicted responses of~     coagulation tests to therapeutic doses of rivaroxaban may be helpful in better understanding~     abnormal responses to rivaroxaban. The purpose of the study is to define a therapeutic~     reference range for peak and trough coagulation tests in patients taking FDA approved doses~     of rivaroxaban and to determine which tests may be most clinically useful for monitoring~     rivaroxaban.~   "
139308|NCT01743885|"~     There is no effective treatment for hemangioma regardless of immediate severity. That is in~     this respect a orphan disease. These hemangiomas, sometimes large, will have a phase of~     proliferation of several months (very scary for parents) and regression over several years.~     The natural history is peppered with local complications (ulcers) and aesthetic and~     psychological sequelae (sometimes major for the child and the family). The effects of~     acebutolol and propranolol on the proliferative hemangiomas were discovered accidentally by~     two French teams (Montpellier for acebutolol and Bordeaux for propranolol). Acebutolol and~     propranolol have been used for many years for the treatment of hypertension and congenital~     heart disease, including infants, with few side effects. The effects of acebutolol and~     propranolol were immediately visible with reduced volume and skin whitening of the~     hemangioma. In a preliminary study, acebutolol was administered to 20 patients in Montpellier~     with big regression of hemangiomas. The aim of the study was to compare the clinical efficacy~     of acebutolol (10mg/Kg/jour) and propranolol (3mg/Kg/j) on the proliferative phase of~     infantile hemangioma in infants.~   "
139309|NCT01743872|"~     Iodinated contrast is the current gold standard for infrainguinal angiography imaging in~     patients without renal insufficiency and has also been used with intravascular Optical~     Coherence Tomography (iOCT) to improve image quality in human coronary arteries as well as~     carotid arteries. The current debate in the literature for iOCT medium is between iodinated~     contrast and dextran and CO2 may offer a superior method of iOCT imaging during lower~     extremity occlusive disease interventions.~      The investigators hypothesize that the CO2 medium injection during iOCT data acquisition is~     feasible and will produce at least the same quality of imaging as that obtained with contrast~     or dextran without causing the problems of volume overload and renal toxicity seen with the~     two latter mediums.~      Primary Outcomes Measured~        -  Quality: Cumulative number of clear image frame (CIF) through the entire 54mm length~          segment.~        -  Quantitative: Calculations of the area and diameter of each segment will be measured to~          determine if index of refraction has any effect between the three mediums to be tested.~      The investigators expect to find little difference between all three iOCT mediums and hope to~     conclude that CO2 offers a superior side effect profile for iOCT imaging in the lower~     extremity arterial system.~   "
139314|NCT01743807|"~     This is a phase I trial of an investigational drug called GNKG168 in patients with relapsed~     and refractory acute lymphoblastic leukemia (ALL) and acute myelogenous leukemia (AML) who~     are in morphologic remission but are positive for Minimum Residual Disease (MRD). GNKG168 is~     a Toll-like receptor (TLR) agonist. TLR agonists are a novel approach to stimulate an~     effective anti-tumor immune response as they are able to stimulate both innate and adaptive~     immune responses. There will be two strata i.e patients who have received hematopoietic stem~     cell transplant (HSCT) and patients who have never undergone HSCT. GNKG168 will be~     administered as a 60 min iv infusion. One 14-day cycle consists of 5-day treatment followed~     by 9 day-rest. Patients will receive 2 cycles before evaluation. The primary objective is to~     determine the maximum tolerated dose of GNKG168 in relapsed ALL and AML patients.~   "
139315|NCT01743794|"~     Introduction : Spine surgery is responsible for intense postoperative pain that can be~     treated by an analgesia multimodal approach (IV analgesic infusion and local anesthesia).~     Continuous wound infiltration is an efficient and simple technique with few adverse effects~     yet very few studies have investigated its potential use in spine surgery. Our randomised,~     controlled, double-blinded trial aims to evaluate efficacy of continuous wound infiltration~     after major spine surgery.~      Methods : After written consent is obtained, the surgeon inserts, at the end of surgery, a~     multiholes catheter under muscular layers. Patients are randomised in two groups : The~     treated group receives ropivacaine 0.2% infusion (bolus of 10 milliliters (mL) followed by~     8 mL/h continuous infusion during 48 hours) and the control group receives saline solution~     (0.9%). In addition, all patients receive patient-controlled intra-venous morphine analgesia.~     The investigators hypothesize that the treated group will consume morphine less than the~     control group.~   "
139316|NCT01743781|"~     1. To evaluate a educational intervention promoting acceptance of comprehensive eye~          examination in rural Guangdong.~        2. To evaluate the impact of acceptance of comprehensive eye examination in rural~          Guangdong.~   "
139317|NCT01743768|"~     Asthma is a chronic inflammatory bronchial disorder with three distinct components: airway~     hyper-responsiveness (respiratory hypersensitivity), airway inflammation, and intermittent~     airway obstruction. One of the characteristics of the disease is an inflammatory reaction of~     the immune system caused by cytokine production. A substantial number of asthma patients do~     not satisfactorily respond to steroid therapy and consequently have an unmet medical need for~     novel targeted therapies with improved specificity, tolerability, and compliance.~      Novel therapeutic strategies for the treatment of chronic inflammatory diseases by targeting~     early disease-causing mechanisms are a promising approach for the treatment of asthma. The~     transcription factor GATA-3 plays a key role in mediating the asthmatic immune response and~     has been shown to be necessary and sufficient for the production of cytokines interleukin~     (IL)-4, IL-5, and IL-13. The active drug substance of the investigational medicinal product~     SB010 is hgd40. SB010 belongs to a new class of antisense oligonucleotide therapeutics, the~     10-23 DNA (deoxyribonucleic acid)zymes (antisense oligonucleotide).~      DNAzymes are catalytically active nucleic acids that cleave complementary RNA (ribonucleic~     acid) molecules. By cleaving GATA-3 mRNA, hgd40 reduces specific cytokine production and~     thereby reduces key features of allergic airway inflammation. DNAzymes are generated~     completely by chemical synthesis and can be produced under Good Manufacturing Practice (GMP)~     controlled conditions. The DNAzymes are not biological drugs, i.e. they are not generated by~     use of any living organism including cell culture or bacteria. The molecules are highly~     water-soluble and will be applied as solution directly in their synthesized form.~      This proof-of-concept study will evaluate the safety, tolerability, efficacy,~     pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of inhaled SB010 in male~     patients with mild asthma.~   "
139318|NCT01743755|"~     The present study is designed to investigate the beneficial effects of adjunctive~     dexamethasone therapy in patients admitted with community-acquired pneumonia, additionally~     aiming at assessing what patients benefit from dexamethasone treatment mostly. A large~     multicenter study will be conducted comparing a 4 days dexamethasone 6 mg per os course with~     placebo in 600 patients and with predefined subgroup analyses planned.~   "
139319|NCT01743742|"~     To study the role of single high dose vitamin E and vitamin C in hypoxic ischemic~     encephalopathy in newborns, in reduction of morbidity and adverse neurodevelopmental~     sequelae.~   "
139320|NCT01743729|"~     The purpose of the study is to evaluate the safety and efficacy of lifitegrast ophthalmic~     solution compared to placebo in the treatment of dry eye.~   "
139321|NCT01743716|"~     This study aims to examine the relationship between mood and brain activity in adolescent~     girls in order to better understand the genetic and neural predictors of adolescent~     depression. The participants in this study will be healthy female adolescents aged 12-14 and~     their mothers. They will participate for a total of six months. Adolescent participants will~     have three study sessions at McLean Hospital, and during two of them, their mothers will also~     have assessments. Adolescent assessments will include interviews, questionnaires, computer~     tasks, and collection of a saliva sample for genetic analyses. Their second study visit will~     include an fMRI scan. Parent assessments will include an interview, questionnaires, and a~     computer task.~   "
139322|NCT01743703|"~     The diagnosis of abuse in children relies heavily on the presence of skeletal and~     extraskeletal injuries. However, some lesions are not seen by initial skeletal survey. And~     the investigators have to complete the skeletal survey with either bone-scan or CT scan or~     whole-body MRI. whole-body MRI has proved its worth in the pediatric population for the~     evaluation of skeletal and extraskeletal lesions in children with cancer or infectious~     diseases. Thus, whole-body MRI would allowed to have total picture of children without~     ionising radiation exposure.~   "
139323|NCT01743690|"~     The aim is to investigate the effect of probiotic bacteria on symptoms and clinical~     manifestations in patients with oral lichen planus (OLP).~      The hypothesis is that probiotic bacteria can favor an oral environment that reduces the risk~     of symptomatic candidal and bacterial infection in OLP.~      The negative influence of improper oral hygiene on OLP is established and overgrowth of~     Candida is a common problem. Nystatin is the only topical antifungal that does not interact~     with other drugs and to which the majority of the candida species are susceptible.~     Symptomatic treatment with fluocinolone is initiated in patients without candidal infection.~     Probiotic bacteria can affect the microbial homeostasis by reducing the overgrowth of~     pathogens e.g. candida. Different probiotic species have been shown to produce antifungal~     substances and reduce the growth of candida albicans in vitro. The probiotic strain~     Lactobacillus rhamnosus has been found to reduce the salivary count of yeasts among elderly~     in a randomized clinical study.~      The study is planned as a blinded, randomized controlled study with four parallel arms. 120~     OLP patients with symptoms form the mucous membranes are included in the study and will~     receive nystatin or fluocinolone treatment depending on positive or negative diagnosis of~     candidosis. In addition, they will be assigned to either the probiotic (A) or the placebo~     group (B) by randomization. The groups will be encouraged to take three tablets per day~     (morning, noon and evening)for eight weeks. The lozenges containseither two strains of the~     probiotic bacterium L. reuteri (A) or placebo (B). Cytosmears, saliva sample, and saline~     mouth wash will be taken at baseline, after the treatment period and at follow-up visits at~     8, 16, 24 weeks and 1 year. Salivary counts of the probiotic strains, the clinical~     manifestations and symptoms associated to OLP will be recorded.~   "
139325|NCT01743664|"~     Multiple Sclerosis (MS) can be associated to many psychological symptoms. One of the most~     relevant is the experience of distress related to the disease, that can lead to the~     development of Post Traumatic Stress Disorder (PTSD). As far as we know there are no studies~     on the efficacy of psychological treatments in MS in spite of its relevance for patients'~     quality of life. Primary aim is to evaluate the efficacy of the treatment with Eyes Movement~     Desensitization and Reprocessing(EMDR) in PTSD secondary to MS. EMDR is the elective~     treatment (together with Cognitive Behavioural Therapy) for PTSD according to international~     guidelines. The secondary aims are to evaluate the efficacy of EMDR on the PTSD-associated~     symptoms of anxiety and depression and Quality of Life. The study design is a randomized~     clinical trial. Sixty patients with MS and PTSD will be pre-screened by using the IES-R and~     the Clinician Administered PTSD Scale. The patients will be randomized in two groups (30 in~     the experimental group and 30 in the control group).The psychological assessment will be~     performed in both groups with the same timing and tools: at baseline (T0), after treatment~     (T1) and 6 months later (T2) by two trained clinical psychologists (independent and blind to~     treatment) with the CAPS and the administration of self reports: Trauma Antecedent~     Questionnaire, Chicago Multiscale Depression Inventory, Hospital Anxiety and Depression Scale~     and Functional Assessment of Multiple Sclerosis. The experimental group will undergo 10~     weekly sessions of 60 minutes each with EMDR following Shapiro's protocol for traumatic~     events. The efficacy will be evaluated comparing the results between T0, T1 and T2 and~     comparing the scores of the experimental and the control groups. Primary outcome measures~     will be: 1) the proportion of participants at T1 and T2 no longer meeting the Diagnostic and~     Statistical Manual (DSM IV-TR) diagnostic criteria for PTSD; 2) the reduction of CAPS scores~     for the four PTSD dimensions from pre-treatment to post-treatment evaluation and follow-up~     (avoidance, reexperiencing the traumatic event, hyperarousal and numbing). Secondary outcome~     measures will be: comparison of the scores of CMDI, HADS and FAMS of the two groups at T0, T1~     and T2. The statistical procedure applied will be a repeated measures analysis of covariance~     both on the primary outcome continuous measures and on the secondary ones.~   "
139326|NCT01743651|"~     This is a multicenter, randomized (1:1:1), double-blind, active and placebo controlled,~     parallel group study to evaluate safety, tolerability and efficacy of oral arbaclofen in MS~     patients with spasticity.~      Eligible subjects will be removed from anti-spasticity mediations for at least one week and~     then begin study drug treatment with daily doses increasing up to the target dose which will~     then be maintained for at least 12 weeks. A down-titration will then occur over two weeks~     with the final study visit occuring at 19 weeks from start of achieving the target dose or 22~     weeks from the Study Visit 1.~   "
139327|NCT01743638|"~     The purpose of this study is to see if MR-guided laser ablation can effectively treat~     prostate tumor recurrences.~   "
139328|NCT01743625|"~     The purpose of this study is to show the effectiveness of COV155 compared to placebo in~     subjects with acute moderate to severe pain following bunionectomy surgery.~   "
139329|NCT01743612|"~     The aim of the study is to determine if postocclusive hyperemia of palmar and dorsal face of~     the hand with Laser speckle contrast imaging discriminate between patients with systemic~     sclerosis, subjects with primary Raynaud's phenomenon and healthy subjects.~   "
139330|NCT01743599|"~     Diabetic men and controls are examined for retrograde ejaculation, and erectile dysfunction~     is registered with a validated questionaire (International Index of Erectile Function-15).~     Concentration, total number of sperm and motility is determined in freshly delivered~     ejaculates and postejaculatory urine. Our hypothetis is that diabetics exhibit significantly~     higher rate of retrograde ejaculation than healthy controls.~   "
139331|NCT01743586|"~     The purpose for the 1st phase of this study are to exam longitudinal changes and the impact~     of various treatments on the respiratory muscle function, and the relations with dyspnea,~     functional capacity, quality of life, 6- and 12-month respiratory morbidity, and survival~     status (control group). The 2nd phase of this study will investigate the potential beneficial~     effects of chest physiotherapy in the same patient population (intervention group).~   "
139332|NCT01743573|"~     This study wants to prove that Yoga Training can improve physical Fitness, immunity, and~     quality of Life of in Breast Cancer Survivors. In summary, our findings show potential~     benefits of yoga for people with cancer in improvements of psychological health. Because of~     the small number of studies having been conducted and the methodological limitations, the~     results should be regarded as preliminary and treated with caution. Our preliminary findings~     also provide practitioners with important information that yoga may be a possible adjunctive~     therapy for cancer patients to help manage psychological distress and to improve quality of~     life.~   "
139333|NCT01743560|"~     Determine the overall response rate (ORR) at 48 weeks to everolimus (RAD001, 10mg daily p.o.)~     and exemestane (25mg daily p.o.) treatment in postmenopausal women with oestrogen receptor~     positive breast cancer who have previous experienced recurrence or progression on~     non-steroidal aromatase inhibitor (NSAI) therapy.~   "
139334|NCT01743547|"~     This is a pilot study to establish the feasibility of an eight-week yoga intervention and to~     estimate the effect size on QoL in female patients with ovarian, fallopian tube and primary~     peritoneal malignancies receiving chemotherapy for the treatment of primary or recurrent~     cancer.~   "
139335|NCT01743534|"~     The insanities, priority of public health in 2008, have significant prevalency in Limousin,~     region in the ageing demography (1/3 of the population is more than 60 years old against~     1/5th of average in France). To prevent the lack of therapeutic solutions, for these~     evolutionary diseases, the new plan Alzheimer 2008-2012 encourages the research.~      The insanities deprive gradually the individual of their autonomy, their personality and~     their identity. The help of an institution is sometimes inevitable. In the middle of this~     stressful environment, the patient affected by severe insanity, need marks.~      The aspect of their old objects, significant for them, has to be prioritized because the~     institutional universe, often depersonalized doesn't mean anything for them. In front of~     repeated failures, they're hurt in their self respect.~      The prevention of the undernutrition, comes by a preservation of praxis and pleasure at~     table. The institutional plate used in certain hospital sectors, is unpersonal (rectangular,~     divided) and can be destabilizing for the mentally ill person.~   "
139336|NCT01743521|"~     To examine the safety and efficacy of response guided triple therapy (PEG-IFN, Ribavirin,~     Telaprevir) for the treatment of early chronic Hepatitis C Virus (HCV) infection.~   "
139372|NCT01743053|"~     This is a prospective, randomised, open label, controlled pilot study to evaluate the safety~     and preliminary effectiveness of the ReCell Autologous Cell Harvesting Device (ReCell) for~     the management of chronic leg ulcers associated with venous insufficiency. Outcome will be~     compared between study participants receiving standard care (debridement, compression~     therapy) and participants receiving ReCell in addition to standard care.~   "
139373|NCT01743040|"~     This is a multi-center, prospective, non-randomized, double-blinded trial to evaluate the~     performance of the CADence device in detecting the existence of clinically significant~     coronary artery disease.~   "
139337|NCT01743508|"~     Uganda is one of the countries with highest fertility rate in the world, 6.7 children per~     women. It is estimated that 56 percent of all pregnancies are unintended and the~     contraceptive prevalence rate in Uganda is 23 percent. Unwanted pregnancy is common and~     induced abortion is illegal. Unsafe abortion is responsible for significant morbidity and~     mortality among women in Uganda. Almost 40% of admissions to emergency obstetric care units~     in Uganda due to unsafe abortion is reported and considered high in international comparison.~     Studies have revealed that trained midlevel providers can deliver safe post abortion care for~     incomplete abortion and use manual vacuum aspiration. The prostaglandin E1 analogue~     misoprostol has been shown to be an effective tool in the treatment of incomplete abortions.~     This option is so far under-used in developing countries, especially outside the larger~     hospitals and private clinics. One significant limiting factor in providing safe post~     abortion care is the lack of providers. So far technical training has been mainly limited to~     physicians. Training of midlevel providers in misoprostol treatment of incomplete abortion~     will support task shifting in places where doctors are costly and scarce. By evaluating the~     effectiveness of mid-level providers (midwives); conducting MVA and administering misoprostol~     treatment of incomplete abortion the project is attempting to contribute to the reduction of~     maternal mortality and morbidity and safeguard high quality of post-abortion care.~      Women with incomplete abortion will be randomly allocated to undergo a clinical assessment~     and treatment (MVA or misoprostol) either by physician or midwife with safety and efficacy as~     main outcomes in a RCT carried out in hospital setting in Uganda. Our hypothesis is that~     there are no significant differences in effectiveness and safety between manual vacuum~     aspiration and misoprostol treatment of incomplete abortion provided by physicians and~     midwife.~      The involvement of midlevel providers in treatment of incomplete abortion has previously not~     been systematically evaluated in African health care setting.~   "
139338|NCT01743495|"~     The Johns Hopkins School of Nursing offers this research study which aims to learn more about~     whether services that help with medications, muscle strengthening, pain management and~     changes to houses can help improve older adults' ability to, walk, and take care of~     themselves while saving costs by reducing hospitalizations and nursing home admissions.~   "
139339|NCT01743482|"~     This is an open label, single arm, single center, phase 2 study with the use of the~     antiangiogenic multikinase inhibitor pazopanib in a population of patients with germ cell~     tumors who are not cured following first or subsequent chemotherapy lines for metastatic~     disease, followed by eventual surgery.~   "
139340|NCT01743469|"~     This was an exploratory proof of concept study to determine the clinical activity of~     tasquinimod in patients with advanced or metastatic hepatocellular carcinoma, ovarian~     carcinoma, renal cell carcinoma and gastric carcinoma who had progressed after standard~     therapies.~   "
139341|NCT01743456|"~     Post-Operative Cognitive Decline (POCD) is common after cardiac surgery and associated with~     increased morbidity and mortality. The pathophysiology of POCD is only poorly understood.~     Causes include hypoperfusion, microemboli and the systemic inflammatory response, which~     result in a reduction of cerebral oxygen delivery.~      Cerebral oxygenation can be monitored non-invasively by measuring frontal lobe oxygen~     saturation (rSO2).~      The bispectral index (BIS) of the electroencephalogram is widely known to measure depth of~     anaesthesia, and there is a high correlation between BIS, a dimensionless calculated number~     between 0 and 100, and clinical criteria of sedation. With BIS below 60 recall is extremely~     low.~      The investigators demonstrated recently that inappropriately high levels of anaesthesia may~     be associated with poorer long-term outcomes in cognition after non-cardiac surgery (Ballard~     et al. 2012). Whether optimisation of the depth of anaesthesia and cerebral oxygenation has~     an effect on postoperative cognitive function in patients undergoing cardiac surgery is~     unknown.~      The investigators hypothesize that the incidence of POCD in elderly patients (> 65 years old)~     at 6 weeks is less with mildly deep anaesthesia (BIS 50 +- 10) and optimised rSO2~     (interventions when rSO2 drops below 15% of baseline reading) when compared with current~     practice (BIS blinded anaesthesia, reflecting moderately to highly deep anaesthesia and~     blinded rSO2 measurements).~   "
139342|NCT01743443|"~     To evaluate corneal sensitivity changes following corneal cross-linking (CXL) in patients~     with progressive lower stage keratoconus.~   "
139343|NCT01743430|"~     Study 1: Background and Purpose—This study were to set up the telerehabilitation program for~     standing balance training, and to examine the training effects on balance and daily~     activities in subjects with subacute stroke.The null hypothesis included telerehabilitation~     balance training were not significantly different from conventional balance training in~     subjects with subacute stroke.~      Study 2: The purpose of this study was to investigate the effects of telerehabilitation with~     group therapy on balance and daily activities in subjects with stroke living in long-term~     care facilities (LTC).The null hypothesis would be telerehabilitation balance training were~     not significantly different from conventional balance training in subjects with subacute~     stroke.~      study 3:To investigate whether a four-week tele-rehabilitation program can result in~     significant improvements in physical function and quality of life for subjects with chronic~     stroke living in long-term care facilities.~      Study 4: To compare the effects of a home-based telerehabilitation (Tele) with intelligent~     agent systems and a conventional in-home physical therapy (home PT) for subjects with stroke.~   "
139344|NCT01743417|"~     Brain training exercises will be provided to children who survived an episode of severe~     malaria. These children will be given assessments for cognition, behaviour and executive~     functions before and after the brain training exercises.~   "
139345|NCT01743404|"~     The purpose of this study is to investigate the anti-atherosclerotic effect of long-term~     anti-inflammatory therapy (Inflaminat) in asymptomatic participants with subclinical~     atherosclerosis of carotid arteries.~   "
139346|NCT01743391|"~     By randomizing sub-fertile women to either control or office-hysteroscopy in the circle prior~     to IVF or ICSI (intracytoplasmatic sperm injection~      ) treatment, we aim to enlighten whether hysteroscopy with endometrial biopsy increases~     pregnancy rates in the intervention group.~   "
139347|NCT01743378|"~     A Prospective double-blinded randomized clinical trial to test the effect of transversus~     abdominis plane block on postoperative pain and opoid consumption after abdominal~     hysterectomy.~      Two groups of each 24 patients. All patients are given general anesthesia. The patients are~     randomized to have a ultrasound guided bilateral transversus abdominis plane block with~     either 2 x 20 ml 0,75 % ropivacaine or 2 x 20 ml of 0,9 saline. All patients are provided~     with a PCA for self administration of morphine.~      Pain score on visual analog scale, nausea and vomiting are monitored at 1, 2, 4, 6, 8 and 24~     hours postoperatively as well as the total consumption of morphine after 24 hours.~   "
139374|NCT01743027|"~     The purpose of this study is to evaluate an ophthalmic solution for the treatment of ocular~     itching associated with allergic conjunctivitis using the Conjunctival Allergen Challenge~     (CAC) model.~   "
139790|NCT01737606|"~     The new technical of ultrasonic exploration of this project purpose to validate the~     measurement of cerebral pulsatility by a new way called Fast Cerebral Pulsatility Imaging~     (FCPI).This will somehow determine the natural history of cerebral pulsatility during~     development adult to old age~   "
139348|NCT01743365|"~     The purpose of this study is to evaluate the efficacy and safety of the combination of~     Cisplatin,5-Fluorouracil(5FU) and Afatinib as first-line therapy in patients with advanced~     gastric or gastroesophageal junction cancer. The study will include 55 patients in all. The~     patients will receive open-label Cisplatin intravenous 75mg/m2 on Day 1, 5FU 750mg/m2 at~     24-hour intravenous infusion on Days 1-4, and Afatinib 40mg per os on Days 3-5, 8-12, 15-19.~      The administration of Afatinib will start on Day 3 of each therapy cycle with an~     administration interval on each weekend (Weekday on, Weekend off) for 21 days. Instructions~     are given on the dose reduction scheme in the presence of toxicity. The administration of the~     combination Cisplatin-5FU-Afatinib will be continued until disease progression, appearance of~     significant toxicity, completion of 6 treatment cycles, or withdrawal of consent. At~     completion of 6 cycles of the combination, in the absence of disease progression, the~     administration of Afatinib as maintenance monotherapy will be continued until disease~     progression, appearance of significant toxicity, or withdrawal of consent at the weekday~     on-weekend off schedule. Imaging will be applied once every 8 weeks, and once every 12 weeks~     in the Afatinib maintenance therapy phase.~   "
139349|NCT01743352|"~     The aim is to compare a new technique for assessing mechanical properties of large arteries:~     the Ultrafast echo with the reference technique, the echotracking. This will be done by~     studying in parallel hypertensive patients and controls with both techniques and this will~     revisit old concepts of increased stiffness in hypertensive arteries.~   "
139350|NCT01743339|"~     The primary purpose of this study is to test whether and how cognitive-behavioral therapy for~     insomnia (CBTi), a well-supported and highly effective insomnia treatment, may directly~     improve Posttraumatic Stress Disorder (PTSD) and Major Depressive Disorder (MDD) symptoms.~     The study is designed as a randomized controlled trial (RCT) to test the effect of CBTi on~     symptoms of PTSD and co-morbid depression prior to an evidence-based PTSD intervention and to~     assess the role of neurobiological processes and sleep architecture in mediating treatment~     outcomes.~   "
139351|NCT01743326|"~     Rationale: the facet joints are an important pain generator in chronic neck pain. The~     beneficial effect of radio frequency treatment (RFD) of the cervical facet joints has been~     described in a Randomized Clinical Trial (RCT) in patients with Whiplash Associated~     Disorders. In patients with degenerative neck complaints a positive effect has been described~     in observational studies. Given this positive effect performing a RCT of RFD in this patient~     population is indicated.~      Objective: to evaluate the effect of Radio Frequency treatment in patients with chronic~     degenerative neck pain.~      Study design: prospective, randomized, double blinded clinical trial. Study population:~     patients older than 25 years, referred to the University Pain Center of Maastricht and the~     Pain Center of Amphia hospital Breda, with chronic axial neck pain.~      Intervention: patients with at least 3 months of neck pain without radiation to the arm (only~     radiation beyond the shoulder) will be randomized in 2 groups. The first group (RFD + local~     anesthesia-group=intervention group) will receive RF treatment adjacent to the medial branch~     innervating the cervical facet joints after the application of bupivacaine 0.5 ml (0.25%).~     The second group (local anesthesia-group=control group) will only receive the application of~     0.5 ml bupivacaine (0.25%) adjacent to the medial branch. The only difference between the two~     groups is the RF-denervation of the medial branches.~      Main study parameters/endpoints: the primary research question is to evaluate the extent of~     pain reduction induced by RF treatment (RFD + local anesthesia-group=intervention group)~     compared with the local anesthesia-group(control group.~      Following evaluation tools are used : Numeric Rating Scale (NRS), Patient global Impression~     of Change on a 7 point Likert Scale (PGIC), consumption of pain medication (MQS), Patient~     Specific Functional Scale, Quality of life scale (RAND 36), Hospital Anxiety and Depression~     scale (HADS), and Neck Disability Index (NDI, Dutch version).~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: Patients in the RFD + Local Anesthesia-group and Local Anesthesia-group will~     undergo a physical examination before and 6 weeks after the intervention, by an independent~     third party, this will be repeated at 3 and 6 months if abnormalities are observed. At each~     of these time points the patients will receive questionnaires to fill out. A puncture of a~     blood vessel is possible, diagnosed by injection of contrast, for which repositioning of the~     needle is needed. Should accidental intravascular injection of local anesthetic occur, the~     dose used is low and reports show that intravascular injection of bupivacaine 2,5 mg does not~     pose clinical problems. The dura can be punctured; as a consequence contrast will flow in the~     cerebrospinal fluid. The procedure will be stopped and repeated after a few days. In theory a~     lesion of the nerve root is possible, but the needles are designed to avoid this, this~     complication has not been seen since more than 10 years. Up till now, a transient pain is~     occasionally described after the RF treatment. No hypesthesia or motor complications were~     reported. Since the risks of RF treatment are reported low and more related to needle~     placement there is no difference in risk and burden between the two treatment groups.~   "
139352|NCT01743313|"~     Osteoarthritis patients undergoing primary hip and knee replacement are followed-up and~     changes in their glucose metabolism and other metabolic parameters (obesity, cholesterol~     levels) are examined. Persistent postoperative pain is examined as secondary outcome.~   "
139353|NCT01743300|"~     In this prospective pharmacokinetic we investigate the following topics:~        -  The influence of grapefruit juice and orange juice on the steady-state pharmacokinetics~          of sunitinib in cancer patients~        -  The influence of sunitinib on the pharmacokinetics of midazolam in cancer patients~        -  The relationship between Cytochrome-P450-3A4 (CYP3A4) phenotype, as assessed using the~          midazolam clearance test, and the steady-state pharmacokinetics of sunitinib in cancer~          patients~        -  The effect of grapefruit juice and orange juice on CYP3A4 metabolism~   "
139354|NCT01743287|"~     The purpose of this study is to evaluate efficacy and safety of Imotun capsule in~     osteoarthritis of the knee~   "
139355|NCT01743274|"~     Optical Coherence Tomography (OCT) is a recent imaging modality that yields cross-sectional~     images with a resolution 10 times greater than that of intravascular ultrasound (IVUS). OCT~     uses a near-infra-red light source to obtain images of the interior walls of the coronary~     arteries and is increasingly used to evaluate vulnerable atherosclerotic plaques and assess~     placement and response to stenting. - To date, no study has evaluated whether optical~     coherence tomography (OCT) contributes to optimizing percutaneous coronary intervention (PCI)~     and stenting.~      The DOCTORS study is a randomized, open label study to evaluate whether OCT-guided~     angioplasty would provide useful clinical information beyond that obtained by angiography,~     and whether this information would subsequently modify physician behavior and treatment~     choices. In particular, we will evaluate the impact of changes in procedural strategy~     resulting from the use of OCT on the value of fractional flow reserve (FFR) obtained after~     angioplasty and stent implantation of a lesion responsible for non-ST segment elevation acute~     coronary syndromes.~   "
139356|NCT01743261|"~     The aim of this study was to compare the cost/utility ratio of a management model of~     integrated, graded, intensive rehabilitation (GIR) versus usual care (UC) for patients with~     acquired Severe Brain Injury (SBI).~   "
139357|NCT01743248|"~     The surgery of a vestibular schwannoma induces balance disorders which have a an impact on~     the patient's daily life and disrupt their quality of life.~      But the balance disorders don't seem to be the only ones factors that impaired the patient's~     quality of life. It has been alrealdy shown that emotional and psychological factors are also~     related to patient's quality of life.~      This study evaluates the relationship between the balance control compensation and these~     factors (i.e. emotional and psychological) in the vestibular schwannoma resection process.~   "
139358|NCT01743235|"~     A double-blind, randomized, placebo-controlled, dose-finding study to investigate the safety~     and efficacy of Lybridos in the domestic setting in healthy female subjects with hypoactive~     sexual desire disorder and maladaptive activity of sexual inhibitory mechanisms.~      In the present study, the efficacy of Lybridos will be evaluated in the domestic setting in~     healthy female subjects with HSDD and maladaptive activity of sexual inhibitory mechanism(s).~     Sexual satisfaction and other aspects of sexual functioning will be measured within 24 hours~     after each sexual activity. The following hypotheses will be tested:~      Lybridos, as compared to placebo, will significantly increase the number of satisfying sexual~     events.~      The number of satisfying sexual events will not differ significantly between subjects treated~     with placebo and subjects treated with 0.5 mg testosterone alone and/or 10 mg buspirone~     alone.~      Lybridos, as compared to placebo, will significantly increase sexual desire/arousal.~      Sexual desire/arousal will not differ significantly between subjects treated with placebo and~     subjects treated with 0.5 mg testosterone alone and/or 10 mg buspirone alone.~      Lybridos, as compared to testosterone alone and buspirone alone, will significantly increase~     the number of satisfying sexual events and sexual desire/arousal.~   "
139359|NCT01743222|"~     The objective is to determine the safety, tolerability and feasibility of the inguinal~     intralymphatic administration of expanded allogeneic adipose-derived stem cells (eASCs)~   "
139375|NCT01743014|"~     The purpose of this study is to determine whether the combination with ramipril and~     clopidogrel leads to further improvement of endothelial function, reduction of oxidative~     stress and reduction of vascular inflammation, compared with ramipril monotherapy, in~     patients with Diabetes Mellitus type 2 and diabetic nephropathy.~   "
139360|NCT01743209|"~     The main objective of the study is to describe the french population of individuals with~     paraphilia who have committed a sexual offence in whom androgen antagonists was prescribed.~     The secondary objectives are the description of social demographic profiles, the personal and~     family histories,psychiatric co-morbidities, the side effects of androgen antagonists~     treatment. This study, the first of its kind in France, may allow to better understand the~     social demographic and clinical profile of sexual offenders with paraphilias treated with~     androgen antagonists.~      To be included, the subject must have committed a sexual offense and must present a diagnosis~     of paraphilia with an indication of treatment with androgen antagonists. Paraphilia is~     defined by the Diagnostic and Statistical Manual as a sexual behavior disorder characterized~     by sexually arousing fantasies, needs or recurrent and intense sexual behaviors generally~     involving (1) of non-human objects, (2) the suffering or humiliation of oneself or partner,~     (3) children or other persons without their consent, occurring during a period of at least~     six months (Criterion A). This disorder is responsible for sexual behavior which is~     clinically significant disturbances in social, occupational or other important areas of~     functioning (Criterion B).~      The inclusion of approximately 200 subjects is expected in this study. The inclusion period~     will last for 12 months.~      Data will be codified and only a few investigators will have access to these data. The~     statistical analyse will use the usual descriptive parameters: mean, standard deviation,~     median, interquartile range and range for quantitative variables, frequencies and cumulative~     frequencies (if applicable) for qualitative variables.~   "
139361|NCT01743196|"~     The purpose of this study is to determine if there is a difference in the short term response~     in serum folate after a single dose of folic acid in normal weight and obese women of~     childbearing age.~   "
139362|NCT01743183|"~     This study aims to evaluate pulmonary function and respiratory muscle strength in a group of~     elderly women with hypertension before and after a respiratory muscle training.~   "
139363|NCT01743170|"~     The proportion of hypertensive patients achieving adequate blood pressure control meeting~     guideline targets remains low. Of hypertensive patients, only 50% are on antihypertensive~     medications. Of those on blood pressure lowering drugs, only 50% have their blood pressure~     controlled.~      The objectives of this study are:~        1. To test the feasibility of telemonitoring of blood pressure in Flemish general~          practices.~        2. To investigate in a randomized fashion whether telemonitoring enabled self-measurement~          of blood pressure leads to faster blood pressure control than self-measurement without~          the telemonitoring information.~        3. The secondary endpoints include various blood pressure indexes, adverse effects, a~          simple assessment of quality of life, adherence, a log of technical problems, and cost~          effectiveness (EQ-5D-5L).~   "
139364|NCT01743157|"~     A phase I-II study of treatment of metastatic melanoma using induction therapy with~     Biochemotherapy plus Bevacizumab followed by consolidation therapy with Ipilimumab (BBI).~   "
139365|NCT01743144|"~     Rationale:~      Pediatric Adenotonsillectomy is a common procedure of brief performed on a day-case basis, in~     which rapid recovery with safe airway after extubation is crucial. Sevoflurane is considered~     the inhaled anesthetic of choice in such procedures, however it has been reported that~     emergence agitation (EA) is a frequent complication in 30-80% of children receiving~     sevoflurane general anesthesia. The possible effect of magnesium sulphate on decreasing the~     incidence of EA in children was not adequately investigated.~      Objective:~      To assess the possible effects of intraoperative intravenous magnesium sulphate (MgSO4)~     infusion on the incidence of sevoflurane-induced EA in children undergoing~     adenotonsillectomy.~      Study population and sample size:~      Children 4-7 years, ASA physical status I or II, undergoing Adenotonsillectomy under~     sevoflurane general anesthesia. 64 patients (32/group) is required to detect a significance~     difference of 40% in the incidence of agitation between two groups, with a power of 80% and~     alpha error of 5%.~      Study design:~      A double blind, randomized, placebo controlled study.~      Method:~      In the placebo group, a normal saline bolus dose 0.3ml/kg will be iv infused followed by a~     continuous infusion of 0.1 ml/kg/h. In the MgSO4 group, a MgSO4 bolus dose 0.3mL/kg will be~     iv infused followed by a continuous infusion of 0.1 ml/kg/h. infusion terminated by the end~     of surgery. Post operative emergence agitation will be assessed by using the Pediatric~     Anesthesia Emergence Delirium scale.~      Possible risks:~      Drug side effects such as facial warmth, flushing, dry mouth, and malaise.~      Outcome parameters:~      The primary outcome: incidence of sevoflurane-induced EA measured using the Pediatric~     Anesthesia Emergence Delirium (PEAD). Secondary outcome: postoperative pain and rescue~     analgesic requirements, perioperative hemodynamics, durations of recovery, postoperative~     complications~      Statistical analysis plan:~      Student's t-test or Mann Whitney-U and Chi square or Fisher's exact tests will be used as~     appropriate. The possible relationship between EA and pain scores will be evaluated with the~     use of Spearman's rank correlation coefficient~      Time plan:~      6-9 months.~   "
139366|NCT01743131|"~     This is a phase II multi-center, randomized, double blind, placebo-controlled trial.~      The investigators are doing this study to see if a new drug, abatacept, can be used together~     with a calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate to provide better~     protection against Acute Graft versus Host Disease (aGvHD) without causing more infections.~      Funding Source - FDA OOPD~   "
139367|NCT01743118|"~     The current most important topical treatments for psoriasis are vitamin D3 analogues and/or~     corticosteroids. The possibility of another effective treatment for psoriasis could be based~     on the immunosuppressive efficacy of selective blockers of a lymphocyte potassium channel.~      The aim of the clinical trial is to evaluate the safety, tolerability and anti-psoriatic~     efficacy of topical SPS4251 formulations in comparison to placebo and to a marketed topical~     Vitamin-D analogue ointment in a psoriasis plaque test.~   "
139368|NCT01743105|"~     The main objective of this study is to evaluate the inter-rater reproducibility of~     diaphragmatic excursion measures via time-motion-mode ultrasound (evaluation performed on the~     first measure) in patients experiencing acute respiratory distress emergencies.~   "
139369|NCT01743092|"~     Research specific to women's gambling treatment needs is limited but suggests a critical need~     for women sensitive options and reduced barriers to access. This pilot will test the~     effectiveness of a Tutorial Workbook (TW) both as a self-help tool and used in combination~     with a webinar. Ontario women(n=48) over the age of 19, with gambling concerns, will be~     recruited through flyers, on-line and newspaper ads and randomly assigned to one of two~     groups: (a) TW or (b) TWW (TW plus Webinar). All will complete questionnaires addressing~     gambling behaviours, personal history and mood states prior to and after the 12 week study.~     Groups (a) and (b) will also provide feedback on the TW's content and relevance. Group (b)~     will, in addition, provide feedback on the Webinar Group. TW and TWW will be valuable~     additions to current treatments, of special importance to reduce barriers for women. The~     study will contribute to best practices in developing web-based treatments.~   "
139370|NCT01743079|"~     The purpose of this study is to evaluate the efficacy and safety of telbivudine and~     lamivudine use during late pregnancy for the prevention of HBV perinatal transmission in~     highly viraemic mothers.~   "
139377|NCT01742988|"~     This is a phase I, open-label, dose-escalation study of CUDC-907 in patients with refractory~     or relapsed lymphoma or multiple myeloma. CUDC-907 is a multi-targeted agent designed to~     inhibit phosphoinositide 3-kinase (PI3K)and histone deacetylase (HDAC). The study is designed~     to assess the safety, including the maximum tolerated dose, biologically effective dose, the~     pharmacokinetics, and the anti-cancer activity of CUDC-907.~   "
139378|NCT01742975|"~     A randomized prospective simple-blind interventional study evaluating the efficacy of the~     synthetic adhesive solution Ifabond, in patients undergoing breast cancer surgery. The main~     objective of this study is to determine if the application of Ifabond, in addition to the~     conventional method of breast surgery, reduces the postoperative seroma formation. The~     secondary objective is to assess quality of life immediately after surgery, and the need for~     needle aspiration of the axilla, when using Ifabond.~   "
139379|NCT01742962|"~     The purpose of this exploratory data collection is to strengthen our knowledge of some of the~     rarer distresses following surgical removal of the prostate. In general these are:~        -  Side effects related to sexuality, including:~        -  Altered perception of orgasm,~        -  Orgasm associated pain,~        -  Penile shortening and deformity.~        -  Side effects related to urinary incontinence.~        -  Urinary tract infection after operation.~        -  Influence of distress on sexual quality of life.~        -  Influence of distress on the patient´s sex drive.~      In addition information on a range of demographics and information on the patient´s erectile~     function will be collected.~   "
139380|NCT01742949|"~     This study aims to investigate the benefits of using first line heated humidification. The~     primary objective of this research is to determine the effect of high levels of~     humidification delivered by ThermoSmart™ on CPAP adherence. In addition, to determine if it~     is possible to predict which patients benefit the most (i.e. be more adherent with therapy)~     from high levels of humidification delivered by ThermoSmart.~   "
139381|NCT01742936|"~     The current study proposes to investigate Point of Care Testing (POCT) (Coagcheck®) and~     compare obtained results versus standard laboratory coagulation parameters prothrombin time~     (PT) and partial thromboplastin time (PTT). The time difference in obtaining the two results~     will also be examined. A total of 100 pediatric patients undergoing spinal surgery or~     cardiopulmonary bypass will be enrolled and consented per protocol. Blood samples will be~     obtained simultaneously tested on both the standard laboratory apparatus and the Coagcheck®~     device. If the two results are comparable, this could have immediate clinical application and~     impact in the operating room as POCT results are available within 2-3 minutes compared to 1-2~     hours for standard laboratory samples.~   "
139382|NCT01742923|"~     Patients with hypertension have an increased risk of stroke and myocardial infarction.~     However, poor adherence to treatment with antihypertensives and lipid-lowering agents occurs~     frequently within this patient group. The purpose of this study is to investigate whether a~     complex tailored intervention in a hospital setting will lead to increased medication~     adherence and fewer cardiovascular events when compared to a usual care group. Interventions~     focus on motivational interviewing, medication review and telephone follow up.~   "
139383|NCT01742910|"~     Age-related cataract is the main cause of impaired vision in the elderly population~     worldwide. In the UK, more than half of people who are over 65 have some cataract development~     in one or both eyes. The only treatment that can restore functional visual ability is~     cataract surgery where the opacified crystalline lens is removed by phacoemulsification and~     an artificial intraocular lens is implanted. It is estimated that around 10 million cataract~     operations are performed around the world each year. Cataract operations are generally very~     successful, with a low risk of serious complications. The most common risk is developing a~     condition called posterior capsule opacification (PCO), which causes impaired vision to~     return.~      During the past two decades, cataract surgery underwent tremendous change and modernisation~     resulting in today's small incision phacoemulsification surgery and a safe technique with a~     short rehabilitation time for the patient. The most frequent long-term complication of~     cataract surgery remains to be posterior capsule opacification (PCO). In the past few years,~     refinements in surgical technique and modifications in IOL design and material have led to a~     decrease in the incidence of PCO.~      It has been shown that a sharp posterior optic edge inhibits migration of lens epithelial~     cells (LEC) behind the IOL optic and therefore have a lower incidence of posterior capsule~     opacification (PCO). Most IOL designs have open-loop haptics that are connected to the optic~     towards the end of the production process, also called multipiece designs.~      For several reasons such as better ease of use with injector systems and higher efficiency in~     the production process, companies have developed IOLs with open-loop haptics out of one block~     of material, also called single-piece designs. In the case of such single-piece IOLs, the~     haptics tend to be much thicker than with multipiece IOLs. A potential drawback of the thick~     haptics maybe an incomplete closure of the capsule at the optic rim with a reduced bending~     effect of the posterior capsule around the posterior optic edge. Additionally, the posterior~     sharp edge is often discontinuous in the region of the haptic-optic junctions. These~     locations may serve as a scaffold for LECs to migrate behind the IOL optic resulting in PCO.~     Nowadays a multitude of different single piece IOLS are available, many of them similar but~     of course with some differences in regard to the chemical composition of the acrylic material~     and the IOL design.~      The purpose of this study is to compare the intensity of posterior capsule opacification~     (PCO) between two different 1-piece foldable hydrophobic acrylic intraocular lenses (IOLs)~     with different design of the sharp posterior edge within a follow up period of three years.~   "
139384|NCT01742897|"~     The purpose of this study is to evaluate the efficacy and safety of Transdermal therapeutic~     system (TTS) fentanyl patches (transdermal patch containing a drug that is put on the skin so~     the drug will enter the body through the skin) in knee osteoarthritis (disorder, which is~     seen mostly in older persons, in which the joints become painful and stiff) participants with~     moderate to severe pain.~   "
139385|NCT01742884|"~     The purpose of this study is to determine if Thealoz is effective in Dry Eye Syndrome exposed~     to controlled adverse environmental conditions.~   "
139386|NCT01742871|"~     Bleeding under vitamin K antagonists are a major iatrogenic causes of hospitalization,~     subject to a fatal outcome in more than one third of cases, mortality is particularly high in~     cases of serious bleeding, including intracerebral hemorrhage. If the INR measured in these~     patients are often away from the higher value of the target range, a significant proportion~     of bleeding were observed for INR between 2 and 3. The study captures the components of the~     nutritional status of patients on oral anticoagulants, including any micronutrient~     deficiencies, to determine whether nutritional status is an independent risk factor for~     bleeding~   "
139387|NCT01742858|"~     Establish normative data of ElMindA's Brain Network Activation (BNA) using evoked response in~     three age groups.~   "
139402|NCT01742663|"~     The objective of this study is to compare the relative efficacy and safety of the test~     formulation diclofenac sodium gel 3% (Taro Pharmaceuticals Inc.) to the marketed formulation~     Solaraze® (diclofenac sodium) Gel 3% (Fougera Pharms) in the treatment of actinic keratosis.~      Both the test and reference formulations will also be compared to a placebo formulation to~     test for superiority.~   "
139388|NCT01742845|"~     The aim of this prospective, randomised, controlled study is to compare the efficacy of~     ultrasound-guided intermediate cervical block to superficial block for carotid~     endarterectomy.~      Patients scheduled for carotide endarterectomy under regional anaesthesia (ropivacaine 4.75~     mg/ml) are randomised into 2 groups according to the technique of anaesthesia performed:~     superficial cervical block (Control group) or, ultrasound guided intermediate cervical block~     (Echo group). Main outcome is cervical block success, defined by surgery performed under~     regional anaesthesia without supplemental topical lidocaine. Secondary outcomes are rate of~     conversion to general anaesthesia, total dose of supplemental topical lidocaine and~     block-related complications.~   "
139389|NCT01742832|"~     The purpose of this study is to evaluate the safety and effectiveness of vilazodone for the~     treatment of major depressive disorder versus citalopram. Doctors want to determine if~     vilazodone is effective for the treatment of major depressive disorder in those who have not~     responded to generic selective serotonin reuptake inhibitors (SSRI), which is a class of~     anti-depressant drugs such as Prozac, Lexapro, Paxil, or Zoloft. Both vilazodone and~     citalopram have been approved for the treatment of major depressive disorder. This research~     is being done because the researchers want to find out if vilazodone works in reducing the~     symptoms of depression significantly more than a generic SSRI.~   "
139390|NCT01742819|"~     Glaucoma is one of the leading causes of blindness in the world. The key to prevention of~     visual loss from glaucoma is early detection of the disease or its progression and timely~     treatment. The proposed study will investigate the role of various tests in improving~     detection of disease progression in advanced glaucoma. Evaluation of the peripheral field of~     vision (visual field examination) remains the current standard for detection of progression~     in glaucoma. However, there is a lot of variability or inconsistency in eyes with advanced~     glaucoma, which could make it difficult to detect worsening of glaucoma with visual fields.~     The optic nerve demonstrates significant damage in such eyes and hence oftentimes repeat~     imaging of the optic nerve head is not helpful for detection of change. Therefore, imaging of~     the central retina (the innermost sensitive tissue lining the inside of the eye), called~     macula, has been proposed to supplant imaging of the nerve in eyes with severe glaucoma. The~     macula aids in detailed central vision. Since the macular retinal neural cells are the last~     ones to be affected in glaucoma, measurement of macular retinal thickness could provide~     significant information with regard to the course of glaucoma. In the proposed study,~     glaucoma patients will be tested and followed with various measurements done with newer~     versions of optical coherence tomography (OCT) imaging and visual field machines. The~     patients will undergo repeat imaging and visual field testing every 6 months over the course~     of 5 years. Rates of change will be estimated. We will explore if changes in various outcome~     measures derived from imaging are correlated with the corresponding visual field changes in~     glaucoma, and whether the former can be used as an alternative method for detecting~     simultaneous or subsequent glaucoma progression. The hypothesis for this proposed research is~     that macular OCT parameters are valid structural measures that can be used especially in~     advanced disease to follow the course of glaucoma.~   "
139391|NCT01742806|"~     This study is to evaluate if Bio-absorbable Felt(NEOVEIL®) makes the amount of exudate reduce~     and shortens time until drain removal after minimally invasive surgery for early gastric~     cancer.~   "
139392|NCT01742793|"~     The study hypothesis is that lenalidomide and romidepsin (and dexamethasone for patients with~     myeloma) will have an acceptable toxicity profile and that in combination will have~     sufficient activity in the target population (including those previously refractory to HDACi~     monotherapy) to warrant further investigation.~   "
139393|NCT01742780|"~     The purpose of this study is to determine if there is one method of identifying the proximal~     humerus intraosseous vascular access site that is easier for clinicians to use, out of the 4~     methods being evaluated.~   "
139394|NCT01742767|"~     Cisplatinum and pemetrexed (ALIMTA®) has become an effective first-line regimen for advanced~     and inoperable non-squamous NSCLC without somatic activating mutations of epidermal growth~     factor receptor (EGFR). In the standard regimen the cisplatinum dose is 75 mg/m2 on day 1 of~     a 21-day cycle. Due to the high platinum-dose patients do need a strict hyperhydration and~     often have to be hospitalized for survey. Split-dose cisplatinum with two administrations on~     Day 1 and 8 of a 21-day-cycle has already been administered in other platin-containing~     chemotherapy regimens (cis/gem cis/nav cis/paclitaxel cis/docetaxel) with favourable toxicity~     profiles and generally with an excellent patient compliance.~   "
139395|NCT01742754|"~     Fecal microbiota therapy (FMT) is an emerging treatment for gastrointestinal disorders marked~     by an imbalance in the intestinal microbial flora (dysbiosis). It is hypothesized to work by~     shifting the recipient's microbiota toward a eubiotic microbial community that resists~     colonization by pathogenic organisms or decreases its inherent inflammatory properties.~     Several studies now report its efficacy in treatment of severe Clostridium difficile colitis.~     Preliminary studies using FMT in Ulcerative Colitis (UC) have also met with some success.~     This is corroborated by several lines of evidence suggesting dysbiosis plays an important~     role in UC pathogenesis. While a recent study using FMT in patients with irritable bowel~     syndrome (IBS) and constipation found transplants persist for up to 2 years, the extent to~     which the microbiota is alterable in UC is not known. Indeed, there may be particular genetic~     or immunologic factors in UC leading to selection pressure preventing a change in the~     microbiota. As an initial step into investigating the potential efficacy of stool transplants~     for Ulcerative Colitis (UC), the investigators propose to determine the feasibility and~     stability of transplanted microbiota in a series of 10 patients with mild to moderate UC.~   "
139396|NCT01742741|"~     An unblinded, randomized, cross-over design with each patient participating in two 40-hour~     outpatient admissions: (a) Experimental involving automated Control-to-Range (CTR) and (b)~     Control using Continuous Glucose Monitor (CGM)-augmented insulin pump treatment outside of a~     hospital based clinical research center.~   "
139397|NCT01742728|"~     we analyzed the relationship between oxidative stress, immunoglobulin G antibody titers,~     cytokines, and periodontitis through community-based study held in the Goto city, Japan.~   "
139398|NCT01742715|"~     To compare the best Positive End Expiratory Pressure (PEEP) as determined by one of three~     commonly used clinical approaches for best PEEP determination, with PEEP guided by the ARDS~     network algorithm.~   "
139399|NCT01742702|"~     The primary aim of the present study was to examine the haemodynamic changes in primary~     hypertension and secondary hypertension (renal diseases, endocrine diseases,~     obesity-associated hypertension) with a non-invasive haemodynamic measurement protocol~     utilizing radial pulse wave analysis and whole-body impedance cardiography in both supine~     position and during head-up tilt. For comparison, haemodynamics of subjects with chronic~     fatigue syndrome will also be recorded.~   "
139400|NCT01742689|"~     In this study we will compare pain intensity and side effects at different time points after~     the intranasal administration of desmopressin or placebo in patients with acute renal colic~     pain.~   "
139451|NCT01742026|"~     ADVANCE THERAPY ASPERGILLOSIS INVASIVE BY PCR DETECTION~   "
139403|NCT01742650|"~     The aim of our study is to compare two different syndesmosis transfixation methods in AO/OTA~     Weber C ankle fractures. Our hypothesis is that 50% of screw fixed fibulas but only 5% of~     suture-button fixed fibulas are in malposition. All skeletally mature patients (16 years or~     older) with AO/OTA Weber C type fractures operated within a week after trauma are~     consecutively included into the study. The tibiofibular transfixation is randomly performed~     either by a 3,5 mm tricortical screw or a suture-button (TightRope). Malposition of the~     tibiofibular joint is assessed in an intraoperative computed tomography. Clinical outcome is~     assessed by using Olerud-Molander, RAND ja 36-Item Healt Survey after 1-year from the injury.~   "
139404|NCT01742637|"~     The objective of this study is to evaluate the therapeutic equivalence and safety of~     Adapalene and Benzoyl Peroxide 0.1%/2.5% Gel (Taro Pharmaceuticals Inc.) and Epiduo®~     (Adapalene and Benzoyl Peroxide 0.1%/2.5% Gel) (Galderma Laboratories, L.P.) in the treatment~     of acne vulgaris, and to demonstrate the superiority of the efficacy of the test and~     reference products over the vehicle (placebo) control in the treatment of acne vulgaris.~   "
139405|NCT01742624|"~     To investigate the efficacy, safety, and drug compliance of Advagraf® (Extended Release~     Tacrolimus) by comparing the Advagraf® + steroid + Mycophenolate Mofetil combined therapy and~     the Prograf® + steroid + Mycophenolate Mofetil combined therapy in de novo kidney recipients~     1 month after kidney transplantation.~   "
139406|NCT01742611|"~     This is a multi-center, open-labeled, non-comparative study to examine the safety and~     efficacy of ASP1585 for long-term dosing in chronic kidney disease patients with~     hyperphosphatemia not on dialysis.~   "
139407|NCT01742598|"~     The purpose of this study is to assess the safety and performance of the 23mm Portico~     Transcatheter Heart Valve and the TAVI Transapical Delivery System in subjects with severe~     symptomatic aortic stenosis~   "
139408|NCT01742585|"~     This is a randomized, double blind, placebo-controlled multi-center study to examine the~     efficacy and safety of ASP1585 in chronic kidney disease patients with hyperphosphatemia not~     on dialysis.~   "
139409|NCT01742572|"~     Several studies have shown differences in health-related outcomes by dietary pattern. These~     patterns have included those participants following vegan (no meat, poultry, fish, dairy, or~     eggs), vegetarian (no meat, poultry, or fish), pesco- vegetarian (no meat or poultry),~     semi-vegetarian (red meat and poultry ≥ 1 time/month and < 1 time/week), or omnivorous diets.~     These studies have shown that of these dietary patterns, vegans have the lowest BMIs, lowest~     prevalence of Type 2 diabetes, and lowest amount of weight gain over 5 years. In addition,~     vegetarians have significantly better metabolic risk factors as compared to non-vegetarians.~     While these initial observational studies have shown benefits to consuming more plant-based~     diets, there have been no randomized trials examining the differences in health outcomes~     among these dietary patterns. To begin exploring this research area, the investigators will~     conduct a pilot study which will randomize participants to one of the 5 dietary approaches.~     Participants (n=75) in the NEW DIETs Study will be recruited to follow their randomly~     assigned diet for 8 weeks and attend weekly sessions to learn about nutrition and cooking.~   "
139410|NCT01742559|"~     Anesthesia of the soft and hard tissues in the maxilla may require up to five injections.~     Thus, the aim of the present study was to evaluate the anesthetic efficacy in buccal tissues~     after the use of the anterior middle superior alveolar (AMSA) and supraperiosteal techniques~     during subgingival scaling and root planning (SRP).~   "
139411|NCT01742546|"~     To assess the effectiveness of therapeutic ultrasound combine transcutaneous electrical nerve~     stimulation (TENS) and therapeutic ultrasound in treatment of myofascial pain syndrome in~     upper trapezius muscle measured by mean change between pre and post treatment of pressure~     pain threshold (PPT), patient's complaint in pain intensity and the number of total tablet~     usage of acetaminophen in both groups.~   "
139412|NCT01742533|"~     Premature ovarian failure (POF) refers the occurrence of amenorrhoea, elevated serum~     gonadotrophins and hypoestrogenism levels in female before the age of 40. It has important~     physical and psychological consequences/impact in those patients.~      Premature ovarian failure (POF) is currently managed by non-physiological sex steroid~     regimens which are inadequate at optimizing uterine characteristics.~      Human umbilical cord mesenchymal stem cells (hUCMSCs) and human cord blood mononuclear cells~     (hCBMNCs) have been shown to have the ability to modulate the immune response and enhance~     angiogenesis, suggesting the novel and promising therapeutic strategy for POF.~      In this study, the safety and efficacy of hUCMSCs and hCBMNCs transplantation combined with~     Hormone Replacement Therapy will be evaluated in patients with Premature Ovarian Failure.~     Participants will be followed for an expected average of 48 weeks.~   "
139413|NCT01742520|"~     The purpose of this study is to determine the effect of sucrose 24% for pain prevention on~     preterm infants. Our hypothesis is that repeated doses of sucrose 24%, given prior to painful~     procedure,do not impair neurodevelopmental outcomes of preterm infants~   "
139414|NCT01742507|"~     Stent coverage and neo-intimal growth can be evaluated in-detail by intracoronary optical~     coherence tomography (OCT), which is a catheter-based imaging technique. It is performed as~     part of the PCI procedure. OCT is the optical analogue of intravascular ultrasound (IVUS),~     except that it can provide much higher resolution of coronary cross sectional images than~     IVUS. The LightLab C7XR OCT system (Frequency Domain OCT) used in this Hospital has obtained~     full CE Mark, approved by the US FDA, and approved for clinical use in Hong Kong. It has been~     shown to be safe in clinical settings and has been used in over 300 patients without~     complication at Queen Mary Hospital.~      In this study, stent coverage and neo-intimal growth between zotarolimus-eluting stents (ZES)~     and biolimus-eluting stents (BES) will be compared by using OCT at 9 month and specific~     post-intervention re-study intervals.~      The investigators objective is to investigate the clinical impact and OCT difference on early~     stent healing and late lumen loss between the two new-generation limus-eluting-stents -~     Resolute Integrity and Biomatrix, which differ in stent design, eluting drug and coating~     polymer.~   "
139415|NCT01742494|"~     Peroral endoscopic myotomy (POEM) has recently been introduced as promising alternative to~     laparoscopic Heller myotomy for patients with idiopathic achalasia. Several technical~     modifications have been proposed but have not yet been tested in randomized trials.~   "
139416|NCT01742481|"~     The proposed study is part of a career development award. The first two phases of research~     involve collaborating with adult survivors of childhood cancer representing both sexes and~     three ethnic/racial groups (African American, Hispanic, and White). THe collaboration will~     focus upon developing educational material that is helpful in teaching survivors about health~     risks related to cancer treatments and about survivorship care. The third phase is a~     randomized controlled trial that will randomly (like a flip of coin)place survivors into one~     of two groups. One group will meet in -person with a group leader three times, once each week~     over three weeks. The other group will receive an information packet that contains websites,~     books, and resources similar to content provided in-person within a group format to the other~     group. The goal is to help adult survivors get involved in specialized healthcare so they can~     remain healthy. This involves getting a copy of their medical record to understand what~     treatments they received and working with health providers to get an individualized~     survivorship care plan.~   "
139417|NCT01742468|"~     The study was performed to investigate the effects of a daily consumption of n-3 LC-PUFA~     supplemented products (sausage, tomato spread, milk beverage) on disease activity,~     inflammatory markers, and cardiovascular risk factors in patients with rheumatoid arthritis.~   "
139418|NCT01742455|"~     Concerning the promotion of peripheral collateral growth, clinical studies investigating new~     therapeutic strategies have used imprecise assessment methods and therefore determined only~     weak endpoints. In contrast to the coronary circulation, there is currently no gold~     standard available to document successful promotion of collateral growth in patients~     suffering from peripheral artery disease. Therefore, the purpose of this study is to evaluate~     a new invasive method to quantify arterial collateral flow in the lower extremity in patients~     undergoing elective coronary angiography.~   "
139419|NCT01742442|"~     About 50% of cancer patients are >70 years at diagnosis. Age related somatic and psychiatric~     problems may influence the course of cancer and its treatment. The present study is a~     prospective observational study. Age related problems will be assessed by clinical frailty~     indicators covering areas that are recommended in geriatric oncology. The aim is to describe~     the frequency of age related problems in a cohort of Norwegian cancer patients > 70 years of~     age, to investigate the predictive/prognostic impact of these indicators on cancer and~     treatment related morbidity and mortality, and to investigate the association between~     clinical frailty indicators, sarcopenia (severe loss of muscle mass) and inflammatory~     response. Patients are recruited at outpatient cancer services, Innlandet Hospital HF (SI),~     Oslo University Hospital, and Akershus University Hospital. Estimated sample size is 300 with~     30 months inclusion and 2 years follow-up. The study emerges from SI in collaboration with~     several external national and international centres~   "
139420|NCT01742429|"~     To test the efﬁcacy of 14 day levoﬂoxacin and bismuth-containing second-line therapy for~     resistant Helicobacter pylori infection, to compare with the classical quadruple therapy.~   "
139421|NCT01742416|"~     Arterial cannulation is a commonly performed invasive procedure in the operation room, the~     emergency department, and in the intensive care unit. The indications include the need for~     continuous blood-pressure monitoring, frequent arterial blood-gas analysis, and repeated~     blood sampling for laboratory evaluation. This procedure can be challenging even in the best~     of hands. Traditionally, the artery is located by feeling the pulse of the patient. The pulse~     may, however be weak or absent in patients with hypotension, edema, obesity or local~     thrombosis due to previous arterial cannulation in the same location. Furthermore, the~     catheter may not be passed successfully into the artery, despite apparent good blood return~     on initial puncture, or hematoma and spasms of the artery may develop after failed attempts,~     thus making further attempts even more difficult. While ultrasound (US) is being used with~     increasing frequency for central venous access, fewer clinicians are familiar with US-guided~     arterial catheterization. The aim of this study is to investigate if ultrasound facilitates~     arterial cannulation in children ≤24 months compared with the palpation method and to~     investigate the potential extra costs/savings of introducing the method. This study~     hypothesizes that the ultrasound method will facilitate arterial cannulation in small~     children compared with the palpation method.~   "
139422|NCT01742403|"~     This study is investigating measurement of prostate motion during radiotherapy using the~     implanted gold markers. If motion is greater than 3mm then the beam will be stopped and~     position corrected (gating).~   "
139423|NCT01742390|"~     This trial designed to investigate the effect of switching to aripiprazole from risperidone~     or paliperidone on reverse prolactin level, and consequently improve sexual dysfunction in~     adult patients with schizophrenia spectrum disorders and bipolar spectrum disorders.~   "
139424|NCT01742377|"~     The purpose of this study to assess efficacy of SE endoscopy in the detection of MCE in~     dyspeptic patients with or without GERD diagnosed by GerdQ or by endoscopy + PHM and in~     normal volunteers.~   "
139425|NCT01742364|"~     The study is designed to test the hypothesis that BCG administration via jet injector will~     produce a comparable immune response and that there will be no significant differences in~     safety or reactogenicity between BCG administration via jet injector and needle and syringe.~      The primary objectives of this study are to...~        1. Compare the safety and reactogenicity of BCG administered intradermally by a jet~          injector device in adults and infants, to BCG administered intradermally by needle and~          syringe;~        2. Compare the specific T cell immunity in neonates vaccinated with BCG via the jet~          injector device to infants vaccinated with BCG via needle and syringe.~   "
139426|NCT01742351|"~     The aim of the study is to test the feasibility and acceptability of internet-based Cognitive~     Behaviour Therapy (CBT) for persons diagnosed with bipolar disorder, type II. The idea is to~     treat residual depressive symptoms as well as using psychoeducation to improve their~     prognosis. Each participant will have a personal therapist that will provide guidance and~     support throughout the treatment.~   "
139427|NCT01742338|"~     COPD (chronic obstructive pulmonary disease) is a long-lasting lung disease usually caused by~     long-term smoking. COPD can get worse, making people sick enough to need hospitalization.~     Corticosteroids are very effective and are almost always used, but nobody knows the right~     dose. High doses may work better but could cause more side effects than low doses. Typical~     treatment lengths last at least one week. This study will be comparing two common regimens:~     either 40mg of corticosteroids daily (low dose), or 80mg of corticosteroids daily (high~     dose). It is unknown which regimen works better..~   "
139428|NCT01742325|"~     Specific aims:~      Control group(2010/1~2011/6)： Aim 1: Describe the patterns of fatigue, sleep disturbance,~     and pain in children with cancer from perspectives of children and their parents over the~     course of one cycle (five days) of inpatient chemotherapy (CXT).~      Aim 2: Determine, at various time points (during they are hospitalization various four~     times), the associations between fatigue, sleep disturbance, and pain over the course of four~     cycles (there are five days in each cycle) of CTX in children with cancer.~      Aim 3: Examine the associations between a symptom cluster of fatigue, sleep disturbance,~     pain, child reported Quality of Life for Children with Cancer (QOLCC), parent reported~     uncertainty and QOL, and biomarkers over the course of four cycles of CXT in children with~     cancer.~      Intervention group(2011/7~2012/12)： Aim 4: To test an intervention program (two 20-minute~     sessions of walking around the nurse's station daily, five days a cycle) to reduce the~     symptoms of fatigue and pain and increase quality of sleep.~   "
139429|NCT01742312|"~     Curative treatment for oesophageal cancer involves undertaking chemotherapy followed by an~     operation to remove the tumour. Chemotherapy has several effects upon the body, including~     effects upon the systems that control the creation and breakdown of muscle. We aim to review~     these effects by recording changes in the amount of exercise patients are able to undertake~     after chemotherapy and reviewing changes in muscle mass.~   "
139430|NCT01742299|"~     The purpose of this study is to allow continued use of imatinib in patients who are on~     imatinib treatment in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs~     (CD&MA) study and are benefiting from the treatment as judged by the investigator.~   "
139431|NCT01742286|"~     The purpose of this study is to estimate the maximum tolerated dose and/or recommended dose~     for expansion of LDK378 as a single agent, assess safety, tolerability and anti-tumor~     activity and characterize single and multiple-dose pharmacokinetics when administered orally~     to pediatric patients with ALK-activated tumors, with and without food.~   "
139432|NCT01742273|"~     Patients on hemodialysis (HD) exhibit an immensely increased cardiovascular mortality~     associated with extensive vascular calcification (VC). In the past years the development of~     VC was discovered to be actively regulated and as being influenced by inhibitors of~     calcification (e.g. matrix-Gla-protein, fetuin-A). MGP is produced by vascular smooth muscle~     cells and needs post-translational modification by vitamin K dependent gamma-carboxylation to~     be fully active. Based on the demonstration of increased PIVKA-II levels, about 97% of all HD~     patients exhibit insufficient carboxylation activity. We therefore aim in this randomized,~     controlled study to retard the progress of coronary and aortal calcification as assessed by~     thoracic multislice-CT by the thrice weekly administration of 5 mg vitamin K1 (phylloquinone)~     to about 100 HD patients over a period of 18 months.~   "
139433|NCT01742260|"~     Formal study hypothesis:~      Cranial reconstruction using mesenchymal stromal cells and resorbable biomaterials, will~     result in the patient producing their own bone to fill the void which will reduce the risk of~     infection and resorption, lead to a better cosmetic result and obviate any long term~     consequence of having a synthetic material in vivo.~      Introduction:~      There are several reasons that parts of the skull may need to be removed:~        -  After trauma to relieve brain swelling~        -  During brain surgery (for brain cancer)~        -  After trauma where the bone is so badly fractured/fragmented it needs to be removed.~      In all but the last case the bone flap is temporarily stored in a freezer and once the brain~     swelling has subsided it is reinserted. This procedure is called autologous cranioplasty;~     autologous, because it originally came from the patient and cranioplasty, referring to the~     repair. Although this is a straightforward procedure, there are a number of complications~     including infection and bone resorption that can occur.~      This study:~      Stromal cells have a proven ability to aid in bony healing. Furthermore stromal cells on a~     ceramic framework encased in a plastic scaffold have been shown in a small clinical trial to~     lead to healing of skull defects. In the present study, it is proposed to add stromal cells~     from a suitable donor to medical grade ceramic granules, place them in between specially~     moulded plastic scaffolds and insert the sandwich into the skull. Both the ceramic and~     plastic materials are medical grade and commonly used in reconstructive surgery, the ceramic~     for packing into bony defects due to trauma or removal of cancer and the polymer in bony~     reconstruction. Both materials are approved by the TGA. They are designed to dissolve away~     over time as the body's own blood vessels and cells populate the sandwich and create the~     patient's new bone. It has been proven that without the encouragement of the cells and~     temporary scaffold materials, a hole in the skull will not heal. Given the incidence of bone~     resorption/infection and metal plate infection using traditional methods, it would seem~     prudent to provide a construct that will allow controlled replacement with the patient's own~     bone, thus negating any adverse long-term complications with synthetic materials that remain~     for life.~   "
139434|NCT01742247|"~     Assessment of needs of moisturizers after various laser treatments~   "
139435|NCT01742234|"~     An organ transplant is frequently the best option and, in some cases, the only option to save~     the lives of transplant recipients. Receiving an organ from a living donor eliminates the~     need to wait for a deceased donor, an option that many transplant recipients do not survive.~     However, donating an organ presents health concerns to the donor as well. This study will use~     surveys to evaluate the understanding of risk and psychological pressure that living organ~     donors felt when making the decision to donate. It will also compare participants' answers~     across geographic, racial and socio-economic backgrounds.~   "
139436|NCT01742221|"~     This trial is designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of~     HemaMax in healthy male and female volunteers.~   "
139437|NCT01742208|"~     This Phase 2 study is intended to assess the pharmacodynamics (PD), pharmacokinetics (PK),~     safety and efficacy of LX4211 following daily oral administration for 29 days in patients~     with type 1 diabetes mellitus (T1DM).~   "
139438|NCT01742195|"~     The aim of this study is to determine if the insertion of the linear endobronchial ultrasound~     bronchoscope is more comfortable for patients when done through the nose compared to its~     insertion through the mouth. Our hypothesis is that nasal insertion is more comfortable.~   "
139439|NCT01742182|"~     Disruption of sleep and alertness is one of the most disabling non-motor symptoms of~     Parkinson's disease (PD). Mechanisms leading to impaired sleep and alertness in PD are not~     well understood, and treatment options remain limited. The proposed research will examine~     markers of the circadian system, sleepiness and sleep quality in PD patients and healthy~     controls. Further, the project will examine effects of bright light exposure on circadin~     function, sleep and alertness in PD.~   "
139452|NCT01742013|"~     GCJBP Laennec Injection contains a variety of cytokines derived from human placenta, amino~     acids, peptides, nucleobases, and carbohydrates. This product is approved for improving liver~     function. Also, it has been prescribed for lots of diseases such as menopausal disorders,~     atopic dermatitis, skin cares as well as fatigue for long time. Although its action mechanism~     and clinical effectiveness are not still clear, there are reports which say a strong~     probability of its clinical effectiveness in the chronic fatigue patients.~      This study aims to investigate the safety and efficacy of GCJBP Laennec Inj. (Human placenta~     hydrolysate) in the chronic fatigue patients through a randomized controlled tial.~   "
139440|NCT01742169|"~     The United States Preventive Services Task Force (USPSTF) recommends colorectal cancer (CRC)~     screening using fecal occult blood test (FOBT), sigmoidoscopy, or colonoscopy, beginning at~     age 50 and continuing until age 75. Despite this recommendation, rates of CRC screening~     remain inadequate and large disparities exist. Screening rates are lower among Black and~     Hispanic populations, in areas with high poverty rates, among individuals with low education,~     and for those who utilize Medicaid or lack health insurance. This study will determine the~     effectiveness of a multifaceted intervention to increase the number of patients who have~     never been screened for CRC and are cared for at a community health center (CHC) that~     complete a fecal immunochemical test (FIT) within 6 months of randomization to an~     intervention group compared to patients in a usual care group. We believe that the proposed~     intervention will improve the CRC screening rate in a cost-effective and sustainable way,~     ultimately leading to a reduction in the high rate of CRC.~      Aim 1: To conduct a randomized controlled trial to determine if a multifaceted intervention~     increases the proportion of patients who complete a FOBT within 6-months of randomization.~      Hypothesis 1: Compared to usual care, the intervention will increase the proportion of~     never-screened patients who complete FOBT within 6 months of randomization.~      Aim 2: Assess the costs of the intervention and the costs per additional initial screening~     compared to patients who receive usual care.~   "
139441|NCT01742156|"~     Diagonal ear lobe crease and microcirculatory disorder in the conjunctiva are both non~     invasive methods documented in the literature as early signs of coronary artery disease. We~     wish to study the sensitivity and specificity of both signs by conducting a single blind~     study involving patients with documented presence or absence of coronary artery disease via~     angiogram.~   "
139442|NCT01742143|"~     The purpose of this 1 year study is to see if the ICCAN program is working, and to compare~     the ICCAN program to the standard hospital services provided in New York City hospitals, like~     meeting with a Social Worker or a Patient Navigator (a person who provides personal hospital~     guidance).~   "
139443|NCT01742130|"~     The purpose of this study is to determine whether hydration with sodium bicarbonate is more~     effective than hydration with sodium chloride to prevent contrast nephropathy in patients~     undergoing primary coronary intervention for acute ST elevation myocardial infarction.~   "
139444|NCT01742117|"~     Clopidogrel is an anti-platelet medication approved by the U.S. Federal Drug Administration~     (FDA) for use in patients who undergo Percutaneous Coronary Intervention (PCI) with coronary~     stent implantation. Anti-platelet medications work to prevent blood clots from forming. Some~     studies have suggested that patients who have a certain genetic liver enzyme abnormality~     (known as cytochrome P450 2C19 [CYP2C19] *2 or *3 allele) may have a reduced ability to~     activate clopidogrel, and therefore may have a lowered response to clopidogrel. It is thought~     that perhaps people who have a coronary stent procedure may have this genetic liver enzyme~     abnormality. There is a research genetic test available to determine whether or not someone~     has this genetic liver enzyme abnormality. Ticagrelor, is a newer anti-platelet drug that is~     not dependent on the CYP2C19 liver enzyme for its activation and hence in poor clopidogrel~     metabolizers, alternative drugs like Ticagrelor have been recommended for use as an~     anti-platelet agent after PCI. The purpose of this study is to determine if genetic testing~     can identify the best anti-platelet therapy, for patients who undergo a coronary stent~     placement and do not activate clopidogrel very well.~   "
139445|NCT01742104|"~     The study aims to evaluate the quality of life (QoL) of patients affected by Primary~     Open-Angle Glaucoma (POAG), using 2 QoL questionnaires:~        1. Glaucoma Symptom Scale (GSS) and~        2. National Eye Institute Visual Function Questionnaire (NEI-VFQ -25). The study will be~          conducted on patients with well known diagnosis of POAG (transversal phase) and on~          patients with first diagnosis of POAG (longitudinal phase).~   "
139446|NCT01742091|"~     The purpose of this study is to assess the safety and side effects of multiple doses of~     LY2541546 in postmenopausal women when given subcutaneously (injection just under the skin)~     and intravenously (directly into a vein). The study will also test how long it takes the~     study drug to get into the body, how long it takes the body to get rid of it, the overall~     effect of the study drug on the body, and whether antibodies to the study drug are formed.~   "
139447|NCT01742078|"~     The purpose of this study is to determine if a single dose of LY2541546 has any side effects~     on the body and to determine how long and how much LY2541546 stays in the bloodstream of the~     body.~   "
139448|NCT01742065|"~     Only an estimated 50 million US adults aged 50-75 are up-to-date on colorectal cancer (CRC)~     screening according to guidelines set by the federal government. CRC is 90% curable with~     timely detection and appropriate treatment of precancerous polyps; increased screening could~     reduce incidence by up to 50%. Groups least likely to undergo screening, those with minimal~     education, low income, low access to health care, recent immigrants or Hispanics, are the~     same people who frequently receive care at Federally Qualified Healthcare Center's (FQHCs).~     The use of fecal occult blood tests (FOBT) and fecal immunochemical tests (FIT) is~     exceedingly low in FQHCs (7-9% of patients in the past year) and far below national averages~     and target rates. Our results will provide valuable information on how to use electronic~     health record (EHR) resources to optimize guideline-based screening in FQHC clinics whose~     patient populations have disproportionately low CRC screening rates.~      This project, in conjunction with the research team, will use an advisory panel to direct the~     research activities. The advisory panel will be made up of clinicians, leaders, researchers,~     and patients. The panel and team will guide the development of materials, the outreach to~     patients, and the research protocol to best reach FQHC patients who are due for colorectal~     cancer screening.~      This project will be conducted in two phases, Phase I is conducting a pilot at two FQHC's,~     and Phase II is rolling out the intervention to between 20-30 clinics.~   "
139449|NCT01742052|"~     The primary objectives of the study are:~        -  To evaluate the effects of three oral doses of MT-1303 compared to placebo given for a~          period of 24 weeks in subjects with relapsing-remitting multiple sclerosis (RRMS) on MRI~          parameters~        -  To evaluate the safety and tolerability of three oral doses of MT-1303 compared to~          placebo given for a period of 24 weeks in subjects with RRMS.~   "
139450|NCT01742039|"~     The primary aim of this study is to determine the safest and most effective therapeutic~     strategy to decrease the incidence of postoperative atrial fibrillation following cardiac~     surgery in an era with shorter ICU and hospital length of stay. A secondary goal is to~     evaluate the length of hospital stay associated with each treatment strategy.~   "
139457|NCT01741948|"~     There have been reports in the medical literature demonstrating a link between the~     development of provoked vestibulodynia (PVD), a sexual pain disorder, and hormonal~     contraceptive (HC) use. The purpose of this pilot study is to assess the prevalence of HCs~     induced PVD among a HC naïve population, to evaluate which of the components of the HCs are~     associated with a higher risk of the development of PVD, and to evaluate which clinical and~     genetic factors predispose the patient to HCs induced PVD. Assessments will be made through~     patient questionnaires, physical examinations, and blood tests. Microarray techniques will be~     employed to characterize, on a global level, the gene expression profiles of women who~     develop PVD in comparison to those who do not develop PVD. Patients will be followed for a~     year. Results will be used to develop a larger clinical trial.~   "
139458|NCT01741935|"~     An open, single group, single center Study to confirm CTC-Actiwise™ as a means to record and~     monitor the progression of a patient's COPD.~      Chronic Obstructive Pulmonary Disease (COPD) affects growing patient groups. Current~     knowledge about the disease limits the investigators ability to cure or interfere with the~     progression of the disease. COPD is often characterized by exacerbating infections requiring~     emergency care.~      The project aims to examine whether disease progression of COPD can be better controlled by~     continuously monitoring the patient's physical activity, along with the assessment of~     pulmonary symptoms and lung function. A key question is: can investigators find indicators~     that provides support for early intervention before severe symptoms arise.~      The patient carries a smartphone that records physical activity real-time, daily lung~     function measures, lung disease related symptoms, and use of medication.~      The experimental phase, the first part of the project, covers 25 COPD patients followed up to~     12 weeks where the primary objective is to examine and verify both new investigational~     methodology and technology.~   "
139459|NCT01741922|"~     The goal is to investigate in patients with high blood pressure, BP, namely, those with~     systolic blood pressure and diastolic blood pressure, SBP/DBP higher than or equal to 140/90~     mmHg, and high cardiovascular risk, under treatment with low-dose acetylsalicylic acid, ASA,~     whether changing the time they take the drug (same dose) to bedtime (from taking it at some~     point during the active part of the day) produces a drop in their blood pressure (mean~     systolic and diastolic over 24 hours) of at least 2.5 mm Hg; and also whether among~     non-dippers, under secondary treatment with low-dose ASA, there is be a greater decrease in~     their night BP when the drug is taken in the evening.~   "
139460|NCT01741909|"~     Intravenous Azythromycin therapy is considerably more expensive than oral therapy. The~     investigators believe that intravenous therapy is prolonged more that necessary and that oral~     therapy can be used much earlier in the course of the disease. The investigators plan to~     check if that statement is true and intervene in order to shorten the intravenous therapy.~   "
139461|NCT01741896|"~     Computated tomography (CT) is an invaluable medical resource for both physicians and~     surgeons. Contrast media are an aid to improve the diagnostic yield of CT. While an~     incredibly powerful means of imaging the human body, there are possible complications to the~     use of contrast including a hypersensitive response and contract induced nephropathy (CIN).~     The latter will typically occur 48-72 hours after administration.~      One recent meta - analysis of serum creatinine levels following contrast enhanced CT found~     6.4% of those undergoing this investigation developed CIN. Although typically transient, 1 %~     had a persisting reduced renal function, with a small minority needing renal replacement~     therapy (RRT). The development of CIN was influenced by co morbidities and by the amount of~     contrast given.~      The mechanism of injury to the kidney is not definitively established, but is thought most~     likely due to hypoxia resulting from reduced blood flow, thereby giving rise to oxygen free~     radicals causing direct damage to the kidney and also direct tubular damage.~      Remote conditioning ischaemia has been hypothesized to be nephroprotective, whereby induced~     transient ischaemia at another site could buffer the impact of the contrast medium's effects.~     This was first demonstrated during cardiac angiograms, with those patients whom received~     multiple balloon inflations in the coronary arteries were found to have a lower incidence of~     CIN than those with fewer balloon inflations. Thus it could be hypothesised that any~     ischaemia temporarily induced could be nephroprotective. This can be at a point of extremity,~     rather than involving central organs, such as the arm, with ischaemia induced by the use of a~     blood pressure cuff, inflated to above systolic blood pressure levels.~      No studies have been found in the literature attempting to demonstrate this effect in~     relation to contrast CT studies. Consequently, a randomised control clinical trial of~     patients to assess the effectiveness of remote ischaemic preconditioning is proposed.~      Study Hypothesis: That performing remote ischaemic preconditioning on those undergoing CTs~     involving IV contrast is nephroprotective.~   "
139462|NCT01741883|"~     The purpose of this study is to evaluate a side effect prevention training (SEPT) that~     optimizes patients' response expectations before the start of adjuvant endocrine treatment~     (AET) to prevent nocebo side effects and enhance quality of life during longer term drug~     intake.~   "
139463|NCT01741870|"~     To examine the effectiveness of a need-based nutritional intervention strategy in improving~     the nutritional and physical functional status of nursing home elderly.~   "
139464|NCT01741857|"~     This study will explore safety and efficacy of allogeneic umbilical cord (UC) derived~     mesenchymal stem cells transplantation (MSCT) to treat patients with active and refractory~     systemic lupus erythematosus (SLE) who have been resistant to multiple standard treatments.~     The underlying hypothesis is that the active SLE condition is caused by an abnormal immune~     homeostasis that can be restored by MSCT.~   "
139465|NCT01741844|"~     The purpose of this study is to assess the safety data of etravirine in a natural clinical~     practice.~   "
139466|NCT01741831|"~     The purpose of this study is to assess the safety data of darunavir in a natural clinical~     practice.~   "
139467|NCT01741818|"~     The purpose of this study is to determine the cutoff point for IVC collapsibility index (by~     Bedside Ultrasonographic technique) for cases in hypovolemic hemorrhagic shock with CVP~     measures less than 8 cmH2o.~   "
139468|NCT01741805|"~     Asthma is a chronic illness characterized by inflammation of the airways. Severe asthma is~     defined in the literature as asthma not controlled by medication. In recent years it has~     become known that severe asthma is a variable disease and has subtypes relating to the age of~     onset, type of inflammation and allergy, obesity, etc.~      Our aim is to characterize the phenotypes of severe asthma population in our clinic and~     compare the prevalent phenotypes to the phenotypes described before.~   "
139469|NCT01741792|"~     The purpose of this study is to confirm whether the bispecific T-cell engager blinatumomab is~     effective and safe in the treatment of patients with relapsed/refractory diffuse large B-cell~     lymphoma (DLBCL).~   "
139711|NCT01738646|"~     It has been shown that bevacizumab has significant anti-tumor activity in patients with~     recurrent glioblastoma multiforme. Vorinostat has modest anti-tumor activity against~     malignant glioma and can enhance the action of both chemotherapy and anti-angiogenics.~     Patients will be treated with a combination of bevacizumab and vorinostat.~   "
139470|NCT01741779|"~     Obesity is a major risk factor for premature arterial abnormalities including high blood~     pressure and increased stiffness. Previous studies have shown that weight loss via lifestyle~     modifications is associated with a decrease in large artery (aorta) stiffness. However, along~     with decreases in fat mass, hypocaloric diet reduces muscle mass. Whole body vibration~     results in similar increases in muscle mass and strength than those observed after resistance~     exercise and is feasible for special populations such as the obese and the elderly.~      The investigators hypothesis is that weight loss via diet combined with whole body vibration~     training would additively reduce arterial stiffness and blood pressure in obese women. The~     investigators also hypothesize that the improved arterial function with weight loss would be~     associated with beneficial changes in the main mechanisms involved in BP regulation.~   "
139471|NCT01741766|"~     Hypertension is a major risk factor for cardiovascular disease. Hypertension and abdominal~     obesity are associated with dysfunction of the main mechanisms of cardiovascular regulation,~     the autonomic nervous system and the vascular endothelium. Increased sympathetic activity and~     endothelial dysfunction are associated with increased arterial stiffness, which is an~     independent risk factor for the development of hypertension and other cardiovascular~     diseases. The recommended intervention for controlling BP in pre- and stage 1- hypertensive~     individuals is lifestyle modifications such as exercise, and not drug therapy.Although~     aerobic and resistance exercise has been shown to be beneficial for the cardiovascular~     system, special populations such as the elderly and obese may have physical and/or~     musculoskeletal limitations which may limit their participation in these exercise modalities.~      Stretching is a form of exercise that is widely recommended for injury prevention. Among the~     benefits of stretching are an increased flexibility, enhanced muscular coordination, stress~     relief, improved range of motion and an improved posture. Previous studies have shown~     stretching training to increase arterial compliance and acutely increase sympathetic nerve~     activity. In addition, low flexibility levels have been found to be associated with arterial~     stiffness. Given that stretching of skeletal muscle causes an increase in sympathetic nerve~     activity; repetitive stimulation of sympathetic activity induced by habitual stretching,~     might chronically reduce resting sympathetic activity. The reduction in sympathetic activity~     might result in a decrease of arterial stiffness and blood pressure.~      The investigators hypothesis is that 8 weeks of stretching training would reduce arterial~     stiffness, blood pressure and sympathetic activity in obese women. The investigators also~     hypothesize that the improved arterial function with stretching would be associated with~     increases in flexibility levels.~   "
139472|NCT01741753|"~     This research study is a Phase I clinical trial. Phase I clinical trials test the safety of~     an investigational drug, in this case an investigational drug combined with standard drug~     therapy. Phase I studies also try to define the appropriate dose of the investigational drug~     to use for further studies. Investigational means that the drug is still being studied and~     taht research doctors are trying to find out more about it. It also means that the FDA has~     not approved the drug for use in patients, including people with your type of cancer.~      BKM120 is a drug that inhibits the ability of tumors to grow and survive, which may lead to~     better outcomes in many types of cancer.~      Abiraterone acetate is a drug that is approved for the treatment of prostate cancer, and~     works by inhibiting an enzyme found in prostate tumor tissue. While taking abiraterone~     acetate, individuals must also take a glucocorticoid such as prednisone.~      Most patients with castrate-resistant prostate cancer will receive treatment with docetaxel,~     after which treatment with the combination of abiraterone and prednisone has been shown to be~     effective. Evidence has shown an interaction between the pathways through which BKM120 and~     abiraterone act on cancer. Therefore, it is thought that the treatment of castrate-resistant~     prostate cancer will be enhanced by combining BKM120 with abiraterone plus prednisone. The~     purpose of this study is to determine a safe dose for the combination of daily oral BKM120,~     abiraterone acetate, and prednisone in patients with castrate-resistant metastatic prostate~     cancer who have received prior treatment with docetaxel.~   "
139473|NCT01741740|"~     There are only little data on the risk of chronic complaints (pain and discomfort) following~     open non-mesh sutured repairs of small umbilical or epigastric hernias. Our primary and~     secondary endpoints were long-term pain and discomfort at rest, respectively and thirdly~     recurrence. The setup was a retrospective two-centre study including patients ≥18 years~     undergoing primary elective open non-mesh sutured umbilical or epigastric hernia repairs. The~     survey included questions on suspicion of recurrence, reoperation for recurrence (if yes~     patients were examined by a consultant in patients home), pain, discomfort, work, and leisure~     activities. We analysed 295 consecutive patients through a non-validated structured~     questionnaire.~   "
139474|NCT01741727|"~     A study of ABT-414 in subjects with solid tumors.~   "
139475|NCT01741714|"~     This study will highlight and validate chiropractic spinal manipulative therapy (CSMT) for~     migraine. If the method proves to be effective, it will provide a new non-pharmacological~     treatment option for migraine. This is especially important since some migraineurs do not~     tolerate acute and/or prophylactic medicine, due to side effects or contraindications due to~     comorbidity of other diseases while others do not have effect. Thus, alternative treatment~     options are warranted. The applied methodology of the study will aim towards the highest~     possible research standards. This international study is a collaboration between Akershus~     University Hospital, University of Oslo (UiO), Norway and Macquarie University, Australia.~     The multidisciplinary professional backgrounds are physiotherapy, chiropractic and medicine.~     By increasing the methodological quality of the investigators research to a very high level,~     the investigators see the method to work as a guide to increase the quality of chiropractic~     research in the future, as previous randomized clinical trials (RCTs) of migraine used~     methodology showing room for improvement.~   "
139476|NCT01741701|"~     The purpose of this study is to determine if Oxaloacetate (OAA) is a safe and effective~     treatment for Parkinson's disease. Each subject will be asked to make 3 study visits and~     complete two safety follow-up phone calls over a 4 month period.~   "
139477|NCT01741688|"~     This observational study evaluates the use and efficacy of intravenous (IV) tocilizumab in~     routine clinical practice in participants with moderate to severe rheumatoid arthritis.~     Eligible participants initiated on tocilizumab treatment in accordance with the local label~     were followed for 6 months.~   "
139530|NCT01740999|"~     The operational and favored standard therapy for the treatment of osteoarthritis in the~     distal interphalangeal joint is the arthrodesis, in which a titanium screw is used.~     Arthrodesis shows in the most cases the complete reduction of osteoarthritis pain and low~     loss of function. But restrictions are reported in fine motor skills.~      The operation with silicone arthroplasty is similar. As an implant, a silicone joint is used,~     which has been sufficiently tested at the metacarpophalangeal joint and interphalangeal~     joint. The advantage of arthroplasty is the function obtained in the distal interphalangeal~     joint and the resulting improved fine motor skills.~   "
139531|NCT01740986|"~     Clinical Study to Evaluate the Efficacy, Dose-response and Safety of SA09012 in Bronchial~     Asthma Patients~   "
139478|NCT01741675|"~     ABSTRACT The purpose of the study is to investigate if a monetary incentive can increase the~     response rate for vulnerable children and youth in a postal survey. A secondary purpose is to~     test if monetary incentive has an effect on the content of answers in a postal survey. The~     study is a randomized controlled trial where participants will be randomly allocated to~     receive a questionnaire together with a €15 voucher for a supermarket or to only receive a~     questionnaire. Data are taken from an intervention study aiming at creating network for~     different groups of vulnerable children and youth aged 8-23 years. The questionnaire survey~     in the present study is a follow up survey of the original study which are performed 1-2½~     years after the participant have left the study. Recruitment to the original study is still~     ongoing and the investigators expect the total participation to be around 250. In the primary~     analysis the investigators will estimate the relative risk (RR) to assess whether there is a~     difference between group allocation and questionnaire response rate. The investigators will~     adjust for age in the analysis. In the secondary analyses the investigators will test whether~     scores on the five SDQ scales are different between group allocations. The investigators will~     adjust for the covariates age and gender, since the scores may depend on age and gender (4).~   "
139479|NCT01741662|"~     The objective of the LEA-PsyCog project is to assess the prevalence of psychiatric disorders~     and psychocognitive impairments in adolescents surviving childhood leukemia .~      The second objective is to explore the complex relationships between psycocognitive~     development and soiciodemodemographics data, main characteristics of leukemia, treatments,~     side-effects, quality of life and characteristics of proxyies environment.~      3. Materials and Methods The LEA study is based on the constitution of a multi-centric~     prospective cohort in 11 university hospitals: Bordeaux, Clermont-Ferrand, Grenoble, Lyon,~     Paris (Trousseau, Robert Debré, St Louis), Marseille, Montpellier, Nancy, Nice, Rennes. Are~     inclued in LEA all the children diagnosed and treated for acute leukemia since January 1980~     (incident and prevalent cases), surviving at month 24 for the AML and ALL grafted in complete~     remission and at month 48 for the ALL not grafted in first complete remission.~      The LEA Psy-Cog study rests on a sample of the LEA cohort. Are included the patients~     12-17-years-old from the PACA-Corse sub-cohort (administrative district of 4 million of~     people which corresponds to the Marseille and Nice centers). Patients from this two centers~     are the patients with the more important length of survey, allowing us to produce a not~     biaised estimation of prevalence rate. Finally, the choice of this subsample is supported by~     the proximity of the Mediterranean Center for Adolescent in Marseilles, specifically~     dedicated to the psychological follow-up of children suffering from cancer.~   "
139480|NCT01741649|"~     Many solutions are used for cleaning the skin of a patient previous to a surgery. Although~     the efficacy of clorhexidine has been proved in other surgical procedures, there is only a~     retrospective study in cesarean section (they report no benefit of one solution over the~     other). The investigators would like to evaluate the difference in surgical site infection in~     patients after cesarean section comparing preparation of the skin with clorhexidine versus~     povidone.~   "
139481|NCT01741636|"~     Survivorship Care Planning may improve overall well-being and quality of life of colorectal~     and lung cancer survivors~   "
139482|NCT01741623|"~     This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single~     dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence~     between Test Product and the corresponding Reference Product under fasting condition in~     normal, healthy, adult human subjects.~   "
139483|NCT01741610|"~     This study was conducted to evaluate the effects of rapid crystalloid (Lactated Ringer's~     solution) or colloid (hydroxyethyl starch; HES) cohydration with a second intravenous access~     line on the incidence of hypotension and ephedrine requirement during spinal anaesthesia for~     caesarean section.~   "
139484|NCT01741597|"~     This phase I trial studies the side effects of dynamic contrast enhanced magnetic resonance~     imaging (DCE-MRI) in patients with advanced breast or pancreatic cancer with metastases to~     the liver or lung. Diagnostic procedures, such as DCE-MRI, may help measure a patient's~     response to treatment~   "
139485|NCT01741584|"~     The aim of the study is to investigate whether exercise improves cognitive and motor~     functions in Parkinson's disease. To test this hypothesis, the researchers study general~     brain functions in subjects with PD during a 6-months exercise program.~   "
139486|NCT01741571|"~     Endobronchial ultrasound-guided transbronchial fine needle aspiration (EBUS-TBNA) techniques~     have not been well studied. The investigators will conduct a randomized study comparing the~     diagnostic yield and specimen quality of EBUS-FNA performed with and without suction applied.~   "
139487|NCT01741558|"~     Experimental studies suggest that anti-inflammatory and immunomodulatory drugs could reduce~     the inflammatory profile in acute ischemic disease and reduce the area of ischemia.~     Methotrexate is a drug that has shown promise in ischemic disease in animal studies.~   "
139488|NCT01741545|"~     The primary objective for this study is to evaluate the proportion of subjects who achieve~     SVR12 (HCV RNA < LLOQ (target not detected) at post-treatment follow-up Week 12 in subjects~     with Genotype(GT)-1b, -4 and GT-2, -3~   "
139489|NCT01741532|"~     A multi-center, placebo controlled, double-blind trial comparing the efficacy and safety of~     18 months of treatment with deferiprone versus placebo in patients with PKAN.~      This investigator-initiated trial is funded by the European Commission's Seventh Framework~     Programme (FP7/2007-2013, HEALTH-F2-2011, grant agreement No. 277984) to the TIRCON~     consortium (Treat Iron-Related Childhood-Onset Neurodegeneration) and by the FDA OOPD (Dr.~     Elliott Vichinsky)~   "
139490|NCT01741519|"~     The study will compare the pharmacokinetics (PK), safety and tolerability of long-term~     infusion of lyophilized landiolol (LDLL600) against esmolol (Brevibloc) by measurement of~     blood concentrations of landiolol, esmolol and their metabolites, and by monitoring systemic~     cardiovascular and local tolerability, blood pressure (BP), ECG including heart rate (HR) and~     adverse events (AEs).~   "
139491|NCT01741506|"~     The purpose of the study is:~      To estimate patients with lung cancers who will undergo surgery total haemostatic /~     thrombotic capacity pre, per-and postoperatively.~      To investigate whether prophylactic treatment with Low Molecular Weight Heparin (LMWH)~     affects the patient's potential hypercoagulability.~      To investigate whether there are differences in patients who will undergo Video Assisted~     Thorascopic Surgery (VATS) or open surgery in regards of impact of the coagulation system.~   "
139493|NCT01741480|"~     The study will begin in 2013 whereby patients having an early warning system (EWS) alert will~     be randomized to be seen by the rapid response team (RRT) for triage versus usual care. A RRT~     is usually made up of a nurse and/or a physician who respond to a requested activation of the~     RRT (called an ACT). The intervention will occur as follows:~        1. Real-time monitoring of the eight general hospital wards (GHWs)((10100, 10200,~          11100,11200, 12100, 12200, 14400, 14500)will occur 24 hours daily. Through multiple past~          collaborative efforts and studies involving interventions at BJH, informatics personnel~          have already demonstrated that they can accomplish this task using their computing and~          algorithmic resources. The prediction tool (PT) employed is a validated PT aimed at~          identifying any form of clinical deterioration occurring on a GHW requiring ICU transfer~          or leading to patient death.~        2. Patients meeting the prediction criteria for an increased risk of clinical deterioration~          will be identified on the GHWs. An automated text message will be generated that~          provides the patient's name, their room number, the date and time of the message, and~          text indicating that they meet the criteria for risk of deterioration. Messages will~          only be generated for patients assigned to the intervention group.~        3. The EWS text message will be sent to the on-call RRT nurse's phone. These are phones~          that are transferred from one RRT nurse to the other as changes of shift occur. It is~          their primary means of communicating with the hospital.~        4. The RRT nurse for the intervention patients will go into the flagged patient's room~          within 10 to 15 minutes of receiving the message and perform a clinical assessment.~          Based on the RRT nurse's assessment either no additional action need occur or he/she~          will call either the physician on duty or activate an ACT as well as apply the four~          D's, which was internally established at Barnes-Jewish Hospital (BJH) for treatment of~          patients on GHWs identified to have impending clinical deterioration. The four D's~          refer to the following: Discuss level of care, Drugs for treatment (e.g., antibiotics),~          Diagnostics (lab tests, cultures), and Damage control (e.g., use of intravenous fluids,~          oxygen).~   "
139494|NCT01741467|"~     This study will investigate whether real-time continuous glucose monitoring can be used as a~     tool for behavior change in people with pre-diabetes.~   "
139495|NCT01741454|"~     The purpose of this study is to determine whether combination therapy with Tolterodine ER and~     Tamsulosin is more effective than monotherapy with tamsulosin alone in reducing stent~     symptoms.~      The investigators hope to show that the addition of Tolterodine ER to Tamsulosin will~     provided added benefits in reducing stent symptoms in patients who have had unilateral~     placement of a ureteral stent.~      The investigators hypothesize that combination therapy with tamsulosin and tolterodine ER~     will yield greater symptom relief than tamsulosin alone.~   "
139496|NCT01741441|"~     After laparoscopic total fundoplication (LTF) 12-15% of patients have persistent reflux~     symptoms and 20-25% develop gas-related symptoms. Reflux symptoms, gas bloating and inability~     to belch occurring after surgery have been associated with mixed (acid and weakly acid) (MR)~     or weakly acidic reflux (WAR). To date, few studies have evaluated functional outcome after~     LTF in patients with MR or WAR, with the majority reporting only short-term results.~      It has been shown that delayed gastric emptying (DGE) might also be an important factor for~     abdominal distension and adverse outcome after LTF.9,10 However, the correlation between poor~     long-term outcome after LTF and DGE is controversial. In addition, the effect of DGE in~     patients with MR or WAR is poorly investigated.~   "
139497|NCT01741428|"~     Early interventions to promote physical activity, dietary lifestyle changes and optimal~     medication for cardiovascular risk factor reduction in over 3 years follow-up. A randomized~     Clinical Trial.~   "
139498|NCT01741415|"~     Despite recent advances in substance abuse interventions, a large percentage of clients~     entering residential treatment for substance use will drop out of treatment prematurely, and~     of the remaining, many will relapse soon after treatment completion. Previous research~     indicates that an individual's ability to withstand psychological distress is a key factor~     necessary to maintain drug and alcohol abstinence and to remain in substance use treatment~     without absconding. In previous work, Dr. Bornovalova developed a specific distress tolerance~     treatment called Skills for Improving Distress Intolerance (SIDI). This intervention features~     skills training in behavioral and acceptance strategies and intentional clinical exposure to~     emotional distress. SIDI was developed and piloted with a sample of urban drug users seeking~     treatment in a residential facility. Individuals receiving SIDI exhibited greater improvement~     in distress tolerance than those in two comparison groups (receiving treatment-as-usual and~     supportive counseling).~      Current study. The investigators received NIDA funding to conduct a randomized clinical trial~     with 325 clients entering a residential substance use treatment facility. Study participants~     will be randomized into two treatment groups: (1) those receiving SIDI and (2) those~     receiving Supportive Counseling (SC). Participants will receive 10 treatment sessions over a~     period of 4 months. Then, the investigators will follow clients for one year to examine~     treatment retention and abstinence.~   "
139499|NCT01741402|"~     The objective of this work was to compare the effects of two balance training programs, one~     Nintendo Wii Fit-based and the other traditionally-based without the use of a gaming system,~     on the (1) balance, (2) gait, (3) functionality and (4) cognition ability in older adults. It~     is a prospective, single blinded, randomized clinical trial performed at Center of Research~     of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo~     University. Thirty-two older adults are randomly in control and experimental group, 16 each~     one. The study includes only participants scoring at least 24 in the Mini-Mental State~     Examination to rule out effects of dementia; without the presence of depression, according to~     the Geriatric Depression Scale of Yesaváge - version 15 (GDS-15 ≤ 5) and scores on the Berg~     Balance Scale (EBB ≥ 41).~   "
139500|NCT01741389|"~     The main aim is to examine the influence of daylight and melatonin on the temporal variations~     of hemostatic factors with key roles in the hemostatic process and its regulation. Particular~     emphasis will be on exploring the role of melatonin in hemostasis by comparing subjects with~     tetraplegia with able-bodied control subjects.~   "
139501|NCT01741376|"~     The purpose of this study is to examine the role of progesterone (a hormone found in both men~     and women) on stopping cocaine use. The study will examine whether the medication, in~     combination with behavior therapy will decrease cocaine use, cigarette smoking, withdrawal~     symptoms, impulsivity and stress.~   "
139502|NCT01741363|"~     1. The abundant results from this trial will be helpful for assessing the feasibility of~          increasing stool sampling and shortening screening interval in population setting for~          lower and upper gastrointestinal tract lesions, their long-term effects, and the~          respective cost-effectiveness.~        2. The study will evaluate the value of population-based screen and treatment for H. pylori~          infection when the HPSA is combined with the FIT.~   "
139503|NCT01741350|"~     To conduct a randomized clinical trial (RCT) of a community-friendly behavioral intervention~     designed to reduce HIV risk behavior among injection drug users (IDUs) in drug treatment by~     comparing risk-behavior outcomes of four weekly intervention sessions with a~     time-and-attention-matched control condition.~   "
139505|NCT01741324|"~     Vitamin D has a range of biological effects of public health relevance. Vitamin D status is~     assessed on levels of its metabolite 25-hydroxyvitamin D [25(OH)D], where levels < 50 nmol/L~     indicate insufficiency. Despite studies indicating that the vitamin D intake among Swedish~     children are significantly below recommendations, little is known of their vitamin D status.~     The investigators have recently found inadequate vitamin D status in pre-school children~     living in northern Sweden, especially in dark-skinned children and during the winter months~     despite vitamin D intakes meeting the recommendations. Overall, 25% of the light skinned and~     40% of the dark skinned children had S-25(OH) D <50 nmol/L (Öhlund I, unpublished data). The~     aim is to examine which amount of vitamin D is needed to maintain or increase S-25(OH)D to~     ≥50 nmol/L among 97.5% of the participants regardless of skin color or geographic location~     (northern or southern Sweden). Furthermore the investigators will examine if vitamin D status~     affects on health markers as bone density, blood pressure, serum lipids, fatty acids,~     inflammatory and immunological markers and mental wellbeing.~      Children aged 5-8 years living either northern (Umeå) or southern Sweden (Malmö) will be~     recruited to this trial during November-December 2012. They will be randomized to a vitamin D~     supplement of either 10 or 25 g per day, or in Malmö also placebo to be used for three~     months. The randomization will be stratified according to skin color (light or dark)~     according to a method using visual inspection and interviews of parents/guardians. The~     investigators will use a 2×2×2 factorial design to investigate the effects of two different~     doses of vitamin D (10 µg and 25 µg) in children with dark and light skin color, living in~     northern (Umeå) and southern (Malmö), Sweden. In order to achieve a moderate difference~     between groups (effect size 0.25) 20 children per group are required (power> 87%, alpha =~     0.05). With an estimated dropout of 10%, a total of 220 children will be included.~      At baseline, the participants will undergo blood sampling for S-25(OH)D and other biomarkers,~     blood pressure and anthropometrical measurements, including bone densitometry and body~     composition using air displacement pletysmography, and the parents will answer a~     questionnaire on behavioral and emotional problems in the participating child using the Child~     Behavior Checklist. These measurements will be repeated at follow-up in February-March 2013.~   "
139506|NCT01741311|"~     This study will test whether 3H+ (Holistic Health for HIV) is comparable to the original~     HHRP+ (Holistic Health Recovery Program) in reducing HIV risk behaviors and improving ART~     (Antiretroviral Therapy) adherence in a randomized controlled comparative effectiveness trial~     among 256 HIV+ persons in drug treatment who report unsafe injection drug use practices or~     sexual risk behavior.~   "
139507|NCT01741298|"~     The metabolic syndrome is increasingly being recognized as a major threat to good health -~     especially cardiovascular health - and its frequency appears to be increasing in relation to~     the current epidemic of obesity. The objective of this study is to determine whether a~     program of enhanced lifestyle intervention can, compared to standard care, reduce the~     frequency and severity of the metabolic syndrome as assessed by clinical, metabolic,~     inflammatory and vascular outcome measures. EC will consist of a 17-session structured,~     lifestyle intervention plan, directed at achieving weight reduction and increasing physical~     activity change through education, behavior modification and stress management, and conducted~     in groups. It will comprise a 3-month Core Curriculum of 8 sessions, followed by a~     Maintenance phase with 9 monthly sessions delivered by lifestyle counselors, experienced in~     breaking through barriers in working with socioeconomically disadvantaged members of minority~     groups. All participants will have baseline, 6-monthly and 1-year assessments. This project,~     Project 2, entitled Community Health Approaches to Reducing Risk in the Metabolic Syndrome~     (CHARMS), seeks to study psychosocial and behavioral (lifestyle) variables that may~     contribute to the progression or amelioration of atherosclerotic processes underlying the~     pathogenesis of coronary heart disease (CHD).~   "
139508|NCT01741285|"~     We hypothesize that extra-fine particle treatment with HFA-QVAR will be superior in improving~     small airways dysfunction, especially in ex-smokers and smokers with asthma.~      To investigate this, we will perform a study comparing the efficacy of extra-fine particle~     HFA-QVAR 200 µg b.i.d. to an equipotent dose of course particle HFA-beclomethasone~     (HFA-Clenil) 400 µg b.i.d. and with coarse particle HFA-fluticasone (GSK) 250 µg in~     ex-smokers and smokers with asthma.~      Study design: This study will be an open-label, randomised, three-way cross-over, two-center~     study. 20 smokers and 20 ex-smokers with asthma will receive the following treatments for two~     weeks:~   "
139509|NCT01741272|"~     The primary objective of this study is to determine if early active range of motion after~     mini-open rotator cuff repair in adults results in improved shoulder range of motion at 6~     weeks and 3 months after surgery. The secondary objective of this study is to determine if~     early mobilization improves disease-specific quality of life and promotes earlier return to~     work/function.~      Hypothesis: Adults undergoing mini-open rotator cuff repair will have faster recovery of~     range of motion, improved disease specific quality of life and earlier return to~     work/function if allowed to begin early active range of motion compared to subjects who are~     immobilized in a sling for 6 weeks.~   "
139510|NCT01741259|"~     The purpose of this study is to determine if epidural meperidine administered by~     patient-controlled bolus button is equivalent to a low dose infusion plus patient-controlled~     bolus.~   "
139511|NCT01741246|"~     Investigators hypothesize that chronic primary headaches are accompanied by a discrete~     pattern of brain metabolism and activity involving brain structures related to the~     development of acute exacerbations as well as pain modulation. Such structures include the~     brainstem, hypothalamus, and orbitofrontal cortex and can be defined using functional brain~     imaging.~   "
139512|NCT01741233|"~     The overall purpose of the study is to investigate whether there is a relationship between 26~     different single nucleotide polymorphisms (SNPs) in the vitamin D pathway, ultraviolet B~     (UV-B) irradiation of the skin and vitamin D status.~      The hypothesis is that vitamin D status are influated by different genetic genotypes in the~     vitamin D pathway.~   "
139513|NCT01741220|"~     The aim of this study is to identify factors influencing work engagement and wellbeing in~     German-speaking intensive-care providers and anesthesiologists.~   "
139514|NCT01741207|"~     We designed this study to evaluate the effect of N-acetylcystein on biomarkers of platelet~     activation , cardiac necrosis and coronary reperfusion in patients undergoing percutaneous~     coronary intervention.~   "
139515|NCT01741194|"~     This study will evaluate the effects of daily dosing of AC-1204 on cognition, activities of~     daily living, resource utilization, quality of life, pharmacokinetic measures and safety~     among participants with mild to moderate Alzheimer's Disease.~   "
139563|NCT01740570|"~     The goal of Part 1 of this clinical research study is to find the highest tolerable dose of~     cabazitaxel that can be given to patients with glioblastoma. The goal of Part 2 is to learn~     if cabazitaxel can help to control glioblastoma. The safety of the study drug will also be~     studied in both parts.~      Cabazitaxel is designed to interfere with the growth of cancer cells by stopping cell~     division.~   "
139734|NCT01738347|"~     To evaluate the safety, bio-distribution, and radiation dosimetry; and to optimize the~     Imaging Protocol of GEH120714 (18F) Injection. Study recruits healthy volunteers and~     participants with relapsing and remitting multiple sclerosis.~   "
139516|NCT01741181|"~     Background and Objectives :~      The presence of vitamin D deficiency in patients with type 2 diabetes mellitus (T2DM) is~     associated with an increased risk of cardiovascular disease (CVD). We aim to see whether~     supplementation of vitamin D in these patients helps to improve the endothelial function (EF)~     a surrogate marker of CVD risk.~      Hypothesis: Vitamin D supplementation in patients with T2DM and low serum 25(OH) D~     concentrations (<30ng/ml) will improve EF as measured by the Endo-PAT machine by 0.4 units~     (30% improvement over baseline) and/or will result in a increase of EPCs (CD133+/KDR+) and~     CD45dim CD34+/KDR.~      The investigators will test this hypothesis by comparing 2 groups of T2DM patients randomized~     to placebo or vitamin D3 for 16 weeks.~      Methods:~      This is a 16 weeks trial in which 120 T2DM patients will be screened with the aim to recruit~     60 T2DM patients with vitamin D deficiency or insufficiency. Out of these 60 patients , 30~     patients will be started on vitamin D supplementation and 30 patients will be given a matched~     placebo. Endothelial function (EF) will be checked before and after supplementation to see a~     change in EF.~      Significance of Project:~      If this study shows a significant improvement of EF, it would justify larger scale studies to~     show that vitamin D supplementation in patients with T2DM mitigates CVD risk and vitamin D~     supplementation in patients with T2DM and vitamin D deficiency to improve CVD risk.~   "
139517|NCT01741168|"~     Braces have been used o treat stable (not requiring surgery) burst fractures with much~     success. Recently questions have been raised in regards to the importance of the brace. Some~     studies have results that suggest a brace is not important in having a good outcome. However,~     this has never been proven. This study is being conducted to see whether or not wearing a~     brace is important to having a good outcome.~   "
139518|NCT01741155|"~     The purpose of this study is to estimate and compare the objective response rate of SPI-1620~     administered in combination with docetaxel in patients with NSCLC and to determine the safety~     of SPI-1620 when administered in combination with docetaxel.~   "
139519|NCT01741142|"~     The purpose is to study the efficacy and safety of ABT-436 in Major Depressive Disorder.~   "
139520|NCT01741129|"~     The investigators aimed to compare the efficacy of nasal intermittent mandatory ventilation~     (IMV) and nasal continuous positive airway pressure (CPAP) in early rescue surfactant~     treatment in preterm infants.~   "
139521|NCT01741116|"~     The aim of this study is to evaluate efficacy and safety of Dovitinib(TKI258) in patients~     with castration resistant prostate cancer after failure of docetaxel-based chemotherapy.~     Further correlative study for metabolic response using PET image and change in serum~     fibroblast growth factor 23(FGF23) will be conducted.~   "
139522|NCT01741103|"~     The purpose of the study is to evaluate the effect of sitagliptin on overall blood glucose~     concentrations in Type I Diabetic subjects. The study also aims to evaluate post meal~     glucagon concentrations in Type I Diabetic subjects (a possible mechanism of reduced blood~     glucose concentrations) and indices of oxidation stress in the plasma of these subjects.~   "
139523|NCT01741090|"~     Background & Aim: Bone marrow derived mesenchymal stem cells (BM-MSCs) have capacity to~     differentiate into hepatocytes and anti-fibrotic effect in the experimental model. No study~     was done in humans with alcoholic liver cirrhosis. The researchers investigated the~     anti-fibrotic effect of BM-MSCs in alcoholic cirrhosis as Phase II clinical study.~      Methods: Eleven alcoholic cirrhosis patients (M:F = 10:1) with Child-Pugh's class B and~     maintenance of alcohol abstinence at least 2 months were enrolled. At baseline, all patients~     received liver biopsy, hepatic venous pressure gradient (HVPG) measurement and serologic~     tests. BM-MSCs were isolated from each patient's BM and amplified for one month and injected~     two times at 4, 8week through Rt. hepatic artery. 5x106cells/mL of BM-MSCs were injected in~     each session. Follow up biopsy, HVPG and relative expression of tissue transforming growth~     factor-1 (TGF-β1), α smooth muscle actin (α-SMA) and collagen-1 by real time RT PCR were~     measured after 12weeks from 2nd BM-MSC injection. The primary outcome was improvement in~     patients' histology Aim :~      The researchers aimed to evaluate safety and effectiveness of new therapy with bone marrow~     derived autologous mesenchymal stem cell for hepatic failure caused by alcoholic liver~     cirrhosis.~   "
139524|NCT01741077|"~     The purpose of this cross-sectional study was to examine whether or not physical changes or~     adaptations occur in response pregnancy or to the higher intakes of folic acid from~     supplementation typically consumed during the reproductive period.~   "
139525|NCT01741064|"~     The purpose of the study is to evaluate the long term vascular morbidity and mortality in~     kidney transplant recipients based on one year post transplant levels of intact parathyroid~     hormone.~   "
139526|NCT01741051|"~     The purpose of this study is to use an air filter intervention to evaluate the relationship~     between particulate matter air pollution exposure during pregnancy and fetal growth. We~     hypothesize that: 1) portable high efficiency air (HEPA) filters will produce major~     reductions in home indoor concentrations of particulate matter and 2) pregnant women whose~     exposures to particulate matter are reduced by this intervention will give birth to children~     with greater mean body weight for gestational age.~   "
139527|NCT01741038|"~     This is a personalized anti-cancer vaccine protocol which includes an in-situ (in the body)~     cancer vaccine step which combines killing a single metastatic tumor lesion by use of~     cryoablation in order to cause the release of tumor-specific markers to the immune system and~     then injecting bioengineered allogeneic immune cells (AlloStim) into the lesion as an~     adjuvant in order to modulate the immune response and educate the immune system to kill other~     tumor cells where ever they reside in the body.~   "
139528|NCT01741025|"~     The purpose of this study is to compare outcomes when patients with chronic sacroiliac joint~     pain undergo either SI joint fusion with the iFuse Implant System or undergo conservative~     management of the SI joint~   "
139529|NCT01741012|"~     Cervical neoplasia is increased in women with SLE most likely due to cervical infection with~     human papilloma virus (HPV). 70% of cervical cancer is caused by HPV types 16 and 18.~     Gardasil vaccine prevents cervical infection with HPV types 16 and 18. Thus lupus patients~     (who are susceptible to cervical cancer) may benefit from getting Gardasil vaccine which can~     prevent cervical cancer. Vaccines are generally safe and efficacious in SLE but no studies~     have been done on the use of this vaccine in SLE. The investigators hypothesize that Gardasil~     vaccine is safe and effective in SLE. This study will look at vaccine safety in patients with~     mild to moderate and minimally active or inactive SLE and measure how well they make~     protective antibodies after receiving the vaccine. In other words this will check how well~     the vaccine works in SLE.~   "
139532|NCT01740973|"~     Background Laparoscopic cholecystectomy is a very common procedure. Postoperative pain,~     especially around the umbilical port is dominating the first postoperative week. Single~     Incision Laparoscopic cholecystectomy (SILC) has been proposed to diminish postoperative~     incisional pain and improve cosmetic results, but results are not convincing and the risk of~     formation of an umbilical trocar-site hernia is not properly investigated.~      This study aimed to investigate the risk of umbilical trocar-site hernia formation after SILC~     vs. conventional 4-port laparoscopic cholesystectomy.~      Methods This is a cohort registry study with prospective questionnaire and clinical follow-up~     on 239 patients having a SILC from 1/1 2009 to 1/6 2011 vs. 478 mathed patients having a~     conventional laparoscopic cholecystectomy (consecutively from one month before and after~     SILC. They are matched for age, gender, date of operation, and surgeons skills (database from~     intraoperatively registered data). Primary endpoint is umbilical trocar-site hernia formation~     (operation for a umbilical hernia or clinical hernia).~      The H0 hypothesis is that there is not difference between SILC and conventional.~      Exclusion criteria are: death, operation for acute cholecystitis. The included patients will~     be sent a questionnaire asking for operation for a hernia in the area, suspicion of a hernia,~     and perioperative data that we do not have in the database. Futhermore those patients who~     suspect a hernia will be invited to aclinical exam by a medic to state the diagnosis.~     Furthermore we patients are asked to report if they have chronic pain and/or discomfort.~   "
139533|NCT01740960|"~     The results of phase I Namisol® study (Klumpers et al. Br J Clin Pharmacol, 2012), implicate~     that Namisol® may have a favorable PK and PD characteristics and is safe to use in people.~     However, the study included only young adults with a mean age of 21.4 years. In a previous~     THC study, subjects age has been associated with treatment response and tolerance of adverse~     reactions. This association was not supported by Lane et al. and Volicer et al.~      There is concern about the safety and tolerability of THC in the elderly population. This is~     because, elderly persons in general have higher risk of adverse drug reactions due to a~     combination of physiological factors such as decreasing in lean body mass, the reduction of~     renal and hepatic clearance, and medical comorbidity which can lead to polypharmacy and~     drug-drug interactions. Therefore, data from the phase I trial cannot be translated directly~     to an elderly (and likely more vulnerable) population. This makes it important to evaluate~     the safety and tolerability profiles of different Namisol® doses in the elderly. In our study~     in progress Delta-THC in Behavioral Disturbances in Dementia, the Namisol® doses of 0,75 mg~     and 1,5 mg are, until now, well tolerated by elderly subjects. These doses are, however, very~     low in comparison with the doses used in phase I study with young adults (5 mg, 6,5 mg and 8~     mg). The current study on the safety and tolerability of relatively high doses of Namisol®~     will help us in the future to provide broad advice on the therapeutic index and safety~     profile of Namisol® in the elderly population.~   "
139534|NCT01740947|"~     The primary objectives of this randomized clinical trial are to evaluate if perioperative SDD~     can reduce clinical anastomotic leakage rate and its septic consequences as well as other~     infectious complications. By reduction of septic complications long-term oncological outcome~     might simultaneously improve.~   "
139535|NCT01740934|"~     This is a multi-site, four-visit, eight-week, double-blind, randomized, vehicle-controlled,~     parallel-group study followed by an eight-week open-label extension to evaluate the safety,~     tolerability, and potential effects of Anatabloc Facial Cream. The secondary aim is to~     evaluate if Anatabloc Facial Cream improves the appearance of the skin in subjects with mild~     to moderate rosacea.~   "
139536|NCT01740921|"~     Some gut hormones, called incretins, stimulate insulin production in order to control sugar~     levels but also activate brain centres and signal to stop eating. Current administration of~     incretin-based therapies mimicking these gut hormones is by subcutaneous (just under the~     skin) injection and has been routinely available for diabetic patients for more than 4 years.~     It is an effective treatment for the lowering of blood glucose with an average weight loss of~     about 3-4kg.Recent evidence, from animal studies and limited human studies, suggests that~     incretins based treatments may also have beneficial effects on blood vessel function.~     However, it is not known whether this effect is by direct action on the blood vessel~     independent of an improvement of latent inflammation which is typically associated with~     weight loss or an anti-inflammatory effect of the incretin treatment itself. The aim of this~     study is to determine whether the incretin-based diabetes treatment with the GLP-1~     (Glucagon-like peptide 1) analogue Liraglutide (also known as Victoza), which mimics the~     actions of incretins, improves blood vessel function in individuals with type 2 diabetes. It~     will determine whether the improvement in blood vessel function is independent of the effect~     of weight loss and changes in inflammation. This by the study of vascular function before and~     after 4 months of Victoza treatment in subjects with Type 2 diabetes in comparison with 1)~     participants randomized to hypo-caloric diet to achieve a similar weight loss than with~     Victoza and 2) participants randomized to treatment with once daily aspirin. Comprehensive~     assessment of blood vessel function, body fat distribution and metabolic profile at baseline~     and at the end of the treatment phase will be combined with assessments of inflammation~     markers in blood and in fat tissue biopsies.~   "
139537|NCT01740908|"~     This is an observational research study whose purposes are to see the effects of repeated~     hyperbaric oxygen therapy treatments on the levels of stem/progenitor cells in peripheral~     circulating blood following five days of treatment, 90 minutes per day at 2.0 atmospheres~     absolute in 100% USP Grade Oxygen. Hyperbaric oxygen has a greater oxygen concentration than~     air at sea level. In this research, the concentration of oxygen will be twice the level of~     oxygen at sea level.~   "
139538|NCT01740895|"~     To assess the clinical value of iFR to characterize, without concomitant administration of~     hyperemic agents and outside a specified range of iFR values, coronary stenosis severity as~     determined with fractional flow reserve (FFR)~   "
139564|NCT01740557|"~     The goal of this clinical research study is to learn the side effects of T-cells injected~     with CXCR2 and NGFR when given in combination with chemotherapy (cyclophosphamide and~     fludarabine) and aldesleukin to patients with metastatic melanoma in an attempt to allow them~     to better localize the tumor. The safety of this combination will also be studied.~   "
139766|NCT01737918|"~     Urge urinary incontinence can be a disorder caused by destroyed pelvic structures. We~     repaired the uteri-sacral ligaments (USL) by cesa or vasa. The study evaluates if solifenacin~     can lead to continence after surgery or if also the pubo-urethral ligaments (PUL) need to be~     repaired.~   "
139539|NCT01740882|"~     Laparoscopic incisional hernia repair a variety of fixation methods has been proposed to~     ensure the correct and stable intra-abdominal placement of the mesh, in order to prevent~     recurrence, but on the other hand avoiding long-term pain and discomfort. The optimal method~     is unclear.~      In Denmark the investigators have a nationwide database that records 80% of all ventral~     hernia repairs. The investigators combine data from the Danish Hernia Database, the National~     Patient Registry, and prospective questionnaire and clinical follow-up in order to get the~     true recurrence rate (clinical and reoperation rate) and the degree of long-term discomfort.~      Purpose The purpose of this national prospective kohort study is to compare the risk of~     developing recurrence of incisional hernia after laparoscopic incisional hernia repair with~     either absorbable or non-absorbable tacks, and to investigate possible. late complaints in~     terms of pain and discomfort after the two mesh fixation devices.~      The investigators include 355 laparoscopic incisional hernia repairs with absorbable tacks~     and 726 with non-absorbable tacks. It is expected that about 300 patients will be offered~     physical examination.~      Material and Method Register-based cohort study of perioperative entry of patient data and~     prospective questionnaire follow-up and depending on the answer to any. clinical trial.~      Follow-up is done by searching the Danish Hernia Database and the National Patient Register~     (to ensure data completeness) and distribution of patient questionnaire as reoperation for~     hernia recurrence is an underestimate of the true recurrence risk.~      Statistics There will be performed frequency analyzes and Kaplan Meyer statistics on the 2~     groups supplemented with multivariate Cox regression analysis. Using non-parametric~     statistics. P <0.05 considered statistically significant.~   "
139540|NCT01740869|"~     The purpose of this study is to determine whether the plasticity of autologous intrathecal~     hematopoietic cells would improve the neurologic and the social skills of pediatric patients~     with autism spectrum disorders.~   "
139541|NCT01740856|"~     Reducing the rest time after diagnostic cardiac catheterization for three hours does not~     increase the complications concerning to the procedure, compared to the rest of five hours.~   "
139542|NCT01740843|"~     In this study the effect of tDCS intensity on motor performance and corticospinal (CS)~     excitability is evaluated. The investigators expect that a positive relationship between~     current intensity and motor performance/CS excitability.~   "
139543|NCT01740830|"~     The current study investigates the effects of tDCS in patients with multiple sclerosis (MS).~     The investigators hypothesize that anodal tDCS will increase motor performance in patients~     with MS.~   "
139544|NCT01740817|"~     The purpose of this study is to determine whether a lipid infusion can up-regulate toll-like~     receptor 4 (TLR4) signaling in human subjects~   "
139545|NCT01740804|"~     Primary endpoint To observe the dynamic changes of CTC during the process of platinum based~     chemotherapy in advanced NSCLC.~      To study the relationship between CTC count and clinical outcome of chemotherapy (ORR and~     PFS).~      Secondary endpoint To study the relationship between CTC and overall survival. To study the~     molecular feature of CTC, such as epidermal growth factor receptor (EGFR), KRAS, CD117, etc.~   "
139546|NCT01740791|"~     The goal of this study is to assess the safety, tolerability, antiviral activity and~     pharmacokinetics of GS-5816 in HCV treatment naïve subjects with genotypes 1-6.~   "
139547|NCT01740778|"~     To evaluate pain responses using the Aurora lancing device and Velvet 33g lancet compared to~     other common, commercially available lancing systems. Subjects will test the devices at a~     depth setting sufficient to provide enough blood volume to trigger the OneTouch® Ultra®Mini~     blood glucose meter using OneTouch® Ultra® blood glucose test strips from either the~     fingertip or alternate site testing.~   "
139548|NCT01740765|"~     This study will determine the impact of 24, 48 and 72 hours of over and underfeeding on~     energy expenditure as measured in the metabolic chamber at the UNC Chapel Hill Nutrition~     Research Institute (UNC NRI).~   "
139549|NCT01740752|"~     Uniting Couples in the treatment of Anorexia Nervosa (UCAN2) is a collaborative treatment~     research study between the University of North Carolina (UNC) Eating Disorders Program and~     the UNC Department of Psychology and is funded by the National Institute of Mental Health.~     The study examines two comprehensive treatments as couples face the challenges of anorexia~     nervosa (AN). The program helps patients with AN and their partners address AN symptoms and~     unique stresses that AN places on the romantic relationship.~   "
139550|NCT01740739|"~     The objective of this study is to explore the relationship between the ClearView scan results~     and a variety of cardiovascular risk indicators such as the Coronary Calcium Score,~     Framingham Risk Factors, Reynolds Risk Score, and biomarkers of inflammation. The ClearView~     device is a bio-electrographic tool that may assist medical professionals in rapid assessment~     of the systemic origin of the patient's presenting symptom(s). The ClearView is a potentially~     valuable resource that may benefit a physician's office by offering expedited differentiation~     capabilities. The subsequent results have the potential to include more data that would allow~     rapid patient diagnosis, triage, and treatment; optimized precious resource expenditure~     (nursing, physician, etc.); lower costs to facility, patient and insurance company; and~     decreased office wait time.~   "
139551|NCT01740726|"~     This study focuses on treating adolescents with depression. The study has two main purposes.~     The first is to compare a new form of therapy for depression called Behavioral Activation~     (BA) to the antidepressant medication fluoxetine. BA therapy helps depressed people get more~     involved in activities they find enjoyable, which can reduce symptoms of depression. Research~     shows that both BA and fluoxetine work to reduce depressive symptoms in adolescents. However,~     unlike previous research, this study examines how well the two treatment options work in~     comparison to each other. Participants in the study are randomized to receive treatment with~     either BA or fluoxetine for 18 weeks.~      The second aim of the study is to examine the brain functions of adolescents in both~     treatment groups. Participants undergo functional Magnetic Resonance Imaging (fMRI) scans~     before and after treatment. The data from these scans will be used to compare the brains of~     participants in the BA condition with those in the fluoxetine condition. Also, the scans may~     show possible differences between participants' brains before and after treatment. These data~     may help scientists determine the ideal form of depression treatment for different types of~     people.~   "
139565|NCT01740544|"~     Healthy subjects will undergo cathodal stimulation of the right posterior parietal Cortex~     (PPC) and assessment of neglect-like symptoms in the encircling monitor system (EMS) as well~     as in a standard clinical test (Test Battery for Attention Performance, TAP, Zimmermann &~     Fimm, 1993). The aim of this study is to investigate whether cathodal stimulation leads to~     poorer test performance.~   "
139566|NCT01740531|"~     To evaluate the efficacy and safety of S 303 treated red blood cells (RBCs) in subjects who~     require chronic transfusion support due to thalassemia major.~   "
139567|NCT01740518|"~     The purpose of this study is to compare two regimens of low volume (2L) polyethylene~     glycol(PEG)plus ascorbic acid versus standard volume (4L) PEG alone for bowel preparation in~     out-patients~   "
139552|NCT01740713|"~     Deferiprone (DFP) is the most extensively studied oral iron chelator to date. It has been~     authorised in Europe in 1999 for the treatment of iron overload in patients with~     beta-thalassaemia major when DFO is contraindicated or inadequate. Despite a wide experience~     of DFP there are limited experimental data available on DFP in children and no~     pharmacokinetic data in children under 6 years of age. On the basis of the existing data in~     adults and adolescent, in the DEEP-1 trial a pharmacokinetic bridging model was developed to~     support the dose selection in children aged less than 6 years affected by transfusion~     dependent haemoglobinopathies. The study consisted of two phases, namely an experimental~     phase, during which patients received a single dose and a modeling phase, during which PK~     data obtained after single dose in patients < 6 years of age were analysed in conjunction~     with historical PK data in adults and older children and adolescents. The model-based~     analysis of the data obtained after single dose enabled the assessment of the dosing regimen~     required for the purpose of accurate pharmacokinetic bridging. The ratio between the~     predicted systemic exposure parameters (AUC and Cmax) in the target population and reference~     group were used as basis for recommendation of the dose in the target population.~   "
139553|NCT01740700|"~     The purpose of the Zenith® p-Branch® OTS Multicenter Study is to provide an early clinical~     experience and evaluate the safety and effectiveness of the Zenith® p-Branch® in the~     treatment of pararenal or juxtarenal abdominal aortic aneurysms (AAA).~   "
139554|NCT01740687|"~     The purpose of the post approval study is to evaluate the effectiveness and safety of the~     Essure System when a NovaSure Endometrial Ablation procedure is performed following a~     successful Essure Confirmation Test.~   "
139555|NCT01740674|"~     One of the biggest challenges of conducting research where the investigators follow people~     over a long period of time is keeping the participants involved. One of way that~     investigators may be able to improve participant involvement in research is to give~     participants the opportunity to complete their questionnaires online.~      Here's how the investigators think the Internet data collection system will help to keep~     participants involved and ultimately help to answer important questions about the effects of~     nutrition during pregnancy:~        1. It will allow investigators to present complicated questionnaires in a way that doesn't~          confuse participants. For example, instead of telling participants to skip the remainder~          of a question if they answered no to the first part of the question, the ePRO system~          does the skipping for them. The result is less confusion, fewer questions to read, and~          less of the participant's time.~        2. It provides a convenient way for participants to keep track of where to find the~          questionnaire, and how much they have already completed. Participants sometimes don't~          have time to answer all of the investigator's questions in one sitting. The ePRO system~          keeps track of how much participants have already done and it's ready to keep going~          whenever the participant has time. It also avoids the common problem of losing the~          questionnaires to the household paperwork pile, or worse to the recycling bin.~        3. It provides timely reminders to participants. Study participants, and especially new~          moms, are busy and they forget to complete the questionnaires. The ePRO system can~          provide timely reminders encouraging participants to respond.~        4. It helps participants complete the questionnaires accurately. The ePRO system has an~          automatic error detection ability that will alert participants to any questions they~          missed or completed incorrectly.~      Finding ways to keep participants involved in research is something that all researchers are~     concerned about, and ultimately it's a concern for all Canadians because the results of~     research are often used to make decisions about health care and the kinds of programs that~     governments provide. Losing any participant from the study reduces the ability of policy~     makers to take the best decisions and choices about what health services to fund with limited~     dollars. What the investigators propose is a study to determine whether Internet data entry~     really will keep participants involved in a longitudinal study. Previous studies have shown~     that the internet can be a useful tool for getting people to sign up for research and at~     least one small study showed that using Internet data entry can actually save money. But no~     researchers have actually tested whether it really does a better job than paper based~     questionnaires in terms of keeping participants involved.~      In order to answer this question, the investigators will randomly assign the current Alberta~     Pregnancy Outcomes and Nutrition study participants to either continue receiving the~     paper-based questionnaire or to start receiving the web-based surveys. The investigators will~     follow participants over three assessment occasions (over a period of 18 months) and observe~     any differences between the groups in their involvement. Because the investigators are~     randomly assigning participants to the two groups, differences in involvement will tell them~     about usefulness of Internet data entry as a participant retention tool.~   "
139556|NCT01740661|"~     The purpose of this study is to determine the immediate effects of cryotherapy on the lower~     extremity biomechanics during running.~   "
139557|NCT01740648|"~     This phase I trial studies the side effects and best dose of trametinib when given together~     with fluorouracil and radiation therapy before surgery in treating patients with stage II-III~     rectal cancer. Trametinib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Drugs used in chemotherapy, such as fluorouracil, work in different~     ways to stop the growth of tumor cells, either by killing the cells or by stopping them from~     dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving trametinib~     together with fluorouracil and radiation therapy before surgery may make the tumor smaller~     and reduce the amount of normal tissue that needs to be removed~   "
139558|NCT01740635|"~     Many older adults have difficulty walking. A wheelchair can improve their participation but~     older adults typically receive little wheelchair training. Structured training programs are~     effective but rely on multiple 1:1 sessions with a skilled clinician. EPIC WheelS combines 2~     brief training sessions and a 4-week home training program delivered using a portable~     computer tablet and monitored by an expert trainer. This study investigates the feasibility~     and potential for using EPIC WheelS with older adult novice wheelchair users in Vancouver and~     Winnipeg, measuring the impact on wheelchair skill, safety and confidence compared to a~     control group receiving only cognitive training.~      Hypotheses: The investigators expect that the feasibility outcomes will be sufficiently~     robust to support conducting a subsequent multi-site RCT. The investigators also expect the~     EPIC WheelS training program will have a significant treatment effect with improvement in~     wheelchair mobility, compared to a control group.~   "
139559|NCT01740622|"~     Aim~      To evaluate the efficacy of a CCHMC Human Resources Benefits program to reduce exposure to~     injury hazards and subsequent injury-related medical claims for their children.~      Hypothesis~      H1: The investigators anticipate, based on our recently completed trial, that the~     installation of multiple, passive safety devices in the homes of children 6- to 36-month old~     children of CCHMC non-contract employees randomized to the intervention group will reduce~     childhood injuries and medical claims by 50% compared to children of CCHMC non-contract~     employees who do not receive the home safety program.~      H2: Cincinnati Children's Hospital Medical Center Employees whose children are randomized to~     the intervention will have 30% less lost work days compared to employees whose children are~     assigned control group.~   "
139560|NCT01740609|"~     The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and~     immunogenicity of single escalating doses PF-06342674.~   "
139561|NCT01740596|"~     Sunshine Heart is sponsoring a prospective, multi-center, randomized trial to assess the~     safety and efficacy of the C-Pulse® System (C-Pulse).~      The purpose of the study is to determine whether the use of the C-Pulse as a treatment for~     patients in moderate to severe heart failure (HF) has demonstrated safety and efficacy, such~     that the C-Pulse System merits Food and Drug Administration (FDA) approval to market the~     device in the United States.~   "
139562|NCT01740583|"~     The purpose of this study is to test the safety and device performance of the Mitralign~     system (MPAS) to treat functional mitral valve regurgitation.~   "
139569|NCT01740492|"~     This study aims to address both the management and evaluation of pain. The primary aim of~     this study is to determine the efficacy of low dose ketamine in adults with moderate to~     severe pain in the emergency department as compared with parenteral opioids alone. Another~     aim is to examine the safety of low dose ketamine compared to opioids alone.~      The investigators hypothesize that low dose ketamine will result in more effective pain~     control than morphine alone and will not be associated with an increase in adverse events.~   "
139570|NCT01740479|"~     To determine whether, on a background of optimal medical therapy, including ticagrelor,~     opening of all suitable narrowings or blockages found at the time of primary PCI for an acute~     heart attack is better than treating only the culprit lesion in patients with multi-vessel~     disease.~   "
139571|NCT01740466|"~     Epidemiological study about eye discomfort complaints, comorbidities and diagnosis at a~     Brazil`s ophthalmological public care service~   "
139572|NCT01740453|"~     Interscalene block with local anesthetic impairs ventilation (unilateral diaphragmatic~     dysfunction). Single injection of local anesthetic induced transitory dysfunction (< 24h).~     The investigators hypothesized that continuous interscalene block would prolonged ventilatory~     impairment~   "
139573|NCT01740440|"~     Safety and clinical performance of the BMR Face device (manufactured by Bio-Medical Research)~   "
139574|NCT01740427|"~     The study is designed to compare the clinical benefit following treatment with letrozole in~     combination with PD-0332991 versus letrozole in combination with placebo in postmenopausal~     women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti~     cancer therapies for their advanced/metastatic disease.~   "
139575|NCT01740414|"~     Opioid drugs increase glial cell activation which may be related to the abuse liability of~     opioid drugs. Data supporting this hypothesis have demonstrated that glial cell attenuators~     decrease the positive rewarding aspect of opioids in laboratory animals. Ibudilast (MN-166,~     formerly AV411) is a compound that inhibits the activation of glia. Recent preclinical~     studies demonstrate that while ibudilast increases the analgesic effects of opioids, it~     decreases the rewarding effects of such drugs. It has also been shown that ibudilast~     suppresses morphine-induced release of dopamine, a primary neurotransmitter involved in the~     rewarding and reinforcing effects of abused drugs. Additionally, we recently found that~     ibudilast decreases subjective symptoms of opioid withdrawal in opioid dependent humans~     during detoxification.~      Therefore, the primary aim of this 6-7 week inpatient study is to investigate the ability of~     MN-166 to dose-dependently alter the reinforcing, analgesic, subjective, performance, and~     physiological effects of oxycodone, a commonly abused prescription opioid.~      This study includes a 10-day morphine taper phase, followed by two study phases~     (approximately 18 days each) with daily active ibudilast and placebo administration,~     respectively. After the detoxification phase, participants are randomized to receive placebo~     or MN-166, and then be stabilized on the medication. Thereafter, participants will complete~     laboratory sessions. Subsequently, during Phase 2, participants will cross over to the other~     treatment arm, stabilize, and complete laboratory sessions.~   "
139576|NCT01740401|"~     The purpose of this study is to see whether the combination of low-dose Cyclophosphamide and~     Anti-CTLA4 (Ipilimumab) will stop tumor growth in patients with advanced skin cancer. The~     investigators expect to see an increase in response rate of the combination over Anti-CTLA-4~     alone and estimate a response rate of approximately 20 % in the proposed population.~   "
139577|NCT01740388|"~     To evaluate the clinical and microbial efficacy of besifloxacin ophthalmic suspension, 0.6%~     (Besifloxacin) administered BID for 3 days compared to vehicle in the treatment of bacterial~     conjunctivitis.~   "
139578|NCT01740375|"~     To investigate the role of esophagectomy in complete responders to preoperative~     chemoradiotherapy for squamous cell carcinoma of esophagus, patients will be randomized to~     either observation or esophagectomy after concurrent chemoradiotherapy.~   "
139579|NCT01740362|"~     A study to evaluate the pharmacokinetics of CP-690,550 in subjects with mild, moderate or~     severe renal impairment, who do not require hemodialysis, compared to healthy controls.~   "
139580|NCT01740349|"~     This prospective pilot study of 30 pediatric subjects, that are indicated for standard~     colonoscopy due to follow-up of ulcerative colitis (UC), examines the Given Diagnostic System~     and the PillCam Colon Capsule in comparison to standard colonoscopy.~      This study aims~        1. To evaluate and compare the accuracy of PillCam ™ Colon capsule endoscopy (PCCE) with~          standard colonoscopy in the evaluation of colon in pediatric ulcerative colitis.~        2. To evaluate the safety of PillCam ™ Colon capsule endoscopy (PCCE) in pediatric age.~   "
139581|NCT01740336|"~     This multicenter, randomized, single-blind, placebo-controlled, two arm study will evaluate~     the efficacy and safety of paclitaxel with GDC-0941 versus paclitaxel with placebo in~     participants with locally recurrent or metastatic breast cancer.~   "
139582|NCT01740323|"~     The main purpose of the investigation is to determine if curcumin reduces NF-kB DNA binding~     and ultimately its downstream mediator IL-6 in patients receiving XRT for their breast cancer~     after having completed chemotherapy. Patients who have received prior chemotherapy will be~     eligible, because we have found that this enriched population is at particular risk for~     exhibiting increased NF-kB DNA binding and IL-6 following XRT.~   "
139583|NCT01740310|"~     The purpose of study will be to test two vaccine education strategies to learn how they~     impact flu and pertussis (Tdap) vaccination rates and attitudes regarding vaccination during~     pregnancy after participating in the intervention. The education strategies will be based on~     the elaboration likelihood model (ELM). This model is based on experimental psychology and~     has been previously used to increase breast cancer screening rates. These education~     strategies will be delivered through routine prenatal care visits to black/African-American~     women in Atlanta.~   "
139584|NCT01740297|"~     Phase 1b of the study will evaluate the safety of talimogene laherparepvec in combination~     with ipilimumab. Phase 2 is a randomized study that will evaluate the safety and efficacy of~     talimogene laherparepvec in combination with ipilimumab versus ipilumumab alone.~   "
139767|NCT01737905|"~     This is a multi-center, randomized, double-blinded, placebo-controlled, crossover, single~     dose study in 24 pediatric patients (4-11 years old) with asthma.~      The entire study consists of (i) a Screening Visit and (ii) a Study Period with two (2) Study~     Visits. All study subjects must be properly consented, under adult supervision, and screened~     against the inclusion and exclusion criteria, at the Screening Visit.~   "
139585|NCT01740284|"~     Many grass pollen allergic subjects treated with immunotherapy tablets experience treatment~     related adverse events when initiating treatment.~      The majority are local allergic reactions within the mouth and/or throat, and most of these~     reactions are mild or moderate. It is anticipated that intake of antihistamine before~     initiation of Grazax treatment would most likely reduce the discomfort associated with~     initiation of Grazax treatment. So this trial was to investigate if administration of~     antihistamine prior to initiation of Grazax treatment results in a reduction of subjects~     reporting local allergic reactions.~   "
139586|NCT01740271|"~     Epirubicin is a common chemotherapy medication used in the treatment of breast cancer.~     However, chemotherapy dosing is calculated based on people's height and weight, which may not~     be the most accurate way. The purpose of this study is to see if epirubicin dosing based on~     people's genetic profiles is better than the usual methods.~   "
139587|NCT01740258|"~     Studies which have separately studied bevacizumab for recurrent gliomas and bevacizumab for~     newly-diagnosed glioma have shown good results and the regimens have been well-tolerated by~     patients. This study seeks to investigate the use of bevacizumab with the standard therapy~     (radiation therapy and temozolomide) in newly diagnosed patients, followed by bevacizumab and~     temozolomide with the continuation of bevacizumab following progression. Two critical~     questions remain- the role of bevacizumab maintenance and bevacizumab at the time of~     progression in a patient previously treated with bevacizumab at the time of initial~     diagnosis.~   "
139588|NCT01740245|"~     Treatments for the macroscopic or pathologic lesions caused by HPV infection can be~     classified as topical, surgical, destructive, or immunomodulatory. Post surgical treatments~     generally consist of analgesic, anti-inflammatory and topical antimicrobial agents to reduce~     the risk of local infections.~      The aim of this study is to compare the efficacy and safety of polyhexamethylene~     biguanide-based vaginal suppositories to a similar chlorhexidine-based treatment, in the post~     recovery regimen after surgical treatment of cervical lesions.~      Women who underwent to CO2 laser therapy for cervical lesions are randomly assigned to~     receive 10 days of antiseptic treatment with chlorhexidine digluconate vaginal suppositories,~     or polyhexamethylene biguanide vaginal suppositories (Monogin® / BiguanelleTM vaginal~     suppositories, Lo.Li.Pharma, Italy). A weekly follow-up check was performed for 6 weeks.~   "
139589|NCT01740232|"~     Meniscus does not always heal when sutured. The investigators will make small holes in the~     meniscus before repair to promote more bleeding. The investigators expect that will help the~     meniscus to heal better.~   "
139590|NCT01740219|"~     This research study aims to develop an organizational-level intervention to enable~     communities to adopt, adapt, implement and sustain evidence-based interventions (EBIs) to~     address cancer disparities among Latinos. The investigators partner with faith-based~     organizations, since they play a highly prominent role in Latino community life. This~     three-phase study will: (1) improve understanding of the organizational infrastructure,~     skills and resources required by Latino churches to implement EBIs for cancer control, (2)~     develop a capacity-building intervention; and (3) test the intervention's effectiveness in a~     randomized trial.~   "
139591|NCT01740206|"~     Patients on chronic stimulant therapy for the treatment of Attention deficit hyperactivity~     disorder (ADHD) who are undergoing an outpatient surgical or diagnostic procedure will be~     randomized to one of two groups: stimulant medication administered on the day of surgery or~     stimulant medication withheld on the day of surgery. The choice of anesthetic pharmacology~     will be at the discretion of the attending anesthesiologist, but the endpoint will be a~     bispectral index (BIS) between 40 and 60 to ensure adequate and similar depth of anesthesia.~     Blood pressure, heart rate and use of vasopressors or anticholinergics will be recorded and~     the incidence of hypotension, bradycardia, or administration of medications will be compared~     between the two groups.~   "
139592|NCT01740193|"~     The purpose of this research study is to find the best way to decrease pain in children right~     after surgery whom have had their hernia fixed. Right now, there are two different ways~     surgeons and anesthesia providers try to decrease pain. It is not clear if one way is better~     than the other. The method used is often chosen by which one the doctor has more experience~     using. The Investigator plans to find out if one of the methods is more effective and/or~     safer than the other method.~      The results of this study will help learn how to best control pain in children having surgery~     for hernia repair.~   "
139593|NCT01740180|"~     The primary objective of this study is to collect information about how CLIPPERS patients are~     currently being treated in France.~   "
139594|NCT01740167|"~     1. The positive outcomes reported by participants in experimental group after two weeks of~          interventions will be significantly better than before interventions.~        2. The positive outcomes reported by participants in experimental group will be~          significantly better than those in control group after two weeks of providing prevention~          model interventions.~        3. The positive outcomes reported by participants in experimental group will be~          significantly better than those in control group after six months of providing~          prevention model interventions.~   "
139595|NCT01740154|"~     The purpose of this research study is to determine how sunitinib (sunitinib malate) causes~     fatigue. Patients will be asked to complete a brief questionnaire (survey) to rate their~     levels of fatigue every two weeks while they are participating in this research study. The~     questionnaire takes approximately 10-15 minutes to complete and is 9 questions. A series of~     physical measurements for fatigue will be performed before the first dose of sunitinib and~     again (4) weeks later to see if there are any changes in physical level of fatigues~   "
139596|NCT01740141|"~     The aim of the study is to find out if the timing of brachial plexus block, before or after~     surgery, has an impact of the extent of acute postoperative surgical pain or the incidence~     and severity of long-lasting (chronic) pain after surgery.~      This is a prospective, randomized, double blind study in patients with radial fractures~     undergoing surgery with volar plate. The patients will be followed up for 6 months after~     surgery.~   "
139695|NCT01738854|"~     The laryngeal mask airway (LMA) supreme is a relatively new single-use supraglottic airway~     with modification. The parameters about airway sealing such as oropharyngeal leak pressure~     (OLP) and leakage volume are important markers of efficacy and safety when using the~     supraglottic airway. The airway sealing is related to the intracuff pressure of laryngeal~     mask airway. The aim of this study is to compare the airway sealing of the LMA supreme at~     various intracuff pressure in children.~   "
139597|NCT01740128|"~     Many people with spinal cord injury (SCI) retain at least some movement below their injury,~     but their muscles often have a 'mind of their own'. Typical exercise programs focus on~     keeping muscles strong and flexible, but don't usually focus on helping patients control~     their muscles. The investigators' exercise research study will compare two different programs~     with the specific goal of improving conscious control of patients' muscles below the injury.~     This study focuses on those with 'chronic' SCI - the injury occurred at least one year prior~     to enrolling.~      This is a single center study taking place in the Bronx, NY.~      The first phase of the study will be observational - the investigators will analyze which~     nerve connections might remain partially intact through the injury (even if the nerves aren't~     consciously controlled). Participants with all severity of SCI may participate in this first~     phase.~      The second phase of the study will involve people who retain at least slight ability to move~     their legs and the ability to move the arms against gravity. Each person will undergo two~     different exercise rehabilitation strategies: weight-supported treadmill training; and~     balance training combined with skilled arm or hand exercises.~      The investigators will compare the effects of these exercise programs on a variety of~     outcomes, including gait speed, balance, strength, and muscle activation in response to brain~     stimulation.~      The investigators hypothesize that participants with chronic SCI undergoing combined~     balance/arm/hand training will show improved outcomes when compared to traditional gait or~     balance training.~   "
139598|NCT01740115|"~     The purpose of this study is to expand and continue a cohort of HIV-infected adults to~     establish the longitudinal Boston ARCH Cohort of 250 HIV-infected men and women with current~     substance dependence or ever injection drug use that have a spectrum of alcohol use; and to~     determine the effect of alcohol consumption on changes in bone health prospectively in the~     Cohort.~   "
139599|NCT01740102|"~     Objectives: Despite utilization of available means for cardioprotection during cardiac~     surgery, myocardial injury still occurs. Further improvement of cardioprotection is therefore~     necessary. Remote ischemic preconditioning (RIPC) is an easy and non-invasive method.~     Laboratory research has shown promising results regarding myocardial survival during open~     heart surgery, but the clinical value of RIPC is still largely unknown. The investigators~     hypothesize that RIPC before coronary artery bypass grafting (CABG) reduces the incidence of~     postoperative atrial fibrillation (POAF).~   "
139600|NCT01740089|"~     The purpose of the study is to demonstrate the noninferiority of Algeron 1.5 and 2.0~     μg/kg/week in combination with ribavirin compared to PegIntron in combination with ribavirin~     in the treatment of chronic hepatitis C, and to determine therapeutic dose of Algeron.~   "
139601|NCT01740076|"~     To determine the effect of a whole soy food, dietary soy nuts, on blood pressure, lipid~     levels, inflammation and menopausal symptoms in postmenopausal women.~   "
139602|NCT01740063|"~     This protocol will seek to enroll 372 adult otherwise healthy subjects presenting with~     influenza-like illness (ILI). Subjects will enter the study based on listed~     inclusion/exclusion criteria, including a positive Rapid Antigen Test (RAT) for influenza~     virus (IFV).~      Subjects will be randomized into one of three treatment groups: a DAS181 30 mg total dose~     group (DAS181-F02 formulation), a DAS181 60 mg total dose group (DAS181-F04 formulation) or a~     placebo group.~      The modified intent to treat (mITT) analysis set will include subjects with confirmed~     influenza as documented by qPCR or TCID50. The full analysis set will be used for activity~     analysis and will include all randomized subjects with baseline and treatment data. Per~     protocol, the safety analysis sets are described below in statistical methods.~      A subpopulation of 60 participants will also have additional PK and Immunogenicity blood~     samples collected. For this subgroup, PK and Immunogenicity samples will be collected at all~     study visits.~   "
139603|NCT01740050|"~     While exposure to an obesogenic environment has increased for almost every individual in~     western society, not everyone is equally susceptible to overeating and not everyone becomes~     obese. Teasing apart the physiological underpinnings of those individual seemingly~     protective- differences may contribute to the development of successful preventive measures~     and treatment. Neuroimaging studies started to deliver important insights into the~     neuroanatomical determination of individual eating behavior. However, food intake is not only~     determined by the brain, but is orchestrated by an interaction of peripheral hormones with~     neural circuits and decision-making processes. This interactive axis is also referred to as~     the gut-brain axis. While individual aspects of the axis have been studied extensively,~     detailed insight in the interaction of gut and brain in the regulation of food intake is~     lacking.~      Objective: The current study aims to investigate the effect of a) caloric restriction (very~     low calorie diet (VLCD)); b) caloric restriction with mechanical restriction (Laparoscopic~     adjustable gastric banding (LAGB)); and c) caloric restriction with mechanical restriction~     and physiological changes through malapsorption (Roux- en- Y bypass (RYGB) surgery) on~     gut-brain interactions to find an optimal balance for weight loss and long-term sustained~     weight maintenance.~   "
139604|NCT01740037|"~     Rationale: The treatment of patients with atrial fibrillation is often inadequate due to poor~     guideline adherence. An integrated chronic care program (ICCP) at a specialized AF-clinic was~     found to be superior to usual care provided by a cardiologist in terms of cardiovascular~     hospitalizations and cardiovascular mortality.~      Hypothesis: treatment at a specialized AF clinic is superior to usual care in terms of~     cardiovascular mortality and cardiovascular hospitalizations, cost-effectiveness, quality of~     life and guideline adherence.~      Objectives: primary objective is to show that an ICCP reduces cardiovascular hospitalizations~     and mortality. The secondary objectives include cost-effectiveness, guideline adherence,~     quality of life, patient knowledge and patient compliance in medication.~      Study design: randomized controlled trial with two study arms: usual care provided by~     cardiologists (control) versus integrated chronic care program at a specialized AF clinic~     (intervention) in 8 hospitals in the Netherlands. The RACE4 is an event driven study. A total~     number of 246 events is needed. In total 1716 patients with newly diagnosed AF will be~     included. Total duration of the study is 6 years with a minimal follow up of 1 year and~     maximum of 6 years. Data collected at inclusion, after 3, 6, 12 months and every year~     thereafter.~      Study population: Patients older than 18 year with newly diagnosed AF.~      Intervention: treatment through an ICCP at specialized AF clinics, consisting of a nurse~     specialist, cardiologist-supervisor and a guidelines-based information-communication~     technology (ICT) decision support program and a web-based patient centered medication~     management tool and tailored telemonitoring.~   "
139606|NCT01740011|"~     The primary objective of the present trial is to investigate, the mean operative time and to~     study the frequency and intensity of postoperative shoulder tip pain in patients undergoing~     laparoscopic surgery, i.e. cholecystectomy, colorectal surgery, hernia repair with AirSeal®~     compared with standard pressure CO2 insufflation systems. The primary hypothesis is that~     patients operated with AirSeal® have a shorter mean operative time and decreased frequency~     and intensity of postoperative shoulder tip pain compared with patients undergoing surgery~     with standard pressure CO2 insufflation systems.~      It is the secondary objective of the trial to evaluate immunologic and anaesthesiological~     aspects of laparoscopic cholecystectomy, colorectal surgery and laparoscopic hernia repair by~     observing the immune responses and volume of mechanical ventilation of the two groups through~     measuring various immunologic factors and ventilation volume/CO2 elimination volume. Surgical~     side effects will also be measured as secondary objective.~   "
139607|NCT01739998|"~     Examine the effects and safety of functional oil (olive oil with omega 3 fatty acids from~     fish oil) on different inflammatory markers in obese subjects with dietary intervention for~     weight lost.~   "
139608|NCT01739985|"~     The purpose of this study is to evaluate the benefit of addition of droperidol to prophylaxis~     with ondansetron and dexamethasone in children with high risk of postoperative vomiting~     (POV). In adults some authors showed that the effectiveness of prophylaxis is correlated to~     the number of molecules or specific procedures used.~   "
139609|NCT01739972|"~     Our hypothesis is that hypothyroid patients on DTE may have a decrease in symptoms, an~     improvement of cognitive function, and an increase in sense of well-being/ quality of life~     equivalently compared with L-T4.~   "
139610|NCT01739959|"~     The investigators examined the hypothesis that serum lactate is raised in early necrotizing~     fasciitis to a much greater extent than in other differential diagnoses, such as severe~     cellulitis, and therefore provides a diagnostic indicator.~   "
139611|NCT01739946|"~     The goal of this study is to compare protein markers in the urine of patients with and~     without overactive bladder (OAB) and InterStim®.~   "
139612|NCT01739933|"~     Ventilated ICU patients frequently have sepsis and the majority have delirium, a form of~     brain dysfunction that is an independent predictor of increased risk of dying, length of~     stay, costs, and prolonged cognitive impairment in survivors. Universally prescribed sedative~     medications—the GABA-ergic benzodiazepines—worsen this brain organ dysfunction. The available~     alternative sedation regimens, the shorter acting GABA-ergic propofol, and the alpha2~     agonist, dexmedetomidine, have both been shown to be superior to benzodiazepines, and yet are~     different with regard to their effects on innate immunity, bacterial clearance, apoptosis,~     cognition and delirium. The MENDS II study will compare propofol and dexmedetomidine, and~     determine the best sedative medication to reduce delirium and improve survival and long-term~     brain function in our most vulnerable patients— the ventilated septic patient.~   "
139613|NCT01739920|"~     The present study intends to assess the efficacy of 3 drops of 5% povidone-iodine (PVPI)~     eyedrops in reducing the bacterial flora in a conjunctival sac fundus compared to the~     standard procedure consisting of the application of 1 PVPI eyedrop 2 min before any~     intraocular surgical procedure.~   "
139614|NCT01739907|"~     Iron deficiency and vitamin D deficiencies are common in menstruating women. The present~     assay studied the influence of the consumption of a flavoured skimmed milk with iron (iron~     pyrophosphate) or with iron and vitamin D3 in iron deficient women on:~        -  Iron metabolism~        -  Biomarkers of bone remodelling~        -  Cardiovascular risk indexes~   "
139615|NCT01739894|"~     This is a single arm phase 2 trial evaluating the efficacy and tolerability of~     intraperitoneal paclitaxel with oxaliplatin and capecitabine in advanced gastric cancer~     patients with peritoneal metastasis and/or cancer cells on peritoneal cytology. Twenty~     patients will be recruited into the study for an estimated period of two years. Paclitaxel~     will be administered intraperitoneally at 40mg/m2 on Day 1 and 8 in patients receiving~     standard intravenous oxaliplatin 130mg/m2 on Day 1 and capecitabine 1000mg/m2 on day 1-14.~     The study hypothesizes that the addition of intraperitoneal paclitaxel with chemotherapy will~     improve treatment efficacy.~   "
139616|NCT01739881|"~     The study aims to determine if there are defining EBUS and confocal endoscopy features as~     well as exhaled alveolar gas VOC that can discriminate malignant pulmonary nodules or masses~     from benign etiology, thereby obviating unnecessary thoracotomy. Directly sampled alveolar~     gas VOC from patients with lung cancer will be compared against exhaled breath VOC for~     signature compounds that may complement CT in screening the population at risk.~   "
139617|NCT01739868|"~     The main objective of the study is to understand the pathophysiological mechanisms involved~     in switching from pre-diabetes to type 2 diabetes and to identify new biomarkers of type 2~     diabetes risk in the population of patients with pre-diabetes.~   "
139618|NCT01739855|"~     Bariatric surgery leads to rapid weight loss in female and male patients. Less data are~     available about its impact on bone metabolism.~      The aim of this study is the investigation of changes in bone mineral density,bone~     histomorphometric changes, serum bone turnover markers and changes in body fat and muscle~     composition in patients after laparoscopic gastric bypass surgery.~   "
139619|NCT01739842|"~     This study is designed to test whether treatment with kudzu extract will increase the rate at~     which alcohol enters the brain as measured by rapid proton magnetic resonance spectroscopy~     (1H-MRS).~   "
139620|NCT01739829|"~     The purpose of this study is to establish the safety and efficacy of xenotransplantation of~     DIABECELL® in patients with established type 1 diabetes mellitus~   "
139621|NCT01739816|"~     Since October 2010, Swiss community pharmacies can offer a 'Polymedication Check' (PMC) to~     patients on ≥4 prescribed drugs taken over ≥3 months.~      Aims:~      To evaluate first experiences shortly after implementation, missed pharmaceutical care issues~     and barriers to implementation on pharmacist's level as well as patient's acceptance through~     qualitative and descriptive studies To evaluate the impact of PMC in Swiss primary Care and~     to evaluate economic, clinical and humanistic outcomes in a subsequent randomized controlled~     trial.~   "
139696|NCT01738841|"~     This study will collect data on the safety of the MMRV vaccine (Priorix-Tetra™) used in~     routine practice in children aged 12 months to 12 years living in the Philippines.~   "
139622|NCT01739803|"~     There is a critical gap in the knowledge on how to implement effective interventions for~     renal transplant recipients (RTRs) to improve immunosuppressant therapy (IST) adherence and~     clinical outcomes. The objectives of this project were to address this gap through: (1)~     designing, implementing, and evaluating a patient-specific behavioral contract intervention~     to improve RTRs' IST adherence rates (contracts are written, signed agreements between the~     RTR and healthcare provider in which the RTR agrees to be adherent to IST according to~     mutually agreed upon criteria); and (2) measuring the effects of IST adherence on RTRs'~     health-related quality of life (HQoL) and healthcare utilizations and costs. The primary~     hypothesis was that at one year post trial enrollment, RTRs who establish behavioral~     contracts with healthcare professionals will be more adherent than those who do not establish~     behavioral contracts and subsequently will have greater HQoL and lower healthcare~     utilizations and costs. Once it is better understood how to implement effective IST adherence~     intervention programs, clinicians will have a valuable tool to promote therapeutic success,~     improve HQoL, and reduce healthcare utilizations and costs. Therefore, we pursued the~     following Specific Aims: (1) determine the effectiveness of an IST adherence contract-based~     intervention on IST adherence; (2) determine the relationship between IST adherence, the~     intervention, and RTRs' HQoL; and (3) determine the influence of IST adherence and the~     intervention on RTRs' healthcare utilizations/costs. To achieve the Specific Aims, a~     randomized controlled trial of the patient-specific behavioral contract-based intervention~     was conducted, and data regarding adherence, HQoL, and healthcare utilizations/costs were~     collected over a 12-month period for each RTR study participant and analyzed. This project~     will promote healthy lives, increase well-being, and reduce burden of illness and disparity~     among adult RTRs by providing data regarding an adherence intervention and the impact of IST~     adherence and the behavioral contract intervention on RTRs' health and economic outcomes and~     HQoL. Collectively, this new knowledge will provide critical steps toward optimizing RTRs'~     graft maintenance, productivity, and HQoL, while decreasing graft rejection, return to~     dialysis, morbidity, mortality, and healthcare costs.~   "
139623|NCT01739790|"~     N-acetylcysteine (NAC) is described as having mucolytic and antioxidant properties. It is~     widely prescribed for patients with chronic obstructive lung disease (COPD), particularly for~     those who have accompanying symptoms of chronic cough and sputum production. Compared to~     placebo, high-dose NAC will improve Saint George Respiratory Questionnaire scores in patients~     with COPD and chronic bronchitis.~   "
139624|NCT01739777|"~     The purpose of this study is to determine the safety and clinical effectiveness of umbilical~     cord mesenchymal cells transplanted by intravenous infusion in patients with heart failure.~   "
139625|NCT01739764|"~     This open-label, multicenter, non-randomized study will provide continued access to~     vemurafenib for eligible participants with BRAF V600 mutation-positive malignancy, who were~     previously enrolled and treated in an antecedent vemurafenib protocol and did not meet the~     protocol's criteria for disease progression, or are treated beyond progression and are still~     deriving clinical benefit (as assessed by investigator), and may therefore potentially~     benefit from continued treatment with vemurafenib. Participants will receive treatment with~     oral vemurafenib at 960 milligrams (mg) twice daily (BID), 720 mg BID, or 480 mg BID,~     depending on the last dose in the antecedent protocol. Treatment will continue until~     progression of disease or as long as the participant is deriving clinical benefit, as judged~     by the investigator (case-by-case decision with approval of the Medical Monitor), death,~     withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the Sponsor~     to terminate the study, whichever occurs first.~   "
139626|NCT01739751|"~     Physical activity is reduced in COPD affecting morbidity and mortality and the usual advice~     is not good enough to increase the physical activity level. The aim of the study is to~     determine the effects of pedometers in the physical level in COPD patients.~   "
139627|NCT01739738|"~     The purpose of the study is to investigate the impact of ureteral stents on the functioning~     of ureteral peristalsis (normal contractions in the ureteral organ muscle).~   "
139628|NCT01739725|"~     The Boston Scientific Helical Stent is a unique stent designed to improve flexibility and~     comfort. It is designed to conform more to the shape of the ureter (hollow tube connecting~     the kidney and the bladder) to ultimately improve patient comfort and decrease the need for~     painkillers.~   "
139629|NCT01739712|"~     Sleep intervention for youth with diabetes~   "
139630|NCT01739699|"~     This is a prospective randomized double blinded trial study involving 128 patients undergoing~     any craniotomy procedure at Evanston Hospital. The patients will be randomized by the sealed~     envelope technique. The anesthesiologist and nurses who will be administering the placebo or~     intravenous acetaminophen will be blinded to the group in which patients are assigned.~      The following general perioperative data will be recorded: patient information/preoperative~     data, procedural information, postoperative information, and overall satisfaction of pain~     management at 24 hours after surgery.~      Based on a pilot study (N-20) we expect that 25% of the placebo treated patients will require~     no opioids in the first 24 hour postoperative period. With the use of intravenous~     acetaminophen, it is hypothesized that the number of patients that do not require opioids in~     the first 24 hours after surgery will double.~   "
139631|NCT01739686|"~     Chronic heart failure is an important public health problem as it is a leading cause of~     disability, hospitalization, death, and costs. People who live with advanced chronic heart~     failure suffer from numerous symptoms that affect their daily lives. The investigators are~     conducting a randomized clinical trial to evaluate a symptom management and psychosocial care~     intervention to improve health status (symptom burden, functioning, and quality of life). The~     results will be directly relevant to patients and families who suffer with this illness, as~     well as to providers, payers, and other researchers.~   "
139632|NCT01739673|"~     This study is to evaluate the efficacy of ultraviolet-A (UVA) and riboflavin application~     (also often referred to as corneal collagen crosslinking) as a method to enhance treatment of~     infectious keratitis.~   "
139633|NCT01739660|"~     This is a Phase 1 single dose study conducted to evaluate the PK and PD of pegloticase~     administered to hemodialysis patients.~      A single dose of pegloticase will be administered intravenously to male or female~     hemodialysis patients (N = 12) starting 3 hour prior to dialysis.~      The study consists of a Screening Period, a Treatment Period, and Follow up Period.~   "
139634|NCT01739647|"~     This is a single dose study in healthy male and female (of non-child bearing potential)~     volunteers, to assess the safety, effects on the body, and blood and urine drug levels of~     AZD3293. AZD3293 is being developed for the treatment of Alzheimer's Disease~   "
139650|NCT01739439|"~     This phase I trial studies the side effects and best dose of radiosurgery boost following~     chemoradiation in treating patients with locally advanced pancreatic cancer that may or may~     not be removed by surgery. Drugs used in chemotherapy work in different ways to stop the~     growth of tumor cells, either by killing the cells or by stopping them from dividing.~     Radiation therapy uses high-energy x-rays to kill tumor cells. Radiosurgery can send x-rays~     directly to the tumor and cause less damage to normal tissue. Giving chemotherapy and~     radiation therapy together with radiosurgery may kill more tumor cells and allow doctors to~     save the part of the body where the cancer started~   "
139635|NCT01739634|"~     Diarrhea in patients with MTC (Medullary Thyroid Cancer) can be debilitating and, in some~     cases life threatening. Findings in such patients include volume depletion, renal~     insufficiency, and electrolyte disorders. Diarrhea can also lead to increased cost of care,~     reduced quality of life, and treatment delays. Not all patients benefit from conventional~     anti-diarrheal therapy. CASAD is proven to reduce diarrhea in humans and animals. Clays have~     water-binding effects, increase the absorptive capacity of the intestinal mucosa, and absorb~     the excess cytokines which are possible mechanisms of diarrhea in MTC. In this study, we will~     investigate if starting 1 g CASAD three times a day will ameliorate the severity of diarrhea~     in patients with MTC. Diarrhea in patients with MTC can be debilitating and, in some cases~     life threatening. Findings in such patients include volume depletion, renal insufficiency,~     and electrolyte disorders. We hypothesize that adding CASAD 3 grams/day will reduce the~     incidence and ameliorate the severity of diarrhea in patients with MTC.~   "
139636|NCT01739621|"~     To further determine the safety and efficacy of Proellex in premenopausal women with uterine~     fibroids who have previously completed study ZPV-200.~   "
139637|NCT01739608|"~     The objectives of this multicenter, randomized trial is to assess the participation rate~     achievable through two different screening strategies (Computed Tomographic Colonography-CTC~     and sigmoidoscopy-FS), to compare detection rate of colorectal cancer (CRC) and advanced~     adenoma of tests and to evaluate their costs. The role of Computer-aided detection (CAD) for~     CTC screening will be also assessed. The trial involves 10 Italian centers located in the~     Piedmont Region and in Verona. Residents aged 58-60 years in those districts are target for~     recruitment. Exclusion criteria include: previous diagnosis of cancer or adenoma; family~     history or hereditary syndromes; personal history of inflammatory bowel disease; patients~     screened by colonoscopy or FOBT within 2 years; severe disease.~   "
139638|NCT01739595|"~     The purpose of ZA-302 is to determine the effects of Androxal on morning testosterone and~     reproductive status in younger overweight men with acquired hypogonadotropic hypogonadism~     (confirmed morning T<300 ng/dL) and normal sperm concentration, compared to changes with~     placebo. Subjects must not have previously been treated with testosterone products within the~     last 6 months.~   "
139639|NCT01739582|"~     To determine the safety profile of Androxal in men with secondary hypogonadism.~   "
139640|NCT01739569|"~     The aim of this study is to investigate the impact of increased availability of healthy food~     and drink during working hours on reaction time and well-being in physicians and nursing~     staff.~      Hospital medical staff often works long and hectic hours, without adequate meal or rest~     breaks in order to provide 24-hour care. This is a concern, as not only the staff's~     well-being is important to the individual welfare, but it is also vital to the quality and~     safety of the care their patients receive. The investigators believe that by focusing on~     physicians and nursing staffs nutrition the investigators will see a positive effect on staff~     performance and well-being - and thus ultimately possibly on patient safety.~      Hypothesis: The provision of healthy lunch and snack meal during working hours for a period~     of 4 weeks will improve reaction time and well-being compared to habitual diet in physicians,~     nurses and nursing assistants.~   "
139641|NCT01739556|"~     Adequate platelet inhibition with dual antiplatelet therapy is a key therapeutic goal after~     primary percutaneous coronary intervention (PPCI), aimed at protecting against stent~     thrombosis and increased mortality. Recent aggregometric assays have shown that up to one~     third of acute coronary syndrome patients treated with clopidogrel have incomplete inhibition~     of adenosine diphosphate(ADP)-induced platelet aggregation while the number of patients~     treated with aspirin who have incomplete inhibition of thromboxane A2-induced platelet~     aggregation (ASPI)is much lower. High on-treatment platelet reactivity (HTPR) has been~     associated with an increased rate of ischemic events after PCI. However, recent large trials~     did not show a clinical benefit of TPR-guided therapy modification in acute coronary syndrome~     patients treated by PCI.~      On-treatment PLAtelet reactivity-guided Therapy modification FOR ST-segment elevation~     Myocardial infarction (PLATFORM) is an investigator-initiated, prospective, randomized,~     parallel-group, controlled clinical trial designed to test the hypothesis that antiplatelet~     therapy modification is superior to standard antiplatelet regimen among intermediate to~     high-risk STEMI patients undergoing PPCI. The safety hypothesis is that compared with control~     arm, interventional study arm will have similar rates of non-coronary artery bypass graft~     surgery-related bleeding. Approximately 632 ST-elevation myocardial infarction (STEMI)~     patients with intermediate to high-risk (RISK-PCI score >3) clinical features undergoing PPCI~     will be randomly allocated to treatment modification or standard treatment. Low responders to~     aspirin will receive 200 mg aspirin for 30 days. Low responders to clopidogrel will receive~     180 mg ticagrelor for 1 year. Patients will be followed up to 1 year after PPCI.~   "
139642|NCT01739543|"~     A REDUCTION IN C-SECTION RATES USING THE HEM-AVERT® PERIANAL STABILIZER.~   "
139643|NCT01739530|"~     Allogenic differentiated adipocytes (ANT-adip-AL) is produced by well-established techniques~     including cell harvesting from lipoaspirates obtained from healthy donors, expansion of~     adipose tissue derived stem cells, and differentiation into pure and immature adipocytes.~     This was an open-label study. Subjects were received subcutaneous injection of ANT-adip-AL~     and followed for 8 weeks according to the clinical trial protocol.~   "
139644|NCT01739517|"~     This pilot study seeks to demonstrate the efficacy of an intravenous lipid preparation high~     in omega-3 fatty acids (Omegaven) in the treatment of cholestasis in parenteral nutrition~     dependent patients with short gut syndrome.~   "
139645|NCT01739504|"~     This will be an open-label, non-randomized, multi-center, patient sponsored study of~     Adipose-Derived Stromal Vascular Fraction (AD-SVF) implantation performed intra-articularly~     to affected joints.~      The intent of this clinical study is to answer the questions: 1) Is the proposed treatment~     safe and 2) Is treatment effective in improving the disease pathology of patients with~     diagnosed Osteoarthritis.~   "
139646|NCT01739491|"~     The purpose of this study is to assess safety and effectiveness of extended bendamustine in~     the treatment of chronic lymphocytic leukemia (CLL).~   "
139647|NCT01739478|"~     The aim of this study is to compare the effect of packing and non-packing on the healing rate~     of perianal abscess cavities. Secondary objectives are to assess quality of life, cost~     effectiveness and rate of abscess recurrence and fistula-in-ano formation. If there is no~     difference in time to healing and non-packing is shown to be safe, acceptable to the patient~     and cost effective, this approach may become more widely accepted.~   "
139652|NCT01739413|"~     Epidural anesthesia has been found to manipulate the hyperglycemic response to surgery. It is~     unclear, however, whether the preoperative metabolic status of the surgical patient plays a~     role in the degree of this hyperglycemic response. For instance, the presence of low insulin~     sensitivity before surgery could predispose the individual to an altered metabolic response~     after surgery. In this case, it would be appropriate to identify adequate interventions that~     attenuate the response to surgical stress and facilitate the recovery process.~      The aims of this research projects are the following:~        1. To determine the extent in which epidural local anesthetics, initiated before surgery~          and continued after surgery, improves insulin secretion in patients with preoperative~          low insulin sensitivity.~        2. To understand which measures of postoperative recovery are sensitive to the restoration~          of insulin secretion in this particular group of patients~   "
139653|NCT01739400|"~     Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used~     for treatment of Eisenmenger syndrome.~   "
139654|NCT01739387|"~     This study will compare the patient handling of Flutiform® pMDI (pressurised metered dose~     inhaler) and a breath activated device (BAI). Patient handling will be assessed using~     assessment criteria which detail the correct handling steps for each inhaler.~   "
139655|NCT01739374|"~     Pelvic organ prolapse is an herniation process, needing a mesh reconstruction for long~     lasting therapeutic effect. Yet, mesh implants were reported to be related to severe adverse~     effects. This study looks at the potential benefit of mesh size reduction regarding avoiding~     operative complications.~   "
139656|NCT01739361|"~     Cell-free hemoglobin can be measured in the plasma of patients with sickle cell anemia,~     hemodialysis, after red blood cell transfusion, and in patients with sepsis. Cell-free~     hemoglobin in these patient population has been associated with poor outcomes, including an~     association with an increased risk of death. Acetaminophen may have a protective effect in~     these patient populations by inhibiting hemoprotein-mediated lipid peroxidation. The purpose~     of the present trial is to study the effect of acetaminophen on lipid peroxidation in adults~     with severe sepsis and detectable cell-free hemoglobin.~      The primary hypothesis is that systemic markers of oxidative stress and lipid peroxidation,~     as measured by F2-isoprostanes, will be significantly lower in patients with severe sepsis~     and detectable cell-free hemoglobin who receive acetaminophen compared to placebo. The~     secondary hypothesis is that patients with severe sepsis and detectable cell-free hemoglobin~     treated with acetaminophen will have better clinical outcomes, including decreased incidence~     of acute kidney injury and lower rates of hospital mortality, compared to those who receive~     placebo.~   "
139657|NCT01739348|"~     This study consists of two parts, Part I and Part II. The purpose of Part I of the study is~     to assess the efficacy and safety of verubecestat (MK-8931) compared with placebo~     administered for 78 weeks in the treatment of Alzheimer's Disease (AD). The primary study~     hypotheses for Part I are that at least one verubecestat dose is superior to placebo at 78~     weeks of treatment with respect to change from baseline in Alzheimer's Disease Assessment~     Scale Cognitive Subscale (ADAS-Cog) score and that at least one verubecestat dose is superior~     to placebo at 78 weeks of treatment with respect to change from baseline in Alzheimer's~     Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) score. The first~     approximately 400 participants entering Part I of the study are identified as the Safety~     Cohort. Participants who complete Part I of the study may choose to participate in Part II,~     which is a long term double-blind extension to assess efficacy and safety of verubecestat~     administered for up to an additional 260 weeks.~   "
139658|NCT01739335|"~     Posttraumatic stress disorder (PTSD) is a common and disabling psychiatric disorder for~     Veterans. Left untreated or under-treated, it can become a chronic condition associated with~     significant distress, depression, aggression, family disruption, substance abuse and an~     increased risk of morbidity and mortality. Considerable advances were made in the treatment~     of PTSD in recent years; however, psychopharmacological treatments have been shown to be~     largely ineffective for Veterans with PTSD.~      To address this gap, this proposal seeks to test an innovative treatment approach in PTSD -~     pharmacological manipulation of the body's major stress system (the~     hypothalamic-pituitary-adrenal (HPA) axis) with mifepristone. At high doses mifepristone is a~     glucocorticoid receptor (GR) antagonist with peripheral and central nervous system effects,~     making it a compound of interest in the treatment of stress related disorders. There is~     abundant evidence of enhanced GR sensitivity in Veterans with PTSD which is thought to~     underlie some of the symptoms of PTSD and associated disturbances in mood and cognition.~     There is also evidence that short-term mifepristone treatment has sustained beneficial~     effects on mood, cognition and sleep disturbance in some neuropsychiatric conditions (major~     depression, bipolar disorder, primary insomnia). The purpose of the study is to examine the~     effects of mifepristone to determine if it is efficacious in improving PTSD symptoms and~     associated clinical outcomes.~      To achieve these objectives, the investigators propose to conduct a Phase IIa, multi-site,~     double-blind, placebo controlled trial of mifepristone in male Veteran outpatients with~     chronic PTSD through the VA's Cooperative Clinical Trial Award program. The investigators~     propose to enroll 90 subjects at multiple VA sites based on an estimated attrition rate of~     20%. Eligible Veterans will be randomly assigned to the treatment of mifepristone (600~     mg/day) or placebo for one week and followed for up to three months. The investigators will~     also describe the effects of mifepristone on several other clinical parameters including PTSD~     symptomology, depression severity, sleep quality, and functional impairment. Several measures~     of neuroendocrine functioning will also be obtained to explore the relationship of plasma~     cortisol and adrenocorticotropic hormone (ACTH) levels to clinical response and the time to~     addition of rescue medications.~   "
139659|NCT01739322|"~     The objective of this study is to determine the biologic activity of a Platanus acerifolia~     allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house~     reference preparation (IHRP).~   "
139660|NCT01739309|"~     The purpose of this study is to estimate the disease control rate with LY2835219 for relapsed~     or refractory mantle cell lymphoma.~   "
139661|NCT01739296|"~     This is a clinical study to evaluate the efficacy of a lateral wedge insole with subtalar~     strapping in knee osteoarthritis treatment.~   "
139662|NCT01739283|"~     Investigation of Glucose-dependent Insulinotropic Polypeptide (GIP) effects at hyper and~     hypoglycemia in type 1 diabetes.~   "
139663|NCT01739270|"~     Adding dexamethasone to local anesthetic will significantly prolong duration of brachial~     plexus anesthesia and analgesia.~   "
139664|NCT01739257|"~     The effect of medical humanities on medical student bias and clinical management is unclear.~     This study characterized medical student attitudes toward obese individuals and whether~     reading a play employing empathic characters can modulate negative reactions.~   "
139665|NCT01739244|"~     The aim of this dose-finding clinical trial is to evaluate the systemic tolerability, local~     tolerability and intraocular pressure lowering effect of three different doses of SYL040012~     in subjects with ocular hypertension or open-angle glaucoma.~   "
139666|NCT01739231|"~     This is a research study about an experimental (investigational) oral ETEC vaccine (ACE527).~     ACE527 is a live attenuated vaccine that is being made to prevent disease from~     enterotoxigenic Escherichia coli (ETEC), which causes watery diarrhea, largely in children~     living in developing countries and in travelers to those countries. This research study is~     also testing an investigational adjuvant called dmLT. An adjuvant is something that is added~     to a vaccine to make it work better. The purpose of this study is two-fold. First, Part A~     aims to find out if the vaccine by itself or the vaccine combined with the adjuvant is safe,~     tolerable, and initiates an immune response. Second, Part B aims to find out if the vaccine~     by itself or the vaccine combined with teh adjuvant prevents diarrheal disease when~     challenged with ETEC H10407. About 60 healthy adults, ages 18-50, will participate in Part A,~     and they will be required to stay in the research facility for several nights for the first~     dose, but will not be required to stay overnight for the second and third doses. Participants~     will be assigned to receive either the vaccine alone, the vaccine with adjuvant, or placebo~     by mouth. Study procedures include: stool samples, blood samples, and documentation of side~     effects. Participants will be involved in study related procedures for about 8 months.~      Interested volunteers from Part A will along with volunteers who were never vaccinated in~     Part A will return to participate in Part B. These volunteers will be required to stay~     overnight in the research facility for several nights after challenge, after which they will~     be treated with antibiotics and sent home. Study procedures include stool samples, blood~     samples, and documentation of infection with ETEC H10407. If the vaccine with/without~     adjuvant is effective, the volunteers should not development diarrhea, but if the vaccine~     with/without adjuvant is not effective, the volunteers will have diarrhea for a few days.~   "
139667|NCT01739218|"~     This randomized, open-label study will evaluate the efficacy and safety of neoadjuvant~     bevacizumab in participants with initially unresectable, FIGO stage IIIC/IV ovarian, tubal,~     or peritoneal cancer. Participants will be randomized to receive 8 cycles of carboplatin plus~     paclitaxel with or without bevacizumab before surgery (interval debulking surgery [IDS]).~     Surgery will be scheduled 28 days after the last course of neoadjuvant treatment in~     participants with resectable cancer. Participants with unresectable cancer will go through~     the follow-up period. All participants will receive bevacizumab for Cycles 6 to 26.~   "
139668|NCT01739205|"~     The major objective of this project is to determine if compared to Standard Care (SC), a~     Community Approach to Lifestyle Modification for Diabetes (CALM-D) program including diet,~     exercise and coping skills training, can decrease depression, weight and HbA1c and improve~     medication adherence in low income, primarily Black and Latino/Hispanic, depressed,~     overweight, Type 2 diabetic patients seen in a large, comprehensive, community health center.~     Type 2 diabetes is a major risk factor for coronary heart disease (CHD). Obesity, poor~     glycemic control, depression, low socioeconomic status (SES) and being a member of a~     racial/ethnic minority group all increase this risk.~      The project will compare 100 CALM-D and 100 SC participants. Following 3 run-in sessions~     assessment sessions to determine eligibility, given to both SC and CALM-D participants, SC~     patients will be treated in accordance with ADA Clinical Practice Guidelines (2005) and also~     assessed by project staff at baseline, 6 months and 1 year. The CALM-D participants will~     receive 2 individual stress management and lifestyle sessions followed by 2 weekly group~     sessions. Then 4 bi-weekly sessions will be followed by 9 monthly sessions for a total of 17~     sessions. Secondary objectives of the project are to determine if compared to SC, CALM-D can~     improve glucose tolerance to challenge, insulin resistance, oxidative stress, inflammation,~     procoagulation, lipid profile, endothelial function resting blood pressure, cardiac and~     vascular function, cardiac morphology, psychosocial functioning and health quality of life.~     As many of the participants will already have been prescribed aspirin, statins, oral~     hypoglycemics and other medications, an important objective of the project will be to assess~     the extent to which improved adherence to medications - a goal of the CALM-D program - can~     account for improved intervention effects.~   "
139669|NCT01739192|"~     The research proposed in this application will determine the initial efficacy, safety and~     tolerability of a novel drug combination, bupropion and naltrexone, as a pharmacotherapy for~     cocaine dependence. A rigorous, inpatient human laboratory study will be conducted. The~     proposed study is innovative and important because it will provide the impetus for the~     conduct of double blind, placebo-controlled trials to further demonstrate the efficacy of~     bupropion-naltrexone combinations for managing cocaine dependence.~   "
139670|NCT01739179|"~     Ventriculoperitoneal shunting (VPS) was first described at the beginning of the 20th century~     as a diversionary procedure in patients with a hydrocephalus. After the introduction of~     silastic catheters in the 1970's this method became the treatment of choice for children and~     adults with communicating hydrocephalus. The average patient necessitating VPS will undergo~     at least two shunt revisions every three years, with some patients requiring more than twenty~     revisions within the first year. Therefore, any technical improvement with a positive impact~     on the revision rate not only benefits the patient through a reduction of the surgical burden~     but may also have economic advantages.~      Distal shunt failures - either due to improper placement or secondary dislocation of the~     distal catheter out of the peritoneal cavity - have been reported in 10-30% of cases.~     Catheter placement in obese patients and in patients with adhesions owing to previous~     abdominal surgery remains challenging. Most neurosurgeons will carry out a mini-laparotomy to~     allow for the placement of the distal catheter end within the peritoneal cavity, which rarely~     requires the help of a general or visceral surgeon.~      An alternative to laparotomy is the laparoscopic placement of the peritoneal catheter in VPS.~     Retrospective series have since shown the safety of this procedure and suggested an advantage~     of laparoscopic VPS in terms of operation duration, length of hospital stay and the rate of~     distal (and thus potentially overall) shunt dysfunction.~      The evidence concerning the effect of laparoscopic surgery for VPS placement is so far based~     on non-randomized studies, in which a selection bias may have influenced the outcomes.~   "
139671|NCT01739166|"~     Funded by the Ohio Department of Job and Family Services - Medicaid Technical Assistance and~     Policy Program (MEDTAPP), the Child Health Excellence Center - a University-Practice-Public~     Partnership (CHEC-UPPP) focuses on improving the health of Ohio's children in 3 target~     areas: 1) prevention of dental decay; 2) detection and management of overweight and obesity;~     and 3) lead screening. These topics represent critical public health issues for Ohio's~     children.~      The study is based on strong evidence that interventions are needed to improve practice in~     the target areas and that achieving these goals represents fundamental improvements in child~     health care that would reduce morbidity and costs. The approach for the study involves a~     trained Practice Facilitator (PF) working with multiple pediatric and family medicine~     practices to create change tailored to individual practice preferences and methods of~     operation.~      Our overall hypothesis is that a university-community consortium, utilizing evidence-based~     methods (involving education plus a facilitated, practice-tailored approach) will increase~     the rates of targeted services in primary care practices.~   "
139697|NCT01738828|"~     The GLOBAL study is an international multi-center, prospective study designed to enroll up to~     10,000 consecutive eligible subjects who are clinically referred for coronary CT angiography~     for assessment of suspected coronary artery disease (CAD).~      The purpose of the study is to perform extensive biomarker analysis of atherosclerosis in~     patients phenotyped using advanced imaging modalities of atherosclerosis.~   "
139698|NCT01738815|"~     The goal of this study is to test whether the drug valproic acid can cause changes in bladder~     tumors that might inhibit their growth.~   "
139672|NCT01739153|"~     The main objective of the current study is to examine whether a high intake of regular-fat~     cheeses (Danbo and Cheddar) affect blood lipids differently than an isocaloric intake of~     either other fatty animal food products or of starchy carbohydrates. Furthermore, effects on~     fat digestibility, blood pressure, anthropometry, bile acid metabolism and insulin~     sensitivity is investigated.~      To do this, a randomized crossover intervention study with 3x14 days full diet periods~     (cheese diet, meat diet or carb diet)will be conducted in 16 postmenopausal women. Between~     the diet periods there will be at least 14 days of wash-out where the subjects eat their~     habitual diets. Fasting blood samples will be drawn before and after the diet periods, and~     also a non-fasting blood sample will be drawn after the diet periods. Furthermore, total~     feces is collected the last 5 days of each diet period.~   "
139673|NCT01739140|"~     This is a study to better understand how a yoga intervention helps improve symptoms in people~     with chronic low back pain. This study will be a 12-week intervention of about 24~     participants with chronic low back pain where all individuals will receive weekly yoga~     classes and instructions for home practice. The purpose of this study is to collect~     feasibility data and to conduct preliminary analyses in preparation for a larger planned NIH~     study.~   "
139674|NCT01739127|"~     The purpose of this study is to compare abdominal weight gain and fat distribution in people~     taking aripiprazole versus risperidone or quetiapine, to people not taking any of these~     antipsychotic medications.~   "
139675|NCT01739114|"~     To determine if respiratory support at birth guided by RFM decreases BPD.~   "
139676|NCT01739101|"~     Many women and men are at risk for sexual transmitted infections and unwanted pregnancies and~     have unrealistic family planning intentions and insufficient knowledge of health promoting~     lifestyle prior to conception. Without sufficient support from the health care system this~     can lead to negative consequences. The aim of our study was to investigate if the usage of~     the Reproductive Life Plan in midwifery counselling increases women's knowledge of~     reproduction and particularly knowledge of folic acid intake prior to pregnancy. Secondary~     aims were to evaluate the influence on women's family planning and to further explore how~     women experienced the Reproductive Life Plan-based counselling.~   "
139677|NCT01739088|"~     In 2012, infants having surgery for congenital heart disease have a high survival. The~     investigators are now focused on improving how sick these infants become after surgery (short~     term outcomes) and their later neurodevelopment (long term outcomes). During heart surgery,~     cardiopulmonary bypass (CPB; the heart-lung machine) takes over heart function while the~     surgeon repairs the heart disease. During this surgery there are periods of time when the~     amount of blood going to the heart and brain is lower than usual, called ischemia. Once the~     surgery is finished the blood going to the heart and brain is increased to normal again,~     called reperfusion. This ischemia-reperfusion can cause injury to the heart, brain, and~     other organs, affecting the short and long term outcomes in these infants. Adult studies have~     shown that a short time of ischemia to the legs for 5-10 minutes [the legs are not damaged by~     a short time of ischemia, unlike the heart or brain], before severe ischemia to another~     distant vulnerable vital organ [like the heart or brain], can protect this other vital organ~     from ischemia-reperfusion injury. This is called remote ischemic preconditioning (RIPC).~     Our objective is to test whether RIPC before heart surgery can improve the recovery of the~     heart and brain after heart surgery in newborn babies with congenital heart disease. The~     investigators will test whether RIPC will result in lower peak lactate and troponin levels on~     the day after heart surgery. Lactate levels are a marker for how much the different tissues~     of the body suffer from ischemia-reperfusion injury. Troponin is released from damaged heart~     during ischemia-reperfusion. In our trial infants will be randomized to RIPC or control. This~     means each baby has an equal chance of being in one group or the other. The intervention~     group will have RIPC before surgery; the control group will not. The investigators hope~     this trial will lead to a larger study to test if RIPC results in fewer days on a breathing~     machine after surgery, lower mortality, and higher scores on neurodevelopmental tests at 2~     years of age.~   "
139678|NCT01739075|"~     The purpose of this study is to determine whether a novel non-invasive method to estimate~     coronary blood flow (FFRct) is applicable to evaluate the functional significance of coronary~     stenoses in non-culprit vessels in a population of patients with recent STEMI (ST-elevation~     myocardial infarction) and multivessel disease. The diagnostic performance and~     reproducibility of FFRct as well as the qualitative and quantitative correlation between~     FFRct and the regional coronary blood flow will be examined.~   "
139679|NCT01739062|"~     The preferred method for early detection of prostate cancer (PCa) in older men with family~     history is the Prostate Specific Antigen test (PSA test), although the method is imprecise.~     It produces a high number of false-positive results and increases the risk of over-diagnosis~     and over-treatment. Yet, an increasing number of men get the PSA test as part of unsystematic~     screening. Genetic risk assessment may be a better way to identify men with low risk of PCa.~     The main study hypothesis is that genetic information about low risk of PCa can reduce the~     number of patients who get a PSA test as part of unsystematic screening.~   "
139680|NCT01739049|"~     Malaysia has increasing challenges in lifestyle related diseases, which is related to eating~     habits and disorders. According to the National Health & Morbidity Survey in 2011; it was~     reported the prevalence of obesity is 15.1% in 2011; or 2.5 million of the population,; an~     increase of 7/9% when compared to the 14% prevalence in 2006. Binge eating is a symptom~     described in various eating disorders. It is an under-diagnosed medical condition closely~     linked to higher body mass index (BMI) or obesity as well as personality psychopathology,~     psychiatric and psychological disturbances. Meta-analysis has demonstrated that extremely~     strict restriction in dietary calorie and fat intake is needed to achieve meaningful weight~     loss. Appetite and satiety are influenced by extremely complex central and gut-related~     hormonal systems which modulate the regulation of food intake Centrally acting hormones~     include Neuropeptide Y (NPY), agouti gene-related peptide, orexin which are~     appetite-stimulating, melanocortins and alpha-melanocortin-stimulating hormone which promote~     satiety.~      Gut-related peptides include ghrelin secreted by the stomach and the duodenum has orexigenic~     (appetite stimulating) effect; leptin secreted by adipose tissue has anorexic (appetite~     inhibiting) effect, cholecystokinin, glucagon-like peptide-1 (GLP-1) secreted by the proximal~     gastrointestinal tract which has slight anorexic effect, and peptide YY (PYY).~      Appetite and obesity have also been commonly related to stress and may influence binge-eating~     episodes. Previous studies have demonstrated that high stress hormone cortisol is associated~     with increased appetite and cravings, with preference for high carbohydrate content, thus~     leading to weight gain.~      In the previous study performed by our group on 738 normal subjects who were staffs of the~     Ministry of Health, Putrajaya, we found a prevalence of 19% binge eating behaviour, 83% of~     whom were either obese or overweight.~      GLP-1 analogue used for the treatment of type 2 diabetes and is also shown to produce and~     maintain weight loss. Liraglutide, which provides a supra physiological amount of GLP-1 may~     cause appetite inhibition thus may benefit in reducing binge eating. The aim of this study is~     to closely observe the extensive profile of neuropeptide Y, ghrelin, leptin and GLP-1,~     influenced by a standard meal in binge eaters in comparison to non-binge eating controls. In~     addition, we aim to determine the association between binging and the respective~     appetite-related hormones and also cortisol. Finally we will also be assessing the efficacy~     of novel hormonal treatment of Liraglutide in reducing binge eating.~   "
139699|NCT01738802|"~     This study is evaluating the impact of antioxidant supplements on blood sugar control and~     cardiovascular risk factors in adults over the age of 50 with at 3 months of Type 2 diabetes.~     The investigators hypothesize that daily supplementation with a multiple micronutrient~     formulation containing dietary and endogenous antioxidants in combination with usual care~     will reduce markers of oxidative stress and inflammation in Type 2 diabetes.~   "
139681|NCT01739036|"~     This is an open label, multi-centre phase I/IIa sporozoite-challenge trial to assess the~     safety, immunogenicity and efficacy of two combination ChAd63-MVA heterologous prime-boost~     vaccination regimens. All volunteers recruited will be healthy, malaria naïve adults aged~     between 18 and 45 years.~      To determine the efficacy of each of two combinations of heterologous prime-boost~     immunisation strategies:~        1. ChAd63-MVA ME-TRAP combined with ChAd63-MVA CS~        2. ChAd63-MVA ME-TRAP combined with ChAd63-MVA CS and ChAd63-MVA AMA1~      The study will be conducted at the University of Oxford's Centre for Clinical Vaccinology and~     Tropical Medicine (CCVTM), Oxford, UK and the Wellcome Trust Clinical Research Facility in~     Southampton, UK. The malaria challenge will take place at the insectary at Imperial College~     (Infection and Immunity Section) in London, UK.~   "
139682|NCT01739023|"~     The purpose of this study is to assess the safety of autologous human Schwann cells (ahSC)~     transplantation in subjects with subacute SCI.~      For humans with subacute SCI, we hypothesize that axons might show improved function if~     myelin repair is induced with the implantation of ahSC. In addition spinal cord cavitation~     may be reduced, and neural sprouting and plasticity may be enhanced via neurotrophic effects.~   "
139683|NCT01739010|"~     The purpose of this study is to investigate the long term outcome of patients who receive~     hypothermia treatment for spinal cord injury. At this institution, intravascular hypothermia~     has been used for certain patients with spinal cord injury for the past two years. This study~     will collect data from vital signs and examinations while the patient is in the hospital and~     also when they follow up as an outpatient after they are discharged or go to a rehabilitation~     center. This data will then be analyzed and compared only to historically published data from~     previous studies. The aim of this investigation is to determine if intravascular hypothermia~     results in a beneficial outcome for patients with spinal cord injury.~   "
139684|NCT01738997|"~     Although balloon dilatation is the primary treatment for benign dysphagia, information about~     the optimal inflation time is lacking. The aim of the current pilot study was to compare 10~     seconds inflation time, with 2 minutes inflation time, regarding the efficacy~   "
139685|NCT01738984|"~     This Phase II Small Business Technology Transfer(STTR) project will develop and test the~     effectiveness of an interactive web program optimized for use on a Internet connected~     television(TV), titled Moms Exercising or (MomZing) that is designed specifically for women~     with infants 2-8 months old. Moms will select from a menu of 98, 10-minute exercise videos~     demonstrating yoga, aerobics, and strengthening exercises. They select and sequence together~     exercise videos personalized to their fitness level, form of exercise, and the choice to~     actively exercise with her baby or alone. The primary health goal of the MomZing Program is~     to increase home-based Moderate to Vigorous Physical Activity (MPVA) minutes per week in new~     mothers and to maintain their exercise increases over time as their baby grows.~      The investigators hypothesize that women that use the MomZing Program will have greater~     increases in physical activity and fewer will return to cigarette smoking or alcohol use,~     compared to women who use a standard mommy and me exercise DVD.~   "
139686|NCT01738971|"~     Pharmacists do not provide immediate contraception to women after emergency contraception~     (EC); they can only give advice on local contraceptive services.~      The investigators wish to establish the following 2 pharmacy- based interventions in NHS~     Lothian, designed to increase uptake of effective contraception as soon as possible, after EC~        1. Pharmacists would provide one packet of progestogen-only pills, giving women one month~          to arrange an appointment with contraceptive services.~        2. Rapid access to a family planning clinic upon presentation of the empty EC packet. Women~          would be seen as a 'walk-in' and contraception provided.~      If feasible, these interventions could reduce unintended pregnancies.~      Participating pharmacies will be randomised to provide one of the interventions, or standard~     care (verbal/written advice on local contraceptive services).~      Women requesting EC from study pharmacies will be recruited by the research nurse/doctor to~     participate in the study that will involve them consenting to contact by telephone 6-8 weeks~     after EC by the researcher, to evaluate the interventions in terms of :~      (i) determine women's experiences/ views of the interventions and control. (ii) determine if~     women have commenced effective contraception and if not , reasons why.~      A subset of 12 women will also be invited for in-depth interview to collect more detailed~     qualitative data on their EC experience.~      The investigators also wish to (iii) explore pharmacists views on the interventions~      Data from this pilot will enable the investigators to determine whether a larger multisite~     study is feasible. The aims of a larger study being to determine if either of the two~     interventions being tested result in an increased proportion of women using effective ongoing~     contraception compared to the control.~   "
139687|NCT01738958|"~     Clinical trials in children and adults have suggested that daily consumption of probiotic~     lactic acid bacteria can reduce caries risk and caries development in primary teeth in~     preschool and stop root caries in the elderly. However, it is not known whether probiotic~     bacteria can affect the increased porosity in young permanent teeth in children and~     adolescents with many cavities.~      It can be difficult to measure the increased porosity of the enamel by tooth decay, but this~     can be done using quantitative laser fluorescence (QLF). The method is based on visible light~     with a wavelength of 370 nm, addressing enamel. This produces an image consisting of red and~     green color tones and the dominant color of the enamel is green. Increased porosity of the~     enamel, resulting in a reduction of the auto-fluorescence and the loss (or gain) of the~     mineral can be quantified by means of a corresponding software.~      The purpose of this study is to investigate the effect of a daily supplement of probiotic~     lactic acid bacteria on the loss of mineral in enamel assessed with QLF. The null hypothesis~     is that the mineral content will not differ from baseline in either the test group or the~     placebo group.~   "
139707|NCT01738698|"~     The primary purpose of this study is to determine whether SPD489 40 mg, 100 mg, and 160 mg~     are effective and safe in the treatment of Negative Symptoms of Schizophrenia (NSS).~   "
139708|NCT01738685|"~     Hormone responsive breast cancer is common and costly. Long-term adjuvant endocrine therapy~     (AET) improves breast cancer outcomes greatly, but, unfortunately, is commonly associated~     with physical and emotional concerns. I propose to evaluate the feasibility and preliminary~     effectiveness of a behavioral intervention to facilitate problem identification, provide~     education, coaching for breast cancer survivors with symptoms while on AET. Therefore, the~     intervention intends to empower women to engage in better self-care and seek out resources~     they need, which, in turn, will lead to better symptom management.~   "
139688|NCT01738945|"~     In recent years, diabetic nephropathy, which may lead to dialysis treatment, is the most~     prevalent underlying disease of people in developed countries. A wide range of studies have~     been carried out, from various points of view, to understand the progress of renal~     dysfunction in diabetic nephropathy.~      Fibroblast growth factor 23 (FGF-23) is a primary regulator of renal phosphate excretion.~     FGF23 is inversely associated with the GFR, a relationship underlying a fundamental mechanism~     for maintaining serum phosphate constancy during CKD progression. Such an adaptation may have~     deleterious trade-offs because, independently of serum phosphate, high FGF23 signals a high~     risk of death in ESRD patients. Some studies showed that there is relationship between FGF-23~     levels and proteinuria in CKD patients.~      There is no data about the effects of calcium channel blocker on FGF23 levels in diabetic~     patients with proteinuria. The aim of this study was to find out whether the beneficial~     effects of calcium channel blocker in diabetic proteinuria has any relation with the~     alteration of FGF-23 levels. The investigators searched for the effects of calcium channel~     blocker amlodipine on the clinical and laboratory parameters of diabetic patients with~     proteinuria.~      The investigators registered the study 'The effect of renin angiotensin system Blockage~     (RAS), calcium channel blocker and combined drugs on TWEAK, PTX3 and FMD levels in Diabetic~     Proteinuric Patients with Hypertension' (ClinicalTrials.gov Identifier:NCT00921570). The~     investigators will use the samples of the some patients for this study. The investigators~     also registered the study 'FGF-23 and Endothelial Dysfunction in Diabetic Proteinuric~     Patients' (ClinicalTrials.gov Identifier: NCT01703234). The investigators will combine these~     two registered studies (NCT00921570 and NCT01703234) in one study.~   "
139689|NCT01738932|"~     The purpose of the study is to investigate the possible association between low levels of MBL~     and the development of endometriosis~   "
139690|NCT01738919|"~     Mallet finger is an avulsion of the extensor tendon at its insertion on the base of the~     distal phalanx, with or without fracture.~      Treatment af mallet finger fractures involving more than 1/3 of the articulating surface is~     controversial. There are to our knowledge no randomized controlled trials comparing splinting~     and surgical treatment with extension block technique.~      The aim of this study is to compare splinting and surgical extension block fixation of mallet~     finger fractures in a randomized controlled trial.Our hypothesis is that conservative~     treatment with splinting is comparable to surgical treatment concerning functional outcome,~     and may even reduce the complication rates.~      The original protocol was designed to include participants with non-subluxated and subluxated~     mallet finger fractures. However this study only included participants with non-subluxated~     fingers.~   "
139691|NCT01738906|"~     Rationale~      It has been shown in several studies that alcohol increases subsequent food intake. However,~     moderate alcohol consumption has no clear effects on hunger and satiety hormones. In the~     Western world, where palatable food is highly available, food reward may play an important~     role in food intake. Alcohol consumption is known to stimulate neurotransmitters important~     for food reward and may therefore stimulate the reward response on a subsequent meal. This~     may lead to higher food consumption than when no alcohol is consumed. It is hypothesized that~     the reward response of food or beverages can already be generated when food or beverages are~     sensed in the mouth, because oral nutrient sensing is known to induce a satiety response~     (i.e. the cephalic phase response). Moreover, taste buds directly signal brain areas closely~     connected to the reward areas in the brain.~      Primary objective~        -  To determine whether moderate alcohol consumption influences subsequent food reward, as~          measured by questionnaires on food 'wanting' and food 'liking', and salivary and blood~          parameters related to reward.~      Secondary objectives~        -  To determine whether food reward is different when food is consumed than when food is~          sensed in the mouth, as measured by questionnaires on food 'wanting' and food 'liking',~          and salivary and blood parameters related to food reward.~        -  To determine whether moderate alcohol consumption influences subsequent food reward~          differently when food is consumed than when food is sensed in the mouth, as measured by~          questionnaires on food 'wanting' and food 'liking', and salivary and blood parameters~          related to food reward.~   "
139692|NCT01738893|"~     The objective of this study was to confirm if two formulations of gabapentin (capsules) are~     bioequivalent.~      Test product was Darbetin® 300 mg (Laboratorios Dermatológicos Darier) and reference product~     Nerotin® 300 mg (Pfizer). One capsule was the single dosage.~      The study was prospective, open-label, randomized, crossover, single dose, with 02~     treatments, 02 sequences and 02 periods, under fasting conditions.~      The population was composed of 26 healthy volunteers, both genders, adults between 18-55~     years.~      The comparative bioavailability of the two formulations was evaluated based in statistical~     comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations~     in blood.~   "
139693|NCT01738880|"~     In patients undergoing craniotomy, 0.9% normal saline is commonly administered in order to~     reduce cerebral edema. Excessive administration of 0.9% normal saline has been to reported to~     cause hyperchloremic metabolic acidosis. On the other hand, hypovolemia due to insufficient~     fluid replacement for perioperative loss can also result in metabolic acidosis by lactic acid~     accumulation. However, the guideline for perioperative fluid management has not been yet~     established. The investigators hypothesized that intraoperative fluid management according to~     SVV(Stroke Volume Variation)could reduce perioperative metabolic acidosis compared to those~     by CVP(Central Venous Pressure). Therefore, the study is trying to determine if~     intraoperative fluid administration based on SVV could reduce metabolic acidosis when~     compared with CVP in patients undergoing craniotomy due to brain tumor who receive 0.9%~     normal saline as main fluid regimen.~   "
139694|NCT01738867|"~     A total of at least 48 healthy subjects with a history of social drinking will be recruited~     into this single-centre, randomized, double-blind, cross-over study. Subjects will be~     genetically stratified to result in equal numbers of A118G 'AA' homozygotes (n=24) and A118G~     'G' carriers (n=24).~      Subjects will participate in all three treatment periods and will be randomized to receive~     each of the following for 5 days: Treatment A: Placebo, Treatment B: Naltrexone (NTX) 50 mg~     once daily (25 mg once daily for the first two days) and Treatment C: GSK1521498 10 mg once~     daily. A washout period will be of at least 14 days between treatments. Subjects will return~     for a follow-up visit 7-10 days after the final treatment session washout period has been~     completed.~      Subjects will attend the clinical research unit on days 1, 2, 3, 4 and 5 to monitor safety~     and tolerability for both drugs. Subjects will attend the clinical unit on days 4 and 5 for a~     two day assessment, using a series of pharmacodynamic measurements known to be sensitive to~     the effects of GSK1521498 and/or NTX: Functional brain response to alcohol and food cues;~     plasma cortisol; hedonic and consummatory eating behaviors; subjective response to an ethanol~     challenge; experimental pain threshold; and cognitive tests of attention bias towards alcohol~     and food cues.~   "
139709|NCT01738672|"~     Hypothesis: The administration of nitrous oxide for labor analgesia will decrease the labor~     epidural anesthesia rate by 15%.~      Specific Aim: To determine if nitrous oxide can be an effective alternative technique for the~     provision of labor analgesia at Magee-Womens Hospital.~   "
139700|NCT01738789|"~     An adnexal mass is the most common indication for gynaecological surgery . Pre operative~     characterization is crucial and a scoring system would be useful to standardize the imaging~     report and thus, improve patient management. Recently, our center developed the first MR~     scoring system named ADNEXMR SCORING system in a retrospective study which is accurate and~     reproducible (1). Our objectives are to perform an external prospective validation of this~     scoring system, to evaluate its potential impact on therapeutic strategy and to test its~     reproducibility.~      This is a prospective large multicenter study. All patients with a sonographically~     indeterminate adnexal mass referred for MR imaging will be consecutively included in each~     center. Then, patients will undergo a routine pelvic MR imaging. Prospectively, one senior~     and one junior radiologists independently analyze the different MR criteria to characterize~     adnexal masses. The MR report will be issued as standard and the patient will be managed~     accordingly. Then, the reader will classify the mass using ADNEXMR SCORING system. The~     classification will be compared to the reference standard as defined below. The~     reproducibility of the classification will be tested between the junior and the senior~     radiologist. After anonymisation, images will be analyzed by another senior radiologist of~     another center blinded from any clinical or ultrasonographical data and correlated with the~     reference standard.~      Reference standard: Reference standard will be surgical procedure with histology or standard~     clinical follow-up depending on most appropriate routine practice.~      Sample size: The sample size was computed to ensure a power of at least 90% (with a two-sided~     type I error rate of 5%) to conclude that SCORE 2 and 3 and SCORE 4 and 5 would have a~     different PPV. It would thus be necessary to have at least 569 patients classified as SCORE~     2, 259 as SCORE 3, 52 as SCORE 4 and 51 as SCORE 5 (18). Given the prevalences, and assuming~     6% of patients would be classified, as SCORE 1 and 10% would be lost to follow-up, 1340~     patients will be included in this study to insure a probability of at least 95% to obtain the~     aforementioned number of patients in each score category. The inclusion period will last 18~     months (extension for a period of 12 months) and monitoring will continue for 2 years.~      Thomassin Naggara I., et al. Development and preliminary validation of an MRI Scoring system~     for Adnexal Masses. Radiology 2013, May;267(2):432-43.~   "
139701|NCT01738776|"~     Low Body Mass Index (BMI) is a risk factor for hip fracture, but it is unknown if it is the~     low BMI per se that increases risk of hip fracture or if specific micro-nutrients contribute.~     The investigators want to elucidate this aspect in a case control study studying~     micronutrients in serum and bone turnover markers of hip fracture patients compared with~     controls of the same age.~   "
139702|NCT01738763|"~     The purpose of this study was to assess the acute effects of increasing doses of pinitol on~     glucose tolerance and insulin sensitivity and to evaluate the absorption of pinitol after~     consumption of an oral nutritive pinitol-enriched beverage in healthy subjects.~   "
139703|NCT01738750|"~     This protocol examines choice where it pertains to choosing between two standard methods for~     appendectomy, laparoscopic or open procedures, and the affect that cost of the appendectomy~     has upon choice.~      Children admitted with a diagnosis of uncomplicated appendicitis will be consented to~     participate in a study in which the patient can choose between laparoscopic or open~     appendectomy procedures. Those that agree to review a consent form will be randomly placed~     into one of two groups. The two groups consist of one in which the consent form includes~     cost information for each operative procedure in the comparison between the procedures, and~     the other group receives a consent form that does not include cost information for each~     operative procedure. Both groups also view a short, group specific, computerized~     presentation that describes each procedure.~      The hypothesis is that those patients given a choice between two similar surgical procedures~     and are provided with cost information will more often choose the less expensive surgical~     procedure than those that do not have information related to the cost of the surgical~     procedures.~   "
139704|NCT01738737|"~     Osteoarthritis (OA) is a highly prevalent and disabling disease. It is estimated that by 2030~     the prevalence of symptomatic OA could reach 30% of the population above 60 years. It is~     associated with significant morbidity being one of the most common causes of joint pain,~     functional disability and compromised quality of life. This randomised controlled trial will~     investigate the effect of low-level laser therapy (LLLT) and static stretching exercises, as~     monotherapy and in combination, on pain, quality of life, function, mobility, knee range of~     motion (KROM) and hamstring length in participants with knee OA.~      This study will involve 145 people aged 50-75 years with symptomatic radiographic knee OA and~     will consist of two types of treatments: Low-level laser therapy (LLLT) and stretching~     exercises. The patients will be randomly allocated to five study groups LLLT active+Stretch,~     LLLT placebo+Stretch, Stretch, LLLT and Control (with n=29 each). Treatment frequency will be~     three sessions/week for all active groups. LLLT will involve the use of a Galium-Arsenide~     laser (904nm, 40 milliwatts, 3 Joules/point, 27 Joules/knee) over 24 sessions for the~     monotherapy group and 9 sessions for the LLLT+Stretch groups. Stretching will consist of~     seven exercises completed over 24 sessions. The control group will receive a booklet.~      The primary outcome is pain measured by Visual Analogue Scale. Secondary outcomes included~     quality of life assessed by Western Ontario and McMaster Universities Arthritis Index~     (WOMAC), function by Lequesne Algofunctional Index, mobility by Timed Up and Go Test (TUG),~     KROM by goniometry of knee flexion and hamstring shortening by popliteal angle. The~     statistical method will follow the principles of per-protocol analysis.~   "
139705|NCT01738724|"~     The investigators´aim is to assess whether the progestagen dienogest reduces leiomyoma volume~     and its associated symptoms to the same extent as gonadotropin releasing hormone (GnRH)~     analogs or the progestagen desogestrel or whether it is inferior to other drugs already in~     use.~   "
139706|NCT01738711|"~     Idiopathic Pulmonary Fibrosis (IPF) is a chronic progressive lung disease of unknown cause~     for which there is no effective medical treatment. The main symptoms are increasing~     breathlessness and cough which can significantly impact on quality of life (QOL) often~     leading to anxiety and depression. The focus of disease management is shifting from~     pharmacological attempts to reduce disease progression to managing symptoms and a more~     holistic approach. Cognitive behavioural therapy (CBT) is increasingly used to treat anxiety~     and depression in chronic disease. Our investigators aim to determine whether CBT can reduce~     anxiety and depression related to symptoms and improve QOL in patients with IPF. This study~     will compare CBT intervention (Group 1) against standard treatment (Group 2). Patients will~     be recruited from a specialist IPF clinic - all patients attending with IPF who suffer from~     anxiety will be eligible to participate in the study. The study aims to recruit 30 patients~     (15 in each group). Patients will be randomly allocated into each group using an envelope~     concealment system. At entry a baseline visit will be conducted with information gathered~     regarding disease severity, hospital admissions, medication, symptoms (subjective and~     objective), quality of life and anxiety and depression using questionnaires and routine~     clinical tests. Patients will then receive CBT intervention (Group 1) or no intervention~     (Group 2). Patients receiving CBT will undergo a maximum of 6 (minimum of 2) individual~     therapy sessions. Follow up visits for both groups will be conducted at 3, 6, 9 and 12 months~     with the same information gathered as at the baseline visit.~   "
139712|NCT01738633|"~     Background: A recent systematic review showed that patients undergoing esophagectomy for~     cancer had scores of physical function, vitality and performance of health in general~     significantly lower than those obtained from the reference population. The analysis of the~     quality of life at six months follow-up showed that the total score and physical function~     were better before surgery and symptoms-based scales indicated that the fatigue, dyspnoea and~     diarrhea were worse six months after esophagectomy. The objective of this study is therefore~     to assess the impact of esophageal resections for cancer on the quality of life of patients~     and to improve it through simple interventions of post operative care.~      The study is divided into two steps.~      This is step 2.~      At hospital discharge, patients will be randomized into 4 groups receiving respectively:~     nutritional and respirology counseling; nutritional counseling alone; respirology counseling~     alone; standard care. All the patients fill in the questionnaires QLQ C30, OES18, INPAT32 at~     1 and 3 months after the surgical operation. Primary end-points are the items DY (dyspnoea),~     AP (appetite loss) and QL2 of QLQ C30. Secondary end point is the item EA (eating) of OES18.~   "
139713|NCT01738620|"~     Background: A recent systematic review showed that patients undergoing esophagectomy for~     cancer had scores of physical function, vitality and performance of health in general~     significantly lower than those obtained from the reference population. The analysis of the~     quality of life at six months follow-up showed that the total score and physical function~     were better before surgery and symptoms-based scales indicated that the fatigue, dyspnoea and~     diarrhea were worse six months after esophagectomy. The objective of this study is therefore~     to assess the impact of esophageal resections for cancer on the quality of life of patients~     and to improve it through simple interventions of post operative care.~      The study is divided into two steps.~      This is step 1.~      Patients will be randomized into four groups receiving respectively: psychological counseling~     for support plus appropriate measures to reduce sleep-wake rhythm disorders during ICU stay;~     psychological counseling alone; appropriate measures to reduce sleep-wake rhythm disorders~     during ICU stay alone; or standard care. The primary end point are the items SL (sleep~     disorder) and QL2 of the QLQ C30, and the secondary end point is the score of the PSQI.~   "
139714|NCT01738607|"~     The primary aim of this study was to compare the effects of supplementation with one of three~     dietary fibers (gum arabic, carboxy-methylcellulose, or psyllium) or a placebo on fecal~     incontinence (FI), symptom intolerance, and quality of life in community-living individuals~     who have incontinence of loose or liquid feces. A secondary aim was to explore the possible~     mechanism(s) underlying the supplements' efficacy (i.e., improvements in stool consistency,~     water-holding capacity or gel formation).~   "
139715|NCT01738594|"~     This randomized phase I trial studies the side effects and the best dose of carfilzomib when~     given together with or without romidepsin in treating patients with stage IA-IVB cutaneous~     T-cell lymphoma. Carfilzomib and romidepsin may stop the growth of cancer cells by blocking~     some of the enzymes needed for cell growth. It is not yet known whether giving carfilzomib~     alone is more effective than when given together with romidepsin.~   "
139716|NCT01738581|"~     This study is exploring a new experimental procedure in dystonia called repetitive~     transcranial magnetic brain stimulation (TMS) combined with rehabilitation. The purpose of~     the study is to determine whether repetitive TMS is effective as a treatment to reduce~     symptoms in dystonia as demonstrated by improved motor performance.~   "
139717|NCT01738568|"~     Aging is associated with a loss of brain function and conditions such as dementia and~     Alzheimer's disease. It is likely that decreased brain metabolism is contributing to the~     progression of age related degenerative diseases. Aerobic exercise training can increase~     brain volumes and is associated with decreased risk for degenerative brain conditions.~     However, little is know about the changes that occur to brain metabolism with aerobic~     training and aging.~   "
139718|NCT01738555|"~     This study is an open-label extension of RFSP-AMDX-2010 study for those subjects who received~     treatment with amdoxovir (300 mg or 500 mg twice daily) for 12 weeks and benefited from it.~     This study will examine the safety and efficacy of the investigational HIV drug, amdoxovir~     (300 mg and 500 mg bid doses; N = up to 30) in combination with zidovudine and~     lopinavir/ritonavir for 36 weeks.~      Subjects will continue to receive either amdoxovir 300 mg twice daily or amdoxovir 500 mg~     twice daily, each in combination with zidovudine 300 mg twice daily and lopinavir/ritonavir~     (400 mg/100 mg twice daily) for additional 36 weeks.~   "
139719|NCT01738542|"~     A prospective study, proof-of concept, randomized, controlled, parallel groups, simple blind~     was performed in 30 male patients (50-60 years old) with Intermittent Claudication~     (Rutherford category 1-2) recently diagnosed and clinical manifestations not exceeding 6~     months with hypertension and/or dyslipidemia as unique co-morbility disorders. After a period~     of stabilization of the claudication distance in the Stress test (12.5%, 3.2 km/h) during 2~     weeks, were randomized 1:1 to the experimental arm (Bosentan 62.5 mg twice daily/four weeks~     and 125 mg twice daily/eight weeks) or control group.~   "
139720|NCT01738529|"~     A blinded prospective observation and methodology study with Confocal Laser Endomicroscopy~     (CLE) together with standard white light colonoscopy including inter- and intra-observation~     of patients with Crohn's disease.~   "
139721|NCT01738516|"~     Electroencephalography (EEG) with very high spatial resolution (HR-EEG, 256 electrodes) allow~     for better analysis of local and global activity of the cerebral cortex, as compared with~     conventional EEG. Since January 2012, the Neurology Department of CHU Rennes is the first~     clinical service in France equipped with such a system.~      Applied to HR-EEG recordings, brain connectivity methods are likely to provide essential~     information (in the form of connectivity graphs) on cortical networks, either dysfunctional~     or not, involved in the generation of interictal paroxysms (like spikes or spike-waves) and~     during seizures.~      So far, many methods have been proposed (see for a review: Wendling et al., 2009; Wendling et~     al., 2010). However, since each method is highly sensitive to the type of model that is~     assumed for the underlying relationship between distinct brain regions (Ansari-Asl et al.,~     2006), none of them has yet demonstrated its effectiveness.~   "
139770|NCT01737866|"~     A phase 1, open-label study in subjects with normal renal function and subjects with various~     degrees of renal insufficiency, including patients with end-stage renal disease (ESRD)~     requiring hemodialysis. The primary objective is to evaluate the single-dose PK of AMG 423 in~     subjects with various degrees of renal insufficiency, including patients with end-stage renal~     disease requiring hemodialysis.~   "
139722|NCT01738503|"~     This is an open-label study in treatment seeking opioid-dependent subjects for safety,~     tolerability, pharmacokinetics (PK), efficacy markers, and opioid receptor availability of~     subcutaneous injections of depot buprenorphine after induction and stabilization of treatment~     seeking subjects onto Subutex.~      Subjects were planned to receive 4 subcutaneous (SC) injections of RBP-6000 separated by 28~     days (Cohorts 1-5) or 6 SC injections of RBP-6000 separated by 28 days (Cohort 6) after a~     13-day induction and dose stabilisation period on SUBUTEX Sublingual (SL) tablet at dose~     levels of 8-24 mg.~   "
139723|NCT01738490|"~     The overall aim of the study is to investigate the Ponto wide implant considering; initial~     implant stability, stability over time, skin reaction and long term success when loaded at 3~     weeks post surgery. Patients' quality of life improvements following implantation will also~     be surveyed.~      More specifically the primary objective of this clinical study is to test the hypothesis~        -  The new Ponto wide diameter implant offers increased implant stability measured as ISQ~          (implant stability quotient) compared to the previous generation Ponto implant.~      And the secondary objective is to~        -  Investigate when in time implant stability is the lowest as the initial mechanical~          stability is gradually replaced by biological stability~   "
139724|NCT01738477|"~     The purpose of this follow-up study is to evaluate the persistence of antibodies against all~     the vaccine antigens 10 years after booster vaccination with either Tdap or Td, and also to~     assess immunogenicity and safety of another dose of Boostrix, administered in this study.~     This protocol posting deals with objectives and outcome measures of the extension phase. The~     objectives and outcome measures of the primary phase are presented in a separate protocol~     posting (NCT number = NCT00109330).~   "
139725|NCT01738464|"~     This research study seeks to provide more insight as to how the microbiome affects or is~     affected by conditions causing chronic pelvic pain such as Interstitial Cystitis (IC),~     Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS), Lower Urinary Tract Symptoms~     (LUTS), or Overactive bladder (OAB). Depression and many chronic pain disorders are often~     related and are poorly understood, and treatment is often not helpful. The goal of this study~     is to explain pelvic pain characteristics and causes by studying microbiomes of healthy~     people compared to people suffering from IC, CP/CPPS, LUTS, OAB, and Major depression.~   "
139726|NCT01738451|"~     This is a Phase I, multicenter, 2-part study with Part 1 designed as a safety lead-in and~     Part 2 designed to evaluate the effect of GSK2118436 on cardiac repolarization (corrected QT~     interval [QTc] duration) as compared with placebo in subjects with V600 BRAF~     mutation-positive tumors.~      Each part of the study will consist of screening (14 days prior to the start of the study~     treatment), treatment and follow-up period (14 days).~      In Part 1 in Cohort 1 six subjects will receive GSK2118436 225 mg twice a day (BID) on study~     days 1 to 7 and a single 225 milligram (mg) dose on morning of Day 8. Based on the safety~     data of subjects in Cohort 1 subjects will be enrolled in Cohort 2 and the dose of GSK2118436~     will be escalated to 300 mg BID. If the 225 mg dose of GSK2118436 is not well tolerated in~     Cohort 1 (i.e., 2 or more dose-limiting toxicities [DLTs]), then Cohort 2 of Part 1 will not~     be initiated and a dose of 150 mg BID of GSK2118436 will be administered in Part 2 of the~     study. In Cohort 2 six subjects will receive GSK2118436 300 mg BID on Study Days 1 to 7 and a~     single 300 mg dose on the morning of Day 8. Based on the safety data of subjects in Cohort 2~     subjects will be enrolled in Part 2. If the 300 mg BID dose level of GSK2118436 is not well~     tolerated, then the highest tolerated dose will be selected for Part 2 of the study.~      In Part 1 of the study the decision to proceed to the next cohort or Part 2 of the study will~     be based on the safety data of at least 6 evaluable subjects (<=1 DLTs during the 14 days~     following the first dose of GSK2118436).~      In Part 2 of the study eligible subjects will receive a single dose of GSK2118436/placebo (4~     capsules of 75 mg/highest tolerated dose) orally on the first 2 days of the study followed by~     2 doses daily for 6 days and a single dose on the 9th day. There will be 1 day when a placebo~     will be given.~      In both the parts of the study serial blood samples for pharmacokinetic (PK) analysis for~     GSK2118436 and its metabolites (GSK2285403, GSK2298683 and GSK2167542) will be obtained at~     the same time points on the first and last day of dosing (2nd day of dosing also included for~     Part 2). Safety electrocardiogram (ECG)s will be performed at several timepoints during the~     study. In Part 2 Holter ECG monitoring will be performed for 24 hours on the 1st, 2nd and 9th~     days of dosing.~   "
139727|NCT01738438|"~     In this research study, we are looking at the anti-tumor effects of Cabozantinib (XL184) in~     metastatic breast cancer. Data suggest that MET expression and activation are important for~     initiation and progression of triple-negative breast cancer (TNBC). We evaluated the efficacy~     of cabozantinib (XL184), a novel inhibitor of multiple receptor tyrosine kinases, including~     MET and VEGFR2, in patients with metastatic TNBC.~   "
139728|NCT01738425|"~     The objectives of this single center, randomized, double-blinded, placebo-controlled Phase I~     clinical study are to evaluate the safety and tolerability of five (5) single and four (4)~     multiple increasing oral doses of GIC-1001 compared to placebo, and to evaluate the~     pharmacokinetics of GIC-1001 following single and multiple-dose administration in 80 healthy,~     18-50 years old male and female subjects. Moreover, the effect of food on the~     pharmacokinetics of GIC-1001 in healthy subjects will be assessed. This study is designed~     with an integrated, adaptive approach which allows the evaluation of single and multiples~     doses of GIC-1001 in a progressive, overlapped fashion.~   "
139729|NCT01738412|"~     The purpose of this study is the validation of an Electroencephalograph based algorithm for~     detection of onset and deterioration of Acute Ischemic Stroke by Comparison to NIHSS.~   "
139730|NCT01738399|"~     The purpose of the study is to investigate the long-term (24 weeks) effects of coffee~     consumption on insulin sensitivity in insulin resistant individuals.~   "
139731|NCT01738386|"~     Background:~      - Frontotemporal dementia (FTD) is the second most common cause of early-onset dementia.~     Alzheimer s disease is the most common. Alzheimer s disease happens most often in the~     elderly, but FTD typically appears between 40 and 60 years of age. It also has a strong~     genetic component: Up to 40% of FTD cases are linked to positive family histories. Earlier~     diagnoses and genetic tests mean that people with FTD will spend more years in earlier stages~     of disease, aware that they have it. However, few studies have looked at the personal~     experiences or coping styles of people with FTD. Researchers want to interview people with~     FTD and their caregivers to understand their experiences with the disease. This information~     will help create better treatments and therapies for those affected by FTD.~      Objectives:~      - To study the experiences of persons with FTD and their primary caregivers.~      Eligibility:~        -  Individuals at least 18 years of age who have been diagnosed with FTD.~        -  Primary caregivers (spouse or partner at least 18 years of age) of individuals who have~          been diagnosed with FTD.~      Design:~        -  Before FTD participants are recruited, a pilot study will test the interview questions.~          This pilot study will be given to people with Alzheimer s disease and their caregivers.~          It will study how well people with dementia understand the interview questions.~        -  FTD study participants will be recruited through dementia care centers.~        -  All participants will have in-person interviews. These interviews will take up to 1~          hour.~        -  Participants with FTD will answer questions about their experience with the disease.~          They will talk about their mental abilities, challenges, and coping strategies.~        -  Caregivers will answer questions about their experience in caring for someone with FTD.~          They will talk about their challenges and coping strategies. They will also talk about~          the person with FTD, and how aware they believe that the person is of the dementia~          symptoms.~        -  All participants will receive a small gift card as compensation for their time.~        -  No treatment will be provided as part of this study.~   "
139732|NCT01738373|"~     The aim of this registry is to provide information, in day-to-day practice, on Plerixafor~     prescription modalities in France, over a 13-month period in order to address the health~     authorities' request.~   "
139733|NCT01738360|"~     Primary objectives :~        -  To investigate the safety and the tolerability of ATO by IV infusions to patients with~          SLE,~        -  To determine the maximum tolerated dose of ATO.~      Secondary objectives :~        -  Evaluation of the clinical and biological response of the SLE to ATO,~        -  Time of relapse in case of positive response,~        -  Determination of the efficacy,~        -  Pharmacokinetic study of ATO.~   "
139735|NCT01738334|"~     Adults with Attention Deficit Hyperactivity Disorder (ADHD) have impairments in attentional~     subsystems of alerting and conflict monitoring. Mindfulness meditation may lead to an~     improvement of these deficits, and reduces symptoms of anxiety and depression. However, the~     studies that demonstrated these improvements did not use a control group, nor controlled the~     use of medication. In the present study the investigators will examine the effects of the~     mindfulness practices (same protocol of 8 weekly sessions used in the study that showed~     positive effects in this disorder) in the performance of adult patients and healthy people~     (with ADHD). Cognitive performance, mood, and the quality of life will be assessed by~     validated questionnaires before and after treatment/standby.~   "
139736|NCT01738321|"~     To date, there are no data in the literature regarding changes in the intracuff pressure~     during prolonged surgical procedures. It is possible that the pressure will increase over~     time related to gas expansion during equilibration to body temperature. If this is the case,~     these patients may be at risk for tracheal damage. This is a prospective study to evaluate~     the changes in intracuff pressure over time during prolonged surgical procedures.~   "
139737|NCT01738308|"~     The goal of this study is to assess the benefits of Healing Touch, an energy based therapy on~     post-operative discomfort and the rate of recovery in children. The aims of this study are to~     measure the effect of Healing Touch on post-operative: 1) anxiety, 2) emergence agitation/~     emergence delirium (EAD), 3) pain, 4) time to wake-up, 5) time to meet PACU's departure~     criteria, 6.) maladaptive behaviors 2 weeks following surgery & 7)readmissions for~     complications 2 weeks following surgery.~      This is a triple blinded randomized controlled trial with three parallel groups. 240~     subjects, ages 3 or 4 will be randomly assigned to receive the usual post-operative care, the~     usual care plus a post-operative Healing Touch treatment, or the usual post-operative care~     plus a sham Healing Touch treatment done by an untrained research assistant. The participants~     & parents, the evaluators, and the principle investigator will be blinded to study group~     assignment.~   "
139738|NCT01738295|"~     The present proposal investigates the role of the cholinergic system (the neurotransmitter~     acetylcholine) in improving vision and visual attention. Vision results from a complex~     processing of particular stimuli of the visual field. Attention enhances and prolongs the~     neural representations of visual input in the visual cortex. It has recently been shown that~     attention in the visual cortex depends on cholinergic mechanisms. The action of acetylcholine~     in the visual cortex consists in enhancement of the responsiveness to thalamocortical inputs,~     depression of local neuronal connections or extrastriate feedback projections and induction~     of gamma synchronisation. The investigators hypothesize that these effects are associated~     with long-term changes in functional connectivity in the visual cortex, visual attention and~     visual learning (improvement of the visual capacities).~      In the present proposal, the investigators will test whether the administration of donepezil~     (Aricept, 5mg), a drug that increases the level of acetylcholine in the brain, will enhances~     the perceptual-cognitive abilities of young adult subjects. Perceptual-cognitive performance~     will be assessed in a multiple object tracking (MOT) task in a 3D automatic virtual~     environment. MOT is a task where observers are asked to maintain attentional focus on a~     limited number of preselected subgroup of elements in a dynamic scene. Multifocal attentional~     mechanisms are necessary to process the information. The task will be tested five time at one~     week interval to test whether donepezil and training improved the task performance of the~     subject, i.e. lead to perceptual learning. This study could help establish an intervention~     procedure to improve visual performance of subjects that need it.~   "
139739|NCT01738282|"~     The purpose of the study is to assess the efficacy of Xylka® (baclofen) compared to placebo~     on continuous abstinence rate during 20 weeks of treatment, after withdrawal, in alcohol~     dependent patients receiving Brenda therapy sessions.~   "
139740|NCT01738269|"~     Aim of this study is to provide specimens for establishing reference values of HE4 in an~     apparently healthy Chinese population using the Roche Elecsys HE4 assay tested on variety of~     Elecsys and cobas brand immunoassay analyzers. This reference range will be compared to~     population of subjects who have signs and symptoms of various benign and malignant diseases,~     including ovarian cancer. This reference range will also be compared to the levels of HE4 in~     individual subjects who have been diagnosed with ovarian cancer and are being followed~     longitudinally for recurrence or progression of their disease.~   "
139741|NCT01738256|"~     The purpose of this study is to examine the effectiveness and applicability of different~     interventions designed for enhancing overall wellbeing. Lifestyle changes, as well as~     psychological and physiological health variables are assessed. The interventions are based on~     the principles of cognitive behavioural therapy, and delivered either face-to-face, via~     mobile phone application, or Internet.~   "
139742|NCT01738243|"~     Thyroid eye disease (TED) is an autoimmune disease that affects the eye area. The disease~     presents with a variety of physical findings, including bulging of the eyes (proptosis),~     upper and lower eyelid retraction, and swelling/inflammation of the eye itself.~      The disease passes through two phases: active and inactive. The active phase lasts between 18~     and 24 months. During this phase, TED signs and symptoms generally worsen and then often~     improve. The inactive phase follows, during which the signs and symptoms of TED cease to~     improve and usually stabilize.~      Lid retraction is a cardinal sign of TED. In addition to potentially causing cornea damage~     due to improper lid closure, lid retraction is also very troublesome for patients due to its~     cosmetic appearance. The precise pathophysiology of lid retraction is poorly understood, but~     a leading hypothesis is that it occurs due to scarring and fibrosis in the muscles that lift~     the eyelid.~      Currently, the definitive treatment for lid retraction is surgery, which can be used to~     lengthen the lid itself or remove inflamed tissue from behind the eye, thus causing the eye~     to bulge less. In cases when patients first present to their physician with corneal~     ulceration or compression of the optic nerve, surgery may be performed immediately. However,~     in most instances, surgical procedures are delayed until the active stage of the disease has~     passed. Thus, most patients must endure the cosmetic and irritant symptoms of TED for up to~     two years.~      Hyaluronic Acid Gels (HAG) have been FDA approved for the treatment of facial rhytids~     (wrinkles). They are injected under the skin and work by increasing volume. Recently, some~     smaller retrospective research studies have shown that HAG is also effective in correcting~     upper and lower eyelid retraction in TED. Hence, HAG may be for patients with active stage~     TED. It is also thought that if employed early in active phase disease, HAG may also help to~     decrease the severity of associated symptoms and reduce the need for surgery.~      The purpose of the current investigation is to define the clinical utility of HAG correction~     of upper eyelid in active TED in terms of anatomic (lid position), quantitative (corneal dry~     eye signs) and qualitative effects (symptom severity and thyroid related quality of life).~   "
139771|NCT01737853|"~     The objective of this phase IV clinical multi-center trial will be to compare the efficacy~     and safety of Ganforti® versus Krytantek®, using a cross-over design during a six month~     period (including a one-month wash-in period) in POAG and OH patients.~   "
139743|NCT01738217|"~     This is a prospective, monocentric, non-randomized, phase I-II study. The goal is to assess~     the faisability and the capabilities of fluorescence imaging in hepatic surgery, and~     specially to help the surgeon while performing liver surgery.~      This study will be performed on patient intended to undergo a liver cancer surgery.It will~     contain three steps, assessing the following items:~        -  Step 1: to assess the faisability of the use of the Fluobeam, in actual clinical~          surgical conditions and validate the data obtained in the preclinical phase,~        -  Step 2: to assess the ability of the combination of ICG and Fluobeam to mark hepatic~          lesions,~        -  Step 3: to assess the ability of the combination of ICG and Fluobeam to help in guiding~          per-hepatectomy.~           3 to 6 patients will be enrolled in the first step, 20 in the second step and 20 in the~          third step.~      Patients will be followed during 4 weeks after the surgery.~   "
139744|NCT01738204|"~     In order to learn more about women's health issues that occur over the lifespan, the Women's~     Health Study: from Adolescence to Adulthood is building a biorepository and database. The~     biorepository collects, processes and stores samples (such as urine, saliva, blood, cells,~     tissue and peritoneal fluid) until they are needed for research. The database contains~     de-identified information about our study participants. The biorepository and database are~     being created to serve as a resource for researchers from Boston Children's Hospital, Brigham~     and Women's Hospital and outside institutions.~   "
139745|NCT01738191|"~     The purpose of this study is to determine the safety and effectiveness of a drug called~     atomoxetine for the treatment of cognitive impairment for Parkinson 's disease. Atomoxetine~     (ATM) is an approved drug currently on the market for the treatment of attention deficit. It~     works to increase the amount of norepinephrine (a chemical in the brain that helps keep us~     awake and alert) in our brain. ATM has not been approved by the Food and Drug Administration~     (FDA) to be used in the treatment of PD.~   "
139746|NCT01738178|"~     Parkinson's disease is a common neurodegenerative disorder in which patients experience~     progressive motor disability and many disabling non-motor symptoms. Recent studies have~     consistently found that people who do not use caffeine are at higher risk of developing~     Parkinson's disease. This suggests that caffeine may have potential as a treatment for PD.~      In a pilot study of caffeine for daytime sleepiness in PD, there was evident benefit on the~     motor manifestations of disease. There have been other lines of evidence that have suggested~     caffeine could be useful in PD. This study is to evaluate the efficacy of caffeine 200 mg BID~     vs matching placebo for motor and non-motor aspects of disease. This will be in three stages.~     In the first six-month stage, medications will be held constant, to see whether caffeine does~     have motor benefits. Then we will perform a four-year extension stage to define if the~     effects of caffeine persist (or even magnify), and to see if caffeine helps reduce dose of~     other PD meds and/or prevents their side effects. Finally, we will finish with a six-month~     stage in which we will place all patients on caffeine - this will allow us to assess~     caffeine's use in later disease, but more importantly, will assess whether early use of~     caffeine produces long term changes beyond its immediate effects.~   "
139747|NCT01738165|"~     The purpose of this pilot study is to collect data on the safety and effectiveness of the~     KineSpring System in patients with primarily unicompartmental medial knee osteoarthritis.~   "
139748|NCT01738152|"~     The purpose of this study is to see whether it is feasible to conduct a study to determine if~     the use of hyaluronic acid (HLA) vaginal gel (HyaloGYN®) improves vulvovaginal health.~      This study aims to look at whether or not HyaloGYN® is effective in women with a history of~     hormone receptor positive cancer and experiencing vaginal and/or vulvar symptoms of estrogen~     deprivation following their breast and endometrial cancer treatment.~   "
139749|NCT01738139|"~     The goal of this clinical research study is to find the highest tolerable dose of the~     combination of ipilimumab and imatinib that can be given to patients with advanced cancer.~     The safety of this drug combination will also be studied.~      Ipilimumab is designed to increase the immune system's ability to fight cancer.~      Imatinib is designed to bind to certain proteins on the tumor cells, which may prevent the~     cells from growing.~      This is an investigational study. Ipilimumab is FDA approved and commercially available for~     the treatment of unresectable or metastatic melanoma. Imatinib is FDA approved and~     commercially available for the treatment of advanced or metastatic gastrointestinal stromal~     tumor (GIST).~      The combination of ipilimumab and imatinib is currently being used for research purposes~     only.~      Up to 96 participants will take part in this study. All will be enrolled at MD Anderson.~   "
139750|NCT01738126|"~     This K01 application is designed to prepare the applicant with the skills necessary to~     establish an independent research program on pain--related processing in the cerebellum.~     Although pain studies using functional imaging in humans consistently find cerebellar~     activation, the role of this structure during pain is unknown. In such studies, speculation~     regarding the cerebellum's function during a painful event is often influenced by its~     reputation as a coordinator of motor function, though animal studies have indicated that it~     may also modulate the neural encoding of noxious stimuli. The candidate has published work~     that indicates a functional dichotomy in the way the cerebellum responds to experimental pain~     in healthy subjects and neuropathic pain patients. This suggests that the cerebellum has been~     overlooked as a potential pain processing area, and research into this area could lend~     invaluable insight into the basic physiological circuitry involved with pain and its~     modulation.~      The hypothesis of this project is that the cerebellum serves as an integrator of aversive~     stimuli and adaptive motor behavior, and may modulate the emotional and cognitive experience~     that distinguishes the perception of pain from the appreciation of innocuous sensory~     stimulation. A human trigeminal model of experimental pain will be used, as all the~     pain--‐related circuitry involved can be imaged along with the cerebellum at the same time.~     The specific aims are (1) to map cerebellar activations related to sensory coding of noxious~     stimuli and to correlate functional activity with anatomical connectivity using functional~     magnetic resonance imaging (fMRI) and diffusion tensor imaging (DTI); (2) to distinguish~     between pain and its anticipation based on cerebellar responses and connectivity; and (3) to~     determine whether physical pain and aversive images engage similar circuitry in the~     cerebellum. To accomplish these aims, the candidate will need to expand his background in~     fMRI of cortical and brainstem pain processing to encompass cerebellar physiology, become~     proficient in DTI analysis, and learn the white matter connectivity to and from the~     cerebellum. The research environment at McLean Hospital and the other affiliates of the~     Harvard Medical School system will provide the candidate with the resources to reach his aims~     within 4 years.~   "
139768|NCT01737892|"~     This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine~     Inhalation Aerosol USP, an HFA-MDI (E004), using a stable isotope deuterium-labeled~     epinephrine (epinephrine-d3) to differentiate the administered drug from the endogenous~     epinephrine, in healthy male and female adult volunteers. The current study is designed to~     complement an earlier PK study, API-E004-CL-B, for a more thorough evaluation of the E004 PK.~     Safety of E004 will also be evaluated.~   "
139769|NCT01737879|"~     The purpose of this study is to evaluate whether hemodialysis patients on peginesatide can be~     converted to epoetin alfa by using a predefined conversion table while achieving a stable~     hemoglobin.~   "
139751|NCT01738113|"~     The Ilizarov external fixator is an external skeletal fixator that is used to stabilize or~     lengthen the limb bones. Bone lengthen bone occurs through mechanical distraction on the long~     axis of the bone, thus the method of lengthening is called distraction osteogenesis. This~     method has been shown successful. Unfortunately, it has also been associated with a~     substantial number of complications.~      Muscle shortening and persistent weakness are among the most common complications seen in~     this procedure. Muscle shortening usually occurs in strong muscle groups such as the planter~     flexor muscles, as a result of strength imbalance between the opposing muscle groups.~     Shortening may persist for more than a year after the removal of the fixator and may require~     surgical intervention. Fortunately, muscular shortening can be prevented by splinting and~     physiotherapy in the form of stretching and strengthening exercise and functional training.~      The use of different exercises in rehabilitation can help accomplishing different therapeutic~     goals. Thus, the choice to use one or the other should depend on the desired treatment goals.~     Weight bearing (CKC) and non weight bearing (OKC) exercise has been incorporated into~     rehabilitation; however, the effects of these two types of exercises particularly on muscle~     flexibility and mechanics have never been studied systematically.~      Therefore, the purpose of this is to compare the effects of OKC and the CKC exercise on~     muscle strength, architecture and flexibility.~      General Hypothesis:~      The use of open kinetic or closed kinetic chain exercises will have no different effects on~     muscle function or internal organization during tibial distraction osteogenesis by Ilizarov's~     method Specific hypotheses~        1. There will be no difference between the effects of OKC and CKC on muscle flexibility.~        2. There will be no difference between the effect of OKC and CKC exercises on muscle~          strength.~        3. There will be no difference between the effect of OKC and CKC on the internal~          organization of muscle specifically the pennation angle, muscle thickness and fiber~          length.~        4. There will be no difference between the overall of OKC and CKC exercise on the~          functional performance of patients.~   "
139752|NCT01738100|"~     A 2 by 2 factorial, multicenter, prospective, randomized, open-label, blinded endpoint trial.~     Patients undergoing primary PCI for STEMI will be eligible. Enrolled patients will be~     randomly assigned to the ticagrelor group or the clopidogrel group in a 1:1 ratio. After~     emergent coronary angiography, patients who have thrombolysis in myocardial infarction (TIMI)~     flow grade <2 in coronary angiogram will be randomized again, to either bolus intracoronary~     injection of morphine sulfate or saline in a 1:1 ratio. Randomization will be stratified by~     infarct location (anterior vs. non-anterior), and morphine use for pain control before study~     enroll (for only intracoronary morphine).~   "
139753|NCT01738087|"~     The study is aimed to assess the dose proportional total systemic exposure (when the~     administration is without the activated charcoal) to B17MP (active metabolite of BDP) and its~     lung bioavailability (when the administration is with the activated charcoal) after single~     inhalation of CHF 1535 NEXThaler DPI at two dose strengths.~      At the same time, the study will assess if the lung deposition and the total systemic~     exposure to Formoterol is affected by increasing doses of BDP.~   "
139754|NCT01738074|"~     Assessment and evaluation the rotavirus gastroenteritis prevention effect and severe~     rotavirus diarrhea reducing effectiveness of human body, which inoculate trivalent rotavirus~     genetic reassortment vaccine.~   "
139755|NCT01738061|"~     The study was aimed to evaluate the effectiveness of a multidimensional worksite intervention~     program to reduce the severity of metabolic disorders in older workers in Taiwan.~   "
139756|NCT01738048|"~     A cross sectional study to determine the prevalence of persistent pain after reconstructive~     surgery after mastectomy for breast cancer, with a comparative analysis of a cohort treated~     with mastectomy without reconstruction.~   "
139757|NCT01738035|"~     The objective of the study is to evaluate efficacy and safety of two different doses of~     NEFECON in the treatment of patients with primary IgA nephropathy (IgAN) at risk of~     developing end-stage renal disease, under rigorous blood pressure control with an~     angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin II receptor I blocker~     (ARB).~   "
139758|NCT01738022|"~     In obstructive sleep apnea (OSA), the upper airway recurrently closes during sleep. The~     mechanisms that lead to airway closure are not completely understood. Models to study~     mechanisms of airway collapse have been proposed. However, these models have not been tested~     in the human upper airway. Gas density and viscosity are different gas properties that~     influence upper airway collapse and are variables of different models. In this study,~     subjects will breathe gas mixtures of different densities and viscosities for brief periods~     of time in order to test those models.~   "
139759|NCT01738009|"~     In obstructive sleep apnea (OSA), the upper airway recurrently closes during sleep. The~     mechanisms that lead to airway closure are not completely understood. Some studies have shown~     that there is progressive narrowing of the pharyngeal airway across breaths during expiration~     (Progressive Expiratory Narrowing, PEN) preceding an obstructive apnea. The cause of PEN is~     unknown. The investigators will test if lung volumes and low respiratory drive play a role in~     PEN.~   "
139760|NCT01737996|"~     The objective of the current trial is to evaluate safety, tolerability and pharmacokinetics~     of different multiple doses of BI 207127 BID and multiple doses of BI 207127 combined with~     faldaprevir in healthy male and female subjects.~   "
139761|NCT01737983|"~     The purpose of this study is to evaluate in patients with cystic fibrosis the effect of~     Lactobacillus Reuteri (LR) on the rate of respiratory exacerbations and of the infections of~     both upper respiratory and gastrointestinal tracts.~   "
139762|NCT01737970|"~     This research proposal concerns a study to monitor the effects of chemotherapy on breast~     cancer tumour and peritumour stromal cells using ultrasound (US) elastography (also known as~     strain imaging).~      Many cancer treatments currently being developed are targeted; that is they exploit~     particular biological processes in specific cancer cell types to disrupt tumour growth. Being~     able to monitor the efficacy of these typically high-cost drug therapies is essential both~     for the best patient outcome as well as offering economical benefits to the health care~     system and much needed insight into future drug development.~      Ultrasound provides a relatively inexpensive, non-invasive means for imaging cancers, and has~     been used widely in breast cancer diagnosis for many years. Its role in therapy monitoring~     has been suggested but has not been well explored. The purpose of this proposal is to explore~     this potential in more depth.~      It has been identified that significant interaction takes place between tumour and stroma~     through all stages of tumour growth; this complex relationship is an ongoing topic of~     research. Fibrotic changes occur during tumour growth and are also a quintessential process~     of healing. Indeed, fibrosis is a common after effect to chemotherapy in many forms of~     cancer. Elastography is an established imaging technique (based on ultrasound or MRI) which~     can estimate the relative stiffness of tissues in vivo and is thus well-suited to monitor~     these particular biological processes.~      This elucidates the main hypothesis of this project: fibrosis, cancer cell necrosis and~     inflammation may all contribute to a measurable response in elastography. These changes to~     the tissue composition can be imaged over a course of a patient's treatment to assess the~     response to chemo/hormonal therapy.~      The ultimate project goals are to develop a clinical tool (based on ultrasound elastography)~     to improve treatment management in addition to offering a better biological understanding of~     tumour/stroma behaviour.~   "
139763|NCT01737957|"~     To determine the safety and efficacy of a single session of low-fluence panretinal~     photocoagulation when compared to full-fluence PRP. Hypothesis: a single-session of~     low-fluence PRP will be safe regarding the progression of macular edema and the presence of~     adverse events, and will efficiently induce regression of neovascularization.~   "
139764|NCT01737944|"~     Pharmacokinetics (PK) study~   "
139765|NCT01737931|"~     To investigate the efficacy of symptomatic therapy with topical steroids and antihistamines~     for application site reaction (ASR) after administration of SPM 962 in healthy subjects~   "
139772|NCT01737840|"~     The H0 hypothesis of the study is there is no difference between pantoprazole and ranitidine~     in treating patients presented with dyspepsia to the emergency department.~      The H1 hypothesis is there is difference between pantoprazole and ranitidine in treating~     patients presented with dyspepsia to the emergency department.~   "
139773|NCT01737827|"~     This study is to find out if INC280 is safe and has beneficial effects in patients with~     advanced hepatocellular carcinoma known to have dysregulation of c-MET pathway.~   "
139774|NCT01737814|"~     The purpose of this study is to evaluate whether MST-188 can reduce the duration of~     vaso-occlusive crisis (VOC) in subjects with sickle cell disease. The study will also~     evaluate whether MST-188 can reduce the frequency of rehospitalization of subjects due to a~     recurrence of VOC. Additionally, this study will compare the development of acute chest~     syndrome during VOC in subjects who receive MST-188 to those who do not receive MST-188.~   "
139775|NCT01737801|"~     Time to perform lung function test after chest physiotherapy in cystic fibrosis.~      The investigators study FEV1(forced expiratory volume in one second) and FVC (forced vital~     capacity).~   "
139776|NCT01737788|"~     The aim of this study was to evaluate the effect of cervical occlusion versus no cervical~     occlusion in women with cervical cerclages.~   "
139777|NCT01737775|"~     Diaphragmatic dysfunction (DD) is one of the main risk factors for post operative respiratory~     distress syndrome. Ultrasonography is a diagnosis tool for DD but few studies have been~     published. The aim of this prospective study is to compare the achievement of diaphragmatic~     function depending on the type of surgery (abdominal and head and neck surgery).~   "
139778|NCT01737762|"~     This study is being done to find out if an investigational product called HP802-247 can help~     people with venous leg ulcers. Investigational means that HP802-247 has not been approved by~     the U.S. Food and Drug Administration (FDA).~      At least 250 subjects will participate. The study is going to be conducted in approximately~     50 sites in the United States and Canada.~   "
139779|NCT01737749|"~     The primary objective of the study is to check the ability of Neurokeeper's algorithm system~     to detect and monitor changes in cerebral electrophysiological parameters as compared to~     clinical evaluation in patients undergoing cardiac surgery.~      The secondary objectives is correlations of EEG + ERP measurements with clinical evaluations~     as assessed by NIHSS ThiS study is a prospective, open label, single arm, self control,~     single center study.~      This study will be conducted in 50 subjects according to the inclusions/exclusions criteria.~   "
139780|NCT01737736|"~     The primary objective of the study is to validate an EEG base algorithm system to detect and~     monitor changes in cerebral electrophysiological parameters as compared to clinical~     evaluation in patients undergoing Carotid Endarterectomy.~      The secondary objectives is measure time from ICA clamping to algorithm asymmetry detection,~     time from clinical deterioration to algorithm asymmetry detection Thi study is a prospective,~     open label, single arm, self control, single center study.~      This study will be conducted in 50 subjects according to the inclusions/exclusions criteria.~   "
139781|NCT01737723|"~     The purpose of this study is Collecting data for an Electroencephalograph based algorithm for~     detection of onset and deterioration of Acute Ischemic Stroke by Comparison to NIHSS.~   "
139782|NCT01737710|"~     Atopic dermatitis, also called eczema, is a disease in which the skin is dry and scaly with~     severe itching. People who have atopic dermatitis often have complications from skin~     infections; these can include eczema herpeticum after herpes simplex virus infection or~     eczema vaccinatum after smallpox vaccination. People with atopic dermatitis may suffer from~     skin infections and may therefore respond differently to vaccinations.~      A new flu vaccine which is injected into the skin instead of into muscle has recently been~     approved by the Food and Drug Administration for vaccination of the general population~     including patients with atopic dermatitis. This new vaccine has been shown to work as well as~     the vaccine which is injected into muscle when tested in people without atopic dermatitis.~     The main purpose of this study is to compare how people with atopic dermatitis respond to~     this new flu vaccine compared to non-atopic volunteers without atopic dermatitis. The second~     purpose is to look at how people with atopic dermatitis respond to the new vaccine which is~     injected into the skin compared to the vaccine which is injected into muscle.~   "
139783|NCT01737697|"~     Acute Phase: It is hypothesized that ZS (zirconium silicate) is more effective than placebo~     control (alternative hypothesis) in lowering S-K levels in subjects with S-K between 5.0 -~     6.5 mmol/l versus no difference between ZS and placebo control (null hypothesis).~      Subacute Phase (randomized withdrawal): It is hypothesized that ZS once daily is more~     effective than placebo control (alternative hypotheses) in maintaining normokalemic levels~     (3.5 - 4.9 mmol/l) among subjects completing the Acute Phase versus no difference between~     each ZS dose and respective placebo controls (null hypotheses).~   "
139784|NCT01737684|"~     This study will investigate the pharmacokinetics of a single oral dose of vibegron (MK-4618)~     administered to participants with moderate hepatic insufficiency and healthy participants~     matched for age, gender, and body mass index (BMI). Participants may be enrolled with mild~     hepatic insufficiency.~   "
139785|NCT01737671|"~     The goal of this clinical research study is to learn if it is safe to receive methotrexate~     through the fourth ventricle of the brain in patients with brain tumors.~      Methotrexate is designed to block cancer cells from dividing, which may slow or stop their~     growth and spread throughout the body. This may cause the cancer cells to die.~   "
139786|NCT01737658|"~     Obese Adolescents will be evaluated for insulin resistance and cognitive dysfunction.~   "
139787|NCT01737645|"~     This study is to determine if there is a rise in eye pressure, when patients are placed in a~     position where the head is lower than the rest of the body during long surgeries.~   "
139788|NCT01737632|"~     The fundamental objective of this study is to compare the effectiveness of an intensive~     in-home family-based treatment, Multidimensional Family Therapy, with a multifaceted~     residential treatment, Adolescent Residential Treatment, over 4 years post-intake and to~     delineate the mechanisms of change for each treatment. The study targets dually- diagnosed~     adolescent drug abusers recommended for residential treatment.~   "
139789|NCT01737619|"~     The goal of this clinical research study is to compare positron emission tomography/computed~     tomography (PET/CT) scans and sentinel lymph node mapping in finding lymph nodes that have~     endometrial cancer.~   "
139791|NCT01737593|"~     Emergence agitation (EA) occurs in up to 67% of pediatric patients after anesthesia for~     bilateral myringotomy tubes (BMT, ear tubes). The goal of this study is to find out whether~     acetaminophen given well before surgery can decrease pain and therefore, decrease emergence~     agitation better than acetaminophen given shortly before or during surgery. EA can be~     dangerous for the patient because it may be hard to monitor their vital signs during an~     important phase of recovery, they may injure themselves, may require the presence of extra~     staff, and it can be very distressing to the parents. Causes of EA are not well understood,~     but it can be worsened by pain. 70% of patients undergoing BMT experience pain that needs~     treatment. Intranasal fentanyl, a strong analgesic, has been shown to decrease EA, but often~     ends up in dose-dependent nausea and vomiting. In previous studies and in common practice,~     acetaminophen is given either 30 minutes before induction of anesthesia or immediately after~     induction. The peak analgesic effect of acetaminophen is 60-120 minutes. Since the procedure~     is generally completed in 5-10 minutes, the therapeutic effect of acetaminophen may not be~     present upon emergence from anesthesia.~      The purpose of this study is to find out if acetaminophen given 60-120 minutes prior to~     emergence can decrease EA in patients undergoing BMT. Patients would be randomized to one of~     three groups: Control will receive acetaminophen rectally while under anesthesia (standard~     practice), Group 1 will receive acetaminophen 10 mg/kg at 60-120 minutes prior to surgery,~     Group 2 will receive acetaminophen 20 mg/kg at 60-120 minutes prior to surgery. All groups~     would also receive a dose of intranasal fentanyl during the surgery, which is standard~     practice. Patients would be observed in the recovery room at various time points for evidence~     of EA and pain.~   "
139792|NCT01737580|"~     The application of the TLR7/8 (Toll Like Receptor) agonist gel (immune response helper)~     resiquimod will enhance the immune response to the intradermal influenza vaccine in seniors~     65-75 years of age.~   "
139793|NCT01737567|"~     Removal of colorectal adenomas prevents the occurence of colorectal cancers. The use of~     chromo-endoscopy has been shown to improve the detection of flat adenomas. Narrow band~     imaging enables endoscopists to accurately describe the pit pattern of adenomas. By comparing~     White Light Endoscopy and Bright Narrow Band Imaging it will show if there is any comparable~     advantage to using one or the other for lesion detection and assessment.~   "
139794|NCT01737554|"~     Catheter occlusion and dysfunction are common complications of central venous access device~     (CVAD) use in children with cancer and hematologic disorders. These events can lead to~     interruption of therapy and may require device removal and replacement. Attempts to clear~     occlusion can cause device fracture.~      There is a clear link between catheter occlusion and other serious complications including~     bloodstream infection and intravascular thrombosis.~      There is evidence that catheter occlusion or dysfunction may be preceded by subclinical~     catheter narrowing, which could be detected by accurate measurement of catheter resistance.~      This study aims to observe and describe the feasibility and results of catheter resistance~     monitoring (CRM) over time with the aim of prospectively identifying patients at high risk of~     catheter occlusion.~      If CRM is feasible and proves to be sensitive and specific, it could provide an opportunity~     for preemptive therapy to prevent occlusion, which might also prevent bloodstream infection~     or thrombosis.~   "
139795|NCT01737541|"~     This is a randomized, double-blind, placebo-controlled, multicenter clinical trial that will~     be carried out in Mexico. The purpose of this study is to test whether a 3-month treatment~     with fluoxetine enhances motor recovery in non-depressed patients with acute intracerebral~     hemorrhage.~   "
139796|NCT01737528|"~     The TVT Registry™ is a benchmarking tool developed to track patient safety and real-world~     outcomes related to the transcatheter aortic valve replacement (TAVR) procedure. Created by~     The Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC), the TVT~     Registry is designed to monitor the safety and efficacy of this new procedure for the~     treatment of aortic stenosis.~   "
139797|NCT01737515|"~     Despite advances in surgical technique, preoperative patient evaluation and post-operative~     care, elective colorectal surgery carries a risk of mortality of approximately 2% and a~     morbidity rate ranging from 20-40%. Risk prediction is important for two reasons: it informs~     decision-making in individual cases before surgery (part of informed consent) and allows the~     comparison of actual outcome with predicted outcome. A number of scoring systems for~     assessing risk of death after surgery have been developed. They vary from simple scores based~     on a few variables to highly complex mathematical models requiring detailed data input.~     Recently, the Association Française de Chirurgie conducted a multicentre study to develop and~     validate a 4-item predictive score of mortality after colorectal resection which has good~     predictive value and is simple to use.~      Although many surgeons associate obesity with adverse outcomes, recent large, well-designed~     studies have been unable to show that obesity (defined as Body Mass Index (BMI) >30) is an~     independent risk factor for major morbidity or mortality after general abdominal surgery.~     Recently abdominal obesity (waist measurement >102cm in men and >88cm in women) has been~     shown to have better correlation with cardiovascular disease than BMI and is strongly~     associated with a clustering of risk factors for cardiovascular disease and diabetes (insulin~     resistance, hyperglycaemia, hypertension, dyslipidaemia and abdominal obesity) known as the~     metabolic syndrome. Waist circumference and waist/hip ratio are measures of abdominal obesity~     that correlate with the amount of intra-abdominal rather than subcutaneous or general body~     fat and may be a better measure of the risk of intra-operative complications and~     post-operative morbidity following abdominal surgery than BMI.~      The study will be prospective and multicentred, with 28 participating units in Belgium,~     France, Switzerland and Sweden. The coordinating centre will be UCL St Luc. The study will~     start on 1st September 2008 and will aim to include a minimum of 1000 patients. Consecutive~     patients undergoing elective colorectal resectional surgery for cancer or diverticulitis will~     be included. In addition to normal preoperative assessment, waist and hip circumference will~     be measured before surgery and specific data will be collected on intra and post-operative~     complications and mortality. Data will be recorded using an encrypted, anonymous database~     using variables carefully selected to assess short and long term outcomes. The study will be~     the first of its kind to investigate abdominal obesity as a predictive risk factor for~     colorectal surgery and will also be one of the biggest prospective studies of morbidity after~     colorectal surgery.~      The aims of the study are a) to assess if waist measurement or waist/hip ratio is a better~     predictive risk factor for complications or mortality after colorectal surgery than BMI, and~     b) if this measurement adds accuracy to the AFC score in risk prediction.~   "
139798|NCT01737502|"~     This phase I/II trial studies the side effects and best dose of auranofin when given together~     with sirolimus and to see how well it works in treating patients with lung cancer that has~     spread or other places in the body and cannot be cured or controlled by treatment or has come~     back after a period of time during which the cancer could not be detected. Auranofin and~     sirolimus may stop or slow the growth of lung cancer.~   "
139799|NCT01737489|"~     The purpose of this study is to determine if aural rehabilitation adds measurable benefit and~     participant satisfaction to a cochlear implant recipient's overall treatment. Also, the study~     is designed to compare the efficacy of a commercially available aural rehabilitation program~     (LACE) and an electronic program which takes advantage of a traditional form of auditory~     training (NOOK) for cochlear implant users.~   "
139800|NCT01737476|"~     The aim of the study is to investigate the efficacy of trans-cranial magnetic stimulation in~     treating attention deficit disorder in adults.~   "
139814|NCT01737294|"~     This non-interventional study will evaluate the efficacy, tolerability, health related~     quality of life and use of health resources associated with QUTENZA treatment when QUTENZA is~     used in standard clinical practice.~      The patient's primary diagnosis of peripheral neuropathic pain (PNP) will be classified into~     subtypes: post-herpetic neuralgia (PHN); HIV-associated neuropathy (HIV-AN); neuropathic back~     pain; cancer-related neuropathic pain; post-operative & post-traumatic neuropathic pain; and~     'other' neuropathies.~   "
139801|NCT01737463|"~     Endoscopic snare papillectomy (ESP) is an efficient treatment for benign tumors of the~     duodenal major papilla. But post-ESP pancreatitis is the most common and serious~     complication. Since one prospective randomized controlled trial showed that pancreatic duct~     stent placement reduced post-ESP pancreatitis, almost physicians have tried to place the~     pancreatic duct stent after EPS.~      The aim of this prospective, randomized, multicenter trial is to compare the rates of~     post-ESP pancreatitis in patients who did or did not prophylactic pancreatic duct stent~     placement. Consecutive patients who were to undergo ESP were to randomized to pancreatic duct~     stent placement group (stent group) after endoscopic snare papillectomy or to no pancreatic~     duct stent placement group (no stent group).~   "
139802|NCT01737450|"~     The aim of this study is to determine the activity, to assess the safety and tolerance of~     BKM120 in adult patients with recurrent or metastatic head and neck cancer progressive under~     platin and cetuximab-based chemotherapy.~   "
139803|NCT01737437|"~     A previous study demonstrated topical lidocaine spray on the larynx and the trachea is~     effective in reducing hemodynamic response to laryngoscopy and endotracheal intubation. In~     clinical practice, blind oropharyngeal application of lidocaine without aiding direct~     laryngoscopy can not assured that sprayed lidocaine effectively reaches the larynx and~     trachea. Therefore, direct laryngoscopy should be necessary to reach topical lidocaine to~     correct sites. Unfortunately, direct laryngoscopy itself can affect hemodynamics during~     spraying lidocaine. In this study, we will investigate an effect of lidocaine sprayed on~     direct laryngoscopy and the tracheal mucosa on hemodynamic change throughout intubation.~   "
139804|NCT01737424|"~     To investigate the safety, tolerability and pharmacokinetic characteristics of LC28-0126 in~     healthy male subjects~   "
139805|NCT01737411|"~     The purpose of this study is to determine if pelvic surgery can improve urge urinary~     incontinence in women more than standard medical treatment.~   "
139806|NCT01737398|"~     The purpose of this study is to evaluate the efficacy and safety of IONIS-TTR Rx given for 65~     weeks in patients with Familial Amyloid Polyneuropathy~   "
139807|NCT01737385|"~     This study examines the microcirculation of the caput humeri after proximal humeral~     fracturation using O2C light probes.~      During the operation the blood circulation is measured at four points (tuberculum majus,~     tuberculum minus, neck and head of the humerus) directly on the bone. The O2C light probes~     are a none-invasive technique of measuring blood flow, velocity and oxygen concentration. The~     data is analysed in respect to the fracture type according to the classification of Neer.~      Valuable additional information for the correct treatment and prognosis of humeral fractures~     is expected.~   "
139808|NCT01737372|"~     This study will look at the blood and cerebrospinal fluid of consented participants who~     either have early stage multiple sclerosis (clinically isolated syndrome) or who have later~     stage (secondary progressive multiple sclerosis), or participants who do not have any~     neurological or autoimmune illness. Biomarkers and microRNA will be assessed for group~     differences.~   "
139809|NCT01737359|"~     This is a double-blind Phase 2a study to test the safety and efficacy of an investigational~     HIV drug, amdoxovir (300 mg or 500 mg twice daily) compared with tenofovir DF 300 mg once~     daily in HIV-1 infected antiretroviral therapy-experienced subjects who are currently failing~     antiretroviral therapy. There are three treatment groups (N=45). Subjects will be randomized~     to receive either amdoxovir 300 mg twice daily (n=15) or amdoxovir 500 mg twice daily (n=15)~     or tenofovir DF 300 mg once daily (n=15); each in combination with zidovudine 300 mg twice~     daily.~      The study will assess initially amdoxovir (300 mg or 500 mg twice daily) or tenofovir DF 300~     mg once daily, both in combination zidovudine 300 mg twice daily plus failing third drug, but~     then with lopinavir/ritonavir (400 mg/100 mg twice daily) after Week 2. Subjects who received~     amdoxovir (300 mg or 500 mg twice daily) and benefited from the drug may choose to enroll in~     the 36-week open-label study.~   "
139810|NCT01737346|"~     The combination therapy of temozolomide and radiation has been established as the standard~     therapy for the initial treatment of glioblastoma. However, the prognosis for patients with~     recurrent/ refractory glioblastoma is dismal, with a median survival of 3~6 months. There is~     no efficient and standard care at the time of recurrence or progression following~     temozolomide administration. Recently, many clinicians have reassessed the efficacy of~     second-line chemotherapeutic agents such as nitrosoureas for the treatment of~     recurrent/refractory glioblastoma. It is very important that the effect of the agent is~     sustained and the adverse effect is reduced to preserve the quality of life in recurrent~     settings. We have realized that the clinical features of Korean patients are very different~     from those of foreign patients. Therefore, it is mandatory to develop the new strategy for~     the treatment of Korean patients. We modify the PCV chemotherapy in the dose and~     administration schedule of CCNU and procarbazine to reduce the side effect, especially~     hematologic problems. The dose of CCNU is reduced to 75mg/m2 and the interval between CCNU~     and procarbazine is increased. Moreover, vincristine is excluded because BBB permeability of~     vincristine is very poor and the risk of neurotoxicity is high. We introduce the modified PC~     chemotherapy regimen for the treatment of recurrent/refractory glioblastoma, which is the~     first multicenter trial for glioblastoma patients in Korea.~   "
139811|NCT01737333|"~     Collection of data from different sites regardless of whether they use standard or tailored~     protocols for the application of high concentration iodinated contrast agents to assess if~     the individually patient-adapted protocols result in a similar diagnostic image quality.~   "
139812|NCT01737320|"~     The investigators plan an open label randomized controlled trial to compare short-course~     antibiotic therapy (<=7 days) versus longer treatment (>7 days). The investigators will~     include hospitalized patients with gram-negative bacteremia. The investigators primary~     objective is to investigate the safety and efficacy of short-course antibiotics.~   "
139813|NCT01737307|"~     The purpose of this study was to investigate the effect of Fluoride varnish and Casein~     Phospho-Peptide Amorphous Calcium Phosphate (CPP-ACP) containing paste on oral symptoms and~     salivary characteristics in patients under chemotherapy.~   "
139850|NCT01736826|"~     The primary objective of this study is to demonstrate that plasma concentrations of~     nucleosomes and free DNA differ between three groups:~        1. pregnant patients with complications typical of placental insufficiency or venous~          thrombosis (group P),~        2. healthy women (Group T1) and~        3. healthy pregnant women (Group T2).~   "
139815|NCT01737281|"~     Veterans with a mental health diagnosis have higher a prevalence of smoking and higher rates~     of smoking-related morbidities compared to the general Veteran population. Smoking cessation~     treatment delivery in the VA typically depends on a visit from a health care provider. In~     this study, investigators will use information within the electronic medical record to~     identify all smokers with a mental health diagnosis at a VA health care facility and~     proactively reach out to enroll them in an intensive tobacco cessation treatment program.~     This approach could be generalized to other behaviors and provides a novel method to improve~     the health of an entire population of patients.~   "
139816|NCT01737268|"~     FK949E was administered to elderly bipolar disorder patients with major depressive episode~     for 52 weeks. Its safety, efficacy, and plasma concentration change were evaluated in an~     open-label manner.~   "
139817|NCT01737255|"~     This study is aimed at exploring the use of whole body MRI for early cancer detection in TP53~     mutation carriers and population controls, with the hypothesis that more cancers will be~     detected in the TP53 mutation carrier group. A secondary end-point will be the number of~     incidental findings detected and subsequent investigations required. A series of~     questionnaires will be used to assess the psychological impact of screening on both the study~     and control group.~   "
139818|NCT01737242|"~     The UKGPCS was set up to find genetic alterations which occur in patients who have prostate~     cancer.~      A man's risk of developing prostate cancer increases if he has a first-degree relative~     (father or brother) who was diagnosed with prostate cancer at a young age. This is why we are~     looking for men who are affected at a young age or who have a family history of prostate~     cancer, since it is more probable that these prostate cancers are due to an inherited genetic~     cause rather than an environmental cause.~      We also ask all men who come to the Royal Marsden Hospital to be treated for prostate cancer~     if they would like to take part in the study so that we can also look to see if we find~     genetic alterations in older men, and those who do not have a family history of prostate~     cancer.~   "
139819|NCT01737229|"~     TRIAL TITLE Open trial, not randomized study evaluating the efficacy and the tolerance of~     RD94 in patients needing endodontic care, medical device class III.~      SPONSOR:~      SEPTODONT, 58 rue de Pont de Créteil, 94107 Saint Maur des Fossés cedex Tel : + 33~     1-49-76-74-26, Fax. : + 33 1- 49-76-71-91~      Reference protocol: 09/001~      PRODUCT NAME: Biodentine™ (RD94)~      MEDICAL DEVICE:~      Class: Bioactive dental substitute (Tricalcium silicate) Dose: not applicable Application :~     one single time~      DEVELOPMENTAL PHASE: not applicable (medical device class III)~   "
139820|NCT01737216|"~     Pilot study of Zoledronic acid in combination with first-line chemotherapy in aged patients~     with lung cancer. The purpose is to assess the effects of Zoledronic acid in combination with~     first-line chemotherapy in aged patients with lung cancer on bone mineral density gain in the~     lumbar spine and total hip.~   "
139821|NCT01737203|"~     The purpose of this study is to assess the bioequivalence of Sildenafil ODT 50 mg without~     water to Japanese commercial oral tablet of sildenafil citrate (Viagra® tablet) 50 mg under~     fasted conditions.~   "
139822|NCT01737190|"~     The aim of the study is to examine the effects of two different levels of PEEP on subsequent~     standard recruitment maneuver.~   "
139823|NCT01737177|"~     This is a prospective, multicenter phase II trial designed to evaluate the safety and~     activity of the combination of Bendamustine, Lenalidomide and Rituximab (R2-B) in patients~     with first relapsed/refractory mantle cell lymphoma (MCL) and the efficacy and safety of a~     maintenance treatment with Lenalidomide for 18 months from the end of R2-B (from month 7 to~     24) for those responding to the induction.~   "
139824|NCT01737164|"~     Aging is a major risk factor for the development of type 2 diabetes (T2DM). Approximately 50%~     of subjects aged ≥65 have diabetes or impaired glucose tolerance, a pre-diabetic state.~     Purpose: In the proposed study, the investigators will test the hypotheses that the decrease~     in fat oxidation that occurs in muscle from older human subjects is secondary to an~     age-mediated reduction in AMPK signaling, in vivo, and that upregulating AMPK signaling~     through exercise training will result in (and correlate with) increased fat oxidation,~     reduced intramyocellular lipids, and improved insulin action.~   "
139825|NCT01737151|"~     This clinical trial studies stereotactic body radiation therapy in treating patients with~     low- and intermediate-risk prostate cancer. Stereotactic body radiation therapy may be able~     to send x-rays directly to the tumor and cause less damage to normal tissue.~   "
139826|NCT01737138|"~     To study whether renal sympathetic denervation(RSD) is safe and effective in patients with~     chronic kidney disease and resistant hypertension~   "
139827|NCT01737125|"~     The distal tibio-fibular joint ( DTFJ) be an integral part of the ankle and its injury makes~     all the gravity, forecast and complexity of ankle fracture treatment. It's classically~     described and known by radiological point of view, but in static incidence and from~     anatomical studies. To our knowledge the dynamic dimension and its modelling is missing. Our~     study will use high spatial-resolution MRI acquisition to obtain the best possible definition~     of DTFJ but especially it will be associated with MRI acquisition in movement, using typical~     fast sequences  TrueFISP  and FLASH which will allow a precise modelling of joint~     physiological movements and biomechanics on healthy subjects by a not invasive method. This~     analysis will be made on a simple movement of flexion and extension, the other possible~     movements of the ankle being blocked what corresponds to the clinical situation of an~     osteosynthesis ankle immobilized in post-operative by a dynamic rehabilitation shoe Axmed ®~     It will be associated aneffort test  with the reproduction of subjected joint of a load~     with MRI joint movement control This test will be made with an ankle fixed to 90 ° of flexion~     what reproduces the post-operative clinical situationThe meditative data will be associated~     with an anatomical biomechanical study of ankles presenting a syndesmosis injury repaired~     according to the classic protocol using in our department, by comparing them with the data of~     the literature to optimize techniques repair of this joint. Indeed there is not gold standard~     surgical technique Main PurposeTo understand, observe, analyze and quantify the joint~     movement during a simple movement of ankle extension and flexion, and during a simulation of~     axial load miming walk fixed to 90 ° as in post-operative. Secondary purpose - Modelling the~     DTFJ- Modify the post-operative care with hypothesis that load does not lead abnormal~     movement in DTFJ with an ankle fixed to 90 ° ( post-operative clinical condition). - Validate~     our technique of repair of this joint by comparing the data MRI with anatomical mechanical~     tests~   "
139828|NCT01737112|"~     This is an open-label SPECT/CT (single photon emission computed tomography / computed~     tomography) study to investigate the safety and diagnostic performance of 99mTc-3PRGD2 in~     evaluation of lung cancer patients. A single dose of nearly 11.1 MBq/kg body weight of~     99mTc-3PRGD2 ( ≤ 20 µg 3PRGD2) will be intravenously injected into the patients in suspicion~     of lung cancer. Visual and semiquantitative method will be used to assess the whole-body~     planar and thoracic SPECT/CT images. Any adverse events will be collected from the patients.~   "
139829|NCT01737099|"~     The purpose of this study is to investigate the efficacy and safety of DHA-O to lower~     elevated triglyceride levels in healthy adults with hypertriglyceridemia.~   "
139830|NCT01737086|"~     Oral rehydration solution (ORS) is recommended for treatment and prevention of dehydration~     due to acute gastroenteritis in infants and children. Acute diarrhoea leads to zinc depletion~     in infants, and zinc is recommended by the World Health Organization in the treatment of~     acute gastroenteritis in infants and children. However, the efficacy of zinc supplementation~     to children with acute gastroenteritis in more affluent settings is unclear. Selected strains~     of probiotics, including L. reuteri ATCC 55730, have been shown in several studies to shorten~     the duration of diarrhoea by about 24 hours, and also to attenuate symptom severity. If~     probiotics are given within 60 hours from onset of symptoms the duration can be reduced even~     more. Lactobacillus reuteri (L. reuteri) has been shown to reduce the duration and severity~     of acute gastroenteritis in children aged 6-36 months. In these studies L. reuteri was proven~     to have clinical effect on diarrhoea of both bacterial and viral (rotavirus) origin. In~     humans, L. reuteri strain DSM 17938 has recently been shown to reduce the duration of watery~     diarrhoea by 1.2 days among 6-36 mo old Italian children with acute gastroenteritis treated~     in hospital.~      The present, community-based study aims to assess if an ORS with Lactobacillus reuteri DSM~     17938 and zinc can be superior or equivalent to ORS without probiotic and zinc in reducing~     the duration of acute gastroenteritis in children aged 6-36 months, with no, mild or moderate~     dehydration when introduced early (within 48 hours) after the start of gastroenteritis~     associated diarrhoea in an out-patient setting.~      A prospective, randomized, double blind, controlled study with parallel groups will be~     performed. Assuming a difference of 25% between groups in the primary outcome of prevalence~     of diarrhoea 48 hours after start of treatment (80% power, alfa = 5%), and estimating an~     attrition rate of approximately 15%, the final sample size will be 142 subjects, or 71~     subjects in each arm.~      Parents contacting the health care telephone enquiry agency, the primary care emergency unit,~     the paediatric emergency unit, all at the Umeå University Hospital or the well-baby care~     centres (BVC) in Umeå for advice on their children's gastroenteritis will be informed that~     they may participate in the present study and they will be given contact information to the~     research nurse for this activity. A home visit by study personnel will then be done for~     evaluation of eligibility, information, collection of informed consent and delivery of study~     product.~      Data collection points will be at the recruitment visit in the patient's home, and by~     telephone on day 7. If the child still has gastrointestinal symptoms on day 5 it will be~     referred to the primary health care facility or the outpatient clinic of the Department of~     Paediatrics, Umeå University Hospital.~   "
139831|NCT01737073|"~     This study will enroll Veterans with chronic pain who have been receiving opioid medications~     (like methadone, percocet, oxycontin) on a regular basis for at least 3 months to treat their~     pain. The purpose of this study is to understand if two automated interventions that are~     delivered by phone can improve the safe and effective use of opioid medications and the~     physical functioning of Veterans with chronic pain who take opioid medications. One~     intervention, opioid monitoring, will include monthly automated calls to the enrolled Veteran~     to ask questions about their use of the opioid medications, pain relief, side effects, effect~     of pain on physical activity and mood and satisfaction with pain care. The other~     intervention, skills training, includes learning pain management skills using automated calls~     and a self-help book with weekly feedback calls from a nurse. Veterans who are enrolled in~     this study will be randomly assigned (by chance, like a flip of a coin) to receive either~     opioid monitoring only, self-management only, self-management plus opioid monitoring or a~     weekly automated phone call with wellness tips. Everyone enrolled in the study will complete~     questionnaires about their pain and other pain-related information at the beginning of the~     trial, after the interventions are completed 12 weeks later, and 3 and 6 months after~     treatment ends.~   "
139832|NCT01737060|"~     To investigate the assumption that reversed shoulder prosthetic replacement will give a~     better functional outcome compared to open reduction and internal fixation with an angular~     stable plate in displaced proximal humeral fractures.~   "
139833|NCT01737047|"~     The purpose of this study is to identify medical conditions that may cause particular~     problems to individuals receiving care for HIV infection over the age of 50. In addition, as~     the effects and potentially the side effects, of HIV medication may change with age, this~     study will also investigate the association between age and differing effects of~     antiretroviral therapies such as treatment outcomes, side effects and the levels of drugs in~     blood.~      Results from this study may inform future HIV treatment guidelines on how we monitor~     individuals with HIV infection. The results may also assist in the design of future studies~     for the treatment of diseases associated with ageing.~   "
139834|NCT01737034|"~     The catch-up fat phenomenon is an evolutionary conserved physiological response to a~     starvationrefeeding cycle. It is characterized by long-term suppression of thermogenesis,~     reduced body protein regain and an increase in fat mass above basal level during refeeding.~     Clinically, it characterises weight cycling in overweight patients which is associated with~     increasing fat mass (visceral fat) and increased morbidity (e.g. insulin resistance,~     inflammation). In this project, the physiological, cellular and molecular mechanisms of this~     phenomenon will be investigated in humans, mice and C. elegans. It is hypothesized that~     refeeding a low GI (=glycemic index)- diet after weight loss prevents the catchup fat~     phenomenon and its sequelae. This translational research will provide comprehensive insights~     into the catch-up fat phenomenon as well as provide a suitable strategy of its prevention.~   "
139835|NCT01737021|"~     1. Evaluate the feasibility and acceptability of an information based intervention~          delivered to parents following their child's admission to paediatric intensive care;~        2. Evaluate the feasibility and acceptability of the study design and procedures;~        3. Explore the effects of the intervention on parent and child psychological outcomes 3-6~          months post discharge from PICU;~        4. Explore the effects of parental stress experienced during PICU admission on the~          effectiveness of the intervention;~        5. To provide data that, combined with results from other studies, could inform the sample~          size for a future multi-site RCT.~   "
139836|NCT01737008|"~     This is a phase 1 study of the drug dacomitinib with radiotherapy, with or without~     chemotherapy, in patients with advanced squamous cell carcinoma of the head and neck (SCCHN).~      Dacomitinib is an oral drug, which is found to be active in SCCHN patients, blocks a receptor~     called the epidermal growth factor receptor (EGFR). By blocking signals for cancer cells to~     grow, it is believed to stop or slow the growth of tumor cells.~      The dose escalation phase will find the best dose as well as determine the safety of~     dacomitinib when given with radiotherapy and with or without chemotherapy.The dose expansion~     phase will further test the best dose determined in the dose escalation phase for response~     rate.~   "
139849|NCT01736839|"~     In cystic fibrosis, there is a critical need for better predictors of treatment response. The~     investigators have identified a panel of white blood cell biomarkers which can be directly~     measured as a blood test in subjects with cystic fibrosis. These biomarkers predict reduction~     of airway inflammation and infection more accurately than lung function testing, in patients~     receiving intravenous antibiotic therapy. In the current study, we hypothesize that this~     panel of gene biomarkers which can be readily measured from peripheral blood will sensitively~     predict changes in inflammation when patients receive inhaled antibiotic therapy,~     specifically Cayston (or inhaled aztreonam lysine). Patients enrolled in the study will have~     blood drawn before and after a month of inhaled Cayston, in order to test whether genes~     predict response to Cayston therapy more robustly than do standard measures such as lung~     function tests.~   "
139837|NCT01736995|"~     Research has provided support for the efficacy of cognitive-behavioral and family~     interventions for adolescent substance use disorders (SUD), HIV-risk behaviors, and related~     problems. Despite support for these interventions, substantial heterogeneity in treatment~     outcomes and high relapse rates has been consistently found across studies. Such variability~     highlights the need for innovative strategies to broaden the impact and strengthen the~     durability of effects of adolescent substance abuse treatments. Over the past two decades,~     research has shown the positive effects of contingency management (CM) methods on reductions~     in substance use and other problem behaviors. When combined with evidence-based practices,~     emerging research suggests that CM integration may also be effective for adolescent substance~     abusers. The proposed Stage II efficacy trial examines the integration of CM with two~     empirically-supported interventions: group MET/CBT and FFT. By comparing two intervention~     modalities (group vs. family, the study provides a unique opportunity to examine the~     robustness of the effects of CM across established adolescent treatments, and to compare~     change mechanisms that may account for treatment outcomes. In the proposed research,~     substance abusing adolescents (n = 160) will be randomly assigned either to FFT or group~     MET/CBT. Random assignment will also be used to determine whether or not youth will receive a~     CM condition that provides incentives for abstinence (i.e., clean urine screens) and~     treatment participation. The primary aim of the study is to examine the efficacy of an~     integrated CM intervention for the two evidence-based treatments for adolescents, MET/CBT and~     FFT, compared to these treatments without CM on drug abuse abstinence (a) during treatment~     (i.e., speed of effects) and (b) at post-treatment follow-up assessments (i.e., durability of~     effects). A second aim of the study is to evaluate the effects of CM on hypothesized~     mediators of the intervention effects in the MET/CBT and the FFT conditions. The~     investigators anticipate that the CM conditions, compared to the nonCM conditions, are more~     likely to accelerate the adolescent's motivation (1) to achieve abstinence, to attend and~     participate in treatment, and to complete homework assignments. The investigators will also~     examine the effects of the interventions on HIV-risk behaviors and expect that CM will~     demonstrate the largest reductions in HIV-risk behaviors compared to the nonCM conditions.~   "
139838|NCT01736982|"~     Smoking cessation services are an unmet need among the homeless, who smoke at rates more than~     3 times the national estimate; successful interventions in this underserved population have~     the potential for improving individual and public health. Contingency management (CM) is a~     behavioral intervention with efficacy in a number of substance use disorder populations,~     including smokers. However, no known studies have evaluated the effect of CM in homeless~     smokers. The investigators plan to examine smoking-related outcomes in homeless~     treatment-seeking smokers (N = 70) randomized to standard care smoking cessation (transdermal~     nicotine replacement therapy [NRT] + standard counseling + carbon monoxide [CO] monitoring)~     or standard care plus CM (NRT + standard counseling + CO monitoring + CM) conditions.~     Standard counseling and CO monitoring will occur for the first 4 weeks, with NRT use~     continuing through week 8. Participants in both conditions will meet with study staff up to~     twice daily on weekdays for biochemical verification of smoking status. Participants in the~     CM condition will have the opportunity to earn prizes for negative breath samples (CO ≤ 4~     ppm) up to twice daily on weekdays. CO breath samples will be collected at all visits. The~     investigators expect that participants randomized to CM will have better outcomes compared to~     those in standard care.~   "
139839|NCT01736969|"~     The purpose of this study is to determine whether a developmental formulation is~     substantially equivalent to the predicate device in the treatment of hypertrophic and keloid~     scars.~   "
139840|NCT01736956|"~     For fetuses with severe aortic stenosis, in utero balloon aortic valvuloplasty may improve~     fetal growth of left heart structures and thus improve potential for biventricular repair~     strategies after birth.~   "
139841|NCT01736943|"~     The purpose of this study is to determine whether bortezomib in combination with~     doxil/lipodox is effective in the treatment of Acute Myeloid Leukemia.~   "
139842|NCT01736930|"~     The purpose of this study is to evaluate an overnight system that will turn off the insulin~     pump automatically if the system predicts that a low blood sugar is likely. The study system~     includes a combination continuous glucose monitor (CGM)/ insulin pump made by Medtronic~     MiniMed, Inc and a regular laptop computer that runs a computer program that predicts low~     blood sugar. It works by (1) measuring the glucose levels under the skin with a continuous~     glucose monitor, (2) using a computer program on a laptop to predict what will happen to the~     glucose level over the next 35-55 minutes, and (3) turning off the insulin pump when the~     computer program predicts that low blood sugar will occur. We have tested this system~     overnight in the hospital and are ready to test the system in the home environment to learn~     more about how well it will work and to make sure that the blood sugar does not go too high~     when the pump shuts off.~      This study has several phases and will take about a month or a little more for a patient to~     complete. Patients will use the study system for about 5 days at home to show that the~     patient is able to use it correctly. After that, the patient will be asked to use the study~     system each night for an additional 3-4 weeks. During this time, the system will be active~     for two-thirds of the nights and not active for one-third of the nights. When the system is~     active and predicts that your blood sugar will become low, the insulin pump will shut off for~     up to 2 hours.~      The study will include 2 clinical centers in the United States.~   "
139843|NCT01736917|"~     The hypothesis is that the substitution of multi-day oral aprepitant with (intravenous) IV~     fosaprepitant, in combination with a 5-HT3 receptor antagonists (5HT3RA) + dexamethasone will~     provide comparable protection from 5 day cisplatin chemotherapy induced nausea and vomiting,~     compared to the results of our prior study of aprepitant. This study will be the first~     clinical trial evaluating fosaprepitant in patients receiving multi-day cisplatin. This will~     be a single arm, phase II study. The investigators propose to utilize intravenous (IV)~     fosaprepitant on days 3 and 5 of the 5-day cisplatin chemotherapy regimen. It is anticipated~     that fosaprepitant can suppress delayed chemo-induced nausea and vomiting for 2-5 days after~     therapy. This study will test the value of fosaprepitant in this patient population.~   "
139844|NCT01736904|"~     The aim of this study is to compare weekly-XELIRI(wXELIRI) regimen versus FOLFIRI regimen in~     the treatment of advanced colorectal cancer patients. The hypothesis is the efficacy of~     wXELIRI is not less than FOLFIRI with tolerable toxicity.~   "
139845|NCT01736891|"~     The objective of this study is to evaluate the efficacy, tolerability, and safety of~     rasagiline compared to placebo in PD patients with motor fluctuations on levodopa therapy.~   "
139846|NCT01736878|"~     The purpose of his study is to evaluate the efficacy and safety of Sorafenib versus placebo~     in subjects with locally advanced medullary thyroid cancer (MTC). The primary study objective~     is to compare the Progression-free Survival (PFS) of the Sorafenib treatment group with the~     placebo treatment group in patients with advanced MTC.~   "
139847|NCT01736865|"~     This research study in adults with established type 2 diabetes will test whether daily~     vitamin D supplementation affects how the body processes glucose (sugar).~   "
139848|NCT01736852|"~     The CRB study is designed to study the safety and effectiveness of the Cook Cervical Ripening~     Balloon (CRB) for the induction of labor in term and near-term patients with premature~     rupture of membranes (PROM).~   "
139851|NCT01736813|"~     The surface molecule CCR5 is found on tumor cells within liver metastases of colorectal~     cancer. Inhibition of this molecule leads to a reduction in growth signals for tumor cells~     and subsequent slowed or halted tumor growth. The agent for the inhibition of CCR5 has~     already received FDA approval for treatment of HIV and has shown little side effects and~     toxicities even on long term treatment. Therefore CCR5-inhibition has the potential of~     providing non-toxic tumor growth inhibition.~   "
139852|NCT01736800|"~     The specific purpose of this study is to obtain data on safety and efficacy of combination~     chemotherapy with Temozolomide and Topotecan in patients with CNS metastases of solid tumors.~     Up to 35 patients will be accrued over 2-3 years and followed for up to 5 years and will~     receive 8 cycles of chemotherapy. The primary endpoint is the determinant median overall~     survival and progression-free survival of this regimen, time to progression of the brain~     metastases, and assessment of toxicity levels in this regimen.~   "
139853|NCT01736787|"~     The investigators performed a 12-week, randomized, double-blind, placebo-controlled human~     trial to evaluate the efficacy and safety of Cauliflower Mushroom extract on promotion of~     immunity. The investigators measured promotion of immunity parameters , including~     Cytotoxicity, Cytokine (IL-4, IL-10, IFN- γ, TNF-α), and CBC (WBC, RBC, Hb, Hct, MCV, MCH,~     MCHC, PLT), and monitored their blood pressure.~   "
139854|NCT01736774|"~     The presence of cervical musculoskeletal impairment is not specific to cervicogenic headache~     but other various frequent intermittent headache types (i.e. migraine and tension-type~     headache) in the elderly population. There has been no trial to date which has investigated~     the effectiveness of physiotherapy treatment specifically for older persons with various~     types of headache with associated neck pain and cervical musculoskeletal impairment. Thus,~     the purpose of study investigate the efficacy of physiotherapy treatment for older persons~     who have headache concomitant with neck pain and musculoskeletal impairment~   "
139855|NCT01736761|"~     For patients who are starting to take antiretroviral medication (to treat HIV) for the first~     time, there are now a variety of different medicines which may be taken together as a~     combination in order to form an effective treatment which suppresses the virus for prolonged~     periods of time. Currently, national guidelines recommend the use of two different drugs of~     one type (the nucleoside/ nucleotide reverse transcriptase inhibitors, NRTI often known as~     nukes) with a third drug from one of two other types (either a nonnucleoside reverse~     transcriptase inhibitor, known as an NNRTI or nonnuke, or a protease inhibitor, known as a~     PI) to form a treatment regime of three active drugs. In the UK and Europe, all PIs are given~     in combination with a small dose of a second PI, ritonavir, which has the effect of boosting~     the levels of the active PI in the bloodstream.~      The investigators know from both research studies and patient experience in clinic that a~     combination of a ritonavirboosted PI with an NNRTI achieves similar results in suppressing~     the HIV virus, compared to the use of either a PI or NNRTI with 2 NRTI as described above. In~     this study, the investigators will observe the combination of two licensed antiretroviral~     medications, ritonavirboosted darunavir(DRV/r) and rilpivirine (RPV), in suppressing virus~     when given to patients who are commencing treatment for HIV infection for the first time.~     Both of these drugs are licensed for treatment of patients with HIV in the UK and Europe, and~     are currently in standard clinical use.~      The study will monitor this treatment over the first 48 weeks. The investigators will also~     examine the levels of both drugs in the bloodstream during the first 4 weeks of starting this~     regimen, to confirm that they remain at levels which the investigators know to be effective~     against the virus.~   "
139856|NCT01736748|"~     The Dyn@mo lifestyle intervention (CHU Sainte-Justine, Quebec, Canada) targets children and~     adolescents aged 6 to 17 years old with cardiometabolic risk factors, such as obesity,~     hypertension, disorders in glucose regulation or dyslipidemia. Its primary goal is to promote~     physical activity and reduce sedentary time to improve childrens' cardiometabolic profile. To~     do so, the intervention relies on gathering data on mobility and physical activity using~     wearable sensors. These data provide a detailed picture of real-life conditions and physical~     activity levels, improving the health care professional's ability to tailor counseling. The~     investigators are presently in the implementation phase of this intervention.~   "
139857|NCT01736735|"~     This is a placebo-controlled study to determine the effect of CLP in heart failure subjects~     with fluid overload.~   "
139858|NCT01736722|"~     The Methodist Hospital Neurological Institute is conducting a clinical trial for patients~     suffering from Metastatic brain tumors. The objective for this study is to evaluate the~     safety and feasibility of a MRI-guided laser thermal therapy during a real-time MRI guidance~     for the treatment of brain metastasis.~      Patient will undergo laser therapy using the MRI scan to plan the treatment and ensure proper~     placement of the laser within the tumor. The tumor will then be heated by the laser and~     monitored by study physicians through the real-time MRI to see and control temperatures in~     the tissue. One in place, the thermal laser will then surgically remove the lesions. After~     the procedure, post treatment MR images will thenbe acquired for the determination of the~     effective treatment region.~   "
139859|NCT01736709|"~     The purpose of this study is to evaluate the immunogenicity and safety of 2012-2013 trivalent~     seasonal influenza vaccine in 60 healthy infants aged 6-35 months old, 60 healthy adults aged~     18-60 years old, and 60 healthy older people aged > 60 years.~   "
139860|NCT01736696|"~     This study was conducted in subjects with psoriasis to evaluate drug activity in this patient~     population by analysis of changes in psoriatic lesion biopsy characteristics. This subject~     population was selected to evaluate potentially relevant biological activity of CP-690,550 as~     well as assessing safety and pharmacokinetics.~   "
139861|NCT01736683|"~     The primary objective of this study is to determine a safe, tolerable and effective dose of~     sotatercept that results in the greatest frequency of improvement of anemia in patients~     diagnosed with low- or intermediate-1 risk MDS or non-proliferative chronic myelomonocytic~     leukemia (CMML).~   "
139893|NCT01736267|"~     The purpose of this research study is to determine whether Auditory Brainstem Implant (ABI)~     can improve hearing in persons who are deaf in both ears and are not candidates for cochlear~     implants.~   "
139933|NCT01735747|"~     In this trial, we will treat newly diagnosed PCNSL with temozolomide, nedaplatin, vincristine~     (TNV) as the replacement of high-dose methotrexate to combine with concurrent~     chemoradiotherapy. Our objective was to assess our treatment strategies' availability based~     on response rates, progression-free survival (PFS), median PFS, and toxicity.~   "
139862|NCT01736670|"~     Triamcinolone acetonide is a mid-potency, class 4/5 topical corticosteroid that is available~     in a spray formulation (Triamcinolone Acetonide Spray, T Spray). It is indicated for the~     relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.~     Unlike more potent steroid products, T Spray has no time limitations on its use; therefore,~     it is commonly used to treat flares in psoriasis, atopic dermatitis, seborrheic dermatitis,~     and contact dermatitis.~      In contrast to creams and ointments, T Spray can easily cover large and hard-to-reach areas~     of the body. Its optional nozzle directs application of the medication to precise areas~     without affecting nearby areas. Patients requiring a mid-potency corticosteroid for lesions~     on the scalp, back, intertriginous folds, large areas, or areas that require precise~     application would benefit from the T Spray formulation. In the time since the introduction of~     T Spray to dermatology, other topical corticosteroids have entered the market, but T Spray~     remains the only mid-potency corticosteroid available in a spray formulation.~      In a recently published open-label, non-comparator study involving 42 patients with chronic~     steroid-responsive dermatoses, T Spray was used up to four times a day for 28 days.~     Improvement of lesions after one week of treatment was experienced by 85% of patients, and~     95% of subjects preferred the spray over creams and ointment. Most importantly, 56% of~     patients reported an anti-pruritic cooling effect which was experienced upon application.~   "
139863|NCT01736657|"~     The purpose of this study is to evaluate the performance of the Spectra Optia system red~     blood cell exchange (RBCx) protocols (exchange and depletion/exchange) in study participants~     with sickle cell disease.~   "
139864|NCT01736644|"~     This study will compare the clinical outcomes for patients undergoing a total knee~     replacement using a bipolar sealer, the Aquamantys® System, as compared to standard~     electrocautery. Total blood loss during the hospital stay and knee mobility and discharge~     factors will be analyzed.~   "
139865|NCT01736631|"~     We are doing this study to find out how well cognitive behavioural therapy for social phobia~     works in people with bipolar disorder, who also have social phobia.~   "
139866|NCT01736618|"~     The purpose of the S-ICD Post Approval Study is to document long term safety and~     effectiveness outcomes associated with the implantation of the SQ-RX pulse generator and~     Q-TRAK electrode in a commercial clinical setting.~   "
139867|NCT01736605|"~     In this study we propose to explore the efficacy of massage therapy combined with meditation~     in women recovering from tissue reconstruction after mastectomy for breast cancer. Patients~     will be randomized into 2 groups. The first group will consist of massage therapy on 3~     consecutive days starting on the 1st day after surgery. The second group will consist of~     massage therapy combined with meditation for 3 consecutive days starting on the 1st day after~     surgery. The effect of massage and massage combined with meditation on stress, anxiety,~     relaxation, insomnia, alertness, fatigue, tension/muscular discomfort, pain, mood and energy~     level will be evaluated by using three different surveys.~   "
139868|NCT01736592|"~     Primary Objective:~      To evaluate the long-term safety and tolerability of SAR422459 in patients with Stargardt's~     Macular Degeneration.~      Secondary Objective:~      To assess:~        -  Safety~        -  Biological activity~   "
139869|NCT01736579|"~     The purpose of this long-term study is to provide additional evidence of safety and efficacy~     of IGIV, 10% treatment in participants with Alzheimer´s Disease who have completed the Phase~     3 Baxter precursor study 160701. All participants will receive IGIV, 10% at either 0.2 g/kg~     or 0.4 g/kg body weight depending on their treatment assignment in Baxter study 160701.~     Participants and investigators will be blinded to dose unless otherwise notified by the~     sponsor.~   "
139870|NCT01736566|"~     The MedSeq™ Project seeks to explore the impact of incorporating information from a patient's~     whole genome sequence into the practice of clinical medicine. In the extension phase of~     MedSeq we are attempting increase our participant diversity by increasing targeted enrollment~     of African/African American patient participants.~   "
139871|NCT01736553|"~     Spinal muscular atrophy (SMA) is the leading genetic cause of death of infants. Strong~     preclinical evidence suggests that effective therapy must be delivered as early as possible~     to prevent progression of the disease. The primary study objective will be to identify~     prognostic and surrogate biomarkers of disease progression that will facilitate the execution~     of therapeutic SMA clinical trials in infants.~   "
139872|NCT01736540|"~     Iron, one of the most common elements in nature and the most abundant transition metal in the~     body, is readily capable of accepting and donating electrons. This capability makes iron a~     useful component of various, essential biochemical processes. Despite the essential role of~     iron, the excess of iron is toxic to the human body. It is critical for the human body to~     maintain iron balance, since humans have no physiologic mechanism for actively removing iron~     from the body.~      The development of iron overload occurs when iron intake exceeds the body's capacity to~     safely store the iron in the liver, which is the primary store for iron. Long-term~     transfusion therapy, a life-giving treatment for patients with intractable chronic anemia is~     currently the most frequent cause of secondary iron overload.~      The mounting evidence regarding the mortality and morbidity due to chronic iron overload in~     transfusion dependent anaemias has led to the establishment of guidelines that aim the~     improvement of patient outcomes. Further prospective studies are warranted in order to assess~     the impact of iron overload in patients with acquired anaemias.~      In this study, non-invasive R2- and T2*-MRI techniques were applied to the liver and the~     heart, respectively, to complement the primary variable (serum ferritin) assessed in patients~     with various transfusion-dependent anaemias. The main objective of this study was to assess~     the prevalence and severity of cardiac and liver siderosis in patients with transfusional~     siderosis. This study was also aim to establish possible correlations between cardiac and~     liver iron levels with clinical effects in patients with different transfusion-dependent~     anaemias. Patients were eligible for enrollment irrespective of receiving chelation therapy~     or not (and irrespective of the chelating agent used).~   "
139873|NCT01736527|"~     To assess the levels of loteprednol etabonate (LE) in tear fluid following a single topical~     instillation of LE ophthalmic gel 0.5% formulation to healthy volunteers.~   "
139874|NCT01736514|"~     This is a multicenter, open label, randomized, allopurinol-controlled, parallel-design study.~     Approximately 120 subjects will be randomly assigned in 1:1 ratio to receive febuxostat, or~     allopurinol for subjects with gout.~   "
139875|NCT01736501|"~     A 10 minute baseline survey will be administered to parents of healthy newborn infants while~     in the hospital after delivery at Brigham and Women's Hospital, to be followed by a 25 minute~     survey 3-24 months later. We will measure parents' attitudes and preferences related to~     genome screening of newborns. The specific aims of this study are:~        1. To investigate whether parents' opinions regarding genome screening of newborns change~          between the first 48 hours post-partum and 3-24 months post-partum.~           a. We hypothesize that there will not be significant differences between interest in~          genome screening results in the 48 hours post-partum compared to 3-24 months~          post-partum.~        2. To determine whether seeing hypothetical genome screening results affects parents'~          decisions regarding whether they would want genome screening for their newborn.~             1. We expect many parents to state initially (in the 48 hours post-partum) that they~               would elect to have genome screening for their newborn if it were available. In the~               follow-up survey, half of study participants will receive hypothetical scenarios in~               which they will need to struggle with the probabilistic and ambiguous nature of the~               information that could be derived from genome sequencing. We will examine whether~               this alters their preferences. We will also explore whether parents who receive~               hypothetical genome screening results scenarios are more likely to alter their~               preferences than parents who do not receive hypothetical scenarios.~   "
139876|NCT01736488|"~     The purpose of this study is to evaluate the antihypertensive efficacy and changes of~     neurohormonal markers of fimasartan and atenolol with exaggerated blood pressure response~     during exercise in essential hypertensive patients.~   "
139877|NCT01736475|"~     To assess efficacy and safety, including immunogenicity of BAX 855 administered as~     prophylaxis and as on-demand therapy in adult and adolescent (12-65 years) previously treated~     patients (PTPs) with severe hemophilia A To determine the pharmacokinetic (PK) parameters of~     BAX 855.~   "
139878|NCT01736462|"~     The objective of this study is to evaluate the effect on corneal endothelial cell density~     (cells/mm²) changes at 3 months when mapracorat ophthalmic suspension, 3% is administered QID~     (four times daily), for 14 days in healthy subjects with a normal ophthalmic history.~   "
139879|NCT01736449|"~     A pterygium is a fibrovascular growth originating from the conjunctiva that grows onto the~     surface of the cornea. Frequently, these pterygia will recur even after surgical resection.~     Bevacizumab is an inhibitor of angiogenesis, which is needed for recurrent growth. The use of~     bevacizumab is poorly understood in inhibiting pterygium growth. The objective of this study~     is to compare the effects of wound healing and recurrence rates in postoperative bevacizumab~     versus pterygium excision alone.~   "
139880|NCT01736436|"~     It has been shown in preclinical experiments with bone marrow from patients with~     myelodysplastic syndrome that APG101 rescues erythrocytes from premature cell death. This is~     expected to translate in an improved erythropoiesis and ameliorated anemia in MDS patients.~      APG101 might, therefore, be a valuable addition to current treatments of low- or intermediate~     MDS patients suffering from anaemia.~      Transfusion-dependent patients with low or intermediate risk MDS according to WHO Prognostic~     Scoring Scale (WPSS) can be included in this study.~      Treatment consists of 100mg APG101 intravenous as a weekly treatment over 12 weeks + 6 months~     follow up phase.~      Primary objective of the trial is safety and tolerability of APG101; secondary objectives are~        -  Hematologic, cytologic and cytogenetic response rate using modified International~          Working Group (IWG) response criteria~        -  Incidence and time to leukemic progression at 37 weeks~        -  OS (Overall survival) at 37 weeks~   "
139881|NCT01736423|"~     To evaluate the efficacy and safety of YM060 once daily for female patients with~     diarrhea-predominant irritable bowel syndrome (D-IBS) for a long-term period (up to 52~     weeks).~   "
139882|NCT01736410|"~     To explore overall response rate of trastuzumab combined with TS-ONE based chemotherapy in~     first-line HER2-positive advanced gastric cancer.~   "
139883|NCT01736397|"~     The purpose of this study is to determine if KRX-0502 (ferric citrate) is a safe and~     effective treatment for the management of serum phosphorus levels and iron deficiency in~     anemic chronic kidney disease (CKD) stage 3-5 subjects not on dialysis. Total length of~     treatment is approximately 12 weeks.~   "
139884|NCT01736384|"~     There is a variability in weight loss after gastric bypass surgery for obesity despite a~     standardised surgical procedure. This study aims to investigate if genetic markers can~     predict outcome after gastric by-pass surgery in treatment of obesity. The investigators will~     also study if adenovirus infection can influence the outcome after surgery. In a subgroup of~     patients, hormonal changes after gastric by-pass surgery will be assessed. Lipid and protein~     patterns will be assessed in plasma and tissues. Omental and subcutaneous fat as well as~     liver biopsies and whole blood are stored in a biobank. The same tissues will be collected~     from non-obese controls undergoing gallbladder surgery.~   "
139885|NCT01736371|"~     The aim in this study was to quantify the difference in cisatracurium and sufentanil~     consumption, and its recovery period, when patients are under balanced general anesthesia~     with 1% sevoflurane and patients under only sevoflurane general anesthesia, using a closed~     loop computer control infusion. Investigators further investigated this effect on its~     recovery period and sufentanyl consumption.~   "
139886|NCT01736358|"~     Despite an overall reduction in the perioperative complication rate, post operative pain~     management after ureteroscopic removal of stones (URS) remains a major factor delaying~     discharge of patients. The investigators hypothesize that perioperative usage of intranasal~     ketorolac will provide a reduction in post operative opioid requirements, better post~     operative pain control, higher anesthesia satisfaction and faster recovery.~   "
139887|NCT01736345|"~     The overall goal of the proposed research is to evaluate psychosocial and behavioral outcomes~     (i.e.risks and benefits) of an innovative and efficient delivery model for genetic testing,~     telephone communication, as an alternative to in-person communication of genetic testing~     results to inform guidelines regarding the delivery of genetic information in clinical~     medicine.~   "
139921|NCT01735903|"~     The purpose of this study is to measure the effect of nerve decompression on the recovery of~     the treated nerves. To obtain objective data during surgery of the treated nerves' via~     electrical signals and muscle power when stimulated. Also, to monitor muscle strength,~     balance/gait and blood flow in the lower extremity before and after surgery.~   "
139888|NCT01736332|"~     Background:~      - Some legal over-the-counter drugs (such as Vicks VapoInhaler ) and some foods (such as~     poppy seeds) may cause a positive screening drug test. This might look like someone used~     illegal drugs (such as methamphetamines or opiates) when they did not. Researchers are~     studying how the body handles chemicals that may test like illegal drugs and for how long~     they may be detected in the body. Blood, saliva, and urine samples will be collected. This~     study may help improve the effectiveness and accuracy of drug tests.~      Objectives:~      - To see how the body handles chemicals that may produce positive screening tests and how~     additional testing can eliminate positive drug tests from over-the-counter drugs and food.~      Eligibility:~      - Healthy volunteers between 18 and 65 years of age.~      Design:~        -  Participants are screened with a physical exam, medical history, laboratory tests, and~          ECG.~        -  This study involves an overnight stay on a secure research unit and 2 days of tests.~        -  On the first day, participants will take Vicks VapoInhaler (two inhalations in each~          nostril) every 2 hours from 9 a.m. to 7 p.m. They will also take a drink containing~          poppy seeds twice (at about 9 a.m. and 5 p.m.).~        -  On the morning of the second day, participants will take the Vicks VapoInhaler just~          once. They will be discharged around 5 p.m.~        -  On both days, participants will provide blood and saliva samples several times~          throughout the day. All of their urine will be collected during the 2 study days....~   "
139889|NCT01736319|"~     Background:~      - Artemisinin-based combination therapies (ACTs) are the first-line treatments for malaria.~     ACTs are highly effective, but malaria caused by the Plasmodium falciparum parasite is~     becoming resistant to some ACTs. ACT-resistant malaria has shown up in some parts of~     Cambodia, but not yet in other parts of the country. This has been shown by treating patients~     with ACTs, checking the amount of parasites in the patient s blood every 6 hours, and~     calculating the rate of parasite clearance. The parasite clearance rate in response to ACTs~     is getting slower in western Cambodia and may be the first sign of ACT resistance.~     Researchers want to study how effective ACTs are in different regions of Cambodia. This study~     will look at the extent of ACT resistance and how widespread ACT-resistant malaria has~     become.~      Objectives:~      - To compare the prevalence of ACT-resistant malaria in western, northern and eastern~     Cambodia.~      Eligibility:~      - Individuals between 2 and 65 years of age who have uncomplicated Plasmodium falciparum~     malaria and have not taken any antimalarial drugs for their symptoms in the previous 7 days.~      Design:~        -  Participants will be recruited from clinics and hospitals in three Cambodian provinces.~        -  Participants will be informed about the study and their consent to participate in the~          study will be obtained.~        -  A venous blood sample will be obtained from patients before treatment and used for~          laboratory experiments to measure parasite and patient factors that might affect the~          parasite clearance rate.~        -  Participants with malaria will be treated with dihydroartemisinin-piperaquine (DHA-PPQ),~          the standard first-line treatment for malaria in Cambodia.~        -  Treatment will be monitored with frequent blood samples obtained from a finger prick.~          The amount of malaria parasites in each blood sample will be counted and followed until~          they are no longer detectable.~        -  Participants will have weekly follow-up visits for up to 9 weeks. Finger-prick blood~          samples will be taken at each visit to see if the parasites reappear after treatment~          with ACT.~   "
139890|NCT01736306|"~     Background:~      - At present, women do not have very accurate tests to inform of them of their personal risk~     of developing breast cancer. More information on the changes associated with both benign and~     cancerous breast lesions will help develop better risk information. Researchers have been~     looking at cells found in breast milk to study genetic changes related to breast cancer.~     However, most of these cell samples have been collected from white women. A new study wants~     to collect breast milk samples from African American women for further research. Comparing~     the results of genetic tests will help improve understanding of breast cancer risk in all~     women.~      Objectives:~      - To study genetic changes related to breast lesions, including breast cancer, in African~     American women.~      Eligibility:~      - African American women at least 18 years of age who are nursing a baby and who either have~     had or are being considered for a breast biopsy.~      Design:~        -  Participants will be screened with personal health questions.~        -  Participants will receive a box with sterile bottles for milk collection. They will~          collect two breast milk samples, one from each breast. They will also fill out a~          questionnaire about their medical history.~        -  The box with the samples and the questionnaire will be returned to the clinical center~          for study.~        -  After the box is returned, participants will be asked to provide a copy of the biopsy~          report for any breast biopsies they have had.~        -  There will be a followup phone call every year. Participants will provide health history~          information. This information will include whether they have been diagnosed with breast~          cancer in the previous year.~   "
139891|NCT01736293|"~     Background:~      - The ABCA4 gene contains a blueprint for the ABCA4 protein. When this protein is absent or~     faulty (such as in Stargardt s disease), waste material from dead cells collects in the eye.~     The waste material may cause other cells in the eye to die. This can lead to the loss of~     vision. Researchers want to look at blood and skin samples from people with ABCA4 gene~     mutations to study related eye diseases.~      Objectives:~      - To study eye diseases that are related to mutations in the ABCA4 gene.~      Eligibility:~      - Individuals at least 12 years of age who have ABCA4 gene mutations.~      Design:~        -  The study requires seven visits to the National Eye Institute clinic over 5 years. In~          the first year, there will be three visits. After the first year, participants will have~          one visit a year for 4 more years.~        -  Participants will be screened with a physical exam, full eye exam, and medical history.~          The eye exam will check eye pressure, light and color sensitivity, and retina function.~        -  Participants will provide a blood sample and a skin tissue sample for study.~        -  No treatment will be provided as part of this study.~   "
139892|NCT01736280|"~     Background:~      - Some research studies focus on digestive disorders, such as nutritional, gastrointestinal,~     and liver disorders. Researchers want to examine and treat people with digestive disorders in~     order to learn more about these disorders. They also want to study how digestive disorders~     run in some families. To do so, they will provide standard care to people with digestive~     disorders. They will also look at relatives of people with digestive disorders, such as~     parents, children, and siblings.~      Objectives:~        -  To examine and treat people with digestive disorders.~        -  To evaluate people with digestive disorders for research studies.~      Eligibility:~        -  Individuals of any age who have digestive disorders.~        -  Individuals at least 2 years of age who are first-degree relatives of the people with~          digestive disorders.~      Design:~        -  Participants will have at least one outpatient visit to the National Institutes of~          Health. The visit will last about 2 hours.~        -  All participants will be screened with a physical exam and medical history. They will~          also provide different samples for study. Samples may include blood, urine, and stool~          samples. Saliva and hair samples may also be taken. Skin biopsies and rectal swabs may~          be collected from adult participants.~        -  Participants with digestive disorders may be able to receive treatment through this~          study.~   "
139894|NCT01736254|"~     The purpose of this study is to measure how much of the study drug (evacetrapib) gets into~     the blood stream and how long it takes the body to get rid of it when given with gemfibrozil.~     Each participant will receive gemfibrozil alone, evacetrapib alone, and both drugs in~     combination. There is no washout period between doses. The safety of both of the study drugs~     given together will be evaluated. Information about any side effects that may occur will also~     be collected. This study will last approximately 36 days.~   "
139895|NCT01736241|"~     The main purpose of this study is to evaluate the safety and tolerability of the study drug~     known as LY3053102 in healthy participants. The study will also investigate how much of the~     study drug gets into the blood stream and how long it takes the body to get rid of it.~     Information about any side effects that may occur will also be collected. The study is~     expected to last approximately 8 weeks for each participant (up to 4 weeks from the screening~     visit to the administration of study drug and an additional 4 weeks of follow up).~   "
139896|NCT01736228|"~     The purpose of this study is to establish the efficacy and safety of xenotransplantation of~     DIABECELL [immunoprotected (alginate-encapsulated) porcine islets] in patients with~     established type 1 diabetes mellitus~   "
139897|NCT01736215|"~     The purpose of this observational study is to evaluate the predictors of response to~     erythropoietin (hormone secreted by kidney that helps in formation of red blood cells in bone~     marrow) treatment in participants with cancer (abnormal tissue that grows and spreads in the~     body until it kills) related anemia (decreased number of red blood cells), receiving~     chemotherapy (treatment of cancer using drugs).~   "
139898|NCT01736202|"~     The development of type 2 diabetes is based on a combination of insulin resistance and beta~     cell dysfunction. In the last years, elevated FFA were recognized as a key players in the~     pathogenesis of insulin resistance and type 2 diabetes.~      The study compares the acute effects of an oral lipid bolus on insulin sensitivity and~     hepatic glucose metabolism in healthy humans.~   "
139899|NCT01736189|"~     In the usual clinical setting, patients with Rheumatoid Arthritis who receive adalimumab~     (Humira®) and high-dose Methotrexate (≥12 mg/week) will be investigated prospectively for~     effectiveness according to Disease Activity Score 28, modified Total Sharp Score, and other~     measures, as well as safety in terms of the incidence and pattern of occurrence of adverse~     drug reactions.~   "
139900|NCT01736176|"~     The primary objective of this study is to evaluate change in non-motor symptoms from baseline~     to Week 12 as measured by the Non-Motor Symptom Scale total score.~   "
139901|NCT01736163|"~     The study is to demonstrate non-inferior thyroid remnant first ablation success of Thyrogen~     and 131I compared to thyroid hormone withdrawal (THW) and 131I in patients with T4 tumour~     based on historical diagnostic whole body scan (DxWBS) records.~   "
139902|NCT01736150|"~     The study aims to evaluate the efficacy and safety of sevelamer carbonate in reducing serum~     phosphorus and serum lipids (total and LDL-cholesterol) in Chronic Kidney Disease Patients on~     dialysis.~   "
139903|NCT01736137|"~     The purpose of this study is to assess functional capacity, quality of life and functioning~     of the autonomic nervous system in heart failure patients on beta-blocker treatment. The~     study hypothesis is that subjects who walk less distance, have lower quality of life and~     reduced heart rate variability during the six minute walk test.~   "
139904|NCT01736124|"~     Computerized cognitive training (CCT) is an intervention has improved cognitive functioning~     in the elderly with and without cognitive impairment. The investigators will study the effect~     of a CCT program over an active control, classic computerized games. The outcomes will be~     memory and executive functions/attention, diabetes elf-management and adherence to~     medications, and glycemic and blood pressure control. Non-demented elderly Veterans with~     diabetes mellitus, who are at high risk for cognitive impairment, will be from the James J.~     Peters, Bronx, NY and Ann Arbor, MI VAMCs. This novel potential service fits the portfolio of~     the Quality Enhancement Research Initiative for Diabetes Mellitus (QUERI-DM) for which the~     Ann Arbor VAMC is a primary center. If successful, the VA National Center for Prevention and~     MyHeatheVet will collaborate in disseminating results to encourage implementation throughout~     the VA~   "
139905|NCT01736111|"~     Overweight and obese adults recruited from the primary care setting (n=150) will be enrolled~     in a 6-month randomized trial of the INTERVENTION versus CONTROL. Both groups will receive~     usual medical care, printed materials, and educational text messages. The INTERVENTION group~     will also receive personalized coaching and feedback, as well as peer support, via text~     message.~      The investigators hypothesize that compared to those in the Control group, patients in the~     Intervention group will lose more weight and demonstrate more favorable changes in fruit and~     vegetable intake, exercise, and social support for weight loss.~   "
139906|NCT01736098|"~     The focus of this randomized clinical trial study is an examination of the effects of~     maintaining energy balance at different energy fluxes. It will address the primary question:~     Are there increased health benefits related to body composition and metabolic function~     associated with maintaining energy balance at a high energy flux as compared to a low energy~     flux?~   "
139907|NCT01736085|"~     The California Smokers' Helpline will conduct a 3 X 2 (nicotine patch by counseling~     condition) randomized trial to test the provision of nicotine patches to help smokers calling~     a telephone quitline. The study assesses one factor related to nicotine patches with 3~     levels: sending patches directly from the Helpline, providing vouchers that can be redeemed~     for patches, and usual care. A second factor is counseling plus materials versus materials~     only. This proposed study has the following specific aims:~        1. To demonstrate that a voucher for free nicotine patches will increase the quit rate for~          smokers who do not have access to free nicotine replacement therapy (NRT)~        2. To demonstrate that sending patches directly from a quitline would outperform sending~          vouchers for free NRT, since the vouchers impose an additional barrier to those who want~          to quit~        3. To determine the effect of telephone counseling in the context of nicotine patch~          distribution and if any interaction effects exist between counseling and patch~          conditions~   "
139922|NCT01735890|"~     The objectives of this study are:~        -  To compare the safety profile of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge~          10/160mg after a single oral administration in healthy male volunteers~        -  To compare the pharmacokinetic profile of CJ Amlodipine/Valsartan 10/160mg and Novartis~          Exforge 10/160mg after a single oral administration in healthy male volunteers~   "
139908|NCT01736072|"~     The purpose of this study is to compare two different surgical procedures for the treatment~     of Rectal Cancer: Laparoscopic Surgery and Robotic Assisted Laparoscopic Surgery. The ROLARR~     study is for participants with cancer of the rectum for whom a laparoscopic operation~     (sometimes called keyhole surgery) has been recommended by their surgeon.~      In the past most rectal cancers were removed using open surgery. Open surgery involves a~     large cut down the middle of the patient's abdomen to allow the surgeon to see and take out~     the cancer. On a previous study showed that using laparoscopic surgery to remove colorectal~     cancers was as good as open surgery for curing cancer.~      There is now another option to remove rectal cancers, which involves using a robotic system~     with laparoscopic surgery. This type of surgery is called robotic-assisted laparoscopic~     surgery and is now becoming widely used by surgeons to remove cancers including the rectum,~     as well as for other non-cancer operations.~      In order to perform robotic-assisted laparoscopic surgery, the surgeon sits at a robotic~     control unit a few feet away from the patient. Using the robotic control unit, the surgeon~     can see a clear video image of the patient's abdomen and the operation site. The surgeon can~     perform the operation from the robotic control unit by controlling the movement of a set of~     robotic surgical instruments, guided by the video camera.~      Like standard laparoscopic surgery, the surgeon is able to carry out the entire operation~     through a few small cuts in the abdomen. The camera of the robotic system provides a 3D~     high-definition magnified view of the operation site and the robotic system is also able to~     translate the movements of the surgeon's hands into small precise movements inside the~     patient's body.~      We want to test whether robotic-assisted laparoscopic surgery is as good, or even better, at~     removing rectal cancers as standard laparoscopic surgery (actually Robotic-assisted~     laparoscopic surgery is used as standard of care in rectal cancer patients at University of~     California, Irvine Medical Center). We also want to investigate whether using~     robotic-assisted laparoscopic surgery reduces the number of times a laparoscopic operation~     needs to be converted to an open operation, and see whether using a robotic system can also~     shorten the length of time patients need to stay in hospital and if it reduces the number of~     complications patients may have during and after their operation.~   "
139909|NCT01736059|"~     This pilot study is to determine whether it would be safe and feasible to inject CD34+ stem~     cells from bone marrow into the eye as treatment for patients who are irreversibly blind from~     various retinal conditions.~   "
139910|NCT01736046|"~     The investigators will be assessing the efficacy of a Model Based Iterative Reconstruction~     algorithm (MBIR) as a noise reduction tool in computed tomographic (CT) examinations for~     Crohn's Disease. MBIR is computer adapted mathematical calculation technique that generates~     CT images with less picture degradation (noise) than traditional computer reconstruction~     techniques such as FBP (Filtered Back Projection) and ASIR (Adaptive Statistical Iterative~     Reconstruction), for enteric Crohn's Disease findings.~      The research involves collection of data from subjects standard of care diagnostic CT scan~     and from a research low radiation dose scan performed immediately following their diagnostic~     scan. We will determine the impact on image quality, interpretability, and Crohn's Disease~     findings of the low dose scan compared to the standard of care scan.~      FBP, MBIR, and ASIR are post processing tools that do not alter the scan acquisition itself.~   "
139911|NCT01736033|"~     The purpose of this study is to evaluate the clinical efficacy of alpha-blocker monotherapy~     and alpha-blocker + 5-alpha reductase inhibitor combination therapy in benign prostate~     hyperplasia patients, and suggest guidelines of the combination therapy.~   "
139912|NCT01736020|"~     This preclinical phase 1 development study in healthy volunteers seeks to identify if low~     doses of commonly used non-triggering anesthetic agents might have clinical utility for~     modulating emotional memory processing and to understand the nature of the brain mechanisms~     of drug action. Optimally, a drug, dose and brain mechanism of action will be identified that~     will form the foundation for future use in clinical studies of patients with PTSD.~   "
139913|NCT01736007|"~     Alopecia Areata (AA) is a skin restricted autoimmune disease of the hair follicle, resulting~     in hair loss of the scalp, and in severe cases of the entire body. AA is the second most~     common cause of alopecia in childhood; no FDA-approved treatments exist. The use of focused~     narrow-band ultraviolet-B light via the excimer laser is a common treatment for many skin~     diseases in patients of all ages. In this study, the feasibility of the 308-nm excimer laser~     for treatment of patch type AA of the scalp will be examined. We anticipate the excimer laser~     will be safe and a feasible option for patients with patch type AA. The excimer laser may~     represent a novel treatment for childhood AA and no comparison or large studies currently~     exist in the literature.~      Hypotheses The 308-nm excimer laser procedure is a feasible, well-tolerated and safe~     treatment for patch type alopecia areata of the scalp in children.~   "
139914|NCT01735994|"~     Given the cost of treating eating disorders and the substantial morbidity and mortality~     associated with these disorders, prevention of eating disorders has considerable public~     health significance. Female athletes represent an important population for prevention due to~     their risk for the Female Athlete Triad, which includes inadequate energy intake, irregular~     or cessation of menses, and osteoporosis. The proposed randomized controlled trial will~     provide important information regarding the efficacy, acceptability, and feasibility of~     implementing a brief eating disorder prevention and healthy living program within an existing~     social system of female athletes.~   "
139915|NCT01735981|"~     To examine the benefits of using a video-game, Dance, Dance, Revolution, as an exercise~     modality to improve gait and balance in individuals with Huntington's disease.~   "
139916|NCT01735968|"~     The purpose of this study is to determine a maximum tolerated dose and/or recommended phase 2~     dose of a combination of imatinib and BYL719 in the treatment of 3rd line GIST patients.~   "
139917|NCT01735955|"~     The purpose of this study is to allow continued use of nilotinib in patients who are on~     nilotinib treatment in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs~     (CD&MA) study and are benefiting from the treatment as judged by the investigator~   "
139918|NCT01735942|"~     The purpose of this study is to find out the effectiveness of ingenol mebutate compared to~     cryotherapy (freezing of the tissue) for the treatment of face and scalp skin lesions.~   "
139919|NCT01735929|"~     The purpose of this study is to find out the effectiveness of ultrasound treatment and~     liposuction combined on skin tightening around the neck.~   "
139920|NCT01735916|"~     This study is looking at whether the electrical treatment provided by a special type of~     pacemaker called a Cardiac Resynchronization Therapy (CRT) pacemaker may keep a patient's~     heart failure from getting worse. When the lower heart chambers (i.e. ventricles) are~     electrically paced to beat together by the CRT pacemaker, blood may be pumped to the body~     more efficiently.~      The CRT pacemaker being studied in this clinical trial is approved by the US Food and Drug~     Administration (FDA) for patients with moderate to severe heart failure, whose hearts pump~     blood inefficiently. In the MIRACLE EF study, patients who have heart failure with slightly~     less inefficient hearts will be observed to see if the electrical pacing treatment is better~     than not getting the treatment. This study is being conducted to support FDA approval of this~     type of pacemaker for people whose heart failure is less inefficient.~   "
139934|NCT01735734|"~     The purpose of this observational study is to ascertain the effects of cutaneous air cooling~     on vessel diameter within Capillary Malformations (CM).~   "
139923|NCT01735877|"~     Hemi spatial neglect, or the tendency to ignore stimuli originating in a portion of the~     environment contra lateral to a cerebral lesion, can be a major source of functional handicap~     after stroke. The currently available treatments for unilateral neglect are scanning~     training, visual cuing approaches, limb activation strategies, visual imagery, tactile~     stimulation, prisms and sustained attention training.Mirror therapy improves the hand~     function in sub-acute stroke.~      Hypothesis: To evaluate the effectiveness of Mirror therapy in the management of stroke~     patients with unilateral neglect.~   "
139924|NCT01735864|"~     The use of refined indigo naturalis (indigo naturalis extract in oil, INEO)ointment to treat~     psoriasis has been proven effective in our previous study. This study aims to evaluate the~     efficacy and safety of INEO ointment, and further determine the optimal concentration of INEO~     ointment (per gram of ointment containing either 200 μg, 100 μg, 50 μg or 10 μg of indirubin)~     in treatment of various local skin signs and thickness of psoriasis plaque.~   "
139925|NCT01735851|"~     Pain following abdominal surgery is managed with the use of thoracic epidural analgesia (TEA)~     where the epidural is inserted in the spine at the level of scapula The risks due to TEA~     include difficulty with insertion, failure in up to 40% of patient in the perioperative~     period, fall in blood pressure and a rare devastating complication of paralysis either due to~     bleeding or infection. Injury to spinal cord is also a feared complication. Therefore~     alternative techniques need to be evaluated. Paravertebral block (PVB) has been documented to~     provide pain relief following abdominal surgery using an earlier technique which posed the~     risk of puncture of the covering to the lung (pleura) resulting in pneumothorax. The current~     technique involves the use of curled catheters inserted using ultrasonography to lie outside~     the pleura where the nerves travel thus reducing the chances of pneumothorax and catheter~     migration. Objective of the current study is to compare the efficacy and safety of bilateral~     PVB with TEA. Patients undergoing bowel surgery will be randomized to receive thoracic~     epidural analgesia or bilateral thoracic paravertebral blocks. Pain scores during rest and~     coughing, failure and complication rates will be compared between the two groups.~      Objective:~      The objective of the investigators is to determine whether ultrasound (US)-guided bilateral~     thoracic paravertebral blocks (PVB) using curled catheter provides effective post-operative~     analgesia as compared to thoracic epidural analgesia in patients undergoing open abdominal~     bowel surgeries.~      The primary outcome of this study will be the pain scores over the first 24 hours following~     open bowel surgeries.~      Secondary outcomes include~        1. Analgesic consumption in the perioperative period,~        2. Block related data (block performance time, success rate, extent of sensory block,~          complications)~        3. Hemodynamic parameter every 6 hourly~        4. Incidence of side effects like nausea and pruritus scores, time to return of bowel~          activity~      Hypothesis~      Null Hypothesis: Primary.~      Paravertebral blocks provide equal analgesia in the early postoperative period (first 24~     hours of surgery) as compared to thoracic epidural analgesia in patients undergoing bowel~     surgeries by laparotomy.~      Secondary~        1. The analgesic consumption between PVB and TEA is not different during the first 24 hours~          following surgery~        2. The block performance time, success rate and extent of sensory block with PVB are not~          different from that of TEA.~        3. Side effects and complications following bilateral PVB are not different from those~          occurring after TEA~   "
139926|NCT01735838|"~     Summary Rationale: Cardiac resynchronisation therapy (CRT) with biventricular pacemakers and~     implantable cardiac defibrillators (ICD) has proven to be a valuable therapy in selected~     patients with systolic heart failure, ameliorating both morbidity and mortality. However,~     with current selection criteria and implant technique, about 20 to 30 % of patients remain~     non-responders. Non-responders might be due to failing selection criteria or methodology in~     casu echocardiography. Moreover, the definition of response to CRT is unequivocal and there~     is a need for a simple and reproducible measure of response with low inter- and~     intra-observer variability.~      Primary objectives: This study evaluates the correlation between intrathoracic blood volume~     (ITBV) measured by contrast enhanced ultrasound (CEUS) and magnetic resonance imaging (MRI),~     as well as the feasibility to use intrathoracic blood volume as a predictor for response to~     CRT.~      Study design: a prospective nonrandomized pilot study Study population: patients with heart~     failure New York Heart Association (NYHA) class III or IV, a left ventricular ejection~     fraction equal to or less than 35% and a QRS-duration equal to or more than 0.12 seconds who~     are referred to our centre for implantation of a CRT-P or CRT-D device.~      Intervention: No specific intervention will be performed. Main study parameters: correlation~     between intrathoracic bloodvolume measured by CEUS and MRI, correlation between LVEF measured~     by CEUS and by standard 2D ultrasound (biplane methods of discs), change in intrathoracic~     blood volume as a response to CRT.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: at baseline a clinical examination, laboratory analysis, cardiopulmonary~     exercise testing, echocardiography and cardiac magnetic resonance imaging will be performed.~     All of these examinations will be repeated at 3-months follow-up except for the cardiac~     magnetic resonance imaging. All examinations, except for the MRI, are part of the standard~     workup in our hospital for patients undergoing implantation of a CRT device. Data needed for~     the purpose of this study, will be acquired by offline image analysis with dedicated~     software.~   "
139927|NCT01735825|"~     The purpose of this study is to compare efficacy of coronary in-stent restenosis therapy~     using drug eluting paclitaxel-coated balloon catheters with the latest generation of drug~     eluting stents releasing everolimus.~   "
139928|NCT01735812|"~     The goal of this study is to evaluate the safety & efficacy of cryoablation using IceCure~     medical's IceSense3™ device for the treatment of symptomatic uterine fibroids in a~     percutaneous lap-assisted approach.~   "
139929|NCT01735799|"~     Since both pathologies (PCOS and NAFLD) involve disturbed carbohydrate economy, which revolve~     around insulin resistance, it is tempting to examine the specific liver profile of women~     with PCOD. Furthermore, it would be of great importance if lean women who suffer from PCOD~     would be revealed to shere cardiovascular risks with their more overweight peers.~      Patients - women who will be diagnosed with PCOD following their initial referal to our~     fertility clinic. Controls - normal ovulatory women who approached our fertility clinic due~     to either unexplained or male factor infertility.~      Workup - history for menstrual pattern; Clinical evaluation for features of hyperandrogenism;~     ultrasonographic documentation of ovarian morphology; follicular phase hormonal profile for~     validation of the diagnosis and for ruling out other pathologies which may cause anovulation.~      Liver profiling - The following blood tests will be used for the biochemical profiling:~     fasting glucose and insulin, CRP, HDL-cholesterol, triglycerides, AST, ALT, GGT, LDH,~     alkaline phosphatase, total bilirubin, direct bilirubin, ferritin, HBA1C and micro albumin~     ratio.~      FibroScan® will be used to measure liver stiffness.~   "
139930|NCT01735786|"~     Endoscopic mucosal resection (EMR) has been widely used as a diagnostic and treatment~     techniques of gastrointestinal small lesions. Postoperative rebleeding is one of the common~     complication following EMR. Several endoscopic hemostasis methods are currently in use.~     EndoClot® absorbable polysaccharide hemostat (PAPH) as a new hemostasis material was~     previously used for surgical hemostasis, but the therapeutic effect and safety in endoscopic~     application remains unknown. This study has been designed to observe the effect of rebleeding~     prevention after EMR.~   "
139931|NCT01735773|"~     The investigators aimed to study the effect of prohepcidin levels on hematologic parameters~     and inflammatory markers in non-diabetic uremic patients. The investigators selected three~     groups of patients: Hemodialysis group, peritoneal dialysis group and the group with stage 4~     chronic kidney disease. A control group was formed from healthy volunteers also. Each group~     has been planned to be formed of about 25 patients. Diabetic patients were excluded.~     Prohepcidin, hsCRP, IL-6, fibrinogen have been planned to be studied besides other routine~     biochemical analysis including hematological ones.~   "
139932|NCT01735760|"~     Anesthesiologists get a course on localizing the cricothyroid membrane on a human using~     ultrasonography. Thereafter their ability to localize the cricothyroid membrane with either~     palpation or ultrasonography, in a randomised fashion, is tested.~   "
139939|NCT01735669|"~     Objectives: The objective is to demonstrate the superiority of remifentanil versus nitrous~     oxide as adjuvant analgesic treatment to increase the chances of success of external cephalic~     version in the management of non-cephalic presentation in women with singleton pregnancy at~     term. Another objective is to compare their safety, tolerability and acceptability.~      Methodology: single-center clinical trial, randomized, open, parallel-group and sequential~     design, with active comparator. Pragmatic approach. Sequential design of O'Brien-Fleming with~     two interim analysis. Analysis by intention to treat. Comparison of the rate of successful~     version, referred to analgesic effect, safety, caesarean rates and acceptability rate of the~     procedure for pregnant women.~   "
139940|NCT01735656|"~     Percutaneous coronary intervention (PCI) for the treatment of coronary bifurcation lesion~     (BL) remains a challenging task. The DK-crush have been established as a safe and efficacious~     dual-stenting technique, which can effectively improve the success rate of final kissing~     balloon inflation (FKBI) and reduce long-term major adverse cardiac events (MACE). However,~     in the clinical real world, especially when the bifurcation angle was relatively small, the~     DK-crush still has several limitations, such as kissing unsatisfied (KUS), relatively complex~     wiring or rewiring technique, incomplete stent coverage in the distal side of the side-branch~     ostium and near the carina, severe stent deformation or evenly acute stent destruction. Our~     observational study showed that the DK-culotte was also a safe and feasible dual-stenting~     technique and was equal to DK-crush in terms of improving FKBI and MACE. Nonetheless, there~     remain no studies for head-to-head comparison of clinical outcomes between the two~     approaches. We, thereby, carry out a multicentre, non-inferior, randomized and controlled~     trial to compare DK-culotte stenting versus DK-crush stenting in the treatment of true BL.~   "
139941|NCT01735643|"~     Due to overweight and unhealthy lifestyle the number of patients with type 2 diabetes~     mellitus is increasing. Although in early phases the disease might be successfully treated by~     lifestyle change patients lack for motivation. Instead of increasing anti-diabetic medication~     a highly motivational system with low inhibition threshold is needed. Therefore, the~     investigators analyzed if regular use of the interactive videogame Wii Fit Plus over 12 weeks~     is able to improve HbA1c and weight in patients with type 2 diabetes.~   "
139942|NCT01735630|"~     The primary purpose of this study is to determine whether ELND005 is effective in treating~     symptoms of agitation and aggression in patients with Alzheimer's disease~   "
139943|NCT01735617|"~     The purpose of this study is to gather safety and effectiveness information about a new~     formulation of Hydrocortisone (Chronocort®) used to treat patients with a disease called~     congenital adrenal hyperplasia (CAH). Hydrocortisone is the man-made version of the hormone~     cortisol, which is released in the body following a regular daily pattern. The objective of~     the study is to measure the levels of hydrocortisone that are absorbed into the bloodstream~     once Chronocort® is taken and what affects it has on other hormones in the body. Since~     Chronocort® is anticipated to mimic the same release pattern of cortisol in the body, it is~     hoped that patients with CAH will be treated more effectively to manage their disease.~   "
139944|NCT01735604|"~     RATIONALE: Placing a gene that has been created in the laboratory into white blood cells may~     make the body build an immune response to kill cancer cells.~      PURPOSE: This clinical trial is studying genetically engineered lymphocyte therapy in~     treating patients with B-cell leukemia or lymphoma that is resistant or refractory to~     chemotherapy.~   "
139945|NCT01735591|"~     The aim of this study was to evaluate the impact of the administration of probiotics on~     outcomes of patients qualified for liver transplantation, both in the pre-transplant period~     and in the early postoperative period.~   "
139946|NCT01735578|"~     Necrotizing enterocolitis (NEC) is the most common gastrointestinal emergency encountered in~     the newborn intensive care unit and represents a significant cause of morbidity and mortality~     in infants born prematurely. Among possible risk factors, a strong association between~     elective RBC transfusions in premature infants with anemia and the subsequent development of~     NEC has been consistently observed (6-11). However, a significant (and increasing) number of~     VLBW infants with anemia are managed with erythropoiesis stimulating agents (such as Epo) and~     iron and do not receive RBC transfusions during their hospital stay. The present study~     proposes to study this particular group of VLBW infants that remain with low (<28 %)~     hematocrit while receiving full enteral feedings.~      The investigators hypothesize that significant anemia in VLBW infants will be associated with~     a baseline low cerebro-splanchnic oxygenation ratio (CSOR) (<0.75) as measured by NIRS, and~     that nasogastric feedings (NGF) in those particular patients will lead to further decreased~     splanchnic oxygenation. The investigators further postulate that CSOR values will be~     significantly lower among VLBW that develop NEC as compared to infants that do not.~   "
139947|NCT01735565|"~     This is a prospective observational study to determine the point after bone marrow transplant~     in adults and children at which the neutrophils derived from the transplanted stem cells are~     competent to form functional neutrophil extracellular traps (NETs). Furthermore, given the~     importance of platelet function for NET formation, we also plan to examine platelet~     activation and function as well as the platelet transcriptome using the same clinical~     samples.~   "
139948|NCT01735552|"~     Despite many advances in neonatal care, necrotizing enterocolitis (NEC) remains a leading~     cause of morbidity and mortality among premature infants. NEC is the most common~     life-threatening gastrointestinal emergency encountered in the neonatal intensive care unit,~     affecting between 3.8% and 13% of very low birthweight (VLBW) infants (1-3). More recently~     interest has intensified regarding the possible association between elective red blood cell~     (RBC) transfusions in premature infants and the subsequent development of NEC (4-9). On a~     physiological basis, a few explanations for transfusion-associated NEC have been proposed: 1)~     the physiological impact of anemia that can initiate a cascade of events leading to~     ischemic-hypoxemic mucosal gut injury predisposing to NEC [10]; and 2) increased splanchnic~     blood flow following RBC transfusion leading to reperfusion injury of gut mucosa.~      Aim 1. This study will quantify inflammatory cytokine profiles in anemic infants cared for in~     the NICU prior to and after transfusion with packed red blood cells (PRBC), as dictated by~     current clinical guidelines for treatment of anemia, and prospectively assess for clinical~     signs and symptoms of NEC following each transfusion event.~      Aim 2. Polymorphonuclear leukocytes (PMNs) isolated from the pre- and post-transfusion blood~     samples will be assessed in vitro for neutrophil extracellular traps (NET) formation.~      Aim 3. A) To determine whether significant anemia preceding a RBC transfusion is associated~     with impaired intestinal oxygenation, and whether a RBC transfusion temporarily increases~     splanchnic oxygenation. We postulate that the CSOR will be low (<0.75) at baseline~     measurement in infants with hemodynamically significant anemia, and that RBC transfusion will~     temporarily increase intestinal perfusion in that particular group of babies.~      B) To determine whether alterations in mesenteric regional oxygenation saturation(rSO2) can~     predict the development of NEC in VLBW infants. We hypothesize that overall~     cerebro-splanchnic oxygenation ratio (CSOR) values will be significantly lower among very low~     birth weight (VLBW) infants that develop NEC, when compared to CSOR values obtained in~     infants that do not develop NEC following RBC transfusion.~   "
139949|NCT01735539|"~     The investigators plan to measure changes in muscle protein metabolism in response to~     feeding, comparing between a single large essential amino acid (EAA) feed (the normal~     building blocks of protein) and the provision of the same dose in 4 smaller feeds at 45min~     intervals. The investigators will perform this study in healthy older (65-75y) and younger~     (18-28) men. The investigators will also explore how feeding affects muscle blood flow as~     this is important in the delivery of the nutrients we eat to the muscle where they are used.~      The investigators plan to supplement the feed with arginine, a safe and widely found~     non-essential amino acid, to explore if this can improve muscle blood flow.~   "
139950|NCT01735526|"~     Early after allogeneic hematopoietic stem-cell transplantation (allo-HSCT), reductions of~     absolute lung volume and diffusing capacity for carbon monoxide (DLCO) are frequently~     detected even in the absence of overt idiopathic pneumonia syndrome (IPS). It can be~     hypothesized that these changes might be due to an occult intersitial lung disease associated~     with infections, acute Graft-versus-Host Disease (aGvHD), myeloablative conditioning regimens~     or any combination of these. To test this hypothesis, we will simultaneously measure the lung~     diffusing capacity for nitric oxide (DLNO) and DLCO and estimate the changes of membrane~     diffusing capacity (DM) and pulmonary capillary volume (Vc) by the DLNO/DLCO ratio. As we~     hypothesize that GHVD should be intuitively absent amongst autologous HSCT (auto-HSCT)~     recipients, we will compare the changes in DLNO/DLCO ratio showed by the latter group with~     those of subjects undergoing allo-HSCT.~   "
139951|NCT01735513|"~     Study hypothesis: Reduction of cerebral embolic lesions during transcatheter aortic valve~     implantation by the use of an embolic protection device.~   "
139952|NCT01735500|"~     A prospective Study, aiming to understand and analyse the key role of the novel High~     Sensitivity Troponin T (hsTnT) within a group of patients undergoing an uncomplicated~     coronary angiography without receiving any additional intervention. The peri-procedural~     elevation of the hsTnT indicates some other factors being responsible for the elevation of~     the hsTnT in absence of an acute coronary syndrome, such as physiological components or~     micro-injuries. A one year follow-up has been collected.~   "
139953|NCT01735487|"~     The aim of the present study is to compare cognitive scores (attention, executive function~     and working memory) of different e-Cigarette strength with usual cigarettes.~   "
139954|NCT01735474|"~     The main objective of this study is to evaluate the effectiveness of different manual~     techniques included traditionally on respiratory physical therapy~   "
139955|NCT01735461|"~     Hospitalization for kidney stones in the Inflammatory Bowel Disease (IBD) population is~     common, particularly among Crohn's patients who had a small bowel resection. This patient~     population experiences a lifetime occurrence of kidney stone formation as high as 25%~     accompanied with a high rate of recurrence (the typical rate of stone formation is ~10% in~     the non IBD population). Giving oral calcium is used to bind oxalate in the intestine in an~     attempt to reduce the amount of oxalate that is absorbed into the body and to reduce urinary~     oxalate levels. However, there are no defined guidelines for the optimum dosing of calcium.~     This study's primary objective is to scientifically define an appropriate range of calcium~     supplementation that reduce the level of oxalate found in the urine of patients living with~     inflammatory bowel disease.~   "
139956|NCT01735448|"~     Aim: To identify barriers and facilitators in the uptake of smoking cessation~     pharmacotherapies, tobacco prevention, doctor visits, smoking amongst youth, community held~     health priorities and barriers to research in Aboriginal Australians from the perspectives~     of:~        -  Aboriginal smokers and ex/non-smokers~        -  Aboriginal Healthcare workers~        -  Consultants/general practitioners, and~        -  Key stakeholders in Aboriginal health~      Focus groups, one-on-one interviews and surveys will be conducted to provide information at~     the 'grass-roots' level including examinations into perceived differences in locally held~     beliefs, attitudes, knowledge, traditional practices and the cultural and social constructs,~     to assist implementation of future tobacco cessation/prevention interventions and treatment~     of smoking related illnesses. This information can be used to improve the health of~     Aboriginal people by identifying inadequacies in current practices and highlighting what~     these are through the eyes of community members, healthcare workers, consultants/general~     practitioners and key stakeholders. We also intend on examining any facilitators that are~     identified as positive and working aspects of current initiatives e.g. community~     infrastructure, in an effort to not 'reinvent the wheel' and acknowledge what is working.~   "
139957|NCT01735435|"~     The aim of this study to assess the impact of nutritional support guided by repeated~     measurements of REE in geriatric patients following surgery for hip fractures.~      Our hypothesis is that tight caloric control will reduce the risk of significant~     postoperative complications in geriatric patients following surgery for hip fractures.~      Study Design :Prospective, Single center, Randomized, Unblinded study. Study~     Population:geriatric patients following surgery for hip fractures.~   "
139958|NCT01735422|"~     This is a single center, open-label, randomized, parallel group, dose finding study to~     evaluate safety and efficacy of recombinant human luteinizing hormone (r-hLH, LHadi®),~     compared with urinary human chorionic gonadotrophin (u-hCG, Profasi®), both given~     subcutaneously, in inducing ovulation in infertile women undergoing stimulation of follicular~     growth with recombinant human follicle stimulating hormone (r-hFSH, Gonal-F®).~   "
139959|NCT01735409|"~     This is a single center, non-randomized phase IIa study to determine the tolerance and safety~     of Abraxane (ABX) in combination with cisplatin (DDP) in patients with advanced~     nasopharyngeal carcinoma (NPC). Patients in whom the standard therapy had failed or had been~     infeasible will be eligible.The safety and efficacy will be evaluated according to NCI-CTCAE~     V4.0 and RECIST 1.1 respectively.~   "
139960|NCT01735396|"~     This is a pilot study of abiraterone acetate in African American/Black patients with~     castration-resistant prostate cancer. The primary objective is to determine the correlation~     between germline polymorphisms and antitumor activity (as defined by a decline in PSA of ≥~     30%) in African American patients with castration-resistant prostate cancer treated with~     abiraterone acetate. Patients will receive abiraterone acetate until the time of disease~     progression, in the absence of prohibitive toxicities. Patients will be followed for disease~     progression and survival.~   "
141832|NCT01710813|"~     To collect uniform and meaningful data on patients with Pompe disease who experience~     anaphylaxis, severe allergic reactions, and/or signals of severe cutaneous and/or systemic~     immune complex-mediated reactions following treatment with alglucosidase alfa.~   "
139961|NCT01735383|"~     This is a open Label, balanced, randomized, single dose, two-treatment, two-sequence,~     two-period, crossover pivotal study. The purpose of this study is to assess the~     bioequivalence between Test Product and the corresponding Reference Product under fed~     condition in healthy, adult human subjects.~   "
139962|NCT01735370|"~     This is a open Label, balanced, randomized, single dose, two-treatment, two-sequence,~     two-period, crossover pivotal study. The purpose of this study is to assess the~     bioequivalence between Test Product and the corresponding Reference Product under fasting~     condition in healthy, adult human subjects.~   "
139963|NCT01735357|"~     The purpose of this study was to determine whether supplementation with oils enriched with~     long chain n-3 PUFA, either EPA or DHA, had a differential effect on platelet, endothelial~     and vascular function.~   "
139964|NCT01735344|"~     This is a randomized, balanced, open Label, two-treatment, two-period, two-sequence, single~     dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence~     between Test Product and the corresponding Reference Product under fed condition in normal,~     healthy, adult, male and female human subjects.~   "
139965|NCT01735331|"~     The aim of this study is determine vascular endothelial growth factor levels and~     angiogenesis/vascularity from hysteroscopic endometrial biopsies which taken from patients~     who has Recurrent Pregnancy Loss.The endometrial vascular endothelial growth factor levels~     will be measured by immunohistochemical staining methods due to office hysteroscopic~     endometrial biopsy after the menstruation at follicular phase of menstrual cycle.~   "
139966|NCT01735318|"~     This is a randomized, balanced, open Label, two-treatment, two-period, two-sequence, single~     dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence~     between Test Product and the corresponding Reference Product under fasting condition in~     normal, healthy, adult, male and female human subjects.~   "
139967|NCT01735305|"~     Antiplatelet therapy is the cornerstone for the prevention of atherothrombosis in patients~     with coronary artery disease (CAD). However, the efficacy and safety of antiplatelet therapy~     are varied due to ethnic and/or individual variability. The aim of the OPT-CAD study was to~     demonstrate contemporary status and outcomes of antiplatelet therapy in Chinese CAD patients,~     and to explore predictors of ischemic or bleeding events in such cohort.Patients above 18~     years old who were diagnosed as CAD and received antiplatelet therapy were prospectively~     enrolled in this national wide, non-intervention registry. All medications and laboratory~     tests were physician discretion.~   "
139968|NCT01735292|"~     The Israel Terminally Ill Law, 2005 allows patients who are terminally ill and ventilated to~     have their ventilator placed on a timer which at a specific time in the future stops the~     ventilator, maintains the patient on positive pressure (CPAP) and allows the patient not to~     be reconnected to the ventilator. We will evaluate the safety of the Automatic Respiration~     Transfer-Timer by assessing vital signs, oxygenation and ventilatory pressures and volumes~     during the use of the timer with the regular ventilator. In addition, we will evaluate~     whether the timer stops the ventilator and switches to CPAP at the designated time.~   "
139969|NCT01735279|"~     Nicotine dependence may prolong the exposure to toxic substances that cause various diseases.~     The Central Nervous System (CNS) is consisted by a large amount of Polyunsaturated Fatty~     Acids (PUFAS) from omega-3 serie. Omega-3 takes part in several actions, including the~     modulation of dopaminergic neurotransmission. In its deficiency is detected a hypofunctioning~     of the mesolimbic and mesocortical pathway, related to the reward system, involved on the~     context of nicotine dependence. Treatment using dietary supplementation with omega-3 shows~     improvements in several diseases, including mood disorders such as anxiety and depression.~     The investigators hypothesis is that supplementation with these fatty acids can restore the~     levels of omega-3 and could decrease nicotine dependence. The investigators objective is to~     investigate a possible association between increased serum levels of omega-3 and the~     reduction in nicotine dependence.~   "
139970|NCT01735266|"~     In most of situation, left colon (especially SD junction) is considered the most difficult~     part of colonoscopy, where endoscopist may encounter difficulty for scope insertion and~     patients may feel pain or uncomfortable. It is suggested more than half of the whole time for~     scope insertion should be used in left colon. Many methods, such as water immersion,~     abdominal palpation, have been used to facilitate insertion in left colon.~      Colonoscopy with whole-colon water exchange method has been shown to be useful for reducing~     medication used, pain experienced during colonoscopy, increasing the success rate of cecum~     intubation and adenoma detection rate in sedated and unsedated patients undergoing screening~     colonoscopy. Exchange of water during scope insertion minimizes loop formation and prevents~     lengthening and distension of the colon during colonoscopy. This will facilitate the~     colonoscopy in average or difficult colonoscopy. However, it is not known whether the~     benefits of water exchange method of colonoscopy was mainly due to its effect on the left~     colon.~      We hypothesized that left-colon water exchange colonoscopy (LWE) may have the similar effect~     regarding the maximal pain score and mean pain score in unsedated patients compared with~     whole-colon water exchange colonoscopy (WWE). At the mean time, LWE may reduce the insertion~     time compared with WWE. Here we performed a prospective, randomized controlled study to~     investigate the efficacies of whole-colon water exchange, left-colon water exchange and air~     methods of colonoscopy on pain score and insertion time in unsedated outpatients.~   "
139971|NCT01735253|"~     Surgical treatment for type 2 diabetes has been taken note especially in less obese or non~     obese patients. In Asian, the nuber of less obses or non obese patients with T2DM is greater~     than that of the obese.~      We are trying to do a prospective observational study for the evaluation of the effect of~     duidenojejunal bypass and gastric bypass on the glycemoc control in those patients.~      The selection criteria are type 2 diabetess, 20-60 years old, BMI 23-34 or 21-22 with viceral~     obesity, insulin use less than 10 years and the patients understanding the hypothesis of this~     study, risks, expecting effects and agreeing this study.~      We are checking oral GTT, insulin level, C-peptide level, HbA1C, etc. with some~     anthropometric measurs preoperatively, postoperatively, at 3 month and 12 month.~      We will compare the clinical factors at each time.~   "
139972|NCT01735240|"~     The main purpose of the study is to compare the change of the AZD5069 Pharmacokinetic profile~     when administered with ketoconazole. Subjects will be treated first with AZD5069 only~     followed by a washout period before starting with the combined treatment (both ketoconazole~     and AZD5069).~   "
139973|NCT01735227|"~     In order to further clarify the interaction of PPIs with clopidogrel anti - platelet effect ,~     the investigators designed a clinical randomized controlled trials of omeprazole and~     pantoprazole antiplatelet effect of clopidogrel .In this experiment , the investigators have~     taken a randomized NSTE-ACS hospitalized patients met the inclusion criteria were randomly~     divided into omeprazole and pantoprazole groups . On the day of admission , all patients~     taking clopidogrel loading dose 300mg + aspirin 300mg and the subsequent maintenance dose of~     clopidogrel 75mg + aspirin 300mg and omeprazole group taking omeprazole 20mg / d ,~     pantoprazole group taking pantoprazole 20mg / d. Respectively, on the day of admission (~     before medication ) , medication for 12-24 hours , medication after 72 hours , 30 days , each~     taken early morning fasting venous blood again , measuring AA 、ADP - induced platelet~     aggregation . And selected 30 days , 6 months and 12 months to record the patient's clinical~     adverse events ( including death , myocardial infarction , and any revascularization , stent~     thrombosis , recurrent angina , rehospitalization due to cardiovascular disease , bleeding~     events) . To assess the impact of PPIs on clopidogrel antiplatelet effect by observing 1 year~     follow-up results , and further explore the optimal combination of dual anti-platelet and~     joint PPIs course of treatment , appropriate dosage and the best time to provide reasonable~     for clinical programs to create a personalized treatment system , improve the patient's~     quality of life .~   "
139974|NCT01735214|"~     This study is a prospective, observational study of changing from any IOP-lowering treatment~     to a prostaglandin analogue-containing IOP-lowering medication for patients with Primary Open~     Angle Glaucoma (POAG) or Ocular Hypertension (OHT). The decision to change medications lies~     with the physician according to their standard practice.~   "
139975|NCT01735201|"~     This study will evaluate the safety and efficacy of 3 doses of AGN-199201 once and twice~     daily compared to vehicle for the treatment of moderate to severe facial erythema associated~     with rosacea.~   "
139976|NCT01735188|"~     Primary objective:~      Characterize the natural history of MoCD type A in terms of survival~      Secondary objectives:~        1. Evaluate blood and urine for biochemical markers~        2. Evaluate head circumference, seizure activity and neurologic outcomes~        3. To evaluate brain MRI~        4. Compare blood and urine analysis, head circumference, seizure activity and neurologic~          outcomes to MRI findings~   "
139977|NCT01735175|"~     The study will assess the efficacy of LA-EP2006 compared to Neulasta® with respect to the~     mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in~     breast cancer patients.~   "
139978|NCT01735162|"~     Acute kidney injury (AKI) is a common clinical event with severe consequences. In the~     pediatric intensive care unit (PICU), AKI occurs in almost 10% of all patients and evidence~     suggests that children are dying not just with AKI, but from AKI. Unfortunately, the~     treatment for AKI is limited to a great extent by delayed diagnosis. Reliance on markers of~     kidney injury that change only when significant damage has already occurred has rendered~     potential therapies ineffective. For this reason, identification of new markers of AKI that~     change early in the course of injury is paramount. While new AKI biomarkers have been~     identified, their performance in the general PICU population is variable. The investigators~     recently proposed the concept of 'renal angina' as a way to risk stratify patients in the ICU~     for AKI risk. In the AKI-CHERUB study, the investigators propose to study renal angina in~     PICU patients alone and in combination with urinary biomarkers for AKI prediction. The~     investigators hypothesize that renal angina will increase the predictive precision of urinary~     biomarkers for AKI.~   "
139979|NCT01735149|"~     The investigators performed a 12-week, randomized, double-blind, placebo-controlled human~     trial to evaluate the efficacy and safety of Kochujang pills on improvement of blood lipids.~     The investigators measured improvement of blood lipids parameters , including Total~     Cholesterol, LDL-C, Triglyceride and HDL-C, and monitored their blood pressure.~   "
139980|NCT01735136|"~     The investigators performed a 4-week, randomized, double-blind, placebo-controlled human~     trial to evaluate the efficacy and safety of InSan Bamboo Salt on improvement of Helicobacter~     pylori infection. The investigators measured improvement of Helicobacter pylori infection~     parameters , including 14C-UBT(Urea breath test), and subjects' symptoms, and monitored their~     blood pressure.~   "
139981|NCT01735123|"~     The proposed mechanistic formula feeding study sets out to identify the mechanism(s) by which~     an extensively hydrolyzed casein formula is able to protect children at risk for type 1~     diabetes (T1D) from beta-cell autoimmunity.~   "
139982|NCT01735110|"~     The purpose of PREPARE trial is to evaluate the long-term safety and efficacy of TRI versus~     TFI for PCI in patients with left main (LM) and/or three-vessel coronary artery disease.~   "
139983|NCT01735097|"~     Daily intake of Nigella sativa for 12 weeks is effective in the treatment of palmer arsenical~     keratosis~   "
139984|NCT01735084|"~     HYPOTHESES:~        1. That infants receiving PHiD-CV10 as a booster at 13 months of age, compared to controls~          having no PHiD-CV10 booster (i.e. standard PCV13), will have higher HiD antibody levels,~          lower carriage of NTHi, and less tympanic membrane perforation at 18 and 36 months of~          age.~        2. That infants receiving PCV13 as a booster at 13 months of age, compared to controls~          having no PCV13 (i.e. PHiD-CV10 booster) will have higher antibody levels to serotypes~          3, 6A and 19A, less carriage of these serotypes, and less tympanic membrane perforation~          at 18 and 36 months of age.~   "
139985|NCT01735071|"~     This study is aimed at assessing the efficacy and the safety of the combination of~     bevacizumab and trabectedin with or without carboplatin in adult women with epithelial~     ovarian cancer at first recurrence occurred 6-12 months after the end of the last (first or~     second) platinum-containing regimen. According to the Bryant and Day design the primary~     endpoints will be the proportion of progression-free patients at 6 months for the efficacy,~     and the proportion of patients with severe toxicity for the safety at the same time-point.~   "
139986|NCT01735058|"~     This study will be performed to examine the effect of ultrasound-guided subacromial sodium~     hyaluronate injection in patients with impingement syndrome without rotator cuff complete~     tear.~   "
139987|NCT01735045|"~     This study is to evaluate the performance of the LSH (mangofilcon A) silicone hydrogel soft~     contact lenses when used as a daily wear contact lens for the correction of myopia.~   "
139988|NCT01735032|"~     Epilepsy is the most common chronic neurological disorder in the world, affecting more than~     50 million people worldwide. Approximately 35% of patients with epilepsy are refractory to~     all available antiepileptic drugs. Drug-resistant epilepsies are often partial or focal.~     Patients with drug-resistant focal epilepsy suffer from an increased risk of death, primarily~     due to seizure-related fatalities, in comparison with the general population. The only~     therapeutic option for this form of epilepsy is the surgical removal of the region of the~     brain responsible for seizures, called the epileptogenic zone (EZ). This requires the precise~     localization of the EZ based on a comprehensive pre-surgical evaluation of patients.~      Today the gold standard for localizing the EZ and validating a non-invasive technique for~     localization of the EZ remains intracerebral stereo-EEG (stereo-electroencephalography or~     SEEG) recordings of spontaneous seizures. The implementation strategy of the intracerebral~     depth electrodes is guided by clinical and neuroimaging data, including anatomical Magnetic~     Resonance Imaging (MRI), Positron Emission Tomography (PET) with FDG (fluoro-Deoxy-Glucose)~     and MagnetoEncephaloGraphy (MEG). Although the contribution of each technique in the~     pre-surgical localization of the EZ has already been shown, no wide-scale study has examined~     the cumulative contribution of these three techniques.~   "
139989|NCT01735019|"~     In patients undergoing hypophysectomy through transsphenoidal approach, preventing cough~     during anesthetic emergence is important to avoid hemorrhage and cerebrospinal fluid leakage.~     Previous reports demonstrated that administration of remifentanil during anesthetic emergence~     could reduce the incidence and severity of cough during anesthetic emergence. Therefore, the~     objective of this study is to determine EC95 of remifentanil for preventing cough during~     anesthetic emergence in patients undergoing hypophysectomy with transsphenoidal approach.~   "
139990|NCT01735006|"~     This is a Phase III clinical trial of the novel recombinant HPV 16/18 bivalent vaccine~     manufactured by Xiamen Innovax Biotech CO., LTD. The primary objective of this study is to~     demonstrate the efficacy of the vaccine against relevant outcomes in healthy women above 18~     years old at enrolment. The secondary objectives are to evaluate the safety, immunogenicity~     and immuno-persistence of the vaccine. Meanwhile, this study tries to compare the difference~     of safety and immunogenicity among different lots. Approximately 6000 study subjects will be~     enrolled and randomly stratified into 2 groups and receive human papillomavirus (HPV)~     vaccine(three different lots) or commercialized hepatitis E vaccine(Hecolin) according to a~     0-1-6 month schedule.~   "
139991|NCT01734993|"~     This multicenter, open-label, single arm, interventional, long-term extension (LTE) study~     will evaluate the safety and efficacy of tocilizumab (TCZ, RoActemra/Actemra) in French~     participants with moderate to severe RA who have completed the Week 97 visit of WA22762 LTE~     study (NCT01194414) (EudraCT Number 2010-018375-22). Participants from France, who completed~     the Week 97 visit of the WA22762 LTE study and considered as responders (defined as having~     improvement in disease activity score based on 28-joint count [DAS28] of greater than [>] 1.2~     points) will continue TCZ treatment within this local LTE study for a maximum of 156 weeks of~     subcutaneous (SC) TCZ treatment, or until SC TCZ becomes commercially available, whichever~     occurs first.~   "
139992|NCT01734980|"~     Cytological diagnostic accuracy between endobronchial ultrasonography endobronchial~     ultrasound transbronchial needle aspiration (EBUS-TBNA) samples using suction versus samples~     when no suction is applied.~   "
139993|NCT01734967|"~     Introduction: Pancreatic cancer is one of the most aggressive malignancies with only 5% of~     patients being alive at five years. EUS (endoscopic ultra sound) is an established, sensitive~     diagnostic tool in pancreatic cancer and for staging purposes. Additionally, EUS enables~     guided fine needle aspiration (FNA), which is currently recommended as the first-line~     procedure whenever a pathological diagnosis is required. However, EUS-FNA as a sampling~     method has its drawbacks, due to a relatively low negative predictive value. Confocal laser~     endomicroscopy has emerged in recent years as a novel method that enables in vivo microscopic~     analysis during ongoing endoscopy. Recently, confocal laser endomicroscopy has gone beyond~     the superficial luminal indications with the development of a new microprobe, i.e. a flexible~     laser probe (nCLE) that can pass through a 19-gauge needle. Combined with EUS, descriptive~     criteria for the diagnosis of pancreatic cystic neoplasm has been developed in a multicentre~     trial. However, only a limited number of cases of solid pancreatic masses have been described~     with nCLE.~      Aim and Method: To describe confocal imaging criteria for pancreatic masses, lymph nodes or~     liver metastases identified during EUS procedures performed for pancreatic cancer staging~     (EUS-nCLE), while evaluating also the feasibility and safety of nCLE examination. The~     hypothesis is that EUS-nCLE could allow targeted tissue sampling of pancreatic lesions~     resulting in more accurate diagnosis. XX patients were included all presenting with a~     clinical suspicion of pancreatic cancer or imaging studies showing a pancreatic mass. During~     the procedure an nCLE preloaded 19G FNA needle was advanced into the lesion under EUS~     guidance. A contrast agent was administered intravenously (2.5 ml fluorescein 10%). The data~     was stored digitally for post procedural analysis. Afterwards EUS-FNA was performed for~     cytology smears to enable a final pathological diagnosis. Correlations between the nCLE~     images and the conventional pathology were identified.~   "
139994|NCT01734954|"~     The purpose of this study is to evaluate the latency period (timing between the injection of~     the local anesthetic and the onset of complete sensory nerve block) of two approaches for~     ultrasound-guided popliteal sciatic nerve block: One of the approaches is the injection of~     the anesthetic just at the site of the bifurcation of the sciatic nerve and the other one is~     injecting the local anesthetic at least 2 cm beyond the bifurcation of the aforementioned~     nerve. Our main hypothesis is that the first approach will decrease the latency period, and~     probably, will increase the success rate of the nerve block as well as patient satisfaction.~   "
139995|NCT01734941|"~     The primary objective of this study is to evaluate and compare the safety and efficacy of~     Trichuris suis ova (TSO) therapy (versus placebo) in pediatric patients with autism.~      Evaluation of the safety and tolerability of treatment with TSO in the target population~     across the dose range being tested is considered a primary objective, while the primary~     efficacy objective will be assessed via the change from baseline in the Aberrant Behavior~     Checklist (ABC) subscale scores.~      Dose response will be considered a primary objective as well.~      Secondary assessments of efficacy will be assessed via:~      • The change from baseline in the Clinical Global Impression scale (CGI-I)~   "
139996|NCT01734928|"~     The purpose of this study is to compare the efficacy of the combination of Pomalidomide,~     Bortezomib and Dexamethasone to the combination of Bortezomib and Dexamethasone in patients~     with relapsed/refractory multiple myeloma. This study will also assess how safe the~     combination of Pomalidomide, Bortezomib and Dexamethasone is compared to the combination of~     Bortezomib and Dexamethasone~   "
140107|NCT01733459|"~     This is a 2-arm, randomized, double-blind, double-dummy, and controlled clinical study, with~     6 months of treatment to evaluate the clinical and metabolic efficacy of DLBS3233 in~     improving reproductive parameters and to evaluate the safety of DLBS3233 in women with~     polycystic ovary syndrome compared with metformin, as an active control.~   "
139997|NCT01734915|"~     The purpose of this research study is to determine if the EGFR mutation can be detected in~     CTCs. CTCs are cancer cells that are shed from solid tumors and float freely in the~     bloodstream. A device called the CTC-chip has been developed to find CTCs in the blood of~     patients with cancer. This is an experimental device. Using this device, the investigators~     will test participants' blood to try and find CTCs with the EGFR mutation and compare them~     with the results from the biopsy your doctor has recommended. The long-term goal of this~     research is to develop a way to test for the EGFR mutation that is less invasive than a tumor~     biopsy.~   "
139998|NCT01734902|"~     The objective of the current trial is to establish the bioequivalence of 2 hyoscine~     butylbromide dose forms following oral administration.~   "
139999|NCT01734889|"~     The purpose of this study is to verify that pediatric patients, especially those who are not~     old enough to swallow capsules, accept the taste and palatability of a new suspension.~   "
140000|NCT01734876|"~     The Parkitouch study compared the effects on pain, sleep quality and HealthRelated Quality of~     Life (HRQoL) among 44 participants with Parkinson´s Disease for at least two years and~     chronic pain.The two groups were randomized to either Tactile Touch and Rest to Music or only~     Rest to Music alone. It was prospective and had a duration of 34 weeks. The first 10 weeks~     was the intervention period , followed by a follow-up period. Outcome measures were salivary~     cortisol concentration measured at seven occasions of which two were immediately before,~     after and 30 minutes after intervention. Diurnal salivary cortisol was calculated based on~     four timepoints of sampling per 24 hour period.~   "
140001|NCT01734863|"~     Local recurrence after surgical resection is a complex phenomenon. An important predictive~     factor is the response to chemotherapy. Central site of disease may be a second independent~     predictive factor (Lin et al. 2007). Patients with more than 10% viable tumour cells at~     surgery following neo-adjuvant chemotherapy had a less favourable outcome with an Event-free~     Survival [EFS] of 47% after 10 years. Patients with good histological response (< 10% viable~     tumour cells) after chemotherapy alone had a prognosis of about 70% after 10 years.~      However, further studies are necessary to determine the merit of adjuvant radiation for~     high-risk patients (poor responders). Taking into consideration that the toxicity and~     morbidity of combined surgery and radiation is greater than either alone and must be closely~     monitored.~   "
140002|NCT01734850|"~     This is an early phase research study looking at whether an experimental gene transfer,~     LVsh5/C46 (also known as Cal-1), is safe and if it can protect the immune system from the~     effects of HIV without the use of antiretroviral drugs.~      Cal-1 is an experimental gene transfer agent designed to inhibit HIV infection through 2~     active parts:~        1. Removing a protein named CCR5 from bone marrow and white blood cells~        2. Producing a protein named C46 on bone marrow and white blood cells~   "
140003|NCT01734837|"~     Laparoscopic appendectomy is progressively accepted as the treatment of choice for acute~     appendicitis. Although the surgical technique of laparoscopic appendectomy has been well~     established, some controversy exists regarding the closure of the appendiceal stump. The~     available methods for stump closure are currently: pre-knotted loops (Roeder Loops or~     Endoloop, linear stapler and polymeric clips. A new device is a the DS Titanium Ligation~     Clip. The design of the DS-Clip is characterized by two parallel shanks.~      The aim of this study is to collect data of a large number of patients treated with the~     product in real-life clinical routine.~   "
140004|NCT01734824|"~     The etiology of bone marrow edema (BME) is still uncertain. Several studies report~     therapeutic success with antiresorptive drugs.~      This study investigates antiresorptive and osteoanabolic drugs versus placebo in BME~   "
140005|NCT01734811|"~     The study will be conducted in two hospitals of the same geographic area. It will be included~     children <3-years-old with recurrent wheezing attacks, confirmed by the review of the medical~     records, in the previous 12 months or a shorter time for those younger than one year.~   "
140006|NCT01734798|"~     Radical Cystectomy is still the standard treatment in muscle-invasive Bladder cancer. Local~     recurrence is still the major cause of failure together with distant metastasis.~     postoperative radiotherapy succeeded to decrease the local recurrence and hence improved the~     overall survival. Adjuvant chemotherapy has also improved the survival in different studies.~     This study is performed to test the efficacy and toxicity of adding the two modalities~     together compared to each modality alone.~   "
140007|NCT01734785|"~     This trial compare the use of two different doses of Empagliflozin to placebo, in T2DM~     patients on 16 wks linagliptin treatment and metformin background therapy.~   "
140008|NCT01734772|"~     To investigate the pharmacokinetic and pharmacodynamic interaction of dabigatran and~     ticagrelor under steady state conditions; to investigate the effect of staggered~     administration of ticagrelor loading dose on dabigatran exposure (in Part II)~   "
140009|NCT01734759|"~     The purpose of this study is to see if a medication taste test influences the prescribing~     habits of pediatric prescribers at Mayo Clinic.~   "
140010|NCT01734746|"~     As most cancers, ovarian cancer also spreads to regional lymph nodes. The concept of sentinel~     lymph node surgery is to see whether the cancer has spread to the very first lymph node or~     sentinel node. If the sentinel node does not contain cancer, there is a high likelihood that~     the cancer has not spread to other lymph nodes. This means that, at least theoretically, a~     radical lymphadenectomy could be omitted and thus the associated morbidity. The sentinel node~     technique has been proven to be effective in different cancers such as breast cancer and~     malignant melanoma. In gynaecological tumors it has been shown to be effective in vulvar~     cancer. Currently sentinel node studies are done for cervix and uterine cancer.~      The present study determines whether or not a sentinel node procedure in patients with~     ovarian cancer is feasible when the tracers are injected in the ovarian ligaments.~   "
140011|NCT01734733|"~     To assess the safety of xenotransplantation of NTCELL [immunoprotected~     (alginate-encapsulated) choroid plexus cells] in patients with Parkinson's disease, assessed~     over the duration of the study, by monitoring the occurrence of adverse events and serious~     adverse events, including clinical and laboratory evidence of xenogeneic infection in~     transplant recipients and their partners/close contacts. Subsequent safety follow-up will~     include lifelong monitoring for clinical and laboratory evidence of xenogeneic infection.~      To assess the clinical effects of NTCELL [immunoprotected (alginate-encapsulated) choroid~     plexus cells] in patients with Parkinson's disease. This will be quantified by testing the~     secondary endpoints of the trial as described below (see Endpoints/Outcome Measures).~   "
140012|NCT01734720|"~     The aims of this study were to~        1. investigate what measures were taken when common bile duct stones (CBDS) were found~          intraoperatively in Sweden during the period May 2005 to December 2009 by using data~          from this population-based nationwide registry, and~        2. analyze the outcome in terms of complications and success rates of bile duct clearance~          in relation to various stone sizes and interventions used. In order to further~          characterize the natural course of CBDS of various sizes, particular interest was~          focused on patients with positive findings where no peroperative measures to clear the~          bile ducts were taken or planned postoperatively.~   "
140013|NCT01734707|"~     This study was designed to estimate the effect of two-year treatment with time-released~     garlic-based drug Allicor on the progression of carotid atherosclerosis in double-blinded~     placebo-controlled randomized clinical trial.~   "
140014|NCT01734694|"~     For more than fifty years, vancomycin has been cited as a nephrotoxic agent. Reports of~     vancomycin induced kidney injury (a.k.a vancomycin induced nephrotoxicity or VIN), have waxed~     and waned throughout the years for various reasons. Recently, VIN has reemerged as a clinical~     concern. This may be due to various reasons, including new dosing recommendations as well as~     an increased prevalence of risk factors associated with vancomycin induced nephrotoxicity.~     This study aims to evaluate a strategy which attempts to reduce kidney damage from vancomycin~     use.~   "
140015|NCT01734681|"~     Prostate cancer that has returned after local treatment usually responds to hormone blocking~     treatment, but most patients eventually experience disease progression. Further chemotherapy~     does not normally lead to a cure or dramatic improvement in the disease and there is a need~     to identify new drugs that are beneficial for these patients without unacceptable side~     effects. Prodrug chemotherapy is an approach in which an inactive non-toxic agent is~     administered to the patient and gets activated within the body at specific locations,~     resulting in a higher concentration of the cytotoxic form at a tumour location whilst~     avoiding general side effects. G-202 is an example of prodrug chemotherapy. It does not have~     many general side effects because it is converted to a cell toxin only at the tumour or other~     specific locations in the body. G-202 is activated by Prostate Specific Memory Antigen~     (PSMA), a substance expressed by prostate cancer cells and in the blood vessels of most solid~     tumours, but not by normal cells or blood vessels in normal tissue. It is believed that~     activation of the prodrug G-202 will allow the drug to kill cancer cells, particularly~     prostate cancer cells. This study will evaluate the activity and safety of G-202 in men with~     castration-resistant prostate cancer (CRPC), which means the cancer has progressed after~     hormone blocking treatment, but who have not yet received chemotherapy and who have no or~     only a few symptoms from their CRPC. The study will evaluate clinical activity and safety of~     G-202 administered on three consecutive days of a 28-day cycle.~   "
140016|NCT01734668|"~     The objective of this study is to demonstrate the clinical performance of the Sofia RSV FIA~     with specimens from symptomatic pediatric subjects who are less than nineteen (19) years of~     age.~   "
140017|NCT01734655|"~     The Specific Aim of this supplemental project is to evaluate the Mindful Eating Questionnaire~     (MEQ) to determine if it is a valid instrument for pregnant women. During this project, the~     MEQ will be qualitatively evaluated in a sample of pregnant women who are similar in age,~     ethnicity, education, and marital status to the women targeted for recruitment in the parent~     study. The qualitative evaluation will include a focus group with 10 participants followed by~     30 individual cognitive interviews. Comments from the interviews will be summarized and~     analyzed systematically for each of the 28 questions of the MEQ and the interviewer will use~     findings from initial interviews to inform subsequent interviews. Content validity will be~     evaluated based on responses from the focus group and cognitive interviews, and MEQ items~     will be evaluated for comprehension, retrieval, judgment, and response. Strengths,~     weaknesses, relevance, comprehensiveness, and interpretations will be reported for each of~     the MEQ questions. We will also have some of the more traditional validation parameters (the~     inclusion of other questionnaires) in the study to collect data on convergent and~     discriminant validity. The resulting publication will provide readers with a thorough report~     on the utility and appropriateness of using the MEQ to quantify mindful eating in pregnant~     women.~   "
140018|NCT01734642|"~     A medication error is a failure in the treatment process that leads to, or has the potential~     to lead, to harm to the patient.1 Medication errors are a common unfortunate occurrence in~     hospital. They can occur in different phases of the therapeutic process (prescribing,~     distribution, administration and monitoring) and have significant impact on morbidity and~     mortality. Prescribing faults and prescription errors are major problem among medication~     errors .Prescription errors account for 70 % of medication errors that could potentially~     result in adverse drug effects.2 Overall it has been estimated prescription errors affect 7 %~     of medication orders, 2% of patient days and 50 % of hospital admissions.3,4 When harm arises~     from a medication error it is potentially preventable. The medication errors project was~     devised to analyze and limit through educational audit and other tools, as much as possible,~     damages due to the therapeutic process. The project will include 5 phases. Preliminary phase:~     organizational meetings. Phase I: Patient monitoring: a monitor in collaboration with health~     professionals of involved units will review all patient charts and will register all adverse~     drug reactions(ADRs). All ADRs will be introduced by the monitor in a database. Health~     professional will be invited to send the reports of observed ADRs. Evaluation of ADRs : a~     panel of experts will evaluate if the ADRs are due to medication errors or not. Phase II~     :educational audits directed to health professionals will be organized. Tools to reduce the~     medication errors will be proposed. Phase III: the same procedure of the first phase. Final~     phase (IV): analysis of data with publication of a scientific article.~   "
140062|NCT01734070|"~     The goal of this study is to examine if chronic cherry consumption will decrease lipid~     peroxidation and serum concentration of inflammatory markers in human subjects with elevated~     serum C reactive protein (CRP), and to examine the relationship between serum concentrations~     of CRP and polyphenols. The investigators hypothesize that cherry consumption will reduce~     serum concentration of inflammatory markers, including CRP, inflammatory cytokines and~     adhesion molecules.~   "
140063|NCT01734057|"~     The project was undertaking by Qilu Hospital of Shandong University and other 13 well-known~     hospitals in China. In order to report the efficacy and safety of Recombinant Human~     thrombopoietin combining with Rituximab for the treatment of adults with primary immune~     thrombocytopenia (ITP), compared to conventional high-dose dexamethasone therapy.~   "
140019|NCT01734629|"~     Several studies show an association between chronic obstructive pulmonary disease (COPD) and~     coronary artery disease (CAD). Besides risk factors such as smoking, both are associated with~     physical inactivity, advanced age and systemic inflammation The use of coronary computed~     tomography (CCT) with multiple detectors is a diagnostic method for coronary disease,~     describing the anatomy and severity of arterial obstruction. One way of estimating the~     cardiovascular risk is coronary calcium score (CCS). Due to the association between COPD and~     CAD, it is likely that many patients with IHD diagnosed by CT have reduced lung function.~      The aim of this observational study is to establish the correlation between the CCS and lung~     function. It will also correlate the presence of irreversible airway obstruction with~     significant coronary lesions.~      Patients over 40 years referred to CCT who agree to participate in the study will perform a~     spirometry with bronchodilator and collect a blood sample to measure serum markers of~     inflammation and cardiovascular risk (glycemia, lipid profile, C reactive protein (CRP),~     tumor necrosis factor-alpha (TNF-Alpha) and fibrinogen). The data will be compared in the~     general population and in subgroups: smokers, former smokers and nonsmokers.~      One year after the CCT patients will be contacted by the investigators and accessed for~     emergency room visits, hospital admissions and fatal or nonfatal coronary or respiratory~     events.~      The investigators hypothesis is that reduced lung function is independently associated with~     elevated CCS and is, also a risk factor for increased hospital admission and coronary events.~      The concomitant assessment of lung function and CCS can contribute knowledge about the~     epidemiological association between pulmonary disease and CAD. This can also add to evidence~     for the use of spirometry as a marker of cardiovascular risk.~   "
140020|NCT01734616|"~     With age, muscles tend to waste at 0.5-1% per year, so that an 80 year old may have only 70%~     of the muscle possessed at 50. Muscle loss makes it harder to carry out tasks that require~     strength, keep the body balanced and continue activity for a prolonged period, which together~     may contribute to a loss of independence and an increased risk of falls. The cause of some of~     this muscle loss with ageing appears to be a reduction in muscle building in response to~     food. The known decreased limb blood flow in ageing muscle may go some way to explain this as~     there may be less nutrient delivery to the muscles. The investigators want to test if the~     known decrease in limb blood flow with age is matched with a decrease in the proportion of~     blood being delivered directly to the muscles, rather than fat and connective tissue. If so~     the investigators expect to see an improvement in the ability of muscles to maintain~     themselves via better capture of amino acids into protein. The investigators also want to~     test if 20 weeks resistance exercise training or drinking a cocktail of mixture of high~     flavanol cocoa (which can increase blood flow) and vitamin C can improve limb blood flow to~     older muscles and help reduce muscle wasting.~   "
140021|NCT01734603|"~     Rehabilitation is the first intention treatment of peripheral arterial disease (PAD) with~     claudication. Initially proposed in the sixty's, rehabilitation programs dedicated to~     patients with PAD have recently been proved effective and defined in many guidelines.~     Supervised walking training on treadmill is recommended. Usually patients walk up to a mild~     or moderate pain (evaluated at 3 or 4 on the claudication pain scale; maximum pain =5), then~     stop until pain completely subsides and walk again .~      The Artex study assesses the efficacy of a fractionated mode of training avoiding pain by~     alternating short sequences of intensive training and active recovery (without rest).~   "
140022|NCT01734590|"~     Exploratory study with double-blind, randomized, placebo-controlled, full cross-over design.~      The main objective is to identify one or two flour compositions in a carbohydrate-based food~     that produce a significant difference (alpha =0.2) in the time to reach 50% of cumulative~     absorption of exogenous glucose compared to the control.~   "
140023|NCT01734577|"~     Intramuscular therapy (also known as dry needling) has been shown to give dramatic relief of~     musculoskeletal pain. The mechanisms of action remain unknown, and this study will examine~     for a neurophysiological effect.~   "
140024|NCT01734564|"~     In this phase II study, patients with solid tumors will receive treatment with hiltonol and~     autologous dendritic cells.~   "
140025|NCT01734551|"~     The purpose of this study is to compare two different medicines to treat babies with opiate~     withdrawal. The treatment medicines are morphine, which is an opiate, and clonidine, a~     non-opiate. Morphine is a narcotic medicine, with is included in most pain killers. Clonidine~     is another drug, but is different from morphine. It is also used for babies, and even adults~     for withdrawal symptoms. Both drugs are effective, but the purpose of this study is to see if~     one may be better than the other.~   "
140026|NCT01734538|"~     The biological membranes that surround a cell and its organelles are important to the overall~     function of the cell. Fatty acids are the main structural components of a membrane, and the~     presence of certain fatty acids can alter a membrane's characteristics, which subsequently~     alters its function. Two fatty acids that are of particular interest to researchers are~     eicosapentanoic acid (EPA) and docosahexanoic acid (DHA). These omega-3 fatty acids have~     unique unsaturated structures, and their incorporation into biological membranes appears to~     elicit potent physiological effects. The body is unable to intrinsically synthesize these~     important fatty acids, so they must be obtained from the diet or through supplementation.~      EPA and DHA supplementation has been reported to provide numerous positive health benefits,~     including decreased blood pressure and an improved blood lipid profile. Recent research in~     our laboratory has demonstrated in young men that resting metabolic rate was increased~     following a 12 week period of omega fatty acid supplementation of 3 g/day. Fat utilization~     was also increased and carbohydrate use was decreased both at rest and during a 1 hr moderate~     exercise challenge. These findings have positive implications for people who are interested~     in losing weight, but it not known whether these effects occur in older adults. With age,~     body composition changes (increase in fat mass and decrease in lean mass) occur which may~     negatively affect general health, particularly normal physical functioning and quality of~     living of the older adult. The potential role of omega 3 fatty acids to increase fat~     oxidation and increase resting metabolic rate may be a therapy for decreasing fat mass in the~     older adult. Research has suggested that omega 3 fatty acids may elicit an additional~     therapeutic role by reducing joint pain.~      Another aspect of aging is a loss in lean body mass, which is associated with an attenuation~     of skeletal muscle protein synthesis in response to nutritional stimuli (amino acids and~     insulin). The weakened anabolic response is considered to be partly due to defects in the~     anabolic signaling cascade in the muscle. Research in older adults has reported an increase~     in muscle protein signaling with EPA and DHA supplementation in response to a nutritional~     challenge. However it is unknown whether the increase in protein signaling results in an~     eventual increase in lean body mass. The physical functioning of older adults is not only~     influenced by body composition changes, but also age-related neuronal changes that affect the~     velocity of axonal conduction and influence the ability of the muscle to generate torque and~     the rate at which the torque is developed. Muscular strength and functional capacity~     increases have been reported with chronic resistance exercise in a cohort of older women~     supplemented with EPA and DHA. However, the effect of EPA and DHA intake on physical strength~     in older adults with previously low EPA and DHA consumption, independent of exercise, is~     currently unknown.~      Therefore, the purpose of this study is to determine the effects of 12 weeks of omega-3~     supplementation at 3 g/day on metabolic and physical health parameters in community-dwelling~     older adults. We hypothesize that EPA and DHA supplementation will result in 1) a decrease in~     resting heart rate and blood pressure; 2) a more healthy blood profile; 3) an increase in~     resting metabolic rate; 4) a greater reliance on fat oxidation for energy both at rest and~     during exercise; and 5) a decrease in fat mass; and 6) an increase in lean mass, strength and~     physical function.~   "
140027|NCT01734525|"~     This is a prospective study aimed at testing a strategy of early initiation of an antifungal~     agent to patients admitted to intensive care units (ICUs) at risk for invasive candidiasis.~     Score system have been developed to identify groups at very high risk for the development of~     candidemia/invasive candidiasis in the ICU. These scoring system have used clinical~     information with or without data on Candida colonization, and have shown reasonable~     correlation with candidemia/invasive candidiasis. More recently, a biomarker - detection of~     1,3-beta-D-glucan in the serum - has been tested in the early diagnosis of candidiasis. The~     incorporation of biomarkers such as beta-D-glucan could help clinicians to select a group at~     higher risk for candidemia, and despite the fact that these tests may give false-positive~     results, their negative predictive value could be of great help. Likewise, analyzing the~     kinetics of these biomarkers in patients with candidemia/invasive candidiasis would help to~     define their usefulness in monitoring treatment.~      Therefore, the objectives of this study are:~        1. To assess the frequency of positive biomarkers in ICU patients at high risk to develop~          invasive candidiasis/candidemia;~        2. To evaluate the kinetics of positive biomarkers after initiation of antifungal therapy~          in patients with candidemia;~        3. To test the strategy of early discontinuation of antifungal therapy based on repeatedly~          negative blood cultures and 1,3 beta-D-glucan in the serum.~   "
140028|NCT01734512|"~     This is an open label study of everolimus in children with recurrent or progressive low-grade~     glioma.~   "
140029|NCT01734499|"~     This study is proposed to assess long-term Quality of Life issues in breast cancer survivors~     by measuring the impact on the quality of life made by the structured Change Cycle Work~     Shop coping class as compared to current local standard of care programs. It has been shown~     that breast cancer treatment can have long-term bio-psychosocial consequences. Specific~     evidence-based interventions are needed to address Quality of Life concerns in order to~     improve the overall outcome of breast cancer and its treatment beyond the focus on mortality~     rate.~   "
140030|NCT01734486|"~     This trial is conducted in Europe. The aim of the trial is to evaluate growth response of two~     somatropin dose regimens in girls with Turner Syndrome.~   "
140157|NCT01732770|"~     This study will compare the effectiveness of denosumab treatment every 6 months with once~     yearly zoledronic acid treatment on bone mineral density (BMD) at various skeletal sites.~   "
140031|NCT01734473|"~     Weight loss commonly occurs in patients with COPD, negatively influencing their quality of~     life, treatment response and survival. Loss of muscle protein is generally a central~     component of this weight loss and independently increases mortality. This study will provide~     relevant clinical information in regards to the anabolic properties of specific dietary~     substrates and their co-active anabolic effects. Hypotheses: 1) That supplementation of a~     hydrolyzed casein-based protein meal with the addition of carbohydrates is more anabolic than~     a hydrolyzed casein-based protein meal without carbohydrates in COPD patients and healthy~     older adults; 2) That leucine addition to a hydrolyzed casein-based protein meal only~     enhances the protein anabolic response in COPD patients and healthy older adults when~     carbohydrates are not added to the protein meal; 3) That COPD patients have a more efficient~     protein anabolic response to a hydrolyzed casein-based protein meal than healthy older~     adults.~      A fifth study day was added to measure protein requirements of included individuals to be~     able to interpret their response to the other interventions on the other study days, and to~     test the hypothesis that subjects with lower protein requirements respond less to~     intervention with leucine and/or carbohydrates. For the 5th additional test day we will first~     approach the 10 COPD and 10 healthy subjects who already completed the first 4 study days~     (and signed the re-contact form) to come back for this extra test day. We will (pre-)screen~     these subjects by phone for eligibility and check for changes in their recent medical history~     (with help of the (pre-)screening questionnaires in CRF). If all inclusion criteria are still~     met, these subjects will be asked to provide a written re-consent. If necessary, we will~     recruit new subjects who will complete only one of the four test days (i.e. the test day on~     which the hydrolyzed casein-based protein meal with carbohydrates is provided) and the~     additional 5th study day.~   "
140032|NCT01734460|"~     Sleep disordered breathing (SDB) is a common condition affecting up to 9% of adults with~     serious neurocognitive, metabolic and cardiovascular consequences that has a significant~     impact on public health. Evidence indicates that the physiologic changes occurring during~     pregnancy, particularly during the third trimester, increase the risk of those women to~     develop SDB. As in the general population, SDB during pregnancy is more frequent among obese~     women. In the light of the increasing prevalence of obesity among females of reproductive~     age, SDB may thus have an increasingly significant impact on women's and children's health by~     contributing to the adverse maternal and fetal outcomes associated with maternal obesity.~      Only a limited amount of data is available on the consequences of maternal SDB during~     pregnancy. Even less information is available on the effect of maternal SDB on fetal growth~     and development. The current proposal is designed to specifically explore the effect of~     maternal SDB on fetal growth.~      It has been suggested that fetal growth as reflected in birth weight is a strong correlate~     for conditions occurring in the intrauterine environment with potential long lasting~     influence on a child's health.~      Our overall hypothesis is that the intermittent hypoxia, sleep fragmentation and the~     metabolic alterations associated with maternal SDB will affect fetal growth.~      Using a variety of methods and a multidisciplinary approach, we will explore the following~     objectives: 1) The effect of maternal SDB on fetal growth ; 2) To explore mechanisms that may~     underlay the effect of maternal SDB on fetal growth 3) To explore the long term (first 3~     years of life) effect of maternal SDB on a child's growth.~      The results of this study will make an important contribution to the fields of women and~     children's health. It will provide better insight into the mechanisms by which disrupted~     maternal sleep affects fetal growth.~      We expect that the findings from our study will enable the defining of a new treatable~     clinical entity or syndrome: the infant of the gestational SDB mother, for which early~     diagnosis and intervention might be of major importance to the newborn infant.~   "
140033|NCT01734447|"~     This trial is conducted in Europe. The aim of this trial is to assess the safety of long-term~     growth hormone treatment in growth-retarded children with intrauterine growth retardation~     (IUGR) enrolled in trial GHRETARD/F/1/F.~   "
140034|NCT01734434|"~     This study will collect information regarding the factors that might influence access of~     pregnant women to the local healthcare system. The main visits of the study will be screening~     & enrollment, delivery and 90 day infant follow-up. Data will be collected mainly from~     questionnaires administered to pregnant women at these visits. The questionnaires contain the~     following standard questions which will be asked at each visit, in addition to some~     visit-specific questions related to delivery and health status of infants up to 90 days of~     age. The standard questions will be related to the following aspects:~        -  Logistics of transportation to the study site (type, time it takes, cost incurred)~        -  Accessibility to a telephone/cell phone~        -  Provisions of alternative child care during site visits if there are other children~          under the subject's care~   "
140035|NCT01734421|"~     AIM: To assess the efficacy of an intervention based on the specific design and~     implementation of a mobile application (APP) in order to reduce the prevalence of smoking~     consumption among young people motivated 18 to 30 years METHODS: Cluster randomised clinical~     trial. Unit of randomization: Primary Health Care Centers (PHCC). Intention to treat~     analysis. STUDY POPULATION: Motivated young smokers of 10 or more cigarettes per day aged 18~     to 30 years consulting for any reason to PHCC and who provided written informed consent to~     participate in the trial.~      INTERVENTION: 6-month implementation of recommendations of a Clinical Practice Guideline~     smoking cessation which includes mobile APPs application. Control group: usual care. OUTCOME~     MEASURES: Abstinence at 12 months confirmed by exhaled air carbon monoxide concentration of~     less or iqual 10 parts per million in each control.~      RESULTS: The application of a smoking cessation intervention with a mobile APPs application~     will improve the smoking cessation success rate in smokers, besides of their intention or not~     to give up smoking at baseline.~   "
140036|NCT01734408|"~     Hand, foot, and mouth disease (HFMD) is a common viral illness in infants and children caused~     by viruses that belong to the enterovirus genus of the picornavirus family. Although most~     HFMD cases do not result in serious complications, outbreaks of HFMD caused by enterovirus 71~     (EV71) can present with a high rate of neurological complications, including~     meningoencephalitis, pulmonary complications, and can even cause infant death. HFMD caused by~     EV71 has become a major emerging infectious disease in Asia and the highly pathogenic~     potential of EV71 clearly requires the attention of world medical community.~      The phase II study of inactivated vaccine (vero cell) against EV71 has completed last month~     in Jiangsu Province in China. The data from the phase II study suggested that the inactivated~     EV71 vaccine had a clinically acceptable safety and good immunogenicity for healthy Chinese~     children and infants. But the antibody titer against EV71 was found decreased significantly~     at month 8 compared to that at day 56. Considering the similar dynamic trend had also been~     found in the antibody against poliovirus induced by polio vaccines, and whose immunization~     schedule contains a booster dose administrated at 1 to 1.5 year after the first 3 doses of~     fundamental immunity. In order to find a better immunization schedule for children, the~     investigators decided to perform this booster immunity trial among these children who had~     received two doses of EV71 vaccines (around one year after the fundamental immunity). The~     investigators do the recruitment among these children who had participated in the previous~     phase II trial and received EV71 vaccines, and randomize them in a ratio of 2:1 to receive~     either a booster dose of EV71 vaccines or placebo.~   "
140037|NCT01734395|"~     The purpose of this study is to demonstrate that the change of attention measure is~     correlated with the changes of caregiver's burden after treatment with galantamine.~   "
140064|NCT01734044|"~     The project was undertaking by Qilu Hospital of Shandong University and other 13 well-known~     hospitals in China. In order to report the efficacy and safety of Recombinant Human~     thrombopoietin combining with Dexamethasone for the treatment of adults with primary immune~     thrombocytopenia (ITP), compared to High-dose Dexamethasone therapy.~   "
140038|NCT01734382|"~     PART1 Participants in Part 1 (Run-in-Phase) of study will receive Tocilizumab (TCZ)~     (RoActemra/Actemra) 12 milligrams per kilogram (mg/kg) or 8 mg/kg intravenously (IV) every 2~     weeks (Q2W) for up to 24 weeks. Participants who experience a laboratory abnormality during~     part 1 may be eligible to move into Part 2 of the study.~      PART 2 This open-label Phase IV study will evaluate the efficacy, safety, pharmacokinetics,~     pharmacodynamics and immunogenicity of RoActemra/Actemra (tocilizumab) in reduced dose~     frequency in participants with adequately controlled systemic juvenile idiopathic arthritis~     who have experienced a laboratory abnormality on twice weekly RoActemra/Actemra dosing, that~     has since resolved. Participants will receive RoActemra/Actemra 12 mg/kg or 8 mg/kg~     intravenously every 3 weeks. After 5 consecutive infusions, participants who experience an~     event of neutropenia, thrombocytopenia or liver enzyme abnormality will move to every 4 weeks~     RoActemra/Actemra administration. Anticipated time on study treatment is 52 weeks.~   "
140039|NCT01734369|"~     Background:~        -  Myositis is a rare disease in which the body s immune cells attack the muscle tissue. It~          can cause muscle weakness, swelling, and pain. It can develop in people with no history~          of muscle problems. Environmental exposures may determine who develops myositis. Genes~          may also affect development of the disease.~        -  Some people who serve in the military develop myositis. However, other military~          personnel do not. Researchers want to compare military personnel with and without~          myositis. They will look for common factors that might have led to the disease.~      Objectives:~      - To study environmental risk factors for myositis in military personnel.~      Eligibility:~        -  Military personnel who developed myositis during their period of service.~        -  Healthy military personnel who do not have myositis or another autoimmune disease.~      Design:~        -  Participants will have a physical exam and medical history.~        -  Participants will fill out forms about environmental exposures, particularly while in~          the military. The questions will ask about past infections, vaccines and medications,~          and personal habits. They will also ask about participants occupations during military~          service and their deployments.~        -  Participants will also provide blood samples for study.~        -  No treatment will be provided as part of this study.~   "
140040|NCT01734356|"~     The recent developments of research on iPS (induced pluripotent stem) cells lead to the~     establishment of mature cell lines such as cardiomyocytes or valvular interstitial cells with~     genetic and cellular characteristics of the donors. These cells represent a biological~     material more readily available to identify the pathophysiological mechanisms involved in the~     diseases of BrS or ERS patients, which will lead to the identification of genetic markers.~   "
140041|NCT01734343|"~     Age-related cataract is the main cause of impaired vision in the elderly population~     worldwide.~      The only treatment that can restore functional visual ability is cataract surgery where the~     opacified crystalline lens is removed by phacoemulsification and an artificial intraocular~     lens is implanted into the remaining capsular bag. Cataract operations are generally very~     successful, with a low risk of serious complications.~      The most common reason for impaired vision after uneventful cataract surgery in otherwise~     healthy eyes is the development of posterior capsule opacification (PCO). PCO is a~     physiological change (thickening, opacification and clouding) of the capsular bag expected~     after cataract surgery, because the lens epithelial cells (LECs) undergo hyperplasia and~     cellular migration. PCO is treated with Nd:YAG capsulotomy, a quick outpatient procedure that~     uses a laser to open a central hole in the posterior capsular bag.~      Modifications in IOL design and material lead to a decrease in the incidence of PCO.~      During the past two decades, refinements in surgical technique were made resulting in today's~     small incision phacoemulsification surgery. Nowadays a multitude of microincision IOLs are~     available, many of them similar but of course with some differences in regard to the chemical~     composition of the acrylic material and the IOL design.~      The purpose of this study is to compare the development of posterior capsule opacification~     (PCO) and the frequency of treatment between two different microincision IOLs over a period~     of 3 years.~   "
140042|NCT01734330|"~     Background: Pharmacological strategies to improve smoking cessation have been largely~     studied. The efficacy of cognitive behavior therapy associated to nicotine replacement in~     tobacco cessation has not yet been demonstrated.~      Objective: Evaluate if cognitive behavior therapy during six weeks associated to nicotine~     replacement for twelve weeks is able to contribute to tobacco cessation at the end of 52~     weeks.~      Methods: Multicentre, open-label, and pragmatic randomized controlled trial will include 334~     patients. Analysis will follow intention-to-treat principle.~      Patients older than 18 years old and who had smoked at least 5 cigarettes in the past year~     before randomization will be included.~      All of them will receive nicotine replacement therapy with patches and gum. They will be~     randomized 1:1 ratio to attend or not cognitive behavior therapy once a week for the first~     six weeks of the treatment. Every two weeks all of the patients will be evaluated by a~     physician in order to access any adverse effects from the nicotine replacement.~      All patients will have carbon monoxide levels accessed at baseline and after 6 weeks.~     Telephonic interview will be done at 16, 28, and 52 weeks to access the rates of tobacco~     cessation, relapses episodes and abstinence maintenance.~   "
140043|NCT01734317|"~     Approximately 10 subjects from one clinic having sustained a burn injury covering 1-25% or~     the Total Body surface Area (TBSA)and assessed as superficial partial-thickness or~     superficial deep-partial-thickness. The subject will be assessed once a week for a maximum of~     3 weeks or until the burn is healed if that occurs earlier. . The dressing Mepilex Transfer~     Ag will be used as wound contact layer and gauze rolls and compression as second dressing.~   "
140044|NCT01734304|"~     The aim of this study is to determine the feasibility and safety of an autologous DC~     immunotherapy in patients with AML of non-favorable risk profile.~   "
140045|NCT01734291|"~     The purpose of this study is to examine the effectiveness of brief multifamily~     psychoeducation to relieve the psychological distress of families of patients with chronic~     major depression and to improve their family functioning.~   "
140046|NCT01734278|"~     The purpose of this observational study is to evaluate the use and short term safety of~     Asenapine (Sycrest) in real-life usage in the Mental Health Trust Setting in the United~     Kingdom(UK) National Health Service (NHS). The study is to be carried out independently by~     the Drug Safety Research Unit (DSRU) in Southampton, although it is funded by Merck, the~     manufacturer of Sycrest.~   "
140048|NCT01734252|"~     Critically ill patients with high risk for thrombosis or tromboembolic events with the~     presence of heparin resistance, treated at the Department for General and Surgical Critical~     Care Medicine of the Medical University Innsbruck, Austria will be enrolled in the study when~     meeting the inclusion- and exclusion criteria. If a patient meets the inclusion criteria and~     is recruited for the study, the patient will be randomized either to Group A or Group H.~      All patients have to achieve a prophylactic aPTT-target range of an aPTT-level of 45 - 60 sec~     (Pathromtin® SL) within 6 to 8 hours.~      Randomisation Group A:~      If a Heparin resistance appears and the patient meets the inclusion and exclu-sion criteria,~     he/she will be enrolled. The Heparin administration will be stopped and Argatroban will be~     given and adjusted until the target aPTT-range is achieved.~      Randomisation Group H - Standard therapy:~      If a Heparin resistance appears and the patient meets the inclusion and exclu-sion criteria,~     he/she will be enrolled. The Heparin administration will be contin-ued and, if necessary~     increased. Hereby the maximum heparin dose is 1.500 IU per hour.~      Therapy failure Group H:~      Primary target failure at Visit 3 (6-8 hours):~      If a patient of Group H does not achieve the target-aPTT within 6-8 hours, he/she will switch~     to Group A and will start with T1 (Baseline) and will follow the visits according to Group A~     until the final Visit 9 (T1 / day 30).~      Maintenance failure after Visit 3:~      Maintenance failure after 6-8 hours is defined as non-maintenance of the tar-get-aPTT until~     day 7 with a max. heparin dosage of 1.500 IU per hour. In this case, heparin therapy has to~     be changed to Argatroban.~      The patient will start with T1 (Baseline) and will follow the visits according to Group A~     until the final Visit 9 (day 30) counting from the Baseline of Group A.~      Therapy failure Group A:~      If a patient of Group A does not achieve the target-aPTT within 6-8 hours or cannot maintain~     the target-aPTT in spite of reaching the maximum dosage of 10µg/kg/min during the further~     study period, the patient automatically drops out of the study.~      The same is effective for patients who switched to the Group A after a therapy failure in~     Group H.~      General:~      Two hours after starting the Baseline investigations, patient's parameters in-cluding blood~     collections will be measured for the second time (T2). Additional measurements will be made~     at 6-8 hours (T3), 24 hours (T4), 48 hours (T5), 5 days (T6) after start of study drug and on~     day 7 before (T7) stop of study medication and 6h (T8) after stop of study medication. 30~     days after inclusion in the study, a final investigation is planned (T9).~   "
140049|NCT01734239|"~     The purpose of this study is to determine if Pneumovax™ 23 (V110) is safe and immunogenic in~     participants from the Russian population who are 50 years of age and older or 2 to 49 years~     of age and at increased risk for pneumococcal disease~   "
140050|NCT01734226|"~     The investigators performed a 8-week, randomized, double-blind, placebo-controlled human~     trial to evaluate the efficacy and safety of Prunus Mume Extract on Improvement of~     Constipation. The investigators measured Improvement of Constipation parameters , including~     Colonic Transit Time, number of bowel movement, defecation time, stool type, color and stool~     amounts per defecation, and monitored their blood pressure.~   "
140051|NCT01734213|"~     The investigators performed a 12-week, randomized, double-blind, placebo-controlled human~     trial to evaluate the efficacy and safety of Eriobotyra Japonica Lindley Extract on~     improvement of Cognitive Function. The investigators measured improvement of Cognitive~     Function parameters , including K-MMSE, Ability to perform working memory tasks, CNT and~     BCRS, and monitored their blood pressure.~   "
140052|NCT01734200|"~     The investigators performed a 12-week, randomized, double-blind, placebo-controlled human~     trial to evaluate the efficacy and safety of Eriobotyra Japonica Lindley Extract on~     improvement of Memory Function. The investigators measured decrement of improvement of Memory~     Function, including K-MMSE, Rey-Kim Memory Test, BCRS, and PRMQ, and monitored their blood~     pressure.~   "
140053|NCT01734187|"~     The investigators performed a 12-week, randomized, double-blind, placebo-controlled human~     trial to evaluate the efficacy and safety of Fermented Cinnamon Vine Powde on decrement of~     body fat. The investigators measured decrement of body fat parameters , including abdominal~     fat, Body Fat Mass, LDL-C, HDL-C, Total Cholesterol and triglyceride, and monitored their~     blood pressure.~   "
140054|NCT01734174|"~     Echocardiography is an ultrasound-based imaging technique which can be performed through the~     esophagus (which lies behind the heart) and through the chest wall; both TEE and TTE are~     performed routinely as a monitoring and diagnostic tool at different times in the course of~     one cardiac surgery. The purpose of the study is to compare these two methods of~     echocardiography and comparing them to the 2D TEE and TTE assessments, which are routinely~     performed simultaneously. The study will also compare the echocardiography data to a third~     technique, thermodilution, which measures cardiac function via a pulmonary artery catheter.~   "
140055|NCT01734161|"~     Patients who present for scheduled (non-emergent) cesarean section will be given either~     intravenous dexamethasone or placebo prior to receiving a duramorph containing spinal~     anesthetic. The investigators will then compare the incidence of nausea and vomiting and the~     use of rescue anti-nausea medications in both groups. Our hypothesis is that patients~     receiving dexamethasone prior to duramorph containing spinal anesthesia for cesarean section~     will have a significantly lower incidence and severity of PONV at 0, 1, 3, 6, and 24 hours~     following surgery.~   "
140056|NCT01734148|"~     Sleep is a biological process essential for health. Being hospitalized can exacerbate common~     sleep difficulties in children. Factors that contribute to sleep disturbances during~     hospitalization include environmental, physiological, and psychological factors. Although~     sleep interventions exist for healthy children in the community, interventions aimed at~     hospitalized children need to be developed and piloted with rigorous evaluative methods. The~     primary purpose of this study is to examine the feasibility and acceptability of the RELAX TO~     SLEEP program on hospitalized children. Although this study is a pilot study, comparisons~     will be made to examine sleep outcomes between the intervention group and the control group~     including: total nocturnal (19h30-07h29), number of nighttime awakenings, longest stretch of~     nocturnal sleep, and total daytime (07h30-19h29) sleep. Other comparisons include anxiety~     levels and the development of post-hospital maladaptive behaviours.~   "
140057|NCT01734135|"~     This proposal examines use of a clinical reminder to the primary provider of patient with a~     high B type natriuretic peptide but no prior imaging.~      Electrical Medical Record-based Intervention to Determine whether Clinical Reminders Improve~     Heart Failure Management in Patients with High BNP Values and Unknown LVEF.~   "
140058|NCT01734122|"~     The purpose of this study is to determine the changes in quality of life and degree of tremor~     for patients with essential tremor or Parkinsonian tremor who are treated by stereotactic~     radiosurgery (SRS). This is a questionnaire-based study. Please see Detailed Description~     below for more information.~   "
140059|NCT01734109|"~     Negative-pressure wound therapy (NPWT) is an important adjunct for management of wounds, and~     promotes granulation tissue and angiogenesis. Despite these known means for facilitation of~     wound management, further research is needed to examine whether this modality is superior to~     other currently used options, thus defining clear indications for and benefits of NPWT. This~     would also help establish the role of combination therapy, using NPWT with simultaneous~     irrigation or other forms of dressings. This study aims to compare treatment efficacy of~     NPWT, NPWT plus proprietary simultaneous irrigation, and traditional hospital standard of~     care for treatment of grade III & IV pressure ulcers. Primary endpoint of this study is~     comparison of reduction of wound volume between the three treatment arms; and secondary~     endpoints include bacterial load, rate of wound healing, preparation for grafting, and pain.~   "
140065|NCT01734018|"~     This multicenter, prospective, observational study will evaluate the efficacy and safety of~     Pegasys (peginterferon alfa-2a) in routine clinical practice in patients with HBeAg-positive~     or HBeAg-negative chronic hepatitis B. Eligible patients receiving treatment with Pegasys~     according to standard of care and the summary od product characteristics/local labelling will~     be followed for the duration of treatment and up to 2 years of follow-up.~   "
140066|NCT01734005|"~     The investigators performed a 12-week, randomized, double-blind, placebo-controlled human~     trial to evaluate the efficacy and safety of red ginseng on decrement of body fat. The~     investigators measured decrement of body fat parameters , including Body Fat Mass, Percent~     Body Fat, weight and BMI(body mass index), and monitored their blood pressure.~   "
140067|NCT01733992|"~     The purpose of this study is to determine the safety, tolerability and pharmacokinetics of~     R348 eye drops in patients with dry eye disease.~   "
140068|NCT01733979|"~     The investigators performed a 4-week, randomized, double-blind, placebo-controlled human~     trial to evaluate the efficacy and safety of Heme-Iron Polypeptide on Improvement of Anemia.~     The investigators measured Improvement of Anemia parameters , including hemoglobin,~     transferrin saturation, serum iron, and ferritin, and monitored their blood pressure.~   "
140069|NCT01733966|"~     The primary outcome measure is to compare efficacy of an association of~     Secnidazol(2g)-Ciprofloxacin(1g) (during 3 days) versus 3g of Amoxicillin-Clavulanic Acid~     during 10 days for the Treatment of Uncomplicated Episode of Diverticular Sigmoïditis Among~     Adults in clinical and biological cure.~      The cure rate will be evaluated at the second visit (14 days after the inclusion visit)~   "
140070|NCT01733953|"~     Adult survivors of childhood cancer are at high risk of developing cardiovascular disease.~     Therapies used to treat many cancers, such as chemotherapy and radiation, likely cause damage~     to the surface of the artery wall called the endothelial layer, leading to the induction of~     atherosclerosis and eventual cardiovascular disease. HMG coenzyme A reductase inhibitors, or~     statins, improve endothelial function independent of cholesterol-lowering. In addition,~     statins have been shown to reduce arterial stiffness and slow arterial thickening. Despite~     strong evidence supporting the vascular benefits of statins in many different patient~     populations, these medications have never been studied in cancer survivors. Therefore, the~     overall objective of this study is to evaluate the effects of statin therapy on vascular~     health in young adult survivors of childhood cancer.~      Twenty-four young adult (age 18-39 years old) survivors of childhood acute lymphoblastic~     leukemia (ALL) or non-Hodgkin's lymphoma (NHL) will be enrolled in a six-month randomized,~     double-blind (participants and investigators), placebo-controlled pilot clinical trial~     comparing the effects of atorvastatin versus placebo on endothelial function and other~     measures of vascular health.~      Our primary objective is to evaluate the effects of 6-months of statin therapy on conduit~     artery endothelial function in young adult survivors of childhood cancer. The investigators~     hypothesize that, compared to placebo, atorvastatin will significantly increase brachial~     artery flow-mediated dilation in survivors of childhood acute lymphoblastic leukemia and~     non-Hodgkin's lymphoma.~   "
140071|NCT01733940|"~     Introduction: The vascular catheter-related bacteremia (BRC) is a major health problem in~     intensive care units. The use of dressings containing chlorhexidine gluconate (CHG) can~     decrease the catheters colonization, closely related to infection thereof.~      Objective: To determine the efficacy of the dressing Tegaderm CHG dressings versus~     Tegaderm IV dressings in reducing the risk of colonization of central intravascular~     catheters in the intensive care unit (ICU).~      Methods: Randomized controlled trial with blinding professional who reviews the main outcome.~     The study included patients over 18 years, indicating the central intravascular catheter~     implantation in the ICU or in the operating room, prior informed consent. Excluding subjects~     with positive blood culture at the time of catheter implantation.~      The estimated sample size is 398 patients, with a confidence level of 95% and a statistical~     power of 80%. The study protocol was approved by the ethics committee of the hospital.~      Be made prospectively followed subjects from study entry until catheter removal collecting~     information on age, sex, APACHEII, antibiotic therapy, duration of catheter insertion site~     and removal, reason for withdrawal and microbiological information.~      For statistical analysis, a model is adjusted multivariate logistic regression, determining~     the interaction of variables with the likelihood ratio test and confusion by switching~     between the crude and adjusted effect greater than 10%.~      Results and conclusions: The recruitment has started in November 2012 and is scheduled for~     completion in March 2013. This study will determine whether these new dressings are effective~     in our environment.~   "
140072|NCT01733927|"~     The purpose of this study, conducted in Santiago-Chile, was to:~        1. Evaluate the sensitivity and specificity of OraQuick Advance oral rapid test (OQA)when~          compared to ELISA;~        2. Track the number of people in the study who returned for their ELISA test HIV results;~          and~        3. Analyze the perception among participants of the use of OQA compared to ELISA testing~          for HIV screening.~   "
140073|NCT01733914|"~     According to traditional Chinese medical theories, a variety of acupuncture formulas can~     treat diseases such as pain. For example, stimulating acupoints either local or distal to the~     pain site has been proposed under some conditions. We hypothesize that stimulating acupoints~     contralateral to the pain site can successfully treat chronic shoulder pain.~   "
140074|NCT01733901|"~     To study whether renal sympathetic denervation(RSD) will reduce the all-cause mortality and~     the recurrence rate of a composite of cardiovascular event(including angina, myocardial~     infarction, repeat percutaneous coronary intervention and coronary artery bypass grafting) in~     patients after percutaneous coronary intervention(PCI). Besides whether RSD can reduce the~     risk factors for coronary heart disease.~   "
140103|NCT01733524|"~     The investigators' long-term goal is to discover novel, inexpensive and feasible strategies~     to improve the management and well-being of youth with T1DM. The specific objective of this~     proposal is to quantify the impact of responsible pet ownership on the glycemic control and~     health related quality of life in youth with T1DM.~   "
140104|NCT01733511|"~     Emergency departments are established in 20 hospitals in Denmark in order to improve the~     quality for the acute patients.~      A group of acute patients which require timely assessment and plan from a specialist is~     patients with abdominal pain.~      the aim of the present study is to evaluate whether the admission of the group of patients to~     emergency departments reduces the time to doctor, specialist and plan compared to the~     traditional admission to a surgical acute ward.~   "
140075|NCT01733888|"~     Dental fluorosis is a clinical manifestation of chronic exposure to high intakes of fluoride~     during the tooth development.~      The present study is planned to evaluate the efficacy of Resin Infiltration technique in~     improving the esthetics of non-pitted fluorosis stains on permanent anterior teeth. Resin~     infiltration is a novel method that has shown its efficacy in improving the esthetics of~     White spot lesions (WSLs) per say and post orthodontics WSLs in different both in-situ and~     in-vivo studies. The Resin Infiltration technique is also known to stop the progression of~     caries in non cavitated lesions in both, smooth surface and interproximal lesions.~      Therefore, the following trial will be conducted to assess the esthetic improvement of~     fluorosed permanent anterior teeth after resin infiltration and compare it with standard~     bleaching procedure and a combination of bleaching and Resin infiltration therapy in children~     with damaged teeth by fluorosis.~   "
140076|NCT01733875|"~     To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single oral~     dose of CC-220 and to explore the effect of food on the bioavailability of CC-220 in healthy~     subjects~   "
140077|NCT01733862|"~     This study aims at assessing the impact of RV vaccination in hospitals in Nagoya City~     (administrative district), Japan, where RV vaccines have been introduced since November 2011~     and financial support for vaccination costs by Nagoya city, Japan have been implemented from~     October 2012.~   "
140078|NCT01733849|"~     This study aims to estimate the real situation of rotavirus gastroenteritis (RV GE) in the~     primary care settings of both Bulgaria and Latvia in children less than 5 years of age.~   "
140079|NCT01733836|"~     To determine whether the use of metformin in patients with low-risk prostate cancer can delay~     progression to clinically significant prostate cancer.~   "
140080|NCT01733823|"~     P16 negative cancers continue to have a dismal prognosis despite advances in the treatment of~     head and neck cancer. Acceleration, dose-escalation, hyperfractionation, chemotherapy and~     nimorazole has been shown to improve local control. The purpose of the study i to investigate~     the level of co-morbidity and performance status (PS) that allows the combination of all of~     the above means of treatment intensification~   "
140081|NCT01733810|"~     The purpose of this study is to determine the role of hypoxia inducible factor (HIF)-2a on~     the production of inflammatory cytokines that lead to reflux esophagitis.~   "
140082|NCT01733797|"~     The trial will compare exercises using Therabite® versus wooden spatulas to prevent or~     relieve trismus in patients with stage 3 and 4 oral/oropharyngeal cancer.~   "
140083|NCT01733784|"~     In obstructive sleep apnea (OSA), the upper airway recurrently closes during sleep. The~     mechanisms that lead to airway closure are not completely understood. Some studies have shown~     that there is progressive narrowing of the pharyngeal airway across breaths during expiration~     (Progressive Expiratory Narrowing, PEN) preceding an obstructive apnea. The investigators~     will assess the viscoelastic properties of the pharyngeal airway and its role in PEN.~   "
140084|NCT01733771|"~     This study evaluates the effects of complementary medicine (CAM) treatments on patient~     reported outcomes in hospital settings, for hospitalized people. Various CAM modalities such~     as acupuncture, reflexology, guided imagery and hypnosis are evaluated. The investigators~     compare outcomes between two groups: Standard of care (treatments that are provided commonly~     in hospital) versus standard of care AND CAM treatments. Outcomes assessed are both~     quantitative i.e. scores on Visual Analogue Scale for various symptoms such as pain, nausea,~     wellbeing, anxiety, and qualitative such as Measure Yourself Concerns And Wellbeing.~   "
140085|NCT01733758|"~     This study is designed to examine the efficacy and safety of 2 dose levels of weekly~     subcutaneously injected albiglutide compared with placebo and an open label reference arm of~     daily subcutaneous injections of liraglutide, in Japanese subjects with Type 2 diabetes~     mellitus.~   "
140086|NCT01733745|"~     The purpose of this study was to assess the efficacy of the SYSTANE® family of products~     (SYSTANE® Lid Wipes, SYSTANE® BALANCE Lubricant Eye Drops, and SYSTANE® Vitamins) on~     meibomian gland functionality in subjects with lipid deficiency related to evaporative dry~     eye as compared to the standard of care warm compresses.~   "
140087|NCT01733732|"~     The purpose of this study is to evaluate the ability of SYSTANE® BALANCE and SYSTANE® Gel to~     improve comfort in subjects with dry eyes.~   "
140088|NCT01733719|"~     LAY SUMMARY~      A type of gullet cancer (oesophageal adenocarcinoma) has become the 5th commonest UK cause of~     cancer death. Unfortunately, by the time patients have symptoms, the cancer is often~     incurable. People with Barrett's oesophagus (change of gullet lining occurring in some with~     acid reflux) at risk of this cancer can have regular check-ups, involving examination through~     an endoscope (an instrument inserted by mouth, under mild sedation if required). A small~     proportion of people with Barrett's develop further changes (which might become cancer) in~     the gullet lining; if they do, it is important to remove the affected tissue before cancer~     develops, or when it is at an early stage.~      There are several ways of removing this tissue but the investigators do not know which is~     best. The standard treatment is surgery, but there is a small risk of dying from the~     operation, and patients often suffer complications affecting them for a year or more~     afterwards. Two endoscopic treatments do not involve surgery. Both involve removing visible~     abnormalities by a technique called endoscopic resection, followed by cauterising the~     remaining Barrett's gullet lining by 1 of 2 techniques. One is recommended by the National~     Institute for Health and Clinical Excellence, but it is expensive and less widely available~     than the second. No-one has compared these treatments with each other, nor with surgery, in~     randomised trials (the most reliable way of deciding which is best). Patient groups say they~     would prefer to avoid surgery if the alternative works, and have encouraged us to do trials.~      This feasibility study is a vital step towards two trials: (a) a trial to compare the two~     non-surgical techniques and (b) a trial comparing surgery with endoscopic treatment. It will~     help us find out whether it will be possible to enroll and retain enough patients by using~     several centres, and to identify/resolve any other potential barriers to recruitment and~     retention, including exploring viewpoints of patients and surgeons.~   "
140089|NCT01733706|"~     The aim of this study is the evaluation of early smoking reduction or cessation by means of~     no nicotine electronic cigarette added to standard counselling.~   "
140105|NCT01733485|"~     Asthma is an inflammatory disease, which means it causes swelling in the lungs to cause~     shortness of breath and/or wheezing. There are several asthma medications that help to reduce~     this problem.~      The objective of this research study is to characterize the presence of electrophilic fatty~     acids in the bronchial airway of subjects with controlled asthma at baseline and after~     treatment with Aspirin, Indomethacin, or no treatment at all. The presence of electrophilic~     fatty acids may indicate inflammation. Aspirin and Indomethacin are known to respectively~     increase and inhibit the formation of electrophilic fatty acids. By gaining a better~     understanding of how electrophilic fatty acids work and how they respond to different~     treatment, researchers hope to be able to find better ways to lessen airway inflammation in~     asthma in the future.~   "
140090|NCT01733693|"~     The purpose of this study is to (1) compare the effects of buprenorphine and methadone, two~     types of opioid addiction treatment, on the ability to think and reason among people addicted~     to opiates, and who are either HIV negative or HIV positive; and (2) investigate whether HIV~     infection changes the way opioid treatment affects the ability to think and reason. The~     investigators hypothesize that there will be (1) significant improvement in thinking and~     reasoning ability after starting buprenorphine treatment compared to methadone treatment,~     among participants with and without HIV at 2 and 4 months compared to baseline; and (2) HIV~     positive participants will demonstrate significant improvement in thinking and reasoning~     ability at 2 and 4 months compared to baseline, but that their thinking and reasoning ability~     will still be lower than HIV negative participants.~   "
140091|NCT01733680|"~     The investigators are proposing to test a medication derived from our prior studies of the~     gene SLC9A9. This one gene makes NHE proteins that control how we learn and remember items,~     which is impaired in ADHD and may cause an inability to plan, prioritize,~     self-monitor,inhibit, initiate, self-correct, or control one's behavior. The investigators~     now propose to investigate the therapeutic utility of an NHE inhibitor, amiloride~     hydrochloride, for the treatment of attention deficit hyperactivity disorder (ADHD) in~     medication-naïve adults with ADHD.~   "
140092|NCT01733667|"~     The purpose of this study is to compare the safety and effectiveness of MediENT to MeroPack~     after FESS.~   "
140093|NCT01733654|"~     The purpose of the study is to explore the efficacy of 6 weeks treatment of an~     investigational medication, RO4995819, versus placebo as adjunctive therapy in patients with~     major depression.~   "
140094|NCT01733641|"~     Healthy volunteers without concussion, currently participating in non-or-limited contact~     sports teams at Emory University will undergo Display Enhanced Testing for Concussion and~     mild traumatic brain injury (mTBI) (DETECT) on three separate days: at baseline, day 50, and~     day 90. Prior to enrollment participants will be allocated to the test-retest arm or the~     exercise arm.~   "
140095|NCT01733628|"~     GEI-BEV-2011-02 is a multicenter, post-authorization observational with prospective follow-up~     (EPA-SP) study. Will be involved 137 metastatic breast cancer patients or metastatic~     colorectal cancer. The hypertension will be evaluated as a predictor of efficacy of~     bevacizumab associated with chemotherapy, in terms of progression-free survival (Main~     endpoint).~      The duration of the study will be approximately 42 months.~   "
140096|NCT01733615|"~     The purpose of this study is to find out more about some of the unusual chemicals (called~     oligosaccharides) that can occur naturally as a result of processes in the body. Researchers~     want to look at how these chemicals change with time and how they change between different~     patients with MPSIVA. These unusual chemicals were recently discovered in the urine from~     patients with MPSIVA. The investigators would like to study these chemicals before a specific~     enzyme replacement therapy is used. If the investigators understand how these chemicals~     change, the investigators may be able to use them to monitor this condition in the near~     future as well as help doctors know whether certain therapies work well in their patients.~   "
140097|NCT01733602|"~     The primary aim for the study is to determine whether transcranial direct current stimulation~     (tDCS) enhances training gains on cognitive training (CT) tasks. Secondary aims are to~     determine whether tDCS combined with CT causes larger transferable improvements on~     non-trained tasks (i.e., generalisation effects) and whether these generalisation effects are~     maintained over time (i.e., maintenance effects).~      Specific hypotheses are:~        1. CT combined with active tDCS will produce greater training gains on CT tasks compared to~          a similar control group receiving CT with sham tDCS.~        2. CT combined with active tDCS will produce greater generalisation effects on non-trained~          cognitive tasks compared to CT with sham tDCS.~        3. The cognitive improvements gained by patients from both interventions will be maintained~          over 1 month follow-up.~   "
140098|NCT01733589|"~     Resistance of hypoxic tumor cells to radiation is a significant reason of failure in the~     local control of tumors, especially the squamous cell carcinomas. Preclinical models have~     shown that Endostar may transiently normalize the tumor vasculature to make it more~     efficient for oxygen delivery, thereby providing a window of opportunity for enhanced~     sensitivity to radiation treatment. This study is to evaluate the safety, toxicity, and~     efficacy of the addition of Endostar Continued Pumping into Vein to the standard CCRT regimen~     in patients with unresectable stage III NSCLC.~   "
140099|NCT01733576|"~     This project will use a new form of non-invasive brain stimulation called high-definition~     transcranial direct current stimulation (HD-tDCS) to facilitate verbal learning. This form of~     stimulation is similar to transcranial direct current stimulation (tDCS) but allows for more~     spatially focused stimulation. We hypothesise that HD-tDCS when applied to regions of the~     brain important for learning and memory will improve verbal learning and memory compared to~     sham HD-tDCS.~   "
140100|NCT01733563|"~     The objective of this study is to investigate the impact of sugar sweetened beverages on the~     fat metabolism of healthy young men. It is well known that consumption of beverages sweetened~     with fructose is associated with different health risks such as type 2 diabetes. The present~     study has been designed to dissect differences in the metabolic pathways of fructose and~     glucose, but also metabolic adaptations during fructose, glucose and sucrose diets. During a~     period of seven weeks subjects will consume either fructose, glucose or sucrose sweetened~     beverages or continue their usual drinking habits. During these seven weeks there will be~     different metabolic investigations using stable isotope tracers. First, the rate of lipolysis~     and beta-oxidation will be determined. Second, the rates of fatty acid synthesis will be~     measured. During all examinations there will also be substrate- and energy-utilization~     measurements by indirect calorimetry, blood analysis and morphometric measurements. Based on~     the literature main hypotheses are: Fructose enhances de novo lipogenesis postprandially and~     also in the fasting state significantly more than glucose by enhanced expression of lipogenic~     enzymes. Fructose decreases beta oxidation via downregulation of oxidative enzymes.~   "
140101|NCT01733550|"~     The purpose of this study is to compare glaucoma patients' own I Care measurements by the~     standard Goldmann applanation tonometer intraocular pressure (IOP) measurements.~   "
140102|NCT01733537|"~     The purpose of this study is to determine whether providing motorcycle taxi drivers with a~     free reflective fluorescent vest will result in increased use of reflective or fluorescent~     clothing compared to education about wearing reflective or fluorescent clothing alone.~   "
140108|NCT01733446|"~     The investigators data reveal an important new observation regarding the recovery of~     breathing during emergence from general anesthesia: respiration resumes as a prolonged~     abdominal expiration event.~      The present study aims to further clarify the physiology of recovery of breathing with the~     addition of a cutaneous monitor for arterial carbon dioxide measurement and a comparison of~     two different recovery paradigms.~   "
140109|NCT01733433|"~     The main goal of this study is to evaluate the effect of taping on postural control during~     dynamic exercises. 30 subjects with Chronic ankle instability (CAI) will be included in the~     study. Several questionnaires regarding anthropometric data, medical history, activity level~     and functional status will be filled in by the participants. Postural control will be~     measured using a force plate and an optoelectronic system to capture lower limb kinematics.~     Subjects will be asked to perform a forward hop, sideward hop and a vertical drop, and they~     have to maintain their balance for 10 seconds after landing. 5 good trials of each movement~     will be captured. Subjects with CAI will perform these exercises with and without tape.~     Hypothesis is that subjects with CAI that tape will enhance postural control.~   "
140110|NCT01733420|"~     A clinical trial to evaluate and compare three different products used for endodontic~     treatment (taking the infected nerve out of the teeth) of primary teeth.~      Null Hypothesis: The new biological products (WMTA and Biodentine) behave as good as the~     former iodoform product.~   "
140111|NCT01733407|"~     In hereditary sensory and autonomic neuropathy type 1 (HSAN1) the investigators recently~     discovered the accumulation of two neurotoxic sphingolipids. It appears that these lipids~     arise as the mutant enzyme has a reduced affinity for its normal preferred substrate~     L-serine. The investigators now plan to perform a two year study of L-serine supplementation~     to correct the biochemistry and neurological disease in humans with HSAN1. In the course the~     investigators will also establish correlations between an existing neurological rating scale~     of sensory neuropathy and intraepidermal nerve fiber density.~      Funding Source - FDA OOPD~   "
140112|NCT01733394|"~     The United States Food and Drug Administration (FDA) has specific rules which generic drug~     companies must follow to get a generic copy of a seizure medication approved. Currently, FDA~     approves generic drugs by requiring studies on normal volunteers who don't have epilepsy and~     who take just one dose of the generic drug followed by a series of blood tests. Some people~     with epilepsy and their physicians have complained about side effects or loss of seizure~     control when taking generic drugs, but no one knows if these complaints are truly because of~     problems with the generic drugs.~      This research is to determine whether several different generic versions and the brand~     version of the medication lamotrigine perform in a similar way when given to people with~     epilepsy.~      The study drug Lamictal® (lamotrigine) and both of the generic forms of lamotrigine to be~     tested are approved by the FDA for the treatment of seizures.~   "
140113|NCT01733381|"~     Aerobic exercise impacts bodily processes implicated in the pathophysiology of major~     depression. Consistent with these effects, aerobic exercise in general, and running in~     particular, has been repeatedly shown to have both immediate mood elevating and longer-term~     antidepressant effects. To the investigators' knowledge, all studies of running as a~     therapeutic intervention for mood have had subjects run in standard running shoes, despite~     increasing evidence that running barefoot or in shoes with minimal effect on foot strike~     (i.e. minimally shod) leads to marked changes in how people run in ways that might have~     physiological effects of relevance to health. Thus, nothing is currently known about~     differences in effects on depression-relevant physiological or emotional functioning between~     running either barefoot or minimally-shod vs. running in standard running shoes (hereafter~     called shoed). The current pilot study is designed to begin addressing these issues by~     examining effects of minimally shod vs. shoed running on non-invasive measures of autonomic~     nervous system (ANS) functioning and mood state.~   "
140114|NCT01733368|"~     Optimization and evolution of the patient will be evaluated over 6 months after the implant.~   "
140115|NCT01733355|"~     [F-18]T807 is being developed as a diagnostic radiopharmaceutical for PET imaging of the~     human brain.~   "
140116|NCT01733342|"~     To compare the performance of domestic chemoport and imported chemoport~   "
140117|NCT01733329|"~     Objective: to demonstrate that buccal misoprostol administration during cesarean delivery in~     women with risk factors for uterine atony decreases the need for additional uterotonic~     medications, uterine atony and postpartum hemorrhage.~      Design: randomized, double-blinded, placebo-controlled trial.~   "
140118|NCT01733316|"~     The purpose of this study is to gather information about the effectiveness (how well it works~     to treat cystinosis) and safety of a new form of cysteamine bitartrate called RP103, compared~     to the already-approved drug cystinosis patients are taking called Cystagon®.~      In cystinosis, the body builds up cystine. When taken regularly, the active ingredient of~     Cystagon® (cysteamine bitartrate) reduces cystine in the body. RP103 has the same active~     ingredient as Cystagon® and is designed to reduce cystine in a similar way that Cystagon®~     does. To decide if RP103 is better than Cystagon®, the study will look at two types of blood~     tests. One test is pharmacodynamics (PD), which measures the amount of white blood cell (WBC)~     cystine after taking study drug. WBC cystine is a laboratory test used to find out if~     cysteamine bitartrate is reducing cystine levels in the body. The second test is~     pharmacokinetics (PK), which measures the amount of cysteamine in the blood after taking the~     drug.~      RP103 is different from Cystagon®: Instead of the cysteamine bitartrate being absorbed from~     the stomach, RP103 is designed to be absorbed from the small intestine. This may make the~     effects of the drug last longer, so that it can be taken twice a day instead of four times a~     day like Cystagon®.~      Some cystinosis patients have bad breath (halitosis) when they take Cystagon®. Study~     participants who experience bad breath with Cystagon® will be asked if they would like to~     participate in an optional halitosis substudy to investigate this issue by collecting some~     extra PK blood samples.~   "
140158|NCT01732757|"~     This study will evaluate the efficacy of Lastacaft® (Alcaftadine 0.25%) and Pataday™~     (Olopatadine 0.2%) as compared to each other and to placebo in the prevention of ocular~     itching associated with allergic conjunctivitis.~   "
140180|NCT01732471|"~     This is an open-label, non-comparative, Phase 3 study to evaluate the degree, frequency of~     response and safety of Kuvan® (sapropterin dihydrochloride) in subjects aged 4 to 18 years~     who have phenylketonuria and with elevated blood phenylalanine level of greater than or equal~     to 450 micromole per liter.~   "
140119|NCT01733303|"~     Osteoporosis is a prevalent health concern among older adults and is associated with an~     increased risk of falls that can cause fracture, injury or mortality. Identifying the factors~     related to falls occurring within this population is essential for the development of~     effective regimes for fall prevention. Studies have shown that muscle quality and good~     posture alignments are critical for balance control in older adults. People are diagnosed~     with osteoporosis often combining with muscles weakness, and increased spine kyphosis leading~     vertebral, fractures and poor balance control, even falls. Therefore, improving muscle~     quality, strengthening weak muscles and correcting postural alignment are essential elements~     for fracture and fall prevention in older adults with osteoporosis. The long-term objectives~     of this work are to prevent fracture and fall in older adults with osteoporosis by improving~     the function of degenerative muscles using exercise training.~   "
140120|NCT01733290|"~     This study is designed and aimed at determine the clinical efficacy of BoNT-A on patients~     with dysfunctional voiding. The results of this study can provide further information for~     patient selection and therapeutic duration.~   "
140121|NCT01733277|"~     The primary objective of this study is to identify osteoarthritis (OA) structural changes, as~     assessed by MRI, that best correlate with the presence of neuropathic pain (NP) using the~     PainDETECT questionnaire (PainDETECT ≥ 13) on a population of patients with OA of the knee~     experiencing moderate to severe pain (VAS ≥ 40 mm).~   "
140122|NCT01733238|"~     This study is sponsored by Sierra Oncology, Inc. formerly ProNAi Therapeutics, Inc. It study~     is a multi-center, nonrandomized, open-label, pilot Phase II investigation of PNT2258 to~     characterize anti-tumor activity and collect safety data on patients with relapsed or~     refractory lymphoma.~   "
140123|NCT01733212|"~     SPECIFIC AIMS~        -  Assess risk factors for nausea and vomiting in c-section patients undergoing regional~          anesthesia~        -  Quantify the incidence of nausea and vomiting intraoperatively and postoperatively in~          the ginger and placebo groups.~        -  Quantify post-operative analgesia and pruritus in the ginger and placebo groups~        -  Quantify patient satisfaction of the ginger and placebo groups~        -  Assess patient expectation of ginger on post-op day three~   "
140124|NCT01733199|"~     This study is composed of a main study and an ancillary one. The objective of the main study~     is to define, on the psychopathological, neurological, pharmacokinetic and genetic plan, the~     predictive factors for developing a behavioural addiction (BA) secondarily to the~     dopaminergic treatment, associated or not to a dopamine dysregulation syndrome (DDS), in~     patients with Parkinson's disease.~      3 particular profiles of patients will be established:~        -  BA- : no secondary behavioural addiction~        -  BA+/DDS-: secondary behavioural addiction, without dopamine dysregulation syndrome~        -  BA+/DDS+: secondary behavioural addiction, with dopamine dysregulation syndrome~      We wish in particular:~        -  To differentiate, among the BA+ subjects, those for who is a DDS from those for who we~          can evoke a side effect of the dopaminergic treatment~        -  To demonstrate that the BA+/DDS- subjects present pharmacokinetic particularities~          causing the occurrence of the BA.~        -  To clarify the possible relationship between the dosage and the pharmacodynamics of the~          treatment (especially that of pramipexole) in one hand, and the developing of BA in the~          other hand.~        -  Demonstrate that the subjects BA + / DDS- are individually genetic vulnerability~          (related to the dopamine system), originally from the occurrence of the BA.~      This study has several levels of evaluation, we chose describe the methodology of the study~     in 3 axis : Psychopathology axis, Neurological axis and pharmacokinetic axis.~      The pharmacokinetic aspects will be studied only on a part of the sample, in an ancillary~     study centered on the pharmacokinetic of the pramipexole (in its immediate release form).~   "
140125|NCT01733186|"~     The purpose of this study is to determine whether CARTISTEM, a cell therapeutic product, is~     safe and effective in the treatment of articular cartilage defects of the knee as a result of~     ageing, trauma, or degenerative diseases.~   "
140126|NCT01733173|"~     The purpose of this study is to better understand why some children with cancer have~     difficulty speaking after brain surgery. Difficulty speaking may be due to known~     complications to the language centers in the brain. These language centers may be located in~     slightly different places in different people. This study will study which areas may be~     damaged.~   "
140127|NCT01733160|"~     This observational registry will characterize contemporary stroke prevention in Canadian~     adults with atrial fibrillation, and provide clarity in understanding physician preferences~     for the various oral anticoagulants available in the Canadian marketplace. This study will~     determine the patient profiles of those selected for the various therapies available in~     Canada and provide an understanding of the factors involved in drug selection and management.~   "
140128|NCT01733147|"~     Will oral supplementation with Omega 3 free fatty acids in obese Barrett's esophagus subjects~     downregulate pro-neoplastic and pro-inflammatory pathways in the esophagus to~     anti-inflammatory pathway?~   "
140129|NCT01733134|"~     Patients being hospitalized for acute heart failure and already receiving standard therapy~     will be randomized to receive either tolvaptan or placebo, based on the level of copeptin~     measured in their bloodstream. Patients with high copeptin levels will be able to participate~     in the trial, patients with low levels will be excluded. Patients being admitted to the~     observation unit for acute heart failure and already receiving standard therapy will be~     randomized to receive either tolvaptan or placebo without consideration of the copeptin~     level. The hypothesis is that patients receiving tolvaptan will have better improvement of~     shortness of breath than those receiving placebo, within 9 hours of drug administration.~   "
140130|NCT01733121|"~     The purpose of this study is to evaluate the efficacy, safety, and tolerability of NBI-98854~     (titrated to a subject's optimal dose in the range of 25 to 75 mg) administered once daily~     for the treatment of Tardive Dyskinesia (TD) symptoms.~   "
140131|NCT01733108|"~     The purpose of this study is to determine how multiple doses of canagliflozin (JNJ-28431754)~     affect the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how~     the drug affects the body) of a single dose of glyburide.~   "
140132|NCT01733095|"~     Portopulmonary hypertension denotes pulmonary hypertension complicating portal hypertension~     and is present in approximately 5% of cirrhotic patients. Treatment options include~     prostanoids, sildenafil, and the endothelin-receptor antagonists, bosentan and ambrisentan.~      This study investigates the safety and efficacy of ambrisentan in portopulmonary~     hypertension.~   "
140133|NCT01733082|"~     The Mycophenolate Pregnancy Registry is designed as a prospective, observational registry~     collecting data regarding mycophenolate exposure during pregnancy, and pregnancy outcomes,~     fetal and infant outcomes after exposure. Early and later term pregnancy outcomes will be~     solicited at selected gestational time points. Structural and functional birth defects~     identified in the perinatal period through one year of life will be collected and classified.~      This is a non-proprietary registry and is a component of a comprehensive pregnancy Risk~     Evaluation and Mitigation Strategy (REMS) plan required by the FDA for all~     mycophenolate-formulations, including CellCept, Myfortic and any generic formulations.~   "
140134|NCT01733069|"~     The objectives of this study are to establish the performance characteristics of the AC2~     (APTIMA Combo 2) Assay on the PANTHER System for the sample types cleared for use on the~     TIGRIS and DTS (Direct Tube Sampling) Systems and to demonstrate the repeatability and~     reproducibility of the AC2 Assay on the PANTHER System.~   "
140135|NCT01733056|"~     Biomedical Lay Summary Title: Characterization of immune response to vaccination in patients~     receiving single-drug immunosuppressive therapy Principal Investigator: Robert Swerlick, MD~     Other Investigators: Rafi Ahmed, PhD Suephy Chen, MD Jens Wrammert, PhD Adam Sperduto~        1. Problem of Interest We are proposing to study the effectiveness of vaccines in people~          who are taking drugs that affect the immune system. There are many populations of people~          who have chronic medical conditions that require them to have long-term treatment with~          immunosuppressive medications (drugs that decrease the function of the immune system).~          Examples of these patients include organ transplant recipients, patients with immune~          cell cancers such as leukemia and lymphoma, patients with inflammatory disorders such as~          lupus or scleroderma, and patients with skin conditions requiring steroid-based creams,~          ointments, pills, or injections. Patients who are taking these medications should~          receive appropriate vaccinations such as tetanus boosters, influenza vaccines, and~          pneumonia vaccines. The effectiveness of vaccinations depends in large part on a strong~          response to the vaccine by the immune system. Drugs that decrease immune system function~          therefore, may also decrease the effectiveness of vaccines.~        2. How the Problem of Interest will be studied~      We plan to give three different groups of participants influenza vaccinations and measure~     each participant's immune system response through blood tests. The three groups will be:~        1. Healthy people taking no immunosuppressive medications~        2. Patients with skin conditions requiring treatment with azathioprine and currently taking~          no other immunosuppressive agents~        3. Patients with psoriasis requiring treatment with TNF-alpha (tumor necrosis factor-alpha)~          and currently taking no other immunosuppressive medications.~      All participants will be between 18 - 89 years old and will not have had influenza~     vaccination within the previous six months. We will administer the vaccination on day 0. We~     will take blood samples on days 0, 7, and 28 following vaccination. We will use these blood~     samples to measure the amount of antibodies produced to the vaccine and the response of~     specific immune system cells known as B-lymphocytes. Using statistical methods, we will~     compare these findings between the three groups of participants to determine if differences~     in response to the vaccination exist.~      3. How the research will advance scientific knowledge and/or human health To our knowledge~     there is no scientific data available regarding the effectiveness of vaccinations in patients~     receiving only one specific immunosuppressive medication. We will also be using new~     techniques developed at Emory to measure the B-lymphocyte response to the vaccine. This~     research could potentially help guide vaccination strategies for people requiring~     immunosuppressive medications and prevent infectious disease in these populations as well as~     the general population.~   "
140136|NCT01733043|"~     The objective of this study is to determine the effect of dexmedetomidine infusion on the~     Apnea / Hypopnea Index (AHI) of individuals with previously documented obstructive sleep~     apnea. We hypothesize that dexmedetomidine infusion may reduce the AHI in patients with~     obstructive sleep apnea (OSA).~   "
140137|NCT01733030|"~     PROJECT SUMMARY:~      PTSD is a debilitating psychiatric condition precipitated by exposure to extreme, or life~     threatening, trauma with an estimated lifetime prevalence between 8% and 9% in U.S. adults.~     One core symptom of PTSD is intense psychological distress in the presence of stimuli that~     resemble one or more aspects of the trauma experience (DSM-IV). This phenomenon referred to~     as stimulus generalization has received surprisingly little empirical testing in the context~     of clinical anxiety in general, and PTSD more specifically. The current proposal represents~     the first effort to study the neurobiology and pharmacology of this PTSD-relevant learning~     phenomenon across those with and without PTSD. The objective of this particular proposal is~     to apply fMRI and pharmacologic methods to: 1) identify brain mechanisms associated with~     generalization of conditioned fear and 2) examine the pharmacologic modifiability of levels~     of generalization using a partial agonist at the NMDA receptor complex (D-cycloserine) shown~     to increase discrimination of CS+ (danger cue) and CS- (safety cue) in animal studies.~   "
140138|NCT01733017|"~     The purpose of is to test the effects of a 6-month nutrition intervention of dietary sodium~     reduction combined with supplementation of lycopene and omega-3 fatty acids on heart failure~     symptoms, health-related quality of life, and time to heart failure rehospitalization or~     all-cause death.~   "
140139|NCT01733004|"~     This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a 3+3~     design, evaluating MM-141 at varying dose levels and frequencies.~   "
140140|NCT01732991|"~     The PVP by Greenlight laser 180W is becoming a potential therapeutic alternative in the~     treatment of benign prostatic hypertrophy (BPH) as recommended.~      The PVP creates a prostatic box after the vaporization of the prostatic tissue of BPH. The~     underlying prostatic tissue is the site of an ischemic necrosis secondary to the thermal~     effects of proximity of the PVP. We intend to measure by prostatic MRI and contrast-enhanced~     ultrasound the necrosis.~   "
140141|NCT01732978|"~     The crying baby is a sound signal including information relating to this individual identity~     or related to its physiological or motivational state.~      The objective of the study is to determine the implementation of the recognition of~     individual tone of the baby by his parents and acoustic modulation of the baby based on~     parental response.~      The detailed study of the acoustic structure of crying and analysis of parental perception~     will determine the dynamics during the first weeks of life of this recognition, and the~     influence of factors such as parental presence, or breastfeeding .~      For this study is organized in three stages: first, the recording of the baby's crying~     Secondly, a listening test parental soundtracks and third analysis of the acoustic structure~     of crying and parental response.~   "
140142|NCT01732965|"~     To evaluate if the combination of psoralen plus ultraviolet A and narrowband ultraviolet B is~     more effective than narrowband ultraviolet B alone in the treatment of vitiligo.~   "
140170|NCT01732601|"~     This study will identify the effectiveness of an intensive treatment program for teens who~     are at high risk for harming themselves.~   "
140171|NCT01732588|"~     The purpose of this study is to determine the bioavailability of nanoparticulate OZ439~     delivered to the proximal small bowel (PSB) via the Enterion™ capsule relative to oral OZ439~     suspension (current powder in bottle [PIB]) and oral nanoparticulate OZ439.~      The study will also characterise the plasma concentration time profile of OZ439 when~     delivered via Enterion capsule to the PSB in comparison with OZ439 PIB formulation delivered~     orally and nanoparticulate OZ439 delivered orally Safety and tolerability of OZ439~     formulations will be determined following delivery to the PSB and administered orally~   "
140143|NCT01732952|"~     This cross-sectional, non-interventional, and observational study will assess the lipid~     profile of patients who have been taking lipid-modifying drugs (i.e., proportion of patients~     achieving treatment to goal according to national and international lipid management~     guidelines) during a single visit to their physicians on an outpatient basis in 6~     representative geo-economic regions in China: Northeast, North, East, South, Southwest, and~     Northwest; and within each region, in three tiers of hospitals: tier 3 (primary or teaching~     hospitals), tier 2 (secondary or city level hospitals), and tier 1 (community~     hospitals/health centers). The investigators will primarily be cardiologists,~     endocrinologists, neurologists, gerontologists, internists, or other physicians who are~     representative of the general population of physicians managing patients with dyslipidemia~     and/or at high risk for cardiovascular events likely to be treated with lipid-modifying~     drugs. Demographic data, cardiovascular risk factors, a history of cardiovascular disease and~     cardiovascular treatments will be documented in a single visit through patient clinical~     examination and chart review.~      DYSIS-China is part of a string of epidemiological studies that share the same master~     protocol, which has been conducted in different countries mainly in Europe and Canada. The~     analysis of the pooled studies including overall data and cross-country comparisons is the~     subject of a distinct protocol.~   "
140144|NCT01732939|"~     The study purpose is to observe which neoadjuvant chemotherapy regimens is the better for~     invasive breast cancer. The neoadjuvant chemotherapy regimen is sustained anthracyclines plus~     taxanes or from anthracyclines plus taxanes to vinorelbine plus cisplatinum.~   "
140145|NCT01732926|"~     The primary objective of this study is to evaluate the addition of idelalisib to~     bendamustine/rituximab on progression-free survival (PFS) in adults with previously treated~     indolent non-Hodgkin lymphoma (iNHL).~      An increased rate of deaths and serious adverse events (SAEs) among participants with~     front-line chronic lymphocytic leukemia (CLL) and early-line iNHL treated with idelalisib in~     combination with standard therapies was observed by the independent data monitoring committee~     (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data~     and terminated this study in agreement with the DMC recommendation and in consultation with~     the US Food and Drug Administration (FDA).~   "
140146|NCT01732913|"~     The primary objective of this study is to evaluate the effect of the addition of idelalisib~     to rituximab on progression-free survival (PFS) in adults with previously treated indolent~     non-Hodgkin lymphoma (iNHL).~      An increased rate of deaths and serious adverse events (SAEs) among participants with~     front-line chronic lymphocytic leukemia (CLL) and early-line iNHL treated with idelalisib in~     combination with standard therapies was observed by the independent data monitoring committee~     (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data~     and terminated this study in agreement with the DMC recommendation and in consultation with~     the US Food and Drug Administration (FDA).~   "
140147|NCT01732900|"~     The purpose of this study is to determine the performance of a genetic assay, GemART, in~     cumulus cells predictive of embryo viability, and pregnancy success in women undergoing in~     vitro fertilization (IVF). Performance is defined as success rate per embryo transferred, as~     measured by the implantation rate of embryos transferred.~   "
140148|NCT01732887|"~     In this study we are testing computer-based brain fitness exercises. The games are designed~     to improve people's cognitive abilities brain functions, like memory, concentration, and~     ability to do two things at once. We are testing whether this cognitive training brain~     exercises will improve understanding of spoken sentences speech comprehension in people who~     use cochlear implant and/or hearing aids. We predict that cognitive training will improve~     speech comprehension in cochlear implant and/or hearing aid users.~   "
140149|NCT01732874|"~     The purpose of this research study is to find out whether preterm infants are receiving~     enough of the essential and long chain fatty acids important for brain development and immune~     function. Our current intravenous (IV) fats do not contain the long chain fatty acids and~     different milk sources have different compositions. We would like to evaluate lactating~     mothers dietary intake and breastmilk level of fatty acid status by doing an analysis of~     their blood and breastmilk samples after they have been supplemented with a currently used~     fatty acid supplement (DHA- Martek Biosciences, now known as Dutch State Mines (DSM)~     Nutritional Lipid) The DHA supplement is available over the counter.~      The information learned from this research study may benefit other mothers and babies in the~     future. The information could help make sure premature babies are receiving the right~     nutrients they need for appropriate growth and development.~   "
140150|NCT01732861|"~     This is a dose finding study using a 3 + 3 dose escalation and expansion design to determine~     a Not Tolerated Dose (NTD), Optimal Biological Effect Dose (OBE) and / or Maximum Tolerated~     Dose (MTD). These data will be used to establish a Recommended Phase 2 Dose (RP2D) for the~     combination of CC-292 and lenalidomide in subjects with Chronic Lymphocytic Leukemia (CLL).~   "
140151|NCT01732848|"~     The purpose of this study is to determine the rate of kidney or heart impairment, if any, in~     subjects who received BMS-986094 (INX-08189) in Phase 1 clinical trials~   "
140152|NCT01732835|"~     This investigation is a prospective, non-randomized, multi-center trial to evaluate the~     extended safety and performance of the HAART model 300 annuloplasty ring when used to~     surgically repair the aortic valve using a 3-D intra-annular mounting frame.~   "
140153|NCT01732822|"~     The purpose of this study is to compare the effects of ticagrelor and clopidogrel in patients~     with Peripheral Artery Disease.~   "
140154|NCT01732809|"~     The purpose of this study is to assess the fields of effect (FE) of ABO and ONA at the same~     labeled unit dose (1:1 units), comparing both sweat gland and muscle activity.~   "
140155|NCT01732796|"~     The aim of the study is to confirm efficacy of treatment for 16 and 24 weeks in chronically~     infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.~   "
140156|NCT01732783|"~     This is a multicenter, observational prospective cohort study in France and Germany.~     Treatment centres with a focus on treating subjects with mCRC will be prospectively defined~     for potential inclusion in the study. Eligible subjects will be enrolled and have~     retrospective data collected from Baseline up to the point of enrolment. All subsequent~     chemotherapy cycles and Vectibix® doses will be recorded prospectively. Each subject will~     have data collected until approximately 30 days after the end of Vectibix® treatment, death,~     withdrawal of consent, loss to follow-up or up to 12 months from the first dose of Vectibix®,~     whichever occurs first.~   "
140159|NCT01732744|"~     To evaluate the efficacy of a castor bean-based solution (Ricinus communis) for removal of~     complete denture biofilm, comparing it with two products available on the market (sodium~     hypochlorite and alkaline peroxide). Fifty complete maxillary denture-wearers were instructed~     to brush their dentures after meals and once a day, for a period of 07 days, immerse them in~     the following solutions: A - Control: Physiological solution(20 minutes). B - Polident~     alkaline peroxide(3 minutes). C - 1% sodium hypochlorite(20 minutes). D - castor bean-based~     solution(20 minutes). The participants immersed their dentures in each of the solutions,~     according to a randomized sequence. For biofilm quantification, before (Baseline) and after~     the use of each product, the internal surfaces of maxillary complete dentures were revealed~     (1% neutral red), photographed and the stained biofilm was quantified with the aid of~     software (Image Tool 3.0). After concluding measurements of the areas (total and biofilm),~     the percentage of surface covered by biofilm of the complete denture was calculated .~   "
140160|NCT01732731|"~     The purpose of this project is to examine if early exposure to intensive, short-term~     locomotor treadmill training (LT) in young children with neuromotor impairment will help~     develop walking skills earlier, decrease the amount of outside assistance needed (such as a~     walker or crutches) as compared to children with neuromotor impairment who receive~     traditional physical therapy intervention.~   "
140161|NCT01732718|"~     The purpose of this research study is to learn about the effect of the drug, atorvastatin, on~     blood vessels in patients with sickle cell disease.~      The primary hypothesis is that endothelial dysfunction is an important contributor to the~     pathophysiology of albuminuria in SCD. The investigators propose that atorvastatin will~     improve endothelial dysfunction, decrease levels of sFLT-1, and decrease albuminuria in SCD~     patients.~      Participants will be individuals with sickle cell disease, age 18 to 60, who have some degree~     of albuminuria. A total of 19 subjects, males and females, will be enrolled. The study is~     made up of Screening, Treatment, and Follow Up phases and has a cross-over design. After~     patients are screened for eligibility, they will be randomized to receive atorvastatin or~     placebo in the initial six-week treatment period. When that is complete, there will be a~     four-week washout period before they begin another six-week treatment period. In the second~     treatment period, they cross-over to the other treatment arm. Four weeks after the end of~     the second treatment period, follow-up safety assessments will be done.~   "
140162|NCT01732705|"~     The purpose of this study is to determine the effect of High Intensity Interval Training~     (HIT) on insulin sensitivity in skeletal muscle in patients with type 2 diabetes.~   "
140163|NCT01732692|"~     To compare colon cleansing quality induced by the 2 different modes of MOVIPREP® intake in 5~     colon segments prior to colonoscopy.~   "
140164|NCT01732679|"~     A descriptive study of the stroke rehabilitation content in specialized clinics in seven~     countries: procedures for admission to rehabilitation, services available and provided to~     patients, as well as duration of the stay and discharge routines. An observational study of~     changes in regard to the physical function, quality of life and psycho-social factors in~     stroke patients before and after specialized rehabilitation~   "
140165|NCT01732666|"~     Opioids has been reported to cause hyperalgesia. Opioid induced hyperalgesia (OIH) is defined~     as paradoxically lowering the threshold of pain after the exposure of opioid. Remifentanil is~     a short acting opioid that is commonly used during anesthesia and surgery. However, OIH was~     reported to occur after surgery when large amount of remifentanil was administered. On the~     other hand, nefopam is a centrally acting, non-opioid analgesic. Nefopam has been reported to~     have analgesic and anti-hyperalgesic effect.~      The investigators hypothesized that nefopam administration could prevent OIH or reduce the~     severity of OIH. Therefore, the objective of the study is to find out the effect of nefopam~     on remifentanil induced hyperalgesia in patients undergoing laparoscopic abdominal surgery.~   "
140166|NCT01732653|"~     The proposed randomized controlled trial will evaluate the effects of treadmill training~     augmented with virtual reality on fall risk.~      300 older adults with a history of falls will be recruited to participate in this study. This~     will include older adults (n=100), patients with mild cognitive impairment (MCI) (n=100), and~     patients with Parkinson's disease (PD)(n=100). Subjects will be randomly assigned to the~     intervention group (treadmill training with virtual reality) or to the active-control group~     (treadmill training without virtual reality). Each person will participate in a training~     program set in an outpatient setting 3 times per week for 6 weeks. Assessments will take~     place before, after, and 1 month and 6 months after the completion of the training.~   "
140167|NCT01732640|"~     Trial Objectives:~      The objective is to investigate the efficacy and safety of afatinib with induction~     chemotherapy in primary unresected patients with locally advanced, HPV-negative, stage III or~     IVa/b HNSCC including oral cavity, oropharynx, hypopharynx, or larynx.~      Primary Objective Phase I The primary objective of the phase I portion of the trial is to~     determine the maximum tolerated dose (MTD) or the recommended phase II dose of daily oral~     afatinib that is safe in combination with carboplatin AUC 6 and paclitaxel 175mg/m2 q 21 days~     as an induction regimen.~      Primary Objective Phase 2 The primary objective of the phase 2 portion of the trial is to~     estimate the objective tumor response rate and toxicity with induction therapy in patients~     treated on the afatinib dose determined in Phase I.~      Secondary Objectives The secondary objective of phase II is to estimate: 1) the overall~     response to entire treatment after completion of CRT, 2) progression-free survival (PFS) rate~     at 2 years, and 3) overall survival (OS) at 2 years.~   "
140168|NCT01732627|"~     Primary objectives:~        -  To describe the antibody responses to meningococcal serogroups A, C, Y, and W-135,~          measured by serum bactericidal assay using human complement (hSBA) and baby rabbit~          complement (SBA-BR), induced by a single dose of MenACYW conjugate vaccine or Menomune®~          - A/C/Y/W-135.~        -  To describe the safety profile of a single dose of MenACYW conjugate vaccine or~          Menomune® - A/C/Y/W-135.~   "
140169|NCT01732614|"~     This trial seeks to prove that sub-lethal laser power levels are as effective and less~     damaging than traditional laser. Diabetic macular edema (DME) affects approximately 29% of~     diabetic patients with a disease duration of 20 or more years and is one of the most frequent~     causes of vision loss in this population. The Early Treatment Diabetic Retinopathy Study~     (ETDRS) demonstrated a significant benefit of laser photocoagulation for the treatment of~     clinically significant macular edema, reducing the incidence of vision loss by approximately~     50% at 3 years' follow-up.~   "
140172|NCT01732575|"~     This RCT study addresses the topic of improving the possibilities for people with severe~     mental illness (SMI) to be engaged in meaningful daily occupations at community-based~     activity (CBA) centers. Meaningful occupation, which includes not only work-related~     activities, but also leisure, household and social activities, is assumed to generate health~     and wellbeing. It is well established that there is a relationship between satisfaction with~     daily occupations and well-being.~      A Swedish mental health care reform stated that the social services should provide meaningful~     daily occupations to people with SMI. However, evaluations of the effects of the reform~     conclude that the target group's needs for meaningful daily occupation have not been met.~      Thus, on the basis of governmental reports and evaluations, there is an urgent need for~     improving the quality of the activities and support offered at CBA centers. Therefore, the~     overarching aim of this project is to develop and implement an intervention method for~     improving the activities offered and support given at CBA centers, and evaluate the outcomes~     of that intervention.~      Specific aims~        -  Developing and implementing an intervention that means reorganization of CBA centers in~          such a way that they become enriched with characteristics that have been identified as~          rewarding and meaningful in previous research.~        -  Evaluating the outcome of that intervention on:~             -  the unit level, i.e., in terms of changes in the characteristics of the CBA~               centers,~             -  the individual level, in terms of changes among the consumers regarding~               satisfaction with the activities at the CBA center, perceived control, social~               interaction, quality of life, etc.~      Cluster randomization is used. Day centers are randomized to either giving the new~     intervention (enrichment) or continuing with care as usual during the study period, which~     is 14 months. This means that all participants in a day center get the type care their~     specific day center offers during the study period.~   "
140173|NCT01732562|"~     Patients from the Joint Replacement Institute scheduled to undergo primary total knee~     replacement surgery (TKR) will be invited to participate at the Pre Admission Clinic (PAC),~     University Hospital, London Health Sciences Centre. Baseline questionnaires of preoperative~     measures and demographic information and a cost analysis will be explored at the PAC for each~     patient. Patients will be randomized with the treatment group receiving access to a~     web-based, e-learning intervention. Postoperatively all patients will be asked to complete~     questionnaires at 6 weeks, 3 months and 1 year after their TKR surgery.~      Objectives~      The first primary objective is to compare the effect of two methods of providing patient~     education on expectations of surgical outcome in total knee replacement (TKR) patients.~      The second objective is to compare the effect of two methods of providing patient education~     on satisfaction with surgical outcome in TKR patients.~      The intervention of interest is an e-learning education program that spans both the~     preoperative and postoperative time period. The control condition will be the current method~     of patient education provided at the hospital study site.~      Hypothesis: Objective One~      More change in patient expectations will occur between preoperative and one year~     postoperative in the e-learning educational intervention group.~      Hypothesis: Objective Two~      More change in patient satisfaction will occur between preoperative and one year~     postoperative in the e-learning educational intervention group.~   "
140174|NCT01732549|"~     The purpose of this study is to confirm that tasquinimod used as maintenance therapy is~     active and tolerable in patients with metastatic castrate-resistant prostate cancer not~     progressing after a first chemotherapy with docetaxel.~   "
140175|NCT01732536|"~     The purpose of the study is to determine whether a steroid-eluting sinus implant is effective~     in improving chronic sinusitis symptoms in patients who experience recurrent blockage of the~     sinuses by polyps sometime after sinus surgery.~   "
140176|NCT01732523|"~     Atherosclerosis is a chronic, systemic and progressive disease affecting different arterial~     blood vessels in the body. Atherosclerotic lesions silently progress from small plaques to~     severe stenosis and may remain asymptomatic for years. Unstable plaques and stenosis (also~     called vulnerable plaques), however, are prone to rupture leading to myocardial infarction,~     or stroke. The proliferation of the small arteries that are distributed to the outer and~     middle coats of the larger blood vessels (vasa vasorum) and within the atherosclerotic~     plaques (neovascularization) are inherently linked with the atherosclerotic plaque~     development, plaque inflammation and vulnerability. By injecting ultrasound contrast agents~     (microbubbles) into the blood stream, it is possible to detect this microcirculation of the~     vessel wall and the neovascularization within the atherosclerotic plaque using a~     contrast-enhanced ultrasound (CEUS) imaging technique. Particularly, CEUS of the carotid~     artery has been introduced as a non-invasive technique to improve detection of carotid~     atherosclerosis and to evaluate the presence of carotid plaque neovascularization which has~     emerged as a new marker for plaque vulnerability. The project investigates the predictive~     value of the detection of carotid plaque neovascularization on CEUS imaging in patients with~     asymptomatic carotid artery stenosis regarding the progression of the carotid atherosclerotic~     lesion and future vascular events including myocardial infarction, stroke or vascular~     intervention. The investigators hypothesize that neovascularization within the carotid lesion~     will significantly be more pronounced in patients with progressive carotid lesions and in~     patients suffering future vascular events during. The project will support the concept that~     intraplaque neovascularization is associated with plaque instability and vulnerability and~     therefore, the use of CEUS may provide an additional non-invasive, simple, safe, and reliable~     imaging modality to risk stratify individuals. The identification of vulnerable that are at~     increased risk of rupture by identification of intraplaque neovascularization is expected to~     improve the prediction of future vascular events and thus allow for better treatment~     selection. It will help the clinician to further risk stratify carotid stenosis.~     Particularly, it will help to identify unstable carotid stenosis that may already benefit~     from invasive therapy as carotid thromboendarterectomy and stenting.~   "
140177|NCT01732510|"~     This is a 3-part study to assess the safety, tolerability, efficacy, pharmacokinetics (PK),~     pharmacodynamics (PD), and immunogenicity of MK-8226 in participants with moderate to severe~     atopic dermatitis. Part 1 (multiple rising dose study) objectives were to find the maximum~     tolerated dose (MTD) of MK-8226 and to assess safety and PK. Part 2 objectives were to~     determine safety, PK, and preliminary efficacy. Part 3 objectives were to further define~     safety and PK, and explore MK-8226 PK/PD to model the optimal dose range for future studies.~     The study was terminated early due to business reasons on 08 May 2014; final results from an~     analysis for Part 1 (efficacy, PK, safety, immunogenicity) and Part 2 (safety,~     immunogenicity) are summarized.~   "
140178|NCT01732497|"~     The purpose of this study is to evaluate hair reduction in the underarms in patients treated~     with the miraDry System.~   "
140179|NCT01732484|"~     Age-related cataract is the main cause of impaired vision in the elderly population~     worldwide. In the UK, more than half of people who are over 65 have some cataract development~     in one or both eyes. The only treatment that can restore functional visual ability is~     cataract surgery where the opacified crystalline lens is removed by phacoemulsification and~     an artificial intraocular lens is implanted. It is estimated that around 10 million cataract~     operations are performed around the world each year. Cataract operations are generally very~     successful, with a low risk of serious complications. The most common risk is developing a~     condition called posterior capsule opacification (PCO), which causes impaired vision to~     return.~      During the past two decades, cataract surgery underwent tremendous change and modernisation~     resulting in today's small incision phacoemulsification surgery and a safe technique with a~     short rehabilitation time for the patient. The most frequent long-term complication of~     cataract surgery remains to be posterior capsule opacification (PCO). In the past few years,~     refinements in surgical technique and modifications in IOL design and material have led to a~     decrease in the incidence of PCO.~      It has been shown that a sharp posterior optic edge inhibits migration of lens epithelial~     cells (LEC) behind the IOL optic and therefore have a lower incidence of posterior capsule~     opacification (PCO). Most IOL designs have open-loop haptics that are connected to the optic~     towards the end of the production process, also called multipiece designs.~      For several reasons such as better ease of use with injector systems and higher efficiency in~     the production process, companies have developed IOLs with open-loop haptics out of one block~     of material, also called single-piece designs. In the case of such single-piece IOLs, the~     haptics tend to be much thicker than with multipiece IOLs. A potential drawback of the thick~     haptics maybe an incomplete closure of the capsule at the optic rim with a reduced bending~     effect of the posterior capsule around the posterior optic edge. Additionally, the posterior~     sharp edge is often discontinuous in the region of the haptic-optic junctions. These~     locations may serve as a scaffold for LECs to migrate behind the IOL optic resulting in PCO.~     Nowadays a multitude of different single piece IOLS are available, many of them similar but~     of course with some differences in regard to the chemical composition of the acrylic material~     and the IOL design.~      The purpose of this study is to compare the intensity of posterior capsule opacification~     (PCO) between two different 1-piece foldable hydrophobic acrylic intraocular lenses (IOLs)~     over a period of 3 years.~   "
140181|NCT01732458|"~     The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability~     of aprepitant for the prevention of post-operative nausea and vomiting (PONV) in pediatric~     participants.~      Post-operative aprepitant plasma concentrations will be evaluated with a non-compartmental~     analysis (NCA) at each dose and for each age cohort. Full PK profiles analyzed using~     population PK modeling and simulation will be described in a separate report.~   "
140182|NCT01732445|"~     This phase II pilot trial studies how well ruxolitinib phosphate and danazol work in treating~     anemia in patients with myelofibrosis. Ruxolitinib phosphate and danazol may cause the body~     to make more red blood cells. They are used to treat anemia in patients with myelofibrosis.~   "
140183|NCT01732432|"~     The purpose of this study is to determine whether a relationship exists between a previously~     established diagnosis of endometriosis and the consecutive risk of developing a clear cell or~     endometrioid ovarian carcinoma. All histopathological records since 1980 with these diagnoses~     (endometriosis, clear cell and endometrioid ovarian carcinoma) will be reviewed. Cancer~     registry data will be assessed to investigate differences in survival of women with~     endometriosis-associated ovarian carcinomas and those ovarian carcinoma patients without~     previous diagnosis of endometriosis.~   "
140184|NCT01732419|"~     Physical exercise training appears effective for low to moderate patients assigned to cardiac~     rehabilitation. However, adherence to cardiac rehabilitation is low and physical activity~     levels often drop after attending the last supervised rehabilitation session.~      This study will compare home based physical exercise training including telemonitoring with~     regular centre based physical exercise training. Main outcome measures are the change in~     physical activity and the change in physical fitness (peak Oxygen uptake) after the initial~     rehabilitation period (12 weeks) and after 1 year. Secondary outcome measures are~     cost-effectiveness, training adherence, health-related quality of life and patient~     satisfaction.~   "
140185|NCT01732406|"~     The investigators hypothesize that treatment of acromegaly will be associated with an~     improvement in quality of life compared to active acromegaly. At the same time, they will~     also be studying the effects of different acromegaly treatments on the quality of life.~   "
140186|NCT01732393|"~     The study aims to evaluate the effect of Quercetin (a natural flavonoid) on prevention of and~     treatment of chemotherapy-induced oral mucositis in patients with blood malignancies.~   "
140187|NCT01732380|"~     The aim of this study was to compare raltitrexed/oxaliplatin plus radiotherapy versus~     radiotherapy in subjects with inoperable esophageal cancer.~   "
140188|NCT01732367|"~     This study will provide a rationale for switch from lamivudine plus adefovir to tenofovir~     monotherapy in Lamivudine plus Adefovir Treated Lamivudine-resistant chronic hepatitis B~     patients with Undetectable Hepatitis B Virus DNA~   "
140189|NCT01732354|"~     The investigators aim to clarify the issue of adequate duration of consolidation period of~     Chronic hepatitis B infection with antiviral treatment with Tenofovir which could strike a~     balance between durable HBeAg seroconversion and avoiding long-term inevitable serological or~     virological recurrence.~   "
140190|NCT01732341|"~     This study will test compare the Stentys Stent with the Multi-Link Vision™ stent system~     (Abbott Vascular Inc.)in patients with a heart attack. It is expected that the Stentys stent~     is not worse than the Vision stent.~   "
140191|NCT01732328|"~     Pregnancy and lactation are periods of high calcium requirement. Inadequate maternal calcium~     intake and vitamin D insufficiency may adversely affect fetal and neonatal growth and~     maternal bone mass particularly in adolescent mothers. The investigators propose to evaluate~     the influence of calcium plus vitamin D supplementation during pregnancy on bone mass of~     lactating adolescent mothers with habitually low calcium and vitamin D, on fetal growth and~     neonate bone mass. Mothers are randomly assigned to receive daily calcium (600 mg) plus~     vitamin D3 (200 IU) supplement or placebo from mid gestation until parturition. Fetal growth~     parameters are assessed by standard ultrasound techniques at mid and late gestation. Maternal~     bone mass is assessed by dual energy x-ray absorptiometry (DXA) at 2 and 5 months postpartum~     and 6 months after weaning. Infant bone mass is assessed by DXA at 2 months postpartum.~   "
140192|NCT01732315|"~     This protocol describes a study about vaccination uptake among adolescents. The purpose of~     the study is to determine whether parents who receive email reminders will be more likely to~     obtain Tdap (tetanus-diphtheria-acellular pertussis), HPV (human papilloma virus),~     meningococcal, and influenza vaccines for their adolescent children than parents who do not~     receive email reminders.~   "
140193|NCT01732302|"~     The purpose of this study is to determine whether an educational intervention given towards~     health care providers working in primary health care centers can reduce inappropriate~     prescribing in the elderly patient and thus reduce number and length of drug-related~     hospitalizations as well as number of emergency department visits in this patient group.~   "
140194|NCT01732289|"~     Age-related hearing loss, or presbyacusis, is one of the most common chronically handicapped~     conditions for the elderly. Many factors including genetics, diet, diseases, drugs,~     socioeconomic factors and environmental variables were considered to be related to the~     development of presbyacusis. Evidences have shown that genetic factors play an important role~     on presbyacusis. However, which genes or their genotypes are associated with presbycusis~     remain unknown.~      The aim of this project was to evaluate the association between the genotype of candidate~     genes and presbyacusis by cross-section and case-control study. In the first stage, the~     investigators plan to select 700 healthy subjects older than 50 with symmetric, sensorineural~     hearing loss. The subjects will receive basic otologic examination, pure tone audiometry,~     questionnaire, and genotype analysis. Because gender and age would affect hearing loss~     significantly, The investigators will convert the hearing level of all subjects into a gender~     and age independent Z-score according to ISO 7029 standard. And, The investigators define~     subjects within higher 30 % of Z-score as the presbyacusis group, and subjects within lower~     30% of Z-score as the control group. Finally, The investigators perform Chi square analysis~     to test the association between genotype of candidate genes or their combinations in both~     groups, and calculate the odds ratio for presbyacusis between different genotype of candidate~     genes. Further more, we will evaluate the effect of genotype of candidate genes, environment~     factors, and gene-environmental interaction on the severity of presbyacusis by multivariate~     logistic regression.~      In the second stage, The investigators wish to know the pattern of genotype and hearing level~     in the high risk families, according to results from the first stage, by description and~     case-control study. The investigators will perform t-test to evaluate the difference of~     Z-score in both groups. Besides, The investigators try to evaluate the effects of genotypes,~     environment factors, and gene-environmental interaction on hearing level in high risk~     families by multivariate logistic regression.~   "
140211|NCT01732068|"~     The purpose of the present study is to examine the level of ovarian response and the~     pregnancy rates among poor ovarian responders treated with a novel treatment protocol with~     150μg corifollitropin alfa followed by 300IU hMG in a short GnRH agonist protocol.~   "
141866|NCT01710358|"~     The purpose of this study is to determine whether baricitinib is superior to placebo in the~     treatment of participants with moderately to severely active Rheumatoid Arthritis (RA) who~     have had an inadequate response to methotrexate (MTX) treatment.~   "
140195|NCT01732276|"~     Breast cancer is a heterogeneous disease and can be classified into several distinctive~     subgroups. Triple-negative breast cancer(TNBC) is defined by lack of estrogen(ER),~     progesterone(PR) immunoreactivity and lack of human epidermal receptor-2(HER2)~     overexpression. TNBC comprises around 15% of all breast cancer and is characterized by its~     aggressive clinical behavior and insensitivity toward available targeted treatment strategies~     such as endocrine and anti-HER2 therapies.Although TNBC is sensitive to chemotherapy,early~     relapse with metastatic disease is common and the prognosis is poor. Development Of novel~     treatment strategies is,therefore,needed and the study of other potential targets in~     TNBC,like tyrosine kinase receptors,is a topic of interest.~      Epidermal Growth Factor Receptor(EGFR) is a transmembrane receptor tyrosine kinase that~     encoded by cell erythroblastosis virus oncogene B1(C-erbB1) and belongs to the~     HER/Erythroblastosis virus oncogene B(ErbB) family. By several signal pathways,EGFR regulates~     cell proliferation, differentiation, apoptosis, invasion,and angiogenesis,and serves as a~     poor prognostic factor.EGFR is overexpressed in a variety of malignancies including TNBC.Gene~     expression profiling and immunohistochemical studies have indicated that 40 to 60% of TNBCs~     exhibit EGFR expression and gene amplification was found in 18% of this subgroup,but EGFR~     mutation was rare in TNBC.~      By far,the role of gefitinib, an EGFR tyrosine kinase inhibitor(TKI),in the metastatic TNBC~     has not been identified. Most clinical trials about EGFR TKIs in the breast cancer have one~     or more limitations including:1) the study population had received heavily pretreatment;~     2)the enrolled patients included several subgroups of breast cancer; 3)the expression of EGFR~     was not clear in the enrolled patients.~      Here, the investigators launch a prospective clinical trial, and about 50 patients with~     triple-negative,EGFR positive metastatic breast cancer that have received at least second~     line therapy will be enrolled. these patients will be treated with gefitinib, the toxicity~     and effects of gefitinib will be recorded prospectively to evaluate the role of gefitinib in~     the metastatic TNBC.~   "
140196|NCT01732263|"~     The purpose of this study is to evaluate how much of the study drug SSP-004184 (SPD602) is~     absorbed by the body and how long it takes to be eliminated from the body in healthy subjects~     and subjects with mild, moderate, and severe hepatic (liver) impairment compared with~     subjects with healthy normal liver function.~   "
140197|NCT01732250|"~     The purpose of this study is to determine whether the addition of meropenem to colistin is~     better than colistin alone in the treatment of clinically significant infections caused by~     multi-drug resistant bacteria~   "
140198|NCT01732237|"~     The purpose of the study is to investigate the pharmacokinetics (what the body does to the~     medication) of JNJ-42396302, JNJ-53773187 and JNJ-42692507 after administration of a single~     oral dose of 100 micrograms under fasted conditions in healthy male participants.~   "
140199|NCT01732224|"~     The relevant data will be prospectively collected included patient demographics, clinical,~     all laboratory variables including virological tests, genotyping by direct sequencing,~     abdominal ultrasound, and upper gastrointestinal (GI) endoscopy. Trans jugular liver biopsy~     (TJLB) and hepatic venous pressure gradient (HVPG) will be done in patients when it was not~     evident whether the underlying liver disease was chronic based on clinical, biochemical,~     radiological investigations, and upper GI endoscopy. Severity of the liver disease will be~     assessed by Child-Turcotte Pugh score (CTP) and model for end stage liver disease (MELD)~     score.~   "
140200|NCT01732211|"~     The study proposes to evaluate the safety, tolerability, and efficacy of PD 0360324 in~     subjects with chronic pulmonary sarcoidosis inadequately treated with standard of care~     therapies.~   "
140201|NCT01732198|"~     Evaluate the safety and tolerability of a single booster dose of NU300, co-administered with~     Prevnar 13® over a 28 day period following the injection compared to a single booster of~     ACTHIB co-administered with Prevnar 13® over a 28 day period following the injection.~      Evaluate the immunogenicity, as determined by anti-PRP polysaccharide response, of a single~     booster dose of NU300 co-administered with Prevnar 13® compared to a single booster dose of~     ActHIB® co-administered with Prevnar 13®.~      Evaluate the individual IgG antibody quantitative response to the 13 antigens in Prevnar 13®~     following NU300 co-administration with Prevnar 13® compared to the IgG antibody response to~     the pneumococcal polysaccharides following ActHIB® co-administration with Prevnar 13® 28 days~     following injection.~   "
140202|NCT01732185|"~     The aim of this study is to identify genetic abnormalities and molecular pathways associated~     with the occurrence of CCAM.~   "
140203|NCT01732172|"~     Men following after proven and treated urethritis, looking for signs of chronic genital~     inflammatory syndrome with oxidative stress.~      This group of patients will be compared to a control group with no urethritis and no history~     of urogenital infection. Monocentric, prospective trial.~      Duration of study : one year~   "
140204|NCT01732159|"~     The purpose of this study is to evaluate the impact of a check list on the rate of late~     cancellation, i.e. the day before or the day of the ambulatory surgery.~   "
140205|NCT01732146|"~     The purpose of this study is to determine the efficacy of high dose Erythropoietin to improve~     survival and neurologic outcome in asphyxiated term newborn undergoing cooling.~   "
140206|NCT01732133|"~     Hypotension after spinal anesthesia for cesarean delivery occurs frequently. Oscillometric~     measurement gives intermittent informations. Nexfin, a continuous noninvasive device, could~     help to detect hypotension.~   "
140207|NCT01732120|"~     The purpose of this research study is to compare the effects on kidney function after~     performing the removal of a kidney tumor with or without clamping the blood vessels during~     surgery.~   "
140208|NCT01732107|"~     This trial will assess the 6-month complete response rate and toxicity profile of oral~     dovitinib therapy in BCG-refractory urothelial carcinoma patients with tumors with FGFR3~     mutations or over-expression who are ineligible for or refusing cystectomy.~   "
140209|NCT01732094|"~     The purpose of the present study is to examine the level of ovarian response and the~     pregnancy rates among poor ovarian responders treated with a novel treatment protocol with~     150μg corifollitropin alfa followed by 300IU hMG in a long GnRH agonist protocol.~   "
140210|NCT01732081|"~     It is estimated that 350-400 million people worldwide are chronically infected with hepatitis~     B virus (HBV). Cirrhosis and hepatocellular carcinoma are major complications of chronic HBV~     infection and are responsible of about 500,000 deaths each year. Although some predictive~     factors of the outcome of chronic HBV infection were reported, it remains needed to more~     precisely determine the factors which are associated with the outcome in non-selected~     patients. Indeed, these factors should help to identify patients who are likely to have a~     better or worse evolution of their chronic HBV infection over time and thus, to adapt their~     clinical management and monitoring.Therefore, our purpose is to constitute a real-life~     cohort of non-selected patients to create a database of epidemiological, clinical,~     biological, virological and therapeutic parameters, in order to determine factors associated~     with the outcome of chronic HBV infection.~   "
141867|NCT01710345|"~     This is a dose-finding study to determine if the sublingual administration of the Sufentanil~     NanoTab is safe and effective in the treatment of post-operative pain.~   "
140212|NCT01732055|"~     Purpose: To compare a novel psychotherapy, Partner-Assisted Interpersonal Psychotherapy~     (PA-IPT), with treatment as usual (TAU) in a sample of pregnant women seeking treatment for~     Major Depressive Disorder (MDD) at the University of North Carolina at Chapel Hill (UNC-CH)~     Perinatal Psychiatry Program.~      Participants: 52 women, ages 18-45, who are 16-29 weeks pregnant and experiencing a~     depressive episode, and their partners.~      Methods: Women and their identified partners will complete a diagnostic interview, complete~     measures of depressive symptom severity at baseline, and be randomized to treatment with~     PA-IPT or TAU. Women randomized to TAU will be treated by UNC physicians according to the~     UNC-CH Perinatal Psychiatry Program's algorithm for treatment of prenatal MDD (usually one of~     a number of antidepressant medications, tailored to the individual, although some women may~     opt against medication altogether and still be eligible to enroll). Women randomized to~     PA-IPT will participate in 8 therapy sessions with their identified partner over a 12-week~     period, along with one refresher session at or around 6 weeks postpartum. Women and partners~     will be assessed for change in depressive symptoms and relationship satisfaction during~     pregnancy at visits 4 and 8, and postpartum at 6-week and 6-month visits.~      Hypothesis: The investigators anticipate notable improvement in both groups similar in~     magnitude, however it is hypothesized that couples participating in PA-IPT will have higher~     relationship satisfaction post-treatment (controlling for baseline satisfaction) than those~     receiving TAU.~   "
140213|NCT01732042|"~     Determinate the standard values of the retinal venous pressure in a cohort of healthy~     subjects.~   "
140214|NCT01732029|"~     Pulse oximetry is a standard non-invasive method of measuring blood oxygen saturation (SpO2).~     In developing countries, pulse oximeters are rare because of expense and electricity~     requirements. Our ECEM group has developed the Phone Oximeter, which uses a cell phone (which~     are widely available in developing countries) to compute and analyze information from a pulse~     oximeter sensor. To further reduce costs, we have developed an oximeter sensor (AudioOx) that~     plugs into the audio jack of a standard cell phone. This study aims to calibrate the AudioOx~     by exposing 30 healthy adult volunteers to various altitudes in UBC's hypoxia chamber.~   "
140215|NCT01732016|"~     Pulse oximetry is a standard non-invasive method of measuring blood oxygen saturation (SpO2).~     In developing countries, pulse oximeters are rare because of expense and electricity~     requirements. Our ECEM group has developed the Phone Oximeter, which uses a cell phone~     (widely available in developing countries) to compute and analyze information from a pulse~     oximeter sensor. To further reduce costs, we use the integrated flashlight of a cell phone's~     camera to extract SpO2 (Camera Oximeter), eliminating the need for external hardware. This~     study aims to calibrate the Camera Oximeter by exposing 30 healthy adult volunteers to~     various altitudes in UBC's hypoxia chamber.~   "
140216|NCT01732003|"~     The biological membranes that surround a cell and its organelles are vital to the overall~     function of the cell. Fatty acids are the main structural component of membranes, and the~     presence of specific fatty acids can alter a membrane's characteristics, which subsequently~     alters function. Two fatty acids that are of particular interest to researchers are~     eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). These omega-3 fatty acids have~     unique unsaturated structures, and their incorporation into biological membranes appear to~     elicit potent physiological effects. The body is unable to intrinsically synthesize these~     important fatty acids, so they must be obtained from the diet or through supplementation.~      Compared to research investigating other body tissues, the effect of EPA and DHA on skeletal~     muscle membranes and cellular function has received little attention. Of the studies done,~     EPA and DHA supplementation consistently results in increased EPA, DHA, and total omega-3~     fatty acid content in the skeletal muscle membranes of rodents. One study has also~     demonstrated this effect in humans. These studies, however, have been limited to whole muscle~     measurements, yet cells contain numerous subcellular membranes with diverse functions. Two~     membranes of key importance to the metabolic function of a skeletal muscle cell are the~     membrane that surrounds the cell (plasma membrane), and the membrane that surrounds the~     mitochondria.~      The plasma and mitochondrial membranes are responsible for taking up nutrients and converting~     them into useable energy for the muscle. Recent findings suggest that physiological changes~     in these processes may occur following EPA and DHA supplementation. At rest and during~     exercise, there is potential for a shift in substrate selection that favors fat utilization~     following EPA and DHA supplementation. Several membrane proteins are responsible for~     transporting fat into the cell and mitochondria. The presence of EPA and DHA within membranes~     has the potential to affect the membrane integration and function of proteins. The~     investigators aim to determine whether fat utilization increases following EPA and DHA~     supplementation, and if there is a concurrent change in the concentrations of fat transport~     proteins within plasma and mitochondrial membranes. Supplementation with EPA and DHA may also~     affect oxygen consumption, an important process in energy production that is regulated by~     mitochondrial membrane proteins. Evidence from human and rodent studies shows a decrease in~     whole body oxygen consumption following supplementation. The investigators aim to examine~     these changes directly by measuring mitochondrial respiration following EPA and DHA~     supplementation.~      Therefore, the primary purpose of this study is to examine how plasma and mitochondrial~     membrane fatty acid composition change individually in response to EPA and DHA~     supplementation in humans. The secondary purpose of this study is to examine functional~     metabolic changes that occur in skeletal muscle in response to EPA and DHA supplementation,~     and to investigate correlational relationships between these changes and any compositional~     alterations in plasma and mitochondrial membranes. The investigators hypothesize that~     supplementation with EPA and DHA will alter fuel selection at rest and during exercise, and~     this will correspond to an increase in the concentration of membrane fatty acid transport~     proteins, and that these changes will correlate to an increase in the EPA, DHA, and total~     omega-3 content of plasma and mitochondrial membranes.~   "
140217|NCT01731990|"~     This study was designed to assess the safety, tolerability and efficacy of ACZ885 on the leg~     artery structure and physical activity in patients with atherosclerotic peripheral artery~     disease and leg pain from walking.~   "
140218|NCT01731977|"~     The onset of Psychosis forces family members to bear a heavy burden of care. The mental~     well-being of the family is so complicated that it is important to relieve their~     psychological stresses. Although family psychoeducation has been established as an~     evidence-based practice especially for schizophrenia, few studies have primarily intended to~     reduce the distress of the family due to the burden of care. MacFarlane's multifamily~     psychoeducation is one of the representative models of a group setting, which is based on the~     behavioral therapeutic approach. In such psychological interventions, it has been emphasized~     to focus on the strengths that a person originally has for coping with difficulties. The~     intervention of mainly drawing the strengths from the family might empower them and lighten~     their psychological burden.~      The first 2-5 years from the onset of psychosis is regarded as the critical period to improve~     the prognosis, so the intervention including more recent-onset psychotic patients might be of~     use. With regard to a setting of the psychoeducational intervention, a homogeneous group one~     can make the program better fitted for their problems. The present study aims to examine if~     the strength-based family psychoeducaiton for youth psychosis in a group setting in addition~     to the treatment as usual would be more effective for alleviating the psychological~     distresses of the family than the treatment as usual alone. Moreover, its impact on the~     family of recent-onset psychosis is explored as the subgroup.~   "
140219|NCT01731964|"~     This is a pilot study to evaluate the safety of the Model WA-NG telescope prosthesis in~     patients with bilateral moderate to profound central vision impairment due to end-stage~     age-related macular degeneration.~   "
140220|NCT01731951|"~     This pilot clinical trial studies how well imetelstat sodium works in treating patients with~     primary or secondary myelofibrosis and other myeloid malignancies. Imetelstat sodium may stop~     the growth of cancer cells by blocking some of the enzymes needed for cell growth~   "
140221|NCT01731938|"~     This study is designed to assess the safety and efficacy of fibrin sealant (FS) Grifols in~     patients undergoing elective (non-emergency) soft tissue open surgery where bleeding may be~     present. The purpose of this study is to demonstrate that FS Grifols is not inferior to~     commercially-available oxidized cellulose pads (Surgicel®) in providing benefit in the time~     to hemostasis (i.e, the stoppage of bleeding). This study has a Preliminary Part (I) for~     study teams to become familiar with the application of FS Grifols and a Primary Part (II) to~     assess the safety and efficacy of FS Grifols. In both parts of the study, patients will be~     randomized in a 1:1 ratio to either FS Grifols or Surgicel.~   "
140222|NCT01731925|"~     Sunitinib may provide an opportunity for a novel therapeutic strategy for the treatment of~     subjects with neuroendocrine tumors.~   "
140223|NCT01731912|"~     This pilot clinical trial studies how well degarelix acetate before and during radiation~     therapy works in treating patients with prostate cancer. Androgens can cause the growth of~     prostate cancer cells. Drugs, such as degarelix acetate, may lessen the amount of androgens~     made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink~     tumors. Giving degarelix acetate together with radiation therapy may work better in treating~     prostate cancer.~   "
140224|NCT01731899|"~     Depression and unrefreshed sleep are frequent in patients with fibromyalgia. Agomelatine is a~     new antidepressant with sleep-promoting properties. The objective of this study include the~     assessment of agomelatine therapy in patients with depression and fibromyalgia both on the~     severity of depressive symptomatology and sleep quality.~   "
140225|NCT01731886|"~     The study is being done to compare the combination of lenalidomide and dexamethasone followed~     by autologous peripheral blood stem cell transplant (PBSCT) and lenalidomide and~     dexamethasone without PBSCT in patients with untreated multiple myeloma. This comparison will~     include how the subjects respond to each study treatment combination, and what side effects~     are caused by each combination.~   "
140226|NCT01731873|"~     The purpose of this research study is to identify factors and genes (the nucleic acid~     material that determines the makeup of the human body) that may be associated with how~     children respond to pain medication, like morphine, which are called opioids. Though these~     pain medicines are used every day, some children have bad reactions from their use, like~     breathing problems, sedation, etc. It is not possible to completely predict which pain~     medicine is 'right' for a child. The investigators want to study factors that may be~     associated with pain sensitivity, pain medicine requirements after surgery, and their~     side-effects. The investigators expect that the information obtained in this research study~     will help to develop effective, safer, and tailored treatment options in the future.~   "
140227|NCT01731860|"~     A standard PET/CT scanner is comprised of two different machines: An X-ray computed~     tomography scanner (CT), which gives information about your anatomy, and a Positron Emission~     Tomography scanner (PET) that provides information about how the body functions. Both of~     these work together to make the final images for doctors to review. As part of this research~     study the investigators would like to test a new scanner technology by evaluating the quality~     of the images obtained using this new PET system.~      The scanner the investigators would use is able to do both types of examination, the standard~     PET/CT and the additional research PET. The new PET system adds a second scanner ring to the~     standard PET/CT. This allows the patient to stay on the same imaging table for both studies.~     Being in this study does not change how the standard PET/CT will be done.~   "
140228|NCT01731847|"~     The investigators aimed to evaluate effects of combined NMES, FEES and traditional swallowing~     rehabilitation in stroke patients with moderate-to-severe dysphagia.~   "
140229|NCT01731834|"~     There may be pain and / or stress with vibrocompression. There may be pain and / or stress~     with the aspiration of secretions.~   "
140230|NCT01731821|"~     Pancreaticojejunostomy is the key procedure of pancreaticoduodenectomy. The aim of our study~     is to investigate a new pancreaticojejunal (PJ) anastomosis procedure named nonstented~     stump-closed pancreaticojejunostomy in pancreatoduodenectomy, which could provide a feasible~     option to pancreatic surgeons for patients with pancreaticoduodenectomy.~   "
140231|NCT01731808|"~     The purpose of the study is to evaluate the feasibility and effectiveness of a physician~     directed nurse managed earlier outpatient counselling intervention for patients with diabetic~     foot ulceration.~      For the purpose effectiveness is defined in two ways.1) as a reduction in hospital~     readmissions for complication for foot ulcers such as amputation or increased severity of the~     ulcer and 2) reduction in amputations, readmission rates. Selected covariates~     (self-efficacy,self-management, social support and depression) will be included to estimate~     predictors for readmission and amputation.~   "
140232|NCT01731795|"~     BACKGROUND: Currently, there is no proven pharmacologic treatment for patients with the acute~     respiratory distress syndrome (ARDS). Great interest remains in the use of corticosteroids~     for the salvage of patients with severe acute lung injury in the early phase of their disease~     process, a situation that that has not been evaluated in most published trials. Dexamethasone~     has never been evaluated in ARDS in a randomized controlled fashion.~      HYPOTHESIS AND OBJECTIVES: The investigators hypothesize that adjunctive treatment with~     intravenous dexamethasone of patients with established ARDS might change the pulmonary and~     systemic inflammatory response and thereby will increase the number of ventilator-free days~     and will decrease the extremely high overall mortality. Our goal is to examine the effects of~     dexamethasone on length of duration of mechanical ventilation (assessed by number of~     ventilator-free days) and on mortality, in patients admitted into a network of Spanish~     intensive care units (ICUs) who still meet ARDS criteria at 24 hours after ARDS onset.~   "
140247|NCT01731587|"~     Phase Ib study investigating whether liposome BLP25 mucin-1 (MUC1) peptide-specific~     immunotherapy (L-BLP25) administered as weekly subcutaneous doses over 8 weeks following a~     single dose of intravenous cyclophosphamide (CPA) induces a reproducible cytokine pattern~     measured in the serum of unresected Stage III non-small cell lung cancer (NSCLC) subjects~     after first-line chemo-radiation therapy.~   "
140248|NCT01731574|"~     This trial will investigate the potential drug-drug interaction between dapivirine vaginal~     Ring-004 and vaginally administered miconazole nitrate, and will evaluate the safety of~     co-administration of the dapivirine vaginal ring and miconazole nitrate in healthy,~     HIV-negative women.~   "
141868|NCT01710332|"~     A preliminary study to determine the safety and efficacy of intravitreal aflibercept~     injection in patients with persistent central serous chorioretinopathy.~   "
140233|NCT01731782|"~     Patients experience pain after surgery mostly from their abdominal wounds, even when those~     wounds are small. Decreasing that pain has many benefits. It improves comfort, decreases~     stress response and might improve the outcome of the surgery. Local anesthesia (which is a~     numbing agent given directly at the site of pain via a needle) is given to decrease the pain~     that is felt after surgery and decrease the need for strong pain medications which can have~     negative side effects.~      One promising way to give local pain medication is called the transversus abdominis plane~     or TAP block. This method works by directly blocking the nerves in the abdomen that are the~     cause of the pain patients feel in their incision after surgery. This is done by injecting a~     numbing agent (Bupivacaine) into the area of their abdomen where their nerves are located~     that cause pain.~      In the case of nerves that carry sensation, bupivacaine blocks the pain sensation traveling~     in a particular nerve.~      Patients will be randomized (like a flip of a coin) to receive either a normal saline~     injection or the bupivacaine injection.~      The purpose of this study will be to prove the effectiveness of local anesthetic given via a~     TAP block in improving postoperative pain, decreasing the use of pain medications, decreasing~     postoperative nausea and vomiting and improve surgical outcomes such as hospital length of~     stay in laparoscopic colorectal surgery.~   "
140234|NCT01731769|"~     Axillary dissection is the standard treatment for breast cancer patients with positive nodes.~     However, seroma formation after axillary dissection remains the most common early~     complication to breast cancer surgery. It can delay the initiation of adjuvant therapy,~     predispose to wound infection, delay wound healing and has also been linked to arm~     lymphoedema. Based on some studies and our experience that vacuum assisted closure （VAC）is~     effective in complex wound failures following axillary dissection and groin dissection, we~     use VAC to prevent seroma formation after extensive axillary dissection. This study is aimed~     to evaluate the efficacy, safety and economics benefits of early VAC application on~     postoperative complications and wound healing after extensive axillary dissection in~     comparison to conventional suction drain.~   "
140235|NCT01731756|"~     Effects of leaf extract of Azadirachta indica in palmer arsenical keratosis: Randomized,~     double-blind, placebo-control trial~   "
140236|NCT01731743|"~     The purpose of the study is to evaluate the far, intermediate and near visual acuities with a~     trifocal IOL.~   "
140237|NCT01731730|"~     The objectives of this proof of concept study are to evaluate the safety and preventive~     analgesic efficacy of a single preoperative intrathecal administration of AYX1 Injection in~     patients undergoing unilateral total knee arthroplasty.~   "
140238|NCT01731717|"~     The main aim of the project is the implementation and evaluation of a stepped care model~     (SCM) for patients with depression with 6 treatment options of varying intensity and setting,~     including innovative technologies (e-mental health, telephone-based psychotherapy). Within~     this complex intervention, patients are treated by a multiprofessional network of health care~     providers in Hamburg, Germany. The study compares the SCM condition (intervention group) to a~     control group receiving treatment as usual (cluster randomization on the level of~     participating general practitioners). It is expected that the SCM condition will show better~     results regarding reduction of mental symptoms, improvement of quality of life, more~     efficient access to care and better cost-benefit ratio.~   "
140239|NCT01731704|"~     This is randomized study of neurocognitive outcomes in patients with five or more brain~     metastases treated with stereotactic radiosurgery (SRS), specifically the Gamma Knife (GK)~     system, or whole-brain radiation therapy (WBRT). The primary aim of this study is to compare~     the change in neurocognitive function outcome between baseline and 6 months in WBRT versus~     SRS treatment groups.~   "
140240|NCT01731691|"~     Our primary objective is to further characterize the mechanism by which alpha-1PI regulates~     CD4 counts.~      HIV-1 infected patients will be initiated on PROLASTIN®-C (Alpha-1 Proteinase Inhibitor~     [Human], Grifols Biotherapeutics Inc.) or placebo. Uninfected volunteers will be untreated~     and will be monitored for comparison.~   "
140241|NCT01731678|"~     Major depression (or MDD) in adolescents is a major public health problem. MDD affects~     approximately 15% of adolescents; it is associated with impairment in social, family, and~     academic functioning, and it is a major risk factor for suicide - a leading cause of death in~     adolescents . Unfortunately, there is a paucity of treatment options for this age group.~     Selective serotonin reuptake inhibitors (SSRIs) are the only class of medications approved~     for treating MDD in adolescents, but rates of remission following treatment with SSRIs are~     only 30 to 45 percent. Cognitive behavior therapy is associated with similar remission rates~     and access is limited. Most adolescents will require more than one therapeutic intervention~     in order to achieve full symptom control. Collectively, there is overwhelming evidence that~     additional treatment options are urgently needed to improve outcomes for teens with MDD. One~     novel treatment for adolescent MDD is repetitive transcranial magnetic stimulation (rTMS).~     Studies in children have been limited (a total of 23 cases). This is surprising given the~     evidence suggesting younger adult subjects with MDD respond better to rTMS (56% response~     rate) than older subjects. This limited experience with rTMS for adolescent MDD represents a~     substantial gap in the knowledge, recently recognized in publications calling for further~     study of rTMS in adolescent depression. Most importantly, the mechanism of action of rTMS in~     adolescent MDD is not well understood. The objective of this application is to develop an~     understanding of the brain alterations associated with the positive clinical changes that~     occur with rTMS in adolescent MDD. Such knowledge will provide the basis for pursuing rTMS~     for adolescent MDD as a rational therapeutic technique.~      Specific Aim: To compare the effect of rTMS on DLPFC glutamate concentration in adolescent~     MDD. The investigators hypothesize an increase (normalization to controls) in DLPFC glutamate~     after three weeks of rTMS. Furthermore, the change in glutamate concentration will correlate~     with a change in MDD symptoms.~   "
140242|NCT01731665|"~     The purpose of this study is to evaluate the incidence, prevalence, clinical characteristics~     and prognosis of Crohn's disease and ulcerative colitis over time in a district of Seoul,~     Korea.~   "
140243|NCT01731652|"~     This is a Phase II pilot study to explore the effect of intravesical TMX-101 in patients with~     CIS bladder cancer, as assessed by histology and cytology after TMX-101 treatment.~   "
140244|NCT01731639|"~     A new technique based on the motile sperm organelle morphology examination (MSOME) at a~     magnification of at least ×6000 has been developed. The MSOME assesses the nucleus, for both~     shape and chromatin content, which is the most important sperm organelle in influencing~     intracytoplasmic sperm injection (ICSI) outcomes.~   "
140245|NCT01731613|"~     This clinical trial will compare how the individualized and fortified human milk feeding will~     help a premature infant grow.~   "
140246|NCT01731600|"~     This trial is conducted globally. The aim of the trial is to investigate safety, efficacy and~     pharmacokinetics (the exposure of the trial drug in the body) of NNC 0129-0000-1003 (N8-GP)~     in children with severe haemophilia A who have undergone treatment with previous factor VIII~     (FVIII) products.~   "
140249|NCT01731561|"~     The aim of this study is to assess the efficacy of a rituximab regimen based on rate of ANCA~     and CD19 lymphocytes for maintenance treatment in systemic ANCA-associated vasculitis:~     prospective, multicenter, controlled, randomized comparative study of two rituximab regimens:~     one based on ANCA and CD19 lymphocytes versus systematic infusions.~   "
140250|NCT01731548|"~     We hypothesized that the local control for both arms were not statistically significant, when~     irradiation to the post-induction chemotherapy tumor volume is compared with irradiation to~     the pre-induction chemotherapy tumor volume.While elective nodal irradiation will be omitted~     for both arms.~   "
140251|NCT01731535|"~     Dose and duration of bisphosphonate therapy will increase the likelihood that patients~     experience delayed healing of non-union fractures.~   "
140252|NCT01731522|"~     The purpose of this study is to examine the influence of two Eating Frequency prescriptions,~     meal (energy intake occurring during three meals per day) and grazing (energy intake~     occurring every two to three hours per day), on consumption during an ad libitum meal~     consumed at the end of the day, overall daily energy intake, and ratio of energy intake to~     energy expenditure. It is hypothesized that the grazing condition will produce lower~     consumption during an evening ad libitum meal, lower daily energy intake, and a lower ratio~     of energy intake to energy expenditure than the meal condition.~   "
140253|NCT01731509|"~     Congenital diaphragmatic hernia (CDH) is associated high mortality and morbidity, mainly in~     those cases with severe forms where there are extremely reduced lung volumes, liver~     herniation and decreased abnormal pulmonary vascularization. Fetal endoscopic tracheal~     occlusion performed between 26 and 30 weeks (standard FETO) has been shown to increase fetal~     pulmonary size and vascularity, and to improve infant survival in isolated severe CDH. Fetal~     pulmonary response followed FETO can be used to predict outcome and is dependent on the size~     of the fetal lung prior to the procedure.~      We hypothesize that performing an earlier FETO, between 22-24 weeks, fetuses with severe form~     of CDH will have a better fetal pulmonary response and higher chance of surviving.~   "
140254|NCT01731496|"~     The human papillomavirus (HPV) vaccine is routinely recommended for both adolescent girls and~     boys starting at age 11, although it can be offered as young as 9 years of age. This is a~     3-dose series and many adolescents do not complete it after getting the first dose. This~     study will study how effective it will be to send reminders to parents to schedule an~     appointment when their child is due for the next dose of HPV. Parents can chose whether they~     would like a phone call or text message reminder. This study will determine if the reminders~     work, and if one method is better than another (phone message vs. text message).~   "
140255|NCT01731483|"~     the aim of this study is to investigate the role of staphylokinase, streptokinase and MMP~     activation in invasive staphylococcal and streptococcal infections.~   "
140256|NCT01731470|"~     Interstitial cystitis/painful bladder syndrome (IC/PBS) is a poorly understood chronic~     disorder of unknown etiology consisting of irritative bladder symptoms and pelvic pain that~     dramatically affects quality of life.~      Preclinical study data (obtained by using an IC/PBS model in Sprague-Dawley female rats) have~     demonstrated normalization of urinary frequency indicating that LP may be a potent protectant~     of the bladder mucosa against inflammation and irritation. Intravesical LP has so far~     demonstrated an excellent safety profile and minimal toxicity at concentrations of 2 mg/ml.~     Thus, we hypothesize that intravesical instillation of LP may form a molecular film on~     bladder ulcer surfaces in patients with IC and provide a safe, effective, and minimally~     invasive treatment option to alleviating symptoms.~   "
140257|NCT01731457|"~     The aims of this study are:~        1. assessment of ischemia injury of kidney retrieved from standard and expanded criteria~          deceased donor before transplantation~        2. assessment of efficacy of kidney ischemia injury decreasing~        3. assessment of influence of kidney ischemia injury decreasing on its function after~          transplantation For the purpose of this research one hundred kidney will be retrieved~          from deceased donors (standard and expanded criteria deceased donors) for~          transplantation. All kidneys before transplantation will be stored in machine perfusion~          in hypothermia with continuous flow - Organ Recovery Systems LifePort - each single~          kidney in self-contained perfusion system.~      For the kidney allograft assessment will be used measurements performed during machine~     perfusion in hypothermia: renal flow, resistance, lactate dehydrogenase, lactates and~     ischemia injury markers measured in the fourth hour of perfusion in perfusion fluid.~      For kidney ischemia injury assessment such markers will be measured: tumour necrosis factor~     (TNF alfa), interleukin 2 (IL-2), interleukin 6 (IL-6), high sensitivity C-reactive protein~     (hsCRP), platelet-derived growth factor (PDGF), cystatin C, kidney Injury Molecule (KIM-1),~     neutrophil Gelatinase-associated Lipocalin (NGAL), complement component C3, caspase 3.~      Every time from pair of retrieved kidneys each kidney will be randomise for one of the group:~        -  group 1) - 50 kidneys - examined group - cured with etanercept (ENBREL) in the first~          hour of perfusion by adding drug to perfusion fluid,~        -  group 2) - 50 kidneys - control group - without intervention. Ischemia injury markers~          will be measured in perfusion fluid by kidney two times (in the first and fourth hour of~          perfusion) for assessment of efficacy kidney ischemia injury decreasing.~      Results of measurements of kidney ischemia injury before transplantation, parameters during~     machine perfusion in hypothermia and donor parameters will be correlated with kidney~     allograft function post transplantation.~      Immediate, delayed and slow graft function, primary non-function, kidney function assessed by~     creatinine concentration and creatinine clearance at one day, seven days, two weeks, 1, 6 and~     12 months post transplantation and kidney graft survival 6 and 12 months post transplantation~     will be analysed.~   "
140258|NCT01731444|"~     The standard of care for treatment of burn injury is to inject a solution of epinephrine~     under the skin of the injured site in order to reduce blood loss during skin grafting. This~     solution of epinephrine has been shown to have effects on the body outside the donor site.~     Some people have increases in heart rate and blood pressure. We will study the effect of a~     phenylephrine solution in place of an epinephrine solution to control blood loss. We think~     that phenylephrine will help decrease blood loss and not change blood pressure or heart rate.~      The injured area will be injected under the skin and a skin graft will be taken in the same~     way as we usually do. The only change will be the use of phenylephrine in the solution~     instead of epinephrine.~      Our goal is to find whether or not phenylephrine or epinephrine solution results in a~     reduction of blood loss without affecting the rest of the body.~   "
140259|NCT01731431|"~     This clinical trial aims to test whether glibenclamide is non-inferior to insulin for the~     treatment of gestational diabetes.~   "
140260|NCT01731418|"~     The proposed study seeks to investigate to what extent Narrative Exposure Therapy (NET) is an~     effective treatment for the reduction of symptoms of Post-Traumatic Stress Disorder (PTSD)~     and depression and for the improvement of daily functioning in Iranian women who have~     experienced intimate partner violence (IPV). In addition, the study seeks to investigate~     whether NET therapy could lead to the reduction of Intimate Partner Violence (IPV) within~     their marriage.~   "
140261|NCT01731405|"~     The purpose of this study is to determine the potential efficacy of three revised Medication~     Guide layouts to increase consumers' comprehension~   "
140262|NCT01731392|"~     To investigate the effect of milk-based formulas on infections and immune functions in~     healthy children.~   "
140263|NCT01731379|"~     Investigation of application possibilities of optical spectroscopy within the field of~     surgical resection procedures to spare nerve tissue. Optical spectroscopy enables the~     possibility to specifically differentiate between different (human) tissues. The hypothesis~     is that incorporation of this technique into existing medical devices (e.g. medical blade)~     would enlarge the accuracy and reliability of these devices. Sparing of nerve bundles during~     surgery can lead to decreased postoperative morbidity rates.~   "
140264|NCT01731366|"~     Objective: To identify how specific changes of the whole grain content in the diet affect the~     host-gut microbiome interactions with implications for metabolic health .~      Design: A randomized, controlled, single-blinded, cross-over intervention trial consisting of~     two 8-week intervention periods, separated by a 6-week wash-out period. A total of 60~     participants will be included.~      Intervention: low vs. high whole grain intake.~   "
140265|NCT01731353|"~     The objective of this registry is to broaden the knowledge on epidemiology, diagnostic~     procedures and clinical course of emerging invasive fungal infections.~   "
140266|NCT01731340|"~     The overarching aim of this randomized clinical trial is to estimate the effect of dietary~     intake of calcium as compared to supplemental calcium on the vascular system and markers of~     vascular and bone health in postmenopausal women.~   "
140267|NCT01731327|"~     This study will explore the drug behavior and safety following single doses of tofacitinib~     modified-release (MR) 11 mg and MR 22 mg in healthy volunteers.~   "
140268|NCT01731314|"~     This study investigates the learning and memory of pain.~   "
140269|NCT01731301|"~     1. A maximally tolerated dose of ribavirin can be defined in each patient with ESRD~          undergoing hemodialysis.~        2. Patients with Chronic Hepatitis C Virus (HCV)and End-Stage Renal Disease~          (ESRD)undergoing hemodialysis will be able to tolerate and remain on treatment with~          peginterferon alfa-2b, the maximally tolerated dose of ribavirin and boceprevir.~        3. A significant percentage of patients with chronic HCV and ESRD undergoing hemodialysis~          can achieve rapid virologic response (RVR), extended virologic response (eRVR) and~          sustained virologic response (SVR) when treated with peginterferon alfa-2b, the~          maximally tolerated dose of ribavirin and boceprevir.~   "
140270|NCT01731288|"~     The main purpose of this study is to assess conception, pregnancy, childbirth, and pain~     experiences among women who have been diagnosed with vulvodynia. Specifically, this study~     aims to examine the following among women who have been diagnosed with vulvodynia: 1) rates~     of pregnancy/childbirth and desire for children; 2) fear of pregnancy and childbirth; 3)~     potential difficulties experienced while attempting to become pregnant and during~     pregnancy/childbirth; 4) methods used to become pregnant and deliver; 5) methods used to~     manage vulvodynia symptoms during pregnancy; and 6) pain outcomes associated with pregnancy.~      Very little research has examined pregnancy/childbirth experiences among women with~     vulvodynia, or the natural history of vulvodynia. As such this is a preliminary investigation~     that will provide descriptive information regarding many of the proposed research questions.~     Based on the clinical experience of the investigators, it is expected that women with~     vulvodynia will report lower rates of pregnancy and higher levels of fear about pregnancy and~     childbirth in comparison to women without such pain. It is also expected that women with~     vulvodynia will report more difficulties becoming pregnant as compared to women without such~     pain, and that women with vulvodynia will report more elective nonvaginal births in~     comparison to vaginal births.~   "
140271|NCT01731275|"~     To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single~     ascending dose (SAD) administration of E6011 in Japanese healthy volunteers.~   "
140272|NCT01731262|"~     Rheumatoid arthritis(RA) with a high incidence and high morbidity, the pathogenesis has not~     been fully elucidated. Fibroblast-like synovial cells excessive proliferation and synovial~     angiogenesis is the most important cause of RA synovitis and joint destruction. Our study was~     to find the role of Sonic Hedgehog(SHH) pathway in regulating proliferation of~     fibroblast-like synovial cells and modulating excess angiogenesis of synovial tissue.~   "
140273|NCT01731249|"~     The purpose of this 2-year study is to assess the sustained clinical efficacy and safety of~     300 IR/day of a sublingual solution of birch pollen allergen extract starting 4 months prior~     to the birch pollen season and continuing over the birch pollen season compared with placebo~     for reduction of rhinoconjunctivitis-related symptoms and anti-allergy medication usage.~   "
140274|NCT01731236|"~     The principal goal for the study is to examine the role gut flora plays in modulating~     metabolism of dietary carnitine and choline in humans.~   "
140275|NCT01731223|"~     The aim of this study is to analyze if group treatment is effective to treat insomnia in~     primary healthcare.~   "
140276|NCT01731210|"~     The LENEA study is an international, prospective, open label, non-randomized multicenter~     clinical research study designed to assess the safety and effectiveness of the NANO LV lead~     system.~   "
140277|NCT01731197|"~     Proteins are known to be more satiating than the other macronutrients; however, the type and~     amount of protein needed to induce a significant effect on satiety (fullness between meals)~     is sometimes difficult to determine. In this study, 2 differentially processed isolated soy~     proteins will be tested for satiety using subjective visual analogue scales. The amount of~     food consumed following intake of the isolated soy proteins will be measured 3 hours after~     consuming the proteins. The hypothesis is that differentially processed isolated soy proteins~     will show unique satiety responses.~   "
140278|NCT01731184|"~     Administration of midazolam with morphine in patients with severe acute pain is a routine~     practice in the management of pre- and post-operative patients but has not been evaluated in~     pre-hospital setting. The investigators aim to evaluate the co-analgesic effect of midazolam~     in the pre-hospital management of traumatic patients with severe acute pain.~      In a multicenter prospective randomized double-blind placebo-controlled trial, the~     investigators would like to compare the analgesic effect and safety of the intravenous~     morphine 0.10 mg/kg and midazolam 0.04 mg/kg with the intravenous morphine 0.10 mg/kg and~     placebo in pre-hospital traumatic adults. Assessment will be done at the baseline using a~     validated numeric rating scale (NRS).~      The primary outcome will be the proportion of patients with a pain score less than or equal~     to 3 after 20 minutes. The secondary outcomes will be in between-group comparison of: the~     treatment safety, pain score every 5 minutes during 30 minutes and the total morphine dose~     required until obtaining a pain score less than or equal to 3.~   "
140279|NCT01731171|"~     The purpose of this study is to determine if taking a probiotic supplement versus a placebo~     will lower rates of relapse and improve the clinical course among participants who have been~     hospitalized for mania. Relapse and clinical course are measured by time to~     re-hospitalizations, new mood episodes, and changes in mood-related symptoms.~   "
140280|NCT01731158|"~     This will be a prospective, open label, randomized multicenter phase-II study to evaluate~     progression free survival (PFS) in 2nd line treatment in patients with locally advanced or~     metastatic clear-cell renal cell cancer (cc-RCC) receiving everolimus (arm A) in comparison~     to a tyrosine-kinase inhibitor (TKI) (arm B). Following 2nd line treatment, patients will be~     switched to a TKI in arm A and everolimus in arm B. All patients will receive bevacizumab as~     standardized first-line treatment.~      Another key element of the study is the analysis of predictive biomarkers, which will be~     performed in serum and tumor tissue, respectively. Serum samples will be collected at~     prespecified timepoints throughout the study and analysed by SELDI-TOF-MS and DIGE. Candidate~     proteins are thought to predict therapeutic outcome and candidates are subject for target~     validation by Western Blot or ELISA. In addition, formalin-fixed paraffin-embedded (FFPE)~     tumor tissue will be collected prospectively and analysed for micro RNA (miRNA). Candidate~     miRNAs that predict therapeutic outcome will be validated by quantitative RT-PCR.~     Furthermore, circulating tumor cells (CTCs) will be generated from blood drawings during~     routine visits. The primary objective is to correlate the marker profile defined from the~     FFPE tissue with the profile obtained from CTCs in order to validate expression based markers~     ant their change during different treatment lines.~   "
140281|NCT01731145|"~     The purpose of this study is to record and measure tremor using portable six-axis (tri-axial~     accelerometer and tri-axial gyroscope) motion sensing system.~   "
140282|NCT01731132|"~     Knowledge about the impact on quality of life of women initiating IUD in the Spanish~     population at baseline and after 12 months of use.~   "
140283|NCT01731119|"~     The overarching purpose of this pilot study is to collect preliminary data regarding the~     variability of weight gain associated with lurasidone (Latuda©) treatment of antipsychotic~     naive children and adolescents in order to inform decisions about including a lurasidone arm~     in a future large scale trial of different approaches to minimize antipsychotic associated~     weight gain in the pediatric population. In adults, lurasidone appears to cause minimal~     weight gain. The participants will be 6-19 years old with psychotic spectrum, mood spectrum,~     or autism spectrum disorders. They will have 4 weeks or less of lifetime antipsychotic~     exposure.~   "
140284|NCT01731106|"~     Brief Summary Cerebral Autoregulation is a well known physiological response to blood~     pressure changes to maintain the cerebral perfusion. The critically ill patients are~     submitted to different situations that can impair the cerebral autoregulation as sepsis,~     sedation drugs and mechanical ventilation.~      The delirium on ICU has been described as a bad prognosis factor, increasing the mortality~     and length of stay. The physiopathology of delirium has been related to cerebral perfusion.~     The delirium has been related to long term cognitive impairment.~      Material and Methods:~      This is a physiological prospective study that will be done in a 14 bed medical-surgical ICU.~     The investigators will enroll 100 ventilated patients, septic and non-septic. The~     investigators will measure cerebral autoregulation every 48-72 hours from admission on ICU.~     Neurological biomarkers (Neurological Specific Enolase, S100 beta and Vascular Endothelial~     Growing Factor) will be done at inclusion, 72 hours and 7 days. Clinical data, delirium~     presence, analytic data and ventilatory parameters will be registered every day.~      At hospital discharge, a psychologist will do a cognitive evaluation using specific tests.~     The cognitive evaluation will be repeated at 3, 6 and 12 months.~      Anticipate results:~      Some items like mechanical ventilation, sepsis and sedation can impair cerebral~     autoregulation. The impairment of cerebral autoregulation is related to delirium in ICU and~     long cognitive impairment.~   "
140285|NCT01731093|"~     The purpose of this study is to determine the safety, bioavailability, and effectiveness of~     an organic yeast-selenium compound in reducing brain oxidative stress. Oxidative stress in~     the brain has been linked to a variety oif disorders including Alzheimer's disease. Selenium~     is a very powerful antioxidant that could prove useful in reducing the harmful effects of~     oxidative stress in the brain and may help prevent diseases such as Alzheimer's. Our recent~     work has demonstrated that the specific type of selenium compound greatly influences it's~     ability to enhance brain health and prevent Alzheimer changes in mouse models of this~     disease.~      This study will enroll 24 participants and will allow us to test the hypotheses that~     yeast-selenium supplementation is safe in the elderly, and that our specific formulation~     reduces brain oxidative stress.~   "
140286|NCT01731080|"~     Quantification and preferential sites of arterial wall calcification within the coronary and~     lower legs arteries will be comared between Pseudo-Xanthoma elasticum(PXE) atients and type 2~     diabetics and Chronic Kidney disease.~   "
140287|NCT01731067|"~     Phenotyping is an approach largely used for the evaluation of the activity of cytochromes and~     transporters in vivo. It consists of the administration of probe substances metabolised by a~     specific cytochrome or transported by P-glycoprotein (P-gp) for example, followed by the~     determination of a metabolic ratio or the evaluation of the plasmatic or urinary~     concentrations of the probe substances. The administration of a cocktail containing several~     probe substances allows the simultaneous evaluation of the activity of several cytochromes~     and P-gp in a single test.~      The aim of this project is the validation of a phenotyping cocktail of low dose probe drugs~     for the assessment of cytochrome P450 and P-gp activities by simple capillary blood sampling~     and dried blood spot (DBS) analysis. The cocktail consists of caffeine, bupropion,~     flurbiprofen, omeprazole, dextromethorphan, midazolam and fexofenadine for the simultaneous~     phenotyping of CYP1A2, CYP2B6, CYP2C9, CAP2C19, CYP2D6, CYP3A4 and P-gp, respectively.~      The modulation of the activity of cytochromes or P-gp will be evaluated by the administration~     of inhibitors (fluvoxamine, voriconazole, quinidine) or inducer (rifampicin) of the metabolic~     pathways or the P-gp mediated transport.~   "
140320|NCT01730638|"~     The aim of this study is to optimize pretargeting parameters using pharmacokinetic and~     imaging data for immuno-PET using anti-CEA x anti-HSG TF2 BsMAb and 150 MBq of 68Ga-IMP-288~     peptide in MTC patients with abnormal Ct serum level after initial complete surgery and at~     least one abnormal lesion~   "
140288|NCT01731054|"~     The primary objectives of the study are as follows: To develop and optimize a renal~     functional magnetic resonance imaging (MRI) protocol consisting of Diffusion-Weighted~     Magnetic Resonance Imaging (DW-MRI), Blood-Oxygen- Level-Dependent MRI (BOLD-MRI), Arterial~     Spin Labeling MRI (ASL-MRI), Phase Contrast MRI (PC-MRI), and T1rho-MRI; To compare renal~     functional MRI cross-sectional readouts between normal healthy volunteers (NHV) and lupus~     nephritis (LN) participants.~      The secondary objectives of this study are as follows: Explore whether renal functional MRI~     techniques discriminate between renal inflammatory activity and damage in lupus nephritis~     (LN); To examine whether renal functional MRI measurements correlate with laboratory features~     of renal involvement and renal function in participants with lupus nephritis (LN).~   "
140289|NCT01731041|"~     Platelets are parts of your blood that stick together to help form a clot. The stickier your~     platelets are, the greater your chance of having a heart attack. A clot in the wrong place~     can lead to a heart attack or stroke. Ticagrelor (Brilinta) keeps platelets from sticking~     together and it helps people from having a heart attack. The American College of Cardiology~     has recommended a combination of aspirin and Brilinta as one of the best treatments for the~     prevention of heart attacks, and death in patients who have had a heart attack or coronary~     stents. However, it is unknown if Brilinta may improve its work to keep platelets from~     sticking together giving a loading dose in patients already treated with Brilinta. A loading~     dose is a one-time increased dose of the same drug. The purpose of this study is to~     demonstrate whether the platelets of patients treated with Brilinta become less sticky when~     Brilinta is re-loaded.~   "
140290|NCT01731028|"~     The purpose of this study is to investigate the long-term treatment with Zomacton® for~     pituitary short stature in children with insufficient growth hormone production and/or short~     stature caused by Turner's syndrome.~   "
140291|NCT01731015|"~     The goal of this study is to perform a pilot study to evaluate the utilization of oxygen as~     an inhaled contrast agent to image the airway spaces in normal and diseased human lungs to~     allow an effect size estimate to power future studies.~   "
140292|NCT01731002|"~     Double-masked, randomized, multi-center, dose-response, active-controlled parallel-comparison~     of AR-13324 to latanoprost~   "
140293|NCT01730989|"~     Oestrogen hormone deficiency in menopause leads to symptoms of which hot flushes, night~     sweats, insomnia and mood changes are the most frequent and, ultimately, worsen the quality~     of life. The gradual decline of oestrogen from peri-menopause results in altered function of~     many neurotransmitters, such as dopamine, melatonin and neuropeptides including~     beta-endorphins, which modulate the function of the hypothalamus and are involved in body~     thermoregulation.~      In post-menopause, dopaminergic activity is significantly reduced and stimulus of the D2~     receptors is effective in relieving hot flushes and in reducing the accompanying~     psychological symptoms.~      The use of hormone replacement therapy, which is generally prescribed in the case of moderate~     or severe symptoms, is limited due to real contraindications or simply the woman's refusal to~     take the therapy, despite the presence of symptoms requiring its use.~      A food supplement, named Estromineral (E), based on natural ingredients such as isoflavones,~     the absorption of which is increased by the presence of Lactobacillus sporogenes, and Vitamin~     D3 and calcium, strengthening bone mineralization, has been found to be effective at reducing~     vasomotor symptoms.~      To potentiate the effect of E on the most frequent symptoms in menopause, it was considered~     rational to add the extracts of magnolia, active on psycho-affective symptoms, and chaste~     tree, acting on both hot flushes and psychological symptoms and a new food supplement was~     developed: Estromineral Serena Plus (ESP).~      Estromineral Serena Plus is an association of isoflavones with added Lactobacillus, chaste~     tree and magnolia, active on menopausal vasomotor symptoms and on psycho-affective symptoms.~   "
140294|NCT01730976|"~     We will study whether taking vitamin D improves asthma control and spirometric values in~     elderly asthmatics.~   "
140295|NCT01730963|"~     This multi-reader multi-case study was designed to evaluate the performance of SureCALL®~     Labor Monitor® (SureCALL®) directly to the standard Tocodynamometer device (TOCO).~   "
140296|NCT01730950|"~     This randomized phase II trial studies how well bevacizumab with or without radiation therapy~     works in treating patients with recurrent glioblastoma. Monoclonal antibodies, such as~     bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells~     to grow and spread. Others find tumor cells and help kill them or carry cancer-killing~     substances to them. Specialized radiation therapy that delivers a high dose of radiation~     directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is~     not yet know whether bevacizumab is more effective with or without radiation therapy in~     treating patients with recurrent glioblastoma~   "
140297|NCT01730937|"~     This randomized phase III trial studies sorafenib tosylate and stereotactic body radiation~     therapy to see how well they work compared to sorafenib tosylate alone in treating patients~     with liver cancer. Sorafenib tosylate may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth. Stereotactic body radiation therapy may be able to send~     the radiation dose directly to the tumor and cause less damage to normal tissue. Giving~     sorafenib tosylate together with stereotactic body radiation therapy may kill more tumor~     cells.~   "
140298|NCT01730924|"~     The most widely used approach for the invasive treatment of paroxysmal atrial fibrillation is~     catheter ablation, by which radiofrequency energy is used to heat the tip of an ablation~     catheter to deliver targeted burns on the inner surface of the heart. The aim of this~     approach is to cause electrical isolation of the pulmonary veins. The purpose of this study~     is to evaluate whether the information which can be derived from the latest catheter~     technologies - on the degree of contact force between the catheter and the heart - affects~     the time to perform the procedure, or the outcomes as a result of it. Patients undergoing~     pulmonary vein isolation will be randomised to having their procedure performed with the~     contact force information available to the operator, or not available. The time taken to~     achieve pulmonary vein isolation is the primary end-point of the study.~   "
140330|NCT01730508|"~     This multicenter, prospective, observational study will evaluate the use in clinical practice~     and the efficacy and safety of Pegasys (peginterferon alfa-2a) in Chinese participants with~     HBeAg negative chronic hepatitis B. Participants receiving Pegasys according to the local~     label will be followed for the duration of their treatment and for one year after cessation~     of treatment.~   "
140299|NCT01730911|"~     Intrauterine devices (IUDs) are an effective form of contraception, but only about 3.4% of~     women in the US report using them. Women must often wait for their menses to start, or for~     results of screening for sexually transmitted infections (STIs), before their doctors will~     place IUDs for them. This is not the case with other birth control methods. Researchers know~     that it is safe to start oral contraceptive pills, transdermal patches or vaginal rings on~     the same day of a doctor's visit. In the investigators clinical practice, the investigators~     often place IUDs on the same day of a woman's visit, but outcomes have not been formally~     assessed.~      Currently, there are two kinds of IUDs available in the United States: the ParaGard T380A and~     the Mirena levonorgestrel intrauterine system (LNG-IUS). The investigators want to know if~     women who have IUDs placed at any time during their menstrual cycle have different~     experiences regarding the following, compared to those who have IUDS placed during the first~     7 days of their cycle: bleeding or cramping patterns, active pelvic infections, becoming~     pregnant more often during that first cycle (window pregnancy).~      Women who come to their provider seeking an IUD for birth control will be asked to~     participate in this study. The investigators will ask them to keep track of their bleeding~     and cramping for three subsequent months to see if patterns differ according to the day in~     their menstrual cycle that the device was inserted. They will be randomly assigned either to~     record this information on paper, or to send in the information by responding to daily text~     messages.~      The investigators want to know if women who have an IUD placed at any time during the~     menstrual cycle have different outcomes compared to those who have IUDs placed during the~     first 7 days of their cycle. If the investigators have this information, the investigators~     can make recommendations to physicians, help counsel patients, and potentially expand access~     to IUDs.~   "
140300|NCT01730898|"~     This study will evaluate the absorption of lutein when consumed in different oil blends.~   "
140301|NCT01730885|"~     Due to continuing technological progress and better understanding of the needs for glucose~     monitoring, the performance requirements of blood glucose meters, primarily regarding their~     accuracy, are constantly debated and keep evolving as a consequence. Recently a discussion~     was initiated by the Food and Drug Administration (FDA) to improve the accuracy of BG meters~     in the point-of-care testing setting by asking for fulfilment of higher requirements.~   "
140302|NCT01730872|"~     The purpose of this study is to evaluate the effectiveness of the modified Conjunctival~     Allergen Challenge (CAC) and observe how the produced allergic inflammation reacts to~     treatment with a proven ocular anti-inflammatory medication,~      Prednisolone, assessed by the following measures:~      Chronic Allergic Inflammation assessed using confocal microscopy Ocular itching Conjunctival~     redness~   "
140303|NCT01730859|"~     Both taping and balance exercises have effects on dynamic balance, so this study compared~     ankle taping and balance exercise on postural stability indices in healthy women. we~     hypothesized that both balance exercise and taping would increase stability indices but the~     effects of balance exercise was more greater than taping.~   "
140304|NCT01730846|"~     The purpose of this study is to examine whether doxazosin will attenuate the ability of~     stress to precipitate smoking lapse behavior in treatment seeking daily smokers. Participants~     will participate in a smoking cessation attempt after the laboratory sessions.~   "
140305|NCT01730833|"~     This phase II trial studies how well pertuzumab, trastuzumab, and paclitaxel~     albumin-stabilized nanoparticle formulation work in treating patients with human epidermal~     growth factor receptor (HER) 2-positive stage II-IV breast cancer. Monoclonal antibodies,~     such as pertuzumab and trastuzumab, can block tumor growth in different ways. Some block the~     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or~     carry tumor-killing substances to them. Drugs used in chemotherapy, such as paclitaxel~     albumin-stabilized nanoparticle formulation, work in different ways to kill tumor cells or~     stop them from growing. Giving pertuzumab and trastuzumab together with paclitaxel~     albumin-stabilized nanoparticle formulation may be a better way to block tumor growth.~   "
140306|NCT01730820|"~     The perioperative hemodynamic management aims to ensure organ perfusion pressure and an~     oxygen arterial transport adapted to oxygen consumption. Phenylephrine is the α-adrenergic~     agonist widely used during anesthesia for arterial pressure control.~      Several questions on phenylephrine global and regional hemodynamics effects remain~     unresolved.~      The investigators assume that Phenylephrine may decrease cardiac output by increasing the~     afterload, while most likely could also make an increase or a stability of cardiac output by~     action on the venous return. The investigators propose an observational study assessing the~     influence of preload dependence, defined by the values of pulse pressure variation, on the~     effect of phenylephrine on cardiac output, measured beat by beat by esophageal Doppler.~      The aim of the investigators work is to improve the understanding of phenylephrine action, a~     daily use therapeutic action, to improve the patients care.~   "
140307|NCT01730807|"~     A study to assess the performance of a new catheter design for the treatment of Atrial~     Flutter.~   "
140308|NCT01730794|"~     The purpose of this study is to compare a specific mode of artificial ventilation (help from~     a breathing machine) with other modes. This specific mode is called Neurally Adjusted~     Ventilatory Assist (NAVA) and is different from other modes as it uses direct signals from~     the diaphragm (breathing muscle) to help patients breathe. The investigators believe that~     using these signals, NAVA can determine the exact timing for patients' spontaneous breathing~     effort and delivers the artificial breath at the same time (in synchrony) with their own~     breath. Other modes (breathing methods) may cause asynchrony between the patient and the~     ventilator while delivering artificial breaths because of the way they operate. Asyncrony~     between patient and ventilator is a risk factor for increasing the length of artificial~     ventilation and number of related complications. The investigators would like to find out if~     NAVA performs better in establishing synchrony between patient and ventilator and as a result~     decreasing time for artificial ventilation and increasing better outcomes.~   "
140331|NCT01730495|"~     The hypothesis is that a subset of patients with chronic fatigue syndrome/ myalgic~     encephalomyelitis (CFS/ME), including also patients with no clinical response after B-cell~     depletion therapy using the anti-CD20 antibody Rituximab, may benefit from tumor necrosis~     factor-alpha inhibition using Etanercept as weekly subcutaneous injections.~   "
140372|NCT01729962|"~     The primary purpose of this comparative clinical study is to collect clinical data to~     demonstrate the equivalence of the investigational device to the predicate device for~     measurements of the eye. The secondary purpose is to evaluate any adverse events that occur~     during the clinical study.~   "
140416|NCT01729390|"~     The purpose of this research is to determine whether varying the energy density and portion~     size of the main course will affect meal energy intake after consumption of a first course~     that has previously been shown to enhance satiety. It is hypothesized that increasing either~     the energy density or portion size of the main course will increase meal energy intake after~     consumption of the first course. It is also hypothesized that compared to when a first course~     is consumed, not consuming a first course will increase meal energy intake.~   "
140309|NCT01730781|"~     The aim of the present study is to assess the availability of cannabinoid receptors (CB1R) in~     the human brain. CB1R are present in everyone's brain, regardless of whether or not someone~     has used cannabis. The investigators will image brain cannabinoid receptors using Positron~     Emission Tomography (PET) imaging and the radioligand OMAR, in healthy individuals and~     several conditions including 1) cannabis use disorders, 2) psychotic disorders, 3) prodrome~     of psychotic illness and 4) individuals with a family history of alcoholism, using the PET~     imaging agent or radiotracer, [11C]OMAR. This will allow us to characterize the number and~     distribution of CB1R in these conditions. It is likely that the list of conditions will be~     expanded after the collection of pilot data and as new data on cannabinoids receptor function~     and psychiatric disorders becomes available.~      Those in the cannabis us disorder arm of the study will have a PET scan on at least three~     occasions: once while smoking as usual, once after 48-hours of abstinence from cannabis, and~     a final time after 4 weeks of abstinence. Additional scans may be conducted within the 4~     weeks and the last scan may be conducted well beyond 4 weeks. Similarly, while most~     schizophrenia patients may get scanned just once, a subgroup of patients may get scanned more~     than once. For example to tease out the effects of medications, unmedicated patients may get~     scanned while unmedicated and again after treatment with antipsychotic medications. Similarly~     prodromes may get scanned while in the prodromal stage off medications, on medications and~     after conversion to schizophrenia.~   "
140310|NCT01730768|"~     This is a study in chronic stable Schizophrenia with the purpose to answer the question of~     whether agonism of the nicotinic alpha7 receptor is capable of enhancing cognition in a well~     defined chronic stable patient population treated with antipsychotics as standard of care,~     and thus to support the future development of AQW051 for the treatment of cognitive~     impairment associated with Schizophrenia (CIAS).~   "
140311|NCT01730755|"~     Chuvash polycythemia (CP) is a rare form of congenital polycythemia caused by mutations in~     the VHL gene. Currently, there are no therapies that have proven effective for CP. Recent~     studies have demonstrated that VHL (von Hippel-Lindau tumor suppressor) regulates the~     activity of JAK2 (Janus kinase 2). In mouse models, inhibition of JAK2 reverses the CP~     phenotype. Therefore, the investigators hypothesize that JAK2 inhibition may have significant~     clinical benefits for CP patients.~   "
140312|NCT01730742|"~     The study proposes to investigate whether sleep deprivation will affect a variety of~     measures, including hormones, immune system functioning, and behaviors related to food intake~     and hunger. It is predicted that sleep deprivation will affect circulating neutrophil~     activity, and do so via affects on DNA methylation. It is also predicted that sleep~     deprivation will up-regulate ghrelin, and down-regulate circulating oxytocin. Finally, it is~     predicted that sleep deprivation will increase participants' tendencies to pick larger~     portions of food, and also increase their tendency to purchase foods that are more caloric in~     a mock supermarket scenario.~   "
140313|NCT01730729|"~     Prolactin is a hormone produced in the pituitary gland. Previous studies have revealed that~     elevated levels of the hormone prolactin might be associated with an increased risk of breast~     cancer. Cabergoline has been shown to lower prolactin levels in the blood.~      The purpose of this study is to evaluate the effectiveness of cabergoline in treating~     metastatic breast cancer disease in those who test positive for the prolactin receptor.~   "
140314|NCT01730716|"~     The study is to determine the feasibility, safety, toxicity, and maximum tolerated (safe)~     dose of human spinal derived neural stem cell transplantation for the treatment of~     Amyotrophic Lateral Sclerosis (ALS).~   "
140315|NCT01730703|"~     The purpose of this interview study is to learn why adults would join a walking program. This~     study involves interviews with persons who are 65 years of age or older. The interview takes~     approximately 25 minutes. A total of 132 people will be enrolled. This study will examine the~     utility or value of various potential features of an incentive-based walking program. These~     data will enable us to monitor and improve upon enrollment of incentive-based walking~     programs.~   "
140316|NCT01730690|"~     Major changes in the epidemiological characteristics of bacterial meningitis have been~     observed as a result of changes in behaviour, human interventions (use of antibiotics,~     prophylactic vaccinations), as well as poorly elucidated mechanisms responsible for epidemic~     outbreaks.~      The objective of this study is to identify the determinants of in-hospital mortality of~     bacterial meningitis in adults.~      Hypothesis : the standardized data collection concerning cases of bacterial meningitis in~     adults with telephone follow-up would allow analysis of the determinants of mortality and~     neurosensory sequelae, description of the psychosocial impact and proposal of new treatment~     strategies.~   "
140317|NCT01730677|"~     The investigators address the clinical efficacy of continuing lapatinib treatment combined~     with vinorelbine after the progression of both trastuzumab and lapatinib treatment compared~     with vinorelbine alone in HER2 positive metastatic breast cancer patients.~   "
140318|NCT01730664|"~     Rationale:~      Treatment of multidrug or extensively drug resistant tuberculosis (MDR/XDR-TB) is a real~     challenge as failure in response to treatment and serious side-effects are frequently~     encountered. New, more effective drugs with less side effects are therefore urgently needed~     to solve this problem. Although several new drugs against TB are in the pipeline, physicians~     currently have limited treatment options for treatment of complicated MDR/XDR-TB cases.~     Therefore, drugs developed and labeled for other infectious diseases are evaluated for TB.~      Objective:~      The main objective of this prospective clinical trial is to evaluate pharmacokinetics of a~     standard dose (2000mg) of ertapenem in TB patients. This clinical trial will provide~     important information on PK of ertapenem in TB patients for future studies. Data can be used~     for limited sampling strategies for ertapenem based on a pharmacokinetic population model~     constructed from the full PK curves of the patients.~      Study design:~      A prospective pharmacokinetic study.~      Study population: 12 TB patients.~      Intervention: Single dose of 2000mg in a 30 minutes intravenous infusion.~      Main study parameters/endpoints:~      The pharmacokinetic parameters (Vd, Cl, AUC, etc) of ertapenem are the primary endpoints of~     the study. The T>MIC and AUC0-24h/Minimal inhibitory concentration (MIC) ratio are most~     likely the best predictive parameters for efficacy of ertapenem treatment and will be~     calculated for a range of M tuberculosis isolates.~   "
140319|NCT01730651|"~     This phase II study of high dose intensity modulated radiation therapy in the cervical cancer~     with metastatic lymphadenopathies at initial diagnosis~   "
140321|NCT01730625|"~     The development of easily disseminated and efficacious treatment of psychiatric disorder is~     an important goal for translational neuroscience research. To that end, Attention Bias~     Modification Treatment (ABMT), a novel intervention targeting threat-related attention~     biases, has been shown to reduce anxiety in adults. To date, only one RCT study examined~     whether ABMT reduces clinical anxiety in children {Eldar, 2012 #32}, and no study has~     examined whether ABMT augments the efficacy of Cognitive Behavioral Treatment (CBT), the~     treatment of choice for anxiety disorders. Studying this question in youth is particularly~     important given that the onset of most anxiety disorders is during childhood, and early~     interventions may reduce long-term affliction. The current study is the first randomized~     control trial designed to examine the augmenting effects of ABMT on CBT among clinically~     anxious youth.~      The purpose of Attention Bias Modification Therapy (ABMT) is to implicitly shape~     anxiety-related biases in attention orienting. ABMT uses the dot-probe task as a therapeutic~     tool. During training, the target location is systematically manipulated to increase the~     proportion of targets appearing at the location opposite the patient's bias. For example, in~     a training protocol intended to reduce threat bias, targets would appear more frequently at~     locations of neutral than threat stimuli.~      Although CBT is an effective treatment for anxiety disorders, combining it with other~     treatment such as ABMT could result in additional treatment effects. CBT and ABMT are two~     interventions targeting different aspects of anxiety and therefore could potentially~     complement one another. While CBT modifies explicit and voluntary attention through verbal~     intervention, ABMT alters implicit and involuntary attentional biases. If ABMT augments CBT,~     the integration of the two treatments can have few significant benefits: First, it will~     combine the explicit learning of CBT with the implicit learning of ABMT and by that reduce~     the number of patients who respond poorly to CBT or do not respond at all. Second,~     computer-based training of attention may be more acceptable than traditional in-person~     therapy formats for some children and adolescents and can raise the cooperation in therapy.~     Finally, the CBT setting and the therapist presence can help to insure that ABMT is delivered~     consistently~      The current study was designed to examine the ABMT augmentation effects on CBT for children~     with anxiety disorders. This study is the first randomized control trial in clinically~     anxious youth. Participants were randomly assigned to one of three conditions: 1. Training~     condition (CBT+ABMT), 2. Placebo condition (CBT+ ABMT-Placebo) 3. Control condition (CBT~     alone). We hypothesize that participants in the training condition will show the greatest~     improvement in anxiety symptoms.~   "
140322|NCT01730612|"~     Main objective: To determine the optimal molar doses of the biospecific antibody TF2 and 68~     Ga-IMP-288 and the optimal time for pretargeting for immuno-PET in patients with breast~     carcinoma.~      Secondary objectives: To study the sensitivity of the immuno-PET, compare its performance to~     standard imaging methods, evaluate the safety of 150 MBq of 68 Ga-IMP-288; study the~     development of immunization against TF2 or complex TF2-IMP-288;~   "
140323|NCT01730599|"~     This is a longitudinal study in patients with Parkinson's Disease (PD) carriers of a genetic~     mutation - substitution of gly with ser in position 2019 (G2019S) in the leucine-rich repeat~     kinase 2 (LRRK2) gene. The purpose of this study is to explore the association between~     genetic mutations in the known genes and their influence on disease manifestation over few~     years of follow up~   "
140324|NCT01730586|"~     The goal of this clinical research study is to learn if abraxane can help to control~     colorectal and/or small bowel cancer. The safety of this drug will also be studied.~      Abraxane is designed to block cancer cells from dividing, which may cause them to die.~   "
140325|NCT01730573|"~     Primary objective of this study is to prospectively compare and evaluate efficacy as well as~     note side effects of the interscalene block and combined suprascapular and axillary nerve~     block for ambulatory arthroscopic rotator cuff repair.~   "
140326|NCT01730560|"~     Cortical Visual Field Defects (CFVD) are common after acquired brain injury. They often cause~     problems with reading and visual exploration which impact on patients' quality of life. Apart~     from the substitutive method that uses prisms directly placed on glasses, two main~     rehabilitative methods have been explored previously: one restorative and one compensatory.~     The most effective methods seem to be based on compensatory training paradigms that target~     eye movements. They rely on voluntary mass-practice that induces changes in exploratory~     saccadic behaviour, particularly into the blind hemifield. Previous studies using this method~     have shown changes in visual scanning patterns but with only a marginal profit in terms of~     functional benefit.~      In the present study, the investigators developed a new approach to the compensatory visual~     field training based solely on a bottom-up mechanism. It does not require the patients'~     ability to voluntarily maintain attention oriented to the affected field, which may be~     difficult for brain-damaged patients. As previously reported in other pathological contexts~     (e.g. use of prism adaptation or sensory stimulation in neglect patients), bypassing~     voluntary and conscious implication of the patient can produce improvements by a more~     automatic process.~      The investigators hypotheses are: 1) that a novel ramp-step search paradigm can be used by~     hemianopic patients to automatically improve targeted eye movements into their blind visual~     field; and 2) that this will lead to behavioural improvements on ecologically valid tests of~     visual search.~   "
140327|NCT01730547|"~     The aim of the study is to evaluate the safety and efficacy of autologous mesenchymal stromal~     cells as treatment for Multiple Sclerosis.~   "
140328|NCT01730534|"~     This study is being carried out to determine the effect of dapagliflozin on cardiovacular~     outcomes when added to current background therapy in patients with type 2 diabetes with~     either established cardiovacular disease or cardiovascular risk factors.~   "
140329|NCT01730521|"~     Iron metabolism may undergo changes during exercise, with reductions in classical iron status~     markers due to a variety of postulated mechanism which include hemodilution, increased iron~     loss, hemolysis and increased iron storage in muscles. Furthermore, it has been reported that~     vigorous training increases hepcidin, a central regulatory peptide in iron metabolism. This~     increase has been ascribed to the presence of subclinical inflammation. Increased hepcidin~     levels may reduce iron bioavailability and iron incorporation in erythrocytes.~      Twenty healthy men subjects will be recruited as subjects for this study. Subjects should be~     generally healthy, with no history of blood donation in the last 6 months, should weigh less~     than 85 Kg, and not take iron supplements and/or multivitamin supplements. Subjects should~     have familiarity to sports and running, but not currently (i.e. in the past 3 months)~     training for more than 1h per week on average.~      The aim of this study is to measure an iron bioavailability during a resting and an exercise~     phase lasting approx. 14 days with training sessions on alternate days. Subjects will~     participate in both restign and exercising protocols and act as their own controls during the~     study. Iron bioavailability will be measured via the incorporation of stable isotopic labels~     14 days after administration. To control for changes in blood volume during the course of the~     study, blood volume of the participating subjects will be measured before and after the~     exercise phase with the CO-rebreathing method.~      Measurement of iron bioavailability and iron incorporation in a resting and exercising phase~     will allow determine if the increased level of hepcidin seen in in exercise will induce a~     lower iron bioavailability and iron incorporation during exercise.~   "
140405|NCT01729533|"~     The (motile sperm organelle morphology examination) MSOME allows the detection of sperm~     vacuoles that seems to be related to sperm DNA damage.~      The investigators hypothesized that couples with unexplained infertility could benefit from~     the injection of spermatozoa selected under high-magnification (x6600)~   "
140332|NCT01730482|"~     This study is designed to describe the metabolism of AT1001 (migalastat HCl) and the~     contribution of metabolism and urinary excretion to its overall elimination as part of the~     continuing assessment of the safety and effectiveness of the drug.~      This is a Phase 1, single-site, open-label, single dose study of the absorption, metabolism~     and excretion of radiolabeled AT1001 in healthy male subjects between 30 and 55 years of age,~     inclusive. Six subjects will be dosed, with the goal of having at least 4 subjects complete~     the study through follow-up. All subjects will be screened within 28 days before admission to~     the Clinical Unit. Subjects will be confined to the clinical unit for 10 days after dosing~     and will return to the clinic for a follow-up visit 28 days after dosing.~      Each subject will receive a single oral dose of AT1001 as an aqueous solution containing 150~     mg [14C] AT1001 (1 μCi). Blood, duodenal bile, expired air, urine, and feces samples will be~     collected at specified time points after dosing throughout the period of confinement at the~     study site. Safety will be assessed throughout the study by monitoring clinical laboratory~     tests, ECGs, physical examinations, vital signs, and adverse events. The total duration of~     the study for each subject is approximately 8 weeks.~   "
140333|NCT01730469|"~     This study will assess the safety, tolerability, and pharmacokinetics (PK) study of a single~     dose of 150 mg AT1001 (migalastat HCl, GR181413A) administered orally to healthy subjects~     with normal renal function and to subjects with mild, moderate, and severe renal impairment.~   "
140334|NCT01730456|"~     This multicenter, open-label, single arm, long-term extension study will evaluate the safety~     and efficacy of RoActemra/Actemra (tocilizumab) in patients with early moderate to severe~     rheumatoid arthritis who completed the WA19926 core study. Patients will receive~     RoActemra/Actemra 8 mg/kg intravenously every 4 weeks for up to 104 weeks.~   "
140335|NCT01730443|"~     Blood samples will be drawn on traumatic brain injury patients who are participating in the~     ProTECT III study.~   "
140336|NCT01730430|"~     To establish a cutoff value using a ratio of CSF tau to Aβ42 (tau/Aβ42) for distinguishing~     patients wth mild to moderate Alzheimer's disease (AD) from health elderly control subjects.~     The investigators hypothesize that a cutoff can be found that has at least 80% sensitivity~     and 60% specificity.~   "
140337|NCT01730417|"~     The goal of this proposal is to produce and test high specific activity Ultratrace iobenguane~     I 123 in normal human volunteers.~   "
140338|NCT01730404|"~     Phase IIa study in COPD patients aimed to evaluate the safety, tolerability ,pharmacodynamics~     (effect on biological markers of inflammation in induced sputum and in blood, and on~     pulmonary function) and on pharmacokinetics of CHF 6001 (a PDE4 inhibitor) after 28-days of~     daily inhaled dosing.~   "
140339|NCT01730391|"~     This study aims to provide an estimate of the proportion of suspected cases of bacterial~     meningitis that are due to N. meningitidis and the serogroup responsible in The Philippines~     and Vietnam.~   "
140340|NCT01730378|"~     This study will evaluate the immunogenicity and the safety of PrepandrixTM in Korean~     subjects. A second group of subjects will receive FluarixTM vaccine as control.~   "
140341|NCT01730365|"~     Investigation of application possibilities of optical spectroscopy within the field of~     oncology. Optical spectroscopy enables the possibility to specifically differentiate between~     different (human) tissues. The hypothesis is that incorporation of this technique into~     existing medical devices (e.g. biopsy needle) would enlarge the accuracy and reliability of~     these devices. The purpose is to improve and speed up the diagnostics and therapy of the~     malignancies.~   "
140342|NCT01730352|"~     The purpose of this study is to determine whether eradication of Helicobacter pylori~     infection is effective in the improvement of platelet counts in children and adolescents with~     chronic ITP.~   "
140343|NCT01730339|"~     The study will compare how well PF-06473871 works versus placebo in reducing skin scarring~     after scar revision surgery of existing breast scars. The study will also evaluate the safety~     of PF-06473871 in healthy adult subjects.~   "
140344|NCT01730326|"~     Patients with acute migraine attack make up the majority of patients consulting the emergency~     services due to headache. The aim of treatment in the emergency service is to achieve a~     minimum level of undesirable side effects and to quickly relieve the pain which will not~     repeat after discharge from the emergency service. Ideal drug treatment contraindication~     should be at a minimum level and not trigger migraine. Paracetamol and Nonsteroidal~     anti-inflammatory drugs are often used in the treatment of migraine headache.~      Although narcotic analgesics provide effective and rapid analgesia, they have such side~     effects as hypotension, nausea and vomiting, drowsiness. In recent years, with the production~     of parenteral forms of non-steroidal anti-inflammatory painkillers, the analgesic efficacy of~     these drugs has been one of the topics of interest to researchers. Especially intravenous~     form of paracetamol is new yet compared to other Nonsteroidal anti-inflammatory drugs, and it~     is a drug with a wide safety margin and less incidence of side effects. The effectiveness of~     the Intravenous form of paracetamol and whether it can be an alternative to other analgesics~     is one of the major research topics today, and more study is needed on this subject.~      Both drugs are often used in emergency services to treat headache caused by acute migraine~     attack. Our aim is to compare the effectiveness of intravenous dexketoprofen with paracetamol~     in the treatment of the headache caused by acute migraine attack.~   "
140364|NCT01730066|"~     Surgery in the mouth and oropharynx is performed in an area colonised by bacteria~     non-pathogenic and pathogenic.~      Antibiotics are used regularly resulting in disturbances in the intestinal microbiological~     flora and consequently diarrhoea that can be troublesome. The use of antibiotics throughout~     the hospital stay for these difficult cases represent a risk of development of resistant~     strains.~      Most of the patients have cancer diagnoses and have radiation therapy before surgery. This~     increases the risk of the patients having pathogenic bacteria normally present in the lower~     GI-tract.~      The investigators have shown for ICU patients that treatment with probiotics reduces the~     number of emerging enteral bacteria in the oropharynx and now the investigators will perform~     an adjusted procedure for patients planned for large ear, nose, and throat (ENT) surgery.~      Patients will preoperatively gurgle a suspension of probiotics and then swallow the~     preparation.~      Postoperatively the probiotics is given enterally and a eventually by mouth again.~      Cultures will be taken from the oropharynx and tracheal secretions and the results will be~     compared~   "
140345|NCT01730313|"~     Nodding Syndrome (NS) is a novel form of epilepsy seen predominantly among children aged 5-15~     years and characterized by head nodding, progressively worsening seizures, and cognitive~     impairment. To date, the cause of NS remains unclear. A recent assessment by the Uganda~     Ministry of Health (MOH), World Health Organization (WHO), and US CDC conducted in Kitgum~     District in northern Uganda documented that the nodding episodes themselves resulted from~     atonic seizures, and that the children also exhibit multiple different seizure types, both~     clinically and electrographically. The investigation also found that there was significantly~     greater sero-positivity for onchocerciasis among children with NS compared with control~     children, and demonstrated low serum concentrations of vitamin B6 (pyridoxine) among both~     cases and controls. Vitamin B6 is involved in neurotransmission and has been an effective~     treatment of seizures for certain rare type of epileptic syndrome. Children with nodding~     syndrome in Kitgum have been episodically treated with multivitamins, ivermectin, and~     anti-epileptic medications including phenobarbital, phenytoin, carbamazepine, and valproate,~     but the possible beneficial or harmful effects of any of these medications for nodding~     syndrome has not been systematically assessed, and reports from parents and guardians about~     apparent effectiveness are varied.~      The investigators propose a randomized blinded four group clinical trial with crossover~     design to study the effect and response to therapeutic doses of oral pyridoxine (vitamin B6)~     and treatment with currently used conventional anti-epileptics including phenytoin and sodium~     valproate, among children with nodding syndrome.~   "
140346|NCT01730300|"~     The main purpose of the study was to evaluate the efficacy of Levonorgestrel Releasing~     Intrauterine devices (LNR-IUD) on genitourinary symptoms in patients with abnormal uterine~     bleeding. The patients were asked urogenital distress inventory (UDI) (which includes;~     irritative symptoms, stress symptoms, obstructive discomfort) and incontinence impact~     questionnaire (IIQ) (which includes; physical activity, travel, social/relationships,~     emotional health)questionnaires in the day of application LNR-IUD and six months later this~     procedure. Statistical analyse will be performed to evaluate the changes in this time period.~   "
140347|NCT01730287|"~     Deep carious lesions will encounter the dentist with the challenge of selecting a treatment~     method that could avoid the pulpal exposure and maintain the pulp vitality.Conventional~     restorative treatments suggest complete removal of the caries in one visit which could cause~     pulpal exposure in 53% of the cases which in next step needs pulpotomy, pulpectomy or Root~     Canal Therapy (RCT).~      Stepwise Excavation(SE)is an old concept but has been researched recently to reduce the~     possibility pulpal exposure during the removal of the lesion. Contrary to Indirect Pulp~     Capping (IPC), in this technique only the central infected part of the caries is removed in~     first visit and the rest of the caries will be lined by a suitable material to suppress the~     remained cariogenic biomass and seal the cavity. This will help the pulp to defend and~     survive. After a period, the cavity is re-opened and the rest of the caries which is darker,~     harder and with less bacteria will be removed and the tooth is restored permanently.The aim~     of this study was to compare the effect of different lining materials in clinical and~     radiographical symptoms in stepwise excavation without re-enter after one year.~   "
140348|NCT01730274|"~     Aim: To investigate the effect of cerebellar tumor surgery on the resting state functional~     connectivity level in higher order cognition networks known to interact with the cerebellum.~     Furthermore, to correlate the connectivity level of these networks with the~     neuropsychological performance and functional outcome of the patients.~      The investigator's hypothesis is that the functional connectivity of various cognition~     networks in the cerebrum as assessed by resting-state functional magnetic resonance imaging~     can be impaired after cerebellar tumor surgery and can be correlated with the~     neuropsychological performance. The effect of surgery on the cognition networks and the~     neuropsychological performance is dependent on the tumor location within the cerebellum. Such~     a correlation seems feasible as functional connectivity analysis could be correlated with the~     neuropsychological impairment in various neuropsychiatric disorders. Furthermore,~     investigators were able to depict the maturation of the functional connectivity networks in~     parallel to the neurocognitive development in childhood~   "
140349|NCT01730261|"~     This study will examine the feasibility of online delivery of emotional regulation training~     to individuals with TBI with emotional dysregulation. 80 subjects with significant emotional~     dysregulation will be enrolled and will receive 24 60-minute emotional regulation sessions~     twice a week for 12 weeks, delivered online in group modality. Attendance and compliance will~     be tracked, and outcomes will be monitored using online data collection methods. Treatment~     satisfaction and participant subjective experience will also be assessed.~   "
140350|NCT01730248|"~     The purpose of this phase Ib clinical trial is to evaluate the safety of the combination of~     INC424 and BKM120 in the myelofibrosis population and to establish the maximum tolerated dose~     and or the Recommended Phase II dose of the combination guided by the Bayesian dose~     escalation model. INC424 has shown efficacy in myelofibrosis (MF) and is approved in the US~     and EU for the treatment of MF. BKM120 is a PI3K inhibitor. Preclinical and early clinical~     experience support inhibition of the PI3K/mTOR pathway in MF as aberrant activation of the~     pathway has been observed in MF models and may contribute to the pathogenesis of the disease.~   "
140365|NCT01730053|"~     To evaluate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab~     (REGN727/SAR236553) as an add-on therapy to other LMT in patients with hypercholesterolemia~     at high cardiovascular (CV) risk.~   "
140366|NCT01730040|"~     This is a randomized, double-blind, active-comparator, parallel-group study in patients at~     high cardiovascular risk with nonfamilial hypercholesterolemia or heterozygous familial~     hypercholesterolemia (heFH).~   "
140367|NCT01730027|"~     This randomised, double-blind, placebo-controlled study will evaluate the efficacy and safety~     of ADC3680 administered once daily as an add-on therapy to inhaled corticosteroids and when~     co-administered with montelukast in patients with inadequately-controlled asthma. Patients~     will be randomised to 3 Arms to receive ADC3680, placebo or montelukast.~   "
140368|NCT01730014|"~     This trial is conducted in Europe. The aim of this trial is to investigate safety,~     tolerability, pharmacokinetics (the exposure of the trial drug in the body) and~     pharmacodynamics (the effect of the investigated drug on the body) of subcutaneous~     NNC0148-0000-0287 (insulin 287) in healthy subjects and in subjects with type 1 diabetes~   "
140351|NCT01730235|"~     The last mile of the medication use system requires tools to help patients comply with~     medication administration rules and monitor for side effects. Personal health records (PHR)~     and emerging user-adopted communication tools promise to change the landscape of medication~     management. The overarching goal of the MyMediHealth project is to investigate ways in which~     PHRs and supported applications can improve the safety and quality of medication delivery.~     Preliminary work in this area by a team of parents, patients and school/clinic health~     providers created a vision for MyMediHealth, a next-generation medication management system.~     MyMediHealth was envisioned to allow home-based, school-based, and other caregivers to ensure~     safe and effective medication delivery. This vision featured just-in-time medication~     reminders to children with special health care needs, two-way communication to log when doses~     have been administered or when side effects have occurred, and mechanisms to warn caregivers~     about side effects and drug interactions. However, much of this work was done using~     prototypes, storyboards, and vision videos. Recognizing that this vision cannot be carried~     out without significant changes in processes and policies, the purpose of this proposed study~     is to evaluate the impact of medication management tools such as MyMediHealth on medication~     adherence for children with chronic illnesses. Specifically, the investigators hypothesize~     that compared with usual practice, children using mymedihealth will have improved medication~     adherence and will report improved (decreased) asthma symptoms.~   "
140352|NCT01730222|"~     Four-drug combo yielded a statistically significant improvement in progression-free survival~     and overall survival compared to gemcitabine in patients with advanced pancreatic~     adenocarcinoma. Nab-Paclitaxel showed promising antitumor activity in patients with~     pancreatic cancer. Given the synergism of taxanes with gemcitabine, fluoropyrimidines and~     platinating agents the role of nab-Paclitaxel in a 4-drug regimen will be explored.~      The aim of this trial is to determine the recommended dose of nab-paclitaxel in combination~     with cisplatin, capecitabine, and gemcitabine, PAXG regimen (Phase I), and to evaluate the~     feasibility and the activity of the PAXG regimen in patients with stage III and IV pancreatic~     cancer.~   "
140353|NCT01730209|"~     Tuberous sclerosis complex (TSC) is a genetic disease that leads to mental retardation in~     over 50% of patients, and to learning problems, behavioral problems, autism and epilepsy in~     up to 90% of patients. The underlying deficit of TSC, loss of inhibition of the mammalian~     target of rapamycin (mTOR) protein due to dysfunction of the tuberin/hamartin protein~     complex, can be rescued by everolimus. Everolimus has been registered as treatment for renal~     cell carcinoma and giant cell astrocytoma (SEGA). Evidence in human and animal studies~     suggests that mTOR inhibitors improve learning and development in patients with TSC.~   "
140354|NCT01730196|"~     Fit Body and Soul is single-blinded, cluster- randomized trial of a faith-based adaptation of~     the GLB program compared with a health education intervention.~   "
140355|NCT01730183|"~     This is a Phase I/II, multicenter, prospective, non-randomized, open label study to evaluate~     the safety/efficacy of autologous bone marrow-derived stem cell transplantation in spinal~     cord injury patients.~   "
140356|NCT01730170|"~     Epilepsy is one of the most common neurological disorders affecting women of childbearing~     age. Poor pregnancy outcomes are increased in these women and their children. The proposed~     studies will increase our knowledge on multiple levels to improve care and reduce adverse~     outcomes in these mothers and children. An overall goal of this study is to establish the~     relationship between antiepileptic drug exposure and outcomes in the mother and child as well~     as describe and explain the variability in antiepileptic drug exposure and response.~   "
140357|NCT01730157|"~     This pilot clinical trial studies radioembolization and ipilimumab in treating patients with~     uveal melanoma with liver metastases. Radioembolization kills tumor cells by blocking the~     blood flow to the tumor and keeping radioactive substances near the tumor. Monoclonal~     antibodies, such as ipilimumab, can block tumor growth in different ways. Some block the~     ability of tumor cells to grow and spread. Others find tumor cells and help kill them or~     carry tumor-killing substances to them. Giving radioembolization together with ipilimumab may~     kill more tumor cells in patients with uveal melanoma~   "
140358|NCT01730144|"~     Background:~      - One form of the influenza vaccine is a nasal spray. It uses a live but weakened flu virus.~     Researchers want to better under how the live vaccine interacts with the body s immune~     system. They will test the nasal spray flu vaccine (called FluMist) against a saline (salt~     water) nasal spray. They will then look at blood and nasal cell samples to see how the~     vaccine affects these cells immune response.~      Objectives:~      - To look at immune changes in nasal and blood cells in people who receive live flu vaccine.~      Eligibility:~      - Healthy volunteers between 18 and 49 years of age.~      Design:~        -  Participants will have five outpatient visits for this study. Each visit will last up to~          2 hours.~        -  At the first visit, participants will have a physical exam and medical history. They~          will give blood and urine samples. Nasal cell samples will also be collected.~        -  A week later, participants will have either the nasal spray flu vaccine or a saline~          spray. They will know which spray they will receive. Blood samples will be collected.~        -  Two days after the vaccination, they will have another physical exam. Blood and nasal~          cell samples will be collected.~        -  At the final two visits (1 week and 1 month after the vaccination), more blood samples~          will be collected.~        -  Those who had the saline spray will be able to have the actual vaccine spray at the last~          study visit.~        -  The ratio of participants who receive vaccine to those who receive saline will be 4:1.~   "
140369|NCT01730001|"~     This study looks at advanced airway management in critically ill or injured patients treated~     by physician manned emergency medical services, comparing early (on-scene) intubation to late~     (emergency department) intubation.~   "
140370|NCT01729988|"~     This is a pilot study to assess the effectiveness, safety and feasibility of carotid body~     removal in patients with high blood pressure (hypertension) resistant to medical treatment.~     Patients with high blood pressure are at significant risk of medical complications including~     stroke and heart disease. The principle research question is whether removal of the carotid~     body will lead to an improvement in the blood pressure of this patient group.~   "
140371|NCT01729975|"~     The primary objective of this clinical study is to collect clinical data to support an FDA~     510(k) submission for the Nidek Specular Microscope CEM-530. The secondary objective is to~     evaluate any adverse events found during the clinical study.~   "
140359|NCT01730131|"~     Background:~      - Progressive multifocal leukoencephalopathy (PML) is a severe viral infection of the brain.~     It is caused by JC virus. Many people have this virus in their bodies all their life, but it~     is usually kept in check by their immune system. If the immune system does not work right~     because of a disease or medication, the virus becomes active and can damage cells in the~     brain. Not much is known about PML or how it affects the immune system. Researchers want to~     study people with PML to better understand the natural history of the disease.~      Objectives:~      - To study the natural history of PML.~      Eligibility:~      - Individuals at least 2 years of age who have PML.~      Design:~        -  Participants will be screened with a physical exam, medical history, and imaging~          studies.~        -  Participants will have several visits to the National Institutes of Health Clinical~          Center. There will be an initial visit, monthly visits for the next 6 months, a 12-month~          visit, and possible visits afterward.~        -  At the initial visit, participants will give blood, urine, and spinal fluid samples.~          They will also have neurological tests and imaging studies of the brain.~        -  For the next five visits, participants will give blood and urine samples. They will also~          have neurological tests and imaging studies of the brain.~        -  The 6-month and 12-month visits will repeat the tests from the initial visit.~        -  Other optional procedures include bone marrow samples and skin biopsies. Additional~          blood tests and imaging studies may be performed.~        -  Treatment will not be provided as part of this study.~   "
140360|NCT01730118|"~     Background:~      - HER2/neu (HER2) is a tumor protein that appears in almost a third of breast cancers and in~     several other types of cancers such as colon, prostate and non-small cell lung. Tumors that~     overexpress HER2 can be associated with a more aggressive cancer, higher recurrence rates,~     and reduced survival rates. Researchers are testing a therapeutic cancer vaccine designed to~     stimulate the immune system to recognize HER2. The vaccine, called AdHER2/neu dendritic cell~     vaccine, is custom-made using an individual s own immune cells. These cells will be collected~     and used to produce the vaccine.~      Objectives:~      - To test the safety and effectiveness of AdHER2 vaccination.~      Eligibility:~      - Individuals at least 18 years of age who have HER2-expressing tumors.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Imaging studies will also be performed.~        -  Participants will have an apheresis procedure to collect immune cells to create the~          vaccine.~        -  Participants will receive four doses of the vaccine at study Weeks 0, 4, 8, and 24.~        -  Participants will be monitored with physical exams, frequent blood tests and imaging~          studies.~   "
140361|NCT01730105|"~     Background:~      - Researchers are studying how metabolism and hormone levels change in response to mild~     changes in environmental temperature. Changes in metabolism may lessen with time because of~     hormonal adaptations. If this increase in metabolism continues for a longer period, mild cold~     exposure may cause weight loss. It is unclear whether exposure to a warmer temperature may~     cause opposite changes in metabolism. Researchers want to see if longer exposure (1 month) to~     different temperatures can affect how the body uses energy.~      Objectives:~      - To test changes in energy metabolism in response to different room temperatures.~      Eligibility:~      - Healthy men between 18 and 40 years of age.~      Design:~        -  The entire study will last for 4 months. It will involve a screening visit and a 4-month~          inpatient stay at the National Institutes of Health Clinical Center. The inpatient stay~          will be in a private room at the Metabolic Clinical Research unit. Study participants~          will be required to stay in the Metabolic Clinical Research unit during the night, but~          are free to leave during the day.~        -  At the screening visit, participants will have a physical exam and medical history.~          Blood samples will be collected. A heart function test and diet questionnaire will also~          be given.~        -  During the first month, the temperature of the private room will be set at to 75.2~          degrees F. This will allow the body to become used to the testing environment.~        -  During the second month, the temperature will be set to either a cool (66.2 degrees F)~          or a warm (80.6 degrees F) temperature.~        -  During the third month, the temperature will return to 75.2 degrees F.~        -  During the fourth month, the temperature will be altered to the opposite temperature to~          the one set in the second month.~        -  Throughout stay, participants will have daily temperature monitoring and will keep a~          food diary. Once a week, they will collect all of their urine for 24 hours. Once a~          month, they will spend 24 hours in a metabolic suite to study their metabolism rate.~        -  Throughout stay, the food will be provided as part of the study.~        -  During the first and third month (75.2 degrees F) the participants will be allowed to~          leave the Metabolic Clinical Research unit during the weekends, while during the second~          and forth month (66.2 or 80.6 degrees F), the participants will be allowed to spend one~          weekend out of the Metabolic Clinical Research unit.~        -  Other tests, such as body scans, fat tissue samples, and imaging studies, will be~          performed as needed.~   "
140362|NCT01730092|"~     Background:~      - High blood pressure in the lungs, known as pulmonary arterial hypertension (PAH), is a rare~     disorder. Some people have disease-associated PAH and some have PAH from an unknown cause.~     Researchers want to follow the natural history of all PAH patients to understand how PAH~     progresses in order to discover targets for future research into new treatments. To further~     identify treatment targets, they will compare healthy volunteers to patients with PAH.~      Objectives:~      - To study the natural history of PAH.~      Eligibility:~        -  Individuals at least 18 years of age who have PAH.~        -  Healthy volunteers at least 18 years of age.~      Design:~        -  Participants with PAH will have periodic visits to the National Institutes of Health~          Clinical Center. After the first visit, they will return in 6 months and then yearly or~          every other year for as long as the study continues.~        -  The first visit will take up to 3 days. It will involve the following tests:~        -  Physical exam and medical history~        -  Blood and urine samples~        -  Heart and lung function tests and imaging studies~        -  Six-minute walk test~        -  Questions about exercise and physical activity~        -  Healthy volunteers will have only one visit to the Clinical Center, during which they~          will undergo screening tests, and complete many of the same tests as patients with PAH~   "
140363|NCT01730079|"~     Background:~      - Near-infrared spectroscopy (NIRS) is a functional imaging technique that can be uses light~     to study brain function while allowing for movement. To look at blood flow in the brain, NIRS~     uses a low-power light source with detectors that see how the light changes as it passes~     through brain tissue. Brain blood flow can indicate which parts of the brain are active~     during different tasks. Researchers want to study children with attention deficit~     hyperactivity disorder (ADHD) and autism spectrum disorders (ASD) and will use NIRS to~     compare the blood flow in the brain of children with ADHD and ASD with that of typically~     developing children.~      Objectives:~        -  To see how well NIRS can detect changes in brain blood flow during tests of thinking and~          memory in children.~        -  To compare blood flow in the brains of typically developing children and those with ADHD~          or ASD.~      Eligibility:~      - Children between 4 and 8 years of age with ASD, ADHD, or children with no psychiatric~     diagnoses.~      Design:~        -  Participants will be screened for eligibility. Those who are taking stimulant medication~          for ADHD or ASD will need to stop taking it for 3 days before the study visit.~        -  After participating in a screening assessment, all participants will have one study~          visit. At this visit, they will have be asked to complete two tasks during a NIRS scan.~          For both tasks, they will react to images on a computer screen. This visit will last~          about 2 hours.~        -  This is a testing study only. No blood or other samples will be needed for this study.~   "
140373|NCT01729949|"~     1. The primary objective is to determine the effect of fruit polyphenols on postprandial~          lipoprotein triglyceride metabolism after consumption a standard high carbohydrate/fat~          breakfast meal with a beverage rich in fruit-derived polyphenols compared to energy and~          macro-/micro-nutrient matched control beverage (acute, Part 1).~        2. Secondary objectives are: 1)to assess the effects of consuming daily for 8 weeks~          (chronic, Part 2) a beverage rich in fruit polyphenols compared to an energy and~          macro-/micro- nutrient matched control beverage on fasting glucose, insulin, lipids and~          markers of oxidative stress; and 2) to assess the effects of these beverages on~          meal-related changes in metabolic and oxidative stress measures after 8 weeks daily~          consumption.~   "
140374|NCT01729936|"~     Primary care centres are a key setting to treat people with overweight and moderate obesity.~     There is growing evidence that sitting for a long time is negatively associated with people's~     health. Interventions with the aim of reducing daily time of sedentary activities can be an~     effective strategy to increase daily energy expenditure. To improve the effectiveness of~     programmes promoting physical activity in primary care we need some clear action protocols~     that can be easily integrated in the daily routines of primary care professionals.~      Objective. The objective of the study is to evaluate the effectiveness of a six-moth primary~     care intervention to reduce diary hours of sitting time in overweight and obese sedentary~     patients, as well as to increase their weekly caloric spend.~      Methods. The design of the study is a simple randomized controlled trial. Ten primary care~     centers will be invited to participate and will be randomized into control (CG) and~     intervention group (IG). Each professional will randomly invite to participate voluntarily~     moderate obese or overweight patients (BMI: 25-34,9 kg/m2) of both sexes, aged between 25 and~     65 years old, who are 6 or more than 6 hours daily sitting. A total of 400 subjects (200~     individuals in each group) are needed. In addition, 50 subjects with fibromyalgia will be~     included in the study to know the feasibility of the intervention among them.~      The main dependent variable (sitting times) will be measured with an ActivPAL during first~     and last intervention week. There will be a follow up after 3, 6 and 12 months of the end of~     the intervention. Other variables included in the study: number of steps walked, subjective~     level of physical activity, weight, height, BMI, skinfolds, waist circumference,~     triglycerides, total cholesterol, (LDL and HDL), glucose, sociodemographic variables, blood~     pressure and quality of life related to health. A descriptive analysis of all variables and a~     multivariate analysis to assess differences among intervention and control group will be~     undertaken. Multivariate analysis will be carried out to assess time changes of dependent~     variables. All the analysis will be done under the intention to treat principle.~   "
140375|NCT01729923|"~     This phase II trial studies how well capecitabine and celecoxib with or without radiation~     therapy works in treating patients with colorectal cancer that is newly diagnosed or has been~     previously treated with fluorouracil, and has spread to other parts of the body (metastatic).~     Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth~     of tumor cells, either by killing the cells or by stopping them from dividing. Celecoxib may~     stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~     Radiation therapy uses high-energy x-rays to kill tumor cells. Giving capecitabine and~     celecoxib together with radiation therapy may kill more tumor cells.~   "
140376|NCT01729910|"~     Child overweight has become one of today's most important public health concerns. Engaged and~     skilled parenting that models, values, and encourages healthy eating habits and a physically~     active lifestyle can play a key role in childhood overweight prevention and reduction.~     Primary care providers are well positioned to intervene with children and their parents, but~     face many barriers in addressing child overweight. A child overweight treatment approach is~     proposed for the primary care setting to facilitate parents' active involvement and~     self-efficacy in promoting healthy eating habits and physical activity for their children. We~     will test the following hypotheses: Hypothesis I (primary hypothesis): Children assigned to~     the intervention group will improve more in weight status (measured by BMI percentile) than~     children in the control group. Hypothesis II: Primary care providers assigned to the~     intervention group will improve more in their competence in addressing child overweight than~     the providers in the control group. Hypothesis III: After the intervention, parents in the~     intervention group will have more involvement and self-efficacy in promoting healthy weight~     for their children than parents in the control group. Hypothesis IV: Compared to the control~     group, the intervention group will improve more in family diet and eating, physical activity~     behaviors, as well as parental attitude and beliefs. Eighty children five to eleven years old~     who are overweight or obese will be recruited from two pediatric and two family practice~     clinics in southern Appalachia. Children will be randomly assigned to intervention and~     control groups based on clinic affiliation. Parents of children in the intervention group~     will participate in four clinic-based group sessions using the NIH We Can! curriculum~     moderated by a trained clinic provider, two individual brief motivational interviewing visits~     with their clinic provider, and four follow-up phone calls with the project coordinator or~     registered dietician. Parenting behaviors and attitudes, and family eating and activity~     habits, and children's weight status will be assessed at baseline, at the completion of the~     intervention, and at six months after the intervention. Changes in the assessments will be~     compared between treatment and control groups. Changes in provider and parent attitudes and~     perceptions about this treatment approach,adherence to the program, and estimates of~     associated time will be measured.~   "
140377|NCT01729897|"~     The study is designed to explore and compare the efficacy and safety of etomidate and~     propofol with or without analgesic for painless gastroscopy, and to provide more reliant~     support for implementation and promotion of comfort care.~   "
140378|NCT01729884|"~     This phase II trial studies how well vaccine therapy works in treating patients with stage IV~     hormone receptor positive breast cancer. Vaccines made from peptides may help the body build~     an effective immune response to kill tumor cells.~   "
140379|NCT01729871|"~     The purpose of this exploratory study is to evaluate the safety of rivaroxaban and~     uninterrupted vitamin K antagonist (VKA) in adult participants with non-valvular atrial~     fibrillation (NVAF) who undergo catheter ablation as measured by post-procedure major~     bleeding events.~   "
140380|NCT01729858|"~     The purpose of this research study is to identify reasons that cause an all-ceramic bridge to~     fracture which include the thickness of the bridge material, the type of bridge material and~     the bite force of the person. This all-ceramic bridge will be compared to a metal-ceramic~     bridge. The investigators are conducting this study so we can make bridges which can~     withstand forces in the mouth which tend to break them.~      The overall objective of this research is to analyze how properties of ceramic materials and~     different forces in the mouth interact with each other to affect the longevity of these~     bridges. These include fracture toughness, elastic modulus of ceramic layers and supporting~     substrate, core thickness, connector height, wear, loading orientation, and maximum clenching~     force.~   "
140381|NCT01729845|"~     This phase I/II trial studies the side effects and best dose of decitabine followed by~     mitoxantrone hydrochloride, etoposide, and cytarabine and to see how well they work in~     treating patients with acute myeloid leukemia or high-risk myelodysplastic syndrome that has~     returned after a period of improvement or does not respond to treatment. Drugs used in~     chemotherapy, such as mitoxantrone hydrochloride, etoposide, cytarabine, and decitabine, work~     in different ways to stop the growth of cancer cells, either by killing the cells, by~     stopping them from dividing, or by stopping them from spreading. Giving more than one drug~     (combination chemotherapy) may kill more cancer cells.~   "
140415|NCT01729403|"~     This single-center, randomized, double-blind, placebo-controlled study will evaluate the~     effect of aleglitazar on insulin sensitivity in patients with type 2 diabetes mellitus who~     are inadequately controlled on metformin monotherapy. Patients will be randomized to receive~     either aleglitazar 150 mcg or placebo orally daily for 16 weeks, in addition to their~     existing dose and regimen of metformin.~   "
140382|NCT01729832|"~     Many hospitals, including the Ohio State University Medical Center, will take pictures of the~     blood vessels in a patient's abdomen before they decide to perform a breast reconstruction~     using the patient's own tissue. These pictures are called computed tomography (CT) angiograms~     and are like a map of each patient's anatomy. However, no study has been reported that~     determined how accurate these pictures are at showing the surgeon where all of the blood~     vessels were located. This study will try to determine if these pictures are missing any~     blood vessels that are found during surgery and if the pictures show the correct location of~     the vessels~   "
140383|NCT01729819|"~     The purpose of the study is to investigate the efficacy of combining tolterodine and~     desmopressin compared with tolterodine monotherapy in the treatment of women with overactive~     bladder with nocturia in terms of reduction of nocturnal voids during 3 months of treatment~   "
140384|NCT01729806|"~     This partially randomized phase I trial studies the side effects and best dose of ipilimumab~     when given together with rituximab in treating patients with B-cell lymphoma that has~     returned or has not responded to treatment. Monoclonal antibodies, such as ipilimumab and~     rituximab, may interfere with the ability of cancer cells to grow and spread.~   "
140385|NCT01729793|"~     The primary objective of the study is to assess the efficacy of Digestive Enzyme Blend #2, a~     digestive enzyme dietary supplement product, on markers indicative of inflammation after a~     meal. The markers will be assessed by blood levels tumor necrosis factor alpha (TNF-alpha),~     interleukin-1 beta (IL-1beta), interleukin-6 (IL-6), and high sensitivity C-reactive protein~     (hsCRP) at times 0, 45 minutes, 2 hours and 4 hours post-meal. A full complete blood count~     (CBC)and an erythrocyte sedimentation rate (ESR) blood test will also be conducted at times 0~     and 4 hours post-meal. In addition, a questionaire on Gastrointestinal symptoms will be~     administered 4 hours post-meal. The study hypothesis is that some or all of these potential~     markers of inflammation will increase following the meal, and the amount of increase in~     inflammation will be attenuated when a digestive enzyme is consumed with the meal compared to~     the placebo. In addition, it is hypothesized that levels of gastric discomfort as assessed by~     the questionaire will be reduced with the digestive enzyme compared to the placebo.~   "
140386|NCT01729780|"~     12% of patients suffering from an acute crornary syndrome will develop long lasting anxiety~     symptoms. The object of this study is to lessen or prevent these symptoms by the use of~     neurofeed back (EEG-NF).~   "
140387|NCT01729767|"~     Meniere's disease is a chronic illness that affects a substantial number of patients every~     year worldwide. The disease is characterized by intermittent episodes of vertigo lasting from~     minutes to hours, with fluctuating sensorineural hearing loss, tinnitus, and aural pressure.~     It has recently been suggested that viral etiologies specially Herpes virus might be the~     underlying reason. The investigators study is a randomized, double- blinded~     placebo-controlled clinical trial in Amiralam Hospital. In this study the primary objective~     is to assess efficacy of Acyclovir in control of symptoms in patients with Meniere's disease~     specially their vertigo attacks. Inclusion criteria would be patient's willingness to~     participate in the study and follow ups, being 18 years old or older, having at least 2~     vertigos per month each at least 20 min, interfering with function, and not on medication for~     Meniere's disease for at least 3 months before the trial. They should not have any history of~     allergy to Acyclovir, renal insufficiency or Creatinine above 1.5 mg/dl, hepatic enzymes more~     than three times normal, serious uncontrolled illness, be pregnant or nursing or have~     previous surgeries on Endolymphatic Sac. Participants will be randomly placed in 2 different~     arms getting either Acyclovir 400 mg or placebo (inert ingredient). They will take the~     medication for 10 days 5 times a day, then 3 times a day for next 10 days, and 2 times a day~     for the last 10 days. Patients will report changes in their symptoms 10 days after initiating~     the drug and in 1, 3, 6 month intervals.~   "
140388|NCT01729754|"~     This study is being conducted to evaluate the efficacy and safety/tolerability of~     tildrakizumab (SCH 900222/MK-3222) in a population of participants with moderate-to-severe~     plaque psoriasis.~   "
140389|NCT01729741|"~     Thyroidectomy is one of the most commonly performed operations in general surgery. Available~     data seem to suggest an association between no-drain usage and a shorter duration of hospital~     stay. Seung et al found that the (following thyroidectomy) time to discharge after~     thyroidectomy was significantly shorter in the no drain group compared to the drain group.~     Similar results were recorded in a study conducted by Davari et al. Hyoung et al reported the~     incidence of hematoma formation post- thyroidectomy to be varying between 0.3%-4.3%. Tahsin~     et al reported that post-thyroidectomy bleeding is as rare as 0.3%-1.0%. The fear of an~     hematoma enlarging and obstructing the airway and causing difficulty in breathing, prompts~     many surgeons to use drains routinely after any type of thyroid surgery. The main reason is~     to drain off a possible postoperative hemorrhage, which may compress the airway and produce~     respiratory fail~   "
140390|NCT01729728|"~     To find out if a drug called tapentadol administered by mouth safely relieves pain in~     children. Look at the amount of tapentadol in the blood after a single oral dose.~      Tapentadol oral solution for children is still being tested and is not yet registered.~     Tapentadol tablets are effective in treating both acute and chronic pain in adults. This~     trial will help to understand how tapentadol oral solution works in children.~   "
140391|NCT01729715|"~     The investigators are conducting a randomized trial of behavioral treatments for young~     children with insomnia. The investigators are comparing the improvement in sleep patterns~     after families are given access to Internet sleep instructions compared to DVD sleep~     instructions.~   "
140392|NCT01729702|"~     The primary purpose of this study is to demonstrate that changes in plasma levels of~     circulating neurohormones (mainly BNP and NT-proBNP), measured at rest and post-exercise~     correlate with exercise functional limitation (assessed by exercise peak VO2) and exercise~     ultrasonic parameters (as left ventricular filling, obstruction, and mitral regurgitation)~   "
140393|NCT01729689|"~     This pilot clinical trial studies cognitive behavioral therapy in treating anxiety in~     patients with stage IV non-small cell lung cancer and their caregivers. Cognitive behavioral~     therapy may reduce anxiety and improve the well-being and quality of life of patients who~     have stage IV non-small cell lung cancer and their caregivers.~   "
140394|NCT01729676|"~     French epidemiological data have shown a heterogeneous distribution of the risk of mortality~     from prostate cancer according to region. The main objective is to describe the distribution~     of prostate cancer stages when first line hormonal therapy is introduced (overall and by~     region).~   "
140395|NCT01729663|"~     Randomized, open, Phase II-III study, comparative between treatment with CSF-470 vaccine ,~     allogeneic, irradiated with BCG and molgramostin (rHuGM-CSF) as adjuvants and interferon alfa~     2b (IFN-alpha2b) treatment , in stages IIB, IIC o III (AJCC) post-surgery cutaneous melanoma~     patients. This study has been approved by ANMAT ( Administración Nacional de Medicamentos,~     Alimentos y Tecnología Médica (ANMAT)), number 1556/2011 (www.anmat.gov.ar).~      The study Institution is Instituto Médico Especializado Alexander Fleming, Ciudad Autónoma de~     Buenos Aires, Argentina. The Sponsor is Laboratory Pablo Cassará (LPC, S.R.L.).~      Study population include a total of 108 patients (72 patients will receive CSF470 vaccine and~     36 patients will receive alpha IFN-alpha 2b) for a total of 24 months.~      CSF-470 treatment will consist of four vaccine doses id injection (three weeks apart), then~     one dose every two months for the first year and them every three months for the second year.~      Each vaccine consist of a mixture of 17,6.106 melanoma cells, from four melanoma cell lines,~     not genetically modified and lethally irradiated. As adjuvant BCG (120 µg prot) the first day~     and rHuGM-CSF (Molgramostim, 400 µg, fractionated in four days doses) will be used.~      IFN-alpha 2b treatment will consist of s.c. injection of 10 million units (MU) (5 t/w ) for~     four weeks and then 5 MU (3t/w) for 23 months.~      Both treatments will also compare quality of life (QOL) and study a possible correlation in~     the CSF470 vaccine arm between the induced immune response and clinical outcome~   "
140396|NCT01729650|"~     The aim is to evaluate the effectiveness of an intervention based on a program of physical~     activity and diet coordinated between primary care teams (PCT) and Mental Health Centres~     (MHC) to modify the weekly physical activity (PA) amount, body mass index (BMI) and waist~     circumference in patients with severe mental disorder diagnoses. To assess changes in~     cardiovascular risk, quality of life and lifestyles, secondarily. Methods: A randomized~     clinical trial with a control group, of one year of follow-up, carried out in four MHC~     Barcelona and Santa Coloma, and PCT of reference. The investigators studied patients aged 18~     - 65 years old, diagnosed with schizophrenia, schizoaffective or bipolar disorder, with~     antipsychotic medication and a low level of PA. 240 patients will be selected in each group~     (difference to be detected in the BMI:> 1.89 kg/m2; common SD: 6.2, 30% loss). Intervention:~     group educational PA program (basically walking) of 24 sessions over 12 weeks, and diet (8~     sessions in the first 8 weeks) by nurses and specialists in PA. Key measurements: level of PA~     (IPAQ questionnaire), physical examinations: BMI, waist circumference, blood pressure,~     cardiovascular risk, quality of life (SF-36), smoking habits, dietary habits (PREDIMED~     questionnaire), analytical parameters: cholesterol , triglycerides, blood glucose.~     Evaluations will be masked and conducted at 0, 3, 6 and 12 months. Analysis of variance for~     repeated measures to adjust for differences attributable to the effect of the intervention~     for potential confounders: pharmacological treatment, care level of intervention and mental~     state.~   "
140397|NCT01729637|"~     In order to minimize mechanical stress the investigators propose to implement EVLP procedure~     with a ventilation monitoring guided by the analysis of the Paw-t shape.~   "
140398|NCT01729624|"~     A qualitative study using interviews with patients who have antineutrophil cytoplasm antibody~     (ANCA) associated vasculitis, to develop a patient reported outcome (PRO)measure~   "
140399|NCT01729611|"~     Pulmonary arterial hypertension (PAH) is a condition characterized by an increased pulmonary~     vascular resistance that can lead to right heart failure and death. Several diseases are~     known etiologies of PAH including scleroderma and cirrhosis. The presence of PAH in the~     context of systemic sclerosis or cirrhosis has a dramatic impact on prognosis and survival of~     the connective tissue or liver disease.~      Despite advances in the diagnosis of PAH, echocardiography remains a necessary test for~     screening PAH in patients with scleroderma or cirrhosis. However, echocardiography is less~     than ideal for diagnosing PAH and predicting treatment response. Thus, there is a pressing~     need to identify methodologies that can accurately and non-invasively recognize the presence~     of PAH in patients with scleroderma and cirrhosis.~      Hypothesis:~        1. To measure endothelial function and exhaled gases in patients with scleroderma and~          cirrhosis. To assess whether they correlate with the presence or the development of PAH.~        2. The degree of local (forearm) capillary vasodilation during treprostinil iontophoresis~          identifies patients who will develop PAH and in those already diagnosed PAH predicts~          response to PAH-specific therapies.~   "
140400|NCT01729598|"~     The purpose of this study is to evaluate the safety of administration and effects of valproic~     acid on clusterin expression in cognitively-intact, healthy, elderly subjects. Clusterin~     mutations have recently been identified as a risk factor for the development of Alzheimer's~     Disease and changes in clusterin expression are seen in the elderly who develop Alzheimer's~     disease irrespective of whether they carry these genetic mutations or not. Valproic acid may~     prevent or reverse these changes.~      Fourteen subjects with normal memory and thinking will participate in this study. Ten of~     these subjects will receive valproic acid and 4 will receive a placebo capsule with no~     active medicine. Participants will take study medication or placebo for 28 days and be~     followed for a total 35 days in this trial.~   "
140401|NCT01729585|"~     The purpose of this study is to describe the effects of massage therapy on quality of life~     (QOL) in youth and young adults (ages 8 to 21 years) with cystic fibrosis (CF).~   "
140402|NCT01729572|"~     Schizophrenia is a chronic debilitating mental disorder, characterised by a relapsing~     remitting course. Although anti-psychotics can prevent relapse, its effect on schizophrenia~     outcome remains very limited, mainly due to very poor adherence to medications by the~     patients. This study aims to find, whether the add-on of remote monitoring of medication~     compliance via tele-medicine, to routine out-patient clinic care, can improve patients~     adherence and reduce the risk of relapse.~   "
140403|NCT01729559|"~     The rate of venous thromboembolic events in trauma patients at high risk for deep vein~     thrombosis and pulmonary embolism receiving low dose unfractionated heparin every 8 hours~     will be equivalent or less than a similar group of patients given a standard every 12 hour~     dose of low molecular weight heparin.~   "
140404|NCT01729546|"~     In this clinical trial an evaluation of a blood glucose monitoring system (BGStar) and~     several POCT (point-of-care testing) devices against two laboratory methods will be~     performed. This evaluation will be performed according to ISO (International Organization for~     Standardization) 15197 System Accuracy.~   "
140406|NCT01729520|"~     Background:~      In the early phase after a total knee arthroplasty (TKA), patients experience multi-level~     weakness in the operated leg, which is caused primarily by reduced central nervous system~     (CNS) activation failure of the muscles - especially the knee extensors. This considerable~     loss of muscle strength relates to reduced functional performance. Early-commenced,~     progressive strength training of the knee extensors of the operated leg therefore seems~     rational. However, the concern is that this type of early-commenced, intense physical~     rehabilitation exacerbates post-operative symptoms, such as knee joint pain.~      The investigators have recently reported that early-commenced physical rehabilitation,~     including progressive strength training of the knee extensors of the operated leg seems~     feasible after TKA. The classic exercise-physiology literature emphasizes loading and~     repetitions performed to contraction failure - among others - as important variables for~     muscle hypertrophy and strength gains. It is currently not known how loading and repetitions~     performed to contraction failure during knee extensions with the operated leg, influences~     post-operative knee joint pain in patients with TKA.~      Purpose and hypothesis:~      The purpose of this study is to investigate how loading and repetitions to contraction~     failure influence knee joint pain during knee extensions with the operated leg early after~     TKA.~      The hypothesis is that knee pain increases with increasing loading and fatigue.~      Methods:~      Fifteen patients with a unilateral TKA, operated between 1 to 2 weeks prior to the first~     investigation, will be included. The participants are investigated twice. During the first~     investigation, the absolute load (kilograms) corresponding to 10 Repetition Maximum (RM) (a~     load that can be lifted exactly 10 times) will be determined for unilateral (operated leg)~     knee extension. At the second investigation, at least 72 hours later, the patients will~     perform 1 set of 4 repetitions with a relative loading of 8, 14, and 20 RM each, in a~     randomized order, estimated from their 10 RM test at the first investigation. Time under~     tension (contraction velocity) and range of knee joint motion for each repetition will be~     controlled for. During the concentric phase of each repetition, the patients rate their knee~     joint pain verbally, using a numerical rating scale placed 1 meter in front of them. After a~     short break, the patients perform 1 set of knee extension with a relative loading of 10 RM~     until of contraction failure. As for the loading effect described above, they rate their knee~     joint pain during the concentric phase of each repetition.~   "
140407|NCT01729507|"~     As an add-on treatment to behavioural therapy for tobacco dependence, anodal transcranial~     direct current stimulation (tDCS) significantly increases the cessation rate compared to~     treatment with sham tDCS; endpoint analysis will be performed 1, 3, 6 and 12 months after~     completion of the smoke-free programme in combination with tDCS.~      Craving, assessed with a visual analog scale (VAS), is reduced significantly in the verum~     treatment group compared to the sham tDCS group.~      tDCS is suitable for use in larger groups (8-12 people).~   "
140408|NCT01729494|"~     The study purpose is to determine the safety and efficacy of a belatacept-based~     immunosuppressive regimen (calcineurin inhibitor free) with alemtuzumab or rabbit~     antithymocyte globulin induction and early glucocorticoid withdrawal (CSWD) and a~     belatacept-based immunosuppressive regimen with tacrolimus-based regimen with rabbit~     antithymocyte globulin induction and early glucocorticoid withdrawal in renal transplant~     recipients.~      The hypothesis is that a belatacept-based immunosuppressive regimen with alemtuzumab~     induction, mycophenolate mofetil (MMF)/mycophenolic acid (MPA), and early glucocorticoid~     withdrawal (Group A) in renal transplant recipients or Belatacept-based immunosuppressive~     regimen with rabbit antithymocyte globulin induction, MMF/MPA and early glucocorticoid~     withdrawal (Group B) will lead to less risk of graft loss, patient death, or reduced renal~     function at 12 months as compared to a tacrolimus-based immunosuppressive regimen with rabbit~     antithymocyte globulin, MMF/MPA, and early glucocorticoid withdrawal in renal transplant~     recipients (Group C).~   "
140409|NCT01729481|"~     In the current study it is examined whether patients with good risk factors (age <75 years,~     total serum bilirubin < 1,5xULN, no history of cardiovascular diseases) treated with~     gemcitabine and erlotinib who developed skin rash of any grade during the first 4 weeks of~     treatment have a comparable outcome as patients who receive FOLFIRINOX.~   "
140410|NCT01729468|"~     The objective of this study is to test the efficacy of low-dose aspirin (160 mg/day), given~     bedtime and started early during pregnancy (≤ 15 +6 weeks of gestation) in nulliparous~     pregnant women selected as high-risk by the presence of a bilateral uterine artery notch~     and/or bilateral uterine artery PI ≥ 1.7 during the first trimester ultrasound scan (11-13+6~     weeks), to prevent the occurrence of pre-eclampsia or small for gestational age at birth.~   "
140411|NCT01729455|"~     The purpose of this registry is to collect additional information regarding the side effects~     and effectiveness of BENLYSTA (belimumab) when given with other lupus medicines to adults~     with active systemic lupus erythematosus (SLE). Information will be collected on serious~     events that are not that common or may only be seen with long-term treatment. These events~     include death, cancers, serious infections and other infections of interest, and serious~     mental health problems. Information on the effectiveness of BENLYSTA will also be collected.~   "
140412|NCT01729442|"~     Transrectal High-intensity Focused Ultrasound (HIFU) is a minimally-invasive therapy for~     prostate cancer that is currently assessed in two indications: as a first-line treatment~     (either total or focal) for patients who are not eligible for surgery and as a salvage~     treatment of local recurrences after radiotherapy.~      It has recently been shown that Contrast-Enhanced Ultrasound (CEUS) can accurately assess the~     position and volume of tissue destruction at the end of prostate HIFU ablation. This can~     provide live feedback regarding the amount of residual non ablated tissue after HIFU~     treatment, which could allow immediate re-treatment in case of unsatisfactory result.~      CEUS requires the injection of micro-bubbles of sulphur hexafluoride (Sonovue, Bracco, Milan,~     Italy) which can, at least in theory, interfere with HIFU treatment. Therefore, it is~     necessary to wait 20 to 30 minutes before re-treating the patient.~      Shear-wave ultrasound elastography (SWUE, Supersonic Imagine, Aix-en-Provence, France) can~     quantify tissue stiffness. Moreover, post-HIFU necrosis is known to be stiffer than~     undestroyed prostate tissue. Therefore, SWUE could be an alternative to CEUS, and the purpose~     of this study is to evaluate the accuracy of SWUE in depicting the position and volume of~     therapeutic necrosis after prostate cancer High-Intensity Focused Ultrasound (HIFU) ablation.~      The present study is an exploratory, monocentric, prospective, descriptive study. Three~     groups of 10 patients with prostate cancer will be evaluated: patients referred for~     first-line prostate HIFU ablation, patients referred for first-line HIFU hemi-ablation (focal~     treatment) and patients referred for salvage HIFU after radiotherapy.~      SWUE will be obtained the day before HIFU ablation (D-1), immediately after HIFU ablation~     (D0) and the following day (D+1). CEUS will be performed immediately after HIFU ablation and~     D0 SWUE.~      The primary endpoint is the comparison of the thickness of undestroyed parenchyma measured by~     SWUE and CEUS.~      The secondary endpoints are:~        -  The evolution of shear elasticity within the treated area measured by SWUE at D-1, D0~          and D+1,~        -  Adverse events related to SWUE.~      The study will last 40 months.~   "
140413|NCT01729429|"~     This randomized controlled trial is designed to evaluate whether a behavioral intervention~     that includes three components: 1) reminder letters and education materials delivered before~     the clinic visit, 2) telephone recalls after the visit for those who originally decline the~     vaccine, and 3) telephone reminders for those who miss the 2nd and/or 3rd doses, increases 1~     and 3 dose coverage of the human papillomavirus (HPV) vaccine series among adolescent girls~     attending four Parkland primary care clinics in Dallas county.~      Hypothesis 1: Investigators expect higher 1 dose HPV vaccine coverage among patients in the~     Intervention group than those in the General Adolescent Vaccine Brochure group.~      Hypothesis 2: Investigators expect significantly higher 1 dose HPV vaccine coverage among~     patients in the Intervention group who initially declined the vaccine than those in the~     General Adolescent Vaccine Brochure group who initially declined.~      Hypothesis 3: Investigators expect significantly higher 3 dose HPV vaccine coverage among the~     Intervention group than those in the General Adolescent Vaccine Brochure group.~   "
140414|NCT01729416|"~     The purpose of this study is to determine if screening colonoscopy performed on adults with~     the water exchange method, as opposed to the air method, will have a higher adenoma detection~     rate.~   "
140417|NCT01729377|"~     The purpose of the proposed study is to examine the phenomenon of suicidality in old age and~     its unique characteristics. This will be performed through observing the multigenerational~     aging family from the life-course perspective, which enables the researchers to address life~     transitions, including crises leading to suicidal tendencies.~   "
140418|NCT01729364|"~     Comparing the effects of crystalloid versus colloid fluid resuscitation in CABG patients~     postoperatively regarding renal blood flow, glomerular filtration rate and renal oxygen~     demand.~   "
140419|NCT01729351|"~     To evaluate the comparative effectiveness of extrafine hydrofluoroalkane beclometasone (EF~     HFA-BDP) and other inhaled corticosteroid (ICS) therapy commonly used in the UK, specifically~     fluticasone (FP) and non-extrafine (NEF) BDP (CFC-BDP and NEF HFA-BDP) in a UK primary care~     asthma population of current smokers.~   "
140420|NCT01729338|"~     The primary purpose of this study is to estimate the overall response rate (ORR), defined as~     partial response (PR) or better at any time during induction therapy. The success of the~     therapy will be determined by ORR with strong consideration given to the secondary endpoints~     of tolerability, duration of response, and quality of life (QOL).~      All patients will be treated with the same experimental regimen. Several novel features are~     being explored: the substitution of cyclophosphamide for melphalan; once weekly AND~     subcutaneous bortezomib instead of standard twice weekly, intravenous dosing; and alternating~     bortezomib and lenalidomide in maintenance.~      The investigators hypothesize that this regimen will prove to be tolerable and effective in~     inducing and maintaining remission in a patient population that is historically very~     difficult to treat, namely Multiple Myeloma (MM) patients who are too elderly or suffer~     comorbidities, such as renal insufficiency, that otherwise complicate aggressive therapies~     like autologous stem-cell transplantation (ASCT). In short, the investigators view this as~     the Multiple Myeloma trial for non-trial candidates.~   "
140421|NCT01729325|"~     Soldiers in conflict or former conflict regions deployed in peace-keeping missions were and~     are often exposed to multiple traumatic events and situations in which they are forced to~     engage in violent behavior. The Preventive Narrative Exposure Therapy (Pre-NET) aims to~     reinforce resilience thereby reducing the risk of developing or aggravating PTSD or other~     mental disorders as a result of traumatic experiences. The effective prevention of mental~     disorders as a result of war deployment is expected to facilitate reintegration in civil life~     after deployment and reduce uncontrolled violence.~   "
140422|NCT01729312|"~     To make reading this consent form easier, the word participant refers to you or your child~     (if a minor) throughout the consent form. This research is being done to study the effects of~     an eighteen-session strengthening program and to see if there is a relationship between the~     female athletes improving their landing techniques which has been proven to decrease anterior~     cruciate ligament injuries.~      Participants have been asked to take part in a research study because you are a female~     athlete involved in a sport that has an increased anterior cruciate ligament injury rate. The~     purpose of this research study is to find out if an eighteen-session strengthening program~     will decrease your anterior cruciate ligament injury rate.~      There will be approximately ninety-four (94) people in this research study at Henry Ford~     Health System (HFHS).~   "
140423|NCT01729299|"~     To determine the role of nutrient status on ghrelin regulation of insulin secretion. We~     hypothesize that ghrelin and glucagon-like peptide-1 (GLP-1)(both are hormones made in the~     gut,) have differential effects on β-cell function in the fed state. We will compare insulin~     secretion and glucose turnover during meal ingestion using a dual glucose tracer and mixed~     meal protocol in subjects receiving ghrelin or saline. We will also determine the role of~     ghrelin-stimulated GLP-1 levels in this process using the GLP-1 receptor (GLP-1R) antagonist~     Exendin(9-39) (Ex-9).~   "
140424|NCT01729286|"~     The objective of this study is to compare the effectiveness of PriMatrix Moist Wound Therapy~     (MWT) with Standard of Care MWT for the treatment of chronic diabetic foot ulcers in subjects~     with diabetes mellitus and without significantly compromised arterial circulation.~   "
140425|NCT01729273|"~     The purpose of this study is to assess exercise performance in 20 healthy children 10-19~     years of age with a body mass index greater than 85th percentile and to evaluate the effect~     of dietary and exercise intervention over 12 weeks.~   "
140426|NCT01729260|"~     The purpose of this study is to find the highest dose of mebendazole (MBZ) that can be safely~     given to people with malignant brain tumors in combination with the current standard of care~     (temozolomide) without causing severe side effects. We also want to find out if MBZ can slow~     the growth of the brain tumor. The study doctors have found that MBZ is effective against~     malignant brain tumors in the laboratory and animal models of brain tumors.~   "
140427|NCT01729247|"~     Objective: To evaluate the impact of FeNO assessments on asthma treatment decisions.~      Secondary objectives: Evaluate the ability of physicians to correctly assess airway~     inflammation using standard clinical assessment tools (i.e., prior to FeNO measurement).~     Estimate the cost consequences of changes in asthma management following FeNO determinations~      Number of participants: Approximately 40 to 50 subjects will participate in the study during~     an (approximately) 8-12 week study enrollment period.~      Reference product: NIOX MINO® Instrument (09-1100)~      Performance assessments: Fractional Exhaled Nitric Oxide (FeNO) Measurements will be~     performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO®~     User Manual (February, 2011).~      Response to Study Physician Questions before (Questions 1, 2, and 3) and after (Question 4)~     FeNO has been measured and seen by the Physician/Health Care Practitioner.~      Safety assessments: The Investigator is responsible for the detection, reporting, and~     documentation of events meeting the definition of an Adverse Event (AE) and/or Serious~     Injuries as provided in this clinical investigation plan (CIP) from the time that informed~     consent has been provided and during the study period~      Criteria for evaluation: This is an observational, pilot study and there are currently no~     plans for a formal statistical analysis. Information gained from this study may be used to~     design subsequent studies in subjects with asthma. Data collected will be summarized in a~     clinical study report but will not be subject to formal hypothesis testing~   "
140428|NCT01729234|"~     Purpose of the study is to characterize the chronic effect of dietary nitrate on vascular~     function in healthy volunteers with particular emphasis on age-related alterations.~   "
140429|NCT01729221|"~     Prospective study to calculated the incidence of hepatocellular carcinoma in hepatitis C~     virus infected patients after stem cell therapy.~   "
140431|NCT01729195|"~     This single-center randomized trial evaluates the efficacy and safety of a new bone screw~     (antibiotic releasing bioabsorbable screw) in fixation of syndesmosis in patients with Weber~     C-type ankle fractures. The comparison is made to subjects treated by conventional metal~     screw fixation of the syndesmosis. The primary objective is to show that the antibiotic~     releasing bioabsorbable screw is at least as good as the routinely used metal screw in~     prevention of syndesmosis widening in patients with Weber C-type ankle fractures. The~     secondary objective is to show that the clinical outcome of the ankle fracture treatment is~     equal between patients treated by the antibiotic releasing bioabsorbable screw and the~     conventional metal screw.~   "
140432|NCT01729182|"~     The purpose of this investigation is to collect following data in patients given Nexium~     capsule (Nexium) for long term in usual-post-marketing therapy to prevention of recurrence of~     gastric ulcer or duodenal ulcer with Low dose Aspirin (LDA).~   "
140433|NCT01729169|"~     Diagnosing cardiac sarcoidosis has always been challenging: No single imaging modality has~     proved effective and cardiac biopsies have a very low sensitivity.~     18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG) PET preceded by at least 12 hours of~     fasting has previously been demonstrated to have reasonable accuracy, however, in some~     patients physiological FDG uptake in the cardiac region hampers correct identification of~     sarcoid granulomas. Gallium Ga 68-DOTANOC is a conjugate of the somatostatin analogue~     Nal3-octreotide (NOC) and gallium Ga 68-labeled~     1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetic acid (DOTA). We aim to study whether~     68Ga-DOTANOC has superior sensitivity and accuracy than 18-FDG PET in diagnosing cardiac~     sarcoidosis. In addition, we aim to compare 18-FDG PET preceded by 12 hours fasting with~     18-FDG PET during somatostatin blockade of insulin mediated cardiac glucose uptake.~   "
140434|NCT01729156|"~     Background: Metformin treatment has beneficial effects on both glucose and lipid metabolism.~     Whereas there is general agreement that the blood glucose lowering effect of metformin~     results from inhibition of hepatic gluconeogenesis, it is less clear exactly how the drug~     lowers blood triglyceride concentration. There are indications that it enhances hepatic free~     fatty acid (FFA) oxidation thus diminishing substrate for reesterification and resecretion as~     very-low-density-lipoprotein (VLDL) triglycerides (TG). However, the liver is not easily~     accessible for sampling in humans and data on the clinical effects of metformin in the liver~     are therefore lacking. This may change due to the increasing use of the positron emission~     tomography (PET) technique. Using PET isotopes (11C or 18F) coupled to either palmitate or a~     fatty acid analogue, it is possible to non-invasively measure hepatic fatty acid handling.~      Aim: To determine how 3 months metformin treatment (1000 mg twice daily) affects hepatic~     lipid metabolism in patients with newly diagnosed type 2 diabetes.~      Design: Randomized, placebo controlled, double-blind parallel study with patients receiving~     either metformin or placebo. A control group of BMI and age-matched healthy controls will~     receive metformin for 3 months.~      Hypothesis: Metformin lowers VLDL-TG secretion and circulating triglycerides by increasing~     hepatic fatty acid oxidation~   "
140435|NCT01729143|"~     As obesity rates worldwide continue to increase, there is a focus on identifying active food~     ingredients which increase metabolic rate which can be used as a dietary supplement in the~     treatment of overweight and obesity. Promising animal and cell studies have suggested a role~     for black pepper and an active component of black pepper, piperine, in energy expenditure.~     However, the effects of black pepper have not been determined in humans. The investigators~     hypothesis if that consumption of 1.5g black pepper (0.5g in each of three meals over one~     day) will result in an elevation in 24-h resting energy expenditure when contrasted to a~     control day (no black pepper, same diet intake).~   "
140436|NCT01729130|"~     Clinical measures of adipose tissue mass (BMI, waist circumference, waist-to-hip ratio) do~     not adequately explain the inter-individual and ethnic heterogeneity in diabetes. . There is~     a need to identify novel/universal markers of risk for diabetes (DM) and cardiovascular~     disease (CVD). These biomarkers also can become additional outcome measures for an~     intervention such as pancreatic/kidney transplant. If biological markers show an improvement~     with an intervention before anthropometric changes occur, intermediate outcomes can be an~     encouraging finding for practitioners. This study will focus on the central question of~     adipose tissue dysfunction as mediator of metabolic complications of positive energy~     balance, independent of body fat content and distribution. This study will address the~     question of effect of hyperglycemia on adipose tissue function independent of body fat mass.~     This project will take advantage of unique expertise of our investigators to perform detailed~     metabolic studies in patients with diabetes who undergo pancreatic/kidney transplant. The~     results of the proposed study will provide support to the novel approach of identifying~     adipose tissue dysfunction, rather than obesity and fat distribution, as predictor of~     diabetes and CVD across all ethnic groups, age and gender. We will obtain necessary~     preliminary data for future grant submissions to support our central hypothesis and develop~     stronger interactions within and outside The University of Texas Medical Branch (UTMB) with~     clinical investigators in the area of DM and its complications.~   "
140437|NCT01729117|"~     Background and Rationale Research studies have shown that patients with type 2 diabetes~     (T2DM) who lose weight have better glucose control and less risk for heart disease. It has~     been difficult to achieve these results in a non-research setting. Meal replacements (MR) are~     pre-packaged meals with appropriate calories and nutrients that enhance adherence to a weight~     loss program by reducing decision-making and facilitating target caloric intake. The~     University of Southern California (USC) arm of the NIH funded Look AHEAD study at Roybal~     Clinic has demonstrated acceptability and success of MRs in conjunction with a structured~     lifestyle modification program in achieving weight loss in underserved Hispanic T2DM~     patients.~      Objectives Our short-term objective is to determine the efficacy, safety and feasibility of a~     3-month full MR program in conjunction with a 1 year standardized lifestyle modification~     program in a clinic setting. Our longer-term goal is to acquire data for sample size and~     power estimates for a larger NIH- or other funded prospective, randomized trial.~      Study Methodology A 1-year, prospective trial study of 30 obese subjects with T2DM treated~     with insulin randomized to 2 groups: standard care (SC) or Meal Replacement group (MR). The~     SC will receive usual care at Roybal Diabetes Management Clinic (DMC). The MR will receive~     MRs and a lifestyle course in addition to the usual clinical care at the Roybal DMC. Phase 1~     consists of 3-months 1200 -1400cal diet using full MR. Phase 2 consists of a 3-month~     transition to the same caloric intake using regular meals and 1 MR/day . Phase 3 consists of~     a 6-month weight loss maintenance period with 1 MR/day. This will be about 1400-1600~     calories/day for women and 1800 to 2000 calories/day for men. Individual and group~     educational, support and counseling visits will be components of all 3 phases of the study.~      Outcomes Efficacy of the program will be determined by weight, waist measurement and waist to~     hip ratio, blood pressure, HbA1c, lipids, and medication use at baseline and at 3, 6, 9 and~     12 months. These are all measurements that are done routinely in these patients. Safety will~     be determined by monitoring of adverse events.~      Data Analysis We will compare the outcomes between the SC and MR at 0,3,6,9 and 12 months to~     determine if there is evidence that the intervention improves outcomes and is safe.~   "
140438|NCT01729104|"~     The goal of Part 1 of this clinical research study is to find the highest tolerable dose of~     carfilzomib that can be given in combination with lenalidomide and rituximab to patients with~     relapsed or refractory B-cell non-hodgkin lymphoma.~      The goal of Part 2 of this study is to learn if the drug combination can help to control~     B-cell non-hodgkin lymphoma.~      The safety of this drug combination will be studied in both parts.~      Carfilzomib is designed to keep cancer cells from repairing themselves. If the cancer cells~     cannot repair themselves, this may cause them to die.~      Lenalidomide is designed to change the body's immune system. It may also interfere with the~     development of tiny blood vessels that help support tumor growth. This may decrease the~     growth of cancer cells.~      Rituximab is designed to attach to cancer cells and damage them, which may cause the cancer~     cells to die. It is also designed to cause the immune system to attack cancer cells.~   "
140439|NCT01729091|"~     The goal of this clinical research study is to learn if adding NK cells will help make the~     stem cell transplant more effective in treating the disease. The safety of this treatment~     will also be studied.~      NK cells may kill myeloma cells that remain in your body after your last chemotherapy~     treatment. The NK cells are separated from the umbilical cord blood sample. These separated~     NK cells will then be grown (manipulated) in the lab to increase the number of NK cells~     that can be given to you by vein.~      Elotuzumab is designed to directly activate NK cells, that may help kill myeloma cells.~      Lenalidomide (Revlimid) is designed to block a protein that plays a role in cell function and~     growth, which may cause cancer cells to die.~      Melphalan is designed to attach to the DNA (genetic material) of cells, which may cause~     cancer cells to die. It is commonly used in stem cell transplantation.~      This is an investigational study. The way researchers make the NK cells is investigational.~     At this time, it is being used in research only. The NK cell preparation will be provided at~     no cost to you.~      Lenalidomide is FDA approved and commercially available to treat patients with multiple~     myeloma who have received at least 1 prior therapy.~      Melphalan is commercially available and FDA approved for the treatment of myeloma.~      Up to 60 participants will be enrolled in this study. All will be enrolled at MD Anderson.~   "
140440|NCT01729078|"~     Assessment of glucose metabolism and liver fat after 12 week dietary intervention in pre~     diabetes subjects. Subjects will be randomized to either high fat (olive oil~     supplemented),high carb/high fiber (beans supplemented) and high carb/low fiber diets.~     Glucose metabolism will be assessed by labeled oral glucose tolerance test and liver fat by~     magnetic resonance spectroscopy pre randomization and at 8 and 12 week after starting dietary~     intervention.~   "
140441|NCT01729065|"~     This study will determine whether patients who receive regular physical therapy immediately~     following a modified neck dissection surgery will report decreased shoulder disability,~     decreased pain, improved or maintained shoulder range of motion and strength, and improved~     quality of life than those who receive only home instruction.~   "
140442|NCT01729052|"~     Postoperative nausea and vomiting (PONV) remain a significant challenge in our practice.~     However, pharmaceutical prophylaxis is only partially effective and can imply unpleasant~     adverse effects. Accordingly, the use of non-pharmacological methods in preventing PONV is~     appropriate. Acupuncture is reported to reduce PONV and pain, and the adverse events are~     minimal.~      The objective of this multicentre, double-blinded, randomized, controlled trial is to~     investigate whether acupuncture can be a supplementary to the ordinary treatment in children~     undergoing tonsillectomy and/or adenoidectomy. In addition, the non-specific effect of~     parental attitudes and expectations on the outcomes will be explored.~      Two hundred and eighty patients will be included and randomized into two groups~        1. Treatment group: acupuncture treatment (approximately 15 to 20 minutes) during~          anaesthesia and standard treatment~        2. Control group: standard treatment~      The primary endpoints in the intervention study are nausea, retching, vomiting and pain~     during 24 hours postoperatively. The effect of acupuncture will be studied with regard to any~     association with possible factors of predisposition to PONV, as well as with other factors~     registered during the study. Adverse events from acupuncture will be registered.~      The objective of the self-report questionnaires is to~        -  investigate parental attitudes and expectations to the acupuncture treatment pre- and~          postoperatively~        -  compare data of the outcomes from the intervention trial with data from the~          questionnaires, in order to find any correlation between parental beliefs, attitudes and~          expectations, and the effect of the acupuncture treatment~   "
140443|NCT01729039|"~     The purpose of this study is to determine whether vestibular exercises provide added benefit~     to balance rehabilitation in older adults with dizziness and normal vestibular function.~   "
140444|NCT01729026|"~     The purpose of this study is to provide preliminary data on the feasibility and impact of~     adopting a dog from an animal shelter as a supplement to usual care in Veterans with~     Posttraumatic Stress Disorder (PTSD) who desire to get such a pet.~   "
140445|NCT01729013|"~     Ingested or skin produced vitamin D is either hydroxylated in the liver to 25-hydroxyvitamin~     D (25(OH)D), metabolized and excreted in the urine, or stored in adipose and other tissues.~     The capacity for vitamin D storage in adipose tissue is not known, nor the importance of such~     storage which may potentially be of vital importance when intake or solar exposure is~     limited. In the present study we will include 76 subjects who have participated in an~     intervention study with vitamin D (20.000 IU per week) versus placebo for the prevention of~     type 2 diabetes, and who have completed the study after 5 years or who have been excluded~     because of diagnosed type 2 diabetes or for other reasons. If vitamin D is stored to any~     extent in the body the subjects given 20.000 IU vitamin D per week for 2-5 years will have a~     considerable amount of stored vitamin D and accordingly, a slow decline in serum 25(OH)D~     during the following year without vitamin D substitution, which will be measured in the~     present study. If our hypothesis is correct, that vitamin D can be stored in significant~     amounts when the supply is abundant; current advice on vitamin D supplementation mainly~     during winter should be changed to year around in order to build up sufficient stores for~     the months without sufficient sun light.~   "
140461|NCT01728792|"~     This study assessed the safety and immunogenicity of Takeda's Tetravalent Dengue Vaccine~     Candidate (TDV) previously referred to as DENVax of various dosing schedules via subcutaneous~     (SC) or intramuscular (IM) administration with needle/syringe or needle-free injector~     (PharmaJet Stratis™).~   "
140446|NCT01729000|"~     The purpose of this study is to compare the additional use of gloves (with handwashing before~     and after gloving) for all patient contact while infants have intravenous (central or~     peripheral) access in a RCT. Preterm infants <1000 grams or less than 29 weeks gestational~     age will be randomized after birth to either a handwashing-gloving group or handwashing only~     group. The primary outcome will be the incidence of invasive infections (bacterial or fungal)~     or necrotizing enterocolitis. Secondary outcomes will include hospital days, preterm~     morbidities, mortality, and hospital costs.~   "
140447|NCT01728987|"~     The study will examine the role of adipose tissue in vitamin D physiology, particularly its~     role as a depot. the study is randomized double blind and placebo controlled.~   "
140448|NCT01728974|"~     In obstructive sleep apnea, the upper airway recurrently closes during sleep. The mechanisms~     that lead to airway closure are not completely understood. While the airway of some people~     narrows and airflow decreases during inspiration due to increasing inspiratory effort, others~     maintain constant airflow throughout inspiration. Airway neuromuscular reflexes may protect~     against airway narrowing that occurs due to increasing inspiratory effort. To test this~     hypothesis, the investigators will initially measure airway neuromuscular reflex and~     inspiratory flow and then attenuate neuromuscular reflex through topical pharyngeal~     anesthesia to observe the effects on inspiratory flow.~   "
140449|NCT01728961|"~     The purpose of this study is to see if taking nevirapine (NVP) for HIV changes the way~     artemether/lumefantrine (AL) works in children who are co-infected with both HIV and malaria.~     The brand of AL used in this study is Coartem® Dispersible. This study will compare the blood~     levels of AL in co-infected children who already take NVP prescribed by their doctor with the~     co-infected children who do not take anti HIV medicines because they do not meet national~     guidelines to start them. The study will also assess the safety of using both medications (AL~     and NVP) in children.~   "
140450|NCT01728948|"~     This prospective, single arm, multi-center pilot study includes 120 mRCC patients over 65~     years, no prior systemic treatment, determined to be candidates for systemic therapy by the~     investigator. The treatment with Sorafenib should comply with the recommendations written in~     the local product information. The primary endpoint is overall survival. The secondary~     endpoints including other effectiveness points, safety and patients characteristics. With 120~     completed patients, if the observed survival rate at 12 months is 60%, the width of a 95%~     confidence interval will be approximately 18%.~   "
140451|NCT01728935|"~     Tenofovir (TDF) has been demonstrated to have potency antiviral against the hepatitis B virus~     (HBV) in various multiple-centre trials, with no cases of resistance encountered. However,~     its efficacy and resistance profile in the Asian population, which constitute the majority of~     chronic hepatitis B (CHB) patients, is unknown. Compared to other nucleoside analogues, TDF~     has been associated with relatively high rates of hepatitis B surface antigen (HBsAg)~     seroclearance. It would be interested to see if this could be reproduced. The investigators~     plan to report the serologic and virologic results of our 140 nucleoside analogue-experienced~     patients who were commenced on TDF.~   "
140452|NCT01728922|"~     The primary purpose of this study is to assess the immune response to vitamin D~     supplementation at two doses (5,000 IU and 10,000 IU daily) in both healthy controls and~     patients with clinically isolated syndrome compared to placebo. Secondary endpoints include~     (1) disease outcome in the clinically isolated syndrome in terms of clinical relapses and~     evidence of new lesions on MRI (McDonald's MS), 2) Safety of doses used~   "
140453|NCT01728909|"~     The purpose of the study is to examine the effects of intranasal oxytocin administration on~     social cognition in patients receiving methadone maintenance treatment (MMT), examine the~     effects of intranasal oxytocin administration on opioid craving and on the subjective effects~     of methadone, and examine the effects of intranasal oxytocin administration on implicit~     preferences for drug-related and social stimuli in patients receiving MMT.~      Hypothesis 1: Patients will perform better on measures of social cognition (including affect~     recognition and recognition of sarcasm) after administration of oxytocin compared with~     placebo.~      Hypothesis 2: Patients will demonstrate lower craving for opioids and greater subjective~     effects of methadone after administration of oxytocin compared with placebo.~      Hypothesis 3: Patients will demonstrate increased implicit preferences for social stimuli and~     decreased implicit preferences for drug related stimuli after administration of oxytocin~     compared with placebo.~   "
140454|NCT01728896|"~     The first step in treating patients with acute pancreatitis is to provide pain relief and~     intravenous fluids to keep them comfortable. As the pain subsides and patient starts to feel~     better food and fluids by mouth are restarted. This is done to rest the pancreas which is the~     organ that has been inflamed.~      In some patients when food by mouth restarts they have pain and as a consequence they have a~     longer stay in hospital. It is thought that patients who have little pain and are within 24~     hours of admission to hospital do well if they control their own food intake. This is in~     contrast to the usual treatment where the treating team advise when eating should restart.~   "
140455|NCT01728883|"~     The purpose of this study is to determine the effect of enhancements to the myVisionTrack® in~     regards to patient compliance and test-retest variability. Additionally, the ability of~     myVisionTrack® to detect changes in vision function will be evaluated.~   "
140456|NCT01728870|"~     The purpose of this study is to assess the efficacy and tolerability of a novel dietary~     intervention for early CD based on partial enteral nutrition, and to compare it to the gold~     standard but difficult to implement dietary intervention- Exclusive enteral nutrition with~     Modulen .~   "
140457|NCT01728857|"~     Evaluate the effects of tissue optimization before and during cryolipolysis procedures on the~     outcome of non-invasive fat reduction using the ZELTIQ System.~   "
140458|NCT01728831|"~     This proposal aims to provide some objective, non-invasively achieved, physiologically~     relevant data in order to provide some rational basis for decision-making for transfusion in~     sTBI. Specifically this proposal is an observational study of transfusion and brain tissue~     saturation in sTBI patients. The results will illustrate to what degree brain tissue~     oxygenation is critically dependent on the degree of anemia in sTBI and help in the decision~     of whether transfusion might be helpful.~   "
140459|NCT01728818|"~     Single-agent gemcitabine is currently still regarded as one international standard of care~     for patients with advanced pancreatic cancer (Burris 1997 [4]). The oral EGFR tyrosine kinase~     inhibitor erlotinib received EMEA-approval for the treatment of patients with metastatic~     pancreatic cancer in January 2007.~      In the pivotal phase III trial, the combination of gemcitabine plus erlotinib was associated~     with a statistically significant prolongation of OS (compared to single-agent gemcitabine),~     however, the absolute survival benefit was - for the overall study population - clinically~     moderate (median OS: 6.24 vs 5.91 months, 1-year OS rate: 23% vs 17%; HR = 0.82, p=0.038)~     (Moore 2007 [19]).~      The recently presented FOLFIRINOX regimen shows enhanced activity in metastatic pancreatic~     cancer patients. This regimen is, however, limited to patients with good performance status~     (ECOG 0-1), no major comorbidity, age <75 years, and bilirubin <1.5 ULN (Conroy 2011 [6]).~     The majority of pancreatic cancer patients will therefore not be treated with this regimen.~      Accordingly, novel treatment concepts are urgently needed in pancreatic cancer and~     pre-clinical data indicate an important role of the EGFR1/erbB2 receptor signalling in the~     pathogenesis of pancreatic adenocarcinoma (Yeh 2007 [24]). A recent publication (Larbouret~     2010 [16]) indicates that the combination of cetuximab and trastuzumab induced superior~     antitumour activity in human pancreatic carcinoma xenografts compared to gemcitabine alone~     (see also Larbouret 2007 [15]). Furthermore, synergistic antitumour activity was observed~     when monoclonal antibodies directed against the EGFR1 and erbB2 were combined (Ben-Kasus 2009~     [3]). Based on these data, there is a good rationale to further investigate the combined~     inhibition of the erbB family in pancreatic cancer patients.~      Afatinib (BIBW 2992) is a novel irreversible EGFR1- and HER2 and HER4 inhibitor that is~     applied orally. The purpose of the present trial is to investigate the erbB family inhibition~     by afatinib in patients with metastatic pancreatic cancer.~      In the planned trial, afatinib will be applied at the dose (40 mg/day) that was chosen for~     the randomised phase III trial (LUX 5 study) that investigates afatinib plus weekly~     paclitaxel (80mg/m2).~      Presently there is also a phase I study ongoing that investigates the combination of afatinib~     with gemcitabine (ClinicalTrials.gov Identifier: NCT01251653 U10-2249-02 ). Possibly the data~     will be available once the study is ready to start. Otherwise a modification of the regimen~     will be planned once the respective data will be available.~      In this trial, we integrate a translational project which may allow the identification of~     patients that primarily benefit from this novel treatment approach. The availability of~     tumour tissue- and blood samples from each patient is therefore an important inclusion~     criterion.~      A 2:1 randomisation is chosen favouring the experimental arm since a large body of data is~     available on gemcitabine alone and since sufficient efficacy and toxicity data shall be~     gained in the experimental arm. In addition, the patients' motivation to take part in the~     trial will be greatly enhanced by a greater chance to receive the experimental agent.~   "
140460|NCT01728805|"~     The purpose of this study is to compare the progression free survival of KW-0761 versus~     vorinostat for subjects with relapsed or refractory CTCL.~   "
140462|NCT01728779|"~     Patients with metastatic lesions of the lung, liver, or bone will be candidates for~     treatment. Within three weeks of the initial treatment planning, a 15 Gy dose (per lesion~     site) of SBRT will be administered. Prior to SBRT, patients will initiate Nelfinavir oral~     therapy twice daily for 7 days. Once SBRT is completed, the patient will repeat the same~     Nelfinavir therapy for an additional 7 days for a total of 14 days of treatment.~   "
140463|NCT01728766|"~     Data collected from this study will provide information on the breast milk zinc~     concentration, maternal and infant zinc status, and transfer of zinc from mothers breast milk~     to infants during first six months of life.~   "
140464|NCT01728753|"~     This is safety and pharmacokinetics (PK) of favipiravir study in adults 18-80 years of age~     diagnosed with uncomplicated influenza.~   "
140465|NCT01728740|"~     To establish the bioequivalence between Acarbose / Metformin FDC (50mg / 500mg) and loose~     combination of Acarbose (Glucobay) (50mg) and Metformin (Glucophage) (500mg).~   "
140466|NCT01728727|"~     HBV related Liver disease is a common medical problem in China. An estimated 7.18% of the~     Chinese (about 93 million) is infected with hepatitis B, and most of the HBV- related~     hepatitis can developed into liver cirrhosis.~      Liver transplantation is the only available life saving treatment for patients with end stage~     liver disease. However, lack of donors, surgical complications, rejection, and high cost are~     serious problems.~      Mesenchymal stem cells (MSCs) possess plasticity and have the potential to differentiate into~     hepatocyte; Thus, MSCs hold great hope for therapeutic applications. Human umbilical~     cord-derived MSCs (hUC-MSCs) exhibit a more beneficial immunogenic profile and greater~     overall immunosuppressive potential than aged bone marrow-derived MSCs. Like MSCs derived~     from bone marrow, hUC-MSCs can also be used to treat rat liver fibrosis and improve glucose~     homeostasis in rats with liver cirrhosis. In this study, the patients with HBV-related liver~     cirrhosis will undergo administration of hUC-MSCs via hepatic artery to evaluate the safety~     and efficacy of hUC-MSC treatment for these patients.~   "
140467|NCT01728714|"~     Prospective study to evaluate the impact of an educational programme about diabetes,~     comparing to normal clinical practice, on treatment compliance and disease control of people~     with type 2 diabetes followed in the primary care units in Portugal.~   "
140468|NCT01728701|"~     The purpose of the study is to determine the safety and tolerability of ID administration of~     PfSPZ Challenge to volunteers taking chloroquine chemoprophylaxis (an approach called~     PfSPZ-CVac).~   "
140469|NCT01728688|"~     HBV related Liver disease is a common medical problem in China. An estimated 7.18% of the~     Chinese (about 93 million) is infected with hepatitis B, and most of the HBV- related~     hepatitis can developed into liver cirrhosis.~      Liver transplantation is the only available life saving treatment for patients with end stage~     liver disease. However, lack of donors, surgical complications, rejection, and high cost are~     serious problems.~      In preclinical studies the investigators have demonstrated that G-CSF mobilized PBSC from~     patients with HBV related liver cirrhosis could differentiate into functional hepatocyte and~     autologous PBSC transplantation can significantly improve liver synthetic function. But~     further studied was needed to confirm the safety and efficacy of PBSC transplantation. In~     this study, a prospective, randomized, parallel clinical study was designed. The patients~     with HBV-related liver cirrhosis will undergo administration of human autologous PBSCs via~     hepatic artery to evaluate the safety and efficacy of human autologous PBSCs treatment for~     these patients.~   "
140470|NCT01728675|"~     The purpose of the present investigation is to compare the responses and adaptations of young~     and elderly individuals to repeated eccentric exercise in regards to muscle function and~     redox homeostasis in a side-by-side comparison.~   "
140471|NCT01728662|"~     This study will test that hypothesis that endoscopic lung volume reduction therapy performed~     using emphysematous lung sealant treatment can be improved using smaller doses delivered to~     more a larger number of treatment sites.~   "
140472|NCT01728649|"~     The purpose of this study is to determine whether reducing a patients body temperature (mild~     hypothermia of 33 degrees Centigrade) will significantly reduce the risk of brain injury~     (notably reperfusion injury and hemorrhagic conversion) in patients that have suffered a~     significant interruption of blood flow to an area of brain (occlusion of large proximal~     cerebral artery) and have undergone successful removal of that interruption~     (revascularization).This will be achieved by comparing patients that have undergone~     hypothermia to those that have not.~   "
140473|NCT01728636|"~     The purpose of this study is to determine if tranexamic acid reduces perioperative blood loss~     and red blood cell transfusion during high risk spine surgery.~   "
140474|NCT01728623|"~     This study is to evaluate the safety, efficacy, and pharmacokinetics of E7080 when orally~     administered once daily (QD) in subjects with advanced thyroid cancer.~   "
140475|NCT01728610|"~     The purpose of this study is to analyse the effect of a probiotic supplement on functional~     intestinal symptoms among subjects diagnosed with irritable bowel syndrome (IBS).~   "
140476|NCT01728597|"~     One of the main problems in cardiac magnetic resonance (MR) investigations is the strong~     dependence of the achieved image quality on optimal settings of sequence parameters and~     anatomical and physiological situations and it is well known that the diagnostic impact of~     cardiac MR investigations crucially depends on the adaption of imaging protocols to patients'~     state and ability to cooperate.~      The aim of the present study is the evaluation and optimization of various 1.5 Tesla and 3~     Tesla cardiac MR investigation protocols without application of contrast agent as well as the~     acquisition of normal values for new cardiac MR images techniques:~        -  normal myocardial morphology: T1-, T2- and T2*-weighted imaging and acquisition of~          normal values of magnetic relaxation times (sequence- and protocol dependent),~        -  normal cardiac function: systolic and diastolic function (sequence- and protocol~          dependent),~        -  coronary artery imaging: feasibility to evaluate length, diameter and blood flow~          (sequence- and protocol dependent),~        -  normal blood flow topologies in the heart and the surrounding great vessels: 2D- and 3D~          blood flow imaging and evaluation techniques (sequence- and protocol dependent).~   "
140518|NCT01728051|"~     The safety and efficacy of CS-PHP-melphalan has been evaluated in a phase 3 trial conducted~     in the same patient population as well as using the same melphalan dosing as proposed in this~     study. This expanded access protocol will provide an experimental alternative treatment~     option for both physicians and patients until the Delcath CS-PHP System receives marketing~     approval.~   "
140477|NCT01728584|"~     The purpose of this pilot study is to compare the use of deep or standard neuromuscular~     blockade (NMB) in combination with low or standard insufflation pressure in participants~     undergoing a surgical procedure, laparoscopic cholecystectomy. Insufflation refers to the~     injection of carbon dioxide into the abdomen during the laparoscopic surgery, to allow~     visualization of and access to the surgical field. The primary hypothesis of the study is~     that the use of sustained deep NMB improves the surgeon's overall satisfaction with surgical~     conditions as compared to standard NMB. The in-patient surgery is performed on Day 1 and the~     participant remains hospitalized for at least 48 hours following the surgery (or at least 24~     hours following the surgery, if local practice does not allow 48 hours of hospitalization~     post surgery). On Day 8, a follow-up visit/contact including all participants occurs.~   "
140478|NCT01728571|"~     The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial~     in 25,875 U.S. men and women investigating whether taking daily dietary supplements of~     vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of~     developing cancer, heart disease, and stroke in people who do not have a prior history of~     these illnesses.~      This ancillary study is being conducted among participants in VITAL and will examine whether~     vitamin D or fish oil improves respiratory symptoms or reduces the risk of lung infections or~     reduces the decline of pulmonary function.~   "
140479|NCT01728558|"~     The Use of sedative drugs in intensive care is widespread. A cohort study conducted in~     Australia and New Zealand in 2010 revealed a high prevalence of deep sedation within the~     first 48 hours of mechanical ventilation which was independently linked to prolonged~     ventilation, hospital and 180 days mortality. Clinical practice is moving towards the use of~     lighter levels of sedation. Recent RCTs in Europe (JAMA 2012) and previous RCTs (JAMA 2009)~     supports growing evidence that dexmedetomidine facilitates rousable sedation, shortens~     ventilation time and attenuates delirium when compared to midazolam and propofol.~      The investigators confirmed in a pilot study the feasibility, efficacy and safety of a~     process of care known as Early Goal Directed Sedation (EGDS) that delivers:~        1. Early randomization after intubation or arrival in the ICU (intubated).~        2. Early Adequate analgesia after randomization.~        3. Goal directed sedation titrated to achieve light sedation.~        4. Dexmedetomidine based algorithm as the primary sedative agent with avoidance of~          benzodiazepines.~      The aim of this study is to assess the effectiveness of Early Goal Directed Sedation when~     compared to standard care sedation in critically ill patients.~      The study hypothesis is that Early Goal-Directed Sedation (EGDS), compared to standard care~     sedation, reduces 90-day all-cause mortality in critically ill patients who require~     mechanical ventilation.~   "
140480|NCT01728545|"~     The goal of this study is to collect blood samples from the umbilical cords of newborn~     babies, as soon as they are delivered, and to place these samples in the MD Anderson Cord~     Blood Bank. Your sample may be included in the National Cord Blood Inventory (NCBI) which is~     part of the CW Bill Young Cell Transplantation Program. The NCBI is a federally-supported~     program to assist in the collection of cord blood. Cord blood will be made available to~     patients through The National Marrow Donor Program (NMDP). These samples may then be offered~     to MD Anderson and other institutions for patients who need a bone marrow transplant and do~     not have a donor. The MD Anderson Cord Blood Bank will have the rights to release cord blood~     units to these institutions around the world according to established bone marrow transplant~     donor criteria, for a fee to cover costs.~      Cord blood samples that are collected and then do not meet the clinical requirements for~     patient use may also be used at MD Anderson or other institutions either for research or for~     quality purposes to improve cord blood banking procedures. If not suitable for patient use or~     for research purposes, the cord blood unit may be thrown away.~   "
140481|NCT01728532|"~     TRIAL TITLE: Open, randomized multicentric trial evaluating the efficacy and the clinical~     tolerance of PA0903 as root canal sealer~      SPONSOR:~      SEPTODONT, 58 rue du Pont de Créteil, 94107 Saint Maur des Fossés cedex Tel : + 33~     1-49-76-74-26, Fax. : + 33 1- 49-76-71-91~      Reference protocol: 11/001~      PRODUCT NAME: PA0903~      MEDICAL DEVICE:~      Class III: Root canal sealer Dose: not applicable Application : one single time~      DEVELOPMENTAL PHASE: not applicable (medical device class III)~   "
140482|NCT01728519|"~     Birch pollen allergic patients are currently treated by subcutaneous injections of pollen~     extracts either by standard allergen specific immunotherapy (SIT) or ultra-rush~     immunotherapy. Such treatment is prone to side effects and has to be performed in a hospital~     environment due to the risk of potential anaphylactic reactions. The aim of this study is to~     test the new product AllerT expected to show widely reduced side effects. AllerT will be~     injected via two different routes, subcutaneous versus intradermal. The primary endpoint of~     the study is the local and systemic safety of repeated injections of the product. Since~     AllerT should provide patients with a pre-seasonal treatment to decrease seasonal allergic~     symptoms, we will also evaluate the potential efficacy of the approach using a nasal~     provocation test (NPT) with birch pollen~   "
140483|NCT01728506|"~     The purpose of this study is to test the effectiveness of a behavioral weight loss and~     exercise intervention delivered via the internet at different cancer centers in New England.~     The investigators hypothesize that participants will lose 7% of their body weight. The~     research is being done because many women who are treated for breast cancer are overweight~     and treatment for breast cancer is often accompanied by weight gain. Individuals who are~     overweight may be more likely to have their breast cancer come back. Also women who exercise~     at least three hours a week seem to have less chance of their cancer coming back. The~     investigators hope to identify an effective weight loss and exercise intervention for breast~     cancer survivors that can be easily accessed by many people.~      This study is designed to determine the feasibility of conducting a distantly~     delivered-weight loss and exercise intervention for patients who have been treated for breast~     cancer at three cancer centers, and to evaluate the efficacy of an Internet-based behavioral~     weight loss and exercise intervention delivered to overweight/obese breast cancer survivors~     in three New England locations.~      Participants will be recruited from three New England Cancer Centers - the Vermont Cancer~     Center, Norris Cotton Cancer Center at Dartmouth University and the University of~     Massachusetts Cancer Center. Participants from each center will undergo baseline assessments~     that include diet assessment, body measurements (height, weight, etc), a physical activity~     assessment and be asked to complete a series of questionnaires.~      Patients that meet the minimum requirements will be enrolled on the study. They will~     participate in weekly on-line chats about behavioral and diet modifications led by a~     qualified facilitator. Participants will also engage in increasing amounts of aerobic~     activity (typically walking) throughout the course of the intervention. The intervention~     lasts 6 months. At the end of those 6 months, participants will have the same assessments~     that were collected at baseline. Following the collection of those assessments, participants~     will have completed the study.~   "
140533|NCT01727856|"~     Rehabilitation exercise conducted at home following injury improves clinical and functional~     outcomes. Optimum compliance with prescribed exercise regimens requires regular patient~     instruction, performance assessment, monitoring and general encouragement from healthcare~     staff. Exercise at home though convenient for patients is not conducive for provision of the~     professional support needed to maximize prescribed regimen effectiveness.~      Software in development by Reflexion Health Inc. along with the Naval Medical Center San~     Diego (NMCSD) is being designed to facilitate remote staff-patient interaction during at-home~     rehabilitative exercise sessions. Microsoft Kinect® will serve as the hardware platform for~     the designed software package tentatively called, Reflexion. Kinect® contains a~     marker-less/controller-less motion tracking camera. The final Reflexion software will rely on~     a Rehabilitation Measurement Tool (RMT) to detect cardinal plane skeletal joint movement~     and its velocity utilizing the embedded Kinect® camera while also providing patient visual~     feedback via an avatar on a television screen.~      In this observational minimal risk study, RMT/Kinect® functional reliability and usability~     will be assessed. Twenty healthy subjects will physically set-up and turn-on the~     hardware/software system; receive exercise directions from the RMT; then conduct a series of~     knee exercises similar to those prescribed after anterior cruciate ligament (ACL) repair.~      An initial limited data set, obtained by Reflexion Health, provided validity and reliability~     measures. Eighteen degrees of absolute difference was detected between manual goniometry and~     Kinect® measurements in relevant planes of movement utilized during prescribed ACL exercise.~     Good relative agreement between RMT and goniometry scores was obtained (ICC = 0.89). A~     correctable systematic bias toward underestimation by the RMT will allow for future more~     accurate estimations of joint positioning improving face validity.~      RMT functional reliability and general usability will be expressed in this study utilizing~     descriptive statistics and scaled questionnaires. Hardware component malfunction (Kinect®~     camera, laptop, PC, or LCD television/monitor) as well as RMT internally logged software~     errors and failure will tallied and measured to ascertain RMT reliability.~      User-RMT interaction quality will be evaluated with video recordings of each set-up and~     exercise session. Specifically, usability measures will include: need for additional~     assistance setting-up or operating the RMT; number of attempts required by the subject to~     interact with a specific feature: time spent on specific elements during the session.~     Participant feedback will be elicited post-session using two scaled questionnaires: System~     Usability Scale (SUS)and Reflexion Usability Scale (RUS). Findings from the study will guide~     software modifications needed prior to implementation of future clinical studies within the~     NMCSD population.~   "
140636|NCT01726491|"~     The investigators are trying to understand the role of DNA (deoxyribonucleic acid)~     methylation in insulin resistance in skeletal muscle and blood tissues. DNA methylation is a~     normal chemical process in the body that modifies DNA. By studying this, the investigators~     hope to better understand the causes of insulin resistance.~   "
140484|NCT01728493|"~     Primary aldosteronism (PA) is the most frequent form of secondary hypertension. It is caused~     by autonomous secretion of aldosterone, encompassing a group of disorders which is for 99%~     predominated by unilateral aldosterone-producing adenoma (APA) and bilateral adrenal~     hyperplasia (BAH). Diagnosis of PA is relevant for two reasons:~        1. independent of the level of blood pressure, hypertension due to autonomous aldosterone~          secretion causes more cardiovascular damage than essential hypertension;~        2. PA requires specific treatment: adrenalectomy in case of APA and mineralocorticoid~          receptor antagonists (MRA) in case of BAH.~      Although previously presumed a rare condition (prevalence <1%), PA is now estimated to affect~     6 to 20% of the hypertensive population. Given this high prevalence of PA, as well as the~     amount of cardiovascular damage and the available specific treatment, the question is raised~     whether screening of PA should be introduced in Dutch general practice. To answer this~     important question, several issues with regard to PA need to be elucidated:~        1. International studies report a prevalence of PA in general practice of 6-13%. Prevalence~          in the Dutch population is still unknown;~        2. Because of underdiagnosis of PA and long delay in diagnosis of PA after recognition of~          hypertension (mean eight years), data on characteristics of early diagnosed PA are~          lacking. Proof of early cardiovascular damage would strengthen the case of screening for~          PA and needs to be studied;~        3. Consequently, the diagnostic delay has lead to lack of data on optimal treatment in~          early PA. In the current guideline (NHG-guideline 'Cardiovascular risk management') a~          regimen of antihypertensive drugs is advised, and only if hypertension is refractory for~          >6 months patients are referred. It is unknown if hypertension is resistant to therapy~          in the initial phase of PA. If not, this would also argue for early biochemical~          screening for PA, because even if blood pressure is controlled, the detrimental effect~          of aldosterone itself will go on unopposed. It is therefore required to study the~          response to antihypertensive drugs (not MRA) in these patients.~   "
140485|NCT01728480|"~     This phase I trial studies the side effects and best dose of entolimod in treating patients~     with stage III-IV or recurrent head and neck cancer. Biological therapies, such as entolimod,~     may stimulate the immune system in different ways and stop tumor cells from growing.~     Entolimod may also prevent side effects caused by chemotherapy with cisplatin and radiation~     therapy. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in~     chemotherapy, such as cisplatin, work in different ways to stop the growth of cancer cells,~     either by killing the cells or by stopping them from dividing. Giving entolimod together with~     cisplatin and radiation therapy may kill more tumor cells~   "
140486|NCT01728467|"~     This study builds on data that high-density lipoprotein (HDL) has a number of potentially~     beneficial effects including directly modulating glucose metabolism through multiple~     mechanisms. The primary objective of this study is to determine the effects of RVX000222 on~     postprandial plasma glucose in male individuals with impaired fasting glucose (IFG) or~     impaired glucose tolerance (IGT), during a frequently sampled oral glucose tolerance test~     (OGTT).~   "
140487|NCT01728454|"~     The primary objective of this study is to determine the safety and efficacy of two oral doses~     of Proellex administered to premenopausal women with pelvic pain associated with~     endometriosis confirmed within the last seven years and using prescription analgesics for~     symptomatic pain.~   "
140488|NCT01728441|"~     Objective of the REAL PTX trial is to compare paclitaxel-eluting stents to paclitaxel-eluting~     balloons for treating symptomatic peripheral artery disease of the femoropopliteal artery.~   "
140489|NCT01728428|"~     To determine the clinical manifestation, diagnosis and treatment options of primary~     hemifacial spasm in Chinese outpatient subjects~   "
140490|NCT01728415|"~     The purpose of this study is to evaluate the effects of high intensity interval training~     compared to moderate exercise training and a control group on exercise capacity and quality~     of life in patients with end stage renal disease on hemodialysis.~   "
140491|NCT01728402|"~     The cause of blood and bone marrow cancers is poorly understood; however, most research~     focuses on how cancer cells grow and develop. Because the causes of these cancers are~     unknown, current treatments may be unnecessarily harsh and often do not provide a cure.~     Identifying the causes of blood cancers would allow for the development of treatments that~     are more likely to provide a cure. To find the causes of blood and bone marrow cancers, we~     will look for specific cancer cell abnormalities that are responsible for cancer cell growth.~     We will then look to see if drugs that can reverse these abnormalities can kill cancer cells.~   "
140492|NCT01728389|"~     The purpose of the study is to evaluate efficacy and safety of direct intrabone~     transplantation procedure of peripheral blood haematopoietic stem cells form HLA-matched~     sibling donors in patients with myeloid and lymphoid malignancies.~   "
140493|NCT01728376|"~     The intent of this study is to describe the safety and efficacy of daptomycin versus standard~     of care (SOC) in pediatric participants aged 1-17 years with bacteremia caused by~     Staphylococcus aureus (S. aureus).~   "
140494|NCT01728363|"~     Multiple center, open-label, PK study~   "
140495|NCT01728350|"~     The purpose of this project is to determine if participating in volunteer activity improves~     the psychological well-being of individuals with traumatic brain injury (TBI).~   "
140496|NCT01728337|"~     this study was proposed to provide more scientific and objective data on the clinical and~     aesthetic effects of these two toxins (Dysport and Xeomin).~   "
140497|NCT01728324|"~     The aim of the study is to confirm efficacy and safety of treatment with 600 mg of BID BI~     207127 in combination with 120 mg QD FDV and RBV for 16 or 24 weeks in target chronically~     infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.~   "
140498|NCT01728311|"~     The purpose of this study is to determine the safety, tolerability and the pharmacokinetics~     of BAY1082439~   "
140499|NCT01728298|"~     The primary objective of the trial is to evaluate the dose-response relationship with regards~     to change in immunological parameters and safety for SLITone ULTRA house dust mite mix in~     adult subjects with moderate to severe HDM allergic rhinitis.~   "
140500|NCT01728285|"~     Adherence to treatment is crucial to the efficacy of sublingual immunotherapy of allergic~     diseases. GRAZAX® is a registered drug in Europe, with established efficacy in the treatment~     of allergic rhinitis, which has to be taken daily by patients. This study was aimed to~     establish if a device with the characteristics of a mechanical dispenser (Memozax®) could~     improve adherence to treatment in subjects with hay fever due to allergy to grass~   "
140501|NCT01728272|"~     Influence of perfusion, miniperfusion and off pump coronary artery bypass grafting to the~     absorbtion of metoprolol postoperatively, hypothesis in that miniperfusion and off pump~     surgery does not decrease absorbtion of the metoprolol compared to conventional pefusion.~   "
140590|NCT01727089|"~     This randomized phase II trial studies how well bevacizumab with or without anti-endoglin~     monoclonal antibody TRC105 (TRC105) works in treating patients with kidney cancer that has~     spread to other parts of the body (metastatic). Monoclonal antibodies, such as bevacizumab~     and anti-endoglin monoclonal antibody TRC105, may block tumor growth in different ways by~     targeting certain cells.~   "
140502|NCT01728259|"~     This phase I trial studies the side effects and best dose of pomalidomide and bortezomib when~     given together with dexamethasone in treating patients with amyloid light-chain amyloidosis~     or light chain deposition disease. Biological therapies, such as pomalidomide, may stimulate~     the immune system in different ways and stop abnormal cells from growing. Bortezomib may stop~     the growth of abnormal cells by blocking some of the enzymes needed for cell growth. Giving~     pomalidomide and bortezomib together with dexamethasone may be an effective treatment for~     amyloid light-chain amyloidosis or light chain deposition disease~   "
140503|NCT01728246|"~     The purpose of this study is to evaluate the efficacy, safety and effects on Quality of Life~     (QOL) of tramadol/paracetamol (APAP) as an add-on therapy (medication taken in addition to~     another medication) in Filipino participants with chronic (lasting a long time)~     osteoarthritis (disorder, which is seen mostly in older persons, in which the joints become~     painful and stiff).~   "
140504|NCT01728233|"~     Penile squamous cell carcinoma (SCC) is a very rare disease and prognosis depends primarily~     on regional lymph-node involvement. Despite the fact that cure can be obtained in patients~     with low metastatic load (pN1) by monotherapy, combination therapy is required for more~     advanced cases. Medical treatment options only for advanced or metastatic penile SCC are not~     very effective so far and the few chances for cure are solely dependent on multimodality~     treatment, either with surgery or radiation. Based on the observation that the epidermal~     growth factor receptor (EGFR) is almost invariably expressed in penile SCC and assuming~     similarities to the SCC of head and neck district, anti-EGFR targeted monotherapy has been~     investigated with promising early results at Istituto Tumori Milan and University of Texas MD~     Andreson Cancer Center. These premises lend support to the use of the pan-HER inhibitor~     dacomitinib for advanced or metastatic penile SCC.~   "
140505|NCT01728220|"~     This is a placebo-controlled, double-blind, parallel, randomized, two-part, dose-confirming~     clinical study characterizing the pharmacodynamic effects of pulsed iNO using the combination~     product, inhaled nitric oxide/INOpulse DS-C vs. placebo in subjects with World Health~     Organization (WHO) Group 3 pulmonary hypertension (PH) associated with Chronic Obstructive~     Pulmonary Disease (COPD) on Long Term Oxygen Therapy (LTOT).~   "
140506|NCT01728207|"~     IMMU-114 will be studied at different dose schedules and dose levels in order to assess the~     highest dose safely tolerated. IMMU-114 will be administered subcutaneously (under the skin).~     IMMU-114 will be given 1-2 times weekly for 3 weeks followed by one week of rest. This is~     considered one cycle. Treatment cycles will be repeated until toxicity or worsening of~     disease.~   "
140507|NCT01728194|"~     This study may help identify how abnormalities in brain systems that control the ability to~     ignore irrelevant information may contribute to the development of depression in older~     adults.~   "
140508|NCT01728181|"~     The current trial A Phase I/II study of Erlotinib +/- Tivozanib as initial treatment for~     Metastatic Non-small Cell Lung Cancer assigned by VeriStrat® Serum Proteomic Evaluation will~     begin by evaluating toxicity for the combination of Tivozanib and Erlotinib to determine a~     phase II dose. The phase II portion of the study will seek to duplicate the finding of the~     BEER trial in a selected population of patients with NSCLC with a VeriStrat® Good signature~     using two oral agents with Tivozanib substituted for bevacizumab. Phase II will be designed~     as a selection-based randomized trial. Patients with VeriStrat® Good signature will be~     assigned to EGFR inhibitor therapy with a randomization to Erlotinib plus/minus Tivozanib.~     Patients with VeriStrat® Poor signature will be assigned to standard of care.~     Standard-of-care chemotherapy as first treatment at the discretion of patient and physician~     will be evaluated for response to treatment, survival and repeat VeriStrat® signature.~   "
140509|NCT01728168|"~     The objective of the study is to assess the prevalence of a sensitization to proteins from~     legumes by skin prick test using commercial extracts (peanut, soy, and pea) and raw material~     (lupin) in atopic and healthy subjects.~   "
140510|NCT01728155|"~     The European study, LINES 2009 (Low and Intermediate Risk Neuroblastoma European Study),~     groups together in a single protocol the treatment of all patients with non high risk~     neuroblastoma (NB), with stratification into two groups: low risk and intermediate risk.~     These two separate cohorts are included in one single protocol to enable patient data from~     these two groups to be entered into a common database, as the current prognostic~     classifications determining treatment may evolve further with subsequent more detailed~     molecular analysis of the tumours.~      1. LOW RISK STUDY~      The Low Risk Study is proposed in order to:~        -  minimise the amount of treatment (chemotherapy and surgery) for all appropriate low risk~          patients, who in previous studies have been shown to have an excellent long-term outcome~          (as in the SIOPEN 99.1-2 infant neuroblastoma studies where the overall survival was~          greater than 97%(H. Rubie, JCO).~        -  improve the EFS and maintain the OS (overall survival) in L2 and Ms patients with a~          SCA(Segmental Cromosomal Aberration) genomic profile tumour (presence of any segmental~          chromosomal change (SCA)) by electively treating these patients with chemotherapy~          despite the absence of symptoms.~           2) INTERMEDIATE RISK STUDY~      The Intermediate Risk Study is proposed in order to:~        -  reduce the amount of chemotherapy for differentiating histology INRG (International~          Neuroblastoma Risk Group) stage L2 NB and ganglioneuroblastoma nodular patients who in~          previous SIOPEN study have been shown to have an excellent long-term outcome;~        -  increase the amount of treatment (radiotherapy and 13-cis-RA (13-cis-Retinoic Acid) for~          poorly differentiated or undifferentiated histology INRG stage L2 NB or~          ganglioneuroblastoma nodular patients in order to improve the EFS registered in the~          previous SIOPEN study;~        -  improve the EFS (Event Free Survival) of MYCN (V-Myc myelocytomatosis viral related~          oncogene, NB derived ,avian )amplified INSS (International NB Staging System) stage 1 NB~          patients with the introduction of adjuvant treatment;~        -  maintain the very good results obtained in previous SIOPEN study for INRG stage M~          infants with a moderate treatment.~      NEONATAL SUPRARENAL MASSES~      The incidence of suprarenal tumours/masses has increased in the last decade due to the~     expanded use of prenatal ultrasonography in routine obstetric care and in the neonatal and~     early infancy care. The differential diagnosis of these masses ranges from benign (adrenal~     haemorrhage) to malignant processes (neuroblastoma, adrenal carcinoma). Knowledge on~     perinatal suprarenal masses, although based on a relatively large literature, is scattered~     amongst studies on very few cases with no methodical approach and often short follow up.~     Therefore, the optimal management of these masses has not been clearly defined. Neuroblastoma~     at this age is an intriguing entity with a very good prognosis in most cases. The SIOPEN~     Group, based on their results in the first multicenter European Trial for infants with~     neuroblastoma (INES) and the world-wide experience provided in the literature, is launching~     this European surveillance study (Multi-centre, non-blinded, one armed prospective trial) for~     these masses. Treatment: Observation~   "
140511|NCT01728142|"~     The Defense Automated Neurobehavioral Assessment (DANA) was recently developed as a durable,~     portable, and field-hardened NeuroCognitive Assessment Tool. The purpose of this study is~     to compare the sensitivity of the DANA Brief exam with the Automated Neuropsychological~     Assessment Metrics (ANAM) battery currently used by the military after concussion. The~     primary hypothesis is that the DANA Brief exam will be more sensitive for detecting continued~     impaired cognitive performance than the ANAM during recovery after a concussion.~   "
140512|NCT01728129|"~     The purpose of this study is to compare the sensitivity of the DANA Rapid exam with the MACE~     cognitive score. The primary hypothesis is that the DANA Rapid exam will be more sensitive~     for detecting impaired cognitive performance than the MACE cognitive score in the setting of~     a clinical diagnosis of concussion at the point of injury in the combat setting. A secondary~     purpose of this study is to examine a serial performance on the DANA Rapid exam in those~     subjects diagnosed with a concussion. The secondary hypothesis is that the DANA Rapid exam~     will show improvements in performance during the recovery period after concussion.~   "
140513|NCT01728116|"~     To determine if the EndoBarrier safely and effectively improves glycemic control in obese~     subjects with type 2 diabetes~   "
140514|NCT01728103|"~     The objective of this study is to obtain female first-catch urine, vaginal, cervical and~     endocervical swabs for testing with multiple APTIMA Assays on the Gen-Probe PANTHER® and~     TIGRIS® Systems.~   "
140515|NCT01728090|"~     The aim of the study was to assess the effectiveness of a hand-washing programme using hand~     sanitizer in the prevention of school absenteeism due to upper respiratory infections.~     Students in intervention classrooms used hand sanitizers at schools and a programme~     educational on hand hygiene. The investigators hypothesize that the use de hand sanitizers in~     elementary school will reduce absenteeism due to upper respiratory infections.~   "
140516|NCT01728077|"~     N01372 study is to evaluate the long-term safety, tolerability, maintenance of efficacy of~     Brivaracetam (BRV); as well as the effect of BRV on subjects' health-related quality of life~     and to explore the direct medical resource use for BRV (for subjects entering N01372 from a~     study where pharmacoeconomic data was collected). BRV will be used at doses up to maximum of~     200 mg/day, as adjunctive treatment in subjects aged 16 years or older with Epilepsy.~   "
140517|NCT01728064|"~     The purpose of this study is to examine the effects of EPI-743 on visual function and~     neurologic function in patients with Friedreich's ataxia.~   "
140519|NCT01728038|"~     An estimated 6.6 million parents who smoke visit pediatric emergency departments (PED)~     annually. Up to 50% of these parental smokers are from low-income, racially/ethnically~     diverse households in which a variety of tobacco-related disparities (TRD) exist for both the~     parents and their children. The PED is an ideal setting in which to address these~     disparities, which include differences in tobacco use, pediatric second hand smoke exposure~     (SHSe), quit rates, access to cessation resources, and morbidity such as cancer. The team has~     conducted the only two small-scale randomized control trials (RCTs) investigating the~     efficacy of providing smoking cessation counseling to parents in the PED setting. This~     previous research indicates that parental smokers who visit the PED are aware of the~     pediatric effects of SHSe, motivated to quit, eager to receive cessation counseling in this~     setting, and show trends towards quitting.~      Parents with children who have a SHSe-related illness will have higher prolonged abstinence~     and point prevalence cessation rates, higher motivation to quit, greater number of quit~     attempts, and lower child SHSe compared to those parents who have a child with a~     non-SHSe-related illness at baseline.~   "
140520|NCT01728025|"~     The purpose of this study is to determine whether ranolazine will reduce the risk of~     arrhythmic events in patients with long QT syndrome type 3.~   "
140521|NCT01728012|"~     Mineral metabolism disturbances occur early during the course of chronic kidney disease and~     eventually affect most patients. For how long such disturbances persist after a successful~     renal transplantation is mainly unknown. This study will investigate the prevalence of such~     disturbances in patients more than 10 years following a successful renal transplantation. The~     patients will be recruited from an existing registry in Norway.~   "
140522|NCT01727999|"~     Introduction:~      Ineffective platelet production has been proven to play a role in the etiology of Immune~     Thrombocytopenia (ITP) in addition to increased platelet destruction. The second-generation~     thrombopoietin (TPO) mimetics have shown good efficacy in boosting platelet counts in the~     great majority of patients with chronic ITP in several clinical trials.1, 2 Nevertheless,~     about 20% of patients with ITP fail to respond to the TPO mimetic treatment. Those~     treatment-resistant patients are un-characterized and the reasons for the lack of response~     have not been studied. The identification of predictive blood biomarkers of patients'~     response to treatment will be useful in reducing both cost and potential side effects; and it~     will be of equal importance and interest to investigate the molecular mechanisms underlying~     the patients' heterogeneous responses to TPO mimetic treatment.~      Specific Aims:~        1. To identify blood classifier genes which correlate with patients' response to TPO~          mimetic treatment.~        2. To compare the blood gene expression changes in responders and non-responders after TPO~          mimetic treatment and explore the possible molecular mechanisms accounting for the~          non-responsiveness to the treatment.~   "
140523|NCT01727986|"~     This long-term, open-label extension study will evaluate the safety of RoActemra/Actemra~     (tocilizumab) in patients with polyarticular-course juvenile idiopathic arthritis who~     completed the WA19977 core study. Patients aged 9-18 years with at least JIA ACR30 clinical~     response to RoActemra/Actemra in the core study will be eligible to receive RoActemra/Actemra~     8 mg/kg intravenously every 4 weeks. Anticipated time on study treatment is 104 weeks.~   "
140524|NCT01727973|"~     The aim of this study is to evaluate the effects of subantimicrobial dose doxycycline (50~     mg/d), administered for 12 wk, for patients with active moderate-severe Graves' Orbitopathy~     (GO).~   "
140525|NCT01727960|"~     Neck and shoulder pain (NSP) is fairly common among high school students in Korea.~     Presumably, the high prevalence of NSP in Korean adolescents is a consequence of an~     inappropriate static position for a prolonged period of time. We suspect that proper~     education and posture correction for Korean adolescents may decrease the prevalence or~     severity of NSP. Although several studies have focused on the etiology of NSP during~     adolescence, few studies have addressed the management or prevention of NSP in adolescents,~     despite its high prevalence in this age group. The aims of this prospective study was to~     identify the effects of education, in terms of recognition of this issue and posture~     correction, on prevalence and severity of NSP in Korean adolescents~   "
140526|NCT01727947|"~     Current research on sperm morphology has been directed towards the dysmorphisms of the sperm~     head. A new technique based on the motile sperm organelle morphology examination (MSOME)~     allows the detection of sperm with large nuclear vacuoles (SLV). Large nuclear vacuoles are~     specific sperm alterations observed under high magnification, and their presence has been~     related to increased DNA fragmentation and denaturation.~   "
140527|NCT01727934|"~     The purpose of this open-label study is to assess the safety, antiviral activity, and~     pharmacokinetics of 9 subcutaneous injections of miravirsen monotherapy (5 weekly doses over~     5 weeks, followed by a further 4 doses once every other week over 7 weeks) over a total of 12~     weeks of treatment. The subjects enrolled in this study are chronically infected with HCV~     genotype 1 and are null responders to treatment with peg IFNα/RBV therapy.~   "
140528|NCT01727921|"~     Background:~      EUS-guided fine needle aspiration (FNA) is a major diagnostic tool in the patient with~     pancreatic mass with high specificity, specificity and accuracy. However FNA with small~     needle has sometimes failed in acquisition of tissue due to small caliber. To overcome this~     limitation, newly designed ProCore needle was developed and flexible 22 and 25 gauge ProCore~     needles were frequently used. However there was no comparative study of the efficacy and~     accuracy between 22 and 25 gauge ProCore needle yet.~      Aim:~      To compare the efficacy and accuracy of EUS-guided FNA between 22 and 25 gauge ProCore~     needle. (The investigators hypothesized that the accuracy of 25 gauge Procore needle is not~     inferior to 22 gauge ProCore needle.)~   "
140529|NCT01727908|"~     The purpose of this study is to determine whether staining of the gastric mucosa increases~     the number of detected (pre)malignant foci of intestinal and diffuse type gastric cancer, in~     first degree relatives of individuals with familial gastric cancer.~   "
140530|NCT01727895|"~     The purpose of this study is to test wether orally administered Beta-glucan has systemic~     effects in humans.~   "
140531|NCT01727882|"~     The purpose of this study is to investigate whether automated telephony may be used for daily~     assessments of paroled offenders, and whether a brief intervention based on these daily~     assessments may result in a more positive development compared to daily assessments only.~   "
140532|NCT01727869|"~     This is an open-label, multicenter, ascending multiple dose study of REGN1400 alone and in~     combination with erlotinib or cetuximab administered to patients with certain types of~     cancer.~   "
140534|NCT01727843|"~     Tranexamic acid (TA) is a synthetic antifibrinolytic agent. It prevents degradation of fibrin~     and delays the breakdown of hemostatic clots. It has been demonstrated in multiple studies~     and meta analyses to decrease blood loss in elective hip and knee arthroplasty. However,~     concerns about the prothrombotic side effects of systemic administration of TA has hindered~     the widespread adoption of this medication in orthopaedic patients due to their high risk for~     thrombotic complications such as deep venous thrombosis and pulmonary embolism Topical~     application of tranexamic acid has been proposed as a way to mitigate the potential~     prothrombotic effects of TA. Topical application of TA has been demonstrated to be beneficial~     in oral and cardiac surgery. Plasma levels of TA have been found to be minimal following~     topical application, minimizing its potential systemic thromboembolic side effects. TA has~     been used topically in total knee arthroplasty, with significant reductions in blood loss and~     no increase in thromboembolic complications8,10. Data on the use of TA in hip fracture~     surgery is limited, and there are no studies examining topical use of TA in hip fracture~     surgery. Our study question is: Does topical tranexamic acid decrease blood loss following~     hemiarthroplasty of the hip for femoral neck fractures?~   "
140535|NCT01727830|"~     Aim of this in vitro trial is to assess the effect on blood coagulation after 60 % dilution~     with different colloids (HES 130/0.42, Gelatin and Gelatin balanced) and investigate~     reversibility by replacement of fibrinogen (FBG), factor XIII (F XIII), and the combination~     of FBG and FXIII.~      In blood of 12 volunteers the following measurements are performed at baseline and 60%~     dilution with HES 130/0.42, Gelatin or Gelatin balanced: Blood gas analyses, coagulation~     factor concentrations (F II,F VII,F VIII,F XIII), impedance aggregometry and rotational~     thrombelastometry (ROTEM®). Then FBG, F XIII and a combination of both was added, in~     concentrations corresponding to 6 g FBG and 1250 IU F XIII in adults. ROTEM® measurements and~     determination of factor concentrations are again performed.~        -  Trial with medical device~   "
140536|NCT01727817|"~     An unblinded, randomized, cross-over design with each patient participating in two 40-hour~     outpatient admissions: (a) Experimental involving automated Control to Range (CTR) and (b)~     Control using Continuous Glucose Monitor (CGM)- augmented insulin pump treatment outside of a~     hospital based clinical research center.~   "
140537|NCT01727804|"~     The aim of this controlled clinical study was to evaluate the Nd:YAG laser, with or without~     fluoride, in prevention of occlusal caries in the primary dentition.~   "
140538|NCT01727791|"~     This is a pharmacokinetic study to determine the safety and tolerability of pregabalin in~     healthy lactating women. The objectives are to determine whether pregabalin is secreted in~     breast milk and if so, to characterize pregabalin pharmacokinetics in breast milk. Other~     objectives are to estimate potential infant exposure to pregabalin if administered to~     lactating women and to characterize the safety and tolerability of pregabalin in lactating~     women.~   "
140539|NCT01727778|"~     Primary~      - To evaluate the safety and tolerability of escalating doses of an intravenous (i.v.)~     infusion of PAT-SM6 in subjects with relapsed or refractory multiple myeloma.~      Secondary~        -  To evaluate the efficacy and pharmacodynamics by analysis of serum and urine M protein,~          serum free light chains (FLC) κFLC and λFLC, total immunoglobulins, β2-microglobulin,~          C-reactive protein (CRP), exploratory biomarkers and anti-PAT-SM6 antibodies.~        -  To evaluate the duration of response and the progression free survival.~   "
140540|NCT01727765|"~     This is a pilot study which will assess the feasibility of a follow on main study. This study~     will examine the impact of inspiratory muscle training on quality of life, rescue drug~     medication usage, and other markers of asthma in adult asthmatics in the UK.~   "
140541|NCT01727752|"~     A Randomized, Blinded Comparison of Surgical Intervention with the Coflex® Interspinous~     Implant versus Surgical Decompression for Patients with Intermittent Neurogenic Claudication~     caused by Lumbar Stenosis~   "
140542|NCT01727739|"~     Widening of the single tibial tunnel following ACL surgery with quadrupled hamstrings~     autograft may contribute to failure of the graft and/or present technical challenges~     secondary to bone loss in a revision setting (Getelman, 1999). As such, efforts should be~     made to minimize the incidence and magnitude of tibial tunnel widening without sacrificing~     the biomechanical properties of the graft construct. The purpose of this investigation is to~     examine the tibial tunnel widening relationship between bioabsorbable interference screws~     composed of poly-L-lactic acid (PLLA) alone and composite bioabsorbable interference screws~     composed of poly-L-lactic acid embedded with beta tricalcium phosphate (PLLA+TCP) utilized as~     tibial fixation devices.~      Specifically the study has the following objectives: 1) To quantify the extent of tibial~     tunnel enlargement at 3-, 6- and 12-months post ACL reconstruction with autogenous quadrupled~     hamstring graft; 2) To determine if the incorporation of beta tricalcium phosphate to the~     bioabsorbable interference screw alters the observed magnitude of tunnel widening; 3) To~     hypothesize mechanisms for any observed differences between tibial fixation devices; and 4)~     To correlate tibial tunnel widening with clinical outcome status. It is hypothesized that the~     PLLA+TCP bioabsorbable interference screw will not be associated with a reduction in tibial~     tunnel widening around the implant but rather between the implant and articular surface,~     compared to the PLLA alone screw. It is also hypothesized that there will be no effect of~     observed tunnel widening on clinical outcomes or graft failure rates.~   "
140543|NCT01727726|"~     To compare the efficacy of brexpiprazole (flexible dose) with placebo as adjunctive therapy~     to an assigned open label antidepressant therapy (ADT) in the proposed subject population~     with MDD.~   "
140544|NCT01727713|"~     The goal of the current trial is to determine safety of Once-daily aripiprazole in reducing~     Total Tic Severity in children and adolescents with Tourette's Disorder.~   "
140545|NCT01727700|"~     The goal of the current trial is to determine efficacy and safety of Once-daily aripiprazole~     in reducing Total Tic Severity in children and adolescents with Tourette's Disorder.~   "
140563|NCT01727466|"~     Children with high-functioning autism spectrum disorders (ASD) are at high risk for~     developing significant anxiety symptoms. Cognitive behavior therapies (CBT) are frequently~     used for children with anxiety symptoms with good success. The purpose of the current study~     was to examine the efficacy of a family-focused group CBT program (Facing Your Fears [FYF])~     compared to Treatment As Usual (TAU). Participants were randomized to either active treatment~     or TAU. It was hypothesized that children who completed the active treatment would~     demonstrate improvement in their anxiety symptoms relative to children in TAU.~   "
140546|NCT01727687|"~     As society ages, a large amount of human factors related research has been carried out into~     the subject of the safety of the elderly in their daily lives. However, most research focuses~     on the general elderly population and there is a serious lack of research into elderly~     sufferers of Parkinson's disease (PD), who receive a substantial amount of attention in~     medical circles. In the investigators previous study, the investigators have found that~     patient with PD had decreased ability to cross the road as compared to age/gender matched~     control subjects. Hence, this research proposed several training programs to enhance the~     safety of crossing road, including safe place finding，roadside search，time gap and perception~     of other's intentions. The investigators will compare the parameters of crossing road ability~     before and after training programs in patients with PD and control subjects.~      The results of this research will clarify the correlation between medical scale test~     indicators and movement safety for patients with PD. The effects of training programs will be~     provided for further safety management and design concepts to improve the lives of this~     disease group.~   "
140547|NCT01727674|"~     According to the statistics released by the Department of Health,Executive Yuan in~     2005,depression, cancer and AIDS will become the three main diseases of the 21st century.The~     prevalence of depression is 5.8% for males and 9.5% for women in the worldwide total~     population each year.Depression ranks second next to cardiovascular disease and impacts on~     social and economic burdens.From the perspectives of prevalence,suicide rate,loss of~     workforce,family burden,co-morbidities and health care expenses,the issues related to caring~     for patients with depression should not be overlooked.Communication is often neglected while~     exploring the issues of caring for depressed patients,which can consequently affect their~     family,work performance,social interaction,and even leads to a risk of suicide.Therefore,in~     order to enhance their psychological adjustment and health management,it is particularly~     important to achieve effective communications.~   "
140548|NCT01727661|"~     The purpose of this study is to compare the differences of~        1. cardiopulmonary fitness~        2. lung function~        3. muscular oxygen saturation~        4. quality of life between type 1 diabetes mellitus and healthy adults.~   "
140549|NCT01727648|"~     The findings of this project will contribute to the understanding of a comprehensive probe~     for investigation of the effects of monotherapy versus combination rehabilitation~     intervention after stroke, including the topics of possible underlying mechanisms of motor~     recovery as well as the beneficial and adverse effects of intense rehabilitation therapy,~     prognostic factors of the outcomes, and clinimetric properties of the instruments. The~     overall findings of this project will be significant in the era of knowledge translation and~     guide the development of innovative and effective interventions for individualized stroke~     rehabilitation.~   "
140550|NCT01727635|"~     Aims and objectives: This study aims to examine the effects of the body-mind-spirit group~     therapy on marital close relationships, sleeping quality, depression, quality of life,~     meaning of life, and salivary cortisol levels in metastatic breast cancer survivors and~     partners.~      Methods: The design adopts the randomized controlled trial (RCT). The metastatic breast~     cancer survivors will be recruited from outpatient department of surgical at hospital. The~     partners will be invited to participate in this study through the survivors. The 120 dyad~     survivors and spouse will be randomly assigned into an experimental group or a control group.~     Survivors and spouse partners in an experimental group will receive 2 months time~     body-mind-spirit group therapy while those in a control will receive usual care in the same~     period of time. The outcome measures include Experiences in close relationships scale, Moss~     sleeping scale, Short-form 12 health-related quality of life questionnaires, Meaning of life~     questionnaire, BDI-II depression scale and salivary cortisol levels. Measurement time-points~     include pre intervention, post intervention (after 8 weekly group therapy), & then 3, 6, 12~     months after the end of intervention for the maintenance effect. Univariate analyses will be~     performed to explore the basic characteristics of participants. The hierarchical linear model~     will be used to test the hypothesis the improvement is higher in intervention group than the~     control group in the effects of marital close relationships, sleeping quality, depression,~     meaning of life, quality of life, and salivary cortisol levels in metastatic breast cancer~     survivors and partners.~   "
140551|NCT01727622|"~     The purpose of this study is to determine the value of Arterial Spin Labeling (ASL) MRI, a~     measure of blood flow to the brain, in Mild Cognitive Impairment (MCI) and compare it to~     existing measures. In particular, the investigators will compare ASL MRI to Positron Emission~     Tomography (PET/CT), which measures brain metabolism reflecting how well cells in a patient's~     brain are functioning. In addition, the investigators will assess the relationship of these~     measures to specific protein levels associated with Alzheimer's Disease in the patient's~     cerebrospinal fluid (the fluid that surrounds the brain and spinal cord) obtained by lumbar~     puncture. By comparing the information that is available from these procedures to the~     patient's performance on cognitive tests, the investigators hope to learn which procedures~     most accurately reflect and assist in determination of the potential causes of cognitive~     difficulties that arise with MCI, and thus, which are most useful in the clinical setting. In~     particular, PET scans have been found to be very useful in diagnosis of MCI and Alzheimer's~     Disease, but the investigators want to find out if they can get the same, or better,~     information from an ASL MRI scan, which is less expensive and easier to acquire.~   "
140574|NCT01727310|"~     Left valvular heart disease has become one of the most common heart disease in Western~     countries. This disease evolve over many years and are characterized by a long phase where~     the patient is asymptomatic.~      it is characterized by discomfort LV filling may worsen and lead typically to a pressure~     increase of LV pressure and the left atrium (LA) (1). The onset of symptoms is unpredictable~     and may occur at the stage of diastolic or systolic dysfunction.~      Ventricular dysfunction may be insidious, the goal is to detect early dysfunction, knowing~     that it is often very difficult to know if the patient is actually symptomatic. The onset of~     symptoms sign an intolerance to the increase in LV filling pressures and LA , causing~     pulmonary hypertension .~      Therefore, the study of the level of LV and LA filling pressures , if possible by a~     noninvasive method, would identify patients apparently asymptomatic even though their~     condition is advanced.~      Pressures filling pressures can be explored by two methods:~        -  cardiac catheterization, which is a direct and invasive measurement method~        -  echocardiography, which is an indirect measurement method which has the advantage of~          being non-invasive The goal of this research is to compare the two methods.~   "
140552|NCT01727609|"~     Survival of preterm infants has increased greatly over the years, so a major aim now is to~     improve the long term outlook for these babies and to avoid serious complications. The way~     babies are fed in early life affects short and long-term health and survival.~      Because the bowels of preterm infants have not matured, they cannot digest large volumes of~     milk feeds straight away. Until the gut matures, nutrition is provided by intravenous drip~     while the amount of milk given is gradually increased over time. Increasing the amount of~     milk rapidly may increase the risk of gut complications. Increasing the amount of milk given~     more slowly means that intravenous nutrition is needed for longer; there is an associated~     risk of infection proportional to the time the intravenous line is present in the bloodstream~     of these infants. Despite the importance of milk feeding preterm infants, there have been few~     studies to inform how best to balance these risks, and what the best way to increase feeds in~     these infants is - this study sets out to address this missing information.~      The study will compare two different speeds of milk feed increase, one 'faster' and one~     'slower', both within rates currently used in United Kingdom neonatal units. The study aims~     to find out if either speed of milk feed increase gives better outcomes for the infants.~     Investigators will measure a variety of outcomes, such as survival without disability,~     infection, bowel problems, growth and long-term physical and mental development, as well as~     the impact on families and the National Health Service, including costs.~      The study is being led by an established team of researchers who have run similar studies~     before, and uses an established network of neonatal units that have taken part in previous~     studies.~   "
140553|NCT01727596|"~     Background: Taping has been used for more than 20 years for patellofemoral pain syndrome~     (PFPS) but the effectiveness is still controversial.~      Purpose: This prospective study was conducted to investigate the effect and predictors of~     effectiveness of taping in treating PFPS.~      Study design: Prospective cohort study Methods: One hundred consecutive patients with the~     diagnosis of PFPS were included in the study. Factors including sex, age, body mass index~     (BMI), Q angle, lateral patella displacement (LPD), lateral patellofemoral angle (LPA) and~     pre-taping pain score were measured. One well-trained therapist applied adhesive tape to each~     patient by McConnell approach. Before and after taping, patients completed a visual analog~     pain scale (VAS) after performing a step-down from an 8-inch platform. Paired-t test was used~     for the difference of the VAS score measured before and after taping. Patients with~     improvement of more than 1 point in VAS score after taping were considered responsible, and~     others were non-responsible. The results were analyzed by logistic regression.~   "
140554|NCT01727583|"~     This pilot study is aimed at assessing the acute effect of several combinations of lipids~     differing in their fatty acid composition on glucagon-like-peptide (GLP)-2 and GLP-1~     secretion in healthy subjects.~   "
140555|NCT01727570|"~     To determine the impact of nutritional supplementation with whey protein on postoperative~     functional capacity in patients undergoing colorectal surgery for cancer.It is hypothesized~     that, compared with a control group receiving nutrition counselling only, patients receiving~     nutritional counselling along with preoperative and postoperative nutritional supplements~     will have a significantly improved change in functional walking capacity from baseline to 8~     weeks after surgery.~   "
140556|NCT01727557|"~     This study is being done to compare the two anesthesia techniques which are commonly used in~     the formation of arteriovenous fistulas: local anesthesia and regional anesthesia. Local~     anesthesia means that, your doctor will inject numbing medication directly into the tissue or~     part of your body where the surgery will be done. In this case, the numbing medication will~     be injected directly into the area where your fistula will be made. In regional anesthesia,~     the numbing medication will be injected around the nerve (part of the body that gives~     sensation) for your arm, to make the entire arm numb. The purpose of this study is to compare~     the three month success rates of AV fistulae created by the two anesthesia techniques.~   "
140557|NCT01727544|"~     The primary objective of this study is to measure objective, functional outcomes of patients~     undergoing cartilage cap occlusion surgery for a dehiscent superior semicircular canal.~   "
140558|NCT01727531|"~     This research is being done to determine if a short course of Chloroquine (five weeks)~     before, during and after whole brain radiation therapy (WBRT) will improve the overall~     survival of subjects being treated for brain metastases.~   "
140559|NCT01727518|"~     The Austrian LEAD study is the first investigation initiated in Austria that aims to~     investigate the prevalence and the natural history of COPD in a reference population of~     Austria.~   "
140560|NCT01727505|"~     Preterm infants undergoing mechanical ventilation often present with respiratory instability~     which leads to fluctuations in ventilation and oxygenation. In conventional modes of~     mechanical ventilation used in these patients, the ventilator delivers breaths at a set rate~     and a constant peak inspiratory pressure.~      We have demonstrated that spontaneous episodes of hypoxemia in mechanically ventilated~     preterm infants are frequently triggered by a loss in end-expiratory lung volume followed by~     decrease in tidal volume. This is due to a reduction in respiratory system compliance and~     increase in airway resistance.~      Volume Guarantee ventilation is a mode of ventilation in which ventilator measures the~     exhaled tidal volume of each ventilator breath and automatically adjusts the peak inspiratory~     pressure to deliver the set tidal volume. We have previously shown that Volume Guarantee~     reduced the severity and duration of hypoxemia episodes during a period of 2 hours in preterm~     infants The study hypothesis is that Volume Guarantee ventilation will decrease the duration~     of episodes of hypoxemia when compared to conventional mechanical ventilation during routine~     clinical conditions and over longer periods of time.~      The objective of the study is to evaluate the effects of Volume Guarantee on the duration,~     severity and frequency of episodes of hypoxemia in mechanically ventilated preterm infants~     who present with frequent hypoxemia episodes in comparison to conventional ventilation over~     two periods of 24 hours each and under routine clinical conditions.~   "
140561|NCT01727492|"~     The current study is a dubble-blinde placebo-controlled cross-over study verifying the~     preventive effect of antioxidants on noise-induced hearing loss (NIHL) and noise-induced~     tinnitus (NIT). The antioxidants comprise of a mixture of magnesium and n-acetylcystein which~     should be taken 1h before leisure noise above 100dB for at least 30 minutes.~   "
140562|NCT01727479|"~     Investigate the acute effect of ribose supplementation on performance and recovery in~     athletes.~   "
140564|NCT01727453|"~     SUMMARY~      1.0. Type of Application: Clinical trial comparing two treatments in terms of authorized use.~      1.1. Promoter: Institute of Research, Hospital de la Santa Creu i Sant Pau. Avgda. Sant~     Antoni M.Claret, 167. 08025 Barcelona. Tel: (34) 93 291 9140/93 291 21 73.~      1.2. Title: Randomized controlled trial to compare treatment with oral anticoagulation with~     antagonists of vitamin K versus low molecular weight heparin (Bemiparin) in patients with~     anticoagulation criteria and who have had an episode of gastrointestinal bleeding.~      1.3. Protocol code: HEPACO 1.4. Principal Investigators: Dr. Candid Villanueva Sanchez. Dr.~     Jose Mateo Arranz. Contributors: Dr. Alicia Brotons (Service of Digestive Pathology), Dr.~     Angela Puente (service of Digestive Pathology), Dr. Isabel Graupera (Service of Digestive~     Pathology) and Dr. Marina Carrasco (Hematology Service). Hospital de la Santa Creu i Sant~     Pau. Avgda. Sant Antoni Maria Claret, 167. 08025 Barcelona. Tel: (34) 93 291 91 39. Fax: (34)~     93 291 92 78.~      E-mail: cvillanueva@santpau.es. 1.5. Centers that are planned for the trial: Service~     Gastroenterology and Hematology Service of the Sant Creu i Sant Pau, Barcelona.~      1.6. Clinical Research Ethics Committee: Hospital de la Santa Creu i Sant Pau. 1.7. Monitor:~     Institute for Research (CAIBER) of the Hospital de Sant Pau. Avgda. Sant Antoni M.Claret,~     167. 08025 Barcelona. Tel: (34) 93 291 9140.~      1.8. Drugs: warfarin, bemiparin. 1.9. Development stage: Clinical Trial phase IV 1.10. Main~     objective: To compare the incidence of gastrointestinal rebleeding and safety of oral~     anticoagulation versus low molecular weight heparin in patients who have had an acute~     gastrointestinal bleeding and have indication for anticoagulation.~      1.11. Design: prospective open clinical trial, randomized and controlled. 1.12. Study~     disease: acute gastrointestinal bleeding. 1.13. Primary endpoint of the valoration: Incidence~     of gastrointestinal bleeding.~      1.14. Study population and total number of patients: 20 patients were required in each group~     (40 total) to objectify a decrease of rebleeding rate of 45% with an alpha error of 5% and~     10% beta.~      1.15. Treatment duration: 2 years. 1.16. Calendar and expected completion date: July 2011 -~     July 2013~   "
140565|NCT01727440|"~     The goal of this study is to enroll 250 participants that have joined the MURDOCK Study~     Horizon 1.5 (Duke IRB Pro00011196) with a current or prior diagnosis of severe acne AND~     current or prior treatment with oral isotretinoin. All 250 participants will answer a 5-page~     questionnaire designed to collect information on the diagnosis of severe acne and response to~     oral isotretinoin treatment. The aim is to identify genetic predictors of severe acne~     vulgaris and the outcome of oral isotretinoin treatment.~   "
140566|NCT01727427|"~     The same initial and long-term anticoagulation is suggested for unsuspected pulmonary~     embolism as for patients with symptomatic embolism. Based on these indications, cancer~     patients with unsuspected pulmonary embolism would be anticoagulated for at least 6 months or~     until the disease is active, which in most cases would mean indefinite treatment. In fact,~     dedicated studies on the treatment of unsuspected pulmonary embolism are missing, leaving~     doubts over the need for (indefinite) anticoagulation which exposes these patients to an~     increased risk of major bleeding events. Concerns over the need for anticoagulant treatment~     may especially hold for pulmonary embolism of the distal pulmonary tree since segmental and~     sub-segmental PE seem to have a more benign course than more proximal embolism.~      The scope of this study is to evaluate the current treatment approaches for unsuspected~     pulmonary embolism and to assess their efficacy and safety in a large prospective cohort of~     cancer patients.~   "
140567|NCT01727414|"~     This study evaluates how children with Attention Deficit Disorder without Hyperactivity (ADD)~     respond to medication, and if their response is different from children who have problems~     with both hyperactivity and inattention. In order to do this, children ages 7-11 whose~     primary difficulty is with attention problems and who have never been on behavioral or~     psychiatric medications are being recruited. Once enrolled, children will try one week each~     of 3 different doses of methylphenidate, the most commonly prescribed Attention Deficit,~     Hyperactivity Disorder (ADHD) medication, as well as placebo. Children will be randomly~     assigned to one of six possible medication dose and placebo titration schedules, but the~     study doctor, family, and teacher will not know which dose (if any) children are receiving~     for a given week. Each week, behavioral and side effect ratings will be completed by both the~     child's parent and teacher, and the family will meet with the study doctor for a physical~     examination and to discuss how each week went. Some children will also have~     neuropsychological testing to determine how methylphenidate influences their working memory,~     sustained attention, and ability to inhibit (stop) inappropriate responses.~      All data will be analyzed to decide which medication dose the child responded to best and~     further recommendations for treatment will be given. Ultimately, this study aims to improve~     understanding of how children with ADHD-Primarily Inattentive Type respond to stimulant~     medications by~        -  determining whether these children experience a diminished response to methylphenidate~          compared to children with both hyperactivity and inattention~        -  determining whether certain genetic and environmental factors play a role in this~          response.~      Findings from this study will be used to help streamline the identification of the most~     effective doses of medication for children with ADHD-Primarily Inattentive Type.~   "
140568|NCT01727401|"~     Fondaparinux is a parenteral anticoagulant drug approved for the prophylaxis of venous~     thromboembolism in high risk medical patients. A relevant proportion of these patients have~     renal insufficiency and/or thrombocytopenia which represent independent risk factors for~     bleeding. The risk of bleeding may be increased when fondaparinux is administered to patients~     with a reduced renal function and/or low platelet count. A lower dose of fondaparinux, 1.5 mg~     daily, has been approved for patients with renal insufficiency defined by a creatinine~     clearance between 20 and 50 mL/min. However, to our knowledge, there are no clinical studies~     that have specifically evaluated prophylaxis with fondaparinux in acutely-ill medical~     patients with a moderate to severe thrombocytopenia. The scope of this study is to evaluate~     the safety of fondaparinux in high risk hospitalized medical patients with a moderate to~     severe thrombocytopeniada defined by a platelet count between 100,000/uL and 30,000/uL.~   "
140569|NCT01727388|"~     Digital rectal examination is an act clinically performed daily by physicians and surgeons.~     It remains the key diagnostic test and directs the therapeutic management of cancer of the~     lower and middle rectum. It can be done in two main positions: lateral decubitus, and supine.~      However, no randomized study in colorectal surgery is not interested in evaluating the best~     position to perform a full rectal exam.~   "
140570|NCT01727375|"~     The purpose of this multicenter randomised controlled trial is to investigate if circadian~     light at the patients bedside (using Philips HealWell system, CE marked)significantly reduces~     prevalence of delirium in mechanically ventilated intensive care unit patients.~   "
140571|NCT01727362|"~     The aim of this trial is to investigate the effectiveness of acupuncture on quality of life~     in patients with breast cancer receiving chemotherapy compared to routine care.~   "
140572|NCT01727349|"~     Considering its epidemic-like development worldwide, associated with modifications in~     lifestyle, as well as its enormous social and economic weight, the prevention of type II~     diabetes is certain to be a central concern of health systems within the developed countries~     in the decades to come. However, while simple obesity concerns the entire population, type 2~     diabetes affects only one sub-population at high genetic risk. To be effective and realistic~     in economic terms, efforts at prevention must be thus targeted towards these subjects at high~     risk. The key issue involves identifying such subjects early enough so that a strategy of~     effective prevention can be organized in good time.~      Until now, efforts have been concentrated on individuals at risk for diabetes readily~     identifiable within the general population, typically subjects in the second half of~     adulthood, presenting abdominal obesity and mild abnormalities of blood sugar. Preventive~     lifestyle and dietary measures are proposed but are constrictive and difficult to maintain~     over time, and the results, although they may be significant, remain disappointing, with mere~     postponement of an outcome which at this stage appears inevitable. The reason is ascribable~     to excessively tardy intervention, when the pathogenic process has already been ongoing for~     some ten years and the endocrine function of the pancreas is probably already irreparably~     impaired.~      The alternative thus is earlier intervention, in childhood, adolescence or early adulthood.~     The problem is to identify individuals at high risk of becoming diabetic at a time when they~     are presenting no simple clinical or laboratory abnormalities allowing easy diagnosis. The~     familial character of type 2 diabetes is now well established, and future diabetic subjects~     are themselves above all the children of diabetic subjects. However, the prevalence of the~     disease among the descendants of type 2 diabetic subjects is around 20-30% and predictive~     tools are needed to combat diabetes in these high-risk families.~      We propose to create a risk equation using an algorithm to reliably predict children most~     likely to develop diabetes later in life.~      The algorithm will include 3 classes of data:~        -  The genotype stemming from the genetic characterization of individuals and those their~          parents;~        -  Environmental data concerning childhood, especially eating habits and physical activity;~        -  Data of the mother who was eventually diabetic during pregnancy.~      From a methodological standpoint, it would be rather difficult to take blood samples from~     children and wait some 50 years to determine whether or not they develop diabetes. To~     circumvent this difficulty, we will recruit subjects in families with a history of type II~     diabetes:~        -  Parents alive, including at least one type 2 diabetic subject~        -  Adult children (aged over 35 years), some of whom are already presenting type II~          diabetes, and healthy brothers and sisters, who form the control population. Test will~          be done to determine whether healthy subjects are really safe from the risk of diabetes~          (HbA1c measurement and glucose load test).~      The Descendence study will include 500 families at risk involving about 3000 subjects (1000~     subjects with diabetes and 2000 healthy subjects). It is expected to answer the following~     question: for a child born in such families at risk, what is the probability of developing~     diabetes later in life, so that early preventive action may be taken~   "
140573|NCT01727336|"~     The purpose of Part 1 of this study is to evaluate the safety and tolerability of~     dalantercept in combination with axitinib in patients with advanced renal cell carcinoma~     (RCC) to determine the recommended dose level of dalantercept in combination with axitinib~     for Part 2.~      The purpose of Part 2 of this study is to determine whether treatment with dalantercept in~     combination with axitinib prolongs progression free survival (PFS) compared to axitinib alone~     in patients with advanced renal cell carcinoma (RCC).~   "
140575|NCT01727297|"~     This study is to determine, through continuous monitoring with the Reveal implantable cardiac~     monitor (ICM), the incidence of atrial fibrillation (AF) in patients suspected to be at high~     risk for having AF and to understand how physicians manage these patients after AF has been~     detected. This study will also seek to identify what patient characteristics are most~     predictive of developing AF.~   "
140576|NCT01727284|"~     The purpose of this research is to see if MR-guided cryoablation can effectively treat~     prostate tumor recurrences.~   "
140577|NCT01727271|"~     This study will compare monotherapy with tenofovir to sequential therapy with pegylated~     interferon alpha-2b (pegIFN-2b) followed by tenofovir, and to combination therapy with~     pegIFN-2b + tenofovir, in participants with hepatitis B e antigen (HBeAg)-positive chronic~     hepatitis B and elevated alanine aminotransferase (ALT). All enrolled participants will be be~     administered tenofovir alone for 8 weeks and then will be randomly assigned to 1 of the 3~     treatment arms.~   "
140578|NCT01727258|"~     This study is for people with sensitive teeth and involves going to the dentist for 4 visits~     over 6 weeks. At each visit the dentist will look at the mouth, teeth, tongue and gums of~     subjects, and check for sensitive teeth.~      During the first 2 weeks, participants will brush their teeth two times a day with the~     fluoride toothpaste provided.~      Then, if they qualify to continue in the study, participants will be assigned to a treatment~     group. All the groups will get toothpaste currently sold on the market, and one group will~     get a mouthwash with an experimental ingredient to use as well. Subjects will have an equal~     chance of being assigned to any one of the three groups.~      For the next 4 weeks, subjects will use their assigned products according to the directions~     provided. At Visit 1 subjects will be supervised while they brush their teeth to ensure they~     understand the directions. They will also have supervised use of the product at Visit 2.~      We will see if the mouthwash helps to reduce tooth sensitivity during the study.~   "
140579|NCT01727245|"~     We want to asses the role of adipose tissue for metabolic complications to obesity before and~     after weight loss (surgery).~   "
140580|NCT01727232|"~     The aim of this large French multicentric retrospective study was to compare the efficacy and~     safety of two (the standard and the Rheumatoid arthritis) rituximab regimens in adult's~     immune thrombocytopenia .~   "
140581|NCT01727219|"~     The frequency of depression in COPD patients are substantial and early detection and~     prevention of depression is critical.~      Recently, COPD assessment test (CAT) was developed and validated to assess the impact of COPD~     on patients' quality of life.~      In this prospective study, we will investigate the predictive utility of CAT for predicting~     depression in COPD patients.~   "
140582|NCT01727206|"~     The study we propose is a pilot phase II, interventional, treatment, open-label, single-arm,~     efficacy/safety clinical trial of a 6-month treatment with tocilizumab (8 mg/kg once monthly)~     in adult patients with extraskeletal Erdheim-Chester disease (ECD). Efficacy will be assessed~     as the effect of the treatment on the size of the measurable lesions, as evaluated by~     bidimensional measurements, and by the impact of the treatment on symptom control and on~     patient quality of life. Safety of the treatment will be determined by the analysis of~     adverse events and of the relevant safety laboratory parameters.~      Secondary objectives of the study will be:~        1. to better characterize the mechanisms underlying such disease and the possible response~          to the treatment. In particular: i) we will investigate the immunophenotypic and~          histomorphologic features of ECD histiocytes; ii) we will gather gene expression data~          from peripheral blood immune cells to better characterize their functional status, to~          define their transcriptional fingerprints and their possible modulation as a result of~          tocilizumab treatment; iii) we will assess the production of soluble mediators and the~          expression of activation molecules by monocytes derived from ECD patients, as well as~          after stimulation with selected inflammatory cytokines; iv) we will investigate the ex~          vivo and in vitro impact of tocilizumab treatment on those markers, for possible use as~          a predictor or indicator of response to treatment.~        2. to investigate the metabolic pattern in ECD patients before and after tocilizumab~          treatment as evaluated by fluoro-d-glucose positron emission tomography (FDG-PET) and to~          verify if it can be an indicator of ECD activity.~   "
140583|NCT01727193|"~     This is a randomized controlled clinical study. The investigators screen of eligible~     patients, randomized divide into the following two groups: corticosteroids + azathioprine~     group, corticosteroids + leflunomide group. The investigators treat the enrolled patients,~     estimate efficacy and observed the side effects according to the requirements of program. The~     investigators establish a clinical database for recording patients date and statistical~     analysis. Evaluation of short-term and long-term efficacy of thymectomized myasthenia gravis~     patients in the different group prove that what kind of treatment can improve the cure rate.~     The investigators will evaluate the acute toxicity (gastrointestinal side effects, liver and~     kidney dysfunction) and long-term toxicity (immune dysfunction, gonadal suppression) when the~     investigators apply these therapy in the treatment of different clinical types of MG.~   "
140584|NCT01727180|"~     We believe that knowing characteristics of uremic pruritus is the foundation to investigate~     its pathophysiology and offer better skin care for patients with chronic kidney disease. We~     therefore conducted this cross-sectional study to evaluate the characteristics of uraemic~     pruritus.~   "
140585|NCT01727167|"~     This study will test if inhalation of Carbon Monoxide (CO) will increase the numbers of~     mitochondria in heart muscle. Mitochondria are the small components of muscle and other cells~     that convert fuel and oxygen to the easily usable forms of energy (ATP) that power all cell's~     activities. Adequate numbers of healthy mitochondria are essential to heart cell function.~     From animal and other studies we have reason to believe that breathing small amounts of CO~     will signal the body to increase the numbers of mitochondria in heart cells. We propose to~     test this theory in heart valve surgery patients by examining a small sample of heart tissue~     (from the right atrial appendage) that is routinely cut out during the preparation of the~     patient for cardio-pulmonary bypass and that would otherwise be discarded by the surgeon.~     Muscle samples from two groups of subjects will be compared. One group will breath CO and the~     other group will breath room air. If CO is effective, we should notice an increase in the~     numbers of mitochondria in the group that was exposed to CO compared to the group that~     breathed room air.~   "
140586|NCT01727154|"~     The purpose of this study is to evaluate the immune response induced by sipuleucel-T~     (Provenge®).~   "
140587|NCT01727141|"~     This study will assess the efficacy, safety and tolerability of QVA149 in patients with~     moderate to severe airflow limitation.~   "
140588|NCT01727128|"~     To assess pharamcokinetics, safety and tolerability of a single oral dose of BKM120 in~     subjects with mild, moderate and severe hepatic impairment~   "
140589|NCT01727115|"~     The primary objective of this study is to demonstrate that ALTHERA® is equal or superior in~     efficacy than NUTRAMIGEN®~   "
140591|NCT01727076|"~     This phase I trial studies the side effects and best dose of recombinant interleukin-15 in~     treating patients with melanoma, kidney cancer, non-small cell lung cancer, or head and neck~     cancer that has spread to other places in the body and usually cannot be cured or controlled~     with treatment. Recombinant interleukin-(IL)15 is a biological product, a protein, made~     naturally in the body and when made in the laboratory may help stimulate the immune system in~     different ways and stop tumor cells from growing.~   "
140592|NCT01727063|"~     Patients with advanced coronary artery disease usually undergo incomplete myocardial~     revascularization due to the extension and diffuseness of the disease, with very poor distal~     arterial beds unsuitable for direct revascularization.~      This study was designed to test the hypothesis that direct, intramyocardial injection of~     autologous bone marrow cells may further improve myocardial perfusion in patients undergoing~     incomplete bypass surgery.~   "
140593|NCT01727050|"~     Laparoscopic totally extraperitoneal hernioplasty (TEP) is one of the treatment options for~     the repair of primary unilateral inguinal hernia. Previous studies showed that patients~     underwent TEP have less post-operative pain and earlier return to normal activities. However,~     chronic pain is still a major issue affecting quality of life after TEP with a reported~     incidence of 9.2-22.5%. Mechanical stapling is the most commonly used method of mesh fixation~     to prevent mesh migration but nerve entrapment by staples causing intractable pain had been~     reported. Recently several clinical trials showed that mesh fixation with fibrin sealant (FS)~     in TEP resulted in less chronic pain but increased incidence of seroma. A spraying device for~     application of FS laparoscopically is now available which can achieve mesh fixation by using~     fewer amounts of FS.~      In this study, the investigators aim to compare the effectiveness of using fibrin spray for~     mesh fixation in reducing chronic pain after TEP. The investigators performed a randomized~     controlled trial by allocating patients in two study arm in random manner. The treatment~     group will have the mesh fixed by fibrin sealant spray, whereas the control group will have~     conventional mechanical staples for fixation. Operative procedures and post-operative~     management for the 2 groups will be identical. They will be follow-up at 1-month and 6-month~     after operation to evaluate the operative results and the incidence of chronic pain. Any~     complications related to the mesh and operation will also be recorded.~   "
140594|NCT01727037|"~     Patients with large bullae (large empty air sacs in the lung) may benefit from bullectomy~     (surgery to resect these bullae), however this is a major surgery with significant potential~     morbidity and long hospital stays. Many patients are not well enough to have this surgery, or~     may not wish to have it. A less invasive means of attempting to shrink the size of the bullae~     is to directly inject the patients' own blood into the bullae (we believe that this can lead~     to an inflammatory reaction leading to gradual scarring and volume loss). This can be~     performed bronchoscopically in a 20-30 minute procedure using conscious sedation (avoiding~     general anaesthesia).~      The aim of this study is to assess the effects on lung function, quality of life measures,~     functional measures and CT measured lung volumes of bronchoscopic intrabullous blood~     instillation in patients with bullous emphysema.~   "
140595|NCT01727024|"~     This study compared the correct use of and patient preference for two drug delivery systems~     (inhalers) in patients with COPD~   "
140596|NCT01727011|"~     Irradiation and Accelerated Partial Breast (IPAS) to this day remains a therapeutic concept~     whose validity is being assessed on its non-inferiority in terms of local control compared to~     whole breast irradiation. At least eight phase III trials attempting to answer this question~     and thus provide a sufficient level of evidence to make this concept a new standard of care~     for sub-groups of patients well defined (1).~      However, without waiting for the final results of these randomized trials (which will not be~     fully valid with a drop of at least ten years), the American societies (ASTRO) and European~     (ESTRO) radiotherapy have all two proposed classification (very similar) into 3 groups~     according to the risk to the patient in terms of local recurrence after IPAS. And are defined~     by the ESTRO:~        -  The low-risk group (suitable for ASTRO)~        -  The intermediate-risk group (cautionary in ASTRO)~        -  The high-risk group (not suitable for ASTRO) (2.3). Therefore, it is possible to~          propose to a patient a randomized clinical tria IPAS, to subject it belongs to the group~          low risk. The results of phase II trials as a long-term analysis of the matched team~          of William Beaumont Hospital (4) and the phase III trial using intra-operative radiation~          photons in low energy X whose results were recently published (5) confirm the value of~          this new therapeutic concept for post-operative breast cancer at low risk of local~          recurrence.~      In France, the therapists were quickly directed to a sub-population for which the IPAS could~     represent a real improvement in the therapeutic management in significantly reducing the~     number of irradiation sessions of thirty in 6 weeks 5 days at 10 in a single view (6).~     Several French phase II trials were started specifically targeting the female population aged~     using a balloon catheter (MammoSite ®) (7) or by intra-operative radiation électronthérapie~     (8). The results of the test using the GERICO-03 brachytherapy with high dose rate (promoter:~     FNCLCC, National Federation of Anti Cancer Centres , recently merged into Group Health~     Cooperation entitled UNICANCER) are currently submitted to Journal Green Radiotherapy~     (Radiotherapy and Oncology from 09/11/11) (9).~      On a technical level, two main approaches are used (10):~        -  Irradiation intraoperative electron or low-energy photons,~        -  Radiation after surgery The advantage of intraoperative irradiation is the optimal~          reduction of total processing time radio-surgery because the patient is irradiated~          during the lumpectomy. However, 15-20% of these patients receive partial breast~          irradiation, as histo-prognostic criteria provided in the histologically final report,~          confirm the non-adapted indication of IPAS (5).~      In contrast, the post-operative IPAS can treat only patients meeting all criteria for IPAS~     but treatment-related travel are about 5 treatments for bi-fractionated (2 sessions per days~     separated by at least 6 hours).~   "
140597|NCT01726998|"~     The investigators aimed in this study to investigate the effects of 4 weeks robot-assisted~     locomotor training on motor recovery of lower extremities and walking ability compared with~     the conventional gait training in subacute post-stroke non-ambulatory hemiplegic patients.~      72 first-ever stroke patients who could not walk independently (FAC < 2), and suffered within~     6 months were enrolled and randomly assigned into 2 groups. The subjects with congestive~     heart failure, malignancies, cardiopulmonary dysfunctions, and who could not walk~     independently before stroke attack were excluded.~      Two groups received 30 minutes conventional gait training including Neurodevelopmental~     Treatment (NDT) basically. The robotic assisted locomotor training group received additional~     robotic-assisted gait therapy for 30minutes with Lokomat® (Hocoma, Zurich, Switzerland) daily~     for 4 weeks, and the conventional gait training group received additional daily conventional~     gait training with NDT for the same periods. The independent walking ability(FAC ≥ 3),~     Functional Ambulation Category (FAC), Motricity index (MI), Fugl-Meyer assessment (FMA),~     Modified Barthel Index (MBI), Medical Research Council (MRC) for each lower extremity muscles~     were assessed before, during (2weeks) and after training. And the independent walking ability~     were followed until 3 months.~   "
140598|NCT01726985|"~     Heart failure is the leading cause of hospitalizations and readmissions in the United States~     and is a tremendous economic strain on our healthcare system. There is currently, based on~     national averages, a 30% readmission rate and 10% mortality rate within 3 months of being~     hospitalized for heart failure. Retrospective studies have shown benefit to using biomarkers~     such as BNP to guide inpatient heart failure management. Our own CCF retrospective study~     showed that decreasing NT-ProBNP by 23%, making patients fluid negative by more than 1.3L,~     and discharging patients with serum sodium above 135 reduces readmission rates significantly.~     The purpose of this study is to prospectively use the above mentioned goals in the treatment~     of heart failure in order to reduce heart failure readmission and mortality rates.~   "
140599|NCT01726972|"~     The proposed study aims to objectively assess 2-year clinical and radiographic results for~     the rate of glenoid component loosening in total shoulder arthroplasty (TSA). This~     retrospective radiographic review will provide evidence for equivalence or superiority in~     curtailing loosening, a known complication in arthroplasty, when a hemostatic agent is~     utilized in conjunction with cement at the glenoid.~   "
140623|NCT01726660|"~     The purpose of this study is to determine if tailoring multiple sessions of upper extremity~     robotic therapy to focus on a particular aspect of movement (e.g smoothness vs. aiming;~     active range of motion vs. functional practice)can optimize therapeutic results and lead to~     greater functional returns in arm mobility after stroke.~   "
140624|NCT01726647|"~     Objectives:~      The primary objective of this clinical trial is to characterize metabolic signatures~     associated with abdominal fat distribution in 40 women with different BMI 29-40 and different~     abdominal distribution of fat (visceral vs. sub-cutaneous fat).~      No intervention with a product is planned. The subjects will be given one high fat meal with~     commercial products (eggs, milk, cream, bread, fruits, cheese and cheese) on one test day to~     test the post-prandial metabolic response.~   "
140600|NCT01726959|"~     The objective of this study is to identify genetic predictors of individual methotrexate~     (MTX) response in patients with rheumatic diseases by determining genetic and metabolomic~     factors related to nutrient metabolism and drug transport.~      The development of better genetic predictors of individual MTX treatment response would~     provide invaluable prognostic information prior to initiating treatment, which would allow~     more appropriate choice of therapy, decreased adverse events, and more efficient~     dose-escalation of the drug, with ultimate benefits of improved effectiveness and~     tolerability rates in patients being treated with MTX for autoimmune diseases.~      Despite being the gold-standard therapy for rheumatoid arthritis and other types of chronic~     autoimmune diseases since 1951, MTX's efficacy and safety profile limit its use: MTX is~     discontinued in greater than 50% of patients secondary to inefficacy or poor tolerability.~     Upon initial treatment, discontinuation rates approach 12% because of drug toxicity, despite~     prophylactic measures such as the co-administration of folic acid. The causes of primary~     failure, secondary failure, and adverse events of MTX may be related to genetic variation of~     dihydrofolate reductase (DHFR) and other genes involved in folate metabolism, one-carbon~     transfer, and drug transport. The purpose of this study is to identify genetic variations~     involved in methotrexate response so that we may better understand the pharmacodynamics of~     MTX metabolism in patients with rheumatic diseases.~   "
140601|NCT01726946|"~     A Phase 2 study to evaluate the safety and efficacy of two different once daily doses VX-135~     in combination with ribavirin in treatment-naïve subjects with chronic hepatitis C~   "
140602|NCT01726933|"~     The aim of the study is to evaluate the efficacy and safety of LAS41008 in comparison to~     active control and placebo in patients with moderate to severe chronic plaque psoriasis~   "
140603|NCT01726920|"~     The purpose of this study is to determine whether a fixed-dose combination of naratriptan 2,5~     mg + naproxen 500 mg is effective and safe compared each monotherapy for the acute treatment~     of migraine.~   "
140604|NCT01726907|"~     Traditional transcervical incision of the upper neck is a safe and effective approach for~     resection of the submandibular gland (SMG). However, external scar at the highly visible area~     may be a burden for the patients and sometimes may lead to disfiguring hypertrophic scar or~     keloid. Recently, the investigators reported our surgical technique of 'endoscope-assisted'~     and 'robot-assisted' SMG resection, which was feasible and showed excellent cosmetic outcomes~     since the scar was hidden by the auricle and hair. In our previous feasibility study of~     robot-assisted SMG resection, the investigators proposed that robot-assisted technique may~     overcome the limitations of endoscopic instruments with rigid and straight nature without~     articulation and surgical view of two-dimension. In addition, the ergonomically designed~     operating system was more convenient for the surgeon considering the frequent collision of~     the endoscopic instruments and reversed hand-eye coordination in endoscope-assisted surgery.~     However, clinical trial comparing the surgical outcomes of the two techniques has not been~     reported in the literature.~      In this study, the investigators made a prospective comparative study of robot-assisted~     versus endoscope-assisted SMG resection to determine whether robot-assisted technique has~     benefits regarding early surgical outcomes.~   "
140605|NCT01726894|"~     To determine the adverse events and genito-urinary side-effect profile of focal therapy to~     treat localised low to intermediate risk prostate cancer using irreversible electroporation~     (Nanoknife™).~   "
140606|NCT01726881|"~     People with a Spinal Cord Injury can develop chronic pain within months of the injury. Up to~     80% of the patients will develop chronic pain called central pain and describe the pain as:~     burning, stabbing, or like electricity. Central pain mechanism is unknown and therefore~     treatment is currently not effective.~      It is hypothesized that chronic pain is associated with impaired function of the systems~     regulating pain, however, this hypothesis has not been tested among Spinal Cord Injury~     patients. Presence of such a connection, between the regulating system dysfunction and~     central pain, will help both predicting the risk of central pain and develop a treatment.~      The current research objective is to make several sensory measurements which will measure the~     functioning mechanisms of regulation and control of the pain. These measurements are accepted~     throughout the world and are based on psychophysical assessment of patients. these~     Measurements are designed to assess whether Spinal Cord Injury chronic central pain patients~     demonstrate impairment in the regulation of pain. Finding such a link between central pain~     and impaired regulation could shed light on the mechanism of central pain. In addition, these~     measurements are designed to assess whether fresh spinal cord injury patients that have not~     yet developed central pain demonstrate impairment in the regulation of pain immediately after~     the injury. By repeated assessments of pain regulation capabilities, which will be made to~     fresh Spinal Cord Injury patients during the first months of injury, and comparing the~     results of these measurements between those who will develop center pain and those who will~     not, we could identify indicators for predicting the risk of central pain. Another goal of~     the study is to investigate the efficacy of central pain treatment, using a TENS, when the~     parameters of the TENS treatment will be built according to the level of functioning of the~     regulating systems of the individual.~   "
140607|NCT01726868|"~     The aim of this study is to evaluate efficacy and safety of blood purification therapy on~     renal dysfunction by cholesterol crystal embolism.~   "
140608|NCT01726855|"~     The purpose of this study was to report a new method of flexor tendon repair in zone II with~     combined standard modified Kessler technique and vascularized finger dorsal fascial flap~     pedicled with dorsal cutaneous branch of proper digital artery ,which is transported to~     finger volar for placement of a mechanical barrier between flexor digitorum superficialis~     /profundus tendons. The function outcomes of 14 patients (Group A) with flexor tendon repair~     in zone II with this new technique were compared with those of 32 patients (Group B) with~     flexor tendon repair in zone II with standard modified Kessler technique. This new technique~     may prevent serious adhesions between flexor digitorum superficialis /profundus tendons.~   "
140609|NCT01726842|"~     The purpose of this project is to compare the performance of the Pediatric Vision Scanner~     (PVS) with the Gold Standard Examination to determine the effectiveness of the PVS at~     detecting amblyopia and strabismus.~   "
140610|NCT01726829|"~     This is a randomized prospective single blind trial to evaluate blood glucose control~     overnight under closed-loop insulin delivery with MD-Logic Artificial Pancreas (MDLAP) system~     in patients with type 1 diabetes, being conducted in: Tel Aviv, Israel, Ljubljana, Slovenia~     and Hannover, Germany; In this study,75 eligible patients will be enrolled.Each subject will~     participate in four consecutive over nights under closed-loop with MDLAP, and four additional~     over nights under regular sensor augmented pump therapy at home with a washout period of 10 ±~     3 days between arms.~   "
140611|NCT01726816|"~     This trial is randomized, placebo-controlled, double blind, double dummy, multi-centre trial.~        -  Screening period (4 week)~        -  Double blind treatment period (16 weeks)~   "
140625|NCT01726634|"~     Evaluate if the elastic tapping application on the scapular region can interferer immediately~     on the performance during the upper limb closed kinetic chain test on jiu jitsu~     practitioners.~   "
140612|NCT01726803|"~     Current practice guidelines for patients with acute low back pain (LBP) recommend a stepped~     care approach with initial treatment of education and advice to remain active. Referral to~     physical therapy is considered only when patients fail to recover after a few weeks. Recent~     research has led to the identification a subgroup of patients likely to experience rapid,~     pronounced, and sustained decreases in disability and pain with a brief manipulation and~     exercise intervention, suggesting it may be more cost-effective to manage this sub-group with~     early referral to physical therapy instead of the usual care approach. The integration of~     this evidence into routine practice has not been evaluated. We will assess the outcomes of~     integrating this evidence into the management of patients with low back pain. The study is a~     randomized trial, comparing management with early manipulation with the current care process~     model. Patients fitting the inclusion criteria will be randomized into one of two groups. One~     group will be managed with the current care process model. The other group will be managed~     consistent with the decision rule recommending early referral for a brief manipulation and~     exercise intervention during the first 4 weeks. Patients will be followed over 1 year.~     Outcomes will include measures of disability, pain, satisfaction, and direct medical costs.~     The study will examine the costs and effectiveness of integrating the alternative care model~     into practice.~   "
140613|NCT01726790|"~     To evaluate corneal endothelium cell change after intravitreal Bevacizumab injection~   "
140614|NCT01726777|"~     Type 2 diabetes (T2D) is an increasingly common and serious condition. Studies show that low~     vitamin D levels are associated with increased diabetes risk and that vitamin D may protect~     against diabetes by reducing chronic inflammation and improving insulin sensitivity and~     insulin secretion. However, no studies have been able to show that vitamin D actually reduces~     post-prandial blood glucose levels, the most clinically relevant marker of diabetes.~     Previously the investigators have shown that cheddar cheese and low-fat cheese can be~     fortified with high levels of vitamin D and that this cheese is at least as a effective as~     vitamin D supplements in raising blood vitamin D levels.~      The main purpose of this study is to see whether vitamin D enriched cheese can improve oral~     glucose tolerance (reduce blood glucose 2 hours after consuming a drink containing 75g sugar)~     in people who have low vitamin D levels and are at risk for developing T2D.~      Other aims are to determine the effect of vitamin D may on insulin sensitivity, insulin~     secretion, markers of inflammation, blood cholesterol levels, and safety markers such as~     urinary calcium excretion.~   "
140615|NCT01726764|"~     The goal of the study is to examine the difference of the pharmacokinetics of metformin with~     and without a 3 weeks pretreatment of St John's Wort. Furthermore secondary objectives~     include changes in GLP-1, C-peptide, serum-insulin and plasma-glucose during an oral glucose~     tolerance test, changes in OCT1 mRNA in plasma and changes in leptin and lipid-profile~     following this possible interaction.~   "
140616|NCT01726751|"~     To elucidate Spinal Cord Stimulation (SCS) as treatment for IBS. An SCS system with a 4-polar~     electrode at the T5-8 level is implanted. In a randomized, cross-over study design, active~     stimulation is compared to a period without stimulation, with an ensuing tailing stimulation~     period, twice as long. Patients recorded average pain level, pain attacks, number of~     diarrheas and global quality of life. At the end of the study patients can choose to retain~     their SCS stimulation system or have it removed.~      The outcome of the present trial will show whether SCS is a useful treatment of IBS. The~     long-term follow-up will show the continuous amelioration of SCS over at least six months.~   "
140617|NCT01726738|"~     This phase II study in 20 patients with BRAFV600E mutant, unresectable stage III/IV melanoma~     is designed to explore the mechanisms by which tumors acquire resistance to the combination~     of a BRAF inhibitor (dabrafenib) and MEK inhibitor (trametinib). Tissue will be collected at~     baseline and at progression.If a subject is removed from the study for one of a variety of~     reasons including, but not limited to, an inability to tolerate the combination of dabrafenib~     and trametinib, a need to receive other therapy or completion of 3-years of study treatment~     without progression, and the subject later receives, as part of his/her standard of care, the~     combination of dabrafenib and trametinib and progresses on the standard of care regimen, then~     the subject may be contacted by the treating physician to be put back on to the LCCC 1128~     protocol and have a progression biopsy at this progression time point. Markers of resistance~     will be explored by performing near kinome-wide profiling on tumor samples, and in patients~     who co-enroll in institutional protocol LCCC1108, by sequencing tumors using NextGen DNA~     sequencing technology. Overall response rate and duration to this combination will also be~     assessed.~   "
140618|NCT01726725|"~     Patients are chosen to participate in this study because they will undergo a particular type~     of brain surgery to treat their hemifacial spasm. This surgery is called microvascular~     decompression (MVD) and involves the facial nerve. The facial nerve is being compressed by~     one or more blood vessels and this contact produces the facial twitches. The investigators do~     not know why a blood vessel that touches the facial nerve produces facial twitches. The~     investigators are interested in investigating this during your surgery. A total of 25~     participants are expected to participate in this study.~   "
140619|NCT01726712|"~     The Network Supported Engagement in Care (NSEC) intervention is a brief, theory based and~     culturally sensitive intervention designed to capitalize on organic yet underutilized social~     support networks in the lives of young black men who have sex with men (YBMSM) who have been~     recently diagnosed with HIV. The intervention has been developed with input from clients and~     their support network members, case managers, social workers, HIV primary care providers and~     pastoral care at a Federally Qualified Health Center. The goal of the intervention is to~     improve retention in care for newly diagnosed YBMSM who present for their first HIV primary~     care clinic appointment.~   "
140620|NCT01726699|"~     Study the genetic traits of cancerous tissues and to help improve cancer treatment by~     developing tumor models for studying new cancer drugs.~   "
140621|NCT01726686|"~     The purpose of this study is to evaluate the effect on postoperative pain and function by~     adding intraarticular continuous infusion pump with local anesthetic after total knee~     arthroplasty where local infiltration analgesia has already been given.~   "
140622|NCT01726673|"~     The purpose of this study is to evaluate if multiple therapy sessions of Transcranial Direct~     Current Stimulation (tDCS non-invasive brain stimulation) combined with robotic arm therapy~     lead to a greater functional recovery in upper limb mobility after stroke than that provided~     by robotic arm therapy alone.~   "
140626|NCT01726621|"~     This six center international study will include two United Kingdom National Health Service~     centers, two centers in Melbourne, Australia and one center each in Denmark and Spain. The~     objective of the study is to evaluate subject acceptance of the a new insulin pump and~     transmitter together with the accompanying training materials. Descriptive data from~     participant questionnaires and device uploads will be evaluated.~      Pediatric subjects between the ages of 7 - 18 years and adults from the age of 19 years of~     age upwards, who currently use an insulin pump in the management of their type 1 or type 2~     diabetes, will be invited to participate. Each subject will be trained on the study device~     and then use it for approximately six weeks. During this time there will be three in-clinic~     visits and four follow-up phone calls, scheduled at the subjects' convenience. At the end of~     this period, they will revert back to their original insulin pump and complete a~     questionnaire on the study pump training materials, features and usability.~   "
140627|NCT01726608|"~     The purpose of the study is to investigate if a technique called Simplicity III®~     Radiofrequency Neurotomy is effective in improving the management of sacroiliac joint pain.~     Currently there are a variety of treatments for managing this pain but there is still some~     doubt as to which treatments are the most effective. Simplicity III® is one such treatment~     for sacroiliac joint pain and has been used in the NHS for many years. It uses electrical~     current to generate heat around the tip of the needle placed close to the nerves that supply~     the sacro-iliac joint. This heat ablates the specific nerves supplying the joint and improves~     pain.~      The traditional method used to treat this type of pain uses multiple injections to target the~     nerves supplying the joint. This method is however both time consuming and the results are~     variable depending upon the number of injections. Therefore a new electrode, called the~     Simplicity III®, was developed to allow the treatment to be undertaken using fewer~     injections. Although this treatment has received formal approval, undergone conformity~     assessment and is available in certain specialist NHS centres for clinical use, there is~     presently limited evidence with regards to its clinical efficacy. We wish to test the~     effectiveness of this new device in treating sacroiliac joint pain. The best way to prove the~     clinical effectiveness is to compare Simplicity III® against an identical procedure where the~     electrode is not switched on and neither the patient nor the doctor is aware whether it was~     switched on. Once pain has been assessed at 3 months, those patients not receiving active~     treatment and remaining in pain will be offered the active treatment.~   "
140628|NCT01726595|"~     The investigators hypothesize that doctors and nurses can undergo a brief period of training~     and then use ultrasound to accurately measure blood flow in a forearm artery after a brief~     period when this flow is interrupted with a blood pressure cuff, a measurement the~     investigators call reactive hyperemia. Reactive hyperemia indicates whether the small blood~     vessels in the body are healthy -- lower reactive hyperemia indicates worse small blood~     vessel function. When measured by experienced ultrasound experts, low reactive hyperemia~     strongly predicts death in critically ill patients with infection (severe sepsis).~      The investigators are conducting this study to determine if doctors and nurses, without~     specific pre-existing expertise in ultrasound, can be trained to make these measurements~     accurately. If so, the investigators will prove that these measurements can be applied~     reliably in real-world practice.~      The investigators also hypothesize that reactive hyperemia predict the outcomes of illness~     not just in patients with severe infection, but in other critically ill patients as well.~      Finally, the investigators hypothesize that reduced blood flow after blood pressure cuff~     occlusion is linked with other abnormalities of blood, previously identified in critically~     ill patients. For example, red blood cells from patients with severe sepsis have been shown~     to be stiffer than normal, so they are less able to flow along the small blood vessel~     passages of the body. Red blood cells become stiffer when there is a certain type of stress~     in the body known as oxidative stress.~      If the investigators show that low reactive hyperemia, stiff red blood cells, and oxidative~     stress are linked, the investigators hope to develop new treatments that reduce oxidative~     stress, reduce the stiffness of red blood cells, and in turn improve reactive hyperemia.~     Improvements in reactive hyperemia indicate improvements in small blood vessel function.~     Better small blood vessel function means better delivery of oxygen throughout the body. The~     investigators believe that this will improve outcomes for critically ill patients.~   "
140629|NCT01726582|"~     See treatment pathways at http://www.mcw.edu/surgery/patientinfo/Pancreatic-Cancer-Trial.htm~     :~      In this clinical trial, if the doctor knows or suspects that a growth in the pancreas is~     cancer (adenocarcinoma), then a sample of the growth is tested (the test is called molecular~     profiling). The results of the test are used by the doctor to recommend therapy (chemotherapy~     and radiation therapy) that the patient will receive before having surgery to remove the~     adenocarcinoma. When the patient goes to surgery, the adenocarcinoma that is removed is~     tested again. The results of that test are used to guide the choice of therapy after surgery.~      The chemotherapy drugs and the radiation therapy used in this clinical trial are already~     approved for treatment of pancreas cancer. This trial is intended to establish which~     treatment is best for a specific patient, based on test results from that patient's actual~     adenocarcinoma. In the past, the decision as to which treatment the patient will receive was~     not based on testing of the actual adenocarcinoma.~      Hypothesis: Resectability rate, overall survival rate and progression-free survival will be~     superior in patients with adenocarcinoma of the pancreas who receive targeted personalized~     therapy, as compared to historical data of patients who received standard therapy.~   "
140630|NCT01726569|"~     1. Investigate degree of postoperative satisfaction in county level hospital glaucoma~          patients.~        2. Investigate the effect of educational intervention affect the degree of satisfaction in~          glaucoma patients.~        3. Investigate the effect factors of postoperative satisfaction.~   "
140631|NCT01726556|"~     Rigid thoracoscopy is an established procedure for the performance of pleural biopsies for~     undiagnosed pleural effusions. The semirigid thoracoscope is a relatively new instrument~     designed for the same purpose which is claimed to be more user-friendly. The two devices have~     not been compared in a head-to-head trial in published literature. The investigators attempt~     to conduct a randomised comparative trial between the two devices.~   "
140632|NCT01726543|"~     It is a comparative study of Safety and Efficacy of Canaloplasty and Non-penetrating Deep~     Sclerectomy Combined With Phacoemulsification to Treat Glaucoma and Cataract. It is a~     Randomised, Prospective Study.~   "
140633|NCT01726530|"~     Abdominal surgery causes severe postoperative pain. Multi-modal pain therapy is usually~     applied but there is no perfect choice. It depends on physician's skill and situation. The~     best regimen is patient-controlled analgesia, but it requires an expensive equipment.~     Transdermal fentanyl patch, usually used in chronic pain relief, can steadily release~     fentanyl into blood stream for 72 hours, but it has slow onset of 12 hours.~      Hypothesis: If Transdermal fentanyl patch is applied 10-12 hours before surgery, it may~     provide good analgesia for 72 hours.~   "
140634|NCT01726517|"~     This study is to evaluate the safety, tolerability, and antiviral efficacy of~     ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV),~     administered for 8 or 12 weeks of treatment in participants with chronic genotype 1 hepatitis~     C virus (HCV) infection who are treatment-naive, and for 12 weeks in participants who had~     previously received a regimen containing a protease inhibitor for the treatment of HCV.~   "
140638|NCT01726465|"~     This is a prospective double-blind randomized phase II clinical trial, with two groups of~     intervention (one with administration of N-acetylcysteine and the other with administration~     of methylprednisolone), and one group of placebo. The purpose of this study is to investigate~     the role of N-acetylcysteine and Methylprednisolone in the modulation of warm ischemia of the~     liver during hepatic resection. In fact to avoid massive blood loss in liver surgery,~     continuous or intermittent vascular clamping of the hepatic hilum ('Pringle maneuver') is~     generally used with good results. However, as a consequence, ischemia and subsequent~     reperfusion result in complex metabolic, immunological, and microvascular changes, which~     together might contribute to hepatocellular damage and dysfunction. This phenomenon, known as~     ischemia-reperfusion (IR) injury of the liver, is a complex multi-path process leading to the~     activation of some inflammatory pathways. Any patient candidate to liver resection will be~     enrolled in the study based on the aforementioned criteria. The primary objective of the~     study is to assess the real efficacy of Methylprednisolone and N-acetylcysteine in reducing~     the secondary damage from ischemia reperfusion injury in liver resection and in reducing~     inflammatory response. Secondary objective of the study is whether the reduction of~     ischemia-reperfusion injury results in: lower incidence of postoperative liver failure,~     improvement of postoperative liver function, and reduction of blood components transfusions.~     The randomization will be done the day before the operation. The drugs will be prepared in a~     blind fashion by the hospital pharmacy. The hospital pharmacy will provide to each patient a~     drip to make bolus of about an hour before the start of the liver resection and a syringe~     pump for an infusion of approximately 6 hours. If the patient is enrolled and randomized in~     the placebo arm, he/she will receive 250 ml of glucose 5% plus the infusion of 100 ml of~     glucose 5% If the patient is randomized in the Methylprednisolone arm, he/she will receive a~     dose of 500 mg in 250 ml of glucose 5% plus 100 mg of glucose 5%. If the patient is~     randomized in the N-acetylcysteine arm, he/she will receive a dose of 150 mg/kg in 250 ml of~     glucose 5% plus N-acetylcysteine 50 mg/kg in 100 ml glucose 5%. Systematic sampling of liver~     function tests will be done the day before the operation, at the end of the operation, as~     well as in postoperative day 1, 3, 5 and 7.~   "
140639|NCT01726452|"~     Primary Objective:~      To evaluate one, two and three year survival of patients treated with resection plus~     neoadjuvant and adjuvant chemotherapy versus resection plus neoadjuvant chemo radiotherapy.~      Secondary Objective(s):~      To evaluate the effect of both neoadjuvant regimens on clinical and pathological response~     rate (in particular relief of dysphagia, improvement in health related quality of life~     (HRQL), endoscopic regression, and CT-PET evidence of tumour response), tumour regression~     grade, node-positivity, post-operative pathology, disease-free survival, time to treatment~     failure, toxicity, post-operative complications and Health Related Quality of Life (HRQL).~      Exploratory Objective(s):~      Translational Research: The collection of blood and tissue samples for storage in the bio~     bank for future research.~   "
140640|NCT01726439|"~     To compare the effectiveness, in a real world practice setting in tier 2 cities of China, of~     Entecavir (ETV) monotherapy and Lamivudine (LAM) based therapies (including LAM monotherapy,~     de novo LAM + Adefovir [ADV] combination, and early add-on of ADV) among chronic hepatitis B~     (CHB) patients who are naive to NUC at enrollment to this study~   "
140641|NCT01726426|"~     The role of anaerobic bacteria in the pathogenesis of palmer arsenical keratosis is not~     known. This can be evaluated by administering probiotics. Thirty patients from an arsenic~     affected area will be provided two probiotics capsules per day orally for 12 weeks and stool~     samples will be collected for qualitative and quantitative analysis of anaerobic bacteria.~     Similar number of arsenic exposed controls and healthy volunteers from the same area will be~     included with similar protocol for comparison. Like aerobic bacteria, anaerobic bacteria may~     be modulated by probiotics in arsenicosis patients.~   "
140642|NCT01726413|"~     Diabetic peripheral neuropathy (DPN) represents a diffuse symmetric and length-dependent~     injury to peripheral nerves that has major implications on quality of life (QOL), morbidity,~     and costs from a public health perspective. Painful diabetic neuropathy affects approximately~     16% of patients with diabetes. Pharmacological agents used in the management of painful DPN~     mainly include tricyclic antidepressants, selective serotonin and norepinephrine reuptake~     inhibitors, opioid, and anti epileptic drugs. The available treatment options do not give~     total relief, are not effective in all patients, and only about one-third of patients may~     achieve more than 50% pain relief. Hence newer therapies are required for the treatment of~     DPN. The primary outcome measures will be the change from baseline to end of treatment in the~     mean 24-hour average pain intensity.~   "
140643|NCT01726400|"~     The standard treatment of chronic hepatitis C infection is pegylated interferon alpha~     combined with ribavirin. Anaemia is a common complication occurring in up to 30% of subjects.~     Unfortunately, side effects of interferon and ribavirin therapy can require dose reductions,~     reducing the likelihood of sustained viral response. Recent data shows that interferon alpha~     may increase hepcidin (a key iron regulator) production, resulting in impaired iron~     availability for production of red blood cells. In this study, we will evaluate hepcidin~     levels in 30 patients with Hepatitis C who are treated with interferon containing regimes. If~     hepcidin plays a role in interferon-induced anaemia, cheap and readily available oral~     hepcidin inhibitors could be trialled to potentially reduce the impact of interferon alpha~     induced anaemia.~   "
140644|NCT01726387|"~     Anxiety, Depression and Somatoform disorders are highly prevalent in primary care. Very often~     these conditions remain undiscovered and/or untreated.~      In order to ease this urgent health care problem in the future, the investigators conduct a~     cluster-randomized controlled trial, implementing a tandem working cooperation between a~     nurse practitioner (Counseling Assistant - CA) and a general practitioner (GP) on-site its~     own practise.~      The CA's task is to enhance the patients abilities to engage in a better self-management of~     their psychological symptoms and complaints, to enhance self-efficacy and empower the~     patients to tackle problems of daily living.~   "
140645|NCT01726374|"~     High-risk stage 1 NSGCTTs are curable with careful surveillance followed by 3 cycles of BEP~     (bleomycin, etoposide, cisplatin with 500mg/m2 of etoposide per cycle) chemotherapy for the~     40-50% of cases experiencing recurrence. Alternatively, adjuvant chemotherapy with 2 cycles~     of BEP(at a lower dose than that used for advanced disease - etoposide 360mg/m2) for these~     patients achieves the same outcome and avoids intensive surveillance, but delivers 33% more~     chemotherapy cycles on a population basis.~      If a single cycle of BEP at the dose used in advanced disease had a similar high rate of~     relapse-free survival (cure) to that seen with two lower dose cycles, this would reduce the~     overall burden of chemotherapy and healthcare resource usage and would be likely to lead to a~     change in practice globally.~   "
140646|NCT01726361|"~     The purpose of the study is to examine the effects of Multidimensional Treatment Foster Care~     compared to treatment as usual (TAU) for adolescents in Denmark in need of out-of-home~     placement.~   "
140647|NCT01726348|"~     The purpose of this study is to assess the safety and effectiveness of darunavir for the~     treatment human immunodeficiency virus-type I (HIV-1) infection among Filipino adults.~   "
140648|NCT01726335|"~     The purpose of this study is to evaluate efficacy, safety and tolerance of long-acting~     risperidone when switching from oral antipsychotics in participants with schizophrenia~     (psychiatric disorder with symptoms of emotional instability, detachment from reality, often~     with delusions and hallucinations, and withdrawal into the self).~   "
140649|NCT01726322|"~     Primary Objective :~      To determine whether pre-treatment levels of anti-mullerian hormone predicts ovarian~     follicular reserve post adjuvant or neoadjuvant chemotherapy for breast cancer and~     chemotherapy induced amenorrhea (CIA).~      Secondary Objective~        -  To evaluate the comparative ovarian toxicity of differing neo-adjuvant/ adjuvant~          chemotherapy regimens.~        -  To assess the correlation between CIA and depletion of ovarian follicular reserve.~        -  To partly externally validate preceding studies of anti-mullerian hormone levels in~          patients receiving neo-adjuvant/ adjuvant chemotherapy for breast cancer.~        -  To determine the efficacy of GNRH agonists in preservation of ovarian follicles in~          premenopausal women treated with adjuvant or neo-adjuvant chemotherapy for breast~          cancer. Administration of GNRH agonists is dependent on the treating oncologist's~          judgment of the patient's case and practices and is not to be influenced by study~          participation.~   "
140650|NCT01726309|"~     Primary Objective:~      Correlation of the skin and/or eye toxicity grade secondary to Cetuximab or Panitumumab and~     the SNP profile of the Epidermal Growth Factor Receptor (EGFR) domain III region.~      Secondary Objectives:~      Correlation of SNP profile with indicators of tumour response parameters, such as~     radiological response, duration of response, time to progression (TTP), overall survival (OS)~     time, incidence of non-dermatological adverse events.~   "
140651|NCT01726296|"~     This clinical trial studies adherence to survivorship care guidelines in health care~     providers for non-small cell lung cancer or colorectal cancer survivor care. The completion~     of an educational intervention by health care providers may increase compliance and adherence~     to National Comprehensive Cancer Network guidelines for survivorship care.~   "
140652|NCT01726283|"~     This study is being performed to evaluate the efficacy of ultraviolet-A (UVA)-induced~     cross-linking of corneal collagen (CXL) in strengthening and optimizing the biomechanical and~     biochemical stability of the cornea in patients with fruste keratoconus (FFKC), corneas that~     are suspicious for FFKC and corneas thought to be at higher risk of developing ectasia that~     will be undergoing laser vision correction.~   "
140653|NCT01726270|"~     Multicenter trial conducted in Pharmacy retail centers~   "
140654|NCT01726257|"~     The objective of this study is to assess the safety and effectiveness of the Endologix~     Nellix® System for the endovascular repair of infrarenal abdominal aortic aneurysms (AAA).~   "
140655|NCT01726244|"~     One of the most cost effective intervention is to avoid unnecessary hospitalizations in the~     national health system. These unnecessary admissions are increasing for several years,~     reaching rates of over 30% in patients with chronic obstructive pulmonary disease (COPD) or~     heart failure at two months of hospital discharge. There is scientific evidence suggesting~     that a multidisciplinary intervention consisting in controling disease and stress associated~     with disease, and modifying eating habits could reduce the number of hospitalizations due to~     disease decompensation.~      The main objective of the study is to assess the rate of readmissions at year of~     multidisciplinary intervention in patients with COPD and / or heart failure.~      We will select 144 patients who will be randomized to two groups (control and intervention~     group) and they will be followed for 12 months through 4 visits (1 month, 3 months, 6 months~     and 12 months of hospital discharge).~      Patients assigned to the intervention group will be receive three educational sessions (one~     of them will be imparted by nursing, another by the nutritionist and the last one by the~     psychologist). In addition, patients with a BMI <20 and / or> 30 will receive a closer~     monitoring by the nutritionist).~      Patients assigned to the control group will receive usual care in clinical practice.~   "
140656|NCT01726231|"~     In laparoscopy, over %50 of the all complications occur during establishment of the~     pneumoperitoneum. Lifting of the anterior abdominal wall is aimed to increase the distance~     between the abdominal wall and the intrabdominal structures. Elevation of the anterior~     abdominal wall is recommended for the access to peritoneal cavity in literatures however the~     benefit exactly has not proved. This study aimed to determine the distance from anterior~     abdominal wall to intraperitoneal structures during lifting of the abdominal wall, to~     represent this distance -on the average- generate the safe range whether or not and compare~     with this distance and patient's age, BMI and parity.~   "
140657|NCT01726218|"~     It is well known that the motor area of one hemisphere of the brain (motor cortex) controls~     the movement of the opposite of the body. However, it is not clear whether as the movement~     becomes more complicated, the motor cortex of both hemispheres of the brain are involved.~     Currently the role of the motor cortex on the same side of the body (referred to as~     ipsilateral motor cortex) in hand performance remains controversial. The investigators~     demonstrated previously in healthy subjects that transiently lowering the activity of~     ipsilateral motor cortex improved the performance of the opposite hand. What is not know are~     the mechanisms involved in these changes of behavior. Transcranial magnetic stimulation (TMS)~     is a device that allows the non- invasive stimulation of the brain. When brain is stimulated~     repetitively at a very low rate and low intensity for about 15 minutes, the stimulated brain~     area becomes less active. This effect lasts 10 minutes and is called a transient artificial~     lesion as it mimicks the effects of transiently interfering with the function of the~     stimulated brain area. In the present study the investigators will conduct experiments using~     repetitive TMS to downregulate the activity of the motor area as in previous experiments and~     measures its effect on activity of motor cortex of both hemispheres. The investigators will~     study healthy subjects. It would be important to understand the effects in more detail for~     the design of treatment strategies in patients after stroke, which will be a topic of future~     studies.~   "
140658|NCT01726205|"~     The purpose of this study is to assess the efficacy of pregabalin or pregabalin and~     continuous wound infusion versus placebo for analgesia following thoracotomy~   "
140659|NCT01726192|"~     The purpose of this study is to assess the efficacy of the hydrolocalization technique for~     placement of femoral perineural catheters in comparison with stimulating catheters. A non~     inferiority trial.~   "
140660|NCT01726179|"~     the goal of the project is to investigate the clinical efficacy of management of early caries~     lesions by resin infiltration and to further scrutinize the patient stress experiences.~   "
141122|NCT01720121|"~     This study is randomized clinical trial to verify the effect of nursing guidelines for~     patients undergoing left cardiac catheterization on an outpatient basis. Comparing three~     approaches to direct guidelines about the procedure:~        -  printed,~        -  digital video disc (DVD)~        -  conventional guidelines provide by nursing team~   "
140661|NCT01726166|"~     Urinary tract infection (UTI) is relatively common in infants, with an occurence rate of up~     to 10%. It is more frequent in male and preterm newborn infants and can lead to significant~     problems in infants including blood infections, kidney infections, and kidney scarring which~     can affect how the kidneys work later in life.~      Analysis of collected urine for the presence of bacteria or fungus is the only way to make a~     certain UTI diagnosis. Urine culture results may take 24 to 48 hours to become available.~     Sterile collection of urine can be achieved in newborn infants by urinary catheterization~     (UC) where a catheter is passed through the urethra into the bladder, suprapubic aspiration~     (SPA) where a needle is inserted into the bladder through the abdominal wall, or 'clean~     catch' where urine is collected into a sterile bottle as the baby urinates during preparation~     for UC. The main advantage of SPA is that it bypasses the bacteria that normally resides in~     the urethral opening, thus minimizing the risk of contamination. Some studies have suggested~     that SPA is better than UC for collecting urine in a sterile fashion in the neonate due to~     the difficulty of doing sterile UC in small infants resulting in more contaminated samples~     (also called a false-positive urine culture); there are some problems with the way these~     studies were done so there is still no clear best choice. UC is commonly used in many~     Neonatal Intensive Care Units (NICU) as it is considered less invasive, can be done by the~     nursing staff, and generally has a higher chance of obtaining urine. SPA is a simple and safe~     alternative and, although some studies suggest that it is more painful than UC, it it~     performed more quickly. The reported success rate for SPA is variable, but is greatly~     increased when an ultrasound confirms urine in the bladder before doing the SPA. The question~     remains: what is the best method for sterile collection of urine in newborns and young~     infants? In this study, the investigators will try to answer this question by collecting~     urine from infants admitted to our NICU using either ultrasound guided SPA or UC and then~     comparing the contamination rates between these two methods.~      The investigators hypothesize that SPA will result in less contamination of urine samples.~      The investigators also hypothesize that there will be more success in obtaining an adequate~     urine sample (0.5 ml) by SPA, SPA will be quicker to perform, and that there will be no~     difference in associated complication rates between SPA and UC.~   "
140662|NCT01726153|"~     The purpose of this study is to evaluate the efficacy of an online intervention in increasing~     condom use among HIV+ gay males.~   "
140663|NCT01726140|"~     The aim of study is to evaluate whether the application of a continuous positive airway~     pressure (CPAP) after extubation in patients undergoing cardiac surgery can reduce hypoxemia~     and re-intubation rate.~   "
140664|NCT01726127|"~     The 2010 Dietary Guidelines for Americans recommend that individuals consume 4.5 to 5 cups~     fruits and vegetables daily. However, at current intake levels, fruit consumption will have~     to improve by more than 100% and vegetable intake by 50% to meet this recommendation.~     Importantly, intake of brightly colored fruits and vegetables is even lower when potatoes are~     not considered. It is possible that improved fruit and vegetable intake will have beneficial~     health effects. For example, higher intakes of fruits and vegetables, and particularly~     cruciferous vegetables (e.g., broccoli, Brussels sprouts, cauliflower, etc.), are associated~     with lower rates of many degenerative diseases, including some cancers, yet this group of~     vegetables may continue to be under-consumed due to their strong flavors. A supplement made~     from these vegetables (Cruciferous CompleteTM made by Standard Process Inc. Palmyra, WI)~     contains a group of phytochemicals called glucosinolates that can shift estrogen metabolism~     in a favorable way. One proposed biomarker of chemoprotection from breast cancer is the~     urinary estrogen metabolite ratio of 2- to 16α-hydroxyestrogens (2:16). In the main study,~     the effects of cruciferous vegetables (broccoli or Brussels sprouts), Cruciferous CompleteTM~     whole food supplements, or placebos on this ratio of urinary estrogen metabolites in healthy~     premenopausal women will be compared over an eight-week period. The investigators hypothesize~     that treatment with daily supplements will increase the 2:16 ratio as compared to daily~     consumption of a combination of Brussels sprouts and broccoli or a placebo, suggesting~     reduced breast cancer risk.~      In a sub-study, the relationships between serum α-carotene, β-carotene, β-cryptoxanthin,~     lutein and lycopene with dietary carotenoid intake as measured by a food frequency~     questionnaire and body composition will be evaluated in healthy premenopausal women.~     Carotenoids are a family of lipophilic compounds found primarily in colorful plant tissues~     and their concentration in human blood reflects dietary intake of carotenoid-rich foods.~     Carotenoid levels in the blood of healthy women do not appear to be influenced by menstrual~     status, but are inversely associated with body fatness. Thus, serum carotenoid concentrations~     may serve as a functional marker for chronic disease risk associated with excess body fat.~   "
140665|NCT01726114|"~     The purpose of this study is to compare glucose measurements from the C8 MediSensors~     non-invasive Optical Glucose Monitor™ System to blood glucose measurements from the Yellow~     Springs Instrument(YSI) blood glucose analyzer.~   "
140666|NCT01726088|"~     The purpose of this study is to determine if modafinil is more effective than placebo in the~     treatment of posttraumatic stress disorder (PTSD) in male combat veterans who have been~     deployed to Iraq or Afghanistan.~   "
140667|NCT01726075|"~     To assess whether neuroprotective drugs administered topically (somatostatin and brimonidine)~     are able to prevent or arrest the development and progression of neurodegenerative changes~   "
140668|NCT01726062|"~     A randomized, controlled, parallel group design will be used to test whether a Secondhand~     Smoke Exposure program initiated in the hospital and completed in the home using motivational~     interviewing plus motivational incentives (MI+) is more effective than Conventional Care (CC)~     with Neonatal Incentives Care Unit Infants' parents.~   "
140669|NCT01726049|"~     Aim of the study is to investigate whether Sildenafil treatment results in a reduction of~     pulmonary artery pressure without decrease of cardiac output (CO) and in improvement of~     exercise capacity in patients with heart failure with preserved ejection fraction (HFpEF)~     with pulmonary hypertension ( PH).~   "
140670|NCT01726036|"~     The purpose of this study is to compare two commonly used circumcision clamps (Gomco and~     Mogen) to see which results in less neonatal pain.~   "
140671|NCT01726023|"~     The purpose of this study is to evaluate the effects of Ceftazidime Avibactam plus~     Metronidazole compared to Meropenem for treating hospitalized patients with complicated~     intra-abdominal infections.~   "
140672|NCT01726010|"~     The goal of this prospective study is to evaluate the feasibility of the 22-G Core Biopsy~     Needle with reverse bevel (Procore TM) in biopsy sampling of subepithelial tumors of the~     upper gastrointestinal tract.~   "
140673|NCT01725997|"~     The study aims to answer if surgery with hook plate for acute dislocation of the~     acromioclavicular joint (AC joint) grade III and V according to Rockwood is superior to~     conservative treatment.~   "
140674|NCT01725984|"~     A single-center retrospective chart review of AdVance and AdVance XP subject data, combined~     with prospective follow-up of the same subjects to confirm continence, adverse event, and~     quality of life status. This study includes patients previously implanted with an AdVance or~     AdVance XP male sling.~   "
140708|NCT01725542|"~     Evaluation of efficacy and tolerance to a QUadruple therapy with Asunaprevir , Daclatasvir,~     Ribavirin and pegylated Interferon alpha-2a, in HIV-HCV genotype 1 or 4 coinfected patients~     previously null responders to a standard Pegylated Interferon -Ribavirin regimen.~      The proportion of patients presenting cirrhosis (defined by a METAVIR F4 score on liver~     biopsy and/or with hepatic impulse elastometry ≥ 15 kPa) will be limited to 50% of all of the~     patients included~   "
140709|NCT01725529|"~     The purpose of this study is to provide confirmatory efficacy and safety data of TMC435 as~     part of a treatment regimen including peginterferon-alpha (PegIFNα-2a) and ribavirin (RBV) in~     patients with genotype 1 Hepatitis C virus (HCV) infection.~   "
140710|NCT01725516|"~     The purpose of this study is to determine whether myofascial release technique are effective~     in the treatment of low back pain due to lumbar disc herniation.~   "
140675|NCT01725971|"~     Silicosis is a chronic and incurable occupational disease that can progress independent of~     the end of exposure. Recent works suggest that the Forced Oscillation Technique (FOT) may~     help to improve our understanding of the changes in lung mechanics, as well as in the~     detection of these changes.~      Objectives: Analyze the effects of airway obstruction in silicosis on the respiratory~     impedance and evaluated the diagnostic use of the FOT in these patients. For this, the~     investigators used spirometry to classify airway obstruction, which resulted in four~     categories: control, patients with normal exam, mild obstruction, and moderate-to-severe~     obstruction. Resistive data were interpreted using the zero-intercept resistance (R0), the~     resistance at 4 Hz (Rrs4) and the mean resistance (Rm). The investigators also analyzed the~     mean reactance (Xm) and the dynamic compliance (Crs,dyn). The total mechanical load was~     evaluated using the absolute value of the respiratory impedance (Z4Hz). The diagnostic~     potential was evaluated by investigating the area under the receiver operating characteristic~     curve (AUC).~   "
140676|NCT01725958|"~     Title: A Phase IV, Open-label, Single-Center Study on the Effects of a Nutritional Supplement~     Combination on Body Weight Management over a 90-day period~   "
140677|NCT01725945|"~     Dietary intervention efficacy trials are distinctly lacking in asthma research. This pilot~     study aims to provide effect size estimates and justification, clinical trial and~     intervention feasibility data, and procedural materials for a full-scale randomized~     controlled trial that will determine the efficacy and mechanisms of action of the Dietary~     Approaches to Stop Hypertension (DASH)—a recommended dietary pattern based on proven~     cardiovascular benefits—as adjunct therapy to standard care for adults with uncontrolled~     asthma.~   "
140678|NCT01725932|"~     While CBT (Cognitive Behaviour Therapy)has been found to be effective in treating depression~     in West, only limited amount of research has been conducted to find assess its effectiveness~     in low and middle income countries. We have developed culturally sensitive CBT during the~     last few years in Pakistan. Pakistan has high rates of depression. And there is currently a~     need to develop and test evidence based treatments which are culturally sensitive and cost~     effective. IN this project we will be assessing the effectiveness of a culturally sensitive~     CBT based self help intervention for depression in Pakistan against care as usual, using a~     randomized controlled design.~   "
140679|NCT01725919|"~     Constraint-induced movement therapy (CI therapy) is a highly efficacious treatment for~     residual motor disability in chronic stroke. Its effectiveness is believed to be due, at~     least in part, to the therapy's ability to aid the brain in rewiring itself. For example,~     CI therapy produces increases in the amount of grey matter (the parts of the brain where~     neuron cell bodies are most closely clustered) in certain areas of the human brain (Gauthier~     et al., 2008). The cellular and molecular mechanisms that are responsible for this increase~     in grey matter volume are not known, however. Thus, it is unclear how the therapy helps~     brains rewire themselves. This study aims to better understand the timecourse and~     cellular/molecular nature of brain changes during CI therapy. Because there is currently no~     way to directly measure cellular/molecular changes in the brain noninvasively, this study~     will infer what is happening on a microstructural level using new MRI techniques (three~     dimensional pictures of the brain). For example, by charting the timecourse of grey matter~     changes during CI therapy, and cross-comparing this to what is known about the timecourses of~     different cellular/molecular processes, the investigators can gain a greater understanding of~     what cellular processes may be responsible for increases in grey matter. The investigators~     will gain additional information about which cellular processes are important for~     rehabilitation-induced improvement by measuring larger-scale changes (e.g., amount of blood~     flow through different brain areas) that accompany cellular changes. The investigators are~     hopeful that by better understanding how CI therapy can change the brain, the effectiveness~     of rehabilitation can be improved upon. For example, insight into the mechanisms of~     rehabilitation-induced brain change may suggest particular drug targets to increase brain~     plasticity. This study will help us better understand how the brain repairs itself after~     injury.~   "
140680|NCT01725906|"~     We aimed to compare the efficacy of genotypic resistance guided sequential therapy vs.~     empiric therapy in the third line therapy. Factors affecting the eradication rates, including~     the antibiotic resistance, CYP2C19 polymorphism, CagA and VacA status will also be assessed.~   "
140681|NCT01725893|"~     Checkrein deformity represents a dynamic claw toe deformity. Surgical intervention is the~     treatment of choice and many methods have been proposed. The purpose of this study is to~     evaluate the outcomes and complications of percutaneous segmental tenotomy of the toe flexor~     tendons.~   "
140682|NCT01725880|"~     The purpose of this study is to determine the long term safety and preliminary efficacy of~     intramedullary transplantation of HuCNS-SC cells in subjects with thoracic spinal cord~     trauma.~   "
140683|NCT01725867|"~     the purpose of this study is to compare the effect of physical therapy (PT) program and oral~     appliance on patients with temporomandibular disorder (TMD)-related myofascial pain (MFP).~   "
140684|NCT01725854|"~     The purposes of this study are to evaluate the acceptability and utility of a mind-body~     intervention on a convenience sample of Soldiers (n=120) who have screened positive through~     RESPECT-MIL for symptoms that may lead to post-traumatic stress and to test the effectiveness~     of this Relaxation Response (RR) intervention designed to decrease the physiological and~     psychosocial effects of stress and trauma. The study aims to enhance the psychological health~     of Soldiers with a RR intervention designed to promote self-awareness of physiological~     responses to stress and the ability to increase relaxation responses.~   "
140685|NCT01725841|"~     Resistance to broad-spectrum cephalosporins through the acquisition and expression of~     Extended-Spectrum β-lactamase (ESBL) among Enterobacteriacea is increasing. The clinical~     implications of ESBLs are extremely serious and sensitive diagnostic methods are urgently~     needed to guide therapy, monitor resistance development and implement intervention~     strategies. Conventionally, detection of expression of ESBLs was based on reduction of~     ceftazidime of cefotaxime MICs by ≥ 3 two fold dilutions in the presence of clavulanic acid.~     However, the use of the above method was limited to cover only some of the bacterial species,~     including predominantly E. coli and Klebsiella spp., or tested strains which were all~     transconjugants generated in vitro. ESBLs are now reported in a growing number of genera~     other than E. coli or Klebsiella spp., and Serratia marcescens.~      Carbapenems, including ertapenem, imipenem and meropenem, are the drugs of choice used for~     severe ESBL-producing bacterial infections. Failure to detect ESBL at the presence of AmpC~     β-lactamase might result in an important clinical concern because 4th generation~     cephalosporins, which are stable to AmpC β-lactamase, is not a drug of choice for severe~     infections caused by ESBLs-producing isolates. Fluoroquinolone-resistance in ESBL-producing~     Enterobacteriacea is common. In this study, the investigators will use isolates of~     Enterobacteriacea collected from different hospitals (isolates offered by the Taiwan~     Surveillance of Antimicrobial Resistance [TSAR] program) to investigate the susceptibility of~     ertapenem and five other antimicrobial agents against ESBLs-producing Enterobacteriacea.~   "
140686|NCT01725828|"~     Routine surgery requires artificial breathing through the placement of a plastic tube into~     the patient's windpipe via mouth or nose. This tube serves as the source of providing oxygen~     to the patients during surgery. Difficulties during insertion of this tube may lead to~     serious complications and during this life-threatening crisis the only way to provide oxygen~     to the patient is by the help of a procedure called cricothyrotomy (CTY).~      CTY is a life saving procedure that involves an incision on the patient neck at a very~     precise location called Cricothyroid Membrane (CTM). The current method of identifying this~     location is by palpation of neck cartilages by the operator. The incorrect identification of~     the CTM could lead to many complications. In certain patients such as obese or distorted neck~     features the identification of CTM would be difficult. Ultrasound (US) has improved the~     success rate of many anesthesia procedures .Its use has been described for identification of~     neck structures; however, this technique of localization has not been validated against the~     gold standard which is the use of CT scan. The purpose of our study is to determine the~     precision of identifying the CTM using the US versus the conventional finger palpation when~     compared to the gold standard.~   "
140687|NCT01725815|"~     Persons with serious mental illnesses (SMI) face elevated rates of medical comorbidity, and~     also challenges in effectively managing these health problems. There is an urgent need to~     develop self-management strategies that allow persons with SMI to more effectively manage~     their chronic medical illnesses.~      In general populations, peer-led disease self-management interventions have been demonstrated~     to be feasible, effective, scalable, and to lead to sustainable improvements in~     self-management and health outcomes. With funding from an R34 intervention development grant~     from NIMH, the study team has developed and piloted a modified version of the most widely~     tested and used peer-led self management program, the Chronic Disease Self-Management Program~     (CDSMP), for persons with serious mental illness. Two pilot tests of this intervention, the~     Health and Recovery Peer (HARP) program, demonstrated that the program can be implemented~     with high engagement, retention, and program fidelity, and can result in effect sizes across~     a range of outcomes comparable to or greater than those seen in general medical populations.~      This application proposes to conduct a fully-powered, multisite trial of the HARP program. A~     total of 400 individuals with serious mental illnesses and one or more chronic medical~     condition will be recruited from three diverse community mental health clinics in the Atlanta~     metro region and randomized to the HARP program or usual care. For individuals in the HARP~     program, two peer educators with SMI and one or more chronic medical condition will lead a~     six-session, six-week manualized intervention, which helps participants become more effective~     managers of their chronic illnesses. Follow-up interviews and chart reviews at 3 months, 6~     months and one year will assess changes in clinical outcomes, improvement in generic and~     disease-specific measures of illness self-management, and quality of care. During the final~     phase of the study, a dissemination strategy building on the CDSMP training infrastructure~     will allow program participants to lead HARP groups.~      If successful, this study will establish the first fully peer-led, evidence-based~     intervention for improving physical self-management in this vulnerable population.~   "
140688|NCT01725802|"~     In this Phase I/IIa study, the effect of continuous subcutaneous administration of LD/CD~     solution (ND0612) on the safety and PK profile of LD will be examined.~   "
140689|NCT01725789|"~     This study is designed to evaluate the efficacy of Ferinject® in improving acute isovolemic~     anemia after gastrectomy for gastric cancer in terms of Quality of life(QOL )and objective~     measures (Hb and iron parameters).~      Furthermore, the tolerability and safety of Ferinject® treatment will be evaluated.~   "
140690|NCT01725776|"~     The purpose of this study is to investigate the concentration-effect relationship of inhaled~     milrinone after prophylactic administration in cardiac surgical patients with preoperative~     pulmonary hypertension undergoing cardiopulmonary bypass.~   "
140691|NCT01725763|"~     Pulmonary hypertension (PH) is a life-threatening cardiovascular disease characterized by~     pathological elevation of mean pulmonary arterial pressure (mPAP) >/= 25 mmHg at rest. mPAP <~     20 mmHg is defined as normal, values in the range between 21-24 mmHg are described as~     borderline PH diagnosed by right heart catheterization. Based on the etiology, PH is~     assigned to 5 groups (WHO, Data Point, 2008), whereas classification of disease is an~     important prognostic and therapy-deciding criterion.~      Cardiac magnetic resonance tomography (CMR) provides a reliable technique to estimate~     elevated mean pulmonary arterial pressure from period of existence of a vortical motion of~     blood flow in the main pulmonary artery. Vortex can be visualized in 3-dimensional vector~     field, particle trace and streamline representations and can be analysed with respect to~     vortex related measures (geometry of center, vortex formation, vorticity, propagation~     dynamics …). Furthermore T1-mapping and non-contrast enhanced lung perfusion/ventilation~     scans represent promising techniques for PH characterization.~      Aim of this explorative study is to 1. analyse PH-associated blood flow characteristics in~     the heart and the surrounding great vessels with respect to the 5 groups of PH, and 2.~     investigate the hemodynamic state of borderline PH compared to normal mPAP and manifest PH~     by non-contrast CMR.~   "
140692|NCT01725750|"~     This study aims to evaluate the efficacy of 4 weeks of daily light exposure in reducing~     Post-Traumatic Brain Injury (TBI) Fatigue immediately post-treatment and at a one-month~     follow up. The investigators hypothesize that individuals receiving 4 weeks of bright white~     light treatment will report significant reductions in fatigue compared to individuals~     receiving dim red light treatment for the same duration of time, and that these treatment~     effects will be maintained one month after treatment completion.~   "
140693|NCT01725737|"~     Although psychostimulant is the first line of drug to treat Attention Deficit Hyperactivity~     Disorder, (ADHD), actually there are 10-20% ADHD patient do not response well to current~     medication. Most of parents of children with ADHD in Taiwan dislike to use psychostimulant.~     We expect that GlyTI-M will have better efficacy than placebo to reduce ADHD symptoms. This~     study will also help us to understand the mechanism of ADHD and give a way to develop new~     drug and also a more possible way to treat ADHD children under 6 years old.~   "
140694|NCT01725724|"~     The purpose of this study is to compare the infection rate in patients receiving/not~     receiving their own blood, collected during surgery, during and after orthopedic surgery.~      The hypothesis is that transfusion of autologous salvaged blood may reduce postoperative~     infection.~   "
140695|NCT01725711|"~     Patients with transfemoral amputations (TFA) frequently experience problems related to the~     use of socket-suspended prostheses 1-3. These problems increase with short or deformed stumps~     4. The potential for improvement is substantial. Based on the very good long-term results~     with osseointegrated titanium implants for edentulous patients 5, osseointegrated hearing~     aids 6, cranio-facial prostheses 7 and prostheses for thumb-amputated patients 8, the~     clinical development of osseointegrated prostheses for TFA started in 1990, in Gothenburg,~     Sweden. The concept has gradually been modified and improved. In 1999, a prospective clinical~     trial began.~      The hypothesis is that the treatment will improve quality of life.~   "
140696|NCT01725698|"~     This research is aimed to evaluate the combination of mesenchymal stem cell, HA-CaSO4, BMP-2,~     and implant in treating critical-sized bone defect.~      In the presence of critical-sized bone defect whose defect size is more than 2.5 cm, bone~     will suffer a healing disturbance. In treating these conditions, the conventional method were~     vascularised bone grafting and bone transport. But the existing methods of treatment have~     many weaknesses Vascularized bone graft is a procedure with a high level of difficulty. Hence~     not every orthopaedic surgeon were able to perform it. It also takes more operating time and~     its failure rate is also quite high.~      Meanwhile, external fixation which is applied with bone transport, was being often complained~     by the patient in terms of cosmetic and psychologically.~      According to diamond concept of bone healing, there are four main factors that influence the~     bone healing. These factors are osteogenic factor (mesenchymal stem cell), osteconductive~     factor (HA-CaSO4), osteoinductive factor (bone morphogenetic protein-2) and mechanical~     component (implant). The potency of each component in fracture healing with/out bone defect~     has been proved in many studies. The combined effect of these components is often studied as~     well, but not in critical-sized bone defect.~   "
140697|NCT01725685|"~     This will be a randomized, double-blind, single-dose, three-period balanced crossover study~     in adult healthy subjects. Each of the 18 subjects will be randomized to receive a treatment~     sequence consisting of each of the three treatments (FF 400 microgram (mcg), UMEC 500 mcg and~     FF 400 mcg/UMEC 500 mcg), in three consecutive periods, with a wash-out period of 7 to 10~     days between the periods.~      The study will include a Screening period (28 days prior to first dose), Treatment period (3~     single dose periods separated by two 7 to 10 days washout periods) and Follow-up period (7 to~     14 days post last dose).~      The pharmacokinetic (PK) and safety assessments will be performed during the study at fixed~     timepoints.~   "
140698|NCT01725672|"~     This is a an open-label, randomized, single dose, four-way crossover, multi-stage study~     enrolling 20 healthy adult male and female subjects per part. This study consists of two~     separate parts (Part A and B) with each part comprising four treatment periods. Each subject~     will participate in all four treatment periods per part; Subjects may not enrol in both Parts~     A and B.~      This study is being conducted to compare the pharmacokinetics (PK) of two extended release~     fixed dose combinations (FDC) oral formulations of metformin and glimepiride at two doses,~     500mg/1mg and 1000mg/2mg, with each FDC formulation to be administered orally as a single~     dose and compared with the commercially available formulations of metformin extended release~     (XR) (GLUCOPHAGE ™ Sustained Release [SR]) and glimepiride immediate release (IR) (AMARYL ™).~      Part A of study will evaluate the bioavailability of a formulation comprising a film coated~     tablet containing release controlling polymers; and Part B will evaluate the bioavailability~     of a formulation comprising a tablet coated with release controlling polymers.~      In each part there will be 4 treatment periods. During each period, subjects will be~     randomized sequentially to receive a single dose of a reference treatment of 500 mg metformin~     XR / 1 mg glimepiride IR; and a reference treatment of 1000 mg metformin XR / 2 mg~     glimepiride IR; and an FDC tablet containing 500 mg metformin XR and 1 mg glimepiride XR; and~     an FDC tablet containing 1000 mg metformin XR and 2 mg glimepiride XR.Serial PK sampling for~     up to 36 hours and safety assessments will be performed. Each period will be separated by a~     washout period of at least 5 days and a follow-up visit will occur 14 days after the last~     dose of study drug.~   "
140699|NCT01725659|"~     PURPOSE. After stroke many patients are unable to engage in normal upper limb functional~     activities, which may restrict them from participation in meaningful life roles. For many,~     conventional rehabilitation does not restore upper limb function to a useful level. The~     purpose of this research is to investigate the benefits of three promising motor learning~     interventions: focused intensive, motor learning (FIML); 2) robotics and motor learning~     (ROB-ML); and 3) functional neuromuscular stimulation and motor learning (FNS-ML).~   "
140700|NCT01725646|"~     1. Evaluation of the efficacy of Omacor® in Taiwanese hypertriglyceridemia patients~        2. Evaluation of the safety of Omacor® in Taiwanese hypertriglyceridemia patients~   "
140701|NCT01725633|"~     This study is being done to examine the safety and feasibility of a supervised progressive~     exercise program in women diagnosed with metastatic breast cancer. Previous research among~     women with metastatic breast cancer has shown that some of the treatments commonly used in~     this population may have an adverse impact on physical fitness levels leading to feelings of~     fatigue and poor quality of life. Supervised exercise training has been shown to reduce some~     of these side-effects in women with early-stage breast cancer receiving common cancer~     treatments. However, it is not known if supervised exercise training is a safe and feasible~     intervention in women with metastatic breast cancer. This study is designed to find out if~     supervised exercise training is safe as the patients undergo treatments for metastatic breast~     cancer.~   "
140702|NCT01725620|"~     To compare the pharmacokinetic characteristic of LBEC0101 25mg with active comparator,~     Enbrel® 25mg.~   "
140703|NCT01725607|"~     We designed a study to determine whether a single dose of dexmedetomidine or thoracic~     epidural anesthesia combined with general anesthesia would provide hemodynamic stability,~     reduce stress hormone responses, inhibit inflammatory cytokine secretion, and improve sleep~     quality in patients after thoracic surgery.~   "
140704|NCT01725594|"~     This is a two-part Phase 1 placebo-controlled, double-blind, randomized single and multiple~     ascending dose study. In Part A, CAT-2003 is administered as a single dose; at two doses~     (1000 and 2000 mg), subjects will return for a second dose of CAT-2003 or placebo after a~     high fat meal. In Part B, CAT-2003 is administered for 14 consecutive days.~   "
140705|NCT01725581|"~     The purpose of this study is to show that a new assessment tool for pelvic examination is~     valid and reliable.~   "
140706|NCT01725568|"~     The BioMonitor is an implantable cardiac monitor used to automatically detect and record~     episodes of arrhythmia in patients with bradycardia, tachycardia, asystole and atrial~     fibrillation. The study will be conducted to support regulatory approvals outside of Europe.~     This BioMonitor Master study is designed to investigate the clinical efficacy and safety of~     the BioMonitor.~   "
140707|NCT01725555|"~     This is a prospective, randomized, open-label, Phase I, crossover study to assess the effect~     of food on the bioavailability of AXL1717 including patients with advanced malignant tumors~   "
140711|NCT01725503|"~     The goal of the present study is to quantify the rate of synthesis of creatine in healthy~     controls and endurance trained subjects. In addition, the effect of oral creatine supplement~     for seven days on creatine kinetics will be examined.~      Ten healthy controls (age 20-35 years) and ten endurance trained subjects will be recruited~     by advertisement. Endurance trained subjects will be recruited from health clubs. They will~     be screened for absence of any chronic disease (history, physical examination, CBC, metabolic~     and liver panel, urinalysis). A DEXA measurement will be done to quantify whole body skeletal~     muscle mass.~      For five (5) days prior to the study, they will be placed on a creatine-free (essentially~     meat-free) diet. Dietary compliance will be ensured by repeated communication with the~     subject, by nurse coordinator and the CRU Nutritionist. Subject will maintain daily record of~     the food intake for validation. On the last day, i.e. 24 hours prior to the tracer study,~     subject will collect the 24 hours urine sample and bring it to the CRU on the day of the~     study.~   "
140712|NCT01725490|"~     Familial adenomatous polyposis (FAP) leads to adenomas and eventual adenocarcinomas in colon~     and less frequently, duodenum. Chemopreventive strategies have been studied in FAP patients~     to delay the development of adenomas and cancers. The non-steroidal anti-inflammatory drugs~     (NSAIDs) and selective cyclooxygenase-2 inhibitor have shown the regression of colorectal and~     duodenal adenomas in FAP patients. However, these drugs showed gastrointestinal damage and~     cardiovascular risks, and new preventive strategies are needed. Metformin, a biguanide, which~     is widely used for treating diabetes mellitus, has recently been suggested to have a~     suppressive effect on tumorigenesis via mTOR-inhibiting pathway, and have no significant~     safety issues in long term use. The investigators devised a double-blind randomized~     controlled trial to evaluate the effect of metformin on polyps of colorectum and duodenum in~     non-diabetic FAP patients.~   "
140713|NCT01725477|"~     1. Methylene blue in laparoscopy use for tubal patency assessment~        2. Methylene blue could have negative effect on sperm motility, oocyte granulosa cell and~          fertility.~        3. tubal washing after Methylene blue administration could be effective in pregnancy rate~          after operation.~   "
140714|NCT01725464|"~     During early postoperative after lung resection surgery, patients without oxygen~     supplementation may experience hypoxemia. Oxygen supplementation can be given via oxygen mask~     or cannular. In this study the investigators want to the sudy the effect of oxygen~     supplementation via oxygen cannular during the first 120 minutes after surgery~   "
140715|NCT01725451|"~     This study will evaluate the effect of deodorant and antiperspirant use and the presence of~     underarm hair on the absorption of testosterone. Each participant in this study will receive~     6 single doses of 30 milligrams (mg) testosterone applied as a solution to each underarm.~     There is a minimum one day washout period between each dose. This study will last~     approximately 24 days not including screening. Screening is required within 30 days prior to~     the start of the study.~   "
140716|NCT01725438|"~     The objective of this project is to develop a non-invasive prenatal diagnostic test for~     trisomy 21 which is reliable, sensitive and cost-effective, and thus, offers an alternative~     to the currently employed invasive diagnostic tests amniocentesis and chorionic villus~     sampling.~      Current prenatal screening methods (blood markers and ultrasound) for trisomy 21 (Down~     syndrome) detect about 90 % of cases and have a false positive rate of > 90 %. The results of~     these tests are expressed in risks for trisomy 21, the threshold being in France at 1/250.~     Women exhibiting a higher risk are offered to undergo invasive diagnostic testing, either by~     amniocentesis or chorionic villus sampling. However, these invasive diagnostic methods are~     associated with a considerable risk of miscarriage (1-3 %), and thus underline the importance~     to develop a safe and non-invasive prenatal diagnostic test for trisomy 21. The investigators~     have planned to assess the clinical impact of a non-invasive prenatal method to detect~     Trisomy 21 through genetic analysis of circulating trophoblastic cells.~   "
140717|NCT01725425|"~     The purpose of this study is to investigate whether different portion sizes will effect~     overall mood.~   "
140718|NCT01725412|"~     Thiamine is a key component in the creation of physiologic anti-inflammatory mediators. Serum~     thiamine stores have been found to be deficient in diabetic patients. Thiamine deficiency may~     be a key pathological mechanism of inflammation that results in diabetic kidney and retinal~     injury. The investigators hypothesize that the repletion of a patient's thiamine by oral~     supplementation may result in reduced inflammation, and therefore reduced kidney injury.~   "
140719|NCT01725399|"~     Second only to pain, nausea and vomiting are the most uncomfortable complications of surgery~     and anesthesia. Unfortunately, our best defense against post-operative nausea and vomiting, a~     medicine called ondansetron (Zofran), is in dire national shortage. Consequently,~     non-pharmacological methods of prevention and treatment for post-operative nausea and~     vomiting have increased import. Following emergence from general anesthesia, children often~     request food and drink. There have been no studies to date that definitively determine the~     optimal first food or drink choice for these children. This study proposes to randomize~     children to either water or juice first intake following surgery. The investigators expect to~     find that children who consume glucose are less likely to vomit than those who first receive~     water.~   "
140720|NCT01725386|"~     This observational study will evaluate the routine clinical use and the safety and efficacy~     of capecitabine (Xeloda®) in participants with metastatic or advanced breast cancer. Eligible~     participants will be followed for up to 24 months.~   "
140721|NCT01725373|"~     In patients with unprotected left main disease (ULMD), angioplasty is emerging as an~     alternative technique. The investigators aimed to determine the rate of major cardiovascular~     events in patients treated by angioplasty for ULMD in a real world registry.~   "
140722|NCT01725360|"~     Control of airway inflammation is the cornerstone of asthma management. The aim of the~     present pilot study was to assess whether, and in which magnitude, a leukotriene receptor~     antagonist (LTRA) added to a basic treatment of inhaled corticosteroids (ICS) + long-acting~     betamimetics (LABA) might improve airway hyperresponsiveness and inflammation in~     well-controlled patients with asthma.~   "
141123|NCT01720108|"~     In this study the investigators want to look at whether using aspirin instead of rivaroxaban~     (after initial treatment with rivaroxaban) works as well at preventing blood clots while also~     reducing risk of bleeding and is more cost effective in patients who have either a total hip~     replacement or total knee replacement.~   "
140723|NCT01725347|"~     The Validation of a Digital Diet Method project is very innovative because it links three~     methods to address the gap in measuring food intake of HS preschool children. Data collection~     is based on EMA theory; participant burden is low, and the Food Image App decreases~     participant and staff burden even further. Data management and analysis are semi-automated~     and relies on advanced computer algorithms. A strength of this approach is its~     semi-automation, which allows us to leverage the strengths of human operators and computer~     automation.~   "
140724|NCT01725334|"~     Schizophrenia is a complex, challenging, and heterogeneous psychiatric condition, affecting~     up to 0.5% of the population and responsible for nearly 2% of all Canadian health-care~     expenditure. Much of the morbidity of the illness is related to its negative symptoms,~     including amotivation, asociality, anhedonia and flattened emotional affect, which lead to~     functional impairment and withdrawal from social and occupational domains. In contrast to~     positive symptoms, such as hallucinations and delusions, there are currently no effective~     treatments for negative symptoms, which experts recognize are largely responsible for the~     long-term disability of a majority of patients with schizophrenia. Advances in neuroscience~     have allowed a greater understanding of negative symptoms and have identified key structures~     and circuits believed to generate and maintain them. Here, we propose the application of a~     targeted therapy, deep brain stimulation, to alter the circuits driving negative symptoms.~   "
140725|NCT01725321|"~     Although colonoscopy is considered the gold standard for diagnosis of colonic polyps, the~     missed rate for colonic adenoma ranged from 15-32%. In particular, missed colonic polyps in~     the right side colon have been suggested to be the cause for interval cancer that developed~     after a prior negative colonoscopy.~      Different endoscopic image enhanced modules like the narrow band imaging (NBI) have been~     developed to improve colonic polyp detection. However, it remains controversial whether the~     previous version of NBI helps to improve colonic polyp detection. The new generation~     colonoscope is equipped with high definition and improved narrow band imaging (NBI) which~     gives at least twice the viewable distance and contrast. The images obtained are far brighter~     with better resolution than the previous version. It however remains to be determined whether~     this enhanced imaging technique could help to improve colonic polyps detection.~      Hypothesis:~      The new generation NBI increases the detection rate of proximal serrated polyps and reduces~     the missed rate of all colorectal polyps.~      Aims:~        -  To determine whether the new generation NBI improve the detection rate of proximal~          serrated polyps.~        -  To determine whether the new generation NBI improve the detection rate of all colorectal~          adenoma and polyps.~        -  To determine whether the new generation NBI reduce the miss rate of colorectal adenoma~          and polyps.~   "
140726|NCT01725308|"~     In period I, the treatment effect of FK949E was compared with that of placebo in a blind~     manner in bipolar disorder patients with major depressive episodes. In period II, the~     long-term safety and efficacy of FK949E was evaluated.~   "
140727|NCT01725295|"~     Fibromyalgia is a common cause of widespread musculoskeletal pain. The investigators have~     found that our patients seem to benefit from a soft tissue physical therapy called~     neurostructural integration therapy (NST). The purpose of this study was to compare NST to~     hydrotherapy which is already used to manage fibromyalgia symptoms.~   "
140728|NCT01725282|"~     In this study, quetiapine XR or placebo will be administered orally for 6 weeks to major~     depressive disorder patients with lack of response to existing antidepressants, with the aim~     of evaluating the efficacy of quetiapine XR and dose-response in three quetiapine XR dose~     groups based on changes in Montgomery-Asberg Depression Rating Scale (MADRS) scores.~   "
140729|NCT01725269|"~     The AIR001-CS05 study evaluated the safety and efficacy (effectiveness) of AIR001 over 16~     weeks in subjects who have PAH. The purpose of the AIR001-CS06 study is to evaluate the~     intermediate / long-term safety of AIR001 in subjects who have completed the AIR001-CS05~     study. Assessments to evaluate the effectiveness of the study drug will include measurements~     of exercise ability and evaluations of PAH disease symptoms.~   "
140730|NCT01725256|"~     The purpose of this study is to evaluate the safety and effectiveness of an~     investigational/experimental drug called AIR001.~      To test the effectiveness, the study will evaluate how AIR001 affects the blood vessels in~     the lungs and the function of the heart. This will be done by monitoring changes in Pulmonary~     Vascular Resistance (PVR); from Baseline/Day 1 (start of study drug) to Week 16 of the study.~     PVR measures the resistance to flow in the blood vessels of the lungs. The study will include~     other assessments to evaluate the effect of the study drug on PAH, including measurements of~     exercise ability and evaluations of PAH disease symptoms.~   "
140731|NCT01725243|"~     In 2009, the Society of Obstetricians and Gynecologists Canada, which produces national~     clinical guidelines on important women's health issues, recommended that a bolus of~     carbetocin 100 mcg into your vein should be used at elective cesarean delivery instead of~     oxytocin infusion for the prevention of bleeding after you deliver your baby. Similar to~     oxytocin, carbetocin has side effects that are dose-related. Although 100 mcg has been the~     recommend dose, studies in nonlaboring women suggest that doses lower than 100 mcg may be~     used to achieve the same degree of uterine contractility with less side effects. So far, the~     ideal dose to be used in cesarean sections for labouring women who have failure to progress~     in labour (failure of your cervix to dilate adequately to 10cm or the baby's head not~     descending the birth canal) has not been determined. This study is designed to determine the~     minimum carbetocin dose required during cesarean delivery for 'failure to progress' to~     achieve the best effect.~   "
140732|NCT01725230|"~     A study to Assess the Pharmacokinetics of Rosuvastatin and Simvastatin when administered~     alone or in combination with Fostamatinib.~   "
140733|NCT01725217|"~     To evaluate the immune response and safety following a single dose of Novartis Meningococcal~     ACWY conjugate vaccine (MenACWY-CRM) in healthy children, adolescents and adults in Russia.~   "
140754|NCT01724944|"~     The purpose of this study is to determine the role of lymphadenectomy in advenced ovarian~     cancer patients at the time of interval debulking surgery after neoadjuvant chemiotherapy.~      Moreover it is a prospective trial, aimed to investigate the prognostic role of sistematic~     lymphadenectomy in terms of percentage of micrometastases detected, morbidity (complications~     rate), progression free interval, overall survival, recurrence pattern.~   "
140755|NCT01724931|"~     The purpose of this study is to determine whether aminopterin is effective in the treatment~     of rheumatoid arthritis (RA).~   "
140734|NCT01725204|"~     Patients with newly diagnosed CML have excellent outcomes with tyrosine kinase inhibitors~     (TKI). However, a few patients will be cured with TKIs alone, and thus need continued~     life-long treatment. Some patients achieve complete molecular remission (CMR), and this rate~     is higher with second generation TKIs compared with imatinib. Some experience with drug~     discontinuation in CMR has been derived from a few small studies, most notably the French~     STIM study. Approximately 40 % of patients with a minimum of two years in MR4.5 (4.5 log~     reduction in molecular response) can stop imatinib without relapse, indicating possible cure.~     To increase the non-relapse rate is of major importance. To achieve a permanent cure~     without stem cell transplantation is presently the most relevant goal of clinical studies in~     CML.~      The investigators hypothesize that to significantly increase cure rates in CML, therapy~     should eradicate leukemic stem cells and/or induce or restore anti-CML immunity. Second~     generation TKIs may have a more profound effect on the stem cell pool as compared to~     imatinib. This is assessed in our current randomized study with a reduction in leukemic stem~     cell burden as the primary endpoint (NordCML006). Interferon-alpha (IFN) has a prominent~     immunomodulatory and antiproliferative mode of action, and has also activity in stem cells.~     Pegylated IFN in combination with imatinib results in improved therapy responses as compared~     to imatinib monotherapy. This advantage may translate into higher cure rates.~      Dasatinib has a unique dual mechanism of action: it is the most potent of available TKIs and~     induces immunological effects that are different from those of IFN. Both of these drugs may~     have immunological adverse-effects when used as a monotherapy. However, immunological~     adverse-effects may also be markers of anti-leukemia efficacy. A combination of dasatinib and~     pegylated IFN (PegIFN) may have additive or synergistic effects and should be tested in a~     clinical study.~   "
140735|NCT01725191|"~     This phase I trial studies the side effects and best dose of tivantinib in treating younger~     patients with solid tumors that have returned after a period of improvement or have not~     responded to treatment. Tivantinib may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth.~   "
140736|NCT01725178|"~     Train The Brain is aimed at assessing the efficacy of cognitive and physical training in~     slowing progression to dementia in patients diagnosed with mild cognitive impairment (MCI).~   "
140737|NCT01725165|"~     The goal of this clinical research study is to learn if surgery or radiation after~     chemotherapy can help to control NSCLC. The safety of this treatment will also be studied.~   "
140738|NCT01725152|"~     This Phase 2 proof-of-concept study is a double-blind, randomized, placebo-controlled,~     crossover study to investigate ganaxolone treatment in children with fragile x syndrome~     (FXS). Up to 60 subjects (ages 6-17 yrs) will be randomized to receive either ganaxolone or~     placebo for 6 weeks and then cross over to the opposite treatment for another 6 weeks. The~     aim of the study is assess the safety, tolerability and efficacy of ganaxolone for treatment~     of anxiety and attention in subjects with FXS. The hypothesis is that ganaxolone treatment~     compared to placebo will improve anxiety and attention as measured by the several~     neuropsychological and psychometric tests.~   "
140739|NCT01725139|"~     This is a dose escalation/dose finding, double-blind, placebo-controlled, parallel study of~     GSK2126458 in subjects with IPF. The study is designed to explore a number of doses of~     GSK2126458 for engagement of pharmacology after short term dosing. It is anticipated that~     approximately 24 subjects will be enrolled in this study. Actual number of cohorts in this~     study could vary up to a maximum of 6 cohorts (n=4/cohort; 3 on active and 1 on placebo).~      Each cohort will consist of four subjects who will be randomised to receive GSK2126458 (three~     subjects) or placebo (one subject) for approximately 8 days (7 to 10 days). On Day 1 they~     will receive their first dose of GSK2126458 (or placebo) and safety, tolerability and PK/PD~     in the blood will be measured for up to 8 hours post-dose. Subjects will then be discharged~     from the site with study drug until the last day of dosing. They will also receive hand held~     spirometers and instructions on action to be taken in case of deterioration in pulmonary~     function or any other adverse events (AEs). On the last day of dosing they will return to the~     site for a repeat of the Day 1 procedures.~      A bronchoalveolar lavage (BAL) and [18F]-fluoro-deoxyglucose (FDG)- positron emission~     tomography / computed tomography (PET/CT) scan will be conducted twice during the study;~     once, at least 2 days before dosing commences and again during the course of the dosing~     period.~      After the final subject in each cohort has completed dosing, a dose escalation meeting will~     take place. Safety and tolerability and PK data will be reviewed during this meeting and~     decisions made may include but are not limited to: escalate the dose, decrease the dose or~     repeat the same dose in the next cohort; stop the study.~   "
140740|NCT01725126|"~     This study is the first administration of GSK2890457 in humans. The study will be conducted~     in 3 parts: - Part A (conducted at a single investigative site) will determine the safety and~     tolerability of GSK2890457 alone in healthy subjects during six weeks of dosing, as well as~     evaluating the potential for a pharmacokinetic interaction with metformin. Part A consists of~     Screening, Treatment (6 weeks) and Follow-up periods. - Part B (conducted at multiple sites)~     will determine safety, tolerability, and pharmacodynamics (PD) in subjects with Type 2~     diabetes (T2D) when co-dosed for six weeks with liraglutide (Victoza). Part B consists of~     Screening, Run-in (1 week), Stabilization (12 weeks), Treatment (6 weeks) and Follow-up~     periods. - Part C (conducted at multiple sites) will determine safety, tolerability, and PD~     in subjects with T2D when co-dosed for 6 weeks with metformin. Part C consists of Screening,~     Run-in (1 week), Stabilization (12 weeks), Treatment (6 weeks) and Follow-up periods.~   "
140741|NCT01725113|"~     The purpose of this non-inferiority study is to compare the safety and effectiveness of a~     mineral and bone disease treatment protocol based on calcitriol to one based on paricalcitol~     in hemodialysis patients using revised Kidney Disease: Improving Global Outcomes (KDIGO)~     parathyroid hormone targets.~   "
140756|NCT01724918|"~     The purpose of this study is to evaluate the effect of different intravenous doses (IV) of a~     new anti-epileptic drug (AED) called lacosamide on continuous EEG (electroencephalogram)~     rhythms (or brain rhythms) in subjects with focal seizures and the tolerability of those~     doses by patients. In addition, this study will assess the effect of IV lacosamide on EKG~     (electrocardiogram), a test which checks for problems with the electrical activity of the~     heart.~   "
140757|NCT01724905|"~     Individuals with intellectual developmental disabilities (IDD) have obesity rates that exceed~     those in the general population, consume energy dense diets, and perform very little physical~     activity (PA). Overweight and obesity are independent risk factors for chronic disease such~     as cancer, diabetes, hypertension, and cardiovascular disease in both the general population~     and those with IDD.~      The investigators modified the Stop Light Diet (SLDm) to include reduced energy pre-packaged~     meals (PM) for 6 months, encouraged consumption of low energy shakes and 35 fruits and~     vegetables (F/V) per week. The investigators will compare participants who use the SLDm with~     participants who use a reduced energy and fat diet with meal plans, based off of the current~     American Dietetic Association recommended car for weight reduction plan.~   "
140742|NCT01725100|"~     This is an open-label, randomized, single-dose, 2-treatment, 2-period, 2-way crossover study~     with incomplete wash-out in subjects with solid tumors to determine the relative~     bioavailability of test formulation with lower dimethyl sulfoxide (DMSO) content as compared~     with standard reference formulation trametinib.~      Approximately 18 subjects will be randomized to receive either a single dose of Treatment A~     (standard target DMSO content [theoretical 11.3%] formulation of GSK1120212B) or a single~     dose of Treatment B (lower DMSO Content [approximately 9.5%] formulation of GSK1120212B)~     followed by a 7 day incomplete wash-out period, then a single dose of the other treatment.~      Administration of the dose under fasted conditions in Periods 1 and 2 will be only on Day 1~     followed by 7 days of serial blood sampling for PK analysis of plasma trametinib. Safety~     assessments, including assessment of AEs, clinical laboratory (hematology and clinical~     chemistry) and vital signs, will be made throughout the study.~      After a subject completes the study, he or she may be eligible to enter study MEK114375, an~     open-label rollover study of trametinib (no wash-out period or follow-up visit required) and~     continue receiving trametinib. For those subjects who wish to discontinue or complete the~     current study and choose not enter the rollover study, a follow-up visit should be performed~     within 21 days after receiving the last dose of study treatment.~   "
140743|NCT01725087|"~     The purpose of this trial is to evaluate the safety and efficacy of once daily orally~     administered GRT6005 in a total of 3 fixed doses compared to placebo in subjects with~     moderate to severe chronic Low Back Pain (LBP). The study includes a maximum of 21 days~     screening period followed by a 2-week titration period and 12-week maintenance double-blind~     treatment period and a 10-14 day safety follow up period. Patients who are eligible for the~     double-blind treatment period will be randomized to one of the following treatment groups:~     GRT6005 low-dose, GRT6005 medium dose, GRT6005 high-dose, Tapentadol or placebo.~   "
140744|NCT01725074|"~     This randomized controlled trial (RCT) will examine a case management program for patients~     suffering from coronary heart disease with multimorbidity in Mannheim, Germany. The trail~     consists of 3 treatment arms: 1) intensified case management; 2) social interaction alone 3)~     standard care. The main objectives are to evaluate how case management and social interaction~     alone compared to standard medical care affect the primary and secondary outcomes: physical~     health, quality of life, loneliness, depression, self-efficacy, outcome expectancies, social~     support, health locus of control, lifestyle behavior, social network, vulnerability,~     intention, severity, health worries and cognitive functions.~   "
140745|NCT01725061|"~     Acute lung injury (ALI) is an often deadly form of respiratory failure caused by~     inflammation. The widespread injury to the lungs involves a build-up of fluid in the lungs~     that results in damage to the lungs and a decreased ability of the lungs to function~     properly. There is currently no specific treatment for ALI; and of the 200,000 cases reported~     in the US yearly, about 40% will die.~      Some patients may have other conditions that could change the risk of developing ALI. For~     example, it has been reported that patients who have septic shock have a lower chance of~     developing ALI if they also have diabetes mellitus (diabetes). Septic shock is a type of~     infection that causes overwhelming inflammation to occur throughout the body; it increases~     the chances that a person will develop ALI.~      The reason diabetics are less likely to develop ALI is unclear and deserves further~     investigation. The investigators believe that it may be explained by differences in the way~     certain cells that are involved in inflammation function in the lungs. The investigators plan~     on looking at the relationship between the wide-spread inflammation that occurs within the~     bodies of diabetic and non-diabetic patients with an increased chance of developing ALI~     [sepsis].~      To study this relationship, we will identify patients who fit the requirements of the study.~     The investigators will obtain blood samples and lung washings from these patients. The lung~     washings will be obtained by injecting clean salt water into the lungs through a tube and~     then pulling the water back out. When the sterile water is removed, some cells from the lungs~     also are removed and they can then be used for further lab studies. Determining how diabetes~     may change a patient's chance of developing ALI may uncover useful information that may help~     prevent or treat ALI in all patients at risk.~   "
140746|NCT01725048|"~     This is a pilot study to test the hypothesis that the antidepressants mirtazapine and~     citalopram are effective treatment for major depressive disorder (MDD) in cancer patients.~   "
140747|NCT01725035|"~     Nonalcoholic Fatty Liver Disease (NAFLD) is becoming the most common cause of liver disease~     in pediatrics, but little is known about its pathophysiology in children. While studies in~     obese adults with hepatic steatosis have described an increased hepatic de novo lipogenesis~     (DNL) depending on the diet, there are no studies exploring the mechanisms by which excess~     hepatic triglycerides increases in obese youths, thus explaining the accompanying~     dyslipidemia and the metabolic syndrome. The central hypothesis of this study is that hepatic~     conversion of carbohydrates to lipid (DNL) is enhanced and associated with accumulation of~     excess liver fat, dyslipidemia and hepatic insulin resistance in obese youths with hepatic~     steatosis. The overall goal is to examine whether hepatic DNL is increased in obese youths~     with steatosis compared to matched controls without steatosis.~      Hypotheses: Hepatic conversion of carbohydrates to lipid (DNL) is enhanced and is associated~     with accumulation of excess liver fat, dyslipidemia and hepatic insulin resistance in obese~     youths with hepatic steatosis.~   "
140748|NCT01725022|"~     The primary goal with this study is to document whether patients can maintain their normal~     bowel microbiota by staying at home compared to those who live at home but are treated in~     clinic, and those who are treated in the hospital. In addition, the investigators would~     predict that the quality of life will be higher for those patients treated at the medical~     home compared to those that stay at the hospital. The investigators also predict that the~     costs associated with this approach will be significantly lower compared to hospitalized~     patients. Finally, the investigators propose that the treatment related morbidities and~     mortality will not be different between the two groups.~   "
140749|NCT01725009|"~     To compare the pharmacokinetics of levetiracetam following single and multiple 15-minute~     intravenous infusions of 1500 mg levetiracetam between Japanese and Caucasian healthy male~     subjects~   "
140750|NCT01724996|"~     To determine the significance of a simple bedside clinical test (chest wall tenderness) to~     exclude myocardial ischemia in different demographic groups.~   "
140751|NCT01724983|"~     Ketamine may improve recovery from bariatric surgery.~   "
140752|NCT01724970|"~     Obese people pose specific problems as far as the management of airway during surgery. The~     study aims to compare efficacy and safety of two LMA devices.~   "
140753|NCT01724957|"~     The study hypothesis: it is possible to use icECG recorded from regular PCI wire to predict~     significance of SB ostial stenosis after main vessel stenting in coronary bifurcation~     lesions.~   "
140832|NCT01723904|"~     This study is to investigate the safety and efficacy of Rotigotine add-on therapy with low~     doses of Pramipexole or Ropinirole in patients with advanced-stage Parkinson's Disease (PD)~     who have insufficient response to L-dopa and low doses dopamine receptor agonists.~   "
140758|NCT01724892|"~     Corticosteroid has been used for the treatment after phototherapeutic keratectomy (PRK).~     Dexamethasone, a potent steroid can retard the corneal epithelial healing rate and has~     numerous serious complications, especially glaucoma. Loteprednol, a new generation of~     corticosteroid has less potency than dexamethasone and was proposed to has less side effect~     regarding intraocular pressure (IOP) elevation. Therefore, Investigators would like to~     compare the effect of dexamethasone and loteprednol on corneal epithelial healing rate after~     PRK and risk of glaucoma.~   "
140759|NCT01724879|"~     The current standard treatment approach for young patients with Positive Acute Lymphoblastic~     Leukemia (Ph+ALL) is the combination of a chemotherapy protocol employing four to five~     cytotoxic agents typically used for ALL together with imatinib. It is recommended to propose~     allogeneic Standard Induction and Consolidation Therapy (SCT) to all eligible patients with a~     suitable donor and to continue imatinib with or without additional therapy in patients not~     undergoing SCT.~      This protocol is a study for newly diagnosed Philadelphia chromosome positive acute~     lymphoblastic leukemia in patients aged 18 to 55 years.~      The objective of this strategy is to improve the overall results in the treatment of adult~     ALL with the addition of specific molecules to the common chemotherapeutic schedule.~   "
140760|NCT01724866|"~     The purpose of this study is to assess the effect of test doses of HM10460A on the duration~     of severe neutropenia (DSN) during Cycle 1 in patients with breast cancer who are candidates~     for adjuvant or neoadjuvant chemotherapy.~   "
140761|NCT01724853|"~     The main objective of the study is the evaluation of the outcomes following treatment for TMC~     OA using a set of variables covering all OMERACT categories as well as the dimensions of the~     International Classification of Functioning, Disability and Health (ICF). Secondary aims are~     the analysis of the determinants of patient satisfaction with the treatment result, the~     evaluation of the psychometric properties of the Michigan Hand Outcomes Questionnaire (MHQ),~     which has not yet been established in TMC OA patients, as well as the economic impact~     associated with TMC OA.~   "
140762|NCT01724840|"~     Studies at the shoulder, Achilles tendon and thumb show satisfactory results regarding the~     use of GaftJacket. Initial trials at the thumb show, that the GraftJacket can be safely and~     successfully used in TMC OA surgery and therefore represents an acceptable alternative for~     avoiding possible donor-site morbidity. However, there are no randomised controlled trials~     (RCT) in which the outcomes of using a tendon interposition or the GraftJacket are compared.~     Only with an RCT design it is possible to gain evidence about the advantages of one treatment~     method over another. The main objective of the study is the comparison between two surgical~     techniques for TMC OA: The resection interposition suspension arthroplasty using a part of~     the flexor carpi radialis tendon as interpositional material and using the GraftJacket as~     interpositional material.~   "
140763|NCT01724827|"~     The main purpose of this trial is to determine which material, between ceramic and composite,~     is best to manufacture dental inlays and onlays in the treatment of moderate dental substance~     losses, generally due to dental caries. Restorations will be done using direct Computer~     Assisted Design and Manufacturing (CAD-CAM). Another aim of this study is to determine which~     factors influence the success of these restorations.~   "
140764|NCT01724814|"~     Study Design:~      Part 1.Randomized, double-blind, placebo-controlled, escalating single-dose design with~     Healthy volunteers Part 2.Open , sequential, two-period, single dose study with type 1~     diabetes Part 3.Open, sequential, two-period, single dose study with type 2 diabetes~   "
140765|NCT01724801|"~     EGFR-TKI is good for the patients with EGFR-mutant non-small cell lung cancer.We design this~     clinical trail to confirm if the efficacy of Epidermal Growth Factor Receptor Tyrosine Kinase~     Inhibitor(EGFR-TKI )(ICOTINIB) is better than whole brain irradiation for the patient with~     EGFR-mutant non-small cell lung cancer.~   "
140766|NCT01724788|"~     Primary Objective:~        -  To determine the absolute bioavailability of furosemide 500 mg (Lasix® Special) oral~          formulation in patients with chronic renal failure undergoing peritoneal dialysis.~      Secondary Objectives:~        -  To determine the pharmacokinetic profiles of furosemide 500 mg (Lasix® Special) oral~          formulation and 250 mg IV formulation~        -  To compare the pharmacodynamic characteristics of furosemide 500 mg (Lasix® Special)~          oral formulation and 250 mg IV formulation~   "
140767|NCT01724775|"~     In 2009, Prof. Hohenberger proposed complete mesocolic excision (CME) as standardized, in~     which the same principle of TME in rectal cancer has been applied to the colon. More and more~     surgeons pay attention to the rationality of this surgical approach. However, the clinical~     application researches are still few, in particular the prospective controlled study is still~     none. This clinical trial will compare the CME group and non-CME group to evaluate the~     outcome and safety of CME for apply in clinic.~   "
140768|NCT01724762|"~     This study's general objective was to evaluate the efficacy of nursing orientation to reduce~     the anxiety of patients with acute coronary syndrome undergoing bed bath. The specific~     objectives included: the development and validation of an informative manual concerning bed~     bath; correlation of physiological variables (systolic and diastolic blood pressure and heart~     and respiratory rate) with the patients' state anxiety; correlation of antecedent variables~     (age, gender, cardiovascular risk factor, use of beta blockers, trait anxiety, depression,~     prior hospitalization, prior experience with bed baths, the patients' preference for a female~     or male professional to perform the bath, pain, fear, and embarrassment) with the patients'~     state anxiety.~   "
140769|NCT01724749|"~     The purpose of the CAMONA study is to demonstrate the feasibility of cardiovascular molecular~     calcification (CMC) assessment by means of 18F-sodium-fluoride (18F-NaF) positron emission~     tomography (PET) computed tomography (CT) in a prospective cohort of healthy control subjects~     and subjects with cardiovascular disease.~   "
140770|NCT01724736|"~     This study aims to investigate the effect of a cobiotic formulation, prepared as a smoothie~     beverage, on the ratio of intestinal microbiota of the Bacteroidetes phylum to those of the~     Firmicutes phylum in the stool as well as the effect on insulin resistance, gut hormones~     (PYY) Peptide YY and (GLP-1) Glucagon-like Peptide, ghrelin with perceptions of appetite and~     satiety.~   "
140833|NCT01723891|"~     Study to compare safety and pharmacokinetic properties of surfolase capsule and HT-002-01~     after oral administration for one day in healthy male volunteer.~   "
141124|NCT01720095|"~     The purpose of this study is to help understand if by adding Niaspan FCT (study drug) to~     antipsychotic medications will it help maintain or improve cognitve functioning.~   "
140771|NCT01724723|"~     Hepatitis during anti-tuberculous treatment (HATT) has been an obstacle in managing TB~     patients, especially in those with viral hepatitis. A previous study revealed the risk of~     HATT is significantly higher in TB patients with high serum hepatitis B virus (HBV) DNA level~     than those with low HBV DNA level. Based on these findings, we thus hypothesize that the risk~     of HATT in TB patients with high baseline serum HBV DNA level can be reduced by concomitant~     use of anti-HBV agent. In this proposal, we will conduct a prospective randomized clinical~     study to assess the reduction of HATT risk by using entecavir in TB patients with high~     baseline serum HBV DNA level, and to evaluate the risk of other treatment-related adverse~     events in two hospitals.~   "
140772|NCT01724710|"~     Chronic ulcers is a common clinical problem. Diabetes or peripheral vascular occlusion is~     major reason leading to chronic wound healing.~      The investigators's previous animal experiments have confirmed that OLED can promote burn~     wound healing and fibroblast proliferation in normal Wistar rat.~      In order to find the time point and dosage of the effective light therapy. The investigators~     further use cultured human fibroblasts in vitro to study light therapy to promote fibroblast~     proliferation mechanisms.~      Expect clinical application of light therapy in the future is more accurate and effective.~   "
140773|NCT01724697|"~     HBV related Liver disease is a common medical problem in China. An estimated 7.18% of the~     Chinese (about 93 million) is infected with hepatitis B, and most of the HBV- related~     hepatitis can developed into liver cirrhosis.~      Liver transplantation is the only available life saving treatment for patients with end stage~     liver disease. However, lack of donors, surgical complications, rejection, and high cost are~     serious problems.~      stem cells(SCs) possess plasticity and have the potential to differentiate into hepatocyte;~     Thus, SCs hold great hope for therapeutic applications. Adult bone marrow is the most common~     source of SCs for clinical applications.Previous study showed that bone marrow derived stem~     cells (BMSCs) replace hepatocytes in injured liver, and effectively rescue experimental liver~     failure and contribute to liver regeneration. In this study, the patients with HBV-related~     liver cirrhosis will undergo administration of human autologous BMSCs via hepatic artery to~     evaluate the safty and efficacy of human autologous BMSCs treatment for these patients.~   "
140774|NCT01724684|"~     Recent studies have demonstrated the promising potential that telehealth has in management of~     chronic disease. For COPD patients, implementation of telehealth reduced readmissions,~     emergency room visits, and exacerbations and was cost-effective. Telehealth as a method of~     delivering healthcare to remote, resource-deprived areas is not lacking in evidence of~     benefit; however, the situation about its more widespread use for monitoring purposes is much~     less clear. To date, most of the studies dealing with telehealth in COPD were conducted in~     countries covering vast territories. Therefore, it needs to be investigated whether~     telehealth conveys similar advantages for COPD patients in a small island country.~   "
140775|NCT01724671|"~     To compare the time to pathogen eradication, and the relationship to the time to clinical~     improvement, between ceftaroline and case-matched vancomycin treated controls in the~     treatment of adults with serious infections caused by Methicillin-Resistant Staphylococcus~     aureus (MRSA).~   "
140776|NCT01724658|"~     Additional testosterone undecanoate can improve female sexual function in postmenopausal~     women which one aspects of quality of life. The dose adjustment can reduce incidence of~     adverse effects and low cost of treatment with effective outcome.~   "
140777|NCT01724645|"~     This trial is being conducted to look for following changes when Korean traditional diets is~     taken in subjects with hypertension and type 2 diabetes:~      To evaluate the improvement of the controlling fasting blood glucose and glycated hemoglobin.~      To assess the controlling blood pressure and heart rate.~      To evaluate the influence on cardiovascular risk factor, Triglyceride, cholesterol, High~     Density Lipoprotein-cholesterol and Low-Density Lipoprotein-cholesterol.~      To evaluate the influence on Gamma-Glutamyl Transpeptidase.~      To evaluate the influence on Cardiovascular risk factor.~      To evaluate the influence on valsava score, breathing score and upright score.~   "
140778|NCT01724632|"~     The purpose of this study is to compare three methods of delivering behavioral weight loss~     treatment.Participants are randomly assigned to one of three 18-month weight loss treatments~     (group, individual, or smartphone treatment). Participants who are assigned to group~     treatment will attend group meetings weekly for the first 6 months, then every 2 weeks for 6~     months, and then monthly for the final 6 months. Participants who are assigned to individual~     treatment will attend one-on-one sessions with a weight loss counselor every month for 18~     months. Participants who are assigned to smartphone treatment will use a smartphone to learn~     and practice weight loss skills. They will also attend one-on-one sessions with a weight loss~     counselor every month for 18 months. Assessment visits are conducted at baseline, 6, 12, and~     18 months.~   "
140779|NCT01724619|"~     Prostate cancer represents a significant health problem in the United States. This year~     179,000 men in the United States will be diagnosed with prostate carcinoma and approximately~     25% of them will die of the disease. In addition, the incidence and mortality of prostate~     carcinoma has been increasing steadily in the United States. Prostate-specific antigen (PSA)~     levels are commonly used as a biomarker for the detection of prostate cancer. Nonetheless,~     there is a significant false negative and false positive diagnosis since PSA levels elevate~     in benign prostatic hyperplasia and prostatitis and decrease in patients taking medications~     and herbal remedies. Twenty percent of biopsy-proven prostate carcinoma have PSA levels~     within the normal range, thus confounding the diagnosis based on the PSA screening test.~     Current diagnostic methods that include transrectal ultrasound (TRUS) and TRUS guided~     prostate biopsy are logistically difficult and insensitive. These are further complicated by~     equivocal prostatic biopsy findings such as prostatic intraepithelial neoplasia (PIN) or~     normal PSA with high clinical suspicion. A tracer with high specificity to prostate cancer~     related structures at a cellular level would enhance our understanding of the pathophysiology~     of prostate cancer and would contribute to the detection, localization and quantification of~     the disease and its metastases. This information will be invaluable in selecting the~     appropriate treatment regimen.~      This study will test the utility of [F-18]FMDHT to image prostate cancer and will evaluate if~     this radiotracer can differentiate primary prostate cancer in the prostate gland from normal~     prostate gland itself. More specifically, we will study the distribution kinetics of~     [F-18]FMDHT in normal healthy humans and in patients with prostate cancer.~      As per exploratory IND requirements, we performed toxicity assessment of FMDHT through an~     outside laboratory (ILS, Inc.) and the results of that study are attached as Appendix A.~      Based on our and others data, we hypothesize that:~        1. [F-18]FMDHT PET/CT will distribute initially in various normal tissues following blood~          flow pattern and will clear rapidly from tissues with no AR.~        2. [F-18]FMDHT PET/CT will detect metastatic disease that expresses AR.~        3. [F-18]FMDHT PET/CT uptake will be elevated in AR-expressing prostate cancer lesions~          compared to surrounding normal prostate.~      In order to progress [F-18]FMDHT into clinic, we are performing a pilot 'first-in-human'~     biodistribution study in subjects with and without prostate cancer.~   "
141366|NCT01716923|"~     The clinical study will assess the in-vitro characteristics of red blood cells (RBCs) per the~     European Union (EU) criteria for leukocyte depleted RBCs in additive solution and evaluate~     the safety and efficacy of S-303 treated RBCs in a patient population requiring RBC~     transfusion support for acute anemia.~   "
140780|NCT01724606|"~     Sorafenib is a new type of anti-cancer drug. It belongs to a new class of medications known~     as tyrosine kinase inhibitors. Sorafenib is thought to work against cancer in many ways. It~     helps decrease blood supply to the tumor. It also blocks some proteins that help the tumor~     cells to grow. Sorafenib is approved by the Food and Drug administration (FDA) for treatment~     for other cancers like liver and kidney cancer. Sorafenib has also been studied in the~     treatment of breast cancer that has spread but is not specifically approved for the treatment~     of breast cancer. It has been studied both as a single agent and also in combination with~     other anti-cancer therapies for breast cancer. In laboratory models and in some patients with~     other cancers, sorafenib has been studied in tumors in the brain.~      In this study, sorafenib will be given together with whole brain radiation therapy (WBRT).~     Overall this research study is designed to answer 2 main questions:~        1. What dose of sorafenib should be used together with WBRT?~        2. What are the side effects of sorafenib and WBRT when given together?~   "
140781|NCT01724593|"~     Intensive Care Unit-acquired weakness (ICU-AW) is a well-recognized, important and~     preventable sequelae of critical illness, affecting up to 60% of adult ICU patient. ICU-AW is~     associated with increased mortality and length of stay, and negatively impacts long-term~     functional outcomes and quality of life in affected patients and their caregivers. While~     delayed mobilization adversely affects clinical outcomes, early rehabilitation in the~     critically ill adult population is safe, feasible, cost effective, results in more ventilator~     free-days and better functional outcomes at hospital discharge. In contrast, there is a~     paucity of this research in pediatrics. Our research suggests that immobilization is common~     in critically ill children, and rehabilitation is delayed particularly in the sickest~     children who are arguably at highest risk of morbidity. It is unclear however, whether~     delayed rehabilitation leads to adverse outcomes in critically ill children, as has been~     demonstrated in adults. Our objectives of this study are to evaluate if immobilization and~     delayed rehabilitation negatively impacts short-term clinical outcomes and the time to~     functional recovery in critically ill children. The investigators hypothesize that the~     following factors may influence functional recovery and morbidity in critically ill children:~        -  Pre-morbid condition~        -  Age~        -  Time-to-initiation of acute rehabilitation~        -  Critical illness disease severity~   "
140782|NCT01724580|"~     The Requesting Physician/Investigator contacts Lilly when, based on their medical opinion, a~     patient meets the criteria for inclusion in the expanded access program.~   "
140783|NCT01724567|"~     The purpose of the study is to make a head-to-head comparison of weight loss and interval~     training as methods of secondary prevention in overweight patients with ischemic heart~     disease.~   "
140784|NCT01724554|"~     The purpose of this study is to look at how effective, safe, and well tolerated Intravitreal~     Aflibercept Injection is in subjects with Central Retinal Vein Occlusion (CRVO) or~     Proliferative Diabetic Retinopathy (PDR).~   "
140785|NCT01724528|"~     The purpose of this study is to determine whether febuxostat is superior to allopurinol in~     the prevention of tumor lysis syndrome (TLS) in patients with hematological malignancies at~     intermediate or high risk of TLS (according to Cairo-Bishop classification) who undergo~     chemotherapy~   "
140786|NCT01724515|"~     The purpose of this study is determine if you have too much fat in your body that it will~     decrease the conversion of food energy into energy that your body can use.~   "
140787|NCT01724502|"~     The purpose of this study is to determine whether insulin resistance is accompanied by~     exercise resistance. Investigators will use mass spectrometry and proteomics analysis to~     test the hypothesis is that a bout of exercise that increases mitochondrial protein abundance~     in lean, healthy individuals is less effective in insulin resistant patients.~   "
140788|NCT01724489|"~     Obesity is an important risk factor for osteoporosis and fractures. With the growing~     prevalence of obesity in the U.S., understanding the pathophysiology of bone loss in this~     population is of importance to public health. Growth hormone (GH) is a critical mediator of~     bone homeostasis and is markedly reduced in obesity. Our preliminary data suggest an~     important role for the GH/insulin-like growth factor 1 (IGF-1) system in the pathogenesis of~     bone loss in obesity. The development of novel imaging techniques provides an opportunity to~     investigate the effects of GH on skeletal structure and strength, which will provide insights~     into the pathogenesis of obesity related bone loss. Understanding the pathophysiology of bone~     loss in obesity may help identify new treatment targets for this important complication. The~     investigator hypothesizes that low-dose GH administration for 18 months will improve skeletal~     health.~   "
140789|NCT01724476|"~     The investigators propose to conduct a randomized Sequential Parallel Design for Double-Blind~     Phase fixed dose, 4-month trial of folate plus B12 as add-on therapy in 200 Ethiopian~     subjects with schizophrenia with stable residual positive or negative symptoms.~   "
140790|NCT01724463|"~     Thousands of children die from Sepsis following routine infections. Many of these deaths can~     be prevented with earlier recognition and focused management. No tools are currently~     available to recognize the signs of early sepsis in children. The investigators have~     developed a electronic health record-based tool that will recognize children with sepsis~     early and trigger an alert to their hospital caregivers. The caregivers will be prompted to~     launch a focused management bundle that can stabilize these children, prevent further~     deterioration and reduce their chances of sepsis related complications and death. The~     proposed study will test the validity and effectiveness of this electronic tool in reducing~     sepsis mortality rates.~   "
140791|NCT01724450|"~     The purpose of this study is to evaluate if carvedilol can prevent the cardiotoxicity after~     chemotherapy in breast cancer.~   "
140792|NCT01724437|"~     The aim of the study was to assess the near-term (12 months) efficacy of pulmonary vein~     isolation using a standard approach compared to application of an additional acute procedural~     endpoint of unexcitability along the ablation line.~   "
140834|NCT01723878|"~     This observational study will evaluate the patterns of disease progression in patients with~     locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring EGFR activating~     mutations receiving Tarceva (erlotinib) as first-line treatment. Patients will be followed~     for up to 12 months after progression of disease.~   "
142017|NCT01708382|"~     Up to 20 subjects will be treated. Treated subjects will receive one Ulthera® treatment on~     the elbows. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will~     be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.~   "
140793|NCT01724424|"~     Antioxidant therapy targeted at mitochondria has the potential to reduce inflammation,~     mitochondrial damage and organ dysfunction in sepsis. Melatonin accumulates in mitochondria~     and both it and its metabolites have potent antioxidant and anti-inflammatory activity,~     preventing organ dysfunction in a rat model of sepsis. The investigators propose a study in~     healthy volunteers to assess the tolerability and pharmacokinetics of exogenous melatonin and~     its major metabolites and to relate these doses to ex vivo anti-inflammatory and antioxidant~     activities. Groups of healthy subjects will receive increasing sequential doses of oral~     melatonin in an open label dose escalation study. Ex vivo inflammatory responses, oxidative~     stress and mitochondrial function at concentrations of melatonin identified in the dose~     escalation study will be determined following exposure of whole blood to an inflammatory~     insult. This will provide crucial information to inform a subsequent phase II clinical trial~     of melatonin in patients with sepsis.~   "
140794|NCT01724411|"~     The proposed study will address the effect of developed novel food products through~     processing innovation on motivation to eat, biomarkers of satiety, nutrient bioavailability~     and gut health using in vivo studies and validating new in vivo approaches.~      Specifically in this protocol we will address, in a short human intervention study the effect~     of a potentially satiating product on appetite, appetite biomarkers, particularly the~     influence on gut microbiota, tolerance and safety of the products in healthy obese and~     overweight volunteers in free living conditions.~   "
140795|NCT01724398|"~     Liver failure (LF) is a dramatic clinical syndrome with massive necrosis of liver cells.~     Although liver transplantation provides an option to cure patients suffering with LF, lack of~     donors, postoperative complications, especially rejection, and high cost limit its~     application. Previous study showed that bone marrow derived mesenchymal stem cells (BM-MSCs)~     the novel and promising therapeutic strategy, BM-MSCs can replace hepatocytes in injured~     liver, and effectively rescue experimental liver failure and contribute to liver~     regeneration. Plasma exchange (PE) can improve internal environment by removing endotoxin, it~     helps the liver regeneration and functional recovery and make UC-MSC differentiation into~     hepatocyte like cells, and exert immunomodulatory function. In this study, safety and~     efficacy of human umbilical cord mesenchymal stem cells (UC-MSCs) transplantation combined~     with plasma exchange (PE) for patients with liver failure caused by hepatitis B Virus will be~     evaluated.~   "
140796|NCT01724385|"~     To evaluate the efficacy of intravitreal bevacizumab injections for treatment of~     proliferative diabetic retinopathy (PDR) with new dense vitreous hemorrhage (VH) after~     previous full panretinal photocoagulation (PRP).~   "
140797|NCT01724372|"~     This is a randomized, controlled pilot study comparing the antidepressant fluoxetine with the~     second generation antipsychotic aripiprazole in approximately 10 subjects aged 12-25 at risk~     for developing psychosis.~      Our primary hypotheses are that compared to aripiprazole, fluoxetine will be better tolerated~     and will lead to greater improvement in symptoms at the end of 6 months of treatment.~   "
140798|NCT01724359|"~     The purpose of this study is to evaluate efficacy, safety and tolerability of flexible,~     once-daily doses of paliperidone extended-release (ER) in patients with schizophrenia from~     Argentina and Colombia that previously failed treatment with other antipsychotic agents.~   "
140799|NCT01724346|"~     An Open-label Extension Study in Patients 65 Years or Older with Chronic Lymphocytic Leukemia~     (CLL) or Small Lymphocytic Lymphoma (SLL) Who Participated in Study PCYC-1115-CA (PCI-32765~     versus Chlorambucil)~   "
140800|NCT01724333|"~     Assessment of oral and dental problems is seldom routine in clinical oncology, despite the~     potential negative impact of these problems on nutritional status, social function and~     quality of life (QoL). A brief, assessment tool for oral/dental health and related QoL-issues~     to improve symptom management has been requested. The present study will be conducted on~     behalf of and with support from the European Organisation for Research and Treatment of~     Cancer - (EORTC) Quality of Life Group (QLG). The study represents phase IV, the final step,~     in the development of an international, symptom specific questionnaire module, focusing on~     oral and dental problems in relation to cancer and its treatment. Phase I-III of this~     stepwise development process was conducted from 2008 to 2011, as an international~     collaboration and conducted according to the guidelines for module development set forth by~     the EORTC QLG. The resulting module, the QLQ-OH17, is now subject to an international field~     testing and validation study as described in this project description.~      The present version of the QLQ-OH17 consists of 17 items conceptualized into four multi-item~     scales (pain/discomfort, xerostomia, eating and information) and three single items related~     to use of dentures and future worries. The aim of the present study is to conduct phase IV;~     an international field study to confirm the psychometric properties of the QLQ-OH17~   "
140801|NCT01724320|"~     The purpose of this study is to determine the recommended dose (RD) for further phase II~     studies, of the Galectin-1 inhibitor OTX008 given subcutaneously in patients with advanced~     solid tumors~   "
140802|NCT01724307|"~     The purpose of this study is to evaluate if stimulating the nerve involved with airway~     constriction, while undergoing procedures that are known to cause asthma exacerbations,~     decreases the level of asthma attack experienced.~   "
140803|NCT01724294|"~     This multicenter, observational study will evaluate the correlation between clinical and~     biological factors and International Prognostic Index (IPI) as prognostic factors in patients~     with diffuse large B-cell lymphoma receiving first-line treatment with MabThera/Rituxan~     (rituximab) in combination with CHOP chemotherapy. Eligible patients receiving treatment~     according to standard of care and local guidelines will be followed for the duration of~     treatment (approximately 8 months) and during 1 year of follow-up.~   "
140804|NCT01724281|"~     The investigators will follow up on babies that had prenatal diagnosis at 2nd or 3rd~     trimester of normal width and asymetry of lateral brain ventricles~   "
140805|NCT01724268|"~     Compare the efficacy of adding small doses of prednisolone (10 mg) daily to the efficacy of~     adding one of the available anti TNF in the treatment of methotrexate inadequate responder~     rheumatoid arthritis patient.~      Hypothesis:~      Methotrexate + Prednisolone vs. Methotrexate + anti TNF~   "
141159|NCT01719627|"~     Pre-exposure prophylaxis (PrEP) is a method of preventing HIV infection through the use of~     antiretroviral (ARV) medications before exposure to HIV. This study will assess the potential~     of MVC as a on demand pre-exposure prophylaxis, within a strategy for the prevention of HIV~     infection in men who have sex with men (MSM).~   "
140806|NCT01724255|"~     The medical literature does not provide sufficient information or recommendation regarding~     the optimal time to remove the staples and the bandage after a cesarean section. The goal of~     this study is to compare 5 groups of patients:~        1. staple removal on POD 4 and dressing removal on Post Operative Day (POD)1~        2. staple removal on POD 4 and dressing removal on Post Operative Day (POD)4~        3. staple removal on POD 7 and dressing removal on Post Operative Day (POD)1~        4. staple removal on POD 7 and dressing removal on Post Operative Day (POD)7~        5. staple removal on POD 4 and dressing removal on Post Operative Day (POD)7~      Since there is no definite protocol for staple and dressing removal, we will adapt the above~     protocol each for a 3-4 month period of time. Patients will be contacted to either return for~     a follow up visit or to answer a telephone survey.~   "
140807|NCT01724242|"~     There does not appear to be a consensus regarding the treatment of vaginal dryness in women~     who have a contraindication to the use of estrogen products. DHEA, when used locally, may~     improve the symptoms of vaginal dryness due to its chemical properties.~   "
140808|NCT01724229|"~     The purpose of this evaluation is to observe the performance of two (2) different skin care~     treatment protocols on the skin:~      #1 Kendall™ Body Wash & Shampoo in combination with the Moisture Barrier Cream; or #2~     Kendall™ 2-in-1 Cleanser in combination with the Anti-fungal Cream.~      The scientific evidence supports using these types of skin care products to keep the skin~     healthy in the presence of moisture, urine, stool, or fungal infection. The cleansers are~     preferred over soap and water and can be applied on all areas of the skin. The Moisture~     Barrier Cream is formulated especially for skin exposed to moisture, urine, or stool. The~     Antifungal Cream is utilized for fungal infections associated with athlete's foot, jock itch,~     and ring worm to relieve itching, soreness, and irritation.~   "
140809|NCT01724216|"~     The purpose of the study is to collect in vivo human image data to demonstrate neurological~     magnetic resonance imaging (MRI) of subjects using short pulse sequences.~   "
140810|NCT01724203|"~     The purpose of this clinical trial is to evaluate the safety and effectiveness of 12-week~     probiotic supplementation on the incidence and duration of infectious episodes in infants~     aged 6 to 12 months.~   "
140811|NCT01724190|"~     The purpose of this study is to determine if supplementation with Vitamin D in children and~     adolescents with newly diagnosed type 1 diabetes increases the number of patients who enter~     the honeymoon period.~   "
140812|NCT01724177|"~     To evaluate the efficacy of lenalidomide in patients with Adult T-cell Leukemia-lymphoma~     (ATL) who have previously received chemotherapy for ATL.~   "
140813|NCT01724164|"~     The purpose of this proposal is 1) to compare the relative effects of the robotic~     rehabilitation (RR), mirror therapy (MT), and conventional intervention (CI), 2) to compare~     the effects of the combined therapy of the RR-Functional Electrical Stimulation (FES) and the~     RR-Placebo Intervention (PI), and 3) to identify the clinical predictors that will~     potentially influence the functional outcomes after interventions.~   "
140814|NCT01724151|"~     The proposes of this study are~        1. To understand the physical activities of patients with cognitive impairment in Taiwan~          and construct the validity and reliability of the physical activity questionnaire and~          actigram in this population.~        2. To understand the relation between brain structure (brain tractography and resting state~          functional MRI) and cognitive and physical functions of patients with cognitive~          impairment, the capability of activity and social engagement (including quality of~          life).~        3. To understand the efficacy of exercise on the brain structure (brain tractography and~          resting state functional MRI), cognitive and physical functions, the capability of~          activity and social engagement (including quality of life) of the patients with~          cognitive impairment.~      The study aims to establish the data base of physical activity of patients with cognitive~     impairment in Taiwan. We will also analyze the efficacy of exercise with ICF model on~     physical function, physical activity and social engagements to provide an optimized design of~     exercise program for patients with cognitive impairment in the future.~   "
140815|NCT01724138|"~     To characterize the PK of deferasirox in pediatric β-thalassemia major patients aged from 2~     to less than 6 years old, when administrated with a fixed starting dose of 20 mg/kg/day.~   "
140816|NCT01724125|"~     Electronic Personal Health Records (PHRs) hold promise in helping reshape healthcare by~     shifting the ownership and locus of health records from being scattered across multiple~     providers to an approach that is longitudinal and patient-centered. Given the complex health~     needs and the fragmentation of care for persons with serious mental illnesses, these~     individuals could derive particular benefit from a PHR. However, there are currently no~     established PHRs developed for use in this population.~      In order to fill this gap, the investigators propose to develop, test, and disseminate a~     Personal Health Record for persons with serious mental illnesses and one or more comorbid~     medical condition. The Mental Health PHR (MH-PHR) builds on an established personal health~     record which was developed in partnership with medical consumers and is in wide use in a~     number of communities in the United States and abroad.~   "
140817|NCT01724112|"~     This study will determine the efficacy, safety, and tolerability of a 40 milligrams (mg)~     once-daily (QD) dose of LY2940094 for 8 weeks in participants with MDD.~   "
140818|NCT01724099|"~     The hypothesis of this study is obese patient with Euiiyin-tang for 12 weeks will show a~     superior reduction compared to those taking the placebo.~   "
140819|NCT01724086|"~     The purpose of this study is to explore the efficacy and safety of TMC647055, TMC435, and~     low-dose ritonavir, administered together with and without ribavirin and of TMC647055,~     TMC435, low-dose ritonavir administered together with GSK233680k without ribavirin in a~     limited number of patients with chronic hepatitis C virus (HCV) infection.~   "
140844|NCT01723748|"~     The treatment with SA still leaves some questions unanswered. Firstly, SA treatment often~     results in a concomitant suppression of the insulin secretion, which might lead to clinically~     significant glucose intolerance. Secondly, the traditional evaluation of disease activity by~     measuring circulating levels of GH and total IGF-I is not reliable enough~      Hypotheses: Treatment of acromegaly with SA versus surgery alone is associated with:~        -  Glucose intolerance despite normalized insulin sensitivity~        -  Modified peripheral GH activity in peripheral target organs assessed on molecular~          endpoints~   "
140820|NCT01724073|"~     A food-to-food fortification strategy has been designed based on traditional foods of Burkina~     Faso to fight against micronutrient deficiencies in young children. Leafy vegetable sauces~     were formulated to improve their micronutrient contents and bioavailability. This efficacy~     study was designed to assess the effects of the regular consumption (one meal per day, 6 days~     per week) of these leafy-vegetable sauces enriched or not with liver on iron, zinc and~     vitamin A status, growth and morbidity of young children from poor urban districts of~     Ouagadougou. The study is conducted by IRD and IRSAT-DTA and will last 6 months. 432 12-15~     month-old children will be recruited and randomly assigned to one of the four following arms:~     three intervention groups, the two first receiving leafy vegetable sauce, the third one~     receiving one meal made of the fortified Misola gruel. In these three arms, blood samples~     will be collected at the beginning and at the end of the study. The fourth arm is an external~     control group and will not receive any food. In this fourth arm, blood samples will be~     collected only at the end of the study. Biochemical indicators of micronutrient status will~     be determined, and anthropometric data will be collected in all children. Morbidity will also~     be assessed in children of intervention groups.~   "
140821|NCT01724060|"~     Obesity and Type 2 Diabetes Mellitus are major health problems which are becoming a burden~     both for patients and health systems alike. The surgical and medical treatments available for~     these conditions have improved significantly in the last two decades. The investigators do~     not however know how these treatments compare to each other and how they act in the body to~     cause weight loss and diabetes improvements. The studies of this experiment are complementary~     to each other. They aim to answer related questions and will allow us to study how these~     treatments work and eventually develop safer and more effective therapies for obesity and~     diabetes.~   "
140822|NCT01724047|"~     The primary goal of this study is to identify efficacious and cost effective intervention~     strategies that can improve academic and psychological outcomes for children with ASD, and~     can be feasibly be implemented at fidelity by school personnel in under served elementary~     schools. Two simultaneous interventions will occur.~      In intervention 1, students with ASD in inclusion classrooms will be randomized to the~     Playground Intervention or a waitlist control group. In the Playground Intervention,~     UCLA/ROC/UPENN staff will work with school personals (teachers, paraprofessionals) to~     increase peer engagement on the yard.~      In intervention 2, students in special day classes will be randomized to the 'Schedule Tools~     Activities Transitions' Intervention (STAT) or wait-list control. In the STAT Intervention,~     UCLA/ROC/UPENN staff will work with teachers to implement behavioral strategies in the~     classrooms.~      In both interventions, the conditions are: 1) Immediate treatment, where the training will~     begin immediately after baseline measures are completed. 2) Wait-list treatment, where the~     training will begin the follow school year.~   "
140823|NCT01724034|"~     Daily lung ultrasound can help weaning from mechanical ventilation in difficult-to-wean adult~     patients. In this randomized trial, standardized lung ultrasound will be performed daily~     asssociated with standardized interventions aiming to decrease the total time in mechanical~     ventilation.~   "
140824|NCT01724021|"~     This multi-center, open-label, randomized study will evaluate the participant preference with~     subcutaneous versus intravenous administration of MabThera/Rituxan (rituximab) in~     participants with CD20+ diffuse large B-cell lymphoma or CD20+ follicular non-Hodgkin's~     lymphoma. In Arm A, participants will receive MabThera/Rituxan 375 mg/m2 intravenously (IV)~     on Day 1 of Cycle 1 and MabThera/Rituxan 1400 mg subcutaneously (SC) on Day 1 of Cycles 2-4,~     followed by MabThera/Rituxan IV in Cycles 5-8. Participants in Arm B will receive~     MabThera/Rituxan IV in Cycles 1-4 and SC in Cycles 5-8. All participants will receive 6-8~     cycles of standard chemotherapy (according to local country practice) with 8 cycles of~     MabThera/Rituxan. Anticipated time on study treatment is up to 24 weeks.~   "
140825|NCT01723995|"~     This study aims to evaluate the effect of low-level laser in pain relief and tissue repair in~     mothers with nipple trauma during breastfeeding, compared to a control group.~   "
140826|NCT01723982|"~     This trial investigates the effects of FE 200440 compared to placebo on implantation rate in~     women undergoing IVF/ICSI treatment~   "
140827|NCT01723969|"~     The EORTC GastroIntestinal Tract Cancer Group and the EORTC HeadQuarters wish to set up a~     European screening platform for advanced colo-rectal cancer (CRC) patients. The goal of this~     screening platform is to provide quick access to new drugs to patients by offering a new~     structure for clinical trials.~      Currently some of the most challenging clinical questions arise from the molecular~     sub-division of CRC that would theoretically allow to inhibit the specific, altered pathways~     in the patients.~      A major problem for trials in this personalized medicine is that the low frequency of the~     different mutations requires a high effort for screening and identifying the patients.~      The EORTC CRC screening platform will hopefully offer a feasible and efficient way to~     characterize the patients on the molecular basis of their tumors and allow to offer them~     rapid and preferential participation in clinical studies with new drugs targeted to their~     specific pathway alterations.~   "
140828|NCT01723956|"~     To compare the efficacy of cryotherapy and large loop excision of the transformation zone~     (LLETZ) procedures for the treatment of high-grade cervical intra-epithelial neoplasia~     (CIN2/3) among HIV-seropositive women by follow-up VIA, cytology and Human Papillomavirus.~      Hypothesis: LEEP will be more effective than cryotherapy in removing CIN 2/3 lesions in HIV~     positive women in South Africa~   "
140829|NCT01723943|"~     This randomized clinical trial studies educational counseling in improving communication and~     quality of life in spouses and breast cancer patients. An outpatient education and behavior~     skills training program may help spouses and patients with breast cancer communicate better~     and improve quality of life. It is not yet known whether educational counseling is more~     effective than an educational booklet in improving communication and quality of life.~   "
140830|NCT01723930|"~     Get a better understanding of the pathophysiological processes of acute respiratory failure~     following cardiopulmonary bypass to initiate timely therapies targeted on a cell line.~      Demonstrate that there is a relationship between increased transpulmonary gradients of~     inflammation biomarkers (sRAGE, sICAM-1, SPB, PAI-1, ROS) and pulmonary vascular resistance~     on the one hand and alveolo-capillary gas exchange on the other hand after cardiac surgery~     under cardiopulmonary bypass.~   "
140831|NCT01723917|"~     The purpose of this study is to evaluate the safety and efficacy of a soy based dietary~     supplement (phytoSERM) for hot flashes and age associated memory loss.~   "
140835|NCT01723865|"~     This is a clinical trial to evaluate the clinical benefit of remote monitoring in patients~     with heart failure having an ICD-CRT implanted.~      Study purpose The purpose of this study is to test the hypothesis that the monitoring of~     specific clinical parameters, obtained by remote controls of ICD-CRT could improve clinical~     course of patients with heart failure.~      Study design This is a prospective observational study, comparing clinical course of patients~     with heart failure having an ICD-CRT implanted, followed or not by remote monitoring. This~     study will include 870 subjects with ICD and CRT-D, and followed by a remote monitoring~     system (with or without weight and pressure external sensors) or followed by conventional~     ambulatory visits.~      Primary endpoints The primary endpoint of this study is to document no superiority of~     unplanned hospital access for cardiac reasons (included access to the emergency units ) or~     death for cardiovascular causes in remote monitoring group (with or without weight and~     pressure external sensors) compared to conventional follow-up (usual care group).~   "
140836|NCT01723852|"~     The study is a randomized, controlled, double blinded study evaluating the effect of~     recommended (400 IU) and 1 200 IU daily vitamin D substitution, given from 2 weeks to 2 years~     of age, on growth, bone development, neurologic and cognitive development, frequence of~     infectious diseases, allergic symptoms, and development of immunoregulation assessed at 2~     years of age.~   "
140837|NCT01723839|"~     In previously-untreated subjects with CLL, fludarabine and rituximab with or without~     cyclophosphamide (FR or FCR) produces complete responses (CR) of 40-80%. The major~     complication of FCR has been grade 3/4 neutropenia which was reduced using a lower dose of~     fludarabine and cyclophosphamide (FCR-Lite) The objective of this study is to evaluate the~     minimal residual disease (MRD) complete response rate (using the 2008 IWCLL guidelines) after~     4 cycles of FCR-Lite plus lenalidomide in subjects with previously untreated CLL.~     Lenalidomide is active in frontline treatment of CLL as well as in patients with refractory~     disease. MRD has been demonstrated to be a sensitive surrogate marker for progression-free~     survival. If patients are MRD negative complete responders (CR) they will stop at 4 cycles of~     FCR-Lite followed by the lenalidomide consolidation/maintenance arm of the study. If they~     have a MRD positive CR or partial response (PR) they will continue with 2 additional cycles~     of FCR-Lite plus lenalidomide followed by lenalidomide consolidation/maintenance. They will~     be re-tested for MRD after the 6th cycle of FCR-Lite and after 6 and 12 months of~     lenalidomide monotherapy If they have no response (NR) or progressive disease (PD) following~     4 cycles of FCR-Lite plus lenalidomide they will be removed from the study.~   "
140838|NCT01723826|"~     This Phase II, open-label extension (OLE), multicenter study will evaluate the long-term~     safety and tolerability of crenezumab in participants with mild to moderate Alzheimer's~     disease who have participated in and completed the treatment period of the Phase II Study~     ABE4869g (NCT01343966) or ABE4955g (NCT01397578). Participants who received placebo in Study~     ABE4869g (NCT01343966) or ABE4955g (NCT01397578) will receive crenezumab. Anticipated time on~     study treatment is 144 weeks.~   "
140839|NCT01723813|"~     The purpose of this study is to determine whether the intravenous and/or GM-CT-01~     administration can correct Tumor Infiltrating Lymphocytes (TIL) anergy and induce a more~     efficient and long-lasting anti-tumoral immune response following peptide vaccination.~   "
140840|NCT01723800|"~     This phase I trial studies the side effects and best dose of PI3K inhibitor BKM120 when given~     together with carboplatin and pemetrexed disodium in treating patients with stage IV~     non-small cell lung cancer. PI3K inhibitor BKM120 and pemetrexed disodium may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells,~     either by killing the cells or by stopping them from dividing. Giving PI3K inhibitor BKM120,~     carboplatin, and pemetrexed disodium together may kill more tumor cells~   "
140841|NCT01723787|"~     Infantile spasms (IIS), a characteristic epilepsy syndrome of infancy with often catastrophic~     developmental consequences, is known in some patients to have many different genetic,~     metabolic and structural etiologies. However, for most patients IIS is the only presenting~     clinical feature and the specific cause is unknown. Only two FDA approved pharmacologic~     treatments for IIS exist, Adrenocorticotropic hormone (ACTH) and vigabatrin. While vigabatrin~     may be the treatment of choice for Tuberous Sclerosis as a cause for IS, ACTH is the~     treatment of choice for all others. Unfortunately, a substantial number of patients may still~     not respond to ACTH and there is no a priori way that suggests which patients may be~     responders. This has led to the following key questions:~      Can novel genetic analyses determine known genetic causes of IS with greater efficiency (more~     timely and cost-effective)? Can novel genetic analyses determine previously unknown disease~     modifying genes that predispose individuals to develop IS? Can novel genetic analyses~     elaborate genes and gene polymorphisms that favor ACTH responsiveness? Do these polymorphisms~     suggest strategies to improve ACTH responsiveness?~   "
140842|NCT01723774|"~     A Phase II study to investigate the potential utility of PD 0332991 in the treatment of early~     stage ER+ Human epidermal growth factor receptor 2 (HER2)- breast cancer, to investigate~     whether the combination of PD 0332991 and anastrozole is able to: 1) improve the pathologic~     complete response rate when compared to the historical control of single agent aromatase~     inhibitors, 2) result in fewer patients with on therapy Ki67>10% compared to historical~     control.~   "
140843|NCT01723761|"~     It is a clinical, observational study to evaluate the correlations among arrhythmias,~     climatic variables and air pollution in patients with pacemaker and implantable defibrillator~     (ICD), followed by remote monitoring.~      Purpose of the Study: The purpose of this study is to test the hypothesis that changes in~     climatic variables, such as temperature, pressure and humidity, and changes of particulate~     matter <10µ (PM10), particulate matter <2.5µ (PM2.5), ozone (O3), carbon monoxide (CO),~     sulfur dioxide (SO2), nitrogen dioxide (NO2), are associated with an increase of~     supraventricular and ventricular arrhythmias.~      Objectives: The aim of this study is to determine whether changes in variables conditions~     affect the electrical stability of the myocardium in patients with pacemakers and ICDs.~      Population: male and female subjects, aged ≥ 18 years, implanted by a dual-chamber pacemaker,~     ICD or biventricular ICD (ICD-CRT). A total of 500 subjects from 15 cardiology centers of the~     Veneto region will be included.~   "
140860|NCT01723540|"~     Minilaparatomy cholecystectomy with ultrasonic dissection (UsD) is rarely considered and~     therefore we investigate here the contributions of UsD in early recovery.~   "
140845|NCT01723735|"~     Primary Objective:~      To assess the pharmacodynamic profile of alirocumab (SAR236553/REGN727) administered either~     alone or on top of ezetimibe or fenofibrate, based on low-density lipoprotein -cholesterol~     (LDL-C).~      Secondary Objectives:~        -  To assess the pharmacodynamic profile of alirocumab administered either alone or on top~          of ezetimibe or fenofibrate, based on other lipid parameters.~        -  To assess the pharmacokinetic profile of alirocumab administered either alone or on top~          of ezetimibe or fenofibrate.~   "
140846|NCT01723722|"~     This study compares treatment of Neonatal Abstinence Syndrome (NAS) with two different drugs~     for the difference in the length of treatment. This is a randomized, open-label comparison of~     phenobarbital and methadone versus phenobarbital and diluted deodorized tincture of opium~     (dDTO) where phenobarbital is the initial drug used to stabilize neonatal withdrawal.~   "
140847|NCT01723709|"~     The goal of this study is to enroll 1000 participants with a history of Multiple Sclerosis~     into the MURDOCK Study (Duke IRB Pro00011196) as well as into the Multiple Sclerosis Cohort~     study (Duke IRB Pro00023791). All 1000 participants will answer a 4-page questionnaire~     administered by a trained study coordinator which is designed to collect information on the~     participant's diagnosis of Multiple Sclerosis. The goal of the study is to seek genetic~     explanations for response to treatment, progression of the disease, and biomarker validation.~   "
140848|NCT01723696|"~     Vitamin C supplementation (500 mg per day) given to pregnant women who can not quit smoking~     will improve the pulmonary function tests in their offspring measured at 3 months of age.~   "
140849|NCT01723683|"~     There is a reducing incidence of pneumothorax, PIE and the combined outcome of death or BPD~     since the development of Surfactant therapy. A policy of intubation with surfactant~     administration and mechanical ventilation has become a standard therapy of infants at high~     risk of RDS. However, initial stabilization with CPAP and, if necessary, given rescue~     surfactant therapy has remained the standard therapy for preterm infants. Evidence reveals~     similar results with regard to mortality and neonatal morbidity between the above two~     strategies. The investigators intend to develop a method of minimally invasive surfactant~     therapy followed by early CPAP (MISTCPAP) in preterm Infants with high risk of RDS for~     improving the outcomes and reducing the incidence of BPD.~   "
140850|NCT01723670|"~     To evaluate the effects of multiple dose regimens of CHF 5074 administered once per day up to~     2 years on potential biomarkers of neurodegeneration in subjects with mild cognitive~     impairment.~   "
140851|NCT01723657|"~     The AML-03 regimen investigates the addition of G-CSF priming to both induction and~     consolidation chemotherapies administrated in the previous AML-99 trial (NCT01716793) refines~     risk-stratification based on biological characterization also the AML-03 trial incorporates~     novel approaches for hematopoietic stem cell transplantation: such as Mylotarg™ in vivo~     purging in autografts, extends unrelated volunteers donors for allotransplants in high-risk~     patients, and introduces reduced intensity conditioning in patients with elder age (more than~     50 years old).~      The aims of these modifications are to analyse eficacy and toxicity of this induction and~     consolidation therapy and to analyse the disease free survival in patients who achieved~     complete response following a risk adjusted therapy.~   "
140852|NCT01723644|"~     CLINPCT study is a prospective, randomized, controlled, open intervention clinical trial~     including adult patients admitted in the emergency department with community-acquired~     pneumonia. The objective of this clinical trial is to compare two strategies: clinical~     reassessment and procalcitonin guided diagnostic and therapeutic strategy in patients with~     community-acquired pneumonia. In the clinical reassessment arm, antibiotherapy is~     systematically started in the emergency department. The continuation, the discontinuation or~     the modification of the antibiotherapy initially prescribed in the ED were made at Day 1 and~     Day 5 based on clinical assessment. On Day 1, the aim of the clinical reassessment is~     diagnosis reassessment: to confirm or not the diagnosis of community-acquired pneumonia and~     to confirm or not the antibiotherapy. On Day 5, the aim of the clinical reassessment is to~     evaluate the possibility to stop the current antibiotherapy based on criteria for clinical~     stability defined by the Infectious Diseases Society of America (Temperature ≤37.8°C, Heart~     rate ≤100 beats/min, Respiratory rate ≤24 breaths/min, Systolic blood pressure ≥90 mm Hg,~     Arterial oxygen saturation ≥90% or pO2 ≥60 mm Hg on room air). In the procalcitonin arm,~     initiation and discontinuation of the antibiotherapy is based on the antibiotic stewardship~     based on procalcitonin (PCT) cut-off ranges previously published. Re-evaluation of the~     clinical status and measurement of serum PCT levels is mandatory after 6-24 h in all~     persistently sick and hospitalized patients in who antibiotic are withheld. The PCT algorithm~     can be overruled by pre-specified criteria, e.g. in patients with immediately~     life-threatening disease. If the algorithm is overruled and antibiotics are given, an early~     discontinuation of antibiotic therapy after 3, 5 or 7 days is more or less endorsed based on~     PCT levels. In hospitalized patients with ongoing antibiotic therapy PCT levels are~     reassessed on days 3, 5 and 7 and antibiotics will be discontinued using the PCT cut-offs~     defined above.~   "
140853|NCT01723631|"~     The objective of this project is to characterize the response TRAP positive patients with~     Multiple Sclerosis (MS) and to evaluate the sensitivity and specificity of the method in~     order to develop a second time as a diagnostic tool in this disease. We plan to analyze the~     response TRAP over a hundred patients with various clinical stages SEP (relapsing,~     progressive forms) and compared to healthy controls,~   "
140854|NCT01723618|"~     The purpose of the study is to determine the plasma levels of CRD007 in patients with~     abdominal aortic aneurysms after the administration of single doses of tablets containing 10,~     25 and 40 mg CRD007.~   "
140855|NCT01723605|"~     Two types of uterine repair described during cesarean section, the investigators will try to~     compare between the two techniques.~   "
140856|NCT01723592|"~     The aim of this study is the improvement of the vaginal flora by at least two grades of the~     Nugent scale after application of oral probiotics.~   "
140857|NCT01723579|"~     This study will investigate the efficacy and safety of the monophasic~      combined oral contraceptive (COC) containing 2.5 mg NOMAC and 1.5 mg E2 in~      healthy fertile Indian women.~   "
140858|NCT01723566|"~     Understanding the clinical practice of treatment of cardiac rhythm disorders all over the~     world and understanding the clinical outcomes of the treatment with its cardiac rhythm~     products in real world patient population is essential for Medtronic to be able to~     effectively develop new products and adjust existing products. In addition Medtronic is~     committed to monitor the safety of its products throughout the entire life cycle to ensure~     maximum product reliability.~      The Panorama 2 registry will enable Medtronic to increase data collection of clinical~     practice with Medtronic implantable Cardiac Rhythm and Disease Management (CRDM) devices in~     various regions across the world and on product reliability of its CRDM devices.~   "
140859|NCT01723553|"~     The study is designed to assess the demographic, clinical and imaging associations with the~     presence of microbleeds in atypical Alzheimer's disease. The primary hypothesis is that~     cognitive and functional performance will be poorer in atypical Alzheimer's subjects with~     microbleeds compared to those without microbleeds.~   "
140861|NCT01723527|"~     More Americans are arrested for drug offenses than for any other crime. In 2009, over 294,000~     arrests were made for possession of cocaine or heroin. Incarceration does not address the~     root problems and is frequently followed by relapse and re-arrest after release. In the case~     of opiate-dependent adults arrested for possession of heroin, one potentially effective~     alternative is to divert offenders to methadone maintenance treatment (MMT) as an alternative~     to adjudication of their case. MMT is an effective treatment for heroin dependence, and~     appears very effective for criminal offenders. However, cocaine use is common in MMT~     patients, including those with recent criminal justice involvement, and MMT alone is~     ineffective in addressing cocaine use. Continued cocaine use carries a substantial health~     burden and necessarily entails continued criminal activity. Thus, treatment for diverted~     opiate-dependent offenders should be designed to address cocaine use as well as opiate use. A~     Stage 1 Behavior Therapy Development project is planned over 2 years to adapt, manualize and~     pilot test the Therapeutic Workplace intervention for adults charged with heroin possession~     and offered diversion to methadone maintenance treatment as an alternative to adjudication of~     their case. The Therapeutic Workplace is a novel, employment-based contingency management~     intervention that has been very effective in promoting cocaine abstinence in adults who use~     cocaine persistently during methadone treatment. In the Therapeutic Workplace, participants~     are hired in a model workplace and required to provide drug-free urine samples to work and to~     earn maximum pay. Once we develop and manualize the adapted version of the Therapeutic~     Workplace for adults arrested for heroin possession, a pilot test will be conducted.~     Individuals identified by the State Attorney's office as candidates for diversion will be~     assessed for study eligibility. Given the high rates of injection drug use and~     injection-related transmission of HIV in Baltimore, this study will be restricted to~     injection drug users to evaluate the potential utility of this intervention in reducing HIV~     risk. Eligible individuals will be offered methadone maintenance in lieu of prosecution and~     will be required to remain in methadone treatment for 90 days. All participants will receive~     standard MMT, independent of whether they decide to participate in the pilot study. After~     beginning MMT, participants will be invited to enroll in the pilot study and randomly~     assigned to two study groups. Participants assigned to the Usual Care Diversion group will~     receive the standard MMT. Participants assigned to the Therapeutic Workplace Enhanced~     Diversion group will receive the standard MMT and the Therapeutic Workplace intervention. The~     data from this pilot study will serve as the foundation for a full-scaled randomized~     controlled trial. Overall, the Therapeutic Workplace could serve as a novel and ideal~     intervention for many heroin dependent adults involved in the criminal justice system. The~     use of MMT in lieu of adjudication in combination with the Therapeutic Workplace could~     increase drug abstinence and employment and decrease HIV risk and criminal activity in this~     refractory high-risk population.~   "
140862|NCT01723514|"~     The primary purpose of this study is to determine whether AMG 334 is safe and well tolerated~     in healthy subjects and migraine patients. As part of the secondary objectives, this study~     will be conducted to characterize the pharmacokinetic (PK) profile of AMG 334 after multiple~     SC doses in healthy subjects and migraine patients, as well as to characterize the effect of~     AMG 334 on the capsaicin induced increase in dermal blood flow after multiple SC doses in~     healthy subjects and migraine patients.~   "
140863|NCT01723501|"~     Purpose of this study is determine if skin application of chlorhexidine at birth would reduce~     infection in infants weighing <1500 g at birth.~   "
140864|NCT01723488|"~     [F-18]T808 is being developed as a diagnostic radiopharmaceutical for PET imaging of the~     human brain.~   "
140865|NCT01723475|"~     This is the first study where BAY2010112 is given to humans. Patients with castration~     resistant prostate cancer will be treated. Every patient will receive drug treatment, there~     is no placebo group. Patients will receive different dosages of BAY2010112 to determine the~     safety, tolerability and maximum tolerated dose (MTD) of BAY2010112.~      The study will also assess the pharmacokinetics and the clinical efficacy of BAY2010112.~      BAY2010112 will be given daily as subcutaneous injection or as continuous intravenous~     infusion. Treatment will be stopped if the tumor continues to grow, if side effects, which~     the patient cannot tolerate, occur or if the patient decides to exit treatment.~   "
140866|NCT01723462|"~     Clinical pharmacy has played a role in Emergency Departments (ED). The presence of~     pharmacists have been shown to reduce medication errors and improve the medication history~     taken at admission. In Denmark a recent study revealed that clinical pharmacists identified~     medication problems in 25% of all admission to the ED, of which 47 % were considered to be~     serious.~      However, the pharmacist recommendations are of little value if they are not acknowledged or~     followed by the physicians.~      The aim of the present study was to analyze how often and under which circumstances the~     physicians made use of pharmaceutical recommendations in an ED with a mixed patient~     population with special attention to those recommendations, which were of significant or~     disastrous importance.~   "
140867|NCT01723449|"~     In Demark acutely admitted patients are supposed to stay in the Emergency Department (ED) bed~     ward if the anticipated duration of stay is less than 48 hours.~      However, it is not a trivial matter to estimate duration of stay for emergency patients. a~     number of factors affect this, eg. social background, disease, hospital organisation.~      The aim of this study is to analyse whom are the best among the health staff to predict the~     length of stay: ED nurses, admitting doctors og the specialist, and to analyse if a number of~     variables can be used to improve the prediction.~   "
140868|NCT01723436|"~     Decision making capacity fatigues after repeated decisions similar to skeletal muscle. The~     result is decision fatigue, in which subsequent decisions are altered toward the status quo.~     Surrogates are at risk for decision fatigue yet it has not been studied. We propose a~     randomized study in the outpatient setting in surrogates and patients at high risk for~     needing to make complex decisions, in an effort to determine the impact of decision fatigue~     on surrogate self-control and subsequent choices.~   "
140869|NCT01723423|"~     The MROC Study seeks to evaluate and compare from the patient's point of view the leading~     options for breast reconstruction after mastectomy. This study will help patients,~     physicians, payers and policy makers better understand the various surgeries available for~     breast reconstruction. Although many women choose reconstruction, the number of options as~     well as their pros and cons can make decision making difficult and stressful. From this~     research, we hope to learn more about what works best for patients undergoing these~     operations.~   "
140870|NCT01723410|"~     UCLA researchers looking for healthy individuals (aged 35-50) who have a home computer with~     internet access, are not pregnant, planning to become pregnant, or currently breastfeeding~     (if female), to participate in a study investigating whether real-world experiences alter the~     brain and body. This study takes place over an eight week period and involves providing the~     names of 8 close friends or family members, completing a neuroimaging session, providing~     blood and saliva (for genetic analysis), and a 6-week period in which participants login~     twice a week to complete online questionnaires. Compensation is up to $210 for those who~     complete all aspects of the study. Please email realworld.ucla@gmail.com for more~     information.~   "
140871|NCT01723397|"~     The objectives of this protocol are:~        1. to confirm the inhibitory effect of Nasaleze on the immediate response to nasal~          challenge with antigen, and~        2. to show that inhibition of the immediate response to nasal challenge with antigen by~          Nasaleze inhibits subsequent inflammatory events.~   "
140879|NCT01723293|"~     The purpose of this study was to examine the behavior of the fetal heart rate in response to~     different intensities of acute maternal exercise in training and non-training pregnant women~   "
140872|NCT01723384|"~     Naltrexone, a µ-opioid receptor antagonist, is a promising agent for methamphetamine-using~     and binge-drinking men who have sex with men (MSM). Naltrexone has shown efficacy in reducing~     relapse to amphetamines and is FDA-approved for alcohol dependence. Oral naltrexone is~     inexpensive and has few toxicities but the standard daily regimen for naltrexone is~     problematic as patients forget to take the medication. Given the challenges in daily dosing,~     alternate regimen schedules have been proposed to increase efficacy and expand the population~     that may benefit from this pharmacologic agent. One approach is intermittent targeted~     administration of naltrexone, whereby individuals take the medication as-needed in~     anticipation of substance use or during periods of craving. Administration of naltrexone~     prior to exposure to amphetamines significantly attenuates craving and targeted naltrexone~     has shown efficacy in reducing heavy alcohol use. However, there have been no studies~     assessing intermittent targeted dosing of naltrexone among methamphetamine-using and~     binge-drinking MSM. Polysubstance use patterns are common among MSM, and studies among those~     who abuse more than one substance are urgently needed. The aims of this study are to~     determine whether targeted dosing of naltrexone is feasible, tolerable and acceptable among~     non-dependent methamphetamine-using and binge-drinking MSM.~   "
140873|NCT01723371|"~     This study will determine the safety and feasibility of using a β-blocker (in this case~     carvedilol) in the treatment of pediatric patients with Left Heart Failure (LHF) in children~     with Pulmonary Arterial Hypertension (PAH). Carvedilol affects the nervous system, the same~     system that is highly activated in response to stress in patients with PAH. Each patient is~     administered a dosage of carvedilol, according to their weight. This dosage is increased~     incrementally over the span of the study, if the patient responds well to the drug. The study~     will determine whether the potential adverse side effects of carvedilol outweigh the possible~     positive results in reducing LHF. The hypothesis of this study predicts that carvedilol will~     have positive effects in treating LHF, similar to their use in treatment of Right Heart~     Failure (RHF). This is a single-centered pilot study. Each patient will be studied for~     approximately 31 weeks.~   "
140874|NCT01723358|"~     The goal of this study is to obtain data that well help inform the feasibility and design of~     a randomized control trial of the therapeutic Neuromuscular Electrical Stimulation (NMES)~     technique in improving the swallowing function of young infants presenting with severe~     dysphagia.~   "
140875|NCT01723345|"~     Percutaneous coronary intervention (PCI) has become the most common form of coronary~     revascularization worldwide. Although PCI is a safe procedure, it may have multiple risks~     including bleeding, coronary dissection, abrupt vessel closure, and myocardial necrosis. It~     is estimated that approximately 25% of patients undergoing PCI have significant~     postprocedural creatinine kinase (CK)/creatinine kinase myocardial band (CK-MB) elevations~     and approximately 50% of patients have significant post-procedural troponin elevations.~     Initially, it was felt these elevations were simple enzyme leaks with no long-term~     implications.~      Now, several studies have demonstrated that periprocedural infarction is associated with~     short-, intermediate-, and long-term adverse outcomes, most notably mortality. Pretreatment~     with antiplatelets such as aspirin and clopidogrel play an important role in reducing~     cardiovascular events (CV events) following PCI.~      Omega -3 polyunsaturated fatty acids (PUFAs) have antiplatelet effect. It may also improve~     response to aspirin and clopidogrel in low-response patients.~      This study is a randomized clinical trial (RCT) evaluating the effect of omega 3 supplement~     [with 400mg Eicosapentaenoic acid (EPA) and 200mg docosahexanoic acid (DHA)] on short-term~     (within 30 days) and long-term (after one year) major adverse cardiac events (MACE) in~     patients undergoing elective PCI. Eighty patients planed to do elective PCI will be~     categorized into two groups. The first group will be received standard regimen for PCI~     (aspirin, clopidogrel, and heparin) and the second group will be treated with standard~     regimen in addition to 3 gram omega 3 (12 hours before PCI). The main end point of the trial~     was short-term (within 30-days) and long-term (after one year) incidence of MACE (death,~     myocardial infarction, or unplanned revascularization).~   "
140876|NCT01723332|"~     Transition is the planned movement of teens with chronic conditions from child-centered to~     adult-oriented healthcare. National bodies have published detailed guidelines about the~     importance of helping teens move to adult healthcare. However, there is no research regarding~     how to best organize and deliver Congenital Heart Disease (CHD) transition programs. Data is~     urgently needed. Therefore, the aim of this program is to develop research evidence that will~     better prepare health care providers to improve how they can help adolescents with~     transition.~      This project will determine whether a nurse-led transition intervention program is better at~     preparing teens with CHD to independently manage their medical care, compared to the care~     that is currently provided. The most important finding of this study will be whether or not~     these teens subsequently attend the adult cardiology clinic that specializes in CHD problems,~     and the timing of when they attend.~      Hypothesis: A transition intervention in combination with usual care, improved time to first~     Adult Congenital Heart Disease (ACHD) clinic attendance compared to usual care alone.~   "
140877|NCT01723319|"~     Objectives:The purpose of the study is to explore the efficacy and safety of HBLPADD Coil~     deep brain TMS in subjects with ADHD.~      Patient Population: The intention is to treat 40 patients diagnosed with ADHD. The patients~     will be of all racial, ethnic and gender categories, ranging from 18 to 65 years of age.~      Structure: The study is a randomized, prospective, 5 weeks, double blind study. Blinding: The~     treatment administrator and the study personnel and patients will be masked to the treatment~     being administrated.~      The study group will receive active dTMS treatment and the control group will receive an~     inactive, sham treatment~   "
140878|NCT01723306|"~     T cells can penetrate virtually every biologic space and have the power to dispose of normal~     or malignant cells as seen in viral and autoimmune diseases and in the rare spontaneous~     remis-sions of cancer. However, T cells are easily tolerized to self or tumor antigens and~     immune surveillance has manifestly failed in every cancer that is clinically apparent. It~     is the goal of these studies to supply the specificities and affinities to patient T cells~     without regard for their endogenous T cell receptor repertoire, directed by~     antibody-defined recognition to kill malignant cells based on their expression of antigen. We~     will achieve this by preparing chimeric IgCD28TCR genes in mammalian expression vectors to~     yield designer T cells from normal patient cells. This extends the approach of Anderson,~     Rosenberg and co-workers to introduce or augment expression of genes in patients' T cells in~     a therapeutic setting.~      Prior studies in model systems demonstrated that recombinant IgCD28TCR could direct modified~     T cells to respond to antigen targets with IL2 secretion, cellular proliferation, and~     cytotoxicity, the hallmarks of an effective, self-sustaining immune response. It therefore~     becomes of paramount interest to extend these studies to a human system of widespread~     clinical relevance to explore the clinical potential of this new technology. The target~     antigen for these studies is carcinoembryonic antigen (CEA) which is predominantly expressed~     on tumors of the colon and rectum, breast, pancreas and other sites.~   "
140880|NCT01723280|"~     Aim: to investigate the effect of a high inspiratory oxygen fraction (FiO2) given during and~     after laparotomy procedures on occurrence of a subsequent, new or recurrent, cancer diagnosis~     at a long-term follow-up.~      Background: A high inspiratory oxygen fraction (FiO2 = 0.80) has been linked to prevention of~     surgical site infection, but the Danish randomized clinical multicenter trial, the PROXI~     trial, found no difference in frequency of surgical site infection. In fact, long-term~     mortality was significantly increased with a hazards ratio of 1.30 in patients receiving 80%~     oxygen, and this appeared to be statistically significant in patients undergoing cancer~     surgery, but not in non-cancer patients.~      At this point, no convincing mechanism explains the observed increased mortality after~     hyperoxia, as the long-term pathophysiological effects of oxygen are not fully understood.~      Primary hypothesis of this follow-up study of the PROXI trial: Use of 80% oxygen increase the~     frequency of patients with a subsequent, new or recurrent, cancer.~   "
140881|NCT01723267|"~     Accurate assessment of the size of follicles is important in IVF treatment.Timing of oocyte~     maturation and subsequent egg collection is largely based on follicle size. An accurate~     assessment of follicle size and appropriate timing of HCG result in retrieval of more mature~     oocytes, improved fertilization and higher pregnancy rates. in 3D technology- fter the~     capturing of a 3D image of an ovary, SonoAVC automatically analyzes the volume dataset,~     identifies the boundaries of hypoechoic follicles, and provides estimates of their absolute~     dimensions. These measurements include the largest diameters in three orthogonal planes, the~     mean follicular diameter (MFD), the volume of the follicle, and the volume-based diameter~     (d(V)) of the follicle. In the current study the investigators aim to evaluate the use of~     this automated technique of follicle measurement vs. standard 2D technology on the timing of~     oocyte maturation and subsequent oocyte retrieval. The investigators speculate that 3D~     assessment will increase the rate of mature oocyte collection, and eventually will improve~     other treatment outcomes such as fertilization rate.~   "
140882|NCT01723254|"~     The purpose of this study is to assess the safety and tolerability of different doses of~     PF-06444753 and PF-06444752 in subjects with allergic rhinitis.~   "
140883|NCT01723241|"~     This is a study to assess the safety, tolerability, and pharmacokinetics of XAF5 Gel when~     applied to the skin of healthy volunteers.~   "
140884|NCT01723228|"~     This is a 24-week, multicenter, randomized, double-blind, placebo-controlled, add-on,~     parallel-group study to evaluate the effect of rasagiline on cognitive function in adults~     with mild cognitive impairment (MCI) in Parkinson's disease (PD-MCI).~   "
140885|NCT01723215|"~     Military deployment to combat zones involves exposure to trauma at a higher than average rate~     and therefore presents a unique opportunity to study predisposing factors to posttraumatic~     stress reactions and test strategies designed to prevent and ameliorate posttraumatic~     symptoms. Decades of scientific research on the origins of resilience and vulnerability to~     combat-related posttraumatic stress symptoms revealed various predisposing and protective~     factors. All these factors however, offer limited opportunity for systematic pre-deployment~     prevention efforts. Considering the magnitude of psychological adjustment difficulties~     encountered by combat personnel in deployment and the limited access to existing~     evidence-based therapies for PTSD, the development and testing of a novel evidence-based and~     theory-driven prevention protocol for these problems is of considerable significance. The~     current study translates cognitive-neuroscience knowledge and attention bias modification~     research into a novel computerized training tool that could be easily delivered to soldiers~     during different stages of the deployment cycle. If proved efficacious in reducing risk for~     posttraumatic symptoms ABMT could be integrated into the Army's resilience training program.~     Thus, we propose a longitudinal double-blind randomized controlled study of ABMT in soldiers.~     We will assess attention bias and symptoms before deployment, will randomly assign soldiers~     to either 8 ABMT sessions, 4 ABMT sessions, 8 Placebo training sessions, or no training.~     Following 6 months of deployment to combat zone symptoms will be assessed again.~   "
140886|NCT01723202|"~     This randomized phase II trial studies how well dabrafenib works with or without trametinib~     in treating patients with recurrent thyroid cancer. Dabrafenib and trametinib may stop the~     growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet~     known whether dabrafenib is more effective when given with or without trametinib in treating~     thyroid cancer~   "
140887|NCT01723189|"~     40% of patients with Sleep Disorder Breathing (SDB) appearing during the acute phase of~     stroke show a respiratory pattern characterized by central apnoeas and/or periodic breathing.~      Clinical studies conducted in patients with hearth failure and central apnoeas have~     demonstrated the pathogenetic central role of hypersensitivity of central and peripheral~     chemoreceptors in association with baroreflex hypersensitivity, expression of hyperactivity~     of sympathetic nervous system.~      The joint study of chemoreflexes and baroreflexes in patients with central apneas during the~     acute and subacute phase of ischemic stroke represents, to our knowledge, a novelty in~     literature, that should supply useful elements to clarify the pathogenesis and the clinical~     and prognostic significance of these disorders.~      Investigators expect a difference in the analysis of the baroreflexes and chemoreflexes in~     patients with ischemic stroke/transient ischemic attack (TIA) and central apnoeas than~     patients with ischemic stroke not accompanied by respiratory problems and compared with~     healthy controls.~   "
140888|NCT01723176|"~     Hypothesis: Goal-directed echocardiography by trained critical care physicians is equivalent~     to that of echocardiography technicians/cardiologists for the purpose of determining etiology~     (reason) of cardiopulmonary failure.~   "
140889|NCT01723163|"~     The primary goal of the current study is to evaluate the effectiveness of a combined~     tele-health and contingency management (CM) intervention that investigators are calling~     Abstinence Reinforcement Therapy (ART). Proposed is a comparative effectiveness trial with a~     two-group design in which 300 Veteran smokers will be randomized to either:~      ABSTINENCE REINFORCEMENT THERAPY (ART) a proactive tele-health intervention that combines~     guideline based cognitive-behavioral telephone counseling (TC), a tele-medicine clinic for~     access to nicotine replacement (NRT), and intensive behavioral therapy through mobile~     contingency management.~      TELE-HEALTH FOR SMOKING CESSATION a proactive tele-health intervention that will provide~     controls for therapist, medication, time and attention effects. The tele-health intervention~     provides the same guideline based cognitive-behavioral smoking cessation telephone counseling~     (TC), and tele-medicine clinic for access to NRT as in the ART intervention.~   "
140890|NCT01723150|"~     Background: Klebsiella pneumoniae liver abscess is the most common etiology of liver abscess~     in Singapore and much of Asia, and its incidence is increasing. Current management includes~     prolonged intravenous antibiotic therapy, but there is limited evidence to guide oral~     conversion. The implicated K1/K2 capsule strain of Klebsiella pneumoniae is almost~     universally susceptible to ciprofloxacin, an antibiotic with high oral bioavailability. Our~     primary aim is to compare the efficacy of early (<1 week) step-down to oral antibiotics, to~     continuing 4 weeks of intravenous antibiotics, in patients with Klebsiella liver abscess.~      Methods/Design: The study is designed as a multi-centre randomised open-label active~     comparator-controlled non-inferiority trial, with a non-inferiority margin of 12%. Eligible~     participants will be inpatients over the age of 21 with a CT or ultrasound scan suggestive of~     a liver abscess, and Klebsiella pneumoniae isolated from abscess fluid or blood.~     Randomisation into intervention or active control arms will be performed with a 1:1~     allocation ratio. Participants randomised to the active control arm will receive IV~     ceftriaxone 2 grams daily to complete a total of 4 weeks of IV antibiotics. Participants~     randomised to the intervention arm will be immediately converted to oral ciprofloxacin 750mg~     twice daily. At week 4, all participants will have abdominal imaging and be assessed for~     clinical response (CRP <20 mg/l, absence of fever, plus scan showing that the maximal~     diameter of the abscess has reduced). If criteria are met, antibiotics are stopped; if not,~     oral antibiotics are continued, with reassessment for clinical response fortnightly. If~     criteria for clinical response are met by week 12, the primary endpoint of clinical cure is~     met. A cost analysis will be performed to assess the cost saving of early conversion to oral~     antibiotics, and a quality-of-life analysis will be performed to assess if treatment with~     oral antibiotics is less burdensome than prolonged IV antibiotics.~      Discussion: Our results would help inform local and international practice guidelines~     regarding the optimal antibiotic management of Klebsiella liver abscess. A finding of~     non-inferiority may translate to the wider adoption of a more cost-effective strategy that~     reduces hospital length of stay and improves patient-centered outcomes and satisfaction.~   "
140891|NCT01723137|"~     Patient reported pain, stress, and anxiety measures have been found to be inter-related, but~     it is not known if they are all associated with receiving opiate medications. The objective~     of this study is to determine if patients' degree of reported pain, stress, or anxiety is~     associated with receiving opiate pain medications in the emergency department or at~     discharge. Alert patients at least 18 years of age and who report pain greater than 3/10 are~     eligible to participate in the study. Consenting patients complete Visual Analog Scales~     describing their perceived pain, stress, and anxiety from enrollment until discharge.~     Demographic data and administration of pain medication is also recorded. Visual Analog Scale~     scores among patients who received an opioid pain medicine in the emergency department and at~     discharge will be compared to those who did not.~   "
140892|NCT01723124|"~     The purpose of this research is to evaluate whether repeating a screening Molecular Breast~     Imaging (MBI) study two years after an initial screening MBI study further improves breast~     cancer detection in women with dense breast tissue.~   "
140893|NCT01723111|"~     -  Dialysis modality may influence the oxidative stress and proinflammatory cytokines in~          ESRD patients.~        -  Dialysis modality may affect hepcidin~        -  Dialysis modality may influence iron and ESA requirements.~   "
140894|NCT01723098|"~     The main aim of this study was to analysed the security of a supervised exercise program on~     maternal cardiovascular system and assess the positive effects of this program on maternal~     cardiovascular function and structure~   "
140895|NCT01723085|"~     Anti-Mullerian hormone (AMH) is a marker for ovarian reserve. It is well known that ovarian~     surgery for endometriosis lowers Anti-Mullerian hormone, but little is known for other~     surgeries. We seek to investigate the hormone variations before and after an open myomectomy.~      Hypothesis: Anti-Mullerian hormone levels drop following surgery but return to normal levels~     in a few months~   "
140896|NCT01723072|"~     This study will assess the impact of omalizumab on the quality of life improvement when added~     to the standard therapy in refractory patients suffering from chronic spontaneous urticaria~     and angioedema.~   "
140897|NCT01723059|"~     Traditionally, H pylori infection has been treated with conventional triple therapy. This~     includes amoxicillin, clarithromycin and a proton pump inhibitor all given daily for 10-14~     days. In Europe, the guidelines now advocate treatment of H pylori with sequential therapy~     which is 5 days of amoxicillin therapy with proton pump inhibitor followed by 5 days of~     clarithromycin, metronidazole, and proton pump inhibitor with better response rates. We~     hypothesize that H. pylori resistance pattern and treatment response rates observed in Europe~     will not be predictive of resistance patterns and response rates in the United States.~   "
140898|NCT01723046|"~     The purpose of this pilot study is to investigate the clinical effects of a new upper limb~     robot assisted therapy device that is linked to a virtual therapy environment in patients~     with stroke.~   "
140899|NCT01723033|"~     Comparison of the neurophysiological response of OCD and PTSD patients (both considered~     anxiety syndromes) in error processing. The patients will perform three computerized tasks~     while a net of electrodes (for EEG measurement) will be placed on their head. This data will~     then be compared to a previously collected healthy control sample.~   "
140900|NCT01723020|"~     First in human, open-label, sequential dose escalation and expansion study of AMG 232 in~     subjects with advanced solid tumors or multiple myeloma~   "
140901|NCT01723007|"~     The study was designed to answer the primary question: the consumption of one apple three~     times daily between meals reduces serum levels of cholesterol above 240 mg/dL in overweight~     women? The second and important hypothesis was designed for evaluate the reduction in body~     weight by intakes of fruits. Therefore, the increased consumption of apples could displace~     the consumption of other foods and promoting satiety and input significant reduction in body~     weight compared to other fruit (Pear) of similar nutritional composition or food (cookies)~     made from oats with fiber and total calories similar to those observed in these fruits. To~     demonstrate the effectiveness of these supplements we used a clinical trial with three arms~     (apple, pear and oatmeal cookies).~   "
140913|NCT01722851|"~     To identify a panel of circulating miRNA markers which could help identify those breast~     cancer patients who are most likely to respond well to neoadjuvant and adjuvant chemotherapy,~     and indeed serve as an overall prognostic factor and stratify patients into risk categories~     which would further guide their management. Similarly, the investigators aim to identify a~     panel of circulating miRNA markers which could monitor patient's response to chemotherapy and~     hormonal therapies. Ideally a suitable panel of markers would show significant changes in~     expression level in good-responders whilst little or no change would be observed in miRNA~     expression in non-responders.~   "
140914|NCT01722838|"~     B-ME is a research intervention study designed to address the needs of African American men~     who have sex with men (AAMSM) who are at high risk for HIV. The intent of the intervention is~     to decrease HIV risk behaviors among African American MSM using an intervention developed by~     and for African American MSM.~      The hypothesis guiding this study is: that participants who complete B-ME intervention will~     report greater reductions in sexual risk behaviors than the standard of care comparison~     group.~   "
140902|NCT01722994|"~     Some Dermatologists prefer absorbable suture to non-absorbable suture in the closure of punch~     biopsy sites. The reason these are often preferred is because patients do not have to pay for~     another visit to get the suture material removed. Also patients are not inconvenienced into~     returning to the office for suture removal1. However, the absorbable suture material~     currently used by most Dermatologists is very expensive.~      In order to evaluate ways to reduce costs for patients, we will compare a less expensive~     suture material (chromic gut) with one of the absorbable suture materials currently used in~     clinical practice (PDS).~      Patients who are eligible and choose to participate in the study will undergo a punch biopsy~     and a suture will be used to close the skin. The type of suture received by the patient will~     be randomized, like the flip of a coin. Group A will receive PDS and Group B will receive~     chromic gut suture.~      After one weeks time, the patient will return to clinic and their dermatologist will evaluate~     the biopsy site for redness, wound infection, wound opening, and scar formation. The patients~     will be given a questionnaire evaluating their satisfaction with the cosmetic outcome and any~     pain caused by the suture materials. If the suture came out before the visit, the patient~     will be asked to report on what day the suture fell out. The patients will return two more~     times over the next two weeks to receive the same questionnaire and evaluation by their~     dermatologist.~   "
140903|NCT01722981|"~     Percutaneous tracheostomy is routinely performed in most intensive care units in the~     world.Several studies have shown that the procedure is safe and economically efficient in~     comparison to open surgical operation in the operating room.~      In our institution as in a number of institutions in the country, it is acceptable to perform~     the operation by placing the tube on a high position near the vocal cords by direct~     laryngoscopy and then puncturing the trachea with a needle, by location of the anatomy by~     palpation of the neck.~      Using technological aids, such as direct sonography and bronchoscopy in real time may~     significantly reduce the rate of complications as a result of performing percutaneous~     tracheostomy.~      So far, no systematic comparison has been made among the three methods.~   "
140904|NCT01722968|"~     To explore molecular biomarkers and/or gene expression signatures that predict response to~     bevacizumab given in combination with paclitaxel as first line therapy in HER2 negative~     metastatic breast cancer (MBC).~   "
140905|NCT01722955|"~     The aim of the study is to compare effect of pre-warmed intravenous fluids on the early~     outcomes in ambulatory patients undergoing monitored anesthesia care.~   "
140906|NCT01722942|"~     The primary objective is to compare the efficacy of the treatment using implantable~     cardioverter defibrillator (ICD) implantation to that of the treatment using amiodarone in~     the primary prevention of all-cause mortality in high-risk patients with Chagas~     cardiomyopathy and non-sustained ventricular tachycardia (NSVT).~   "
140907|NCT01722929|"~     The aim of this study is to assess the role of skin sensors in obtaining reliable and~     accurate serial measurements of skin parameters in the context of cutaneous skin wound~     healing.~   "
140908|NCT01722916|"~     The purpose of this study is to find how much hyaluronidase should be used when receiving~     injections of fillers.~   "
140909|NCT01722903|"~     Colorectal cancer (CRC) is the second leading cause of cancer deaths in the United States.~     About 90% of CRC related deaths are due to metastatic spread—mostly to the liver and lungs.~     With adequate multidisciplinary patient selection, CRC liver and lung metastasectomy~     significantly improves survival and offers the best chance for a cure. However, patients with~     limited lung or liver metastases are clinically underserved and poorly scientifically~     studied. The individual indication for resection and the decision making for adjuvant~     systemic therapies remains a challenge. More sensitive techniques to detect occult disease~     are needed for metastatic CRC (mCRC) patients, and perioperative analysis of circulating~     tumor cells (CTCs) may provide an outstanding opportunity to develop such innovative methods.~     We hypothesize that CTCs are enriched during CRC liver and/or lung metastasectomy, and that~     they can be isolated and characterized in an attempt to identify novel therapeutic targets.~      CTCs are believed to be causing metastasis and may provide a non-invasive alternative to~     organ biopsies for the detection, characterization and monitoring of solid cancers. CTC~     numbers have been shown to be a strong predictor of Progression Free Survival and Overall~     Survival for mCRC patients. The CellSearch system (Veridex LLC, Ratinas, NJ, USA) currently~     is the only FDA approved test for the evaluation of CTC numbers in metastatic breast,~     prostate and colorectal cancer. However, the rarity of CTCs in the blood leads to limited~     capture efficiency and the CellSearch system fixes cells, preventing further molecular~     characterization of CTCs by functional assays and primary cell culture. In this protocol the~     CellSearch system will be compared to a new technology, called the Flexible Micro Spring~     Array (FMSA) device, developed by Dr. Zheng, Department of Bioengineering, Penn State~     University, University Park. This novel approach enables size-exclusion based filtration for~     viable CTC enrichment. The FMSA device is inexpensive, works rapidly, and retains viable CTCs~     for further biological study. Using both the CellSearch system and the FMSA device, we will~     determine the kinetics of CTC shedding into circulation, develop an effective system for~     isolation, enumeration, and further enrichment CTCs, and use this system to find~     characteristics of different CTC populations.~   "
140910|NCT01722890|"~     Primary Objective:~      The primary aim of the study is:~      1.To identify and validate a panel of molecular and cytogenetic biomarkers able to predict~     Durable Complete Response (DCR) after chemotherapy and trastuzumab in patients with~     HER2-positive locally advanced or metastatic breast cancer.~      Secondary Objective:~      The secondary aims of the study are:~        1. To perform a comprehensive exploration of the molecular and cytogenetic characteristics~          of DCR patients to identify any possible correlation between the tumour's biological and~          cytogenetic characteristics and the degree of clinical response to trastuzumab;~        2. To produce data in preparation for further translational studies on HER2-positive breast~          cancer.~   "
140911|NCT01722877|"~     Several studies have shown that stenting of the femoropopliteal artery in the lower leg leads~     to improved overall results compared to balloon angioplasty alone. However, scar tissue~     development can occur within the stent, a process called restenosis. Treatment of these~     in-stent restenotic lesions has a high procedural success rate but recurrence of scar tissue~     is frequently seen. Several methods have been proposed to treat in-stent restenosis in the~     lower leg arteries but mixed results have been noted. In this study we hypothesize that~     simultaneous tissue excision and aspiration using the JetStream Navitus device (Medrad) can~     lead to a high rate of acute procedural success with low intraprocedural complications and an~     acceptable recurrence rate of restenosis at 6-month follow-up.~   "
140912|NCT01722864|"~     A study to show the safety of COV155 in patients with osteoarthritis of the knee or hip or~     moderate to severe chronic low back pain.~   "
140915|NCT01722825|"~     The main purpose of this study is to evaluate the safety and side effects of LY2157299 in~     Japanese participants with advanced cancer or cancer that has spread to other parts of the~     body.~   "
140916|NCT01722812|"~     The purpose of this exploratory study is to investigate the clinical efficacy of cromoglicate~     cream compared to cream vehicle in the treatment of itch in psoriasis~   "
140917|NCT01722799|"~     Significant lesions in small coronary arteries are frequently found (35%-50%) in patients~     with coronary artery disease. Independently of the type of coronary angioplasty the~     restenosis and the need for repeat revascularization remains the main limitation,~     representing a challenging problem even in the DES (drug eluting stent) era. Recently has~     been developed drug eluting balloons (DEBs), which have been successfully tested in small~     series on in-stent restenosis, but few evidence is available in the context of small vessels~     disease.~      The current study has been designed to know, in one hand, the clinical efficacy of the Drug~     elluting balloon IN.PACT FALCON and, in other hand, the effectiveness, and the~     cost-effectiveness incremental analysis of DEBs (IN.PACT FALCON vs. DES ( RESOLUTE INTEGRITY)~     in patients with de novo lesions in small vessels.~   "
140918|NCT01722786|"~     Patients treated with Vitamin K antagonists (VKA) or direct oral anticoagulants as~     Rivaroxaban, Apixaban, Edoxaban or Dabigatran, who experience severe bleeding and/or need~     urgent interventions/operations that cannot wait are included in this registry, or during~     emergency operations.~   "
140919|NCT01722773|"~     The use of domiciliary non-invasive positive pressure ventilation (NPPV) in stable chronic~     obstructive pulmonary disease (COPD) with chronic hypercapnic respiratory failure has yielded~     variable effects on survival, quality of life and dyspnea. The investigators hypothesized~     that use of NPPV in stable COPD might result in improvement in quality of life and dyspnea.~   "
140920|NCT01722760|"~     Children born prematurely are of greater risk of developing chronic lung disease~     (Bronchopulmonary Dysplasia).~      With an increase in the amount of premature children, we expect an increasing number of~     children with BPD.~      Today we do not have many ways of predicting or treating this condition, and the children are~     usually in hospital for several months after birth. Many are dismissed with home oxygen.~     Children with BPD are typically often re-submitted to hospital with respiratory disease the~     first couple of years, and some of them have problems throughout childhood and into~     adulthood.~      Other scientists have found a correlation between BPD and Chronic Obstructive Pulmonary~     Disease (COPD).~      The condition as well as the treatment (steroids), are associated with great risk of adverse~     effects as Cerebral Palsy, blindness, deafness and mental retardation.~      The investigators wish to find a safe way to identify the children in greater risk of~     developing BPD, who could therefore benefit from a more intensive treatment.An early~     diagnosis would increase the possibility of predicting the prognosis.~      Other studies have proven a connection between both low vitamin A and D and high exhaled~     nitrogen oxide (NO) with lung disease.~      With this trial the investigators wish to make a reference material for NO and vitamins A and~     D in infants admitted to the neonatal department at two hospitals in Denmark, both with and~     without treatment with nasal Continuous Positive Airway Pressure.~      The investigators furthermore wish to describe an eventual connection between BPD and these~     factors by examining a large group of children on 7 specific occasions within the first two~     months of life and at a one year follow up.~   "
140921|NCT01722747|"~     BRIEF SUMMARY: This study, which is closed to enrollment, is testing the efficacy of a~     tobacco-control intervention geared towards school teachers in Bihar, India. This cluster~     randomized trial aims to promote tobacco use cessation among teachers and increase tobacco~     policy adoption in 72 Bihar schools. Teachers are the focus of the study because as role~     models for youth and key opinion leaders related to community norms, they represent an~     important group for tobacco control. Teachers in Bihar also have reported high rates of~     tobacco use. According to the Global School Personnel Survey conducted in 2006, 39% of~     teachers in the eastern region of India (which includes Bihar) use some form of tobacco,~     compared to the national average of 29%. This study aims to reduce these numbers through~     discussion groups with teachers, individual cessation counseling, educational materials, and~     a tobacco policy workgroup in each intervention school. This study is a collaboration between~     US researchers and researchers at the Healis-Sekhsaria Institute for Public Health, Mumbai~     India.~   "
140922|NCT01722734|"~     A randomized controlled trial was conducted to assess the effectiveness of text reminders~     sent to ACT users through an automated text messaging system short-message-system.~      Study hypothesis: text message reminders increase adherence~   "
140923|NCT01722721|"~     physicians in the Emergency Department spend their time on interviewing and examining~     patients, file documentation, communication with colleagues about the patients.~      Introduction of IT technology aims to reduce the administrative workload. However it is the~     impression that more and more time are used behind the PC rather than at the side of the~     patient.~      The aim of this study is to describe how the time is distributed between different task for~     an ED physician, and to analyse whether there are differences in time distribution if the~     physician is working in the outpatient area versus admission area of the ED.~   "
140924|NCT01722708|"~     Abnormal vaginal flora is a risk factor for preterm labor. Therefore, in high risk~     pregnancies for preterm labor the diagnosis and treatment of abnormal flora is indicated.~     Clindamycin and metronidazole given orally are both acceptable treatments in these cases. The~     purpose of this study is to compare the effectiveness of Clindamycin Vs metronidazole for the~     treatment of abnormal vaginal flora in high risk pregnancies. For this purpose, pregnant~     women who are considered high risk for preterm labor and were diagnosed with abnormal vaginal~     flora will be randomly treated either with clindamycin or metronidazole. Eradication of the~     abnormal flora and adverse effects will be monitored and compared~   "
140925|NCT01722695|"~     The purpose of the study is to show equivalent performance of the Revaclear dialyzer when~     compared to a dialyzer with larger membrane surface area.~      Study design: open, randomized, cross-over, multicentric, controlled prospective~      Medical devices: Revaclear 200 versus FX 60 or Revaclear 400 versus FX 100, depending on~     patient needs~      Patients/sample size: 30 adult chronic hemodialysis patients~      Treatment: Each patient will be treated by hemodialysis for one week (3 dialysis sessions)~     with Revaclear dialyzers and one week (3 dialysis sessions) with FX dialyzers.~      Objectives: intraindividual comparison of dialysis dose; reduction rates and total removal of~     urea, phosphate, creatinine and ß2-microglobulin; albumin loss~      Primary variable: dialysis dose Kt/V urea~      Secondary variable: reduction rates and total removal of urea, phosphate, creatinine and~     ß2-microglobulin~      Safety variable: albumin loss, blood count~   "
140926|NCT01722682|"~     The goal of this study is to evaluate safety and efficacy of bone marrow (BM) as site for~     pancreatic islet transplantationin humans. Our hypothesis is that BM represents a better site~     than liver (currently the location of choice for this procedure) thanks to its potential~     capacity to favor islet engraftment. To address our hypothesis we propose herein a randomized~     phase II trial to compare BM and liver as sites for islet transplantation in T1D patients.~   "
140927|NCT01722669|"~     The goal of this study is to evaluate how much quercetin or isoquercetin is absorbed after a~     single dose and evaluate for pharmacokinetic inhibition of protein disulfide isomerase.~     Pharmacodynamic studies will also be performed in an additional cohort of 10 patients with~     evidence of antiphospholipid antibodies~   "
140928|NCT01722656|"~     This study will evaluate the use of intravitreal aflibercept (anti-VEGF therapy) in patients~     with a type of macular degeneration known as vascularized pigment epithelial detachment.~     Previous studies have shown a generally poor outcome in treating this difficult to treat form~     of wet macular degeneration. More recently, multiple pilot studies have shown positive~     benefits to using anti-VEGF therapy. This study will evaluate the safety and efficacy of~     treating vascularize pigment epithelial detachment associated with wet macular degeneration~     with intravitreal aflibercept injection.~   "
140929|NCT01722643|"~     The overall goal of this project is to develop a novel family friendly intervention that will~     help teens with poor metabolic control of their type 1 diabetes increase and sustain daily~     self monitoring of blood glucose and lower HbA1c. This is important because poor metabolic~     control has long-term health implications. This project will provide important information~     regarding new effective ways to improve outcomes among teens with poorly controlled type 1~     diabetes.~      Primary hypotheses are that the intervention, MAxIM, will: (1) help teens improve and~     maintain glucose control, and (2) improve decision making (improve executive function and~     reduce delay discounting), which will predict treatment outcome.~   "
140930|NCT01722630|"~     Aim of this study was to investigate the cardiac and renal responses to the administration of~     different amount of crystalloids, with and without dopamine, during gynaecological~     laparoscopic surgery.~   "
140931|NCT01722617|"~     Rheumatoid arthritis (RA) is a rheumatic inflammatory synovitis characterized by pain and~     joint swelling as well as thickening synovial (pannus) lesions that are responsible of~     osteocartilaginous and tendon damage. It evolves in spurts or long and variable intensity~     interspersed with remissions.~      The effectiveness of treatment is based on the proportion of patients who achieve a certain~     degree of improvement over the initial level of various parameters such as response criteria~     ACR 20, 50 or 70% or EULAR based on the evolution of DAS 28 or DAS 44. These response~     criteria are now well validated but do not fully take into account the improvement of the~     patient's condition. In contrast, there is no questionnaire to identify the proportion of~     patients whose RA worsened between the medical visits. Such a questionnaire is necessary to~     detect flares outbreaks in daily practice and in randomized clinical trials, follow-up~     studies or longitudinal studies after drugs marketing to detect a reversal of disease~     activity.~      Both STPR group and OMERACT group have each developed such a new self-administered~     questionnaire (FLARE and OM-RA-FLARE) to detect the flare- in RA patients.~      The objective of this study is to validate the questionnaires FLARE and OM-RA-FLARE among RA~     patients using the methodology advocated by the OMERACT in terms of validity (truth),~     discriminating power (discrimination) and feasibility~   "
140932|NCT01722604|"~     The main purpose of this prospective study is to demonstrate the therapeutic equivalence of~     topical brinzolamide compared with AzoptTM~   "
140933|NCT01722591|"~     A prospective, multicenter, uncontrolled study to evaluate the safety and efficacy of the~     Cardiapex percutaneous trans-apical access and closure system. The Cardiapex device intended~     for percutaneous access and closure of the left ventricular apex in conjunction with~     transapical Transcatheter Aortic Valve Implantation (TAVI).~   "
140934|NCT01722578|"~     Hepatic encephalopathy (HE) is a potentially reversible functional disorder of the brain with~     neurological and psychiatric symptoms. HE occurs in up to 70% of patients with cirrhosis at~     some time during the course of disease. The chief neurotoxin implicated in the development of~     HE is ammonia. An important aim of treatment of HE is the reduction of the ammonia in the~     body by lowering the amount of ammonia produced and increasing its detoxification. Enteric~     production of ammonia can be decreased by non-absorbable disaccharides such as lactulose and~     antibiotics such as rifaximin. L-ornithine- L-aspartate (LOLA), the salt of the natural amino~     acids ornithine and aspartate acts through the mechanism of substrate activation to detoxify~     ammonia. In clinical trials, LOLA has shown a statistically significant effect with respect~     to reduction in HE grade, reduction of blood ammonia concentration and positive effects on~     psychomotor function in patients of cirrhosis with minimal HE and overt chronic Grade I HE,~     as compared to placebo. However, there is lack of data on the efficacy of LOLA in patients~     with overt acute hepatic encephalopathy which is one of the major causes of hospital~     admissions and resource utilization in decompensated cirrhotics. Each admission for HE causes~     a major financial loss to the family and financial burden on the society. Any drug which~     decreases the hospital stay by rapidly improving HE, will clearly lead to decreased hospital~     costs to the individual and the society as a whole. Hence, such a trial is a national~     priority. The investigators hypothesize that LOLA, if added to the standard treatment of~     overt acute HE (i.e lactulose), may lead to a faster recovery and decrease in hospital stay~     of these patients. In this prospective, randomized, placebo controlled trial, the~     investigators aim to evaluate the efficacy of intravenous L-ornithine, L-aspartate in~     reversal of overt acute hepatic encephalopathy in patients with liver cirrhosis.~   "
140935|NCT01722565|"~     Introduction: parastomal hernia (PH) is a frequent complication after an ostomy, despite the~     many prevention and treatment techniques that have been described. Since the introduction of~     laparoscopy, the frequency of PH is even higher than in open surgery. This type of hernia~     remains a surgical problem of considerable importance, requiring significant consumption of~     public health and economic resources, and representing a major alteration of the quality of~     life of these patients.~      Objective: to evaluate the effectiveness of the insertion of a prosthesis to prevent PH in~     elective surgery for laparoscopic abdominoperineal resection.~      Methodology: prospective, multidisciplinary, multi-center randomized controlled study.~     Control group: Rectal neoplasms undergoing elective surgery for laparoscopic abdominoperineal~     resection. Study group: Rectal neoplasms undergoing elective surgery for laparoscopic~     abdominoperineal resection with a lightweight mesh (polypropylene and poliglecaprone 25).~     Sample size was calculated based on a proportion of parastomal hernia of 65% in the control~     group and 15% in the study group. With an α risk =0.05 and 1- β= 0.8, 28 patients are~     required, 14 per group. Estimating a drop-out rate of 10%, the final number will be 32~     patients. The efficacy will be evaluated clinically at six months and abdominal CT will be~     performed at 12 months along with another clinical evaluation.~   "
140936|NCT01722552|"~     The CATS project is designed to increase understanding of interventions that are feasible and~     effective in helping injection drug users (IDU) or other patients at high risk of poor~     medication adherence who are HIV-positive to maintain a high ART adherence. The study will~     involve: assessing the feasibility and acceptability of using real-time feedback, a wireless~     technology-updated adaptation of an approach the investigators found to be feasible and~     effective in China, to promote ART adherence among Chinese patients, including IDU;~     generating preliminary effectiveness data of real-time feedback on adherence, CD4 count, and~     HIV viral load; and identifying the factors that explain how real-time feedback influences~     intervention success or failure.~      The specific aims of the study are:~      SA1: Determine the feasibility and acceptability of using real-time feedback, a wireless~     technology-updated adaptation of an approach we found to be feasible and effective in China,~     to promote ART adherence among Chinese patients. The investigators will conduct a pilot RCT~     of the real-time feedback intervention among Chinese patients in order to assess its~     feasibility and acceptability in this population.~      SA2: Generate preliminary effectiveness data of real-time feedback on adherence, CD4 count,~     and HIV viral load. The RCT will allow the researchers to generate rigorous estimates of~     effect sizes on these important endpoints.~      SA3: Describe the factors that explain how real-time feedback influences intervention success~     or failure. The investigators will use a quantitative-qualitative mixed-methods research~     approach to explore how the intervention influences the experience of adherence support in~     this patient population.~   "
140937|NCT01722539|"~     Considering the facts that: (i) IPT of malaria provides substantial protection against~     anaemia and malaria in school children (ii); SP resistance has no significant impact on the~     prophylactic efficacy (iii) SP-PQ is safe and as efficacious as SP: the investigators~     hypothesize that antimalarial IPT with SP and SP-PQ will improve haemoglobin concentration,~     reduce anaemia prevalence, malaria incidence and parasitaemia, and improve malnutrition and~     school performance in school-aged children of Congo.~   "
140938|NCT01722526|"~     To evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic profile of rhASM~     in adult patients with Acid Sphingomyelinase Deficiency (ASMD) following repeated-dose~     administration.~   "
140939|NCT01722513|"~     The aim of this prospective, randomized, controlled study is to investigate the effect of~     pretreatment with intravenous Alprostadil on the incidence of CIN in a high-risk population~     of patients with both type 2 diabetes mellitus (T2DM) and CKD undergoing coronary~     angiography, and evaluate the influence of such potential benefit on short-term outcome.~   "
140940|NCT01722500|"~     The primary aim of the International Study of Childhood Obesity, Lifestyle and the~     Environment (ISCOLE) is to determine the relationship between lifestyle characteristics and~     obesity in a large multi-national study of 10 year-old children, and to investigate the~     influence of behavioral settings and physical, social and policy environments on the observed~     relationships within each country.~   "
140941|NCT01722487|"~     A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase~     Inhibitor PCI-32765 versus Chlorambucil in Patients 65 Years or Older with Treatment-naive~     Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.~   "
140942|NCT01722474|"~     The ASI Non-Invasive Arterial Stiffness Screening Device (ASI Device) is an investigational~     device under development for the non-invasive assessment of arterial stiffness. The ASI~     Device is considerably smaller and more cost effective than its commercially available~     counterparts. As the device is readily portable, it is intended to be targeted for use in the~     community (or at home), as opposed to within the hospital or clinic setting only. However, as~     the device is still under development, it is not known whether it is capable of determining~     arterial stiffness with the same sensitivity and consistency as those already in commercial~     use. An added variable is the fact the sensor for the ASI Device is located on the fingertip.~      Validation is a prerequisite for obtaining Health Canada approval of devices for diagnostic~     purposes. The ASI Device has not been tested against other instruments capable of providing~     similar measurements. Therefore, a clinical trial to compare the ASI Device against similar~     devices is necessary. The study will compare measurements of arterial stiffness and other~     central haemodynamic parameters obtained with the ASI Device against similar measurements~     from devices that have already been approved for this purpose by Health Canada/United States~     Food and Drug Administration (FDA).~   "
140943|NCT01722461|"~     This is a prospective, multi-center, randomized, double-blinded study. Subjects enrolled will~     be randomly assigned to receive either active treatments for axillary hyperhidrosis with the~     Ulthera System in both axillas, or sham treatments, also with the Ulthera System but with the~     energy settings on the device set to deliver no ultrasound energy. Subjects will be~     randomized in a 2:1 ratio, with 2 subjects randomized to active treatment for every one~     subject randomized to sham treatment. Subjects will receive 2 study treatments 30 days apart.~      Subjects and study personnel conducting efficacy measures will be blinded to the assigned~     treatment groups. The study hypothesis is that subjects in the active treatment group will~     have a greater reduction in underarm sweating compared to those in the sham group as measured~     by a quality of life questionnaire.~      All subjects will undergo follow-up assessments at 14 days and 30 days from the date of their~     first study treatment, and 14 days, 30 days, 3 months and 6 months from the date of their~     second study treatment. Subjects in the active treatment group will also undergo follow-up~     assessments at 9 months and 12 months from the date of their second study treatment.~   "
140944|NCT01722448|"~     The investigators want to find out whether a choline supplement can protect muscle health in~     young men with very common genetic vulnerabilities. Men, who respond to a brief, but intense~     set of arm exercise and have a common genetic profile, will be asked to use a choline~     supplement for three weeks and a placebo for three weeks. Before the begin of the~     supplementation study and after 3 and 6 weeks the investigators will test response to the~     exercise challenge and ask that all consumed foods are recorded.~   "
140965|NCT01722175|"~     This randomized phase II trial compares how well associating liver partition with portal vein~     ligation for staged hepatectomy (ALPPS) or portal vein occlusion (PVO) works in treating~     patients with liver cancer. Both treatments are types of 2-stage hepatectomies for removing~     liver cancer. ALPPS may be more effective than PVO in patients whose disease would~     traditionally be considered inoperable.~   "
140945|NCT01722435|"~     Only limited information on the process of completing long-term opiate substitution treatment~     (OST) with substances like methadone exist. Furthermore, systematic knowledge from scientific~     studies is scarce, there are only few studies with respect to treatment completion or regular~     termination (mainly catamnestic analyses). Studies by Nordt et al. (2004) or Nordt & Stohler~     (2006) show an estimated rate of 10% of patients per year who terminate OST by means of~     tapering the substitution agent or changing into withdrawal treatment in specialized clinics.~     It is state of the art that an indication for termination of OST has to be based on a common~     agreement between the patient and the doctor. Furthermore, the patient should live in a~     stable social situation and the state of health had markedly improved. Finally, the patient~     has to be free of (illegal) drug use for at least 6 months and the individual aims of~     treatment should have been reached (Vader et al. 2003).~      The main objective of the prospective and explorative study is the systematic description of~     the process of termination of OST. With a comparison between patients who complete OST~     regularly and patients who terminate treatment prematurely (or are still in treatment)~     predictors of positive termination of OST can be identified.~      Patients treated with methadone or levomethadone of 5 general practitioners' practices and 2~     specialized clinics who might be able to terminate OST during the next 12 months from the~     doctors' perspective can take part in the study. In addition to baseline examination further~     assessments take place every 3 months (i.e. after 3, 6, 9 and 12 months). The questionnaires~     include state of health, well-being, social situation as well as drug and alcohol use.~     Furthermore, the treating doctors are asked every 3 months to fill out questionnaires on~     infections and other disorders, clinical characteristics, dosage process and drug use~     (measured by urine samples).~      Patients who will be successful in completing OST during the observational period will be~     compared with the remaining cases.~      Finally, a 6-month follow-up is planned in order to investigate the stability and maintenance~     of the situation at month 12.~   "
140946|NCT01722422|"~     Assessment of the effect of hyperoxia and hypertonic saline on survival in patients with~     septic shock Hyperoxia and hypertonic saline may have beneficial effects on organ perfusion~     and oxygenation and may reduce the organ failure occurences. To date, only scarce data are~     available. Side effects are not well described. Therefore we designed a randomized clinical~     trial in order to assess the early administration of hypertonic saline and oxygen in the very~     early beginning of septic shock.~   "
140947|NCT01722409|"~     The investigators designed a double-blind, randomized placebo-controlled study to determine~     the effects of dexmedetomidine on the recovery characteristics of patients who were scheduled~     to undergo endovascular coil embolization.~   "
140948|NCT01722396|"~     Previous studies of vitamin D supplementation have suggested there may be differences in~     response between individuals. This study is an open label study of vitamin D supplementation~     in patients with active or latent tuberculosis in which active disease patients take~     100000units of vitamin D every 8 weeks during their tuberculosis treatment. Genotyping for~     relevant vitamin D pathway polymorphisms will be carried out and related to clinical and ex~     vivo markers of vitamin D response. Latent patients will only be studied for vitamin D~     response ex vivo. Our hypothesis is that response to vitamin D in both monocytes and T cells~     will be related to polymorphisms in the DBP gene, and that this may relate to clinical~     response in terms of post supplementation vitamin D level.~   "
140949|NCT01722383|"~     Chronic kidney disease (CKD) affects up to 16% of the adult population and is associated with~     significant morbidity and mortality. People at highest risk from progressive CKD are defined~     by a sustained decline in estimated glomerular filtration rate (eGFR) and/or the presence of~     significant albuminuria/proteinuria. Accurate mapping of the bio-clinical determinants of~     this group will enable improved risk stratification and direct the development of better~     targeted management for people with CKD. To address these requirements we have established~     the Renal Impairment in Secondary Care (RIISC) study; RIISC is enrolling a cohort of patients~     at high risk from progressive CKD and compiling a comprehensive and detailed bio-clinical~     phenotype, including vascular and oral health phenotyping, at enrolment and on subsequent~     follow-up.~   "
140950|NCT01722370|"~     Patients with chronic obstructive pulmonary disease (COPD) may develop low oxygen levels,~     because of damage to their lungs. Long term oxygen therapy (LTOT) is given for at least 15~     hours per day, and has established indications and benefits in COPD. However, the indications~     for and benefits from ambulatory oxygen supplementation (oxygen just when walking or~     exercising) are less well understood, in part due to heterogeneity of previous study designs,~     and lack of long term follow up. This is a pilot study of supplementary ambulatory oxygen in~     COPD, which allows us to ascertain mechanisms of disease by measuring their degree of~     systemic inflammation pre and post oxygen supplementation, and measuring changes in gene~     expression in muscles by means of microarray profiling. Secondly, our study will utilise~     follow up of clinical parameters including home activity monitoring to ascertain medium/long~     term benefits of oxygen supplementation in a real life setting. Our hypothesis is that~     exertional hypoxia results in muscle dysfunction and this could be prevented by oxygenation.~   "
140951|NCT01722357|"~     The purpose of the study is to address 3 main sets of questions in the bariatric surgery~     population. 1) Does bariatric surgery, without any other intervention, lead to increased~     physical activity and improved physical fitness? 2) Does wearing a pedometer lead to~     increased physical activity in obese individuals prior to and/or after bariatric surgery?~     Does the increased activity result in improvements in physical fitness? 3) Does physical~     activity counseling increase physical activity prior to and or/after bariatric surgery? Does~     the increased activity result in improvements in physical fitness? The overall goal of the~     study is to determine the impact of bariatric surgery on physical activity and assess the~     utility of additional interventions to help postoperative patients adopt a more active~     lifestyle. Participants are randomized to usual care, pedometer use, or pedometer use plus~     exercise counseling before and for the first 6 months after bariatric surgery. In an~     extension of the primary study, from 1 to 5 years after surgery, all patients receive~     exercise counseling. Physiological measures will be assessed to determine whether bariatric~     surgery and/or improved physical activity levels result in improved physical fitness.~   "
140952|NCT01722344|"~     The purpose of this study is to investigate the efficacy of IPS in Denmark and compare~     effects of 1. Individual Placement and Support (IPS) vs. 2. IPS + cognitive remediation and~     work-related social skills training vs. 3. standard intervention, among individuals with~     severe mental illness.~   "
140953|NCT01722331|"~     This study is being conducted to evaluate the efficacy and safety/tolerability of~     subcutaneous MK-3222, followed by an optional long-term safety extension study, in~     participants with moderate-to-severe chronic plaque psoriasis.~   "
140954|NCT01722318|"~     This is a randomized, 12-week, double-blind, placebo-controlled, dose-ranging study in~     patients with IBS-C.~   "
140997|NCT01721759|"~     The purpose of the study is to assess the objective response rate (change in tumor size from~     baseline) in patients with advanced or metastatic squamous cell nonsmall-cell lung cancer~     treated with Nivolumab (BMS-936558) after failure of 2 prior systemic regimens~   "
140955|NCT01722305|"~     This phase I trial studies the side effects and best dose of pomalidomide when given together~     with dexamethasone in treating patients with primary central nervous system lymphoma that has~     come back (relapsed) or does not respond to treatment (refractory) or intraocular lymphoma~     that is newly diagnosed, relapsed or refractory. Pomalidomide may stimulate the immune system~     to kill cancer cells. Drugs used in chemotherapy, such as dexamethasone, work in different~     ways to stop the growth of cancer cells, either by killing the cells, stopping them from~     dividing, or by stopping them from spreading. Giving pomalidomide together with dexamethasone~     may kill more cancer cells.~   "
140956|NCT01722292|"~     The purpose of this study is to find a recommended dose of LY2940680 that can be safely given~     in combination with etoposide and carboplatin followed by LY2940680 alone in participants~     with extensive-disease small cell lung cancer. The study will also compare progression-free~     survival in participants who are administered etoposide, carboplatin and LY2940680 followed~     by LY2940680 alone versus etoposide, carboplatin, and placebo followed by placebo alone.~   "
140957|NCT01722279|"~     The primary purpose of this study is to examine the breadth, nature, and factors affecting~     the long term changes in physical and psychological health and quality of life (QOL)~     following bariatric surgery. Data will be gathered via electronic survey (SurveyMonkey),~     postal mail, or phone, or using a standardized questionnaire expected to last 25-35 minutes.~     Archival data available from patient medical records will also be gathered.~   "
140958|NCT01722266|"~     Hypothesis 1: Treatment with Liraglutide in patients with type 1 diabetes decreases fasting,~     postprandial and the overall mean glucose concentrations.~      Aim 1.1: To compare the mean fasting, the mean weekly glucose and the standard deviation of~     weekly blood glucose concentrations as recorded by continuous glucose monitoring prior to and~     following 6 weeks and 12 weeks of treatment with 0.6, 1.2 and 1.8 mg of liraglutide daily. In~     addition, the time spent at glucose concentrations >150 and 200mg/dl and <70 and <40 mg/dl~     will also be compared.~      Aim 1.2: To compare the postprandial glucose concentrations following a test meal before and~     after 12 weeks of treatment with 0.6, 1.2 and 1.8 mg of liraglutide daily. Glucose~     concentrations will be measured as areas under the curve for the data obtained from the meal~     challenge.~      Aim 1.3: To compare HbA1c levels(glycated hemoglobin) before and after 12 weeks of treatment~     with 0.6, 1.2 and 1.8 mg of liraglutide daily Hypothesis 2: Treatment with Liraglutide in~     patients with type 1 diabetes decreases postprandial glucagon concentrations and increases~     postprandial C-peptide concentrations.~      Aim 2.1: To compare fasting and postprandial glucagon and C-peptide concentrations following~     a test meal before and after 12 weeks of treatment with 0.6, 1.2 and 1.8 mg of liraglutide~     daily.~      Hypothesis 3: Treatment with Liraglutide in patients with type 1 diabetes delays gastric~     emptying.~      Aim 3.1: To compare the gastric emptying as measured by acetaminophen absorption before and~     after 12 weeks of treatment with 0.6, 1.2 and 1.8 mg of liraglutide daily.~   "
140959|NCT01722253|"~     The purpose of this study is to determine whether electroacupuncture is a effective tool to~     the postoperative analgesia~   "
140960|NCT01722240|"~     The control of glucose homeostasis in subjects with type 1 diabetes is fragile since~     exogenous insulin cannot compensate for changing requirements and is not precise either in~     terms of the dose or the bio-availability of the insulin injected. Furthermore, in the near~     total absence of insulin secretion, the physiological post prandial inhibition of glucagon~     secretion by the α-cell is also probably deficient in all type 1 diabetics. Thus, there is a~     need for therapies beyond insulin that can further improve glycemic control and reduce~     fluctuations in glucose in these subjects. The investigators have recently shown that~     Liraglutide, a glucagon like peptide (GLP)-1 analogue with duration of action of 24 hours,~     when added to insulin in subjects with well controlled type 1 diabetes reduces mean and~     standard deviation of blood glucose, HbA1c and insulin requirements. Since C-peptide~     concentrations did not alter following Liraglutide, it is likely that the suppression of~     glucagon may have contributed to this effect. The glucose lowering effects of GLP-1 agonists~     are well established in subjects with type 2 diabetes, however, these have not been studied~     prospectively in subjects with type 1 diabetes. The investigators have, therefore, designed~     this study to investigate the central hypothesis that in patients with type 1 diabetes,~     Liraglutide has a glucose lowering effect. A major secondary objective of this study is to~     elucidate the mechanisms responsible for its glucose lowering effects and those involved in~     reducing the insulin dose. The specific aims of this proposal are:~      Hypothesis 1: Treatment with Liraglutide in patients with type 1 diabetes decreases HbA1c,~     fasting, postprandial and the overall mean glucose concentrations while decreasing the dose~     of insulin required.~      Aim 1.1: To compare the HbA1c, mean fasting, glucose, mean weekly glucose, standard deviation~     of weekly blood glucose concentrations as recorded by continuous glucose monitoring and the~     dose of insulin required prior to and following 52 weeks of treatment with 1.8 mg of~     liraglutide daily.~      Aim 1.2: To compare the postprandial glucose concentrations following a test meal before and~     after 52 weeks of treatment with 1.8 mg of liraglutide daily.~      Hypothesis 2: Treatment with Liraglutide in patients with type 1 diabetes decreases basal and~     postprandial glucagon concentrations and increases basal and postprandial C-peptide~     concentrations.~      Aim 2.1: To compare the basal and postprandial glucagon and C-peptide concentrations~     following a test meal before and after 52 weeks of treatment with 1.8 mg of liraglutide~     daily.~      Hypothesis 3: Treatment with Liraglutide in patients with type 1 diabetes delays gastric~     emptying.~      Aim 3.1: To compare the gastric emptying as measured by acetaminophen absorption before and~     after treatment with 1.8 mg of daily subcutaneous liraglutide.~   "
140961|NCT01722227|"~     This is the first prospective randomized double-blind placebo-controlled study to investigate~     the effect of a GLP-1 analog, specifically liraglutide, on blood glucose levels and~     variability in subjects with type 1 diabetes treated with insulin. Liraglutide is the~     preferred GLP-1 analog for this study because the pharmacokinetics and pharmacodynamics of~     the drug are consistent with a sustained duration of action. The current gold standard for~     management of type 1 diabetes is based on insulin replacement with novel analogs with~     specified pharmacodynamic profiles or with unique insulin delivery systems (insulin pump~     therapy). No other adjuvant therapy has demonstrated sustained benefit in this population.~     This study will also investigate the effect of liraglutide on suppression of glucagon~     secretion during meal challenges. This is of particular importance since, in the absence of~     insulin secretion from the β-cell, there is no paracrine inhibition of glucagon secretion by~     the α-cell. Dysregulation of glucagon secretion may impact the glycemic control and overall~     pathogenesis in those with type 1 diabetes. The use of CGM technology in this study will~     allow us to determine the rapidity, consistency, and sustainability of any response to~     liraglutide.~   "
140962|NCT01722214|"~     This study is a double-blinded randomized multicenter placebo controlled trial to determine~     the effect of adalimumab on vascular inflammation (ascending aorta and carotides) in patients~     with moderate to severe psoriasis.~   "
140963|NCT01722201|"~     This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single~     dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence~     between Test Product and the corresponding Reference Product under fasting condition in~     normal, healthy, adult human subjects.~   "
140964|NCT01722188|"~     This is a prospective, multi-center, actively monitored, long term data collection registry.~     Any Patient that receives a market released St. Jude Medical (SJM) Optim lead and a~     compatible market released cardia rhythm management (CRM) implantable pulse generator is~     eligible for enrollment into the registry.~   "
140998|NCT01721746|"~     The purpose of the study is to estimate the response rate and compare overall survival of~     patients taking BMS-936558 to those taking study physician's choice of either Dacarbazine or~     Carboplatin and Paclitaxel~   "
140966|NCT01722162|"~     This randomized phase II trial studies how giving a drug called levocetirizine to patients~     with colorectal cancer affects their tumor response to capecitabine and bevacizumab.~     Capecitabine is a chemotherapy drug that blocks tumor growth by disrupting DNA and RNA~     synthesis and repair (cell division and survival). Bevacizumab is a monoclonal antibody that~     blocks the ability of tumors to grow and spread by inhibiting the growth of blood vessels~     that feed them. Patients with colorectal cancer can develop a resistance to the effects of~     bevacizumab. Levocetirizine may decrease tumor resistance to bevacizumab. Giving bevacizumab,~     capecitabine, and levocetirizine dihydrochloride together may be an effective treatment for~     refractory colorectal cancer.~   "
140967|NCT01722149|"~     MPM patients are not eligible for surgical procedures like decortication or~     pleuro-pneumectomy and have a median survival of 12 months with palliative chemotherapy.~     Therefore, new therapeutic approaches are of crucial need in this clinical situation. This is~     a phase I trial for patients with malignant pleural mesothelioma with pleural effusion~     testing the safety of a fixed single dose of 1x10e6 adoptively transferred FAP-specific~     re-directed T cells given directly in the pleural effusion. Lymphocytes will be taken 21 days~     before transfer from peripheral blood. CD8 positive T cells will be isolated and~     re-programmed by retroviral transfer of a chimeric antigen receptor (CAR) recognizing FAP~     which serves as target structure in MPM.~        -  Trial with immunomodulatory product / biological~   "
140968|NCT01722136|"~     The overall goal is to determine whether any energy expenditure compensation in response to~     16 weeks of aerobic exercise at a higher-dose is greater compared to a lower-dose~     intervention in older women, and to begin to investigate underlying physiological mechanisms~     that influence energy expenditure changes in older women.~   "
140969|NCT01722123|"~     Decision making capacity fatigues after repeated decisions similar to skeletal muscle. The~     result is decision fatigue, in which subsequent decisions are altered toward the status quo.~     Patients are at risk for decision fatigue yet it has not been studied. The Investigator~     proposes a randomized study in the outpatient setting in patients at high risk for needing to~     make complex decisions, in an effort to determine the impact of decision fatigue on~     participant self-control and subsequent choices.~   "
140970|NCT01722110|"~     This is a randomized, balanced, open Label, two-treatment, two-period, two-sequence, single~     dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence~     between Test Product and the corresponding Reference Product under fed condition in normal,~     healthy, adult, male and female human subjects.~   "
140971|NCT01722097|"~     The purpose of this study on laparoscopic hysterectomy is to investigate postoperative pain.~     Patients are allocated to either deep neuromuscular blockade and low intra-abdominal pressure~     (8 mmHg) or moderate neuromuscular blockade and usual intra-abdominal pressure (12 mmHg).~      Primary hypothesis:~      Deep neuromuscular blockade and low intra-abdominal pressure (8 mmHg) reduces postoperative~     pain compared to moderate neuromuscular blockade and intra-abdominal pressure (12 mmHg).~   "
140972|NCT01722084|"~     Adolescents in Latin America are at major risk for unwanted pregnancies leading to unsafe~     abortions and maternal health risks. Mostly, adolescent health programmes tend to focus on~     unidirectional interventions aiming at a single determinant of adolescents´ sexual and~     reproductive health. However, evidence exists that a complex health problem should be~     addressed by an equally nuanced and multipronged response. Knowledge is lacking on how to~     develop a comprehensive approach to promote adolescents' sexual health.~      The CERCA study will conduct an implementation based on the hypothesis that a comprehensive~     strategy of community-embedded interventions helps to improve the sexual health of~     adolescents. We will test this hypothesis and describe the development, implementation and~     testing of interventions in three Latin American cities: Cochabamba (Bolivia), Cuenca~     (Ecuador) and Managua (Nicaragua).~      The research methodology has been designed based on the methodological frameworks of action~     research, community based participatory research and intervention mapping.~      The interventions are complex addressing different target groups (adolescents, parents,~     authorities and health providers) and focussing on various behaviours that are related to~     communication about sexuality, information seeking, access to health care and safe sexual~     intercourse.~      For the evaluation of effectiveness a randomised and non-randomised controlled study was~     developed for respectively Managua and the two other cities. Furthermore a process evaluation~     is conducted.~      This research will result in a framework that will contribute to the planning of~     interventions that are effective and responsive to adolescents' sexual health needs.~   "
140973|NCT01722071|"~     The proposed study will investigate the effects of intranasal oxytocin administration on~     neural activity associated with social and non-social motivation.~   "
140974|NCT01722058|"~     You are invited to participate in a research study to develop new ways to look for abnormal~     areas/tissues of the colon. The current endoscopes used to look at the colon are very good,~     but if the area doesn't look different to the naked eye, then the endoscope can't improve on~     that. We are looking at using special fluorescent stains in addition to special endoscopes~     designed to see abnormal areas that are not obvious to the naked eye. Currently specialized~     microscopes and fluorescent stains are used in clinical laboratories but it takes several~     days of processing to get results. It may be very helpful to look for areas to sample for~     abnormal tissue during the endoscopy procedure.~      You are being asked to let us spray a fluorescent peptides into your right colon. Peptides~     are small chains of amino acids (the building blocks that make up proteins) linked together.~     Our peptide is a chain of 7 amino acids attached to a fluorescent dye called FITC (like the~     one used by your eye doctor).~      We have prepared this special fluorescent peptide to target and bind to any abnormal areas~     if present, and glow when a special light is used. In this study, we will apply the special~     fluorescent peptide by a spray catheter to your right colon to asses for safety. The~     colonoscope used in this study is the usual colonoscope used and is not able to see the~     fluorescence.~      This is a phase 1 study. This means that this is the first time we have used this kind of~     fluorescent peptide in people. The Food and Drug Administration (FDA) has not approved this~     agent, but is allowing us to test it in this study. The goal of this study is to see if there~     are any side effects from using the peptide. We have used a similar peptide that we've~     developed for the esophagus in over 40 patients without any side effects.~      This is the first test of this agent, so it won't be used to change how colonoscopy is done.~   "
140975|NCT01722045|"~     This is a phase 4, open-label, single arm, multicenter, clinical study in patients with~     neovascular AMD designed to evaluate the efficacy and safety of Intravitreal Aflibercept~     Injection (IAI) administered over 2 years , and to provide clinical information from the~     first year in the trial evaluating the adverse effects, if any, on the corneal endothelium~     following administration of IAI.~   "
140999|NCT01721733|"~     The purpose of this study is to evaluate the effects of EPI-743 in children with Leigh~     syndrome on disease severity, neuromuscular function, respiratory function, disease morbidity~     and mortality and disease associated biomarkers.~   "
140976|NCT01722032|"~     Background: Many unhealthy dietary and physical activity habits that foster the development~     of obesity are established by the age of five. Presently, approximately 70 percent of~     children in the United States are currently enrolled in early childcare facilities, making~     this an ideal setting to implement and evaluate childhood obesity prevention efforts. We~     describe here the methods for conducting an obesity prevention intervention randomized trial~     in the child care setting.~      Methods/Design: A randomized, controlled obesity prevention trial in 28 low-income,~     ethnically diverse child care centers located throughout Miami-Dade County, FL is currently~     being conducted over two years (2010-present) to test the efficacy of an intervention that~     poises teachers and parents as lifestyle change agents. The Healthy Caregivers-Healthy~     Children (HC2) program includes a curriculum focusing specifically on healthy food choices,~     increased exercise, and role modeling. The program targets food policy changes throughout the~     school, and via the child, caregiver, and teacher. Major outcome measures include child body~     mass index percentile and z score, fruit and vegetable and other nutritious food intake, and~     amount of physical activity.~      Discussion: Although few attempts have been made to prevent obesity during the first years of~     life, this period may represent the best opportunity for obesity prevention. Findings from~     this investigation should inform both the fields of childhood obesity prevention and early~     childhood research about the effects of an obesity prevention program housed in the childcare~     setting. (H1) A child care center-based obesity prevention intervention program that includes~     a teacher and parent nutritional gatekeeper and role modeling program will be more effective~     in maintaining BMI in 3-5 year olds compared to a control group.~      (H2) Role modeling (teacher and parent) will be identified as a significant mediator in~     preventing obesity among intervention children versus controls.~      (H3) A child care center-based multi-level obesity prevention intervention program will~     improve child nutrition (increased consumption of fruits and vegetables, decreased~     consumption of sweetened beverages) and increase physical activity level compared to a~     control group.~   "
140977|NCT01722019|"~     Endovenous ablation of the greater saphenous vein has nowadays the same outcome as open~     crossectomy and stripping. The two most performed techniques for endovenous ablation are the~     endovenous laser ablation and the radiofrequency ablation. According to the trial of~     Rasmussen, they are equivalent for occlusion but the lower laser wave lengths resulted in~     more pain and paresthesia. The newer wave length of 1470 nm showed lesser side effects in~     observational studies. The aim of this study is to compare radiofrequency ablation with the~     VNUS closure fast ® with laser ablation with a 1470 nm wave length in combination with a new~     fiber, the Tulip fiber ®. This fiber has the shape of a tulip at his tip which avoids point~     necroses of the vessel wall and on consequence results in lesser side effects from wall~     perforations such as pain, haematoma,…~   "
140978|NCT01722006|"~     Classical conditioning is widely used to study motivational properties of addictive drugs in~     animals, but has rarely been used in humans. Here, we are establishing a procedure suitable~     for studying the neurobiology and individual determinants of classical conditioning in~     humans. Healthy volunteers are randomly assigned to four groups that received methamphetamine~     or placebo in the presence of distinctive environmental cues under paired or unpaired~     conditions. During each session, subjects perform tasks known to activate the ventral~     striatum in fMRI studies. The tasks are performed in the presence of a distinctive context,~     consisting of a screen background image of a beach or of mountains, accompanied by~     corresponding sounds. Separate groups of subjects carry out the tasks under high or low~     reward conditions. Within each of the two reward conditions, one group (paired), receives~     methamphetamine (20 mg, oral) or placebo consistently associated with one of the contexts,~     while the other (unpaired) receives drug or placebo unrelated to context. A fifth group~     (paired) perform the tasks with contextual cues but in the absence of monetary incentives.~     Before and after conditioning, participants carry out a series of forced choice tasks, and~     change of preference over time was analyzed.~   "
140979|NCT01721993|"~     THAR2011-1 is a Phase I, single dose, open-label dose-escalation study to determine the~     safety, absolute bioavailability, dose proportionality, and pharmacokinetics of T121 in~     healthy postmenopausal women. The study is expected to identify a safe dose that can be~     further tested in subsequent multiple dose studies comparing the safety, PK and~     pharmacodynamics (PD) of T121 with the currently marketed IV zoledronic acid (Zometa).~   "
140980|NCT01721980|"~     The purpose of this study is to evaluate the safety and tolerability after multiple ascending~     oral doses of GLPG0974 given to healthy male subjects for 14 days, compared to placebo.~      Furthermore, during the course of the study, the amount of GLPG0974 present in the blood and~     urine (pharmacokinetics) as well as the effects of GLPG0974 on mechanism of action-related~     parameters in the blood and stool samples (pharmacodynamics) will be characterized compared~     to placebo.~      Also, the effect of the compound on glucose tolerance will be explored as well as the~     potential of cytochrome P450 (CYP)3A4 induction by repeated dosing with GLPG0974.~   "
140981|NCT01721967|"~     The purpose of RHYME is to evaluate the safety and efficacy of ranolazine in Hypertrophic~     Cardiomypathy patients with chest pain or dyspnea despite treatment with standard medical~     therapy. This is a small, pilot, open-label (non-randomized) study of an approved drug for~     the treatment of angina in a novel patient population (adult patient population with~     hypertrophic cardiomyopathy).~   "
140982|NCT01721954|"~     This study is a randomized, multi-center study that will compare the efficacy and safety of~     selective internal radiation therapy (SIRT) using SIR-Spheres microspheres plus a standard~     chemotherapy regimen of FOLFOX6m versus FOLFOX6m alone as first-line therapy in patients with~     non-resectable liver metastases from primary colorectal carcinoma.~      Treatment with the biologic agent bevacizumab, if part of the standard of care at~     participating institutions, is allowed within this study at the discretion of the~     Investigator.~   "
140983|NCT01721941|"~     The primary objective of this phase I dose escalation study is to determine the maximum~     tolerated dose of TH-302 when administered with doxorubicin via trans-arterial~     chemo-embolization (TACE) in patients with hepatocellular carcinoma (HCC) who are not~     transplant candidates and have unresectable disease. HCC is the second leading cause of~     worldwide cancer death and is generally incurable without liver transplant. TACE can convert~     about 40% of these patients to transplant candidates. Additionally, in non-transplant HCC~     patients, TACE confers statistical improvements in overall survival. Selective HCC arterial~     catheterization during TACE allows for the delivery of concentrated drugs to the liver tumor~     but the optimal TACE chemotherapy regimen has not yet been determined. TH-302 is a hypoxia~     inducible agent that can be activated in the hypoxic environment induced by TACE.~   "
141083|NCT01720628|"~     Objectives: Behçet's disease (BD) is a systemic vasculitis. Since vascular endothelial~     dysfunction plays a prominent role in the pathogenesis of the disease, we considered~     angiogenic cytokines as an interesting target for investigation in BD. The aim of this study~     was to investigate the possible role of angiogenin, vascular endothelial growth factor (VEGF)~     and basic fibroblast growth factor (bFGF) in the pathogenesis of BD.~      Design and Methods: Sixty five patients with BD and 21 healthy control subjects were included~     in the study. Serum angiogenin, bFGF and VEGF concentrations were determined by using in~     vitro enzyme immunoassay (ELISA) kits according to the manufacturer's instructions.~   "
140984|NCT01721928|"~     The main purpose of the NORIDES study is to investigate the effect of pharmacological~     thromboprophylaxis with low molecular weight heparins (LMWHs) in critically ill patients, and~     how it is affected by presence of acute kidney injury (AKI) and treatment with hemodialysis.~     The main objective is to compare the prophylactic effect of dalteparin in intensive care unit~     (ICU) patients with AKI and Citrate-Calcium dialysis (CiCa-dialysis) with a control group of~     ICU patients with normal kidney function. Our main hypothesis is that CiCa-dialysis reduces~     dalteparin effect, and that patients undergoing CiCa-dialysis do not achieve adequate~     prophylaxis against venous thromboembolism (VTE). The primary endpoint is development of DVT~     during ICU stay, the secondary endpoint inadequate heparin effect measured in blood samples.~   "
140985|NCT01721915|"~     Background: Polycystic ovary syndrome (PCOS) is as common as 5-10% of all women in Austria.~     PCOS women frequently present with metabolic disturbances, hyperandrogenism and infertility.~     New therapy concepts are warranted. In our recent pilot study, vitamin D (vitD)~     supplementation significantly improved glucose metabolism and fertility. However, the~     efficacy of vitD administration shows individual variability indicating endogenous influences~     on pharmacological effects.~      A recent genome-wide association study reported three loci (DHCR7, CYP2R1, and GC) associated~     with vitD insufficiency. Moreover, vitD receptor (VDR) gene variants have already been known~     to be associated with insulin resistance.~      Aim: To test the hypothesis that vitD is efficient in changing metabolic parameters in PCOS~     and non-PCOS women longitudinally and to generate data on pharmacogenetic effects of vitD~     related genetic determinants adjusted for environmental factors.~      Primary outcome: Change from baseline in AUCgluc after vitD treatment. Secondary outcome: To~     generate the hypothesis that changes in metabolic and endocrine parameters following vitD~     treatment are associated with vitD related gene variants.~      Methods: 150 PCOS women with 25-hydroxyvitamin D (cholecalciferol, [25(OH)D]) levels <30~     ng/ml will be treated with vitD (20,000 IU/wk) or placebo in a 2:1 randomized controlled~     trial over 24 weeks and investigated for metabolic and endocrine parameters as well as vitD~     related genetic variants. In addition, 150 non-PCOS women with 25(OH)D <30 ng/ml will be~     treated with vitD (20,000 IU/wk) or placebo in a 2:1 randomized controlled trial over 24~     weeks and investigated for metabolic and endocrine parameters as well as vitD related genetic~     variants. The response to vitD supplementation in both groups will be analysed according to~     genotype profiles.~      Significance: VitD might be a new therapeutic option without major side effects for PCOS~     patients. Exploring specific loci for pharmacogenetic vitD actions would open a new window~     for therapy modulation in PCOS and other metabolic diseases.~   "
140986|NCT01721902|"~     The primary objective of this study is to demonstrate the feasibility and safety of~     intra-operative, intra-myocardial injection of autologous CD133 positive bone marrow cells at~     the time of coronary artery bypass graft (CABG) surgery in patients with chronic ischemic~     cardiomyopathy. Additionally, the feasibility of producing autologous CD133+ bone marrow stem~     cells will be assessed.~      The investigators hypothesize that collection of a sufficient number of CD133+ cells through~     bone marrow aspiration prior to surgery, with subsequent processing and intra-myocardial~     injection of high purity cells following completion of CABG, will be feasible without~     significant adverse clinical consequences.~   "
140987|NCT01721889|"~     The primary objective of this pilot study is to determine the precision of post-operative~     radiostereometric measurements for the assessment of lumbar spinal fusion. This study will~     also determine the potential for RSA as a more precise and accurate means for assessment of~     lumbar spinal fusion and diagnosis of pseudarthrosis.~   "
140988|NCT01721876|"~     To investigate the efficacy, safety, and pharmacokinetics of intravenous volasertib +~     subcutaneous low dose cytarabine in patients >= 65 years of age with previously untreated~     acute myeloid leukaemia, ineligible for intensive remission induction therapy~   "
140989|NCT01721863|"~     Atrial fibrillation (AF) is a common arrhythmia. The proposed patholophysiological mechanisms~     of AF include abnormal electrical conduction in atrium and sympathovagal imbalance with~     increased vagal tone. Patients with AF have poor exercise capacity that may contribute to~     decreased atrial effective refractory period, and decreased cardiac output and heart rate~     reserve, and may result in poor quality of life. Poor endothelial function had been noted in~     patients with AF, associated with increased risks of cerebrovascular and cardiovascular~     disease. Exercise training has been noted to improve exercise capacity and quality of life in~     patients with AF only in some studies. Endothelial function can be improved by exercise~     training in patients with cardiovascular disease, but no report in patients with AF. Evidence~     of exercise training is still needed in patients with AF. The purpose of this study is to~     investigate the effect of exercise training on~        1. endothelial function~        2. heart rate variability~        3. exercise capacity~        4. quality of life.~   "
140990|NCT01721850|"~     The study is conducted to examine the safety and efficacy of a new infant formula and its~     effects on the gastrointestinal tolerance in infants suffering from colic.~      Primary hypothesis to be tested is: an infant formula with optimized composition improves~     colicky symptoms compared to a standard formula.~   "
140991|NCT01721837|"~     Non-interventional, observational study of physicians' use of Dabigatran etexilate for stroke~     prevention in patients with atrial fibrillation and mild to moderate renal impairment~   "
140992|NCT01721824|"~     The aim of the present study, is to evaluate the effect of a supported employment~     intervention, IPS-modified for people with mood and anxiety (IPS-MA) on employment or~     education, when offered to people with onset mood or anxiety disorders who are not likely to~     be able to return to work within three month.~      The hypothesis is that the IPS-MA method is associated with a shorter recovery period and~     more people returning to work or education, compared to treatment as usual.~   "
140993|NCT01721811|"~     The aim of the study is to investigate how the retina adapts to different metabolic~     challenges, e.g. chronic systemic hypoxia, hyperglycemia, special training conditions or~     diets as well as transient changes in the content of oxygen and glucose in the blood.~   "
140994|NCT01721798|"~     This study will inform international medical guidelines as to whether the Levonorgestrel~     intrauterine device (LNG IUD), a highly effective long-acting reversible contraceptive~     method, is safe and acceptable as compared to the copper intrauterine device (C-IUD) for~     HIV-positive women in Cape Town, South Africa. If the LNG IUD is found to be safe and~     acceptable, the introduction of this method to HIV positive women in developing countries~     could significantly reduce unplanned pregnancy and mother-to-child transmission of HIV, and~     confer non-contraceptive benefits to HIV-positive women in Sub-Saharan Africa.~   "
140995|NCT01721785|"~     The purpose of this study is to determine the clinical value of the novel MRI-techniques DWI~     and gadofosveset-enhanced MRI for the management of rectal cancer patients.~   "
140996|NCT01721772|"~     The purpose of this study is to compare the clinical benefit, as measured by overall~     survival, of nivolumab with that of. dacarbazine in patients with previously untreated,~     unresectable, or metastatic melanoma~   "
141000|NCT01721720|"~     Background:~      - Attention deficit hyperactivity disorder (ADHD) is one of the most common and inheritable~     of all neuropsychiatric disorders. It causes problems with attention and impulse control.~     However, the genetic component of ADHD has not been fully studied, including how genes~     interact with the environment. Researchers want to study children and adults who have ADHD.~     They will look at how genetic, brain structure, and environmental factors affect ADHD in~     children and adults.~      Objectives:~      - To study genetic, brain structure, and environmental factors in ADHD in children and~     adults.~      Eligibility:~      - Individuals at least 3 years of age who have ADHD.~      Design:~        -  Participants will be screened with a physical exam and medical history.~        -  Participants will be interviewed about their ADHD. They will also complete behavior and~          psychological tests. Parents or guardians will complete the tests along with~          participants under 18 years of age.~        -  Participants will provide saliva or blood samples.~        -  Participants will also have imaging studies of the brain.~        -  Participants under 25 years of age will return once a year to repeat the tests. Those~          over 25 years of age will have only the one set of tests. Those who are starting~          stimulant drugs and who are receiving behavioral treatment for the first time will also~          have another set of tests 12 weeks after the start of treatment.~   "
141001|NCT01721707|"~     This study is a double-masked, randomized, parallel group study in patients with open angle~     glaucoma or ocular hypertension.~      The aim of this study is to verify the efficacy of the fixed combination of Latanoprost 50~     mcg / mL / brinzolamide 10mg/ml eye drops compared to Latanoprost 50μg/mL eye drops in~     reducing IOP~   "
141002|NCT01721694|"~     To evaluate the efficacy and safety of fixed combination of azithromycin 1.5% + 0.5%~     Loteprednol eye drops for the treatment of ocular inflammation and infection associated~     bacterial blepharitis and / or keratitis and / or conjunctivitis compared with the individual~     administration of azithromycin 1.5% and 0.5% Loteprednol (separately).~   "
141003|NCT01721681|"~     The primary objective of the study is to assess the efficacy of FACTOR X in the prevention of~     bleeding when given as routine prophylaxis over 12 months.~      The secondary objectives of the study are:~        1. To assess the pharmacokinetics of FACTOR X after a single dose of 50 IU/kg.~        2. To assess the safety of FACTOR X when given as routine prophylaxis over 6 months (26~          weeks).~   "
141004|NCT01721668|"~     Improving arm and hand function after stroke has been difficult to achieve within the~     rehabilitation service provided in the acute stage often due to the limited resource in~     health care. While spontaneous recovery plateaus after 6 months, the prolonged disability~     affects quality of life and social participation in stroke survivors. This study is aimed at~     improving chronic motor impairment arm and hand impairment by providing the intervention with~     intensive training schedule. This study will compare two types of rehabilitation intervention~     using a randomized controlled trial. Measurements also will be taken on various brain~     functions non-invasively to help discover how each of the intervention strategies works~     differently to repair the brain.~   "
141005|NCT01721655|"~     Bronchopulmonary dysplasia (BPD), also known as chronic lung disease (CLD), is a major~     complication of premature birth and is associated with a significant increased risk of~     complications including death. Diuretics have been used for decades in babies with BPD and~     are considered a standard of care. Patients receive electrolyte supplementation to replace~     the electrolytes removed by the diuretics. Spironolactone is not as good as other diuretics~     at removing extra fluid, but it is different from chlorothiazide and furosemide because~     instead of removing potassium, it actually can increase potassium levels in our body.~     Spironolactone is used with chlorothiazide to try to minimize the potassium lost; therefore,~     reduce the electrolyte supplementation needed. However, studies have suggested that preterm~     babies aren´t developed enough to appropriately respond to spironolactone. Also, one study~     has shown that adding spironolactone to chlorothiazide in patients with BPD has no effect on~     whether or not patients receive electrolyte supplementation. This study will examine whether~     there is a difference in the amount of electrolyte supplementation between patients receiving~     chlorothiazide only or chlorothiazide plus spironolactone. the investigators hypothesize~     there will be no difference in the amount of electrolyte supplementation between the two~     groups.~   "
141006|NCT01721642|"~     A pilot study to evaluate the safety and efficacy of the Apica Access, Stabilization, and~     Closure Device for accessing and closing the left ventricular apex during and after~     Transcatheter Aortic Valve Implantation (TAVI) procedures. Follow-up assessment will be made~     post-procedure, at 30 days and 90 days as well as longer term follow-up.~   "
141007|NCT01721629|"~     The aim of this study is to investigate two different strategies for the withdrawal of CPAP~     in preterm infants born before 32 weeks of gestation.~   "
141008|NCT01721616|"~     Despite the generalized use of preoperative antibiotic prophylaxis, endometritis remains as~     the most frequent post-cesarean delivery complication. This increased morbidity translates~     into extended post-partum antibiotic use and prolongation of hospital stay with the~     subsequent increase in health care expenses. The current regimen recommended by the American~     College of Obstetricians and Gynecologists for cesarean delivery prophylaxis (1st generation~     cephalosporins) does not cover for Ureaplasma Urealyticum, a microorganism that has been~     associated with an increased risk of endometritis in post-cesarean section patients.~     Azithromycin, an antibiotic that has both aerobic and some anaerobic coverage, uniquely~     covers Ureaplasma and would be an excellent second antibiotic for cesarean section~     chemoprophylaxis. Our hypothesis is that the addition of azithromycin to standard~     chemoprophylaxis with cefazolin can effect a 25% reduction of post-cesarean section~     endometritis.~   "
141009|NCT01721603|"~     The purpose of this study is to test the safety and find out what effects, good and/or bad,~     dabrafenib (a BRAF inhibitor) alone or dabrafenib when given in combination with gamma knife~     radiosurgery has on participants with a certain type of skin cancer (BRAFV600E melanoma) and~     brain metastases (tumors that have spread to the brain).~   "
141010|NCT01721590|"~     Tongxinluo is a kind of Chinese patent drug,which could promote blood circulation.Recent~     reports suggested that tongxinluo's effectiveness in reducing the thrombin activity.In this~     prospective randomized study,all patients in control group will receive blank placebo ,all~     patients in test group will receive tongxinluo.All patients will be followed up for one year.~   "
141011|NCT01721577|"~     This is a single-center, open-label, non-randomized, Phase I/IIa study to investigate the~     safety, tolerability, and antitumor efficacy of AXL1717 (picropodophyllin as active agent~     formulated in an oral suspension; PPP) in patients with recurrent malignant astrocytomas~     (glioblastoma, gliosarcoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic~     oligoastrocytoma, and anaplastic ependymoma). Patients will be treated for up to 5 cycles. A~     treatment cycle is defined as 28 days+7 days rest (28+7 days during cycle 1 to 4, and 28 days~     during cycle 5). The following cycle will not be started until the treatment continuation~     criteria are fulfilled. Concomitant supportive therapies will be allowed.~   "
141012|NCT01721564|"~     6 months therapy of Bosentan, an endothelin antagonist, will lead to improvement in pulmonary~     microvascular endothelial function.~   "
141013|NCT01721551|"~     The purpose of the current study is to investigate whether changes in patients' sleep quality~     and quantity will be followed by improvements in parameters related to physical and mental~     fatigue in patients receiving hemodialysis therapy.~      More specific, the current project will investigate the effect of a 9 months intradialytic~     exercise training in aspects related to fatigue, quality of life and depression.~   "
141014|NCT01721538|"~     SCENARIO is a trial to investigate the role of non-drug weight reduction in secondary~     prevention of stroke. It is a single-blinded, randomized, controlled multicentre trial with~     two arms. The therapy arm is participating in a comprehensive weight reducing program,~     whereas the control group takes part in a lecture on healthy nutrition. The primary study~     objective is to assess the efficacy of non-drug therapeutic weight reduction in the secondary~     prevention of stroke. Secondary objectives are functional outcome, cognitive status, post~     stroke depression, and health-related quality of life.~   "
141015|NCT01721525|"~     This study seeks to develop a new induction chemotherapy regimen which is a combination of~     two pill drugs taken by mouth and two drugs given by vein. This is a phase I study, which~     means that the primary goal is to establish the recommended dose of an investigational drug~     when added to chemotherapy. The researchers wish to evaluate the effects, good and bad, of~     the investigational drug.~   "
141016|NCT01721512|"~     Prospective cohort study of breast and formula fed infants in a suburban setting in Jakarta,~     Indonesia~   "
141017|NCT01721499|"~     This is a study of treatment approaches aimed to improve self-control and decrease stress and~     unhealthy/maladaptive behaviors such as drinking, overeating, and smoking.~      High levels of stress may make it harder to maintain self-control, especially when trying to~     control our unhealthy behaviors. Training on improving self control and decreasing stress may~     help decrease unhealthy behaviors. The goal of this new training program will be to decrease~     a subject's unhealthy behavior by helping them better manage their stress and improve their~     self control over unhealthy habits.~   "
141018|NCT01721486|"~     The purpose of this study is to compare IV acetaminophen to oral acetaminophen for pain~     control in children undergoing tonsillectomy with or without adenoidectomy.~   "
141019|NCT01721473|"~     Cigarette smoking is more prevalent among Veterans (27%) than the general U.S. population~     (21%). Smoking is common among people who use marijuana or caffeine heavily, and the use of~     menthol cigarettes is becoming increasingly common, affecting approximately 9% of the Veteran~     population. Recent research by the group and others indicates that heavy marijuana or~     caffeine use, or the use of predominantly menthol cigarettes, can alter brain nicotinic~     acetylcholine receptor (nAChR) densities. For the proposed study, brain imaging with PET~     scanning will be used to determine nicotine receptor densities in Veteran cigarette smokers~     with and without heavy marijuana or caffeine use, and in menthol and non-menthol Veteran~     smokers. Results of the proposed research may have implications for improving treatments for~     Veterans who smoke cigarettes and who have specific drug use co-morbidities or who use~     menthol cigarettes.~   "
141020|NCT01721460|"~     The purpose of this research study is to find out whether dexmedetomidine changes brain cell~     activity in the subthalamic nucleus (STN).~   "
141021|NCT01721447|"~     The investigators intend to determine if using Optison echocardiography contrast increases~     sensitivity and specificity of detecting left atrial appendage thrombus in transesophageal~     echocardiography studies as opposed to standard 2D and 3D TEE imaging without the use of echo~     contrast.~   "
141022|NCT01721434|"~     Levosimendan is a relatively new drug that improves cardiac contractility in patients with~     heart failure. Its main mechanism of action is enhanced binding of calcium to the myocardial~     contractile proteins. Recent data from our lab showed that levosimendan improves~     contractility of human diaphragm in vitro (muscle fibers from COPD patient diaphragm) and in~     vivo (healthy subjects). Accordingly, levosimendan may appear of value in the treatment of~     disorders associated with impaired respiratory muscle function, such as mechanically~     ventilated patients.We hypothesize that levosimendan could improve respiratory muscle~     function in mechanically ventilated patients commencing a CPAP trial.~   "
141023|NCT01721421|"~     Design: Prospective randomised cross-over study. Fifty-two eligible patients will be~     randomised to a treatment time of either 6 hours or 4 hours for a period of 24 weeks and~     following a washout period of 4 weeks, switch to the alternative treatment time for an~     additional 24 weeks.~      Aims: To examine the feasibility and effect of extended dialysis treatment time, 6 hours~     thrice weekly, versus the standard, 4 hours thrice weekly, comparing the differences from~     baseline in outcome measures over a total 12-month period.~      Primary outcome measure~      1]Serum albumin~      Secondary outcome measures Nutritional status~        1. Malnutrition-inflammation score~        2. Dietary intake~        3. Hand-Grip strength~        4. Energy expenditure~      Quality of life~        1. Patient reported quality of life and~        2. time to recovery from dialysis~      Serum biomarkers~        1. BNP~        2. Troponin~        3. MCP-1~      Others 24- hour Ambulatory blood pressure 24-hour accelerometer~      Population: Local haemodialysis population of 1200 patients Eligibility: Minimum 90days on~     haemodialysis treatment Duration: Fifty-six weeks~   "
141024|NCT01721408|"~     This is a comparative study of the efficacy and safety of tigecycline to imipenem/cilastatin~     in hospitalized patients with a complicated intra-abdominal infection.~   "
141160|NCT01719614|"~     The purpose of the study is to evaluate the effect of steady-state (constant concentration of~     medication in the blood) rilpivirine on pharmacokinetics (how a single dose of metformin is~     absorbed in the body, distributed within the body, and removed from the body) of a single~     dose of metformin, over time, in healthy adult participants.~   "
141025|NCT01721395|"~     Cough is a frequent symptom in children and infants and is one of the most common reasons~     parents visit a healthcare provider for their child. The US Food and Drug Administration has~     issued a warning that over-the-counter cough and cold medicines including antihistamines,~     decongestants, anti-tussives, and expectorants should not be administered to children younger~     than 2 years of age due not only to lack of proven efficacy, but also because of important~     safety concerns. Honey, another method of soothing cough cannot be used in children <1 year~     due to concerns for infantile botulism. A preparation from agave syrup has been created to~     address the need for an infant cough syrup. Although no studies have formally evaluated the~     use of agave nectar for nocturnal cough associated with Upper Respiratory Infections, the~     demulcent effect and sweet taste of agave nectar may provide some relief from cough in~     children.~   "
141026|NCT01721382|"~     This pilot study will be conducted in adolescents with cystic fibrosis (CF) without diabetes~     but with abnormal glucose tolerance, and will assess the effects of sitagliptin on glucose~     regulation. An oral glucose tolerance test (OGTT) and a mixed meal tolerance test (MMTT),~     will be performed at baseline and again ~4 weeks after treatment with study drug. We will~     also look at blood sugars throughout the day using a continuous glucose monitor (CGM) before~     each time the MMTT/OGTT are performed. Several hormones that may affect the way the body~     regulates blood sugars will be measured in blood when the OGTT and MMTT are done. We will~     assess the effect this medicine has on blood sugars (using CGM) and the effect the medicine~     has on the hormones measured during the OGTT and MMTT.~   "
141027|NCT01721369|"~     The SYNCAT study intention is to study the level of adherence of the centers in Cataluña tu~     the Syncope Guidelines ESC2009 for the diagnosis and treatment of syncope and the impact that~     following them can have in the prognosis of these patients.~   "
141028|NCT01721356|"~     Emotional Intelligence (EI) is defined as the ability to accurately perceive and identify~     emotions in oneself and others, understand and use emotions to enhance cognitive processes,~     and effectively manage one's own emotions as well as those of others. Two major approaches to~     the construct of emotional intelligence have emerged. These two approaches can be broadly~     defined as the Trait and Ability Approaches. The Trait Approach, which is typically assessed~     via self-report measures such as that Bar-On Emotional Quotient Inventory, appears to be~     strongly related to existing models of personality and coping. The other major approach to EI~     follows an Ability Model, assuming that EI is similar to but distinct from other types of~     cognitive intelligence, and involves measurement of a variety of skills and abilities related~     to emotional processing. An understanding of the neurobiological substrate of emotional~     intelligence is beginning to emerge. One influential theory that is particularly relevant to~     the neurobiology of emotional intelligence is the somatic marker hypothesis, yet there~     still remains a limited understanding of the neurobiological basis of EI. The proposed~     investigation will attempt to provide the most comprehensive study to date examining the~     behavioral, psychological, functional, and brain structural correlates of EI. The proposed~     study will use neuroimaging techniques to examine the relationship between current measures~     of EI, behavioral expression of emotionally competent capacities, brain functional responses,~     and structural cerebral organization.~      The specific questions to be addressed and their associated hypotheses are:~        1. The two major approaches to EI (i.e., Trait vs. Ability) will show only modest, though~          significant positive correlations with one another.~        2. EI Trait measures will be highly correlated with measures of personality but weakly~          correlated with specific skills such as facial affect identification, emotional~          decision-making, and affectively based judgments, whereas EI Ability measures will~          correlate more highly with specific emotional skill measures.~        3. During functional MRI affective challenge tasks, EI scores will be negatively correlated~          with activity within the Somatic Marker Circuitry suggested by Damasio and colleagues~          (i.e., ventromedial prefrontal cortex, amygdala, insular cortex), as suggested by the~          neural efficiency hypothesis.~   "
141029|NCT01721343|"~     This randomized clinical trial studies collaborative targeted case management in improving~     functional status in patients with stage III-IV cancer. Collaborative targeted case~     management may improve functional status and preserve performance in patients with advanced~     cancer~   "
141030|NCT01721330|"~     The primary aim of this study is to assess whether naltrexone as a monotherapy is effective~     in treating ADHD in adults. Medications that increase dopamine are often effective treatments~     for ADHD. Since naltrexone is a kappa opioid receptor antagonist, it increases dopamine in~     the brain. The investigators predict that naltrexone as a monotherapy will be effective for~     ADHD symptoms in adults with ADHD.~      The investigators also plan to assess the effects of naltrexone on dopamine as measured by~     changes in serum prolactin. The investigators predict that naltrexone will increase dopamine~     as indexed by decreases in serum prolactin. This study will be a six-week, double-blind,~     placebo-controlled pilot study with adults 18-55 years of age with ADHD.~   "
141031|NCT01721317|"~     This is a Phase IV adjunctive treatment dose-optimization study evaluating the efficacy,~     safety, and health outcomes of ezogabine/retigabine immediate release (IR) (GW582892)~     compared with placebo in adult subjects with partial-onset seizures (POS). This randomized,~     double-blind, placebo-controlled, parallel-group, multicenter study will compare~     ezogabine/retigabine IR (investigator-selected daily doses of 600 milligram (mg)/day, 750~     mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day) with placebo. Study drug will be taken three~     times a day (TID) in equally or unequally divided doses.~      The study design includes up to a 10-week (wk) Screening (≤2 wks)/Baseline (8 wks) Phase, a~     Titration Phase (2 wks), Dose-Optimization Phase (8 wks), Maintenance Phase (8 wks), and~     Taper/Follow-Up Phase (3 wks). The total duration of the study for each subject will be~     approximately 31 wks, and at minimum approximately 27 wks if subjects provide reliable 28-day~     retrospective seizure data.~      Approximately 280 subjects will be screened with approximately 208 subjects randomly assigned~     to 1 of 2 treatment groups in a 2:1 ratio (ezogabine/retigabine IR, or placebo).~      Subjects will be instructed to start investigational product (IP) the day after the baseline~     visit. During the first week of the Titration Phase, subjects will be taking 300 mg/day (100~     mg TID). During the second week, subjects will be taking 450 mg/day (150 mg/day TID).~      At the beginning of the Dose-Optimization Phase (3rd week of study drug) subjects will take~     600 mg/day (200 mg TID) for one week. Thereafter during the Dose-Optimization Phase, subjects~     will continue to increase their daily dose by 150 mg per week until they have achieved their~     optimal tolerated dose. During this phase, the investigator may choose to have the subject~     stay on his/her designated dose for another week before attempting a dose increase until~     reaching a dose of 1200 mg/day. In addition, in the context of tolerability issues, the~     subject may be reduced to the preceding dose level for one week before attempting to increase~     the dose again at the next scheduled time point until the subject reaches optimal dose.~     Subjects unable to tolerate a minimum of 600 mg/day will be discontinued from the study.~      The Maintenance Phase will begin at Week 10 (Visit 8) and will last 8 weeks. During the~     Maintenance Phase, subjects will remain on the daily TID dose achieved at the end of the~     Dose-Optimization Phase.~      Seizure type and frequency will be monitored throughout the study via a Seizure Calendar and~     will be evaluated at each study visit. Subjects will be instructed to complete the daily~     Seizure Calendar during each phase of the study.~   "
141032|NCT01721304|"~     The purpose of this study is to determine if using a computer survey about preferences for~     treatment of abnormal uterine bleeding (AUB) is useful and if it will improve patient~     satisfaction with clinical care and decision making. This study is a two-part study. The~     first pilot tests the computerized tool to ensure it is understood by patients, then the~     second part is a randomized study (computerized tool versus usual care) to see if~     improvements are made in satisfaction and if there are reductions in decision regret.~   "
141084|NCT01720615|"~     The objective of the present investigation is to analyze EEG and auditory evoked potentials~     at the transition from consciousness to unconsciousness and vice versa. A set of~     electroencephalographic and auditory evoked potential parameters should be identified that~     allows separation of consciousness from unconsciousness (reflected by~     responsiveness/unresponsiveness to command). The study is based on data of 80 patients~     undergoing general anesthesia with remifentanil and either sevoflurane or propofol.~   "
141033|NCT01721291|"~     Patients with chronic obstructive pulmonary disease (COPD) experience breathing difficulties~     because the airways deep in their lungs become narrowed. COPD patients use inhaler drugs to~     provide relief from breathlessness. However, current inhalers are inefficient as they deliver~     a 'coarse-mist' of drug-droplets that do not reach the deep airways.~      In our study, we will use an inhaler of 'fine-mist' drug-droplets, tagged with a radioactive~     tracer to track them. We will take images of the lungs to see if the fine-mist droplets reach~     the deep airways, and assess if this improves the breathing capacity in our patients. Our~     research may allow the development of new, more efficient inhalers to improve treatment for~     patients with COPD.~   "
141034|NCT01721278|"~     Total hip replacement (THR) is a highly effective procedure in relieving pain and restoring~     function. Many different implants can be used in artificial hip joints. Hydroxyapatiteceramic~     (HAC) coating has become a well established The JRI Furlong® HAC femoral stem is one such~     implant with good long term survivorship. The femoral implant has been used since 1985 and~     published findings have shown a 97.4% survivorship at a mean of 17 years follow up in~     patients. The Furlong Evolution® design is based on the tried and tested Furlong HAC but with~     some modifications.~      This is a 10 year multicentre clinical surveillance study, which aims to assess the clinical,~     functional and radiological performance of the Furlong Evolution® Hip stem in human patients.~   "
141035|NCT01721265|"~     All subjects in this study have previously been in an Idenix HCV study and received study~     drug for 3 consecutive days. Subjects who had received placebo in a previous Idenix study~     will not be enrolled in this study.~      In this study, researchers will try to find answers to these questions:~        -  How much (if any) hepatitis C virus is in your blood after stopping your Idenix study~          drug?~        -  Is your hepatitis C virus possibly resistant to treatment with the Idenix study drug or~          similar drugs?~   "
141036|NCT01721252|"~     The aim of this study is to determine prospectively the value of a recently identified~     proteomic signature in identifying those patients with lung cancer, who are likely to benefit~     from and respond favourably to erlotinib therapy.~      This is a prospective study of serum proteomics as a predictor of response to erlotinib~     therapy.~   "
141037|NCT01721239|"~     In 2010 alone were admitted 33,361 patients for treatment in Danish intensive care units.~     There is evidence to former intensive care patients have a significant symptom burden that~     affect recovery, function and activity for up to several years after admission to the~     intensive care unit. For the individual patient involves the low quality of life, delayed~     recovery, prolonged illness and healing process, and increased mortality. It requires that~     health professionals should provide support so patients quicker return to their usual life.~     Follow-up interviews with the staff after hospitalization in ICU have been shown to support~     the patient and identify individual needs and symptoms that can lead to more realistic~     expectations and increased well-being after admission in ICU. Follow-up in Denmark is being~     inconsistent in both the number of hospitals that offer this service, and in the offered type~     of service. Follow-up interviews with and without diaries suggest to improve physical and~     mental well-being and health, with limited scientific evidence of the efficacy of these~     interventions. We will investigate the effect of a standardized follow-up program after~     admission to the intensive care unit, consisting of written information, patient photos taken~     during hospitalization and three follow-up calls compared with standard care (discharge~     without follow-up).~      During a clinical study conducted in several intensive care units in Denmark examined whether~     follow-up calls can improve patients' well-being and health, as well as the meaning of the~     follow-up program has on the patient's everyday life in the first year after hospitalization~     in the ICU.~      The investigation contribute knowledge to the international research by revealing symptom~     burden and efficacy of a follow-up program for up to 1 year after admission to the ICU in~     order to be able to target rehabilitation efforts and improved the quality of life. It will~     be innovative to use the results from a clinical study as a foundation for a database, and~     the method can serve as a precedent for evidence-based introduction of guidelines, database~     registration and create the groundwork for future research in intensive care. This study is~     expected to be profitable to society by preventing frequent readmissions, reduce medication~     costs and fewer referrals to specialists and have a positive effect on retention to the labor~     market. This will provide overall better use of society's expenses.~   "
141038|NCT01721226|"~     The purpose of this study is to determine whether an intervention (CARE+ Corrections)~     delivered to HIV-infected detainees within the DC Department of Corrections (DOC) and~     recently -released ex-detainees in the community can improve linkage to community HIV care~     and adherence to HIV medications after release, and ultimately achieve or maintain HIV viral~     suppression following community re-entry.~   "
141039|NCT01721213|"~     As part of a European post-marketing commitment, GSK will conduct a survey of physicians' and~     patients' understanding of the significant risks associated with Trobalt™ (retigabine), as~     described in the Patient Information Leaflet (PIL) and the Physician's Guide. The goal of the~     surveys is to evaluate the effectiveness of the educational plan as specified in the European~     Risk Management Plan (RMP).~      The objectives of this study are to assess patients' and prescribers' understanding and~     knowledge of the significant risks associated with Trobalt™ use as evaluated by a survey~     instrument.~      This is a cross sectional survey of:~        1. 250 patients recruited from across the following countries (United Kingdom, Sweden,~          Denmark, Switzerland, Spain, Slovakia and Norway) and up to 100 patients from Germany~          who are currently using or have filled a prescription for Trobalt™ at least once in the~          last 3 months.~        2. 200 neurologists who have prescribed an anti-epileptic drug (AED) at least once in the~          last 3 months, and who were on the list to which a letter containing the Physician's~          Guide for Trobalt™ was distributed from across the following countries (United Kingdom,~          Sweden, Denmark, Switzerland, Spain, Slovakia and Norway). At least 75 of the~          neurologists will have prescribed Trobalt™. The survey will also aim to include up to~          100 neurologists from Germany of which approximately 50 will have prescribed Trobalt™.~      Patients eligible for the survey will be asked to take the survey online or via a telephone~     interview if the latter is preferred. Neurologists will be invited to take the survey online.~      The selected countries were the first five countries to launch Trobalt™ (Germany, Denmark,~     United Kingdom, Switzerland and Sweden) and an additional three countries with launch in~     2011, but with relatively high rates of uptake of Trobalt™ (Spain, Slovakia and Norway). The~     selection of countries includes Switzerland, which is not part of the European Union.~     However, the key messages regarding the risks with Trobalt™ are in alignment. The rationale~     for surveying the first five countries to launch is so that any issues identified from these~     countries regarding the effectiveness of the Physician's Guide and PIL in communicating the~     risks of Trobalt™ can be addressed as soon as possible, and the key messages can be revised~     in a timely manner. In addition, these countries are likely to provide the greatest number of~     neurologists with experience of prescribing Trobalt™, and their patients.~      The primary outcome of the survey is the proportion of patients/neurologists providing~     correct responses to a series of questions concerning the significant risks associated with~     Trobalt™. The risks evaluated will be those described in the Trobalt™ PIL and in the~     Physician's Guide.~   "
141040|NCT01721200|"~     This study is a randomized controlled trial designed to examine the efficacy of an~     educational decision support tool for patients with rheumatoid arthritis who continue to have~     active disease despite use of traditional disease modifying drugs. The study will take place~     at Geisinger Medical Center in Danville, PA. Eligible subjects will be identified by the~     treating physician and those providing consent will be randomized to usual care versus use of~     the decision support tool.~   "
141041|NCT01721187|"~     Using fMRI, this study will explore the neural correlates of satiety when individuals make~     decisions about food. The investigators will also examine individual differences in satiety~     effects.~   "
141085|NCT01720602|"~     This pilot clinical trial studies vorinostat in treating patients with stage IV breast cancer~     receiving hormone therapy. Vorinostat may help hormone therapy work better by making tumor~     cells more sensitive to the drug.~   "
141086|NCT01720589|"~     The purpose of this study is to test the effects of a cooking oil blend of dietary fats rich~     in medium chain triglycerides on energy expenditure and food intake in overweight and obese~     children.~   "
141087|NCT01720576|"~     This is a study to assess the safety and tolerability of subcutaneously administered REGN1033~     (SAR391786) in healthy volunteers.~   "
141042|NCT01721174|"~     Malignant bile duct obstruction is a common sequela of pancreatic cancers or distal bile duct~     cancers, and its development can hinder the use of chemotherapy, decrease patient quality of~     life, and decrease survival. To relieve obstructive jaundice as a result of the obstruction,~     endoscopic stent placement is usually required. The use self-expandable metal stents (SEMSs)~     have been shown to result in a longer patency times as compared with plastic stents. However,~     despite improvements in materials and stent design, stent obstruction still occurs in 13% to~     44% of the patients. Tumor in-growth is the most common mechanism of stent obstruction.~      Recently, the use of endoscopic biliary radiofrequency ablation (EBRFA) have been described~     in patients suffering from inoperable malignant distal common bile duct (CBD) obstruction.~     The procedure uses heat energy to cause local tumour tissue death, resulting in re-opening of~     the bile duct lumen. The procedure has the potential of reducing the rate of stent~     obstruction after SEMS and also prolonging survival. The safety profile appears to be~     comparable that of placement of SEMS alone without added complications (<10%). The aim of the~     current study is to compare the efficacy of EBRFA with the addition of SEMS to SEMS alone in~     a randomized controlled trial.We hypothesize that the application of EBRFA can reduce~     recurrent biliary obstruction after SEMS.~   "
141043|NCT01721161|"~     The primary objective of the study is to evaluate the efficacy of BIIB033 in subjects with~     their first episode of unilateral acute optic neuritis (AON). The secondary objective of this~     study is to assess the safety, tolerability, and pharmacokinetics (PK) of BIIB033 in this~     study population.~   "
141044|NCT01721148|"~     There is a great need for new therapies for carcinomas that have progressed on or not~     responded to current therapy. There are no approved Met targeted agents in standard clinical~     use. In the population of subjects with advanced carcinomas that are unresponsive to standard~     of care, and based on the relatively safe, reversible and monitorable toxicity profile of~     ASLAN002 in non clinical studies, the potential for benefit from ASLAN002 outweighs the~     potential risks for toxicity.~      The purpose of this study is to identify the maximum tolerated dose of ASLAN002 in subjects~     with advanced or metastatic solid tumours, as well as to define the overall safety profile of~     ASLAN002.~   "
141045|NCT01721135|"~     This study is a randomized, placebo controlled, four way crossover, in which the the effect~     of GSK2190915 on the QTc interval is assessed. Healthy subjects will recieve a 5 day course~     of each of the following; oral placebo, GSK2190915 100mg, GSK2190915 1000mg and moxifloxacin~     400mg (single dose) with a weeks washout prior to starting the next course. Key assessments~     include a 12- lead electrocardiogram and pharmacokinetic testing. Safety will be assessed by~     blood pressure, heart rate, clinical laboratory safety tests and collection of adverse events~     .~   "
141046|NCT01721109|"~     This study is to evaluate the steady-state pharmacokinetics (PK) and confirm the dose of the~     elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF) single~     tablet regimen (STR) in HIV-1 infected, antiretroviral (ARV) treatment-naive adolescents.~     Safety, tolerability, and efficacy will also be evaluated through Week 48.~      A total of 50 adolescent participants (12 to < 18 years of age) will be enrolled to receive~     EVG/COBI/FTC/TDF as follows:~        -  Part A: Twelve to 16 eligible participants will be enrolled to evaluate steady-state PK,~          and confirm the dose, with the intent to enroll at least 4 participants 12 to < 15 and~          at least 4 participants 15 to < 18 years of age.~        -  Part B: Following confirmation of EVG exposure in at least 12 participants from Part A,~          34 to 38 participants in addition to those enrolled in Part A will be enrolled to~          evaluate the safety, tolerability and antiviral activity of EVG/COBI/FTC/TDF STR.~   "
141047|NCT01721096|"~     The objectives of the PMS are to observe the frequency, type, and degree of device deficiency~     to assure the safety of the new medical device (XIENCE PRIME) as well as to collect~     information on evaluation of the efficacy and safety for reevaluation.~   "
141048|NCT01721083|"~     This study is designed to compare two different styles of intramuscular injection (Bunch~     versus Z-Track)during flu vaccination with the following outcome measures as basis for~     comparison: perceive pain, redness, medication leakage, other complications within 72 hours~     in healthy adult volunteer subjects.~   "
141049|NCT01721070|"~     Evaluate the effect of taking ketoconazole on sufentanil plasma concentrations following~     sublingual administration of sufentanil NanoTab.~   "
141050|NCT01721057|"~     The purpose of this study is to determine whether baricitinib 4 milligram (mg) once daily~     (QD) is superior to placebo in the treatment of participants with moderately to severely~     active Rheumatoid Arthritis (RA) who have had inadequate response to or are intolerant to at~     least 1 conventional disease-modifying antirheumatic drug (cDMARD)(cDMARD-IR [inadequate~     response] participants) and who have not received a biologic disease-modifying antirheumatic~     drug (DMARD).~   "
141051|NCT01721044|"~     The purpose of this study is to determine whether baricitinib 4 milligram (mg) once daily is~     superior to placebo in the treatment of participants with moderately to severely active~     Rheumatoid Arthritis (RA) who have had an inadequate response to a tumor necrosis factor~     (TNF) inhibitor, despite ongoing treatment with conventional disease-modifying antirheumatic~     drugs (cDMARDs).~   "
141052|NCT01721031|"~     Catheter-related bladder discomfort (CRBD) secondary to an indwelling urinary catheter is~     defined as an urge to void or discomfort in the supra-pubic region. This symptom complex may~     cause patient agitated and exacerbated postoperative pain. In clinic, dorsal penile nerve~     block (DPNB) was applied for penile surgery including circumcision and some anterior urethra~     surgery. The investigators hypothesize that DPNB relive CRBD for male patients with~     indwelling urinary catheter under general anesthesia.~   "
141053|NCT01721018|"~     HSV1716, an oncolytic virus, is a mutant herpes simplex virus (HSV) type I, deleted in the~     RL1 gene which encodes the protein ICP34.5.~      Malignant mesothelioma is an aggressive, asbestos-related tumour of the pleural and~     peritoneal cavities. It is a rare cancer which occurs in individuals who have been exposed to~     asbestos, although it typically occurs decades after exposure (10-40 years later). Malignant~     pleural mesothelioma forms plaques that are distributed on the surface of the pleural space~     in the lung. Approximately 30% of patients require an indwelling pleural catheter for~     drainage of pleural effusions. In this patient group, the indwelling catheter may be used to~     facilitate loco-regional delivery of HSV1716 to the pleural space.~      This study seeks to evaluate the safety and biological effects of single and multiple~     administrations of HSV1716 in the treatment of malignant pleural mesothelioma.~   "
141054|NCT01721005|"~     The aim of this study is to evaluate the feasibility of patient education on feeling the own~     pulse irregularity in the elderly population of Lieto.~      Prevalence of atrial fibrillation (AF) rises with age. Subjects have often symptoms like~     palpitation and discomfort but especially in elderly population there's significant quantity~     of persons who don't feel any symptoms and fail to seek for medical care for stroke~     prevention.~      The main objectives in this study are to find out the prevalence of AF in the elderly~     population of Lieto, to assess the feasibility and reability of patient education on feeling~     one's pulse irregularity and the affect to the quality of life of the participating subjects~     and monitoring the possible increased burden to the public health care system.~      The study contains two office visits with specified learning session and long-term phone-call~     follow-up.~   "
141055|NCT01720992|"~     Background: Shamshuipo District has the highest proportion of low income families, and a~     relatively large percentage of single parents, elderly, new immigrants among all districts in~     Hong Kong (Census and Statistics Department, 2011). In addition to provide these families~     substantial support, a campaign to enhance their family well-being is needed.~      Aim: This project is conducted to enhance their family relationship as well as family~     happiness, health and harmony (3Hs) among families in the Shamshuipo District, through a~     community-based intervention programme combined with a planning tool (booklet).~      Methods: This project adopts a cluster-randomized controlled design, with the application of~     positive psychology concepts as a theoretical framework. A community-based participatory~     (CBP) approach, which is an effective way to engage public health researchers and community~     members (NGOs, other major stakeholders, and participants), will be used. Both quantitative~     and qualitative methods will be used in the evaluation of major outcomes (participants'~     family relationship and 3Hs) at different time points throughout the project. Process~     evaluation will be performed to evaluate the process of each component of the project.~      Procedure: This project will be conducted in three phases.~      Phase 1 includes planning, implementation, and evaluation of a training programme for social~     workers from the 30 participating NGOs. The social workers will be equipped with the~     knowledge and skills of the application of positive psychology as well as logic model. This~     phase also includes the launching event to arouse public awareness of the project.~      Phase 2 includes designing, delivering, and evaluating 30 community-based intervention~     programmes. A planning tool (designed as a booklet) will be distributed to participants of~     the intervention group in the form of 'homework assignment' immediate after the intervention~     programme; whereas participants of the control group will receive the booklet upon the~     completion of the three months follow-up questionnaire assessment. This phase also contains~     focus group interviews among participants to collect their experiences, feelings and changes~     in families after attending the intervention programme. Focus groups among social workers~     will be conducted afterwards to explore their barriers and facilitators in programme~     implementation; as well as their personal and/or collective growth in conducting the project.~     In-depth interview among community stakeholders will be held to explore the social impact of~     the CBPR project, and collect their suggestions for future implementation.~      Phase 3 is a dissimilation phase that the Positive Family Education Booklet and Positive~     Family Practice Manual will be released. A practice wisdom forum for social workers and~     other major stakeholders will also be organized to share their experiences in conducting the~     community-based programmes.~      Primary hypothesis: Families participated in a community-based programme and received a~     toolkit (intervention group) have higher scores in their family relationship and family 3Hs~     than families who participated in a community-based programme only (control group).~      Secondary hypotheses: (1) Participants' attitudes towards and intention of practising the~     suggested behaviours will be increased immediately after their participation in the~     community-based intervention programme; (2) Participants' attitudes towards, their intention,~     as well as frequency of practising the suggested behaviours will remain higher at 6 weeks and~     3 months after the intervention compared to the corresponding figures of pre-intervention~     (baseline); (3) Participants' scores of family relationship and 3Hs will be significantly~     higher at 6 weeks and 3 months after their participation in the intervention.~   "
141056|NCT01720979|"~     Traumatic Brain Injury (TBI) is the world leading cause of acquired brain injury. Literature~     suggests a pivotal role for attentional functioning in neurocognitive and behavioural~     consequences of paediatric TBI. Limitations of traditional neuropsychological measures of~     attentional functioning have interfered with identification of the effect of paediatric TBI~     on attentional networks so far. Moreover, the associations between attentional networks,~     learning abilities, academic performance and behavioural and emotional problems following~     paediatric TBI are yet to be explored.~   "
141057|NCT01720966|"~     Rationale: Adhesion formation is a frequent complication after abdominal surgery. Adhesion~     formation might be reduced by laparoscopic surgery, however sound evidence is lacking.~     Colorectal surgery would be a good clinical model to investigate adhesion formation between~     open and laparoscopic surgery because of the adhesion formation propensity of colorectal~     surgery. However, a randomized controlled study to provide direct evidence is unlikely~     because of large numbers of patients needed for such a trial and the difficulty to check for~     adhesion formation at second surgery. Therefore we investigate adhesion formation after~     laparoscopic and open colorectal surgery for malignancy at liver surgery for metastases.~      Objective: The aim of our study is to compare the incidence of adhesions after laparoscopic~     versus open surgery for colorectal malignancies during liver resection for colorectal~     metastases.~      Study design: The study is designed as a prospective observational cohort study.~      Study population: All consecutive, adult patients undergoing laparotomy or laparoscopy for~     intended liver resection or radio frequency ablation for liver metastases of a colorectal~     malignancy in whom inspection of the middle and lower abdomen is possible to map adhesions.~      Main study parameters/endpoints:~        -  Primary endpoint is incidence of adhesions to the ventral abdominal wall around the site~          of the original incision.~        -  Secondary endpoints are episodes of bowel obstruction between index surgery and liver~          surgery; total incidence of adhesions; extent of adhesions; Zühlke classification of~          adhesions; performance of adhesiolysis; duration of adhesiolysis; peroperative~          complications: enterotomy, seromuscular injury, inadvertent organ injury during~          adhesiolysis; postoperative complications: delayed diagnosed perforation, SAE's.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: This study is an observational study. The existence of adhesions will be~     assessed during laparotomy or laparoscopy for the treatment of liver metastases. The~     laparotomy is indicated for medical treatment and should not be enlarged solely for the~     assessment of adhesions nor will the operating time be influenced for this purpose.~      Adhesions and peroperative complications have to be scored by the operating surgeon during or~     directly after surgery. The postoperative complications have to be scored during the~     postoperative course by the doctors on the ward. These assessments do not interfere with the~     treatment of the patients.~   "
141058|NCT01720953|"~     Purpose:~      Borderline personality disorder (BPD) is a complex psychiatric disease of uncertain aetiology~     and pathogenesis. A key mechanism of disease susceptibility and treatment response could be~     epigenetic changes in DNA methylation patterns. However, no study has yet demonstrated that~     psychotherapy can exert its therapeutic effect through epigenetic mechanisms. The main aim of~     this study is to analyze the promoter methylation pattern of genes considered to be related~     to the development and psychopathology of BPD, in particular the brain-derived neurotrophic~     factor (BDNF) and glucocorticoid receptor genes, and the effects of mentalization based~     treatment (MBT) on changes. Associations to changes in BDNF serum levels and salivary~     cortisol levels, as well as key components of BPD aetiology and core treatment targets in~     MBT, will also be investigated. Should epigenetic mechanisms have importance for BPD~     pathology and effects of treatment, there is potential use of DNA methylation patterns as~     valid biomarker measures of diagnosis, prognosis, and treatment response.~      Hypothesis:~      The formation and maintenance of symptoms in BPD is mediated through neuropsychiatric~     mechanisms that can be affected through psychological treatment. Specifically, aberrant~     epigenetic regulation of neuropsychiatric genes related to behavioural control and affect~     regulation, as well as BDNF and cortisol levels, is ameliorated by therapeutic processes.~      Method:~      Fifty female patients diagnosed with BPD will undergo a year of intensive MBT that is~     designed to target domains of BPD pathology. The patients will be assessed at baseline and~     every 6 months over the treatment period. Matched healthy control subjects will be assessed~     at 6 month intervals to compare changes in DNA methylation, BDNF serum levels, salivary~     cortisol levels, and neuropsychological test performance. To link components of the~     neuropsychiatric mechanisms underlying the onset of illness, course, and response to~     treatment, patients will undergo assessment of clinical symptoms, comorbidity patterns and~     psychosocial impairment. Patients and control subjects will at baseline undergo assessment~     for childhood trauma, self-harm, suicidal behavior, early maladaptive schemas, and~     personality traits, and within the 1-year study period also undergo continuous assessment for~     changes in symptoms of dissociation, depression, and personality dysfunction.~   "
141059|NCT01720940|"~     This study is being carried out to find out whether there is reduction in vancomycin-induced~     kidney injury (nephrotoxicity) when vancomycin is given as intermittent versus continuous~     infusion.~      This study will recruit 220 subjects from 2 hospitals over a period of 3 years.~      Participants are invited if they have an infection that requires prolonged vancomycin therapy~     (> more than 10 days).~   "
141060|NCT01720927|"~     GABHS are common etiological agents for acute pharyngitis. However, local data is limited and~     large scale surveillance studies have not been done. This study aims to evaluate the disease~     burden in the community due to GABHS.~      In this study, patients presenting with signs of acute pharyngitis will be evaluated.~     Patients with fulfilling the inclusion criteria will be tested for Rapid Antigen Detection~     test (RADT)~   "
141061|NCT01720914|"~     In this prospective, multicenter observational study we assess the diagnostic validity of the~     following standard screening instruments for delirium regarding sedation, analgesia and~     ventilator status in critically ill patients:~        -  Confusion Assessment Method for the ICU (CAM-ICU)~        -  Intensive Care Delirium Screening Checklist (ICDSC)~        -  Nursing-Delirium-Screening-Scale (Nu-DESC)~      The definite delirium diagnosis (definite in terms of reference standard) is made according~     to the criteria of the Diagnostic and Statistical Manual of Mental Disorders 4th Edition,~     text revised (DSM-IV-TR) published by the American Psychiatric Association (APA) which is the~     Gold Standard to diagnose delirium.~      Primary research question: Does sedation, ventilator status and analgesia influence the~     sensitivity of delirium screening tools (DST)?~   "
141062|NCT01720901|"~     To evaluate the efficacy and safety of increased dose of icotinib in advanced NSCLC patients~     who progressed after gefitinib therapy.~   "
141100|NCT01720407|"~     Lentigo malignant (LM) is an intraepidermal melanocytic proliferation occurring on~     photoexposed skin. In our project, this term applies both to Dubreuilh's melanosis and to~     Dubreuilh's intraepidermal melanoma. It consequently excludes invasive melanoma. Although~     surgery is the treatment of choice, it remains without consensus on the margins (5 mm or 10~     mm) excision for a localized tumor on the face.~      Several studies have shown that imiquimod, activating local immunity by interferon~     production, induced LM or MLM regression and could also decrease the frequency of relapses.~      The principal aim of our project is to study the effect of imiquimod versus placebo in~     pre-operative neoadjuvant treatment aimed at reducing both surgical margins, as from the~     first surgical procedure, and the frequency of short and medium term recurrence of LM.~     Furthermore, the improvement in patient quality of life could also be significant.~   "
141063|NCT01720888|"~     Despite the recent advances in medical and surgical treatment, heart failure resulting from~     ischemic cardiomyopathy (ICM) remains the leading cause of cardiovascular mortality. Ischemic~     dilated cardiomyopathy(ICM) is defined as abnormally enlarged left ventricular (LV) cavity~     with documented poor LV function as a result of severe coronary artery disease (CAD). LV~     remodelling which is inevitable after an infarct has been postulated to contribute largely to~     the poor outcome of patients with ICM, therefore prevention of LV remodelling is the goal for~     the treatment in patients with severe CAD. Cell therapy represents a novel therapeutic~     strategy for treating cardiac diseases including severe CAD and heart failure. A type of stem~     cells known as mesenchymal stem cells(MSCs)can be isolated from bone marrow.This study aims~     to test the differentiation potential and therapeutic capacity of MSC from severe CAD~     patients after intracoronary implantation in an ischemic myocardial environment in Malaysian~     population.~   "
141064|NCT01720875|"~     Bortezomib is an established treatment in multiple myeloma; it is common practice in the UK~     to administer bortezomib with dexamethasone. This practice is based on data that supports~     improved response rates with this combination.~      Recent trial data indicates that the addition of vorinostat to bortezomib treatment overcomes~     treatment resistance to bortezomib. As such this current trial is designed to investigate the~     efficacy, safety and tolerability of combination treatment with vorinostat, bortezomib and~     dexamethasone in patients with relapsed and relapsed refractory myeloma.~      A comparison of this Phase II trial with the pivotal Phase III trial conducted by MSD (using~     the labelled bortezomib indication without dexamethasone) will address the impact of~     dexamethasone in regards to tolerability and additional efficacy in myeloma patients.~   "
141065|NCT01720862|"~     This research is being done to look at the association between migraine and obesity.~   "
141066|NCT01720849|"~     The aim of the study is to assess improvement in visual evoked potential, cognition, fatigue,~     micturation and walking impairment under 3 months of Fampyra treatment~   "
141067|NCT01720836|"~     All subjects will receive the vaccine subcutaneously every 3 weeks x 3 and then every 3~     months for 3 years. The rationale for using Poly-ICLC as an adjuvant are two ongoing trials~     at University of Pittsburgh Cancer Institute (UPCI) of the MUC1 100mer peptide vaccine - one~     as a therapeutic vaccine in subjects with metastatic castrate resistant prostate cancer and~     the other in subjects with advanced colonic adenomas at risk for developing colon cancer. The~     same formulation, MUC1 100mer peptide admixed with Poly-ICLC, is used in both trials. There~     has been no toxicity observed and the vaccine is highly immunogenic in early disease. In the~     proposed NSCLC trial the anti-MUC1 immune response will be thoroughly characterized.~   "
141068|NCT01720823|"~     It is often clinically impossible to differentiate children with an isolated snoring from~     those with OSA. The diagnosis of OSA is currently based on nocturnal, laboratory-based~     polysomnography. This expensive examination is poorly accessible due to appointments delays~     at hospital.~      Our study is designed to compare the characteristics of a home polysomnography versus~     standard polysomnography for the diagnosis of pediatric OSA.~   "
141069|NCT01720810|"~     This study evaluates cognitive impairment in subjects with Parkinson disease (PD) and similar~     neurological disorder through obtaining longitudinal clinical and neuropsychological data.~     The long term goal is to have a well-characterized subject population to contribute to our~     understanding of the natural history, diagnosis and ultimate treatment of cognitive~     impairment in patients with PD and similar disorders.~   "
141070|NCT01720797|"~     The purpose of this research study is to assess the clinical effectiveness of the procedure~     of a minimally invasive alveolar microperforation procedure to achieve accelerated tooth~     movement in patients undergoing orthodontic treatment. Accelerated tooth movement means~     that using the PROPEL™ device may help complete your treatment with braces on one side of~     your mouth sooner than would be expected if the device were not to be used.~   "
141071|NCT01720784|"~     Studies report that dietary fiber intake is inversely correlated with body weight gain.~     Previously, we have shown alginate fiber supplementation increases weight loss, which we~     ascribe to its satiating effct.Alginate is a major plant dietary fiber in brown seaweed. One~     property of importance to appetite is the ability of alginate to gel in the acidic~     environment of the stomach. We hypothesize that the alginate will decrease the feeling of~     hunger and lower food consumption compared to control.~      Here we test three different beverages in a double-blinded crossover design, in which 24~     participants will be randomly assigned to the sequence of the test days separated by at least~     5 days.~      On each test day appetite sensation as well as blood glucose and insulin will be measured~     over 4h after intake of the test product. Hereafter, an ad libitum meal consisting of Pasta~     Bolognese will be served, and energy intake calculated. The participants will also rate~     gastrointestinal confort.~   "
141072|NCT01720771|"~     The aim of the prospective project is to investigate effect of daily probiotic supplements on~     dental caries development in preschool children living in a low socioeconomic immigrant area~     in souithern Sweden. The study design is a randomised controlled trial with two parallell~     arms. The intervention is one probiotic tablet or placebo once daily. The null hypothesis is~     that the caries experience and increment will not differ betwwen the two groups.~   "
141073|NCT01720758|"~     The presence of a specific mutation in the gene known as B-RAF has been found in patients who~     have Hairy Cell Leukemia. In this study this specific mutation known as V600E will be~     ascertained in peripheral blood samples of patients who have this disease and in a group of~     patients who have a similar chronic lymphoproliferative conditions such as splenic marginal~     lymphoma. The finding of this specific mutation will help to verify or exclude the diagnosis~     of Hairy Cell Leukemia and determine whether patients are in remission.~   "
141101|NCT01720394|"~     The purpose of the study is to determine the efficacy of a silicone-double-balloon-catheter~     for cervical ripening and labor induction in women with unfavorable cervix (Bishop Score not~     greater than 6) compared to medical treatment using a dinoprostone~     slow-release-vaginal-insert.~   "
141102|NCT01720381|"~     The study is to demonstrate the accuracy of the OptiScanner in measuring blood glucose levels~     in critically ill patients when compared to a reference YSI 2300 STAT Plus and the Gem 3000,~     the reference standard for Erasme University Hospital.~   "
141161|NCT01719601|"~     The purpose of this study is to evaluate the safety and effectiveness of immediate release~     tapentadol hydrochloride for the relief of moderate to severe acute non-cancer pain among~     Filipino patients.~   "
141074|NCT01720745|"~     ROLE OF SUCTION IN EUS-FNA: Current suction technique involves suctioning the aspirate into~     the needle that has an air column. The needle is not flushed with any liquid prior to passing~     into the desired solid lesion. Suction is applied when the needle is within the lesion~     leading to aspiration of tissue into the needle. This is the standard technique and some have~     done with and without the stylet. There are some data that favor non use of a stylet.~      WET SCTION TECHNIQUE:~      Wet suction technique involves flushing the needle with 1-2 cc of saline to replace the~     column of air with saline. The needle is now passed into the desired lesion. Suction is~     applied at maximal strength and needle moved back and forth within the lesion to obtain as~     aspirate. Drops of saline can be seen moving into the suction syringe as the aspirate moves~     into the needle. Needle is now withdrawn and aspirate delivered on to a slide by using a~     stylet and or flushing air into the needle with a syringe.~      HYPOTHESIS The effect of suction for the purpose of aspirating cells and / or tissue during~     fine needle biopsy may be significantly improved by filling the column of the needle with a~     less compressible fluid. The volume of vacuum being pulled may be negatively impacted by the~     expansion of air within the needle. Replacing the air with sterile saline may thus improve~     the suction transferred to the needle tip by ensuring that the full volume of the vacuum~     syringe is transferred to the distal tip of the needle. This effect would be most pronounced~     in larger gauge needles which would have a larger internal volume. An additional benefit of~     filling the needle with saline prior to aspiration is the speed of the pressure transfer. The~     theory is that the air in the needle may absorb some of the force of the sudden application~     of vacuum. A column of saline in the needle may increase the velocity of the pressure~     transfer providing more tissue and less blood.~   "
141075|NCT01720732|"~     Evaluation of a short version of Narrative Exposure Therapy~   "
141076|NCT01720719|"~     The purpose of the study is to compare the impact of atorvastatin 20mg qd and Vitamin E 300mg~     qd therapy on liver fat content in patients with type 2 diabetes associated with high LDL-C~     and non-alcoholic fatty liver disease.~   "
141077|NCT01720706|"~     This is a clinical research study designed to determine the safety and efficacy of the~     application of a unique interstitial radio frequency thermal therapy for the treatment of~     large tumours in the kidney or liver. The novel device offers patients a more effective~     therapy than conventional RFA and for patients with large tumours fewer number of treatments~     and needle insertion sites. The clinical treatment volumes (or sites of focal tumours) will~     be determined by a combination of biopsy and contrast enhanced CT imaging.~      The study will assess if novel device can produce lesions in the liver or kidney in a~     controlled and predictable manner and with sufficient size to effectively manage disease~     progression in the organ. The extent of lesion size at a delivered power setting and~     treatment time will be measured with post-treatment CT or MRI and biopsy as measures of~     tissue response~   "
141078|NCT01720693|"~     Many patients who are candidates for nephron-sparing surgery, partial nephrectomy is now the~     standard treatment with a surgical, small, clinical T1 tumor (<7 cm). In many recent studies,~     partial nephrectomy provides equivalent oncologic, and superior functional, outcomes compared~     with the standard radical nephrectomy over the short and long term (2, 3). Partial~     nephrectomy techniques, whether open, laparoscopic or robotic, typically involve hilar~     clamping, which creates the desired bloodless operative field, allowing for more precise~     tumor excision and renal reconstruction. This hilar clamping eventually may lead to ischemic~     kidney injury which can compromise the functional outcomes of the remaining kidney.We are~     working now to develop a novel technique of Hypo-Perfusion by achieving partial renal~     arterial clamping, with the goal of completely eliminating surgical ischemia to the renal~     remnant.~   "
141079|NCT01720680|"~     -  Title: Open-label, prospective exploratory study to assess the effects of the AlphaCore®~          device on central and peripheral airway dimensions in patients with COPD.~        -  Indication: COPD patients~        -  Study Design: Open-label, prospective design~        -  Study Phase: II~        -  Test treatment duration: 1 day~        -  Test treatment: AlphaCore® device~        -  Dosage regimen: 1 session of stimulation during 90 seconds~        -  Patient number: up to 10 evaluable patients with COPD~        -  Patient age: ≥ 18 years~        -  Sex: male or female~        -  Primary objective: The evaluation of the effect of the AlphaCore® device on central and~          peripheral airway dimensions with Computational Fluid Dynamics (CFD).~        -  Secondary objectives: The assessment of the effect of the AlphaCore® device on lung~          function (spirometry, diffusion and resistance) and on patient reported outcomes~          (PRO`s).~   "
141080|NCT01720667|"~     A new anticonvulsant, levetiracetam will be studied to treat seizures in newborn infants.~     Current treatments for the brain damaging complication of neonatal seizures are~     unsatisfactory.~      Monitoring for seizure detection will be tested at five (5) US sites and one (1)~     international site using the internet.~   "
141081|NCT01720654|"~     Expedited Partner Therapy (EPT) has been shown to reduce rates of persistent or recurrent~     gonorrhea and chlamydia infection in heterosexual patients, but has not been evaluated for~     use among men who have sex with men (MSM). CDC guidelines support the use of EPT for partner~     management with heterosexual patients, but note the absence of evidence necessary to make an~     equivalent recommendation for the use of EPT with MSM. Randomized clinical trials to assess~     the impact of EPT on partner notification, treatment, and STI re-infection among MSM are~     critical to the development of evidence-based partner management guidelines.~      Recent data from urban Peru has identified prevalences of rectal and pharyngeal gonorrhea and~     chlamydia ranging from 5-20%. The elevated burden of disease among MSM in Peru suggests that~     frequent transmission of undiagnosed gonorrhea and chlamydia through MSM sexual networks may~     be a factor contributing to the persistently high incidence of HIV infection among MSM in the~     region. The investigators propose a pilot evaluation of the effect of EPT on partner~     notification and treatment among MSM in Peru diagnosed with gonorrhea or chlamydia at any~     anatomic site.~      Specific Aim 1: To explore the social norms and structural factors influencing partner~     notification and treatment among MSM in Peru.~      Specific Aim 2: To determine the effect of EPT on anticipated and actual partner notification~     among MSM diagnosed with gonorrhea or chlamydia infection.~      Specific Aim 3: To develop preliminary data on rates of gonococcal and chlamydial~     re-infection among MSM randomized to receive EPT compared with standard partner notification~     counseling.~      The proposed study will provide pilot data on the use of EPT with MSM diagnosed with~     gonorrhea or chlamydia and form the basis for a subsequent Phase III clinical trial of EPT as~     an STI control method among MSM in Latin America.~   "
141082|NCT01720641|"~     The goal of the proposed research is to assess new strategies for partner management and~     sexually transmitted infection (STI) control to reduce the spread of HIV-1 among men who have~     sex with men (MSM) in Latin America. The HIV epidemic in Peru remains concentrated within the~     core risk group of MSM. STI infection and re-infection are central to the continuation of the~     HIV epidemic among MSM in Peru. Development of improved strategies for partner notification~     and treatment will reduce the incidence and prevalence of STIs and ultimately reduce the~     incidence of HIV infection in this population. The first phase of this study used qualitative~     methods to explore attitudes and practices related to partner notification among MSM in Lima,~     Peru. Findings from the qualitative research were used to develop a quantitative survey~     instrument to assess partner notification decision-making processes and practices among MSM~     in Peru recently diagnosed with HIV or syphilis infection. Data from both quantitative and~     qualitative phases of the study have been used to develop a partner notification for MSM in~     Peru. Investigators plan to implement and assess the impact of the intervention on rates of~     partner notification following a diagnosis of syphilis among MSM in Lima, Peru. The~     investigators hypothesize that participants randomized to receive one or more partner~     notification tools will report a higher frequency of partner notification.~   "
141088|NCT01720563|"~     Eighty to 90% of SCCHN (squamous cell carcinoma of head and neck) patients in Taiwan were~     betel quid chewers. Thirty to 40% of them experienced mucositis World Health Organization~     (WHO) grade 3 from cisplatin/flurouracil (FU) in neoadjuvant chemotherapy setting. This was~     higher than the 8-11% reported in the Western populations and was related to oral submucous~     fibrosis from betel quid chewing.Severer toxicities, esp. mucositis, could be anticipated in~     patients of betel quid chewing treated by concurrent chemoradiotherapy (CCRT) with~     cisplatin/FU.PG2 Injection is proved to be safe for clinical use and is effective in~     stimulating the recovery of hematopoiesis and immunity from chemotherapy-induced~     myelosuppression. It also improved the Quality of Life, especially in fatigue, among advanced~     cancer patients. This study will be investigated the effect of PG2 Injection in relieving the~     adverse events of concurrent chemoradiotherapy, such as fatigue, myelosuppression, mucositis,~     body weight loss, and even the compliance of radiotherapy and chemotherapy in treatment of~     patients with advanced pharyngeal or laryngeal SCCHN.~   "
141089|NCT01720550|"~     The objective of this study is to conduct a trial in the spirit of providing as much as~     possible the benefit of PG2 treatment to eligible patients and to evaluate the efficacy and~     safety of different doses of PG2 treatment for relieving fatigue among advanced cancer~     patients who are under standard palliative care (SPC) at hospice setting and have no further~     curative options available. Patient's fatigue status, to be measured by the Brief Fatigue~     Inventory-Taiwanese Form (BFI-T), will be the primary endpoint. The fatigue improvement~     response rate among patients between two study arms will then be compared as the basis for~     efficacy evaluation at the end of the first treatment cycle, and will be the primary~     endpoint. Other endpoints, the fatigue improvement response rate and the mean fatigue scores~     change from baseline among patients within and between cycles will be included in the~     secondary efficacy endpoints, and will be compared between two study arms. Patients' quality~     of sleep, appetite, pain, fatigue, nausea, vomiting and global quality of life (QoL) will be~     also measured by 11 questions (SS11) from EORTC(European Organization) for Research and~     Treatment of Cancer QLQ-C30 for secondary endpoint evaluation. The other secondary endpoints~     include Karnofsky performance scores, and weight change and its related c-reactive protein~     level of the patients.~   "
141090|NCT01720537|"~     This study is to evaluate the safety, tolerability and immunogenicity of single, ascending or~     multiple fixed subcutaneous and intravenous administrations of PF 05335810 to~     hypercholesterolemic subjects when added on to a daily statin dose.~   "
141091|NCT01720524|"~     This study will evaluate whether IV sildenafil can reduce the time on inhaled nitric oxide~     treatment and reduce the failure rate of available treatments for persistent pulmonary~     hypertension of the newborn.~   "
141092|NCT01720511|"~     This is a pilot study to demonstrate the effect of purple rice on post-prandial glucose and~     insulin. The purple color is due, like red wine grapes, mainly to the anthocyanins. The~     safety and tolerability of purple rice is similar to white or brown rice, but contains the~     purple elements common to other foods like grapes.~   "
141093|NCT01720498|"~     To find out the effect site concentration of remifentanil for preventing QTc interval~     prolongation during intubation under propofol-remifentanil anesthesia in elderly patients~   "
141094|NCT01720485|"~     The purpose of this study is to evaluate the non-inferiority clinical efficacy of two~     different drug associations in the treatment of Moderate - Severe Persistent Allergic~     Rhinitis in Adults.~   "
141095|NCT01720472|"~     The purpose of this study is to use the MURDOCK Horizon 1.5 infrastructure (Duke Instutional~     Review Board Pro00011196) to specifically target and enroll 1,000 participants across age~     groups and other demographic categories in order to develop a diverse cohort with specific~     physical and cognitive performance data paired with biological samples.~   "
141096|NCT01720459|"~     The purpose of this study is to determine whether micronized trans-resveratrol improves~     clinical (excessive hair, menstrual cycle), endocrine (androgens)and metabolic (lipids,~     markers of systemic inflammation) in women with polycystic ovary syndrome (PCOS).~   "
141097|NCT01720446|"~     This trial is conducted globally. The aim of the trial is to evaluate cardiovascular and~     other long-term outcomes with semaglutide in subjects with type 2 diabetes. The trial is~     event-driven, i.e. the maximum trial duration (up to max. 148 weeks) will depend on the~     accrual of major adverse cardiovascular events (MACE) in this trial and the remaining~     research programme. The incidence of MACE will be monitored throughout the trial which will~     be terminated according to plan when pre-specified stopping criteria are met.~   "
141098|NCT01720433|"~     Shoulder tip and abdominal pain following laparoscopic procedures are well recognized as~     causes of post-operative morbidity. This prospective, double-blind, randomized controlled~     trial attempts to reduce post-operative pain in patients undergoing laparoscopic surgery by~     implementing a simple intra-operative technique.~      Patients who undergo elective laparoscopic cholecystectomy for gallbladder disease or~     laparoscopic inguinal hernia repair will be recruited to the trial. Patients will be~     randomized to either the current standard (control group) or to receive an intervention to~     remove residual CO2. In the intervention group the pneumo-peritoneum will be removed, at the~     end of the operation, by placing the patient in the Trendelenburg position and utilising a~     pulmonary recruitment maneuver consisting of two manual inflations to a maximum pressure of~     60 cm H2O. In the control group residual pneumo-peritoneum will be evacuated at the end of~     the procedure by passive decompression via the open operative ports.~   "
141099|NCT01720420|"~     AN OPEN 5-YEAR PROSPECTIVE, CLINICAL MULTI-CENTER STUDY on NobelProcera Implant Bar Titanium~     with Locator attachment and related Overdenture on 4 NobelReplace implants with conical~     connection (CC) in the mandible/maxilla.~   "
141103|NCT01720368|"~     The investigators believe that patients with Crohn's disease are able to report details of~     their own medical history accurately and record changes in clinical status effectively over~     time. Using an internet-based database the investigators will ask patients to report their~     own disease history, and the investigators will compare their reports to the medical record.~   "
141104|NCT01720355|"~     Determine accuracy specifications and labeling claims of a pulse oximeter in a diverse~     subject population during severe signal interference over a specified saturation range.~   "
141105|NCT01720342|"~     The EASE Enable study is intended to collect additional data on the clinical outcomes of the~     Medtronic Enable® Aortic Bioprosthesis in real world patients.~   "
141107|NCT01720316|"~     The purpose of this study is to assess the efficacy of oral glycine as an augmentation~     strategy in two psychotic patients with a triplication (4 copies) of the gene glycine~     decarboxylase (GLDC). Subjects will first undergo a double-blind placebo-controlled clinical~     trial in which one 6-week arm will involve glycine (maximum daily dose of 0.8 g/kg,~     administered on a TID dosing schedule) and one 6-week arm will involve placebo. A 2-week~     period of no treatment will occur between treatment arms. A 6-week period of open-label~     glycine (maximum daily dose of 0.8 g/kg, administered on a TID dosing schedule) will follow~     the double-blind placebo-controlled clinical trial. Prior to the double-blind~     placebo-controlled clinical trial and at the end of the open-label glycine trial, the~     following procedures will be carried out: structural MRI (3T), Proton 1H MRS (4T), fMRI (3T),~     steady-state visual evoked potentials, and EEG. Positive, negative, and affective symptoms~     and neurocognitive function as well as plasma levels of large neutral and large and small~     neutral and excitatory amino acids and psychotropic drug levels will be assessed~     periodically. In addition, 1H MRS (4T) for 2 hours after a single oral dose of a~     glycine-containing drink will be assessed at baseline. Pharmaceutical grade glycine powder~     (Ajinomoto) or placebo will be dissolved in 20% solution and prepared by the McLean Hospital~     Pharmacy.~      Because the results of the double-blind placebo-controlled and open-label glycine treatment~     arms showed substantial clinical benefit to the participants, the study has been extended to~     include six months of chronic open-label glycine in order to determine 1) whether the~     clinical benefits achieved within 6 weeks previously recur, 2) the clinical benefits are~     lasting, and 3) additional clinical benefits occur with longer exposure. The glycine for this~     extension will be provided by Letco Medical.~      The investigators hypothesize that mutation carriers will have reduced endogenous brain~     glycine and GABA levels and increased brain glutamate and glutamine levels. Glycine~     administration will increase brain glycine in the two carriers, but to a lesser extent than~     in non-carrier family members and controls.~      The investigators hypothesize reduced activation of magnocellular pathways and abnormal ERPs~     modulated by NMDA in mutation carriers compared with non-carrier family members and controls.~      The investigators hypothesize that glycine, but not placebo, will improve positive, negative~     and affective symptoms as well as neurocognitive function.~      The investigators also hypothesize that open-label glycine will improve clinical and~     cognitive functioning, will partially normalize decreased baseline glycine and GABA and~     increased glutamate and glutamine, and will partially normalize magnocellular pathway~     activation and abnormal evoked potentials.~   "
141108|NCT01720303|"~     This trial is conducted in Asia. The aim of this trial is to compare oral anti-diabetic drug~     (OAD) combined with insulin vs. insulin alone in subjects with type 2 diabetes not adequately~     controlled on the current OAD therapy.~   "
141109|NCT01720290|"~     This trial is conducted in Asia. The aim of this trial is to compare repaglinide and~     metformin administered alone or in combination in subjects with type 2 diabetes.~   "
141110|NCT01720277|"~     The purpose of this pilot evaluation is to help determine the feasibility and power needed to~     prospectively evaluate relative effectiveness of high-dose influenza vaccine in preventing~     influenza mortality and hospitalization in a nursing home population in the U.S., compared to~     the standard-dose influenza vaccine.~   "
141111|NCT01720264|"~     The main purpose of this trial is to assess the efficacy and safety of sitagliptin in~     enhancing engraftment following umbilical cord blood transplantation (recovery of blood~     counts after transplant).~   "
141112|NCT01720251|"~     The main objective of the trial is to demonstrate the efficacy of a two months pre-seasonal~     treatment with AllerT 100 µg maintenance dose in reducing symptoms of allergic~     rhinoconjunctivitis during the following birch pollen season~   "
141113|NCT01720238|"~     Though newly reported HBV infection and HBsAg prevalence in China have greatly decreased,~     patients who had been chronically infected with HBV, especially those with liver cirrhosis~     cause great burden on public health care. In view of economic development level, drug~     availability and lack of independent health economics evidence, the investigators are still~     unable to give specific guidelines for HBV related compensated liver cirrhosis in China.~     Therefore, the investigators aim to investigate clinical effects and cost-effectiveness of~     two early anti-viral therapy strategies on HBV related compensated liver cirrhosis through~     this prospective, open-label, multicenter and nonrandomized study.~   "
141114|NCT01720225|"~     The goal of this clinical research study is to compare how two different drugs, decitabine~     and azacitidine, when given on a shorter than standard dosing schedule can help to control~     MDS. The safety of the drugs will also be studied.~      Decitabine is designed to damage the DNA (the genetic material) of cells, which may cause~     cancer cells to die.~      Azacitidine is designed to block certain proteins in cancer cells whose job is to stop the~     function of the tumor-fighting proteins. By blocking the bad proteins, the tumor-fighting~     genes may be able to work better. This could cause the cancer cells to die.~   "
141115|NCT01720212|"~     To evaluate the safety and plasma concentration change of YM178 after single- and~     repeated-administration as oral absorption controlled tablet in healthy Chinese subjects.~   "
141116|NCT01720199|"~     This is a field study aiming to evaluate a school-based prevention intervention, Diario della~     Salute (DDS).~   "
141117|NCT01720186|"~     This is a pilot study, single-center, prospective, open-label, to assess the acceptability~     and performance of the experimental medical device (SPI) used during an imaging examination~     (PET / CT 4D imaging in synchronized mode centered on the thorax). Each patient will be its~     own control, since the imaging examination will be synchronized simultaneously with the two~     systems: tested Medical Device (SPI) and reference Medical Device(RPM).~   "
141118|NCT01720173|"~     This phase II trial studies the side effects and how well dalantercept works in treating~     patients with ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer that~     has returned. Dalantercept may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. Dalantercept may also stop the growth of tumor cells by blocking~     blood flow to the tumor.~   "
141119|NCT01720160|"~     The purpose of this research study is to show whether the Neo system is safe and works in~     people with heart failure. The study is currently in long-term follow up.~   "
141120|NCT01720147|"~     Fanconi anemia (FA) is an autosomal recessive disease characterized by progressive bone~     marrow failure (BMF), congenital abnormalities and a predisposition to malignancy.~   "
141121|NCT01720134|"~     Multiple pregnancy (MP) is associated with significant fetomaternal complications and a high~     cost. The multiple pregnancy rate per cycle (MPR) of treatment with Assisted Reproductive~     Technology (ART) is 25 % or higher even in countries where ART is reimbursed, much higher~     than the 1% after natural conception, related to the number of embryos transferred, and~     preventable by single embryo transfer (SET). In Belgium, the laboratory costs for 6 fresh ART~     cycles are reimbursed for female patients younger than 43 with a Belgian insurance number~     since July 2003, but only if a limited number of embryos is transferred depending on female~     age and cycle rank. Although this policy has resulted in a significant reduction in the MPR~     after ART in Belgium from 24 % to 13 %, available data are cycle based and it is unknown if~     the cumulative delivery rate per patient is affected by this legislation. The aim of this~     study was to test the hypothesis that Belgian ART legislation since 2003, coupling lab~     reimbursement to restriced embryo transfer policy, has resulted in a reduced CDR when~     compared to the situation before 2003.~   "
141125|NCT01720082|"~     Laparoscopic appendectomy (LA) is nowadays considered the gold standard in fertile women~     affected by uncomplicated appendicitis. The level of evidence for benefits from LA in this~     subgroup is high. Since the dissemination of single access surgery (no-scars surgery)~     ameliorated outcome has been supposed in these patients regarding post-operative pain,~     hospital stay and cosmetics results, and keeping the same safety as LA. This randomized~     controlled study is supposed to give answers to these questions.~   "
141126|NCT01720069|"~     To evaluate the clinical efficacy, safety, tolerability and dose-response relationship, using~     oral corticosteroid (OCS) modulation, of 3 different doses of VR506 using a twice daily~     regimen from a new dry powder inhaler (nDPI) for 16 weeks in subjects with severe persistent~     asthma requiring OCS therapy, i.e. Step 5 treatment as defined by modified Global Initiative~     for Asthma (GINA) guidelines 2011.~   "
141127|NCT01720056|"~     Keloid scarring is a severe cosmetic and painful disease of the skin. The gold standard~     treatment is yet to be clarified. This randomized clinical pilot study will compare the~     effects of two local treatments for preventing keloid recurrence after surgical removal;~     steroid and verapamil.~      Study hypothesis: Intralesional therapy with the calcium antagonist verapamil has equal~     treatment efficacy as steroid injection.~   "
141128|NCT01720043|"~     To evaluate the effect of VELCADE on platelet aggregation at baseline, 24 hours and 48 hours~     after infusion in patients with multiple myeloma~   "
141129|NCT01720030|"~     We hypothesise that levosimendan will have a positive influence on renal function during~     acute kidney injury in adult intensive care patients.~   "
141130|NCT01720017|"~     The overall purpose of this study is to assess the impact of preclinical airway manikin~     training using the Airtraq Avant and Wireless Monitor System under simulated difficult airway~     conditions (c-collar and swollen tongue) on the clinical learning curve of using the~     device/system in airways with predictors for difficult intubation.~      The investigators hypothesize that the clinical learning curve in airways with predictors for~     difficult intubation will be shorter for study subjects (operators) who undergo preclinical~     manikin training under simulated difficult airway conditions compared to Study subjects~     (operators) who do not receive this training. The clinical learning curve is characterized by~     procedure times and first attempt success rates on successive uses of the Airtraq Avant and~     Wireless Monitor System in patients with at least one predictor for difficult intubation.~   "
141131|NCT01720004|"~     The investigators designed a pilot randomized controlled trial to assess the feasibility and~     acceptability of repeated hands-and-knees positioning during labour. The objectives were 1)~     to provide an estimate of enrollment rates, 2) to assess compliance with the study protocol~     by participants and care providers, 3) to obtain women's views about their experiences using~     the hands-and-knees position, and 4) to provide estimates of treatment effects to inform the~     sample size calculation for a large trial.~   "
141132|NCT01719991|"~     The purpose of this study is to implement a pragmatic intervention in four (4) family~     medicine groups(FMGs) in the region of Saguenay-Lac-Saint-Jean (Quebec, Canada)for patients~     with chronic diseases.~   "
141133|NCT01719978|"~     Among the adjuvants to local anaesthetics (LA), the enzyme hyaluronidase is most often used~     as a diffuser agent of the LA in ophthalmic anaesthesia. It serves to improve clinical~     efficacy and prolong anaesthesia as an alternative to long-lasting and potentially more~     dangerous LA, especially in patients with increased cardiovascular risk. There is scarce~     clinical data about the safety of the use of hyaluronidase in dental procedures.~      This study aimed to compare hemodynamic and electrocardiographic variables during a dental~     surgical procedure using a local anaesthetic associated with hyaluronidase or placebo in~     healthy subjects.~   "
141134|NCT01719965|"~     A popular form of community engagement is for the researchers to interact with a Community~     Advisory Board. The Shoklo Malaria Research Unit has been working on the Thai-Burmese border~     for many years and has been informally engaging with the community for its healthcare and~     research initiatives, especially in the area of ethics and consent. In January 2009,~     community engagement was formalised with the establishment of the Tak Province Border~     Community Ethics Advisory Board (T-CAB). The T-CAB is the first of its kind as the~     investigators have not come across any set up of similar nature involving mobile and unstable~     populations residing along a porous border.~      Three years on, SMRU questions if the T-CAB has been successful and if the current T-CAB~     model is the best model for this community. In order to evaluate the T-CAB, first an~     evaluation tool has to be developed as there are no off-the-shelf evaluation tools for CABs,~     then the evaluation will be carried out.~   "
141135|NCT01719952|"~     A double-blinded randomised control trial conducted in the Department of Obstetrics and~     Gynaecology of a tertiary hospital, Universiti Kebangsaan Malaysia Medical Centre (UKMMC) for~     two years duration from January 1st, 2012 till December 31st, 2013.~      The aim of the study is to compare the haemodynamic and cardiovascular effects between~     intravenous carbetocin 100 μg and intravenous oxytocin 5 IU in women undergoing elective~     Lower Segment Caesarean Section (EL LSCS).~      Study hypothesis: A single injection of carbetocin is haemodynamically and cardiovascularly~     safe and has similar efficacy in comparison to a single injection of oxytocin.~   "
141136|NCT01719926|"~     Mesenchymal stem cells (MSCs) are present in the circulation of cancer patients, and are~     recruited to the stroma of both the primary tumor and metastasis. Recent preclinical research~     has shown that in response to platinum-based chemotherapy, MSCs secrete two specific~     platinum-induced fatty acids (PIFAs) which induce resistance to a broad spectrum of~     chemotherapies. The secreted PIFAs are the fatty acid oxo-heptadecatetraenoic acid (KHT) and~     the omega-3 fatty acid hexadecatetraenoic acid (16:4). These PIFAs are produced via the COX-1~     pathway. COX inhibitors, including indomethacin. This phase 1 study explores the safety of~     combining indomethacin with platinum containing chemotherapy.~   "
141137|NCT01719913|"~     Objective: To identify how specific changes of the gluten content in the diet affect the~     host-gut microbiome interactions with implications for metabolic health.~      Design: A randomized, controlled, single-blinded, cross-over intervention trial consisting of~     two 8-week interventions periods, separated by a 6-week wash-out period. A total number of 60~     participants will be included.~      Intervention: low vs high gluten intake.~   "
141162|NCT01719588|"~     The purpose of this study is to evaluate the safety and effectiveness of prolonged release~     tapentadol hydrochloride for the relief of moderate to severe chronic non-cancer pain among~     Filipino patients.~   "
141138|NCT01719900|"~     The recent dramatic increase in obesity has been linked to a reduction of dietary fibre~     intake. We hypothesized that supplementing the diet of overweight and obesity adults with~     pulse fibre will improve their metabolic status, chiefly defined as greater weight loss.~     Other metabolic health improvements may include improved glucose control and reduced~     inflammatory markers.~   "
141139|NCT01719887|"~     Humeral shaft fractures represent 1-3% of all fractures and 20% of the humeral fractures.~     These fractures have historically been treated mainly conservatively with good results.~     Recent development in fracture treatment and findings that certain fracture types are more~     prone to non-union and bracing-related functional problems of adjacent joints are somewhat~     common have caused increasing interest in treating these fractures surgically. Return to~     activities is also considered to be quicker among surgically treated patients.~      The purpose of this study is to evaluate effectiveness and cost-effectiveness of surgical~     treatment of humeral shaft fractures. Patients with an unilateral humeral shaft fracture who~     are willing to participate in the study after informed consent are randomly assigned to two~     different treatment methods:~        1. Surgical treatment with an open reduction and internal fixation with a 4,5mm locking~          plate.~        2. Conservative treatment with functional bracing~      The randomization is done using blocked randomization (block sizes are not known by the~     enrolling or assigning phycisian) and stratification is done according to fracture type~     (AO-OTA type A vs. type B/C) and radial nerve status (total/subtotal motor palsy vs. no~     palsy).~      Standard follow-up visits at 6 weeks, 3, 6 and 12 months are arranged. Later follow-up visits~     are arranged at 2, 5 and 10 years for the study purpose. Patients fill evaluation forms and~     clinical and radiological assessments are made. The physiotherapist doing objective~     functional measurements is blinded to treatment method. Both study groups receive~     physiotherapy after the initial treatment.~   "
141140|NCT01719874|"~     The purpose of this study is to determine the safety and efficacy of TCN-032 given to healthy~     adult volunteers that have been inoculated with the influenza A virus~   "
141141|NCT01719861|"~     Intrapatient dose escalation study of desipramine in subjects with small cell lung cancer~     (SCLC) and other high-grade neuroendocrine tumors.~   "
141142|NCT01719848|"~     Failure of advanced airway security has been reported that it could lead lethal complication~     such as brain hypoxic damage. There have been controversial reports for the airway assessment~     tests which can predict difficult laryngoscopy. Therefore, we evaluated diagnostic validity~     of pre-existing airway assessment tests and scoring system using a gray zone approach in~     patients undergoing general anesthesia required endotracheal intubation.~   "
141143|NCT01719835|"~     This is a randomised, open-label phase II study comparing GEM-P chemotherapy (experimental~     arm) with CHOP (control arm) in previously untreated T-cell lymphoma. Eligible patients will~     be randomised 1:1 between 4-weekly GEM-P or 3-weekly CHOP chemotherapy.~   "
141144|NCT01719822|"~     Patients with chronic lung diseases such as Chronic Obstructive Pulmonary Disease (COPD), who~     perform regular physical activity, have improved health and wellbeing compared with those who~     do little exercise. The purpose of the study is to evaluate whether the use of a simple~     pedometer (step counter) to set targets for daily physical activity can encourage COPD~     patients referred for an 8-week pulmonary exercise based programme (PR) to be more active.~     The investigators also want to know whether the use of pedometers during PR can improve~     adherence, self-management and outcome in COPD.~   "
141145|NCT01719809|"~     This is a prospective, observational, single-center study. Patients with at least 3 months of~     experience using topical medications for glaucoma and who state that they administer their~     own eye drops will be recruited. Subjects will be videotaped instilling a sterile artificial~     eye drop, will be identified at the time of a regularly scheduled exam. If the patient can~     get a drop onto the eye and also not touch their lids or ocular surface with the eye drop~     bottle, the subject will be thanked but not enrolled. All other patients who agree to~     participate will be enrolled. Upon completion of videotaped instillation of an eye drop, each~     enrolled patient will be shown a video demonstrating an instillation technique and will be~     given an instructional handout highlighting a proper drop instillation technique. If~     necessary, an instillation technique will be demonstrated to them by an investigator or~     trained personnel.~      A patient will be identified as properly instilling a drop if they satisfy the following~     criteia:~      They are able to instill one (and only one) drop to the ocular surface or lower fornix~     without allowing the bottle touch the adnexa, eyelid, eye lashes or eye.~      All patients routinely return between 3 and 6 months. At this regularly scheduled visit,the~     investigator or trained personnel would direct the patient to instill an eye drop into the~     study eye.Additionally, the short glaucoma self-efficacy questionnaire will be~     re-administered.~      All of the video-recordings of participants' eye drop instillation techniques will be~     reviewed and assessed using a standard checklist. Their ability to administer an eye drop~     after training will be compared to baseline.~   "
141146|NCT01719796|"~     Abdominal surgery impairs ventilation. Postoperative pain accounts for this impairment.~     Regional analgesia is known to reduce pain, thus to limit ventilatory impairment. The~     investigators hypothesized bilateral continuous transverse abdominal plan block would reduce~     ventilatory impairment following abdominal surgery.~   "
141147|NCT01719783|"~     To evaluate the safety profile of two intranasal doses of LAIV A/17/turkey/Turkey/05/133~     (H5N2) in healthy adults.~   "
141163|NCT01719575|"~     The purpose of this study is to compare the effects of Motilitone and placebo on gastric~     volumes, gastric emptying, small bowel transit and colon transit in female and male healthy~     volunteers.~   "
141164|NCT01719562|"~     This trial studies how well magnetic resonance imaging (MRI) works in detecting heart damage~     in patients with cancer receiving chemotherapy. Diagnostic procedures, such as MRI, may help~     doctors predict whether patients will have heart damage caused by chemotherapy in patients~     with cancer receiving chemotherapy.~   "
141165|NCT01719549|"~     This is a single-center, prospective, single-arm, open-label phase II study~   "
141166|NCT01719536|"~     The purpose of this study is to compare icotinib with induction and maintenance chemotherapy~     in the first-line treatment of advanced non-small cell lung cancer (NSCLC) patients with EGFR~     mutation.~   "
141167|NCT01719523|"~     The purpose of this study is to examine the effects of EPI-743 on tic severity in adults with~     Tourette syndrome.~   "
141148|NCT01719770|"~     Mild hypothermia improves neurological outcome after cardiac arrest. Neuromuscular blockers~     are in use, together with analgesia and sedation, during the cooling process in many centers~     to prevent shivering. Since neuromuscular blockers are accused to be associated with various~     side effects causing serious harm and/or leading to prolong ICU stay. So economical use seems~     to be reasonable. Furthermore, the use of neuromuscular blockers may mask epileptic activity.~     Therefore, post hypoxic seizures might remain undetected.~      Aim of this study is to investigate if a continuous application of neuromuscular blockers is~     necessary to prevent shivering and thereby avoid the counter regulation to achieve the target~     temperature as soon as possible in mild hypothermic therapy after cardiac arrest.~      A single center (university hospital) study. Randomized, double blinded, double dummy study~     design. Eligible are all adult patients after successful resuscitation due to cardiac arrest~     of presumed cardiac origin.~      All patients receiving mild therapeutic hypothermia after cardiac arrest of presumed~     cardiopulmonary origin will be included.~      Patients <18 years, cardiac arrest >6 hours before admittance at the hospital, patients with~     known or clinically apparent pregnancy, patients who reach our hospital with a body~     temperature below 35°C, patients with known allergic reactions against rocuronium, patients~     with a history of myasthenia gravis, patients with obvious intoxication, wards of the~     state/prisoners and patients with known epileptic disease will be excluded.~      Primary outcome:~      Shivering episodes will be scored with the Shivering Assessment Scale.~      Secondary outcome:~      Total doses of rocuronium, time to target core temperature of 33°C, dissipated energy and~     total energy needed during the cooling period will be compared between the two groups.~      Changes in basal metabolism and depth of relaxation will be ascertained. Furthermore, serum~     levels of midazolam, fentanyl, rocuronium and stress hormones will be measured.~      Train-of-four will be performed to assess the depth of relaxation. Sedation will be monitored~     via bispectral index; measurement of metabolic activity will be evaluated using indirect~     calorimetry. Additionally, EEG will be performed to detect epileptiform activities. Blood~     will be drawn to measure levels of midazolam, fentanyl and rocuronium.~   "
141149|NCT01719757|"~     The aim of the study is to evaluate the efficacy of TARGIN administration as an analgesic to~     Korean patients treated with opioid analgesics for moderate-to-severe cancer pain under~     conditions of daily practice.~   "
141150|NCT01719744|"~     This is a phase 2 study of ENMD-2076 in patients with advanced/metastatic soft tissue~     sarcoma. This study will help to understand how well ENMD-2076 works and how safe and~     tolerable the drug is in this patient population.~   "
141151|NCT01719731|"~     Recent research suggests that BPD is a common, serious but treatable disorder with a better~     than previously recognized prognosis. Despite these findings, many patients with BPD are not~     given the borderline diagnosis by the mental health professionals treating them. It is also~     true that many newly diagnosed borderline patients are not provided with up-to-date~     information on the disorder even though psychoeducation has been found to be a useful form of~     treatment for other serious psychiatric illnesses.~      The investigators have conducted a preliminary randomized trial of psychoeducation for BPD~     that found that those provided with immediate psychoeducation had a significantly greater~     reduction in two core symptoms of BPD--general impulsivity and stormy relationships--than~     those with delayed psychoeducation.~      However, both instruction and assessment of change over time were conducted in person by~     paraprofessionals. The importance of the current study is that it will allow the~     investigators to develop and test the efficacy of an internet-based program of~     psychoeducation for BPD that will be both cost efficient and easy to disseminate widely,~     particularly to underserved populations.~   "
141152|NCT01719718|"~     A multicenter prospective randomized controlled trial comparing closure versus non-closure of~     the hernia defect between 2 and 5 cm in width using a tissue separating mesh (Physiomesh™) in~     laparoscopic ventral hernia repair.~   "
141153|NCT01719705|"~     Post-cesarean pain management is essential for early mobilization of the mother so that she~     becomes able to care of her newborn. There choices for postoperative analgesia include~     spinal, systemic, or both opioids, non-steroidal anti-inflammatory drugs (NSAIDs), local~     anesthetic infiltrations of the wound, or transverse abdominis plane blocks, which are~     determined by drug availability, regional and individual preferences, resource limitations~     and financial considerations. The use of opioids is associated with adverse effects such as~     nausea, pruritus, sedation, and occasionally respiratory depression.~      Pregabalin is an anticonvulsant drug structurally related to the inhibitory neurotransmitter~     gamma amino butyric acid, that exerts its action by binding to the α-2-δ subunit of the~     voltage-dependent calcium channel. It reduces the release of the excitatory neurotransmitters~     and inhibits the hyperalgesia and central sensitization.~      A recent meta-analysis demonstrated that pregabalin reduce the postoperative 24 hours~     cumulative opioid consumption and opioid-related adverse effects namely, vomiting and visual~     disturbances after surgery. Compared with the use of pregabalin doses lower than 300 mg, the~     use of doses higher than 300 mg even reduced opioid consumption by 35%.~      It is not known if pregabalin is excreted in human milk. There is a case report on the~     extensive excretion of pregabalin in breast milk, but with low measured concentrations in~     infant as a consequence of maternal exposure during breast feeding. Food and Drug~     Administration recommends to discontinue nursing or to discontinue pregabalin in nursing~     mothers. Pre-delivery single exposure to pregabalin is expected to be safe for the newborns.~      Up to the authors' best knowledge, this is the first clinical study on the efficacy and~     safety of the administration of pregabalin before cesarean delivery.~      We hypothesis that the preoperative administration of a single dose of pregabalin will~     improve the quality of postoperative analgesia after cesarean delivery.~      This placebo-controlled study aims to compare the effects of preoperative administrations of~     single oral doses of pregabalin 150 mg and 300 mg on the postoperative pain scores,~     cumulative patient controlled morphine consumptions, neonatal Apgar and neurologic and~     adaptive capacity scores (NACS), and maternal and neonatal adverse effects in parturients~     scheduled to elective Cesarean delivery under spinal anesthesia.~   "
141154|NCT01719692|"~     A comparative study with rituximab (100 mg weekly for 4 weeks and 375mg/m2 for once) shows~     low dose rituximab may be a useful alternative therapy in patients with ITP.The aim of this~     study is to compare the efficacy and tolerability of two different regimens of low doses~     rituximab for the treatment of adult patients with ITP.~   "
141155|NCT01719679|"~     The provision of adolescent vaccination in a school setting will be feasible and acceptable~     to parents as evidenced by the number and percentage of students immunized within each school~     compared to those in schools without a program. The likelihood of vaccination for diphtheria,~     tetanus, and pertussis (Tdap), human papillomavirus (HPV), and meningococcal conjugate~     vaccine (MCV4) and all three combined) among eligible students enrolled in schools with a~     comprehensive school-based immunization program will be significantly higher than that of~     students enrolled in schools without a school-based immunization program.~   "
141156|NCT01719666|"~     The investigators hypothesis is lateral retinaculum release has no effect on treatment of~     Patellar Recurrent Dislocation with Medial Patellofemoral Ligament (MPFL) reconstruction.~   "
141157|NCT01719653|"~     The purpose of this investigation is to compare 3 versions of MiraLAX/Gatorade, MoviPrep and~     SUPREP to see which preparation cleanses the colon best and which preparation is best~     tolerated.~   "
141158|NCT01719640|"~     Cell injury in human islets induced by non-immune mediated inflammation occur in vitro upon~     hyperglycemia in type 2 diabetes mellitus. Infusion of autologous bone marrow mononuclear~     cells (BMMNCs) is an emerging therapeutic approach for DM, which showed promising outcomes~     with mild side effects. Infusion of BMMNCs and autologous bone marrow mesenchymal stem cells~     in combination might exert enhanced repairing effects. We hypothesized that infusion of these~     two classes of cells might provide multiple signals for regeneration and improve recovery~     from inflammation-induced lesion. The effects might be maximized by intra-arterial pancreatic~     infusion.~   "
141168|NCT01719510|"~     The main objective of this study : Demonstrate that GBS (group B streptococci) ST-17~     colonize and persist to 60 days twice in the digestive tract of newborns that strains of GBS~     non-ST-17.~      Secondary objectives:Determine:~        -  The frequency of colonization with GBS ST-17 and GBS non-ST-17 of at risk pregnant~          women.~        -  The frequency of colonization of neonates by GBS ST-17 at birth.~        -  The preferential site of colonization in the mother (rectum, vagina, breast milk).~        -  The kinetics of colonization after birth in the newborn.~        -  The sensitivity and specificity of different GBS detection methods (conventional~          phenotypic versus molecular) in the different types of samples from the mother and the~          newborn.~   "
141169|NCT01719497|"~     The aim of the present study is to conduct a human trial of [C-11]OMAR, a new PET imaging~     agent for the brain cannabinoid type 1 receptors (CB1), to determine its pharmacokinetics and~     binding characteristics.~   "
141170|NCT01719484|"~     To examine the influence of obesity on brain activation during food cue, stress, and neutral~     relaxing conditions~   "
141171|NCT01719471|"~     To examine the influence of current daily tobacco smoking on brain activation during stress,~     tobacco cue, and neutral relaxing conditions~   "
141172|NCT01719458|"~     In this study we propose to study 24 unmedicated abstinent alcohol dependent patients, 24~     obese individuals and 24 individually matched healthy control subjects and determine~     Norepinephrine Transporter (NET) expression in vivo using (S,S)-[11C]MRB and PET.~   "
141173|NCT01719445|"~     The Primary Aim of the project is to modify the RFPM for adolescents and to address the~     concerns identified by the reviewers of the first grant application. We will then test the~     RFPM's validity (accuracy) compared to the validity of pen-and-paper food records.~   "
141174|NCT01719432|"~     Studies have shown that different percentages of body fat can alter the way drugs are~     distributed in the body. This study will use blood samples taken at different time points for~     patients taking Neupogen to determine if higher body weights affect drug exposure. The~     information gathered from this study will help understand if patients with higher body~     weights need a different dosing plan.~      Patients in this study will have blood draws once before they take Neupogen and 6 times after~     they take the Neuopen (for a total of 24 hours). These patients will be in the hospital~     already and will not need to make additional trips back to have blood drawn. A total of about~     5-6 tablespoons of blood will be drawn for this study. 15 obese patients and 15 matched,~     non-obese patients will be enrolled into this study.~   "
141175|NCT01719419|"~     The purpose of this study is to determine if the drug orlistat (Alli, Xenical) decreases the~     taste for fat in humans.~   "
141176|NCT01719406|"~     Personal behaviors can influence development of Gestational Diabetes Mellitus (GDM), a~     condition that can adversely affect the pregnant woman, her developing fetus and future~     events for both. To reduce GDM risk, we will develop and implement an in-person team and~     web-based nutrition and exercise program for women, beginning in their first trimester. A~     scripted, peer-led, 20-week educational program, tailored for pregnant women working in teams~     (5 women/team), will be developed and implemented among pregnant employees and/or their~     spouses. Each weekly thirty minute session will focus on achieving 30-minutes of moderate~     daily physical activity with nutrition targets of five servings of fruits and vegetables, 3~     servings of whole grains and lower fat food choices. Diet, exercise and lab assessments will~     occur before enrollment during the first trimester, each subsequent trimester and 12 weeks~     after delivery. In addition to exercise and diet survey results, we will assess fasting~     glucose, insulin, hemoglobin A1C levels, pregnancy weight gain, blood pressure, lipid and~     lipoprotein levels, pedometer records, weekly accelerometer data, each trimester and at 12~     weeks post delivery, as well as gestational birth age, Apgar score, delivery mode and infant~     birth weight, and weekly health thermometer self-ratings during the assessment period.~   "
141177|NCT01719393|"~     Our hypothesis is that radial arterial pulse may reflect the severity and airway function in~     asthmatics. The aims of this study are to investigate the pulse spectrim of the radial artery~     in adult asthmatics, and evaluate its correlation with airy inflammation an lung funtion in~     asthmatics.~   "
141178|NCT01719380|"~     This study will assess the safety and efficacy of LGX818 when combined with cetuximab or~     combined with cetuximab and BYL719 in patients with BRAF mutant metastatic colorectal cancer~   "
141179|NCT01719367|"~     Atrial fibrillation (AF), the most common sustained heart rhythm disorder, is becoming~     increasingly prevalent in the Western world. The number of people with AF in the United~     States is projected to roughly double by the year 2050, to an estimated 6-12 million. For~     many patients with AF, rate control with atrioventricular (AV) node blockers is a widely~     accepted therapeutic strategy. These agents control heart rate, thus preventing symptoms and~     systolic heart failure associated with tachycardia due to a rapid ventricular response to AF.~     Beta-blockers are widely accepted as first line agents for rate control in AF, especially~     when patients have concomitant hypertension (HTN), coronary artery disease, cardiomyopathies,~     or heart failure (HF). As a class, beta-blockers are among the most commonly prescribed~     cardiovascular medications.~      Among patients with AF treated with beta-blockers, the heart rate (HR) response varies~     substantially. Sometimes, adequate rate control can be achieved by titration of the~     beta-blocker dose; but frequently, additional AV nodal blockers and/or digoxin are necessary.~     In some cases, adequate rate control cannot be achieved even with the simultaneous use of~     multiple AV nodal blockers, necessitating mechanical ablation of the AV node and permanent~     pacemaker implantation.~      Patient-specific variables that influence the response to beta-blockers include comorbid~     conditions, weight, age, and level of physical activity. Ethnic differences in the response~     to beta-blockers for the treatment of HTN and HF are well-described. However, the~     contribution of genetic variants to beta-blocker efficacy in AF is unknown. We propose to~     study, using a candidate gene approach, the effect of genetic variants on heart rate response~     to beta-blockade in patients with AF.~   "
141206|NCT01719016|"~     Diagnosis of relative contributions of large artery blockages and microvascular blockages is~     very much needed in the treatment of coronary artery disease. In order to achieve this, two~     novel parameters, pressure drop coefficient (CDP), which combines flow and pressure readings~     and Lesion flow coefficient (LFC), which combines anatomical details of the lesion with~     pressure and flow readings, are being investigated.~   "
141180|NCT01719354|"~     This is a trial to examine the effects of aftercare for mental health patients in community~     health center (Leistad). Recruitment occurs among hospitalized patients in psychiatric~     hospitals (Østmarka). After discharge, patients will be randomly assigned to one of two~     groups: intervention group (community health center, primary care) or control group~     (Community mental health centers of District Psychiatric Service, specialist care).~      The project's primary objective is to investigate the effect of community services on~     patients' functional capacity and user satisfaction after discharge. Secondly, the number of~     treatment days and readmissions to mental health care will be examined. The project will also~     compare costs of hospitalization, in psychiatric hospital and community health center~     respectively. Data will be collected from community health records, medical records and~     patient systems in psychiatric hospital, community mental health centers of District~     Psychiatric Service (DPS) and questionnaires filled out by patients.~   "
141181|NCT01719341|"~     Allogeneic haematopoietic stem cell transplantation (HSCT) is a potentially curative therapy~     for patients with both haematological and some non-haematological disorders. However, one of~     the major limiting factors for transplantation is the inability to identify a suitable~     HLA-matched donor. Development of an cost-effective and clinically efficacious alternative to~     HLA-identical sibling or unrelated donor transplantation would significantly expand the~     availability of allogeneic HSCT to patients in Singapore. Preliminary results indicate that~     the use of high dose post-transplant cyclophosphamide (Cy) for graft versus host disease~     (GVHD) prophylaxis in haplo-identical allogeneic HSCT is associated a low incidence of GVHD~     and low treatment related toxicity. We propose a phase II clinical trial to assess the~     efficacy of a haplo-identical allogeneic transplantation protocol using high dose~     post-transplant Cy for the treatment of patients with haematological disorders. A~     non-myeloablative protocol (Fludarabine-low dose cyclophosphamide-TBI) will be used for~     patients with bone marrow failure syndromes and indolent lymphoid disease. In view of the~     higher relapse risk of patients with myeloid malignancies, these patients will be treated~     with a reduced intensity conditioning regimen (Fludarabine-Busulphan). The primary end-point~     of the study will be overall survival at one year. Economic cost of the haplo-identical~     transplantation, as well as treatment timelines will be recorded and compared will other~     forms of unrelated donor allogeneic transplantation (umbilical cord blood transplantation and~     unrelated HLA-matched adult donor). Immunological reconstitution of patients following~     haplo-transplantation will be analysed and data will be utilized to guide future~     immunotherapy strategies post-transplantation.~      One year survival after non-myeloablative haploidentical stem cell transplantation is not~     inferior to that observed after non-myeloablative volunteer unrelated donor or unrelated cord~     blood haematopoietic stem cell transplantation.~   "
141182|NCT01719328|"~     The purpose of this study is to examine the immediate and cumulative effects of yoga on~     stress and mood among young adult college students attending an 8-week program in Vinyasa~     yoga.~   "
141183|NCT01719315|"~     The goal of this project is to examine the neurophysiology of hypersomnia during sleep and~     wakefulness, to identify biomarkers for excessive sleepiness in neuropsychiatric disorders,~     and pilot acoustical slow wave induction during sleep in patients with hypersomnolence, to~     determine if this decreases daytime sleepiness in these patients. The primary study~     hypotheses are that individuals with hypersomnolence will have reduced slow wave activity~     (SWA) during sleep and increased waking theta/alpha activity during wake in specific brain~     regions. A secondary hypothesis is that acoustical slow wave induction in hypersomnolent~     patients will increase SWA during sleep, reduce theta/alpha activity during wake, and improve~     subjective sleepiness.~   "
141184|NCT01719302|"~     Chemotherapy treatment with docetaxel and gemcitabine is a standard treatment for patients~     with soft tissue sarcoma. This study is designed to explore whether the addition of tyrosine~     kinase inhibitor pazopanib enhances the anticancer effect of the chemotherapy drugs.~      The Phase I component of this study is designed to determine the maximum tolerated dose of~     pazopanib when given with docetaxel and gemcitabine. The Phase II component is designed to~     determine the overall response rate of the combination of docetaxel, gemcitabine and~     pazopanib prior to surgical resection in patients with soft tissue sarcoma.~   "
141185|NCT01719289|"~     Background: depression during pregnancy is an important problem for public health. It has~     direct consequences for the affected woman, her children and family, and is a strong~     predictor of post-partum depression. In developing countries depression during pregnancy is~     highly common, and usually unrecognized and untreated.~      Aim: to evaluate the effectiveness and cost-effectiveness of an intervention delivered by~     nurse assistants in the management of pregnant women with depression in primary care clinics~     that adopt the Family Health Strategy in Sao Paulo, Brazil.~      Method: PROGRAVIDA is a cluster randomized controlled trial with pregnant women with~     depression attending pre-natal care in 12 Primary Care Units with Family Health Program,~     covering an area of 400,000 inhabitants in Sao Paulo, Brazil. The intervention follows a~     stepped-care approach and is delivered by health professionals working at the primary care~     unit responsible by the care of the women. All women from the intervention group receive a~     program based on psycho-education and problem solving techniques, delivered by a nurse~     assistant at the women's homes. The program comprises 8 sessions, 6 during pregnancy and 2~     after delivery. Intensity of depressive symptoms is assessed using the PHQ-9, at the~     beginning of the sessions. Women with severe depression are referred to the family doctor and~     are assessed for the need of antidepressant medication. The control group receives routine~     care. The primary outcome is remission of depressive symptoms 4-months after the inclusion in~     the study. Secondary outcomes include remission of depressive symptoms at 6 months after~     delivery. Women are also assessed for socioeconomic and household characteristics, social~     support and obstetric complications. The effectiveness and cost-effectiveness of the~     intervention will be assessed with intention-to-treat analysis, using the clinical outcome~     and the assessment of quality of life (EQ-5D) four months after inclusion in the trial.~   "
141186|NCT01719276|"~     The purpose of this study is to compare the efficacy of graded activity program and~     supervised exercise on pain, functional disability, quality of life, global perceived effect,~     return to work, physical activity, physical capacity and strength of the lower limbs in~     patients with chronic non-specific low back pain~   "
141187|NCT01719263|"~     This study is designed to demonstrate safety and efficacy in patients with severe upper lobe~     predominant emphysema. For validity of the study, the results will be compared to patients~     that receive optimal medical therapy.~   "
141188|NCT01719250|"~     This pilot clinical trial studies how well buparlisib works in treating patients with~     non-Hodgkin lymphoma that has returned after a period of improvement or has not responded to~     previous treatment. Buparlisib may stop the growth of cancer cells by blocking some of the~     enzymes needed for cell growth.~   "
141189|NCT01719237|"~     A double blinded randomized controlled trial comparing the onset and duration of the Onset~     and Duration of Ultrasound Guided Supraclavicular Nerve Blocks Using a long acting local~     anesthestic (Ropivacaine) with a mixture of a long and short acting local anesthestic~     (Ropivacaine-Chloroprocaine Mixture).~   "
141190|NCT01719224|"~     The investigators hypothesized that sleeping in a 45 degrees elevated body position decreases~     the likelihood of upper airway vulnerability to collapse early after delivery. Furthermore,~     the investigators want to elucidate the anatomical and physiological risk factors that~     contribute in the upper airway obstruction in post-partum patients.~   "
141207|NCT01719003|"~     This study will investigate the efficacy and safety of two doses (high and low) of~     empagliflozin in combination with metformin (500 mg and 1000 mg) administered twice daily in~     patients with type 2 diabetes mellitus (T2DM). Study will compare four dose combinations of~     empagliflozin + metformin versus each individual component after 24 weeks of treatment.~   "
141191|NCT01719211|"~     The investigators have successfully identified two novel genetic loci for MVP on chromosomes~     11 and 13 and are searching for altered genes in these regions. This requires recruiting~     large families who may have MVP linked to these or other chromosomes; and obtaining DNA~     samples from 1,000-1,500 individually affected patients to study the relation between DNA~     markers throughout the genome and MVP. It is our expectation that the results of this study~     will lead to the discovery of gene(s) responsible for MVP. This will lead to improved~     understanding of the disease and, in turn, improved ability to treat and prevent progression~     in genetically susceptible individuals.~   "
141192|NCT01719198|"~     The fecal calprotectin assay is used widely for inflammatory bowel disease diagnosis and the~     assessment of the disease activity. Some adenoma patients have elevated fecal calprotectin~     level, which could mean the role of fecal calprotectin as a screening marker for colon~     adenoma. We will investigate the usefulness of fecal calprotectin as colon adenoma marker for~     screening in this study.~   "
141193|NCT01719185|"~     This is a pilot study designed to test the hypothesis that the combination of phentermine and~     B12 will result in significantly greater weight loss among obese patients compared to~     phentermine alone.~   "
141194|NCT01719172|"~     The objective of this study is to determine the safety of Veriset™ Hemostatic Patch when used~     during non-emergent, open, soft tissue surgery where a topical hemostatic agent would be~     used.~   "
141195|NCT01719159|"~     This is a is a small scale open phase two interventional study to assess long-term~     stabilising effects of on neurological symptoms by regular intrathecal administered~     monoclonal antibodies in progressive multiple sclerosis.~   "
141196|NCT01719146|"~     The purpose of this study is to prospectively collect data on doses of Erythropoietic~     Stimulating Agents and Intravenous Iron, and the markers of erythropoietic activity and iron~     status. These data will be used to derive mathematical models which will subsequently guide~     dosing of both agents, such that a desired therapeutic outcome is achieved in every patient,~     while minimizing patient exposure to both agents.~   "
141197|NCT01719133|"~     Assessment of skin reactivity by skin prick tests to synthetic peptides derived from the~     major birch allergen bet v 1, in subjects allergic to birch pollen.~   "
141198|NCT01719120|"~     The aim of this study is to develop an Internet-based self-help therapy program for insomnia~     in Chinese language, and to conduct a randomized waiting-list controlled trial on the~     efficacy of Internet-based self-help therapy for insomnia.~   "
141199|NCT01719107|"~     The aim of the study is to investigate the effect of L. reuteri DSM 17938 on pain frequency~     and severity in children of 5-16 years old and with diagnosis of FAP.~   "
141200|NCT01719094|"~     Cardiovascular events are the leading non-cancer cause of mortality after childhood cancer,~     occurring at a significantly younger age than in the general population. The increased~     incidence of cardiovascular events adversely impacts the functional capacity, morbidity, and~     mortality of otherwise relatively healthy 20 to 40 year old individuals. Moreover,~     understanding of the mechanisms by which cancer treatment could influence the occurrence of~     latent cardiovascular events is unavailable. Our group and others have established~     independent, noninvasive magnetic resonance imaging (MRI) measures of cardiovascular risk in~     middle aged and elderly individuals. Cardiovascular risk include, acute coronary syndromes,~     cardiac death, and congestive heart failure. The goal of this application is to show that~     childhood cancer survivors at risk for impaired cardiovascular and cerebrovascular health~     have increased aortic stiffness, when compared to healthy adolescent and young adult age~     mate. Studies are designed to determine if MRI measures of cardiovascular function differ~     between adolescent/adult childhood cancer survivors (n=60), age matched controls (n=30), and~     adolescents/young adults with planned treatment with chemo- and radiation therapy (n=25). The~     investigators propose that MRI markers responsible for cardiovascular events represent new~     clinical indicators that could be targeted to treat asymptomatic cardiovascular diseases.~   "
141201|NCT01719081|"~     This project involves the assessment of the efficacy of two different image guided techniques~     in patients with low back pain due to arthritis of the sacroiliac joint (SIJ).~     Intra-articular injection of local anesthetics and steroids is performed to relieve pain~     originating from the SIJ. Fluoroscopy has been used traditionally for image guidance for this~     procedure but there is a growing interest in use of ultrasound (US) for this procedure. US~     avoids radiation exposure to the patient and the health care team (HCT) and is less~     expensive. We aim to compare procedural efficacy related outcomes for SIJ injections~     performed using these image-guided modalities.~   "
141202|NCT01719068|"~     This is a pilot study that aims to develop a lung cancer screening program for workers in~     British Columbia, Canada exposed to asbestos who are at risk of developing lung~     cancer/pleural mesothelioma. This is high risk population is at of respiratory system~     diseases as a result of their occupational exposures. Additionally, knowledge garnered from~     this study will allow us to develop other studies that will further our understanding of~     asbestos related lung cancer and mesothelioma.~   "
141203|NCT01719055|"~     To compile characteristics of real-world clinical outcomes for Boston Scientific commercially~     approved neurostimulation systems for pain in routine clinical practice, when used according~     to the applicable Directions for Use~      - and -~      To evaluate the economic value and technical performance of Boston Scientific commercially~     approved neurostimulation systems for pain in routine clinical practice~   "
141204|NCT01719042|"~     The purpose of this study is to improve tolerance of treatment of pulmonary Mycobacterium~     avium Complex disease via the use of therapeutic drug monitoring and the addition of~     anti-nausea medication or dietary supplements to the patients' daily drug regimen. The aims~     of this study are to use (1) Zofran® (Ondansetron 8mg), an anti-nausea medication or (2) a~     dietary supplement to decrease medication related gastrointestinal side effects of~     medications used to treat Mycobacterium avium Complex.~   "
141205|NCT01719029|"~     A better understanding of the optimal diet for women with gestational diabetes is fundamental~     to the management of this rapidly growing problem in pregnancy. Careful comparison studies of~     the current low- carbohydrate, higher-fat diet versus a diet higher in complex carbohydrate~     but lower in fat is critical in order to determine which diet results in a more favorable~     maternal 24-hour glucose, lipid, and inflammatory profile, all of which directly effect~     optimal fetal growth and may influence the future health of the offspring.~   "
141208|NCT01718990|"~     Drug discovery can take many years especially since most studies to measure effectiveness~     depend on clinical outcomes like pulmonary function tests and hospitalizations.~      This is an observational study designed to collect information, blood, and bronchoalveolar~     lavage fluid in people who have IPF and those who do not. The people who have IPF will be~     followed for 12 months to collect more biological samples and record clinically relevant~     information.~      The goal of this study is to identify new molecular markers that are measurable and reliable~     in people who have IPF. It is hoped that these markers can be used in future drug studies to~     significantly speed up the process of finding drugs that help.~   "
141209|NCT01718977|"~     This study aims to determine whether body weight-supported treadmill training (BWSTT) has~     beneficial effects, over and above arm-cycle ergometry training (ACET) on indicators of~     cardiovascular disease (CVD) risk in individuals with severe spinal cord injury (SCI).~      After SCI, the primary cause of illness and death is CVD. Currently, preventative measures~     focus around increasing physical activity- especially through the use of ACET. However,~     ACET's capacity to improve cardiovascular health is questionable. Research has demonstrated~     that BWSTT, an alternative form of exercise, may be capable of improving cardiovascular~     health in individuals with SCI.~      The studies primary outcome measure is carotid-to-femoral pulse wave velocity (cfPWV) which~     has been shown to have prognostic value for CVD above and beyond that of other risk factors.~     It is hypothesised that through large muscle mass involvement and postural challenge, the~     physical stimuli of BWSTT will reduce cfPWV and lower CVD risk in individuals with SCI.~   "
141210|NCT01718964|"~     To investigate the effects of cortisol on heroin craving and stress reaction in heroin~     addicted subjects Randomized, double-blind, placebo-controlled, cross-over, single~     administration of study medication Study hypothesis:Cortisol has an inhibiting effect on~     heroin craving and stress reactivity in opioid dependent subjects.~   "
141211|NCT01718951|"~     To compare the efficacy of golimumab with pamidronate in the treatment of axial~     spondyloarthropathy~   "
141212|NCT01718938|"~     This is a multicenter, randomized, double-blind, incomplete block, three period fixed~     sequence crossover, multicenter, placebo-controlled study. The study will assess three oral~     doses of velusetrag (5 mg, 15 mg, and/or 30 mg) or placebo, administered once daily in three~     periods of 1-week duration each, with a 1-week washout period between treatment periods, in~     subjects with diabetic or idiopathic gastroparesis.~      Study 0093 will evaluate the effect of velusetrag in subjects with diabetic or idiopathic~     gastroparesis by assessing changes in gastric emptying.~   "
141213|NCT01718925|"~     The burden of chronic disease is continuing to rise. Even though patients may be in remission~     or have quiescent disease, several studies have confirmed that symptoms, such as e.g.,~     fatigue, is troublesome.~      The primary aim of this study is to investigate whether or not there might be an association~     between levels of vitamin D and the subjective experience of fatigue in conditions, such as~     inflammatory bowel disease, diabetes mellitus, rheumatoid arthritis and irritable bowel~     syndrome.~      Secondary aims is to study both the co-occurence and influence of pain, depression and~     anxiety.~   "
141214|NCT01718912|"~     Many physically handicapped patients at the dental department, Toronto Rehabilitation~     Institute(TRI) have considerable gingival inflammation and breath odour because of the~     inability to effectively handle a toothbrush. These patients have considerable periodontal~     disease. There is a concern that these pathogens may have a detrimental effect on wound~     healing in other areas of the body.~      Hypothesis: Patients attending the dental department at TRI that are treated with the~     antibiotic-antifungal rinse containing metronidazole and nystatin will show substantial~     decrease in periodontal disease as measured by bleeding points and pocket depth when compared~     to the group that continues to use their regular oral hygiene methods (control group).~   "
141215|NCT01718899|"~     The purpose of this study is to determine the safety and tolerability of PVX-410, (a cancer~     vaccine), treatment regimen for patients with smoldering multiple myeloma as a single agent~     and in combination with lenalidomide.~   "
141216|NCT01718886|"~     The objective of this study is to evaluate the initial safety and preliminary effectiveness~     of the Obalon intragastric balloon system in European subjects with a BMI in the range of 27~     - 35 kg/m^2~   "
141217|NCT01718873|"~     The purpose of this study is to evaluate if giving bevacizumab prior to chemotherapy compared~     to giving bevacizumab at the same time as chemotherapy improves patient overall response to~     treatment.~   "
141218|NCT01718860|"~     This is a secondary analysis of a previously performed prospective, observer-blinded,~     observational study at Massachusetts General Hospital. The primary aim of this study is to~     evaluate the effects of residual paralysis at admission to the post-anesthesia care unit~     (PACU) on total costs of hospital care.~      Secondary analyses will be conducted to evaluate the effects of postoperative residual~     paralysis on potential cost-influencing factors, i.e. incidence of minor and major~     postoperative respiratory complications, hospital length of stay (LOS), unplanned intensive~     care unit (ICU) admission rate, as well as length of stay in the PACU.~   "
141219|NCT01718847|"~     The purpose of this open-label, single-arm, multi-center phase II trial is to evaluate the~     efficacy and safety of novel pan-HER inhibitor, NOV120101 (Poziotinib), as a 2nd line~     monotherapy agent in lung adenocarcinoma patients with acquired resistance to prior EGFR~     tyrosine kinase inhibitors (TKIs).~   "
141228|NCT01718730|"~     The purpose of this study is to learn if measures of brain activity are different in children~     and adolescents with depression who are in different stages of treatment. This is important~     because it may identify a biological marker for depression that could one day be used to~     identify depressed children who would benefit from certain treatments (medications for~     example), or to monitor how well treatments are working. Brain activity measures(known as~     cortical excitability and inhibition) will be collected by Transcranial Magnetic Stimulation~     (TMS). TMS is a noninvasive (no surgery or implants) brain stimulation technology which can~     make parts of the brain work without putting any wires or chemicals into the body.~     Measurements will take place over one 3-hour visit. This study does not provide any form of~     treatment.~      *There is an optional portion of the study that uses a brain scan to gather measures of brain~     structure and brain chemicals. The brain scan is called magnetic resonance and spectroscopy~     (MRI/MRS). MRI/MRS uses magnetic fields to study the structure of the brain and brain~     chemicals. The PI will determine eligibility for the MRI/MRS portion of the study.~   "
141220|NCT01718834|"~     Description: A randomized Placebo-controlled study to evaluate safety and efficacy of Cenv3~     peptide vaccine in normal volunteers. This study is designed to test safety of 3 consecutive~     monthly escalating doses of the immunogen ( 0.324 mg, 0.648 and 3.240 mg / 70 kgm body~     weight) in 40 healthy male subjects (15,15 and10 subjects respectively) plus 10 subjects on~     placebo. Bioavailability of Cenv3 will be tested throughout the duration of the experiment.~     In the study hyperimmune state will be achieved via 3 subcutaneous injections (0.648 mg~     each), once every 4 weeks. A placebo treated healthy subjects ( n= 10) will serve as~     controls. Chronic HCV patients ( n=50) who did not respond to IFN + RBV combined therapy will~     be recruited to test therapeutic efficacy of the compound via 6 consecutive injections (~     0.648 mg each ) every 2 weeks. ( NB : this group of patients has been already recruited in~     the first part of this project where evaluation of the compound is currently underway).~     Immunized healthy volunteers will be followed for a year compared with placebo group, where~     all biochemical, hematological, immunological and allergic parameters are recorded. Treated~     CHC patients will be evaluated for virological, hematological, biochemical and immunological~     states at the end of treatment.~      Subject : Cenv3 potential prophylactic and therapeutic immunogens in healthy volunteers and~     against chronic HCV infection respectively.~   "
141221|NCT01718821|"~     Pain is one of the most common symptoms associated with cancer. The approach to pain~     management compresses routine pain assessments, utilizes both pharmacologic and~     nonpharmacologic interventions, and requires ongoing reevaluation of the patient. Cancer pain~     can be well controlled in the vast majority of patients if the algorithms of pain control are~     systematically applied, carefully monitored, and tailored to the needs of the individual~     patient.This study is aimed to assess the current pain managements in upper gastrointestinal~     cancer patients in Taiwan. The effects of neuropathic pain and depression on the enrolled~     patients would also be assessed.~   "
141222|NCT01718808|"~     OBJECTIVE: The objective of the trial is to judge on the benefit obtained by an upfront~     cetuximab treatment delivered as monotherapy or as part of a combination treatment with~     capecitabine in vulnerable elderly patients selected for V-Ki-ras2 Kirsten rat sarcoma viral~     oncogene homolog (KRAS) wild-type and B-type Raf kinase (BRAF) wild-type metastatic~     colorectal cancer (mCRC).~   "
141223|NCT01718795|"~     During CPR bag-valve mask ventilation is difficult for basically skilled rescuers.~     Ventilation may be inefficient or with too high pressures result in stomach inflation and~     aspiration. Studies suggest that with a supraglottic airway device, such as the laryngeal~     tube, a basically skilled rescuer may ventilate more efficient and also safer. No prehospital~     study has been conducted comparing laryngeal tube and bag-valve mask ventilation during CPR.~     Thus, this study intends to compare ventilation with laryngeal tube and bag-valve mask~     performed by paramedics during CPR.~   "
141224|NCT01718782|"~     The purpose of this study is determine safety and efficiency of mechanical ventilation in~     children with two different types of single use laryngeal masks (Ambu AuraOnce vs. LMA~     Supreme). The main interest is leakage pressure of oropharynx and stomach. The null~     hypothesis is that leakage pressures of Ambu AuraOnce and LMA Supreme are equivalent. The~     alternative hypothesis is that there is a difference in leakage pressure.~   "
141225|NCT01718769|"~     Background: Insufficient nutritional intake, with or without concomitant morbidity, leads to~     weight loss or insufficient weight gain, is related to an increase in morbidity and mortality~     and exposes the child to medical complications. In addition, obesity is also related to~     complications during hospitalization and complications in general, and therefore early~     identification of these children is extremely important. Studies show that malnutrition is~     frequent among children upon hospitalization, where the risk of pediatric nutritional~     deterioration increases, even in the presence of mild stress factors. This risk is frequent~     mainly among children that arrive at the hospital with an initial poor nutritional status.~     Improving the nutritional status as part of the standard of care already at the ambulatory~     setting might improve the prognosis of children when ill. In Israel, nutritional screening in~     not conducted among children since there is no proper validated screening tool. Study~     objectives: To test the accuracy of the STAMP Screening Tool for pediatric nutritional risk~     which is designed to be used by nurses, and to compare it to a complete nutritional~     assessment conducted by a dietician in Clalit Health Care Services clinics. In addition, the~     investigators wish to examine the effects of using a screening tool for nutritional risk on~     the medical staff's attention to the nutritional status; this is measured by the collection~     of nutritional status-related data and their recording in the patient file.~      Methods: 100 boys and girls aged 1 to 6, attending Clalit Health Care Services Pediatric~     Centers, will undergo an assessment using the STAMP Tool; a questionnaire including 3~     questions with a summary score, according to which the nutritional risk level shall be~     determined. These children shall also undergo a complete dietician assessment in order to~     examine the validity of the STAMP Tool. In addition, 150 files shall be reviewed in the~     beginning of the research and after 6 months in order to estimate the change in medical~     staff's attention to nutritional status, by way of noting relevant diagnoses, reference to~     nutritional status- related tests and recording of anthropometric measurements.~      A statistical analysis to examine the validity of the STAMP Tool shall be carried out using~     the kappa test (K) (30). The effect of the STAMP Tool use shall be calculated using the chi~     square test.~   "
141226|NCT01718756|"~     Perioperative continuous infusion of lornoxicam would be an effective and safe regimen to~     reduce the patient controlled morphine consumption after orthopaedic surgery.~      After ethical approval, 96 patients scheduled for elective orthopaedic fracture surgery under~     general anaesthesia were randomly allocated to receive placebo, 12-hourly iv lornoxicam 16 mg~     or lornoxicam 16 mg followed with continuous infusion of 1.3 mg/hr., for 48 hours after~     surgery (n=32 per group). Anaesthesia was induced with propofol, sufentanil and rocuronium,~     and was maintained with 0.5-1 minimum alveolar concentration sevoflurane, sufentanil and~     rocuronium. Postoperative patient controlled morphine analgesia was used. Changes in heart~     rate, mean blood pressure and sevoflurane minimum alveolar concentration, visual analogue~     pain scores, and cumulative patient controlled morphine consumptions and blood loss for 48~     hours, platelet functions, bone non-union and the presence of adverse effects were recorded.~   "
141227|NCT01718743|"~     The goal of this clinical research study is to learn if the combination of MLN9708 and~     Revlimid (also called lenalidomide or CC-5013) can help to control MM as maintenance~     treatment after an autologous stem cell transplant.~      Lenalidomide is designed to change the body's immune system. It may also interfere with the~     development of tiny blood vessels that help support tumor growth. This may decrease or~     prevent the growth of cancer cells.~      MLN9708 is designed to block a protein that plays a role in cell function and growth. This~     may cause cancer cells to die.~   "
141229|NCT01718717|"~     Thoracic epidural anesthesia and analgesia for patients undergoing lung resection can reduce~     the occurrence of AF if it is continued for six postoperative days instead of just three.~   "
141230|NCT01718704|"~     The purpose of this study is to evaluate whether using penile vibratory stimulation with the~     Viberect handheld device can help the recovery of erections and urinary control after radical~     prostatectomy.~   "
141231|NCT01718691|"~     The purpose of this study is to assess the efficacy and safety of SyB L-0501 (two-day~     consecutive 90 mg/m2/day IV drip infusions) in combination with rituximab (375 mg/m2 IV drip~     infusion) on untreated, low-grade B cell non-Hodgkin's lymphoma and mantle cell lymphoma~     where hematopoietic stem cell transplantation is not indicated.~   "
141232|NCT01718678|"~     The purpose of this study was to evaluate the efficacy and safety of Melatonin in treatment~     of fatigue and Quality of Life of MS patients.~   "
141233|NCT01718652|"~     The purpose of this study is to determine how a single dose of cyclosporin affects the~     pharmacokinetics (ie, how the body affects the drug) of multiple doses of canagliflozin~     (JNJ-28431754). The safety and tolerability of canagliflozin will also be assessed in healthy~     volunteers.~   "
141234|NCT01718639|"~     This study is a randomized, placebo-controlled, single-blind, three-way crossover clinical~     trial to evaluate safety and efficacy of IQP-LH-101 (tablet form and liquid form) in~     postprandial heartburn.~      The null hypothesis is that there is no difference between IQP-LH-101 and the placebo in~     terms of efficacy for postprandial heartburn treatment.~   "
141235|NCT01718626|"~     Stage 1:First line therapy Sequential therapy of S1+Docetaxel followed by S1 is superior to~     concomitant S1+Docetaxel in the safety and clinical efficiency.~      Stage 2:Second line therapy To explore the feasibility of single drug(S1) maintenance~     treatment for advanced gastric cancer.~   "
141236|NCT01718613|"~     Although arginine vasopressin has been used as an additional drug in refractory shock in~     worldwide clinical practice, there are no prospective studies using it as a first choice~     therapy in patients with cancer and septic shock.~      The aim of this study is assess if the use of arginine vasopressin would be more effective on~     treatment of septic shock in cancer patients than norepinephrine, decreasing the composite~     end point of mortality and organ failure in 28 days.~   "
141237|NCT01718600|"~     Microembolization is commonly associated with carotid artery stenting (CAS), but our~     understanding of subclinical microembolization is superficial. Through collaborative effects~     of multidisciplinary team-experts, novel approaches, and longitudinal evaluations, we hope to~     better understand the clinical significance and long-term cognitive effects of microemboli.~     This proposal may change our current clinical practice by providing a better outcome measure~     for carotid interventions and improving outcomes of CAS procedures through risk factor~     stratification. Our central hypothesis is that development of subclinical microemboli is~     associated with decline in cognitive function following CAS and that the risk of development~     of microemboli themselves is associated with patient- and procedure-related factors. We hope~     that this prospective study will help to clarify these important issues in the era of rapidly~     evolving percutaneous interventions.~   "
141238|NCT01718587|"~     The current treatment methods of liver cirrhosis are limited ,including antiviral~     therapy,supportive therapy and liver transplantation. Antiviral therapy and Supportive~     therapy especially the regularly intravenous infusions of plasma or albumin are combined in~     the clinical classical therapy treatment. In the other hand,umbilical cord mesenchyma stem~     cell with self and directed differentiation capacity can effectively rescue experimental~     liver failure and contribute to liver regeneration, which suggests the feasibility of stem~     cell transplantation therapy. In this study, the safety and efficacy of umbilical cord~     mesenchyma stem cell transplantation through interventional procedures and classical therapy~     in patients liver cirrhosis will be evaluated and compared.~   "
141239|NCT01718574|"~     The purpose of this study is to examine the efficacy of a self-help workbook in enhancing a~     sense of empowerment, coping, quality of life and reducing distress for patients with cancer.~   "
141240|NCT01718561|"~     In general anesthetic the patient is deprived of his awareness and ability to breathe. It is~     therefore one of the most important tasks in anesthesia to ensure the patient's airway and~     breathing. It has been shown both in Denmark and internationally that failed management of~     the patient's airway is the main anesthesia-related cause of death and brain damage.~     Therefore, it is very important and highly prioritized among anesthesia personal, to be able~     to identify patients with a difficult airway. The aim of The DIFFICAIR Trial is to reduce~     the incidence of UNEXPECTED difficult airway management by optimizing assessment of the~     patient's airway before anesthesia. There is an international consensus on the importance of~     proper identification of patients with a difficult airway prior to anesthesia. Enabling~     optimal preparation and thus reducing mortality and complications. The DIFFICAIR Trial is a~     nationwide multicentre trial with approx. 70,000 patients. 28 of the country's anesthesia~     departments is randomized either to airway assessment based on the physicians' clinical~     judgment (current practice) or to use an objective risk score for airway evaluations~     including anatomical conditions known to be associated with difficult airway management. Data~     from The Danish Anesthesia Database is used to compare the success rates of the two methods.~     We hope that by using a systematic airway assessment we may reduce the number of unexpected~     difficult airway managements and thereby reducing the associated complications and death.~     Based on data we will contribute to a national recommendation for airway assessment before~     anesthesia.~   "
141241|NCT01718548|"~     Cordyceps Sinensis (CS) and Lingzhi extracts have been used in Chinese Medicine for many~     years for treatment of a variety of conditions. The aim of this study is to evaluate the~     effects of oral ingestion of CS and Lingzhi extracts of a period of 28 days on~     cardiopulmonary fitness and cognitive functioning in young, healthy physical education~     students.~   "
141242|NCT01718535|"~     The Spartan FRX CYP2C19 Test System (hereafter referred to as the 'FRX System') is a~     qualitative in vitro diagnostic test for the identification of a patient's CYP2C19 *2, *3 and~     *17 genotypes from genomic DNA obtained from buccal swab samples. This study is purposed to~     demonstrate the concordance (positive and negative percent agreement) by comparing the~     Spartan FRX system against bi-directional DNA sequencing. The study will also evaluate the~     concordance between three different sample transport embodiments provided to laboratories for~     use in transporting the reagent tubes with collected buccal sample swab to the laboratory.~   "
141243|NCT01718522|"~     The purpose of this registry is to collect the real life data on Sensor Augmented pump~     therapy usage in type 1 DM patients treated with Medtronic Insulin pumps and countinuous~     glucose monitoring systems in Germany.~   "
141244|NCT01718509|"~     The primary objective of the study is to demonstrate the efficacy of SPD489 compared with~     placebo in adults (18 55 years of age inclusive) with moderate to severe Binge Eating~     Disorder at Visit 8 (Weeks 11 and 12) as measured by the number of binge days (defined as~     days during which at least 1 binge episode occurs) per week as assessed by clinical interview~     based on subject diary~   "
141245|NCT01718496|"~     The investigators are studying the effect of a single dose Opioid drug (Morphine) on dyspnea~     and exercise tolerance in COPD patients.~   "
141246|NCT01718483|"~     The primary objective of the study is to demonstrate the efficacy of SPD489 compared with~     placebo in adults (18 55 years of age inclusive) with moderate to severe Binge Eating~     Disorder at Visit 8 (Weeks 11 and 12) as measured by the number of binge days (defined as~     days during which at least 1 binge episode occurs) per week as assessed by clinical interview~     based on subject diary~   "
141247|NCT01718470|"~     Extubation and emergence from anesthesia lead to systemic and cerebral hemodynamic changes~     that can cause cerebral edema and hemorrhage. The hemodynamic profile on emergence is more~     favorable if a laryngeal mask airway (LMA) is inserted before neurosurgical patients emerge~     from anesthesia. We aimed to compare the impact of awakening neurosurgery patients after~     insertion of a ProSeal LMA to replace the endotracheal tube (ETT).~   "
141248|NCT01718457|"~     Diabesity (Diabetes accompanied by obesity) is a prevalent condition many times complicated~     by micro- and macrovascular disease. Many treatments for Diabesity paradoxically cause~     further weight gain and hypoglycemia. The Endobarrier enables diabetes control along with~     weight loss as an alternative to bariatric surgery for patients who are not interested or not~     qualified for surgery. The aim of this study is to assess the efficacy and safety of the~     Endobarrier Diabesity patients in Israel.~      This study will include 45 men and women between the ages of 18-65 with HbA1c level of 8% and~     above and a BMI of 30 kg/m2 or above.~      Exclusion criteria: use of anti-coagulant, use of steroids or inability to discontinue these~     medications.~      The cohort will be followed for two years during which the patients will be monitored for~     diabetes control (by using a continuous glucose monitor), weight, blood pressure, lipid~     profile, fatty liver (by Ultrasound and blood markers for inflammation and fibrosis) and~     change in plasma gut peptide levels. The Endobarrier will be explanted after one year,~     however the monitoring of the patients will continue for another year.~   "
141249|NCT01718444|"~     Progestin-induced endometrial shedding (PIES) followed by clomiphene citrate is fertility~     treatment of choice in anovulatory women with polycystic ovary syndrome (PCOS). However, some~     preliminary data suggest that skipping PIES could result in a higher live birth rate. The~     investigators are performing the first randomized controlled trial to find out if skipping~     the use of progestin during fertility treatment of anovulatory PCOS women is associated with~     improved pregnancy and live birth rates compared to the traditional approach of using~     progestin prior to use of clomiphene citrate.~   "
141250|NCT01718431|"~     This study aims at investigating the impact of colonic fermentation of intrinsic indigestible~     carbohydrates in cereal whole kernels after three days consumption, on metabolic variables~     and cognition. The study is performed in healthy, normal to slightly over-weight test~     subjects.~   "
141251|NCT01718418|"~     The purpose of the study is to evaluate food factors related to colonically derived~     regulation of glucose metabolism (and related parameters) and satiety using a semi-acute meal~     study in healthy subjects as experimental model.~   "
141252|NCT01718405|"~     Studies have shown that an acute bout of aerobic exercise positively effects cognition,~     mainly executive functioning; however the effect is not observed among all people and it is~     not clear whether only aerobic exercise can produce this effect or possibly also resistant~     exercise. The main purpose of our study is to examine whether genetic variation is a~     moderator of this effect and whether resistant exercise is comparable to aerobic exercise in~     improving cognition following a single bout of exercise.~   "
141253|NCT01718392|"~     the purpose of this study is to investigate the development of insulin resistance in multiple~     sclerosis patients + explaining the effects of a combined training programme on insulin~     resistance, muscle power and aerobic capacity in multiple sclerosis patients~   "
141254|NCT01718379|"~     The goal of the present study is to assess, through a randomized phase II trial, the efficacy~     and safety of Lenalidomide with or without Epoetin beta in transfusion-dependent,~     ESA-resistant, IPSS low and intermediate-1 risk MDS patients without chromosome 5~     abnormality.~      Patients will receive either Lenalidomide alone or Lenalidomide and Epoetin beta for 4~     months. Responders will be eligible for maintenance treatment with cycles identical to the~     first cycles, until relapse occurs or until unacceptable toxicity.~   "
141255|NCT01718366|"~     Determinate safety and response rate of the association Deferasirox -Vitamine D - Azacitidine~     in treatment of high risk MDS~      Deferasirox Exjade:~      The dose of Deferasirox will be assigned according to the ferritin level. Dose escalation is~     scheduled during the phase I, with 5 additional patients per group.~      The maximal tolerated dose of Deferasirox will be required for the phase II of the study.~      The first dose will be assigned according to the ferritin level of the patient at time of~     inclusion:~      5 mg/kg/d if the ferritin is >300ng/ml and < 1000ng/ml in Group 1 10 mg/kg/d if the ferritin~     is ≥1000ng/ml) in Group 2~      Group 1 : Ferritin 300 to 1000ng /ml:~        -  cohort 1 : 5 mg/kg/d~        -  cohort 2 : 10mg/kg/d~        -  cohort 3 : 15 mg/kg/d~      Group 2 : Ferritin > 1000ng /ml:~        -  cohort 1 : 10 mg/kg/d~        -  cohort 2 : 15mg/kg/d~        -  cohort 3 : 20 mg/kg/d~           5 patients will be treated by cohort. In absence of toxicity (extra-hematological~          toxicity grade 3 or 4 or hematological grade 4), 5 additional patients will be included~          in the next cohort.~      Deferasirox will be administrated once daily during all the study period. Uvedose will be~     administrated once weekly during all the study period (100.000 UI P.O).~      Azacitidine will be administrated sc at 75 mg/m²/d, during 7 days, J1 to J7 of each~     cycles(One cycle is 28 days)~      During phase I and II, Deferasirox will always be associated with Vitamin D and Azacitidine~      Patients will be received 6 cycles of treatment (except if progression, unacceptable toxicity~     or withdrawn of patients occured) After 3 and 6 cycles, an evaluation will be done to~     evaluate the efficacy of the treatment.~      No dose modification of deferasirox will be done after 3 cycles of treatment except in case~     of progression). After 6 cycles, patients with CR, PR, marrow CR or HI will be treated with~     the same dose of Deferasirox until progression .~   "
141270|NCT01718171|"~     Although the presence of SIRS has been described in patients with appendicitis, its~     progressive response related and together with progression of symptomatology from the onset~     of symptoms to diagnostic has not been characterized. Continuation of the systemic~     inflammation in patients with injury and infectious processes may result in multiple organ~     dysfunction and ultimately failure. As with any acute inflammatory condition, the patients'~     systemic inflammatory response to appendicitis will progress and become more intense with the~     passing of time. The purpose of this study is to characterize the systemic inflammatory~     response to appendicitis from the beginning of symptoms to diagnostic in patients with~     appendicitis submitted to emergency surgery.~   "
141256|NCT01718353|"~     Docetaxel and cabazitaxel are cancer chemotherapy agents of the taxane drug class. The~     purpose of this study is to explore the benefit, for treatment of metastatic~     castration-resistant prostate cancer (mCRPC), of a regimen in which participants begin~     treatment with either of these two taxane drugs (docetaxel or cabazitaxel, in combination~     with prednisone) and are switched to the other taxane drug if prostate-specific antigen (PSA)~     value does not decrease ≥30% after 4 cycles. As defined in study protocol amendment 3,~     efficacy results are summarized for all participants combined, irrespective of which agent~     (docetaxel or cabazitaxel) was administered initially, rather than separately for the two~     groups based on taxane administered initially. One of the primary outcome measures is~     percentage of participants with a ≥50% sustained decrease from baseline in PSA at any time~     during the trial. By providing an opportunity for patients to switch taxane based on early~     PSA response, there may be a difference in result for this measure versus result in a study~     where it was not possible to switch. The other primary outcome measures are change from~     baseline in circulating tumor cells (CTCs) biomarkers percent androgen receptor nuclear~     localization (%ARNL) and microtubule bundling (MTB).~   "
141257|NCT01718340|"~     The prevalence of insulin resistance is increased in women with recurrent miscarriage~     compared with matched fertile controls,Insulin resistance (IR) in this syndrome is not only~     implicated toward early pregnancy loss (EPL) but also pathognomic for various obstetrical~     complications during pregnancy.An elevated free androgen index appears to be a prognostic~     factor for a subsequent miscarriage in women with recurrent miscarriage.~      There is insufficient evidence to evaluate the effect of metformin supplementation in~     pregnancy to prevent a miscarriage in women with recurrent miscarriage.~   "
141258|NCT01718327|"~     For patients with non-resectable cholangiocarcinoma, gemcitabine with cisplatin is considered~     as the reference treatment in first line chemotherapy. However, the outcomes of these~     patients remain limited and therefore more effective drugs are warranted. The context of the~     disease and current data on sunitinib suggest that sunitinib may have activity in patients~     with advanced non resectable cholangiocarcinoma.~      Thereby, it is proposed to conduct an open label single arm trial aiming evidencing activity~     of sunitinib in such a patient population.~   "
141259|NCT01718314|"~     Hysteroscopy is an instrument to visualize the interior walls of uterus (womb) and it enables~     the doctor to do minor operative procedures. Although it causes little discomfort, sometimes~     it may be disturbing for the patient. This pain is usually perceived during the passage of~     the instrument through the cervix (neck of the womb). The investigators would like to~     minimize this pain by two drugs: Misoprotol and lidocaine~   "
141260|NCT01718301|"~     The primary objective of this study is to evaluate the safety and efficacy of a Response~     Guided Therapy of boceprevir 800 mg dosed three times a day (TID) orally (PO) in combination~     with Peginterferon (either alpha 2b or alpha 2a) and Ribavirin in HIV/HCV genotype 1 infected~     patients that failed to previous HCV therapy.~   "
141261|NCT01718288|"~     Evaluate the possibility of optimization of therapy with prostanoids (iloprost), in patients~     with Fontaine's stage IIb severe chronic ischemia, both in patients eligible for surgery both~     in patients for which it is only possible medical therapy~   "
141262|NCT01718275|"~     The purpose of this study is to determine the feasibility of non-operative management of~     early appendicitis in children. We hypothesize that non-operative management of early~     appendicitis in children with antibiotics alone will be successful in 80% of children at 1~     year follow-up.~   "
141263|NCT01718262|"~     The purpose of the study is to measure the blood levels of the medicine called ropivacaine~     (local anesthetic) used to manage pain. Ropivacaine is a widely used medication and is not~     the subject of this study, but the investigators are studying how much of the drug can be~     found in the patient's blood, known as the blood level, of this medicine. Too much~     ropivacaine in a patient's blood can lead to local anesthetic toxicity. Once the nerve~     catheter is removed, local anesthetic toxicity is no longer a potential problem. However,~     there is little data on what ropivacaine blood levels are after having the catheter in for a~     long period of time(up to one month).~   "
141264|NCT01718249|"~     Chronic post-coma consciousness impairment is a severe handicap. Preliminary studies suggest~     that deep brain stimulation of the thalamic-tegmental reticular system could improve~     consciousness disorders, and facilitate the emergence of conscious behavior. The aim of this~     protocol is to study the effects of deep brain stimulation on conscious behavior, using a~     patient-based anatomic mapping for stereotactic surgery, and the Coma Recovery Scale-Revised~     (CRS-R) as clinical assessment criterion.~   "
141265|NCT01718236|"~     The project aims to introduce into clinical practice for Caesarean section conducted under~     general anesthesia with the rapid induction myorelaxation with rocuronium and the reversal of~     neuromuscular blockade by using sugammadex. The aim is to demonstrate at least the same~     efficiency and confirm the safety of the procedure for both mother and newborn compared with~     older procedure.~   "
141266|NCT01718223|"~     This pilot clinical trial studies photodynamic therapy using temoporfin before surgery in~     treating patients with recurrent oral cavity or oropharyngeal cancer. Photodynamic therapy~     uses a drug, such as temoporfin, that is absorbed by tumor cells. The drug becomes active~     when it is exposed to light. When the drug is active, tumor cells are killed. Giving~     photodynamic therapy using temoporfin before surgery may make the tumor smaller and reduce~     the amount of normal tissue that needs to be removed.~   "
141267|NCT01718210|"~     The purpose of this study is to determine whether in Assisted Reproductive Technologies the~     use of culture medium supplemented with GM-CSF, a growth factor working on stem cells, may~     improve the embryo implantation in patients experiencing recurrent implantation failure in~     IVF cycles.~   "
141268|NCT01718197|"~     The mission of SARP is to improve the understanding of severe asthma through integrated study~     of its clinical and biological features and to evaluate their changes over time. The ultimate~     goal of these efforts is to promote better treatments for severe asthma.~   "
141269|NCT01718184|"~     A prospective study to evaluate the safety and efficacy of a piggyback sulcoflex toric~     intraocular lens in pseudophakic patients for correcting refractive errors following corneal~     transplantation~   "
141281|NCT01718028|"~     The purpose of this study was to evaluate the ability of SYSTANE® BALANCE dosed 4 times a day~     for 30 days to increase non-invasive tear film break up time over baseline, compared to a~     saline control, in dry eye subjects with lipid deficiency.~   "
141271|NCT01718158|"~     The purpose of this study is to determine if treatment with Pegylated Interferon Lambda-1a,~     given in combination with Ribavirin and Daclatasvir for 24 weeks, is as safe and effective as~     the standard treatment with Pegylated Interferon Alfa-2a + Ribavirin + Telaprevir in subjects~     who are infected with Chronic Hepatitis C virus genotype 1b and have never received any prior~     anti-HCV treatment, or who have relapsed after an initial, successful treatment with~     Pegylated Interferon Alfa + Ribavirin~   "
141272|NCT01718145|"~     The purpose of this study is to assess the anti-viral activity of BMS-790052 and BMS-650032~     combination therapy in Japanese subject.~      The purpose of this study is to compare the anti-viral activity of the co-administration of~     Asunaprevir (ASV) and Daclatasvir (DCV) to Telaprevir (TVR) included therapy in Japanese~     Hepatitis C virus (HCV) subjects~   "
141273|NCT01718132|"~     Aim of this prospective study was to assess the quality of postoperative care in a~     postoperative anaesthesia care unit (PACU) using postoperative pain, nausea and vomiting as~     well as their reduction as quality markers. So far, only sparse data related to this topic~     are available and there are currently no established quality markers of a PACU service.~   "
141274|NCT01718119|"~     The purpose of this study is to compare the efficacy and safety of DA-3803(r-hCG) and Ovidrel~     for inducting final follicular maturation and early luteinization in women undergoing~     ovulation induction for assisted reproduction treatment~   "
141275|NCT01718106|"~     Multiple overlapping drug-eluting coronary stents (DES) are usually needed to treat long~     coronary stenoses but this strategy is expensive and the response to overlapping DES has not~     been extensively studied. The recent availability of bioabsorbable polymer DES could allow~     treatment of long coronary stenoses without leaving gross burden of non-absorbable polymer in~     the vessel wall, even in case of overlapping stents.~      Thus we planned to evaluate which of the 2 strategies, namely using a single long~     biabsorbable DES or two shorter biabsorbable DES with minimal overlapping, is better in~     treating long coronary stenoses.~      The study is a spontanous randomized multicenter open-label study. A maximum of 300 patients~     with stable angina and at leat 1 coronary stenosis >28mm and <40mm of length will be~     randomized in 1:1 fashion by a Web-based electronic CRF. The long stent group (Group A) will~     be treated by a single 44mm Biomime DES (II generation DES with bioabsorbable polymer, Meril~     Life Sciences Pvt. Ltd., Gujarat, India). The short stent group (Group B) will be treated by~     2 short Biomime DES positioned with minimal overlapping. The primary end-point of the study~     will be the 6 moth in-stent late lumen loss. Seconadry end-points will be 1, 6 and 12 month~     overall mortality, myocardial infarction, target vessel revascularization, stent thrombosis~     and MACE (combination of the 3 previous clinical end-points). Patients will be evaluated by~     6-month control coronary angiography and late lumen loss in the stented vessel will be~     measured in a quantitative coronary angiography Core Lab (Cardioimaging Centre, Novara,~     Italy)~   "
141276|NCT01718093|"~     The purpose of this study is to see if the use of metformin and sitagliptin used in~     conjunction with insulin can improve the blood sugars of teenagers with Type 1 diabetes.~   "
141277|NCT01718080|"~     Our goal is to investigate how hormones that control blood sugar, hunger, and stomach~     emptying change with puberty and being overweight. These substances change with a meal.~        -  For this, we need to compare lean and overweight children.~        -  We need to study them before and during puberty.~        -  All children in the study will be tested before and after a liquid meal.~   "
141278|NCT01718067|"~     Mechanical devices to increase the individual's bronchial hygiene are commonly used to assist~     patients with chronic retention of secretions. VAKÜM technology has been recently developed~     with the aim to improve the respiratory condition in hypersecretive patients suffering from~     chronic respiratory diseases.~      The aim of this study is to assess the clinical efficacy of VAKÜM technology in patients with~     hypersecretion, and chronic respiratory diseases a clinical trial has been designed.~      Patients with chronic respiratory diseases, hypersecretion (sputum production >30 mL/die),~     and reduced cough efficiency (Peak Cough Expiratory Flow > 150 and < 300 L*min-1) referred to~     standard pulmonary rehabilitation (PR) will be included. Study design is a single-blind~     multicentre randomized trial with consecutive recruitment. Following a preliminary run-in~     period, group comparison will be made between Intervention group using VAKÜM system (Free~     Aspire, MPR, Legnano-I) added to the conventional manual ELTGOL technique, and Control group~     using manual ELTGOL alone over 10 daily sessions.~      Spirometric lung volumes, respiratory muscle strength, arterial blood gases, and quality of~     life will be recorded in both groups pre-to-post PR. Perceived dyspnea (by VAS scale), sputum~     volume and characteristics (on a semi-quantitative 3-point scale) and peak expiratory air~     flows (PEF and PCEF) will be registered on a daily basis over the study period. Primary~     outcome is the change in perceived dyspnea; in order to ensure 80% power to detect a 5 point~     (SD 5) group difference change in the primary outcome at the end of the study period as~     significant at the 0.05 level, at least 42 patients per group are needed. The minimum target~     sample size will be then fixed at 50 patients per group.~      An higher and faster significant reduction of the perceived dyspnea is supposed in the~     Intervention group. Additional benefits among the secondary outcomes are also hypothesised in~     the same group.~   "
141279|NCT01718054|"~     Sickle cell disease (SCD) is the most common inherited disorder worldwide affecting 300,000~     births annually, most occuring in sub-Saharan Africa (SSA) where poor detection and care~     result in high childhood mortality, malnutrition, illness and disability in survivors. SCD is~     caused by abnormal haemoglobin, the compound in red blood cells(RBC) that carries oxygen.~     Much of the disability in SCD may be caused by vascular damage from the breakdown of damaged~     RBC. Research in high-income countries has led to some effective therapies but these are~     currently costly and complex. The investigators will test two different formulations of an~     affordable, ready-to-use supplementary food (RUSF) specifically tailored for children with~     SCD. As well as containing energy, protein, essential fats, vitamins and minerals, the~     vascular RUSF (RUSFv) will be fortified with the amino-acids arginine and citrulline and be~     delivered with a daily chloroquine dose to create a novel nutraceutical intervention.~     Arginine is converted to nitric oxide which is essential for vascular health. Arginine levels~     are low in SCD because the arginine-degrading enzyme, arginase, is released from RBCs. The~     investigators propose that by supplying additional arginine (and citrulline which converts to~     arginine) and suppressing arginase activity (an action of chloroquine) the investigators can~     improve vascular function. Our study will test this theory, and if provision of RUSF improves~     growth in children with SCD.~   "
141280|NCT01718041|"~     This is a Phase 1b/2a study of VRS-317 (long-acting growth hormone) in pediatric patients~     with growth hormone deficiency. During Phase 1b, pediatric patients each will receive a~     single subcutaneous injection of VRS-317. During the Phase 2a stage, patients will receive 6~     months of VRS-317 treatment at dose levels selected from the Phase 1b stage. The primary~     endpoints for the study are to determine the safety and efficacy of repeat dose VRS-317.~   "
141282|NCT01718015|"~     Background: The pathogenetic factors underlying development of diabetic polyneuropathy (DP)~     remain unclear. Reduced neurotrophic stimulation has been proposed as a possible mechanism.~     The neurotrophic factors IGF I and II, sCD-163, NGF, VEGF and BDNF are essential for~     development and regeneration of the nervous system. In earlier studies reduced concentrations~     of IGF-I and II in blood and reduced concentrations of NGF and BDNF in muscle and skin~     biopsies have been found in patients with DP.~      Purpose: Our purpose is to determine the concentration and biological activity of~     Insulin-like Growth Factor I and II (IGF-I and II), soluble Cluster of Differentiation 163~     (sCD-163), Nerve Growth Factor (NGF), Vascular Endothelial Growth Factor (VEGF) and~     Brain-derived Neurotropic Factor (BDNF) in cerebrospinal fluid and in blood in patients with~     diabetes and/or nerve disease (especially diabetic polyneuropathy) as well as in healthy~     control subjects. We will furthermore relate the findings to peripheral nerve function. In~     addition the composition of the cerebrospinal fluid will be analyzed using mass spectrometry.~      Hypothesis: We hypothesize that DP develops due to reduced concentration and biological~     activity of neurotrophic factors. We expect the concentration of IGF-I and II, VEGF, NGF and~     BDNF to be reduced in cerebrospinal fluid in patients with DP compared to diabetic patients~     without damage to the nervous system and healthy control subjects.~      Methods: Study subjects consists of patients from Department of Neurology and Department of~     Department of Clinical Medicine (Endocrinology and Diabetes) Aarhus University Hospital,~     Denmark, who are having a lumbar puncture performed.~   "
141283|NCT01718002|"~     The care of the oral cavity is an important way to prevent local and systemic infections.~     This study aimed to: evaluate the use of video as a teaching strategy of oral hygiene for~     patients undergoing chemotherapy. The methodological design used was quasi-experimental~     before-after intervention. The sample consisted of 23 subjects who performed the technique of~     oral hygiene before and after watching an educational video. To do so was given a kit with a~     toothbrush with soft bristles, toothpaste with low abrasivity, mouthwash or product to~     mouthwash and dental floss for oral hygiene. For data analysis we applied the parametric test~     t Student paired.~   "
141284|NCT01717989|"~     To describe trends in treatment patterns of Small Dialysis Organizations (SDOs) prior to and~     during the implementation of the Centers for Medicare and Medicaid Services' (CMS') policy~     [End Stage Renal Disease (ESRD) Prospective Payment System (PPS)] to bundle reimbursement for~     all dialysis services. Specifically, to describe CMS ESRD PPS quality performance measures~     for dialysis centers over time.~   "
141285|NCT01717976|"~     The Veterans' Health Administration (VHA) is committed to improving primary care through the~     implementation of Patient Aligned Care Teams (PACTs). Improving access to services and care~     coordination are among the primary goals of PACTs; however, there remain many unanswered~     questions about how best to use the limited time of PACT team members, such as nurse care~     managers, to accomplish this. This study will evaluate the effectiveness of a nurse-led~     telephone support program for Veterans who have been treated recently in the emergency~     department (ED) and are at high risk for repeat visits. The program's goals are to reduce the~     need for future ED use and improve satisfaction among Veterans by providing information and~     support related to the ED visit, enhancing chronic disease management and educating Veterans~     and family members about PACT and other VA and community services. If proven effective, this~     program could improve health and healthcare for a large, vulnerable group of Veterans and be~     cost saving for VHA.~   "
141286|NCT01717963|"~     Persons dependent on opioids like heroin, morphine, or codeine have a high risk of relapse,~     overdose and overdose death. This risk is elevated even further following discharge from~     treatment or correctional institutions where patients have been detoxified. At the moment,~     state-of-the-art treatment is based on maintaining the dependence on opioids by daily intake~     of opioid medications like methadone or buprenorphine. Recently, a medication containing the~     blocking agent naltrexone was approved in the US; this does not maintain dependence but~     instead blocks heroin and other opioids for 28 days after intramuscular administration. This~     study will conduct a 12-week randomized comparison of naltrexone intramuscular suspension~     (XL-NTX) with daily buprenorphine-naloxone in OMT. Medication will start preceding discharge~     from a treatment or correctional facility to participating catchment regions in Norway. The~     main hypotheses are that XL-NTX will do equally well as - or better than - OMT on the~     proportion of biological samples negative for opioids, retention, self-reported use of~     alcohol and illicit drugs. Following the 12-week randomized period, there will be a 36-week~     period where participants can receive the study medication of their choice. After the end of~     the study, data from national registry databases can be collected for a further 12 months on~     outcomes such as recidivism, mortality and morbidity.~   "
141287|NCT01717950|"~     Hookworms digest hemoglobin from erythrocytes for use as an energy source via a proteolytic~     cascade that begins with the aspartic protease, APR-1. Vaccination with recombinant APR-1 has~     protected animals from infection in challenge studies. This study will evaluate the safety~     and immunogenicity of two formulations of Na-APR-1 (M74) in healthy adult volunteers when~     co-administered with different concentrations of the immunostimulant GLA-AF.~   "
141288|NCT01717937|"~     The purpose of this study is to determine whether phase variance optical coherence tomography~     (PV-OCT), a software-based optical coherence tomography(OCT) image processing technology, can~     be used to generate angiographic images of the retinochoroidal vasculature that are~     comparable to those produced by fluorescein angiography (FA), the current gold standard~     diagnostic test.~   "
141289|NCT01717924|"~     The ADCI 002 trial is a large multicenter phase II-III prospective randomized controlled~     trial comparing primary surgery versus primary chemotherapy followed by surgery in patients~     with a resectable signet ring cell gastric adenocarcinoma~   "
141300|NCT01717781|"~     This prospective randomized pilot study is aimed to verify if the operative time of a LRH~     with pelvic lymphadenectomy for early stage cervical cancer (FIGO stages IA2-IB1-IIA<2cm) and~     for advanced stage cervical cancer (FIGO stages IB2-IIA>2cm-IIB) submitted to neoadjuvant~     chemotherapy with complete clinical response could be reduced using Thunderbeat (an~     ultrasonic energy device that incises and coagulates by using ultrasonic and bipolar~     technology ) (Olympus Medical Systems Corp, Tokyo) vs. bipolar electrosurgery .~      Secondary endpoints of this comparison are incidence of intra- or postoperative~     complications, estimated blood loss, postoperative pain, days of hospitalization and costs~     for the health care system.~   "
141290|NCT01717911|"~     We have found that a 6-month course of insulin therapy after a short-term intensive insulin~     therapy could shorten the period of hyperglycemia to preserve ß-cell function and further~     improve long-term glycemic control in recently diagnosed type 2 diabetes with severe~     hyperglycemia (>300 mg/dl, with HBA1C level around 9-11%) in our previous study. We thus~     hypothesized that a 6-month course of basal insulin therapy could also help to preserve~     ß-cell function in newly diagnosed type 2 diabetes with moderate hyperglycemia (200-300~     mg/dl). This prospective study is outpatient-based to evaluate whether 6-month basal insulin~     therapy versus oral anti-diabetic treatment (Metformin and sitagliptin) soon after the~     diagnosis of type 2 diabetes with moderate hyperglycemia (200-300 mg/dl) is associated with~     better ß-cell function reservation. We skip a short-term intensive admission course of~     insulin therapy as our previous study in newly diagnosed type 2 diabetes with severe~     hyperglycemia.~   "
141291|NCT01717898|"~     There will be two parts to this clinical research study. The purpose of each part is:~        -  Phase 1: This part of the study will determine what dose of BEZ235 is safe to give with~          a standard dose of abiraterone acetate and prednisone by administering different doses~          of BEZ235. This will help to find out what effects, good and/or bad, this combination~          has on CRPC.~        -  Phase 2: This part of the study will measure the treatment effect of the combination of~          BEZ235 and abiraterone acetate/prednisone on CRPC.~   "
141292|NCT01717885|"~     The burden of malaria is greatest in children and pregnant women in sub-Saharan Africa.~     Malaria is one of the most important infectious diseases in the world. Uganda reports among~     the highest transmission intensities in the world. Children and pregnant women are the most~     vulnerable populations. HIV is also reported at high rates for these populations. If malaria~     and HIV require treatment at the same time, there is a high risk for drug-drug interactions.~     This study will:~        1. Determine if the use of anti-HIV medications including lopinavir/ritonavir (LPV/r),~          nevirapine (NVP) and efavirenz (EFV) will affect the pharmacokinetic (PK) exposure of~          antimalarial medications (specifically artemether-lumefantrine, AL) during the treatment~          for uncomplicated malaria in HIV-infected children and pregnant women, and~        2. Evaluate the impact of age and pregnancy on the PK exposure of AL.~   "
141293|NCT01717872|"~     To compare the laryngoscopy view using two standard clinical devices, the Macintosh and~     Miller laryngoscopy blades, in infants between one day and two years of age.~      Miller blades (straight blades) are more commonly used than MacIntosh blades (curved) in~     pediatric clinical practice in some institutions especially in infants. The anatomy of infant~     airway has traditionally been considered to lend itself to advantages of the Miller blade.~     Some argue that the Miller blade offers a superior view of the laryngeal inlet because it~     lifts the epiglottis. However, others use the Miller blade to expose the larynx without~     lifting the epiglottis, supposedly to avoid traumatizing it. Despite the long-standing use of~     these blades, more than 50 years, no systematic study has ever compared the laryngoscopy~     views of the Miller and Macintosh blades in infants.~   "
141294|NCT01717859|"~     The purpose of this research study is to determine if a change in inflammation or baseline~     inflammation seen on the ultrasound is a good indicator of how rheumatoid arthritis patients~     respond to TCZ 4mg/kg and whether early prediction of dose escalation is possible by~     utilizing ultrasound inflammatory measures.~   "
141295|NCT01717846|"~     This proposal will test the hypothesis that Orencia affects apoptosis and apoptosis related~     genes/biomarkers in vivo in rheumatoid arthritis (RA) patients.~   "
141296|NCT01717833|"~     The purpose of this study is to investigate the role of NEMS as a rehabilitation tool for~     muscle weakness following critical illness. The investigators hypothesized that NEMS combined~     with exercise rehabilitation will have a beneficial role in restoration of muscle strength~   "
141297|NCT01717820|"~     The purpose of the study is to provide whole-grape powder or a placebo as a supplement to~     postmenopausal women for 12 weeks to determine the effects on body composition and bone~     formation.It is hypothesized that 12 weeks of supplementation with whole-grape powder will~     decrease body fat via resveratrol's positive effects on metabolism and negative effects on~     fat cells.~   "
141298|NCT01717807|"~     The EGFR is one of the most frequently overexpressed proteins in various cancers including~     lung cancer, and is related to tumor progression and resistance to most treatments.~      New treatment strategies targeting EGFR have been developed: although much work remains to~     be done, erlotinib has already established itself as part of the therapeutic armamentarium~     against cancer(A review of erlotinib and its clinical use. Tang PA, Tsao MS, Moore MJ.~     Expert Opin Pharmacotherapy. 2006 Feb;7(2):177-93.)~      Noninvasive PET/CT imaging of EGFR expression activity and mutation status in NSCLC could aid~     in the selection of patients for individualized therapy with EGFR kinase inhibitors.~      Whole-body noninvasive PET/CT imaging could estimate treatment-responsive vs. -resistant~     tumor burden before the initiation of therapy with EGFR inhibitors.~      The purposes of the study are:~        1. To adjust an optimal treatment for patients with tumors that have high expression of~          EGFR by identification of this type of cancer using C11-Erlotinib PET/CT during~          pretreatment work-up; as well as to follow up after treatment response.~        2. To recognize patients with advanced pancreatic cancer responding to treatment with~          erlotinib and to distinguish them from non-responders.~   "
141299|NCT01717794|"~     This prospective randomized pilot study is aimed to verify if the operative time of a TLH~     with pelvic lymphadenectomy for endometrial cancer FIGO stage IB-II could be reduced using~     Thunderbeat (an ultrasonic energy device that incises and coagulates by using ultrasonic and~     bipolar technology ) (Olympus Medical Systems Corp, Tokyo) vs. bipolar electrosurgery .~      Secondary endpoints of this comparison are incidence of intra- or postoperative complications~     (Cardiac, Respiratory, Neurological, Gastrointestinal, Renal, Fever, Wound or other~     Infection, Lymphocele), estimated blood loss, postoperative pain (evaluated by VAS), days of~     hospitalization and costs for the health care system.~   "
141400|NCT01716481|"~     The objectives of this study was to test hypothesis that ischemic stroke patients having~     moderate to severe persistent neurologic deficit will have better outcomes with intravenous~     transplantation of autologous mesenchymal stem cells (MSCs) expanded with autologous serum~     that is obtained at acute phase of stroke than patients receiving standard treatment.~   "
141301|NCT01717768|"~     Low testosterone is a condition that occurs when the body is unable to produce sufficient~     quantities of testosterone. The medical name for low testosterone is hypogonadism.~     Hypogonadism can be caused by many factors. Symptoms include: decrease in libido, lack of~     energy and mood swings. The goal of testosterone replacement therapy is to return~     testosterone levels to the normal range and relieve symptoms.~      The purpose of this study is to evaluate the ability of TSX-002, which is testosterone~     provided in easy to swallow capsules, to maintain serum (blood) testosterone levels within~     the normal range in hypogonadal men. This will be determined by blood sampling at specified~     times during the study. The study is also intended to evaluate the tolerability of TSX-002,~     which will be taken orally twice per day for 15 days. In addition, the study is intended to~     determine a dosing regimen(s) that achieves testosterone levels within the normal range.~     Related Outcome Measures will be reported for Parts 1, 2, and 4.~      A portion of the study (Part 3) to also assess the effect of a high-calorie, high-fat meal on~     the single dose pharmacokinetic exposure of TSX-002. Related outcome measures to be reported~     for Part 3.~   "
141302|NCT01717755|"~     Rationale: Recently our study group reported the results of the Basilar Artery International~     Cooperation Study (BASICS), a prospective registry of patients with an acute symptomatic~     basilar artery occlusion (BAO). Our observations in the BASICS registry underscore that we~     continue to lack a proven treatment modality for patients with an acute BAO and that current~     clinical practice varies widely. Furthermore, the often-held assumption that intra-arterial~     thrombolysis (IAT) is superior to intravenous thrombolysis (IVT) in patients with an acute~     symptomatic BAO is challenged by our data. The BASICS registry was observational and has all~     the limitations of a non-randomised study. Interpretation of results is hampered by the lack~     of a standard treatment protocol for all patients who entered the study.~      Objective: Evaluate the efficacy and safety of IAT in addition to best medical management~     (BMM) in patients with basilar artery occlusion.~      Study design: Randomised, multi-centre, open label, controlled phase III, treatment trial.~      Study population: Patients, aged 18 years and older, with CTA or MRA confirmed basilar~     occlusion.~      Intervention: Patients will be randomised between BMM with additional IAT versus BMM alone.~     IAT has to be initiated within 6 hours from estimated time of BAO. If treated with as part of~     BMM, IVT should be started within 4.5 hours of estimated time of BAO.~      Main study parameters/endpoints: Favorable outcome at day 90 defined as a modified Rankin~     Score (mRS - functional scale) of 0-3.~   "
141303|NCT01717742|"~     Bacterial pneumonia can be complicated by the development of excess fluid and pus (pleural~     empyema) around the lungs in children. The incidence of pleural empyema in children has~     increased significantly in the last 10 years.~      Short term morbidity for this condition is substantial, but unlike in adults, the long term~     outcome of this condition for children in developed countries is favourable. Inserting a~     chest drain and then adding a medicine (tissue plasminogen activator - tPA) to break down~     organized pus has been shown to be an effective therapy for reducing the duration of illness.~     However, this treatment is still suboptimal and prolonged hospitalization is common. Recent~     data from adults suggests that adding an additional medicine (DNase) to decrease the~     viscosity (thickness) of the fluid improves drainage and leads to better patient outcomes;~     however, there are no published studies on children.~      This is a multi-centre randomized controlled trial comparing the time to discharge from~     hospital after chest drain insertion in previously well children who present with pleural~     empyema, treated with intrapleural DNase and tissue plasminogen activator (tPA) by chest~     drain for three doses over 48 hours compared with three doses over 48 hours of tPA alone.~     Other outcomes related to effectiveness, safety and cost will be assessed as well.~   "
141304|NCT01717729|"~     To prospectively evaluate whether use of combined radiofrequency ablation (RFA) and~     percutaneous iodine-125 (125I) seeds implantation results in better survival compared with~     use of RFA alone in patients with hepatocellular carcinoma.~   "
141305|NCT01717716|"~     The purpose is to determine the effect of sugars in solution on food intake and subjective~     appetite in 9- to 14-year-old normal weight boys. The investigators hypothesize that food~     intake after all sugars-containing solutions will be decreased in comparison to the control~     solution, with similar reductions in FI between high-fructose corn syrup -55 (HFCS-55) and~     sucrose. Food intake will be measured 60 minutes after consumption of 50g of HFCS-55, sucrose~     or glucose, or a control treatment. Subjective appetite will be measured at 15, 30, 45, 60~     and 90 minutes.~   "
141306|NCT01717703|"~     The purpose of this experiment was to describe the effect of consuming 350 ml of 1% chocolate~     milk 60 minutes before a pizza meal on subjective appetite and short-term food intake when~     compared to cola, a fruit drink and a water control in normal weight and overweight/obese~     9-14 year old boys and girls. It is hypothesized that 1% chocolate milk will increase meal~     time satiation to a greater extent than other sugars-sweetened commercially available~     beverages. Food intake will be measured 60 minutes after the consumption of 350 ml of water,~     fruit drink, cola or 1% chocolate milk.~   "
141307|NCT01717690|"~     The purpose of this study is to determine whether daily bathing with 2% chlorhexidine~     gluconate-impregnated antiseptic cleanser (CHG) significantly reduces incidence of~     colonization of hospitalized patients with methicillin-resistant Staphylococcus aureus~     (MRSA).~      Investigators postulate that daily bathing with CHG significantly reduces incidence of~     colonization of hospitalized patients with MRSA.~   "
141308|NCT01717677|"~     4arms preference based Study to compare four therapy options in prostate cancer with low or~     early intermediate risk~   "
141309|NCT01717664|"~     The investigators hypothesize that Mycobacterium avium paratuberculosis positive Relapsing~     Remitting MS subjects will have a greater response to Interferon beta-1a therapy plus RHB-104~     than from Interferon beta-1a alone.~   "
141310|NCT01717651|"~     This study is being done to help determine whether patients with severe sepsis (overwhelming~     inflammation in the body as a result of an infection) lose muscle and become weak more~     rapidly than patients with other severe illnesses. Weakness and muscle loss that develops~     after a severe illness is a serious problem. Patients who develop weakness and have a~     decrease in muscle size often have to stay in the hospital longer and have a higher chance of~     dying. At the current time, it is not clear whether certain severe illnesses are more likely~     to cause weakness and muscle loss. This study will be done to measure the changes in muscle~     size and strength as a result of each patient's illness~   "
141311|NCT01717638|"~     It is a Phase 3 extension of study V72P12E1 (NCT00944034). The main aim of the second~     extension study is to explore the bactericidal antibody persistence in 4-year-old children~     after a fourth dose boost of rMenB+OMV NZ or after a two-dose catch-up schedule of rMenB+OMV~     NZ administered to toddlers as part of their respective vaccination courses in study~     V72P12E1.~      In addition, this study will characterize the antibody response to a fifth dose boost in all~     children who received a three-dose primary series of rMenB+OMV NZ at 2, 3, 4 months of age~     (in parent study V72P12, NCT00721396), and only in a subset of children who received a~     three-dose primary series of rMenB+OMV NZ at 2, 4, 6 months of age (in parent study V72P12).~     Antibody response will also be characterized to a third dose boost of rMenB+OMV NZ~     administered at approximately 4 years of age in all children who received a two catch-up~     doses of rMenB+OMV NZ as toddlers in study V72P12E1.~      Finally, the safety and immunogenicity of two catch-up doses of rMenB+OMV NZ administered 2~     months apart to healthy naïve children at 4 years of age will be assessed.~   "
141312|NCT01717625|"~     This study is multicentered, prospective, randomized, opened, parallel, intervention study.~      The aim of this study is to evaluate the efficacy and safety of Montelukast sodium in the~     prevention of bronchopulmonary dysplasia (BPD) in preterm infant, below 32weeks gestational~     age.~      The investigators evaluate the first effectiveness through the morbidity and mortality of~     bronchopulmonary dysplasia. And then, the investigators evaluate the second effectiveness~     through the oxygen index, the usage of mechanical ventilator about taking medicine after 2~     Weeks, Oxygen Utilization After 4 Weeks, Proinflammatory Cytokine through the bronchial~     lavage fluid.~   "
141313|NCT01717612|"~     Though histoacryl injection is now regarded as treatment of choice in the control of gastric~     variceal hemorrhage, it may be associated with a lot of complications such as ulcers, ulcer~     bleeding, bacterial infections, distant site thrombosis and cerebral vascular accident. On~     the other hand, thrombin has been shown to be effective in acute hemostasis of bleeding~     gastric varices, ranging from 70% to 100% has been recorded. The rebleeding rates were~     between 7% and 50%. Moreover, the benefits of thrombin injection include safety, without~     inducing ulcers or ulcer bleeding. No incidence of distant thrombosis has ever been reported.~   "
141314|NCT01717599|"~     Pancreatitis is one of the major complications of ERCP. It has been shown that NSAIDs are~     potent inhibitors of phospholipase A2, activity which is increased in pancreatitis. The only~     one study with IM diclofenac showed reduction of post-ERCP pancreatitis without SOD~     (sphincter of Oddi dysfunction) by subgroup analysis in small study population. Therefore the~     investigators must need large scaled randomized control study including of SOD.~   "
141315|NCT01717586|"~     The primary purpose of this pilot study is to determine the pharmacokinetic (PK) parameters~     and collect preliminary safety data for pravastatin when used as a prophylactic daily~     treatment in pregnant women at high risk of preeclampsia.~   "
141316|NCT01717573|"~     During primary PCI, stent deployment and post-dilatation are associated with no-reflow. The~     mechanisms for no reflow include distal embolization of thrombus, enhanced thrombus formation~     and vascular spasm. No reflow is associated with risk factors such as prolonged duration of~     ischaemia, heavy thrombus burden, persistent ST elevation and long stent length. ACTIVE~     HYPOTHESIS: once normal antegrade flow has been re-established with initial aspiration~     thrombectomy and/or balloon angioplasty at the beginning of primary PCI, compared with usual~     care with direct stenting, a strategy of deferred stenting for 4 -16 hours to permit the~     beneficial effects of normalized coronary blood flow and anti-thrombotic therapies will~     reduce the incidence of no reflow in at-risk STEMI patients. DESIGN: In consecutive STEMI~     patients with risk factors for no reflow and who have given informed consent, when normal~     flow has been established (TIMI 3) by initial aspiration thrombectomy and/or balloon~     angioplasty, participants will be randomized to deferred stenting or usual care with direct~     stenting. All patients will receive dual anti-platelet therapy. Patients who are randomized~     to deferred stenting will receive intravenous glycoprotein IIbIIIa inhibitor and~     anti-coagulation with low molecular weight heparin. Patients who are screened and not~     eligible to be randomized will be prospectively entered into a registry. Study assessments~     for feasibility, safety and efficacy will be prospectively performed. An independent clinical~     event committee will review all serious adverse events. Study endpoints will be subject to~     core laboratory analyses. The study is intended to inform the design of a larger multicentre~     clinical trial.~   "
141317|NCT01717560|"~     The purpose of this study is to examine the feasibility, safety, and effectiveness of~     treating persons who are actively using illicit drugs for hepatitis C using a collaborative,~     multidisciplinary, integrated care model. We hypothesize that by maximizing facilitators and~     minimizing barriers to treatment we can enable drug users to receive effective treatment for~     hepatitis C.~   "
141318|NCT01717547|"~     The aims of this research study are to 1) assess the acceptability and feasibility of~     conducting a yoga-based intervention for Veterans receiving care at a Veterans Affairs~     Medical Center, and 2) obtain preliminary data regarding the effect of the intervention on~     Veteran's mental health.~   "
141319|NCT01717534|"~     The purpose of the planned study is to investigate the effect of heat-treated lactobacilli on~     diarrhea outcome in healthy children 1-4 years old in a randomized, double-blind,~     placebo-controlled study.~   "
141320|NCT01717521|"~     Researchers at the UW are doing this study to find out if a commonly used anesthetic affects~     patients Analgesia Nociception Index (level of pain relief) during abdominal hysterectomy~     under general anesthesia.~      The investigators will administer routine anesthesia care including Ketamine, a commonly used~     anesthetic, during the patients surgery. During the patients surgery, the investigators will~     monitor the patients level of pain relief using the PhysioDoloris monitor, which monitors the~     routinely used EKG monitor. Though not yet FDA approved, the PhysioDoloris is completely~     non-invasive and collects data from the EKG monitor.~   "
141361|NCT01716988|"~     A study of micafungin in ICU versus non-ICU patients showed a significantly lower treatment~     success in ICU patients compared with non-ICU patients. It is known that in critically ill~     patients, alterations in function of various organs and body systems can influence the~     pharmacokinetics and hence the plasma concentration of a drug. The pharmacokinetic parameters~     of micafungin in critically ill patients are most likely different, but this has not been~     specifically studied.~      The pharmacokinetic parameters of micafungin in critically ill patients will be established~     and plasma concentrations of micafungin will be correlated with disease severity.~   "
141321|NCT01717508|"~     The goal of the study is to examine how cognitive behavioral therapy (CBT), a common~     treatment for adolescent depression, affects brain functioning. Depressed adolescents will~     complete an initial assessment consisting of an interview, questionnaires, computer tasks,~     and an EEG recording. EEG (electroencephalography) measures brain activity by recording the~     electrical activity along the scalp caused by the firing of neurons within the brain. They~     will then complete 12 sessions of cognitive behavioral therapy, which will be 50 minutes long~     and held once a week for 12 weeks. Before their third therapy session, participants will~     complete a computer task while EEG data are recorded. After completing the treatment, the~     participants will complete a final assessment, which will include questionnaires, computer~     tasks, and an EEG recording. They will also complete follow-up assessments over the phone 1,~     3, and 6 months after completing the treatment.~      This study will also include healthy control participants. They will complete an initial~     assessment consisting of an interview, questionnaires, computer tasks, and an EEG recording.~     Three weeks later, they will return to complete a behavioral task while EEG data are~     recorded. Twelve weeks after the initial assessment, they will complete a final assessment,~     which will include questionnaires, computer tasks, and an EEG recording.~   "
141322|NCT01717495|"~     This is a large prospective registry of patients submitted to cardiac electronic devices~     implantation designed to investigate the incidence, risk factors and prognostic of~     thromboembolic complications associated with transvenous lead implantation.~   "
141323|NCT01717482|"~     The purpose of this study is to learn whether it is better to receive the drug Metformin with~     standard of care for lung cancer or just standard of care.~   "
141324|NCT01717469|"~     Previous experimental and clinical studies have consistently suggested that right ventricular~     (RV) apical pacing has important adverse effects. Ventricular pacing, however, is required,~     and cannot be reduced in many patients with atrioventricular block. The SAFE-LVPACE study is~     a randomized controlled trial that compare the effects of conventional right ventricular (RV)~     pacing vs. left ventricular (LV) in patients with AV block.~   "
141325|NCT01717456|"~     In previous studies at a university referral center the investigators demonstrated that a~     multicomponent conservative treatment for fecal incontinence was effective. The treatment~     combines patient education with medical management of diarrhea and constipation plus~     behavioral training. The purpose of this study is to determine whether this treatment is~     effective when delivered by home health care nurses to frail elderly patients.~   "
141326|NCT01717443|"~     The purpose of this study is to examine the prevalence, incidence and genotype of anogenital~     HPV infections in women before and after renal transplantation. With this information the~     investigators can determine the value of vaccination in patients waiting for renal~     transplantation in the future.~   "
141327|NCT01717430|"~     Corticosteroid injections into the epidural space or sacroiliac joint are increasingly used~     for the treatment of chronic neck, low back, and leg pain. These injections may have several~     side effects, including suppression of the body's adrenal glands to produce steroids (adrenal~     suppression) and negative effects on metabolism (weight gain, increased blood pressure, and~     high blood sugar levels).~      The purpose of this study is to determine the time course and predictors of adrenal~     suppression and the metabolic effects of corticosteroid injections for chronic pain.~      The investigators hypothesize normalization of adrenal function to occur within three weeks~     of injection in most individuals. An increased frequency of injections is predicted to lead~     to prolonged adrenal suppression. Corticosteroid injections are also hypothesized to lead to~     increases in body weight, blood pressure, and blood sugar levels, particularly in diabetic~     individuals.~   "
141328|NCT01717417|"~     Maxillary canines are the second-most frequently impacted teeth in the dental arch after the~     third molars. The suspicion of a maxilary canine impaction raises with the absence of the~     permanent canine in the arch after the normal period of eruption, and has to be confirmed by~     a clinical evaluation of the patient and a radiographic assessment.~      The approaches to the management of impacted canines are many, but the preferred approach~     typically involves surgical exposure and guided orthodontic eruption.~      The initial mechanical eruption can be achieved in several ways, but an important distinction~     has to be done according to the anchorage method. The aim of this study is comparing~     Temporary Anchorage Devices (TADs), and cantilevers with a TMA sectional, using the~     quantification of canines and molars displacement as the main parameter.~      A TAD is a mini screw temporarily fixed to bone for the purpose of enhancing orthodontic~     anchorage either by supporting the reactive unit (the anchoring tooth) or by obviating the~     need for it at large, and is subsequently removed after use.~      The mini screw employed in this clinical trial will be an alloy type IV titanium screw with~     1.5mm diameter and 8-10 mm long, and under local anesthesia will be placed in an area between~     the first premolar and first molar, on the buccal or labial side according to the canine~     position and teeth position.~      For the evaluation of the canines and molar displacement, two CBCT will be required: the~     first one before the beginning of the traction (T0), the second one after three months (T1).~     Both the CBCT will be imported in the MIMICS image processing software (Materialize Group,~     Leuven, Belgium). Limiting the tissue density ranges and restricting the anatomical area of~     interest, a cropped colored mask will be obtained from each CBCT. Then the co-registration,~     through the identification of 5 at least landmark points, will allow the overlap of the two~     masks. At this point, calculating the 3D surface models, the tooth pre- and post-treatment~     positions will be evident and the measurement of the displacement possible.~   "
141329|NCT01717404|"~     To understand if Mexiletine will restores normal colonic motility in a patient with irritable~     bowel syndrome - constipation (IBS-C) and a genetic mutation in SCN5A.~   "
141330|NCT01717391|"~     [F-18] Fluorothymidine PET imaging will be used to create a radiation therapy treatment plan~     to avoid active bone marrow in the pelvis. This will be done to evaluate if sparing bone~     marrow will help maintain blood counts. This would impact chemotherapy administration.~   "
141331|NCT01717378|"~     The UCSF Clinical and Translational Science Institute (CTSI) Consultation Service provides~     recruitment services and facilitates the enrollment of research participants into UCSF~     clinical studies. The Recruitment Services will be accessible to all researchers at UCSF and~     affiliated institutions and will address the common problems that investigators encounter in~     the recruitment process.~      Recruitment Services considered and integrated Committee on Human Research (CHR) and HIPAA~     regulations for ensuring human subject rights, participant privacy, and data security into~     the recruitment workflow and data collection/extraction methods. Recruitment Services,~     therefore, requests approval to implement these processes systematically for all studies that~     have already obtained CHR approval to begin recruitment activities.~   "
141362|NCT01716975|"~     The purpose of this study is to determine if EVP-6124 (an alpha-7 nAChR agonist) enhances the~     cognitive abilities of subjects with Schizophrenia who are also taking stable antipsychotic~     therapy.~   "
141332|NCT01717365|"~     Data for the study will be collected from therapist across the world. The therapists will~     share data they have already compiled from their caseload. Data will be stripped of all~     personal identifiers and personal health information. The TWU SCOPE research team has no~     contact with clients whose assessment data is being shared for secondary analysis or clinical~     data repository. For educational and training purposes clients can be videotaped by the~     therapist who will obtain consent and/or assent from the client. Not every client will be~     videotaped. The subjects from the data shared by the therapists are from the ages of 0-21,~     both male and female, and of any ethnicity. The total amount of data collected from all~     participating therapists will be 500 pieces.~   "
141333|NCT01717352|"~     The present study will test the effectiveness of two different approaches for preparing~     overweight/obese individuals for weight loss: 1)providing important information about weight~     control, including dispelling common myths; or 2) developing a consistent sleep and eating~     routine to prepare for the challenges of a weight control intervention.~   "
141334|NCT01717339|"~     Obstructive sleep apnea (OSA) is associated with endothelial dysfunction and the development~     of cardiovascular disease. It is unclear how OSA results in endothelial dysfunction, but~     given the association between OSA and obesity, adipose-derived hormones (adipokines) are~     likely to be involved. Leptin, an adipokine upregulated in patients with OSA, has been shown~     to be associated with deleterious effects on vascular function resulting in impaired~     endothelial function. This proposal is directed at investigating the molecular mechanisms of~     endothelial dysfunction in OSA patients. We hypothesize that endothelial dysfunction~     associated with OSA is a result of molecular alterations within endothelial cells. As a part~     of these studies we will look at NO signaling pathways in adipose tissue and microvessels~     from normal and OSA subjects.~   "
141335|NCT01717326|"~     This is a study of the safety and efficacy of grazoprevir (MK-5172) in combination with~     elbasvir (MK-8742) ± ribavirin (RBV). The primary efficacy endpoint will be Sustained~     Virologic Response 12 weeks after the end of all study therapy (SVR12) in each of the~     treatment arms.~   "
141336|NCT01717313|"~     The purpose of this study is to assess the safety and efficacy of omarigliptin (MK-3102),~     dosed once-weekly in participants with T2DM who have inadequate glycemic control on diet and~     exercise. The primary hypothesis is that after 24 weeks, treatment with omarigliptin compared~     with placebo provides greater reduction in hemoglobin A1c (A1C).~   "
141337|NCT01717300|"~     This study will evaluate the effects of 2 different dose levels of anacetrapib on low-density~     lipoprotein-cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C) in~     participants with hypercholesterolemia when added to an existing statin-modifying therapy.~   "
141338|NCT01717287|"~     This multicenter, open-label, noncomparative study evaluates two oral formulations of~     raltegravir (MK-0518, film-coated tablet and chewable tablet) in combination with other~     antiretroviral agents for safety, tolerability, and antiretroviral activity in~     treatment-naive or treatment-experienced Russian children and adolescents infected with human~     immunodeficiency virus-1 (HIV-1).~      As raltegravir is indicated in combination with other antiretroviral therapies (ARTs) for the~     treatment of HIV-1 infection in pediatric patients in the United States (US), this study is~     designed to gain local treatment experience on the use~      of raltegravir in the pediatric HIV-infected population in Russia.~   "
141339|NCT01717274|"~     Many methods have been used to reduce bleeding during sinus surgery (FESS) in order to allow~     for the best surgical view and to reduce risk while in surgery.~      Warm irrigation fluid is believed to accelerate the clotting mechanism in the human body. The~     investigators would like to determine if hot saline irrigation (HSI) compared to room~     temperature saline irrigation (RTSI) can control bleeding during FESS.~      The hypothesis is that HSI is more effective than RTSI in reducing intraoperative bleeding~     during FESS.~   "
141340|NCT01717261|"~     The purpose of this study is to determine if partial breast irradiation administered in a~     single preoperative fraction is tolerable.~   "
141341|NCT01717248|"~     The purpose of this study is to evaluate the safety of GCS-100 as a treatment for chronic~     kidney disease.~   "
141342|NCT01717235|"~     Study subjects were screened and enrolled for the study. Subjects were housed in the clinical~     facility from not less than 12 hours pre-dose till at least 30 hours post-dose in each~     period. After maintaining at least 10 hours of overnight fast Test or Reference product was~     administered orally (as per the randomization schedule) to each subject with about 240 mL of~     water at ambient temperature in each period by trained study personnel.~      The pre-dose (0.00 hours) blood sample was collected before dosing and post-dose samples were~     collected at 2.00, 3.00, 4.00, 5.00, 5.50, 6.00, 6.50, 7.00, 7.50, 8.00, 8.50, 9.00, 9.50,~     10.00, 10.50, 11.00, 12.00, 14.00, 16.00, 20.00, 24.00 and 30.00 hours in each study period~     with a washout period of 7 days between the dosing of two periods. Subjects were continuously~     monitored for well being i.e., blood pressure, radial pulse and oral temperature before~     check-in, prior to drug administration and at regular intervals post dose in each period. The~     concentration of Ropinirole in plasma samples obtained from study subjects was determined~     using validated LC-MS/MS method. Pharmacokinetic and statistical analyses were performed on~     obtained drug concentration data, using appropriate software.~   "
141343|NCT01717222|"~     Laparoscopic Cholecystectomy is the treatment of choice for patients with symptomatic gall~     stones. For pain relief following laparoscopic cholecystectomy both intraperitoneal and~     intravenous administration of lignocaine has been used. But it is not clear from the existing~     literature which form of administration is more effective for pain relief. Hence this study~     has been undertaken with the following hypothesis : Intravenous lignocaine is superior to~     intraperitoneal lignocaine for postoperative pain relief and minimizing the stress response~     in laparoscopic cholecystectomy.~   "
141363|NCT01716962|"~     Fluid responsiveness (FR)refers to the ability of heart to increase its stroke volume in~     response to volume load.Low tidal volume and high PEEP exerts contrast effect on the~     prediction of fluid responsiveness, the aim of this study is to compare the relative~     predicting power of the dynamic preload indicator (PPV, SVV), passive leg raising test, and~     pleth variability index (PVI) on the fluid responsiveness of acute respiratory distress~     syndrome ventilated with various PEEP levels or various tidal volumes.~   "
141344|NCT01717209|"~     Research study evaluating the individual and combined effects of inhaled nitric oxide (iNO)~     and inhaled prostacyclin (iPGI2), on the function of the right heart after surgery for either~     heart transplant or for left ventricular assist device (LVAD) placement. The investigators~     hope to learn if these two medications, when given together after surgery, improve right~     heart function by lowering blood vessel pressures in the lungs. The investigators hope to~     learn if the combined effects of these two medications are better than either medication used~     alone. Participants were selected as a possible participant in this study because right heart~     problems are common during and after surgery for heart transplant and for LVAD placement. In~     addition, iNO is always given during and after these two types of surgeries at Stanford to~     help improve how the right heart functions.~   "
141345|NCT01717196|"~     BACKGROUND: EUS-FNA has a central role in the diagnostic algorithm of solid pancreatic~     masses. Different needle diameters and the use of stylet are not associated with differences~     in terms of diagnostic yield for malignancy. Preliminary studies showed that using suction~     (10ml) is associated with a higher sensitivity for cancer diagnosis. We aim to compare~     EUS-FNA in the same solid pancreatic mass performed with the 22 gauge needle with different~     aspiration volumes (10, 20, 0ml), looking for adequacy, diagnostic accuracy and~     complications.~      METHODS: Prospective clinical study at four referral Centers: ISMETT Palermo;~     Bellaria-Maggiore, Bologna; Civico-A.R.N.A.S, Palermo; Humanitas-IRCCS, Rozzano. EUS was~     performed by five experienced echo-endoscopist. The needle system was in all cases the 22~     gauge EUS-FNA(Expect). We performed three punctures with a 22 G needle with both volume~     aspiration 10 and 20 cc and without syringe for each lesion. The sequence (10cc, 20cc, no~     aspiration) was randomly assigned by sealed envelope system. For each pass tissue samples~     were smeared into slides for ROSE(Rapid-On-Site-Evaluation); after smearing sample into the~     slides, the material was fixed in formalin for cyto-histological evaluation. The~     cyto-pathologist was always blinded as to which aspiration was used for which specimen. After~     EUS-FNA the patients were monitored for at least six hour to detect immediately~     post-procedural complication and were followed up during the 30 days post-procedure in order~     to detect late complications.~   "
141346|NCT01717183|"~     The main purpose of this trial is to demonstrate that the new dressing is more effective than~     the current dressing in the local treatment of chronic foot ulcers in diabetic patients.~   "
141347|NCT01717170|"~     In the STOP-UVEITIS study, we propose to evaluate the safety, tolerability, and bioactivity~     of two doses of Tocilizumab (4mg/kg and 8mg/kg), administered monthly, in patients with~     non-infectious intermediate, posterior, or panuveitis.~   "
141348|NCT01717157|"~     The purpose of this study is to evaluate the pharmacokinetics and relative bioavailability of~     4 new formulations of fentanyl transdermal patch in healthy participants after a single~     application for 72 hours.~   "
141349|NCT01717144|"~     Parkinson's disease (PD) has considerable impact on motor, psychological and social~     activities and significantly affects the quality of life of patients and their families. To~     improve the medical care of PD patients, the investigator have developed an educational~     program specific to PD.~      The principal aim of this study is to evaluate the therapeutic education Program, comparing~     the quality of life of PD patients with or without the educational program after six month~     and one year follow-up.~      The secondary aims are to evaluate the evolution of motor and psychological states in these 2~     groups of patients and to compare the medical costs.~      This is a monocentric, comparative, prospective randomised study. The investigators will~     evaluate 120 PD patients, 60 patients benefiting of the educational program and 60 patients~     with a traditional medical care. Quality of life of PD patients is evaluated using a specific~     scale (PDQ39) and a generalist scale (SF36) at 6 and 12 months. Motor and psychological~     states were assessed with UPDRS and HAD Scales. The educational program consisted of both~     individual and collective educational consultations.~      The investigators supposed that the therapeutic education program will improve the quality of~     life of PD patients. The supposition that this improvement will correlate with the motor and~     psychological states.~   "
141350|NCT01717131|"~     Data from cohorts, prospective studies and one randomized trial (ASCOG Z0011) support the~     hypothesis that omission of additional axillary dissection in case of positive sentinel node~     has a limited impact on overall survival and relapse free survival. However, these data are~     not sufficient enough to recommend, as a standard of care, to avoid axillary dissection in~     case of positive sentinel node. The ASCOG Z0011 trial has been closed before the end of~     inclusions and the predefined non inferiority margin was found to be too large (5% difference~     at 5 years for primary endpoint).~      Prospective randomized trial is then urgently mandatory before omission of axillary node~     dissection becomes a usual practice without a sufficient scientific level of proof. Indeed,~     in several reviews, the rate of omission of axillary node dissection in case of~     micrometastasis increased (Bilimoria) despite any strong proof has been demonstrated.~      The omission of axillary node dissection in case of positive sentinel node may have strong~     practical impacts on patients but also on medical and economical aspects: in avoiding a~     prolonged hospitalisation, secondary morbidities due to axillary dissection requiring~     secondary care and their costs, as well as costs for secondary axillary dissection (14 to 25%~     in case of positive sentinel node) and finally shortening surgery duration.~      The main investigator propose a Non Inferiority Randomized Multicenter Phase III Trial of~     Axillary Node Dissection Versus no Axillary Node Dissection in Case of Positive Sentinel~     Lymph Node in Invasive Breast Cancer~   "
141364|NCT01716949|"~     This trial examines the feasibility, effectiveness and safety of a combination of~     radiotherapy (over a period of five weeks) and chemotherapy (with 5-FU or Capecitabine and~     Oxaliplatin) and 10 fractions of deep regional hyperthermia in patients with primary locally~     advanced or locally recurrent rectal cancer. Previous pelvic irradiation in case of a local~     recurrence is not excluded from the trial. The treatment protocol aims on a preoperatively~     improved tumor regression allowing less aggressive surgery in primary locally advanced rectal~     cancer and a higher rate of curative resections in heavily pretreated locally recurrent~     rectal cancers.~      Primary endpoint of the trial is the feasibility rate of a multimodal regimen consisting of~     radiochemotherapy and hyperthermia. Secondary endpoints are local control, survival rates,~     and toxicity. It is planned to include a total number of 59 patients over a period of 2.5~     years.~   "
141351|NCT01717118|"~     In September 2009 the National Vaccination Council approved the policy for anti-HPV~     vaccination in 9-year-old girls with an extended scheme of 0, 6, and 60 months, under the~     following justification:~        -  Antibody induction due to the vaccine is greater than that produced by natural exposure~          to the virus~        -  Immune response in girls 9 to 11 years of age is similar to the response obtained after~          three doses in women 16 to 26 years of age~        -  The third dose will be administered at the time when maximum protection is required,~          near the onset of sexual activity Thus the National Institute of Public Health was~          commissioned to monitor anti-HPV antibody levels in women who received the anti-HPV~          vaccine to determine non-inferiority of the extended scheme in 9-year-old girls compared~          with the traditional scheme of 3 doses in women 18 to 24 years of age. To this end, a~          sentinel cohort will be formed to evaluate immunogenicity levels in 3 age groups, and~          stratified by vaccine type. The hypothesis is that in 9-year-old girls who are~          administered the amplified HPV vaccination scheme (0-6-60) show immunogenicity levels~          that are not lower than those of adult women who have been administered the traditional~          scheme (0-1/2-6).~      The main objectives are to monitor the levels of immunity induced by vaccination against HPV~     with two vaccination schemes with the quadrivalent vaccine: Traditional Extended (0-6-60~     months) and traditional (0-2-6); Monitoring levels of immunity induced by vaccination against~     HPV with three vaccine schemes with bivalent vaccine: Extended (0-6-60 months), traditional~     (0-1-6) and two doses (0- 6); as well as evaluating the interchangeability of the bivalent~     and quadrivalent vaccines in the third dose of extended scheme. The study design is to create~     a sentinel cohort of women vaccinated against HPV in the following comparison groups:~        -  Women of nine years with extended vaccination scheme with three doses of quadrivalent~          vaccine (0-6-60)~        -  Women of nine years with extended vaccination scheme with two doses of the quadrivalent~          vaccine and the third dose with bivalent (0-6-60)~        -  Women of nine years with traditional vaccination scheme with the quadrivalent HPV~          vaccine (0-2-6)~        -  Women between 18 and 24 years with traditional vaccination scheme with the quadrivalent~          HPV vaccine (0-2-6)~        -  Women of nine years with extended vaccination scheme with three doses of bivalent~          vaccine (0-6-60)~        -  Women of nine years with extended vaccination scheme with two doses of bivalent vaccine~          and the third tetravalent dose~        -  Women of nine years with two vaccine doses scheme with the bivalent HPV vaccine (0-6)~        -  Women of nine years with traditional vaccination scheme with bivalent HPV vaccine~          (0-1-6)~        -  Women between 18 and 24 years with traditional vaccination scheme with bivalent HPV~          vaccine (0-1-6)~        -  To monitoring HPV infections, at month 61 of follow-up, a group of 400 women aged 14-15~          years, who have not been vaccinated against HPV, will be invited , in order to make the~          monitoring of occurrence of HPV infections in urine per month 61, 72, 96 and 120 post~          dose 0 in vaccinated groups~   "
141352|NCT01717105|"~     The present study has been designed in order to characterize the incidence of patients with~     advanced non-small cell lung cancer (NSCLC) carrying epidermal growth factor receptor (EGFR)~     positive mutations and their clinical management in Galicia.~   "
141353|NCT01717092|"~     Chronic thromboembolic pulmonary hypertension (CTPH) is associated with considerable~     morbidity and mortality. Its incidence after pulmonary embolism and associated risk factors~     are not well documented in Chinese population. We conducted a prospective, long-term,~     follow-up study to assess the incidence of symptomatic CTPH in consecutive patients with an~     acute episode of pulmonary embolism but without prior venous thromboembolism. Patients with~     unexplained persistent dyspnea during follow-up underwent transthoracic echocardiography and,~     if supportive findings were present, ventilation-perfusion lung scanning and pulmonary~     angiography. CTPH was considered to be present if systolic and mean pulmonary-artery~     pressures exceeded 40 mm Hg and 25 mm Hg, respectively; pulmonary-capillary wedge pressure~     was normal; and there was angiographic evidence of disease.~   "
141354|NCT01717079|"~     Anorexia nervosa (AN) is a frequent, potentially life-threatening eating disorder~     characterized by a resistance to maintaining body weight at or above a minimally normal~     weight for age and height, an intense fear of weight gain or being fat even though~     underweight, a loss of menstrual periods in girls and women post-puberty and a disturbance in~     the experience of body weight or shape. Body weight and shape dissatisfaction is linked to~     the development, maintenance and relapse of AN. Neuroimaging studies have shown that the~     inferior parietal cortex is involved in body image perception and less activated in patients~     with AN compared with healthy subjects. Repetitive transcranial magnetic stimulation (rTMS)~     is used to modulate cortical excitability, and particularly to increase excitability with~     high-frequency rTMS. The aim of this study was to investigate the effect of excitatory~     high-frequency rTMS over the hypoactive inferior parietal cortex of 54 patients with AN.~      This randomized, double-blind, placebo-controlled study will compare effective rTMS (2000~     ten-Hz stimulations per session, applied at 90% of the resting motor threshold, with 10~     sessions in two weeks) versus placebo rTMS.~      Assessments will be performed before rTMS and after the last rTMS session (immediately after,~     at 15 days and three months). The principal criteria for judgement is a body image~     satisfaction scale (Boby Shape Questionnaire, BSQ-34). The secondary criteria for judgement~     are eating behaviour scales (Eating Attitude Test, EAT-40; Bulimia test, BULIT and Eating~     Disorders Inventory, EDI-2), the Hamilton depression rating scale and Hamilton anxiety rating~     scale, a quality of life scale (Short-Form Health Survey, SF-36), a body composition analysis~     using a Dual-energy X-ray absorptiometry and the alpha-MSH autoantibodies levels (biomarker~     for eating disorders recently described).~      Inferior parietal cortex rTMS could not only improve body image perception, but also help in~     the treatment of eating disorders, allowing weight gain with a decreased anxiety and~     improving patients' quality of life. Also positive results could have direct therapeutic~     implications with the possibility to complete regular rTMS sessions, or to implant extradural~     electrodes for chronic parietal cortex stimulation.~   "
141355|NCT01717066|"~     Using the subject with hepatocellular carcinoma in the conventional therapy to evaluate the~     efficacy and safety of ginsenoside Rg3 (20mg BID) and placebo in prevention and treatment of~     postoperative recurrence of liver cancer,respectively~   "
141356|NCT01717053|"~     The addition of abiraterone acetate to standard treatment of radiotherapy and short-term~     androgen deprivation will increase the frequency of undetectable PSA.~   "
141357|NCT01717040|"~     The primary objective is to test the hypothesis that adjunctive pioglitazone is more~     effective than placebo for the relief of acute depressive symptoms resulting from bipolar~     disorder. The secondary objectives are to determine potential moderators and mediators of~     antidepressant efficacy.~   "
141358|NCT01717027|"~     To estimate the pharmacokinetics and relative bioavailability of oxycodone after~     administration of 40 mg doses of PF-00345439 formulations taken whole under fed conditions~     and after chewing under fasted conditions in healthy volunteers~   "
141359|NCT01717014|"~     The purpose of this research study is to evaluate the safety and feasibility of the Radial~     Reload Stapler during open LAR for rectal cancer. The surgeon will complete questionnaires~     relating to the function of the device.~   "
141360|NCT01717001|"~     A better understanding of knee joint kinematics is important to explain the premature~     polyethylene wear failures within total knee arthroplasties (TKAs) and to help design a~     prosthesis that most closely approximates the normal knee. Previously, most experimental~     studies of knee kinematics have involved cadaveric, in vitro analyses, or have not tested the~     knee in a weight-bearing mode. Others have used exoskeletal linkages and skin markers that~     permit error due to undesired motions between markers and the underlying bone. More recently,~     fluoroscopy has been used to assess in vivo kinematics for subjects having a TKA.~      ConforMIS has attempted to follow a clearly different path than the major orthopaedic~     companies. They have chosen to offer patients a personalized knee implant based off of each~     patient's femoral and tibial bone geometry. The hypothesis is that these subjects will~     experience a more normal-like kinematic pattern, eliminating paradoxical anterior sliding~     during weight-bearing knee flexion. Therefore, the objective for this study is to analyze the~     in vivo kinematics for 25 patients implanted with a personalized ConforMIS TKA and 25~     patients implanted with a traditional TKA design to determine if there are any kinematic~     differences between these TKA designs.~   "
141365|NCT01716936|"~     The purpose of this study is to determine the safety profile and probable benefit of the~     Ellipse Technologies Inc. MAGEC System in subjects with early onset spinal deformity~     associated with thoracic insufficiency syndrome.~   "
141367|NCT01716910|"~     This is a randomized, double-blind, placebo controlled, cross-over, single centre, 14 week~     clinical trial on healthy volunteers. Following a two week run-in-period, subjects were~     randomized, and treatment with synbiotic or placebo for 21 days was given, followed by a~     3-week wash-out period before the second treatment period, followed by a another wash-out~     period. Volunteers completed questionnaires for each period on overall health and well being,~     stool frequency and consistency and gastrointestinal symptoms. The subjects were asked to~     collect fecal samples for investigation of microbiological and microbial metabolites before~     and after three treatment periods. The primary objective of the study is tan increase in~     fecal butyrate concentration. Secondary objectives are changes in microbiota composition and~     short-chain fatty acids.~   "
141368|NCT01716897|"~     This study will be a single-center, open-label, randomized, 3-treatment crossover study of~     single oral doses of an API-capsule formulation of E2609 under fasted conditions and a tablet~     formulation administered under fed and fasted conditions in healthy subjects.~   "
141369|NCT01716884|"~     1. Registration~        2. Performing in three stages~        3. Major aim: Much more and standard reperfusion therapy in STEMI patients~   "
141370|NCT01716871|"~     Introduction: The military population is at high-risk for injury with by painful sprains,~     especially of the ankle. The referenced treatment method for pain is the cryotherapy,~     consisting in applying cold-packs to the injured ankle several times a day. However, another~     pain treatment has been developed and is commonly used by high-level sports teams and~     rheumatologists but its efficacy has never been assessed within a military population, i.e.~     the hyperbaric CO2 cryotherapy, also called the neurocryostimulation.~      Research design: This study was carried out on a French multicenter basis, the study~     consisting in a randomized controlled superiority trial and open-label prospective analysis~     in the treatment of 40-year-old military patients or younger suffering from acute ankle~     sprains. Two groups were made: patients were treated either by neurocryostimulation or by the~     referenced cryotherapy (cold-packs). The care protocol for both groups consisted in six~     supervised 30 minute-sessions within a period of three consecutive days.~      Hypothesis: Neurocryostimulation is more effective in the treatment of pain severity~     resulting from an ankle sprain than the referenced treatment by cold-packs. Moreover, we~     theorized that the total consumption of paracetamol and the number of days of temporary~     inaptitude and of work exemption were lower in patients treated by neurocryostimulation.~      Outcomes:~      For each session, pain severity is assessed on a 100-mm Visual Analog Scale at the beginning~     and at the end of session 20 minutes later after a four-step walk.~   "
141371|NCT01716858|"~     Accumulating evidence suggests a role of oxidative stress in the pathophysiology of~     schizophrenia. The potent antioxidant sulforaphane (SFN) is an organosulfur compound derived~     from a glucosinolate precursor found in cruciferous vegetables such as broccoli, Brussels~     sprouts and cabbage. The protection afforded by SFN is thought to be mediated via activation~     of the NF-E2-related factor-2 (Nrf2) pathway and subsequent up-regulation of phase II~     detoxification enzymes and antioxidant proteins, through an enhancer sequence referred to as~     the electrophilic responsive element or antioxidant responsive element. Recently, we reported~     that SFN could attenuate behavioral abnormalities in mice after the NMDA receptor antagonist~     phencyclidine. Considering the potent antioxidant effects of SFN, we have a hypothesis that~     SFN would be a potential therapeutic drug for schizophrenia. The purpose of this study is to~     determine whether SFN-rich broccoli sprout extract have beneficial effects in patients with~     schizophrenia.~   "
141372|NCT01716845|"~     This study will prospectively enroll approximately 660 children, at least 18 months and less~     than 5 years of age, who have been referred to a pediatric developmental evaluation centers.~     Enrolled children will have blood drawn for RNA gene expression analysis and undergo a~     clinical evaluation to determine the presence or absence of a diagnosis of ASD.~      The sequential co-primary objectives of this study are:~        -  To develop an algorithm to classify blood RNA gene expression patterns to maximize~          agreement between the classification and a clinical assessment of presence or absence of~          Autism Spectrum Disorders (ASD).~        -  To prospectively assess the clinical sensitivity and specificity of the blood RNA gene~          expression classification algorithm (the SDX-002 test) in children referred to a~          developmental evaluation clinic for a possible developmental disorder.~   "
141373|NCT01716832|"~     The effectiveness of a mindfulness walking program is tested in subjects with a high level of~     subjectively perceived stress.~   "
141374|NCT01716819|"~     R2C2 study has shown that abdominal obesity is associated with a cardiac and vascular~     remodelling in healthy volunteers. This remodelling is correlated with renin-angiotensin~     aldosterone system (RAAS) activation and/or systemic fibrosis. R2C2 II study is designed to~     confirm the hypothesis that RAAS is associated with an early remodelling and implicated in~     the transition to cardiac failure in abdominal obesity.~   "
141375|NCT01716806|"~     This is an open-label, multicenter, phase 2 clinical trial designed to evaluate the efficacy~     and safety of brentuximab vedotin as a single-agent (Part A) and in combination with~     dacarbazine (Part B), bendamustine (Part C), or nivolumab (Part D) in front-line therapy of~     HL in adults age 60 and above.~   "
141376|NCT01716793|"~     In a protocol of treatment of AML used in 1994 for adults with AML up to the age of 50 years,~     the Spanish CETLAM group showed a complete remission rate 75 % using the combination of~     daunorubicin (60 mg/m2, 3 days) plus conventional dose cytarabine (100mg/m2/day in continuous~     infusion during 7 days) and etoposide (100mg/m2 IV/day 3 days). If idarubicin (10 mg/m2, 3~     days) was administered instead of daunorubicin, the complete remission (CR) rate in adults up~     to 60 years was 75%. To improve the proportion of CRs and to decrease relapse rate appearing~     in 50% of patients, the phase II AML-99 trial includes intermediate dose-cytarabine during~     induction and risk-adapted post remission treatment based on the improvement in prognostic~     characterization of AML and the implementation of novel transplantation techniques.~   "
141401|NCT01716468|"~     The purpose of this study is to determine the safety and tolerability of a modified low~     carbohydrate diet, determine if quality of life is improved and to determine if the diet has~     any effect on tumor growth (size or spread) and or to determine if there is any effect on~     progression free survival (PFS) and overall survival (OS) of subjects enrolled in the study.~   "
141377|NCT01716780|"~     This study is looking at treating cancer pain in head and neck cancer. Patients are asked in~     outpatients to score their worst pain on a scale of 0 to 10 in the last 24 hours. Those with~     a pain score of 4 and above are randomised into the study.~      Patients are allocated to continue with their current care (control group) or to be reviewed~     by the pain/palliative care team (intervention group). At baseline questionnaires are~     completed on level of pain, type of pain, quality of life and anxiety/depression. Information~     is also collected on the analgesia they've used in the past month and basic health economics~     (GP/hospital visits related to pain management and treatment).~      Follow up in the trial is for 3 months and consists of questionnaires as above and further~     collection of information on analgesic usage and health economics.~   "
141378|NCT01716767|"~     Topical menthol gels are classified 'topical analgesics' and are used to relieve pain of the~     musculoskeletal system. However, double-blind randomized controlled trials are lacking. Here~     the investigators examine - in a double-blind randomized controlled cross-over trial - the~     acute effect of topical menthol (Biofreeze) and placebo (gel with a menthol scent) on pain~     symptoms in slaughterhouse workers with symptoms of Carpal Tunnel Syndrome.~   "
141379|NCT01716754|"~     This study assessed the effect on asthma control of different dose levels and regimens of~     QGE031 in asthma patients that are inadequately controlled with inhaled steroid and beta-2~     agonist medication. Safety was assessed also. Comparison was to placebo and omalizumab.~     Information from this study was planned to support the design of future studies.~   "
141380|NCT01716741|"~     Partners HealthCare maintains a Patient Data Registry (PDR) with information from all patient~     encounters at Partners HealthCare facilities. We intend to utilize the PDR to identify groups~     of patient who are of high clinical suspicion for undiagnosed Gaucher disease. A group of~     potential participants will be identified through the PDR. Detailed records will be requested~     to further narrow to ideal participants based upon previously existing diagnoses and~     symptoms. Participants will be invited to partake in the study via a letter from their~     Partners care provider with supporting study details. Study participants will be evaluated in~     a one-time visit. A complete family and medical history will be collected. A physical exam~     will be performed, and up to 20cc of blood will be drawn. All participants will be notified~     of their disease status via letter and phone call from the study staff. If the study~     participant is diagnosed with GD through this evaluation, proper follow-up recommendations~     and referrals will be provided. Our intent is to determine if existing patient data can~     successfully be utilized to aid in the identification of patients with rare genetic disease.~   "
141381|NCT01716728|"~     Partners HealthCare maintains a Patient Data Registry (PDR) with information from all patient~     encounters at Partners HealthCare facilities. We intend to utilize the PDR to identify groups~     of patient who are of high clinical suspicion for undiagnosed lysosomal acid lipase~     deficiency. A group of potential participants will be identified through the PDR. Detailed~     records will be requested to further narrow to ideal participants based upon previously~     existing diagnoses and symptoms. Participants will be invited to partake in the study via a~     letter from their Partners care provider with supporting study details. Study participants~     will be evaluated in a one-time visit. A complete family and medical history will be~     collected. A physical exam will be performed, and up to 20cc of blood will be drawn. All~     participants will be notified of their disease status via letter and phone call from the~     study staff. If the study participant is diagnosed with LALD through this evaluation, proper~     follow-up recommendations and referrals will be provided. Our intent is to determine if~     existing patient data can successfully be utilized to aid in the identification of patients~     with rare genetic disease.~   "
141382|NCT01716715|"~     This randomized phase II trial studies how well giving cabozantinib-s-malate or paclitaxel~     works in treating patients with persistent or recurrent epithelial ovarian, fallopian tube,~     or primary peritoneal cavity cancer. Cabozantinib-s-malate may stop the growth of tumor cells~     by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as~     paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the~     cells or by stopping them from dividing. It is not yet known whether cabozantinib-s-malate or~     paclitaxel is more effective at treating patients with persistent or recurrent epithelial~     ovarian, fallopian tube, or primary peritoneal cavity cancer.~   "
141383|NCT01716702|"~     Background: Prostate cancer (PCa) is the most common cancer for men. When treated early~     enough it is typically curable. However, common treatments, such as radical prostatectomy and~     radiation therapy, often result in significant negative outcomes with regard to sexual,~     psychological and social function. Both men and partners have identified the need for more~     information and support to address sexual health concerns after treatment. However, very few~     sexual rehabilitation interventions have been developed and rigorously assessed.~      Purpose: The investigators propose to develop and pilot test a new program to meet the sexual~     health needs of men with PCa and their partners using an online, professionally facilitated~     education/support program. The goals of the program are to improve sexual function, intimacy~     and mood for men and their partners after treatment for localized PCa. The program will be~     offered through Cancer Chat Canada, an existing and well-tested Canadian platform for~     professionally facilitated support group programs.~      What Participants Can Expect: A total of 24 men and their female partners (48 individuals)~     will be recruited and assigned to one of two groups. The first group will participate in the~     program immediately; the second group will be offered the program after a 5-month delay. The~     decision about which group will start immediately and which later will be made randomly (by~     chance). Both groups of men and partners will be asked to complete questionnaires three times~     and, at the end of the program, to provide the researchers feedback about how satisfied they~     were with the program, the changes they made, things they learned as a result of the program,~     and suggestions for improving the program. Participants must have access to a computer, an~     Internet connection and be willing to attend online, chat room meetings each week for 1.5~     hours for 6 weeks.~      Implications: Sexual rehabilitation is a high need for men affected by PCa, but is difficult~     to access. The investigators hope to improve access to sexual health care through this study.~   "
141384|NCT01716689|"~     This is a single arm phase II clinical study to evaluate the efficacy and safety of~     metronomic oral cyclophosphamide in elderly and/or pre-treated patients with advanced~     sarcomas.~   "
141402|NCT01716455|"~     Shire is developing SSP-004184 (FBS0701), a novel iron chelator , for the treatment of~     chronic iron overload in patients with transfusion-dependent hereditary and acquired anemias.~     The primary purpose of the study is to assess the pharmacokinetics of SSP-004184 (FBS0701)~     following a single 75mg/kg dose of SSP-004184 (FBS0701) in healthy adults and elderly~     subjects and in adult subjects with mild, moderate, severe, and end stage renal disease~     (ESRD) degrees of impaired renal function. The results of this study will characterize the~     pharmacokinetics, safety, and tolerability of SSP-004184 (FBS0701) in adult subjects with~     various degrees of renal impairment, and these data will be compared to healthy adult and~     elderly subjects.~   "
141385|NCT01716676|"~     In recent years medicine has been enhanced by the incorporation of technological innovations~     from areas as diverse as cell biology, biochemistry, genetics, biophysics and bioengineering.~     One of the few exceptions in this rapid process of implementing technological advances occurs~     in clinical medicine, where its penetration is much less effective than in other scientific~     and professional fields, or even in everyday life. Attempts to tackle this problem have given~     rise to various initiatives in the US and Europe, including Spain.~      There is a surprising paucity of telemedicine systems in clinical practice, especially with~     respect to sleep-related breathing disorders, and most particularly obstructive sleep apnea~     (OSA), where protocols are urgently needed to alleviate this healthcare problem represented~     by its under-diagnosis and comorbidity, as well as the long waiting lists for treatment. In~     others words, the growing awareness of sleep disorders, especially OSA, has not been~     accompanied by strategic changes in the cost-effective diagnosis and/or treatment of these~     diseases.~      CPAP therapy compliance is not always appropriate. Helping patients during the first two~     months usually determines compliance. Therefore, the development of strategies to support the~     patient during the first weeks is essential. However, this collides with reality, where it~     is difficult to properly care all patients because of congested sleep units. It is therefore~     necessary to implement new and imaginative control schemes especially at the beginning of the~     treatment. Patients' follow-up performed by telemedicine technology is an option that aims to~     substitute the face-to-face visits or at least reduce them considerably. In a future context,~     the idea is that the professional in charge of CPAP patients monitoring has on his/her agenda~     face-to-face visits and televisits (at distance) and information which patient will provide~     through online questionnaires with a certain frequency.~      In this sense, this project aims to analyze whether CPAP treatment compliance of OSA patients~     monitored by telemedicine techniques (website and televisits) is similar to that achieved by~     standard monitoring but more cost-effective. The study design is a multicenter randomized~     trial with parallel groups and blind final evaluation after CPAP treatment following two~     different strategies: one through conventional monitoring in the hospital (face-to-face~     visiting) and another by telemedicine monitoring (non-contact visiting and website).~   "
141386|NCT01716663|"~     This is a prospective, multicenter, non-randomized observational study of subjects 18 years~     and older undergoing RF ablation with drug refractory recurrent symptomatic paroxysmal Atrial~     Fibrillation (AF).~   "
141387|NCT01716650|"~     To assess the pain scores before and after saphenous nerve block placement in patients with~     degenerative joint disease of the ankle~   "
141388|NCT01716637|"~     While the cause of AD is still unknown, evidence suggests it develops because of a complex~     series of events in the brain that occur over time. Two pathways possibly involved in~     development of AD are inflammation and oxidative stress. Scientists have linked chronic~     inflammatory events in the brain with the onset and progression of Alzheimer's Disease.~     Oxidative stress has also been implicated in the pathogenesis of a number of neurological~     disorders including Alzheimer's Disease.~      Etanercept (Enbrel®) is an approved drug for the treatment of several forms of arthritis when~     administered by injection. Some research suggests that etanercept, when administered by~     injection into the tissues close to the spinal column (perispinally), may modulate certain~     aspects of the immune system and provide some beneficial effect for people with Alzheimer's~     disease. Studies suggest that supplementation with specific nutrients may also have a~     positive effect in support of cognitive function.~      This study will be conducted at one research office with volunteers who have been diagnosed~     with mild to moderate Alzheimer's disease. Each qualifying participant will be randomly~     assigned to receive an etanercept injection plus nutritional supplements for 6 weeks followed~     by a crossover and a washout period of 4 weeks to then receiving nutritional supplements~     alone or vice versa for another 6 weeks.~      Participants will undergo blood and urine safety assessments at the beginning and end of each~     6 week treatment period. During 4 of the 6 weekly visits in the treatment period with the~     injections, you will complete the cognitive tests twice; once before and once 2 hours after~     the injection. During 4 of the 6 weekly visits in the treatment period without the~     injections, you will also complete the cognitive tests twice; once before and once 2 hours~     after being asked to lie down onto a table for 5 minutes. You will be allowed to continue~     your standard of care for Alzheimer's disease throughout your participation in the study.~   "
141389|NCT01716624|"~     The purpose of this study is to investigate the use of Botulinum Toxin A as primary therapy~     for children with neurogenic bladder due to spina bifida and compare results with standard~     oral oxybutynin therapy. This study hopes to demonstrate that Botulinum Toxin A can maintain~     or improve bladder storage function without side effects associated with oxybutynin use.~   "
141390|NCT01716611|"~     The purpose of the study is to investigate the efficacy and safety for the management of~     hyponatremia and ascites in patients with liver cirrhosis.~   "
141391|NCT01716598|"~     Targeted Lung Denervation (TLD) Therapy will be a safe method to ablate the airway nerve~     trunks that travel parallel to and outside of the main bronchi and into the lungs to achieve~     targeted lung denervation and potentially improve breathing and quality of life for patients~     suffering from COPD.~      Use of the IPS System will be technically feasible in accessing the target treatment location~     and delivering RF energy to the target treatment location.~   "
141392|NCT01716585|"~     The purpose of this study is to evaluate the safety and efficacy of ABT-450, ritonavir and~     ABT-267 (ABT-450/r/ABT-267; ABT-267 also known as ombitasvir) and ABT-333 (also known as~     dasabuvir) co-administered with ribavirin (RBV) in hepatitis C virus genotype 1 infected~     treatment-naïve adults.~   "
141393|NCT01716572|"~     The researchers will investigate whether erythromycin infusion is better than gastric lavage~     prior to emergency endoscopy to improve the quality of examination in patients with upper~     gastrointestinal bleeding.~   "
141394|NCT01716559|"~     This observational, prospective, multicenter study will evaluate the treatment response rate~     and the safety of NeoRecormon (epoetin beta) in anemic patients with non-myeloid malignancy.~     In addition to NeoRecormon, patients receive chemotherapy for their malignancy. Data will be~     collected for 16 weeks.~   "
141395|NCT01716546|"~     Investigators propose to study the effect of panitumumab when combined with an active~     regimen, such as DCF (Docetaxel/Cisplatin/Fluourouracil), in previously untreated patients~     with advanced cancer of the stomach.~   "
141396|NCT01716533|"~     This study aims to 1) evaluate the C. difficile-specific immune response in CDI patients and~     2) explore the difference in immune response between the patients with CDI recurrence and~     those with a sustained clinical response.~   "
141397|NCT01716520|"~     The purpose of this study is to evaluate the lung function response to UMEC/VI, UMEC, and VI~     in individual patients using a cross-over design. This is a multicenter, randomized,~     double-blind, 3-way crossover study. Eligible subjects will be randomized to a sequence of~     UMEC 62.5mcg, VI 25mcg, and UMEC/VI 62.5/25mcg. All subjects will receive each treatment~     once-daily for 14 days, and each treatment will be separated by a 10-14 day washout period.~     There will be a 5-7 day run-in period prior to randomization.~   "
141398|NCT01716507|"~     This study is a comparison (23 gauge vs 20 gauge instrumentation) of surgical instrumentation~     for retinal detachment repair.~   "
141399|NCT01716494|"~     The overall goal of this proposal is to better understand the basis of airway remodeling in~     severe asthma and how remodeling changes over time. The investigators propose to study a~     well-characterized cohort of adult and pediatric subjects with severe asthma using a~     multidisciplinary state-of-the-art approach.~   "
142506|NCT01702012|"~     A 12 month multi-center randomization controlled study. Participants will be randomized to~     either a lifestyle education program or a meal replacement regimen with Almased, after an~     initial examination of eligibility criteria.~      Primary outcome-HbA1c~   "
141403|NCT01716442|"~     Anti-CD20 agent has been proposed as a rescue therapy for refractory nephrotic syndrome(NS)~     on the basis of favorable clinical observations. Yet the long-term effect on maintaining~     remission or the likelihood of becoming rituximab-dependent is unclear and the information on~     the safety profile of rituximab is limited. This trial was designed to investigate the safety~     and efficacy of Rituximab in children with refractory NS.~   "
141404|NCT01716429|"~     This study will be a 6-month intervention that is examining how different dietary approached~     may be useful for women with Polycystic Ovarian Syndrome (PCOS) who are attempting pregnancy,~     particularly by measuring changes in weight. Participants will be randomly assigned to~     following one of two dietary approaches for weight loss: 1) a low-calorie approach to weight~     loss (reducing caloric intake by approximately 500 calories per day) or 2) a low-fat,~     low-glycemic index vegan diet. A vegan diet is one that does not contain any animal products~     (no meat, fish, poultry, eggs, or dairy) but emphasizes plant-based foods, such as fruits,~     vegetables, whole grains, and legumes/beans. In addition, this diet will be low-glycemic~     index, which means the consumer will be asked to favor foods that don't cause a quick rise in~     blood sugar (for example, favoring oatmeal over cornflakes for breakfast). Participants will~     receive counseling and supporting materials on the dietary approach the participants are~     assigned to follow. Both diets are safe and have shown to be effective ways to assist with~     achieving a healthy weight. The investigators hypothesize that both groups will see~     improvements in weight and fertility with possible greater improvements seen among~     participants in the vegan group.~   "
141405|NCT01716416|"~     This phase I trial studies the side effects and best dose of pazopanib hydrochloride~     (pazopanib) when given together with cetuximab in treating patients with incurable recurrent~     or metastatic head and neck cancer. Pazopanib may stop the growth of cancer by blocking blood~     flow to the tumor. Pazopanib may also block some of the enzymes needed for cell growth.~     Cetuximab is a monoclonal antibody that blocks the ability of some tumor cells to grow and~     spread. Giving pazopanib with cetuximab may provide a more effective treatment for patients~     with advanced head and neck cancer.~   "
141406|NCT01716403|"~     The risk of severe anemia is increased in patients treated by tri-therapy compared to~     patients treated by bitherapy. The underlying mechanisms involved in this toxicity remain~     unexplored but could also depend on the global exposure of telaprevir. The trough~     concentration or AUC of telaprevir could therefore be a predictive factor of the onset of~     anemia in patients treated by ribavirin/PEG-INF/telaprevir. The early measurement of~     telaprevir and ribavirin concentrations could help to manage HCV tri-therapy to improve~     tolerance and SVR.~   "
141407|NCT01716390|"~     To determine the effect of investigational products on serum LDL cholesterol.~   "
141408|NCT01716377|"~     Purpose: The purpose of this study is to demonstrate the potential efficacy of venlafaxine~     administration in reducing acute and chronic musculoskeletal pain in individuals presenting~     to the ED for evaluation after motor vehicle collision.~      Participants: Participants will consist of 60 patients between the ages of 18-50 who present~     to the ED within 12 hours post-motor vehicle collision. Patients who report a neck pain score~     > 6 will be screened for further eligibility.~      Procedures (methods): Using a placebo-controlled, randomized, double-blind trial design, 60~     high risk patients will be randomized to venlafaxine vs. placebo in the ED. The ability of~     venlafaxine to decrease acute and persistent musculoskeletal neck pain will be assessed~     during serial short-term telephone follow-ups as well as more in-depth follow-ups at 6 weeks,~     4 months, and 6 months post-MVC.~   "
141409|NCT01716364|"~     Patients with some forms of acute myeloid leukemia (AML) and multiple myeloma (MM) are not~     cured with conventional therapy and new approaches are needed. For the last 15 years we have~     investigated the potential of using a patient's own T cells (a type of white blood cell~     [WBC]) to eradicate the tumor. We have demonstrated the feasibility of this approach in cell~     culture and animal models of AML and MM. Over the last 5 years we have been preparing to~     treat patients as part of a Phase I (first in human) clinical trial.~      The trial treatment involves collecting the patient's own WBCs from the blood by a standard~     well established and safe process called apheresis. The cells are then cultured in a~     specialized laboratory (under Good Manufacturing Practice conditions, similar to standards~     under which pharmaceuticals are produced) over 12 days to convert the cells to specialized~     tumor-attacking T cells. Early in that culture process the cells are exposed to a virus (that~     is modified so that it cannot infect or replicate outside the special culture conditions)~     that contains a special gene. Via the virus, this gene inserts into the patient's T cells in~     culture and gets incorporated into the T cell's genetic machinery. As the T cells replicate,~     the new gene produces a protein receptor that becomes part of the patient's T cells. This~     protein receptor on the T cells has the capacity to specifically recognize and bind to a~     protein on the leukemia or myeloma cells called the Lewis Y antigen.~      After the modified T cells are infused into the patient, they home into the bone marrow (this~     tracking is monitored by special radiological techniques) where the new protein receptor on~     the T cell surface can recognize and bind to the cancer cells (which express Lewis Y). Once~     bound onto the cancer cells, the T cells get activated and subsequently replicate and kill~     the cancer cells. The novelty of this approach is that the T-cells will only kill cells that~     have the Lewis Y on their surface - the cancer cells. Moreover, because there are few normal~     cells in a person's body that carry Lewis Y, this treatment is likely to only have minor side~     effects.~      This gene therapy trial is unique and although the primary purpose is to test the safety of~     this approach, patients will be monitored closely for anti-tumor responses. As the trial~     progresses, the dose of T cells infused will increase, in the hope that this will result in a~     better and stronger immune response to the leukemia or myeloma.~   "
141410|NCT01716351|"~     Psychosocial risks are significant in the management of patients with cardiovascular disease~     and implantable cardioverter defibrillators (ICD) devices. This is a randomized, controlled,~     clinical study. The hypothesis is that adapted yoga (vs. usual care) will significantly~     reduce psychosocial risks (e.g. anxiety and depression symptoms) and improve the quality of~     life in ICD patients. The specialized, real-time data, collected by the device provides a~     unique look at the electrophysiological parameters of each patient's heart.~   "
141411|NCT01716338|"~     Glyburide is a medication that has been safely used for several decades to treat non-insulin~     dependent diabetes. This pilot study seeks to evaluate whether glyburide, administered at the~     lowest dose (1.5 mg/dL daily) to healthy (non-diabetic) subjects is safe both physically and~     cognitively. The investigators are hopeful that the results of this study will provide the~     necessary foundation to evaluate this medication's use on a larger scale to determine the~     feasibility of using glyburide in soldiers either prophylactically or for the treatment of~     brain injury.~   "
141412|NCT01716325|"~     The purpose of the study is to establish and clinically evaluate a new approach to treating~     obesity by using information and communication technologies (ICT). A mobile environment and~     organizational interventions to improve the process of an integrated treatment of people with~     obesity will be identified, developed, introduced and clinically evaluated.~   "
141413|NCT01716312|"~     Background:~        -  Systemic Lupus Erythematosus (SLE or lupus) is an autoimmune disease, which means the~          body's immune system mistakenly attacks healthy tissue resulting in inflammation and~          tissue damage. SLE can involve almost any organ and its symptoms can range in severity~          from mild to life-threatening; symptoms also vary from person to person. Current~          treatments for lupus are not effective for some people. Medications used to treat lupus~          can have serious side effects.~        -  Omalizumab is a drug that has been used to treat severe allergic asthma. It helps to~          prevent allergic reactions by reducing some antibodies in the blood. These antibodies~          are also present in some people with Lupus. Researchers want to see if omalizumab is a~          safe and effective treatment for people with Lupus.~      Objectives:~      - To test the safety of omalizumab for people with lupus.~      Eligibility:~      - Individuals at least 18 years of age who have moderately active Lupus even with standard~     treatments.~      Design:~        -  Subject screening will take place at the NIH Clinical Center and will include a medical~          history, a physical exam, blood and urine laboratory tests, an assessment of Lupus~          disease activity. Some participants may require some additional testing. All eligible~          persons who are interested in enrolling will be asked to come back to the NIH within 2~          weeks to begin the study.~        -  The study will be conducted in three phases, with a total of 15 study visits over 38~          weeks. Two visits will be overnight hospital stays. The rest will be outpatient visits.~          During each visit the participants will be monitored by doing a physical exam,~          assessment of their lupus disease activity, review of any treatment related side~          effects, blood and urine testing.~        -  For the first phase, participants will have infusions (under their skin) of either~          omalizumab or a placebo. They will have an overnight hospital stay for the first~          infusion and then an outpatient safety monitor visit 2 weeks after. If subjects safety~          measures are good they will return in 2 weeks and receive the second dose. They will~          then get three more doses every 4 weeks which will be given during outpatient visits to~          the NIH.~        -  In the second phase, which begins at the 16th week of the study, all participants will~          receive omalizumab. This means that subjects who had been getting omalizumab will~          continue receiving it and subjects who had been receiving the placebo will now begin~          getting omalizumab. They will have an overnight hospital stay for this infusion and will~          return in 2 weeks for a safety monitor visit. If subjects safety measures are good they~          will return in 2 weeks and receive the next dose. They will then get three more doses~          every 4 weeks which will be given during outpatient visits to the NIH.~        -  The third phase will be a final series of visits which will take place at week 32 and~          week 36. During these visits subjects will have a physical exam which includes disease~          activity assessment, blood and urine tests. No medication will be given during these~          visits.~        -  All subjects will be given information, instruction and medications for possible~          allergic reactions to omalizumab.~        -  Throughout the study other tests and procedures will be performed as needed.~   "
141414|NCT01716299|"~     The primary objective of the study is to assess whether an improved MSF HIV diagnostic~     algorithm which includes a simple and easy to perform confirmation test has significantly~     better positive predictive value than WHO recommended RDT testing algorithms that do not~     include confirmatory testing.~   "
141415|NCT01716286|"~     The aim of the current study was to investigate the effect of a low fat meal in comparison to~     a low fat meal dosed with the fatfree essence of olive oil.~   "
141416|NCT01716273|"~     How effective is sugar in reducing the debriding of sloughy, necrotic or infected exudating~     wounds compared with standard treatment?~   "
141417|NCT01716260|"~     This research is intended to study the efficacy of chloroquine (CQ) and primaquine (PQ) for~     Plasmodium vivax (P.vivax) infection, and also to study the recurrence rate among patients~     with P.vivax malaria on standard doses of CQ and PQ. For this study, PQ will be withheld for~     28 days so as to study the efficacy of CQ alone.~      This study will assess whether CQ is still effective against P.vivax or whether there are~     resistant P.vivax strains in Bhutan.~   "
141418|NCT01716247|"~     The purpose of this study is to determine if Contrast Enhanced Spectral Mammography (CESM)~     will be able to detect smaller/earlier breast cancers as well as breast MRI can.~   "
141419|NCT01716234|"~     The purpose of this dose-escalation study is to evaluate the pharmacokinetics, safety, and~     tolerability of oral posaconazole in immunocompromised children with neutropenia or expected~     neutropenia.~   "
141420|NCT01716221|"~     The purpose of this study is to document the clinical effects of bupropion and citalopram in~     a single subject with Friedreich Ataxia.~   "
141421|NCT01716208|"~     It has been shown that many patients with lymphoma or chronic lymphocytic leukemia (CLL)have~     low levels of complement. Several drugs have been approved by the Food and Drug~     Administration (FDA) for use in this cancer. However, these drugs are often used as~     combination therapies which means two or more drugs are part of the treatment. Many people,~     especially elderly patients, cannot put up with the use of multiple drugs because of the side~     effects.~      The main purpose of this study is to see if patients respond to therapy with human plasma~     (known as fresh frozen plasma or FFP) and ofatumumab. Another purpose of the study is to find~     out if this therapy will increase chances of getting rid of leukemia. This study will also~     look at the levels of complement in your blood. The levels of complement may allow better~     understanding of whether increasing the levels of complement by giving FFP may help control~     leukemia.~   "
141422|NCT01716195|"~     The purpose of this study is to determine whether human papillomavirus (HPV)-positive head~     and neck cancer can be treated with a less aggressive regimen of radiation therapy and~     chemotherapy (paclitaxel) after initially receiving two cycles of chemotherapy~     (carboplatin/paclitaxel).~   "
141423|NCT01716182|"~     This is a post-marketing, on-label Efficacy, Effectiveness and Safety Study designed in a~     Multicenter, Randomized, Prospective format. This study compares two spinal fusion~     procedures, Transacral Interbody Fusion and Transforaminal Lumbar Interbody Fusion (TLIF).~     Enrollment period will be approximately 12-18 months; each Principal Investigator/Study~     Center will be expected to enroll up to 20 subjects. The protocol requires approximately 7~     subject visits to the study center from screening through the final follow-up visit.~   "
141424|NCT01716169|"~     The purpose of this study is to test the effectiveness of Helicoll (a collagen wound~     dressing) in treating chronic and non-chronic wounds of recessive dystrophic epidermolysis~     bullosa (RDEB) patients. Helicoll will be compared to standard wound dressings.~   "
141425|NCT01716156|"~     This study will compare two different durations of treatment with grazoprevir (MK-5172) in~     combination with ribavirin (RBV) in treatment-naïve non-cirrhotic interferon-eligible~     interleukin 28b CC (IL28B CC) genotype participants with genotype 1 (GT1)-positive chronic~     hepatitis C (CHC). Participants will be randomized to receive 12 or 24 weeks of combination~     therapy.~   "
141426|NCT01716143|"~     The purpose of this study is to determine whether left atrium substrate based ablation plus~     circumferential is effective in the treatment of persistent and long-standing atrial~     fibrillation.~   "
141427|NCT01716130|"~     To assess the acceptance of the Fluzone Intradermal (ID)vaccine in adults and vaccine~     administrators in the United States. Patients completed 2 surveys, one immediately~     post-vaccination and one seven days later, that documented demographics and assessed their~     injection pain, injection anxiety, speed of injection, overall satisfaction, and preference~     for next year's vaccine. Vaccine administrators completed one survey assessing ease of~     vaccine preparation and administration, time required to administer, and safety/risk of~     needle stick injury for patient and administrator.~   "
141830|NCT01710839|"~     To see if Lucentis 0.5mg combined with Targeted Pan Retinal photocoagulation will decrease~     the total number of intravitreal injections in a year for ischemic central retinal vein~     occlusion, hemi-retinal vein occlusions and branch retinal vein occlusions compared to~     standard of care~   "
141428|NCT01716117|"~     This clinical research study is designed to determine safety and effectiveness of the Surpass~     Flow Diverter (Surpass System), an investigational device developed to treat wide neck, large~     or giant intracranial aneurysms. An intracranial aneurysm is a bulge in the wall of a blood~     vessel in the brain. The bulge is caused by a weakening of the vessel wall. If left~     untreated, the bulge may continue to grow larger and ultimately the vessel may break open~     (rupture), resulting in serious bleeding into or around the brain. The information collected~     from this study will be used to evaluate how well patients do when treated with the Surpass~     System both immediately after treatment of an aneurysm and over a long period of time (5~     years).~   "
141429|NCT01716104|"~     The purpose of this study is:~        -  To assess safety of Afalaza drug within 12 months in patients with symptoms of benign~          prostatic hyperplasia and risk of progression.~        -  To assess efficiency of Afalaza drug within 12 months in patients with symptoms of~          benign prostatic hyperplasia and risk of progression.~   "
141430|NCT01716091|"~     The investigators hypotheised that irrigating the abdominal cavity with saline at the time of~     cesarean delivery will increase Gastrointestinal System Disfunction without maternal~     infectious morbidity(especially febril morbidity).~   "
141431|NCT01716078|"~     The purpose of this study is to determine the conducting ability of distal extremity nerves~     after a supraclavicular brachial plexus nerve block (with local anesthetic) has been placed~     at a more proximal location in the upper extremity.~   "
141432|NCT01716065|"~     The purpose of the study is to determine whether the type of anesthesia during breast cancer~     surgery has any impact on the way a patient's immune system functions for a brief period~     after surgery. If the investigators find that one type of anesthesia versus the other is more~     beneficial to a patient's immune system, then the investigators may use this information to~     design a larger study to exam the effect of anesthesia better.~   "
141433|NCT01716052|"~     The purpose of this study is to determine in a randomized trial whether it is possible to~     decrease the discomfort of mammography by using the analgesic ibuprofen, or by using a~     scripted, supportive text informing patients about mammography.~   "
141434|NCT01716039|"~     Assess the body's reaction to dose-response relationship for the adalimumab/Methotrexate~     interaction in subjects with moderately to severely active ulcerative colitis.~   "
141435|NCT01716026|"~     The purpose of this protocol is to determine wether the initial protocol in the treatment of~     subfoveal choroidal neovascularization associated to High Myopia with bevacizumab~     intravitreal injections is more effective when using 3 doses vs using 1 single dose in the~     load period~   "
141436|NCT01716013|"~     To demonstrate that BondEase™ and conventional wound closure devices (CWCD) are the same in~     terms of cosmesis (appearance) of the repaired wound when these devices are used for closure~     of surgical and traumatic wounds .~      To demonstrate safety of BondEase™.~   "
141437|NCT01716000|"~     This study will compare two investigational techniques for measuring how vaginal gels spread~     and coat the vagina. This study will also explore the experiences and opinions of women using~     this vaginal gel. We want to understand how the characteristics of a gel, such as a gel's~     thickness or consistency, affect how the gel spreads and feels in the body. We hope to use~     the information we learn from this study to develop future vaginal gels that could be~     combined with medications and used to slow down or stop the spread of sexually transmitted~     infections.~   "
141438|NCT01715987|"~     Nucleotide anti-viral analogues, including adefovir and TDF, have demonstrated kidney~     toxicity in HIV/HBV co-infected patients and HBV mono-infected European patients.~     Investigators suspected similar kidney proximal tubular injury can also occur in HBV mono~     infected Asian patients receiving TDF treatment.~   "
141439|NCT01715974|"~     The purpose of this study is to determine whether in Assisted Reproductive Technologies the~     treatment with G-CSF, a growth factor working on stem cells, may improve the pregnancy rate~     and pregnancy outcome in patients experiencing recurrent implantation failure in IVF cycles.~   "
141440|NCT01715961|"~     This clinical trial is a multicentric prospective study to assess the clinical and prognostic~     value of sarcopenia in patients older than 70 years with diffuse large B-cell lymphoma.~   "
141441|NCT01715948|"~     People with single-sided deafness (SSD) have significant hearing loss in one ear and normal~     or near normal hearing in the other ear. Those living with SSD experience several~     communication difficulties, particularly when listening to speech in the presence of~     background noise. This problem is worse in situations where the noise is on the side of the~     good ear and the speech is on the side of the poor ear.~      The Bone-anchored hearing device (BAHD) and the Contralateral Routing of Signals (CROS)~     hearing aid are two intervention methods designed to improve hearing in people who have~     significant hearing loss in one ear only. The BAHD is a surgically implanted device which~     also includes an external processor; sounds from the poor ear are transmitted to the good ear~     through skull vibrations. The CROS does not involve surgery; instead a hearing aid is fitted~     behind each ear, and the sounds on the side of the poor ear are wirelessly transmitted to the~     good ear.~      The majority of previous studies comparing the BAHD to the CROS have used older CROS models~     with basic technology and a wire along the neck to send sounds from the poor ear to the good~     ear. There is a lack of studies comparing newer digital wireless CROS hearing aids to the~     BAHD. The current research will compare the effect of the BAHD and CROS hearing aid on speech~     perception scores when listening to speech in quiet and in noise. The research will also~     investigate participants' reported benefits with each device during everyday situations. In~     order to compare the BAHD and CROS, individuals who already have been implanted with a BAHD~     will be given a trial period with a new wireless digital CROS hearing aid.~      The research hypothesis states that the CROS hearing aid will be as equally beneficial or~     greater than the BAHD in improving hearing and participant benefit. If the findings support~     the hypothesis that the CROS offers just as much benefits as the BAHD, or is an even better~     alternative, more individuals with SSD may choose to avoid surgery and decide to receive a~     CROS hearing aid instead.~   "
141442|NCT01715935|"~     Disease and Stage: Metastatic and locally advanced clear cell renal carcinoma~      An open-label, exploratory, single-arm, multicenter trial.~      Everolimus will be administered orally, once daily, for 6 weeks followed by a 1-week rest~     period prior to nephrectomy.~      Two to four weeks after surgery, everolimus will be reintroduced only for metastatic patients~     until disease progression, unacceptable toxicity, withdrawal of patient consent, or other~     stopping rules are met.~   "
141443|NCT01715922|"~     The aim of the trial is to demonstrate that in a sub-Saharan African setting, the association~     of:~        1. Oral treatment : high dose of fluconazole (1600mg/d) associated with flucytosine (100~          mg/kg/j) as induction therapy~        2. lumbar punctures to control intracranial pressure~      can decrease mortality rate below 35% at 10 weeks.~      This is a non-randomized open label pilot study, with standardized management of~     cryptococcoses meningitis and follow-up in Burundi and Ivory Coast. A total of 41 patients~     will be enrolled.~   "
141444|NCT01715909|"~     This open-label, randomized, adaptive, 2-arm, multicenter study will evaluate the~     pharmacokinetics and pharmacodynamics of oseltamivir (Tamiflu) in immunocompromised children,~     less than (<) 13 years of age, with confirmed influenza infection. Participants will be~     randomized to receive either the standard dose or triple dose of oseltamivir orally daily for~     a minimum of 5 days and up to 20 days. Infants <1 year of age will be randomized to the~     standard dose arm only.~   "
141445|NCT01715896|"~     The primary objectives of this study is to explore the efficacy of mavrilimumab compared with~     golimumab in the treatment of adult subjects 18-80 years of age with moderate-to-severe~     active rheumatoid arthritis (RA) who have an inadequate response to one or more conventional~     disease-modifying anti-rheumatic drugs (DMARDs) and/or one or two anti-tumor necrosis factor~     (TNF) agents (excluding golimumab) for efficacy or safety reasons.~   "
141446|NCT01715883|"~     This is a Phase IIA observational nonrandomized pilot investigation to evaluate the safety~     and efficacy of Sodium Nitrite administration for the reduction of PGD in patients undergoing~     lung transplant. The study will enroll 8 subjects, undergoing lung transplant at the~     University of Pittsburgh Medical Center (UPMC).~   "
141447|NCT01715870|"~     The study population will be selected from the Epidemiological study on the prevalence of~     Age related Macular Degeneration in Portugal (Protocol N. CC-01-2009) where retinal~     photographic grading (current gold standard for AMD assessment) was performed to confirm AMD~     diagnostic. This study provides a population-based sample in which precise and contemporary~     information on the frequency of nutritional and lifestyle risk factors will be collected,~     enabling to evaluate whether the separate and/or joint effects of these factors, if found~     significant, are likely to have a major public health impact in terms of AMD.~   "
141448|NCT01715857|"~     Until recently, there was a lack of understanding and consensus among Chinese~     anesthesiologists how they should practice general anesthesia with volatile anesthetics,~     since there was no standard of inhalation practice. In August 2011, the Anesthesiology branch~     of the Chinese Medical Association launched the first version of Chinese Consensus of~     Standard Clinical Practice for Inhalation Anesthesia (Consensus) in order to standardize the~     practice in China.~      The proposed registry is aimed to evaluate the current inhalation practice one year after the~     Consensus has been released, and related patient outcome. This registry evaluated sevoflurane~     anesthesia, including screening, induction, maintenance, emergence, and follow-up within 24~     hours post-operation.~   "
141449|NCT01715844|"~     In people who develop asthma after the age of 12 and who are also overweigh, there can be an~     increased burden of asthma symptoms, more flare-ups, and poorly-controlled asthma when~     compared to normal weight asthmatics. Certain factors are more abundant in the blood of~     individuals who are obese. One such factor is derived from the metabolism of an amino acid~     found in your diet, which is known as L-arginine (Amino acids are most commonly known as the~     building blocks of proteins, the same as the proteins found in food). This factor is called~     asymmetric dimethylarginine or ADMA. The balance of L-arginine to ADMA may be important to~     the health of subjects with asthma. The balance between L-arginine and ADMA plays an~     important role in producing nitric oxide (NO) in the airways. NO is normally produced in the~     lung and plays a major role in maintaining airways open and functioning normally. Our~     research has shown that in subjects with asthma who are overweight and developed asthma later~     in life, the combination of low L-arginine and high ADMA, may lead to lower NO levels. We are~     asking participants in this study to take L-citrulline, which is converted to L-arginine by~     your body, as a supplement for a period of one week. We anticipate that L-citrulline will~     restore NO levels in the airways, by increasing the ratio of L-arginine to ADMA~   "
141450|NCT01715831|"~     This multicenter, open-label, single-arm extension study will evaluate the long-term safety~     of tocilizumab (RoActemra/Actemra) in participants with RA. Participants who have completed~     the MA21488 (NCT00810199) core study and the ML21530 (NCT00754572) study and who could~     benefit from the study drug, according to the opinion of the investigator, will receive 8~     milligrams per kilogram (mg/kg) of intravenous (IV) tocilizumab every 4 weeks. The~     anticipated time on study treatment is 104 weeks.~   "
141451|NCT01715818|"~     This randomized, double-blind, placebo-controlled, parallel group, multicenter study will~     evaluate the potential of aleglitazar to reduce cardiovascular risk in patients with stable~     cardiovascular disease and glucose abnormalities. Patients will be randomized 1:1 to receive~     either aleglitazar 150 mcg orally daily or matching placebo.~   "
141452|NCT01715805|"~     The objective of this study is to evaluate the efficacy, safety and tolerability of~     cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with MDD~   "
141453|NCT01715792|"~     This study aims to assess the risk of solid organ transplant (SOT) rejection following~     vaccination with Pandemrix™ and/ or seasonal influenza vaccination.~   "
141454|NCT01715779|"~     The objective of this observational study is to characterize long-term (5 years post event)~     clinical outcomes in patients who experienced a thromboembolic event (TEE) during~     participation in the GSK ENABLE clinical trials.~      Patients eligible for the study are patient who experienced a TEE during participation in the~     ENABLE trials. Each included patient will be followed for a period of 5 years from the date~     of their first TEE. Demographic and clinical characteristics will be collected for the index~     date (time of TEE) and every sixth month during the follow-up period, information will be~     collected for the outcomes of interests: mortality, new TEE, hepatic decompensation,~     evaluation for liver transplant and result of evaluation, and liver transplantation.~      All information will collected by medical record review.~   "
141455|NCT01715766|"~     The purpose of the study is to learn about the causes of different types of pain that can~     occur in people who have had an amputation. By gathering information through blood tests,~     photographs, a nerve test, and questionnaires, we hope to de-code how each individual's~     special characteristics affect the type and amount of pain they experience in their amputated~     limb.~   "
141487|NCT01715337|"~     Pulmonary rehabilitation has been established as an evidence-based and recommended therapy in~     patients with chronic obstructive pulmonary disease (COPD). The aim of our study is to show a~     potential change in muscle fibre composition and in the amount of capillaries in quadriceps~     muscle from pre tob post 3-week rehabilitation. Pulmonary rehabilitation includes~     standardised exercise training, e.g. cycling and strength training for major muscle groups.~   "
141456|NCT01715753|"~     The purpose of the trial is to assess the effects of weight loss on functional status and~     lean muscle mass in frail, obese older adults (>/= 60) who participate in a 6 month weight~     reduction intervention. Participants will be randomized into one of two study arms: Weight~     Loss Control: (n = 25) subjects follow a calorie-reduction diet for a weight loss of ≥10%; or~     Weight Loss-High Protein: (n = 50) subjects follow a calorie-reduction diet for a weight loss~     of ≥10%, with a high proportion of high quality protein at each meal. Intakes of > 30g of~     high quality protein will be achieved three times a day by subjects in this group,~     predominantly all from animal sources and 60-70% of animal protein from beef. Subject~     criteria will include obese (>30 kg/m2) older adults (>60 yrs.) with mild to moderate~     functional impairment (by Short Physical Performance Battery; SPPB score >/= 4)~   "
141457|NCT01715740|"~     Urticaria is a common dermatology disease. Urticaria affects nearly 25% of the population at~     some time in their lives. Recurrent skin itch, insomnia, daily activities limitation greatly~     affect the quality of life. Some patient with chronic urticaria who had poor response to~     antihistamine may need second line medication. In United States, up to 54% chronic urticarial~     patient use oral corticosteroid to control. However, long-term use of oral steroids still~     needs to consider the impact of its side effects. Therefore, patients may seek for~     alternative medicine as an adjuvant therapy.~      It is still lack large-scale clinical trials in Traditional Chinese Medicine research of~     chronic urticarial. The aim of this study is to conduct a double-blind, randomized clinical~     trial to analyze the effectiveness of Chinese medicine in chronic urticaria and its possible~     mechanisms.~   "
141458|NCT01715727|"~     The hypothesis of the study is that the dopaminergic cell death located in the basal ganglia~     of the brain in patients with Parkinson's Disease can be detected by diffusion Magnetic~     Resonance Imaging, specifically by diffusion kurtosis imaging. The preliminary result was~     published in Radiology 2011. The current study proposed to investigate the following issues:~        -  validation of diagnostic sensitivity and specificity~        -  differential diagnosis capability between PD and PD+ syndrome~        -  prognosis capability~      In the first year, patients with Parkinson's disease will be recruited from the outpatient~     clinics of movement disorders in ChangGung memorial hospital Linkou, Taiwan. The diffusion~     parameters in basal ganglia will be compared with a group of healthy controls. In the second~     year, patients with progressive supranuclear palsy and patients with multiple system atrophy~     will be recruited for assessment of differential diagnosis. The patients with Parkinson's~     Disease will return for assessment of disease severity and in the third year, for the outcome~     evaluation.~   "
141459|NCT01715714|"~     Patients with coronary artery disease requiring coronary artery bypass grafting (CABG) are at~     risk for postoperative complications after surgery. The StaRT-CABG trial is the first~     large-scale (2,630 patients) that will investigate whether an additional treatment with~     statins (lipid-lowering medication) in high doses before CABG surgery can reduce the~     incidence of major post-surgery complications including death, myocardial infarction and~     stroke. The StaRT-CABG trial will be recruiting patients from 8 cardiac surgery centres in~     Germany and is expected to provide relevant clinical data on the efficacy of this novel~     treatment in order to optimize the care for all patients undergoing CABG.~   "
141460|NCT01715701|"~     This study is designed to assess:~        -  The impact of preoperative multilevel thoracic paravertebral nerve blockade compared to~          intercostal nerve blockade performed at the end of surgery on the intensity of~          postoperative pain in subjects having a Patient Controlled Analgesia (PCA) device as~          their primary analgesic modality.~        -  The incidence of chronic pain at 6 months following video-assisted thoracic surgery.~        -  The impact of preoperative multilevel paravertebral nerve blockade on patients' quality~          of life at 6 months following surgery compared to intercostal nerve blockade and to a~          control group using PCA alone.~      Hypothesis:~        1. The basic hypothesis of this study is that preoperative thoracic multilevel~          paravertebral nerve blockade and multilevel intercostal nerve blockade performed at the~          end of surgery will provide superior postoperative analgesia and lower opioid~          consumption compared to PCA alone during the first 24 hours following surgery.~        2. Preoperative thoracic multilevel paravertebral nerve blockade will reduce the incidence~          of chronic pain at 6 months following surgery.~        3. Preoperative thoracic multilevel paravertebral nerve blockade and multilevel intercostal~          nerve blockade performed at the end of surgery will shorten the length of stay in the~          intermediate intensive care unit and shorten the hospital stay.~        4. Preoperative thoracic multilevel paravertebral nerve blockade and multilevel intercostal~          nerve blockade performed at the end of surgery will reduce postoperative pulmonary~          complications.~   "
141461|NCT01715688|"~     This study is designed to compare the efficacy of endotracheal tube cuffs pre-filled with~     alkalinized lidocaine on the:~        -  incidence of coughing during emergence of general anesthesia~        -  time needed for emergence following a desflurane-based anesthesia~        -  incidence of sore throat after extubation.~      The investigator's hypothesis is that the use of endotracheal tube cuffs pre-filled with~     alkalinized lidocaine will reduce the incidence of coughing by 50% relative to a control~     group following a desflurane-based anesthesia.~   "
141462|NCT01715675|"~     Rationale: Plant stanols are well known for their effects on lowering intestinal cholesterol~     absorption ultimately resulting in 10-15% reduced serum LDL cholesterol concentrations in~     humans. In addition we have also shown that serum triacylglycerol (TG) concentrations may be~     lowered in subjects with elevated baseline concentrations. Till now, there is little evidence~     for plant stanol effects other than improving lipid profiles. However, we have very recently~     found strong indications in ex vivo models using isolated human peripheral mononuclear blood~     cells (PBMCs) from healthy volunteers that plant stanols have the capacity to improve immune~     function. More into detail, plant stanols shifted the differentiation of naive T-cells into~     the Th1 direction by activating a specific receptor present on the Antigen presenting cells~     (APCs) and T-cells. This effect might ultimately be helpful in situations in which the~     Th1/Th2 cell balance is disturbed into a Th2 over-responsiveness. By activating the Th1~     response, the disturbed balance may be restored. This is for example a possibility in the~     treatment or prevention of asthma, food allergies or HIV in susceptible subjects. In~     addition, very recently (MEC 08-3-051) in a pilot study we also showed these ex vivo Th1~     stimulating effects of plant stanols specifically in PBMCs isolated from asthma patients, as~     said, a condition characterized by a Th2 dominant immune response.~      Objective: The major research objective is to prove that the consumption of plant stanol~     ester enriched yogurts can improve immune function in vivo in asthma patients.~      Study design: A double-blind randomized placebo-controlled human intervention study in which~     90 patients with clinically proven asthma will participate: 45 in the intervention group~     receiving plant stanol yoghurt and 45 in the control group receiving a control yoghurt~     without added plant stanols. At the end of the run-in period as well as at the end of the~     experimental period blood will be sampled to isolate PBMCs. These cells are used to evaluate~     effects on cytokine production, phagocytic capacity of neutrophils, and the activity of NK~     cells. In addition, the golden standard to show improvements in immune function is by showing~     an elevated Immunoglobulin response to a vaccine. Therefore, during the experimental period~     all subjects receive a vaccination against Hepatitis A Virus. After 1, 2, 3, and 4 weeks~     blood will be sampled to monitor specific immunoglobulin titers to HAV.~      Study population: 90 people with clinically proven asthma, who are not carrier of hepatitis~     A, B or C and have not been vaccinated against hepatitis A in the past. Also, these~     participants do not have any other immune-related pathology Main study parameters/endpoints:~     primary: Specific anti-HAV antibody titers after vaccination; secondary: Phagocytic capacity~     of neutrophils; NK-cell activity; Th1 and Th2 cytokine production profiles by PHA stimulated~     PMBCs.~      Nature and extent of the burden and risks associated with participation, benefit and group~     relatedness: During the study, 9 blood samples (each 20 or 50 mL) will be taken. Total time~     investment for the subjects will be 160 min. Occasionally, a heamatoma or bruise can occur~     during venipuncture. After the vaccination a heamatoma or a sore arm can occur. These side~     effects should disappear within 4-5 days. Other common side effects related to the~     vaccination are headache, loss of appetite, and fatigue, which usually will disappear within~     24 hours.~      The results of this study will show whether consumption of plant stanol enriched yogurts is~     able to restore the disturbed th1/Th2 balance in asthma patients. Ultimately, this is~     expected to reduce asthmatic exacerbations, as the Th2 dominant immune response seems causal~     to asthmatic symptoms, however these clinical improvements are not verified in this~     relatively short term intervention study.~   "
141463|NCT01715662|"~     This is a pilot randomized controlled trial to assess the feasibility of a home-based~     Nintendo Wii Fit program (Wii.n.Walk) to improve walking capacity in older adults with a~     lower limb amputation. Twenty four individuals with a unilateral below-knee or above-knee~     amputation will be randomly allocated to Wii.n.Walk or control arm. The Wii.n.Walk arm will~     receive aerobics, weight-shifting, balance games and exercises using the Wii Fit gaming~     technology. The control arm will receive cognitive computer games and exercises using Wii Big~     Brain Academy Degree program. Both groups will receive the intervention for 40-minute~     sessions, 3x/week for 4 weeks. The interventions will be conducted in combinations of~     in-clinic group (n=3) training and individualized in-home training. Outcome measurements will~     be completed by a blinded evaluator at baseline, end of treatment, and 3 weeks after the end~     of treatment.~      Hypothesis: Our primary hypothesis is that Wii.n.Walk is feasible. Our primary clinical~     hypothesis is that participants in the Wii.n.Walk intervention group will experience an~     improvement in walking capacity compared to the control group. The secondary clinical~     hypothesis is that participants in the Wii.n.Walk group will experience an improvement in~     balance confidence, physical activity, number of steps taken per day, walking while talking,~     lower limb functioning, and locomotor capabilities.~   "
141464|NCT01715649|"~     Telehealth remote patient monitoring is a means of using communications technology - such as~     telephones, computers, and the Internet - to connect patients remotely with their healthcare~     team from their homes. The investigators hope to learn more about improving healthy behaviors~     and blood glucose among persons with diabetes using telehealth remote patient monitoring~     technology to connect directly with nurse care coordinators.~      The purpose of this study is to evaluate a process for improving blood glucose and healthy~     behaviors among people with type 2 diabetes using telehealth remote patient monitoring~     technology with nurse care coordinators. Some of the people in this study will work with a~     nurse care coordinator who will review your blood glucose weekly and call you at home every~     month for 3 months, while some of the people in this study will simply receive their normal~     care. At the end of the study, every participant will be asked questions about how they feel~     about their health care.~   "
141465|NCT01715636|"~     This study aims to describe the safety, tolerability and adherence to the coformulated~     anti-HIV drug tenofovir-emtricitabine-rilpivirine (eviplera) when given to men who have sex~     with men (MSM) following an actual or potential sexual exposure to HIV. This biomedical~     intervention is known as nonoccupational post-exposure prophylaxis (NPEP). Patients receive~     NPEP if they meet the criteria outlined in the 2007 National Australian NPEP Guidelines.~     Three or two anti-HIV drugs are administered for 28-days depending on the severity of the the~     assessed HIV acquisition risk. In this study eviplera would constitute 3-drug NPEP.~     Tenofovir-emtricitabine (truvada) a component of eviplera has been used in NPEP at SVH since~     2006.~      This is a multi site, prospective, open-label, non-randomised trial. Participants will be MSM~     who present at the various recruitment sites requesting NPEP. Initially, 50 eligible~     participants will be assigned to receive eviplera 25mg once daily taken with food for 28-days~     according to established Australian guidelines for the use of 3-drug NPEP. There will be 7~     visits over a 12-week period. Follow-up post NPEP is for 8 weeks. If an interim analysis~     demonstrates acceptable safety, it is proposed to seek ethics approval to increase the~     samples size to 100 patients to gain more accurate information on regimen completion rate and~     on-drug adherence.~      The primary study objectives are:~        1. To describe the safety of 28 days of NPEP using co-formulated FTC-RPV-TDF~        2. To describe the tolerability of 28 days of NPEP using FTC-RPV-TDF~        3. To describe on-drug adherence and regimen completion rates of 28 days of NPEP using~          FTC-RPV-TDF~   "
141466|NCT01715623|"~     The investigators previously showed that both antibody class switching (from IgM to IgG, IgA~     or IgE) and antibody secretion are controlled by a polymorphic 3' regulatory region (3'RR)~     of the immunoglobulin heavy chain (IgH) locus. Alleles of the 3'RR have shown influences on~     the severity and progression of IgA nephropathy (IgAN) (with an over-representation of the B~     allele among patients with severe kidney IgA deposits). Allele B also constitutes a risk~     factor for celiac disease, herpetiform dermatitis, psoriasis and rheumatoid arthritis. Since~     the 3'RR now appears as a crucial regulator of Ig production, we wish to check whether its~     genetic polymorphism might influence not only the occurrence of immunopathologic processes~     involving class-switched antibody deregulated production but also the severity of such~     diseases or the time course of their progression. We wish to focus on two conditions~     involving class-switched antibodies: on one hand the severe forms of IgE hypersensitivities,~     and on the other hand a disease involving pathogenic IgA and for which the prognosis is~     currently very difficult to predict at the onset of the disease: Henoch-Schonlein purpura~     (HSP).~      Regarding hypersensitivities, the diversity of their clinical manifestations prompt us to~     focus on homogeneous groups of patients and we thus wish to concentrate on two groups of~     patients who are frequently referred to the hospital: severe allergies to Hymenoptera venoms~     and severe food allergies related to peanut allergens sensitization. These groups will be~     built by considering multiple clinical criteria (clinical history, severity of the~     manifestations, positive skin tests, and positive oral provocation tests for peanut~     allergens…) and biological criteria authenticating the mechanisms of the disease (high~     specific serum IgE, demonstration of specific basophil activation by the allergen…).~      In parallel to the study in patients, we will include a large cohort of healthy controls (400~     individuals), in order to be able to decipher whether correlations can be seen between:~        -  IgH 3'RR genotypes~        -  The serum accumulation of the various Ig classes, including IgG subclasses, IgA (which~          are sometimes depicted as protective, sometimes as tolerogenic and anti-inflammatory)~          and IgE (highly pro-inflammatory and responsible for hypersensitivities)~        -  IgG allotypes (with 6 frequent IgG haplotypes known in human and previously reported as~          correlated with varying levels of IgG and IgE production in normal individuals).~   "
141467|NCT01715610|"~     This study aims to look at the necessity for prescribing antibiotics post-drainage of~     peritonsillar abscesses (PTA). This will be a single-blinded randomized-control trial with~     two arms - patients receiving placebo versus those receiving a seven day course of oral~     Amoxicillin-Clavulanic acid. The main objective measure will be to assess if there is~     resolution of the peri-tonsillar abscess and there has been no reaccumulation. Patients will~     be blinded to whether they receive placebo or amoxicillin-clavulanic acid. Patients will be~     phoned after 7 days to assess if their symptoms have resolved via an over the phone~     questionnaire. Anaerobic and aerobic cultures will be obtained.~   "
141468|NCT01715597|"~     The investigators want to know whether the intravenous ascorbic acid would reduce the blood~     loss during laparoscopic myoma surgery. The investigators randomized patients into~     intravenous ascorbic acid group and placebo group and examined the blood loss in both groups.~   "
141469|NCT01715584|"~     It is controversial whether or not patients whose Renin Angiotensin System is blocked for the~     treatment of hypertension suffer increased risk when undergoing surgery and anaesthesia.~      The investigators wish to test the hypothesis: Blockade of the Renin Angiotensin System~     causes altered dose response under general anaesthesia in a dose dependant manner. The~     investigators wish to look for altered responses across the usual anaesthetic dosing range as~     measured by blood pressure and heart responses.~   "
141470|NCT01715571|"~     The primary objective of this study is to assess the safety, acceptability, and satisfaction~     of penile vibratory stimulation in treatment of erectile dysfunction (ED). The secondary~     objective is to demonstrate subjective physiological response (erection, rigidity, orgasm)~     after four weeks of frequent device use and the satisfaction of penile erection and sexual~     intercourse with partner.~   "
141471|NCT01715558|"~     The purpose of the study is to demonstrate that reduction of unnecessary pacing provided by~     RYTHMIQ algorithm programed to ON in a pacemaker is associated with better clinical outcomes~     in bradycardia target population.~   "
141472|NCT01715545|"~     The purpose of this study is to explore a method to identify the viability of day-3 poor~     quality embryos~   "
141590|NCT01713985|"~     Up to 20 subjects will be enrolled and randomly assigned to one of two treatment groups.~     Group A will receive Ultherapy™ on the right side of the face and neck and Thermage on the~     left side. Group B will receive Thermage on the right side of the face and neck and~     Ultherapy™ on the left side. Follow-up visits will occur at 90 and 180 days post-treatment.~     Study images will be obtained pre-treatment, immediately post-treatment, and at each~     follow-up visit.~   "
141473|NCT01715532|"~     Primary Outcome Measures:~      - To compare the progression free survival(PFS) in patients with unresectable hepatocellular~     carcinoma(HCC) treated with transcatheter arterial chemoembolization(TACE) with or without~     Huachansu, and the correlation between PFS and expression of peripheral Na+/K+-ATPase α3~     family.~      Secondary Outcome Measures:~      - To compare the overall survival(OS), objective response rate(ORR), and side effects of~     treating HCC with TACE plus Huachansu or TACE alone.~      Exploratory Outcome Measures:~      - To evaluate the correlation between prognosis and expression of peripheral Na+/K+-ATPase α3~     family.~   "
141474|NCT01715519|"~     The purpose of this study is to determine whether vilazodone is effective in the treatmen of~     Posttraumatic Stress Disorder (PTSD)and co-morbid mild or more depression.~   "
141475|NCT01715506|"~     This is a single-blinded controlled cluster-randomized intervention trial recruiting staff~     from 24 NHs in three counties in the region of Western Norway, randomly selected from the~     total NH population in the region. A cluster is defined as a working ward of a larger NH,~     without shared facilities or staff. The 24 NHs are randomized into two groups, for~     intervention (12) and control (12). One department in each is selected for intervention and~     data collection will take place also in one department in each of the NHs in the control~     group. Hence the analyzed units (clusters) are NH departments. The educational intervention~     (EI), Relation Related Care (RRC), consists of a two-day seminar and one hour monthly~     guidance for six months. A seven-month educational intervention will be performed, and due to~     ethical issues the control group will receive the same intervention after the second~     follow-up. Effects will be measured on resident and care staff level at baseline before~     randomization, after the intervention (7 months) and at follow-up (7 months later) of the~     intervention group.~   "
141476|NCT01715493|"~     The aim of this study was to assess the effectiveness for small airway inflammation of 4~     weeks lysozyme administration in Chronic Obstructive Pulmonary Disease (COPD) and/or asthma.~   "
141477|NCT01715480|"~     The overall purpose of this study is to obtain a better understanding of the biological~     response of red blood cells to sulforaphane contained in fresh broccoli sprouts that have~     been put through a blending process. This study will use commercially available fresh~     broccoli sprouts certified by Brassica Protection Products LLC (BroccoSprouts®). This product~     can also be purchased at some local grocery stores in the produce section. It is believed~     that NRF2, a transcription factor encoded by the NFE2L2 gene, plays a role in the regulation~     of defense against oxidative stress. The detrimental accelerated breakdown of sickle cell~     disease (SCD) red blood cells (SS RBC) is partially due to reduced anti-oxidative capacity.~     Previous analysis of SS RBC microRNAs revealed that a reduced level of NRF2, the master~     regulator of anti-oxidative stress capacity, contributes to reduced resistance to oxidative~     stress and increased hemolysis; NRF2 also induces fetal hemoglobin (HbF), which is known to~     prevent SS RBC sickling.~      First, erythroid progenitors from normal and SCD subjects will be tested ex-vivo to find out~     how sulforaphane, a natural NRF2 activator, affects the oxidative stress capacity, HbF~     expression, and microRNA expression of red cells.~      Second, a pilot clinical trial will be conducted to determine the safety and physiological~     effects of 3 weeks of daily consumption of broccoli sprout homogenate in a cohort of Hb~     SS/SB0 thalassemia adult SCD patients. During this study, subjects RBCs will be assayed for~     changes in anti-oxidative stress capacity and microRNA composition in mature SCD red blood~     cells.~   "
141478|NCT01715467|"~     This observational study will prospectively collect data on treatment options,~     patient/investigator satisfaction, requirement for retreatment or additional treatment, and~     long-term outcomes of 3 treatment modalities(XIAFLEX, fasciectomy, or fasciotomy/needle~     aponeurotomy) in patients with Dupuytren's contracture. In addition, this study will provide~     additional health economics and utilization data.~   "
141479|NCT01715441|"~     The aim of this multicenter randomized phase II trial is to determine the efficacy of~     sorafenib and irinotecan combination versus irinotecan monotherapy or versus sorafenib~     monotherapy in metastatic colorectal cancer patients with KRAS mutated tumors after failure~     of all active drugs known to be effective.~   "
141480|NCT01715428|"~     Incretin-based therapies have shown significant effects beyond those on glucose metabolism.~     We aim in the present study to evaluate the effects of liraglutide on several~     cardio-metabolic risk markers.~   "
141481|NCT01715415|"~     The purpose of this study is to evaluate the safety and efficacy of ABT-450, ritonavir and~     ABT-267 (ABT-450/r/ABT-267; ABT-267 also known as ombitasvir) and ABT-333 (also known as~     dasabuvir) co-administered with ribavirin (RBV) in hepatitis C virus genotype 1 infected~     treatment-experienced adults.~   "
141482|NCT01715402|"~     The aim of this study is to reduce the length of stay after liver surgery by taking account~     of objective quantitative clinical variables, subjective qualitative clinical variables and~     non clinical variables.~   "
141483|NCT01715389|"~     This pilot intervention study will test the feasibility and acceptability and explore the~     outcomes of a primary care-based shared decision making (SDM) electronic medical record~     (EMR)-based portal that provides education, elicits and tracks patients/families' treatment~     concerns and goals, assesses symptoms and asthma control over time, and provides decision~     support to clinicians and families.~   "
141484|NCT01715376|"~     Compared with standardized western medical drug therapy, this study is mainly about whether~     the combination of standardized western medical drug therapy and Chinese medical continued~     treatment, can further decrease the rate of cardiovascular events for stable angina patients~     and change the condition of angina.~   "
141485|NCT01715363|"~     The purpose of this study is to analyze the clinical tolerance of immediate preoperative~     chemotherapy in terms of toxicity and perioperative morbidity and mortality~   "
141486|NCT01715350|"~     The investigators intend to perform exploratory evaluation of the treatment effectiveness and~     safety of PM012 Tablet of PuriMED Co., Ltd. at 2 doses in Korean patients with mild to~     moderate dementia of Alzheimer's type. To achieve this, this study aims to compare each dose~     with placebo control for the efficacy and safety to explore the clinically optimal dose of~     PM012 Tablet for therapeutic confirmatory (phase 3) clinical studies.~   "
141591|NCT01713972|"~     This phase I trial studies the side effects and best dose of dabrafenib and pazopanib~     hydrochloride when given together in treating patients with advanced malignant tumors.~     Dabrafenib and pazopanib hydrochloride may stop the growth of tumor cells by blocking some of~     the enzymes needed for cell growth~   "
141488|NCT01715324|"~     In an In Vitro Fertilization (IVF) cycle super ovulating drugs (gonadotropins) are usually~     taken to stimulate the ovaries to produce more than one egg. In Vitro Fertilization protocols~     are constantly under review in order to improve the recruitment of the follicles, which~     contain the eggs, whilst minimizing the doses of gonadotrophins required, with the ultimate~     aim of increasing the live birth rate.~      The addition of growth hormone, which is a biological hormone that can be synthetically~     produced, as a supplement to gonadotrophins in an In Vitro Fertilization cycle has been~     suggested as a way in which In Vitro Fertilization pregnancy rates may be increased.Growth~     hormone has been shown, in animal and human studies, to be important in the recruitment of~     follicles.However, to date, only a limited number of clinical studies have been performed in~     order to assess whether the addition of growth hormone can improve the probability of~     pregnancy in women undergoing ovarian stimulation for In Vitro Fertilization. As the total~     number of patients analysed in these studies was small it has not been possible to determine~     whether if there is any improvement the outcome of an In Vitro Fertilization cycle when a~     woman is given growth hormone therapy as a supplement during her treatment.~      This goal of this study is to determine the effectiveness of using growth hormone therapy as~     a supplement to the administration of gonadotropins in an antagonist In Vitro Fertilization~     protocol.~   "
141489|NCT01715311|"~     This study will compare the efficacy of indacaterol versus placebo (i.e., rescue medication~     only) and tiotropium in patients with Chronic Obstructive Pulmonary Disease (COPD) who have~     not received maintenance COPD medication for at least 12 months prior to entry (described~     hereafter as maintenance naïve, see inclusion criteria).~   "
141490|NCT01715298|"~     The study serves to determine whether the treatment of patients with stable, symptomatic~     Chronic Obstructive Pulmonary Disease (COPD) with the investigational drug NVA237 is~     efficient and safe. The efficacy and safety of the drug will be tested against a placebo~     treatment. The primary criterion to assess efficacy will be the difference between the serial~     lung function measurements of patients who have been treated for 12 weeks with NVA237 versus~     those that have received placebo treatment for 12 weeks. A serial lung function measurement~     (FEV1 testing) will be conducted and the area under the curve will be the measure for the~     ability to breathe.~   "
141491|NCT01715285|"~     The purpose of this study is to determine if newly diagnosed (within previous 3 months)~     participants with metastatic (spread of cancer cells from one part of the body to another )~     hormone-naive prostate cancer (mHNPC) who have high-risk prognostic factors will benefit from~     the addition of abiraterone acetate and low-dose prednisone to androgen deprivation therapy~     (ADT; lutenizing hormone releasing hormone [LHRH] agonists or surgical castration).~   "
141492|NCT01715272|"~     This study is designed to assess the difference between the performance of a new enema~     (TF037) against Fleet enema in distal bowel cleansing.~   "
141493|NCT01715259|"~     The purpose of this study is to determine the pharmacokinetic (how the drug concentrations~     change over time) profile of abiraterone acetate 1000 mg when administered as a single dose~     in male participants with impaired renal function compared to individuals with normal renal~     function.~   "
141494|NCT01715246|"~     The primary objective of this clinical study is to show that infants fed a standard starter~     infant formula with 2 Human Milk Oligosaccharides (HMOs) have a growth in line with infants~     fed a standard starter infant formula without HMOs.~   "
141495|NCT01715233|"~     To estimate and compare the response rates in patients treated with mDCF based on methylation~     status of CHFR.~   "
141496|NCT01715220|"~     ABSTRACT: Sublingual nitroglycerin has been advocated for the treatment of acute pain from~     suspected symptomatic cholelithiasis. There is, however, no clinical studies that validate~     its use. This study is designed to evaluate the efficacy of nitroglycerine in relieving acute~     pain of suspected biliary tract origin.~      Nitroglycerin is a potent smooth muscle relaxant used for biliary tract dilation during ERCP,~     (Chelly, J) and has been recommended for treatment of biliary colic based on anecdotal~     experience and small case reports. Nitroglycerin effect is a result of the nitric oxide~     component of the medication which acts as a smooth muscle relaxant in vascular, bronchial,~     esophageal and biliary smooth muscles. [McGowan(1936), Chelly (1979),Toyoyama (2001)] The~     typical dose of nitroglycerin is 0.4 mg given sublingually in pill form or, more recently, in~     a metered spray form. In a case series reported by Hassel (1993), positive response times~     ranged from 20 to 60 seconds with duration of action of two to twelve hours. Sublingual~     nitroglycerin is most commonly used for treatment of chest pain related to insufficient~     cardiac perfusion. It has also been noted to relieve the pain of esophageal spasms.~     Nitroglycerin has an excellent safety profile if used in patients with adequate pretreatment~     blood pressures. [Newberry (2005), Nitroglycerine (2011), Nitro (2011), Wolters (2009)] This~     study proposes to compare sublingual 0.4 mg doses of nitroglycerin to placebo for the initial~     treatment of acute pain from suspected symptomatic cholelithiasis~   "
141497|NCT01715207|"~     Marfan syndrome (MFS) is an inherited disorder of connective tissue with morbidity and~     mortality from aortic dilatation and dissection. The current standard of care is beta-blocker~     (BB) treatment and therapeutic target is heart rate. The degree of aortic dilatation and~     response to BB vary in adults with MFS. However, aortic stiffness is often present, and can~     be a predictor of aortic dilatation and cardiovascular complications. Aortic stiffness is a~     logical therapeutic target in adults with MFS.~      Transforming growth factor beta(TGF-beta) mediates disease pathogenesis in MFS and~     contributes to aortic stiffness. Cross-talk between TGF-beta system and renin-angiotensin~     system (RAS) has been demonstrated. The angiotensin receptor blocker (ARB), losartan,~     inhibits TGF-beta activity and reverses aortic wall pathology in a Marfan mouse model. In a~     small cohort study, the use of ARB therapy (losartan or irbesartan) significantly slowed the~     rate of progressive aortic dilatation in patients with MFS, after BB therapy had failed to~     prevent aortic root dilatation. In another study, angiotensin converting enzyme inhibitor,~     perindopril, reduced both aortic stiffness and aortic root diameter in patients with MFS~     taking standard BB therapy. Renin inhibitor, aliskiren, has not been studied to reduce aortic~     stiffness and attenuate aortic dilatation in patients with MFS.~      This trial is a randomized, open-label trial of 32 patients with Marfan syndrome, treated~     with 6 months of aliskiren vs. negative controls in patients with MFS under atenolol~     treatment. MRI for aortic pulsed wave velocity (PWV) and distensibility, measurements of~     central BP (CBP) and augmentation index (AIx) will be performed at the beginning and end of~     treatment. A blood drawn for serum markers of TGF-beta, extracellular matrix turnover and~     inflammation will also be performed at 0 and 6 months. We plan to determine whether aliskiren~     decreases aortic stiffness significantly more than negative controls in patients with MFS~     under atenolol treatment.~   "
141592|NCT01713959|"~     Single-center, randomized, split-body, pilot study, treatment of up to 23 subjects in two~     treatment groups. Subjects will receive two Ultherapy treatments at Day 0 with follow-ups at~     7 and 14 days post-treatment #1, and Day 28 with follow-ups are 7, 14, 30, 60, 90 days~     post-treatment #2.~   "
141498|NCT01715194|"~     We hypothesize that the use of telemedicine combined with support interventions by short~     messages, telephone calls and ambulatory visits to control CPAP treatment during the first~     month improves adherence and reduces unresolved side effects of therapy.~      The primary objective of an OSAS treatment program is to successfully implement indicated~     CPAP in the highest possible proportion of patients in order to lower the proportion of~     untreated OSAS in the population. On an individual basis, it has been shown that a longer~     duration of CPAP use is associated with better outcomes in terms of daytime functioning and~     in the control of metabolic and blood pressure effects of CPAP. For our study, we have~     therefore decided to use 2 co-primary endpoints, taking into account both aspects of~     adherence mentioned. Cardiovascular complications are a major concern in OSAS patients.~     Effective CPAP treatment has been shown to reduce surrogate measures of cardiovascular risk.~     We hypothesize that intensified efforts for CPAP adherence with telemedicine has a positive~     impact on a number of surrogate measures of the cardiovascular risk at 1 and 6 months of~     treatment.~   "
141499|NCT01715181|"~     Older adults with Alzheimer's disease and other forms of dementia frequently develop~     challenging neuropsychiatric symptoms (NPS) as a result of their illness. Non-pharmacological~     strategies to manage these symptoms such as music, exercise, and participating in pleasant~     social events have been demonstrated to be safe and effective strategies to reduce these~     behavioral symptoms. Our project, Volunteers Adding Life in Dementia (VALID), will design and~     implement a volunteer-led program to reduce behavioral symptoms and improve the quality of~     life of older adults with dementia who are residing in long-term care facilities.~   "
141500|NCT01715168|"~     The purpose of this study is to find the answers to the following research question(s):~      1. Is the study drug equivalent to the approved drug, Doxil/Caelyx, and does it act the same~     way in the body as the approved drug?~      ATI-0918 is believed to be a generic of Doxil/Caelyx and this is what the study is trying to~     prove. All people who participate in this study will receive the research study medication~     (ATI-0918) and Doxil/Caelyx in addition to best supportive care (treatment for symptoms).~      The study drug being tested in this study works the same as the FDA (government) approved~     drug doxorubicin HCl. ATI-0918 is a generic (the same) formulation of doxorubicin HCl being~     delivered (given to the patient).~   "
141501|NCT01715155|"~     The purpose of this study is to evaluate the incidence rate of progression of disease, to~     describe the diagnostic and clinical management in patients with Metastatic Breast Cancer in~     the clinical practice in Bulgaria.~   "
141502|NCT01715142|"~     Pancreatic ductal adenocarcinoma (PDAC) is a highly lethal disease with conventional~     treatments having little impact on disease course. Novel approaches are urgently needed to~     address inherent resistance to the current therapies and to identify new drugs or~     combinations that will have a high chance of success in pancreatic cancer patients. This~     proof-of-concept trial is studying the dynamic tumor response after the administration of a~     short course of gemcitabine and nab-paclitaxel (Abraxane) (a) during a window interval (4~     weeks= 1 cycle) before surgery in resectable pancreatic cancer (cohort 1 = 21 patients) and~     (b) during at least 8 weeks (2 cycles) in locally advanced or metastatic pancreatic cancer~     (cohort 2 = 10 patients).~   "
141503|NCT01715129|"~     Assess the efficacy and safety of Triptorelin pamoate 3M formulation (11.25mg) when~     administered by subcutaneous route.~   "
141504|NCT01715116|"~     The purpose of this study is to determine whether Enhanced device programming to reduce~     therapies (i.e. anti tachycardia pacing (ATP) episodes and shocks (both appropriate and~     inappropriate)) is safe for patients implanted with an Implantable Cardioverter-Defibrillator~     (ICD). The secondary objective is to examine the impact of Enhanced programming on (i) ATPs~     and shocks (both appropriate and inappropriate) and (ii) quality of life and distress.~   "
141505|NCT01715103|"~     Current knowledge on mucosa, especially genitals in women, however, remain inadequate,~     especially regarding defense mechanisms and possibilities for a vaccine to induce an active~     immune response at mucosal front door of the most pathogens. Induction of mucosal immune~     response has emerged as a research priority research prophylactic vaccine.The development of~     strategies to prevent sexual transmission of HIV-1 depends in part on an understanding of~     specific and innate immune mechanisms involved in this transmission.~      MUCOVAC is a feasibility study of the immunological and transcriptomic analysis of~     cervicovaginal samples of women infected or not infected with HIV-1. We also assess tolerance~     samples taken by cytobrush and cervicovaginal washings, efficiency and reproducibility of the~     sample by cytobrush and cervicovaginal lavage for transcriptomic analysis, measurement of~     cytokines by Luminex technology, quantification of IgG and IgA. In blood we will determine~     the phenotype of B cells and Tfh cell frequency (T follicular helper) and quantification of~     serum immunoglobulins and will perform a transcriptomic analysis of blood cells. Finally we~     will make correlations with the observed responses at the genital mucosa.~      This pathophysiological exploratory study will be performed in 20 women infected with HIV-1~     and 20 healthy women recruited from two centers in France and will include a screening visit~     and two visits M0 and M1 during which mucous and blood samples will be performed.~      The results of the study will capitalize skills in biology mucosa, using powerful tools to~     assess mucosal immunological parameters.~   "
141506|NCT01715090|"~     The main objective of the study is to determine whether an intensive web-based titration~     system, called PANDIT (Patient Assisting Net-based Diabetes Insulin Titration), is effective~     in improving glycaemic control in patients with diabetes mellitus type 2 using a basal~     insulin, compared to standard care.~   "
141507|NCT01715077|"~     Participants will be taking 3 mg/kg ipilimumab intravenously over a 90-minute period every 3~     weeks for a total of four doses. Tumor-infiltrating lymphocytes (TILs)will be analyzed for~     functional characteristics.~   "
141532|NCT01714752|"~     Heart failure with preserved ejection fraction (HFPEF) is common and is a real public health~     issue. Diagnosis, especially when there are no congestive signs, is difficult. It has been~     shown that many patients with suspected HFPEF had left ventricular (LV) filling pressures~     elevated only at exercise (normal at rest).~      Using stress echocardiography and taking into account left atrial (LA) remodeling at rest as~     a memory of chronic elevation of filling pressures. We believe that it is possible to~     improve the noninvasive diagnosis of exercise elevation of the LV end-diastolic pressure~     (LVEDP).~   "
141508|NCT01715064|"~     In Canadian men, prostate cancer (PCa) is the most prevalent form of cancer and the third~     leading cause of cancer-related death. Unfortunately, PCa survivors are often burdened with~     feelings of anxiety and depression associated with the disease and associated treatments.~     Short-term exercise interventions (8-24 weeks) have improved psychosocial well-being in this~     population, but the impact of single bouts of exercise and related psychological or~     neurological changes have never been studied. The primary objective of the proposed study is~     to examine the effect of an acute bout of exercise on neurophysiological and psychological~     indicators of well-being in a randomized controlled trial (RCT) of 36 men with PCa.~     Participants will be randomly assigned to the intervention (60 min exercise) or control (60~     min of television) and will undergo a brief neurological test (cortical silent period) and~     psychological questionnaires before and after their group assignment.~   "
141509|NCT01715051|"~     The primary objective of this study is to collect pilot data on the efficacy of D-serine,~     relative to placebo, as a cocaine dependence treatment. Secondary objectives include~     evaluating D-serine, relative to placebo, on: 1. safety in treating cocaine-dependent adults~     and 2. tolerability.~   "
141510|NCT01715038|"~     The program effectiveness study aims to assess the effect of a lipid-based nutrition~     supplement (LNS) and micronutrient powder (MNP) provided in a programmatic context for~     improving maternal nutritional status during pregnancy and lactation (LNS only), and~     preventing malnutrition in infants and young children (LNS and MNP) in Bangladesh.~   "
141511|NCT01715025|"~     Women with measured menstrual bleeding >80ml per cycle and no contraindications to combined~     oral contraceptive use will be assigned to an oestradiol/nomegestrol acetate oral~     contraceptive for 3 cycles during which they will collect all menstrual blood and send all~     used sanitary protection to the laboratory at the University of Sydney for estimation of~     blood loss by the alkaline haematin method.~      Hypothesis:~      An estradiol/nomogestrel acetate (E2/NOMAC) combined pill will be effective in controlling~     HMB in the majority of women without structural pelvic pathology.~      Main outcome:~      The primary efficacy end-point will be the proportion of women with a reduction of menstrual~     blood loss ≥ 50% from baseline.~   "
141512|NCT01715012|"~     This study is a randomized, double blind, placebo controlled trial at a single site. The~     primary objective is to evaluate the safety of ACCS in diabetic subjects with deep burns. The~     secondary objectives of this study are to (1) evaluate efficacy of ACCS in healing burns and~     (2) evaluate whether treatment with ACCS results in less scarring, in subjects with diabetes~     separately comparing healing of the skin graft and the skin graft donor site using ACCS plus~     a burn dressing versus placebo and a burn dressing.~   "
141513|NCT01714999|"~     Following a recent publication by the authors [1], there is no standardized treatment regime~     for the treatment of lacerations of the olecranon or prepatellar bursa, although primary~     bursectomy seems to be the most common treatment regime in Germany, Austria and Switzerland.~     The aim of this study is to prospectively follow patients who suffered from an acute~     traumatic laceration of the OB or PB treated, according to the local standards, either by~     bursectomy (Vie, AT) or bursal reconstruction and direct wound closure (Muc, GER).~      [1] Baumbach et al. Evaluation of the current treatment concepts in Germany, Austria and~     Switzerland for acute traumatic lesions to the prepatellar and olecranon bursa. Injury (2012)~   "
141514|NCT01714986|"~     The investigators want to try the psycho educational method The Affect School with Script~     Analysis and the physiotherapeutic mind-body therapy Basal Body Awareness Therapy in~     patients with diabetes, high HbA1c and psychological symptoms, in order to improve~     psychological health- with the primary outcome reduced depression. Secondary outcomes are~     improved improved glycemic control and self-image, and reduced alexithymia and anxiety.~   "
141515|NCT01714973|"~     The objective of this study is to evaluate the safety and efficacy of ACCS in treating~     radiation burns of the skin in patients undergoing treatments for breast cancer and to~     compare ACCS treated burns with those treated with saline placebo controls.~   "
141516|NCT01714960|"~     -  To assess the safety and tolerability of repeat dose topical administration of MRZ-99030~          Ophthalmic Solution with ascending doses in healthy subjects (stage 1) and glaucoma~          subjects (stage 2).~        -  To assess plasma pharmacokinetics and urine concentration of MRZ- 99030 and its~          metabolite MRZ-9499 after single and repeat dose topical administration of MRZ-99030~          Ophthalmic Solution.~   "
141517|NCT01714947|"~     This is a 2-part, open-label study in 4 to 6 evaluable patients with advanced solid tumors or~     lymphomas. This study is intended to provide a quantitative characterization of the mass~     balance, routes of metabolism, and excretion pathways of alisertib.~   "
141518|NCT01714934|"~     The pathogenesis of idiopathic pulmonary fibrosis (IPF) is debatable. Looking for an insult~     to lung parenchyma that generates the pathogenesis of the disease is challenging. Pepsin is a~     proteolytic enzyme present in the gastric juice. Microaspirations of gastric content were~     described as a potential factor for injury in many chronic lung disorders. Bronchoalveolar~     lavage (BAL) is a routine investigation technique in interstitial lung diseases. The presence~     of pepsin in the BAL fluid recovered from patients with IPF may indicate a possible role for~     gastric microaspirations in the pathogenesis of the disease.~   "
141519|NCT01714921|"~     Examination of application and efficacy of Smart Shock algorithm in ICD patients~   "
141520|NCT01714908|"~     Erlotinib with concurrent radiotherapy has superior efficacy and comparable safety profile in~     unresectable stage III non-small cell lung cancer (NSCLC) patients with activating mutation~     of epidermal growth factor receptor (EGFR) in exon 19 or 21 versus etoposide plus cis-platin~     with concurrent radiotherapy.~   "
141533|NCT01714739|"~     To assess the safety and tolerability and preliminary anti-tumor activity of lirilumab~     (BMS-986015) given in combination with nivolumab (BMS-936558) and to identify dose limiting~     toxicities (DLTs) and the maximally tolerated dose (MTD) of the combination. In addition, to~     assess the combinations of lirilumab and nivolumab or lirilumab and nivolumab plus ipilimumab~     (BMS-734016) in subjects with advanced (metastatic and/or unresectable) refractory solid~     tumors.~   "
141534|NCT01714726|"~     The study is designed to evaluate the clinical efficacy and safety of MEDI2070 as compared to~     placebo. Investigational product will be administered as intravenous infusion in double-blind~     period, and as a subcutaneous injection in open-label period~   "
141521|NCT01714895|"~     Achieving near-normoglycaemia has been established as the main objective for most patients~     with diabetes. However, it is well known that intensification of treatment is associated with~     an increase in the frequency of hypoglycemia, especially in the context of insulin therapy.~     The burden of hypoglycemia in terms of psychological implications, morbidity and even~     mortality, explains why it has been defined as the main limiting factor to achievement of~     good metabolic control.~      Continuous subcutaneous glucose monitoring (CGM) devices have been claimed to be useful in~     hypoglycemia detection/prevention, allowing theoretically for safer intensification of~     therapy in diabetic patients. However, accuracy of CGM devices, especially in the~     hypoglycemic range, raises some concerns. In fact, commercially available CGM devices~     estimate plasma glucose from measurements in the interstitial fluid and not in plasma.~     However, the relationship between plasma and interstitial glucose is not fully understood,~     especially under dynamic conditions, and this may explain the poor CGM performance during~     rapid changes in blood glucose and hypoglycemia.~      In this project, the relationship between plasma and interstitial glucose will be evaluated~     under conditions of normal glucose concentrations and hypoglycemia. Experiments will be~     performed to assess the role, if any, of different plasma insulin concentrations on the~     accuracy of CGM.~      All the information obtained may be relevant to the improvement of the ability of CGM devices~     to detect hypoglycemia and hypoglycemic risk.~   "
141522|NCT01714882|"~     The investigators are trying to determine stress management strategies in couples undergoing~     In Vitro Fertilization (IVF).~   "
141523|NCT01714869|"~     The purpose of this study is to find out how effective and feasible an 8-week course of~     Swedish massage is, for reducing pain and increasing function in adults who are VA healthcare~     users, with osteoarthritis (OA) of the knee.~   "
141524|NCT01714856|"~     Study subjects were screened and enrolled for the study. Subjects were housed in the clinical~     facility from not less than 12 hours pre-dose till at least 30 hours post-dose in each~     period. After maintaining at least 10 hours of overnight fast Test or Reference product was~     administered orally (as per the randomization schedule) to each subject with about 240 mL of~     water at ambient temperature in each period by trained study personnel after consuming the~     whole standardized high fat non-veg breakfast.~      The pre-dose (0.00 hours) blood sample was collected before dosing and post-dose samples were~     collected at 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 7.50, 8.00, 8.50, 9.00, 9.50, 10.00, 10.50,~     11.00, 11.50, 12.00, 12.50, 13.00, 14.00, 16.00, 20.00, 24.00 and 30.00 hours in each study~     period with a washout period of 7 days between the dosing of two periods. Subjects were~     continuously monitored for well being i.e., blood pressure, radial pulse and oral temperature~     before check-in, prior to drug administration and at regular intervals post dose in each~     period. The concentration of Ropinirole in plasma samples obtained from study subjects was~     determined using validated LC-MS/MS method. Pharmacokinetic and statistical analyses were~     performed on obtained drug concentration data, using appropriate software.~   "
141525|NCT01714843|"~     This study is to investigate the efficacy, safety, and plasma concentration change of ASP0456~     in patients with constipation-predominant irritable bowel syndrome.~   "
141526|NCT01714830|"~     Chronic pelvic pain (CPP) can affect both sexes and lasts at least for 3 months. CPP in women~     could be due to endometrioses, ovarian cyst, colitis, etc, making the correct diagnosis~     important (1-3). The most prevalent reason for CPP in men is non-bacterial chronic~     prostatitis and in many cases they are considered equivalent to each other (4).~      Chronic non-bacterial prostatitis is associated with pain in pelvic region and could be~     associated with other symptoms such as dysuria, myalgia, arthralgia, chronic fatigue, burning~     sensation in the urethra, abdominal, urine frequency, and pain after ejaculation (4-6).~     Chronic prostatitis / chronic pelvic pain syndrome (CP/CPPS) is devided into two groups: III~     A Type (inflammatory) and III B (Non-inflammatory). The difference between the two groups is~     the presence of leukocytes in prostatic secretions after prostate massage, urine and semen~     (7,8).~      In general population, the prevalence of chronic pelvic pain syndrome is about 0.5 percent~     because many patients do not consider their symptoms as disease, while 6.3% of people may~     show symptoms (9-11).~      One of the most important challenges in the treatment of chronic prostatitis / chronic pelvic~     pain syndrome, is that its etiology is obscure and it is known as a multi-factorial syndrome.~     The proposed explanations are infection, psychological reasons, autoimmunity and~     neuro-myospasm. Hypotheses about endothelial cells defect and cardio vascular disease have~     also been proposed, upon which the new therapies have been based.~      In duplex mapping study of prostatic vessels in two groups of healthy and chronic~     non-bacterial prostatitis people, it was shown that there was a significant reduction in~     systolic flow in prostatic arteries in people who had chronic non-bacterial prostatitis, and~     there was a direct association between pain and blood flow intensity, suggesting chronic~     ischemia as a possible cause for pain (13). Pain in prostate without significant infection is~     the hallmark of chronic prostatitis / chronic pelvic pain syndrome (5). In physical exam,~     prostate or pelvic tenderness may be observed in half of the patients.~      The diagnosis of chronic prostatitis / chronic pelvic pain syndrome is challenging. No~     specific lab test exists for its detection. Prostate specific antigen (PSA) level, which is~     typically increased in acute infection, is usually normal in this condition. The diagnostic~     approach in these patients is based on ruling out other curable causes such as benign~     prostatic hyperplasia or bladder cancer (14-20).~      NIH Chronic Prostatitis Symptom Index (NIH-CPSI) is used to evaluate symptom severity and~     response to treatment in these patients. A reduction of 4-6 points in the score is considered~     significant response to the treatment (21).~      There is no first line treatment for patients of chronic pelvic pain syndrome. The use of~     anti-bacterial, alpha-blockers or anti-inflammatory drug is logical. However, if the patient~     does not respond, further administration is not helpful. In non-responders, combination of~     drugs or other non-medical methods should be considered (23-26).~      As discussed earlier, blood flow reduction, ischemia and disorders in endothelium of vessels~     may cause pain in these patients and methods to improve blow flow may help(13,27). One of~     these methods is extracorporeal shockwave therapy (ESWT) which is typically used for~     tendonitis, acceleration in bone reunion and wound healing, improvement in muscle movements~     through a reduction in passive muscular tonus, increasing muscular range of motion after~     cerebrovascular accident (CVA), treatment of Peyronie's disease and erectile dysfunction~     (28-30).~      Shoskes et al compared 24 chronic prostatitis patients with 11 controls in terms of vascular~     stiffness, indexes of increased blood flow, vasodilation and reactive vascular hyperemia,~     using Endo-PAT ® 2000-Machine. They showed that endothelial disorder and stiffness along with~     the risk of cardiovascular disorders are increased in CP/CPPS (31).~      The use of ESWT for the treatment of CP/CPPS has been evaluated in a few studies. In a~     double-blind randomized control trial, Zimmermann et al placed 60 patients with chronic~     pelvic pain syndrome from chronic non-bacterial prostatitis into two groups and treated one~     of them in 4 sessions with a frequency of 3000 per session. The treatment group showed~     superior results in terms of symptom improvement(32).~      In another study, Zimmermann et al followed 34 patients with chronic pelvic pain syndrome,~     after one, four and twelve weeks post ESWT in terms of quality of life and pain reduction.~     They showed that this method is useful and without any complications (33).~      Considering the promising results of the cited articles along with the paucity of data in~     this regard we decided to perform a double-blind sham-controlled study to evaluate the~     effectiveness of ESWT in CP/CPPS.~   "
141527|NCT01714817|"~     The purpose of this study is to evaluate (Abatacept) for treatment of lupus nephritis when~     used on a background of Cellcept (mycophenolate) and prednisone (corticosteroids)~   "
141528|NCT01714804|"~     The objective of this study is to prospectively evaluate the performance of Integra Accell~     Evo3 Demineralized Bone Matrix as an adjunct for instrumented lumbar spine fusion with a~     retrospective comparison to a historical patient cohort.~   "
141529|NCT01714791|"~     The purpose of this study is to determine the short and long term effects of osteopathic~     treatment on pulmonary function, pain and quality of life in patients after coronary artery~     bypass graft (CABG) surgery. The study is a randomized controlled trial.~   "
141530|NCT01714778|"~     Electronic cigarettes or e-cigarettes (EC) may have a potential public health benefit as a~     safer alternative to smoking and possibly also as an aid in tobacco dependence treatment.~     However, there are concerns about their safety and whether they can deliver nicotine~     consistently and in doses necessary for such effects.~      To be able to consider the safety of ECs and their potential in harm reduction, data are~     needed comparing the exposure to the potential toxicant, acrolein, in smokers of conventional~     cigarettes, users of EC, and people who use both products at the same time.~      To accurately assess EC nicotine delivery, data are needed from people who use them~     regularly, as there is some evidence of higher and faster nicotine absorption in experienced~     users compared with naïve users who try them once in an artificial laboratory setting.~      This study will provide information on both of these issues. Forty smokers will be given EC~     to use, in addition to behavioural support, as part of a stop smoking attempt. Levels of~     acrolein and nicotine will be measured before and after 4 weeks of EC use.~   "
141531|NCT01714765|"~     When kidney cancer spreads beyond the kidney, it is known as metastatic kidney cancer. This~     is very difficult to treat and almost all patients will die of their disease within 3 years.~      Sunitinib has become standard therapy for untreated patients with metastatic clear cell renal~     (kidney) cancer. It targets a growth factor known as VEGF which is important in treating~     renal cancer. Although the results with this drug are impressive, patients develop resistance~     to the drug, relapse and die of renal cancer. It is currently standard practice is to treat~     patients with everolimus when resistance to sunitinib occurs; this is associated with clear~     clinical benefit. However the median time to progression with everolimus is 4.9 months in~     previously treated patients, therefore further improvement in treating patients is required.~     The optimal way of achieving this is to increase the efficacy of everolimus by adding agents~     which directly target the cause of resistance to sunitinib.~      Dovitinib is a promising new drug in renal cancer. Dovitinib blocks cellular functions such~     as activation of downstream signalling molecules, cell proliferation and survival. Combining~     dovitinib and everolimus is very attractive.~      This trial is aimed to establish the maximum tolerated dose for the combination of dovitinib~     and everolimus in clear call renal cancer, which can then be taken into a randomised phase II~     study.~      A maximum of 30 patients will be recruited into this multi centre national trial.~      Expansion Cohort:~      The study has established the MAD and the MTD. The MTD was Cohort 0 (Everolimus 5mg and~     Dovitinib 200mg). 6 patients were recruited in this cohort with only 1 patient experiencing a~     DLT. A further 3 patients were recruited into Cohort 1 (Everolimus 5mg and Dovitinib 300mg),~     where 2 patients experienced a DLT.~      A total of 7 assessable patients will be recruited during the expansion phase at the MTD~     (Cohort 0: Everolimus 5mg and Dovitinib 200mg) to further define the safety, tolerability,~     efficacy, PK and biological end points.~      Assessable patients for the expansion cohort are defined as being on the study for a minimum~     of 6 weeks. Any patients enrolled who are not assessable will be replaced.~   "
141535|NCT01714713|"~     This study is being conducted to further investigate the safety of prolonged exposure to~     EVP-6124 in subjects with Schizophrenia receiving a stable dose of an atypical antipsychotic~     who completed double-blind treatment on studies EVP-6124-015 and EVP-6124-016.~   "
141536|NCT01714700|"~     Background: The interactive effects of resistance training and dietary protein on hormonal~     responses in overweight or obese adults are not clear and remain controversial. Investigators~     tested the effect of an isocaloric high-protein diet on body composition, ghrelin, and~     metabolic and hormonal parameters during a 12-week resistance training program in untrained~     overweight healthy young men.~      Methodology: Investigators randomized 18 healthy young males to a standard diet (ST group) or~     an isocaloric high protein diet (HP group). Subjects in both groups participated in a 12~     week-resistance exercise program. Investigators measured body composition, lipid profile,~     homeostatic model assessment of insulin resistance (HOMA-IR) indices, total ghrelin, and~     exercise related hormones at baseline and 12 weeks.~   "
141537|NCT01714687|"~     This post-market study aims to compare health outcomes for Recurrent Acute Rhinosinusitis~     (RARS) patients treated with balloon sinus dilation (BSD) versus medical management alone.~   "
141538|NCT01714674|"~     Blood cardiac troponin T (cTnT) concentration is a widely used marker of acute cardiac~     injury. Previous research has shown that type 2 diabetic patients may experience large~     increments in cTnT levels over the subsequent hours following a single bout of~     moderate-intensity endurance-type exercise. This phenomenon is likely attributed to cardiac~     ischemia-reperfusion injury caused by reduced nitric oxide (NO) bioavailability. Recent~     evidence indicates that ingestion of dietary nitrates dramatically increases the~     bioavailability of NO, and as such, may be protective against cardiac ischemia-reperfusion~     injury.~      The investigators hypothesize that dietary nitrate supplementation blunts the rise in cTnT~     levels following exercise in type 2 diabetic patients.~   "
141539|NCT01714661|"~     The purpose of this study is to determine if EVP-6124 (an alpha-7 nAChR agonist) enhances the~     cognitive abilities of subjects with Schizophrenia who are also taking stable antipsychotic~     therapy.~   "
141540|NCT01714648|"~     Ovarian hyperstimulation syndrome (OHSS) is a major complication of ovarian stimulation for~     IVF if hCG is used to trigger final oocyte maturation. The investigators propose that using~     GnRH agonist as a trigger will eliminate OHSS, even in high-risk patients.~   "
141541|NCT01714635|"~     The purpose of this clinical trial is to evaluate the safety and effectiveness of the TECNIS~     Multifocal 1-Piece Intraocular Lens (IOLs), Models ZKB00 and ZLB00 which will each provide~     statistically better distance-corrected near visual acuity compared to the monofocal control~     lens. Complication and adverse event rates associated with each Multifocal IOL will be within~     the ISO SPE rate for posterior chamber IOLs.~   "
141542|NCT01714622|"~     Gastric cancer is still one of the most common malignance in Korea. Because of the popularity~     of regular check ups, early detection of gastric cancer has increased, consequently, the~     survival of the patients also has increased. In this reason, the interest of outcomes after~     gastrectomy for gastric cancer move survival only to quality of life of these patients.~      Although the definition of metabolic syndrome is various, but it is normally accepted as a~     state that insulin resistance or glucose intolerance combined with hypertension or~     hyperlipidemia or obesity. Metabolic syndrome is a worldwide health problem, and the~     treatment is modification of life style, weight loss and medication. However, in most of the~     patients metabolic syndrome is considered not curable disease. Recent studies have shown that~     some bariatric surgery offers not only control the overweight but also metabolic syndrome.~     The exact mechanism is still unknown but decreased gastric volume and intestinal bypass~     itself seemed to play an important role to improve metabolic syndrome over just decreased~     weight.~      For treating gastric cancer, gastrectomy is essential and the extent of gastrectomy is varied~     subtotal and total gastrectomy according to the location of tumor. Also, reconstruction type~     is varied gastroduodenostomy and Roux-en-Y gastrojejunostomy after subtotal gastrectomy,~     esophagojejunostomy after total gastrectomy. This kind of operation for gastric cancer lead~     decreased gastric volume and/or intestinal bypass, which means this operation could lead~     similar effect of bariatric surgery. Already, there have been several retrospective reports~     that metabolic syndrome or diabetes was improved after gastrectomy for gastric cancer but no~     prospective study about this subject yet in Korea.~      The purpose of this study is that evaluating the degree of improvement of metabolic syndrome~     after gastrectomy for gastric cancer, and analyze the differences between the type of~     operation.~   "
141543|NCT01714609|"~     Sorafenib is approved by the US FDA for the treatment of unresectable (can not operate) liver~     cancer and for renal cell carcinoma. Sorafenib is a drug that inhibits the growth of cancer~     cells and prevents the formation of new blood vessels that would otherwise help the cancer~     spread.~      Studies in experimental animals have shown that sorafenib may also lower portal vein pressure~     (the pressure of the blood passing from the intestine through the liver.) This study seeks to~     determine if sorafenib lowers the blood pressure in liver blood vessels (portal vein~     pressure) in patients with cirrhosis who have high portal vein pressure. The study will also~     obtain information whether sorafenib is safe in this patient population.~      Half of the patients will be given sorafenib and half will be given a placebo (a pill without~     any medicine in it.) This allows a comparison of the reactions of people who take sorafenib~     to those who do not.~   "
141544|NCT01714596|"~     The goal of this study is to evaluate the effect of treatment of post-op wound infection in~     long bones after fracture fixation or joint fusion and either: (Group 1) operative~     debridement and PO antibiotic treatment for 6 weeks; or (Group 2) operative debridement and~     IV antibiotics for 6 weeks.~      Primary Hypothesis: The rate of treatment failure by one year in Group 1 will be non-inferior~     to the rate in Group 2. Treatment failure is defined as wound problems that require surgery~     >2 weeks after initial debridement, infection recurrence, infection with a new pathogen,~     joint erosion, implant failure, medical problems related to the treatment administration~     which necessitates a switch from one arm to the other.~   "
141545|NCT01714583|"~     The objective of this study is to evaluate the association between positive end-expiratory~     pressure (PEEP) setting and cardiac function, as measured by cardiac index, in patients with~     acute respiratory distress syndrome (ARDS) who were managed on the NHLBI ARDS Network Fluid~     and Catheter Treatment Trial (FACTT) fluid protocols.~   "
141546|NCT01714570|"~     Neutropenia is very common in patients received hematopoietic stem cell transplantation, with~     median duration of about 14 days. In 2010 update, IDSA recommended Piperacillin/tazobactam as~     first-line mono-therapy for febrile patients with neutropenia of high risk. In china, the~     data of piperacillin/tazobactam for febrile neutropenia after hematopoietic stem cell~     transplantation is very limited.~      The current study will evaluate the efficacy of piperacillin/tazobactam compared with~     imipenem/cilastatin for febrile neutropenia after transplantation.~   "
141593|NCT01713946|"~     This study will evaluate the efficacy and safety of two trough-ranges of everolimus given as~     adjunctive therapy in patients with tuberous sclerosis complex (TSC) who have refractory~     partial-onset seizures.~      The study consists of 4 phases for each patient [Baseline phase: From Screening Week -8 (V1)~     to randomization visit at Week 0 (V2)], Core phase, from randomization at Week 0 (V2) to Week~     18 (V11)], Extension phase from Week 18 (V11) until 48 weeks after the last patient has~     completed the core phase, and Post Extension Phase.~   "
141547|NCT01714557|"~     Neutropenia is very common in patients received hematopoietic stem cell transplantation, with~     median duration of about 14 days. Almost all neutropenia will suffer from febrile without~     prophylactic antibiotics. IDSA recommended fluoroquinolones as prophylaxis in neutropenia~     patients of high risks, while in China, major pathogens possess high resistance to~     fluoroquinolones. It is not clear whether prophylaxis is of benefit, nor the appropriate~     prophylaxis regimen.~      The current study will evaluate the three different regimen:~        1. No prophylaxic antibiotic~        2. Piperacillin as prophylaxis for neutropenia patients. Piperacillin has anti-pseudomonas~          activity.~        3. Piperacillin/tazobactam as prophylaxis for neutropenia patients. Piperacillin/tazobactam~          has highest susceptibility rate among common anti-pseudomonas antibiotics.~   "
141548|NCT01714544|"~     The purpose of this study is to determine whether Cloderm Cream is effective for topical~     treatment of moderate psoriasis over 28 days.~   "
141549|NCT01714531|"~     The majority of trauma survivors experience prolonged and profound physical and psychosocial~     disability, with up to 50% unable to return to productive employment. The Centers for Disease~     Control (CDC) estimates that more than 1 million of these individuals experience a mild~     traumatic brain injury (TBI) and cost the United States nearly $17 billion each year.~     Symptoms related to mild TBI result in cognitive, functional, and emotional impairments that~     can lead to vocational and social disability. Long-term cognitive deficits include problems~     with memory and attention, and most importantly executive functioning. Depressive and~     post-traumatic stress disorder (PTSD) symptoms are extremely common in individuals with~     cognitive impairment, occurring in up to 50% and 33% of individuals, respectively. The~     investigators have found that 55% of trauma patients with mild TBI have profound cognitive~     impairments in executive functioning at one-year survival. Executive functioning is defined~     as a cognitive domain that controls the execution of complex activities of daily living~     essential for purposeful, goal directed behaviors. Deficits in executive functioning are the~     most disabling of all cognitive impairments and affect a person's ability to manage~     effectively in one's personal and professional life. Current literature shows that deficits~     in executive functioning contribute to reduced quality of life, difficulty in returning to~     work, and persistent psychological distress in various medical and surgical populations.~     Cognitive rehabilitation has proven effective for decreasing persistent cognitive impairment~     and functional disability in patients with TBI. The overall goal of cognitive rehabilitation~     is not only to improve a person's ability to process and interpret information but to~     increase self-confidence and self-efficacy for coping with emotional distress. Despite~     evidence supporting the use of cognitive rehabilitation, few studies have systematically~     addressed cognitive treatment for individuals with mild TBI. Therefore, the investigators~     propose to conduct a three-group randomized controlled trial to determine the efficacy of~     Goal Management Training (GMT), a structured manual-based intervention targeting executive~     functions that impact a person's ability to carry out daily tasks. The investigators~     hypothesize that telephone-based GMT will improve cognitive functioning, functional status,~     and psychological health in trauma survivors with mild TBI. Emerging research suggests that~     telephone rehabilitation is a feasible and effective alternative (with much broader~     applicability) to clinic-based interventions. Trauma survivors with mild TBI have limited~     access to rehabilitation services due to financial constraints and mobility and geographic~     restrictions that render clinic-based rehabilitation impractical. This clinical trial will~     recruit 90 trauma survivors with mild TBI and cognitive deficits in executive functioning.~     Eligible participants will be randomized to either 10-week (1) telephone-based GMT; (2)~     telephone-based attention-control; or (3) usual care. Primary outcomes will include observed~     and self-reported executive functioning and self-reported functional status as measured by a~     battery of standardized and previously validated cognitive tests and instruments, including~     the Delis-Kaplan Executive Function System Tower Test, the Dysexecutive Questionnaire, and~     the Functional Activities Questionnaire. Secondary outcomes will consist of depressive and~     PTSD symptoms, as measured by the Patient Health Questionnaire-9 and PTSD Checklist -~     Civilian Version, respectively. Outcome data will be collected at baseline (6 weeks after~     hospitalization) and at 4 month (treatment completion) and 7 month follow-up from hospital~     discharge. Our cognitive rehabilitation intervention will serve to broadly disseminate~     evidenced-based cognitive strategies to a trauma population that has difficulty returning to~     productive life both inside and outside the home due to profound functional and psychological~     disability. Findings from this study will support future research to improve the cognitive,~     functional and psychological health of patients following major trauma through innovative~     rehabilitation interventions and delivery methods.~   "
141550|NCT01714518|"~     The purpose of this study is to assess efficiency and safety of cryobiopsy compared to~     video-assisted thoracoscopic lung biopsy (VATS) in diagnosis of interstitial lung diseases~     (ILD). To that end, this non-interventional study prospectively collects data from patients~     undergoing routine diagnosis of ILD. In some of those patients less invasive diagnostic~     approaches do not yield a definitive diagnosis. Thus, they will ultimately be subjected to~     VATS if this procedure is reasonable. The information gained by this study will help to~     assess the significance of cryobiopsy in contrast to VATS in this particular disease group.~   "
141551|NCT01714505|"~     An unblinded, randomized, cross-over design with each patient participating in two 40-hour~     outpatient admissions: (a) Experimental involving automated Control-to-Range (CTR) and (b)~     Control using Continuous Glucose Monitor (CGM)- augmented insulin pump treatment outside of a~     hospital based clinical research center. The principal goal is to validate a smart~     phone-based control-to-range (CTR) system for ambulatory use and to estimate the effect of~     CTR vs. sensor-augmented pump therapy, thereby providing justification for further larger~     home-based trials of CTR.~   "
141552|NCT01714492|"~     Utilize previously developed mathematical model to determine in vivo knee mechanics~     (kinematics, forces, stresses, areas and sound) for subjects having a Sigma Posterior~     Stabilizing (PS) mobile bearing (MB) total knee arthroplasty (TKA). There are several~     hypotheses for this study, although the most prominent is: Subjects having a Sigma RP PS TKA~     will experience polyethylene bearing rotation at 10 years post-operative, similar to their~     previous evaluations at six months, two years and five years.~   "
141553|NCT01714479|"~     Warfighters often experience physical overload, as the uniform and associated gear that they~     carry burdens them with substantial loads. The loads increase energy expenditure to levels~     that exceed a Warfighter's typical energy intake. The typical assault load is approximately~     25 kg, although loads as high as 55 kg are often carried, which when combined with extreme~     energy expenditures can degrade health and performance, and increase the risk of injury.~     Branched-chain amino acid (leucine) supplementation may confer protection against the~     negative effects of operational stress by stimulating muscle protein synthesis and reducing~     degradation. This study will determine if leucine-enriched nutrition supplementation confers~     protection against the negative consequences of sustained load carriage exercise, and explore~     the mechanisms by which leucine might impart protection.~   "
141554|NCT01714466|"~     A study to assess the pharmacodynamics, safety and tolerability of a PEG-based bowel~     cleansing solution (MOVIPREP®)~   "
141555|NCT01714440|"~     The major aim of this research study is to investigate the relationship between genetic~     variation in DNA (inherited code material in the cells of the body) and factors affecting~     transplant outcomes, like the drugs people receive or the way their immune systems work, for~     example. To do this, investigators will collect blood samples from participants. Genetic~     material will be separated from each blood sample and analyzed, looking for genetic~     variation.~   "
141556|NCT01714427|"~     The purpose of this study is to investigate the local and systemic inflammatory response and~     haemostatic alterations in the lungs after lipopolysaccharide (LPS) instillation and to~     determine the feasibility of imaging techniques to quantify lung inflammation in an adapted~     human endotoxin instillation model.~      The investigators will also explore whether glucocorticoid treatment can blunt LPS effects.~   "
141557|NCT01714414|"~     A prospective, multicenter, open, randomized Phase 2a trial to confirm a sustained~     virological suppression defined as HIV-RNA <50 copies/ml of 3 different doses of Fozivudine~     in context to a standard Zidovudine based antiretroviral therapy regimen after 24 weeks of~     treatment in ART naïve, non subtype B HIV-1 infected individuals from Tanzania and Ivory~     Coast.~   "
141558|NCT01714401|"~     Patients of the ICU's often require bronchodialtatory treatment due to bronchospazm caused by~     conditions like : ARDS, COPD or asthma. The β2 adreneregic drugs are one of the most commonly~     used for this purpose. However it is known that they may cause tachycardia and may have~     substantial proarrhythmic effect. The investigators' aim is to estimate the influence of~     nebulized bronchodilatatory drugs on selected electrophysiological parameters, whose changes~     are generally recognized as potentially increasing the risk of ventricular and~     supraventricular arrhythmias. Two drugs will be compared - salbutamol given in two doses and~     ipratropium bromide~   "
141568|NCT01714271|"~     This family environment-focused health behavior change intervention is being carried out by~     extensively trained community health workers (promotores) familiar with the community in East~     Los Angeles. The hypothesis being tested is that home environment-focused health behavior~     change will reduce risk of arterial stiffness, an early-in-life predictor of heart disease.~     The community health workers will provide most of the health promotion counseling. The~     promotores will provide up to 16 counseling sessions to a designated adult family member~     without diabetes. The sessions will focus on improving the home environment in order to~     reduce television viewing, increase fruit and vegetable intake, decrease intake of refined~     carbohydrates, prompt more frequent monitoring of body weight and increase daily physical~     activity. The lifestyle change goals will be tailored to the families' capacity for change~     and will be consistent with the Dietary Guidelines for Americans, especially the MyPlate.gov~     messages, the Dietary Approaches to Stop Hypertension (DASH) diet and at least 30 minutes of~     daily moderate physical activity.~   "
141559|NCT01714388|"~     Remifentanil (RMFNT) is a very short active opioid, used for analgesia during general~     anaesthesia and for analgesic and sedative effect in intensive care units (ICU) patients.~     Registration for anesthesia includes bolus dose and continuous infusion, in ICU only infusion~     regimen is allowed. Pharmacokinetic/pharmacodynamic parameters of RMFNT results in rapid~     onset and offset of clinical effect, which makes this drug almost ideal in many situations.~     Unfortunately, its vagomimetic influence on cardiac activity may result in decrease of heart~     rate. It may be hypothesized that patients with parasympathetic predominance may be prone to~     more intense parasympathomimetic effect of this opioid. An optimal method for assessment of~     autonomic nervous system activity and assessment of influence of RMFNT on that activity is~     Heart Rate Variability (HRV) analysis. Parasympathetic predominance is expressed as high~     frequency (HF) power and HF/(LF+HF) (LF-low frequency) ratio in frequency domain and Root~     Mean Square of the Successive Difference (RMSSD), the number of pairs of successive NNs that~     differ by more than 50 ms (NN50), the proportion of NN50 divided by total number of NNs~     (pNN50) in time domain. The aim of this study is to verify the hypothesis that patients with~     predominance of parasympathetic activity are more subject to vagomimetic effect of RMFNT. HRV~     based on 5 minutes electrocardiogram (ECG) recorded before and after bolus dose of RMFNT will~     be analyzed. The occurrence of heart rate decrease will be than compared between patients~     with sympathetic and parasympathetic predominance measured prior to drug injection.~   "
141560|NCT01714375|"~     The goal of this study is to determine whether daily assessment and feedback of workers'~     noise exposures leads to more effective use of hearing protection and prevention of~     noise-induced hearing loss.~   "
141561|NCT01714362|"~     Pulling the eyeball during ophthalmic surgery provokes decrease in heart rate. This~     phenomenon is called oculocardiac reflex. In some patients asystole may occur. Other cardiac~     features of this reflex include hypotension, dysrhythmias, atrioventricular block. These~     cardiovascular disturbances may lead to decreased perfusion and ischemia of vital organs.~     Patients with existing cardiovascular disease are in risk of complications. Cardiovascular~     system is mainly innervated with autonomic nervous system (ANS). Sympathetic/parasympathetic~     activity may be determined by Heart Rate Variability (HRV). HRV analysis based on short 5~     minutes electrocardiography has been found useful for prediction of hypotension and~     bradycardia during induction of general anaesthesia and during spinal block. The aim of this~     study is to verify whether it is possible to predict oculocardiac reflex with the use of HRV~     analysis for ANS activity assessment, measured prior to the ophthalmic surgery.~   "
141562|NCT01714349|"~     Nerve Transfer surgery can provide improved hand function following cervical spinal cord~     injuries~   "
141563|NCT01714336|"~     Does tranexamic acid improve the perioperative care of those patients treated surgically for~     hip fracture by decreasing the proportion of patients requiring transfusion and decreasing~     total perioperative bleeding.~   "
141564|NCT01714323|"~     Cigarette smoking is the leading preventable cause of death in the U.S. The 2008 US Public~     Health Service Smoking Cessation Guideline recommends offering effective treatment to smokers~     in all health care settings, including hospitals. Nearly 4 million smokers are hospitalized~     each year, and hospital admission offers a teachable moment for intervention.~     Hospital-initiated smoking cessation intervention is effective, but only if contact continues~     for more than 1 month after discharge. The challenge is to translate this research into~     clinical practice by identifying an evidence-based cost-effective model that U.S. hospitals~     can adopt. The major barrier is sustaining contact after discharge. This project tests an~     innovative strategy to streamline the delivery and maximize the uptake of post-discharge~     smoking interventions.~      Specific Aim: To test the effectiveness of an innovative strategy to maximize smokers' use of~     evidence-based tobacco treatment (counseling and medication) after hospital discharge,~     thereby increasing the proportion of smokers who achieve long-term (6-month) tobacco~     abstinence.~      Study Design: A multi-site randomized controlled comparative effectiveness trial will enroll~     1350 adult smokers admitted to 3 acute care hospitals in Massachusetts and Pennsylvania. All~     subjects will receive a brief in-hospital smoking intervention and be randomly assigned at~     discharge to either Standard Care (passive referral to their state quitline) or Extended~     Care, a 3-month program consisting of (1) Free Medication: A 30-day supply of FDA-approved~     medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and~     refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive~     Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider. IVR~     aims to encourage medication adherence and enhance counseling efficiency by identifying~     smokers who need post-discharge support. Immediate transfer of a patient from automated IVR~     call to live telephone counselor will facilitate a successful connection to counseling.~      Outcomes, assessed at 1, 3, and 6 months after hospital discharge, are: (1) intervention~     effectiveness (cotinine-validated 7-day point-prevalence tobacco abstinence rate at 6 month~     follow-up [primary outcome] and other tobacco abstinence measures); (2) treatment~     utilization, and (3) cost-effectiveness (cost per quit). Exploratory analyses will examine~     the intervention's effect on hospital readmissions and mortality in the 6 months after~     discharge.~   "
141565|NCT01714310|"~     This project will characterize children and adolescents with severe mood dysregulation (SMD)~     and conduct a pilot study of combination pharmacotherapy as a basis for future intervention~     trials.~      Eligible participants assessed for SMD will have 4 weeks open titration with lisdexamfetamine~     (LDX) to optimal dose, followed by double-blind randomization to fluoxetine (N=25) or placebo~     (N=25) in combination with optimized LDX for an additional 8 weeks. Participants will be~     monitored for clinical response and adverse events.~      Specific aims are:~      #1: To define youth meeting SMD criteria in terms of psychiatric comorbidity, neurocognitive~     functioning, and a potential bio-signature derived from electroencephalography (EEG).~      Specific hypotheses to be tested include: 1) that SMD participants will differ in comparison~     to non-SMD individuals in our pre-existing database on patterns of a) psychiatric~     comorbidity, b) symptoms, c) behavioral ratings, and d) neurocognitive functioning, and 2)~     that a distinct EEG bio-signature will be confirmed in individuals formally diagnosed with~     SMD.~      #2: To conduct a preliminary study of sequential pharmacotherapy for SMD with a stimulant~     followed by randomized, placebo-controlled selective serotonin re-uptake inhibitor (SSRI)~     therapy to evaluate the feasibility of recruitment and enrollment and assess the suitability~     of the proposed combination treatment as a basis for future clinical investigations.~      Specific hypotheses to be tested include: 1) that significant improvement in Clinical Global~     Impression - Improvement -SMD (CGI-I-SMD) scores and other secondary measures are evident~     after open-label LDX titration; 2) that participants randomized to fluoxetine will~     demonstrate additional significant improvement in CGI-I-SMD scores and other secondary~     measures in comparison to participants randomized to placebo; 3) that combination LDX and~     SSRI therapy is safe and well tolerated, and 4) that EEG profiles will normalize with~     treatment.~   "
141566|NCT01714297|"~     The purpose of this study is to determine if there are differences in clinical events, i.e~     bleeding with associated morbidity, if thromboprophylaxis with LMWH (Low Molecular Weight~     Heparin) is initiated before or after surgery.~   "
141567|NCT01714284|"~     This is a multicenter randomized controlled clinical trial evaluating the impact of a~     structured non pharmacological intervention consisting in intensive weight reduction~     (qualitative and quantitative changes in diet associated with physical exercise) compared to~     an intervention based on a simple informative counseling about the utility of weight loss for~     clinical control of psoriatic disease.~   "
141594|NCT01713933|"~     This study is an evaluation of the Ulthera® System used to treat the upper arms for~     improvement of brachial ptosis. All enrolled subjects will receive one bilateral upper arm~     treatment. Follow-up visits will occur at 60, 90 and 180 days post-treatment.~   "
141569|NCT01714258|"~     The two gold standard for cardiac output (CO) measurements, i.e., the Fick method and~     pulmonary artery thermodilution , are both invasive methods, requiring the use of central~     venous catheter and Swan-Ganz catheter, respectively.~      With the aim to reduce the risks for the patient, a big research effort has been made to~     investigate minimally invasive or non-invasive methods. Investigators sought to evaluate the~     effectiveness of a non invasive method to estimate CO in mechanically ventilated patients.The~     method is based on prolonged expiration, and relies on measurement of gas concentrations and~     flow rate. Investigators designed, realized, and characterized a system to induce passive~     prolonged expirations when connected to the patient circuit.~      CO is then calculated using an algorithm based a modified version of the Fick equation and~     the results are compared with the ones obtained by thermodilution.~      Several advantages can be introduced by the prolonged expiration technique: non-invasive~     measurement, easy implementation, independency from operator ability among others.~   "
141570|NCT01714245|"~     The purpose of this study is to determine if CLn BodyWash, a novel new gel cleanser~     formulated with surfactants and preserved with sodium hypochlorite, is effective at~     decreasing severity, body surface area and itching for patients with Atopic Dermatitis, or~     eczema.~   "
141571|NCT01714232|"~     The purpose of this study was to evaluate the performance of a Bayer Blood Glucose Monitoring~     System (BGMS) and four additional Blood Glucose Monitoring Systems (BGMS) from other~     manufacturers. All meter BG results were compared with plasma results obtained with a~     reference laboratory glucose method (YSI Glucose Analyzer).~   "
141572|NCT01714219|"~     Incontinence is one of the most common complications of radical prostatectomy. The continence~     rate is not significantly improved even by robot-assisted laparoscopic prostatectomy (RALP).~     However, some reports suggested that posterior reconstruction (PR) behind vesicourethral~     anastomosis could improve early recovery of continence during open, laparoscopic or~     robot-assisted radical prostatectomy.~      But, recent prospective studies reported no benefit of PR after RALP, which was the opposite~     result of those of previous studies. However the PR techniques used in these prospective~     studies seem to be quite different from the previous techniques. They seem to have used~     single-step PR, which opposes the median dorsal fibrous raphe (MDFR) only to the~     Denonvilliers' fascia (DF). By contrast, the original technique incorporated additional~     reconstruction between the MDFR and the posterior bladder wall 1-2 cm from the new bladder~     neck.~      Our group identified this anatomic structure as the posterior counterpart of the detrusor~     apron (PDA). The PDA is a strong, thick functional tissue containing muscle that is more~     appropriate for pulling and fixing the MDFR than the DF. As such, we hypothesized that the~     key proximal structure for PR is not DF, but rather PDA. Furthermore, single-step~     reconstruction between MDFR and PDA could be enough for PR. We previously investigated~     whether our new PR technique, which entails opposition of the MDFR solely to the PDA, would~     improve continence recovery compared with the standard RALP technique without PR. And our~     retrospective study demonstrated that this new PR technique during RALP significantly~     shortens the time to the recovery of continence compared with the standard technique, which~     does not incorporate PR (Int J Urol, 2012;19:683-7).~      Thus, we plan to validate this result by a well-designed, prospective, randomized controlled~     study.~   "
141573|NCT01714206|"~     The purpose of this study is to determine how multiple doses of canagliflozin (JNJ-28431754)~     affect the pharmacokinetics (ie, how the body affects the drug) of multiple doses of digoxin.~     The safety and tolerability of canagliflozin will also be assessed in healthy volunteers.~   "
141574|NCT01714193|"~     The purpose of this study is to investigate whether there is a drug-drug interaction between~     multiple doses of canagliflozin (JNJ-28431754) and single doses of an oral contraceptive~     containing ethinyl estradiol and levonorgestrel. The safety and tolerability of canagliflozin~     will also be assessed in healthy volunteers.~   "
141575|NCT01714180|"~     Studies have shown that different percentages of body fat can alter the way drugs are~     distributed in the body. This study will use blood samples taken at different time points for~     patients taking acyclovir to determine if higher body weights affect drug exposure. The~     information gathered from this study will help understand if patients with higher body~     weights need a different dosing plan.~      Patients receiving acyclovir as standard of care will be enrolled into this study. They will~     have blood draws once before they take acyclovir and 10 times after they take the acyclovir~     (over a total of 12 hours). These patients will be in the hospital already and will not need~     to make additional trips back to have blood drawn. A total of about 4—5 tablespoons of blood~     will be drawn for this study. 7 obese patients and 7 matched, non—obese patients will be~     enrolled into this study.~   "
141576|NCT01714167|"~     Stroke is one of the leading causes of disability in the world, and stem cell -~     transplantation provides a promising approach for rehabilitation. The main objective of this~     study is to evaluate the efficacy of the intracerebral injection of autologous bone marrow~     mesenchymal stem cells in patients with chronic stroke.~   "
141577|NCT01714154|"~     This multi-center, fixed-sequence, open-label, multiple-dose, 2-period study will evaluate~     the safety, tolerability and pharmacokinetics of setrobuvir alone or in combination with~     ritonavir-boosted danoprevir in subjects with mild hepatic impairment compared to healthy~     controls. All subjects will receive multiple doses of setrobuvir orally for 10 days in Period~     1 and multiple doses of setrobuvir plus ritonavir-boosted danoprevir orally for 10 days in~     Period 2, with a washout phase of at least 9 days between treatments.~   "
141578|NCT01714141|"~     This pilot study's main goal is to develop and preliminarily test a technology-based~     intervention to improve asthma medication adherence in urban African American emerging adults~     (ages 18-29). It is hypothesized that youth randomized to MCTI for adherence will show~     improvements in motivation to adhere to asthma medications and self-reported adherence~     compared to the comparison condition at 1- and 3- month follow up.~   "
141579|NCT01714128|"~     A significant number of all invasive breast cancers are hormone sensitive and may be~     candidates for treatment with hormonal therapy.~      This project will assess the ability and usefulness of imaging hormone-receptor status in~     breast cancer with positron emission tomography (PET) and 6α-[18F]fluoro-17β-estradiol (FES),~     an estrogen analogue in patients who are scheduled to be treated with hormonal therapy given~     in combination with a selective allosteric inhibitor of AKT protein kinase (MK2206) .~   "
141580|NCT01714115|"~     This is a single patient investigative treatment study. The patient was diagnosed with a~     retinal tumor in one eye. In the last 2 years, the patient has been treated with all~     available and conventional therapies, including intraocular injections of Avastin and~     Lucentis, steroids, and photodynamic therapy. Any positive results were short-term, and~     caused an eventual decline in central vision. Aflibercept has been shown to be effective~     against the growth of new vessels, secondary to macular degeneration. This study proposes~     that it may also be more effective in treating this particular patient and case. The study~     treatment plan is for 6 months initially, with the intention to continue treatment.~   "
141581|NCT01714102|"~     Metabolic syndrome is a serious health condition that affects about 35 percent of adults and~     places them at higher risk of cardiovascular disease, diabetes, stroke and diseases related~     to fatty buildups in artery walls. The underlying causes of metabolic syndrome are obesity,~     being overweight, physical inactivity and genetic factors. In recent decades, the prevalence~     has increased dramatically in the United States. Lifestyle interventions including dietary~     modification, physical activity and weight loss form the basis of treatment for these~     patients. However, research has shown that even when people are able to incorporate these~     changes, they often revert back to their usual lifestyle resulting in weight gain and~     continued risk for diabetes and heart disease.~      Resveratrol, a natural plant derived compound found in grapes, peanuts and red wine, has been~     found to reverse some of the features of the metabolic syndrome (insulin resistance, high~     triglycerides, high blood pressure) in rodents. These improvements occurred without weight~     loss, and were proven to be a direct result of resveratrol ingestion. Other studies reveal~     improvement in cardiovascular health, tumor suppression, and longevity. However, there are~     few studies investigating these beneficial effects in humans. Investigators propose to prove~     that resveratrol, administered to subjects with the metabolic syndrome, under controlled~     conditions of weight stability, common diet, and strict compliance with the study drug, will~     improve the symptoms of the metabolic syndrome, thereby decreasing the chance of developing~     diabetes or heart disease.~   "
141582|NCT01714089|"~     The purpose of this study is to determine whether RNS60 is effective in the treatment of~     RR-MS compared to interferon beta-1a.~   "
141583|NCT01714076|"~     Observational cohort study in children hospitalized for acute bronchiolitis. Patients are~     nursed in cohort isolation. Aim is to investigate the incidence and clinical impact of~     co-infections in this group.~   "
141584|NCT01714063|"~     The primary objective of this study is to determine ex vivo the amount of fluticasone~     deposited onto a filter (delivered dose) interposed between the OptiChamber Diamond VHC~     mouthpiece and the subject's mouth during coordinated and uncoordinated actuation/inhalation~     maneuver.~   "
141585|NCT01714050|"~     Major depression is a highly prevalent, chronic, and debilitating mental health problem with~     significant social cost that poses a tremendous economic burden. Winter seasonal affective~     disorder (SAD) is a subtype of recurrent major depression involving substantial depressive~     symptoms that adversely affect the family and workplace for about 5 months of each year~     during most years, beginning in young adulthood. This clinical trial is relevant to this~     public health challenge in seeking to develop and test a time-limited (i.e., acute treatment~     completed in a discrete period vs. daily treatment every fall/winter indefinitely), palatable~     cognitive-behavioral treatment with effects that endure beyond the cessation of acute~     treatment to prevent the annual recurrence of depression in SAD.~      Aim (1) To compare the long-term efficacy of cognitive-behavioral therapy (CBT) and light~     therapy on depression recurrence status, symptom severity, and remission status during the~     next winter season (i.e., the next wholly new winter season after the initial winter of~     treatment completion), which we argue to be the most important time point for evaluating~     clinical outcomes following SAD intervention.~      Hypothesis: CBT will be associated with a smaller proportion of depression recurrences, less~     severe symptoms, and a higher proportion of remissions than light therapy in the next winter.~     The study is designed to detect a clinically important difference between CBT and light~     therapy in depressive episode recurrences during the next winter, the primary endpoint, in an~     intent-to-treat analysis.~      Aim (2) To compare the efficacy of CBT and light therapy on symptom severity and remission~     status at post-treatment (treatment endpoint).~      Hypothesis: CBT and light therapy will not differ significantly on post-treatment outcomes.~   "
141586|NCT01714037|"~     Part A of this study will investigate the Maximum Tolerated Dose of Debio 0932 in combination~     with standard of care chemotherapy for the first- and second-line treatment of advanced~     NSCLC.~   "
141587|NCT01714024|"~     The purpose of this research study is to compare the healing differences of two metals~     (trabecular vs. standard titanium) that are used for dental implants. In addition;~     investigators will be examine these differences in the gene expression profiles in subjects~     with three conditions associated with delayed healing: diabetes and osteoporosis.~      The study will last at least 11 weeks consisting of 6 appointments. All visits will be~     carried out at the GO Health Center within the UNC School of Dentistry. Visits will last~     between 30 minutes to 3 hours depending on the particular visit.~      The visits will consist of: Obtaining consent, doing a health history, measuring vital signs,~     doing dental exams of the teeth and gums, collecting samples of saliva dental radiographs~     (X-rays), a teeth cleaning, having 4 temporary mini test cylinders placed in areas of the~     lower jaw where teeth are missing and implant surgery to place up to four permanent implants.~   "
141588|NCT01714011|"~     Introduction:~      Schizophrenia is a serious mental illness. For majority of patients it is a lifetime~     condition,characterized by intermittent episodes of hospitalization due to relapse or acute~     symptom exacerbation. The nature and course of the disorder impose significant social and~     economic burden. Relapse is costly, with hospitalization accounting for a substantial portion~     of healthcare expenses. Second generation antipsychotic side effect such as metabolic~     syndrome and diabetes mellitus will contribute additional costs to the treatment.~      Many studies have since then provided convincing evidence for a high risk of diabetes and~     other glucose abnormalities, metabolic syndrome and mortality due to elevated cardiovascular~     risk in patients with schizophrenia.~      However many studies has shown the effectiveness and safety of aripiprazole and~     ziprazidone.In one of the study, aripiprazole showed improvement of negative schizophrenic~     symptoms by 25% and 50% of functioning level from baseline. In term of safety, antipsychotics~     considered to have a safer metabolic profile were amisulpride, ziprasidone and aripiprazole.~      Study objectives:~        -  To investigate the safety and efficacy of ziprazidone versus aripiprazole in the~          treatment of schizophrenia patients with metabolic syndrome and diabetes mellitus.~        -  To investigate the reversibility of metabolic syndrome and diabetes parameters following~          the treatment with ziprazidone versus aripiprazole.~      Hypotheses:~      * The proportion of reversibility of metabolic syndrome and diabetes parameters is higher~     following the treatment of ziprazidone than aripiprazole.~   "
141589|NCT01713998|"~     Up to 60 subjects will be enrolled. Enrolled subjects will receive one Ulthera® treatment on~     the face and neck. Follow-up visits will occur at 90 and 180 days post-treatment. Study~     images will be obtained pre-treatment, immediately post-treatment, and at each follow-up~     visit.~   "
141595|NCT01713920|"~     A majority of Korean doctors tend to add other antihypertensive rather than to titrate the~     same drug.~      However, we try to induce doctors to titrate the Sevikar than to add other antihypertensive~     if patients are not controlled with Sevikar 5/20mg(amlodipine 5mg + omlesartan 20mg). As~     above, for patients who are not controlled with Sevikar 5/20mg, doctors will proceed to other~     prescription pattern with other choices of titration to Sevikar 5/40, 10/40mg.~      It is important to evaluate BP lowering efficacy of Sevikar through the titration step in~     patients uncontrolled with Sevikar low dose. Thus, this study is designed to demonstrate the~     efficacy of Sevikar by titration in patients who are not controlled their BP with low dose of~     Sevikar.~   "
141596|NCT01713907|"~     Up to 15 subjects will be enrolled. Enrolled subjects will receive one Ulthera® treatment on~     the face and neck. Follow-up visits will occur at 45, 90 and 180 days post-treatment. Study~     images will be obtained pre-treatment, immediately post-treatment, and at each follow-up~     visit.~   "
141597|NCT01713894|"~     The purpose of this study is to assess in a pilot randomized controlled trial the following~     PICOT question: In parents facing extreme premature delivery, does the use of an existing~     validated visual decision aid as compared to standard counseling, reduce the primary outcome~     of parental decisional conflict? Furthermore, is such a decision aid understood and~     applicable across differing populations of different ethnic backgrounds and social classes?~   "
141598|NCT01713881|"~     This will be a retrospective chart review of 880-1000 patients who had a colonoscopy and were~     found to have a tubular adenoma between the years of 2004-2008. We will compare the rate and~     timing of completion of repeat colonoscopies pre and post establishment of a polyp registry~     (tracking system) in 2006. Each group will be composed of up to 500 subjects consecutively~     identified from all the patients who underwent colonoscopy and were found to have a tubular~     adenoma (Group 1-2004 to 2006, Group 2 2007-2008).~   "
141599|NCT01713868|"~     The goal of this proposal is to address serious and ongoing challenges related to adherence~     to public health recommendations known to reduce the risk of SIDS. Adherence has reached a~     plateau at an unacceptably low level both in the overall US population and especially in~     Black infants leading to a halt in the decline in infant mortality and a widening in the~     racial disparity in infant mortality. The current proposal is a collaborative effort that~     will capitalize on the extensive experience of the investigators in studying barriers to~     adherence to safe sleep practices to develop two complementary, culturally competent,~     intervention strategies and to test the effectiveness of each strategy as well as both~     strategies in combination. Innovative aspects of the Social Media and Risk-reduction Training~     of Infant Care Practices (SMART) study include its: 1) unique collaboration of leaders in the~     field; 2) leveraging of the currently operational infant care practices study infrastructure~     and hospitals; 3) use of two complementary interventions with the potential for synergistic~     impact; 4) use of social marketing strategies;5) use of mobile technology (mHealth) to~     deliver messages; and 6) collaboration with community resources and expertise. The SMART~     study will have four arms in which 16 hospitals are randomly assigned to one of the following~     study groups: 1) Safe Sleep Nursery Education and Breastfeeding mHealth messaging; 2)~     Breastfeeding Nursery Education and Safe Sleep mHealth messaging; 3) Safe Sleep Nursery~     Education and Safe Sleep mHealth messaging; 4) Breastfeeding Nursery Education and~     Breastfeeding mHealth messaging. A total of 1600 mothers will be recruited (100/hospital),~     with 400 in each study group. The primary aim is to assess the effectiveness of the~     interventions aimed at promoting safe sleep practices compared with the breastfeeding control~     interventions. The secondary aim is to assess potential mediating factors that may explain~     the intervention effects on infant care practices and that may inform areas for future~     improved intervention approaches. With the successful completion of the SMART study,~     effectiveness data will have been provided for two interventions to improve adherence to safe~     sleep practices that are practical to disseminate nationally in multiple diverse settings.~   "
141600|NCT01713855|"~     The purpose of this study is to determine how children with a history of severe, chronic~     Idiopathic Thrombocytopenic Purpura (ITP) who were treated with rituximab might respond to~     vaccines. Eligible patients are previously or currently enrolled in a study entitled Open~     Label, Phase I/II Trial of Rituximab for Chronic, Severe Idiopathic Thrombocytopenic Purpura~     in Children and Adolescents and have decided to obtain an inactivated influenza vaccination.~     These patients will be invited to provide one blood sample prior to vaccination and a second~     sample following vaccination to quantify immune response to vaccination.~   "
141601|NCT01713842|"~     Phase 1:~      Patients are treated with infusions of Tocilizumab (TCZ) for 3 months. Clinical evaluation is~     performed using PMR-AS.~      The PMR-AS is computed by summing the 5 variables after multiplying by 0.1 for weighting~     purposes: PMR-AS (activity scale = AS) = C reactive protein (CRP) (mg/dl) + patient scale~     (VASp) (0-10 scale) + physician scale (VASph) (0-10 scale) + morning stiffness(MST)~     [min]×0.1) + elevation of upper limbs (EUL) (0-3 scale).~      At the end of the phase 1,the patients stop TCZ and entered in phase 2 at week 12.~      Phase 2:~      All the patients are included in the phase 2 and treated with glucocorticoid (GC)for 3~     months. Two arms are possible according to the PMR-AS. Either the classical GC treatment~     (0.3mg/kg), either a low dose group of GC(0.15mg/kg) .~   "
141602|NCT01713829|"~     The purpose of this study is to determine the extent to which consuming a cranberry beverage~     modifies immune function, specifically related to γδ T cells and other innate immune cells.~     It is hypothesized that cranberry components will interact with immune cells to activate~     signaling pathways that enhance cell function. Enhanced immune cell function should result in~     reduced number, duration, and severity of cold and flu symptoms.~   "
141603|NCT01713816|"~     Antioxidants are important for having a good memory and for smart thinking when people get~     old, and that is important for everyone's quality of life. This research will find out if~     normal aging and Alzheimer's disease use up brain antioxidants. It will develop a new imaging~     tool that can help doctors to stop cognitive decline.~   "
141604|NCT01713803|"~     This is a randomized, double blind, placebo controlled study in opioid dependent subjects.~     Subjects meeting entry criteria will be treated with multiple doses of B-BNX or B-Placebo,~     with non-responders rescued within 6 hours. Open treatment B-BNX will be administered as~     follow-up therapy. Clinical efficacy assessments include the clinical opioid withdrawal scale~     (COWS), subject-rated assessments, and a urine drug screen.~   "
141605|NCT01713790|"~     This study aims to examine long term effects in the training gain stage of the falls~     management exercise programs (FaME, from Skelton and Dinan) over 10 weeks on physical~     functional performance after mechanical SR-WBV, dance therapy and strength training~     intervention in a frail elderly population.~   "
141637|NCT01713374|"~     The purpose of this study is to determine whether interventions aimed at increasing~     sympathetic tone modify endothelial function measures as assessed by the measurement of~     flow-mediated dilation (FMD) and constriction (FMC). The investigators hypothesize that the~     three interventions under study will increase FMC while causing a blunting in FMD.~      Further, the investigators plan to study the circadian variability of FMC and FMD. The~     investigators hypothesize a peak of FMD in the late hours of the day and a peak of FMC in the~     early hours.~   "
141606|NCT01713777|"~     The United States Food and Drug Administration (FDA) has specific rules generic drug~     companies must follow to get a generic copy of a seizure medication approved. Currently, the~     FDA approves generic drugs by requiring studies on normal volunteers who don't have epilepsy~     and who take just one dose of the generic drug followed by a series of blood tests. Some~     people with epilepsy and their physicians have complained about side effects or loss of~     seizure control when taking generic drugs, but no one knows if these complaints are truly~     because of problems with the generic drugs.~      When the FDA tests generic copies of lamotrigine (LTG), the blood levels measured after~     volunteers receive the generic lamotrigine tablets are allowed to fall within a specific~     range. This research will test whether two different manufacturer's generic lamotrigine, that~     fall in different parts of that range, perform in a similar way when given to people with~     epilepsy every day over a several week period. The two products will be called GENERIC A and~     GENERIC B.~      The generic forms of the study drug lamotrigine to be tested in this study are approved by~     the FDA for the treatment of seizures.~   "
141607|NCT01713764|"~     The study is a small pilot, designed to provide data regarding the feasibility and~     acceptability of conducting such a study on a larger scale. The present study is a randomized~     controlled clinical trial comparing two mindfulness-based lifestyle modification programs to~     help people manage diabetes and lose weight, one using on a low-carbohydrate diet (LC) and~     the other using a moderate-carbohydrate diet promoted by the American Diabetes Association~     (ADA). Intervention content will include information about nutrition (carbohydrate~     restriction or American Diabetes Association recommended diet) and emotion regulation and~     mindful eating strategies.~   "
141608|NCT01713751|"~     The aim of this study is to determine the surgical site infection rate and patient~     satisfaction for subcuticular versus interrupted mattress suture in closure of skin at~     Cesarean delivery in obese patients.~   "
141609|NCT01713738|"~     The purpose of the study is to evaluate the safety and efficacy of rituximab in children ages~     18 months to 18 years, who have severe, chronic ITP. Eligible patients with either primary or~     secondary ITP are treated with rituximab once a week for 4 doses, and then followed for up to~     one year. Response is defined as having a platelet count greater than or equal to 50,000/mL~     on four consecutive weekly measures beginning anytime in weeks 9 - 12.~   "
141610|NCT01713725|"~     Chronic urticaria can be defined as the occurrence of widespread daily or almost daily wheals~     for at least 6 weeks, which may be accompanied by angioedema. While the wheals are transient,~     the resolution of angioedema is slower than wheals and could take up to 72 hours. The natural~     course of chronic urticaria is self-limited, with spontaneous remissions and occasional~     relapses. The investigators calculated a 0.6% (95% CI(Confidence Interval): 0.4-0.8)~     prevalence in a population study. It has a great impact on patients' quality of life. In a~     recent national survey on patients attending Allergy Department, chronic urticaria was the~     disease with greater impact on mental quality of life out of all allergic diseases.~      In spite of the high morbidity of this disease and the impact in quality of life, there is no~     available treatment. Last guidelines recommend initiating treatment with antihistamine and if~     there is no response to increase the dose off-label up to four-fold; systemic corticosteroids~     are also recommended in short tapering and if no response, the only treatment with clinical~     evidence to be employed is cyclosporine. As additional data, the treatment cost of this~     disease has been calculated in 2047$/year.~      In past years it has been employed the monoclonal humanized anti-Immunoglobulin IgE (iGE)~     antibody (Omalizumab) to treat moderate to severe asthma with good results. The rationale for~     this approach in chronic urticaria is that Omalizumab inhibits the binding of IgE to the high~     affinity IgE receptor (FceRI) which decreases the FceRI expression on the surface of mast~     cells and basophils so that immunoglobulin G cross linking of the alpha subunit and basophil~     degranulation is prevented.The hypothesis the investigators are working on is that monoclonal~     IgE antibody Omalizumab could be effective in controlling chronic urticaria symptoms in~     patients non respondent to conventional therapy. The investigators hypothesize that~     Omalizumab is able to revert the basophil or mast cell activation present in chronic~     urticaria.~   "
141611|NCT01713712|"~     The purpose of this study is to evaluate the effect of access to nutrition services on~     pregnancy outcomes in the obese urban population. There are many studies that have shown that~     obesity has a negative impact on pregnancy. However, currently there are only a few small~     studies that specifically look at ease of access to nutrition services in an obese urban~     population and the effect this has on maternal weight gain and pregnancy outcomes. This study~     will compare two groups of pregnant women with a BMI of 30 or greater. The investigators~     hypothesize that access to nutritional services will lead to decreased weight gain during~     pregnancy and improved pregnancy outcomes.~   "
141612|NCT01713699|"~     The purpose of this study is to determine whether the quantitative detection of circulating~     tumor cells (CTCs) in patients with Epcam expressing tumors can be used compared to standard~     qualitative method - cytology both in the cerebrospinal fluid of patients, clinically~     suspected for leptomeningeal metastases.~   "
141613|NCT01713686|"~     This is prospective, multi-center clinical trial. Enrolled subjects will receive one Ulthera®~     treatment on the decolletage. Follow-up visits will occur at 90 and 180 days following~     treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at~     each follow-up visit.~   "
141614|NCT01713673|"~     Up to 20 subjects will be treated. Subjects will receive two (2) bilateral Ultherapy™ or Sham~     treatments of the axilla. The study hypothesis is that subjects who receive Ultherapy™~     treatment will have a greater reduction in axillary sweating compared to subjects receiving~     Sham treatments. Follow-up visits will occur at 7 and 14 days following treatment #1, and at~     7, 14, 30, 60 and 90 days following treatment #2. At each follow-up visit, assessments will~     be completed to compare the amount of axillary sweating compared to baseline.~   "
141615|NCT01713660|"~     The IntraLase iFS femtosecond laser system can create corneal arcuate incisions for cataract~     surgery.~   "
141616|NCT01713647|"~     To assess the bioequivalence of the investigational TEST product with the marketed REFERENCE~     products by measurement of Plasma concentrations of Amlodipine ,Losartan, Carboxylic acid~     losartan metabolite & Hydrochlorothiazide in plasma and calculation of the bioequivalence~     parameters from those measurements followed by ANOVA and 90% confidence interval statistical~     evaluation.~   "
141638|NCT01713361|"~     The purpose of this study is:~        -  To assess the safety and efficacy profile of ISIS-FXIRx, including incidence of bleeding~          and VTE, in patients undergoing total knee arthroplasty.~        -  To compare the efficacy and safety profile of ISIS-FXIRx in patients who achieve less~          than or equal to 0.2 U/mL FXI activity levels to that of enoxaparin.~   "
141825|NCT01710904|"~     This non-interventional, observational study is set up on request of the Belgian~     reimbursement authorities and evaluates the efficacy of Targinact with regard to pain relief~     and constipation in daily clinical practice in Belgium compared to the previous analgesic~     treatment with prolonged release oxycodone. Only patients eligible for Targinact®~     reimbursement in Belgium are included.~   "
141617|NCT01713634|"~     Bone loss is not only a well-documented effect of spaceflight on astronauts, but also a~     condition that affects millions of men and women on Earth each year. Many countermeasures to~     bone loss have been proposed, and many have been evaluated to some degree. To date, those~     showing potential have focused on either exercise or pharmacological interventions, but none~     have targeted dietary intake alone as a factor to predict or minimize bone loss during~     spaceflight. The investigators proposed to document how the ratio of acid precursors to base~     precursors in the diet is related to directional changes in markers of bone resorption and~     formation during flight and recovery from flight. There is a high likelihood for success in~     predicting the extent of bone loss from dietary intake patterns of astronauts during~     spaceflight, given that this concept is strongly anchored in data obtained from ground-based~     experiments in our laboratory and others. The notion of manipulating diet to minimize bone~     loss could also have significant social and economic impacts for NASA and for the general~     public - especially given the increasing trends for diets that are high in animal protein and~     low in fruits and vegetables. The results of the proposed experiments will lead to~     development of a dietary countermeasure for bone loss consisting of a balanced diet with no~     associated risks for side effects that might be present with pharmaceuticals or supplements,~     no requirement for payload mass, and no additional crew time necessary during flight.~   "
141618|NCT01713621|"~     This study aims to investigate the concentration dependent effects of OZ439 on the clearance~     of P. falciparum parasites in patients, specifically the determination of an in-vivo minimum~     inhibitory concentration (MIC) of OZ439. Characterisation of PK-PD~     (Pharmacokinetic-Pharmacodynamic) relationships is essential for rational evidence based~     dosing. The adaptive investigation of a range of doses will provide the best chance of~     accurate PK-PD characterisation, allowing the observation of Plasmodium falciparum growth~     dynamics and the subsequent identification of MIC and MPC (minimum parasiticidal~     concentration). Additionally the tolerability and pharmacokinetics of OZ439 will be~     confirmed. The PK/PD relationship between OZ439 exposure and subsequent effects on~     parasitaemia will be investigated.~   "
141619|NCT01713608|"~     A randomised, placebo-controlled, dose-escalation study to investigate safety and toleration~     of OZ439 OD for 3 days to healthy male and female volunteers. The study aims:~        -  To determine the safety and tolerability of ascending doses of OZ439 OD for three days.~        -  To assess pharmacokinetic parameters of ascending doses of OZ439 given OD.~        -  To identify the maximum tolerated dose of OZ439 administered.~   "
141620|NCT01713595|"~     To determine if an inhaled hypertonic saline solution has any effect on lung function in~     patients with acute respiratory distress syndrome (ARDS).~   "
141621|NCT01713582|"~     The primary purpose of this study is to determine the recommended dose (RD) of OTX015/MK-8628~     for further phase II studies, in participants with acute leukemias (acute myeloid leukemia~     [AML; de novo and secondary to a myelodysplastic syndrome] or acute lymphoblastic leukemia~     [ALL]) or hematologic malignancies (diffuse large B cell lymphoma [DLBCL] or multiple myeloma~     [MM]).~   "
141622|NCT01713569|"~     Up to 6 subjects will be enrolled. Subjects who have already chosen to have a surgical~     facelift procedure will be enrolled. Subjects will receive selective Ulthera® ultrasound~     exposures in the pre-auricular regions. Subject will return for a follow-up visit up to 48~     hours post-treatment, on the day of their rhytidectomy. Study images will be obtained~     pretreatment, immediately post-treatment, and at the follow-up visit.~   "
141623|NCT01713556|"~     The purpose of this study is to test whether propranolol, when given during a re-evocation of~     a traumatic memory, is capable of reducing subsequent PTSD symptoms associated with that~     memory.~   "
141624|NCT01713543|"~     Background: Falls are the leading cause of injury among older adults in Singapore, but falls~     among the elderly can be preventable and the risks are predictable. Translating this~     understanding of falls etiology into an integrated clinical and public health program that is~     accessible to the elderly is a critical health services delivery challenge.~      Hypothesis: An evidence-based program of screening, risk modification and physical therapy~     delivered in a community setting will reduce recurrent falls incidence among a high-risk~     group of elderly recently discharged to the community.~      Methodology: This randomized controlled trial targets patients seen at Emergency Department~     (ED) for a fall or fall-related injuries who are at least 65 years old and will be discharged~     to home. Upon signing the informed consent form, the participants will be followed up for~     nine months from the baseline assessment during which the participants are randomized into~     either a control or the intervention group. The participants in the intervention group will~     be provided with a multifactorial program of screening, risk modification and physical~     therapy focused on progressive strength, balance, and gait training either as an~     individualized program or a group setting in the community for the first three months from~     the date of randomization. The number of recurrent falls will be monitored via a falls~     prevention diary maintained by (or for) each participant.~   "
141625|NCT01713530|"~     This trial is conducted in Africa, Europe and the United States of America (USA).~      The aim of the trial is to compare the difference in change in glycosylated haemoglobin~     (HbA1c) between insulin degludec/insulin aspart (IDegAsp) and/or oral anti-diabetic drugs~     (OADs) and insulin degludec (IDeg) plus insulin aspart (IAsp)and/or OADs.~   "
141626|NCT01713517|"~     The purpose of the study is to determine whether long lasting insecticidal nets and indoor~     residual insecticide spraying, alone or in combination, are effective for controlling~     insecticide resistant anopheles mosquitoes for malaria prevention.~   "
141627|NCT01713504|"~     The purpose is to characterize new hypereosinophilic syndrome biomarkers more informative and~     more accessible compared to those that we have already thanks to a proteomic approach. This~     will help the investigators to diagnose the this disease.~   "
141639|NCT01713348|"~     To understand if Multiple Daily Injections (MDI) managed subjects can improve glycaemic~     control by;~        1. regularly checking and understanding Continuous Glucose data & trend arrows at times~          other than the standard pre-meal bolus calculation test times and~        2. review of their glucose profiles (inc. hypoglycaemic risks) with their Health Care~          Professional (HCP) and adjusting behaviours & therapy from interpretation of the~          Continuous Glucose profiles.~   "
141831|NCT01710826|"~     To assess in healthy adult subjects:~        -  The tolerability and safety of ascending repeated oral doses of Genz-682452.~        -  The pharmacokinetic parameters of Genz-682452 after ascending repeated oral doses.~        -  The pharmacodynamics of Genz-682452 after ascending repeated oral doses.~   "
141628|NCT01713491|"~     At the acute stage of cerebral ischaemia, the only effective drug that increases the~     proportion of patients who survive without dependency is thrombolytic therapy by intravenous~     (i.v.) tissue-plasminogen activator (t-PA). This treatment is entered into routine practice~     with similar results than in trials, in various places of the world including Europe and~     Japan.~      Stroke and dementia are closely related. About one patient in ten has dementia before a~     first-ever stroke, and more than one in three has dementia after a recurrent stroke.~     Pre-existing dementia is associated with a worse outcome of stroke, and pre-existing~     cognitive impairment without dementia is associated with a higher rate of~     institutionalisation within 3 years. In many patients cognitive impairment is due to the~     summation of the effects of vascular and Alzheimer lesions of the brain.~      More and more patients nowadays who are eligible for rt-PA are already known as demented at~     admission. A retrospective study conducted in a cohort of patients with dementia who had an~     ischaemic stroke and were treated by rtPA suggested that there is no increased risk of~     cerebral bleeding and death as compared with non demented patients. However, pre-existing~     cognitive impairment is possibly associated with (i) an increased risk of bleeding in~     patients with cognitive impairment, and (ii) a higher sensitivity to the neurotoxic effect of~     rt-PA on the brain tissue.~      Japanese patients differ from European patients by a higher risk of spontaneous intracranial~     haemorrhage, and a higher proportion of patients with small-vessel diseases.~      The primary objective of the OPHELIE-COG study is to determine whether ischaemic stroke~     patients who are treated with i.v. rt-PA are more likely to have a poor outcome (defined as a~     modified Rankin scale 2 to 6 at month 3) in the presence of pre-existing cognitive impairment~     or dementia. The secondary objectives are to determine whether (i) they have an increased~     risk of symptomatic intracerebral haemorrhages, (ii) the proportion of patients who have a~     poor outcome is lower than expected from the placebo group of randomised trials for patients~     with a similar range of baseline severity, and (iii) the influence of the cognitive state on~     outcome differs between Japanese and European patients.~   "
141629|NCT01713478|"~     The prevalence of hepatic cirrhosis in Romania is very high, with a 10-year mortality of~     34-66%. Upward trend of mortality is observed. It is known that cirrhosis is associated with~     cardiac abnormalities. These can induce several complications of cirrhosis, and increase~     postoperative mortality. Therefore, it is a major public health issue and research in this~     field should be a priority.~      Few studies evaluated the cardiac function in cirrhotic patients, using only conventional~     echocardiography. However, this allows only the late diagnosis of cardiac dysfunction, which~     might be already irreversible. Consequently, description of new parameters, which could~     detect early dysfunction, becomes essential. There is no study designed to estimate intrinsic~     myocardial properties in cirrhosis. New methods (Tissue Doppler and Speckle-tracking~     echocardiography) could be essential to detect early cardiac dysfunction. The exact role of~     biological markers in the diagnosis of cardiac dysfunction remains to be clarified. Impaired~     cardiac function coupled with augmented vascular function could be the model for cirrhotic~     patients. This type of ventriculo-arterial interaction has never been described.~      The main objectives of our project are:~        1. to investigate the mechanisms which lead to cardiac dysfunction;~        2. to describe new parameters for the early diagnosis of cirrhotic cardiomyopathy;~        3. to describe the type of ventriculo-arterial interaction;~        4. the association between biological markers and echo parameters.~   "
141630|NCT01713465|"~     The objective of the proposed study is to design and evaluate a touch screen computer based~     multi-factorial intervention to educate individuals at risk of Metabolic syndrome in diverse~     Indian settings including urban, rural and slum in the State of Bhubaneshwar. The study~     objective is to improve metabolic syndrome related knowledge, attitude and practices among~     individuals using the proposed interactive, bilingual computer based educational program.~   "
141631|NCT01713452|"~     Stoma closure has been associated with a high rate of surgical site infection (SSI). The rate~     for SSI following stoma closure has been noted to be 7-41%; a rate that is higher than~     expected for a clean-contaminated operative classification. The ideal stoma site closure~     technique is still debated in the current literature. The aim of this study was to compare~     the rate of SSI following two different stoma closure techniques, primary closure versus a~     skin approximating purse string closure, in a multi-center randomized controlled trial. The~     investigators hypothesize that purse string closure technique will have a lower rate of SSI~     than primary closure technique.~   "
141632|NCT01713439|"~     The patient's have neuroblastoma that has come back, or not gone away. The cancer is harder~     to treat now. The investigators would like the patient's to be in this research study to~     determine the safety and dosage of special cells that may make the patient's own immune~     system fight the cancer. To do this the investigators will put two special genes into~     neuroblastoma cancer cells that have been grown in the lab. The genes put in make the cancer~     cells produce lymphotactin, a natural substance that attracts immune system cells to the~     cancer, and IL-2 a natural substance that may help the immune system kill cancer cells. Some~     of these cells will then be put into the patient's body. Studies of cancers in animals and in~     cancer cells that are grown in laboratories suggest that substances like lymphotactin and~     IL-2 do help the body kill cancer cells. A treatment similar to this has been used in twelve~     children previously and similar treatments are being used in adults with other cancers. This~     is a research study. The investigators do not know the best amount of special cells to use,~     so different children will get different numbers of cells.~      The purpose of this study is to learn the side effects and safe dosage of these special~     cells. Participation in this study will last for 15 years.~   "
141633|NCT01713426|"~     This study is comparing the efficacy and tolerability of Qutenza with that of pregabalin in~     patients suffering from peripheral neuropathic pain. Treatment allocation will be to one of~     these treatments and the duration of the study will be about 10 weeks (assuming that from~     screening to treatment allocation takes 2 weeks). Participants will be asked to complete~     questionnaires about various aspects relating to their condition throughout the study.~      This study will include subjects suffering from Postherpetic Neuralgia, Peripheral Nerve~     Injury or Non Diabetic peripheral polyneuropathy.~   "
141634|NCT01713413|"~     The Oxymizer pendant® is a special oxygen cannula that can be used to supply high flow long~     term oxygen therapy. It is compatible with a wide variety of oxygen sources. In a reservoir,~     the Oxymizer® stores pure oxygen so that the concentration of inhaled oxygen is increased.~      The aim of this study is to investigate the potential benefit of the Oxymizer® with regard to~     the blood oxygenation during exercise testing. Given that the endurance time is very~     sensitive for little changes in exercise capacity, this test will be used to show the~     difference between the Oxymizer® and a conventional nasal cannula regarding exercise duration~     at 70% of peak Watt and oxygenation.~      The tests will be accompanied by blood gas analysis, partial pressure of carbon dioxide and~     heart rate.~   "
141635|NCT01713400|"~     To determine whether treatment with ustekinumab will alter the ratio of T Regulatory Cell~     (Treg)/total cluster of differentiation 4 (CD4)+ cells in peripheral blood at day 30~     post-hematopoietic cell transplantation (HCT).~   "
141636|NCT01713387|"~     To decide maximum tolerated dose and recommended dose of treatment using gemcitabine plus S-1~     combination therapy in patients with biliary tract cancer undergoing resection without major~     hepatectomy~   "
141640|NCT01713335|"~     The aim of this study was to evaluate kallikreins and its substrate, CCN, in COPD patients.~     Kallikreins are a subgroup of serine proteases, enzymes which are able to cleave peptide~     bonds in proteins. Kallicrein profile is unkonwn in COPD. The investigators will assess~     Kallikrein 1 to 15 and CCN 1 to 6 in sputum of patients. Three groups of patients will be~     included: Healthy smoker subjects, stable COPD patients and COPD patients with acute~     exacerbation. Kallicrein levels in sputum will be compared in these groups.~   "
141641|NCT01713322|"~     Immunization procedures are a common source of iatrogenic pain for infants. A recently~     developed clinical practice guideline, led by Taddio et al., created evidence-based~     strategies for management of immunization pain. User-friendly educational tools outlining~     these strategies were made. The goal of cluster randomized controlled trial is to assess~     whether these educational materials increase utilization of pain-relieving strategies by~     parents during infant immunizations.~   "
141642|NCT01713309|"~     This is a study of plasma HBP -levels of a previously published trial of G-CSF in critically~     ill patients (Pettila et al. Critical Care Medicine 2000). The original study was a~     prospective, randomised, double-blind, placebo-controlled trial of filgrastim in patients~     with acute respiratory failure requiring intubation. In this substudy, the investigators~     evaluated the effect of filgrastim on HBP -concentrations in critically ill patients.~   "
141643|NCT01713296|"~     Investigators propose to study the single agent activity of pazopanib in a Phase II trial of~     patients with relapsed or refractory small cell lung cancer. Because these patients have very~     limited treatment options, use of an investigational agent in this patient population is~     supported by current National Comprehensive Cancer Network guidelines. Using correlative~     biologic studies to evaluate the anti angiogenic activity of pazopanib in the absence of~     concomitant chemotherapy will allow us to delineate the responses due to this drug and the~     effect on angiogenesis.~      Pazopanib dose has been determined to 800 mg once daily per the initial recommended dose~     approved by FDA and EMA, as monotherapy in advanced Renal Cell Carcinoma~   "
141644|NCT01713283|"~     This study is to evaluate the safety, tolerability, and antiviral activity of sofosbuvir~     (SOF) with ribavirin (RBV) in Egyptian adults with chronic genotype 4 hepatitis C virus (HCV)~     infection.~   "
141645|NCT01713270|"~     To study whether renal sympathetic denervation(RSD) is safe and effective in patients with~     drug-resistant hypertension and symptomatic atrial fibrillation.~   "
141646|NCT01713257|"~     This study intends to investigate the clinical outcomes of a new immunoenhancing formula~     which composed arginine free compare to isonitrogenous, isocaloric standard formula in ICU~     patients.The study design is multicenter, double-blind randomized controlled study with 3~     periods of Screening, Run-in and Randomization period.~      Primary Objective: To evaluate the clinical outcomes of immunoenhancing diet (IED) arginine~     free in medical-surgical ICU patients.~      Secondary Objective: To evaluate the immunologic effects and safety of IED arginine free~     formula.~   "
141647|NCT01713244|"~     RFA has become a standard method in the treatment of small HCC(≤2 cm) due to its ease of use,~     safety, cost-effectiveness, and minimal invasiveness. It can ablated and blocked the small~     vessels while destroyed the tumor cell in situ. Surgical resection is the most widely~     accepted treatment for the patients with advanced hepatocellular carcinoma in the Asian~     countries. But the effectiveness of hepatectomy was depressed because of the high recurrence~     rate. The spreading of the cancer cell along the portal vein or the hepatic vein system~     during the operation account for the tumor recurrence. Using RFA to ablate and block the~     small vessels around the tumor before resection will reduce the spreading of the cancer cell.~     Investigators hypothesized that the RFA assisted hepatectomy might result in lower recurrence~     rate than hepatectomy alone in the treatment of advanced HCC. Thus, the purpose of this study~     was to prospectively compare the effects of RFA assisted hepatectomy with hepatectomy alone~     for the treatment of advanced HCC.~   "
141648|NCT01713231|"~     -  Overall Objective: To test the hypothesis that oral vitamin D supplementation at higher~          than currently prescribed doses has a beneficial effect on the skeleton of young~          patients with osteogenesis imperfecta (OI).~        -  Specific Aims: 1. To determine whether 12 months of high-dose vitamin D supplementation,~          compared to standard-dose vitamin D supplementation, increases areal bone mineral~          density z-scores at the lumbar spine. 2. To examine the effectiveness of high-dose~          vitamin D supplementation to increase trabecular and cortical bone mineral density at~          the radius. 3. To examine whether high-dose vitamin D supplementation has an effect on~          physiological determinants of bone mass (parathyroid hormone, activity of bone~          metabolism, muscle function).~        -  Background: In a preliminary cross-sectional study of 282 OI patients we observed an~          inverse relationship between serum 25-hydroxyvitamin D and parathyroid hormone levels~          and a positive relationship between circulating levels of 25-hydroxyvitamin D and lumbar~          spine areal bone mineral density z-scores. This suggested that high-dose vitamin D~          supplementation would have a beneficial effect on bone density. Most OI patients~          currently receive oral vitamin D supplementation of 400 International Units per day, but~          doses of 2000 International Units per day are safe and have been shown to be beneficial~          in studies on healthy adolescents.~        -  Study Design: This is a parallel-group double-blind randomized controlled trial of 12~          months duration on 60 children and adolescents aged 6 to 19 years with a clinical~          diagnosis of OI. One group of 30 participants will be randomized to receive vitamin D3~          at a dose of 2000 international units per day ('high-dose group'). The other group of 30~          participants will be randomized to receive vitamin D3 at a dose of 400 international~          units per day ('standard-dose group'). Randomization will be stratified according to~          pubertal status and bisphosphonate treatment status.~        -  Clinical Relevance: The proposed study aims at direct improvements in the care of OI~          patients. If a simple and low-cost 'intervention' such as high-dose vitamin D~          supplementation can be shown to be effective in relieving some of the disease burden~          associated with OI, the benefit to OI patients worldwide would be substantial.~   "
141649|NCT01713218|"~     Pancreatic ductal adenocarcinoma (PDAC) has one of the worst prognoses of all human cancers~     and is considered as a sanctuary, resistant to most of the drugs used. Identification of new~     molecular targets involved in its pathogenesis is urgently needed and required both proper~     and innovative efficacy assessment.~      This proof-of-concept trial is studying the dynamic tumor response after the administration~     of a short course (4 weeks) neoadjuvant combination of gemcitabine and a Hedgehog inhibitor~     (Vismodegib) before surgery in patients with operable pancreatic cancer.~   "
141650|NCT01713205|"~     The purpose of this study is to evaluate a clinically and economically most effective~     diagnostic algorithm for prediction of post-traumatic complications in a multicenter sample~     of severe trauma patients.~   "
141651|NCT01713192|"~     The purpose of this registry is to obtain perioperative data in patients undergoing cardiac~     surgery and find out relations between the data and investigate several causes affecting~     postoperative complications.~   "
141652|NCT01713179|"~     Ambroxol is a metabolite of bromhexine and possesses mucokinetic and secretolytic properties~     that are also found in mucolytic agents.1 Ambroxol has been used for decades for the~     treatment of respiratory disorders associated with excessive mucus, including chronic~     inflammatory pulmonary conditions, bronchitis, and pneumonia.2,3 The drug changes the~     biophysical properties of secretions by degrading the mucin polymers, deoxyribonucleic acid,~     fibrin in airway secretions, and by generally decreasing viscosity.4 In addition, ambroxol~     increases cyclic nucleotide (cAMP or cGMP),5 which can theoretically increase tear~     secretion.6 Many systemic medications, such as antihistamines, antidepressants, diuretics,~     acne drugs, and certain blood pressure medicines can cause or exacerbate a dry eye.7,8 On the~     other hand, several topical medications, including mucolytics such as ambroxol and~     bromhexine, may be used to treat tear-deficient dry eyes by promoting lacrimal gland~     function.9 However, the effects of mucoactive agents on the tear film have not been~     investigated systemically, and mucoactive agents may have a disturbing effect on the tear~     film because they modify mucin.10,11 The tear film is composed of 3 unique layers, including~     the outermost lipid layer, the middle aqueous layer, and the innermost mucus layer; this~     structure enables it to perform many functions.12 The lipid layer acts as a barrier to~     prevent tear film evaporation, and the aqueous layer supplies oxygen and important nutrients~     to the cornea.13 The mucin layer, secreted mostly by conjunctival goblet cells, coats the~     corneal surface rendering it hydrophilic, and anchors the tear film to the corneal surface.14~     Deficiencies in the amount of tear production or alteration in tear composition can lead to~     ocular surface disease.15 Although many studies have focused on aqueous-deficient dry eye~     syndrome,16-18 the effect of mucin layer defects on the tear film has not been thoroughly~     studied. Furthermore, very few reports have determined the effects of oral mucolytic agents~     on the tear film and ocular surfaces, although a study has reported that filamentary~     keratopathy was treated with debridement of filaments and application of topical mucolytic~     agents such as acetylcysteine eyedrops. In the present study, we investigated the effects of~     oral ambroxol on tear film and ocular surface.~      Reference~        1. Malerba M, Ragnoli B. Ambroxol in the 21st century: pharmacological and clinical update.~          Expert Opin Drug Metab Toxicol 2008;4:1119-1129.~        2. Rubin BK. Mucolytics, expectorants, and mucokinetic medications. Respir Care~          2007;52:859-865.~        3. Rogers DF. Mucoactive agents for airway mucus hypersecretory diseases. Respir Care~          2007;52:1176-1193.~        4. Gupta PR. Ambroxol - Resurgence of an old molecule as an anti-inflammatory agent in~          chronic obstructive airway diseases. Lung India 2010;27:46-48.~        5. Anfossi G, Russo I, Massucco P, et al. Adenosine increase human platelet levels of cGMP~          through nitric oxide: possible role in its antiaggregating effect. Thromb Res~          2002;105:71-78.~        6. Gilbard JP, Rossi SR, Heyda KG, et al. Stimulation of tear secretion by topical agents~          that increase cyclic nucleotide levels. Invest Ophthalmol Vis Sci 1990;31:1381-1388.~        7. Gayton JL. Etiology, prevalence, and treatment of dry eye disease. Clin Ophthalmol~          2009;3:405-412.~        8. Terry MA. Dry eye in the elderly. Drugs Aging 2001;18:101-107.~        9. Calonge M. The treatment of dry eye. Surv Ophthalmol 2001;45:227-239.~       10. Yamada T, Takemura Y, Niisato N, et al. Action of N-acylated ambroxol derivatives on~          secretion of chloride ions in human airway epithelia. Biochem Biophys Res Commun~          2009;380:586-590.~       11. Hasegawa I, Niisato N, Iwasaki Y, et al. Ambroxol-induced modification of ion transport~          in human airway Calu-3 epithelia. Biochem Biophys Res Commun 2006;343:475-482.~       12. Antti H, Tuulikki S, Matej O. Human tear fluid lipidome: from composition to function.~          PLoS One 2011;6:e19553.~       13. Ohashi Y, Dogru M, Tsubota K. Laboratory findings in tear fluid analysis. Clin Chim Acta~          2006;396:17-28.~       14. Davidson HJ, Kuonen VJ. The tear film and ocular mucins. Vet Ophthalmol 2004;7:71-77.~       15. Bhavsar AS, Bhavsar SG, Jain SM. A review on recent advances in dry eye: pathogenesis~          and management. Oman J Ophthalmol 2011;4:50-56.~       16. Patel S, Farrell J, Blades KJ, et al. The value of a phenol red impregnated thread for~          differentiating between the aqueous and non-aqueous deficient dry eye. Ophthalmic~          Physiol Opt 1998;18:471-476.~       17. Lin H, Li W, Dong N, et al. Changes in corneal epithelial layer inflammatory cells in~          aqueous tear-deficient dry eye. Invest Ophthalmol Vis Sci 2010;51:122-128.~       18. Yokoi N, Yamada H, Mizukusa Y, et al. Rheology of tear film lipid layer spread in normal~          and aqueous tear-deficient dry eye. Invest Ophthalmol Vis Sci 2008;49:5319-5324.~   "
141653|NCT01713166|"~     The purpose of this study is to compare the effects of crystalloid and colloid, which are~     used for pump priming solution, on the microcirculatory alterations during cardiac surgery.~   "
141655|NCT01713140|"~     Background:~      Progressive strength training is a training modality used in rehabilitation after total knee~     arthroplasty (TKA). Strength deficits up to 80% in the quadriceps muscle is shown to be~     present in the operated leg after TKA, which relates to reduced central nervous system (CNS)~     activation of the muscle. As increased CNS activation occurs during strength training when~     muscular fatigue is approaching in healthy subjects, it is relevant to investigate if this~     also is the case after TKA. The clinical implication is that repetitions performed to~     contraction failure during strength training, may help reduce CNS activation deficits of the~     quadriceps muscle after TKA.~      Purpose:~      The aim of this study is to investigate CNS activation of the quadriceps muscle during~     strength training performed with repetitions to contraction failure after TKA.~      Method:~      Electromyographic (EMG) activity of the vastus medialis (VM), vastus lateralis (VL),~     semitendinosus (ST) and biceps femoris (BF) muscles will be recorded during knee extensions~     performed in a knee extension machine until contraction failure. The relative loading will be~     10 repetition maximum (RM). The absolute load (kilograms) corresponding to 10 RM is defined a~     minimum of 3 days before the day where the EMG-data are recorded. The primary outcomes will~     be normalized EMG amplitude and median power frequency for each 10th (10%, 20%, 30% failure,~     etc.) of the set to failure.~      Hypothesis:~      Based on previous findings in healthy subjects, we hypothesize that in patients with a TKA,~     the EMG amplitude will increase while the median power frequency will decrease during a~     strength training set performed to contraction failure after TKA.~   "
141656|NCT01713127|"~     The purpose of this study is to evaluate efficacy of remifentanil in preterm infants during~     ventilator care with remifentanil and to analyze pharmacokinetics in preterm infants~   "
141657|NCT01713114|"~     The primary objective of this study is to assess the acute effects of different meals on~     satiety. It is hypothesized that a lower carbohydrate meal will result in greater feelings of~     satiety and reduced food intake at a subsequent meal compared to the higher-carbohydrate or~     meal skipping conditions.~   "
141658|NCT01713101|"~     This study is to see whether the early intravenous administration of tranexamic acid improves~     the outcome of acute upper gastrointestinal bleeding.~   "
141659|NCT01713088|"~     To evaluate whether Multisystemic Therapy (MST) is more effective in reducing youth offending~     and out-of-home placement in a large, ethnically diverse, urban U.K. sample than an equally~     comprehensive management protocol; to determine whether MST leads to broader improvements in~     youth sociality and in mediators believed to be responsible for change in MST.~   "
141660|NCT01713075|"~     The purpose of the investigation is to confirm the safety and efficacy in long-term use of~     Symbicort Turbuhaler in patients with Chronic obstructive pulmonary disease (COPD) under the~     post-marketing actual use.~   "
141661|NCT01713062|"~     The purpose of this randomised prospective multicenter longterm study is to evaluate the~     survival rate of the implant, wear and periprosthetic osteolysis of highly cross-linked~     polyethylene with and without addition of Vitamin E (UHMWPE-XE vs. UHMWPE-X) in Total Hip~     Arthroplasty.~   "
141662|NCT01713049|"~     The purpose: To investigate the diagnostic accuracy of 18F-FLT PET for the suspicious lesions~     on mammograms and ultrasound.~   "
141663|NCT01713036|"~     This is a Phase 1, open-label, single centered trial to evaluate the mass balance,~     bioavailability and metabolism of pimasertib in cancer subjects with locally advanced or~     metastatic solid tumors.~   "
141664|NCT01713023|"~     -  BACKGROUND: Individuals with diabetes report innate preference for sweet foods, possibly~          due to genetic variants. In addition, studies have shown that ingestion of fructose~          promotes lower postprandial blood glucose, compared to glucose. However, excessive~          intake may increase triglycerides, uric acid and oxidative stress, due to oxidative~          priority.~        -  AIMS: To investigate the influence of fructose and glucose and taste receptor, type 1,~          member 2 (TAS1R2) in glucose, triglycerides, uremia, oxidative stress, feelings related~          to food intake and palatability of individuals with type 1 diabetes.~        -  METHODS: The trial is a single-blind, two-way crossover (1-week washout) study in 30~          subjects with type 1 diabetes. Blood samples were collected before and 2-hours after the~          participants receive 75g of fructose or 75g of glucose dissolved in 200 ml water.~          Capillary blood glucose were assessed at 30, 90, 120, and 180 minutes to determine~          glucose, and visual analogue scales for measurement of appetite sensation were assessed~          at 70, 120, and 190 minutes.~        -  PURPOSE: The research proposal adds knowledge about the TAS1R2 (Ile191Val) polymorphism~          and around the most suitable monosaccharide for individuals with diabetes type 1.~   "
141665|NCT01713010|"~     The purpose of this study is to evaluate physiological variables to the decision about the~     appropriate time to discontinuation of mechanical ventilation in patients with traumatic~     brain injury. It is expected that these variables are effective in predicting the outcome of~     weaning from mechanical ventilation.~   "
141666|NCT01712997|"~     Previous studies suggest that combinations of existing therapies may be effective for~     pulmonary arterial hypertension (PAH). However, all of these studies are sequential~     combination therapy, for example, by adding sildenafil to previously prescribed bosentan.~     This kind of therapy model is not enough for PAH patients, especially those with New York~     Heart Association (NYHA) class Ⅲ and Ⅳ. In this randomized, multicenter study, the~     investigators evaluate the safety and efficacy of combining inhaled iloprost, a prostacyclin~     analog, with the endothelin receptor antagonist bosentan in treatment naive patients with PAH~     by comparing with bosentan monotherapy. Efficacy endpoints include change from baseline in~     6-min-walk distance (6-MWD), modified (NYHA) functional class, hemodynamic parameters, and~     time to clinical worsening.~   "
141715|NCT01712347|"~     This multicenter observational study will evaluate the efficacy and safety of first-line~     bevacizumab (Avastin) in combination with fluoropyrimidine-based chemotherapy in participants~     with metastatic colorectal cancer (mCRC). Participants for whom the treating physician has~     decided to initiate first-line fluoropyrimidine based chemotherapy in combination with~     bevacizumab will be observed for approximately 4 years.~   "
141826|NCT01710891|"~     Randomized controlled trial of intubation using the C-MAC video laryngoscope versus standard~     laryngoscopy. Patients who are going to be intubated using standard laryngoscopy will be~     randomized to have their first intubation attempt done using either standard laryngoscopy or~     the C-MAC video laryngoscope. Subsequent attempts will be at the discretion of the treating~     physician.~   "
141667|NCT01712984|"~     The aim of the study is to demonstrate safety and immunogenicity of the quadrivalent~     influenza intradermal (QIV-ID) vaccine compared to the trivalent influenza vaccine (TIV)~     containing the B strain from the primary (Yamagata) lineage (TIV-ID1) and the trivalent~     influenza vaccine containing B strain from the alternate (Victoria) lineage (TIV-ID2)~     vaccines in producing protection against four strains of influenza virus.~      Primary Objective:~        -  To demonstrate that QIV-ID induces an immune response (as assessed by hemagglutination~          inhibition (HAI) geometric mean titers (GMTs) and seroconversion rates) that is~          non-inferior to responses induced by TIV-ID1 and TIV-ID2 for the 4 virus strains at 28~          days post-vaccination.~      Secondary Objectives:~        -  To demonstrate that each B strain in QIV-ID induces an immune response (as assessed by~          HAI GMTs and seroconversion rates) that is superior to the response induced by the~          TIV-ID that does not contain the corresponding B strain.~        -  To describe the rate of post-vaccination seroprotection induced by QIV-ID and TIV-ID.~        -  To describe post-vaccination immunogenicity stratified by age (18-49 years and 50-64~          years), race, ethnicity, gender, previous vaccination status, and baseline~          seropositivity status.~        -  To describe the safety profile for subjects who receive QIV-ID and TIV-ID.~      Observational Objectives:~        -  To demonstrate non-inferiority of QIV-ID compared to TIV-ID in terms of all Grade 2 or~          Grade 3 solicited systemic reactions combined~        -  To demonstrate non-inferiority of QIV-ID compared to TIV-ID in terms of all Grade 3~          solicited injection site reactions combined.~   "
141668|NCT01712971|"~     The incidence of complications after standard open pancreaticoduodenectomy for pancreatic or~     peri-ampullary tumours is around 50%. The amount of intra-operative blood loss is an~     important factor that determines the occurrence of postoperative complications. Therefore,~     any significant reduction of intra-operative blood loss will benefit the peri-operative~     course.~   "
141669|NCT01712958|"~     Colorectal cancer (CRC) is the third most common cancer and the fourth leading cause of~     cancer-related death in the world. Despite potentially curative surgery and the use of modern~     adjuvant chemotherapy, up to 40% of CRC patients subsequently develop local tumor relapse or~     metastatic disease. Currently, aside from post-operative pathological staging, early follow~     up of the patients does not include a specific test or any other evaluation that could~     predict disease recurrence. Therefore, exploring and identifying novel biomarkers of CRC's~     following diagnosis of the primary tumor may help us in identifying patients at high risk for~     recurrence.~      Modifications in signaling pathways and their regulation by microRNAs (miRNAs) are being~     evaluated as biomarkers and therapeutic targets for cancer in general and CRC in particular.~     It has been established, although not completely, that miRNAs have a role in initiation and~     progression of CRC. Modifications of miRNAs have been recorded in CRC tumors, and the~     expression patterns of these miRNAs could in principle biomark this cancer's phenotype. As~     miRNAs are well documented to regulate critical molecules in signaling pathways, their~     regulation of tumor relevant pathways may also serve to further sub-classify patients into~     drug responsive groups. Moreover, miRNAs may be sampled from peripheral blood and are~     available as a non-invasive diagnostic method, their application as biomarkers is of special~     interest.~      In this study the investigators aim to quantify miRNA levels in human colon and rectal~     tumors, tumor adjacent and normal tissues. By comparing this data from a large cohort of~     patients, the investigators aim to identify specific, relevant miRNAs that may serve as~     biomarkers to stratify CRC patients according to their clinical characteristics such as~     disease stage, specific treatment, prognosis and disease recurrence.~   "
141670|NCT01712945|"~     The purpose of this study is to test a novel strategy to prevent the clinical problem of~     secondary autoimmunity following alemtuzumab treatment of multiple sclerosis.~      The hypothesis is that autoimmunity after alemtuzumab can be prevented by giving a drug that~     promotes thymic T cell regeneration (Palifermin, Kepivance®).~   "
141671|NCT01712919|"~     The investigators will add weekly cetuximab (c225) to the standard care of chemoradiation~     against locoregionally advanced Nasopharyngeal Carcinoma (NPC), and evaluate the toxicity and~     efficacy of this new regimen.~   "
141672|NCT01712906|"~     Mumps is an acute infectious respiratory disease caused by the mumps virus (MuV), which~     occurs mainly in children and adolescents. Its main clinical symptoms were parotid gland~     suppurative swelling and pain with fever. The pathological changes and harm caused by mumps~     was not only confined to the parotid gland, on the contrary, the social harm caused by~     serious complications cannot be ignored. As mumps is a vaccine-preventable infectious~     disease, vaccination is a fundamental strategy for controlling mumps. So far, there are 13~     genotypes of MuV. Based on the analysis of molecular epidemiology, the main epidemic strain~     of MuV in China was the F genotype. The commonly used vaccine strains represented only a~     small number of known genotypes, e.g. Jeryl-Lynn (JL) and Rubini strains, which belong to~     type A, Urabe strain belongs to type B, and L-Zagreb strains belongs to type D. Virus seed of~     Live Attenuated Mumps Vaccine (Human diploid cell) developed by the institute was SP-A~     strain, which was the first separation and preparation of the attenuated mumps viruses in~     China. SP-A belongs to F genotype, which was the domestic epidemic genotype. In addition, the~     cell substrate prepared for vaccine was human diploid cell (KMB-17 strain), which is much~     safer to use. The preliminary test results showed that the vaccine possessed good~     immunogenicity and good antigenic cross-reactivity. The application of this vaccine will~     provide more effective means to prevent and control of mumps epidemic.~   "
141673|NCT01712893|"~     The present study is a randomized open-label -phase III study that aims to compare the~     efficacy and safety of the adjuvant chemotherapy with simultaneous or sequential application~     of Zoladex up to 2-3 years for ≤ 45 year old premenopausal hormone receptor-positive breast~     cancer.~   "
141674|NCT01712880|"~     The purpose of this study is to determine the success rate of two treatments for infection~     after total hip replacement: single stage arthroplasty exchange (your surgeon will take out~     your original implants and replace them with a complete new set) compared to irrigation and~     debridement with modular exchange (your surgeon will clean your implants with a surgical~     solution and take out the plastic liner and replace it with a new one - the rest of your hip~     implants will stay in place). The goal is to see if one is better than the other for the~     treatment of hip infection after a total hip replacement. A successful treatment means that~     you did not have to have another surgery on your hip for an infection-related reason.~   "
141675|NCT01712867|"~     The primary objective is to determine the efficacy of phytosterol esters of omega-3 (Vayarol)~     versus Omega-3 acids ethyl esters in reducing triglyceride levels in hypertriglyceridemia~     patients with fasting triglyceride levels ≥ 200 and < 500 mg/dL.~   "
141827|NCT01710878|"~     Safety and performance of an anti-microbial vascular graft in the treatment of aneurysmal and~     occlusive disease of the abdominal aorta.~   "
141676|NCT01712854|"~     The purpose of this study is to investigate how budesonide/formoterol fumarate dihydrate~     (Symbicort ©) affects dynamic hyperinflation in patients with obstructive disease using~     Optoelectronic Plethysmography (OEP). This study is unique as it will be the first~     randomized, doubleblind, crossover study with a placebo inhaler and budesonide/formoterol~     fumarate dihydrate as the intervention which will evaluate the effects on ventilatory~     mechanics through the use of OEP. The investigators plan to demonstrate that~     budesonide/formoterol fumarate dihydrate impacts dynamic hyperinflation which can be detected~     with OEP, and that budesonide/formoterol fumarate dihydrate may have an effect in the short~     term on exercise capacity during a constant load exercise test. The changes in ventilatory~     mechanics measured after budesonide/formoterol fumarate dihydrate by OEP will provide a~     unique evaluation of budesonide/formoterol fumarate dihydrate in a controlled setting also~     demonstrating the utility of OEP in evaluating of the effects of a medical treatment on~     hyperinflation in individuals with chronic obstructive lung disease (COPD).~        1. Primary Objective/Hypothesis: Our objective is to measure baseline, post treatment and~          post exercise spirometry and evaluate exercise dynamic hyperinflation before and after~          treatment using OEP. The investigators hypothesize that budesonide/formoterol fumarate~          dihydrate will decrease dynamic hyperinflation as measured by OEP.~        2. Primary Endpoint: Our primary endpoint is the change in dynamic hyperinflation,~          specifically end expiratory volumes, dynamic lung volumes and diaphragmatic paradoxical~          breathing as measured by OEP.~        3. Secondary Objective: Our secondary objective is to evaluate duration of steady state~          exercise and exercise capacity before and after treatment. Our secondary hypothesis is~          that decreases in dynamic hyperinflation during exercise will lead to improvements in~          dyspnea with exercise, and allow for increases in exercise capacity.~        4. Secondary endpoint: Exercise time, change in Borg scale at rest vs. Borg scale at steady~          state vs. Borg at end exercise.~   "
141677|NCT01712841|"~     Age-related macular degeneration (AMD) is the most prevalent cause of vision loss in~     developed countries and is often discussed in terms of the dry and the wet forms. The~     wet form of AMD is the more advanced form of the disease and is responsible for 80% of the~     legal blindness in AMD. Treatment options include a promising class of biologics called~     anti-vascular endothelial growth factors, as well as photodynamic therapy and laser surgery.~     These therapies can slow further vision loss, but cannot achieve recovery of lost vision. The~     wet form of AMD is always preceded by the dry form. Therefore, it is reasonable to expect~     that the early detection and treatment of the dry form may help reduce vision loss or~     progression to the more damaging wet form. Unfortunately, symptoms appear only in advanced~     stages of the dry form. As light sensitive cells in the macula breakdown in a process~     called geographic atrophy, the patient may notice blurred central vision.~      OCT is an imaging technology that can perform non-contact cross-sectional imaging of retinal~     and choroidal tissue structure in real time. It is analogous to ultrasound B-mode imaging,~     except that OCT measures the intensity of reflected light rather than acoustical waves.~      This study aims is to use OCT technology to compare how the retinal anatomy and blood flow~     differ within three severity groupings of non-exudative age-related macular degeneration~     (NEAMD).~   "
141678|NCT01712828|"~     To find out if the blood level of lenalidomide can be changed when a drug that prevents~     p-glycoprotein (a protein naturally present in the body that helps carry substances across~     cell membranes that is found in many parts of the body like the intestines, liver, and~     kidneys) from working (called a P-gp inhibitor) when taken together with lenalidomide. The~     study is also trying to find out if blood level of temsirolimus can be changed when a subject~     takes lenalidomide together with temsirolimus.~   "
141679|NCT01712815|"~     This phase I trial studies the side effects of positron emission tomography (PET)/computed~     tomography (CT) in evaluating response to chemotherapy in patients with breast cancer.~     Comparing results of diagnostic procedures done before, during, and after chemotherapy may~     help doctors predict a patient's response to treatment and help plan the best treatment.~   "
141680|NCT01712802|"~     To establish evidence based guidelines for denture adhesives (powder and cream), multicenter~     cross over randomized clinical trial will be carried out.~      The null hypotheses are that there are no difference on improvement from baseline to post~     application of two adhesives powder and cream, in terms of general satisfaction, oral related~     quality of life, masticatory function and oral conditions.~   "
141681|NCT01712789|"~     The primary purpose of the study is to evaluate the safety and efficacy and to generate PK~     and biomarker data for the combination of pomalidomide and low-dose dexamethasone in patients~     with refractory or relapsed and refractory multiple myeloma.~      The study consists of a Screening phase within 28 days prior to cycle 1 day 1, a Treatment~     phase and a Follow-up phase which starts within 28 days of discontinuation from study~     treatment, every 3 months for up to 5 years.~      In addition, the collection of steady-state PK data from a large population will enable~     robust population PK and assess Pomalidomide exposure response analyses.~      The exploratory objectives of the study are to investigate potential markers predictive of~     POM response or resistance and pharmacodynamic markers.~   "
141682|NCT01712776|"~     To determine the efficacy and safety of vapocoolant spray (Pain Ease Medium Stream) in~     decreasing the pain of venipuncture (blood draw)~   "
141683|NCT01712763|"~     The long acting GnRH antagonist degarelix will be tested for the treatment of women with~     endometriosis recurrence compared with classical GnRH analog treatment. Pain symptom~     disappearance and disease free time during follow-up will be the outcomes for establishing~     which medical treatment is the best in endometriosis recurrence treatment.~   "
141684|NCT01712750|"~     Tissue oxygen saturation (StO2) and its recovery during a vascular occlusion test (VOT) will~     be measured in elective cardiac surgery patients undergoing cardiopulmonary bypass using a~     non-invasive near infrared spectrometry (NIRS) machine. The purpose of this study is to~     determine whether changes in VOT measurements occur in patients during cardiac surgery.~   "
141685|NCT01712737|"~     No studies have reported the effect of pre-meal snacking on raisins compared to other~     commonly consumed snacks on energy intake in children. Therefore, the objective of the~     current study was to examine appetite and energy intake following consumption of ad libitum~     snack of raisins, grapes or mix of almonds and raisins, compared with a water control, on~     appetite and food intake 30 min later in 8 - 11 y old normal weight children. The~     investigators hypothesized that raisins would lower subsequent energy intake in children and~     reduce hunger.~   "
141686|NCT01712724|"~     Both aerobic training (AT) and resistance/strength training (RT) have the potential to~     improve recovery after stroke. Research conducted in chronic disease and healthy populations~     suggest that AT and RT combination therapy may produce synergistic and superior effects~     along cognition and mobility domains, when compared to AT alone. However, the effects of a~     combined training approach (AT+RT) compared to AT alone has not been investigated in people~     post-stroke.~   "
141687|NCT01712711|"~     The aim of study was to evaluate the effect of helicobacter pylori eradication on liver fat~     content, liver function tests, lipid profile, homeostasis model assessment-IR (HOMA-IR)~     index, and anthropometric measurements (body mass index and waist circumference)in diabetic~     subjects with non-alcoholic fatty liver disease.~   "
141688|NCT01712698|"~     Acute changes in axial diffusivity will correlate with the severity of injury in patients~     that suffer an acute spinal cord injury.~   "
141689|NCT01712685|"~     Background:~      - The drug 18F-VM4-037 is being tested for use in cancer imaging studies. It may help tumor~     tissue show up more clearly during scans. Researchers want to see how well it works for scans~     for people who have kidney cancer.~      Objectives:~      - To test the safety and effectiveness of 18F-VM4-037 during imaging studies of kidney~     cancer.~      Eligibility:~      - Adults at least 18 years of age with kidney cancer that will be treated with surgery.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected.~        -  Participants will have two positron emission tomography (PET) scans of their kidneys.~          They will have the scans before and after receiving an injection of 18F-VM4-037. The~          scans will take about 2 hours to complete.~        -  About 3 weeks after the PET scans, participants will provide tumor tissue samples from~          their kidneys.~        -  This is a scanning study only. Treatment will not be provided as part of this study.~   "
141690|NCT01712672|"~     Background:~      - Dental plaque is a coating of bacteria on the teeth. It contributes to poor dental health~     and diseases such as gingivitis, cavities and periodontal disease. Researchers who study~     plaque know that many different types of oral bacteria stick to each other in test-tube~     experiments. However, it is not clear if these interactions occur in natural dental plaque.~     By studying how bacteria interact, researchers can better understand how bacteria come~     together and grow to form plaque.~      Objectives:~      - To look at how bacteria interact with one another to form dental plaque.~      Eligibility:~      - Healthy nonsmoking volunteers at least 18 years of age.~      Design:~        -  Participants will be screened with a medical history and dental exam. They will also~          have dental impressions taken for a stent (a device similar to Invisalign(SqrRoot)~          braces).~        -  Participants will wear the stent for up to 8 hours a day on selected study visit days.~          It will contain enamel chips made from sterilized human teeth. The mouth bacteria will~          stick to the chips and grow. Chips will be taken out of the stent twice during these~          study visit days.~        -  Participants will have other study visits to provide saliva and plaque samples. They~          will also have gum swabs to collect bacteria.~        -  Some participants may have a second set of study visits. At these visits, they will chew~          gum to increase their saliva production. Afterwards, they will wear the stent with the~          enamel chips for 4 hours. Samples from the stent will be taken once on these study visit~          days.~   "
141691|NCT01712659|"~     Background:~        -  The human T-cell leukemia virus 1 (HTLV-1 causes adult T-cell leukemia (ATL). Infection~          does not immediately cause ATL, but it can develop over time. ATL is a rare and~          aggressive type of cancer that disrupts the body s ability to control the HTLV-1 virus.~          It also affects the growth and reproduction of cells infected with the virus.~        -  Ruxolitinib is a drug that has been approved to treat bone marrow disorders. It can~          interfere with the proteins that are important to the development and growth of ATL~          cells. Drugs like ruxolitinib may be able to interrupt important activity in ATL cells.~          Researchers want to see if ruxolitinib can be a safe and effective treatment for ATL.~      Objectives:~      - To test the safety and effectiveness of ruxolitinib for adult T-cell leukemia.~      Eligibility:~      - Individuals at least 18 years of age who have ATL caused by HTLV-1.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Imaging studies will also be performed.~        -  Participants will take ruxolitinib twice a day for 28 days. They will have blood tests~          on days 1, 14, and 28. These tests will look at the levels of HTLV-1 in the blood.~          Participants will have a final blood test about 2 weeks later. Treatment will also be~          monitored with imaging studies.~        -  Participants who have a partial response during treatment may be able to start taking~          ruxolitinib again after the final blood test. They will continue to take ruxolitinib for~          as long as it is effective and the side effects are not severe.~        -  Participants who have a full response during treatment will take ruxolitinib for 56 more~          days, and then stop treatment. If ATL returns, they may restart treatment and continue~          it for as long as it is effective.~   "
141692|NCT01712646|"~     Background:~      - Oxytocin is a chemical that the brain normally produces. It plays an important part in the~     way humans and other animals act in social and emotional situations. Adults with~     schizophrenia have been studied to see if oxytocin can reduce some symptoms of schizophrenia,~     such as hearing voices, feeling suspicious, and not feeling interested in daily life. These~     studies show that oxytocin may help. However, it has not been studied in children who develop~     schizophrenia. Researchers want to see if oxytocin, given as a nasal spray, is safe and can~     reduce schizophrenia symptoms in children.~      Objectives:~      - To see if an oxytocin nasal spray can reduce schizophrenia symptoms in children.~      Eligibility:~      - Children above 10 years of age who have childhood-onset schizophrenia, and have~     schizophrenia symptoms in spite of taking medication.~      Design:~        -  This study will last 4 weeks. Participants will stay in the hospital for the entire~          period of the study. Participants may also have an extra 2 weeks of study medication and~          1 week of testing immediately following the initial 4 weeks.~        -  Participants will be screened with a physical exam and medical and psychiatric history.~          They will provide blood and urine samples, and have imaging studies of the brain. They~          will also have tests to look at their social and emotional functioning. These tests will~          take 1 week to perform.~        -  Participants will have either oxytocin or placebo nasal spray twice daily for 2 weeks.~        -  At the end of the 2-week period with nasal spray, there will be 1 week with no nasal~          spray. All the tests of week 1 will be repeated.~        -  The optional extra 3 weeks (2 weeks with oxytocin and one week for testing) will be~          similar to the second, third, and fourth weeks of the study. All participants will have~          oxytocin during this period.~   "
141693|NCT01712633|"~     Background:~      - Functional magnetic resonance imaging (fMRI) is used to study the brain. It takes a series~     of pictures that can be used to look at how the brain processes information. It is used to~     study problems with thinking, language, and movement, among other things. Researchers are~     working to develop new and better fMRI techniques. To test these techniques, they want to~     perform fMRI scans on healthy volunteers.~      Objectives:~      - To test different fMRI techniques in healthy volunteers.~      Eligibility:~      - Healthy volunteers at least 18 years of age.~      Design:~        -  Participants will be screened with a physical exam and medical history.~        -  Participants will have fMRI scans of the brain. During these scans, they will be asked~          to perform simple tasks. These tasks may involve language, thinking, or motor skills.~          The scanning sessions will last up to 2 hours.~        -  Participants may be asked to return for additional fMRI scans over several years.~   "
141716|NCT01712334|"~     This phase IV, multicenter, randomized, open-label, two-period crossover study will evaluate~     the comparable efficacy and safety of Pulmozyme (dornase alfa) delivered by the eRapid~     nebulizer system in patients with cystic fibrosis. Patients who have been receiving Pulmozyme~     once daily chronically for at least 6 months will continue to receive Pulmozyme once daily~     for a run-in period of 2 weeks using the Pari LC Plus nebulizer. Patients will then be~     randomized to receive in a crossover design Pulmozyme once daily for two treatment periods of~     2 weeks each using either the Pari LC Plus or the eRapid nebulizer. Anticipated time on study~     treatment is 6 weeks.~   "
141717|NCT01712321|"~     The purpose of this study is to determine whether Vilazodone is effective in the treatment of~     symptoms of Social Anxiety Disorder among adults.~   "
141718|NCT01712308|"~     The goal of this clinical research study is to learn if sotatercept can help to control~     MPN-associated myelofibrosis and anemia. The safety of this drug will also be studied.~      This is an investigational study. Sotatercept is not FDA approved or commercially available.~     It is currently being used for research purposes only.~      Up to 60 patients will take part in this study. All will be enrolled at MD Anderson.~   "
141694|NCT01712620|"~     Background:~      - High blood pressure in the lungs, known as pulmonary arterial hypertension (PAH), is a rare~     disorder. In spite of recent advances in treatment, the death rate remains unacceptably high.~     Lung blood vessel function can be harmed by progressive injuries, such as inflammation,~     leading to worsening of the disease. A drug called spironolactone has been known to improve~     blood vessel function and reduce inflammation. Some people with PAH take spironolactone to~     help treat fluid retention. However, its effect on inflammation and blood vessel function in~     patients withPAH is not known. Researchers want to see if spironolactone can help these~     conditions in people with PAH.~      Objectives:~      - To test the effectiveness of spironolactone in treating pulmonary arterial hypertension.~      Eligibility:~      - Individuals at least 18 years of age with pulmonary arterial hypertension.~      Design:~        -  This study will last for 24 weeks. Participants will be screened with a physical exam~          and medical history. Blood and urine samples will be collected.~        -  Participants will take either spironolactone or a placebo. They will take their study~          drug or placebo for 7 weeks. Treatment will be monitored with regular blood tests.~        -  In Week 8, participants who have had no reaction to the treatment will receive a higher~          dose of the drug or placebo.~        -  In Week 12, participants will have a study visit with heart and lung function tests.~          They will also have a 6-minute walk test, and provide blood and urine samples.~        -  After additional study visits for blood samples, participants will have a final visit in~          Week 24. The tests from Week 12 will be repeated at this visit.~   "
141695|NCT01712607|"~     Background and Objectives: All modern surgical procedures require a high level of cognitive~     and psychomotor skills achieved using different training methods, but could be influenced by~     fatigue and other psychological factors. We evaluate the effect of warm-up exercises on~     operative laparoscopic performances in gynecologic laparoscopic procedures.~      Methods: The surgical team operates on a consecutive series of 20 patients and perform~     laparoscopic salpingo-oophorectomy. Patients are randomly allocated in 2 groups: group A to~     be operated on without warm-up exercises and group B to be operated on after a short-term~     warm-up. All patients are operated on by the same surgical team. The full-time records of the~     operation were analyzed by 2 independent reviewers. Laparoscopic procedures are recorded and~     assessed by 2 independent observers using the generic OSATS rating scale. A training module~     using the Lap Sim simulator was designed for the warm-up.~   "
141696|NCT01712594|"~     Currently, patients diagnosed with type 1 diabetes rely on either finger stick or sensor~     glucose readings when making their insulin dosage decisions. Designing a computerized system~     that mimics the way insulin is produced naturally in a person who does not have type 1~     diabetes holds many challenges; all of which cannot be addressed in just one study. The~     purpose of the Medtronic Overnight Closed Loop study is to assess the performance of a system~     designed to automatically infuse the correct insulin dose during the hours that the patient~     is sleeping.~      The system consists of an insulin pump that provides insulin to the patient through an~     infusion set. A sensor inserted just under the patient's skin measures glucose levels and a~     transmitter sends this information to the pump. To enable the sensor to register the glucose~     information correctly, it must be set (calibrated) by a finger stick blood glucose 3-4 times~     a day. In the commercially released system, the physician would recommend the continuous~     background (basal) insulin rates and the patient would be required to make decisions~     regarding extra insulin (bolus) for meals or as a response to high glucose levels.~      In the Closed Loop System, a mobile control system is added to these devices. This consists~     of an Android phone, a closed loop algorithm and a translator. This system is designed to~     translate the sensor information and direct the pump to provide the required dosage of~     insulin automatically without requiring input from the patient.~      Reliable calibration has proved challenging, and so it is important that the system function~     safely, even when calibration is inaccurate. In this study, a calibration error will be~     introduced under very controlled circumstances. This testing will identify if the system can~     maintain acceptable overnight glucose levels, regardless of whether or not calibration is~     ideal.~   "
141697|NCT01712581|"~     T1, T2 and T2* relaxation times, as determined with cardiac MRI, are markers of myocardial~     tissue content (water, fibrosis, iron).~      The aim of study is to determine the normal values of T1, T2 and T2* relaxation times in~     healthy volunters aged 18-69 years using 1.5T clinical MRI.~   "
141698|NCT01712568|"~     Study subjects were screened and enrolled for the study. Subjects were housed in the clinical~     facility from not less than 12 hours pre-dose till at least 24 hours post-dose in each~     period. After maintaining at least 10 hours of overnight fast Test or Reference product was~     administered orally (as per the randomization schedule) to each subject with about 240 mL of~     water at ambient temperature in each period by trained study personnel.~      The pre-dose (0.00 hours) blood sample was collected before dosing and post-dose samples were~     collected at 2.00, 3.00, 4.00, 5.00, 5.50, 6.00, 6.50, 7.00, 7.50, 8.00, 8.50, 9.00, 9.50,~     10.00, 10.50, 11.00, 12.00, 14.00, 16.00, 20.00, 24.00 and 30.00 hours in each study period~     with a washout period of 7 days between the dosing of two periods. Subjects were continuously~     monitored for well being i.e., blood pressure, radial pulse and oral temperature before~     check-in, prior to drug administration and at regular intervals post dose in each period. The~     concentration of Ropinirole in plasma samples obtained from study subjects was determined~     using validated LC-MS/MS method. Pharmacokinetic and statistical analyses were performed on~     obtained drug concentration data, using appropriate software.~   "
141699|NCT01712555|"~     After people lose an eye, for whatever reason, they often experience fat atrophy of the~     tissues in the orbit. This leads to a sunken appearance that is often not correctable by a~     cosmetic shell prosthesis. Current techniques to correct this deformity are inadequate/~     invasive. Injection of various gels (Restylane, Radiesse) are temporary had have their own~     disadvantages. This study seeks to demonstrate an improvement in the retention of injected~     autologous fat by mixing in autologous PRP (platelet rich plasma).~   "
141700|NCT01712542|"~     Measuring the bioavailability of orally administered curcumin in the tumors of glioblastoma~     patients.~   "
141701|NCT01712529|"~     The purpose of this study is to evaluate the effect of supervised physical exercise on~     endothelial function and number of endothelial progenitor cells (EPCs) in patients with~     systemic lupus erythematosus, as well as evaluate the effect of supervised physical exercise~     on endothelium derived growth factor (VEGF) levels, disease activity, quality of life,~     fatigue, perceived exertion and cardiopulmonary exercise test variables.~   "
141702|NCT01712516|"~     This study will assess the efficacy, safety and tolerability of indacaterol~     maleate/glycopyrronium bromide in patients with moderate to severe airflow limitation.~   "
141735|NCT01712087|"~     This post-approval study will primarily evaluate the long-term safety of the MedStream~     Programmable Infusion System when used in combination with Baclofen for the treatment of~     severe spasticity. A secondary objective, to assess long-term effectiveness, based on the~     observed scores on the Ashworth Scale (rigidity for the lower extremities) and their Spasm~     Scores over the 36-month follow-up period will also be described.~   "
141703|NCT01712503|"~     This is a randomised controlled trial that formally compares intra-ocular lenses, which can~     be used in cataract surgery, one of which is the standard 'monofocal' lens, and the other is~     the newer toric lens which can correct astgimatism.~      The null hypothesis is that both intra-ocular lenses give the same visual outcome in cataract~     surgery. The alternative hypothesis is that the toric lens, provides a better unaided~     (without glasses) vision, by correcting the participant's astigmatism.~      It has been decided to conduct a randomised controlled trial of the two lenses, as although~     the toric lenses are endorsed by many case series (which show a reduction in astigmatism),~     they have not been formally compared to the standard lens. An RCT will enable the formal~     comparison.~      It is expected that this trial will take approximately a year to conduct: six months of~     recruitment and six months of follow-up. A further six months will be required to analyse the~     data and prepare a manuscript for publication.~      The investigators do not plan to conduct an interim analysis or report as this is a~     short-trial (six months follow-up) using two alternative lens that are CE marked and already~     widely used.~      Participants who have both cataract and astigmatism will be identified from the~     GP/optometrist referral letter. They will be seen in specially designated clinics for this~     research study, which will run alongside the routine cataract 'one' stop clinics at St~     Richard's Hospital and Worthing Hospital. This will allow for those patients who wish to be~     part of the study to have all the necessary examination done in one visit and for those who~     decline participation to be seen in the regular cataract clinic. Potential participants will~     be sent the research trial information (appendix A) with their appointment letter.~      After introducing himself the researcher (who is also a senior cataract surgeon at Western~     Sussex Hospital Trust), will check if potential participants have had the opportunity to read~     the trial information that they were sent, or give participants a further copy as required.~     The key points of the trial will be re-iterated by the researcher and they will be invited to~     ask any questions about the trialThe researcher will check that the potential participant has~     read and understood the participant information leaflet. They will answer any questions that~     the potential participant has and will then take signed consent from those willing to~     participate.~      Only one eye (the 'trial eye') from each patient will be used in the trial. In patients with~     bilateral cataract, one eye will be selected as the trial eye. This will be the eye that the~     participant prefers, after consultation with the researcher or surgeon, to have operated~     first. The participant will be allocated a unique study reference number.~      Patients who decline to take part in the trial will be offered cataract surgery as per usual~     WSHT/NHS procedure.~   "
141704|NCT01712490|"~     This open-label, randomized, 2-arm, multicenter, phase 3 study has the primary objective of~     comparing the modified progression-free survival (mPFS) obtained with brentuximab vedotin~     (ADCETRIS®) plus AVD (doxorubicin [Adriamycin], vinblastine, and dacarbazine; abbreviated~     A+AVD) versus that obtained with ABVD (doxorubicin [Adriamycin],bleomycin, vinblastine, and~     dacarbazine) for the frontline treatment of advanced classical Hodgkin lymphoma(HL)~   "
141705|NCT01712477|"~     This is a prospective randomized controlled pilot study in traumatic brain injury (TBI)~     patients who are sedated with either propofol or midazolam to compare the cytokine response~     and neuropsychological outcomes with and without elevated blood alcohol levels.~      Sedation is part of the standard treatment in patients with a TBI and has been proposed as a~     neuroprotective intervention in head-injured patients. Sedative regimens, such as midazolam~     and propofol, are not standardized and it is unclear whether sedation has a significant~     impact on recovery and outcome. A review of propofol versus midazolam in mechanically~     ventilated patients shows evidence that both provide effective sedation but there is lack of~     data to support one sedative over the other.~      Cytokines are released in response to tissue injury and act to generate a variety of~     physiologic responses. The cytokine elevation has been correlated with the extent of tissue~     injury. This study will compare the cytokine distribution patterns at specific posttraumatic~     time points in patients with a TBI sedated with either propofol or midazolam. Additional~     analysis will compare the cytokine response in patients whom had elevated blood alcohol~     levels with those with normal levels. Neuropsychological testing will also be performed to~     determine the extent of brain injury and recovery.~   "
141706|NCT01712464|"~     This study aims to examine the modulation of neuronal and behavioural parameters of social~     reinforcement learning.~   "
141707|NCT01712451|"~     Dose ranging study~   "
141708|NCT01712438|"~     Investigate the inhibitor development rate of Human cl rhFVIII in previously untreated~     patients with severe Hemophilia A.~   "
141709|NCT01712425|"~     The HIVconsv gene was constructed by assembling the 14 most conserved regions of the HIV-1~     proteome into one chimaeric protein. This gene has been inserted into 2 leading~     non-replicating vaccine vectors: an attenuated chimpanzee adenovirus serotype 63 (ChAdV63)~     and a modified vaccinia virus Ankara (MVA) to construct the ChAdV63.HIVconsv and MVA.HIVconsv~     HIV-1 candidate vaccines. The present study is named ChAd-MVA.HIVconsv-BCN01 and it is a~     phase I, multicenter primary/booster therapeutic vaccination study to evaluate the safety and~     immunogenicity of ChAdV63.HIVcons and MVA.HIVconsv HIV-1 vaccines, delivered intramuscularly~     according to a 0-8 weeks or a 0-24 weeks schedule to recently HIV-1 infected individuals with~     early viral suppression 6 months after initiation of Tenofovir/Emtricitabine plus~     Raltegravir.~   "
141710|NCT01712412|"~     The objectives of this study are to determine the safety and efficacy of IW-9179 administered~     to patients with functional dyspepsia (FD).~   "
141711|NCT01712399|"~     A clinical study to investigate the safety of mavrilimumab, an antibody being developed for~     the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that~     affects the joints.~   "
141712|NCT01712386|"~     Patients with moderate chronic obstructive pulmonary disease (COPD) typically have reduced~     exercise capacity. This is because their lungs are damaged and because of increased work of~     breathing. In some patients, exercise capacity is reduced to such a level that even simple~     activities of daily living, such as washing and dressing, may impose a challenge.~      Recent findings in healthy young people suggest that increasing the amount of nitrate in our~     diet in the form of beetroot juice can improve the ability to exercise. Studies involving~     cycling have shown that less oxygen is needed to perform the same level of exercise after~     taking more nitrate in the diet. Nitrate (found in abundance in beetroot) is known to be~     converted in the body to nitric oxide (NO), a substance which increases blood flow and may~     affect the energy-producing mechanisms inside muscle cells. A recent exciting finding is that~     such dietary nitrate supplementation appears to reduce the amount of oxygen needed to~     complete moderate intensity exercise (walking) in healthy individuals. It is the purpose of~     this study to see if such effects could be seen in COPD patients. If this is indeed the case,~     then it may suggest that a period of dietary supplementation of a relatively cheap, widely~     available, and natural food product may improve the ability of patients to undergo everyday~     tasks and ultimately improve their quality of life.~      To help investigators understand the effects of dietary nitrate supplementation on the~     ability to exercise in COPD patients, the investigators will recruit 15 people with mild to~     moderate disease. They will complete a series of undemanding exercise tests on three separate~     occasions. On one occasion they will have had a course of nitrate rich beetroot juice leading~     up to the tests, and on the other occasion they will have had a course of beetroot juice with~     the nitrate removed. The investigators will monitor blood pressure, levels of nitrate and~     nitrite in the blood, oxygen uptake and functional capacity during the tests which will allow~     us to assess any effects that may have occurred as a result of increased nitrate intake.~   "
141713|NCT01712373|"~     The purpose of this study was to evaluate the efficacy and safety of Ginseng in treatment of~     fatigue and Quality of Life of MS patients.~   "
141714|NCT01712360|"~     This study is being done to see how the body is affected when a study drug is applied to both~     feet if the subject has athlete's foot or to both feet and the groin area if the subject has~     both athlete's foot and jock itch. Safety of the drug and how well the drug works will also~     be measured.~   "
141809|NCT01711125|"~     To explore the effectiveness and biobehavioural basis of baclofen in improving treatment~     outcomes for alcohol dependence in people with or without alcoholic cirrhosis in a~     double-blind randomised placebo-controlled trial.~   "
141719|NCT01712295|"~     Plantar warts on the sole of the foot are among the most common warts seen in podiatry~     clinics. Some patients are readily cured by simple standard of care treatments that include~     wart debridement (trimming or excision) and application of 17% salicylate (commercially known~     as Compound W)or by other treatments that may be painful and affect mobility. No treatment is~     consistently effective and most patients fail treatment multiple times.~      Ethyl pyruvate (EP)is a common food additive noted to be 'generally regarded as safe' that~     may improve the activity of salicylate in wart treatment by improving the ability to~     penetrate and/or persist in the skin. The use of 17% salicylate with the addition of EP may~     improve cures of common foot plantar warts in subjects who also be receiving other~     standard-of-care treatment.~   "
141720|NCT01712282|"~     Stroke is the leading cause of adult disability in Europe and United States and the second~     leading cause of death worldwide and affects more than 10,000 Danes each year.~      Studies in a late and stationary phase after stroke have shown that physical rehabilitation~     is of great importance for survival and physical ability of these patients, however many~     studies show that patients lie or sit next to their bed under hospitalization for more than~     88.5 % of the daily hours. Physical activity in stroke patients has never previously been~     measured immediately after debut of symptoms; furthermore there is no knowledge about the~     optimal dose of physical rehabilitation for these patients.~      Accelerometers, small measuring devices, are a relatively new way to measure physical~     activity precisely, and hence it is possible to obtain an objective measure of how active~     stroke patients are in the first week after admission. The accelerometers measure a variable~     voltage, depending on the range and intensity of movement. They can measure movement~     dependent of the placement of the accelerometer, for instance over the hip, arm or leg.~     Studies confirm their reliability, even in patients with abnormal gait, such as stroke~     patients.~      Another approach of studying the effects of physical activity and rehabilitation is through~     the examination of biomarkers. Studies have shown that biomarkers released during physical~     activity can inhibit biomarkers released after tissue injury in the brain, as seen after~     stroke. These brain biomarkers cause further damage and studies show that the higher the~     levels, the higher the damage. It is therefore obvious to examine whether physical activity~     rehabilitation can down regulate this destructive process in patients with stroke.~      Clarification of the optimal dose of physical activity in stroke patients immediately after~     debut of symptoms and examination of both the biochemical aspects of physical rehabilitation~     as well as the optimal dose of physical rehabilitation is of great importance for many~     patients, their relatives as well as of a great socioeconomic importance.~      The purpose of the project is to investigate feasibility of treadmill training on a~     weight-bearing treadmill in the acute phase after admission after an ischemic stroke.~     Furthermore we wish to investigate the acute inflammatory response after ischemic stroke and~     whether it changes with treadmill training.~   "
141721|NCT01712269|"~     The central aim of this research project is to determine how the ever-growing problem of~     obesity in the western world contributes to the pathophysiology of obstructive sleep apnea~     (OSA). To complete this aim, the investigators will determine the impact of obesity on the~     mechanisms underlying OSA. This will be achieved by making physiological measurements of 4~     physiological traits known to cause OSA as well as the patients sleep apnea severity, before~     and after weight-loss surgery (i.e. bariatric surgery).~   "
141722|NCT01712256|"~     During the course of HIV infection the number of CD4 cells decreases, resulting in a reduced~     immunological response and eventually immune deficiency. Vacc-4x is a peptide-based HIV~     immunotherapy vaccine and is anticipated to strengthen the immune system's response to HIV.~      All patients participating in this trial have previously received the vacc-4x vaccine in~     order to reduce the amount of HIV-1 virus in the blood and increase the immune response. The~     primary objective of this study is to evaluate if a re-boost with Vacc-4x could further~     reduce the amount of HIV-1 virus and increase the immune response.~   "
141723|NCT01712243|"~     The purpose of this study is to determine whether specific wavelengths of light at night can~     be used to improve mobile balance while simultaneously not increasing alertness.~   "
141724|NCT01712230|"~     This study is designed to determine whether a reduction in hormones (such as occurs during~     menopause) causes a decrease in calories burned during physical activity. This study will~     also determine whether a reduction in hormones decreases calories burned while sleeping,~     resting, and eating and whether an exercise intervention can prevent this.~   "
141725|NCT01712217|"~     The purpose of the study is to evaluate safety and efficacy of AT13387 Alone and in~     Combination with Crizotinib in the Treatment of Non-small Cell Lung Cancer.~   "
141726|NCT01712204|"~     Initiation of ULT for gout increases the occurrence of acute gouty arthritis flares due to~     mobilization of urate from tissue deposits. IL-1β plays a key role in mediating the~     inflammatory response in gouty arthritis. The efficacy of IL-1β blockade in the prophylaxis~     of gouty flares during initiation of ULT has been validated in multiple trials of IL-1β~     inhibitor therapies. Therefore, it is believed that IL-1β is a relevant therapeutic target~     for gout flares. AC-201 is an IL-1β modulator indicated for the treatment of osteoarthritis~     with good safety record and very few contraindications to the co-morbidities commonly among~     gout patients. AC-201 has also been demonstrated to have uric acid-lowering effects in~     clinical trials. The favorable product profile of AC-201 overall provides a strong rationale~     for investigating its clinical utility as prophylaxis against flares when initiating ULT.~   "
141727|NCT01712191|"~     This is a prospective, multi-center, open label, non-randomized study, evaluating the~     treating of medial meniscus deficiency with the NUsurface Meniscus Implant.~   "
141728|NCT01712178|"~     A study in Rheumatoid Arthritis (RA) patients to evaluate two formulations of adalimumab for~     pharmacodynamics, pharmacokinetics, and safety.~   "
141729|NCT01712165|"~     The purpose of this study is to determine if consuming ANMUM Materna (a fortified milk~     product) over a 12-week period increases red blood cell folate concentrations in women of~     childbearing age in Singapore, compared to an equivalent amount of standard (unfortified)~     milk.~   "
141730|NCT01712152|"~     Carriers of Duchenne muscular dystrophy (DMD) often have no severe symptoms of the scelet~     muscles, but they may develop a poor heart function due to the involvement of the heart~     muscle. Ultrasound of the heart is recommended, but it can detect a cardiac affection only~     after the heart has already become weaker. Cardiac magnetic resonance tomography can detect~     myocardial fibrosis already at preserved heart function and may facilitate early therapy. In~     our study, diagnosed carriers of DMD will undergo examinations of the heart by blood tests,~     EKG, heart ultrasound and magnetic resonance at enrollment and after one year in order to~     assess the extent of cardiac affection and its association with the clinical development.~   "
141731|NCT01712139|"~     The objective of this study was to prove the bioequivalence of Roxane Laboratories'~     Irbesartan and Hydrochlorothiazide 300 mg / 25 mg Tablets under fasted conditions.~   "
141732|NCT01712126|"~     The objective of this study was to prove the bioequivalence of Roxane Laboratories'~     Irbesartan and Hydrochlorothiazide 300 mg / 25 mg Tablets under fed conditions~   "
141733|NCT01712113|"~     The objective of this study was to prove the bioequivalence of Roxane Laboratories'~     Irbesartan 300 mg Tablets under fasted conditions~   "
141734|NCT01712100|"~     The objective of this study was to prove the bioequivalence of Roxane Laboratories'~     Irbesartan 300 mg Tablets under fed conditions.~   "
141736|NCT01712074|"~     This study will evaluate safety and efficacy of PF-05212377 in subjects with mild-to-moderate~     Alzheimer's Disease with existing neuropsychiatric symptoms on a stable dose of Donepezil.~     The 4-week run-in will minimize placebo effect. The 12-week treatment period is considered~     the minimum length necessary to reliably evaluate the effect PF-05212377 on cognition and and~     neuropsychiatric symptoms in this population. The 2-week washout will allow to monitor~     re-emergence of neuropsychiatric and cognitive symptoms.~   "
141737|NCT01712061|"~     The study hypothesis under test is that administration of a CCR2/5 antagonist to subjects~     with type 2 diabetes and overt nephropathy will result in a reduction in urinary albumin, a~     surrogate for improved glomerular filtration.~   "
141738|NCT01712048|"~     The aim of this study is to compare the efficacy and safety of two standard methods of~     polypectomy (polyp removal), submucosal injection-assisted endoscopic mucosal resection (EMR)~     and full water emersion (without submucosal injection) EMR, for large colorectal polyps.~   "
141739|NCT01712035|"~     Age-related macular degeneration (AMD) is the leading cause of blindness in non-Hispanic~     white Americans. Neovascular AMD is an advanced form of macular degeneration that~     historically has accounted for the majority of vision loss related to AMD. The presence of~     choroidal neovascular membrane (CNV) formation is the hallmark feature of neovascular AMD.~     Choroidal neovascular membranes consist of buds of neovascular tissue and accompanying~     fibroblasts from the choroid perforating Bruch's membrane with extension either above or~     below the retinal pigment epithelium. These neovascular complexes are associated with~     hemorrhage, fluid exudation and fibrosis formation resulting in photoreceptor damage and~     vision loss. Treatment of neovascular AMD consists of injecting inhibitors of vascular~     endothelial growth factor (VEGF) into the vitreous cavity to interfere with proliferation of~     choroidal neovascularization and to reduce vascular permeability.~      OCT is an imaging technology that can perform non-contact cross-sectional imaging of retinal~     and choroidal tissue structure in real time. It is analogous to ultrasound B-mode imaging,~     except that OCT measures the intensity of reflected light rather than acoustical waves.~      This observational study will use OCT technology to study and compare the retinal and~     choroidal anatomy and blood flow in two groups of patients with neovascular AMD: treatment~     naïve group and active treatment group.~      The purpose of this study is to assess the utility of OCT angiography in the evaluation of~     NVAMD.~   "
141740|NCT01712022|"~     Optovue has developed a new feature for mapping corneal epithelial thickness. The purpose of~     the study is to evaluate the accuracy and repeatability of the epithelial thickness~     measurement. Consented subjects will undergo a series of cornea measurements using optical~     coherence tomography (OCT) that will be used for analysis.~   "
141741|NCT01712009|"~     The primary objective of the study is to estimate the difference in bone pain between breast~     cancer patients receiving chemotherapy and pegfilgrastim and either no prophylactic~     intervention, prophylactic naproxen, or prophylactic loratadine.~   "
141742|NCT01711996|"~     Urinary Neutrophil gelatinase associated lipocalin (NGAL) has been recently reported to be~     related with the degree of hydronephrosis in pediatric ureteropelvic junction obstruction~     (UPJO) patients. We are trying to analyze whether it is related with the grade of renal~     injury in UPJO patients.~   "
141743|NCT01711983|"~     The primary objective of the GORE® Septal Occluder Study is to evaluate the safety and~     efficacy of the occluder device in the treatment of transcatheter closure of ostium secundum~     atrial septal defects (ASDs). The data obtained in this study will evaluate this next~     generation device as compared to outcomes of prior studies conducted with the GORE® HELEX®~     Septal Occluder.~   "
141744|NCT01711970|"~     This is a prospective, open label, dose escalating, Phase I/II study, measuring mainly the~     safety and tolerability of the combination of intravenous administration of VB-111 and~     paclitaxel in patients with platinum resistant ovarian cancer.~   "
141745|NCT01711957|"~     Recent experimental and clinical studies have shown that platelets play a critical role in~     liver ischemia and regeneration. Thrombocytopenia, a frequent and potentially serious~     condition in liver transplantation (LT) recipients, was shown to be associated with~     postoperative morbidity and mortality after partial hepatectomy.~      The investigators aim at evaluating whether postoperative low platelet counts are indicators~     of short- and long-term outcomes after liver transplantation.~   "
141746|NCT01711944|"~     Parents of children newly diagnosed with cancer experience depression and anxiety, especially~     in the first several months of treatment. Bright IDEAS, an 8-session problem-solving skills~     training (PSST) program has been used in studies with more than 900 mothers including more~     than 125 monolingual Spanish-speaking mothers. It has been shown to significantly decrease~     mothers' distress and to particularly benefit Latina immigrants. This past spring, the~     NCI/NIH designated Bright IDEAS as a Research-Tested Intervention Program and has included it~     in the National Registry of Evidence-based Programs and Practices. To date, Bright IDEAS has~     been available to mothers at only a few cancer centers with specially trained personnel. This~     proposal is designed to bring Bright IDEAS on-line to make it available to mothers and~     fathers 24/7 anywhere with Internet access. The investigators will carefully analyze~     acceptability and use to gain insight into the most promising ways of disseminating~     interventions like Bright IDEAS using Internet, Internet II, and other emerging technologies.~   "
141747|NCT01711931|"~     The purpose of this study is to compare the efficacy and safety of everolimus- and~     biolimus-bluting stents with everolimus-eluting bioresorbable vascular scaffold stents.~      The null hypothesis to be rejected is that there is no significant difference with regard to~     lumen late loss at 9 months and a clinical end point of death, myocardial infarction and TVR~     at 12 months between everolimus-eluting and biolimus-eluting stents and everolimus-eluting~     bioresorbable vascular scaffold stents.~   "
141748|NCT01711918|"~     To provide oral domperidone to patients between the ages of 18 and 60 years of age, according~     to the investigator's judgment, a prokinetic effect is needed for the relief of severe~     gastroparesis. We have defined severe gastroparesis as 1) positive gastric emptying~     scintigraphy (more than 10% residue at 4 hours), 2) nausea, 3) early satiety, 4) abdominal~     pain. We will recruit patients for two years and the patients will be given domperidone for~     up to two years.~   "
141749|NCT01711905|"~     The aim of this study is to investigate whether a supplementation of 20 µg Vitamin D3 per day~     for 12 weeks can be used to normalize vitamin d-Status~   "
141750|NCT01711892|"~     Androgen Deprivation Therapy (ADT) is standard treatment for locally advanced or advanced~     Prostate Cancer (PC).~      The musculoskeletal toxicity associated with ADT is well established, leading to a decrease~     in muscle mass, increased fat percentage, weight gain, sexual dysfunction and increased risk~     of depression, fatigue, diabetes, cardiovascular disease and reduced quality of life.~      Numerous studies have shown an association between physical activity, physical capacity and~     quality of life in cancer patients and recent epidemiological research suggest that regular,~     moderate-intensity physical activity may have a positive effect on survival in men with~     prostate cancer.~      Within exercise physiology there is new evidence pointing to recreational soccer as a unique~     form of intermittent exercise that effectively stimulates aerobic and anaerobic energy~     delivery systems, leading to beneficial musculoskeletal, metabolic and cardiovascular~     adaptations of importance for health.~      It is our overall hypothesis that 12 weeks of recreational soccer training 2-3 times per week~     will improve the health profile of PC patients receiving ADT treatment.~   "
141751|NCT01711879|"~     This 52 week study will assess the use of intravitreal aflibercept injections in patients~     with neovascular glaucoma (NVG) compared to standard of care panretinal photocoagulation.~      The investigators hypothesize that the neovascularization of the iris and angle present in~     neovascular glaucoma will resolve more quickly in eye treated with intravitreal aflibercept~     injection alone and result in increased comfort and preservation of visual field as compared~     to current standard of care utilizing pan-retinal photocoagulation. The advantages to~     intravitreal aflibercept injection use could include resolution of NVI/NVA~     (neovascularization of the iris/neovascularization of the angle) leading to quicker pain~     relief and quicker lowering of IOP (intraocular pressure).~   "
141752|NCT01711866|"~     The purpose of this study is to assess the safety and feasibility of switching subjects with~     advanced Parkinson's Disease (PD) from Pramipexole or Ropinirole to Rotigotine and to assess~     the effects of Rotigotine on motor and non-motor symptoms of Parkinson's Disease in subjects~     switched from previous treatment with either Pramipexole or Ropinirole.~   "
141753|NCT01711853|"~     The study to be conducted is a prospective, open label trial. It is designed to evaluate the~     pharmacokinetic/pharmacodynamic and coagulation parameters and safety of dabigatran etexilate~     in patients with chronic kidney disease.~   "
141754|NCT01711840|"~     The purpose of the investigation is to confirm the safety of patients receiving Symbicort~     Turbuhaler as maintenance and reliever therapy ( Symbicort SMART) under the post-marketing~     actual use.~   "
141755|NCT01711827|"~     The purpose of this study is to assess the effect of multiple doses of isavuconazole on the~     pharmacokinetics of prednisolone after single dose administration of prednisone. This study~     will also assess the safety and tolerability of isavuconazole alone and in combination with~     prednisone.~   "
141756|NCT01711814|"~     The purpose of this study is to evaluate the long-term safety and efficacy of ASP015K in~     subjects with Rheumatoid Arthritis (RA) who have completed a preceding Phase 2 ASP015K RA~     study.~   "
141757|NCT01711801|"~     This randomized, Investigator/Subject-blind, adaptive single-ascending-dose,~     placebo-controlled, parallel study will evaluate the safety, tolerability, pharmacokinetics~     (including the effect of food), and pharmacodynamics of RO5545965 following oral~     administration in healthy male volunteers. In Part 1, subjects will be randomized in cohorts~     to receive single ascending doses of RO5545965 or placebo. In Part 2, subjects will receive 2~     doses of RO5545965, in the fed or fasted state, in randomized sequence with a washout period~     of approximately 2 weeks between treatment periods.~   "
141758|NCT01711788|"~     The purpose of this study is to determine if the method of intrabone infusion of hematologic~     stem cells can increase and accelerate hematopoietic reconstitution after umbilical cord~     blood transplantation in pediatric patients.~   "
141759|NCT01711775|"~     This single-center, non-randomized, open-label study will assess the pharmacokinetics of~     aleglitazar after administration of single and multiple oral doses in healthy Chinese~     volunteers. Subjects will receive a single oral dose of aleglitazar on Day 1 and repeated~     oral doses once daily from Day 5 to Day 14. Anticipated time on study, including screening~     and a 2-week follow-up, is up to 8 weeks.~   "
141760|NCT01711762|"~     This open-label, non-randomized study will assess the absorption, metabolism, and excretion~     of radioactive-labeled [14C]-GDC-0973 in healthy male volunteers. Volunteers will receive a~     single dose of [14C]-GDC-0973.~   "
141761|NCT01711749|"~     This is an open-label, randomized, two treatment, two sequences, two periods crossover study,~     using a crossover 2x2 design, where each subject will be randomly assigned to reference or~     test formulation, in order to evaluate if both formulations are bioequivalent.~   "
141762|NCT01711736|"~     The purpose of this study is to investigate the immunogenicity, reactogenicity and safety of~     the new influenza vaccine GSK2282512A (FLU-Q-QIV) and compare its activity to the marketed~     vaccine Fluarix® (TIV) in young children 6 to 35 months of age.~   "
141763|NCT01711723|"~     In accordance with the recently revised FDA draft renal impairment guidance (March 2010)~     which advises the conduct of renal impairment study in drugs that are not predominately~     eliminated through the renal route, the proposed study will be conducted to formally assess~     the pharmacokinetics (PK) of darapladib in severely renally impaired subjects.~      In this is an open-label, non-randomized study eight subjects with severe renal impairment~     will be recruited along with 8 healthy control subjects matched to the severe renal~     impairment subjects based on gender, body mass index (plus or minus 20%) and age (plus or~     minus 10 years).~      All subjects will receive repeat oral doses of darapladib 160 milligram (mg) for 10~     consecutive days. The pharmacokinetics of darapladib and its metabolites; and safety and~     tolerability will be evaluated.~      All the subjects will be admitted to the clinic on the evening of Day -1. Subjects may check~     out of the clinic on Day 2 after all assessments are complete, but must return to the clinic~     each day (Days 3-8) for dosing and assessments. Subjects will be admitted to the clinic again~     on the evening of Day 9. After the last dose of the study drug, there will be a follow-up~     period which will include 2 visits (Day 20-24 and Day 38-52). The total study duration for~     each subject including the screening, treatment and follow-up periods will be approximately~     11 weeks.~   "
141764|NCT01711710|"~     The aim of this study is to evaluate the safety and efficacy of Cohesive Silicone Gel-Filled~     Breast Implant (CoSBI) produced by HansBiomed co.,Ltd. in breast reconstruction or~     augmentation~   "
141765|NCT01711697|"~     This phase I trial studies the best dose of radiation therapy in treating patients with~     locally advanced non-small cell lung cancer that cannot be removed by surgery. Radiation~     therapy uses high energy x rays to kill tumor cells. Specialized radiation therapy, such as~     stereotactic body radiation therapy (SBRT), that delivers a high dose of radiation directly~     to the tumor may kill more tumor cells and cause less damage to normal tissue. SBRT has been~     shown to provide excellent results when used in early stage lung cancer, but has not yet been~     applied to patients with more advanced disease.~   "
141766|NCT01711684|"~     Melanoma is a life-threatening cancer which poses a significant health burden, especially~     when metastatic or spreading to areas other than the original tumor growth. Although various~     treatment options are currently available for melanoma, melanomas that have metastasized~     widely to the skin pose a significant clinical challenge as the available therapies have~     limited effect. This study proposes the use of a topically applied compound named~     diphenylcyclopropenone (DPCP) which has been shown to be effective in treating melanoma~     patients whose diseases have spread widely throughout the skin. DPCP works by having a~     patient's own immune system, which is usually used to fight infections, attack cancerous~     cells. This compound has commonly been used to treat other conditions such as warts and hair~     loss throughout the world for many years and is known to cause limited side effects. Altering~     a patient's own immune system through topical treatments has also been shown to benefit~     patients with other cancers that have metastasized to skin such as breast cancer. In this~     study, the investigators will use DPCP to treat cutaneous metastases of various cancers~     including melanoma. Our overall intention is to get a better understanding of effective~     immune responses in the skin that may mediate metastatic cancer regression or cure.~   "
141767|NCT01711671|"~     A study to evaluate the safety, efficacy and bone changes with combination therapy of~     intravenous (IV) infused DKN-01 and lenalidomide/dexamethasone, versus lenalidomide and~     dexamethasone in relapsed or refractory multiple myeloma (MM) patients~   "
141768|NCT01711658|"~     PURPOSE: This trial is studying if and how well lapatinib adds to the effectiveness of~     radiation therapy plus cisplatin in patients who have head and neck cancer that is not~     related to the HPV virus.~   "
141769|NCT01711645|"~     Monitoring immune response and longevity in serum and milk after Tdap administration to~     postpartum women. The clinical trial will involve women (aged 18 - 45 years) who have just~     delivered full-term infants (greater than or equal to 37 completed weeks of gestation) at~     Vanderbilt University Medical Center. The enrollment period will be fifteen months. The~     duration is over two years of observation.~   "
141770|NCT01711632|"~     The purpose of this study is to find out what effects, good and/or bad, treatment with~     vemurafenib (also known as Zelboraf™) has on the patient and on leukemia. Specifically, the~     researchers want to know how well vemurafenib eliminates leukemia from the blood.~   "
141771|NCT01711619|"~     The purpose of this study is to compare the effectiveness of peripheral nerve stimulation~     utilizing a subcutaneous lead implant technique (SQS) plus optimized medical management (OMM)~     versus OMM alone in patients suffering from back pain due to Failed Back Surgery Syndrome~     (FBSS).~   "
141772|NCT01711606|"~     This prospective observational study (registry) on Fragile X syndrome (FXS) is designed to~     evaluate characteristics, management and patient and caregiver-related outcomes the quality~     of life of Families and patients with FXS and to collect epidemiological and health economic~     data.~        -  EXPLAIN will report current and comprehensive data onEpidemiology data on fragile X~          syndrome~        -  Characterisation of the phenotype of FXS patients~        -  Description of patient characteristics (demographics, family history, comorbidity,~          education, working situations, care situations, insurance status)~        -  Documentation of therapeutic interventions~        -  Recording and assessment of psychosocial parameters (possibly also inclusion of family~          members, carers)~        -  quality of life of the carer and if possible the patient~        -  Health economic parameters and consumption of resources~   "
141773|NCT01711593|"~     Despite advances in medications, allergic diseases, including allergic asthma continue to~     rise in prevalence. For this reason, there is a need for a better understanding of the~     mechanisms of allergic diseases and novel insights into modulating allergic inflammation. The~     investigators hypothesize that much remains to be learned about the behavior of T effector~     and T regulatory cells in allergic disease. Furthermore, the investigators hypothesize that~     novel mechanisms of allergic tolerance may exist, and elucidation of these mechanisms may~     provide insights into novel therapeutic strategies to control allergic diseases. The~     investigators will investigate the capacity for T cell tolerance induction in allergic~     subjects by a novel type of immune tolerizing dendritic cell (it-DC). The investigators will~     assess whether in vitro generated it-DCs have the capacity to induce antigen-specific T~     regulatory cells and suppress allergen-specific T effector cell function in vitro.~      Standardized Cat Allergen extract and Dust Mite Allergens will be used to generate changes in~     the airways that occur during exposure to allergen. For this investigation, the route of~     administration will be topical application of the titrated allergen to a bronchoscopically~     isolated subsegment of one lobe of one lung. The dose of biologic will be determined from~     prior skin-prick testing.~   "
141774|NCT01711580|"~     Patients with a high grade glioma have an increasing overall survival and progression free~     survival after initial treatment. Because of a better performance status these patients are~     more often eligible for re-treatment with for example radiotherapy. However, to date only a~     few prospective studies on re-irradiation of gliomas exist and very little is known about the~     effects of re-irradiation on quality of life and cognition. This trial is designed to~     longitudinally establish the effects of re-irradiation on quality of life, cognition and~     physical performance in patients with a high grade glioma. Based on the currently available~     information the investigators hypothesize that quality of life after re-irradiation can be~     kept stable until further tumour progression.~   "
141810|NCT01711112|"~     Based on the previous clinical experience in other cancers, and considering the absence of~     current standard salvage regimens, the single agent docetaxel is selected as the regimen for~     this phase II study. Main toxicity of docetaxel is myelosuppression. The low rate of severe~     myelosuppression observed in other cancer trials warrants further study in urothelial cancer.~     The objective of the study is to evaluate the safety and activity of weekly docetaxel given~     as salvage therapy for advanced urothelial cancer.~   "
141775|NCT01711567|"~     Entecavir, a potent antiviral agent, has been widely used for treatment-naïve chronic~     hepatitis B patients. However, about 20% of patients showed partial virologic response after~     2 year of entecavir therapy (33% in HBeAg positive, 10% in HBeAg negative patients).~     Tenofovir is a nucleotide analogue with more potent antiviral activity. In addition, there is~     no cross resistance between the two drugs. Therefore it is assumed that tenofovir would be~     effective in the treatment of chronic hepatitis B patients who shows partial virologic~     response (detectable HBV DNA by real time PCR after 12 months of treatment) despite treatment~     with entecavir. In this study, we will compare the efficacy of switching to tenofovir with~     continuing entecavir in patients who shows partial virologic response to entecavir.~   "
141776|NCT01711554|"~     This phase I trial studies the side effects and best dose of lenalidomide when given together~     with dinutuximab with or without isotretinoin in treating younger patients with neuroblastoma~     that does not respond to treatment or that has come back. Drugs used in chemotherapy, such as~     lenalidomide and isotretinoin, work in different ways to stop the growth of tumor cells,~     either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Monoclonal antibodies, such as dinutuximab, may interfere with the ability of~     tumor cells to grow and spread. Giving more than one drug (combination chemotherapy) together~     with dinutuximab therapy may kill more tumor cells.~   "
141777|NCT01711541|"~     This partially randomized phase I/II trial studies the side effects and best dose of~     veliparib when given together with combination chemotherapy and to see how well they work in~     treating patients with stage IV head and neck cancer. Drugs used in chemotherapy, such as~     docetaxel, cisplatin, and fluorouracil, work in different ways to stop the growth of tumor~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Veliparib may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. It is not yet known whether combination chemotherapy is more~     effective when given with or without veliparib in treating head and neck cancer.~   "
141778|NCT01711528|"~     This phase I trial studies the side effects and best dose of dinaciclib and bortezomib when~     given together with dexamethasone in treating patients with multiple myeloma that has~     returned after a period of improvement. Dinaciclib and bortezomib may stop the growth of~     cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in~     chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer~     cells, either by killing the cells, by stopping them from dividing, or by stopping them from~     spreading. Giving dinaciclib and bortezomib together with dexamethasone may kill more cancer~     cells.~   "
141779|NCT01711515|"~     This phase I trial studies the side effects and best dose of ipilimumab when given after~     chemoradiation therapy in treating patients with stages IB2-IIB or IIIB-IVA cervical cancer.~     Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of~     tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them~     from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink~     tumors. Monoclonal antibodies, such as ipilimumab, may find tumor cells and help carry~     tumor-killing substances to them. Giving ipilimumab together with chemoradiation therapy may~     be a better way treat cervical cancer.~   "
141780|NCT01711502|"~     This is a multicenter, national, retrospective chart-review study that will be based on the~     collection of data from electronical or paper-based medical records with available data on~     female patients diagnosed with metastatic brest cancer . The main purpose of this study is to~     provide accurate, evidence based description on the incidence of progression of metastatic~     breast cancer and its clinical management.~   "
141781|NCT01711489|"~     The purpose of this study is to assess the effect of multiple doses of isavuconazole on the~     pharmacokinetics (PK) of mycophenolate mofetil (MMF) after single dose administration. Safety~     and tolerability of isavuconazole will be assessed alone and in combination with MMF.~   "
141782|NCT01711476|"~     The objective of this study is to investigate the effects of two isocaloric maintenance diets~     with different meal timing distribution on insulin resistance hyperandrogenism and cytochrome~     P450c17 alpha activity in lean PCOS women.~      The investigators hypothesis is that in lean PCOS women a Breakfast Diet (BD) which consist~     in high calorie breakfast and reduced dinner, vs Dinner Diet (DD) which consist in high~     calorie dinner with reduced breakfast; the BD will improve glucose and insulin response to~     OGTT and would decrease the hyperandrogenism and cytochrome P450c17 alpha activity.~   "
141783|NCT01711463|"~     In this study, fluticasone furoate (FF) and vilanterol (VI) in different dose combinations~     (50/25mcg, 100/25mcg and 200/25mcg) will be administered from a single dry powder device to~     evaluate the PD, PK, safety and tolerability of the combination in healthy Chinese subjects.~     The information gathered will be used as a support of the clinical development program of the~     fixed dose combination of FF/VI inhalation powder in Chinese population.~   "
141784|NCT01711450|"~     This study is aimed at assessing whether performing a paravertebral block (a type of regional~     pain relief) can reduce the pain and anxiety patients experience during radiological~     procedures on the liver.~   "
141785|NCT01711437|"~     THE AIM OF THIS STUDY IS TO COMPARE THE EFFICACY, TOLERABILITY, AND SAFETY OF DIFFERENT BOWEL~     PREPARATIONS FOR COLONOSCOPY IN CHILDREN.~      THE AIM OF THIS STUDY IS TO COMPARE THE OVERALL COLON CLEANSING~   "
141786|NCT01711424|"~     This is an observational study of OPTIVE PLUS® in patients with dry eye disease in a routine~     clinical setting. Treatment decisions are made by the physician and reflect the physician's~     current standard of care.~   "
141787|NCT01711411|"~     The study will measure the incidence of moderate and severe adverse events (AEs) associated~     with PrePex procedures, including both procedural and post-procedure events, and all~     device-related incidents such as dislodgment. To assure complete ascertainment of AEs,~     study-specific forms will be used to collect standardized data from the circumcision visit~     and all follow-up visits. Follow-up will be more intensive for the first 50 cases, and will~     revert to routine practice (two follow-up visits) for the remaining 375 cases.~   "
141811|NCT01711099|"~     Clinical research to justify effectiveness of the Extracorporeal Shockwave Myocardial~     Revascularization (ESMR) Therapy for treatment of patients with reversible myocardial~     ischemia secondary to Coronary Artery Disease (CAD) and therapy resistant stable angina~     pectoris.~   "
141788|NCT01711398|"~     The experimental plan will consist in:~      The dose-finding Bayesian adaptive phase I portion of the study is designed to determine the~     optimal and recommended dose of IPP-204106N using a Bayesian with memory design with~     combined toxicity and pharmacokinetic endpoints to determine doses for successive cohorts of~     three patients. The Bayesian methodology allows updating information as the trial progresses~     and stopping the trial as soon as the information obtained is deemed to be sufficient.~     Preclinical toxicokinetic studies of N6L and IPP-204106N in dogs and the first phase I~     clinical trial with N6L will be used to inform the prior distribution in the present study.~      The decisional part, according to the results of the phase I portion of the study, will~     define the optimal dose recommended for the phase IIa portion of the study.~      The phase IIa portion of the study will confirm the optimal dose, and is designed to evaluate~     the safety and the preliminary efficacy of IPP-204106N in an expanded patient population~     treated at the recommended dose of IPP-204106N.~   "
141789|NCT01711385|"~     In an ongoing study new dental patients are screened to determine their risk of having~     undiagnosed pre-diabetes or diabetes based on risk factors readily known by the patient and~     signs of gum disease. Investigators further seek to assess if a post-identification~     intervention leads to a greater likelihood of study participants identified as potentially~     pre-diabetic or diabetic visiting their physician regarding their screening blood test~     results, and to improved health outcomes.~   "
141790|NCT01711372|"~     Current diagnostic aids used in treating ADHD are currently expensive, time intensive, and~     provide little information about accessory movements in response to a stimulus. One in ten~     children, ages 5 to 17, has been diagnosed with ADHD.~      Tests such as the Conners' Rating Scale require subjective responses from parents and~     teachers, making coordination difficult. The computerized Conners' Continuous Performance~     Test (CPT) provides objective data in regards to inattention and impulsive patterns of~     response. However, it does not provide data regarding accessory movements such as~     restlessness, hyperactivity, and other inappropriate movements. If the subject taking the~     exam has a reading disorder, it will impair his or her ability to respond accurately and it~     will increase response time. The T.O.V.A. is another computer based test used as a diagnostic~     aid for ADHD, which uses a microswitch to record responses. It does utilize auditory and~     visual stimuli, which removes the reading level limitation. However, it is unable to measure~     to measure accessory movements that may be contributing to reaction time and errors of~     omission and commission.~      Because of these limitations, a new company called CogCubed has created a new game based on~     the Sifteo Cube (http://www.sifteo.com) platform. These new hands-on digitized cubes are~     unique, motion-sensitive wireless blocks that contain multiple sensors that can interact with~     one another. CogCubed is providing the data for this study. The game will be played in a 30~     minute sessions by subjects ages 6-17. Subjects recruited to play the game will be those with~     ADHD and those without, matched by gender and age. Those with comorbidities of developmental~     delay, mental retardation, psychosis, schizophrenia, bipolar disorder and substance use~     disorders will be excluded, as well as any physiological disability that affects upper limb~     movement and/or coordination. Informed consent will be obtained from parents and patient~     prior to administering the game. Parents will fill out a Conner's Brief Rating Scale and a~     Conner's Brief Rating Scale, Teacher's version will also be supplied to be filled out at~     school.~      The hypothesis is that by analyzing data generated from this new gaming platform named Sifteo~     for which a game was created, which uses auditory and visual stimuli and distracters, the~     investigators expect that they will be able to provide a more accurate profile of impulsivity~     and inattention. The investigators expect that inattention will have more errors of omission~     and less tilt movements than control and impulsivity will be represented as more commission~     and greater tilting movements than control. This trial builds on the previous results of our~     phase 1 trials used to create the predictive algorithms to analyze the data and predict the~     likelihood of ADHD diagnosis based on patterns of game play behavior.~   "
141791|NCT01711359|"~     The purpose of this study is to determine whether baricitinib therapy alone is noninferior to~     methotrexate (MTX) therapy alone in the treatment of moderate to severe active rheumatoid~     arthritis (RA) in those who have had limited or no treatment with MTX and are naive to other~     conventional or biologic disease-modifying antirheumatic drugs (DMARDs).~   "
141792|NCT01711346|"~     The objective of this study is to assess the post-infusion viability of S-303 Red Blood Cells~     (RBC) by measuring the 24 hour post-infusion recovery and lifespan of autologous RBCs~     prepared with the S-303 Treatment System for RBC after storage for 35 days in comparison to~     conventional untreated RBCs stored for 35 days.~   "
141793|NCT01711333|"~     This study is to evaluate symptomatic changes and safety before and after the administration~     of Pletaal® SR Capsules based on Peripheral Artery Questionnaire (PAQ) in subjects with~     peripheral arterial disease symptom due to chronic occlusive arterial disease (COAD).~   "
141794|NCT01711320|"~     In this study, investigators hypothesized that the plasma concentration of metformin and its~     glucose-lowering action would be affected by omeprazole, probably by altering the expression~     or function of OCTs in the liver, its primary target organ, as well as in the kidney.~   "
141795|NCT01711307|"~     The proposed trial is a multi-centre prospective randomized controlled trial comparing~     outcomes of patients with acute Achilles tendon ruptures treated either non-operatively or~     with open operative tendon repair. All patients will undergo accelerated functional~     rehabilitation. The primary outcome measure is Achilles tendon re-rupture rate.~   "
141796|NCT01711294|"~     To document impact of EUS-FNA needle size and flexibility on effectiveness of pancreatic~     cystic lesions (PCL) aspiration, on ability to obtain sufficient material for standard~     diagnostic testing, and on diagnostic accuracy of EUS-FNA aspirate for differentiation of~     mucinous (pre-malignant) and non-mucinous cysts.~   "
141797|NCT01711281|"~     Heart Failure (HF) is one of the most frequent diagnoses upon hospitalization and is a major~     cause of death. Cardiac resynchronization therapy (CRT) using an implantable device for~     synchronous bi-ventricular stimulation leads to improvement of hemodynamic parameters,~     physical capacity and quality of life. A continuous measurement of the left-ventricular~     volume would provide information about heart performance and could be used for both heart~     failure monitoring and optimization of CRT-therapy.~   "
141798|NCT01711268|"~     Sunitinib is an oral drug used for treatment of advanced kidney cancer. The standard dose is~     50mg, but many patients require a dose decrease due to side-effects. Drug levels of sunitinib~     vary approximately 10-fold between patients.~      This study will measure blood levels of sunitinib and its metabolite, and correlate these~     with side-effects and the response to the treatment. The study aims to establish whether~     blood levels change with time, and see how useful blood levels are for monitoring patients~     treated with sunitinib.~   "
141799|NCT01711255|"~     Recent research in multiple sclerosis (MS) have suggested that altered coagulation and~     vascular inflammation may play a role in pathophysiology of MS. Sonoclot is viscoelastic~     method of analyzing clot formation. This instrument will be used to compare coagulation in~     individuals with MS to healthy controls. A 24-hour dietary recall and food frequency~     questionnaire will help determine whether coagulation is modified by fish consumption.~   "
141800|NCT01711242|"~     The objective of the trial is to compare disease-free survival between adjuvant XELOX alone~     vs XELOX with concurrent capecitabine and radiotherapy in curatively resected gastric cancer~     patients with D2 dissection.~   "
141801|NCT01711229|"~     Acetaminophen (Tylenol) is a drug that is used commonly for relief of mild to moderate pain.~     It is found in many pain medicines that people take after having surgery. Narcotics are other~     drugs also used for pain (examples of narcotics are morphine and related pain medications).~     Medical science knows for a fact that acetaminophen works well when taken with narcotics for~     moderate to severe pain. Recently, acetaminophen has become available in an intravenous (IV)~     form called Ofirmev®. The IV form means that acetaminophen can be given into a vein. The~     benefits of getting medicine from an IV include:~        -  making the medicine work quickly~        -  less medicine having to pass through the liver to be changed into a form that your body~          can process The investigators know that acetaminophen is helpful for pain relief at the~          time of surgery and after surgery. Acetaminophen is a very popular drug in outpatient~          surgery for pain control when patients go home. The patient's surgeon uses it to control~          pain after surgery at home in the form of Lortab or Percocet (Lortab and Percocet also~          have a narcotic medicine that mixes with acetaminophen). Also, currently at Surgicare,~          some anesthesiologists give intravenous acetaminophen while the patient is waiting to go~          to surgery. The investigators currently do not give any patient acetaminophen by mouth~          BEFORE surgery. However, since the addition of the IV form to the drug market, there has~          been interest to see if the oral form is just as good or better in reducing pain after~          surgery. This is why we are asking patients to join our study. The goal of this study is~          to find out if the oral form (by mouth) or the IV form (given into a vein) of~          acetaminophen controls pain after surgery better.~   "
141802|NCT01711216|"~     Dydrogesterone is approved in more than 100 countries including Russia, Ukraine, Kazakhstan~     and Uzbekistan and widely used for the treatment of progesterone deficiencies such as for~     management of dysmenorrhea, endometriosis, secondary amenorrhea, irregular cycles,~     dysfunctional uterine bleeding, pre-menstrual syndrome, threatened and habitual miscarriage,~     infertility due to luteal insufficiency, as well as part of hormone replacement therapy.~     There are limited data regarding dydrogesterone's role in achieving cycle regularization from~     post-marketing settings. There is need to assess the persistence of dydrogesterone therapy in~     a post-marketing setting after cessation of treatment and whether the persistence, if any, is~     related to the duration of dydrogesterone therapy. Hence, in this observational program, the~     goal is to observe the possible implications of such treatment in terms of treatment length~     and response pattern.~   "
141803|NCT01711203|"~     Purpose: To determine the effectiveness of an augmented Pilates program, when combined to a~     multimodal strengthening program, for patients under the age of 21, who have spondylolysis~     and/or spondylolisthesis.~      Significance of the topic: Spondylolysis and spondylolisthesis are often diagnosed in~     children and adolescents presenting with low back pain.~      A randomized, clinical trial, test-retest design, with a 3 week and 6 week assessment with~     functional performance test measures, exercise logs, adherence scale for patient and parent~     perception, and outcome measures (Global rating of change (GROC) and Modified Oswestry~     Disability Index (ODI)). This study will attempt to obtain at least 120 subjects that will be~     randomized into two groups: bracing and a general strengthening program vs. bracing and a~     Pilates/motor learning program combined with a general strengthening program.~      This study will begin with an initial examination and continue with treatment sessions~     2x/week for 6 weeks. A follow up phone call will be conducted at 3 months after completing~     the 6-week protocol. The follow up phone call will be an oral conducted GROC and ODI outcome~     measures.~   "
141804|NCT01711190|"~     The aim of this project:~        1. Confirming the modification in corneal astigmatism after trabeculectomy with MMC and~          intracameral administration of bevacizumab.~        2. Medium-term follow up (6 months) of the induced corneal astigmatism.~        3. Investigating correlations between postoperative astigmatism, particularly with the~          postoperative IOP.~   "
141805|NCT01711177|"~     Glaucoma is the second leading cause of blindness among seniors in Canada. It is often~     associated with an elevated intraocular pressure (IOP), but its exact mechanism is still~     largely unknown. Some studies have shown a link between glaucoma and changes in the amount of~     oxygen in the veins of the eye. The study aims to compare the amount of oxygen in ocular~     veins among three different groups using a spectrophotometer. This instrument is linked to a~     camera and can measure the quantity of oxygen in the veins using different characteristics of~     the blood inside.~      The groups of the study are: patients without glaucoma, patients suspected of glaucoma and~     patients newly diagnosed with glaucoma. The drug the investigators are using, Travoprost~     0.004%, will only be administered to the groups suspected or diagnosed with glaucoma.~     Travoprost 0.004% is already approved for use in Quebec and is part of standard care. Ten~     patients will be recruited into each group for a total of 30 patients in this study. All~     patients for the suspected or diagnosed groups will be recruited from the Jewish General~     Hospital. Subsequently all testing will be done at the École d'optométrie, Université de~     Montréal~   "
141806|NCT01711164|"~     Viral hepatitis is a serious world health problem affecting over 1 billion people worldwide.~     Presently the lack of highly effective treatments results in many patients requiring liver~     transplantation or death. The investigators have defined the role of a unique molecule FGL2~     and its receptor fc-gammaR and its role in the pathogenesis of both experimental and human~     hepatitis. The studies proposed in the present proposal will test the hypothesis that~     measuring levels of fgl2 in plasma will identify individuals that will go on to develop~     chronic disease and inhibition of binding of fgl2 to its receptor will allow the host with~     both acute and chronic disease to develop an appropriate immune response and clear the virus.~     The studies will provide rationale for generation of new therapies to improve the treatment~     of patients with acute and chronic viral hepatitis by targeting fgl2.~   "
141807|NCT01711151|"~     1. To evaluate the health status of patients with Interstitial Lung Disease (ILD), and how~          this varies between subgroups of ILD.~        2. To investigate the prevalence of symptoms, anxiety, depression, and sleep-disordered~          breathing within ILD patient population.~        3. To assess the economic impact of ILD.~        4. To understand how self-aware ILD patients are regarding their treatment/management.~        5. To compare the demographic details, including smoking status and occupational history,~          of patients with interstitial lung disease~   "
141808|NCT01711138|"~     The purpose of this study is to evaluate if changes to the built environment influence~     physical activity and active transport to school in children and youth.~   "
141812|NCT01711086|"~     Double-blind study, randomized, controlled, and crossover. Study recruited 30 volunteers with~     stable asthma aged 8-18 years. Participants will perform lung function as part of the routine~     follow-up then will receive a Foradil 12mcg either with an Aerolizer (a standard dry powder~     inhaler) or with the Inspiromatic (an active, breath synchronized innovative inhaler). 3-60~     days later participants will receive the same drug through the other inhaler.~      Pre and post treatment (15 min, 30 min, 60 min) Lung function results, drug levels in the~     blood, vital signs and side effects will be recorded.~   "
141813|NCT01711073|"~     A phase I trial to study the safety of mobilization of stem cells with G-CSF and Mozobil in~     patients with chronic liver disease.~   "
141814|NCT01711060|"~     Increasing cesarean rate in France is worrying. Different methods are described for ripening~     labor : the use of prostaglandins is described but maybe dangerous for patients with scarred~     uterus and is not recommended.~      Intracervical balloon is an efficient alternative methods which as already been tested for~     unfavorable cervix ripening on nulliparous women.~      But it was rarely tested on women with scared uterus and unfavorable cervix (bishop score~     <4).~      The investigators propose a prospective randomised trial comparing cervix ripening with~     intracervical balloon inflated by 50 ml sterile water during 12 hours versus ocytocin~     (reference method).~      The investigators expect to demonstrate what it's a safe method to increase vaginal delivery~     for women with previous cesarean section who need an induction of labour.~   "
141815|NCT01711047|"~     The optimal strategy for catheter ablation of persistent atrial fibrillation is not clearly~     defined. This study investigates if Complex Fractionated Atrial Electrogram (CFAE) ablation~     in addition to pulmonary vein isolation and linear ablations improves single procedural~     success rate over a 12 month follow up period.~   "
141816|NCT01711034|"~     The primary objective of this study is to determine the safe and tolerable dose level of~     OPB-111077 for patients with advanced cancer.~   "
141817|NCT01711021|"~     This study will evaluate safety and efficacy of d-Amphetamine Transdermal System for the~     treatment of Attention Deficit Hyperactivity Disorder in children and adolescents.~   "
141818|NCT01711008|"~     Both regular exercise and breakfast consumption have well known health benefits. Consuming~     breakfast prior to morning exercise may influence appetite, mood and cognitive function later~     in the day. The purpose of this study is to test whether the amount of food consumed at~     breakfast prior to exercise influences these parameters in active women.~   "
141819|NCT01710995|"~     The purpose of this study is to assess the effectiveness of Zegerid 20mg capsules and powder~     and Losec 20mg capsules in healthy volunteers under fasting conditions.~   "
141820|NCT01710982|"~     A study to evaluate the safety of TZP-101 in comparison with placebo when administered~     post-operatively in patients who have undergone partial bowel resection.~   "
141821|NCT01710969|"~     The planned study will randomly assign aggressive children to one of two versions of the~     Coping Power child component. The two versions of Coping Power will either deliver the child~     component of the program in the usual small group format (Group Coping Power: GCP) or in a~     newly-developed individual format (Individual Coping Power: ICP). By providing a direct~     comparison of two different formats of the same intervention, the planned study's design will~     fill a critical gap in our current understanding of the relative effectiveness of group vs.~     individual programs. Further, this study will allow for examination of the specific factors~     that influence relative effectiveness of these two formats, important information with broad~     implications for program development, training of clinicians, and intervention~     implementation.~   "
141822|NCT01710943|"~     The proposed study involves developing and evaluating an interactive, web-based CBT~     intervention for OEF/OIF Veterans with hazardous or problematic substance use and PTSD~     symptoms (PTSD or subsyndromal PTSD). The intervention will address the special culture and~     experiences of the investigators targeted population (OEF/OIF Veterans). The web-based CBT~     intervention includes 24 modules, to be used across 24 sessions targeting OEF/OIF Veterans~     with hazardous or problematic substance use and PTSD symptoms. The investigators ask~     participants to complete 2 sessions per week (one module per session) for 12 weeks. The first~     18 modules to be completed across 18 sessions (9 weeks) are considered core modules relevant~     to all Veterans in the target population. These modules are designed to reduce posttraumatic~     stress symptoms as well as reduce and prevent the escalation of problematic substance use.~     The remaining 6 module topics are considered optional and are used based on the interest~     and clinical need of various sub-groups of VA patients. The study includes initial input as~     well as feedback on a beta version from experts who have worked with OEF/OIF veterans with~     PTSD and substance abuse problems as well as input/feedback from the target population (the~     Veterans themselves). In addition to presenting content grounded in evidence-based CBT~     interventions, the program also employs state of the art technologies to deliver module~     content grounded in evidence-based learning principles, including Computer-Assisted~     Instruction, Computer Simulation and other interactive exercises.~   "
141823|NCT01710930|"~     The main objective of this study is to determine if a doubling of serum TARC (compared to~     baseline) is associated with the occurrence of exacerbations of ABPA.~      The secondary objectives of the study are :~        1. To investigate if induced sputum eosinophils count (compared to baseline) is associated~          with the occurrence of exacerbations.~        2. To examine if the exhaled NO (compared to a baseline) is associated with the occurrence~          of exacerbations.~        3. To investigate if activation of circulating T cells (compared to a baseline) is~          associated with the occurrence of exacerbations.~        4. To examine if the rate of specific Asp f IgG measured by ELISA (compared to a baseline)~          is associated with the occurrence of exacerbations.~        5. To determine if the variation of one of the markers above, TARC or Asp f specific IgE~          measured at baseline, may be associated with the radiological stage of the disease~          (ABPA-S, ABPA-CB, ABPA-ORF).~        6. To investigate if there is a link between fungal exposure at home (visually assessed by~          the contamination level and the proportion of positive samples for Asp. f) and the~          frequency of exacerbations.~        7. To establish if some of the clinical, functional or biological data studied are~          associated with the frequency of exacerbations.~   "
141824|NCT01710917|"~     This non-interventional, observational study evaluates the efficacy of Targinact with regard~     to quality of life in daily clinical practice in Belgium compared to the previous analgesic~     treatment.~   "
141833|NCT01710800|"~     The purpose of this study is to determine the effects of proton pump inhibitors (PPIs) on the~     total number of reflux episodes in the distal esophagus measured by impedance in patients~     with and without gastroesophageal reflux disease (GERD) based on 24-hour pH testing. In~     addition to changing the acidity of the refluxate, the investigators hypothesize that PPIs~     also reduce the total number of reflux episodes due to its anti-secretory effects.~   "
141834|NCT01710787|"~     The purpose of this study is to compare the efficacy of Kovacaine Mist, Tetracaine only, and~     Placebo for inducing pulpal anesthesia of the maxillary teeth in adults.~   "
141835|NCT01710774|"~     This study will investigate whether telemedicine follow-up care for people with~     diabetes-related foot ulcers in municipal primary health care in collaboration with~     specialist health care is an equivalent alternative to traditional outpatient clinical~     follow-up in specialist health care (noninferiority trial) in relation to healing time.~   "
141836|NCT01710761|"~     Acute supplementation of Neo40(TM), a nitrate lozenge, will improve cycling performance~   "
141837|NCT01710748|"~     This study is a prospective, randomized controlled, single blind, two-arm, multicenter~     clinical evaluation.~      Diabetic patients (n=112) with de novo coronary artery disease will be randomized to one of~     the 2 treatment arms: 1) Reservoir-Based Polymer-Free Amphilimus-Eluting Stent or 2)~     Polymer-Based Everolimus-Eluting Stent.~      The purpose of this study is to determine whether Polymer-Free Amphilimus-Eluting Stent~     implantation is effective in reducing neointimal hyperplasia as compared to Polymer-Based~     Everolimus-Eluting Stent in diabetic patients, using Optical Coherence Tomography (OCT) as~     the primary imaging modality.~   "
141838|NCT01710735|"~     In relation to Myofascial Triggerpoints (MFTrPs) of the upper Trapezius, this study will~     explore muscle contractility characteristics, the occurrence of post-intervention muscle~     soreness and the effect of dry needling on muscle contractile characteristics and clinical~     outcomes.~   "
141839|NCT01710722|"~     The purpose of this study is to compare three treatments to see which causes the most weight~     loss, fat loss, loss of stomach fat and improvement in blood tests like cholesterol.~   "
141840|NCT01710709|"~     This will be an open-label uncontrolled trial to evaluate the safety and tolerability of~     aripiprazole IM depot administered every 4 weeks for up to 52 weeks to patients with bipolar~     I disorder. The trial will enroll subjects who completed Trial 31-08-250 and de novo subjects~     not participating in Trial 31-08-250.~   "
141841|NCT01710696|"~     This trial is conducted in Europe. The aim of the trial is to induce normal pubertal~     development in girls with Turner Syndrome in accordance with that of their peers and their~     individual state psychosocial maturation.~   "
141842|NCT01710683|"~     After lumbar discectomy 1st postoperative day high intensity exercise training reduced~     hospital stay, pain and sick leave without side effects in the two year follow-up period.~   "
141843|NCT01710670|"~     To evaluate if Brivaracetam (BRV) influences the psychomotor and cognitive impairing effects~     of Ethanol~   "
141844|NCT01710657|"~     The purpose of this study is to evaluate the efficacy and safety of 200 and 400 mg/day of~     orally administered Lacosamide as adjunctive therapy compared with placebo in Japanese and~     Chinese adults with uncontrolled Partial-Onset Seizures with or without secondary~     generalization.~   "
141845|NCT01710644|"~     The purpose of this Randomized, Double-blind, Multicenter, Two-period Crossover Study is to~     Assess the Efficacy and Tolerability of Burlulipase (NM-BL) in Patients with Exocrine~     Pancreatic Insufficiency due to Cystic Fibrosis~   "
141846|NCT01710631|"~     A six-month study to determine the safety and efficacy with an additional open-label~     extension to determine the long-term safety of eszopiclone in the treatment of adult subjects~     with primary insomnia.~   "
141847|NCT01710618|"~     The purpose of the study is to elucidate the different proteins that may appear on the~     injured end of the sciatic nerve and compare it to the other end of the cut nerve, which is~     uninjured. By comparing the normal versus traumatized ends of the cut sciatic nerve,~     the investigators hope to identify proteins that may be specifically related to pain. For~     instance, if the non-traumatized end of the nerve has none of Protein X but the traumatized~     end of the nerve has a lot of Protein X, then Protein X would be a protein that the~     investigators will want to study further and see if it plays any role in the sensation of~     pain.~      Other studies have shown that there are specific pain-related proteins and they may be~     increased or decreased after traumatic injury. If the investigators are able to identify~     specific proteins that are related to pain, then that may eventually lead to the development~     of medications that will block those proteins and decrease the sensation of pain.~   "
141848|NCT01710605|"~     The STIC CTC study is a randomized trial to evaluate the medico-economic interest of taking~     into account circulating tumor cells (CTC) to determine the kind of first line treatment for~     metastatic, hormone-receptors positive, breast cancers. In the standard arm, the kind of~     treatment will be decided by clinicians, taking into account the criteria usually used in~     this setting. In the CTC arm, the type of treatment will be decided by CTC count:~     hormone-therapy if <5CTC/7.5mll (CellSearch technique) or chemotherapy if =5. The main~     medical objective is to demonstrate the non-inferiority of the CTC-based strategy for the~     progression-free survival: 994 patients are needed, and will be accrued in French cancer~     centers. Secondary clinical objectives are to compare toxicity, quality of life and overall~     survival between the two arms. The medico-economic study will compare cost per~     progression-free life years gained of the two strategies. The financial impact of centralized~     (one platform) vs decentralized (several platforms) CTC testing will be evaluated.~   "
141849|NCT01710592|"~     Whilst oxaliplatin and docetaxel have established activity in the treatment of advanced~     gastro-oesophageal cancer, their role, however, in the management of this disease remains~     unclear. Furthermore it is unclear whether this disease is optimally treated with a~     combination of two or three cytotoxic drugs. This trial aims to determine whether the~     combination of oxaliplatin and weekly docetaxel warrants further investigation in a formal~     phase III trial. The combination of epirubicin, oxaliplatin and capecitabine will be the~     comparator arm for this evaluation.~      Primary Objective:~      Determine in a randomised study if the response rate to docetaxel and oxaliplatin (ElTax) is~     comparable to epirubicin, oxaliplatin and capecitabine (EOX) and warrants further evaluation~     in advanced gastro-oesophageal cancer.~      Secondary Objective:~      To examine the effect of treatment on time to progression, progression free survival, overall~     survival, quality of life, and the associated toxicity from treatment.~   "
141850|NCT01710579|"~     Ano-rectal manometry is indicative in patients with either fecal incontinence or~     constipation. Recently anorectal 3D- high resolution manometry has been developed. Pressure~     variations are measured circumferentially along the anal canal. It may allow a better~     understanding of anorectal disorders by displaying anal pressure asymmetry and it could be~     useful to assess the functional anatomy of the pelvic floor better than conventional~     manometry.~   "
141851|NCT01710566|"~     This community-based cluster Randomised Control Trial will assess the feasibility, cost,~     risks and benefits of use of oral Misoprostol and parenteral Oxytocin in Uniject® as~     prophylaxis for postpartum hemorrhage (PPH) in community settings. The study will be~     conducted in Jamnagar district in Gujarat state in India. The hypothesis is that a program to~     deliver oral misoprostol and one to deliver oxytocin via Uniject® will both be effective in~     preventing PPH when introduced in community-based settings.~   "
141852|NCT01710553|"~     A randomized, balanced, open label, crossover, two period, two treatment, two sequence,~     single dose, oral bioequivalence study under fasting condition. It is a pivotal study to~     demonstrate the bioequivalence of Metformin 1000 mg tablets manufactured by Savipharm J.S.C,~     Vietnam and Glucophage® 1000 mg tablets of Merck Sante, France in healthy adult human male~     subjects under fasting condition~   "
141853|NCT01710540|"~     A randomized, balanced, open label, crossover, two period, two treatment, two sequence,~     single dose, oral bioequivalence study under fasting condition. It is a pivotal study to~     demonstrate the bioequivalence of Metformin 850 mg tablets manufactured by Savipharm J.S.C,~     Vietnam and Glucophage® 850 mg tablets of Merck Sante, France, in healthy adult human male~     subjects under fasting condition.~   "
141854|NCT01710527|"~     A randomized, balanced, open label, crossover, two period, two treatment, two sequence,~     single dose, oral bioequivalence study under fasting condition. It is a pivotal study.~      To demonstrate the bioequivalence of Metformin 500 mg tablets manufactured by Savipharm~     J.S.C, Vietnam and Glucophage® 500 mg tablets of MERCK SANTE in healthy adult human male~     subjects under fasting condition and to monitor the safety of the study subjects.~   "
141855|NCT01710514|"~     The purposes of the study are to verify sufficient supplementation of luteal hormone after~     administrating FE999913 Vaginal Tablet twice a day (BID) or three times a day (TID) and to~     determine the efficacy and safety of FE999913 Vaginal Tablet in Japanese women undergoing~     fertility treatment with IVF-ET (a fresh embryo transfer).~   "
141856|NCT01710501|"~     This is a study designed to compare the safety and efficacy of 3 different doses of~     grazoprevir (MK-5172) combined with pegylated interferon alfa-2b (PEG-IFN) and ribavirin~     (RBV) in treatment-naïve participants with genotype 1 (GT1) chronic hepatitis C (CHC).~     Participants will receive 12 weeks of treatment with grazoprevir combined with Peg-IFN and~     RBV, and depending on response at Week 4 may go on to receive an additional 12 weeks of~     treatment with Peg-IFN and RBV.~   "
141857|NCT01710488|"~     The primary objective of the study is to determine the percentage of patients with~     therapeutic success at the end of the cycle of antibiotic therapy (10 days), in the two~     treatment groups (levofloxacin and prulifloxacin). The effect of study treatments will be~     evaluated on the basis of a score determined in relation to the signs-symptoms of acute~     exacerbation of COPD (sputum purulence, sputum volume, cough, dyspnea, fever)~   "
141858|NCT01710462|"~     This superiority phase III study to compare the combination of Pantoprazole and Domperidone~     with Pantoprazole isolated to the treatment of gastroesophageal reflux disease. The~     hypothesis is that combination of the two medication at the unique capsule is better to the~     patients because decrease the quantity of times the patients need to take medicines during~     the day.~   "
141859|NCT01710449|"~     An open label study in 40-60 subjects with diagnosed lung airway disease and in 10-20 normal~     controls. Each subject will receive PFP as a contrast agent to visualize the airway and~     alveolar spaces in their lungs using magnetic resonance imaging of inert gas/oxygen mixtures.~   "
141860|NCT01710436|"~     This study is a prospective, observational study to estimate the relationship between dosage~     of clopidogrel and platelet aggregation in Chinese with different genotype. The investigators~     suppose both pretreatment dosage of clopidogrel before percutaneous coronary intervention~     (PCI) and CYP2C19 genotype may effect the platelet aggregation as well as clinical outcome.~   "
141861|NCT01710423|"~     This study aims to test the effectiveness of a community-located, peer mentored intervention~     to improve home food preparation practices in families with young children.~   "
141862|NCT01710410|"~     The purpose of this study is to determine the effectiveness of transcranial direct current~     stimulation (tDCS) plus nicotine patch as a viable smoking cessation program for nicotine~     dependent smokers.~   "
141863|NCT01710397|"~     One of the most serious challenges facing antiretroviral therapy (ART) programs for HIV/AIDS~     in resource-constrained settings is the failure of ART-eligible patients to complete the~     steps required to initiate treatment. The high rate of loss to care of patients who are~     treatment-eligible at HIV diagnosis may be due in part to the large number of steps required~     between receiving an HIV diagnosis and obtaining the first dose of antiretrovirals (ARVs). In~     South Africa, these steps usually require approximately four clinic visits over a period of~     2-8 weeks before a patient can start treatment. One strategy proposed for reducing losses~     among those eligible for ART is to simplify and condense the steps required for starting~     treatment. This is now possible because new, point-of-care (POC) tests for CD4 counts and~     tuberculosis (TB) diagnosis are available. These technologies can be combined with changes to~     clinic schedules to allow all steps required for ART initiation under South African~     guidelines (lab tests, physical exam, education) to take place on the day the patient~     presents for an HIV test.~      This study is a randomized strategy evaluation of the feasibility, effectiveness, and~     cost-effectiveness of rapid ART initiation. Outpatient, non-pregnant, HIV-positive adults who~     come to a South African clinic for an HIV test, consent to study participation, and are~     eligible for ART will be randomized 1:1 to rapid ART initiation or to standard care. Those~     who are assigned to rapid ART initiation will have the possibility of receiving their first~     dose of ARVs as early as the same day, while those who are assigned to standard care will~     follow the clinic's usual procedures for starting ART. Rapid ART initiation for HIV-positive~     pregnant women, which has recently become the standard of care in South Africa, will also be~     assessed in a programmatic evaluation conducted alongside the randomized evaluation, with a~     retrospective comparison group. The primary study outcome for non-pregnant adults will be~     remaining alive, in care and virally suppressed 10 months after having a positive HIV test at~     the study site or making a first HIV-related visit. The primary study outcome for pregnant~     women will be adherence to ART until delivery. The cost effectiveness of the rapid initiation~     strategy will be assessed as the cost per patient achieving the primary outcome for each~     population.~   "
141864|NCT01710384|"~     To test the effect on premature infants of a one-time course of betamethasone administered in~     weeks 34-36 of gestation.~   "
141865|NCT01710371|"~     To evaluate 18F-AV-133 imaging of the pancreas in patients with early type 2 diabetes, late~     type 2 diabetes, subjects with pre-diabetes and in healthy overweight/obese control subjects.~     These subjects will also be evaluated for beta-cell function as measured by the insulin and~     C-peptide response to a challenge with intravenous arginine under basal and glucose enhanced~     conditions.~   "
141869|NCT01710319|"~     The purpose of this research study is to investigate the differences in natural killer (NK)~     blood cells, a type of white blood cell that fights infection in the body, among different~     types of patients that have lung surgery. The four different groups of patients are:~        -  smokers with lung cancer~        -  smokers without lung cancer~        -  non-smokers with lung cancer~        -  non-smokers without lung cancer.~   "
141870|NCT01710306|"~     Women and Reserve/National (RNG) Veterans are among the fastest growing groups of new VA~     users. While PTSD is prevalent in this group, most women don't access or complete needed~     treatment. This study will investigate OEF/OIF/OND RNG female war Veterans' perceptions,~     preferences, barriers and facilitators to accessing VA mental health (MH) and evidence-based~     PTSD psychotherapy. This information will be used to revise an existing web-based screen that~     educates participants about their unique post-deployment MH conditions. This web-interface~     will then be used to randomly assign women who screen positive for PTSD to either 1) a~     concierge nurse case manager who uses shared decision-making to engage Veterans in EBP or 2)~     usual outreach to determine what engagement approach women prefer. The investigators'~     findings will provide VA leaders with key information to understand and improve access to RNG~     PTSD treatment.~   "
141871|NCT01710293|"~     Many missed and delayed cancer diagnoses result from breakdowns in communication and~     coordination of abnormal findings suspicious for cancer, which often first emerge in the~     primary care setting. Delays in the follow-up of abnormal test results persist despite the~     reliable delivery of test results through the electronic health record.~      This intervention is the final study in a three-phase project that will develop and test an~     innovative automated surveillance intervention to improve timely diagnosis and follow-up of~     five common cancers in primary care practice.~      The investigators hypothesize that the median time in days from diagnostic clue to follow-up~     action (e.g. time to colonoscopy examination after am abnormal colon-related test) will be~     significantly less in the intervention arm than in usual care. The investigators also~     hypothesize that the proportion of patients receiving appropriate and timely follow-up care~     will be significantly higher in the intervention arm than in usual care.~   "
141872|NCT01710280|"~     The purpose of this study is to determine whether high-fat meals rich in palmitic acid in the~     sn-2 position decrease lipaemia in men aged 40-70 y with higher than optimal fasting~     triacylglycerol concentrations.~   "
141873|NCT01710267|"~     Rivaroxaban (RXA; brand name Xarelto®) is an oral direct factor Xa inhibitor that is applied~     for prophylaxis of venous thromboembolism after major orthopedic surgery. Additionally, RXA~     is approved by Swissmedic to be used at a therapeutic dose for primary therapy of VTE and for~     prophylaxis of cerebrovascular events in non-valvular atrial fibrillation.~      This is an explorative laboratory study to evaluate the intra-individual variability of RXA~     conc. in time and to standardize assays among 9 Swiss laboratories to determine RXA conc.~   "
141874|NCT01710254|"~     Atrial fibrillation (AF) is growing into an epidemic affecting 1 in 4 adults. There is a need~     for research to elucidate the prevalence of ischemic cardiomyopathy in patients diagnosed~     with AF. The objective of this study is to demonstrate the utility of MRI in assessment of~     coronary artery disease. The specific objective is to demonstrate sensitivity/specificity~     comparable to that reported in meta-analyses of non-AF patients and adenosine (90% /80%) in~     an AF population using the time-efficient vasodilator regadenoson that requires only a single~     intravenous (IV).~   "
141875|NCT01710228|"~     This study is being done to determine the difference between natalizumab therapy followed by~     two different withdrawal strategies using Glatiramer Acetate (GA) treatment paradigms in~     preventing clinical relapses and other markers of disease activity in patients diagnosed with~     Multiple Sclerosis (MS).~      We hypothesize that GA plus corticosteroids versus GA alone will prevent or reduce the~     re-occurrence of MS disease activity after discontinuation of natalizumab over a 12 month~     period. We further hypothesize that natalizumab therapy followed by GA treatment allows the~     reconstitution of the peripheral and CNS immune homeostasis.~      Primary objective:~      The primary endpoint will be the annualized relapse rate over the post randomization months~     as well as estimates of change over the natalizumab therapy period over the entire 12 months.~      Secondary objectives:~      To determine if and how long it takes for restoration of immune homeostasis under GA therapy~     following discontinuation of natalizumab.~   "
141876|NCT01710215|"~     Colorectal cancer (CRC) is the 2nd leading cause of cancer death in the US, though CRC death~     can be reduced by screening. However, there is uncertainty as to which screening strategy is~     most clinically and cost-effective from a population perspective where the aim is to optimize~     completion of the entire screening process continuum. Modeling studies suggest benefits and~     harms of colonoscopy and stool blood test strategies are similar, but generally assume 100%~     participation and subsequent clinically appropriate follow up--something never achieved in~     clinical practice. Comparative effectiveness studies of testing strategies, including~     comparisons of specific tests and approaches to optimizing effective test use, are necessary.~     Safety-net health systems care for populations at increased risk for adverse CRC outcomes,~     such as the uninsured and minorities, and have more limited resources. Therefore, safety-nets~     must resolve the uncertainty regarding the most effective screening strategy. The~     investigators will conduct a system-level, randomized comparative effectiveness trial of the~     benefits, harms, and costs of 3 screening strategies over 3 years, among 6000 patients age~     50-64 years, who are not up-to-date with CRC screening, served by a large safety net health~     system. The three strategies studied will be: 1) Fecal immunochemical testing, with annual~     mailed invitation outreach (including a test kit), and a centralized process to promote~     participation and complete clinical follow up (FIT); 2) Colonoscopy, with annual mailed~     invitation outreach, and a centralized process to promote participation and complete clinical~     follow up (Colo); 3) Usual Care, with no mailed invitation outreach, and screening offered at~     primary care visits. The primary measure of benefit will be an outcome measure that~     summarizes patient-specific effective screening successes. The primary measure of harm will~     be screening non-participation. The primary measure of cost will be cost per-patient~     effectively screened. Our specific aims are to: 1) Compare benefits, harms, and costs of a~     FIT strategy versus a Colo strategy for CRC screening among patients not up-to-date with~     screening, and 2) Compare benefits, harms, and costs of a) the FIT strategy vs. Usual Care~     and b) the Colo strategy vs. Usual Care for CRC screening.~   "
141877|NCT01710202|"~     The current study will test the causal relationship between elevated levels of cortisol and~     the serotonin transporter gene (5-HTTLPR) as these factors influence sensitivity to~     environmental threat. The investigators predict that carriers of the short allele of the~     serotonin transporter gene who have elevated cortisol levels will be most sensitive to~     threatening environments, whereas carriers of the long allele who do not have elevated~     cortisol (placebo subjects) will be least sensitive.~   "
141920|NCT01709643|"~     The major research objective is to assess the potential of Proton Magnetic Resonance~     Spectroscopy to follow Intrahepatic lipid and Intramyocellular lipid dynamics after a single~     meal. Furthermore we aim to investigate whether the addition of protein to a high fat~     breakfast results in a reduced postprandial accumulation of lipids when compared to a high~     fat breakfast alone.~   "
141921|NCT01709630|"~     Determine significant correlations between maternal serum magnesium levels, and maternal and~     neonatal outcomes.~   "
141878|NCT01710189|"~     Many viral infections of global importance, including HIV, are transmitted across the mucosal~     surface of the genital tract. As immunity against these infections is likely to be primarily~     mediated by antibodies in mucosal secretions, developing techniques to increase the levels~     and persistence of antiviral antibody on mucosal surfaces may enhance the protection against~     a number of important infections. Preclinical studies have anatomically targeted vaccine~     antigens to sites where genital tract immunity is induced. This response is likely due to the~     ability of regional lymph Preclinical studies have anatomically targeted vaccine antigens to~     sites where genital tract immunity is induced. This response is likely due to the ability of~     regional lymph nodes to pattern the cell surface markers of responding vaccine specific~     lymphocytes with homing markers. In contrast, injecting a distant muscle (such as in the arm)~     which shares no anatomical relationship with the vagina, may not pattern cells with homing~     markers for the genital tract. Direct injection of inguinal lymph nodes is impractical in~     humans but intramuscular injection into the thigh will target antigens to the deep inguinal~     lymph nodes shared in common with the cervix/vagina.~      This study will be a Phase IV randomised, single centre, open label, laboratory assessment~     blinded exploratory trial to assess mucosal immunogenicity following three targeted~     intramuscular immunisations with TicoVac vaccine. 20 subjects will be randomised to each of2~     groups immunised in right deltoid or right anterolateral thigh.~      Following an initial screening visit subjects will be immunised at 0, 1 and 6 months. There~     will be follow up visits 5 days after each immunisation and a final visit at 7 months. Blood~     samples and cervicovaginal secretions will be taken prior to each immunisation for~     immunological measures. In addition, blood samples will be taken at each immunisation and~     follow up visit for measurement of peripheral blood mononuclear cells.~      The study is funded by ADITEC, which is a collaborative research programme that aims to~     accelerate the development of novel and powerful immunisation technologies for the next~     generation of human vaccines.~   "
141879|NCT01710176|"~     This is a randomized Phase III clinical trial in the setting of localized high-risk soft~     tissue sarcomas (STS). This study will compare a standard neoadjuvant chemotherapy with~     epirubicin plus ifosfamide versus a histology-driven chemotherapy, i.e. a chemotherapy~     tailored to the specific histology within the family of adult STS. Chemotherapy will be~     administered for 3 cycles. There will be five histological groups (representing 80% of STS),~     as follows: leiomyosarcoma, myxoid liposarcoma with hypercellularity (round cell MLPS),~     synovial sarcoma, malignant peripheral nerve sheath tumor (MPNST) and undifferentiated~     pleomorphic sarcoma. The histology-driven chemotherapy for these groups will be,~     respectively, gemcitabine plus dacarbazine, trabectedin, high-dose ifosfamide, ifosfamide~     plus etoposide, gemcitabine plus docetaxel. Other histological groups will also be included~     and registered, but treated only by standard chemotherapy. Patients who have already~     undergone definitive surgery will receive treatment post-operatively and patients needing a~     re-excision after inadequate surgery will be treated as patients in the two groups, but of~     course will not be evaluable for response. A centralized pathological review will be~     performed. Radiological response will be evaluated according to RECIST and to Choi criteria.~     Pathological response will also be recorded.~      The endpoint will be disease-free survival (DFS) and, secondarily, overall survival (OS) of~     patients receiving standard chemotherapy versus those receiving histotype-tailored~     chemotherapy. Additional aims will be to compare the probability of response of standard vs~     histotype-tailored chemotherapy and to determine the radiological and pathological response~     with standard chemotherapy vs tailored chemotherapy in each different histological group.~     Another aim will be to validate the response (both radiological and pathological) to~     preoperative chemotherapy as a surrogate endpoint for DFS and OS.~      Three hundred patients will be randomized over a 3-years period, from a pool of 400-450~     registered patients.~      Translational research will be performed. Areas of research will include identification and~     validation of the potential predictive markers for each histological subgroups.~      The study is designed to verify the statistical hypothesis that histotype-tailored approach~     is associated, overall, with a 30% reduction in the hazard of relapse. However, in each~     different histological group, the effect of histotype-tailored chemotherapy, as compared to~     standard chemotherapy, can be different. To address this weakness an orthogonal study of~     response to chemotherapy as a surrogate of DFS and OS has been introduced into the trial.~     This study intends to extensively investigate the response (radiological and pathological) to~     preoperative chemotherapy and to validate it as a surrogate endpoint by showing that it~     correlates with disease free survival and overall survival.~   "
141880|NCT01710163|"~     The purpose of this study is to determine whether Bipolar I Disorder refractory treatment~     with Quetiapine monotherapy could be better potentiated with Lithium or Aripiprazole. The~     investigators hypothesized that Lithium or Aripiprazole would provide similar compliance and~     tolerability in maintenance treatment.~   "
141881|NCT01710150|"~     The purpose is to compare long term occurrence of atrial arrhythmias including atrial~     fibrillation (AF) and thromboembolic complications including cerebrovascular events (CVE) in~     patients with typical atrial flutter (AFLT) undergoing cavo-tricuspid isthmus (CTI) ablation~     alone versus CTI ablation combined with pulmonary vein isolation (PVI).~   "
141882|NCT01710137|"~     Among people diagnosed with HIV/AIDS, the widespread use of highly active antiretroviral~     therapy (HAART) has greatly improved survival rates and changed the leading causes of death,~     from AIDS-related diseases to cardiovascular disease and lung cancer. Rates of tobacco use~     among individuals with HIV/AIDS are very high and varenicline may be particularly efficacious~     for treating nicotine dependence among individuals with HIV/AIDS. Through this trial, 310~     smokers with HIV/AIDS will be randomized to varenicline plus 9 weeks of smoking cessation~     counseling or placebo plus 9 weeks of smoking cessation counseling. The investigators~     hypothesize that 1) varenicline and counseling will significantly increase end-of-treatment~     (week 12) and 24-week biochemically-confirmed abstinence, versus placebo and counseling; 2)~     quality of life will be rated higher in the varenicline and counseling group versus the~     placebo and counseling group, and there will be no significant differences between treatment~     arms in terms of the frequency of severe varenicline-related side effects; and 3) improved~     affect and reduced cognitive impairment will mediate the effect of varenicline therapy on~     quit rates.~   "
141883|NCT01710124|"~     The prevalence of overweight and obesity among older adults has reached an all-time high,~     which puts this age group at high risk for associated comorbidities such as type 2 diabetes,~     cardiovascular disease, and certain forms of cancer. Confronted with declining incomes and~     economic uncertainty, many middle-aged and older Americans tried to save on their food~     purchases during the 2007-2009 recession. Grocery coupons, available through newspapers,~     mail, and increasingly online, are one of several promotional tools that supermarkets and~     warehouse clubs use to promote sales. It is estimated that nationally 27% of households are~     frequent grocery coupon users who shop at a variety of retailers. Despite the increasing~     popularity of grocery coupons, little is known about the extent to which they may promote~     obesogenic home food environments and eating behaviors. Many coupons advertise the purchase~     of large quantities of prepackaged and processed foods and often reward shoppers by adding~     'free' products if they purchase certain quantities. Availability and easy accessibility of~     large portions of energy dense foods in the home has been shown to promote increased intake.~     The proposed study seeks to examine the effects of frequent grocery coupon usage on dietary~     intake, weight status, and home food availability among middle-aged and older adults. A~     second aim of this study is to test, in a randomized-controlled trial, the effects of~     incentivizing grocery coupon use for the purchase of healthy foods on 3-month changes in~     dietary intake, body mass index/waist circumference, home food availability, and grocery~     coupon use among frequent coupon users and non-coupon users.~   "
141937|NCT01709422|"~     The purpose of this study is to compare efficacy and safety of combination of propofol and~     midazolam with meperidine versus midazolam and meperidine for ambulatory ERCP~   "
141948|NCT01709279|"~     Mesenchymal stem cells have capability to differentiate into myocardium, vascular endothelial~     cell, vascular smooth muscle cell and will be useful for heart regeneration. Adipose tissue~     is relatively enriched with mesenchymal stem cell compared to bone marrow tissue. In this~     trial, eligible ischemic heart failure patients will be proceeded intracoronary~     administration of autologous adipose tissue derived stromal cells by cardiac catheterization.~   "
141884|NCT01710111|"~     The ways in which influenza is transmitted between people are uncertain; for example, we do~     not know if large droplets or fine particles (aerosols) matter most; both are produced by~     coughing and sneezing. This means we cannot say what precautions work best in real life.~     Improving our understanding is vital to allow the development of guidelines and policies to~     help reduce the transmission of both pandemic and seasonal flu.~      The aim of this study is to explore how influenza is spread, specifically by looking at the~     importance of spread via small particles (aerosols/droplet nuclei) that are carried in~     respiratory sprays e.g. produced by coughing and sneezing.~      The primary objective of this study is:~      To estimate the contribution of aerosols/droplet nuclei to influenza transmission by~     determining the secondary attack rate (SAR) of influenza in Recipients randomised to a~     control arm (no intervention - allowing all modes of transmission) compared to Recipients~     randomised to an intervention arm (face shield and hand hygiene - allowing only transmission~     by aerosols/droplet nuclei) when both groups of Recipients are exposed to Donor volunteers~     infected with influenza via intranasal drops.~      The hypothesis is that:~      The SAR will be lower in Recipients exposed only to aerosols/droplet nuclei (intervention~     arm) compared to those exposed to all modes of transmission (the control arm):~     aerosols/droplet nuclei, droplet spray (larger respiratory droplets) and transmission through~     contact.~   "
141885|NCT01710098|"~     How are testosterone levels of patients with prostate cancer under treatment with Firmagon®~     changing.~      Former studies showed a quick fall of testosterone levels after start of therapy with~     Firmagon® and a quick recovery when therapy is stopped. The investigators want to prove this~     in a normal outpatient urologist setting. Furthermore data is collected to prove the~     adherence to the German S3-Guideline for the treatment of prostate cancer.~   "
141886|NCT01710085|"~     Endometrial and cervical cancers are one of the most common malignancies seen in females.~     Identification of recurrent disease in early phases of treatment carries a primary importance~     on the outcome of patients. Diffusion-weighted magnetic resonance imaging (DWI) is a new~     technique recently started to be performed in body imaging and has potential ability to~     detect recurrent disease. The aim of this study is to investigate the diagnostic impact of~     DWI in detection of recurrent disease in patients treated with curative surgery in~     endometrial and cervical cancer.~   "
141887|NCT01710072|"~     Hypothesis: aspirin attenuates inflammation in cerebral aneurysms and hence reduces the~     incidence of rupture. This effect can be monitored using the signal generated by macrophages~     (inflammatory biomarker) in ferumoxytol-enhanced MRI.~      Study aims:~      1. Determine if daily aspirin intake (for three months) would obliterate/reduce~     ferumoxytol-enhanced MRI signal changes generated by macrophages in cerebral aneurysm wall.~     Fifteen patients with cerebral aneurysms > 7 mm will be selected to enroll in this pilot~     study. 10 patients will be imaged at base line with ferumoxytol-enhanced MRI. Following that,~     they will take aspirin 81 mg daily and then re-imaged again at three months. This group will~     be compared to a control group of 5 patients where they will have the imagings studies~     performed at base line and at three months but will NOT take aspirin.~   "
141888|NCT01710059|"~     This study has two main goals. The first goal is to test whether a mobile phone intervention~     can increase adherence to daily inhaled steroid medications in African American adolescents~     prescribed this type of medication by his/her asthma doctor. The second goal is to use a~     mobile phone intervention to better understand real life patterns of use of quick-relief~     (beta2-adrenergic agonist) asthma medication in this population.~   "
141889|NCT01710046|"~     There are cells in the skin and blood of humans with chronic moderate to severe plaque~     psoriasis with specific activities that may determine the effectiveness of treatment. These~     activities may be described by obtaining samples of skin and blood and analyzing them using a~     variety of tests.~   "
141890|NCT01710033|"~     This was a Phase 1 dose escalation study to evaluate the safety, tolerability and~     pharmacokinetics of 28-day treatment of CP-690,550 in stable renal allograft recipients. In~     Stage 1, ascending doses of CP-690,550 were to be administered sequentially to 3-4 cohorts of~     subjects. After Stage 1, one dose level was to be selected for dosing in an expanded cohort~     in Stage 2.~   "
141891|NCT01710020|"~     There were 2 study periods in this study. In the Period 1, CP-690,550 was to be administered~     approximately 1 to 2 hours following hemodialysis. If significant non-renal clearance of the~     drug occurred such that dialyzability of CP-690,550 could not be assessed in Period 1, a~     second period (Period 2) will be conducted. In Period 2, a single dose of drug will be~     administered approximately 4 hours prior to hemodialysis.~   "
141892|NCT01710007|"~     1PC002 is a newly developed synthetic and highly potent HMG-CoA reductase inhibitor. Its~     active compound, pitavastatin has recently been approved by US FDA for indications of primary~     hypercholesterolemia and combined dyslipidaemia. It exhibits unique pharmacokinetic~     properties. Unlike atorvastatin which is metabolized by CYP3A4, metabolism of 1PC002 does not~     depend on CYP3A4. This multi-center study is conducted to confirm the efficacy and safety of~     1PC002 administered for 12 weeks is non-inferior to atorvastatin.~   "
141893|NCT01709994|"~     The objective of the study is to examine whether the use of low-dose aspirin (75-100 mg /~     day) reduces the risk of cardiovascular disease in patients with chronic kidney disease~     (stage 3 or 4).~   "
141894|NCT01709981|"~     Peri-procedural inflammation is associated with increased rates of post-procedural myocardial~     infarction (MI), which occur in up to 35% of PCI patients and are themselves associated with~     increased risk of later MI and death. Statins suppress both inflammatory markers and MI rates~     during and after PCI, but ≥ 40% of PCI patients go statin-untreated, due in part to side~     effects such as myalgia. Moreover, because their mechanism of action relies on~     post-translational effects, statins must be given ≥ 12 to 24 hours prior to PCI, a time frame~     that is not always feasible. The investigators propose a novel alternative approach to reduce~     inflammation during PCI employing colchicine, an anti-inflammatory medication used frequently~     in gout and pericarditis. Colchicine may be particularly applicable to the PCI setting due to~     its rapid onset of action and excellent side-effect profile at low doses, as well as its~     known mechanisms of action. However, data on colchicine use in patients with coronary disease~     is extremely limited, and no studies to date have evaluated the use of colchicine in patients~     undergoing PCI. The investigators aim to characterize a potential mechanism of benefit in~     patients undergoing PCI by evaluating the effects of colchicine on soluble and leukocyte~     surface markers after PCI. The investigators also aim to determine the effects of colchicine~     on peri-procedural myonecrosis and MI. Accordingly, the investigators propose a prospective~     randomized study to characterize the effect of colchicine on inflammation and peri-procedural~     myocnecrosis. Patients referred for possible PCI will be randomized in a double-blinded~     fashion to placebo or colchicine (1.2mg 1 to 2 hours before PCI, followed by 0.6mg 1 hour~     later). The primary endpoint will be post-procedural interleukin-6 level. Secondary endpoints~     will include other relevant soluble and leukocyte-associated inflammatory markers and rates~     of peri-procedural myonecrosis and MI. Sample size needed is 200 patients undergoing PCI. To~     adjust for a floor effect, 280 patients undergoing PCI will be needed. 400 patients will~     likely be needed to be enrolled to reach 280 PCIs (the remaining will have undergone a~     diagnostic only procedure).~   "
141895|NCT01709968|"~     Nocturnal leg cramps (NLC) are painful, involuntary contractions of muscles occurring at~     rest, mostly at night. A Cochrane review on leg cramps in pregnancy showed some potential~     benefits in trials of magnesium. This is a single center, prospective, randomized, double~     blind, placebo controlled clinical trial that aims to investigate the effect of treatment~     with Magnox 520® (un-organic granular magnesium complex, composed of Magnesium Oxide &~     Magnesium Oxide Monohydrate 865mg, Provides 520 mg of free elemental Mg++) on frequency and~     severity of NLC, quality of sleep and quality of life. Hypothesis: Magnox 520® may reduce the~     number and severity of NLC; an improvement in the quality of life and quality of sleep may~     ensue.~   "
141896|NCT01709955|"~     The purpose of this study is to determine if the herb, Glucomannan, is an effective~     non-pharmacological appetite suppressant for overweight or Class I obese patients. The study~     design will not include any other lifestyle changes which enhance weight loss in order to~     completely isolate the effects of Glucomannan as a non-pharmacological appetite suppressant.~   "
141897|NCT01709942|"~     In this study the effectiveness of degarelix, a long acting GnRH antagonist administered in a~     unique administration of 20 mg the first day of menstrual cycle, to prevent ovarian~     hyperstimulation syndrome (OHSS) in PCOS women at risk to develop OHSS.~   "
141898|NCT01709929|"~     This trial is conducted in North America. The aim of this trial is to evaluate the safety of~     insulin detemir for the treatment of diabetes.~   "
141899|NCT01709916|"~     Glaucoma is one of the leading causes of blindness in the west. The disease caused by high~     intra ocular pressure (IOP) and characterized by damage to the optic nerve and gradual loss~     of visual field. Intra ocular pressure change during the day. To evaluate the efficiency of~     the therapy it is common to measure the intra ocular pressure at different times of the day.~     Most ophthalmologists admit the patient for one day at which intra ocular pressure is~     measured at different times. This method does not mimic the patient daily routine and may not~     reflect the true diurnal fluctuations.~      For this reason some ophthalmologists measure the intra ocular pressure at different times~     and at different days. It is not known if both methods give similar diurnal curves.~   "
141900|NCT01709903|"~     To demonstrate the non-inferiority of QVA149 110/50 µg o.d. to fluticasone/salmeterol 500/50~     µg b.i.d. in terms of trough Forced Expiratory Volume in one second (FEV1) (mean of 23 hours~     15 min and 23 hours 45 min post QVA149 dose) following 26 weeks of treatment in patients with~     moderate to severe COPD~   "
141901|NCT01709890|"~     Patients under sedation not uncommonly develop upper airway obstruction or other respiratory~     complications and no airway device is available to provide reliable maintenance of the airway~     at present. I believe the YO2(R)airway catheter can improve the maintenance of patent airway~     in most sedated patients and improve O2 delivery to the airway. In addition it may also~     greatly facilitate the monitoring of expired CO2, which is widely recognised as the most~     important monitor of adequacy of breathing, yet frequently impossible to perform~     satisfactorily in sedated patients at the moment.~   "
141902|NCT01709877|"~     Its main objective is to evaluate the clinical outcome (including patient reported outcomes)~     and health economic assessment (HTA) of a new re-usable system for Single Port Laparoscopic~     Surgery - ENDOCONE SYSTEM developed by Prof Cuschieri by undertaking a randomised controlled~     prospective clinical trial (RCT) on specific operations performed (on a random allocation~     basis) by either the traditional multi-port laparoscopic approach or the Single Port-~     ENDOCONE system by Karl Storz. To this effect, 300 patients meeting the trial inclusion~     criteria will be randomised over a three year period to have the operation by either of the~     two approaches.~   "
141903|NCT01709864|"~     The study serves to determine whether the treatment of patients with stable, symptomatic~     Chronic Obstructive Pulmonary Disease (COPD) with the investigational drug NVA237 is~     efficient and safe. The efficacy and safety of the drug will be tested against a placebo~     treatment.~      The primary criterion to assess efficacy will be the difference between the serial lung~     function measurements of patients who have been treated for 12 weeks with NVA237 versus those~     that have received placebo treatment for 12 weeks. A serial lung function measurement (FEV1~     testing) will be conducted and the area under the curve will be the measure for the ability~     to breathe.~   "
141904|NCT01709851|"~     Over the last years, a number of systems for continuous subcutaneous glucose monitoring have~     been marketed and are routinely used in patients with diabetes to obtain more detailed~     information about 24-hour glucose profiles.~      In the hospital, numerous factors influencing glycemic control and possibly leading to~     glucose excursions out of the desired range exist, e.g. interventions for which the patient~     has to remain fasting or medications such as corticosteroids or vasopressors. A reliable~     continuous glucose signal could help to observe levels of glycaemia not only at defined~     time-points but continuously, making it possible for physicians and nursing staff to better~     adjust antihyperglycemic therapy and to react before the patient is exposed to severe hypo-~     or hyperglycaemia.~      In the hospital setting, vascular access is granted in the majority of patients and could as~     well be used as an alternative site for continuous glucose monitoring.~      The aim of the present study is to assess accuracy of the glucose data obtained by means of~     an intravascular microdialysis-based CGM system against venous blood glucose reference~     measurements.~   "
141905|NCT01709838|"~     To assess the efficacy of deferasirox in patients with non-transfusion dependent thalassemia~     based on change in liver iron concentration from baseline after 52 weeks of treatment. To~     provide further assessment of the long-term efficacy and safety of deferasirox in NTDT~     patients with iron overload (LIC ≥ 5 mg Fe/g liver dw and SF ≥ 300 ng/mL) for up to 260~     weeks.~   "
141906|NCT01709825|"~     The purpose of this study is to determine if daily consumption of a probiotic in the period~     before, during and after academic exams will help maintain digestive and immune health and~     quality of life of undergraduate students.~   "
141907|NCT01709812|"~     A 6 months prospective, randomized, multicenter, controlled, parallel-group, open-label study~     in RRMS patients to assess the impact of an individualized patient support program (PSP) on~     treatment satisfaction and to evaluate whether this individualized support improves~     satisfaction and with it adherence to medication compared to standard care.~   "
141949|NCT01709266|"~     Background:~      The incidence of gastrointestinal infections is very high. In Western countries at least 30%~     of the population suffers from at least one food-borne infection per year. Mostly because of~     the problem of antibiotic resistance, more emphasis is put on prevention of infections. One~     of the possibilities is to strengthen human resistance to gut infections by consumption of~     probiotics. A specific blend of probiotic lactic acid bacteria (Lactobacillus helveticus~     Rosell-52, Lactobacillus rhamnosus Rosell-11, Bifidobacterium longum Rosell-175) and a~     probiotic yeast (Saccharomyces boulardii), improved stool consistency and shortened the~     duration of diarrhea in a rat model of E.coli-induced diarrhea. These probiotics showed~     synergistic effects compared with administration of solely S. boulardii or a mixture of L.~     helveticus Rosell-52, L. rhamnosus Rosell-11, B. longum Rosell-175. Consumption of S.~     boulardii and a combination of L. helveticus Rosell-52, L. rhamnosus Rosell-11 reduced~     diarrhea in humans.~      Aim:~      To study whether probiotics improves the resistance of humans to enterotoxigenic E. coli~     (ETEC).~      Study design:~      The PROTETEC study is a parallel, double-blind, placebo-controlled 4-weeks intervention with~     probiotics in healthy volunteers. In this study, the effect of probiotic intervention vs~     placebo on several infection markers in response to an ETEC challenge is investigated.~     Participants will be randomly assigned to the probiotic or placebo group (n=30 per group).~     Subjects will be instructed to maintain their usual pattern of physical activity and their~     habitual food intake, but to standardize their dietary calcium intake. After an adaptation~     period of 2 weeks, subjects will be orally infected with a live, but attenuated, ETEC vaccine~     (strain E1392-75-2A; collection NIZO food research; dose 10E10 CFU). Before and after~     infection, a diary will be kept to record all food and drinks consumption (2x2 days) to~     assess the habitual dietary intake, as well as for daily recording of bowel habits and~     frequency and severity of gastrointestinal complaints. The following biological samples will~     be collected: 4x10 ml venous blood, a single fecal bolus (for screening) and 7x24 hrs feces.~     Blood is sampled for immune response analyses and the fecal samples are collected to quantify~     several infection- and immune system markers, to determine probiotic excretion, and to verify~     dietary calcium intake.~      Study population:~      Healthy males of 20-55 yrs of age.~      Interventions:~      Probiotics (capsules containing freeze-dried powder, probiotic dose per capsule 5x10E9 CFU;~     twice daily) or placebo (capsules with carrier material powder of identical appearance)~      Primary outcomes:~      Fecal ETEC excretion and severity of diarrhea (quantified by fecal output per day).~      Secondary outcomes:~      Serum immune response to ETEC, self-reported stool consistency scores and gastrointestinal~     complaints, relative fecal wet weight.~      Tertiary outcomes:~      sIgA and calprotectin in feces, probiotic persistence and levels of opportunistic pathogens~     in the endogenous microbiota.~   "
141950|NCT01709253|"~     Phase 2 hypofractionation study usion proton beam therapy for prostate adenocarcinoma~   "
141908|NCT01709799|"~     The purpose of this research study is to help scientists and health care providers learn more~     about preventing dementia and brain disease in older adults. There is an urgent need to~     develop strategies to prevent or slow down memory loss and brain function decline in the~     elderly.~      In this study, the investigators hope to learn how physical exercise and a brain training~     program work together to improve thinking and memory in older adults. Specifically, these~     aims include:~        -  Learning whether physical activities (like biking or treadmill walking or Wii Fit games)~          will help improve the benefits of a brain training program. Based on preliminary results~          and that in the literature, the investigators anticipate greater cognitive benefits in~          the Exercise + Cognitive training groups than the Cognitive Training alone group.~        -  To determine whether the benefits of adding exercise will occur quickly or develop more~          gradually over time. The investigators suspect that a major benefit of exercise~          pre-dosing will occur by the 12th week of the program.~        -  To examine whether Wii-Fit exercise games cause similar effects on brain training as~          traditional exercise programs such as biking or walking. Although several recent studies~          have raised questions about the true aerobic benefit of exergames such as Wii-Fit Plus,~          other evidence suggests that these weaker aerobic benefits may be offset by the greater~          novelty and interest level afforded by exergames.~   "
141909|NCT01709786|"~     This study will evaluate the accuracy of two rapid methods of measuring hemoglobin in~     patients with suspected hemorrhage. These methods will be compared with standard laboratory~     measurements.~   "
141910|NCT01709773|"~     This is a pilot cohort study of women undergoing focal ablation for high-grade cervical~     intraepithelial neoplasia (HGCIN). The cohort was recruited from the UCSF Dysplasia Clinics.~     The standard treatment involves treatment of the entire cervix. Women with HGCIN meeting~     inclusion criteria were recruited for enrollment into the pilot study of focal treatment.~     Upon enrollment, they underwent focal ablational treatment rather than standard ablational~     treatment of the cervix. Follow-up visits were conducted at 2 weeks and 6 months to assess~     safety, feasibility, and acceptability. The 6-month recurrence rate of HGCIN will be~     calculated.~   "
141911|NCT01709760|"~     A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre,~     Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination with~     Methotrexate versus Methotrexate Alone in Patients with Rheumatoid Arthritis~   "
141912|NCT01709747|"~     The purpose of this study is to evaluate the long-term safety of hydromorphone hydrochloride~     administered by intrathecal delivery.~   "
141913|NCT01709734|"~     A Phase 2, 2 part trial to evaluate the safety and efficacy of galeterone in castration~     resistant prostate cancer (CRPC) patients.~   "
141914|NCT01709721|"~     The purpose of this study is to determine the safety and efficacy of hydromorphone~     hydrochloride by intrathecal administration using a programmable implantable pump.~   "
141915|NCT01709708|"~     Migraine imposes a substantial burden on patients in terms of diminished daily functioning,~     quality of life, and financial loss. Pain severity and duration correlates with reduced~     measures of daily functioning, and overall health status. The sphenopalatine ganglion (SPG)~     has been implicated in a variety of cephalalgias. This has been well represented in the~     literature dating back over a century. Access to this structure can be gained via a small~     area of mucosa just posterior and superior to the tail of the middle turbinate on the lateral~     nasal wall. At this aspect, there is no bony boundary to the SPG. Blocking the SPG using~     local anesthetics relieves pain. Unfortunately, many current interventions are cumbersome,~     invasive, and expensive. The purpose of this study is to evaluate the efficacy of the Tx360™,~     a new nasal applicator device, in the treatment of head and face pain and to examine the~     economic implications. The Tx360™ is a single use device designed to deliver a topical local~     anesthetic to the specific area of mucosa associated with the SPG. A total of 42 study~     participants will be accepted into this double-blind placebo-controlled study. 28 will~     receive SPG blocks using a 0.3 mL of a 0.5% solution of Marcaine delivered by the Tx360™~     while 14 will receive a placebo of saline substituted for the Marcaine. Both patient sets~     will also be given a piece of lemon hard candy as a taste distractor. Participants must have~     a chronic migraine history with over 15 symptomatic days per month over the past three~     months. The treatment plan consists of six weeks of treatment, two times per week. Short and~     longer term assessments will be retrieved and analyzed as detailed in the Study Design.~   "
141916|NCT01709695|"~     This study proposes to evaluate the effects of guanfacine extended release on brain~     activation during fMRI in children and adolescents with ADHD between the ages 8-15 and ADHD~     subjects randomized to placebo treatment.~      This study also proposes to collect DNA on study participants, to examine the genetic~     underpinning of the observed fMRI activation profiles at baseline and in response to~     treatment. The purpose is to examine polymorphisms of the adrenergic 2A gene (and other~     related targets) for genetic biomarkers in association with the fMRI findings of this study.~   "
141917|NCT01709682|"~     The hypothesis of this study was that early re-ablation (test) was superior to AAD therapy~     (control) in patients with previous failed PVI ablation for paroxysmal AF.~   "
141918|NCT01709669|"~     Overall, the investigators aim to recruit 150 subjects during their hospitalization for an~     acute coronary syndrome (ACS). At two weeks post-ACS, the investigators will assess levels of~     gratitude and optimism, draw blood for baseline levels of biomarkers, gather baseline~     information about health behaviors critical to cardiac health, and obtain baseline measures~     of symptoms and function. Finally, the investigators will repeat assessments of biomarkers,~     behavior, and function at 6 months to allow us to assess the impact of gratitude and optimism~     on these outcomes; the investigators will also have an objective measure of physical activity~     via accelerometer (step counter) at 6 months.~      Specific Aim #1: To prospectively assess the association between gratitude/optimism 2 weeks~     after ACS and improvement in biological markers of cardiac health at 6 months post-ACS.~      Hypothesis: Higher levels of gratitude/optimism at 2 weeks will be associated with greater~     reductions in levels of biomarkers associated with negative heart health between 2 weeks and~     6 months.~      Specific Aim #2 (*primary aim*): To assess the association between gratitude/optimism 2 weeks~     after ACS and subsequent adherence to health behaviors known to improve post-ACS prognosis at~     6 months.~      Hypothesis: Higher levels of gratitude/optimism at 2 weeks will be associated with greater~     amounts of physical activity (measured by accelerometer) at 6 months (primary study outcome~     measure), and greater improvements in self-reported adherence to health behaviors (activity,~     diet, and medication) between 2 weeks and 6 months.~      Specific Aim #3: To assess the association between gratitude/optimism at 2 weeks and~     non-elective cardiac rehospitalizations (and other clinical outcomes) at 6 months.~      Hypothesis: Higher levels of gratitude/optimism at 2 weeks will be associated with greater~     improvements in depression, health-related quality of life, function, cardiac symptoms, and~     possibly readmissions, between 2 weeks and 6 months.~   "
141919|NCT01709656|"~     The investigators will recruit active ankylosing spondylitis patients for injection treatment~     of Human Mesenchymal Stem Cells (a prospective, open-label, masculine medicine~     controlled(NSAIDs), clinical trial), and collect their Peripheral Blood Lymphocyte (PBMCs)~     and sera before and after the treatment of 24 weeks to test the gene expression profiles and~     study related pathogenesis of AS~   "
141922|NCT01709617|"~     Carbohydrates are an integral component of sports nutrition. Providing carbohydrate (CHO)~     during exercise delays the onset of fatigue and improves exercise performance by maintaining~     high rates of CHO oxidation. Traditionally, glucose, or glucose polymers have been the~     preferential CHO source found in sports drinks. However, during the intestinal absorption of~     large amounts of glucose (>1.2 g/min), sodium-dependent glucose transporters (SGLT1) may~     become fully saturated, potentially limiting the rate of exogenous CHO oxidation. In an~     effort to evade this limitation, research has suggested using multiple transportable~     carbohydrates in the composition of sports drinks. Multiple transportable carbohydrates are~     combinations of simple sugars that use different intestinal transporters during the~     absorption process. Ingesting multiple transportable carbohydrates may enhance the capacity~     for total intestinal CHO absorption, leading to an increase in the rate of exogenous CHO~     oxidation. Our purpose will be to examine the disaccharide sucrose in it's ability to provide~     exogenous fuel during and following prolonged exercise.~   "
141923|NCT01709604|"~     Paraquat poisoning is characterized by multiple organ failure and pulmonary fibrosis with~     respiratory failure. Accumulating evidence suggested that continuous venovenous~     hemofiltration (CVVH) had a beneficial role in the treatment of multiple organ dysfunction.~     The investigators hypothesized that CVVH might restore multiple organ function and reduce the~     high mortality rate of paraquat poisoning. To confirm it, an prospective clinical study would~     be carried out.~   "
141924|NCT01709591|"~     The purpose of the study is to determine if targeted prenatal educational program on womens'~     perceptions of epidural increases the acceptance of intrapartum epidural analgesia relative~     to the control group.~   "
141925|NCT01709578|"~     Primary Objective:~      To demonstrate that sarilumab added to disease modifying anti-rheumatic drugs (DMARDs) were~     effective for:~        -  reduction of signs and symptoms at Week 24 and~        -  improvement of physical function at Week 12~      in participants with active rheumatoid arthritis (RA) who were inadequate responders or~     intolerant to tumor necrosis factor alpha (TNF-α) antagonists.~      Secondary Objectives:~      The secondary objectives were to investigate the effects of SAR153191 (REGN88) when added to~     DMARD therapy, in participants with active RA who were inadequate responders or intolerant to~     TNF-α antagonists, for:~        -  Reduction of signs and symptoms at Week 12;~        -  Improvement in physical function at Week 24;~        -  Improvement in disease activity score as measured by other American College of~          Rheumatology (ACR) derived components at Weeks 12 and 24;~        -  Improvement in quality of life as measured by participant reported outcomes (PROs) at~          intermediate visits and Week 24.~      To assess the exposure of sarilumab added to DMARD therapy in this population.~      To assess the safety of sarilumab in this population.~   "
141926|NCT01709565|"~     The purpose of this study is to compare lactate clearance in patients with severe sepsis and~     septic shock according to the presence of hepatic dysfunction.~   "
141927|NCT01709552|"~     The purpose of this study is to target co-occurring problems of substance use and intimate~     partner violence (IPV) using a computer-based intervention, B-SAFER (Brief intervention for~     Substance use and partner Abuse for Females in the Emergency Room). This project will develop~     and test the computer-based intervention, examining primary outcomes of substance use and~     utilization of relationship safety resources.~   "
141928|NCT01709539|"~     The aim of this study is to evaluate a new cancer diagnosis center (Diagnostiskt Centrum, DC)~     in Kristianstad, Sweden. Patients aged ≥ 18 years who are suspected of having serious illness~     but who have no organ-specific symptoms will be referred to the DC for further investigation~     after preliminary assessment in primary care. The overall purpose of the study is to evaluate~     whether the DC meets its target time for diagnosing cancer. In addition, we will evaluate~     secondary issues, such as survival, to determine whether this pilot project merits extension~     to other parts of southern Sweden.~   "
141929|NCT01709526|"~     The aims of this six month follow-up study are which treatment components will correlate or~     which clinical treatments interventions contribute adolescent inpatients recovering in the~     psychiatric treatment after discharge. Comparisons will be made between the 47 adolescents~     aged 13 to 18 years, with major depression and conduct disorders, and between those with and~     without suicide attempts by multivariate analyses. Are the adolescent psychiatric inpatients~     recovered?~   "
141930|NCT01709513|"~     This is a randomized, double-blind, double-dummy, active-controlled, parallel-group,~     multi-national, multi-center study to compare alirocumab (REGN727/SAR236553) versus ezetimibe~     in participants with primary hypercholesterolemia and moderate, high, or very high CV risk,~     who are intolerant to statins. An atorvastatin arm is added to determine that the population~     selected in the study is a truly statin intolerant population by assessing skeletal~     muscle-related adverse events.~   "
141931|NCT01709500|"~     This is a randomized, double-blind, placebo-controlled, parallel-group, multi-national study~     alirocumab (REGN727/SAR236553) in patients with Heterozygous Familial Hypercholesterolemia~     (heFH) who are not adequately controlled with their Lipid-Modifying Therapy (LMT).~   "
141932|NCT01709487|"~     First line treatment for advanced ovarian carcinoma hyperthermic intraperitoneal chemotherapy~     (HIPEC) after optimal debulking.~   "
141933|NCT01709474|"~     The primary objective of this study is to evaluate the effects of 18 weeks of high-dose~     vitamin D3 supplementation compared with standard-dose vitamin D3 supplementation on immune~     function, glucose homeostasis, and bone metabolism in children with systemic lupus~     erythematosus (SLE) and serum 25-hydroxyvitamin D [25(OH)D] levels ≤20 ng/mL.~   "
141934|NCT01709461|"~     the purpose of the study is to extend the use of Rasagelin Mesylate 1mg per day by subjects~     who participated in the Adagio TVP 1012/501 according to form 4a for additional three years.~   "
141935|NCT01709448|"~     The purpose of this study is to determine whether a model can be created to predict the~     progression of early anal cancer precursor lesions in HIV using potential predictors such as:~     HIV treatment history, smoking history, sexual history, human papillomavirus viral load,~     human papillomavirus protein expression, and cell markers associated with progression of~     HPV-related lesions.~   "
141936|NCT01709435|"~     This phase I trial studies the side effects and best dose of cabozantinib S-malate in~     treating younger patients with solid tumors that have come back or no longer respond to~     treatment. Cabozantinib S-malate may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth.~   "
141938|NCT01709409|"~     The purpose of this study is to see if a medication called Curosurf can reduce the length of~     time that small premature babies with Respiratory Distress Syndrome (immature lungs) or RDS,~     stay on the ventilator, as compared to the standard medication called BLES. Curosurf is a~     medication that is already used in other countries around the world but not yet in Canada.~      Babies born under 32 weeks of gestation frequently need respiratory support after birth,~     including being placed on a breathing machine or respirator. The most common reason is~     Respiratory Distress Syndrome (RDS) whereby immature lungs don't produce enough surfactant, a~     soapy like substance that helps the air sacs open and close. Our current standard treatment~     is a surfactant called BLES. Curosurf contains more active ingredient per volume therefore~     the amount is smaller. The investigators hypothesize that babies who receive Curosurf will be~     able to be removed from the ventilator sooner.~      Babies in this study will have a 50/50 chance of receiving either Curosurf or BLES and the~     investigators will monitor their progress during their Neonatal Intensive Care Unit~     admission.~      The study is taking place in Canada. The goal is to enroll 88 babies. There are no extra~     tests (blood tests or X-Rays) or return visits to the hospital for the purposes of this~     study.~   "
141939|NCT01709396|"~     Acute myeloid leukemia (AML) is a rapidly fatal malignancy of the bone marrow. It can be~     treated with chemotherapy alone, in some cases, but in the majority of cases, the only~     treatment that can cure the disease is an allogeneic stem cell transplant, with a cure rate~     of 30-40%. In another subset, the disease is less responsive to chemotherapy and in these~     aggressive forms, its cure rate is no better than 20% beyond 2 years, and is usually rapidly~     fatal within 6 months.~      Therefore, for this most aggressive form of the disease, modifications to the transplant~     protocol are required in order to try to improve on these poor results. There are a number of~     areas within the transplant protocol on which modifications can be made in order to achieve~     these goals. These include: higher doses of chemotherapy and or radiation; alterations of the~     new bone marrow graft; and alterations of the immune suppression, enhancing the graft vs.~     leukemia effect. By focusing on one or more of these components, one might be able to enhance~     the anti-leukemic aspect of the treatment resulting in a more successful outcome.~      One aspect the investigators, in Ottawa, have focused on is the initial intensive~     conditioning regimen, specifically the radiation component. It is the investigators belief~     that in the most resistant disease it is important to use the highest tolerable anti-leukemic~     treatment upfront, specifically, enhancing the radiation component of the initial~     conditioning regimen. Previous studies have suggested that higher doses of radiation might be~     more effective at eliminating the disease, however, toxicity and logistics of delivering the~     radiation have limited its use. Technical advances in the delivery of radiation have now~     permitted the safer use of high doses of radiation.~      Through modifications to the transplant procedure, the investigators believe that they can~     deliver higher doses of radiation safely and this will translate into improved outcomes in~     this high-risk subgroup of patients with AML.~      Study Objectives~      The goal of this study is to determine if a total dose of 18Gy ED-TBI followed by an alloHSCT~     for patients with refractory AML will result in an improved progression-free survival.~   "
141940|NCT01709383|"~     This study tests whether weak electrical stimulation of the brain is effective in improving~     language or reading difficulties occurring after a brain injury or stroke.~   "
141941|NCT01709370|"~     This is a phase II study evaluating the efficacy and safety of the pre-operative use of~     letrozole plus PD 0332991 (combination therapy)~   "
141942|NCT01709357|"~     The purpose of this study was to investigate the short and medium-term effects of three~     manual techniques on cervical range of motion and pressure pain sensitivity in subjects with~     mechanical stress, presenting latent trigger point of upper trapezius muscle.~   "
141943|NCT01709344|"~     Older adults who are treated for cancer are at risk of developing disabilities due to the~     symptoms of cancer and the side effects of treatment. Disability occurs when a person has~     trouble performing the activities he or she needs to do in everyday life. For example,~     fatigue and pain can make it difficult for an older adult to do housework, leisure, or~     volunteer activities. Disability makes it harder for older adults to stay active and be~     productive members of the community, and it can increase the costs of healthcare.~      Current approaches to cancer rehabilitation focus on using exercise, education, and social~     support to reduce cancer treatment side effects. These are important strategies to reduce~     disability, yet some side effects persist despite best efforts to resolve them. To fully~     reduce disability, people often need to adapt their activities or the environments in which~     they are performed.~      The goal of this study is to test an occupational therapy (OT) intervention that teaches~     activity planning skills to foster survivors' ability to adapt activities, routines, and~     environments in order to minimize disability. The project targets adults over the age of 65~     who are experiencing disability during or after cancer treatment. The project has two stages.~     First, twelve older adult cancer survivors will individually participate in the~     community-based intervention. After they have completed the program the investigators will~     revise the intervention to emphasize what they found most effective and helpful, and to~     eliminate aspects of the intervention that are perceived as unhelpful or redundant. The~     research question for this first stage of the project is, To what degree is it feasible for~     survivors to enroll in the study, complete the six-week intervention, and complete the three~     outcome assessments? In the second stage of the project, the investigators will test the~     revised intervention, comparing it to conventional care. The research question for the second~     stage of the project is, Do the people receiving the intervention have higher activity~     levels, greater behavioral activation, lower levels of disability, and better quality of life~     compared to those people who receive traditional cancer care? The intervention is~     appropriate for people who have been diagnosed with any type of cancer. It is designed to~     focus on whatever activities are most important to each participant. The novelty of the~     proposed intervention lies in the combination of the OT strategies of activity and~     environmental adaptation with explicit training in activity planning to teach survivors to~     find creative ways to engage in valued activities (e.g., taking care of one's home and family~     members, and participating in leisure, community, social and work activities). If the~     intervention is effective in reducing disability, it will give us another tool to reduce the~     impact of cancer on the daily lives of cancer survivors.~   "
141944|NCT01709331|"~     This study will assess if corifollitropin alfa (MK-8962), when administered in combination~     with human chorionic gonadotropin (hCG), will increase testicular volume in men with HH who~     remain azoospermic after treatment with hCG alone.~      Hypothesis: The lower limit of the 95% confidence interval for the geometric mean increase in~     testicular volume from Day 1 to Week 52 is greater than one.~   "
141945|NCT01709318|"~     The study is designed to the evaluate ovulation inhibition, vaginal bleeding, and~     pharmacokinetics associated with three different doses of two next generation vaginal rings~     (NGRs), identifying at least one whose control of menstrual cycles is not inferior to that of~     NuvaRing®.~   "
141946|NCT01709305|"~     To assess the effect of adding acarbose or repaglinide or gliclazide to sitagliptin plus~     metformin, compared to adding glimepiride, on glycemic improvements in Type 2 Diabetes~     Mellitus (T2DM) participants who require the addition of a third oral anti-hyperglycemic~     agent (OAHA) according to China Guideline for Type 2 Diabetes. The three co-primary~     hypotheses are that after 24 weeks of treatment in phase 2, the mean change from baseline in~     hemoglobin A1c (A1c) in participants receiving either (1)acarbose or (2)repaglinide or~     (3)gliclazide added to sitagliptin and metformin combination is non-inferior to that of~     participants receiving glimepiride added to sitagliptin and metformin combination. The study~     would be declared successful if at least one of the three primary hypotheses was met.~   "
141947|NCT01709292|"~     The goal of this clinical research study is to learn about how vemurafenib may affect certain~     biomarkers in patients with PTC. Biomarkers are in the blood/tissue and may be related to~     your reaction to the study drug. The safety of this drug will also be studied.~      Vemurafenib is designed to block the BRAF gene mutation. This mutation causes cancer and~     cancer growth. By blocking this mutation, the drug may kill the cancer cells with the~     mutation and/or stop the tumor from growing.~   "
141952|NCT01709227|"~     Acute kidney injury (AKI) after cardiopulmonary bypass (CPB) in infants is common and~     associated with poor outcomes. Peritoneal dialysis (PD) and furosemide have been used to~     attain negative fluid balance due to AKI induced oliguria, but have not been compared~     prospectively. The investigators will prospectively compare outcomes of infants with oliguria~     after CPB randomized to PD vs. furosemide with the hypothesis that infants receiving PD have~     superior outcomes.~   "
141953|NCT01709214|"~     The purpose of this study is to evaluate the safety and efficacy of GRT6005 compared to~     placebo in patients with moderate to severe chronic pain due to osteoarthritis (OA) of the~     knee. This study includes a maximum 21 day Screening Period followed by a 15-week~     Double-blind Treatment Period and a 4-7 day Safety Follow-up period. Patients who are~     eligible for the Double-blind Treatment Period will be randomized to one of following~     treatment groups: GRT6005 high-dose range (400, 600 or 800 mcg), GRT6005 low-dose range (200,~     300 or 400 mcg), oxycodone CR (Controlled Release) dose range (10, 20, 30, 40 or 50 mg) or~     placebo.~   "
141954|NCT01709201|"~     The investigators goal is to pilot a substance use-related brief intervention (BI) for youth~     with chronic medical conditions, obtaining preliminary evidence of feasibility, acceptability~     and impacts of the approach for reducing substance use among this group.~   "
141955|NCT01709188|"~     The purpose of this project is to determine if the Musical Dual Task Training program~     improves attention control that influences measures of gait performances under dual tasking,~     balance, fear of falling, and behavioral disturbance in patients with mild to moderate~     dementia. This Musical Dual Task Training protocol is structured with musical content and~     patients are required to do musical tasks including singing and playing instruments~     contingent on visual or auditory cues while walking. This paradigm is designed to include~     music making because it involves great demands on attention and memory that might elicit~     experience-dependent plasticity in the brain. Musical Dual Task Training is proposed to~     strengthen brain networking for attention control that consequently may improve the gait~     performances in patients with dementia, as indicated by reducing dual task cost on gait.~   "
141956|NCT01709175|"~     The purpose of this study is to compare once-a-week vs. twice-a-week strength training in~     survivors of breast and gynecologic cancer to determine which is the optimal exercise~     prescription.~   "
141957|NCT01709162|"~     The purpose of the study is to determine whether additional doses of ipilimumab have a~     positive effect on survival in the treatment of advanced melanoma that has progressed after~     successful initial treatment with ipilimumab.~   "
141958|NCT01709149|"~     The purpose of this research study is to evaluate the safety and effectiveness of CK-2017357~     when taken with or without riluzole (also called Rilutek®) in patients with Amyotrophic~     Lateral Sclerosis (ALS).~   "
141959|NCT01709136|"~     Pharmacokinetics of Tacrolimus and Sirolimus alone and in combination in liver transplant~     recipients.~   "
141960|NCT01709123|"~     6-8% of USA population has diabetes. Intensive blood glucose control dramatically reduces the~     devastating complications that result from poorly controlled diabetes. However, for many~     patients, achievement of tight glucose control is difficult with current regimens. Trivalent~     chromium, the form found in foods and dietary supplements, is believed to be safe. Our~     preliminary studies have reported that chromium supplementation inhibits the increase in~     pro-inflammatory cytokines (tumor necrosis factor-alpha and interleukin-6; TNF-alpha and~     IL-6) secretion levels caused by high glucose levels in cultured monocytic cells. Similarly,~     animal studies have shown that chromium niacinate supplementation lowered blood levels of~     glycemia and pro-inflammatory cytokines in streptozotocin-treated diabetic rats. Cytokines~     are proteins that are secreted by monocytes and other cells in response to various stimuli,~     such as infection. Some of the cytokines are known to regulate insulin sensitivity and~     elevated level of these cytokines in blood may accelerate clogging of arteries. Thus,~     chromium supplementation may increase insulin sensitivity and glycemic control in diabetic~     patients, and may prevent the development of cardiovascular disease in diabetic patients.~     Given the enormous public health cost of diabetes, the prospect of being able to use a~     relatively low-cost dietary supplement, such as chromium, as an adjuvant therapy to help in~     achieving normal blood glucose level merits further study.~      We will examine the effects of placebo and chromium niacinate supplementation on the fasting~     glucose, cholesterol, triglycerides, and markers of vascular disease in blood of diabetic~     patients. We will determine these above parameters at baseline and after the 1, 2 and 3~     months of supplementation in diabetic patients. The long-term objective is to explore the~     efficacy of chromium as an adjuvant treatment for better glycemic control, prevent the~     development of cardiovascular disease (CVD), and improve the life expectancy in diabetic~     population.~      Chromium supplements are widely used by the public and are available in many stores, such as~     Wal-mart, Walgreens, and many other food and drug stores. Chromium is an essential trace~     metal and micronutrient present in wide variety of vegetables. Niacin is a vitamin B6, an~     essential vitamin for our body. This study plans to use chromium niacinate, a complex of~     chromium and niacin. Chromium niacinate is considered a nutrient.~   "
141961|NCT01709110|"~     The primary purpose of participation in this study is to answer whether teriparatide is~     superior to risedronate in reducing the occurrence of new vertebral fractures during 24~     months of therapy.~   "
141962|NCT01709097|"~     Background:~      Adherence to the immunosuppressive drug regimen is critical to the outcome after an organ~     transplant. Patients need to take their prescribed medications and attend their appointments~     with the doctor.~      Based on previous studies in other European countries, the cost of non-compliance after organ~     transplantation in Sweden is >SEK 35 million/year.~      Patients who lose their graft both lose quality of life and have decreased expected survival;~     moreover, retransplantation may be hampered by new HLA antibodies.~      Question:~      The primary question is whether Med-O-Wheel™ can improve compliance to the prescribed~     medication regimen in renal transplant patients.~      Methods and materials:~      All kidney transplant patients at Karolinska University Hospital, Huddinge, will be given~     information about the study and will then be asked to participate. Participants will be~     randomized into two arms, one arm with and one with out Med-O-Wheel™. The 80 included~     patients will be closely monitored for 1 year regarding intake of prescribed medications.~      Med-O-Wheel™ is an electronic medication dispenser that records the date and time of each~     occasion when the patient takes medications from the dispenser. It has a SIM card and text~     messaging capabilities.~      Addoz Portal™ is a web-based application that makes it possible to monitor and analyse~     medication intake. Each event in the medication dispenser is registered in the portal, which~     communicates with the care provider/support person by text message, e-mail or telephone.~      Significance of the study:~      In the future it may be possible to improve compliance in transplant patients. In particular,~     patients will feel secure since they will receive confirmation through the portal that they~     are taking their medications safely and accurately.~   "
141963|NCT01709084|"~     The purpose of this study is to demonstrate noninferiority (a new treatment is equivalent to~     standard treatment) in terms of the percentage of patients who have plasma human~     immunodeficiency virus-type 1 (HIV-1) ribonucleic acid (RNA) levels less than 400 copies per~     mL after 48 weeks of randomized treatment with tenofovir disoproxil~     fumarate/emtricitabine/rilpivirine (TDF/FTC/RPV) versus TDF/FTC/efavirenz (TDF/FTC/EFV).~   "
141964|NCT01709071|"~     A new inactivated polio vaccine based on attenuated poliovirus strains was developed to~     transfer the technology to manufacturers in low- and middle-income countries. This vaccine~     was produced in different dosages and in different formulations. In healthy adults the safety~     of the highest dose was comparable to that of the existing inactivated polio vaccine. The~     purpose of this trial is to determine the safety of the different dosages and formulations of~     the vaccine in infants. The second goal of this study is to analyse the immune response after~     three doses in infants.~   "
141965|NCT01709058|"~     This study aims to evaluate the efficacy of the oxygen-ozone therapy in the treatment of back~     pain in subjects aged 65 or older. In particular, the intramuscular injection~     technique/paravertebral of oxygen-ozone mixture, a minimal invasive treatment with respect to~     intradiscal infiltration/intraforaminal technique, will be used.~   "
141966|NCT01709045|"~     The possibility to identify the risk of rupture of a carotid plaque will have tremendous~     impact in clinical decision making. A vulnerable plaque is considered to have a large lipid~     rich necrotic core (LRNC), a thin fibrous cap, the presence of inflammatory cells,~     intraplaque haemorrhage and/or neovascularisation (vasa vasorum). The investigators aim to~     validate imaging of plaque vulnerability with histology. Previous studies have evaluated the~     use of imaging to assess carotid plaque vulnerability, mostly showing a good correlation~     between imaging and histology and/or clinical characteristics. However, they have focused on~     single modalities, (magnetic resonance imaging [MRI], multidetector-row computed tomography~     (MDCT), ultrasonography (US) or transcranial Doppler (TCD), and have used relatively small~     cohorts~      The primary goal of this study is to investigate whether there is a correlation between~     neovascularisation in the carotid atherosclerotic plaque as observed with 3.0 Tesla dynamic~     contrast-enhanced MRI and histology. Moreover, the investigators aim to investigate the~     correlation between the volume of the LRNC as determined by dual-energy CT and histology.~      Secondly, the investigators will investigate the correlation between the volume of the LRNC,~     the fibrous cap status and the volume of the calcifications determined by MRI versus~     histology, the correlation between number of microembolisms and fibrous cap status and the~     correlation between the deformation pattern seen with ultrasound and the volume of the LRNC.~      The imaging parameters showing good correlation with plaque vulnerability characteristics can~     be used for further analysis in assessing the vulnerable plaque~   "
141967|NCT01709032|"~     We hypothesize that the combination treatment with deferasirox and deferiprone will be well~     tolerated and will result in significant improvement in cardiac and liver iron levels.~   "
141968|NCT01709019|"~     Up to 220 eligible subjects will be enrolled into one of five treatment groups. It is~     anticipated that some of the randomized study subjects may not complete the study; subjects~     who withdraw or are discontinued, will not be replaced. Randomization will be stratified by~     age (60 to <75 years and ≥ 75 years) in order to distribute the proportion of such persons in~     each age group equally across treatment groups.~      Treatments will comprise a single IM dose of a placebo or RSV-F protein nanoparticle vaccine~     on Day 0, with concurrent IM immunization with a licensed inactivated influenza vaccine. A~     rescue dose of the licensed TIV will be provided to subjects in all groups except the placebo~     group on Day 28, the placebo group will receive saline. For each subject, study follow-up~     will span approximately one year from the first immunization (on Day 0) for all subjects.~   "
141969|NCT01709006|"~     It is currently estimated that above 50% of new cancer cases are diagnosed in the elderly~     population[1]. With the increased life expectancy in the industrialised countries, the~     incidence of head and neck cancers has significantly increased in the last decade with rates~     estimated between 24-40% in patients over 70 years old [2-4]. It is estimated that with the~     improvement in quality of life and treatment modulation, the incidence will continue to rise~     in the coming years. Because the current available prospective studies often exclude patients~     above 65 or 70 years old, the data and guidelines on head and neck treatment for these~     patients population remain limited.~      Treatment of elderly patients with advanced stage III-IV oropharyngeal squamous carcinoma~     with intensity modulated radiotherapy (IMRT) using RapidArc® or Helical Tomotherapy® at a~     dose of 70 Gy in 33 fractions to the PTV (GTV) and 59.4 Gy in 33 fractions to the first~     disease-free lymphatic relay bilaterally as well as a combination Cisplatin chemotherapy at a~     reduced dose.~   "
141970|NCT01708993|"~     The purpose of this study is to find out if giving reolysin in combination with docetaxel or~     pemetrexed can offer better results than standard therapy with docetaxel or pemetrexed alone.~   "
141971|NCT01708980|"~     Background:~      In the early phase after a total knee replacement (TKA), patients experience multi-level~     weakness in the operated leg, which is caused primarily by reduced central (CNS) activation~     failure of the muscles - especially the knee extensors. This considerable loss of muscle~     strength relates to reduced functional performance. The investigators recently reported that~     early-commenced physiotherapy, including progressive strength training performed in machines,~     seems feasible after TKA. The question is, if neuromuscular activity of the muscles in the~     operated leg, elicited during strength training in machines, can be reached during strength~     training in more simple forms? Many clinicians are faced with the problem of not having~     strength training equipment at their institution, or having to prescribe simple strength~     training exercises for home-based training.~      Purpose and hypothesis:~      The purpose of this study is to determine which strength training exercises that activate the~     muscles in the operated leg the most after TKA. The hypothesis is that strength training~     exercises performed in machines is more effective compared to strength training performed in~     more simple forms (using elastic bands or own body weight, etc.).~      Participants and methods:~      Twenty participants with a unilateral TKA, operated between 4 to 8 weeks prior to the first~     investigation, will be included. The participants are investigated twice. During the first~     investigation, the absolute load (kilograms) corresponding to 10 Repetition Maximum (RM) (a~     load that can be lifted exactly 10 times) will be determined for all the exercises. At least~     72 hours later, the participants will undergo an electromyographic analysis, which determines~     the neuromuscular activity of the thigh muscles in the operated leg.~      Ethical issues:~      From a pilot study, the investigators found that strength training exercises commenced early~     after TKA seems feasible as the exercises did not increase knee joint swelling or knee pain.~     None of the financial supporters, or any of the authors, have any potential conflicts of~     interest with regard to the study.~   "
141972|NCT01708967|"~     This study designed for compare efficacy of following two anesthetic method for transnasal~     endoscopy~        -  Catheter-free method~        -  Catheter-insertion method~   "
141973|NCT01708954|"~     This randomized phase II trial studies how well giving erlotinib hydrochloride and~     cabozantinib-s-malate alone or in combination works as second or third line therapy in~     treating patient with stage IV non-small cell lung cancer. Erlotinib hydrochloride and~     cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes~     needed for cell growth. It is not yet known whether giving erlotinib hydrochloride together~     with cabozantinib-s-malate is more effective than erlotinib hydrochloride or~     cabozantinib-s-malate alone in treating non-small cell lung cancer.~   "
141974|NCT01708941|"~     This randomized phase II trial studies how well ipilimumab with or without high-dose~     recombinant interferon alpha-2b works in treating patients with stage III-IV melanoma that~     cannot be removed by surgery. Monoclonal antibodies, such as ipilimumab, may block tumor~     growth by targeting certain cells. Recombinant interferon alfa-2b may interfere with the~     growth of tumor cells. It is not yet known whether ipilimumab is more effective with or~     without high-dose recombinant interferon alfa-2b in treating melanoma.~   "
141975|NCT01708928|"~     Up to 30 subjects will be enrolled. All subjects will receive one Ultherapy treatment to the~     lower two thirds of the face and neck. Subjects will be equally grouped into those with a~     history of submentoplasty and or rhytidectomy and those naive to submentoplasty and or~     rhytidectomy. Follow-up visits will occur at 14, 30, 60, 90 and 180 days following treatment.~     Study images will be obtained pre-treatment, 30-60 minutes post-treatment, and at each~     follow-up visit.~   "
141976|NCT01708915|"~     The aim of this study is to assess the efficacy and tolerability of Nicoboxil/Nonivamide~     ointment in comparison to Nicoboxil, Nonivamide, and placebo ointments for the treatment of~     acute low back pain.~   "
141977|NCT01708902|"~     Reduced factorial design study with 24 week randomized treatment of initial combination~     therapy with linagliptin and metformin in T2DM patients~   "
141978|NCT01708889|"~     The purpose of this study is to determine the effect of renal impairment on pharmacokinetics~     (PK) of BMS-914143.~   "
141979|NCT01708876|"~     Preliminary studies have supported the background efficacy of local standard anti-malarial~     medications in the treatment of uncomplicated knowlesi malaria, however this has not been~     tested systematically and there are no current WHO treatment guidelines for this infection.~     There are both health cost benefits to a more rapidly acting agent, and due to difficulties~     with microscopic identification there may be more effective treatment for all malaria species~     if an aligned treatment guideline could be supported. In addition, no therapeutic efficacy~     monitoring of current first line anti-malarials used for the treatment of P. vivax malaria~     have been conducted in Malaysia.~      The investigators aim to test whether the fixed combination of artesunate-mefloquine is~     superior to chloroquine in order to define the optimal treatment for both uncomplicated P.~     knowlesi and P. vivax infection in both adults and children in this region.~   "
141980|NCT01708863|"~     Hypoplastic left heart syndrome (HLHS) is a severe form of congenital heart disease that~     consists of multiple obstructions to flow through the left heart and aorta, as well as~     hypoplasia of the left ventricle. Most patients require a three-stage surgical protocol~     starting within days of birth. Stage I of this process is the Norwood reconstruction (within~     the first few days of life), Stage II (usually required within 3-8 months) involves creation~     of a direct connection between the patient's superior vena cava and the pulmonary arterial~     confluence (bidirectional Glenn anastomosis), and the last stage is creation of a Fontan~     circulation (typically within the first 2-4 years). This single ventricle approach requires~     the right ventricle to perform as the only circulatory pump for the entire body.~      Our long-term goal is to develop regenerative strategies to strengthen and augment the right~     ventricular muscle of the single-ventricle heart following surgical palliation in HLHS~     patients. To determine the safety and feasibility of a cell-based therapeutic intervention at~     the Stage II surgery, we aim to document the natural history of post-surgical care in HLHS~     patients having undergone standard of care with protocol specific follow-up over the course~     of a 6-month period.~      This prospective study will document the natural history in patients with HLHS after planned~     Stage II surgical palliation with a focus on cardiovascular parameters within 6 months~     following surgery in 10-20 patients.~   "
141981|NCT01708850|"~     Patients with cancer and an upper extremity DVT associated with a central venous catheter~     (CVC) will receive rivaroxaban. CVC survival will be assessed and compared to previous rates~     with low molecular weight heparin (LMWH) and warfarin, along with secondary safety outcomes~     including bleeding and recurrent venous thromboembolism.~      The investigators hypothesize that anticoagulation with rivaroxaban in patients with UEDVT~     secondary to central venous catheters in patients with active malignancy is an effective~     therapy as quantified by the success of catheter preservation. Prolonged line salvage rate~     without recurrence of UEDVT will improve the management of cancer patients who develop an~     upper extremity deep venous thrombosis in the setting of a central venous catheter.~   "
141982|NCT01708837|"~     The purpose of this study is to investigate whether the depth of anesthesia with propofol~     affects the incidence of early postoperative cognitive dysfunction~   "
141983|NCT01708824|"~     Background - Colorectal cancer (CRC) incidence is increasing at an alarming rate in Hong~     Kong. A recent report concluded physical activity (PA) protects against colon cancer and~     foods low in dietary fibre, red meat and processed meat cause CRC. Yet, the influence of~     lifestyle factors on cancer outcome (i.e. recurrence and survival rates) in CRC survivors is~     largely unknown.~      Objectives & hypothesis - Our study aims to evaluate the acceptability of two behavioural~     interventions for CRC survivors intended to improve cancer outcome and designed to (1)~     increase PA levels and (2) reduce consumption of a Western diet.~      The investigators hypothesize that the proposed interventions are (1) efficacious in changing~     the two targeted behaviours; and (2) acceptable to CRC survivors.~      Settings and methods - Phase 2 feasibility trial. Two hundred and twenty-four CRC survivors~     within 12 months of completion of cancer treatment and without evidence of~     persistent/recurrent disease will be recruited from four public hospitals in Hong Kong after~     informed consent. Subjects will be randomized in a 2x2 factorial design for the two targeted~     behaviours prescribed over 12 months. Primary outcome measure is whether the target levels of~     PA and dietary intake could be met at the end of intervention. Secondary outcome measures~     include: (1) magnitude of changes in PA level and dietary intakes; (2) rates and determinants~     of compliance; (3) facilitators and barriers to behavioural change; (4) measurement of~     theoretical constructs underlying PA and dietary interventions; (5) possible health benefits~     and side effects (PA-associated injury and nutritional deficiency) arising from the~     interventions. Outcome will be assessed at baseline, 6 months into intervention and then at~     0, 6 and 12 months post-intervention.~      Impact - If proven feasible, our intervention programme would pave way for a large randomized~     controlled trial testing the effect of PA and diet on the treatment outcome of CRC.~   "
141984|NCT01708811|"~     Hyponatremia during labour has been associated with prolonged labour, and increased incidence~     of instrumental delivery and emergency caesarean section. Sodium influx in myometral cells~     are involved in contractility,and and influence of hyponatraemia on contractility can be~     suspected.~   "
142016|NCT01708395|"~     The investigators believe that patients with ulcerative colitis are able to report details of~     their own medical history accurately and record changes in clinical status effectively over~     time. Using an internet-based database the investigators will ask patients to report their~     own disease history, and the investigators will compare their reports to the medical record.~   "
141985|NCT01708798|"~     Doxorubicin and other anthracyclines are commonly used to treat breast cancer and other types~     of cancer. Unfortunately, they can cause heart muscle damage, resulting in scarring, abnormal~     contraction and relaxation, and heart failure symptoms. This side effect occurs more~     frequently at higher doses, and limits the total dose that can be given to cancer patients.~     Eplerenone is an oral medication that prevents or reverses heart damage in other disease~     states, and is commonly used to treat heart failure. This study will investigate the use of~     eplerenone to protect the heart from these harmful side effects of doxorubicin.~      Few therapies have been shown to prevent heart damage in patients receiving anthracyclines.~     Small studies have suggested that other heart failure medications (ACE inhibitors,~     beta-blockers) may reduce the incidence of cardiac toxicity, but eplerenone and other drugs~     in its class (aldosterone antagonists) have not previously been studied. Eplerenone inhibits~     enzyme pathways that cause scarring of the heart, and animal studies suggest that~     anthracyclines cause damage through these same pathways.~      This study aims to investigate whether eplerenone protects the heart from the harmful effects~     of doxorubicin chemotherapy. Specifically, it will measure the effect that eplerenone has on~     heart muscle relaxation. It will randomly assign women undergoing chemotherapy with~     doxorubicin to one of two groups: one group will receive eplerenone, and the other group will~     receive placebo (sugar) pills. The subjects will not know which type of pills they are~     taking. Heart muscle relaxation will be measured at baseline, after completion of~     chemotherapy (8-12 weeks), and after 6 months. There will also be various blood tests~     measured in the study subjects, to determine whether there might be certain blood tests that~     identify patients at particularly high risk of heart toxicity after doxorubicin therapy.~   "
141986|NCT01708785|"~     The purpose of this study is to optimize an obesity treatment program targeting overweight~     8-12 year old children using Cue Exposure Training.~   "
141987|NCT01708772|"~     A total of ninety patients (52men and 38women) were included in the study. Forty five~     patients developed septic complication during ICU stay (sepsis group). Forty five patients~     were critically ill without evidence of infectious organism (SIRS group). At admission,~     Patients data include clinical status; SOFA score; central venous pressure; laboratory~     analysis and arterial blood gas analysis were measured. Routine cultures were obtained. The~     attending physician evaluated the patients for sepsis, severe sepsis, or septic shock as long~     as their stay in ICU. A serum level of TNF-a and SOFA score was monitored.~   "
141988|NCT01708759|"~     One hundred eighty critically ill African adult intensive care patients divided into two~     groups, eighty septic critically ill patients (sepsis group) while, eighty non-septic~     critically ill patients (SIRS) group. Admission serum IL-8 was measured in both sepsis and~     SIRS groups. IL-8 (-251A/T) polymorphism was detected in sepsis and SIRS groups.~   "
141989|NCT01708746|"~     This is a prospective, single-institution observational study to be conducted at 4 clinics~     within the Southern California Permanente Medical Group. Pregnant women who present for~     prenatal genetic counseling at the designated clinics and who meet study eligibility criteria~     will be offered the option of the verifi® prenatal test by a trained, licensed and certified~     genetic counselor (GC) . Women who elect the verifi® prenatal test will have a blood sample~     drawn by peripheral venipuncture that will be sent to the Verinata Health CAP-accredited~     clinical laboratory (Redwood City, CA). Results will be reported to the ordering health care~     provider by the laboratory within 8-10 business days and will be shared with the subject by~     their provider. Subject care and decision-making following NIPT result will be clinically~     managed by the provider with his/her subject and is not dictated by the study protocol. All~     eligible women who provide informed consent, whether they elect or decline NIPT will be asked~     to complete a short questionnaire on their views of prenatal testing. The uptake of invasive~     prenatal procedures (CVS and/or amniocentesis) by the total prospective cohort will be~     collected through review of electronic medical records (EMR). A historical cohort with~     matched demographic and pre-test indications to the prospective cohort will be identified~     from the EMR for comparison in the primary analysis.~   "
141990|NCT01708733|"~     The aim of the study is to examine whether the Chinese herbal formula (KSY) is effective on~     HCV Carrier With Abnormal Liver Function.~   "
141991|NCT01708720|"~     The purpose of this trial is to determine whether the new inactivated polio vaccine that is~     based on attenuated poliovirus strains is safe and to evaluate the immune response in healthy~     adults.~   "
141992|NCT01708707|"~     The purpose of the study is to determine whether buprenorphine is a beneficial, safe, cost~     effective treatment alternative to morphine sulfate in the treatment of Neonatal Abstinence~     Syndrome (NAS).~   "
141993|NCT01708694|"~     The purpose of this study is to determine the effect of a slowly digesting starch on gut~     bacteria, sugar and fat metabolism, hunger hormones, and body fat in people with~     pre-diabetes.~   "
141994|NCT01708681|"~     Despite numerous studies of meal components in humans, little is still known about how~     different meals influence on metabolism. The purpose of this study is to a gain knowledge of~     how a balanced test meal with either lean seafood (example:cod) or meat as the main protein~     source will:~        1. affect the postprandial metabolism acutely (test-meal at beginning of the study)~        2. affect the postprandial metabolism after 4 weeks controlled intervention (test meal at~          end of intervention period)~        3. affect gut microbiota composition~   "
141995|NCT01708668|"~     Epidural analgesia is associated with maternal intra-partum fever during labor. Intermittent~     epidural injections appear to reduce the incidence of maternal intra-partum fever compared to~     continuous epidural infusion during labor analgesia. However, the optimal combination of~     bolus volume and administrating interval has not yet been compared. The purpose of this~     prospective, randomized, double-blind trial was to determine how intermittent epidural bolus~     reduced the incidence of maternal intra-partum fever compared with continuous epidural~     infusion during labor.~   "
141996|NCT01708655|"~     The investigators hypothesize that measurement of beta adrenergic induced sweat rate using an~     evaporimeter can accurately and reliably determine different levels of CFTR dysfunction~     within a spectrum of patients expressing various degrees of cystic fibrosis disease.~      The investigators overall goal is to determine whether the evaporimeter technique of~     measuring beta-adrenergic induced sweat rate is capable of accurately and reliably~     identifying different levels of CFTR dysfunction, as a prerequisite before advancing this~     technique as biomarker assay into clinical trials.~   "
141997|NCT01708642|"~     The purpose of this study is to evaluate the effect of intraoperative administration of~     low-dose adrenaline on intraoperative blood loss in patients undergoing hip surgery.~   "
141998|NCT01708629|"~     The purpose of this study is to assess the safety and efficacy of brodalumab at two different~     doses compared with placebo in participants with moderate to severe plaque psoriasis.~      A second purpose of this study is to assess the safety and efficacy brodalumab at two~     different doses compared with ustekinumab in participants with moderate to severe plaque~     psoriasis.~      A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens~     of brodalumab.~   "
141999|NCT01708616|"~     This single-center, randomized, double-blind, two-period crossover study will evaluate the~     safety, tolerability, pharmacokinetics and pharmacodynamic effects of the combination of~     multiple doses of RO5285119 with a single dose of risperidone in healthy volunteers. Subjects~     will be randomized to one of 4 treatment sequences of two periods to receive multiple doses~     of RO5285119 plus a single dose of risperidone or risperidone placebo or multiple doses of~     RO5285119 placebo plus a single dose of risperidone or risperidone placebo, with a washout~     period of approximately 3 weeks between treatment periods. Anticipated time on study is up to~     12 weeks (from screening through study completion).~   "
142000|NCT01708603|"~     The purpose of this study is to assess the safety and efficacy of brodalumab at two different~     doses compared with placebo in participants with moderate to severe plaque psoriasis.~      A second purpose of this study is to assess the safety and efficacy brodalumab at two~     different doses compared with ustekinumab in participants with moderate to severe plaque~     psoriasis.~      A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens~     of brodalumab.~   "
142001|NCT01708590|"~     The purpose of this study is to assess the safety and efficacy of brodalumab taken every two~     weeks at two different doses in participants with moderate to severe plaque psoriasis.~      A second purpose of this study is to assess the safety and efficacy when brodalumab is~     replaced with placebo in some participants compared with the participants who are still~     receiving the brodalumab.~   "
142002|NCT01708577|"~     The purpose of the study is to evaluate the feasibility of a new wearable computerised system~     designed for an ongoing monitoring of sportsmen under real-life conditions. This system~     consists of different sensors and Bluetooth Transmitters interconnected by wires and~     integrated in the textile of a T-shirt. Several physiologic parameters including bioimpedance~     should be investigated under conditions relevant for an intensive physical activity, like~     high body temperature or partial dehydration. This system has to be tested under laboratory~     and natural/open air conditions, the obtained evaluations compared with standardised~     established diagnostic methods.~   "
142003|NCT01708564|"~     This study will assess the pharmacokinetics and pharmacodynamics of rhFVIIa at three dose~     levels. The results will help identify the most optimal doses to take forward to the Phase~     2/3 studies where bleedings in hemophilia patients with inhibitors will be treated with~     rhFVIIa.~   "
142004|NCT01708551|"~     Up to 60 subjects will be enrolled into one of five treatment groups. Subjects enrolled in~     Groups A, B or C will undergo axillary punch biopsies during the course of the trial to~     determine the number and depth of the sweat glands, and receive dual depth treatments (4.5mm~     and 3.0mm); either two bilateral Ultherapy™ treatments to the axillas 30 days apart (Groups A~     and B) or one bilateral Ultherapy™ treatment (Group C). Subjects in Groups D and E will~     receive two bilateral Ultherapy™ treatments to the axillas 30 days apart at a 2.0mm treatment~     depth and two different energy settings (Group D at 0.45 J, Group E at 0.30 J). Protocol~     amended (Sept 2014): Subjects in Groups D and E will receive treatments at the same energy~     setting (0.30J) and two treatment densities: Group D, 60 lines/treatment square; Group E, 40~     lines per treatment square. Follow-up visits will occur at 7, 30, 90 and 180 days~     post-treatment #2.~   "
142005|NCT01708538|"~     The corneal collagen cross-linking treatment has been used with increasing success to treat~     corneal dystrophies such as keratoconus. Recent advances have allowed different techniques~     for performing this cross-linking treatment. This study investigates the effects of corneal~     cross-linking using different surgical techniques.~   "
142006|NCT01708525|"~     Enrolled subjects undergo tissue labeling to evaluate the rate of collagen synthesis in~     tissue treated with the Ulthera® System compared to control tissue.~   "
142007|NCT01708512|"~     All enrolled subject will receive one Ultherapy™ treatment. Study images will be obtained~     pre-treatment, immediate post-treatment, and at each study follow-up visit. Enrolled subjects~     will return for follow-up visits at 90 days, 180 days and 365 days post-treatment.~   "
142008|NCT01708499|"~     Enrolled subjects will receive one UltherapyTM treatment on the abdomen. Follow-up visits~     will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment,~     immediately post-treatment, and at each follow-up visit.~   "
142009|NCT01708486|"~     Patients' satisfaction with their asthma medication devices is usually decided by using~     properly designed questionnaires. These questionnaires are to be used to evaluate patients'~     opinion, which is considered very important for the selection of a device.~      The Feeling of Satisfaction with Inhaler (FSI-10) is a self-completed questionnaire designed~     to assess the patient opinion regarding the satisfaction and usability of the inhalers~     irrespectively of the drug used. It consists of 10 question each with 5 possible responses on~     a 5-point Likert scale scored from 5 to 1, respectively. The total score can range between 10~     and 50. The higher the score, the higher the feeling of patient satisfaction from the~     inhaler.~   "
142010|NCT01708473|"~     This study will compare the effectiveness of two pain medications for reducing discomfort~     during an Ultherapy treatment.~   "
142011|NCT01708460|"~     Up to 30 subjects will be enrolled. Enrolled subjects will receive an Ulthera® treatment to~     one side of the body, treating the lateral buttock region. Follow-up visits will occur at 90~     and 180 days post-treatment. Study images will be obtained pre-treatment, immediately~     post-treatment, and at each follow-up visit.~   "
142012|NCT01708447|"~     This study will evaluate the efficacy of a lidocaine topical anesthetic (numbing cream) for~     reducing discomfort associated with Ultherapy™ treatment.~   "
142013|NCT01708434|"~     Enrolled subjects will receive one bilateral Ulthera® treatment on the knees. Up to 30~     subjects will be enrolled. Study photos will be obtained prior to study treatment,~     immediately following study treatment, and at each post-treatment follow-up visit. Follow-up~     visits will occur at 90 and 180 days post-treatment.~   "
142014|NCT01708421|"~     The purpose of this study is to examine the phenotypic and genotypic characteristics and~     their associations with symptom clusters experienced during treatment for childhood leukemia.~   "
142015|NCT01708408|"~     The MURDOCK Study Community Registry and Biorepository (Horizon 1.5) aims to create a~     large-scale community registry and biorepository that can be used as a vehicle for future~     health services, epidemiologic, clinical trials and other omics-related research.~   "
142018|NCT01708369|"~     The purpose of this study is to determine if alcohol is able the affect the body's ability to~     eliminate two commonly used medication, oseltamivir and aspirin. We hypothesize that drinking~     alcohol may reduce the body's ability to break down these two medications along with many~     others.This could affect the amount of drug in the blood which could impact how well these~     drugs work and whether patients have side effects.~   "
142019|NCT01708356|"~     Introduction: Cycling is currently promoted at the municipal, provincial and national level~     as a form of active transportation that increases physical activity while at the same time~     reducing traffic congestion, traffic-related air pollution and greenhouse gas emissions.~     While at a population level the health benefits of exercise via cycling are estimated to~     substantially exceed any health impacts related to air pollution exposure and injuries from~     traffic accidents , cyclists are known to experience elevated exposures to traffic-related~     air pollutants. Combined with exposure to elevated concentrations of air pollutants, cyclists~     also are subject to substantially increased inhaled doses due to their level of exertion and~     consequently increased inhalation rate. Therefore, given that cyclists experience exposures~     to relatively high concentrations of traffic-related air pollutants and that their inhalation~     of these pollutants is increased, it is important to evaluate the potential health impacts of~     this scenario. Research on the potential health impacts related to exercise (cycling) and~     urban air pollution exposure can help inform public communication strategies related to air~     quality and its health impacts. In addition, as our previous work suggests substantial~     variability in air pollution exposures to cyclists that is related to the route type and the~     levels of traffic along cycling routes, there is potential for transportation planners to~     promote increased cycling by enhancing infrastructure while at the same time developing~     routes that also minimize exposure to air pollution. The cyclist population is also~     interested in information regarding the air pollution exposures and potential health impacts~     related to cycling.~      The objective of this study is to investigate the relationship between traffic-related air~     pollution exposure, and respiratory and cardiovascular health impacts in commuting cyclists.~     Specifically, the investigators propose to:~        1. determine commuting cyclists' exposure to traffic-related air pollutants (PM 2.5, PM10,~          ultrafine particulate, black carbon) while cycling along two different bicycle routes in~          the city of Vancouver;~        2. estimate the pollutant dose received by each cyclist, and relate this to the health~          effects observed; and~        3. determine if there is a change in lung function, endothelial function, and C-reactive~          protein level related to the level of air pollution exposure and dose~   "
142020|NCT01708343|"~     To test the hypothesis that the effect of either multiple deep intramuscular stimulation~     therapy [(DIMMST: trigger point deep dry needling (TrP-DDN) is combined with paraspinal deep~     intramuscular stimulation (PDIMS) and needle rotation (NR)] would be more effective than a~     placebo-sham for the treatment of MPS and that DIMMST would be more effective than LTrP-I for~     improving pain relief, sleep quality, and physical and mental state of the patient.~   "
142021|NCT01708330|"~     When a patient requires a manual vacuum aspiration (MVA), whether for an undesired pregnancy,~     missed abortion, or other nonviable pregnancy, she is undergoing an emotional experience. She~     is grieving the loss of her pregnancy, and is then faced with the anxiety of an invasive and~     often painful procedure. Minimizing the pain during this procedure must not be overlooked.~     There have been no randomized controlled trials evaluating pain control during MVA for~     nonviable pregnancy, and the data is mixed regarding analgesia for MVA for an elective~     abortion or other office procedures.~      Women being treated at the Women & Infants Triage who have experienced a first trimester~     missed abortion, inevitable abortion, incomplete abortion or other nonviable pregnancy and~     are being treated with an outpatient manual vacuum aspiration will be asked to enroll in this~     study. Those who wish to participate will be randomly assigned to treatment with lidocaine~     gel or a placebo gel applied to the cervix during their procedure.~      The hypothesis is that topical lidocaine will decrease pain during manual vacuum aspiration.~   "
142022|NCT01708317|"~     The purpose of this study is to determine if an Audio-enhanced Computer-Assisted~     Self-Interview (ACASI) will lead to increase testing for sexually transmitted infections in~     youth visiting a pediatric ED~   "
142023|NCT01708304|"~     The University of Washington's Northwest Research Group on Aging is partnering with Area~     Agencies on Aging (AAA) in Washington and Oregon to complete this translational investigation~     of RDAD (Reducing Disabilities in Alzheimer's Disease). RDAD is an evidence-based program~     with demonstrated efficacy in helping older adults with dementia maintain physical function~     and remain physically and mentally healthy. This study asks two questions: 1) Can AAA~     partners successfully translate and implement RDAD, and 2) Is AAA implementation of RDAD~     effective in producing desired outcomes among agencies, providers, and older adults with~     dementia and their family members. This study is being conducted in Washington and Oregon~     states.~   "
142024|NCT01708291|"~     This project will measure baseline stress among a group of youth in foster and kinship care.~     The investigators will implement a pilot program to target stress reduction by using an~     evidence-based group therapy technique teaching mindfulness skills. The investigators~     hypothesize that the mindfulness skills will help youth to reduce stress, which will be~     measured using psychological and physiological techniques.~   "
142025|NCT01708278|"~     Chronic obstructive pulmonary disease (COPD) is a progressive disorder of the lung parenchyma~     and airways, which is the third-leading cause of death in the USA. Current therapies for COPD~     are only partially effective and may also have side effects. Although increasing evidence~     indicates that quercetin supplementation may be beneficial in treating COPD, key~     methodological issues have not been resolved. The overall objective of this study is to~     determine the dosage of quercetin supplementation, bioavailability of quercetin, safety,~     dose-response relationship and appropriate biomarkers which reflect clinical outcomes in~     patients with COPD that is necessary for conducting large clinical trials in this patient~     population.~   "
142026|NCT01708265|"~     The purpose of this study is to compare early mitral valve repair versus a watchful waiting~     strategy in asymptomatic patients with severe organic mitral valve regurgitation and~     preserved left ventricular function.~   "
142027|NCT01708252|"~     Up to 10 subjects will be enrolled. All subjects will receive an increased density~     UltherapyTM treatment at dual depth. Treatments will be provided to the lower 2/3 of the face~     and neck. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be~     obtained pre-treatment, 30-60 min post-treatment, and at each follow-up visit.~   "
142040|NCT01708083|"~     Fat tissue from omenta, thigh and abdomen taken under anesthesia on subjects undergoing~     laparoscopic surgery, cholecystectomy, reflux surgery or gastric by-pass (GBP).~      Are there any difference in polymorphids and/or mRNA expression in genes significant for~     developing obesity, between normal weight and obese individuals, with or without diabetes typ~     2 .~      Are there any difference in polymorphids and/or mRNA expression in different types of fat~     tissue~   "
142041|NCT01708070|"~     Although depressive and anxious symptoms are common in asthma patients and are associated~     with worse clinical and resource utilization outcomes, there have been no studies focusing on~     the particular challenges of improving asthma self-management in this population. The~     investigators hypothesize that a tailored intervention to improve asthma self-management in~     patients with a known history of depressive and anxious symptoms will be effective in~     improving asthma-related quality of life.~   "
142028|NCT01708239|"~     In pregnant women with suspected DVT, a sure diagnosis is mandatory. In non-pregnant~     patients, sequential diagnostic strategies based on 1) the assessment of clinical~     probability, 2) D-dimer measurement and 3) compression ultrasonography (CUS) have been well~     validated.~      Clinical probability assessment by clinical prediction rules (CPRs) is a crucial step in the~     management of suspected DVT. However, the most commonly used CPR for DVT, the Wells' score,~     has never been validated in pregnant women. Recently, the 'LEFt' clinical prediction rule was~     derived and internally validated. A prospective validation of this rule is now warranted, and~     we plan to use it in our prospective study.~      The second step used in the diagnostic strategy including non-pregnant patients is D-dimer~     measurement. The test has been widely validated in non-pregnant patients and, in association~     with a non-high clinical probability, it allows to safely rule out DVT.~      As D-dimer level raise steadily during pregnancy, the specificity of the test decreases and~     it is less useful in pregnant women. Data from the literature clearly suggest that the usual~     cut-off set a 500 ng/ml would safely rule out DVT in pregnant women [6]. As the usual cut-off~     has never been prospectively validated in pregnant women with suspected DVT, we would like to~     use it in our study.~      Some studies suggested that complete CUS is safe to rule out DVT in pregnant women. However,~     this test is not always available. Therefore, a strategy in which the association of clinical~     probability assessment and D-dimer measurement would allow to safely rule out DVT in a~     significant proportion of patients without performing a complete CUS, would be of great help~     in everyday clinical practice and would probably be cost-effective.~      Therefore, we plan a prospective study to assess the safety of a sequential diagnostic~     strategy based on the assessment of clinical probability with the LEFt rule, D-dimer~     measurement and complete CUS in pregnant women with suspected DVT.~   "
142029|NCT01708226|"~     Pediatric Obsessive Compulsive Disorder (OCD) is a chronic, impairing condition that accrues~     significant concurrent and long-term risk to affected youth. Although empirically supported~     psychosocial and pharmacological treatments for OCD exist, many children and their families~     are not able to adequately access these treatments or derive only partial benefit from them.~     Such findings highlight the importance of developing more effective treatment options which~     have the potential to be widely accessible to OCD youth.~      The investigators are proposing to test a computerized attention modification program, AMP,~     in six youth with OCD in an open case series to gather information regarding protocol~     acceptability, feasibility and preliminary efficacy. This phase includes the development and~     refinement of stimuli selection procedures, behavior avoidance task, EEG protocol, and AMP~     parameters for use with children.~      Following ascertainment of study eligibility, participants will undergo a baseline assessment~     consisting of a clinical interview, neurocognitive assessments, EEG, attention bias~     assessment, and self report questionnaires. Study participants will then receive 12 sessions~     of AMP treatment over the course of three weeks. All youngsters and their families will be~     reassessed at treatment endpoint (week 4). Participation will take a total of about 24 hours~     over the course of six weeks. Participants who are treatment responders may be asked to~     return approximately 3 months after completing treatment for a follow-up assessment.~      Preliminary hypotheses: 1) AMP will be acceptable to youth and families and feasible to~     administer; 2) Youth receiving AMP will demonstrate decreases in threat bias and OCD symptom~     severity.~   "
142030|NCT01708213|"~     The protocol hypothesis is that treatment with Aline HA™ will be safe through 6 months as~     determined by clinical assessment of treatment sites and routine tracking of adverse events.~   "
142031|NCT01708200|"~     This study will compare the effectiveness of a psychoeducational memory program versus a~     computerized memory program in individuals with mental illness. Although improvements are~     expected with both form of interventions, we do not know which will provide maximal benefit~     in this population.~   "
142032|NCT01708187|"~     Peroneal tendon tears are a common etiology encountered by foot and ankle surgeons. Like all~     flexor tendon repairs adhesions are one of the more common challenges after surgery. Peroneal~     tendon gliding is key to their function as effective plantar flexors and evertors of the~     hindfoot. Scarring and adhesion correlate directly with the amount of inflammatory reaction~     at the wound site (Adzick 1994). Our goal is to have a surgical technique that allows for~     standard suture repair of the tendon yet allows for smooth gliding of the tendon with minimal~     adhesions. A prospective review on the surgical repair of the peroneal tendons utilizing~     Clarix™1k (Amniox Medical, Marietta, GA), cryopreserved Human Amniotic Membrane (C-HAM) graft~     will be performed. The investigators hypothesize that the use of cryopreserved Human Amniotic~     Membrane in conjunction with a peroneal tendon repair will decrease that amount of~     inflammation, overall recovery time of surgically repaired peroneal tendon tears, and~     adhesions.~   "
142033|NCT01708174|"~     This Phase II study evaluated the safety and efficacy of LDE225 in adult and pediatric~     patients with Hh-pathway activated, relapsed MB.~   "
142034|NCT01708161|"~     This was a multi-center, open-label, phase Ib/II study. The aim of the phase Ib part was to~     estimate the MTD(s) and/or identify the recommended phase II dose(s) (RP2Ds) for the~     combination of BYL719 and AMG 479 (ganitumab), followed by the phase II part to assess the~     clinical efficacy and to further assess the safety of the combination in selected patient~     populations. Patients were to be treated until progression of disease, unacceptable toxicity~     develops, or withdrawal of informed consent, whichever occurred first. All patients were to~     be followed up. At a minimum, patients must have completed the safety follow-up assessments~     30 days after the last dose of the study treatment.~   "
142035|NCT01708148|"~     The aim of this study is the improvement of the penile linked neovaginal flora in~     male-to-female transsexuals after application of oral probiotics.~   "
142036|NCT01708135|"~     This current study aims to evaluate the efficacy of engagement modules in preparing patients~     for bariatric surgery. With the help of the Center for Innovation (CFI), a smartphone app~     (Android and Apple compatible) has been created that will assist in both educating and~     engaging patients to develop and maintain healthy lifestyle modifications. Our goal is to~     create a cost-effective, smartphone-based platform that serves to not only efficiently~     educate but to also verify competence and keep our patients engaged during the lengthy~     pre-bariatric surgery process.~   "
142037|NCT01708122|"~     The purpose of this study is to assess the efficacy of intranasally-administrated fentanyl~     spray to decrease the pain during cystoscopy (the passage of a telescopic instrument into the~     bladder for purpose of diagnosing the cause of blood in the urine, urinary complaints or any~     other problems with the urinary bladder). The current standard practice is to use Lidocaine~     jelly (a local anesthetic) given through the urethra to lubricate and decrease pain. In this~     study, an additional medicine (fentanyl) is used to reduce pain that occurs during and after~     the above procedure.~   "
142038|NCT01708109|"~     The purpose is to study natural process of gallstones in common bile duct, stones less than~     or equal to 6 mm. And if the gallstones give any complications under 1 year follow up. The~     second outcome is to study side-effects of gallstones removed with surgery.~   "
142039|NCT01708096|"~     The aim of the study is to develop new strategies in treatment of continuous increasing~     number of patients with type 2 diabetes by understanding how bariatric surgery cures or~     improves this condition.~   "
142044|NCT01708031|"~     Computerized Mental Arithmetic Task Based Human Stress Level Detection Using Physiological~     Signal~      The objective of this study is to induce and measure the human stress level through~     computerized mental arithmetic task and multiple physiological signals (ECG, EMG, GSR, and~     skin temperature). Studies suggested that mental arithmetic task is one of the efficient~     stimuli to induce the stress. Hence, this mental arithmetic task protocol has been improved~     in to computerized version. The protocol will be tested with normal subjects and multiple~     physiological signals will be acquired simultaneously. The questionnaire about the subject~     experience will be obtained in order to strengthen the stress induction. The normal volunteer~     subjects will be invited for the participation this study. The physiological signal will be~     analyzed using suitable algorithm based on the characteristics of each signals. The multiple~     signal based stress level assessment system will be developed by training and testing the~     acquired data.~   "
142045|NCT01708018|"~     This study will be the first scientific approach to investigate physical and psychological~     effects of the passive hydrotherapy-method WATSU (WaterShiatsu) on women and their unborn~     children at the third trimester of pregnancy. Potential therapeutic benefits of the method~     shall be evaluated.~      It is being hypothesized that WATSU is related to measurable changes in everyday stress~     perception, psychological wellbeing, quality of life, pregnancy-related low back pain, tonus~     of the uterus, amount of amniotic fluid, spontaneous course of breech presentations,~     prospects of external cephalic versions.~      Participants in the intervention-group will be treated twice with WATSU (60 minutes per~     treatment, standardized sequence) in the >36th week of pregnancy. There will not be any~     sham-intervention in the control-group. Both groups will be examined by ultrasound (prior and~     after the treatments plus on day 8 of the trial) and answer questionnaires (prior and after~     the treatments plus once a week until birth).~   "
142046|NCT01708005|"~     The purpose of this study is to compare the effect after 12 weeks of the oral intake of~     Lecitone®Se + 200UI/day of D3 vitamin with the effect of a placebo on changes in cognitive~     performance in Trial Making Test score part B (this test evaluate executive functions of~     mental flexibility) in older adults with Mild Cognitive Impairment (MCI).~   "
142047|NCT01707992|"~     This is a multinational, multicenter, randomized, double-blind, parallel-group,~     placebo-controlled study followed by active treatment, to evaluate the efficacy, safety and~     tolerability of two doses of oral administration of laquinimod in subjects with RRMS. . The~     study has periods: Period 1, the double-blind, placebo-controlled period (up to 24 months)~     and Period 2, the active treatment period (24 months).~   "
142048|NCT01707979|"~     The aim of the study is to examine the suitability to detect diabetic neuropathy using NIR~     and impedance.~   "
142049|NCT01707966|"~     The main objective of this multicenter, randomized, double-blind, placebo-controlled phase~     III trial is to assess the impact of maintenance orteronel on disease progression and hence~     on quality of life in patients with metastatic castration-resistant prostate cancer who have~     achieved at lease disease stabilization after first line chemotherapy with docetaxel.~   "
142050|NCT01707953|"~     The aim of this study is to examine the efficacy of 5 mg Midodrine (Gutron) vs. placebo on~     reducing the incidence of orthostatic hypotension during mobilization 6 h after a total hip~     arthroplasty.~   "
142051|NCT01707940|"~     This trial investigates the influence of oral ketoconazole on the pharmacokinetics and safety~     of BI 144807.~   "
142052|NCT01707927|"~     Comparing two biological valves in a prospective randomized study. Mosaic Ultra and Trifecta.~     The investigators are looking at EOA and the Pressure Gradients over the valve by patients~     with the same annulus measured by a hegar dilatator.~   "
142053|NCT01707914|"~     Chinese bayberry, one of six Myrica species native to China, is rich in anthocyanins, and~     cyanidin-3-O-glucoside (C3G) was identified as a major anthocyanin component. In previous~     animal studies from us and other investigators, anthocyanins have been shown to ameliorate~     dyslipidemia and hepatic steatosis in different rodent models. The aim of the present study~     was to examine the effects of Chinese bayberry juice (CBJ) on the serum lipid profile and on~     levels of biomarkers related to antioxidant status in young adults with features of fatty~     liver disease.~   "
142054|NCT01707901|"~     A random controlled study to investigate the effect of a new drug, ONO-8539, on oesophageal~     pain hypersensitivity in patients with gastric reflux disease~   "
142055|NCT01707888|"~     Surgery may be the best treatment choice for early stage non-small cell lung cancer. And VATS~     major lung resection have been preferred as a standard radical procedure for early stage~     non-small cell lung cancer (NSCLC).This study aim to investigate the outcome of VATS major~     lung resection for lung cancer as a real-world study in china.~   "
142056|NCT01707875|"~     Fetal brain asymmetry is considered a normal developmental processes. The size and shape of~     the lateral ventricles are interdependence with the brain parenchyma. Abnormal development of~     the fetal brain may cause unilateral or bilateral ventriculomegaly. Fetal cerebral ventricle~     measurement is one of the most frequently used sonographic tool for the evaluation of brain~     development. It is easier to evaluate and measure the distal cerebral ventricle, and~     therefore data concerning the normal range of asymmetry and the normal progress of the~     asymmetry are limited.~      The objective of the study is to follow up the incidental finding of fetal ventricle brain~     asymmetry between 19-30 weeks of pregnancy.~   "
142057|NCT01707862|"~     Intravenous leiomyomatosis (IVL) with intracardiac extension is a rare benign smooth muscle~     tumor. Reviewing literature, intracardiac extension of the IVL has been reported in at least~     70 cases. Most are individual case reports. Surgical experience is not much. However,~     different opinion of surgical strategies remain controversial. The purpose of this report is~     to describe our experience of surgical management for the IVL with intracardiac extension.~   "
142070|NCT01707693|"~     Making physical activity an integral part of daily life is imperative to the health and~     well-being of our nation's older adults. However, no intervention strategy to encourage daily~     physical activity for older adults, especially older women, has been effective. This~     feasibility study will test a multi-tailored motivational intervention to increase usual~     lifestyle physical activity of older sedentary women to reduce their coronary heart disease~     risks.~   "
142071|NCT01707680|"~     The purpose of this study is to determine whether the use of different sedatives affect the~     weaning process from mechanical ventilation in intensive care patients.~   "
142058|NCT01707849|"~     Background:~      Hepatitis C recurrence, which invariably occurs in viremic liver transplant (LT) recipients,~     associated with accelerated liver fibrosis leading to established graft cirrhosis in 40-20%~     of patients in 5 years with another 5% experiencing an aggressive form with cirrhosis and~     graft loss in 1 year. Since treatment after LT has a low efficacy, the overall survival of~     HCV-infected LT recipients is shorter than that of uninfected LT patients.~      New immunosuppressive agents such as mTOR inhibitors (Everolimus/Sirolimus) reduce the risk~     of liver graft rejection, have antifibrotic properties and do not worsen HCV recurrence.~     Moreover new directly-acting antiviral agents have increased efficacy of interferon-based~     treatment but their use in LT recipients may be limited by side effects.~      Hypothesis:~      Use of individualized immunosuppressive regimen and early personalized anti-viral treatment~     based on recipient and viral factors would improve outcome of HCV infected liver transplant~     recipients.~      Objectives:~        1. To evaluate safety and efficacy of two steroid-free immunosuppressive regimens to reduce~          hepatitis C recurrence associated to fibrosis progression (F≥2 under ISHAK score) at one~          year post-transplant.~        2. To identify viral and recipient factors associated with liver fibrosis progression using~          ultra-deep pyrosequencing (UDPS).~   "
142059|NCT01707836|"~     This study will analyze DNA samples to determine associations between maternal and offspring~     genetic factors and pediatric brain tumor development in children with Neurofibromatosis Type~     1. Participating families (mother, father, child) will be asked to complete a short~     questionnaire and provide DNA samples (either saliva or blood). The information gained from~     your participation may one day help doctors develop strategies to reduce brain tumor risk in~     individuals with NF1. Please note: there is no therapy associated with this study.~   "
142060|NCT01707823|"~     This pilot clinical trial studies low-dose acetylsalicylic acid in treating patients with~     stage I-III non-small cell lung cancer. Studying samples of urine and blood from patients~     with cancer in the laboratory may help doctors learn more about changes in biomarkers that~     occur during treatment with acetylsalicylic acid~   "
142061|NCT01707810|"~     METHODS: Patients were submitted to conventional (n=15) or piggyback (n=17) liver~     transplantation (LTx). Free hepatic vein pressure (FHVP) and the central venous pressure~     (CVP) measurements were performed after graft reperfusion. Postoperative (PO) serum~     creatinine (Cr) was measured, acute renal failure (ARF) was defined as Cr > or = 2,0mg/dL and~     PO renal function was analyzed by modificated RIFLE-AKIN. PO overall Cr was calculated by~     area under the curve (AUC) of Cr vs. time. on the first week.~   "
142062|NCT01707797|"~     The study aims to develop a questionnaire that can be used to help uncover a child's risk of~     developing dental caries (also known as tooth decay or a cavity). The aim is to develop a~     practical and easily-scored risk tool that a primary medical care provider can use to help~     find young children with the highest risk for developing cavities.~   "
142063|NCT01707784|"~     The objective of the study is to investigate the effect of stress on glucose tolerance during~     pregnancy.~      The main objectives of the study are to investigate if various measures of stress (stressful~     life events, the perceived level of stress and the cortisol or copeptin concentrations)~     differ between pregnant women with and without gestational diabetes during the end of the~     second/beginning of the third trimester when presenting for their routine glucose tolerance~     testing.~      Secondary objectives are the link between these different stress measures and the routinely~     measured fasting and stimulated glucose levels during the oral glucose tolerance test.~   "
142064|NCT01707771|"~     Objective: to assess the effect of gastric bypass on HDL-cholesterol concentration and its~     Apolipoprotein A4 content at 1 year following bariatric surgery in comparison with a~     hypocaloric diet. Secondary aim was to measure total cholesterol and triglycerides levels as~     well as insulin sensitivity after interventions.~      Summary Background Data: Very few prospective uncontrolled studies have investigated the~     effects of Roux-en-Y gastric bypass (RYGB) on cardiovascular risk factors. No controlled~     studies had as primary goal the changes in HDL-cholesterol after gastric bypass.~      Methods: Forty subjects with a BMI>40 or ≥35 kg/m2 in the presence of diabetes were enrolled.~      Twenty of them were operated of RYGB while 20 received lifestyle modification suggestions and~     medical therapy for obesity complications (diabetes, hypertension and hyperlipidemia).~   "
142065|NCT01707758|"~     The primary objective is to develop a rapid in vitro screening assay for detection of~     pancreatic cancer biomarkers in blood of patients with pancreatic cancer.~   "
142066|NCT01707745|"~     Prospective study to evaluate the efficacy and safety of intravitreal bevacizumab In~     retinopathy of prematurity (ROP).~      Bevacizumab 0.75 mg in 0.03 ml was given to stage 2+ or stage 3+ ROP in Zone I or Zone II.~   "
142067|NCT01707732|"~     Venous thromboembolism (VTE), deep vein thrombosis (DVT) or pulmonary embolism (PE) is a~     common medical condition encountered during hospitalization in a medical environment. The use~     of thromboprophylaxis with Low Molecular Weight Heparin (LMWH) or fondaparinux has reduced~     more than 50% relative risk of thromboembolic complications.However, while obesity defined by~     a body mass index (BMI) greater than 30 kg/m2, is a major risk factor for venous thrombotic~     events, data on obese patients are limited. In fact, less than 20% of patients included in~     the three major studies of preventive medicine had a BMI ≥ 30 kg/m2 and most studies specific~     to the obese population comes from a series of bariatric surgery patients or orthopedic~     surgery. The main results of this series show regarding the obese population a decrease of~     the anti-Xa activity during the administration of a standard dose of enoxaparin (40 mg / d).~     However, no specific recommendation in this population has not been published to date and~     therefore,the dosages currently used are the same regardless of the patient's weight. In this~     context, the use in obese patients hospitalized in a medical environment a stronger dosage of~     enoxaparin (60 mg / d) compared to the standard dose of 40 mg / day, could get rates anti-Xa~     activity levels more consistent with the treatment required, and thus reduce the risk for~     thromboembolic complications in these patients~   "
142068|NCT01707719|"~     High lipid peroxidation and altered antioxidant defenses have been frequently reported in~     Alzheimer's disease patients.~      The purpose of this study is to investigate susceptibility to photo-oxidation of isolated~     erythrocyte membranes, in patients affected by Alzheimer's disease and age- and sex-matched,~     non demented subjects.~   "
142069|NCT01707706|"~     The purpose of this study is to evaluate the clinical effectiveness of acupuncture treatment~     on residual insomnia in major depressive patients.~   "
142073|NCT01707654|"~     A combination of soft tissue and digital nerve defects in the finger results in sensory loss~     of the finger pulp. Reconstruction of these combined injuries is difficult. When the~     neurocutaneous defect is associated with wound infection, reconstructive alternatives are~     more limited. From July 2008 to May 2010, a retrospective study was conducted with 9~     consecutive postinfection patients who had the neurocutaneous defect of the finger following~     trauma. The purpose of this retrospective study is to report repair of the complicated~     infected wound in the finger using the bipedicled nerve flap and to evaluate the efficacy of~     this technique.~   "
142074|NCT01707641|"~     Oral mucositis is a debilitating side effect for oncology patients and there is a clear need~     for new therapeutic options. The lozenges containing Lactobacillus brevis CD2 proved a~     potential new alternative for the prevention of grade III and IV mucositis. The main endpoint~     of this study is to verify if these lozenges taken 6 times a day may reduce the incidence of~     grade III and IV mucositis as well as increase the percentage of patients who will complete~     the radio-chemotherapy treatment.~   "
142075|NCT01707628|"~     The purpose of this study is to compare the number of responders to vaccination with the~     influenza virus vaccine at different time points after last dose of rituximab in patients~     with lymphoma. Secondly to study the immune-response to vaccination with influenza virus~     vaccine, after treatment with rituximab in relation to the reconstitution of immune-function.~   "
142076|NCT01707615|"~     The purpose of this study is to investigate the antiatherogenic effect of GSPE in clinical~     use~   "
142077|NCT01707602|"~     The project aims to evaluate the impact of skin routes of immunization (transcutaneous and~     intradermal vs intramuscular) on cellular and humoral responses to seasonal influenza~     vaccination in adults (18-45 years old).~   "
142078|NCT01707589|"~     the investigators are assessing a non-invasive monitor based on dynamic light scattering that~     measures pulse rate and respiration rate. The monitor also will be equipped with a~     temperature sensor and a motion sensor. This monitor will allow multi-parametric measurements~     in neonates in a simple and noninvasive manner.~   "
142079|NCT01707576|"~     The primary purpose is to estimate the prevalence of depression and subsyndromal states among~     adolescents 13 to 17 years consulting to hospital emergency rooms for any reason, for they~     are another way of tracking this suffering, as they host many troubled teens at once for~     health problems and accidents sometimes iterative, reflecting their risk behaviour.~      Secondary purposes are to assess the feasibility and desirability of a post-emergency medical~     consultation for adolescents who scored high on a self-administered questionnaire, and to~     assess the impact of this approach by later monitoring.~   "
142080|NCT01707563|"~     Marfan syndrome is an autosomal dominant connective tissue disorder caused by mutations in~     the fibrillin-1 gene (FBN1). Penetrance of FBN1 mutations is complete but intra and inter~     familial clinical expressivity is extremely variable. The underlying mechanisms for~     variability are not understood. An interesting mechanism is that the expression level of the~     wild type and/or mutated allele may play a role in the determination of variability.~      Principal objective: To evaluate in Marfan patients, if FBN1 expression level (non-mutated or~     mutated allele) modulates the clinical expression of the disease.~      Judgment criteria : Correlation allelic expression level-phenotype Perspectives : To search~     the predictive factors of severity in order to ameliorate precocity of taking care.~   "
142081|NCT01707550|"~     This observational survey study will capture all renal transplant patients in Serbia who are~     currently receiving CellCept (mycophenolate mofetil) as part of their immunosuppressive~     protocol.~   "
142082|NCT01707537|"~     To Determine the Safety and Immunogenicity of an Oral(Whole Cell) Euvichol Cholera Vaccine in~     Healthy Adult Men~   "
142083|NCT01707524|"~     The aim of this study is to measure radiation exposure during coronary angiography (CA) with~     a trans-radial approach (TRA), specifically comparing access via the left versus right radial~     artery in patients with suggested clinical predictors of TRA failure/difficult. These~     predictors include age >70, female gender, height <64 inches, and history of hypertension.The~     study also aims to determine difficulties encountered during left or right radial access in~     this specific patient population. A secondary aim is to compare the results of enrolled~     patients with a registry of patients where femoral access was obtained.~      Currently more than 1 million percutaneous coronary interventions (PCI) are performed in the~     United States annually. There is a growing trend to perform procedures utilizing the TRA due~     to recent data demonstrating decreased bleeding and access-site complications compared to the~     femoral approach. However, the TRA approach is also know to be associated with greater~     radiation exposure compared to the femoral approach. Furthermore, the TRA to catheterization~     may be difficult in certain populations because of anatomic considerations. Though~     traditionally completed via canalization of the right radial artery (RRA) due to feasibility~     with room setup, left radial artery (LRA) access may be superior due to the shorter distance~     needed to reach the ascending aorta and bypassing the tortuosity of the right subclavian~     artery. Given the benefits of the TRA, it is important to determine how left versus right~     radial artery access affects parameters of radiation exposure in addition to procedural~     difficulty.~      This study will be a prospective, randomized study of patients with suggested predictors of~     TRA failure/difficulty referred for coronary angiography. Patients referred for coronary~     angiography using the trans-radial approach will be randomly assigned to obtain arterial~     access via the right or left radial artery. A registry of patients referred for coronary~     angiography using the trans-femoral approach will be compiled. The primary outcome measure~     will be radiation exposure as measured by dose area product output from the coronary~     angiography system. Secondary measures will include the total fluoroscopy time, total dose of~     radiation, number of catheters used, and incidence of subclavian tortuosity. In addition,~     procedural complications and success rates will also be evaluated.~   "
142084|NCT01707511|"~     Et-C02 is used to predict PaCO2 during surgery. There are controversies regarding the value~     of ETCO2 to predict PaCO2. The aim of this study was to investigate the relation between~     Et-CO₂ and PaCO₂ measurements in patients undergoing laparoscopic colorectal surgery. Patient~     and surgical characteristics, mechanical ventilation adjustments, and intraabdominal pressure~     values and the corelation between these parameters and EtCO₂ - PaCO₂ difference were also~     investigated.~   "
142085|NCT01707498|"~     This is multi-center prospective randomized trial evaluating the effectiveness of a new~     brain-computer interface for communication of quadriplegic patients in a clinical context.~     This performance of this will compared to traditional assistive technology (scanning system)~     and to performance of a healthy volunteer population.~   "
142096|NCT01707355|"~     The poster is effective in improving the level of knowledge regarding dental trauma of~     primary and secondary schools teachers in Hong Kong.~      A cluster randomized controlled trial was conducted in mid May 2011,to test the level of~     knowledge regarding dental trauma with two groups, the intervention group with posters and~     control group without posters. A questionnaire is used to test the level of knowledge.~   "
142097|NCT01707342|"~     The purpose of this study is to evaluate the absolute bioavailability and pharmacokinetics~     (what the body does to the medication) of simeprevir (TMC435) after administration of single~     oral doses of 50 mg and 150 mg when administered together with a single intravenous (IV) dose~     of 100 microgram [3H]-TMC435 in healthy male participants.~   "
142086|NCT01707485|"~     This study will investigate the feasibility of testing whether a 5-day course of antibiotics~     is as effective as a 10-day course for the treatment of uncomplicated community-acquired~     pneumonia (CAP) in children. To accomplish this, previously well children aged 1-10 years who~     present to McMaster Children's Hospital (MCH) emergency department (ED) with CAP will, if~     they consent, be randomly chosen to be given either a 5 day or 10 day course of amoxicillin.~     Neither the child, the child's caregiver, nor the researchers will know whether the child is~     in the 5- or 10-day antibiotic group. Once the child has received the medication and for two~     weeks after that, caregivers of children will be asked to complete a daily symptom diary for~     their child, and will come to MCH at the end of the two week period (between day 14-18) to be~     assessed by one of the researchers. This information will then be used to compare both groups~     of children to determine if a 5 days of treatment is non-inferior to 10 days. The~     investigators hypothesize that running such a trial is feasible.~   "
142087|NCT01707472|"~     This is an open label, exploratory study of simtuzumab (GS-6624) in adults infected with HIV,~     hepatitis C virus (HCV), or co-HIV/HCV with histological evidence of liver fibrosis.~     Participants will receive simtuzumab 700 mg intravenously every 2 weeks for a total of 24~     weeks (12 infusions) while continuing on standard therapy for HIV (HIV-infected subjects~     only).~   "
142088|NCT01707459|"~     This prospective, multicentre, observational study aims to test pre-operative platelet~     function when taking anti-platelet medications. The investigators are using a simple bedside~     blood test called Thromboelastography (TEG) and Platelet Mapping Assay (PMA). The~     investigators will then follow the patient throughout their hospital stay for any major~     cardiac complications (MACE) after surgery (peri-operative). The investigators hope to~     determine if there is an association between how well platelets were inhibited by these drugs~     before surgery and MACE during the perioperative period, 30 day, and one year follow-up.~     Also, the response of various people to anti-platelet medications and their chances of~     getting a major adverse cardiac outcome are determined by their genetic makeup. The~     investigators will try to determine if certain genes are associated with higher cardiac risk.~      Hypothesis: In patients who had percutaneous coronary intervention (PCI) and are undergoing~     non-cardiac surgery (NCS) major adverse cardiac events (MACE) are associated with inadequate~     platelet inhibition.~   "
142089|NCT01707446|"~     Delirium after cardiac surgery is reported in a range of 3-47% of patients. Delirium is a~     serious complication that results in prolonged length of stay, increased health care costs~     and is associated with higher death rates. The exact cause involved in the development of~     delirium after cardiac surgery is unclear. The latest advancement in near-infrared~     spectroscopy (NIRS) Oximetry offers real-time management of patients at risk of brain injury.~     This approved device will monitor cerebral oxygenation during and 24hr after cardiac surgery,~     recording oxygenation in real time allowing the clinical team the opportunity to intervene~     early to prevent ischemia and possibly preventing untoward events. Adverse events followed~     include, but are not limited to, stroke, (transient ischemic attacks), heart attack,~     (myocardial infarction), clots found in lungs (pulmonary embolism), kidney failure,~     pneumonia, cause of death for 30-days after surgery (all cause mortality).~      Hypothesis: Perioperative restoration of rSO2 desaturation to baseline values results in~     lower delirium rates after complex cardiac surgery.~   "
142090|NCT01707433|"~     BACKGROUND/OBJECTIVE: Quantitative urine screening for mucopolysaccharides (MPS) has been the~     primary method for detecting mucopolysaccharidoses in children. This method may not be~     sufficiently sensitive and may miss some patients with arylsulfatase B (ARSB) deficiency.~     Investigators propose to identify patients retrospectively and prospectively who carry a~     diagnosis of spondyloepiphyseal dysplasia, multiple epiphyseal dysplasia, bilateral proximal~     femoral epiphyseal dysplasia, or bilateral Legg-Calve-Perthes. For these patients,~     investigators will perform enzyme testing on a blood sample which will identify MPS VI or~     IVA.~      Patients who have an earlier diagnosis of MPS are likely to have better health outcomes with~     medical management. Therefore, it is important to determine effective diagnostic methods.~     Investigators believe that bilateral hip involvement should alert the clinician to the~     possibility of MPS VI and further examination. The purpose of this study is to test the~     hypothesis that the correct diagnoses of two MPS storage disorders are delayed in patients~     with bilateral proximal femoral epiphyseal dysplasia and normal quantitative urine MPS~     studies.~   "
142091|NCT01707420|"~     The typical post-operative course for children following surgical removal of their tonsils~     and adenoids can be challenging, especially for pain control. First line medications for pain~     include intravenous and enteral narcotics, acetaminophen and nonsteroidal anti-inflammatory~     drugs (NSAIDs) or N-methyl-D-aspartate (NMDA) antagonists but their effects appear to be~     short-lived. Gabapentin has been shown in adult studies to tone down the body's response to~     pain and decreases opioid use post-operatively. The purpose of this study is to see if a~     single preoperative dose will reduce post-operative pain scores and the amount of analgesic~     used.~   "
142092|NCT01707407|"~     1. To evaluate the pharmacokinetics (PK) of pomalidomide administered with the CYP3A4/P-gp~          inhibitor ketoconazole compared with pomalidomide alone in healthy male subjects.~        2. To evaluate the PK of pomalidomide administered with the CYP3A4/P-gp inhibitor~          ketoconazole plus the CYP1A2 inhibitor fluvoxamine compared with pomalidomide alone in~          healthy male subjects.~        3. To assess the PK of pomalidomide administered with the CYP1A2 inhibitor fluvoxamine and~          the CYP3A4/P-gp inhibitor ketoconazole compared with pomalidomide plus the CYP3A4/P-gp~          inhibitor ketoconazole in healthy male subjects.~      Part 2~      1) To evaluate the pharmacokinetics of pomalidomide administered with the CYP3A4 inducer~     carbamazepine compared with pomalidomide alone in healthy male volunteers.~      Secondary Objectives~      1) To evaluate the safety of pomalidomide in Part 1 and Part 2 when administered with~     ketoconazole, fluvoxamine and/or carbamazepine.~      In addition: To evaluate the safety of pomalidomide in Part 1 and Part 2 when administered~     with ketoconazole, fluvoxamine and/or carbamazepine.~   "
142093|NCT01707394|"~     CV185118 is a single dose Apixaban PK/PD study in pediatric subjects. The objective of this~     study is primarily to study the PK/PD of Apixaban in pediatric subjects at risk for~     thrombosis~   "
142094|NCT01707381|"~     This clinical investigation is being performed to compare the effect of BOL-303259-X dosed~     once daily (QD) with timolol maleate 0.5% dosed twice daily (BID) in reducing intraocular~     pressure (IOP) measured over a 24-hour period in subjects with open-angle glaucoma (OAG) or~     ocular hypertension (OHT).~   "
142098|NCT01707329|"~     This phase II randomised, double blind, placebo controlled, multicentre trial is designed to~     assess the efficacy and safety of continuous icotinib plus chemotherapy versus chemotherapy~     alone in patients who have progressed after benefiting from previous second or third-line~     icotinib treatment (more than 6 months) in locally advanced or metastatic non-small cell lung~     cancer.~   "
142099|NCT01707316|"~     The purpose of this study is to evaluate the pharmacokinetics (what the body does to the~     medication) and pharmacodynamics (the action of the medication on the body) of JNJ-28431754~     (canagliflozin) and its main metabolites (break-down products) following 2 different doses of~     canagliflozin in healthy Chinese volunteers. Safety and tolerability of canagliflozin will~     also be assessed.~   "
142100|NCT01707303|"~     This is a randomized, controlled, pilot study of two separate Cohorts of patients from the~     intensive care unit. Cohort I will enroll 50 patients and randomize to receive one physical~     therapy session per day or receive usual ICU care. Cohort II, will enroll an additional 50~     patients and randomize to receive either two physical therapy sessions per day or usual care.~     Outcome will be length of hospital stay measured in days. Secondary outcomes will be~     mortality, ventilator days, ICU days, and for Cohort II, grip strength, dynamometer strength~     assessments and the short physical performance battery (SPPB). Study subjects will have blood~     for cytokine analysis through their first week of study.~   "
142101|NCT01707290|"~     The purpose of this study is to evaluate the safety of long-term ivacaftor treatment in~     participants with cystic fibrosis (CF) from Studies 110 (NCT01614457), 111 (NCT01614470), and~     113 (NCT01685801).~   "
142102|NCT01707277|"~     Previous studies have evaluated the effects of inspiratory muscle training in patiens with~     heart failure and reduced ejection fraction; nevertheless,no evidence endorse the therapeutic~     role of inspiratory muscle training in patients with heart failure and preserved ejection~     fraction. The investigators sought to evaluate whether 12-week inspiratory muscle training~     improves exercise capacity (peak exercise oxygen uptake and 6-minutes walk test), as well as~     left ventricular diastolic function, serum biomarkers and quality of life (Minnesota Living~     With Heart Failure Questionnaire) in patients with heart failure with preserved ejection~     fraction and non-reduced inspiratory muscle strength.~   "
142103|NCT01707264|"~     Dose escalation study to determine the maximum tolerated dose of NEOD001 in approximately 30~     subjects with AL amyloidosis. Expansion phase to evaluate safety, efficacy and~     pharmacokinetics of NEOD001 in 25 additional subjects at the maximum tolerated dose.~   "
142104|NCT01707251|"~     Primary objective of this study is to test hypothesis that IV ibuprofen decreases 24 hours~     morphine requirement using IV PCA in patients after laparoscopic bariatric surgery. Secondary~     objective is to determine if it decreases respiratory depression measured using RD, improves~     area under curve (AUC) for pain scores at rest (AUCr) and with cough (AUCa) and pressure pain~     threshold (PPT) (important for mobilization). Tertiary objective is to compare incidence of~     nausea/vomiting, sedation, itching, blood transfusion, over sedation, urinary retention, GI~     or surgical bleeding, renal dysfunction, time to clears and baseline activity in ibuprofen~     and control groups.~   "
142105|NCT01707238|"~     The purpose of this study is to compare the subjective performance for handling of two daily~     disposable contact lenses, stenfilcon A and etafilcon A.~   "
142106|NCT01707225|"~     The investigators hypothesize that octreotide LAR (Long Acting Release) safely decreases GI~     bleeding in patients with a left ventricular assist device (LVAD). Patients undergoing~     implantation of non-pulsatile, continuous-flow LVAD have a higher incidence of~     gastrointestinal bleeding. This is a significantly associated morbidity and can threaten a~     patient's life as well as their ability to undergo eventual heart transplantation secondary~     to both general health/strength and the potential development of antibodies to blood products~     that would make future transfusions and transplantations more difficult.~      If this research finds that use of octreotide LAR can decrease the incidence of~     gastrointestinal bleeding in this patient population, it will revolutionize the manner in~     which these patients are managed. The finding of reduced GI bleeding would allow the patient~     to have less exposure to blood products, reduce hospitalizations, and ensure that subsequent~     transplant planning not be delayed. This would not only be of great benefit to the patient,~     but would significantly decrease health-care costs through preventive measures.~      The goal of this project is to study whether the regular administration of monthly octreotide~     LAR is safe and if it will decrease the incidence of gastrointestinal bleeding in patients~     undergoing implantation of non-pulsatile, continuous flow left ventricular assist devices~     (LVAD).~   "
142107|NCT01707212|"~     There are numerous pain management strategies available for the management of infant~     immunization pain. The majority of infants, however do not benefit from these interventions,~     which causes them to suffer pain unnecessarily. This study will assess the impact of~     educating parents about pain management strategies on their knowledge and behaviour regarding~     pain management during routine 2-month infant immunization injections.~   "
142108|NCT01707199|"~     In Afghanistan, studies over the past 15 years have shown a high degree of Plasmodium~     falciparum resistance to chloroquine. In 2003 the high failure rate of chloroquine against~     falciparum malaria led the national malaria treatment programme to switch its recommended~     first line drug treatment for uncomplicated Plasmodium falciparum malaria to~     artemisinin-based combination therapy (ACT) in the form of~     Artesunate/Sulphadoxine-Pyrimethamine (AS+SP). Second line drug treatment is oral quinine (7~     days).~      For operational reasons, prior to recent studies (manuscript in preparation) there have been~     no molecular data on P. falciparum SP resistance markers from within the borders of~     Afghanistan. These studies have revealed early evidence of increasing SP resistance~     (resistance polymorphisms with double DHFR & triple DHPS mutations). The aim of this study is~     to conduct a focused, prospective study in Kunar for monitoring of the efficacy of the AS+SP~     combination in this province, along with molecular studies of isolates from recruited~     patients.~   "
142147|NCT01706692|"~     The purpose of this study is to evaluate the long-term course of patients with psoriasis and~     psoriatic-arthritis in systemic treatments such as, methotrexate, cyclosporin A, fumaric~     acids, acitretin, systemic PUVA, etanercept, infliximab, adalimumab and ustekinumab. A~     patient will be included at first initiation of the treatment and will remain in the registry~     for 5 years, regardless of subsequent therapy.~      The registry will also evaluate safety clinical outcomes and health related quality of life.~   "
142109|NCT01707186|"~     PRISM (Pictorial Representation of Illness and Self Measure) has been developed since the~     mid-1990s; the task was first developed as a simple measure of how a person was coping with~     his or her experience of illness. This is an international, multicentre study to evaluate the~     PRISM tool for the assessment of suffering in rheumatoid arthritis at different stages of the~     illness and the effect of treatment intervention. There are 5 sites: Berlin, Oxford, Limoges,~     Montreal and Queensland. The study will recruit 200 patients in total.~      In addition to the procedures for the patient's routine clinical visit, the patients will be~     invited to answer a series of questionnaires and donate 20ml blood sample. Patients will be~     asked to attend 3 times over 24 weeks~   "
142110|NCT01707173|"~     This is a research study of African American parents/caregivers of newborns. The purpose of~     this research study is to learn what type of educational materials about infant safety and~     safe infant sleep are most effective and acceptable to parents and caregivers. The~     investigators will compare the responses of parents who receive enhanced materials to the~     responses of parents who receive the ordinary materials that are currently in use.~   "
142111|NCT01707160|"~     This trial is conducted in Europe. The aim of this trial is to investigate the~     pharmacokinetics and pharmacodynamics of insulin X14 30/70 PreMix compared to human insulin~     30/70 PreMix in healthy volunteers.~   "
142112|NCT01707147|"~     The aim of this study is to monitor safety and efficacy of treatment with linagliptin in~     Korean patients with type 2 diabetes mellitus in routine clinical settings.~   "
142113|NCT01707134|"~     This trial is conducted in Europe. The aim of this trial is to evaluate the safety profile of~     insulin aspart in subjects with type 1 diabetes having participated in trial ANA/DCD/035.~   "
142114|NCT01707121|"~     Over the last decades different life style factors have been established as risk factors for~     various diseases. The obesity pandemic displays a good example of a disease where great~     effort is undertaken to characterize risk factors associated with obesity (1). Smoking is~     another life style risk factor established since several decades, and where primary~     prevention has been increasingly successful (2, 3). Cardiovascular epidemiologic research at~     the University of Gothenburg recognized PA as a factor of importance early on and thus~     included PA related questions in the work up of studies with large cohorts (4-6). A 4-level~     scale was introduced in the late 1960:s by Saltin and Grimby (7) and has been used~     extensively since then. With this background it is of interest to record physical activity~     one year and one month prior to certain types of elective surgery and to study the~     relationship of PA to surgical complications and recovery is of interest.~      The aim of this study is to investigate whether a higher physical activity prior to a~     surgical procedure reduces hospital stay, sick leave and the complication rate.~      A secondary aim is to investigate the effect of preoperative physical activity on the rate of~     resumption of QoL and normal physical function.~   "
142115|NCT01707108|"~     The aim of the present study is to evaluate the 1-year and 3-year survival and success of~     MIS® C1 implants with a length of 10-15mm.~      Specific Aims~        1. To study 1-year and 3-year implant survival rate C1 implants~        2. To study 1-year and 3-year implant bone level changes of C1 implants~   "
142116|NCT01707095|"~     Electrosurgery is used in virtually every laparoscopic operation performed. Capacitive~     coupling is a common electrosurgery complication. Previous work biopsying the skin adjacent~     to laparoscopic port sites is a method to determine if capacitive coupling thermal injury to~     the skin occurs during a laparoscopic operation. [Willson et al. Surg Endosc (1997) 11:653]~     In our previous study, COMIRB 09-0049, we found thermal injury at 55% of umbilical trocar~     site skin biopsies and 35% of epigastric trocar site skin biopsies following laparoscopic~     cholecystectomy. Our benchtop research compared bundling of the camera cord with the active~     electrode cord versus unbundling of the camera cord with the active electrode cord and found~     a 59% decrease in heat generated in the unbundling experimental set-up. [Jones, EL, Robinson,~     TN, et al. Surg Endosc (2012) Epub.]~      This study plans to compare thermal injury which occurs during two commonly used operating~     room set-ups. First, laparoscopic cholecystectomy with bundled camera/active electrode cords.~     And second, laparoscopic cholecystectomy with unbundled camera/active electrode cords. The~     primary outcome is the incidence of thermal injury at the skin adjacent to the camera port~     site (the umbilical port) that will be diagnosed by histology.~   "
142117|NCT01707082|"~     Part A of the study will test the safety, the amount of drug in the body, and effects of the~     drug in the body after multiple doses. This will be conducted in healthy overweight adults.~     Part B of the study will test the effects of multiple doses of the investigational drug on~     the amount of midazolam, an approved drug, in healthy adults.~   "
142118|NCT01707069|"~     This is a research study of a vaccine for allergy to Japanese Red Cedar. The vaccine is~     called CryJ2-DNA-LAMP Plasmid vaccine. This research study will determine how the vaccine is~     tolerated and how research participants respond to the vaccine in various doses.~     CryJ2-DNA-LAMP Plasmid vaccine is investigational, which means it is not approved for use by~     the United States Food and Drug Administration (FDA) but is available in research studies~     like this one. This is the first time that CryJ2-DNA-LAMP Plasmid vaccine is being given to~     humans.~      The purpose of this study is to evaluate the safety of an investigational vaccine intended to~     treat allergy to Japanese red cedar. The vaccine is composed of DNA, which is the material~     that cells use to provide instructions to make proteins. The DNA carries the information~     necessary to make a special protein which is a combination of a protein found in all cells,~     LAMP (lysosomal associated membrane protein), and the protein from Japanese red cedar that~     causes the allergy known as Cry J2. This vaccine is intended to help re-educate the immune~     system with respect to how it will respond to naturally occurring red cedar allergen and~     eliminate the allergic symptoms. Another purpose of this study will be to document the immune~     response to the vaccine~      Subjects that are eligible to participate in this study will be assigned by whether they are~     sensitive or non sensitive to CryJ2 or Mountain Cedar and chance (like flipping a coin) to~     one of 3 study vaccine groups:~      Group 1: will receive four (4) 4-milligram doses of the study vaccine. Group 2: will receive~     four (4) 2-milligram doses of the study vaccine. Group 3: will receive four (4) 4-milligram~     doses of the study vaccine.~      The study vaccine is administered as an intramuscular injection. Enrolled subjects will~     receive the study vaccine every 14 days (at day 0, 14, 28 and 42). Subjects will know their~     study vaccine assignment. Participants who are not allergic to Japanese red cedar will be~     assigned to Group 1. Participants who do have an allergy to Japanese red cedar or Mountain~     Cedar will have an equal chance of being assigned to Group 2 or 3.~      There will be between 18 to 30 men and women participating in the study at one location. Your~     participation in this study will last approximately 72 days.~   "
142144|NCT01706731|"~     This research is to study the effectiveness of cognitive behavioral therapy-CBT and~     Psychotherapy by trained buddhist monks. There are generally accepted that both cognitive and~     Buddhist concepts are related. This randomized controlled trial is to study the elderly~     participants who suffer major depressive disorder according to DSM-IV. The subjects will be~     divided into two groups. The experimental group will receive 12 sessions of CBT 2 times per~     week for 6 weeks in addition to usual treatment. The control group will receive treatment as~     usual and general conversation (non-CBT) with monks. Pretreatment factors (such as attachment~     style, interpersonal factors) of both therapist monks and patient participants will be~     studied.~   "
142119|NCT01707056|"~     The purpose of this study is to evaluate whether taking thyroid hormone medication with~     beverages other than water, decreases absorption of the medication by the intestine.~     Specifically we are interested in whether coffee, coffee with milk, or black tea affects how~     thyroid medication is absorbed by the body. Previous studies have suggested that taking~     thyroid hormone with coffee may interfere with the ability to absorb thyroid medicine. Given~     that many patients take their thyroid medicine with beverages other than water, and~     specifically with coffee or tea, understanding whether and how much coffee or tea may~     decrease thyroid hormone absorption is important for clinical practice.~      This study will help determine the safest and most effective way for adults to take their~     thyroid medication and will guide medical practitioners in how to counsel their patients when~     they prescribe thyroid hormone.~   "
142120|NCT01707043|"~     This is an open label, investigator-blinded, cross over, prospective, single center study of~     subjects with plaque psoriasis. Taclonex® (calcipotriene 0.005% and betamethasone~     dipropionate 0.064%) Ointment and Taclonex Scalp® (calcipotriene 0.005% and betamethasone~     dipropionate 0.064%) Topical Suspension will each be applied topically once daily.~      The primary objective is to assess the patient preference for Taclonex® (calcipotriene 0.005%~     and betamethasone dipropionate 0.064%) Ointment compared to Taclonex Scalp® (calcipotriene~     0.005% and betamethasone dipropionate 0.064%) Topical Suspension in the treatment of plaque~     psoriasis.~   "
142121|NCT01707030|"~     Many people who are infected with Hepatitis C misuse alcohol, which is even more dangerous~     for them than it is for a non-infected person. In this VA study, such individuals will be~     screened and given feedback on their drinking using an Internet-based program which has been~     shown to reduce drinking in other populations. The research team will evaluate whether the~     program helps Veterans drink less over time and thereby improve their health.~   "
142122|NCT01707017|"~     The purpose of this study is to compare the impact of high- and low-intensity resistance~     exercise on force-velocity characteristics, muscle mass and inflammatory processes in older~     adults. As all training protocols are designed to end with maximal effort, effects are~     expected to be similar between groups.~   "
142123|NCT01707004|"~     This phase II trial studies how well decitabine and total-body irradiation followed by donor~     bone marrow transplant and cyclophosphamide works in treating patients with relapsed or~     refractory acute myeloid leukemia. Giving decitabine and total-body irradiation before a~     donor bone marrow transplant helps stop the growth of cancer cells. It may also stop the~     patient's immune system from rejecting the donor's stem cells. When the healthy stem cells~     from a donor are infused into the patient they may help the patient's bone marrow make stem~     cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells~     from a donor can make an immune response against the body's normal cells. Giving decitabine~     and total-body irradiation before the transplant together with high-dose cyclophosphamide,~     tacrolimus, and mycophenolate mofetil after the transplant may stop this from happening.~   "
142124|NCT01706991|"~     The purpose of this project is to compare the performance of the Pediatric Vision Scanner~     (PVS) with the Gold Standard Examination to determine the effectiveness of the PVS at~     detecting amblyopia and strabismus. All tests and observations will be done at a single visit~     over the course of approximately 30 minutes.~   "
142125|NCT01706978|"~     This Clinical Trial is being conducted to study two adjunctive treatments for rotator cuff~     repair; soft tissue and bone trephination. Trephination is a procedure that involves making~     small perforations either in the torn tendon near its edge, or in the bone that the tendon is~     repaired to. The rotator cuff is repaired by sewing the tendon down to the bone in the~     shoulder. Trephination is a new technique that is used in addition to the standard method of~     repairing the rotator cuff tendon.~      This study will help to determine whether this technique improves the speed of healing, the~     strength and the re-tear rate of the repair. You are being asked to take part in this study~     because you have a tear of the rotator cuff that requires surgical treatment. A total of 90~     participants will participate in this study.~   "
142126|NCT01706965|"~     Rater blinded trial of six weeks of Kuvan vs. multivitamin in 60 outpatients with~     schizophrenia or schizoaffective disorder. The aims are to evaluate an anticipated clinical~     response to Kuvan treatment including negative symptom and cognitive deficits, evaluate~     safety of Kuvan treatment for schizophrenic patients and evaluate the relationship of changes~     in plasma Kuvan levels and efficacy outcomes.~   "
142127|NCT01706952|"~     The purpose of our study is to assess the effect of topical vasoconstriction (cocaine 4%~     versus adrenaline 1/1000) on the surgical field during endoscopic sinus surgery.~   "
142128|NCT01706939|"~     This trial aims to directly compare a reduced radiation dose to the standard of care in~     HPVOPC for non-inferiority, thus allowing for direct comparison of outcomes between the two~     groups. The study hypothesis is that LRC and PFS at 3 years for reduced dose CRT are~     non-inferior to standard dose CRT.~   "
142129|NCT01706926|"~     The primary objective of this study is to evaluate the efficacy of 3 subcutaneous doses of~     mavrilimumab compared with placebo in combination with methotrexate (MTX) in subjects with~     moderate-to-severe adult onset Rheumatoid Arthritis (RA).~   "
142143|NCT01706744|"~     The main goal is to investigate the following topics:~        1. Can discharge via the Intermediate Care Unit in Stjørdal, compared to direct discharge~          to Verdal Municipality, be equally effective in preventing aggravation of disease and~          loss of function for patients over 60 years that have been hospitalized in Levanger~          hospital?~        2. Are the cost by discharge to the Intermediate Care Unit in Stjørdal, when the hospital~          is not located in the same Municipality, comparable to the cost by direct discharge to~          the Municipality of Verdal, for patients over 60 years that have been hospitalized in~          Levanger hospital?~        3. Which issues are considered important by patients and health personnel during discharge,~          arrival and follow up in the Municipality, to ensure an optimal interaction between the~          involved units.~   "
142145|NCT01706718|"~     Dietary nitrate is known to lower blood pressure. Beetroot is a rich source of nitrate and~     could therefore be an important dietary component in the management of hypertension and~     cardiovascular disease, however consumption is relatively low. We evaluated the effects of~     beetroot enriched bread ingestion on acute microvascular reactivity, arterial stiffness and~     blood pressure response in healthy men.~   "
142148|NCT01706679|"~     To evaluate the effect of maximum therapeutic and supratherapeutic doses of ATX-101 treatment~     on Fridericia's corrected QT interval (QTcF).~   "
142130|NCT01706913|"~     This is a randomized, controlled study to compare patients evaluated and managed by internal~     medicine hospitalists alone versus patients who are additionally evaluated by a dermatologist~     when they are admitted to the hospital, aiming to demonstrate that hospital admissions for~     cellulitis that involve early dermatology consultation will reduce hospital length of stay,~     readmission rates, prevalence of pseudocellulitis, cost, and antibiotic usage. The hypothesis~     of this study is that obtaining inpatient dermatology consultations, within 24 hours of a~     patient being admitted to the hospital for cellulitis, will reduce the length of stay,~     readmission rate, cost, and antibiotic usage of the patient‟s admission as well as properly~     evaluate and diagnose patients with pseudocellulitis. The primary objective will be to~     measure the difference in the length of stay for patients who are randomized to a dermatology~     consultation within 24 hours of hospital admission (active arm) versus being managed by an~     internal medicine hospitalist alone, as is the standard of care (control arm). The length of~     stay for each arm will be assessed once the study has been completed. The secondary endpoint~     will be to measure readmission rates for cellulitis after patients are discharged from the~     hospital. An additional endpoint will be to determine if antibiotic usage differs between~     patients randomized to a dermatology consultation and those not. Exploratory analyses will~     assess the percentage of patients with a concomitant known predisposing factor for recurrent~     cellulitis such as lymphedema, leg ulceration, tinea pedis, or onychomycosis, as well as the~     association of fever >100.5 F and a history of a prior episode of cellulitis.~   "
142131|NCT01706900|"~     Incubator temperature is one of the most precious variables in IVF labs. When the IVF~     started, almost all incubator temperatures were set at 37 degrees which mimic in vivo~     conditions. Some authors speculated that gametes and early embryos might need low~     temperatures that provide quieter metabolism. We decide to compare Embryo culture at 37~     degree or slightly lower 36.5 degree and extensively investigate to find which is better to~     crucially introduce a solid evidence through this RCT.~   "
142132|NCT01706887|"~     Nedd4.2 is a regulator of ENac, a transporter of sodium involved in the regulation of salt~     retention by the kidney. The study address the consequence of a frequent genetic variation~     leading expected to impact the function of Nedd4 and in turn, the ability of kidneys to~     excrete salt intake. Our hypothesis is that the genetic variants of Nedd4.2 could constitute~     a genetic predisposition to (or protection against) salt-sensitive hypertension.~   "
142133|NCT01706874|"~     The purpose of this study is to assess the impact of an intervention (scaled every 06 months~     associated with the use of mouthwash with essential oils (toothpaste and Listerine® 2 times /~     day containing polymer Triclosan (Colgate Total®)) on the activity of rheumatoid arthritis~   "
142134|NCT01706861|"~     The objective of the study is to actively gather additional information on safety, device~     performance and possible emergent risks following the use of Celotres in a post-market~     setting when used to reduce the recurrence rate, volume, appearance and/or symptoms~     associated with keloid scarring in subjects undergoing surgical excision of keloids as~     compared to the scientific literature.~   "
142135|NCT01706848|"~     The objective of the study is to actively gather additional information on safety, device~     performance and possible emergent risks following the use of Celotres in a post-market~     setting when used to improve wound healing and the resulting scar consequences following~     suturing of a wound.~   "
142136|NCT01706835|"~     This is a phase 1 open-label study to investigate the pharmacokinetics of aldoxorubicin~     administered as a 30 minute infustion every 3 weeks for up to 8 cycles in subjects with~     advanced solid tumors.~   "
142137|NCT01706822|"~     To evaluate the Radial Reload Stapler during laparoscopic low anterior resection (LAR) or~     anterior proctosigmoidectomy for rectal cancer by assessing the primary and secondary~     endpoints.~   "
142138|NCT01706809|"~     The primary aim of the present study is to investigate different biomarkers like VEGF, EVGF~     and others ability to predict time to recidive and progressions free survival.~   "
142139|NCT01706796|"~     The primary purpose of this study is to estimate the relative bioavailability and food effect~     of PF-06273340 tablets.~   "
142140|NCT01706783|"~     This trial is conducted in Europe. The aim of the trial is to investigate the safety,~     tolerability, availability and distribution in the body of once-weekly long-acting growth~     hormone (NNC0195-0092, somapacitan) compared to once daily Norditropin NordiFlex® in adults~     with growth hormone deficiency (GHD).~   "
142141|NCT01706770|"~     The primary objective of thes study is to confirm that the ocular response to the Test lenses~     are similar to those of the Control lenses when used in a 1 week planned replacement, daily~     wear modality over a 1-month period.~   "
142142|NCT01706757|"~     The ability to walk is one of the fundamental attributes of human beings. However, with~     advancing age this ability is modified by a combination of physiological and pathological~     aging.These changes mainly involve an irregularity of the pitch, reducing the length of the~     stride, instability and a decrease in walking speed (Beauchet et al., 2002). Tinetti,~     Speecheley, Ginter (1988, from Ch Wider, F. Vingerhoets, J Bogousslavsky, 2005) show that~     20-30% of heathly older fall each year and state that one of these falls, 25% result in~     injuries with significant effect and 5% a fracture. In addition to the risk of fracture fear~     of falling exists in many older people even before a drop in effective (Recommandation of~     HAS, 2005).In France, about 9 000 deaths of people aged over 65 are associated each year with~     a fall and this association increases rapidly with advancing age in both sexes. It is~     therefore important in terms of public health, learn to recognize the gait disturbance, to~     prevent and to make adequate assessments to reduce the risk of falls. Tools exist to assess~     the risk of falling. Some are comprehensive but time-consuming and are generally discarded in~     favour of other simpler tests (test of Tinetti or get up and go test). However, the listing~     of these lacks precision, particularly in terms of duration single timer.To overcome these~     biases, innovative technology solutions seem to be a good way. In this study, the~     investigators will use the motorized go-cart developed by INRIA, entitled ANG (for Assisted~     Navigation Guide), to obtain more reliable and accurate measurements of parameters such as~     walking speed and direction. Thus, the investigators set the main objective, to compare a~     standard evaluation of the process to a technology assessment, in participants aged 65 to 86~     years. And as secondary objectives : evaluate the acceptance of using go-cart ANG in the~     elderly, develop an index of walking and test the feasibility of detecting a weakness of the~     knee joint by ANG undetected at clinic.~   "
142146|NCT01706705|"~     The goal of this clinical research study is to learn if computed tomography (CT) and magnetic~     resonance imaging (MRI) images can better help to plan internal radiation treatment.~   "
142174|NCT01706341|"~     The purpose of this study is to investigate the effect of administering a small dose of~     glucose on the pregnant women and their neonates during cesarean section. We investigate the~     safety and efficacy of use of a glucose-containing solution for the pregnant women and the~     neonates.~   "
142149|NCT01706666|"~     This randomized phase II trial studies how well giving bortezomib with or without combination~     chemotherapy works as consolidation therapy in patients with newly diagnosed multiple myeloma~     who have completed stem cell transplant. Bortezomib may stop the growth of cancer cells by~     blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as~     cyclophosphamide, dexamethasone, and lenalidomide, work in different ways to stop the growth~     of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet~     known whether giving bortezomib is more effective with or without combination chemotherapy in~     the post transplant setting.~   "
142150|NCT01706653|"~     The purpose of this study is to determine whether consumption of the active product affects~     postprandial changes in metabolic indices, in comparison to the control product.~   "
142151|NCT01706640|"~     This study is Open- Label, Observational, Prospective, Real-time data capturing of Usage,~     Outcome & Physician satisfaction of Coseal in Cardio- Vascular-Thoracic Operative and Re-~     Operative procedures.~      Objective of this study is to assess current practice pattern and best practice sharing of~     usage of Coseal by collecting data on (1) Sealing suture lines along arterial and venous~     reconstruction(2) Patients undergoing cardiac surgery to prevent or reduce the incidence,~     severity and extent of post surgical adhesion enforcement of suture lines in lung resection~     procedures (3) From this data to document and generate a real life experience on the use of~     Coseal in cardio vascular and thoracic surgery.~      Number of expected patient enrollment is 750 from 20 participating sites.~   "
142152|NCT01706627|"~     Meta-analysis of previous studies have shown that melatonin is a beneficial adjutant for~     reducing chemotherapy-induced toxicity; however no randomized, double-blind, placebo~     controlled trials have been conducted. This study evaluates the effect of melatonin in~     improving quality of life and reducing chemotherapy-induced toxicity in advanced cancer~     patients. This is a multi-center, randomized, double-blind, placebo controlled trial~     conducted in patients with histologically proven advanced non small cell lung, breast, head~     and neck or sarcoma cancer. Mixed-block randomization, stratified by center and treatment~     scheme is used to divide eligible patients into three groups: melatonin 20 mg, 10 mg or~     matched placebo. The patients are required to take the studied drugs at night (after 21.00~     pm) on the first day of chemotherapy and continue daily for six months. Standard treatment is~     chemotherapy according to each center's standard protocol. Study endpoints are QOL (FACT),~     adverse event frequency (CTCAE), oxidative stress status, melatonin level, and survival.~   "
142153|NCT01706614|"~     Investigation of biochemical and genetic markers in liver disease that might have an~     influence on the course of the disease~   "
142154|NCT01706601|"~     Hemorrhoids is the most common disease in rectum with a prevalence of 30 % of population.~     This means that many patients are referred to surgical specialist reception with diagnosis~     hemorrhoidal disease. The aim of this study is to describe population of patients with~     hemorrhoidal disease that are referred to a specialised colorectal unit and to determine what~     treatment they are given at a general practitioner as well as in colorectal unit.~   "
142155|NCT01706588|"~     This is a prospective, randomised, double-blind, placebo-controlled, parallel group study in~     approximately 75 patients undergoing surgical removal of an impacted lower third molar.~   "
142156|NCT01706575|"~     This open-label, single-arm, multicenter study will evaluate the efficacy and safety of~     adding Pegasys (peginterferon alfa-2a) to nucleos(t)ide analogue (NAs) treatment in~     participants with HBeAg-negative chronic hepatitis B genotype D showing stable HBV DNA~     suppression. After a 12-week Lead-in period on treatment with NA, participants with a HBsAg~     decline <0.5 log10 IU/ml will enter the Add-on period to receive Pegasys 180 mcg~     subcutaneously weekly for 48 weeks in addition to their current NA treatment. Follow-up will~     be a further 48 weeks, during which the participants will continue their NA treatment.~   "
142157|NCT01706562|"~     The purpose of this study is to investigate the overall success rate of itraconazole~     intravenous treatment for a period of more than 7 days.~   "
142158|NCT01706549|"~     Patients undergone either laparoscopic or vaginal hysterectomy will called for a clinical~     examination 1-3 years after surgery, if they suffer from pain 6 months after surgery. The~     aims of the study are:~        1. to reveal whether the pain is postsurgical in nature, or if there are any other reasons~          for the pain.~        2. to reveal the type of pain, neuropathic, nociceptive or idiopathic.~        3. to reveal the impact of pain on quality of life.~   "
142159|NCT01706536|"~     This is a randomized, double-blind, placebo-controlled, parallel arm study. The study~     population will consist of subjects, 35 to 75 years of age, with a diagnosis of moderate to~     severe COPD per Global Initiative for Chronic Obstructive Lung Disease guidelines.~   "
142160|NCT01706523|"~     This is an open-label extension protocol that will provide necessary data on the safety,~     tolerability, pharmacokinetics and efficacy of STX209 among subjects with ASD.~   "
142161|NCT01706510|"~     Assess the pharmacodynamic effect of ticagrelor vs. Clopidogrel in American Indian patients~     with stable coronary artery disease.~   "
142162|NCT01706497|"~     The postoperative period after congenital heart surgery in children can be a very critical~     episode, where it is of utmost importance to closely monitor the circulation in these~     patients. Invasive hemodynamic monitoring tools available in the adult population, are often~     not suitable to use in small children.~      The Fore-Sight(TM) is a non-invasive monitor for brain tissue oxygenation (SctO2), by~     projecting harmless near-infrared light trough the skin, skull, and brain via a disposable~     sensor that is applied on the forehead of patients. In many centres, the Fore-Sight (TM) is~     part of the routine monitoring of children during cardio-pulmonary bypass for congenital~     heart surgery. Although the monitor has not been tested for this purpose, it is often~     continued in the postoperative phase in the intensive care unit (ICU), where it is used to~     monitor the hemodynamic situation of the patient.~      The purpose of the present study is to examine and validate the use of the Fore-Sight monitor~     for hemodynamic monitoring of children in the postoperative phase after cardiac surgery.~      The study hypothesis is whether SctO2 desaturations are predictive for future hemodynamic~     deterioration of the patient, and whether these SctO2 desaturations are predictive for the~     outcome of these patients.~   "
142163|NCT01706484|"~     The purpose of this trial is to determine whether 2 different dosages of a herbal extract~     (240 and 480 mg/day) are more effective than placebo in the treatment of patients with~     chronic rhinosinusitis (average reduction of investigator's Major Symptom Score over Visit 5~     and Visit 6.~   "
142164|NCT01706471|"~     Calcineurin inhibitors, such as cyclosporine and tacrolimus, have improved allograft survival~     in kidney organ transplantation. Indeed, they have reduced the incidence of acute rejection~     episodes of cadaveric allograft recipients. Although marked progression has been made in~     initial survival rates, long-term kidney graft survival has yet to show such encouraging~     results. Because CNIs are associated with adverse effects, particularly nephrotoxicity, which~     contribute to declining organ function and eventual graft loss. In kidney transplants,~     progressive allograft dysfunction has been shown to develop in as many as 94% of patients by~     1 year.~      Therefore, reducing or eliminating the dose of CNIs to minimize nephrotoxicity must be~     balanced against the maintenance of adequate immunosuppression.~      Certican allows CNI dose reduction then provides renal function improvement and current PSI~     strategy point out that early intervention is important in managing the risk of CAN before it~     develops in both de novo and maintenance renal transplant recipients.~      To demonstrate Certican early introduction after 1 month provides better renal function with~     no change of efficacy compared to standard regimen, and also prevent delayed wound healing.~   "
142165|NCT01706458|"~     This randomized pilot clinical trial studies sipuleucel-T with or without deoxyribonucleic~     acid (DNA) vaccine therapy in treating patients with prostate cancer that has not responded~     to previous treatment with hormones and has spread to other places in the body. Vaccines may~     help the body build an effective immune response to kill tumor cells. It is not yet known~     whether giving sipuleucel-T vaccine works better with or without DNA vaccine therapy in~     treating prostate cancer.~   "
142166|NCT01706445|"~     To study the effects of an 8-week combined inspiratory muscle training and exercise~     (resistance+aerobic) program on of a lung volume, inspiratory muscle strength (maximal~     inspiratory pressure, PImax) and cardiorespiratory fitness (maximal oxygen uptake, VO2peak)~     (primary outcomes)and dynamic muscle strength, body composition and quality of life (QoL) in~     children with Cystic Fibrosis (CF) (secondary outcomes).~   "
142167|NCT01706432|"~     This pilot clinical trial studies hypofractionated image guided radiation therapy in treating~     patients with stage IV breast cancer. Radiation therapy uses high energy x rays to kill tumor~     cells. Giving radiation therapy in different ways may kill more tumor cells~   "
142168|NCT01706419|"~     Rice fortification has been shown to be safe and effective in improving micronutrient status~     in many studies around the world. However, most studies have been done in Latin America,~     Africa and India. There are no studies available from Cambodia. Moreover, there is no data~     available on whether fortified rice can reduce the prevalence of anemia in school children in~     Cambodia, nor whether there will be additional benefits, such as better learning capability~     of school children or fewer days missed due to better health. To inform WFP, Cambodian policy~     and the public on the potential benefits of fortified rice on health and development for~     Cambodian school children, an intervention study will be conducted in Kampung Speu province~     during the 2012 - 2013 school year. The study will be conducted by IRD, PATH and WFP. Sixteen~     schools will be selected to receive either the normal rice provided by the WFP school meal~     program, or fortified rice instead of normal rice. Three (3) different types of fortified~     rice will be tested, to identify the best type of fortified rice. In addition, 4 schools with~     no school meal program will be selected to serve as control. School attendance and morbidity~     will be followed in all children in the participating schools over the whole school year.~     Biochemical indicators of micronutrient status will be determined in a subgroup of children~     (25% of the children), which requires collection of blood, urine and stool samples.~   "
142169|NCT01706406|"~     The purpose of this study is to pilot test and determine the efficacy of a psychoeducational~     intervention (PED) we recently piloted in a group format for women with acquired sexual~     arousal disorder (FSAD).~      HYPOTHESES:~        1. - Compared to baseline measures, the PED will result in significant improvement in~          self-report measures of: (a) subjective sexual arousal; (b) perception of genital~          arousal/genital sensitivity; (c) orgasmic experience; (d) sexual desire; (e) sexual~          distress; (f) relationship satisfaction; (g) depressive symptoms; and (h) quality of~          life.~        2. - It is unknown what effect the PED will have on actual physiological sexual arousal.~        3. - The group format will be a feasible and cost-effective method of delivering~          empirically supported treatment to women with sexual arousal difficulties and will~          contribute towards meeting the needs for sexual health care for women on the clinic~          wait-list at the BC Centre for Sexual Medicine.~   "
142170|NCT01706393|"~     The purpose of this study is to evaluate the effect of probiotics to improve the intestinal~     microbiome in malignancy patients who get pelvic/abdominal radiotherapy.~   "
142171|NCT01706380|"~     The present study, in an out-patient setting for substance use treatment in adolescents,~     examines the effect on treatment retention of a mobile telephone follow-up technique~     (interactive voice response), with or without personal feedback. Subjects in treatment for~     substance use disorders will be followed by automated mobile telephone contact with questions~     about psychiatric symptoms and substance use, and the investigators hypothesize that this~     technique, including a personal feedback reporting back to the client whether his or her~     status is changing in one way or another, may increase the treatment retention, possibly by~     means of an intensified treatment contact.~   "
142172|NCT01706367|"~     This is a first-in-human study (phase 1) of a 3-dose vaccination regimen with one of three~     dose levels of C difficile vaccine with or without adjuvant in healthy adults aged 50 to 85~     years. The main goal of the study is to determine how safe and well-tolerated the vaccine is.~     In addition, the study aims to assess the immune response to the C difficile vaccine.~   "
142173|NCT01706354|"~     End stage renal failure (ESRF)describes an irreversible loss in renal function. The majority~     of these patients will opt for haemodialysis (HD)as their chosen method of renal replacement~     therapy (RRT). Arteriovenous fistulae (AVF) are the optimal method of achieving vascular~     access to permit HD. AVF are created with a small surgical procdure to join the artery and~     vein together. Over the next 6- 8weeks after surgery the AVF should grow (mature) into a~     vessel suitable for needles to be inserted for dialysis. Unfortunately however, around 24% -~     35% of AVF fail at an early stage. Some anaesthetic techniques can influence intraoperative~     blood flow and venous diameter, factors which are associated with fistula success. There~     remains no conclusive evidence that any particular anaesthetic technique can significantly~     influence long term surgical outcome. This study aims to investigate whether a regional,~     compared to local, anaesthetic technique can affect fistula patency.~   "
142175|NCT01706328|"~     This will be a Phase IIIb multicentre, randomized, double-blind, double-dummy, 12-week~     parallel group study evaluating the effects of once daily in the morning treatment of FF/VI~     Inhalation Powder versus Fluticasone Propionate/Salmeterol Inhalation Powder twice daily on~     lung function in COPD subjects.~      Subjects will be screened and will enter a 2-week, single-blind (placebo), Run-In Period to~     evaluate the subject's adherence with study treatment, study procedures and assessment of~     disease stability.~      At the end of the Run-In Period, subjects will return to the Clinic and who meet all of the~     Randomization Criteria will be randomized to double-blind study medication (12-week treatment~     period). Subjects will be randomized to receive either FF/VI 100/25 via NDPI or Fluticasone~     Propionate/Salmeterol 250/50mcg via ACCUHALER/DISKUS. Matching placebos will be available in~     NDPI and ACCUHALER/DISKUS. Each morning (approximately 6-10 AM) subjects will take 1~     inhalation from the NDPI followed by 1 inhalation from the ACCUHALER/DISKUS. Each evening~     (approximately 6-10 PM), approximately 12 hours after the morning dose with blinded study~     medication, subjects will take 1 inhalation from the ACCUHALER/DISKUS. Subjects will return~     to the clinic at the end of the treatment period.~      A follow-up phone contact will be performed approximately 7 days after the last clinic visit.~     The overall study duration (Screening to Follow-up) for each subject is approximately 15~     weeks.~   "
142176|NCT01706315|"~     This will be a randomized, placebo-controlled, single blind study to investigate the safety,~     tolerability and pharmacokinetic (PK) profile of GSK2140944 following repeat oral doses in~     healthy adult subjects. The study will include a Screening period (40 days), Treatment period~     (16 days) and a Follow-up period (26 to 30 days). A single dose will be administered on Day 1~     for characterization of single dose PK, followed by twice-daily (BID) or thrice-daily (TID)~     dosing on Days 3 to 16. Subjects may only be randomized to one cohort per the randomization~     schedule. Up to 6 cohorts will be enrolled using a sequential panel. Subjects in Cohort 1~     will receive GSK2140944 (6) and placebo (2). Subsequent cohorts will enroll 16 subjects such~     that 12 subjects will receive GSK2140944 and 4 subjects will receive placebo, per dose level~     according to the randomization schedule. Dose escalations are planned to run in successive~     weeks. Cohort 2 may begin dosing once subjects in Cohort 1 have completed 7 days of BID~     dosing, PK data is reviewed and safety data from at least 6 subjects is available. Each~     subsequent dose escalation will commence only when GSK2140944 safety data and available PK~     data of at least 12 subjects dosed at the previous dose level have been reviewed. The number~     of cohorts may be reduced or expanded if needed. The first planned dose is 400 milligram (mg)~     BID but may be modified based upon emergent PK, safety and tolerability data from ongoing~     clinical study BTZ115198 evaluating single and repeat intravenous (IV) doses of GSK2140944.~     The projected dose for Cohort 2 is 800 mg BID, Cohort 3 is 1500 mg BID, Cohort 4 is 2300 mg~     BID or 1500 mg TID and Cohort 5 and cohort 6 will be decided later. The planned maximum dose~     is 2500 mg TID but may be modified based upon emergent safety, tolerability and PK data.~     Doses of GSK2140944 or placebo will be administered following a moderate fat meal.~   "
142177|NCT01706302|"~     The study will assess the burden of RSV-attributable general practice consultations,~     hosptializations, and deaths by age and risk group in in United Kingdom from 1995 to 2009.~   "
142178|NCT01706289|"~     Exploring the relationship between serum VAP-1 and cardiovascular autonomic neuropathy in~     subjects with type 2 diabetes mellitus~   "
142179|NCT01706276|"~     Present study aimed to evaluate the accuracy of Masimo Radical 7 to monitor hemoglobin~     concentrations through compared with laboratory measurement during major hepatic surgery, and~     to determine the source of discordance between two methods.~   "
142180|NCT01706263|"~     One of the main success factors in acne therapy is user compliance with treatment, product~     cost, availability and ease of use. Poor compliance may translate into decreased efficacy~     (either not improving symptoms well enough or not improving symptoms fast enough),~     tolerability issues or adverse effects (eg, erythema, dryness, or peeling of the skin), a~     lack of understanding of the instructions for use, or product cost/availability. Whatever the~     reason, poor compliance translates to decreased efficacy and increased frustration on the~     part of the user.~      The current study will evaluate the efficacy and tolerability of MAXCLARITY II, an over the~     counter, topical benzoyl peroxide (BPO) product line, in subjects with acne.~   "
142181|NCT01706250|"~     One of the main success factors in acne therapy is user compliance with treatment, product~     cost, availability and ease of use. Poor compliance may translate into decreased efficacy~     (either not improving symptoms well enough or not improving symptoms fast enough),~     tolerability issues or adverse effects (eg, erythema, dryness, or peeling of the skin), a~     lack of understanding of the instructions for use, or product cost/availability. Whatever the~     reason, poor compliance translates to decreased efficacy and increased frustration on the~     part of the user.~      The current study will evaluate and compare the efficacy and tolerability of 2~     over-the-counter, topical benzoyl peroxide (BPO) product lines in subjects with acne:~     MAXCLARITY II (2.5% BPO) Foam Cleanser and Foam Treatment and (0.5% Salicylic Acid) Toner~     Foam compared with PROACTIV (2.5% BPO) Renewing Cleanser and Repairing Lotion and~     Revitalizing Toner.~   "
142182|NCT01706237|"~     Evaluate visual outcomes and contrast sensitivity for subjects undergoing bilateral myopic~     LASIK with a Nexisvision Shield or bandage contact lens placed postoperatively. Early speed~     of visual recovery results indicate that the visual recovery in the first 4 hours after the~     LASIK procedure show the most variability. A patient's ability to drive after their LASIK~     procedure would potentially alleviate a challenge that patients often face in taking~     additional time off work or simply finding a ride to there LASIK procedure.~   "
142183|NCT01706224|"~     This study aims to determine the sero-prevalence of anti-pertussis antibodies among~     healthcare professionals at hospital centres in Spain.~   "
142184|NCT01706211|"~     At least 30% of patients initially treated with sulphonylureas for NIDOM will have a poor~     response, and in the remaining 70% the subsequent failure rate is approximately 4% to 5% per~     year. BRL 49653C has a different mechanism of action to the sulphonylureas, and therefore the~     effects on fasting plasma glucose and Hb A1c are expected to be additive. Since circulatory~     insulin levels should decrease, and plasma glucose should be regulated, these combinations~     are also anticipated to slow both the progression of diabetic complications and delay the~     need for exogenous insulin.~      The proposed study is intended primarily to determine the effectiveness of BRL 49653C by~     measure of glucose homeostasis as determined by Hb A1c and fasting plasma glucose, when added~     to sulphonylurea therapy (sulphonylureas are limited to: glibenclamide, glipazide and~     gliclazide). In addition, the clinical safety of BRL 49653C will be assessed in this patient~     population. The starting doses have been selected based on dose response studies examining~     safety, tolerability and efficacy in the U.S.A.~   "
142205|NCT01705938|"~     This is a randomized, phase 1, single-blind, placebo-controlled, randomized, sequential,~     escalating, single-dose, study designed to evaluate the safety, tolerability,~     pharmacodynamics (PD) and pharmacokinetics (PK) properties of orally administered SP-333~     tablets.~   "
142185|NCT01706198|"~     This study is designed to compare the effectiveness and safety of Fluticasone~     Furoate/Vilanterol Inhalation Powder (100mcg Fluticasone Furoate ((FF), GW685698)/25mcg~     Vilanterol ((VI), GW642444) or 200mcg Fluticasone Furoate ((FF), GW685698)/25mcg Vilanterol~     ((VI), GW642444) ) delivered once daily via a Novel Dry Powder Inhaler (NDPI) compared with~     the existing asthma maintenance therapy over twelve months in subjects diagnosed with asthma.~     This is a Phase III multi-centre, randomised open label study. Subjects who meet the~     eligibility criteria are randomised and will enter a 12 month treatment period.~   "
142186|NCT01706185|"~     This study aims to analyze the incidence of expression of MAGE-A3, MAGE-C2, NY-ESO-1, LAGE-1,~     WT1 and PRAME tumor antigens in cancer tissue from patients with pathologically demonstrated~     bladder cancer.~   "
142187|NCT01706172|"~     Dysfunction of the jaw, associated with pain in the jaw or about the jaw in the face can be~     quite long lasting and debilitating. Dextrose injection with a small needle has been notably~     helpful in preliminary studies in reducing pain and improving jaw function. This randomized~     trial will compare dextrose injection with sterile water injection for temporomandibular(jaw)~     dysfunction, also known as TMD.~   "
142188|NCT01706159|"~     This trial is conducted in Europe. The aim of the trial is to investigate the effect of~     recombinant factor XIII (rFXIII) administered to subjects with mild to moderate active~     ulcerative colitis (UC).~   "
142189|NCT01706146|"~     Atrial fibrillation (AF) is the most common sustained abnormal rhythm of the heart, affects~     an estimated 2.5 to 5 million individuals in the US, and can lead to stroke, heart failure,~     and premature death. For those with AF and other stroke risk factors, chronic anticoagulation~     is recommended to prevent intracardiac thrombus formation and stroke even if the AF is~     infrequent or short-lived. This standard of care is based partly on our inability to rapidly~     recognize and respond to AF recurrences which can often be brief and asymptomatic, but~     exposes the patient to the risk of anticoagulant-induced hemorrhage even during prolonged~     periods of sinus rhythm where the risk of stroke is presumably low.~      Recent advances in device technology and drug therapy, however, have the potential to change~     the way the investigators manage AF. The use of a small leadless subcutaneous implantable~     cardiac monitor with remote data transmission capabilities (Reveal XT, Medtronic Inc.)~     provides the ability to remotely and continuously evaluate a patient for AF recurrences, even~     episodes that are brief and asymptomatic. In addition, release of unique oral thrombin~     inhibitor approved for use in non-valvular AF(Dabigatran [Pradaxa], Rivaroxaban [Xarelto])~     allows for rapid onset anticoagulation within minutes to hours of a single oral dose.~     Together, these advances allow for continuous AF monitoring with targeted anticoagulation~     only around the time of an AF episode, thereby reducing the risk of drug-induced hemorrhage~     while still protecting against stroke.~      The aim of this pilot study is to assess the feasibility of intermittent anticoagulation with~     a rapid-onset oral thrombin inhibitor guided by a continuous AF-sensing implantable cardiac~     monitor (Reveal XT) with remote data transmission capabilities.~   "
142190|NCT01706133|"~     -Can a scheme based on inter geriatricians visiting nurse consultants and reduce negative~     impacts on the health of elderly over 70 years ?~   "
142191|NCT01706120|"~     The addition of bevacizumab to first-line chemotherapy has been shown to improve progression~     free survival for patients with ovarian cancer. The purpose of this study is to explore the~     potential role of clinical and biologic factors in identifying those patients who benefit~     most from this combined therapy in terms of progression free and overall survival.~   "
142192|NCT01706107|"~     The primary objective of the study is to evaluate the impact of early treatment with Tysabri~     in Relapsing Remitting Multiple Sclerosis (RRMS) participants on their quality of life (QoL)~     as measured by Multiple Sclerosis Impact Scale-29 (MSIS-29) over 2 years. The secondary~     objectives of the study are: to evaluate the impact of early treatment with Tysabri in RRMS~     participants over 2 years on the following: annualized relapse rate (ARR), Expanded~     Disability Status Scale (EDSS), work productivity, quality of life (QoL) by EuroQol~     5-Dimension questionnaire (EQ-5D), QoL by Subject Global Assessment of Wellbeing visual~     analog scale (VAS) and to evaluate clinical disease-free status (relapses, EDSS) over 2~     years.~   "
142193|NCT01706094|"~     A simplest manner to augment cerebral blood flow to irrigate the ischemic penumbra in acute~     ischemic stroke could be to place the patient in a 'lying flat' rather than upright head~     position. Given uncertainty over the balance of potential modest benefits and risks, and~     variability regarding the ideal head position policy for patients with acute ischemic stroke~     around the world, reliable randomized evidence is required to standardize clinical practice.~      The main objectives of this pilot phase clinical trial are to determine the feasibility,~     safety and potential efficacy of a large-scale cluster randomized clinical trial to assess~     whether a simple nursing care policy - 'lying flat head position' - provides beneficial~     effects as compared to the standard upright head position in patients with acute ischemic~     stroke. The main efficacy outcome of the pilot phase is demonstration of increased mean~     cerebral blood flow velocity in the flat down compared to the upright head position, as~     assessed by transcranial Doppler to the medial cerebral arteries of patients with anterior~     circulation infarction. Secondary efficacy objectives are to demonstrate that the flat down~     head position improves neurological status at 7 days and disability at 90 days.~   "
142194|NCT01706081|"~     This study is being done because women have arm swelling for more than 6 months despite~     wrapping and other treatments. This swelling is called lymphedema. It is the back up of lymph~     system fluid that causes swelling in the arm. The swelling can just happen, but more commonly~     it is caused when lymph nodes are removed during cancer surgery. It can develop right after~     breast cancer treatment or weeks, months or even years later. In our preliminary research,~     the investigators found that more than 1/3 of the 33 patients showed at least a 30% reduction~     in lymphedema following acupuncture treatment and there were no serious adverse events during~     the treatment or 6 month followup.~      This study will include a larger group of patients. Patients will be assigned to one of two~     groups, and results of the groups will be compared to see if acupuncture can reduce~     lymphedema and whether the effect lasts after acupuncture treatment is completed.~   "
142206|NCT01705925|"~     The purpose of the study is to provide comprehensive follow-up in patients with Long QT~     Syndrome (LQTS) and gain additional information regarding genotype-phenotype correlation and~     effective management and treatment options.~   "
142195|NCT01706068|"~     Background:~      The importance of ischemic ECG changes including St segment elevation, ST segment depression~     or T wave inversion that indicate myocardial ischemia are well established and require~     appropriate investigation and treatment.~      However, there is an abundance of clinical situation, with apparently ischemic ECG change not~     indicate traditionally coronary artery related ischemia and therefore require prompt~     recognition and treatment of underlying condition, that may be serious and life-threatened.~     For example of such conditions are pericarditis, myocarditis, aortic dissection, electrolyte~     abnormalities, intracranial hemorrhage and hypothermia.~      Together with them, an ECG ST segment changes may appeared in abdominal serious illness such~     as pancreatitis and cholecystitis(17,18,19,20,23). Whereas in pancreatitis various vasoactive~     and toxic for myocardium substances released, the cause of ST segment changes in~     cholecystitis are discussed and includes tachycardia , vagal reflexes, changed in plasma~     rennin activity resulted by distension of the gallbladder.~      The certain proportion of the patients with ECG changes actually didn't have coronary artery~     disease(9,15) or other acute cardiac condition and therefore require treatment of the~     underlie illness only without spend the time for cardiac investigation or special~     treatment(1,3,4,7,8). Some kind of treatment may be even harmful for the patients with~     abdominal illness such as thrombolytic, anticoagulant, aggressive antiaggregant therapy or~     unnecessary cardiac catheterization.~      In the medical literature the investigators found some case reports and works about the ECG~     changes in acute biliary disease in patient with knowing cardiac disease and without it, but~     actually incidence of ECG changes that suggest but not represent an acute coronary illness~     isn't knowing.~      Therefore this is necessary to investigate actually incidence of ECG changes that mimic acute~     coronary syndrome in acute cholecystitis and acute biliary disease and determined clinical~     and laboratory characteristics that helps to differentiate this patients.~   "
142196|NCT01706055|"~     This will be prospective, multicentre, observational study. Patients who will initiate~     treatment with IFNβ-1b (Betaferon) will be followed up to 6 months. Baseline visit (visit 0)~     i.e. treatment initiation plus four follow-up visits (visits 1-4). For each patient~     demographics, medical history data, safety parameters, presence of flu-like symptoms and~     measures to prevent or treat these symptoms will be collected.~   "
142197|NCT01706042|"~     Dietary prevention strategies are increasingly recognized as essential to combat the current~     epidemic of obesity and related metabolic disorders. The purpose of the present study was to~     evaluate the potential effects of legumes in relation to cardiometabolic risk markers and~     appetite regulating hormones.~   "
142198|NCT01706029|"~     Rheumatoid Arthritis (RA) is an inflammatory chronic rheumatism where the pain remains the~     priority domain of improvement for the patients instead a good control of the inflammatory~     disease by treatments, even biotherapeutics .~      Some studies show that less than 50 % of the patients is satisfied by the care of the pain,~     whereas the criteria of evaluation of the RA improve under treatment. The chronic pain, is a~     complex and multifactorial subjective phenomenon requiring a multidimensional evaluation,~     while the current criteria of follow-up of the RA (DAS28, ACR criteria) investigate the pain~     in a single dimension that is the pain intensity.~      So, the investigators do not arrange explanation for this observed dichotomy between the~     improvement of the clinical and biological inflammatory criteria of the RA and on the other~     hand the persistence of pain.~      On the other hand, the interleukin (IL)-6, IL-17 and IL-33 are cytokines occurring in the~     physiopathology of RA and probably in the pain processing according to recent data of the~     literature.~      The aim of this study is:~        -  to assess the multidimensional origin of the pain in RA patients by means of~          questionnaires~        -  to look for a possible correlation between the serum level of cytokines and pain.~   "
142199|NCT01706016|"~     Demonstrate the effectiveness of laser in the treatment of cancerous lesions by determinating~     with histological analysis of the specimen the percentage of tumor cells remaining in the~     area treated by the laser~   "
142200|NCT01706003|"~     Patients will be randomly assigned to receive their follow-up care via telemedicine or~     in-office visits.~   "
142201|NCT01705990|"~     The purpose of this study is to evaluate the safety, tolerability and immunogenicity of~     Sendai HIV vaccine SeV-G(NP) given intranasally and Ad35-GRIN administered intramuscularly in~     prime-boost regimens in HIV-uninfected, healthy adult volunteers.~   "
142202|NCT01705977|"~     The purpose of this study is to further enhance the existing knowledge regarding the side~     effects of belimumab when given with other lupus medicines to adults with active systemic~     lupus erythematosus (SLE). This study mainly focuses on collecting information on serious~     events that are not that common or may only be seen with long-term treatment. These events~     include death, serious infections and other infections of interest, cancers, serious mental~     health problems, including depression and suicide, and serious infusion and hypersensitivity~     reactions. This study is being done to help understand if treatment with belimumab increases~     the risk for these types of events. This study will also see if patients receiving belimumab~     with other lupus medicines can reduce their use of steroids, such as prednisone, over 1 year.~   "
142203|NCT01705964|"~     Project Aim: To determine if intramuscular epinephrine is an effective adjunct to inhaled~     bronchodilators (β2 agonists) for children with severe asthma exacerbation.~      Hypothesis: IM epinephrine is an efficacious adjunct to inhaled bronchodilators (β2 agonists)~     for children with severe asthma exacerbation.~      Intervention: Subjects will be randomly assigned (50% chance) to receive a weight based dose~     of IM epinephrine 1:1000 or no adjunctive medication. The dose will be 0.2 mg for subjects~     20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by~     an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23~     gauge one inch needle.~      In addition to the study intervention, the standardized treatment pathway based on the~     current asthma guidelines in use at the investigator's center will be utilized. This pathway~     includes nebulized albuterol, ipratropium bromide, and systemic corticosteroids. The duration~     and dosages of these other interventions will be administered at the discretion of the~     treating provider.~   "
142204|NCT01705951|"~     This project is prompted by the urgent public health need to identify novel strategies to~     prevent and treat tobacco-related cardiovascular disease (CVD) and by compelling pilot data~     that suggests cessation of smoking results in rapid amelioration of endothelial function. The~     higher prevalence of CVD and metabolic syndrome in smokers have become major health care~     concerns. Therefore, finding optimal intervention strategies to combat these growing~     epidemics is imperative. We are investigating the efficacy of resistance training to~     ameliorate endothelial dysfunction, oxidative stress, inflammation, and insulin resistance in~     four groups: presence or absence of resistance training with or without cessation treatment +~     nicotine replacement.~      The investigators hypothesize that resistance training will improve cardiovascular function~     in smokers; however, the responses will be better in those who also stop smoking. In~     addition, resistance training will decrease smoking, however, the effects of counseling and~     nicotine replacement alone or counseling and nicotine replacement in conjunction with~     resistance training will be better than resistance training alone.~   "
142207|NCT01705912|"~     The purpose of this study is to assess effects of a home exercise program, supervised by~     assistant nurses with the aim of preventing falls.~      Community living persons 65 years of age or older having a risk of falling were invited to~     participate. Participants were randomized to either training or control.~      The training program was individually designed by a physiotherapist and the 5-month program~     performance was supervised in the partcipants home by eight home visits from an assistant~     nurse.~      All participants received a visit from an occupational therapist who assessed the home and,~     if necessary, gave advice.~   "
142208|NCT01705899|"~     Islet transplantation can provide physiologic insulin replacement to patients with type 1~     diabetes without the complications associated with whole pancreas transplantation. The~     purpose of this study is to achieve insulin-independence in patients with type 1 diabetes,~     thereby eliminating the need for exogenous insulin injections to maintain normal glucose~     levels, ameliorating severe hypoglycemia and potentially decreasing the development of~     diabetes-related complications. This study will investigate islet transplantation in subjects~     who have preserved renal function and subjects who have undergone cadaveric renal~     transplantation, since the latter subjects are already on immunosuppression.~      This is a single center, prospective trial of islet transplantation in subjects receiving~     islets alone or islets after kidney transplant. This is a phase I study investigating the use~     of islet transplantation for the treatment of type 1 diabetes. Subjects will be eligible for~     an islet transplant if they meet all of the inclusion criteria and none of the exclusion~     criteria outlined in the protocol. In brief, the aims of this study are to establish an islet~     transplant program at the Ohio State University, determine the safety of islet~     transplantation in islet alone and kidney transplant recipients, determine whether islet~     transplantation will reduce the frequency of severe hypoglycemic events, determine whether a~     novel steroid-free immunosuppressive protocol will prevent rejection in islet transplants and~     to achieve insulin independence at one year after the final islet transplant.~   "
142209|NCT01705886|"~     The purpose of this study is to document and compare the surgical and after surgery costs,~     recovery time, and outcomes of two procedure types:~        -  Robotic assisted surgery replacing one compartment of the knee~        -  Manual (robot is not used) surgery replacing all three compartments of the knee (total~          knee replacement)~      The hypothesis is that robot assisted partial knee replacement is cost effective and provides~     clinical outcomes that are equivalent to a manual total knee replacement.~   "
142210|NCT01705873|"~     The objective of this study is to evaluate changes in Framingham score (from low to moderate,~     from moderate to high) based on changes in lipid profile and other parameters from baseline~     to 48 weeks of HAART in naïve patients or patients in second line of treatment, considering~     LPV/r vs EFV based HAART. The null hyphotesis is that there is an increased Framingham score~     in patients treated with LPV/r as second line treatment and in patients treated with LPV/r or~     EFV regimen as first line treatments.~   "
142211|NCT01705860|"~     The present study will evaluate the long term effects on scar formation for dermatome-induced~     skin wounds treated with Collagenase Santyl® Ointment or vehicle (white petrolatum ointment)~     alone. The previous study, 017-101-09-001, utilized a small, experimental, cutaneous wound to~     evaluate both time to complete wound closure and quality of the resulting scar when~     Collagenase Santyl® Ointment was used to treat the wound.~   "
142212|NCT01705847|"~     This study is to determine the appropriate dosing regimen of GS-9820 in subjects with~     lymphoid malignancies. This is a Phase 1b, open-label, dose-escalation and expansion study~     evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of GS-9820.~   "
142213|NCT01705834|"~     This study will investigate if an electronic dataglove can be used to measure joint stiffness~     in patients with Rheumatoid Arthritis.~   "
142214|NCT01705821|"~     This study is designed to measure forces applied using standard surgical instruments at the~     skull base during resection of skull base lesions. This data will be useful for optimizing an~     active canula robot for assisting in skull base surgery. We hypothesize that through~     measurement of forces generated during routine endoscopic skull base surgery we will be able~     to optimize the canulas of an active canula robot for skull base surgery.~   "
142215|NCT01705808|"~     Severe sepsis and septic shock are life threatening medical emergencies and are among the~     most significant challenges in critical care. Case reports and case series suggest that~     plasma-derived protein C concentrate may improve the outcome of patients with acquired~     protein C deficiency. Evidence has accumulated on the clinical relevance of the PC pathway in~     modulating overwhelming inflammation and preventing coagulation derangements, two key~     mediators of organ damage, and thus of mortality and morbidity, in sepsis. The experience~     collected through these studies shows that PC is safe, in that it is not associated with~     bleeding or severe allergic complications,and possibly useful, at least to improve the~     coagulation abnormalities brought about by sepsis. Unfortunately, however, all we know comes~     from case series or case reports or an underpowered randomized controlled study. A randomized~     clinical trial, adequately powered for mortality or clinically relevant outcome, is necessary~     to confirm PC efficacy.The aim of this study is to demonstrate that Protein C zymogen has~     clinically relevant implications in terms of reduction of thromboembolic events, 30 days~     mortality, length of intensive care and hospital stay, time on mechanical ventilation, length~     of ICU and hospital stay. The study will also confirm that there is no bleeding concern with~     the use of Protein C concentrates.The study drug will be administered in the Intensive Care~     Unit for 72 hours and the patients observed till ICU discharge. Telephone followup will be~     performed at 30 days and at one year.~   "
142216|NCT01705795|"~     Randomized, placebo-controlled, double-blind study evaluating the effect of anti-IL-5-therapy~     in patients with bullous pemphigoid. The primary study objective is to determine the efficacy~     of an anti-IL-5 monoclonal antibody therapy, administered as 750mg mepolizumab, in patients~     with bullous pemphigoid.~   "
142252|NCT01705327|"~     This is an observational, multi-center study to assess clinical features and biologic~     biomarkers in Parkinson's disease (PD) patients compared to healthy controls (HC). The~     primary objective of this study is to discover clinical and biologic markers of PD for use in~     clinical trials of disease-modifying therapies.~   "
142360|NCT01703910|"~     The purpose of this study is to assess the feasibility of selecting personalized therapies~     for colon cancer patients who have failed standard treatments, using a new methodology based~     on the determination of a profile of chemosensitivity by comprehensive genetic expression~     analysis from tumor samples.~   "
142217|NCT01705782|"~     The purpose of the study is to investigate the metabolic effects during acute inflammation~     with and without the nutritional supplement of amino acids.~      E. Coli Endotoxin (LPS, lipopolysaccharide) is used to initiate an inflammatory response.~      The study is an interventional randomized placebo study including 8 healthy male subjects.~     Each subject participates 3 times (different days) and are given one of following~     interventions:~        -  Placebo (NaCl)~        -  Endotoxin, US standard reference E.Coli + Placebo (NaCl)~        -  Endotoxin, US standard reference E.Coli + Amino acids (intravenously)~      It is our hypothesis that the nutritional intervention during acute inflammation plays an~     important role in lipid and protein metabolism.~   "
142218|NCT01705769|"~     This project aims to assess the efficacy of three options under consideration in India for~     home management of Severe Acute Malnutrition (SAM). The investigators propose to conduct a~     multi-center randomized controlled trial to determine the efficacy of two community-supported~     home-based regimes using centrally or locally produced Ready to Use Therapeutic Foods (RUTF)~     for recovery from uncomplicated SAM after 16 weeks of management, compared with an augmented~     home-prepared foods regimen. The trial will enroll 911 children with uncomplicated SAM and~     will have enough statistical power to detect a 15% or greater difference in recovery rates~     between either one of the intervention groups compared with comparison group.~   "
142219|NCT01705756|"~     FMF is the most common periodic fever with a worldwide patient population estimated as~     150,000, mainly located in the Eastern Mediterranean basin. colchicine is the established~     therapy of choice ,however, around 20.000 patients worldwide fail to respond or cannot~     tolerate therapeutic doses, thereby suffering from recurrent debilitating, severe, painful~     attacks of peritonitis, pleuritis and synovitis and are at risk to die from reactive~     amyloidosis .Mutation-induced reduction in pyrin/ marenostrin activity is thought to underlie~     the disease by leading to NALP3 inflammasome activation ,and thereby to IL-1β related burst~     of inflammation.~      The IL-1 receptor antagonist Kineret (Anakinra), seems to be the most appropriate response to~     the uncontrolled IL-1β elevation. Indeed, an increasing number of reports over the last few~     years indicate a good response to Kineret (Anakinra), in colchicine-resistant FMF ,also in~     children ,however, no controlled study has thoroughly evaluated the efficacy and safety of~     this treatment.~      Study outline:~      The study aims to run at the FMF centre in Sheba Medical Center, covering more than 10,000~     patients. The study will evaluate the effect of recombinant IL-1 receptor antagonist, Kineret~     (Anakinra), on the frequency of FMF attacks in patients that, despite maximum tolerable dose~     of colchicine, present with more than one attack per month.~      The study is designed as a randomised, placebo-controlled, double-blind study. 50 patients~     will be randomised to treatment with either Kineret (Anakinra), or placebo treatment for 4~     months.~   "
142220|NCT01705743|"~     In order to investigate the effect of a combination effect of sevoflurane and nitrous oxide~     on cerebral electrical activity, the investigators determined the MAC of sevoflurane combined~     with nitrous oxide inducing isoelectric electroencephalogram (EEG) in 50% of the subjects~     (MACie) in middle aged subjects.~   "
142221|NCT01705730|"~     This observational study will evaluate the use and efficacy of RoActemra/Actemra~     (tocilizumab) in monotherapy in routine clinical practice in patients with rheumatoid~     arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the~     licensed label will be followed for 6 months.~   "
142222|NCT01705717|"~     This retrospective, observational study will assess the real world treatment out comes in the~     management of patients with chronic hepatitis C. No prospective ass essment or procedure with~     patients during this study will be conducted. Data wil l be collected from patient medical~     records of the year 2000-2011.~   "
142223|NCT01705704|"~     This retrospective study will evaluate the association of biomarkers and the treatment~     response of patients with chronic hepatitis B, who have completed therapy with Pegasys~     (peginterferon alfa-2a) ± lamivudine. For the analysis stored serum samples obtained from~     patients will be used; no actual patients are involved.~   "
142224|NCT01705691|"~     NSABP FB-9 is a Phase II, multi-center, randomized study of eribulin or weekly paclitaxel~     followed by doxorubicin and cyclophosphamide (AC) as neoadjuvant therapy for women with~     HER2-negative, operable and locally advanced breast cancer (stage IIb and III). Patients in~     the control arm will receive neoadjuvant weekly paclitaxel (WP) followed by AC. The primary~     aim of the study is to determine the pathologic complete response (ypCR) in breast and~     axillary lymph nodes following completion of neoadjuvant therapy. The secondary aims include~     determination of the ypCR in axillary nodes, clinical complete response (ycCR) rate after~     eribulin or paclitaxel and after completion of neoadjuvant chemotherapy, two-year~     recurrence-free interval, two-year overall survival, and toxicity of the neoadjuvant~     regimens.~   "
142225|NCT01705678|"~     There is some evidence that dietary supplementation with fish oil has health benefits,~     especially in respect of some of the known risk factors for cardiovascular (heart) disease~     such as cardiac arrhythmia. However, supplies of fish oil are limited, and it is desirable to~     validate alternative sustainable sources of the important omega−3 fatty acid components. It~     has been suggested that oil from krill, which are small marine crustaceans, may be as~     effective or possibly more beneficial than fish oil, and may provide a more effective and~     beneficial supplement. Dietary management of cardiovascular health parameters (such as blood~     lipids)is becoming more and more important as the rising trends in obesity nationally and~     worldwide are leading to escalating incidence of diabetes and heart disease. The~     investigators propose to use some specific novel lipid measurements of cardiovascular risk to~     test this possibility in a group of men who, although generally healthy, show some risk~     factors in terms of their weight and metabolic profile.This pilot study will provide~     preliminary data to show whether krill oil has similar or different effects from fish oil on~     the cardiovascular health of overweight but otherwise healthy men, and in particular will~     provide detailed information on alterations in novel lipid markers of cardiovascular disease,~     which may be a better diagnostic tool than classical lipid measurements (e.g. serum~     cholesterol). The investigators have been developing and validating new techniques to measure~     emerging lipid markers of cardiovascular risk accurately and will continue to develop and~     investigate these techniques during the course of this project. The investigators hypothesise~     that krill oil will be more efficacious in reducing markers of risk relating to~     cardiovascular disease.~   "
142361|NCT01703897|"~     The purpose of this study is to evaluate the effects of anesthesia on the esophageal body in~     obese patients before and during anesthesia.~   "
142226|NCT01705665|"~     This study was initiated on the preliminary premise that a thrombus whose formation was~     triggered by a thrombogenic substrate, such as within an atherosclerotic plaque (Tissue~     factor initiated thrombus), may evolve differently than the one evolving at the site of a~     recently implanted stent (foreign body triggered). Consequently, the thrombus composition of~     a de novo clot could differ from the other one, extracted during the occurrence of a subacute~     thrombosis, regarding the number of various cells, the amount of fibrin and platelet~     aggregates and the relationship among these components. In addition, it seems relevant to~     evaluate the numbers and the distribution of the local monocytes, once these cells may~     interact with platelets (via cell -adhesion mechanisms e.g., by CD31 [PECAM-1]) and by the~     extrinsic coagulation pathway (via TF/FVII elaborated by plaque-resident macrophages). Such a~     distinction, if eventually found, may reveal the mechanisms of thrombosis within coronary~     arteries, and may have clinical implications.~   "
142227|NCT01705652|"~     The purpose of the study is to (1) to determine the rate of PSA decline (the number~     declining). Tissue will be obtained for ancillary studies and (2) to determine the number of~     patients with a PSA decline to <1.0 ng/ml at 3 months in patients receiving Nexrutine® with~     standard radiation therapy. The Secondary Objective is to confirm the tolerability of this~     regimen. The Third Objective (Ancillary studies) is To evaluate the molecular response of~     Nexrutine®. Molecular response is defined as changes in the molecular pathways.~   "
142228|NCT01705639|"~     The effect of 3 months of melatonin 4mg treatment on glucose tolerance in different variants~     of the melatonin receptor 1B gene will be evaluated. The following will be done at 0 and 3~     months:~        -  OGTT~        -  questionnaires about sleep and activity~        -  Actigraph~        -  Anthropometry~        -  Blood pressure~   "
142229|NCT01705626|"~     The purpose of this study is to determine the prevalence of patients with a polyneuropathy of~     undetermined etiology based on the normal results of laboratory data (CRP, glucose,~     electrolytes, urea,transaminases, TSH, immunoglobulins, vitamin B12, RF, ANA, antibodies~     against Lyme borrelia) no anamnesis for carcinoma, no continuous alcohol consumption; no~     light-chain-amyloidosis; no anamnesis for heavy metal exposure.~   "
142230|NCT01705613|"~     The first objective is to measure the QALYs (Quality Adjusted Life Years) of Brazilian~     children and adolescents, submitted to methylphenidate immediate-release treatment for~     Attention Deficit Hyperactivity Disorder (ADHD). For this, the Health Utility Index scale~     (HUI) will be completed by the patient and/or family, in two moments of an observation study~     with immediate-release methylphenidate: at the baseline and 6th month of treatment in the~     follow-up. The results provides information to calculate the utility measure and determine~     the QALYs (Quality Adjusted Life Years). After this, for the cost-effectiveness of the~     treatment, it will be used a Markov model of decision analysis, and a Monte Carlo simulation~     with 10,000 random trials.~      Subjects will be submitted to immediate-release methylphenidate treatment in a maximum dose~     of 0.5mg/kg/day. The total treatment monitoring is 06 (six) months, and patients will be~     evaluated at baseline, first, third and sixth month. The HUI rating scales are fulfilled by~     parents and patients (if >12 years old only) at baseline and 6th month. The period for~     inclusion of new patients comprises from 01/01/2011 to 31/12/2013.~   "
142231|NCT01705600|"~     The primary goal of this study is to examine the effects of limiting complaints on pain and~     pain catastrophizing (PC) in individuals with low back pain (LBP) who are in a state of~     central sensitization (CS).~      The study will be performed on individuals who have LBP and are in a state of CS. CS is~     classified as a type of pain which has the following dominant features: pain that is~     disproportionate to the nature or extent of injury/pathology; disproportionate,~     non-mechanical, unpredictable pattern of pain provocation in response to aggravating/easing~     factors; strong association with maladaptive psychological factors~      ; diffuse/non-anatomic areas of pain/tenderness to palpation. These criterion have been~     demonstrated to have discriminative validity for diagnosing CS.~   "
142232|NCT01705587|"~     This open label comparison study examines the hypothesis that teriparatide given immediately~     following repair of an atypical subtrochanteric or diaphyseal femoral shaft fracture will~     enhance healing and improve bone mineral density compared to delayed treatment (after six~     months) with teriparatide or no treatment with teriparatide (patients who refuse therapy or~     for whom teriparatide is contraindicated). Patients with up-front teriparatide in addition~     will have greater quality of life measures and less pain compared to those with delayed or no~     therapy.~   "
142233|NCT01705574|"~     This study will evaluate the safety, efficacy, and tolerability of a regimen containing~     elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF)~     fixed-dose combination (FDC) versus ritonavir (RTV)-boosted atazanavir (ATV) plus~     emtricitabine/tenofovir disoproxil fumarate (Truvada®; FTC/TDF) in HIV-1 infected,~     antiretroviral treatment-naive adult women.~      This study will consist of two phases: Double-Blinded Treatment Phase (48 weeks) and~     Open-Label Extension (OLE) Phase (48 weeks).~      After 48 weeks of blinded treatment, participants will continue to take blinded study drug~     for 12 weeks and return for an Unblinding Visit at Week 60. Participants who are~     virologically suppressed at Week 48 during the Double-Blinded Treatment Phase will have the~     option to enter the OLE Phase.~   "
142234|NCT01705561|"~     -  Assess the attitudes and feelings of premenopausal Latin American women towards the risk~          of loss their fertility by adjuvant chemotherapy.~        -  Correlate the attitudes with other variables including age at diagnosis, already having~          children, number of children, level of instruction, marital status, frequency of~          menstrual cycle.~   "
142235|NCT01705548|"~     This phase I trial studies the side effects and best dose of hypofractionated radiosurgery in~     treating patients with large brain metastasis. Stereotactic radiosurgery can send x-rays~     directly to the tumor and cause less damage to normal tissue. Giving fractionated~     stereotactic radiosurgery may kill more tumor cells.~   "
142253|NCT01705314|"~     The goal of this study is to assess the effectiveness of vitamin D in reducing~     laboratory-confirmed influenza and in reducing non-influenza viral respiratory tract~     infections. A cohort of children between the ages of 3 and 17 years from the Thanh Ha~     Commune, Thanh Liem District, Ha Nam Province, Vietnam will be randomized to either weekly~     vitamin D supplements or placebo. Participants who develop acute respiratory infection over a~     12-month period, will be tested for influenza, the co-primary outcome, and other respiratory~     viruses, the other co-primary outcome, by RT-PCR.~   "
142236|NCT01705535|"~     Fecal incontinence is the complaint of involuntary loss of feces. Fecal incontinence affects~     2-12% of the adult population. It is a hidden problem - less than one third of the affected~     persons discuss the problem with their doctor. The condition has a negative effect on quality~     of life. It is associated with shame and limitation in social life, leisure, occupational and~     sexual activities.~      Pelvic floor muscle exercises with or without the use of biofeedback has been recommended and~     used for the treatment of fecal incontinence over the last decades. Several uncontrolled~     trials and some controlled trials have shown a positive effect of this training, but most of~     the trials are small and/or have methodological problems. Therefore there is to day still a~     lack of sufficient evidence for the effect of pelvic floor muscle exercise as a treatment of~     fecal incontinence.~      The aim of this study is to compare the effect of an individual physiotherapeutic supervised~     pelvic floor muscle training program with a control physiotherapeutic treatment (massage of~     the neck and back). Both treatments will be given parallel with standard information and~     guidance given by a nurse specialized in anal incontinence issues.~      Study hypothesis: Pelvic floor muscle exercises given parallel with standard advice and~     guidance by a specialized nurse, provides better effect to reducing fecal incontinence than~     control treatment and standard advice alone.~   "
142237|NCT01705522|"~     The investigators intend to assess the role of several biomarkers in the prediction of~     relapse in IBD. Clinical, laboratory and endoscopic data will be gathered and a predictive~     score will be derived in order to assess the relapse risk at 1 year.~   "
142238|NCT01705509|"~     This is a proof of concept trial using ranolazine, a medication, in patients with known~     Coronary Artery Disease and reduced left ventricular function, EF < 40%. We propose that~     ranolazine therapy will result in demonstrative improvements in cardiac function that can be~     objectively assessed using the parameters measured with CPET. We propose that demonstrative~     improvement in CPET parameters on ranolazine will translate into improved patient outcomes~     for this patient population.~   "
142239|NCT01705496|"~     This protocol will evaluate the sensitivity and specificity of [124I]FIAU as a diagnostic~     imaging agent for the detection of prosthetic joint infections in patients.~   "
142240|NCT01705483|"~     The purpose of this study is to determine the safety and tolerability and pharmacokinetics of~     ASP9853 combined with docetaxel or with paclitaxel in subjects with advanced non-hematologic~     malignancies.~   "
142241|NCT01705470|"~     The study Objective is to assess the clinical and echocardiographic changes of patients with~     systolic dysfunction receiving blood transfusion, with or without prior treatment with~     furosemide~   "
142242|NCT01705457|"~     The aim of this study is the comparison between the effects of supplementation with 25000 IU~     preformed vitamin A (retinyl palmitate)on retinoic acid receptor and retinoic x receptor~     expression.~   "
142243|NCT01705444|"~     Acute urinary retention is considered one of the most common problems in the older age,~     especially those who have benign prostatic hyperplasia. Solving the problem of acute urinary~     retention using the Foley catheter still causes problems at the level of patient movement and~     the daily exercises. However, with the emergence of a new device, the spanner, investigators~     believe that many of the above mentioned problems can be resolved. This tool may provide more~     freedom for the patient.~   "
142244|NCT01705431|"~     The purpose of the On Track intervention is to address a need raised by a day-treatment~     school in Lane County: Support for students transitioning from the day-treatment school (Lane~     School) to their district middle schools. Eligible students are currently attending Lane~     School, in middle school (Grades 6-8), with or at risk for Emotional Disturbance, and are~     preparing to transition to their district schools.~   "
142245|NCT01705418|"~     Improvement of behavioral addictions in STN-DBS in PD: Long term follow-up~   "
142246|NCT01705405|"~     Visualize surgical needles inserted in the prostate, under the ultrasound modality.~   "
142247|NCT01705392|"~     The purpose of this study is to compare efficacy of bevacizumab monotherapy with standard~     chemotherapy (DTIC) in patients with metastatic malignant melanoma. In addition, we want to~     evaluate the predictive value of a set biomarkers associated with vascular endothelial growth~     factor (VEGF) dependent angiogenesis. Also, we aim to identify mechanisms causing acquired~     resistance to treatment with bevacizumab and escape mechanisms caused by other angiogenic~     growth factors than VEGF. Finally, we want to analyze safety and influence on outcome~     variables by primary prevention of bevacizumab induced hypertension by low dose beta blockers~     in comparison with an ACE inhibitor.~   "
142248|NCT01705379|"~     A multicenter, single arm, postmarketing surveillance study. This study is a postlicensure~     requirement of the Philippine Food and Drug Administration (FDA) to provide continued safety~     evaluation of MenACWY-CRM in Philippine individuals 2 years of age and older, receiving~     MenACWY-CRM vaccination according to routine clinical practice and prescribing information.~   "
142249|NCT01705366|"~     The objective of this study is to document the demographic and clinical characteristics and~     the long-term clinical outcomes of patients who require a robot assisted knee arthroplasty.~      The hypothesis is that MAKO® robot assisted surgery replacing one or two compartments of the~     knee joint has 10 year implant survival and clinical outcomes that are equivalent to other~     knee replacement systems.~   "
142250|NCT01705353|"~     The purpose of this study is to measure the presence of HMGB-1 and other proteins in the~     blood across five time points after stroke, and to determine if their presence correlates~     with rate of stroke recovery.~   "
142251|NCT01705340|"~     This phase I trial studies the side effects and best dose of Akt inhibitor MK2206 and~     lapatinib ditosylate when given together with trastuzumab in treating patients with locally~     advanced or metastatic human epidermal growth factor receptor-2 (HER2)-positive breast,~     gastric, or gastroesophageal cancer that cannot be removed by surgery. Akt inhibitor MK2206~     and lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes~     needed for tumor growth. Monoclonal antibodies, such as trastuzumab, can block tumor growth~     in different ways. Some block the ability of tumor cells to grow and spread. Others find~     tumor cells and help kill them or carry tumor-killing substances to them. Giving Akt~     inhibitor MK2206 and lapatinib ditosylate together with trastuzumab may kill more tumor~     cells.~   "
142254|NCT01705301|"~     In this study, the investigators will monitor extracellular neurotransmitter levels using a~     probe that is able to perform real time electrochemical detection during deep brain~     stimulation surgery. The overall question this study is designed to answer is: Are there~     neurotransmitters released during deep brain stimulation?~   "
142255|NCT01705288|"~     Over 600,000 hysterectomies are performed annually in the United States. Despite increasing~     use of less invasive approaches, the majority of hysterectomies are still performed via~     traditional laparotomy, which can be associated with generally slower recovery and longer~     lengths of post-operative hospitalization. Rapid Recovery Protocols (RRP) seek to optimize~     post-surgical morbidity outcomes by returning a patient to normal physiology as quickly as~     possible following surgery.~   "
142256|NCT01705275|"~     A study to investigate the efficacy of ONO-8539 on acid-induced oesophageal hypersensitivity~     in healthy male adult volunteers.~   "
142257|NCT01705262|"~     The purpose of this study is to determine whether Moviprep or Phosphoral is the best method~     of bowel preparation before colonoscopy - seen by the patients and by the endoscopist.~   "
142258|NCT01705249|"~     This study is conducted in Europe. The aim of this study is to investigate the bleeding~     profile after switch from Trisekvens® to Activelle® (1.0 mg estradiol / 0.5 mg norethisterone~     acetate (NETA)).~   "
142259|NCT01705236|"~     This is a 3-year, prospective, multi-center, open-label study to describe the long term~     changes of optical coherence tomography (OCT) parameters in RRMS patients under treatment~     with Fingolimod. It is designed to longitudinally study the degeneration of retinal axons by~     measuring change in RNFL thickness by latest OCT-technology. Correlations of OCT findings~     with available MRI data and clinical findings may enhance our understanding of the~     relationship between CNS inflammation, tissue injury, regeneration and neurological deficit~     in the context of fingolimod therapy.~   "
142260|NCT01705223|"~     This trial studies the safety and immunogenicity of a HIV clade B'/C DNA vaccine followed by~     recombinant vaccinia virus rTV boost in HIV-uninfected healthy volunteers at low or high risk~     of HIV infection. In addition, the effect of different intervals of the prime-boost will be~     studied.~   "
142261|NCT01705210|"~     The exact neuronal mechanism underlying the cognitive decline associated with diabetes~     mellitus type 2 (DM2) still remains to be elucidated. Multi-parametric functional MRI can~     potentially provide functional, micro-structural, micro-vascular, and metabolic information~     on the affected brain at an earlier stage than does conventional structural MRI. The overall~     aim of the current proposal is to obtain a better understanding in the neuronal mechanisms~     that underlie cognitive decline in DM2 and the putative prediabetic condition the metabolic~     syndrome (MetS).~   "
142262|NCT01705197|"~     The objective of this study is to evaluate the safety and efficacy of Avanafil in the~     treatment of erectile dysfunction with moderate to severe in subjects. And, this is to~     additionally confirm the efficacy and safety after initiating treatment with Avanafil 100mg~     and later increasing to 200mg, compared with continuing treatment with Avanafile 100mg, in~     subjects.~   "
142263|NCT01705184|"~     At present, the treatment of non-squamous cell lung cancer is based on chemotherapy with~     platinum eventually associated with bevacizumab. A new treatment begins at progression.~      In colo-rectal metastatic cancer, it was demonstrated that the first-line of treatment could~     be administered according to a stop and go strategy respecting therapeutic breaks between~     sequences of identical treatment. During these therapeutic breaks, a treatment of maintenance~     is possibly better than an absence of treatment. These plans benefit to the patients in terms~     of efficiency but also in terms of toxicity, in particular neurological.~      The question is to know if this strategy is feasible in lung cancer.~   "
142264|NCT01705171|"~     In this study we will investigate the expression of the fructose transport protein GLUT5 in~     the small intestine in patients with functional GI disoders and fructose intolerance compared~     to matched healthy controls.~   "
142265|NCT01705158|"~     The purpose of this study is to determine the efficacy and the safety of the association of~     carboplatine and liposomal doxorubicin in patient with ovarian cancer in relapse, sensitive~     to platin.~   "
142266|NCT01705145|"~     The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and~     pharmacodynamics (PD), of ivacaftor in children with cystic fibrosis (CF) who are 2 through 5~     years of age and have a CF Transmembrane Conductance Regulator (CFTR) gating mutation in at~     least 1 allele.~      Part A is designed to evaluate the safety and PK of multiple-dose administration of ivacaftor~     in participants 2 through 5 years of age and to confirm the doses for Part B. Part B is~     designed to evaluate the safety, PK, PD, and efficacy of ivacaftor in participants 2 through~     5 years of age.~   "
142267|NCT01705132|"~     The purpose of the study is to determine if there are certain laboratory tests that can be~     performed to detect substances or features in a child's urine that can be used to measure the~     progress of Alport kidney disease and the effects of treatment. These tests and their results~     could be of use to measure responses to new treatments in future clinical trials.~   "
142268|NCT01705119|"~     The purpose of this study is to investigate how changing from a supine to upright position~     affects gas exchange for patients with hypoxemic respiratory failure.~      The research question is: will oxygen saturation and/or partial pressure of oxygen in the~     blood change when a patient with hypoxemic respiratory failure moves from a supine to upright~     position?~   "
142269|NCT01705106|"~     This clinical trial studies capecitabine and celecoxib in treating patients with solid~     malignancies that are metastatic or cannot be removed by surgery. Drugs used in chemotherapy,~     such as capecitabine, work in different ways to stop the growth of tumor cells, either by~     killing the cells or by stopping them from dividing. Celecoxib may stop the growth of tumor~     cells by blocking some of the enzymes needed for cell growth. Giving capecitabine and~     celecoxib together may be an effective treatment for solid malignancies.~   "
142294|NCT01704768|"~     The prevention and treatment of obesity and mental health disorders in adolescence are two~     major public health problems in the United States today. To address the increasing incidence~     and adverse health outcomes associated with both obesity and mental health problems, a~     theory-based 15 session intervention program entitled COPE (Creating Opportunities for~     Personal Empowerment)/ Healthy Lifestyles TEEN(Thinking, Feeling, Emotions & Exercise), will~     be delivered within high school health classes in order to improve the physical and mental~     health outcomes of 800 culturally diverse adolescents (14 to 16 years of age).~   "
142270|NCT01705093|"~     The prevalence of childhood obesity has been increasing over the past couple of decades.~     Similar to adults, overweight and obesity in young children and adolescents is associated~     with an increased number of cardiovascular risk factors including dyslipidemia, hypertension,~     insulin resistance and Type 2 diabetes. Epidemiological and clinical studies suggest that~     foods and ingredients rich in select flavonoids, such as cocoa, red grape products, tea,~     citrus fruits, and strawberries are protective against the development of cardiovascular~     disease. Strawberries are rich in flavonoids, particularly anthocyanins, flavanols,~     flavonols, ellagic acid and its glucose ester, ellagitanin. A number of in vitro studies have~     observed that these isolated compounds, as well as strawberry extracts have the potential to~     affect outcomes of cardiovascular health, including vascular reactivity, cellular signaling~     and oxidant defense6,7. We hypothesize that strawberry intake will lead to improvements in~     select measures of cardiovascular function in overweight and obese adolescent males.~   "
142271|NCT01705080|"~     The purpose of this post market clinical investigation is to further evaluate the safety and~     performance of the EnligHTN™ Renal Denervation System in the treatment of patients with~     uncontrolled hypertension.~   "
142272|NCT01705067|"~     Assess the safety and efficacy of the JOURNEY II BCS Total Knee System in subjects with~     degenerative knee disease requiring primary total knee replacement.~   "
142273|NCT01705054|"~     The purpose of this study is describe the frequency of chest pain and how chest pain impacts~     patients' quality of life in the outpatients with chronic coronary artery disease in~     contemporary cardiology practice settings.~   "
142274|NCT01705041|"~     The proposed preliminary field evaluation will compare a point-of-care (POC) transaminase~     test with the standard of care test used in an HIV clinic at the Hospital for Tropical~     Diseases in Ho Chi Minh City, Vietnam.~   "
142275|NCT01705015|"~     The aims of this 3-year randomized, single-blinded clinical trial are to compare the effect~     of high and low feedback about performance on the bedside exercise device in heart or liver~     transplantation recipients during the hospitalization immediately after transplantation. The~     hypotheses of the study are heart/liver transplantation recipients who have high feedback~     about performance on the bedside exercise device will progressively increase their level of~     exercise over the course of their hospitalization, more independent in ambulation level,~     better walking speed and 6-minute walk test at discharge, and better cardiorespiratory~     fitness at 4-8 weeks after transplantation than those who receive low feedback. The adult~     patients who newly receive heart or liver transplantation at National Taiwan University~     Hospital will be evaluated for eligibility of the study in the acute postoperative period.~     The study will be conducted in both the intensive care unit and ward environments. The study~     subjects will be randomized to either high or low feedback about performance on the bedside~     exercise device which uses hand/foot pedals that record exerted forces against adjustable~     resistances, measure repetitions of upper and lower extremity cycling movements, and give~     feedback about performance via a wireless internet connection. The study will also monitor~     the amount of daily movement activity of all subjects in this trial by using triaxial~     accelerometers, and the activity recognition algorithms developed by engineers and computer~     scientists at University of California Los Angeles. The outcome measures include level of~     independence for walking, walking speed, 6-minute walk test, and cardiopulmonary exercise~     testing by the blinded observers. The study expects to enroll at least 50 heart~     transplantation recipients and 60 liver transplantation recipients in 3 years. The results of~     this study will offer much insight into activity levels of heart or liver transplantation~     recipients during early postoperative period. Besides, heart transplantation recipients will~     receive routine phase I cardiac rehabilitation program by the physical therapists during the~     study but not liver transplantation recipients. We might be able to evaluate the interaction~     effects of routine physical therapy and UCFit exercise among our study subjects. Our data~     will also provide insight into just how active or inactive transplantation recipients may be~     and help generate ideas of organ transplantation rehabilitation program to increase their~     fitness-related activity prior to discharge.~   "
142276|NCT01705002|"~     This is a Phase I, multi-center, Dose-Escalating, Safety Study of an Intravenously~     Administered Pegylated Liposomal Mitomycin-C Lipid-based Prodrug (PL-MLP, PROMITIL) in Cancer~     Patients with Solid Tumors. The study comprised of:~      Escalated cohorts A-H: 27 male or female participants, ages 18-80, BMI 18-36 diagnosed with~     inoperable, recurrent or metastatic malignant solid tumors, deemed incurable, and who have~     failed to respond to standard therapy or for whom no standard therapy is available. Eligible~     subjects will be assigned, successively in order of accrual, to one of eight cohorts, to~     receive escalating doses of intravenously infused PROMITIL. PROMITIL will be administered as~     an intravenous infusion. Dose escalation will only proceed in the absence of dose-limiting~     toxicity (DLT). For this purpose, each cohort will only begin its first cycle of PROMITIL~     when the cohort preceding it has successfully completed its first 4-week cycle without any~     signs of DLT.~      Expanded cohort: 17 adult patients with metastatic CRC. The purpose of this expanded cohort~     is to further evaluate the safety of Promitil and to search for signs of antitumor activity~     of Promitil in this specific patient population.~      Combination Cohort (Promitil concomitantly with Capecitabine): 23 adult patients with~     metastatic CRC.~      Triple combination Cohort: 13 additional subjects with metastatic CRC, received combination~     of Promitil concomitantly with Bevacizumab (5 mg/kg) on day 1 of a 28 day cycle and~     Capecitabine on days 1-14 of a 28 day cycle.~      3 weekly cohort- 9 subjects with metastatic CRC will receive Promitil and Bevacizumab (7.5~     mg/kg) on day 1 of a 21 day cycle.~   "
142277|NCT01704989|"~     A number of large clinical trials have found pseudoexfoliation (PXF) to be a major risk~     factor for glaucoma progression and risk of blindness. It is estimated that PXF accounts for~     approximately a quarter of cases of open angle glaucoma in Nova Scotia, Canada, making this~     region an ideal setting for studying patients with this condition. Despite associated high~     morbidity, the treatment of pseudoexfoliative glaucoma remains suboptimal and a challenge for~     the clinician. Topical medical therapy is less effective than for primary open angle glaucoma~     and patients often require early surgical therapy, with associated risks. Selective laser~     trabeculoplasty (SLT) may be a safe and effective treatment for pseudoexfoliative glaucoma,~     although the evidence for this is presently lacking. The aim of the current study is to~     provide the first controlled-trial evidence for the effectiveness of SLT, compared to topical~     therapy, in the management of pseudoexfoliative glaucoma.~   "
142278|NCT01704976|"~     This randomized controlled study aims to examine long term effects in the skilling up phase~     over 4 weeks on physical functional performance and strength of mechanical SR-WBV and dance~     therapy intervention in a frail elderly population.~   "
142279|NCT01704963|"~     The purpose of this study is to evaluate the safety and tolerability of Bruton's Tyrosine~     Kinase (Btk) Inhibitor PCI-32765 in Japanese patients with recurrent mature B-cell neoplasms.~   "
142280|NCT01704950|"~     The aim of this study is to provide data and the guidelines for the use of IDRT SL in small~     wounds, acute and chronic (less than 6 months), showing the benefits and the easy to use of~     this product as a one stage procedure.~   "
142295|NCT01704755|"~     The purpose of this study is to evaluate the safety and efficacy of ABT-450/ritonavir/ABT-267~     (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and~     ABT-333 (also known as dasabuvir) coadministered with ribavirin (RBV) in hepatitis C virus~     (HCV) genotype 1-infected adults with compensated cirrhosis.~   "
142281|NCT01704937|"~     Fecal microbiota transplantation (FMT) is the reconstitution of normal flora by a stool~     transplant from a healthy individual to a C. difficile-infected recipient, and has long been~     a successful approach to recurrent/refractory C. difficile. The purpose of this project is to~     generate a frozen FMT inoculum from well-screened healthy volunteer donors which can be used~     repeatedly, particularly in those who do not have a healthy intimate partner or other related~     donor. Delivery of FMT has been performed colonoscopically, by fecal retention enema, or by~     the nasogastric route. This study will evaluate the safety and secondarily the efficacy of a~     frozen inoculum administered by nasogastric tube vs administered by colonoscope.~      Subjects with recurrent/relapsing C. difficile infection (10 per group) will receive FMT via~     either:~        -  colonoscopy~        -  NGT~      The primary endpoint is assessment of safety as measured by clinical events (GI, procedural,~     systemic). Efficacy will be defined as a resolution of diarrhea off antibiotics for C.~     difficile, in the absence of a need for OTHER systemic antibiotics, i.e. resumption of a~     normal bowel status for the individual. Secondary efficacy endpoints include weight,~     subjective well-being and relative clinical improvement per standardized questionnaire, and~     subject qualitative assessment of, and satisfaction with, the transplant procedures. Subjects~     will be monitored for clinical safety by history and standard exams and the follow-up~     questionnaire as well as followed closely by phone and in person.~   "
142282|NCT01704924|"~     This study aims to assess the quality of wound healing in abdominal scars with and without~     the Prevena Incision Management System. The hypothesis is that Prevena will lead to improved~     wound healing with less swelling, bruising, and inflammation, as well as less potential for~     infection, seroma, and dehiscence.~   "
142283|NCT01704911|"~     The purpose of the DRAGON clinical trial is to evaluate the safety and efficacy of the~     transradial coronary intervention (TRI) in comparison with the transfemoral coronary~     intervention (TFI).~   "
142284|NCT01704898|"~     The primary objective of this study is to determine the average bioequivalence of a generic~     efavirenz 600 mg tablet (test formulation)compared with Stocrin(R) 600 mg tablets (Reference~     formulation).The study is designed as an open label, randomized, crossover, 2-treatments,~     2-period, 2-sequence, single dose pharmacokinetic study conducted in healthy volunteers.~     Subjects will be randomized to receive generic efavirenz 600 (Test formulation) or Stocrin(R)~     600 tablets (Reference formulation)on study day 1 (period 1). Subjects will undergo a 24 hour~     intensive pharmacokinetic evaluation after ingesting a single dose of either the Test or~     Reference formulation. Subjects will provide additional pharmacokinetic samples 36, 48, 72,~     120 and 192 hours postdose, respectively. Subjects will complete a wash out period from day 8~     to day 28 during wich no study drug will be ingested. On day 29 subjects will ingest either~     the Test or the Reference formulation (opposite to the formulation received on period 1). All~     subjects undergo another 24 hour intensive pharmacokinetic evaluation and pharmacokinetics~     samples on days 36, 48, 72, 120, 192 pos dose, respectively. Adverse events and and~     concomitant medication will be documented throughout the study.~   "
142285|NCT01704885|"~     The goal of this study is to determine whether a brief (three 20-30 minute session)~     cognitive-behavioral play intervention will improve coping skills and adjustment for siblings~     of children diagnosed with cancer.~   "
142286|NCT01704872|"~     The purpose of this study is to assess the safety, pharmacokinetic and activity profiles of~     the ch14.18 antibody produced in cells of hamster origin (ch14.18/CHO).~   "
142287|NCT01704859|"~     The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a randomized clinical trial in~     25,874 U.S. men and women investigating whether taking daily dietary supplements of vitamin~     D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing~     cancer, heart disease, and stroke in people who do not have a prior history of these~     illnesses. This ancillary study is being conducted among participants in VITAL and will~     examine whether vitamin D or fish oil will (1) reduce incident total fractures and (2) reduce~     incident hip and non-vertebral fractures.~   "
142288|NCT01704846|"~     The objective is to investigate the bioequivalence of 2 dose strengths of 40 mg and 120 mg BI~     201335 NA soft gelatine capsules.~   "
142289|NCT01704833|"~     The main objective of this study is to determine the preliminary efficacy of Paranoia-Focused~     Cognitive Behavioral Therapy (PFCBT) relative to standard care in the treatment of~     persecutory delusions in patients diagnosed with schizophrenia or schizoaffective Disorder.~   "
142290|NCT01704820|"~     Colonoscopy is the gold standard screening test for colorectal cancer. Removal of~     pre-malignant colon polyps during colonoscopy reduces colorectal cancer mortality by over~     50%. However, while colonoscopy is highly effective at preventing distal (left sided) colon~     cancers, it provides only limited protection from cancer in the proximal (right side) colon.~     Our goal is to determine if additional pre-cancerous colon polyps can be identified by~     looking at the right side of the colon in retroflexion. During retroflexion the tip of the~     colonoscope is turned 180 degrees; allowing the doctor to view the backs of colonic folds. If~     additional polyps can be identified in this manner colonoscopy will become a more efficient~     method of screening for colon cancer.~      In order to evaluate how effective right colon retroflexion is at detecting polyps in the~     proximal colon we plan on performing a randomized, controlled trial. Patients undergoing~     screening or follow up colonoscopy will be invited to participate in the study. Those~     patients who agree to participate will be randomized into one of two groups once the~     colonoscope is fully inserted. Group one will have the right side of their colon examined for~     polyps with the endoscope looking forward (traditional form of examination) followed by~     repeat examination of the right side of the colon with the colonosocpe in retroflexion~     (looking backwards). Polyps seen during each section of the exam will be removed and manner~     in which the polyps were found/ removed will be recorded. Following the two exams of the~     right side of the colon the colonoscopy will be completed in the usual manner. The duration~     of each portion of colonoscopy will be recorded. After the procedure is completed the~     physician performing the colonoscopy will rate difficulty of the procedure and confidence~     with quality of the examination. Pathology results for each polyp will be recorded once~     available. There will be no study related follow up after the pathology results are recorded.~   "
142291|NCT01704807|"~     Purpose of study: To assess the effects of wearing custom orthotics as opposed to placebo~     foot inserts on the duration of chiropractic correction of spinal fixations and muscle~     imbalances using applied kinesiology techniques.~   "
142292|NCT01704794|"~     The purpose of this study is to determine the antioxidant effect of prolonged use of sorghum~     bicolor (jobelyn) to increase the level of plasma superoxide dismutase and glutathione~     reductase in patients with sickle cell disease and to determine if there is any improvement~     in the quality of life of the patients.~   "
142293|NCT01704781|"~     During the course of HIV infection the number of CD4 cells decreases, resulting in a reduced~     immunological response and ultimately immune deficiency. Vacc-4x is a peptide-based HIV~     immunotherapy and the primary objective is to strengthen the immune system's response to HIV~     p24. By adding Lenalidomide, an immunomodulatory agent, as a supporting drug, it is~     anticipated that the effect of Vacc-4x might be enhanced.~   "
142296|NCT01704742|"~     This study will help researchers learn more about non-Hodgkin's lymphoma and Hodgkin's~     lymphoma and how it is treated in Kenya. Researchers want to see if having certain viruses~     like Epstein Barr Virus (EBV), Human Immunodeficiency Virus (HIV), and Kaposi's Sarcoma~     Herpes Virus (KSHV) affects lymphoma. Patients in Kenya who agree to be in this study will~     let the resesarchers look at their medical record, follow their normal cancer care, and have~     blood drawn to look at different proteins and viruses. Researchers would also like to look at~     part of the original tumor that was taken out of each patient. Some of these samples will be~     stored at Kenyatta National Hospital and research will be done on them later. This study does~     not involve any change in treatment, but only allows the study team to follow how a patient~     in Kenya with lymphoma is treated.~   "
142297|NCT01704729|"~     Phase I: Focus groups on different designs of adjustable glasses and standard glasses~     (August-September 2012) Phase II: Two-month randomized trial comparing four groups:~     (September 2012 - August 2013)~   "
142298|NCT01704716|"~     This is a randomised study of the European SIOP Neuroblastoma Group (SIOPEN) in high-risk~     neuroblastoma (stages 2, 3, 4 and 4s MYCN-amplified neuroblastoma, stage 4 MYCN non amplified~     > 12 months at diagnosis).~      The protocol consists of a rapid, dose intensive induction chemotherapy (R3 randomisation -~     Rapid COJEC vs modified N7), peripheral blood stem cell harvest, attempted complete excision~     of the primary tumour, myeloablative therapy (BuMel) followed by peripheral blood stem cell~     rescue, radiotherapy to the site of the primary tumour and immunotherapy (R4 randomisation -~     isotretinoin and ch14.18/CHO, with or without aldesleukin (IL-2).~      In the induction phase, all patients with stage 4 neuroblastoma and those with stage 4s~     MYCN-amplified neuroblastoma will be randomised (R3) to Rapid COJEC or modified N7; localised~     patients receive Rapid COJEC (Rapid COJEC is given with G-CSF support based on the results of~     the R0 randomisation running between 2002 and 2005).~      Following induction treatment peripheral blood stem cell harvest (PBSCH) will be performed~     and complete excision of the primary tumour will be attempted.~      Patients with an inadequate metastatic response to allow BuMel MAT followed by PBSCR at the~     end of induction should receive 2 TVD (Topotecan, Vincristine, Doxorubicin) cycles.~      After Rapid COJEC induction, localised patients will proceed to consolidation. Patients aged~     12-18 months at diagnosis, with stage 4 neuroblastoma, no MYCN amplification and without~     segmental chromosomal alterations (SCA) are thought to have a good prognosis and will stop~     treatment after induction therapy and surgery to the primary tumour.~      Consolidation consists of BuMel MAT (following the results of the R1 randomisation) followed~     by peripheral blood stem cell rescue (PBSCR) and radiotherapy to the site of the primary~     tumour.~      During the immunotherapy phase, patients will be randomised (R4) to immunotherapy with~     isotretinoin (13-cis-RA) and ch14.18/CHO, with or without aldesleukin (IL-2).~   "
142299|NCT01704703|"~     Open label Phase II study of FOLFIRI + Panitumumab using ultra-selection technology with next~     generation high sensitivity genotyping of patients with stage IV colorectal cancer refractory~     to irinotecan without any mutation on KRAS, PIK3Ca, BRAF and NRAS genes detected with highly~     sensitive techniques.~   "
142300|NCT01704690|"~     Esophageal cancer is one of the common malignant disease, especially in China. The annual~     incidence of esophageal squamous cell carcinoma is 260,000 with the motility of 210,000. The~     prognosis of esophageal cancer is very poor. About 50% of patients have advanced disease at~     diagnosis and the natural course is only 6-8 months with a 5-year survival rate of 5-7%.~     Though some patients received surgical treatment, disease will recurrent and metastasis in~     nearly 90% of the patients.~      In past decades, there isn't much improvement of the outcome and survival of advanced~     esophageal cancer due to the lack of effective chemotherapy agents. The traditional~     chemotherapy drugs include 5-fluorouracil and cisplatin and the combination of them results~     in a 25-35% response rate in both first-line and palliative treatment. Paclitaxel plus~     cisplatin regiment is another promising treatment of esophageal cancer and have been proved~     effective in many studies. One of our previous study showed paclitaxel and cisplatin~     treatment resulted in encouraging response rate with manageable side-effects in 131 patients~     of advanced esophageal cancer.~      However, the toxicities of paclitaxel and cisplatin limit their combination in clinic. For~     example, the polyoxyethylene castor oil paclitaxel could induce acute hypersensitivity~     reactions and neurotoxicity. Cisplatin could result in dysfunction of kidney and~     neurotoxicity. In addition, most of esophageal cancer patients are age 65 to 70. Many of them~     have simultaneously other diseases such as hypertension, diabetes, and chronic kidney disease~     which cause varying damages of renal function and limit the use of cisplatin in these~     patients. Therefore, it is urgent for doctors to seek an alternative of cisplatin in the~     combination chemotherapy treatment.~      Therefore, the investigators designed this randomized clinical trial in which a novel~     combination of S-1 with paclitaxel is used to treat advanced esophageal cancer patients in~     compare with paclitaxel/cisplatin and 5-FU/cisplatin treatment to explore its efficacy and~     toxicity. The investigators hope this study will provide some clues for the treatment of~     esophageal cancer patients.~   "
142301|NCT01704677|"~     During the past 25-30 years, surgery with total disc replacement (TDR) has become an option~     for a selection of patients with chronic low back pain (LBP) traditionally treated~     conservatively or operated on with spinal fusion. Randomized trials comparing TDR with fusion~     have found the clinical outcome of TDR at least equivalent to that of fusion, and the only~     study comparing TDR to non-surgical treatment (The Norwegian TDR study) concludes that TDR is~     significantly more effective than multidisciplinary rehabilitation (REHAB) after 2 years.~     However, the long-term effects of TDR in terms of clinical results, costs, reoperation- and~     revision rate, degenerative changes and prognostic factors have not been investigated in high~     quality prospective trials. This is very much required since TDR surgery is offered a great~     number of patients world wide, and is associated with high complexity and risk of serious~     complications and difficult revision. Hence, the overall aim of the present study is to~     evaluate the long term (eight years follow-up) effect of The Norwegian TDR study where TDR~     surgery were compared to modern multidisciplinary rehabilitation in patients with chronic low~     back pain and localized degenerative disc changes.~   "
142302|NCT01704664|"~     Perioperative immunonutrition in gastric cancer patients can reduce perioperative morbidity~     and may improve quality of their life. Patients with gastric cancer will be divided into four~     groups depending on the type of artificial nutrition. Group I (enteral feeding) and II~     (enteral feeding and parenteral nutrition with glutamine) will be administered nutritional~     therapy during the postoperative period, group III (oral arginine) and IV (parenteral~     immunonutrition) patients will be treated nutritionally both prior to and after the surgery.~     The lymphocytes and their subpopulations, interleukin IL-1B,-6,-23, and the phagocytic, and~     bactericidal activity of blood platelets will be determined before and after nutritional~     therapy.~   "
142303|NCT01704651|"~     This study is designed to determine whether an oral perioperative medication (alvimopan--a~     selective mu antagonist) improves bowel recovery over placebo after surgery for ovarian~     cancer.~   "
142304|NCT01704638|"~     The investigators will compare plasma kinetics of two marker drugs in individuals with~     different genetic variations in the MDR1-gene. The hypothesis is that one group will have~     higher exposure than the other.~   "
142317|NCT01704469|"~     Opioid-induced hyperalgesia (OIH) is most broadly defined as a state of nociceptive~     sensitization caused by exposure to opioids. In humans, the evidence of OIH is strong but~     conflicting. Previous clinical studies mostly used experimental or non-standardized surgical~     stimuli to assess OIH. We therefore sought to certify a presence of OIH using a standardized,~     clinical pain stimuli in cancer patients receiving opioid therapy and opioid-naive patients.~   "
142358|NCT01703936|"~     This project is an evaluation of an agricultural training and resettlement program for~     high-risk young adults in Liberia, especially poorly integrated male ex-combatants. The~     primary aim is to see to what extent an intensive economic and life skills intervention can~     rehabilitate high-risk individuals and reduce aggression and armed violence.~   "
142305|NCT01704625|"~     PURPOSE The purpose of this research is to determine whether osteopathic manipulative therapy~     (OMT) is a useful adjunct in evaluation and treatment of headaches.~      PROCEDURES If a practitioner determines that a patient has a significant headache he/she may~     order tests. He/ She may give the patient medications to treat the headache.~      The investigators will also ask permission to evaluate and treat the headache using~     osteopathic evaluation and Osteopathic Manipulative Treatment (OMT). The bedside evaluation~     and treatment will be performed by an emergency medicine resident. Osteopathic evaluation and~     OMT is not standard of care for this condition. The investigators also may call the patient~     in 7 days to see how they are doing.~      The investigators wish to see if emergency medicine physicians can use osteopathic evaluation~     and OMT to reliably treat headaches. The results of the examination and treatment will be~     recorded, but will not be used to change treatment or to change additional tests. The~     investigators wish to see whether in the future they can use OMT in certain cases instead of~     or in conjunction with medications. The investigators plan on asking 50 patients to~     participate.~   "
142306|NCT01704612|"~     Diabete animal studies demonstrated a longer period recovery after local anesthetic injection~     (perineural administration). No clinical study demonstrated a prolonged nerve block duration~     in diabete type 2 patients after peripheral nerve block. The investigators hypothesized that~     block recovery is delayed in diabetic patients.~   "
142307|NCT01704599|"~     Vitamins modulating homocysteine affect both TNF-alpha, vascular endothelial growth factor,~     and theoretically enhance the anti-inflammatory version of NOS thus hopefully increasing the~     efficacy and reducing the chance of some toxicities of adalimumab as determined by blood~     testing and EKGs.~   "
142308|NCT01704586|"~     Thyroid nodules are a common clinical problem. Epidemiologic studies have shown the~     prevalence of palpable thyroid nodules to be approximately 5% in women and 1% in men living~     in iodine-sufficient parts of the world and up to 30% in iodine deficient regions, such as~     Germany. The clinical importance of thyroid nodules rests with the need to exclude thyroid~     cancer which occurs in 5-15%. Differentiated thyroid cancer (DTC), which includes papillary~     and follicular cancer, comprises the vast majority (90%) of all thyroid cancers. In Germany,~     approximately 7,000 new cases will be diagnosed in 2011. The yearly incidence has increased~     from 3.6 per 100,000 in 1973 to 8.7 per 100,000 in 2002, and this trend appears to be~     continuing. Recurrence-free survival is generally excellent and depends on the risk group.~      The role of postoperative remnant radioiodine ablation (RRIA) as the most serious question~     regarding the initial management of DTC still needs to be resolved even after decades of~     radioiodine use. American Thyroid Association directions for future research addressing these~     questions include:~        -  Better understanding of the long-term risks of radioiodine use;~        -  Improved risk stratification;~      Randomized controlled trials are still missing in which RRIA has proven its worth as a safe~     and very effective treatment that results in an improved life expectancy and a reduced~     recurrence rate. Many observational studies lack sufficiently high evidence. Evidence grade~     is rated mainly on expert level, based on non-randomized retrospective observation studies.~     Although RRIA in Europe is established as adjuvant standard treatment for all patients with~     DTC, except those with stage T1a, it remains to be shown throughout if it is beneficial for~     low risk and medium risk patients without metastases (M0), also known as stage I patients~     according to UICC/AJCC classification, accounting for 40-90% of all patients.~      Blood doses due to cumulative radioiodine therapy may well exceed 2 Gy, and RRIA induces an~     average blood dose of 0.28 Gy to the entire body. Risks as estimated from that dose are not~     insignificant. The question is whether or not the condition after remnant ablation justifies~     such an increased risk of a secondary malignancy. The probability of causation for a~     pharyngeal or breast tumour can well exceed the margin of a 50% after being exposed to RRIA~     or consecutive I-131 diagnostic imaging to explore measureable Tg levels. Even though~     radioiodine therapy can benefit some patients with advanced thyroid carcinoma, it is still~     unknown whether the risks of RRIA outweigh any discernable benefit. Undoubtedly, quality of~     life may be affected by adjuvant use of I-131.~      Study Hypothesis:~      The I-124 study arm may have considerable benefits for the patient included in the study.~     These include~        -  enhanced tumour and risk stratification,~        -  avoidance of unnecessary I-131 exposure in 30-89 percent of patients who were classified~          with low risk tumour (MACIS or AMES scoring) or stage I disease (UICC-AJCC TNM~          staging system), and,~        -  improved quality of life at the same or better morbidity and mortality rates in the~          I-124 arm.~      Environmental and hospital staff related benefits include prevention or saving of I-131~     exposure.~      This study is designed to compare effectiveness of treatments following and evaluating~     guideline recommendations in two assignment arms.~   "
142309|NCT01704573|"~     This positron emission tomography (PET) study examines the effects of 24 hours abstinence~     from smoking on return to availability of neuronal nicotinic receptors in slow and fast~     metabolizers of nicotine.~   "
142310|NCT01704560|"~     Well-informed potential subjects are presumably better able to make autonomous decisions~     about the risks and benefits of participating in a research study than those in possession of~     less information. In actuality, prior research into consent understanding suggests that~     longer forms offering exhaustive information may inhibit rather than promote understanding.~     Moreover, technical wording in tools used to measure parent understanding of research~     permission may also lead to inhibition of understanding. This study will test the hypothesis~     that, among parents of potential subjects for greater-than-minimal-risk research, two~     modified and simplified subset of questions from the Deaconess Informed Consent Comprehension~     Test (DICCT), one oral and open-ended and one written and multiple choice, will increase~     subject understanding of the nature and risks of the research. The study will enroll the~     parents of 40 potential neonatal research subjects with an interim analysis of data at 20~     subjects. Subjects will review a sham research permission form and will be randomized 1:1 to~     complete one of the two modified comprehension tests in addition to the DICCT (gold-standard)~     test. Parents will be given an open-ended survey after the tests in order to qualitatively~     describe their opinions of each test. A subset of parents who have received the written form~     will also undergo a cognitive interview about the form. A similar subset will also be given~     an open-ended survey about a proposed permission form cover sheet. The primary outcome will~     be the correlation of scores between the DICCT and modified comprehension tests, following~     the sham informed consent process.~   "
142311|NCT01704547|"~     The study is designed to assess the accuracy of patient breast reproducibly using the revised~     BCID. This study would provide data for target verification and quality assurance to~     eventually allow treatment of breast cancer patients for either a TBB or accelerated partial~     breast irradiation. The BCID is a low-risk device similar to immobilization devices used~     routinely in radiotherapy for other disease sites.~   "
142312|NCT01704534|"~     The purpose of this study is to determine whether ustekinumab is effective in the treatment~     of moderate to severe hidradenitis suppurativa.~   "
142313|NCT01704521|"~     This study will examine viral dynamic responses in subjects with chronic hepatitis C and~     hemophilia when treated with pegylated interferon + ribavirin and telaprevir.~   "
142314|NCT01704508|"~     Plasmodium falciparum causes malaria and approximately 665 000 deaths each year. chloroquine~     and sulphadoxine-pyrimethamine resistant P. falciparum are widespread. An artemisinin~     derivative combined with lumefantrine, amodiaquine or piperaquine is therefore recommended~     for the treatment of malaria in Africa. However, artemisinin resistance appears to be~     developing and resistance/tolerance to amodiaquine and lumefantrine exists. We are presently~     conducting a study in Guinea-Bissau. Preliminary data indicates that the effectiveness and~     availability of artemether-lumefantrine (AL), the 1st line drug, is poor. Consequently there~     is a need for another treatment option. Dihydroartemisinin-piperaquine (DP) has been shown to~     be efficacious and well tolerated in several African countries and is therefore such an~     option. A clinical trial comparing the safety and efficacy of artemether-lumefantrine and~     dihydroartemisinin-piperaquine is therefore needed.~      Parents to children seeking Bandim Health Centre (CSB) with symptoms compatible with malaria~     will be informed of the study. If accepting and the child fulfil the inclusion criteria, the~     child will be randomised to treatment with either AL or DP. The treatment will be given~     supervised at the health centre in the morning and the evening on day 0, day 1, and day 2.~      At each visit and in the morning on day 3, the child will be examined, the mother asked for~     any symptoms and signs of side-effects, the temperature measured. Furthermore, a blood sample~     will be taken for examination of malaria parasites. On day 0 samples for measurement of~     antimalarial drugs and for genotyping of the parasites will be taken on filterpaper. In a~     subgroup of 50 children a blood sample for in vitro culturing and for analysis of the number~     of leucocytes will also be taken.~      After having finished the treatment the children will be followed on day 7 and then once a~     week until day 42. At each visit the condition of the child will be examined and a~     bloodsample taken for examination of parasites in the blood. Furthermore, a filterpaper~     bloodsample will be collected for measurement of the drug concentration of if the child has~     recrudescence for genotyping of the parasites. On day 0, 3 and 42 the haemoglobin level will~     be examined.~      The result of the two treatments will be evaluated by comparing the number of children with~     recurrent parasitaemia, both corrected and uncorrected (recrudescence vs. reinfections). This~     will be presented as adequate clinical and parasitological response rates PCR-corrected and~     PCR-uncorrected. Furthermore, the chance in haemoglobin level from day 0 till day 3 and till~     day 42 will be compared. The concentration of the antimalarial drug in the blood samples~     taken at the visit before the re-parasitaemia will be capered to the concentrations in~     children without re-parasitaemia.~      Assuming a 20% loss to follow up a total of 346 children should be included. For the children~     included, health care and medications at Bandim Health Centre will be free during the study~     period but no other gifts or payments will be made.~      Results will be presented to the staff at the Bandim health centre and the ministry of Health~     and will be published in an international peer reviewed journal.~   "
142315|NCT01704495|"~     The purpose is to Evaluate the Efficacy, Safety, and Tolerability of 3 Different Doses of~     AZD5069 Twice Daily as Add-on Treatment to Medium to High Dose Inhaled Corticosteroids (ICS)~     and Long-acting β2 Agonists (LABA), in Patients with Uncontrolled Persistent Asthma~   "
142316|NCT01704482|"~     We aim to investigate the efficacy of N-acetylcysteine (NAC) to attenuate acute renal~     dysfunction in patients with rheumatic valvular heart disease undergoing single valve~     replacement.~   "
142318|NCT01704456|"~     This randomized trial, nicknamed the COMFORT (Cognitive therapy or Mindfulness FOR Treatment~     of pvd) study, will compare the effects of an 8-session group Mindfulness-based Cognitive~     Therapy (MBCT) to an 8-session group Cognitive Behavioural Therapy (CBT) for women with~     provoked vestibulodynia (PVD). Women with PVD will be randomly assigned to attend either~     eight sessions of group MBCT or CBT. Each session is 2.25 hours long and spaced 1 week apart.~     The purpose of this study is to determine whether the 8-session MBCT intervention for PVD is~     no worse than an 8-session CBT intervention for decreasing women's pain intensity, sexual~     distress, catastrophizing and hypervigilance towards pain.~   "
142319|NCT01704443|"~     This study aims to test the efficacy of a 4-session intervention (Group psychoeducational~     treatment) using a randomized study design. Participants will be randomized in to 'immediate~     treatment' or 'waitlist control'. Women in the wait-list condition will receive the 4-session~     IMPROVED treatment, just as women randomized to the experimental group, after the end of~     their wait-list period.~   "
142320|NCT01704430|"~     Patients undergoing heart surgery with a heart-lung machine (termed cardiopulmonary bypass)~     are at an increased risk of having abnormal inflammation in their body after surgery. Such~     inflammation can contribute to slower recovery from surgery, an increased risk of infection,~     an increased risk of damage to organs other than the heart, and a more complicated course.~      Prior research has suggested that using an oral protein supplement made of glutamine (an~     essential amino acid normally found in your body) can reduce the risk of inflammation,~     infection and the length of stay in hospital in patients who have suffered major trauma or a~     burn injury. The investigators believe reducing such inflammation after heart surgery may~     help promote recovery and reduce the risk of adverse events and complications.~      The purpose of this preliminary study is to see if oral glutamine supplementation after heart~     surgery is practical, and contributes to a reduction in inflammation. The oral glutamine~     proposed in this study is based on what has been previously studied and what is considered~     safe.~   "
142321|NCT01704417|"~     This trial is conducted in Europe. The aim of the trial is to compare the effect of exercise~     on blood glucose in subjects with type 1 diabetes, who are treated with either insulin~     degludec (IDeg) or insulin glargine (IGlar).~   "
142322|NCT01704404|"~     This study will characterize the dose response of TD-4208 after 7 days of dosing in subjects~     with Chronic Obstructive Pulmonary Disease (COPD).~   "
142323|NCT01704391|"~     Open elective abdominal aortic surgery is a high risk procedure involving clamping of the~     aorta. Indications include abdominal aortic aneurysm (AAA) or aortic occlusive disease (AOD)~     causing lower limb ischaemia.~      These patients are often regarded as one entity in postoperative study settings. However,~     previous studies indicate that risk profiles, inflammatory activity, and haemodynamic~     capacity may differ between these groups. The first aim of this study was to evaluate~     postoperative ICU-requirements after open elective abdominal aortic surgery, hypothesising~     that AAA-patients had longer ICU-stays and needed more mechanical ventilation or acute~     dialysis than did patients with AOD.~      The investigators see a relatively high incidence of postoperative acute kidney injury (AKI)~     following aortic surgery. Neutrophil Gelatinase Associated Lipocalcin (NGAL) may be useful in~     the early diagnosis of postopeative AKI. However, NGAL is also known as a marker of~     inflammatory activation. The ischaemia-reperfusion injury and subsequent inflammatory~     response to aortic cross clamping may per se induce a rise in NGAL despite intact renal~     function. Therefore NGAL may not be a reliable marker of AKI after AAS.~      The second aim of this study is to describe the changes in NGAL after AAS in patients with~     and without postoperative dialysis-dependent AKI.~   "
142324|NCT01704378|"~     This trial is conducted in Europe. The aim of this trial investigate the the long-term safety~     of biphasic insulin aspart 30 in subjects with type 2 diabetes.~   "
142325|NCT01704365|"~     The purpose of this study is to evaluate the immunogenicty and safety of an RSV-F protein~     nanoparticle vaccine, with out without aluminum, in healthy women of child-bearing potential.~   "
142326|NCT01704352|"~     Patients with bipolar disorder suffer from sleep disturbances, even in euthymic phases.~     Changes in sleep are frequent signs of a new episode of (hypo)mania or depression. Cognitive~     behavioral therapy for insomnia is an effective treatment for primary insomnia, but has not~     been introduced to patients with bipolar disorder. The aim is to compare cognitive behavioral~     therapy added to 'treatment as usual' with just 'treatment as usual'. The investigators~     hypothesize that cognitive behavioral therapy will improve quality of sleep, stabilize minor~     mood variations and prevent new mood episodes in euthymic patients with bipolar disorder and~     insomnia.~   "
142327|NCT01704339|"~     Critical ischaemia is pain at rest as the result of poor blood flow and lack of oxygen being~     delivered to the tissues. It normally affects the hands and feet and can be very~     debilitating. It is particularly common and difficult to treat in patients with end stage~     renal failure~      Patients with renal failure are often high risk of any operative intervention which might~     help the pain. Often the only treatment options are painkillers. Unfortunately however, the~     commonly used painkillers, for example morphine, are known to cause worse side effects in~     patients with renal failure (drowsiness, confusion etc.~      Qutenza (topical capsaicin 8%) is a new treatment made from chilli peppers which is applied~     to the skin as a patch and works directly at the nerve endings in the skin to prevent pain.~     It therefore should not have the systemic side effects of other drugs. It has been~     demonstrated to be beneficial in other painful conditions for example post-shingles pain and~     nerve pain from HIV. It has never been used for critical ischaemia before.~      We propose to investigate the efficacy of Qutenza in treating patients with end stage renal~     failure and painful ischaemia. We will recruit 20 patients with painful ischaemia and treat~     them with Qutenza. We will follow them up for 12 weeks and monitor the change in their pain~     scores.~   "
142328|NCT01704326|"~     This is a prospective, multicenter, consecutive clinical study of the Journey Deuce Knee~     System and is intended to evaluate the safety and effectiveness of the new device.~   "
142357|NCT01703949|"~     This phase II pilot trial studies how well brentuximab vedotin with or without nivolumab~     works in treating patients with CD30+ lymphoma that has come back after a period of~     improvement or does not respond to treatment. Biological therapies, such as brentuximab~     vedotin, may stimulate the immune system in different ways and stop cancer cells from~     growing. Monoclonal antibodies, such as nivolumab may interfere with the ability of tumor~     cells to grow and spread. Giving brentuximab vedotin with or without nivolumab may work~     better in treating patients with CD30+ lymphoma.~   "
142329|NCT01704313|"~     Patients with end-stage renal failure require dialysis to remove toxins from their blood.~     Haemodialysis is best provided through a native arterio-venous fistula (AVF). Creation of an~     AVF requires a short (~1hr) surgical procedure to join the artery and vein together.~      There are limited potential sites for fistula creation. Generally it is preferrable to~     utilise the most distal sites at the wrist first, as more proximal elbow procedures preclude~     subsequent use of the wrist should the initial fistula fail. The small diameter of artery and~     vein at the wrist requires precise surgical technique.~      There are two potential techniques in common use for creating the arterio-venous anastomosis~     (the join between artery and vein) - continuous suturing and interrupted sutures. Whilst~     there are theoretical advantages to the interrupted technique, it is uncertain if these~     translate clinically into better success of creating the fistula. The aim of this study is~     therefore to compare the clinical success of the two techniques.~   "
142330|NCT01704300|"~     The association between obesity and cardiovascular disease (CVD) has mostly been studied~     using broad endpoints or have focused on cause-specific mortality. The investigators aim to~     compare the effect of body mass index (BMI) on different types of initial presentation of~     CVD.~   "
142331|NCT01704287|"~     This study is being done to compare survival using pembrolizumab (SCH 900475, MK-3475) or~     standard chemotherapy for participants with advanced melanoma (MEL) who have progressed after~     prior therapy. Participants were initially randomized to receive either low dose~     pembrolizumab, higher dose pembrolizumab or Investigator-choice chemotherapy (ICC). The~     randomization to either pembrolizumab or Investigator choice chemotherapy was conducted in an~     open-label fashion.~      The pembrolizumab dose was initially blinded to Investigators and participants until~     Amendment 03. With Amendment 03, all ongoing pembrolizumab participants will be treated with~     open-label, fixed dose pembrolizumab 200 mg every 3 weeks (Q3W), instead of weight-based~     dosing of pembrolizumab.~      The four standard chemotherapy choices were carboplatin + paclitaxel, paclitaxel alone,~     dacarbazine, or temozolomide. Participants on standard chemotherapy who experienced disease~     progression may have been eligible to crossover to treatment with pembrolizumab provided they~     met protocol-specified requirements for crossover. With Amendment 03, all crossover~     participants will be treated with open-label, fixed dose pembrolizumab 200 mg Q3W instead of~     weight-based dosing of pembrolizumab.~   "
142332|NCT01704274|"~     Prostate cancer is the most commonly diagnosed cancer in men in Canada. Over 30% of men over~     the age of fifty have histological evidence of prostate cancer on biopsy. Despite the stage~     migration afforded by early detection with serum prostate specific antigen (PSA) testing and~     an apparent trend toward improved survival over the past several years, prostate cancer~     remains a significant cause of morbidity and mortality. Biochemical failure after primary~     therapy (surgery or radiation) remains a significant health care burden and strategies to~     delay clinical prostate cancer progression and prolong the interval from treatment failure to~     systemic therapy would be of significant clinical benefit for those men suffering from a~     finding of PSA recurrence.~      PSA is widely accepted as the most useful prognostic marker of prostate cancer progression,~     particularly after primary therapy with radical surgery or radiation. 5 Despite improved~     cancer control rates with definitive management of early stage prostate cancer, a PSA~     recurrence is unfortunately a common occurrence (25-50%) in most large case series.~      Microenvironmental factors have been demonstrated to play a pivotal role in the selection of~     neoplastic cell subpopulations expressing more malignant phenotypes and contributing to the~     progression of localized and metastatic disease. Very low levels of O2 (< 10 mmHg) has been~     well described in many solid tumours (including prostate cancer) and the extent of hypoxia~     has been demonstrated to represent an independent marker of a poor prognosis for patients~     with various types of cancers. Tumour hypoxia contributes to numerous adaptive phenotypes~     including increased invasion and metastasis, as well as evasion of immune cell surveillance~     increased resistance to radiotherapy and chemotherapy. Although cellular adaptive responses~     to hypoxia are likely mediated by various mechanisms, our previous preclinical studies~     suggest that decreased nitric oxide (NO)-dependent signalling plays a significant role in~     this progression of a malignant phenotype.~   "
142333|NCT01704261|"~     This study will examine the safety and efficacy of the addition of omarigliptin in~     participants with type 2 diabetes mellitus with inadequate glycemic control on metformin and~     glimepiride. The primary hypothesis is that after 24 weeks, the addition of treatment with~     omarigliptin provides a greater reduction in hemoglobin A1c (A1C) compared with the addition~     of placebo.~   "
142334|NCT01704248|"~     To investigate if the Eye Drop Guide more effective than carefully instructed routine~     technique for chronic glaucoma patients to self-instill eye drops.~      And what factors are associated with the failure of self-instillation eye drops with the Eye~     Drop Guide?~   "
142335|NCT01704235|"~     The purpose of this protocol is to understand the extent of symptom perception and preventive~     care-seeking among Vietnamese American women and their impact on cervical cancer screening~     from the perspectives and experiences of key informants including primary health care~     providers and Vietnamese American women (VAW, foreign-born and United States-born). With this~     information, the investigators can better understand how to promote cervical cancer screening~     in the Vietnamese community.~   "
142336|NCT01704222|"~     Direct DNA amplification, viral isolation and specific antibody measurement in saliva from~     children attending nursery in France Sample collection will be done by the pediatrician the~     nurse, or one of the authorized investigators of the study.~   "
142337|NCT01704209|"~     The purpose of this study is to find out if autologous (your own) fibroblast injections are~     effective for the treatment of acne scars and wrinkles.~   "
142338|NCT01704196|"~     The objective of this study is to evaluate the safety and efficacy of Nepicastat in improving~     the number of subjects that achieve abstinence from cocaine and reducing cocaine use in~     subjects with cocaine dependence.~   "
142339|NCT01704183|"~     The purpose of this study is to study the effect of fingolimod on cardiac autonomic~     regulation in patients with relapse-remitting multiple sclerosis.~      This will be done by measuring heart rate variability from the 24-hour Holter recording and~     myocardial ventricular repolarisation patterns from the 12-lead electrocardiogram tracings.~      The fingolimod treatment is prescribed according to the accepted drug label.~   "
142340|NCT01704170|"~     This study is a prospective, multi-center trial wherein each included subject will receive~     the experimental externally focused ultrasound renal denervation therapy. It will be~     conducted on a maximum of fifty patients who meet the inclusion and exclusion criteria and~     have signed the informed consent form. Safety is the primary endpoint of this study and will~     be assessed by incidence and evaluation of any serious adverse effects associated with the~     investigational procedure through the 52-week evaluation. Clinical utility is the secondary~     endpoint of this study and will be evaluated by assessing pre and post therapy systolic and~     diastolic blood pressure.~   "
142341|NCT01704157|"~     A proof of concept study to evaluate the feasibility of safe and effective treatment through~     optimization of the Cryo-Touch III device for temporary relief of pain.~   "
142342|NCT01704144|"~     Efavirenz is an essential component of HIV treatment in children aged 3 years or older on~     anti-tuberculosis (anti-TB) treatment. However, the appropriate efavirenz dose during anti-TB~     treatment remains unclear. Rifampin (an anti-TB drug) increases the activity of the drug~     metabolizing enzymes that breakdown efavirenz, which may lead to low blood levels of~     efavirenz and treatment failure during cotreatment. The drug-to-drug interactions between the~     HIV and anti-TB drugs also vary between individuals based on genetic factors. This study will~     investigate the effects of anti-TB treatment, as well as drug-gene interactions on the blood~     concentrations of efavirenz in children with HIV and TB infections. Such data could enhance~     optimization of efavirenz dosage or selection of alternate regimens in some children.~   "
142343|NCT01704131|"~     Levosimendan is a drug used in patients with heart failure and has several advantages over~     other heart failure drugs. A lot of research has been done with Levosimendan in Adults, and~     the way the body handles the drug (pharmacokinetics) and responds to the drug~     (pharmacodynamics) are well established. But, in children this information is lacking despite~     the fact that Levosimendan is increasingly used in children of all ages. The investigators~     aim to describe which Levosimendan dose leads to which drug levels in children of different~     ages.~   "
142344|NCT01704118|"~     Objective of this prospective, randomized and controlled study is to compare the performances~     of recently-released size 1 I-gel and size 1 PLMA proven to be superior to classical LMA with~     prospective studies. In this study, primer endpoint was value of airway leak pressure and~     secondary insertion time, insertion success and conditions, initial airway quality,~     hemodynamic parameters, fiberoptic view and complications will be assessed.~   "
142345|NCT01704105|"~     The purpose of this study is to measure the independent and combined effects of interventions~     that improve sanitation, water quality, handwashing, and nutrition on child health and~     development in the first years of life.~   "
142346|NCT01704092|"~     The investigators hypothesized that dexmedetomidine as an anesthetic adjunct can be used in~     the setting of off-pump coronary bypass procedure and can provide benefits to cardiac~     function and cognitive performance on the ground of the dexmedetomidine's characteristics.~   "
142347|NCT01704079|"~     This study will evaluate the efficacy of CTAP101 Capsules versus placebo in reducing intact~     parathyroid hormone (iPTH) by at least 30% from pretreatment baseline; safety and~     tolerability of CTAP101 will also be evaluated~   "
142348|NCT01704066|"~     The original American-European Consensus Conference (AECC) definition of Acute Respiratory~     Distress Syndrome (ARDS) required bilateral infiltrates consistent with pulmonary edema on~     frontal chest X-ray (CXR), but there is poor inter-observer reliability in interpreting CXR~     using this definition among intensivists and radiologists.~      As a result, the newly published Berlin definition of ARDS specified that the CXR criterion~     should include bilateral opacities consistent with pulmonary edema not fully explained by~     effusions, lobar/lung collapse, or nodules/masses on CXR.~      In order to improve inter-observer agreement, the panel have also developed a set of CXRs~     judged as consistent, inconsistent, or equivocal for the diagnosis of ARDS.~      The objective of this study is to investigate the impact of this training set on~     inter-observer reliability in applying the radiographic definition for ARDS.~   "
142349|NCT01704053|"~     The purpose of this study is determine whether point of care coagulation testing is able to~     map the anticoagulatory effects of new oral anticoagulants dabigatran and rivaroxaban. Used~     as devices are thrombelastometry/-graphy (ROTEM, TEG)and multiple platelet function analyzer~     (Multiplate).~   "
142350|NCT01704040|"~     The main purposes of this study are to evaluate the safety (Parts 1 and 2) and efficacy (Part~     2) of pretreatment with CNTO 3157 in healthy adult and asthmatic adult participants before~     and after intranasal (into the nose) inoculation with human rhinovirus type 16 (HRV-16).~   "
142351|NCT01704027|"~     The purpose of this study is to evaluate the incidence of urinary and rectal acute side~     effects of a pelvic and prostatic intensity-modulated arctherapy with simultaneous integrated~     boost (SIB-IMRT)combined with long-term androgen deprivation for patients with high risk~     localized prostate cancer~   "
142352|NCT01704014|"~     Intraoperative floppy iris syndrome (IFIS) is a recently described condition observed during~     cataract surgery. It has been hypothesized that irreversible atrophy of the iris dilator~     muscle associated with α1-adrenergic receptor antagonists (α1-ARA) is responsible for IFIS.~     However the prevalence of IFIS in Korean population is not reported. The purpose of this~     study is to evaluate the prevalence and clinical manifestations of IFIS in relation to iris~     anatomical change in Korean patients taking α1-ARA.~   "
142353|NCT01704001|"~     To investigate the impact of impaired renal function on the pharmacokinetics of ART-123 in~     patients with Disseminated Intravascular Coagulation.~      To investigate the safety of ART-123 in patients with Disseminated Intravascular Coagulation.~   "
142354|NCT01703988|"~     This study will test the safety, tolerability, and pharmacokinetics of escalating doses of~     nusinersen (ISIS 396443) administered into the spinal fluid either two or three times over~     the duration of the trial, in participants with spinal muscular atrophy (SMA).~      Four dose levels will be evaluated sequentially. Each dose level will be studied in a cohort~     of approximately 8 participants, where all participants will receive active drug.~   "
142355|NCT01703975|"~     Virtual Reality (VR) simulation has enabled high-quality, safe and efficient training of~     medical health care providers. However, training costs are considerable and may be optimized~     using interventions to improve learning. The aim of this study is to compare the effects of~     training in pairs versus training alone on an VR ultrasound simulator.~      Methods: 30 medical students in their final year are randomized to either training in pairs~     or training alone. All participants are trained for two hours. Subsequently, all students are~     assessed on ultrasound performance on real patients in an ambulatory setting. Performance is~     assessed using a rating scale that has been validated in a previous study by two blinded~     assessors.~   "
142356|NCT01703962|"~     The recurrent mutation IDH1Arg132His leads to the cellular accumulation of~     D-2-hydroxyglutarate (2-HG), thus representing a diagnostic marker (this change is almost~     specific for gliomas) and prognostic (mutated gliomas have longer survival) of interest.~      The main objective is to identify the patients with IDH1 mutated glioma by three~     complementary approaches -genetic (identification of IDH1 mutation in plasmatic DNA),~     biochemical (2-HG dosage in the urine of patients) and radiological (2-HG~   "
142362|NCT01703884|"~     The program's overall objective is to assess the impact of a package of interventions aimed~     at reducing malaria-related mortality and morbidity in pregnant women and newborns by~     ensuring access to a package of interventions designed to optimise the detection and~     treatment of malaria during pregnancy as well as improving the early detection and treatment~     of malaria during the third trimester.~   "
142363|NCT01703871|"~     Office Hysteroscopy is associated with a level of anxiety that could condition tolerability~     of the procedure by the patient.~      The aim of this study is to evaluate the impact of music on anxiety state, expected and~     received pain by patients during office hysteroscopy.~   "
142364|NCT01703858|"~     The objective of the trial is to investigate the relative bioavailability, influence of~     pantoprazole coadministration and food effect of different oral formulations of BI 113608 in~     healthy male subjects~   "
142365|NCT01703845|"~     The primary objective of this study is to assess pharmacokinetics of tiotropium + olodaterol~     fixed-dose combination (2.5 µg/ 5 µg, 5 µg/ 5 µg) delivered by the RESPIMAT inhaler after 3~     weeks once daily treatment in Japanese patients with COPD.~   "
142366|NCT01703832|"~     The purpose of this study is to explore the efficacy of acutely dosed Neurexan using an~     experimental stress test called the Trier Social Stress Test~   "
142367|NCT01703819|"~     The purpose of this study is to evaluate the efficacy of acutely dosed Neurexan using an~     experimental stress test called the Trier Social Stress Test~   "
142368|NCT01703806|"~     The timing of surgical intervention in asymptomatic patients with severe degenerative mitral~     regurgitation (MR) remains controversial. The benefit of early surgery has been suggested in~     prospective, observational studies, whereas a watchful waiting strategy seemed to be safe and~     effective in the other prospective study. The consensus guidelines for the performance of~     early surgery in asymptomatic patients with severe MR are different, reflecting controversy.~     Clinical outcome in asymptomatic patients with MR is poorly defined and it is important to~     identify high-risk patients in whom early surgery may be warranted. Thus, the investigators~     try to compare long-term outcomes of early surgery with those of a conventional-treatment~     strategy in a large prospective cohort of asymptomatic patients with severe degenerative MR~     using a propensity analysis, and to identify high-risk subgroups to whom early surgery is~     more beneficial.~   "
142369|NCT01703793|"~     The purpose of this study is to determine if two test products are safe and effective in the~     treatment of seborrheic dermatitis.~   "
142370|NCT01703780|"~     Hypertension is still one of the major preventable risk factor for cardiovascular as well as~     cerebrovascular diseases globally, including ischaemic heart disease, heart failure, and~     renal impairment. Despite knowledge on hypertension and the availability of effective~     antihypertensive medications have progressed dramatically in recent years, the rate of~     uncontrolled hypertension ( reached 90%) remains high in China[1]. Among those with~     uncontrolled hypertension，it has been reported that 8.9% in all individuals with~     hypertension, and 12.8% in the hypertensive drug-treated population[2] are attributed to~     resistant hypertension. Resistant hypertension has been defined by AHA as high blood pressure~     (BP) in spite of appropriate lifestyle interventions and treatment of three or more different~     types of antihypertensive drugs at optimal dose, including at least one diuretics[3,4] or~     achieving adequate BP control with optimal doses of 4 or more antihypertensive drugs.~      At present, not many specifically designed prospective researches concerning resistant~     hypertension are available. The prevalence of resistant hypertension is not well established~     and most knowledge about resistant hypertension derives from cross-sectional analyses and~     clinical trials. The patients with resistant hypertension have been expected to have server~     target damage, and worse prognosis than those who are non-resistant, but not well established~     either in the literature[2].~      The purpose of this study is to determine the prevalence of resistant hypertension~     ascertained with systemic investigation and optimal treatment with antihypertensive drugs in~     community populations and clinic as well as the prognosis among patients with resistant~     hypertension compared with those who are non-resistant.~   "
142371|NCT01703767|"~     The purpose of this study is to investigate Gulf War 1 Veteran (GW1V) patient perceptions of,~     and satisfaction with, their VA primary care treatment, and physician effectiveness in~     delivering improved point of service, in the Primary Care Clinics at the Veterans~     Administration (VA) Salt Lake City Health Care System.~   "
142372|NCT01703754|"~     Phase II, randomized, safety and efficacy study in recurrent/metastatic breast cancer with~     accessible lesions.~      Primary End point is rate of Progression Free Survival (PFS) at the 16 week treatment time~     point. Hypothesis: Adenoviral vector (Ad-RTS-hIL-12) alone and in combination with~     chemotherapy (palifosfamide) is safe and efficacious.~   "
142373|NCT01703741|"~     This is a multicenter extension trial in adult hypogonadal males. The purpose of this study~     is to evaluate the safety of testosterone gel delivered using an applicator over an extended~     period of time.~   "
142374|NCT01703728|"~     Ovarian hyper stimulation syndrome (OHSS) is a potentially serious complication of ovarian~     stimulation in IVF (In Vitro Fertilisation). The main objective of this study is to describe~     the incidence of moderate or severe forms of OHSS in women between 18 and 36 years of age~     treated with HP-hMG.~   "
142375|NCT01703715|"~     Dehydration is recognised as a major issue in healthcare. Recovery after illness, extended~     length of stay, pressure sores and slow tissue recovery can all be impacted by dehydration.~     One of the biggest problems for many people with regard to getting a drink is easy,~     independent access - if they can't reach the jug/cup without a struggle then they often will~     go thirsty and potentially become dehydrated.~      The purpose of this study is to investigate the impact of dehydration on outcome in patients~     65 years and over. Furthermore we aim to assess the impact of providing easy, 24 hour,~     independently accessible fluids on reducing dehydration as well as improving patient~     experience.~      We hypothesise that patients who are dehydration will take longer to recover from illness and~     stay in hospital for longer periods.~   "
142376|NCT01703702|"~     This study is designed to determine the effectiveness of florbetapir (18F) in changing~     patient management and to evaluate the association between scan status and cognitive decline.~   "
142853|NCT01697449|"~     This prospective observational study will evaluate the safety and efficacy of Avastin~     (bevacizumab) in patients with metastatic colorectal cancer. Data will be collected from~     patients receiving Avastin in combination with chemotherapy according to registered~     indication in routine clinical practice.~   "
142377|NCT01703689|"~     Introduction: Efficacy of audit and feedback interventions on nursing home (NH)quality~     indicators is not well-established.~      The main objective: The main purpose of the IQUARE study was to examine the impact of two~     types of audit and feedback interventions on NH quality indicators and on residents~     dependence levels in a 18-month follow-up.~      Study hypothesis: We hypothesised that audit and feedback associated to educational and~     professional supportive interventions are more efficacy in improving NH quality indicators~     than audit and feedback only.~      Secondary objectives: Investigate the impact of the interventions on~        1. Residents:~             -  Functional decline rate~             -  Drug prescriptions (quantity and quality)~             -  Prevalence of adverse health outcomes (e.g., falls)~        2. NHs:~             -  Planning and implementation of therapeutic measures~   "
142378|NCT01703676|"~     This study will elucidate how the parental origin of the X-chromosome influences health~     status as well as metabolic fate in Klinefelter patients. Epigenetics and~     transcriptome-research will be directly linked to the metabolic and inflammatory pattern of~     actual patients to improve care for them. The Klinefelter Syndrome is one of the most common~     genetic disorders in men. The patients have one supernumerary X-chromosome, which is partly~     active and disturbs a normal male development. Testosterone deficiency in form of primary~     hypogonadism is a common feature in these men. Such a condition promotes clinically relevant~     metabolic patterns related to a pro-inflammatory status and diabetes mellitus type 2 (insulin~     resis-tance), cardiovascular disease as well as infertility. However, the variety of~     pathologies is pro-nounced between patients and low testosterone concentrations cannot fully~     explain the wide scope of pathologies in these men. Some patients become clinically obvious~     during puberty and adoles-cence, some in their thirties or later and all exhibit a huge~     variation in phenotype. Switching on and off of specific genes on the X-chromosome is~     differential, depending on the origin either from the maternal or paternal side. Hence, an~     influence on the clinical picture is hypothesised. Thus, key targets are clarification of the~     parental origin of the supernumerary X chromosome and elucidation of methylation and~     expression profile of pivotal X-chromosomal genes. These will be related to clinically~     relevant metabolic and inflammatory patterns as well as fertility to identify individual~     risks as well as treatment strategies for Klinefelter patients.~   "
142379|NCT01703663|"~     Specific aim: To test the effects of nasal expiratory positive airway pressure (EPAP) therapy~     on sleep apnea severity among patients with recent ischemic stroke.~      Hypothesis 1: Ischemic stroke patients with sleep apnea will have less severe sleep apnea, as~     measured by the apnea-hypopnea index (AHI), with nasal EPAP therapy compared with a control~     night.~      Hypothesis 2: Ischemic stroke patients will have higher mean levels of oxygen saturation with~     nasal EPAP therapy compared with a control night.~   "
142380|NCT01703650|"~     The purpose of this study is~        1. to determine whether the perfusion parameters in the normal pancreas and the pancreas~          cancer (adenocarcinoma or neuroendocrine tumor) are different on perfusion CT~        2. to determine whether initial perfusion parameters as well as perfusion parameter change~          in pancreas adenocarcinoma before and after chemotherapy are different between~          chemotherapy response group (CR, PR according to RECIST 1.1) and non response group (SD,~          PD according to RECIST 1.1).~   "
142381|NCT01703637|"~     The purpose of this study is to explore the differences in efficacy and safety of~     sitagliptin,vildagliptin and saxagliptin and to find which one is more better in treating~     type 2 diabetes mellitus.~   "
142382|NCT01703624|"~     This is an investigation of the beneficial effects, tolerability and safety of a range of~     single doses of orally inhaled glycopyrronium bromide (PSX1002GB pMDI) in male and female~     patients with moderate or severe chronic obstructive pulmonary disease (COPD). COPD is a long~     term and progressive disease of the lungs, generally caused by cigarette smoking, but other~     factors may be involved. Glycopyrronium bromide (GB) appears to be particularly useful in~     dilating the constricted airways of such patients, with a duration of action variously~     described as being between 12 and 24 hours.~      This study will investigate how well tolerated and safe this medication is at a range of~     doses. It will also help in the selection of a suitable dose for larger and repeat dose~     studies, based on measures of lung response. It will also help to determine how often the~     medication should be given; twice daily, or once daily.~      Up to 40 patients will be enrolled into the study, ranging in age from 40 to 75 years of age.~     Patients will be medically assessed before participation to ensure their suitability. The~     study will take place in one centre in the UK over five sessions; at each session one dose (2~     puffs) of GB or one dose (2 puffs) of placebo will be administered from a simple inhaler~     device. Neither staff nor patients will know which dose, or if placebo, is being taken. Lung~     function will be measured for up to 26 hours after the administration of each dose using~     standard spirometry equipment. Blood samples will be taken over a 24-hour period to check the~     blood levels of GB. There will be a period of about a week between each dosing session.~     Patients will be medically reviewed after the study to confirm that no untoward effects are~     present.~   "
142383|NCT01703611|"~     A clinical trial to compare the patient outcomes from usual nutrition therapy by dietitians~     in India to patient outcomes from guideline-based Medical Nutrition Therapy (MNT).~   "
142384|NCT01703598|"~     The purpose of this study is to determine whether performing deep brain stimulation surgery~     for Parkinson's disease using intraoperative imaging and frameless stereotaxis is noninferior~     to using frame-based stereotaxy and microelectrode recording.~   "
142385|NCT01703585|"~     This is a feasibility study to look for genetic alterations in tissue and blood samples that~     may be useful in determining what treatments may be useful in the patient's cancer care.~   "
142386|NCT01703572|"~     This is an open-label Phase 1a dose escalation study of single-agent OMP-52M51 in subjects~     with relapsed or refractory lymphoid malignancies. Study includes a dose escalation phase and~     expansion phase. Subjects will be assessed for safety, immunogenicity, pharmacokinetics,~     biomarkers, and efficacy.~   "
142387|NCT01703559|"~     Night vision complaints such as glare, starburst and halo are often a result of peripheral~     corneal aberrations that cause light scatter when the pupil dilates in mesopic or scotopic~     conditions. Modest reductions in pupil size achieved pharmacologically may reduce the light~     scatter in dim light situations.~   "
142388|NCT01703546|"~     The purpose of this research study is to evaluate whether combining laparoscopic adjustable~     gastric band (AKA: lap-band surgery, LAGB) and laparoscopic gastric plication (making tucks~     in the large curve of the stomach with stitches) to lap-band surgery alone will result in a~     greater loss of excess weight over time. We anticipate that the average percent of excess~     body weight loss for study subjects will exceed 29% at 12 months.~   "
142389|NCT01703533|"~     The purpose of this study is to determine whether NNZ-2566 is safe and well tolerated in the~     treatment of Rett Syndrome in adolescent and adult females.~   "
142390|NCT01703520|"~     The objective of this study is to investigate the potential association between finasteride~     (MK-0906) exposure and the development of breast cancer in men residing in Denmark, Sweden,~     Finland, and Norway from data in national registries. The primary hypothesis of this study is~     that the previously reported increased incidence of male breast cancer among finasteride~     users is explained by confounding factors.~   "
142391|NCT01703507|"~     This phase I trial studies the side effects and best dose of ipilimumab when given together~     with whole brain radiation therapy or stereotactic radiosurgery in treating patients with~     melanoma with brain metastases. Monoclonal antibodies, such as ipilimumab, can block tumor~     growth in different ways. Some block the ability of the tumor to grow and spread. Others find~     Tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy,~     such uses high-energy x-rays and other types of radiation to kill tumor cells. Giving~     radiation therapy in different ways may kill more tumor cells. Giving ipilimumab together~     with whole-brain radiation therapy or stereotactic radiosurgery may kill more tumor cells.~   "
142392|NCT01703494|"~     There has been an alarming increase in the incidence and severity of Clostridium difficile~     infection (CDI) in North America over the past decade. Relapsing infection is a common~     problem in patients treated for CDI, often requiring prolonged and expensive courses of oral~     vancomycin with limited alternative treatment options. This study will determine if fecal~     microbiota transplantation, which involves administering fecal flora from a healthy stool~     donor to a patient with relapsing CDI, is an effective and safe treatment.~   "
142393|NCT01703481|"~     The purpose of this study is to evaluate the safety, pharmacokinetics (study of what the body~     does to a drug), and pharmacodynamics (study of what a drug does to the body) of~     JNJ-42756493, a pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor, in~     adult participants with advanced or refractory solid tumors or lymphoma.~   "
142394|NCT01703468|"~     The objective of this study was to prove the bioequivalence of Roxane Laboratories'~     Oxcarbazepine Suspension 600 mg under fed conditions~   "
142395|NCT01703455|"~     This is a single agent, prospective, open-label, monocenter, phase II trial of sorafenib in~     patients with recurrent and/or metastatic salivary gland carcinoma. This trial will be~     conducted with the primary aim to determine the response rate (CR+PR) according to the RECIST~     criteria. Response rate according to CHOI criteria, correlation between CHOI criteria and~     outcome, disease Control Rate (DCR) and acute toxicity will be evaluated as secondary~     objectives.~   "
142396|NCT01703442|"~     A single-center prospective observational study. This study examines urine flow and~     haemodynamic parameters during abdominal surgery and analyses the association to~     postoperative renal function and markers and to postoperative clinical outcome.~      Primary hypothesis:~      • Within a goal-directed haemodynamic protocol during gynecologic cancer surgery there are~     phases of temporary anuria.~      Secondary hypothesis:~        -  Perioperative anuric phases are directly associated to the postoperative increase of~          NGAL (neutrophil gelatinase-associated lipocalin) and creatinine~        -  Perioperative renal dysfunction is directly associated to postoperative complications~          and functional recovery of patients~        -  A response of urine flow to a standardized postoperative diuretic bolus can identify~          patients who benefit from a pharmaceutical fluid mobilization~        -  Within a goal-directed haemodynamic protocol during gynaecologic cancer surgery, the~          methods for the measurement of stroke volume of the heart differ~   "
142397|NCT01703429|"~     This is a prospective, observational study designed to describe disease progression, symptom~     change, quality of life, diet and lifestyle habits, and frequency of adverse events among~     patients with multiple sclerosis (MS) who use complementary and alternative medicine (CAM).~     In addition to describing the patterns of CAM use, this study will also identify and describe~     the positive deviants, those individuals with the highest quality of life and least amount of~     disease activity. Positive deviants will be compared to controls in order to describe~     medication, diet, and lifestyle patterns associated with a lack of MS disease progression and~     high quality of life.~   "
142398|NCT01703416|"~     This is a multi-center, prospective, non-interventional study that aims to evaluate in daily~     clinical practice the possible correlation between patient perception of the ability to~     perform morning activities and the physician's assessment during a regular physical exam in~     patients with Chronic Obstructive Pulmonary Disease (COPD), group C and D.~   "
142399|NCT01703403|"~     Low back pain is a common health issue in elderly population. According to the statistics,~     more than 80% of Taiwanese suffer low back pain in the life. The cause of low back pain~     includes lumbar spondylosis, osteoporosis, compression fracture, muscle strain,~     spondylolisthesis…etc. In addition to drugs and surgery, physical therapy is an alternative~     choice for conservative treatment. Therefore, in this study, the investigators propose to~     analyze the physical examination, diagnostic methods, X ray, physical therapy records,~     physical therapy methods and clinical outcomes in patients with the diagnosis including~     lumbar spondylosis, low back pain, osteoporosis, compression fracture, back pain treated at~     National Taiwan University Hospital and received rehabilitation at the Physical Therapy~     Center in recent ten years.~   "
142407|NCT01703299|"~     The use of carbapenems, very broad spectrum antibiotics of last resort, is becoming more~     common due to the increased prevalence in the hospital and community of extended spectrum~     β-lactamase (ESBL) producing gram-negative bacilli (GNB), including CTX-M type, which are~     resistant to all other β-lactam antibiotics. Meanwhile, it creates a selective pressure~     towards emergence of strains which are also resistant to carbapenems, placing patients in a~     catastrophic situation of therapeutic dead-end. A better understanding of the mechanisms of~     emergence of BGN resistant to carbapenems is necessary to optimize their use and undertake~     preventive measures to preserve their effectiveness. The aim of the study is to evaluate and~     describe the emergence of carbapenem-induced resistant GNB in patient intestinal microflora.~   "
142400|NCT01703390|"~     This pilot study is being mounted to assess whether treatment assignment by ERCC-1 gene~     expression status suggests better clinical results from historical experience in metastatic~     colorectal cancer (mCRC). In wild type KRAS mCRC patients treated with either FOLFOX or~     FOLFIRI in combination with cetuximab the median response rate is approximately 60-65%.~     Biomarker directed treatment in this study may demonstrate that patients with low ERCC-1~     treated with FOLFOX and cetuximab, and those with high ERCC-1 treated with FOLFIRI and~     cetuximab, will improve response rate to 70-75%. KRAS wild type patients will be treated with~     6 cycles of one of the following regimens chosen for optimization based on patient~     characteristics (primary treatment phase). Patients with ERCC-1 < 1.7 relative gene~     expression of ERCC-1 over ß-actin (ERCC-1 low) will be assigned to treatment with mFOLFOX6 in~     combination with Cetuximab. Patients with ERCC-1 gene expression > 1.7 relative gene~     expression of ERCC-1 over over ß-actin (ERCC-1 high) will be assigned to treatment with~     FOLFIRI in combination with Cetuximab.~   "
142401|NCT01703377|"~     A major advantage of understanding a neural control scheme is able to simultaneously perform~     multiple tasks based on the Uncontrolled Manifold (UCM) hypothesis by taking advantage of~     motor redundancy. The present study aims to investigate this hypothesis further by examining~     the effect of artificially eliminating knee and lumbar-thoracic joint motions on postural~     control when the arms performing targeting task simultaneously in standing. Subjects (Younger~     group: 20~35 years old; Elder group: 60~85 years old) will execute a targeting task with and~     without an additional ball-balancing task in standing with free joint motions and with~     restricted joint motions. The investigators expect to recruit 50 subjects for each group.~     Analyses of joint configuration variance on the stability of the center of mass (COM)~     position and the hand path will be performed using the UCM method of variance analysis. This~     method partitions joint configuration variance into one component consistent with the use of~     motor abundance and a component that leads to COM position or hand path variability.~     Furthermore, the differences between the younger group and the elder group will be evaluated.~   "
142402|NCT01703364|"~     This is a trial in patients with previously untreated CLL. Eligible patients will receive~     Lenalidomide with a backbone of Fludarabine and Rituximab for 6 therapy cycles. Lenalidomide~     will be increased by dose steps of 5 mg every cycle in the absence of limiting toxicity. If~     limiting toxicity ensues the patients will be treated with last tolerable dose for the~     remainder of the 6 treatment cycles.~      The first 5 patients will start with dose level 5 mg Lenalidomide and further escalating~     dose. After the fifth patient is included in the study, enrolment will be interrupted until~     this patient has finished his first treatment cycle. A safety board will evaluate the~     toxicities of the first 5 patients. If there are more than 2 patients experiencing a dose~     limiting toxicity (DLT) in the first treatment cycle, the starting dose will not be escalated~     and further 5 patients will be enrolled with a starting dose of 5 mg Lenalidomide. If only 2~     or less patients experience a DLT in the first treatment cycle, the next 5 patients will~     start the treatment with 10 mg Lenalidomide.~      The rational for the higher starting doses stems from the lack of tumor lysis or tumor flare~     toxicity in this combination on the one hand and from the observation that the very slow~     escalation from 2,5 mg on led to a lack of efficacy in monotherapy trials due to early~     progression in a relevant number of cases. The increase of the Lenalidomide dosage should~     result in an increased efficacy especially at the beginning and a higher cumulative dose of~     Lenalidomide.~      The identification of patients intolerant to Lenalidomide by immunophenotyping of the T cells~     for validation is also part of this trial, because intolerance seems to be not dose dependent~     but may be caused by T cell activation. Therefore, early identification of patients~     intolerant to this form of modern immunochemotherapy and establishing efficient Lenalidomide~     based combination therapy is an important part of improvement of current CLL treatment.~   "
142403|NCT01703351|"~     Since mid-2000, thoracoscopic lobectomy has been replaced with conventional open lobectomy~     and it has reduced the operative morbidities and mortalities. However, thoracoscopic~     lobectomy also results in operative acute pain and the incidence of chronic pain after~     thoracoscopic lobectomy has been reported as up to 50%. Penetration of chest wall by trocar,~     torque at trocar and working window by operator, and compression of intercostal nerves have~     been suggested as a cause of pain after thoracoscopic lobectomy. The intravenous~     patient-controlled analgesia (IV PCA) that usually have used to control the operative pain,~     sometimes cause the side effects such as sedation, nausea and vomiting due to its systemic~     delivery of analgesics. Because of these side effects, IV PCA has to be discontinues and the~     effective dose of analgesics could not deliver to patients. In contrast to IV PCA, continuous~     paravertebral infusion of local anesthetics thorough catheter below the parietal pleura might~     reduce the side effects of IV PCA and control the operative pain effectively. In this study,~     we investigate the effectiveness of continuous paravertebral infusion of local anesthetics~     thorough catheter below the parietal pleura for 60 hours after operation competed to IV PCA.~   "
142404|NCT01703338|"~     Lumbar fusion has been widely used for spinal disorders when conservative treatment has~     failed. However, a number of studies have reported that the rate of re-operation is high for~     lumbar fusion surgery. Swelling, atrophy or fat infiltration of the paraspinal muscles at the~     surgery site can cause weakness and pain. After fusion, the range of motion is constrained at~     the fused spine and might facilitate compensative movement of the adjacent levels and~     increase degeneration rate of the spine.~      Evidence has shown that core muscles play an important role to stabilize and support the~     spine. Whether core stability exercise can enhance spinal stability after lumbar fusion~     surgery remains unclear. Therefore, the overall goal of this proposed research is to~     investigate how core muscles affect outcomes after lumbar spinal fusion. The investigators~     will explore this issue hierarchically and systematically in 3-year duration.~   "
142405|NCT01703325|"~     Psoriatic nails can significantly affect a quality of life of patients. Psoriasis affects~     both nail matrix and nail bed. Pitting, leukonychia and red spots in lunula indicate a defect~     in the nail matrix. Psoriasis can change the nail bed as the results in onycholysis,~     discoloration, splinter hemorrhage and subungual hyperkeratosis. The main treatment of~     psoriatic nails is using topical high- potent steroids however topical steroids are limited~     their ability to penetrate deep nail matrix or nail bed which are the main pathology. Use of~     such a treatment can lead to skin atrophy and report in the case of Disappearing digits.~     Previous studies of steroid injection in the treatment of psoriatic nails show satisfactory~     results without any serious permanent adverse effects. At present, there is no comparison~     study between intralesional steroid and ultrapotent topical steroid for the treatment of~     psoriatic nails.~      The purpose of the study is to evaluate the efficacy and safety of intralesional~     triamcinolone comparing to 0.05% clobetasol ointment in the treatment of psoriatic nails.~   "
142406|NCT01703312|"~     This study will evaluate the efficacy of QGE031 compared to omalizumab in patients with~     allergic asthma. Each treatment's effect in changing the concentration of inhaled allergen~     that is required to elicit a 15% fall in the forced expiratory volume in one second (FEV1) at~     12 weeks compared to baseline will be evaluated.~   "
142408|NCT01703286|"~     The general aim of the present study is to investigate the impact of 4 weeks treatment with~     linagliptin (5 mg) on endothelial function in patients with type 2 diabetes mellitus. In the~     current trial this effect of linagliptin treatment on endothelial function will be compared~     against both the sulfonylurea glimepiride and against placebo, which has not been tested in a~     trial before; as also is the case for other DPP-4 inhibitors.~      Besides placebo, glimepiride was chosen as a comparator, as it is one compound of the second~     most used oral antidiabetic drug class.~   "
142409|NCT01703273|"~     While adolescents with obesity and extreme obesity are at increased risk for health~     complications, especially adolescents with extreme obesity rarely seek medical care, and~     sustained weigh loss is hardly ever achieved. One of the underlying reasons might be the lack~     of adequate treatment options.~      In this multicenter study, we aim to test a new, low key group intervention focusing on~     improving compliance and psychosocial functioning. The study is a subproject of the Medical~     and psychosocial implications of adolescent extreme obesity - acceptance and effects of~     structured care, short: Youth with Extreme obesity Study (YES), which aims at improving the~     medical care and social support structures for youth with obesity and extreme obesity in~     Germany.~      Obese youth and young adults (BMI ≥ 30kg/m2) between the ages of 14 and 24.9 years (initially~     up to 21 years) are eligible to participate. Participants will be asked to complete a series~     of questionnaires on their general health, psychosocial situation and wellbeing, and will be~     offered a thorough medical evaluation. Individuals who complete the baseline evaluations will~     be invited to participate in 6 group sessions over a 3 months period. Group assignment to the~     psycho-social intervention vs. routine care group will be at random, like throwing a dice.~     After 6 months, participants will complete further questionnaires to evaluate the effects of~     the interventions on quality of life and psycho-social functionning.~      The study will show the acceptance and effectiveness of a new intervention focusing on~     improving compliance and psychosocial functioning in adolescents with extreme obesity, and~     thereby inform the development of new treatment and support options for these adolescents. If~     interested, participants are invited to participate in additional components of YES, and to~     receive medical care and psycho-social support.~   "
142410|NCT01703260|"~     The purpose of this study is to evaluate the effect of roflumilast and pioglitazone therapy~     on serum transaminase (ALT) levels in adults with Nonalcoholic SteatoHepatitis.~   "
142411|NCT01703247|"~     The investigators have conducted a prospective, double-blind, randomized study to assess the~     comparative safety and efficacy of two different ablation strategies, PVI plus linear lesions~     (LL) versus PVI plus GP ablation, in patients with persistent or longstanding persistent AF.~     Results were assessed after follow-up of at least 3 years with the use of an implanted~     monitoring device (IMD).~   "
142412|NCT01703234|"~     There is no data about the effects of Renin angiotensin system blockage (RAS) on FGF23 and~     ADMA levels in diabetic patients with proteinuria. The aim of this study was to find out~     whether the beneficial effects of RAS blockage in diabetic proteinuria has any relation with~     the alteration of ADMA and FGF-23 levels. We searched for the effects of ACE inhibitor~     ramipril on the clinical and laboratory parameters of diabetic patients with proteinuria.~   "
142413|NCT01703221|"~     The purpose of this study is to assess the efficacy of omarigliptin 25 mg weekly (as~     monotherapy) compared with sitagliptin 50 mg daily and placebo, and the long term safety (up~     to 52 weeks) of omarigliptin 25 mg weekly. The primary hypotheses are that after 24 weeks: 1)~     Omarigliptin 25 mg weekly provides a greater reduction from baseline in glycosylated~     hemoglobin (HbA1c) compared with placebo, and 2) The mean change from baseline in HbA1c in~     participants treated with omarigliptin 25 mg weekly is non-inferior compared with that in~     participants treated with sitagliptin 50 mg daily.~   "
142414|NCT01703208|"~     The purpose of this study is to evaluate the cardiovascular (CV) safety profile of~     omarigliptin in participants with type 2 diabetes mellitus (T2DM). The primary hypothesis is~     that treatment with omarigliptin 25 mg once weekly is non-inferior to treatment with placebo~     and active comparators across the omarigliptin program with regard to the risk of developing~     a confirmed event in the primary CV composite endpoint.~   "
142415|NCT01703195|"~     The goal of this clinical research study is to learn if a type of MRI scan called diffusion~     weighted imaging (DWI) is accurate in checking the status of tumors. Researchers also want to~     learn if DWI can predict how tumors will respond to radiation therapy.~   "
142416|NCT01703182|"~     TCOM is a multicentre prospective cohort study in patients undergoing lower limb amputations.~     Patients will provide oxygen and carbon dioxide measurements in the lower limb for 20 to 30~     minutes before their surgery and will be followed up until 6 months after their surgery. The~     purpose of the TCOM study is to determine the ability of oxygen and carbon dioxide~     measurements in the legs of patients undergoing lower limb amputation to predict wound~     healing complications and to determine an optimum cutoff value for both oxygen and carbon~     dioxide levels beyond which healing complications are likely to occur and a closer amputation~     level is indicated.~   "
142417|NCT01703169|"~     The investigators hypothesis is that eltrombopag given to patients with moderate to very~     severe aplastic anemia will result in an increase in platelet counts. The investigators~     hypothesize that in patients with moderate to very severe aplastic anemia, treatment with~     eltrombopag will lead to fewer platelet transfusions, red blood cell transfusions, and fewer~     bleeding events. The investigators hypothesize that in patients with moderate to very severe~     aplastic anemia, eltrombopag will have an acceptable toxicity rate <3%, at doses that result~     in increased platelet counts. Finally the investigators hypothesize that plasma eltrombopag~     levels in peripheral blood will correlate with improved platelet counts.~   "
142418|NCT01703156|"~     A large number of patients are diagnosed with low risk ACS, and these individuals are at~     significant cardiovascular risk. Though guidelines recommend stress testing to manage low~     risk ACS patients, evidence supporting this recommendation is not based on trials examining~     this population. A well-designed, randomized trial is warranted to determine if stress~     testing is useful in managing low risk ACS. If medical therapy alone is equivalent as the~     investigators hypothesize, healthcare expenditures could be reduced and patients may not be~     exposed to the harms associated with more invasive cardiac testing such as coronary~     angiography.~   "
142419|NCT01703143|"~     To investigate whether MR-guided laser induced thermal therapy in patients diagnosed with~     focal lesional epilepsy using the Visualase Thermal Therapy System is both a feasible and~     safe minimally invasive technique for control of seizures in such patients.~   "
142444|NCT01702818|"~     Women with Hypoactive sexual desire disorder (HSDD) have all measures of testosterone~     activity comparable to controls but lower levels of dehydroepiandrosterone (DHEA). Although~     DHEA is a precursor of testosterone it has other actions including involvement in the stress~     system. It is also linked to mood. This study focuses on measures of childhood stress,~     current mood and salivary and nail stress hormones, in women with and without HSDD. We~     hypothesize that low levels of DHEA reflect dysfunction of the neuroendocrine stress response~     system involving the brain, pituitary and adrenal glands where DHEA is produced.~   "
142420|NCT01703130|"~     Interscalene block (ISB) consistently demonstrates superior pain relief after shoulder~     surgery. However, patients can experience complications such as blurred vision, hoarseness~     and shortness of breath with the standard volumes of local anesthetic used in contemporary~     practice. Patients with respiratory diseases are precluded because of the potential effects~     on respiration. However, they are then exposed to the risks of general anesthesia and opioid~     medications which can also have detrimental effects on respiration. Ultrasound guided ISB can~     reduce the local anesthetic volume required to produce anesthesia for shoulder surgery; this~     may reduce the complications from ISB to allow patients previously unable to benefit to have~     this technique, such as patients with obesity and respiratory disease. In order to do so the~     investigators will use an up-down methodology to find the minimum volume of local anesthetic~     to provide sufficient anesthesia for shoulder surgery.~   "
142421|NCT01703117|"~     Cognitive aging is a major source of disability in an increasingly aging population. The~     paucity of effective treatments for cognitive aging disorders, and most importantly in~     Alzheimer's disease instigates a need for further research into novel therapeutic~     possibilities. Alzheimer's disease is the most common neurodegenerative disorder and its~     prevalence steeply increases. Glutamate-mediated excitotoxicity in neuropsychiatric disorders~     and in particular in Alzheimer's disease has been shown to cause significant cerebral damage.~     Early effective therapeutic intervention in Alzheimer's disease is critical in order to~     prevent or at least retard neuropathological progression that will lead to widespread~     irreversible neuronal loss and significant cognitive dysfunction. Riluzole, a glutamate~     modulator agent that is a proven safe medication and has not yet been used in cognitive aging~     disorders, will be tested in mild Alzheimer's disease patients. Cognitive functional changes~     along with two established in vivo biomarkers, namely, Magnetic Resonance Spectroscopy (MRS)~     and Fluorodeoxyglucose (18F) positron emission tomography (FDG-PET) will be evaluated.~   "
142422|NCT01703104|"~     The primary objective is to determine if there is a significant increase in the haematocrit~     value of patients on Jobelyn and standard therapy compared to those on standard therapy~     alone.~   "
142423|NCT01703091|"~     The purpose of this study is to evaluate the effects of ramucirumab in combination with~     docetaxel in participants with Stage IV non-small cell lung cancer who have had disease~     progression during or after one prior first-line platinum-based chemotherapy with or without~     maintenance therapy for advanced/metastatic disease.~   "
142424|NCT01703078|"~     The purpose of this study is to determine if the new ingenol derivative gels are as safe as~     and as well tolerated as ingenol mebutate gel when applied to AK lesions on the forearm for~     two consecutive days.~   "
142425|NCT01703065|"~     This pilot clinical trial studies cabozantinib in treating men with castration-resistant~     prostate cancer. Cabozantinib may stop the growth of tumor cells by blocking some of the~     enzymes needed for cell growth.~   "
142426|NCT01703052|"~     This study is designed to investigate the safety, tolerability and pharmacokinetics of~     inhaled CHF 6001 after single and multiple doses in healthy volunteers.~   "
142427|NCT01703039|"~     The investigators are doing a research study to find out if riluzole, when taken along with a~     standard antidepressant (sertraline) can help people with major depression.~      This research study will compare riluzole + sertraline to placebo + sertraline. The~     investigators hypothesize that adding riluzole will lead to a better antidepressant response,~     in less time, then sertraline alone.~   "
142428|NCT01703026|"~     Contrast enhanced EUS with the sonographic contrast agent DEFINITY™ has the potential to~     detect pancreatic cancer at an earlier stage, to improve current method of T staging and~     assessment of surgical resectability and also to distinguish between benign and malignant~     pancreatic masses. All these will translate into better clinical outcome, and also avoid~     unnecessary surgery in situations of unresectable cancers.~   "
142429|NCT01703013|"~     The pathophysiology of the adrenal insufficiency of patients with critical diseases remains~     unclear. In a prior exploratory study investigating patients with exacerbation of chronic~     obstructive pulmonary disease (COPD), the investigators demonstrated a highly significant~     correlation between the expression level of Defensin-alpha 4 (DEFA4) mRNA in blood and the~     adrenal function assessed via low-dose ACTH tests. The aim of this prospective study is to~     demonstrate that DEFA4 measured both at the mRNA level (RT-PCR) and at the protein level~     (Western blot/Elisa) is a reliable biomarker for the prediction of adrenal insufficiency in~     inflammatory lung diseases (patients with COPD and pneumonia).~   "
142430|NCT01703000|"~     NG PROMUS: A Prospective, Multicenter Trial to Assess the NG PROMUS Everolimus-Eluting~     Platinum Chromium Coronary Stent System (NG PROMUS Stent System) for the Treatment of~     Atherosclerotic Lesion(s)~   "
142431|NCT01702987|"~     It is our primary hypothesis that statin drugs impair skeletal muscle mitochondrial function~     and that ubiquinol (the reduced active form of CoQ10) supplementation will block impairment~     of PCr recovery kinetics in patients using statins. The investigators propose a pilot study~     to extend our research to examine PCr recovery kinetics in 20 statin users randomized in a~     parallel arm study to either ubiquinol or placebo over 4 weeks.~   "
142432|NCT01702974|"~     The aim with this study is to provide immunotherapy with vitamin D and phenylbutyrate to~     treatment-naive HIV infected patients to induce important antimicrobial defence mechanisms~     and decreased inflammation.~   "
142433|NCT01702961|"~     High-dose chemotherapy followed by autologous (the patient's own) peripheral blood~     (circulating blood) stem cell (cells that divide to form white cells, red cells and cells~     that help clot) transplantation is a conventional treatment for patients with lymphoma~     (cancer of lymph glands) and Hodgkin's disease (cancer of lymph glands) after first relapse~     (recurrence of disease). For patients who did not have a complete response after traditional~     chemotherapy, the chance is high that the tumor will return even after high-dose~     chemotherapy. To improve the response and decrease the chance of relapse, doctors have used~     rituximab, an antibody that kills lymphoma cells, both before and after transplantation.~     These doctors have reported that more patients had control of the tumor for an extended~     period of time using rituximab with high-dose chemotherapy with autologous stem cell~     transplantation. How widely this is applicable is not known.~      The purpose of this clinical research trial is to confirm that there is a good control of~     tumor in patients with lymphoma or Hodgkin's disease treated with rituximab and conventional~     stem cell transplantation.~   "
142434|NCT01702948|"~     Background:~      - Nicotine addiction often makes it difficult to stop smoking. Researchers want to understand~     the areas of the brain that are important in nicotine addiction. They will use a type of~     brain stimulation called repetitive transcranial magnetic stimulation (rTMS) to look at part~     of the brain that may be involved in nicotine addiction. They will see how these areas affect~     brain function, thinking, and decision making. For this study, rTMS will first be tested on~     nonsmokers, then smokers will be recruited at a later time.~      Objectives:~      - To study areas of the brain involved in nicotine addiction.~      Eligibility:~      - Individuals at least 18 years of age who do not smoke.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          provide a urine sample.~        -  There will be four study sessions. The first session will involve a magnetic resonance~          imaging (MRI) scan. The other three visits will involve rTMS and MRI scans.~        -  The first MRI scan will take a baseline picture of the brain. Participants will also~          practice the tasks for the other three sessions in a mock scanner.~        -  At the next three visits, participants will have rTMS and MRI scans. Two visits will~          involve rTMS; the other visit will involve mock rTMS with no actual magnetic~          stimulation. During the MRI scans, participants will perform tasks that involve decision~          making.~   "
142435|NCT01702935|"~     Background:~      - Primary ovarian insufficiency (POI) is a condition that affects ovary function. It means~     that the ovaries are not able to function at a level appropriate for a woman's age.~     Previously, it was thought that women had only a fixed number of eggs that were lost each~     month until none were left at menopause. However, recently, stem cells have been found in the~     ovaries of adult women. These stem cells may be able to make new eggs. Studying these cells~     may help women with POI in the future. Researchers want to collect ovarian tissue from women~     with POI to investigate ovarian stem cells.~      Objectives:~      - To collect ovarian tissue from women with primary ovarian insufficiency.~      Eligibility:~      - Women between 18 and 50 years of age with primary ovarian insufficiency.~      Design:~        -  Participants will be screened with a physical exam and medical history. They will also~          have a full gynecological exam. They will provide blood and urine samples.~        -  Participants will donate ovarian tissue for study. It will be collected through~          outpatient surgery. The surgery will take either half of an ovary or a full ovary.~        -  Treatment will not be provided as part of this study.~   "
142436|NCT01702922|"~     Background:~      - Serious illnesses like cancer or Neurofibromatosis Type 1 (NF1), can cause high levels of~     stress in a family. When a child is diagnosed with cancer or NF1, parents face numerous~     stressors, each of which can strain relationships. Many parents struggle to effectively cope~     with the changes in parenting roles that often accompany treatment of childhood cancer or~     NF1. How parents cope with this stress can influence whether the relationship is strengthened~     or weakened. Stress levels can also affect the care of the child who has cancer or NF1.~     Researchers want to better understand the critical time points and events during the child s~     treatment when the relationship becomes most stressed and/or strengthened.~      Objectives:~      - To study how stress affects the relationship between parents who have a child with cancer~     or Neurofibromatosis Type 1 (NF1).~      Eligibility:~        -  Parents of a child (between 1 and 24 years of age) who has been diagnosed with cancer or~          NF1.~        -  Participants must have been in a partnership at the time the child was diagnosed with~          cancer or NF1. At least one of the parents must be a biological or legal parent of the~          child.~      Design:~        -  Participants will fill out a questionnaire either online or by paper and pencil. It will~          take about 20 minutes to complete. The questions ask about the experience of dealing~          with a child s cancer OR NF1 diagnosis and how it affects participants relationship with~          their spouse/partner.~        -  Some participants will also have an in-depth interview. It will last about an hour. It~          will ask further questions about the cancer OR NF1 diagnosis and treatment and its~          effect on the relationship.~        -  Treatment will not be provided as part of this study.~   "
142437|NCT01702909|"~     The purpose of this study is to determine whether Interleukin-2 at the dose and schedule used~     in this study will help increase tumor shrinkage.~   "
142438|NCT01702896|"~     To determine whether Interleukin-2 at the dose and schedule will help to increase tumor~     shrinkage~   "
142439|NCT01702883|"~     The purpose of this study is to evaluate whether participation in an Internet-based~     intervention helps improve medication use.~   "
142440|NCT01702870|"~     A prospective observational study to determine the effectiveness of magnetic resonance (MR)~     imaging in the diagnosis and monitoring of idiopathic myopathy in adult humans.~   "
142441|NCT01702857|"~     This is a first time in humans (FTiH) study designed to assess the experimental TDENV-PIV~     vaccine in a predominantly dengue-primed adult population. The study is designed to afford a~     first time in humans (FTiH) safety and immunogenicity assessment of three TDENV-PIV vaccine~     candidates, each formulated with a different adjuvant: either aluminum hydroxide, AS01E or~     AS03B (adjuvants used in GSK Biologicals' hepatitis B candidate vaccine, malaria candidate~     vaccine and pandemic flu vaccine, respectively). Each vaccine candidate will contain 1 µg of~     purified virus antigen per each of the four DENV types. Additionally, the study will evaluate~     an alum adjuvanted TDENV-PIV vaccine candidate containing 4 µg of purified virus antigen per~     each of the four DENV types. The control group will receive a saline placebo. All~     experimental vaccinations will be administered according to a 2-dose schedule, 28 days apart.~     There is a parallel FTiH study that is conducted in the United States in a dengue-naive~     population using the same investigational vaccines.~   "
142442|NCT01702844|"~     The purpose of this study is to evaluate the safety and efficacy of weekly nab-paclitaxel for~     a second-line treatment in elderly subjects, 70 years of age or greater, with non-small cell~     lung cancer (NSCLC)~   "
142443|NCT01702831|"~     A number of strategies have been proposed to improve the outcome of ASCT. The three main~     strategies are to incorporate novel agents into the induction regimen, using maintenance~     therapy following ASCT and the final strategy is to enhance conditioning regimens.~      Investigators would like to explore all these three strategies in this study: Investigators~     propose to take patients who have had standard novel agent (bortezomib) based induction~     regimens into this study and then use a dose-adjusted combination of busulfan and melphalan~     as conditioning regimen and finally Investigators would like to incorporate lenalidomide~     maintenance post ASCT until disease progression.~   "
142445|NCT01702805|"~     The objective of the TOP trial is to determine whether higher hemoglobin thresholds for~     transfusing ELBW infants resulting in higher hemoglobin levels lead to improvement in the~     primary outcome of survival and rates of neurodevelopmental impairment (NDI) at 22-26 months~     of age, using standardized assessments by Bayley.~   "
142446|NCT01702792|"~     This is a non-randomized, open-label study in patients with newly diagnosed glioblastoma to~     determine the ability to generate human hybridomas from lymph nodes draining an autologous~     tumor vaccine injection and demonstrate that the hybridomas secrete glioblastoma-specific~     antibodies.~   "
142447|NCT01702779|"~     This is a prospective, randomized clinical multicentric study in ICU (Intensive Care~     University)during weaning from mechanical ventilation.~   "
142448|NCT01702766|"~     Hypothesis: Use of Bifidobacterium animalis subsp. lactis can effectively prevent common~     nosocomial (gastrointestinal and respiratory) infections. Nosocomial infection will be~     defined as infections which develop more than 48 hours after admission and they are not~     present or incubating on admission~      This study is a prospective, randomized, double blind, placebo- controlled parallel study in~     children hospitalized at Children's hospital Zagreb.~      The study will investigate the effect of supplementation with the probiotic strain~     Bifidobacterium animalis subsp. lactis on the incidence and duration of gastrointestinal and~     respiratory infections.~      The test product is a sachet containing 1 gram of powder. The test product will contain~     minimum 1 billion CFU (colony forming units) probiotic per serving.~      The placebo product is an identical product except for the absence of probiotics.~      The study includes an intervention period lasting the length of the hospital stay.~      The study product will be consumed daily in the morning together with breakfast.~      The consumption of the study products will be taken under the surveillance of the physician.~      Data on infections will be diagnosed by a physician and recorded in a CRF. The incidence of~     infections will be analyzed based on the information recorded in the CRF.~   "
142449|NCT01702753|"~     Hypothesis: Use of Bifidobacterium animalis subsp. lactis can effectively prevent common~     infections (gastrointestinal and respiratory) in healthy children who attend day care centre~      This study is a prospective, randomized, double blind, placebo- controlled parallel study in~     healthy children attending day care centers.~      The study will investigate the effect of supplementation with the probiotic strain~     Bifidobacterium animalis subsp. lactis on the incidence and duration of gastrointestinal and~     respiratory infections and absence from day care due to infections.~      The test product is a sachet containing 1 gram of powder. The test product will contain~     minimum 1 billion CFU (colony forming units) of probiotic per serving. The placebo product is~     an identical product except for the absence of probiotics.~      The study includes 3 months (90 days) of intervention period. The study product will be~     consumed daily in the evening together with a meal.~      The consumption of the study products will be taken under the surveillance of the parents.~      During the entire intervention period the subjects are not allowed to consume any probiotic~     products other than the study products supplied to them by the study personnel.~      Data on infections will be recorded in a diary, filled in and administered by the parents and~     diary recorded by referring physician (on-call log).~      All infections are to be diagnosed by the local physician. The incidence of infections will~     be analyzed based on the information recorded in the diaries (parent's & physician's).~   "
142450|NCT01702740|"~     The main purpose of this study was to evaluate the safety and pharmacokinetics (PK, the~     action of a drug in the body over a period of time) of multiple intravenous (IV)~     administrations of CNTO 136 in patients with cutaneous lupus erythematosus (CLE) and systemic~     lupus erythematosus (SLE). The secondary goal of this study was to assess the~     pharmacodynamics (biochemical and physiological effects of a drug and the mechanisms of~     action), immune response, and clinical response.~   "
142451|NCT01702727|"~     The study aims to determine whether 30 minutes of treatment playing an interactive computer~     game weekly for 6 weeks, improves visual acuity. The game has been specially configured to~     ensure the amblyopic eye is preferentially stimulated and the patient wears shutter glasses~     which manipulate the image seen by each eye in order to provide more information to the~     amblyopic eye. Patients will be randomised to play the computer game using the I-BiTTM~     technology, play the computer game but without the I-BiTTM technology, or watch a DVD using~     the I-BiTTM technology.~   "
142452|NCT01702714|"~     This open-label, multicenter, non-randomized, dose-escalating phase Ib study with an~     expansion cohort will determine the recommended Phase II dose and schedule to investigate~     safety, tolerability, and activity of RO5083945 in combination with cisplatin and gemcitabine~     or carboplatin and paclitaxel in patients with advanced or recurrent non-small cell lung~     cancer of squamous histology who have not received prior chemotherapy for the metastatic~     disease. Cohorts of patients will receive escalating doses of RO5083945 in combination with~     up to 6 cycles of cisplatin and gemcitabine or carboplatin and paclitaxel. Anticipated time~     on study treatment is until disease progression or unacceptable toxicity occurs.~   "
142453|NCT01702701|"~     This study will compare response to treatment of Eosinophilic Esophagitis with montelukast vs~     standard therapy fluticasone. Investigators hypothesize that montelukast is equally effective~     in treating symptoms and histology of EoE when compared to fluticasone. The study will be~     conducted at multiple sites with Medical College of Wisconsin as the coordinating site. After~     identification and recruitment all patients will be randomized (provider blinded) to one of~     two medications: montelukast 10mg po qday vs fluticasone 440mcg po bid. Patients will also~     complete a pretreatment, 6 week therapy and 12 week therapy questionaire. They will then~     undergo a repeat endoscopy to evaluate endoscopic and histologic response.~   "
142468|NCT01702506|"~     Evaluation of the potential effect that the administration of food or antacid medication may~     have in the oral absorption of dacomitinib relative to the administration of dacomitinib in~     absence of food or antacid medication~   "
142505|NCT01702025|"~     In low oxygen environments, such as altitude, some adults may become ill and suffer from~     acute mountain sickness. Further, all adults will find that exercising becomes much more~     difficult when compared with exercise at lower altitudes (e.g. sea-level). The purpose of~     this investigation is to study the effects of two drugs that may help people adjust to~     high-altitude quickly, prevent them from becoming ill and improve their exercise performance.~     The drugs are Methazolamide and Aminophylline.~   "
142454|NCT01702688|"~     Thank you for your interest in our Blood Pressure Research Study. The American Heart~     Association is sponsoring us to investigate why patients develop high blood pressure,~     atherosclerosis (hardening of the arteries), and heart disease. There are two parts of our~     research program. The first part is a screening visit. At this visit you will be given a~     brief physical exam and will be asked questions concerning your medical history. During the~     same visit you will have your blood drawn for routine screening and genetic testing. You will~     also be asked to collect a urine sample for routine screening.~      If the doctor finds that you are a healthy candidate you will be invited to participate in~     the second part of the study. During Phase II, we will perform physiological tests after you~     are placed on a low salt diet and again after you are placed on a higher salt diet. If you~     are on blood pressure medication, it may be necessary to discontinue taking your present~     medication for up to three months before beginning the study. Patients discontinuing their~     current blood pressure medication may be placed on a different blood pressure medication~     during this 'washout' period if necessary to maintain blood pressure at pre-study levels.~      Once your blood pressure medications are discontinued, you will be closely monitored. If you~     do not own a home blood pressure monitor, we will provide one for you to use during the study~     so that you can keep a daily record of your blood pressure readings. We will ask you to call~     us every three days to report your blood pressure readings. After you have stopped taking~     your medication, dietitians at the hospital will make you low salt meals to eat at home for~     about seven days. On the last day of the low salt diet, you will be asked to begin a 24-hour~     urine collection that you will bring with you when you are admitted to the hospital that~     evening. That morning, you will be required to come to the Center for Clinical Investigations~     (CCI) at Brigham and Women's Hospital for a one-hour test to check if your body is in the~     correct salt balance.~      You will return that evening to the CCI where you will be admitted for your study that will~     occur the next morning. On the morning of your low salt study, we will collect some blood~     samples. We will also take ultrasound pictures of your heart to see how salt and hormones~     affect the way your heart and blood vessels functions. These tests will last approximately 5~     hours and you will be discharged around 2:00 PM. For the next 5-7 days, you will be placed on~     a liberal salt diet. During this diet period, you will eat all your own food, but we will~     give you some supplements to add to your meals. After 5-7 days on your liberal salt diet, on~     the morning of your second admission to the hospital, you will be asked to begin a final~     24-hour urine collection. That morning, you will again be required to come to the CCI for a~     blood test, and you will return later that evening to the inpatient CCI where you will be~     admitted for your final overnight study. The same study that was done for the low salt diet~     will be repeated for the liberal salt study. You will be discharged at around 2:00 p.m. These~     studies will help to determine if you are salt-sensitive. In addition, we hope to learn more~     about the hormones that regulate your blood pressure and the genes responsible for regulating~     those hormones.~      You will be placed back on your initial blood pressure medication (if you are on any) and~     returned to your regular physician for care. We can also provide clinically relevant~     information to you.~   "
142455|NCT01702675|"~     The purpose of this study is evaluate the safety and tolerability parameters regarding the~     new drug in healthy men and evaluate the pharmacokinetics parameters after one dose and~     multiple doses of the new drug.~   "
142456|NCT01702662|"~     Photo-bio-stimulation by Low Level Light therapy(LLLT) has demonstrated its clinical use in~     chemotherapy/radiotherapy oral mucositis.~      Unpublished study (Melzer, Ben-Yehuda et al. UEGW 2012) with the Photopill (LLLT) capsule~     treatment in mice showed a significant beneficial effect on the endoscopic severity of~     DSS-induced colitis in mice.~      Therefore a phase 1 trial is designed to assess the safety and feasibility of the Photopill~     treatment in healthy volunteers.~   "
142457|NCT01702649|"~     RPX2003 (biapenem) is being studied in combination with a beta-lactamase inhibitor to treat~     bacterial infections, including those due to multi-drug resistant bacteria.~   "
142458|NCT01702636|"~     The aim of the study is to test if intracerebral haemorrhage (ICH) patients who have contrast~     extravasation on computed tomography angiography, the spot sign, have lower rates of~     haematoma growth when treated with tranexamic acid within 4.5 hours of stroke onset, compared~     to placebo.~   "
142459|NCT01702623|"~     The objective of this study was to prove the bioequivalence of Roxane Laboratories'~     Oxcarbazepine Suspension 600 mg under fasted conditions.~   "
142460|NCT01702610|"~     Patients with GBM, who were deemed ineligible for any active protocols at our centre,~     received accelerated hypofractionation EBRT if 60Gy/20Fx using an IMRT technique with~     conventional dose of concomitant and adjuvant TMX as per the STUPP's TMZ schedule. Thirty~     five patients, 15 females and 20 males with a median age of 63 (range 31-78) were treated~     with a median KPS of 90 (range 50-100). Four patients had multicentric disease at~     presentation. Eight patients had biopsy only while the rest had a near total resection (n=14)~     and partial resection (n=13) with a median follow-up of 12.1 months, the median survival was~     14.4 months.~   "
142461|NCT01702597|"~     The aim of this bicentric, biphasic, randomized, controlled study is to compare of the~     current gold standard functional treatment to functional treatment plus WBV in patients with~     acute unilateral unstable inversion ankle sprains over a period of 12 months~   "
142462|NCT01702584|"~     Prospective registry study to evaluate safety and efficacy of stent assisted embolization of~     intracranial aneurysm.~   "
142463|NCT01702571|"~     This two-cohort, open-label, multicenter study will assess the safety, efficacy and~     tolerability of trastuzumab emtansine in participants with HER2-positive locally advanced~     breast cancer (LABC) or metastatic breast cancer (mBC) who have received prior anti-HER2 and~     chemotherapy-based treatment. Participants in Cohort 1 will be drawn from the general~     participant population; Cohort 2 will include only Asian participants.~   "
142464|NCT01702558|"~     This multicenter study will assess the maximum tolerated dose of capecitabine in combination~     with Kadcyla (trastuzumab emtansine) in participants with HER2-positive mBC or HER2-positive~     LA/mGC using a Phase I design, followed by a randomized, open-label Phase II study to explore~     the efficacy and safety of the combination of Kadcyla and capecitabine compared with Kadcyla~     alone in mBC. The anticipated time on study treatment is until disease progression,~     intolerable toxicity, or withdrawal of consent.~   "
142465|NCT01702545|"~     The current state of knowledge on the concentration of drugs and their metabolites in the~     individual human body is not satisfying concerning the question about behavior of drugs in~     the human body, taking into account individual patient factors such as age, weight and organ~     dysfunctions.~      This projects deals with the question of drug levels in the blood of hospitalized patients.~      The aim of this study is to extend the knowledge about the behavior of drugs in the human~     body significantly, for the safety and benefit of future patients. This also includes to~     establish a relationship between drug levels in patients and the desired and undesired~     effects of a drug.~      As a result, the future perspective is to find the optimal dose for the individual patient by~     measuring the blood concentration of a drug.~   "
142466|NCT01702532|"~     Nicotine mouth film is a new dosage form of nicotine replacement therapy. The purpose of this~     study is to investigate the craving relief efficacy of nicotine mouth film by comparing mint~     nicotine mouth film to nicotine lozenge in light smokers using the provoked craving model.~     The cues used to provoke a craving episode will be the sight and smell of a lit cigarette and~     the manipulations required to light a cigarette. The smokers will be denied access to~     cigarettes for 4 hours prior to the provoked craving session in order to precipitate nicotine~     withdrawal and an increase level of cigarette craving.~   "
142467|NCT01702519|"~     Bioequivalence study to confirm that a NTS with a polyisobutylene (PIB) adhesive from an~     alternative supplier delivers the same nicotine blood profile as that of the currently~     approved NTS with a polyisobutylene adhesive from the current supplier.~   "
142469|NCT01702493|"~     This is an open-label, randomized, controlled, single center study to assess the safety,~     variability in exposure, and relative bioavailability of new oral formulations of SRT2104.~     This is a two part study and each part consists of screening (within 21 days of the first~     scheduled dose of SRT2104), treatment period and follow-up visit (approximately 6 days after~     the last dose). Part 1: Subjects will receive all four fomulations of SRT2104 and their order~     of their doses will be randomized. Each subject will receive one formulation as a 500~     milligram (mg) dose (in the form of two 250 mg capsules or tablets) in each session given in~     the fasted state. Each dose will be separated by at least 6 days. Pharmacokinetic (PK)~     sampling will be done pre and post each scheduled dosing session. After all 4 dosing~     sessions, the safety and PK data will be reviewed to determine which, if any, formulation(s)~     will be carried forward into Part 2. The total duration will be approximately 7 weeks. Part~     2: Is further divided into Part 2A, 2B and 2C of the study and are optional. After the~     completion of Part 1, the sponsor will decide whether to proceed with any or all of Part 2,~     and whether the selected formulation(s) is to be administered in the fed or fasted state for~     Parts 2B and 2C. For all the sub parts of Part 2 the pre and post-dose PK samples will be~     obtained. Part 2A: A single-dose of the selected formulation(s) from Part 1 will be~     administered after a standard meal to assess the effect of food on the bioavailability of~     SRT2104 at the 500 mg dose. The total duration will be approximately 4 weeks. Part 2B: A~     single alternative dose (other than 500 mg, but not to exceed 2000 mg) of the selected~     formulation(s) from Part 1 will be administered to assess the safety and PK profile of this~     dose level. The total duration will be approximately 4 weeks. Part 2C: The selected~     formulation(s) from Part 1 will be administered at the 500 mg dose once daily for 7~     consecutive days, to assess the safety and tolerability and characterize the PK profile of~     repeat dosing. The total duration will be approximately 5 weeks.~   "
142470|NCT01702480|"~     This is a single centre, 2 part study in older subjects. Part 1 (Pharmacokinetic [PK]~     Assessment) is a double blind, randomized, placebo-controlled 4-period crossover study~     investigating the PK profile of four different doses of GSK2981710. Eight subjects will~     receive a single dose of GSK2981710 10 gram (g), 20 g, 30 g, 40 g or placebo in the morning~     and have PK assessments (every 0.5 hrs up to 8 hrs post-dose) throughout the day in each~     period. Each subject will complete a total of four dosing sessions and 4 days of PK~     assessments in 2 weeks. The Part 1 PK data will be used for dose selection and~     pharmacodynamic (PD) assessment period in Part 2. If the data from Part 1 is inconclusive, an~     additional 8 subjects may be recruited and Part 1 repeated (possibly dropping some doses) to~     increase confidence. A subject's total participation in Part 1 of the study will last a~     maximum of approximately 7 weeks including screening. Subjects who have completed Part 1 may~     be screened for eligibility and enrolled for Part 2.~      Part 2 (PD Assessment) is a double blind randomized, placebo-controlled 2-period crossover~     design with 14-day treatment periods investigating the efficacy (cognitive performance) and~     tolerability (gastrointestinal [GI] side effects) of single daily dose of GSK2981710 selected~     from Part 1. Part 2 of the study will include the Screening period, two Baseline assessments~     (6-8 days before each Treatment period) and two 14-day treatment periods separated by a~     minimum 7-day washout period and follow-up visit of 3 to 5 days. Approximately 50 to 80~     subjects will be randomized to either GSK2981710 or placebo. The PD assessments will be~     performed on 6 occasions for each subject: at 2 baselines (6 to 8 days before Day 1 of each~     treatment period), post-dose on the Day 1 of each treatment period to assess acute effects~     and on Day 15 of each treatment period (which is the day after the final dose) to assess~     chronic effects. A subject's total participation in Part 2 of the study will last~     approximately up to 12 weeks including screening.~   "
142471|NCT01702467|"~     The current study will examine the safety, tolerability, plasma pharmacokinetics (PK), and~     plasma pharmacodynamics (PD) of single-doses of GSK2647544.The study will be conducted as a~     randomized, single-blind, placebo controlled, 4-way crossover single oral ascending dose~     design in 2 independent cohorts, eight healthy male subjects in each of the cohorts. Each~     potential subject will undergo Screening visit, Treatment Phase and Follow-up visit.~   "
142472|NCT01702454|"~     The purpose of this study is to assess the safety and immunogenicity of GSK Biologicals'~     investigational vaccine GSK2321138A in children who previously participated in study 115345~     (FLU D-QIV-004 PRI) (NCT01439360).~   "
142473|NCT01702441|"~     The purpose of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and~     pilot efficacy of multiple ascending dose levels of AKB-9778 given as subcutaneous injections~     daily for 28 days in patients with diabetic macular edema (DME).~   "
142474|NCT01702428|"~     The purpose of this study is to evaluate consistency in terms of the immune response to three~     different lots of GSK Biologicals' trivalent MMR vaccine manufactured to target potencies,~     and compare its immunogenicity to Merck & Co., Inc.'s MMR vaccine, which is approved for use~     in the United States (US).~   "
142475|NCT01702415|"~     Null hypotheses: zoledronic acid does not improve bone density in cystic fibrosis.~      Low bone mineral density (osteoporosis) is prevalent in adults with cystic fibrosis (CF);~     they have an increased rate of bone fractures in comparison to the general population. CF~     patients start to lose bone density in adolescence/early adulthood due to an imbalance in~     bone breakdown and formation. Predicted survival for patients with CF has increased from 16~     years in 1970 to 36.5 years in 2009 which has resulted in an increase in comorbidities~     associated with increased longevity in CF e.g. decreased bone density. Oral and intravenous~     bisphophosphonates are known to increase bone density in CF; the current licensed oral~     preparations require daily or weekly dosing which are difficult to maintain. Zoledronate,~     which is licensed for use, is administered intravenously once a year which should be easier~     to administer. The current evidence relates to its use in other disease groups e.g.~     glucocorticoid induced osteoporosis and oncology. The purpose of this study is to ascertain~     its efficacy in cystic fibrosis.~   "
142476|NCT01702402|"~     The proposed operations research study is designed to evaluate a package of family planning~     services and related behavior change interventions aimed at addressing the unmet need for~     family planning in postpartum women, integrated with an ongoing maternal and newborn health~     program, and to assess the program's impact (1) on knowledge of healthy fertility practices,~     (2) on contraceptive use prevalence in women during the postpartum period, (3) on postpartum~     birth spacing, and (4) to examine the feasibility and sustainability of the proposed~     integrated service delivery approach. The study will have a quasi-experimental design, with~     evaluation primarily through household surveys in four intervention unions and four~     comparison unions (unions are lowest local government entities with an average population of~     about 20,000) in rural Sylhet District, Bangladesh.~   "
142477|NCT01702389|"~     Remifentanil is a rapid-acting opioid which has been widely used in pain treatment during~     surgery for the last 15 years 1. Remifentanil is rapidly eliminated (minutes) from the body~     after end of infusion, and this makes it easily manageable compared to other opioids.~     However, there are both experimental and clinical studies indicating that remifentanil, after~     end of infusion, triggers increased pain sensation and increased opioid consumption~     post-operatively. Increased post-operative opioid consumption should be avoided due to the~     adverse effects of these drugs (nausea/vomiting, pruritus, dizziness, fatigue and reduced~     respiratory rate). Thus, it's important to investigate relevant strategies to avoid the~     increased pain sensation (opioid-induced hyperalgesia = hypersensitivity to pain stimuli)~     after end of infusion of remifentanil after surgery. Several experimental and clinical trials~     have been conducted in this field. Ketamine has been shown to block this effect, but its~     adverse effect profile (i.a. hallucinations) makes it not suitable in normal clinical use. In~     a study of healthy volunteers, it has been demonstrated that parecoxib (a COX-2 selective~     NSAID) can prevent remifentanil-induced hyperalgesia. Our group has previously shown that a~     relatively COX-1 selective NSAID (ketorolac) can prevent hyperalgesia in an experimental pain~     model.~      This is of interest since NSAIDs are frequently administered as premedication before surgery.~     There are several disadvantages associated with the use of COX-2 inhibitors, e.g. the risk of~     myocardial infarction after long-term use (> 1 year), and potentially reduced bone healing~     after orthopedic surgery. However, this has not been shown with short-term use (days/week).~     The disadvantages associated with the use of e.g. ketorolac (a COX-1 inhibitor) are i.a.~     increased bleeding tendency, which is unfavourable for the surgeon, and increased risk of~     gastric ulcer. Therefore, it is of interest to investigate other ways of preventing~     opioid-induced hyperalgesia. In a recent animal study it has been shown that gradual dose~     reduction of remifentanil (vs. abrupt withdrawal of a relatively high remifentanil dose) can~     prevent the development of hyperalgesia after end of infusion. In this study we will i.a.~     investigate whether this is also the case in humans. In this new model, the study~     participants will get remifentanil infusion with two different dose reduction regimes:~     gradual reduction or abrupt withdrawal.~   "
142478|NCT01702376|"~     This will be a randomized, placebo-controlled, single, oral dose, four-way Williams crossover~     study design in healthy male and female subjects. The study consists of screening (28 days),~     treatment (1 day/dosing session) and follow-up (7 to 14 days) period and the total duration~     of study participation for each subject will be approximately 9 weeks. Each subject will~     participate in 4 dosing sessions separated by a minimum 7-day washout period. All subjects~     will receive single doses of retosiban 100 mg, (treatment A) retosiban 800 mg (Treatment B),~     moxifloxacin 400 mg (Treatment C) and placebo (Treatment D) in one of the four treatment~     sequences (ABDC, BCAD, CDBA, DACB) following a Williams design Twelve-lead ECGs and~     continuous Holter monitoring, clinical laboratory safety tests, vital sign measurements,~     physical examinations, adverse event reports, and pharmacokinetic samples will be collected~     throughout the study. In each study period, cardiac conduction will be measured using a~     24-hour continuous 12-lead Holter monitor from the morning of Day 1 (dosing) until the~     morning of Day 2.~   "
142479|NCT01702363|"~     The objective of this study is to evaluate the safety and tolerability of GSK573719~     Inhalation Powder 125 mcg once-daily over 52 weeks in Japanese subjects with COPD.~   "
142480|NCT01702350|"~     GSK2251052 is a member of a novel mechanistic and structural class of antibiotics that~     inhibits the bacterial enzyme leucyl tRNA synthetase (LeuRS) by forming a boron adduct with~     tRNA and is currently in development for the treatment of hospital acquired Gramnegative~     infections.~   "
142481|NCT01702337|"~     This study compares the health and economic impact of the bivalent HPV vaccine (HPV-1) and~     the quadrivalent HPV vaccine (HPV-2).~   "
142482|NCT01702324|"~     The purpose of this study is to determine the efficacy of DD-25, a new topical drug, on~     plaque Psoriasis Vulgaris.~      The study will include subjects at plaque stage from 5-20% body area involvement. A total of~     30 subjects will be treated with cream application on affected areas twice daily for three~     weeks.The efficacy of the preparation will be documented by PASI score, Global physician~     assessment and photos.~   "
142483|NCT01702311|"~     Capillary point-of-care (POC) testing is advocated as a valuable aid in the management of~     diabetes and hyperglycemia in the hospital setting. POC testing aims at collecting~     information on BG levels at different time points during the day in order to assess glycemic~     control and to guide insulin adjustment/correction doses. Although POC testing provides~     insights into day-to-day excursions in BG levels, bedtime BG testing triggers the use of~     insulin supplements that may result in increased frequency of hypoglycemia and is expensive~     with an estimated annual cost in hospitals of several hundreds of millions of dollars in the~     U.S. Accordingly, this pilot study aims to assess the utility of POC and insulin~     supplementation (correction doses) at bedtime in improving glycemic control and in preventing~     hypoglycemia in non-ICU patients with type 2 diabetes mellitus (T2DM). A total of 250 non-ICU~     medical and surgical patients treated with basal bolus regimen will undergo POC testing~     before meals and bedtime (standard of care) and half of the patients will receive insulin~     correction doses at bedtime for BG > 140 mg/dL following a sliding scale protocol, while the~     other half will be followed without insulin supplementation at bedtime except for extreme~     hyperglycemia (BG > 350 mg/dl). Patients will be recruited at Emory University Hospital and~     Grady Memorial Hospital.~   "
142484|NCT01702298|"~     The purpose of this study is to examine the safety and tolerability of sitagliptin 100~     mg/simvastatin 40 mg FDC (MK-0431D) in Vietnamese participants with type 2 diabetes mellitus~     with inadequate glycemic control on metformin.~   "
142485|NCT01702285|"~     The main purpose of this study is to determine the safety and tolerability of orally~     administered CUDC-101 in cancer patients, and to determine a dose for further testing. This~     study will also determine how well CUDC-101 is absorbed into the blood after being given~     orally, assess CUDC-101 blood levels and what happens to the study drug in the body, and~     study how the body reacts to the study drug and what effects it has on tumors. CUDC-101 has~     been administered to cancer patients as an intravenous (IV) infusion in other research~     studies, but has not been studied when given orally.~   "
142486|NCT01702272|"~     The objective of this study is to test individual donor samples (IDSs) with the~     investigational Dengue Assay on the TIGRIS System and to further characterize the Dengue~     Assay in the clinical setting.~   "
142487|NCT01702259|"~     The purpose of this study is to determine whether the application of green diode low level~     laser light therapy is effective in reducing the appearance of cellulite in the thighs and~     buttocks.~   "
142488|NCT01702246|"~     The purpose of this study is to determine whether simvastatin is effective in reducing the~     frequency and intensity of vaso-occlusive pain episodes in patients with sickle cell disease.~   "
142489|NCT01702233|"~     To evaluate functional, clinical, and subjective parameters in patients with rotator cuff~     syndrome and bursitis treated with Traumeel® S injections versus corticosteroid injections~     and versus placebo. 160 patients are planned to be randomised (i.e., 64 patients per active~     treatment group and 32 patients in the placebo group) in 9 investigator sites in Germany,~     Belgium and Spain.~      Finally 176 patients have been randomized (73 Traumeel, 67 Fortecortin and 36 Placebo) and~     175 of them received at least one dosage of treatment~   "
142490|NCT01702220|"~     The overall goals of the proposed research study are to: (1) examine quantitative outcomes in~     a well-conducted randomized clinical trial of Calmer Life, relative to Enhanced Community~     Care, an information and referral intervention that represents care in a real-world~     community-service environment, and (2) evaluate implementation feasibility, which includes~     training community providers; examining program reach, engagement, acceptability, and~     barriers-facilitators; and preparing practical tools for replicating the program.~   "
142503|NCT01702051|"~     Islet autotransplantation (IAT) is a therapeutic approach used to prevent pancreatogenic~     diabetes or to reduce the severity of diabetes after a major pancreatectomy. Total~     pancreatectomy with IAT is being used almost exclusively for treatment of chronic~     pancreatitis. More recently, indications other than chronic pancreatitis have been reported~     including IAT after extended pancreatectomy performed for the resection of benign tumors of~     the mid-segment of the pancreas or IAT after total pancreatectomy for severe abdominal trauma~     In this study, we study our experience with IAT for the treatment of a broader population of~     patients undergoing pancreatic surgery including subjects with technically unfeasible or high~     risk pancreatic anastomosis during partial pancreatectomy and subjects undergoing completion~     pancreatectomy because of anastomosis leakage after pancreatoduodenectomy for nonmalignant or~     malignant diseases.~   "
142491|NCT01702207|"~     Current standard prophylactic immunosuppression in renal transplantation includes tacrolimus,~     a calcineurin inhibitor, dosed twice daily. In Canada, oral tacrolimus has been available as~     a twice daily formulation marketed as Prograf® since 1997. It has recently become available~     in an extended release formulation called Advagraf®, which is dosed once daily. Advagraf® has~     been demonstrated to be therapeutically equivalent to Prograf® in the renal transplant~     maintenance population, and as a result it has been is approved as an alternative to the~     twice daily formulation in these patients. There is an evolving and expanding positive~     clinical experience with Advagraf® in kidney transplantation and it has shown to be preferred~     by many patients, due to the diminished dosing frequency. In clinical trials, Advagraf® has~     been shown to have other potential benefits over Prograf® such as less inter and~     intra-patient variability, improved cardiovascular profiles, and improved kidney function.~     Compared to Prograf®, Advagraf® also has a lower Cmin or 'trough' concentration as well as a~     lower Cmax or 'peak' concentration. The purpose of this study is to convert stabilized renal~     transplant patients currently receiving Prograf® to Advagraf®, to investigate these potential~     therapeutic benefits.~      The Framingham Risk Score and the Reynold's Risk Score are currently recommended by the~     Canadian Cardiovascular Society (CCS) to predict 10-year cardiovascular risk in the general~     population. Surrogate markers are widely used in clinical trials to shorten follow-up~     durations. In this study, the investigators will use the Framingham Risk Score and Reynold's~     Risk Score to quantify changes in estimated cardiovascular risk. The investigators also~     intend to examine novel inflammatory markers to investigate cardiovascular risk.~      The investigators hypothesize that the more consistent drug exposure and lower Cmax noted~     with Advagraf® will decrease Framingham Risk Score, Reynolds Risk score as well as markers of~     inflammation in kidney transplant recipients.~   "
142492|NCT01702194|"~     The purpose of this study is to determine TD-1211 is processed by the body.~   "
142493|NCT01702181|"~     The purpose of this study is to investigate the pharmacokinetics and safety of OPA-15406 in~     adult subjects with atopic dermatitis~   "
142494|NCT01702168|"~     Aim: To identify, assess, and address organizational context and provider-level barriers and~     facilitators of implementation of Evidence-based treatments (EBTs) using a mixed-methods~     approach in a diverse community mental health center (CMHC), Massachusetts General Hospital~     Chelsea Health Clinic (MGH Chelsea).~      Hypothesis: Anticipated barriers may include, but are not limited to, organizational climate,~     heavy case-loads, community mental health workers (CMHW) beliefs about EBTs, and provider~     motivation to learn EBT.~   "
142495|NCT01702155|"~     The purpose of this study is to determine the safety and efficacy of DFP-10917 given via~     continuous 7 or 14 day infusion to patients with acute leukemias (AML or ALL).~   "
142496|NCT01702142|"~     A team of researchers from the University of Wisconsin-Madison College of Engineering and~     Oregon Health & Science University will test whether clinician training and the use of~     organizational change strategies are sufficient for disseminating an evidence-based practice~     (EBP), or if changes to both organizational systems and payer policy results in greater EBP~     use. Demonstrating the role of payment policy as a driver in the adoption of evidence-based~     practices could provide a contribution to dissemination and implementation science. This~     study will employ an intervention that was developed through the Robert Wood Johnson~     Foundation-funded Advancing Recovery (AR) program. In AR, payer/treatment organization~     partnerships in 12 states collaborated to remove systemic barriers to the adoption of EBPs~     such as medication-assisted treatment for substance abuse disorders. The resulting AR~     Framework of payer and organizational change strategies will be tested against its ability~     to increase the use of the addiction medication buprenorphine as compared to organizational~     change strategies alone. Buprenorphine is an EBP for treating people addicted to heroin or~     opioid-based pain medications for non-medical use. Buprenorphine has experienced low adoption~     rates and is not a standard part of addiction treatment. In Ohio, the location of the study,~     deaths to due to accidental overdoses of opioids has increased by 304% over the past decade~     and surpassed auto accidents as the leading cause of accidental deaths in 2006. Ohio was~     selected for the study because of the public health significance of opioid abuse and because~     each county in Ohio acts as a stand-alone payer, offering 48 unique eligible payer~     environments. This trial will develop a deeper understanding of the role payers and treatment~     organizations play in implementing and disseminating EBPs and will focus on the public health~     issue of rising opioid abuse.~   "
142497|NCT01702129|"~     Background: Site-specific delivery of anti-cancer therapeutics is paramount for both reducing~     nonspecific toxicities and increasing efficacy of chemotherapeutic agents. Due to their small~     molecular size and nonspecific mechanisms of action, most conventional chemotherapies result~     in significant toxicities that limit the effectiveness of treatment and reduce the overall~     quality of life for cancer patients. Encapsulation of these toxic agents inside lipid-based~     carrier systems (so-called liposomes) results in passive targeting of the compounds to solid~     tumors. The preferential delivery of liposomal drugs to solid tumors is mostly due to altered~     barrier-properties of tumor-associated vessels. This results in both an improved delivery and~     at the same time a significantly milder toxicity profile. Recently, the specificity of~     delivery was further increased by attaching monoclonal antibodies or antibody fragments to~     the surface of liposomes (=immunoliposomes, antibody-linked nanoparticles). Antibody-coated~     immunoliposomes attach more selectively to antigens expressed on the target cells and they~     are internalized more efficiently. Furthermore, there is evidence that drug resistance, a~     major challenge in cancer treatment, may be overcome by such delivery systems. A logical and~     accessible target, such as EGFR, is overexpressed on a variety of primary human cancer cells~     and it is involved in signaling pathways that contribute both to tumor initiation and tumor~     progression. Recently, the investigators have tested immunoliposomes against the epidermal~     growth factor receptor (EGFR) in a preclinical setting. Based on the preclinical results we~     have initiated this phase I clinical trial.~      Study hypothesis: The investigators hypothesize that anti-EGFR-immunoliposomes selectively~     deliver cytotoxic compounds to EGFR-overexpressing tumors cells. Specific delivery is~     supposed to increase efficacy while reducing side-effects of the compound. The primary~     objective of this phase 1 trial is the determination of the maximum tolerated dose (MTD) for~     future phase 2 trials of this nanoparticle.~   "
142498|NCT01702116|"~     This is a study that compares two types of surgery for rectal cancer. There are two~     procedures that can be used during this surgery, conventional abdominal resection (APR) and~     extended (or extralevator) APR. The investigators are doing this research to see whether the~     extralevator APR increases the likelihood that the edge of the tissue that is removed will be~     more likely to be free from cancer cells compared with the conventional APR surgery. At this~     time there is no evidence that one type of procedure is better at this than the other. The~     objective of this research is to determine whether extralevator APR is more likely to have~     clean margins (free of cancer) compared to the standard APR surgery.~   "
142499|NCT01702103|"~     Demonstrate the therapeutic clinical equivalence of two mometasone nasal sprays in the relief~     of the signs and symptoms of perennial allergic rhinitis, in term of changes at week 8 from~     baseline of Total Nasal Symptom Scores (TNSS).~   "
142500|NCT01702090|"~     The purpose of this study is to provide early access to TMC114 administered with low-dose~     ritonavir (TMC114/r) and other antiretrovirals (ARVs) for HIV-1-infected patients who have~     not received previous HIV treatment or have received early treatment without TMC114 regimens.~   "
142501|NCT01702077|"~     The aim of this study is to train patients with tic disorders to control activity in a region~     of their brain that has been associated with the urge to tic. Patients will be given direct~     feedback regarding activity in this brain area while they are undergoing functional magnetic~     resonance imaging (fMRI) scanning, and will try to learn to control activity in the region~     during these feedback sessions. In separate sessions, patients will be given sham feedback~     based on the brain patterns of a prior subject rather than their own brain patterns. Our~     primary hypothesis is that the biofeedback training will reduce their tic symptoms more than~     the sham feedback.~   "
142502|NCT01702064|"~     This study is designed to determine the maximal tolerated dose of Ruxolitinib in combination~     with nilotinib in patients with chronic myeloid leukemia (CML).~   "
142507|NCT01701999|"~     Study rBV A/B-CL-001 is a Phase 2b, 2-part, open-label, uncontrolled study to evaluate~     safety, tolerability, and immunogenicity of a single dose of recombinant botulinum vaccine~     A/B (rBV A/B) for the production of BabyBIG in volunteers previously immunized with the~     pentavalent botulinum (PBT) toxoid. This study is designed to determine neutralizing antibody~     levels for botulinum toxin types A and B in healthy subjects who were previously immunized~     with the PBT for occupational protection and who receive the rBV A/B. Subjects with titers of~     the neutralizing antibodies against the toxins would be candidates for plasma donation for~     BabyBIG production.~   "
142508|NCT01701986|"~     Any time the words you, your, I, or me appear, it is meant to apply to the potential~     participant.~      The goal of this clinical research study is to find the highest tolerable dose of gemcitabine~     (out of 6 possible doses) that can be given in combination with busulfan and clofarabine~     before an allogeneic stem cell transplant. Researchers also want to learn if this combination~     can help to control lymphoma. The safety of this treatment will also be studied.~      Busulfan is designed to bind to DNA (the genetic material of cells), which may cause cancer~     cells to die. It is commonly used in stem cell transplants.~      Clofarabine and gemcitabine are designed to block the growth of cancer cells, which may cause~     the cancer cells to die.~      This is an investigational study. Gemcitabine and clofarabine are FDA approved and~     commercially available for the treatment of lymphoma. Busulfan is FDA approved and~     commercially available for use in stem cell transplantation. The combination of gemcitabine~     given in combination with busulfan and clofarabine before an allogeneic stem cell transplant~     is investigational.~      Up to 30 patients will take part in this study. All will be enrolled at MD Anderson.~   "
142509|NCT01701973|"~     This study tests the following hypotheses:~      Aim 1: Test the hypothesis that acute dipeptidyl peptidase 4 (DPP4) inhibition with the~     currently available anti-diabetic drug, sitagliptin, will increase stimulated growth hormone~     (GH) secretion in healthy lean adults by decreasing the degradation of growth hormone~     releasing hormone (GHRH).~      Aim 2: Test the hypothesis that decreased degradation of GHRH during acute DPP4 inhibition~     will result in an increase in endothelium-dependent vasodilation mediated by GH and~     independent from GLP1 (glucagon like peptide-1) in healthy lean adults.~      This study promises to provide novel data regarding how this increasingly used class of~     anti-diabetic drugs affects the pituitary GH axis and could affect blood vessel relaxation.~     Growth hormone levels are low in the setting of obesity and pre-diabetes. A further study may~     evaluate the effect of chronic DPP4 inhibitor therapy in a population of patients with~     obesity and pre-diabetes.~   "
142510|NCT01701960|"~     1% Lidocaine with 1:100,000 to 1:200,000 of epinephrine is routinely injected into the nasal~     mucosa during nasal surgery to reduce patient blood loss and improve the surgical field and~     visibility. Typically 1% lidocaine with 1:100,000 of epinephrine is used in nasal surgery.~     However, 1 % lidocaine with 1:200,000 (which is a more dilute solution of epinephrine) is~     also used. This latter dose theoretically should have a lesser effect on cardiac stimulation~     which increases the heart rate and blood pressure at the time of surgery. The nasal mucosa~     has excellent absorbing ability which is great for the application of drugs but there is~     concern for systemic absorption and side effects. Potential serious side effects can occur~     with local injection such as hypertension, tachycardia, and cardiac arrhythmias. These side~     effects occur mainly through the absorption of epinephrine. It is the goal of this study to~     see if a weaker concentration of epinephrine (1:200,000) can maintain a good surgical field~     with a decrease in hemodynamic side effects.~   "
142511|NCT01701947|"~     The objective of the Expanded Access Program is to provide HEMOLEVEN, a replacement~     coagulation factor XI, to patients with severe inherited factor XI deficiency where, in the~     opinion of the treating physician, the benefits of administering selectively the missing~     factor outweigh the potential risks associated with the administration of fresh-frozen~     plasma.~   "
142512|NCT01701934|"~     The purpose of this study is to determine whether roflumilast can improve metabolic profile~     and reduce visceral adiposity in patients with chronic obstructive pulmonary disease (COPD).~   "
142513|NCT01701921|"~     The purpose of this study is to determine whether pregabalin is effective in the treatment of~     acute postoperative pain after cardiac surgery if administered before the surgery.~   "
142514|NCT01701908|"~     Incidence of Postoperative Pulmonary Complications (PPCs) varies from 2% to 19%, according to~     the population under examination and the criteria used to define pulmonary complications.~     There is no univocal definition of PPCs. Usually physicians associate atelectasis,~     respiratory insufficiency, pneumonia, bronchospasm, necessity to reintubate. Moreover the~     evaluation of risk factors has become difficult.~      The endpoint of this study is to determine the actual incidence of respiratory postoperative~     complications in patients undergoing general anesthesia for major abdominal surgery (general~     surgery, gynecology, urology).~      This is an observational, descriptive, prospective, multicentric study. Investigators are~     going to enroll all the patients matching the inclusion criteria and follow them until~     discharge (clinical phase). Then they will be followed up until one year later.~   "
142515|NCT01701895|"~     The purpose of this research study is to evaluate how easy it is for female HIV- positive~     subjects taking Complera to comply with the dietary requirement using a food diary in the~     short term (4 weeks) and long term (24 weeks and 48 weeks) and to determine association~     between calorie intake and virologic suppression. A secondary goal of the study is to~     evaluate subjects' attitudes towards contraception.~   "
142516|NCT01701882|"~     The purpose of the study is to investigate the benefits of switching away from efavirenz~     (which patients are taking in combination with Kivexa® or as part of the combination pill,~     Atripla®) in patients with central nervous system side effects (such as insomnia {difficulty~     with sleeping}, bad dreams etc). The investigators in this study will investigate the effect~     of switching to a single tablet regimen (Eviplera®) containing tenofovir, emtricitabine and~     rilpivirine. If patients are currently taking Atripla, rilpivirine will be the only new~     component of the combination.~      Rilpivirine is a drug for HIV treatment, licensed for first-line treatment. In combination~     with Truvada®, it showed fewer side effects when compared to efavirenz in 2 other clinical~     studies, where patients were starting HIV treatment for the first time.~      This study will also investigate the safety (in terms of other side effects and the routine~     blood tests which we ordinarily use to monitor your treatment) and monitor effectiveness,~     your viral load and CD4 counts, when you switch treatment to~     tenofovir/emtricitabine/rilpivirine.~   "
142517|NCT01701869|"~     Chronic obstructive pulmonary disease (COPD) is the fourth most common cause of death and the~     only one of the common causes that is still rising. The main effects of the disease are the~     destruction and inflammation of lung tissue rendering breathing difficult. COPD has~     significant effects on the quality of life of sufferers and the disease is predicted to be~     the fifth most common cause of disability in the world by 2020. Patients with COPD are prone~     to periods of worsening disease symptoms, known as exacerbations, which are often caused by~     viral and bacterial infections of the lung and current vaccines appear to have little~     efficacy in limiting these exacerbations. The loss of lung function caused by infectious~     exacerbations is irreversible and patients who frequently exacerbate experience more rapid~     disease progression. Nontypeable Haemophilus influenzae (NTHi) is a major bacterial species~     that colonises the airways and causes exacerbations in COPD. With the development of more~     sensitive molecular techniques it has been possible to ascertain that it is the acquisition~     of new strains of NTHi that correlate strongly with exacerbations. However, not all patients~     with COPD have NTHi in their lungs and the question remains as to why some COPD patients are~     susceptible to such infections. This study aims to answer this question by comparing the~     airways of COPD patients who are colonized by NTHi and those who are not to analyse whether~     the levels of protective antibodies in the lungs and the function of the immune cells in the~     NTHi colonized airway are reduced. Moreover, we aim to correlate this reduction in immunity~     with areas of lung damage ascertained by high resolution computed tomography. The aim of this~     research is to better understand this apparent deficiency in airway immunity as this is~     likely to impact on vaccine efficacy in COPD.~   "
142518|NCT01701856|"~     Multiple Sclerosis (MS) is the most common neurological disorder causing disability in young~     adults affecting approximately 1 in 1.000 people in western countries. The clinical~     manifestations usually begin at the age of 20 to 40 years with a median age of 28 years at~     onset with acute episodes of neurological dysfunction, followed by periods of partial or~     complete remission and clinical stability in between relapses. This relapsing-remitting phase~     (RR-MS) of the disease is usually followed by progressive clinical disability (secondary~     progressive phase, SP-MS).~      At present, there is no cure for MS. Based on the pathological concept that neuroinflammation~     is the common element leading or contributing to neurodegenerative changes, immune~     interventions have been introduced into clinical practice such as Natalizumab (Tysabri), a~     humanized monoclonal antibody. Natalizumab (Tysabri) is indicated as a disease-modifying~     monotherapy of highly active relapsing MS. The associated risks, especially progressive~     multifocal leukoencephalopathy, necessitate active monitoring of patients and a continuous~     discussion of optimum use of this drug. In clinical practice, the question how to manage~     patients on natalizumab at a higher risk for progressive multifocal leukoencephalopathy~     remains unresolved.~      This prospective, controlled (comparison to the period prior to natalizumab treatment),~     single-arm, open-label, multi-centre, phase IV study aims to evaluating the concept of~     natalizumab de-escalation to interferon-beta-1b e.o.d in relapsing-remitting multiple~     sclerosis patients, who consider stopping natalizumab due to a benefit-risk assessment. In~     particular, to evaluating if interferon beta-1b treatment may be able to overcome the~     recurrence of significant clinical and radiological disease activity after natalizumab~     cessation and may keep disease activity better under control as compared to the time prior to~     natalizumab.~      The study population includes patients with relapsing-remitting multiple sclerosis (RR-MS)~     being treated at least for 12 months with natalizumab and having decided to stop natalizumab~     treatment and to de-escalate their therapy to a first line treatment with interferon beta-1b.~     They will be treated during 12 months with interferon-beta 1b 250 mcg given subcutaneously~     every other day. A 12-month follow-up period with the same treatment is planned.~   "
142519|NCT01701843|"~     The purpose of this exploratory study is to investigate the clinical efficacy of study drug~     (LP0074) in the treatment of Mastocytosis. The trial will be performed as a left/right~     comparison study in male/female subjects with mastocytosis, in a prospective, double-blinded,~     randomised, single centre setting.~   "
142520|NCT01701830|"~     The aim of the study is to evaluate whether a low level of serum omentin-1 is associated with~     carotid atherosclerosis and mediated by inflammation.~   "
142521|NCT01701817|"~     The Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF II) is a~     multicenter, prospective outpatient disease registry to evaluate the utilization of~     target-specific antithrombotic agents, such as FXa (factor Xa) inhibitors and direct thrombin~     inhibitors, and associated outcomes. Importantly, the ORBIT AF II registry will permit the~     collection and analysis of post-approval observational data needed for evaluating the~     outcomes associated with these new agents when used in broader patient populations outside of~     clinical studies. The ORBIT-AF II registry will focus on patients with newly diagnosed atrial~     fibrillation (AF) as well as those who have been recently started on a target-specific oral~     anticoagulant agent. Taken together, the ORBIT-AF I and ORBIT-AF II registries will offer a~     broad and contemporary view of AF therapy.~   "
142522|NCT01701804|"~     The purpose of this study is to investigate the effect of a non-surgical integrative package~     consisting of Chuna herbal medicine, Chuna manual therapy, bee-venom pharmacoacupuncture,~     acupuncture on failed back surgery syndrome through means of a prospective case series.~   "
142523|NCT01701791|"~     Background: In Italy, several recent studies found that a large percentage of patients~     attending Primary Care (PC) clinics meet criteria for at least one common mental disorder, as~     they show high rates of depression, anxiety, and co-morbid anxiety and depression. These~     patients may experience significant functional impairment and suffer from unexplained somatic~     symptoms, and often remain undetected and untreated. Consistent evidence for the~     effectiveness of organized care programs for depression, by improving quality of care and~     treatment adherence, is now available. Fundamental elements of these programs include~     algorithms to prompt the proper and timely implementation of evidence-based treatments,~     structured outcome assessment and systematic outreach. Telemedicine tools may represent a~     valuable strategy for improving depression outcomes in PC.~      Aims: 1.To develop and employ computer-based assessment to more accurately and timely detect~     patient depression in PC settings; 2.To evaluate the feasibility and effectiveness of a care~     support program developed in conjunction with the PC-based assessment for patients suffering~     from depression, as based on two main objectives: 2a.To support GP decisions with treatment~     algorithms and improve the quality of GP and mental health service collaboration; 2b.To~     improve patient compliance and treatment adherence by using appropriate telecommunication~     tools and technologically advanced tools to conduct systematic routine assessment. Although~     much of this system will be computer-based, live telephonic and in-person contacts will also~     be included as needed.~      Study Design: The study is a randomized controlled trial, involving four PC group clinics~     (GCs) located in two areas of Northern Italy. Two PC clinics will use the experimental~     protocol; the other two will serve as controls.~      The study will compare two different conditions:~        -  Group 1 (experimental): GPs will use a Computer Decision Support System with treatment~          algorithms and advice and supervision from a consultant psychiatrist. Patients will~          receive reminders via mobile texting or automatic mobile (or landline) phone calls to~          improve adherence to the treatment prescribed.~        -  Group 2 (control): GPs will provide TAU, will make their own decisions and will~          therefore not use the CDSS. Patients will not receive any reminders. All enrolled~          patients will be administered and will fill in the IDS-SR at baseline, 3 and 6-months:~          the IDS-SR score will be used as a primary endpoint.~   "
142524|NCT01701778|"~     The purpose of this study is to compare the effects of caudal dexmedetomidine with~     intravenous dexmedetomidine on caudal levobupivacaine analgesia in children undergoing lower~     abdominal surgeries.~   "
142534|NCT01701648|"~     Vitiligo is an acquired skin disease that significantly impacts the quality of life of~     patients. Medical treatment of vitiligo includes the use of melanocyte transplantation but~     the results are variable.~      This single center, single blind clinical trial comparing another treatment and also no~     treatment was designed to assess the efficacy of autologous monocyte transplantation in~     monolayers on a substrate of amniotic membrane for the treatment of stable vitiligo. Patients~     will receive the two interventions, melanocyte suspension and monolayer on amniotic membrane~     and will provide an untreated area as a control.~   "
142848|NCT01697514|"~     The purpose of this study is to find a recommended dose level of LY2940680 that can be safely~     given to children with medulloblastoma or rhabdomyosarcoma that has returned or doesn't~     respond to initial treatment. The study will also explore the changes in a cancer marker~     levels. Finally, the study will help document any antitumor activity.~   "
142525|NCT01701765|"~     An increasing number of severely ill patients require long-term care in non-hospital~     Residential Facilities (RFs). Despite the magnitude of this development, only a few detailed~     longitudinal studies on fairly larger samples of residents have provided important~     information about this population. The PERDOVE study is the first study carried out in Italy~     aimed at obtaining comprehensive data about the course and outcome of patients living in RFs,~     and test whether discharge to independent accommodations is a real option for many patients.~     The major aims are three: (1) to describe the sociodemographic, clinical, and~     treatment-related characteristics of patients treated in RFs during an index period in 2010;~     (2) to identify predictors, and characteristics associated to discharge at 1-year follow-up;~     and (3) to evaluate clinicians' predictions about the likelihood of home discharge for each~     individual patient. The primary endpoint was discharge within one year as a measure of good~     outcome. The PERDOVE study is an observational cohort study, involving 23 RFs all belonging~     to the St John of God Order, located in Northern Italy. The first step involves the~     evaluation of all RFs with a Structure Schedule, which assesses the following areas:~     logistics structure, general organization: internal rules, meals, clothing and personal~     hygiene; staff and users' characteristics and meetings, documentation system and evaluation~     activities; rehabilitative activities provided inside the RF itself. In the second step a~     research assistant completed a standardised assessment of each resident with the manager and~     staff; clinical diagnoses were made by treating clinicians. A number of standardised~     instruments were administered. At one year follow-up, changes in clinical and life conditions~     of the patients were evaluated and selected rating scales were administered again. For~     patients discharged to the community or to other RFs, a research assistant contacted the~     patient's psychiatrist and asked him/her to fill out the follow-up documentation. With regard~     to residents' discharge, investigators hypothesised that the likelihood of community~     discharge would be associated both with the level of social support outside the facilities,~     and with the degree of patients' psychological and social impairment.~   "
142526|NCT01701752|"~     This study will evaluate the safety and immunogenicity of FP-01.1 and FP-01.1 reformulated~     with an adjuvant (FP-01.1-Adjuvant) in relatively healthy subjects 65 to 74 years of age,~     subjects that are more representative of the target population. Both formulations will be~     administered alone or concomitantly with the Trivalent Inactivated Influenza Virus (TIV)~     vaccine.~   "
142527|NCT01701739|"~     This open-label, two-period, fixed-sequence study will investigate the pharmacokinetics and~     safety of multiple doses of aleglitazar on a single dose of digoxin in healthy volunteers. In~     period 1, volunteers will receive a single dose of digoxin, in period 2 volunteers will~     receive multiple doses of aleglitazar and a single dose of digoxin. The anticipated time on~     study treatment is one month.~   "
142528|NCT01701726|"~     This is a large scale, open-label, multicenter, randomized controlled clinical trial with~     four parallel arms. This trial aims to evaluate the effectiveness of affected meridian~     acupuncture for patients with mild hypertension,with respect to decreasing their blood~     pressure, safety of acupuncture ,and improving their quality of life as well.~   "
142529|NCT01701713|"~     The purpose of this study is to determine the safety of transcranial direct current~     stimulation in aphasia therapy in acute and post-acute stroke.~   "
142530|NCT01701700|"~     Over 1 million people in the UK suffer from untreatable visual impairment, many of them~     elderly. The major complaint of visually impaired people is their inability to carry out~     simple tasks, especially those involving reading. It is known that this activity limitation~     is a major cause of depression in an older population, and it is reflected in reduced quality~     of life. Low vision clinics, mostly based within hospital ophthalmology departments, dispense~     optical magnifiers to allow patients to carry out these tasks again, but these devices do~     have limitations (unusual posture, short working distance, monocular viewing). Although~     electronic magnifiers have been around since the 1960s, they were initially very large and~     expensive. Recent advances in technology have brought about an explosion in the number and~     range of portable and moderately-priced aids, which can be used binocularly, in a natural~     working position: these are currently not available through the NHS. Evidence is needed as to~     whether these portable hand-held electronic magnifiers could offer a significant benefit to~     the majority of patients, and therefore whether they should be routinely dispensed in low~     vision clinics.~      The proposed study is a two-arm randomised crossover trial with existing users of optical~     magnifiers being assigned to use a hand-held electronic magnifier in addition to their~     existing devices for 2 months. Reading and task performance will be measured with the aid,~     and compared to the performance with optical aids, and the patient will be asked to report on~     the comparisons between the aids.~   "
142531|NCT01701687|"~     Fibroscan is a non invasive imaging investigation which measures liver stiffness, known to~     correlate well with liver scarring and cirrhosis on liver biopsy. Indocyanine green is an~     inert dye which is purely extracted from the blood by liver cells, and is hence an excellent~     marker of both liver cell function and overall liver blood flow. There is little data for~     either of these biomarkers regarding outcomes in alcoholic liver disease. We aim to establish~     the accuracy of these liver biomarkers in predicting important liver related outcomes (death,~     transplantation and hospital readmission with cirrhosis related consequences) in patients~     with severe (decompensated) alcoholic liver disease. Moreover, we will assess whether the~     serial measurement of biomarkers has any impact on alcohol abstinence, motivation or quality~     of life. Over an 18 month period, 125 consecutive hospital inpatients with decompensated~     alcoholic liver disease will undergo baseline biomarker measurement, routine blood and urine~     tests and qualitative questionnaires. These will be measured during their initial hospital~     admission (0 months) with subsequent repeat measurement during follow up visits at 1, 2, 4~     and 6 months. Each study visit time will be in the region of 30-40 minutes to complete these~     investigations. The end of the study for individual patients will be patient death, liver~     transplantation or 6 month from study enrolment; whichever occurs first.~   "
142532|NCT01701674|"~     Purpose of this Pilot Study: The investigators want to study the safety, side effects, and~     benefits of tumor infiltrating lymphocytes (TILs), when they are given with the drug~     ipilimumab. Ipilimumab is a type of immunotherapy - a drug that is used to boost the ability~     of the immune system to fight cancer, infection, and other diseases.~   "
142533|NCT01701661|"~     Randomized controlled trial, a method used to implement the random allocation sequence is~     numbered containers.~      The aim of the study is to compare compression therapy with compression stockings and surgery~     eliminating superficial venous reflux in patients with duplex ultrasound verified superficial~     venous reflux without skin changes or ulceration.~   "
142547|NCT01701479|"~     The main aim of this clinical trial is to find a way of giving ch14.18/CHO, in combination~     with subcutaneous aldesleukin (IL-2) and oral isotretinoin (13-cis-RA), to children and young~     people with primary refractory or relapsed neuroblastoma without intravenous morphine.~   "
142548|NCT01701466|"~     The purpose of this study is to determine whether NeoVIDERM is effective at preventing~     radiation dermatitis in patients receiving external beam radiation therapy to the head and~     neck or breast areas.~   "
142535|NCT01701635|"~     A culturally-relevant, theoretically and empirically sound, patient-centered, standardized~     disclosure intervention that can be integrated into routine clinical pediatric HIV care has~     potential to prevent transmission and improve the welfare of children and their caregivers in~     Ghana and other resource-limited settings. Results from this project will also further an~     understanding of factors and processes driving pediatric HIV disclosure.The study hypothesis~     is that several key barriers to disclosure of HIV status can be modified and the process of~     disclosure promoted with an intervention approach that is grounded in a traditional Ghanaian~     concept.~   "
142536|NCT01701622|"~     Hyperuricemia (high uric acid level) has been correlated to hypertension (high blood~     pressure) and overall cardiovascular disease risk in several studies. The relationship has~     even been noted to be independent of metabolic syndrome and kidney function. It has been~     repeatedly noted that hyperuricemia was an independent risk factor of death in those at high~     cardiovascular disease risk. A recent review concluded that there is strong evidence that~     hyperuricemia and gout are coupled with atherosclerosis and cardiovascular events.~      Although this correlation of hypertension and hyperuricemia is known, there has only been one~     published study that has evaluated if lowering the uric acid would reduce the blood pressure.~     The authors concluded that in newly diagnosed hypertensive adolescents, allopurinol decreased~     the blood pressure. Despite this, further evaluation of this therapeutic approach has not~     been studied.~      The hypothesis of this study is that febuxostat, a new xanthine oxidase inhibitor, has blood~     pressure lowering effects superior to allopurinol in patients diagnosed with gout.~   "
142537|NCT01701609|"~     Cognitive Remediation Therapy (CRT) can enhance cognitive performance in schizophrenia~     improving functional outcome. But most of the studies have involved participants who are in~     average in their mid 30s, and little is known about the efficacy of CRT in adolescents with~     early-onset schizophrenia (EOS). The aim of this study is to investigate efficacy of CRT in~     improving cognitive performance and functional outcome in adolescents with EOS. We expect to~     find that CRT improves cognitive and functional outcomes in adolescents with schizophrenia.~   "
142538|NCT01701596|"~     This study is aimed at examining the safety and efficacy of rotational atherectomy (RA) in~     nondilatable calcified lesion complicated by coronary dissection during percutaneous coronary~     intervention (PCI) procedure.~   "
142539|NCT01701583|"~     This study looks at changes in cell proteins in people with chronic hives treated with~     omalizumab.~   "
142540|NCT01701570|"~     The investigators plan to learn more about how different levels of exercise feel to people~     with Type 2 Diabetes and how it feels to people without Type 2 Diabetes. This study team will~     also look at what causes exercise to feel harder or easier to people with and without Type 2~     Diabetes. The investigators will also compare the potential benefits of supervised exercise~     training to that of diabetes education/blood sugar monitoring.~   "
142541|NCT01701557|"~     Randomized trial to determine if the volume of fluid administration in pediatric patients~     with DKA impacts the rate of normalization of serum bicarbonate, pH as well as the length of~     treatment~   "
142542|NCT01701544|"~     We will perform a pilot study to evaluate the effectiveness of human NBM DBS at improving~     cognitive deficits in PD patients referred and eligible for conventional DBS treatment for~     coexisting motor impairments. Six patients with PD with both motor fluctuations and cognitive~     impairments (including but not restricted to deficits in attention and working memory) will~     have bilateral electrodes implanted to ensure that superficial contacts lie in the~     conventional motor GPi target, while the deepest electrical contacts lie in the NBM- (see~     figure 1). We will place electrodes using our conventional image guided, stereotactic~     frame-based procedure currently used in patients at NHNN. Patients will be randomised into 2~     groups in a crossover trial design to have 3 month periods of NBM stimulation switched on or~     switched off separated by a 1 month washout period, following which the patient will cross~     over to have the opposite condition for a further 3 months- see timeline. At the end of the~     crossover period, all patients will be invited for continued follow up with stimulation~     switched on and will have neuropsychological evaluations at 6 monthly intervals. Patients~     will be given the option of receiving additional conventional stimulation to the motor GPi,~     through the higher contacts of each electrode, at the end of the crossover period.~   "
142543|NCT01701531|"~     The objective of this study is to measure the change in hemoglobin levels after the~     administration of an amino acid based, RBC precursor formulation.~   "
142544|NCT01701518|"~     To determine if an intravitreal sustained release dexamethasone implant (Ozurdex®) injected~     at the conclusion of surgery in patients undergoing vitrectomy and membrane peeling for~     idiopathic epiretinal membranes is safe and effective to decrease the macular edema, as~     demonstrated by a gain in vision and decreased in retinal thickness and volume.~   "
142545|NCT01701505|"~     The purpose of this study is to assess the efficacy and safety of intranasally administered~     Kovacaine Mist for anesthetizing maxillary teeth in pediatric subjects.~   "
142546|NCT01701492|"~     This is an observational study to collect information by use of performance-based measures~     and survey questionnaires. It does not include interventions aimed at altering patient~     outcome.~      Advances in pediatric hematopoietic stem cell transplantation (SCT) have resulted in improved~     survival and prompted increased attention to the potential adverse late effects of this~     procedure. Survivors of SCT are thought to be at risk for neurocognitive deficits as a result~     of their exposure to a number of potentially neurotoxic agents. Prior studies done by our~     group and others have demonstrated generally stable cognitive function in the first 5 years~     following transplant, with little evidence of significant declines. However, there has been~     almost no research to date on the status of very long-term (> 5 years post-transplant)~     survivors. In this study, we will evaluate a large sample of long-term survivors of~     allogeneic SCT using measures of intelligence, academic achievement, and specific cognitive~     functions such as attention, working memory and processing speed. We will also obtain~     measures of behavioral functioning and quality of life. We will examine how this group of~     survivors are functioning relative to normative expectations, and in comparison to community~     controls without a history of serious illness, matched on age, gender, race/ethnicity, and~     socioeconomic status. We will also examine the relationship between cognitive function and~     psychosocial function and quality of life in this population.~   "
142549|NCT01701453|"~     1. Objective : To test the safety of 6 month-duration of dual antiplatelet therapy (DAPT)~          compared to conventional 12-month-or-longer duration after second-generation~          drug-eluting stent (DES) implantation in patients with acute coronary syndrome (ACS).~        2. Hypothesis : A 6-month duration of DAPT is non-inferior to a conventional 12-month-or~          longer duration of DAPT at preventing the occurrence of major adverse cardiac and~          cerebrovascular events (MACCE) at 18-month after second-generation DES implantation in~          patients with ACS.~   "
142550|NCT01701440|"~     In this study we propose to test the Biofusionary Bebe in order to reduce skin laxity and~     improve contour and cosmesis.~   "
142551|NCT01701427|"~     Sensory disturbances in persistent postherniotomy pain, include hyperalgesia from deeper~     structures as well as the skin. Whether this is one combined pain syndrome, where for~     instance deep pain leads to cutaneous hyperalgesia, or two isolated synchronous pain~     conditions, is unknown. By Giving pain free subjects an intense non-harmful electrical~     stimulation in deeper tissues in the groin and recording the skin sensory function, this~     hypothesis will be tested~   "
142552|NCT01701414|"~     The purpose of this study is to determine if ultrasound guided femoral nerve blocks~     (localized anesthesia in the upper thigh) provide effective pain relief in adult patients~     with hip fractures in the emergency department and to determine if femoral nerve blocks can~     then be used to reduce the use of injected analgesia (anesthesia), therefore also causing~     fewer adverse effects associated with injected analgesia (such as bruising at the site of~     injection).~      100 patients with hip fractures will be enrolled in the study. Patients will be randomly~     assigned to receive a femoral nerve block (FNB) plus injected analgesia or standard care~     (SC), which is injected analgesia alone.~      Using guidance from an ultrasound machine, the FNB group will have 20ml of 0.5% bupivacaine~     (a local anesthetic of long duration) injected into the front of the thigh, at the site of~     pain. Patients randomized to the SC group will receive an injection of saline (saltwater) so~     that no neither the patient or the treating physician knows to which group the patient was~     randomized. All blocks will be performed in the emergency department by an emergency~     physician trained in the use of ultrasound and ultrasound guided nerve blocks.~      Subjects will be asked to rate their pain on a numeric pain scale both before and after~     intervention (30 min, 60 min, 12 hrs and 24 hrs after injection, as long as the patient is in~     the ER still). Additional data to be collected includes demographics, vital signs, and course~     of treatment resulting from the ED visit.~      Hypothesis: US-guided femoral nerve blocks can provide effective pain control and possibly~     decrease or eliminate the need for narcotics.~   "
142553|NCT01701401|"~     The purpose of this study is to evaluate the safety, tolerability, and antiviral efficacy of~     ledipasvir (LDV)/sofosbuvir (SOF) fixed-dose combination (FDC) tablets with or without~     ribavirin (RBV) administered for 12 and 24 weeks in treatment-naive subjects with chronic~     genotype 1 HCV infection.~   "
142554|NCT01701388|"~     This study seeks to test the safety and efficacy of the Esko device in SCI population and in~     populations with similar neurological weakness to the SCI population. The device can~     currently stand from a seated position, walk, and turn and sit down. Our hypothesis are as~     follows:~        -  Hypothesis 1: We hypothesize that the Ekso subject will significantly improve balance~          while wearing the device as noted by subject's ability to safely achieve standing~          balance for 30 sec without loss of balance.~        -  Hypothesis 2: We hypothesize that the Ekso subject will display improved ability to~          safely ambulate 10 meters to be assessed using the 10 meter walk test.~        -  Hypothesis 3: We hypothesize that the Ekso subject will display improved weight shift in~          both static and dynamic activities as determined by a trained physical therapist.~        -  Hypothesis 4: We hypothesize that the Ekso subject will verbalize improved success with~          training of the device as noted by subjective questionnaires that will be assessed~          following each training session.~   "
142555|NCT01701375|"~     1.1 Primary Objectives~        -  To determine the feasibility, tolerability, and toxicities of administering the~          selective CDK 4/6 inhibitor PD 0332991 prior to the combination of ara-C and~          Mitoxantrone for adults with relapsed and refractory acute leukemias and high risk~          myelodysplasias (MDS), including primary refractory disease~        -  To determine the direct cytotoxic effects of single agent PD 0332991 on malignant blasts~        -  To determine the maximal tolerated dose (MTD) of PD 0332991 in timed sequential~          combination with ara-C and Mitoxantrone~        -  To determine if the timed sequential combination of PD 0332991 with ara-C and~          mitoxantrone can induce clinical responses in adults with relapsed or refractory acute~          leukemias and high-risk MDS~      1.2 Secondary Objectives:~        -  To determine the ability of PD 0332991 to directly induce apoptosis in malignant cell~          populations in vivo~        -  To obtain pharmacodynamic (PD) data regarding the ability of PD 0332991 to arrest~          malignant cells in the G 1 phase of cell cycle, followed by synchronized release of~          those cells into S phase upon discontinuation of PD 0332991 and resultant enhanced ara-C~          cytotoxicity~   "
142556|NCT01701362|"~     This study is designed to investigate if pregabalin is effective in treating neuropathic~     (nerve) pain resulting from peripheral nerve trauma due to a traumatic or surgical event such~     as, for example, motor vehicle accident, fall, sports injury, knee or hip replacement, hernia~     repair, thoracotomy, mastectomy, focal/localized burns or crush injury.~   "
142557|NCT01701349|"~     This is a multicenter, double-blind, placebo-controlled, randomized study of fosbretabulin~     given with chemotherapy (paclitaxel and carboplatin) compared to placebo given with~     chemotherapy (paclitaxel and carboplatin) in subjects with anaplastic thyroid cancer (ATC).~     The primary objective of the study is to determine overall survival. A maximum of 300~     subjects will be recruited from approximately 75 multinational sites of which approximately~     35 will be located in the United States.~   "
142558|NCT01701336|"~     The purpose of this study is to determine whether administration of recombinant IMPs Ad6NSmut~     and MVA-NSmut (experimental vaccines for hepatitis C) in HCV chronically infected patients in~     combination with the standard Interferon/ribavirin therapy is safe and induces an~     immunological response.~   "
142656|NCT01700049|"~     The purpose of this study is to investigate the safety and effectiveness of oral vismodegib~     therapy in the treatment of different 'histologic subtypes' of basal cell skin cancer (BCC).~     The term 'histologic subtype' refers to how the cells and tumor tissue looks under the~     microscope. Three different 'histologic subtypes' of basal cell skin cancer~     (infiltrative/morpheaform, nodular and superficial) will be examined in this study.~   "
142559|NCT01701323|"~     This pilot clinical trial studies infusion of laboratory-grown donor cord blood cells~     following combination chemotherapy in treating younger patients with acute myeloid leukemia~     that has returned or that does not respond to treatment. Chemotherapy drugs work in different~     ways to stop the growth of cancer cells, either by killing the cells, by stopping them from~     dividing, or by stopping them from spreading. Chemotherapy also kills healthy~     infection-fighting cells, increasing the risk of infection. The infusion of laboratory-grown~     cord blood cells may be able to replace blood-forming cells that were destroyed by~     chemotherapy. This may decrease the risk of infection following chemotherapy, and allow for~     more chemotherapy to be given so that more cancer cells are killed.~   "
142560|NCT01701310|"~     116 eligible patients with confirmed non-metastatic colorectal adenocarcinoma and anemia will~     be randomized to receive either oral ferrous sulphate (control) or intravenous ferric~     carboxymaltose (intervention).~      It is hypothesized that intravenous iron supplementation is more efficacious than oral iron~     therapy.~   "
142561|NCT01701297|"~     Research question: Do oral probiotics in patients with cirrhosis and ascites reduce~     intestinal bacterial concentrations, ascitic bacterial DNA, SBP and bacteraemia compared to~     antibiotics or placebo?~      This study is designed to investigate the effects of an oral probiotic (VSL#3; a mixture of~     healthy bacteria for the intestines) compared to an antibiotic or placebo in preventing~     infection developing in the abdominal fluid (ascites) that collects in patients with~     advanced liver disease (cirrhosis). Patients already having had infection will be excluded~     from the study. Clear inclusion and exclusion criteria will be met and patients will be~     monitored throughout the study to examine whether they have required more hospitalisations,~     their rate infection in abdominal fluid or elsewhere and the level of liver function.~   "
142562|NCT01701284|"~     Cancer is a leading cause of mortality and morbidity worldwide. In addition, cancer is~     associated with high rates of depression and anxiety among its sufferers, and cancer patients~     with depression usually have worse treatment outcomes and long-term survival. Surprisingly,~     many cancer patients with depression do not receive treatment for their depression, perhaps~     because treatments for cancer-related depression are usually adapted from those used in~     non-cancer populations and may not be suitable for cancer patients. Moreover, cancer patients~     with depression are more likely to have a long latency of anti-depressant drug action,~     negative drug-drug interactions with cancer chemotherapies and an increased susceptibility~     for systemic side effects. Repetitive transcranial magnetic stimulation (rTMS) is a new~     treatment modality for depression that affects the brain directly with no systemic side~     effects and poses no potential for drug-drug interactions. rTMS therapy was recently cleared~     by the FDA as an antidepressant treatment for treatment-resistant Major Depressive Disorder,~     and now is being evaluated for a wide array of additional psychiatric indications. This~     randomized, open label, two-arm, pilot study will investigate the safety, tolerability,~     feasibility and the efficacy of two forms of rTMS (i.e., left (fast) and right (slow) sided~     rTMS) in cancer-related depression. The study hypotheses are that rTMS will significantly~     reduce symptoms of depression and that right-sided slow rTMS will be more effective than~     left-sided fast rTMS for the treatment of severe anxiety.~   "
142563|NCT01701271|"~     The purpose of this study is to determine whether the Hair Loss Prevention Lotion named~     MEXIS, M.P.A.F., M6S PATENT is effective in the treatment of Androgenetic Alopecia.~   "
142564|NCT01701258|"~     The purpose of this study is to investigate brain pathways within adult females (with a~     history of CSA that occurred between the ages of 5-14) with and without a current diagnosis~     of major depressive disorder (MDD).~      Hypotheses:~      The CSA/MDD participants will be characterized by (1) reduced reward responsiveness and~     prefrontal cortex activity, but increased cortisol levels, (2) reduced dopamine activity, and~     (3) reduced dopamine transporter binding. The over-arching purpose of the study is to (1)~     identify individuals at risk for psychopathology and maladaptive behavior, (2) prevent~     re-victimization, and (3) develop more targeted therapeutic interventions.~   "
142565|NCT01701245|"~     Subjects enrolled into this 10 week study will for the first two weeks document the number of~     cluster headaches and the means of treating (medication) of these attacks. Subjects will then~     be randomized to into either two groups. The first group is continuing with standard of care~     and the second group is treatment with the investigational device (GammaCore) for a period of~     4 weeks. After this 4 week period, all subjects will treat with the GammaCore for another 4~     week period. It is hypothesized the the treatment group will have a reduction in mean cluster~     headaches per week by 50% compared to the standard of care group.~   "
142566|NCT01701232|"~     This international multi-center, randomized, controlled, open-label study investigated the~     pharmacokinetics, pharmacodynamics, efficacy and safety of BCD-020 (INN: rituximab, CJSC~     Biocad) versus MabThera® (INN: rituximab, F. Hoffmann La Roche, Ltd.) both administered as a~     monotherapy of patients with indolent non-Hodgkin's lymphoma.~      Patients were randomized to receive 375 mg/m² BCD-020 as intravenous infusion once a week for~     4 weeks or MabThera® at the same regimen.~   "
142567|NCT01701219|"~     This is a study of safety and efficacy of ceftaroline fosamil in Subjects with Staphylococcus~     aureus Bacteremia or with Methicillin-Resistant Staphylococcus aureus (MRSA) Bacteremia~     persisting after at least 72 hours of vancomycin and/or daptomycin treatment.~   "
142568|NCT01701206|"~     This study seeks to determine whether social networking technologies can be used to increase~     HIV prevention and testing.The HOPE (Harnessing Online Peer Education) model seeks to apply a~     diffusion of innovations style intervention to social media to increase HIV testing.~   "
142569|NCT01701193|"~     The purpose of this study is to determine whether an amino acid is an effective treatment to~     prevent abdominal/pelvic scar tissue.~   "
142570|NCT01701180|"~     Mounting evidence indicates that the intranasal administration of the neuropeptide oxytocin~     has prosocial effects. However, the neural substrates of these effects are still unclear. The~     investigators hypothesized that a single dose administration of oxytocin should increase~     empathogenic and affiliative responses and that these effects are mediated by an increased~     insula activity.~   "
142571|NCT01701167|"~     The purpose of this study will evaluate new technologies that have been included in the new~     PCA-9000A PET/CT System.~   "
142572|NCT01701154|"~     The purpose of the study is to determine if respiratory muscle strength training will be~     beneficial for inspiratory and expiratory muscle strength in adults and children with Pompe~     disease.~   "
142573|NCT01701141|"~     Major depressive disorder (MDD) is often characterized by anhedonia and impaired ability to~     modulate behavior as a function of rewards. However, the neurobiology of anhedonia and~     reduced reward responsiveness remains largely unknown. Because dopamine (DA) plays a critical~     role in goal-directed behavior and reinforcement learning, DA dysregulation might play an~     important role. In fact, several lines of evidence suggest that down-regulation of DA~     transmission might characterize depression vulnerability and the emergence of depressive~     symptoms. The current study seeks to elucidate the role of DA dysfunction in MDD. We~     hypothesize that MDD subjects will show reduced DAT binding potential, reduced reward~     learning in the probabilistic reward task, and abnormal functional magnetic resonance imaging~     (fMRI) activation in dorsal and ventral striatal regions during an instrumental learning~     task.~      This study will include three sessions.~      The first will take place at Massachusetts General Hospital or at McLean Hospital's Center~     for Depression, Anxiety and Stress Research. The aims of this session will be to (a) explain~     the study; (b) collect written informed consent, and (c) assess the subject's eligibility.~      Following this, another session (either second or third in order) will take place at the MGH~     PET Imaging Laboratory. Participants will complete a PET scan and a probabilistic reward task~     designed to measure reward learning and sensitivity to reward. The radioactive tracer~     utilized is 11C-altropane.~      Another session (either second or third in order) will take place at the McLean Hospital~     Neuroimaging Center. Participants will complete an instrumental learning task while in the~     fMRI, followed by a social reinforcement learning task and an implicit learning serial~     reaction time task upon completion of the scan. In the instrumental learning task,~     participants have the opportunity to earn money but need to learn, by trial and error,~     stimulus-outcome associations. The social reinforcement learning task is designed to~     investigate whether learning deficits in MDD are specific to learning from monetary~     incentives or whether the learning deficits are more global and are affected when learning~     from social rewards and punishments. Participants will also complete an implicit learning~     serial reaction time task, designed to exclude the possibility of global learning deficits in~     MDD.~   "
142574|NCT01701128|"~     The project aims to evaluate the effects of 24 weeks of treadmill training (TT), with and~     without a strengthening component, on functional mobility, gait and quality of life in~     patients with Parkinson's disease (PD). The rationale for a study of this type stems from the~     hypothesis that treadmill training may act as an external pacemaker and enhance some~     properties of gait. There is a need for larger scale randomized controlled trials comparing~     the effects of treadmill training to control groups that receive similar amounts of~     attention. To date, no study has combined TT and muscle strengthening, likely the optimal~     form of therapy. A kinesiologist supervises the training, 3 times per week, for a total of 72~     one-hour exercise sessions. It is hypothesized that at the end of 6 months, treadmill~     training will considerably improve walking parameters and the well being of people with PD.~   "
142575|NCT01701115|"~     The purpose of this study is to determine if a decrease in the standard volume of local~     anesthetic used to numb your shoulder area before shoulder arthroscopy will provide adequate~     anesthesia for the procedure and decrease the amount of time until you are ready for~     discharge from the hospital.~   "
142576|NCT01701102|"~     Prolonged motor block and delayed ability to walk are limitations of spinal anesthesia in~     ambulatory (same-day) surgery. This can be improved by lowering the dose of local anesthetic~     (a medication that, when injected around nerves, blocks nerve conduction, resulting in~     numbness and weakness) used in the spine, but too low a dose can result in an incomplete~     block (inadequate anesthesia) in some patients. There is evidence that adding a low dose of~     fentanyl, a narcotic, to mepivacaine enhances the anesthetic effect. The purpose of this~     study is to determine the lowest dose of mepivacaine, a local anesthetic, when combined with~     fentanyl, for which spinal anesthesia is adequate for ambulatory knee arthroscopy.~   "
142577|NCT01701089|"~     This open-label, multiple dose, parallel group study will assess the monoamine oxidase in the~     brain by in vivo positron emission tomography (PET) and safety of RO4602522 in patients with~     Alzheimer disease and in healthy volunteers. Patients and volunteers will receive multiple~     doses of RO4602522 and up to three injections of C11-L-deprenyl-D2 used in the PET.~   "
142578|NCT01701076|"~     Almost all patients with multiple myeloma who survive initial treatment will eventually~     relapse and require further therapy.~      Background: Treatment with lenalidomide and dexamethasone has proven efficacy in two large~     randomized trials (MM-009 and MM-010) leading to a time to progression (TTP) of 17.1 months~     for patients with only one prior therapy and a TTP of 10.6 months for 2 and more prior~     therapies, respectively [1-3]. Continuous treatment with lenalidomide and dexamethasone until~     disease progression is therefore considered a standard therapy for second line treatment in~     multiple myeloma patients. However, only a relatively low rate of high quality response (CR,~     complete response and VGPR, very good partial response) is achieved. High quality responses~     are associated with with improved progression-free survival and overall survival [4].~      Trial: The aim of this trial is to improve high quality response rates for patients with~     relapsed or refractory multiple myeloma in the 2nd line treatment. This aim shall be achieved~     by the addition a third anti-myeloma drug (bendamustine) to the established backbone of~     lenalidomide/ dexamethasone.~      Treatment regimen:~        -  Induction Treatment Phase: Cycles 1-6 Bendamustine 75mg/m2/d day 1 and 2, lenalidomide~          25mg/d 1-21, dexamethasone 40mg / 20mg (for patients > 75years) d 1, 8, 15, 22.~        -  Maintenance Treatment Phase: Cycles 7-18 lenalidomide 25mg/d 1-21, dexamethasone 40mg /~          20mg (for patients > 75 years) d 1, 8, 15, 22.~      Due to hematoxicity of bendamustine and lenalidomide, administration of pegfilgrastim is~     mandatory in the induction treatment phase (BRd-regimen)for all patients experiencing severe~     neutropenia.~      The aim of this study is to achieve high quality response rates (CR, VGPR) of ≥ 40%. If this~     aim is achieved, the treatment of bendamustine in combination with the established~     lenalidomide/ dexamethasone regimen will be considered promising.~      Besides efficacy, the safety of this three-drug regimen is evaluated in this trial.~   "
142579|NCT01701063|"~     The purpose of this study is to assess the safety, efficacy, and pharmacokinetics in a~     carefully monitored cohort of pediatric subjects infected with hepatitis C virus (HCV) on a~     telaprevir-based regimen in Part A and with dose adjustments if needed before Part B.~   "
142580|NCT01701050|"~     Utilizing CellSearch® technology, the ability to both enumerate and reliably and reproducibly~     characterize circulating tumor cells (CTC) for tumor markers that predict endocrine~     sensitivity (estrogen receptor [ER] and Bcl-2) and resistance (HER2 and Ki67) has been~     demonstrated. An algorithm for a CTC-Endocrine Therapy Index (CTC-ETI) has been constructed~     that can be calculated for each patient using the CTC enumeration and marker results. The~     primary goal of this study is to determine a CTC-ETI in ER positive, HER2 negative metastatic~     breast cancer patients before the initiation of a new endocrine therapy for the~     identification of patients that will progress rapidly.~   "
142581|NCT01701037|"~     This phase II trial studies how well giving dabrafenib alone and in combination with~     trametinib before surgery works in treating patients with advanced melanoma that can be~     removed by surgery. Studying samples of tumor tissue in the laboratory from patients~     receiving dabrafenib and trametinib may help doctors learn more about the effects of these~     drugs on cells and help identify biomarkers that determine which patients will respond to~     these drugs best.~   "
142582|NCT01701024|"~     The primary objective of this study is to compare the efficacy and safety and tolerability of~     ACYC Gel and vehicle in the treatment of subjects with Acne Vulgaris.~   "
142675|NCT01699802|"~     The purpose is to investigate how the adsorptive capacity of the active carbon filter to~     carbon dioxide in an anaesthetic gas reflector (AnaConDa) is affected by adding inhaled~     anaesthetic agent.~      The hypothesis is that addition of inhaled anaesthetic agent will affect the amount of~     adsorption of carbon dioxide to the active carbon and thereby affect rebreathing of carbon~     dioxide.~   "
142583|NCT01701011|"~     Background of the study:~      Undergoing an IVF or ICSI treatment is an emotional and physical burden for both the woman~     and her partner. Most stressful for the couple is waiting for the result of the treatment,~     the period after the embryotransfer until the pregnancy test or menstruation and an~     unsuccessful treatment. Symptoms of anxiety and depression have been identified in couples~     during the waitingperiod after an embryotransfer. For this waitingperiod a short selfhelp~     copingintervention has been developed based on the stress theory of Lazarus for women to use~     at home. Goal of the instrument is to stimulate the copingstyle positive reappraisal.~     Research has demonstrated that using this copingstyle can have a positive impact in health~     related circumstances.~   "
142584|NCT01700998|"~     Acute renal failure (ARF) is a serious and common complication in hospitalized patients,~     occurring in more than 25% of intensive care unit (ICU) patients. Hypomagnesemia is a common~     disorder, occurring in approximately 12% of hospitalized patients, with an incidence of 60%~     in ICU patients. The majority of those patients have are asymptomatic hypomagnesemia, and~     patients with mild hypomagnesemia do not need treatment, only the correction of the~     underlying cause. Hypomagnesemia potentiates postischemic renal failure in rats, and is~     associated, in humans, with acute renal failure. To date, there is no study that demonstrated~     a benefit of maintain normal levels of magnesium in the incidence of ARF in critically ill~     patients. Thus, we suggest that a treatment aimed to maintain normal magnesium levels during~     ICU stay can decrease the incidence of ARF. We will perform a randomized clinical trial that~     will include all patients admitted to an ICU that, develop hypomagnesemia. It will be~     excluded from the study: patients younger than 18 years, participants from other studies,~     pregnant women, patients with creatinine greater than or equal to 3.5 mg / dl or on dialysis,~     patients who used intravenous contrast for radiological studies, patients weighing less than~     40kg, suffering from advanced malignant disease, with severe hypomagnesemia (serum magnesium~     less than or equal to 1.1 mg / dl), with a diagnosis of Torsades de Pointes or symptomatic~     hypomagnesemia prior to randomization. Patients included in the study will be randomized to~     one of the following groups: placebo (saline solution 0.9%) or 50% Magnesium Sulfate.~     Patients will receive an administration of 48 mEq Magnesium diluted in 250 ml saline 0.9% for~     24 hours in an infusion rate of 10.4 ml / hr. Therapy will be continued for 3 days, and~     repeated during ICU stay to maintain magnesium levels in the normal range. Placebo group will~     receive exactly the same infusion only with saline administration. The therapy will be~     discontinued if the patient has hypermagnesemia or signs of magnesium intoxication. The main~     outcome measurement will be the occurrence of ARF during ICU stay.~   "
142585|NCT01700985|"~     Corticosteroids are one of the mainstays of treatment for subjects with~     corticosteroid-responsive dermatoses such as psoriasis. This study has been designed to~     determine and compare the efficacy and safety of a formulation of 122-0551 versus the~     corresponding Vehicle in subjects with stable plaque psoriasis after twice daily dosing for~     14 consecutive days.~   "
142586|NCT01700972|"~     The current protocol for myocardial perfusion imaging (MPI) entails imaging within 30-45~     minutes after radiotracer injection, for both rest and stress studies. We hypothesize that~     early imaging 10 minutes after radiotracer injection provides high image quality and~     diagnostic accuracy comparable to 30-45 minutes MPI.~   "
142587|NCT01700959|"~     Primary objective:~        1. To examine the efficacy of melatonin treatment on neurocognitive functioning in adult~          survivors of childhood cancer.~      Secondary objectives:~        1. To evaluate the efficacy of melatonin treatment on delayed sleep onset latency in~          long-term childhood cancer survivors.~        2. To investigate whether improvement in sleep onset latency due to melatonin treatment is~          associated with neurocognitive improvement in long-term childhood cancer survivors.~      This study is a randomized double-blind placebo controlled trial of time release melatonin~     for adult survivors of childhood cancer who demonstrate impaired neurocognitive functioning~     and/or difficulty falling asleep.~   "
142588|NCT01700946|"~     The overall objective of this protocol is to improve the cure rate of relapsed precursor~     B-cell acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma.~      This phase II trial is studying risk-directed therapy for B-lymphoblastic leukemia or~     lymphoma in first relapse. Standard risk (SR) and high risk (HR) participants will receive~     different therapy. Treatment will consist of chemotherapy for SR participants, and~     chemotherapy followed by hematopoietic stem cell transplant (HSCT) for HR in first relapse.~     Induction therapy consists of three blocks of chemotherapy. The first block is a novel~     immunotherapy regimen that includes chemotherapy, rituximab and infusion of haploidentical~     natural killer (NK) cells. SR participants will continue to receive chemotherapy for a total~     duration of approximately 2 years. HR participants will be candidates for HSCT and will~     proceed to transplant once a suitable donor is found and their minimal residual disease (MRD)~     is negative.~   "
142589|NCT01700933|"~     Osteoarthritis is a common disease that causes muscle weakness, stiffness and instability.~     The disease reduces the opportunities for an active lifestyle. Exercise Therapy provides a~     well-documented effect on pain and function in patients with osteoarthritis of the hip. It is~     sought an optimal dose of exercise, in which this study will help to investigate.~      We hypothesize that an exercise program designed to have a high number of repetitions will~     benefit the outcome of the training in a more positive way than a low-repetition based~     program.~   "
142590|NCT01700920|"~     The purpose of this study is to analyze the safety and feasibility of direct administration~     intrafemoral mesenchymal stem cells (MSCs) in vitro expanded autologous treatment of patients~     with femoral osteonecrosis.~   "
142591|NCT01700907|"~     Various issues had been pointed out when undergoing the anesthesia for elderly patients with~     sevoflurane, such as delayed emergence, post-operative trouble with swallowing.~      Desflurane, which has a lower blood/gas partition coefficient, is expected to contribute the~     better emergence, along with the recent progress on optimization of delivered amount of~     anesthesia.~      The purpose of this study is to compare the time to emergence in long elderly patient cases~     with desflurane or sevoflurane, with the recently developed drug-delivery optimization system~     Aisys® (GE Healthcare Japan).~   "
142592|NCT01700894|"~     African American (AA) women have the lowest physical activity (PA) levels, which contributes~     to substantial disparities in cardiovascular health and depressive symptoms. There is a need~     to examine ways to promote PA that are appealing, applicable to clinical practice, and~     cost-effective. The purpose of this clinical trial is to test the efficacy of the Women's~     Walking Program (WWP), consisting of a lifestyle PA prescription and group visit delivery~     model, with or without tailored telephone contacts between group visits for increasing~     adherence to PA and improving health outcomes. Two telephone contact strategies will be~     compared against a no-telephone control condition: a person-administered contact strategy~     using brief motivational interviewing and an automated contact strategy using a telephone~     computer-linked system. Group visits and telephone contacts are designed to increase~     adherence to lifestyle PA with an emphasis on accumulation of 3,000 steps daily over~     baseline. The aims of this study are (1) to compare the initial (adoption 24 weeks) and~     longer-term (maintenance 2nd 24 weeks) effectiveness of the WWP plus person-administered~     telephone contacts, WWP plus automated telephone contacts, and the WWP without telephone~     contacts on (a) increasing adherence to lifestyle PA, (b) improving health outcomes (aerobic~     fitness, body composition, depressive symptoms), (c) improving self-efficacy (confidence in~     one's ability to be physically active) and outcome expectations (expected benefits to being~     more active); and (2) to compare cost-effectiveness of the three telephone treatment~     conditions in relation to adherence to lifestyle PA and health outcomes.~      The investigators will randomly assignment of the order of administering the three conditions~     to six community health care sites. These six sites are similar with respect to race,~     socioeconomic status, and residential mobility. The study will include 288 sedentary AA women~     aged 40 to 65 years who have no major signs or symptoms of cardiovascular disease (CVD); no~     history of myocardial infarction, stroke, or diabetics with elevated HgA1c; BP < 160/100.~      Initial screening will occur in person or over the phone. Further screening at the data~     collection site with an advanced practice nurse will include blood work for glucose and~     lipoproteins, a history and physical, and resting EKG. At baseline, 24 and 48 weeks all women~     who are eligible will: be given questionnaires on physical activity, health and factors that~     influence their physical activity; have their height, weight, waist circumference measured;~     and do a two minute step test. All three treatment group will attend 5 group visits every 5~     weeks during adoption (first 24 weeks) and 1 booster group visit during maintenance (week~     36). The group visit consists of brief individual time with a staff member followed by a~     group visit with motivational videotapes. All treatment groups will self-monitor their~     physical activity with accelerometers and enter their step data into a voice response system.~      The groups receiving the automated telephone contact strategy and the group receiving the~     person telephone contact strategy will have the same number and spacing of the telephone~     contacts (nine 10- to 15-minute telephone contacts delivered every two to three weeks between~     group visits during adoption and two telephone contacts [weeks 28, 43] during maintenance).~     Using motivational interviewing, a nurse will tailor the telephone discussion to the person~     telephone contact group to match the participant's needs, experiences, barriers, motivation,~     and confidence. Women in the automated telephone contact group will receive an automated call~     with feedback on their progress based on the information they reported into the ATCL system.~     The automated telephone contact system will deliver feedback on progress, problem solving,~     goal-setting, and support. All information will be delivered in the voice of one of our staff~     members. The third treatment group will receive no telephone contacts between group visits.~      Potential risks exist for women who have medical problems, which contraindicate physical~     exercise. Additional risks associated with the walking program include safety and injury.~     There are potential risks of infection at the site of the one time finger blood withdrawal.~     Potential benefits to subjects include improved aerobic fitness, blood cholesterol, body~     composition and blood pressure and fewer symptoms. The subjects will be given a physical~     activity prescription that should benefit them through life and decrease their risk for CVD.~      Women will be recruited throughout the West and South side of Chicago. They will give verbal~     consent at the screening questionnaire and sign an informed consent at the time of the~     screening history and physical. They will be told that participation is voluntary, they may~     decline or withdraw at will at any time, and all results will be held strictly confidential.~   "
142593|NCT01700881|"~     The purpose of the study is to assess whether, in individuals with rheumatoid arthritis, a~     low-fat, vegan diet improves pain and other subjective symptoms more effectively than a~     control supplement or a placebo. The principal measure is pain as measured by Visual Analog~     Scale (VAS) and disease activity as measured by number of painful swollen and tender joints,~     respectively. The study duration is 36 weeks.~      This study tests that a low fat, plant-based (vegan) diet free of foods commonly identified~     as triggers improves mood, using the Center for Epidemiologic Studies Depression~     Scale-Revised (CESD-R), and the Beck Depression Inventory II (BDI-II).~   "
142701|NCT01699464|"~     A double-masked, parallel study of AR-12286 Ophthalmic Solution 0.5%, or 0.7% (q.d., PM) or~     timolol maleate Ophthalmic Solution, 0.5% (b.i.d.), O.U. for 3 months.~   "
142594|NCT01700868|"~     This study aims to test hypotheses that are potentially important to diabetes management,~     with practical implications for reducing the medical, personal, and economic costs of the~     disease. Anticipated outcomes include reductions in glycosylated hemoglobin that are~     significantly greater than those achievable with current diet recommendations, reductions in~     medication use among many intervention-group participants, beneficial changes in body weight~     and serum lipid concentrations, and a demonstration of the acceptability of the intervention~     diet. Progress toward these goals could refine dietary guidance for individuals with~     diabetes, increase treatment expectations, and reduce the massive burden the disease~     currently imposes.~      The study further attempts to translate a dietary intervention studied in a clinical research~     setting to a medical practice. This will contribute to developing a model for diabetes care~     that can be used widely.~   "
142595|NCT01700855|"~     The purpose of this study is to verify the intraoperative analgesia of electroacupuncture in~     patients undergoing selective nasal sinus surgery and mammaplasty.~   "
142596|NCT01700842|"~     Approximately 3,000 of clinically significant isolates of different species from respective~     respective sources in geographically distinct Russian cities will be collected and tested on~     ceftaroline and other antimicrobials.~   "
142597|NCT01700829|"~     This study is designed to compare the effectiveness of two medications, Ketamine and~     Midazolam, for rapidly relieving suicidal thoughts in people suffering from depression.~      The first drug, Ketamine, is an experimental antidepressant that early studies have shown may~     quickly reduce suicidal thoughts, but we are not sure how well it may work. Midazolam, the~     comparison drug, is not thought to reduce depression or suicidal thoughts.~   "
142598|NCT01700816|"~     The purpose of this study is to find out if using bright light sessions during bone marrow~     transplant can prevent people from developing confusion also known as delirium.~   "
142599|NCT01700803|"~     The aim of this randomized clinical trial is to compare the efficiency of hand scrubbing by~     Povidone-Iodine solution 10% over 7.5% concentration in decreasing post-cesarean section~     wound infections & compare side effects of both agents.~   "
142600|NCT01700790|"~     The object of this study is to evaluate the pharmacokinetic interactions, short term safety~     and efficacy of standard dose lopinavir/ritonavir 200mg/50 (two tablets twice daily) given~     with ritonavir 100 mg three tablets twice daily given in combination with rifampin in~     HIV-infected persons with tuberculosis~   "
142601|NCT01700777|"~     A randomized control trial of HABIT-ILE therapy compared with regular / conventional~     intervention (same amount of hours). The protocols have been developed on the basis of~     bimanual therapy (HABIT) developed at Columbia University.~   "
142602|NCT01700751|"~     This pilot clinical trial studies the safety and maximum tolerated dose of brentuximab~     vedotin when given with tacrolimus and methotrexate after unrelated allogeneic donor stem~     cell transplant in patients with acute myeloid leukemia, acute lymphoblastic leukemia, or~     myelodysplastic syndromes. The addition of brentuximab vedotin to tacrolimus and methotrexate~     may result in a significant reduction of graft versus host disease in these patients.~   "
142603|NCT01700738|"~     MAIN OBJECTIVE To compare the effects of the placement of an adjustable gastric band with~     conventional treatment of obesity.~      SECONDARY OBJECTIVES~        -  Compare the effects of the placement of a gastric band with conventional treatment of~          obesity on quality of life, body composition and parameters of the metabolic syndrome.~        -  Identify predictors of good answer to the ring to determine the best future~          indications.~        -  Study of the gastric tolerance.~      INCLUSION CRITERIA~        1. Adolescents 12 to 16 years and with BMI and weight gain according to sex and age is~          greater than IMCZ-score > 4 DP> 8 kg~        2. Obesity common non-syndromic.~        3. Medical decision of surgical placement of laparoscopic gastric banding.~        4. Adolescent and family who understand and accept the need for medical and surgical follow~          long term.~        5. Adolescent and family who fully understood the oral and written information explaining~          the study and the need for prolonged follow-up.~        6. Obtention of oral and written consent of the adolescent and the parents.~        7. Parents and adolescents affiliated with the social security system.~      NONINCLUSION CRITERIA~        1. Intellectual Deficit.~        2. psychiatrics contraindication of surgical placement of laparoscopic gastric banding.~        3. Obesity with severe binge eating.~        4. Pregnancy or wishes of pregnancy in the following year.~        5. Non accession adolescent and / or family in the process of medical care before~          inclusion.~        6. Predictable post surgical monitoring difficulties.~        7. Suspicion of physical abuse, verbal or negligence / deficiency in care of the family.~        8. Participation in a clinical study evaluating a treatment during the 2 years of the~          study.~      EXCLUSION CRITERIA~        1. Anesthetic contre indication for placement of a gastric laparoscopic.~        2. IMC> 50 kg/m2 the day of inclusion.~      STRATEGIES / PROCEDURES During a routine visit, the study will be presented to the patient~     and his family. Patients will then be enrolled and randomized. Patients in group A (surgery~     group) will follow the usual multidisciplinary bariatric surgery in adolescents. Patients in~     group B start conventional monitoring dietary medical and physical. For both groups follow-up~     visits will occur every 3 months for 2 years.~   "
142604|NCT01700725|"~     The purpose of this study is to determine whether nasal irrigation with Xylitol or saline are~     effective in the treatment of chronic rhinosinusitis and fatigue symptoms associated with~     Gulf War Illness.~   "
142605|NCT01700712|"~     The increasing interest in probiotic lactobacilli in health maintenance has raised the~     question of potential risks. One possible side effect could be an increased acidogenicity in~     dental plaque. The aim of this study was to investigate the effect of probiotic lactobacilli~     on plaque lactic acid (LA) production in vitro and in vivo.~      Methods. subjects (n=18) were given lozenges with probiotic lactobacilli (L. reuteri DSM~     17938 and ATCC PTA 5289) or placebo for two weeks in a double-blinded, randomized cross-over~     trial. The concentration of LA in supragingival plaque samples was determined at baseline and~     after 2 weeks. Salivary counts of mutans streptococci (MS) and lactobacilli were estimated~     with chair-side methods.~   "
142612|NCT01700621|"~     The investigators aim to establish the non-inferiority of concomitant administration of~     measles-rubella and rotavirus vaccines to measles-rubella vaccine given alone in terms of~     measles seroconversion rates. The primary study hypothesis is the measles seroconversion rate~     as defined by the percentage of children seroconverting to measles with a measles serum~     antibody concentration of >=1:120 at 8 weeks post vaccination after the concomitant~     administration of measles-rubella and rotavirus vaccines is non-inferior to that obtained~     when measles-rubella vaccine is given alone in children 9 months of age who have received a~     primary rotavirus vaccine series with the first dose between 6 and 10 weeks and the second at~     least 4 weeks later and are seronegative for measles antibody in the pre-vaccination sample.~   "
142742|NCT01698931|"~     This trial is conducted in Europe. The aim of this trial is to compare the efficacy of~     repaglinide to glyburide and placebo on hepatic glucose metabolism in subjects with type 2~     diabetes.~   "
142849|NCT01697501|"~     This cross-sectional multicenter study will evaluate the IL28B polymorphism in patients with~     HBeAg-negative chronic hepatitis B treated with Pegasys (peginterferon alfa-2a) in the~     predecessor ML18253 study. The study consists of a single visit where eligible patients will~     undergo a blood test for IL28B genotyping, with a phone follow-up 7 days after the visit.~   "
142606|NCT01700699|"~     -  Background: BRAFV600E is the most frequent oncogene in differentiated thyroid cancer~          (DTC) occurring in about 50% of cases. Clinical trials with tyrosine kinase inhibitors~          (TKI) with specific activity against BRAF in metastatic radioiodine-resistant DTC~          (MRR-DTC) are ongoing. Very recently it has been demonstrated that DTC often consists of~          a mixture of tumor cells with wild-type and mutant BRAF. The subclonal occurrence of~          BRAFV600E in MRR-DTC could disable the therapy with BRAF targeted TKI and be responsible~          of the frequent defeats of this treatment. A therapeutic strategy based upon BRAF~          inhibitors in tumors bearing subclonal BRAFV600E could be initially successful hitting~          the tumor cells expressing the oncogene, and after the initial tumor growth arrest~          and/or shrinkage, the oncogene negative cells insensitive or less sensitive to the~          treatment, could restart the growth of the tumor causing the progression of the disease~          and the escape from the clinical response.~        -  Aims: To determine the impact of subclonal BRAFV600E on the efficacy of BRAF inhibitors~          in the treatment of MRR-DTC.~        -  Study design: Primary tumor tissues will be analyzed for the presence of BRAFV600E by~          pyrosequencing or other quantitative assay. If available, synchronous metastases and~          post-therapy metachronous metastases will be analyzed as well. The clinical response~          will be determined according to RECIST, and the association with the percentage of~          BRAFV600E alleles will be evaluated. Attention will be paid to the possible difference~          of BRAFwild-type/BRAFV600E ratio between primary tumors and synchronous metastases,~          primary tumors and post-therapy metachronous metastases, and between responsive and~          resistant synchronous tumor lesions.~   "
142607|NCT01700686|"~     The overall purpose is to explore the link between the gut and the bones by investigating~     meal stimulated changes in the blood level of a number of hormones and markers related to~     intestinal growth and bone turnover in patients undergoing surgery for obesity (gastric~     bypass). The hormones will be measured in blood samples taken before and after surgery. The~     results are compared with changes in body weight and body composition as measured by DEXA~     scanning.~   "
142608|NCT01700673|"~     To determine the impact of maintenance therapy in patients with MDS/AML in remission.~   "
142609|NCT01700660|"~     Major liver surgery often requires the surgeon to temporarily halt the afferent blood flow in~     order to prevent excessive blood loss. However, this predisposes the liver to a detrimental~     inflammatory response once the circulation is restored. Altogether, the effects that result~     from this temporary withdrawal of blood are known as ischemia and reperfusion (I/R) injury,~     and the extent to which this occurs determines the functional outcome of the liver after~     surgery.~      Recently, it has become clear that (over)activation of the immune system forms the mainstay~     of I/R injury in the liver. More importantly, it has been shown in animal models that~     self-antigens, which are normal cellular constituents that become immunogenic mediators~     following their release from dying cells, are involved in the earliest stages of I/R injury~     of the liver. Clinical data on the release self-antigens in I/R injury are however scarce to~     date. Therefore, the aim of this study is to investigate the release of self-antigens in~     patients that undergo a major liver resection with or without withdrawal of the liver's blood~     flow. Also, the results will be correlated to genes involved in the inflammatory response as~     well as clinical parameters for liver damage and function.~   "
142610|NCT01700647|"~     It is possible to test a sample of breath from a patient, run it through a machine, and find~     out certain diseases in the patient without needing to do Xrays. It is sort of like~     abreathalyser.In the future it is hoped this type of testing will be common, and allow~     certain conditions to be picked up early. One of these conditions is Cancer of the Larynx~     (voice box). It is not in wide use yet however a study has shown it is very effective in~     detecting Larynx cancer.~      This breath test has detected cancers at a stage when they CAN be seen on Xrays or looking in~     with cameras. However the larger the cancer ultimately the worse it is for the patient. It~     would therefore be much better to have the breath test find patients with cancers at a much~     smaller size. It is interesting that the cancers which the breath test HAVE found all have~     the same breath test signal, regardless of size. This means even smaller cancers may have the~     same signal. These small cancers are only 1-2 mm thick, and when found at this size almost~     all can be cured. We want to find a group of patients who have these early cancers and~     compare it to breath test result in patients who have large obvious cancers. These patients~     will be compared to other patients who have are negative for larynx cancer who also have a~     breath test. We want to prove that their breath test will be negative.~      You have been referred either because you have symptoms (such as cough or hoarse voice) and~     need a scope to look into the airways, OR your specialist has identified a spot on the larynx~     which needs a biopsy (sample) and then possible treatment, The spot may or may not be cancer-~     that is why the biopsy is needed. After that the correct treatment would be considered~     depending on the result, that is, whether it is a cancer or not. If possible we would like to~     take a test of your breath before the biopsy. Alternatively we can take a breath test 2 weeks~     after a biopsy.~      In summary this study is trying to show whether the breath test is the same in patients who~     have large cancers as patients with small cancers invisible on XRay and only found with~     careful magnification by scopes looking in. If we can show these findings it will demonstrate~     great potential for the breath test to find many more cancers which are truly curable.~   "
142611|NCT01700634|"~     The aim of this project is to investigate fMRI ability to identify pain central sensitization~     in chronic knee OA. Patients with high and low central sensitization and healthy control~     subjects will be included. Central sensitization will be clinically defined based on the~     evidence of regional spread of pain (spreading sensitization) and increased pain response to~     repeated stimulation (temporal summation). Operatively, a patient will be assigned to high~     sensitization group when showing (i) clinical evidence of pain or altered sensations spread~     beyond the knee joint by manual palpation, (ii) a minimum of 3 anatomical sites around the~     knee showing a pressure pain threshold below 4 kg/cm2 (tender points), (iii) pain score of 4~     points or more in a 11-point scale during 4 kg/cm2 pressure stimulation on the~     anterior/medial surface of the tibial bone (the site selected for the fMRI experiment) and~     (iv) increase of at least 1 point in a 11-point scale after 10 repeated pressure stimulation~     on the tenderest point around the knee.~      A three-step strategy is proposed to characterize the phenomenon by assessing (i) brain~     response to direct pressure stimulation on the painful knee, which will reflect the~     combination of peripheral and central sensitization; (ii) brain response to pressure~     stimulation on a non-arthritic hyperalgesic area (i.e., the anterior surface of the tibia),~     which will mostly reflect central sensitization mediated at the spinal cord level, and (iii)~     brain response to moderately painful heat stimulation on a healthy skin area (i.e., volar~     forearm), which will reflect central sensitization occurring in the brain and involving the~     highest-level pain modulatory mechanisms. An additional evaluation is proposed using~     resting-state fMRI to assess potential alterations in baseline brain functional organization.~   "
142623|NCT01700478|"~     This study was done to determine if the use of a combination of preoperative rectal~     misoprostol 400µg used with intraoperative perivascular vasopressin is better than~     perivascular vasopressin used alone to decrease bleeding at myomectomy.~   "
142613|NCT01700608|"~     Plerixafor is a new CXCR4 inhibitor that is able to improve peripheral blood stem cell (PBSC)~     mobilization when combined with granulocyte-colony-stimulating factor (G-CSF). The 'on~     demand' use of plerixafor at the hematopoietic recovery after chemotherapy + G-CSF may be~     more efficient and cost-effective, but the timing of administration and criteria for patient~     selection are still under investigation. We collected the data of lymphoma and myeloma~     patients treated with plerixafor at the hematopoietic recovery after chemotherapy + G-CSF.~     The decision of adding plerixafor was based on PB CD34+ cells at the time of hematopoietic~     recovery after chemotherapy in patients at their first or subsequent attempt, according to~     the attending physician choice. The primary endpoint was the assessment of the rate of~     patients who were able to collect >=2 x 10^6 CD34+/kg.~   "
142614|NCT01700595|"~     Contractures and broad scars of the axilla, anterior chest wall and neck have detrimental~     effects on functional, physical and psychological development of children. Perforator flaps~     have already been shown to be reliable options for the reconstruction of contractures but~     there have been no reports demonstrating the value of preexpanded perforator flaps of~     dorsolateral trunk region in treatment of extensive contractures and scars of pediatric~     patients. The purpose of this study is to demonstrate these techniques by a case series~     formed of pediatric patients with broad scars and contractures of anterior chest wall,~     axilla, neck and breasts. Seven pediatric patients (mean age, 11,6 years) who were treated by~     preexpanded perforator flaps are presented. By this means, clinical experience on intercostal~     artery perforator (ICAP) flap, thoracodorsal artery perforator (TDAP) flap, circumflex~     scapular artery perforator (CSAP) flap and lumbar artery perforator flap was shared. Flaps as~     large as 20,5x10,5 cm in size could be successfully transferred in pediatric patients. Broad~     scar tissues were resurfaced with broad flaps carrying similar characteristics with the~     uninjured anterior chest wall and neck skin in six of our patients. In one patient with~     partial necrosis, full thickness skin graft was used for the residual defect. The mean~     duration of postoperative (after flap transfer) follow-ups was 17,2 months. The preexpanded~     TDAP, ICAP and CSAP flaps are revealed to be useful reconstructive options for the treatment~     of scars and contractures of anterior chest wall, axilla, neck and breast in pediatric~     patients.~   "
142615|NCT01700582|"~     The French National Cancer Institute (INCa) support a 28 hospital platforms network for~     molecular testing of cancer patients. These platforms routinely assess a panel of biomarkers~     in order to speed up access of French cancer patients to targeted therapies (commercially~     available or through clinical trials).~      The objective of the BIOMARKERS-France study is to describe the epidemiological, clinical and~     molecular characteristics of these patients and their tumors and to assess the impact of~     these analyzes on their treatment (ie bio-guided therapy) as well as outcomes (response rate,~     progression free and overall survival).~   "
142616|NCT01700569|"~     O6-méthylguanine méthyltransférase (MGMT) is the main repair gene after DNA lesion induced by~     Temozolomide in combination with radiation therapy of Glioblastoma (GBM) in Stupp.R et al~     published regimen. In preclinical models, it has been demonstrated that MGMT methylation~     (which is silencing the DNA repair process) is achievable by folic acid. About half of the~     patients with operated GBM have an un-methylated MGMT gene status and therefore a poorer~     prognosis. A phase-1 dose escalation study is proposed with pharmacologic doses of folinic~     acid in combination with temozolomide and radiotherapy of operated GBM.~   "
142617|NCT01700556|"~     The UP-TECH project aims at developing an UPgrading quality of care for Alzheimer's disease~     patients through the integration of services and the use of new TECHnologies in order to also~     improving the quality of life of their family caregivers.~   "
142618|NCT01700543|"~     This post market clinical follow-up study is designed to confirm safety and performance of~     the Sidus Stem-Free Shoulder when used in hemi or total shoulder arthroplasty.~      The safety of the implant will be evaluated by monitoring the frequency and incidence of all~     kinds of adverse events.~      The performance will be determined by analyzing the implant survival, overall pain and~     functional performances (based on Constant & Murley score and ASES score), subject quality of~     life (EuroQol EQ5D) and radiographic parameters (e.g. radiolucencies, osteolysis, component~     migration) of study subjects who received the Sidus Stem-Free Shoulder.~      The Sidus Stem-Free Shoulder is not approved for use in the US.~   "
142619|NCT01700530|"~     Here we tested if statins or exercise plus statins had a greater capacity to lower metabolic~     syndrome risk factors in sedentary individuals with at least 2 metabolic syndrome risk~     factors. We also examined if statins impacted exercise response for mitochondrial content in~     muscle or aerobic fitness.~   "
142620|NCT01700517|"~     Total knee arthroplasty (TKA) is a worldwide realized procedure, with 600.000 surgeries~     performed per year in the United States, with a 673% increase estimated until 2030.~     Functional and pain management improvement is expected in 90% of patients, with 85% of them~     satisfied after the procedure.~      Immediate postoperatory pain control is an important aspect to be considered. Patients~     submitted to TKA endure pain with variations between 40-80 (according to analog visual scale~     -AVS - which goes from zero to 100) during the immediate postoperatory, with slow decline in~     the first 24 hours. Pain classified as severe occurs in 60% and moderated in 30% of patients~     submitted to TKA during this period of time. Therefore adequate pain management allows an~     earlier rehabilitation, with a higher satisfaction rate and decrease the hospitalization~     period.~      A multimodal control of pain can be reached by using non-steroidal anti-inflammatory, COX-2~     anti-inflammatory inhibitors, peripheral nerve blocks and intra-articular anesthetics~     injections and decrease use of opioids given of potential collateral effects. Peripheral~     blockings are associated to the smallest rate of collateral effects and complications when~     compared to the spinal anesthesia and analgesia controlled by the patients. Studies comparing~     the effects of the femoral and sciatic-femoral blocking guided by ultrasonography for the~     analgesia control after TKA were not found.~      The objective of this article is to evaluate the effect of femoral and sciatic-femoral block~     using ultrasonography by the analog visual scale (AVS) of pain in postoperatory of patients~     submitted to TKA, opioid consumption and complications associated to anesthesics procedures.~   "
142621|NCT01700504|"~     The effect of axillary lavage with a gentamicin solution before wound closure will reduce the~     drainage volume and subsequently day of drainage removal.~   "
142622|NCT01700491|"~     Paravertebral analgesia is non-inferior to epidural analgesia for pain control and superior~     to epidural analgesia in terms of the main complication of hypotension.~   "
142624|NCT01700465|"~     Machine learning techniques and algorithms originally developed for use in the field of~     robotics can be applied to continuous, noninvasive physiological waveform data to discover~     hidden, hemodynamic relationships. Newly developed algorithms can, in real-time: 1) estimate~     acute blood loss volume, 2) monitor and estimate fluid resuscitation needs, 3) predict~     cardiovascular collapse well ahead of any clinically significant changes in standard vital~     signs, and 4) estimate intracranial pressure. We hypothesize that these same methods can be~     used to monitor volume loss during hemodialysis, as well as predict intradialytic~     hypotension, well before it occurs.~   "
142625|NCT01700452|"~     Early detection of lung cancer and early removal of the cancer nodules facilitates the~     diagnosis and treatment. However, not all nodules are malignant. Currently the standard~     method to diagnose lung cancer is to remove any suspicious nodules from the lung in a~     surgical procedure.~      This study is being conducted to evaluate the performance of a laboratory test to detect~     changes in lung cells that might be an early indicator of lung cancer. The test uses mucus~     (sputum) which is collected in a non-invasive method. This study will compare the results of~     the lung biopsy with the laboratory test to determine if the test can detect cancer or the~     lack of cancer.~      The laboratory test will not be shared with the treating physician or the patient as the~     current standard for lung cancer diagnosis is a biopsy. Approximately 330 patients will be~     enrolled in the study. There is one visit involved and includes the collection of a sputum~     specimen by coughing into a cup. The medical records of patients who are negative for cancer~     by biopsy will be reviewed for 2 years to detect any changes in diagnosis.~   "
142626|NCT01700439|"~     The purpose of the clinical study is to prove that the heart valve device is safe, effective,~     and performs as intended.~   "
142627|NCT01700426|"~     The study addresses treatment of iron deficiency, the most common nutritional deficiency that~     infants and young children encounter. With the knowledge that iron deficiency may~     irreversibly affect a baby's long-term neurodevelopment and behavior, the investigators are~     offering free screening blood draws at Children's Hospital Colorado to older babies and~     toddlers (9-24 months old). If their blood results indicate a serum ferritin of ≤ 15~     micrograms/dL without the presence of an elevated C-reactive protein (CRP), they will be~     invited to continue in the intervention portion of the study, where they will receive iron~     supplements as well as vitamin E (or placebo) for an eight week treatment period. The~     rationale for the study is to test whether addition of Vitamin E, an antioxidant and~     anti-inflammatory agent, improves the treatment response to supplemental iron.~   "
142628|NCT01700413|"~     While several studies have been reported with increasing doses of daunorubicin in the first~     line treatment of Acute Myeloid Leukemia (AML), there is no similar experience with~     idarubicin as initial treatment of AML.~      As idarubicin is the most common treatment used for AML, it is needed to find the optimal~     dose for the combination of idarubicin, cytarabine and G_CSF, to explore if this combination~     improves the outcomes of current treatments for AML.~      The aim of this dose-finding study is to find the optimal dose for the combination of~     idarubicin, cytarabine and G-CSF that could improve the response rate, reduce relapse and~     improve survival of patients with primary acute myeloid leukemia. This could be a significant~     advance in a field where treatment outcomes have stabilized in the last 15 years. This study~     will be the basis for further prospective, randomized, multicenter trial comparing idarubicin~     maximum tolerated dose, compared to standard treatment with idarubicin and cytarabine,~     including raising both arms in G-CSF. The dose of 12 mg/m2 will be administered as control~     arm in this future randomized study, which will investigate the benefit of enhanced dose~     identified as optimal in this phase II pilot study.~   "
142629|NCT01700400|"~     The purpose of this study is to determine whether the investigational study drug everolimus~     may be used to increase the effectiveness of chemotherapy treatment for patients with~     advanced lung cancer.~   "
142630|NCT01700387|"~     The purpose of this study is to evaluate sustained tolerability, quality of life, and change~     in cognitive efficiency following treatment with OnabotulinumtoxinA and daily topiramate vs.~     OnabotulinumtoxinA and daily placebo (Group A vs. Group B).~   "
142631|NCT01700374|"~     The purpose of this study is to determine how difficult life-events that women experienced~     during their childhood might affect their babies.~      Women who are asked to participate in this study will fill out forms about their physical and~     mental health, have 3D ultrasounds of their baby's adrenal gland, have their stress responses~     measured and have their baby's development and stress responses assessed.~   "
142632|NCT01700361|"~     This study will examine whether measurement of pelvic floor muscle sEMG activity is~     responsive to explicit sexual stimuli, and whether it correlates with self-reports of sexual~     arousal in healthy women. Participants' vaginal, labial and anal sEMG readings will be~     monitored during exposure to neutral, erotic and anxiety-provoking films. Participants will~     also be required to provide subjective ratings of sexual arousal before and after each film.~     If pelvic floor sEMG is validated as a psychophysiological measure, these findings may have~     important clinical and research implications by providing a greater understanding of the~     mechanisms involved in sexual arousal and for providing a relatively easy method of assessing~     sexual arousal in a clinical or research setting.~   "
142633|NCT01700348|"~     In the current study, Sonicare AirFloss (AF) will be used in combination with a Manual~     Toothbrush (MTB) in a population of manual toothbrush users who are irregular flossers and~     who exhibit signs of moderate gingivitis. The alternate test arm will be allocated to a No~     Intervention group and will be given no test products or instruction other than to change~     none of their typical at home oral hygiene habits.~      The aim of this study is to investigate how an AF and MTB oral hygiene intervention will~     affect a population of irregular flossers using the residual protein concentration method as~     an interproximal plaque efficacy assessment. Gingivitis reduction will be assessed using the~     Modified Gingival Index (MGI) and Gingival Bleeding Index (GBI) indices~   "
142634|NCT01700335|"~     The purpose of this study is to investigate tolerability when SyB L-1101 is administered~     intravenously in patients with recurrent/relapsed or refractory myelodysplastic syndrome, to~     determine the dose-limiting toxicity and maximum tolerated dose, and to estimate the~     recommended dose for phase II studies. Pharmacokinetics and antitumor effects will also be~     investigated.~   "
142655|NCT01700062|"~     aimed at investigating the efficacy, safety, and clinical outcome of Medium-Calorie or~     standard-calorie total parenteral nutrition (TPN) for patients with gastrointestinal cancer~     undergoing surgery~   "
142635|NCT01700322|"~     Endothelial dysfunction is an important predictor - and a determinant - of adverse clinical~     outcome. Endothelial function is impaired by coronary artery stenting, a stud from our group~     has shown that it can be improved by platelet inhibition using clopidogrel. However,~     clopidogrel unresponsiveness is a known problem, and it has been show that the endothelial~     effects of clopidogrel tend to wane upon prolonged treatment. Whether a more effective~     anti-platelet therapy is able to prevent/improve not only thrombotic events but also~     endothelial dysfunction, with potential positive impact on clinical outcome in patients~     undergoing coronary artery stenting, is an important hypothesis that needs to be further~     investigated. To date, evidence regarding ancillary (non-platelet-dependent) effects of~     antiaggregant drugs is very limited. For instance, while their antiplatelet effects, and~     their beneficial effects in patients with acute coronary syndromes, have been clearly~     demonstrated in multicentric trials, it remains to be shown whether these drugs also protect~     endothelial function. Interestingly, some authors suggest that the mortality benefit observed~     in the PLATO study is at least in part independent of direct antiplatelet effects. No study,~     to date, has tested the effects of prasugrel and/or ticagrelor on endothelial function. With~     the present trial, the investigators plan to test the effect of clopidogrel, prasugrel and~     ticagrelor on endothelial function before and up to 4 weeks after coronary artery stenting.~     This study will provide important pathophysiologic insight on the relationship between~     platelet aggregation and endothelial function, two parameters that have been shown to~     influence patients' prognosis.~   "
142636|NCT01700309|"~     The prevalence of overweight and obesity is increasing throughout the world. Obesity is seen~     as one of the most important public health threats because of the significant impact of~     chronic conditions associated with obesity. Obesity during adolescence is a strong precursor~     of obesity and related morbidity in adulthood.~      Interventions aimed directly at reducing weight or preventing increase in weight shows~     limited results on long term effects and it is shown that increase in activity has more~     impact on health outcome than on weight-loss. Further, weight-loss does not seem to be an~     appropriate measure of therapeutic interventions for growing children. The hypothesis of this~     study is that focusing on increasing meaningful physical activity through individual tailored~     counselling will have positive effects on the adolescents' fitness (health) and quality of~     life. Thus, the overall purpose of the study is to examine the extent to which a web-based~     intervention influences physical activity, fitness and quality of life in over-weight and~     obese adolescents Further, the aim is to explore and describe how adolescents experience~     being over-weight and obese, what they perceive as meaningful physical activity and finally~     how adolescents experience lifestyle changes as demanded in the intervention study.~   "
142637|NCT01700296|"~     Patients with chronic obstructive pulmonary disease, also known as COPD or emphysema, is like~     any other with a chronic illness not only affected by the physical discomfort the illness~     gives. For COPD patients that is: accelerated loss of lung function, conditioning and~     increased mortality: 25% of patients hospitalized with COPD exacerbation die 12 months later.~      Patients are also characterized by various psychological factors such as reduced quality of~     life, depression, etc.~      Therefore, everywhere in the country newly diagnosed COPD patients are offered rehabilitation~     in Region Zealand which consists of 10 weeks of classes 2 hours, 2 times a week with physical~     exercise, smoking cessation, medication, nutrition education and psychosocial support and~     patient education based on the National Health Service and international recommendations.~      In the literature, the effect of rehabilitation on quality of life was measured using a~     questionnaire (St. George Respiratory Questionnaire (SGRQ)), and the increase in function has~     been measured using a walk test, but there are no studies which look at the effect on~     inflammation lungs.~      It is important for COPD patients is to prevent exacerbations of the disease, which sometimes~     requires hospitalization and sometimes treated by their own doctor. It has been proven that~     inflammation in the lungs is associated with disease severity and exacerbation frequency, and~     therefore we would like to investigate whether both rehabilitation, close monitoring of~     patients with time in the pulmonary clinic every 3 months, and instruction in~     self-administration of medication (antibiotics and corticosteroids) have an effect on~     especially inflammation in the lungs, number of exacerbations, mortality, lung function and~     walking capacity.~   "
142638|NCT01700283|"~     The aims of this four-year study are to~        1. Explore exercise behavior, exercise barriers, and identify the significant factors for~          exercise behavior in colorectal cancer survivors.~        2. Explore the relationships among fatigue, muscle strength, and metabolomics and further~          examine the possible biomarkers from muscle strength and metabolomics for fatigue.~        3. Develop a clinical guidelines of home-based fatigue management and exercise program and~          test its effect on decreasing fatigue for patients with colorectal cancer after surgery~          in Taiwan.~   "
142639|NCT01700270|"~     This is a multi-center, open-label, single-sequence, crossover, drug-drug interaction (DDI)~     study to assess the effect of the CYP1A2 inhibitor, fluvoxamine, on the PK of dovitinib in~     patients with advanced solid tumors, excluding breast cancer. The purpose of this study is to~     evaluate the effect of a CYP1A2 inhibitor, 100 mg fluvoxamine, on the PK of dovitinib when~     administered at a dose of 300 mg on the dosing schedule, 5 days on/2 days off. The study will~     consist of 2 phases: a Pharmacokinetic (PK) phase and a clinical treatment phase. The DDI~     test will be conducted in the PK phase. The DDI test will assess the steady state PK profile~     of dovitinib when administered alone and in the presence of the CYP1A2 inhibitor, fluvoxamine~     (AUC 0-24h, AUC 0-72h and Cmax parameters). During the clinical treatment phase patients may~     continue to receive treatment with TKI258 until disease progression (assessed by RECIST 1.1),~     unacceptable toxicity, death or discontinuation from the study treatment for any other~     reason.~   "
142640|NCT01700257|"~     Lung cancer is the number one cancer killer in the USA. Early stage lung cancer is~     asymptomatic. Most patients with lung cancer are usually symptomatic at diagnosis and already~     have advanced stage disease. Low dose CT screening (LDCT) for high risk individuals has~     recently been shown to decrease lung cancer mortality by 20%. However, 4 out of 5 lung cancer~     deaths are not prevented with LDCT screening alone.~   "
142641|NCT01700244|"~     An evaluation of a safety and performance of a new cardiac pacemaker~   "
142818|NCT01697943|"~     The purpose of this study is to find out more about differences of the quality of life in~     patients undergoing Roux-En-Y pouch reconstruction and conventional Roux-En-Y reconstruction.~     To find a better reconstruction for patients who received total gastrectomy.~   "
142642|NCT01700231|"~     Introduction Liver resection is considered the only curative treatment option for mCRC~     patients without extrahepatic disease and is accepted practice. Despite substantial~     improvements in surgical techniques, postoperative morbidity and mortality remain an~     important concern after major resections. Complications of liver resection, although rare,~     include liver failure and acute kidney injury as indicated by oliguria and increased serum~     creatinine. The underlying pathophysiological pathways of post-operative renal alteration~     following liver resection is an increase in portal venous pressure, based on observations in~     animal models or small cohorts. The corpus of data is derived from patients with liver~     cirrhosis and subsequent hepatorenal syndrome. These data are limited since cirrhosis cannot~     distinguish between metabolic changes, portal hypertension and impaired liver function in the~     elucidation of the pathogenesis of renal alterations. Liver resection is therefore a potent~     model to evaluate the impact of portal hypertension on the kidney despite stable liver~     function.~      The most significant factor determining morbidity and mortality following hepatectomy is the~     ability of the remnant liver to regenerate. In this context, several growth factors were~     shown to regulate the highly orchestrated process of liver regeneration (LR).~      Hypothesis The investigators will therefore test the hypothesis that liver resection leads to~     a sustained increase of portalvenous pressure with a subsequent episode of oliguric renal~     impairment, correlating with the quantity of resected liver.~      Furthermore, the investigators will examine the relationship between postoperative liver~     regeneration and circulating growth factor levels in patients undergoing hepatectomy. Based~     on the preclinical data the investigators hypothesize that a circulating growth factor levels~     will be associated with delayed liver regeneration, an increased incidence of postoperative~     liver dysfunction and concomitant worse clinical outcome.~   "
142643|NCT01700218|"~     The purpose of the study is to test a new medical device for optimizing treatment of heart~     failure and compare its effect on outcome of patients with a recent hospitalization for~     worsening heart failure~   "
142644|NCT01700205|"~     The overarching goal of the research we propose here is to conduct a randomized clinical~     trial to specify the physiologic and behavioral mechanisms by which infant-formula~     composition affects all aspects of energy balance and growth during the first years of life.~   "
142645|NCT01700192|"~     The purpose of this study is to assess the efficacy and safety of MK-8237 (SCH 900237) in the~     treatment of House Dust Mite (HDM)-Induced Allergic Rhinitis/Rhinoconjunctivitis (AR/ARC) in~     children and adults.~      The primary hypothesis of this study is that administration of MK-8237, compared to placebo,~     results in significant reduction in the average total combined rhinitis score (TCRS).~   "
142646|NCT01700179|"~     The purpose of this study is to evaluate the safety, tolerability and efficacy of 12 weeks of~     treatment with ACH-0143102 and ribavirin in GT1b, treatment-naive, HCV subjects.~   "
142647|NCT01700166|"~     The specific aims of this study are:~        1. To determine if Human Umbilical Cord Blood (hUCB) infusion is safe in children with~          perinatal arterial ischemic stroke (AIS).~        2. To determine if late functional outcome, physiologic response, and anatomic findings are~          changed following hUCB infusion in children with perinatal AIS.~   "
142648|NCT01700153|"~     Cerebral Palsy (CP) is a major cause of impairments in child population. This disease~     justifies an intensive and prolonged multidisciplinary rehabilitation which can be optimised~     by robotics.~      Our team has developed a robot designed to rehabilitate the child's upper limb. This robot~     allows the patient to perform active, passive, or assisted exercises.~      This therapy is designed to promote motor development in children with CP. Its finality is to~     improve patients' quality of life and participation.~      Several pilot studies evaluated the efficacy of robotic assisted therapy in children with CP~     but none RCT has been done.~      Then, the aim of the study is to evaluate the efficacy of robotic-assisted therapy in~     children with cerebral palsy by evaluating the 3 fields of the ICF (International~     Classification of Functioning, Disability and Health) and performing a prospective randomized~     controlled single blind trial. Therefore, all patients will benefit from a classical~     rehabilitation as a basis. Furthermore, patients of the control and experimental groups will~     receive a supplement of classical rehabilitation and robotic-assisted therapy, respectively.~   "
142649|NCT01700140|"~     The purpose of this study is to explore the dose response of SyB D-0701 for preventing nausea~     and emesis associated with radiotherapy (fractionated/localized irradiation) in cancer~     patients scheduled to receive radiotherapy (fractionated/localized irradiation) alone.~   "
142650|NCT01700127|"~     This will be a randomized study with the primary objective of assessing the impact of~     withholding versus encouraging breastfeeding on the immunogenicity of Rotarix® in infants.~      Enrolled subjects will all be administered Rotarix®, at ages 6 to 7 weeks, and at10 -14~     weeks. The subjects will be randomized into one of the two study arms. In one of the group~     caregivers will be advised to breastfeed immediately prior to and after each dose of the~     vaccine while in the other group caregivers will be advised to withhold breastfeeding for 30~     minutes before and after each dose of the vaccine. The other childhood vaccines i.e. OPV and~     Pentavalent will be administered at least 30 minutes after administration of Rotarix®, The~     enrolled subjects will be followed up for 4 weeks after the 2nd dose of Rotarix®.~   "
142651|NCT01700114|"~     The purpose of this study is to collect data to describe the real-world use and safety and~     effectiveness of MelaFind® in a post-approval clinical setting.~   "
142652|NCT01700101|"~     We have added objectives 4-6 to our updated study:~      Study Objective 1: To determine whether the distribution of MelaFind scores is different for~     different patients with multiple nevi, and whether such distributions can be utilized to~     identify signature lesions for a given patient.~      Study Objective 2: To investigate whether distributions of quantitative ABCD parameters~     differ among patients and whether these qABCD parameters identify signature lesions.~      Study Objective 3: To determine the feasibility of defining and using relative thresholds to~     improve the specificity of MelaFind without sacrificing its high sensitivity.~      Study Objective 4: To determine the repeatability of MelaFind scores for a given lesion for~     different patient and lesion characteristics.~      Study Objective 5: To identify patient and lesion characteristics that result in the highest~     variability of MelaFind scores for a given lesion.~      Study Objective 6: To use standard errors of MelaFind scores to propose a robust individual~     threshold for lesions to be considered for biopsy to rule out melanoma on patients with~     multiple nevi.~   "
142653|NCT01700088|"~     At our institute,during the first 2 hour postoperative, we used to give supplement oxygen via~     face mask in patient having lung resection surgery. After then if the patient is fine, we'll~     replace the face mask with nasal cannular untie the next morning. We hypothesized that oxygen~     mask can be replace by nasal cannular without any hypoxia.~   "
142654|NCT01700075|"~     Study the mechanisms of atherosclerosis based on a comparative study of physical and chemical~     properties of lipid tissues at various localization with subsequent development of concept of~     treatment and prevention.~   "
142657|NCT01700036|"~     This clinical trial will study the safety and efficacy of using the drug Zemaira, an Alpha~     1-Antitrypsin (AAT) medication (also known as an Alpha1-Proteinase Inhibitor [Human]) for the~     treatment of steroid refractory GVHD.~      For bone marrow transplant patients, the most common, serious complication is Graft vs Host~     Disease (GVHD), which at its most severe is a life-threatening, complication and a~     significant cause of treatment related death, following stem cell transplantation. GVHD is a~     major obstacle to the overall success of transplant treatment, a strategy that would~     otherwise provide the possibility of a cure for patients with blood cancers or severe blood~     disorders. GVHD primarily affects the skin, gut, and liver of the recipient, and involves the~     interaction of the recipient's (the host's) cells and tissues with the donor's immune system~     cells that see the host tissues as foreign, and attack the host's cells resulting in tissue~     and organ damage.~      The severity of acute GvHD ranges from mild to severe, and for patients who don't respond to~     steroid therapy, the complication is nearly always fatal, either from organ damage or~     opportunistic infection as a consequence of high dose, steroid treatments.~      There is currently no known effective therapy for patients with acute graft vs host disease~     that's refractory (nonresponsive) to steroid therapy. As stated earlier,the overwhelming~     majority of these patients may ultimately die from infection. The incidence of acute GvHD~     that requires intervention, is higher for unrelated donor transplants, the most common~     treatment option available, and therefore, these patients are at higher risk for treatment~     related complications from GVHD. Approximately 20,000 unrelated donor transplants are~     performed each year. The magnitude of this problem then is significant for patients who~     otherwise might be cured of their blood cancer or disease.~   "
142658|NCT01700023|"~     The purpose of the study is two-fold:~        1. to test 3-dimensional reconstruction of leg-edema in patients hospitalized for acute~          heart failure with leg-edema.~        2. to measure changes in QRS-morphology in a simulation of conventional blood-pressure~          measurement in patients hospitalized for acute heart failure.~   "
142659|NCT01700010|"~     This study will involve subjects who have advanced urothelial cancer who are platinum~     refractory (platinum based chemotherapies that are not effective in treating the cancer), and~     who are over-expressing EGFR and/or HER2, or do not over-express EGFR and HER2. Genetic~     expression is a process that takes inherited information in genes (like DNA sequence), and~     from that information makes a specific functional product (sometimes called a gene product)~     such as RNA (ribonucleic acid) or protein. Normal tissue cells have a particular genetic~     expression, which changes when they turn into cancer. EGFR and HER2 are involved in the~     process by which normal cells are transformed into cancer cells.~      The main purpose of the study is to look at the proportion of subjects, who over-express EGFR~     and/or HER2, who do not progress (cancer gets worse) after 16 weeks of study treatment with~     daily lapatinib and weekly paclitaxel. The study will also look at the safety and~     effectiveness of this therapy in all subjects.~      Another part of this study will look at blood and tissue samples. Blood samples will be~     collected to see how many cells express EGFR and HER2 before study treatment and at the time~     the cancer gets worse. Tumor tissue will be analyzed to look at the expression of certain~     genes in advanced urothelial cancer. Some gene expression tests can reveal how cancer cells~     are different from normal cells and the results might lead to more accurate diagnosis and~     treatment.~   "
142660|NCT01699997|"~     Background: A large body of research has shown that Oxytocin (OXT) is an important prosocial~     peptide and there is also initial evidence that the central OXT system is altered in several~     mental disorders that are characterized by severe social disturbances and deficits, such as~     anxiety disorders with prominent social dysfunction (e.g., schizophrenia), mood disorders and~     borderline personality disorder. OXT may reduce psychotic symptoms and may diminish certain~     social cognition deficits that are not improved by current antipsychotic medications.~      Aims: The project has two main aims, listed below:~        1. To assess the efficacy of intranasal OXT in reducing negative symptoms in patients with~          schizophrenia in association with second-generation antipsychotics (SGA);~        2. To use an Emotional Priming Paradigm task to assess pre- and post-treatment change in~          the patients general cognitive and emotional status.~      Study Design: Randomized, double-blind, placebo-controlled, cross over design. Materials and~     methods: Patients involved in the study will be recruited in six centres in the north of~     Italy. Each subject (aged 18-45, with a duration of the disorder no longer than 10 years)~     will be enrolled after a screening phase. 80 patients will be randomly assigned to either 40~     IU OXT once daily or vehicle placebo, in addition to their pre-study antipsychotic medication~     regimen: all reasonable attempts maintain the same SGA dosages throughout the study will be~     made. The study ratio is 1:1. The total study duration for each individual subject will be~     approximately 8 months, which includes an up to 7-day screening period, a baseline~     randomization visit, and a four month long cross-over treatment period. Subjects will be~     trained by researchers about the self-administration of intranasal OXT. A trustworthy~     caregiver will be trained as well. Each patient will receive every morning a SMS text message~     on his mobile phone as a reminder for OXT administration.~      Before starting the treatment, all patients will be assessed with standardized assessment~     instruments and will undergo an in depth neuropsychological assessment; additional~     evaluations, including safety evaluations, will be performed at 4 and 8 month follow-ups.~      The primary outcome measure will be the negative score in the Positive and Negative Syndrome~     Scale (PANSS) performed at 2,4,6 and 8 months since the start of the treatment.~   "
142661|NCT01699984|"~     This prospective observational cohort study aims at studying functional and clinical outcomes~     of patients (N = 329) admitted to 4 geriatric hospital facilities of the St John of God Order~     in Northern Italy during an index period of 4 months. Other areas assessed include variables~     that help or hinder the discharge of patients with sufficient residential autonomy and the~     predictive ability of clinicians compared with the evaluation of selective indicators of~     outcome (clinical and instrumental).~      Patients are followed from the first day of hospitalization until discharge or up to 3 months~     and 1 day after the date of admission (long-term care patients).~      At admission a Patient Form including social, demographic and clinical informations and a~     series of standardized assessment tools is completed with the help of clinicians, nurses and~     caregivers (when available).~      For each patient, during hospitalization, an analysis of apolipoprotein ApoE polymorphisms is~     performed and adverse events occurred during hospitalization are monitored, as well as the~     predictive abilities of clinicians and any recent CT and MRI. Patients are reassessed at~     discharge (or after 3 months for long-term care patients) and at 6 months follow-up of with~     a standardized telephone interview to assess clinical and functional status and possible~     changes in the residential status of the patient.~   "
142662|NCT01699971|"~     The primary aim is to evaluate if PSH and/or ultrapro mesch reduces chronic groin pain~     postoperatively compared to lichtenstein mesh. The second aim is to evaluate quality of life,~     recovery from surgery and frequency of recurrencies in the three groups~   "
142663|NCT01699958|"~     The purpose of this study is to refine, evaluate the feasibility, and to estimate the effect~     of the healthy Living Study, a brief outpatient problem-solving intervention to promote~     healthy eating and activity habits in adolescents.~   "
142850|NCT01697488|"~     This observational study will evaluate the safety, efficacy, quality of life and~     predictive/selection factors for Avastin (bevacizumab) in combination with~     carboplatin/paclitaxel in first line in patients with advanced epithelial ovarian, fallopian~     tube or primary peritoneal cancer in clinical practice. Data of eligible patients will be~     collected during up to 15 months of treatment and 12 months of follow-up. A second~     recruitment phase has been opened to focus on patients >/= 70 years.~   "
142664|NCT01699945|"~     The goal of this study is to generate unique information to guide improvements on~     interventions to reduce maternal and newborn mortality as well as prevent stillbirths.~      The objective of this study is to determine the burden, timing, and causes of maternal~     deaths, stillbirths and neonatal deaths.~      This will be an observational study where data will be collected retrospectively in the~     context of the ongoing study in Haryana, India.~      Women of reproductive age living in the study area have already been enumerated for the~     parent studies. Active surveillance is being conducted for identifying pregnancies and deaths~     among women of reproductive age in the population through 3 monthly home visitations.~      Verbal autopsies will be conducted for all deaths of women in the reproductive age, including~     those who died in pregnancy, childbirth and up to 42-60 days after childbirth. Verbal autopsy~     interviews will also be conducted for all stillbirths.~   "
142665|NCT01699932|"~     Primary Objective:~      -To demonstrate the efficacy of a fixed combination of glimepiride + metformin in terms of~     HbA1c reduction, during 24-week treatment period in patients with inadequately controlled~     type 2 diabetes mellitus.~      Secondary Objective:~      To assess the effects of the fixed combination of glimepiride and metformin at week 24 on:~        -  Percentage of patients reaching HbA1c <7%~        -  Percentage of patients reaching HbA1c <6.5%.~        -  Fasting Plasma Glucose (FPG)~        -  Safety and tolerability~   "
142666|NCT01699919|"~     The primary objectives of this study are to analyse the effect of perioperative systemic~     infusion of lignocaine on postoperative pain, postoperative nausea and vomiting and~     perioperative levels of inflammatory mediators in patients undergoing elective open abdominal~     surgeries.~      The secondary parameters which will be observed during the study are the time to passage of~     flatus and stools postoperatively.~   "
142667|NCT01699906|"~     Breast cancer is one of the most frequently seen cancers in the United States. It occurs at~     all ages but is particularly common in post menopausal women. Obesity increases the risk of~     breast cancer and colon cancer among others, and when cancer develops increases the risk of~     spread and death. Inflammation of fat tissue, the coronary blood vessels and the liver are~     also seen with obesity. Animal experiments have shown the inflammation in fat tissue~     increases the production of estrogen. Thus, reducing inflammation in fat tissue might lower~     estrogen levels and reduce the risk of breast cancer in obese women as well as the spread of~     other cancers in the body. Weight reduction in obesity has been shown in epidemiology studies~     to lower the risk of colon cancer and in obese women to lower the risk of breast cancer.~     However, how that occurs and how much weight loss is necessary is not known. In mice, calorie~     restriction in obese animals has been shown to reduce inflammation in fat tissue and the~     breast. In other studies, calorie reduction has been shown to lower the development of~     cancer. In addition, we really do not know what starts the whole inflammation process. One~     good possibility is that immune factors that tend to reduce inflammation are less in obesity.~     We have shown this in the colon and this also has been suggested as occurring in fat stores.~   "
142668|NCT01699893|"~     The purpose of this study is to assess the determinants of immunologic variance within the~     general healthy population.~   "
142669|NCT01699880|"~     Tracheal intubation of critically ill patients is associated in the intensive care unit (ICU)~     with significant complications and morbidity. Patient desaturation is one of the most common~     complications that may lead to cardiac arrest despite pre-intubation oxygenation.~     Preoxygenation can be improved by the use of non-invasive ventilation, but this technique can~     be cumbersome to implement in the context of urgent intubation and more importantly it does~     not insure oxygenation during intubation. High flow nasal cannula oxygen therapy is a~     technique that has been shown to improve patient oxygenation in the context of acute~     hypoxemic respiratory failure. It bears the potential to be of clinical benefit in the~     setting of tracheal intubation in the ICU to ensure patient safety. The purpose of this study~     is to compare pre- and per-intubation (during intubation) oxygenation with either a~     conventional high FiO2 oxygen bag reservoir facemask (current standard practice) or high flow~     nasal cannula oxygen therapy (new practice to be implemented in our ICU).~   "
142670|NCT01699867|"~     This multi-center, prospective, open label study analyzed specimens from fifty subjects at~     two study sites. Patients scheduled to undergo breast-conserving surgery were recruited in~     accordance with the inclusion and exclusion criteria. The study period per subject was the~     time it took to assess the ex vivo breast tissue sample using the study device. Image review~     was conducted after surgery and compared to the margin status findings in the post-operative~     pathology report.~   "
142671|NCT01699854|"~     In the present study the investigators intend to investigate analgesic and sensory effects of~     a capsaicin patch 8 %(Qutenza) in patients with severe post-herniotomy pain and sensory~     abnormalities in the skin.~   "
142672|NCT01699841|"~     The purpose of this study is to understand how breast milk may protect infants from infection~     and promote favorable immunological, growth and development outcomes. By following mothers~     and their infants, we will evaluate the important interactions between infant immune~     responses and infectious disease events in relation to breast milk composition and feeding~     patterns. Our aim is to identify a set of predictive factors corresponding to healthy early~     infant growth and development in this setting in Northern Tanzania.~   "
142673|NCT01699828|"~     The objective of the present study is to use positron emission tomography brain imaging to~     investigate D3 occupancy of buspirone, an FDA-approved anxiolytic which acts as a serotonin~     partial agonist but has recently been identified as a D3 antagonist. It is hypothesized that~     clinically relevant doses of buspirone will occupy the D3 receptor.~   "
142674|NCT01699815|"~     The purpose of the study is to examine the effects of timing of administration of intravenous~     (IV) acetaminophen and how timing relates to analgesic efficacy as measured by postoperative~     pain scores. A maximum of 138 patients meeting inclusion criteria who present for a scheduled~     total hip replacement under general anesthesia will be randomized into one of two arms: 1)~     the pre-closure group will receive the first dose administered upon onset of skin closure, 2)~     the preemptive group will receive the first dose administered within 60 minutes prior to~     incision. Both groups will receive subsequent doses every 6 hours x 24 hours.~   "
142854|NCT01697436|"~     This four-period, single-center, open-label, single-dose, randomized, cross-over study will~     assess the bioequivalence and safety of an oral solution of Copegus (ribavirin) compared to a~     Copegus tablet in healthy adult volunteers. Volunteers will be randomized to one of four~     sequences in which they will receive the treatment under fed and under fasted conditions.~   "
142676|NCT01699789|"~     CPIC is a community initiative and research study funded by the NIH. CPIC was developed and~     is being run by community and academic partners in Los Angeles underserved communities of~     color. CPIC compares two ways of supporting diverse health and social programs in~     under-resourced communities to improve their services to depressed clients. One approach is~     time-limited expert technical assistance coupled with culturally-competent community outreach~     to individual programs, on how to use quality improvement toolkits for depression that have~     already been proven to be effective or helpful in primary care settings, but adapted for this~     study for use in diverse community-based programs in underserved communities. The other~     approach brings different types of agencies and members in a community together in a 4 to~     6-month planning process, to fit the same depression quality improvement programs to the~     needs and strengths of the community and to develop a network of programs serving the~     community to support clients with depression together. The study is designed to determine the~     added value of community engagement and planning over and above what might be offered through~     a community-oriented, disease management company. Both intervention models are based on the~     same quality improvement toolkits that support team leadership, care management, Cognitive~     Behavioral Therapy, medication management, and patient education and activation.~     Investigators hypothesized that the community engagement approach would increase agency and~     clinician participation in evidence-based trainings and improve client mental health-related~     quality of life. In addition, during the design phase, community participants prioritized~     adding as outcomes indicators of social determinants of mental health, including physical~     functioning, risk factors for homelessness and employment. Investigators hypothesized by~     activating community agencies that can address health and social services needs to engage~     depressed clients, these outcomes would also be improved more in the collaboration condition.~     Investigators also hypothesized that the collaboration approach would increase use of~     services.~   "
142677|NCT01699776|"~     It is established that at a serum concentration 0.5-0.9 ng/ml digoxin is effective in~     patients with heart failure, especially in the presence of atrial fibrillation (AF). It is~     the claimed that ivabradine by lowering heart rate reduces symptoms and improves clinical~     outcomes in patients with heart failure. The effect of ivabradine and digoxin in heart~     failure was compared.~      Patients 22 patients with ischemic heart failure, AF, and diastolic dysfunction with~     preserved left ventricular systolic function were treated with digoxin and ivabradine for 3~     months, according to a randomization cross-over design.~      Collected data Medical history, physical examination, laboratory (including proBNP and serum~     digoxin concentrations), ECG, 6-minute walk test, and echocardiographic data (LVEF, LAVi,~     e/e1 ratio).~   "
142678|NCT01699763|"~     The purpose of this study was to evaluate the performance of a Bayer Blood Glucose Monitoring~     System (BGMS) and two additional Blood Glucose Monitoring Systems (BGMS) from other~     companies. All meter BG results were compared with plasma results obtained with a reference~     laboratory glucose method (YSI Glucose Analyzer).~   "
142679|NCT01699750|"~     The purpose of this study is to evaluate the lipid uptake, wetting characteristics, and~     visual performance of AIR OPTIX® AQUA and ACUVUE® OASYS® with HYDRACLEAR® contact lenses when~     used in conjunction with two contact lens care systems.~   "
142680|NCT01699737|"~     The purpose of this study is to evaluate the effect of JTT-851 on diabetes as well as to~     assess the safety, tolerability, and pharmacokinetics of JTT-851 in type 2 diabetic patients~     either treated with metformin or treatment-naïve.~   "
142681|NCT01699724|"~     The purpose of this study is to assess the bioequivalence of Zoloft ODT 50 mg with and~     without water to Japanese commercial oral tablet of JZoloft 50 mg under fasting condition~     with water in Healthy Japanese Subjects~   "
142682|NCT01699711|"~     Epigallocatechin-3-gallate (EGCG), the major catechin in green tea, is postulated to modulate~     dual specificity tyrosine-phosphorylation-regulated kinase 1A (DYRK1A) and amyloid beta~     precursor protein (APP) gene overexpression in the brains of Down syndrome mouse models. The~     clinical study is aimed at demonstrating that normalization of Dyrk1A and APP functions is a~     therapeutic approach to improve cognitive performance and decelerate AD (Alzheimer's disease)~     like progression.~   "
142683|NCT01699698|"~     Purpose of this study is to understand the clinical feasibility of duodenal juice diagnosis~     to screen UICC stage II pancreatic ductal adenocarcinoma patients.~   "
142684|NCT01699685|"~     The study purpose is to evaluate the effect of QAB149~        -  NVA237 vs. QAB149 on static lung hyperinflation.~   "
142685|NCT01699672|"~     The main aim of the current study is to investigate whether the addition of a~     standardized,group-based educational program to the information provided by health care~     personnel improves cancer patients' knowledge level about their disease, planned treatment~     and common side-effects of the treatment.~      Secondary aims are to investigate if the addition of the educational program increases the~     likelihood of completing treatment as planned, reduces level of anxiety, reduces the~     frequency of serious side effects, increases patient reported health related quality of life,~     and increases the degree of patient satisfaction with respect to how they have received the~     information before, during and after treatment.~   "
142686|NCT01699659|"~     Hypothesis: The UAS Immunotherapy protocol is efficacious and at least as efficacious as~     protocols described in the Allergy literature.~   "
142687|NCT01699646|"~     Hypothesis:~      STAN monitoring will reduce the number of interventions because of suspected fetal asphyxia~     and reduce the number of newborns with metabolic acidosis.~      Primary endpoint:~      1) Frequency of metabolic acidosis in the two groups, defined by pH in umbilical cord artery~     < 7.05 and standard base excess <-10.~      Secondary endpoints:~        1. Number of intervention (VE and caesarean section) in the two groups~        2. Number of pH measurements in the two groups~        3. Number of neonates admitted to the neonatal department because of suspected asphyxia in~          the two groups~      The aim of fetal surveillance is to identify those fetuses at risk for developing damage in~     newborn to term or long term damage caused by lack of oxygen during birth process.~     Approximately 1/10 of all cases of paralysis due to brain damage (cerebral palsy) is believed~     to be caused by lack of oxygen during birth. These can be avoided if the investigators~     intervene actively in the birth before damage occurs.~      CardioTocoGraphy (CTG = detection of fetal heart rate pattern and maternal uterine~     contractions via electrodes on the maternal abdomen and fetal scalp) is a widely used method~     of fetal surveillance. However, it can be difficult to interpret a CTG, and uncertainty in~     CTG interpretation may therefore lead to increase in the number of deliveries with vacuum~     suction and caesarean section. Interpretation of CTG can be improved by analyzing the acidity~     of a blood sample taken from the skin of the fetal scalp. Such a scalp pH analysis shows~     indirectly the fetus gets enough oxygen. Scalp pH measurement requires expertise and requires~     repeated measurements if the abnormal heart rate pattern persists. This method is the normal~     routine at the maternity ward at Hvidovre Hospital / Roskilde County Hospital.~      The problem seems to be partially alleviated by using a newly developed method for fetal~     surveillance called STAN (ST analysis). By STAN continuously recorded both CTG and fetal ECG~     (electrocardiography = recording of the electrical heart activity). Simultaneously analyzes a~     portion of the fetal ECG, namely ST-part because hypoxia leads to changes in it. The~     technique is easy to use, since it only requires one electrode on the fetal scalp that is~     placed in the same way as in ordinary CTG registration.~   "
142688|NCT01699633|"~     Nevirapine is the preferred nonnucleoside reverse transcriptase inhibitor (NNRTI) for~     treatment of HIV in children younger than 3 years old who have tuberculosis (TB) coinfection.~     However, there is very limited data on the drug-drug interactions between rifampin and~     nevirapine in children of this age group. The purpose of this study is to determine the~     effect of rifampin-containing anti-TB treatment on the blood levels of nevirapine in young~     children with HIV and TB coinfection. Also, the study will find out whether checking the~     genetic makeup of a child could help to determine the appropriate dose of nevirapine in the~     setting of concomitant anti-TB treatment.~   "
142689|NCT01699620|"~     The study compares two different operative techniques for placement of the Cochlear Bi300~     implant to be used for bone anchored hearing aid. The operative techniques to be compared are~        -  Dermatome technique with soft tissue reduction~        -  Linear incision with minimal or no soft tissue reduction~      The hypothesis is that the operative techniques are comparable with regard to implant~     stability, soft tissue healing and loss of sensibility around the implant.~      To evaluate the evolution of implant stability during the early healing period after~     implantation, which is the most critical period for osseointegrated implants, in particular~     when early loading protocols are used.~      To compare soft tissue healing around Baha implants placed according to the recommended~     surgical technique with skin transplant and Baha implants without performing skin reduction.~      To compare the loss of sensibility of the skin around the Baha implant (some loss of~     cutaneous sensibility nerves in the transplant procedure) between the two surgical~     procedures.~      While the study focuses on the early healing period (3 months), long-term safety data will~     also be collected after 6 months and 1-year.~      The study will also evaluate the change in health status produced by the surgical~     intervention.~   "
142690|NCT01699607|"~     A research study designed to examine amphetamine-induced dopamine release using the PET~     imaging agent [11C]PHNO in tobacco smokers while currently smoking and during acute~     withdrawal and in nonsmokers. Twenty healthy men and women tobacco smokers and twenty healthy~     nonsmokers will be recruited. Each subject will participate in 1 MRI and up to 2 [11C]PHNO~     PET scans. On the study day subjects will participate in two [11C]PHNO scans (ideally, the~     two PET scans will be carried out in the same day). Three hours before the second PET scan,~     amphetamine (0.5 mg/kg, PO) will be administered. In smokers, the scan will occur at 10-21~     days of smoking abstinence.~   "
142691|NCT01699594|"~     Exposure to allergens changes the way the airway responds to some stimuli (methacholine). The~     investigators will look at whether or not exposure to allergens changes the way the airway~     responds to a different stimuli (mannitol) and compare that with the known stimuli~     (methacholine).~   "
142692|NCT01699581|"~     Nestle Impact has shown efficacy in multiple surgical trials in relation to improving~     hospital length of stay and infection rate. 1 dose of Nestle Impact Advanced Recovery will be~     taken orally three times a day beginning on the morning following stem cell transplant and~     will continue until the day of hospital discharge.~   "
142693|NCT01699568|"~     Objectives: To compare the stability of implant surface treated by dual acid etching~     (Porous)and implants with anodized surface (Vulcano) over a period of 16 weeks after~     installation.~      Methods: it will be a clinical study with individuals with missing teeth requiring~     rehabilitation with dental implants in the maxilla and that fulfill the study inclusion~     criteria. The research sites will be randomized into two groups: the control group patient's~     sites receive implant surface treated by dual acid (AR Torque Porous, Connection Implant~     Systems, Aruja, Brazil) and in the test group implants with anodized surface (AR Torque~     Vulcano-Actives, Connection Implant Systems, Aruja, Brazil). The evaluation of the stability~     of the implants will be made over 16 weeks, through resonance frequency analysis with Osstell~     (Integration Diagnostics AB, Gothenburg, Sweden). Data will be analyzed using descriptive~     statistics and comparative.~   "
142694|NCT01699555|"~     The purpose of this study is to assess the safety and tolerability of single ascending doses~     of GNbAC1 in healthy male subjects.~   "
142695|NCT01699542|"~     The purpose of this of this study is to compare the safety and effectiveness of temporary~     indwell of the WallFlex Esophageal FC Metal Stent to Bougie Dilation for the treatment of~     refractory anastomotic esophageal strictures~   "
142696|NCT01699529|"~     This is a prospective, single-arm, non-randomized and open label feasibility study. The study~     is intended to evaluate safety and efficacy of multi-electrode radiofrequency renal~     denervation in patients with uncontrolled hypertension.~   "
142697|NCT01699516|"~     Intestinal acute graft-vs-host disease (GVHD) is a life-threatening complication after~     allogeneic hematopoietic cell transplantation. Non-invasive diagnostic procedures are still~     lacking and diagnosis is difficult. We hypothesized that contrast-enhanced ultrasound~     sonography (CEUS) could detect microcirculation changes of the bowel walls during intestinal~     GVHD and help to detect and monitor treatment response. We employed CEUS to prospectively~     evaluate intestinal GVHD in 83 consecutive transplant patients between 2008 and 2011.~     Fourteen /83 patients with biopsy-proven intestinal GVHD were selected as study group.~     Fourteen patients with biopsy-proven stomach GVHD without intestinal symptoms (N=16), normal~     volunteers (N=6) and patients with neutropenic enterocolitis (N=4), were chosen as control~     group. All patients were evaluated with both standard transabdominal ultrasonography (US) and~     CEUS at the onset of intestinal symptoms, during clinical follow up and at flare of symptoms.~     Standard US revealed non-specific bowel wall thickening, and simultaneous involvement of~     multiple intestinal segments in 9/14 patients. CEUS showed three distinct patterns of~     microcirculation changes that correlated with GVHD activity. These findings were not observed~     in the control group. Moreover, CEUS findings correlated with treatment response and~     predicted flare of intestinal symptoms. CEUS is a non-invasive, easily reproducible bed-side~     tool to detect and monitor intestinal GVHD.~   "
142698|NCT01699503|"~     The purpose of the study is to conduct a randomized clinical trial assessing the harms and~     benefits of screening for dementia, compared to no screening for dementia, among 4,000 older~     adults, cared for in typical, primary care practices.~   "
142699|NCT01699490|"~     The purpose of this study is to identify evidence-based guidelines for treating major~     depressive disorder to full remission in Taiwanese major depressive disorder (MDD) patients.~     To achieve this goal, the investigators aim to: (1) evaluate the risks and benefits of~     adjunctive pharmacotherapies for cognitive and metabolic consequences in MDD, and (2) clarify~     the shared biological mechanisms between mood, immune and metabolism homeostasis~   "
142700|NCT01699477|"~     The aim of this study is to asses the efficacy and the clinical safety of the transcranial~     magnetic resonance guided high intensity focused ultrasound system ExAblate 4000, InSightec~     Ltd. for functional neurosurgery. The treatments to be conducted in this study are~     non-invasive, i.e. without opening the skull, and will create micro-thalamotomies in specific~     target areas such as thalamus, subthalamus and pallidum. The data obtained in this study will~     be used to evaluate the basic safety aspects of this new treatment technology and will serve~     as a basis for the clinical introduction of MR-guided ultrasound-neurosurgery.~   "
142702|NCT01699451|"~     This study is intended to obtain clinical information and establish a repository of DNA, RNA,~     peripheral blood monocyte, lymphocyte and skin tissue samples from people with ALS and~     related neurodegenerative motor neuron diseases, people with a family history of these~     conditions, and healthy people with no family history of these disorders. The samples will be~     used in future research to learn about how these disorders affect people, what causes these~     conditions, and how the investigators can tell when someone has this kind of disease. Future~     research may also include the generation of stem cells from stored blood cell and skin cell~     samples. Participants will not be paid for taking part in this study.~   "
142703|NCT01699438|"~     Irritable bowel syndrome (IBS) is a condition characterised by abdominal pain or discomfort~     in combination with altered bowel function (stool frequency and/or stool consistency),~     currently defined by the Rome III criteria. The current IBS definition specifies that there~     are no structural or biochemical abnormalities to account for the symptoms but there is~     growing evidence that in at least a subset of IBS patients, a discrete immune activation~     might be a key pathogenetic factor. The condition is prone to develop after a~     gastroenteritis, post-infectious IBS, and increased numbers of lymphocytes, mast cells and~     pro-inflammatory cytokines like Interleukin (IL)-1β, IL-6, Tumor necrosis factor (TNF)-α and~     a general increase in mucosal cellularity have been reported. Despite this, the efficacy of~     anti-inflammatory agents has been poorly investigated.~      This will be a randomised, double blind, placebo-controlled, parallel-group, multi-centre~     study that aims to include a total of 200 subjects with irritable bowel syndrome (IBS). All~     subjects will be randomised to receive either 3x800 mg of mesalazine (Asacol®) or~     corresponding placebo once daily for a total treatment duration of 8 weeks. Males and females~     aged 18 to 70 years who already are diagnosed with IBS based on the Rome III diagnostic~     criteria and with a symptom intensity of at least moderate level; defined as an IBS Severity~     Scoring System (IBS-SSS) score of ≥175 at both Screening (Visit 1, Day -21±2) and Baseline~     (Visit 2, Day 0) will be eligible to enter the study.~      Primary aim:~      To assess the effect of mesalazine (Asacol®) treatment compared to placebo on global IBS~     symptoms: A treatment responder will be defined by answering the satisfactory relief of~     IBS-symptoms question yes at the end of at least 4 out of of 8 treatment weeks.~      Secondary aims:~      To assess mesalazine (Asacol®) treatment compared to placebo regarding:~        1. Levels of inflammatory mediators in the rectal mucosa (e.g. neutrophil mediators,~          eosinophilic mediators, mast cell activity mediators and cytokines) measured by a new~          diagnostic tool, the Mucosal Patch Technology (MPT) by means of Enzyme-Linked~          Immunosorbent Assays (ELISA)~        2. Effects on number of immune cells (count per high power field) and cytokine content~          (immunohistochemistry) in mucosal biopsies~        3. Calprotectin levels in faeces (mg/kg)~        4. Individual IBS symptom parameters derived from a symptom diary and also measured by~          IBS-SSS~   "
142704|NCT01699425|"~     The transobturator tension-free vaginal tape (TOT) procedure has demonstrated high cure rates~     comparable to those obtained by retropubic suburethral tape, becoming the first line~     treatment for stress urinary incontinence (SUI) in many cases. The TOT procedure is not~     exempt from complications such as bleeding, bladder injuries and pain in the thigh/groin. In~     addition it is commonly performed under general or regional anesthesia1-3. The~     single-incision mini-slings (SIMS) were developed to reduce the risk of complications by~     avoiding the blind passage of the trocars through the obturator space. In addition, the use~     of SIMS could enable surgeons to perform the procedure truly under local anesthesia.~      Different devices for SIMS procedure are available. However, the evidence about their~     efficacy is controversial4-7. The main limitation of these devices could be the predetermined~     length of the mesh and the weakness on its fixation. The design of the SIMS Ajust® allows~     adjusting the length of the sling to each individual woman and provides a robust fixation~     into the obturator membrane. Recent prospective studies on the efficacy and safety of the~     sling Ajust® have obtained promising results8,9. Even so, the NICE guidelines advise to use~     SIMS in the context of research studies10.~      The objective of this study is to establish if the effectiveness of the SIMS Ajust® is~     non-inferior to that of a standard TOT, as well as to compare the comorbidity of both~     procedures. Owing to the new appearance and fast evolution of these procedures, randomized~     comparative studies with SIMS are required in order to determine its place in the treatment~     of SUI.~   "
142705|NCT01699412|"~     The purpose of this study is to perform a randomized, double-blind, clinical trial comparing~     the topical treatment with clobetasol or dexamethasone for symptomatic oral lesions of~     chronic graft-versus-host disease.~   "
142706|NCT01699399|"~     This prospective, randomized controlled trial compares traditional air insufflation with~     water immersion and water exchange in patients undergoing colonoscopy using on demand~     sedation. We test the hypothesis that compared with air insufflation the proportion of~     patients who require on demand sedation during colonoscopy will be significantly lowered by~     water immersion and water exchange, and water exchange will produce the greatest reduction~   "
142707|NCT01699386|"~     Effects on weight will be monitored in healthy infant subjects consuming assigned infant~     formulas.~   "
142708|NCT01699373|"~     A randomised controlled trial comparing the use of pre-procedural ultrasound scanning with~     manual palpation to identify landmarks for performance of spinal anaesthesia.~   "
142709|NCT01699360|"~     The aim of this study is to evaluate the potential of endogenous cortisol and cortisone~     metabolism as a biomarker for immunosuppressive agents disposition in Chinese renal~     transplant recipients. If the blood concentrations of immunosuppressants can be predicted~     successfully, this new probe may take place of current drug monitoring post transplantation.~   "
142710|NCT01699347|"~     Cohort study evaluate the efficacy treatment with OK-432 in cystic malformation of the head~     and neck region.~      The malformations are macrocystic and the preevaluation will include CT/MRI, US and blood~     tests.~      The injection will be in the OR under US guided, maximal dose will be 0.2mg. The follow-up~     will be of short term - till 30 days post injection and long term - follow-up wil be till 2~     years.~   "
142711|NCT01699334|"~     The purpose of this study is to examine the effect of an educational video on intensity of~     neck pain, disability, illness perceptions and work ability following acute whiplash trauma~     caused by motor vehicle accidents.~   "
142712|NCT01699321|"~     Physical activity has been proven to reduce the risk of cancer. The North Carolina FITShop~     research study will test the effectiveness of a program aimed at increasing physical activity~     among African American men. Approximately 14 barbershops and 560 shop customers within~     Orange, Durham, Chatham, Alamance, and Wake counties will be enrolled into this research~     study. If FITShop is effective, we will share our results throughout North Carolina and~     nationally.~   "
142851|NCT01697475|"~     This study examined the impact of using a motivational mobile text messaging intervention to~     increase step count among older community-dwelling African Americans. Secondary aims were to~     study the effects of text messaging on self-reported leisure time exercise behavior.~      Hypothesis:~      Participants in the motivational mobile text messaging group will have an increase step count~     after 6-weeks.~   "
142713|NCT01699308|"~     The current protocol aims to compare the brain-functioning (fMRI & EEG) and white matter~     structural integrity (DTI) of persons with mild to severe TBI with and without Growth Hormone~     deficiency during cognitive tasks; and to examine changes in cognitive and motor performance,~     EEG/fMRI and white matter integrity associated with growth hormone treatment for twelve~     months using an open-label design in persons with GH deficiency/insufficiency following mild~     to severe TBI. To meet this aim, we are in the process of screening 40 persons with mild to~     severe TBI, ages 18-55, who are at least six months post injury. After screening, 10 persons~     with TBI and GHD (Growth Hormone deficiency) will receive daily rhGH injections titrated to~     bring their GH levels into the normal range over the course of twelve months. Treatment will~     be initiated using rhGH (Genotropin). Subjects with TBI and GHD will be assessed at baseline,~     6 months, and 12 months with EEG, fMRI and DTI, and neuropsychological measures. 5 persons~     with TBI who do not have GHD will be assessed at baseline and at 12 months with EEG, fMRI and~     DTI, and neuropsychological measures.~   "
142714|NCT01699295|"~     There is currently considerable interest in both improving academic achievement (No Child~     Left Behind) and reducing the rates of obesity and its associated negative health~     consequences in elementary school students. Increased physical activity (PA) offers a~     potential intervention to address both issues. Evidence is available which suggests an~     association of PA with both academic achievement and obesity, and an association between~     obesity and academic achievement.~      To provide increased PA while maintaining academic instruction time, we developed a program~     we call Physical Activity Across the Curriculum (PAAC) in which regular classroom teachers~     were trained to deliver academic lessons using moderate to vigorous physical activity (MVPA)~     for 20 minutes/d, 5 days/wk. This study is looking to compare academic achievement between~     students in elementary schools that participate in academic lessons taught through MVPA~     (PAAC) to students that do not (CON).~   "
142715|NCT01699282|"~     To meet the wishes of the Ministry of Health, the division of Cardiology University Hospital~     of Clermont Ferrand, combining the cardiology and cardiac surgery department, has developed~     since January 2009, a therapeutic education to use oral anticoagulants, in collaboration with~     the functional rehabilitation center Durtol. All patients under VKA, are formed by nurses.~     The purpose of this local study, in cardiac surgery department, is to evaluate the~     therapeutic impact of two methods of comprehensive education, one conventional and performed~     by nurses service, less elaborate, relying solely on the book Information from The National~     Security Agency of Medicines and Health Products, the other based on more detailed documents~     created by a multidisciplinary group. Various studies show that the effect of therapeutic~     education is observed only during the first six months and then disappears.~      This study is the first French study evaluating the impact of a comprehensive education to~     oral anticoagulation according to the latest recommendations of the National Security Agency~     of Medicines and Health Products and the French National Health Authority.~   "
142716|NCT01699269|"~     This study will examine the use of a variation of standard magnetic resonance imaging (MRI)~     called diffusion tensor MRI (DT-MRI), in order to evaluate the peripheral white matter~     infiltration of high grade brain tumors. Organized architecture is destroyed once brain tumor~     cells are infiltrating surrounding tissue. The infiltrated tissue is then isotropic (or less~     anisotropic). DT-MRI can assess anisotropy after datasets post treatment. Primary outcome is~     to find if a correlation exists between GA (generalized anisotropy) and the infiltration~     percentage of stereotactic peritumoral biopsies.~   "
142717|NCT01699256|"~     The aim of this study is to evaluate whether an enhanced strategy of implementation of the~     new guideline will lower the number of patients getting referred to secondary care spine~     centres compared to a normal implementation strategy.~   "
142718|NCT01699243|"~     Machine learning techniques and algorithms originally developed for use in the field of~     robotics can be applied to continuous, noninvasive physiological waveform data to discover~     hidden, hemodynamic relationships. Newly developed algorithms can, in real-time: 1) predict~     cardiovascular collapse well ahead of any clinically significant changes in standard vital~     signs, 2) monitor and estimate fluid resuscitation needs, 3) estimate acute blood loss~     volume, and 4) estimate intracranial pressure. The investigators hypothesize that these same~     methods can be used to predict functional hypovolemia during regional anesthesia for labor or~     fetal intervention.~   "
142719|NCT01699230|"~     To show the existence of a atrial cardiomyocytes membranes modification in omega-3~     supplemented patients with coronary atherosclerosis.~   "
142720|NCT01699217|"~     The GIMEMA CML Working Party promotes a multicentre, observational, prospective study of CML~     patients treated frontline with NIL. Patients will be followed for 5 years. This study will~     help the definition of guidelines for the treatment of CML patients in early CP.~   "
142721|NCT01699204|"~     This experiment is designed to test the hypothesis that oxidative stress is responsible for~     changes in airway responsiveness in humans exposed to diesel exhaust.~   "
142722|NCT01699191|"~     Probiotics play an important role in preventing overgrowth of potentially pathogenic bacteria~     and maintaining the integrity of the gut mucosal barrier. The beneficial effects of~     probiotics have been previously studied in adult patients with IBS. Clinical studies show~     that patients meeting the criteria for diagnosis for IBS have greater probability for being~     affected by celiac desease if compared to controls without IBS. Since one of the causes~     attributed to the onset of IBS is the modified flora gut, it is interesting to determine the~     beneficial effects that probiotics may have on gastrointestinal symptoms in celiac disease~     patients. The goal of the present study is to determine whether oral administration of a~     probiotic mixture of Lactobacillus plantarum 14D-CECT 4528, Lactobacillus casei,~     Bifidobacterium breve Bbr8 LMG P-17501, Bifidobacterium breve Bl10 LMG P-17500 and~     Bifidobacterium animalis under randomized, double-blind, placebo-controlled conditions would~     improve symptoms of adult celiac patients with IBS.~   "
142723|NCT01699178|"~     The purpose of this one year extension (follow-up) study is to gather additional safety data~     in hypogonadal men treated with oral TU or AndroGel who have completed the 12-month Phase III~     study CLAR-09007.~   "
142724|NCT01699165|"~     The purpose of this study is to assess the effect of reducing exposure to allergens in~     patients with hay fever by means of a nasal filter.~   "
142725|NCT01699152|"~     This is a multi-center, open-label, dose escalation study.~   "
142909|NCT01696708|"~     The purpose of this project is to study brain energy profile evolution at different stages of~     the Huntington disease.~   "
142726|NCT01699139|"~     Supine positioning was reported to increase upper airway collapsibility, apnea frequency and~     duration. Positional therapy, designed to minimize supine sleep, was reported to be~     beneficial in the general sleep apnea population. As supine sleep is very common in stroke~     patients, positional therapy might also have therapeutic effects. Given differences between~     stroke patients with sleep apnea and the general sleep apnea patient, such as rolling~     ability, body mass index and daytime sleepiness, positional therapy results in the general~     population may not be applicable to the stroke patient.~      The effects of positional therapy in ischemic stroke patients with OSA have not been~     well-investigated. We therefore performed a pilot randomized, controlled, cross-over study to~     test the following hypotheses: (1) positional therapy reduces the amount of nocturnal supine~     positioning in patients with subacute ischemic stroke, and (2) severity of sleep apnea~     improves, as reflected by apnea-hypopnea index (AHI), during positional therapy. The~     tolerability of positional therapy over a 3-month period in patients with ischemic stroke was~     also evaluated.~   "
142727|NCT01699126|"~     study Hypothesis: We hypothesize that CPAP could effectively improve the endothelial~     dysfunction by anti-inflammatory effect in patients of OSA,and compare to the effect of~     statin.~   "
142728|NCT01699113|"~     The primary objectives are to find out in healthy subjects if:~        -  YF476 prevents the ECL-cell hyperplasia induced by repeated doses of rabeprazole - a~          proton pump inhibitor;~        -  YF476 also prevents rebound hyperacidity after stopping rabeprazole; and~        -  YF476 by itself causes neither ECL-cell hyperplasia after repeated doses nor rebound~          hyperacidity after stopping YF476.~      The secondary objectives are to:~        -  assess the safety and tolerability of YF476, alone and in combination with rabeprazole;~        -  compare the effects of YF476, alone and in combination with rabeprazole, on serum~          gastrin and plasma CgA and SST;~        -  assess if there is a pharmacokinetic interaction between YF476 and rabeprazole;~        -  assess the pharmacokinetics of repeat doses of YF476 by itself; and~        -  study the metabolism of YF476.~   "
142729|NCT01699100|"~     The purpose of this study was to determine if insoles with removable pegs could effectively~     reduce the plantar aspect pressure with the aid of in-shoe plantar pressure analysis for~     guidance of peg removal.~   "
142730|NCT01699087|"~     The purpose of this study is to evaluate the safety and effectiveness of the ALLEGRETTO WAVE~     EYE-Q excimer laser system for the reduction of myopia with or without astigmatism in~     subjects undergoing photorefractive keratectomy (PRK) treatment.~   "
142731|NCT01699074|"~     The study is a Phase-I like double blind randomized placebo controlled crossover design~     trial. The objective is to assess the dose response relationship on glycemic and vascular~     effects of an acutely administered Korean White Ginseng (KWG)(Panax C.A. Meyer) in~     individuals with metabolic syndrome or type 2 diabetes . Twenty seven subjects with Type 2~     Diabetes (Key inclusion criteria: HbA1c ≤8.5%)or metabolic syndrome (Key inclusion criteria:~     as defined by The US National Cholesterol Education Program Adult Treatment Panel III)will be~     recruited for the study.~   "
142732|NCT01699061|"~     The purpose of this study is to determine the effects of tivantinib on the QTc interval in~     patients with solid tumors~   "
142733|NCT01699048|"~     Minimally invasive revascularization of the left anterior descending artery followed by stent~     implantation versus percutaneous coronary intervention or coronary artery bypass in patients~     with multi-vessel coronary disease~   "
142734|NCT01699035|"~     Survey of survivor perspective on critical elements that either facilitate or inhibit return~     to work after a stroke. Critical elements are queried in areas of finances, stroke~     impairments, interpersonal support, therapeutic support, organization influences, work or job~     specific issues and psychological issues.~   "
142735|NCT01699022|"~     Cyclofem® is a monthly injectable contraceptive containing 25 mg of MPA and 5 mg of estradiol~     cypionate (E2C), a long acting ester of estradiol. The current study will assess the~     steady-state pharmacokinetics and pharmacodynamics of MPA and E2 after administration of~     Cyclofem® and will provide critical information to determine similar bioavailability of~     Cyclofem to Lunelle in women residing in the USA.~   "
142736|NCT01699009|"~     The purpose of the study is to assess whether, in individuals with migraines, a low-fat,~     vegan diet improves pain more effectively than a control supplement or a placebo. The~     principal measures are pain as measured by Visual Analog Scale (VAS) and the change in~     migraines frequency. The study duration is 36 weeks.This study also tests that a low fat,~     plant-based (vegan) diet free of foods commonly identified as triggers improves mood, using~     the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R), and the Beck~     Depression Inventory II (BDI-II).~   "
142737|NCT01698996|"~     Adult patients presenting to the emergency department with superficial cutaneous abscesses~     will be randomized after incision and drainage to standard care with wound packing or no~     packing to determine if there is a difference in the proportion of complications between the~     two groups.~   "
142738|NCT01698983|"~     Gluococorticoids are commonly prescribed to treat a number of diseases including the majority~     of inflammatory diseases. Despite considerable inter-personal variability in responses to~     glucocorticoids between asthmatics, an insensitivity rate of about 30% and the risk of~     adverse side effects of glucocorticoid therapy, no assay is currently performed to determine~     sensitivity in severe and non-severe asthmatics prior to treatment. The purpose of this study~     is to perform a whole blood ex vivo stimulation assay to interrogate known glucocorticoid~     receptor (GR) up- and down-regulated genes to indicate glucocorticoid sensitivity and compare~     the results between severe and non-severe asthmatics.~   "
142739|NCT01698970|"~     A double-blind, multicentre, stratified by centre, randomised, parallel study with two groups~     of adult patients operated on for Crohn's disease, to determine if oral ingestion of~     probiotics could prevent the appearance of Crohn's disease recurrent endoscopic ileo-colonic~     lesions 12 months after surgery. Patients will consume 900 mg/day of active product (N=56) or~     control product (N=56) during one year.~   "
142740|NCT01698957|"~     The purpose of this study is to detect if adding resistance to maternal blood flow from the~     arm will help increase the blood flow through the uterine arteries to the placenta and the~     baby.~   "
142741|NCT01698944|"~     This trial is conducted in Europe. The aim of this trial is to investigate the effect of~     growth hormone on left ventricle morphology and function (systolic and diastolic).~   "
142743|NCT01698918|"~     The purpose of this study is to find out if combining everolimus with letrozole is safe and~     has beneficial effects in postmenopausal women who have estrogen positive HER2 negative~     locally advanced or metastatic breast cancer. Additionally, this study aims to find out if~     everolimus plus exemestane is safe and has beneficial effects in women with estrogen positive~     locally advanced or metastatic breast cancer after treatment with everolimus plus letrozole.~     This study will also aim to find out if a mouth rinse can help reduce the severity of oral~     stomatitis, a common side effect of everolimus. This part of the study will be conducted only~     in countries where an alcohol free 0.5mg/5ml dexamethasone oral solution is commercially~     available.~   "
142744|NCT01698905|"~     A clinical research study to find out if it is safe to stop the drug nilotinib (Tasigna) in~     chronic myeloid leukemia (CML) patients. Patients who started treatment with imatinib~     (Gleevec) when they were first diagnosed with CML, then switched to nilotinib (Tasigna) for~     at least 2 years with the combined time on imatinib (Gleevec) and nilotinib (Tasigna) for at~     least 3 years and have very small amount of leukemia cells remaining after the nilotinib~     (Tasigna) treatment will qualify for the study.~   "
142745|NCT01698892|"~     Bronchoscopy is a technique which currently allows the investigation of many respiratory~     diseases (infections, neoplasia, inflammation…) as well as endobronchial therapeutic~     procedures.~      Good flexible bronchoscopy diagnostic practices suggest the use of anxiolytic premedication~     before endoscopy, but practices concerning the use of sedation further to the completion of~     the endoscopy are very heterogeneous.~      We thus propose to compare, during a randomize, controlled trial, respiratory tolerance to~     I.V. versus sublingual sedation in two groups of patients indergoing bronchoscopy~   "
142746|NCT01698879|"~     Acute myeloid leukemia (AML) is a neoplasm of immature hematopoietic cells (blasts) with~     altered ripening capacity. Due to excessive proliferation, the blasts displace normal~     hematopoietic cells and bone marrow failure appears. Leukemic cells also infiltrate~     extramedullary tissues.~      Following the standard chemotherapy treatment, the CR rate achieved is around 65-75% for all~     patients and 15% lower when considering only patients over 65 years. Modifications to the~     standard regimen consist of replacing the DNR for a cytotoxic one, modifying the dose of~     ara-C or adding a third drug.~      Gemtuzumab ozogamicin (Mylotarg ®) is an immunoconjugate between anti-CD33 antibody and a~     cytotoxic antitumor antibiotic, calicheamicin. Mylotarg ® antibody specifically binds to~     CD33, a sialic acid-dependent adhesion protein expressed in over 90% of LMA10. Mylotarg ®~     selectively transports the cytotoxic agent calicheamicin into leukemic cells and~     hematopoietic progenitors differentiated from the myelomonocytic line, while respecting the~     pluripotent hematopoietic stem cells. Calicheamicin is released only after the fixation of~     the antibody anti-CD33 and its internalization by the cell, after which binds to and damages~     the DNA.~      Mylotarg ® is approved in the U.S. for the treatment of CD33 positive AML in first relapse,~     for patients older than 60 years non-candidates for other intensive treatment modalities.~      Since the efficacy of Mylotarg ® is equivalent and its toxicity profile less than the~     conventional therapy, it is logical to conduct a phase II trial exploring the role of~     Mylotarg ® in the early stages of treatment of AML.~      Previous experience with gemtuzumab ozogamicin in relapsed patients led to its use combined~     with induction chemotherapy. The aim was to improve the CR rate reached with the latter and~     reduce relapse after achieving greater leukemic cytoreduction.~      Recent data from the HOVON group support that the administration of G-CSF before and during~     induction chemotherapy decreases the incidence of relapse in patients with AML, particularly~     those considered to have intermediate risk.~      Everything mentioned above justifies to investigate the combination of GO combined with~     chemotherapy with IDR and ara-C in standard 3x7 scheme and analyze the effect of~     sensitization with G-CSF in patients with AML de novo. If the treatment proposed here is~     effective and presents an acceptable toxicity it should be investigated.~   "
142747|NCT01698866|"~     The purpose of this study is to assess the seroconversion rate and the cellular immune~     response after vaccination against hepatitis B virus in patients with lymphoproliferative~     syndrome like chronic lymphocytic leukemia stade A and follicular lymphoma without of~     treatment criteria.~   "
142748|NCT01698853|"~     Femoro-femoral cardiopulmonary bypass with retrograde perfusion is needed for totally~     thoracoscopic cardiac surgery. one of the major complication of retrograde perfusion is organ~     hypoperfusion.~      Arterial blood gas analysis can help to detect hypoperfusion or hypoxia during retrograde~     perfusion. However,whether the arterial oxygenation status from different parts of the body~     are the same in the condition of retrograde perfusion have not been studied.~      The present study is aimed to determine if there is difference in the arterial oxygenation~     between peripheral arterial and aortic root during the period of retrograde perfusion.In~     addition, the impact of artificial ventilation on the difference of arterial oxygenation will~     also be investigated.~   "
142749|NCT01698840|"~     Transitional formulas (22 kcal/oz) are recommended for infants less than 35 weeks gestation~     at birth. However, few data are available related to follow-up of infants receiving these~     formulas who were 28-34 weeks gestation at birth.~      Primary hypothesis: Provision of supplemental vitamin D to a transitional formula will lead~     to higher serum 25-hydroxyvitamin D (25-OHD) levels and no infant with a serum 25-OHD less~     than 20 ng/mL when assessed at approximately 52 weeks post-menstrual age (PMA).~   "
142750|NCT01698827|"~     Multiple models of replacement tubes for percutaneous endoscopic gastrostomy are available in~     the market, however durability is variable. In a prospective randomized study, five~     commercial devices available in the market will be tested in 20 consecutive patients each.~     Tube performance will be observed during 6 months and durability will be assessed by~     Kaplan-Meier curves as well as Cox regression analysis.It is hypothesized that tube design~     and material will influence outcome.~   "
142751|NCT01698814|"~     The purpose of this study was to evaluate the ocular safety of an investigational ophthalmic~     solution in subjects 2 years of age and older with asymptomatic eyes when administered once~     daily in both eyes for up to 6 weeks.~   "
142752|NCT01698801|"~     To determine the efficacy of lenalidomide in combination with low-dose dexamethasone in~     Japanese subjects with previously untreated multiple myeloma.~   "
142819|NCT01697930|"~     This is a Phase I study. This study is the first time that a new experimental drug called~     18FFluoroglutamine, or F-Glutamine, is being used in people. F-Glutamine is a drug designed~     to be used with PET scanners that can 'see' where F-Glutamine goes in the body, after its~     injected. PET scanners are one of the kinds of scanners you normally find in a hospital~     radiology department. The researchers have found that tumors in animals absorb F-Glutamine.~     The researchers believe that scans with F-Glutamine might be able to find tumors in patients.~      This first in-human study is being done to see how long F-Glutamine lasts in the blood, when~     it is given to people in tiny amounts by an injection, and to see where F-Glutamine goes in~     the body. If the results of this trial are good, then the study doctors plan to use~     F-Glutamine in another trial to see if scans with F-Glutamine are better for finding tumors~     compared to the standard types of scans that doctors use.~   "
142753|NCT01698788|"~     This study is undertaken to determine effect of sustained release dexamethasone~     implant,Ozurdex in improving outcome of taut posterior hyaloid removal in patients with~     diabetic macular edema~      Diabetic macular edema constitute important cause of visual impairment in patients with~     diabetes.Focal/ grid laser photocoagulation is the standard of care in the management .~     Several adjuncts including intravitreal corticosteroids, Pegaptanib Sodium , Ranibizumab ,~     Bevacizumab are also been tried.In some patients inspite of multiple lasers or injections~     macular edema persists as a consequence overlying taut posterior hyaloid membrane which needs~     to be removed by vitrectomy. Visual improvement after vitrectomy is related to the duration~     of edema, as well as the extent of intraretinal lipid and vascular nonperfusion.Even after~     surgery some patients might need repeat intravitreal bevacizumab or triamcinolone injections~     to take care of residual macular edema.Intravitreal Triamcinolone Acetonide (TA), a water~     insoluble steroid, has been shown to reduce the retinal thickness and improve the visual~     acuity. However, recurrence of macular edema in patients who receive intravitreal TA is a~     major concern because of its short half life . In search for the ideal corticosteroid~     preparation, a Dexamethasone Posterior Segment Drug Delivery System (Dexamethasone DDS -~     Ozurdex®, Allergan Inc, Irvine, California) was recently developed which has generated new~     interest in this molecule. It is a sustained release intravitreal implant containing 700µg~     dexamethasone has been approved by the US-FDA (Food and Drug Administration) for treatment of~     macular edema in retinal vein occlusions. The present study introduces a novel concept of~     using intraoperative Ozurdex ® implant during taut posterior hyaloid removal and its effect~     in improving the surgical outcome~   "
142754|NCT01698775|"~     The purpose of this study is to evaluate the efficacy and safety of omarigliptin in~     participants with type 2 diabetes mellitus and moderate or severe chronic renal insufficiency~     or end stage renal disease on dialysis with inadequate glycemic control. The primary~     hypothesis of the study is that omarigliptin compared to placebo produces greater reduction~     in glycosylated hemoglobin (A1C) after 24 weeks.~   "
142755|NCT01698762|"~     The goal of this research study is to compare a booklet and a DVD for patients with knee~     osteoarthritis, osteoporosis, or rheumatoid arthritis.~   "
142756|NCT01698749|"~     This study is undertaken to determine the effect of intravitreal long acting dexamethasone~     implant,(Ozurdex®)in patients with diabetic macular edema.Diabetic macular edema is important~     cause of visual impairment in patients with diabetes mellitus. Focal/ grid laser~     photocoagulation is the standard of care in its management. Several adjuncts including~     intravitreal corticosteroids, Pegabtanib Sodium ,Ranibizumab, Bevacizumab, non-steroidal~     anti-inflammatory agents, corticosteroids, laser photocoagulation have been tried.~     Intravitreal Triamcinolone Acetonide (TA), a water insoluble steroid, has been shown to~     reduce the retinal thickness and improve the visual acuity. However, recurrence of macular~     edema in patients who receive intravitreal TA is a major concern as the patients need~     multiple repeat injections because of its short half life. A more potent steroid,~     dexamethasone has also been tried as an alternative to TA for macular edema; however, its~     short half life of only 3 hours prevents its clinical application. In search for the ideal~     corticosteroid preparation, a Dexamethasone Posterior Segment Drug Delivery System~     (Dexamethasone DDS - Ozurdex®, Allergan Inc, Irvine, California) was recently developed.~     Promising results have been shown in certain patients with retinal vein occlusions, uveitis~     receiving this intravitreal drug delivery system with improvement in visual acuity. The~     present study introduces a novel concept of using Ozurdex ® implant in patients with diabetic~     macular edema.~   "
142757|NCT01698736|"~     -  Recipient desensitization protocols were shown to enable successful living donor kidney~          transplantation across major ABO blood group barriers. For extracorporeal depletion of~          circulating ABO antibodies plasmapheresis or ABO blood group specific immunoadsorption~          (IA) are most commonly used.~        -  The efficiency of semiselective non-antigen specific IA in ABO-incompatible~          transplantation is currently not well established. One potential drawback of~          semiselective adsorbers could be an incomplete elimination of IgM.~        -  This randomized controlled crossover trial was designed to clarify whether membrane~          filtration, as an adjunct to semiselective IA, can substantially enhance elimination of~          IgM.~   "
142758|NCT01698723|"~     The term Acute on chronic liver failure (ACLF) describes a clinical entity characterized by~     an acute and rapid deterioration of liver function in a patient with previously~     well-compensated liver disease owing to the effects of a precipitating event. In this~     condition two insults act simultaneously, one being the preexisting liver injury (chronic~     liver disease) and the other acute injury which is responsible for the acute decompensation.~     HEV being a major factor responsible for this clinical entity and has a very high mortality~     rate. Ribavirin being a safe drug and has been shown to inhibit the replication of HEV, can~     be an important drug in the treatment of these patients. Therefore the present study is~     designed to study the impact of Ribavirin in reducing the mortality due to HEV related ACLF.~   "
142759|NCT01698710|"~     This research study is a pilot study. In this pilot study we are testing the safety of a~     procedure. Investigational means that the Albumin bound paclitaxel (Abraxane) is still~     being studied and that research doctors are trying to find out more about it. It also means~     that the FDA has not approved Abraxane injection for your type of medical condition.~     Treatment of pancreatic cysts often requires follow-up imaging studies and surgical resection~     of the cysts. As part of standard medical care, you will be undergoing a diagnostic~     endoscopic ultrasound guided fine needle aspiration (EUS-FNA) in order to evaluate type of~     the cyst. During the EUS and just after the cyst fluid aspiration, you will undergo the~     injection of the drug into the cyst cavity if your cyst is thought to be cancerous or~     precancerous. Cyst fluid will be analyzed for further diagnosis.~   "
142760|NCT01698697|"~     This trial is conducted in Africa. The aim of this trial is to determine if a new formulation~     (U200) of insulin aspart containing 200 U/mL is bioequivalent to that of a marketed insulin~     aspart formulation (U100).~   "
142761|NCT01698684|"~     The objectives of this study are to examine the therapeutic effects of two doses of avanafil~     after dosing in men with erectile dysfunction~   "
142762|NCT01698671|"~     The purpose of the study is to assess the performance and safety of the InterGard Synergy~     vascular graft.~   "
142763|NCT01698658|"~     This clinical trial studies ultrasound tomography using SoftVue in diagnosing women with~     breast cancer. New diagnostic procedures, such as ultrasound tomography using SoftVue, may~     help find and diagnose breast cancer.~   "
142764|NCT01698645|"~     National multicenter, prospective, observational study in cancer patients with chronic~     background pain and breakthrough pain to whom PecFent® has been prescribed under pragmatic~     condition by a specialist in the treatment of cancer pain conditions.~      • Study objectives include assessment of early treatment satisfaction.~   "
142765|NCT01698632|"~     The purpose of this study is to learn more about the appearance and behavior of~     benign-looking adnexal masses.~        -  Benign-looking means that when viewed here by ultrasound it has the appearance of~          looking not harmful or not malignant.~        -  Adnexal refers to the 'adnexa', the space in the female pelvis on either side of the~          uterus (or where the uterus used to be if you previously had a hysterectomy). The adnexa~          includes, but is not limited to, the ovaries and the fallopian tubes.~        -  Masses refers to a variety of structures, including but not limited to:~             -  ovarian cysts that are fluid filled sacs within or attached to an ovary~             -  ovarian tumors that can be solid tissue or a combination of cysts and solid tissue~             -  hydrosalpinges that are fluid collections in the fallopian tube~      Many women have what appear to be benign adnexal masses. Many times, removal of the masses~     with surgery is not necessary. Often surgery is performed unnecessarily, for fear that these~     masses could be cancer. There is not much information available for doctors to know how and~     when to follow these masses, or which ones will become cancer.~      This study will combine information from centers all around the world regarding the behavior~     of all types of benign adnexal masses. The aim of this study is to develop decision tools for~     doctors to know the best way to treat these masses in order to improve the detection of~     ovarian cancer while at the same time reduce the number of unnecessary operations.~   "
142766|NCT01698619|"~     We use a new technology (Nexfin from BMEYE-Inventive Hemodynamics) to monitor Cardiac Output,~     Blood Pressure, Fluid Responsiveness, Pulse Oximetry, Hemoglobin Concentration, Oxygen~     Delivery in Climbers during their process of acclimatization on a expedition to Mount~     Aconcagua.~   "
142767|NCT01698606|"~     In this 3-phase study, following an initial small-scale (phase 1) feasibility trial, the aim~     of phase 2 of the project is to investigate whether a community-based, 12-month intervention~     for overweight and obese preschool children 2-6 years of age and their families will be~     effective in reducing the participants' degree of overweight (BMI z-score) and in improving~     quality of life.~      In the final phase (phase 3), participating children will be randomized to either receiving a~     multidisciplinary lifestyle intervention during the first 6 months (treatment arm), or 6~     months later (control or wait list arm), in order to generate more robust effectiveness data.~     Participants will receive an additional free 6-month YMCA membership while participating in~     the study.~   "
142768|NCT01698593|"~     No one knows how long bupivacaine finger blocks last. Many use bupivacaine with and without~     epinephrine, but no one knows how the epinephrine affects the duration of the block. We also~     don't know how long the pain part of the block lasts, which is what counts.~      The goal of the study is to determine the duration of action of bupivacaine digital nerve~     blocks (with and without epinephrine) on finger temperature and the sensory modalities of~     pain, touch, and pressure. 2 ml of bupivacaine 0.5% with and without epinephrine will be~     injected at the base of each ring finger on the palm surface. At the end of 1 hr, 6 hrs, 12~     hrs, 14 hrs and each additional hour, patients will use an insulin lancet to measure pain,~     the Semmes Weinstein monofilament test to measure light touch and pressure and a body surface~     thermometer to measure finger temperature. The time for the finger to return to normal~     sensation and temperature will be measured.~   "
142769|NCT01698580|"~     This study is a clinical trial designed to evaluate the effectiveness of a multifactorial~     falls prevention program in reducing the rate of falls.~      A multifactorial falls prevention program consisting of an individualized medical management~     of the modifiable risk factors, a progressive on-site body balance exercise plus a home-based~     exercise program, an educational/behavioral intervention and a fall prevention booklet will~     reduce the number of falls and fall rates when compared with usual care.~   "
142770|NCT01698567|"~     The purpose of this study is to discern whether supplementation of Antithrombin III will~     decrease coagulation and inflammation associated with cardiopulmonary bypass in infants~     undergoing cardiac surgery.~   "
142771|NCT01698554|"~     This study will evaluate the safety and efficacy of bimatoprost solution formulation A~     compared with bimatoprost solution 0.03% (LATISSE®) and vehicle in the treatment of eyelash~     hypotrichosis (inadequate eyelashes).~   "
142772|NCT01698541|"~     Test bioequivalence of generic tacrolimus (Tacni), using original tacrolimus (Prograf) as~     comparator, in elderly (>60 yr) renal transplant recipients~   "
142773|NCT01698528|"~     The purpose of this study is to determine if using a diabetes management technology system,~     including a tablet computer, to track diabetes care and communicate with a clinician coach (a~     doctor or nurse from the Joslin Clinic) makes starting and adjusting insulin easier and safer~     for people with type 2 diabetes. Hypothesis: The use of a diabetes management technology~     system with a clinician coach helps more individuals starting basal insulin achieve better~     glycemic control with less hypoglycemia compared with standard clinical practice at Joslin~     Diabetes Center.~   "
142774|NCT01698515|"~     The objective of this study is to evaluate the effect of Tumor Necrosis Factor (TNF)~     inhibition on oral parameters in patients with RA and to examine changes in levels of~     proinflammatory cytokines in serum, gingival crevicular fluid (GCF), and saliva at an early~     time point (6-8 wk) and a later time point (14-16 wk) after the initiation of therapy in~     relation to concomitant assessment of Rheumatoid arthritis (RA) and oral clinical variables.~      The purposes of the study are to:~        1. Determine if oral periodontal parameters are affected by TNF inhibition;~        2. Examine relationships between periodontal variables and RA variables with TNF~          inhibition;~        3. Determine if there may be potential early response markers of clinical RA response seen~          using ultrasensitive analysis of oral or serum cytokines.~   "
142820|NCT01697917|"~     The purpose of this study is to find out more about differences of the quality of life in~     patients undergoing total gastrectomy or proximal gastrectomy for adenocarcinoma of~     esophagogastric junction. To find a better reconstruction for patients who received total~     gastrectomy.~   "
142846|NCT01697540|"~     1. Written informed consent must be obtained before any study specific procedures are~          undertaken.~        2. The process of the experiment (brief describe) The patients must come back for follow~          during 4 to 12 weeks after starting the new therapy. The investigators will follow the~          patients' lipid profile and any side effects and stop the observation till 36 months~          after starting the new therapy. The serum level of HIV-VL, CD4, GOT, GPT, triglyceride,~          cholesterol, HDL-cholesterol, and LDL-cholesterol will be checked every 3 months. The~          patients' chart and all data will be delinked to protect the patients' right and~          privacy.~   "
142775|NCT01698502|"~     It is well known that continuous physical exercise leads to a number of changes in the body.~     Maximal oxygen uptake; the heart's pumping ability and muscle mass and strength increases.~     Also the metabolism adapts: The ability to oxidize fat increase and the insulin sensitivity~     in primarily in muscle, but also in the liver increase.~      Also endocrine glands adapts according to the level of physical activity. It is known that in~     healthy, younger people the insulin secretion from the pancreas after administration of sugar~     consumed orally or given directly into a vein, is significantly lower in trained individuals~     compared with untrained. This change does, however, not only apply to glucose, as also~     stimulation by the amino acid arginine, shows the same pattern.~      It seems plausible that the endocrine glands/cells adapts to the level of physical training,~     but this has not yet been investigated.~      The gastrointestinal tract is the birthplace of a variety of hormones. One group of these is~     called incretin hormones. They stimulate the glucose dependant insulin secretion in the~     pancreas and affect hunger/satiety. Whether the incretin production and thus their~     concentration in the blood is regulated by physical training is unknown.~      Obese and patients with type 2 diabetes, has, in contrast to well-trained, decreased insulin~     sensitivity. As a consequence their (type 2 diabetics, at least early in their disease~     course) meal stimulated insulin release is greater than in healthy, normal weight~     individuals. This in spite of the fact that the incretin effect is reduced in obese people~     and patients with type 2 diabetes compared to healthy, normal weight.~      Whether physical training affects both the secretion of incretins and the incretin effect has~     not yet been studied.~      The purpose of this study is to investigate whether incretin hormones in physical~     well-trained young men have a changed effect on insulin secretion from the pancreas compared~     to untrained young men. A difference may indicate that the body's endocrine glands adapts to~     training mode.~      The investigators hypothesis is that incretin hormones have a decreased effect on the glucose~     dependant insulin release in physically trained persons and thus results in a lower insulin~     release at any given plasma glucose level.~   "
142776|NCT01698489|"~     Closer examination of granular lipid data in a large population offers numerous opportunities~     to generate new knowledge, ranging from studies examining concordance between commonly used~     lipid parameters to phenotypic characterization of rare or extreme disorders of lipid~     metabolism, opening possibilities to better personalize future treatment of abnormal blood~     lipids.~      STUDY POPULATION:~      The Very Large Database of Lipids (VLDL) includes adults and children who were clinically~     referred for a Vertical Auto Profile (VAP).~      LIPID MEASUREMENTS:~      The VAP test (VAP Diagnostics Lab, Birmingham, Alabama, USA) directly measures cholesterol~     concentrations of low density lipoprotein, very low density lipoprotein, intermediate density~     lipoprotein, high density lipoprotein, their subfractions, and lipoprotein(a). Triglycerides~     in the database are directly measured using the Abbott ARCHITECT C‐8000 system (Abbott Park,~     Illinois, USA). Lipid distributions in the database closely match those from the~     population-representative National Health and Nutrition Examination Survey (NHANES).~      STUDY PROCEDURES:~      This database was investigator-initiated. Only de-identified data reach the investigational~     site. The first data harvest was in 2011 and the second in 2016. The master database is~     housed at The Johns Hopkins Hospital in Baltimore, Maryland, and maintained by Drs. Jones and~     Martin. Only electronic data, and not blood samples, are sent to Hopkins. The academic~     investigators have unrestricted access to study data, take responsibility for the accuracy of~     analyses, and have authority over manuscript preparation and submission.~      VARIABLES:~      The variables currently in the VLDL database are testing date, age, sex, fasting/nonfasting,~     and components of the VAP test. From these primary variables, many additional variables were~     derived for inclusion in the master database. Other analytes measured by validated assays in~     subsets of the VLDL database include apolipoprotein B (apoB), apolipoprotein A1 (apoAI),~     high-sensitivity C-reactive protein (hsCRP), homocysteine, uric acid, insulin, hemoglobin~     A1c, 25-hydroxy vitamin D, cystatin C, lipoprotein-associated phosphatase (Lp-PLA2), thyroid~     stimulating hormone (TSH), free T3 and T4, pro-brain natriuretic peptide (pBNP), direct~     bilirubin, creatine phosphokinase (CPK), creatinine and other components of the comprehensive~     metabolic panel, magnesium, and phosphate.~      DATABASE ORGANIZATION:~      In the current database, each record represents a unique patient. The 1st available VAP test~     for each patient is included. To meet the needs of a variety of research questions, we are~     prospectively planning to organize harvest 2 data into 3-year interval datasets (i.e., VLDL~     2006-2008, 2009-2011, VLDL 2012-2014, etc), a summation dataset (first VAP test for each~     patient), serial lab dataset (patients who have had repeated testing), and ancillary datasets~     (subsets of patients with coexisting data on other measures such as apolipoproteins, vitamin~     D, etc).~      INDIVIDUAL STUDIES:~      Individual VLDL studies are based on a priori hypotheses or aims with statistical analysis~     plans (SAPs) peer-reviewed prior to execution. In the expandable Detailed Description~     section below, the VLDL investigators will periodically register individual studies and~     update their status here.~   "
142777|NCT01698476|"~     The aim with study is to provide adjunctive therapy with vitamin D and phenylbutyrate~     together with standard anti-tuberculosis treatment to significantly improve clinical recovery~     among patients with untreated, active pulmonary tuberculosis.~   "
142778|NCT01698463|"~     Falls and fractures are a leading cause of death and disability in the older adult~     population. The consequences of falls and fractures contribute substantially to health care~     costs and can have a significant negative impact on the quality of life of the individual.~     Exercise has been studied as an option to reduce fracture risk and prevent falls though~     improving balance and muscle strength. The prevention of falls is important, as a history of~     falls is strongly predictive of suffering another. Those who are at a high risk of fracture~     or falling require a patient specific assessment and individualized exercise prescription~     that is tailored to their needs. This kind of program may not be typically available within~     the community and at a low cost. These individuals may experience difficulty when trying to~     engage in exercise due to barriers such as a lack of transportation, and a lack of knowledge.~     As the first point of contact with the health care system for many family doctors are in the~     ideal position to deliver exercise advice to their patients. However, a lack of time and~     specialized skills in prescribing exercise make this difficult for many of them. As a result,~     family health teams who provide interdisciplinary patient centered care are becoming popular.~     In this model the care is shared and provided by the most appropriate team member (e.g.~     doctor, nurse, exercise specialist). Additionally, many exercise interventions do not include~     a behavior change aspect, which may be an important component when trying to get individuals~     to engage in a new health behavior like exercise. Therefore the purpose of this project is to~     assess the feasibility of implementing a tailored exercise program to those at high risk of~     falls or fractures over the age of 65 in a primary care setting using an interdisciplinary~     model of care that is based on a health behaviour change model.~   "
142779|NCT01698450|"~     The aim of this study is to asses the efficacy and the clinical safety of the transcranial~     magnetic resonance guided high intensity focused ultrasound system ExAblate 4000, InSightec~     Ltd. for functional neurosurgery in the treatment of movement disorders. The treatments to be~     conducted in this study are non-invasive, i.e. without opening the skull, and will create~     microthalamotomies in specific target areas such as thalamus, subthalamus and pallidum. The~     data obtained in this study will be used to evaluate the basic safety aspects of this new~     treatment technology and will serve as a basis for the clinical introduction of MR-guided~     ultrasound neurosurgery.~   "
142780|NCT01698437|"~     Focused Ultrasound Focused ultrasound is an attractive method for non-invasive thermal~     ablation of soft tissue tumors. Treatment begins by acquiring a series of MR images of the~     target organ. The physician then identifies a target volume in the MR images and delineates~     the treatment contours on the images. Therapy planning software calculates the parameters~     required to effectively treat the defined target volume. During the treatment an ultrasound~     transducer generates and focuses ultrasound energy to a focal point, called a sonication. The~     sonication raises the tissue temperature within a well-defined region to a degree, which~     causes thermal coagulation. MR images acquired during sonication provide a quantitative,~     real-time temperature map of the target area to confirm the location of the sonication and~     the size of the coagulated region. The sonication process is repeated at multiple adjacent~     points to cover the entire prescribed treatment volume.~   "
142781|NCT01698424|"~     Our goal is to develop and test a new imaging technique to help scientists study sarcopenia,~     the process by which muscle becomes weaker with age. This imaging technique uses Positron~     Emission Tomography/Computed Tomography (PET/CT) scanners to measure the ability of muscle to~     synthesize new protein. This ability to build new muscle protein is known as the Protein~     Synthesis Rate, and is thought to decline as people age and to contribute to muscle~     weakening. We are researching this technique in order to develop a tool to help scientists~     and physicians better understand how muscle ages and how it changes based on some stimulus,~     such as when people eat a high protein meal, exercise, or take muscle-building drugs. If our~     research is successful, it will provide a new method for scientists and physicians to test~     the effectiveness of new drugs and other treatments for muscle weakness. The study will look~     for healthy woman between the ages of 65 and 80.~   "
142782|NCT01698411|"~     Several epidemiological studies in large cohorts suggest a strong association between sleep~     duration, complaint of insomnia and risk of hypertension.These findings suggest an important~     role of sleep quality in development of hypertension. Principal limitations of these studies~     are the cross-sectional study design, self-report sleep duration and poor measurement of~     blood pressure. The investigators propose to study an insomniac population with complete~     evaluation of quality and quantity of sleep, associated to complete hemodynamic measurement~     of hypertension.~   "
142783|NCT01698398|"~     The purpose of the study is to examine the relationship between working capacity (peak oxygen~     consumption) and pump speed of continuous flow left ventricular assist devices (CF-LVADs)in~     heart failure patients. The hypothesis is that it is possible to increase peak oxygen~     consumption by incrementally increasing CF-LVAD pumpspeed during exercise.~      The study population will consist of severe heart failure patients with CF-LVADs treated at~     The Heart Centre of Copenhagen University Hospital Rigshospitalet.~   "
142784|NCT01698385|"~     OVERALL OBJECTIVES:~        1. To assess the efficacy of a diet and exercise intervention before and/or during~          pregnancy in the prevention of GDM and its fetal complications in women with high~          diabetes risk.~        2. To assess the cost-effectiveness of a diet and exercise intervention in the prevention~          of GDM from a socio-economic point of view. To find out whether the intervention can be~          used to reduce health care costs due to GDM and T2DM.~        3. To determine the long-term effectiveness of the above-mentioned lifestyle intervention~          in the reduction of T2DM incidence among women with prior GDM and their offspring~      STUDY SUBJECTS Group 1: Women planning pregnancy with a history of diet/insulin-treated GDM~     or BMI >30 kg/m2. N= 250 + 250.~      Group 2: Women in early pregnancy with a history of diet/insulin-treated GDM or BMI >30~     kg/m2. N= 250 + 250~      METHOD The Finnish multi-center randomized controlled intervention trial started in the~     maternity hospitals of Helsinki and Uusimaa District Area 1/2008 and in the South-Karelia~     Central Hospital in Lappeenranta in 9/2008. 1000 women at high GDM risk will be recruited.~     Half of the subjects are randomized into the intervention group and the other half act as~     controls receiving only standard antenatal care in addition to the laboratory tests taken and~     questionnaires administered by the RADIEL study.~      The active intervention arm of the study will be carried out in a structured, standardized~     manner by diabetes nurses and nutritionists specifically trained for their tasks. The~     intervention includes:~        1. Structured visits to diabetes nurse every 3 months before and during pregnancy as well~          as at 6 weeks, 6 and 12 months post partum. Visits include e.g. structured counseling on~          diet and exercise, setting of specific goals, follow-up of achievements, laboratory~          tests and measurements~        2. Structured group visits to nutritionist at the moment of enrollment in the study, at the~          beginning of pregnancy as well as at 6 and 12 months post partum. Additional individual~          visits are booked if needed.~        3. Services of physical activity advisors are provided by the study subjects' cities of~          residence free of charge to all who wish to receive extra counseling on exercise. If~          exercise goals are not met, study subjects book an appointment with the physical~          activity advisor.~      LIFESTYLE TARGETS: 1.Weight: A weight loss of 5-10% before pregnancy if BMI > 25 and/or~     limited weight gain during the first two trimesters in pregnancy if BMI > 30. 2.Exercise: A~     minimum of 30 min. of exercise 5 times per week or 50 min. 3 times per week of moderate~     intensity exercise (Borg 11-15). Daily household and/or transportation physical activity.~     3.Diet: Increased intake of vegetables, legumes, fruits and berries, whole grain and fiber,~     low-fat dairy, vegetable fats; and use of plate model. Total energy intake: 1600-1800~     kcal/day, with 40-50 E% carbohydrates, 30-40 E% fats, 20-25 E% protein.~      MEASUREMENTS of maternal variables:~      AT THE MOMENT OF ENROLMENT TO THE STUDY, and every 3 months before pregnancy:~      (1) Waist circumference, blood pressure, pulse, weight, height (2) i.e. 2-hour OGTT,~     fP-insulin, fP-glucose, , GHbA1c, lipids, P-hCRP, P-IL-6, S-A1Glypr, leptin. (3) Background~     questionnaire (4) 15-D-questionnaire: health-related quality of life. (7) Food diary (2+1).~     Exercise diaries daily for one week.~      PREGNANCY At the end of each trimester: (1) The same tests and measurements as in~     pre-pregnancy period. 2h-OGTT at H10-14 and at H24-28. (2) Questionnaire, 15-D questionnaire,~     EDPS (=Edinburgh post-partum depression scale) questionnaire for screening mood disorders at~     H10-13. (4) Food diaries (2+1), and exercise diaries daily for one week at H10-13 and H34-36.~      POST PARTUM PERIOD (Groups 1-2) At 6 weeks, 6 and 12 months post partum: (1) The same~     follow-up tests and measurements as at the beginning. Lipids checked only at 12 months post~     partum. (2) 2-hour OGTT 6 weeks and 12 months post partum (3) Questionnaires at all visits.~     (5) Food and exercise diaries at 12 months post partum.~      MEASUREMENTS of child's variables at birth~      (1) weight (2) height (3) head circumference (4) From delivery records: Mode of delivery,~     Apgar scores, any perinatal complications, operations, need of neonatal intensive care and~     length of hospital. (3) Laboratory tests from cord blood.~      TIMETABLE Recruitment started in February 2008 and ended in autumn 2011 when about 800~     subjects had been recruited to the study. Intervention will continue until 2014 (including~     pre- and postpartum periods). Long-term follow up of both mothers' and children's cohorts~     starts in 2014 and has been planned to continue up to 10 years postpartum. Data analysis~     starts in autumn of 2013 and results will be reported from 2014 onwards in international~     peer-reviewed journals.~   "
142785|NCT01698372|"~     This study will test the effectiveness of negative pressure wound therapy (using the VAC~     Prevena device, KCI Canada Inc.) applied to the saphenous vein harvest site after Coronary~     Artery Bypass Grafting (CABG). When initiated immediately after surgery, this intervention~     may decrease the incidence of wound infection and non-infectious wound complications. It may~     decrease wound discomfort and improve mobility and functional recovery of the leg.~   "
142786|NCT01698359|"~     Muscle-invasive bladder cancer affects over 3,000 new patients in the UK each year and~     radiotherapy comprises a key part of the treatment pathway for many of them. Bladder~     radiotherapy in the UK involves delivery of radiation to the entire bladder volume and aims~     to deliver a high dose to the bladder while sparing nearby healthy organs (e.g. the bowel).~     Unfortunately, large variations in bladder shape and volume are observed throughout treatment~     that compromise the probability of a positive outcome for the patient, either by increasing~     the risk of side-effects or by reducing the likelihood of adequately treating the disease.~      In recent years, the implementation of 'adaptive' bladder radiotherapy strategies has~     increased. These techniques allow modification of the treatment based on the observed~     variations in bladder shape and volume. However, these strategies often rely on daily X-ray~     imaging of the patient prior to treatment, which is time-consuming and associated with a~     small risk of inducing a cancer in the patient.~      This study will evaluate the potential of a commercially available ultrasound probe for use~     as an alternative to X-ray scanning during treatment for these patients. The study will also~     aim to compare the likelihood of reducing side-effects and successfully treating the disease~     for the different adaptive strategies that are used around the world.~   "
142787|NCT01698346|"~     Despite good vaccination coverage, included in national immunization programs in developed~     countries, the number of reported pertussis cases is rising, also in very young infants.~     Current immunization strategies fail to protect infants too young to be immunized with the~     licensed vaccine. Different strategies are possible to close the gap of susceptibility~     between the loss of maternal antibodies and protection by vaccination. The main aim of the~     present study is to measure the influence of an adult pertussis booster in pregnant women, on~     the titer and duration of maternal antibodies in their infants. Early humoral immunity will~     be assessed and the influence on vaccine response of the infant measured. The present study~     offers the opportunity to have new insights in neonatal immunological mechanisms against~     pertussis and a better understanding in strategies to protect infants against pertussis.~   "
142788|NCT01698333|"~     Adrenal suppression effects of corticosteroids are among the most important safety concerns~     for this group of products. This study is designed to determine the adrenal effects of the~     investigational formulation of 122-0551 and characterize the steady state pharmacokinetics of~     the formulation.~   "
142789|NCT01698320|"~     The purpose of this study is to evaluate the safety of Albuterol Spiromax® over 52 weeks~     during two dosing periods: (1) a 12-week, double-blind, placebo-controlled QID dosing period~     followed by (2) a 40-week, open-label PRN dosing period, and to evaluate Albuterol Spiromax®~     device performance through the life of the device during the study.~   "
142790|NCT01698307|"~     Assess if the implementation of an enhanced treatment algorithm will improve the management~     Crohn's Disease compared to a conventional Step-care approach.~   "
142791|NCT01698294|"~     This randomized clinical trial studies biomarkers in post-menopausal women receiving~     flaxseed. Studying samples of blood, urine, and feces in the laboratory from participants~     receiving flaxseed may help doctors understand the effects of flaxseed on biomarkers.~   "
142792|NCT01698281|"~     This is a therapeutic exploratory Phase 2 study evaluating AEZS-108 compared to standard~     single agent cytotoxic chemotherapy (SSCC) as measured by the median time of progression-free~     survival (PFS) in patients with chemotherapy refractory triple negative (ER/PR/HER2-negative)~     LHRH-R positive metastatic breast cancer.~   "
142793|NCT01698268|"~     Study measures the difference in pain after hernia &/or hydrocele repair based on site of~     local anesthesia injection.~   "
142794|NCT01698255|"~     This randomized pilot study will test the feasibility of a behavioral intervention for late~     life depression. Enrolled participants will receive 9 weeks of a specialized form of~     psychotherapy we call ENGAGE or standard of care psychotherapy. ENGAGE is a stepped care~     psychotherapy based on what is currently known about older adults' response to depression~     interventions. Stepped care is a model of treatment that starts with the minimum effective~     therapeutic techniques first, and then based on how well people respond to treatment,~     additional therapeutic techniques are added until individuals recover from their depression.~     The treatment components of ENGAGE were selected to match the most common problems seen in~     older adults with depression. They include instructing the participant in basic problem~     solving techniques and encouraging re-engagement in rewarding activities.~      Participants will be depressed, older adult clients of Westchester Jewish Community Services~     or outpatient research subjects recruited by the Cornell Institute of Geriatric Psychiatry.~     In addition to receiving therapy, study participants will also undergo research assessments~     at the beginning of the study and then at weeks 6 and 9.~   "
142795|NCT01698242|"~     The purpose of this study is to test whether a culturally sensitive self-management (SM)~     intervention, compared to an education only control, will reduce all-cause hospital days in~     patients with mild to moderate heart failure and household income less than $30,000 per year.~   "
142796|NCT01698229|"~     The purpose of this study is to obtain cerebrospinal fluid from healthy children already~     undergoing a lumbar puncture procedure at New York Presbyterian Hospital, to act as healthy~     controls when compared to children with late infantile neuronal ceroid lipofuscinosis~     (LINCL), a fatal neurodegenerative disease.~   "
142797|NCT01698216|"~     The aim of this study is observation of effectiveness and side effect of patients with~     schizophrenia who will switch the antipsychotics from risperidone long acting injection to~     paliperidone palmitate.~   "
142831|NCT01697735|"~     Statins are cholesterol-lowering medications that are often prescribed for patients with high~     cholesterol and who are at risk for cardiovascular disease (CVD). But there are many patients~     whose hyperlipemia are not well controlled. If investigators are simply doubling the statins,~     that only 6% of the benefit can be received. And it often has significant side effects in~     elder patients. Several studies have suggested that the use of berberine can effectively~     lower blood lipids. The chemical structure and mechanisms of drug is clearly, and the side~     effects are seldom, the price of berberine is very cheap. The purpose of this study is to~     observe the therapeutic effects of combination of statins and berberine on the patients with~     hyperlipemia whose level of the lipid are not well controlled when only using statins.~   "
142852|NCT01697462|"~     This prospective observational study will evaluate the safety and efficacy of Xeloda~     (capecitabine) administered in monotherapy in patients with metastatic colorectal cancer.~     Patients will be followed until disease progression or unacceptable toxicity occurs.~   "
142798|NCT01698203|"~     Objective: Epidural analgesia is the gold standard for post-thoracotomy pain relief but is~     contraindicated in certain patients. An alternative is continuous wound catheter analgesia.~     We will investigate whether ropivacaine, administered through a wound catheter placed by the~     surgeon, will reduce postoperative pain. Methods: In a randomized double-blind study, adult~     patients with a wound catheter placed by the thoracic surgeon after thoracotomy will be~     randomly assigned to receive through this catheter, either a 0.1 mL/kg bolus of 0.75%~     ropivacaine, followed by a continuous infusion of 0.2% ropivacaine at 10 mL/h for 48 h, or~     saline at the same scheme of administration. Patients will also benefit from~     patient-controlled analgesia with intravenous morphine (bolus 1 mg, lockout time 7 min),~     paracetamol, and nefopam. The primary endpoint will be total morphine consumption. Secondary~     endpoints will be pain intensity on a visual analog scale at rest and on coughing and side~     effects during the first 48 postoperative hours. Surgeons, anesthesiologists, and all the~     nurses and caring staff involved in this study will be blinded. Solutions of saline and~     ropivacaine will be prepared identically by the central pharmacy, without any possible~     identification of the product.~   "
142799|NCT01698190|"~     The purpose of this study is to determine if fine needle aspiration or fine needle biopsy is~     more efficacious and cost-effective than the other while maintaining diagnostic accuracy in~     the setting of solid gastrointestinal lesions.~   "
142800|NCT01698177|"~     Seasonal influenza (flu) is a significant and sometimes serious health issue in the U.S. The~     Centers for Disease Control (CDC) estimates that over 200,000 people are hospitalized in the~     U.S each year related to the flu. Public health campaigns advocate widespread vaccination for~     the flu, and especially for high risk people. People with cancer are high risk, with an~     increased risk of developing complications from the flu, such as pneumonia, bronchitis, or~     worsening of other medical conditions. As part of their vaccination campaign, the CDC~     strongly encourages inpatients to be vaccinated prior to hospital discharge. Accordingly,~     Stony Brook Hospital has enacted a policy that mandates screening all hospital inpatients for~     vaccination prior to discharge. While physicians or patients can opt not to vaccinate, the~     default is to proceed. Surgical oncologists have several concerns about vaccinating their~     patients after major surgical procedures. Patients with cancer have impaired immunity, and~     the ability of our patients to mount an effective immune response to the vaccine is unclear.~     Conversely, due to their immunocompromised state, our patients may be more susceptible to~     complications from the vaccine, such as influenza-like-illness (ILI), or have higher rates of~     postoperative complications due to the additional immune challenge of the vaccine. Previous~     studies have evaluated the flu vaccine in patients receiving chemotherapy, or after organ~     transplantation, but the combination of cancer and major surgery remains unstudied.~      This is a collaborative study with Infectious Diseases and Microbiology to evaluate the~     response to the flu vaccine in patients with pancreatic or gastric cancer, soft tissue~     sarcoma or peritoneal surface disease (i.e. carcinomatosis from appendiceal or colon~     cancers). Patients will be randomly selected to receive the vaccine either 2 weeks~     preoperatively or postoperatively at the time of discharge. Serum antibody response, rates of~     ILI and post-op complications will be analyzed. The long term goal of this study is two-fold:~     to determine the optimal time to vaccinate this group of patients in relation to their~     surgery, and to improve compliance with vaccination.~   "
142801|NCT01698164|"~     This study is to evaluate the benefit/risk of hormone replacement treatment among early~     menopausal women in China. This is a multi-centre, random, prospective study.~   "
142802|NCT01698151|"~     This is an observational study in primary care aiming to validate biomarkers for chronic~     obstructive pulmonary disease (COPD).~   "
142803|NCT01698138|"~     This study is a double blind, randomized, placebo controlled trial to explore the effect of~     early treatment with Onabotulinumtoxin A in patients with acute complete motor spinal cord~     injury (SCI) on the development of neurogenic detrusor overactivity (NDO). A total of 20~     patients will be randomized to intra-detrusor injection of 300 U Onabotulinumtoxin A in 30 ml~     NaCl 0.9 % or placebo with 30 ml NaCl 0.9 %. Bladder biopsies will be obtained in the same~     procedure. The treatment will be repeated after three months. All included patients will be~     evaluated with urodynamic examinations. Follow-up is 12 months after the first treatment. The~     primary endpoint of the study is development of NDO.~   "
142804|NCT01698125|"~     The purpose of this study is to study aspects of autonomic cardiovascular control and the~     level of stress hormones and inflammatory markers in saliva or serum, in elderly patients~     exposed to elective, major abdominal surgery, with or without postoperative delirium, to~     explore the hypothesis that delirium may be the result of aberrant stress responses.~   "
142805|NCT01698112|"~     This project is a clinical intervention trial that will determine the role of a functional~     food, flaxseed, on the control of blood glucose levels in people with pre-diabetes. People~     with pre-diabetes have high blood glucose levels since their cells do not respond to insulin~     as they should. Over time, people with pre-diabetes may progress to type 2 diabetes and have~     increased risk for heart and kidney diseases. Although the long-term complications associated~     with type 2 diabetes are well-recognized, clinicians and researchers are now realizing that~     some long-term damage to the body, especially the heart and circulatory system, may already~     be occurring during pre-diabetes. Consequently, clinicians are recognizing that glucose~     control, through diet, exercise and, if necessary, medications, is as important for people~     with pre-diabetes as it is for people with type 2 diabetes.~      Standard treatments for pre-diabetes are glucose control through diet, exercise, and drugs. A~     possible treatment that could be added to the standard treatments is intake of flaxseed. Few~     studies have looked at the effect of flaxseed intake on glucose control and those that have~     enrolled people with type 2 diabetes. To date, no studies have reported flaxseed's affect on~     controlling blood glucose in people with pre-diabetes. Therefore, more research is needed to~     determine if flaxseed is an effective means of controlling glucose levels in people with~     pre-diabetes.~      This study will help determine whether or not eating modest amounts of flaxseed every day~     will improve blood glucose and insulin levels in overweight or obese men and postmenopausal~     women with pre-diabetes. It will also show if flaxseed intake will reduce the degree of~     inflammation they are experiencing.~      If flaxseed consumption does help control blood glucose levels in people with pre-diabetes~     and reduce the degree of inflammation they are experiencing, it may help prevent or delay~     their progression to type 2 diabetes.~   "
142806|NCT01698099|"~     Hyperbilirubinemia is reported to be a positive predictor in diagnosing perforated~     appendicitis. Therefore we analysed the diagnostic accuracy of serum bilirubin in~     discriminating between perforated and simple/no appendicitis.~      Methods:~      All consecutive patients undergoing appendectomy for suspected appendicitis from May 2009 to~     August 2011 were analysed. Primary endpoint was the diagnostic accuracy of serum bilirubin~     levels to detect perforated appendicitis.~   "
142832|NCT01697722|"~     This study will compare the effectiveness, cost-effectiveness and direct healthcare costs of~     asthma management in patients with evidence of persistent asthma following an increase in~     asthma therapy in the form of either an increased dose of inhaled glucocorticosteroids (ICS)~     using extrafine hydrofluoroalkane-beclometasone dipropionate (HFA-BDP) via pressurised~     metered-dose inhaler (pMDI) or breath-actuated inhaler (BAI), or a change to combination ICS~     plus long-acting bronchodilator (LABA) therapy using fixed combinations (fluticasone~     propionate / salmeterol [FP/SAL] or budesonide / formoterol [BUD/FOR]) or separate pMDIs and~     BAIs.~   "
142847|NCT01697527|"~     This phase II trial will examine whether genetically reprogramming a patient's disease~     fighting white blood cells may build an immune response to kill cancer cells that express the~     NY-ESO-1 protein. In this study, this genetic therapy will be given during a stem cell~     transplant along with a vaccine therapy. The vaccine will be made using the NY-ESO-1 protein~     and may help to stimulate the engineered immune response to tumor cells.~   "
142807|NCT01698086|"~     Impaired standing balance, fatigue and abnormal eye movements are common problems in persons~     with MS. These complaints are related to advanced disability and decreased quality of life~     for persons with MS. Researchers from the University of Colorado and the Rocky Mountain~     Multiple Sclerosis Center (RMMSC) at the Anschutz Medical Campus have recently completed and~     published a research study that showed an exercise program consisting of balance and eye~     movement training, referred to as a vestibular rehabilitation program, was very effective in~     improving self-reported fatigue and standing balance in persons with MS. This initial study~     was the first to have proven that this type of exercise program is able to improve both of~     these potentially devastating complaints.~      The investigators from this initial study have partnered with other well-established~     researchers from the University of Colorado Anschutz Medical Campus and the Rocky Mountain~     Multiple Sclerosis Center (RMMSC) at the Anschutz Medical Campus to advance our knowledge of~     the effect of vestibular rehabilitation for persons with MS. Using the findings from the~     initial study, the investigators propose to conduct a larger study specifically identifying~     persons with MS who have brain lesion involvement in areas that control balance and eye~     movements. Primarily, the current study will determine if those individuals who have~     involvement in these areas of the brain improve more in balance and fatigue compared to those~     who do not following participation in a vestibular rehabilitation program. Additionally, the~     investigators will test if study participants who have abnormal eye movement control, will~     improve their eye movement control following the training program. For persons with MS,~     impaired eye movements can lead to a considerable decline in health status, further~     illustrating the importance of the research plan to study this important factor.~      The investigators believe that greater improvements in balance and fatigue are possible from~     a longer treatment, and that participants who have brain lesion involvement in areas that~     help control balance and eye movements will benefit greater than those who do not. This~     information is important to determine who is more likely to benefit from a vestibular~     rehabilitation program. Additionally, the researchers will be able to measure changes in eye~     movement control, providing valuable insight into the reasons for the program's~     effectiveness.~   "
142808|NCT01698073|"~     Youth who participate in the Circle of Life (COL) program will report less sexual risk taking~     behavior compared to youth who do not receive the program.~   "
142809|NCT01698060|"~     The purpose of the study is to determine the safety and tolerability of ND1.1, an adjuvanted~     adenoviral-based avian influenza vaccine, when delivery is targeted to the ileum, using a~     radio controlled capsule. The secondary objective is to evaluate the immune response~     (cellular and humoral) of two doses of ND1.1 oral vaccine.~   "
142810|NCT01698047|"~     The purpose of this study is to build a scientific evidence base for the training and~     delivery of a depressive symptoms education program, developed by local community members,~     called a Resiliency Class (RC). The RC has strong elements of Cognitive Behavioral Therapy~     and is designed to be delivered as a psycho-educational class by non-professionals to improve~     mood. Depressive symptoms are common, especially in low-income, minority communities.~     Depressive symptoms that don't meet DSM-IV criteria for Major Depression still carry a~     significant amount of disability. Interventions that address sub-threshold depressive~     symptoms have been noted to result in a decreased likelihood of depression and diminished use~     of mental health services. Few interventions using a health education / health promotion~     focus are designed to be delivered by non-professionals to address individuals with mild to~     moderate depressive symptoms in low income, minority communities. This project will take~     place in the Centinela Valley, which roughly corresponds to Service Planning Area (SPA) 6 or~     South Los Angeles (SLA). This single-blind, randomized trial will utilize a wait-list control~     design where half of the participants enrolled in the study will be randomized to the~     Resiliency Class (7 sessions) and half will go to a wait-list control condition where they~     will receive 2 case management calls and referrals to social services. We propose to screen~     1500 clients to detect about 450 participants with depressive symptoms (endorsed one item on~     the PHQ-2). We plan to enroll 400 participants, 200 in the resiliency class and 200 in the~     wait-list control condition. Primary outcomes measures will include depressive symptoms,~     function, and measures of resiliency. We will assess these measures at baseline and at 3~     months after completion of the Resiliency Class or wait-list condition. After the completion~     of the first round of classes, we will conduct a preliminary analysis of the impact of the~     resiliency classes versus the wait-list control case management calls on depressive symptoms.~     If the resiliency classes improve depressive symptoms more than the wait-list control, we~     will offer wait-list controls access to the resiliency classes and then disseminate the~     resiliency class through trainings.~      We hypothesize that the resiliency classes will lead to greater reductions in client~     depressive symptoms than the wait-list case management calls in the randomized trial of this~     project.~   "
142811|NCT01698034|"~     This study tested whether getting youth engaged in helping others (volunteering) would~     benefit youth's physical health. 106 predominantly minority and low socioeconomic status~     (SES) youth were randomized to either volunteer weekly with elementary school children in~     after school programs or to a wait-list control group. The investigators hypothesized that~     cardiovascular risk markers of C-reactive protein (CRP), interleukin-6 (IL-6), total~     cholesterol, and body mass index (BMI) would be lower at post-intervention (4 months after~     baseline) in the volunteer group compared to the control group. The investigators also~     hypothesized that the intervention might work through pathways such as reducing negative~     mood, improving self esteem, and increasing prosocial behaviors (empathy, altruism).~   "
142812|NCT01698021|"~     The new assay of troponins T (highly sensitive troponins) detects concentrations much lower~     than before. Few data are currently available on their kinetics during acute coronary~     syndrome, especially in regard to the correlation with CK MB. The aim of the present study is~     to describe the kinetic of highly sensitive troponins in acute coronary syndrome, to~     correlate it with the concentration of CK MB, and possibly to evaluate their prognostic value~     with respect to infarct size .~   "
142813|NCT01698008|"~     Type 1 or type 2 diabetes mellitus subjects who know how to operate and own an iPhone, are~     between the age of 19 to 75, and are on a basal/bolus insulin regimen will be included in the~     study. Subjects will be randomized to two groups - iPhone versus standard of care and seen in~     our clinic at an initial/baseline and three month clinical visit. The control group will~     e-mail, fax, or call their blood glucose log results once a month for an insulin regimen~     adjustment through verbal communication with a certified diabetic educator once a month as is~     already implemented at the Diabetes Center. This group will be compared to the intervention~     group who will submit their blood glucose log results through an iPhone mobile application,~     called Diabetes Doctor, once a month for an insulin regimen adjustment by a physician with a~     text message response. The two groups will have their HbA1c, hypoglycemic events, blood~     glucose dispersion compliance, quality of life, usability and satisfaction with the use of a~     mobile application will be assessed at each visit with surveys.~   "
142814|NCT01697995|"~     The objectives of this study are to determine the:~        1. Diagnostic value of stress induced RV changes on Lexiscan stress MPI as compared to~          Exercise stress MPI in predicting a significant CAD.~        2. Prognostic value of stress induced RV changes on Lexiscan stress MPI in predicting~          adverse short-term and long-term clinical outcomes after the index test.~   "
142815|NCT01697982|"~     Hope is important to palliative home care patients. Our research team has developed a Living~     with Hope Program that has been found to increase hope and quality of life in older persons~     with advanced cancer.~      The investigators want to know if this program increases hope and quality of life for all~     palliative home care patients (all ages, all diagnosis). Thirty palliative home care patients~     and their care partners will participate in this pilot study to evaluate the study procedures~     and the living with hope program.~   "
142816|NCT01697969|"~     The purpose of this study is to descriptively evaluate the corneal structures of allergic~     conjunctivitis patients.~   "
142817|NCT01697956|"~     The purpose of this study is to compare the effect of 6 weeks of treatment with~     beclomethasone dipropionate (BDP) nasal aerosol versus placebo on HPA-axis function, as~     assessed by 24-hour serum cortisol weighted mean, and to evaluate the safety and tolerability~     of BDP nasal aerosol, in subjects 6 to 11 years of age with perennial allergic rhinitis.~   "
142821|NCT01697904|"~     Preterm infants are born with immature lungs and often require help with breathing shortly~     after birth. This traditionally involves administering 100% oxygen. Unfortunately, delivery~     of high oxygen concentrations leads to the production of free radicals that can injure many~     organ systems. Term and near-term newborns deprived of oxygen during or prior to birth~     respond as well or better to resuscitation with room air (21% oxygen) compared to 100%~     oxygen. However, a static concentration of 21% oxygen may be inappropriate for preterm~     infants with lung disease.Purpose of the study is to investigate if preterm neonates where~     resuscitation is initiated with 21% fiO2 and adjusted to meet transitional goal saturations~     (Limited oxygen strategy or LOX) would have less oxidative stress as measured by the~     oxidative balance ratio of biological antioxidant potential/total hydroperoxide compared to~     infants where resuscitation is initiated with pure oxygen and titrated for targeted~     saturations of 85-94% (Traditional oxygen strategy or TOX). Secondary outcomes of interest~     included need for other delivery room resuscitation measures, respiratory support and~     ventilation/oxygenation status upon neonatal intensive care unit (NICU) admission, survival~     to hospital discharge, bronchopulmonary dysplasia and other short-term morbidities.~   "
142822|NCT01697891|"~     Study hypothesis: ALTENS techniques, administered within the first 3 months after radiation~     completion, can improve radiation-induced dysphagia and associated symptoms in head and neck~     cancer patients. This beneficial effect is mediated by the reduction of chronic inflammatory~     response of swallowing musculature to radiation, consequently a reduction in muscle fibrosis.~      Primary study objective: To evaluate the effectiveness of ALTENS in relieving~     radiation-induced dysphagia. Eating Assessment Tool (EAT-10) scores will be used for this~     primary study endpoint.~   "
142823|NCT01697878|"~     The investigators propose to compare two different treatments, continuous positive airway~     pressure (CPAP) versus breathing of atmospheric pressure, in subjects with obstructive sleep~     apnea (OSA)recovering from weight loss surgery in the post anesthesia care unit (PACU). WE~     hypothesize that subjects with OSA will have a higher Apnea-Hypopnea Index (AHI) with~     desaturation and the investigators expect that post-operative CPAP treatment in the PACU will~     significantly improve the AHI and therefore improve patient safety in the PACU. The~     investigators also hypothesize that subjects with OSA have a greater decrease in oxygen~     saturation in response to opioid administration by patient-controlled opioid analgesia (PCA).~   "
142824|NCT01697865|"~     The overall objective of this study is to compare the clinical benefit and safety of two~     different surgical techniques of primary reverse total shoulder arthroplasty for the~     treatment of shoulder pseudoparalysis from chronic rotator cuff disease with associated teres~     minor dysfunction. The first surgical technique includes a concomitant latissimus and teres~     major transfer (transfer group) and the second technique does not include a concomitant~     latissimus and teres major transfer (control group).~   "
142825|NCT01697852|"~     The study is a cluster randomised trial to compare the effectiveness of indoor residual~     spraying (IRS) combined with the use of long lasting insecticidal nets (LLINs) with the~     effectiveness of LLINs alone for preventing malaria infection and morbidity. The primary~     outcome measure is prevalence of parasitaemia and anaemia in children aged 0.5-10 years,~     measured in cross sectional surveys. Secondary outcomes include relative population density~     for each mosquito vector species, malaria transmission as measured by entomological~     inoculation rates (EIR) by mosquito vector species, monitoring of resistance markers~     including kdr, and user acceptability of LLINs compared with IRS.~      Findings from this study are expected to inform decision making so that resource utilization~     can be optimised.~   "
142826|NCT01697839|"~     This is a prospective study investigating the relationship between vitamin D and peripheral~     neuropathy (PN) among multiple myeloma (MM) patients treated with either bortezomib or~     thalidomide. The study consists of a screening period of up to 14 days, followed by a single~     assessment visit to evaluate vitamin D levels, incidence and severity of PN, neuropathic~     pain, and markers of depression. Patient charts will also be utilized to assess the frequency~     of skeletal-related events.~   "
142827|NCT01697826|"~     Randomized, Parallel Group, Active Controlled Trial to compare effectiveness and tolerability~     of 2 different vaginal formulations containing 200mg clotrimazole and clindamycin phosphate~     equivalent to 100mg clindamycin for 3 days in women clinically diagnosed to have infective~     vaginitis.~   "
142828|NCT01697800|"~     Head and neck squamous cell carcinoma (HNSCC) is a lethal solid malignancy with 5 year~     survival estimates of approximately 50%, and is associated with a high rate of systemic~     immune impairment as well as evasion of a tumor specific immune response. Preclinical and~     clinical data have shown that PDE5 inhibitors (tadalafil) can be used to augment immune~     function in HNSCC patients through inhibition of the cancer-induced myeloid derived~     suppressor cells (MDSCs).~      A multi site phase II, randomized, prospective, biomarker endpoint trial to determine optimum~     timing and design of PDE5 antitumor immunotherapy (tadalafil) in conjunction with~     conventional therapy for HNSCC.~      40 patients with biopsy proven HNSCC will be randomized to receive tadalafil (n=25) or~     placebo (n=15) for at least 10-14 days before starting conventional therapy and continuing~     until 90 days after completion of conventional therapy. Tumor-specific T cell responses will~     be assessed using HNSCC cell lines, in blood collected before initiation of tadalafil/placebo~     and at 60 and 90 days after completion of conventional therapy. Number and function of MDSC~     and Treg cells will be assessed before and at 60 and 90 days after completion of conventional~     therapy. Prevnar 13® vaccine will be administered 10-14 days after commencing~     tadalafil/placebo (before conventional therapy begins) and again at 60 days after completion~     of conventional therapy. Vaccine-specific responses assessed at 60 and 90 days~     post-conventional therapy will be used to measure the ability of tadalafil to augment immune~     response to vaccine.~   "
142829|NCT01697787|"~     This is a two-arm study aiming at recruiting 150 patients to assess the efficacy of~     Amodiaquine-Artesunate (ASAQ) and Artemether-Lumefantrine (AL) in patients with a microscopy~     positive diagnosis of malaria in Nanoro, Burkina Faso and assess the performance of the Rapid~     Diagnosis Tests (RDTs) compared to the microscopy.~   "
142830|NCT01697761|"~     The purpose of this study is to determine whether acupuncture or moxibustion therapies are~     effective in the treatment of active Crohn's disease. meanwhile, we are aim to observe the~     content of Inflammatory factors and Neurotransmitter before and after acupuncture and~     moxibustion therapy.~   "
142833|NCT01697709|"~     Despite a benign public perception, marijuana use disorders represent a significant public~     health problem. The development of safe and effective pharmacotherapies for marijuana~     dependence is an important unmet public health need. Quetiapine, an effective atypical~     antipsychotic that acts by blocking serotonin type 2A, dopamine type 2, histamine type 1, and~     adrenergic receptors, is a promising treatment for substance use disorders. In animal models,~     quetiapine blocks the enhancement of reward by cocaine, which is likely due to its actions on~     both dopamine and non-dopamine neurotransmission. Clinical studies of quetiapine have shown~     benefit for the treatment of alcohol and cocaine use disorders.~      Conceptually, the clinically prominent effects of quetiapine, namely sedation, anxiolysis,~     mood stabilization and appetite stimulation, are a good match for the symptoms of marijuana~     withdrawal. Most importantly, an open-label dose-finding study of quetiapine for the~     treatment of marijuana dependence conducted by our research group determined that quetiapine~     was well-tolerated and associated with reductions in marijuana use indicating that it is a~     promising agent deserving of further study in marijuana-dependent outpatients.~      The proposed research project is a randomized double-blind placebo-controlled clinical trial~     to evaluate the efficacy of quetiapine for the treatment of marijuana dependence over a~     12-week period. All participants will receive Medical Management, a medication adherence~     focused psychosocial intervention that facilitates compliance with study medication and other~     study procedures, promotes abstinence from marijuana and other substances, and encourages~     mutual-support group attendance. All participants will receive voucher incentives for~     compliance with study visit attendance, returning study medication bottles, and completing~     other study procedures, with the objective of achieving a highly compliant sample. The goal~     of this phase II clinical trial is to build on our promising open-label pilot study results~     and examine the efficacy of quetiapine on participants' marijuana consumption under~     placebo-controlled double-blind conditions using an abstinence-initiation model, where~     participants will be using marijuana regularly at study entry, reduce their use, and then~     achieve abstinence. The specific aims of the projects are to determine whether quetiapine is~     superior to placebo in 1) reducing marijuana use and 2) achieving abstinence.~   "
142834|NCT01697696|"~     The purpose of the study is to provide long term safety data of NVA237. This study will~     assess the safety and tolerability of a single dose strength of NVA237.~   "
142835|NCT01697683|"~     This study will add to the current knowledge and literature on the ability of an oral~     lactobacilli preparation to return the vaginal flora to a normal state in pregnant women. The~     results will potentially serve as the basis for a multi-centre Phase III randomized clinical~     trial to determine the efficacy of this treatment in preventing preterm birth.~   "
142836|NCT01697670|"~     Objectives:~      Primary: The primary study objective is to determine a clinical response as assessed by the~     Mayo score to low dose PDT in patients with moderate to severe active distal UC.~      Secondary: The secondary study objectives are to assess the effect on inflammation and the~     safety and tolerability of low dose PDT in patients with moderate to severe active distal UC.~      This is a multicenter, open phase II study that will enroll a maximum of 20 eligible patients~     with moderate to severe active distal UC. The first 10 eligible patients, the first cohort,~     will receive PDT at a 10 Joule per square centimetre (J/cm2) dose intensity. If no clinical~     response is observed in the first 7 eligible patients, the study will be stopped due to lack~     of efficacy. If at least 1 clinical response is observed in the first 7 patients, the first~     cohort will be completed to a total of 10 eligible patients~        -  Trial with medicinal product~   "
142837|NCT01697657|"~     This trial is conducted in Africa, Europe and Oceania. The aim of this trial is to~     investigate whether insulin detemir combined with insulin aspart compared to NPH insulin~     combined with insulin aspart could reduce the frequency of hypoglycaemic episodes whilst~     maintaining the same degree of glycaemic control subjects with type 1 diabetes.~   "
142838|NCT01697644|"~     This trial is conducted in Europe. The aim of this trial is to assess and compare the~     efficacy and safety of two dose levels of somatropin over a long period (till final height is~     reached). This trial is an extension to trials GHRETARD/BDP/14/NL (a 2-year initial trial)~     and GHRETARD/BPD/20/NL (a 2-year extension trial).~   "
142839|NCT01697631|"~     This this trial is conducted in Europe. The aim of this trial is to compare glycaemic control~     of biphasic insulin aspart 30 (BIAsp 30) alone or combined with insulin aspart(IAsp) in~     patients previously treated with conventional Biphasic Human Insulin 30/70.~   "
142840|NCT01697618|"~     This trial is conducted in Europe. The aim of this trial is to investigate pharmacokinetics,~     pharmacodynamics and safety of biphasic insulin aspart 30 in subjects with type 2 diabetes.~   "
142841|NCT01697605|"~     This study will evaluate safety and tolerability to determine the Maximum tolerated dose~     (MTD) and/or Recommended dose (RD).~   "
142842|NCT01697592|"~     This study will examine the safety and efficacy of the addition of omarigliptin in Japanese~     participants with type 2 diabetes mellitus who have inadequate glycemic control on~     diet/exercise therapy and oral antihyperglycemic agent monotherapy.~   "
142843|NCT01697579|"~     The purpose of this study was to determine the appropriate dosing regimen of fosaprepitant,~     when administered with ondansetron (with or without dexamethasone), for the prevention of~     CINV in children from birth to <17 years of age. Fosaprepitant is a prodrug to aprepitant.~     All participants who completed the randomized Cycle 1 could elect to receive open-label~     fosaprepitant during optional Cycles 2-6.~   "
142844|NCT01697566|"~     The goal of this clinical research study is to learn about the effects of metformin and/or a~     program called lifestyle intervention on the endometrium (inner lining of the uterus) in~     post-menopausal women who are also obese (both are risk factors for endometrial cancer).~     Researchers also want to learn how insulin levels will be affected by metformin, diet and/or~     exercise.~      Metformin is designed to treat both diabetes and insulin resistance. Insulin resistance is a~     condition in which the body makes insulin but does not use it properly. It is often referred~     to as pre-diabetes. Many people with insulin resistance have high levels of both sugar and~     insulin in their blood at the same time, which have been reported in patients with~     endometrial cancer.~      In this study, metformin will be compared to a placebo. A placebo is not a drug. It looks~     like the study drug but is not designed to treat any disease or illness. It is designed to be~     compared with a study drug to learn if the study drug has any real effect.~      Lifestyle intervention is made up of a series of in-person sessions where you meet with a~     coach to discuss strategies for losing weight and ways to increase physical activity. It also~     consists of materials designed to help you lose weight and will offer opportunities for~     supervised exercise.~   "
142845|NCT01697553|"~     The growth of the elderly population is associated with the autonomy failure and the increase~     of dependence problems. Fall incidents are the third cause of chronic disablement in older~     persons and are one of the major risk factors for entering in dependence.~      The recent progress in home technologies and medical care are opportunities to search how to~     apply these tools to reduce and prevent falling at home.~      The purpose of this study is to evaluate the cost effectiveness of simple home automation~     pack coupled to teleassistance service for preventing home falls in frail elderly population.~      1200 patients will be enrolled and randmosied within two arms:~        -  home with automation pack coupled to teleassistance service~        -  home without this technology~   "
142855|NCT01697423|"~     The incidence of cartilage pathology has grown due to the ageing population, and the increase~     in sports participation and its associated trauma. The aim of the treatment of symptomatic~     osteoarthritis consists in reducing pain and improving the knee function in order to limit~     the sport, professional and social negative impact in the youngest patients.~      The symptomatic treatment of knee osteoarthritis associates painkillers and non steroid anti~     inflammatory drugs (nsad). In case of ineffectiveness of the oral drugs intra articular~     injections are proposed.~      Intra articular injections of hyaluronic acid are recommended by the American College of~     Rheumatology and the European League against Rheumatism for the treatment of knee~     osteoarthritis. Nevertheless their efficacy remain non predictable in patients so as the~     duration of clinical improvement which does not exceed 6 months.~      The articular cartilage has a limited capacity for self-repair due to the low mitotic~     activity of chondrocytes and its avascularity.~      Platelet-rich plasma is a natural concentrate of growth factors: PDGF, TGF b, IGF-1, FGF and~     the cytokines, liberated by platelet degranulation. The influence of these growth factors in~     the cartilage repair is being widely investigated in vivo and in vitro. These factors could~     stimulate the chondral reparation via a neovascularization, a collagen synthesis and an~     activation of the chondrocytes.~      The hypothesis is that the intra articular injection of PRP, with its capacity to enhance~     articular cartilage repair, could be a therapeutic alternative to hyaluronic acid in the~     treatment of knee osteoarthritis resisting the oral drugs.~      Material and methods: We intend to conduct a comparative, monocentric prospective randomized,~     double-blind study on 80 patients with symptomatic knee osteoarthritis to compare the results~     of 2 intra articular treatment: platelet-rich plasma and hyaluronic acid.~   "
142856|NCT01697410|"~     The purpose of this study is to evaluate the efficacy of terlipressin for treating septic~     shock.~   "
142857|NCT01697397|"~     A feasibility study for monitoring and recording gastrointestinal (GI) myoelectric activity~     in subjects with suspected or diagnosed irritable bowel syndrome (IBS) and reports of GI pain~     and asymptomatic subjects without IBS and GI pain.~   "
142858|NCT01697384|"~     Objective was to evaluate the efficacy and safety of the histrelin acetate subdermal implant~     (originally versus Lupron Depot-3 Month) in male patients with advanced prostate cancer~     during 52 weeks of treatment with the implant. After consultation w/ FDA, design was modified~     to eliminate the Lupron arm and continued the study as an open-label non-randomized study.~      Primary endpoint was testosterone suppression, as assessed by the percent of patients whose~     testosterone indicated chemical castration levels (<=50 ng/dL) through 52 weeks of treatment~     with an implant.~   "
142859|NCT01697371|"~     Local control of hepatic metastases appears to be a major determinant of overall survival.~     However, many patients are not suitable for resection due to medical or surgical reasons.~     Therefore, there is an important role for a treatment that can provide the equivalent of~     tumor resection with minimal morbidity. Stereotactic body radiotherapy (SBRT) delivers an~     ablative regimen of highly focused external beam radiotherapy that targets one or more~     discrete extracranial lesions. Published reports using SBRT to treat liver metastases have~     shown actuarial local control rates ranging from 50-100% with higher doses associated with~     better local control.~      In patients with metastatic liver disease, aggressive local therapy using modern radiotherapy~     techniques are promising and project to have a substantial role in the treatment of~     metastatic liver cancer to treat unresectable disease. The dosimetric advantage of proton~     therapy may lead to improved clinical outcomes with less morbidity, however, there is no~     clinical data to confirm this assertion. We thus propose a phase I study to determine the~     feasibility and safety of stereotactic body proton therapy in patients with liver metastases~     followed by a phase II study to determine the efficacy of such treatment on local control.~   "
142860|NCT01697358|"~     The purpose of this study is to compare the effectiveness of spinal cord stimulation (SCS)~     using the Medtronic Specify® 5-6-5 multicolumn surgical lead plus optimal medical management~     (OMM) versus OMM alone in patients suffering from predominant low back pain due to failed~     back surgery syndrome (FBSS).~   "
142861|NCT01697345|"~     It is well documented that women who have breast cancer may experience a decrease in quality~     of life and sexual functioning due to side effects from adjuvant endocrine therapy, typically~     aromatase inhibitors (AIs). Women taking AIs are more likely to report unpleasant urogenital~     and vaginal symptoms due to the physiologic suppression of estradiol. This treatment can~     impair sexual functioning and cause a decreased sexual health quality of life.~      At the present time, there are no Food and Drug Administration (FDA) approved medications for~     the vulvovaginal or sexual side effects related to the use of AIs. The lack of treatment~     options is concerning because the number of women diagnosed with breast cancer continues to~     increase; their longevity, also, continues to increase with the use of newer adjuvant~     chemotherapies. Local health care practitioners have observed that the benefits of vaginal~     testosterone for sexual health in breast cancer survivors are similar to the benefits of~     vaginal estrogen in women without breast cancer.~      The purpose of this study is to evaluate the impact of using a daily compounded vaginal~     testosterone cream for 4 weeks (28 days) on breast cancer survivor's reported experience of~     vulvovaginal symptoms accompanying the use of AIs and their associated quality of life and~     sexual functioning.~   "
142862|NCT01697332|"~     The overall objectives of our study are to determine the capabilities of hyperpolarized 129Xe~     MRI to measure lung function and its potential to sensitively detect pulmonary disease and~     its progression in COPD. We hypothesize that measurement of alveolar surface area, septal~     thickness, and capillary transit time measured with hyperpolarized 129Xe will correlate~     better with quality of life measures in COPD subjects than traditional diagnostic measures~     such as spirometry and Computed Tomography.~   "
142863|NCT01697319|"~     The primary objective of this study is to evaluate the effect of 2.0 mg/kg/week BMN 110 in a~     patient population that has limited ambulation, in a period of up to 144 weeks.~   "
142864|NCT01697306|"~     To our knowledge, there are no comparative studies on bacillus Calmette-Guerin (BCG) and~     intravesical chemotherapy addressing quality of life (QoL) issues. The aim of this study was~     to prospectively evaluate and compare the QoL of intermediate-risk non-muscle-invasive~     (NMIBC) patients treated with BCG or gemcitabine.~   "
142865|NCT01697293|"~     This phase I/II trial studies the side effects and the best dose of triciribine phosphate~     when given together with paclitaxel, doxorubicin hydrochloride, and cyclophosphamide and to~     see how well they work in treating patients with stage IIB-IV breast cancer. Triciribine~     phosphate may stop the growth of tumor cells by blocking some of the enzymes needed for cell~     growth. Drugs used in chemotherapy, such as paclitaxel, doxorubicin hydrochloride, and~     cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing~     the cells, by stopping them from dividing, or by stopping them from spreading. Giving~     triciribine phosphate with paclitaxel, doxorubicin hydrochloride, and cyclophosphamide may be~     a better treatment for breast cancer.~   "
142866|NCT01697280|"~     This study aims to assess if pictorial messages promoting routine immunization during~     supplementary campaigns for oral polio vaccine in areas with poor DTP3 vaccine coverage can~     improve immunization rates. A cluster randomized trial design in low literature populations~     will be used.~   "
142867|NCT01697267|"~     Rituximab is now established as an effective drug for anti-neutrophil cytoplasmic antibody~     (ANCA) vasculitis following major European and US trials reported in 2010. After a time, its~     effect wears off and the disease can return. This occurs in at least half of patients within~     2 years of receiving Rituximab. A preliminary study in Cambridge has suggested that repeating~     rituximab every six months stops the disease returning and is safe.~      The RITAZAREM trial will find out whether repeating rituximab stops vasculitis returning and~     whether it works better than the older treatments, azathioprine or methotrexate. It will also~     tell us how long patients remain well after the repeated rituximab treatments are stopped,~     and if repeated rituximab is safe. We should also learn useful information about the effects~     of rituximab on quality of life and economic measures. The trial results will help decide the~     best treatment for future patients who have their vasculitis initially treated with~     rituximab.~      RITAZAREM aims to recruit patients with established ANCA vasculitis whose disease has come~     back 'relapsing vasculitis'. All patients will be treated with rituximab and steroids and we~     anticipate that most will respond well. If their disease is under reasonable control after~     four months, further treatment with either rituximab (a single dose ever four months for two~     years) or azathioprine tablets will be chosen randomly. The patients in the rituximab and~     azathioprine groups will then be compared. Patients will be in the trial for four years.~      The study has been designed by members of the European Vasculitis Study group (EUVAS) and the~     Vasculitis Clinical Research Consortium (VCRC). It will include 190 participants from 30~     hospitals in Europe, the USA, Australia and Mexico.~      RITAZAREM is being funded by Arthritis Research UK, the U.S. National Institutes of Health~     and by Roche/Genentech.~   "
142868|NCT01697254|"~     This CARRA Registry study will create a foundational database for rheumatic diseases of~     childhood using a novel informatics infrastructure developed as part of the larger clinical~     project. The creation of a CARRA-wide informatics infrastructure will enable efficient,~     observational, disease-related data capture across all CARRA sites for pediatric rheumatic~     diseases. The CARRA Registry study will demonstrate the feasibility of expanding to more data~     intensive registries for observational studies, comparative effectiveness research,~     pharmaceutical clinical trials and translational research.~   "
142869|NCT01697241|"~     The aim of this trial is to test the hypothesis that patients with severe hip osteoarthritis~     postpone time to hip replacement surgery following participation in a patient education and~     supervised exercise program when compared to patients receiving patient education alone.~   "
142870|NCT01697228|"~     The investigators are conducting a prospective cross-over study to evaluate the effects of~     vitamin D supplementation on diabetes control and the pro-inflammatory markers involved in~     microvascular complications in adolescents with Type 1 Diabetes. The investigators expect to~     see a significant improvement in glycemic control and a reduction of serum pro-inflammatory~     markers in adolescents with Type 1 Diabetes and vitamin D deficiency or insufficiency, who~     are treated with vitamin D.~   "
142871|NCT01697215|"~     To evaluate the ability of the SonarMed AirWave to provide clinicians with information that~     enables them to confirm continuous proper placement of the endotracheal tube. This initial~     study is prospective, observational, looking at CXR results, and comparing those to AirWave~     system output data.~   "
142872|NCT01697202|"~     To investigate how the fatigue vary over time in persons with rheumatoid arthritis (RA) and~     which factors that may influence the fatigue.~   "
142873|NCT01697189|"~     The general aim of the study is to promote safe, economic, and environmental-friendly driving~     among long-haul truck drivers. To do this, the investigators will conduct an on-road study on~     i) the relationship of driver sleepiness and stress with driving behaviour and fuel~     consumption and ii) effectiveness of an educational intervention in mitigating sleepiness at~     the wheel. The educational intervention is designed to be employed by occupational health~     care professionals in the future. This solution clearly facilitates the implementation of the~     intervention into practice if it turns out to be effective.~      The investigators specified research questions are the following:~        -  Do truck driver sleepiness and stress at the wheel reach levels that affect driving~          behaviour, fuel consumption and carbon emissions?~        -  What are the sources of sub-optimal arousal at the wheel in truck drivers?~        -  Can truck driver sleepiness be mitigated by an educational intervention, and if yes,~          does it improve driving behaviour and decrease fuel consumption and carbon emissions as~          well?~   "
142874|NCT01697176|"~     This is an observational study of lone Coronary Artery Bypass Grafting procedures with~     endoscopic vein graft harvesting using best harvesting practices.~   "
142875|NCT01697163|"~     This study is based on the following hypothesis De novo resistance to EGFR-TKI in EGFR~     mutation positive patients is related with mutations in EGFR downstream genes.~      Investigators will prospectively collect genomic DNA and clinical data regarding treatment~     outcomes to EGFR-TKI in NSCLC patients with activating EGFR mutations. Investigators will~     sequence candidate mutations of EGFR downstream genes and analyze c-met gene amplification~     and protein expression in PTEN, HGF, and IGFR. To identify genetic mutations, amplification,~     and protein over expression as predictive markers of treatment outcomes, investigators~     analyzed the association of treatment outcomes with the presence of genetic alteration or~     protein over expression. Investigators will attempt to identify biomarkers that are able to~     predict de novo resistance to EGFR-TKI in EGFR mutated NSCLC.~   "
142876|NCT01697150|"~     Automated closed-loop control (CLC) of blood glucose, known as artificial pancreas (AP) can~     have tremendous impact on the health and lives of people with type 1 diabetes (T1DM). The~     investigators inter-institutional and international research team has been on the forefront~     of CLC developments since the beginning of the JDRF Artificial Pancreas initiative in 2006.~     Thus far, the investigators have conducted three closed-loop control clinical trials~     (totaling 60 subjects with T1DM), which demonstrated significantly more time in an acceptable~     target blood glucose range during CLC, and significantly fewer hypoglycemic events during~     CLC compared to open loop. The investigators overall objective is to sequentially test,~     validate, obtain regulatory approval for, and deploy at home, a closed-loop Control-to-Range~     (CTR) system comprised of two algorithmic components: a Safety Supervision Module (SSM) and a~     Hypoglycemia Mitigation Module (HMM). The SSM will monitor the safety of the subject's~     continuous subcutaneous insulin infusion pump (CSII) to prevent hypoglycemia and will also~     monitor the integrity of continuous glucose monitor (CGM) data for signal sensor deviations~     or loss of sensitivity. The HMM will be responsible for the optimal regulation of~     postprandial hyperglycemic excursions through correction boluses.~      This study will test the ability of AP Platform to (1) run CTR in an outpatient setting, and~     (2) be remotely monitored. Specifically, this study involves studying adults with T1DM who~     are experienced insulin pump users. Subjects will spend two nights (-42 hours) in a local~     hotel, during which the AP Platform will be remotely monitored in an adjacent hotel room for~     validation that remote system monitoring can successfully occur. During the study, study~     subject will be responsible for. operating the CTR system with nursing and technicians~     available~   "
142877|NCT01697137|"~     The number of persons on the national solid organ waiting list continues to increase while~     the number of donated organs has failed to keep pace. In some portions of northeastern Ohio~     the donation rate is as low as 32%. There is a positive association between discussing organ~     donation with a primary care physician and signing a donor card. However, such discussions~     are rare. The investigators propose a blinded randomized controlled trial to evaluate the~     effectiveness of two interventions: 1) showing a donation video to patients in primary care~     settings waiting to see their physician and 2) cueing of primary care providers to have~     donation discussions with their patients. The study will be conducted throughout Cuyahoga~     County in at least 10 ambulatory clinics associated with a single county medical system. Nine~     hundred patients over 15.5 years of age will be enrolled. The investigators hypothesize that~     patients exposed to the interventions will be 1) more likely to consent to donate organs, 2)~     more likely to have donation discussions with their primary care providers, and 3) equally~     satisfied with the time spent with their doctor compared to patients who are not exposed to~     the interventions.~   "
142878|NCT01697124|"~     The Children in Action (CIA) program was a five month physical activity intervention. This~     intervention was a feasibility study with 3- to 5-year-olds enrolled in four Head Start~     centers. After baseline assessment, centers were matched by ethnicity and for number of~     participants and randomly assigned to either the intervention or the control condition. A~     total of 224 preschool children were randomly selected across the four centers. To evaluate~     the efficacy of the CIA intervention, the change in physical activity, gross motor skills and~     weight during the awake time and used mixed effect time-series regression models was~     compared. Observations did not show a statistical difference between intervention and control~     groups in physical activity level during the awake time, gross motor development or weight~     status. It was demonstrated that it is feasible to conduct the SPARK-EC curriculum among~     preschool children attending Head Start Centers but that an increased dose and/or longer~     intervention duration will be required to impact gross motor skills, weight status and~     physical activity levels during this critical early childhood development stage.~   "
142879|NCT01697111|"~     This is a multi-center, randomized, double-blinded, placebo-controlled, parallel-group study~     (24-week treatment-comparison phase) with an open-label reference arm of active comparator~     (dienogest) followed by 28-week long-term treatment phase.~      The primary objective of this study is to confirm the superiority of BAY86-5300 when~     administered with an extended flexible regimen for the treatment of endometriosis-associated~     pelvic pain in comparison to placebo in Japanese endometriosis patients within 24 weeks.~      The secondary objective is to investigate the long-term safety of BAY86-5300 in patients~     treated with an extended flexible regimen for one year, and the bleeding pattern of~     BAY86-5300 when administered with an extended flexible regimen compared to dienogest.~   "
142880|NCT01697098|"~     The investigators sought to determine whether the incidence of neonatal respiratory distress~     syndrome (RDS) in preterm fetuses is similar with 12- vs 24-hour dosing interval of~     dexamethasone.~   "
142881|NCT01697085|"~     Aim of this study is to investigate the effects of intake of sea buckthorn oil on mucous~     membranes~   "
142882|NCT01697072|"~     This is a phase 3, multicenter, randomized, double-blind, placebo controlled study of~     epirubicin, cisplatin & capecitabine (ECX) with rilotumumab or placebo for untreated advanced~     MET-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma~   "
142883|NCT01697059|"~     Several recent studies have examined the feasibility and benefits of nonoperative treatment~     of perforated appendicitis in children. One such study showed a trend toward longer operative~     times for patients randomized to immediate appendectomy, but no overall advantage. In another~     larger study, the costs of delayed appendectomy for perforated appendicitis were higher - in~     part related to readmissions in the interval (6-8 weeks). Nevertheless, these and other~     studies have demonstrated the safety of delaying appendectomy for perforated appendicitis.~      Emergency appendectomy is a well-established approach, and postoperative recovery in children~     is fast. Nevertheless, from the onset of symptoms through the hospital stay and the~     postoperative recovery, appendicitis causes a disruption of a family's normal routine~     (absence from school and work) of up to 1-2 weeks. Because this is an unplanned operation,~     patients have to wait until an operating room becomes available, or elective operations have~     to be placed on hold to accommodate the emergency operation. Each year, more than 250~     children undergo an appendectomy at HCH. This represents 250 episodes of emergency surgery,~     or about one emergency add-on operation per working day. If an initial trial of antibiotics~     is safe for the treatment of appendicitis, converting an emergency operation into an~     elective, scheduled outpatient procedure may reduce stress and disruption of routine for~     patients and their families - and may allow better operating room planning for health care~     professionals and hospitals.~      The investigators hypothesize that initial antibiotic treatment of acute (non-perforated)~     appendicitis, followed by scheduled outpatient appendectomy, reduces the overall cost of~     treating the disease and results in greater patient and family satisfaction.~      This pilot study aims to establish the safety and feasibility of treating acute appendicitis~     with intravenous antibiotics, followed by outpatient oral antibiotics. Patients and their~     families will be offered the possibility of initial nonoperative treatment and subsequent~     outpatient elective appendectomy in a nonrandomized, single arm study.~   "
142884|NCT01697046|"~     This will be a pilot, open label study involving 65 participants. All participants will be~     followed until seroconversion or until the last enrolled participant completes one year of~     follow-up, whichever happens first. Participant study number will be given at the screening~     visit, prior to inclusion in the study.~      The chosen intervention and study regimen are based on the dynamics of viral infection and~     the pharmacokinetics of the study drugs. In order to inhibit reverse transcription nucleoside~     and nucleotide analogues need to be phosphorylated intracellularly. On the other hand,~     available data indicate that it takes approximately 10 hours between exposure and HIV viral~     integration, offering a window of opportunity for Raltegravir to block integration and thus~     prevent infection, given that this drug does not need to be metabolized to exert its effect.~     The intervention will be maintained for 4 weeks following exposure, in accordance with~     Brazilian and CDC guidelines for PEP.~   "
142885|NCT01697020|"~     The primary objective of this study is to determine whether the test product, mercaptopurine~     oral 100 mg/5 mL suspension, and the reference product, Purinethol® 50 mg tablets are~     bioequivalent. For this purpose the PK profile of 6-mercaptopurine (6-MP) will be compared~     after administration of a single dose of each of the two formulations, under fasting~     conditions. The secondary objective is to assess the safety and tolerability of the test~     product, mercaptopurine oral 100 mg/5 mL suspension.~   "
142886|NCT01697007|"~     Electroporation will increase the efficiency of DNA priming in terms of immune responses and~     will lead to a dose sparing DNA vaccine regimen. Furthermore increased DNA vaccine~     concentration will reduce the number of shots necessary to deliver the full dose and induce~     comparable immune responses as with lower DNA vaccine concentrations.~   "
142887|NCT01696994|"~     This clinical trial studies whether screening methods used to diagnose cancer of the~     prostate, lung, colon, rectum, or ovaries can reduce deaths from these cancers. Screening~     tests may help doctors find cancer cells early and plan better treatment for ovarian cancer.~     The ovarian cancer screening tests are part of a trial that addresses the screening of four~     cancer sites, each with their own results record: prostate (NCT00002540), lung (NCT01696968),~     colorectal (NCT01696981), and ovarian (NCT01696994).~   "
142888|NCT01696981|"~     This clinical trial studies whether screening methods used to diagnose cancer of the~     prostate, lung, colon, rectum, or ovaries can reduce deaths from these cancers. Screening~     tests may help doctors find cancer cells early and plan better treatment for colorectal~     cancer.~   "
142889|NCT01696968|"~     This clinical trial studies whether screening methods used to diagnose cancer of the~     prostate, lung, colon, rectum, or ovaries can reduce deaths from these cancers. Screening~     tests may help doctors find cancer cells early and plan better treatment for lung cancer.~   "
142890|NCT01696955|"~     This randomized phase II trial studies how well cetuximab with or without tivantinib works in~     treating patients with head and neck cancer that has come back (recurrent), has spread to~     other places in the body (metastatic), or cannot be removed by surgery. Monoclonal~     antibodies, such as cetuximab, may interfere with the ability of tumor cells to grow and~     spread. Tivantinib may stop the growth of tumor cells by blocking some of the enzymes needed~     for cell growth. It is not yet known whether cetuximab is more effective with or without~     tivantinib in treating patients with head and neck cancer.~   "
142891|NCT01696942|"~     Hypothesis: Cimzia provides superior reduction in endoscopic and clinical recurrence rates~     compared to mesalamine in the treatment of Crohn's disease one-year following ileocolectomy~     for Crohn's disease.~        1. To evaluate the difference in clinical recurrence rates between certolizumab and~          mesalamine after 4 weeks, 3 months, 6 months, 9 months, and 12 months of use following~          ileocolectomy for Crohn's disease using the Crohn's Disease Activity Index (CDAI).~        2. To compare the endoscopic recurrence rates at one year following surgery between~          patients treated with certolizumab and mesalamine.~        3. To compare medication side-effects and tolerance of therapy, including the need to~          interrupt therapy due to side-effects, the incidence of opportunistic infections, and a~          general assessment of each patient's health and well-being using the short-form 36~          (SF-36).~   "
142892|NCT01696929|"~     This study is a Phase 1 clinical trail to determine the safety, tolerability, and efficacy of~     Tocilizumab (Actemra) as an adjunct to antipsychotic medications in stable outpatients with~     schizophrenia. Tocilizumab (structural formula C6428H9976N1720O2018S42) is a recombinant~     humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin~     (Ig) gamma-1 subclass. Tocilizumab is formulated as a concentrate for solution for infusion,~     and will be administered by intravenous infusion.~      The investigators propose an 8-week trial to determine the safety, tolerability, and~     effectiveness of tocilizumab, given in addition to antipsychotic medications, in 10 stable~     outpatients with schizophrenia. The investigators hypothesize that tocilizumab will be~     associated with clinically significant improvement in cognition and total psychotic symptoms~     over the course of the trial. Tocilizumab is administered as an intravenous infusion every 4~     weeks. Following a screening evaluation, participants will receive two infusions of~     tocilizumab, one at baseline and another at week 4 of the study. The investigators will~     measure changes in cognitive function and symptoms over an 8-week period. Complementing~     previous positive clinical trials of non-steroidal anti-inflammatory drugs, this would be a~     proof-of-concept study that targeting specific cytokines is a viable treatment for~     schizophrenia.~      Interleukin 6 and its receptor were discovered and cloned at Osaka University, Japan, by~     Tadamitsu Kishimoto in the 1980s. In 1997, Chugai Pharmaceuticals began the clinical~     development of tocilizumab for the treatment of rheumatoid arthritis. Clinical studies for~     Castleman's disease and systemic juvenile idiopathic arthritis started in 2001 and 2002,~     respectively. Hoffmann-La Roche co-developed the drug due to a license agreement in 2003.~      Data presented in 2008 showed the effectiveness of tocilizumab in combination therapy with~     methotrexate for rheumatoid arthritis treatment. In further studies, it was effective and~     generally well tolerated when administered either as monotherapy or in combination with~     conventional disease-modifying antirheumatic drugs in adult patients with moderate to severe~     rheumatoid arthritis.~   "
142893|NCT01696916|"~     The aim of this study is to investigate the development of partial pressure of carbon dioxide~     during the 6-min walking test and during night in Chronic Obstructive Pulmonary Disease~     (COPD)-patients (GOLD stage IV). Therefore the partial pressure of carbon dioxide, oxygen~     saturation and the heart rate are registered by a device called Sentec during the mentioned~     periods. In addition a measurement of activity is realised by an activity monitor~     (Sensewear).~   "
142894|NCT01696903|"~     Pancreaticoduodenectomy is a surgical procedure for removing cancer in the pancreas, the bile~     system or the duodenum that is associated with a high rate of complications. The study wants~     to investigate whether a new technique to reconstruct the joint between the pancreatic gland~     and the short bowel can reduce the rate of severe complications after this complex surgical~     procedure.~   "
142895|NCT01696890|"~     The aim of this study is to evaluate this model of telemonitoring-assisted close supervision~     and interaction between first and second line health professionals versus a model of~     telemonitoring without this integrated approach.~   "
142896|NCT01696877|"~     This research is being done to see if an investigational prostate cancer vaccine, called~     GVAX, can safely be given together with a single intravenous injection of a drug called~     cyclophosphamide to men that will undergo surgery to remove their cancerous prostate glands~     who have also received standard hormonal therapy.~   "
142897|NCT01696864|"~     The objective of this study is to examine monitored rehabilitation therapy over the internet~     to improve upper limb function for stroke patients. Home rehabilitation for stroke patients~     will avoid the burden of arrival to the health facilities, making it easier on them and~     improve their quality of life and the lives of their caregivers. To achieve this goal the~     investigators will examine the effectiveness and feasibility of home rehabilitation system of~     upper limb, consisting of ergonomic accessories (hand and arm tutors).~      The quantitative indices will be based on the quantitative clinical measures that are used in~     regular evaluations of stroke patients and function and range of motion indices as received~     from the system.~   "
142910|NCT01696695|"~     This observational study will evaluate the efficacy and safety of different capecitabine~     based chemotherapies, alone or in combination with other therapies, as first line treatment~     of metastatic colorectal cancer in participants during everyday clinical practice.~   "
142911|NCT01696682|"~     The study hypothesized that a narrow gastric conduit(less than 3cm in width) would minimize~     anastomotic leakage following minimally invasive esophagectomy. Therefore we raise this~     random-controlled research, and investigate the leakage ratio from different widths of~     gastric conduit formed during the operation.~   "
142898|NCT01696851|"~     People with Spinal cord injury with tetraplegia suffer from respiratory problem due to~     weakness of the muscles and because the autonomic system dysfunction.~      Exercise is one way of preserving and improving physical fitness and directly and indirectly~     reduce risk factors such as insulin resistance, weight loss and low values of HDL. subjects~     with spinal cord injury with tetraplegia have limited options for exercise: table tennis,~     gym, pool and more. Because of the nature of the injury which includes the sympathetic~     failure, they can not easily get the desired pulse to improve physical fitness.~      Wheelchair rugby in Canada was developed specifically for people with tetraplegia who could~     not participate in wheelchair basketball. The game combines short, quick races with different~     aerobic capabilities. Previous studies have shown that participants in wheelchair rugby~     Improve anaerobic power, oxygen consumption, physical fitness and daily functioning.~     Wheelchair rugby improves self-confidence and as a result it affects other areas of life.~     Another study examined sense of self-efficacy, saw improvement in this index for rugby~     players in a wheelchair at high levels.~      In the present study the investigators aim to examine whether regular participation in~     wheelchair Rugby for a season has more impact than other routine exercise (table tennis, gym,~     swimming).~   "
142899|NCT01696838|"~     The purpose of this study is to determine whether acupuncture or moxibustion therapies are~     effective in the treatment of Crohn's disease. Meanwhile, the investigators aim to evaluate~     the efficacy by functional magnetic resonance imaging.~   "
142900|NCT01696825|"~     The purpose of this study is to determine which of three delivery systems of vaginal diazepam~     have the best systemic absorption, measured by serum diazepam levels. The three delivery~     systems are: moistened tablet, suppository or cream. Additionally the study will compare the~     side effects and absorption of vaginal diazepam with oral diazepam. Vaginal diazepam is used~     off-label vaginally to relax pelvic floor muscles and reduce pelvic pain caused from pelvic~     floor dysfunction.~   "
142901|NCT01696812|"~     The objectives of this study are (1) to compare the clinical outcome in correlation with the~     electrode positions estimated by web-based image fusion of the preoperative MRI and the~     postoperative brain CT taken at a stable period after surgery using mutual information~     technique in the patients with advanced Parkinson's disease (PD) after bilateral STN DBS and~     (2) to examine whether the documentation of the electrode position by using mutual~     information technique at a stable period after unilateral or bilateral STN stimulation~     provides useful information for the postoperative programming.~   "
142902|NCT01696799|"~     To compare the pharmacokinetics of Econazole Nitrate Foam with Econazole Nitrate Cream in~     subjects with interdigital tinea pedis aged 12 years to less than 18 years.~   "
142903|NCT01696786|"~     The specific aim of this study is to further develop methods of oocyte cryopreservation and~     evaluate their impact on reproductive outcomes.~   "
142904|NCT01696773|"~     Eating a diet rich in tomatoes has been associated with decreased risk for a variety of~     diseases. Tomatoes contain red-colored lycopene (one type of pigment in the class of pigments~     called carotenoids), which has been associated with the decreased risk of disease in those~     consuming tomato products; however, tomatoes also contain flavonoids, which may also have~     health promoting effects. The Tangerine tomato, a unique tomato variety, contains lycopene in~     a different form that in red tomatoes and this contributes to their characteristic orange~     color. This orange lycopene is more similar to the most common form of lycopene found in~     the blood and tissue of people who eat a tomato-rich diet, and may be more easily absorbed by~     the body.~      The objectives of this study are to determine if carotenoids and flavonoids from Tangerine~     tomatoes are more easily absorbed by the body than red tomatoes, and to examine if eating~     Tangerine versus red tomatoes impacts markers of inflammation (response to harmful substances~     by the body).~   "
142905|NCT01696760|"~     This is a research study to compare the efficacy of aspirin (acetylsalicylic acid) and~     pneumatic compression devices versus enoxaparin (also known as Lovenox) and pneumatic~     compression devices in preventing deep vein thrombosis in patients with pelvic and lower~     extremity malignant tumors and undergoing surgery. Pneumatic compression devices are also~     known as sequential compression devices and are inflatable compression sleeves that are~     placed around patient's legs to reduce the risk of clot formation deep vein thrombosis.~     Pneumatic compression devices are made of a soft material that wraps around the lower leg and~     periodically squeeze the calf. A deep vein thrombosis is a blood clot. Most hospitalized~     patients wear these as a preventive measure. Pneumatic compression devices alone are not~     sufficient to prevent deep vein thrombosis formation. Therefore, medicines, such as aspirin~     and enoxaparin are utilized. Both drugs are used for prevention, but there are no studies in~     patients with musculoskeletal tumors which have determined whether one drug is better than~     another. The knowledge gained from this study will determine whether aspirin and pneumatic~     compression devices is the same or better than enoxaparin and pneumatic compression devices~     in preventing deep vein thrombosis in this patient population and may result in fewer wound~     and bleeding complications~   "
142906|NCT01696747|"~     To expand a registry of patients for the study of the epidemiology, etiology, and degree of~     morbidity associated with gastroparesis.~   "
142907|NCT01696734|"~     The goal of this clinical research study is to learn if domperidone can help to control~     chronic GI disorders. The safety of this drug will also be studied.~      Domperidone is designed to stimulate contraction of the stomach to increase its ability to~     empty itself of the food.~      This is an investigational study. Domperidone is not FDA approved or commercially available.~     It is currently being used for research purposes only.~      Up to 200 patients will be enrolled in this study. All will take part at MD Anderson.~   "
142908|NCT01696721|"~     In previous studies, Proton Beam Radiation Therapy (PBRT) has been found to show better~     results in treating patients with cancer, both because there is better control of where in~     the body the radiation is directed and because it is associated with less severe long term~     side effects. However, there is limited published data demonstrating these results. The goal~     of the Pediatric Proton Consortium Registry (PPCR) is to enroll children treated with proton~     radiation in the United States in order to describe the population that currently receives~     protons and better evaluate its benefits over other therapies. The data collected from this~     study will help facilitate research on proton beam radiation therapy and allow for~     collaborative research. The PPCR will collect demographic and clinical data that many centers~     that deliver proton radiation therapy already collect in routine operations.~   "
142912|NCT01696669|"~     Tumors of the Ewing sarcoma family (ES) affect children, adolescents and young adults. The~     reported incidence is 0.6 cases per million inhabitants every year. The peak incidence occurs~     between 10 and 20 years and it is rarely diagnosed beyond 30. The ES is a severe disease with~     a progression-free survival after 5 years of 60% in cases without metastasis and deadly in~     the majority of patients presenting metastasis. The ES is considered a systemic disease~     because, despite receiving an adequate local treatment, over 90% of patients deaths occur due~     to disseminated disease. Combined therapy of surgery, radiotherapy and chemotherapy has led~     to an improvement in the prognosis, achieving a survival of about 60% in most series~      The MSKCC P6 protocol was developed for the treatment of high risk ES. In 2003, Kolb et al.~     reported the MSKCC experience after a 4-years follow-up of 68 patients who had been included~     from 1990 to 2001. Following the MSKCC P6 protocol, a survival rate of 82% was achieved in~     patients without metastasis, superior to the achieved with less intensive protocols.~     Following the guidelines of the MSKCC P6 protocol, in 2002 we modified the treatment schedule~     to create the modified P6 protocol (MP6). GEIS intends to develop MP6 as a clinical trial,~     which could provide the following potential advantages about current treatments:~        1. Lower total dose of alkylating agents.~        2. Early cardioprotection with dexrazoxane.~        3. Radiotherapy adjusted to the initial response.~        4. Pilot trial with the combination of Gemcitabine + Docetaxel for high-risk patients.~   "
142913|NCT01696656|"~     Intestinal insufficiency due to short bowel syndrome is a chronic, disabling condition with~     significant morbidity and mortality.Standard care includes home parenteral/enteral nutrition~     as well as intestinal transplantation, however multiple drugs, vitamins, antibiotics and~     symptom-relieving agents may be required. Prescriptional pattern of these drugs will be~     analyzed in a clinical cohort.~   "
142914|NCT01696643|"~     The purpose of this study is to evaluate the long-term safety and tolerability of CB-5945 for~     the treatment of opioid-induced constipation (OIC) in adults taking opioid therapy for~     chronic non-cancer pain.~   "
142915|NCT01696630|"~     This is a monocentric study in 2 steps: A safety part to assess the feasibility of using~     Xenon in association with a thoracic epidural analgesia (TEA) with a sequential recruitment~     of 3, 6 or 9 patients according to predefined safety rules. The second part will randomly~     allocated patients (1:1) to receive TEA+Xenon or TEA+Desflurane. 28 patients will be enrolled~     and followed over 45 days.~   "
142916|NCT01696617|"~     The investigators hypothesized that combined pharmacotherapy using adjunctive aripiprazole of~     standard antidepressants would be associated with improved depression response in Major~     depressive disorder, especially in Quality of life.~      The investigators compare the mean changes in the quality of life between before add-on and 8~     weeks treatment of aripiprazole and between before add-on and 6 weeks treatment of~     aripiprazole.~   "
142917|NCT01696604|"~     This study is the first administration of GSK2849466 in humans. This will be a single centre,~     randomized, double-blind, placebo-controlled study, to investigate the safety, tolerability,~     pharmacokinetics (PK), and pharmacodynamics (PD) of GSK2849466, given as single and repeat~     oral doses up to 14 days to healthy male subjects. Part A will be a randomized placebo~     controlled and 4-way crossover study. It will include two cohorts of 8 subjects each. In each~     cohort there will be 4 study periods each approximately of 1 week including 6 days of~     washout. Each subject will receive a total of 3 active doses as ascending single oral dose of~     GSK2849466 and 1 placebo dose during the course of their participation in the study. The~     first (bridging dose) dose provided to subjects in Cohort 2 will be the same as the last~     dose provided to subjects in Cohort 1. The single doses of GSK2849466 planned in Part A of~     this study are: 0.01, 0.03, 0.1, and 0.3 milligram (mg) in Cohort 1 and 0.3, 1, 3, and 10 mg~     in Cohort 2. In cohorts 1 and 2 all available safety, tolerability, and PK data will be~     reviewed prior to each dose escalation. The dosing schedule in Part A may be adjusted to~     expand a cohort or to add an additional cohort(s) in order to further evaluate additional~     doses or repeat evaluation of a dose level already studied. Part B will be a randomized~     placebo controlled, parallel group study. It will include three cohorts of 12 subjects each.~     Each subject will receive repeat doses of GSK2849466 over 14 days. The doses chosen for Part~     B will be based on the safety, tolerability, and PK data from Part A. Subjects in Cohort 4~     (and/or an another cohort [s] as determined based on Part A PK data) will be dosed in the~     fasted state on Days 1 and 14 and in the fed state on Day 7 when subjects will receive a~     standard meal 30 minutes prior to dosing. Part B will provide sufficient safety and~     tolerability data to bridge to longer duration studies. The study duration, including~     screening and follow-up, is not expected to exceed 70 days for subjects in the study.~   "
142918|NCT01696591|"~     The purpose of the study is to determine the long-term safety and exploratory efficacy of~     NEUROSTEM®-AD, administered via an open brain surgery to subjects with dementia of the~     Alzheimer's type, who were eligible for and enrolled in the earlier part of the phase I.~     Aside from the subjects who completed the earlier part of the Phase I, 3 additional subjects~     with comparable demographics and disease characteristics as the treatment group will be~     enrolled into a control group, followed-up for 3 months, and compared for various disease~     progression indicators with the treatment group.~      The hypothesis is that NEUROSTEM®-AD is safe and effective in the treatment of dementia of~     the Alzheimer's type.~   "
142919|NCT01696578|"~     This study will measure the effects of biofeedback supported cognitive behavioral therapy~     (BF-CBT) and group physiotherapy intervention in victims of torture and massive violence in~     Kosovo. The investigators aim to restore physical and psychosocial functioning of the victims~     of torture and massive violence with available rehabilitation practice and integrate them~     into the community. It is also our objective to build local knowledge and expertise to apply~     measurement principles and CBT methods in the Balkan region.~   "
142920|NCT01696565|"~     The objectives of this Phase I/II study are:~        1. To find out the maximum tolerated dose (MTD) of PG2 in patients with advanced malignancy~          receiving chemotherapy and to define a Study Dose for Phase II.~        2. To evaluate the hematopoietic and immunological responses after administering of PG2.~          Primarily to study the biological response of PG2, defined as WBC count in this study,~          and secondarily to study the immunological factors, IL-2, IL-6, TGF-beta, and G-CSF.~   "
142921|NCT01696552|"~     A Prospective, randomized, clinical controlled study comparing conventional knee arthroplasty~     and the Patient-specific positioning guides (PSPG) (Signature Patient Care, Materialise)~     using the Vanguard Total Knee System (Biomet)~   "
142922|NCT01696539|"~     The purpose of this study is to determine whether sustainable daily physical activity is~     effective in improving biological indicators of health and self-reported quality of life in~     men with prostate cancer.~   "
142923|NCT01696526|"~     The aim of this study is to investigate the bioavailability of conventional and vitamin D~     fortified fish as measured by the increase of the specific hydroxy form by 25(OH)D3.~   "
142924|NCT01696513|"~     The primary objective of this study is to determine whether the use of standard treatment in~     conjunction with suction will improve acne scars compared to a standard treatment alone.~   "
142925|NCT01696500|"~     Patients diagnosed with Stevens-Johnson syndrome and Toxic Epidermal Necrolysis were~     confirmed based on the investigators national diagnostic criteria. Patients who meet all~     inclusion criteria and do not conflict with the exclusion criteria will receive NPB-01~     (intravenous immunoglobulin) 400mg/kg/day for five consecutive days. Subsequently, efficacy~     of NPB-01 for therapy of Stevens-Johnson syndrome and Toxic Epidermal Necrolysis will be~     evaluated the disease evaluation score et al.~      As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse~     events by 20 days after the start of the study treatment.~   "
142926|NCT01696487|"~     The spectrum of NAFLD as emerging epidemic ranges from steatosis to steatohepatitis (NASH),~     cirrhosis and hepatocellular carcinoma (HCC). Disease progression is poorly understood and~     treatment options are limited. Fructose overconsumption has been associated with gut~     permeability and progression of NAFLD. To unravel the mechanisms of fructose-induced~     intestinal changes, volunteers will receive a 4-week fructose challenge prior to assessment~     of intestinal permeability/translocation using endomicroscopy, sugar probes, serum markers of~     intestinal damage, inflammation, iron/copper homeostasis and histological/molecular analysis~     of intestinal biopsies. Findings in volunteers will be compared with liver patients~     undergoing study procedures without fructose challenge. Translational in vitro experiments~     will explore cellular responses to fructose and endotoxin. This project should provide novel~     insights into dietary induced alterations of the gut integrity in progression of NAFLD to~     NASH.~   "
142927|NCT01696474|"~     This multicenter, phase II, open label study will enroll patients with chronic cold~     agglutinin disorder. A single course of Bortezomib will be given at the dose of 1,3 mg/sqm iv~     on days 1, 4, 8, 11.~   "
142928|NCT01696461|"~     This is a Phase II, open-label, two strata, multicenter, prospective study of~     plerixafor-mobilized HLA-identical sibling allografts in recipients with hematological~     malignancies. This study will establish the safety and efficacy of subcutaneous plerixafor~     for this purpose.~   "
142929|NCT01696448|"~     Though medical treatment has been effective in the treatment of cardiometabolic diseases~     (including coronary atherosclerosis and diabetes mellitus), the incidence of these disorders~     continues to be high. Many reasons are responsible, but lifestyle changes, including an~     increased prevalence of obesity and the metabolic syndrome, are significant for this cause.~     Diagnosis and treatment of obese patients with hypertension requires that health care~     providers address the issues of hypertension, glucose intolerance, body weight and~     dyslipidemia. A sedentary lifestyle and poor cardiorespiratory fitness are not only~     associated with the (cardio) metabolic syndrome but could actually be considered features of~     the metabolic syndrome. These issues are significant in the health of certain individuals,~     who experience greater difficulty in treated BP control, experience increased hypertensive~     and diabetic complications, and have higher levels of obesity.~      In this study, the investigators will evaluate the efficacy of the nutritional supplements~     berberine, alpha-lipoic acid, and picrorhiza (CAR-191) when consumed 30 minutes before meals,~     on appetite suppression, body composition and weight control. Additionally, the investigators~     will evaluate the effects of this combination of nutraceuticals on the mechanistic effects of~     oxidation, inflammation, and vascular function in a high-risk population with the metabolic~     syndrome.~      Primary Objective To assess the comparative effect of a combination (known as CAR-191) of~     berberine (200 mg), alpha-lipoic acid (150 mg), and picrorhiza (100 mg) three times a day,~     compared to placebo three times a day, on parameters relate to appetite suppression, weight~     control and body composition in a high risk population with the metabolic syndrome.~      Secondary Co-objectives~      To evaluate the effects of CAR-191 versus placebo on changes in:~        -  Endothelial function using noninvasive brachial artery reactivity (BAR) ultrasound~        -  Biomarkers including IL-6, HOMA-IR, HbA1C, hsCRP, adiponectin, plasma/urine~          isoprostanes, PAI-1, TNFα-II, aldosterone, and glutathione redox ratio~        -  Urinary protein excretion~        -  Clinical chemistry including plasma glucose, blood urea nitrogen, creatinine, total~          bilirubin, uric acid, transaminases (SGOT/AST, SGPT/ALT), alkaline phosphatase,~          C-reactive protein, and lipoproteins~   "
142930|NCT01696435|"~     The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial~     in 25,875 U.S. men and women investigating whether taking daily dietary supplements of~     vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of~     developing cancer, heart disease, and stroke in people who do not have a prior history of~     these illnesses. This ancillary study is being conducted among participants in VITAL and will~     examine whether vitamin D or fish oil: 1) reduces risk of clinical depressive syndrome, 2)~     yields better mood scores over time, compared to placebo.~   "
142931|NCT01696422|"~     This is a phase II step-wise, randomized, multicenter, double-blind and controlled clinical~     trial to evaluate the safety and immunogenicity of a attenuated tetravalent lyophilized~     dengue vaccine manufactured by Butantan Institute. Three Clinical Sites at University of Sao~     Paulo - Brazil will participate in the study. A total of 300 volunteers will be recruited and~     divided into two steps: Step A (with no previous exposure to dengue) and Step B (with and~     without previous exposure to dengue). In step A the participants will be assigned to receive~     either the lyophilized vaccine, or the liquid vaccine(developed at NIH and produced and~     formulated at Butantan according to the NIH-Protocol), or the placebo. In Step B participants~     will be assigned to receive either the lyophilized vaccine, or the placebo. Both vaccine~     formulations (lyophilized and liquid) are composed of the same attenuated viruses: rDEN1∆30,~     rDEN2/4∆30(ME), rDEN3∆30/31, and rDEN4∆30. At the end of the study, 20 volunteers will have~     received the liquid formulation (NIH), 210 the lyophilized formulation (Butantan), and 70~     will have received the placebo. All participants included in both steps will be followed by a~     period of five years after their inclusion in the study. The study hypothesis is that the~     investigational lyophilized dengue vaccine manufactured by Butantan Institute is safe and~     confers balanced immune response, after one dose of 1000PFU, to all for vaccine viruses.~   "
142932|NCT01696409|"~     Vitamin D deficiency is now recognized as one of the most common vitamin deficiencies in~     adults in the United States. Vitamin D deficiency has been connected to many chronic health~     diseases. The goal of this innovative research is to identify how vitamin D is able to have~     such wide ranging health benefits. This study will determine which genes are turned on and~     turned off in adults who receive 2000 IU vitamin D3 per day compared to 400 IU vitamin D3 per~     day. Results should provide important new insights about the health benefits of vitamin D for~     adults.~   "
142961|NCT01696032|"~     A 2-part, Phase 2 controlled, open-label, randomized study in patients with~     platinum-resistant recurrent ovarian cancer. In Part 1, patients will receive SGI-110 and~     carboplatin. The optimum dose will be identified in Part 1 based on safety and efficacy. In~     Part 2, patients will be randomized to receive the dose identified in Part 1 plus carboplatin~     or one of three treatment of choice at the discretion of the investigator. The treatment of~     choice consists of topotecan, pegylated liposomal doxorubicin, or paclitaxel.~   "
142933|NCT01696396|"~     This is a randomized, double-blind, placebo-controlled, parallel group, multiple dose study~     to evaluate the efficacy of AMG 181 compared with placebo as measured by the proportion of~     subjects in remission (CDAI score < 150) at week 8 (primary endpoint). After completing all~     screening assessments and meeting all eligibility criteria, subjects will be randomized to~     receive placebo or AMG 181 at various doses per protocol. A maximum of approximately 80% of~     subjects with any prior anti-TNF agent use will be allowed in the study. At the end of the~     double blind period, subjects will enter an open-label period during which all subjects will~     receive open-label AMG 181 at a single dose level according to protocol. Subjects who fail to~     achieve minimal improvement, or experience disease worsening after initial response are~     eligible to enter the open-label period early beginning at week 12 or after. Subjects that~     complete the open-label period or early terminate from the study will enter the 2 year safety~     follow up period.~   "
142934|NCT01696383|"~     The purpose of this study is to evaluate the efficacy of changing to DuoTrav® (Travoprost~     0.004%/Timolol 0.5%) from prior prostaglandin analogue or beta-blocker monotherapy in Russian~     glaucoma patients with open-angle glaucoma or ocular hypertension whose intraocular pressure~     (IOP) is uncontrolled while on their current treatment.~   "
142935|NCT01696370|"~     Hypertrophic cardiomyopathy (HCM) is a common inherited heart condition that causes~     breathlessness, chest pain and fatigue. There are few treatments available. The investigators~     have recently shown that a drug called perhexiline reduced symptoms and improved exercise~     capacity in patients with HCM. This change appears to be driven by alterations in myocardial~     energy metabolism. The aim of this trial is to test a similar drug, trimetazidine, in a group~     of symptomatic patients with non-obstructive HCM.~      HYPOTHESIS: trimetazidine will improve symptoms, peak oxygen consumption, cardiac function~     and arrhythmia burden in medically refractory symptomatic patients with non-obstructive HCM.~   "
142936|NCT01696357|"~     This study will examine an innovative strategy to monitor asthma symptoms by using existing~     technology to develop a non-invasive device for monitoring asthma symptoms in adolescents.~     Using an iPod as a platform, and current sound data analysis techniques, a prototype device~     will be developed that will directly monitor the chosen parameters of asthma symptoms,~     including wheezing, coughing and activity levels. This small non-invasive device will be~     continuously carried by or placed in close proximity to the adolescent on a daily basis. It~     is hypothesized that such a device would be acceptable to adolescents and would lend accuracy~     and objectivity to symptom assessment; something that existing monitoring strategies have yet~     to achieve. It will also stimulate the adolescents' partnership in asthma self-monitoring and~     ultimately lead to effective asthma management.~   "
142937|NCT01696344|"~     This prospective study aims to investigate if termination of atrial fibrillation (AF) after~     pulmonary vein antrum isolation (PVAI) without additional ablation of non-PV triggers, in~     long-standing persistent (LSP) AF, is enough to ensure long-term success.~   "
142938|NCT01696331|"~     Text message reminders will improve adherence to lab tests in adolescent liver transplant~     recipients.~   "
142939|NCT01696318|"~     Develop and evaluate a model of organization and management in the management of patients~     with cardiovascular risk factors (hypertension, diabetes mellitus, smoking, obesity, physical~     inactivity, dyslipidemia and family history) in primary care aimed at the compliance, control~     and treatment effectiveness.~   "
142940|NCT01696305|"~     This study is a randomized, double-blind, active controlled phase 3 trial in the patients~     with thyroid disease, who will undergo total thyroidectomy (excluding the patients with the~     patient with the past history of thyroid surgery).~      An eligible patient will be randomized and allocated to either the test group (Hyalobarrier)~     or active-comparator group (Guardix-SG). He/she will undergo marshmallow esophagography in~     detecting esophageal dysmotility at 6 weeks after study intervention and will be followed for~     12weeks.~      During the study, both the patients and the observer for the primary and secondary efficacy~     evaluation will be masked.~      Non-inferiority of the test device (Hyalobarrier) compared to the reference device~     (Guardix-SG) will be confirmed using the primary efficacy outcome,the percentage of normal~     esophageal transit.~   "
142941|NCT01696292|"~     This study aims to shed light on the theoretical concept of mental flexibility and its~     manifestation in adolescents following frontal lobe damage, and to develop a test battery for~     young Hebrew speakers.~   "
142942|NCT01696279|"~     To provide information about the safety and efficacy of lanthanum carbonate in children~     compared to standard treatment.~   "
142943|NCT01696266|"~     This study is conducted in Europe. The aim of the study is to gather information about~     hypoglycaemia (low blood glucose) among patients with Type 1 or Type 2 diabetes mellitus. The~     study is both retrospective and prospective.~   "
142944|NCT01696253|"~     Over the past 30 years much has been learned about the molecular genetics and natural history~     of familial forms of hematuria. However, enhanced understanding of these conditions has yet~     to generate effective therapies for Alport syndrome(AS), the form of familial hematuria~     associated with end-stage renal disease. Males with AS inevitably develop end-stage kidney~     failure, with a 50% likelihood of dialysis or kidney transplantation by age 25 years. There~     is no proven treatment for AS, although studies in animals have suggested several promising~     potential therapies. Pharmacological or biological treatments that might delay or prevent the~     development of kidney failure exist, but need to be evaluated through clinical trials.~     Researchers interested in implementing clinical trials in AS will face several challenges,~     the foremost of which is the relative rarity of the disease, necessitating aggressive efforts~     to identify and recruit potential subjects for multi-center collaborative clinical trials.~     The Alport Syndrome Research Collaborative (ARC) was established in 2009 as a partnership of~     the Alport Syndrome Treatments and Outcomes Registry (ASTOR), the European Alport Registry~     and centers of AS research in Canada, China and France with the objective of testing~     potential treatments to delay or prevent terminal renal failure in people with AS. In this~     feasibility study the five ARC centers will interrogate existing AS registries and databases,~     and monitor accrual of new AS cases over an 18-month period, in order to quantify subjects in~     the disease categories of interest. As part of this project we will examine the utility of~     urinary uromodulin excretion as a marker of kidney injury and potential trial endpoint in AS~     clinical trials. Our goals are to (1) demonstrate that participating centers have access to~     sufficient numbers of males and females with AS to populate adequately-powered clinical~     trials focused on two clinical targets, microalbuminuria and overt proteinuria, and (2) to~     test the hypothesis that in males with AS urinary uromodulin excretion decreases as~     albuminuria and proteinuria increase and that uromodulin offers an independent and insightful~     measure of renal fibrosis and response to therapy.~   "
142945|NCT01696240|"~     The investigators hypothesized that udenafil, a newly developed phosphodiesterase type 5~     inhibitor, would improve symptom, exercise capacity and hemodynamic status in patients with~     mild pulmonary hypertension.~   "
142946|NCT01696227|"~     Background:~      Urinary tract infections (UTIs) are a common and costly cause of doctor visits for children.~     Frequent UTIs trigger kidney damage that leads to serious diseases like high blood pressure,~     pregnancy complications, and kidney failure. Treating UTIs with preventative antibiotics has~     not shown improvement of the risk of these diseases, and contributes to the growing public~     health issue of antibiotic resistant bacteria. Bacteria that cause UTIs originate from the~     bowel. In an effort to reduce the number of UTIs, investigators want to exchange the bacteria~     living in our bowels for a more harmless variety.~      Hypothesis and specific aims:~      Investigators hypothesize a probiotic comprised of a probiotic bacteria will change the bowel~     bacteria, thereby reducing the numbers of infection-causing bacteria, thus reducing frequency~     of UTIs in healthy patients with recurrent UTIs and those patients with urinary tract~     problems that require use of catheters to empty their bladders.~      Aim 1: Investigators plan to challenge infection-causing bacteria like Pseudomonas species,~     Enterococcus species, and Klebsiella species to live in the same environment with the~     probiotic bacteria to see how the numbers of each bacteria change.~      Aim 2: Investigators will culture bacteria that live on urinary catheters and then challenge~     them to live in the same environment as the probiotic bacteria.~      Potential Impact:~      This novel treatment prevents UTIs by exchanging a patient's bowel bacteria for a harmless~     bacteria and reduces the use of antibiotics overall in the community.~   "
142947|NCT01696214|"~     The primary aim of the pilot (SAPS) protocol is to determine the feasibility and utility of~     implementing the provisional design of the full scale TOM trial (e.g., the six month~     treatment period, the impact of the smoking cessation intervention).~      There is no active hypothesis for the Vanguard Protocol.~   "
142948|NCT01696201|"~     Due to physical and physiological changes that occur in pregnant women, depression is very~     common during this period. Recent research findings indicate that antenatal maternal mood~     state impacts on babies health. Nowadays, many researchers are focussed on examining the~     effects of physical exercise on foetal and maternal outcomes.~      The main aim of this study was to assess the effectiveness of a supervised exercise program~     consisted of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises~     (strength and balance exercises), and 10 minutes of pelvis floor muscles training, on the~     prevention and treatment of depression in pregnant women. Additionally, the other purpose of~     the study was to analyze the effects of depression and physical exercise on outcomes.~      Hypothesis: Pregnant women who do regular exercise during their pregnancies would have a~     better mood state than pregnant women who are sedentary, without having any negative effect~     on outcomes.~   "
142949|NCT01696188|"~     This is a randomized, double-blinded, prospective study designed to compare two approaches~     (in the plane of the ultrasound beam and out of the plane of the ultrasound beam) to placing~     an interscalene nerve block and catheter for pain control after open shoulder surgery. Both~     approaches have been used successfully but neither has been proven to be superior. Our~     endpoints are pain scores, time for block placement, and catheter dislodgements. We~     hypothesized that patients with the out-of-plane approach would have decreased pain and fewer~     catheter dislodgements.~   "
142950|NCT01696175|"~     Observational multicentre cohort study. Children admitted to a Dutch PICU are studied for~     lactate levels and ScvO2. Children instrumented with arterial and central venous catheters~     are included within the first 12 hours after admittance.~   "
142951|NCT01696162|"~     This is a clinical research trial to evaluate the efficacy of delivering exercise therapy for~     knee pain via the Internet utilizing an algorithm designed to adjust a home exercise program~     based on user input. The investigators hypothesize that exercise therapy can be delivered~     safely and effectively with increased participant satisfaction compared to the current~     standard.~   "
142952|NCT01696149|"~     The aim of this study was to determine the effects of 4 Hz and 110 Hz transcutaneous~     electrical nerve stimulation on the sympathetic nervous system via measuring the sympathetic~     skin response (SSR) and skin temperature.~   "
142953|NCT01696136|"~     The MYSTIC_PAF trial investigates the differences between treatment with a single-tip~     catheter against a multielectrode catheter in cardiac ablation procedures in patients with~     paroxysmal atrial fibrillation.~   "
142954|NCT01696123|"~     Current therapeutic approaches for the treatment of neurodegenerative diseases like Alzheimer~     disease (AD) offer limited and often transient symptomatic benefits to patients but do not~     mitigate the insidious loss of neuronal cells. In this trial the investigators will evaluate~     Efficacy and Tolerability of MLC601 as a neuroprotective in Patients with Mild to Moderate~     Alzheimer Disease who Were Unable to Tolerate or Failed to Benefit from Treatment with~     Rivastigmine.~   "
142955|NCT01696110|"~     The study would enrolled a total of 2100 AMI patients undergoing PCI to one of three~     antithrombotic regimens: bivalirudin alone, or unfractionated heparin alone, or~     unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor.~      All enrolled patients would be followed-up to 30 days, 6 months, and 1 year. The purpose of~     the study is to evaluate the efficacy and safety of bivalirudin in AMI patients with DES.~   "
142956|NCT01696097|"~     The purpose of this study is to determine if the source of dietary protein (pork or~     chicken/fish) as a part of the DASH diet affects blood pressure control in adults with high~     blood pressure.~   "
142957|NCT01696084|"~     To confirm the efficacy of CPX-351 compared to 7+3 as first line therapy in elderly patients~     (60-75 yrs) with high risk (secondary) Acute Myeloid Leukemia. The primary efficacy endpoint~     will be overall survival.~   "
142958|NCT01696071|"~     Determine the 24-hour FEV1-profile of tiotropium solution for inhalation after 4 weeks~     treatment periods of 5 mcg tiotropium administered once daily in the evening and 2.5 mcg~     tiotropium administered twice daily (morning and evening). In addition compare the 24 hours~     pharmacokinetic profile of 5 mcg tiotropium administered once daily and 2.5mcg tiotropium~     administered twice daily in pharmacokinetic sub-investigation.~   "
142959|NCT01696058|"~     The overall objective of this study is to assess efficacy and safety of 12 weeks, once daily,~     orally inhaled co-administration of olodaterol 5 µg (delivered by the Respimat® Inhaler) and~     tiotropium (delivered by the Handihaler® as Spiriva Handihaler®), compared to tiotropium~     (Spiriva Handihaler®) monotherapy on lung function in patients with COPD.~   "
142960|NCT01696045|"~     The purpose of the study is to comply with the Pediatric Investigation Plan requirements of~     Ipilimumab~   "
142962|NCT01696019|"~     A pilot randomized clinical trial was conducted in a random sample of 120 non-demented~     Chinese elders (ages 60-79) living in a defined community in Shanghai, China to compare the~     effects of interventions (fast walking, Tai Chi, group intellectual discussion) to no~     intervention with respect to change in cognition and whole brain volume determined by~     repeated neuropsychological batteries and MRI scans. Aims included determining the~     feasibility of recruiting and retaining a random sample of people age 60+ for such a trial as~     well as collection of preliminary data on the efficacy of the interventions. The long-term~     goal of this research program is to determine whether sustained physical and/or mental~     exercise interventions are efficacious in delaying the onset of dementia and to understand~     the role and mechanisms of brain growth in this process.~   "
142963|NCT01696006|"~     The purpose of this study is to determine whether coronary perfusion computed tomography is~     effective in the treatment of coronary artery disease.~   "
142964|NCT01695993|"~     216 Chemotherapy-naïve, female breast cancer patients about to begin chemotherapy and who~     expect to have nausea, will be entered. Participants will be randomized to one of three study~     arms: Arm 1: control; Arm 2: Expectancy-neutral handout + Expectancy-neutral MP3+ acupressure~     bands; Arm 3: Expectancy-enhancing handout + Expectancy-enhancing MP3 + acupressure bands.~      Hypothesis: Acupressure bands provided with the relaxation MP3 will be effective in~     controlling chemotherapy-induced nausea~   "
142965|NCT01695980|"~     The study will compare how often the tubing kinks when a LMA (laryngeal mask airway) with~     modified retractor is used compared to use of an endotracheal tube (ETT) and non modified~     retractor is used.~   "
142966|NCT01695967|"~     patients will be placed in 2 groups, with or without turbinate cautery ( a surgical method to~     reduce the size of the skin covered bones in the nose), at the time of adenoidectomy and~     tonsillectomy. It will compare the amount of nasal congestion for each group with the idea~     that it will be less if treated with turbinate cauterization. Assessments from baseline to 6~     months post procedure will be compared between the two groups.~   "
142967|NCT01695954|"~     The main goal of this study is to determine how taking efavirenz affects the levels of~     pitavastatin in the bloodstream when both drugs are taken together and to see how darunavir~     with ritonavir affects the levels of pitavastatin in the bloodstream. Secondary goals are to~     see how taking pitavastatin affects the levels in the blood of efavirenz when both drugs are~     taken together and to see how taking pitavastatin affects the levels in the blood of~     darunavir.~   "
142968|NCT01695941|"~     This phase I trial studies the side effects and best dose of alisertib and bortezomib when~     given together with rituximab in treating patients with mantle cell lymphoma or B-cell low~     grade non-Hodgkin lymphoma that has returned after a period of improvement (relapsed) or does~     not respond to treatment (refractory). Alisertib and bortezomib may stop the growth of cancer~     cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as~     rituximab, may interfere with the ability of cancer cells to grow and spread. Giving~     alisertib and bortezomib together with rituximab may be a better treatment for relapsed or~     refractory mantle cell lymphoma or B-cell low grade non-Hodgkin lymphoma.~   "
142969|NCT01695928|"~     The low-energy extracorporal shockwave is a scientifically approved method to activate~     respectively increase bone-turnover processes especially in orthopedic medicine. The aim of~     this clinical study is to apply this effect in orthodontic dentistry and evaluate the~     orthodontic tooth movement respectively miniscrew stability clinically.~      This randomized clinical study is carried out in orthodontic patients undergoing space~     closure therapy at the university clinic of dentistry. During this period the tooth movement~     rate as well as the miniscrew stability are evaluated consecutively chairside.~   "
142970|NCT01695915|"~     The purpose of the study is to determine the diurnal variation of rectal diameter in healthy~     and constipated children using transabdominal ultrasound.~   "
142971|NCT01695902|"~     The primary objective of this study was to compare the efficacy of Test Product (Levosert)~     vs. Reference Product (Mirena® Bayer-Schering) based on the mean variation of menstrual blood~     loss volume in women with menorrhagia.~      The secondary objectives includes physical and gynaecological examinations, vital signs,~     clinical laboratory tests including hemoglobin and ferritin measurements, body weight and~     spontaneously reported adverse events were analysed and compared between Levosert and Mirena®~     treatment arms. Plasma levels of levonorgestrel (LNG) were also evaluated after various~     periods of time. The residual amounts of LNG in the devices were finally measured after~     withdrawal at completion of the study. Plasma levels of LNG and residual amounts of LNG were~     compared between the two treatment groups. Contraceptive effect of Levosert was estimated by~     Pearl Index.~   "
142972|NCT01695889|"~     The purpose of this study is to compare exposure to general anesthesia between cases with a~     diagnosis of Alzheimer´s disease and controls without diagnosis, through studies of medical~     records. The investigators wish to explore if there is a relationship between exposure to~     general anesthesia and the development of Alzheimer´s disease.~   "
142973|NCT01695876|"~     Study to evaluate the safety, tolerability, PK, PD, and food effect of AMG 357 in healthy~     subjects~   "
142974|NCT01695863|"~     This study will be comparing patient satisfaction, efficacy comparing miralax with gatorade~     versus Movi Prep for outpatient colonoscopy.~   "
142975|NCT01695850|"~     The objective of this study is to evaluate the efficacy and safety of a Chinese herbal~     proprietary medicine, MaZiRenWan (MZRW), by comparing with stimulant laxative western~     medicine (WM), senna, and placebo for patients with functional constipation (FC) in excessive~     TCM syndrome.~   "
142976|NCT01695837|"~     The purpose of this study was to evaluate the effects on lipids and diet of a low-intensity~     dietary counseling intervention provided by the primary care physician (PCP), in patients at~     risk for cardiovascular diseases~   "
142977|NCT01695824|"~     The primary objective of this study is to assess combined end point (All stroke, Systemic~     embolism, Cardiovascular death) between two groups.~   "
142978|NCT01695811|"~     The purpose of this study will be to determine optimal surgical technique for performing FLAK~     including laser parameters, keratoplasty shape and suture technique in order to standardize~     surgical technique and to collect safety and efficacy data. This will be compared to data of~     patients with full thickness PKP to measure visual outcomes, refraction, astigmatism,~     surgical methods and wound healing.~   "
142979|NCT01695798|"~     Chronic malnutrition is associated with lack of effective gut immunity which is a possible~     explanation for why we see polio cases among a proportion of children who have received 7 or~     more doses of OPV.Our proposed idea is to evaluate if IPV antigen given later in life may act~     together to boost humoral and mucosal immunity in children belonging to low-income background~     in Karachi who have moderate to severe chronic malnutrition (height for age Z score less than~     -2SD). We also intend to compare eIPV + OPV with OPV only in non-malnourished infants at 9~     -12 month of age. Thus, the proposed study is a combination of two trials, with study~     population stratified by nutritional status, each with a reference arm (bOPV) and an~     experimental arm (bOPV plus IPV).~   "
142980|NCT01695785|"~     Little is known regarding the relationship between perceived and physiological exertion in~     adolescents. The purpose of this study is to investigate the association between~     physiological and perceptual markers of effort during exercise and the relationship of these~     markers to other health-related behaviors in healthy weight and obese adolescents.~   "
142981|NCT01695772|"~     This open-label, single arm, multicenter study evaluated the resection rate in participants~     with colorectal cancer and previously untreated unresectable liver-only metastases after~     adding bevacizumab to 5-FU based doublet chemotherapy in the neoadjuvant setting.~     Participants receive standard 5-FU based chemotherapy plus Avastin bevacizumab 5 milligrams~     per kilogram (mg/kg) every 2 weeks for a maximum of 12 cycles combined pre- and~     postoperatively, unless they experienced progressive disease or unacceptable toxicity.~   "
142982|NCT01695759|"~     To evaluate the clinical efficacy and immunogenicity of the drug test Eritromax ® - (rHuEPO~     Blau) compared to drug Eprex ® (Janssen-Cilag rHuEPO) in the treatment of patients who have~     anemia secondary to chronic kidney disease (CKD), during the correction through assessing the~     change in hemoglobin levels.~   "
142983|NCT01695746|"~     This observational study will evaluate the use in clinical practice and efficacy of Mircera~     (methoxy polyethylene glycol-epoetin beta) in stage III-IV chronic kidney disease patients~     not on dialysis receiving Mircera for the treatment of chronic renal anemia. Eligible~     patients will be followed for 24 weeks.~   "
142984|NCT01695733|"~     This clinical trial studies the best time to administer the influenza vaccine to patients~     with non-hematologic malignancies receiving chemotherapy. Giving the vaccine at different~     times relative to chemotherapy may affect how well it works to help the body build an immune~     response and prevent influenza in these patients.~   "
142985|NCT01695720|"~     The purpose of the study is to accumulate efficacy data on VisionScope Imaging (VSI) for~     pre-operative diagnosis of certain knee injuries (meniscal and articular cartilage injuries).~     The study will compare VSI's accuracy to MRI's in diagnosing the same injuries.~      The hypothesis is the VisionScope Imaging system will be able to provide direct visualization~     and diagnostic images of inside the joint capsule space without fluid distention in the knee.~     This study will provide valuable feedback on the ability of the VisionScope system to provide~     physicians with the information they need to make a definitive diagnosis.~   "
142986|NCT01695707|"~     Many patients with eczema (atopic dermatitis) have an inherent defect in their skin barrier~     as demonstrated by high water loss. In laboratory conditions, studies have shown that~     pioglitazone restores the skin barrier function in skin from eczema patients. The purpose of~     this study is to determine if taking pioglitazone improves the skin barrier function in~     people with eczema.~   "
142987|NCT01695694|"~     The purpose of the study is to test the feasibility, acceptability, and efficacy of an~     adapted intervention that is theoretically and empirically guided by the~     Information-Motivation-Behavioral skills model (IMB) and aims at reducing sexual risk~     behavior among women who have experienced Intimate Partner Violence (IPV), as well as such an~     intervention.~   "
142988|NCT01695681|"~     The purpose of this study is to determine the prevalence of previously undiagnosed coeliac~     disease based on a health survey from Tromsø, Norway. Moreover, the health impact of~     undiagnosed coeliac disease will be examined.~   "
142989|NCT01695668|"~     The purpose of this research is to:~        1. Evaluate the safety and efficacy of a steroid eye drop (Lotemax) in patients who have~          been diagnosed with graft-versus-host disease (GVHD), which is a complication that may~          occur after bone marrow transplant where the newly transplanted material attacks the~          patient's body and may cause eye dryness.~        2. Assess the safety and efficacy of Lotemax in decreasing the eye's reaction to the~          process in GVHD before the patient undergoes bone marrow transplant.~        3. Compare how well Lotemax works in decreasing the process in GVHD with an~          immunosuppressive eye drop (Restasis), which has been commonly used in the treatment of~          this condition.~   "
142990|NCT01695655|"~     Corneal transplantation is the most commonly performed human tissue transplant worldwide.~     Over 40,000 corneal transplants occur in the US each year. .~      This study will determine specific corneal neovascularization (CN) patterns in human corneal~     allograft recipients to determine the characteristics that worsen the prognosis for graft~     survival. We will test the hypothesis that specific characteristics of CN are prognostic for~     corneal allograft rejection.~   "
142991|NCT01695642|"~     Laser in situ keratomileusis (LASIK) is the most common corneal refractive surgery performed~     for correction of myopia. There are very few studies that have been performed to evaluate~     long-term outcomes after LASIK.~      In this study, we will assess long-term outcomes 5 - 10 years after LASIK to assess stability~     of visual outcomes and long-term effect on corneal morphology with in vivo confocal~     microscopy. Clinical and corneal morphology outcomes will also be compared between patients~     who had flaps created with the microkeratome and femtosecond laser.~   "
142992|NCT01695629|"~     Clinical in vivo confocal microscopy (IVCM) is a relatively new technique of corneal~     evaluation that permits non-invasive imaging of corneal structures on the cellular level.~     Precise anatomic characterization of corneal structures, including corneal nerves, can be~     rapidly performed with high resolution.~   "
142993|NCT01695616|"~     The purpose of this study is to evaluate the effects of Passiflora incarnata and Isoflavone~     combination in relieving the symptoms associated with Climacteric Syndrome.~   "
143036|NCT01695057|"~     This pilot clinical trial studies vorinostat before surgery in treating patients with~     triple-negative breast cancer. Vorinostat may stop the growth of tumor cells by blocking some~     of the enzymes needed for cell growth. Giving enzyme inhibitor therapy before surgery may~     make the tumor smaller and reduce the amount of normal tissue that needs to be removed~   "
142994|NCT01695603|"~     Comparison of the ability of a new automated ventilatory mode named Intellibrain to maintain~     capnia and oxgen partial pressure within predefined ranges in comparison to the control of~     capnia and oxgen partial pressure obtained by using standard controlled ventilation modes in~     brain injured patients. Comparison of the numbers of alarms and required settings~     modifications observed with each ventilatory mode.~   "
142995|NCT01695590|"~     To determine the maximum tolerated dose of, and response to, PRLX 93936 as treatment for~     patients with relapsed or relapsed/refractory multiple myeloma.~   "
142996|NCT01695577|"~     The main aim of this study is to evaluate the effect of vestibular rehabilitation and balance~     training on patients with dizziness and balance problems after traumatic brain injury.~   "
142997|NCT01695564|"~     Atrial fibrillation (AF) is the most common cardiac rhythm disorder in clinical practice. In~     the last two decades the number of hospitalizations for AF has increased two- to three-fold.~     More than 6 million people worldwide suffer from atrial fibrillation (AF), a cardiac disorder~     that results in systemic emboli. Patients with AF are 5 times more likely to have a stroke~     compared with those without AF.~      This registry will collection information on two devices that are used to treat AF. The~     WATCHMAN and LARIAT. The differences in techniques and subsequent effects of the two devices~     on outcomes related to AF has not been studied. This study will look to compare the two~     devices to see how the outcomes may vary.~   "
142998|NCT01695551|"~     Ventricular tachycardia (VT) is a life-threatening, fast heart rhythm that starts in the~     lower chambers of the heart (the ventricles). This fast heartbeat is caused by abnormal~     electrical pathways located in the heart tissue. A standard procedure called a catheter~     ablation has been used for several years to help correct these abnormal pathways and, in some~     cases, improve or even eliminate the ventricular tachycardia.~      During a VT ablation it is routine to monitor your vital signs (blood pressure, heart rate,~     and oxygen saturation in your blood). If you choose to participate in this study we will also~     monitor your cerebral oximetry, the amount of blood flow and oxygen saturation to your brain~     during the ablation.~      By doing this study, we hope to have a better understanding of patients' blood and oxygen~     flow to their brain during an episode of Ventricular Tachycardia (VT).~   "
142999|NCT01695538|"~     Inappropriate sinus tachycardia (IST) is an uncommon form of atrial tachycardia. The term~     inappropriate in medicine is commonly defined as a heart rate greater than 100 beats per~     minute at rest or with minimal physiological challenge. IST is characterized by an increased~     resting heart rate with an exaggerated response to exercise or stress.~      Yoga has been used extensively around the world as an alternative medicine approach in~     treating numerous chronic and debilitating diseases. Studies have been conducted in various~     countries to determine the benefits of Yoga as therapy for these chronic diseases. Several~     studies have confirmed that yoga can reduce anxiety and regulate the stress response.~      Studies in the past have shown that Yoga relieves stress, one of the most common triggers for~     the arrhythmia and increased heart rate in IST. Based on past studies we hypothesize that~     patients with IST might benefit by practicing yoga. Yoga may also help in better rate and~     rhythm control with yoga when employed in combination with usual medical arrangement.~   "
143000|NCT01695525|"~     Syncope is a common problem that many clinicians may encounter in various outpatient~     settings. Neurocardiogenic syncope (NCS) is a benign condition characterized by a self~     limited episode of systemic hypotension. Patients are usually managed with education on~     syncope, anxiety management, and coping skills.~      It has been established that practice of Yoga could relieve stress and anxiety. In a~     different study, they also found that Yoga positively influences cardiovascular function by~     decreasing the heart rate and blood pressure. The main objective of Yoga is to achieve~     control over the autonomic nervous system and able to control functions like heart rate,~     blood pressure and respiratory rate.~      Based on the findings that Yoga relieves stress and reduces heart rate, the investigators~     propose to study if Yoga can decrease the frequency of NCS and also reduce the symptoms~     associated with these episodes.~   "
143001|NCT01695512|"~     The aim of our prospective and multicentre diagnostic study is therefore to elucidate on the~     sensitivity and specificity rates of these serologic markers in combination with molecular~     tools (both an Aspergillus specific and a multifungal PCR based assay), as serologic mark-ers~     are not pathogen-specific, and furthermore to define species-specific cut-off values for BDG~     in BAL samples.~      Additionally, if genomic material of Aspergillus fumigatus is detected by PCR in a clinical~     sample, we investigate fungal DNA for point mutations in the cyp51A gene mediating~     resis-tance against common mould-active triazoles with novel rapid, sensitive and specific,~     non-culture-based PCR-assays and sequencing to optimize antifungal treatment as early as~     pos-sible.~   "
143002|NCT01695499|"~     The aim of this project is therefore to explore on the clinical significance of analyzing~     surrogate markers combined with conventional diagnostics in the ICU setting. BAL, blood and~     biopsy samples will be subjected to a combined analysis of GM, BDG, Aspergillus specific PCR~     assays in addition to conventional diagnostics (Microscopy, Culture,Histology) for ICU pts~     with pulmonary infiltrates.~      As GM and BDG are not species-specific, three established and repeatedly published species~     specific PCR-based assays (nested PCR, real time PCR assay, multifungal DNA Array)developed~     by our group will be investigated in combination with the serological tests in a multicenter~     prospective clinical diagnostic trial.~   "
143003|NCT01695486|"~     The purpose of this study is to compare sedation monitoring by bispectral index and comfort~     score during open muscle biopsies in children.~   "
143004|NCT01695473|"~     This is a phase II, study of BKM120 in patients with high-risk, localized prostate cancer.~     Eligible patients will be enrolled and scheduled to have an ultrasound-guided biopsy of the~     prostate to confirm high-risk disease and collect prostate tissue for analysis. Two weeks~     after the biopsy, patients will begin taking 100 mg/day of BKM120. BKM120 will be given at~     this dose level orally once daily for 14 days prior to radical prostatectomy at University of~     California, San Francisco. Radical prostatectomy will be performed on the day of the last~     dose of BKM120 at day 14. No further drug will be tken after the radical prostatectomy.~   "
143201|NCT01692899|"~     To compare retention rates of adalimumab, etanercept and infliximab as first-line biotherapy~     in rheumatoid arthritis (RA), to determine causes of discontinuation, retention-associated~     factors, and retention rates of possible second-line tumor necrosis factor α inhibitors~     (TNFi).~   "
143005|NCT01695460|"~     The trial is primarily designed to investigate whether treatment with vitamin D may influence~     migraine in a placebo-controlled, blinded study. The hypothesis is that vitamin D may serve~     as a prophylactic treatment of migraine. The hypothesis is tested by examining the changes in~     the pain and symptom patterns associated with migraine by treatment with Vitamin D, by means~     of quantitative sensory testing, diaries and blood samples for measurement of vitamin D.~     Other pain biomarkers are also measured to evaluate whether the levels of these biomarkers in~     the blood is changed by the treatment with vitamin D. The hypothesis here is that levels of~     those biomarkers will change following the treatment.~   "
143006|NCT01695447|"~     The purpose of this study is to determine whether duct-to-mucosa is better than invagination~     in pancreaticojejunostomy after pancreaticoduodenectomy. This single-centre, open, randomized~     controlled trail is conducted following ISGPF criteria for pancreatic fistula (PF). The~     duration of the study is supposed to start from Jan 5th 2012 and last to Dec 2014, until 100~     or more cases are accessible. Patients diagnosed with pancreatic cancer, peri-ampullar~     carcinoma or other benign or malignant diseases which need to operate pancreaticoduodenectomy~     will be included. Main outcomes are pancreatic fistula rate, mortality, morbidity,~     reoperation and hospital stay. The investigators assumption that duct-to-mucosa is better~     than invagination.~   "
143007|NCT01695434|"~     To explore whether treatment with glatiramer acetate (GA) may decrease iron deposition in~     subcortical deep GM, as detected by SWI-filtered phase imaging, in patients with RRMS over 24~     months and compared to a reference population of healthy controls.~   "
143008|NCT01695421|"~     Patients afflicted with Chronic Heart Failure (HF) typically do not maintain stable cardiac~     function for the remainder of their life and consequently require continuous medical~     management and intermittent hospital admissions. Several investigations have demonstrated~     that electrical muscle stimulation (EMS) produces positive physiologic and psychological~     adaptations in patients with HF. However not all the EMS modalities were been evaluated on~     this population or not even were tested based on present recognized gold standard clinical~     parameters after a short period of treatment. The primary aims of the proposed study is to:~     Determine the effect of a five week home based of three EMS modalities on prognostics~     markers, perceived quality of life, muscle force and electrical activity in subjects~     diagnosed with HF.~   "
143009|NCT01695408|"~     Idiopathic pulmonary fibrosis (IPF), a manifestation of chronic progressive fibrosing~     interstitial pneumonia,ia a rare disease. Current treatment options are limited, and the mean~     survival time of the newly diagnosed (mostly elderly) patients is only about 2-3 years. As in~     Europe data are limited on the characteristics and management of such patients, INSIGHTS-IPF~     was initiated as a new registry that documents newly diagnosed (incident) and prevalent~     patients with confirmed IPF diagnosis prospectively.The registry will contribute to the~     optimization of the management of IPF patients in the long term.~   "
143010|NCT01695395|"~     Quality of mental health services provision for adults with intellectual disability and~     comorbid mental disorder is considered inadequate and therefore in need of further~     improvement. However, empirical findings on this topic are rather scarce. The MEMENTA-study~     therefore aims to compare mild and moderate intellectual disabled adults with a comorbid~     mental disorder to mild and moderate intellectual disabled adults who do not have a comorbid~     mental disorder with respect to clinical parameters. The MEMENTA-study is an observational,~     epidemiological, cross-sectional study. A representative sample of the target population is~     realised by the assessment of approximately n=600 intellectual disabled adults working at~     specialized facilities (sheltered workshops). A cluster sampling with probability~     proportional to institution and size (n of overall employed persons) will be followed by a~     simple random sampling of persons of these clustered facilities. A number of parameters such~     as severity of mental health impairment, needs for care, quality of life (QoL), caregiver~     burden, health services utilization, and costs for care will be assessed by using a set of~     well-established standardised instruments. Quality of mental health care will be assessed and~     examined by open questions to intellectual disabled adults with a comorbid mental disorder as~     well as informal caregivers and staff of caring institutions.~   "
143011|NCT01695382|"~     Palliative care is a priority area of focus for health care in an aging population~     experiencing burdens of chronic illness. Despite the evidence-based benefits of palliative~     care, access remains limited, especially in poor urban and rural settings. Cultural and~     linguistic barriers may also increase disparities in palliative care for Latinos. Due to a~     nationwide shortage of palliative care providers and the unique cultural preferences and~     values of patients, the investigators are testing a patient navigator intervention to improve~     palliative care outcomes for Latinos with advanced cancer.~   "
143012|NCT01695369|"~     Evaluation of Comfilcon A and Senofilcon A Lenses~   "
143013|NCT01695356|"~     Melasma is an acquired discoloration of the skin characterized by brown colour changes~     commonly on the face. The duration of this double-blind clinical trial will be 12 weeks. The~     control group will receive treatment with topical Hydroquinone (4%) and a Broad spectrum UV~     sunscreen. The experimental group, 4% topical hydroquinone and a Broad spectrum UV-visible~     light sunscreen. Visible light has melanotic properties and avoiding it can be part of the~     treatment for melasma patients. The estimated number of subjects to be recruited and~     randomized for the study is at least 25 per group. The purpose of this study is determine if~     there is a difference in the improvement between these two sunscreens types. Melasma Area and~     Severity Index (MASI) score will be assessed at the beginning of the study and at weeks 4, 8,~     and 12. Photographs, colorimetry and histological assessment will be also evaluated.~     Occurrence of adverse effects will also be recorded.~   "
143014|NCT01695343|"~     The purpose of this study is to confirm and extend the Phase 1-2 KB001 findings of an airway~     anti-inflammatory effect in CF individuals with chronic Pseudomonas aeruginosa (Pa) airway~     infection. It is hypothesized that steady-state levels of KB001-A in CF subjects with airway~     Pa infection will be safe and well-tolerated, and will increase the time-to-need for~     antibiotic treatment (IV, inhaled, or oral) for worsening of respiratory tract signs and~     symptoms compared with placebo.~   "
143202|NCT01692886|"~     This study is primarily designed to evaluate the IgG immune responses to the 13 pneumococcal~     serotypes induced by 13vPnC compared with the immune responses induced by 7vPnC when measured~     1 month after the infant series, and to evaluate the acceptability of the safety profile of~     13vPnC as measured by the incidence rates of local reactions, systemic events and adverse~     events.~   "
143015|NCT01695330|"~     This is a phase 2, multicenter, open label, nonrandomized study for patients with MM who will~     receive treatment with a SC bortezomib-containing combination regimen that does not contain~     thalidomide or vincristine. The patients will be required to have received a prior IV~     bortezomib containing combination regimen that did not contain thalidomide or vincristine and~     that differs from the SC bortezomib-containing one. In between the time that the patient~     received the IV bortezomib-based combination regimen and enrollment onto this study, patients~     may have received other non-bortezomib-based regimens as long as these treatments did not~     contain thalidomide or vincristine. This study will enroll patients who have relapsed or have~     become refractory to their prior IV-administered bortezomib-containing combination regimen as~     demonstrated by progressive disease while on or following that regimen. Patients must have~     received 4 doses of a minimum of 1.0 mg/m2 of bortezomib administered IV in no more than 4~     weeks per cycle. Patients must have received at least one cycle meeting this definition and~     have shown progressive disease to be considered eligible. Patients who have relapsed or have~     become refractory to their most recent IV bortezomib-containing combination regimen are~     eligible regardless of when they received that regimen, as long as they meet the above~     criteria.~      The study will consist of a screening period, followed by up to eight open label treatment~     cycles, a final assessment to occur 28 days after the end of the last treatment cycle, and a~     follow-up period.~   "
143016|NCT01695317|"~     Traditionally, beta blockers have been used for migraine prophylaxis, but in later years also~     antiepileptic drugs. Contraindications and side effects have to some degree limited their~     use, and new prophylactics that can be used by most migraine sufferers and with little side~     effects are in demand. One product that may seem to fulfill these requirements is~     Acetyl-L-carnitine, which is a dietary supplement and naturally occurs in plants and animals.~     L-carnitine is necessary for fatty-acid metabolism and energy production.~      To our knowledge, no placebo-controlled studies have previously evaluated the efficacy of~     Acetyl-L-carnitine in adults with migraine.~      The aims of the present study is to evaluate the efficacy of Acetyl-L-carnitine as a~     prophylaxis in migraine patients~   "
143017|NCT01695304|"~     The aim of the study is to examine the efficacy of ceramic water filters to reduce the burden~     of waterborne diarrheal illness among infants in selected villages in Kenya. In Kenya very~     young children are given drinking water or water is used in reconstitution of their food. We~     hypothesize that ceramic water filters will remove Cryptosporidium from drinking water~     reducing infection in infants.~   "
143018|NCT01695291|"~     This study will examine the feasibility and potential efficacy of augmenting SRIs with~     minocycline. The study will assess whether the addition of minocycline leads to measurable~     changes in striatal glutamate (Glu) levels. This study will recruit up to 45 youth ages 8-20~     diagnosed with clinically significant OCD who have demonstrated no more than minimal response~     to SRI treatment and are currently on a stable dose of SRI medication for at least 12 weeks.~     Participants will be randomized to receive either 12 weeks of minocycline treatment or pill~     placebo. Randomization will be 2:1 so that 2 of 3 participants receive minocycline. Screening~     for eligibility will take place for 1-4 weeks. Participants will undergo MRS scans to measure~     striatal Glu levels prior to randomization, and again immediately following the treatment~     period. During the treatment period, participants will meet initially weekly and then every~     other week with the study psychiatrist. All participants will be offered three months of open~     medication treatment following participation. The clinical trial will only be conducted at~     NYSPI and the MRS scans may be conducted at Weill Cornell Medical Center or NYSPI.~   "
143019|NCT01695278|"~     Diabetes poses a substantial burden to racial/ethnic minorities and in populations with~     limited access to healthcare. However, there is a shortage of healthcare providers available~     to help patients adopt the lifestyle changes required for diabetes control. The goal of the~     present study is to evaluate the feasibility and effectiveness of a diabetes self-care~     intervention delivered by medical students to patients with poorly controlled diabetes.~     Training medical students to use proven communication techniques to help patients identify~     and overcome barriers to adopting lifestyle changes in diabetes is a novel but plausible~     strategy. The investigators anticipate that findings from our pilot study will be used to~     develop a larger study to definitively test the program's effectiveness. A long-term benefit~     of our program is that future healthcare providers are practicing the skills needed to~     promote positive lifestyle changes and provide care for chronic conditions in diverse~     communities.~   "
143020|NCT01695265|"~     Using the FEELBREATHE®, a nasal ventilatory restriction device, during an exercise test in~     treadmill, produce physiological changes in patients with Chronic Obstructive Pulmonary~     Disease (COPD).~      These changes may improve strength and endurance of the inspiratory muscles and improve~     exercise tolerance in these patients.~   "
143021|NCT01695252|"~     Providing feedback on patient progress to therapists improves clinical outcomes for patients,~     particularly those who are failing to improve with therapy. The encouraging research has been~     carried out by a small group of researchers, largely working in the United States health care~     context. The samples studied have been young people attending university counselling~     services, suffering from mild mental health disorders. The group studies are therefore not~     similar to patients seen for psychological therapy in the NHS. Also given that therapists are~     not necessarily alert to treatment failure, have an overly optimistic view of their patients~     progress even when provided with evidence to the contrary, clinical supervision may be a more~     effective method through which to provide patient informed clinical outcomes than directly to~     therapists themselves.~      We will assess if providing feedback through the supervision process is more effective than~     providing this information to therapists themselves in terms of improving clinical outcomes,~     particularly for patients who are failing to improve with routine NHS Psychological therapy.~   "
143022|NCT01695239|"~     This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to placebo~     in participants with active psoriatic arthritis.~   "
143082|NCT01694459|"~     International guidelines support the use of a full-dose heparin (anticoagulants) during~     coronary intervention. However, a lower dose of heparin may be adequate, thanks to advances~     in angioplasty techniques and the widespread use of pretreatment with two antiplatelet~     agents.~      Thus the investigators designed a study comparing safety and efficacy of standard dose~     heparin (100 UI/Kg) versus low-dose (50 UI/Kg) in patients undergoing coronary angioplasty~     who are on aspirin and clopidogrel at the time of the procedure.~   "
143232|NCT01692496|"~     Soft tissue and bone sarcomas are rare malignant tumors, which encompasses a large family of~     more than 50 histologically distinct tumor subtypes, all of which share a putative~     mesenchymal origin. In the case of soft tissue sarcomas (STS) surgical excision is the~     mainstay of treatment, but despite curative surgery, around half of patients develop distant~     metastases and die from disease. Few therapeutic approaches are currently available to~     patients with unresectable, locally advanced, or metastatic STS and only anthracyclines,~     ifosfamide and trabectedin have shown activity, with response rates of 20-40% in previously~     untreated patients. Recent and ongoing trials have investigated a variety of combination~     chemotherapeutic regimens (variously employing ifosfamide, doxorubicin, gemcitabine,~     temozolomide, vincristine, cisplatin, and dacarbazine, among others) as well as targeted~     therapies, which in some cases have yielded improvements in response rate but which have had~     little impact on survival. No other medical option is currently available, and the median~     survival of patients with soft-tissue sarcoma with non-resectable metastases is around 12-15~     months, and approximately 8 months after second line chemotherapy.~      Liposarcomas are STS which account for at least 20% of all STS in adults. They can be further~     classified into 3 histologically and biologically different subtypes: well-differentiated~     liposarcoma/dedifferentiated liposarcoma (ALT-WD), myxoid or round cell liposarcoma and~     pleomorphic liposarcoma.~      ALT-WD liposarcomas are locally aggressive rarely metastasizing tumors characterized by ring~     or giant marker chromosomes on the cytogenetic analysis and by amplification of the 12q13-21~     region on FISH (MDM2, CDK4 and HMGIC). They account for about 40% iv of liposarcomas with a 5~     year OS around 80%. In a series of WD/DD treated with several regimens response rate was~     12.5% OS 15 months and median PFS 3.6 months(95 CI: 3.3-5.9) Mixoid /round cell liposarcoma~     accounts for 45-50% of all liposarcomas. They tend to metastasize to unusual soft tissue and~     bone locations. High histologic grade with more than 5% of round cell component is associated~     with a 5-year OS of 50% approximately. They are characterized by t(23;16)(q13-14;p11) which~     leads to the fusion of CHOP and TLS genes Pleomorphic liposarcoma accounts for approximately~     5-10% of all liposarcomas, characterized by high grade features with frequent and early lung~     metastasis and cytogenetically by high chromosome counts and complex structural~     rearrangements.~      VEGF is expressed in many STS in which increased expression is associated with higher grade~     and worse prognosis.~      Pazopanib is an oral angiogenesis inhibitor that targets mainly VEGFR, PDGFR and c-kit.~     Recently the results of a phase II trial of pazopanib in STS have been published. It was a~     four-cohort 2-stages study. The liposarcoma stratum was closed after the first stage because~     of a PFS at 12 weeks of 17% (3 out of 17 patients did not progressed after 12 weeks). After~     central pathologic review, 2 other patients initially classified as other STS were found to~     have liposarcoma with stable disease at 12 weeks (5/19: 26% PFS12w), thus fulfilling criteria~     for cohort expansion. Phase II study had been completed and in phase III study patients with~     liposarcomas were excluded so therefore data on the liposarcoma cohort are inconclusive.~      Furthermore the positive results of the phase III study PALETTE have been recently~     communicated, encouraging this treatment in other sarcomas: progression-free survival (PFS)~     per independent review was significantly prolonged with pazopanib (median: 4.6 vs 1.5 months;~     HR=0.31, 95% CI 0.24-0.40; P<0.0001). The interim analysis for overall survival shows a~     statistically non-significant improvement of pazopanib vs placebo (median: 11.9 vs 10.4~     months, HR=0.83, 95% CI 0.62-1.09).~      Soluble factors associated with efficacy and toxicity of pazopanib in these patients had been~     also reported. Decreases in VEGFR2 and increase in PlGF were both associated with toxicity~     (HTA and TSH elevation) and poorer prognosis.~   "
143023|NCT01695226|"~     Cyclooxygenase-2 (COX-2) is frequently over-expressed in primary breast cancer. There is~     evidence that COX-2 inhibition exerts anti-tumor effects in breast cancer. To further~     determine the effect of COX-2 inhibition in primary breast cancer, we aimed at studying the~     changes in breast cancer tissues of patients treated with the selective COX-2 inhibitor~     celecoxib.~      In a single-centre double-blinded phase II study, breast cancer patients were randomised to~     receive either pre-operative celecoxib (400 mg) or placebo twice daily for two to three~     weeks. We collected fresh-frozen pre-surgical biopsies (before treatment) and surgical~     excision specimens (after treatment) to assess the tumor changes by use a cDNA microarray,~     which allows to study the genome-wide changes at the transcriptional level.~   "
143024|NCT01695213|"~     Thr purpose of this study is to compare the clinical and radiological results, as well as the~     femur bone density measurements of two uncemented total hip prostheses during 5 years of~     follow up.~   "
143025|NCT01695200|"~     This is a 12-week open label trial to evaluate whether omega-3 fatty acids is effective in~     reducing the severity of autism and its comorbidities.~   "
143026|NCT01695187|"~     This is a study to test the hypothesis that time to healing of a cold sore will be lower in~     the active treatment arm of the study when compared to the vehicle (placebo). Subjects with a~     history of cold sores will be enrolled and administered active treatment or placebo in a~     blinded manner. Subjects will then be followed to assess time to healing.~   "
143027|NCT01695174|"~     In the current protocol, we propose the assessment of potential beneficial effects of the~     antibiotic Xifaxan on liver biochemistries, liver related symptoms and Mayo risk score in 15~     adult and 5 pediatric patients with PSC. Adult patients will receive Xifaxan, 550 mg twice~     daily over a 12-week period. Pediatric patients with PSC whose weight is greater than or~     equal to 40 kg will receive Xifaxan, 550 mg twice daily.~   "
143028|NCT01695161|"~     The aim of the present study is to compare intraocular pressure (IOP) values assessed with~     Ocular Response Analyzer to the classical gold standard of IOP measurement, to Goldmann~     applanation tonometry by mucopolysacchyridosis-, Fabry-patients and healthy controls. We want~     to investigate biomechanical characteristics of the cornea and their influence on the~     IOP-measurements.~   "
143029|NCT01695148|"~     The purpose of this cluster-randomized trial is to examine whether daily consumption of~     β-carotene biofortified maize flour can reduce the prevalence of vitamin A deficiency and~     improve the vitamin A status and among 4-8 year old children in rural Zambia.~   "
143030|NCT01695135|"~     The purpose of this study is to evaluate the safety and efficacy of abiraterone acetate when~     co-administered with prednisone in Asian patients with metastatic castration-resistant~     prostate cancer (mCRPC) who have failed docetaxel-based chemotherapy.~   "
143031|NCT01695122|"~     The purpose of this study is to evaluate if the addition of valproic acid to standard~     platinum-based chemoradiation as definitive treatment of locally advanced Head and Neck~     squamous cell carcinoma can improve treatment outcomes, such as response rate.~   "
143032|NCT01695109|"~     Clinical experience has confirmed the anorexic effect of Glucagon-like-peptide 1 (GLP-1)~     mimetics in comparison to DPP-4 inhibitors. A possible mechanism of this effect might be~     associated with changes in food choices, as suggested by animal studies. It has been shown~     that functional magnetic resonance imaging (fMRI) of the brain is a valuable tool in obesity~     research and can be used to study the response of several brain regions to the visual~     presentation of preferred in comparison to non preferred food items and to non food items The~     aim of this study is to search for possible effects of liraglutide in comparison to placebo~     on 1. food choices and 2. changes in brain function as evidenced by fMRI in healthy~     volunteers.~      Findings of this study will help not only to get deeper insight into the mechanism of the~     anorexic effect of GLP-1 mimetics, but also into the regulation of food choices per se. In~     the future, it is planned to extend the results of this study in normal weight volunteers to~     obese diabetic subjects.~   "
143033|NCT01695096|"~     To compare Top quality embryos either day3 or day 5, Pregnancy rate and most importantly~     ongoing pregnancy rate between high humidity incubators and humidity free incubators~   "
143034|NCT01695083|"~     Abstract:~      Fatty liver most frequently corresponds to a fat overload of the liver. It is usually~     classified as alcoholic steatosis or non-alcoholic steatosis. In the case of non alcoholic~     fatty liver overload, the histological spectrum ranges from simple steatosis to~     steatohepatitis (NASH) which associates inflammation to steatosis, with a risk of progression~     to fibrosis and cirrhosis. Obese patients are at particular risk of NASH. Screening of these~     hepatic lesions is difficult especially as they may exist while the liver tests are normal.~     The diagnosis of NASH is currently done by liver biopsy, which exposes them in particular to~     the risk of hemorrhagic complications.~      Number of subjects required:~      According to the literature and data collected Louis Mourier in the recent years, the~     inclusion of 200 patients would examine 20-40 patients with severe histological steatosis and~     steatohepatitis. All patients will be included in Louis Mourier hospital.~      Follow-up: one month Search duration: 37 months Duration inclusions: 36 months The total~     duration of participation for a patient will be one month.~      Methodology:~      It is a monocentric, prospective study evaluating the value of noninvasive tests for the~     diagnosis of hepatic lesions in morbid obese patients. The open  MRI system allows access~     to MRI for all obese patients (maximum weight 250 kg). Three of such systems are available in~     France and liver pathology can be explored only on the system of Louis Mourier.~      The reference method is liver histology; studied tests are abdominal MRI, Fibroscan / CAP,~     and serum tests.~      Examinations required specifically for research Examinations required specifically for the~     research is abdominal MRI, FibroScan/ CAP and serum tests.~      Primary endpoint :~      To validate the use of abdominal MRI, the FibroScan/ CAP and serum tests for finding severe~     steatosis and / or NASH, specificity, sensitivity, positive and negative predictive values of~     these tests are calculated. The gold standard is the result of histology on liver biopsy,~     with a morphometric study of these parameters. ROC curves are used to determine the best~     compromise between sensitivity and specificity.~      The secondary endpoints were:~      Histological lesions of liver fibrosis. Quantification of abdominal fat by MRI (in the form~     of three variables of interest: quantification of the surface of the visceral fat, of~     subcutaneous fat and of intrahepatic fat assessed by the percentage loss of signal~   "
143035|NCT01695070|"~     Intrauterine growth restriction is the term used to describe a condition where an unborn baby~     does not reach its optimum size. In the short and long term, intrauterine growth restricted~     babies have a higher risk of serious disease and even death. It is well established that very~     low levels of oxygen in the baby's blood can harm the baby's health through a state known as~     oxidative stress. Currently, there is no established treatment available to treat~     intrauterine growth restriction or its complications. In experimental animal studies however,~     the naturally occuring hormone, melatonin, has been shown to significantly reduce oxidative~     stress and improve health of the unborn babies that have suffered from intrauterine growth~     restriction. This study aims to find out if the use melatonin twice per day throughout~     pregnancies affected by intrauterine growth restriction will lower the level of oxidative~     stress experienced by the unborn baby. If this is the case melatonin may help protect the~     unborn baby from damage caused by oxidative stress, this will be studied in a separate future~     study.~   "
143037|NCT01695044|"~     PSMA ADC 2301 is a Phase 2, open-label, study to assess the anti-tumor activity and~     tolerability of Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) in two~     groups of subjects with metastatic castration-resistant prostate cancer (mCRPC). One group~     comprises subjects who must have received at least one taxane-containing chemotherapy regimen~     (e.g. docetaxel, cabazitaxel). The second group comprises subjects who are cytotoxic~     chemotherapy-naïve. Subjects who are cytotoxic chemotherapy-naïve must have received and~     progressed on-, be ineligible for, refused, have an intolerance to-, or not have access to~     Radium-223. Both groups of subjects must also have received and progressed on abiraterone~     acetate and/or enzalutamide. If a subject is unable to receive abiraterone acetate and/or~     enzalutamide, Sponsor approval is required for participation in the study. Subjects will~     receive up to eight doses of PSMA ADC approximately once every three weeks.~   "
143038|NCT01695031|"~     The objective of this study is to determine the feasibility of conducting a randomized~     controlled trial to evaluate the effectiveness of an online, Emergency Department-initiated~     asthma management intervention designed to reduce asthma-related morbidity among urban~     teenagers aged 13-19 years with uncontrolled asthma. The study will examine issues around~     recruitment, participant compliance with the study protocol, Internet access, and attrition.~     Investigators will first develop a protocol for recruiting 13-19 year old patients with acute~     asthma into an ED-initiated pilot trial of an online asthma management program, describing~     recruitment and refusal rates. Investigators will measure participant compliance with the~     pilot study protocol including 4 online sessions and a 6 month survey. Investigators will~     also measure compliance of the participants parents at baseline and a six month follow up.~     Investigators will then use pilot study results to describe the intervention effect on~     selected outcomes including ED visits, asthma control as measured by Asthma Control~     Questionnaire, functional limitations, quality of life, and behavior change.~   "
143039|NCT01695018|"~     The purpose of this study is to verify the function of p16 methylation diagnostic reagents in~     early diagnosis of oral cancer.~   "
143040|NCT01695005|"~     The purpose of this study is to find a recommended dose level of LY3039478 that can safely be~     taken by participants with advanced cancer or cancer that has spread to other parts of the~     body, including but not limited to lymphoma. The study will also explore changes to various~     markers in blood cells and tissue. Finally, the study will help to document any tumor~     activity this drug may have.~   "
143041|NCT01694992|"~     The purpose of this study is to evaluate the effectiveness of a rehabilitation~     (physiotherapy) program in patients with acute ischemic stroke in Acute Vascular Unit and in~     general ward of Hospital de Clínicas de Porto Alegre, and to verify the degree of disability~     at fourteenth and third month, functional improvement at third month, the frequency of deaths~     and incidence of complications due to immobility and quantify the time spent in hospital.~   "
143042|NCT01694979|"~     The pelvic floor and diaphragm work together in many different functions. Two important~     functions are breathing and continence. The pelvic floor muscles have to lift and squeeze to~     maintain continence. Breathing, specifically breathing out, makes the pelvic floor lift. The~     investigators don't know how much the pelvic floor lifts and squeezes during different types~     of breathing out. The purpose of this study is to measure pelvic floor lift and squeeze~     during different types of breathing out.~   "
143043|NCT01694966|"~     Evaluation of the histologically proven adenoma and carcinoma detection rate in patients~     undergoing a full colonoscopy with and without mucosal contrast enhancement, obtained with~     200 mg of Methylene Blue MMX® tablets.~   "
143044|NCT01694953|"~     This is a multi-center natural history study of MNGIE (Mitochondrial NeurogastroIntestinal~     Encephalopathy). Patients will be followed over time to assess clinical symptoms. The~     investigators hope to learn more about the disease of MNGIE as well as develop useful~     measures of disease status for use in future clinical trials.~      Additional clinical centers will be listed as they become available.~   "
143045|NCT01694940|"~     The North American Mitochondrial Disease Consortium (NAMDC) maintains a patient contact~     registry and tissue biorepository for patients with mitochondrial disorders.~   "
143046|NCT01694927|"~     The aim of this study is to evaluate the use of autologous expanded mesenchymal stem cells~     intralesional transplantation as a safe and potentially beneficial treatment for patients~     with spinal cord injury.~   "
143047|NCT01694914|"~     At present, all commercially available corneal organ culture media contain foetal calf serum~     (FCS) and sometimes other compounds extracted from animals. These compounds are necessary for~     corneal cell survival but are problematic because they theoretically have risk of~     anthropozoonosis transmission, especially for new variant of CJD and the variability between~     FCS batches influence graft quality. Our laboratory research allowed in vitro and ex vivo~     validation of a new medium free compound animal. We proved its superiority over conventional~     medium containing 2% FCS for endothelial cell survival during the storage time. The goal of~     this clinical trial is now to assess its superiority in patients.~   "
143048|NCT01694901|"~     This study investigates whether general anesthesia using a Pharmacokinetic/Pharmacodynamic~     (PK/PD) -model-based index indicating the compound effect of different anesthetics leads to~     optimized outcome compared to manually controlled clinical anesthesia and computerized~     Electroencephalogram (EEG).~   "
143049|NCT01694888|"~     Midwives are responsible for documenting and keeping care facts in midwifery departments.~     Inaccurate documentation or even minute error in reporting may lead to burdensome~     responsibility for midwives. This study has been conducted aimed to compare midwifery~     students' performance before and after teaching fundamentals of documentation. In this~     quasi-experimental study, 28 midwifery students were participated. Data were collected by a~     questionnaire including a. demographic data and b. Scenarios (1) and (2) of an imaginary~     patient with physician order and a checklist contain 11 elements of documentation~   "
143083|NCT01694446|"~     Increased postprandial plasma triglycerides are associated with increased cardiovascular~     risk. Chronic consumption of carbohydrates is associated with increased levels of~     triglycerides. Very few studies have assessed the effect of acute consumption of~     carbohydrates on plasma triglycerides and lipoprotein production and clearance. The present~     study aims to assess the effects of acute administration of glucose and fructose on hepatic~     and intestinal lipoprotein production.~   "
143050|NCT01694875|"~     The objective of the clinical study is to evaluate the AHPV-GT Assay using the PANTHER System~     in cervical cancer screening.~      This objective will be accomplished in the ASC-US Study by evaluating the performance~     characteristics of the AHPV-GT Assay using the PANTHER System in a sample population of women~     with ASC-US Pap test results who were 21 years of age or older (≥21 years of age) at the~     time of their Pap visit. For the Adjunct Study, this objective will be accomplished by~     evaluating the ability of the AHPV-GT Assay using the PANTHER System to identify women at~     increased risk of cervical disease in a sample population of women with negative~     (NILM)cytology results who were ≥30 years of age at the time of their Pap visit.~   "
143051|NCT01694862|"~     The overarching aim of the Integra Initiative is to strengthen the evidence base on the~     impact of integrating family planning (FP), postnatal care (PNC) and HIV services in~     sub-Saharan Africa. Specifically, in the study the investigators aim to test the following~     hypotheses:~      the provision of integrated services, compared to separate services, will:~        1. lead to increased uptake of a range of SRH services .~        2. attract a greater number and diversity of clients.~        3. lead to increased quality of a range of SRH services~        4. lead to healthier sexual and reproductive behavior.~        5. lead to reduced stigma at health facilities.~        6. lead to the more efficient use of resources, with a lower unit cost of provision of key~          services.~      For the purposes of this study integration is defined as offering clients both HIV and~     postnatal care (PNC) or HIV and family planning (FP) services in the same visit.~      To better understand how services can be integrated in different countries this study focuses~     on two key models of integration in Kenya and Swaziland.~        -  The first model focuses on integration of FP and HIV services (integrated FP model) and~          entails performing HIV testing, STI screening and management, cervical cancer screening,~          condom promotion within FP consultations, as well as active referral to antiretroviral~          (ART) units for HIV-positive clients. The FP model will be evaluated in Kenya only.~        -  The second model focuses on integration of PNC and HIV services (integrated PNC model)~          and will be implemented in both Kenya and Swaziland. The model focuses on the provision~          of PNC services to mother and baby, FP services, repeat HIV testing for mother, HIV~          testing for infant and referral to HIV services for HIV positive mothers and infants, as~          well as referrals for clients requiring other additional services.~   "
143052|NCT01694849|"~     Abdominal obesity and type-2 Diabetes are associated with chronic liver disorders resulting~     from the accumulation of fat in the liver (steatosis), which may progress towards hepatitis~     and possibly lead to cirrhosis and liver cancer. NAFLD (Non Alcoholic Fatty Liver Disease) is~     considered as the most common form of chronic liver disease in adults in the United States,~     Australia, Asia and Europe. In the USA, the estimated prevalence of NAFLD is 20-30% of the~     adult population.~      Non-alcoholic Steatohepatitis (NASH) is a progressing form of NAFLD, which corresponds to~     hepatic steatosis associated with inflammation and liver cell injury upon microscopic~     examination of a liver biopsy. This condition may lead to advanced fibrosis and cirrhosis and~     deserves serious medical management. Up to now, there is no effective drug which has clearly~     demonstrated therapeutic efficacy which may help lifestyle and dietary recommendations in the~     resolution of NASH.~      In this context, GENFIT is developing a new liver targeted drug candidate, GFT505, for the~     treatment of NASH and the reduction of multiple cardiometabolic risk factors associated with~     the metabolic syndrome and type 2 Diabetes.~      This phase IIb study will evaluate the efficacy and safety of GFT505 80mg and 120mg once~     daily for 52 weeks on the reversal of NASH without worsening of fibrosis, based on liver~     biopsy assessments.~   "
143053|NCT01694836|"~     Specific immunotherapy for IgE mediated sensitization to birch pollen. Long-term study to~     assess safety and efficacy of Depigoid(R)Birch 5000 - a modified pollen extract of Betula~     alba (Birch) - versus placebo.~   "
143054|NCT01694823|"~     In this study,the Autologous chondrocyte implantation (ACI)technology and cell sheet~     technology are used to Cells Sheet-Autologous Chondrocyte Implantation(CS-ACI) for treating~     Cartilage Defects.The Safety and Efficacy Study of CS-ACI are evaluated.~   "
143055|NCT01694810|"~     The study will assess safety and tolerability of different doses of topical gel containing a~     new chemical entity, NVN1000, and the vehicle (gel without drug) applied to the face of~     healthy volunteers with high counts of Propionibacterium acnes. The test product will be~     applied once daily for 4 weeks. Exploratory measures include whether the topical product~     decreases the amount of a bacteria associated with acne (P. acnes).~   "
143056|NCT01694797|"~     The purpose of this study is to monitor adverse events, safety and tolerance Metoprolol~     Succinate Extended-Release Tablets 50 mg under fasting conditions~   "
143057|NCT01694784|"~     Most prevention efforts focus on promoting services (e.g. vaccination, screening tests).~     While some of these services have clear net benefit, many instead have possible or clear net~     harm. Currently, three quarters of services graded by the U.S. Preventive Services Task Force~     (USPSTF) have possible or clear net harm (C, I, and D services). Many of these services are~     delivered in healthcare settings at higher rates than what might be expected based on their~     potential for harm. This leads to adverse outcomes, excess costs, and missed opportunities to~     deliver more quality care. An important issue in delivering prevention messages is how to~     shift toward a focus on the appropriateness of prevention: encouraging services with clear~     net benefit and either discouraging or reducing demand for services with possible or clear~     net harm. Unfortunately, little is known about what drives overuse of potentially harmful~     screening services or how to make harms relevant to patients.~      This randomized controlled trial (RCT) of 775 patients at 4 primary care practices aims to 1)~     assess factors associated with intent to receive possibly or clearly harmful screening~     services and 2) determine whether and how patients' plans to get screened change with various~     presentations of information about harms (e.g. qualitative, quantitative, narrative, framed).~     The investigators will focus on three types of screening services: osteoporosis screening~     (previous C recommendation and now no recommendation for women < 65 years old with no~     fracture risk factors), prostate-specific antigen (PSA) screening (D recommendation for all~     men, regardless of age), and colorectal cancer (CRC) screening (C for ages 76-85).~   "
143058|NCT01694771|"~     The overall objective of this study is to assess efficacy and safety of 12 weeks, once daily,~     orally inhaled co-administration of olodaterol 5 µg (delivered by the Respimat® Inhaler) and~     tiotropium (delivered by the Handihaler® as Spiriva Handihaler®), compared to tiotropium~     (Spiriva Handihaler®) monotherapy on lung function in patients with COPD.~   "
143059|NCT01694758|"~     OPTIMISE-CEEMEA is a multinational, multi-centre, observational, prospective study which will~     include patients suffering from diabetes type 2, treated or untreated, insulin dependent or~     not insulin dependent.~      In this study we aim to explore at a primary care level whether the use of benchmarking~     against a set of guideline-based reference values on a patient basis, may improve quality of~     patient care, in particular control of diabetes, lipids and blood pressure.~   "
143233|NCT01692483|"~     The purpose of this study is to evaluate the safety and efficacy of abiraterone acetate in~     male Filipino patients with advanced metastatic castration resistant prostate cancer (CRPC)~     who have received prior chemotherapy containing a taxane.~   "
143060|NCT01694745|"~     EUROPAIN Survey is an epidemiological study aimed at assessing current clinical practices~     regarding the use of sedative and analgesic drugs in newborns admitted to NICUs or PICUs in~     different countries in Europe. This study is conducted as part of the NeoOpiod study.~      The main objective of this study is to determine the current clinical practices regarding the~     use of sedative and analgesic drugs in newborns in intensive units in different countries in~     Europe. The principal criteria are: the frequency of ventilated neonates receiving sedation~     and analgesia, the medications used for sedation and analgesia in ventilated neonates, the~     length of use of medications administered for sedation and analgesia in ventilated neonates~     and similarities and differences in sedation and analgesia practices among European~     countries.~      The secondary objectives are: a) to determine the proportion of neonatal units that have~     developed and implemented local written guidelines to provide continuous sedation and~     analgesia in ventilated newborn infants as well as to prevent and treat procedural pain, b)~     to document the published guidelines for neonatal analgesia and sedation in different~     European countries and develop consensus for common European standards that can be applied in~     all medical settings, c) to determine the frequency of use of pain assessment tools in~     ventilated newborn infants and evaluate their impact on pain management practices and d) to~     determine practices to assess and prevent withdrawal syndromes.~      The EUROPAIN STUDY is observational and therefore it will not interfere with routine~     practices of participating units. No changes in diagnostic, therapeutic or any managing~     strategy of patients are imposed by the participation in this study. This epidemiological~     study will only collect data on clinical practices in each unit. It will include all neonates~     up to a corrected age of 44 weeks post conception.~      The maximum duration of data collection for every included infant is 28 days. Data collection~     will stop before 28 days if the infant leaves the unit (discharge, death, transfer to another~     hospital). Data will be entered on a secure web-based questionnaire.~   "
143061|NCT01694732|"~     Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease of the bronchi~     with an increasing prevalence. By 2020, the mortality related to COPD is expected to become~     the 3rd leading death worldwide. COPD is caused by smoking in approximately 90 % of the~     cases. Nevertheless, COPD remains under-diagnosed and more than half of patients remain~     active smokers. Brittany is the second region of France facing an abnormal high death rate~     related to COPD. Smoking cessation is the most effective therapeutic approach to reduce the~     evolution of the disease, the frequency of the exacerbations and the the mortality. Besides,~     smoking cessation is associated with a reduced risk of cardiovascular events and cancer.~     Given the COPD patients' strong addiction, smoking cessation is not easily obtained in such~     population. Furthermore, smoking cessation has been underestimated in several studies. Most~     of these studies evaluated various methods of smoking cessation in COPD patients performed~     after an exacerbation, which has a hospitalization related mortality of approximately 10%.~     Thus, there is an urgent need to find effective pharmacotherapies to help COPD patients to~     cease smoking. Varenicline, a partial agonist at a4ß2 nicotinic acetylcholine receptors is~     reported to be one of the most effective pharmacotherapies for smoking cessation. However, it~     has never been evaluated at the acute phase of an exacerbation of COPD requiring~     hospitalization.~   "
143062|NCT01694719|"~     The purpose of this study is to evaluate the potential effects of a cognitive training~     program when combined with a particular form of psychotherapy (behavioral activation therapy)~     for depression. Behavioral activation therapy targets changes in behavior as a method for~     improving a depressed individual's thoughts, feelings, and overall quality of life. This~     study is designed to test whether a computerized brain exercise called cognitive control~     training can enhance the effects of a 5-session behavioral activation therapy program. CCT~     has been shown to reduce depressive symptoms in two other studies, but it has not yet been~     combined with behavioral activation therapy. The investigators hypothesize that individuals~     assigned to the behavioral activation plus cognitive control training condition will~     demonstrate reduced depressive symptoms from pre to post treatment compared with those~     assigned to the behavioral activation plus computerized control condition. The investigators~     hypothesize that these gains will be maintained at one-month follow up.~   "
143063|NCT01694706|"~     The primary objective of this trial is to investigate the effect of food and of gastric pH~     increase on the relative bioavailability of faldaprevir.~   "
143064|NCT01694693|"~     Database analysis:~        -  To describe how Orencia is prescribed in France in Rheumatoid Arthritis (RA)~        -  To describe joint population of Orencia~        -  To assess the impact of the treatment on health status of the treated population as~          assessed by morbid-mortality criteria~        -  To describe therapeutic strategies and use of health services~   "
143065|NCT01694680|"~     The purpose of the I-TEAM project is to assess whether there is a change in visual function~     and status of the retina after a year of intervention in subjects with early signs of~     Age-related Macular Degeneration.~   "
143066|NCT01694667|"~     The proposed study is an internet-based, randomized, double-blind, placebo-controlled trial~     which will assess changes in hyperactivity in children ages five through eight with an autism~     spectrum disorders (ASD) and elevated levels of hyperactivity. In order to answer this~     question, this study will assess changes in hyperactivity as measured by the Aberrant~     Behavior Checklist (ABC) in children with ASD and elevated baseline levels of hyperactivity~     who are randomly assigned to use 1.3 grams of omega-3 fatty acids daily compared to placebo.~     The overwhelming majority of study procedures, including recruitment, informed consent,~     assessment of inclusion and exclusion criteria, and collection of baseline and outcome~     measures will take place over the internet.~   "
143067|NCT01694654|"~     1. To determine the incidence, prevalence and long-term outcome of patients with SFTP in~          the German spoken part of Switzerland.~        2. To define the role of immunohistochemical and molecular techniques, such as~          immunostaining, FISH and mutational analysis regarding their ability to predict~          malignant behavior in terms of prediction of overall survival and disease-free survival.~   "
143068|NCT01694641|"~     A multiple pregnancy is an undesired outcome of assisted reproduction. Current embryo~     selection technologies are inefficient in identifying the embryo with the highest~     implantation potential. Time lapse (TL) embryo monitoring provides additional information~     about embryo development and therefore may aid embryo selection. The investigators aim is to~     study whether TL monitoring is superior to traditional embryo observation when a single~     blastocyst is selected for transfer (ET).~   "
143069|NCT01694628|"~     The purpose of this study in patients with advanced COPD and depression is twofold:~        1. Determine the feasibility and acceptability of a 6-session e-counseling intervention~        2. Determine the efficacy of the e-counseling intervention on depressive symptoms~      We hypothesize that patients who participate in e-counseling will have improved depressive~     symptoms compared to patients receiving usual care at 8 weeks.~   "
143084|NCT01694433|"~     The purpose of this study is to study the effects of topical Vitamin D cream (Calcipotriene,~     also known as Dovonex) on the face and on the bacteria that cause acne. The information~     gained from this study may lead to new treatments for acne. In this study, Calcipotriene will~     be compared with a placebo, a cream that looks like Calcipotriene, but contains no active~     ingredients.~   "
143070|NCT01694615|"~     Lung transplant recipients undergo bronchoscopy with biopsies for clinical indications and~     for surveillance in the diagnosis of acute rejection using standard transbronchial forceps.~     It is recognized that standard forceps biopsies underestimate the presence or degree of~     airway rejection due to crush artifact and sample size. Transbronchial cryobiopsies have been~     shown in the literature to provide larger samples without crush artifact in a safe fashion in~     lung cancer patients. The aim of this study is to determine if transbronchial cryobiopsy is~     superior to standard transbronchial forceps biopsies in regards to sample size, architecture~     and the diagnosis of early rejection in lung transplant recipients which if discovered~     earlier may improve survival.~   "
143071|NCT01694602|"~     The overall aim of this research is to develop a non-invasive approach to evaluate the~     production of 3-methylhistidine (3MH)in cancer patients, as a potential means of determining~     which patients are at high risk for future development of cancer induced skeletal muscle~     atrophy.~      Rationale: The approach is based on the hypothesis that after an oral dose of deuterated~     3-methylhistidine (D-3MH), the slope of the terminal portion of the decay curve (> 12 hours~     post-dosing) for the tracer/tracee (D-3MH/3MH) in the free 3MH pool is proportional to the~     rate constant for myofibrillar protein degradation and can be determined from spot urine~     samples.~   "
143072|NCT01694589|"~     We hypothesize that administration of LDE-225 in humans with pancreatic cancer will result in~     inhibition of paracrine HH signaling in the pancreatic tumor stroma while having no effect on~     autocrine signaling in the tumor cell compartment. Furthermore we hypothesize that treatment~     with LDE-225 will result in changes in the tumor stroma (decreased desmoplasia, increased~     vascularity) that will result in improved tumor blood flow.~      The purpose of this study is to determine if, where and how LDE-225 works in pancreatic~     cancer. A cancer cell's growth can depend on the cells and tissue around it. The cells and~     tissue make chemical signals to influence the cancer's growth. This research study is~     evaluating LDE-225 designed to interfere with one of the growth signals causing pancreatic~     cancer growth.~   "
143073|NCT01694576|"~     By this clinical trial, the investigators are trying to give an answer to such a question.~     Whether NPC patients staged N2-3M0 need adjuvant chemotherapy consisting of paclitaxel and~     platinum after concurrent chemoradiation?~   "
143074|NCT01694563|"~     The primary objective of this post-approval study is to evaluate the clinical outcomes in a~     cohort of patients with non-paroxysmal forms of atrial fibrillation (persistent or~     long-standing persistent) treated during commercial use of the AtriCure Synergy Ablation~     System by physicians performed the Maze IV procedure.~   "
143075|NCT01694550|"~     The aim of this study is to examine a correction term for an adapted QT interval during~     ventricular pacing (right, left and biventricular pacing) to obtain valid formulae correcting~     for the QT intervals in various pacing conditions.~   "
143076|NCT01694537|"~     DLBS1033 is bioactive protein fraction which extracted from Lumbricus rubellus earthworm.~     This earthworm comes from Pengalengan, West Java, Indonesia. DLBS1033 possesses 8 major~     proteins with molecular weight below 100 kDa, so its named as Lumbricus Low Molecular weight~     Proteins (LLP). This enzym can be transported to the bloodstream via intestinal epitel.~     Structure of DLBS1033 looks like lumbrokinase. Lumbrokinase is enzym that consist of 6~     isoenzyme serine protease. As a drug that consists of serin protease enzym, suspected that~     the mechanism of action of DLBS1033 similar with lumbrokinase, especially as plasminogen~     activator in fibrinolytic system. In vitro study by Trisina et al showed that DLBS1033 has~     fibrinogenolytic activities on fibrinogen α, beta, and gamma chain, decreasing platelet~     aggregation and clotting time was prolonged. Until now, the mechanism of action and effects~     of DLBS1033 on human fibrinolytic and coagulation system still unknown. Therefore, the aim of~     this clinical trial is to evaluate the effects of DLBS1033 on human fibrinolytic and~     coagulation system on healthy subjects.~   "
143077|NCT01694524|"~     Few studies dealing with the risk of infectious of nervous system and the utility of lumbar~     puncture and of emergent neuroimaging among patients with simple febrile seizure between 3~     and 11 months age and with complex seizure has been reported. None of these studies was~     multicentric. Recommendations about management of these children are heterogeneous.~      The investigators aim to study by an observational retrospective multicentric study the rate~     of infectious of central nervous system among patients with a complex febrile seizure and~     among patients between 3 and 11 months age with simple febrile seizure.~   "
143078|NCT01694511|"~     The purpose of this study is to determine whether High Resolution Magnification Endoscopy~     (HRME) and Computed Virtual Chromoendoscopy (CVC) with targeted biopsies is superior to~     conventional white light endoscopy (WLE) with 4 quadrant biopsies of the metaplastic~     epithelium every 1-2 cm (Seattle Protocol) for detection of pre-malignant lesions in patients~     with Barrett's Esophagus (BE).~   "
143079|NCT01694498|"~     The purpose of the study is to investigate the efficacy and safety of two different dose~     levels of desmopressin orally disintegrating tablets against placebo for the treatment of~     nocturia in adult men during 12 weeks treatment~   "
143080|NCT01694485|"~     This is a randomized, double blind, placebo controlled, parallel group, multiple dose study~     to evaluate the efficacy of AMG 181 compared with placebo as measured by the proportion of~     subjects in remission (total Mayo Score < 2 points with no individual subscore > 1 point) at~     week 8. After completing all screening assessments and meeting all eligibility criteria,~     subjects will be randomized to receive placebo or AMG 181 at various doses per protocol. A~     maximum of approximately 50% of subjects with any prior anti-TNF agent use will be allowed in~     the study. At the end of the double blind period, subjects will enter an open label period~     during which all subjects will receive open label AMG 181 at a single dose level according to~     protocol. Subjects who failed to achieve a response at week 8 and also have an inadequate~     response at week 12 or after are eligible to enter the open label period of the study early.~     Subjects who achieved response and/or remission at week 8 and subsequently experience disease~     worsening are eligible to enter the open label period early ONLY if a confirmatory~     rectosigmoidoscopy confirms disease severity as defined by protocol. Subjects that complete~     the open label period or early terminate from the study will enter the 2 year safety follow~     up period.~   "
143081|NCT01694472|"~     The purpose of this study is to evaluate the clinical safety and preliminary efficacy of~     MAGE-A4 TCR Gene-Modified T lymphocytes in the treatment of malignant solid tumor patients,~     such as malignant melanoma and lung cancer.~   "
143085|NCT01694420|"~     This is a multicenter, single arm, 48-week open-label study of FDC ELV/COBI/FTC/TDF~     [Stribild] in acute HIV infection. Study sites will be members of the Duke-UNC Acute HIV~     Infection Study Consortium. Participants will be enrolled for 96 weeks. Clinical care and~     study drug (ELV/COBI/FTC/TDF) will be provided for the first 48 weeks. After week 48,~     clinical care but not study drug will be provided through week 96. A study participant~     suppressed at week 48 can continue on FDC ELV/COBI/FTC/TDF.~      The primary hypothesis is that once daily fixed-dose combination elvitegravir (ELV),~     cobicistat (COBI), emtricitabine (FTC), and tenofovir disoproxil fumarate (TDF) will rapidly~     reduce viral replication to <50 copies RNA/ml in participants with acute HIV infection. The~     secondary hypotheses to be considered are 1) virologic response rates as measured by plasma~     HIV RNA levels will be non-inferior or superior to a historical group of participants from~     the PHI cohort treated with EFV/FTC/TDF, 2) compared to historical controls treated with~     EFV/FTC/TDF, plasma HIV RNA will decrease more rapidly in PHI participants treated with~     ELV/COBI/FTC/TDF, 3) compared to historical controls treated with EFV/FTC/TDF, immune~     activation as measured by the proportion CD4+ and CD8+ cells expressing HLA-DR and CD38+ will~     decrease more rapidly in PHI participants treated with ELV/COBI/FTC/TDF, 4)in a subset of~     participants samples will be obtained from compartments such as the gastrointestinal tract,~     and lymphoid tissues to assess changes over time in parameters such as HIV-1 RNA, immunologic~     responses to HIV, and tissue and anatomic reservoirs. We hypothesize that treatment with the~     ELV/COBI/FTC/TDF will demonstrate improved viral clearance in these compartments as compared~     to historical controls treated with EFV/FTC/TDF. 5) in a subset of participants who remain~     suppressed on therapy, resting CD4 cells with replication-competent HIV-1 (latent reservoir)~     will be quantitated and compared to similar measurements in PHI participants treated with~     EFV/FTC/TDF. In addition, we will compare these results to those measured in HIV-1 infected~     participants treated and 6) ELV/COBI/FTC/TDF will be well tolerated, and the proportion of~     participants who require treatment modification will be less than that observed in~     participants treated with EFV/FTC/TDF.~   "
143086|NCT01694407|"~     This prospective, double-blinded, randomized, parallel cohort study will examine the genital~     and systemic safety, pharmacokinetics (PK), pharmacodynamics (PD), disintegration and~     disappearance times, and acceptability of four vaginal tablets: 1) Tenofovir (TFV) alone; 2)~     Emtricitabine (FTC) alone; 3) TFV combined with FTC; and 4) placebo. Participants will be~     randomized to treatment group, to number of tablets to be inserted in the Single Use Phase (1~     tablet or 1 tablet followed by a second tablet two hours later to mimic the BAT24 dosing~     regimen), and to one of four collection time points (2, 4, 6, or 24 hours after tablet~     insertion) for assessments only after the last dose of the Multiple Use Phase.~      In the Single Use Phase of the study, the participant will insert one tablet in the clinic to~     estimate times to disintegration and disappearance. Those randomized to two tablets will~     insert a second tablet 2 hours later. In all women, sample collection will occur 5 hours~     after the initial tablet insertion.~      In the Multiple Use Phase of the study, participants will insert a tablet once daily for 14~     days. The 1st, 7th, and 14th tablets will be inserted in the clinic; the remaining tablets~     will be inserted at home. The clinic will call the participant on day 3 of the multiple use~     phase to ask about any symptoms the participant may be experiencing. Each insertion in the~     clinic will be followed by sample collection and, at Visits 4 and 6, colposcopy at the~     participant's assigned time point.~   "
143087|NCT01694394|"~     The primary objective of the study is to determine the rate of detection of sub-clinical~     atrial fibrillation (≥ 5 minutes)within an average of 12 months following implant of the St.~     Jude Medical Confirm(R) Implantable Cardiac Monitor in patients with known cardiovascular~     risk factors and left atrial enlargement, but without prior AF.~   "
143088|NCT01694381|"~     Single-chain urokinase-type plasminogen activator (pro-urokinase) is a highly effective~     thrombolytic drug. At pharmacologic concentrations however, pro-urokinase is converted to~     urokinase - a non specific thrombolytic, limiting its therapeutic use. Mutant pro-urokinase~     (M5) is more stable and its conversion to urokinase is inhibited by C1-inhibitor.~      The primary objectives of the study are:~        -  To assess the overall safety and tolerability related to systemic plasminogen activation~          of single doses of M5 over a wide dose range (study part I).~        -  To assess the effect of single doses of C1-inhibitor on the overall safety and~          tolerability of single doses of M5 and its effect on M5-induced coagulation changes~          (study part II).~   "
143089|NCT01694368|"~     To characterize atherosclerotic coronary artery plaques using advanced intra-coronary imaging~     with a combined near-infrared spectroscopy and intravascular ultrasound catheter before and~     after percutaneous intervention~   "
143090|NCT01694355|"~     It is well known that postmenopausal women are at risk for osteoporosis. The study hypothesis~     is that vitamin D deficiency (≤17.5nmol/L) is frequently associated with osteomalacia and~     will cause low BMD estimation in DXA scan due to insufficient bone mineralization.~      We assume that among these postmenopausal women, Vitamin D treatment will improve bone~     mineralization and will cause a rapid increase in BMD. According to the results,~     bisphosphonates therapy may be an unnecessary treatment.~      The objective of this study is to evaluate the impact of severe vitamin D deficiency and its~     correction on Bone Mineral Density (BMD) in postmenopausal women.~   "
143091|NCT01694342|"~     Telomerase, through its regulatory function on telomere length may play an important role in~     immune function, cellular replicative life span, and carcinogenesis. Non-alcoholic fatty~     liver disease (NAFLD) is considered a benign condition, but in some cases, it may progress to~     cirrhosis and hepatocellular carcinoma. The risk factors for that evolution are not fully~     understood.~      Our group showed in a previous study, that hTERT mRNA expression is lower in peripheral~     lymphocytes of patients with fatty liver, compared to healthy controls. This finding could~     explain the telomere shortening found previously in these patients by our group [20] and~     others [21]. Furthermore, we found higher rates of TC in these patients, probably due to an~     attempt to counteract the shortening of the telomeres and to stabilize them. This is through~     a different mechanism that is not telomerase-mediated.~      Telomere capture is considered an alternative way to maintain telomere length and chromosomal~     stability [3]. It is a more common mechanism for chromosome stabilization and repair, in~     contrast to the telomerase-mediated process of chromosome healing and elongation This study~     aimed to evaluate mechanisms of telomere homeostasis like telomere shortening, telomerase~     activity, telomere capture and aneuploidy in patients with NAFLD in order to explain previous~     findings of telomere shortening in these patients.~   "
143092|NCT01694329|"~     The objective of this study is to document the residual burden of acute upper respiratory~     infections (AURIs), acute lower respiratory infections (ALRIs), otitis media (OMs) and~     auditory functional and anatomical abnormalities in children under the age of 5 years in~     Nunavik who will be exposed to PHiD-CV in combination with PCV-7 or PCV-13. The comparison~     groups will be the cohorts of children who received no PCV vaccine (those born in 1994-1996)~     and those exposed to PCV-7 exclusively (those born in 2003-2007).~   "
143130|NCT01693835|"~     Observational, non randomized study aimed at measuring the circadian rhythms in the urinary~     concentrations of physiological modified nucleosides in 30 patients with metastatic~     colorectal cancer and in 30 age and sex-matched healthy subjects.~   "
143093|NCT01694316|"~     The present study will explore the effectiveness of a computer based neurobehavioral~     intervention in alleviating symptoms and improving emotion regulation in veteran's with PTSD.~     It will increase understanding of psychopathology at a neural-circuit level and aid~     development of new non-pharmacological treatment for PTSD. The study is managed by the Etkin~     Lab at Stanford University in California, but participants from the entire US are welcome to~     participate as the study is delivered online.~   "
143094|NCT01694303|"~     The present study will explore the effectiveness of a computer based neurobehavioral~     intervention in improving cognition and emotion regulation in a college freshmen population.~     It will increase understanding of emotion-regulation and cognition at a neural-circuit level~     and aid development of new interventions for emotion regulatory problems.~   "
143095|NCT01694290|"~     A common tool to cool people in the pre-hospital setting is the chemical ice pack. These are~     used by athletic trainers, EMS personnel, ER staff, and people in the prehosoital setting.~      The ability of these to cool a person has never been quantified, the efficiency and extent of~     cooling, as well as location of placement of ice packs is purely anecdotal. The purpose of~     this study is to determine whether strategically placed chemical ice packs will provide~     benefit to individuals subjected to heat stress.~   "
143096|NCT01694277|"~     The objective is to compare the efficacy and safety of masitinib at 12 mg/kg/day to sunitinib~     at 50 mg/day~   "
143097|NCT01694264|"~     Analysis of effect of anti-TNFα treatment on HBV reactivation among patients with systemic~     rheumatic disease, especially rheumatoid arthritis~   "
143098|NCT01694251|"~     Even during mitral valve repair procedure (MVP) for severe mitral stenosis (MS), the~     intraoperative assessment of mitral valve area (MVA) is necessary for evaluating the severity~     of MS before the repair and excluding residual MS for immediate determination of the success~     of the repair procedure and postoperative prognosis. For this purpose, several methods have~     been applied by introperative transesophageal echocardiography (TEE): pressure half-time~     (PHT) of mitral inflow Doppler and 2-dimensional (2D) planimetry methods have been widely~     used in clinical practice. However, especially after MVP, the PHT method is usually~     unreliable because it usually underestimates the MVA due to various intraoperative~     hemodynamic factors.~      The authors hypothesized that the MVA determined by 3D TEE would be more accurate than that~     by PHT during immediate post-MVP procedure in severe MS patients and comparable to~     postoperative MVA determined by MDCT. Therefore, the present study determined the MVA by~     using PHT, 3D planimetry and MDCT before and after the MVP procedure in severe MS patients~     and analyzed them to evaluate 3D TEE's utility for evaluation of MVA.~   "
143099|NCT01694238|"~     An investigation on the difference in stoma hernia frequency related to surgical technique~     when incising the fascia. All patients planned for elective colostomy formation are to be~     included. Patients undergoing rectal resection with a TME and a colostomy (Hartmann's~     procedure) for rectal cancer, abdominoperineal resection for rectal cancer or diverting~     colostomy for any reason are all included.~      The three groups for randomization are:~      A. circular incision in the abdominal wall fascia B. cruciate incision in the abdominal wall~     fascia C. mesh enforced cruciate incision in the abdominal wall fascia Primary endpoint is~     the parastomal hernia rate within 12 months from index surgery. Secondary end-points include~     clinical variables, re-admission and/or re-operation due to any stoma complication, quality~     of life and health economy analyses, at 12 months.~   "
143100|NCT01694225|"~     This study aims to establish the feasibility of using a monthly bubble package to improve~     compliance rates among women prescribed adjuvant endocrine therapy.~   "
143101|NCT01694212|"~     Diabetes has many negative effects on patients' general health. Among many other consequences~     it speeds up the cataract formation and that is why diabetic patients need cataract surgery~     very often. The known side effect of cataract surgery even in otherwise healthy patients is~     postoperative edema of the back of the eye (what causes decrease of vision), which has~     greater incidence especially in patients who have diabetic eye problems. The cause of that~     might be the intraocular inflammation which was previously demonstrated to be significantly~     more prominent in patients with untreated diabetic eye problems. Therefore we will examine if~     the 7 day use of anti-inflammatory eye drops prior to the cataract surgery prevent the~     formation of the edema of the back of the eye.~   "
143102|NCT01694199|"~     Multicenter, randomized, controlled, double-blind study to evaluate the use of 3 days of~     pulsed radiofrequency energy (PRFE) to treat pain after bunionectomy surgery.~   "
143103|NCT01694186|"~     This is a phase 3, multi-national, multi-center, randomized, masked, controlled study to~     evaluate the safety and efficacy of an injectable fluocinolone acetonide intravitreal (FAI)~     insert for the management of subjects with non-infectious uveitis affecting the posterior~     segment of the eye. Patients will be randomized to receive either a sham injection or the FAI~     insert and will be observed for three years following treatment.~   "
143104|NCT01694173|"~     Investigators purpose is to track stem cells in vivo in the type 2 diabetes mellitus patients~     after the same have been labelled with positron emission tomography tracer F18-FDG; as it is~     assumed that the therapeutic outcome will profoundly depend on the delivery of these cells to~     pancreas. Biodistribution and quantification studies will be done at 30 minutes and 90~     minutes of stem cell infusion.~   "
143105|NCT01694160|"~     The main objective of this study is to examine if paricalcitol may reduce progression of~     graft fibrosis and proteinuria in kidney transplant patients. Cyclosporine and tacrolimus~     have a detrimental long-term effect by inducing graft fibrosis. About 50% of graft losses are~     related to interstitial fibrosis. Paricalcitol is a vitamin D receptor activator indicated~     for treatment of secondary hyperparathyroidism. Paricalcitol is known to exert an~     anti-inflammatory and antifibrotic and attenuate cyclosporine-induced fibrosis. Paricalcitol~     is also shown to be renoprotective by reducing proteinuria. No randomized controlled trials~     with paricalcitol are performed in renal transplant patients examining the effect on~     proteinuria and graft fibrosis.~   "
143106|NCT01694147|"~     To investigate the possible mechanisms of pulmonary and systemic permeability change~     including cytokine, extravascular lung water index (EVLWI), and oxygenation parameters in~     patients with sepsis related acute lung injury (ALI)/acute respiratory distress syndrome~     (ARDS).~   "
143107|NCT01694134|"~     The treatment of chronic low back pain is a major objective of public healthcare, because it~     causes an important number of sick leaves. A correlation between clinical observations and an~     inflammatory discopathy has been underlined, but there is currently any reference treatment.~     In this study, the main objective is to assess the efficacy of an intradiscal injection of~     corticoids versus local anaesthetic on the treatment of pain of patients with low back pain~     associated to a Modic I discopathy.~   "
143108|NCT01694121|"~     The purpose of this study is to evaluate the effectiveness of the MEN Count intervention, an~     HIV intervention and prevention program for heterosexual Black men. The MEN Count model~     integrates HIV risk reduction and gender-equity counseling with housing and employment case~     management via multiple one-on-one sessions delivered by a peer case manager over 60-90 day~     period. MEN Count was developed and pilot tested using a CBPR approach via funding from an~     NIH R21, in Boston, MA. A more larger scale, two-armed quasi-experimental controlled trial~     design will be used to test MEN Count among Black men recruited/enrolled from an STD clinic~     and other community-recruitment methods in Washington, DC. Study participants (N=504) will be~     Black men reporting heterosexual risk for HIV [unprotected sex with a woman and 2+ female sex~     partners in the past 6 months] and either current unemployment or homeless in the past 6~     months. To evaluate the effectiveness of MEN Count, a two-armed quasi-experimental design~     will be conducted in which participants will receive either MEN Count or an attention~     comparison program similar to MEN Count in structure. We will assess program impact on~     reduction in number of unprotected sex episodes and incident cases of STI (Chlamydia,~     gonorrhea, syphilis) via survey and STI testing, respectively, at baseline and 6 and 12 month~     follow-ups. Additionally, quality assurance and process evaluation efforts will be conducted~     to ensure high quality program adherence and delivery, as well as to support program~     replication should the model prove effective.~   "
143109|NCT01694108|"~     In high-income societies the use of health care and medication is steadily increasing.~     Children have high morbidity, many visits at the general practitioner, an increasing number~     of hospitalisations, and an increasing use of medication. And, when children are ill, someone~     has to stay home to care for them. An un-explained global increase in the incidence of the~     allergic diseases eczema, wheezing, asthma and allergies means that 25% of high-income~     populations are affected. Cheap preventive measures are highly warranted. Recent studies have~     shown a positive, non-specific effect of early Bacille Calmette Guérin (BCG) immunisation on~     neonatal mortality in low-income countries and suggested a positive, non-specific effect on~     allergic disease in high-income countries. Non-specific means that the vaccine effect goes~     beyond prevention of the targeted disease, i.e. the BCG vaccine benefits the health status of~     the immunised individual in ways unrelated to protection against tuberculosis (TB). For~     instance, in a recent randomised trial in West Africa the investigators showed that the BCG~     vaccine at birth was safe in low birth weight (LBW) infants and significantly reduced~     neonatal mortality in these children, with a significant long-lasting effect on infant~     mortality in the smallest newborns with a birth weight <1.5 kg. There is an urgent need to~     explore the huge potential of the BCG's beneficial immune-stimulatory effects among children~     in high-income populations.~      Therefore, the investigators will carry out a large prospective randomised clinical trial in~     Denmark primarily designed to test the hypothesis that infants who get the BCG vaccine at~     birth experience 20% fewer hospitalisations during early childhood.~      Secondary outcomes~        1. To test the hypothesis that infants who get the BCG vaccine at birth are prescribed less~          antibiotics during early childhood than non-BCG-immunised infants.~        2. To test the hypothesis that Danish infants who get the BCG vaccine at birth develop less~          eczema, asthmatic bronchitis/wheeze and food allergy at 3 and 12 months of age:~          self-reported, diagnosed by a physician, or found at clinical examination; and are~          prescribed less anti-eczema/asthma/allergy medication during early childhood than~          non-BCG-immunised infants.~        3. To test the hypothesis that infants who receive the BCG at birth respond in paraclinical~          measures: Specific IgE, thymic gland size, leucocyte count and differentiation, monocyte~          memory, cytokine profiles, and antibody titres following immunisation against~          diphtheria, tetanus, pertussis, pneumococcus, hemophilus.~        4. To test the hypothesis that infants who get the BCG vaccine at birth respond in growth~          measures: weight, length and head circumference.~        5. To test the hypothesis that infants who get the BCG vaccine at birth respond with~          decreased morbidity: common cold, pneumonia, febrile episodes, diarrhoea and vomiting,~          acute otitis media, febrile convulsions.~        6. To test the hypothesis that premature infants with gestational age less than 37 weeks~          who get the BCG vaccine at birth have unaffected psychomotor development measures: Ages~          and Stages scores.~        7. To test the hypothesis that infants who get the BCG vaccine at birth has unaffected~          coverage with the subsequent vaccinations in the Child Vaccination Programme.~        8. To test the above mentioned hypotheses specifically in the strata of premature and~          low-birth-weight Danish infants.~   "
143110|NCT01694095|"~     Age-related macular degeneration is one of the leading causes of blindness worldwide. The~     factors that induce the progression of geographic atrophy, the advanced form of dry~     age-related macular degeneration, remain poorly understood. The aims of this study are to~     describe the natural history of geographic atrophy and identify potential risk factors~     associated with a faster spread of atrophy that may be used to develop rational therapies.~   "
143111|NCT01694082|"~     Tertiary Health Research Intervention Via Email (THRIVE; Kypri et al., 2009), originally~     utilized with Australian students, is unique in that it contains efficacious components~     derived from motivational interviewing (e.g., personalized feedback) and cognitive behavioral~     therapy (protective behavioral strategies), yet is very brief and has established efficacy.~     This study aims to test versions of THRIVE tailored to American college students. In addition~     to replicating original results with THRIVE, we will also test versions containing unique~     subsets of protective behavioral strategies to reduce alcohol consumption. The primary~     hypothesis is that versions of THRIVE will be associated with lower overall alcohol~     consumption than an assessment and brief brochure control condition.~   "
143112|NCT01694069|"~     Cystic fibrosis is an inherited disorder leading to chronic pulmonary inflammation and~     infection. A majority of people with cystic fibrosis have large quantities of bacteria~     residing in their lungs. One of the most common and harmful bacteria is called Pseudomonas~     aeruginosa.~      Patients with cystic fibrosis require frequent therapy with intravenous (I.V.) antibiotics to~     treat lung infections thought to be caused by Pseudomonas aeruginosa. One of the antibiotics~     frequently used to treat this bacteria is piperacillin-tazobactam. Piperacillin-tazobactam is~     thought to be the most effective when there is a constant level of drug in the body. The~     standard way to administer piperacillin-tazobactam is to give several grams 4 times each day~     as a 30 minute infusion. An alternative way to give piperacillin-tazobactam is by a~     continuous infusion; a continuous infusion will make it more likely that drug will remain at~     a constant level in the body. The objective of this study is to determine if administering~     piperacillin-tazobactam as a continuous infusion is more effective at treating people having~     a pulmonary exacerbation of cystic fibrosis than a standard 30 minute infusion, 4 times a~     day.~   "
143113|NCT01694056|"~     Soy protein has a high biological value, and contains several potential health-related~     nutritional factors, i.e. its amino acids pattern, biological active peptides and non-protein~     compounds such as isoflavones. In the field of obesity and blood lipids soy protein is~     well-studied and appreciated; it improves circulating blood lipids and is associated with~     weight reduction. The effect of soy on insulin resistance, glucose homeostasis and the~     metabolic syndrome is less frequently studied. However, several molecular mechanisms of~     action of soy protein make it a promising approach.~   "
143114|NCT01694043|"~     The purpose of the study is to investigate the effect of watching a television show with~     healthy food commercials, unhealthy food commercials, or neutral commercials on the~     consumption of healthy snack foods or unhealthy snack foods. There are three hypotheses: 1)~     Women exposed to a television show with commercials imbedded advertising food will consume~     more food than women exposed to a television show with non-food related commercials.~      2) Women will consume more food when exposed to a television show with commercials~     advertising unhealthy food as compared to a television show with commercials advertising~     healthy food.~      3) Women will consume the most food when exposed to a television show with unhealthy food~     commercials and have unhealthy snack foods available to consume.~   "
143115|NCT01694030|"~     The purpose of this study is to explore whether asking participants to visualise a secure~     attachment figure or a neutral event leads to differences in self-reported felt security or~     depressed mood. Furthermore, the investigators aim to explore whether it is possible to keep~     a secure prime activated over 3 days via text message visualisation tasks.~   "
143116|NCT01694017|"~     The purpose of this study is to compare clinical, economical and quality of life (QOL)~     outcomes in patients living with HIV on zidovudine/stavudine regimen and tenofovir regimen.~     This study will be an unblinded randomized trial. The first step will be empirical data~     collection for one year for calculating the incremental cost effectiveness ratio (ICER). The~     second step will be to perform a simulation model for calculating long term ICER.~   "
143117|NCT01694004|"~     Preliminary studies in humans suggest that the presence of lipids in the gut can modify~     glucose absorption. The overall hypothesis of this proposal is that long chain fatty acid~     sensing in the duodenum has a significant role in modifying nutrient (glucose and amino acid)~     absorption from the GI tract through a gut-brain-gut axis.~   "
143118|NCT01693991|"~     Research questions: Pilot study research questions: Primary: 1)Can we recruit a sufficient~     number (i.e., at least 60 patients over 9 months) and retain a sufficient proportion of both~     men and women (i.e., at least 80% at 2, 4, or 6 months post-randomization) with advanced~     cancer in all 3 trial arms to allow completion of a full study in 4 years?; 2)Is MMi~     acceptable: to a general ACP? to both men and women?; Secondary: 1)Is it feasible to complete~     the intervention in 3-4 weeks? 2)How long is it feasible to test MMi effects: 2, 4 or 6~     months post-randomization(retention rate=80%)? 3)Which recruitment strategies are most~     helpful? 4)What sample size is needed for a full study? Full-study research questions:~     Primary: Does adding the MMi to usual care (experimental group or EG) enhance meaning in life~     among newly diagnosed ACP, compared with those receiving usual care plus meetings with an~     empathic non-professional visitor (i.e., attention-control group or AC) or usual care alone~     (UC), at x months post-randomization? (time determined in pilot) Meaning in life (primary~     outcome) is defined as the belief that one's life has significance and purpose (i.e., global~     meaning) and newly diagnosed ACP is defined as the 6 months after first occurrence of,~     progression toward, or recurrence of stage III or IV cancer (TNM classification system).~     Secondary: In our future full-study, we plan to evaluate MMi effects on secondary outcomes~     such as existential wellbeing (MQOL existential wellbeing) and posttraumatic growth~     (Post-Traumatic Growth Inventory). We also plan to test a theoretical model where sense of~     meaning in life has a protective (moderating) effect on tertiary outcomes such as physical~     QoL (MQOL physical subscale), anxiety and depression (Hospital Anxiety and Depression Scale~     (HADS)), and overall QoL (MQOL Total) in EG patients. Methodology: RCT pilot study with 60~     newly diagnosed ACP (stages III or IV) within 2 months of referral and 6 months of~     randomization, assigned randomly to: (1) EG, (2) AC, or (3) UC. Patients will complete~     self-report questionnaires (including outcome measures, as well as sociodemographic and~     medical variables) at 2, 4 and 6 months post-randomization.~   "
143119|NCT01693978|"~     The aim of this research is to assess whether Contingency Management is effective in~     improving treatment adherence in substance use disordered (SUD) patients with comorbid PTSD.~     Although Prolonged Exposure therapy (PE) is the gold standard treatment for PTSD, the few~     studies of this treatment in substance users have shown poor adherence. Contingency~     Management is a well-established approach that could be used to enhance adherence to PE. From~     a consented sample of 125 opioid-dependent and methadone-treated patients at Addiction~     Treatment Services, an intent-to-treat sample of 62 patients with co-occurring current PTSD~     will be offered PE. Half of the 62 participants will be randomly assigned to a Prolonged~     Exposure with Contingency Management (PE+CM) condition that provides monetary-based~     incentives for attending the PE therapy sessions. The comparison condition will be assigned~     to a Prolonged Exposure (PE) condition without the attendance incentives intervention. The PE~     sessions will be scheduled once per week for 12 weeks, with a 12-week follow-up. Groups will~     be compared primarily on adherence to the PE schedule, improvement in PTSD symptoms, and~     rates of drug use (urine specimens, self-reported use). The study's three primary aims are to~     1) Evaluate the efficacy of adding voucher-based attendance incentives to PE for PTSD to~     increase adherence in SUD patients in a methadone treatment program; 2) Evaluate the efficacy~     of adding voucher-based attendance incentives to PE for PTSD to reduce PTSD symptoms in SUD~     patients; and 3) Evaluate the effect of PE for PTSD on rates of drug use in SUD patients.~   "
143120|NCT01693965|"~     Bronchopulmonary infection is the most common and serious complication in the evolutionary~     course of cystic fibrosis (CF). Administration of antibiotics adapted to infecting pathogens~     is one of the key issues for its management. However, more than half of patients with CF have~     chronic respiratory infections for which infectious agent remains unknown leading to~     empirical antibiotic therapies that are not adapted to the causative agents. Recently, new~     technologies have been applied for the description and characterization of microbial agents~     in CF patients including molecular biology techniques that allowed us to detect and to~     identify new and/or emerging pathogens. Moreover, more sophisticated molecular techniques~     such as pyrosequencing and PCR amplification and cloning lead us to demonstrate the huge~     microbial diversity associated with chronic bronchopulmonary infections in this population.~     Otherwise, a metagenomic approach revealed the extraordinary complexity of the respiratory~     flora in these patients and, somewhat unexpected, abundance of anaerobes, viruses, and~     bacteriophages. In addition, it has been shown that some antibiotics commonly used in~     clinical practice for the treatment of respiratory infections were able to induce these~     bacteriophages, suggesting the existence of lateral gene transfer by transduction. The human~     microbiome is the set of microbial communities associated with the human body and represents~     all living microorganisms in the body. Its role in the immunity development has recently been~     demonstrated suggesting that changes in this ecosystem play a critical role in evolution of~     several human diseases. For example, in obesity it has been shown that there is a~     relationship between the intestinal human microbiota and nutritional and metabolic status of~     the hosts and specific alterations of these intestinal microbiota may represent a metagenomic~     signature of this disease. Evolution of the respiratory microbiota in patients with cystic~     fibrosis, whose nutritional status is often impaired (chronic malnutrition due to disorder of~     digestive absorption) and receiving regular antibiotic treatments remains unknown to date.~     Characterization of this ecosystem and its role is a critical step to understand the~     evolutionary course of the disease.~      The main objective of this seminal study is to describe and to characterize the respiratory~     microbiota from sputum samples obtained from a limited number of selected patients with CF~     from 5 regional care centers (CRCM) from South of France (Mucomed network) (2 patients per~     center : 6 adults and 4 children), with similar clinical, microbiological and functional~     status before and after a cure of antibiotics. Different microbiological tools will be used~     including axenic culture systems, co-culture on amoebae in order to to isolate and to~     identify the microbial communities. Identification of bacteria will be done using MALDI-TOF~     mass spectrometry and/or molecular techniques. Moreover, 16S rRNA PCR amplification followed~     by cloning and sequencing of PCR products from the same sputum sample will be carried out to~     identify and to compare the bacterial species identified using molecular methods. In a second~     step, once the respiratory microbiota was characterized, it will be interesting to develop a~     dedicated microarray that will allow to detect all the bacteria identified in the first stage~     of the project and to assess its relevance on a larger cohort of patients with CF by studying~     the correlation between the respiratory microbiota and clinical status of patients according~     to the prescribed antibiotic treatments.~      This study will open new clinical perspectives and will help us to determine the potential~     role of antibiotics on the microbiota evolution during treatment according to regional health~     care practices. This will contribute to better understand the role of the microbiota in the~     evolution of these chronic respiratory infections. It could be the first step for innovative~     therapeutic strategies, taking into account the balance of complex microbial flora and~     possibly evolving according to antibiotic therapies. It could also form part of a larger~     preventive strategy against transmission of specific pathogens in CF.~   "
143121|NCT01693952|"~     Treatment of cancer, and more particularly of haematological malignancies, partly relies on~     chemotherapy. Most therapeutic regimens display various toxicities, one of the most common~     being haematological toxicity, affecting the three lineages. While anaemia and thrombopenia~     can be overcome by haematological growth factors and transfusion, one of the most severe~     life-threatening toxicity is sepsis that develops during neutropenia. Neutropenia, despite~     the use of granulocyte colony-stimulating factors (G-CSF) and antibiotics, is still a major~     limitation in chemotherapy which is responsible for the majority of treatment-related~     morbidity and mortality and for prolonged hospitalisation.~      In neutropenic patients, sepsis is more frequent and more severe than in non-neutropenic~     patients. While the occurence of neutropenia and sepsis is often unpredictable and thus~     difficult to study in a prospective way, stem cell transplantation represents a quite~     convenient model to study such a question. Autologous stem cell transplantation indications~     in haematology are mainly multiple myeloma and relapsed lymphoma or Hodgkin disease. Briefly,~     after a mobilization procedure, a graft of patient's hematopoietic stem cells is collected by~     cytapheresis and frozen. When the patient has reached complete remission by conventional~     chemotherapy, he benefits from a very high dose myeloablative chemotherapy (called~     conditioning regimen). The conditioning regimen targeted to have high antitumoral~     activity leads to a cytokine storm resulting in a programmed inflammation. 36 hours after~     the lasting of the conditioning regimen, the CD34+ cells are thawed and infused to the~     patient. Thus neutropenia usually begins at D4 post transplantation and lasts for 10 days,~     until graft becomes functional. Thus, the timing and duration of neutropenia are very~     homogeneous. During neutropenia, fever and sepsis are very frequent (>80% patients), thus,~     most patient will be informative regarding sepsis, and there is an easy possibility of~     biological sampling before programmed inflammation (due to conditioning regimen), after~     inflammation before sepsis, then during and after the sepsis. Since the patient is~     hospitalized, the kinetic monitoring is quite easy~   "
143122|NCT01693939|"~     The purpose of this study is to document the programmed flap thickness to achieved flap~     thickness using the FS200 femtosecond laser in performing LASIK procedure. The FS200~     Femtosecond laser is a precision surgical device that is used to create a flap in a FDA~     approved LASIK procedure.~   "
143123|NCT01693926|"~     The objective of the study is to evaluate the impact of physical activity in obese and~     nonobese prepubertal children on:~        1. biological stress responses during a psychosocial stress test~        2. snacking and feeling of hunger in response to the same psychosocial stress test~        3. the moderating factor of attachment on the biological stress responses and on snacking~      Children will be investigated on one study day during 3.5 hours.~   "
143124|NCT01693913|"~     That a treatment using a cognitive-behavioral treatment for exercise and nutrition support~     will be associated with greater weight loss that a treatment of nutrition and exercise~     education.~   "
143125|NCT01693900|"~     Surgical trauma causes nerve sensitization leading to amplification and prolongation of~     postoperative pain. In experimental studies, pre-injury neural blockade using local~     anesthetics has been shown to reduce post-injury sensitization of the central nervous system,~     while similar techniques applied after the injury had less or no effect (FILOS).~     Investigators have therefore designed this study to examine the timing of FICB~     (pre-operatively versus intra-operatively) on postoperative pain in patients undergoing~     anterior hip replacement surgery.~   "
143126|NCT01693887|"~     The purpose of this study is to Comparison clinical efficiency with IPFI patients who treated~     by different protocols(empirical therapy or preemptive therapy) in ICU.~   "
143127|NCT01693874|"~     The investigators are developing and then testing whether Mindfulness-Based Stress Reduction,~     a group-based instruction for increasing mindfulness, reduces anxiety and depressive symptoms~     and improves cognitive functioning in older adults.~   "
143128|NCT01693861|"~     Observational, non randomized study aimed at measuring the effect of chemotherapy in the~     urinary concentrations of physiological modified nucleosides in 30 patients with metastatic~     colorectal cancer.~   "
143129|NCT01693848|"~     Observational, non randomized study aimed at measuring the effect of surgical resection of~     metastasis in the urinary concentrations of physiological modified nucleosides in 45 patients~     with metastatic colorectal cancer.~   "
143131|NCT01693822|"~     A-PREDICT is a study of axitinib in patients with metastatic renal cell carcinoma unsuitable~     for nephrectomy (as judged by the treating clinician) to evaluate efficacy, safety, toxicity~     and changes in biomarkers during therapy. Axitinib will given twice daily by mouth according~     to tolerability of treatment, for as long as patients are deriving clinical benefit. Blood~     and tumour tissue samples will be taken prior to and during therapy to evaluate biomarkers of~     treatment response. The primary clinical objective of this study is to define the activity of~     axitinib given to patients with metastatic renal cell carcinoma unsuitable for nephrectomy.~   "
143132|NCT01693809|"~     The principal aim of this study is to evaluate the presence of changes in cervical vestibular~     evoked myogenic potentials (VEMPc) after acute intake of caffeine in healthy subjects.~      Secondarily, it wants to standardize normal values exam VEMPc in otorhinolaryngology service~     of the hospital.~   "
143133|NCT01693796|"~     The purpose of this study is to determine the average risk for thyroid irradiation for any~     type of paediatric cardiac catheterization, based on the cummulative at-risk dose of 100 mSv,~     adjusted to the measured thyroid volume and to the patient's age.~   "
143134|NCT01693783|"~     This phase II trial studies how well ipilimumab works in treating patients with human~     papilloma virus (HPV)-related cervical cancer that has come back or that has spread to other~     areas of the body. Monoclonal antibodies, such as ipilimumab, can find tumor cells and help~     kill them or carry tumor-killing substances to them.~   "
143135|NCT01693770|"~     Magnetic Resonance guided Focused Ultrasound (MRgFUS) has demonstrated to be effective for~     pain control through thermally-induced cell death and periosteal denervation caused by~     cortical heating relative to acoustic energy absorption. There is also evidence that a high~     intensity focused ultrasound beam can penetrate through the cortical bone to the medullary~     space, producing thermal necrosis of cancer tissue. However, little is known about the~     potential effects of MRgFUS as first line therapeutic modality for pain palliation in~     skeletal metastases.~      Our hypothesis sought to assess the clinical performance of MRgFUS primary treatment of~     painful bone metastases and determine the potential of this technique for local tumor~     control.~   "
143136|NCT01693757|"~     The purpose of this study is to compare hop performance and jump landing strategy in soccer~     players with higher level sports activities after ACLR using either BPTB or STG and controls.~   "
143137|NCT01693744|"~     Background: Pseudoexfoliation (PEX) is characterised by the deposition of fibrillar material~     in an eye structures and many other parts of the body including kidneys and blood vessels. As~     both PEX and chronic kidney disease (CKD) are associated with oxidative stress and~     endothelial dysfunction we studied if the risk of PEX was increased in patients with CKD.~      Methods: Patients over age 40 with the diagnosis of CKD were included in the study. Chronic~     kidney disease was diagnosed as decreased glomerular filtration rate (GFR) of less than 60~     mL/min/1.73 m². Study groups were arranged as group 1 consisting of HD receiving patients,~     group 2 consisting of stage 1-4 CKD patients and group 3 consisting of patients with normal~     kidney functions (control group). Demographic properties and the rate of PEX were evaluated~     and compaired between the groups.~   "
143138|NCT01693731|"~     The purpose of this study is to determine how aromatase inhibitors (AIs) such as Arimidex,~     Aromasin or Femara affect a woman's oral health and oral health related quality of life.~     Patients, dental professionals and medical oncologists will benefit from a greater~     understanding of the best oral care follow up practices of breast cancer survivors using~     aromatase inhibitors.~   "
143139|NCT01693718|"~     The goal of the study is to test a particular combination of drugs and determine their~     ability to completely eliminate head and neck cancer.~   "
143140|NCT01693705|"~     To determine the morbidity and mortality of patients who have undergone percutaneous~     tracheostomy due to respiratory failure in the critical care unit and after intensive care in~     the internal medicine department, including follow-up of quality of life of these patients.~   "
143141|NCT01693692|"~     The purpose of this study study is to determine whether TD-9855 is effective in treating~     patients with fibromyalgia.~   "
143142|NCT01693679|"~     • To estimate renoprotective efficacy of Telbivudine treated patients with HBV-related liver~     cirrhosis.~   "
143143|NCT01693666|"~     Gaining too much weight in pregnancy is associated with adverse pregnancy complications and~     can have a long-term impact on maternal and offspring health, including increased risk for~     obesity and metabolic disease. Preventing excessive gestational weight gain could reduce~     adverse pregnancy outcomes and improve long-term health of mothers and offspring. Thirty~     obese (BMI ≥30) pregnant women will be recruited for this pilot study and randomly assigned~     to the Lifestyle Intervention ForEver (LIFE) program or routine care (RC). Participants will~     be enrolled before 18 weeks gestation and will be followed until 12 weeks after delivery.~     Women in the LIFE program will be given guidance on healthy eating and exercise at their~     regularly scheduled obstetric visits. To increase adherence to the program, a contingency~     management (CM) intervention offering incentives will be used to establish and maintain~     healthy nutrition and physical activity habits, working towards the goal of restricted weight~     gain (± 10lb) during their pregnancy. Three study testing visits will be scheduled for all~     participants: at study entry, 34-36 weeks gestation, and 12 weeks after delivering. Primary~     outcomes include adherence to the LIFE program, weight change in pregnancy and postpartum,~     and objective measures of maternal and offspring health.~   "
143144|NCT01693653|"~     This is a double-blind placebo controlled study targeting individuals with active Behcet's~     Syndrome who have oral ulcers and are resistant (have not responded after 4 weeks) to~     conventional treatments. Maximum allowable dose of colchicine (0.6mg twice a day) and stable~     dose for 4 weeks before enrollment. Prednisone or equivalent (< 10mg/day) permitted if dose~     stable for 6 weeks prior to enrollment.~      The study will investigate the safety of tocilizumab for this vasculitic condition in~     addition to its efficacy.~      The planned sample size is 30 participants per arm for a total of 60 participants. The study~     would be for 3 months, with a safety follow up at 2 months after study termination.~      Study participants will stay on their current treatments and either tocilizumab or placebo~     infusions will be given every 4 weeks in addition. Patients will be randomized to Actemra IV~     8mg/kg Q 4 weeks X 3 doses or placebo.~   "
143145|NCT01693640|"~     Hypothesis: Abatacept injections will decrease the number of oral ulcers seen in Behcet's~     patients~   "
143146|NCT01693627|"~     A randomised, comparative, prospective, single-blinded trial of two hip prosthesis:~        1. Marathon cemented all-poly acetabular cup(Depuy, Warsaw, Indiana), Corail uncemented~          femoral stem(Depuy, Warsaw, Indiana), 32mm Alumina Biolox Forte femoral head(Depuy,~          Warsaw, Indiana) and~        2. Pinnacle/Marathon uncemented cup(Depuy, Warsaw, Indiana), Corail uncemented femoral~          stem(Depuy, Warsaw, Indiana), 32mm Alumina Biolox Forte femoral head(Depuy, Warsaw,~          Indiana)~      There will be a further in-group randomisation to a Corail femoral stem with or without a~     collar, creating a number of 4 study-groups in total.~      The aims of the study are:~        -  To compare polyethylene wear and migration of the moderately cross-linked Marathon~          polyethylene in a cemented version(Marathon) and in an uncemented cup(Pinnacle/Marathon)~        -  To evaluate micromigration and periacetabular bone mineral density of the 2 cups using~          radiostereometry(RSA)~        -  To evaluate the migration patterns and proximal femoral bone density changes around the~          Corail stems with and without a collar~   "
143147|NCT01693614|"~     This is a phase II study evaluating the safety, tolerability and efficacy of BKM120 in~     patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), mantle cell~     lymphoma (MCL) or follicular lymphoma (FL).~   "
143148|NCT01693601|"~     This is a single-center, single arm, dose finding study to assess safety and tolerability of~     the oral combination of Panobinostat and Ruxolitinib in patients with myelofibrosis (MF) in~     chronic and accelerated phase.~   "
143149|NCT01693588|"~     High levels of postoperative pain are associated with an increased risk of lung and heart~     complications, are the most common reason for delayed discharge or for unexpected hospital~     admission after ambulatory surgery, and are responsible for prolonged recovery after~     inpatient surgery. Furthermore both neuropathic pain and post surgical pain inhibit weight~     gain and may have an impact on the patient's nutrition post operatively. The purpose of this~     study is to evaluate the effectiveness of a multimodality pain management protocol on~     postoperative neurosurgical pain.~   "
143150|NCT01693575|"~     The purpose of the study is to gather clinical data and safety information on the use of APX~     100 device for small-pupil cataract surgery and the management of intraoperative floppy iris~     syndrome (IFIS) during cataract surgery.~      The APX 100, a FDA-approved device (510K exempt), is a disposable stainless steal sterile~     device for mechanical expansion of pupillary diameter during intraocular surgery. The APX 100~     is inserted to the anterior chamber of the eye through standard clear corneal incisions. The~     device is then located on the pupil's border between the iris and the anterior lens capsule~     and the pupil's diameter is expanded.~      The APX 100 will be used in standard phacoemulsification cataract extraction surgery when~     small pupil diameter (<4.5 mm) is recognized preoperatively or develops intraoperatively due~     to IFIS.~   "
143151|NCT01693562|"~     This is a multicenter, open-label, first-time-in-human study with a standard 3+3~     dose-escalation phase in subjects with advanced solid tumors followed by an expansion phase~     in patients with advanced solid tumors. An exploration cohort has been added to determine the~     safety using Q4W dosing.~   "
143152|NCT01693549|"~     The purpose of this study is to determine whether cabazitaxel is effective in the treatment~     of metastatic breast cancer.~   "
143153|NCT01693536|"~     A randomised controlled trial to test if offering three visits to a dietician + two visits to~     a physiotherapist over six months + a home sphygmomanometer, will result in a reduction in~     sodium intake and an increase in fitness in people over 75yrs. Volunteers were enrolled from~     Oct 2008 to July 2009.~   "
143154|NCT01693523|"~     The goal of this clinical research study is to learn if minocycline can reduce the side~     effects of chemotherapy in patients with pancreatic cancer. In this study, minocycline will~     be compared to a placebo.~      Minocycline is an antibiotic that may help to reduce side effects of chemotherapy.~      A placebo is not a drug. It looks like the study drug, but it is not designed to treat any~     disease or illness. It is designed to be compared with a study drug to learn if the study~     drug has any real effect.~   "
143155|NCT01693510|"~     Weight gained during pregnancy is referred to as gestational weight gain (GWG). Excess GWG is~     a widespread problem that occurs in 55-75% of Canadian women who enter pregnancy overweight~     or obese (a group that represents over 50 % of all pregnant women) and about 40% women of~     normal weight. Excess GWG is associated with complications of pregnancy, such as post-partum~     weight retention, type 2 diabetes, elevated fats in the blood, and high blood pressure and~     may also lead to problems with the health of the newborn child. Our research aims to find~     ways to control GWG by developing new and practical approaches to diet and exercise targeted~     to overweight pregnant women that hold promise of improving their health both during~     pregnancy and thereafter. The experimental intervention is a diet of higher protein provided~     by dairy foods combined with an exercise program modified to the abilities of overweight~     pregnant women; and the control is the usual advice given by their primary care providers,~     information on healthy pregnancy from Health Canada, and a focus group session exploring~     women's experiences with exercise, nutrition, and gestational weight gain. The results of~     this study will allow us to design future large clinical studies in all pregnant women to~     help control the weight gain in all pregnant women.~   "
143156|NCT01693497|"~     This study aims to compare two active psychological treatments for PTSD. One is an~     established therapy, Cognitive Processing Therapy (CPT) which operates as a control condition~     for a newly developed intervention, an integrative Gestalt-based trauma therapy, Dialogical~     Exposure Therapy (DET). There is no inactive control condition. We expect the two therapies~     to perform on a similar level, which would constitute evidence for the efficacy of DET.~   "
143171|NCT01693302|"~     Blood glucose levels in patients with type 1 diabetes tend to peak after eating a meal due to~     the delayed action of insulin when compared to carbohydrate absorption from food. It is the~     hypothesis of the investigator that administering the insulin for a meal 20 minutes before~     the meal will result in lower blood glucose peaks compared to administration of insulin~     immediately before or 20 minutes after starting to eat.~      All subjects will eat the same meal on three different occasions. Insulin will be~     administered at one of the three times at each visit.~   "
143172|NCT01693289|"~     the study compare the hormonal-metabolic and reproductive outcome between combined~     metformin-letrozole and ovarian drilling in clomiphene resistant women with polycystic~     syndrome~   "
143157|NCT01693484|"~     Researchers in the Orthopaedic surgery department at LSU Medical Center-Shreveport hope to~     learn if patterns of blood-flow around the incision site of patients undergoing surgery for~     heel-bone fractures can help predict whether complications will arise after a specific type~     of operation.The goals of this research study are to effectively answer as many of the~     following research questions as possible:~        1. Can a drug normally used to evaluate adequate blood flow in plastic surgery and tissue~          transfer be used to identify altered patterns of blood flow at the operative site of~          Calcaneus fractures, when compared to the uninjured extremity?~        2. Are changes in blood flow identifiable at the operative site post operatively?~        3. Are there certain patterns of blood flow present preoperatively or postoperatively that~          can predict wound complication?~        4. Can certain patterns of blood flow predict the location of slough or dehiscence after~          surgery?~        5. Does the incision site and its proximity to specific patterns of blood flow possibly~          predict wound complication?~      The hypothesis is that the study drug will show a correlation between certain patterns of~     blood flow and whatever post-operative complications may arise.~   "
143158|NCT01693471|"~     The objectives of this study are to investigate the influence on HR-QOL (SF-36 v2) resulting~     from the compliance of MUCODYNE Tablets or MUCODYNE DS (Dry Syrup) 50% in asthma patients~     whose control levels are partly controlled or uncontrolled.~   "
143159|NCT01693458|"~     The Appreciative Inquiry Change Agents (CA) program (NAMWEZA) intends to address broad~     societal issues by engaging HIV-positive leaders as 'change agents' in their communities. In~     this study, the CAs will be recruited from an HIV Care and Treatment Centre in Dar es Salaam.~     The Namweza program has the potential to address structural issues related to HIV risk, such~     as access to limited resources, through an entrepreneurial component of the program. A~     positive, or appreciative, focus promotes CAs to examine assets in themselves and in their~     networks, encourages strengthening of relationships, and facilitates planning for a positive~     future for themselves, their families, and their communities.~      A stepped wedge randomized trial will be performed to evaluate the effectiveness of the~     program for the following primary outcomes: uptake of HIV services among network members of~     the CAs; rate of unprotected sex and frequency of concurrent relationships among CAs and~     their social networks; and levels of self-esteem, general self efficacy, and risk of intimate~     partner violence in the CAs. Secondary outcomes include: depressive symptoms, hopefulness,~     and HIV-related stigma (among CAs); social support and quality of relationships (among CAs);~     and HIV knowledge, attitudes and self-efficacy in preventing HIV transmission or re-infection~     (CAs and their networks).~      The following are primary hypotheses that will be tested through this stepped wedge~     randomized trial evaluation:~        1. Uptake of HIV services will increase among individuals in the network of the~          HIV-positive Change Agents related to the intervention;~        2. Levels of self-esteem and general self-efficacy will increase in trained Change Agents;~        3. Rate of unprotected sex and number of concurrent partners will decrease (among network~          of Change Agents as well as Change Agents themselves; i.e. the 'study population'); and~        4. Prevalence of intimate partner violence (IPV) will decrease in Change Agents.~           Secondary hypotheses are:~        5. Prevalence of depressive symptoms and HIV-related stigma will decrease and level of~          hopefulness will increase in trained Change Agents;~        6. Levels of HIV knowledge, attitudes and self-efficacy in preventing HIV transmission and~          re-infection among CA and their networks will increase; and~        7. Degree of social support and quality of relationships will improve among CA.~      If the proposed intervention is found to be effective, linkages with the Tanzanian Ministry~     of Health and other stakeholders will enable scale-up of the program throughout the country.~   "
143160|NCT01693445|"~     This study will attempt to determine the feasibility of combination of Oxaliplatin,~     Irinotecan, and S-1, the maximum tolerated dose and the recommended doses of the agents used,~     and to preliminarily evaluate the antitumor activity in untreated patients with advanced~     gastrointestinal cancer.~   "
143161|NCT01693432|"~     This study will evaluate the efficacy of docetaxel and S-1 combination chemotherapy in Korean~     patients with esophageal cancer.~   "
143162|NCT01693419|"~     This study will conduct a phase II study of gemcitabine, erlotinib, and S-1 as first-line~     chemotherapy in patients with advanced pancreatic cancer and evaluate the EGFR expression,~     KRAS mutation, and BRAF mutation as predictive or prognostic markers~   "
143163|NCT01693406|"~     Childhood obesity is a critical global public health concern. Breastfeeding is the ideal~     choice for infant nutrition. However, rapid and excess weight gain during infancy predicts~     later, even among breastfed infants. This risk is higher if mothers are obese and/or~     diabetic. Composition of bioactive components of breast milk may differ based between mothers~     who are normal weight (NW), overweight, or who have diabetes. Obesity and Type 2 Diabetes are~     associated with overall increases in inflammation and oxidative stress, but how breast milk~     composition is affected remains unknown. The investigators overarching goal is to determine~     how maternal obesity and Type 2 Diabetes impacts human breast milk composition and how~     differences in composition may impact infant growth and fat development. The investigators~     are undertaking a study that follows 20 Normal Weight, 20 Obese, 20 Gestational Diabetic, and~     20 Type 2 Diabetic mothers and their infants over the first 4 months of life. The~     investigators will track infant weight and fat gain and monitor maternal glucose control. The~     investigators will also collect breast milk samples over the first 4 months and measure~     concentrations of growth and appetite hormones, cytokines, markers of oxidative stress and~     nutrient composition in milk. The investigators predict that concentrations of~     growth-regulatory hormones (insulin and leptin) in addition to the inflammatory cytokines and~     markers of oxidative stress will be lowest in breast milk from NW mothers, higher in breast~     milk from obese and gestational diabetic mothers, and highest in Type 2 Diabetic mothers'~     breast milk. The investigators expect these differences will be most pronounced in the first~     2 weeks after birth. The investigators also predict that breast milk concentrations of these~     biomarkers will be associated with infant fat gain. What the investigators find will help~     understand how early infant nutrition and growth may affect that child's later risk of~     obesity.~   "
143164|NCT01693393|"~     Sandimmun optoral (Cyclosporin A) is used for the musculoskeletal manifestations of Primary~     Sjögren Syndrome~   "
143165|NCT01693380|"~     Vaccinating schoolchildren against influenza would prevent the disease among non-vaccinated~     household members.~   "
143166|NCT01693367|"~     The purpose of this study is to evaluate the performance of Dynamic Locking Screws (DLS) used~     to stabilize the shaft component of distal femur fractures in comparison to standard locking~     screws (SLS). The hypothesis is that DLS will lead to better functional outcomes (WOMAC~     score) due to increased and more symmetrical callus formation and fewer non-unions.~   "
143167|NCT01693354|"~     The purpose of this study is to determine whether mid-dilution hemodiafiltration is effective~     in the reduction of the crude mortality risk in patients who have been undergoing renal~     replacement treatment for less than 1 year. Patients will be randomized since the beginning~     of the study in two groups: standard HF dialysis and mid-dilution HDF.~   "
143168|NCT01693341|"~     To examine the feasibility of improving stroke patients' physical functional recovery and~     social participation through improving caregiver's care capability.~   "
143169|NCT01693328|"~     National multicenter, prospective, observational study in cancer patients with chronic~     background pain and breakthrough pain to whom PecFent® has been prescribed under pragmatic~     condition by a specialist in the treatment of cancer pain conditions.~      • Study objectives include assessment of early treatment satisfaction.~   "
143170|NCT01693315|"~     The objective of this dose-escalation study is to evaluate the safety, tolerability and~     efficacy of AMA0076 in reduction of intraocular pressure in subjects with ocular hypertension~     or primary open-angle glaucoma.~   "
143173|NCT01693276|"~     This study will analyze the effects, good and/or bad, of the drug Abraxane in combination~     with gemcitabine and gemcitabine with concurrent radiation therapy for patients with locally~     advanced pancreatic cancer that cannot be removed by surgery. All of the medications used in~     this study are FDA-approved for use in patients with pancreatic cancer.~   "
143174|NCT01693263|"~     Dialysis access, which is the connection that allows blood to flow in and out of the body~     during dialysis sessions, is important to remove wastes and excess fluid for patients with~     end stage renal disease (ESRD). One method used to access the vein and artery for dialysis is~     called a brachiocephalic fistula. Patients are being asked to participate in this study~     because they have endstage renal disease, and their doctor has recommended that they will~     have brachiocephalic fistula placed for their dialysis access.~      A common problem seen in patients with a brachiocephalic fistula (BCF) is cephalic arch~     stenosis (CAS). CAS is a narrowing in the central vein (located in the upper chest). CAS~     causes problems with the opening of the veins and arteries needed for dialysis. Once someone~     suffers CAS they may need several radiology procedures as well as surgery to help correct the~     problem.~      The BCF may fail once CAS develops.~      The purpose of the research study is to gather information about the BCF and what is~     happening inside the vein. The researchers hope to find out what may be the cause of CAS.~   "
143175|NCT01693250|"~     The emerging epidemic of type 2 diabetes mellitus (T2DM) in children is coupled with the~     increased prevalence of childhood obesity in the last two decades. Obesity during the~     adolescent years is associated with many adverse health consequences, including T2DM,~     hyperlipidemia, and psychosocial problems. The first step toward effective obesity management~     and T2DM prevention is monitoring of physical activity (PA) and dietary intake. With the~     rapid expansion of cellular networks, and advancements in smartphone technologies, it is now~     possible to monitor PA and dietary intake and at the same time to transmit data digitally to~     their primary care providers (PCP). The proposed pilot study will include the collaboration~     among UCSF, North East Medical Services (NEMS), mHealth teams, and overweight and/or obese~     adolescents. The study will adapt and implement smartphone-based technologies and integrate~     these technologies with the Electronic Health Record (EHR) to increase PA and dietary intake.~     Two specific aims of this proposed study include: (1) adapt fitbit Ultra applications for the~     smartphone-based technologies and EHR and (2) and assess the feasibility and estimate the~     effect for patient outcomes (self-efficacy, physical activity, dietary intake, BMI, and lipid~     profile), at 3 months post intervention between the intervention and control groups. The~     smartphone app for the intervention group will allow the teens to graphically compare daily~     PA and dietary intake with the goal, participate in a reward program where they can collect~     virtual points for achieving the goal, and play interactive games related to PA and diet. A~     total of 40 overweight and/or obese adolescents at NEMS will be recruited and randomized to~     the feasibility study (Aim 2). Findings from this study will be used to plan for a NIH R01.~   "
143176|NCT01693237|"~     The current trial aims to investigate the impact of continuous feedback on dropout and~     outcome in group therapy. The hypothesis is that continuous feedback to patient and therapist~     on treatment progress and alliance will 1) increase adherence and 2) increase treatment~     outcome.~   "
143177|NCT01693224|"~     The purpose of this study is to evaluate the accuracy, diagnostic yield, operational~     performance, and time to diagnosis of a novel lateral-flow urine LAM test in detecting~     tuberculosis in HIV-infected adults.~      A secondary study objective is to evaluate the accuracy and diagnostic yield of the Cepheid~     Xpert MTB/Rif test in detecting tuberculosis in the blood of HIV-infected adults.~   "
143178|NCT01693211|"~     This is a prospective, randomized study evaluating the circularity of the anterior~     capsulotomy performed by the VICTUS femtosecond work station (Group A) versus the manual~     capsulotomy (Group B) of a minimum of 22 eyes and maximum of 30 eyes per group diagnosed with~     cataract, scheduled to undergo removal by phacoemulsification with intraocular lens~     implantation in SNEC.~      The primary study end point is to determine if the circularity of the created rhexis is~     better in Group A as compared to Group B.~      The secondary study end point is to determine the diameter of rhexis is more precise and~     reproducible in Group A as compared to Group B.~   "
143179|NCT01693198|"~     People swimming or surfing in lake Kineret , sometimes complain of nasal stuffiness ,~     sneezing and itching .Typically, it happens during or immediately after contact with the~     lake`s water . The symptoms are compatible with immediate allergic reaction. Previous reports~     suggested a connection between similar symptoms and contact with different cyanobacteria~     (living in fresh water lakes). In this study we intend to prove the mechanism of these~     reactions. To prove the exact allergen that causes allergic rhinitis allergists perform skin~     tests with different suspected allergens. Likewise, we would like to perform skin tests to~     different proteins extracted from cyanobacteria collected in lake Kineret.~   "
143180|NCT01693185|"~     The aim of the present study is to compare patient's recovery times after elective~     colonoscopy employing remifentanil only vs conventional combination of midazolam and~     meperidine~   "
143181|NCT01693172|"~     The aim of this study is to evaluate the effect of an early postoperative physical~     rehabilitation program on the functional capacity and incidence of postoperative~     complications in patients undergoing major elective surgery for treatment of a neoplasm~   "
143182|NCT01693159|"~     The SUPPORT trial is an open-label, prospective, randomized, national multicenter~     intervention study to evaluate the effectiveness of ethyl-2-cyanoacrylate versus the standard~     treatment of each institution on the pain intensity and QoL in patients with locally advanced~     head and neck cancer suffering from painful cetuximab-induced rhagades during~     radioimmunotherapy.~   "
143183|NCT01693146|"~     Evaluation of Safety and Efficacy of Short time TNI Treatment in Patients with COPD and~     hypercapnia.~      Acute testing of oxygen demand using TNI vs. standard oxygen application in stable COPD~     patients with hypercapnia.~   "
143184|NCT01693133|"~     The objective of this study is to evaluate the percentage of patients with complete diabetic~     foot ulcer (DFU) closure following up to 12 weeks of treatment with either dehydrated human~     amnion/chorion membrane (dHACM) plus standard of care (SOC) or SOC alone.~   "
143185|NCT01693120|"~     VICTORY AF is an IDE, prospective global, multi-center, single arm, controlled, unblinded,~     investigational clinical study. The purpose of this clinical study is to evaluate the risk of~     procedure and/or device related strokes in subjects with persistent or long-standing~     persistent atrial fibrillation (AF) undergoing ablation with the Phased RF System.~   "
143200|NCT01692912|"~     Canadian Rheumatologists will be randomized to treat their participants with active Psoriatic~     Arthritis to a target (disease activity score <2.6), or as per their routine care. The aim of~     this study is to determine whether treating to a target results in greater disease~     improvement than treating patients using routine care.~   "
143186|NCT01693107|"~     This study will be divided into two phases. The purpose of the Phase I registry is to assess~     the current force being used for ablation of symptomatic paroxysmal AF in a wide range of~     operators in different Canadian centres with the operators being blinded to the contact force~     data.~      In Phase II of the study, operators will have open use of the force contact data. Phase I and~     II data will be compared in order to assess the efficiency of using the THERMOCOOL®~     SMARTTOUCH™ catheter.~   "
143187|NCT01693094|"~     The investigators plan a prospective randomized controlled study that compares the treatment~     decisions made by patients who receive decision aids, as compared to patients treated with~     usual care and the American Society for Surgery of the Hand brochures. The investigators~     expect to enroll 126 patients.~   "
143188|NCT01693081|"~     'Off periods' where people with Parkinson's disease are slow, stiff and unable to function~     are disabling, and a treatment which can converts people to a on, good, able to function~     state would be extremely useful. We assessed safety, tolerability and efficacy of inhaled dry~     powder apomorphine (VR040) in a clinic-based study in this setting.~   "
143189|NCT01693068|"~     This is a Phase 2, multicenter, randomized, controlled, open-label trial of pimasertib versus~     dacarbazine aimed to confirm the activity of pimasertib in previously untreated subjects with~     N-Ras mutated locally advanced or metastatic malignant cutaneous melanoma by comparing the~     progression-free survival (PFS) of subjects treated with either pimasertib or dacarbazine and~     by getting a better understanding of the efficacy, safety, pharmacogenomics (PGx) and their~     relationship with pimasertib exposure.~   "
143190|NCT01693055|"~     Study title~        -  Safety and Efficacy Evaluation of UltheraTM in Treatment of Baggy Eyelid Study design~        -  single arm and Investigator Initiative pilot study~   "
143191|NCT01693042|"~     Single or repeated application of autologous bone marrow-derived stem cells to treat chronic~     post-infarction heart failure~   "
143192|NCT01693029|"~     The purpose of this study is to show biosimilarity of HX575 epoetin alfa with the US licensed~     reference product Epogen®/Procrit® when applied subcutaneously. This study is intended to~     generate data supporting that the efficacy and safety under treatment with HX575 and~     Epogen®/Procrit® are comparable.~   "
143193|NCT01693016|"~     The purpose of this study is to evaluate the value of the new technique of non-invasive~     measurement of Hb in children undergoing a surgical procedure.~   "
143194|NCT01693003|"~     Exercise intolerance is a major complain of patients with chronic obstructive pulmonary~     disease (COPD). Dynamic hyperinflation has been recognized as an important limiting factor~     responsible for the appearance of intolerable dyspnea during exercise. Regular treatment with~     long-acting bronchodilators promotes a more sustained reduction of hyperinflation and~     consequent symptom relief and increase in the patient's ability to overcome physical demands~     of daily life. Tiotropium bromide (TIO) is a new generation, long-acting anticholinergic~     bronchodilator that significantly improves lung function, reduces symptoms and improves~     exercise tolerance in patients with advanced COPD. Indacaterol is a new ultra-long duration~     (>24 h) β2-agonist, which promotes sustained dilation of the bronchi with a once-daily~     administration. Compared to tiotropium, indacaterol provides evidence that is as effective as~     tiotropium for bronchodilation, as well as other clinical outcomes such as dyspnea and state~     of health. However, comparative effects of indacaterol versus tiotropium with regard to~     outcomes in tolerance, dyspnea and dynamic lung hyperinflation during exercise is scarce. We~     hypothesized that indacaterol and TIO are not different in terms of exercise tolerance and~     its determinants (dynamic hyperinflation and dyspnea).~   "
143195|NCT01692990|"~     20 normal-weight healthy subjects (10 males, 10 females) were in two periods given 10 of~     0.5-mL capsules/day of fish oil and soybean oil for 3 weeks. In the end of each period they~     were given a standard breakfast and asked to report their appetite on visual analogue scales~     (VAS) immediately before and after the meal. The results were analyzed in accordance with the~     paired design under consideration of both supplement sequence and gender.~   "
143196|NCT01692977|"~     The disruption of spatial orientation is considered the second most common cognitive symptom~     of dementia, affecting nearly all activities of daily living. Research in the field of~     environmental psychology has helped to highlight the influence of the environment on patients~     with Alzheimer's disease or related syndromes. With regard to spatial orientation, it has~     been shown that an environment can provide support for cognitive failures in subjects if that~     particular space is adapted. While numerous studies have focused on the architectural~     environment (hospital, housing facility), none have explored the ability of patients to~     orient themselves in a natural environment such as a garden. Yet, in recent years, such~     gardens, known as healing gardens, have emerged in housing and care facilities, providing~     genuine support for the care management of patients with Alzheimer-type dementia. Various~     works have been published outlining recommendations for their management. However, with~     regard to spatial orientation, none of the available research has explored the basic~     principles on which to rely on in order to organize the elements of outdoor spaces into~     itineraries that promote orientation, according to ZEISEL and TYSON (1999). In the absence of~     such data, these authors recommend relying on five elements, identified by Lynch in his~     landmark book Image of the City (1960), that people use to orient themselves and find their~     way. These are  paths ,  edges ,  districts ,  nodes  and  landmarks . The~     hypothesis to verify is that patients with Alzheimer's disease do not rely on the same~     elements of the garden as non-Alzheimer's subjects in making orientation decisions and to~     mentally picture this environment.~   "
143197|NCT01692951|"~     This study aims to evaluate the performance of serum free fatty acids as biomarkers for the~     identification of lung cancer.~   "
143198|NCT01692938|"~     To conduct a precision study to assess the microperimetry function of the Spectral OCT/SLO.~     The study will assess variability across measurements taken by three different~     operator-device configuration across clinical sites, variability between subjects within a~     given operator-device configuration, and variability within a subject for a single~     operator-device configuration.~   "
143199|NCT01692925|"~     This trial is conducted in Europe. The aim of the trial is to investigate the~     pharmacokinetics (the exposure of the trial drug in the body) of four lots of turoctocog alfa~     (a human recombinant coagulation factor VIII (FVIII)) in subjects with haemophilia A.~   "
143203|NCT01692873|"~     Pancreatic cancer is among the most serious human neoplasia and the most difficult to treat.~      Most patients present at diagnosis a non resectable, locally advanced or metastatic disease,~     with a median survival of 12 month.~      The aim of this study is the identification of diagnosis biomarkers, predictive of the~     therapeutic response.~      This project investigate the use of molecular analyses applied to pancreatic tumor cells~     collected by microbiopsy under ultrasound-endoscopy, and blood cells.~   "
143204|NCT01692860|"~     . The purpose of this study is to examine the effects of eating a larger amount of~     dairy-based protein on risk factors for metabolic syndrome~   "
143205|NCT01692847|"~     A hospitals manual method of patient monitoring will be implemented in an automated system~     and supported by an early patient deterioration detection for timely escalation. The purpose~     of this study is to assess if clinical outcomes of patients in Acute Care are significantly~     improved by such a system.~   "
143206|NCT01692834|"~     To compare the bioavailability, pharmacokinetic profiles and the tolerability of two~     formulations of intravenous cyclosporine in healthy volunteers.~   "
143207|NCT01692821|"~     Adequate perfusion and oxygenation is essential for the function of the inner retina.~     Although it is known that oxygen tension is very well autoregulated in the retina, the~     physiological mechanisms behind this regulation process are not fully explored. The~     development of new instruments for the non-invasive measurement of oxygen tension in retinal~     vessels now allows for the more precise investigation of these physiological processes. The~     current study seeks to evaluate the retinal oxygen saturation in healthy subjects while~     breathing different oxygen mixtures to achieve a hypoxic and a hyperoxic state.~   "
143208|NCT01692808|"~     The purpose of this study is to determine if high doses of vitamin D3 administered orally as~     adjunct therapy to children with Crohn's disease could improve the outcome of the disease.~   "
143209|NCT01692795|"~     Large randomised trials have shown that cardiovascular medications prescribed to patients at~     high cardiovascular risk are effective in reducing the incidence of cardiovascular events.~     Their use is recommended in the United Kingdom and international guidelines (e.g. the~     National Institute of Clinical Excellence). However, these medications do not prevent~     cardiovascular events in all patients and there is now a body of research investigating the~     effects of cardiovascular medications on outcomes in myocardial infarction (MI), including~     clinical presentation, infarct size and post-MI mortality. However, the independent effects~     of cardiovascular drugs on post-MI all cause mortality are unclear, and there are limitations~     to many of the published studies in terms of their cardiovascular drug exposure data. This~     project utilizes prospectively collected data on cardiovascular drug use, and links to MI~     data from hospital and mortality records.~   "
143210|NCT01692782|"~     A Phase 2 study of SEP-225289 in adults with attention deficit hyperactivity disorder (ADHD).~   "
143211|NCT01692769|"~     Background: Trauma is a major cause of death in children and teenagers. When young patients~     have suffered major traumatic injuries, they require intravenous (iv) fluids to keep their~     blood vessels full and ensure blood flow to vital organs. Current fluid guidelines by~     International Trauma Committees recommend either Normal Saline (NS) or Ringer's Lactate (RL)~     as the fluid of choice for these patients. Although these solutions share some similarities~     in their composition, there are also some significant differences in sodium, chloride and~     lactate concentrations. Despite these differences in fluid composition, there has never been~     a study comparing these two fluids in paediatric trauma patients to determine which is~     optimal. In this study, the investigators aim to determine the optimal fluid choice for~     trauma resuscitation of young patients.~      Hypothesis: The investigators hypothesize that severely injured paediatric trauma patients~     resuscitated with NS will have optimal blood sodium levels compared to patients resuscitated~     with RL.~      Methods: The investigators will study 50 paediatric trauma patients that will be randomized~     so that half will randomly receive NS and half will receive RL as their only iv fluid for 24~     hours. After 24 hours, the investigators will compare in blood the sodium level, the amount~     of acid, and the concentrations of inflammation molecules in relation to those whom received~     NS versus RL.~      Expected Results and Significance: Maintaining optimal levels of these biochemical markers is~     imperative in reducing morbidity and mortality in severely injured paediatric patients. If~     significant differences are present, the investigators will be able to determine which fluid~     is preferred and expect these data to complement current trauma resuscitation guidelines.~   "
143212|NCT01692756|"~     This research study is the first of its kind and will allow health care professionals and~     researchers to answer many questions about the reasons why anterior cruciate ligament (ACL)~     injury leads to knee pain and disability and osteoarthritis. We also hope that this study~     will be the beginning of new, more powerful and safer drugs to help patients with ACL~     injuries heal sooner and return to sports or daily activities pain free. Study participants~     will be recruited from the University of Kentucky and Vanderbilt University.~      The purpose of this research is to gather information on how safe and effective Kenalog® is~     in alleviating knee pain following ACL rupture.~   "
143213|NCT01692743|"~     Improved methods are needed to monitor patients with inflammatory bowel disease. Telemedicine~     has shown promise in patients with other chronic diseases; pilot testing in our patients with~     inflammatory bowel disease demonstrated that the technology was feasible and improved~     clinical outcomes.~      The telemedicine system for patients with inflammatory bowel disease (Tele-IBD) should~     improve outcomes for patients, improve access to care in areas with limited resources, and~     decrease health care costs.~   "
143234|NCT01692470|"~     The purpose of this study is to assess the safety and effectiveness of rilpivirine~     hydrochloride in combination with other anti-retroviral (ARV) medications for the treatment~     of ARV-naive (patients who have not been exposed to ARV) Filipino patients with human~     immunodeficiency virus type 1 (HIV-1) infection.~   "
143235|NCT01692457|"~     The purpose of this study is to assess the safety and effectiveness of golimumab for the~     treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis among~     Filipino patients.~   "
143247|NCT01692301|"~     The study examined the efficacy of LCZ696 in comparison to the ARB olmesartan on Central~     Aortic Systolic Blood Pressure (CASP) and other measures of central hemodynamics and arterial~     stiffness in elderly patients with an elevated systolic blood pressure (SBP) and widened~     pulse pressure (PP).~   "
143214|NCT01692730|"~     This trial will test the effectiveness of an enhanced web-based smoking cessation~     intervention for student smokers at 2-year Community Colleges. Young adults continue to be~     understudied, so more studies of cessation interventions are needed to generate an acceptable~     level of strength of evidence regarding quit rates, particularly so for Community College~     students for whom little data on cessation are available. Students (research subjects) will~     be directed to one of two intervention websites with various levels of novel interactive and~     social network features, including a variety of better-practice features recommended by~     recent literature, and technologically advanced proactive features (e-mails, SMS texting, and~     social networking).~      Our study hypothesizes that students with access to an enhanced website will have higher~     rates of self-reported intention to quit, a higher number of quit attempts at 6-months~     compared to those in in a non-enhanced website. Overall, this study will evaluate evidence~     for a novel enhanced cessation intervention model and will add to our understanding of~     successful intervention with an understudied population of primarily young adult Community~     College smokers. The intervention components will be replicable and, if effective, the~     methodology is applicable across populations, and has the potential for broad public health~     impact through improved delivery of effective stop smoking interventions via the internet.~   "
143215|NCT01692717|"~     The objective of this clinical study, randomized, crossover is to evaluate the~     pharmacokinetic profile of the polypill (atorvastatin + lorsatana + hydrochlorothiazide)~     Laboratory Hypermarcas S / A, in relation to drugs Citalor ® (atovastatina - Pfizer) and~     Hyzaar ® (losartan + hydrochlorothiazide - Merck Sharp & Dohme) by comparing the serum~     concentration of analytes unchanged (AT, LS and HCTZ) in healthy subjects.~   "
143216|NCT01692704|"~     An open label, prospective, non-randomized single arm study. Combination of two treatment~     modalities - HAI with FUDR and systemic chemotherapy with cisplatin and gemcitabine.~      Definition of the maximum tolerated dose (MTD) of intravenous gemcitabine in combination with~     intravenous cisplatin and intra-arterial FUDR. Definition of safety and toxicity of this~     combined regional and systemic treatment approach. Definition of the response rate after 3~     months of hepatic intra-arterial chemotherapy with continuous infusion FUDR with or without~     ligation of the right or left portal vein, in combination with 3 months of systemic cisplatin~     and gemcitabine in patients with unresectable intrahepatic or hilar CCC.~      A total of 9-18 patients are required. 3-6 patients per dose level. A maximum of three dose~     levels (1 - 3) has been defined.~      Statistical Methodology: Traditional 3+3 dosing algorithm to find MTD.~        -  Trial with medicinal product~   "
143217|NCT01692691|"~     The purpose of this study is to determine whether dacarbazine and carmustine at the doses and~     schedule used in this study will help to increase tumor shrinkage.~   "
143218|NCT01692678|"~     The purpose of this study is to find the optimal dose of trabectedin for Chinese patients~     with locally advanced or metastatic L-sarcoma (liposarcoma or leiomyosarcoma) who were~     previously treated (in any order) with at least an anthracycline and ifosfamide containing~     regimen, or an anthracycline containing regimen and 1 additional cytotoxic chemotherapy~     regimen (Part 1) and to evaluate whether the overall survival (OS) of the trabectedin group~     is superior to dacarbazine group (Part 2).~   "
143219|NCT01692665|"~     Ocular aberration may play a role in determining optical quality. Recently performed study~     reported that ocular aberration of preocular tear film would be important factor in not only~     diagnosing the dry eye but also determining the efficacy of treatment. Therefore, in this~     study, the investigators will aim to prove the improvement of quality of vision via ocular~     aberration changes indirectly after the proper treatment for moderate and severe meibomian~     gland dysfunction. Also, the investigators will evaluate the changes of keratometric values~     after treatment for moderate and severe meibomian gland dysfunction, which could be~     demonstrated by autokeratometry, IOLMaster, Pentacam, and iTrace.~   "
143220|NCT01692652|"~     Meibum lipids are modified in patients with MGD, resulting in tear instability, evaporative~     dry eye, and eyelid inflammation. These changes add to corneal damages and exacerbate ocular~     symptoms, which are all associated with the constant release of inflammatory mediators. To~     our knowledge, there has been no study on tear cytokine levels in MGD patients treated with~     topical loteprednol etabonate. The investigators, thus, evaluated both inflammatory tear~     cytokine levels and corresponding clinical outcomes for analyzing the efficacy of topical~     loteprednol etabonate in moderate and severe MGD. The aim of this research was to determine~     the concentration of inflammatory tear cytokines in patients with MGD and to compare the~     changes in tear cytokine levels between topical loteprednol etabonate and warm compress~     treatment group and warm compress only treatment group.~   "
143221|NCT01692639|"~     Acetaminophen is the first drug involved in voluntary drug poisoning. According to the~     studies conducted in the USA and in the United Kingdom, it is the first cause of acute liver~     failure, and this poisoning is responsible of 10 percent of liver transplants each year in~     these countries. Mortality is about 1/3 at the stage of acute liver failure. The main risk~     factors are malnutrition and chronic alcoholism. Ease of access to this toxic and highly~     correlated with factors predisposing socio-economic field are an important issue, including~     the speed and appropriateness of care are key factors both in terms of reducing morbidity~     mortality in socio-economic terms for the community.A nomogram defines a statistical~     threshold from which the blood concentration of paracetamol has a significant risk of liver~     toxicity. The blood paracetamol dosage practiced today at the 4th hour after ingestion of a~     toxic dose, but there is no consensus on whether or not to repeat this dosage during the~     treatment, as the first result is beyond the threshold or not.The administration of the~     antidote NAC (N-acetyl-cysteine) in proven cases of liver toxicity is also regulated by a~     protocol that can vary in different services.In the absence of clear guidelines, the question~     of the need for iterative dosages of paracetamol blood beyond the fourth hour post-ingestion~     if the initial paracetamol blood measurement is below the curve nomogram remains open.Is it~     possible to limit blood tests to a single assay paracétamolémie to H4 when it is below the~     curve, and thus enable the return home of the patient's somatic point of view (excluding~     psychiatric care when is voluntary drug intoxication), with consequences in terms of costs~     (hospital days) and duration of treatment?~   "
143246|NCT01692314|"~     The purpose of this study is to investigate the effect os resistance training on~     microvascular reactivity, endothelial functions, inflammatory markers, blood pressure, heart~     rate, body composition and physical fitness in obese adolescents.~   "
143222|NCT01692626|"~     When cancer patients are treated with the drug cetuximab they very often develop a rash.~     Usually it appears on their face and back and other parts of the body. The rash looks like~     acne and is treated with skin creams or antibiotics most of the time. The rash can become~     very painful and cause patients to stop using cetuximab to treat their cancer, even if~     cetuximab was helping fight their cancer.~      Cetuximab is known to be a good drug to help treat cancer. This study will help us learn~     about the rash cetuximab causes so hopefully future patients can finish taking cetuximab for~     their cancer. In this study the investigators will use a cream called pimecrolimus (Elidel)~     to see if it will help prevent the rash or keep the rash from getting worse. The~     investigators also want to see how the rash affects patients and their quality of life.~      Participants will be in this study for about four weeks if their rash does not get worse.~     They will need to apply the study cream and placebo two times daily and answer quality of~     life questionnaires during this study. Participants will also be seen by a dermatologist and~     have pictures taken of their rash.~   "
143223|NCT01692613|"~     Background:~      The immediate endoscopic identification and diagnosis of intraepithelial structures and~     immediate and delayed reactions to allergens in the mucosal surface of the gut are unmet~     goals in the diagnosis and management of subjects with food intolerances, who are negative to~     all available tests. Endomicroscopy may be helpful to further visualize and characterize~     unmasked small bowel reactions to foods, which has not been described before.~      Confocal laser endomicroscopy provides confocal microscopic imaging simultaneously to the~     macroscopic view ,which enables the examiner to see immediate reactions after exposure and it~     further allows capturing of fluid excreted by the gut for further analysis to understand the~     pathology behind this reaction further.~      N=50 patients with unexplained bloating and diarrhoea with suspicion of food intolerance and~     negative testing with routine methods. Patients with Lactose intolerance n=10 patients to~     compare results. Patients with Fructose intolerance n=10 patients to compare results.~     Volunteers with Barrett's esophagus who need evaluation for possible dysplasia in the~     Barrett's mucosa with confocal endomicrosopy but no symptoms of bloating and abdominal pain~     (n=10) to serve as healthy controls for allergy testing.~      Methods:~      The primary objective is to investigate whether endomicroscopy will allow the detection of an~     allergic reaction of the gut after exposure of the 5 major allergens in the following way:~      After standard gastroscopy with the endomicroscope including evaluation of the surface of the~     upper gastrointestinal tract, i.v. injection of Fluorescein, then initial visualisation of~     the duodenal surface including count of initial lymphocytes/mononuclear cells in the lamina~     propria: Allergen 1 (milk), allergen 2 (wheat), allergen 3 (soya),allergen 4 (apple),~     allergen 5 (yeast).~      The primary endpoint is the visible marked increase of lymphocytes and mononuclear cells in~     the lamina propria of the duodenum, representing an acute reaction to one of the allergens~     sprayed to its surface through the endoscope channel.~   "
143224|NCT01692600|"~     Radiation therapy of the head and neck cancer patients causes late oral radiation~     complications such as xerostomia (dry mouth) or mucosal atrophy. Currently, methods such as~     hyperbaric oxygen are used to treat these complications; however, there are no quantifiable~     means of assessing the outcome of these methods. At present, subjective methods such as~     superficial examination of the oral cavity are used, yet complications are known to mostly~     start in the subsurface layers. In this feasibility study, we apply an imaging technique~     called optical coherence tomography (OCT) as a means of providing objective and quantifiable~     images of the subsurface micro-structural and micro-vascular changes of oral tissue.~     Depth-resolved, micrometer-resolution OCT images provide information on changes associated~     with late radiation complications.~   "
143225|NCT01692587|"~     The Purpose of the Protein Study is to investigate whether a reduced protein diet can inhibit~     the growth of prostate cancer in humans.~      The Investigators hypothesis is that a reduced protein diet will inhibit expression of genes~     that are involved in the growth of prostate cancer.~   "
143226|NCT01692574|"~     To determine whether individuals who suffer from depression and obesity are able to lose~     weight and show improvements in mood and cardiovascular disease risk factors following 20~     weeks of a combined treatment of cognitive-behavior therapy for depression and behavior~     modification for weight loss. Participants will be assigned to one of three treatments: 1)~     cognitive-behavior therapy for the treatment of depression combined with an alternative~     approach to weight loss, 2) a weight loss intervention combined with a depression support and~     education , or 3) cognitive-behavioral therapy for depression combined with a weight loss~     intervention.~   "
143227|NCT01692561|"~     The purpose of this research study is to better understand what causes dysautonomia and how~     this affects blood pressure and pulse. Dysautonomia is a condition of the autonomic nervous~     system. It is associated with fluctuations in blood pressure and pulse and may cause symptoms~     of nausea and belly pain, fatigue, excessive thirst, lightheadedness, dizziness, feelings of~     anxiety or panic, and fainting. A common example of dysautonomia is postural orthostatic~     tachycardia syndrome or POTS. Sometimes symptoms worsen when people move from lying down to~     standing, called orthostatic intolerance. We would like to learn more about the link between~     orthostatic intolerance and nausea. While medications currently used to treat orthostatic~     intolerance and nausea have proven to be effective in some patients, this may not be the best~     treatment for everyone as long term use could pose certain risks including high blood~     pressure. In order to provide a more focused and safer treatment for patients suffering from~     nausea and orthostatic intolerance, we have looked at how the blood pressure, pulse, and~     certain blood tests change during a tilt table test. This test helps to create the same~     circumstances that patients with orthostatic intolerance experience when they stand. To~     better understand if some of these problems are associated with the brain, we will study MRI~     in patients with dysautonomia compared to children without dysautonomia. This information may~     allow us to use alternative and safer treatments in the future.~   "
143228|NCT01692548|"~     Forty children considered at risk for ADHD (subclinical ADHD) will be randomized to either a~     neurofeedback intervention or waiting list.~   "
143229|NCT01692535|"~     In this multicenter study the investigators are going to evaluate the use of six different~     videolaryngoscopes in patients undergoing elective surgery requiring general anesthesia with~     intubation. The investigators are hypothesizing that these six videolaryngoscopes will~     succeed for intubation at first attempt in at least 90% of all cases using a difficult airway~     simulation with extrication collars. As gold standard, a standard Macintosh blade is being~     used.~      The study consists of 6 arms. Each arm includes 120 patients, sums up to a total of 720~     patients.~   "
143230|NCT01692522|"~     The investigators will evaluate the first attempt visualized blind intubation through an Ambu~     Aura-i versus an AirQ.~   "
143231|NCT01692509|"~     The practices and processes related to the administration of noninvasive ventilation (NIV) in~     the adult intensive care unit (ICU) of the University hospital of Lausanne will be recorded~     by an investigator at the bedside. The effect of the NIV treatment on various respiratory~     parameters ( respiratory rate, expired tidal volume, minute ventilation) will also be~     recorded using a pneumotachograph. Finally patient's comfort during NIV treatment will be~     evaluated.~   "
143236|NCT01692444|"~     Airway remodelling is an abnormal tissue repair following bronchial inflammation, which~     contributes to none reversible pathological features, such as bronchial and peri-bronchial~     fibrosis. It also influences the prognosis of Chronic Obstructive Pulmonary Disease (COPD)~     and its mechanisms remain largely unknown. The role of fibrocytes has been demonstrated in~     the pathophysiology of asthma, lung fibrosis or pulmonary hypertension. However, the~     recruitment of blood fibrocytes and their involvement in COPD airway remodelling remain~     unknown.~      The main objective of the study is to analyse the distribution and quantify the number of the~     peri-bronchial and blood circulating fibrocytes in patients with different stages of COPD~     compared to control subjects.~   "
143237|NCT01692431|"~     The primary aim of this study is to determine the impact of individual fish oil fatty acids~     on vascular reactivity and to identify underlying physiological and molecular mechanism of~     any observed effects. In addition response to intervention according to genotype will be~     determined retrospectively.~   "
143238|NCT01692418|"~     Anaemia is a common problem in patients undergoing surgery. About half of patients undergoing~     a major operation have anaemia, often a consequence of the disease requiring surgery. Anaemia~     causes patients to feel tired and unwell. Anaemia at the time of surgery increases the~     requirement for blood transfusion (50% if anaemic compared to only 15% without anaemia). Both~     anaemia and blood transfusions are associated with increased complications from surgery,~     delayed recovery and prolonged hospital stay. The investigators propose that giving~     intravenous iron before operation can be used to correct anaemia in these patients.~     Consequently if patients are not anaemic they are less likely to need blood transfusion. Also~     patients feel better and their health is improved before their operation they are more likely~     to tolerate the surgery, recover faster, be less likely to have complications from surgery~     and return home sooner. This will have benefits to the individual patient and also to the NHS~     by reducing costs.~      Oral Iron tablets are not effective as they take 3-6 months to increase blood levels, the~     tablets are often not tolerated as cause constipation or stomach pain, overall only 30-50% of~     people continue taking oral iron. A full treatment dose of intravenous iron can be given in~     15 minutes with minimal side effects. The effect is to rapidly increase blood counts in 2-4~     weeks. The investigators propose that this treatment can be incorporated to patient~     preparation pathways for surgery as an outpatient without the need for additional visits to~     hospital.~      Small studies have suggested a benefit of iron therapy in orthopaedic and gynaecological~     surgery. This study will look at 500 patients undergoing major surgery at 20 hospitals in the~     UK. The investigators anticipate half of patients treated will have their anaemia corrected~     before operation. Patients with anaemia will be identified as part of the routine blood tests~     taken preoperatively and invited to take part in the study. Following informed consent, they~     will be randomly allocated to receive either intravenous iron or a placebo infusion of~     saline. Intravenous iron is a dark liquid given continuously into a vein over 15 minutes. To~     ensure neither doctor nor patient knows which treatment is being given both infusions will be~     prepared and administered by an unblinded authorised person via a black bag through black~     tubing. There will be no other changes to the patient's normal treatment.~      The main aim of this study is to assess if intravenous iron will reduce the need for blood~     transfusion in the time period around the operation. Further outcome measures will include;~     patient-reported quality of life, complications, length of hospital stay, and cost. Outcomes~     will be assessed both during hospital stay and after the patient has been discharged. The~     trial will be run through a Clinical Trials Unit with considerable experience in conducting~     large trials. The team has a large range of experience in anaemia management and assessment~     of complications, quality of life and the cost of health care.~      The main aim of this study is to assess if intravenous iron will reduce the need for blood~     transfusion in the time period around the operation. Further outcome measures will include;~     patient-reported quality of life, complications, length of hospital stay, and cost. Outcomes~     will be assessed both during hospital stay and after the patient has been discharged. The~     trial will be run through a Clinical Trials Unit with considerable experience in conducting~     large trials. The team has a large range of experience in anaemia management and assessment~     of complications, quality of life and the cost of health care.~   "
143239|NCT01692405|"~     Performance evaluation of a novel, semi-automated device and method for needle core biopsy~     download compared to standard methods in terms of:~        1. Biopsy core length obtained (i.e. collecting all tissue fragments)~        2. Biopsy core yield (i.e. percent of tissue loss during the pathologic processing)~        3. Pathologist interpretability~        4. Processing time~        5. Prostate cancer detection.~   "
143240|NCT01692392|"~     The purpose of the study is to assess changes in health-related quality of life in patients~     undergoing surgical correction of pectus carinatum. In addition, the study assessed long-term~     effects of surgical intervention in relation to the development of persistent postoperative~     pain and / or sensory disturbances in the surgical field.~   "
143241|NCT01692379|"~     To evaluate the hypothesis that mechanical embolectomy with the Solitaire FR device is~     superior to medical management alone in achieving favorable outcome in the distribution of~     the modified Rankin Scale scores at 90 days in subjects presenting with acute large vessel~     ischemic stroke < 8 hours from symptom onset.~   "
143242|NCT01692366|"~     Primary Objective:~      - To evaluate the efficacy of daily oral doses of 300 mg, 400 mg, and 500 mg SAR302503 and~     combined for the response rate defined with the ≥35% reduction of spleen volume as determined~     by magnetic resonance imaging (MRI or computed tomography scan [CT] in patients with~     contraindications for MRI).~      Secondary Objectives:~        -  To evaluate the safety of SAR302503 for both pooled (300, 400, and 500mg) and individual~          doses population.~        -  To evaluate the pharmacokinetics (PK) of SAR302503 after single and repeat-dose.~        -  To evaluate the effect on Myelofibrosis (MF)-associated symptoms (Key MF symptoms) as~          measured by the modified Myelofibrosis Symptom Assessment Form (MFSAF).~        -  To evaluate the durability of splenic response.~        -  To evaluate the effect of SAR302503 on bone marrow with regard to changes on reticulin~          fibrosis.~   "
143243|NCT01692353|"~     This cross-sectional study was primarily a cardiovascular disease (CVD) study designed a) to~     compare selected CVD biomarker data between subjects who were long-term consumers of~     cigarettes or moist snuff and non-consumers of tobacco and b) to identify principal endpoints~     related to CVD risk that differed among the three tobacco-use cohorts. The following~     assessments provided the primary study endpoints for comparative analyses between the~     cohorts:~        1. CVD-related physiological assessments: Flow-mediated dilation (FMD), carotid~          intima-media thickness (CIMT), ankle-brachial index (ABI), spirometry and expired carbon~          monoxide (ECO).~        2. CVD-related biomarker assessments in blood and urine (biomarkers of tobacco effect).~        3. Biomarkers of tobacco exposure in urine and blood.~   "
143244|NCT01692340|"~     Tomatoes contain several compounds which may be beneficial for human health and prevention of~     disease, although this relationship is poorly understood and very controversial. This study~     uses a new technology to study the absorption and metabolism of three different compounds~     found in tomatoes. These compounds are called: phytoene, phytofluene, and lycopene. We~     hypothesize that by studying the absorption and metabolism of these compounds, we may be able~     to understand how the compounds may influence health and disease processes.~   "
143245|NCT01692327|"~     The hypothesis of the proposed project is that after a fat overload, the postprandial~     response is different in both groups, suggesting that the LPP will present the most~     significant damage in endothelial vasomotion in obese individuals, especially those with GI~     and T2DM. After the fat overload, we hypothesized that there will be a worsening of~     endothelial function and microvascular reactivity in OB/DM2 and OB group compared to C, but~     also find lower concentrations of incretins in OB/DM2 group compared to other groups.~      These hypotheses may be confirmed by techniques for evaluating microvascular function, the~     use of DFT skin for vasomotion evaluation and finally analysis of analytes through metabolic~     and cardiovascular read by Multiplex kit.~   "
143248|NCT01692288|"~     The purpose of this study is to determine if children and mothers who participate in the~     First Born® Program (FBP) experience better outcomes than they would have in the absence of~     the program. The evaluation employs a randomized trial design to assess the effectiveness of~     the FBP in the Santa Fe County, NM, site. FBP is a home visitation program that uses~     clinically trained professionals to provide first-time parents with information, training,~     and access to resources designed to promote early childhood development. Services are free~     and may begin at any time during pregnancy or up to two months after the baby's birth and may~     continue until the child is three years old. In addition, a nurse postpartum home visit is~     offered to the parents of all participating newborns. The FBP model builds on other home~     visiting and prevention programs that have been shown to improve long-term outcomes of~     children and their families.~   "
143249|NCT01692275|"~     The purpose of this study is to evaluate the effectiveness of chiropractic manipulative~     therapy for pain management and improved function in active duty service members with low~     back pain that do not require surgery. The study will also measure the impact of a tobacco~     cessation program delivered to participants allocated to the chiropractic arm.~   "
143250|NCT01692262|"~     To investigate the safety, tolerability and anti-tumour activity of AZD5363, as monotherapy,~     in patients with metastatic Castrate-Resistant Prostate Cancer. AZD5363 will be investigated~     in patients who have progressed after chemotherapy (Part A) and in patients who have~     progressed before receiving chemotherapy (Part B).~      Recruitment into Part A, Group 1 has been suspended. A new design for this group is currently~     being evaluated. Part A, group 2 patients (progressed after 1 or more 2nd generational~     anti-hormonal therapies) will receive AZD5363 480mg bid intermittently (4 days on/3days off).~      Part B will only start if there is evidence of anti-tumour activity along with AZD5363 having~     an acceptable safety profile in Part A. Part B will be conducted in pre-chemotherapy patients~     on a dose and schedule selected from Part A.~   "
143251|NCT01692249|"~     To determine whether spa therapy has a beneficial effect on pain and disability in the~     management of shoulder pain due to chronic rotator cuff lesions, this multicentre randomized~     prospective clinical trial includes patients with shoulder pain due to chronic degenerative~     rotator cuff tendinopathy who attend French spa resorts as outpatients. Subjects are~     randomized into two groups: immediate spa therapy (18 days of standardized treatment) and~     control (spa therapy delayed for 6 months). All patients continue usual treatments during the~     6-month follow-up period. The main endpoint is the mean change in the DASH score at 6 months.~     Secondary endpoints are the mean change in SF-36 components, treatments used, and tolerance.~     The effect size of spa therapy is calculated and the proportion of patients reaching minimal~     clinically important improvement (MCII) is compared between groups.~   "
143252|NCT01692236|"~     Background:~      - Human immunodeficiency virus (HIV) infection appears to cause problems with blood vessel~     function. These problems may add to some thinking and mood disorders found in people with HIV~     infection. Researchers want to evaluate HIV infected patients to see if blood vessel function~     contributes to thinking and mood disorders, such as early dementia and depression. To do so,~     they will compare study results between people with and people without HIV infection.~      Objectives:~        -  To compare the thickness of blood vessel walls between people with and without HIV~          infection.~        -  To study the relationship between blood vessel thickness and thinking and mood~          disorders.~      Eligibility:~        -  Individuals between 25 and 55 years of age who have HIV infection.~        -  Healthy individuals between 25 and 55 years of age.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected.~        -  Participants will have imaging studies of the brain and major blood vessels in the head~          and neck.~        -  Participants will also have neuropsychological testing. These tests will look at memory,~          learning and thinking ability, attention, and mood.~        -  Participants will have the option of coming back for repeat blood tests every six months~          and repeat imaging studies and neuropsychological tests every year, over 1- 4 years~          period.~   "
143253|NCT01692223|"~     This study uses new methods called genome sequencing that allow the investigators to study~     part or all of a person's genome. The genome is the collection of all of a person's genes.~     Genes carry the instructions that our bodies need to develop and function. Genes are passed~     on from one generation to the next. Genome sequencing can study all of a person's genome~     (whole genome sequencing) or just parts of their genome (whole exome sequencing). In the~     study, the investigators refer to all these research methods as 'genome sequencing'. Genome~     sequencing typically shows a large number of gene changes, known as variants. Some (but not~     all) of these genetic variants may be linked to increased risks of diseases other than~     cancer.~      The purpose of this study is to learn what kinds of genetic variants the patient wants to~     learn about from their genome.~   "
143254|NCT01692210|"~     The goal of this research study is to learn about how dexmedetomidine (a standard of care~     sedative) affects your immune system (your defenses against cancer) by measuring your white~     blood cell levels before and after surgery.~   "
143255|NCT01692197|"~     The goal of this clinical research study is to learn if E7070 in combination with idarubicin,~     cytarabine, and dexamethasone can help to control the disease in patients with either AML or~     high-risk MDS that has relapsed. The safety of the drug combination will also be studied.~   "
143256|NCT01692184|"~     This is a 2-part study. The first part is to evaluate the safety, pharmacokinetics (PK) and~     pharmacodynamics of AVL-292 following multiple oral doses; and the second part is to evaluate~     the effect of food on the pharmacokinetics of a single oral dose of AVL-292.~   "
143257|NCT01692171|"~     The hypothesis of this trial is that the test drug (Enoxalow® - T) pharmacodynamics~     parameters are similar to the comparator drug (Clexane® - C) in healthy subjects following~     administration of single intravenous dose. The objective of this randomized, crossover,~     clinical trial is to evaluate the pharmacodynamic profile of the test drug Enoxalow® - T~     produced by Blau Farmacêutica, compared to the comparator drug Clexane®, produced by~     Sanofi-Aventis, by determining pharmacodynamic activities (including anti FXa and anti-FIIa),~     as surrogate markers for their circulating concentrations of the drug.~   "
143281|NCT01691859|"~     This is a multi-centre, open-label long term safety study of 100 milligrams (mg) mepolizumab~     administered subcutaneously (SC) in addition to standard of care in subjects who participated~     in the MEA112997 study. At each clinic visit, adverse events will be assessed and~     exacerbations will also be reviewed.~   "
143258|NCT01692158|"~     The hypothesis of this trial is that the test drug (Enoxalow® - T) pharmacodynamics~     parameters are similar to the comparator drug (Clexane® - C) in healthy subjects following~     administration of single subcutaneous dose. The objective of this randomized, crossover,~     clinical trial is to evaluate the pharmacodynamic profile of the test drug Enoxalow® - T~     produced by Blau Farmacêutica, compared to the comparator drug Clexane®, produced by~     Sanofi-Aventis, by determining pharmacodynamic activities (including anti FXa and anti-FIIa),~     as surrogate markers for their circulating concentrations of the drug.~   "
143259|NCT01692145|"~     The purpose of this study is to evaluate the efficacy and safety of KCT-0809 compared to~     placebo in patients with dry eye syndromes.~   "
143260|NCT01692132|"~     The purpose of this study is to determine the safety and effectiveness of prucalopride in the~     treatment of Filipino patients with chronic constipation whom prior laxatives fail to provide~     adequate relief.~   "
143261|NCT01692119|"~     The aim of the study is to investigate whether a continuous interdisciplinary intervention~     improves medication adherence and leads to a reduction of hospitalizations and mortality in~     elderly patients with chronic heart failure. The intervention, consisting of regular contacts~     with the local pharmacy and weekly dosing aids, aims to improve medication adherence and~     management.~   "
143262|NCT01692106|"~     This study evaluates the feasibility of endoscopic myotomy for achalasia. In achalasia, there~     is loss of relaxation of the lower esophageal sphincter (LES), as well as a higher baseline~     pressure in the LES. The most widespread treatment for this disease and the one that has the~     best long term results involves cutting the muscle layers of the lower esophagus and on the~     neighbouring stomach without injurying the underlying mucosa or inner layer of the esophageal~     wall. This is done during a surgery through the abdomen either with a big incision or more~     recently with the keyhole technique. This surgery has various potential complications, one of~     which being making a hole through the mucosa or not extending the cut on the muscle long~     enough to obtain adequate relaxation of the sphincter. The per oral endoscopic myotomy (POEM)~     is a new intervention that is done also under general anesthesia in the operating room;~     however, it involves no skin incisions and all the procedure is done through a fiber optic~     camera. It involves making a cut in the inner layer of the esophagus and then with cautery~     cut the muscle fibers responsible of the blockage and finally closing the initial opening~     with clips. In this study we will investigate the feasibility of this intervention both from~     a technical aspect as well as a logistical perspective given the local operating room~     constraints.~   "
143263|NCT01692093|"~     The purpose of this study is to determine clinical efficacy and safety of KM110329 for Atopic~     dermatitis.~   "
143264|NCT01692080|"~     The primary objective of this study is to document the prevalence and associations between~     asthma, hypertension, and obesity in children living in Pittsburgh, Pennsylvania and its~     surrounding regions.~      The secondary objective is to determine the impact of various educational interventions on~     child and caregiver knowledge of asthma.~   "
143265|NCT01692067|"~     The purpose of this study is to determine potential risk factors for physical and sexual~     assault in regular military women (as opposed to Reserve and National Guard). In addition,~     this study seeks to determine associations between service women's violence exposures and:~     current physical and mental health status (e.g. PTSD), and access to and use of DoD, DVA and~     civilian healthcare.~   "
143266|NCT01692054|"~     The aim of the study is to improve the prognosis of the development of alcohol consumption by~     considering a variety of biological, psychological and social risk and protective factors.~     Therefore, young people who have been hospitalized due to acute alcohol intoxication within~     the past 5 to 12 years will be interviewed in order to assess aspects of healthy or impaired~     psychosocial development. The study will also include a control group of young adults who~     were in hospital due to other medical conditions. The identification of relevant cases will~     be based on medical records of several children's hospitals. These records will be analysed~     with regard to potential predictors of developmental hazards and protective factors.~   "
143267|NCT01692041|"~     The trial aims to record possible effects of a supplementary treatment with ivy leaves dry~     extract on different lung function parameter, on bronchial hyperreactivity, on individual~     markers of asthmatic inflammation and on the clinical symptom profile. The hypothesis is,~     that the additional therapy might improve these parameters and might help to optimize asthma~     therapy.~   "
143268|NCT01692028|"~     Hypothesis: low vitamin D status is associated with increased insulin resistance and~     increased blood pressure.~      Approach: Multiple regression analysis of information extracted from a large database~     accumulated by a Canadian health foundation, specifically evaluating statistical associations~     between serum 25(OH)D levels and insulin responsiveness measures as well as blood pressure,~     after adjusting these variables for BMI, age, sex, and waist circumference.~   "
143269|NCT01692015|"~     Hereditary Haemorrhagic Telangiectasia (HHT) affects 1 in 5,000 people. The purpose of this~     study is to provide data regarding the diet and nosebleed frequency using a questionnaire.~      This will be filled in by people with HHT.~      The questionnaire has been designed in paper format.~   "
143270|NCT01692002|"~     The aim of these studies is to firstly determine the pharmacokinetic profile of orally~     administered enteric coated sodium propionate. Subsequently, the most efficacious dose at~     improving glucose tolerance following an oral glucose challenge will be determined. The~     investigators will then determine the mechanism of action of propionate, whether it acts by~     altering beta cell function directly or by augmenting the incretin effect or both~   "
143271|NCT01691989|"~     This multicenter, randomized, double-blind, placebo-controlled study will assess the~     efficacy, safety and tolerability of aleglitazar compared with placebo when added to a~     sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy in patients with~     type 2 diabetes mellitus who are inadequately controlled with sulfonylurea alone or~     sulfonylurea plus metformin therapy. Patients will be randomized to receive oral doses of 150~     mcg aleglitazar once daily or placebo. The anticipated time on study treatment is 26 weeks.~   "
143296|NCT01691664|"~     Cytokine-induced killer (CIK) cells show cytolytic activity against tumor. Radiation therapy~     uses high-energy x-rays to damage tumor cells. Combining Radiation therapy with adoptive~     cellular therapy after surgery may be more effective than uses radiation therapy alone in~     treating esophageal cancer.~   "
143272|NCT01691976|"~     MCI with ageing is thought in part to be related to reduced serum sex hormones which is~     well-recognised, especially in females, but poorly understood. International studies~     assessing hormone replacement therapy (HRT) to prevent/reduce MCI are ongoing. MCI leads to~     morbidity, reduced quality of life and substantial healthcare costs. The commonest~     therapeutically induced reduction in sex hormone level in men is treatment of prostate cancer~     (PCa). PCa is androgen dependent and androgen-deprivation therapy (ADT) suppressing~     testosterone to castrate levels is key therapy for advanced disease. About one million men~     worldwide have received ADT for PCa, mostly using luteinising hormone releasing-hormone~     agonists (LHRHa) although oral oestrogens were used in the past; eventually perhaps 4% of~     Caucasians may be castrated. MCI as a side-effect of castration in men remains poorly~     researched. This pilot study will quantify the extent of MCI in men receiving ADT with LHRHa~     and oestrogen to inform the design of a larger study to understand mechanisms, predict~     affected patients and determine ways of reducing MCI. Researching relationships of sex~     hormones and MCI should improve understanding and interventions for slowing/preventing MCI in~     PCa survivors. HRT in women slows MCI. Alternatives for ADT include parenteral oestrogen. The~     PATCH clinical trial comparing transdermal oestrogen with LHRHa offers an opportunity to~     assess oestrogen as preventative for male MCI. Functional magnetic resonance imaging (fMRI),~     quantitative electroencephalography (qEEG) and neuropsychological tests will be used to test~     this hypothesis.~   "
143273|NCT01691963|"~     Usually videolaryngoscopy using a videolaryngoscope with a classic Macintosh design is~     performed with the blade in the vallecula and the epiglottis elevated from the vocal cords~     indirectly, as in direct laryngoscopy. However, during an audit of videolaryngoscopic~     practice we noticed that, in obtaining the best view, clinicians frequently and inadvertently~     advanced the blade into the vallecula to get a better view, such that the epiglottis was~     downfolded and elevated directly from the vocal cords. However, a better view does not~     necessarily lead to higher intubation success.~      In this randomized, controlled trial, we want to determine the efficacy of~     videolaryngoscope-guided tracheal intubation using an alternative position for the blade in~     patients with normal airways.~   "
143274|NCT01691950|"~     This is an observational study, which aims to firstly develop a sensor-based objective~     mobility assessment. This will then be used to profile and compare the outcomes of patients~     who undergo amputation with those who have limb salvage surgery following a traumatic injury~     to their lower limb.~   "
143275|NCT01691937|"~     Patients often experience moderate to severe postoperative pain, especially during the first~     hours after hepatectomy. Systemic opioids given with patient-controlled analgesia has be used~     after hepatectomy in many medical center(Aubrun, Monsel et al. 2001; Aubrun, Salvi et al.~     2005), but the analgesic effect can be limited and undesirable side effects may occur.~      A case report described that right thoracic paravertebral block reduced pain and analgesic~     requirements after right lobe hepatectomy(Ho, Karmakar et al. 2004). Compared with epidural~     analgesia, thoracic paravertebral block probably carries a much lower risk of spinal~     haematoma in the presence of moderate haemostatic deficiencies (Richardson and Lonnqvist~     1998; Karmakar 2001).~      We therefore designed a prospective, randomized, subject and assessor blinded,~     parallel-group, placebo controlled study to test the hypothesis that continuous right~     thoracic paravertebral analgesia decreases opioid consumption during the first 24 h after~     right lobe hepatectomy in patients receiving i.v. patient-controlled analgesia (PCA) with~     sufentanil.~   "
143276|NCT01691924|"~     No clinical trials with PBF-509 in humans have been performed to date. Only preclinical~     studies have been done to assess the pharmacology and pharmacokinetics, the safety and the~     toxicological profile of the PBF-509.~      An initial testing of PBF-509 in humans is planned, starting with the first-into-man clinical~     trial where a single oral, dose-escalating, and placebo-controlled design will be~     implemented.~   "
143277|NCT01691911|"~     Major vascular surgery involves operations to repair swollen blood vessels, clear debris from~     blocked arteries or bypass blocked blood vessels. Patients with these problems are a~     high-risk surgical group as they have generalized blood vessel disease. These puts them at~     risk of major complications around the time of surgery such as heart attacks , strokes and~     death. The mortality following repair of a swollen main artery in the abdomen is about 1 in~     20. This contrasts poorly with the 1 per 100 risk of death following a heart bypass. Simple~     and cost-effective methods are needed to reduce the risks of major vascular surgery. Remote~     ischaemic preconditioning (RIPC) may be such a technique. To induce RIPC, the blood supply to~     muscle in the patient's arm is interrupted for about 5 minutes. It is then restored for a~     further five minutes. This cycle is repeated three more times. The blood supply is~     interrupted simply by inflating a blood pressure cuff to maximum pressure. This repeated~     brief interruption of the muscular blood supply sends signals to critical organs such as the~     brain and heart, which are rendered temporarily resistant to damage from reduced blood~     supply. Several small randomized clinical trials in patients undergoing different types of~     major vascular surgery have demonstrated a potential benefit. This large, multi-centre trial~     aims to determine whether RIPC can reduce complications in routine practice.~   "
143278|NCT01691898|"~     This multicenter, open-label study will evaluate the safety and efficacy of pinatuzumab~     vedotin (DCDT2980S) or polatuzumab vedotin (DCDS4501A) in combination with rituximab (RTX),~     as well as of polatuzumab vedotin in combination with obinutuzumab in participants with~     relapsed or refractory (r/r) follicular lymphoma (FL) and r/r diffuse large B-cell lymphoma~     (DLBCL).~   "
143279|NCT01691885|"~     The primary objective of the study is to test the hypothesis that lung hyperinflation~     contributes to cardiac dysfunction in COPD and that the treatment of lung deflation with~     FF/VI Inhalation Powder 100/25 mcg administered once daily (QD) will result in the reversal~     of this cardiac dysfunction compared with placebo. This will be assessed by measures of right~     and left global and regional systolic and diastolic cardiac function as assessed using a 30~     minute CMR.~      A secondary objective will be to investigate the effect of FF/VI inhalation powder 100/25mcg~     QD on measures of arterial stiffness in the form of pulse wave analysis and distensability in~     the pulmonary and systemic circulation.~   "
143280|NCT01691872|"~     This is an open-label, single centre, parallel group study to evaluate the safety and~     pharmacokinetics of single oral doses of retigabine XR formulation in healthy adult Japanese~     subjects. To compare the pharmacokinetic and safety profile, Caucasian subjects are also~     incorporated. This study is intended to facilitate inclusion of Japanese patients in the~     global phase III program for retigabine XR formulation.~   "
143282|NCT01691846|"~     This multicenter, randomized, double-blind, placebo-controlled study will assess the~     efficacy, safety and tolerability of aleglitazar plus metformin combination therapy compared~     with placebo plus metformin in patients with type 2 diabetes mellitus who are inadequately~     controlled with metformin monotherapy. Patients will be randomized to receive oral doses of~     150 mcg aleglitazar once daily or placebo. The anticipated time on study treatment is 26~     weeks.~   "
143283|NCT01691833|"~     The purpose of the study is to determine whether vitamin D supplementation in patients with~     hypovitaminosis D can decrease nonunion (failure to heal) incidence in patients with~     fractures of the humerus, femur, or tibia. The central hypothesis of the study is that~     vitamin D supplementation in patients with fractures and hypovitaminosis D will decrease the~     risk of nonunion compared to placebo treatment.~   "
143284|NCT01691820|"~     The purpose of this study is to estimate the incidence of CMV secondary infections~     (re-infections/re-activations) and the incidence of CMV primary infections in adolescent~     females.~   "
143285|NCT01691807|"~     The purpose of this study is to evaluate the potential drug-drug interactions between~     ofatumumab and bendamustine in subjects with previously untreated or relapsed indolent B-cell~     non-Hodgkin's lymphoma (NHL).~   "
143286|NCT01691794|"~     The purpose of this study is to collect safety clinical data in HIV-infected pediatric~     patients aged 6 and older to younger than18 years and weighing 15 kg or more, who are~     receiving atazanavir capsule boosted with ritonavir and an optimized nucleoside reverse~     transcriptase inhibitor backbone therapy as part of their antiretroviral regimen.~   "
143287|NCT01691781|"~     This study will evaluate whether commonly used blood pressure medications called ACE~     inhibitors can lower parathyroid hormone.~   "
143288|NCT01691768|"~     The purpose of this study is to assess the effectiveness of an implementation model which~     integrates tenofovir gel provision into existing family planning services.~   "
143289|NCT01691755|"~     This multicenter, randomized, double-blind, placebo-controlled study will assess the~     efficacy, safety and tolerability of aleglitazar monotherapy compared with placebo in~     patients with type 2 diabetes mellitus who have not previously received anti-hyperglycemic~     therapy. Patients will be randomized to receive oral doses of 150 mcg aleglitazar once daily~     or placebo. The anticipated time on study treatment is 26 weeks.~   "
143290|NCT01691742|"~     A. Purpose To compare MiraLAX versus placebo for preventing constipation in the immediate~     postoperative period following pelvic reconstructive surgery in women taking routine docusate~     sodium.~      B. Objectives~        1. Specific Aims Specific Aim 1: To compare time to first bowel movement (BM) between~          MiraLAX versus placebo in women receiving routine docusate sodium after pelvic~          reconstructive surgery.~           Specific Aim 2: To compare patient reported outcomes of BM quality and associated~          gastrointestinal (GI) symptoms between MiraLAX versus placebo using the Bristol stool~          scale and the validated Patient Assessment of Constipation Symptom Questionnaire~          (PAC-SYM) in women receiving routine docusate sodium after pelvic reconstructive~          surgery.~           Specific Aim 3: To evaluate GI-related quality of life between MiraLAX versus placebo~          utilizing the validated Patient Assessment of Constipation Quality-of-Life Questionnaire~          (PAC-QOL) in women receiving routine docusate sodium after pelvic reconstructive~          surgery.~        2. Hypotheses The investigators hypothesize that MiraLAX will optimally prevent~          constipation following pelvic reconstructive surgery by decreasing time to first BM,~          decreasing GI symptoms associated with constipation, and increasing measures of~          GI-related quality of life, while minimizing the bothersome side effects associated with~          stimulant laxatives.~   "
143291|NCT01691729|"~     To purpose of the study is to evaluate and compare the efficacy of three ostomy accessory~     products.~   "
143292|NCT01691716|"~     The purpose of this study is to determine whether Tendoactive, eccentric training, or the~     combination or both could be effective in the treatment of Achilles tendinopathy.~   "
143293|NCT01691703|"~     A difficult tracheal intubation can be a problem, even if one has taken all precautions. A~     possible solution can be using a videolaryngoscope in conjunct with the Bonfils® intubation~     scope. As such, the videolaryngoscope can be used to achieve the best possible view and space~     of the laryngeal inlet for the insertion and manoeuvring of the Bonfils® intubation scope.~   "
143294|NCT01691690|"~     Acetaminophen (paracetamol) is a first-line antipyretic and analgesic for mild and moderate~     pain for pediatric patients. Its common use (particularly in oral form) is underscored by its~     wide therapeutic window, safety profile, over the counter accessibility, lack of adverse~     systemic effects (as compared with NSAIDS and opioids) when given in appropriate doses.~      Although the exact anti-nociceptive mechanisms of acetaminophen continue to be elucidated,~     these mechanisms appear to be multi-factorial and include central inhibition of the~     cyclo-oxygenase (COX) enzyme leading to decreased production of prostaglandins from~     arachidonic acid, interference with serotonergic descending pain pathways, indirect~     activation of cannabinoid 1 (CB1) receptors and inhibition of nitric oxide pathways through~     N-methyl-D-aspartate (NMDA) or substance P. Of the above mechanisms, the most commonly known~     is that of central inhibition of COX enzymes by which the decreased production of~     prostaglandins diminish the release of excitatory transmitters of substance P and glutamate~     which are both involved in nociceptive transmission (Anderson, 2008; Smith, 2011).~      To date, several studies have shown acetaminophen's opioid sparing effect in the pediatric~     population when given by the rectal or intravenous routes (Korpela et al, 1999; Dashti et al,~     2009; Hong et al, 2010).~   "
143295|NCT01691677|"~     Intranasal corticosteroids are beneficial in the treatment of acute rhinosinusitis. As~     adjunctive therapy to oral antibiotic treatment, mometasone furoate at doses of 200 μg or 400~     μg twice daily, was well tolerated and significantly more effective in reducing the symptoms~     of rhinosinusitis than antibiotic therapy alone. Furthermore,the addition of fluticasone~     propionate to xylometazoline and antimicrobial therapy with cefuroxime improved clinical~     success rates and accelerated recovery of patients with a history of chronic rhinitis or~     recurrent sinusitis who present for treatment of acute rhinosinusitis.~      The present study was planned to assess the effects of nebulised beclomethasone dipropionate~     given as add-on therapy to standard care (oral antibiotics) in the treatment of acute~     symptomatic rhinosinusitis. Antibiotic therapy will be at the physicians' discretion.~   "
143299|NCT01691625|"~     The purpose of this study is to show if the adoptive cellular therapy with autologous~     dendritic cells and cytokine-induced killer cells (CIK) combined with concurrent~     chemoradiation could improve the quality of life of the patients with locally advanced~     esophageal cancer, compared with concurrent chemoradiation only.~   "
143300|NCT01691612|"~     Pin1 is activated in asthmatic airways, increasing cytokine mRNA stability and eosinophil~     survival. This study is designed to test whether the Pin1 enzyme regulates TLR/IL-1R signal~     pathways in multiple cells in asthma.~   "
143301|NCT01691599|"~     The objectives of this study are to investigate infection rates and management for open and~     closed tibia fracture subjects in India treated with internal fixation. These objectives will~     be carried out by answering the following questions:~        1. What is the infection rate within one year of surgery for open and closed tibia fracture~          subjects in India treated with internal fixation?~        2. What is the distribution of infection per type of infection, stratified by time (early,~          delayed, late) and location (superficial or deep) in open and closed tibia fracture~          subjects in India treated with internal fixation?~      Secondary objectives~        1. How are infections managed in open and closed tibia fracture subjects in India treated~          with internal fixation?~        2. What is the treatment outcome for open and closed tibia fracture subjects in India~          treated with internal fixation?~        3. What is the influence of the following clinic and subject factors on the occurrence of~          infection within one year for open and closed tibia fracture subjects in India treated~          with internal fixation?~             1. Hospital standard hygienic and antibiotic protocol for infection prevention~             2. Subject demographics~             3. Time between injury and surgery and between admission and surgery~             4. Fracture type (AO Müller classification)~             5. Soft tissue damage (according to the Tscherne classification for closed fractures~               or Gustilo classification for open fractures)~             6. Fracture management and implant type~             7. Surgical details such as duration of surgery~        4. Is there a difference in health-related quality of life as measured by the EuroQol-5~          Dimensions (EQ-5D) between subjects with and without infections?~        5. Is there a difference in the number of complications not related to infection (adverse~          events and serious adverse events) between subjects with and without infections?~   "
143302|NCT01691586|"~     A relatively new and promising development in the area of cardiovascular implantable~     electronic device therapy is remote patient monitoring (RPM). RPM systems can interrogate the~     device automatically and send the data from the patients' home to the physician, thereby~     reducing in-clinic follow-ups.~      The purpose of this study is to evaluate the effect of RPM + in-clinic follow-up versus~     in-clinic follow-up only on patient-reported health status and device-acceptance after~     implantation with an implantable cardioverter defibrillator (ICD) or cardiac~     resynchronization defibrillator (CRT-D).~      Secondary objectives are (1) to identify subgroups of patients who prefer RPM over in-clinic~     visits or vice versa due to specific clinical and psychological factors and (2) To~     investigate the cost-effectiveness of RPM + in-clinic follow-up compared to in-clinic~     follow-up only.~   "
143303|NCT01691573|"~     The main objective of the European Pediatric Catheter Ablation Registry is to collect data on~     ablation procedures in the European pediatric population in order to improve the management~     of this subset of patients.~   "
143304|NCT01691560|"~     The purpose of this exploratory study is to compare the treatment effect on dentinal~     hypersensitivity of a tubule occluding dentifrice as measured by Schiff and Tactile~     sensitivity. This proof of concept study will compare the test dentifrice with three other~     treatment groups.~   "
143305|NCT01691547|"~     This is a double-blind, single dose (four inhalations), four-way cross over study in healthy~     subjects that will assess the systemic pharmacokinetics (PK) and systemic pharmacodynamics~     (PD) of Fluticasone Furoate, (FF), Umeclidinium, (UMEC) and Vilanterol (VI). Study drug will~     be delivered through a novel single-step activation dry powder inhaler (NDPI) which has a two~     strip configuration. The NDPI will be configured with different combinations of each compound~     and also a new blend of UMEC/VI inhalation powder within a single strip of the NDPI device.~     Study drug will be administered through the inhaled route to healthy subjects in single doses~     (four inhalations). Each subject will receive treatment in a randomized order Treatment A FF~     (400 microgram [µg]) and UMEC (500 µg)/VI (100 µg), Treatment B UMEC (500 µg) and VI (100~     µg), Treatment C FF (400 µg) and VI (100 µg) and Treatment D FF (400 µg) and UMEC (500 µg)~     over four treatment periods. Each treatment period will be separated by a washout of 7 to 21~     days. After the four treatment periods, a follow up visit will take place 7 to 21 days~     following the final dose of study medication and the maximum duration a subject will be~     involved in the study is eighteen weeks.~      Pharmacokinetics will be assessed by the measurement of plasma and urine concentrations of~     FF, UMEC and VI. Safety and PD will be monitored using blood glucose, serum potassium, heart~     rate, 12-lead ECGs and clinical laboratory tests. Plasma samples for PK will be collected~     throughout the study, urine, blood glucose, serum potassium, heart rate, 12-lead ECGs and~     clinical laboratory tests will be assessed on Day 1 only. AEs will be assessed throughout the~     study.~   "
143306|NCT01691534|"~     The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral~     administration of TMC207 plus PA-824 plus Pyrazinamide plus Clofazimine, TMC207 plus PA-824~     plus Pyrazinamide, TMC207 plus PA-824 plus Clofazimine alone, TMC207 plus Pyrazinamide plus~     Clofazimine, Pyrazinamide alone, Clofazimine alone, and standard first line TB treatment as~     per South African TB Guidelines (Rifafour e-275) as determined by the rate of change of log~     CFU per ml sputum over the time period Day 0-14 in participants with smear positive pulmonary~     tuberculosis (TB). A control group will receive standard treatment.~   "
143307|NCT01691521|"~     This study will evaluate two dose regimens of mepolizumab [75mg intravenous (i.v.) or 100mg~     subcutaneous (SC) every 4 weeks] compared with placebo over a 32 week treatment period in~     subjects with severe refractory asthma with elevated blood eosinophils. Efficacy will be~     measured by a reduction in the frequency of asthma exacerbations. Additional efficacy~     assessments will include measurements of lung function, symptom scores, and quality of life.~     Safety will be assessed by clinical laboratory samples, ECGs, immunogenicity and adverse~     events.~      This study is intended to replicate the Phase IIb/III study MEA112997. Subjects in MEA115588,~     who meet all eligibility criteria at screening visit, will enter the run-in period. Those~     subjects that are not able/eligible to be randomised at the end of the 6 week run-in period~     will be deemed run-in failures. Subjects will remain on their current maintenance therapy~     throughout the run-in, double-blind treatment administration and follow-up periods. Subjects~     who meet the randomisation eligibility criteria will be randomised in a 1:1:1 ratio to~     receive one of the following treatments every 4 weeks for a total of 8 doses: Mepolizumab 75~     miligram (mg) i.v. and placebo SC, or Mepolizumab 100 mg SC and placebo i.v. or Placebo i.v.~     and placebo SC.~      Subjects that receive all 8 doses of double-blind treatment, and meet the eligibility~     criteria for the Open-Label Extension (OLE) Study, will be offered the opportunity to~     participate in the OLE trial.~   "
143328|NCT01691248|"~     The objective of this study is to demonstrate the efficacy and safety of Fidaxomicin versus~     placebo for prophylaxis against Clostridium difficile-Associated Diarrhea (CDAD) in adult~     participants undergoing hematopoietic stem cell transplantation (HSCT). The primary~     hypothesis is that Fidaxomicin is superior to placebo in preventing CDAD in participants~     undergoing HSCT.~   "
143308|NCT01691508|"~     This is a randomised, double-blind, placebo-controlled, parallel-group, multicenter study of~     mepolizumab in comparison with placebo in reducing Oral Corticosteroid (OCS) use in subjects~     with severe refractory asthma. The study consists of four phases, OCS Optimisation Phase~     (Week -8 to Week 0), and the double-blind treatment period divided into an Induction Phase~     (Week 0 to Week 4), OCS Reduction Phase (Week 5 upto Week 20) followed by Maintenance Phase~     (Week 20 to Week 24). During the Optimisation Phase the investigator will adjust the OCS~     (prednisone/prednisolone) dose according to the Optimisation titration schedule based on a~     review of Asthma Control Questionnaire (ACQ)-5 score and exacerbation. In the Induction Phase~     subjects will be randomized 1:1 (approximately 60 per arm) to receive either mepolizumab (100~     mg) administered subcutaneously (SC) or placebo every 4 weeks in addition to their existing~     maintenance asthma therapy with the lowest dose of OCS from Optimisation Phase. The Induction~     Phase will allow sufficient time for those subjects randomised to the mepolizumab arm to~     achieve a decrease in the eosinophilic inflammation prior to the reduction in OCS. During the~     Reduction Phase, subjects will continue receiving 100 mg mepolizumab/placebo every 4 weeks~     and the OCS dose reduction will be done every 4 weeks using the reduction titration schedule~     based on a review of eDiary parameters recorded by the subject, the subjects' exacerbation~     history, and a review of the signs and symptoms of adrenal insufficiency. In the Maintenance~     Phase subjects will be maintained without any further OCS dose adjustment. Subjects who~     complete the 24 week double-blind period and meet the eligibility criteria, will be offered~     the opportunity to participate in an open label extension (OLE) study otherwise they will~     return for a Follow-up Visit 12 weeks after their last dose of double blind study treatment.~     At each clinic visit, adverse events, safety labs, spirometery parameters and exacerbations~     will be assessed. The pharmacokinetic samples will be collected in the beginning of the~     treatment, prior to last dose, at the end of study (exit visit) and the follow up.~   "
143309|NCT01691495|"~     Fondaparinux is an anticoagulant used in the prevention and treatment of thromboembolic~     disease. It has recently been approved in the European Union (EU) for the treatment of~     patients with isolated superficial vein thrombosis (SVT), i.e. without concomitant deep vein~     thrombosis (DVT), of the lower limbs. As part of EU approval, GlaxoSmithKline (GSK) committed~     to evaluate physicians' adherence to fondaparinux prescribing information regarding proper~     diagnosis and dosing for the treatment of SVT.~      The primary objective is to evaluate physicians' adherence to fondaparinux prescribing~     information for the treatment of patients with SVT without concomitant DVT.~      The study is designed as a non-interventional, retrospective chart review of patients~     prescribed fondaparinux to treat their SVT. The study will be conducted in several EU~     countries.~      ARIXTRA® is a registered trademark of the GlaxoSmithKline group of companies.~   "
143310|NCT01691482|"~     The objective of this study is to assess the daily variation in bronchodilator response to an~     inhaled short acting beta2-agonist (albuterol/salbutamol) and an inhaled short acting~     anticholinergic (ipratropium) individually and when used in combination in subjects with~     COPD.~   "
143311|NCT01691469|"~     This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single~     dose, crossover, oral bioequivalence study.~   "
143312|NCT01691456|"~     This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single~     dose, crossover, oral bioequivalence study.~   "
143313|NCT01691443|"~     The objective of this study is to investigate the effect of vibration feedback on the~     gripping pressure in the territory of the median nerve.~   "
143314|NCT01691430|"~     Urinary tract infection (UTI) is the most common infection in nursing home residents, and~     bacteriuria is the greatest trigger for antimicrobial therapy in the nursing home setting.~     The primary aim of this study is to test the efficacy of two oral cranberry capsules per day~     in the reduction of bacteriuria plus pyuria in female nursing home residents. These aims will~     be accomplished by conducting a double blind randomized placebo controlled efficacy trial of~     two oral cranberry capsules daily versus placebo in a cohort of Connecticut female nursing~     home residents.~   "
143315|NCT01691417|"~     Based on the reversal of the adverse cardiovascular parameters during Laproscopic Surgery and~     its influence on cardiac activity in healthy subjects, the investigators expect to improved~     cardiac function in patients suffering from congestive heart failure.~   "
143316|NCT01691404|"~     Flavonoid-rich foods such as tea and cocoa have been identified as having a blood~     pressure-lowering effect. Part of this effect is thought to be due to the flavonoid content~     of these foods although it is currently unknown which flavonoids play a role. Epicatechin is~     one the major flavonoids in cocoa while quercetin is largely found in tea.~      During this study the investigators plan to investigate the effects of pure epicatechin and~     quercetin supplementation on vascular function and blood pressure in untreated~     (prehypertensive) subjects by way of a three-armed double-blind crossover intervention.~     Participants will sequentially consume supplements containing quercetin, epicatechin or~     placebo for a period of 4 weeks. Before and after this 4 week period, measurements of~     vascular function and blood pressure will be taken.~      The investigators hypothesize that the supplementation of epicatechin and quercetin will~     improve vascular function and blood pressure.~   "
143317|NCT01691391|"~     3rd line standard treatment of patients with metastatic colorectal cancer (CRC) harboring~     K-ras wild type consists of anti-EGFR treatment with either cetuximab or panitumumab. This~     type of treatment has a modest but significant beneficial activity in this patient group with~     improved progression-free and overall survival. Although it is well known that patients with~     advanced CRC harboring a K-Ras mutation will not respond to anti-EGFR treatment, it is not~     understood why patients with K-Ras wild type CRC do not all benefit from this type of~     therapy. In order to optimize treatment of these patients as well as health care costs, it is~     extremely important to identify those patients who will respond to treatment with an EGFR~     inhibitor at an early stage.~      The investigators hypothesize that the differences in response to treatment with cetuximab~     are due to variability in the pharmacokinetics and -dynamics of the antibody. Thus, the~     investigators hypothesize that patients who do not respond to anti-EGFR treatment, have~     insufficient drug levels in tumor tissue. The investigators hypothesize that this is due to~     pharmacodynamic processes such as sequestration of cetuximab in the liver which expresses~     high levels of EGF receptor.~      With the introduction of immuno-positron emission tomography (PET), an attractive novel~     option to visualize molecular interactions has been developed using the combination of PET~     with labeled mAbs. Cetuximab labeled with zirconium-89 (89Zr) has been successfully generated~     (GMP) and is available for this study. Previous studies have shown excellent stability of~     this compound and 89Zr is shown to be safe in humans. The investigators will use~     89Zr-cetuximab to demonstrate tumor targeting by imaging and explore the relation of uptake~     with treatment response. With this approach the investigators hope to achieve a better~     understanding of the mechanisms of action of this therapeutic mAb in metastasized CRC and~     eventually develop strategies that may improve efficacy of cetuximab treatment.~   "
143348|NCT01690988|"~     Delirium is a medical term or condition that includes a temporary inability to focus~     attention and to think clearly. Delirium occurs commonly (10% to 70%) in patients older than~     60 undergoing large surgeries. The purpose of this study is to test rigorously whether a drug~     called ketamine can decrease the chance that patients will experience delirium after their~     surgery. The investigators are also testing whether ketamine decreases postoperative pain,~     postoperative opioid consumption, postoperative nausea and vomiting, ICU and hospital length~     of stay, and adverse outcomes (e.g. hallucinations and nightmares).~   "
143318|NCT01691378|"~     The purpose of this project is to provide further evidence regarding a groundbreaking~     psychological treatment for suicide prevention in individuals with moderate to severe~     traumatic brain injury (TBI), Window to Hope (WtoH). The study will be one of the first five~     randomized clinical trials (RCTs) internationally to evaluate a psychological treatment for~     affective distress after TBI and the first conducted in the United States (U.S.) to~     specifically address suicide risk as an outcome.~      The current project aims to adapt WtoH for U.S. military personnel/Veterans (expert Consensus~     Conference, participant total up to 15), implement the intervention in a VAMC (Pilot Groups~     1-4, participant total up to 12), and replicate the results from the original trial in this~     novel context with a larger sample size (n=70 completed protocols [up to 90 recruited].~     Deliverables are expected to include an intervention suitable for both dissemination and~     larger Phase III trials.~   "
143319|NCT01691365|"~     Substantial evidence shows that diets incorporating antioxidants and B-group vitamins can~     offer significant protection against infections and cardiovascular disease (CVD) especially~     in diabetic patients. The proposed study will determine whether improvements in antioxidants~     and B-group vitamins in diabetic patients who are known to have a high risk of CVD will lead~     to a clinical benefit~   "
143320|NCT01691352|"~     Countless children undergo surgery annually for management of what clinicians consider to be~     a dirty wound. One frequently encountered example is the ostomy reversal. During this~     planned operation, the previously diverted small bowel or colon is reconnected with the~     distal intestine, restoring continuity. However, this procedure leaves an open wound on the~     anterior abdominal wall, creating a conundrum for the surgeon and raises the question: how~     should the wound be managed? In the investigators practice at CHOA, surgeons utilize both a~     wick and a non-wicked wound dressing. In this prospective randomized trial, we wish to~     evaluate these two dressings in children receiving an ostomy closure. The investigators~     hypothesis is that the incidence of wound infection after ostomy reversal is the same~     regardless of if a wick is placed or not.~   "
143321|NCT01691339|"~     The aim of this study is to evaluate the safety and immunogenicity of Fluzone vaccine (18~     years to <65 years of age and ≥ 65 years of age), Fluzone Intradermal vaccine (18 years to~     <65 years of age), and Fluzone High-Dose vaccine (≥ 65 years of age).~      Primary Objective:~        -  To describe the safety of the 2012 - 2013 formulation of Fluzone and Fluzone Intradermal~          vaccines in adults 18 to < 65 years of age and the safety of the 2012 - 2013 formulation~          of Fluzone and Fluzone High-Dose vaccines in adults ≥ 65 years of age.~      Observational Objectives:~        -  To describe the immunogenicity of the 2012 - 2013 formulation of Fluzone and Fluzone~          Intradermal vaccines in adults 18 to < 65 years of age and the immunogenicity of the~          2012 - 2013 formulation of Fluzone and Fluzone High-Dose vaccines in adults ≥ 65 years~          of age.~        -  To evaluate the compliance, in terms of immunogenicity, of each study vaccine (Fluzone,~          Fluzone Intradermal, and Fluzone High-Dose) in the applicable age group with the~          requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance~          (NfG) CPMP/BWP/214/96.~        -  To submit remaining available sera from subjects given Fluzone vaccine to the Center for~          Biologics Evaluation and Research (CBER) for further analysis by the World Health~          Organization (WHO), the Centers for Disease Control and Prevention (CDC), and the Food~          and Drug Administration (FDA) to support selection and recommendation of strains for~          subsequent years' influenza vaccines.~   "
143322|NCT01691326|"~     The aim of this clinical study is to demonstrate safety and immunogenicity of Fluzone~     vaccine.~      Objective:~        -  To describe the safety of the 2012-2013 formulation of Fluzone vaccine, administered in~          a 1- or 2-dose schedule, in accordance with Advisory Committee on Immunization Practices~          (ACIP) recommendations, in children 6 months to < 9 years of age.~      Observational Objectives:~        -  To describe the immunogenicity of the 2012-2013 formulation of Fluzone vaccine,~          administered in a 1- or 2-dose schedule in accordance with ACIP recommendations, in~          children 6 months to < 9 years of age.~        -  To submit remaining available sera from subjects to the Center for Biologics Evaluation~          and Research (CBER) for further analysis by the World Health Organization (WHO), the~          Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration~          (FDA) to support selection and recommendation of strains for subsequent years' influenza~          vaccines.~   "
143323|NCT01691313|"~     Evaluate the safety and efficacy of a single oral dose of vanoxerine compared to placebo, in~     a dose modification manner, on the conversion of symptomatic atrial fibrillation (a-fib) or~     flutter of recent onset to normal sinus rhythm.~   "
143324|NCT01691300|"~     Positron emission tomography combined with computed tomography using carbon-11 acetate (ACT~     PET/CT) may help detect lesions before treatment and evaluate response following therapy in~     patients with from multiple myeloma (MM). This study aimed to prospectively assess the~     clinical utility of ACT PET/CT in MM as compared to the commonly used~     F18-fluorodeoxyglucose(FDG).~   "
143325|NCT01691287|"~     Type 1 diabetes is the most common childhood disease. Treatment of diabetes requires personal~     checks of blood sugar levels, injecting insulin, changing eating habits and physical~     exercise, which requires a real change in the life of the child & adolescent and can cause~     significant damage to the quality of life as well.~      Compliance to treatment is a major challenge for all patients and mostly to adolescence,~     which often worsen their diabetes control at that age.~      The Michael Method is a unique, holistic program to develop and realize an individual's~     emotional, intellectual and behavioral potential, which is based on the belief that every~     human being can excel in every field they choose. The method was developed in 1988 by a~     multi-disciplinary team of professional academic in Israel. Today the Israeli education~     system implements the method in Junior High Schools and High Schools in diverse educational~     sectors. The program is taught at many other various frameworks: teachers' continuing~     education programs, colleges, programs run by the Ministries of Defense and Social Welfare,~     the National Insurance Institute, the National Electric Corporation and in many other public~     and private frameworks.~      The proposed study is aimed to assess whether the Michael Method can be used as a tool for~     improving metabolic control and quality of life among uncontrolled adolescence with type 1~     diabetes~   "
143326|NCT01691274|"~     The purpose of this study in healthy people is to investigate safety, toleration and time~     course of plasma concentration of PF-04895162, following multiple oral doses for 14 days. The~     preliminary effect of food on Pharmacokinetics (PK) after single oral dose of PF-04895162~     will also be investigated.~   "
143329|NCT01691235|"~     Subjects are being asked to participate in this study because they have genotype 1 Hepatitis~     C Virus (HCV) and will be taking the standard of care drugs pegylated interferon, ribavirin,~     and telaprevir as part of their routine care. The purpose of this study is to see if the~     SIMpill automated pill dispensing device can help subjects take their medications at the~     times the doctor has instructed them to take it.~      The SIMpill device is an automated pill dispensing device that records a time stamp each time~     the device is opened and a dose of medication is taken. Physicians can download this data and~     generate a precise account of when you have taken your medication. In addition, if a dose is~     missed, the SIMpill device can be set to automatically notify you by text message if a dose~     is overdue. The Simpill device is a new way to keep track of when you take your HCV~     medications and will also help remind you when you forget to take a dose. In addition, this~     information will help your doctors understand how taking medication on time effects the~     success of the therapy.~   "
143330|NCT01691222|"~     Percutaneous tracheostomy in Intensive care unit (ICU) is performed with the use of flexible~     fiberoptic bronchoscope inside the conventional single lumen endotracheal tube owned by the~     patients. This situation may lead to many disadvantages for ventilation and airway protection~     of critically ill patients during the procedures. The use of double lumen endotracheal tube~     dedicated to the percutaneous tracheostomies may:~        1. improve the ventilation of patients during the procedure,~        2. protect the posterior tracheal wall from damage related to the different step of~          tracheostomies,~        3. protect the lungs from blood and secretions coming down from the chosen site of~          tracheostomy.~      So the aim of this study is to evaluate the oxygenation, gas exchange, ventilation and~     complications of percutaneous tracheostomies performed in ICU with a dedicated double lumen~     endotracheal tube.~   "
143331|NCT01691209|"~     The study shall explore whether treatment of atopic dermatitis is equally effective with~     Phoenix medical device as compared to standard therapy (Hydrocortisone cream).~   "
143332|NCT01691196|"~     Our study addresses the following research question: What is the role of obesity in~     modulating inflammation and innate immune function, as well as the overall responsiveness of~     innate immune cells (such as macrophages, neutrophils, and other peripheral leukocytes) in~     patients undergoing peritoneal dialysis?~      The investigators hypothesize that obesity will lead to increased inflammation in patients~     undergoing peritoneal dialysis.~   "
143333|NCT01691183|"~     The purpose of this research study is to learn about the variability in proptosis~     measurements. Measurements will be recorded using the Hertel exophthalmometer. This~     noninvasive tool is an instrument designed to measure the forward protrusion of the eye and~     may be used normally during a general eye exam. This instrument provides a method of~     evaluating and recording the progression and regression of the prominence of an eye caused by~     disorders such as thyroid disease and tumors of the orbit.~   "
143334|NCT01691170|"~     The patellofemoral pain syndrome (PFPS) is defined as a painful complaint in the anterior~     aspect of the knee, although peripatellar pain and / or retropatellar are also common. In~     general, conservative treatment is the initial option of choice for patients with PFPS,~     however, the lack of a specific causal factor makes it difficult to choose the best treatment~     so early. This way, the purpose of this study is investigate the effects of the quadriceps~     femoris strengthening versus hamstring stretching in patients with pattellofemoral pain.~   "
143335|NCT01691157|"~     The purpose of this trial is to investigate the effectiveness of an evidence based exercise~     program for shoulder impingement. Approximately 1% of adults consult their General~     Practitioner (GP) with shoulder pain each year, making it the third most common reason for~     musculoskeletal GP consultations in the UK. A further 50% of these patients are diagnosed~     with subacromial impingement syndrome (SAIS) (shoulder impingement syndrome) and commonly~     referred for physiotherapy treatment. This trial aims to compare the effectiveness of an~     evidence based exercise protocol with usual physiotherapy care.~   "
143336|NCT01691144|"~     Follow-up of cancer patients accounts for a substantial part of outpatient activity, and~     alternative models of care are developing. In some countries, low-risk follow-up is already~     done in primary care, mainly in breast, and colorectal cancer. In this study the~     investigators will explore gynecological cancer patients about their expectations regarding~     their future follow-up plan. Further, the investigators will ask about the experience and~     satisfaction among patients who have already attended a follow-up programme for 2-3 years. In~     addition, the investigators will especially focus on the cooperation aspect between primary~     and secondary care. The investigators hypothesize that follow-up of selected gynecological~     cancer patients can be done by general practitioners.~   "
143337|NCT01691131|"~     Introduction: There is evidence that demonstrate the beneficial effects of pulmonary~     rehabilitation programs (PR) on symptoms, exercise capacity, muscle strength and quality of~     life in patients with Chronic obstructive pulmonary disease (COPD). The majority of the~     studies used high intensity endurance and strength exercise training on land. Exercise on~     water is an effective form of training that has been used for decades for rehabilitation in~     different chronic conditions. In addition, there are promising preliminary results on the~     literature regarding aquatic training in patients with COPD. However, several gaps remain.~      Aim: Compare the effects of two rehabilitation programs with 6 months of duration in patients~     with COPD on physical activity in daily life and balance: land versus water.~      Methods: The sample will consist of 36 patients with COPD diagnosed according to the GOLD~     criteria, 50 years old or more and clinically stable.~      Patients will be evaluated in 3 different moments: before the PR, after the PR and 6 months~     after the end of the PR (follow up). In addition to the assessment of physical activity in~     daily life and balance, the investigators will also evaluate pulmonary function, peripheral~     and respiratory muscle strength, body composition, maximal and submaximal exercise capacity,~     functional status and quality of life.~      Both groups (land or water) will be submitted for 3 sessions of exercise training per week,~     with 45 minutes of duration, during 6 months. The sessions of both groups include the same~     exercises sequence. Endurance exercise training will be performed on a bicycle and walking on~     land and strength training using free weights. Workload will be established according to the~     tests performance on assessment and progression will follow a predetermined schedule and~     adjusted according symptoms. On water the same approach will be followed.~      Expected results: the investigators expect improvement in terms of symptoms, exercise~     capacity, muscle strength, quality of life, functional status and physical activity in daily~     life at the end of the two training protocols. However, it is unclear whether one training~     protocol will be superior than the other. Due to the characteristics involved in the aquatic~     training, the investigators hypothesized that this type of training can result in better~     results on balance.~   "
143349|NCT01690975|"~     This is a single-center, randomized, third party blind, placebo controlled, dose escalation~     study of benzonatate following single dose administration. The primary oobjective is to~     assess the safety and tolerability of increasing oral doses of benzonatate following single~     dose administration in healthy male and female subjects.~   "
143460|NCT01689532|"~     The purpose of this study is to evaluate the safety and efficacy of sirukumab as a single~     therapy in Japanese patients with moderately to severely active rheumatoid arthritis (RA) who~     have not responded to treatment with methotrexate (MTX) or sulfasalazine (SSZ).~   "
143338|NCT01691118|"~     Approximately half of hypertensive patients have diastolic dysfunction and diastolic~     dysfunction is associated with development of congestive heart failure and increased~     mortality. Although diastolic heart failure associated with hypertension is a clinically~     significant problem, few clinical trials have been conducted and there is no proven~     pharmacological therapy to improve outcomes. To the best of the investigators knowledge,~     there has been no randomized trial to demonstrate that an antihypertensive drug improves~     diastolic function in hypertensive patients with diastolic dysfunction. The investigators~     hypothesize that fimasartan added to standard therapy will be superior to placebo in~     improving diastolic dysfunction in mildly symptomatic patients with hypertension and~     diastolic dysfunction, and try to examine this hypothesis in a double-blind, randomized~     comparison study using echocardiography.~   "
143339|NCT01691105|"~     This study will implement and test the effectiveness and cost-effectiveness of a tobacco~     cessation intervention (Academic Detailing + Integrated Tobacco Order Set - AD + ITOS) for~     adults admitted to the hospital. The intervention will begin during the hospital stay and~     continue after discharge. The intervention will use resources easily available to most acute~     care hospitals: computerized physician order entry, physician and nurse education, staff~     meetings for physicians, nurses and allied health professionals, online learning~     capabilities, faxing to primary care providers (PCPs), and the telephone counseling and~     support available from a state smokers' quitline (QL).~      The investigators hypothesize that the subjects in the intervention arm (AD + ITOS) will be~     more likely to achieve tobacco abstinence at 12 months post hospital stay than subjects in~     the control arm (Academic Detailing - AD). Tobacco abstinence will be assessed by self report~     and biochemical verification (exhaled carbon monoxide reading).~   "
143340|NCT01691092|"~     This study is designed to look at that involvement of a process in the brain called the~     glutamate system in depression. Participants will undergo a screening session, up to two~     functional Magnetic Resonance Imaging (fMRI) scans, and up to three Positron Emission~     Tomography (PET) scans, as well as cognitive testing at each scan session. For one of the PET~     scans, a drug (either ketamine or n-acetyl cysteine) will be administered.~      Hypothesis 1: The investigators hypothesize administration of ketamine or n-acetylcysteine~     (NAC) will lead to a decrease in mGluR5.~      Hypothesis 2: The investigators hypothesize an improvement in memory and attentional skills~     after drug challenge.~      Hypothesis 3: The investigators hypothesize an increase in mGluR5 availability and change in~     MRI measures post drug challenge as compared to baseline, signifying synaptogenesis.~      Hypothesis 4: We expect there should not be a significant difference in reduction in mGluR5~     availability due to differences in ABP688 radiotracer infusion.~   "
143341|NCT01691079|"~     This will be a double-blind placebo-controlled study in which we plan to study 40 competitive~     endurance athletes. We will conduct an exercise test to evaluate maximal oxygen uptake and 2~     exercise challenge tests to provoke EIA. Prior to the exercise challenge tests the athletes~     will randomly receive inhaled placebo or inhaled ipratropium bromide. We will compare the~     athletes' airway response to the exercise challenge with and without the active drug.~   "
143342|NCT01691066|"~     The purpose of this study aims to investigate the utility of Pivotal Response Treatment~     (PRT), a behaviorally derived intervention, to improve the quality and frequency of~     communication and social engagement of toddlers with siblings who have an autism spectrum~     disorder (SIBS - ASD) and who demonstrate developmental delays and impairments in social~     interaction between 12 and 15 months of age.~   "
143343|NCT01691053|"~     End stage renal disease (ESRD) patients exhibit an extraordinarily high annual mortality.~     Cardiovascular (CV) causes account for almost half of all-cause mortality. Increased left~     ventricular mass (LVM) is a common finding in ESRD patients on dialysis and is an independent~     predictor of survival. Yet, to date there is no established medical treatment to reduce CV~     morbidity and mortality in ESRD patients on hemodialysis. Blockade of aldosterone action by~     means of mineralocorticoid receptor antagonists (MRA) provides cardioprotection and improves~     outcome in heart failure patients. Furthermore, the MRA spironolactone has recently been~     shown to reduce LVM in patients with mild-to-moderate chronic kidney disease (CKD). The~     investigators here hypothesize that spironolactone treatment is cardioprotective by reducing~     LVM in ESRD patients on dialysis.~   "
143344|NCT01691040|"~     This study is conducted to determine the safety, tolerability, and efficacy of NOX-H94 in~     patients with anemia of chronic disease (ACD). Furthermore, this study is intended to provide~     data needed to correlate plasma concentrations of NOX-H94 with its efficacy and to choose the~     appropriate dose and dose schedule of subsequent efficacy studies.~      Some chronic diseases, e.g. tumors, inflammation, renal disease, are associated with high~     hepcidin concentrations in the blood. These hepcidin concentrations cause a reduction in iron~     concentrations in the blood and subsequently impair formation of red blood cells. Treatment~     with NOX-H94 is expected to inhibit this patho-mechanism by binding and inactivating~     hepcidin.~   "
143345|NCT01691027|"~     The research is aimed at developing and testing a new method of visual-motor rehabilitation~     of Veterans with macular degeneration by using inexpensive tablet computers at home.~   "
143346|NCT01691014|"~     The rationale for this study is to further explore if development of antibodies against TNF-α~     blocking agents is associated with reduced clinical effect/worsened clinical outcome. An~     important aspect of the study is to carry out an exploratory analysis of the immunogenicity~     of the 4 recommended TNF-α blockers in the treatment of RA in Denmark, using the same~     cell-based assay.~   "
143347|NCT01691001|"~     Although the aetiology of emergence agitation (EA) derives from multiple factors, it is a~     frequent side effect of sevoflurane anaesthesia in children. Dexmedetomidine, a potent~     selective α2-adrenergic agonist, can reduce the doses of hypnotics, opioids, analgesics, and~     anaesthetics that must be concomitantly administered. This study was conducted to assess the~     effect of dexmedetomidine infusion on sevoflurane requirements and recovery profiles with EA~     in children undergoing ambulatory surgery.~   "
143374|NCT01690650|"~     -  Due to the increased risk of brain damage, continuous monitoring of the cerebral~          oxygenation is interesting. The investigators will evaluate the capability of the INVOS~          Oximeter to detect induced changes in the cerebral regional saturation.~        -  The purpose of the study is to investigate our hypothesis that cerebral vasoconstriction~          after oxygen exposure is prolonged in preterm infants compared to term infants.~   "
143350|NCT01690962|"~     The purpose of this study is to assess whether, in individuals with diabetic neuropathy, a~     low-fat, vegan diet in combination with a vitamin B12 supplement improves pain, sensation and~     other subjective symptoms, more effectively than a vitamin B12 supplement with no diet~     changes. The principal measure is pain as measured by the following assessment tools:~     Michigan Neuropathy Screening Instrument, Norfolk Quality of Life Questionnaire, Neuropathy~     Impairment Score - Lower Limbs, Neuropathy Total Symptom Score, Neuropathy Pain Scale, McGill~     Pain Questionnaire and Global Impression Scale. The study duration is 20 weeks.~      This study also examines the effects of a low-fat, vegan diet on mood, using the Center for~     Epidemiologic Studies Depression Scale-Revised, and the Beck Depression Inventory.~   "
143351|NCT01690949|"~     This trial in healthy subjects will assess PUR118's effect on attenuating ozone induced~     airway inflammation. This trial will establish the tolerability of PUR118 in healthy normal~     volunteers.~   "
143352|NCT01690936|"~     Identifying snacks that do not contribute to positive energy balance is crucial in weight~     management. The satiating effects of almonds, coupled with their convenience and palatability~     make them a promising weight management aid. Therefore, this study aimed to examine the~     effects of almond consumption with meals versus snacks on outcomes such as appetite, energy~     intake, body weight, as well as blood glucose, insulin and lipid responses.~   "
143353|NCT01690923|"~     The aim of this evaluation is to test:~        1. Whether using nasal pillows at high pressures has comparable outcomes to nasal masks~        2. Patient mask type preferences at high pressures~   "
143354|NCT01690910|"~     This is a 10-week pilot study for a randomized non-blinded controlled clinical trial to~     assess whether use of the Rifton Gait Trainer will improve the incidence of mobilization of~     critically ill ventilator dependent patients in the intensive care units (ICUs) and improve~     important patient outcomes. The pilot study is designed to assess the feasibility and~     logistics of doing a study of this nature in the ICU; it will also provide the means to~     obtain estimates of outcome effect sizes, number of repeated measures, time between repeated~     measures, and intra-subject and intra-unit correlations, to be used for sample size~     calculations.~   "
143355|NCT01690897|"~     The purpose of this study is to determine whether an 8-session mindfulness-based intervention~     (MBCT group) is effective for women with low sexual interest/desire in reducing sexual~     distress, improving their sexual response, and increasing their mindful skills, compared to a~     support group.~   "
143356|NCT01690884|"~     The investigators are trying to determine if a single dose of Ticagrelor will increase~     delivery of intraarterially-infused adenosine into the forearm interstitium, consistent with~     adenosine reuptake blockade.~   "
143357|NCT01690871|"~     Study objectives:~      The primary objective is to determine the efficacy of BEZ235 on Objective Response Rate (best~     response on study) according to RECIST 1.1 criteria~      The secondary objectives are:~        -  To determine the progression free survival rate at 32 weeks in the included population~        -  To assess the duration of response among responders~        -  To evaluate time to response~        -  To evaluate the time to progression~        -  To assess the overall survival~        -  To evaluate safety and tolerability of BEZ235~      The exploratory objectives are:~        -  To identify molecular and genomic profiles of PEComas and their potential relationship~          to clinical outcome by analyzing PIK3CA, Ras, Raf, TSC, AKT and PTEN alteration in tumor~          samples (archival or fresh pre-treatment tumor biopsy) and PIK3CA in circulating DNA.~        -  To determine biomarkers relevant to BEZ235 activity by analyzing the expression of~          phosphoproteins p-AKT, p-S6, p-4EBP1 at screening and during treatment as well as~          biomarkers for the proliferation (Ki-67) and apoptosis (PARP) (only if fresh tissue~          (optional) is available).~      Study population:~      The patient population consists of patients 18 years old or older with progressive~     unresectable/advanced or metastatic malignant PEComas previously treated for~     unresectable/advanced/metastatic disease with 1 to 2 prior lines of chemotherapy. Patients~     must have adequate hematologic, renal, cardiac and hepatic functions and not be previously~     treated with a mTOR inhibitor.~      Number of patients:~      16 to 33 patients~      Overview of study design:~      This is a prospective, multicenter, open-label, single arm, two-stage phase II study to~     investigate the efficacy and tolerability of BEZ235 in patients with progressive metastatic~     or unresectable/advanced malignant PEComas. The patient should have received 1 or 2 prior~     lines of chemotherapy.~      BEZ235 will be administered until disease progression. Sixteen patients will be enrolled into~     Stage 1 and observed for at least 32 weeks at which time an interim analysis will be~     performed (plus eventually 4-5 weeks for confirmation of responses occurring on or closely~     before this cut-off date). If the number of patients with a response (CR or PR) is 2 or less,~     the trial will be stopped for futility. If 3 or more patients experience a response~     enrollment will continue up to 33 patients (Stage 2).~      An Independent Data Monitoring Committee (IDMC) will be constituted for reviewing the interim~     analysis.~   "
143358|NCT01690858|"~     The aim of the study is to assess the role of complement dysregulation and its impact on~     antiangiogenic factors (soluble Flt1 and endoglin) in patients with foetal losses.~   "
143359|NCT01690845|"~     Hypoxic hepatitis (HH) is reported to be the most frequent cause of elevated aminotransferase~     levels in hospital. Up to 10 % of critically ill patients develop HH during the course of~     their intensive care unit (ICU) stay. Occurrence of HH is a life threatening event and~     ICU-mortality is reported to be up to 60%. Early therapeutic intervention is of central~     prognostic importance in patients with HH to improve the hemodynamic impairment as early as~     possible, to reduce hyperammonemia and hepatic encephalopathy, to avoid progression of organ~     failure and to improve outcome. Studies reported that Molecular Adsorbent Recirculating~     System (MARS®) therapy improved the hemodynamic situation in patients with acute and acute on~     chronic liver failure. The study hypothesis is that MARS® therapy in critically ill patients~     with severe HH improves hepatic hemodynamics and function and consecutively the course of the~     disease. 40 patients with suffering of severe HH with aminotransferase levels > 40 times the~     upper limit of normal of more than 12 hours will be randomized 1:1 to MARS® therapy (n=20) or~     conventional therapy (n=20). 4 MARS®-sessions will be performed on three consecutive days,~     each for at least 12 hours. Treatment will be continued under special circumstances. The~     maximum duration of the treatment phase is 7 days. The primary endpoint is the difference of~     the indocyanine plasma disappearance rate at day 7. The expected duration of the study is 2~     years.~   "
143360|NCT01690832|"~     Patients with acute coronary syndromes (ACS) are at increased risk for acute kidney injury~     (AKI) when they undergo urgent/emergency coronary angiography.~      The optimal medical treatment for preventing the occurrence of contrast induced - acute~     kidney injury is still controversial.~      Fenoldopam mesylate is a dopamine A1 receptor agonist that augments renal plasma flow that~     has reduced the risk of radiocontrast dye nephropathy in some (but not all) preliminary~     studies.~      Neutrophil gelatinase-associated lipocalin (NGAL) is a new biomarker predictive for AKI~     already shown to be useful for earlier diagnosis of contrast induced nephropathy.~      The primary objective of this study is to to test the hypothesis that fenoldopam, in addition~     to standard treatment, reduce the occurrence of contrast induced - acute kidney injury in~     patients with acute coronary syndrome (ACS) undergoing urgent/emergency coronary angiography~     and/or percutaneous coronary intervention.~   "
143361|NCT01690819|"~     Acute respiratory distress syndrome (ARDS) occurs in almost 20% of patients with severe acute~     brain injury and is associated with increased morbidity and mortality. A massive increase in~     sympathetic activity and an increased production of proinflammatory cytokines released into~     the systemic circulation are the most important recognized mechanisms. Altered blood brain~     barrier after injury causes spillover of inflammatory mediators from the brain into the~     systemic circulation leading to peripheral organs damage. The adrenergic surge induces an~     increase in vascular hydrostatic pressure and lung capillary permeability, causing an~     alteration of alveolar capillary barrier with fluid accumulation, resulting in ARDS.~      The main goal of mechanical ventilation after acute brain injury are the maintenance of~     optimal oxygenation, and a tight control of carbon dioxide tension, although ventilatory~     settings to be used to obtain these targets, while avoiding secondary insults to the brain,~     are not clearly identified.~      Protective ventilatory strategy has been positively evaluated first in patients with ARDS,~     and then in those undergoing cardiopulmonary bypass or lung resection surgery, or in brain~     death organ donors, but data on the effect of protective mechanical ventilation on patients~     with acute brain injury are still lacking even if this is a population with recognized risk~     factors for ARDS.~      Therefore, the primary aim of this multi-center, prospective, randomized, controlled trial is~     to investigate whether a protective ventilatory strategy, in the early phase after severe~     acute brain injury, is associated with a lower incidence of ARDS, avoiding any further damage~     to the brain. Secondary aim is to evaluate if a protective ventilatory strategy is associated~     with reduced duration of mechanical ventilation, incidence of organ failure, intensive care~     unit length of stay, and lower concentrations of plasma inflammatory cytokines, without~     adversely affect in neurological outcome.~   "
143362|NCT01690806|"~     Recurrent laryngeal nerve dysfunction and hypoparathyroidism are well-recognized important~     complications of thyroid surgery. The duration of convalescence, after non complicated~     thyroid operation, may depend on several factors of which pain and fatigue are the most~     important. Nausea and vomiting occur mainly on the day of operation. Glucocorticoids are well~     known for their analgesic, anti-inflammatory, immune modulating and antiemetic effects. The~     investigators therefore undertook the present study to investigate whether preoperative~     dexamethasone could improve surgical outcome in patients undergoing thyroid surgery.~   "
143363|NCT01690793|"~     The investigators hypothesize that there is a statistically significant decrease of~     Natriuretic Hormone Peptides (NHPs) in subjects with asthma exacerbation compared to levels~     following treatment of an exacerbation of asthma.~   "
143364|NCT01690780|"~     Children 5-17 years of age who have sustained a non-operative distal forearm (radius and/or~     ulna) or clavicular fracture will be randomized to receive either ibuprofen or oral morphine~     as needed for pain relief for the first 24 hours following discharge from the emergency~     department. Pain will be assessed using the self-report Faces pain scale revised (FPS-R). We~     hypothesize that oral morphine will result in greater pain relief than ibuprofen.~   "
143365|NCT01690767|"~     Children 0-24 months of age requiring a urethral catheterization for urine collection will be~     randomized to receive either topical and intraurethral 2% lidocaine or standard of care to~     assess for the effectiveness of the former in minimizing pain during urethral~     catheterization. It is hypothesized that administration of 2% lidocaine gel both topically~     and intraurethrally will confer a greater degree of pain reduction compared to standard of~     care.~   "
143366|NCT01690754|"~     In this study, Interactive Research and Development (IRD) in Karachi, Pakistan is evaluating~     the impact of Interactive Reminders on drug compliance and treatment outcomes. Interactive~     Reminders is an interactive SMS reminder system to help patients remember to take their TB~     medication. In this system, patients receive daily SMS reminders for the duration of their~     treatment at a pre-specified time, reminding them to take their medication. Patients are~     asked to reply back to the system, either through SMS or a missed call, with the time they~     took their medicine that day. If a response is not received within two hours, a second~     reminder is sent. If a response is still not received in a further two hours, a third and~     final reminder for the day is sent. Non-responsive patients are followed up with phone calls~     and a list of non-responsive patients is shared with clinics based on the parameters of~     non-responsiveness that they specify.~      IRD seeks to determine the impact of this system on treatment outcomes and compliance to~     prescribed medication through administering a randomized control trial among newly diagnosed~     TB patients in Karachi, Pakistan.~   "
143367|NCT01690741|"~     This study will be the first to test the anti-cancer peptide Nerofe in humans. It will~     evaluate the safety, pharmacokinetic behavior, and pharmacodynamic and clinical effects of~     Nerofe given intravenously every other day to patients with advanced malignant disease.~   "
143368|NCT01690728|"~     The aim of this study is to increase our knowledge about the effect of physical activity in~     patients who have undergone gastric bypass surgery. The study will provide novel information~     in two areas. The main objective is to study the effect of physical activity on the weight~     loss and cardiovascular risk factors. This will be accomplished in a randomized clinical~     trial in patients, who are eligible for gastric bypass (GB). Patients will be randomized to~     six month of structured physical activity or standard postoperative counseling. The study~     will include an exhaustive panel of blood tests related to cardiovascular risk and the most~     extensive evaluation of structural and functional vascular test done in this patient group so~     far. In addition the study will provide information of the effect of bariatric surgery per se~     since both pre- and postoperative investigations are conducted. The study will learn us to~     what degree it is possible to motivate this group of patients to increased physical activity.~     All together this will enable us to improve the counseling of the patients undergoing GB.~   "
143369|NCT01690715|"~     A retrospective study based on analysis of medical records of patients with hepatocellular~     carcinoma treated at the Hospital Sírio-Libanês (Sao Paulo-Brazil) between 2001 and 2011 with~     diagnosis confirmed by imaging or histological specimen underwent surgical resection with~     curative intent. The study aims to determine the prognostic value of vascular complications~     related to cancer and to evaluate the survival rate of these patients, comparing the data~     with those reported in the literature.~   "
143370|NCT01690702|"~     two-armed trial to compare E-nP-C against tailored dtEC-dtD in patients with high risk early~     breast cancer~   "
143371|NCT01690689|"~     The purpose is to assess the safety profile and performance of a femoral resurfacing implant~     for localized chondral lesions.~   "
143372|NCT01690676|"~     Effect of apple polyphenols on FMD.~   "
143373|NCT01690663|"~     When used in conjunction with a local anesthetic, dexamethasone may prolong both the sensory~     and motor effects of high supraclavicular brachial plexus nerve block (SBP) in arthroscopic~     shoulder surgery. This study seeks to determine if there is a relationship between the~     duration of sensory and motor blockade in supraclavicular brachial plexus nerve blocks (SBP)~     when combined with increasing doses of dexamethasone.~   "
143473|NCT01689363|"~     This study is designed to evaluate the allergenicity of Amphadase® in healthy volunteers~     using an intradermal skin test.~   "
143375|NCT01690637|"~     This is a prospective, randomized, double-blind, placebo-controlled trial that will be~     conducted in tertiary care pediatric hospitals in El Salvador and Panama. The primary purpose~     of this study is to determine whether empiric oseltamivir phosphate treatment given at the~     time of hospital admission to children less than 10 years of age hospitalized with influenza~     can effectively reduce their illness severity. Additional objectives are to: 1) evaluate the~     tolerability of oseltamivir phosphate treatment, 2) evaluate the effect of oseltamivir~     treatment on viral clearance and development of oseltamivir-resistant influenza virus during~     and after treatment in children hospitalized with influenza, 3) estimate the direct and~     indirect costs of all-cause respiratory illness and influenza-associated respiratory illness~     requiring hospitalization, and 4) evaluate the effect of empiric oseltamivir treatment during~     the influenza season on these costs.~      The primary study hypothesis is that children with laboratory-confirmed influenza receiving~     empiric oseltamivir phosphate treatment initiated at the time of hospital admission will have~     a shorter duration of hospitalization and a shorter time to resolution of signs of severe~     respiratory illness compared to children receiving placebo. The secondary study hypotheses~     are that children with laboratory-confirmed influenza receiving oseltamivir phosphate~     treatment will have a reduction in the time to non-detectable influenza virus and influenza~     viral RNA and children with all-cause respiratory illness receiving oseltamivir phosphate~     will not be more likely to experience severe adverse events than children receiving placebo.~   "
143376|NCT01690624|"~     Patients with acute myeloid leukemia who experience a relapse after at least one prior~     regimen may be enrolled in this trial. In addition, acute myeloid leukemia patients who are~     in complete remission with high risk to relapse may be eligible for this trial. The trial~     will examine whether monotherapy with BI 836858 is safe and tolerable at escalating dose~     levels.~   "
143377|NCT01690611|"~     The goal of this research is to determine if real time visual feedback of body movements~     improves balance control more than walking on a treadmill alone. Individuals participating in~     this research study will be tested using a battery of clinical strength and balance~     assessments twice before a 4 week training period and once after the training period. The 4~     week training period will consist of 12 sessions walking on a treadmill. The experimental~     group will see real time visual feedback regarding their body movements, and the control~     group will not receive this visual feedback. Following the 4 week training each participant~     will again be tested using the battery of clinical strength and balance assessments.~   "
143378|NCT01690598|"~     The purpose of this study is to investigate the effect of combined topotecan and veliparib~     (ABT888) treatment in relapsed ovarian cancer with tumor progression and negative or unknown~     BRCA mutation status.~   "
143379|NCT01690585|"~     The upper and lower gastrointestinal bleeding, not related to portal hypertension, is a~     common disorder in the elderly. Indeed, in 1996, in a French study, the median age of~     patients hospitalized for upper gastrointestinal bleeding was 68. During the same period in~     the studies reported in English the median age was 71. If epidemiological data concerning~     lower gastrointestinal bleeding are rare, the average age of hospitalized patients varies~     from 63 to 77 depending on the study. Due to improvement in endoscopic haemostatic procedures~     and current resuscitation methods, gastrointestinal bleeding prognosis has greatly improved,~     whereas anaemia related to a bleeding episode remains a frequent complication of~     gastrointestinal bleeding in elderly patients.~      Among elderly patients over 65, the prevalence of anaemia varies from 8 to 44% depending on~     the criteria used and populations studied. The occurrence of a bleeding episode can either~     induce anaemia or exacerbate pre-existing anaemia. Physicians in charge of gastrointestinal~     bleeding are often unaware of anaemic consequences in the elderly patients which can often be~     serious. Various studies have shown that anaemia increases morbidity and mortality rates in~     the elderly. Life expectancy is independently significantly lower for anaemic patients over~     65, than for non-anaemic subjects. Anaemia is also a risk factor for the occurrence of~     cardiovascular and neurological complications, impairment in cognitive function and increased~     risk of falling.~      Iron deficiency and anaemia induced by bleeding episodes in patients over 65 hospitalized for~     upper or lower gastrointestinal bleeding should be corrected rapidly and effectively.~     Currently, the cost and risks of infection or cardiovascular-related complications of~     transfusions lead to limiting red blood cell transfusion with a goal average of 9 g/dL~     haemoglobin. It is also necessary to develop alternatives to massive transfusions. The~     correction of iron deficiency promotes erythropoiesis and can quickly correct anaemia.~      In clinical practice, the effectiveness of iron intake by the oral route is limited by the~     frequent occurrence of significant gastrointestinal side effects that limit patient~     compliance and limited absorption necessitating prolonged treatment to correct iron~     deficiency.~      The black colour of stools caused by taking oral iron supplements also makes it difficult to~     detect a possible recurrence of bleeding after hospitalization.~      The prescription of intravenous iron seems more suitable for a rapid and complete correction~     of iron deficiency after gastrointestinal bleeding. The main objective of our study is to~     evaluate efficacy of intravenous iron for the correction of anaemia, measured by haemoglobin~     at week 6 (W6) in patients aged over 65, after gastrointestinal bleeding. Secondary~     objectives were to assess the speed of anaemia correction, the tolerance of intravenous iron~     supplementation, the rate of re-hospitalization within 6 months after discharge and patients~     quality of life. This is a prospective multicenter randomized study versus placebo. After~     obtaining informed consent, all patients aged over 65 admitted with upper or lower~     gastrointestinal bleeding, with successful outcome, not related to portal hypertension,~     responsible for persistent anaemia (definition: Hb < 11 g / dL) after hospitalization will be~     included in the study. Patients will be treated for their bleeding event in the usual manner~     of each centre with target for transfusion of 9 g / dL haemoglobin. The absence of external~     bleeding and haematocrit and/or constant haemoglobin levels will be considered as the end of~     bleeding.~      Day 1 was arbitrarily defined as the day the patient left hospital. The protocol at Day - 1~     included: obtaining informed consent of the patient, determination of iron and ferritin blood~     levels and complete blood count. and randomization intravenous iron injection , (Ferinject)~     versus Placebo. Intravenous iron injection will be performed at Day 0. A complete blood count~     will be performed at week 6 and month 6. Patients will be reviewed in consultation at week 6~     and at month 6 to obtain related intercurrent events and assess their quality of life.~      The results of this study could lead to changes in the care of older patients hospitalized~     for gastrointestinal bleeding.~   "
143380|NCT01690572|"~     Earlier studies indicated that Percutaneous coronary intervention (PCI) may be problematic in~     diffuse small vessel disease especially of diabetic patients. High restenosis rates after~     balloon only procedures in small vessels occur due to negative constrictive vessel remodeling~     if DES (drug eluting stents) are not used and prolonged anti-platelet therapy is not~     indicated. The main hypothesis of the trial is that in analogy to DCB success in peripheral~     arterial disease (PAD), cellular toxicity of the drug paclitaxel eluting from a IN.PACT~     FalconTM DCB will prevent constrictive remodelling of small coronary vessel segments after~     dilatation. The IN.PACT FalconTM DCB is compared with plain old balloon angioplasty (POBA)~     using a Sprinter LegendTM balloon in small vessel coronary artery disease. A constrictive~     remodelling process will be measured by optical coherence tomography (OCT) at 9 months median~     F/U. This pilot trial is planned to be randomized 1:1 for DCB against POBA therapy.~   "
143381|NCT01690559|"~     This study is a post-marketing surveillance in Japan to investigate the safety especially~     focusing on injection site adverse events and efficacy in patients with Ciprofloxacin iv~     administration without dilution in the daily practice.It is a local prospective and~     observational study of patients who have received Ciproxan intravenously for sepsis,~     secondary skin infections followed by superficial burn, post-surgical or post-traumatic,~     pneumonia, peritonitis, cholecystitis, cholangitis, anthrax. A total of 500 patients are to~     be enrolled and assessed during the period of treatment with Ciproxan.~   "
143382|NCT01690546|"~     The purpose of this study is to evaluate a very low dose naltrexone-buprenorphine treatment~     to transfer opioid dependent individuals to extended release naltrexone injection (Vivitrol).~     The hypothesis is that patients will complete the transfer to Vivitrol successfully, finding~     the treatment acceptable and showing minimal withdrawal discomfort.~   "
143383|NCT01690533|"~     The objective of this study is to assess the efficacy and safety of Avelox Tablet 400 mg~     (hereinafter as Avelox) in treating secondary infection of chronic respiratory disease.It~     is a local prospective and observational study of patients who have received Avelox tablets~     for Laryngopharyngitis, Tonsillitis, Bronchitis acute, Pneumonia, Secondary infection in~     chronic respiratory diseases, Sinusitis. A total of 500 patients are to be enrolled and~     assessed during the period of treatment with Avelox.~   "
143384|NCT01690520|"~     This randomized phase II trial studies how well donor umbilical cord blood transplant with or~     without ex-vivo expanded cord blood progenitor cells works in treating patients with acute~     myeloid leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, or~     myelodysplastic syndromes. Giving chemotherapy and total-body irradiation before a donor~     umbilical cord blood transplant helps stop the growth of cancer cells. It may also stop the~     patient's immune system from rejecting the donor's cells. When the healthy stem cells and~     ex-vivo expanded cord blood progenitor cells are infused into the patient they may help the~     patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. It~     is not yet known whether giving donor umbilical cord blood transplant plus ex-vivo expanded~     cord blood progenitor cells is more effective than giving a donor umbilical cord blood~     transplant alone.~   "
143385|NCT01690507|"~     Demethylating agent decitabine enhances the immunogenicity of leukemia cells by inducing the~     expression of cancer testis antigens (CTAs),MHC class I and II molecules,costimulatory~     molecules and adhesion molecules. The leukemias cells treated by decitabine will become more~     sensitive to the following adoptive T cell therapy.~   "
143474|NCT01689350|"~     The purpose of this study is to compare the genotype-based personal prescription of~     cyclophosphamide with the traditional prescription.~   "
143386|NCT01690494|"~     This study is a randomized controlled trial (RCT) that will rigorously evaluate the~     implementation, effectiveness and cost-effectiveness of a couple-based integrated human~     immunodeficiency virus (HIV) and drug abuse prevention intervention (Connect II) with~     drug-involved male offenders charged with misdemeanors and their primary female sexual~     partners, implemented by frontline providers in Criminal Court, Community Court or probation~     (CCP) sites in NYC, compared to CCP standard treatment of care services (TAU). The primary~     outcomes are to reduce sexually transmitted infections (STIs) and increase condom use.~   "
143387|NCT01690481|"~     Simplified Brochure~      Neuropsychological Testing/Assessment is like games for the child. They are asked to complete~     the sequence, identify pictures, explain what is happening, etc. There is no personality~     testing involved. Part of the standard IQ testing is done but no IQ score is obtained. Age~     appropriate testing is done for each child.~      The MRI is an enclosed machine. We have the child sit in a simulator after the~     neuropsychological testing to see what it will be like, including the sounds, etc. You will~     be given a video about MRI testing to view as well. The staff that does this has been doing~     this for years in a wide variety of children, young, developmental delayed, etc. The staff~     does this WITHOUT sedation. Some children cannot sit still through the entire series. We need~     to get six, 10 minute scans. Children are allowed movement such as the need to wiggle their~     toes and move in between each scan.~      The Neuropsychological Testing can be scheduled in the late afternoons if it is more~     convenient for your family. This visit may take 3-4 hours. The MRI scanning can be scheduled~     after 5pm and may take up to 2 hours depending on the child's cooperation. You maybe asked to~     repeat the Neuropsychological Testing and MRI scanning 24 months later.~   "
143388|NCT01690468|"~     The main purpose of this study is to determine if Triciribine (TCN) and carboplatin are safe~     and tolerable when given together, and to determine if this combination of drugs can help~     people with recurrent ovarian cancer.~   "
143389|NCT01690455|"~     This observational, multi-center study will evaluate the efficacy and safety of Mircera~     (methoxy polyethylene glycol-epoetin beta) in renal anemia correction in dialysed patients in~     daily clinical practice. Patient will receive Mircera according to local summary of product~     characteristics. Data will be collected for 12 months.~   "
143390|NCT01690442|"~     The proposed study addresses a significant public health threat of HIV, HCV and other STIs~     among a very high risk population of active IDUs and their sexual partners in Kazakhstan a~     region that is experiencing one of the fastest rising HIV epidemics in the world. There is a~     race to develop and implement effective HIV preventive interventions for IDUs and their~     sexual partners to stem the spread of HIV, HCV and other STIs in Almaty, Shu and other~     Central Asian towns along drug trafficking routes. The proposed study will test the~     effectiveness of a couplesbased HIV/STI risk reduction intervention to decrease new cases of~     HIV and Hepatitis C (HCV) and incidence of sexually transmitted infections (STIs), as well as~     to reduce unsafe injection practices and increase condom use among injecting drug users~     (IDUs) and their heterosexual, intimate partners in Kazakhstan.~   "
143391|NCT01690429|"~     Photoplethysmography is an easy non-invasive method to detect the pulse wave amplitude (PWA)~     from a finger. This can be measured using the Somnocheck micro system. A pulse wave amplitude~     decrease (PWAD) is considered to be a marker for autonomic activation. Detecting the PWAD is~     a surrogate marker for waking reactions (arousal) which eventually will contribute to assess~     sleep disruption and resulting performance deterioration. Arousal and performance~     deterioration and its possible improvement under continuous positive airway pressure (CPAP)~     therapy will be determined in this study.~   "
143392|NCT01690416|"~     The aim of the project is to compare two methods for arterial cannulation. The traditional~     method with ultrasound guided cannulation. The investigators goal is to improve this~     procedure to reduce pain and complications.~   "
143393|NCT01690403|"~     Primary Objective:~      - To evaluate the effect of single and repeated administration of rifapentine given as daily~     or weekly regimen on steady-state pharmacokinetic parameters of efavirenz, emtricitabine and~     tenofovir given as a fixed dose combination (ATRIPLA™ ).~      Secondary Objective:~      - To evaluate the safety and tolerability of concomitant administration of rifapentine and~     ATRIPLA™ given to HIV+ patients~   "
143394|NCT01690390|"~     The primary purposes of this study are to assess the safety and efficacy of using high doses~     of the drug Icotinib (Conmana) as a way to treat patients with non-small cell lung cancer~     that achieve stable disease after 8 weeks routine therapy.~   "
143395|NCT01690377|"~     Dendritic cells (DCs) are the professional antigen-presenting cells of the immune system. As~     such they are currently used in clinical vaccination protocols in cancer patients, and both~     immunological and clinical responses have been observed. Several subsets of dendritic cells~     have been characterized in the peripheral blood. One such subset is referred to as~     plasmacytoid dendritic cells (PDC), another as myeloid dendritic cells (myDC). To date PDC~     and myDC have not been evaluated for their capability to induce anti-tumor immune responses~     in patients. For this reason the investigators will perform a safety and efficacy study with~     PDC and myDC in stage IV melanoma patients.~   "
143396|NCT01690364|"~     Recently intraoperative motor evoked potential monitoring (MEP) is widely used to reduce~     neural damage during neurosurgery.~      As neuromuscular blockade(NMB) during MEP monitoring decreases the amplitude of MEP, partial~     NMB is usually maintained during general anesthesia. Continuous infusion of NMB agent is~     preferred than bolus infusion during MEP monitoring. There are a lot of NMB agents in~     clinical use. But there have been no reports about the effect of changing NMB agent on~     efficacy of MEP monitoring.~      Therefore, the investigators performed a randomized controlled trial to evaluate the effect~     of changing NMB agent on the variability of MEP amplitude during neurosurgery.~   "
143397|NCT01690351|"~     The primary purpose of this study is to estimate the relative bioavailability and food effect~     of a PF-05089771 capsule.~   "
143398|NCT01690338|"~     The purpose of this study is to determine the incidence of residual curarization in PACU and~     relevant risk factors.~   "
143410|NCT01690182|"~     The GI MRI Research group at the University of Nottingham has been developing new,~     non-invasive magnetic resonance imaging (MRI) techniques to image the gastrointestinal tract.~     In collaboration with food manufacturer Unilever, the investigators want to image the abdomen~     of healthy volunteers after consumption of test meals of varying volume and energy density to~     determine levels of gastric distension and investigate possible correlations of this with the~     subjects' sense of satiety.~   "
143399|NCT01690325|"~     The GALADON trial is a diagnostic and interventional study in which different molecular~     imaging methods as Positon Emission Tomography (PET), different kind of Magnetic Resonance~     Imaging - methods (MRI, DWI and DCE-MRI) will be compared with common imaging methods~     (mammography, ultrasound) to see if there can detect an early response to a combined~     neoadjuvant therapy with bevacizumab and docetaxel in patients with locally advanced breast~     cancer. Neoadjuvant chemotherapy (this means patients were treated before the tumor was~     removed by surgery) with a drug like trastuzumab (monoclonal antibody) which is target to the~     Her2-protein is much more powerful than with chemotherapy alone because it is normalizing the~     blood supply and improves tumor delivery of conventional chemotherapy like docetaxel. The~     HER2 protein is only available in about 30 % of breast cancer types. bevacizumab is another~     humanized monoclonal antibody like trastuzumab but is effective not only in patients with an~     positive HER2 status and in combination with trastuzumab it may emphasize the effect in~     reduction of tumor growth. Bevacizumab is approved in advanced disease, but no major~     neoadjuvant data available so far for primary breast cancer. As the therapy with monoclonal~     antibody regimes are expensive and may cause severe side effects predictive factors to select~     patients who will benefit from such highly specific drugs before therapy start would be~     medically and economically highly valuable. In this study the efficacy of combined~     neoadjuvant chemotherapy with bevacizumab, trastuzumab and docetaxel in Arm A and bevacizumab~     and docetaxel in Arm B should be evaluated and the predictive impact of different imaging~     methods for tumor response should be shown.~   "
143400|NCT01690312|"~     The objective of this study is to determine the acute and chronic [4-week] effects of a~     high-DHA fish oil supplement on fasting and post-prandial (post-meal) biomarkers of~     cardiovascular disease risk, in adults on Statin therapy.~   "
143401|NCT01690299|"~     This study will test the clinical effectiveness and safety of apremilast compared with~     placebo as well as etanercept compared with placebo in the same group of patients with~     moderate to severe plaque psoriasis.~   "
143402|NCT01690286|"~     The purpose of this study is to evaluate the effects of repeated twice-daily administration~     of 200 mg ketoconazole on the steady-state pharmacokinetics of JNJ-38518168.~   "
143403|NCT01690273|"~     Mobility exercises are used in Ankylosing Spondylitis (AS) patients to preserve and restore~     axial mobility, but there are no data regarding a specific rehabilitation program that~     includes flexibility alone and its association with resistance exercises in AS patients with~     stable disease activity. So, we assessed the effects of two exercise programs in terms of~     mobility, functional capacity, quality of life and disease activity in AS patients. Methods.~     Fifty-five sedentary AS patients with a Bath Ankylosing Spondylitis Activity Index (BASDAI)~     <4 were included.~   "
143404|NCT01690260|"~     Results of growth factors indicate that Bone Morphogenetic Proteins (BMP) have an exceptional~     ability to stimulate different characteristics of mesenchymale cells to osseous cells. Local~     application of BMP results in an increase of osseous tissue regardless of the location of the~     growth factor.~      5 years clinical studies show that BMP's can stimulate an increase of osseous tissue and~     improve clinical results when autologous bone graft is reduced or removed.~      The purpose of this study is to examine whether recombinant growth factor BMP-2 can replace~     autologous bone graft in order to stimulating ossification during transplantation of osseous~     tissue.~   "
143405|NCT01690247|"~     Liver transplantation is the only lifesaving intervention for patients with end-stage liver~     diseases. Despite the ability of current immunosuppressive agents to reduce the incidence of~     acute rejection, the rate of acute rejection reaches to 20-50% after liver transplantation.~     Furthermore, the long-term toxicity associated with current regimens for liver transplant~     recipients now is increasingly being perceived as an unmet clinical need. Mesenchymal stem~     cells (MSC) appeared to be effective in regulating the invoked immune response in setting~     such as tissue injury, transplantation, and autoimmunity, and have been used successfully to~     treat graft versus host disease and show immune modulation function both in vitro and in vivo~     and may help in repairing damaged tissue(s). Here, we evaluate umbilical cord derived MSC~     (UC-MSC) as an alternative immunosuppressive agents for liver transplanted patients, and~     examine if UC-MSC could improve the recovery of liver function.~   "
143406|NCT01690234|"~     In Denmark the number of patients, sick listed for more than four weeks is increasing, and~     patients suffering from musculoskeletal disorders make one third of the total amount of~     long-term absenteeism. Compared to other diagnoses, patients suffering from musculoskeletal~     diseases, including low back pain, are less likely to return to work after a period of sick~     leave. It seems that a multidisciplinary intervention, including cooperation between the~     health sector, the social sector and in the work place, has a positive effect on days off~     work due to musculoskeletal disorders and particularly low back pain. The aim of this study~     is to evaluate the effect of a work oriented multidisciplinary intervention.~      A randomized controlled trial will include 770 patients with low back pain. The study~     population consists of patients, who are sick listed or at risk of sick leave due to LBP.~      The control group is treated with usual care in a team with participation of a~     physiotherapist, a chiropractor, a rheumatologist and a local employed social worker The~     Intervention group is treated with usual care and in addition intervention of a psychologist,~     an occupational physician, an ergonomist and a social worker from the local sickness benefit~     office. The treating physiotherapist will be the RTW-coordinator. Outcome will be reported at~     the end of treatment as well as 6 and 12 months follow up. The primary outcome is number of~     days of work. Secondary outcomes are disability, pain, and quality of life.~      This large RCT study is testing the effectiveness of a preventive intervention targeting~     patients on short term sick leave or at risk being sick listed because of low back pain. We~     have developed a novel multidisciplinary team structure using the treating physiotherapist as~     the return to work coordinator, and having the case manager from the sickness benefit office~     participating in team meetings.~   "
143407|NCT01690221|"~     The purpose of this study is to determine if the study drug, VEN307 (diltiazem hydrochloride~     cream) is safe and to see if it will help with treatment of pain associated with anal~     fissures.~   "
143408|NCT01690208|"~     This is a pilot translational study aiming to compare the effects of a multi-component care~     program with personalized drug regimen augmented by behavioural therapy with psychological~     support and peer influence, led by a diabetes specialist team on metabolic control,~     psychological health and behaviours in difficult-to-treat type 2 diabetic patients versus~     usual care.~      The study hypothesis is to evaluate a novel individualized, multicomponent care program to~     optimize glycemic control in difficult-to-treat type 2 diabetic patients.~   "
143409|NCT01690195|"~     This is a long term extension study to evaluate safety and tolerability of subjects who~     complete study M11-793 which is evaluating a new treatment for subjects with mild to moderate~     Alzheimer's disease on stable doses of acetylcholinesterase inhibitors.~   "
143411|NCT01690169|"~     This trial is conducted in Europe. The aim of the trial is to investigate safety,~     tolerability and pharmacokinetics (the exposure of the trial drug in the body) of single~     doses of NNC0113-0987 in healthy male subjects.~   "
143412|NCT01690156|"~     Ultrasound has been used to guide a needle to inject local anesthetics around nerves. This is~     usually done in the same plane as the ultrasound beam in America and is known as an in-plane~     technique. When done correctly, the entire needle is visualized on the ultrasound screen as~     it approaches the nerves which are also seen on the same screen the entire time. The~     ultrasound probe can be held perpendicular or parallel to the shoulders of the person~     performing the in-plane technique. Our hypothesis is that holding the ultrasound probe~     perpendicular to the shoulder is superior to holding the probe parallel to the shoulder~     during an in-plane ultrasound guided regional anesthesia technique.~   "
143413|NCT01690143|"~     This study is for patients that have multiple myeloma that has come back or relapsed and~     their condition indicates a procedure called an Autologous Hematopoietic Stem Cell~     Transplantation (AHSCT). AHSCT is a procedure when stem cells from bone marrow or blood are~     removed before high-dose chemotherapy. Afterwards, the removed stem cells are put back into~     the patient's body to form a new population of blood cells.~      The high-dose chemotherapy administered before the AHSCT is called Conditioning Therapy.~     The FDA has approved the use of the drug melphalan as a conditioning therapy. This research~     study will look at whether adding the study drug called carfilzomib will improve participant~     outcomes. Carfilzomib is considered investigational and is not approved by the FDA for the~     treatment of relapsed multiple myeloma.~      This study is divided into two phases.~      Phase I: Dose Escalation Phase:~      The main purpose of Part I of this study is to examine the safety of the study drug,~     carfilzomib, and determine the safest amount of the study drug that can be given to subjects~     who have multiple myeloma. Subjects on this study will receive different dose levels of the~     study drug. If you are one of the first three subjects to receive the study drug, it will be~     at what is called the 'starting dose' for the study which is the lowest dose that is expected~     to be tolerated based on prior research. After the first set of participants receive the~     study drug, the study doctor will review their health to see how they are tolerating the~     treatment. This will decide if the study drug dosage will be increased or decreased for the~     next set of subjects who join the study. It is anticipated that 12- 18 participants will~     enroll in the Phase I portion of this study.~      Phase II: Safety Confirmation Phase:~      Once the study doctor has discovered the highest possible dose of study drug that subjects~     can tolerate, up to 28 more subjects may be enrolled at that dose level. The main purpose of~     the Phase II portion of the study is look at how effective the combination of carfilzomib and~     melphalan when given before your stem cell transplantation is in treating multiple myeloma.~     This expansion phase will also include evaluation of two single agent carfilzomib maintenance~     therapy regimens for patients without disease progression at day 100.~   "
143414|NCT01690130|"~     The proposed study will measure the change of cortical excitability during nicotine craving~     and examine the effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on nicotine~     craving and cue-reactivity among adult regular smokers.~   "
143415|NCT01690117|"~     The purpose of the present study is to adapt, to implement and to evaluate an support program~     for family caregivers of patients suffering from Alzheimers`Disease (AD). The intervention~     was comprehensive developed and successful evaluated in the USA and is called Resources to~     Enhance Alzheimers´Caregiver Health -second step (REACH II). To test the effectiveness of~     this German adaptation of REACH II the present implementation study is designed as randomized~     and controlled trial. Primary outcome is reducing family caregiver burden.~   "
143416|NCT01690104|"~     We are investigating the effects of pregnane X receptor (PXR) activation on the regulation of~     blood pressure in healthy volunteers. Rifampicin (an antibiotic and also an efficient PXR~     activator) and placebo will be given for a week to volunteers and blood pressure is measured~     24 hours using an ambulatory blood pressure monitor. Blood pressure regulating hormones will~     be measured in blood. Our hypothesis is that PXR is involved in the regulation of blood~     pressure.~   "
143417|NCT01690091|"~     The aim of the study is to evaluate the effect of metformin on myocardial function, insulin~     resistance and selected metabolic markers in patients with type 2 diabetes and heart failure~     (HF+DM+) in a cross-over, randomized, placebo controlled trial.~      Hypothesis:~      Metformin treatment in HF+DM+ group will lead to better myocardial function and load~     tolerance in comparison to placebo. The degree of improvement will be linked to selected~     metabolic parameters.~   "
143418|NCT01690078|"~     The investigators hypothesize that a functional computational model that simulates the~     mechanical and aerodynamic behavior of the upper airway in children with Pierre Robin~     Sequence (PRS) and laryngeal lesions (e.g. subglottic stenosis or SGS) can be used as an~     effective diagnostic and treatment planning tool.~   "
143419|NCT01690065|"~     The current standard therapy in previously untreated adults with chronic phase (CP) of CML is~     imatinib and the result of long-term follow-up of IRIS study proves that imatinib for CML CP~     is reasonable therapy.(1, 2) However, some patients were initially diagnosed as advanced CML,~     accelerated phase (AP) or blastic phase (BP). Various chemotherapies were tried and were~     found that there were no highly effective chemotherapies for CML BP.(3-11) Imatinib in~     patients with these advanced CML is also disappointing because of low response rates as well~     as short response duration, and sudden transformation to BC is found even in initial CML CP~     patients. (12-17). Recent studies showed that nilotinib or dasatinib is better than imatinib~     in terms of rapid response and higher molecular response in newly diagnosed CML~     patients.(18-21) More potent bcr-abl suppression of nilotinib is supposed to be more active~     than imatinib even in patients with advanced CML. However, nilotinib in patients with~     imatinib-resistant or -intolerant CML BP showed low hematologic response and major~     cytogenetic response.(22, 23)~   "
143420|NCT01690052|"~     The main objectives were: 1) To determine the efficacy of both cevimeline and pilocarpine in~     the secretion of saliva in patients with xerostomia, and 2) To compare the side-effects~     between the treatment for xerostomia with cevimeline and with pilocarpine.~   "
143421|NCT01690039|"~     Purpose~        1. To compare the performance of the two currently employed urinary acidifications tests in~          stone formers, the furosemide/fludrocortisone and ammonium chloride loading test.~        2. To study the impact of polymorphisms in the genes ATP6V1B1, ATP6V0A4 and SLC4A1 on~          urinary acidification in stone formers.~   "
143422|NCT01690026|"~     This present multi-site investigation compares a voluntary brief intervention for adolescent~     alcohol problems to an educational comparison condition. Measures are taken at intake and at~     4 and 12 weeks post intake to determine effectiveness of the intervention to promote personal~     change efforts and arrest progression of alcohol problems. This study tests cognitive~     mechanisms of change and treatment characteristics and processes associated with youth~     self-regulation to reduce or stop hazardous drinking.~   "
143431|NCT01689909|"~     Epidemiologic reports have linked insomnia to suicidal ideation and suicide death. However,~     no studies have determined whether treating insomnia decreases the risk of suicidality. We~     have new data indicating that (1) the link between insomnia and suicidal ideation holds true~     in clinical trials of depressed insomniacs, (2) dysfunctional cognitions about sleep are~     related to suicidal ideas, and (3) treatment of insomnia with hypnotics leads to a reduction~     of suicidal ideation. We now propose to test whether cautious use of hypnotics in suicidal,~     depressed insomniacs may reduce suicide risk in a multi-site clinical trial.~   "
143423|NCT01690013|"~     Klinefelter syndrome is the most common sex-chromosome disorder in men with a prevalence of 1~     in 660 men. The syndrome is associated with hypogonadism. Many patients with Klinefelter~     syndrome have psychological complaints and physical discomfort. Some patients report a~     positive effect of testosterone treatment, whereas others do not.~      The aim of this study is:~      (i) To investigate quality of life in patients with Klinefelter syndrome. (ii) To investigate~     functional, physical and mental health in patients with Klinefelter syndrome.~      Questionnaire concerning mental and physical health and life quality are sent out to patients~     with KS and to age-, educational- and zipcode-matched men from the general population. The~     questionnaire include questions about housing, income, marital status, fatherhood,~     medication, chronic disease,school and education, attachment to the labor, sexual and~     erectile function, life quality, mental and physical health, satisfaction with life and~     symptoms of attention deficits hyperactivity disorders.~   "
143424|NCT01690000|"~     The aim of the study is to assess the effect of melatonin treatment in patients with~     osteopenia on BMD, muscle function, quality of life and calcium homeostasis.~   "
143425|NCT01689987|"~     This phase I trial studies the side effects and best dose of hydroxychloroquine when given~     together with cyclophosphamide, dexamethasone, and sirolimus in treating patients with~     multiple myeloma that has come back after a period of improvement or does not respond to~     treatment. Biological therapies, such as hydroxychloroquine, may stimulate the immune system~     in different ways and stop cancer cells from growing. Sirolimus may stop the growth of cancer~     cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy,~     such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of~     cancer cells, either by killing the cells, stopping them from dividing, or by stopping them~     from spreading. Giving hydroxychloroquine together with sirolimus, cyclophosphamide, and~     dexamethasone may be a better treatment for multiple myeloma.~   "
143426|NCT01689974|"~     An attractive area of research regards immune manipulations to recover some of the patient's~     immune response to his/her tumor, a strategy that has the advantages of being both natural~     and potentially long-lasting.[1] We propose to combine immunotherapy with radiotherapy~     directed to a metastatic site, to create a hub for in vivo immunization to the tumor, to~     enable tumor rejection at the other metastatic sites. This in vivo immunization is~     explored as a viable alternative to an individualized vaccine approach. Preclinical data~     generated by us and others support a proof of principle clinical trial that may open the~     field to an alternative use of radiotherapy in a novel partnership with cancer~     immunotherapy.[2]~   "
143427|NCT01689961|"~     Excess weight gain in pregnancy is a major problem affecting 55-75% of Canadian women who~     enter pregnancy overweight or obese and about 40% of women who are normal weight. Excess~     weight gain puts mothers at risk for health problems such as diabetes and developing or~     sustaining obesity after pregnancy, and puts their babies at risk of being born too large or~     developing related health problems. Mothers will be randomized to a structured high dairy~     protein diet and walking program or the usual care by their care provider. The investigators~     research questions are: Will a structured nutrition and exercise program in pregnancy~     compared to usual prenatal care increase the chance that mothers will achieve pregnancy~     weight gain within the current recommendations; improve health measures, in mother and infant~     at six months post-partum; to evaluate the benefits of a high dairy intake in pregnancy on~     maintenance of bone status in the mother and bone health outcomes in the child in early life~     (6 months); and to investigate the interactions between genes associated with bone health and~     high dairy diet supplementation on bone status in mothers during pregnancy, and bone health~     in mothers post-delivery and children to 6 months of age. Mothers' weight, physical activity~     and adherence to the nutrition plan will be assessed until birth and at follow-up with their~     infants at 6 months after birth. The research team will ensure new information is quickly~     transferred to programs to assist women to have healthier pregnancies.~   "
143428|NCT01689948|"~     Alzheimer's disease (AD) is the most common cause of dementia among elderly patients. By its~     prevalence and its medical and social consequences, AD represents a dual challenge to public~     health and society. The elderly want to stay in their homes even when their lives are altered~     by a chronic progressive disease. Their caregivers claim in turn a support at home. But this~     desire is questioned because of the characteristics of the disease, e.g. the altered~     relational function by the cognitive impairment and the behavioural disorders associated.~      Outpatients non-drug therapies represent a potential support that adapts to patient with an~     AD or mixed dementia, especially in their milder forms.~      The aim of the study is to evaluate the feasibility of a weekly rehabilitation's intervention~     at home and its acceptability by both the patient and the caregiver.~      The study of its efficiency in terms of autonomy will be the next step.~   "
143429|NCT01689935|"~     This research study aims to compare different methods for helping difficult to treat or~     scarring (cystic) acne, ALA-PDT and i-PDT.~      There is an investigational procedure called photodynamic therapy (ALA-PDT) that has been~     reported to be very efficient for acne treatment since 2000. Photodynamic therapy (PDT) uses~     a drug called ALA (aminolevulinic acid), which is marketed as Levulan®.~      Levulan® is applied directly to facial/back acne. This is the way that it is usually applied.~     Levulan® is left on the skin for three hours so the skin can absorb it. Next, the skin where~     the Levulan® was applied is exposed to a red light for activation.~      The sebaceous glands get obstructed and inflamed causing acne. ALA gets down under your skin~     through the skin pores to where the glands are. PDT destroys the glands reducing the acne~     lesion.~      Levulan® is absorbed by normal skin surrounding the oil glands. Therefore, this procedure~     also has some side effects. Some of the side effects include pain, burning sensation during~     the procedure, and redness, tenderness, and swelling after the procedure.~      At Massachusetts General Hospital's Wellman Center for Photomedicine, the investigators~     developed another procedure called inhibitory-PDT (i-PDT) that is similar to ALA-PDT. i-PDT~     is aimed at reducing the side-effects of ALA- PDT.~      The difference between these two procedures is that i-PDT uses a light source that will~     prevent Levulan® accumulation in the normal skin surface. The investigators would like to~     find out if Levulan® will be placed only inside the sebaceous glands.~   "
143430|NCT01689922|"~     The primary objective of this study is to compare the effectiveness of standard for our~     practice postoperative physical therapy (PT) program to a PT program that incorporates lower~     body positive pressure (LBPP) treadmill training for the patients after lumbar discectomy and~     fusion surgeries.~   "
143432|NCT01689896|"~     This research is being done to see whether testosterone replacement in men who take~     opioid-based pain medications and have low testosterone levels will show improvement in pain~     tolerance, pain perception and quality of life.~      Some men who take opioid-based medications (narcotics) for pain develop low testosterone~     levels. Research has shown that low testosterone levels may make a person more sensitive to~     pain. This means that if a person with a painful condition develops low testosterone level as~     a result of his pain medications, he might become more sensitive to pain and so may need~     higher doses of pain medications for pain control.~      Testosterone is a male hormone that is important for sperm production and the development of~     male characteristics such as muscle mass and strength, fat distribution, bone mass and sex~     drive. Testosterone hormone replacement therapy has been used for decades to treat men with~     low testosterone levels (male hypogonadism). Testosterone replacement therapies are available~     in the form of an injection into the muscle, implants under the skin, oral capsules taken by~     mouth, topical gels applied to the skin, and skin patches.~      This study will use Fortesta®, a topical testosterone gel (T-gel) absorbed into the skin.~     Fortesta® is currently on the market as an FDA-approved treatment of male hypogonadism (low~     testosterone levels).~      Men with non-cancer related pain who take opioid-based medications for pain and have low~     testosterone levels may join this study. (A low testosterone level is defined as early~     morning (before noon) blood testosterone level of 300 ng/dl or less, or a free testosterone~     of 50 ng/dl or less)).~   "
143433|NCT01689883|"~     The overall objective of the study is to test whether the use of small electrical currents to~     stimulate proprioceptors of the upper limb has potential for improving robot-assisted~     upper-limb rehabilitation in stroke survivors.~   "
143434|NCT01689870|"~     This is an open label, two-phase study combining a dose escalation Phase 1 with a~     proof-of-concept Phase 2 in patients with unresectable or metastatic melanoma, for whom~     treatment with ipilimumab is indicated.~      The purpose of the Phase 1 is to determine the Anti-OX40 Maximum Tolerated Dose (MTD) and the~     secondary objectives are anti-OX40 pharmacokinetics, biological activity and the tumor~     response assessed by the Immune-related Response Criteria.~      The purpose of Phase 2 is to determine tumor response (by irRC) and the secondary objectives~     are anti-OX40 pharmacokinetics, biological activity and Safety/Tolerability.~   "
143435|NCT01689857|"~     Compare the efficacy and safety of Scarclinic™Thin and Scarclinic™ Normal for the treatment~     of surgical scars.~      Participant: 40 Treatment period : 3 months Medical device: Scarclinic™Thin , Scarclinic™~     Normal Randomization: Table of random number~   "
143436|NCT01689844|"~     The Five Plus Nuts & Beans Study is a randomized, controlled trial to compare two strategies~     for translating the results of the DASH (Dietary Approaches to Stop Hypertension) Study into~     practice for 120 African American participants who are on stable doses of antihypertensive~     medications. The first arm of our study offers minimal DASH-oriented dietary advice along~     with a food credit at a local supermarket where they make their own decision of what to eat.~     The second arm consists of a single one-hour session with a nutrition expert who provides~     choices and places an on-line order from a community grocery store (Santoni's Market) with~     targeted purchases of fruits, vegetables, nuts and beans. Our primary outcome is change in~     blood pressure at 8 weeks. Secondary outcomes are effects on glucose, uric acid, urine~     potassium excretion, and self-report consumption of fruits and vegetables during the same~     period.~   "
143437|NCT01689831|"~     Dose comparison study of tuberculin purified protein derivative (PPD)Aplisol with the~     standard tuberculin purified derivative (PPD-S2).~   "
143438|NCT01689818|"~     Poor sleep quality has been recognized as a major public health concern in the world. The~     prevalence of insomnia in Taiwan is comparable to that of Western countries. It is estimated~     that up to 50% of elderly complain about their sleep. Insomnia is associated with anxiety,~     falls, or cognitive impairment in the elderly, which may compromise their daily activities~     function and quality of life.~      Recently, researches have demonstrated the associations between insomnia and endocrine system~     dysfunction, metabolic disorders, and cardiovascular events and death. Therefore, it is an~     important issue to improve sleep quality of the elders. The side-effects of pharmacological~     treatments and high-cost of cognitive behavior therapy limit their accessibility and~     effectiveness, and exercise training has been expected to provide an alternative intervention~     for insomnia. However, the long-term impact of insomnia on health-related fitness and~     metabolic function, and the effect of exercise training remain inconclusive. Therefore, the~     study hypothesis is that exercise training affect functional performance and quality of life~     in community-dwelling elderly with insomnia.~   "
143439|NCT01689805|"~     Atopic dermatitis is a common disease which affects about one million people in Finland at~     some stage of their life. In atopic dermatitis we see a superficial inflammation of the skin~     and a defect in skin barrier function. The filaggrin protein plays a central role in the skin~     barrier function and studies indicate that about 30% of patients with atopic dermatitis have~     a mutation in the filaggrin gene. The aim of the study is to investigate whether a mutation~     in the filaggrin gene affects the clinical treatment outcome in patients with atopic~     dermatitis. If a mutation predisposes to a worse response to treatment, this could be~     examined and those patients with the mutation could be given extra treatment support for~     their atopic dermatitis. The prevalence of filaggrin mutation in the Finnish non-atopic~     population is studied in the control group.~   "
143440|NCT01689792|"~     To compare the polyp and adenoma detection rate of MOVIPREP versus an oral Sodium~     Picosulfate/Magnesium Citrate solution.~   "
143441|NCT01689779|"~     A growing body of evidence suggests that robust postoperative immune function is associated~     with a lower risk of surgical site infections (SSIs). At the same time, vitamin D is~     increasingly recognized as a key regulator of the innate and adaptive immune systems. The~     investigators elected to conduct the current study in patients who will undergo colorectal~     surgery since these patients are historically at higher risk of developing SSIs and therefore~     would be ideal for future investigations.~   "
143442|NCT01689766|"~     Phase 2, multi-center, open-label, single-treatment group, baseline-controlled study to~     identify subjects with Folate Receptor-Positive Metastatic Renal Cell Carcinoma~   "
143443|NCT01689753|"~     The aim of the trial was to assess whether use of the TEGO connector was able to reduce the~     incidence of a composite endpoint of TCC-related dysfunction (TCC-D)or TCC-related bacteremia~     (TCC-B) in chronic hemodialysis (HD) patients carrying the TEGO® connector vs controls~     receiving trisodium citrate 46.7%.~   "
143444|NCT01689740|"~     This study will examine symptoms of posttraumatic stress disorder (PTSD) in people before and~     after psychotherapy with 25 mg followed two hours later by 12.5 mg or 125 mg followed two~     hours later by 62.5 mg methylenedioxymethamphetamine (MDMA) in order to see if this treatment~     is safe and can help reduce PTSD symptoms. Participants will be randomly assigned to one of~     the two doses of MDMA given in two sessions scheduled three to five weeks apart. They will~     prepare for the sessions before the first one and they will work with psychotherapists in~     conventional (non-drug assisted) psychotherapy afterwards. Symptoms of PTSD and depression,~     sleep quality and general psychological health will be measured at the start of the study and~     2 and 12 months after the second session.~   "
143445|NCT01689727|"~     Many types of cancers overexpress a receptor for the vitamin folate (Folate Receptor). This~     Phase 2 study will utilize a standard imaging radionuclide, technetium-99m, conjugated to a~     ligand (EC20) designed to bind to the folate receptor. The study is designed as an~     open-label, baseline-controlled study.~   "
143446|NCT01689714|"~     The folate receptor is overexpressed in many types of cancer, including ovarian and~     endometrial cancer, and the level of folate receptor expression increases with the stage of~     the disease. Technetium Tc 99m EC20 (99mTc-EC20; FolateScan), a folate-targeted diagnostic~     radiopharmaceutical, is designed to bind to the folate receptor. Thus, FolateScan may provide~     an effective method to determine folate receptor-positive (FR+) target tumors, thereby~     assisting in the identification of those patients who may benefit from folate-targeted~     therapy.~   "
143447|NCT01689701|"~     The investigators performed a double-blind parallel study in a group of Subjects Showing~     Erosive Gastritis who were given Hizikia Fusiformis Extract over a period of 4 weeks.~     Endoscopic observations were performed before and 4 weeks after the treatment, and the cure~     and improvement rates were investigated.~   "
143448|NCT01689688|"~     The purpose of this study is to evaluate serial changes of neointimal coverage after~     everolimus-eluting stent implantation at 3-, 6- and 12-months by OCT examination.~   "
143449|NCT01689675|"~     Musculoskeletal sprain/strain injuries and disorders (MSID) have a major impact on health,~     quality of life and societal productivity. Early intervention for pain following acute MSIDs~     may prevent secondary complications of chronic pain, disability, reduced quality of life or~     lost productivity. The investigators goal is to evaluate the efficacy of a computer-based~     self-management intervention for reducing pain and improving function in persons treated in~     on-site physical rehabilitation centers.~      The specific aims are:1) evaluate the efficacy of a computer-based self-management~     intervention in reducing pain and self-efficacy and function in high risk MSID patients; 2)~     determine long term impact during a six month follow-up period; and 3) determine whether~     reductions of pain and improved function translate into reductions in lost work time days~     away from work, restricted work days, worker's compensation costs and re-injury rates during~     the 6 month follow-up.~      Persons with sprain/strain injuries at risk for poor pain control will randomized to either:~     1) control condition - standard care in the rehabilitation center plus computer exposure or~     2) standard care plus computer-based self-management pain intervention. Assessment will be at~     baseline, treatment completion, 3 and 6 months. The primary outcome measures are~     self-efficacy, pain and physical/psychosocial functioning and secondary outcome measures are~     days away from work, restricted work days worker's compensation costs and re-injury rates.~     The investigation will also provide unique and valuable information regarding patients~     acceptance and use of computer-based interventions following acute injury. By establishing~     the utility and efficacy of computer-based pain management interventions for MSID the~     investigators have the potential to improve the health and quality of life of persons with~     injuries, improve productivity and develop new methods for health care delivery.~   "
143450|NCT01689662|"~     The folate receptor (FR) is overexpressed by many different cancer types, including renal~     cell carcinoma. Besides helping in the diagnosis of cancer, a folate-targeted imaging agent~     could provide an effective method to identify folate receptor-positive (FR+) cancer patients~     that may benefit from folate-targeted therapy. Up to 40 subjects, with known or strongly~     suspected metastatic renal cell carcinoma with at least one target lesion detected by a~     diagnostic imaging procedure (e.g. ultrasonography, CT, or MRI), will be enrolled in this~     study.~   "
143451|NCT01689649|"~     The purpose of this dose optimization study is to assess tolerability and efficacy of~     topiramate monotherapy in recently diagnosed patients with epilepsy who are treatment naive~     or have failed one anti-epileptic drug (AED) treatment in monotherapy.~   "
143452|NCT01689636|"~     Open-label, single-center, single-treatment group, baseline-controlled (for safety) study of~     the safety and biodistribution of Technetium Tc 99m EC20 in four normal subjects and four~     subjects with known or suspected ovarian cancer.~   "
143453|NCT01689623|"~     The purpose of this study is to evaluate effects of steady-state concentrations (constant~     concentration of medication in the blood) of TMC435 on the single dose pharmacokinetics (what~     the body does to the medication) of atorvastatin, the active metabolites ortho- and~     parahydroxylated atorvastatin, simvastatin and the active metabolite simvastatin acid. Plasma~     hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitory activity after a single~     dose of atorvastatin or simvastatin, either alone or in combination with TMC435 will be also~     evaluated.~   "
143454|NCT01689610|"~     The purpose of this non-interventional study is to collect data on the efficacy and safety of~     Nab-Paclitaxel in the routine application.~   "
143455|NCT01689597|"~     This pilot study intends to establish the efficacy of 2 different doses of epidural morphine~     for pain management after perineal trauma when using multimodal analgesia as well as the~     feasibility of conducting a larger randomized clinical trial. Women with traumatic vaginal~     delivery will be randomized into 3 groups with 10 patients each and receive 2.5 mg epidural~     morphine, 1.25 mg epidural morphine, or epidural saline. The primary outcome is total opioid~     consumption for breakthrough pain in the first 24 hours.~   "
143456|NCT01689584|"~     The aim of the COVAR project is to classify reliably a maximum of VUS of the French database~     in order to use them for the genetic counseling. The results obtained through this study will~     have a major impact on clinical management of the patients and their families conducting in~     some cases to propose a prophylactic surgery.~   "
143457|NCT01689571|"~     The study is designed to look at the safety, tolerability and efficacy of 2 different doses~     of the study drug (CHF6001, a PDE4 inhibitor) in asthmatics, when given by inhalation, once a~     day for 9 days. The efficacy will be evaluated by measuring the protective effect of CHF 6001~     after an allergen challenge.~   "
143458|NCT01689558|"~     1) Observe and compare the curative effect of endostatin/recombined Endostatin in alliance~     with neoadjuvant chemotherapy and Concurrent chemo-radio therapy to treat the local advanced~     nasopharyngeal darcinoma; 2) Evaluate the security and tolerability in endostatin/recombined~     Endostatin in alliance with neoadjuvant chemotherapy and Concurrent chemo-radio therapy to~     treat the local advanced nasopharyngeal darcinoma.~   "
143459|NCT01689545|"~     The purpose of this study is to determine whether a combined individual and structural level~     stigma reduction intervention is effective in reducing high risk injecting and sexual~     behaviors among HIV positive injecting drug users.~   "
143461|NCT01689519|"~     To evaluate the efficacy of vemurafenib in combination with cobimetinib (GDC-0973), compared~     with vemurafenib and placebo, in previously untreated BRAF V600 mutation-positive patients~     with unresectable locally advanced or metastatic melanoma, as measured by progression-free~     survival (PFS), assessed by the study site investigator.~   "
143462|NCT01689506|"~     This clinical study compares two fluid resuscitation treatments in patients suffering from~     burns injury. The treatments are Volulyte® and Human Serum Albumin (HSA) which will be~     administered as infusion solutions. It will be evaluated whether Volulyte® is effective and~     safe, and provides any benefit.~   "
143463|NCT01689493|"~     The purpose of this study is to assess the effectiveness of an adherence protocol~     intervention among stented patients to improve adherence to antiplatelet therapy (primary~     endpoint). Secondary endpoints will assess whether the intervention reduces cardiovascular~     events (ACS, stent thrombosis, re- hospitalization and coronary angiography,~     revascularization, all-cause mortality) and its cost-effectiveness.~   "
143464|NCT01689480|"~     It is now accepted that physical activity is not deleterious in myopathies, including~     muscular dystrophies. In patients suffering from facioscapulohumeral dystrophy (FSHD),~     aerobic training has been reported to be associated with physiological and functional~     positive effects without alteration in quality of life. Van der Kooi et al. (2005) and Cup et~     al. (2007) studies suggest that the combination of endurance and strength trainings is even~     more relevant. However, only a few controlled and randomized studies have been conducted on~     this topic and the impact of such training programs on skeletal muscle regenerative~     capacities has not been addressed yet. Moreover, due to the fact that training programs are~     mainly performed on short-term supervised periods, there is a lack of knowledge regarding~     long-term effects, patient's autonomy and whether or not practice of regular exercise can be~     maintained in patient's daily life. Also, only a few experiments report an integrative view~     of potential benefits of such programs on functional, biological and quality of life.~   "
143465|NCT01689467|"~     The investigators performed a 12-week, randomized, double-blind, placebo-controlled human~     trial to evaluate the efficacy and safety of Fermented Velvet Antler extract on fatigue~     recovery after exercise. The investigators measured fatigue recovery parameters , including~     lactate, ammonia, inorganic phosphorus, creatine kinase and LDH, and monitored their blood~     pressure.~   "
143466|NCT01689454|"~     Recently, it has been suggested that culture of embryos in EmbryoGen medium can increase the~     live birth rate in IVF patients with a previous history of pregnancy loss.~      Couples requiring IVF treatment and with a past experience of implantation failure will be~     included in the study.~      Controlled ovarian stimulation protocol will consist of an agonist down regulation and~     follicular stimulation by recombinant FSH. Fertilization will be achieved by standard IVF or~     intracytoplasmic sperm injection. Fertilized eggs will be cultured in 6% CO2, 5% O2, 89% N2~     atmosphere in microdrops. In the treatment group EmbryoGen culture medium (EG, Origio, Måløv,~     Denmark) will be adopted throughout the culture period. In the control group, inseminated~     oocytes will be cultured in standard culture conditions, i.e. IMS1 medium (ISM1, Origio,~     Måløv, Denmark), maintaining unchanged all other culture conditions.~      Procedures of embryo transfer, will be carried out on day 2 using EmbryoGen or ISM1~     respectively. The endometrial support will be the same in the two groups.~   "
143467|NCT01689441|"~     Observational studies among critically ill patients have shown strong associations between~     vitamin D deficiency and adverse outcomes, including increased length of stay, infection, and~     mortality. It is unknown whether vitamin D deficiency contributes directly to adverse~     outcomes or whether it is simply a biomarker of severity of illness or overall health status.~     However, vitamin D plays a key role in host defense, largely by stimulating production of the~     anti-microbial peptide cathelicidin (LL-37). We will test the hypothesis that administration~     of activated vitamin D (calcitriol) will increase serum levels of cathelicidin.~   "
143468|NCT01689428|"~     Recently, it has been suggested that culture of embryos in EmbryoGen medium can increase the~     live birth rate in IVF patients with a previous history of pregnancy loss.~      Couples requiring IVF treatment and with a past experience of miscarriage and/or biochemical~     pregnancy will be included in the study.~      Controlled ovarian stimulation protocol will consist of an agonist down regulation and~     follicular stimulation by recombinant FSH. Fertilization will be achieved by standard IVF or~     intracytoplasmic sperm injection. Fertilized eggs will be cultured in 6% CO2, 5% O2, 89% N2~     atmosphere in microdrops. In the treatment group EmbryoGen culture medium (EG, Origio, Måløv,~     Denmark) will be adopted throughout the culture period. In the control group, inseminated~     oocytes will be cultured in standard culture conditions, i.e. IMS1 medium (ISM1, Origio,~     Måløv, Denmark), maintaining unchanged all other culture conditions.~      Procedures of embryo transfer, will be carried out on day 2 using EmbryoGen or ISM1~     respectively. The endometrial support will be the same in the two groups.~      The investigators will consider ongoing clinical pregnancy as the primary outcome assuming a~     25% of increment in ongoing clinical pregnancy rate in the group with EmbryoGen medium. As~     secondary outcome the investigators will assume a 5% of increment in ongoing implantation~     rate after 12 weeks in the group with EmbryoGen medium.~   "
143469|NCT01689415|"~     It is known, that hypertension is the major risk factor of stroke and recurrent stroke. Blood~     pressure reduction - together with antithrombotics - remain crucial in stroke prevention.~      This pilot study will examine the effect of renal nerve denervation in patients with~     treatment resistant hypertension after ischemic stroke or DWI/DTI-verified stroke. With 24~     hours blood pressure measurements the effect after renal nerve denervation is examined 1,3,6~     and 12 months after the procedure.~   "
143470|NCT01689402|"~     What happens in the borderzone of a cerebral hemorrhage remains widely onknown and furhter~     the best timing for doing MR to look for vascular pathology in cerebral hemorrhage has not~     yet been determined. In this study we do acute MRS, a non-invasive imaging mathod to detemine~     the biochemsty in the border zone and structural MRI for vascular malformation. We repeat~     structural MRI after 8 weeks.~   "
143471|NCT01689389|"~     The aim of the study is to describe patient characteristics (demographic and clinical) and~     the patterns of use of Quetiapine XR in patients receiving the drug for the first time in~     real-life practice regardless the final diagnosis.~   "
143472|NCT01689376|"~     The purpose of this Managed Access Program is to provide regorafenib to patients diagnosed~     with metastatic and / or unresectable GIST who have progressed after standard therapy.~   "
143475|NCT01689337|"~     This is a Phase 2, double-blind, multicenter, randomized, placebo-controlled trial to~     evaluate the efficacy and safety of Sprifermin (AS902330) (recombinant human fibroblast~     growth factor-18 [rhFGF-18]) as an adjunct treatment to subjects following microfracture~     (MFx) surgery for cartilage injury of the knee.~      Primary Objectives~        -  To evaluate the effect of Sprifermin (AS902330) intra-articular knee injections as~          adjunct to microfracture (MFx) surgery on the composition of the refilled cartilage in~          the target knee, as measured by gadolinium-enhanced magnetic resonance imaging (MRI) of~          cartilage (dGEMRIC) time constant 1 (T1) relaxation time at 6 months after MFx surgery~        -  To evaluate the safety profile of Sprifermin (AS902330) when administered~          intra-articular into the knee as adjunct to MFx surgery in subjects with cartilage~          injury of the knee~      Secondary Objectives~        -  To further support the efficacy and safety of Sprifermin (AS902330) as an adjunct to MFx~          for cartilage injury repair through symptomatic outcomes and quantitative MRI~          measurement~   "
143476|NCT01689324|"~     This study is designed to assess the immunogenicity and safety of tetanus toxoid, reduced~     diphtheria toxoid and acellular pertussis vaccine (ADACEL®, Tdap vaccine) as a booster dose~     in adolescents in Japan.~      Primary Objective:~        -  To assess the immunogenicity of Tdap (SP306) when administered as a single dose in~          Japanese adolescents~      Secondary Objective:~        -  To assess the safety of Tdap vaccine when administered as a single dose in Japanese~          adolescents.~   "
143477|NCT01689311|"~     The purpose of this study is to compare the ability of an isolated sample of uterine muscle~     tissue (in a tissue bath) to contract in the presence of various drugs. The drugs~     studied--uterotonics--are typically used to contract the uterus when a pregnant patient~     continues to bleed after delivery. Amongst common uterotonic drugs, namely oxytocin,~     ergonovine, prostaglandin F2alpha, and misoprostol, the most effective one to use is unknown.~      The investigators will be testing isolated uterine muscle samples to increasing~     concentrations of these four drugs in three patient populations: non-laboring, laboring~     without exogenous oxytocin augmentation, and laboring with oxytocin augmentation. Contractile~     measures will be measured and compared between all groups. The investigators hypothesize that~     oxytocin alone will have a weaker uterotonic effect in oxytocin-augmented laboring patients,~     and all four drugs will induce different patterns of contractions.~   "
143478|NCT01689298|"~     The purpose of this study is to compare the ability of an isolated sample of uterine muscle~     tissue (in a tissue bath) to contract in the presence of various drugs. The drugs~     studied--uterotonics--are typically used to contract the uterus when a pregnant patient~     continues to bleed after delivery. Oxytocin is an old standard, but seems to suffer from a~     desensitization phenomenon. Carbetocin, a similar drug, has recently been suggested to~     clinicians as a replacement for oxytocin directly after certain types of Cesarean section.~      The investigators will be testing isolated uterine muscle samples after pre-treatment with~     oxytocin OR nothing (control) to increasing concentrations of oxytocin OR carbetocin.~     Contractile measures will be measured and compared between all groups. The investigators~     hypothesize that oxytocin pre-treatment will reduce contractions in both oxytocin- and~     carbetocin-induced contractions, and oxytocin and carbetocin will induce different patterns~     of contractions.~   "
143479|NCT01689285|"~     A new paediatric formulation (oral liquid) has been developed for flexible and accurate~     dosing of valacyclovir in children. To establish the bioavailability of this new formulation,~     healthy volunteers will be exposed to the new formulation and to valacyclovir tablets. The~     concentration of valacyclovir in their blood after exposure to the oral liquid will be~     measured and compared to the tablet.~   "
143480|NCT01689272|"~     The purpose of the study:~        -  To estimate the role of morphological, clinical, biochemical and imaging studies at~          stages of kidney transplantation (medical therapy, explantation, preservation,~          transplantation).~        -  To improve the ways of preserving optimal functional parameters of renal transplants.~   "
143481|NCT01689259|"~     Very low dose (VLD) cyclobenzaprine at bedtime has shown promise as a treatment for~     fibromyalgia, but the chemistry of cyclobenzaprine requires new formulation technology for~     bedtime use. The present trial is designed to assess the safety and tolerability of TNX-102~     2.4 mg SL Tablets (a new formulation of cyclobenzaprine designed to result in increased~     dosage precision and decreased potential for morning grogginess) at 2.4 mg and 4.8 mg and to~     compare the bio-availability of TNX-102 2.4 mg SL Tablets at 2.4 mg and 4.8 mg to that of~     TNX-102-A 2.4 mg SL Tablets (without phosphate) at 2.4 mg and cyclobenzaprine (5 mg tablets).~   "
143482|NCT01689246|"~     The purpose of this study is to determine the safety and efficacy of TRx0237 in the treatment~     of subjects with mild to moderate Alzheimer's Disease.~   "
143483|NCT01689233|"~     The purpose of this study is to determine the safety and efficacy of TRx0237 in the treatment~     of subjects with mild Alzheimer's Disease.~   "
143484|NCT01689220|"~     The purpose of this study is to evaluate the safety and tolerability of SP-02L monotherapy in~     Korean patients with relapsed or refractory Peripheral T-cell Lymphoma (PTCL).~   "
143485|NCT01689207|"~     This is a randomised, double-blind, 3-part study designed to investigate the safety and~     tolerability of ATM-AVI. The study aims to characterise the pharmacokinetics of ATM-AVI, when~     both drugs are administered alone (ATM or AVI) and in combination (ATM-AVI), following single~     administration, and following multiple administrations of ATM-AVI in healthy male and female~     (females of nonchildbearing potential) volunteers both young and elderly.~   "
143486|NCT01689194|"~     This clinical trial is Phase II trial for evaluating efficacy of induction chemotherapy using~     Genexol-PM + cisplatin for locally advanced head and neck cancer. The investigators try to~     evaluate response rate of Genexol-PM + cisplatin chemotherapy, and safety profile.~   "
143513|NCT01688843|"~     The objective of this study is to gather data to establish the safety, performance and~     effectiveness of the INGEVITY pace/ sense leads.~   "
143514|NCT01688830|"~     The primary objective is to investigate the safety, tolerability and pharmacokinetics of BI~     655075 following intravenous administration of single rising doses of BI 655075 when~     administered alone and after administration of dabigatran.~   "
143515|NCT01688817|"~     The purpose of this study is to assess the impact of physician's counseling on participation~     and utilization of sedation in a primary colonoscopy-based colorectal cancer (CRC) screening~     program~   "
143487|NCT01689181|"~     Apathy, defined as a quantitative reduction of voluntary, goal-directed behaviours (GDB), is~     a core component of negative symptoms. It has been suggested that the physiopathology of~     apathy is not a single entity but may be multiple, depending on which specific process or~     macrofunction is disrupted during completion of GDB. In line with this notion, Levy and~     Dubois proposed dividing apathic syndromes into three subtypes of disrupted processing:~     'a-motivation', 'cognitive inertia', and 'uncoupling'. In schizophrenia, apathy has been~     associated with executive dysfunction, functional impairment and poor outcome. However, the~     neurobiological underpinnings of apathy in schizophrenia are poorly understood.~      Primary objective: confirm that chronic schizophrenic patients are apathic compared to~     healthy volunteers~      Secondary objectives:~        -  investigate if apathy is related to a particular aspect of the disease (i.e. negative,~          positive symptomatology and/or deficit form)~        -  investigate if apathy correlates with executive dysfunction~        -  investigate if apathy is associated with a specific mechanism using an experimental task~          specially designed to investigate the different mechanism (i.e. 'a-motivation',~          'cognitive inertia', and 'uncoupling')~        -  investigate if there is a volumetric abnormality affecting the executive system in~          apathic schizophrenic patients~        -  link these eventual volumetric abnormalities to prefrontal cortex-basal ganglia circuits~          according to a specific subtype of apathy in the apathic schizophrenic group~   "
143488|NCT01689168|"~     Tobacco use is the number one killer of Americans today. Most current smokers have tried and~     failed to quit at least once. Smokers are addicted to the nicotine in tobacco products, and~     withdrawal from smoking can lead to physical symptoms such as irritability, anxiety,~     nervousness, depression and insomnia.~      This study will examine the effects of tobacco cessation counseling and chiropractic~     treatments on smokers who desire to quit.~   "
143489|NCT01689155|"~     This is a passive-surveillance study that will accrue subjects for surveillance. For each~     accrued subject, surveillance for outcomes will continue for six months following the first~     dose. If a second dose is given within that time, then surveillance will be continued for six~     months following the second dose.~      Observational Objective:~        -  To describe and characterize adverse events occurring after vaccination with Menactra~          vaccine.~   "
143490|NCT01689142|"~     Primary Objective:~      To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of~     change of HbA1c from baseline to endpoint (scheduled at month 6 [week 26]) in japanese~     patients with type 2 diabetes mellitus.~      Secondary Objectives:~      To compare a new formulation of insulin glargine and Lantus in terms of change in fasting~     plasma glucose (FPG), preinjection plasma glucose, 8-point self-measured plasma glucose~     (SMPG) profile.~      To compare a new formulation of insulin glargine and Lantus in terms of occurrence of~     hypoglycemia~   "
143491|NCT01689129|"~     Primary Objective:~      To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of~     change of HbA1c from baseline to endpoint (scheduled at month 6 [week 26]) in japanese~     patients with type 1 diabetes mellitus~      Secondary Objectives:~      To compare a new formulation of insulin glargine and Lantus in terms of change in fasting~     plasma glucose (FPG), preinjection plasma glucose, 8-point self-measured plasma glucose~     (SMPG) profile.~      To compare a new formulation of insulin glargine and Lantus in terms of occurrence of~     hypoglycemia~   "
143492|NCT01689116|"~     This is a single-center, multiple-dose, randomized, double-blind, double-dummy,~     placebo-controlled, active-comparator, parallel study in healthy volunteers.~   "
143493|NCT01689103|"~     This project is studying the role of the therapeutic alliance between the therapist and~     patient in the outpatient treatment of persons with alcohol use disorders.~   "
143494|NCT01689090|"~     The primary objective is to study if an inhibition of nitric oxide and/or prostaglandins~     affect the diameter changes of retinal vessels observed during hypoxia. Diameter changes are~     studied using the Dynamic Vessel Analyzer.~   "
143495|NCT01689077|"~     The purpose of this study is to determine if 48 hours of mild therapeutic hypothermia~     following out of hospital cardiac arrest gives a better cerebral outcome compared to 24 hours~     therapeutic hypothermia.~   "
143496|NCT01689064|"~     The purpose of this study is to determine if there is a significant difference in sinonasal~     disease specific quality of life and utility scores between patients undergoing the posterior~     septectomy or Stamm approach during endoscopic pituitary adenoma resection.~   "
143497|NCT01689051|"~     Diabetes and high blood pressure are risk factors for developing heart disease. An increase~     in the number of diabetes patients is expected. This increases the number of patients with~     heart disease, and since the vast majority with diabetes die from heart disease, it is~     extremely important to investigate how these diseases can be prevented and treated.~      Studies in animals have shown that intestinal hormone glucagon-like peptide-1 (GLP-1) can~     expand blood vessels, thus lowering blood pressure, but it is not known whether the effects~     is found in humans, which we will investigate.~      Studies have also shown that GLP-1 lowers blood sugar, but it is unclear whether this is~     solely due to increased insulin production, weight loss associated with GLP-1 intake or GLP-1~     has an effect on the muscles which increases the uptake of sugar. We investigate whether~     GLP-1 enhances the absorption of sugar in the leg.~      The investigators also examines whether these effects are greater in people with diabetes~     then in healthy.~   "
143498|NCT01689038|"~     Assess the binding rate of F17464 to cerebral receptors in healthy volunteers.~   "
143499|NCT01689025|"~     This trial is conducted in Europe and the United States of America (USA). The aim of the~     trial is to investigate the safety and tolerability of NNC0114-0006 in subjects with systemic~     lupus erythematosus (SLE) concomitantly treated with stable background therapies.~   "
143500|NCT01689012|"~     This study seeks to evaluate the effects of facial exercises on aging of the face.~   "
143516|NCT01688804|"~     Greater time spent in sedentary behaviors, independent of physical activity level, can~     increase risk of morbidity and mortality. Objective assessments indicate that bariatric~     surgery patients spend large amounts of time in sedentary behaviors. The present study is the~     first to test whether a mobile health (mHealth) approach that employs widely adopted~     smartphone technology to monitor and modify sedentary behaviors as they occur is a feasible~     and acceptable method of reducing sedentary time in these patients and other obese~     populations.~   "
143501|NCT01688999|"~     Background:~      - Cabozantinib is a drug that slows the growth of blood vessels that feed tumors. It is~     approved for medullary thyroid cancer. However, studies have shown that prostate and ovarian~     tumors respond to it. Researchers want see if cabozantinib can be a safe and effective~     treatment for urothelial cancer.~      Objectives:~      - To test the safety and effectiveness of cabozantinib for advanced urothelial cancer.~      Eligibility:~      - Individuals at least 18 years of age who have advanced urothelial cancer that has not~     responded to standard treatments.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will be collected. Tumor tissue samples will also be collected. Imaging studies~          will also be performed.~        -  Participants will take cabozantinib by mouth once per day on each day of a 28-day cycle.~        -  Treatment will be monitored with frequent blood tests and imaging studies.~        -  Participants will continue to take the study drug for as long as their cancer does not~          worsen and side effects are not too severe.~   "
143502|NCT01688986|"~     The Environmental Polymorphisms Registry (EPR) Health and Exposure Survey is designed to~     gather health, family history of disease, environmental exposures and lifestyle data on adult~     EPR subjects. The EPR is a registry established to collect and store DNA samples from 20,000~     volunteers from North Carolina and to serve as a resource to scientist investigating~     genotype-driven translational research of chronic conditions. Under this new protocol, we~     will administer a health and exposures survey to all EPR subjects. The information collected~     in the survey will be used to better characterize the EPR population thus making it more~     useful to NIEHS researchers. The survey contains approximately 200 questions. Data from the~     survey will help researchers develop hypotheses, design follow-up studies, and select~     appropriate subjects.~      The survey will be administered to EPR subjects using a modified version of the Dillman Total~     Design Method (TDM) for surveys. This method requires following specific time-dependent steps~     for survey administration that incorporate both self- and phone administration and other~     types of phone and mail contact. The goal of TDM is to maximize subject response rates.~   "
143503|NCT01688973|"~     This randomized phase II trial studies how well tivantinib with or without erlotinib~     hydrochloride works in treating patients with metastatic or locally advanced kidney cancer~     that cannot be removed by surgery. Tivantinib and erlotinib hydrochloride may stop the growth~     of tumor cells by blocking some of the enzymes needed for cell growth.~   "
143504|NCT01688960|"~     This is an open-label, multicenter, ascending, multiple dose study of nesvacumab (REGN910/~     SAR307746) in combination with aflibercept (ziv-aflibercept in the U.S.)~   "
143505|NCT01688947|"~     The primary objective of this study is to evaluate the analgesic efficacy of 2 dose levels of~     V116517 versus placebo.~   "
143506|NCT01688934|"~     The primary objective of this study is to evaluate the analgesic efficacy of 2 dose levels of~     V116517 versus placebo.~   "
143507|NCT01688921|"~     The purpose of this study is to determine if the administration of a seasonal flu vaccine~     using a PharmaJet's needle-free injection device (STRATIS) is equivalent to needle and~     syringe administration, as measured by laboratory tests of immune response.~   "
143508|NCT01688908|"~     To evaluate the efficacy of endoscopic screening on esophageal cancer (EC) and determine the~     most cost-effective strategy of endoscopic screening in high risk population in China, 668~     villages of Hua county, a high risk area of esophageal cancer, were randomized into screening~     arm and control arm in a ratio of 1:1 and the total sample size is over 32,000 (~16,000 per~     group). Participants in the screening arm will accept standard chromoendoscopy examination to~     detect early esophageal cancer and no screening were designed in the control arm. The~     incidence of advanced EC, EC-specific mortality and all-cause mortality will be compared~     within the two groups to test the hypothesis that endoscopic screening would alter the~     natural history of lesions in esophagus and the incidence of advanced stage EC, EC-specific~     mortality and all-cause mortality in the screening arm will be lower than the control group.~     Cost-effectiveness analysis will also be conducted to find the most cost-effective strategy~     of endoscopic screening in rural China.~   "
143509|NCT01688895|"~     The initial objective of this protocol is to assemble a well-documented group of patients~     with confirmed diagnoses of the erythropoietic protoporphyrias, including autosomal recessive~     Erythropoietic Protoporphyria (EPP) and X-Linked Protoporphyria (XLP) for clinical,~     biochemical, and genetic studies. The long-term objectives are (1) to conduct a longitudinal~     investigation of the natural history, complications, and therapeutic outcomes in people with~     erythropoietic protoporphyria, (2) to systematically investigate the psychological effects of~     the erythropoietic protoporphyrias on children and adults, and (3) to investigate the~     correlation between the identified genotypes and the resulting clinical presentation, also~     determining the possible interaction of other genetic markers.~   "
143510|NCT01688882|"~     To evaluate the safety and efficacy of QGE031 versus placebo in patients with bullous~     pemphigoid. Efficacy will be assessed as a reduction of disease activity. How QGE031 is~     broken down by the body and the impact it has on different blood and tissue markers will also~     be explored.~   "
143511|NCT01688869|"~     The purpose of the study is to gather information about patients with mild traumatic brain~     injury in order to develop guidelines for evaluation and treatment.~   "
143512|NCT01688856|"~     Impaired arm and hand function is one of the most disabling and most common consequences of~     stroke. The Investigators have developed Contralaterally Controlled Functional Electrical~     Stimulation (CCFES), an innovative neuromuscular electrical stimulation (NMES) treatment for~     improving the recovery of hand function after stroke. The purpose of this study is to~     maximize the treatment effect of CCFES by adding stimulated elbow extension. The specific~     aims and hypotheses are as follows:~      AIM 1: Estimate the effect of Arm+Hand CCFES on upper limb motor impairment and activity~     limitation.~      Hypothesis 1: Stroke survivors treated with Arm+Hand CCFES have better outcomes on upper limb~     impairment and activity limitation measures than those treated with dose-matched Arm+Hand~     Cyclic NMES.~      AIM 2: Estimate the effect of adding stimulated elbow extension to Hand CCFES.~      Hypothesis 2: Stroke survivors treated with Arm+Hand CCFES will have greater reductions in~     upper limb impairment and activity limitation than those treated with Hand CCFES.~      AIM 3: Describe the relationship between treatment effect and time elapsed between stroke~     onset and start of treatment.~      Hypothesis 3: Patients who start Arm+Hand CCFES sooner after their stroke achieve better~     outcomes.~   "
143517|NCT01688791|"~     This trial will be conducted in three parts. Part A is a dose escalation trial followed by a~     dose confirmation trial in folate receptor (FR) 100% endometrial cancer participants. The~     primary hypothesis of this trial is that administration of vintafolide in combination with~     carboplatin and paclitaxel is safe and tolerable. Part B is a single dose, dose escalation,~     pharmacokinetic (PK), and QTc interval trial. The primary objectives include determination of~     the maximum single tolerated dose of vintafolide and to evaluate the effect of this single~     maximum dose on the QTc interval. Part C is a weekly dose escalation trial of vintafolide~     followed by a dose confirmation. The primary hypothesis of this part is that weekly~     vintafolide has acceptable safety and tolerability in participants with advanced cancers.~   "
143518|NCT01688778|"~     The aim of the study is to investigate the effect of telemedicine among the group of~     type-2-diabetics who, despite rehabilitation, remain poorly regulated. To describe the~     patients with regards to vulnerability and social resources and to determine wich groups~     benefit the most from telemedicine.~   "
143519|NCT01688765|"~     The purpose of this study is to investigate the structural, functional and chemical brain~     abnormalities in patients with first episode psychosis and assess the evolution of these~     abnormalities during the course of the disease.~   "
143520|NCT01688752|"~     This is a prospective cohort study assessing measures of cardiometabolic status, body~     composition, IR and GH response to stimulation after therapy in children (age 7-21 years)~     treated for ALL. Patients and sibling controls will be recruited from the Pediatric~     Hematology-Oncology Clinic at the University of Minnesota Amplatz Children's Hospital.~   "
143521|NCT01688739|"~     The primary purpose of this study is to determine whether AMG 334 is safe and well tolerated~     in healthy subjects and migraine patients. As part of the secondary objectives, this study~     will be conducted to characterize the pharmacokinetics (PK) profile of AMG 334 after single~     SC or IV doses in healthy subjects and migraine patients as well as to characterize the~     effect of AMG 334 on the capsaicin-induced increase in dermal blood flow after single SC or~     IV doses in healthy subjects and migraine patients.~   "
143522|NCT01688726|"~     The purpose of this study is to evaluate the repeated use of SYSTANE® BALANCE on stabilizing~     the tear film of dry eye patients with an unstable tear film.~   "
143523|NCT01688713|"~     Brain metastases, a common complication,occur in 25-40% of patients with non-small cell lung~     cancer (NSCLC). Whole-brain radiation therapy(WBRT) and Stereotactic Radiosurgery (SRS) are~     important approaches to the treatment of brain metastases from NSCLC. Known to us, epidermal~     growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) can pass through the~     blood-brain barrier and show promising antitumor activity against brain metastases from~     NSCLC, especially for EGFR mutation patients. However, due to the lower concentration of~     tyrosine kinase inhibitors (TKIs) in the cerebrospinal fluid and its inevitable emergence of~     drug resistance, brain metastases will be refractory or resistant to standard-dose EGFR~     inhibitors. Icotinib is one agent of EGFR-TKIs. The previous studies have shown that the~     Icotinib conventional dose (125mg, TID) is far from reached its maximum tolerable dose. It is~     a challenge whether the further dose escalation of Icotinib will enhance its concentration in~     cerebrospinal fluid and thereby improve its therapeutic effect. Here the investigators~     examine the therapeutic effect and side-effect of double dose of Icitinib in treating~     patients with brain metastases from NSCLC who have suffered from the failure of conventional~     dose treatment.~   "
143524|NCT01688700|"~     A higher percentage of radical resection is reported in studies using neoadjuvant~     chemotherapy followed by surgery versus surgery alone for esophageal cancer. And neoadjuvant~     chemotherapy may improve overall survival after surgical resection. Nimotuzumab is a~     humanized monoclonal antibody against epidermal growth factor receptor (EGFR). The concurrent~     trial is a clinical phase II trial designed to assess the efficacy of the combination of~     Nimotuzumab administered concurrently with neoadjuvant chemotherapy in patients with~     resectable Esophageal Squamous Cell Carcinoma, and to further investigate its side-effect and~     toxicity~   "
143525|NCT01688687|"~     Confocal endomicroscopy (CLE) allows real-time in-vivo high-resolution and high-magnification~     imaging of the gastrointestinal epithelium, which is comparable to histopathology. Previous~     studies have investigated the accuracy of pCLE for diagnosis and differentiated of colorectal~     polyps, Barrett's esophagus and pancreaticobiliary strictures. However, to date there are~     limited data exploring the application of pCLE to gastric lesions, and this is the first~     study comparing the diagnosis of conventional forceps biopsy with that of pCLE using the~     final specimens obtained from endoscopic resection as a reference standard. The aims of this~     study were (1) the accuracy of pCLE compared to conventional forceps biopsy using~     histopathology results following endoscopic resection as a reference, and (2) comparison of~     real time in-vivo pCLE diagnosis with that of blinded off-line pCLE diagnosis, and~     off-line interobserver agreement.~   "
143526|NCT01688674|"~     NULL HYPOTHESIS • There is no difference in the incidence of hypoglycemia among preterms~     receiving either two hourly 10% dextrose boluses or 10% dextrose infusion by burettes during~     the 72 hours of admission in Special Care Unit- Mulago Hospital.~      ALTERNATE HYPOTHESIS~      • Use of two hourly 10% dextrose boluses increases the incidence of hypoglycemia by 30%~     compared to 10% dextrose infusion by burettes among preterms admitted to Special Care Unit in~     the first 72 hours of admission.~   "
143527|NCT01688661|"~     The sniffing position has been regarded as a standard position for direct laryngoscopic view.~     This study evaluated the effects of the age and gender on the advantage of the sniffing~     position compared with simple head extension for laryngeal view during direct laryngoscopy.~   "
143528|NCT01688648|"~     The aim of the present study is to compare the antiarrhythmic and myocardial protective~     effect between lidocaine, dexmedetomidine, and their combined infusion in subjects undergoing~     coronary artery bypass graft.~   "
143529|NCT01688635|"~     The purpose of this study is to compare the pharmacokinetics and pharmacodynamics of~     LY2963016 and US-approved Lantus®. The study involves four single injections; two doses of~     LY2963016 and two doses of US-approved Lantus®. The study will have 4 periods. In each~     period, a single injection will be administered before undergoing a euglycemic clamp that~     lasts for 24 hours. There will be at least a 7 day washout between each period. Side effects~     will be documented. Study participation is expected to last up to 14 weeks.~   "
143530|NCT01688622|"~     Glypican4, CTRP3, CTRP5 are emerging novel adipokines mediating obesity and inflammation~     related disorders. RBP4 and adiponectin are well known important adipokines. Therefore, we~     examine the circulating levels of theses adipokines in the subjects with or without metabolic~     syndrome. Furthermore, we tried to clarify the effect of exercise on the circulating these~     adipokines.~   "
143531|NCT01688609|"~     This phase II trial studies how well giving lapatinib ditosylate together with trastuzumab,~     paclitaxel, and surgery works in treating patients with breast cancer. Lapatinib ditosylate~     may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.~     Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some~     block the ability of tumor to grow and spread. Others find tumor cells and help kill them or~     carry cancer-killing substances to them. Drugs used in chemotherapy, such as paclitaxel, work~     in different ways to stop the growth of tumor cells, either by killing the cells or by~     stopping them from dividing.~   "
143532|NCT01688596|"~     The primary objective of this study is to assess if injection of local anesthetic to the~     laparoscopic trocar sites after a hysterectomy will make a difference in a patient's pain~     after surgery.~   "
143533|NCT01688583|"~     The purpose of this study is to assess the effectiveness and tolerability of Fentanyl matrix~     in chronic non-cancer pain.~   "
143534|NCT01688570|"~     While baseline weakness is clearly an important factor that contributes to disability post~     stroke, neuromuscular fatigue (the acute reduction in force production) of the paretic~     musculature likely compounds strength deficits and further exacerbates disability. The~     proposed study aims to improve our understanding of the mechanisms of neuromuscular fatigue~     in people post stroke in order to optimize strength training. In healthy individuals, both~     central (neural) and peripheral (muscle) factors are determinants of neuromuscular fatigue,~     but preliminary data from our laboratory suggests a greater contribution of central~     components to neuromuscular fatigue in the paretic musculature. Although cortical pathways~     are clearly disrupted post stroke, it is likely that brainstem pathways, known to have~     neuromodulatory effects on spinal motor circuitry, are more involved in the sustaining of~     force in the paretic leg, compared to the non-paretic and control legs. Therefore, the~     purpose of this proposal is to examine the role of descending neuromodulatory pathways of the~     brainstem in neuromuscular fatigue post stroke (Aim 1) and to correlate brainstem-related~     changes in neuromuscular fatigue to walking function (Aim 2). The investigators propose that~     stroke survivors' decreased capability to sustain force overtime results from the diminished~     ability of spinal motoneurons to respond to brainstem neuromodulatory inputs (serotonin~     (5-HT) and norepinephrine (NE)). Aim 1 will quantify stroke-related decreases in motor output~     sensitivity to a 5-HT and NE reuptake inhibitor (SNRI), serotonin antagonist, or placebo~     during sub-maximal intermittent fatiguing knee extension contractions. If motoneurons are~     desensitized to descending monoamines in chronic stroke patients, then they will be less~     sensitive to the effects of drugs that increase monoamine levels. The investigators predict~     that in response to the SNRI or serotonin antagonist, the paretic leg will show less change~     in time to task failure and a smaller reduction in strength as compared to the non-paretic~     and control legs. For Aim 2, the investigators predict that stroke subjects with the highest~     walking function will demonstrate the greatest fatigue-related changes in response to the~     SNRI. This proposal adopts an innovative model of motor impairment post stroke by including~     the role of subcortical structures in neuromuscular fatigue.~   "
143535|NCT01688557|"~     The trial will compare results of screening colonoscopy performed by means of conventional~     colonoscopy and using new visualisation techniques during endoscopic examination.~        -  Electronic colonoscopes Olympus CF-HQ190F with following options: magnetic positioning~          (Scope Guide), responsive insertion technology (RIT), dual focus function, narrow band~          imaging (NBI) will be used for innovative colonoscopies~        -  Electronic colonoscopes Olympus CF-H180DL with Scope Guide and NBI options will be used~          for conventional colonoscopies Endoscopists will archive all images and establish~          presumptive diagnosis based on the results of different visualisation techniques. All~          endoscopes will be attached to Olympus Evis Exera III system. Biopsy of all pathological~          lesions will be performed to establish final diagnosis. The main outcome measure is~          diagnostic accuracy of innovative colonoscopy in comparison with conventional technique.~   "
143536|NCT01688544|"~     Ilaprazole is a novel proton pump inhibitor and metabolized by CYP3A4 and 2C19. Thus genetic~     polymorphisms of CYP3A4 and 2C19 may have effect on the pharmacokinetics and pharmacodynamics~     of Ilaprazole.~   "
143537|NCT01688531|"~     Exploratory, international, multi-centre, randomized, investigator blinded study in acne~   "
143538|NCT01688518|"~     This will be a randomized, single-blind, active-controlled, two-period crossover study in~     adult volunteers to compare the duration and depth of anesthesia between Synera® and~     Lidoderm® patches when applied for 30 minutes and 4 hours. The study will include a Screening~     Visit, two Treatment Periods, and a Follow-Up Phone Contact.~   "
143539|NCT01688505|"~     Hypertension in midlife is an independent risk factor of late life cognitive dysfunction or~     dementia. Chronic hypertension cause vascular damage and cerebral ischemia, which ultimately~     gives rise to the cognitive dysfunction or dementia.~      A recent study showed that high visit-to-visit variability in clinic systolic blood pressure~     (BP) was a strong independent predictor of stroke. This finding suggests that high clinic~     systolic BP variability itself as well as chronic hypertension may cause vascular damage and~     cerebral ischemia. Therefore, high clinic SBP variability may be also an independent risk~     factor of cognitive dysfunction or dementia.~      Vascular damage leads to the diminished autoregulatory capacities of cerebral arteries. The~     brain with the reduced autoregulatory capacity may be more vulnerable to BP fluctuation.~     Therefore, high BP variability may be more harmful in patients with damaged vessels (for~     example, in patients with cerebral small vessel disease).~      Previous data about BP variability and cognition revealed very controversial. Some studies~     showed poor cognition in patients with high BP variability, but others did not.~      The previous studies were mostly based on cross-sectional designs, and performed in~     small-sized heterogeneous population for primary prevention. The harmful effect of high BP~     variability may be clearer in the population with damaged vascular bed, such as cerebral~     small vessel disease. The previous studies usually used ambulatory BP monitoring (ABPM).~     However, recent data suggested that variability in BP on ABPM may be a weaker predictor of~     vascular events than be visit-to-visit variability in clinic BP.~      The investigators sought to find whether high visit-to-visit variability in clinic BP is~     related with poor cognitive function in patients with cerebral small vessel disease.~   "
143540|NCT01688492|"~     The purpose of this study is to find out what effects, good and/or bad, taking ipilimumab~     with abiraterone acetate plus prednisone has on the patient and the prostate cancer.~     Abiraterone acetate plus prednisone are drugs that lower testosterone (testosterone~     stimulates prostate cancer growth). Abiraterone acetate plus prednisone is a treatment for~     patients with prostate cancer.~      Abiraterone acetate plus prednisone has not been used together with ipilimumab before. This~     study will test how they work together. Each patient will receive abiraterone acetate,~     prednisone and ipilimumab.~   "
143541|NCT01688479|"~     Acute radiation skin reactions (ARSR) occur in the majority of patients undergoing~     postoperative radiotherapy (RT). Some patients experience more severe reactions such as dry~     and/or moist desquamation but most patients experience mild reactions e.g. erythema (Lopez et~     al., 2005). The radiation dose, volume, RT technique and previous treatment, such as type of~     surgery and previous chemotherapy, are factors that might impact on the risk for ARSR~     together with patient-related factors such as body mass index (BMI), smoking status and~     previous skin damage (Porock et al., 1998; Wells et al., 2004). In a pilot study (n=93) of~     the frequency of ARSR in patients with breast cancer who underwent adjuvant RT it was shown~     that 93% developed ARSR, mostly mild reactions. Patients reported low scores on pain and~     itching (Sharp et al., 2011). Over 80% of the patients reported adherence to the skin care~     recommendations which included application of a thin layer of Essex® cream, a non-perfumed~     aqueous cream, on the irradiated area at least two times a day (Sharp et al., 2011). The~     effects of skin care products containing Calendula Officinalis (marigold plant) on ARSR in~     patients with breast cancer were investigated in a randomized clinical trial (Pommier et al.,~     2004). Patients in the experimental group, treated with calendula cream had a statistically~     significant lower incidence of severe ARSR, pain and treatment interruptions in comparison~     with the patients in the control group, treated with trolamine.~      The purpose of this blinded, randomized clinical trial is to compare two topical agents,~     Calendula Weleda® cream and Essex® cream, in terms of efficacy to reduce the risk of severe~     acute radiation skin reactions (ARSR) in relation to adjuvant radiotherapy (RT) for breast~     cancer.~      Patients were instructed to apply a thin layer of the assigned cream twice a day, starting at~     the onset of RT and continue until two weeks after termination, or until the ARSR is healed.~     The application should include the whole treatment area including the armpit and~     shoulder/back area in patients treated with modified radical mastectomy. Patients are also~     advised to not apply the cream within two hours before the RT in order to avoid possible~     build-up effect. Daily wash with perfume free soap and tap water are recommended and patients~     are advised to refrain from use of other topical agents in the irradiated area.~      The primary endpoint is the efficacy to reduce acute radiation skin reactions (ARSR),~     assessed with the Radiation Therapy Oncology Group/The Organization for Research and~     Treatment of Cancer Acute Radiation Morbidity Scoring Criteria (RTOG/EORTC scale) at~     follow-up.~      Secondary endpoints include patient reported outcome measures; Quality of Life Questionnaire~     (QLQ-C30), Sleep disturbances (MOS-sleep questionnaire) and symptoms experienced from the~     irradiated area (visual analogue scale). Patients' experiences and adherence to the topical~     agents are also evaluated.~      A total of 400 patients are required to detect a true absolute reduction in the proportion of~     patients with ARSR, from 35% with standard treatment (Essex® cream) to 20% with the~     experimental treatment (Calendula Weleda® cream), with a significance level of 5% a power of~     90%. With this sample size, 95% confidence intervals for the difference in proportions are~     estimated to be in the order of ±10%. Assuming a rate of 5% of non-responders, the target~     size has been set to 420 patients.~   "
143542|NCT01688466|"~     Background:~      - Pomalidomide is a drug that alters the body's immune response. It may help people who have~     chronic graft-versus-host disease (GvHD). GvHD may appear after a stem cell transplant, when~     immune cells in the transplant try to attack tissues in the person who received the~     transplant. GvHD is not easy to treat, and often does not respond to standard treatments.~     Researchers want to see if pomalidomide is a safe and effective treatment for GvHD.~      Objectives:~      - To test the safety and effectiveness of pomalidomide for GvHD that has not responded to~     standard treatments.~      Eligibility:~      - Individuals at least 18 years of age who have GvHD that has not responded to standard~     treatments.~      Design:~        -  Participants will be screened with a physical exam and medical history. Blood and urine~          samples will also be collected. A lung function test and imaging studies will also be~          given.~        -  Participants will take pomalidomide capsules once a day for 4-week periods called~          cycles.~        -  Treatment will be monitored with frequent blood tests and imaging studies. Saliva~          samples and skin and mouth tissue biopsies will also be collected during treatment.~        -  Treatment will continue for six cycles (6 months), unless the GvHD gets worse or side~          effects are too severe. If the GvHD has improved at the end of the six cycles,~          participants may be able to continue to take pomalidomide for up to six more cycles.~   "
143543|NCT01688453|"~     Background: The prevalence of overweight and obesity continues to increase in socially less~     advantaged populations but is stabilizing even is decreasing in socially more advantaged~     populations. The PRALIMAP trial highlighted the effectiveness of structured screening and~     care management in decreasing the prevalence of overweight and obesity in high school~     adolescents over 2 years. The PRALIMAP-INES trial aims to investigate whether a strengthened~     care management (CM) for socially less advantaged adolescents in school in the short and long~     term has an equivalent effect as a standard-CM on decreasing the prevalence of overweight and~     obesity among socially advantaged adolescents.~      Intervention: PRALIMAP-INÉS is a mixed prospective and multicenter trial of 1,250 overweight~     and obese adolescents aged 13 to 18 years who are attending grade 9 and 10 in the 35~     state-run schools of the Vosges department (northeastern France) for the academic years~     2012-2013 2013-2014 and 2014-2015. Overweight adolescents (including obese) classified as~     advantaged are allocated to the standard-CM and those less advantaged are randomized to~     standard CM or strengthened-CM. The standard-CM consists of 5 collective sessions of 2 hr~     each performed in high school and supervised by a healthcare mobile team specialised in~     overweight and obesity care management for adolescents. The strengthened-CM consists of 5~     collective sessions with the same standard operating procedure as the standard-CM with~     supplementary interventions between each session: strengthened solicitation with the~     adolescent and the family, peer-led educational sessions, motivational interviews, financial~     support for physical activity practice, cooking classes and multidisciplinary consultation~     meetings. Data on sociodemographics, anthropometrics, physical activity and mental health are~     collected at 3 visits: at the entry to grade 9 or 10 (before the intervention=T0), at the end~     of grade 9 or 10 (at the end of the intervention=T1) and at the end of grade 11 (1 year after~     the intervention=T2). Process evaluation data are also collected during the trial.~      Expected results: To confirm the effectiveness of overweight CM for adolescents in a school~     setting and to highlight or not the effectiveness of specific strengthened interventions~     adapted for socially less advantaged adolescents to maintain social equality in access to~     overweight care.~   "
143544|NCT01688440|"~     When babies are sick, or are born prematurely, they sometimes need an endotracheal (ET) tube~     to assist their breathing and/or a nasal canula. The investigators must periodically irrigate~     the ET tube to prevent them from being plugged up by secretions. The investigators also, due~     to the drying effects of nasal canula, periodically moisten the nasal passages of babies.~     Presently 0.9% saline is the solution being used for moistening of the ET tube, nose, as well~     as oral cares will infant is not eating. However, scientists have recently learned that~     saline can destroy the body's natural antibacterial properties in the windpipe, nose, and~     mouth.~      The investigators have developed a new solution to be used in place of saline for~     endotracheal (ET), nasal, and oral cares. The investigators' new solution is patterned after~     the natural fluid in the windpipe, nose, and mouth.~      Study Hypothesis:~        1. Patients who receive ETCare will have no increase in adverse events related to its~          administration, compared with 0.9% saline.~        2. Patients who receive ETCare will have a lower proportion of tracheal aspirates where~          pathogens are reported.~        3. Patients who receive ETCare will have a lower proportion of tracheal aspirates where~          leukocytes are reported.~        4. Patients who receive ETCare will have fewer (risk-adjusted) days of supplemental oxygen.~   "
143545|NCT01688427|"~     This research is being done to test whether mobile technology will reduce possible~     communication barriers between women and their home visitor; to improve assessing for health~     problems that could affect their pregnancy; to help in the delivery of information and~     actions to improve the health of the woman and their child.~   "
143546|NCT01688414|"~     This pilot clinical trial studies imaging during surgery in diagnosing patients with~     prostate, bladder, or kidney cancer. New diagnostic imaging procedures, may find prostate,~     bladder, or kidney cancer~   "
143547|NCT01688401|"~     The goal of this pilot study is to determine if intra-arterial (IA) chemotherapy is safe in~     the treatment of progressive diffuse intrinsic pontine gliomas (DIPG). IA administration of~     the chemotherapeutic agent enhances the regional distribution of the drug, thereby increasing~     the local delivered dose while minimizing systemic toxicity. It also provides a treatment~     option for these patients at the time of tumor recurrence.~   "
143548|NCT01688388|"~     This clinical trial is being conducted to find out the effects (good and bad) of giving the~     full radiation treatment for breast cancer as a single dose of radiation during surgery for~     breast cancer. This single fraction intraoperative radiotherapy with electrons will study the~     toxicity, local control and cosmetic outcome.~   "
143549|NCT01688375|"~     ABSTRACT:~      In patients with obstructive jaundice, multi-organ dysfunction may develop. The aim of this~     study is to evaluate the effect of ursodeoxycholic acid on liver functional restoration on~     patients with obstructive jaundice after surgical or endoscopic treatment.~      Patients with obstructive jaundice will be divided into two groups: (A) test group in which~     will be administered ursodeoxycholic acid twenty-four hours after endoscopic or surgical~     procedure and will last fourteen days, and (B) control group.~      Serum-testing will include determination of bilirubin, alanine transaminase, aspartate~     transaminase, gama-glutamyl transpeptidase, alkaline phosphatase, albumin, and cholesterol~     levels. These parameters will be determined one day prior endoscopic or surgical procedure,~     and on the third, fifth, seventh, tenth, twelfth and fourteenth days after endoscopic or~     surgical intervention.~      Our hypothesis is that patients with obstructive jaundice under treatment with~     ursodeoxycholic acid will have better outcome than patients in control group.~   "
143566|NCT01688154|"~     Grape seed proanthocyanidins have been reported to possess a hypotriglyceridemic effect after~     an acute or chronic consumption in rodents. In this study, we aimed to investigate the~     effects of an acute consumption of proanthocyanidins before a breakfast meal in humans.~     Moreover, the mechanisms implicated in the reduction of plasma triglycerides levels by grape~     seed proanthocyanidins in humans should be elucidated as well as its activity on vascular~     function.~   "
143550|NCT01688362|"~     The purpose of this study is to further define the optimal non-surgical treatment strategy~     for partial thickness rotator cuff tears. The specific aim of this study is to determine the~     outcomes of treatment of partial thickness rotator cuff tears with corticosteroid or platelet~     rich plasma (PRP). Subjects with partial thickness rotator cuff tears will be randomized to~     receive an injection of PRP or corticosteroid. Shoulder function and tendon healing will be~     evaluated using the patient surveys as well as ultrasound. Subjects will be followed for one~     year to determine the outcomes for each treatment. The hypothesis is that there is no~     difference in healing rate or functional outcomes in patients treated with corticosteroid~     injections vs. PRP injections for the treatment of partial thickness rotator cuff tears.~   "
143551|NCT01688349|"~     The purpose of this trial is to investigate the impact of cortisol on adipose tissue~     functions, distribution and morphology. Patient with endogenous blood cortisol excess exhibit~     changes in adipose tissue, with fat gain in the upper trunk, face and neck leading to~     visceral obesity and features of the metabolic syndrome. The aims of this study will be~        -  to compare the pattern of gene expression between visceral and subcutaneous adipose~          tissue in Cushing patients requiring an adrenalectomy as cortisol adenoma treatment;~        -  to compare these patterns of gene expression with those of two control populations:1/~          healthy metabolic subjects having a partial nephrectomy, 2/obese patients with similar~          degree of insulin resistance.~   "
143552|NCT01688336|"~     This single arm, multi-center phase II clinical trial will assess the safety and efficacy of~     FOLFIRINOX in the first-line setting in patients with unresectable locally advanced (ULA) and~     borderline resectable (BR) pancreatic cancer.~   "
143553|NCT01688323|"~     To look at what types of measures can be used to predict how an older person will tolerate~     chemoradiation treatment for head and neck cancer. This study uses surveys and a blood draw~     to look at the different measures.~   "
143554|NCT01688310|"~     This proposed randomized controlled trial will provide important data which will inform and~     enable the Mozambican government and global health programs to more effectively scale-up~     circumcision services. The investigators postulate that voluntary medical male circumcision~     using the Gomco clamp coupled with tissue adhesive meets WHO criteria for the ideal method:~     it is much easier to learn, faster, safer for both surgeons and patients, heals sooner, and~     is more cost effective than any other currently available technique.~   "
143555|NCT01688297|"~     The purpose of this study was to demonstrate the safety and immunogenicity of an oral vaccine~     tablet to prevent seasonal influenza. The study was a placebo controlled, double blinded~     trial at a single site. The study was conducted under two separate protocols. Initially~     single administrations at two dose levels (low dose and mid dose) of the oral vaccine was~     tested in a placebo controlled study (37 subjects). And subsequently a single high dose of~     the oral vaccine was tested in a separate placebo-controlled study (24 subjects).~   "
143556|NCT01688284|"~     The aim of the study is to evaluate the role of uterine natural killer cell(uNK)in recurrent~     pregnancy losses and the correlation between the numbers of it and embryo toxicity by~     measuring the level of the Th2 cytokines in normal reproductive profile and in patients with~     Recurrent Pregnancy Losses (RPL).~   "
143557|NCT01688271|"~     This study will determine the efficacy of a teaching program incorporating hybrid simulation~     in training practicing anesthesiologists on ultrasound (US)-guided continuous peripheral~     nerve block (CPNB).~      This study will also examine the extent of practice change following participation in a~     regional anesthesia teaching program incorporating hybrid simulation. In addition, this study~     will assess remaining obstacles to incorporating the use of US-guided perineural catheters~     through identifying potential future interventions and tool-kits for setting up perineural~     catheter programs.~   "
143558|NCT01688258|"~     (i) To compare a new diagnostic PCR with established diagnostic procedures for T. pallidum~     (serology, dark field microscopy), H. ducreyi (cultivation), HSV types 1 and 2 (cultivation,~     PCR).~      (ii) To assess the frequency of infections with T. pallidum, H. ducreyi and HSV types 1 and 2~     in patients with genital, anal and oropharyngeal ulcers by a new PCR.~   "
143559|NCT01688245|"~     Investigators aim to test the effectiveness of a text-message-based behaivoral intervention~     in reducing binge drinking among young adults.~   "
143560|NCT01688232|"~     Medical and Scientific Background: Colorectal cancers (CRC) are the leading cancers in both~     genders. This cancer is of prognostic severity. The prognosis of this cancer has not been~     significantly improved. The treatment of colonic cancer is primarily based on surgery.~     Adjuvant chemotherapy is proposed for metastatic cancers (stages III and IV). However nearly~     30% of patients with localized cancer (stage II) will present a recurrence. Despite intense~     research efforts, no markers of sufficient prognostic value (independent of TNM) are~     available to identify this group of patients and justify intensified therapy. The natural~     history of cancer involves interactions between the tumor and the immune system of the host.~     The immune infiltration at the tumor site may be indicative of host response. We showed that~     the density of intratumor memory T cells (CD45RO) and cytotoxic T cells (CD8) in tumor~     regions (the core and the invasive margin) influenced the occurrence of early events of~     metastasis (tumor emboli) and was strongly associated with prognosis of patients with CRC~     (Pagès et al, NEJM-2005). This immune criterion was a better predictor of survival than the~     gold standard histoprognostic data of tumor invasion (T stage and N) and allowed to~     identify a group of patients at high risk of recurrence (*2). The availability of this immune~     criterion in clinical practice could improve the prognostic assessment of patients and better~     guide the therapeutic. A dedicated platform has been implemented in our hospital to speed up~     the transfer of this immune investigation into the clinic. The investigation takes into~     account the density of immune cell populations in tumor regions (the core and the invasive~     front of the tumor). This methodology has been validated for the markers CD45RO, CD3 and CD8~     and leads to the creation of an immune score (immunoscore ranging from IO to I4). We~     validated the prognostic impact of the immunoscore in a retrospective series of 250~     colorectal cancers. The main objective of this multicentric prospective clinical study is to~     assess in clinical practice the immunoscore and measure its prognostic value. The cohort~     study will include 400 patients with CRC stage I to IV (6 centers for inclusion; Paris-HEGP,~     Dijon, Bobigny-Avicenne, Besancon, Poitiers, Rouen). Two years of inclusion and a follow-up~     of 3 years for each patient will be performed (co-financing for data collection during the~     4th and 5th year planned). For each patient, the pathologist of the center will send to the~     immunomonitoring platform of HEGP tissue sections from a paraffin block containing the tumor~     regions. The investigations will combine a step of immunostaining for CD3, CD8, and CD45RO~     (Ventana automate) markers, high-resolution scanning of the stained slides and quantification~     of digital images by an imaging module developed by our group from the program of Developer~     XD of Définiens company. The immunoscore will be calculated and the score will be correlated~     to the clinical data for the relapse and the survival. The secondary objective of this~     program is to evaluate the prognostic performance of the immune infiltrate on the biopsies~     performed for diagnostic purposes. This study will be conducted on patients of the cohort~     whose biopsies were performed in the same hospital than surgery and whose samples are~     available in pathology laboratories involved (representing 50% of cases). For the same~     patients will be conducted a genetic investigation of the tumor to assess the MSI status, the~     presence of a K-Ras and BRAF mutations. This investigation will be performed on tumor~     sections from the same tumor block selected for the immunohistochemical analyses. The~     sections will be processed by the Department of Biology, Hôpital Européen Georges Pompidou.~     The prognostic performance of the immune investigations performed on tumor sections and~     biopsies will be compared to that of genetic features of the tumor. Finally, a questionnaire~     will be sent every six months along the monitoring of the patients to obtain information~     concerning (i) the emergence of an immune disorder (such as allergy, autoimmunity,~     inflammatory process) and (ii) the psychological status of the patients. The potential impact~     of such parameters during the course of the disease on the prediction of the relapse and~     survival obtained with the immunoscore performed at the time of surgery will be evaluated.~     Expected results : This prospective study is an indispensable step for the clinical~     validation of the prognostic value of the immunoscore. The secondary objectives should help~     to precise the benefit of a concomitant analysis of the biopsy, the genetic features of the~     tumor. The questionnaire should help to identify the clinical parameters to track along the~     monitoring~   "
143561|NCT01688219|"~     The aetiology of SAPHO syndrome seems to involve genetic, infectious and immunological~     components. The investigators examined innate and adaptative immune responses in SAPHO~     syndrome as compared with psoriatic arthritis and rheumatoid arthritis.~   "
143562|NCT01688206|"~     This multi-center, open-label study will evaluate the safety, pharmacokinetics,~     pharmacodynamics and preliminary efficacy of vanucizumab as a single agent or in combination~     with atezolizumab in participants with locally advanced or metastatic solid tumors. Cohorts~     of participants will receive escalating doses of vanucizumab, fixed dose of vanucizumab (MTD~     and/or recommended phase two dose [RP2D]), and fixed dose of vanucizumab in combination with~     atezolizumab, intravenously every 2 weeks.~   "
143563|NCT01688193|"~     The purpose of this study is to Evaluate and Compare Safety and Pharmacokinetics of the~     HCP1004 and VIMOVO 500/20mg in Healthy Korean Male~   "
143564|NCT01688180|"~     Patients with chronic diseases are at great risk of depression and anxiety.It is known that~     depression and anxiety are one of the most common comorbidities associated with chronic lung~     diseases such as asthma and chronic obstructive pulmonary disease.~      However,to date,little is known about the rates and risk factors of depression and anxiety~     symptoms in non-CF bronchiectasis;and no large-scale prospective studies have been performed~     to investigate the effect of depression and anxiety on the healthy outcomes(such as number of~     exacerbations and hospitalizations over the ensuing year).Our purpose is to fill these gaps.~   "
143565|NCT01688167|"~     This study proposes to balance supply and demand of male circumcision through a systematic~     scale-up of coordinated biomedical surgical and behavioral counseling services. The study~     will compare the combined biobehavioral sexual risk reduction intervention to the standard of~     care, which focuses exclusively on the provision of circumcision services alone, with the~     goal of optimizing both local and national HIV prevention efforts.~   "
145019|NCT01669174|"~     This study will assess the pharmacodynamics, pharmacokinetics, safety and tolerability of~     BYM338 in patients with COPD and cachexia. The primary outcome will be a change in thigh~     muscle volume compared to placebo. The study will last for approximately 24 weeks.~   "
143567|NCT01688141|"~     Chronic kidney disease (CKD) is a major public health problem with a UK prevalence of 8-10%.~     The study hypothesis is to ascertain if intensive primary care led disease management~     programmes for CKD, supported by input from secondary care specialists will slow progression~     of CKD, improve blood pressure control and reduce cardiovascular events in patients on CKD~     registers.~      The investigators have partnered with Nene commissioning, a practice based commissioning~     group representing approximately 80 GP practices in Northamptonshire, to run this study. This~     will be a cluster randomised trial of an intensive, secondary care supported, CKD management~     programme in primary care vs normal CKD care. Randomisation will be at the level of the~     individual general practice. All general practices associated with Nene commissioning will be~     invited to participate. Randomisation of practices will be performed by the University of~     Leicester Clinical Trials Unit and the study will adhere to guidelines for undertaking~     randomised cluster trials.~      The aims of the study are:~        1. To determine whether reinforcement of best practice in the management of key aspects of~          CKD care by clinical nurse specialists based in primary care, but with close links to~          colleagues from secondary care, improves clinical outcomes.~        2. To foster excellence in CKD care~        3. To improve coding of CKD and prevalence on chronic disease registers.~        4. To increase interest in, and capacity for primary care research in Northamptonshire.~        5. To implement and evaluate a new model of partnership working between primary and~          secondary care.~      The primary outcome measures will be changes in estimated glomerular filtration rate (eGFR).~     Secondary outcome measures will be blood pressure control, proteinuria, incidence of~     cardiovascular events,other biochemical parameters, referrals to secondary care and~     hospitalisations and mortality.~   "
143568|NCT01688128|"~     The purpose of this study is to examine the efficacy of the Ubiquitous Spaced Retrieval-based~     Memory Advancement and Rehabilitation Training (U-SMART) in the elderly individuals with mild~     cognitive impairment (MCI) by an open-label, controlled, crossover Trial.~   "
143569|NCT01688115|"~     The purpose of this study is to evaluate the efficacy of a video shown using an iPad,~     compared to a standard treatment, to reduce preoperative anxiety in children who have to~     undergo to elective surgery procedure~   "
143570|NCT01688102|"~     Participants in this study will be randomized to receive either oral vitamin D pills OR~     ultraviolet light treatment. The investigators will compare how these two methods of raising~     vitamin D levels will affect cholesterol levels.~   "
143571|NCT01688089|"~     The purpose of this study is to evaluate the safety and tolerability of escalating doses of~     ODM-103 when given to healthy male volunteers.~   "
143572|NCT01688076|"~     This cross-over design study will evaluate the onset of action, efficacy, and duration of~     botulinum toxin A treatment on forehead/glabellar rhytid complexes with and without~     subsequent muscle contraction.~   "
143573|NCT01688063|"~     The primary objective of Part A is to compare the change in elasticity measurements at~     baseline and at 3 months between subjects who have had a resurfacing or tightening procedure~     and those who have not. The secondary objective for Part A is to develop baseline elasticity~     scores for ages 18-35, 36-50, and 51-65 and for Fitzpatrick skin types I-II, III-IV, and~     V-VI. The primary objective of Part B is to compare the age of the scar and surrounding~     tissue with the elasticity measurements.~   "
143574|NCT01688050|"~     The TRANSFIX study is a clinical trial approved by US FDA to study the safety and~     effectiveness of the Zenith® TX2® Low Profile Endovascular Graft for treatment of Blunt~     Thoracic Aortic Injury.~   "
143575|NCT01688037|"~     The purpose of this study is to evaluate the efficacy, safety, and tolerability of two doses~     (50 and 100 mg) of NBI-98854 administered once daily for the treatment of Tardive Dyskinesia~     (TD) symptoms.~   "
143576|NCT01688024|"~     The purpose of this study is to determine the effectiveness and safety of mitomycin C in the~     treatment of primary sclerosing cholangitis (PSC).~   "
143577|NCT01688011|"~     The purpose of the Connect® MDS/AML Disease Registry is to provide unique insights into~     treatment regimens and sequencing of these regimens as they relate to clinical outcomes of~     patients with newly diagnosed MDS, ICUS or AML in routine clinical practice and evaluate~     molecular and cellular markers that may provide further prognostic classification and/or~     might be predictive of therapy outcomes.~   "
143578|NCT01687998|"~     The purpose of the ACCELERATE study is to evaluate the efficacy and safety of evacetrapib in~     participants with high-risk vascular disease (HRVD).~   "
143579|NCT01687985|"~     A pilot study to evaluate the safety and efficacy of multiple BLI801 doses in constipated~     adults.~   "
143580|NCT01687972|"~     The proposed study is a randomized controlled trial with two arms. All patients admitted to~     Labor and Delivery at Johns Hopkins Hospital for delivery will be approached and offered~     entry into our study. Once the patient is enrolled, and if she undergoes a cesarean section,~     the patient will be randomized at time of cesarean section to receive skin closure by either~     the INSORB™ absorbable staples or subcuticular closure using Biosyn™ suture as is the~     standard practice. Both an observer scar assessment score (OSAS) and patient scar assessment~     score (PSAS) will be obtained during this visit. The patient will then be contacted by~     telephone by a study member 3 months after her surgery for a brief survey (same PSAS survey)~     assessing her satisfaction with the resulting scar.~   "
143581|NCT01687959|"~     Timing of laparoscopic cholecystectomy following after endoscopic retrograde cholangiography~     for acute biliary pancreatitis is a controversial issue. There are still many confounding~     findings offering either early laparoscopic cholecystectomy within 72 hours following~     endoscopic sphincterotomy or delayed surgery after 6 weeks. Peritoneal plasmin system is~     known to be an important factor in peritoneal healing and adhesion formation. Measurement of~     tissue concentrations of tissue-type plasminogen activator and its specific activity,~     urokinase-type plasminogen activator, and plasminogen activator inhibitor type 1 are thought~     to be helpful to show peritoneal adhesions after endoscopic sphincterotomy.~   "
143591|NCT01687829|"~     Since Kelly and Wendel first reported successful closure of idiopathic macular holes (MH) by~     vitrectomy in 1991, many surgical modifications have been made to improve the anatomical and~     visual outcomes of this surgery. Recently, internal limiting membrane (ILM) peeling has~     become used widely as an adjunctive procedure during MH surgery because the removal of ILM is~     thought to reduce the tangential traction on the macula, a major factor in the pathogenesis~     of idiopathic macular holes. However, the role of ILM peeling in macular hole surgery is not~     yet well defined. To the best of our knowledge, there is no meta-analysis on comparison of~     the efficacy of ILM peeling and suture for MH surgery. This study reviewed the published~     literature comparing surgical results with and without ILM peeling and and performed a~     meta-analysis to determine whether there is any benefit or detriment anatomically and/or~     visually.~   "
143718|NCT01686178|"~     The goal of the study is to implement and evaluate interventions to decrease smoking among~     young adults attending bars and nightclubs. It is believed that the proportion of young adult~     current smokers during and after the intervention will be significantly less than the~     proportion of young adult smokers before the intervention in each of the study cities.~   "
143582|NCT01687946|"~     RESOLVE's objective is to identify and characterize validated molecular targets capable of~     shifting primary organ repair towards fibroproliferative wound healing.~      Work package 2 (WP2) of RESOLVE includes the clinical study protocols within the RESOLVE~     system evaluating different forms of pulmonary repair in humans ranging from normal repair~     over mainly inflammatory to predominantly fibroproliferative repair.~      Hypothesis~      Fibrosis of the lung is an aberrant and intensified form of wound healing. It is the result~     of an unresolved disturbance of both initiation and control of repair which is partly~     age-related. As a result of the relentlessly activated wound healing reaction, mechanisms of~     inflammation largely representing the condition of chronic inflammation within the peripheral~     bronchial tree will aggravate this abnormal form of repair.~      A systematic comparison of the molecular pathology of fibrotic repair representing~        -  Varying intensity of fibrosis related to the pathology of usual interstitial pneumonia~          (UIP),~        -  Varying inflammatory mechanisms (UIP vs. Hypersensitivity pneumonitis [HP], acute and~          chronic), and~        -  Varying stages of age (Normal pulmonary repair in young and old individuals vs.~          acute/chronic HP vs. UIP) will be able to~        -  identify molecules capable of shifting regular repair towards fibroproliferative repair~          and~        -  elucidate their interrelationship with other molecules forming coordinated yet~          misdirected metabolic responses characteristic for fibroproliferative repair.~   "
143583|NCT01687933|"~     There are different medicinal and non medicinal methods to control labor pain. Today, much~     attention has been on non medicinal methods because of limitations and complications of~     medical procedures. Virtual reality is a new and promising method of diversion of mind that~     may have an impact on labor pain. This study was conducted to determine the effect of virtual~     reality on the first stage of labor pain.~   "
143584|NCT01687920|"~     This study should estimate the dose proportionality of BAY94-8862 IR tablets.~   "
143585|NCT01687907|"~     The aim of this trial is to find out if active music listening during pregnancy and delivery~     reliefs fear of childbirth, pain in delivery, need for analgesia during delivery and if there~     is an effect on delivery complications. Also we try to find out if there is any influence on~     mother-baby relationship.~   "
143586|NCT01687894|"~     Patients undergoing surgery in beach chair position (BCP) are at risk for cerebral ischaemia.~     The impacts of arginine vasopressin (AVP) on haemodynamics and cerebral oxygenation are~     evaluated during surgery in BCP.~   "
143587|NCT01687881|"~     This study will highlight and validate chiropractic spinal manipulative therapy (CSMT) for~     cervicogenic headache (CEH). If the method proves to be effective, it will provide a new~     non-pharmacological treatment option for CEH. This is especially important since~     pharmacological management has minor effect in CEH, and alternative treatment options are~     warranted. The applied methodology of the study will aim towards the highest possible~     research standards. This international study is a collaboration between Akershus University~     Hospital, Innlandet Hospital and University of Oslo (UiO), Norway and Macquarie University,~     Australia. The multidisciplinary professional backgrounds are physiotherapy, chiropractic and~     medicine. By increasing the methodological quality of the investigators research to a very~     high level, the investigators see the method to work as a guide to increase the quality of~     chiropractic research in the future, as previous randomized clinical trials (RCTs) of CEH~     used methodology showing room for improvement.~      Study hypothesis:~      CSMT using the Gonstead method reduces days with CEH by at least 25% as compared to placebo~     (sham manipulation, i.e. broad non-specific contact, non-directional, low velocity and low~     amplitude) and no intervention (control group).~   "
143588|NCT01687868|"~     Patients undergoing shoulder arthroscopy in the beach chair position may be at risk for~     adverse neurologic events due to cerebral ischemia.~      Dexmedetomidine, a potent alpha adrenoceptor agonist which dose-dependently reduces arterial~     blood pressure and heart rate, decreases the hemodynamic and catecholamine response in the~     perioperative period.~      dexmedetomidine has an effect of peripheral vasoconstriction thus it is theologically~     appropriate for reducing bleeding for arthroscopic operation field.~      The aim of this study is to evaluate the efficacy and the safety of dexmedetomidine on~     cerebral oxygen saturation, cognitive function, hemodynamic stability and operative field in~     patients undergoing arthroscopic shoulder surgery in the beach-chair position.~   "
143589|NCT01687855|"~     The aim of this study was to evaluate the dynamic changes of the tongue in patients with~     obstructive sleep apnoea hypopnea syndrome (OSAHS) during sleep and while awake by using~     Ultrafast Magnetic Resonance Imaging (UMRI)~   "
143590|NCT01687842|"~     Monocentric multidisciplinary study (psychologists, endocrinologists, psychiatrists, and~     molecular biologists) to characterize social cognition in adolescents with Turner syndrome~     (TS).~      Inclusion criteria:~        -  Turner syndrome with homogeneous 45,X karyotype.~        -  Age between 8 and 18 years.~        -  Somatic state compatible with the evaluation.~        -  Functional language and IQ ≥ 80 for the transfer tests~        -  Informed consent signed by the holders of parental authority, the patient and the mother~          for her own participation (DNA collection).~        -  Affiliation to Social Security (beneficiary or assignee).~      The primary endpoint will be the overall score to the AQ (Autism Quotient) questionnaire and~     to the SRS (Social Reciprocity Scale), in comparison to the expected scores for the general~     population. For patients with scores above the threshold for SRS or QA validation of a~     possible diagnosis of autism spectrum disorders will be performed with commonly used~     diagnostic tools (ADIR (Lord et al, 1994), ADOS-G (Lord et al, 1999) and diagnostic criteria~     of DSM IV-TR).~      Secondary criteria will include the results of standardized tests to assess autistic features~     (AQ, ADI-R, ADOS, DSM IV-TR criteria), intellectual efficiency (Wechsler scales), psychiatric~     comorbidities (Kiddie-SADS) and sociocognitive profile (SpeX test, Social cognition,~     Perception, eXecutive functions).~      A DNA sample will be collected from the patient and her mother. The observation period is 2~     days for the patient and about 1 hour for the mother. The total duration of the study is 3~     years.~   "
143601|NCT01687699|"~     Aldosterone receptor blockers reduce cardiac-related morbidity and mortality. Recently, we~     demonstrated that long-term low-dose spironolactone is clinically safe in many hemodialysis~     (HD) patients. In the present study, we assess whether low-dose spironolactone treatment~     reduces the high incidence of cardio- and cerebrovascular (CCV) morbidity and mortality in HD~     patients. The investigators' hypothesis is that aldosterone receptor blockade by~     spironolactone reduces the risk of both CCV morbidity and death among HD patients.~   "
143592|NCT01687816|"~     This is a prospective specimen collection study targeting patients presenting with Influenza~     Like Illness (ILI) and/or Acute Respiratory Infection (ARI) in an out-patient setting. A~     non-invasive, user friendly sampling technique, using midturbinate flocked swabs will be~     used. These nasal swabs will be collected in different volumes of viral transport media~     (0.5mL and 3.0mL), for different dilution range of the viruses present in the collected~     biological specimen. The collection of nasal swabs samples will support the optimization of~     point of care detection methods for respiratory viruses responsible for ILI and/or ARI.~   "
143593|NCT01687803|"~     The overall goal of this study is to determine the health benefits associated with the 2005~     Dietary Guidelines physical activity prescription in healthy, peri-menopausal women. The 2005~     Dietary Guidelines specifically state that to avoid unhealthy weight gain, adults should~     participate in 60 minutes of moderate to vigorous intensity physical activity on most days of~     the week.~   "
143594|NCT01687790|"~     The primary hypothesis of this project is that using molecular breast imaging (MBI) in~     evaluating women with equivocal mammographic or sonographic findings will demonstrate high~     specificity in distinguishing benign from malignant breast disease and, as a result, decrease~     the number of biopsies.~   "
143595|NCT01687777|"~     Surgical reconstructive procedures for rotator cuff tears present a number of limitations.~     The few studies in which the repair integrity is evaluated, have shown the existence of a~     high rate of reruptures in spite of the fact that the functional results obtained short-term~     are satisfactory. Morphologic analysis from the sutures, after different follow-up periods,~     has not shown satisfactory results.~      Thus, the purpose of the current study was to test the hypotheses that mesenchymal stem cells~     (MSCs) included in a membrane into rotator cuff tears improves, the radiograms and the~     function compared to cell-free tendon defect treatment.~   "
143596|NCT01687764|"~     The objective of this project is to test the combination of active or placebo Attentional~     Bias Modification Treatment (ABMT) to either Cognitive Behavioral Group Therapy (CBGT) or~     Psychoeducational Control Intervention (PCI) for anxiety disorders in children.~   "
143597|NCT01687751|"~     Cancer patients with very difficult to control symptoms at the Abbotsford (AC) and Fraser~     Valley (FVC) Cancer Centers are referred and admitted to the Tertiary Palliative Care Units~     at the Abbotsford Regional Hospital and Cancer Center(ARHCC). For symptom management,~     patients are sometimes given midazolam continuously through a needle placed underneath the~     skin. While effective in symptom management, midazolam can be sedating, leaving patients~     unable to interact with loved ones in their last days.~      This study is a pilot project. Before proceeding to a full-scale study, a pilot study or~     feasibility study is often carried out first to test the design of a study, the likelihood~     of successful recruitment or the acceptability of the intervention to potential subjects. The~     basic idea is to find out whether it will be practical to proceed to a larger study that will~     include more subjects. This type of study involves only a small number of subjects and~     therefore the results can only be used as a guide for further larger studies.~      The investigators also will determine whether palliative care cancer patients taking a~     medication called dexmedetomidine would have improved rousability (more easily and fully~     awakened) and symptom control (pain, shortness of breath, nausea or confusion) compared with~     those taking standard of care which is receiving the medication midazolam. The use of~     dexmedetomidine in other clinical situations (in the Operating Room or Intensive Care Unit~     where the patient can still respond to the doctor) has been shown to be effective in symptom~     control and to provide a better degree of rousability to patients but has not been well~     studied in the palliative care environment.~   "
143598|NCT01687738|"~     Purpose: Overall lung surgery rates and black/white disparities have not improved during a~     decade of documentation. The goal of this study is to incorporate lessons from the previous~     prospective cohort study to optimize lung cancer surgery rates and narrow black-white~     disparities for patients diagnosed with stage I or II, non-small cell lung cancer.~      Participants: Stage I and II, non-small cell lung cancer at 3 participating sites.~     Procedures: Phase I of the study has been completed. Phase I was a deidentified 3-year,~     retrospective chart review, used to establish the baseline surgical rates for the~     intervention. The patient enrollment phase of the study will move forward that will include~     use of a real time registry to follow patient progression through clinical follow up,~     diagnostic testing and treatment for biopsy proven or highly probable early stage, non-small~     cell lung cancer. The patient enrollment portion of the study will start, September 2012. All~     patients with Stage I or II non-small cell lung cancer who enroll in the study will be~     entered into real time registries at every site. Patients' progress through the registries~     including follow-up provider visits, diagnostic tests, and procedures will be transparent and~     any missed appointments will be flagged. Feedback will be given to lung cancer providers in~     both arms. The randomized trial will compare patients who receive usual care plus the~     registry to those who receive the registry plus visits and calls from a trained cancer~     communicator -educator (CCE) who is well versed in issues specific to lung cancer and trained~     in active listening and communication that accounts for patients' limitations in health~     literacy. The CCE will also use Kleinman's Patient Model to identify attitudes or beliefs~     that represent barriers to recommended care that could potentially be addressed through~     negotiation and more targeted communication.~      The hypothesis is that an electronic warning system, data transparency, and enhanced~     communication will optimize lung surgery rates and reduce racial gaps.~   "
143599|NCT01687725|"~     In patients with treatment resistant hypertension renal nerve ablation emerged as an~     effective interventional approach of treating hypertensive disease with a progressively~     increasing fall in blood pressure. Decreased activity of the sympathetic nervous system is~     one of the major underlying pathogenetic mechanism of the fall in blood pressure but the~     precise mechanisms that causes the fall in blood pressure in the short-term and, in~     particular, long-term remains elusive. The objective of the study is to understand the~     pathogenetic mechanisms of renal denervation beyond the reduced activity of the sympathetic~     nervous system. In 100 hypertensive patients most advanced technology will be applied, before~     and repeatedly after renal denervation, throughout the follow-up period of 1 year. Systemic~     activity of the renin angiotensin aldosterone system, renal perfusion (by MRI spin labeling~     technique), local activity of the renin angiotensin system in the kidney (urinary~     angiotensinogen concentrations), sodium excretion and total sodium content (23 Na-MRI~     technique) and vascular remodelling of small (retinal arterioles 50 - 150 µm) and large~     arteries (carotid - femoral pulse wave velocity and augmentation index, both measured over 24~     hours) will be assessed. Identification of the pathogenetic mechanisms involved in the fall~     in blood pressure after renal denervation may help to identify those hypertensive patients~     that profit most from renal nerve ablation in terms of blood pressure reduction.~      The investigators propose the following hypotheses why a progressive decrease in blood~     pressure happens, in addition to the decreased activity of the central nervous system, after~     renal nerve ablation:~      Short term effects:~      A)Preservation of renal function and perfusion B)Reduction of local RAS activity in the~     kidney C)Exaggerated sodium excretion immediately after renal nerve ablation~      Long term effects:~      D)Decrease of total sodium content after 6 and 12 months E)Improvement of vascular wall~     properties after 6 and 12 months~   "
143600|NCT01687712|"~     The purpose of this study is to show that AFOLIA, a recombinant manufactured human follicle~     stimulating hormone (r-hFSH) has a similar efficacy and safety profile compared to Gonal-f®~     RFF.~   "
143602|NCT01687686|"~     The role of lipids as risk factors for cardiovascular events is well-documented, although~     events studied have largely been broad classes without specific detail. This study will~     examine a more refined set of endpoints.~   "
143603|NCT01687673|"~     This Phase II trial is being developed following the completion of a Phase I study of the~     combination of temsirolimus and sorafenib in 25 first-line therapy patients with advanced~     hepatocellular carcinoma (December 2009 through April 2012). The maximum tolerated dose (MTD)~     and recommended phase II dose (RP2D) of the combination of temsirolimus is 10 mg IV weekly~     plus sorafenib 200 mg (oral, twice daily).~   "
143604|NCT01687660|"~     Hypothesis: Acupuncture obtains an abiding effect on migraine prophylaxis Design: A~     open-label randomized controlled trial. 249 participants will be included. Three arms:~     acupuncture in acupoint-meridian， non-acupoint-meridian group, and waiting list.~   "
143605|NCT01687647|"~     Workers exposed to asbestos are at high risk of lung cancer. Medical follow-up of this~     population relies on repeated CT-scans which are more accurate for detection of peripheral~     lesions, and expose to X-rays and to risk of false-positives. Analysis of sputum using~     automate cytometry may be of interest in this population, alone or in combination with~     CT-scan.~      An ancillary study will evaluate the interest of blood predictive biomarkers.~   "
143606|NCT01687634|"~     In the Pico-Union/Koreatown community of Los Angeles investigators are designing a preventive~     health care model that increases the opportunities for families to make healthy choices -- in~     their homes, schools & communities. The project's key element is: Lay community health~     workers (paraprofessionals) - Mentor Mothers (MM) (promotoras) - who make home visits to~     pregnant mothers & newly-delivered mothers who have agreed to participate in the research~     study.~      Investigators hope to achieve the following outcomes: 1) lower maternal BMI at 6 months~     post-birth; 2) longer duration of breastfeeding; 3) less alcohol, smoking, and drug use~     during pregnancy; and 4) increased and consistent prenatal and postnatal healthcare~     adherence.~      Investigators will implement the study with 6 MMs, who will maintain an average caseload of~     16 women each across an 18-month period. Each participant will be visited (or receive the~     intervention by telephone) twice per month.~      Separate Assessment Team members will conduct assessments at: Baseline, within a week of~     birth of the target child, and 6 months from birth.~   "
143607|NCT01687621|"~     The objective of this study is to develop and test a simple community-based diagnostic~     algorithm for omphalitis in sub-Saharan Africa. To date, there has been no validated~     community-based algorithms developed and tested in the sub-Saharan context where the~     manifestations of omphalitis presentation may vary and diagnosis could be potentially more~     challenging in infants with darker skin color. Given the current attention to cord care at~     the global and national policy level, validated community-based algorithms will be needed to~     allow primary health workers to identify cord infections and reduce associated morbidity.~      After obtaining guardian informed consent, newborns aged 1-10 days presenting to the health~     facility for routine or sick visits will undergo two independent, parallel evaluations;~     first, by a community level worker and second, by a Zambian medical doctor (gold standard). A~     third independent assessment of a photo of the cord will be performed remotely by a~     board-certified pediatrician. Using the on-site clinician as the gold standard, the~     community-based algorithm and the photo assessment will be tested for concordance and the~     sensitivity and specificity of the algorithm will be generated. Likewise, the remote~     pictorial assessment will be compared to the gold standard to determine reliability of~     diagnosis from photographs alone.~   "
143608|NCT01687608|"~     The purpose of this study is to evaluate the safety of single ascending IV doses of a Factor~     IX (FIX) Gene Therapy in up to 16 Adults with Hemophilia B.~   "
143609|NCT01687595|"~     The purpose of this study is to evaluate the effect the HerpV vaccine has on recurring~     episodes of genital herpes by evaluating viral shedding before, after treatment.~   "
143610|NCT01687582|"~     The aim of the study is to evaluate after 4 to 6 months the effects of a GLP-1 analog~     treatment on psoriatic skin lesions in patients with type 2 diabetes.~   "
143611|NCT01687569|"~     The purpose of this study is to determine whether added ingredient affects glycaemic~     responses to a cracker snack.~   "
143612|NCT01687556|"~     Epigallocatechin-3-gallate (EGCG) may improve acne vulgaris~        -  major polyphenolic constituent in green tea~        -  known as potent anti-carcinogenic, anti-inflammatory, anti-proliferative, and~          antimicrobial activities~        -  lipid-lowering and antiandrogenic properties was reported~        -  EGCG can improve acne vulgaris via one of the above mentioned actions.~   "
143613|NCT01687543|"~     Symptoms of Clostridium difficile infection is almost always induced as a complication to the~     use of antibiotics. Most ICU patients are given antibiotics.~      Probiotics has the ability to improve conditions in the gut and it has been shown in some~     smaller studies that overgrowth of C. difficile can be reduced or prevented.~      In this study the intention is to show with sufficient statistical power that a mixture of~     two otherwise well studied probiotic strains reduces or prevents the incidence of emerging~     colonisation with C. difficile in critical ill patients on antibiotics.~      Half of the patients will be given a mixture of Lactobacillus plantarum 299 and Lactobacillus~     plantarum 299v twice daily and the rest a placebo mixture.~      Rectal swabs or faeces will be analysed for C.difficile and its toxins and the incidence of~     new cases will be compared for the two groups.~      White blood cells (WBC´s), C reactive protein (CRP), lactate, urea, and creatinine will be~     followed daily as well as antibiotics, corticosteroids and all acid reducing medication.~      Nutrition, enteral and total, and bowel habits will be recorded.~   "
143614|NCT01687530|"~     Certain types of fractures require surgical intervention that may involve the use of bone~     grafts or bone graft substitutes. Many of the materials used as bone graft substitutes suffer~     from disadvantages such as soft tissue invasion of the fracture area, inadequate blood~     supply, failure to encourage the production of bone and ectopic bone formation.~      A guided bone regeneration (GBR) environment may help in solving these clinical concerns. GBR~     has been widely used in the field of dentistry since the 1980s to provide stable placement~     for dental implants~      The purpose of this study is to evaluate the safety, performance and initial efficacy of~     Regenecure's, AMCA Bone Membrane, as a bone stimulating aid for orthopedic trauma~     applications.~   "
143659|NCT01686945|"~     This trial is conducted in Europe. The aim of the trial is to investigate safety,~     tolerability, pharmacokinetics (the exposure of the trial drug in the body), and~     pharmacodynamics (the effect of the investigated drug on the body) of multiple doses of a~     long-acting GLP-1 analogue (oral semaglutide) and a carrier in healthy male subjects and male~     subjects with type 2 diabetes (T2D).~   "
143615|NCT01687517|"~     Sarcoidosis is an inflammatory disease of unknown origin that can affect all organs,~     especially the lungs and mediastinum. Some location of sarcoidosis may require treatment with~     corticosteroids or immunosuppressors.Although seasonal influenza vaccination can be~     recommended in sarcoidosis in some subgroups at risk (respiratory failure, pulmonary~     fibrosis, age over 65, use of immunosuppressive therapy, etc ...), the investigators~     presently have no data on the efficacy and safety (absence of adverse reactions) of seasonal~     influenza vaccination in sarcoidosis.Especially it is not known whether the seasonal~     influenza vaccine provides the same rate and same type of vaccine response in sarcoidosis~     patients than in the general population. Similarly, it is unclear whether the vaccine~     response is modified by the severity of the disease and treatment with corticosteroids and~     immunosuppressors.Based on what is known in systemic lupus and rheumatoid arthritis, which~     are both inflammatory and autoimmune diseases, the investigators expect at best a 50% vaccine~     response in patients with sarcoidosis and a 85% vaccination response in healthy controls. The~     demonstration of a vaccine response could allow reconsidering new vaccine approaches in~     sarcoidosis.~   "
143616|NCT01687504|"~     Tuberculosis (also known as TB) is a common infection and a major cause of death in children.~     Effective treatment using a combination of anti-tuberculosis (anti-TB) medications saves~     lives, but dosages of these medications are not well established in children. Several~     research studies have shown that the recommended dosages of the anti-TB medications in~     children do not lead to adequate blood levels to kill the bacteria in some children. This~     situation may lead to treatment failure and emergence of drug resistance. As a result, the~     world Health Organization (WHO) recently recommended increased dosages for all the TB~     medications in children. This study is being conducted to find out if the increased dosages~     of the anti-TB drugs are safe and lead to adequate drug levels in the blood of children with~     TB with or without HIV infection.~   "
143617|NCT01687491|"~     This study is a clinical trial monocentric, open, randomized ENOXA ® versus LOVENOX ®,~     conducted on two parallel groups of patients admitted in emergency for acute coronary~     syndrome.~   "
143618|NCT01687478|"~     The purpose of this study is to assess the efficacy and safety of olanzapine and fluoxetine~     compared to placebo and fluoxetine as treatment for treatment-resistant depression (TRD) in~     Chinese participants.~   "
143619|NCT01687465|"~     Lasers are important therapy in glaucoma. They are a pivotal point in treatment between~     medical and surgical care. Over the last 10 years a new laser has emerged as the usual laser~     treatment: Selective laser trabeculoplasty (SLT). SLT works as well as the older laser used:~     argon laser trabeculoplasty (ALT). However SLT has many theoretical benefits over ALT~     including causing less damage to the tissue it affects. One of the potential patient centered~     benefits of this laser is that it may be repeatable. It is even possible that the old laser~     ALT may be useable after an SLT treatment. This study aims to uncover whether repeat laser is~     possible after SLT and if so which laser is more effective (ALT vs SLT). The potential of~     repeating laser therapies may delay surgical treatment and its complications. Also~     understanding which laser to use will help eye doctors know how to treat their patients at~     this point of the disease.~   "
143620|NCT01687452|"~     The aim of the investigators study is to demonstrate in healthy subjects and a cohort of~     patients infected with HIV, the presence of miRNAs in circulating peripheral blood~     microparticles (MPs).~   "
143621|NCT01687439|"~     Primary objective: functional imaging and quantitative imaging detection of the effects of~     Endostar combined with chemotherapy and radiotherapy on Non-small Cell Lung Cancer (NSCLC).~      Secondary objective: To evaluate 1) the role of Endostar in regulating tumor vessels and~     normalizing of microenvironment; 2) Toxicity of Endostar combined with chemotherapy.~   "
143622|NCT01687426|"~     The purpose of this study is to determine the intraocular Pressure (IOP) lowering response~     and evaluate the safety of brimonidine tartrate 0.025% ophthalmic solution in adult subjects~     with open angle glaucoma or ocular hypertension.~   "
143623|NCT01687413|"~     This clinical trial studies the intensity of adjuvant (helper) therapy required in p16~     positive oropharynx cancer patients, who have had all known disease removed surgically by a~     minimally invasive approach, and who have extracapsular spread in their lymph nodes. Patients~     can consent to participate in either the randomized (physician chooses radiotherapy arm or~     radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or~     radiotherapy & cisplatin arm) pathways. After the surgery, receive either radiation alone, or~     radiation and weekly cis-platinum during therapy. Patients are then followed for cancer,~     functional and quality of life outcomes.~   "
143624|NCT01687400|"~     This clinical trial studies potential genetic markers which might be used to predict which~     patients with acute myeloid leukemia or myelodysplastic syndromes respond to decitabine. This~     study will contribute to the efforts to find effective and less toxic therapies to provide~     durable remissions in a significant proportion of elderly AML patients.~   "
143625|NCT01687387|"~     Double-Blind Placebo-Controlled Randomized Phase 2 Study evaluating the efficacy of lirilumab~     (IPH2102/BMS-986015) as Maintenance Treatment administered in elderly patients with Acute~     Myeloid Leukemia (AML) in first complete remission~   "
143626|NCT01687374|"~     Hypothesis:~      The investigators want to study whether parathyroid hormone improves healing of humerus after~     a fracture. The investigators will assess healing of the humerus with Constant score.~   "
143637|NCT01687231|"~     In the transplant community, there is debate regarding the most appropriate food services for~     stem cell transplant patients. Recommendations regarding the use of low bacterial diets have~     been based on theoretical concepts of reducing the risk of contracting infections from~     pathogens found in food sources rather than clinical trials. The evidence for the use of a~     neutropenic diet is weak. To date, there have been little to no randomized controlled studies~     addressing the question whether a neutropenic diet in addition to prophylactic antibiotics is~     necessary as infection prevention in myeloablative stem cell transplant patients. For this~     reason, our research is aimed at providing data to substantiate the use of neutropenic diets~     in preventing infections in recipients of myeloablative stem cell transplants.~   "
143680|NCT01686672|"~     This study will demonstrate feasibility and collect pilot data via a pilot randomized trial~     of 20 participants on the effectiveness of a web-based delivery system of behavioral plus~     nutrition intervention for parents of children with Cystic Fibrosis (CF) ages 4 to 9 years of~     age that has been found to be efficacious in face to face delivery.~   "
143627|NCT01687361|"~     Neuromuscular electrical stimulation (NMES) is commonly used in rehabilitation contexts in~     order to increase or restore muscle capacities of hypoactive patients or patients with~     articular trauma. Although this technique seems to be particularly adapted to muscle~     rehabilitation, growing evidence is emerging regarding potential damaging effects of~     electrically- induced isometric contractions in healthy humans. Recent studies have reported~     a 10 to 30-fold increase in creatine kinase (CK) activity coupled to significantly increased~     muscle soreness and impaired force production as a result of NMESs. On that basis, further~     studies should be conducted on these deleterious effects which might limit the clinical~     application of NMES.~      Over the last decade, many studies paid attention to branched-chain amino acids (BCAA)~     supplementation as a potential prophylactic/therapeutic approach. The rationale of this~     approach is that BCAA might increase protein synthesis and reduce protein breakdown through~     physiological mechanisms involving mTOR regulation pathway (mammalian Target of Rapamycin).~     Additionally, BCAA could also be used as energetic substrate during exercise when glycogen~     stores are depleted. Overall, previous results have supported the efficacy of BCAA~     supplementation in attenuating muscle damage. Nevertheless, comprehensive studies~     investigating the effect of amino acid supplementation on markers of muscle damage are still~     scarce.~      Magnetic resonance imaging (IRM) and phosphorus 31 magnetic resonance spectroscopy (31P-MRS)~     are powerful non invasive tools allowing the exploration of skeletal muscle structure and~     energy metabolism.~      This ambitious project is devoted to the anatomical, functional and metabolic~     characterization of BCAA supplementation after NMES using MRI and 31P-MRS. Various markers of~     muscle damage, including maximal voluntary force production, T2 values and apparent diffusion~     coefficient (obtained by MRI) and energy metabolism assessed at rest and during exercise~     (using 31P-MRS), will be obtained before and after NMES. This project is of utmost importance~     for improving our knowledge of anatomic, metabolic and functional events related to BCAA~     supplementation in the context of exercise-induced muscle damage~   "
143628|NCT01687348|"~     Prospective, monocentric, open-label study conducted in women requiring mastectomy and~     eligible for tumescent infiltrative anaesthesia.~      Blood samples will be collected during 48h after start of infiltration. Total and free~     lidocaine concentrations measurements will be determined by gas chromatography. Visual~     analogic scale scores to evaluate postoperative pain and all data concerning analgesic drugs~     and adverse effects will be collected.~      Population pharmacokinetic parameters will be estimated using NONMEM software and covariates~     influence on parameters variability will be tested.~      Primary outcome value: Population pharmacokinetic parameters with possible covariates~     influence on variability.~      Patients and period of study: n=30 patients enrolled during 24 months, total study duration:~     30 months.~   "
143629|NCT01687335|"~     The prevalence of malnutrition in cancerous patients varies between 50% and 80%. It is~     variable in function: the location and the extension of the tumor, of the general state , of~     age, of the socio-economic class and the pain. The health consequences of a malnutrition are~     very important: aggravation of the state of health, complications of treatment,~     hospitalization, alteration of the quality of life and decrease the survival, and the~     treatment response.~      Nutrition being very important in patients, there are recommendations for the nutritional~     care of these patients, formulated by the European Society for Clinical Nutrition and~     Metabolism. The investigators do not know to what extent these recommendations are respected~     in practice and their influence on the nutritional status and the quality of life of~     patients.~      The investigators therefore propose to assess the conformity of the nutritional care patients~     in clinical practice in relation to the European recommendations and in a second time to~     assess the influence of this compliance or non-compliance on the nutritional status clinical~     and biological of cancerous patients under chemotherapy, on their quality of life, on their~     response to treatment and on their survival.~      The investigators will try to identify factors that may be linked to the non-compliance such~     as the characteristics of the cancer disease, socio-demographic characteristics of the~     subject and the factors related to the structure in which it is supported.~   "
143630|NCT01687322|"~     The investigators want to contact patients that underwent total hip replacement for the past~     ten years. The investigators will ask them about their daily living, functioning and quality~     of life.~   "
143631|NCT01687309|"~     A study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of~     single and repeat doses of 800 mg GSK2586184 in healthy subjects.~   "
143632|NCT01687296|"~     This is a multicentre, randomized, double-blind, double-dummy, active-controlled,~     parallel-group study to determine the efficacy and safety of nebulized fluticasone propionate~     1mg twice daily compared with oral prednisone administered for 7 days to Chinese pediatric~     and adolescent subjects (aged 4 to 16 years) with an acute exacerbation of asthma~   "
143633|NCT01687283|"~     This is a multicentre, randomized, single-blind, active-controlled, parallel-group phase III~     local registration study for a treatment period of 12 weeks. This study aims to assess the~     effectiveness and safety of fluticasone propionate 1mg via nebulizer BID in treatment of~     Chinese adult and adolescent patients with severe persistent asthma for a treatment period of~     12 weeks versus budesonide 2mg via nebulizer BID. The steady-state plasma pharmacokinetics of~     fluticasone propionate inhalation solution will also be assessed.~   "
143634|NCT01687270|"~     This is an open-label, single-arm study of sofosbuvir (GS-7977) and ribavirin (RBV) in adults~     who have had a liver transplant which has become re-infected with hepatitis C. The treatment~     period is 24 weeks with up to 48 weeks of follow up. The total time in this study will last~     up to 72 weeks not including the screening visit.~   "
143635|NCT01687257|"~     This study will evaluate the antiviral efficacy of combination therapy with sofosbuvir (SOF)~     plus ribavirin (RBV) for 48 weeks in adults with compensated and decompensated chronic~     hepatitis C virus (HCV) infection. Approximately 50 adults will be randomized (1:1) to~     receive study drug for 48 weeks or take part in an untreated observational arm for the first~     24 weeks followed by study drug for another 48 weeks.~   "
143636|NCT01687244|"~     This Phase 2 study is designed to assess the efficacy and safety of INSTILADRIN (rAd-IFN with~     Syn3) when given intravesically to patients with high grade non-muscle invasive bladder~     cancer who are refractory to or have relapsed from BCG therapy. The pharmacodynamics of~     INSTILADRIN will also be studied by measuring the interferon (IFNα2b) levels excreted in the~     urine. rAd-IFN is a non-replicating recombinant adenovirus type 5 (Ad5)-vector encoding the~     interferon alpha-2b (IFNα2b) gene. Syn 3 is clinical surfactant excipient which enhances the~     ability of the adenoviral vector to transfect cells in the bladder wall.~   "
143656|NCT01686984|"~     The purpose of this study is to investigate how inspiratory flow pattern influences CO2~     elimination in people without primary lung disease.~      The hypothesis is that a long mean distribution time, caused by a long postinspiratory pause~     and high end-inspiratory flow, will promote CO2 exchange in the alveoli.~   "
143657|NCT01686971|"~     A questionaire for cancer patients without an active treatment in order to evaluate their~     needs and/or demands.~   "
143638|NCT01687218|"~     MTN-017 is a Phase 2, multi-site, randomized, six-sequence, two three-period, open label~     crossover study, examining the effects of oral Truvada and reduced glycerin 1% tenofovir gel.~     The study population will be sexually active, HIV-uninfected males who are 18 years of age or~     older, who report a history of receptive anal intercourse in the past 3 months. Each of the~     study product regimens offers different advantages to participants seeking an effective HIV~     prevention agent. How these relative advantages will compare in terms of safety,~     acceptability, systemic and local absorption, and adherence will be examined within this~     study.~   "
143639|NCT01687205|"~     Study Objectives:~        -  To assess the impact of coitus (and semen) on the pharmacokinetics of tenofovir 1% gel~          in female genital tract secretions, vaginal and cervical tissue and rectal tract~          secretions~        -  To assess the impact of coitus (and semen) on pharmacodynamics of luminal drug by~          measuring the anti-HIV-1 activity in CVL samples~      Study Summary:~      MTN-011 will enroll heterosexual monogamous, sexually active couples, in which both partners~     are healthy and HIV-negative. The female participants must be between the ages of 21-46~     (inclusive) and currently using effective non-barrier contraception. Male participants must~     be 21 years of age or older. This Phase 1 expanded safety study will assess tenofovir PK in~     the genital tract secretions (CVL), rectal (rectal sponge) and both intracellular and~     extracellular tissue compartments (vaginal biopsy) in the absence of, or following coitus.~     Pharmacodynamics (antiviral activity) will also be assessed in CVL. MTN-011 will study the~     timing in which coitus might have the greatest impact on these variables, which is when gel~     is applied shortly prior to coitus in the absence of a drug reservoir.~      MTN-011 will examine PK/PD in response to a single dose of 1% tenofovir gel applied shortly~     before sex and compare to PK/PD assessments following a single gel application without sex.~     Additionally, data obtained from a visit in which participants do not dose with gel and do~     not have sex will serve as an additional control for the pharmacodynamic (PD) studies of the~     antiviral activity in CVL. If tenofovir retains its antiviral activity following sex, then~     the anti-HIV activity in CVL collected at the visit in which female participants dose with~     gel and have sex should be comparable to that of CVL collected at the visit in which females~     dose with gel and then do not engage in intercourse and significantly greater than the~     endogenous anti-HIV activity in CVL obtained at the visit in which participants do not dose~     with gel but do have sex and the visit in which no gel is administered and sex does occur.~     Data analysis performed after the completion of enrollment and follow-up procedures will~     demonstrate if there is an impact of coitus and semen on PK/PD when a single 1% tenofovir~     dose is applied shortly prior to sex.~   "
143640|NCT01687192|"~     PRIMAVERA is a Phase IIa clinical trial, with the objective to assess the immunologic~     response to HPV vaccine in a population of immunocompromised girls. The principal hypothesis~     is that the immunologic response to tetravalent vaccine in girls who received~     immunosuppressive treatment is comparable to the immunologic response in girls that are not~     immunosuppressed.~   "
143641|NCT01687179|"~     Specific Aim 1: To investigate whether, in Lymphangioleiomyomatosis (LAM) patients, the~     combination of sirolimus and hydroxychloroquine is safe and well tolerated~      Specific Aim 2: To investigate whether, in LAM patients, 6 months of combination therapy with~     sirolimus and hydroxychloroquine results in improvement of indicators of disease, and whether~     the gains are sustained after stopping therapy.~      Specific Aim 3: To investigate the potential role of a LAM-specific peripheral blood~     signature to predict rates of disease progression and determine responsiveness to combination~     therapy.~      This will be a phase I dose escalation study of the combination of sirolimus (2 mg adjusted~     to keep trough levels between 5-15 ng/ml) and hydroxychloroquine (200 mg or 400 mg) taken~     orally daily. Up to 18 adult women with LAM will be enrolled.~   "
143642|NCT01687166|"~     The purpose of this study is to establish the safety and effectiveness of the Blazer~     Open-Irrigated radiofrequency ablation catheter for the treatment of drug refractory,~     recurrent, symptomatic, paroxysmal atrial fibrillation.~   "
143643|NCT01687153|"~     Traumatic brain injury (TBI) and post traumatic stress disorder (PTSD) are common combat~     related problems and may be associated with a greater risk of Alzheimer's disease (AD). The~     purpose of this study is to examine the possible connections between TBI and PTSD, and the~     signs and symptoms of AD on Veterans as they age.~      The information collected will help to learn more about how these injuries may affect~     Veterans of the Vietnam War as they grow older, as well as Veterans of the current wars in~     Iraq and Afghanistan, who also have these types of combat related injuries.~   "
143644|NCT01687140|"~     Pediatric obsessive compulsive disorder (OCD) is a relatively common and often severe~     condition that can become chronic if untreated. One of the most effective treatments for OCD~     is a type of cognitive behavioral therapy called exposure and response prevention (ERP). ERP~     involves presenting a patient with feared objects or situations (the content of their~     obsessional fears) in a gradual manner while helping them use coping techniques to refrain~     from engaging in rituals (compulsions). Despite several studies suggesting that ERP is an~     effective treatment for pediatric OCD, many youngsters fail to respond to this treatment, or~     respond only partially.~      An exciting recent finding from animal research is the ability of an established antibiotic~     (traditionally used to treat Tuberculosis), D-cycloserine (trade name: Seromycin) to enhance~     certain types of learning among rats. The type of learning that is enhanced is called~     extinction learning and many researchers believe that extinction learning is the equivalent~     process to what occurs during ERP; it is the process whereby repeated exposure to the object~     of fear without any bad outcome causes the object to cease being associated with danger.~     Several clinical trials using ERP and other forms of exposure treatment for adults with~     anxiety disorders reproduced this finding from the animal literature; pairing DCS with~     exposure treatment (comparable to extinction learning) resulted in greater fear reduction~     than when no DCS was administered. The effects of DCS on exposure treatment for anxiety~     disorders among children has been tested only preliminarily in one study of children with OCD~     and results were unclear with children who received DCS augmentation showing non-significant~     but increased levels of improvement as compared with children who did not receive DCS~     augmentation.~      In this study, 26 youngsters ages 7-17 with a primary diagnosis of OCD will be recruited and~     assigned at random to one of the two treatment conditions. Youth in the DCS condition of the~     study will receive 50 mg DCS 1 hr prior to each treatment session, while youth in the placebo~     condition receive an identical placebo capsule 1 hr prior to each treatment augmentation~     session. All participants will receive 180 minutes of CBT for OCD 4 days per week for 2 weeks~     during their study participation (as included in IOP already). All families complete a~     thorough evaluation no more than 5 days prior to receiving DCS on their 9th treatment visit~     in IOP (third week), and at mid-treatment augmentation (after the 12th IOP treatment~     session), post-treatment augmentation (after the 16th IOP treatment session), and 3-month~     follow-up (12 weeks after the 16th IOP treatment session). The primary aim of this study is~     to obtain preliminary data comparing the effects of the acute administration of DCS versus~     placebo on symptom response to exposure treatment for pediatric OCD. Results from this study~     will help to inform and refine future studies, and eventually, impact treatments for~     pediatric OCD.~   "
143645|NCT01687127|"~     Periconceptional supplementation with folic acid - the synthetic form of the B-vitamin folate~     - reduces the occurrence of adverse pregnancy outcomes such as spina bifida. The underlying~     biochemical mechanisms for how folic acid affects health outcomes however are unknown. The~     naturally occurring form 5-methyltetrahydrofolate (5-MTHF) is now available and discussed as~     an adequate substitute to folic acid. This study aims to determine the effect of folic acid~     compared to 5-MTHF on cellular mechanisms. Stable isotope tracer protocols will be used that~     allow determining the effect of folic acid on the dynamics of metabolic pathways in the human~     body.~      Hypothesis: Supplementation with high-dose folic acid alters the turnover rate of folate~     dependent pathways in healthy humans; but 5-MTHF does not. Genetic variations in a key enzyme~     of the folate metabolism will aggravate the effect of folic acid on the metabolic pathways.~   "
143658|NCT01686958|"~     This study is to evaluate that the MRI-guided transurethral ultrasound therapy system is safe~     and feasible to ablate prostate tissue in men with localized prostate cancer.~   "
143646|NCT01687114|"~     This protocol is a clinical trial to validate proanthocyanidin A2 (PAC-A2) as a useful marker~     of cranberry intake. We hypothesize the consumption of this cranberry beverage in a~     progressive dosing schedule will increase PAC-A2 excretion in urine. Five generally healthy,~     nonsmoking, pre-menopausal women (absent major chronic diseases including cardiovascular,~     endocrine, gastrointestinal, and renal conditions), age 20-40 years, with a body mass index~     (BMI) of 18.5-25 kg/m2 will be recruited from the Boston area because sexually active women~     in this age range are particularly vulnerable to urinary tract infection. Volunteers will be~     asked to consume their assigned cranberry beverage at a dose of 8 oz/day according to a~     weekly dosing schedule. Relevant clinical information and eleven 24-hour and morning spot~     urine samples each will be collected from subjects during the study. Urinary PAC-A2~     concentration will then be determined to validate if it can serve as a marker of compliance~     of cranberry juice consumption.~   "
143647|NCT01687101|"~     This is an open label pilot study of 25 subjects with a diagnosis of episodic migraine with~     or without aura. STOPAIN is an over-the-counter product that is used for the temporary relief~     of minor aches and pains of muscles and joints associated with simple backache, arthritis,~     strains, bruises and sprains. We plan to have subjects apply the product during a single~     migraine attack to see if it will alleviate the headache pain and associated symptoms.~   "
143648|NCT01687088|"~     Olfactory impairment is a common symptom of neurologic disorders and may be related to~     dopaminergic dysfunction. Studies show that patients with migraine show increased sensitivity~     to light and sound. In our previous study in episodic migraineurs, olfaction was similar to~     age and sex-matched controls outside of attacks, but lower during acute attacks.~      The hypothesis is that olfactory function in chronic migraine (CM) will have mild impairment~     of olfaction at baseline but a more significant impairment during migraine or headache~     exacerbations.~      The investigators have two objectives:~        -  To determine baseline olfactory acuity in subjects with CM and compare them to age and~          sex-matched controls~        -  To determine how olfaction changes during acute exacerbations of migraine in those with~          CM~      To execute this study, the investigators will interview subjects and controls to ensure that~     they meet inclusion and exclusion criteria. After obtaining informed consent, subjects and~     controls will complete a questionnaire survey regarding their history or lack of history of~     headaches, smell sensitivity, osmophobia and current medication use and answer questions~     about attack frequency, location of headache, duration of disease, use of medication for~     pain, and disability. Both migraineurs and controls will take the University of Pennsylvania~     Smell Identification Test (UPSIT) in the office.~      After the first visit, migraineurs and controls will self-administer the UPSIT at home. They~     will be required to return the second test to the Jefferson Headache Center.~      The investigators will use analysis of variance (ANOVA) to determine variance in UPSIT scores~     between subjects and controls. To achieve a 90% power that the study will detect a~     statistically significant difference between the mean UPSIT scores at a two-sided 5 percent~     significance level, our sample size for both subjects and controls is 50.~   "
143649|NCT01687075|"~     The purpose of the study is to evaluate clinical performances of Cre8 in all comer population~     in Subjects over 18 years old who are undergoing a clinically indicated coronary angiogram~     and angioplasty on de-novo lesion located in native coronary arteries~   "
143650|NCT01687062|"~     Anemia is one of the most common health problems all over the world with around half of~     preschool-aged children (<5 years) and one third of women affected. Nutritional iron~     deficiency is a major reason for anemia in infants, young children and women of reproductive~     age who have especially high iron requirements that are difficult to meet in regions where~     the major diet is based on plant foods. So in Ethiopia, where injera is the major staple~     food. Despite high levels of iron in tef, the most favored cereal for injera, the iron~     bioavailability is assumed to be very low due to the high levels of phytic acid found in tef.~      The aim of this study is to determine the iron bioavailability in women from injera prepared~     in a traditional way and investigate the potential of methods to improve the bioavaiability.~     Therefore, a 50/50 and a 25/75 blend of FeSO4 and NaFeEDTA for iron fortification will be~     evaluated. Further the potential positive impact of phytic acid reduction on the iron~     bioavailability will be investigated. The phytic acid reduction will be achieved in two~     different ways, by addition of whole grain wheat as source of phytase and addition of a~     commercially available microbial phytase. The studies will be conducted in healthy women~     using stable isotope techniques.~   "
143651|NCT01687049|"~     Agents that inhibit cholesterol synthesis are being investigated in cancers dependent upon~     cholesterogenesis. Red yeast rice (RYR), is a reddish-purple fermented rice, containing~     statins which are known to inhibit cholesterol synthesis. Laboratory studies have also shown~     that RYR has direct effects on androgen dependent and androgen independent prostate cancer~     cells, inhibiting their growth. It is thought that RYR may have clinical benefit in those~     subjects with localized prostate cancer who have chosen to be managed by active surveillance.~   "
143652|NCT01687036|"~     Primary Endpoint Safety and tolerability of ablation using the AFreeze Cryoablation System~     consisting of the ablation CoolLoop® catheter, its steerable sheath and the cryoconsole~     Cryo-Caddy will be assessed and expressed in number of participants with Adverse Events~     (AEs).~   "
143653|NCT01687023|"~     The goal of this research study is to show that features derived from data gathered using~     SHIMMER wearable sensor platform can capture adherence and proficiency in the performance of~     exercises that are part of Tai Chi interventions.~   "
143654|NCT01687010|"~     Sepsis is a common cause for morbidity and mortality in critically ill patients. With the~     development of medical skills, the mortality is still remain very high. Inappropriateness of~     initial antibiotic treatment is an important risk factor for mortality and effective~     antimicrobial administration within the first hour of documented hypotension was associated~     with increased survival to hospital discharge in adult patients with septic shock. However,~     the early treatment based on early diagnosis.But it is very difficult to diagnosis because of~     lack of specific clinic symptom and sign.When severe sepsis occur, biomarker could be helpful~     to diagnosis. Unfortunately, the diagnostic value of single biomarker is limited. Therefore,~     combine several biomarkers could enhance the diagnostic value.~   "
143655|NCT01686997|"~     Morbid obesity is an increasing medical problem in the western countries. It's related to~     comorbidities as diabetes mellitus, hypertension, OSAS, arthrosis and hypercholesterolemia.~     The Roux-en-Y Gastric Bypass (RYGB) is an effective surgical therapy for morbidly obese~     patients. A part of these patients will have disappointing results, and have weight regain on~     the long term. Some studies show more weight reduction by increasing the biliopancreatic limb~     in patients with morbid obesity.~      The objective of this study is to investigate the effect of variations in the length of~     biliopancreatic limb on weight reduction in morbidly obese patients undergoing RYGB-surgery.~     We hypothesize that longer biliopancreatic limb results in more weight reduction.~      The study design is a prospective, randomized control trial. The patients will be randomized~     in 2 groups: a standard RYGB (short biliopancreatic limb) and long biliopancreatic limb RYGB.~   "
143660|NCT01686932|"~     Vildagliptin and Sitagliptin both belong to the class of DPP-4 inhibitors, but differ in~     their pharmacokinetic profile as well as in their approved application (Vildagliptin, 2x 50~     mg daily, Sitagliptin, 1x 100 mg daily). This leads to distinct results regarding~     postprandial blood-glucose normalization as well as protective properties regarding~     hypoglycemic episodes - especially during the night. Additionally, in type 1 diabetic~     patients a correlation has been described between hypoglycemia and abnormal heart function~     (QTc-elongation), which can have severe consequences for the patients. This study aims for~     the evaluation of the potency of both drugs to prevent and/or reduce hypoglycemic events in~     insulin-dependent type-2 diabetics and furthermore to evaluate the correlation of~     hypoglycemic episodes with changes in heart-function measured by Holter-ECG.~      The hypothesis is tested, if vildagliptin leads to a more favourable glycemic profile than~     sitagliptin and is more potent in protecting from nocturnal abnormalities in heart-function~     caused by undetected hypoglycemic episodes.~   "
143661|NCT01686919|"~     Innlandet Hospital in Gjøvik is a center for patients suffering from morbid obesity in~     Hedmark og Oppland, Norway. Patients with either BMI > 40 kg/m2 or with BMI > 35 kg/m2 and~     complications who opt for gastric bypass surgery, go through a standard program including a~     thorough clinical examination and information on the operation, followed by a learning and~     coping program that consists of standard dietary advise for weight loss and includes weekly~     visits during 8 weeks.~      This research project concerns a subgroup in the patient population described above: morbidly~     obese patients with irritable bowel syndrome (IBS). In this group it will be investigated how~     an 8 week preoperative milk-free diet affects digestive functions and weight loss. It is~     known that milk may cause stomach complaints and may make it more difficult to loose weight.~   "
143662|NCT01686906|"~     To evaluate the efficacy of mid-stromal implantation of an isolated Bowman layer graft, to~     reduce and stabilize ectasia in eyes with advanced keratoconus~   "
143663|NCT01686893|"~     Evaluation of Safety and Efficacy of Shorttime TNI Treatment in Patients with COPD Acute~     testing of oxygen demand using TNI vs. standard oxygen application in stable COPD patients An~     investigator-initiated, prospective, controlled, multicenter study~   "
143664|NCT01686880|"~     The purpose of this study is to assess the safety of transarterial radioembolization prior to~     surgical resection or radiofrequency in cirrhotic patients with hepatocellular carcinoma~   "
143665|NCT01686867|"~     The underlying concept behind this feasibility trial is to achieve a reduction in indoor~     smoke from biomass fuels and minimize changes in cooking practices such that it prompts one~     of the two improved, ventilated cookstoves to be the selection of choice. Typical fuel~     sources used in developing countries include wood, dried dung, and agricultural waste. The~     investigators propose to reduce indoor air pollution by replacing the household traditional~     cookstove with an improved design that incorporates the following key elements:~        -  Burner openings customized to the size and shape of the cooking vessels in the home.~        -  Flue designed to draw air into the fire box under the cooking pots and pass it out~          through a chimney.~        -  A chimney with adequate height to create a draft and vented to the exterior.~        -  An exterior port that has bidirectional openings to prevent backflow of smoke.~        -  An access port for the chimney that permits cleaning of soot.~      The investigators propose to use two types of improved cookstoves that meet these criteria.~     As part of piloting activities, the investigators will test several different types of~     commercially-available cookstoves with a chimney, and we may also want to test a locally-made~     improved cookstove. The investigators want to evaluate those designs by comparing their~     ability to reduce indoor air pollution, the reliability between cookstoves of the same type,~     the functioning over time, the logistics of import/build locally, preferences and cultural~     compatibility, and costs. The investigators will select two types of improved cookstoves to~     use in the feasibility trial.~      The study design will be a crossover intervention trial in which all patients will first have~     a run-in observational period of 4 months with the traditional cookstove prior to~     randomization. At baseline, the investigators will obtain sociodemographic information for~     each household, respiratory outcomes and other health data for the participating women, and~     cooking times and practices including the types of fuels used. All 40 patients at each site~     will receive the two types of improved cookstoves, one after the other: 20 will be randomized~     to receive the first type of cookstove with a chimney and the other 20 to first receive the~     second type of improved cookstove with a chimney. The patients will be followed for 4 months~     before the crossover. The investigators will assess cooking behavioral practices and~     compliance with cookstove use monthly, and respiratory and environmental measures at the~     mid-point of the 4 month period to minimize carry-over effects. At the end of second 4 month~     period, the investigators will switch the order of the improved cookstoves and follow all~     participants for another 4 months. The investigators will assess behavior, compliance,~     respiratory and environmental measures as above. The study is expected to require 12 months~     to complete.~   "
143666|NCT01686854|"~     Comparison between different treatments of obesity in the short and medium term: prescriptive~     diet therapy compared to to cognitive-behavioral approach in the treatment of obesity~     according to the method of clinical trial.~      According to the Italian guidelines on obesity, the target to reach is the weight loss of 10%~     compared to the initial weight, obtained in six months and maintained for the next 5 years.~      The guideline considers six months as the time required to lose weight, but many patients are~     not able to achieve this result. Since in clinical practice many patients fail to achieve~     this weight loss in six months, it was decided to extend to 12 months the time to reach the~     target. As an intermediate goal it has been proposed to achieve a weight loss of at least 5%~     on respect of the basal weight in six months.~   "
143667|NCT01686841|"~     To evaluate the safety and feasibility of reducing human sebum production using the ZELTIQ~     System.~   "
143668|NCT01686828|"~     The purpose of this research study is to understand the effects of testosterone and estrogen~     on the body's response to the hormone insulin.~   "
143669|NCT01686815|"~     This study aims to utilize state of the art procedures such as the frequently sampled~     intravenous glucose tolerance test (FSIVGTT), Bergman's Minimal Model Analysis, lipoprotein~     analysis, and DEXA scans to demonstrate that a newer agent, iloperidone, is devoid of the~     metabolic abnormalities associated with other atypical antipsychotic treatments, namely~     olanzapine and risperidone, and offers an advantage over these other agents.~   "
143670|NCT01686802|"~     Children 5-17 years of age who have undergo orthopedic day surgical procedures for definitive~     management of fractures, tendon release, etc. will be randomized to receive either ibuprofen~     or oral morphine as needed for pain relief for 48 hours post-operatively at home. Pain will~     be assessed using the self-report Faces pain scale revised (FPS-R). We hypothesize that oral~     morphine will result in significantly lower pain scores on the Faces Pain Scale Revised~     (FPS-R) compared to ibuprofen. It is hoped that the results of this trial will create a new~     option for post-operative pain management in children.~   "
143671|NCT01686789|"~     The study aims to study the outcome of pharmacokinetics-adjusted dose ribavirin (plus pegIFN)~     on the SVR in chronic HCV patients.~   "
143716|NCT01686204|"~     The main objective of this work is to conduct a clinical trial in obese and non-obese~     individuals testing the ability of low-fat dairy yogurt to improve gastrointestinal health~     and reduce chronic inflammation. Our central hypothesis is that short and long-term~     consumption of low-fat dairy yogurt will reduce inflammation to a greater extent in obese~     individuals by improving intestinal barrier function.~   "
143672|NCT01686776|"~     This is a prospective, validation study of a extempore made tracer compared with a~     commercial. Studies with tracer have no medical effects but are used for studying human~     physiology, in this case pharmacokinetic variables of endogenous albumin distribution and~     turnover at different levels of inflammation.~        1. Primary Objective:~           - Do the extempore made tracer 123-iodine labeled albumin an commercially manufactured~          SERALB-125 give identical values of calculated blood plasma volume and capillary leakage~          measured as transcapillary escape rate of albumin?~        2. Secondary Objective:~             -  How do three different measures of albumin turnover correlate in volunteers?~             -  How do the pharmacokinetic parameters of endogenous albumin vary between the three~               study groups?~   "
143673|NCT01686763|"~     Endothelin-1 (ET-1) seems to be involved in the pathogenesis of cerebral vasospasm after~     subarachnoid hemorrhage. However measurements of cerebrospinal fluid concentrations (CSF) of~     ET-1 are not sensitive enough to predict the development of vasospasm representing the~     average value throughout the entire cerebral circulation. Cerebral microdialysis (MD) is a~     technique able to detect molecule concentrations in a small perivascular area. The~     investigators performed a prospective observational clinical study to test the hypothesis~     that MD ET-1 concentrations should be a sensitive predictor for vasospasm.~      Patients with subarachnoid hemorrhage at high risk for vasospasm according to Fisher scale~     admitted to the ICU were consecutively studied. All patients received surgery within 48 hours~     from the bleeding; MD probe was placed in the area at risk for vasospasm after surgery and~     samples were hourly collected and analysed to measure lactate, piruvate and glutamate levels;~     ET-1 levels in CSF and MD fluids were measured from admission until day 7. At admission and~     after 7 days two angiographies were performed to detect the degree and extent of vasospasm,~     Transcranial Doppler and neurological evaluation were daily performed. Patients were then~     classified according to the presence of vasospasm in 3 groups: absence of vasospasm (NV),~     presence of vasospasm (CV), acute neurological deterioration (AND).~   "
143674|NCT01686750|"~     This is a cluster randomized trial to evaluate the effectiveness of integrated care centers~     (ICC) to improve access to HIV testing, prevention services, and treatment among high-risk~     populations of injection drug users (IDU) and men who have sex with men (MSM) in India. We~     will collect baseline ethnographic and survey data from approximately 27 IDU or MSM sites in~     India. We will use baseline data to select 22 sites for the trial (12 IDU and 10 MSM) and to~     stratify sites according to key baseline characteristics. We will perform stratified~     randomization to assign sites to either the ICC intervention or to standard services. ICCs,~     which will be either IDU or MSM-focused, will provide an accepting atmosphere in which~     members of vulnerable groups can drop-in, receive rapid HIV voluntary counselling and~     testing, risk reduction counseling and services, and antiretroviral therapy. ICCs will be~     scaled-up from existing governmental or non-governmental organizations and services provided~     at ICCs will be supported by the National AIDS Control Organization (NACO) of India. After~     providing services in communities for two years, we will conduct an evaluation survey (with~     biological and behavioral measures) of approximately 1000 subjects in the target populations~     in each of the 22 study sites. Integrated care centers have the potential to improve access~     to HIV prevention and treatment services among vulnerable, high-risk populations.~   "
143675|NCT01686737|"~     Breast cancer is the most frequent cancer in women and is associated with profound~     restrictions of health-related quality of life and psychosocial health. More than~     three-quarters of women with breast cancer suffer from fatigue during cancer treatment. While~     exercise interventions can improve fatigue in breast cancer patients, many patients request~     complementary treatment approaches. Therefore, this study investigates the effects of yoga in~     women with breast cancer compared to aerobic exercise and usual care.~      It is hypothesized that yoga is more effective than usual care and equally effective as~     aerobic exercise.~   "
143676|NCT01686724|"~     This study tests the effectiveness of a newly developed integrated school-home behavioral~     intervention for behaviors related to Attention Deficit Hyperactivity Disorder (ADHD). The~     intervention is implemented by school-based mental health professionals within school~     settings.~   "
143677|NCT01686711|"~     To evaluate the efficacy and safety of coadministration AD-4833 and SYR-322 in patients with~     diabetes mellitus.~   "
143678|NCT01686698|"~     Probiotics, due to their ability to modulate intestinal flora, intestinal permeability and~     immune response, could decrease bacterial translocation and improve immune system alterations~     in cirrhosis. This could lead not only to improvement in liver function and to prevent~     bacterial infections and other complications but also to improve CD and to avoid its~     consequences falls, HRQoL deterioration).~      Recently, the investigators have observed that VSL#3 administration to rats with experimental~     cirrhosis decreases bacterial translocation, inflammatory response and ascites formation,~     without changes in intestinal flora. This suggests an improvement in intestinal barrier that~     deserves further investigation.~      VSL#3, through decreasing intestinal bacterial translocation and immune system modulation,~     could improve cognitive function and prevent the consequences of CD, including falls and~     HRQoL deterioration, in patients with cirrhosis.~   "
143679|NCT01686685|"~     Preterm children are at increased risk for autism spectrum disorders, with an estimated rate~     of 10%. In the US, about 1 in 8 pregnancies ends with a premature birth. Therefore,~     individuals with ASD who were born prematurely form a substantial body of children diagnosed~     with ASD.~      Premature birth confers an insult to the newborn at a neurologically vulnerable stage.~     Prematurity associated changes in oxygen tension can be detrimental to developing organs, the~     brain being one of the most rapidly developing organs in the second half of the pregnancy.~     Changes in oxygen tension mediate activation of proteins that change the course of cell~     development.~      In this study, we plan to measure changes in the expression of 3 proteins that may be~     affected by changes in oxygen level at birth. We will study the interaction between the~     proteins' levels in the first few days after premature birth with a diagnosis of ASD at 2~     years of age. The proteins are:~        1. VEGF (Vascular Endothelial Growth Factor), a protein that takes part in creating new~          blood vessels during embryonic development.~        2. Hypoxia-inducible factor -1(HIF-1), a key protein that coordinates expression of~          different genes, many with developmentally critical functions.~        3. CXCR4, a cell surface protein that is activated by SDF-1. SDF- 1 is a molecule that~          regulates migration of cells to their target destination during embryonic life. CXCR4 is~          expressed in areas of the brain and on cells that are known to be associated with ASD.~      We hypothesis that changes in oxygen tension in premature babies initiates a cascade of~     events that lead to changes in cell mobility via abnormal CXCR4 expression. This change leads~     to abnormal neurodevelopment.~      The investigators' primary aim is to find if there is a correlation between postnatal levels~     of expression of HIF-1, CXCR4 and VEGF and a diagnosis of autism at age 24 months. The~     investigators' secondary aim is to find if there is a correlation between postnatal levels of~     expression of HIF-1, CXCR4 and VEGF and a language or neurocognitive delay.~      Methods:~        1. Premature babies will be recruited in the first day post delivery.~        2. Blood samples will be collected at 3 time points during their hospitalization, and the~          expression of HIF-1, CXCR4 and VEGF will be determined.~        3. Infants will undergo a complete developmental evaluation at 18-24 months of age .~        4. Postnatal levels of HIF, CXCR4 and VEGF will be plotted against the results of the~          developmental evaluation.~   "
143681|NCT01686659|"~     This is a multi-center cluster-randomized trial with the following Specific Aims:~        -  To evaluate if continuous noninvasive hemoglobin monitoring will reduce the RBC~          transfusions in patients undergoing surgeries associated with a significant risk of~          bleeding.~        -  To evaluate if patients monitored with continuous noninvasive hemoglobin experience less~          frequent complications and shorter hospital stay compared with patients who are not~          being monitored with continuous noninvasive hemoglobin.~      Accordingly, the study hypotheses are defined as follows:~        -  The primary null hypothesis is that continuous noninvasive hemoglobin monitoring will~          not reduce the RBC transfusions in patients undergoing surgeries associated with a~          significant risk of bleeding.~        -  The secondary hypothesis is that in patients monitored with continuous noninvasive~          hemoglobin, there will be earlier warning of critical drops in hemoglobin, and thus,~          there will be less frequent complications compared with patients who are not being~          monitored with continuous noninvasive hemoglobin.~   "
143682|NCT01686646|"~     This study will investigate any improvement in alertness and performance based on cognitive~     function and mood assessment in subjects suffering the common cold, when taking a novel~     paracetamol and caffeine combination verses paracetamol alone.~   "
143683|NCT01686633|"~     This is a Phase III, multicenter, randomized, double-blind, stratified, parallel-group study~     with three active comparators in subjects with moderate to severe persistent asthma. The~     study consists of a run-in period of 4 weeks, followed by a treatment period of 12 weeks, and~     a follow up contact period of one week. The total duration of the study is 17 weeks. 990~     subjects will be randomized to one of three treatments (FF/VI Inhalation Powder 200/25 mcg~     once daily in the evening; FF/VI Inhalation Powder 100/25 mcg once daily in the evening; FF~     100 Inhalation Powder once daily in the evening) for 12 weeks. In addition, all subjects will~     be supplied albuterol/salbutamol inhalation aerosol at Visit 1 to use as needed for acute~     asthma symptoms throughout the entire study. Subjects will attend four on-treatment visits at~     Weeks 2, 4, 8, and 12 (Visits 4 through 7).~   "
143684|NCT01686620|"~     The purpose of this study is to evaluate the safety and efficacy of BIOD-123 compared to~     insulin lispro (Humalog®) when used as part of a basal-bolus regimen in patients with type 1~     diabetes.~   "
143685|NCT01686607|"~     This multicenter observational cohort study proposes to establish the risks of short and~     long-term outcomes in users of parenteral micafungin and in users of other parenteral~     antifungal agents from 2005 through 2012 with follow-up until 2017.~   "
143686|NCT01686594|"~     The purpose of the study is to determine whether psoralen plus UVA (PUVA) photochemotherapy~     maintenance treatment prolongs disease-free survival of cutaneous T cell lymphoma (mycosis~     fungoides) patients.~   "
143687|NCT01686581|"~     This is an observational study to describe the long term use of Onabotulinumtoxin A (BOTOX®)~     as prescribed by the physician for headache prophylaxis in adults with chronic migraine. All~     treatment decisions lie with the physician.~   "
143688|NCT01686568|"~     This study is being done to understand the effects of dietary omega-3 fats on insulin~     sensitivity in adult men and women.~   "
143689|NCT01686555|"~     To assess the safety, tolerability and pharmacokinetics of ABT-199 in female subjects with~     Systemic Lupus Erythematosus.~   "
143690|NCT01686542|"~     The study is designed as a randomized control trial. The purpose of this study is to observe~     the efficacy and safety of atrial fibrillation ablation, comparing circumferential pulmonary~     vein isolation (CPVI) plus renal sympathetic modification (RSM) with CPVI alone.~   "
143691|NCT01686529|"~     The aim of this study was to investigate the efficacy and safety of subconjunctival~     bevacizumab application as an adjuvant therapy for primary pterygium.~   "
143692|NCT01686516|"~     Diffusion MRI employed in functional imaging has the potential to probe directly brain~     activation instead of blood changes like the BOLD technique. The researchers investigated~     these rapid synaptic plasticity changes with visual activation followed by BOLD and diffusion~     functional MRI as well as anatomical (venography, tractography by diffusion) features in~     young and aged subjects.~   "
143693|NCT01686503|"~     The purpose of this study is to determine whether a lower dose of inactivated polio vaccine~     (IPV) injected into the skin (intradermal administration) can work equally well or better~     than the standard dose injected into the muscle (intramuscular administration). There are~     more immune cells in the skin than in the muscle, and other vaccines have been shown to~     require a lower dose when administered intradermally. The study is being done in participants~     infected with HIV because HIV-infected people are known to respond less well to vaccines than~     other groups, so it is particularly important to know if IPV might work better in~     HIV-infected people if administered intradermally.~      If it is possible to lower the dose of IPV by intradermal administration, this would make~     inactivated polio vaccine more affordable in the developing countries where it is most needed~   "
143694|NCT01686490|"~     The purpose of this trial was to develop the initial sections of a video/DVD cassette that~     provided guidance about mastering stressful situations for patients who had been informed~     that they need an implantable cardioverter-defibrillator (AICD). We adapted the existing~     LifeSkills video (which was already been shown effective in patients with heart diseases) to~     the specific needs of patients with AICD's. Before its development, we held separate focus~     groups with healthcare providers of AICD patients, pre-implantation patients, and~     post-implantation patients. After the video/accompanying workbook was produced, we held an~     additional focus group with patients who had received the video/workbook before receiving~     their AICD.~   "
143695|NCT01686477|"~     Mother's Own Milk (MOM) is recommended for preterm babies. However, on average, mothers~     giving birth preterm are able to provide less than half their baby's milk requirements.~     Standard clinical practice is to make up any shortfall in MOM with either pasteurised Human~     Donor Milk (HDM) or Preterm Formula (PTF). Which option is more beneficial to clinical~     outcomes is unknown.~      Pasteurisation reduces or destroys many biologically active components and HDM, unlike PTF,~     is very variable in composition. Clinicians who use HDM do so primarily in the hope that~     despite pasteurisation it will reduce bloodstream infection and necrotising enterocolitis, a~     serious, devastating inflammatory disease characterised by bowel death and multisystem~     failure. These are two of the most feared conditions in newborn medicine as described above.~     Landmark nutritional trials in the early 1980's suggest positive effects of human milk on~     insulin sensitivity, and other metabolic outcomes. Clinicians who prefer PTF believe it~     benefits growth, including brain growth, and improves neurodevelopmental outcome.~      In order to address this crucial question, central to preterm newborn care, a multicentre~     United Kingdom (UK) -wide study randomising 4000 preterm babies would be necessary to achieve~     sufficient power to evaluate the impact on the short-term outcomes necrotising enterocolitis~     and bloodstream infection, and establish cohorts large enough to address long-term metabolic~     (such as obesity, type 2 diabetes), cardiovascular (such as blood pressure) and developmental~     outcomes. This pilot trial will evaluate the practicability and feasibility of such a large~     multicentre UK randomised controlled trial. In addition to evaluating feasibility and to~     ensure maximal use of resources allocated, this study will also assess outcomes that are~     indicative of long term metabolic health.~      Neonates born below 32 weeks gestational age will be randomised to receive fortified HDM,~     unfortified HDM, or PTF to make up any shortfall in MOM until 35 weeks postmenstrual age with~     a sample size of 22 in each group. The trial is designed to reflect current preterm feeding~     practice. The trial will take place in neonatal units in London and parent consent obtained~     within 48hr of birth. Permission will be sought for long term follow up, initially from~     parents (later from children themselves). Outcomes will be body composition using magnetic~     resonance imaging and other imaging techniques. This pilot study will specifically assess~     feasibility by testing 1) provision of HDM by Human Milk Banks in London 2) acceptability to~     parents and clinicians using feedback on trial design 3) recruitment to target and 4)~     retrieval of clinical data for all recruited babies form the National Neonatal Database.~   "
143696|NCT01686464|"~     The aim of this clinic trial is to testify the efficacy of using new and noninvasive therapy,~     called simultaneous Magnetic and Oxygen Treatment along Meridians and Collaterals (MOMC),~     to treat Bell's Palsy.~   "
143697|NCT01686451|"~     Both XueZhiKang and Statins are cholesterol-lowering medications that are often prescribed~     for individuals with high cholesterol and who are at risk for cardiovascular disease (CVD).~     Several studies, including one randomized, double-blind, placebo-controlled clinical trial,~     have suggested that the use of statins is more frequently associated with fatigue. And~     XueZhiKang may be not. The purpose of this study is to compare the effect of these two~     medications on fatigue in persons who are at moderate to low CVD risk based on the risk~     estimation system in ESC(European Society of Cardiology)/ESA(European Atherosclerosis~     Society) guidelines (2011) for the management of dyslipidemias.~   "
143698|NCT01686438|"~     Insomnia is commonly present in Veterans with post-traumatic stress disorder (PTSD).~     Treatment of insomnia with a specialized type of psychotherapy has been shown to be more~     effective than treatment with medications. Unfortunately, few psychologists are trained to~     provide this treatment, limiting Veterans' access to care, especially those Veterans in~     remote and rural areas. This project will evaluate the ability to deliver this psychotherapy~     to groups of Veterans by video teleconferencing. Groups of Veterans with PTSD and chronic~     insomnia will receive the psychotherapy treatment either by meeting in-person with the~     psychologist or by the psychologist delivering the treatment by video teleconferencing.~     Finding that video teleconferencing is a cost effective way to deliver this treatment could~     add an important new component to the care of Veterans with PTSD that provides an alternative~     to medications.~   "
143699|NCT01686425|"~     Patients with obstructive jaundice due to locally advanced/metastatic malignancy with dilated~     intrahepatic bile ducts will be recruited from the department of Gastroenterology and~     Hepatology at the University Hospital of Leuven.~      This population will have failed ERCP or will be considered when ERCP is not possible due to~     altered surgical anatomy.~      Patients will be randomized to either PTC or EUS guided biliary drainage~   "
143700|NCT01686412|"~     This is an exploratory study, national, unicentric, double-blind, to be conducted at the~     Institute for Teaching and Research of the Hospital Sírio-Libanês in order to detect possible~     autonomic responses resulting from Exposure to Electromagnetic Fields of Low Energy (EEFLE)~     in healthy subjects and in patients with advanced hepatocellular carcinoma or in patients~     with advanced breast carcinoma. Autonomic responses have been described in patients with~     cancer during the exposure of EEFLE. This autonomic response, or biofeedback, due to exposure~     to EEFLE seems to be associated with a specific set of modulation frequencies when applied to~     patients with malignancies. Moreover, healthy individuals exposed to modulated EEFLE a~     specific set of frequency do not appear to autonomic response. Biofeedback is defined by a~     change in amplitude of the radial pulse during exposure to EEFLE, modulated according to a~     set of specific frequencies. This phenomenon is not yet fully elucidated. In exploratory~     survey of one patie